###24293578
OBJECTIVE	To investigate the efficacy of 6 weeks of daily low-dose oral prednisolone in improving pain , mobility , and systemic low-grade inflammation in the short term and whether the effect would be sustained at 12 weeks in older adults with moderate to severe knee osteoarthritis ( OA ) .
METHODS	A total of 125 patients with primary knee OA were randomized 1:1 ; 63 received 7.5 mg/day of prednisolone and 62 received placebo for 6 weeks .
METHODS	Outcome measures included pain reduction and improvement in function scores and systemic inflammation markers .
METHODS	Pain was assessed using the visual analog pain scale ( 0-100 mm ) .
METHODS	Secondary outcome measures included the Western Ontario and McMaster Universities Osteoarthritis Index scores , patient global assessment ( PGA ) of the severity of knee OA , and 6-min walk distance ( 6MWD ) .
METHODS	Serum levels of interleukin 1 ( IL-1 ) , IL-6 , tumor necrosis factor ( TNF ) - , and high-sensitivity C-reactive protein ( hsCRP ) were measured .
RESULTS	There was a clinically relevant reduction in the intervention group compared to the placebo group for knee pain , physical function , PGA , and 6MWD at 6 weeks .
RESULTS	The mean difference between treatment arms ( 95 % CI ) was 10.9 ( 4.8-18 .0 ) , p < 0.001 ; 9.5 ( 3.7-15 .4 ) , p < 0.05 ; 15.7 ( 5.3-26 .1 ) , p < 0.001 ; and 86.9 ( 29.8-144 .1 ) , p < 0.05 , respectively .
RESULTS	Further , there was a clinically relevant reduction in the serum levels of IL-1 , IL-6 , TNF - , and hsCRP at 6 weeks in the intervention group when compared to the placebo group .
RESULTS	These differences remained significant at 12 weeks .
RESULTS	The Outcome Measures in Rheumatology Clinical Trials-Osteoarthritis Research Society International responder rate was 65 % in the intervention group and 34 % in the placebo group ( p < 0.05 ) .
CONCLUSIONS	Low-dose oral prednisolone had both a short-term and a longer sustained effect resulting in less knee pain , better physical function , and attenuation of systemic inflammation in older patients with knee OA ( ClinicalTrials.gov identifier NCT01619163 ) .

###24854809
BACKGROUND	Emotional eating is associated with overeating and the development of obesity .
BACKGROUND	Yet , empirical evidence for individual ( trait ) differences in emotional eating and cognitive mechanisms that contribute to eating during sad mood remain equivocal .
OBJECTIVE	The aim of this study was to test if attention bias for food moderates the effect of self-reported emotional eating during sad mood ( vs neutral mood ) on actual food intake .
OBJECTIVE	It was expected that emotional eating is predictive of elevated attention for food and higher food intake after an experimentally induced sad mood and that attentional maintenance on food predicts food intake during a sad versus a neutral mood .
METHODS	Participants ( N = 85 ) were randomly assigned to one of the two experimental mood induction conditions ( sad/neutral ) .
METHODS	Attentional biases for high caloric foods were measured by eye tracking during a visual probe task with pictorial food and neutral stimuli .
METHODS	Self-reported emotional eating was assessed with the Dutch Eating Behavior Questionnaire ( DEBQ ) and ad libitum food intake was tested by a disguised food offer .
RESULTS	Hierarchical multivariate regression modeling showed that self-reported emotional eating did not account for changes in attention allocation for food or food intake in either condition .
RESULTS	Yet , attention maintenance on food cues was significantly related to increased intake specifically in the neutral condition , but not in the sad mood condition .
CONCLUSIONS	The current findings show that self-reported emotional eating ( based on the DEBQ ) might not validly predict who overeats when sad , at least not in a laboratory setting with healthy women .
CONCLUSIONS	Results further suggest that attention maintenance on food relates to eating motivation when in a neutral affective state , and might therefore be a cognitive mechanism contributing to increased food intake in general , but maybe not during sad mood .

###25165090
BACKGROUND	Although working smoke alarms halve deaths in residential fires , many households do not keep alarms operational .
BACKGROUND	We tested whether theory-based education increases alarm operability .
METHODS	Randomised multiarm trial , with a single arm randomly selected for use each day , in low-income neighbourhoods in Maryland , USA .
METHODS	Intervention arms : ( 1 ) Full Education combining a health belief module with a social-cognitive theory module that provided hands-on practice installing alarm batteries and using the alarm 's hush button ; ( 2 ) Hands-on Practice social-cognitive module supplemented by typical fire department education ; ( 3 ) Current Norm receiving typical fire department education only .
METHODS	Four hundred and thirty-six homes recruited through churches or by knocking on doors in 2005-2008 .
METHODS	Follow-up visits checked alarm operability in 370 homes ( 85 % ) 1-3 .5 years after installation .
METHODS	number of homes with working alarms defined as alarms with working batteries or hard-wired and number of working alarms per home .
METHODS	Regressions controlled for alarm status preintervention ; demographics and beliefs about fire risks and alarm effectiveness .
RESULTS	Homes in the Full Education and Practice arms were more likely to have a functioning smoke alarm at follow-up ( OR = 2.77 , 95 % CI 1.09 to 7.03 ) and had an average of 0.32 more working alarms per home ( 95 % CI 0.09 to 0.56 ) .
RESULTS	Working alarms per home rose 16 % .
RESULTS	Full Education and Practice had similar effectiveness ( p = 0.97 on both outcome measures ) .
CONCLUSIONS	Without exceeding typical fire department installation time , installers can achieve greater smoke alarm operability .
CONCLUSIONS	Hands-on practice is key .
CONCLUSIONS	Two years after installation , for every three homes that received hands-on practice , one had an additional working alarm .
BACKGROUND	http://www.clinicaltrials.gov number NCT00139126 .

###24633056
OBJECTIVE	To evaluate the performance ( efficacy , safety and acceptability ) of a new micro-adherent absorbent dressing ( UrgoClean ) compared with a hydrofiber dressing ( Aquacel ) in the local management of venous leg ulcers , in the debridement stage .
METHODS	A non-inferiority European randomised controlled clinical trial ( RCT ) was conducted in 37 centres , on patients presenting with venous or predominantly venous , mixed aetiology leg ulcers at their sloughy stage ( with more than 70 % of the wound bed covered with slough at baseline ) .
METHODS	Patients were followed over a 6-week period and assessed weekly .
METHODS	The primary judgement criteria was the relative regression of the wound surface area after the 6-week treatment period .
METHODS	Secondary endpoints were the relative reduction of sloughy tissue and the percentage of patients presenting with a debrided wound .
RESULTS	Altogether , 159 patients were randomised to either UrgoClean ( test group ; n = 83 ) or Aquacel ( control group ; n = 76 ) dressings .
RESULTS	Regarding the wound healing process predictive factors ( wound area , duration , ABPI value , recurrence ) , at baseline , the two groups were well balanced , for both wound and patient characteristics .
RESULTS	Compression therapy was administered to both groups and after a median 42-day treatment period , the percentage of relative reduction of the wound surface area was very similar ( -36.9 % vs -35.4 % in the UrgoClean and control groups , respectively ) .
RESULTS	When considering the secondary criteria at week 6 , the relative reduction of sloughy tissue was significantly higher in the UrgoClean group than in the control group ( -65.3 % vs -42,6 % ; p = 0.013 ) .
RESULTS	The percentage of debrided wounds was also significantly higher in the test group ( 52.5 % vs 35.1 % ; p = 0.033 ) .
CONCLUSIONS	This ` EARTH ' RCT confirmed that the UrgoClean dressing has similar efficacy and safety compared to Aquacel .
CONCLUSIONS	However , UrgoClean also showed better autolytic properties than the control group in the management of venous leg ulcers at the sloughy stage .
CONCLUSIONS	The new UrgoClean dressing therefore represents a promising therapeutic option within the current range of autolytic dressings available .
BACKGROUND	This study was sponsored by a grant from the pharmaceutical company Laboratoires Urgo .
BACKGROUND	S. Bohbot and O. Tacca are employees of Laboratoires Urgo .
BACKGROUND	S. Meaume , J. Dissemond and G. Perceau have received monetary compensation as presenters for Laboratoires Urgo .
BACKGROUND	Data management and statistical analyses were conducted independently by Vertical ( Paris , France ) .

###24814304
OBJECTIVE	Eye movements ( EM ) during recall of an aversive memory is a treatment element unique to Eye Movement Desensitization and Reprocessing ( EMDR ) .
OBJECTIVE	Experimental studies have shown that EM reduce memory vividness and/or emotionality shortly after the intervention .
OBJECTIVE	However , it is unclear whether the immediate effects of the intervention reflect actual changes in memory .
OBJECTIVE	The aim of this study was to test whether immediate reductions in memory vividness and emotionality persist at a 24h follow up and whether the magnitude of these effects is related to the duration of the intervention .
METHODS	Seventy-three undergraduates recalled two negative autobiographical memories , one with EM ( `` recall with EM '' ) and one without ( `` recall only '' ) .
METHODS	Half of participants recalled each memory for four periods of 24s , the other half for eight periods of 24s .
METHODS	Memory vividness/emotionality were self-rated at a pre-test , an immediate post-test , and a 24h follow-up test .
RESULTS	In both duration groups , recall with EM , but not recall only , caused an immediate decrease in memory vividness .
RESULTS	There were no immediate reductions in memory emotionality .
RESULTS	Furthermore , only the ` eight periods ' group showed that recall with EM , but not recall only , caused a decrease in both memory emotionality and memory vividness from the pre-test to the follow-up .
CONCLUSIONS	Only self-report measures were used .
CONCLUSIONS	The findings suggest that recall with EM causes 24-hchanges in memory vividness/emotionality , which may explain part of the EMDR treatment effect , and these effects are related to intervention duration .

###25825539
OBJECTIVE	Few studies have tested the impact of motivational interviewing ( MI ) delivered by primary care providers on pediatric obesity .
OBJECTIVE	This study tested the efficacy of MI delivered by providers and registered dietitians ( RDs ) to parents of overweight children aged 2 through 8 .
METHODS	Forty-two practices from the Pediatric Research in Office Settings Network of the American Academy of Pediatrics were randomly assigned to 1 of 3 groups .
METHODS	Group 1 ( usual care ) measured BMI percentile at baseline and 1 - and 2-year follow-up .
METHODS	Group 2 ( provider only ) delivered 4 MI counseling sessions to parents of the index child over 2 years .
METHODS	Group 3 ( provider + RD ) delivered 4 provider MI sessions plus 6 MI sessions from a RD. .
METHODS	The primary outcome was child BMI percentile at 2-year follow up .
RESULTS	At 2-year follow-up , the adjusted BMI percentile was 90.3 , 88.1 , and 87.1 for groups 1 , 2 , and 3 , respectively .
RESULTS	The group 3 mean was significantly ( P = .02 ) lower than group 1 .
RESULTS	Mean changes from baseline in BMI percentile were 1.8 , 3.8 , and 4.9 across groups 1 , 2 , and 3 .
CONCLUSIONS	MI delivered by providers and RDs ( group 3 ) resulted in statistically significant reductions in BMI percentile .
CONCLUSIONS	Research is needed to determine the clinical significance and persistence of the BMI effects observed .
CONCLUSIONS	How the intervention can be brought to scale ( in particular , how to train physicians to use MI effectively and how best to train RDs and integrate them into primary care settings ) also merits future research .

###24507941
BACKGROUND	Antithrombin ( AT ) concentrations are reduced after cardiac surgery with cardiopulmonary bypass compared with the preoperative levels .
BACKGROUND	Low postoperative AT is associated with worse short - and mid-term clinical outcomes .
BACKGROUND	The aim of the study is to evaluate the effects of AT administration on activation of the coagulation and fibrinolytic systems , platelet function , and the inflammatory response in patients with low postoperative AT levels .
METHODS	Sixty patients with postoperative AT levels of less than 65 % were randomly assigned to receive purified AT ( 5000 IU in three administrations ) or placebo in the postoperative intensive care unit .
METHODS	Thirty patients with postoperative AT levels greater than 65 % were observed as controls .
METHODS	Interleukin 6 ( a marker of inflammation ) , prothrombin fragment 1-2 ( a marker of thrombin generation ) , plasmin-antiplasmin complex ( a marker of fibrinolysis ) , and platelet factor 4 ( a marker of platelet activation ) were measured at six different times .
RESULTS	Compared with the no AT group and control patients , patients receiving AT showed significantly higher AT values until 48 hours after the last administration .
RESULTS	Analysis of variance for repeated measures showed a significant effect of study treatment in reducing prothrombin fragment 1-2 ( p = 0.009 ; interaction with time sample , p = 0.006 ) and plasmin-antiplasmin complex ( p < 0.001 ; interaction with time sample , p < 0.001 ) values but not interleukin 6 ( p = 0.877 ; interaction with time sample , p = 0.521 ) and platelet factor 4 ( p = 0.913 ; interaction with time sample , p = 0.543 ) .
RESULTS	No difference in chest tube drainage , reopening for bleeding , and blood transfusion was observed .
CONCLUSIONS	Antithrombin administration in patients with low AT activity after surgery with cardiopulmonary bypass reduces postoperative thrombin generation and fibrinolysis with no effects on platelet activation and inflammatory response .

###24976083
OBJECTIVE	We evaluated patients at tertiary [ both percutaneous coronary intervention ( PCI ) and coronary artery bypass grafting ( CABG ) capable ] and primary hospitals in the EARLY-ACS trial .
BACKGROUND	Early invasive management is recommended for high-risk non-ST-segment elevation acute coronary syndromes .
METHODS	We evaluated outcomes in 9,204 patients presenting to : tertiary sites , primary sites with transfer to tertiary sites ( `` transferred '' ) and those who remained at primary sites ( `` non-transfer '' ) .
RESULTS	There were 348 tertiary ( n = 7,455 patients ) and 89 primary hospitals [ n = 1,749 patients ( 729 transferred ; 1,020 non-transfer ) ] .
RESULTS	Significant delays occurred in time from symptom onset to angiography ( 49 hr ) , PCI ( 53h ) , and CABG ( 178 hr ) for transferred patients ( P < 0.001 ) .
RESULTS	Non-transfer patients had less 30-day death/myocardial infarction [ 9.4 % vs. 11.7 % ( tertiary ) ; adjusted odds ratio ( OR ) : 0.78 ( 0.62-0 .97 ) , P = 0.026 ] ; transferred ( 14.0 % ) and tertiary patients were similar [ adjusted OR : 1.23 ( 0.98-1 .53 ) , P = 0.074 ] .
RESULTS	Non-transfer patients had lower 1-year mortality [ 4.3 % vs. 6.3 % ( tertiary ) ; adjusted hazard ratio ( HR ) : 0.64 ( 0.47-0 .87 ) , P = 0.005 ] : there was no difference between transferred and tertiary patients [ 5.2 % vs. 6.3 % ; adjusted HR : 0.80 ( 0.58-1 .12 ) , P = 0.202 ] .
RESULTS	Despite similar rates of catheterization , GUSTO severe/moderate bleeding within 120 hr was less in non-transfer [ 3.1 % vs. 6.7 % ( tertiary ) ; adjusted OR : 0.47 ( 0.32-0 .68 ) , P < 0.001 ] , whereas transferred ( 6.1 % ) and tertiary patients were similar [ adjusted OR : 0.94 ( 0.68-1 .30 ) , P = 0.693 ] .
RESULTS	There was no difference in non-CABG bleeding .
CONCLUSIONS	Timely angiography and revascularization were often not achieved in transferred patients .
CONCLUSIONS	Non-transferred patients presenting to primary sites had the lowest event rates and the best long-term survival .

###25001475
OBJECTIVE	We hypothesized that a targeted temperature of 33 C as compared to that of 36 C would increase survival and reduce the severity of circulatory shock in patients with shock on admission after out-of-hospital cardiac arrest ( OHCA ) .
METHODS	The recently published Target Temperature Management trial ( TTM-trial ) randomized 939 OHCA patients with no difference in outcome between groups and no difference in mortality at the end of the trial in a predefined subgroup of patients with shock at admission .
METHODS	Shock was defined as a systolic blood pressure of < 90 mm Hg for > 30 min or the need of supportive measures to maintain a blood pressure 90 mmHg and/or clinical signs of end-organ hypoperfusion .
METHODS	In this post hoc analysis reported here , we further analyzed the 139 patients with shock at admission ; all had been randomized to receive intervention at 33 C ( TTM33 ; n = 71 ) or 36 C ( TTM36 ; n = 68 ) .
METHODS	Primary outcome was 180-day mortality .
METHODS	Secondary outcomes were intensive care unit ( ICU ) and 30-day mortality , severity of circulatory shock assessed by mean arterial pressure , serum lactate , fluid balance and the extended Sequential Organ Failure assessment ( SOFA ) score .
RESULTS	There was no significance difference between targeted temperature management at 33 C or 36 C on 180-day mortality [ log-rank test , p = 0.17 , hazard ratio 1.33 , 95 % confidence interval ( CI ) 0.88-1 .98 ] or ICU mortality ( 61 vs. 44 % , p = 0.06 ; relative risk 1.37 , 95 % CI 0.99-1 .91 ) .
RESULTS	Serum lactate and the extended cardiovascular SOFA score were higher in the TTM33 group ( p < 0.01 ) .
CONCLUSIONS	We found no benefit in survival or severity of circulatory shock with targeted temperature management at 33 C as compared to 36 C in patients with shock on admission after OHCA .

###25406902
BACKGROUND	Youths with a family history of alcohol and other drug use disorders ( FH + ) are at a greater risk of developing substance use disorders than their peers with no such family histories ( FH - ) , and this increased risk may be related to impaired maturation of forebrain circuitry .
BACKGROUND	FH + individuals have shown altered forebrain activity at rest and while performing cognitive tasks .
BACKGROUND	However , it is not fully understood how forebrain activity is altered in FH + individuals , and ultimately how these alterations may contribute to substance use disorder risk .
METHODS	In this study , we tested 72 FH + and 32 FH - youths performing a go/no-go task and examined activations in blocks with only go trials ( Go Only ) , blocks with 50 % go and 50 % no-go trials ( Go/NoGo ) , and a contrast of those 2 blocks .
RESULTS	FH + youths had significantly greater cerebral activations in both the Go and Go/NoGo blocks than FH - youths in regions including the posterior cingulate/precuneus , bilateral middle/superior temporal gyrus , and medial superior frontal gyrus with no significant group differences in the subtraction between Go Only and Go/NoGo blocks .
RESULTS	Additionally , FH + youths had moderately slower reaction times on go trials in the Go Only blocks .
CONCLUSIONS	Our findings suggest that global activation increase in FH + youths are modulated by FH density and are not specific to the inhibitory components of the task .
CONCLUSIONS	This pattern of increased activations in FH + youths may be at least partially due to impaired forebrain white matter development leading to greater activations/less efficient neural communication during task performance .

###25471989
BACKGROUND	Risk factors have been proposed for running injuries including ( a ) reduced muscular strength , ( b ) excessive joint movements and ( c ) excessive joint moments in the frontal and transverse planes .
BACKGROUND	To date , many running injury prevention programs have focused on a `` top down '' approach to strengthen the hip musculature in the attempt to reduce movements and moments at the hip , knee , and/or ankle joints .
BACKGROUND	However , running mechanics did not change when hip muscle strength increased .
BACKGROUND	It could be speculated that emphasis should be placed on increasing the strength of the ankle joint for a `` ground up '' approach .
BACKGROUND	Strengthening of the large and small muscles crossing the ankle joint is assumed to change the force distribution for these muscles and to increase the use of smaller muscles .
BACKGROUND	This would be associated with a reduction of joint and insertion forces , which could have a beneficial effect on injury prevention .
BACKGROUND	However , training of the ankle joint as an injury prevention strategy has not been studied .
BACKGROUND	Ankle strengthening techniques include isolated strengthening or movement-related strengthening such as functional balance training .
BACKGROUND	There is little knowledge about the efficacy of such training programs on strength alteration , gait or injury reduction .
METHODS	Novice runners will be randomly assigned to one of three groups : an isolated ankle strengthening group ( strength , n = 40 ) , a functional balance training group ( balance , n = 40 ) or an activity-matched control group ( control , n = 40 ) .
METHODS	Isokinetic strength will be measured using a Biodex System 3 dynamometer .
METHODS	Running kinematics and kinetics will be assessed using 3D motion analysis and a force platform .
METHODS	Postural control will be assessed by quantifying the magnitude and temporal structure of the center of pressure trace during single leg stance on a force platform .
METHODS	The change pre - and post-training in isokinetic strength , running mechanics , and postural control variables will be compared following the interventions .
METHODS	Injuries rates will be compared between groups over 6months .
CONCLUSIONS	Avoiding injury will allow individuals to enjoy the benefits of participating in aerobic activities and reduce the healthcare costs associated with running injuries .
BACKGROUND	Current Controlled Trial NCT01900262 .

###24694205
BACKGROUND	Vitamin B12 deficiency causes neurologic and psychiatric disease , especially in older adults .
BACKGROUND	Subacute combined degeneration is characterized by damage to the posterior and lateral spinal cord affecting the corticospinal tract .
OBJECTIVE	To test corticospinal tract projections using motor evoked potentials ( MEPs ) by transcranial magnetic stimulation ( TMS ) in asymptomatic older adults with low vitamin B12 ( B12 ) levels .
METHODS	Cross-sectional study of 53 healthy older adults ( > 70 years ) .
METHODS	MEPs were recorded in the abductor pollicis brevis and tibialis anterior muscles , at rest and during slight tonic contraction .
METHODS	Central motor conduction time ( CMCT ) was derived from the latency of MEPs and peripheral motor conduction time ( PMCT ) .
METHODS	Neurophysiological variables were analyzed statistically according to B12 status .
RESULTS	Median age was 74.33.6 years ( 58.5 % women ) .
RESULTS	Twenty-six out of the 53 subjects had low vitamin B12 levels ( B12 < 221pmol/l ) .
RESULTS	MEPs were recorded for all subjects in upper and lower extremities .
RESULTS	There were no significant differences in either latency or amplitude of MEPs and CMCT between low and normal B12 groups .
RESULTS	There was a significant PMCT delay in the lower extremities in the low B12 group ( p = 0.014 ) .
CONCLUSIONS	No subclinical abnormality of the corticospinal tract is detected in asymptomatic B12-deficient older adults .
CONCLUSIONS	The peripheral nervous system appears to be more vulnerable to damage attributable to this vitamin deficit .
CONCLUSIONS	The neurophysiological evaluation of asymptomatic older adults with lower B12 levels should be focused mainly in peripheral nervous system evaluation .

###24576512
BACKGROUND	Uncontrolled hypertension ( HTN ) is a significant public health problem among blacks in the United States .
BACKGROUND	Despite the proven efficacy of therapeutic lifestyle change ( TLC ) on blood pressure ( BP ) reduction in clinical trials , few studies have examined their effectiveness in church-based settings-an influential institution for health promotion in black communities .
METHODS	Using a cluster-randomized , 2-arm trial design , this study evaluates the effectiveness of a faith-based TLC intervention vs health education ( HE ) control on BP reduction among hypertensive black adults .
METHODS	The intervention is delivered by trained lay health advisors through group TLC sessions plus motivational interviewing in 32 black churches .
METHODS	Participants in the intervention group receive 11 weekly TLC sessions targeting weight loss , increasing physical activity , fruit , vegetable and low-fat dairy intake , and decreasing fat and sodium intake , plus 3 monthly individual motivational interviewing sessions .
METHODS	Participants in the control group attend 11 weekly classes on HTN and other health topics delivered by health care experts .
METHODS	The primary outcome is change in BP from baseline to 6 months .
METHODS	Secondary outcomes include level of physical activity , percent change in weight , and fruit and vegetable consumption at 6 months , and BP control at 9 months .
CONCLUSIONS	If successful , this trial will provide an alternative and culturally appropriate model for HTN control through evidence-based lifestyle modification delivered in churches by lay health advisors .

###24807407
BACKGROUND	The classification of clinical severity of Ebstein anomaly still remains a challenge .
BACKGROUND	The aim of this study was to focus on the interaction of the pathologically altered right heart with the anatomically-supposedly-normal left heart and to derive from cardiac magnetic resonance ( CMR ) a simple imaging measure for the clinical severity of Ebstein anomaly .
RESULTS	Twenty-five patients at a mean age of 2614 years with unrepaired Ebstein anomaly were examined in a prospective study .
RESULTS	Disease severity was classified using CMR volumes and functional measurements in comparison with heart failure markers from clinical data , ECG , laboratory and cardiopulmonary exercise testing , and echocardiography .
RESULTS	All examinations were completed within 24 hours .
RESULTS	A total right/left-volume index was defined from end-diastolic volume measurements in CMR : total right/left-volume index = ( RA + aRV + fRV ) / ( LA+LV ) .
RESULTS	Mean total right/left-volume index was 2.61.7 ( normal values : 1.10.1 ) .
RESULTS	This new total right/left-volume index correlated with almost all clinically used biomarkers of heart failure : brain natriuretic peptide ( r = 0.691 ; P = 0.0003 ) , QRS ( r = 0.432 ; P = 0.039 ) , peak oxygen consumption/kg ( r = -0.479 ; P = 0.024 ) , ventilatory response to carbon dioxide production at anaerobic threshold ( r = 0.426 ; P = 0.048 ) , the severity of tricuspid regurgitation ( r = 0.692 ; P = 0.009 ) , tricuspid valve offset ( r = 0.583 ; P = 0.004 ) , and tricuspid annular plane systolic excursion ( r = 0.554 ; P = 0.006 ) .
RESULTS	Previously described severity indices ( [ RA + aRV ] / [ fRV + LA+LV ] ) and fRV/LV end-diastolic volume corresponded only to some parameters .
CONCLUSIONS	In patients with Ebstein anomaly , the easily acquired index of right-sided to left-sided heart volumes from CMR correlated well with established heart failure markers .
CONCLUSIONS	Our data suggest that the total right/left-volume index should be used as a new and simplified CMR measure , allowing more accurate assessment of disease severity than previously described scoring systems .

###24947717
OBJECTIVE	This study sought to investigate the association of beta-blocker therapy at discharge with clinical outcomes in patients with ST-segment elevation myocardial infarction ( STEMI ) after primary percutaneous coronary intervention ( PCI ) .
BACKGROUND	Limited data are available on the efficacy of beta-blocker therapy for secondary prevention in STEMI patients .
METHODS	Between November 1 , 2005 and September 30 , 2010 , 20,344 patients were enrolled in nationwide , prospective , multicenter registries .
METHODS	Among these , we studied STEMI patients undergoing primary PCI who were discharged alive ( n = 8,510 ) .
METHODS	We classified patients into the beta-blocker group ( n = 6,873 ) and no-beta-blocker group ( n = 1,637 ) according to the use of beta-blockers at discharge .
METHODS	Propensity-score matching analysis was also performed in 1,325 patient triplets .
METHODS	The primary outcome was all-cause death .
RESULTS	The median follow-up duration was 367 days ( interquartile range : 157 to 440 days ) .
RESULTS	All-cause death occurred in 146 patients ( 2.1 % ) of the beta-blocker group versus 59 patients ( 3.6 % ) of the no-beta-blocker group ( p < 0.001 ) .
RESULTS	After 2:1 propensity-score matching , beta-blocker therapy was associated with a lower incidence of all-cause death ( 2.8 % vs. 4.1 % , adjusted hazard ratio : 0.46 , 95 % confidence interval : 0.27 to 0.78 , p = 0.004 ) .
RESULTS	The association with better outcome of beta-blocker therapy in terms of all-cause death was consistent across various subgroups , including patients with relatively low-risk profiles such as ejection fraction > 40 % or single-vessel disease .
CONCLUSIONS	Beta-blocker therapy at discharge was associated with improved survival in STEMI patients treated with primary PCI .
CONCLUSIONS	Our results support the current American College of Cardiology/American Heart Association guidelines , which recommend long-term beta-blocker therapy in all patients with STEMI regardless of reperfusion therapy or risk profile .

###24281275
OBJECTIVE	Local anesthetic wound infiltration is widely used as an effective adjunct during multimodal postoperative pain management .
OBJECTIVE	The aim of this study was to evaluate the effectiveness of continuous wound infusion of ropivacaine in postoperative pain relief , opioid sparing , incidence of nausea and vomiting , and bowel and liver function improvement in patients undergoing open hepatectomy .
METHODS	Forty patients undergoing open hepatectomy were enrolled in this prospective , randomized , double-blinded , placebo-controlled trial .
METHODS	Patients were divided into 2 groups : the 0.9 % saline continuous infusion group ( the control group ; n = 20 ) and the ropivacaine continuous infusion group ( the Ropi group ; n = 20 ) .
METHODS	Outcomes measured postoperatively were pain score at rest and on movement , sufentanil consumption , incidence of nausea and vomiting , and sedation score across 48 postoperative hours .
METHODS	Time to bowel recovery , liver function change , mean length of hospitalization , patient satisfaction , and other data after 48 postoperative hours were collected until hospital discharge .
RESULTS	Pain scores at rest were lower for the ropivacaine group and reached significance after 8 and 16 hours ( P < 0.01 ) .
RESULTS	Sufentanil consumption ( 41.5021.80 vs. 89.7035.22 g ; P < 0.01 ) after 48 hours , time to bowel recovery ( 1.800.70 vs. 3.151.04 d ; P < 0.01 ) , incidence of nausea and vomiting ( 1.750.72 vs. 2.400.68 ; P < 0.05 ) , and mean length of hospitalization ( 5.62.44 vs. 7.352.85 d ; P < 0.01 ) were significantly reduced , and the sedation score and liver function change were also comparable between the 2 groups .
RESULTS	There was no difference with respect to pain scores on movement , nor with respect to patient satisfaction .
CONCLUSIONS	Surgical wound infusion with ropivacaine after hepatectomy can improve pain relief at rest and accelerate recovery and discharge .

###24911353
OBJECTIVE	Tuberculosis ( TB ) is highly prevalent among HIV-infected people , including those receiving combination antiretroviral therapy ( cART ) , necessitating a well tolerated and efficacious TB vaccine for these populations .
OBJECTIVE	We evaluated the safety and immunogenicity of the candidate TB vaccine M72/AS01 in adults with well controlled HIV infection on cART .
METHODS	A randomized , observer-blind , controlled trial ( NCT00707967 ) .
METHODS	HIV-infected adults on cART in Switzerland were randomized 3:1:1 to receive two doses , 1 month apart , of M72/AS01 , AS01 or 0.9 % physiological saline ( N = 22 , N = 8 and N = 7 , respectively ) and were followed up to 6 months postdose 2 ( D210 ) .
METHODS	Individuals with CD4 cell counts below 200 cells/l were excluded .
METHODS	Adverse events ( AEs ) including HIV-specific and laboratory safety parameters were recorded .
METHODS	Cell-mediated ( ICS ) and humoral ( ELISA ) responses were evaluated before vaccination , 1 month after each dose ( D30 , D60 ) and D210 .
RESULTS	Thirty-seven individuals [ interquartile range ( IQR ) CD4 cell counts at screening : 438-872 cells/l ; undetectable HIV-1 viremia ] were enrolled ; 73 % of individuals reported previous BCG vaccination , 97.3 % tested negative for the QuantiFERON-TB assay .
RESULTS	For M72/AS01 recipients , no vaccine-related serious AEs or cART-regimen adjustments were recorded , and there were no clinically relevant effects on laboratory safety parameters , HIV-1 viral loads or CD4 cell counts .
RESULTS	M72/AS01 was immunogenic , inducing persistent and polyfunctional M72-specific CD4 T-cell responses [ medians 0.70 % ( IQR 0.37-1 .07 ) at D60 ] and 0.42 % ( 0.24-0 .61 ) at D210 , predominantly CD40LIL-2TNF - , CD40LIL-2 and CD40LIL-2TNF-IFN - ] .
RESULTS	All M72/AS01 vaccines were seropositive for anti-M72 IgG after second vaccination until study end .
CONCLUSIONS	M72/AS01 was clinically well tolerated and immunogenic in this population , supporting further clinical evaluation in HIV-infected individuals in TB-endemic settings .

###25318787
OBJECTIVE	The aim of this study was to investigate whether remedial hydration ( RH ) reduces the incidence of contrast-induced nephropathy ( CIN ) and short-term adverse events in ST-elevation myocardial infarction ( STEMI ) patients undergoing primary percutaneous coronary intervention ( PCI ) .
METHODS	A total of 216 consecutive STEMI patients were prospectively and randomly assigned into two groups : 108 patients in the RH group and 108 patients in the no RH ( control ) group .
METHODS	The serum creatinine ( SCr ) and creatinine clearance ( CCr ) levels were measured on admission and at 24 , 48 and 72 hours after primary PCI .
METHODS	The rates of CIN and short-term adverse events were analyzed for each group .
METHODS	After surgery , the patients were categorized into four groups according to the Mehran risk score : low ( 5 , n = 98 ) , moderate ( 6-10 , n = 56 ) , high ( 11-15 , n = 40 ) or very high ( 16 , n = 22 ) .
RESULTS	The incidence of CIN in the RH group was lower than that observed in the control group ( 22/108 ; 20.4 % vs. 38/108 ; 35.2 % , p < 0.05 ) .
RESULTS	The subgroup analysis showed that the rate of CIN was lower in the moderate ( 6/29 ; 20.7 % vs. 13/30 ; 43.3 % , p < 0.10 ) and significantly lower in both the high ( 5/21 ; 23.8 % vs. 10/18 ; 55.6 % , p < 0.05 ) and very high score groups ( 3/12 ; 25.0 % vs. 8/12 ; 66.7 % , p < 0.05 ) among the RH patients compared to the controls .
RESULTS	At 24 , 48 and 72 hours after PCI , the patients in the RH group exhibited lower SCr levels and higher CCr levels than the patients in the control group ( both p < 0.05 ) .
RESULTS	A lower incidence of in-hospital clinical events was also observed in the RH group .
CONCLUSIONS	Remedial hydration decreases the occurrence of CIN and improves the short-term prognosis of STEMI patients undergoing primary PCI .

###24396280
BACKGROUND	An increased production of oxidizing species related to reactive oral diseases , such as chronic apical periodontitis , could have systemic implications such as an increase in cardiovascular morbidity .
BACKGROUND	Based on this consideration , we conducted a prospective study to assess whether subjects affected by chronic periodontitis presented with higher values of oxidative stress than reference values before endodontic treatment , and whether endodontic treatment can reduce the oxidative imbalance and bring it back to normal in these subjects .
METHODS	The authors recruited 2 groups of patients from private studies and dental clinics : these patients were recruited randomly .
METHODS	The oxidative balance in both patients with chronic apical periodontitis ( CAP ) and healthy control patients was determined by measuring the oxidant status , using an identification of the reactive oxygen metabolites ( d-ROMs ) test , while the antioxidant status in these patients was determined using a biological antioxidant potential ( BAP ) test .
METHODS	Both these tests were carried on plasma samples taken from enrolled patients .
METHODS	Values were measured both before the endodontic treatment of the patients with chronic apical periodontitis , and 30 and 90 days after treatment , and compared to those obtained from healthy control patients .
RESULTS	It was found that , on recruitment , the patients with chronic apical periodontitis exhibited significantly higher levels of oxidative stress than control patients , as determined by the d-ROMs and BAP tests .
RESULTS	Furthermore , the d-ROMs test values were shown to decrease and the BAP test values to increase over time in patients with chronic apical periodontitis following endodontic therapy .
RESULTS	As the levels of oxidative stress in these patients tended to reduce and return to normal by 90 days following treatment .
CONCLUSIONS	This study has demonstrated a positive association between chronic apical periodontitis and oxidative stress .
CONCLUSIONS	Subjects affected by chronic apical periodontitis are exposed to a condition of oxidative stress , which is extremely dangerous to general health .
CONCLUSIONS	Moreover , one can infer from these findings that through proper endodontic therapy , a good oxidative balance can be restored , thereby avoiding the risk of contracting the abovementioned diseases .

###24731889
BACKGROUND	Placebo effect has been largely studied and debated in medicine .
BACKGROUND	Research focused mainly on children and adults but not on newborns .
BACKGROUND	In osteopathy , few studies documented this effect and no research has been conducted in newborns .
OBJECTIVE	To assess the presence of placebo effect in newborns using sham osteopathic manipulative treatment .
METHODS	Randomized control trial .
METHODS	Neonatal Intensive Care Unit in Italy .
METHODS	Two groups ( 103 patients each ) of preterm infants aged 29-36 weeks without medical complications received routine pediatric care and osteopathic sham therapy was administrated to the study group only for the entire period of hospitalization .
METHODS	Primary end point was the mean reduction of length of stay at discharge .
METHODS	Secondary objective was the change in daily weight gain .
RESULTS	206 newborns entered the study .
RESULTS	No difference between sham and control group was found for the primary outcome length of stay ( 30.020.3 ; 28.818.9 ; p = 0.70 ) .
RESULTS	Multivariate analysis showed no difference between study and control group on length of stay .
RESULTS	A negative association was found for gestational age ( -2.33 ; 95 % CI -3.81 to -0.85 ; p = 0.002 ) , birth weight ( -0.01 ; 95 % CI -0.02 to -0.01 ; p < 0.001 ) and milk volume at study enrollment ( -0.02 ; 95 % CI -0.05 to -0.01 ; p = 0.01 ) .
CONCLUSIONS	To the best of our knowledge , this study is the first in the field showing no placebo effect on newborns .
CONCLUSIONS	Further discussions are opened concerning the age when placebo effect starts .

###25880933
BACKGROUND	Clostridium difficile infection ( CDI ) is a leading cause of diarrhoea in health care settings with symptoms ranging from mild and self-limiting to life threatening .
BACKGROUND	SMT19969 is a novel , non-absorbable antibiotic currently under development for the treatment of CDI .
BACKGROUND	Here we report the results from a Phase I study .
METHODS	A double-blind , randomized , placebo-controlled study assessing safety and tolerability of single and multiple oral doses of SMT19969 in healthy volunteers .
METHODS	Pharmacokinetic assessments included blood and faecal sampling .
METHODS	The effect of food on systemic exposure and analysis of the gut microbiota were also included .
RESULTS	Fifty-six healthy male subjects were enrolled .
RESULTS	Following single oral doses of up to 2,000 mg in the fasted state , plasma concentrations of SMT19969 were generally below the lower limit of quantification .
RESULTS	In the fed state levels ranged from 0.102 to 0.296 ng/mL after single dosing and after repeat dosing at Day 10 from 0.105 to 0.305 ng/mL .
RESULTS	Following single and multiple oral doses of SMT19969 , mean daily faecal concentrations increased with increasing dose level and were significantly above the typical MIC range for C. difficile ( 0.06-0 .5 g/mL ) .
RESULTS	At 200 mg BID , mean ( SD ) faecal concentrations of 1,466 ( 547 ) g/g and 1,364 ( 446 ) g/g were determined on days 5 and 10 of dosing respectively .
RESULTS	No notable metabolites were detected in faeces .
RESULTS	Overall , all doses of SMT19969 were well tolerated both as single oral doses or BID oral doses for 10 days .
RESULTS	The majority ( 88 % ) of adverse events ( AEs ) were classified as gastrointestinal disorders and were mild in severity , resolving without treatment .
RESULTS	The gut microbiota was analysed in the multiple dose groups with minimal changes observed in the bacterial groups analysed except for total clostridia which were reduced to below the limit of detection by day 4 of dosing .
CONCLUSIONS	Oral administration of SMT19969 was considered safe and well tolerated and was associated with negligible plasma concentrations after single and multiple doses .
CONCLUSIONS	In addition , minimal disruption of normal gut microbiota was noted , confirming the highly selective spectrum of the compound .
CONCLUSIONS	These results support the further clinical development of SMT19969 as an oral therapy for CDI .
BACKGROUND	Current Controlled Trials .
BACKGROUND	ISRCTN10858225 .

###25231496
BACKGROUND	While overall survival for most common cancers in Australia is improving , the rural-urban differential has been widening , with significant excess deaths due to lung , colorectal , breast and prostate cancer in regional Australia .
BACKGROUND	Internationally a major focus on understanding variations in cancer outcomes has been later presentation to healthcare and later diagnosis .
BACKGROUND	Approaches to reducing time to diagnosis of symptomatic cancer include public symptom awareness campaigns and interventions in primary care to improve early cancer detection .
BACKGROUND	This paper reports the protocol of a factorial cluster-randomised trial of community and general practice ( GP ) level interventions to reduce the time to diagnosis of cancer in rural Western Australia ( WA ) .
METHODS	The community intervention is a symptom awareness campaign tailored for rural Australians delivered through a community engagement model .
METHODS	The GP intervention includes a resource card with symptom risk assessment charts and local referral pathways implemented through multiple academic detailing visits and case studies .
METHODS	Participants are eligible if recently diagnosed with breast , colorectal , lung or prostate cancer who reside in specific regions of rural WA with a planned sample size of 1350 .
METHODS	The primary outcome is the Total Diagnostic Interval , defined as the duration from first symptom ( or date of cancer screening test ) to cancer diagnosis .
METHODS	Secondary outcomes include cancer stage , healthcare utilisation , disease-free status , survival at 2 and 5years and cost-effectiveness .
BACKGROUND	Ethics approval has been granted by the University of Western Australia and from all relevant hospital recruitment sites in WA .
RESULTS	Results of this trial will be reported in peer-reviewed publications and in conference presentations .
BACKGROUND	Australian New Zealand Clinical Trials Registry ( ANZCTR ) .
BACKGROUND	ACTRN12610000872033 .

###26024687
BACKGROUND	This study aimed to evaluate whether incidental CT findings of emphysema , airway thickening and bronchiectasis , as seen on CT scans performed for other non-pulmonary clinical indications , are associated with future acute exacerbations of COPD resulting in hospitalisation or death .
METHODS	This multicentre prospective case-cohort study comprised 6406 subjects who underwent routine diagnostic chest CT for non-pulmonary indications .
METHODS	Using a case-cohort approach , we visually graded CT scans from cases and a random sample of 10 % of the baseline cohort ( n = 704 ) for emphysema severity ( range 0-20 ) , airway thickening ( range 0-5 ) and bronchiectasis ( range 0-5 ) .
METHODS	We used weighted Cox proportional hazards analysis to assess the independent association between CT findings and hospitalisation or death due to COPD exacerbation .
RESULTS	During a median follow-up of 4.4 years ( maximum 5.2 years ) , 338 COPD events were identified .
RESULTS	The risk of experiencing a future acute exacerbation of COPD resulting in hospitalisation or death was significantly increased in subjects with severe emphysema ( score 7 ) and severe airway thickening ( score 3 ) .
RESULTS	The respective HRs were 4.6 ( 95 % CI 3.0 to 7.1 ) and 5.9 ( 95 % CI 3.4 to 10.5 ) .
RESULTS	Severe bronchiectasis ( score 3 ) was not significantly associated with increased risk of adverse events ( HR 1.5 ; 95 % CI 0.9 to 2.5 ) .
CONCLUSIONS	Morphological correlates of COPD such as emphysema and airway thickening detected on CT scans obtained for other non-pulmonary indications are strong independent predictors of subsequent development of acute exacerbations of COPD resulting in hospitalisation or death .

###24851690
OBJECTIVE	To explore the feasibility of making a preoperative diagnosis of lung adenocarcinoma shown as ground-glass nodule ( GGN ) on computed tomography ( CT ) .
METHODS	A total of 143 GGN lesions proved pathologically were divided randomly into A and B groups .
METHODS	Then each group was further divided pathologically into preinvasive lesion , minimal invasive adenocarcinoma ( MIA ) and invasive adenocarcinoma ( IAC ) subgroups .
METHODS	Group A ( n = 101 ) , size of lesion , proportion of ground glass opacity ( GGO ) composition of lesion , long diameter , longest diameter and size of solid component in lesion were measured on CT so as to establish the CT diagnostic standard of lung adenocarcinoma shown as GGN on CT. .
METHODS	Group B ( n = 42 ) was employed to evaluate the accuracy of the above CT diagnostic standard .
METHODS	SPSS 17.0 software was used for statistical analysis .
RESULTS	Significant statistic significance existed in all parameters among all groups ( P < 0.05 ) .
RESULTS	All parameters were correlated the pathologic type of lesion .
RESULTS	The differences were statistically significant ( P = 0.000 ) .
RESULTS	Through the receiver operating characteristic ( ROC ) curve , between groups of preinvasive lesion and MIA , each parameter had a medium diagnostic value of 0.70-0 .90 ; between groups of MIA and IAC , size of lesion and long diameter of solid component in lesion had a medium diagnostic value of 0.70-0 .90 , longest diameter of solid component , size of solid component in lesion and proportion of GGO composition of lesion had a high diagnostic value with an AUC of > 0.90 .
RESULTS	The CT diagnostic standard , derived from group A , was used to analyze the pathologic type of group B. And t no significant statistic significance existed between CT preoperative diagnosis and operative pathologic diagnosis ( P > 0.05 ) .
RESULTS	The correct diagnosis rates of size of lesion , proportion of GGO composition of lesion , long diameter , longest diameter and size of solid component in lesion were 71.43 % , 76.19 % , 90.05 % , 90.05 % and 88.10 % respectively .
CONCLUSIONS	Based upon size of lesion , proportion of GGO composition of lesion , long diameter , longest diameter and size of solid component in lesion , preoperative CT examination may be used to determine the pathological types of lung adenocarcinoma shown as GGN .

###25883103
OBJECTIVE	Tonsillectomy surgery is associated with severe postoperative pain that usually requires analgesics including opioids .
OBJECTIVE	Pain control is still a big problem after tonsillectomy surgery .
OBJECTIVE	We aimed to evaluate the efficacy of preemptive analgesia using montelukast for pediatric post-tonsillectomy pain management .
OBJECTIVE	This is the first-time use of montelukast in post-tonsillectomy pain .
METHODS	Double-blind , controlled-randomized study .
METHODS	University teaching and research hospital .
METHODS	A total of 60 children , aged 5 to 15 years , American Society of Anesthesiologist class I-II , scheduled for elective tonsillectomy were enrolled in this clinical trial study .
METHODS	The patients were randomized into 2 groups : the montelukast group ( group M , n = 30 ) and control group ( group C , n = 30 ) .
METHODS	Group M recieved an oral montelukast tablet and group C recieved placebo at 2400pm on the morning before surgery .
METHODS	Post-tonsillectomy pain was evaluated with the Wong-Baker FACES Scale during the 24 hours after surgery .
METHODS	Patients ' intraoperative hemodynamic parameters and intraoperative and postoperative complications were recorded .
RESULTS	There were statistically significant differences between group C and group M for Wong-Baker FACES pain rating scale scores ( P < .05 ) .
RESULTS	In the 24 hours after surgery , the total number of patients using rescue analgesics was higher in group C than in group M , and the difference was statistically significant ( P < .001 ) .
RESULTS	There was no significant difference in demographic parameters ( P > .05 ) .
RESULTS	There were no significant differences in postoperative nausea and vomiting , otalgia , trismus , fever , or halitosis between the groups ( P > .05 ) .
CONCLUSIONS	Preemptive montelukast can be used safely to reduce the serious pain caused by tonsillectomy in children .

###24318863
OBJECTIVE	Metastatic colon cancer patients are treated with the chemotherapy regimens , FOLFOX and FOLFIRI , in either order .
OBJECTIVE	So far , we can not predict the response of chemotherapeutic agent , so it is necessary to find which regimen is adequate before starting chemotherapy .
METHODS	Enrolled patients are randomized into either conventional treatment or planned treatment preceded by pretreatment genetic analysis .
METHODS	Blood samples of patients in planned treatment group ( N = 53 ) were analyzed for the genetic polymorphism before selection of chemotherapeutic agents .
METHODS	Target genes were XPD-751 , GSTP-1-105 , XRCC1-399 for oxaliplatin , UGT1A1 for irinotecan .
METHODS	The response was measured by computed tomographic scan after completion of three cycles of chemotherapy .
RESULTS	Overall response rate was significantly higher in planned group ( 67.9 % vs. 46.3 % , P = 0.020 ) .
RESULTS	In FOLFOX group , response rate was significantly improved in the planned patients ( 77.1 % vs. 50 % , P = 0.018 ) .
RESULTS	In FOLFIRI group , the difference did n't reach statistical significance ( 50 % vs. 42.5 % , P = 0.776 ) .
CONCLUSIONS	We found significantly improved response rates in the chemotherapy of metastatic colon cancer by pretreatment genetic analysis , especially in FOLFOX group .

###25872502
BACKGROUND	Cardiac arrest causes ischaemic brain injury .
BACKGROUND	Arterial carbon dioxide tension ( PaCO2 ) is a major determinant of cerebral blood flow .
BACKGROUND	Thus , mild hypercapnia in the 24 h following cardiac arrest may increase cerebral blood flow and attenuate such injury .
BACKGROUND	We describe the Carbon Control and Cardiac Arrest ( CCC ) trial .
METHODS	The CCC trial is a pilot multicentre feasibility , safety and biological efficacy randomized controlled trial recruiting adult cardiac arrest patients admitted to the intensive care unit after return of spontaneous circulation .
METHODS	At admission , using concealed allocation , participants are randomized to 24 h of either normocapnia ( PaCO2 35 to 45 mmHg ) or mild hypercapnia ( PaCO2 50 to 55 mmHg ) .
METHODS	Key feasibility outcomes are recruitment rate and protocol compliance rate .
METHODS	The primary biological efficacy and biological safety measures are the between-groups difference in serum neuron-specific enolase and S100b protein levels at 24 h , 48 h and 72 h. Secondary outcome measure include adverse events , in-hospital mortality , and neurological assessment at 6 months .
CONCLUSIONS	The trial commenced in December 2012 and , when completed , will provide clinical evidence as to whether targeting mild hypercapnia for 24 h following intensive care unit admission for cardiac arrest patients is feasible and safe and whether it results in decreased concentrations of neurological injury biomarkers compared with normocapnia .
CONCLUSIONS	Trial results will also be used to determine whether a phase IIb study powered for survival at 90 days is feasible and justified .
BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12612000690853 .

###24226487
BACKGROUND	For decades thiopental has been considered as the hypnotic drug of choice for intracranial surgery .
BACKGROUND	However , total intravenous anesthesia performed with thiopental is associated with delayed recovery , whereas early post-operative neurological evaluation is critical .
BACKGROUND	For this reason , target controlled infusion ( TCI ) of propofol is increasingly used for maintenance of anesthesia .
BACKGROUND	However , a thiopental TCI has never been assessed for this purpose .
BACKGROUND	We tested the hypothesis that a thiopental TCI provides an acceptable way to achieve early recovery compared to a propofol TCI during supratentorial surgery .
METHODS	Eighty patients undergoing elective craniotomy for a supratentorial tumor were randomized to receive either a propofol TCI ( group P ) or a thiopental TCI ( group T ) .
METHODS	Both groups received a sufentanil TCI and the bispectral index was monitored .
METHODS	The primary end-point was time to tracheal extubation .
METHODS	Secondary end-points were per - and post-operative hemodynamics as well as respiratory and recovery parameters .
METHODS	Assessment of study end-points was performed by an intensive care specialist blinded ( like the patient ) to the received hypnotic .
RESULTS	Time to extubation was significantly ( P < 0.0001 ) shorter in group P ( median 149 minutes ; interquartile range 72-250 minutes ) than in group T ( median 453 minutes ; interquartile range 286-813 minutes ) .
RESULTS	Similarly , the recovery parameters were significantly better in group P than in group T.
RESULTS	There was no difference between groups in terms of patient characteristics and hemodynamic parameters .
CONCLUSIONS	Even with TCI and bispectral index monitoring , thiopental is associated with an inappropriate delayed recovery from supratentorial surgery compared to propofol TCI .

###25539560
OBJECTIVE	To investigate the effects of conservative therapy applied before arthroscopic subacromial decompression on the clinical outcome in patients with stage 2 shoulder impingement syndrome .
METHODS	Sixty-eight patients having stage 2 shoulder impingement syndrome and treated with arthroscopic subacromial decompression were included in the study .
METHODS	We divided these patients into 2 groups , whereby 32 ( 47 % ) patients received conservative therapy before arthroscopic subacromial decompression and 36 ( 53 % ) patients did not receive conservative therapy .
METHODS	We compared both groups in terms of the the Constant , UCLA , and VAS scores for shoulder pain before and after arthroscopic subacromial decompression .
RESULTS	Constant , UCLA , and VAS scores were statistically significantly improved in both groups after arthroscopic subacromial decompression ( P < 0.001 ) .
RESULTS	Constant , UCLA , and VAS scores before arthroscopic subacromial decompression were statistically better in Group 1 than in Group 2 ( P < 0.001 ) .
RESULTS	No statistically significant difference was found between the groups in terms of Constant , UCLA , and VAS scores after arthroscopic subacromial decompression ( P > 0.05 ) .
CONCLUSIONS	Conservative therapy applied in patients with stage 2 shoulder impingement syndrome before arthroscopic subacromial decompression does not have a positive contribution on the clinical outcome after arthroscopic subacromial decompression .

###24401051
BACKGROUND	Obstructive sleep apnea is associated with considerable health risks .
BACKGROUND	Although continuous positive airway pressure ( CPAP ) can mitigate these risks , effectiveness can be reduced by inadequate adherence to treatment .
BACKGROUND	We evaluated the clinical safety and effectiveness of upper-airway stimulation at 12 months for the treatment of moderate-to-severe obstructive sleep apnea .
METHODS	Using a multicenter , prospective , single-group , cohort design , we surgically implanted an upper-airway stimulation device in patients with obstructive sleep apnea who had difficulty either accepting or adhering to CPAP therapy .
METHODS	The primary outcome measures were the apnea-hypopnea index ( AHI ; the number of apnea or hypopnea events per hour , with a score of 15 indicating moderate-to-severe apnea ) and the oxygen desaturation index ( ODI ; the number of times per hour of sleep that the blood oxygen level drops by 4 percentage points from baseline ) .
METHODS	Secondary outcome measures were the Epworth Sleepiness Scale , the Functional Outcomes of Sleep Questionnaire ( FOSQ ) , and the percentage of sleep time with the oxygen saturation less than 90 % .
METHODS	Consecutive participants with a response were included in a randomized , controlled therapy-withdrawal trial .
RESULTS	The study included 126 participants ; 83 % were men .
RESULTS	The mean age was 54.5 years , and the mean body-mass index ( the weight in kilograms divided by the square of the height in meters ) was 28.4 .
RESULTS	The median AHI score at 12 months decreased 68 % , from 29.3 events per hour to 9.0 events per hour ( P < 0.001 ) ; the ODI score decreased 70 % , from 25.4 events per hour to 7.4 events per hour ( P < 0.001 ) .
RESULTS	Secondary outcome measures showed a reduction in the effects of sleep apnea and improved quality of life .
RESULTS	In the randomized phase , the mean AHI score did not differ significantly from the 12-month score in the nonrandomized phase among the 23 participants in the therapy-maintenance group ( 8.9 and 7.2 events per hour , respectively ) ; the AHI score was significantly higher ( indicating more severe apnea ) among the 23 participants in the therapy-withdrawal group ( 25.8 vs. 7.6 events per hour , P < 0.001 ) .
RESULTS	The ODI results followed a similar pattern .
RESULTS	The rate of procedure-related serious adverse events was less than 2 % .
CONCLUSIONS	In this uncontrolled cohort study , upper-airway stimulation led to significant improvements in objective and subjective measurements of the severity of obstructive sleep apnea .
CONCLUSIONS	( Funded by Inspire Medical Systems ; STAR ClinicalTrials.gov number , NCT01161420 . )

###26126563
OBJECTIVE	To identify facilitators and barriers to clinical trial implementation in Aboriginal health services .
METHODS	Indepth interview study with thematic analysis .
METHODS	Six Aboriginal community-controlled health services and one government-run service involved in the Kanyini Guidelines Adherence with the Polypill ( KGAP ) study , a pragmatic randomised controlled trial that aimed to improve adherence to indicated drug treatments for people at high risk of cardiovascular disease .
METHODS	32 health care providers and 21 Aboriginal and Torres Strait Islander patients .
RESULTS	A fundamental enabler was that participants considered the research to be governed and endorsed by the local health service .
RESULTS	That the research was perceived to address a health priority for communities was also highly motivating for both providers and patients .
RESULTS	Enlisting the support of Aboriginal and Torres Strait Islander staff champions who were visible to the community as the main source of information about the trial was particularly important .
RESULTS	The major implementation barrier for staff was balancing their service delivery roles with adherence to often highly demanding trial-related procedures .
RESULTS	This was partially alleviated by the research team 's provision of onsite support and attempts to make trial processes more streamlined .
RESULTS	Although more intensive support was highly desired , there were usually insufficient resources to provide this .
CONCLUSIONS	Despite strong community and health service support , major investments in time and resources are needed to ensure successful implementation and minimal disruption to already overstretched , routine services .
CONCLUSIONS	Trial budgets will necessarily be inflated as a result .
CONCLUSIONS	Funding agencies need to consider these additional resource demands when supporting trials of a similar nature .

###24693629
OBJECTIVE	To compare the effect of incomplete caries removal ( ICR ) and indirect pulp capping ( IPC ) with calcium hydroxide ( CH ) or an inert material ( wax ) on color , consistency and contamination of the remaining dentin of primary molars .
METHODS	This double-blind , parallel-design , randomized controlled trial included 30 children presenting one primary molar with deep caries lesion .
METHODS	Children were randomly assigned after ICR to receive IPC with CH or wax .
METHODS	All teeth were then restored with resin composite .
METHODS	Baseline dentin color and consistency were evaluated after ICR , and dentin samples were collected for contamination analyses using scanning electron microscopy .
METHODS	After 3 months , restorations were removed and the three parameters were re-evaluated .
METHODS	In both groups , dentin became significantly darker after 3 months .
RESULTS	No cases of yellow dentin were observed after 3 months with CH compared to 33.3 % of the wax cases ( P < 0.05 ) .
RESULTS	A statistically significant difference over time was observed only for CH regarding consistency .
RESULTS	CH stimulated a dentin hardening process in a statistically higher number of cases than wax ( 86.7 % vs. 33.3 % ; P = 0.008 ) .
RESULTS	Contamination changed significantly over time in CH and wax without significant difference between groups .
RESULTS	It was concluded that CH and wax arrested the carious process of the remaining carious dentin after indirect pulp capping , but CH showed superior dentin color and consistency after 3 months .

###24996519
BACKGROUND	In literature there is a general consensus that the use of the mirror improves proprioception .
BACKGROUND	During rehabilitation the mirror is an important instrument to improve stability .
BACKGROUND	In some sports , such as dancing , mirrors are widely used during training .
BACKGROUND	The purpose of this study is to evaluate the effectiveness of the use of a mirror on balance in young dancers .
BACKGROUND	Sixty-four young dancers ( ranging from 9-10 years ) were included in this study .
BACKGROUND	Thirty-two attending lessons with a mirror ( mirror - group ) were compared to 32 young dancers that attended the same lessons without a mirror ( non-mirror group ) .
BACKGROUND	Balance was evaluated by BESS ( Balance Error Scoring System ) , which consists of three stances ( double limb , single limb , and tandem ) on two surfaces ( firm and foam ) .
BACKGROUND	The errors were assessed at each stance and summed to create the two subtotal scores ( firm and foam surface ) and the final total score ( BESS ) .
BACKGROUND	The BESS was performed at recruitment ( T0 ) and after 6months of dance lessons ( T1 ) .
RESULTS	The repeated measures ANOVA analysis showed that for the BESS total score there is a difference due to the time ( F = 3.86 ; p < 0.05 ) .
RESULTS	No other differences due to the group or to the time of measurement were found ( p > 0.05 ) .
RESULTS	The analysis of the multiple regression model showed the influence of the values at T0 for every BESS items and the dominance of limb for stability on an unstable surface standing on one or two legs .
CONCLUSIONS	These preliminary results suggest that the use of a mirror in a ballet classroom does not improve balance acquisition of the dancer .
CONCLUSIONS	On the other hand , improvement found after 6months confirms that at the age of the dancers studied motor skills and balance can easily be trained and improved .

###25440306
OBJECTIVE	Long-term follow-up studies documenting maintenance of treatment effects are fewin adolescent anorexia nervosa ( AN ) .
OBJECTIVE	This exploratory study reports relapse from full remission and attainment of remission during a 4-year open follow-up period using a convenience sample of a subgroup of 65 % ( n = 79 ) from an original cohort of 121 participants who completed a randomized clinical trial comparing family-based therapy ( FBT ) and adolescent-focused individual therapy ( AFT ) .
METHODS	Follow-up assessments were completed up to 4years posttreatment ( average , 3.26 years ) .
METHODS	Available participants completed the Eating Disorder Examination as well as self-report measures of self-esteem and depression at 2 to 4 years posttreatment .
RESULTS	Two participants ( 6.1 % ) relapsed ( FBT : n = 1 , 4.5 % ; AFT : n = 1 , 9.1 % ) , on average 1.98 years ( SD = 0.14 years ) after remission was achieved at 1-year follow-up .
RESULTS	Ten new participants ( 22.7 % ) achieved remission ( FBT : n = 1 , 5.9 % ; AFT : n = 9 , 33.3 % ) .
RESULTS	Mean time to remission for this group was 2.01 years ( SD = 0.82 years ) from 1-year follow-up .
RESULTS	There were no differences based on treatment group assignment in either relapse from full remission or new remission during long-term follow-up .
RESULTS	Other psychopathology was stable over time .
CONCLUSIONS	There were few changes in the clinical presentation of participants who were assessed at long-term follow-up .
CONCLUSIONS	These data suggest that outcomes are generally stable posttreatment regardless of treatment type once remission is achieved .
CONCLUSIONS	Clinical trial registration information-Effectiveness of Family-Based Versus Individual Psychotherapy in Treating Adolescents With Anorexia Nervosa ; http://www.clinicaltrials.gov/; NCT00149786 .

###24754891
BACKGROUND	Coronary artery bypass grafting using the radial artery has , since the 1990s , gone through a revival .
BACKGROUND	Observational studies have indicated better long-term patency when using radial arteries .
BACKGROUND	Therefore , radial artery might be preferred especially in younger patients where long time patency is important .
BACKGROUND	During the last 10years different endoscopic techniques to harvest the radial artery have evolved .
BACKGROUND	Endoscopic radial artery harvest only requires a small incision near the wrist in contrast to open harvest , which requires an incision from the elbow to the wrist .
BACKGROUND	However , it is unknown whether the endoscopic technique results in fewer complications or a graft patency comparable to open harvest .
BACKGROUND	When the radial artery has been harvested , there are two ways to use the radial artery as a graft .
BACKGROUND	One way is sewing it onto the aorta and another is sewing it onto the mammary artery .
BACKGROUND	It is unknown which technique is the superior revascularisation technique .
METHODS	The NEO Trial is a randomised clinical trial with a 22 factorial design .
METHODS	We plan to randomise 300 participants into four intervention groups : ( 1 ) mammario-radial endoscopic group ; ( 2 ) aorto-radial endoscopic group ; ( 3 ) mammario-radial open surgery group ; and ( 4 ) aorto-radial open surgery group.The hand function will be assessed by a questionnaire , a clinical examination , the change in cutaneous sensibility , and the measurement of both sensory and motor nerve conduction velocity at 3months postoperatively .
METHODS	All the postoperative complications will be registered , and we will evaluate muscular function , scar appearance , vascular supply to the hand , and the graft patency including the patency of the central radial artery anastomosis .
METHODS	A patency evaluation by multi-slice computer tomography will be done at one year postoperatively.We expect the nerve conduction studies and the standardised neurological examinations to be able to discriminate differences in hand function comparing endoscopic to open harvest of the radial artery .
METHODS	The trial also aims to show if there is any patency difference between mammario-radial compared to aorto-radial revascularisation techniques but this objective is exploratory .
BACKGROUND	ClinicalTrials.gov identifier : NCT01848886.Danish Ethics committee number : H-3-2012-116 .
BACKGROUND	Danish Data Protection Agency : 2007-58-0015 / jr. n :30 -0838 .

###24284437
BACKGROUND	Knowledge of essential amino acid requirements in infants is important because excessive intake of protein can lead to increased long-term morbidity such as obesity .
BACKGROUND	A deficient intake may lead to suboptimal growth and impaired neurodevelopment .
BACKGROUND	The current recommended branched-chain amino acid requirements in infants aged 0-1 mo are based on the amino acid content of human milk .
OBJECTIVE	We quantified the requirements for isoleucine , leucine , and valine for term neonates by using the indicator amino acid oxidation method with [ 1 - ( 13 ) C ] phenylalanine as the indicator .
METHODS	Fully enterally fed term infants received randomly graded amounts of isoleucine ( 5-216 mg kg ( -1 ) d ( -1 ) ) , leucine ( 5-370 mg kg ( -1 ) d ( -1 ) ) , or valine ( 5-236 mg kg ( -1 ) d ( -1 ) ) as part of an elemental formula .
METHODS	Data are expressed as means SDs .
RESULTS	Eighty-three Asian , term neonates ( mean SD birth weight : 3.3 0.4 kg ; gestational age : 39.4 1.3 wk ) were studied at a postnatal age of 13 5 d. Mean requirements for isoleucine , leucine , and valine ( measured in boys only ) were 105 mg kg ( -1 ) d ( -1 ) ( r ( 2 ) = 0.61 , P < 0.001 ) , 140 mg kg ( -1 ) d ( -1 ) ( r ( 2 ) = 0.26 , P < 0.01 ) , and 110 mg kg ( -1 ) d ( -1 ) ( r ( 2 ) = 0.35 , P = 0.001 ) , respectively .
CONCLUSIONS	Current human milk-based recommendations for isoleucine and valine in term infants aged 0-1 mo are correct .
CONCLUSIONS	However , the current recommendation for leucine ( 166 mg kg ( -1 ) d ( -1 ) ) is higher than the mean requirement of 140 mg kg ( -1 ) d ( -1 ) that we determined in this study .
CONCLUSIONS	This trial was registered at www.trialregister.nl as NTR1610 .

###25585779
OBJECTIVE	We wanted to confirm the benefit of mometasone furoate ( MF ) in preventing acute radiation reactions , as shown in a previous study ( Bostrm et al , Radiother Oncol 2001 ; 59:257 -265 ) .
METHODS	The study was a double-blind comparison of MF with D ( Diprobase ) , administered daily from the start of radiation therapy for 5 weeks in patients receiving breast radiation therapy , 40 Gy in 2.67-Gy fractions daily over 3 weeks .
METHODS	The primary endpoint was mean modified Radiation Therapy Oncology Group ( RTOG ) score .
RESULTS	Mean RTOG scores were significantly less for MF than for D ( P = .046 ) .
RESULTS	Maximum RTOG and mean erythema scores were significantly less for MF than for D ( P = .018 and P = .012 , respectively ) .
RESULTS	The Dermatology Life Quality Index ( DLQI ) score was significantly less for MF than for D at weeks 4 and 5 when corrected for Hospital Anxiety and Depression ( HAD ) questionnaire scores .
CONCLUSIONS	MF cream significantly reduces radiation dermatitis when applied to the breast during and after radiation therapy .
CONCLUSIONS	For the first time , we have shown a significantly beneficial effect on quality of life using a validated instrument ( DLQI ) , for a topical steroid cream .
CONCLUSIONS	We believe that application of this cream should be the standard of care where radiation dermatitis is expected .

###24332668
OBJECTIVE	To compare the interstage cardiac catheterization hemodynamic and angiographic findings between shunt types for the Pediatric Heart Network Single Ventricle Reconstruction trial .
OBJECTIVE	The trial , which randomized subjects to a modified Blalock-Taussig shunt ( MBTS ) or right ventricle-to-pulmonary artery shunt ( RVPAS ) for the Norwood procedure , demonstrated the RVPAS was associated with a smaller pulmonary artery diameter but superior 12-month transplant-free survival .
METHODS	We analyzed the pre-stage II catheterization data for the trial subjects .
METHODS	The hemodynamic variables and shunt and pulmonary angiographic data were compared between shunt types ; their association with 12-month transplant-free survival was also evaluated .
RESULTS	Of 549 randomized subjects , 389 underwent pre-stage II catheterization .
RESULTS	A smaller size , lower aortic and superior vena cava saturation , and higher ventricular end-diastolic pressure were associated with worse 12-month transplant-free survival .
RESULTS	The MBTS group had a lower coronary perfusion pressure ( 27 vs 32 mm Hg ; P < .001 ) and greater pulmonary blood flow/systemic blood flow ratio ( 1.1 vs 1.0 , P = .009 ) .
RESULTS	A greater pulmonary blood flow/systemic blood flow ratio increased the risk of death or transplantation only in the RVPAS group ( P = .01 ) .
RESULTS	The MBTS group had fewer shunt ( 14 % vs 28 % , P = .004 ) and severe left pulmonary artery ( 0.7 % vs 9.2 % , P = .003 ) stenoses , larger mid-main branch pulmonary artery diameters , and greater Nakata indexes ( 164 vs 134 , P < .001 ) .
CONCLUSIONS	Compared with the RVPAS subjects , the MBTS subjects had more hemodynamic abnormalities related to shunt physiology , and the RVPAS subjects had more shunt or pulmonary obstruction of a severe degree and inferior pulmonary artery growth at pre-stage II catheterization .
CONCLUSIONS	A lower body surface area , greater ventricular end-diastolic pressure , and lower superior vena cava saturation were associated with worse 12-month transplant-free survival .

###24379356
OBJECTIVE	It has been hypothesized that the development of diabetic polyneuropathy ( DPN ) is due to swelling of the nerve , as well as thickening and stiffening of the surrounding ligaments , causing chronic compression of nerves .
OBJECTIVE	We aimed to examine the effect of surgical decompression of the tibial nerve on the mean cross-sectional area ( CSA ) .
METHODS	We performed a randomized controlled trial of 42 subjects with painful DPN diagnosed using the Diabetic Neuropathy Score .
METHODS	A computer randomized for the surgery arm of the study .
METHODS	A control group consisting of 38 healthy subjects was included .
METHODS	An experienced sonographer measured the CSA and thickness-to-width ( T/W ) ratio of the tibial nerve , as well as the thickness of the flexor retinaculum .
RESULTS	CSA is significantly larger in patients with painful DPN ( 8.4 3.9 mm ( 2 ) ) than in control subjects ( 6.4 1.3 mm ( 2 ) ) , P = 0.007 .
RESULTS	The T/W ratio in patients with painful DPN is 0.64 and in control subjects 0.59 , P = 0.03 .
RESULTS	Patients with DPN have a significantly thicker retinaculum ( 1.07 mm ) than control subjects ( 0.84 mm ) , P < 0.001 .
RESULTS	Mean follow-up was 28.2 weeks ( range 23-45 ) .
RESULTS	Difference between baseline and follow-up in the operated leg was 1.49 mm ( 2 ) and in the control leg 1.81 mm ( 2 ) , P = 0.674 .
CONCLUSIONS	Decompression of the tibial nerve does not result in a significant difference between baseline and follow-up in CSA using ultrasound between the operated and control leg .
CONCLUSIONS	Ultrasound measurements show a significantly increased CSA , a significantly thicker retinaculum , and a significantly increased T/W ratio in patients with painful DPN compared with healthy control subjects .
CONCLUSIONS	Clinical trial reg .
CONCLUSIONS	no .
CONCLUSIONS	NTR2344 , www.trialregister.nl .

###25018097
BACKGROUND	A community-based randomized trial was conducted in Costa Rica to evaluate the HPV-16 / 18 AS04-adjuvanted vaccine ( NCT00128661 ) .
BACKGROUND	The primary objective was to evaluate efficacy of the vaccine to prevent cervical intraepithelial neoplasia 2 or more severe disease ( CIN2 + ) associated with incident HPV-16 / 18 cervical infections .
BACKGROUND	Secondary objectives were to evaluate efficacy against CIN2 + associated with incident cervical infection by any oncogenic HPVs and to evaluate duration of protection against incident cervical infection with HPV-16 / 18 .
BACKGROUND	Vaccine safety and immunogenicity over the 4-year follow-up were also evaluated .
METHODS	We randomized ( 3727 HPV arm ; 3739 control arm ) , vaccinated ( HPV-16 / 18 or Hepatitis A ) and followed ( median 53.8 months ) 7466 healthy women aged 18-25 years .
METHODS	5312 women ( 2635 HPV arm ; 2677 control arm ) were included in the according to protocol analysis for efficacy .
METHODS	The full cohort was evaluated for safety .
METHODS	Immunogenicity was considered on a subset of 354 ( HPV-16 ) and 379 ( HPV-18 ) women .
METHODS	HPV type was assessed by PCR on cervical specimens .
METHODS	Immunogenicity was assessed using ELISA and inhibition enzyme immunoassays .
METHODS	Disease outcomes were histologically confirmed .
METHODS	Vaccine efficacy and 95 % confidence intervals ( 95 % CI ) were computed .
RESULTS	Vaccine efficacy was 89.8 % ( 95 % CI : 39.5-99 .5 ; N = 11 events total ) against HPV-16 / 18 associated CIN2 + , 59.9 % ( 95 % CI : 20.7-80 .8 ; N = 39 events total ) against CIN2 + associated with non-HPV-16 / 18 oncogenic HPVs and 61.4 % ( 95 % CI : 29.5-79 .8 ; N = 51 events total ) against CIN2 + irrespective of HPV type .
RESULTS	The vaccine had an acceptable safety profile and induced robust and long-lasting antibody responses .
CONCLUSIONS	Our findings confirm the high efficacy and immunogenicity of the HPV-16 / 18 vaccine against incident HPV infections and cervical disease associated with HPV-16 / 18 and other oncogenic HPV types .
CONCLUSIONS	These results will serve as a benchmark to which we can compare future findings from the ongoing extended follow-up of participants in the Costa Rica trial .
BACKGROUND	Registered with clinicaltrials.gov : NCT00128661 .

###24736930
BACKGROUND	There is a long-held concept among spine surgeons that endoscopic lumbar discectomy procedures are reserved for small-contained disc herniation ; 8-year follow-up has not been reported .
BACKGROUND	The purpose of this study is to assess microendoscopic discectomy ( MED ) in patients with large uncontained lumbar disc herniation ( the antero-posterior diameter of the extruded fragment is 6-12 mm or more on axial cuts of MRI ) and report long-term outcome .
METHODS	One hundred eighty-five patients with MED or standard open discectomy underwent follow-up for 8 years .
METHODS	Primary ( clinical ) outcomes data included Numerical Rating Scale ( NRS ) for back and leg symptoms and Oswestry Disability Index ( ODI ) to quantify pain and disability , respectively .
METHODS	Secondary ( objective ) outcomes data included operative time , blood loss , postoperative analgesics , length of hospital stay , time to return to work , reoperation and complication rate , patient satisfaction index ( PSI ) , and modified ( MacNab ) criteria .
RESULTS	At the end of the follow-up , the leg pain relief was statistically significant for both groups .
RESULTS	NRS back pain , ODI , PSI and MacNab criteria showed significant deterioration for control group .
RESULTS	Secondary outcomes data of MED group were significantly better than the control group .
CONCLUSIONS	Large , uncontained , lumbar disc herniations can be sufficiently removed using MED which is an effective alternative to open discectomy procedures with remarkable long-term outcome .
CONCLUSIONS	Although the neurological outcome of the two procedures is the same , the morbidity of MED is significantly less than open discectomy .
CONCLUSIONS	Maximum benefit can be gained if we adhere to strict selection criteria .
CONCLUSIONS	The optimum indication is single - or multi-level radiculopathy secondary to a single-level , large , uncontained , lumbar disc herniation .

###25498992
BACKGROUND	Heart failure ( HF ) patients suffer from frequent and repeated hospitalizations , causing a substantial economic burden on society .
BACKGROUND	Hospitalizations can be reduced considerably by better compliance with self-care .
BACKGROUND	Home telemonitoring has the potential to boost patients ' compliance with self-care , although the results are still contradictory .
OBJECTIVE	A randomized controlled trial was conducted in order to study whether the multidisciplinary care of heart failure patients promoted with telemonitoring leads to decreased HF-related hospitalization .
METHODS	HF patients were eligible whose left ventricular ejection fraction was lower than 35 % , NYHA functional class 2 , and who needed regular follow-up .
METHODS	Patients in the telemonitoring group ( n = 47 ) measured their body weight , blood pressure , and pulse and answered symptom-related questions on a weekly basis , reporting their values to the heart failure nurse using a mobile phone app .
METHODS	The heart failure nurse followed the status of patients weekly and if necessary contacted the patient .
METHODS	The primary outcome was the number of HF-related hospital days .
METHODS	Control patients ( n = 47 ) received multidisciplinary treatment according to standard practices .
METHODS	Patients ' clinical status , use of health care resources , adherence , and user experience from the patients ' and the health care professionals ' perspective were studied .
RESULTS	Adherence , calculated as a proportion of weekly submitted self-measurements , was close to 90 % .
RESULTS	No difference was found in the number of HF-related hospital days ( incidence rate ratio [ IRR ] = 0.812 , P = .351 ) , which was the primary outcome .
RESULTS	The intervention group used more health care resources : they paid an increased number of visits to the nurse ( IRR = 1.73 , P < .001 ) , spent more time at the nurse reception ( mean difference of 48.7 minutes , P < .001 ) , and there was a greater number of telephone contacts between the nurse and intervention patients ( IRR = 3.82 , P < .001 for nurse-induced contacts and IRR = 1.63 , P = .049 for patient-induced contacts ) .
RESULTS	There were no statistically significant differences in patients ' clinical health status or in their self-care behavior .
RESULTS	The technology received excellent feedback from the patient and professional side with a high adherence rate throughout the study .
CONCLUSIONS	Home telemonitoring did not reduce the number of patients ' HF-related hospital days and did not improve the patients ' clinical condition .
CONCLUSIONS	Patients in the telemonitoring group contacted the Cardiology Outpatient Clinic more frequently , and on this way increased the use of health care resources .
BACKGROUND	Clinicaltrials.gov NCT01759368 ; http://clinicaltrials.gov/show/NCT01759368 ( Archived by WebCite at http://www.webcitation.org/6UFxiCk8Z ) .

###24411490
OBJECTIVE	Probiotics help maintain balance in composition of the gut microbiota , and have been considered as a potential treatment for obesity .
OBJECTIVE	This study was conducted in order to assess the effects of probiotics when combined with herbal medicine in treatment of obesity .
OBJECTIVE	Probiotics were tested for the ability to modulate gut microbiota , gut permeability , and endotoxin level , which may have correlation with factors involved in obesity .
METHODS	A randomized , double-blind , placebo controlled study was conducted , in which patients with higher BMI ( > 25kg/m ( 2 ) ) and waist circumference ( > 85cm ) were enrolled and randomly assigned to receive Bofutsushosan with either probiotics or placebo capsules for a period of eight weeks .
METHODS	Assessment of body composition parameters , metabolic biomarkers , endotoxin level , gut permeability , and fecal bacteria in stool was performed at baseline and at week 8 .
METHODS	The study was registered at the Clinical Research Information Service , approved by the Korea National Institute of Health ( KCT0000386 ) .
RESULTS	Although both groups showed a significant reduction in weight and waist circumference ( p = 0.000 ) , no significant differences in body composition and metabolic markers were observed .
RESULTS	In correlation analysis , change in body composition showed positive correlation with endotoxin level ( r = 0.441 , p < 0.05 for BW ; and r = 0.350 , p < 0.05 for fat mass ) and the population of gut Lactobacillus plantarum ( r = 0.425 , p < 0.05 for BW ; and r = 0.407 , p < 0.05 for BMI ) .
RESULTS	The Gram negative bacterial population in gut also exhibited positive correlation with changes in body composition ( WC ) and total cholesterol level ( r = 0.359 , and 0.393 , for the former and later parameters , respectively , p < 0.05 for both ) .
RESULTS	While , the profile of gut Bifidobacterium breve population showed negative correlation with endotoxin level ( r = -0.350 , p < 0.05 ) .
CONCLUSIONS	Correlations between gut microbiota and change in body composition indicate that probiotics may influence energy metabolism in obesity .
CONCLUSIONS	Correlation between endotoxin level and weight reduction indicates that probiotics may play an important role in prevention of endotoxin production , which can lead to gut microbiota dysbiosis associated with obesity .

###24471516
OBJECTIVE	The objective of this study is to analyze the effects of a 12-week indoor intermittent training program on lung function , physical capacity , body composition and quality of life in children with asthma .
METHODS	Participants were randomized in an experimental group ( EG , 58 children , age = 11.551.01 years ) and in a control group ( CG , 47 children , age = 11.511.42 years ) .
METHODS	The training program was conducted indoors and consisted of alternating high - and low-intensity stimuli , for three sessions of 60min/week , for 12 weeks .
METHODS	Physical exercise and sports activities were organized to follow the criteria of the American College of Sports Medicine ( 1999 ) and previous interventions ' studies .
RESULTS	In EG , there was a significant improvement ( p < 0.05 ) in FEV1 , FEV6 , 6MWT , handgrip strength , CMJ and flexibility .
RESULTS	Reductions in BMI and fat mass as well as an increase in quality of life were all shown .
RESULTS	The dyspnea index decreased significantly and there were no episodes of EIA .
RESULTS	There is a significant positive correlation ( p < 0.01 ) between the FEV1 with handgrip strength and 6MWT and a negative correlation with fat mass .
CONCLUSIONS	An indoor intermittent training program with these characteristics has improved lung function , physical capacity , body composition and quality of life in children with asthma .
CONCLUSIONS	These training adaptations are particularly relevant for those patients suffering from asthma as a regular physical exercise routine will greatly improve their quality of life .

###26255514
OBJECTIVE	To observe the efficacy of catgut implantation at back-shu points in treatment of mild perimenopausal depression of kidney , deficiency and liver stagnation syndrome and analyze its essential function on target symptoms .
METHODS	Forty-five cases were randomized into a catgut implantation group ( 23 cases ) and atid acupuncture group ( 22 cases ) .
METHODS	In the catgut implantation group , catguts were implanted at Shenshu ( BL 23 ) , Ganshu ( BL 18 ) , Xinshu ( BL 15 ) , Pishu ( BL 20 ) , etc. , once every week .
METHODS	In the acupuncture group , the conventional acupuncture was applied to the same acupoints as the catgut implantation group , once every two days .
METHODS	The : treatment of 4 weeks made one session , and continuous 2 sessions were required .
METHODS	The efficacy was evaluated in , 2 sessions .
METHODS	The follow-up started in the 12th week .
METHODS	Before treatment , after treatment and in the follow-up period , Kupperman score and the total score in Hamilton depression scale ( HAMD ) , as well as the factor score were observed in the patients separately .
RESULTS	Kupperman score , the total HAMD score and the scores in the items of anxiety/somatization , retardation , sleep disorder and cognitive disorder after treatment were all reduced significantly as compared with those before treatment in the two groups ( P < 0.01 , P < 0.05 ) .
RESULTS	In the follow-up period , the difference in Kupperman was not significant in comparison with that after treatment in the catgut implantation : group ( P > 0.05 ) .
RESULTS	The total HAMD score and sleep disorder were reduced significantly as compared with those after treatment in the catgut implantation group ( both P < 0.01 ) ; in the acupuncture group , Kupperman score , the total HAMD score and sleep disorder were all increased as compared with those after treatment ( all P < 0.05 ) .
RESULTS	In ; the catgut implantation group , the total HAMD score was lower than that in the acupuncture group ( P < 0.05 ) , and the scores in the items of retardation and sleep disorder were reduced significantly as compared with those in the acupuncture group ( both P < 0.01 ) .
CONCLUSIONS	The catgut implantation at back-shu points alleviates perimenopasual sympton is in patients of mild perimenopausal depression of kidney deficiency and liver stagnation syndrome .
CONCLUSIONS	This therapy effectively relieves depressive disorders by regulating the target symptoms such as anxiety / somatization , retardation , sleep disorder and cognitive ' disorder .
CONCLUSIONS	The long-term efficacy of this therapy is better than the conventional acupuncture .

###24952391
OBJECTIVE	Up to 25 % of patients who undergo a percutaneous coronary intervention show some limitation in the use of drug-eluting stents .
OBJECTIVE	The aim of this study was to evaluate if titanium-nitride-oxide-coated stents could be a good alternative to everolimus-eluting stents in diabetic patients .
METHODS	A total of 173 diabetic patients with lesions at moderate risk of restenosis ( exclusion criteria : diameter < 2.5 mm or length > 28 mm in vessels < 3mm , chronic occlusion ) were randomized to a titanium group ( 83 patients ) or an everolimus group ( 90 patients ) .
RESULTS	Baseline characteristics were well balanced ; 28.3 % of patients were insulin dependent .
RESULTS	At 1 year , the incidence of major adverse cardiac events ( death , nonfatal myocardial infarction , stroke , or repeat target vessel revascularization ) was significantly higher in the titanium group than in the everolimus group ( total , 14.5 % vs 4.4 % ; P = .02 ; noninsulin-dependent subgroup , 9.7 % vs 3.2 % ; P = .14 ; insulin-dependent subgroup , 28.6 % vs 7.1 % ; P = .04 ) .
RESULTS	The incidence of death , nonfatal myocardial infarction , stroke , or any revascularization was 16.9 % in the titanium group and 7.8 % in the everolimus group ( P = .06 ) .
RESULTS	Target lesion and vessel revascularizations occurred in 8.4 % compared with 3.3 % ( P = .15 ) and in 13.3 % compared with 3.3 % ( P = .01 ) in the titanium and everolimus groups , respectively .
RESULTS	Angiographic follow-up at 9 months showed significantly less late lumen loss in the everolimus group ( in-segment , 0.52 [ standard deviation , 0.58 ) mm vs -0.05 [ 0.32 ] mm ; in-stent , 0.76 [ 0.54 ] mm vs 0.13 [ 0.31 ] mm ; P < .0001 ) .
CONCLUSIONS	The everolimus-eluting stent is superior to the titanium stent for clinical and angiographic end points in diabetic patients with lesions at moderate risk of restenosis .

###25516006
OBJECTIVE	To evaluate the safety of the fixed combination of ibuprofen and famotidine compared with ibuprofen alone from two 24-week , multicenter , double-blind trials designed to evaluate the comparative incidence of endoscopically documented upper gastrointestinal ulcers and a 28-week double-blind extension study .
METHODS	Safety was analyzed by pooling data from the two double-blind trials and the follow-on study .
METHODS	Safety was assessed by monitoring the incidence , causality , and severity of adverse events ( AEs ) .
RESULTS	In the pivotal efficacy and safety trials , discontinuation rates due to any cause and dyspepsia were significantly lower for the ibuprofen/famotidine combination versus ibuprofen alone .
RESULTS	Other than dyspepsia , gastrointestinal and cardiovascular AEs of special interest were similar .
RESULTS	Events judged to be treatment related were significantly lower with the ibuprofen/famotidine combination ( 20.6 % vs. 25 % ) .
RESULTS	In the safety extension population , there were no differences in the discontinuation rates and the reporting of AEs or serious AEs ( SAEs ) between the two groups .
RESULTS	Gastrointestinal-related events were similar between the groups .
RESULTS	Incidence of cardiovascular-related AEs of special interest were 11 % ( ibuprofen/famotidine ) and 2 % ( ibuprofen ) ( p = 0.06 ) , possibly due to a higher number of rheumatoid arthritis patients in the combination group .
RESULTS	Of these , 80 % were reports of hypertension ( 8 % ibuprofen/famotidine vs. 2 % ibuprofen ) .
RESULTS	Three cases of hypertension in the ibuprofen/famotidine group were considered treatment related .
RESULTS	The probability of a cardiovascular event decreased during days 112-167 of treatment and remained low with continued treatment .
CONCLUSIONS	One-year safety data from two pivotal trials and a long-term extension study indicate that the ibuprofen/famotidine combination demonstrates a favorable gastrointestinal safety profile and more patients continued on therapy compared to ibuprofen alone .
CONCLUSIONS	No new safety signals have been identified .
CONCLUSIONS	These data offer additional evidence supporting a new therapeutic option to improve gastrointestinal safety and adherence for patients who require long-term ibuprofen .

###24851689
OBJECTIVE	To compare the effects of volume-controlled ventilation ( VCV ) and pressure-controlled volume-guaranteed ( PCV-VG ) mode during one-lung ventilation ( OLV ) on circulation , pulmonary function and lung injury .
METHODS	2012 February to 2013 March in Ningbo No2 .
METHODS	Hospital cardiothoracic surgery , 30 patients aged 52 to 76 years ( ASA grade II-III ) undergoing elective thoracoscopic lobectomy were randomly divided into VCV group and PCV-VG group , with 15 cases in each group .
METHODS	After anesthesia induction and endotracheal intubation , endobronchial blocker was inserted to start OLV .
METHODS	Heart rate ( HR ) , mean arterial pressure ( MAP ) , measured tidal volume ( TV ) , peak airway pressure ( Ppeak ) , airway resistance ( Raw ) , chest compliance ( Cdyn ) and the end-tidal carbon dioxide pressure ( PetCO ( 2 ) ) were recorded at the time point of 15 minutes after turning to the lateral position , 15 minutes and 60 minutes after OLV , and 15 minutes after the resumption of two lung ventilation .
METHODS	In the meanwhile , arterial blood gas analysis was conducted to measure indicators of pH , oxygen tension ( PaO ( 2 ) ) and carbon dioxide partial pressure ( PaCO ( 2 ) ) .
METHODS	Blood was drawn before induction , 1 hour after OLV and 1 hour after the end of surgery , and the concentration of interleukin-6 ( IL-6 ) and tumor necrosis factor-alpha ( TNF - ) were detected by enzyme-linked immunosorbent assay ( ELISA ) .
RESULTS	HR , MAP , TV , PetCO ( 2 ) , pH and PaCO ( 2 ) in two groups at the time point of 15 minutes after turning to the lateral position , 15 minutes and 60 minutes after OLV , and 15 minutes after the resumption of two lung ventilation showed no significant difference ( P > 0.05 ) .
RESULTS	At the point of 15 minutes after turning to the lateral position and 15 minutes after two lung ventilation , Ppeak and Cdyn of two groups were significantly different ( P < 0.05 ) ( Ppeak :16 3 cmH ( 2 ) O , 16 3 cmH ( 2 ) O for VCV group and 14 2 cmH ( 2 ) O , 14 2 cmH ( 2 ) O for PCV-VG group ; Cdyn : 43.5 5.9 ml/cmH ( 2 ) O , 43.8 6.7 ml/cmH2O for VCV group and 49.7 7.1 ml/cmH ( 2 ) O , 53.3 9.6 ml/cmH ( 2 ) O for PCV-VG group ) .
RESULTS	Compared with VCV group , PCV-VG group showed a lower Ppeak 15 minutes and 60 minutes after OLV [ ( 17 2 cmH ( 2 ) O ) vs ( 22 4 cmH ( 2 ) O ) and ( 18 4 cmH ( 2 ) O ) vs ( 23 3 cmH ( 2 ) O ) with a higher Cdyn at the same point ( 38.6 6.3 ml/cmH ( 2 ) O ) vs ( 29.6 3.2 ml/cmH ( 2 ) O ) and 37.3 6.0 ml/cmH ( 2 ) O ) vs ( 30.3 3.8 ml/cmH ( 2 ) O ) ] ( P < 0.01 ) .
RESULTS	Compared with VCV group,IL-6 and TNF - of PCV-VG group 1 hour after OLV and 1 hour after the end of surgery were significantly lower ( P < 0.01 ) ( IL-6 : 52.32 3.59 vs 62.65 4.17 pg/ml and 63.57 4.98 vs 82.38 4.10 pg/ml ; TNF - : 3.23 0.27 vs 4.19 0.38 pg/ml and 4.01 0.28 vs. 5.49 0.31 pg/ml ) .
CONCLUSIONS	During one-lung ventilation in thoracoscopic lobectomy , PCV-VG mode has a competitive advantage over VCV mode in terms of pulmonary function and lung protection .

###24748400
OBJECTIVE	We compared the recovery profile of propofol and sevoflurane when used for maintenance of anesthesia in elective day care operative procedures .
METHODS	One hundred ASA physical status I and II patients , aged between 18 and 50 years , were randomly assigned to receive either propofol-nitrous oxide or sevoflurane-nitrous oxide maintenance of anesthesia .
METHODS	Early and intermediate recovery in terms of cognitive and ambulatory functions was recorded .
METHODS	Psychomotor testing , in the form of Trieger dot test and digit symbol substitution test , were performed before surgery and in the post-anesthesia care unit at 15 min , 30 min , 1 h , 2 h , and 4 h following nitrous oxide switch-off to evaluate intermediate recovery .
RESULTS	There were no significant differences in recovery of early cognitive functions between the two groups , except that patients in the sevoflurane group were more responsive at around 10 min following nitrous oxide switch-off and `` recalled address '' earlier than patients in the propofol group .
RESULTS	There was no significant difference in between the two groups with regard to `` home-readiness . ''
CONCLUSIONS	Recovery from sevoflurane anesthesia , especially with regard to cognitive functions , may be slightly faster than from propofol , but the difference is not sufficiently significant to affect the time to `` home-readiness '' in patients undergoing day care surgery .

###24594499
BACKGROUND	Vertigo imposes considerable health restrictions with significant impact on the patient 's quality of life .
BACKGROUND	The most effective antivertigo agent is undetermined thus far .
OBJECTIVE	This study was performed to assess whether promethazine has superior vertigo reduction compared with lorazepam in ED patients .
METHODS	In this randomized , double-blind , parallel group trial 184 patients were assigned ( 1:1 ratio ) to receive either promethazine , 25 mg intravenously , or lorazepam , 2 mg intravenously .
METHODS	Primary endpoint was mean change in vertigo intensity at 2 hours measured using visual analog scale ( VAS ) .
METHODS	Secondary endpoints were mean change in nausea score , need for second dose of study medications , and adverse events ( AEs ) .
RESULTS	Promethazine was associated with significantly more reduction ( 46.5 mm ) in vertigo than lorazepam ( 25.7 mm , p < 0.001 ) .
RESULTS	Mean change in nausea score 2 hours after drug injection on the VAS was 28.7 mm for promethazine and 22.8 for lorazepam ( p = 0.002 ) .
RESULTS	The most frequently reported AEs were lethargy ( 14.1 % in lorazepam group , 4.3 % in promethazine group , p = 0.013 ) and drowsiness ( 10.8 % for promethazine , 2.1 % for lorazepam , p = 0.017 ) .
CONCLUSIONS	Our study demonstrated the evidence that promethazine is superior to lorazepam in management of peripheral vertigo and vertigo-related nausea in ED adults .

###24604111
BACKGROUND	During lower limb lengthening , distraction-induced muscle pain and surrounding joint contractures are frustrating complications for which few effective treatments are available .
OBJECTIVE	We evaluated Botulinum Toxin Type A ( BtX-A ) injection in the calf muscles during human tibial distraction osteogenesis .
OBJECTIVE	We hypothesized that it may decrease calf pain and increase ROM of the surrounding joints by reducing muscle stiffness .
METHODS	Between April 2010 and January 2011 , we evaluated 36 patients undergoing bilateral tibia lengthening who met prespecified inclusion criteria .
METHODS	All patients underwent stature lengthening with lengthening over a nail or lengthening and then nailing .
METHODS	BtX-A ( 200IU ) was injected at the calf muscle only in one leg for each patient and the same amount of sterile normal saline was injected into the other leg as a control .
METHODS	Selection of the leg receiving the toxin was randomized .
METHODS	Clinical evaluation included a VAS score for calf pain and measurement of ROM of the knees and ankles and calf circumference , with evaluations performed in a double-blinded manner .
METHODS	Side-to-side differences were analyzed until the end of consolidation phase .
METHODS	Minimum followup was 24months ( mean , 30months ; range , 24-39months ) .
METHODS	The distraction rate and the final length gain were similar in the treated and control limbs .
METHODS	A priori power analysis suggested that 34 legs were required to achieve statistical significance of 0.05 with 80 % of power to detect a 50 % difference in treatment effect between treatment and control groups .
RESULTS	There were no differences in calf pain , knee and ankle ROM , and maximal calf circumferences between the two legs at each time point .
CONCLUSIONS	Local injection of 200IU BtX-A at the human calf muscle does not appear to reduce calf pain or help enhance ROM of the knee and ankle during tibial lengthening .
CONCLUSIONS	However , the small sample size provided sufficient power to detect only relatively large clinical effects ; future , larger trials will be needed to determine whether smaller differences are present .
METHODS	Level II , therapeutic study .
METHODS	See Instructions for Authors for a complete description of levels of evidence .

###25872390
OBJECTIVE	To assess potential of preoperative therapy with local steroid and non-steroid anti-inflammatory drugs ( SAIDs and NSAIDs ) for prolonging the hypotensive effect of trabeculectomy .
METHODS	A total of 80 patients with primary open-angle glaucoma planed for trabeculectomy were randomized into 4 groups of 20 each : 3 groups that differed in the studied drug ( nepafenac , dexamethasone , or their non-fixed combination ) and a control group with no preoperative therapy .
METHODS	The patients instilled 1 drop of either drug b.i.d. for 2 weeks before the surgery and were examined each day of the first week and then at weeks 1 , 2 , 4 and months 3 , 6 , and 12 .
METHODS	The rate of postoperative surgical and medical interventions ( needling , needling revision , hypotensive therapy ) was used for outcome evaluation .
RESULTS	Postoperative needling was required in 50 % of the controls , 35 % of the NSAIDs and 30 % of the SAIDs patients as well as 20 % the combination-therapy patients .
RESULTS	Needling revision had to be performed in 10 % of patients from the control group and 5 % of patients from the NSAIDs group .
RESULTS	Patients from the steroid and combination-therapy groups had no need in needling procedure .
RESULTS	Further hypotensive therapy was required in 50 % of the control group , 35 % of the NSAIDs group , 25 % of the SAIDs group and 20 % of the combination-therapy group .
RESULTS	During the first postoperative year complete success of the treatment was achieved in 50 % of the controls , 65 % of the NSAIDs patients , 75 % of the SAIDs patients , and 80 % of those under combination therapy .
RESULTS	Qualified success during the same period was achieved in 100 % of cases .
CONCLUSIONS	Preoperative local anti-inflammatory therapy helped to increase the one-year complete success rate after trabeculectomy as compared with the controls .
CONCLUSIONS	The most significant hypotensive effect was noted in the combination-therapy group ( 80 % ) , less significant -- in the steroid and non-steroid monotherapy groups ( 75 % and 65 % correspondingly ) .
CONCLUSIONS	A negative correlation was noted between the use of nepafenac and dexamethasone and other measures aimed at increasing the hypotensive effect of glaucoma surgery .

###25899215
METHODS	Case-control study ; ecological study .
OBJECTIVE	To examine the efficacy of wearing compression stockings to prevent muscle damage and to maintain running performance during a marathon competition .
BACKGROUND	Exercise-induced muscle damage has been identified as one of the main causes of the progressive decrease in running and muscular performance found during marathon races .
METHODS	Thirty-four experienced runners were pair-matched for age , anthropometric data , and best race time in the marathon , and randomly assigned to a control group ( n = 17 ) of runners who wore conventional socks or to a group of runners who wore foot-to-knee graduated compression stockings ( n = 17 ) .
METHODS	Before and after the race , a sample of venous blood was obtained , and jump height and leg muscle power were measured during a countermovement jump .
METHODS	Serum myoglobin and creatine kinase concentrations were determined as blood markers of muscle fiber damage .
RESULTS	Total race time was not different between the control group and the compression stockings group ( 210 23 and 214 22 minutes , respectively ; P = .58 ) .
RESULTS	Between the control group and the compression stockings group , postrace reductions in leg muscle power ( -19.8 % 17.7 % versus -24.8 % 18.4 % , respectively ; P = .37 ) and jump height ( -25.3 % 14.1 % versus -32.5 % .
RESULTS	20.4 % , respectively ; P = .27 ) were similar .
RESULTS	At the end of the race , there were no differences between the control group and the compression stockings group in serum myoglobin ( 568 347 ngmL ( -1 ) versus 573 270 ngmL ( -1 ) , respectively ; P = .97 ) and creatine kinase concentration ( 390 166 UL ( -1 ) versus 487 227 UL ( -1 ) , respectively ; P = .16 ) .
CONCLUSIONS	The use of compression stockings did not improve running pace and did not prevent exercise-induced muscle damage during the marathon .
CONCLUSIONS	Wearing compression stockings during long-distance running events is an ineffective strategy to avoid the deleterious effects of muscle damage on running performance .
METHODS	Therapy , level 2b .

###24361853
BACKGROUND	The relationships of left ventricular ( LV ) longitudinal and circumferential systolic dysfunction with diastolic performance in hypertensive patients have never been compared .
RESULTS	In 532 asymptomatic hypertensive patients , circumferential function was assessed with the use of midwall fractional shortening ( mFS ) and stress-corrected mFS ( SCmFS ) , whereas longitudinal function was assessed with the use of left atrioventricular plane displacement ( AVPD ) and systolic mitral annulus velocity ( s ' ) .
RESULTS	Early diastolic annular velocity ( e ' ) and the E/e ' ratio were measured .
RESULTS	Global longitudinal and circumferential strain were determined in a subset of 210 patients .
RESULTS	e ' was linearly related to all systolic indexes ( AVPD : R = 0.40 ; s ' : R = 0.39 ; mFS : R = 0.16 ; SCmFS : R = 0.17 ; all P < .0001 ) , but the correlations were stronger with longitudinal indexes than with circumferential ones ( P < .0001 ) .
RESULTS	E/e ' was nonlinearly related to AVPD ( R = -0.49 ; P < .0001 ) and s ' ( R = -0.34 ; P < .0001 ) and showed no relationship with mFS and SCmFS .
RESULTS	Longitudinal indexes were superior to circumferential ones in predicting e ' < 8 cm/s , E/e ' < 8 , and E/e ' 13 .
RESULTS	The effect of LV geometry on LV diastolic function was evident among patients with preserved systolic longitudinal function , but was blunted among patients with impaired longitudinal function .
RESULTS	In multivariable analyses , only longitudinal indexes remained associated with e ' and E/e ' .
RESULTS	Analyses using strains provided similar results .
CONCLUSIONS	In asymptomatic hypertensive subjects , LV diastolic performance is independently associated with longitudinal systolic dysfunction , but not with circumferential systolic dysfunction .
CONCLUSIONS	Subtle longitudinal systolic impairment plays a role in mediating the effect of LV geometry on diastolic performance .
CONCLUSIONS	These findings may support the need of critically revising the concept of isolated diastolic dysfunction in these patients .

###25395709
BACKGROUND	Multiple Sclerosis ( MS ) is a chronic and disabling disease resulting in disabilities in young and middle-aged persons .
BACKGROUND	In this study , researchers explored the effect of yoga techniques on physical activities and sexual function among some Iranian women with MS.
METHODS	In this study , 60 Iranian women with multiple sclerosis ( MS ) were placed in two equally divided control and case groups through random selection to assess pre-and post-effects of yoga exercises on their physical activities and sexual satisfaction levels .
METHODS	Women in case group were offered a series of yoga training and exercises for 3 months , which consisted of 8 sessions per month for 60 to 90 minutes at each session .
METHODS	Yoga training program included the 3 principles of slow motions ( Hatayoga ) , respiratory exercises ( Pranayama ) and centralization to control mind via meditation , expansion and stasis ( Rajayoga ) .
METHODS	After 3 months both groups were surveyed using the initial questionnaire to evaluate and compare findings with the base-line data .
RESULTS	Researchers found significant statistical difference in physical activity and sexual satisfaction levels among the women in case group ( P = 0.001 ) .
RESULTS	Women in case group showed improvement in physical ability while women in control group manifested exacerbated symptoms .
CONCLUSIONS	Yoga techniques may improve physical activities and sexual satisfaction function of women with MS.

###26080882
OBJECTIVE	To evaluate the safety and efficacy of antiplatelet therapy of ticagrelor on patients suffering from acute ST segment elevation myocardial infarction undergoing primary percutaneous coronary intervention .
METHODS	In the study , 96 patients suffering from acute ST segment elevation myocardial infarction onset within 12 h undergoing primary percutaneous coronary intervention from May to October in 2013 were randomly divided into ticagrelor group ( n = 48 ) and clopidogrel group ( n = 48 ) by using the method of random number table .
METHODS	Ticagrelor and clopidogrel antiplatelet treatment were used before and after operation .
METHODS	Their baseline data , coronary artery disease characteristics , platelet count , adenosine diphosphate ( ADP ) - induced platelet inhibition rate by thrombelastograph after 5 days of treatment , the major adverse cardiovascular events of the follow up for 6 months and bleeding complications were observed and compared in the two groups .
RESULTS	The differences between the two groups of patients with their baseline data , the features of coronary artery lesions , platelet count before and after 5 days of treatment had no statistical significance ( P > 0.05 ) .
RESULTS	ADP induced platelet inhibition rate [ ( 80.210.7 ) % ] after 5 days of treatment in ticagrelor group was significantly higher than that in clopidogrel group [ ( 75.312.1 ) % , P < 0.05 ] .
RESULTS	The two groups of patients were followed up for 6 months , 8 cases of major adverse cardiovascular events occurred in clopidogrel group , 2 cases of major adverse cardiovascular events occurred in ticagrelor group , and there was significant difference between the two groups ( P < 0.05 ) .
RESULTS	The two groups ( 7 cases of 48 patients in ticagrelor group vs. 3 cases of 48 patients in clopidogrel group ) had no statistically significant difference in bleeding complications ( P > 0.05 ) .
CONCLUSIONS	Antiplatelet therapy of ticagrelor on patients suffering from acute ST segment elevation myocardial infarction undergoing emergency PCI has good efficacy and safety .

###25100336
OBJECTIVE	To evaluate the image quality , radiation dose and diagnostic accuracy of 80kVp , high-pitch CT pulmonary angiography ( CTPA ) with iterative reconstruction using 20 ml of contrast agent .
METHODS	One hundred patients with suspected pulmonary embolism ( PE ) were randomly divided into two groups ( n = 50 each ; group A , 100 kVp , 1.2 pitch , 60 ml of contrast medium and filtered back projection algorithm ; group B , 80 kVp , 2.2 pitch , 20 ml of contrast medium and sinogram affirmed iterative reconstruction ) .
METHODS	Image quality , diagnostic accuracy and radiation dose were evaluated and compared .
RESULTS	Mean CT numbers of pulmonary arteries in group B were higher than those in group A ( all P < 0.001 ) .
RESULTS	Contrast-to-noise ratio and signal-to-noise ratio of group B were higher than those of group A ( both P < 0.001 ) .
RESULTS	There was no significant difference in subjective image quality scores between two groups ( P = 0.807 ) .
RESULTS	The interobserver agreement was excellent ( k = 0.836 ) .
RESULTS	There was no significant difference in diagnostic accuracy between the two groups ( P > 0.05 ) .
RESULTS	Compared with group A , radiation dose of group B was reduced by 50.3 % ( P < 0.001 ) .
CONCLUSIONS	High-pitch CTPA at 80 kVp can obtain sufficient image quality in normal-weight individuals with 20 ml of contrast agent and half the radiation dose of a conventional CTPA protocol .
CONCLUSIONS	CTPA is feasible at 80 kVp using only 20 ml of contrast agent .
CONCLUSIONS	High-pitch CTPA at 80 kVp has an effective dose under 1 mSv .
CONCLUSIONS	This CTPA protocol can obtain sufficient image quality in normal-weight individuals .

###25267532
BACKGROUND	Families express a need for guidance in helping their loved ones with anorexia nervosa ( AN ) .
BACKGROUND	Guided self-help interventions can offer support to caregivers .
METHODS	One hundred seventy-eight adult AN patients and their caregivers were recruited from 15 UK treatment centres .
METHODS	Families were randomized to carers ' assessment , skills and information sharing ( C ) intervention + treatment as usual ( TAU ) or TAU alone .
METHODS	Feedback forms were sent at 6months post-discharge and , if not returned , at 12months .
METHODS	One hundred two ( 57 % ) patient forms ( n = 50TAU ; n = 52C ) and 115 ( 65 % ) caregiver forms ( n = 60TAU ; n = 55C ) were returned .
METHODS	Two researchers coded data blind , using thematic analysis .
RESULTS	( i ) Caregivers and patients express a need for post-discharge support .
RESULTS	( ii ) Patients identify helpful and unhelpful support strategies , useful for developing future interventions .
RESULTS	( iii ) Patients could identify positive caregiver behaviour changes targeted in intervention .
RESULTS	( iv ) Guided self-help may benefit caregiver and sufferer , post-discharge .
CONCLUSIONS	Caregiver interventions can be a useful tool that will improve the cost effectiveness of inpatient treatment by enhancing the well-being of caregivers and patients .

###24799513
BACKGROUND	Cardiac mortality and electrophysiological dysfunction both increase with age .
BACKGROUND	Heart rate variability ( HRV ) provides indices of autonomic function and electrophysiology that are associated with cardiac risk .
BACKGROUND	How habitual physical activity among older adults prospectively relates to HRV , including nonlinear indices of erratic sinus patterns , is not established .
BACKGROUND	We hypothesized that increasing the levels of both total leisure-time activity and walking would be prospectively associated with more favorable time-domain , frequency-domain , and nonlinear HRV measures in older adults .
RESULTS	We evaluated serial longitudinal measures of both physical activity and 24-hour Holter HRV over 5 years among 985 older US adults in the community-based Cardiovascular Health Study .
RESULTS	After multivariable adjustment , greater total leisure-time activity , walking distance , and walking pace were each prospectively associated with specific , more favorable HRV indices , including higher 24-hour standard deviation of all normal-to-normal intervals ( Ptrend = 0.009 , 0.02 , 0.06 , respectively ) and ultralow-frequency power ( Ptrend = 0.02 , 0.008 , 0.16 , respectively ) .
RESULTS	Greater walking pace was also associated with a higher short-term fractal scaling exponent ( Ptrend = 0.003 ) and lower Poincar ratio ( Ptrend = 0.02 ) , markers of less erratic sinus patterns .
CONCLUSIONS	Greater total leisure-time activity , and walking alone , as well , were prospectively associated with more favorable and specific indices of autonomic function in older adults , including several suggestive of more normal circadian fluctuations and less erratic sinoatrial firing .
CONCLUSIONS	Our results suggest potential mechanisms that might contribute to lower cardiovascular mortality with habitual physical activity later in life .

###24573358
OBJECTIVE	Our aim was to compare anatomical and functional outcome between vaginal colposuspension and transvaginal mesh .
METHODS	This was a prospective randomized controlled trial in a teaching hospital .
METHODS	Sixty-eight women with stage 3 anterior vaginal wall prolapse according to the Pelvic Organ Prolapse Quantification ( POP-Q ) system were assessed , randomized , and analyzed .
METHODS	Patients were randomized to anterior colporrhaphy with vaginal colposuspension ( n = 35 ) or transvaginal mesh ( n = 33 ) .
METHODS	Primary outcome was objective cure rate of the anterior vaginal wall , defined as POP-Q 1 at 2years .
METHODS	Secondary outcomes were functional results , quality-of-life ( QoL ) scores , mesh-related morbidity , and onset of urinary incontinence .
RESULTS	The anatomical result for point Ba was significantly better at 2years in the mesh group ( -2.8 cm ) than in the colposuspension group ( -2.4 cm ) ( p = 0.02 ) .
RESULTS	Concerning POP-Q stages , the anatomical success rate at 2years was 84.4 % for colposuspension and 100 % for mesh ( p = 0.05 ) .
RESULTS	There were 5 anatomic recurrences ( 15.6 % ) in the colposuspension group .
RESULTS	The erosion rate was 6 % ( n = 2 ) .
RESULTS	No significant difference was noted regarding minor complications .
RESULTS	Analysis of QoL questionnaires showed overall improvement in both groups , with no significant difference between them .
CONCLUSIONS	The vaginal colposuspension technique of anterior vaginal wall prolapse repair gave good anatomical and functional results at 2years .
CONCLUSIONS	Transobturator vaginal mesh gave better 2-year anatomical results than vaginal colposuspension , with overall improvement in QoL in both groups .

###25249651
OBJECTIVE	Clinical studies evaluating the effects of medications on - cell function in type 2 diabetes ( T2DM ) are compromised by an inability to determine the actual baseline degree of - cell dysfunction independent of the reversible dysfunction induced by hyperglycemia ( glucotoxicity ) .
OBJECTIVE	Short-term intensive insulin therapy ( IIT ) is a strategy for eliminating glucotoxicity before randomization .
OBJECTIVE	This study determined whether liraglutide can preserve - cell function over 48 weeks in early T2DM following initial elimination of glucotoxicity with IIT .
METHODS	In this double-blind , randomized , placebo-controlled trial , 51 patients with T2DM of 2.6 1.9 years ' duration and an A1C of 6.8 0.8 % ( 51 8.7 mmol/mol ) completed 4 weeks of IIT before randomization to daily subcutaneous liraglutide or placebo injection , with serial assessment of - cell function by Insulin Secretion-Sensitivity Index-2 ( ISSI-2 ) on oral glucose tolerance test performed every 12 weeks .
RESULTS	The primary outcome of baseline-adjusted ISSI-2 at 48 weeks was higher in the liraglutide group than in the placebo group ( 339.8 27.8 vs. 229.3 28.4 , P = 0.008 ) .
RESULTS	Baseline-adjusted HbA1c at 48 weeks was lower in the liraglutide group ( 6.2 0.1 % vs. 6.6 0.1 % , P = 0.055 ) ( 44 1.1 vs. 49 1.1 mmol/mol ) .
RESULTS	At each quarterly assessment , > 50 % of participants on liraglutide had an HbA1c 6.0 % ( 42 mmol/mol ) and glucose tolerance in the nondiabetic range .
RESULTS	Despite this level of glycemic control , no difference was found in the incidence of hypoglycemia between the liraglutide and placebo groups ( P = 0.61 ) .
RESULTS	Two weeks after stopping treatment , however , the beneficial effect on ISSI-2 of liraglutide versus placebo was entirely lost ( 191.9 24.7 vs. 238.1 25.2 , P = 0.20 ) .
CONCLUSIONS	Liraglutide provides robust enhancement of - cell function that is sustained over 48 weeks in early T2DM but lost upon cessation of therapy .

###25110443
OBJECTIVE	To investigate the effectiveness of rectally administered indomethacin in the prophylaxis of post-endoscopic retrograde cholangiopancreatography ( ERCP ) pancreatitis and hyperamylasaemia in a multicentre study .
METHODS	A prospective , randomised , placebo-controlled multicentre study in five endoscopic units was conducted on 686 patients randomised to receive a suppository containing 100 mg indomethacin , or an inert placebo , 10-15 min before ERCP .
METHODS	Post-ERCP pancreatitis and hyperamylasaemia were evaluated 24 h following the procedure on the basis of clinical signs and laboratory parameters , and computed tomography/magnetic resonance imaging findings if required .
RESULTS	Twenty-one patients were excluded because of incompleteness of their data or because of protocol violation .
RESULTS	The results of 665 investigations were evaluated : 347 in the indomethacin group and 318 in the placebo group .
RESULTS	The distributions of the risk factors in the two groups did not differ significantly .
RESULTS	Pancreatitis developed in 42 patients ( 6.3 % ) : it was mild in 34 ( 5.1 % ) and severe in eight ( 1.2 % ) cases .
RESULTS	Hyperamylaesemia occurred in 160 patients ( 24.1 % ) .
RESULTS	There was no significant difference between the indomethacin and placebo groups in the incidence of either post-ERCP pancreatitis ( 5.8 % vs 6.9 % ) or hyperamylasaemia ( 23.3 % vs 24.8 % ) .
RESULTS	Similarly , subgroup analysis did not reveal any significant differences between the two groups .
CONCLUSIONS	100 mg rectal indomethacin administered before ERCP did not prove effective in preventing post-ERCP pancreatitis .

###24249722
BACKGROUND	We sought to determine the incidence of newly diagnosed diabetes in treated elderly hypertensive patients and the prognostic impact of diabetes on long-term survival .
METHODS	The Second Australian National Blood Pressure ( ANBP2 ) study randomized 6,083 hypertensive patients aged 65-84 years to angiotensin-converting enzyme inhibitor ( ACEI ) or thiazide diuretic-based therapy and followed them for a median of 4.1 years .
METHODS	Long-term survival was determined in 5,678 patients over an additional median of 6.9 years after ANBP2 ( post-trial ) .
RESULTS	After ANBP2 , the cohort was classified into preexisting ( 7.2 % ) , newly diagnosed ( 5.6 % ) , and no diabetes ( 87.2 % ) groups .
RESULTS	A 44 % higher incidence of newly diagnosed diabetes was observed in patients randomized to thiazide diuretic compared with ACEI-based treatment .
RESULTS	The other predictors of newly diagnosed diabetes were having a higher body mass index , having a higher random blood glucose , and living in a regional location compared to major cities ( a geographical classification based on accessibility ) at study entry .
RESULTS	After completion of ANBP2 , compared with those with no diabetes , the preexisting diabetes group experienced higher cardiovascular ( hazards ratio ( HR ) = 1.65 ; 95 % confidence interval ( CI ) = 1.03-2 .65 ) and all-cause mortality ( HR = 1.40 ; 95 % CI = 1.02-1 .92 ) when adjusted for age , sex , and treatment .
RESULTS	A similar pattern was observed after including the post-trial period for cardiovascular ( HR = 1.52 ; 95 % CI = 1.20-1 .93 ) and all-cause mortality ( HR = 1.50 ; 95 % CI = 1.29-1 .73 ) .
RESULTS	However , when the newly diagnosed group was compared with the no diabetes group , no significant difference was observed in cardiovascular ( HR = 0.33 ; 95 % CI = 0.11-1 .05 ) or all-cause mortality ( HR = 0.76 ; 95 % CI = 0.47-1 .23 ) either during the ANBP2 trial or including post-trial follow-up ( cardiovascular : HR = 0.82 ; 95 % CI = 0.58-1 .17 ; all-cause mortality : HR = 1.04 ; 95 % CI = 0.85-1 .27 ) .
CONCLUSIONS	Long-term presence of diabetes reduces survival .
CONCLUSIONS	Compared with thiazide diuretics , ACEI-based antihypertensives may delay the development of diabetes in those at risk and thus potentially improve cardiovascular outcome in the elderly .

###25027286
BACKGROUND	Obesity is associated with a risk of gastroesophageal reflux disease .
BACKGROUND	The pharmacodynamic efficacy of proton pump inhibitors has not been specifically evaluated in obese subjects .
BACKGROUND	The aim of this study was to compare the antisecretory response to a single oral dose of 20 mg rabeprazole , 20 mg omeprazole and placebo in obese subjects .
METHODS	Gastric pH was monitored for 24 hours on three separate occasions in eighteen H. pylori-negative , asymptomatic obese subjects .
METHODS	Subjects were given omeprazole , rabeprazole or placebo in a randomized order and in a double-blind fashion .
METHODS	The main analysis criterion was 24-h percent of time post dose with intragastric pH above 3 ; secondary criteria were percentage of time above pH 4 , median pH , [ H + ] concentrations and nocturnal acid breakthrough ( NAB ) .
METHODS	Results were analyzed using linear mixed models and Wilks test comparing variances .
RESULTS	24-h median [ IQ ] percentages of time with gastric pH above 3 and 4 were higher with rabeprazole than omeprazole ( 46 [ 37-55 ] vs. 30 [ 15-55 ] % , 9 [ 5-11 ] % for placebo ) but the differences did not reach statistical significance ( p = 0.11 and 0.24 , respectively ) .
RESULTS	Median acid concentrations were significantly lower with rabeprazole than with omeprazole and placebo ( 22 [ 14-53 ] vs. 54 [ 19-130 ] and 95 [ 73-170 ] mmoles/l , p < 0.01 ) for all periods .
RESULTS	The number of NAB was significantly lower with rabeprazole than with omeprazole ( median 1 [ 1,2 ] vs. 2 [ 1-3 ] , p = 0.04 ) .
RESULTS	Variances of 24-h data ( pH above 3 and 4 , median pH , [ H + ] concentrations ) were significantly lower with rabeprazole than with omeprazole ( p < 0.0001 ) .
CONCLUSIONS	In asymptomatic obese subjects the gastric antisecretory response to a single dose of rabeprazole and omeprazole was strong and not significantly different between drugs despite a significantly more homogeneous response with rabeprazole .
BACKGROUND	ClinicalTrial.gov : NCT01136317 .

###25439809
OBJECTIVE	To study the effect of growth hormone ( GH ) treatment on ovarian and uterine morphology and function in short , prepubertal small-for-gestational-age ( SGA ) girls .
METHODS	A multinational , randomized controlled trial on safety and efficacy of GH therapy in short , prepubertal children born SGA .
METHODS	Not applicable .
METHODS	A subgroup of 18 Danish girls born SGA included in North European SGA Study ( NESGAS ) .
METHODS	One year of GH treatment ( 67 g/kg/day ) followed by 2 years of randomized GH treatment ( 67 g/kg/day , 35 g/kg/day , or IGF-I titrated ) .
METHODS	Data on anthropometrics , reproductive hormones , and ultrasonographic examination of the internal genitalia were collected during 36 months of GH treatment .
RESULTS	Uterine and ovarian volume increased significantly during 3 years of treatment ( 64 % and 110 % , respectively ) but remained low within normal reference ranges .
RESULTS	Ovarian follicles became visible in 58 % after 1 year compared with 28 % before GH therapy .
RESULTS	Anti-Mllerian hormone increased significantly during the 3 years of GH therapy but remained within the normal range .
RESULTS	Precocious puberty was observed in one girl ; another girl developed multicystic ovaries .
CONCLUSIONS	GH treatment was associated with statistically significant growth of the internal genitalia , but remained within the normal range .
CONCLUSIONS	As altered pubertal development and ovarian morphology were found in 2 of 18 girls , monitoring of puberty and ovarian function during GH therapy in SGA girls is prudent .
CONCLUSIONS	Altogether , the findings are reassuring .
CONCLUSIONS	However , long-term effects of GH treatment on adult reproductive function remain unknown .
BACKGROUND	EudraCT 2005-001507-19 .

###24898858
OBJECTIVE	To test the hypothesis that a brief , clinic-based , single-session programme will reduce the rate of 10 selected condom use errors in a clinical sample of young black men ( YBM ) ages 15 through 23 years .
METHODS	Data were collected in clinics treating patients with sexually transmitted infections ( STI ) in three southern US cities .
METHODS	Males 15-23years of age who identified as black/African-American , and reported recent ( past 2months ) condom use were eligible .
METHODS	Only those also reporting condom use in the 2months prior to a 6-month follow-up assessment ( n = 311 ) were included in this secondary analysis of data from a randomised , controlled trial .
METHODS	Difference scores were used to capture a GroupTime effect .
RESULTS	YBM reported 2232 condom use events in the 2months preceding study enrolment and 2042 in the 2months preceding the follow-up assessment .
RESULTS	Mean baseline error rates were 1.32 and 1.13 for young men randomised to the intervention and control conditions , respectively .
RESULTS	Follow-up rates were 1.11 and 3.59 for young men randomised to the intervention and control conditions , respectively .
RESULTS	Controlled findings yielded a significant effect for the influence of group assignment on the difference score ( baseline to follow-up ) in the condom use error rate ( = 0.13 ; p = 0.02 ) .
CONCLUSIONS	A brief , clinic-based counselling programme produced modest reductions in condom use errors among YBM attending STI clinics in the southern USA Intensified clinic-based intervention that helps YBM improve the quality of their condom use behaviours is warranted .
BACKGROUND	NCT00849823 .

###24672940
OBJECTIVE	To provide evidence for Chinese medical treatment of children with EB virus infection by exploring its clinical efficacy from multiple angles .
METHODS	Totally 81 children patients were randomly assigned to the treatment group ( 46 cases ) and the control group ( 35 cases ) .
METHODS	Patients in the treatment group took Chinese medical decoction , while those in the control received intravenous dripping of Ganciclovir and oral administration of pidotimod .
METHODS	The treatment period for the two groups was 2 weeks .
METHODS	Patients were followed-up till the 12th week .
METHODS	Clinical symptoms such as fever , lymphadenopathy and hepatosplenomegaly , as well as lab indices such as abnormal lymphocyte percentage , EB virus antibody , virus DNA load , T cell subsets , immunoglobulin , and so on were observed before and after treatment , at week 4 and 12 of follow-ups .
RESULTS	( 1 ) The total effective rate at week 2 was 95.6 % in the treatment group , higher than that of the control group ( 94.3 % ) , but there was no statistical difference between the two groups .
RESULTS	( 2 ) The time for defervescence , duration of pharyngeal hyperemia , duration of swollen tonsils was shorter in the treatment group than in the control group ( P < 0.05 ) .
RESULTS	The subsidence of lymphadenopathy , hepatomegaly , and abnormal lymphocytes was better in the treatment group than in the control group ( P < 0.05 ) .
RESULTS	( 3 ) The positive cases of peripheral blood hetero-lymphocyte was significantly reduced after treatment , at week 4 and 12 of follow-ups both in the treatment group and the control group ( P < 0.01 ) .
RESULTS	The expression of IgA and IgM decreased after treatment in the two groups when compared with before treatment in the same group ( P < 0.05 , P < 0.01 ) .
RESULTS	IgG in the treatment group also obviously decreased after treatment , at week 4 and 12 of follow-ups ( P < 0.05 , P < 0.01 ) , while it decreased only after treatment in the control group ( P < 0.05 ) .
RESULTS	Activities of AST and ALT in the treatment group and the AST activity in the control group were markedly improved when compared with those before treatment ( P < 0.05 ) .
RESULTS	Compared with the control group , the abnormal lymphocyte positive case number obviously decreased in the treatment group after treatment , at week 4 and 12 of follow-ups ( P < 0.05 ) .
RESULTS	( 4 ) After treatment , at week 4 and 12 of follow-ups , CD3 + and CD8 + significantly decreased ; CD4 + , CD4/CD8 , and B cells significantly increased in the two groups , when compared with before treatment ( P < 0.05 ) .
RESULTS	NK cells significantly increased more in the treatment group after treatment , at week 4 and 12 of follow-ups , higher than before treatment as well as the control group ( P < 0.05 ) .
RESULTS	( 5 ) EB viral DNA and EB viral CA-IgM negative conversion case numbers significantly increased in the two groups after treatment , at week 4 and 12 of follow-ups ( P < 0.05 ) .
RESULTS	Compared with the control group , EB viral DNA and EB viral CA-IgM negative conversion case numbers significantly increased in the treatment group after treatment and at week 4 of follow-ups ( P < 0.05 ) .
CONCLUSIONS	Treatment of EB virus infection by Chinese medical treatment was effective .
CONCLUSIONS	It could promote the recovery of EB viral infection , and reduce the risk of vicious disease after EB viral infection .

###25039547
OBJECTIVE	The primary objective was to compare the cosmetic outcomes of traumatic trunk and extremity lacerations repaired using absorbable versus nonabsorbable sutures .
OBJECTIVE	The secondary objective was to compare complication rates between the two groups .
METHODS	This was a randomized controlled trial comparing wounds repaired with Vicryl Rapide and Prolene sutures .
METHODS	Pediatric and adult patients with lacerations were enrolled in the study .
METHODS	At a 10-day follow-up , the wounds were evaluated for infection and dehiscence .
METHODS	After 3 months , patients returned to have the wounds photographed .
METHODS	Two plastic surgeons blinded to the method of closure rated the cosmetic outcome of each wound using a 100-mm visual analog scale ( VAS ) .
METHODS	Using a noninferiority design , a VAS score of 13 mm or greater was considered to be a clinically significant difference .
METHODS	We used a Student 's t-test to compare differences between mean VAS scores and odds ratios ( ORs ) to compare differences in complication rates between the two groups .
RESULTS	Of the 115 patients enrolled , 73 completed the study including 35 in the Vicryl Rapide group and 38 in the Prolene group .
RESULTS	The mean ( SD ) age of patients who completed the study was 22.1 ( 15.5 ) years , and 39 were male .
RESULTS	We found no significant differences in the age , race , sex , length of wound , number of sutures , or layers of repair in the two groups .
RESULTS	The observer 's mean VAS for the Vicryl Rapide group was 54.1 mm ( 95 % confidence interval [ CI ] = 44.5 to 67.0 mm ) and for the Prolene group was 54.5 mm ( 95 % CI = 45.7 to 66.3 mm ) .
RESULTS	The resulting mean difference was 0.5 mm ( 95 % CI = -12.1 to 17.2 mm ; p = 0.9 ) ; thus noninferiority was established .
RESULTS	Statistical testing showed no differences in the rates of complications between the two groups , but a higher percentage of the Vicryl Rapide wounds developed complications .
CONCLUSIONS	The use of absorbable sutures for the repair of simple lacerations on the trunk and extremities should be considered as an alternative to nonabsorbable suture repair .

###25139873
OBJECTIVE	Aspirin early after intravenous thrombolysis in acute ischemic stroke increases the risk of symptomatic intracranial hemorrhage ( SICH ) , without influencing functional outcome at 3 months .
OBJECTIVE	The effect of aspirin on early neurological deterioration ( END ) was explored as a post hoc analysis of the randomized Antiplatelet Therapy in Combination With Recombinant t-PA Thrombolysis in Ischemic Stroke ( ARTIS ) trial .
METHODS	END , defined as a 4 points National Institutes of Health Stroke Scale worsening 24 hours after intravenous thrombolysis , was categorized into SICH ( ENDSICH ) and cerebral ischemia ( ENDCI ) .
METHODS	Multinomial logistic regression was used to assess the effect of aspirin on END .
RESULTS	Of the 640 patients , 31 patients ( 4.8 % ) experienced END ( 14 ENDSICH , 17 ENDCI ) .
RESULTS	Aspirin increased the risk of ENDSICH ( odds ratio , 3.73 ; 95 % confidence interval , 1.03-13 .49 ) but not of ENDCI ( odds ratio , 1.14 ; 95 % confidence interval , 0.44-3 .00 ) .
RESULTS	After adjustment for other explanatory variables , the association between aspirin and ENDSICH remained significant .
CONCLUSIONS	In this trial , there is no evidence of an early antithrombotic effect from the addition of aspirin to intravenous thrombolysis in acute ischemic stroke .

###24917273
OBJECTIVE	To compare the relative effectiveness of methotrexate and mycophenolate mofetil for noninfectious intermediate uveitis , posterior uveitis , or panuveitis .
METHODS	Multicenter , block-randomized , observer-masked clinical trial .
METHODS	Eighty patients with noninfectious intermediate , posterior , or panuveitis requiring corticosteroid-sparing therapy at Aravind Eye Hospitals in Madurai and Coimbatore , India .
METHODS	Patients were randomized to receive 25 mg weekly oral methotrexate or 1 g twice daily oral mycophenolate mofetil and were monitored monthly for 6 months .
METHODS	Oral prednisone and topical corticosteroids were tapered .
METHODS	Masked examiners assessed the primary outcome of treatment success , defined by achieving the following at 5 and 6 months : ( 1 ) 0.5 + anterior chamber cells , 0.5 + vitreous cells , 0.5 + vitreous haze and no active retinal/choroidal lesions in both eyes , ( 2 ) 10 mg of prednisone and 2 drops of prednisolone acetate 1 % a day , and ( 3 ) no declaration of treatment failure because of intolerability or safety .
METHODS	Additional outcomes included time to sustained corticosteroid-sparing control of inflammation , change in best spectacle-corrected visual acuity , resolution of macular edema , adverse events , subgroup analysis by anatomic location , and medication adherence .
RESULTS	Forty-one patients were randomized to methotrexate and 39 to mycophenolate mofetil .
RESULTS	A total of 67 patients ( 35 methotrexate , 32 mycophenolate mofetil ) contributed to the primary outcome .
RESULTS	Sixty-nine percent of patients achieved treatment success with methotrexate and 47 % with mycophenolate mofetil ( P = 0.09 ) .
RESULTS	Treatment failure from adverse events or tolerability was not different by treatment arm ( P = 0.99 ) .
RESULTS	There were no differences between treatment groups in time to corticosteroid-sparing control of inflammation ( P = 0.44 ) , change in best spectacle-corrected visual acuity ( P = 0.68 ) , or resolution of macular edema ( P = 0.31 ) .
CONCLUSIONS	There was no statistically significant difference in corticosteroid-sparing control of inflammation between patients receiving methotrexate or mycophenolate mofetil .
CONCLUSIONS	However , there was a 22 % difference in treatment success favoring methotrexate .

###24925006
BACKGROUND	The prevalence of methicillin-resistant Staphylococcus aureus ( MRSA ) respiratory infection in cystic fibrosis ( CF ) has increased dramatically over the last decade , and is now affecting approximately 25 % of patients .
BACKGROUND	Epidemiologic evidence suggests that persistent infection with MRSA results in an increased rate of decline in FEV1 and shortened survival .
BACKGROUND	Currently , there are no conclusive studies demonstrating an effective and safe treatment protocol for persistent MRSA respiratory infection in CF.
METHODS	The primary objective of this study is to evaluate the safety and efficacy of a 28-day course of vancomycin for inhalation in combination with oral antibiotics in eliminating MRSA from the respiratory tract of individuals with CF and persistent MRSA infection .
METHODS	This is a two-center , randomized , double-blind , comparator-controlled , parallel-group study with 1:1 assignment to either vancomycin for inhalation ( 250mg twice a day ) or taste-matched placebo for 28days in individuals with cystic fibrosis .
METHODS	In addition , both groups will receive oral rifampin , a second oral antibiotic - trimethoprim/sulfamethoxazole ( TMP/SMX ) or doxycycline , protocol determined - mupirocin intranasal cream , and chlorhexidine body washes .
METHODS	Forty patients with persistent respiratory tract MRSA infection will be enrolled : 20 will be randomized to vancomycin for inhalation and 20 to a taste-matched placebo .
METHODS	The primary outcome will be the presence of MRSA in sputum respiratory tract cultures 1month after the conclusion of treatment .
METHODS	Secondary outcomes include the efficacy of the intervention on : FEV1 % predicted , patient reported outcomes , pulmonary exacerbations , and MRSA colony-forming units found in respiratory tract sample culture .
CONCLUSIONS	Results of this study will provide guidance to clinicians regarding the safety and effectiveness of a targeted eradication strategy for persistent MRSA infection in CF.
BACKGROUND	This trial is registered at ClinicalTrials.gov ( NCT01594827 , received 05/07/2012 ) and is funded by the Cystic Fibrosis Foundation ( Grants : PMEP10K1 and PMEP11K1 ) .

###24559194
BACKGROUND	There is a strong association between weight gain and metabolic events in patients with schizophrenia receiving many of the second-generation antipsychotic agents .
BACKGROUND	We explored the relationship between body mass index ( BMI ) and metabolic events in patients with schizophrenia receiving long-acting injectable paliperidone palmitate ( PP ) in a long-term trial .
METHODS	We conducted a post hoc analysis of data from a PP study that included a 33-week open-label transition ( TR ) and maintenance phase ; a variable duration , randomized , double-blind ( DB ) , placebo-controlled phase and a 52-week open-label extension ( OLE ) phase .
METHODS	Overall , 644 patients received PP continuously from study entry through discontinuation or study completion and were grouped by baseline BMI ( kg/m2 ) : underweight ( BMI < 19 ; n = 29 , 4.5 % ) , normal-weight ( BMI 19 - < 25 ; n = 229 , 35.6 % ) , overweight ( BMI 25 - < 30 ; n = 232 , 36.0 % ) and obese ( BMI 30 ; n = 154 , 23.9 % ) .
METHODS	Metabolic treatment-emergent adverse events ( TEAEs ) and changes in related laboratory results from TR baseline were analyzed .
RESULTS	PP exposure was similar across BMI groups ; overall mean ( SD ) dose/month was 70.3 ( 17.17 ) mg eq .
RESULTS	[ 109.6 ( 26.78 ) mg ] ; median duration of exposure was 204 days ( 6 to 1009 days ) .
RESULTS	Occurrences of metabolic TEAEs overall by group were 0 % ( underweight ) , 14.9 % ( normal-weight ) , 14.7 % ( overweight ) , and 24.0 % ( obese ) .
RESULTS	The most common ( 2 % ) metabolic TEAE were weight gain and elevated blood levels of glucose , lipids , and insulin .
RESULTS	Mean BMI and weight increased in normal-weight and overweight groups at DB endpoint , and in underweight , normal-weight and overweight groups at OLE endpoint ( p 0.05 ) .
RESULTS	No consistent trend for increased metabolic-related laboratory values by baseline BMI group was observed .
RESULTS	Homeostatic model assessments for insulin resistance indicated preexisting insulin resistance at baseline , with minimal changes at OLE endpoint across baseline BMI groups .
CONCLUSIONS	Occurrences of metabolic-related TEAEs trended with greater BMI status in patients with schizophrenia treated with PP ; consistent trends in metabolic-related laboratory values were not observed .
BACKGROUND	This study is registered at ClinicalTrials.gov ( NCT 00518323 ) .

###25203483
BACKGROUND	Fecal immunochemical tests ( FITs ) are recommended to screen average-risk adults for colorectal cancer ( CRC ) .
BACKGROUND	Little research has examined whether a two-sample FIT affects participant uptake , compared with a one-sample FIT .
BACKGROUND	Examining participant uptake is important , as evidence suggests that a two-sample FIT may increase the sensitivity to detect CRC .
OBJECTIVE	This study had two objectives : ( i ) to evaluate FIT completion in a population that received either a one-sample FIT kit ( 1-FIT ) or a two-sample FIT kit ( 2-FIT ) and ( ii ) to understand whether uptake varies by age , sex , or receipt of prior CRC screening .
METHODS	We conducted a randomized controlled trial in which 3081 participants who were aged between 50 and 75 years and were at an average risk for CRC , and who had requested FITs , randomly received 1-FIT ( n = 1540 ) or 2-FIT ( n = 1541 ) kits .
METHODS	FIT completion was defined as the completion and return of a one-sample test by the patients in the 1-FIT group or of both sample tests by those in the 2-FIT group .
METHODS	Cox proportional hazard regression models were used to determine the independent effect of group type ( 2-FIT vs. 1-FIT ) on the completion of the FIT , adjusting for age , sex , and receipt of prior CRC screening .
RESULTS	The 2-FIT group had lower test completion rates ( hazard ratio = 0.87 ; 95 % confidence interval = 0.78-0 .97 ; P = 0.01 ) after adjusting for age , sex , and receipt of prior CRC screening .
RESULTS	Participant uptake did not vary by age , sex , or receipt of prior CRC screening .
CONCLUSIONS	This unique , rigorous randomized controlled trial found that the 2-FIT regimen decreases completion of FIT .
CONCLUSIONS	Further research is needed to understand whether decreases in participant uptake are offset by increased gains in test sensitivity .

###25227656
OBJECTIVE	Evaluation of the safety and efficacy of pazopanib , a multikinase angiogenesis inhibitor , in a single-arm , open-label , extension study ( VEG107769/NCT00387764 ) for placebo-treated patients with advanced renal cell carcinoma ( RCC ) from a randomized , double-blind , placebo-controlled phase III study ( VEG105192/NCT00334282 ) .
METHODS	Patients received pazopanib 800 mg/day .
METHODS	The primary endpoint was the safety and tolerability of pazopanib treatment .
METHODS	Secondary endpoints included response rate per Response Evaluation Criteria in Solid Tumors , progression-free survival ( PFS ) , and overall survival ( OS ) .
RESULTS	Seventy-nine placebo-treated patients from VEG105192/NCT00334282 who experienced disease progression and one pazopanib-treated patient ( an exemption ) were enrolled .
RESULTS	Forty-one patients ( 51 % ) were treatment-naive ; 39 ( 49 % ) were cytokine-pretreated .
RESULTS	Median exposure to pazopanib was 9.7 months .
RESULTS	All patients had discontinued pazopanib at the time of analysis .
RESULTS	The most common reason for discontinuation was disease progression ( 61 % ) .
RESULTS	The most common adverse events were hypertension ( 45 % ) , diarrhea ( 45 % ) , hair color changes ( 44 % ) , anorexia ( 30 % ) , and nausea ( 25 % ) .
RESULTS	The response rate was 37.5 % [ 95 % confidence interval ( CI ) : 26.9-48 .1 ] ; median PFS was 9.2 months ( 95 % CI : 7.3-12 .0 ) ; median OS was 23.5 months ( 95 % CI : 16.3-28 .0 ) .
CONCLUSIONS	Efficacy and safety profiles for pazopanib in this extension study of patients with RCC previously treated with placebo were very similar to those observed for pazopanib-treated patients in the pivotal phase III study .

###24831979
BACKGROUND	An established multivariate serum protein test can be used to classify patients according to whether they are likely to have a good or poor outcome after treatment with EGFR tyrosine-kinase inhibitors .
BACKGROUND	We assessed the predictive power of this test in the comparison of erlotinib and chemotherapy in patients with non-small-cell lung cancer .
METHODS	From Feb 26 , 2008 , to April 11 , 2012 , patients ( aged 18 years ) with histologically or cytologically confirmed , second-line , stage IIIB or IV non-small-cell lung cancer were enrolled in 14 centres in Italy .
METHODS	Patients were stratified according to a minimisation algorithm by Eastern Cooperative Oncology Group performance status , smoking history , centre , and masked pretreatment serum protein test classification , and randomly assigned centrally in a 1:1 ratio to receive erlotinib ( 150 mg/day , orally ) or chemotherapy ( pemetrexed 500 mg/m ( 2 ) , intravenously , every 21 days , or docetaxel 75 mg/m ( 2 ) , intravenously , every 21 days ) .
METHODS	The proteomic test classification was masked for patients and investigators who gave treatments , and treatment allocation was masked for investigators who generated the proteomic classification .
METHODS	The primary endpoint was overall survival and the primary hypothesis was the existence of a significant interaction between the serum protein test classification and treatment .
METHODS	Analyses were done on the per-protocol population .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00989690 .
RESULTS	142 patients were randomly assigned to chemotherapy and 143 to erlotinib , and 129 ( 91 % ) and 134 ( 94 % ) , respectively , were included in the per-protocol analysis .
RESULTS	88 ( 68 % ) patients in the chemotherapy group and 96 ( 72 % ) in the erlotinib group had a proteomic test classification of good .
RESULTS	Median overall survival was 90 months ( 95 % CI 68-109 ) in the chemotherapy group and 77 months ( 59-104 ) in the erlotinib group .
RESULTS	We noted a significant interaction between treatment and proteomic classification ( pinteraction = 0017 when adjusted for stratification factors ; pinteraction = 0031 when unadjusted for stratification factors ) .
RESULTS	Patients with a proteomic test classification of poor had worse survival on erlotinib than on chemotherapy ( hazard ratio 172 [ 95 % CI 108-274 ] , p = 0022 ) .
RESULTS	There was no significant difference in overall survival between treatments for patients with a proteomic test classification of good ( adjusted HR 106 [ 077-146 ] , p = 0714 ) .
RESULTS	In the group of patients who received chemotherapy , the most common grade 3 or 4 toxic effect was neutropenia ( 19 [ 15 % ] vs one [ < 1 % ] in the erlotinib group ) , whereas skin toxicity ( one [ < 1 % ] vs 22 [ 16 % ] ) was the most frequent in the erlotinib group .
CONCLUSIONS	Our findings indicate that serum protein test status is predictive of differential benefit in overall survival for erlotinib versus chemotherapy in the second-line setting .
CONCLUSIONS	Patients classified as likely to have a poor outcome have better outcomes on chemotherapy than on erlotinib .
BACKGROUND	Italian Ministry of Health , Italian Association of Cancer Research , and Biodesix .

###25137430
OBJECTIVE	This study was to evaluate the effect of intraoperative continuous infusion of dexmedetomidine on intraocular pressure ( IOP ) in patients undergoing robot-assisted laparoscopic radical prostatectomy ( RALRP ) in the steep Trendelenburg ( ST ) .
METHODS	Sixty-eight patients were randomly divided into two groups .
METHODS	The dexmedetomidine group ( Group D , n = 34 ) received a continuous infusion of dexmedetomidine at a rate of 0.4 g kg ( -1 ) hour ( -1 ) from the induction of anesthesia until the end of the ST position , while the control group ( Group C , n = 34 ) received an equal volume of physiologic saline at the same rate under conventional general anesthesia with sevoflurane and remifentanil .
METHODS	IOP was measured at 11 predefined time points for all patients .
RESULTS	Significant differences in IOP were detected between the two groups by a linear mixed model analysis ( p < 0.001 ) .
RESULTS	The highest mean IOP was 19.95.0 mm Hg in Group D and 25.75.0 mm Hg in Group C ; both were measured 60 minutes after the patients had been placed in the ST position .
RESULTS	No significant between-group differences in ocular perfusion pressure , mean blood pressure , or heart rate were observed between the two groups .
RESULTS	No ocular or other complications were noted .
CONCLUSIONS	Intraoperative continuous infusion of dexmedetomidine may help alleviate IOP increase in patients undergoing RALRP in the ST position .

###25514543
OBJECTIVE	Disruptive or challenging behavior problems pose a threat to children and adolescents with intellectual disabilities and their caregivers .
OBJECTIVE	Psychopharmacological treatment is mostly studied with new-generation antipsychotics and has been criticized for adverse side effects .
OBJECTIVE	This study examined the effect of the classic antipsychotic zuclopenthixol .
METHODS	A total of 39 boys ( ages 8.0-17 .11 years ) with learning disabilities were included and examined for a response to zuclopenthixol during a 6 week period of open label treatment .
METHODS	Doses started low and were adapted individually .
METHODS	From responders , zuclopenthixol was randomly withdrawn for 12 weeks .
METHODS	Responses to withdrawal were observed by external raters using the Modified Overt Aggression Scale .
RESULTS	Of all patients included into the study , 15 were not randomized because of insufficient therapeutic effect , adverse event , or noncompliance .
RESULTS	Kaplan-Meier estimations showed less aggressive behavior problems for the continuing subgroup ( n = 9 ) than in the placebo group ( n = 15 ) .
RESULTS	Individual doses stayed < 10mg/day .
CONCLUSIONS	Zuclopenthixol proved to be effective in reducing challenging behavior in boys even at low doses .

###25925990
OBJECTIVE	The purpose of this multicenter , open label , randomized phase III study was to determine whether ixabepilone resulted in improved overall survival ( OS ) compared with commonly used single-agent chemotherapy ( doxorubicin or paclitaxel ) in women with locally advanced , recurrent , or metastatic endometrial cancer with at least one failed prior platinum-based chemotherapeutic regimen .
METHODS	Patients were randomized 1:1 to ixabepilone ( 40mg/m ( 2 ) ) , or either paclitaxel ( 175mg/m ( 2 ) ) or doxorubicin ( 60mg/m ( 2 ) ) , every 21days .
METHODS	Patients that had previously received an anthracycline were randomized to ixabepilone or paclitaxel ; all other patients were randomized to ixabepilone or doxorubicin .
METHODS	An interim analysis of futility for OS was planned .
RESULTS	At the time of database lock , 496 patients were randomized to receive ixabepilone ( n = 248 ) or control ( n = 248 ) ; nine patients in the control arm were not treated .
RESULTS	The interim analysis of futility for OS ( 219 events ) favored the control chemotherapy arm ( hazard ratio = 1.3 [ 95 % confidence interval : 1.0-1 .7 ] , stratified log rank test P = 0.0397 ) , indicating that the study would not meet its primary objective .
RESULTS	The study was discontinued based on the interim OS results .
RESULTS	The frequency of adverse events was comparable between the treatment arms .
CONCLUSIONS	The study did not meet its primary objective of improving OS in the ixabepilone arm compared to the control chemotherapy arm .
CONCLUSIONS	A favorable risk/benefit ratio was not observed for ixabepilone versus control at the time of the interim analysis .
CONCLUSIONS	The safety results were consistent with the known safety profiles of ixabepilone and control .

###25252480
OBJECTIVE	To determine the impact of calcium and phosphorus on radiological and biochemical characteristics of osteopenia in premature infants .
METHODS	The randomised clinical trial study was conducted at Valie-e-Asr Hospital of Zanjan city , Iran , from December 2010 to June 2011 .
METHODS	It involved monitoring 40 premature neonates over a period of six months .
METHODS	The babies , who were fed with breast milk and 400 units of vitamin D daily , were randomly divided into two equal groups .
METHODS	One group received supplement of calcium and phosphorus .
METHODS	Serum calcium , phosphorus and alkaline phosphatase levels as well as growth parameters ( including weight , height , and head circumference ) were measured every two weeks .
METHODS	At the end of the study , wrist X-ray was done for evaluation of osteopenia .
METHODS	Data was analysed using SPSS 16 .
RESULTS	Radiological changes , characteristic of osteopenia , were found in 8 ( 40 % ) cases and 13 ( 65 % ) controls ( p < 0.113 ) .
RESULTS	The mean of weight , length and head circumference increased significantly from second to sixth week during follow-up ( p < 0.0001 ) .
RESULTS	Phosphorus and alkaline phosphatase activity decreased significantly from second to sixth week of follow-up ( p < 0.02 , p < 0.01 respectively ) .
RESULTS	However , repeated measurement analyses did not show significant effect of intervention in biochemical and growth parameters in the trial group .
CONCLUSIONS	The study did n't show significant effect of calcium and phosphorus on prevention of osteopenia and improvement of growth .
CONCLUSIONS	Further studies of longer duration and with different doses of supplement are recommended .

###24720919
OBJECTIVE	The purpose of this study was to test the efficacy of a 6-month course of anti-inflammatory treatment with colchicinein improving functional status of patients with stable chronic heart failure ( CHF ) .
BACKGROUND	CHF has been shown to be associated with inflammatory activation .
BACKGROUND	Inflammation has been designated as a therapeutic target in CHF .
METHODS	Patients with stable CHF were randomly assigned to colchicine ( 0.5 mg twice daily ) or placebo for 6 months .
METHODS	Theprimary endpoint was the proportion of patients achieving at least one-grade improvement in New York HeartAssociation class .
RESULTS	Two hundred sixty-seven patients were available for final evaluation of the primary endpoint : its rate was 11 % in the control group and 14 % in the colchicine group ( odds ratio : 1.40 ; 95 % confidence interval : 0.67 to 2.93 ; p = 0.365 ) .
RESULTS	The rate of the composite of death or hospital stay for heart failure was 9.4 % in the control group , compared with 10.1 % in the colchicine group ( p = 0.839 ) .
RESULTS	The changes in treadmill exercise time with treatment were insignificant and similar in the 2 groups ( p = 0.938 ) .
RESULTS	C-reactive protein and interleukin-6 were both significantly reduced in the colchicine group ( -5.1 mg/l and -4.8 pg/ml , respectively ; p < 0.001 for both , compared with the control group ) .
CONCLUSIONS	According to this prospective , randomized study , anti-inflammatory treatment with colchicine in patients with stable CHF , although effective in reducing inflammation biomarker levels , did not affect in any significant way patient functional status ( in terms of New York Heart Association class and objective treadmill exercise tolerance ) or the likelihood of death or hospital stay for heart failure .

###24500245
OBJECTIVE	To examine the comparative antidepressant efficacy of S-adenosyl-L-methionine ( SAMe ) and escitalopram in a placebo-controlled , randomized , double-blind clinical trial .
METHODS	One hundred eighty-nine outpatients ( 49.7 % female , mean [ SD ] age = 45 [ 15 ] years ) with DSM-IV-diagnosed major depressive disorder ( MDD ) were recruited from April 13 , 2005 , to December 22 , 2009 , at the Massachusetts General Hospital and at Butler Hospital .
METHODS	Patients were randomized for 12 weeks to SAMe 1,600-3 ,200 mg/d , escitalopram 10-20 mg/d , or placebo .
METHODS	Doses were escalated at 6 weeks in the event of nonresponse .
METHODS	The main outcome measure was the 17-item Hamilton Depression Rating Scale ( HDRS-17 ) .
METHODS	Tolerability was assessed by the Systematic Assessment for Treatment of Emergent Events-Specific Inquiry ( SAFTEE-SI ) .
RESULTS	All 3 treatment arms demonstrated a significant improvement of about 5-6 points in HDRS-17 scores ( P < .001 for all ) , and no significant differences were observed between the treatment arms ( P > .05 for all ) .
RESULTS	Response rates in the intent-to-treat sample were 36 % for SAMe , 34 % for escitalopram , and 30 % for placebo .
RESULTS	Remission rates were 28 % for SAMe , 28 % for escitalopram , and 17 % for placebo .
RESULTS	No comparisons between treatment groups attained significance ( P > .05 for all ) .
RESULTS	Tolerability was good , with gastrointestinal side effects ( 19 % for stomach discomfort and 20 % for diarrhea ) as the most common in the SAMe arm .
RESULTS	Significant differences were observed between treatment groups for dizziness , anorgasmia , diminished mental acuity , and hot flashes ( P < .05 for all ) .
CONCLUSIONS	The results fail to support an advantage over placebo for either the investigational treatment SAMe or the standard treatment escitalopram for MDD .
BACKGROUND	ClinicalTrials.gov identifier : NCT00101452 .

###25833772
BACKGROUND	Total weight loss induced by energy restriction is highly variable even under tightly controlled conditions .
BACKGROUND	Identifying weight-loss discriminants would provide a valuable weight management tool and insights into body weight regulation .
OBJECTIVE	This study characterized responsiveness to energy restriction in adults from variables including the plasma metabolome , endocrine and inflammatory markers , clinical indices , body composition , diet , and physical activity .
METHODS	Data were derived from a controlled feeding trial investigating the effect of 3-4 dairy product servings in an energy-restricted diet ( 2092 kJ/d reduction ) over 12 wk .
METHODS	Partial least squares regression was used to identify weight-loss discriminants in 67 overweight and obese adults .
METHODS	Linear mixed models were developed to identify discriminant variable differences in high - vs. low-weight-loss responders .
RESULTS	Both pre - and postintervention variables ( n = 127 ) were identified as weight-loss discriminants ( root mean squared error of prediction = 1.85 kg ; Q ( 2 ) = 0.43 ) .
RESULTS	Compared with low-responders ( LR ) , high-responders ( HR ) had greater decreases in body weight ( LR : 2.7 1.6 kg ; HR : 9.4 1.8 kg , P < 0.01 ) , BMI ( in kg/m ( 2 ) ; LR : 1.0 0.6 ; HR : 3.3 0.5 , P < 0.01 ) , and total fat ( LR : 2.2 1.1 kg ; HR : 8.0 2.1 kg , P < 0.01 ) .
RESULTS	Significant group effects unaffected by the intervention were determined for the respiratory exchange ratio ( LR : 0.86 0.05 ; HR : 0.82 0.03 , P < 0.01 ) , moderate physical activity ( LR : 127 52 min ; HR : 167 68 min , P = 0.02 ) , sedentary activity ( LR : 1090 99 min ; HR : 1017 110 min , P = 0.02 ) , and plasma stearate [ LR : 102,000 21,000 quantifier ion peak height ( QIPH ) ; HR : 116,000 24,000 QIPH , P = 0.01 ] .
CONCLUSIONS	Overweight and obese individuals highly responsive to energy restriction had accelerated reductions in adiposity , likely supported in part by higher lipid mobilization and combustion .
CONCLUSIONS	A novel observation was that person-to-person differences in habitual physical activity and magnitude of weight loss were accompanied by unique blood metabolite signatures .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT00858312 .

###24846454
BACKGROUND	Endovascular repair of abdominal aortic aneurysm ( AAA ) has recently been made a class I indication in the treatment of AAA .
BACKGROUND	In comparison to the conventional open surgical treatment , endovascular AAA repair ( EVAR ) is associated with equivalent long-term morbidity and mortality rates .
BACKGROUND	Vascular surgeons perform majority of EVAR .
BACKGROUND	There are no reports for the long-term results of this intervention performed by interventional cardiologists .
BACKGROUND	We present one of the first reports of periprocedural and long-term outcomes of EVAR performed by interventional cardiologists .
METHODS	Retrospective chart review on patients with attempted EVAR between September 2005 and January 2011 was performed .
METHODS	Included cases were all consecutive patients who had attempted EVAR by interventional cardiologists .
RESULTS	During the study period EVAR was attempted in 170 patients , with 27 % being women .
RESULTS	The mean age was 74 years ( range 52-93 ) .
RESULTS	The endovascular graft placement was successful in 96 % ( 163/170 ) of patients .
RESULTS	Procedure failures were more common in women ( 6 of 46 vs 1 of 124 , P = 0.003 ) .
RESULTS	The 30-day mortality was 1.8 % ( 3 of 170 ) .
RESULTS	In patients with successful EVAR the mean follow-up was 30 months and mean length of hospital stay was 3.53.2 days .
RESULTS	Major periprocedural complications were noted in 9 % patients ( 15 of 167 ) .
RESULTS	During follow-up , six patients ( 3.5 % ) required re-intervention and additional 16 patients died with no aneurysm related deaths .
CONCLUSIONS	EVAR primarily performed by interventional cardiologists demonstrates high periprocedural and long-term success rates .
CONCLUSIONS	A higher EVAR failure rate has been observed in women .

###24488838
OBJECTIVE	Anorexia nervosa ( AN ) is a severe illness with high rates of relapse .
OBJECTIVE	Exposure and Response Prevention for AN ( AN-EXRP ) is a new approach that specifically addresses maladaptive eating behavior by targeting eating-related fear and anxiety .
OBJECTIVE	The aim of this study was to evaluate AN-EXRP as an adjunctive strategy to improve eating behavior during weight restoration , at a pivotal moment when treatment goals shift toward relapse prevention .
METHODS	A randomized controlled trial was conducted to compare AN-EXRP with a comparison condition , Cognitive Remediation Therapy ( CRT ) .
METHODS	Hospitalized patients with AN ( n = 32 ) who had achieved weight restoration to a BMI > 18.5 kg/m ( 2 ) received 12 sessions of either AN-EXRP or CRT .
METHODS	Outcome was assessed by change in caloric intake in an objective assessment of eating behavior .
RESULTS	The average test meal caloric intake of participants who received AN-EXRP increased from 352263 kcal at baseline to 401215 kcal post-treatment , while that of participants who received CRT decreased from 501232 kcal at baseline to 424221 kcal post-treatment [ t ( 28 ) = 2.5 , p = .02 ] .
RESULTS	Improvement in intake was significantly associated with improvement in eating-related anxiety ( Spearman 's = 0.40 , p = .03 ) .
CONCLUSIONS	These data demonstrate that AN-EXRP , compared to a credible comparison intervention , is associated with better caloric intake in a laboratory meal over time in AN .
CONCLUSIONS	Additional studies are required to determine whether incorporation of these techniques into a longer treatment program leads to enduring and clinically significant change .

###25007421
OBJECTIVE	Aggressive behaviour in psychosis is not uncommon .
OBJECTIVE	Community provision for people with psychosis has left informal caregivers to take on a greater role in their care .
OBJECTIVE	However , few studies have explored links between patient-initiated violence in mental health caregiving relationships and caregiver functioning .
OBJECTIVE	Our study investigated caregiver reports of aggressive acts committed by their relative with psychosis and their links to caregiver appraisals of the caregiving relationship and caregiver outcomes .
METHODS	Caregivers of patients with a recent relapse of psychosis , recruited to a psychological therapy trial , completed the audiotaped Camberwell Family Interview at baseline .
METHODS	This semi-structured interview includes questions on the quality of the relationship between caregiver and patient , and patient history of violence .
METHODS	Seventy-two transcripts of interviews were assessed for reports of patient-initiated violence .
RESULTS	One-half of the caregiver sample ( 52.9 % ) reported an incident of patient-initiated violence during their interview ; 62.2 % of these involved violence toward themselves , and 24.3 % toward property .
RESULTS	Reports of patient violence were associated with caregiver ratings of hostility expressed toward patients , lower self-esteem , and emotion-focused coping .
RESULTS	People caring on their own were more likely to report incidents of patient violence .
RESULTS	Younger patients , males , and inpatients were more frequently identified as having a history of this kind of violence .
CONCLUSIONS	Our findings suggested that caregiver reports of patient-initiated violence in psychosis are not uncommon .
CONCLUSIONS	Mental health staff need to be aware of the risks of such violence for caregivers of people with psychosis , and consider appropriate procedures for minimizing it .

###24958362
BACKGROUND	Positive-pressure ventilation during transport of intubated patients is generally delivered via a hand-pressurized device .
BACKGROUND	Of these devices , self-inflating resuscitators ( SIR ) and flow-inflating resuscitators ( FIR ) constitute the two major types used .
BACKGROUND	Selection of a particular device for transport , however , remains largely an institutional practice .
OBJECTIVE	To evaluate the hypothesis that transport ventilation goals of intubated pediatric patients are better achieved using an FIR compared to an SIR .
METHODS	This randomized crossover simulation study compared the performance of SIR and FIR among anesthesia providers in a pediatric transport scenario .
METHODS	Subjects hand-ventilated a test lung while simultaneously maneuvering a stretcher bed to simulate patient transport .
METHODS	Hand ventilation was carried out using a Jackson-Rees circuit ( FIR ) and a Laerdal pediatric silicone resuscitator ( SIR ) .
METHODS	The primary outcome was the proportion of total breaths delivered within the predefined target PIP/PEEP range ( 30 + / - 3 , 10 + / - 3 cm H2O ) .
METHODS	Secondary outcomes included proportion of total breaths delivered with operationally defined unacceptable breath variables ( PIP > 35 cm H2O or PEEP < 5 cm H2O ) .
RESULTS	Overall , participants were four times more likely to deliver target breaths and one-third less likely to deliver unacceptable breaths using the FIR compared to the SIR .
RESULTS	When comparing device performance , a 44 % increase in the proportions of target breaths and a 40.4 % decrease in unacceptable breaths using the FIR were observed ( P < 0.0001 for both ) .
CONCLUSIONS	Hand ventilation during patient transport is superior using the FIR compared to the SIR to achieve target ventilatory goals and avoid unacceptable ventilatory cycles .

###25446547
OBJECTIVE	To examine efficacy of hysteroscopic removal of polyps and myomas on health-related quality of life and symptom severity at 1-year postprocedure .
METHODS	Randomized , prospective , comparative setting clinical trial ( Canadian Task Force classification II-2 ) .
METHODS	Nine outpatient obstetrics and gynecology practices and hospitals in the United States .
METHODS	Women 18 to 55years of age with polyps and/or type 0 or I myomas 1.5 and 3.0 cm .
METHODS	Treatment of polyps and fibroids with the MyoSure device .
RESULTS	A total of 118 lesions ( 76 polyps , 42 myomas ) were removed .
RESULTS	Among the 118 pathologies removed , 53 were removed in an office setting ( 28 myomas , 25 polyps ) , and 55 were removed in an ambulatory surgical center ( ASC ) setting ( 14 myomas , 41 polyps ) .
RESULTS	The mean percentage of pathology removed was 95.96.8 % for fibroids and 99.9 0.7 % for polyps .
RESULTS	Symptom severity as measured by the Uterine Fibroid Symptom-Quality of Life ( UFS-QOL ) scale improved significantly ( p < .01 ) between baseline ( mean score of 67.515.4 ) and 12months postprocedure ( mean score of 22.322.6 ) .
RESULTS	The Health-Related Quality of Life ( HRQOL ) scale also improved significantly ( p < .01 ) between baseline ( mean score 38.723.3 ) and 12months postprocedure ( mean score of 83.924.4 ) .
RESULTS	Both the office and ASC groups demonstrated a statistically significant ( p < .01 ) improvement in UFS-QOL and HRQOL .
CONCLUSIONS	For women with intrauterine polyps and/or myomas who experienced abnormal uterine bleeding , hysteroscopic morcellation with the MyoSure device provided significant , durable health-related , quality-of-life improvements up to 12months postprocedure .
CONCLUSIONS	These findings were the same for patients treated in both an office-based setting and ASCs .

###24530651
OBJECTIVE	To evaluate the effects of a home-monitoring device with tele-monitoring compared with standard care in detection of progression to choroidal neovascularization ( CNV ) associated with age-related macular degeneration ( AMD ) , the leading cause of blindness in the US .
METHODS	Participants , aged 55 to 90 years , at high risk of developing CNV associated with AMD were recruited to the HOme Monitoring of Eye ( HOME ) Study , an unmasked , multi-center , randomized trial of the ForeseeHome ( FH ) device plus standard care vs. standard care alone .
METHODS	The FH device utilizes preferential hyperacuity perimetry and tele-monitoring to detect changes in vision function associated with development of CNV , potentially prior to symptom and visual acuity loss .
METHODS	After establishing baseline measurements , subsequent changes on follow-up are detected by the device , causing the monitoring center to alert the clinical center to recall participants for an exam .
METHODS	Standard care consists of instructions for self-monitoring visual changes with subsequent self-report to the clinical center .
METHODS	The primary objective of this study is to determine whether home monitoring plus standard care in comparison with standard care alone , results in earlier detection of incident CNV with better present visual acuity .
METHODS	The primary outcome is the decline in visual acuity at CNV diagnosis from baseline .
METHODS	Detection of CNV prior to substantial vision loss is critical as vision outcome following anti-angiogenic therapy is dependent on the visual acuity at initiation of treatment .
CONCLUSIONS	HOME Study is the first large scale study to test the use of home tele-monitoring system in the management of AMD patients .

###24807156
BACKGROUND	Avastin Biomarkers In lunG And 3D Innovative anaLysis ( ABIGAIL ) , which is a phase II , open-label , randomized study , investigated correlations between biomarkers and best overall response to bevacizumab plus platinum-doublet chemotherapy for patients with advanced/recurrent non-small-cell lung cancer .
METHODS	Patients received bevacizumab ( 7.5 or 15 mg/kg , 3-weekly until disease progression/unacceptable toxicity ) plus carboplatin/gemcitabine or carboplatin/paclitaxel ( maximum six cycles ) .
METHODS	Plasma samples ( baseline/throughout treatment ) were analyzed for vascular endothelial growth factor ( VEGF ) - A ( baseline only ) , VEGF receptors ( VEGFR-1 / VEGFR-2 ) , basic fibroblast growth factor , E-selectin , intercellular adhesion molecule-1 , and placental growth factor ( baseline only ) .
METHODS	Tumor samples ( primary specimen ) were analyzed for VEGF-A , VEGFR-1 / VEGFR-2 , neuropilin ( NRP ) , and CD31 .
METHODS	Response was evaluated at baseline and every 6 weeks ( Response Evaluation Criteria in Solid Tumors ) .
RESULTS	Patients were randomized to receive chemotherapy plus 7.5 mg/kg ( n = 154 ) or 15 mg/kg ( n = 149 ) bevacizumab .
RESULTS	For the primary analysis , none of the baseline plasma biomarkers correlated with best overall response .
RESULTS	Exploratory analyses showed that low VEGF-A levels were associated with longer progression-free survival ( 7.4 versus 6.1 months ; hazard ratio , 1.57 ; 95 % confidence intervals , 1.17 to 2.09 ; p = 0.002 ) and overall survival ( 19.8 versus 11.1 months ; hazard ratio , 1.57 ; 95 % confidence interval , 1.15-2 .13 ; p = 0.004 ) compared with these in high baseline plasma VEGF-A levels .
RESULTS	No plasma biomarkers changed significantly over time .
RESULTS	No significant correlations were observed between tumor biomarkers and clinical outcomes .
RESULTS	No new safety signals were observed .
CONCLUSIONS	Baseline and/or dynamic changes in plasma basic fibroblast growth factor , E-selectin , intercellular adhesion molecule-1 , placental growth factor , VEGFR-1 and VEGFR-2 , and tumor biomarkers did not correlate statistically with treatment outcomes for bevacizumab plus chemotherapy .
CONCLUSIONS	Only baseline plasma VEGF-A was significantly correlated with progression-free survival/overall survival .

###24716478
BACKGROUND	Evidence from armed conflict settings points to high levels of intimate partner violence ( IPV ) against women .
BACKGROUND	Current knowledge on how to prevent IPV is limited-especially within war-affected settings .
BACKGROUND	To inform prevention programming on gender-based violence in settings affected by conflict , we evaluated the impact of adding a targeted men 's intervention to a community-based prevention programme in Cte d'Ivoire .
METHODS	We conducted a two-armed , non-blinded cluster randomized trial in Cte d'Ivoire among 12 pair-matched communities spanning government-controlled , UN buffer , and rebel-controlled zones .
METHODS	The intervention communities received a 16-week IPV prevention intervention using a men 's discussion group format .
METHODS	All communities received community-based prevention programmes .
METHODS	Baseline data were collected from couples in September 2010 ( pre-intervention ) and follow-up in March 2012 ( one year post-intervention ) .
METHODS	The primary trial outcome was women 's reported experiences of physical and/or sexual IPV in the last 12 months .
METHODS	We also assessed men 's reported intention to use physical IPV , attitudes towards sexual IPV , use of hostility and conflict management skills , and participation in gendered household tasks .
METHODS	An adjusted cluster-level intention to treat analysis was used to compare outcomes between intervention and control communities at follow-up .
RESULTS	At follow-up , reported levels of physical and/or sexual IPV in the intervention arm had decreased compared to the control arm ( ARR 0.52 , 95 % CI 0.18-1 .51 , not significant ) .
RESULTS	Men participating in the intervention reported decreased intentions to use physical IPV ( ARR 0.83 , 95 % CI 0.66-1 .06 ) and improved attitudes toward sexual IPV ( ARR 1.21 , 95 % CI 0.77-1 .91 ) .
RESULTS	Significant differences were found between men in the intervention and control arms ' reported ability to control their hostility and manage conflict ( ARR 1.3 , 95 % CI 1.06-1 .58 ) , and participation in gendered household tasks ( ARR 2.47 , 95 % CI 1.24-4 .90 ) .
CONCLUSIONS	This trial points to the value of adding interventions working with men alongside community activities to reduce levels of IPV in conflict-affected settings .
CONCLUSIONS	The intervention significantly influenced men 's reported behaviours related to hostility and conflict management and gender equitable behaviours .
CONCLUSIONS	The decreased mean level of IPV and the differences between intervention and control arms , while not statistically significant , suggest that IPV in conflict-affected areas can be reduced through concerted efforts to include men directly in violence prevention programming .
CONCLUSIONS	A larger-scale trial is needed to replicate these findings and further understand the mechanisms of change .
BACKGROUND	clinicaltrials.gov NCT01803932 .

###24643485
OBJECTIVE	This paper describes the rationale , design , and methods of a two-year randomized controlled trial conducted to evaluate the effectiveness of an environmental intervention in 27 elementary schools in Mexico City .
METHODS	There were two units of analysis , school level addressing changes in elementary public part-time schools , and individual-level addressing behavioral changes in students 9 to 11 years of age .
METHODS	Two intensities of an intervention program were implemented ( basic and plus ) , each containing two intervention components : physical activity and nutrition , supported by a communication/education component .
METHODS	Evaluation of the intervention was carried out during the school cycles 2006-2007 and 2007-2008 .
RESULTS	Primary outcomes were overweight and obesity prevalence and fitness ; environmental and behavioural measures were also examined .
CONCLUSIONS	This is the first institutional multilevel , multifactorial project , consistent with the best practices available in current literature , carried out in Mexico to prevent childhood obesity in schools .

###24801218
BACKGROUND	PF-04447943 is a potent , selective phosphodiesterase 9A ( PDE9A ) inhibitor that elevates guanoscine 3 ' ,5 ' - cyclic monophosphate ( cGMP ) in brain and cerebrospinal fluid .
BACKGROUND	PDE9A inhibition enhances synaptic plasticity and improves memory in preclinical cognition models , and prevents decreases in dendritic spine density in transgenic mice that overexpress amyloid precursor protein ( APP ) leading to high levels of amyloid beta ( A ) production ( Tg2576 ) .
OBJECTIVE	This Phase 2 multicenter study was designed to assess the efficacy , safety and pharmacokinetics of PF-04447943 compared with placebo in mild to moderate probable Alzheimer 's disease ( AD ) .
METHODS	Subjects in overall good health with Mini Mental State Examination ( MMSE ) scores of 14-26 were randomized to 12 weeks treatment with PF-04447943 25 mg q12h ( n = 91 ) or placebo ( n = 100 ) .
METHODS	Concomitant acetylcholinesterase inhibitor or memantine use was excluded .
METHODS	The primary outcome was the Alzheimer 's Disease Assessment Scale - cognitive subscale ( ADAS-cog ) .
METHODS	The Neuropsychiatric Inventory ( NPI ) , Clinical Global Impression-Improvement scale ( CGI-I ) and standard safety measures were secondary outcomes .
RESULTS	Completion rates were similar , 87 % PF-04447943 vs 92 % placebo .
RESULTS	At week 12 the mean ( SE ) baseline adjusted decrease from baseline in ADAS cog for PF-04447943-treated patients was -1.91 ( 0.54 ) .
RESULTS	Placebo treated patients had a change of -1.60 ( 0.50 ) .
RESULTS	The difference between treatments was -0.31 ( 90 % CI of -1.52 , 0.90 ) .
RESULTS	Corresponding values for the NPI were -2.86 ( 0.72 ) vs -2.70 ( 0.67 ) with a treatment difference of -0.16 ( 90 % CI of -1.78 , 1.48 ) .
RESULTS	Neither these changes nor the distribution of CGI-I scores were statistically significantly different between groups .
RESULTS	The incidence of serious adverse events ( AEs ) was similar between groups with 2 deaths in the placebo group .
RESULTS	The PF-04447943 group reported more gastrointestinal AEs including diarrhea ( 5.5 % vs 3 % ) and nausea ( 5.5 % vs 1 % ) and had a higher rate of discontinuation due to AEs ( 6.6 % vs 2 % ) .
CONCLUSIONS	Although generally safe and well-tolerated , 12 weeks PF-04447943 treatment did not improve cognition , behavior , and global change compared with placebo .

###25951693
BACKGROUND	In most cases the only knowledge an individual will receive with regards to their own body and its proper functioning is during their high school education .
BACKGROUND	The aim of this study was to evaluate high school students ' knowledge about basic physiology .
METHODS	The research was carried out in five , randomly chosen high schools in Krakow , Poland .
METHODS	Young people in the age of 17-19 years were asked to fill in the questionnaire designed by the authors .
METHODS	The first part of the survey included personal data .
METHODS	The second part contained 20 close-ended questions assessing students ' knowledge about the basics of human physiology .
METHODS	Question difficulty varied from easy through average , and up to difficult .
METHODS	The maximum number of points to achieve was 20 .
RESULTS	One-thousand-and eighty-three ( out of 1179 invited -- 91.86 % ) Polish high school students ( 63.25 % female ) filled in a 20-item questionnaire constructed by the authors regarding basic human physiology .
RESULTS	The mean age of the group was 17.66 0.80 years .
RESULTS	The mean score among the surveyed was 10.15 3.48 ( range 0-20 ) .
RESULTS	Only 26.04 % of students achieved a grade of 60 % or more , and only one person obtained the highest possible score .
RESULTS	Females achieved significantly better scores than males ( 10.49 3.38 vs. 9.56 3.56 ; p < 0.0001 ) .
RESULTS	Pupils in their second year who were in the process of studying physiology , obtained better results than those in their third year who had already finished the biology course ( 10.70 3.27 vs. 9.81 3.74 respectively ; p < 0.0001 ) and those in their first year who did not yet study human physiology ( 10.70 3.27 vs. 9.63 2.74 respectively ; p = 0.003 ) .
RESULTS	Over 23 % of students did not know that mature red blood cells do not have cell nuclei and a similar number of them answered that humans have 500,000 erythrocytes in 1 mm3 of blood .
RESULTS	Over 32 % believed that plasma does not participate in the transport of respiratory gases , and 31 % believed that endocrine glands secrete hormones within their immediate vicinity and into the blood .
CONCLUSIONS	Our research has shown that young people , especially men , often lack basic physiological knowledge needed to make conscious and responsible decisions regarding their health .
CONCLUSIONS	Our results suggest that more emphasis should be put on properly teaching human physiology in high school , especially to those students who do not plan a career in medicine-related fields .
CONCLUSIONS	This study brings to light the disturbing fact that about a year after a student finishes his basic physiology course his knowledge of the subject returns to a pre high school level .

###24359267
BACKGROUND	With both a high need for recovery ( NFR ) and overweight and obesity being a potential burden for organizations ( e.g. productivity loss and sickness absence ) , the aim of this paper was to examine the associations between overweight and obesity and several other health measures and NFR in office workers .
METHODS	Baseline data of 412 office employees participating in a randomised controlled trial aimed at improving NFR in office workers were used .
METHODS	Associations between self-reported BMI categories ( normal body weight , overweight , obesity ) and several other health measures ( general health , mental health , sleep quality , stress and vitality ) with NFR were examined .
METHODS	Unadjusted and adjusted linear regression analyses were performed and adjusted for age , education and job demands .
METHODS	In addition , we adjusted for general health in the association between overweight and obesity and NFR .
RESULTS	A significant positive association was observed between stress and NFR ( B = 18.04 , 95 % CI :14.53 -21.56 ) .
RESULTS	General health , mental health , sleep quality and vitality were negatively associated with NFR ( p < 0.001 ) .
RESULTS	Analyses also showed a significant positive association between obesity and NFR ( B = 8.77 , 95 % CI :0.01 -17.56 ) , but not between overweight and NFR .
CONCLUSIONS	The findings suggest that self-reported stress is , and obesity may be , associated with a higher NFR .
CONCLUSIONS	Additionally , the results imply that health measures that indicate a better health are associated with a lower NFR .
BACKGROUND	The trial is registered at the Dutch Trial Register ( NTR ) under trial registration number : NTR2553 .

###24716668
BACKGROUND	Patients with chronic autoimmune thyroiditis have impaired health-related quality of life .
BACKGROUND	The thyroid gland has a high selenium concentration , and specific selenoprotein enzyme families are crucial to immune function , and catalyze thyroid hormone metabolism and redox processes in thyroid cells .
BACKGROUND	Previous randomized controlled trials have found that selenium supplementation decreases thyroid-disease-specific antibody levels .
BACKGROUND	We hypothesize that selenium might be beneficial in the treatment of chronic autoimmune thyroiditis .
METHODS	The CATALYST trial is an investigator-initiated randomized , blinded , multicentre clinical trial of selenium supplementation versus placebo in patients with chronic autoimmune thyroiditis .
METHODS	age 18 years ; serum thyroid peroxidase antibody level 100 IU/ml within the previous 12 months ; treatment with levothyroxine and written informed consent .
METHODS	previous diagnosis of toxic nodular goitre , Graves ' hyperthyroidism , postpartum thyroiditis , Graves ' orbitopathy ; previous antithyroid drug treatment , radioiodine therapy or thyroid surgery ; immune-modulatory or other medication affecting thyroid function ; pregnancy , planned pregnancy or breastfeeding ; allergy towards any intervention or placebo component ; intake of selenium supplementation > 55 g/day ; inability to read or understand Danish or lack of informed consent .
METHODS	The trial will include 2236 participants .
METHODS	The experimental intervention and control groups will receive 200 g selenium-enriched yeast or matching placebo tablets daily for 12 months .
METHODS	The experimental supplement will be SelenoPrecise .
METHODS	The primary outcome is thyroid-related quality of life assessed by the Thyroid Patient-Reported Outcome ( ThyPRO ) questionnaire .
METHODS	Secondary outcomes include serum thyroid peroxidase antibody concentration ; serum triiodothyronine/thyroxine ratio ; levothyroxine dosage ; adverse reactions and serious adverse reactions and events .
CONCLUSIONS	In this pragmatic trial , participating patients follow their usual treatment at their usual hospitals .
CONCLUSIONS	In order to collect high-quality data on the clinical course and quality of life , and to minimize missing data , an elaborate trial management system has been designed .
CONCLUSIONS	12 months intervention duration was selected in consideration of the primary outcome , thyroid-related quality of life .
BACKGROUND	ClinicalTrials.gov ID : NCT02013479 .

###25326140
BACKGROUND	Asthma is a chronic inflammatory airway disease characterized by reversible obstruction , inflammation and hyperresponsiveness to different stimulus .
BACKGROUND	Aerobic and breathing exercises have been demonstrated to benefit asthmatic patients ; however , there is no evidence comparing the effectiveness of these treatments .
METHODS	This is a prospective , comparative , blinded , and randomized clinical trial with 2 groups that will receive distinct interventions .
METHODS	Forty-eight asthmatic adults with optimized medical treatment will be randomly divided into either aerobic ( AG ) or breathing exercises ( BG ) .
METHODS	Patients will perform breathing or aerobic exercise twice a week for 3months , totalizing 24 sessions of 40minutes each .
METHODS	Before intervention , both groups will complete an educational program consisting of 2 educational classes .
METHODS	Before and after interventions , the following parameters will be quantified : clinical control ( main outcome ) , health related quality of life , levels of anxiety and depression , daily living physical activity and maximal exercise capacity ( secondary outcome ) .
METHODS	Hyperventilation syndrome symptoms , autonomic nervous imbalance , thoracoabdominal kinematics , inflammatory cells in the sputum , fraction of exhaled nitric oxide ( FENO ) and systemic inflammatory cytokines will also be evaluated as possible mechanisms to explain the benefits of both interventions .
CONCLUSIONS	Although the benefits of breathing and aerobic exercises have been extensively studied , the comparison between both has never been investigated .
CONCLUSIONS	Furthermore , the findings of our results will allow us to understand its application and suitability to patients that will have more benefits for every intervention optimizing its effect .
BACKGROUND	Clinicaltrials.gov ; Identifier : NCT02065258 .

###25592188
BACKGROUND	Although whole-body vibration ( WBV ) has sparked tremendous research interest in neurorehabilitation , the cardiovascular responses to WBV in people with stroke remain unknown .
OBJECTIVE	The aim of this study was to determine the acute effects of different WBV protocols on oxygen consumption ( Vo2 ) , heart rate ( HR ) , rate of perceived exertion ( RPE ) , blood pressure ( BP ) , and rate-pressure product ( RPP ) during the performance of 6 different exercises among people with chronic stroke ( time since onset 6 months ) .
METHODS	A repeated-measures design was used .
METHODS	Each of the 48 participants experienced all 3 WBV protocols in separate sessions : ( 1 ) no WBV , ( 2 ) low-intensity WBV ( peak acceleration = 0.96 unit of gravity of Earth [ g ] ) , and ( 3 ) high-intensity WBV ( 1.61 g ) .
METHODS	The order in which they encountered the WBV protocols was randomized , as was the order of exercises performed during each session .
METHODS	Oxygen consumption , HR , and RPE were measured throughout the study .
METHODS	Blood pressure and RPP were measured before and after each session .
RESULTS	Low-intensity and high-intensity WBV induced significantly higher Vo2 by an average of 0.69 and 0.79 mL/kg/min , respectively , compared with the control condition .
RESULTS	These protocols also increased HR by an average of 4 bpm .
RESULTS	The 2 WBV protocols induced higher RPE than the control condition during static standing exercise only .
RESULTS	Although the diastolic and systolic BP and RPP were increased at the end of each exercise session , the addition of WBV had no significant effect on these variables .
CONCLUSIONS	The results are generalizable only to ambulatory and community-dwelling people with chronic stroke .
CONCLUSIONS	Addition of high - and low-intensity WBV significantly increased the Vo2 and HR , but the increase was modest .
CONCLUSIONS	Thus , WBV should not pose any substantial cardiovascular hazard in people with chronic stroke .

###26154787
BACKGROUND	Little is known about the effect of specific anti-interleukin-23 therapy , as compared with established anti-tumor necrosis factor therapies , for the treatment of moderate-to-severe plaque psoriasis .
METHODS	In a 52-week , phase 2 , dose-ranging , randomized , double-blind , placebo-controlled , active-comparator trial , we compared guselkumab ( CNTO 1959 ) , an anti-interleukin-23 monoclonal antibody , with adalimumab in patients with moderate-to-severe plaque psoriasis .
METHODS	A total of 293 patients were randomly assigned to receive guselkumab ( 5 mg at weeks 0 and 4 and every 12 weeks thereafter , 15 mg every 8 weeks , 50 mg at weeks 0 and 4 and every 12 weeks thereafter , 100 mg every 8 weeks , or 200 mg at weeks 0 and 4 and every 12 weeks thereafter ) through week 40 , placebo , or adalimumab ( standard dosage for psoriasis ) .
METHODS	At week 16 , patients in the placebo group crossed over to receive guselkumab at a dose of 100 mg every 8 weeks .
METHODS	The primary end point was the proportion of patients with a Physician 's Global Assessment ( PGA ) score of 0 ( indicating cleared psoriasis ) or 1 ( indicating minimal psoriasis ) at week 16 .
RESULTS	At week 16 , the proportion of patients with a PGA score of 0 or 1 was significantly higher in each guselkumab group than in the placebo group : 34 % in the 5-mg group , 61 % in the 15-mg group , 79 % in the 50-mg group , 86 % in the 100-mg group , and 83 % in the 200-mg group , as compared with 7 % in the placebo group ( P0 .002 for all comparisons ) .
RESULTS	Moreover , the proportion was significantly higher in the 50-mg , 100-mg , and 200-mg guselkumab groups than in the adalimumab group ( 58 % ) ( P < 0.05 for all comparisons ) .
RESULTS	At week 16 , the proportion of patients with at least a 75 % improvement in Psoriasis Area and Severity Index scores was significantly higher in each guselkumab group than in the placebo group ( P < 0.001 for all comparisons ) .
RESULTS	At week 40 , the proportion of patients with a PGA score of 0 or 1 remained significantly higher in the 50-mg , 100-mg , and 200-mg guselkumab groups than in the adalimumab group ( 71 % , 77 % , and 81 % , respectively , vs. 49 % ) ( P < 0.05 for all comparisons ) .
RESULTS	Between week 0 and week 16 , infections were observed in 20 % of the patients in the guselkumab groups , 12 % in the adalimumab group , and 14 % in the placebo group .
CONCLUSIONS	The results of this phase 2 trial suggest that guselkumab may be an effective therapy for plaque psoriasis and that control of psoriasis can be achieved with specific anti-interleukin-23 therapy .
CONCLUSIONS	( Funded by Janssen Research and Development ; X-PLORE ClinicalTrials.gov number , NCT01483599 . )

###26323937
BACKGROUND	The role of trypanocidal therapy in patients with established Chagas ' cardiomyopathy is unproven .
METHODS	We conducted a prospective , multicenter , randomized study involving 2854 patients with Chagas ' cardiomyopathy who received benznidazole or placebo for up to 80 days and were followed for a mean of 5.4 years .
METHODS	The primary outcome in the time-to-event analysis was the first event of any of the components of the composite outcome of death , resuscitated cardiac arrest , sustained ventricular tachycardia , insertion of a pacemaker or implantable cardioverter-defibrillator , cardiac transplantation , new heart failure , stroke , or other thromboembolic event .
RESULTS	The primary outcome occurred in 394 patients ( 27.5 % ) in the benznidazole group and in 414 ( 29.1 % ) in the placebo group ( hazard ratio , 0.93 ; 95 % confidence interval [ CI ] , 0.81 to 1.07 ; P = 0.31 ) .
RESULTS	At baseline , a polymerase-chain-reaction ( PCR ) assay was performed on blood samples obtained from 1896 patients ; 60.5 % had positive results for Trypanosoma cruzi on PCR .
RESULTS	The rates of conversion to negative PCR results ( PCR conversion ) were 66.2 % in the benznidazole group and 33.5 % in the placebo group at the end of treatment , 55.4 % and 35.3 % , respectively , at 2 years , and 46.7 % and 33.1 % , respectively , at 5 years or more ( P < 0.001 for all comparisons ) .
RESULTS	The effect of treatment on PCR conversion varied according to geographic region : in Brazil , the odds ratio for PCR conversion was 3.03 ( 95 % CI , 2.12 to 4.34 ) at 2 years and 1.87 ( 95 % CI , 1.33 to 2.63 ) at 5 or more years ; in Colombia and El Salvador , the odds ratio was 1.33 ( 95 % CI , 0.90 to 1.98 ) at 2 years and 0.96 ( 95 % CI , 0.63 to 1.45 ) at 5 or more years ; and in Argentina and Bolivia , the odds ratio was 2.63 ( 95 % CI , 1.89 to 3.66 ) at 2 years and 2.79 ( 95 % CI , 1.99 to 3.92 ) at 5 or more years ( P < 0.001 for interaction ) .
RESULTS	However , the rates of PCR conversion did not correspond to effects on clinical outcome ( P = 0.16 for interaction ) .
CONCLUSIONS	Trypanocidal therapy with benznidazole in patients with established Chagas ' cardiomyopathy significantly reduced serum parasite detection but did not significantly reduce cardiac clinical deterioration through 5 years of follow-up .
CONCLUSIONS	( Funded by the Population Health Research Institute and others ; ClinicalTrials.gov number , NCT00123916 ; Current Controlled Trials number , ISRCTN13967269 . )

###25787999
BACKGROUND	Emotional eating in children has been related to the consumption of energy-dense foods and obesity , but the development of emotional eating in young children is poorly understood .
OBJECTIVE	We evaluated whether emotional eating can be induced in 5-7-y-old children in the laboratory and assessed whether parental use of overly controlling feeding practices at 3-5 y of age predicts a greater subsequent tendency for children to eat under conditions of mild stress at ages 5-7 y.
METHODS	Forty-one parent-child dyads were recruited to participate in this longitudinal study , which involved parents and children being observed consuming a standard lunch , completing questionnaire measures of parental feeding practices , participating in a research procedure to induce child emotion ( or a control procedure ) , and observing children 's consumption of snack foods .
RESULTS	Children at ages 5-7 y who were exposed to a mild emotional stressor consumed significantly more calories from snack foods in the absence of hunger than did children in a control group .
RESULTS	Parents who reported the use of more food as a reward and restriction of food for health reasons with their children at ages 3-5 y were more likely to have children who ate more under conditions of negative emotion at ages 5-7 y.
CONCLUSIONS	Parents who overly control children 's food intake may unintentionally teach children to rely on palatable foods to cope with negative emotions .
CONCLUSIONS	Additional research is needed to evaluate the implications of these findings for children 's food intake and weight outside of the laboratory setting .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01122290 .

###24388839
OBJECTIVE	To compare the effects of trimethoprim-sulfamethoxazole vs placebo in reducing the risk of recurrences of Toxoplasma gondii retinochoroiditis .
METHODS	Single-center , prospective randomized double-masked clinical trial .
METHODS	A total of 95 patients from Campinas , Brazil , with active recurrent Toxoplasma gondii retinochoroiditis were included .
METHODS	The initially active toxoplasmosis lesions were successfully treated in all cases using trimethoprim-sulfamethoxazole ( 800 mg/160 mg ) twice daily for 45 days .
METHODS	Subsequently , 5 patients dropped out of the study .
METHODS	The remaining patients were randomized to Group 1 ( trimethoprim/sulfamethoxazole tablet every 2 days ) or Group 2 ( identical placebo tablet every 2 days ) .
METHODS	Randomization was 1:1 , was stratified by sex , and used block sizes of 4 .
METHODS	The primary outcome was recurrent toxoplasmosis retinochoroiditis within 1 year , and the secondary outcome was a 1-year change in best-corrected visual acuity ( BCVA ) ( ETDRS chart ) .
RESULTS	The incidence of recurrent toxoplasmosis retinochoroiditis within 12 months was 0 of 46 ( 0 % ) and 6 of 47 ( 12.80 % ) in the trimethoprim-sulfamethoxazole and placebo groups , respectively ( P = .026 ) .
RESULTS	Visual acuity improvements in the 2 groups were similar .
RESULTS	No treatment-limiting toxicity was observed .
CONCLUSIONS	Trimethoprim/sulfamethoxazole therapy resulted in a 100 % reduction in the recurrence of Toxoplasma gondii retinochoroiditis over 1 year of treatment .

###24626738
OBJECTIVE	Antisocial personality is a common adult problem that imposes a major public health burden , but for which there is no effective treatment .
OBJECTIVE	Affected individuals exhibit persistent antisocial behavior and pervasive antisocial character traits , such as irritability , manipulativeness , and lack of remorse .
OBJECTIVE	Prevention of antisocial personality in childhood has been advocated , but evidence for effective interventions is lacking .
METHODS	The authors conducted two follow-up studies of randomized trials of group parent training .
METHODS	One involved 120 clinic-referred 3 - to 7-year-olds with severe antisocial behavior for whom treatment was indicated , 93 of whom were reassessed between ages 10 and 17 .
METHODS	The other involved 109 high-risk 4 - to 6-year-olds with elevated antisocial behavior who were selectively screened from the community , 90 of whom were reassessed between ages 9 and 13 .
METHODS	The primary psychiatric outcome measures were the two elements of antisocial personality , namely , antisocial behavior ( assessed by a diagnostic interview ) and antisocial character traits ( assessed by a questionnaire ) .
METHODS	Also assessed were reading achievement ( an important domain of youth functioning at work ) and parent-adolescent relationship quality .
RESULTS	In the indicated sample , both elements of antisocial personality were improved in the early intervention group at long-term follow-up compared with the control group ( antisocial behavior : odds ratio of oppositional defiant disorder = 0.20 , 95 % CI = 0.06 , 0.69 ; antisocial character traits : B = -4.41 , 95 % CI = -1.12 , -8.64 ) .
RESULTS	Additionally , reading ability improved ( B = 9.18 , 95 % CI = 0.58 , 18.0 ) .
RESULTS	Parental expressed emotion was warmer ( B = 0.86 , 95 % CI = 0.20 , 1.41 ) and supervision was closer ( B = -0.43 , 95 % CI = -0.11 , -0.75 ) , but direct observation of parenting showed no differences .
RESULTS	Teacher-rated and self-rated antisocial behavior were unchanged .
RESULTS	In contrast , in the selective high-risk sample , early intervention was not associated with improved long-term outcomes .
CONCLUSIONS	Early intervention with severely antisocial children for whom treatment is indicated may prevent the development of antisocial personality in adolescence and may improve academic performance .
CONCLUSIONS	In contrast , early intervention with selective high-risk samples may be ineffective .

###25675682
OBJECTIVE	The authors compared the baby enclosed afferent reservoir ( Baby EAR ) with the Jackson-Rees ( JR ) anesthesia circuit for the minimal fresh gas flow ( FGF ) requirement with no and clinically acceptable rebreathing in spontaneous breathing anesthesia among pediatric patients .
METHODS	The present study was a randomized crossover study .
METHODS	Twenty patients , weighing 5 to 20 kg with ASA physical status I-II were enrolled .
METHODS	They were allocated to group 1 ( EAR-JR ) starting with Baby EAR then switching to JR or group 2 ( JR-EAR ) , reversedpattern .
METHODS	After induction and intubation , anesthesia was maintainedwith a N2O/O2 combination with sevoflurane 1 to 3 % and fentanyl .
METHODS	Starting with the first circuit , all patients were spontaneously ventilated with FGF 500 mL/kg/min for 10 minutes , and then gradually decreased by 50 mL/kg/min every five minutes .
METHODS	End-tidal CO2 ( ETCO ) and inspired minimum CO2 ( imCO ) were recorded until rebreathing ( imCO2 > 2 mmHg ) occurred and continued until rebreathing was not clinically acceptable ( imCO2 > 6 mmHg ) .
METHODS	The anesthesia breathing circuit was switched and the procedure repeated .
RESULTS	The minimal FGF at no rebreathing of Baby EAR and JR were 192.576.6 and 347.5108.2 mL/kg/min ; p < 0.001 .
RESULTS	At acceptable rebreathing , the values were 117.546.7 and 227.690.6 mL/kg/min ; p < 0.001 .
CONCLUSIONS	Baby EAR can be used safely , effectively , and requires less FGF than JR in pediatric anesthesia in patients weighing 5 to 20 kg .

###25008873
OBJECTIVE	To study the effects of extensively hydrolyzed protein formula ( eHF ) on the feeding and growth in preterm infants through a multicenter controlled clinical study .
METHODS	Preterm infants admitted to eight upper first-class hospitals in China between February 2012 and December 2013 were randomly selected .
METHODS	They were divided into two observation groups and two control groups .
METHODS	The first observation group consisted of preterm infants with a gestational age of < 32 weeks , who were fed with eHF for 10-14 days after birth and then with standard preterm formula ( SPF ) until discharge .
METHODS	The second observation group consisted of preterm infants with a gestational age of 32-34 weeks , who were fed with SPF after birth , but were switched to eHF ( 7-14 days ) if suffering feeding intolerance at 6-8 days after birth .
METHODS	The two control groups with corresponding gestational ages kept to be fed with SPF after birth .
METHODS	Clinical data were recorded to compare feeding condition , physical growth , blood biochemical indices , and major complications between different groups .
RESULTS	A total of 328 preterm infants were enrolled .
RESULTS	Preterm infants with a gestational age of < 32 weeks in the observation group had a significantly shorter meconium evacuation time than in the corresponding control group ( P < 0.05 ) .
RESULTS	They also had significantly lower levels of serum total bilirubin at weeks 1 and 2 after birth compared with the control group ( P < 0.05 ) .
RESULTS	The observation group needed more time in reaching enteral nutrition ( EN ) basic energy uptake of 50 kcal / ( kgd ) , partial parenteral nutrition ( PPN ) , hospitalization , and corrected gestational age at discharge compared with the controlled infants ( P < 0.05 ) .
RESULTS	There was no difference in the incidence of extrauterine growth retardation ( EUGR ) at discharge between the two groups ( P > 0.05 ) .
RESULTS	Preterm infants with a gestational age of 32-34 weeks in the observation group had significantly lower serum total bilirubin levels at 2 weeks after birth compared with the corresponding control group ( P < 0.05 ) .
RESULTS	They required more time in achieving EN basic energy and PPN than in the control group ( P < 0.05 ) .
RESULTS	There was no difference in the incidence of EUGR at discharge between the two groups ( P > 0.05 ) .
CONCLUSIONS	For preterm infants , eHF can improve gastrointestinal motility , accelerate bilirubin metabolism and excretion and does not increase the incidence of EUGR .

###24529485
OBJECTIVE	To investigate the effect of a computer-supported indirect-form lifestyle-modification program using Lifestyle Intervention Support Software for Diabetes Prevention ( LISS-DP ) , as a clinically feasible strategy for primary prevention , on diet and physical activity habits in adults with a family history of type 2 diabetes .
METHODS	This was a two-arm , randomized controlled trial : ( 1 ) lifestyle intervention ( LI ) group ( n = 70 ) ; ( 2 ) control ( n = 71 ) .
METHODS	Healthy adults aged 30-60 years with a history of type 2 diabetes among their first-degree relatives were recruited .
METHODS	LI group received three times of lifestyle intervention using LISS-DP during six-month intervention period via mail .
RESULTS	Lifestyle intervention group showed significantly greater decrease in energy intake six months after baseline , compared to control ( -118.31 and -24.79 kcal/day , respectively , p = 0.0099 , Cohen 's d = 0.22 ) , though the difference disappeared 1 year after from baseline .
RESULTS	No difference was found in physical activity energy expenditure .
CONCLUSIONS	A computer-based , non-face-to-face lifestyle intervention was effective on dietary habits , only during the intervention period .
CONCLUSIONS	Further examination of the long-term effects of such intervention and physical activity is required .

###24232938
OBJECTIVE	The present study aimed to compare the postoperative contrast sensitivity functions between wavefront-guided LASIK eyes and their contralateral wavefront-guided PRK eyes .
METHODS	The participants were 11 healthy subjects ( mean age = 32.4 6.2 years ) who had myopic astigmatism .
METHODS	The spatial contrast sensitivity functions were measured before and three times after the surgery .
METHODS	Psycho and a Cambridge graphic board ( VSG 2/4 ) were used to measure luminance , red-green , and blue-yellow spatial contrast sensitivity functions ( from 0.85 to 13.1 cycles/degree ) .
METHODS	Longitudinal analysis and comparison between surgeries were performed .
RESULTS	There was no significant contrast sensitivity change during the one-year follow-up measurements neither for LASIK nor for PRK eyes .
RESULTS	The comparison between procedures showed no differences at 12 months postoperative .
CONCLUSIONS	The present data showed similar contrast sensitivities during one-year follow-up of wave-front guided refractive surgeries .
CONCLUSIONS	Moreover , one year postoperative data showed no differences in the effects of either wavefront-guided LASIK or wavefront-guided PRK on the luminance and chromatic spatial contrast sensitivity functions .

###25713429
OBJECTIVE	Survivors of cervical cancer experience quality-of-life ( QOL ) disruptions that persist years after treatment .
OBJECTIVE	This study examines the effect of a psychosocial telephone counseling ( PTC ) intervention on QOL domains and associations with biomarkers .
METHODS	We conducted a randomized clinical trial in survivors of cervical cancer , who were 9 and less than 30 months from diagnosis ( n = 204 ) , to compare PTC to usual care ( UC ) .
METHODS	PTC included five weekly sessions and a 1-month booster .
METHODS	Patient-reported outcomes ( PROs ) and biospecimens were collected at baseline and 4 and 9 months after enrollment .
METHODS	Changes in PROs over time and associations with longitudinal change in cytokines as categorical variables were analyzed using multivariable analysis of variance for repeated measures .
RESULTS	Participant mean age was 43 years ; 40 % of women were Hispanic , and 51 % were non-Hispanic white .
RESULTS	Adjusting for age and baseline scores , participants receiving PTC had significantly improved depression and improved gynecologic and cancer-specific concerns at 4 months compared with UC participants ( all P < .05 ) ; significant differences in gynecologic and cancer-specific concerns ( P < .05 ) were sustained at 9 months .
RESULTS	Longitudinal change in overall QOL and anxiety did not reach statistical significance .
RESULTS	Participants with decreasing interleukin ( IL ) -4 , IL-5 , IL-10 , and IL-13 had significantly greater improvement in QOL than those with increasing cytokine levels .
CONCLUSIONS	This trial confirms that PTC benefits mood and QOL cancer-specific and gynecologic concerns for a multiethnic underserved population of survivors of cancer .
CONCLUSIONS	The improvement in PROs with decreases in T-helper type 2 and counter-regulatory cytokines supports a potential biobehavioral pathway relevant to cancer survivorship .

###25259704
BACKGROUND	There is a paucity of data on the effect of antiretroviral medications on male fertility .
BACKGROUND	Couples affected by HIV-1 often have fertility intentions , and antiretroviral medications , as both treatment of HIV-1-infected persons and pre-exposure prophylaxis ( PrEP ) for uninfected persons , are part of peri-conception risk reduction .
METHODS	Within a randomized , placebo-controlled trial of daily oral tenofovir disoproxil fumarate ( TDF ) and combination emtricitabine ( FTC ) / TDF PrEP for HIV-1 prevention conducted among heterosexual HIV-1-serodiscordant couples , we assessed the impact of TDF and FTC/TDF use on male fertility , measured as incident pregnancy in female partners of men assigned to PrEP vs. placebo .
RESULTS	Of the 2962 HIV-1-uninfected men partners , 986 were randomized to TDF , 1013 to FTC/TDF , and 963 to placebo .
RESULTS	The overall pregnancy incidence in their HIV-1-infected female partners was 12.9 per 100 person-years and did not differ significantly across the study arms ( 13.2 TDF , 12.4 FTC/TDF , 13.2 placebo ) .
RESULTS	The frequency of live births , pregnancy losses , and gestational age at birth or loss was also statistically similar in the three randomization groups .
CONCLUSIONS	TDF and FTC/TDF , when used as PrEP by HIV-1-uninfected men , did not adversely affect male fertility or pregnancy outcomes .

###25188297
BACKGROUND	Tiotropium is a once-daily , long-acting anticholinergic bronchodilator with the potential to alleviate airway obstruction in cystic fibrosis .
BACKGROUND	Our objective was to evaluate the efficacy and safety of 2.5 and 5 g once-daily tiotropium delivered via the Respimat Soft Mist Inhaler vs. placebo in people with cystic fibrosis .
METHODS	This phase 2 , 12-week , randomized , double-blind , placebo-controlled parallel-group study of tiotropium Respimat as add-on to usual cystic fibrosis maintenance therapy included people with cystic fibrosis with pre-bronchodilator forced expiratory volume in 1 second ( FEV1 ) 25 % predicted .
METHODS	Co-primary efficacy end points were change from baseline in percent-predicted FEV1 area under the curve from 0 to 4 hours ( FEV1 AUC0-4h ) , and trough FEV1 at the end of week 12 .
RESULTS	A total of 510 subjects with cystic fibrosis aged 5-69 years were randomized .
RESULTS	Both doses of tiotropium resulted in significant improvement compared with placebo in the co-primary efficacy end points at the end of week 12 ( change from baseline in percent-predicted FEV1 AUC0-4h : 2.5 g : 2.94 % , 95 % confidence interval 1.19-4 .70 , p = 0.001 ; 5 g : 3.39 % , 95 % confidence interval 1.67-5 .12 , p = 0.0001 ; in percent-predicted trough FEV1 2.5 g : 2.24 % , p = 0.2 ; 5 g : 2.22 % , p = 0.02 ) .
RESULTS	There was a greater benefit with tiotropium 5 vs. 2.5 g. No treatment-related adverse events or unexpected safety findings were observed in patients taking tiotropium .
CONCLUSIONS	Tiotropium significantly improved lung function in people with cystic fibrosis .
CONCLUSIONS	The improvement was greater with the higher dose than the lower dose , with no difference in adverse events .
BACKGROUND	ClinicalTrials.gov NCT00737100 EudraCT 2008-001156-43 .

###24918372
BACKGROUND	Obstructive sleep apnea is associated with hypertension , inflammation , and increased cardiovascular risk .
BACKGROUND	Continuous positive airway pressure ( CPAP ) reduces blood pressure , but adherence is often suboptimal , and the benefit beyond management of conventional risk factors is uncertain .
BACKGROUND	Since intermittent hypoxemia may underlie cardiovascular sequelae of sleep apnea , we evaluated the effects of nocturnal supplemental oxygen and CPAP on markers of cardiovascular risk .
METHODS	We conducted a randomized , controlled trial in which patients with cardiovascular disease or multiple cardiovascular risk factors were recruited from cardiology practices .
METHODS	Patients were screened for obstructive sleep apnea with the use of the Berlin questionnaire , and home sleep testing was used to establish the diagnosis .
METHODS	Participants with an apnea-hypopnea index of 15 to 50 events per hour were randomly assigned to receive education on sleep hygiene and healthy lifestyle alone ( the control group ) or , in addition to education , either CPAP or nocturnal supplemental oxygen .
METHODS	Cardiovascular risk was assessed at baseline and after 12 weeks of the study treatment .
METHODS	The primary outcome was 24-hour mean arterial pressure .
RESULTS	Of 318 patients who underwent randomization , 281 ( 88 % ) could be evaluated for ambulatory blood pressure at both baseline and follow-up .
RESULTS	On average , the 24-hour mean arterial pressure at 12 weeks was lower in the group receiving CPAP than in the control group ( -2.4 mm Hg ; 95 % confidence interval [ CI ] , -4.7 to -0.1 ; P = 0.04 ) or the group receiving supplemental oxygen ( -2.8 mm Hg ; 95 % CI , -5.1 to -0.5 ; P = 0.02 ) .
RESULTS	There was no significant difference in the 24-hour mean arterial pressure between the control group and the group receiving oxygen .
RESULTS	A sensitivity analysis performed with the use of multiple imputation approaches to assess the effect of missing data did not change the results of the primary analysis .
CONCLUSIONS	In patients with cardiovascular disease or multiple cardiovascular risk factors , the treatment of obstructive sleep apnea with CPAP , but not nocturnal supplemental oxygen , resulted in a significant reduction in blood pressure .
CONCLUSIONS	( Funded by the National Heart , Lung , and Blood Institute and others ; HeartBEAT ClinicalTrials.gov number , NCT01086800 . )

###24672814
BACKGROUND	Oxidative stress and inflammation during cardiac surgery may be associated with acute renal injury ( ARI ) .
BACKGROUND	N-acetyl cysteine ( NAC ) and carvedilol have antioxidant and anti-inflammatory properties .
OBJECTIVE	A combination of carvedilol and NAC should decrease the incidence of ARI more than metoprolol or carvedilol .
METHODS	Patients undergoing cardiac surgery were randomized to metoprolol , carvedilol , or carvedilol plus NAC .
METHODS	End points were occurrence of ARI and change in preoperative to postoperative peak creatinine levels .
RESULTS	ARI incidence was lower in the carvedilol plus NAC group compared with the metoprolol ( 21.0 % vs 42.1 % ; P = 0.002 ) or carvedilol ( 21.0 % vs 38.6 % ; P = 0.006 ) groups , but was similar between the metoprolol and carvedilol groups ( P = 0.62 ) .
RESULTS	Preoperative and postoperative day 1 creatinine levels were similar among the metoprolol ( 1.02 [ 0.9-1 .2 ] and 1.2 [ 0.92-1 .45 ] ) the carvedilol ( 1.0 [ 0.88-1 .08 ] and 1.2 [ 0.9-1 .5 ] ) and the carvedilol plus NAC groups ( 1.06 [ 0.9-1 .18 ] and 1.1 [ 1.0-1 .21 ] mg/dL ; all P values > 0.05 ) .
RESULTS	Postoperative day 3 , day 5 , and peak creatinine levels were lower in the carvedilol plus NAC group ( 1.11 [ 1.0-1 .23 ] , 1.14 [ 1.0-1 .25 ] and 1.15 [ 1.0-1 .25 ] ) as compared with the metoprolol ( 1.4 [ 1.3-1 .49 ] , 1.3 [ 1.0-1 .54 ] and 1.3 [ 1.0-1 .54 ] ) or carvedilol groups ( 1.2 [ 1.0-1 .52 ] , 1.25 [ 1.0-1 .52 ] and 1.25 [ 1.0-1 .55 ] mg/dL ; all P values < 0.05 ) , but were similar between the metoprolol and carvedilol groups ( all P values > 0.05 ) .
CONCLUSIONS	Combined carvedilol and NAC decreased ARI incidence as compared with carvedilol or metoprolol .
CONCLUSIONS	No difference was detected between carvedilol and metoprolol .

###25178668
BACKGROUND	Ticagrelor has been shown to improve outcomes in patients with ACS .
BACKGROUND	However , the effects of this drug on parameters of microvascular flow in patients presenting with ST-segment elevation myocardial infarction ( STEMI ) have not been completely evaluated .
METHODS	Ninety-two patients presenting with STEMI where randomized to a loading dose of clopidogrel ( 600 mg ) or ticagrelor ( 180 mg ) before undergoing primary angioplasty .
METHODS	We assessed angiographic and electrocardiographic parameters of myocardial reperfusion .
METHODS	Blinded operators calculated angiographic corrected TIMI Frame count ( cTFC ) and myocardial blush grade ( MBG ) before and after stent implantation .
METHODS	ST segment resolution was also measured in all patients .
METHODS	Primary endpoint was cTFC after PCI .
METHODS	Secondary endpoints were cTFC prior to PCI , TIMI flow grade , MBG and the percentage of ST resolution .
RESULTS	Of the 92 randomized patients , 70 patients were analyzed .
RESULTS	Mean age of patients was 58.810 years .
RESULTS	Patients presented with a mean ischemic time of 4.42.6 hours .
RESULTS	There were no significant differences in the time between loading dose and stent deployment ( 35.236.4 in ticagrelor and 42.729.5 min in clopidogrel , p = 0.36 ) .
RESULTS	cTFC before angioplasty was significantly lower in ticagrelor than in clopidogrel ( 81.129.4 vs. 95.117.5 frames respectively , p = 0.01 ) .
RESULTS	After angioplasty there were no differences between ticagrelor and clopidogrel in cTFC ( 24.69.3 vs. 27.013.4 frames respectively , p = 0.62 ) ; MBG grade 3 was present in 76.4 vs. 69.4 % of patients , respectively ( p = 0.41 ) .
RESULTS	The percentage of ST resolution did not show any differences between groups ( 84.823.4 in ticagrelor vs. 70.833.7 in clopidogrel , p = 0.36 ) .
CONCLUSIONS	Compared with clopidogrel , ticagrelor loading in patients presenting with STEMI is not associated with an improvement of angiographic and electrocardiographic parameters of myocardial reperfusion after angioplasty .

###25249172
OBJECTIVE	Povidone iodine is used primarily as an antiseptic to decrease surgical site infection .
OBJECTIVE	Its hemostatic and antiedematous properties in oral surgery also have been investigated recently .
METHODS	A randomized controlled clinical trial was performed in 30 patients undergoing mandibular third molar removal in a split-mouth design .
METHODS	In the study group , a povidone iodine solution with a concentration of 0.5 mg/mL was used as the coolant and irrigant solution , whereas normal saline was used in the control group .
METHODS	Swelling ( orotragus and mentotragus distances ) , trismus ( maximum interincisal opening ) , and pain ( visual analog scale score ) were evaluated on postoperative days 2 and 7 .
RESULTS	In the study group , a significant decrease in swelling and trismus was observed at the 2 postoperative visits ( P = .00 ) compared with the control group .
RESULTS	The decrease of pain in the study group was not statistically significant at either postoperative visit ( P > .05 ) .
RESULTS	More patients ( 63 % ) were subjectively satisfied with the side treated with povidone iodine .
CONCLUSIONS	Povidone iodine irrigation is an inexpensive and safe method to lessen the postoperative sequelae of third molar surgery .

###24960402
BACKGROUND	Pertuzumab plus trastuzumab provides a more comprehensive blockade of HER2 signalling than trastuzumab alone .
BACKGROUND	Therefore , we conducted a phase IIa study of the pharmacokinetics and safety of pertuzumab plus trastuzumab and chemotherapy in advanced gastric cancer ( aGC ) .
METHODS	Patients received pertuzumab 840 mg for cycle 1 and 420 mg q3w for cycles 2-6 ( Arm A ) or pertuzumab 840 mg q3w for six cycles ( Arm B ) .
METHODS	Trastuzumab , cisplatin and capecitabine were also given for six cycles , then trastuzumab q3w until disease progression or unmanageable toxicity .
METHODS	The co-primary endpoints were day 43 pertuzumab serum trough concentration ( Cmin ) and safety .
RESULTS	Thirty patients were randomised .
RESULTS	Mean pertuzumab Cmin at day 43 was 40.0 g ml ( -1 ) ( s.d. : 17.3 ) in Arm A and 62.7 g ml ( -1 ) ( 29.1 ) in Arm B. Mean day 43 Cmin in Arm A was ~ 37 % lower than that seen in metastatic breast cancer .
RESULTS	The safety profiles were similar between arms and treatment was well tolerated .
RESULTS	Partial responses were achieved by 86 % and 55 % of patients in Arms A and B , respectively .
CONCLUSIONS	On the basis of the pharmacokinetic and safety data , the 840 mg q3w pertuzumab dose has been selected for a phase III study of pertuzumab , trastuzumab and chemotherapy in HER2-positive aGC .

###24889937
OBJECTIVE	There are significant health disparities between Mori and non-Mori with asthma , a pattern seen between other ethnic populations .
OBJECTIVE	This study investigates outcomes for Mori in a randomized controlled trial ( RCT ) of combination budesonide/formoterol inhaler therapy in asthma .
METHODS	This 24-week multicentre RCT recruited 303 adult asthma patients , 44 of whom were Mori .
METHODS	Participants were randomized to the single combination budesonide/formoterol inhaler as maintenance and reliever therapy ( ` SMART ' ) regimen or ` standard ' regimen ( combination budesonide/formoterol inhaler for maintenance and salbutamol as reliever ) .
METHODS	Outcomes included patterns of beta-agonist inhaler use including ` high use ' of reliever therapy ( > 8 actuations of budesonide/formoterol in excess of four maintenance doses per day for SMART and > 16 actuations per day of salbutamol for standard ) .
METHODS	Differences in outcomes for Mori versus non-Mori were assessed using an interaction term between ethnicity and treatment .
RESULTS	With adjustment for ethnicity , the SMART group had fewer days of high use ( relative rate ( RR ) 0.57 ( 95 % confidence interval ( CI ) : 0.38-0 .85 ) ) , days of high use without medical review within 48 h ( RR 0.49 ( 95 % CI : 0.32-0 .75 ) ) and severe exacerbations ( RR 0.54 ( 95 % CI : 0.36-0 .81 ) ) compared with standard .
RESULTS	The magnitude of the benefit from the SMART regimen was similar in Mori and non-Mori .
RESULTS	Regardless of treatment regimen , Mori demonstrated more days of high use , high use without medical review and underuse of maintenance therapy .
CONCLUSIONS	The SMART regimen has a favourable risk/benefit profile in Mori .
CONCLUSIONS	Days of high use , days of high use without medical review and underuse of maintenance treatment were greater in Mori , regardless of treatment regimen .

###26010029
BACKGROUND	Early infant male circumcision ( EIMC ) is a potential key HIV prevention intervention , providing it can be safely and efficiently implemented in sub-Saharan Africa .
BACKGROUND	Here , we present results of a randomized noninferiority trial of EIMC comparing the AccuCirc device with Mogen clamp in Zimbabwe .
METHODS	Between January and June 2013 , eligible infants were randomized to EIMC through either AccuCirc or Mogen clamp conducted by a doctor , using a 2:1 allocation ratio .
METHODS	Participants were followed for 14 days post-EIMC .
METHODS	Primary outcomes for the trial were EIMC safety and acceptability .
RESULTS	One hundred fifty male infants were enrolled in the trial and circumcised between 6 and 54 days postpartum ( n = 100 AccuCirc ; n = 50 Mogen clamp ) .
RESULTS	Twenty-six infants ( 17 % ) were born to HIV-infected mothers .
RESULTS	We observed 2 moderate adverse events ( AEs ) [ 2 % , 95 % confidence interval ( CI ) : 0.2 to 7.0 ] in the AccuCirc arm and none ( 95 % CI : 0.0 to 7.1 ) in the Mogen clamp arm .
RESULTS	The cumulative incident risk of AEs was 2.0 % higher in the AccuCirc arm compared with the Mogen Clamp arm ( 95 % CI : -0.7 to 4.7 ) .
RESULTS	As the 95 % CI excludes the predefined noninferiority margin of 6 % , the result provides evidence of noninferiority of AccuCirc compared with the Mogen clamp .
RESULTS	Nearly all mothers ( 99.5 % ) reported great satisfaction with the outcome .
RESULTS	All mothers , regardless of arm said they would recommend EIMC to other parents , and would circumcise their next son .
CONCLUSIONS	This first randomized trial of AccuCirc versus Mogen clamp for EIMC demonstrated that EIMC using these devices is safe and acceptable to parents .
CONCLUSIONS	There was no difference in the rate of AEs by device .

###25755093
OBJECTIVE	This randomized , cross-over trial was designed to investigate the metabolic and appetitive responses to skipping breakfast in overweight women who were habitual breakfast Eaters or Skippers .
METHODS	Nine Eaters and nine Skippers were studied on two separate days during which subjects ate breakfast ( B ) or had no breakfast ( NB ) , followed by a standard lunch meal 4 h later .
METHODS	Blood sampling for hormones and metabolites was performed after lunch , and appetite was rated throughout the day .
RESULTS	Interactions between day and habitual breakfast pattern were seen for area under the curve ( AUC ) for insulin and free fatty acids ( FFA ) .
RESULTS	Both insulin ( P = 0.020 ) and FFA ( P = 0.023 ) AUC were higher on the NB day for Eaters but similar on both days for Skippers .
RESULTS	Eaters had higher pre lunch hunger AUC on the NB day ( P = 0.015 ) as well as lower pre lunch satiety AUC under both conditions ( P = 0.019 ) .
CONCLUSIONS	Overall , this study showed that the adverse effects of skipping breakfast ( higher insulin and FFA responses to lunch , increased hunger , and decreased satiety ) were found primarily in habitual breakfast eaters .
CONCLUSIONS	This suggests that meal skipping may have enhanced effects in habitual Eaters due to entrainment of metabolic and appetitive regulatory systems .

###25097089
OBJECTIVE	The aim of this study was to compare the combined ultrasound-guided supraclavicular brachial plexus block ( SCB ) and distal median , radial , and ulnar nerve blocks , with the supraclavicular block alone .
METHODS	Sixty-two patients undergoing upper extremity surgery were randomized to supraclavicular only ( Group S , n = 31 ) or supraclavicular + distal ( Group SD , n = 31 ) group .
METHODS	Patients in Group S received 32mL of 1.5 % lidocaine + epinephrine 5g/mL , while those in Group SD received 20mL of 1.5 % lidocaine + epinephrine 5g/mL followed by distal median , radial , and ulnar nerve blocks using equal volumes of 2 % lidocaine +0.5 % levobupivacaine ( 4mL/nerve ) .
METHODS	Sensory and motor blocks of the ulnar , median , radial and musculocutaneous nerves were assessed every 5min starting at the 10th minute .
METHODS	The imaging , needling and performance times were recorded .
METHODS	Also , the onset and anesthesia-related times , need for analgesic and first analgesic times , were noted .
RESULTS	In Group SD , the anesthesia onset [ 15 ( 10-25 ) vs. 20 ( 15-30 ) min , p < 0.001 ] and anesthesia related times [ 16.6 ( 10.7-28 .2 ) vs. 22 ( 15.9-33 .7 ) min , p < 0.001 ] were significantly shorter than those of Group S. Additionally , the analgesic requirement was lower in Group SD ( 56.7 vs. 88.5 % , p = 0.009 ) , while among the patients who required analgesic , the first analgesic time was longer in Group SD in comparison to Group S [ 625 ( 347-1764 ) vs. 315 ( 233-746 ) min p < 0.001 ] .
CONCLUSIONS	The addition of distal median , radial , and ulnar nerve blocks to SCB shortens anesthesia-related time and anesthesia onset time when compared with a SCB alone .

###24532004
BACKGROUND	Patients suffering from mild-to-moderate medial compartment knee osteoarthritis may be treated with an unloader knee orthosis .
BACKGROUND	However , compliance has been shown to be an issue with such devices .
OBJECTIVE	The aim of this study was to identify the effects of a new design of knee unloader orthosis on specific gait parameters in patients with mild-to-moderate medial knee osteoarthritis .
METHODS	The gait of seven patients was assessed in two conditions : without an orthosis and when wearing a new design of unloader knee orthosis .
METHODS	Gait analysis was performed to determine alterations to the adduction moment , speed of walking , step length , cadence and knee sagittal plane range of motion during ambulation for the two test conditions .
RESULTS	The knee adduction moment was significantly reduced ( p = 0.001 ) , and the speed of walking significantly increased ( p < 0.001 ) when wearing the orthosis .
RESULTS	However , a reduction in knee range of motion ( p = 0.002 ) and an increase in step length ( p < 0.001 ) were observed with the orthosis donned .
RESULTS	Cadence was not significantly altered ( p = 0.504 ) .
CONCLUSIONS	The use of a new design of unloader knee orthosis as a conservative treatment approach for patients with mild-to-moderate medial compartment osteoarthritis appears warranted .
CONCLUSIONS	Various conservative modalities have been used to reduce pain and improve function in medial compartment osteoarthritis .
CONCLUSIONS	A new design of an unloader knee orthosis has been developed and is shown to have immediate benefits in patients with mild medial knee osteoarthritis .

###24444988
OBJECTIVE	To determine the effects of a small-dose ketamine-propofol combination used for sedation during spinal anesthesia on tourniquet-induced ischemia-reperfusion injury .
METHODS	Prospective randomized study .
METHODS	Training and research hospital .
METHODS	60 adult , ASA physical status 1 and 2 patients , ages 20-60 years , scheduled for elective arthroscopic knee surgery for meniscal and chondral lesions .
METHODS	The initial hemodynamic parameters were recorded and blood samples were collected at baseline ( T1 ) ; then spinal anesthesia was performed .
METHODS	In Group I ( n = 30 ) , a combination of 0.5 mg/kg/hr of ketamine and 2 mg/kg/hr of propofol was administered ; Group II ( n = 30 ) received an equivalent volume of saline as an infusion .
METHODS	A pneumatic tourniquet was applied .
METHODS	Malondialdehyde ( MDA ) , superoxide dismutase ( SOD ) , and catalase levels were measured one minute before tournique deflation in the ischemic period ( T2 ) , then 5 ( T3 ) and 30 ( T4 ) minutes following tourniquet deflation in the reperfusion period .
RESULTS	No differences were noted between groups in hemodynamic data ( P > 0.05 ) or SOD levels ( P > 0.05 ) .
RESULTS	In Group I , MDA levels at T2 were lower than in Group II ( P < 0.05 ) .
RESULTS	In Group I , catalase levels were lower at T2 and T4 than they were in Group II ( P < 0.05 ) .
CONCLUSIONS	Small-dose ketamine-propofol combination may be useful in reducing tourniquet-induced ischemia-reperfusion injury in arthroscopic knee surgery .

###24974387
BACKGROUND	Black men exhibit a high prevalence of vitamin D deficiency as well as a higher incidence of prostate cancer and higher mortality rates from prostate cancer than Whites .
BACKGROUND	There are few data about the effect of vitamin D3 ( cholecalciferol ) supplementation on prostate-specific antigen ( PSA ) in healthy Black men .
METHODS	During three winters from 2007 to 2010 , 105 Black men ( median age , 48.9 years ) of Boston , MA were randomized into a four-arm , double-blind trial for 3 months of placebo , 1,000 , 2,000 , or 4,000 U of vitamin D3 .
METHODS	At baseline and 3 months , free and total PSA was measured .
RESULTS	With vitamin D supplementation , no significant differences in free and total PSA were observed ; free PSA , -0.0004 ng/mL ( P = 0.94 ) and total PSA , -0.004 ng/mL ( P = 0.92 ) for each additional 1,000 U/d of vitamin D3 .
CONCLUSIONS	Within an unselected population of healthy Black men without a cancer diagnosis , we found no effect of vitamin D supplementation on free or total PSA .
CONCLUSIONS	These findings support prior findings of no change in PSA with vitamin D supplementation and emphasize the need for new methods to assess the influence of vitamin D supplementation on prostate cancer prevention .

###24923986
BACKGROUND	Treating schizophrenia patients who fail to respond to antipsychotics is a major challenge , and the percentage of treatment-resistant patients is estimated to be 20-25 % .
BACKGROUND	Recent studies indicate that yokukansan ( YKS ; D2 and 5HT1A partial agonist and 5HT2A and glutamate antagonist ) to be safe and useful in treating behavioral and psychological symptoms associated with dementia and other neuropsychiatric conditions .
BACKGROUND	We aimed at evaluating both the efficacy and safety of YKS in patients with treatment-resistant schizophrenia .
METHODS	This randomized , multicenter , double-blind , placebo-controlled study was conducted between May 2010 and August 2012 .
METHODS	One hundred twenty antipsychotic-treated inpatients from 34 psychiatric hospitals in Japan were included .
METHODS	Patients were randomized to adjuvant treatment with YKS 7.5 g/day or placebo .
METHODS	During a 4-week follow-up , psychopathology was assessed using the Positive and Negative Syndrome Scale ( PANSS ) with five factors [ excitement/hostility ( P4 , P7 , G8 , and G14 ) , depression/anxiety ( G1 , G2 , G3 , G4 , and G6 ) , cognition ( P2 , N5 , N7 , G5 , G10 , G11 , G12 , G13 , and G15 ] , positive ( P1 , P3 , P5 , P6 , and G9 ) , and negative ( N1 , N2 , N3 , N4 , N6 , G7 , and G16 ] ] .
METHODS	Other assessments included , Clinical Global Impression-Severity ( CGI-S ) , Global Assessment of Functioning ( GAF ) , and Drug-Induced Extrapyramidal Symptoms Scale ( DIEPSS ) .
METHODS	The primary efficacy outcome was the change in PANSS five-factor scores .
METHODS	The secondary outcomes were changes in the scores of CGI-S .
METHODS	The analysis was made on a modified intention to treat basis with the help of a last observation carried forward method .
RESULTS	YKS showed a tendency of superiority to placebo in reducing total all PANSS five-factor scores in treatment-resistant schizophrenia , but the difference was not statistically significant in total , depression/anxiety , cognition , positive , and negative factors .
RESULTS	However , compared to the placebo group , the YKS group showed statistically significant improvements in the PANSS excitement/hostility factor scores ( p < 0.05 ) .
RESULTS	No substantial side effects were recorded .
CONCLUSIONS	The results of the present study indicate YKS to be a potential adjunctive treatment strategy for treatment-resistant schizophrenia , particularly to improve excitement/hostility symptoms .

###24673045
OBJECTIVE	To evaluate the therapeutic effect on pain in the dressing change after perianal abscess surgery treated with warm suspending moxibustion at Changqiang ( GV 1 ) .
METHODS	One hundred and sixty patients were randomized into a moxibustion group and a far-infrared therapy group , 80 cases in each one .
METHODS	In the moxibustion group , the warm suspending moxibustion at Changqiang ( GV 1 ) was applied .
METHODS	In the far-infrared therapy group , the infrared ray was radiated at Changqiang ( GV 1 ) .
METHODS	The treatment started in 10 min after dressing change in the two groups .
METHODS	Totally , 8 treatments were required .
METHODS	The time requirement being equal to or less than 2 score in the assessment face scale ( AFS ) , the case number of pain relief in 10 min after treatment and the intention of the two therapies after everyday dressing change were observed in the patients of the two groups .
RESULTS	In the moxibustion group , the time of pain relief was shorter than that of the far-infrared therapy group [ ( 11.5 + / - 3.9 ) min vs ( 17.8 + / - 3.8 ) min on the 1st day ; ( 9.4 + / - 3.6 ) min vs ( 15.2 + / - 4.3 ) min on the 2nd day ; ( 7.8 + / - 2.7 ) min vs ( 14.3 + / - 3.2 ) min on the 3rd day ; ( 6.4 + / - 3.3 ) min vs ( 10.5 + / - 2.9 ) min on the 4th day ; ( 5.9 + / - 2.9 ) min vs ( 11.2 + / - 1.9 ) min on the 5th day ; ( 5.3 + / - 2.2 ) min vs ( 8.8 + / - 2.3 ) min on the 6th day ; ( 5.4 + / - 1.8 ) min vs ( 9.2 + / - 2.1 ) min on the 7th day ; ( 5.1 + / - 1.4 ) min vs ( 9.5 + / - 2.6 ) min on the 8th day , all P < 0.05 ] .
RESULTS	The case numbers of pain relief in 10 min after treatment were 74 cases , 75 cases , 77 cases and 78 cases from the 1st to the 4th day separately in the moxibustion group , which were much more than 63 cases , 65 cases , 68 cases and 69 cases in the far-infrared therapy group ( all P < 0.05 ) .
RESULTS	The treatment intention scores in the moxibustion group were better than those in the far-infrared therapy group ( all P < 0.05 ) .
CONCLUSIONS	The warm suspending moxibustion at Changqiang ( GV 1 ) relieves pain rapidly in the dressing change of much more patients after perianal abscess surgery in much shorter time as compared with the far-infrared therapy .
CONCLUSIONS	Moreover , the patients have more expectation to be treated with moxibustion therapy .

###25559834
OBJECTIVE	To prospectively assess the antiinflammatory effect of volatile anesthetic sevoflurane in patients undergoing open lung surgery with one lung ventilation ( OLV ) .
METHODS	This prospective , randomized study included 40 patients undergoing thoracic surgery with OLV ( NCT02188407 ) .
METHODS	The patients were randomly allocated into two equal groups that received either propofol or sevoflurane .
METHODS	Four patients were excluded from the study because after surgery they received blood transfusion or non-steroid antiinflammatory drugs .
METHODS	Inflammatory mediators ( interleukins 6 , 8 , and 10 , C-reactive protein [ CRP ] , and procalcitonin ) were measured perioperatively .
METHODS	The infiltration of the nonoperated lung was assessed on chest x-rays and the oxygenation index was calculated .
METHODS	The major postoperative complications were counted .
RESULTS	Interleukin 6 levels were significantly higher in propofol than in sevoflurane group ( P = 0.014 ) .
RESULTS	Preoperative CRP levels did not differ between the groups ( P = 0.351 ) and in all patients they were lower than 20 mg/L , but postoperative CRP was significantly higher in propofol group ( 316 vs 157 ng/L ; P = 0.035 ) ; Pre - and postoperative procalcitonin was within the reference range ( < 0.04 g/L ) in both groups .
RESULTS	The oxygenation index was significantly lower in propofol group ( 339139 vs 465140 ; P = 0.021 ) .
RESULTS	There was no significant difference between the groups in lung infiltrates ( P = 0.5849 ) .
RESULTS	The number of postoperative adverse events was higher in propofol group , but the difference was not-significant ( 5 vs 1 ; P = 0.115 ) .
CONCLUSIONS	The study suggests an antiinflammatory effect of sevoflurane in patients undergoing thoracotomy with OLV .

###24989152
OBJECTIVE	There is a paucity of controlled treatment trials for the treatment of conversion disorder , seizures type , also known as psychogenic nonepileptic seizures ( PNES ) .
OBJECTIVE	Psychogenic nonepileptic seizures , the most common conversion disorder , are as disabling as epilepsy and are not adequately addressed or treated by mental health clinicians .
OBJECTIVE	To evaluate different PNES treatments compared with standard medical care ( treatment as usual ) .
METHODS	Pilot randomized clinical trial at 3 academic medical centers with mental health clinicians trained to administer psychotherapy or psychopharmacology to outpatients with PNES .
METHODS	Thirty-eight participants were randomized in a blocked schedule among 3 sites to 1 of 4 treatment arms and were followed up for 16 weeks between September 2008 and February 2012 ; 34 were included in the analysis .
METHODS	Medication ( flexible-dose sertraline hydrochloride ) only , cognitive behavioral therapy informed psychotherapy ( CBT-ip ) only , CBT-ip with medication ( sertraline ) , or treatment as usual .
METHODS	Seizure frequency was the primary outcome ; psychosocial and functioning measures , including psychiatric symptoms , social interactions , quality of life , and global functioning , were secondary outcomes .
METHODS	Data were collected prospectively , weekly , and with baseline , week 2 , midpoint ( week 8 ) , and exit ( week 16 ) batteries .
METHODS	Within-group analyses for each arm were performed on primary ( seizure frequency ) and secondary outcomes from treatment-blinded raters using an intention-to-treat analysis .
RESULTS	The psychotherapy ( CBT-ip ) arm showed a 51.4 % seizure reduction ( P = .01 ) and significant improvement from baseline in secondary measures including depression , anxiety , quality of life , and global functioning ( P < .001 ) .
RESULTS	The combined arm ( CBT-ip with sertraline ) showed 59.3 % seizure reduction ( P = .008 ) and significant improvements in some secondary measures , including global functioning ( P = .007 ) .
RESULTS	The sertraline-only arm did not show a reduction in seizures ( P = .08 ) .
RESULTS	The treatment as usual group showed no significant seizure reduction or improvement in secondary outcome measures ( P = .19 ) .
CONCLUSIONS	This pilot randomized clinical trial for PNES revealed significant seizure reduction and improved comorbid symptoms and global functioning with CBT-ip for PNES without and with sertraline .
CONCLUSIONS	There were no improvements in the sertraline-only or treatment-as-usual arms .
CONCLUSIONS	This study supports the use of manualized psychotherapy for PNES and successful training of mental health clinicians in the treatment .
CONCLUSIONS	Future studies could assess larger-scale intervention dissemination .
BACKGROUND	clinicaltrials.gov Identifier : NCT00835627 .

###25454967
OBJECTIVE	This study compared the therapeutic effects of collateral meridian therapy ( CMT ) with traditional acupoint pressure therapy ( APT ) in patients with unilateral upper back pain .
METHODS	Forty-nine patients with active myofascial trigger points in upper trapezius muscle were randomly allocated to the control ( CTL ) , APT , or CMT group .
METHODS	Each subject in the CMT and APT groups received 2 sessions of treatment per week over 1 month .
RESULTS	Patients in the APT and CMT groups showed significant improvements 1 month after treatment in visual analogue scale , range of motion , pain pressure threshold , regional superficial blood flow , and physical health , as compared to the CTL group .
RESULTS	No significant differences in outcome measures were found between APT and CMT groups 1 month after treatment .
CONCLUSIONS	Both APT and CMT have comparable therapeutic efficacy in the treatment of unilateral upper back pain with active myofascial trigger points in the upper trapezius muscle .

###25248648
BACKGROUND	It remains unknown whether local anaesthetic dose is the only factor influencing continuous popliteal-sciatic nerve block effects , or whether concentration , volume , or both exert an influence as well .
METHODS	Bilateral sciatic catheters were inserted in volunteers ( n = 24 ) .
METHODS	Catheters were randomly assigned to ropivacaine of either 0.1 % ( 8 ml h ( -1 ) ) or 0.4 % ( 2 ml h ( -1 ) ) for 6 h.
METHODS	The primary endpoint was the tolerance to transcutaneous electrical stimulation within the tibial nerve distribution at hour 6 .
METHODS	Secondary endpoints included current tolerance at other time points and plantar flexion maximum voluntary isometric contraction ( 22 h total ) .
RESULTS	At hour 6 , tolerance to cutaneous stimulation for limbs receiving 0.1 % ropivacaine was [ mean ( standard deviation ) ] 27.0 ( 20.2 ) vs26 .9 ( 20.4 ) mA for limbs receiving 0.4 % [ estimated mean difference 0.2 mA ; 90 % confidence interval ( CI ) -8.2 to 8.5 ; P = 0.02 and 0.03 for lower and upper boundaries , respectively ] .
RESULTS	Because the 90 % CI fell within the prespecified tolerance 10 mA , we conclude that the effect of the two concentration/volume combinations were equivalent .
RESULTS	Similar negative findings were found for the secondary outcomes .
CONCLUSIONS	For continuous popliteal-sciatic nerve blocks , we found no evidence that local anaesthetic concentration and volume influence block characteristics , suggesting that local anaesthetic dose ( mass ) is the primary determinant of perineural infusion effects in this anatomic location .
CONCLUSIONS	These findings suggest that for ambulatory perineural local anaesthetic infusion-for which there is usually a finite local anaesthetic reservoir-decreasing the basal rate while increasing the local anaesthetic concentration may allow for increased infusion duration without compromising postoperative analgesia .
BACKGROUND	NCT01898689 .

###24586534
BACKGROUND	In VOICE , a multisite HIV pre-exposure prophylaxis ( PrEP ) trial , plasma drug levels pointed to widespread product nonuse , despite high adherence estimated by self-reports and clinic product counts .
BACKGROUND	Using a socio-ecological framework ( SEF ) , we explored socio-cultural and contextual factors that influenced participants ' experience of daily vaginal gel and oral tablet regimens in VOICE .
METHODS	In Johannesburg , a qualitative ancillary study was concurrently conducted among randomly selected VOICE participants assigned to in-depth interviews ( n = 41 ) , serial ethnographic interviews ( n = 21 ) , or focus group discussions ( n = 40 ) .
METHODS	Audiotaped interviews were transcribed , translated , and coded thematically for analysis .
RESULTS	Of the 102 participants , the mean age was 27 years , and 96 % had a primary sex partner with whom 43 % cohabitated .
RESULTS	Few women reported lasting nonuse , which they typically attributed to missed visits , lack of product replenishments , and family-related travel or work .
RESULTS	Women acknowledged occasionally skipping or mistiming doses because they forgot , were busy , felt lazy or bored , feared or experienced side effects .
RESULTS	However , nearly all knew or heard of other study participants who did not use products daily .
RESULTS	Three overarching themes emerged from further analyses : ambivalence toward research , preserving a healthy status , and managing social relationships .
RESULTS	These themes highlighted the profound and complex meanings associated with participating in a blinded HIV PrEP trial and taking antiretroviral-based products .
RESULTS	The unknown efficacy of products , their connection with HIV infection , challenges with daily regimen given social risks , lack of support-from partners and significant others-and the relationship tradeoffs entailed by using the products appear to discourage adequate product use .
CONCLUSIONS	Personal acknowledgment of product nonuse was challenging .
CONCLUSIONS	This qualitative inquiry highlighted key influences at all SEF levels that shaped women 's perceptions of trial participation and experiences with investigational products .
CONCLUSIONS	Whether these impacted women 's behaviors and may have contributed to ineffective trial results warrants further investigation .

###24772504
OBJECTIVE	To improve the quality of eradication therapy ( ET ) , by increasing patient compliance .
METHODS	An open-label cohort multicenter randomized study was conducted .
METHODS	A total of 350 patients with Helicobacter pylori infection-associated diseases and indications for ET were examined .
METHODS	Work was done to improve compliance in a study patient group before treatment .
RESULTS	In the study group of patients motivated for treatment , the efficiency of ET was significantly higher than in the control group .
RESULTS	The factors influencing treatment adherence were identified and methods to optimize compliance during H. pylori eradication were developed .
CONCLUSIONS	Awareness of the essence of the disease in a patient and his higher motivation for compliance are one of the components of successful H. pylori eradication .

###25113275
OBJECTIVE	Motor learning results in changes of movement representation in primary motor cortex ( M1 ) a process involving long-term potentiation ( LTP ) .
OBJECTIVE	Pairing motor training with repetitive transcranial magnetic stimulation ( rTMS ) of M1 enhances the formation of a motor memory .
OBJECTIVE	Here we determined the effect of pairing M1 stimulation and the execution of training movements at different times and frequencies on the formation of a motor memory .
METHODS	Formation of a motor memory was defined as increases in motor evoked potentials ( MEP ) of the training agonist ( extensor carpi ulnaris muscle , ECU ) and increases in peak acceleration of the trained movements that last more than 60min .
METHODS	Training consisted of auditory-paced ballistic wrist extension movements ( 30min , 0.5 Hz ) paired with 0.1 , 0.25 or 0.5 Hz subthreshold rTMS .
METHODS	The rTMS pulse was applied at either the onset , 100ms prior to or 300ms after the onset of training movement related increases in electromyographic ( EMG ) activity of ECU .
METHODS	This was compared to a Sham condition .
RESULTS	Only 0.1 Hz rTMS applied at the onset of the training related increase in ECU-EMG activity resulted in increases in MEP amplitudes and peak acceleration when compared to the Sham .
CONCLUSIONS	The formation of motor memory is enhanced above the nave level by co-administration of low frequency rTMS at the time of execution of training movements .
CONCLUSIONS	These results indicate the importance of time and frequency of rTMS in these settings and should be considered in the design of rehabilitation treatment strategies using rTMS .

###24402888
BACKGROUND	Various devices have been developed to facilitate liver transection and reduce blood loss in liver resections .
BACKGROUND	None of these has proven superiority compared with the classical clamp-crushing technique .
BACKGROUND	This randomized clinical trial compared the effectiveness and safety of stapler transection with that of clamp-crushing during open liver resection .
METHODS	Patients admitted for elective open liver resection between January 2010 and October 2011 were assigned randomly to stapler transection or the clamp-crushing technique .
METHODS	The primary endpoint was the total amount of intraoperative blood loss .
METHODS	Secondary endpoints included transection time , duration of operation , complication rates and resection margins .
RESULTS	A total of 130 patients were enrolled , 65 to clamp-crushing and 65 to stapler transection .
RESULTS	There was no difference between groups in total intraoperative blood loss : median ( i.q.r. ) 1050 ( 525-1650 ) versus 925 ( 450-1425 ) ml respectively ( P = 0279 ) .
RESULTS	The difference in total intraoperative blood loss normalized to the transection surface area was not statistically significant ( P = 0092 ) .
RESULTS	Blood loss during parenchymal transection was significantly lower in the stapler transection group ( P = 0002 ) , as were the parenchymal transection time ( mean ( s.d. ) 30 ( 21 ) versus 9 ( 7 ) min for clamp-crushing and stapler transection groups respectively ; P < 0001 ) and total duration of operation ( mean ( s.d. ) 221 ( 86 ) versus 190 ( 85 ) min ; P = 0047 ) .
RESULTS	There were no significant differences in postoperative morbidity ( P = 0863 ) or mortality ( P = 0684 ) between groups .
CONCLUSIONS	Stapler transection is a safe technique but does not reduce intraoperative blood loss in elective liver resection compared with the clamp-crushing technique .
BACKGROUND	NCT01049607 ( http://www.clinicaltrials.gov ) .

###25163399
BACKGROUND	The effect of oral polio vaccine administered already at birth ( OPV0 ) on child survival was not examined before being recommended in 1985 .
BACKGROUND	Observational data suggested that OPV0 was harmful for boys , and trials have shown that neonatal vitamin A supplementation ( NVAS ) at birth may be beneficial for boys .
BACKGROUND	We set out to test this research question in a randomised trial .
METHODS	The trial was carried out at the Bandim Health Project , Guinea-Bissau .
METHODS	We planned to enrol 900 low-birth weight ( LBW ) boys in a randomised trial to investigate whether NVAS instead of OPV0 could lower infant mortality for LBW boys .
METHODS	At birth , the children were randomised to OPV ( usual treatment ) or VAS ( intervention treatment ) and followed for 6 months for growth and 12 months for survival .
METHODS	Hazard Ratios ( HR ) for mortality were calculated using Cox regression .
METHODS	We compared the individual anthropometry measurements to the 2006 WHO growth reference .
METHODS	We compared differences in z-scores by linear regression .
METHODS	Relative risks ( RR ) of being stunted or underweight were calculated in Poisson regression models with robust standard errors .
RESULTS	In the rainy season we detected a cluster of deaths in the VAS group and the trial was halted immediately with 232 boys enrolled .
RESULTS	The VAS group had significantly higher mortality than the OPV0 group in the rainy season ( HR : 9.91 ( 1.23 - 80 ) ) .
RESULTS	All deaths had had contact with the neonatal nursery ; of seven VAS boys enrolled during one week in September , six died within two months of age , whereas only one died among the six boys receiving OPV ( p = 0.05 ) .
RESULTS	Growth ( weight and arm-circumference ) in the VAS group was significantly worse until age 3 months .
CONCLUSIONS	VAS at birth instead of OPV was not beneficial for the LBW boys in this study .
CONCLUSIONS	With the premature closure of the trial it was not possible to answer the research question .
CONCLUSIONS	However , the results of this study call for extra caution when testing the effect of NVAS in the future .
BACKGROUND	http://www.clinicaltrials.govNCT00625482 .
BACKGROUND	Registered 18 February 2008 .

###24627301
BACKGROUND	Dual orexin receptor antagonists ( DORAs ) enable initiation and maintenance of sleep in patients with primary insomnia .
BACKGROUND	Blockade of the orexin system has shown reduction of drug-seeking behavior in animal studies , supporting the role of orexin antagonism as a novel approach for treating substance abuse .
BACKGROUND	Since hypnotics are traditionally associated with misuse , a lack of abuse liability of DORAs would offer significant benefits over current therapies for sleep disorders .
METHODS	In this randomized , crossover , proof-of-concept study , single oral doses of the DORA almorexant ( 200 , 400 , and 1,000 mg ) were administered to healthy subjects with previous non-therapeutic experience with central nervous system depressants and were compared with placebo and single oral doses of zolpidem ( 20 and 40 mg ) , a benzodiazepine-like drug .
METHODS	Subjective measures of abuse potential ( visual analog scales [ VAS ] , Addiction Research Center Inventory , and Subjective Drug Value ) and objective measures ( divided attention [ DA ] ) were evaluated over 24 h post-dose in 33 evaluable subjects .
RESULTS	Drug Liking VAS peak effect ( E max ; primary endpoint ) was significantly higher for all doses of almorexant and zolpidem compared with placebo ( p < 0.001 ) .
RESULTS	Almorexant 200 mg showed significantly less ` Drug Liking ' than both zolpidem doses ( p < 0.01 ) , and almorexant 400 mg had smaller effects than zolpidem 20 mg ( p < 0.05 ) , while almorexant 1,000 mg was not different from either zolpidem dose .
RESULTS	Results were similar for other subjective measures , although almorexant generally showed smaller negative and perceptual effects compared with zolpidem .
RESULTS	Almorexant also showed less cognitive impairment compared with zolpidem on most DA endpoints .
CONCLUSIONS	This study in humans investigating single doses of almorexant is the first to explore and show abuse liability of a DORA , a class of compounds that is not only promising for the treatment of sleep disorders , but also of addiction .

###24256453
OBJECTIVE	Music therapy is an innovative approach to support people with severe mental illness ( SMI ) .
OBJECTIVE	The aim of the study was to determine whether group music therapy ( GMT ) positively impacted on quality of life ( QoL ) , social enrichment , self-esteem , spirituality and psychiatric symptoms of participants with SMI and how they experienced the intervention .
METHODS	The primary outcome was QoL ; secondary measures assessed social enrichment , self-esteem , spirituality and psychiatric symptoms .
METHODS	The 13-week intervention comprised singing familiar songs and composing original songs recorded in a professional studio .
METHODS	Qualitative data were generated from focus group interviews and song lyric analysis .
RESULTS	Ninety-nine adults ( 57 female ) were recruited , with an initial cohort ( n = 75 ) randomized to either : weekly GMT followed by standard care ( SC ) or SC followed by GMT .
RESULTS	Crossover occurred after 13 weeks .
RESULTS	Measures were conducted at baseline , 13 , 26 and 39 weeks .
RESULTS	A second cohort ( n = 24 ) could not be randomized and were assigned to GMT followed by SC .
RESULTS	Intention-to-treat analysis showed a significant difference between GMT and SC on QoL and spirituality .
RESULTS	This was robust to different assumptions about missing data ( listwise deletion , last observation carried forward or multiple imputation ) .
RESULTS	Per-protocol analysis suggested greater benefit for those receiving more sessions .
RESULTS	Focus group interview and song lyric analyses suggested that GMT was enjoyable ; self-esteem was enhanced ; participants appreciated therapists and peers ; and although challenges were experienced , the programme was recommended to others .
CONCLUSIONS	Group music therapy may enhance QoL and spirituality of persons with SMI .

###25488080
OBJECTIVE	To test the application in practice of computerized fetal heart rate ( FHR ) analysis in pregnancy .
METHODS	Randomized distribution of subjects with computerized analysis automatically revealed or concealed .
METHODS	A district general hospital and a teaching hospital outside London .
METHODS	2869 pregnant women studied within a year .
METHODS	Quality and duration of the cardiotocogram ; quantitative measurement of FHR variation ; number of stillbirths .
RESULTS	With interactive advice to the operator , records were of improved quality ( up to 28 % without signal loss ) with potentially much reduced recording time .
RESULTS	The short-term FHR variation measured in the last records before intervention is reported for the first time .
CONCLUSIONS	The benefits of using the computers include improvement in record quality and saving of time .
CONCLUSIONS	In addition , where interpretation depended on estimation of FHR variation there was prima facie evidence of observer misinterpretation ; visual analysis was unreliable .
CONCLUSIONS	A larger trial is now required with more rigorous constraints on intervention .

###25741971
BACKGROUND	Widespread use of 7-valent pneumococcal conjugate vaccine ( PCV7 ) in children has led to significant reduction in pneumococcal disease in children and adults .
BACKGROUND	However , diseases caused by serotypes not included in PCV7 have increased .
BACKGROUND	A 15-valent pneumococcal conjugate vaccine ( PCV15 ) containing serotypes in PCV7 and 8 additional serotypes ( 1 , 3 , 5 , 6A , 7F , 19A , 22F , 33F ) was developed and evaluated in toddlers 12 to 15 months of age .
METHODS	Ninety toddlers who completed an infant series with PCV7 received a single dose of either aluminum-adjuvanted PCV15 , nonadjuvanted PCV15 , or PCV7 .
METHODS	Injection-site and systemic adverse events ( AEs ) were collected for 14 days postvaccination and serious AEs ( SAEs ) were collected for 30 days postvaccination .
METHODS	Solicited AEs included local ( pain/tenderness , swelling , nodule and redness ) and systemic ( fatigue , arthralgia and myalgia ) AEs .
METHODS	Serotype-specific immunoglobulin G ( IgG ) and opsonophagocytic ( OPA ) responses were measured immediately prior and 30 days postvaccination .
RESULTS	Incidences of local and systemic AEs were comparable across vaccine groups .
RESULTS	The majority of reported events , regardless of vaccine received , were transient and of mild to moderate intensity .
RESULTS	No clinically significant differences were observed when comparing duration and severity of AEs .
RESULTS	No vaccine-related SAEs or discontinuations from the study due to AEs were reported .
RESULTS	Pneumococcal IgG concentrations and OPA titers increased postvaccination , with appreciable fold rises for all serotypes .
RESULTS	Antibody levels were comparable between both PCV15 formulations and generally comparable to PCV7 for the shared serotypes .
CONCLUSIONS	Both formulations of PCV15 display acceptable safety profiles and induce IgG and OPA responses to all vaccine serotypes .

###24656784
BACKGROUND	The Feedback Intervention Trial was a national trial of an intervention to increase hand hygiene behavior in English and Welsh hospitals .
BACKGROUND	It significantly improved behavior , the effect increasing with fidelity to intervention , but the intervention proved more difficult to implement than anticipated .
BACKGROUND	This study aimed to identify the barriers to and facilitators of implementation as experienced by those who delivered the intervention .
METHODS	Semistructured interviews were conducted with 17 intervention ward coordinators implementing the intervention .
METHODS	Interview questions were based on the Theoretical Domains Framework .
METHODS	Text relating to each domain was scored according to whether it indicated low or high likelihood of implementation , and thematic analysis conducted .
RESULTS	The lowest scoring domains were `` environmental context and resources , '' `` beliefs about capabilities , '' `` social influences , '' and `` emotion . ''
RESULTS	Lack of time and understaffing , perceived negativity from other staff members , and stress were identified as challenges to implementation .
RESULTS	The highest scoring domains were `` behavioral regulation , '' `` motivation , '' `` skills , '' `` knowledge , '' and `` professional role . ''
RESULTS	Ward coordinators reported that they had the skills , understanding , and motivation to implement the intervention and spoke of consistency of tasks with existing roles .
CONCLUSIONS	Implementation might be improved by giving designated time for intervention tasks and ensuring that the ward coordinator role is allocated to staff for whom tasks are commensurate with existing professional roles .

###24691494
BACKGROUND	Up to 50 % of patients with schizophrenia are non-adherent with antipsychotic medication .
OBJECTIVE	To establish the efficacy of adherence therapy ( AT ) compared to treatment as usual ( TAU ) in improving clinical outcomes in patients with schizophrenia following an acute exacerbation of illness .
METHODS	A parallel-group , single-blind , randomised controlled trial .
METHODS	Fieldwork was conducted in Thailand .
METHODS	Patients received eight weekly sessions of AT in addition to TAU .
METHODS	The primary outcome was improvement in psychopathology ( measured using the Positive and Negative Syndrome Scale ( PANSS ) ) at 26-week follow-up .
METHODS	Secondary outcomes included patient attitudes towards medication , global functioning and side-effects .
RESULTS	In total , 70 inpatients with schizophrenia were recruited to the trial .
RESULTS	At 26-week follow-up , PANSS total scores improved in the AT compared to the TAU group by a mean of -3.94 points ( effect size = 0.24 ) .
RESULTS	The number needed to treat ( NNT ) was 5 .
RESULTS	There was no significant effect on patients ' attitudes towards treatment , functioning or medication side-effects .
RESULTS	No treatment-related adverse effects were reported .
CONCLUSIONS	AT improves psychopathology in Asian patients with schizophrenia following an acute exacerbation of illness .

###25495134
OBJECTIVE	To assess the long-term safety of the single-tablet combination of ibuprofen 800mg and famotidine 26.6 mg .
METHODS	A phase 3b open-label study ( NCT00984815 ) was conducted in 86 adults requiring daily non-steroidal anti-inflammatory drug ( NSAID ) administration for 12 months .
METHODS	The combination tablet of ibuprofen/famotidine was self-administered orally three times daily for up to 54 consecutive weeks .
METHODS	Adverse events ( AEs ) were collected beginning at the first dose and continued through completion ( 54 weeks ) .
METHODS	The Severity of Dyspepsia Assessment ( SODA ) questionnaire was completed by patients to assess tolerability .
RESULTS	Most patients ( 65 % ) finished the trial , with 76 % contributing data at 6 months , and 21 % withdrew due to adverse effects .
RESULTS	Overall and gastrointestinal AE discontinuation rates ( 21 % and 13 % , respectively ) were lower than that previously reported with ibuprofen 2400mg given alone .
RESULTS	Each of the SODA subscale scores demonstrated improvement by week 6 and improved statistically significantly at week 24 and week 54 .
RESULTS	Of the cardiovascular AEs , hypertension was reported most frequently ( 9/86 , 9.3 % ) , with 3.5 % determined to be drug related .
RESULTS	Twelve serious AEs were reported by 9 of 86 ( 10 % ) patients ; two were considered possibly related to the study medication ( unstable angina and gastric ulcer ) .
RESULTS	There were no reports of serious gastrointestinal or CV complications .
RESULTS	Most AEs were mild or moderate in severity and not considered drug related .
CONCLUSIONS	These data , together with previously reported findings of a significant decrease in upper gastrointestinal endoscopic ulcer rate at 6 months , support the overall safety , compliance , and tolerability of this single-tablet formulation .

###25454175
OBJECTIVE	To evaluate the effect of adjuvant chemotherapy ( ACT ) in locally advanced rectal cancer ( LARC ) after neoadjuvant chemoradiation ( NACT-RT ) .
OBJECTIVE	The study was funded by the Italian National Research Council ( CNR ) .
METHODS	From September 1992 to January 2001 , 655 patients with LARC ( clinically T3-4 , any N ) treated with NACT-RT and surgery , were randomized in two arms : follow-up ( Arm A ) or 6 cycles of ACT with 5 fluorouracil ( 5FU ) - Folinic Acid ( Arm B ) .
METHODS	NACT-RT consisted of 45Gy/28/ff concurrent with 5FU ( 350mg/sqm ) and Folinic Acid ( 20mg/sqm ) on days 1-5 and 29-33 ; surgery was performed after 4-6weeks .
METHODS	Median follow up was 637months .
METHODS	Primary end point was overall survival ( OS ) .
RESULTS	634/655 patients were evaluable ( Arm A 310 , Arm B 324 ) ; 925 % of Arm A and 91 % of Arm B patients received the preoperative treatment as in the protocol ; 294 patients of Arm A ( 948 % ) and 296 of Arm B ( 913 % ) underwent a radical resection ; complete pathologic response and overall downstaging rates did not show any significant difference in the two arms .
RESULTS	83/297 ( 28 % ) patients in Arm B , never started ACT .
RESULTS	Five year OS and DFS did not show any significant difference in the two treatment arms .
RESULTS	Distant metastases occurred in 62 patients ( 21 % ) in Arm A and in 58 ( 196 % ) in Arm B.
CONCLUSIONS	In patients with LARC treated with NACT-RT , the addition of ACT did not improve 5year OS and DFS and had no impact on the distant metastasis rate .

###24686885
BACKGROUND	There is little evidence to inform the targeted treatment of individuals found early in the diabetes disease trajectory .
OBJECTIVE	To describe cardiovascular disease ( CVD ) risk profiles and treatment of individual CVD risk factors by modelled CVD risk at diagnosis ; changes in treatment , modelled CVD risk , and CVD risk factors in the 5 years following diagnosis ; and how these are patterned by socioeconomic status .
METHODS	Cohort analysis of a cluster-randomised trial ( ADDITION-Europe ) in general practices in Denmark , England , and the Netherlands .
METHODS	A total of 2418 individuals with screen-detected diabetes were divided into quartiles of modelled 10-year CVD risk at diagnosis .
METHODS	Changes in treatment , modelled CVD risk , and CVD risk factors were assessed at 5 years .
RESULTS	The largest reductions in risk factors and modelled CVD risk were seen in participants who were in the highest quartile of modelled risk at baseline , suggesting that treatment was offered appropriately .
RESULTS	Participants in the lowest quartile of risk at baseline had very similar levels of modelled CVD risk at 5 years and showed the least variation in change in modelled risk .
RESULTS	No association was found between socioeconomic status and changes in CVD risk factors , suggesting that treatment was equitable .
CONCLUSIONS	Diabetes management requires setting of individualised attainable targets .
CONCLUSIONS	This analysis provides a reference point for patients , clinicians , and policymakers when considering goals for changes in risk factors early in the course of the disease that account for the diverse cardiometabolic profile present in individuals who are newly diagnosed with type 2 diabetes .

###24583055
BACKGROUND	Chronic subclinical volume overload happens very frequently in hemodialysis patients and is associated directly with hypertension , increased arterial stiffness , left ventricular hypertrophy , and ultimately higher mortality .
METHODS	Randomized controlled parallel-group trial .
METHODS	131 patients from one hemodialysis center , randomly assigned into 2 groups .
METHODS	Dry weight prescription using results derived from repeated 3-month bioimpedance measurements to guide ultrafiltration for strict volume control ( bioimpedance group ; n = 62 ) compared with clinical judgment without bioimpedance measures ( clinical-methods group ; n = 69 ) for 2.5 years .
RESULTS	The primary outcome was all-cause mortality over 2.5 years ( the duration of the intervention ) .
RESULTS	Secondary outcomes were change in relative arterial stiffness , fluid overload , and blood pressure ( BP ) over 2.5 years .
METHODS	Bioimpedance measurements were performed using a Body Composition Monitor device .
METHODS	Pulse wave velocity analysis was performed at baseline , 2.5 years ( end of intervention ) , and 3.5 years ( end of study ) .
METHODS	Relative fluid overload and BP were assessed at 3-month intervals .
RESULTS	The unadjusted HR for all-cause death in the bioimpedance group ( vs the clinical-methods group ) was 0.100 ( 95 % CI , 0.013-0 .805 ; P = 0.03 ) .
RESULTS	After 2.5 years , we found a greater decline in arterial stiffness , relative fluid overload , and systolic BP in the bioimpedance group than the clinical-methods group .
RESULTS	Between-group differences in change from baseline to the end of intervention were-2 .78 ( 95 % CI,-3 .75 to 1.80 ) m/s for pulse wave velocity ( P < 0.001 ) , -2.99 % ( 95 % CI,-5 .00 % to-0 .89 % ) for relative fluid overload ( P = 0.05 ) , and-2 .43 ( 95 % CI,-7 .70 to 2.84 ) mmHg for systolic BP ( P = 0.4 ) .
CONCLUSIONS	Echocardiography was not performed as cardiovascular assessment and the caregivers were not masked to the intervention .
CONCLUSIONS	Our study showed improvement in both surrogate and hard end points after strict volume control using bioimpedance to guide dry weight adjustment .
CONCLUSIONS	These findings need to be confirmed in a larger trial .

###25212080
BACKGROUND	The efficacy of non-adjuvanted seasonal influenza vaccine in young children is considered to be suboptimal .
BACKGROUND	This study compared the safety and immunogenicity profiles of MF59-adjuvanted , trivalent , influenza vaccine ( ATIV ) and non-adjuvanted , trivalent , influenza vaccine ( TIV ) in Guatemalan children ( N = 360 ) between 6 and < 60 months of age .
METHODS	Children received two doses of ATIV or TIV administered four weeks apart .
METHODS	Solicited adverse reactions were recorded for seven days after each vaccination .
METHODS	Serious adverse events were recorded throughout the entire study period .
METHODS	Antibody responses were assessed by hemagglutination inhibition ( HI ) assay at baseline , four weeks after administration of the first vaccine dose , and three weeks after administration of the second dose .
RESULTS	Both ATIV and TIV were well tolerated , with similar rates of solicited reactions and adverse events observed in response to both vaccines .
RESULTS	MF59-adjuvanted vaccine induced considerably higher antibody titers than did TIV .
RESULTS	After two doses , the B strain-specific antibody response to TIV was insufficient to meet the Center for Biologics Evaluation and Research ( CBER ) licensure criterion for seroprotection , whereas responses to the MF59-adjuvanted vaccine met the seroprotection criterion against all three strains .
RESULTS	Cross-reactive antibody responses to MF59-adjuvanted vaccine met the CBER seroprotection criterion against all three strains after two doses ; B strain-specific heterologous responses to non-adjuvanted TIV were inadequate .
CONCLUSIONS	The MF59-adjuvanted seasonal influenza vaccine was well-tolerated and highly immunogenic in children 6 to < 60 months of age , inducing seroprotective antibody titers against both the vaccine strains and antigenically distinct heterologous strains .

###24968985
OBJECTIVE	The authors compared the efficacy and tolerability of low and moderate dosages of extended-release quetiapine in adults with borderline personality disorder .
METHODS	Ninety-five participants with DSM-IV borderline personality disorder were randomly assigned to receive 150 mg/day of quetiapine ( the low-dosage group ; N = 33 ) , 300 mg/day of quetiapine ( the moderate-dosage group ; N = 33 ) , or placebo ( N = 29 ) .
METHODS	Total score over time on the clinician-rated Zanarini Rating Scale for Borderline Personality Disorder ( `` Zanarini scale '' ) was analyzed in a mixed-effects model accounting for informative dropout .
RESULTS	Participants in the low-dosage quetiapine group had significant improvement on the Zanarini scale compared with those in the placebo group .
RESULTS	Time to response ( defined as a reduction of 50 % or more on the Zanarini scale total score ) was significantly shorter for both the low-dosage quetiapine group ( hazard ratio = 2.54 , p = 0.007 ) and the moderate-dosage quetiapine group ( hazard ratio = 2.37 , p = 0.011 ) than for the placebo group .
RESULTS	Among participants who completed the study , 82 % in the low-dosage quetiapine group were rated as `` responders , '' compared with 74 % in the moderate-dosage group and 48 % in the placebo group .
RESULTS	Treatment-emergent adverse events included sedation , change in appetite , and dry mouth .
RESULTS	The overall completion rate for the 8-week double-blind treatment phase was 67 % ( 67 % for the low-dosage quetiapine group , 58 % for the moderate-dosage quetiapine group , and 79 % for the placebo group ) .
RESULTS	Participants who experienced sedation were more likely to drop out .
CONCLUSIONS	Participants treated with 150 mg/day of quetiapine had a significant reduction in the severity of borderline personality disorder symptoms compared with those who received placebo .
CONCLUSIONS	Adverse events were more likely in participants taking 300 mg/day of quetiapine .

###25514490
BACKGROUND	This study evaluates if there is any benefit of adding epinephrine to lidocaine in patients undergoing diagnostic rigid nasal endoscopy .
BACKGROUND	A prospective , randomized , double-blinded study was performed .
METHODS	Seventy patients were randomized to receive either 2 % lidocaine or 2 % lidocaine with 0.2 % epinephrine before rigid nasal endoscopy examination .
METHODS	Patients were asked to report the intensity of pain and discomfort they experienced using visual analog scale .
METHODS	An endoscopist recorded the ease to perform the procedure using the same scale .
METHODS	Intranasal structures visualized were also reported .
RESULTS	There were no significant differences in pain , discomfort or ease of exam , or in the percentage of visualized nasal structures between the two groups .
RESULTS	In the whole series , there were no significant differences in the studied variables based on gender or indication to perform endoscopy .
CONCLUSIONS	Adding epinephrine to lidocaine has no advantages in patients undergoing diagnostic rigid nasal endoscopy .

###24783925
OBJECTIVE	To compare the effects of a Chinese herbal suppository ( Jianpi suppository ) and Western Medicine ( mesalazine ) on hemorheology and CD62p in patients with ulcerative colitis ( UC ) .
METHODS	In a randomized trial , 120 mild to moderate UC patients were randomly divided into two equal groups .
METHODS	The Jianpi suppository group used Chinese herbal suppository rectally , while the mesalazine group was treated with mesalazine tablets orally .
METHODS	Two 15-day courses of treatment were carried out in both groups .
METHODS	Changes in the hemorheology and CD62p indices in patients were observed .
RESULTS	The hemorheology and CD62p indices in the Jianpi suppository group decreased significantly more than those of the mesalazine group .
CONCLUSIONS	Jianpi suppository is effective in improving the hypercoagulability of UC patients , and therefore may be worth using in clinical practice .

###24356320
OBJECTIVE	This study assessed the validity and usefulness of the Bayley Scales of Infant and Toddler Development , Third Edition ( Bayley-III ) Low Motor/Vision accommodated version .
OBJECTIVE	Accommodations are adaptations to minimize impairment bias , without altering what the test measures .
OBJECTIVE	Of the items , 66 % have Low Motor accommodations like enlarged materials ; 62 % have Low Vision accommodations .
METHODS	Using a within-subject design , we tested 19 children with the accommodated and standard Bayley-III , in a randomly counterbalanced order .
METHODS	The children had motor and/or visual impairment and a chronological age between 22 and 90 months .
METHODS	The test administrators completed an evaluation form .
RESULTS	A subgroup of children benefited from the accommodations ; 2 children obtained a large raw score difference .
RESULTS	Test administrators considered the accommodations as practical , and advantageous for most children .
CONCLUSIONS	The Low Motor/Vision accommodated version seems to validly assess the development of this population .
CONCLUSIONS	Future , larger-scale research should study whether the accommodations improve the construct validity of the Bayley-III .

###25113414
OBJECTIVE	Fibroblast growth factor 23 ( FGF23 ) and Klotho are associated with vascular calcification and cardiovascular disease in dialysis patients .
OBJECTIVE	Sevelamer has been shown to reduce progression of vascular calcification .
OBJECTIVE	This study aimed to determine the long-term effect of sevelamer treatment on serum FGF23 and Klotho levels in chronic haemodialysis ( HD ) patients .
METHODS	In the post-hoc analysis , we measured serum FGF23 , Klotho and other biochemical factors ( Ca , P , i-PTH , hsCRP , LDL-C ) in 50 haemodialysis patients , who completed a 48-week , open-Label , controlled randomized parallel-group study .
METHODS	Twenty-three patients received sevelamer and 27 patients received calcium carbonate .
RESULTS	After 48-week sevelamer treatment , there were significant changes with lower LDL-C ( from 2.820.78 to 1.650.53 mmol/L , P = 0.000 ) , lower FGF23 ( from 2465.97 ( 2568.88 ) to 795.61 ( 1098.39 ) , P = 0.000 ) and higher s-Klotho levels ( from 189.35 ( 161.88 ) to 252.94 ( 517.80 ) pg/mL , P = 0.000 ) .
RESULTS	In calcium carbonate group , there were no significant changes of LDL-C and FGF23 , but with a borderline significant increase of s-Klotho level ( from 142.34 ( 265.24 ) to 188.57 ( 252.38 ) pg/mL , P = 0.054 ) .
RESULTS	Multivariate analysis showed that FGF23 decrement was associated with sevelamer treatment ( = -0.277 , P = 0.005 ) , change of serum phosphate ( = 0.609 , P = 0.000 ) and calcium levels ( = 0.635 , P = 0.000 ) .
RESULTS	The increase of serum Klotho was associated with the decrease of serum phosphate ( = 0.490 , P = 0.019 ) .
CONCLUSIONS	Maintenance HD patients had lower serum FGF23 levels , accompanied with significantly increased serum Klotho levels , after 48-week sevelamer treatment .
CONCLUSIONS	The FGF23 decrement was associated with sevelamer use , the change of serum phosphate and calcium levels .
CONCLUSIONS	The serum Klotho increment was proportional to the phosphate-lowering power of the binders .

###26356395
OBJECTIVE	To compare the efficacy and tolerability of monotherapy with phenazepam to complex treatment with the peptide preparation selank and phenazepam in patients with anxiety disorders .
METHODS	Authors explored the anxiolytic effect and tolerability of monotherapy with phenazepam ( 30 patients ) and complex treatment with selank and phenazepam ( 40 patients ) in anxiety-phobic , hypochondriac and somatoform disorders ( ICD-10 items F40.2-9 , F41.1-9 , F45.0-2 ) .
METHODS	Therapeutic effect was assessed clinically and with HDRS , CGI and Spilberger scales .
METHODS	Tolerability was evaluated using the UKU scale .
METHODS	Stroop test and verbal fluency test were used .
METHODS	Quality of life was assessed with the SF-36 .
RESULTS	The positive effect of phenazepam was achieved earlier in the optimization of treatment with selank on HDRS .
RESULTS	The combined treatment decreased the level of undesirable side-effects of phenazepam ( attention and memory impairment , asthenia , sedation , increase in sleep duration , sexual disturbances , emotional indifference and orthostatism ) during the course of treatment and after the tranquilizer withdrawal .
RESULTS	Taken together , the therapeutic efficacy and reduction of side-effects had a positive impact on the quality-of-life of the patients treated with selank as add-on to phenazepam .
CONCLUSIONS	The results extend therapeutic possibilities of treatment of anxietyspectrum disorders with the combination of benzodiazepine tranquilizers and selank .

###25550062
OBJECTIVE	This study aimed to evaluate the long-term effects on glycemic control of a diabetes care program focusing on case management and to discuss challenges in the quality of diabetes care in Taiwan .
METHODS	We randomized 1,060 study subjects recruited from the Diabetes Management through an Integrated Delivery System project in 2003-2005 into intervention ( n = 789 from 27 clinics ) and control ( n = 271 from 7 clinics ) groups .
METHODS	The quarterly self-care and nutrition-education program in the intervention group was delivered by case managers , and standard care was provided to the control group .
METHODS	The intervention program was conducted during 2003-2007 .
METHODS	A multivariate mixed model analysis was used to assess the 3.5-year intervention effects on glycemic control .
RESULTS	Glycated hemoglobin ( HbA1c ) level in the intervention group ( especially for those with a baseline HbA1c level of 7-9 % and > 9 % ) was significantly lower than that in the control group 6 months after recruitment and remained lower through the subsequent three intervention years .
CONCLUSIONS	The current findings provide evidence that case management provided in the pay-for-performance ( P4P ) diabetes care program in Taiwan was effective at improving glycemic control for at least 3 years .
CONCLUSIONS	However , previous research indicated poverty is associated with not only higher diabetes incidence but also inequality of diabetes care in Taiwan despite universal health coverage .
CONCLUSIONS	Those with a more severe condition were less likely to be enrolled in the P4P diabetes care program .
CONCLUSIONS	Additional cost-effectiveness studies and more health policy reforms are needed to optimize diabetes care in Taiwan .

###25201932
OBJECTIVE	The goal of this study was to assess the effects of training primary care providers ( PCPs ) to use Motivational Interviewing ( MI ) when treating depressed patients on providers ' MI performance and patients ' expressions of interest in depression treatment ( `` change talk '' ) and short-term treatment adherence .
METHODS	This was a cluster randomized trial in urban primary care clinics ( 3 intervention , 4 control ) .
METHODS	We recruited 21 PCPs ( 10 intervention , 11 control ) and 171 English-speaking patients with newly diagnosed depression ( 85 intervention , 86 control ) .
METHODS	MI training included a baseline and up to 2 refresher classroom trainings , along with feedback on audiotaped patient encounters .
METHODS	We report summary measures of technical ( rate of MI-consistent statements per 10 minutes during encounters ) and relational ( global rating of `` MI Spirit '' ) MI performance , the association between MI performance and number of MI trainings attended ( 0 , 1 , 2 , or 3 ) , and rates of patient change talk regarding depression treatments ( physical activity , antidepressant medication ) .
METHODS	We report PCP use of physical activity recommendations and antidepressant prescriptions and patients ' short-term physical activity level and prescription fill rates .
RESULTS	Use of MI-consistent statements was 26 % higher for MI-trained versus control PCPs ( P = .005 ) .
RESULTS	PCPs attending all 3 MI trainings ( n = 6 ) had 38 % higher use of MI-consistent statements ( P < .001 ) and were over 5 times more likely to show beginning proficiency in MI Spirit ( P = .036 ) relative to control PCPs .
RESULTS	Although PCPs ' use of physical activity recommendations and antidepressant prescriptions was not significantly different by randomization arm , patients seen by MI-trained PCPs had more frequent change talk ( P = .001 ) .
RESULTS	Patients of MI-trained PCPs also expressed change talk about physical activity 3 times more frequently ( P = .01 ) and reported more physical activity ( 3.05 vs 1.84 days in the week after the visit ; P = .007 ) than their counterparts visiting untrained PCPs .
RESULTS	Change talk about antidepressant medication and fill rates were similar by randomization arm ( P > .05 for both ) .
CONCLUSIONS	MI training resulted in improved MI performance , more depression-related patient change talk , and better short-term adherence .

###24630419
BACKGROUND	Radical cystectomy ( RC ) for bladder cancer is frequently associated with delayed gastrointestinal ( GI ) recovery that prolongs hospital length of stay ( LOS ) .
OBJECTIVE	To assess the efficacy of alvimopan to accelerate GI recovery after RC .
METHODS	We conducted a randomized double-blind placebo-controlled trial in patients undergoing RC and receiving postoperative intravenous patient-controlled opioid analgesics .
METHODS	Oral alvimopan 12 mg ( maximum : 15 inpatient doses ) versus placebo .
METHODS	The two-component primary end point was time to upper ( first tolerance of solid food ) and lower ( first bowel movement ) GI recovery ( GI-2 ) .
METHODS	Time to discharge order written , postoperative LOS , postoperative ileus ( POI ) - related morbidity , opioid consumption , and adverse events ( AEs ) were evaluated .
METHODS	An independent adjudication of cardiovascular AEs was performed .
CONCLUSIONS	Patients were randomized to alvimopan ( n = 143 ) or placebo ( n = 137 ) ; 277 patients were included in the modified intention-to-treat population .
CONCLUSIONS	The alvimopan cohort experienced quicker GI-2 recovery ( 5.5 vs 6.8 d ; hazard ratio : 1.8 ; p < 0.0001 ) , shorter mean LOS ( 7.4 vs 10.1 d ; p = 0.0051 ) , and fewer episodes of POI-related morbidity ( 8.4 % vs 29.1 % ; p < 0.001 ) .
CONCLUSIONS	The incidence of opioid consumption and AEs or serious AEs ( SAEs ) was comparable except for POI , which was lower in the alvimopan group ( AEs : 7 % vs 26 % ; SAEs : 5 % vs 20 % , respectively ) .
CONCLUSIONS	Cardiovascular AEs occurred in 8.4 % ( alvimopan ) and 15.3 % ( placebo ) of patients ( p = 0.09 ) .
CONCLUSIONS	Generalizability may be limited due to the exclusion of epidural analgesia and the inclusion of mostly high-volume centers utilizing open laparotomy .
CONCLUSIONS	Alvimopan is a useful addition to a standardized care pathway in patients undergoing RC by accelerating GI recovery and shortening LOS , with a safety profile similar to placebo .
RESULTS	This study examined the effects of alvimopan on bowel recovery in patients undergoing radical cystectomy for bladder cancer .
RESULTS	Patients receiving alvimopan experienced quicker bowel recovery and had a shorter hospital stay compared with those who received placebo , with comparable safety .
BACKGROUND	ClinicalTrials.gov identifier NCT00708201 .

###24584065
OBJECTIVE	To evaluate the effect of 1 ) patient values as expressed by family members and 2 ) a requirement to document patients ' functional prognosis on intensivists ' intention to discuss withdrawal of life support in a hypothetical family meeting .
METHODS	A three-armed , randomized trial .
METHODS	One hundred seventy-nine U.S. hospitals with training programs in critical care accredited by the Accreditation Council for Graduate Medical Education .
METHODS	Six hundred thirty intensivists recruited via e-mail invitation from a database of 1,850 eligible academic intensivists .
METHODS	Each intensivist was randomized to review 10 , online , clinical scenarios with a range of illness severities involving a hypothetical patient ( Mrs. X ) .
METHODS	In control-group scenarios , the patient did not want continued life support without a reasonable chance of independent living .
METHODS	In the first experimental arm , the patient wanted life support regardless of functional outcome .
METHODS	In the second experimental arm , patient values were identical to the control group , but intensivists were required to record the patient 's estimated 3-month functional prognosis .
RESULTS	Response to the question : `` Would you bring up the possibility of withdrawing life support with Mrs. X 's family ? ''
RESULTS	answered using a five-point Likert scale .
RESULTS	There was no effect of patient values on whether intensivists intended to discuss withdrawal of life support ( p = 0.81 ) , but intensivists randomized to record functional prognosis were 49 % more likely ( 95 % CI , 20-85 % ) to discuss withdrawal .
CONCLUSIONS	In this national , scenario-based , randomized trial , patient values had no effect on intensivists ' decisions to discuss withdrawal of life support with family .
CONCLUSIONS	However , requiring intensivists to record patients ' estimated 3-month functional outcome substantially increased their intention to discuss withdrawal .

###25713015
OBJECTIVE	To determine women 's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour .
METHODS	Multicentre randomised controlled equivalence trial .
METHODS	15 hospitals in the Netherlands .
METHODS	Women with an intermediate to high obstetric risk with an intention to deliver vaginally .
METHODS	To exclude a clinically relevant difference in satisfaction with pain relief of more than 10 % , we needed to include 1136 women .
METHODS	Because of missing values for satisfaction this number was increased to 1400 before any analysis .
METHODS	We used multiple imputation to correct for missing data .
METHODS	Before the onset of active labour consenting women were randomised to a pain relief strategy with patient controlled remifentanil or epidural analgesia if they requested pain relief during labour .
METHODS	Primary outcome was satisfaction with pain relief , measured hourly on a visual analogue scale and expressed as area under the curve ( AUC ) , thus providing a time weighted measure of total satisfaction with pain relief .
METHODS	A higher AUC represents higher satisfaction with pain relief .
METHODS	Secondary outcomes were pain intensity scores , mode of delivery , and maternal and neonatal outcomes .
METHODS	Analysis was done by intention to treat .
METHODS	The study was defined as an equivalence study for the primary outcome .
RESULTS	1414 women were randomised , of whom 709 were allocated to patient controlled remifentanil and 705 to epidural analgesia .
RESULTS	Baseline characteristics were comparable .
RESULTS	Pain relief was ultimately used in 65 % ( 447/687 ) in the remifentanil group and 52 % ( 347/671 ) in the epidural analgesia group ( relative risk 1.32 , 95 % confidence interval 1.18 to 1.48 ) .
RESULTS	Cross over occurred in 7 % ( 45/687 ) and 8 % ( 51/671 ) of women , respectively .
RESULTS	Of women primarily treated with remifentanil , 13 % ( 53/402 ) converted to epidural analgesia , while in women primarily treated with epidural analgesia 1 % ( 3/296 ) converted to remifentanil .
RESULTS	The area under the curve for total satisfaction with pain relief was 30.9 in the remifentanil group versus 33.7 in the epidural analgesia group ( mean difference -2.8 , 95 % confidence interval -6.9 to 1.3 ) .
RESULTS	For who actually received pain relief the area under the curve for satisfaction with pain relief after the start of pain relief was 25.6 in the remifentanil group versus 36.1 in the epidural analgesia group ( mean difference -10.4 , -13.9 to -7.0 ) .
RESULTS	The rate of caesarean section was 15 % in both groups .
RESULTS	Oxygen saturation was significantly lower ( SpO2 < 92 % ) in women who used remifentanil ( relative risk 1.5 , 1.4 to 1.7 ) .
RESULTS	Maternal and neonatal outcomes were comparable between both groups .
CONCLUSIONS	In women in labour , patient controlled analgesia with remifentanil is not equivalent to epidural analgesia with respect to scores on satisfaction with pain relief .
CONCLUSIONS	Satisfaction with pain relief was significantly higher in women who were allocated to and received epidural analgesia .
BACKGROUND	Netherlands Trial Register NTR2551 .

###24423155
BACKGROUND	TTP488 , an antagonist at the Receptor for Advanced Glycation End products , was evaluated as a potential treatment for patients with mild-to-moderate Alzheimer 's disease ( AD ) .
BACKGROUND	A previous report describes decreased decline in ADAS-cog ( delta = 3.1 , p = 0.008 at 18 months , ANCOVA with multiple imputation ) , relative to placebo , following a 5 mg/day dose of TTP488 .
BACKGROUND	Acute , reversible cognitive worsening was seen with a 20 mg/day dose .
BACKGROUND	The present study further evaluates the efficacy of TTP488 by subgroup analyses based on disease severity and concentration effect analysis .
METHODS	399 patients were randomized to one of two oral TTP488 doses ( 60 mg for 6 days followed by 20 mg/day ; 15 mg for 6 days followed by 5 mg/day ) or placebo for 18 months .
METHODS	Pre-specified primary analysis , using an ITT population , was on the ADAS-cog11 .
METHODS	Secondary analyses included as a key secondary variable the Clinical Dementia Rating-Sum of Boxes ( CDR-SB ) , and another secondary variable of the ADCS-ADL .
RESULTS	On-treatment analysis demonstrated numerical differences favoring 5 mg/day over placebo , with nominal significance at Month 18 ( delta = 2.7 , p = 0.03 ) .
RESULTS	Patients with mild AD , whether defined by MMSE or ADAS-cog , demonstrated significant differences favoring 5 mg/day on ADAS-cog and trends on CDR-sb and ADCS-ADL at Month 18 .
RESULTS	TTP488 plasma concentrations of 7.6-16 .8 ng/mL were associated with a decreased decline in ADAS-cog over time compared to placebo .
RESULTS	Worsening on the ADAS-cog relative to placebo was evident at 46.8-167 .0 ng/mL .
CONCLUSIONS	Results of these analyses support further investigation of 5 mg/day in future Phase 3 trials in patients with mild AD .

###24406481
OBJECTIVE	The Sibutramine Cardiovascular OUTcomes ( SCOUT ) trial showed a significantly increased relative risk of nonfatal cardiovascular events , but not mortality , in overweight and obese subjects receiving long-term sibutramine treatment with diet and exercise .
OBJECTIVE	We examined the relationship between early changes ( both increases and decreases ) in body weight and blood pressure , and the impact of these changes on subsequent cardiovascular outcome events .
METHODS	A total of 9804 male and female subjects , aged 55 years or older , with a body mass index of 27-45kgm ( -2 ) were included in this current subanalysis of the SCOUT trial .
METHODS	Subjects were required to have a history of cardiovascular disease and/or type 2 diabetes mellitus with at least one cardiovascular risk factor ( hypertension , dyslipidemia , current smoking or diabetic nephropathy ) to assess cardiovascular outcomes .
METHODS	Post hoc subgroup analyses of weight change ( categories ) and blood pressure were performed overall and by treatment group ( 6-week sibutramine followed by randomized placebo or continued sibutramine ) .
METHODS	The primary outcome event ( POE ) was a composite of nonfatal myocardial infarction , nonfatal stroke , resuscitated cardiac arrest or cardiovascular death .
METHODS	Time-to-event analyses of the POE were performed using Cox regression models with factors for treatment , subgroups and interactions .
RESULTS	During the initial 6-week sibutramine treatment period , systolic blood pressure decreased progressively with increasing weight loss in hypertensive subjects ( -8.110.5 mmHg with < 5kg weight loss to -10.811.0 mmHg with 5kg weight loss ) .
RESULTS	The highest POE incidence occurred mainly in groups with increases in both weight and blood pressure .
RESULTS	However , with long-term sibutramine treatment , a markedly lower blood pressure tended to increase POEs .
CONCLUSIONS	Modest weight loss and modest lower blood pressure each reduced the incidence of cardiovascular events , as expected .
CONCLUSIONS	However , the combination of early marked weight loss and rapid blood pressure reduction seems to be harmful in this obese elderly cardiovascular diseased population .

###25141962
BACKGROUND	Breast neoplasms are the second most common type of cancer worldwide , and radiation therapy is a key component of their treatment .
BACKGROUND	Acute skin reactions are one of the most common side effects of radiation therapy , and prevention of this adverse event has been investigated in several studies .
BACKGROUND	However , a clinically applicable , preventative treatment remains unavailable .
BACKGROUND	It has been demonstrated that application of a low-power laser can promote tissue repair .
BACKGROUND	Therefore , the aim of this trial is to evaluate the effectiveness of an indium gallium aluminum phosphorus ( InGaAIP ) laser operated at 660nm in preventing radiodermatitis in women undergoing adjuvant radiotherapy for breast cancer .
METHODS	This is a two-arm , randomized controlled trial .
METHODS	A total of 52 patients undergoing radiotherapy for breast cancer ( stages I to III ) will be enrolled .
METHODS	Patients will be randomly assigned to an intervention group to receive laser therapy ( n = 26 ) or a control group to receive a placebo ( n = 26 ) .
METHODS	The laser or placebo will be applied five days a week , immediately before each radiotherapy session .
METHODS	Skin reactions will then be graded weekly by a nurse , a radiotherapist , and an oncologist ( all of whom will be blinded ) using the Common Toxicity Criteria ( CTC ) developed by the National Cancer Institute and the Acute Radiation Morbidity Scoring Criteria developed by the Radiation Therapy Oncology Group .
METHODS	Patients will also answer a modified visual analogue scale for pain ( a self-evaluation questionnaire ) .
METHODS	Primary and secondary outcomes will be the prevention of radiodermatitis and pain secondary to radiodermatitis , respectively .
CONCLUSIONS	The ideal tool for preventing radiodermatitis is an agent that mediates DNA repair or promotes cell proliferation .
CONCLUSIONS	Application of a low-power laser has been shown to promote tissue repair by reducing inflammation and inducing collagen synthesis .
CONCLUSIONS	Moreover , this treatment approach has not been associated with adverse events and is cost-effective .
CONCLUSIONS	Thus , the results of this ongoing trial may establish whether use of a low-power laser represents an ideal treatment option for the prevention of radiodermatitis .
BACKGROUND	ClinicalTrials.gov identifier : NCT02003599 .
BACKGROUND	Registered on 2 December 2013 .

###24411542
OBJECTIVE	To compare intercostal nerve block before and after rib harvest in terms of mean postoperative pain score and mean postoperative tramadol usage .
METHODS	Randomized controlled trial .
METHODS	Department of Plastic Surgery , Mayo Hospital , KEMU , Lahore , from January 2011 to July 2012 .
METHODS	Patients ( n = 120 ) of either gender with ASA class-I and II requiring autogenous costal cartilage graft were inducted .
METHODS	Patients having history of local anaesthetic hypersensitivity and age < 15 years or > 60 years were excluded .
METHODS	Subjects were randomly assigned to pre-rib harvest ( group-1 ) and post-rib harvest ( group-2 ) .
METHODS	Local anaesthetic mixture was prepared by adding 10 milliliters 2 % lidocaine to 10 milliliters 0.5 % bupivacaine to obtain a total 20 ml solution .
METHODS	Group-1 received local anaesthetic infiltration along the proposed incision lines and intercostals block before the rib harvest .
METHODS	Group-2 received the infiltration and block after rib harvest .
METHODS	Postoperative consumption of tramadol and pain scores were measured at 6 and 12 hours postoperatively using VAS .
RESULTS	Mean age was 31.43 10.78 years .
RESULTS	The mean pain scores at 6 hours postoperatively were 1.033 0.609 and 2.4667 0.812 in pre-rib harvest and post-rib harvest groups respectively ( p < 0.0001 ) .
RESULTS	The mean pain scores at 12 hours postoperatively were 1.45 0.565 and 3.65 0.633 in pre-rib harvest and post-rib harvest groups respectively ( p < 0.0001 ) .
RESULTS	The mean tramadol used postoperatively in first 24 hours was 169 29.24 mg and 255 17.70 mg in prerib harvest and post-rib harvest groups respectively ( p < 0.0001 ) .
CONCLUSIONS	Intercostal block administered before rib harvest as preemptive strategy result in decreased postoperative pain scores and narcotic use .

###24256372
OBJECTIVE	The aim of this study was assessment of subendometrial blood flow with Doppler ultrasonography as an indicator of endometrial receptivity in stimulated cycles for intrauterine insemination ( IUI ) .
METHODS	This prospective study enrolled 90 women scheduled for IUI after ovarian stimulation randomly assigned to one of the three equal groups ; group ( C ) received Clomiphene citrate , group ( H ) received HMG and group ( CH ) received Clomiphene citrate in addition to HMG .
METHODS	All participants had ultrasound folliculometry starting on day 9 , followed by transvaginal Doppler study of the subendometrial blood flow and perifollicular blood flow on the day of detecting at least one follicle > 18mm .
METHODS	Resistivity index ( RI ) and pulsatility index ( PI ) of subendometrial and perifollicular flow were measured .
METHODS	Endometrial thickness was measured on day of hCG injection .
RESULTS	Group ( H ) showed significantly higher frequency of subendometrial flow ( 80 % ) compared to the other two groups ( p = 0.009 ) .
RESULTS	In cases of positive subendometrial flow , the RI and PI were significantly lower in group ( H ) compared to the other two groups ( p = 0.007 and 0.012 , respectively ) .
RESULTS	Endometrial thickness was significantly lower in group ( C ) compared to group ( H ) ( p < 0.001 ) and group ( CH ) ( p < 0.001 ) .
RESULTS	Successful intrauterine implantation was documented in a total of 16 women ( 17.8 % ) ; the highest frequency was in group ( H ) ( 23.3 % ) and the lowest in group ( C ) , however , the difference between the three groups was not significant ( p = 0.372 ) .
RESULTS	Subendometrial indices and perifollicular RI were significantly lower in cases of successful implantation , while endometrium was significantly thicker in these cases ( p < 0.001 ) .
CONCLUSIONS	The presence of subendometrial flow is associated with successful IUI in women under stimulated cycles undergoing IUI .
CONCLUSIONS	HMG seems a superior option for induction of ovulation regarding success of implantation .

###24433817
OBJECTIVE	To determine whether a single exposure to a Manga comic ( Japanese comic art ) with multiple messages promoting fruit intake influenced snack selection in minority urban youth .
METHODS	Fifty-seven youth ( mean age 10.8 y ; 54 % female ; 74 % black/African American ) attending after-school programs in Brooklyn , NY participated in a pilot study in which they were randomly assigned to receive the comic or a non-health-related newsletter .
METHODS	After reading their media , participants were offered a snack and could choose from among healthy/unhealthy options .
METHODS	Secondary outcomes included knowledge , self-efficacy , and outcome expectations related to fruit intake and media transportation .
METHODS	Data were analyzed using regression and paired t test .
RESULTS	Comic group participants were significantly more likely to choose a healthy snack , compared to the Attention-control group ( odds ratio = 3.6 , 95 % confidence interval : 1.1-12 .1 , P = .04 ) .
RESULTS	The Comic group reported increases in self-efficacy ( P = .04 ) and greater transportation ( immersion into media ) ( P = .006 ) .
CONCLUSIONS	Results suggest Manga comics may be a useful format to promote healthy snack selection in urban minority youth .

###25044219
OBJECTIVE	Renal failure patients were treated with linezolid ( LZD ) for proven or suspected infections by multi-resistant Gram-positive cocci .
OBJECTIVE	The aim of this study was to determine if dose adjustment of LZD is needed as a function of renal impairment or not , especially that a significant component of LZD is eliminated unchanged in urine .
METHODS	The single dose pharmacokinetics of LZD was investigated .
METHODS	Eighteen non-infected male subjects with various degrees of renal impairment ranged from normal to severe chronic impairment were enrolled , including end-stage renal disease ( ESRD ) patients maintained on hemodialysis ( HD ) .
METHODS	LZD was administered as a single oral 600mg dose , and blood samples were drawn at different times and analysed by a validated HPLC assay method .
METHODS	Plasma profiles were evaluated by non-compartmental and compartmental approaches .
CONCLUSIONS	A similar rate and extent of LZD absorption and elimination and comparable body exposure was observed in both healthy subjects and acute renal failure patients .
CONCLUSIONS	The extent of LZD exposure was significantly increased by 3-fold in ESRD patients in their off-dialysis day .
CONCLUSIONS	Furthermore , the t1/2 and MRT values were significantly increased by ~ 5 - and 3-fold , respectively .
CONCLUSIONS	The Vd / F values of LZD did not change with renal function .
CONCLUSIONS	A significant decrease in CL/F by ~ 3-fold was observed in ESRD patients in their off-dialysis day however , CL/F was significantly increased by ~ 4-fold during HD .
CONCLUSIONS	Approximately half of the administered LZD dose was removed during the HD session in these selected cohorts of ESRD patients .
CONCLUSIONS	LZD was generally well tolerated .
CONCLUSIONS	The dose of LZD did not need to be adjusted for patients with acute renal dysfunction or ESRD on HD .
CONCLUSIONS	One of the twice-daily doses should be administered after the dialysis session because almost half of the LZD dose was substantially removed by HD .
CONCLUSIONS	During the first three dialysis sessions of the treatment course , to avoid potentially ineffective therapy , a supplemental dose of LZD might be given if necessary or the dose of LZD should be administered 4h before the beginning of the HD session .
CONCLUSIONS	This was to keep LZD levels above the MIC for the organism causing the infection being treated .

###24899528
BACKGROUND	Changes in diet and exercise have been separately demonstrated to improve Depression , although scientific evidence available is scarce .
BACKGROUND	In a previously published controlled study , just recommending these and other lifestyle measures ( sleep restriction and sunlight exposure ) in combination once , patients experienced improvements in their depressive symptoms six months later .
BACKGROUND	In this sample , one in three depressive patients had metabolic syndrome ( MetS ) at baseline .
BACKGROUND	First line treatment of MetS condition is hygienic-dietetic , being Mediterranean diet and exercise especially important .
BACKGROUND	Therefore we analyzed if lifestyle recommendations also improved their metabolic profile .
RESULTS	During the sixth month evaluation , a smaller number of patients from the group receiving hygienic-dietary recommendations met MetS criteria comparing with the control group .
CONCLUSIONS	This study suggests that costless lifestyle recommendations , such as exercise and Mediterranean diet , have the capacity to promote both mental and physical health in a significant proportion of depressive patients .
CONCLUSIONS	Further research is needed to confirm or discard these preliminary findings .

###24655552
OBJECTIVE	To assess the effects of oral and transdermal hormone replacement therapies ( HRT ) on levels of important cardiovascular disease ( CVD ) markers , MCP-1 and homocyteine , in the early postmenopausal period .
METHODS	Seventy-six healthy , early postmenopausal women were enrolled in the study .
METHODS	Patients were randomly assigned to receive oral or transdermal HRT for 6 months .
METHODS	The first group received continuous combined oral HRT containing 1mg 17-estradiol and 0.5 mg norethisterone acetate ( n = 39 ) , and the second group received sequential transdermal HRT releasing 50g/day estradiol alone given twice a week on days 1-14 and 50g/day estradiol plus 0.25 mg/day norethisterone acetate given twice a week on days 15-28 ( n = 37 ) .
METHODS	Circulating levels of MCP-1 and homocysteine , along with other CVD markers , were assessed before and after treatment in all patients .
RESULTS	There were no significant differences between the baseline characteristics of the two groups .
RESULTS	Baseline serum MCP-1 levels were similar between the oral and transdermal HRT groups ( 150.112.8 vs. 145.211.6 pg/ml ; P = .219 ) .
RESULTS	The mean MCP-1 levels did not change after 6 months of HRT in both oral ( 150.112.8 vs. 153.612.5 pg/ml ; P = .192 ) and transdermal HRT groups ( 145.211.6 vs. 146.115.1 pg/ml ; P = .419 ) .
RESULTS	Moreover , there was no significant difference between the groups in MCP-1 serum levels after 6 months of HRT .
RESULTS	Similarly , no difference was found in serum homocyteine levels following 6 months of HRT .
CONCLUSIONS	Both oral continuous and sequential transdermal HRTs do not have significant effects on serum MCP-1 and homocyteine levels in women during the early postmenopausal period .

###24705469
BACKGROUND	The J-ROCKET AF study found that rivaroxaban was non-inferior to warfarin with respect to the principal safety outcome in patients with atrial fibrillation ( AF ) .
BACKGROUND	The aim of this subgroup analysis was to assess the safety and efficacy of rivaroxaban and warfarin in relation to patient age .
RESULTS	A total of 39.0 % were elderly ( aged 75 years ) .
RESULTS	In elderly patients , the principal safety outcome occurred at 25.05 % / year with rivaroxaban vs. 16.95 % / year on warfarin ( hazard ratio [ HR ] , 1.49 ; 95 % confidence interval [ CI ] : 1.02-2 .16 ) , whereas the primary efficacy endpoint occurred at 2.18 % / year vs. 4.25 % / year ( HR , 0.51 ; 95 % CI : 0.20-1 .27 ) , respectively .
RESULTS	There were significant interactions in the principal safety outcomes of rivaroxaban compared with warfarin between the elderly and non-elderly groups , but not in the primary efficacy endpoints ( P = 0.04 and 0.82 for both interactions , respectively ) .
RESULTS	Furthermore , in elderly patients , in the rivaroxaban group there was a trend to increase the principal safety outcome regardless of renal function .
RESULTS	In elderly patients with preserved renal function , however , patients on rivaroxaban had a marginally favorable trend in the primary efficacy endpoint incidence rate compared with patients on warfarin .
CONCLUSIONS	There is a need to carefully consider the risks and benefits of therapy with rivaroxaban in elderly patients with non-valvular AF .

###25361220
OBJECTIVE	The study objectives were to analyze the impact of the number of lymph nodes ( LNs ) reported as resected ( NLNr ) and the number of LNs invaded ( NLNi ) on the prognosis of esophageal cancer ( EC ) after neoadjuvant chemoradiotherapy .
BACKGROUND	Pathological LN status is a major disease prognostic factor and marker of surgical quality .
BACKGROUND	The impact of neoadjuvant chemoradiation ( nCRT ) on LN status remains poorly studied in EC .
METHODS	Post hoc analysis from a phase III randomized controlled trial comparing nCRT and surgery ( group nCRT ) to surgery alone ( group S ) in stage I and II EC ( NCT00047112 ) .
METHODS	Only patients who underwent surgical resection were considered ( n = 170 ) .
RESULTS	nCRT resulted in tumoral downstaging ( pT0 , 40.7 % vs 1.1 % , P < 0.001 ) , LN downstaging ( pN0 , 69.1 % vs 47.2 % , P = 0.016 ) , and reduction in the median NLNr [ 16.0 ( range , 0-47 .0 ) vs 22.0 ( range , 3.0-58 .0 ) , P = 0.001 ] and NLNi [ 0 ( range , 0-25 ) vs 1.0 ( range , 0-25 ) , P = 0.001 ] .
RESULTS	A good histological response ( TRG1/2 ) in the resected esophageal specimen correlated with reduced median NLNi [ 0 ( range , 0-10 ) vs 1.0 ( range , 0-4 ) , P = 0.007 ] .
RESULTS	After adjustment by treatment , NLNi [ hazards ratio ( HR ) ( 1-3 vs 0 ) 3.5 , 95 % confidence interval ( CI ) : 2.3-5 .5 , and HR ( > 3 vs 0 ) 3.5 , 95 % CI : 2.0-6 .2 , P < 0.001 ] correlated with prognosis , whereas NLNr [ HR ( < 15 vs 15 ) 0.95 , 95 % CI : 0.6-1 .4 , P = 0.807 and HR ( < 23 vs 23 ) 1.4 , 95 % CI : 0.9-2 .0 , P = 0.131 ] did not .
RESULTS	In Poisson regression analysis , nCRT was an independent predictive variable for reduced NLNr [ exp ( coefficient ) 0.80 , 95 % CI : 0.66-0 .96 , P = 0.018 ] .
CONCLUSIONS	nCRT is not only responsible for disease downstaging but also predicts fewer LNs being identified after surgical resection for EC .
CONCLUSIONS	This has implications for the current quality criteria for surgical resection .

###25741159
OBJECTIVE	To compare the effects and postoperative complications between tissue selecting therapy stapler ( TST ) and Milligan-Morgan hemorrhoidectomy ( M-M ) .
METHODS	Four hundred and eighty patients with severe prolapsing hemorrhoids , who were admitted to the Shenyang Coloproctology Hospital between 2009 and 2012 , were randomly divided into observation ( n = 240 ) and control ( n = 240 ) groups .
METHODS	Hemorrhoidectomies were performed with TST in the observation group and with the M-M technique in the control group .
METHODS	The therapeutic effects , operation security , and postoperative complications in the two groups were compared .
METHODS	The immediate and long-term complications were assessed according to corresponding criteria .
METHODS	Pain was assessed on a visual analogue scale .
METHODS	The efficacy was assessed by specialized criteria .
METHODS	The follow-up was conducted one year after the operation .
RESULTS	The total effective rates of the observation and control groups were 99.5 % ( 217/218 ) and 98.6 % ( 218/221 ) respectively ; the difference was not statistically significant ( P = 0.322 ) .
RESULTS	Their were significant differences between observation and control groups in intraoperative blood loss ( 5.071.14 vs 2.450.57 , P = 0.000 ) , pain ( 12 h after the surgery : 5.081.62 vs 7.192.01 , P = 0.000 ; at first dressing change : 2.640.87 vs 4.341.15 , P = 0.000 ; first defecation : 3.911.47 vs 5.631.98 , P = 0.001 ) , urine retention ( n = 22 vs n = 47 , P = 0.001 ) , anal pendant expansion after the surgery ( 2.350.56 vs 5.161.42 , P = 0.000 ) , operation time ( 18.35.6 min vs 29.58.2 min , P = 0.000 ) , and the length of hospital stay ( 5.30.6 d vs 11.41.8 d , P = 0.000 ) .
RESULTS	Moreover TST showed significant reductions compared to M-M in the rates of long-term complications such as fecal incontinence ( n = 3 vs n = 16 , P = 0.003 ) , difficult bowel movement ( n = 1 vs n = 9 , P = 0.011 ) , intractable pain ( n = 2 vs n = 12 , P = 0.007 ) , and anal discharge ( n = 3 vs n = 23 , P = 0.000 ) .
CONCLUSIONS	TST for severe prolapsing hemorrhoids is a satisfactory technique for more rapid recovery , lower complication rates , and higher operation security .

###25193390
BACKGROUND	Transenteral ( TE ) administration of a bowel cleanser prior to colonoscopy avoids the discomfort associated with drinking a large volume of unpalatable cleanser .
OBJECTIVE	To explore patient comfort , preference for future colonoscopy , the efficacy and adverse events associated with TE bowel preparation .
METHODS	Bowel preparation is traditionally practised using polyethylene glycol ( PEG ) + ascorbic acid ( ASC ) , which was the treatment used in the control group ( peroral group ; PO group ) .
METHODS	In the study group ( TE group ) , PEG + ASC were administered directly to the third portion of the duodenum through a scope immediately after completing upper gastrointestinal endoscopy .
RESULTS	A higher proportion of subjects in the TE group graded their degree of comfort as very or rather comfortable ( 28.4 % in the PO group , 65.1 % in the TE group ; p = 0.000 ) and had greater preference for future colonoscopy ( 69.6 % in the PO group , 82.5 % in the TE group ; p = 0.030 ) , compared with the PO group .
RESULTS	The TE group had non-inferiority in efficacy compared with the PO group ( non-inferiority margin -15 % ; lower limit of 95 % confidence interval for difference between success rates -6.4 % , when using the Aronchick Scale , and -7.1 % when using the Ottawa Scale ) .
RESULTS	Nausea or vomiting were more prevalent during preparation in the PO group ( 46.1 vs. 17.5 % ; p = 0.000 ) , and dizziness was more common in the TE group ( 0 vs. 12.6 % ; p = 0.000 ) .
CONCLUSIONS	TE preparation was found to be more comfortable than the traditional peroral method and not inferior in efficacy .
CONCLUSIONS	The adverse events rate was acceptable .

###24292999
OBJECTIVE	The REbif FLEXible dosing in early MS ( REFLEX ) study compared several brain MRI outcomes in patients presenting with clinically isolated syndromes suggestive of multiple sclerosis and treated with two dose-frequencies of subcutaneous interferon ( IFN ) -1 a or placebo .
METHODS	Patients were randomised ( 1:1:1 ) to IFN -1 a , 44 g subcutaneously three times a week or once a week , or placebo three times a week for up to 24 months .
METHODS	MRI scans were performed every 3 months , or every 6 months if the patient developed clinically definite multiple sclerosis .
METHODS	End points analysed included : number of combined unique active lesions per patient per scan ; numbers and volumes of new T2 , T1 hypointense and gadolinium-enhancing ( Gd + ) lesions per patient per scan ; and brain volume .
RESULTS	517 patients were randomised ( intent-to-treat population : subcutaneous IFN -1 a three times a week , n = 171 ; subcutaneous IFN -1 a once a week , n = 175 ; placebo , n = 171 ) .
RESULTS	Combined unique active lesions were lower in patients treated with subcutaneous IFN -1 a versus placebo ( mean ( SD ) lesions per patient per scan : three times a week 0.6 ( 1.15 ) ; once a week 1.23 ( 4.26 ) ; placebo 2.70 ( 5.23 ) ; reduction versus placebo : three times a week 81 % ; once a week 63 % ; p < 0.001 ) and with three times a week versus once a week ( 48 % reduction ; p = 0.002 ) .
RESULTS	The mean numbers of new T2 , T1 hypointense and Gd + lesions were all significantly lower in the two active treatment arms compared with placebo ( p0 .004 for three times a week or once a week ) and in the three times a week group compared with once a week ( p0 .012 ) .
CONCLUSIONS	Both subcutaneous IFN -1 a 44 g regimens improved MRI outcomes versus placebo , with the three times a week regimen having a more pronounced effect than once a week dosing .
BACKGROUND	clinicaltrial.gov identifier , NCT00404352 .

###24595630
OBJECTIVE	Adjunctive-to-insulin therapy with sodium-glucose cotransporter 2 ( SGLT2 ) inhibition may improve glycemic control in type 1 diabetes ( T1D ) .
METHODS	We evaluated the glycemic efficacy and safety of empagliflozin 25 mg daily in 40 patients treated for 8 weeks in a single-arm open-label proof-of-concept trial ( NCT01392560 ) .
RESULTS	Mean A1C decreased from 8.0 0.9 % ( 64 10 mmol/mol ) to 7.6 0.9 % ( 60 10 mmol/mol ) ( P < 0.0001 ) , fasting glucose from 9.0 4.3 to 7.0 3.2 mmol/L ( P = 0.008 ) , symptomatic hypoglycemia ( < 3.0 mmol/L ) from 0.12 to 0.04 events per patient per day ( P = 0.0004 ) , and daily insulin dose from 54.7 20.4 to 45.8 18.8 units/day ( P < 0.0001 ) .
RESULTS	Mean urinary excretion of glucose increased from 19 19 to 134 61 g/day ( P < 0.0001 ) .
RESULTS	Weight decreased from 72.6 12.7 to 70.0 12.3 kg ( P < 0.0001 ) , and waist circumference decreased from 82.9 8.7 to 79.1 8.0 cm ( P < 0.0001 ) .
CONCLUSIONS	This proof-of-concept study strongly supports a randomized clinical trial of adjunctive-to-insulin empagliflozin in patients with T1D .

###24730564
BACKGROUND	Heavy drinking is common among students at UK universities .
BACKGROUND	US students overestimate how much their peers drink and correcting this through the use of social norm messages may promote responsible drinking .
OBJECTIVE	We tested whether there is an association between perceived campus drinking norms and usual drinking behavior in UK university students and whether norm messages about responsible drinking correct normative misperceptions and increase students ' intentions to drink responsibly .
METHODS	1,020 UK university students took part in an online study .
METHODS	Participants were exposed to one of five message types : a descriptive norm , an injunctive norm , a descriptive and injunctive norm , or one of two control messages .
METHODS	Message credibility was assessed .
METHODS	Afterwards participants completed measures of intentions to drink responsibly and we measured usual drinking habits and perceptions of peer drinking .
RESULTS	Perceptions of peer drinking were associated modestly with usual drinking behavior , whereby participants who believed other students drank responsibly also drank responsibly .
RESULTS	Norm messages changed normative perceptions , but not in the target population of participants who underestimated responsible drinking in their peers at baseline .
RESULTS	Norm messages did not increase intentions to drink responsibly and although based on accurate data , norm messages were not seen as credible .
CONCLUSIONS	In this UK based study , although perceived social norms about peer drinking were associated with individual differences in drinking habits , campus wide norm messages about responsible drinking did not affect students ' intentions to drink more responsibly .
CONCLUSIONS	More research is required to determine if this approach can be applied to UK settings .

###24608198
BACKGROUND	Oxaliplatin is an integral component of colorectal cancer treatment , but its use is limited by neurotoxicity .
BACKGROUND	The Combined Oxaliplatin Neurotoxicity Prevention Trial ( CONcePT ) tested intermittent oxaliplatin ( IO ) administration and the use of concurrent calcium and magnesium salts ( Ca/Mg ) , two modifications intended to reduce neurotoxicity and extend the duration of treatment .
METHODS	In this trial involving double randomization , 140 patients were randomized to receive modified FOLFOX7 plus bevacizumab with IO ( eight-cycle blocks of oxaliplatin treatment ) versus continuous oxaliplatin ( CO ) ; and Ca/Mg versus placebo ( pre - and postoxaliplatin infusion ) .
METHODS	The primary end point was time-to-treatment failure ( TTF ) .
RESULTS	One hundred thirty-nine patients were entered and treated up to the point of early study termination due to concerns by the data-monitoring committee ( DMC ) that Ca/Mg adversely affected tumor response .
RESULTS	Tumor response was not a study end point .
RESULTS	Given DMC concerns , an additional independent , blinded radiology review of all images showed no adverse effect of treatment schedule or Ca/Mg on response by Response Evaluation Criteria In Solid Tumors .
RESULTS	The IO schedule was superior to CO [ hazard ratio ( HR ) = 0.581 , P = 0.0026 ] for both TTF and time-to-tumor progression ( TTP ) ( HR = 0.533 , P = 0.047 ) .
CONCLUSIONS	An IO dosing schedule had a significant benefit on both TTF and TTP versus CO dosing in this trial despite the very attenuated sample .
CONCLUSIONS	There was no effect of Ca/Mg on response .

###25601789
BACKGROUND	New-generation drug-eluting coronary stents have reduced the risk of coronary events , especially in patients with complex disease or lesions .
BACKGROUND	To what extent different stent platforms , polymers , and antiproliferative drugs affect outcomes , however , is unclear .
BACKGROUND	We investigated the safety and efficacy of a third-generation stent by comparing a highly biocompatible durable-polymer-coated zotarolimus-eluting stent with a biodegradable-polymer-coated biolimus-eluting stent .
METHODS	This open-label , randomised , multicentre , non-inferiority trial was done at three sites across western Denmark .
METHODS	All patients who presented with stable coronary artery disease or acute coronary syndromes and at least one coronary artery lesion ( more than 50 % stenosis ) from March , 2011 , to August , 2012 , were assessed for eligibility .
METHODS	Patients were randomly assigned in a 1:1 ratio to receive either the durable-polymer zotarolimus-eluting stent or the biodegradable-polymer biolimus-eluting stent .
METHODS	The primary endpoint was a composite of safety ( cardiac death and myocardial infarction not clearly attributable to a non-target lesion ) and efficacy ( target-lesion revascularisation ) at 12 months , analysed by intention to treat .
METHODS	The trial was powered to assess non-inferiority of durable-polymer zotarolimus-eluting stent compared with the biodegradable-polymer biolimus-eluting stent with a predetermined non-inferiority margin of 0025 .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01956448 .
RESULTS	Of 7103 screened , 1502 patients with 1883 lesions were assigned to receive the durable-polymer zotarolimus-eluting stent and 1497 patients with 1791 lesions to receive the biodegradable-polymer biolimus-eluting stent .
RESULTS	79 ( 53 % ) and 75 ( 50 % ) patients , respectively , met the primary endpoint ( absolute risk difference 00025 , upper limit of one-sided 95 % CI 0016 % ; p = 0004 ) .
RESULTS	The individual components of the primary endpoint did not differ significantly between stent types at 12 months .
CONCLUSIONS	The durable-polymer-coated zotarolimus-eluting stent was non-inferior to the biodegradable-polymer-coated biolimus-eluting stent in unselected patients .
BACKGROUND	Medtronic Cardiovascular and Biosensors Interventional Technologies .

###25876338
OBJECTIVE	To explore the efficacy and effect mechanism of the combined therapy of acupuncture and tapping method in the treatment of obesity and hyperlipidemia of liver qi stagnation and spleen deficiency pattern in the patients .
METHODS	One hundred and four female patients were randomized into a combined therapy of acupuncture and tapping ( combined therapy group ) group method and an acupuncture group , 52 cases in each group .
METHODS	In the acupuncture group , acupuncture was applied to Qimen ( LR 14 ) , Taichong ( LR 3 ) , Zhangmen ( LR 13 ) , Taibai ( SP 3 ) , Zusanli ( ST 36 ) , Geshu ( BL 17 ) , Ganshu ( BL 18 ) , Pishu ( BL 20 ) , etc. .
METHODS	In the combined therapy group , on the basis of acupuncture treatment , the tapping method with plum blossom needle was used at each acupoint .
METHODS	The treatment was given once every two days , continuously for 3 months in the two groups .
METHODS	The indices were observed , including the obesity indices , such as body mass , body mass index ( BMI ) , body fat percentage ( F % ) and obesity degree ( A ) ; the blood lipid levels such as total cholesterol ( TC ) , triglyceride ( TG ) , low density lipoprotein ( LDL ) and high density lipoprotein ( HDL ) ; the fat-islet axie relevant indices such as fasting plasma glucose ( FBS ) , fasting leptin ( FLP ) , fasting insulin ( FINS ) , insulin sensitive index ( ISI ) , insulin resistance in - dex ( Homa IR ) , insulin secretion index ( Homa - ) and autonomic nerve function index ( Y value ) before and after treatment in the patients of two groups .
METHODS	The efficacy was compared between the two groups .
RESULTS	The total effective rates were 96.2 % ( 50/52 ) and 84.6 % ( 44/52 ) in the combined therapy group and the acupuncture group respectively , without significant difference in comparison ( P > 0.05 ) .
RESULTS	Obesity indices , blood lipid indices , fat-islet axie relevant indices and autonomic nerve function indices were all improved after treatment as compared with those before treatment in the two groups ( P < 0.01 , P < 0.05 ) , and the improvements in the combined therapy group were much more significant ( P < 0.01 , P < 0.05 ) .
CONCLUSIONS	The combined therapy of acupuncture and tapping method achieves the double effects of weight loss and lipid loss in the treatment of obesity combined with hyperlipidemia .
CONCLUSIONS	The effect mechanism is possibly related to the positive regulations of blood glucose , lipid metabolism and fat-islet axie in the patients .

###25335172
BACKGROUND	Cervical radicular pain is a major cause of disability .
BACKGROUND	No studies have been published comparing different types of nonsurgical therapy .
METHODS	A comparative-effectiveness study was performed in 169 patients with cervical radicular pain less than 4 yr in duration .
METHODS	Participants received nortriptyline and/or gabapentin plus physical therapies , up to three cervical epidural steroid injections ( ESI ) or combination treatment over 6 months .
METHODS	The primary outcome measure was average arm pain on a 0 to 10 scale at 1 month .
RESULTS	One-month arm pain scores were 3.5 ( 95 % CI , 2.8 to 4.2 ) in the combination group , 4.2 ( CI , 2.8 to 4.2 ) in ESI patients , and 4.3 ( CI , 2.8 to 4.2 ) in individuals treated conservatively ( P = 0.26 ) .
RESULTS	Combination group patients experienced a mean reduction of -3.1 ( 95 % CI , -3.8 to -2.3 ) in average arm pain at 1 month versus -1.8 ( CI , -2.5 to -1.2 ) in the conservative group and -2.0 ( CI , -2.7 to -1.3 ) in ESI patients ( P = 0.035 ) .
RESULTS	For neck pain , a mean reduction of -2.2 ( 95 % CI , -3.0 to -1.5 ) was noted in combination patients versus -1.2 ( CI , -1.9 to -0.5 ) in conservative group patients and -1.1 ( CI , -1.8 to -0.4 ) in those who received ESI ; P = 0.064 ) .
RESULTS	Three-month posttreatment , 56.9 % of patients treated with combination therapy experienced a positive outcome versus 26.8 % in the conservative group and 36.7 % in ESI patients ( P = 0.006 ) .
CONCLUSIONS	For the primary outcome measure , no significant differences were found between treatments , although combination therapy provided better improvement than stand-alone treatment on some measures .
CONCLUSIONS	Whereas these results suggest an interdisciplinary approach to neck pain may improve outcomes , confirmatory studies are needed .

###24927851
BACKGROUND	This study examines the cost effectiveness of group follow-up after participation in the Dose Adjustment for Normal Eating ( DAFNE ) structured education programme for type 1 diabetes .
METHODS	Economic evaluation conducted alongside a cluster randomised controlled trial involving 437 adults with type 1 diabetes in Ireland .
METHODS	Group follow-up involved two group education ` booster ' sessions post-DAFNE .
METHODS	Individual follow-up involved two standard one-to-one hospital clinic visits .
METHODS	Incremental costs , quality-adjusted life years ( QALYs ) gained and cost effectiveness were estimated at 18 months .
METHODS	Uncertainty was explored using sensitivity analysis and by estimating cost effectiveness acceptability curves .
RESULTS	Group follow-up was associated with a mean reduction in QALYs gained of 0.04 per patient ( P value , 0.052 ; 95 % CI , -0.08 to 0.01 , intra-class correlation ( ICC ) , 0.033 ) and a mean reduction in total healthcare costs of 772 ( P value , 0.020 ; 95 % CI , -1,415 to -128 : ICC , 0.016 ) per patient .
RESULTS	At alternative threshold values of 5,000 , 15,000 , 25,000 , 35,000 , and 45,000 , the probability of group follow-up being cost effective was estimated to be 1.000 , 0.762 , 0.204 , 0.078 , and 0.033 respectively .
CONCLUSIONS	The results do not support implementation of group follow-up as the sole means of follow-up post-DAFNE .
CONCLUSIONS	Given the reported cost savings , future studies should explore the cost effectiveness of alternative models of group care for diabetes .
BACKGROUND	Current Controlled Trials ISRCTN79759174 ( assigned : 9 February 2007 ) .

###24725355
BACKGROUND	To evaluate and compare the effectiveness of the combined regimen ( consisting of condoms and emergency contraception pills ( ECP ) ) and using condoms only for the purpose of preventing pregnancy .
METHODS	One-thousand-five-hundred-and-sixty-two ( 1,562 ) couples as volunteers enrolled at nine centers in Shanghai .
METHODS	Eight-hundred-and-twelve ( 812 ) were randomized to use male condoms and ECP ( i.e. , Levonorgestrel ) as a back-up to condoms ( the intervention group ) and 750 to use male condoms only ( the control group ) , according to their working unit .
METHODS	Participants were visited at admission and at the end of 1 , 3 , 6 , 9 , and 12 months .
METHODS	The cumulative life table rates were calculated for pregnancy and other reasons for discontinuation .
RESULTS	The gross cumulative life table rates showed that the cumulative discontinuation rates for all reasons during the year of follow-up in the condoms plus emergency contraception group and the condoms only group were 7.760.94 and 6.610.91 , respectively , per 100 women ( 2 = 0.41 , p = 0.5227 ) .
RESULTS	The cumulative gross pregnancy rate of the condoms plus emergency contraception group and the condoms only group were 2.170.52 and 1.250.41 , respectively , per 100 women ( 2 = 1.93 , p = 0.1645 ) .
RESULTS	The Pearl Index in the condoms plus emergency contraception group and the condoms only group were 2.21 % and 1.26 % , respectively .
CONCLUSIONS	Male condoms remain a highly effective contraceptive method for a period of one year while consistently and correctly used .
CONCLUSIONS	In addition , the lowest pregnancy rate followed from perfect use condom .

###24334780
BACKGROUND	Comorbid substance related disorders are a major health problem for patients in opioid maintenance treatment ( OMT ) .
BACKGROUND	It was investigated whether a reinforcement scheme adapted to the regulatory and financial restrictions of routine treatment reduces concomitant drug use .
METHODS	OMT patients from 7 clinics who were using cocaine , benzodiazepines , heroin or amphetamines were randomly allocated to either treatment as usual ( n = 64 ) or treatment with an additional escalating reinforcement scheme ( n = 72 ) in which a patient 's number of weekly take-home dosages was increased after 1 , 4 , 8 and 12 consecutive weeks with drug-free urine specimens .
METHODS	Trial duration was 26 weeks .
RESULTS	Completion rates were 64 % for controls and 62.5 % in the experimental group .
RESULTS	Mean number of drug-free weeks was 11.3 ( SD 8.5 ) for the control group and 9.8 ( 8.9 ) for the experimental group ( p = 0.30 ) .
CONCLUSIONS	The intervention was not effective compared to routine treatment .
CONCLUSIONS	Additional features might be necessary to achieve an effect , e.g. a higher frequency of urine sampling or use of other reinforcers .
CONCLUSIONS	It has to be further investigated how interventions which have been proven effective in experimental studies can successfully be adapted to routine care conditions .

###25099318
BACKGROUND	Corticoids have potent anti-inflammatory effects , which may help in relieving pain and dysfunction associated with lumbar canal stenosis .
BACKGROUND	We assessed the effectiveness of a decreasing-dose regimen of oral corticoids in the treatment of lumbar canal stenosis in a prospective , double-blind , randomized , placebo-controlled trial .
RESULTS	Sixty-one patients with lumbar canal stenosis ( 50-75 years ; canal area < 100mm2 at L3/L4 , L4/L5 , and/or L5/S1on magnetic resonance imaging ; and claudication within 100m were electronically randomized to an oral corticoid group ( n = 31 ) or a placebo group ( n = 30 ) .
RESULTS	The treatment group received 1mg/kg of oral corticoids daily , with a dose reduction of one-third per week for 3weeks .
RESULTS	Patients and controls were assessed by the Short Form 36 Health Survey , Roland-Morris Questionnaire , 6-min walk test , visual analog scale , and a Likert scale .
RESULTS	All instruments showed similar outcomes for the corticoid and placebo groups ( P > 0.05 ) .
RESULTS	Obese patients exhibited more severe symptoms compared with non-obese patients .
RESULTS	L4/L5 stenosis was associated with more severe symptoms compared with stenosis at other levels .
CONCLUSIONS	The oral corticoid regimen used in this study was not effective in the treatment of lumbar canal stenosis .

###25472864
BACKGROUND	Use of hypotonic intravenous fluid to maintain hydration in children in hospital has been associated with hyponatraemia , leading to neurological morbidity and mortality .
BACKGROUND	We aimed to assess whether use of fluid solutions with a higher sodium concentration reduced the risk of hyponatraemia compared with use of hypotonic solutions .
METHODS	We did a randomised controlled double-blind trial of children admitted to The Royal Children 's Hospital ( Melbourne , VIC , Australia ) who needed intravenous maintenance hydration for 6 h or longer .
METHODS	With an online randomisation system that used unequal block sizes , we randomly assigned patients ( 1:1 ) to receive either isotonic intravenous fluid containing 140 mmol/L of sodium ( Na140 ) or hypotonic fluid containing 77 mmol/L of sodium ( Na77 ) for 72 h or until their intravenous fluid rate decreased to lower than 50 % of the standard maintenance rate .
METHODS	We stratified assignment by baseline sodium concentrations .
METHODS	Study investigators , treating clinicians , nurses , and patients were masked to treatment assignment .
METHODS	The primary outcome was occurrence of hyponatraemia ( serum sodium concentration < 135 mmol/L with a decrease of at least 3 mmol/L from baseline ) during the treatment period , analysed by intention to treat .
METHODS	The trial was registered with the Australian New Zealand Clinical Trials Registry , number ACTRN1260900924257 .
RESULTS	Between Feb 2 , 2010 , and Jan 29 , 2013 , we randomly assigned 690 patients .
RESULTS	Of these patients , primary outcome data were available for 319 who received Na140 and 322 who received Na77 .
RESULTS	Fewer patients given Na140 than those given Na77 developed hyponatraemia ( 12 patients [ 4 % ] vs 35 [ 11 % ] ; odds ratio [ OR ] 031 , 95 % CI 016-061 ; p = 0001 ) .
RESULTS	No clinically apparent cerebral oedema occurred in either group .
RESULTS	Eight patients in the Na140 group ( two potentially related to intravenous fluid ) and four in the Na77 group ( none related to intravenous fluid ) developed serious adverse events during the treatment period .
RESULTS	One patient in the Na140 had seizures during the treatment period compared with seven who received Na77 .
CONCLUSIONS	Use of isotonic intravenous fluid with a sodium concentration of 140 mmol/L had a lower risk of hyponatraemia without an increase in adverse effects than did fluid containing 77 mmol/L of sodium .
CONCLUSIONS	An isotonic fluid should be used as intravenous fluid for maintenance hydration in children .
BACKGROUND	National Health and Medical Research Council , Murdoch Childrens Research Institute , The Royal Children 's Hospital , and the Australian and New Zealand College of Anaesthetists .

###26422723
BACKGROUND	In a phase 2 study , the inhibition of the interleukin-17A receptor improved signs and symptoms of psoriatic arthritis .
BACKGROUND	We sought to evaluate the efficacy and safety of secukinumab , an anti-interleukin-17A monoclonal antibody , in such patients .
METHODS	In this double-blind , phase 3 study , 606 patients with psoriatic arthritis were randomly assigned in a 1:1:1 ratio to receive intravenous secukinumab ( at a dose of 10 mg per kilogram ) at weeks 0 , 2 , and 4 , followed by subcutaneous secukinumab at a dose of either 150 mg or 75 mg every 4 weeks , or placebo .
METHODS	Patients in the placebo group were switched to subcutaneous secukinumab at a dose of 150 mg or 75 mg at week 16 or 24 , depending on clinical response .
METHODS	The primary end point was the proportion of patients with an American College of Rheumatology 20 ( ACR20 ) response at week 24 , defined as a 20 % improvement from baseline in the number of tender and swollen joints and at least three other important domains .
RESULTS	ACR20 response rates at week 24 were significantly higher in the group receiving secukinumab at doses of 150 mg ( 50.0 % ) and 75 mg ( 50.5 % ) than in those receiving placebo ( 17.3 % ) ( P < 0.001 for both comparisons with placebo ) .
RESULTS	Secondary end points , including the ACR50 response and joint structural damage , were significantly better in the secukinumab groups than in the placebo group .
RESULTS	Improvements were sustained through 52 weeks .
RESULTS	Infections , including candida , were more common in the secukinumab groups .
RESULTS	Throughout the study ( mean secukinumab exposure , 438.5 days ; mean placebo exposure , 128.5 days ) , four patients in the secukinumab groups had a stroke ( 0.6 per 100 patient-years ; 95 % confidence interval [ CI ] , 0.2 to 1.5 ) , and two had a myocardial infarction ( 0.3 per 100 patient-years ; 95 % CI , 0.0 to 1.0 ) , as compared with no patients in the placebo group .
CONCLUSIONS	Secukinumab was more effective than placebo in patients with psoriatic arthritis , which validates interleukin-17A as a therapeutic target .
CONCLUSIONS	Infections were more common in the secukinumab groups than in the placebo group .
CONCLUSIONS	The study was neither large enough nor long enough to evaluate uncommon serious adverse events or the risks associated with long-term use .
CONCLUSIONS	( Funded by Novartis Pharma ; ClinicalTrials.gov number , NCT01392326 . )

###25492411
OBJECTIVE	Does substituting 150 g corifollitropin alfa for 450 IU follitropin beta during the first 7 days of ovarian stimulation in proven poor responders , result in retrieval of a non-inferior number ( < 1.5 fewer ) of cumulus oocyte complexes ( COCs ) ?
CONCLUSIONS	A single s.c. dose of 150 g corifollitropin alfa on the first day of ovarian stimulation , followed if necessary , from Day 8 onwards , with 450 IU of follitropin beta/day , is not inferior to daily doses of 450 IU follitropin beta .
CONCLUSIONS	The 95 % CI of the difference between medians in the number of oocytes retrieved was -1 to +1 within the safety margin of 1.5 .
BACKGROUND	Recent data from retrospective studies suggest that the use of corifollitropin alfa in poor responders is promising since it could simplify ovarian stimulation without compromising its outcome .
METHODS	Seventy-nine women with previous poor ovarian response undergoing ICSI treatment were enrolled in this open label , non-inferiority , randomized clinical trial ( RCT ) .
METHODS	Inclusion criteria were : previous poor response to ovarian stimulation ( 4 COCs ) after maximal stimulation , age < 45 years , regular spontaneous menstrual cycle , body mass index : 18-32 kg/m ( 2 ) and basal follicle stimulating hormone 20 IU/l .
METHODS	On Day 2 of the menstrual cycle , patients were administered either a single s.c dose of 150 g corifollitropin alfa ( n = 40 ) or a fixed daily dose of 450 IU of follitropin beta ( n = 39 ) .
METHODS	In the corifollitropin alfa group , 450 IU of follitropin beta were administered from Day 8 of stimulation until the day of human chorionic gonadotrophin ( hCG ) administration , if necessary .
METHODS	To inhibit premature luteinizing hormone surge , the gonadotrophin releasing hormone antagonist ganirelix was used .
METHODS	Triggering of final oocyte maturation was performed using 250 g of recombinant hCG , when at least two follicles reached 17 mm in mean diameter .
RESULTS	The number of COCs retrieved was not statistically different between the corifollitropin alfa and the follitropin beta groups [ Median 3 versus 2 , 95 % CI 2-4 , 2-3 , respectively , P = 0.26 ] .
RESULTS	The 95 % CI of the difference between medians in the number of oocytes retrieved was -1 to +1 .
RESULTS	A multivariable analysis adjusting for all the potential baseline differences confirmed this finding .
RESULTS	No significant difference was observed regarding the probability of live birth between the corifollitropin alfa and the follitropin beta group ( live birth per patient reaching oocyte retrieval : 7.9 versus 2.6 % , respectively , difference +5.3 % , 95 % CI : -6.8 to +18.3 ) .
CONCLUSIONS	The present study was not powered to test a smaller difference ( e.g. 1 COC ) in terms of COCs retrieved as well as to show potential differences in the probability of pregnancy .
CONCLUSIONS	Moreover , it would be interesting to assess whether the continuation of stimulation in the long acting FSH arm , where necessary , with 200 IU instead of 450 IU of follitropin beta would have altered the direction or the magnitude of the effect of the type of FSH , observed on the number of COCs retrieved .
CONCLUSIONS	Corifollitropin alfa simplifies IVF treatment because it is administered in a GnRH antagonist protocol and replaces seven daily FSH injections with a single one of a long acting FSH without compromising the outcome .
CONCLUSIONS	It could greatly reduce the burden of treatment for poor responders and this deserves further investigation .

###24308672
BACKGROUND	Recently , a number of studies using intra-articular application of tranexamic acid ( IA-TXA ) , with different dosage and techniques , successfully reduced postoperative blood loss in total knee replacement ( TKR ) .
BACKGROUND	However , best of our knowledge , the very low dose of IA-TXA with drain clamping technique in conventional TKR has not been yet studied .
BACKGROUND	This study aimed to evaluate the effectiveness and dose-response effect of two low-dose IA-TXA regimens in conventional TKR on blood loss and blood transfusion reduction .
METHODS	Between 2010 and 2011 , a triple-blinded randomized controlled study was conducted in 135 patients undergoing conventional TKR .
METHODS	The patients were allocated into three groups according to intra-articular solution received : Control group ( physiologic saline ) , TXA-250 group ( TXA 250 mg ) , and TXA-500 group ( TXA 500 mg ) .
METHODS	The solution was injected after wound closure followed by drain clamping for 2 hours .
METHODS	Blood loss and transfusion were recorded .
METHODS	Duplex ultrasound was performed .
METHODS	Functional outcome and complication were followed for one year .
RESULTS	There were forty-five patients per groups .
RESULTS	The mean total hemoglobin loss was 2.9 g/dL in control group compared with 2.2 g/dL in both TXA groups ( p > 0.001 ) .
RESULTS	Ten patients ( 22 % , control ) , six patients ( 13 % , TXA-250 ) and none ( TXA-500 ) required transfusion ( p = 0.005 ) .
RESULTS	Thromboembolic events were detected in 7 patients ( 4 controls , 1 TXA-250 , and 2 TXA-500 ) .
RESULTS	Functional outcome was non-significant difference between groups .
CONCLUSIONS	Combined low-dose IA-TXA , as 500 mg , with 2-hour clamp drain is effective for reducing postoperative blood loss and transfusion in conventional TKR without significant difference in postoperative knee function or complication .
BACKGROUND	ClinicalTrials.gov NCT01850394 .

###24635772
BACKGROUND	Although previous studies have suggested the potential advantages of albumin administration in patients with severe sepsis , its efficacy has not been fully established .
METHODS	In this multicenter , open-label trial , we randomly assigned 1818 patients with severe sepsis , in 100 intensive care units ( ICUs ) , to receive either 20 % albumin and crystalloid solution or crystalloid solution alone .
METHODS	In the albumin group , the target serum albumin concentration was 30 g per liter or more until discharge from the ICU or 28 days after randomization .
METHODS	The primary outcome was death from any cause at 28 days .
METHODS	Secondary outcomes were death from any cause at 90 days , the number of patients with organ dysfunction and the degree of dysfunction , and length of stay in the ICU and the hospital .
RESULTS	During the first 7 days , patients in the albumin group , as compared with those in the crystalloid group , had a higher mean arterial pressure ( P = 0.03 ) and lower net fluid balance ( P < 0.001 ) .
RESULTS	The total daily amount of administered fluid did not differ significantly between the two groups ( P = 0.10 ) .
RESULTS	At 28 days , 285 of 895 patients ( 31.8 % ) in the albumin group and 288 of 900 ( 32.0 % ) in the crystalloid group had died ( relative risk in the albumin group , 1.00 ; 95 % confidence interval [ CI ] , 0.87 to 1.14 ; P = 0.94 ) .
RESULTS	At 90 days , 365 of 888 patients ( 41.1 % ) in the albumin group and 389 of 893 ( 43.6 % ) in the crystalloid group had died ( relative risk , 0.94 ; 95 % CI , 0.85 to 1.05 ; P = 0.29 ) .
RESULTS	No significant differences in other secondary outcomes were observed between the two groups .
CONCLUSIONS	In patients with severe sepsis , albumin replacement in addition to crystalloids , as compared with crystalloids alone , did not improve the rate of survival at 28 and 90 days .
CONCLUSIONS	( Funded by the Italian Medicines Agency ; ALBIOS ClinicalTrials.gov number , NCT00707122 . )

###24974854
OBJECTIVE	To assess the most effective local analgesia during transrectal ultrasound-guided prostate biopsy .
METHODS	A total of 123 consecutive patients undergoing transrectal ultrasound-guided prostate biopsy for elevated prostate-specific antigen levels and/or a suspicious digital rectal examination were randomized to three groups .
METHODS	Patients received a 60-mg lidocaine suppository ( group 1 , n = 41 ) , a periprostatic nerve block ( 10-mL injection of lidocaine hydrochloride ; group 2 , n = 41 ) or a combination of both ( group 3 , n = 41 ) before a 10-core transrectal ultrasound-guided biopsy .
METHODS	A total of 80.5 % ( n = 99 ) of the patients underwent their first biopsy , 27.1 % ( n = 22 ) their second and 2.4 % ( n = 2 ) the third .
METHODS	Pain was evaluated on a 10-point visual analog scale for each step of the procedure .
RESULTS	Prostate-specific antigen values ranged from 0.39 to 90.1 ( mean [ SD ] 8.76 ng/mL [ 11.08 ng/mL ] ) .
RESULTS	Comparison of the median visual analog scale scores between groups 1 and 2 showed a significant difference ( P = 0.004 ) .
RESULTS	The differences in the outcomes between groups 1 and 3 ( P = 0.001 ) , and groups 2 and 3 ( P = 0.001 ) were also significant .
RESULTS	Patients of group 3 had the best output corresponding to the pain sensations and therefore the lowest visual analog scale scores .
CONCLUSIONS	The combination of lidocaine suppository and periprostatic lidocaine infiltration is more effective for pain control than either lidocaine suppository or periprostatic lidocaine infiltration alone in patients undergoing transrectal ultrasound-guided prostate biopsy .

###24331121
OBJECTIVE	We hypothesized that arthroscopic rotator cuff repairs using leukocyte - and platelet-rich fibrin ( L-PRF ) in a standardized , modified protocol is technically feasible and results in a higher vascularization response and watertight healing rate during early healing .
METHODS	Twenty patients with chronic rotator cuff tears were randomly assigned to 2 treatment groups .
METHODS	In the test group ( N = 10 ) , L-PRF was added in between the tendon and the bone during arthroscopic rotator cuff repair .
METHODS	The second group served as control ( N = 10 ) .
METHODS	They received the same arthroscopic treatment without the use of L-PRF .
METHODS	We used a double-row tension band technique .
METHODS	Clinical examinations including subjective shoulder value , visual analog scale , Constant , and Simple Shoulder Test scores and measurement of the vascularization with power Doppler ultrasonography were made at 6 and 12 weeks .
RESULTS	There have been no postoperative complications .
RESULTS	At 6 and 12 weeks , there was no significant difference in the clinical scores between the test and the control groups .
RESULTS	The mean vascularization index of the surgical tendon-to-bone insertions was always significantly higher in the L-PRF group than in the contralateral healthy shoulders at 6 and 12 weeks ( P = .0001 ) .
RESULTS	Whereas the L-PRF group showed a higher vascularization compared with the control group at 6 weeks ( P = .001 ) , there was no difference after 12 weeks of follow-up ( P = .889 ) .
RESULTS	Watertight healing was obtained in 89 % of the repaired cuffs .
CONCLUSIONS	Arthroscopic rotator cuff repair with the application of L-PRF is technically feasible and yields higher early vascularization .
CONCLUSIONS	Increased vascularization may potentially predispose to an increased and earlier cellular response and an increased healing rate .

###24739328
BACKGROUND	The measurement of mechanosensitivity is a key method for the study of pain in animal models .
BACKGROUND	This is often accomplished with the use of von Frey filaments in an up-down testing paradigm .
BACKGROUND	The up-down method described by Chaplan et al. ( J Neurosci Methods 53:55 -63 , 1994 ) for mechanosensitivity testing in rodents remains one of the most widely used methods for measuring pain in animals .
BACKGROUND	However , this method results in animals receiving a varying number of stimuli , which may lead to animals in different groups receiving different testing experiences that influences their later responses .
BACKGROUND	To standardize the measurement of mechanosensitivity we developed a simplified up-down method ( SUDO ) for estimating paw withdrawal threshold ( PWT ) with von Frey filaments that uses a constant number of five stimuli per test .
BACKGROUND	We further refined the PWT calculation to allow the estimation of PWT directly from the behavioral response to the fifth stimulus , omitting the need for look-up tables .
RESULTS	The PWT estimates derived using SUDO strongly correlated ( r > 0.96 ) with the PWT estimates determined with the conventional up-down method of Chaplan et al. , and this correlation remained very strong across different levels of tester experience , different experimental conditions , and in tests from both mice and rats .
RESULTS	The two testing methods also produced similar PWT estimates in prospective behavioral tests of mice at baseline and after induction of hyperalgesia by intraplantar capsaicin or complete Freund 's adjuvant .
CONCLUSIONS	SUDO thus offers an accurate , fast and user-friendly replacement for the widely used up-down method of Chaplan et al. .

###26093871
BACKGROUND	It is unclear if holding angiotensin-converting enzyme inhibitors ( ACEI ) or angiotensin receptor blockers ( ARB ) prior to coronary angiography reduces contrast-induced acute kidney injury ( AKI ) .
BACKGROUND	We undertook a randomized trial to investigate the effect of holding ACEI/ARB therapy prior to coronary angiography on the incidence of AKI .
METHODS	We randomly assigned 208 patients with moderate renal insufficiency ( creatinine 1.7 mg/dL within 3 months and/or documented creatinine 1.5 mg/dL within 1 week before cardiac catheterization ) to hold ACEI/ARB 24 hours preprocedure or continue ACEI/ARB .
METHODS	The primary outcome was the incidence of AKI defined as an absolute rise in serum creatinine of 0.5 mg/dL from baseline and/or a relative rise in serum creatinine of 25 % compared with baseline measured at 48 to 96 hours postcardiac catheterization .
RESULTS	All patients were taking an ACEI ( 72.1 % ) or ARB ( 27.9 % ) prior to randomization .
RESULTS	At 48 to 96 hours , the primary outcome occurred in 18.4 % of patients who continued ACEI/ARB compared with 10.9 % of the patients who held ACEI/ARB ( hazard ratio 0.59 , 95 % CI 0.30-1 .19 , P = .16 ) .
RESULTS	In a prespecified secondary outcome , there was a lower rise in mean serum creatinine after the procedure in patients who held ACEI/ARB ( 0.3 0.5 vs 0.1 0.3 mg/dL , P = .03 ) .
RESULTS	The clinical composite of death , myocardial infarction , ischemic stroke , congestive heart failure , rehospitalization for cardiovascular cause , or need for dialysis preprocedure occurred in 3.9 % who continued ACEI/ARB compared with 0 % who held the ACEI/ARB ( hazard ratio 0.11 , 95 % CI 0.01-2 .96 , P = .06 ) .
CONCLUSIONS	In this pilot study of patients with moderate renal insufficiency undergoing cardiac catheterization , with-holding ACEI/ARB resulted in a non-significant reduction in contrast-induced AKI and a significant reduction in post-procedural rise of creatinine .
CONCLUSIONS	This low cost intervention could be considered when referring a patient for cardiac catheterization .

###25304723
BACKGROUND	Few studies have evaluated the possible beneficial effect of the administration of stem cells in the early stages of stroke .
BACKGROUND	Intravenous administration of allogeneic mesenchymal stem cells ( MSCs ) from adipose tissue in patients with acute stroke could be a safe therapy for promoting neurovascular unit repair , consequently supporting better functional recovery .
BACKGROUND	We aim to assess the safety and efficacy of MSC administration and evaluate its potential as a treatment for cerebral protection and repair .
METHODS	A Phase IIa , prospective , randomized , double-blind , placebo-controlled , single-center , pilot clinical trial .
METHODS	Twenty patients presenting acute ischemic stroke will be randomized in a 1:1 proportion to treatment with allogeneic MSCs from adipose tissue or to placebo ( or vehicle ) administered as a single intravenous dose within the first 2 weeks after the onset of stroke symptoms .
METHODS	The patients will be followed up for 2 years .
METHODS	Primary outcomes for safety analysis : adverse events ( AEs ) and serious AEs ; neurologic and systemic complications , and tumor development .
METHODS	Secondary outcomes for efficacy analysis : modified Rankin Scale ; NIHSS ; infarct size ; and biochemical markers of brain repair ( vascular endothelial growth factor , brain-derived neurotrophic factor , and matrix metalloproteinases 9 ) .
CONCLUSIONS	To our knowledge , this is the first , phase II , pilot clinical trial to investigate the safety and efficacy of intravenous administration of allogeneic MSCs from adipose tissue within the first 2 weeks of stroke .
CONCLUSIONS	In addition , its results will help us define the best criteria for a future phase III study .

###24297950
OBJECTIVE	This international phase III trial ( Investigating Torisel As Second-Line Therapy [ INTORSECT ] ) compared the efficacy of temsirolimus ( mammalian target of rapamycin inhibitor ) and sorafenib ( vascular endothelial growth factor receptor [ VEGFR ] tyrosine kinase inhibitor ) as second-line therapy in patients with metastatic renal cell carcinoma ( mRCC ) after disease progression on sunitinib .
METHODS	In total , 512 patients were randomly assigned 1:1 to receive intravenous temsirolimus 25 mg once weekly ( n = 259 ) or oral sorafenib 400 mg twice per day ( n = 253 ) , with stratification according to duration of prior sunitinib therapy ( or > 180 days ) , prognostic risk , histology ( clear cell or non-clear cell ) , and nephrectomy status .
METHODS	The primary end point was progression-free survival ( PFS ) by independent review committee assessment .
METHODS	Safety , objective response rate ( ORR ) , and overall survival ( OS ) were secondary end points .
RESULTS	Primary analysis revealed no significant difference between treatment arms for PFS ( stratified hazard ratio [ HR ] , 0.87 ; 95 % CI , 0.71 to 1.07 ; two-sided P = .19 ) or ORR .
RESULTS	Median PFS in the temsirolimus and sorafenib arms were 4.3 and 3.9 months , respectively .
RESULTS	There was a significant OS difference in favor of sorafenib ( stratified HR , 1.31 ; 95 % CI , 1.05 to 1.63 ; two-sided P = .01 ) .
RESULTS	Median OS in the temsirolimus and sorafenib arms was 12.3 and 16.6 months , respectively .
RESULTS	Safety profiles of both agents were consistent with previous studies .
CONCLUSIONS	In patients with mRCC and progression on sunitinib , second-line temsirolimus did not demonstrate a PFS advantage compared with sorafenib .
CONCLUSIONS	The longer OS observed with sorafenib suggests sequenced VEGFR inhibition may benefit patients with mRCC .

###24794093
BACKGROUND	Parathyroidectomy in patients with hyperparathyroidism can produce subsequent increases in bone mineral density ( BMD ) .
BACKGROUND	Ronacaleret , a selective calcium-sensing receptor antagonist that stimulates endogenous parathyroid hormone release , induced mild hyperparathyroidism .
OBJECTIVE	The aim of this study is to evaluate whether BMD changes after cessation of ronacaleret treatment .
METHODS	Observational , off-treatment , extension of a randomized , placebo-controlled , dose-ranging phase II trial .
METHODS	Fifteen academic centers in seven countries .
METHODS	Postmenopausal women with low BMD ; 171 out of 569 women in the parent study were enrolled in the extension study .
METHODS	Subjects were treated with ronacaleret 100mg ( n = 16 ) , 200mg ( n = 38 ) , 300mg ( n = 35 ) , or 400mg ( n = 32 ) once daily , alendronate 70mg ( n = 17 ) once weekly , or matching placebo ( n = 33 ) for 10-12months ; BMD was measured after discontinuation of ronacaleret or alendronate treatment .
METHODS	Mean percent change in lumbar spine areal BMD by dual-energy X-ray absorptiometry at 6-12months after discontinuing ronacaleret or alendronate compared with the 10 - to 12-month BMD measurement of the parent study .
RESULTS	At the lumbar spine , all doses of ronacaleret resulted in gains in BMD while on treatment .
RESULTS	These increases in BMD were maintained or increased after discontinuation of ronacaleret .
RESULTS	All doses of ronacaleret caused bone loss at the total hip while on active treatment .
RESULTS	However , there was an attenuation of this loss in the off-treatment extension study .
CONCLUSIONS	The gain in BMD at the lumbar spine was maintained post-treatment and the loss of BMD at the total hip was attenuated .
CONCLUSIONS	We hypothesize that there may have been some bone remineralization after cessation of ronacaleret .

###24662570
OBJECTIVE	To study the influence of aerobic exercise training on brain-derived neurotrophic factor ( BDNF ) , insulin resistance , and lipid profile in middle-aged men diagnosed with metabolic syndrome ( MetS ) .
METHODS	This is an experimental repeated measure study .
METHODS	Subjects participated in aerobic training programs ( 18 sessions of 25-40 minutes per session ) in Guilan University gymnasium and court .
METHODS	A total of 21 middle-aged men ( 50-65 years old ) diagnosed with MetS participated .
METHODS	We randomly divided 21 middle-aged men with MetS into exercise and control groups .
METHODS	The exercise group followed an aerobic training program ( 18 sessions , 3/wk ) at 50 % to 60 % of V [ Combining Dot Above ] O2 peak ( 25-40 minutes per session ) and 6 weeks of detraining .
METHODS	Blood samples were collected at baseline , end of the training , and detraining .
METHODS	High BDNF level in patients with MetS and its reduction after chronic aerobic exercise .
RESULTS	Aerobic training significantly decreased all the metabolic risk factors , including overall MetS z score , insulin resistance , and lipid profile ( P < 0.05 ) .
RESULTS	After the detraining period , plasma triglyceride , high-density lipoprotein , and also overall MetS z score remained unchanged ( P < 0.05 ) ; however , serum BDNF , which was decreased by aerobic training ( P = 0.013 ) , restored to the baseline at the end of the detraining ( P = 0.018 ) .
CONCLUSIONS	Improved metabolic risk factors along with decreased serum BDNF in response to aerobic training and the opposite direction during the detraining emphasize the importance of physical activity in the treatment of MetS and prevention of related diseases .

###24531309
OBJECTIVE	The aims of this study were to compare strut tissue coverage at six-month follow-up after Nobori biolimus-eluting stent ( N-BES ) versus sirolimus-eluting stent ( SES ) implantation .
RESULTS	A total of 120 patients with a single stenotic lesion requiring revascularisation were randomly assigned to either N-BES ( n = 60 ) or SES ( n = 60 ) .
RESULTS	Baseline optical coherence tomography ( OCT ) was performed post stent implantation , and follow-up OCT was scheduled at six months .
RESULTS	Post-intervention and follow-up OCT analyses were available in 51 ( 85.0 % ) and 52 ( 86.7 % ) patients , respectively .
RESULTS	The primary endpoint was the percentage of uncovered struts at follow-up OCT in all cross-sections with analysis of 0.2 mm longitudinal intervals .
RESULTS	In addition , an OCT contour plot analysis was constructed to investigate the distribution patterns of uncovered struts .
RESULTS	The percentage of uncovered struts of N-BES was significantly lower versus SES ( 15.912.2 % versus 25.118.3 % , respectively , p = 0.003 ) .
RESULTS	N-BES showed a greater NIH thickness than SES ( median [ interquartile range ] 52.4 m [ 41.9-74 .9 ] versus 42.1 m [ 30.6-56 .0 ] , p = 0.005 ) .
RESULTS	Contour plot analyses showed a lower incidence of a diffuse distribution pattern of uncovered struts ( 46.8 % versus 75.0 % , respectively , p = 0.022 ) .
CONCLUSIONS	This randomised OCT study showed that N-BES had a significantly lower percentage of uncovered struts , and less common diffuse distribution pattern of uncovered struts versus SES .

###25623098
OBJECTIVE	To explore the necessity of interrupting nerve fibers of bypass thoracic sympathetic chain during edoscopic sympathicotomy ( ETS ) for palmar hyperhidrosis .
METHODS	Randomized controlled trial was performed for 200 patients of severe palmar hyperhidrosis from January 2009 to June 2011 .
METHODS	They were randomly divided into 2 groups of R3 thoracic sympathctomy ( R3 ) and R3 thoracic sympathicotomy plus bypass fiber resection at the same level ( R3 + ) ( n = 100 each ) .
METHODS	Clinical observations were recorded during a follow-up period of 3 years .
RESULTS	The curative rates of palmar and axillary hyperhidrosis were 100 % for two groups .
RESULTS	No statistically significant inter-group difference existed in left hand temperature increase after transecting thoracic sympathetic nerve ( 3.6 1.4 C vs 3.5 1.3 C ) , right hand increase ( 3.8 1.3 C vs 3.9 1.1 C ) , incidence of compensatory hyperhidrosis ( 40 % vs 44 % ) , recurrence rate ( 1 % vs 2 % ) and postoperative satisfaction rate ( 92 % vs 90 % ) .
RESULTS	But pain scores of R3 group was significantly lower than those of R3 + group ( 3.0 1.9 vs 3.6 1.9 , P < 0.05 ) .
CONCLUSIONS	Simple transaction of thoracic sympathetic chain during ETS is sufficient in the treatment of palmar hyperhidrosis .
CONCLUSIONS	And it is unnecessary to transect bypass fibers .

###25169679
OBJECTIVE	Most blood donors stop donating blood at the beginning of their donor career .
OBJECTIVE	This intervention study aims to increase first-time return behaviour of newly registered donors using implementation intentions and explicit commitment techniques .
METHODS	Newly registered donors ( N = 937 ) received an extra information sheet during their medical check-up wherein implementation intentions and explicit commitment techniques were tested .
METHODS	Donors were randomly assigned to either the control condition , information sheet only condition , information sheet with implementation intentions condition , information sheet with explicit commitment condition , or information sheet with both implementation intentions and explicit commitment condition .
METHODS	Logistic regression analyses examined actual first-time return behaviour after an appeal to donate blood .
RESULTS	Donors in the information sheet with both implementation intentions and explicit commitment condition had an 11.5 % higher return rate than donors in the control condition .
RESULTS	Logistic regression analyses revealed that the information sheet with both implementation intentions and explicit commitment condition significantly increased the odds on return behaviour compared with the control condition ( OR = 1.65 , 95 % CI = 1.08-2 .50 ) .
CONCLUSIONS	This study successfully increased actual first-time return behaviour of newly registered donors by using both implementation intentions and explicit commitment techniques .

###24573015
OBJECTIVE	The prognoses of symptomatic and asymptomatic intracranial atherosclerotic stenosis ( ICAS ) differ .
OBJECTIVE	Understanding the underlying pathomechanisms and predictors of progression or regression may help to clarify the differences .
OBJECTIVE	We herein attempted to compare the course and predictors of symptomatic ICAS to those of coexisting asymptomatic ICAS .
METHODS	This was a post-hoc analysis of the ` Trials of Cilostazol in Symptomatic intracranial arterial stenosis-2 ( TOSS-2 ) ' study , which recruited patients with acute symptomatic ICAS receiving intensive medical treatment .
METHODS	Changes in the status of ICAS were classified as being indicative of regression , progression or no changes .
METHODS	Univariate and multivariate ordinal regression analyses were performed to identify predictors of symptomatic and asymptomatic ICAS based on clinical , laboratory and radiologic data .
RESULTS	Of the 409 patients , symptomatic ICAS demonstrated regression in 110 ( 27 % ) cases and progression in 52 ( 13 % ) cases .
RESULTS	Among these patients , 250 ( 61.1 % ) had asymptomatic ICAS , which regressed in 38 ( 15 % ) cases and progressed in 16 ( 6 % ) cases .
RESULTS	Severe baseline stenosis , a high high-density lipoprotein ( HDL ) cholesterol level and the use of cilostazol were found to be independently associated with a favorable course of symptomatic ICAS ( p0 .001 , p = 0.005 and p = 0.038 , respectively ) .
RESULTS	Regarding asymptomatic ICAS , severe stenosis , the use of angiotensin receptor antagonists and a low fasting glucose level were associated with a favorable course ( p0 .001 , p = 0.011 and p = 0.007 , respectively ) .
CONCLUSIONS	Changes in atherosclerosis are more dynamic in patients with symptomatic ICAS , and the predictors of symptomatic and asymptomatic ICAS differ .
CONCLUSIONS	In this study , changes in the status of symptomatic ICAS were associated with the level of HDL cholesterol , which is known to affect the regression of atherosclerosis and vascular remodeling .

###24912615
BACKGROUND	Selective neck dissection ( SND ) in clinical N0 ( cN0 ) cases of oral squamous cell carcinoma ( SCC ) has been performed by surgeons using a retroauricular or modified facelift approach with robotic or endoscopic assistance .
BACKGROUND	However , these procedures provide cosmetic satisfaction at the cost of possible maximal invasiveness .
BACKGROUND	In this prospective study , we introduced and evaluated the feasibility as well as surgical invasiveness and cosmetic outcome of endoscopically-assisted SND via a small submandibular approach .
METHODS	Forty-four patients with cT1-2N0 oral SCC ( OSCC ) were randomly divided into two groups of endoscopically-assisted SND and conventional SND .
METHODS	Perioperative and postoperative outcomes of patients were evaluated , including the length of the incision , operating time for neck dissection , estimated blood loss during the operation , amount and duration of drainage , total hospitalization period , total number of lymph nodes retrieved , satisfaction scores based on the cosmetic results , perioperative local complications , shoulder syndrome , and follow-up information .
RESULTS	The mean operation time in the endoscopically-assisted group ( 126.0412.67 min ) was longer than that in the conventional group ( 75.6716.67 min ) .
RESULTS	However , the mean length of the incision was 4.330.76 cm in the endoscopically-assisted SND group , and the amount and duration of drainage , total hospital stay , postoperative shoulder pain score , and cosmetic outcomes were superior in the endoscopically-assisted SND group .
RESULTS	Additionally , the retrieved lymph nodes and complications were comparable .
CONCLUSIONS	Endoscopically-assisted SND via a small submandibular approach had a longer operation time than the conventional approach .
CONCLUSIONS	However , endoscopically-assisted SND was feasible and reliable while providing minimal invasiveness and satisfactory appearance .

###25003289
BACKGROUND	The Radiation Therapy Oncology Group 98-11 clinical trial demonstrated the superiority of standard 5-fluorouracil/mitomycin-C over 5-fluorouracil/cisplatin in combination with radiation in the treatment of anal squamous cell cancer .
BACKGROUND	Tumor size ( > 5 cm ) and lymph node metastases are associated with disease progression .
BACKGROUND	There may be key molecular differences ( eg , DNA methylation changes ) in tumors at high risk for progression .
OBJECTIVE	The objectives of this study were to determine whether there are differences in DNA methylation at individual CpG sites and within genes among locally advanced anal cancers , with large tumor size and/or nodal involvement , compared with those that are less advanced .
METHODS	This was a case-case study among 121 patients defined as high risk ( tumor size > 5 cm and/or nodal involvement ; n = 59 ) or low risk ( 5 cm , node negative ; n = 62 ) within the mitomycin-C arm of the Radiation Therapy Oncology Group 98-11 trial .
METHODS	DNA methylation was measured using the Illumina HumanMethylation450 Array .
METHODS	The study was conducted in a tertiary care cancer center in collaboration with a national clinical trials cooperative group .
METHODS	The patients consisted of 74 women and 47 men with a median age of 54 years ( range , 25-79 years ) .
METHODS	DNA methylation differences at individual CpG sites and within genes between low - and high-risk patients were compared using the Mann-Whitney test ( p < 0.001 ) .
RESULTS	A total of 16 CpG loci were differentially methylated ( 14 increased and 2 decreased ) in high - versus low-risk cases .
RESULTS	Genes harboring differentially methylated CpG sites included known tumor suppressor genes and novel targets .
CONCLUSIONS	This study only included patients in the mitomycin-C arm with tumor tissue ; however , this sample was representative of the trial .
CONCLUSIONS	This is the first study to apply genome-wide methylation analysis to anal cancer .
CONCLUSIONS	Biologically relevant differences in methylated targets were found to discriminate locally advanced from early anal cancer .
CONCLUSIONS	Epigenetic events likely play a significant role in the progression of anal cancer and may serve as potential biomarkers .

###25269900
BACKGROUND	Orthotopic liver transplantation ( OLT ) has become the therapeutic option of choice for end-stage liver disease .
BACKGROUND	The aim of this study was to investigate the changes of splenic morphology , signal-to-noise ratio ( SNR ) , contrast-to-noise ratio ( CNR ) , apparent diffusion coefficient ( ADC ) values and explore their value in evaluating the therapeutic effects of orthotopic liver transplantation ( OLT ) on portal hypertension at 1.5 Tesla MRI .
METHODS	Twenty patients with portal hypertension undergoing OLT were included in this study .
METHODS	Conventional MRI and diffusion-weighted image ( DWI ) ( b value = 600 s/mm ( 2 ) ) sequences were applied on each patient before and after OLT , and these patients were referred to as the preoperative and postoperative groups .
METHODS	Twenty healthy individuals were selected as the normal group .
METHODS	After image acquisition , the splenic width ( W ) , thickness ( T ) , length ( L ) , the diameter of the portal vein ( PD ) and splenic vein ( SD ) were measured and the splenic volume ( V ) was calculated .
METHODS	The SNR and CNR were measured on T2WI .
METHODS	The ADC maps were calculated using the b600 in DWIs and the ADC values were measured .
RESULTS	Compared with the preoperative group , the splenic V , PD and SD decreased significantly in the postoperative group ( P < 0.05 ) .
RESULTS	All splenic morphological values were significantly different between preoperative and normal groups ( P < 0.05 ) .
RESULTS	The splenic L and V were significantly different ( P < 0.05 ) between postoperative and normal groups .
RESULTS	The SNR and CNR values were 17.66 4.62 and 13.18 3.12 , 11.50 1.64 and 7.44 4.32 , 4.24 1.24 and 3.03 2.41 in the preoperative , postoperative and normal groups , respectively .
RESULTS	Both SNR and CNR decreased after OLT , but they was still higher than the normal values .
RESULTS	The SNR was significantly different between any two groups ( P < 0.05 ) .
RESULTS	The CNR was significantly different ( P < 0.05 ) between the preoperative and postoperative groups , preoperative and normal groups .
RESULTS	The splenic ADC values were ( 1.339 0.482 ) 10 ( -3 ) mm ( 2 ) / s , ( 1.120 0.254 ) 10 ( -3 ) mm ( 2 ) / s and ( 0.997 0.447 ) 10 ( -3 ) mm ( 2 ) / s in the preoperative , postoperative and normal groups , respectively .
RESULTS	The difference of ADC values were significant ( P < 0.05 ) between the preoperative and postoperative groups , and the preoperative and normal groups .
CONCLUSIONS	OLT is an effective method of treatment for portal hypertension .
CONCLUSIONS	In addition to dramatically decreasing the splenic V , it can also decrease the splenic SNR , CNR and ADC values in patients with portal hypertension .
CONCLUSIONS	The changes of splenic SNR , CNR and ADC after OLT may be helpful in providing noninvasive supplementary information in assessing the therapeutic effect of OLT on portal hypertension .

###24588905
BACKGROUND	Modic changes ( MC ) are associated with low back pain ( LBP ) , but effective treatments are lacking .
BACKGROUND	The aim of this randomized , placebo-controlled , double-blinded trial was to evaluate the efficacy of zoledronic acid ( ZA ) for chronic LBP among patients with MC in magnetic resonance imaging ( MRI ) .
METHODS	Inclusion criteria were LBP lasting 3 months , with an intensity of 6 on a 10-cm VAS or an Oswestry Disability Index ( ODI ) of 30 % , and MC in MRI .
METHODS	Patients were randomized into single intravenous infusion of ZA 5 mg ( n = 20 ) , or placebo ( n = 20 ) groups .
METHODS	The primary outcome was LBP intensity , secondary outcomes leg pain intensity , ODI , health-related quality of life ( RAND-36 ) , lumbar flexibility , sick leaves and use of pain medication .
METHODS	The treatment differences at one month and one year were analysed using ANCOVA with adjustment for the baseline score .
RESULTS	The mean difference ( MD ) between the groups in the primary outcome , intensity of LBP , was 1.4 ( 95 % confidence intervals ( CI ) 0.01 to 2.9 ) in favour of ZA at one month .
RESULTS	We observed no significant between-group difference in the intensity of LBP at one year ( MD 0.7 ; 95 % CI -1.0 to 2.4 ) or in secondary outcomes at any time point except that 20 % of patients in the ZA group used non-steroidal anti-inflammatory drugs at one year compared to 60 % in the placebo group ( P = 0.022 ) .
RESULTS	Acute phase reactions ( fever , flu-like symptoms , arthralgia ) emerged in 95 % of the patients in the ZA group , compared to 35 % in the placebo group .
CONCLUSIONS	ZA was effective in reducing the intensity of LBP in the short term and in reducing the use of NSAIDs within the time span of one year among patients with chronic LBP and MC confirmed in MRI .
CONCLUSIONS	Although the results seem encouraging , larger studies are required to analyse the effectiveness and safety of ZA for patients with MC .
BACKGROUND	ClinicalTrial.gov identifier NCT01330238 .

###25524125
BACKGROUND	Postoperative ileus ( POI ) is a common complication following colorectal surgery that delays recovery and increases length of hospital stay .
BACKGROUND	Gum chewing may reduce POI and therefore enhance recovery after surgery .
BACKGROUND	The aim of the study was to evaluate the effect of gum chewing on POI , length of hospital stay and inflammatory parameters .
METHODS	Patients undergoing elective colorectal surgery in one of two centres were randomized to either chewing gum or a dermal patch ( control ) .
METHODS	Chewing gum was started before surgery and stopped when oral intake was resumed .
METHODS	Primary endpoints were POI and length of stay .
METHODS	Secondary endpoints were systemic and local inflammation , and surgical complications .
METHODS	Gastric emptying was measured by ultrasonography .
METHODS	Soluble tumour necrosis factor receptor 1 ( TNFRSF1A ) and interleukin ( IL ) 8 levels were measured by enzyme-linked immunosorbent assay .
RESULTS	Between May 2009 and September 2012 , 120 patients were randomized to chewing gum ( 58 ) or dermal patch ( control group ; 62 ) .
RESULTS	Mean ( s.d. ) length of hospital stay was shorter in the chewing gum group than in controls , but this difference was not significant : 95 ( 49 ) versus 140 ( 145 ) days respectively .
RESULTS	Some 14 ( 27 per cent ) of 52 analysed patients allocated to chewing gum developed POI compared with 29 ( 48 per cent ) of 60 patients in the control group ( P = 0020 ) .
RESULTS	More patients in the chewing gum group first defaecated within 4 days of surgery ( 85 versus 57 per cent ; P = 0006 ) and passed first flatus within 48h ( 65 versus 50 per cent ; P = 0044 ) .
RESULTS	The decrease in antral area measured by ultrasonography following a standard meal was significantly greater among patients who chewed gum : median 25 ( range -36 to 54 ) per cent compared with 10 ( range -152 to 54 ) per cent in controls ( P = 0004 ) .
RESULTS	Levels of IL-8 ( 133 versus 288pg/ml ; P = 0045 ) and TNFRSF1A ( 074 versus 092ng/ml ; P = 0043 ) were lower among patients in the chewing gum group .
RESULTS	Fewer patients in this group developed a grade IIIb complication ( 2 of 58 versus 10 of 62 ; P = 0031 ) .
CONCLUSIONS	Gum chewing is a safe and simple treatment to reduce POI , and is associated with a reduction in systemic inflammatory markers and complications .
BACKGROUND	NTR2867 ( http://www.trialregister.nl ) .

###24963567
BACKGROUND	Current guidelines recommend at least 24 hours of electrocardiographic ( ECG ) monitoring after an ischemic stroke to rule out atrial fibrillation .
BACKGROUND	However , the most effective duration and type of monitoring have not been established , and the cause of ischemic stroke remains uncertain despite a complete diagnostic evaluation in 20 to 40 % of cases ( cryptogenic stroke ) .
BACKGROUND	Detection of atrial fibrillation after cryptogenic stroke has therapeutic implications .
METHODS	We conducted a randomized , controlled study of 441 patients to assess whether long-term monitoring with an insertable cardiac monitor ( ICM ) is more effective than conventional follow-up ( control ) for detecting atrial fibrillation in patients with cryptogenic stroke .
METHODS	Patients 40 years of age or older with no evidence of atrial fibrillation during at least 24 hours of ECG monitoring underwent randomization within 90 days after the index event .
METHODS	The primary end point was the time to first detection of atrial fibrillation ( lasting > 30 seconds ) within 6 months .
METHODS	Among the secondary end points was the time to first detection of atrial fibrillation within 12 months .
METHODS	Data were analyzed according to the intention-to-treat principle .
RESULTS	By 6 months , atrial fibrillation had been detected in 8.9 % of patients in the ICM group ( 19 patients ) versus 1.4 % of patients in the control group ( 3 patients ) ( hazard ratio , 6.4 ; 95 % confidence interval [ CI ] , 1.9 to 21.7 ; P < 0.001 ) .
RESULTS	By 12 months , atrial fibrillation had been detected in 12.4 % of patients in the ICM group ( 29 patients ) versus 2.0 % of patients in the control group ( 4 patients ) ( hazard ratio , 7.3 ; 95 % CI , 2.6 to 20.8 ; P < 0.001 ) .
CONCLUSIONS	ECG monitoring with an ICM was superior to conventional follow-up for detecting atrial fibrillation after cryptogenic stroke .
CONCLUSIONS	( Funded by Medtronic ; CRYSTAL AF ClinicalTrials.gov number , NCT00924638 . )

###24509422
BACKGROUND	Piriformis muscle injections are most often performed using fluoroscopic guidance ; however , ultrasound ( US ) guidance has recently been described extensively in the literature .
BACKGROUND	No direct comparisons between the 2 techniques have been performed .
BACKGROUND	Our objective was to compare the efficacy and efficiency of fluoroscopic - and US-guided techniques .
METHODS	A randomized , comparative trial was carried out to compare the 2 techniques .
METHODS	Twenty-eight patients with a diagnosis of piriformis syndrome , based on history and physical examination , who had failed conservative treatment were enrolled in the study .
METHODS	Patients were randomized to receive the injection either via US or fluoroscopy .
METHODS	Injections consisted of 10 mL of 1 % lidocaine with 80 mg of triamcinalone .
METHODS	The primary outcome measure was numeric pain score , and secondary outcome measures included functional status as measured by the Multidimensional Pain Inventory , patient satisfaction as measured by the Patient Global Impression of Change scale , and procedure timing characteristics .
METHODS	Outcome data were measured preprocedure , immediately postprocedure , and 1 to 2 weeks and 3 months postprocedure .
RESULTS	We found no statistically significant differences in numeric pain scores , patient satisfaction , procedure timing characteristics , or most functional outcomes when comparing the 2 techniques .
RESULTS	Statistically significant differences between the 2 techniques were found with respect to the outcome measures of household chores and outdoor work .
CONCLUSIONS	Ultrasound-guided piriformis injections provide similar outcomes to fluoroscopically guided injections without differences in imaging , needling , or overall procedural times .

###24684774
OBJECTIVE	The cost implications of the Outcome Reduction with an Initial Glargine Intervention ( ORIGIN ) trial were evaluated using a prespecified analysis plan .
METHODS	Purchasing power parity-adjusted country-specific costs were applied to consumed healthcare resources by participants from each country .
METHODS	Subgroup analyses were conducted on subgroups based on baseline metabolic status and diabetes duration .
RESULTS	The total undiscounted cost per participant in the insulin glargine arm was $ 13,491 ( $ 13,080 to $ 14,254 ) versus $ 11,189 ( $ 10,568 to $ 12,147 ) for standard care , an increase of $ 2303 ( $ 1370 to $ 3235 ; p < 0.0001 ) ; the discounted increase was $ 2099 ( $ 1276 to $ 2923 ; P < 0.0001 ) .
RESULTS	The greater number of mainly generic oral anti-diabetic agents in the standard group partially offset the higher cost of basal insulin glargine .
RESULTS	As the trial progressed and the standard group required more anti-diabetic medications , the annual cost difference decreased , reaching $ 68 ( - $ 160 to $ 295 ) in the last year .
RESULTS	The subgroup whose baseline diabetes duration was 6 years achieved cost-savings during the trial .
CONCLUSIONS	From a global perspective basal insulin glargine use in ORIGIN incurred greater costs than standard care using older generic drugs .
CONCLUSIONS	Nevertheless , the cost difference fell with time such that the intervention was cost-neutral by the last year .

###24687108
OBJECTIVE	Social cognition and interaction training ( SCIT ) has shown promise in improving consumers ' social cognition and functioning , in both inpatient and outpatient settings .
OBJECTIVE	This randomized controlled trial examined the effectiveness of SCIT among persons with serious mental illness living in community settings in Israel .
METHODS	Fifty-five participants in social-mentoring services were assigned randomly to SCIT with social mentoring or to social mentoring only .
METHODS	Emotion recognition , theory of mind , attributional bias , and social functioning were assessed at baseline ( February 2010 ) and about six months later , upon completion of the intervention .
RESULTS	Interactions between time of measurement and group were significant for theory of mind and social engagement .
RESULTS	Emotion recognition by the SCIT group improved significantly , but the time group interaction for this variable was not significant .
CONCLUSIONS	This study provides preliminary evidence that SCIT plus social mentoring improves social cognition and functioning among persons with severe mental illness who are living in the community .

###24571729
BACKGROUND	Health-related and disease-specific quality of life ( HRQoL ) has been increasingly valued as relevant clinical parameter in cystic fibrosis ( CF ) clinical care and clinical trials .
BACKGROUND	HRQoL measures should assess - among other domains - daily functioning from a patient 's perspective .
BACKGROUND	However , validation studies for the most frequently used HRQoL questionnaire in CF , the Cystic Fibrosis Questionnaire ( CFQ ) , have not included measures of physical activity or fitness .
BACKGROUND	The objective of this study was , therefore , to determine the cross-sectional and longitudinal relationships between HRQoL , physical activity and fitness in patients with CF.
METHODS	Baseline ( n = 76 ) and 6-month follow-up data ( n = 70 ) from patients with CF ( age 12 years , FEV1 35 % ) were analysed .
METHODS	Patients participated in two multi-centre exercise intervention studies with identical assessment methodology .
METHODS	Outcome variables included HRQoL ( German revised multi-dimensional disease-specific CFQ ( CFQ-R ) ) , body composition , pulmonary function , physical activity , short-term muscle power , and aerobic fitness by peak oxygen uptake and aerobic power .
RESULTS	Peak oxygen uptake was positively related to 7 of 13 HRQoL scales cross-sectionally ( r = 0.30-0 .46 ) .
RESULTS	Muscle power ( r = 0.25-0 .32 ) and peak aerobic power ( r = 0.24-0 .35 ) were positively related to 4 scales each , and reported physical activity to 1 scale ( r = 0.29 ) .
RESULTS	Changes in HRQoL-scores were directly and significantly related to changes in reported activity ( r = 0.35-0 .39 ) , peak aerobic power ( r = 0.31-0 .34 ) , and peak oxygen uptake ( r = 0.26-0 .37 ) in 3 scales each .
RESULTS	Established associates of HRQoL such as FEV1 or body mass index correlated positively with fewer scales ( all 0.24 < r < 0.55 ) .
CONCLUSIONS	HRQoL was associated with physical fitness , especially aerobic fitness , and to a lesser extent with reported physical activity .
CONCLUSIONS	These findings underline the importance of physical fitness for HRQoL in CF and provide an additional rationale for exercise testing in this population .
BACKGROUND	ClinicalTrials.gov , NCT00231686 .

###24667994
OBJECTIVE	To compare the efficacy and safety of single-dose bimatoprost 0.03 % / timolol 0.5 % preservative-free ( PF ) ophthalmic solution with bimatoprost 0.03 % / timolol 0.5 % ophthalmic solution in patients with open-angle glaucoma or ocular hypertension .
METHODS	In this multicentre , randomised , parallel-group study , patients were randomised to bimatoprost/timolol PF or bimatoprost/timolol once daily in the morning for 12 weeks .
METHODS	Primary efficacy endpoints , reflecting differing regional regulatory requirements , included change from baseline in worse eye intraocular pressure ( IOP ) in the per-protocol population at week 12 , and the average eye IOP at weeks 2 , 6 and 12 in the intent-to-treat population .
RESULTS	561 patients were randomised ( 278 to bimatoprost/timolol PF ; 283 to bimatoprost/timolol ) ; 96.3 % completed the study .
RESULTS	Both treatment groups showed statistically and clinically significant mean decreases from baseline in worse eye IOP and in average eye IOP at all follow-up time points ( p < 0.001 ) .
RESULTS	Bimatoprost/timolol PF met all pre-established criteria for non-inferiority and equivalence to bimatoprost/timolol .
RESULTS	Ocular adverse events were similar between treatment groups , with conjunctival hyperaemia being the most frequent .
RESULTS	Most were mild or moderate in severity .
CONCLUSIONS	Bimatoprost/timolol PF demonstrated non-inferiority and equivalence in IOP lowering compared with bimatoprost/timolol , with no significant differences in safety and tolerability .
BACKGROUND	NCT01177098 .

###25059340
BACKGROUND	Current guidelines recommend treatment of significant coronary artery disease by concomitant coronary artery bypass grafting ( CABG ) in patients undergoing surgical aortic valve replacement .
BACKGROUND	However there is no consensus as to how best to treat coronary disease in high-risk patients requiring transcatheter aortic valve implantation ( TAVI ) .
METHODS	The percutaneous coronary intervention prior to transcatheter aortic valve implantation ( ACTIVATION ) trial is a randomized , controlled open-label trial of 310 patients randomized to treatment of significant coronary artery disease by percutaneous coronary intervention ( PCI - test arm ) or no PCI ( control arm ) .
METHODS	Significant coronary disease is defined as 1 lesion of 70 % severity in a major epicardial vessel or 50 % in a vein graft or protected left main stem lesion .
METHODS	The trial tests the hypothesis that the strategy of performing pre-TAVI PCI is non-inferior to not treating such coronary stenoses with PCI prior to TAVI , with a composite primary outcome of 12-month mortality and rehospitalization .
METHODS	Secondary outcomes include efficacy end-points such as 30-day mortality , safety endpoints including bleeding , burden of symptoms , and quality of life ( assessed using the Seattle Angina Questionnaire and the Kansas City Cardiomyopathy Questionnaire ) .
METHODS	In conclusion , we hope that using a definition of coronary artery disease severity closer to that used in everyday practice by interventional cardiologists - rather than the 50 % severity used in surgical guidelines - will provide robust evidence to direct guidelines regarding TAVI therapy and improve its safety and efficacy profile of this developing technique .
BACKGROUND	ISRCTN75836930 , http://www.controlled-trials.com/ISRCTN75836930 ( registered 19 November 2011 ) .

###25626751
BACKGROUND	Some characteristics of assessments exert a strong influence on how students study .
BACKGROUND	Understanding these pre-assessment learning effects is of key importance to the designing of medical assessments that foster students ' reasoning abilities .
BACKGROUND	Perceptions of the task demands of an assessment significantly influence students ' cognitive processes .
BACKGROUND	However , why and how certain tasks positively ` drive ' learning remain unknown .
BACKGROUND	Medical tasks can be assessed as coherent meaningful whole tasks ( e.g. examining a patient based on his complaint to find the diagnosis ) or can be divided into simpler part tasks ( e.g. demonstrating the physical examination of a pre-specified disease ) .
BACKGROUND	Comparing the benefits of whole-task and part-task assessments in a randomised controlled experiment could guide the design of ` assessments for learning ' .
OBJECTIVE	The purpose of this study was to determine whether the knowledge that an objective structured clinical examination ( OSCE ) will contain whole tasks , as opposed to part tasks , increases the use of diagnostic reasoning by medical students when they study for this assessment .
METHODS	In this randomised , controlled , mixed-methods experiment , 40 medical students were randomly paired and filmed while studying together for two imminent physical examination OSCE stations .
METHODS	Each 25-minute study period began with video cues and ended with a questionnaire on cognitive loads .
METHODS	Cues disclosed either a part-task OSCE station ( examination of a healthy patient ) or a whole-task OSCE station ( hypothesis-driven physical examination [ HDPE ] ) .
METHODS	In a crossover design , sequences were randomised for both task and content ( shoulder or spine ) .
METHODS	Two blinded and independent authors scored all 40 videos in distinct randomised orders , listening to participants studying freely .
METHODS	Mentioning a diagnosis in association with a sign was scored as a backward association , and the opposite was scored as a forward association ; both revealed the use of diagnostic reasoning .
METHODS	Qualitative data were obtained through group interviews .
RESULTS	Studying for whole-task OSCE stations resulted in a greater use of diagnostic reasoning .
RESULTS	Qualitative data triangulate these findings and show the precedence of cues sourced from the ` student grapevine ' .
CONCLUSIONS	In comparison with ` traditional ' part-task OSCEs , whole-task OSCEs like the HDPE increase students ' use of diagnostic reasoning during study time .

###24720703
BACKGROUND	The interferon-free combination of the protease inhibitor ABT-450 with ritonavir ( ABT-450 / r ) and the NS5A inhibitor ombitasvir ( also known as ABT-267 ) plus the nonnucleoside polymerase inhibitor dasabuvir ( also known as ABT-333 ) and ribavirin has shown efficacy against the hepatitis C virus ( HCV ) in patients with HCV genotype 1 infection .
BACKGROUND	In this phase 3 trial , we evaluated this regimen in previously untreated patients with HCV genotype 1 infection and no cirrhosis .
METHODS	In this multicenter , randomized , double-blind , placebo-controlled trial , we assigned previously untreated patients with HCV genotype 1 infection , in a 3:1 ratio , to an active regimen consisting of a single-tablet coformulation of ABT-450 / r-ombitasvir ( at a once-daily dose of 150 mg of ABT-450 , 100 mg of ritonavir , and 25 mg of ombitasvir ) , and dasabuvir ( 250 mg twice daily ) with ribavirin ( in doses determined according to body weight ) ( group A ) or matching placebos ( group B ) .
METHODS	The patients received the study treatment during a 12-week double-blind period .
METHODS	The primary end point was sustained virologic response at 12 weeks after the end of treatment .
METHODS	The primary analysis compared the response rate in group A with the response rate ( 78 % ) in a historical control group of previously untreated patients without cirrhosis who received telaprevir with peginterferon and ribavirin .
METHODS	Adverse events occurring during the double-blind period were compared between group A and group B.
RESULTS	A total of 631 patients received at least one dose of the study drugs .
RESULTS	The rate of sustained virologic response in group A was 96.2 % ( 95 % confidence interval , 94.5 to 97.9 ) , which was superior to the historical control rate .
RESULTS	Virologic failure during treatment and relapse after treatment occurred in 0.2 % and 1.5 % , respectively , of the patients in group A.
RESULTS	The response rates in group A were 95.3 % among patients with HCV genotype 1a infection and 98.0 % among those with HCV genotype 1b infection .
RESULTS	The rate of discontinuation due to adverse events was 0.6 % in each study group .
RESULTS	Nausea , pruritus , insomnia , diarrhea , and asthenia occurred in significantly more patients in group A than in group B ( P < 0.05 for all comparisons ) .
RESULTS	Reductions in the hemoglobin level were all of grade 1 or 2 ; reductions of grade 1 and 2 occurred in 47.5 % and 5.8 % , respectively , of the patients in group A , whereas grade 1 reductions occurred in 2.5 % of the patients in group B.
CONCLUSIONS	In previously untreated patients with HCV genotype 1 infection and no cirrhosis , a 12-week multitargeted regimen of ABT-450 / r-ombitasvir and dasabuvir with ribavirin was highly effective and was associated with a low rate of treatment discontinuation .
CONCLUSIONS	( Funded by AbbVie ; SAPPHIRE-I ClinicalTrials.gov number , NCT01716585 . )

###25103718
OBJECTIVE	Cognitive interventions increasingly complement psychopharmacological treatment to enhance symptomatic and functional outcome in schizophrenia .
OBJECTIVE	Metacognitive training ( MCT ) is targeted at cognitive biases involved in the pathogenesis of delusions .
OBJECTIVE	To examine the long-term efficacy of group MCT for schizophrenia in order to explore whether previously established effects were sustained .
METHODS	A 2-center , randomized , controlled , assessor-blind , parallel group trial was conducted .
METHODS	A total of 150 inpatients or outpatients with DSM-IV diagnoses of schizophrenia spectrum disorders were enrolled .
METHODS	All patients were prescribed antipsychotic medication .
METHODS	The second follow-up assessment took place 3 years later after the intervention phase was terminated .
METHODS	Group MCT targeting cognitive biases vs neuropsychological training ( COGPACK ) .
METHODS	Patients received a maximum of 16 sessions .
METHODS	The primary outcome measure was a delusion score derived from the Positive and Negative Syndrome Scale ( PANSS ) .
METHODS	The PANSS positive syndrome and total scores , the Psychotic Symptom Rating Scales , the jumping to conclusions bias , self-esteem , and quality of life served as secondary outcome measures .
RESULTS	The intention-to-treat analyses demonstrated that patients in the MCT group had significantly greater reductions in the core PANSS delusion score , after 3 years compared with the control group ( 2partial = .037 ; P = .05 ) .
RESULTS	Among the secondary outcomes , the intention-to-treat analyses also demonstrated that patients in the MCT group had significantly greater reductions in the PANSS positive syndrome score ( 2partial = .055 ; P = .02 ) and the Psychotic Symptom Rating Scales delusion score ( 2partial = .109 ; P = .001 ) .
RESULTS	Significant group differences at the 3-year follow-up were also found on measures of self-esteem and quality of life , which did not distinguish groups at earlier assessment points .
RESULTS	Attention was improved in the neuropsychological training group relative to the MCT group .
RESULTS	The completion rate was 61.3 % after 3 years .
CONCLUSIONS	Metacognitive training demonstrated sustained effects in the reduction of delusions , which were over and above the effects of antipsychotic medication .
CONCLUSIONS	Moreover , there were some unanticipated ( `` sleeper '' ) effects as both self-esteem and quality of life were improved after 3 years .
CONCLUSIONS	Effects on self-esteem and well-being were found even in the absence of an improvement on the jumping to conclusions bias .
BACKGROUND	isrctn.org Identifier : ISRCTN95205723 .

###24652053
BACKGROUND	Metabolic syndrome is a complex disorder represented by a set of cardiovascular risk factors .
BACKGROUND	A healthy lifestyle is strongly related to improve Quality of Life and interfere positively in the control of risk factors presented in this condition .
OBJECTIVE	To evaluate the effect of a program of lifestyle modification on the Framingham General Cardiovascular Risk Profile in subjects diagnosed with metabolic syndrome .
METHODS	A sub-analysis study of a randomized clinical trial controlled blind that lasted three months .
METHODS	Participants were randomized into four groups : dietary intervention + placebo ( DIP ) , dietary intervention + supplementation of omega 3 ( fish oil 3 g/day ) ( DIS3 ) , dietary intervention + placebo + physical activity ( DIPE ) and dietary intervention + physical activity + supplementation of omega 3 ( DIS3PE ) .
METHODS	The general cardiovascular risk profile of each individual was calculated before and after the intervention .
RESULTS	The study included 70 subjects .
RESULTS	Evaluating the score between the pre and post intervention yielded a significant value ( p < 0.001 ) .
RESULTS	We obtained a reduction for intermediate risk in 25.7 % of subjects .
RESULTS	After intervention , there was a significant reduction ( p < 0.01 ) on cardiovascular age , this being more significant in groups DIP ( 5.2 % ) and DIPE ( 5.3 % ) .
CONCLUSIONS	Proposed interventions produced beneficial effects for reducing cardiovascular risk score .
CONCLUSIONS	This study emphasizes the importance of lifestyle modification in the prevention and treatment of cardiovascular diseases .

###24548399
OBJECTIVE	To explore the efficacy and safety of recombinant tissue plasminogen activator ( rt-PA ) in thrombolytic therapy of vena caval thromboembolism .
METHODS	Ninety patients diagnosed of vena caval thromboembolism by ultrasound or angiography of inferior vena cava were randomly assigned into 2 groups .
METHODS	rt-PA and parental anticoagulant were given to the patients in the treatment group while those in the control group received only parental anticoagulation .
METHODS	D-dimer , fibrinogen and fibrinogen degradation product were analyzed after 2-week treatment .
METHODS	All subjects were closely monitored for the occurrence of severe complications .
RESULTS	The changes from baseline in the above laboratory parameters in the treatment group were significantly greater than those of the control group ( P < 0.05 ) .
RESULTS	No severe complications occurred in either group .
CONCLUSIONS	rt-PA is both safe and effective for the thrombolytic therapy of vena caval thromboembolism .

###24463577
OBJECTIVE	Intimate partner violence ( IPV ) is a common , costly societal problem .
OBJECTIVE	Interventions designed to reduce IPV recidivism have had limited success but primary prevention efforts are likely to be more effective in reducing the occurrence of IPV .
OBJECTIVE	The purpose of this study was to examine the impact of a computer-based preventive intervention ( ePREP ) on IPV in a sample of married , community couples .
METHODS	We employed a randomized clinical trial design comparing ePREP to an active placebo control group .
METHODS	Using a community sample of 52 married couples ( 21 % Black , 3 % Asian , 65 % White , 7 % Latino , 4 % Mixed/biracial ) who had been married , on average , 4.3 years , we examined the impact ePREP on IPV as measured by self and partner reports of the Revised Conflict Tactics Scale .
METHODS	We assessed couples at baseline , six-weeks post-baseline , and one-year post-baseline .
METHODS	We used the Actor Partner Interdependence Model with treatment effects to analyze the obtained dyadic data .
RESULTS	We found that ePREP reduced physical and psychological aggression among married couples ( on average across informants , a 90 % reduction in expected counts of physical aggression , and a 0.18 standard deviation reduction in psychological aggression ) and that these gains were maintained at a 1-year follow-up assessment .
CONCLUSIONS	Interventions that can be delivered widely and at a low-cost will increase the likelihood of reaching those who will benefit most from receiving them .
CONCLUSIONS	Implications for implementing flexible interventions and changing our approach to treatment delivery are discussed .

###24383602
OBJECTIVE	Dexmedetomidine ( D ) can prolong the duration of local anesthetics , but the effect of caudal dexmedetomidine on the potency of levobupivacaine ( L ) for caudal block has not been investigated .
OBJECTIVE	This study was designed to determine the effect of caudal dexmedetomidine on levobupivacaine for caudal block in pediatric patients .
METHODS	Eighty-nine children scheduled for elective inguinal hernia repair or hydrocele were randomly assigned to one of the three groups : Group L ( caudal levobupivacaine ) , Group LD1 ( levobupivacaine plus 1gkg ( -1 ) dexmedetomidine ) , or Group LD2 ( levobupivacaine plus 2gkg ( -1 ) dexmedetomidine ) .
METHODS	The primary endpoint was the minimum local anesthetic concentration ( MLAC ) , which was determined using the Dixon up-and-down method .
METHODS	The secondary endpoints were the duration of analgesia and sedation .
RESULTS	The MLAC values ( sd ) of caudal levobupivacaine were 0.103 ( 0.01 ) % , 0.068 ( 0.02 ) % , and 0.055 ( 0.03 ) % in Groups L , LD1 , and LD2 , respectively .
RESULTS	The values of EC50 and EC95 ( 95 % CI ) of caudal levobupivacaine from logistic regression analysis were 0.094 ( 0.083-0 .105 ) % and 0.129 ( 0.1-0 .159 ) % , 0.058 ( 0.044-0 .072 ) % and 0.106 ( 0.067-0 .144 ) % , and 0.046 ( 0.033-0 .059 ) % and 0.091 ( 0.055-0 .127 ) % in Groups L , LD1 , and LD2 , respectively .
RESULTS	The mean durations of analgesia in the postoperative period were 141 , 378 , and 412min in Groups L , LD1 , and LD2 , respectively ( L vs LD1 or LD2 , P < 0.001 ) .
RESULTS	The mean durations of sedation in both Groups LD1 and LD2 also were significantly prolonged , compared with Group L ( P < 0.01 ) .
CONCLUSIONS	Caudal dexmedetomidine reduces the MLAC values of levobupivacaine and improves postoperative analgesia in children without any neurological side effects .

###25558545
OBJECTIVE	Commercial diving often occurs in low visibility , where divers are reliant on their tactile senses .
OBJECTIVE	This study examined the effect of nitrogen narcosis on tactile memory for shapes as well as the influence of psychological and biographical factors on this relationship .
METHODS	This crossover study tested 139 commercial divers in a dry hyperbaric chamber at 101.325 and 607.95 kPa ( 1 and 6 atmospheres absolute/atm abs ) .
METHODS	Divers memorized shapes while blindfolded , using their tactile senses only .
METHODS	Delayed recall was measured at the surface after each dive .
METHODS	Psychological and biographical data were also collected .
RESULTS	A significant effect of hyperbaric pressure on tactile memory was demonstrated , and a further effect of sequence of testing found .
RESULTS	Thus , divers ' delayed shape recall deteriorated by 8 % after learning material at depth , compared to learning on the surface .
RESULTS	There were also significant but small effects of psychological and biographical markers on tactile memory performance , with lower trait anxiety associated with better recall , and lower education associated with poorer recall .
CONCLUSIONS	The findings emphasize the importance of utilizing other forms of recording of events or objects at depth , particularly in conditions of low visibility during deeper diving , to aid memory encoding and subsequent recall at the surface .

###25103848
OBJECTIVE	Children born prematurely who develop retinopathy of prematurity ( ROP ) often develop myopia , and those who require laser treatment may develop very high myopia , which has considerable clinical consequences .
OBJECTIVE	To report refractive outcomes in preterm infants who developed ROP in zone I or zone II posterior as stage 3 + ROP or aggressive posterior ROP ( APROP ) .
METHODS	All infants received intravitreal bevacizumab or laser therapy in a prospective , stratified , randomized , controlled , masked , multicenter clinical trial , Bevacizumab Eliminates the Angiogenic Threat for ROP ( BEAT-ROP ) .
METHODS	Children who received intravitreal bevacizumab or laser in the BEAT-ROP clinical trial , with treatment randomized by infant , underwent cycloplegic retinoscopic refraction at a mean age of 2 years .
METHODS	Fifteen centers with both pediatric and vitreoretinal ophthalmologists participating in level 3 neonatal intensive care units in academic centers with institutional review board approval were included in the trial .
METHODS	Of the originally enrolled 150 infants ( 300 eyes ) in the BEAT-ROP clinical trial , 13 infants ( 26 eyes ) died ( 6 received intravitreal bevacizumab ; 7 received laser ) and 19 eyes had intraocular surgery ( 6 infants bilaterally ) .
METHODS	Thus , 45 eyes ( 19 infants bilaterally ) were excluded , leaving 131 infants ( 255 eyes , including 21 eyes that received a successful second treatment for recurrence ) .
METHODS	Follow-up of the BEAT-ROP cohort .
METHODS	Spherical equivalent refractive outcomes and their distribution by ROP zone and treatment .
RESULTS	Refractions were available for 109 of 131 eligible infants ( 83.2 % ) and 211 of 255 eyes ( 82.7 % ) .
RESULTS	Mean ( SD ) spherical equivalent refractions were as follows : zone I , -1.51 ( 3.42 ) diopters ( D ) in 52 eyes that received intravitreal bevacizumab and -8.44 ( 7.57 ) D in 35 eyes that received laser treatment ( P < .001 ) ; and zone II posterior , -0.58 ( 2.53 ) D in 58 eyes that received intravitreal bevacizumab and -5.83 ( 5.87 ) D in 66 eyes that received laser treatment ( P < .001 ) .
RESULTS	Very high myopia ( -8.00 D ) occurred in zone I in 2 of 52 ( 3.8 % ) eyes that received intravitreal bevacizumab and in 18 of 35 ( 51.4 % ) eyes that received laser treatment ( P < .001 ) .
RESULTS	Very high myopia occurred in zone II posterior in 1 of 58 ( 1.7 % ) eyes that received intravitreal bevacizumab and in 24 of 66 ( 36.4 % ) eyes that received laser treatment ( P < .001 ) .
CONCLUSIONS	More very high myopia was found in eyes that received laser treatment than in eyes that received intravitreal bevacizumab .
CONCLUSIONS	This difference is possibly related to anterior segment development that is present with intravitreal bevacizumab but minimal or absent following laser treatment .
BACKGROUND	clinicaltrials.gov Identifier : NCT00622726 .

###25693333
BACKGROUND	Efficacy and safety of sugammadex in reversing neuromuscular block induced by rocuronium or vecuronium were investgated in Japanese patients .
METHODS	We studied 99 Japanese patients undergoing surgery requiring general anesthesia .
METHODS	Patients were allocated randomly to receive intubation dose of rocuronium or vecuronium .
METHODS	During surgery , patients received additional dose of rocuronium or vecuronium for maintenance of deep block .
METHODS	At 1-2 PTC , 0.5-8 .0 mg .
METHODS	kg-1 of sugammadex was administered .
METHODS	The neuromuscular block was monitored with acceleromyography using TOF stimuli .
METHODS	Sevoflurane was administered to all treatment groups after intubation .
RESULTS	For the rocuronium-induced neuromuscular block , the mean recovery time of the T4/T1 ratio to 0.9 decreased from 66.9 min in the sugammadex 0.5 mg kg-1 group to 1.3 min in the sugammadex 8.0 mg kg-1 group .
RESULTS	For the vecuronium-induced neuromuscular block it decreased from 79.5 min in the sugammadex 0.5 mg .
RESULTS	kg-1 group to 2.9 min in the sugammadex 8.0 mg .
RESULTS	kg-1 group .
RESULTS	No clinical evidence of recurarization or residual curarization was observed .
CONCLUSIONS	The efficacy and safety of sugammadex were confirmed in Japanese surgical patients for reversal from deep block .

###24221577
BACKGROUND	Few treatments have the potential to reduce the severity of radiation-induced mucositis in head and neck cancer patients .
BACKGROUND	Some small studies have suggested that organic honey may be a useful preventive treatment .
METHODS	This investigator-initiated double-blind randomized placebo-controlled trial investigated whether honey reduced the severity of radiation-induced oral mucositis ( ROM ) .
METHODS	One hundred six head and neck cancer patients from the Vancouver and Sudbury Cancer Centers in Canada were randomized to swish , hold , and swallow either 5 ml of irradiated organic manuka honey or a placebo gel , four times a day throughout radiation treatment , plus seven more days .
METHODS	Severity of oral mucositis according to the Radiation Therapy Oncology Group ( RTOG ) , World Health Organization ( WHO ) , and Oral Mucositis Assessment Scale scales , weight , and subjects ' symptom severity and quality of life were assessed weekly .
METHODS	Sialometry was performed at baseline and at the last study visit .
RESULTS	One hundred six patients were recruited .
RESULTS	Twenty-four did not attend any mucositis assessments .
RESULTS	One was removed from the study because of off-study consumption of store-bought manuka honey .
RESULTS	The remaining 81 patients had at least one mucositis assessment and were included in the analysis .
RESULTS	Sixty-two percent of subjects received concurrent chemotherapy ; 81 % were male .
RESULTS	The groups were well-matched , and blinding was excellent .
RESULTS	Dropouts were mostly due to nausea and were similar in both arms , with 78 % being able to tolerate the study products for more than 1 week .
RESULTS	The dropout rate was 57 % in those who received honey and 52 % in those who received placebo gel .
RESULTS	The dropout rate in those who had concurrent chemotherapy was 59 % and in those who only received radiation was 47 % .
RESULTS	There was no statistically significant difference between the honey and placebo arms in any of the outcome indicators .
RESULTS	Those who completed the study in both treatment arms had low rates of RTOG greater than or equal to grade 3 mucositis ; 35 % in the honey group and 43 % in the placebo group .
CONCLUSIONS	Despite promising earlier reports , manuka honey was not tolerated well by our patients and , even when used as directed , did not have a significant impact on the severity of ROM .

###24257410
BACKGROUND	Indigenous Australian youth ( aged 15 to 34 ) have up to four times the risk of suicide compared with their non-Indigenous counterparts .
BACKGROUND	Barriers to help-seeking include shame , feared loss of autonomy and negative attitudes towards healthcare providers .
BACKGROUND	The use of mobile devices and apps continues to rise amongst young people , thus presenting opportunities to utilize these aids in overcoming help-seeking barriers .
BACKGROUND	Apps have been shown to assist in several health-related areas , including weight loss and smoking cessation , although no apps have as yet been evaluated for suicide prevention .
BACKGROUND	Moreover , there is a lack of research that scientifically evaluates suicide prevention interventions within Indigenous communities .
METHODS	In this study , a recently developed self-help app will be evaluated in a randomized controlled trial .
METHODS	The intervention is based on acceptance and commitment therapy and mindfulness-based cognitive behavioural therapy .
METHODS	It is aimed at participants who have suicidal thoughts but who are not actively suicidal .
METHODS	In total , 150 participants will be randomly allocated to the intervention-condition ( N = 75 ) or to the wait-list control condition ( N = 75 ) .
METHODS	Questionnaires will be completed at baseline , post-test and 6 weeks follow-up .
METHODS	The primary outcome measure is a reduction in frequency and intensity of suicidal thoughts .
METHODS	Secondary outcome measures are the reduction of depression , anxiety and impulsivity .
CONCLUSIONS	This study is the first to evaluate the effectiveness of a self-help app for suicidal thoughts amongst young Indigenous people .
CONCLUSIONS	Several limitations and strengths of the design are discussed .
BACKGROUND	Australian New Zealand Clinical Trials Registry ( ANZCTR ) : ACTRN12613000104752 .

###24907874
OBJECTIVE	Few investigations have addressed the safety of oxygen from concentrators for use in anesthesia in association with nitrous oxide .
OBJECTIVE	This study evaluated the percent of oxygen from a concentrator in association with nitrous oxide in a semi-closed rebreathing circuit .
METHODS	Adult patients undergoing low risk surgery were randomly allocated into two groups , receiving a fresh gas flow of oxygen from concentrators ( O293 ) or of oxygen from concentrators and nitrous oxide ( O293N2O ) .
METHODS	The fraction of inspired oxygen and the percentage of oxygen from fresh gas flow were measured every 10 min .
METHODS	The ratio of FiO2/oxygen concentration delivered was compared at various time intervals and between the groups .
RESULTS	Thirty patients were studied in each group .
RESULTS	There was no difference in oxygen from concentrators over time for both groups , but there was a significant improvement in the FiO2 ( p < 0.001 ) for O293 group while a significant decline ( p < 0.001 ) for O293N2O .
RESULTS	The FiO2/oxygen ratio varied in both groups , reaching a plateau in the O293 group .
RESULTS	Pulse oximetry did not fall below 98.5 % in either group .
CONCLUSIONS	The FiO2 in the mixture of O293 and nitrous oxide fell during the observation period although oxygen saturation was higher than 98.5 % throughout the study .
CONCLUSIONS	Concentrators can be considered a stable source of oxygen for use during short anesthetic procedures , either pure or in association with nitrous oxide at 50:50 volume .

###25631070
BACKGROUND	Conflicting blood pressure-lowering effects of catheter-based renal artery denervation have been reported in patients with resistant hypertension .
BACKGROUND	We compared the ambulatory blood pressure-lowering efficacy and safety of radiofrequency-based renal denervation added to a standardised stepped-care antihypertensive treatment ( SSAHT ) with the same SSAHT alone in patients with resistant hypertension .
METHODS	The Renal Denervation for Hypertension ( DENERHTN ) trial was a prospective , open-label randomised controlled trial with blinded endpoint evaluation in patients with resistant hypertension , done in 15 French tertiary care centres specialised in hypertension management .
METHODS	Eligible patients aged 18-75 years received indapamide 15 mg , ramipril 10 mg ( or irbesartan 300 mg ) , and amlodipine 10 mg daily for 4 weeks to confirm treatment resistance by ambulatory blood pressure monitoring before randomisation .
METHODS	Patients were then randomly assigned ( 1:1 ) to receive either renal denervation plus an SSAHT regimen ( renal denervation group ) or the same SSAHT alone ( control group ) .
METHODS	The randomisation sequence was generated by computer , and stratified by centres .
METHODS	For SSAHT , after randomisation , spironolactone 25 mg per day , bisoprolol 10 mg per day , prazosin 5 mg per day , and rilmenidine 1 mg per day were sequentially added from months two to five in both groups if home blood pressure was more than or equal to 135/85 mm Hg .
METHODS	The primary endpoint was the mean change in daytime systolic blood pressure from baseline to 6 months as assessed by ambulatory blood pressure monitoring .
METHODS	The primary endpoint was analysed blindly .
METHODS	The safety outcomes were the incidence of acute adverse events of the renal denervation procedure and the change in estimated glomerular filtration rate from baseline to 6 months .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01570777 .
RESULTS	Between May 22 , 2012 , and Oct 14 , 2013 , 1416 patients were screened for eligibility , 106 of those were randomly assigned to treatment ( 53 patients in each group , intention-to-treat population ) and 101 analysed because of patients with missing endpoints ( 48 in the renal denervation group , 53 in the control group , modified intention-to-treat population ) .
RESULTS	The mean change in daytime ambulatory systolic blood pressure at 6 months was -158 mm Hg ( 95 % CI -197 to -119 ) in the renal denervation group and -99 mm Hg ( -136 to -62 ) in the group receiving SSAHT alone , a baseline-adjusted difference of -59 mm Hg ( -113 to -05 ; p = 00329 ) .
RESULTS	The number of antihypertensive drugs and drug-adherence at 6 months were similar between the two groups .
RESULTS	Three minor renal denervation-related adverse events were noted ( lumbar pain in two patients and mild groin haematoma in one patient ) .
RESULTS	A mild and similar decrease in estimated glomerular filtration rate from baseline to 6 months was observed in both groups .
CONCLUSIONS	In patients with well defined resistant hypertension , renal denervation plus an SSAHT decreases ambulatory blood pressure more than the same SSAHT alone at 6 months .
CONCLUSIONS	This additional blood pressure lowering effect may contribute to a reduction in cardiovascular morbidity if maintained in the long term after renal denervation .
BACKGROUND	French Ministry of Health .

###25833969
BACKGROUND	Previously published research that examined the effects of high egg consumption in people with type 2 diabetes ( T2D ) produced conflicting results leading to recommendations to limit egg intake .
BACKGROUND	However , people with T2D may benefit from egg consumption because eggs are a nutritious and convenient way of improving protein and micronutrient contents of the diet , which have importance for satiety and weight management .
OBJECTIVE	In this randomized controlled study , we aimed to determine whether a high-egg diet ( 2 eggs/d for 6 d/wk ) compared with a low-egg diet ( < 2 eggs/wk ) affected circulating lipid profiles , in particular high-density lipoprotein ( HDL ) cholesterol , in overweight or obese people with prediabetes or T2D .
METHODS	A total of 140 participants were randomly assigned to one of the 2 diets as part of a 3-mo weight maintenance study .
METHODS	Participants attended the clinic monthly and were instructed on the specific types of foods and quantities to be consumed .
RESULTS	There was no significant difference in the change in HDL cholesterol from screening to 3 mo between groups ; the mean difference ( 95 % CI ) between high - and low-egg groups was +0.02 mmol/L ( -0.03 , 0.08 mmol/L ; P = 0.38 ) .
RESULTS	No between-group differences were shown for total cholesterol , low-density lipoprotein cholesterol , triglycerides , or glycemic control .
RESULTS	Both groups were matched for protein intake , but the high-egg group reported less hunger and greater satiety postbreakfast .
RESULTS	Polyunsaturated fatty acid ( PUFA ) and monounsaturated fatty acid ( MUFA ) intakes significantly increased from baseline in both groups .
CONCLUSIONS	High egg consumption did not have an adverse effect on the lipid profile of people with T2D in the context of increased MUFA and PUFA consumption .
CONCLUSIONS	This study suggests that a high-egg diet can be included safely as part of the dietary management of T2D , and it may provide greater satiety .
CONCLUSIONS	This trial was registered at the Australia New Zealand Clinical Trials Registry ( http://www.anzctr.org.au/ ) as ACTRN12612001266853 .

###24298907
BACKGROUND	Patients with Mycobacterium avium complex pulmonary disease are frequently administered a combination of clarithromycin , ethambutol , and rifampicin .
BACKGROUND	However , rifampicin is known to reduce the serum levels of clarithromycin .
BACKGROUND	It remains unclear whether a reduction in clarithromycin serum levels influences the clinical outcome of the Mycobacterium avium complex pulmonary disease treatment regimen .
OBJECTIVE	To compare a three-drug regimen ( clarithromycin , ethambutol , and rifampicin ) to a two-drug regimen ( clarithromycin and ethambutol ) for the treatment of Mycobacterium avium lung disease .
METHODS	In a preliminary open-label study , we randomly assigned newly diagnosed , but as-yet untreated , patients with disease caused by Mycobacterium avium complex without HIV infection to either the three-drug or the two-drug regimen for 12 months .
METHODS	The primary endpoint was the conversion of sputum cultures to negative after 12 months of treatment .
METHODS	Patient data were analyzed using the intention-to-treat method .
RESULTS	Of 119 eligible patients , 59 were assigned to the three-drug regimen and 60 to the two-drug regimen .
RESULTS	The rate of sputum culture conversion was 40.6 % with the three-drug regimen and 55.0 % with the two-drug regimen ( difference , -14.4 % [ 95 % confidence interval , -32.1 to 3.4 ] ) .
RESULTS	The incidence of adverse events leading to the discontinuation of treatment was 37.2 and 26.6 % for the three-drug and the two-drug regimens , respectively .
CONCLUSIONS	This preliminary study suggests that treatment with clarithromycin and ethambutol is not inferior to treatment with clarithromycin , ethambutol , and rifampicin for Mycobacterium avium complex lung disease .
CONCLUSIONS	Our findings justify a larger clinical trial to compare long-term clinical outcomes for the two treatment regimens .
CONCLUSIONS	Clinical trial registered with http://www.umin.ac.jp/english/ ( UMIN000002819 ) .

###24791643
OBJECTIVE	Insomnia patients complain that mental events keep them awake .
OBJECTIVE	This study investigates how cognitive behavioural therapy ( CBT ) affects such events and considers how attributional , cognitive and psychopathological symptoms may mediate sleep improvement .
METHODS	A pragmatic , parallel-group randomized controlled trial of 164 adults ( 120 F : ( mean 49 years ( 18-78 years ) ) meeting Diagnostic and Statistical Manual of Mental Disorders , 5th Edition ( DSM-5 ) criteria for insomnia disorder , assigned to CBT ( n = 55 ; 40 F ) , imagery relief therapy ( IRT placebo ; n = 55 ; 42 F ) , or treatment as usual ( TAU ; n = 54 ; 38 F ) , was conducted .
METHODS	CBT/IRT comprised six online sessions delivered by an animated therapist , with automated web/e-mail support .
METHODS	CBT users had access to a moderated community .
METHODS	TAU comprised ` usual care ' .
METHODS	Participants completed the Sleep Disturbance Questionnaire ( SDQ ) , Glasgow Content of Thoughts Inventory ( GCTI ) , Depression Anxiety and Stress Scales ( DASS ) and Sleep Condition Indicator ( SCI ) at baseline , post treatment and 8-week follow-up .
RESULTS	The sample was characterised by mental arousal , notably ` trying too hard ' to sleep ( SDQ ) , and by ` sleep and sleeplessness ' and ` rehearsal and planning ' thoughts ( GCTI ) .
RESULTS	Treatment effects were observed for all SDQ domains ( e.g. , CBT vs. IRT : d = 0.76 for ` trying too hard ' ) .
RESULTS	CBT was also superior to IRT on the GCTI ( e.g. , ` rehearsal and planning ' , d = 0.62 ; ` sleep and sleeplessness ' , d = 0.74 ) .
RESULTS	CBT vs. TAU comparisons yielded larger effects , whereas placebo effects ( IRT vs. TAU ) were small to moderate .
RESULTS	Hierarchical regression demonstrated partial mediation of SCI improvement by attributional and cognitive factors ( R2 = 21-27 % ) following CBT .
RESULTS	Improvement in sleep efficiency appears to be independent of such factors .
CONCLUSIONS	Online CBT modifies sleep-related attributions , night-time thought content and psychopathology .
CONCLUSIONS	This process partly mediates improvement in DSM-5-defined insomnia .

###24321171
BACKGROUND	Inadequacy in mental health care in low and middle income countries has been an important contributor to the rising global burden of disease .
BACKGROUND	The treatment gap is salient in resource-poor settings , especially when providing care for conflict-affected forced migrant populations .
BACKGROUND	Primary care is often the only available service option for the majority of forced migrants , and integration of mental health into primary care is a difficult task .
BACKGROUND	The proposed pilot study aims to explore the feasibility of integrating mental health care into primary care by providing training to primary care practitioners serving displaced populations , in order to improve identification , treatment , and referral of patients with common mental disorders via the World Health Organization Mental Health Gap Action Programme ( mhGAP ) .
METHODS	This pilot randomized controlled trial will recruit 86 primary care practitioners ( PCP ) serving in the Puttalam and Mannar districts of Sri Lanka ( with displaced and returning conflict-affected populations ) .
METHODS	The intervention arm will receive a structured training program based on the mhGAP intervention guide .
METHODS	Primary outcomes will be rates of correct identification , adequate management based on set criteria , and correct referrals of common mental disorders .
METHODS	A qualitative study exploring the attitudes , views , and perspectives of PCP on integrating mental health and primary care will be nested within the pilot study .
METHODS	An economic evaluation will be carried out by gathering service utilization information .
CONCLUSIONS	In post-conflict Sri Lanka , an important need exists to provide adequate mental health care to conflict-affected internally displaced persons who are returning to their areas of origin after prolonged displacement .
CONCLUSIONS	The proposed study will act as a local demonstration project , exploring the feasibility of formulating a larger-scale intervention study in the future , and is envisaged to provide information on engaging PCP , and data on training and evaluation including economic costs , patient recruitment , and acceptance and follow-up rates .
CONCLUSIONS	The study should provide important information on the WHO mhGAP intervention guide to add to the growing evidence base of its implementation .
BACKGROUND	SLCTR/2013/025 .

###24297090
OBJECTIVE	Anti-inflammatory glucocorticoid ( GC ) therapy often induces hyperglycemia due to insulin resistance and islet-cell dysfunction .
OBJECTIVE	Incretin-based therapies may preserve glucose tolerance and pancreatic islet-cell function .
OBJECTIVE	In this study , we hypothesized that concomitant administration of the dipeptidyl peptidase-4 inhibitor sitagliptin and prednisolone in men at high risk to develop type 2 diabetes could protect against the GC-induced diabetogenic effects .
METHODS	Men with the metabolic syndrome but without diabetes received prednisolone 30 mg once daily plus sitagliptin 100 mg once daily ( n = 14 ) , prednisolone ( n = 12 ) or sitagliptin alone ( n = 14 ) or placebo ( n = 12 ) for 14 days in a double-blind 2 2 randomized-controlled study .
METHODS	Glucose , insulin , C-peptide , and glucagon were measured in the fasted state and following a standardized mixed-meal test .
METHODS	- cell function parameters were assessed both from a hyperglycemic-arginine clamp procedure and from the meal test .
METHODS	Insulin sensitivity ( M-value ) was measured by euglycemic clamp .
RESULTS	Prednisolone increased postprandial area under the curve ( AUC ) - glucose by 17 % ( P < 0.001 vs placebo ) and postprandial AUC-glucagon by 50 % ( P < 0.001 ) .
RESULTS	Prednisolone reduced 1st and 2nd phase glucose-stimulated - and combined hyperglycemia-arginine-stimulated C-peptide secretion ( all P 0.001 ) .
RESULTS	When sitagliptin was added , both clamp-measured - cell function ( P = NS for 1st and 2nd phase vs placebo ) and postprandial hyperglucagonemia ( P = NS vs placebo ) remained unaffected .
RESULTS	However , administration of sitagliptin could not prevent prednisolone-induced increment in postprandial glucose concentrations ( P < 0.001 vs placebo ) .
RESULTS	M-value was not altered by any treatment .
CONCLUSIONS	Fourteen-day treatment with high-dose prednisolone impaired postprandial glucose metabolism in subjects with the metabolic syndrome .
CONCLUSIONS	Concomitant treatment with sitagliptin improved various aspects of pancreatic islet-cell function , but did not prevent deterioration of glucose tolerance by GC treatment .

###24606874
BACKGROUND	Fluralaner is a novel systemic insecticide and acaricide .
BACKGROUND	The purpose of these studies was to investigate the pharmacokinetic properties of fluralaner in Beagle dogs following single oral or intravenous ( i.v. ) administration .
METHODS	Following the oral administration of 12.5 , 25 or 50 mg fluralaner/kg body weight ( BW ) , formulated as chewable tablets or i.v. administration of 12.5 mg fluralaner/kg BW , formulated as i.v. solution to 24 Beagles , plasma samples were collected until 112 days after treatment .
METHODS	Plasma concentrations of fluralaner were measured using HPLC-MS/MS .
METHODS	Pharmacokinetic parameters were calculated by non-compartmental methods .
RESULTS	After oral administration , maximum plasma concentrations ( C ( max ) ) were reached within 1 day on average .
RESULTS	Fluralaner was quantifiable in plasma for up to 112 days after single oral and i.v. treatment .
RESULTS	The apparent half-life of fluralaner was 12-15 days and the mean residence time was 15-20 days .
RESULTS	The apparent volume of distribution of fluralaner was 3.1 L/kg , and clearance was 0.14 L/kg/day .
CONCLUSIONS	Fluralaner is readily absorbed after single-dose oral administration , and has a long elimination half-life , long mean residence time , relatively high apparent volume of distribution , and low clearance .
CONCLUSIONS	These pharmacokinetic characteristics help to explain the prolonged activity of fluralaner against fleas and ticks on dogs after a single oral dose .

###26118143
OBJECTIVE	To evaluate blood pressure ( BP ) control utilizing the International Society on Hypertension in Blacks ( ISHIB ) cardiovascular risk reduction toolkit in an African American community with uncontrolled hypertension .
METHODS	This is a randomized controlled pilot study conducted in two Baltimore community-based physicians ' offices assigned adults ( 18-64 years ) with uncontrolled hypertension ( systolic blood pressure [ SBP ] 169 mm Hg ; diastolic blood pressure [ DBP ] 109 mm Hg ) .
METHODS	The study compares usual care to a community-based intervention .
METHODS	In the usual care group , the patients ' BP was managed by the treating physician based on their normal office patient care protocol .
METHODS	In the intervention group , usual care was provided but , a community health worker also gave comprehensive education and assessment to the patients based on the ISHIB IMPACT cardiovascular toolkit during study initiation and follow-up visits .
METHODS	The main outcome of study was change in BP from baseline to six months .
METHODS	A secondary outcome was the proportion of patients achieving BP < 135 / < 85 mm Hg at six months .
RESULTS	Fifty-four African American patients were enrolled ; 37 completed six months of follow-up ( usual care , n = 25 ; intervention , n = 12 ) .
RESULTS	At six months the mean ( 95 % CI ) change from baseline in SBP was significantly greater in the intervention group vs the usual care group : -34.75 ( -46.55 to -22.95 ) mm Hg vs -5.65 ( -12.84 to 1.54 ) mm Hg ( P < .001 ) .
RESULTS	Mean ( 95 % CI ) change in DBP from baseline to six months was significantly greater for the intervention group vs the usual care group : -16.19 ( -24.00 to -8.39 ) mm Hg vs -4.36 ( -8.26 to -0.46 ) mm Hg ( P = .009 ) .
RESULTS	Median change in BP was significantly greater for SBP in the intervention group compared with the usual care group ( P = .007 ) , but not for DBP ( P = .197 ) .
RESULTS	The proportion of patients achieving BP < 135 / < 85 at six months was 83 % ( 10/12 ) in the intervention group vs 60 % ( 15/25 ) in the usual care group ( P = .263 ) .
CONCLUSIONS	This pilot study on the ISHIB IMPACT toolkit in managing uncontrolled hypertension in the African American community suggests better control of systolic BP and a tendency to better hypertension control with the community-based intervention .
CONCLUSIONS	The findings support further studies in clinical settings serving African American hypertensive patients to assess effectiveness of approaches for improving BP control and related outcomes .

###25604722
BACKGROUND	The impact of dairy intake on cardiometabolic risk factors associated with metabolic syndrome ( MetS ) needs further research .
OBJECTIVE	To investigate the impact of milk consumption on a wide array of cardiometabolic risk factors associated with MetS ( blood lipids , cholesterol homeostasis , glucose homeostasis , systemic inflammation , blood pressure , endothelial function ) in postmenopausal women with abdominal obesity .
METHODS	In this randomized , crossover study , 27 women with abdominal obesity consumed two 6-week diets based on the National Cholesterol Education Program ( NCEP ) , one with 3.2 servings/d of 2 % fat milk per 2000kcal ( MILK ) and one without milk or other dairy ( NCEP ) .
METHODS	The macronutrient composition of both diets was comparable ( 55 % carbohydrates , 15 % proteins , 30 % fat and 10 % saturated fat ) .
RESULTS	The MILK diet had no significant effect on LDL-C , triglycerides , LDL size , CRP and cell adhesion molecule concentrations and on indicators of insulin sensitivity .
RESULTS	The MILK diet reduced HDL-C , adiponectin , endothelin and fasting glucose levels as well blood pressure ( all P0 .01 ) , but those changes were comparable to those seen with the NCEP milk-free diet ( all between-diet P0 .07 ) .
RESULTS	Finally , the MILK diet was associated with lower VLDL apolipoprotein B fractional catabolic rate ( -13.4 % ; P = 0.04 ) and plasma sterol concentrations ( -12.0 % ; P = 0.04 ) compared with the control NCEP milk-free diet .
CONCLUSIONS	These data suggest that short-term consumption of low fat milk in the context of a prudent NCEP diet has no favorable nor deleterious effect on cardiometabolic risk factors associated with MetS in postmenopausal women with abdominal obesity .

###25224993
BACKGROUND	Disturbances of the circadian rhythm of cortisol secretion are associated with depression , coronary calcification , and higher all-cause and cardiovascular mortality.The primary aim of this study was to test the associations between midnight salivary cortisol ( MSC ) , depression and HbA1c , and control for behavioural , environmental and intra individual factors with possible impact on cortisol secretion , like smoking , physical inactivity , season , medication , diabetes duration , severe hypoglycemia episodes , age and gender in patients with type 1 diabetes .
BACKGROUND	Secondary aims were to present MSC levels for a reference group of non-depressed type 1 diabetes patients with a healthy life style ( physically active and non-smoking ) , and to explore seasonal variations .
METHODS	A cross-sectional population based study of 196 patients ( 54 % men and 46 % women ) aged 18-59 years that participated in a randomized controlled trial targeting depression in type 1 diabetes .
METHODS	Depression was assessed by the Hospital Anxiety and Depression Scale-depression subscale .
METHODS	MSC , HbA1c , serum-lipids , blood pressure , waist circumference and data from medical records and the Swedish National Diabetes Registry were collected .
RESULTS	Thirty four patients ( 17 % ) had MSC 9.3 nmol/L , which was associated with smoking ( AOR 5.5 ) , spring season ( AOR 4.3 ) , physical inactivity ( AOR 3.9 ) , self-reported depression ( AOR 3.1 ) , and older age ( per year ) ( AOR 1.08 ) .
RESULTS	HbA1c > 70 mmol/mol ( > 8.6 % ) ( AOR 4.2 ) and MSC 9.3 nmol/L ( AOR 4.4 ) were independently linked to self-reported depression .
RESULTS	Season was strongly associated with MSC levels and no other variables studied showed seasonal variations .
RESULTS	In a reference group of 137 non-depressed patients with a healthy life style ( physically active , non-smoking ) the median MSC level was 4.6 nmol/L ( range 1.9-23 .0 ) .
CONCLUSIONS	In this study of patients with type 1 diabetes high MSC was linked to smoking , physical inactivity , depression , season and older age .
CONCLUSIONS	Thus a high cortisol value identified three major targets for treatment in type 1 diabetes .

###24494287
OBJECTIVE	To compare efficacy difference among wrist-ankle needle , body-acupuncture and ibuprofen in the treatment of primary dysmenorrhea .
METHODS	Ninety-five cases were randomly divided into a wrist-ankle needle group ( 32 cases ) , a body-acupuncture group ( 31 cases ) and an ibuprofen group ( 32 cases ) .
METHODS	Acupunc - , ture at Lower 1 and Lower 2 area was applied in the wrist-ankle needle group .
METHODS	Acupuncture at Guanyuan ( CV 4 ) and Sanyinjiao ( SP 6 ) were applied in the body-acupuncture group .
METHODS	Ibuprofen sustained-release capsules were given for oral administration in the ibuprofen group .
METHODS	The treatment began 3 days before menses , once a day , until pain was relieved .
METHODS	One menstrual cycle was taken as a treatment course , continuously for 3 courses and efficacy were observed in three groups .
METHODS	The symptom score of dysmenorrhea and visual analogue scale ( VAS ) were used to assess pain severity before and after treatment .
RESULTS	1The efficacy differences in three groups were statistically significant ( P < 0.01 ) , in which the total effective rate was 90.0 % ( 27/30 ) in the wrist-ankle needle group , 73.4 % ( 22/30 ) in the body-acupuncture group and 46.7 % ( 14/30 ) in the ibuprofen group .
RESULTS	2 After the treatment , symptom score of dysmenorrhea and VAS were all obviously lower than that before the treatment in three groups ( all P < 0.01 ) .
RESULTS	Compared with ibuprofen group ( 7.12 + / -2.70 ) , after the treatment symptom score of dysmenorrhea in the wrist-ankle needle group ( 4.00 + / -3.40 ) and body-acupuncture group ( 5.53 + / -2.80 ) was obviously decreased ( P < 0.01 , P < 0.05 ) , and VAS in the wrist-ankle needle group was significantly reduced ( P < 0.05 ) .
RESULTS	Compared with body-acupuncture group ( 5.53 + / -2.80 ) , symptom score of dysmenorrhea in the wrist-ankle needle group ( 4.00 + / - 3.40 ) was obviously decreased ( P < 0.05 ) .
CONCLUSIONS	The wrist-ankle needle has better effect than body acupuncture and ibuprofen on the treatment of primary dysmenorrhea , which could significantly improve dysmenorrhea symptoms .

###25623561
OBJECTIVE	To compare the anticoagulation effect of regional citrate and heparin in patients with sustained low-efficiency hemodialysis ( SLED ) .
METHODS	This study was conducted in the teaching hospital of Sichuan University between November 2011 and January 2013.Sixty-three patients suffering from acute kidney injury or end-stage renal diseases ( ESRD ) were enrolled and further randomized to 2 groups : citrate and heparin anticoagulation treatment groups in SLED .
METHODS	SLED was conducted by Fresenius 4008sARrTplus dialyzer for 8 hours each session , and blood flow was set at 150 ml/min .
METHODS	Prothrombin time ( PT ) , activated partial thromboplastin time ( APTT ) and platelet ( PLT ) count were analyzed .
RESULTS	Sixty-three patients underwent 118 sessions of SLED .
RESULTS	Among them , 59 patients ( 93.7 % ) was discharged after treatment or converted to outpatient intermittent hemodialysis , and 4 patients died of multiple organ failure during hospitalization .
RESULTS	Compared with that in the citrate group , both PT and APTT in heparin group was significantly higher [ PT : ( 15.5 2.0 ) s vs ( 12.3 2.7 ) s , P < 0.001 ; APTT : ( 56.0 10.9 ) s vs ( 32.8 6.1 ) s , P < 0.001 ; respectively ] at 2 h during SLED.However , the PT and APTT levels in heparin group decreased afterwards and were similar with those in the citrate groups at 5 h during treatment .
RESULTS	There is no difference on PLT counts between these two groups after treatment .
CONCLUSIONS	The anticoagulation effect of regional citrate and heparin was similar in patients when receiving SLED.Regional citrate may be an alternative anticoagulant approach for the patients at high risk of bleeding who require the treatment of SLED .

###24496086
OBJECTIVE	Uncontrolled intervention studies , including studies involving breast cancer survivors , have demonstrated improvements in vasomotor symptoms ( VMS ) after stellate ganglion blockade ( SGB ) with a local anesthetic .
OBJECTIVE	This study presents the first randomized sham-controlled trial of SGB for the treatment of VMS .
METHODS	Participants included 40 postmenopausal women , aged 30 to 70 years , with moderate to severe VMS .
METHODS	The study was a randomized sham-controlled trial comparing the effects of SGB versus sham injection on the frequencies of total and moderate to severe VMS , as measured by daily diaries .
METHODS	Image-guided SGB was performed with 5 mL of 0.5 % bupivacaine .
METHODS	Sham injection of saline was performed in subcutaneous tissues in the neck .
METHODS	VMS were recorded at baseline and for 6 months thereafter .
METHODS	Objective VMS were recorded using ambulatory sternal skin conductance monitoring during a 24-hour period at baseline and on 3-month follow-up .
RESULTS	There were no significant group differences in overall VMS frequency , but the frequency of moderate to very severe VMS was reduced more in the active group compared with the sham treatment group ( event rate ratio , 0.50 ; 95 % CI , 0.35-0 .71 ; P < 0.001 ) .
RESULTS	The frequency of objective VMS was also reduced to a greater degree in the SGB group than in the sham group ( event rate ratio , 0.71 ; 95 % CI , 0.64-0 .99 ; P < 0.05 ) .
RESULTS	There were no study-related serious adverse events .
CONCLUSIONS	SGB may provide effective treatment of VMS in women who seek nonhormonal treatments because of safety concerns and personal preference .
CONCLUSIONS	The finding that SGB significantly reduces objectively measured VMS provides further evidence of efficacy .
CONCLUSIONS	A larger trial is warranted to confirm these findings .

###24705391
BACKGROUND	Long-term adaptive servoventilation ( ASV ) increases cardiac function more effectively than continuous positive airway pressure ( CPAP ) , possibly via alleviation of sympathetic overactivation .
BACKGROUND	The present study evaluated the effect of ASV and CPAP at comparable pressure on muscle sympathetic nerve activity ( MSNA ) in patients with heart failure ( HF ) and with or without periodic breathing ( PB ) .
RESULTS	A total of 57 patients with HF ( ejection fraction < 0.45 ) were randomized to receive CPAP ( n = 28 ) or ASV ( n = 29 ) .
RESULTS	Respiratory profiles and MSNA were continuously monitored before and during CPAP and ASV ( 30min ) at pressures of 6.5 and 6.6 cmH2O , respectively .
RESULTS	The severity of respiratory instability was determined using the coefficient of variation of tidal volume ( CV-TV ) .
RESULTS	Although heart rate and blood pressure remained unchanged , only ASV improved CV-TV .
RESULTS	MSNA decreased in the ASV ( P < 0.001 ) , but not in the CPAP group .
RESULTS	The change in CV-TV independently predicted changes in MSNA ( P < 0.001 ) .
RESULTS	Device type and PB significantly interacted with changes in MSNA ( P < 0.05 ) and ASV exerted sympathoinhibitory effects in patients with PB , whereas CPAP did not .
RESULTS	A sympathoinhibitory effect in patients without PB was not evident in either treatment arm .
CONCLUSIONS	ASV probably exerts its sympathoinhibitory effects in patients with HF and PB through pressure support .

###24456823
OBJECTIVE	To determine the response , toxicities , and progression free survival of a regimen of temsirolimus with or without hormonal therapy in the treatment of advanced , or recurrent endometrial carcinoma .
BACKGROUND	Preclinical evidence suggested that blockade of the PI3K/AKT/mTOR pathway might overcome resistance to hormonal therapy .
METHODS	We performed a randomized phase II trial of intravenous temsirolimus 25mg weekly versus the combination of weekly temsirolimus with a regimen of megestrol acetate 80 mg bid for three weeks alternating with tamoxifen 20mg bid for three weeks in women with recurrent or metastatic endometrial carcinoma .
RESULTS	There were 71 eligible patients who received at least one dose of therapy with 21 of these treated on the combination arm which was closed early because of an excess of venous thrombosis , with 5 episodes of deep venous thrombosis ( DVT ) and 2 pulmonary emboli .
RESULTS	There were three responses observed in that arm ( 14 % ) .
RESULTS	A total of 50 eligible patients were treated on the single agent arm with 3 episodes of DVT and 11 responses ( 22 % ) .
RESULTS	Response rates were similar in patients with prior chemotherapy ( 7 of 29 ; 24 % ) and those with no prior chemotherapy ( 4 of 21 ; 19 % ) .
RESULTS	Two of four patients with clear cell carcinoma responded .
CONCLUSIONS	Adding the combination of megestrol acetate and tamoxifen to temsirolimus therapy did not enhance activity and the combination was associated with an excess of venous thrombosis .
CONCLUSIONS	Temsirolimus activity was preserved in patients with prior adjuvant chemotherapy .

###24971004
OBJECTIVE	A link between poor sleep quality and Alzheimer 's disease ( AD ) has recently been suggested .
OBJECTIVE	Since endogenous melatonin levels are already reduced at preclinical AD stages , it is important to ask whether replenishing the missing hormone would be beneficial in AD and whether any such effects would be related to the presence of sleep disorder in patients .
METHODS	The effects of add-on prolonged-release melatonin ( PRM ) ( 2 mg ) to standard therapy on cognitive functioning and sleep were investigated in 80 patients ( men [ 50.7 % ] , women [ 49.3 % ] , average age 75.3 years [ range , 52-85 years ] ) diagnosed with mild to moderate AD , with and without insomnia comorbidity , and receiving standard therapy ( acetylcholinesterase inhibitors with or without memantine ) .
METHODS	In this randomized , double-blind , parallel-group study , patients were treated for 2 weeks with placebo and then randomized ( 1:1 ) to receive 2 mg of PRM or placebo nightly for 24 weeks , followed by 2 weeks placebo .
METHODS	The AD Assessment Scale-Cognition ( ADAS-Cog ) , Instrumental Activities of Daily Living ( IADL ) , Mini-Mental State Examination ( MMSE ) , sleep , as assessed by the Pittsburgh Sleep Quality Index ( PSQI ) and a daily sleep diary , and safety parameters were measured .
RESULTS	Patients treated with PRM ( 24 weeks ) had significantly better cognitive performance than those treated with placebo , as measured by the IADL ( P = 0.004 ) and MMSE ( P = 0.044 ) .
RESULTS	Mean ADAS-Cog did not differ between the groups .
RESULTS	Sleep efficiency , as measured by the PSQI , component 4 , was also better with PRM ( P = 0.017 ) .
RESULTS	In the comorbid insomnia ( PSQI 6 ) subgroup , PRM treatment resulted in significant and clinically meaningful effects versus the placebo , in mean IADL ( P = 0.032 ) , MMSE score ( +1.5 versus -3 points ) ( P = 0.0177 ) , and sleep efficiency ( P = 0.04 ) .
RESULTS	Median ADAS-Cog values ( -3.5 versus +3 points ) ( P = 0.045 ) were significantly better with PRM .
RESULTS	Differences were more significant at longer treatment duration .
RESULTS	PRM was well tolerated , with an adverse event profile similar to that of placebo .
CONCLUSIONS	Add-on PRM has positive effects on cognitive functioning and sleep maintenance in AD patients compared with placebo , particularly in those with insomnia comorbidity .
CONCLUSIONS	The results suggest a possible causal link between poor sleep and cognitive decline .

###26033126
BACKGROUND	ARDS is a heterogeneous syndrome that encompasses lung injury from both direct and indirect sources .
BACKGROUND	Direct ARDS ( pneumonia , aspiration ) has been hypothesized to cause more severe lung epithelial injury than indirect ARDS ( eg , nonpulmonary sepsis ) ; however , this hypothesis has not been well studied in humans .
METHODS	We measured plasma biomarkers of lung epithelial and endothelial injury and inflammation in a single-center study of 100 patients with ARDS and severe sepsis and in a secondary analysis of 853 patients with ARDS drawn from a multicenter randomized controlled trial .
METHODS	Biomarker levels in patients with direct vs indirect ARDS were compared in both cohorts .
RESULTS	In both studies , patients with direct ARDS had significantly higher levels of a biomarker of lung epithelial injury ( surfactant protein D ) and significantly lower levels of a biomarker of endothelial injury ( angiopoietin-2 ) than those with indirect ARDS .
RESULTS	These associations were robust to adjustment for severity of illness and ARDS severity .
RESULTS	In the multicenter study , patients with direct ARDS also had lower levels of von Willebrand factor antigen and IL-6 and IL-8 , markers of endothelial injury and inflammation , respectively .
RESULTS	The prognostic value of the biomarkers was similar in direct and indirect ARDS .
CONCLUSIONS	Direct lung injury in humans is characterized by a molecular phenotype consistent with more severe lung epithelial injury and less severe endothelial injury .
CONCLUSIONS	The opposite pattern was identified in indirect lung injury .
CONCLUSIONS	Clinical trials of novel therapies targeted specifically at the lung epithelium or endothelium may benefit from preferentially enrolling patients with direct and indirect ARDS , respectively .

###25046068
OBJECTIVE	This study aims to evaluate the effects of nasal packs on surgical success and related complications in septoplasty .
METHODS	Thirty-eight patients ( 21 males , 17 females ; mean age , 36.6 years , range 18 to 61 years ) were included in the study .
METHODS	Septoplasty candidates were prospectively divided into two groups .
METHODS	Nasal packing and transseptal suture technique was applied to patients in group 1 ( n = 16 ) and group 2 ( n = 22 ) , respectively .
METHODS	Postoperative pain was assessed with the visual analog scale .
METHODS	The success of surgery was questioned using the Nasal Obstruction Septoplasty Effectiveness ( NOSE ) scale .
METHODS	Surgical success was defined as a 50 % decrease in the NOSE scores .
RESULTS	There was no statistically significant difference in surgical success and complication rates between the groups ( p > 0.05 ) .
RESULTS	Pain scores were significantly higher in group 1 ( p = 0.015 ) .
CONCLUSIONS	Our study results suggest that nasal pack use does not affect surgical success and complication rates in septoplasty .
CONCLUSIONS	Pack-free septoplasty with the transseptal suture technique is an effective method in the treatment of septal deviation .

###25957978
OBJECTIVE	To compare the nasal tube with face mask as interfaces for stabilization of very preterm infants at birth by using physiological measurements of leak , obstruction , and expired tidal volumes during positive pressure ventilation ( PPV ) .
METHODS	In the delivery room , 43 infants < 30 weeks gestation were allocated to receive respiratory support by nasal tube or face mask .
METHODS	Respiratory function , heart rate , and oxygen saturation were measured .
METHODS	Occurrence of obstruction , amount of leak , and tidal volumes were compared using a Mann-Whitney U test or a Fisher exact test .
RESULTS	The first 5 minutes after initiation of PPV were analyzed ( 1566 inflations in the nasal tube group and 1896 inflations in the face mask group ) .
RESULTS	Spontaneous breathing coincided with PPV in 32 % of nasal tube and 34 % of face mask inflations .
RESULTS	During inflations , higher leak was observed using nasal tube compared with face mask ( 98 % [ 33 % -100 % ] vs 14 [ 0 % -39 % ] ; P < .0001 ) .
RESULTS	Obstruction occurred more often ( 8.2 % vs 1.1 % ; P < .0001 ) .
RESULTS	Expired tidal volumes were significantly lower during inflations when using nasal tube compared with face mask ( 0.0 [ 0.0-3 .1 ] vs 9.9 [ 5.5-12 .8 ] mL/kg ; P < .0001 ) and when spontaneous breathing coincided with PPV ( 4.4 [ 2.1-8 .4 ] vs 9.6 [ 5.4-15 .2 ] mL/kg ; P < .0001 ) but were similar during breathing on continuous positive airway pressure ( 4.7 [ 2.8-6 .9 ] vs 4.8 [ 2.7-7 .9 ] mL/kg ; P > 0.05 ) .
RESULTS	Heart rate was not significantly different between groups , but oxygen saturation was significantly lower in the nasal tube group the first 2 minutes after start of respiratory support .
CONCLUSIONS	The use of a nasal tube led to large leak , more obstruction , and inadequate tidal volumes compared with face mask .
BACKGROUND	Trial registration Registered with the Dutch Trial Registry ( NTR 2061 ) and the Australia and New Zealand Clinical Trials Register ( ACTRN 12610000230055 ) .

###24679891
OBJECTIVE	To evaluate the efficacy and safety of ospemifene , a novel selective oestrogen receptor modulator , in the treatment of vaginal dryness in postmenopausal women with vulvovaginal atrophy ( VVA ) .
METHODS	A 12 week , multicentre , randomised , double-blind , parallel-group phase III study of women ( 40-80 years ) with VVA and self-reported vaginal dryness as their most bothersome symptom .
METHODS	The co-primary efficacy endpoints were the change from baseline to Week 12 in ( 1 ) percentage of parabasal cells in the maturation index ( MI ) , ( 2 ) percentage of superficial cells in the MI , ( 3 ) vaginal pH , and ( 4 ) severity of vaginal dryness .
METHODS	Safety assessments included physical examination , cervical Papanicolaou test and clinical laboratory analyses .
METHODS	Endometrial thickness and histology was also assessed .
RESULTS	A total of 314 women were randomised to once-daily ospemifene 60 mg/day ( n = 160 ) or placebo ( n = 154 ) .
RESULTS	Significant improvements in the percentages of parabasal and superficial cells in the MI and vaginal pH were observed with ospemifene compared with placebo ( p < 0.001 for all parameters ) .
RESULTS	The mean change from baseline in severity score of vaginal dryness reported by women receiving ospemifene compared with those receiving placebo approached statistical significance ( p = 0.080 ) .
RESULTS	Improvements in each of the four co-primary endpoints with ospemifene were statistically significant compared to placebo in the per protocol population .
RESULTS	The majority of treatment-emergent adverse events were considered mild to moderate in severity .
CONCLUSIONS	Once-daily oral ospemifene 60 mg was effective for the treatment of VVA in postmenopausal women with vaginal dryness .

###24828266
BACKGROUND	Guidelines recommend lopinavir/ritonavir ( LPV/r ) as first - and second-line therapy for young and older HIV-infected children , respectively .
BACKGROUND	Available formulations have limitations making their widespread use complex .
METHODS	An open-label comparative bioavailability ( randomized crossover ) study compared a novel twice-daily minitab sprinkle formulation ( 40 mg/10 mg , Cipla Pharmaceuticals ) versus innovator syrup in HIV-infected Ugandan infants aged 3 to < 12 months ( cohort A ) and children aged 1-4 years ( cohort B ) and versus Cipla tablets ( 100/25 mg ) in children aged 4 to < 13 years ( cohort C ) .
METHODS	Twelve-hour intensive pharmacokinetic sampling after observed LPV/r intake ( plus 2 nucleoside reverse transcriptase inhibitors ) following World Health Organization 2010 dosing with food was performed 4 weeks after enrollment .
METHODS	Children then switched formulation ; sampling was repeated at week 8 .
METHODS	Acceptability data were also collected .
RESULTS	Seventy-seven infants/children were included in cohort A ( n = 19 ) / B ( n = 26 ) / C ( n = 32 ) .
RESULTS	Among 132 evaluable pharmacokinetic profiles , there were 13/21/25 within-child comparisons in cohort A/B/C .
RESULTS	For minitabs versus syrup , geometric mean [ 95 % confidence interval ( CI ) ] AUC0-12h was 88.6 ( 66.7-117 .6 ) versus 77.6 ( 49.5-121 .5 ) hmg/L in cohort A [ geometric mean ratio ( GMR ) ( 90 % CI ) = 1.14 ( 0.71 to 1.85 ) ] and 138.7 ( 118.2 to 162.6 ) versus 109.1 ( 93.7 to 127.1 ) hmg/L in cohort B [ GMR ( 90 % CI ) = 1.27 ( 1.10 to 1.46 ) ] .
RESULTS	For minitabs versus tablets , geometric mean ( 95 % CI ) AUC0-12h was 83.1 ( 66.7 to 103.5 ) versus 115.6 ( 103.0 to 129.7 ) hmg/L ; GMR ( 90 % CI ) = 0.72 ( 0.60 to 0.86 ) .
RESULTS	Subtherapeutic levels ( < 1.0 mg/L ) occurred in 0 ( 0 % ) / 2 ( 15 % ) minitabs/syrup in infants ( P = 0.48 ) , no children aged 1-4 years and 4 ( 16 % ) / 1 ( 4 % ) minitabs/tablets ( P = 0.35 ) .
RESULTS	About 13/17 ( 76 % ) and 19/26 ( 73 % ) caregivers of infants and children aged 1-4 years , respectively , chose to continue minitabs after week 8 , mainly for convenience ; only 7/29 ( 24 % ) older children ( five < 6 years ) remained on minitabs .
CONCLUSIONS	LPV/r exposure from minitabs was comparable with syrup , but lower than tablets , with no significant differences in subtherapeutic concentrations .
CONCLUSIONS	Minitabs were more acceptable than syrups for younger children , but older children preferred tablets .

###26241597
OBJECTIVE	Mindfulness-based interventions may be acceptable to veterans who have poor adherence to existing evidence-based treatments for posttraumatic stress disorder ( PTSD ) .
OBJECTIVE	To compare mindfulness-based stress reduction with present-centered group therapy for treatment of PTSD .
METHODS	Randomized clinical trial of 116 veterans with PTSD recruited at the Minneapolis Veterans Affairs Medical Center from March 2012 to December 2013 .
METHODS	Outcomes were assessed before , during , and after treatment and at 2-month follow-up .
METHODS	Data collection was completed on April 22 , 2014 .
METHODS	Participants were randomly assigned to receive mindfulness-based stress reduction therapy ( n = 58 ) , consisting of 9 sessions ( 8 weekly 2.5-hour group sessions and a daylong retreat ) focused on teaching patients to attend to the present moment in a nonjudgmental , accepting manner ; or present-centered group therapy ( n = 58 ) , an active-control condition consisting of 9 weekly 1.5-hour group sessions focused on current life problems .
METHODS	The primary outcome , change in PTSD symptom severity over time , was assessed using the PTSD Checklist ( range , 17-85 ; higher scores indicate greater severity ; reduction of 10 or more considered a minimal clinically important difference ) at baseline and weeks 3 , 6 , 9 , and 17 .
METHODS	Secondary outcomes included PTSD diagnosis and symptom severity assessed by independent evaluators using the Clinician-Administered PTSD Scale along with improvements in depressive symptoms , quality of life , and mindfulness .
RESULTS	Participants in the mindfulness-based stress reduction group demonstrated greater improvement in self-reported PTSD symptom severity during treatment ( change in mean PTSD Checklist scores from 63.6 to 55.7 vs 58.8 to 55.8 with present-centered group therapy ; between-group difference , 4.95 ; 95 % CI , 1.92-7 .99 ; P = .002 ) and at 2-month follow-up ( change in mean scores from 63.6 to 54.4 vs 58.8 to 56.0 , respectively ; difference , 6.44 ; 95 % CI , 3.34-9 .53 , P < .001 ) .
RESULTS	Although participants in the mindfulness-based stress reduction group were more likely to show clinically significant improvement in self-reported PTSD symptom severity ( 48.9 % vs 28.1 % with present-centered group therapy ; difference , 20.9 % ; 95 % CI , 2.2 % -39.5 % ; P = .03 ) at 2-month follow-up , they were no more likely to have loss of PTSD diagnosis ( 53.3 % vs 47.3 % , respectively ; difference , 6.0 % ; 95 % CI , -14.1 % to 26.2 % ; P = .55 ) .
CONCLUSIONS	Among veterans with PTSD , mindfulness-based stress reduction therapy , compared with present-centered group therapy , resulted in a greater decrease in PTSD symptom severity .
CONCLUSIONS	However , the magnitude of the average improvement suggests a modest effect .
BACKGROUND	clinicaltrials.gov Identifier : NCT01548742 .

###25486674
BACKGROUND	The relationship between tobacco and cannabis use is strong .
BACKGROUND	When co-smokers try to quit only one substance , this relationship often leads to a substitution effect , that is , the increased use of the remaining substance .
BACKGROUND	Stopping the use of both substances simultaneously is therefore a reasonable strategy , but co-smokers rarely report feeling ready for simultaneous cessation .
BACKGROUND	Thus , the question of how co-smokers can be motivated to attempt a simultaneous cessation has arisen .
BACKGROUND	To reach as many co-smokers as possible , we developed brief Web-based interventions aimed at enhancing the readiness to simultaneously quit tobacco and cannabis use .
OBJECTIVE	Our aim was to analyze the efficacy of three different Web-based interventions designed to enhance co-smokers ' readiness to stop tobacco and cannabis use simultaneously .
METHODS	Within a randomized trial , three brief Web-based and fully automated interventions were compared .
METHODS	The first intervention combined the assessment of cigarette dependence and problematic cannabis use with personalized , normative feedback .
METHODS	The second intervention was based on principles of motivational interviewing .
METHODS	As an active psychoeducational control group , the third intervention merely provided information on tobacco , cannabis , and the co-use of the two substances .
METHODS	The readiness to quit tobacco and cannabis simultaneously was measured before and after the intervention ( both online ) and 8 weeks later ( online or over the phone ) .
METHODS	Secondary outcomes included the frequency of cigarette and cannabis use , as measured at baseline and after 8 weeks .
RESULTS	A total of 2467 website users were assessed for eligibility based on their self-reported tobacco and cannabis co-use , and 325 participants were ultimately randomized and analyzed .
RESULTS	For the post-intervention assessment , generalized estimating equations revealed a significant increase in the readiness to quit tobacco and cannabis in the total sample ( B = .33 , 95 % CI 0.10-0 .56 , P = .006 ) .
RESULTS	However , this effect was not significant for the comparison between baseline and the 8-week follow-up assessment ( P = .69 ) .
RESULTS	Furthermore , no differential effects between the interventions were found , nor were any significant intervention or time effects found on the frequency of tobacco or cannabis use .
CONCLUSIONS	In the new field of dual interventions for co-smokers of tobacco and cannabis , Web-based interventions can increase the short-term readiness to quit tobacco and cannabis simultaneously .
CONCLUSIONS	The studied personalized techniques were no more effective than was psychoeducation .
CONCLUSIONS	The analyzed brief interventions did not change the secondary outcomes , that is the frequency of tobacco and cannabis use .
BACKGROUND	International Standard Randomized Controlled Trial Number ( ISRCTN ) : 56326375 ; http://www.isrctn.com/ISRCTN56326375 ( Archived by WebCite at http://www.webcitation.org/6UUWBh8u0 ) .

###24520674
OBJECTIVE	To evaluate the clinical effects of Yuleshu oral mixture combined with conventional therapy on chronic prostatitis .
METHODS	Eighty-eight patients with chronic prostatitis/chronic pelvic pain syndrome ( CP/CPPS ) were equally randomized to a control and an experimental group to receive conventional therapy ( oral antibiotics , alpha blockers , proprietary Chinese medicine for activating blood circulation and massage of the prostate ) and conventional therapy combined with Yuleshu oral mixture respectively .
METHODS	Before and after treatment , the severity of symptoms and sexual function of the patients were evaluated using NIH-CPSI and IIEF-5 , their anxiety , depression and other emotional problems assessed with Hamilton Depression Rating Scale ( HAMD ) and Hamilton Anxiety Scale ( HAMA ) , and the results subjected to statistical analysis .
RESULTS	Both the experimental and control groups showed significant improvement in prostatitis symptoms and sexual function after treatment as compared with the baseline ( P < 0.01 ) , even more significant in the former than in the latter group , especially in pain symptoms ( 7.89 + / - 2.82 vs 10.41 + / - 2.55 , P < 0.01 ) .
RESULTS	Before and after treatment , the HAMA and HAMD score had no significant difference in the control , but there was significant difference in the experimental group .
RESULTS	The experimental group exhibited remarkably higher scores after than before treatment on HAMA ( 24.30 + / - 5.07 vs 13.80 + / - 3.62 , P < 0.01 ) and HAMD ( 23.81 + / - 5.01 vs 16.23 + / - 5.93 , P < 0.01 ) , but not the control group ( P > 0.05 ) .
CONCLUSIONS	Yuleshu oral mixture can effectively relieve anxiety , depression and other psychological problems in CP/CPPS patients , and improve their clinical symptoms as well .
CONCLUSIONS	Therefore , it is an effective drug for chronic prostatitis .

###25302624
OBJECTIVE	To investigate clinical efficacy and safety of 2 certolizumab pegol ( CZP ) maintenance dosing regimens plus methotrexate ( MTX ) in active rheumatoid arthritis ( RA ) patients achieving the American College of Rheumatology 20 % improvement criteria ( ACR20 ) after the CZP 200 mg every 2 weeks open-label run-in period .
METHODS	DOSEFLEX ( dosing flexibility ) was a double-blind , placebo-controlled randomized study with an open-label run-in phase .
METHODS	During the run-in phase , all patients received CZP 400 mg ( weeks 0 , 2 , and 4 ) and 200 mg every 2 weeks to week 16 .
METHODS	Week 16 ACR20 responders were randomized 1:1:1 at week 18 to CZP 200 mg every 2 weeks , 400 mg every 4 weeks , or placebo .
RESULTS	A total of 209 ( of 333 ) patients were randomized at week 18 ( CZP : 200 mg , n = 70 ; 400 mg , n = 70 ; placebo , n = 69 ) .
RESULTS	Groups had similar baseline characteristics ( week 0 ) .
RESULTS	Week 34 ACR20 response rates were comparable between the CZP 200 mg every 2 weeks and the 400 mg every 4 weeks groups ( 67.1 % versus 65.2 % ) , which was significantly higher than placebo ( 44.9 % ; P = 0.009 and P = 0.017 ) .
RESULTS	ACR50/70 and remission criteria were met more frequently in CZP groups than placebo at week 34 , with similar responses between anti-tumor necrosis factor-experienced and naive patients .
RESULTS	Improvements from baseline Disease Activity Score in 28 joints using the erythrocyte sedimentation rate and Health Assessment Questionnaire disability index scores were maintained in CZP groups from week 16 to 34 while worsening on placebo .
RESULTS	Adverse event ( AE ) rates in the double-blind phase were 62.9 % versus 60.9 % versus 62.3 % ; serious AE rates were 7.1 % versus 2.9 % versus 0.0 % ( CZP 200 mg , 400 mg , and placebo groups ) .
CONCLUSIONS	In active RA patients with an incomplete MTX response , CZP 200 mg every 2 weeks and 400 mg every 4 weeks were comparable and better than placebo for maintaining clinical response to week 4 following a 16-week , open-label run-in phase .

###24534400
OBJECTIVE	The goal of this study was to evaluate the effectiveness of nebulized beclomethasone in preventing the recurrence of viral wheezing .
METHODS	The study was designed as a randomized , double-blind , placebo-controlled trial .
METHODS	Outpatient children aged 1 to 5 years with at least 1 episode of viral wheezing in the last 12 months , presenting to any of 40 Italian pediatricians for an upper respiratory tract infection , were randomly allocated to receive beclomethasone 400 g or placebo twice daily for 10 days .
METHODS	Medications were administered through a nebulizer .
METHODS	A clinical evaluation was performed by the pediatrician at the start and end of the treatment period .
METHODS	A subjective evaluation of symptoms and efficacy of treatment was performed by the parents .
METHODS	The primary endpoint was the incidence of viral wheezing diagnosed by the pediatricians during the 10-day treatment period .
RESULTS	A total of 525 children were enrolled in the study , 521 of whom were visited at the end of the treatment period .
RESULTS	Wheezing was diagnosed by the pediatricians in 47 children ( 9.0 % [ 95 % confidence interval : 6.7 to 11.3 ] ) , with no statistically significant differences between treatment groups ( beclomethasone versus placebo relative risk : 0.61 [ 95 % confidence interval : 0.35 to 1.08 ] ) .
RESULTS	The treatment was considered helpful by 63 % of parents ( 64 % in the beclomethasone group vs 61 % in the placebo group ) .
RESULTS	In all , 46 % of children still had infection symptoms at the end of the treatment period , with no differences between groups .
CONCLUSIONS	The findings from this study confirm that inhaled steroids are not effective in preventing recurrence of viral wheezing .
CONCLUSIONS	Moreover , no benefits were found in reducing symptoms of respiratory tract infections .

###24231555
OBJECTIVE	To examine the effect of repeated-sprint training ( RST ) vs combined RST and resistance training with superimposed vibrations on repeated-sprint ability ( RSA ) and lower-body power output in male rugby players .
METHODS	Players were divided into 2 training groups .
METHODS	One group performed RST ( n = 10 ) 2 d/wk and the other performed RST 1 d/wk and squat resistance training with superimposed vibrations on the second day ( RS+ST ; n = 10 ) .
METHODS	The squat training was carried out with a volume similar ( ie , number of sets and repetitions ) to that of the RST .
METHODS	The training period lasted 6 wk , and it was carried out as a supplement to the regular rugby training sessions .
RESULTS	Substantial improvements in RSA mean time ( RSA ( mean ) ; +2.3 % / ES : 0.77 vs +4.1 % / ES : 0.91 ) , RSA percent decrement ( % Dec ; -25.6 % / ES : 1.70 vs -23.2 % / ES : 0.99 ) , and squat absolute power output ( +5.0 % / ES :0.36 vs +17.2 % / ES : 0.93 ) were obtained in RST and RS+ST , respectively .
RESULTS	Substantial improvements in RSA best time ( RSA ( best ) ; +2.6 % / ES : 0.61 ) and squat power output normalized to body mass ( +18.6 % / ES : 0.76 ) only occurred in RS+ST .
RESULTS	Both pretest and posttest RSA ( mean ) were largely correlated with the RSA ( best ) .
RESULTS	However , there were only unclear , small to moderate correlations between individual changes in squat power output and either RSA ( mean ) or RSA ( best ) .
CONCLUSIONS	Combined RST and resistance training induced improvements of greater magnitude in both repeated-sprint performance and muscle power output than the RST alone .
CONCLUSIONS	The lack of substantial correlations between individual changes in repeated-sprint and muscle-power performance suggests that the same subjects were not systematically low or high responders to both RST and strength training .

###24886444
BACKGROUND	The relative performance of ART sealant and fluoride-releasing resin sealant in preventing fissure caries in permanent molars was compared in a randomized clinical trial conducted in southern China ( ClinicalTrials.gov NCT01829334 ) .
METHODS	After obtaining ethical approval , healthy schoolchildren who had permanent first molars with occlusal fissures which were sound but deep or presented with only incipient caries were recruited for the study .
METHODS	Included molars were randomly allocated into one of four parallel study groups in units of left/right teeth per mouth .
METHODS	Two of the four groups adopted the methods of ART or fluoride-releasing resin sealant placement while the other two groups adopted the topical fluoride application methods .
METHODS	Fissure status of the molars in each group was evaluated every 6 months .
METHODS	Development of dentine caries and sealant retention over 24 months in the molars in the two sealant-using groups was compared in this report .
METHODS	Outcome on cost-effectiveness of all four groups over 36 months will be reported elsewhere .
RESULTS	At baseline , a total of 280 children ( 383 molars ) with mean age 7.8 years were involved for the two sealant groups .
RESULTS	After 24 months , 261 children ( 357 molars ) were followed .
RESULTS	Proportions of molars with dentine caries were 7.3 % and 3.9 % in the ART sealant and fluoride-releasing resin sealant groups , respectively ( chi-square test , p = 0.171 ) .
RESULTS	Life-table survival analysis showed that sealant retention ( full and partial ) rate over 24 months for the resin sealant ( 73 % ) was significantly higher than that ( 50 % ) for the ART sealant ( p < 0.001 ) .
RESULTS	Molar survival ( no development of dentine caries ) rates in the ART sealant ( 93 % ) and fluoride-releasing resin sealant ( 96 % ) groups were not significantly different ( p = 0.169 ) .
RESULTS	Multilevel logistic regression ( GEE modeling ) accounting for the effects of data clustering and confounding factors confirmed this finding .
CONCLUSIONS	Though the retention of fluoride-releasing resin sealant was better than that of the ART sealant , their effectiveness in preventing fissure caries in permanent molars did not differ significantly over 24 months .
CONCLUSIONS	ART sealants could be a good alternative when and where resources for resin sealant placement are not readily available .

###25873064
BACKGROUND	Introduction of calcineurin inhibitors had led to improved survival rates in liver transplant recipients .
BACKGROUND	However , long-term use of calcineurin inhibitors is associated with a higher risk of chronic renal failure , neurotoxicity , de novo malignancies , recurrence of hepatitis C viral ( HCV ) infection and hepatocellular carcinoma .
BACKGROUND	Several studies have shown that everolimus has the potential to provide protection against viral replication , malignancy , and progression of fibrosis , as well as preventing nephrotoxicity by facilitating calcineurin inhibitor reduction without compromising efficacy .
BACKGROUND	The Hephaistos study evaluates the beneficial effects of early initiation of everolimus in de novo liver transplant recipients .
METHODS	Hephaistos is an ongoing 12-month , multi-center , open-label , controlled study aiming to enroll 330 de novo liver transplant recipients from 15 centers across Germany .
METHODS	Patients are randomized in a 1:1 ratio ( 7-21days post-transplantation ) to receive everolimus ( trough levels 3-8ng / mL ) with reduced tacrolimus ( trough levels < 5ng/mL ) , or standard tacrolimus ( trough levels 6-10ng / mL ) after entering a run-in period ( 3-5days post-transplantation ) .
METHODS	In the run-in period , patients are treated with induction therapy , mycophenolate mofetil , tacrolimus , and corticosteroids according to local practice .
METHODS	Randomization is stratified by HCV status and model of end-stage liver disease scores at transplantation .
METHODS	The primary objective of the study is to exhibit superior renal function ( estimated glomerular filtration rate assessed by the Modification of Diet in Renal Disease ( MDRD ) -4 formula ) with everolimus plus reduced tacrolimus compared to standard tacrolimus at Month 12 .
METHODS	Other objectives are : to assess the incidence of treated biopsy-proven acute rejection , graft loss , or death ; the incidences of components of the composite efficacy endpoint ; renal function via estimated glomerular filtration rate using various formulae ( MDRD-4 , Nankivell , Cockcroft-Gault , chronic kidney disease epidemiology collaboration and Hoek formulae ) ; the incidence of proteinuria ; the incidence of adverse events and serious adverse events ; the incidence and severity of cytomegalovirus and HCV infections and HCV-related fibrosis .
CONCLUSIONS	This study aims to demonstrate superior renal function , comparable efficacy , and safety in de novo liver transplant recipients receiving everolimus with reduced tacrolimus compared with standard tacrolimus .
CONCLUSIONS	This study also evaluates the antiviral benefit by early initiation of everolimus .
BACKGROUND	NCT01551212 .

###25007675
OBJECTIVE	To compare the hemostatic effects of local packing of Nasopore combined with hemocoagulase injection and local packing of Nasopore combined with saline injection for postoperative management of functional endoscopic sinus surgery by a double-blind , randomized control clinical trial .
METHODS	Sixty-eight cases of chronic sinusitis needed functional endoscopic sinus surgery were randomly divided into the experimental group of 40 cases and control group of 28 cases , respectively .
METHODS	For the experimental group , 1 U of hemocoagulase dissolved in 0.5 ml saline was injected into Nasopore which was packed into the nasal cavity after operation .
METHODS	For the control group , 0.5 ml of saline was injected .
METHODS	The postoperative bleeding of the two groups were scored by visual analogue scale .
RESULTS	There was statistically significant difference between the bleeding VAS scores assessed 6 hours and the ones assessed 1 , 2 and 3 days after the operation in the control group ( P < 0.05 ) .
RESULTS	There was the statistically significant difference between the bleeding VAS scores of experimental group and control group assessed 6 h after the operation ( P < 0.05 ) .
CONCLUSIONS	The hemocoagulase may improve the hemostatic effect of Nasopore 6 hours after the operation by combined injection with Nasopore as nasal cavity packing .

###24410993
BACKGROUND	To follow up on a recent report from our lab [ Hum Psychopharmacol 25:359 -367 , 2010 . ]
BACKGROUND	we examined the effects of caffeine on salivary - amylase ( sAA ) activity in response to an engaging , non-stressful task in healthy young males ( age 18-30 yrs ) who consumed caffeine on a daily basis .
BACKGROUND	Using a placebo-controlled , double-blind , between-subjects design , 45 men received either placebo , 200 mg or 400 mg of caffeine ( Vivarin ) .
BACKGROUND	Participants then rested for 20 minutes , and performed a 20-minute computerized air traffic controller-like task that was cognitively engaging but not stressful .
BACKGROUND	Saliva samples ( assayed for sAA and cortisol ) , blood pressure , and heart rate were taken before ( baseline ) and 15 minutes after the computerized task .
RESULTS	Systolic and diastolic blood pressure and sAA activity increased across the laboratory session ( F 's > 9.20 , p 's < 0.05 ) ; salivary cortisol levels decreased ( F = 16.17 , p < 0.05 ) .
RESULTS	There were no main effects for caffeine administration on sAA , salivary cortisol , or cardiovascular measures , and caffeine did not interact with the task to alter these measures .
CONCLUSIONS	Laboratory administered caffeine does not alter sAA activity , even when sAA activity is stimulated by participating in a cognitively engaging task .
CONCLUSIONS	These data demonstrate that caffeine administration does not affect sAA activity , at least in healthy young men who regularly consume caffeine .
CONCLUSIONS	Results support recent findings that basal caffeine levels in habitual caffeine users are not associated with basal sAA activity and that daily caffeine intake and diurnal sAA activity are not related .

###25828637
BACKGROUND	The present randomized , two-period , cross-over bioequivalence study compared two soft capsules of etoposide ( test and reference formulations ) , in treating 18 advanced lung cancer patients .
METHODS	The pharmacokinetic parameters were determined based on the concentrations of etoposide , using HPLC with fluorescence detector .
METHODS	In each of the two study periods , a single dose of test or reference product was administered .
METHODS	The pharmacokinetic parameters assessed included area under the plasma concentration-time curve ( AUC ( 0-12h ) ) from 0 to 12 hours , AUC ( 0-T ) from time zero to infinity , the peak plasma concentration of the drug ( C ( max ) ) , time to achieve C ( max ) , and the elimination half-life .
RESULTS	Comparison of the test and reference products containing etoposide showed that geometric mean ratios ( 90 % confidence interval ( CI ) ) of AUC ( 0-T ) , AUC ( 0 - ) , and C ( max ) were 99.7 % ( 92.1 - 103.7 % ) , 99.4 % ( 92.3 - 105.2 % ) , and 101.5 % ( 94.2 - 109.6 % ) , respectively .
RESULTS	Both AUC and C ( max ) ratio 90 % CI of test and reference formulations were within its acceptable range for bioequivalence .
RESULTS	The values of tmax and t1/2 were not found to have a statistically significant difference between the test and the reference drug ( p > 0.05 ) .
RESULTS	No adverse events occurred in this bioequivalence study .
CONCLUSIONS	The two etoposide soft capsules ( the test and reference formulations ) were bioequivalent .

###25998572
OBJECTIVE	Low-dose acetylsalicylic acid ( ASA ; aspirin ) for secondary prevention reduces cardiovascular disease mortality risk .
OBJECTIVE	ASA acetylates cyclooxygenase in the portal circulation and is rapidly ( half-life , 20 min ) hydrolyzed .
OBJECTIVE	Certain patients with cardiovascular disease may exhibit high on-therapy platelet reactivity as a result of high platelet turnover , a process whereby platelets are produced and are active beyond the duration of antiplatelet coverage provided by once-daily immediate-release ( IR ) ASA .
OBJECTIVE	A once-daily , extended-release ( ER ) ASA formulation using ER microcapsule technology was developed to release ASA over the 24-h dosing interval and reduce maximal plasma concentrations to spare peripheral endogenous endothelial prostacyclin production .
METHODS	Healthy adults ( n = 50 ) were randomized in a crossover study to receive two different ER-ASA single doses ( up to 325 mg ) and two different IR-ASA single doses ( up to 81 mg ) in four periods , each separated by 14 days .
METHODS	Pharmacodynamics was assessed by measuring serum thromboxane B2 ( TXB2 ) , urine 11-dehydro-TXB2 , and arachidonic acid-induced platelet aggregation .
METHODS	Pharmacokinetics was determined for ASA and salicylic acid ( SA ) .
RESULTS	Both formulations produced dose-dependent inhibition on all pharmacodynamic parameters .
RESULTS	Marked inhibition of TXB2 and 11-dehydro-TXB2 was maintained over the 24-h dosing interval after a dose of 81 mg ER-ASA or 40 mg IR-ASA .
RESULTS	The dose required to achieve 50 % of maximum TXB2 inhibition with ER-ASA was 49.9 mg versus 29.6 mg for IR-ASA , for a similar maximum pharmacodynamic effect ( 98.9 % TXB2 inhibition ) .
RESULTS	This suggests that an approximately twofold greater ER-ASA dose ( 162.5 mg ) is necessary to obtain the same response as that of IR-ASA 81 mg .
RESULTS	Peak ASA concentrations were lower and Tmax was longer with ER-ASA versus IR-ASA .
RESULTS	Administration of IR-ASA resulted in a dose-normalized mean Cmax of ASA that was approximately sixfold higher than that for ER-ASA and a Cmax of SA approximately two - to threefold higher than that for ER-ASA .
CONCLUSIONS	Both ASA formulations showed dose-dependent antiplatelet activity .
CONCLUSIONS	Compared with the IR-ASA , ER-ASA released active drug more slowly , resulting in prolonged absorption and lower systemic drug concentrations , which is expected for an ER ( 24-h ) formulation .

###25693331
BACKGROUND	In our hospital , lumbar epidural analgesia had been used for postoperative analgesia following vaginal total hysterectomy ( VTH ) .
BACKGROUND	But some patients experienced severe abdominal pain or numbness of the legs .
BACKGROUND	Therefore we planned a randomized prospective study to compare lower thoracic epidural analgesia and lumbar epidural analgesia following VTH .
METHODS	Fifty patients were allocated to two groups : those who received lower thoracic epidural analgesia ( T group ) and the other who received lumbar epidural analgesia ( L group ) .
METHODS	Both groupsreceived the same continuous epidural analgesia using fentanyl and ropivacaine after the operation .
RESULTS	The T group required significantly lower frequency of analgesic agents compared with that of the L group ( 2.51.9 times vs. 1.21.1 times , P < 0.05 ) .
RESULTS	Fewer patients in the T group had felt numbness in their legs compared to the L group ( 8 % vs. 55 % , P < 0.05 ) .
CONCLUSIONS	Lower thoracic epidural analgesia is more effective to provide postoperative analgesic effect following VTH compared with lumbar epidural analgesia .

###24763478
OBJECTIVE	To evaluate changes in corneal epithelial and stromal thickness after corneal collagen cross-linking ( CXL ) in eyes with keratoconus and postoperative corneal ectasia using spectral-domain optical coherence tomography ( SD-OCT ) .
METHODS	Anterior segment SD-OCT ( RTVue-100 ; Optovue , Inc. , Fremont , CA ) was used to compare regional corneal epithelial and stromal thickness in eyes with keratoconus and ectasia before CXL and 1 and 3 months after CXL .
METHODS	The anterior surface of the cornea , epithelium-Bowman 's layer interface , and posterior reflective surface were used as anatomical landmarks to measure epithelial and stromal thickness , respectively .
METHODS	Regional thickness was assessed centrally and at 21 points 0.5 mm apart across the central 6 mm of the corneal vertex in the horizontal and vertical meridians .
RESULTS	Thirty-one eyes from 30 patients were evaluated , including 17 eyes ( 17 patients ) with keratoconus and 14 eyes ( 13 patients ) with ectasia .
RESULTS	Preoperatively , a highly irregular epithelial thickness profile and distribution was observed in both groups .
RESULTS	After CXL , epithelial thickness was significantly thinner 2.5 and 2 mm below and 1.5 mm above the corneal apex ( 49.26 5.69 m ; range : 43 to 62 m ) , and 2.5 and 1 mm nasal and 2 mm temporal to the corneal apex ( 46.66 4.53 m ; range : 39 to 57 m ) compared to preoperative values ( P < .05 for all measurements ) .
RESULTS	Epithelial thickness standard deviations were significantly lower ( by 3 to 6 m ) 3 months after CXL , compared to ranges before CXL in both the vertical and horizontal meridians for keratoconus and ectasia ( P = .048 ) .
RESULTS	No significant differences were found between epithelial remodeling in keratoconus and corneal ectasia ( P = .98 ) .
RESULTS	No significant or consistent stromal changes were found for either group .
CONCLUSIONS	Significant epithelial remodeling occurs after CXL in eyes with keratoconus and corneal ectasia , creating a similar , more regularized thickness profile in all meridians in the early postoperative period .
CONCLUSIONS	This pattern of remodeling may facilitate interpretation of corneal curvature and thickness changes after CXL and may be related to visual acuity after CXL .

###24398143
BACKGROUND	Second-generation everolimus-eluting stents ( EES ) and third generation biolimus-eluting stents ( BES ) have been shown to be superior to first-generation paclitaxel-eluting stents ( PES ) and second-generation sirolimus-eluting stents ( SES ) .
BACKGROUND	However , neointimal proliferation and very late stent thrombosis is still an unresolved issue of drug-eluting stent ( DES ) implantation overall .
BACKGROUND	The Absorb ( Abbott Vascular , Abbott Park , IL , USA ) is the first CE approved DES with a bioresorbable vascular scaffold ( BVS ) thought to reduce long-term complication rates .
BACKGROUND	The EVERBIO II trial was set up to compare the BVS safety and efficacy with both EES and BES in all patients viable for inclusion .
METHODS	The EVERBIO II trial is a single-center , assessor-blinded , randomized trial .
METHODS	The study population consists of all patients aged18 years old undergoing percutaneous coronary intervention .
METHODS	Exclusion criterion is where the lesion can not be treated with BVS ( reference vessel diameter > 4.0 mm ) .
METHODS	A total of 240 patients will be enrolled and randomly assigned into 3 groups of 80 with either BVS , EES or BES implantation .
METHODS	All patients will undergo a follow-up angiography study at 9 months .
METHODS	Clinical follow-up for up to 5 years will be conducted by telephone .
METHODS	The primary endpoint is in-segment late lumen loss at 9 months measured by quantitative coronary angiography .
METHODS	Secondary endpoints are patient-oriented major adverse cardiac event ( MACE ) ( death , myocardial infarction and target-vessel revascularization ) , device-oriented MACE ( cardiac death , myocardial infarction and target-lesion revascularization ) , stent thrombosis according to ARC and binary restenosis at follow-up 12 months angiography .
CONCLUSIONS	EVERBIO II is an independent , randomized study , aiming to compare the clinical efficacy , angiographic outcomes and safety of BVS , EES and BES in all comer patients .
BACKGROUND	The trial listed in clinicaltrials.gov as NCT01711931 .

###24699466
BACKGROUND	To provide broader protection against pneumococcal disease , new vaccines containing conserved Streptococcus pneumoniae proteins are being developed .
BACKGROUND	This study assessed the safety , reactogenicity and immunogenicity of four formulations containing pneumococcal proteins pneumolysin toxoid ( dPly ) and histidine triad protein ( PhtD ) in toddlers .
METHODS	In this phase II , multicenter , observer-blind study ( www.clinicaltrials.gov : NCT00985751 ) conducted in the Czech Republic , toddlers ( 12-23 months ) were randomized ( 1:1:1:1:1 ) to receive one of four investigational vaccine formulations ( 10 or 30g each of dPly and PhtD , alone or in combination with polysaccharide conjugates from the pneumococcal non-typeable Haemophilus influenzae protein-D conjugate vaccine [ PHiD-CV ] ) , or the licensed PHiD-CV , in a 2-dose primary series plus booster at study months 0 , 2 and 6 .
METHODS	Solicited local and general symptoms were recorded within seven days post-vaccination , unsolicited symptoms within 31 days post-vaccination , and serious adverse events ( SAEs ) during the entire study period .
METHODS	Antibody concentrations against the vaccine components were measured pre-vaccination , one month post-dose 2 , pre - and one month post-booster .
RESULTS	257 toddlers were enrolled and vaccinated .
RESULTS	Percentages of solicited local and general symptoms following the different investigational formulations were generally within the same ranges as for PHiD-CV .
RESULTS	After each dose , grade 3 fever ( > 40.0 C , rectal measurement ) was reported for maximum one toddler in each group with no differences between investigational formulations and PHiD-CV during primary vaccination .
RESULTS	23 SAEs were reported for 17 toddlers , with distribution balanced between all groups except the group receiving 30 g dPly/PhtD with PHiD-CV-conjugates ( no SAEs reported ) .
RESULTS	None of the SAEs were considered to be vaccine-related .
RESULTS	For all pneumococcal protein-containing formulations , anti-PhtD and anti-Ply antibody geometric mean concentrations increased from pre-vaccination to post-dose 2 and from pre - to post-booster vaccination .
CONCLUSIONS	All investigational vaccine formulations were well-tolerated and immunogenic when administered to toddlers as a 2-dose primary vaccination followed by a booster dose .

###24366100
BACKGROUND	The purpose of this study was to evaluate a personalized protocol with diluted contrast material ( CM ) for coronary computed tomography angiography ( CTA ) .
RESULTS	One hundred patients with suspected coronary artery disease underwent retrospective electrocardiogram-gated coronary CTA on a 256-slice multidetector-row CT scanner .
RESULTS	In the diluted CM protocol ( n = 50 ) , the optimal scan timing and CM dilution rate were determined by the timing bolus scan , with 20 % CM dilution ( 5ml/s during 10s ) being considered suitable to achieve the target arterial attenuation of 350 Hounsfield units ( HU ) .
RESULTS	In the body weight ( BW ) - adjusted protocol ( n = 50 , 222mg iodine/kg ) , only the optimal scan timing was determined by the timing bolus scan .
RESULTS	The injection rate and volume in the timing bolus scan and real scan were identical between the 2 protocols .
RESULTS	We compared the means and variations in coronary attenuation between the 2 protocols .
RESULTS	Coronary attenuation ( meanSD ) in the diluted CM and BW-adjusted protocols was 346.123.9 HU and 298.845.2 HU , respectively .
RESULTS	The diluted CM protocol provided significantly higher coronary attenuation and lower variance than did the BW-adjusted protocol ( P < 0.05 , in each ) .
CONCLUSIONS	The diluted CM protocol facilitates more uniform attenuation on coronary CTA in comparison with the BW-adjusted protocol .

###25315893
BACKGROUND	Technological innovations in dental materials have been fueled by the desire of patients to improve the esthetics of their teeth .
BACKGROUND	This emphasis on esthetics has led dentists to seek resources that respect the standards established by society , but without compromising the integrity of the teeth .
METHODS	The aim of the proposed controlled clinical trial will be to assess colorimetric changes and increased dental sensitivity in adolescent patients submitted to tooth whitening with 6 % and 7.5 % hydrogen peroxide using home kits with whitening strips .
METHODS	Adolescents aged 12 to 20 years will be allocated to different groups based on treatment ( n = 16 per group ) : ( 1 ) placebo ; ( 2 ) 6.0 % hydrogen peroxide ( White Class with Calcium , FGM ) ; ( 3 ) 7.5 % hydrogen peroxide ( White Class with Calcium , FGM ) ; and ( 4 ) 7.5 % hydrogen peroxide ( Oral B 3D White , Oral-B ) .
METHODS	After the whitening procedures , the participants will be evaluated using a visual analog scale for tooth sensitivity and digital spectrophotometry to measure changes in color .
METHODS	Descriptive analysis of the data will be performed .
METHODS	Either the chi-squared test or Fisher 's exact test will be used for the determination of associations among the categorical variables .
METHODS	Student 's t-test and analysis of variance will be used to compare mean colorimetric data .
METHODS	Pearson 's correlation coefficients will be calculated to determine the strength of correlations among the continuous variables .
CONCLUSIONS	This randomized trial will provide an opportunity to evaluate products such as whitening strips in comparison to other self-administered methods , especially in adolescents .
BACKGROUND	The protocol for this study was submitted to Clinical Trials in November 2013 with registration number NCT01998386 .

###25141360
BACKGROUND	Hypertension treatments include sodium restriction , pharmacological management , and lifestyle modifications .
BACKGROUND	Although many cases of hypertension can be controlled by medication , individuals may experience side effects or incur out-of-pocket expenses , and some may not comply with the treatment regimen .
BACKGROUND	Although some previous studies have shown a favorable effect for qigong on hypertension , well-designed , rigorous trials evaluating the effect of qigong on hypertension are scarce .
OBJECTIVE	This study aimed to evaluate the effect of qigong on prehypertension and mild hypertension and to calculate a sample size for a subsequent randomized , clinical trial ( RCT ) .
METHODS	Participants were randomized to a qigong group or an untreated control group .
METHODS	This study was conducted at the Oriental Medical Center of Dongeui University , in the Republic of Korea .
METHODS	Participants were individuals between the ages of 19 and 65 y with systolic blood pressure ( SBP ) between 120 and 159 mm Hg and/or diastolic blood pressure ( DBP ) between 80 and 99 mm Hg .
METHODS	The qigong group attended qigong classes 3 / wk and performed qigong at home at least 2 / wk .
METHODS	Participants in the control group did not receive any intervention for hypertension .
METHODS	Outcome measures for this study were ( 1 ) changes in blood pressure ( BP ) ; ( 2 ) quality of life ( QOL ) using 2 surveys : the Medical Outcomes Study ( MOS ) 36-item short form ( SF-36 ) ( Korean version ) and the Measure Yourself Medical Outcome Profile 2 ( MYMOP2 ) ; and ( 3 ) hormone levels .
RESULTS	Of 40 participants , 19 were randomly assigned to the qigong group , and 21 were assigned to the control group .
RESULTS	After 8 wk , significant differences were observed between the qigong and the control groups regarding changes in SBP ( P = .0064 ) and DBP ( P = .0003 ) .
RESULTS	Among the categories of the MYMOP2 questionnaire , only wellbeing was significantly different between the 2 groups ( P = .0322 ) .
RESULTS	The qigong group showed a significantly greater improvement in the physical component score of the SF-36 compared with the control group ( P = .0373 ) .
RESULTS	Regarding changes in hormone levels , there was no significant difference between the qigong and the control groups .
RESULTS	This pilot study demonstrates that regarding sample size , a RCT evaluating the effect of qigong on hypertension should include 22 participants based on DBP and 285 participants based on SBP in each group , thus allowing for a loss to follow-up rate of 20 % .
CONCLUSIONS	The results indicate that qigong may be an effective intervention in reducing BP in prehypertension and mild hypertension .
CONCLUSIONS	Further studies should include an appropriate sample size and methodology to determine the mechanism of qigong on BP .

###24666029
OBJECTIVE	The metabolic variability and response to acute systematic hypoxia have been characterized by the high resolution of liquid chromatography/time-of-flight/mass spectrometry ( LC-TOF/MS ) in this study .
OBJECTIVE	Specifically , we compared the urinary metabolic profiles of six healthy sedentary men under normoxia ( 21 % O2 ) with acute systematic hypoxic conditions of 12 % ( equivalent to about 4500 m in altitude ) and 15 % O2 ( equivalent to about 3000 m in altitude ) for 2 h in a normobaric hypoxia chamber .
RESULTS	A clear separation of dose-dependent responses was visualized by Partial Least Squares Discriminant Analysis ( PLS-DA ) between normoxic and hypoxic conditions .
RESULTS	Over one thousand features were found in this study , about 10 % of which showed significant change from hypoxia treatment and 26 metabolites were identified ; however , there is great variability in metabolite concentrations among the 6 subjects , which reflects the diversity of human systems .
RESULTS	Within the variability , we found that 1-methyladenosine and 5-methylthioadenosine are conspicuously upregulated ; on the other hand , 3-inodoleacetic acid and L-glutamic acid were downregulated .
CONCLUSIONS	The increase in purine metabolic products ( uric acid , xanthine , and hypoxathine ) results from hypoxia ; this increase can be used as a marker for the hypoxic condition .
CONCLUSIONS	1-Methyladenosine was also highly upregulated from MH to SH and may be a very sensitive biomarker that reflects cellular hypoxia , due to its potential connection to HIF-1 .
CONCLUSIONS	The increase of free carnitine and acetyl carnitines , on the other hand , signals a change in the pathway of energy , or lipid , metabolism .

###25047162
OBJECTIVE	There is still no gold standard technique for graft fixation during anterior cruciate ligament reconstruction .
OBJECTIVE	We compared the functional outcomes of patients receiving either ToggleLoc with ZipLoop technology or Translig transverse crosspin device for femoral graft fixation .
METHODS	A total of 118 patients were randomly allocated into two groups to receive either Translig ( ) transverse crosspin ( Translig group 1 : n = 51 , mean age 28.347.83 years , age 18-40years ) or ToggleLoc with ZipLoop technology ( ToggleLoc group : n = 67 , mean age 26.858.76 , age 16-41years ) for femoral graft fixation .
METHODS	Early and 1-year assessment was made with Lysholm knee scale , International Knee Documentation Committee Scoring , Tegner Activity Level Scale , KT-1000 arthrometer and pivot shift test .
RESULTS	Preoperative vs. postoperative functional parameters showed significant improvement in both groups .
RESULTS	Two groups were similar in terms of Lysholm knee scale , IKDC and Tegner activity scores ( p > 0.05 ) .
RESULTS	The KT-1000 arthrometer revealed slightly less anterior sliding in Translig group than that in ToggleLoc group ( p > 0.05 ) .
RESULTS	ToggleLoc technique allowed a radiographically more horizontal placement of the graft than Translig technique .
CONCLUSIONS	Two distinct techniques used in this study are likely to be suitable for femoral graft fixation during anterior cruciate ligament reconstruction with the femoral tunnel being created via anteromedial approach .

###25606785
BACKGROUND	Antibody-mediated rejection ( AMR ) is a severe form of rejection , mediated primarily by antibody-dependent complement ( C ) activation .
BACKGROUND	C1 inhibitor ( C1-INH , Berinert ) inhibits the classical and lectin pathways of C activation .
BACKGROUND	We performed a randomized , placebo-controlled study using C1-INH in highly sensitized renal transplant recipients for prevention of AMR .
METHODS	Twenty highly sensitized patients desensitized with IVIG + rituximabplasma exchange were enrolled and randomized 1:1 to receive plasma-derived human C1-INH ( 20 IU/kg/dose ) versus placebo intraoperatively , then twice weekly for 7 doses .
METHODS	Renal function , adverse events ( AEs ) / serious AEs , C3 , C4 , and C1-INH levels were monitored and C1q + HLA antibodies were also blindly assessed .
RESULTS	One patient in the C1-INH group versus 2 patients in the placebo group developed serious AEs , but none were related to study drug .
RESULTS	Delayed graft function developed in 1 C1-INH subject and 4 in the placebo .
RESULTS	The C1-INH trough levels increased with C1-INH treatment .
RESULTS	C3 and C4 levels also increased significantly in the C1-INH group compared to placebo .
RESULTS	No C1-INH patient developed AMR during the study .
RESULTS	Two patients developed AMR after the study .
RESULTS	Three placebo patients developed AMR , one during the study .
RESULTS	C1q + donor specific antibodies were reduced in 2 C1-INH treated patients tested , while immunoglobulin G DSA levels showed decreased binding for both groups .
CONCLUSIONS	The C1-INH appears safe in the posttransplant period .
CONCLUSIONS	The C1-INH treatment may reduce ischemia-reperfusion injury .
CONCLUSIONS	The C1-INH also resulted in significant elevations of C1-INH levels , C3 , C4 , and reduced C1q + HLA antibodies .
CONCLUSIONS	Taken together , the combination of antibody reduction and C1-INH may prove useful in prevention of AMR .
CONCLUSIONS	Further controlled studies are warranted .

###24794367
OBJECTIVE	Invasive candidiasis in premature infants causes death and neurodevelopmental impairment .
OBJECTIVE	Fluconazole prophylaxis reduces candidiasis , but its effect on mortality and the safety of fluconazole are unknown .
OBJECTIVE	To evaluate the efficacy and safety of fluconazole in preventing death or invasive candidiasis in extremely low-birth-weight infants .
METHODS	This study was a randomized , blinded , placebo-controlled trial of fluconazole in premature infants .
METHODS	Infants weighing less than 750 g at birth ( N = 361 ) from 32 neonatal intensive care units ( NICUs ) in the United States were randomly assigned to receive either fluconazole or placebo twice weekly for 42 days .
METHODS	Surviving infants were evaluated at 18 to 22 months corrected age for neurodevelopmental outcomes .
METHODS	The study was conducted between November 2008 and February 2013 .
METHODS	Fluconazole ( 6 mg/kg of body weight ) or placebo .
METHODS	The primary end point was a composite of death or definite or probable invasive candidiasis prior to study day 49 ( 1 week after completion of study drug ) .
METHODS	Secondary and safety outcomes included invasive candidiasis , liver function , bacterial infection , length of stay , intracranial hemorrhage , periventricular leukomalacia , chronic lung disease , patent ductus arteriosus requiring surgery , retinopathy of prematurity requiring surgery , necrotizing enterocolitis , spontaneous intestinal perforation , and neurodevelopmental outcomes-defined as a Bayley-III cognition composite score of less than 70 , blindness , deafness , or cerebral palsy at 18 to 22 months corrected age .
RESULTS	Among infants receiving fluconazole , the composite primary end point of death or invasive candidiasis was 16 % ( 95 % CI , 11 % -22 % ) vs 21 % in the placebo group ( 95 % CI , 15 % -28 % ; odds ratio , 0.73 [ 95 % CI , 0.43-1 .23 ] ; P = .24 ; treatment difference , -5 % [ 95 % CI , -13 % to 3 % ] ) .
RESULTS	Invasive candidiasis occurred less frequently in the fluconazole group ( 3 % [ 95 % CI , 1 % -6 % ] ) vs the placebo group ( 9 % [ 95 % CI , 5 % -14 % ] ; P = .02 ; treatment difference , -6 % [ 95 % CI , -11 % to -1 % ] ) .
RESULTS	The cumulative incidences of other secondary outcomes were not statistically different between groups .
RESULTS	Neurodevelopmental impairment did not differ between the groups ( fluconazole , 31 % [ 95 % CI , 21 % -41 % ] vs placebo , 27 % [ 95 % CI , 18 % -37 % ] ; P = .60 ; treatment difference , 4 % [ 95 % CI , -10 % to 17 % ] ) .
CONCLUSIONS	Among infants with a birth weight of less than 750 g , 42 days of fluconazole prophylaxis compared with placebo did not result in a lower incidence of the composite of death or invasive candidiasis .
CONCLUSIONS	These findings do not support the universal use of prophylactic fluconazole in extremely low-birth-weight infants .
BACKGROUND	clinicaltrials.gov Identifier : NCT00734539 .

###24836273
BACKGROUND	Bone metastases frequently cause skeletal events in patients with metastatic castration-resistant prostate cancer .
BACKGROUND	Radium-223 dichloride ( radium-223 ) selectively targets bone metastases with high-energy , short-range - particles .
BACKGROUND	We assessed the effect of radium-223 compared with placebo in patients with castration-resistant prostate cancer and bone metastases .
METHODS	In this phase 3 , double-blind , randomised ALSYMPCA trial , we enrolled patients who had symptomatic castration-resistant prostate cancer with two or more bone metastases and no known visceral metastases , who were receiving best standard of care , and had previously either received or were unsuitable for docetaxel .
METHODS	Patients were stratified by previous docetaxel use , baseline total alkaline phosphatase level , and current bisphosphonate use , then randomly assigned ( 2:1 ) to receive either six intravenous injections of radium-223 ( 50 kBq/kg ) or matching placebo ; one injection was given every 4 weeks .
METHODS	Randomisation was done with an interactive voice response system , taking into account trial stratification factors .
METHODS	Participants and investigators were masked to treatment assignment .
METHODS	The primary endpoint was overall survival , which has been reported previously .
METHODS	Here we report on time to first symptomatic skeletal event , defined as the use of external beam radiation to relieve bone pain , or occurrence of a new symptomatic pathological fracture ( vertebral or non-verterbal ) , or occurence of spinal cord compression , or tumour-related orthopeadic surgical intervention .
METHODS	All events were required to be clinically apparent and were not assessed by periodic radiological review .
METHODS	Statistical analyses of symptomatic skeletal events were based on the intention-to-treat population .
METHODS	The study has been completed and is registered with ClinicalTrials.gov , number NCT00699751 .
RESULTS	Between June 12 , 2008 , and Feb 1 , 2011 , 921 patients were enrolled , of whom 614 ( 67 % ) were randomly assigned to receive radium-223 and 307 ( 33 % ) placebo .
RESULTS	Symptomatic skeletal events occurred in 202 ( 33 % ) of 614 patients in the radium-223 group and 116 ( 38 % ) of 307 patients in the placebo group .
RESULTS	Time to first symptomatic skeletal event was longer with radium-223 than with placebo ( median 156 months [ 95 % CI 135-180 ] vs 98 months [ 73-237 ] ; hazard ratio [ HR ] = 066 , 95 % CI 052-083 ; p = 000037 ) .
RESULTS	The risks of external beam radiation therapy for bone pain ( HR 067 , 95 % CI 053-085 ) and spinal cord compression ( HR = 052 , 95 % CI 029-093 ) were reduced with radium-233 compared with placebo .
RESULTS	Radium-223 treatment did not seem to significantly reduce the risk of symptomatic pathological bone fracture ( HR 062 , 95 % CI 035-109 ) , or the need for tumour-related orthopaedic surgical intervention ( HR 072 , 95 % CI 028-182 ) .
CONCLUSIONS	Radium-223 should be considered as a treatment option for patients with castration-resistant prostate cancer and symptomatic bone metastases .
BACKGROUND	Algeta and Bayer HealthCare Pharmaceuticals .

###24798675
OBJECTIVE	Discontinuation of bisphosphonate therapy after 3 to 5 years is increasingly considered , but methods to monitor fracture risk after discontinuation have not been established .
OBJECTIVE	To test methods of predicting fracture risk among women who have discontinued alendronate therapy after 4 to 5 years .
METHODS	The prospective Fracture Intervention Trial Long-term Extension ( FLEX ) study randomized postmenopausal women aged 61 to 86 years previously treated with 4 to 5 years of alendronate therapy to 5 more years of alendronate or placebo from 1998 through 2003 ; the present analysis includes only the placebo group .
METHODS	Hip and spine dual-energy x-ray absorptiometry ( DXA ) were measured when placebo was begun ( FLEX baseline ) and after 1 to 3 years of follow-up .
METHODS	Two biochemical markers of bone turnover , urinary type 1 collagen cross-linked N-telopeptide ( NTX ) and serum bone-specific alkaline phosphatase ( BAP ) , were measured at FLEX baseline and after 1 and 3 years .
METHODS	Symptomatic spine and nonspine fractures occurring after the follow-up measurement of DXA or bone turnover .
RESULTS	During 5 years of placebo , 94 of 437 women ( 22 % ) experienced 1 or more symptomatic fractures ; 82 had fractures after 1 year .
RESULTS	One-year changes in hip DXA , NTX , and BAP were not related to subsequent fracture risk , but older age and lower hip DXA at time of discontinuation were significantly related to increased fracture risk ( lowest tertile of baseline femoral neck DXA vs other 2 tertiles relative hazard ratio , 2.17 [ 95 % CI , 1.38-3 .41 ] ; total hip DXA relative hazard ratio , 1.87 [ 95 % CI , 1.20-2 .92 ] ) .
CONCLUSIONS	Among postmenopausal women who discontinue alendronate therapy after 4 to 5 years , age and hip BMD at discontinuation predict clinical fractures during the subsequent 5 years .
CONCLUSIONS	Follow-up measurements of DXA 1 year after discontinuation and of BAP or NTX 1 to 2 years after discontinuation are not associated with fracture risk and can not be recommended .
BACKGROUND	clinicaltrials.gov Identifier : NCT00398931 .

###24450500
BACKGROUND	Decreased ability of muscles to respond to anabolic stimuli is part of the underlying mechanism for muscle loss with aging .
BACKGROUND	Previous studies suggest that substantial amounts of essential amino acids ( EAA ) , whey protein and leucine are beneficial for stimulation of acute muscle protein synthesis in older adults .
BACKGROUND	However , these studies supplied only proteins , and no bolus studies have been done with dairy products or supplements that contained also fat and carbohydrates besides proteins .
BACKGROUND	The aim of this study was to evaluate whether a specifically designed nutritional supplement in older adults stimulates muscle protein synthesis acutely to a greater extent than a conventional dairy product .
BACKGROUND	Moreover , the combined effect with resistance exercise was studied by using a unilateral resistance exercise protocol .
METHODS	Utilizing a randomized , controlled , double blind study design , healthy older adults received a single bolus of a high whey protein , leucine-enriched supplement ( EXP : 20 g whey protein , 3g total leucine , 150 kcal ; n = 9 ) or an iso-caloric milk protein control (
METHODS	6g milk protein ; n = 10 ) , immediately after unilateral resistance exercise .
METHODS	Postprandial mixed muscle protein fractional synthesis rate ( FSR ) was measured over 4h using a tracer infusion protocol with L - [ ring-C ] - phenylalanine and regular blood and muscle sampling .
RESULTS	FSR was significantly higher overall after EXP ( 0.07800.0070 % / h ) vs CONTROL ( 0.05740.0066 % / h ( EMMSE ) ) ( p = 0.049 ) .
RESULTS	No interaction between treatment and exercise was observed ( p = 0.519 ) .
RESULTS	Higher postprandial concentrations of EAA and leucine are possible mediating factors for the FSR response , while plasma insulin increase did not dictate the FSR response .
RESULTS	Moreover , when the protein intake from the supplements was expressed per kg leg lean mass ( LLM ) , a significant correlation was observed with resting postprandial FSR ( r = 0.48 , P = 0.038 ) .
CONCLUSIONS	Ingestion of a high whey protein , leucine-enriched supplement resulted in a larger overall postprandial muscle protein synthesis rate in healthy older subjects compared with a conventional dairy product .
CONCLUSIONS	This acute effect is promising for long-term effects on parameters of muscle mass , strength and function in sarcopenic older people , which requires further study .
BACKGROUND	This trial is registered in the Dutch Trial Register under number NTR1823 .

###25313450
OBJECTIVE	To determine the effectiveness of a pedometer-based telephone lifestyle coaching intervention on weight and physical activity .
METHODS	A randomized controlled trial was conducted with 313 patients referred to cardiac rehabilitation in rural and urban Australia .
METHODS	Participants were allocated to a healthy weight ( HW ) ( 4 telephone coaching sessions on weight and physical activity ) or a physical activity ( PA ) intervention ( 2 telephone coaching sessions on physical activity ) .
METHODS	Weight and physical activity were assessed by self-report at baseline , short-term ( 6-8 weeks ) , and medium-term ( 6-8 months ) .
RESULTS	More than 90 % of participants completed the trial .
RESULTS	Over the medium-term , participants in the HW group decreased their weight compared with participants in the PA group ( P = .005 ) .
RESULTS	Participants in the HW group with a body mass index of 25 kg/m had a mean weight loss of 1.6 kg compared with participants in the PA-only group who lost a mean of 0.4 kg ( P = .015 ) .
RESULTS	Short-term , both groups increased their physical activity time , and the PA group maintained this increase at the medium-term .
CONCLUSIONS	Participants in the HW group achieved modest improvements in weight , and those in the PA group demonstrated increased physical activity .
CONCLUSIONS	Low-contact , telephone-based interventions are a feasible means of delivering lifestyle interventions for underserved rural communities , for those not attending cardiac rehabilitation , or as an adjunct to cardiac rehabilitation .

###24618282
OBJECTIVE	To compare the kinematics of lower limb joints between individuals with and without chronic ankle instability ( CAI ) during cross-turn and - cutting movements .
METHODS	Cross-sectional study .
METHODS	Motion analysis laboratory .
METHODS	Twelve subjects with CAI and twelve healthy controls .
METHODS	Hip flexion , adduction , and internal rotation , knee flexion , and ankle dorsiflexion and inversion angles were calculated in the 200ms before initial ground contact and from initial ground contact to toe-off ( stance phase ) in a cross-turn movement during gait and a cross-cutting movement from a forward jump , and compared across the two groups .
RESULTS	In the cross-cutting movement , the CAI group exhibited greater hip and knee flexion than the control group during the stance phase , and more hip abduction during the period before initial contact and the stance phase .
RESULTS	In the cross-turn movement the joint kinematics were similar in the two groups .
CONCLUSIONS	CAI subjects exhibited an altered pattern of the proximal joint kinematics during a cross-cutting movement .
CONCLUSIONS	It is important for clinicians to assess the function of the hip and knee as well as the ankle , and to incorporate coordination training for the entire lower limb into rehabilitation after lateral ankle sprains .

###24885076
BACKGROUND	It is thought that therapy should be functional , be highly repetitive , and promote afferent input to best stimulate hand motor recovery after stroke , yet patients struggle to access such therapy .
BACKGROUND	We developed the MusicGlove , an instrumented glove that requires the user to practice gripping-like movements and thumb-finger opposition to play a highly engaging , music-based , video game .
BACKGROUND	The purpose of this study was to 1 ) compare the effect of training with MusicGlove to conventional hand therapy 2 ) determine if MusicGlove training was more effective than a matched form of isometric hand movement training ; and 3 ) determine if MusicGlove game scores predict clinical outcomes .
METHODS	12 chronic stroke survivors with moderate hemiparesis were randomly assigned to receive MusicGlove , isometric , and conventional hand therapy in a within-subjects design .
METHODS	Each subject participated in six one-hour treatment sessions three times per week for two weeks , for each training type , for a total of 18 treatment sessions .
METHODS	A blinded rater assessed hand impairment before and after each training type and at one-month follow-up including the Box and Blocks ( B & B ) test as the primary outcome measure .
METHODS	Subjects also completed the Intrinsic Motivation Inventory ( IMI ) .
RESULTS	Subjects improved hand function related to grasping small objects more after MusicGlove compared to conventional training , as measured by the B & B score ( improvement of 3.213.82 vs. -0.292.27 blocks ; P = 0.010 ) and the 9 Hole Peg test ( improvement of 2.142.98 vs. -0.851.29 pegs/minute ; P = 0.005 ) .
RESULTS	There was no significant difference between training types in the broader assessment batteries of hand function .
RESULTS	Subjects benefited less from isometric therapy than MusicGlove training , but the difference was not significant ( P > 0.09 ) .
RESULTS	Subjects sustained improvements in hand function at a one month follow-up , and found the MusicGlove more motivating than the other two therapies , as measured by the IMI .
RESULTS	MusicGlove games scores correlated strongly with the B & B score .
CONCLUSIONS	These results support the hypothesis that hand therapy that is engaging , incorporates high numbers of repetitions of gripping and thumb-finger opposition movements , and promotes afferent input is a promising approach to improving an individual 's ability to manipulate small objects .
CONCLUSIONS	The MusicGlove provides a simple way to access such therapy .

###24937510
OBJECTIVE	Current US healthcare delivery systems do not adequately address healthcare demands .
OBJECTIVE	Physicians are integral but rarely emphasize prevention as a primary tool to change health outcomes .
OBJECTIVE	Home visitation is an effective method for changing health outcomes in some populations .
OBJECTIVE	The Florida International University Herbert Wertheim College of Medicine Green Family Foundation NeighborhoodHELP service-learning program assigns medical students to be members of interprofessional teams that conduct household visits to determine their healthcare needs .
METHODS	We performed a prospective evaluation of 330 households randomly assigned to one of two groups : visitation from a student team ( intervention group ) or limited intervention ( control group ) .
METHODS	The program design allowed randomly selected control households to replace intervention-group households that left the program of their own volition .
METHODS	All of the households were surveyed at baseline and after 1 year of participation in the study .
RESULTS	After 1 year in the program and after adjustment for confounders , intervention group households proved more likely ( P 0.05 ) than control households to have undergone physical examinations , blood pressure monitoring , and cervical cytology screenings .
RESULTS	Cholesterol screenings and mammograms were borderline significant ( P = 0.05 and P = 0.06 , respectively ) .
CONCLUSIONS	This study supports the value of home visitation by interprofessional student teams as an effective way to increase the use of preventive health measures .
CONCLUSIONS	The study underscores the important role interprofessional student teams may play in improving the health of US communities , while students concurrently learn about primary prevention and primary care .

###24956862
OBJECTIVE	To observe the effect of detoxifying and blood circulation activating Chinese herb extraction of polygonum cuspidatum and hawthorn on carotid intima-media thickness ( IMT ) , plaque integral and plaque stability related serum indexes of patients with carotid atherosclerosis .
METHODS	Sixty and four cases of carotid artery atherosclerosis patients were assigned randomly to 2 groups : detoxifying and blood circulation activating treatment group ( treatment group , 32 cases ) and control group ( 32 cases ) .
METHODS	Patients in treatment group were treated with capsules of extraction of polygonum cuspidatum and hawthorn , 1 pill po , bid ( dosage of administration : polygonum cuspidatum extraction 5.33 mg x kg ( -1 ) x d ( -1 ) , hawthorn extraction 5.0 mg x kg ( -1 ) x d ( -1 ) ) ; patients in control group were treated with lovastatin 20 mg po , qd ( dosage of administration : 0.33 mg x kg ( -1 ) x d ( -1 ) ) .
METHODS	The course of treatment was six months .
METHODS	To observe changes of IMT , plaque integral , and detect the level of plaque stability related serum indexes such as Hs-CRP , MMP-1 and TIMP-1 .
RESULTS	After 6 months of treatment , in control group one patient quit the clinical trial because of liver dysfunction and one patient was rejected because of having not followed the therapeutic regimen .
RESULTS	32 cases in treatment group and 30 cases in control group were analyzed .
RESULTS	The results showed that IMT and plaque integral of treatment group decreased significantly after the treatment ( P < 0.05 , P < 0.01 ) , and there was no significant difference compared with control grope .
RESULTS	Serum Hs-CRP , MMP-1 and MMP-1 / TIMP-1 decreased after the treatment ( P < 0.05 , P < 0.01 ) , and the treatment group was superior to control group in decreasing serum Hs-CRP ( P < 0.05 ) .
CONCLUSIONS	Detoxifying and blood circulation activating Chinese herb extraction of polygonum cuspidatum and hawthorn has good effect of anti-atherosclerosis and promoting plaque stability .
CONCLUSIONS	Its mechanism might be related with anti-inflammation and inhibiting degradation of extracellular matrix , and deserves further studies .

###25681312
BACKGROUND	Hip fractures are a leading cause of mortality and disability worldwide , and the number of hip fractures is expected to rise to over 6 million per year by 2050 .
BACKGROUND	The optimal approach for the surgical management of displaced femoral neck fractures remains unknown .
BACKGROUND	Current evidence suggests the use of arthroplasty ; however , there is lack of evidence regarding whether patients with displaced femoral neck fractures experience better outcomes with total hip arthroplasty ( THA ) or hemiarthroplasty ( HA ) .
BACKGROUND	The HEALTH trial compares outcomes following THA versus HA in patients 50years of age or older with displaced femoral neck fractures .
METHODS	HEALTH is a multicentre , randomised controlled trial where 1434 patients , 50years of age or older , with displaced femoral neck fractures from international sites are randomised to receive either THA or HA .
METHODS	Exclusion criteria include associated major injuries of the lower extremity , hip infection ( s ) and a history of frank dementia .
METHODS	The primary outcome is unplanned secondary procedures and the secondary outcomes include functional outcomes , patient quality of life , mortality and hip-related complications-both within 2years of the initial surgery .
METHODS	We are using minimisation to ensure balance between intervention groups for the following factors : age , prefracture living , prefracture functional status , American Society for Anesthesiologists ( ASA ) Class and centre number .
METHODS	Data analysts and the HEALTH Steering Committee are blinded to the surgical allocation throughout the trial .
METHODS	Outcome analysis will be performed using a ( 2 ) test ( or Fisher 's exact test ) and Cox proportional hazards modelling estimate .
METHODS	All results will be presented with 95 % CIs .
BACKGROUND	The HEALTH trial has received local and McMaster University Research Ethics Board ( REB ) approval ( REB # : 06-151 ) .
RESULTS	Outcomes from the primary manuscript will be disseminated through publications in academic journals and presentations at relevant orthopaedic conferences .
RESULTS	We will communicate trial results to all participating sites .
RESULTS	Participating sites will communicate results with patients who have indicated an interest in knowing the results .
BACKGROUND	The HEALTH trial is registered with clinicaltrials.gov ( NCT00556842 ) .

###26054136
OBJECTIVE	To observe the difference in the analgesic effect on primary dysmenorrheal between acupuncture and sham acupuncture at Sanyinjiao ( SP 6 ) during menstrual pain and evaluate the impact of psychological effect on acupuncture analgesia .
METHODS	Sixty subjects were randomized into an acupuncture group and a sham acupuncture group , 30 cases in each one .
METHODS	The conventional acupuncture and sham acupuncture were applied to Sanyinjiao ( SP 6 ) on bilateral sides when menstrual pain began to attack and needles were retained for 30 min each time .
METHODS	Three menstrual cycles were required .
METHODS	The visual analogue scale ( VAS ) was adopted to determine the scores before and 0.5 h , 1 h , 3 h , 6 h and 12 h after acupuncture during menstrual pain in each cycle separately .
RESULTS	In the acupuncture group , VAS score at each time point after acupuncture was reduced as compared with that at the previous one during menstrual pain in each menstrual cycle , indicating the significant difference ( all P < 0.05 ) .
RESULTS	In the sham acupuncture group , the scores in 6 h and 12 h of acupuncture were reduced as compared with the previous one , indicating the significant difference ( all P < 0.05 ) .
RESULTS	After acupuncture , VAS score at each time point in the acupuncture group was lower than that in the sham acupuncture group ( all P < 0.05 ) .
CONCLUSIONS	The conventional acupuncture at Sanyinjiao ( SP 6 ) achieves the significant analgesic effect on primary dysmenorrheal .
CONCLUSIONS	The psychological placebo effect of sham acupuncture has no obvious impact on acupuncture analgesia .

###24440678
OBJECTIVE	The first multicenter randomized controlled trial was designed and conducted to assess the safety and effectiveness of totally percutaneous endovascular aortic aneurysm repair ( PEVAR ) with use of a 21F endovascular stent graft system and either an 8 F or 10 F suture-mediated closure system ( the PEVAR trial , NCT01070069 ) .
OBJECTIVE	A noninferiority trial design was chosen to compare percutaneous access with standard open femoral exposure .
METHODS	Between 2010 and 2012 , 20 U.S. institutions participated in a prospective , Food and Drug Administration-approved randomized trial to evaluate percutaneous femoral artery access and closure by a `` preclose '' technique in conjunction with endovascular abdominal aortic aneurysm repair .
METHODS	A total of 151 patients were allocated by a 2:1 design to percutaneous access/closure ( n = 101 ) or open femoral exposure ( n = 50 [ FE ] ) .
METHODS	PEVAR procedures were performed with either the 8 F Perclose ProGlide ( n = 50 [ PG ] ) or the 10 F Prostar XL ( n = 51 [ PS ] ) closure devices .
METHODS	All endovascular abdominal aortic aneurysm repair procedures were performed with the Endologix 21 F profile ( outer diameter ) sheath-based system .
METHODS	Patients were screened by computed tomography with three-dimensional reconstruction and independent physician review for anatomic suitability and adequate femoral artery anatomy for percutaneous access .
METHODS	The primary trial end point ( treatment success ) was defined as procedural technical success and absence of major adverse events and vascular complications at 30 days .
METHODS	An independent access closure substudy evaluated major access-related complications .
METHODS	Clinical utility and procedural outcomes , ankle-brachial index , blood laboratory analyses , and quality of life were also evaluated with continuing follow-up to 6 months .
RESULTS	Baseline characteristics were similar among groups .
RESULTS	Procedural technical success was 94 % ( PG ) , 88 % ( PS ) , and 98 % ( FE ) .
RESULTS	One-month primary treatment success was 88 % ( PG ) , 78 % ( PS ) , and 78 % ( FE ) , demonstrating noninferiority vs FE for PG ( P = .004 ) but not for PS ( P = .102 ) .
RESULTS	Failure rates in the access closure substudy analyses demonstrated noninferiority of PG ( 6 % ; P = .005 ) , but not of PS ( 12 % ; P = .100 ) , vs FE ( 10 % ) .
RESULTS	Compared with FE , PG and PS yielded significantly shorter times to hemostasis and procedure completion and favorable trends in blood loss , groin pain , and overall quality of life .
RESULTS	Initial noninferiority test results persist to 6 months , and no aneurysm rupture , conversion to open repair , device migration , or stent graft occlusion occurred .
CONCLUSIONS	Among trained operators , PEVAR with an adjunctive preclose technique using the ProGlide closure device is safe and effective , with minimal access-related complications , and it is noninferior to standard open femoral exposure .
CONCLUSIONS	Training , experience , and careful application of the preclose technique are of paramount importance in ensuring successful , sustainable outcomes .

###24697345
OBJECTIVE	The aim of this study was to investigate the efficacy of bladder training before removing the indwelling urinary catheter in patients with acute urinary retention ( AUR ) associated with benign prostatic hyperplasia ( BPH ) .
METHODS	In total , 845 consecutive patients with their first episode of spontaneous AUR associated with BPH were enrolled in this prospective randomized controlled trial .
METHODS	They were randomly assigned to be given either pharmacological treatment combined with bladder training or pharmacological treatment ( tamsulosin 0.2 mg and finasteride 5 mg once daily ) with free drainage of urinary catheter for 7 days , and a trial without catheter ( TWOC ) was performed .
METHODS	Data on patients ' baseline demographics , history of BPH , International Prostate Symptom Score , prostate size , serum prostate-specific antigen , intravesical prostatic protrusion , TWOC success rates and related complications were collected and statistically analysed .
RESULTS	The two groups of spontaneous AUR patients with BPH were given pharmacological treatment combined with bladder training before catheter removal ( n = 440 ) or pharmacological treatment alone ( n = 405 ) for 7 days .
RESULTS	All 845 patients underwent a first TWOC with an overall success rate of 66.9 % after first 7 days ' catheterization ; TWOC was successful in 65.2 % of cases in the intervention group and 68.6 % in the control group .
RESULTS	There was no statistically significant difference in TWOC success rate between the two groups ( p > 0.05 ) .
CONCLUSIONS	This randomized controlled trial showed that bladder training before urinary catheter removal did not increase the chance of TWOC success significantly in spontaneous AUR patients with BPH .

###25124303
BACKGROUND	Abstinence from chronic cocaine use is associated with abnormal sleep architecture .
BACKGROUND	As sleep abnormalities are associated with clinical outcome in alcohol dependence , we hypothesized a similar relationship in cocaine dependence .
METHODS	We report data from a cocaine self-administration study ( N = 12 ) and the placebo arm of a randomized clinical trial ( N = 20 ) .
METHODS	Self-administration participants underwent three cocaine self-administration sessions during a three-week inpatient stay .
METHODS	Treatment participants underwent two weeks of inpatient followed by six weeks of outpatient treatment including once-weekly cognitive behavioral therapy .
METHODS	Measurements included polysomnography from early and late in abstinence during the inpatient stays .
METHODS	Clinical outcomes included amount of cocaine self-administered , urine tests , and self-reported use and withdrawal symptoms .
RESULTS	Change in slow-wave sleep from early to late abstinence ( SWS ; p = 0.05 ) , late abstinence rapid eye movement sleep ( REM ; p = 0.002 ) , and late abstinence total sleep time ( p = 0.02 ) were negatively correlated with the amount of cocaine self-administered .
RESULTS	Early abstinence REM was positively correlated with withdrawal symptoms ( p = 0.02 ) .
RESULTS	Late abstinence REM was positively correlated with percent negative urines and maximum consecutive number of days abstinent ( both p < 0.001 ) .
RESULTS	SWS was positively correlated with percent negative urines ( p = 0.03 ) and participants with increased SWS had greater percent negative urines ( p = 0.008 ) and maximum consecutive number of days abstinent ( p = 0.009 ) .
CONCLUSIONS	Correlations between sleep deficits and amount of cocaine self-administered , clinical outcomes , and severity of withdrawal symptoms underscore the relevance of sleep in clinical outcomes in the treatment of cocaine dependence .

###25569524
METHODS	Randomized trial with a concurrent observational cohort study .
OBJECTIVE	To compare 8-year outcomes of surgery with nonoperative care for symptomatic lumbar spinal stenosis .
BACKGROUND	Surgery for spinal stenosis has been shown to be more effective than nonoperative treatment during 4 years , but longer-term data are less clear .
METHODS	Surgical candidates from 13 centers in 11 US states with at least 12 weeks of symptoms and confirmatory imaging were enrolled in a randomized cohort or observational cohort .
METHODS	Treatment was standard , decompressive laminectomy versus standard nonoperative care .
METHODS	Primary outcomes were SF-36 ( MOS 36-Item Short-Form Health Survey ) Bodily Pain and Physical Function scales and the modified Oswestry Disability Index assessed at 6 weeks , 3 months , 6 months , and yearly up to 8 years .
RESULTS	Data were obtained for 55 % of participants in the randomized group and 52 % of participants in the observational group at the 8-year follow-up .
RESULTS	Intent-to-treat analyses showed no differences between randomized cohorts ; however , 70 % of those randomized to surgery and 52 % of those randomized to nonoperative had undergone surgery by 8 years .
RESULTS	As-treated analyses in the randomized group showed that the early benefit for surgery out to 4 years converged over time , with no significant treatment effect of surgery seen in years 6 to 8 for any of the primary outcomes .
RESULTS	In contrast , the observational group showed a stable advantage for surgery in all outcomes between years 5 and 8 .
RESULTS	Patients who were lost to follow-up were older , less well-educated , sicker , and had worse outcomes during the first 2 years in both surgical and nonoperative arms .
CONCLUSIONS	Patients with symptomatic spinal stenosis show diminishing benefits of surgery in as-treated analyses of the randomized group between 4 and 8 years , whereas outcomes in the observational group remained stable .
CONCLUSIONS	Loss to follow-up of patients with worse early outcomes in both treatment groups could lead to overestimates of long-term outcomes but likely not bias treatment effect estimates .

###24450367
METHODS	Controlled , repeated-measures , single-blind randomized study .
OBJECTIVE	To determine the effect of cervical or thoracic manipulation on neurotensin , oxytocin , orexin A , and cortisol levels .
BACKGROUND	Previous studies have researched the effect of spinal manipulation on pain modulation and/or range of movement .
BACKGROUND	However , there is little knowledge of the biochemical process that supports the antinociceptive effect of spinal manipulation .
METHODS	Thirty asymptomatic subjects were randomly divided into 3 groups : cervical manipulation ( n = 10 ) , thoracic manipulation ( n = 10 ) , and nonmanipulation ( control ) ( n = 10 ) .
METHODS	Blood samples were extracted before , immediately after , and 2 hours after each intervention .
METHODS	Neurotensin , oxytocin , and orexin A were determined in plasma using enzyme-linked immuno assay .
METHODS	Cortisol was measured by microparticulate enzyme immuno assay in serum samples .
RESULTS	Immediately after the intervention , significantly higher values of neurotensin ( P < .05 ) and oxytocin ( P < .001 ) levels were observed with both cervical and thoracic manipulation , whereas cortisol concentration was increased only in the cervical manipulation group ( P < .05 ) .
RESULTS	No changes were detected for orexin A levels .
RESULTS	Two hours after the intervention , no significant differences were observed in between-group analysis .
CONCLUSIONS	The mechanical stimulus provided by spinal manipulation triggers an increase in neurotensin , oxytocin , and cortisol blood levels .
CONCLUSIONS	Data suggest that the initial capability of the tissues to tolerate mechanical deformation affects the capacity of these tissues to produce an induction of neuropeptide expression .

###24926781
OBJECTIVE	To identify the risk-predictive baseline profile patterns of demographic , genetic , immunologic , and metabolic markers and synthesize these patterns for risk prediction .
METHODS	RuleFit is used to identify the risk-predictive baseline profile patterns of demographic , immunologic , and metabolic markers , using 356 subjects who were randomized into the control arm of the prospective Diabetes Prevention Trial-Type 1 ( DPT-1 ) study .
METHODS	A novel latent trait model is developed to synthesize these baseline profile patterns for disease risk prediction .
METHODS	The primary outcome was Type 1 Diabetes ( T1D ) onset .
RESULTS	We identified ten baseline profile patterns that were significantly predictive to the disease onset .
RESULTS	Using these ten baseline profile patterns , a risk prediction model was built based on the latent trait model , which produced superior prediction performance over existing risk score models for T1D .
CONCLUSIONS	Our results demonstrated that the underlying disease progression process of T1D can be detected through some risk-predictive patterns of demographic , immunologic , and metabolic markers .
CONCLUSIONS	A synthesis of these patterns provided accurate prediction of disease onset , leading to more cost-effective design of prevention trials of T1D in the future .

###25527666
BACKGROUND	Vitamin D is a potent immunomodulator , but its impact on morbidity and mortality among infants remains unclear .
OBJECTIVE	The objective of the study was to prospectively assess the association of vitamin D status with mortality , morbidity , and growth during the first 2 y of life .
METHODS	A prospective cohort of 253 HIV-infected and 948 HIV-exposed Tanzanian infants enrolled in a randomized trial of multivitamins ( not including vitamin D ) was studied .
METHODS	Serum 25-hydroxyvitamin D [ 25 ( OH ) D ] concentrations were measured at 5-7 wk of age and infants were followed at monthly clinic visits until 24 mo. .
METHODS	Physicians performed a clinical exam every 3 mo or when an illness was noted .
RESULTS	Serum 25 ( OH ) D concentrations were ( means SDs ) 18.6 10.3 ng/mL and 18.1 9.2 ng/mL for HIV-infected and HIV-exposed infants , respectively .
RESULTS	Unexpectedly , serum 25 ( OH ) D concentrations 30 ng/mL were significantly associated with higher mortality as compared to the 20-29 .9 ng/mL reference for HIV-infected ( HR : 2.47 ; 95 % CI : 1.13 , 5.44 ; P = 0.02 ) and HIV-exposed ( HR : 4.00 ; 95 % CI : 1.67 , 9.58 ; P < 0.01 ) infants after multivariate adjustment .
RESULTS	We found no statistically significant association between 25 ( OH ) D concentrations < 10 ng/mL and mortality for HIV-infected ( HR : 1.43 ; 95 % CI : 0.74 , 2.78 ; P = 0.29 ) and HIV-exposed ( HR : 1.56 ; 95 % CI : 0.60 , 4.03 ; P = 0.36 ) infants .
RESULTS	Among HIV-exposed infants , 25 ( OH ) D concentrations 30 ng/mL were significantly associated with clinical [ incidence ratio rate ( IRR ) : 1.34 ; 95 % CI : 1.06,1.70 ; P = 0.02 ] and confirmed ( IRR : 1.71 ; 95 % CI : 1.71 ; 1.15 , 2.54 ; P < 0.01 ) malaria diagnoses , whereas concentrations of < 10 ng/mL were associated with oral candidiasis ( IRR : 1.47 ; 95 % CI : 1.00-2 .15 ; P = 0.046 ) and wasting ( HR : 1.71 ; 95 % CI : 1.20 , 2.43 ; P < 0.01 ) .
CONCLUSIONS	The observational design of this study does not allow for causal interpretation ; however , the results indicate a strong need for additional studies of vitamin D among HIV-infected and - exposed children , particularly in malaria-endemic settings .
CONCLUSIONS	The parent trial was registered at clinicaltrials.gov as NCT00197730 .

###24434093
OBJECTIVE	Benzodiazepines , other anxiolytics , or sedative hypnotics are prescribed for 30 % -50 % of posttraumatic stress disorder ( PTSD ) patients .
OBJECTIVE	Prior data and theory suggest that these medications may inhibit response to exposure therapy , one of the most effective PTSD treatments .
OBJECTIVE	The present post hoc study reanalyzed results from a psychotherapy trial to assess whether benzodiazepine use was associated with reduced response to exposure therapy .
METHODS	Between August 2002 and October 2005 , 283 female veterans and soldiers meeting DSM-IV criteria for PTSD were randomly assigned to 10 weekly 90-minute sessions of either prolonged exposure ( n = 140 ) or present-centered psychotherapy ( n = 143 ) .
METHODS	Benzodiazepine use ( n = 57 ) or non-use ( n = 226 ) at intake was not randomly assigned .
METHODS	Multilevel modeling was used to assess the effects of benzodiazepine status , psychotherapy condition , and their interaction on changes on the Clinician-Administered PTSD Scale and the PTSD Checklist during the treatment and 6-month follow-up periods .
RESULTS	Consistent with prior reports from these data , prolonged exposure psychotherapy produced greater reductions per week in PTSD symptoms than did present-centered psychotherapy ( b = -0.48 , P = .02 ) .
RESULTS	Patients prescribed benzodiazepines did not have weaker response to prolonged exposure , but demonstrated poorer posttreatment maintenance of gains from present-centered psychotherapy ( b = -0.78 , P < .001 ) .
CONCLUSIONS	Prolonged exposure is a sufficiently robust treatment that patients who are taking benzodiazepines can benefit from it .
CONCLUSIONS	It is unclear whether benzodiazepine use or other patient factors accounted for benzodiazepine recipients ' poorer maintenance of gains in present-centered psychotherapy .
BACKGROUND	ClinicalTrials.gov identifier : NCT00032617 .

###24674976
OBJECTIVE	The effects of hypoxic training on exercise performance remain controversial .
OBJECTIVE	Here , we tested the hypotheses that i ) hypoxic training possesses ergogenic effects at sea level and altitude and ii ) the benefits are primarily mediated by improved mitochondrial function of the skeletal muscle .
METHODS	We determined aerobic performance ( incremental test to exhaustion and time trial for a set amount of work ) in moderately trained subjects undergoing 6 wk of endurance training ( 3-4 times per week , 60 min per session ) in normoxia ( placebo , n = 8 ) or normobaric hypoxia ( FIO2 = 0.15 , n = 9 ) using a double-blind and randomized design .
METHODS	Exercise tests were performed in normoxia and acute hypoxia ( FIO2 = 0.15 ) .
METHODS	Skeletal muscle mitochondrial respiratory capacities and electron coupling efficiencies were measured via high-resolution respirometry .
METHODS	Total hemoglobin mass was assessed by carbon monoxide rebreathing .
RESULTS	Skeletal muscle respiratory capacity was not altered by training or hypoxia ; however , electron coupling control respective to fat oxidation slightly diminished with hypoxic training .
RESULTS	Hypoxic training did increase total hemoglobin mass more than the placebo ( 8.4 % vs 3.3 % , P = 0.02 ) .
RESULTS	In normoxia , hypoxic training had no additive effect on maximal measures of oxygen uptake or time trial performance .
RESULTS	In acute hypoxia , hypoxic training conferred no advantage on maximal oxygen uptake but tended to enhance time trial performance more than normoxic training ( 52 % vs 32 % , P = 0.09 ) .
CONCLUSIONS	Our data suggest that , in moderately trained subjects , 6 wk of hypoxic training possesses no ergogenic effect at sea level .
CONCLUSIONS	It is not excluded that hypoxic training might facilitate endurance capacity at moderate altitude ; however , this issue is still open and needs to be further examined .

###25749598
BACKGROUND	In this randomized trial , Project CARE , we examined whether participation in a cognitive-behavioral stress management and breast cancer wellness and education program improved psychological outcomes among a sample of underserved black breast cancer survivors .
METHODS	Both complementary medicine interventions were 10-sessions , manualized , group-based , and were culturally adapted for black women in the community from evidence-based interventions .
METHODS	Participants were 114 black women ( mean age = 51.1 , 27-77 years ) who had completed breast cancer treatment 0-12 months before enrollment ( stages 0-IV , mean time since cancer diagnosis = 14.1 months ) .
METHODS	Women were enrolled upon completion of curative treatment ( ie , surgical , chemotherapy , radiation oncology ) and randomized to receive cognitive-behavioral stress management or cancer wellness and education program .
RESULTS	There was a remarkable 95 % retention rate from baseline to 6-month follow-up .
RESULTS	Participants in both conditions showed statistically significant improvement on indices of psychological well-being , including overall quality of life ( Functional Assessment of Cancer Therapy-Breast ) , intrusive thoughts ( Impact of Event Scale-Revised ) , depressive symptoms ( Center for Epidemiologic Studies-Depression ) , and stress levels ( Perceived Stress Scale ) over the 6-month postintervention follow-up ( all repeated measures analysis of variance within-subjects time effects : P < .05 , except for overall mood ; Profile of Mood States-Short Version ) .
RESULTS	Contrary to hypotheses , however , condition time effects were not statistically significant .
CONCLUSIONS	Findings suggest that improvements in multiple measures over time may have been due to intensive training in stress management , extensive provision of breast cancer information , or participation in an ongoing supportive group of individuals from a similar racial background .
CONCLUSIONS	Implications bear on decisions about appropriate control groups , the timing of intervention delivery during the treatment trajectory , and perceived support from the research team .

###24509962
BACKGROUND	The treatment of acne can be difficult , with suboptimal adherence resulting in poor treatment outcomes .
OBJECTIVE	To determine whether demonstrating to patients how to properly apply a topical acne medication through the use of a sample product will improve adherence .
METHODS	Subjects with mild to moderate acne were instructed to use adapalene/benzoyl peroxide gel once daily for six weeks .
METHODS	Subjects were randomized into sample or no sample group .
METHODS	Sample group received a demonstration on how to apply the medication using a product sample .
METHODS	The primary outcome was median adherence , recorded using electronic monitoring , and secondary outcomes were efficacy measures including the Acne Global Assessment ( AGA ) and lesion counts and the Perceived Medical Condition Self-Management Scale ( PMCSMS ) .
RESULTS	Data from 17 patients was collected and analyzed .
RESULTS	Median adherence rates were 50 % in the sample group and 35 % in the no sample group ( p = 0.67 ) .
RESULTS	The median percent improvement in non-inflammatory lesions were 46 % for the sample group and 33 % for the no-sample group ( p = 0.10 ) .
CONCLUSIONS	The small size of this pilot study limited the extent of subgroup analyses .
CONCLUSIONS	Objective electronic monitoring expanded our previous observations of poor adherence in the treatment of acne .
CONCLUSIONS	There is a considerable potential effect size on adherence for the use of samples , supporting the need for future , well powered studies to assess the value of using samples in the treatment of acne and other dermatologic skin diseases .

###24736279
OBJECTIVE	High blood pressure ( BP ) is commonly not diagnosed , and patients do not achieve target values when treated .
OBJECTIVE	Among 20,000 patients encompassing most races-ethnicities , we evaluated BP measurements and treatment response in a stroke prevention trial .
OBJECTIVE	Our goal was to identify BP measurement differences between clinical trial and patient determinations and among the racial-ethnic groups .
METHODS	A total of 20,332 patients with ischemic stroke were randomized to receive antiplatelet treatment and 80 mg of telmisartan versus placebo .
METHODS	BP measurements were obtained at the first clinic visit and then 1 and 3 months later and every 6 months thereafter .
METHODS	One week after the first clinic visit , patients were requested to report a BP measurement obtained elsewhere .
METHODS	Measurements at the trial clinics were obtained with the same electronic device .
METHODS	Statistical analysis was used to detect significant differences .
RESULTS	The mean patient age was 66 years ; 36 % were women , and race-ethnicity comprised 58 % Whites , 33 % Asian , 4.9 % Hispanic , and 4 % Black .
RESULTS	Overall , 74 % of patients were hypertensive .
RESULTS	BP varied between the race-ethnicity groups , being highest in Hispanics ( 145/85 ) and lowest in Blacks ( 144/82 ) .
RESULTS	BP at visits clinic 1 , nonclinic 1A , and clinic 2 were , respectively , 144/84 , 137/80 , and 139/81 mmHg , with the difference between visits 1-2 and visit 1A being significant .
RESULTS	BPs were normal in 42 % of the cases at visit 1A , and of these , only 44 % were normal at visit 1 and 57.6 % were normal on visit 2 .
RESULTS	Similar findings were noted for all race-ethnicity groups .
CONCLUSIONS	BP values varied among race-ethnicities and showed differences between clinic and patient measurements .
CONCLUSIONS	This finding questions the reliability of self-reported BP and has implications for BP management in daily clinical practice .

###25079928
OBJECTIVE	To assess the incremental cost and cost-effectiveness of continuous and discontinuous regimens of bevacizumab ( Avastin ) and ranibizumab ( Lucentis ) for neovascular age-related macular degeneration ( nAMD ) from a UK National Health Service ( NHS ) perspective .
METHODS	A within-trial cost-utility analysis with a 2-year time horizon , based on a multicentre factorial , non-inferiority randomised controlled trial .
METHODS	23 hospital ophthalmology clinics .
METHODS	610 patients aged 50years with untreated nAMD in the study eye .
METHODS	0.5 mg ranibizumab or 1.25 mg bevacizumab given continuously ( monthly ) or discontinuously ( as-needed ) for 2years .
METHODS	Quality-adjusted life-years ( QALYs ) .
RESULTS	Total 2-year costs ranged from 3002/patient ( $ 4700 ; 95 % CI 2601 to 3403 ) for discontinuous bevacizumab to 18590/patient ( $ 29106 ; 95 % CI 18258 to 18922 ) for continuous ranibizumab .
RESULTS	Ranibizumab was significantly more costly than bevacizumab for both continuous ( +14989 / patient ( $ 23468 ) ; 95 % CI 14522 to 15456 ; p < 0.001 ) and discontinuous treatment ( +8498 ( $ 13305 ) ; 95 % CI 7700 to 9295 ; p < 0.001 ) , with negligible difference in QALYs .
RESULTS	Continuous ranibizumab would only be cost-effective compared with continuous bevacizumab if the NHS were willing to pay 3.5 million ( $ 5.5 million ) per additional QALY gained .
RESULTS	Patients receiving continuous bevacizumab accrued higher total costs ( +599 ( $ 938 ) ; 95 % CI 91 to 1107 ; p = 0.021 ) than those receiving discontinuous bevacizumab , but also accrued non-significantly more QALYs ( +0.020 ; 95 % CI -0.032 to 0.071 ; p = 0.452 ) .
RESULTS	Continuous bevacizumab therefore cost 30220 ( $ 47316 ) per QALY gained versus discontinuous bevacizumab .
RESULTS	However , bootstrapping demonstrated that if the NHS is willing to pay 20000/QALY gained , there is a 37 % chance that continuous bevacizumab is cost-effective versus discontinuous bevacizumab .
CONCLUSIONS	Ranibizumab is not cost-effective compared with bevacizumab , being substantially more costly and producing little or no QALY gain .
CONCLUSIONS	Discontinuous bevacizumab is likely to be the most cost-effective of the four treatment strategies evaluated in this UK trial , although there is a 37 % chance that continuous bevacizumab is cost-effective .
BACKGROUND	ISRCTN92166560 .

###24793711
OBJECTIVE	To evaluate two low-dose volumes ( 20 mL or 30 mL ) of 1.5 % mepivacaine solution used for ultrasound-guided axillary blockade for outpatients undergoing distal upper limb surgery .
METHODS	Prospective , double-blinded randomized study .
METHODS	Outpatient surgical setting of a university-affiliated hospital .
METHODS	64 adult , ASA physical status 1 , 2 , and 3 patients , aged 28-46 years , scheduled for upper limb surgery .
METHODS	Patients were randomized to two groups to receive either 20 mL of 1.5 % mepivacaine solution ( n = 31 ) or 30 mL of 1.5 % mepivacaine solution ( n = 33 ) for ultrasound-guided axillary plexus blockade .
METHODS	Block duration , proportion of surgical and functional successful blocks , onset of sensory and motor blockade measured from 0 to 30 minutes following final needle extraction , total amount of preoperative sedative ( midazolam ) , and intraoperative propofol administered were recorded .
RESULTS	Following axillary plexus blockade , neither patient group showed any statistically significant difference in the percentage of functionally successful blockade ( 30 mL , 100 % : 20 mL , 97 % ; P = 0.48 ) , surgically successful blockade ( 30 mL , 100 % ; 20 mL , 94 % ; P = 0.23 ) , cumulative sensory or motor blockade surgical time , block performance time , preoperative midazolam use , or intraoperative propofol use .
CONCLUSIONS	Low volumes ( 30 mL or 20 mL ) of 1.5 % mepivacaine provides satisfactory anesthesia for ambulatory distal upper limb surgery with no significant difference in clinical outcomes .

###24504688
OBJECTIVE	To assess the effect of dimeticone and pepsin on the bioavailability of metoclopramide ( CAS 7232-21-5 ) in healthy volunteers .
METHODS	The study was conducted using a randomized , open , 2-period crossover design .
METHODS	The volunteers received single administration of 7-mg conventional metoclopramide capsule and a formulation containing metoclopramide ( 7mg ) plus dimeticone ( 40mg ) and pepsin ( 50mg ) , with a 7-day interval between treatments .
METHODS	Serial blood samples were collected before dosing and during 24h post-treatment .
METHODS	Plasma metoclopramide concentrations were analyzed by liquid chromatography coupled with tandem mass spectrometry ( LC-MS/MS ) .
METHODS	The pharmacokinetics parameters AUC ( last ) and C ( max ) were obtained from the metoclopramide plasma concentration vs. time curves .
RESULTS	Metoclopramide 's association was bioequivalent to conventional capsule ; 90 % CIs for geometric mean treatment ratios of C ( max ) [ 108.0 % ( 90 % CI , 100.4-116 .3 % ) ] , AUC ( last ) [ 103.3 % ( 90 % CI , 99.5-107 .4 % ) ] were within the predefined range .
RESULTS	The metoclopramide formulations were well tolerated at the administered doses and no significant adverse reactions were observed .
RESULTS	Thus , these results confirm the good bioavailability of metoclopramide in the new formulation and rule out any impaired absorption when the drugs are formulated in combination .

###24291366
OBJECTIVE	Esophageal variceal bleed is a major problem in patients with cirrhosis .
OBJECTIVE	Endoscopic variceal ligation ( EVL ) has been shown to be equal to or better than propranolol in preventing first bleed .
OBJECTIVE	Carvedilol is a non-selective blocker with alpha-1 adrenergic blocker activity .
OBJECTIVE	Hemodynamic studies have shown carvedilol to be more effective than propranolol at reducing portal pressure .
OBJECTIVE	We compared efficacy of carvedilol with EVL for primary prophylaxis of esophageal variceal bleed .
METHODS	Cirrhotic patients with esophageal varices were randomized to carvedilol 12.5 mg daily or EVL at three university hospitals of Pakistan .
METHODS	End points were esophageal variceal bleeding , death or liver transplant .
RESULTS	Two hundred and nine patients were evaluated .
RESULTS	Eighty two and eighty six patients were randomized in carvedilol and EVL arms respectively .
RESULTS	Mean age was 48 12.2 years ; 122 ( 72.7 % ) were males ; 89.9 % had viral cirrhosis ; mean Child-Pugh score was 7.3 1.6 and mean follow up was 13.3 12.1 months ( range 1-50 months ) .
RESULTS	Both EVL and carvedilol groups had comparable variceal bleeding rates ( 8.5 % vs. 6.9 % ) , bleed related mortality ( 4.6 % vs. 4.9 % ) and overall mortality ( 12.8 % vs. 19.5 % ) respectively .
RESULTS	Adverse events in carvedilol group were hypotension ( n = 2 ) , requiring cessation of therapy , while transient nausea ( n = 18 ) and dyspnea ( n = 30 ) resolved spontaneously .
RESULTS	In the EVL arm , post banding ulcer bleed ( n = 1 ) and chest pain ( n = 17 ) , were termed as serious adverse events while transient dysphagia ( n = 58 ) resolved without treatment .
CONCLUSIONS	Although our study is underpowered , the findings suggest that carvedilol is probably not superior to EVL in preventing first variceal bleed in patients with viral cirrhosis .

###25064363
OBJECTIVE	The aim of this study is to systematically investigate under standardized experimental conditions the effects of instrument contamination and wear on the quality of bipolar vessel sealing ( BVS ) achieved using a reusable instrument .
METHODS	The study was designed as a prospective , randomized , and controlled in vitro study and conducted in an academic research environment .
METHODS	Reusable bipolar coagulation forceps ( BiClamp 200 C , ERBE Elektromedizin ) were used to apply sealing pressures of 300-1 ,100 mN/mm ( 2 ) to 239 renal arteries from commercially slaughtered female pigs ( Swabian-Hall Swine ) .
METHODS	Forceps jaws were coated with porcine blood , blood and collagen , or blood , collagen , and fat to simulate instrument contamination with biological material during surgery .
METHODS	Clinical wear was mimicked by sandpaper abrasion .
METHODS	The main outcome measures were seal success ( resistance to 250 mmHg intraluminal pressure for 2 min ) and seal stability ( burst pressure ) .
RESULTS	Sealing pressure had a significant impact , with 800 mN/mm ( 2 ) producing the best sealing results .
RESULTS	Seal success increased with total energy applied to the tissue , a higher maximum temperature , and longer coagulation as indicated by desiccation time .
RESULTS	Experimental contamination had no significant impact on seal success and only a limited effect on seal stability .
RESULTS	Similarly , abrasive wear also had no significant effect on either seal quality or seal strength .
CONCLUSIONS	The impact of bipolar forceps contamination and wear on seal success and quality was negligible in our in vitro model .
CONCLUSIONS	To achieve high-quality seals , it is essential to use adequate sealing pressures .
CONCLUSIONS	Our findings could have direct implications for the design and clinical handling of BVS instruments .

###24262593
OBJECTIVE	Antispasmodic agents have been used in the management of irritable bowel syndrome .
OBJECTIVE	However , systematic reviews have come to different conclusions about the efficacy in irritable bowel syndrome .
OBJECTIVE	Fenoverine acts as a synchronizer of smooth muscle in modulating the intracellular influx of calcium .
OBJECTIVE	We compared fenoverine with trimebutine for the treatment of patients with IBS .
METHODS	A multicenter , randomized , double-blind , non-inferiority clinical study was conducted to compared fenoverine with trimebutine .
METHODS	Subjects were randomized to receive either fenoverine ( 100 mg three times a day ) or trimebutine ( 150 mg three times a day ) for 8 weeks .
METHODS	A total of 197 patients were analyzed by the intention-to-treat approach .
METHODS	The primary endpoint was the proportion of patients who had 30 % reduction in abdominal pain or discomfort measured by bowel symptom scale ( BSS ) score at week 8 compared to the baseline .
METHODS	The secondary endpoints were changes of abdominal bloating , diarrhea , constipation , overall and total scores of BSS , and overall satisfaction .
RESULTS	At week 8 , fenoverine was shown to be non-inferior to trimebutine ( treatment difference , 1.76 % ; 90 % CI , -10.30 -13.82 ; p = 0.81 ) ; 69.23 % ( 54 of 78 patients ) of patients taking fenoverine and 67.47 % ( 56 of 83 patients ) of patients taking trimebutine showed 30 % reduction in abdominal pain or discomfort compared to the baseline .
RESULTS	There results of the secondary endpoints were also comparable between the fenoverine group and the trimebutine group .
CONCLUSIONS	Fenoverine is non-inferior to trimebutine for treating IBS in terms of both efficacy and tolerability .

###25847900
OBJECTIVE	To evaluate , by means of a prospective randomized study , the efficacy of cinacalcet in the forms of nephrolithiasis associated with primary hyperparathyroidism in both the hypercalcemic and normocalcemic variant .
METHODS	Ten patients suffering from active nephrolithiasis associated with primary hyperparathyroidism ( 4 hypercalcemics and 6 normocalcemics ) , equally divided between males and females , were randomly but not blindly addressed to treatment with potassium citrate and allopurinol , or to the same therapeutic regimen in combination with cinacalcet .
METHODS	The dosage of cinacalcet was optimized for each patient in order to obtain a reduction of parathyroid hormone ( PTH ) within normal limits while enabling the maintenance of adequate calcemic values .
METHODS	All study participants were given the same diet based on a reduction in sodium intake , oxalate-rich foods and animal protein with standardized intake of calcium and an increase in hydration .
METHODS	After a follow up period of 10 months , cinacalcet was associated to standard therapy and diet in patients who were not taken it , conversely cinacalcet was withdrawn in the remaining patients who remained on standard therapeutic regimen and diet .
METHODS	Follow up was continued for a second period of observation of the same duration of the first .
RESULTS	At the end of the period of treatment with cinacalcet , for both variants of hyperparathyroidism , a statistically significant reduction in the overall number and in the diameter of renal stones was found .
CONCLUSIONS	This prospective randomized study shows the effectiveness of cinacalcet used in combination with a diet with normalized calcium intake , in reducing the number and size of urinary stones in hypercalemic and normocalcemic forms of primary hyperparathyroidism .

###25259674
BACKGROUND	Levomilnacipran extended-release ( ER ) is an FDA-approved serotonin norepinephrine reuptake inhibitor ( SNRI ) for treating major depressive disorder ( MDD ) .
BACKGROUND	SF-36v2 Health Survey outcomes from a Phase III , randomized , double-blind , placebo-controlled study ( NCT00969709 ) were evaluated .
METHODS	Prospective and post hoc analyses of SF-36 Mental and Physical Component Summaries ( MCS , PCS ) , and individual domains compared pooled levomilnacipran ER doses ( 40 , 80 , 120 mg/day ) with placebo .
METHODS	Patients ( 18-65 years ) had MDD , depressive episode 8 weeks , and Montgomery-sberg Depression Rating Scale total score 30 .
METHODS	SF-36 score changes from baseline to Week 8 were analyzed using ANCOVA and the observed cases approach ( Intent-to-Treat [ ITT ] Population ) .
METHODS	Minimally important differences ( MID ) evaluated clinical relevance .
RESULTS	Baseline MCS scores reflected marked mental deficits in the ITT Population ( levomilnacipran ER = 529 ; placebo = 175 ) .
RESULTS	MCS change at Week 8 was significantly greater for levomilnacipran ER than placebo ( LSMD [ SE ] = 4.8 [ 1.5 ] ; P = 0.0011 ) ; MID exceeded the 3-point threshold .
RESULTS	Baseline PCS scores suggested minimal physical deficits ; no between-group difference at Week 8 was noted .
RESULTS	LSMD was nominally statistically significant ( P < 0.05 ) for levomilnacipran ER versus placebo in 5 domains ( General Health [ 2.44 ; P = 0.0010 ] , Vitality [ 2.48 ; P = 0.0307 ] , Social Functioning [ 3.25 ; P = 0.0097 ] , Role-Emotional [ 3.38 ; P = 0.0078 ] , Mental Health [ 4.34 ; P = 0.0005 ] ) ; changes in Vitality , Social Functioning , and Mental Health exceeded MID .
CONCLUSIONS	The trial was limited by short duration ; analyses were post hoc and adjustments were not made for multiplicity .
CONCLUSIONS	Statistically significant and clinically meaningful improvement on the MCS and several individual domains suggest overall and dimensional improvement in health-related functioning for patients with MDD treated with levomilnacipran ER versus placebo .

###25697457
OBJECTIVE	To compare best-corrected visual acuity ( BCVA ) and central macular thickness ( CMT ) after 532-nm subthreshold laser grid photocoagulation and threshold laser grid photocoagulation for the treatment of diabetic macular oedema ( DME ) .
METHODS	Twenty-three patients ( 46 eyes ) with binocular DME were enroled in this study .
METHODS	The two eyes of each patient were divided into a subthreshold photocoagulation group and a threshold photocoagulation group .
METHODS	The eyes of the subthreshold group underwent 532-nm patter scan laser system ( PASCAL ) 50 % end point subthreshold laser grid photocoagulation therapy , whereas the threshold photocoagulation group underwent short-pulse grid photocoagulation with a 532-nm PASCAL system .
METHODS	BCVA and CMT were assessed in all patients before treatment , 7 days after treatment , and 1 , 3 , and 6 months after treatment .
RESULTS	After grid photocoagulation , the mean BCVA improved in both the subthreshold group , and the threshold group , and the two groups did not differ statistically significantly from each other .
RESULTS	Similarly , the macular oedema diminished in both groups after treatment , and the two groups did not differ statistically significantly from each other with regard to CMT .
CONCLUSIONS	Both 532-nm subthreshold laser grid photocoagulation and threshold laser grid photocoagulation can improve the visual acuity and reduce CMT in DME patients .

###24387891
OBJECTIVE	The purpose of this study was to investigate the effects of massage therapy compared with occlusal splint therapy on mandibular range of motion ( ROM ) in individuals with temporomandibular disorder ( TMD ) and compare the results with ROM obtained in a group of individuals without this disorder .
METHODS	A blinded randomized clinical trial was conducted .
METHODS	Twenty-eight volunteers with TMD were randomly distributed into either a massage therapy group or an occlusal splint group .
METHODS	Both treatments were provided for 4 weeks .
METHODS	Fourteen individuals without TMD were consecutively allocated to a comparison group .
METHODS	Fonseca anamnestic index was used to characterize TMD and allocate the volunteers to either of the intervention groups or asymptomatic comparison group .
METHODS	Mandibular ROM was evaluated before and after treatment using a digital caliper .
METHODS	Two-way repeated-measures analysis of variance with a post hoc Bonferroni testing was used for intergroup and intragroup comparisons ( level of significance was set to 5 % ) .
METHODS	Cohen d was used to calculate the effect size .
RESULTS	In the intragroup analysis , significant increases in ROM were found for all measures in both the massage and occlusal splint groups ( P < .05 ) .
RESULTS	A small to moderate clinical effect of treatment with the occlusal splint was found regarding right and left lateral excursion in comparison with the massage therapy and asymptomatic comparison groups ( 0.2 < d < 0.5 ) .
CONCLUSIONS	Massage therapy on the masticatory muscles and the use of an occlusal splint lead to an increase in mandibular ROM similar to that of the asymptomatic comparison group with regard to maximum active mouth opening and both right and left excursion in individuals with TMD .

###25128004
BACKGROUND	Evidence exists for the effectiveness of cognitive behaviour therapy for psychosis with moderate effect sizes , but the evidence for cognitive behaviour therapy specifically for distressing voices is less convincing .
BACKGROUND	An alternative symptom-based approach may be warranted and a body of literature has explored distressing voices from an interpersonal perspective .
BACKGROUND	This literature has informed the development of relating therapy and findings from a case series suggested that this intervention was acceptable to hearers and therapists .
METHODS	An external pilot randomized controlled trial ( RCT ) comparing outcomes for 15 patients receiving 16hours ( weekly sessions of one hour ) of relating therapy and their usual treatment with 15 patients receiving only their usual treatment .
METHODS	Participants will be assessed using questionnaires at baseline , 16weeks ( post-intervention ) , and 36weeks ( follow-up ) .
CONCLUSIONS	Expected outcomes will include a refined study protocol and an estimate of the effect size to inform the sample size of a definitive RCT .
CONCLUSIONS	If evidence from a fully powered RCT suggests that relating therapy is effective , the therapy will extend the range of evidence-based psychological therapies available to people who hear distressing voices .
BACKGROUND	Current Controlled Trials ISRCTN registration number 44114663 .
BACKGROUND	Registered on 13 June 2013 .

###25042870
OBJECTIVE	To identify genetic markers capable of predicting the pharmacokinetics , pharmacodynamics , and adverse effects of risperidone .
METHODS	Genotyping was performed in 70 healthy volunteers receiving a single 1mg oral dose of risperidone .
METHODS	Risperidone and hydroxyrisperidone plasma levels were measured using high-performance liquid chromatography combined with tandem mass spectrometry.Prolactin concentration was quantified by direct chemiluminescence .
RESULTS	Poor CYP2D6 metabolizers showed higher risperidone Cmax , area under the curve ( AUC ) , and t1/2 , as well as lower clearance .
RESULTS	They also showed lower Cmax and AUC and higher t1/2 for hydroxyrisperidone .
RESULTS	Furthermore , individuals with a mutant VKORC1 genotype had a lower risperidone AUC and t1/2 and higher clearance .
RESULTS	The hydroxyrisperidone AUC was lower in individuals with the COMT mutant genotype .
RESULTS	Risperidone increased prolactin levels ( iAUC and iCmax ) , which were higher in women than in men .
RESULTS	The most frequent reactions were somnolence ( 47.1 % ) , headache ( 21.4 % ) , and dizziness ( 17.1 % ) .
RESULTS	Women had neurological effects and headache more frequently than men .
RESULTS	The incidence of headache was associated with polymorphisms in the AGTR1 and NAT2 ; neurological effects were associated with CYP2C19 .
CONCLUSIONS	Differences in the pharmacokinetics of risperidone are due to polymorphisms in CYP2D6 , COMT , and VKORC1 .
CONCLUSIONS	Differences in adverse reactions can be explained by gender and polymorphisms in CYP2C19 , AGTR1 , and NAT2 .

###24506258
OBJECTIVE	To investigate the clinical efficacy of X-ray imaging combined with skin stimulation potential-guided percutaneous radiofrequency thermocoagulation of the Gasserian ganglion for treatment of primary trigeminal neuralgia .
METHODS	This is a prospective , randomized study .
METHODS	Sixty patients with primary trigeminal neuralgia were randomly assigned to a study group or control group .
METHODS	In the study group , the patients underwent X-ray imaging combined with skin stimulation potential-guided percutaneous radiofrequency thermocoagulation of the Gasserian ganglion .
METHODS	The patients in the control group underwent C-arm X-ray-guided puncture through the foramen ovale , and then the puncture needle was microscopically adjusted according to the intensity of the masticatory muscle response and the patients ' reactions .
METHODS	Puncture success , postoperative adverse reactions , and short - and middle-term analgesic efficacies were statistically compared between the two surgical approaches .
RESULTS	The incidence of postoperative side effects was significantly reduced , and immediate and mid-term analgesic efficacy was better in patients in the study group comparing with those in the control group ( P < 0.01 ) .
CONCLUSIONS	Using skin stimulation potential-guided puncture may enable more accurate microscopic adjustment of the targets localization damaged by radiofrequency and significantly enhanced clinical efficacy in this study .

###24415567
OBJECTIVE	To assess pregabalin monotherapy for partial-onset seizures using a historical-controlled conversion-to-monotherapy design .
METHODS	Adults with inadequately controlled partial-onset seizures while receiving 1 or 2 antiepileptic drugs during an 8-week prospective baseline were randomized to double-blind monotherapy with pregabalin 600 or 150 mg/d ( 4:1 ) for 20 weeks ( 8-week conversion and 12-week monotherapy period ) .
METHODS	The primary endpoint was the seizure-related exit rate for pregabalin 600 mg/d , based on discontinuations due to predefined criteria .
METHODS	Efficacy was declared if the upper limit of the 95 % confidence interval for the exit rate was below a historical-control threshold of 74 % , with stepwise evaluation using a threshold of 68 % .
RESULTS	The trial was stopped early for positive efficacy after an interim analysis in 125 patients .
RESULTS	The full study population included 161 patients , with 148 evaluable for efficacy .
RESULTS	The mean time since epilepsy diagnosis was 14 years .
RESULTS	Overall , 54.3 % ( 600 mg/d ) and 46.9 % ( 150 mg/d ) of patients completed 20 weeks of double-blind treatment .
RESULTS	Seizure-related exit rate in the 600 mg/d group ( 27.5 % ; 95 % confidence interval , 17.8 % -37.2 % ) was significantly below the 74 % and 68 % thresholds ( p < 0.001 for both ) .
RESULTS	Eight patients on 600 mg/d and 2 on 150 mg/d were seizure-free throughout pregabalin monotherapy .
RESULTS	Pregabalin 's overall safety profile was consistent with prior trials .
CONCLUSIONS	Pregabalin monotherapy was safe and efficacious for patients with inadequately controlled partial-onset seizures .
METHODS	This study provides Class III evidence that patients with inadequately controlled partial-onset seizures switched to pregabalin monotherapy have fewer seizure-related exit events compared with historical controls switched to pseudo-placebo monotherapy .

###25502179
OBJECTIVE	We investigated the method of switching EPO to CERA that does not cause a decrease in the Hb level .
METHODS	Fifty EPO-treated patients were randomly divided into two groups in which CERA was administered every two weeks ( Q2W ) or every four weeks ( Q4W ) .
METHODS	After 8 weeks of treatment , the frequency of administration was changed to Q4W in the former .
METHODS	Follow-up was performed for 24 weeks .
RESULTS	There was no difference in the Hb level between the two groups until 6 weeks .
RESULTS	In the Q2W group , the Hb maintained a stable level throughout a study period .
RESULTS	However , in the Q4W group , the Hb level was significantly lower than in the Q2W group at weeks 9 , 11 , and 13 .
CONCLUSIONS	EPO switching to CERA without a decrease in the Hb level could be achieved by administering CERA every two weeks , but not every four weeks , for a specific period after switching .

###24295879
BACKGROUND	Cardiovascular disease ( CVD ) and the underlying atherosclerosis begin in childhood , and their presence and intensity are related to known cardiovascular disease risk factors .
BACKGROUND	Attention to risk factor control in childhood has the potential to reduce subsequent risk of CVD .
OBJECTIVE	The Young Hearts Strong Starts Study was designed to test strategies facilitating adoption of the National , Heart , Lung and Blood Institute supported Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents .
OBJECTIVE	This study compares guideline-based quality measures for body mass index , blood pressure , and tobacco using two strategies : a multifaceted , practice-directed intervention versus standard dissemination .
METHODS	Two primary care research networks recruited practices and provided support for the intervention and outcome evaluations .
METHODS	Individual practices were randomly assigned to the intervention or control groups using a cluster randomized design based on network affiliation , number of clinicians per practice , urban versus nonurban location , and practice type .
METHODS	The units of observation are individual children because measure adherence is abstracted from individual patient 's medical records .
METHODS	The units of randomization are physician practices .
METHODS	This results in a multilevel design in which patients are nested within practices .
METHODS	The intervention practices received toolkits and supported guideline implementation including academic detailing , an ongoing e-learning group .
METHODS	This project is aligned with the American Board of Pediatrics Maintenance of Certification requirements including monthly physician self-abstraction , webinars , and other elements of the trial .
CONCLUSIONS	This trial will provide an opportunity to demonstrate tools and strategies to enhance CV prevention in children by guideline-based interventions .

###25977128
BACKGROUND	Checklists may help reduce discharge errors ; however , current paper checklists have limited functionality .
BACKGROUND	In 2013 a best-practice discharge checklist using the electronic health record ( EHR ) was developed and evaluated at Stanford University Medical Center ( Stanford , California ) in a cluster randomized trial to evaluate its usage , user satisfaction , and impact on physicians ' work flow .
METHODS	The study was divided into four phases .
RESULTS	In Phase I , on the survey ( N = 76 ) , most of the participants ( 54.0 % ) reported using memory to remember discharge tasks .
RESULTS	On a 0-100 scale , perception of checklists as being useful was strong ( mean , 66.4 ; standard deviation [ SD ] , 21.2 ) , as was interest in EHR checklists ( 64.5 , 26.6 ) .
RESULTS	In Phase II , the checklist consisted of 15 tasks categorized by admission , hospitalization , and discharge-planning .
RESULTS	In Phase III , the checklist was implemented as an EHR `` smart-phrase '' allowing for automatic insertion .
RESULTS	In Phase IV , in a trial with 60 participating physicians , 23 EHR checklist users reported higher usage than 12 paper users ( 28.5 versus 7.67 , p = .019 ) , as well as higher checklist integration with work flow ( 22.6 versus 1.67 , p = .014 ) , usefulness of checklist ( 33.7 versus .
RESULTS	8.92 , p = .041 ) , discharge confidence ( 30.8 versus 5.00 , p = .029 ) , and discharge efficiency ( 25.5 versus 6.67 , p = .056 ) .
RESULTS	Increasing EHR checklist use was correlated with usefulness ( r = .85 , p < .001 ) , confidence ( r = .81 , p < .001 ) , and efficiency ( r = .87 , p < .001 ) .
CONCLUSIONS	The EHR checklist reminded physicians to complete discharge tasks , improved confidence , and increased process efficiency .
CONCLUSIONS	This is the first study to show that medicine residents use `` memory '' as the most common method for remembering discharge tasks .
CONCLUSIONS	These data reinforce the need for a formalized tool , such as a checklist , that residents can rely on to complete important discharge tasks .

###24672620
BACKGROUND	Coordination of the tasks of performing chest compressions and defibrillation can lead to communication challenges that may prolong time spent off the chest .
BACKGROUND	The purpose of this study was to determine whether defibrillation provided by the provider performing chest compressions led to a decrease in peri-shock pauses as compared to defibrillation administered by a second provider , in a simulated cardiac arrest scenario .
METHODS	This was a randomized , controlled study measuring pauses in chest compressions for defibrillation in a simulated cardiac arrest model .
METHODS	We approached hospital providers with current CPR certification for participation between July , 2011 and October , 2011 .
METHODS	Volunteers were randomized to control ( facilitator-administered defibrillation ) or experimental ( compressor-administered defibrillation ) groups .
METHODS	All participants completed one minute of chest compressions on a mannequin in a shockable rhythm prior to administration of defibrillation .
METHODS	We measured and compared pauses for defibrillation in both groups .
RESULTS	Out of 200 total participants , we analyzed data from 197 defibrillations .
RESULTS	Compressor-initiated defibrillation resulted in a significantly lower pre-shock hands-off time ( 0.57 s ; 95 % CI : 0.47-0 .67 ) compared to facilitator-initiated defibrillation ( 1.49 s ; 95 % CI : 1.35-1 .64 ) .
RESULTS	Furthermore , compressor-initiated defibrillation resulted in a significantly lower peri-shock hands-off time ( 2.77 s ; 95 % CI : 2.58-2 .95 ) compared to facilitator-initiated defibrillation ( 4.25 s ; 95 % CI : 4.08-4 .43 ) .
CONCLUSIONS	Assigning the responsibility for shock delivery to the provider performing compressions encourages continuous compressions throughout the charging period and decreases total time spent off the chest .
CONCLUSIONS	However , as this was a simulation-based study , clinical implementation is necessary to further evaluate these potential benefits .

###25992746
BACKGROUND	The successful treatment of intraabdominal infection requires a combination of anatomical source control and antibiotics .
BACKGROUND	The appropriate duration of antimicrobial therapy remains unclear .
METHODS	We randomly assigned 518 patients with complicated intraabdominal infection and adequate source control to receive antibiotics until 2 days after the resolution of fever , leukocytosis , and ileus , with a maximum of 10 days of therapy ( control group ) , or to receive a fixed course of antibiotics ( experimental group ) for 41 calendar days .
METHODS	The primary outcome was a composite of surgical-site infection , recurrent intraabdominal infection , or death within 30 days after the index source-control procedure , according to treatment group .
METHODS	Secondary outcomes included the duration of therapy and rates of subsequent infections .
RESULTS	Surgical-site infection , recurrent intraabdominal infection , or death occurred in 56 of 257 patients in the experimental group ( 21.8 % ) , as compared with 58 of 260 patients in the control group ( 22.3 % ) ( absolute difference , -0.5 percentage point ; 95 % confidence interval [ CI ] , -7.0 to 8.0 ; P = 0.92 ) .
RESULTS	The median duration of antibiotic therapy was 4.0 days ( interquartile range , 4.0 to 5.0 ) in the experimental group , as compared with 8.0 days ( interquartile range , 5.0 to 10.0 ) in the control group ( absolute difference , -4.0 days ; 95 % CI , -4.7 to -3.3 ; P < 0.001 ) .
RESULTS	No significant between-group differences were found in the individual rates of the components of the primary outcome or in other secondary outcomes .
CONCLUSIONS	In patients with intraabdominal infections who had undergone an adequate source-control procedure , the outcomes after fixed-duration antibiotic therapy ( approximately 4 days ) were similar to those after a longer course of antibiotics ( approximately 8 days ) that extended until after the resolution of physiological abnormalities .
CONCLUSIONS	( Funded by the National Institutes of Health ; STOP-IT ClinicalTrials.gov number , NCT00657566 . )

###24886443
OBJECTIVE	The genetic polymorphism concerning the 3-subunit of platelet integrin receptor glycoprotein IIIa is held responsible for enhanced binding of adhesive proteins resulting in increased thrombogenic potential .
OBJECTIVE	Whether it is associated with mortality , HbA1c or platelet volume is tested prospectively in an epidemiological cohort .
METHODS	Population-based Cooperative Health Research in the Region of Augsburg ( KORA ) S4-Survey ( N = 4,028 ) was investigated for prognostic value of PLA1A2-polymorphism regarding all-cause mortality , correlation with HbA1c , and mean platelet volume .
METHODS	Multivariate analysis was performed to investigate association between genotype and key variables .
RESULTS	Prevalence of thrombogenic allele variant PLA2 was 15.0 % .
RESULTS	Multivariate analysis revealed no association between PLA1A2 polymorphism and mortality in the KORA-cohort .
RESULTS	HbA1c was a prognostic marker of mortality in non-diabetic persons resulting in J-shaped risk curve with dip at HbA1c = 5.5 % ( 37 mmol/mol ) , confirming previous findings regarding aged KORA-S4 participants ( 55-75 years ) .
RESULTS	PLA1A2 was significantly associated with elevated HbA1c levels in diabetic patients ( N = 209 ) and reduced mean platelet volume in general population .
RESULTS	In non-diabetic participants ( N = 3,819 ) , carriers of PLA2 allele variant presenting with HbA1c > 5.5 % ( 37 mmol/mol ) showed higher relative risk of mortality with increasing HbA1c .
CONCLUSIONS	PLA1A2 polymorphism is associated with mortality in participants with HbA1c ranging from 5.5 % ( 37 mmol/mol ) to 6.5 % ( 48 mmol/mol ) .
CONCLUSIONS	Maintenance of euglycemic control and antiplatelet therapy are therefore regarded as effective primary prevention in this group .

###25749596
BACKGROUND	The large placebo effect observed in prior acupuncture trials presents a substantial challenge for interpretation of the efficacy of acupuncture .
BACKGROUND	We sought to evaluate the relationship between response expectancy , a key component of the placebo effect over time , and treatment outcome in real and sham electroacupuncture ( EA ) .
METHODS	We analyzed data from a randomized controlled trial of EA and sham acupuncture ( SA ) for joint pain attributable to aromatase inhibitors among women with breast cancer .
METHODS	Responders were identified using the Patient Global Impression of Change instrument at Week 8 ( end of intervention ) .
METHODS	The Acupuncture Expectancy Scale ( AES ) was used to measure expectancy four times during the trial .
METHODS	Linear mixed-effects models were used to evaluate the association between expectancy and treatment response .
RESULTS	In the wait list control group , AES remained unchanged over treatment .
RESULTS	In the SA group , Baseline AES was significantly higher in responders than nonresponders ( 15.5 vs 12.1 , P = .005 ) and AES did not change over time .
RESULTS	In the EA group , Baseline AES scores did not differ between responders and nonresponders ( 14.8 vs 15.3 , P = .64 ) ; however , AES increased in responders compared with nonresponders over time ( P = .004 for responder and time interaction term ) with significant difference at the end of trial for responders versus nonresponders ( 16.2 vs 11.7 , P = .004 ) .
CONCLUSIONS	Baseline higher response expectancy predicts treatment response in SA , but not in EA .
CONCLUSIONS	Divergent mechanisms may exist for how SA and EA influence pain outcomes , and patients with low expectancy may do better with EA than SA .

###24612081
OBJECTIVE	We aimed to evaluate the effects of raw red onion consumption on metabolic features in overweight and obese women with polycystic ovary syndrome .
METHODS	In this randomized controlled clinical trial , the patients ( n = 54 ) were randomly allocated to the intervention group as ` high-onion ' ( raw red onions : 2 40-50 g/day if overweight and 2 50-60 g/day if obese ) or to the control group as ` low-onion ' ( raw red onions : 2 10-15 g/day ) along with limited liliaceous vegetables for 8 weeks .
METHODS	Body mass index , dietary record , and metabolic parameters ( fasting blood sugar , triglycerides , total cholesterol , low-density lipoprotein cholesterol , high-density lipoprotein cholesterol , and lipoprotein ( a ) ) were evaluated in the follicular phase of the menstrual cycle at baseline and after 8 weeks .
METHODS	Hormonal variables ( progesterone , prolactin , and 17-OH progesterone ) were also measured at baseline .
RESULTS	Onion significantly decreased the levels of total cholesterol within each group ; however , these changes were stronger in the high-onion group ( weighted mean differences [ WMD ] : -5.60 [ 95 % confidence interval [ CI ] : -9.16 , -2.03 ] ; P = 0.003 ) than in the low-onion group ( WMD : -6.42 [ 95 % CI : -11.97 , -0.87 ] ; P = 0.025 ) .
RESULTS	Similarly , low-density lipoprotein cholesterol decreased significantly ( WMD : -5.13 [ 95 % CI : -9.46 , -0.81 ) ; P = 0.022 ) in the high-onion group , and ( WMD : -2.90 [ 95 % CI -5.57 , -0.21 ] ; P = 0.035 ) in the low-onion group after treatment .
RESULTS	The levels of fasting blood sugar , triglycerides , high-density lipoprotein cholesterol and lipoprotein ( a ) did not differ significantly after 8-week onion treatment .
RESULTS	Adjustment for confounders did not make any significant changes in any of the parameters in post-treatment levels .
CONCLUSIONS	Raw red onion consumption appears to be effective as a cholesterol-lowering food agent in women with polycystic ovary syndrome .
CONCLUSIONS	However , further investigation is warranted .

###25440795
BACKGROUND	Elderly patients are at high risk for both ischemic and bleeding events .
BACKGROUND	Platelet monitoring offers the opportunity to individualized antiplatelet therapy to optimize the therapeutic risk/benefit ratio .
METHODS	The ANTARCTIC study is designed to demonstrate the superiority of a strategy of platelet function monitoring with dose and drug adjustment in patients initially on prasugrel 5 mg as compared with a more conventional strategy using prasugrel 5 mg without monitoring and without adjustment ( Conventional Treatment Arm ) to reduce the primary end point evaluated 1 year after stent percutaneous coronary intervention in elderly patients presenting with an acute coronary syndrome ( ACS ) .
METHODS	ANTARCTIC is a multicenter , prospective , open-label study with 2 parallel arms .
METHODS	A total of 852 elderly patients ( 75 years ) undergoing stent percutaneous coronary intervention for ACS are to be enrolled .
METHODS	The primary end point is the time to first occurrence of cardiovascular death , myocardial infarction , stroke , definite stent thrombosis , urgent revascularization , and bleeding complications ( Bleeding Academic Research Consortium definition 2 , 3 , or 5 ) .
METHODS	Platelet function analyses will be performed 14 days after randomization and repeated 14 days later in patients who require a change in treatment .
CONCLUSIONS	ANTARCTIC is a nationwide , prospective , open-label study testing a strategy of platelet function monitoring with dose and drug adjustment to reduce ischemic and bleeding complications in elderly ACS patients undergoing coronary stenting .

###25115901
BACKGROUND	Vaniprevir ( MK-7009 ) is a hepatitis C virus ( HCV ) non-structural 3/4a protease inhibitor which significantly increases virologic response rates in HCV genotype ( GT ) 1-infected patients when added to peginterferon and ribavirin ( PR ) .
METHODS	This was a phase II , multicenter , double-blind , randomized , dose-ranging study in Japanese patients with HCV GT1 infection and previous relapse .
METHODS	Patients received twice daily vaniprevir 100 , 300 , or 600 mg , or placebo plus PR for 4 weeks then PR alone for 2 weeks .
METHODS	Further treatment with PR was continued up to a maximum of 72 weeks .
METHODS	The primary endpoint was rapid virologic response ( RVR ; undetectable HCV RNA at treatment week 4 ) .
RESULTS	Ninety patients completed 4 weeks of vaniprevir/placebo plus PR .
RESULTS	Rates of RVR were significantly higher with vaniprevir compared with placebo ( 86 , 95 , and 76 % in the vaniprevir 100 - , 300 - , and 600-mg arms versus 20 % with control ; p < 0.001 for all comparisons ) .
RESULTS	Rates of SVR , an exploratory analysis , in the vaniprevir 100 - , 300 - , 600-mg , and control arms were 95 , 100 , 100 , and 72 % , respectively .
RESULTS	No patient had virologic breakthrough or non-response while receiving vaniprevir .
RESULTS	There were no serious adverse events ( AEs ) or discontinuations due to an AE during vaniprevir treatment .
RESULTS	Diarrhea and nausea were more common with vaniprevir 600 mg than control or lower vaniprevir doses .
CONCLUSIONS	The addition of vaniprevir to PR was associated with an increase in RVR and SVR .
CONCLUSIONS	Combined with a generally safe and well-tolerated profile , these data supported the further evaluation of vaniprevir in Japanese patients with HCV GT1 infection ( #NCT 00880763 ) .

###24399652
OBJECTIVE	The aim of this study was to gain further understanding of placebo response in binge eating disorder .
METHODS	We pooled participant-level data from 10 double-blind , placebo-controlled , randomized trials of medications for binge eating disorder .
METHODS	The primary outcomes were response ( 75 % reduction in binge eating episodes ) , cessation of binge eating episodes , change in mean weekly binge eating episodes and binge eating episodes per week .
RESULTS	Of 234 participants receiving placebo , 89 ( 38 % ) were responders and 59 ( 26 % ) attained cessation .
RESULTS	Placebo-treated participants significantly reduced their binge eating .
RESULTS	The mean ( SD ) binge eating episodes per week at baseline was 5.2 ( 3.2 ) and at endpoint was 2.2 ( 2.6 ) .
RESULTS	Lower baseline binge eating episode frequency and longer study participation were significantly associated with response and cessation .
CONCLUSIONS	Less severe eating pathology at baseline was associated with higher placebo response and cessation rates .
CONCLUSIONS	Future clinical trials may want to stipulate that participants exceed a threshold of illness severity , which may lead to better placebo and drug separation .

###24946024
BACKGROUND	Although BiPAP has been used as an adjunct to exercise , little is know about its effect on exercise in COPD .
BACKGROUND	We aimed to evaluate the acute effect of BiPAP delivered with a standard valve ( Vision , Respironics ) , compared to no assist , on exercise capacity in individuals with COPD .
METHODS	Peak exercise workload ( WLpeak ) , dyspnea ( Borg ) , end-expiratory lung volume ( EELV ) , tidal volume ( VT ) , minute ventilation ( VE ) , O2 uptake ( VO2 ) , and CO2 production ( VCO2 ) were assessed in 10 COPD patients ( FEV1 53 22 % pred ) during three symptom-limited bicycle exercise tests while breathing i ) without a ventilator ( noPS ) , ii ) with a pressure support ( PS ) of 0 cm H2O ( PS0 ; IPAP & EPAP 4 cm H2O ) and iii ) PS of 10 cm H2O ( PS10 ; IPAP 14 & EPAP 4 cm H2O ) on separate days using a randomized crossover design .
RESULTS	WLpeak was significantly lower with PS10 ( 33 16 ) and PS0 ( 30.5 13 ) than noPS ( 43 19 ) ( p < 0.001 ) .
RESULTS	Dyspnea at peak exercise was similar with noPS , PS0 and PS10 ; at isoload it was lower with noPS compared to PS10 and PS0 ( p < 0.01 ) .
RESULTS	VT and VE were highest with PS10 and lowest with noPS both at peak exercise and isoload ( p < 0.001 ) .
RESULTS	EELV was similar at peak exercise with all three conditions .
RESULTS	VO2 and VCO2 were greater with PS10 and PS0 than noPS ( p < 0.001 ) , both at peak exercise and isoload .
CONCLUSIONS	Use of BiPAP with a standard exhalation valve during exercise increases VT and VE at the expense of augmenting VCO2 and dyspnea , which in turns reduces WLpeak in COPD patients .

###24248424
OBJECTIVE	Heart rate characteristics monitoring for early detection of late-onset neonatal sepsis was first described in 2003 .
OBJECTIVE	This technique , which uses mathematical methods to report the fold-increase in the risk of imminent neonatal sepsis , adds independent information to laboratory tests and clinical findings , and , in a large randomized trial , reduced NICU mortality of very low birth weight infants .
OBJECTIVE	Through re-analysis and new secondary analyses of published studies , we have systematically evaluated the utility of this new risk marker for screening the growing population of premature infants .
METHODS	We followed the guidelines proposed by Hlatky et al. ( Circulation , 119:2408 -2416 , 2009 ) , reviewed past works , and re-analyzed data from 1,489 patients receiving conventional monitoring alone , 348 of whom had 488 episodes of proven sepsis , in the large randomized trial .
RESULTS	Heart rate characteristics monitoring passed all phases of risk marker development from proof of concept to improvement of clinical outcomes .
RESULTS	The predictiveness curve affirmed good calibration , and addition of the heart rate characteristics index to predictive models using standard risk factors favorably impacted the receiver operating characteristic curve area ( increase of 0.030 ) , continuous net reclassification index ( 0.389 ) and the integrated discrimination index ( 0.008 ) , and compares well to other modern risk factors .
CONCLUSIONS	Heart rate characteristics monitoring is a validated risk marker for sepsis in the NICU .

###24708031
OBJECTIVE	Combining a long-acting muscarinic antagonist with a long-acting - agonist has been shown to be pharmacologically useful in patients with chronic obstructive pulmonary disease ( COPD ) .
OBJECTIVE	The aim of the present study was to evaluate the effectiveness of the dual bronchodilator therapy on airway dimensions in COPD .
METHODS	Patients ( n = 54 ) were randomly assigned to receive tiotropium ( 18g once daily ) , indacaterol ( 150g once daily ) or tiotropium plus indacaterol for 16 weeks .
METHODS	Quantitative computed tomography ( CT ) , pulmonary function and health status ( St. George 's Respiratory Questionnaire ) were measured .
RESULTS	Compared with tiotropium or indacaterol alone , combination therapy resulted in a significant decrease in percentage wall area ( WA % ) and wall thickness , corrected for body surface area , and an increase in luminal area ( Ai/BSA ) .
RESULTS	Concurrent treatment was superior to monotherapy in physiological indices , including forced vital capacity , forced expiratory volume in 1s ( FEV ) and inspiratory capacity .
RESULTS	The changes in WA % and Ai/BSA were significantly correlated with changes in FEV ( r = -0.44 , P < 0.01 and r = 0.37 , P < 0.01 ) .
RESULTS	There were more significant improvements in SGRQ scores after treatment with combined therapy than with either treatment alone .
CONCLUSIONS	Concurrent therapy with tiotropium and indacaterol is effective for COPD patients to promote reduction in airway wall thickness , bronchodilation , and improvements in lung function compared with a single inhaler .

###24485998
OBJECTIVE	To determine the subjective and objective outcomes of retroperitoneoscopic vs open pyeloplasty with minimal incision in a prospective randomized comparison study .
METHODS	In this study between August 2011 to July 2013 , 30 patients underwent retroperitoneal laparoscopic pyeloplasty and 30 open pyeloplasty with minimal incision ( incision length < 10 cm ) after randomization .
METHODS	The 2 groups were compared for the visual pain score on the first and second postoperative days as the primary end point of the study .
METHODS	Complications were recorded and graded using Dindo-modified Clavien classification of surgical complications .
METHODS	Success rates were evaluated by improvement in pain score and objectively by diethylene triamine penta-acetic acid renal scan and other parameters .
METHODS	Statistical analysis was performed with SPSS version 16.0 ( IBM ) with P < .05 considered statistically significant .
RESULTS	The difference in the visual pain score ( 5.6 vs 3.2 on day 1 ; 3.8 vs 1.5 on day 2 ) and the diclofenac requirements ( 333.3 vs 178.75 mg ) were statistically significant and more in the open pyeloplasty .
RESULTS	The hospital stay and convalescence were significantly lower in retroperitoneoscopic group .
RESULTS	Success rate was found to be 96.67 % with 1 failure in each group .
RESULTS	Two patients in retroperitoneoscopic group required conversion .
RESULTS	Both groups showed significant improvement in pain score and drainage pattern on diethylene triamine penta-acetic acid scan with decrease in hydronephrosis on ultrasound evaluation .
CONCLUSIONS	Although subjective and objective outcomes are equivalent in both the groups , the retroperitoneoscopic approach is associated with significantly less pain , less analgesic requirement , shorter hospital stay and short convalescence in comparison with open pyeloplasty .

###25139785
BACKGROUND	The stimulant prodrug lisdexamfetamine dimesylate ( LDX ) is an effective and generally well tolerated treatment for the symptoms of attention-deficit/hyperactivity disorder ( ADHD ) .
BACKGROUND	Positive impacts of LDX on health-related quality of life and functional impairment have previously been demonstrated in a 7-week , randomized , double-blind , placebo-controlled , phase III study in children and adolescents in Europe .
BACKGROUND	Maintenance of these broad benefits , as well as symptomatic control , is a key goal of long-term management of ADHD .
OBJECTIVE	Secondary objectives of this multinational study in children and adolescents with ADHD were to assess the long-term maintenance of effectiveness of LDX in improving health-related quality of life and reducing functional impairment , as gauged using the Child Health and Illness Profile-Child Edition : Parent Report Form ( CHIP-CE : PRF ) and the Weiss Functional Impairment Rating Scale-Parent Report ( WFIRS-P ) , respectively .
METHODS	Patients aged 6-17 years with diagnosed ADHD and a baseline ADHD Rating Scale IV total score of at least 28 were enrolled from the previous European study and from US sites .
METHODS	Patients who completed an open-label LDX treatment period of at least 26 weeks were randomized ( 1:1 ) to continue on their optimized dose of LDX or to switch to placebo for a 6-week , double-blind , withdrawal period .
METHODS	Parents completed CHIP-CE : PRF and WFIRS-P questionnaires at weeks 0 , 8 and 26 of the open-label period and at weeks 0 and 6 of the randomized-withdrawal period , or at early termination .
METHODS	The endpoint of each period was defined as the last visit with valid data .
METHODS	Effect sizes were the difference ( LDX minus placebo ) in least-squares ( LS ) - mean change from baseline to endpoint divided by root-mean-square error .
METHODS	P values were nominal and not adjusted for multiple comparisons .
RESULTS	The open-label and randomized full analysis sets comprised 262 and 153 ( LDX n = 76 ; placebo n = 77 ) patients , respectively .
RESULTS	Mean pretreatment CHIP-CE : PRF T-scores were more than one standard deviation below the normative mean in four of the five domains , and there was significant improvement across all domains from baseline to endpoint of the open-label period .
RESULTS	In the randomized-withdrawal period , LS-mean CHIP-CE : PRF T-scores deteriorated in all domains in the placebo group , but not in the LDX group .
RESULTS	Compared with placebo , the effect of LDX was significant in the Risk Avoidance ( effect size 0.829 ; p < 0.001 ) , Achievement ( 0.696 ; p < 0.001 ) and Satisfaction ( 0.636 ; p < 0.001 ) domains .
RESULTS	Mean pretreatment WFIRS-P scores were lowest in the Family domain and the Learning and School domain .
RESULTS	WFIRS-P total score and scores in all domains improved significantly from baseline to endpoint of the open-label period .
RESULTS	In the randomized-withdrawal period , LS-mean scores deteriorated in the placebo group but not in the LDX group .
RESULTS	Compared with placebo , the effect of LDX was significant in the Family , Learning and School , and Risky Activities domains and in total ( effect size 0.908 ; p < 0.001 ) .
CONCLUSIONS	Using parent-rated instruments , long-term maintenance of the beneficial effect of LDX in multiple domains of health-related quality of life and functional impairment was demonstrated by comparison of treatment continuation and withdrawal under randomized , double-blind , placebo-controlled conditions .

###24378016
BACKGROUND	The effects of dietary fatty acid supplementation on lipoprotein fatty acid composition have rarely been described .
METHODS	Sixty-one overweight and obese adults with dyslipidemia and insulin resistance were randomized to placebo , 2g/day extended-release nicotinic acid ( ERN ) , 4g/day prescription omega-3 fatty acid ethyl ester ( P-OM3 ) , or combination therapy for 16 weeks .
METHODS	Lipoprotein fatty acid composition was analyzed by gas chromatography pre - and post-treatment .
RESULTS	Treatment with P-OM3 or combination , but not ERN , increased proportions of eicosapentaenoic acid , docosahexaenoic acid , and docosapentaenoic acid , and reduced those for arachidonic acid in all lipoprotein fractions , with greatest impact in the high-density lipoprotein fraction .
RESULTS	P-OM3-induced changes in eicosapentaenoic acid within low-density lipoproteins and very low-density lipoproteins were associated with beneficial effects on mean arterial pressure and pulse pressure .
CONCLUSIONS	P-OM3 supplementation , with or without ERN , was associated with differentially altered lipoprotein fatty acid composition and improved blood pressure parameters .

###25500487
OBJECTIVE	To evaluate the pharmacokinetics of oral canagliflozin and its O-glucuronide metabolites ( M7 and M5 ) after single and multiple doses in healthy adult participants .
OBJECTIVE	The pharmacodynamics , safety , and tolerability of canagliflozin were also evaluated .
METHODS	In this open-label , single - ( day 1 ) and multiple-dose ( days 4-9 ) , parallel-group , phase 1 study , 27 healthy participants were randomized into three groups ( 1:1:1 ) to receive 50 , 100 , or 300 mg canagliflozin .
METHODS	Pharmacokinetics and pharmacodynamics were assessed at pre-pecified timepoints on days 1 , 9 , and 10 .
RESULTS	Mean area under the plasma concentration-time curve , and the maximum observed plasma concentration of canagliflozin , M7 , and M5 increased in a dose-dependent manner , across all the 3 doses , following single - and multiple-dose administration .
RESULTS	The mean apparent elimination half-lives of canagliflozin , M7 , and M5 were independent of the dose .
RESULTS	Canagliflozin decreased the renal threshold for glucose ( RTG ) and increased the urinary glucose excretion ( UGE ) in a concentration - and dose-dependent manner .
RESULTS	The relationship between drug concentrations and RTG was described by a sigmoidal relationship with RTGmin ( minimum value of RTG ) of 37.5 ng/mL ( 95 % confidence interval ( CI ) : 34.3 , 40.8 ) and half-maximal effective concentration ( EC50 ) of 21 ng/mL ( 95 % CI : 18.3 , 23.8 ) .
RESULTS	No deaths , serious adverse events , hypoglycemic events , or discontinuations due to adverse events were observed .
CONCLUSIONS	Pharmacokinetics of canagliflozin and its metabolites ( M7 and M5 ) were linear , and no time-dependent changes were observed after single - and multiple-dose administration .
CONCLUSIONS	Similarly , pharmacodynamic effects of canagliflozin on RTG and UGE were found to be dose - and concentration-dependent .
CONCLUSIONS	Overall , canagliflozin was well-tolerated in healthy participants .

###25668196
BACKGROUND	Neuroendocrine and immune stresses imposed by chronic sleep restriction are known to be involved in the harmful cardiovascular effects associated with poor sleep .
OBJECTIVE	Despite a well-known beneficial effect of napping on alertness , its effects on neuroendocrine stress and immune responses after sleep restriction are largely unknown .
METHODS	This study was a strictly controlled ( sleep-wake status , light environment , caloric intake ) , crossover , randomized design in continuously polysomnography-monitored subjects .
METHODS	The study was conducted in a laboratory-based study .
METHODS	The subjects were 11 healthy young men .
METHODS	We investigated the effects on neuroendocrine and immune biomarkers of a night of sleep restricted to 2 h followed by a day without naps or with 30 minute morning and afternoon naps , both conditions followed by an ad libitum recovery night starting at 20:00 .
METHODS	Salivary interleukin-6 and urinary catecholamines were assessed throughout the daytime study periods .
RESULTS	The increase in norepinephrine values seen at the end of the afternoon after the sleep-restricted night was not present when the subjects had the opportunity to take naps .
RESULTS	Interleukin-6 changes observed after sleep deprivation were also normalized after napping .
RESULTS	During the recovery day in the no-nap condition , there were increased levels of afternoon epinephrine and dopamine , which was not the case in the nap condition .
RESULTS	A recovery night after napping was associated with a reduced amount of slow-wave sleep compared to after the no-nap condition .
CONCLUSIONS	Our data suggest that napping has stress-releasing and immune effects .
CONCLUSIONS	Napping could be easily applied in real settings as a countermeasure to the detrimental health consequences of sleep debt .

###24786514
OBJECTIVE	Prior research has indicated that the loss of skeletal muscle mass and bone mineral density observed with aging is related to the prominent age-related decline in the concentration of serum growth hormone ( GH ) .
OBJECTIVE	However , there is limited data on the effects of aging on GH responses to acute bouts of heavy resistance exercise ( HRE ) and aerobic exercise ( AE ) .
METHODS	The present investigation examined the effects of a HRE protocol and an AE protocol on immunoreactive GH ( IGH ) and bioactive GH ( BGH ) in active young and old women .
RESULTS	Older women had a diminished serum IGH response to both the HRE and AE protocols compared to the younger women , however a similar response was not observed in serum BGH .
RESULTS	Additionally , the HRE protocol elicited a greater BGH response than the AE protocol exclusively in the younger group .
CONCLUSIONS	Regardless of exercise mode , aging induces an increase in growth hormone polymerization that specifically results in a loss of serum growth hormone immunoreactivity without a concurrent loss of serum growth hormone bioactivity .
CONCLUSIONS	The greater BGH response to the HRE protocol found in the younger group can be attributed to an unknown serum factor of molecular weight between 30 and 55kD that either potentiated growth hormone bioactivity in response to HRE or inhibited growth hormone bioactivity in response to AE .

###25070961
OBJECTIVE	Behavioral measures are often used to distinguish subgroups of patients with stroke ( eg , to predict treatment gains , stratify clinical trial enrollees , or select rehabilitation therapy ) .
OBJECTIVE	In studies of the upper extremity , measures of brain function using functional magnetic resonance imaging ( fMRI ) have also been found useful , but this approach has not been examined for the lower extremity .
OBJECTIVE	The current study hypothesized that an fMRI-based measure of cortical function would significantly improve prediction of treatment-induced lower extremity behavioral gains .
OBJECTIVE	Biomarkers of treatment gains were also explored .
METHODS	Patients with hemiparesis 1 to 12 months after stroke were enrolled in a double-blind , placebo-controlled , randomized clinical trial of ropinirole + physical therapy versus placebo + physical therapy , results of which have previously been reported ( NCT00221390 ) .
METHODS	( 15 ) Primary end point was change in gait velocity .
METHODS	Enrollees underwent baseline multimodal assessment that included 19 measures spanning 5 assessment categories ( medical history , impairment , disability , brain injury , and brain function ) , and also underwent reassessment 3 weeks after end of therapy .
RESULTS	In bivariate analysis , 8 baseline measures belonging to 4 categories ( medical history , impairment , disability , and brain function ) significantly predicted change in gait velocity .
RESULTS	Prediction was strongest , however , using a multivariate model containing 2 measures ( leg Fugl-Meyer score and fMRI activation volume within ipsilesional foot sensorimotor cortex ) .
RESULTS	Increased activation volume within bilateral foot primary sensorimotor cortex correlated positively with treatment-induced leg motor gains .
CONCLUSIONS	A multimodal model incorporating behavioral and fMRI measures best predicted treatment-induced changes in gait velocity in a clinical trial setting .
CONCLUSIONS	Results also suggest potential use of fMRI measures as biomarkers of treatment gains .

###25439432
OBJECTIVE	To investigate the effect of overnight orthokeratology ( OK ) contact lens wear on axial length growth in East Asian children with progressive myopia .
METHODS	A prospective , randomized , contralateral-eye crossover study conducted over a 1-year period .
METHODS	We enrolled 26 myopic children ( age range , 10.8-17 .0 years ) of East Asian ethnicity .
METHODS	Subjects were fitted with overnight OK in 1 eye , chosen at random , and conventional rigid gas-permeable ( GP ) lenses for daytime wear in the contralateral eye .
METHODS	Lenses were worn for 6 months .
METHODS	After a 2-week recovery period without lens wear , lens-eye combinations were reversed and lens wear was continued for a further 6 months , followed by another 2-week recovery period without lens wear .
METHODS	Axial eye length was monitored at baseline and every 3 months using an IOLMaster biometer .
METHODS	Corneal topography ( Medmont E300 ) and objective refraction ( Shin-Nippon NVision-K 5001 autorefractor ) were also measured to confirm that OK lens wear was efficacious in correcting myopia .
METHODS	Axial length elongation and myopia progression with OK were compared with conventional daytime rigid contact lens wear .
RESULTS	After 6 months of lens wear , axial length had increased by 0.040.06 mm ( meanstandard deviation ) in the GP eye ( P = 0.011 ) but showed no change ( -0.020.05 mm ) in the OK eye ( P = 0.888 ) .
RESULTS	During the second 6-month phase of lens wear , in the OK eye there was no change from baseline in axial length at 12 months ( -0.040.08 mm ; P = 0.218 ) .
RESULTS	However , in the GP eye , the 12-month increase in axial length was significant ( 0.090.09 mm ; P < 0.001 ) .
RESULTS	The GP lens-wearing eye showed progressive axial length growth throughout the study .
CONCLUSIONS	These results provide evidence that , at least in the initial months of lens wear , overnight OK inhibits axial eye growth and myopia progression compared with conventional GP lenses .
CONCLUSIONS	Apparent shortening of axial length early in OK lens wear may reflect the contribution of OK-induced central corneal thinning , combined with choroidal thickening or recovery due to a reduction or neutralization of the myopiogenic stimulus to eye growth in these myopic children .

###25403813
BACKGROUND	Obsessive-compulsive disorder ( OCD ) is a very disabling condition with a chronic course , if left untreated .
BACKGROUND	Though cognitive behavioral treatment ( CBT ) with or without selective serotonin reuptake inhibitors ( SSRI ) is the method of choice , up to one third of individuals with obsessive-compulsive disorder ( OCD ) do not respond to treatment in terms of at least 35 % improvement of symptoms .
BACKGROUND	Mindfulness based cognitive therapy ( MBCT ) is an 8-week group program that could help OCD patients with no or only partial response to CBT to reduce OC symptoms and develop a helpful attitude towards obsessions and compulsive urges .
METHODS	This study is a prospective , bicentric , assessor-blinded , randomized , actively-controlled clinical trial .
METHODS	128 patients with primary diagnosis of OCD according to DSM-IV and no or only partial response to CBT will be recruited from in - and outpatient services as well as online forums and the media .
METHODS	Patients will be randomized to either an MBCT intervention group or to a psycho-educative coaching group ( OCD-EP ) as an active control condition .
METHODS	All participants will undergo eight weekly sessions with a length of 120 minutes each of a structured group program .
METHODS	We hypothesize that MBCT will be superior to OCD-EP in reducing obsessive-compulsive symptoms as measured by the Yale-Brown-Obsessive-Compulsive Scale ( Y-BOCS ) following the intervention and at 6 - and 12-months-follow-up .
METHODS	Secondary outcome measures include depressive symptoms , quality of life , metacognitive beliefs , self-compassion , mindful awareness and approach-avoidance tendencies as measured by an approach avoidance task .
CONCLUSIONS	The results of this study will elucidate the benefits of MBCT for OCD patients who did not sufficiently benefit from CBT .
CONCLUSIONS	To our knowledge , this is the first randomized controlled study assessing the effects of MBCT on symptom severity and associated parameters in OCD .
BACKGROUND	German Clinical Trials Register DRKS00004525 .
BACKGROUND	Registered 19 March 2013 .

###24719063
BACKGROUND	Blond and white hair removal by laser is a complicated task with weak satisfactory results due to the deficiency in laser-absorbing chromophore .
OBJECTIVE	To investigate if repetitive sessions of photodynamic therapy ( PDT ) using external application of liposomal Rose bengal ( RB ) photosensitizer followed by intense pulsed light ( IPL ) exposure enables removal of gray and white hair .
METHODS	Rose bengal loaded in liposomes ( LRB ) was constructed , prepared in hydrogel , and was studied for some pharmaceutical properties .
METHODS	Penetration and selective hair follicle damage in mice skin were studied .
METHODS	Topical gel containing LRB was used for treating fifteen adult females who were complaining of facial white terminal hair .
METHODS	Unwanted facial hair was treated for three sessions at intervals of 4-6 weeks using intense pulsed light ( IPL ) .
METHODS	At each session , the treatment area was pre-treated with topical LRB gel , while a control group of another 15 patients applied placebo gel before IPL treatment .
METHODS	Evaluations included hair regrowth , which was measured 4 weeks after each treatment session and at 6 months follow-up by counting the number of terminal hair compared with baseline pretreatment values .
METHODS	Treatment outcomes and complications if any were also reported .
RESULTS	Average hair regrowth in the LRB group was 56 % after 3 treatment cycles .
RESULTS	After six-months follow up , average terminal hair count compared with baseline pretreatment showed 40 % reduction and no recorded side effects .
RESULTS	A significant difference ( P < 0.05 ) was seen compared with the control group ; the clinical results were promising .
CONCLUSIONS	Photodynamic hair removal using rose bengal-encapsulated liposomal gel in combination with IPL treatment showed significant efficacy in the treatment of white hair compared with a control group .

###26203761
BACKGROUND	Limited data describe patient-reported outcomes ( PROs ) of localised oesophageal cancer treated with definitive chemoradiotherapy ( CRT ) .
BACKGROUND	The phase 2/3 SCOPE-1 trial assessed the effectiveness of CRTcetuximab .
BACKGROUND	The trial for the first time provided an opportunity to describe PROs from a multi-centre group of patients treated with CRT that are presented here .
METHODS	Patients undergoing CRTcetuximab within the SCOPE-1 trial ( 258 patients from 36 UK centres ) completed generic - , disease - and treatment-specific health-related quality of life ( HRQL ) questionnaires ( EORTC QLQ-C30 , QLQ-OES18 , Dermatology Life-Quality Index ( DLQI ) ) at baseline and at 7 , 13 , 24 , 52 and 104 weeks .
METHODS	Mean EORTC functional scale scores ( > 15 point change significant ) , DLQI scores ( > 4 point change significant ) and proportions of patients ( > 15 % significant ) with ` minimal ' or ` severe ' symptoms are presented .
RESULTS	Questionnaire response rates were good .
RESULTS	At baseline , EORTC functional scores were high ( > 75 % ) and few symptoms were reported except for severe problems with fatigue , insomnia and eating-related symptoms ( e.g. , appetite loss , dysphagia , dry mouth ) in both groups ( > 15 % ) .
RESULTS	Functional aspects of health deteriorated and symptoms increased with treatment and by week 13 global quality of life , physical , role and social function significantly deteriorated and more problems with fatigue , dyspnoea , appetite loss and trouble with taste were reported .
RESULTS	Recovery occurred by 6 months ( except severe fatigue and insomnia in > 15 % of patients ) and maintained at follow-up with no differences between groups .
CONCLUSIONS	CRT for localised oesophageal cancer has a significant detrimental impact on many aspects of HRQL ; however , recovery is achieved by 6 months and maintained with the exception of persisting problems with severe fatigue and insomnia .
CONCLUSIONS	The data suggest that the HRQL recovery after definitive CRT is quicker , and there is little lasting deficit compared with treatment including surgery .
CONCLUSIONS	These data need to be compared with HRQL data from studies evaluating treatments including surgery for oesophageal cancer .

###24562803
OBJECTIVE	Ischemic heart disease is a leading worldwide cause of death .
OBJECTIVE	The Seattle Post Myocardial Infarction Model ( SPIM ) was developed to predict survival 6 months to 2 years after an acute myocardial infarction with evidence of left ventricular dysfunction .
RESULTS	A total of 6632 subjects from the EPHESUS trial were used to derive the predictive model , while 5477 subjects from the OPTIMAAL trial were used to validate the model .
RESULTS	Cox proportional hazards modeling was used to develop a multivariate risk score predictive of all-cause mortality .
RESULTS	The SPIM risk score integrated lab and vital parameters , Killip class , reperfusion or revascularization , the number of cardiac evidence-based medicines ( aspirin , statin , blocker , ACEI/ARB , aldosterone blocker ) , and the number of cardiac risk factors .
RESULTS	The model was predictive of all-cause mortality after myocardial infarction , with an AUC of 0.75 at 6 months and 0.75 at 2 years in the derivation cohort and 0.77 and 0.78 for the same time points in the validation cohort .
RESULTS	Model predicted versus Kaplan-Meier observed survival was excellent in the derivation cohort .
RESULTS	It remained so in the validation cohort -- 84.9 % versus 85.0 % at 2 years .
RESULTS	The 10 % of subjects with the highest predicted risk had approximately 25 times higher mortality at 2 years than the 10 % of subjects with the lowest predicted risk .
CONCLUSIONS	The SPIM score was a powerful predictor of outcomes after myocardial infarction with left ventricular dysfunction .
CONCLUSIONS	Its highly accurate predictions should improve patient and physician understanding of survival and may prove a useful tool in post-infarct risk stratification .

###25733274
OBJECTIVE	To evaluate the effect of finasteride on serum androst-4-ene-3 ,17 - dione ( androstenedione ) and its association with prostate cancer risk among subjects who participated in the Prostate Cancer Prevention Trial .
METHODS	We analyzed serum androstenedione levels in 317 prostate cancer cases and 353 controls , nested in the Prostate Cancer Prevention Trial , a randomized placebo-controlled trial that found finasteride decreased prostate cancer risk .
METHODS	Androstenedione is the second most important circulating androgen in men besides testosterone and also a substrate for 5-reductase enzyme .
RESULTS	We observed a 22 % increase in androstenedione levels compared with the baseline values in subjects who were treated with finasteride for 3 years .
RESULTS	This significant increase did not vary by case-control status .
RESULTS	Adjusted odds ratio and 95 % confidence interval for the third tertile of absolute change in androstenedione levels compared with the first tertile were 0.42 ( 95 % confidence interval , 0.19-0 .94 ) for low-grade ( Gleason score < 7 ) cases .
RESULTS	Similar results were observed when analyzed using percent change .
RESULTS	There were no significant associations between serum androstenedione levels and the risk of high-grade disease .
CONCLUSIONS	The results of this nested case-control study confirm that finasteride blocks the conversion of testosterone to dihydrotestosterone ( DHT ) and of androstenedione to 5-androstanedione-3 ,17 - dione , which also leads to the reduction of DHT formation .
CONCLUSIONS	This decrease in DHT may help reduce the risk of low-grade prostate cancer in men .
CONCLUSIONS	Our data on a differential effect of androstenedione also suggest that some high-grade prostate cancers may not require androgen for progression .

###24557425
OBJECTIVE	Vasopressin and corticosteroids are both commonly used adjunctive therapies in septic shock .
OBJECTIVE	Retrospective analyses have suggested that there may be an interaction between these drugs , with higher circulating vasopressin levels and improved outcomes in patients treated with both vasopressin and corticosteroids .
OBJECTIVE	We aimed to test for an interaction between vasopressin and corticosteroids in septic shock .
METHODS	Prospective open-label randomized controlled pilot trial .
METHODS	Four adult ICUs in London teaching hospitals .
METHODS	Sixty-one adult patients who had septic shock .
METHODS	Initial vasopressin IV infusion titrated up to 0.06 U/min and then IV hydrocortisone ( 50 mg 6 hourly ) or placebo .
METHODS	Plasma vasopressin levels were measured at 6-12 and 24-36 hours after hydrocortisone/placebo administration .
RESULTS	Thirty-one patients were allocated to vasopressin + hydrocortisone and 30 patients to vasopressin + placebo .
RESULTS	The hydrocortisone group required a shorter duration of vasopressin therapy ( 3.1 d ; 95 % CI , 1.1-5 .1 ; shorter in hydrocortisone group ) and required a lower total dose of vasopressin ( ratio , 0.47 ; 95 % CI , 0.32-0 .71 ) compared with the placebo group .
RESULTS	Plasma vasopressin levels were not higher in the hydrocortisone group compared with the placebo group ( 64 pmol/L difference at 6 - to 12-hour time point ; 95 % CI , -32 to 160 pmol/L ) .
RESULTS	Early vasopressin use was well tolerated with only one serious adverse event possibly related to study drug administration reported .
RESULTS	There were no differences in mortality rates ( 23 % 28-day mortality in both groups ) or organ failure assessments between the two treatment groups .
CONCLUSIONS	Hydrocortisone spared vasopressin requirements , reduced duration , and reduced dose , when used together in the treatment of septic shock , but it did not alter plasma vasopressin levels .
CONCLUSIONS	Further trials are needed to assess the clinical effectiveness of vasopressin as the initial vasopressor therapy with or without corticosteroids .

###24490842
BACKGROUND	Current holistic rehabilitation blends both physical and psychological techniques .
BACKGROUND	However , validation of the usefulness of psychological strategies is limited in the literature .
OBJECTIVE	To quantify the effects of psychological strategies on both physiologic ( salivary cortisol ) and subjective assessments of stress .
METHODS	Randomized controlled clinical trial .
METHODS	Laboratory .
METHODS	A total of 97 college-aged students ( age = 20.65 4.38 years ) , most with little to no experience with psychological strategies .
METHODS	A 15-minute script via an iPod led the participant through visual imagery ( cognitive relaxation ) or deep breathing exercises ( somatic relaxation ) cues .
METHODS	The control group listened to 15 minutes of ambient nature sounds .
METHODS	Two samples ( pretest , posttest ) of salivary cortisol were analyzed using an enzyme immunoassay kit ; the average was used for statistical analysis .
METHODS	Descriptive statistics and correlations were conducted to examine group differences in time of day , salivary cortisol , sex , Stress-O-Meter values , and Perceived Stress Scale scores .
RESULTS	Salivary cortisol levels were lower in the treatment group than the control group ( F2 ,97 = 15.62 , P < .001 ) .
RESULTS	Females had higher scores on both the pretest Stress-O-Meter ( 5.15 1.796 ) and the Perceived Stress Scale ( 18.31 5.833 ) than males ( 4.25 1.741 and 15.272 5.390 , respectively ) .
CONCLUSIONS	Both cognitive and somatic relaxation strategies reduced cortisol levels .
CONCLUSIONS	Participants who received verbal guidance achieved a larger cortisol reduction .
CONCLUSIONS	However , the change in cortisol level was uncorrelated with the change in report of acute stress ; females reported higher levels of stress .
CONCLUSIONS	Clinical implications include attention to sex when assessing stress and providing coping skills during the rehabilitation process .

###24568472
OBJECTIVE	To explore the efficiency of single application of lobaplatin in tran-scatheter arterial chemoembolization ( TACE ) for patients with a primary hepatic carcinoma who were unable or unwilling to undergo surgery .
METHODS	173 patients with primary hepatic carcinoma diagnosed by imaging or pathology were randomly divided into experimental and control groups and respectively treated with lobaplatin and pirarubicin hydrochloride as chemotherapeutic drugs for TACE .
METHODS	The amount of iodipin was regulated according to the tumor number and size , and then gelatin sponge or polyvinyl alcohol particles were applied for embolisms .
METHODS	The efficiency of treatment in the two groups was compared with reference to survival time and therapeutic response .
RESULTS	The experimental group ( single lobaplatin as chemotherapy drug ) was superior to control group ( single pirarubicin hydrochloride as chemotherapy drug ) in the aspects of survival time and therapeutic response , with statistical significance .
CONCLUSIONS	Single lobaplatin can be as a chemotherapy drug in TACE and has better efficiency in the aspects of mean survival time and therapeutic response , deserving to be popularized in the clinic .

###24343389
OBJECTIVE	The primary objective of this study was to compare Aquacel ( ConvaTec , Skillman , New Jersey ) , Allevyn ( Smith & Nephew , St Petersburg , Florida ) , and Mediskin I ( Mlnlycke , Health Care AB , Gothenburg , Sweden ) in the treatment of split-thickness skin graft donor sites .
METHODS	This study was performed as a prospective randomized , 3-arm , clinical study .
METHODS	A clinical study performed at a hand and plastic surgery department with burn unit .
METHODS	The study included 67 adults with a total of 73 donor sites , which were on the thigh , not reharvested , and ranged between 30 - and 400-cm area .
METHODS	Subjects were randomly assigned to treatment with Aquacel , Allevyn , or Mediskin I.
METHODS	The donor site was assessed on postoperative days 3 , 14 , and 21 for healing , infection , pain , impact on everyday life , ease of use , and cost .
RESULTS	The obtained results demonstrate significantly faster re-epithelialization for patients treated with Aquacel or Mediskin I compared with Allevyn .
RESULTS	Regarding infections , there were no significant differences between the groups .
RESULTS	Patients wearing Aquacel experienced significantly less pain changing the dressing and less impact on everyday life than the patients wearing Allevyn .
RESULTS	Aquacel was shown to be significantly easier for the caregiver to use than Allevyn and Mediskin I.
RESULTS	There is a significant difference in cost of treatment between the dressings , whereas Mediskin I is the most expensive .
CONCLUSIONS	The authors ' results support the use of Aquacel in the treatment of split-thickness skin graft donor sites .
CONCLUSIONS	Aquacel has a low cost per unit , is user friendly , gives short healing time , and minimizes patient discomfort .

###25134636
BACKGROUND	There is a higher prevalence of obesity in individuals with mental disorders compared to the general population .
BACKGROUND	The results of several studies suggested that weight reduction in this population is possible following psycho-educational and/or behavioural weight management interventions .
BACKGROUND	Evidence of the effectiveness alone is however inadequate for policy making .
BACKGROUND	The aim of the current study was to evaluate the cost-effectiveness of a health promotion intervention targeting physical activity and healthy eating in individuals with mental disorders .
METHODS	A Markov decision-analytic model using a public payer perspective was applied , projecting the one-year results of a 10-week intervention over a time horizon of 20 years , assuming a repeated yearly implementation of the programme .
METHODS	Scenario analysis was applied evaluating the effects on the results of alternative modelling assumptions .
METHODS	One-way sensitivity analysis was performed to assess the effects on the results of varying key input parameters .
RESULTS	An incremental cost-effectiveness ratio of 27,096 / quality-adjusted life years ( QALY ) in men , and 40,139 / QALY in women was found in the base case .
RESULTS	Scenario analysis assuming an increase in health-related quality of life as a result of the body mass index decrease resulted in much better cost-effectiveness in both men ( 3,357 / QALY ) and women ( 3,766 / QALY ) .
RESULTS	The uncertainty associated with the intervention effect had the greatest impact on the model .
CONCLUSIONS	As far as is known to the authors , this is the first health economic evaluation of a health promotion intervention targeting physical activity and healthy eating in individuals with mental disorders .
CONCLUSIONS	Such research is important as it provides payers and governments with better insights how to spend the available resources in the most efficient way .
CONCLUSIONS	Further research examining the cost-effectiveness of health promotion targeting physical activity and healthy eating in individuals with mental disorders is required .

###24879552
OBJECTIVE	The aim of this study was to investigate the effects of shock wave therapy on gait pattern in children with hemiplegic cerebral palsy .
METHODS	Fifteen children were assigned to the study group , whose members received shock wave therapy ( 1500 shots/muscle , frequency of 5Hz , energy of 0.030 mJ/mm , one session/wk ) .
METHODS	Another 15 were assigned to the control group , whose members participated in a conventional physical therapy exercise program for 3 successive months .
METHODS	Baseline and posttreatment assessments were performed using the Modified Ashworth Scale to evaluate spasticity degrees and using a three-dimensional gait analysis to evaluate gait parameters .
RESULTS	Children in the study group showed a significant improvement when compared with those in the control group ( P < 0.005 ) .
RESULTS	The Modified Ashworth scores after treatment were 1.86 ( 0.22 ) and 1.63 ( 0.23 ) for the control and study groups , respectively .
RESULTS	The gait parameters ( stride length , cadence , speed , cycle time , and stance phase percentage ) after treatment were 0.5 m , 125 steps/min , 0.6 m/sec , 0.48 sec , and 50.4 % and 0.74 m , 119 steps/min , 0.75 m/sec , 0.65 sec , and 55.9 % for the control group and the study group , respectively .
CONCLUSIONS	Shock wave therapy may be a useful tool for improving spasticity and gait pattern in children with hemiplegic cerebral palsy .

###24757132
OBJECTIVE	To develop and validate composite disease activity scores , based on widely available clinical measures , that would demonstrate improved correlation with detection of synovitis on magnetic resonance imaging ( MRI ) and radiographic progression , in comparison with conventional measures , in patients with rheumatoid arthritis ( RA ) .
METHODS	This study was conducted as a secondary study of 2 RA clinical trials , GO-BEFORE ( development cohort ) and GO-FORWARD ( validation cohort ) .
METHODS	Generalized estimating equations were used to evaluate independent cross-sectional associations of component variables ( from all time points ) with concurrent MRI measures of synovitis and bone edema in the development cohort .
METHODS	Based on regression coefficients , modified versions of the Disease Activity Score in 28 joints ( M-DAS28 ) , Simplified Disease Activity Index ( M-SDAI ) , and Clinical Disease Activity Index ( M-CDAI ) were generated for each subject in the validation cohort .
METHODS	The M-DAS28 , M-SDAI , and M-CDAI scores were compared to conventional scores of disease activity with regard to associations with MRI measures of synovitis and radiographic progression , assessed using Pearson 's and Spearman 's correlations , linear/logistic regression , and receiver operating characteristic analysis .
RESULTS	Four variables were independently associated with MRI-detected synovitis and bone edema in the development cohort : C-reactive protein ( CRP ) level , erythrocyte sedimentation rate ( ESR ) , swollen joint count in 28 joints ( SJC28 ) , and evaluator 's global assessment of disease activity using a visual analog scale ( EvGA score ) .
RESULTS	Modified disease activity scores were generated using the regression coefficients obtained in the synovitis models for all subjects in the validation cohort ; modified scores were calculated as M-DAS28 = 0.49 ln ( CRP ) + 0.15 SJC28 + 0.22 EvGA + 1 and M-SDAI = CRP + SJC28 + EvGA .
RESULTS	Both modified and conventional disease activity scores correlated significantly with MRI measures of synovitis .
RESULTS	Modified scores showed superior correlation with synovitis , as compared to conventional scores , at all time points ( P < 0.05 ) .
RESULTS	Furthermore , the M-DAS28 and M-SDAI had superior test characteristics for prediction of radiographic progression at 52 weeks ( both P < 0.05 ) .
CONCLUSIONS	Modified disease activity scores demonstrated superior correlation with MRI detection of synovitis at all time points , and more accurately predicted radiographic progression in patients with RA in a clinical trial setting .

###24494285
OBJECTIVE	To observe the efficacy in cervical headache of acupuncture combined with fire needling and the simple acupuncture therapy .
METHODS	One hundred and eighty cases were randomized into an acupuncture plus fire needling group ( group A ) and an acupuncture group ( group B ) , 90 cases in each one .
METHODS	Baihui ( GV 20 ) , Wangu ( GB 12 ) , Fengchi ( GB 20 ) , Tianzhu ( BL 10 ) and Neck-Jiaji ( EX-B 2 ) were selected in the two groups .
METHODS	In group A , the fire needling technique was applied to all the above points before acupuncture with filiform needles .
METHODS	In group B , the acupuncture therapy was used only .
METHODS	The treatment was given once a day , the efficacy was compared between the two groups after 20 treatments .
RESULTS	The total effective rate was 95.6 % ( 86/90 ) in group A and was 84.4 % ( 76/90 ) in group B , indicating the significant difference in comparison ( P < 0.05 ) .
RESULTS	VAS were 7.44 + / -1.26 and 0.73 + / - l. 44 before and after treatment in group A separately , those were 7.56 + / -1.07 and 2.56 + / -2.99 in group B , indicating the significant difference in comparison ( P < 0.01 ) .
RESULTS	The difference in VAS after treatment was significant between the two groups .
RESULTS	In group A , the follow-up visit was conducted at 3 months and 6 months after treatment for the cured cases .
RESULTS	The total recurrence rate in the patients without bony pathological changes was 14.8 % ( 4/27 ) and that in the patients with bony pathological changes was 43.5 % ( 10/23 ) , there was significant difference between them ( P < 0.05 ) .
CONCLUSIONS	The combined therapy of fire needling technique and filiform needle acupuncture improves the efficacy and sustains the efficacy especially on cervical headache without bony pathological changing .

###24754313
BACKGROUND	Liver-selective thyromimetic agents could provide a new approach for treating dyslipidaemia .
METHODS	We performed a multicentre , randomized , placebo-controlled , double-blind study to evaluate the efficacy and safety of eprotirome , a liver-selective thyroid hormone receptor agonist , in 98 patients with primary hypercholesterolaemia .
METHODS	After previous drug wash-out and dietary run-in , patients received 100 or 200 g day ( -1 ) eprotirome or placebo for 12 weeks .
METHODS	The primary end-point was change in serum LDL cholesterol ; secondary end-points included changes in other lipid parameters and safety measures .
RESULTS	Eprotirome treatment at 100 and 200 g daily reduced serum LDL cholesterol levels by 23 5 % and 31 4 % , respectively , compared with 2 6 % for placebo ( P < 0.0001 ) .
RESULTS	Similar reductions were seen in non-HDL cholesterol and apolipoprotein ( apo ) B , whereas serum levels of HDL cholesterol and apo A-I were unchanged .
RESULTS	There were also considerable reductions in serum triglycerides and lipoprotein ( a ) , in particular in patients with elevated levels at baseline .
RESULTS	There was no evidence of adverse effects on heart or bone and no changes in serum thyrotropin or triiodothyronine , although the thyroxine level decreased .
RESULTS	Low-grade increases in liver enzymes were evident in most patients .
CONCLUSIONS	In hypercholesterolaemic patients , the liver-selective thyromimetic eprotirome decreased serum levels of atherogenic lipoproteins without signs of extra-hepatic side effects .
CONCLUSIONS	Selective stimulation of hepatic thyroid hormone receptors may be an attractive way to modulate lipid metabolism in hyperlipidaemia .

###25066449
BACKGROUND	Impulsive decision making is a hallmark of frequently occurring addiction disorders including alcohol dependence ( AD ) .
BACKGROUND	Therefore , ameliorating impulsive decision making is a promising target for the treatment of AD .
BACKGROUND	Previous studies have shown that modafinil enhances cognitive control functions in various psychiatric disorders .
BACKGROUND	However , the effects of modafinil on delay discounting and its underlying neural correlates have not been investigated as yet .
BACKGROUND	The aim of the current study was to investigate the effects of modafinil on neural correlates of impulsive decision making in abstinent AD patients and healthy control ( HC ) subjects .
METHODS	A randomized , double-blind , placebo-controlled , within-subjects cross-over study using functional magnetic resonance imaging ( fMRI ) was conducted in 14 AD patients and 16 HC subjects .
METHODS	All subjects participated in two fMRI sessions in which they either received a single dose of placebo or 200mg of modafinil 2h before the session .
METHODS	During fMRI , subjects completed a delay-discounting task to measure impulsive decision making .
RESULTS	Modafinil improved impulsive decision making in AD pateints , which was accompanied by enhanced recruitment of frontoparietal regions and reduced activation of the ventromedial prefrontal cortex .
RESULTS	Moreover , modafinil-induced enhancement of functional connectivity between the superior frontal gyrus and ventral striatum was specifically associated with improvement in impulsive decision making .
CONCLUSIONS	These findings indicate that modafinil can improve impulsive decision making in AD patients through an enhanced coupling of prefrontal control regions and brain regions coding the subjective value of rewards .
CONCLUSIONS	Therefore , the current study supports the implementation of modafinil in future clinical trials for AD .

###25802346
OBJECTIVE	Although many attention-deficit/hyperactivity disorder ( ADHD ) care models have been studied , few have demonstrated individual-level symptom improvement .
OBJECTIVE	We sought to test whether complementing basic collaborative care with interventions that address common reasons for symptom persistence improves outcomes for children with inattention and hyperactivity/impulsivity .
METHODS	We conducted a randomized comparative effectiveness trial of 2 care management systems for 6 - to 12-year-old children being evaluated for ADHD ( n = 156 ) .
METHODS	All participants received care management with decision support .
METHODS	Care managers in the enhanced care arm also were trained in motivational and parent management techniques to help parents engage in their child 's treatment , address their own mental health needs , and manage challenging child behaviors .
METHODS	We used multivariable models to assess inattention , hyperactivity/impulsivity , oppositionality , and social skills over 1 year .
RESULTS	Both treatment arms generated guideline concordant diagnostic processes in 94 % of cases ; 40 % of children had presentations consistent with ADHD .
RESULTS	For the entire sample , there were no differences in symptom trajectories between study arms ; mean differences in change scores at 12 months were -0.14 ( 95 % confidence interval -0.34 to 0.07 ) for inattention ; -0.13 ( -0.31 to 0.05 ) for hyperactivity/impulsivity ; -0.09 ( -0.28 to 0.11 ) for oppositionality ; and 3.30 ( -1.23 to 7.82 ) for social skills .
RESULTS	Among children with ADHD-consistent presentations , enhanced arm participants experienced superior change scores for hyperactivity/impulsivity of -0.36 ( -0.69 to -0.03 ) , oppositionality -0.40 ( -0.75 to -0.05 ) , and social skills 9.57 ( 1.85 to 17.28 ) .
CONCLUSIONS	Among children with ADHD-consistent presentations , addressing barriers to engagement with care and challenging child behaviors has potential to improve the effectiveness of collaborative care .

###24641624
BACKGROUND	Fish oil supplementation has been shown to alter gene expression of mononuclear cells both in vitro and in vivo .
BACKGROUND	However , little is known about the total transcriptome profile in healthy subjects after intake of fish oil .
BACKGROUND	We therefore investigated the gene expression profile in peripheral blood mononuclear cells ( PBMCs ) after intake of fish oil for 7 weeks using transcriptome analyses .
METHODS	In a 7-week , double-blinded , randomized , controlled , parallel-group study , healthy subjects received 8 g day ( -1 ) fish oil ( 1.6 g day ( -1 ) eicosapentaenoic acid + docosahexaenoic acid ) ( n = 17 ) or 8 g day ( -1 ) high oleic sunflower oil ( n = 19 ) .
METHODS	Microarray analyses of RNA isolated from PBMCs were performed at baseline and after 7 weeks of intervention .
RESULTS	Cell cycle , DNA packaging and chromosome organization are biological processes found to be upregulated after intake of fish oil compared to high oleic sunflower oil using a moderated t-test .
RESULTS	In addition , gene set enrichment analysis identified several enriched gene sets after intake of fish oil .
RESULTS	The genes contributing to the significantly different gene sets in the subjects given fish oil compared with the control group are involved in cell cycle , endoplasmic reticulum ( ER ) stress and apoptosis .
RESULTS	Gene transcripts with common motifs for 35 known transcription factors including E2F , TP53 and ATF4 were upregulated after intake of fish oil .
CONCLUSIONS	We have shown that intake of fish oil for 7 weeks modulates gene expression in PBMCs of healthy subjects .
CONCLUSIONS	The increased expression of genes related to cell cycle , ER stress and apoptosis suggests that intake of fish oil may modulate basic cellular processes involved in normal cellular function .

###24875466
OBJECTIVE	Despite increasing trends toward the early initiation of oral feeding after gastrointestinal ( GI ) surgeries , current evidence has not been convincing .
OBJECTIVE	The present randomized clinical trial aimed to compare the clinical outcomes of early oral feeding ( EOF ) with late oral feeding ( LOF ) following surgery for upper GI tumors .
METHODS	One hundred and nine consecutive patients with esophageal or gastric tumors undergoing surgical resection in two hospitals in Tehran , Iran , were enrolled in this prospective randomized controlled trial , and were randomly assigned to a group starting EOF on the first postoperative day and another group that remained nil by mouth until the return of bowel sounds ( LOF group ) .
METHODS	The clinical and surgical outcomes were compared between the two groups .
RESULTS	The clinical outcomes were significantly better in the patients in the EOF group ( p < 0.05 ) .
RESULTS	Repeated nil per os ( 14.8 vs. 30.9 % ) and re-hospitalization ( 1.8 vs. 7.3 % ) were more common in LOF group ( p < 0.0001 ) .
RESULTS	Additionally , gas passage , nasogastric tube ( NGT ) discharge , a decrease in intravenous serum to less than 1000 ml per day , the time to start a soft diet and hospital discharge following surgery occurred significantly earlier in the EOF group than in the LOF group ( p < 0.0001 ) .
CONCLUSIONS	Early oral feeding after the surgical resection of esophageal and gastric tumors is safe , and is associated with favorable early in-hospital outcomes and a sooner return to physiological GI function and hospital discharge .

###24613817
OBJECTIVE	To examine whether socioeconomic position ( SEP ) was associated with change in cardiovascular risk factors and meeting treatment targets for cardiovascular risk factors among individuals with screen-detected Type 2 DM at six-year follow-up .
METHODS	The study population was 1533 people with Type 2 DM identified from at stepwise diabetes screening programme in general practice during 2001-2006 in the ADDITION-Denmark study .
METHODS	The ADDITION-study was performed as a randomised trial but the two randomisation groups were analysed as one cohort in this study .
METHODS	Cardiovascular risk factors were measured at baseline and repeated at follow-up ( mean : 5.9 [ 1.4 ] years ) .
METHODS	Information on SEP , redeemed antihypertensive and lipid-lowering treatment were obtained from Danish registers .
METHODS	Multivariate analyses were performed to estimate change in cardiovascular risk factors and difference in meeting treatment targets .
RESULTS	The change in HbA1c , cholesterol , blood pressure and BMI were virtually the same across educational level , income level , occupational status or cohabiting status .
RESULTS	Overall , the ability to meet treatment targets for HbA1c , cholesterol and blood pressure was not modified by SEP-group .
RESULTS	A higher proportion of people with lower educational level or lower income level in the intensive care redeemed anti-hypertensive treatment compared to people with higher educational or income levels .
CONCLUSIONS	Screen-detection and early treatment onset did not introduce socioeconomic inequality in metabolic control in people with screen-detected Type 2 DM at six-year follow-up .

###25627664
OBJECTIVE	To assess the efficacy of a financial incentive added to routine specialist pregnancy stop smoking services versus routine care to help pregnant smokers quit .
METHODS	Phase II therapeutic exploratory single centre , individually randomised controlled parallel group superiority trial .
METHODS	One large health board area with a materially deprived , inner city population in the west of Scotland , United Kingdom .
METHODS	612 self reported pregnant smokers in NHS Greater Glasgow and Clyde who were English speaking , at least 16 years of age , less than 24 weeks pregnant , and had an exhaled carbon monoxide breath test result of 7 ppm or more .
METHODS	306 women were randomised to incentives and 306 to control .
METHODS	The control group received routine care , which was the offer of a face to face appointment to discuss smoking and cessation and , for those who attended and set a quit date , the offer of free nicotine replacement therapy for 10 weeks provided by pharmacy services , and four , weekly support phone calls .
METHODS	The intervention group received routine care plus the offer of up to 400 of shopping vouchers : 50 for attending a face to face appointment and setting a quit date ; then another 50 if at four weeks ' post-quit date exhaled carbon monoxide confirmed quitting ; a further 100 was provided for continued validated abstinence of exhaled carbon monoxide after 12 weeks ; a final 200 voucher was provided for validated abstinence of exhaled carbon monoxide at 34-38 weeks ' gestation .
METHODS	The primary outcome was cotinine verified cessation at 34-38 weeks ' gestation through saliva ( < 14.2 ng/mL ) or urine ( < 44.7 ng/mL ) .
METHODS	Secondary outcomes included birth weight , engagement , and self reported quit at four weeks .
RESULTS	Recruitment was extended from 12 to 15 months to achieve the target sample size .
RESULTS	Follow-up continued until September 2013 .
RESULTS	Of the 306 women randomised , three controls opted out soon after enrolment ; these women did not want their data to be used , leaving 306 intervention and 303 control group participants in the intention to treat analysis .
RESULTS	No harms of financial incentives were documented .
RESULTS	Significantly more smokers in the incentives group than control group stopped smoking : 69 ( 22.5 % ) versus 26 ( 8.6 % ) .
RESULTS	The relative risk of not smoking at the end of pregnancy was 2.63 ( 95 % confidence interval 1.73 to 4.01 ) P < 0.001 .
RESULTS	The absolute risk difference was 14.0 % ( 95 % confidence interval 8.2 % to 19.7 % ) .
RESULTS	The number needed to treat ( where financial incentives need to be offered to achieve one extra quitter in late pregnancy ) was 7.2 ( 95 % confidence interval 5.1 to 12.2 ) .
RESULTS	The mean birth weight was 3140 g ( SD 600 g ) in the incentives group and 3120 ( SD 590 ) g in the control group ( P = 0.67 ) .
CONCLUSIONS	This phase II randomised controlled trial provides substantial evidence for the efficacy of incentives for smoking cessation in pregnancy ; as this was only a single centre trial , incentives should now be tested in different types of pregnancy cessation services and in different parts of the United Kingdom .
BACKGROUND	Current Controlled Trials ISRCTN87508788 .

###25401512
OBJECTIVE	To compare the efficacy and safety of the intraocular lens ( IOL ) - shell procedure versus conventional phacoemulsification for the surgical treatment of dense cataracts .
METHODS	Eighty eyes with dense nuclear cataracts were enrolled in a prospective , randomized controlled study .
METHODS	Patients were assigned to two groups .
METHODS	In Group I , the IOL was traditionally implanted after all nuclear fragments were completely removed , and in Group II , the IOL was innovatively implanted in the bag before the last residual nuclear fragment was removed .
METHODS	This novel adjusted surgical procedure , named the `` IOL-shell technique '' , features use of the IOL as a protective barrier rather than simply as a refractive alternative , and it is conceptually different from the traditional step-by-step procedure .
METHODS	Clinical examinations , including uncorrected visual acuity , central corneal thickness ( CCT ) , temporal clear corneal incision thickness and corneal endothelial cell density , were carried out .
RESULTS	The inter-group difference in temporal corneal thickness was found to be of no statistical significance at any of the visits .
RESULTS	Compared to eyes in Group I , those in Group II were shown to have significantly less corneal endothelial cell loss on both the 7th and 30th day following surgery .
RESULTS	At 7 days after surgery , the mean corneal endothelial cell loss in Group II was 10.29 % , compared to 14.37 % in Group I ( P < 0.05 ) .
RESULTS	The mean endothelial cell loss measured on postoperative day 30 was 16.88 % in Group II compared to 23.32 % in Group I ( P < 0.05 ) .
RESULTS	On the 1st day after surgery , the mean CCT of eyes in Group II was significantly smaller compared to Group I ( Group I vs. Group II : 19.42 % vs. 13.50 % , P < 0.05 ) .
CONCLUSIONS	Compared to conventional phacoemulsification , the IOL-shell technique was shown to be a relatively safer procedure without compromised efficiency for dense cataracts , and it caused less corneal endothelial cell loss and milder postoperative corneal edema ( Clinical Trials Identifier : NCT02138123 ) .
BACKGROUND	ClinicalTrials.gov NCT02138123 .

###24588965
BACKGROUND	Early prognostication after successful cardiopulmonary resuscitation is difficult , and there is a need for novel methods to estimate the extent of brain injury and predict outcome .
BACKGROUND	In this study , we evaluated the impact of the cardiac arrest syndrome on the plasma levels of selected tissue-specific microRNAs ( miRNAs ) and assessed their ability to prognosticate death and neurological disability .
METHODS	We included 65 patients treated with hypothermia after cardiac arrest in the study .
METHODS	Blood samples were obtained at 24 hours and at 48 hours .
METHODS	For miRNA-screening purposes , custom quantitative polymerase chain reaction ( qPCR ) panels were first used .
METHODS	Thereafter individual miRNAs were assessed at 48 hours with qPCR .
METHODS	miRNAs that successfully predicted prognosis at 48 hours were further analysed at 24 hours .
METHODS	Outcomes were measured according to the Cerebral Performance Category ( CPC ) score at 6 months after cardiac arrest and stratified into good ( CPC score 1 or 2 ) or poor ( CPC scores 3 to 5 ) .
RESULTS	At 48 hours , miR-146a , miR-122 , miR-208b , miR-21 , miR-9 and miR-128 did not differ between the good and poor neurological outcome groups .
RESULTS	In contrast , miR-124 was significantly elevated in patients with poor outcomes compared with those with favourable outcomes ( P < 0.0001 ) at 24 hours and 48 hours after cardiac arrest .
RESULTS	Analysis of receiver operating characteristic curves at 24 and 48 hours after cardiac arrest showed areas under the curve of 0.87 ( 95 % confidence interval ( CI ) = 0.79 to 0.96 ) and 0.89 ( 95 % CI = 0.80 to 0.97 ) , respectively .
CONCLUSIONS	The brain-enriched miRNA miR-124 is a promising novel biomarker for prediction of neurological prognosis following cardiac arrest .

###25117063
OBJECTIVE	We compare attribution and social comparison theories as potential explanations for attitudes towards overweight and underweight targets among Australian university students .
METHODS	185 female students ( median age 18 ) completed a measure of body image state , then read one of six vignettes , describing a female student who was underweight , average weight or overweight , and who did or did not have a medical condition affecting weight .
METHODS	Independent variables were target weight ( underweight , average-weight , overweight ) ; weight controllability ( no information , uncontrollable ) ; and participant body image ( higher , lower ) .
METHODS	Participants evaluated the target on six characteristics derived from existing research on weight bias , on seven-point Likert scales : attractive ; healthy ; likeable ; motivated ; self-disciplined ; having willpower .
RESULTS	A three-way between-participants multivariate analysis of covariance was conducted , with post hoc comparisons of significant effects .
RESULTS	Overweight targets were rated more negatively than average-weight and underweight targets .
RESULTS	Uncontrollability ( medical ) information produced more positive evaluations of the overweight target , but more negative evaluations of the underweight target .
RESULTS	Ratings of the average-weight target were not influenced by uncontrollability information .
RESULTS	Participant body image state had no significant effects .
CONCLUSIONS	Results provided partial support for attribution theory , but not for social comparison theory , as an explanation of weight bias .

###25640706
BACKGROUND	Severe anaemia in children is a leading cause of hospital admission and a major cause of mortality in sub-Saharan Africa , yet there are limited published data on blood transfusion in this vulnerable group .
METHODS	We present data from a large controlled trial of fluid resuscitation ( Fluid Expansion As Supportive Therapy ( FEAST ) trial ) on the prevalence , clinical features , and transfusion management of anaemia in children presenting to hospitals in three East African countries with serious febrile illness ( predominantly malaria and/or sepsis ) and impaired peripheral perfusion .
RESULTS	Of 3,170 children in the FEAST trial , 3,082 ( 97 % ) had baseline haemoglobin ( Hb ) measurement , 2,346 / 3,082 ( 76 % ) were anaemic ( Hb < 10 g/dL ) , and 33 % severely anaemic ( Hb < 5 g/dL ) .
RESULTS	Prevalence of severe anaemia varied from 12 % in Kenya to 41 % in eastern Uganda .
RESULTS	1,387 / 3,082 ( 45 % ) children were transfused ( 81 % within 8 hours ) .
RESULTS	Adherence to WHO transfusion guidelines was poor .
RESULTS	Among severely anaemic children who were not transfused , 52 % ( 54/103 ) died within 8 hours , and 90 % of these deaths occurred within 2.5 hours of randomisation .
RESULTS	By 24 hours , 128/1 ,002 ( 13 % ) severely anaemic children had died , compared to 36/501 ( 7 % ) and 71/843 ( 8 % ) of those with moderate and mild anaemia , respectively .
RESULTS	Among children without severe hypotension who were randomised to receive fluid boluses of 0.9 % saline or albumin , mortality was increased ( 10.6 % and 10.5 % , respectively ) compared to controls ( 7.2 % ) , regardless of admission Hb level .
RESULTS	Repeat transfusion varied from 2 % in Kenya/Tanzania to 6 to 13 % at the four Ugandan centres .
RESULTS	Adverse reactions to blood were rare ( 0.4 % ) .
CONCLUSIONS	Severe anaemia complicates one third of childhood admissions with serious febrile illness to hospitals in East Africa , and is associated with increased mortality .
CONCLUSIONS	A high proportion of deaths occurred within 2.5 hours of admission , emphasizing the need for rapid recognition and prompt blood transfusion .
CONCLUSIONS	Adherence to current WHO transfusion guidelines was poor .
CONCLUSIONS	The high rates of re-transfusion suggest that 20 mL/kg whole blood or 10 mL/kg packed cells may undertreat a significant proportion of anaemic children .
CONCLUSIONS	Future evaluation of the impact of a larger volume of transfused blood and optimum transfusion management of children with Hb of < 6 g/dL is warranted .

###25119563
OBJECTIVE	To assess long-term superiority in terms of chronic pain between prolene hernia system ( PHS ) , mesh plug repair ( MPR ) and Lichtenstein ( L ) technique for inguinal hernia repair .
METHODS	Eight years after randomizing three commonly used techniques for primary inguinal hernia repair , the outcome was evaluated with a questionnaire measuring pain on verbal descriptor and visual analogue scales , including limitations on daily life activities , sensory disturbances and recurrences .
METHODS	From previous results patients characteristics , operative details and short - and mid-term pain outcome were extracted .
RESULTS	270 out of 308 eligible patients ( 88 % ) completed the follow-up after median 7.6 years ( range 6.9-9 .2 ) after the inguinal hernia operation .
RESULTS	No significant differences between the repair techniques were found for pain , sensory disturbances or recurrences .
RESULTS	Overall , the hernia recurrence rate was 6.3 % .
RESULTS	In total 63 patients ( 23 % ) reported long-term pain of which one-fourth graded this moderate to severe .
RESULTS	Pain was experienced at least weekly by 26 patients ( 10 % ) and limiting daily activities for 36 patients ( 13 % ) .
RESULTS	With regard to the previously reported pain at 3 and 15 months follow-up , 106 patients ( 39 % ) experience no pain at all .
RESULTS	For 101 patients ( 37 % ) , initial pain disappeared .
RESULTS	41 patients ( 15 % ) suffered persisting pain at all three measure moments .
RESULTS	22 patients ( 8 % ) reported pain at 8 years follow-up after an initial pain-free period .
CONCLUSIONS	Long-term outcome after randomizing PHS , MPR and L showed no clinically relevant differences in chronic pain and its consequences .
CONCLUSIONS	Although chronic pain is diminishing over time it remains a serious complication and has sometimes an onset long after the inguinal repair .

###26035251
BACKGROUND	Previous work has demonstrated paradoxical increases in cerebral oxygen saturation ( ScO2 ) as blood pressure decreases and paradoxical decreases in ScO2 as blood pressure increases .
BACKGROUND	It has been suggested that these paradoxical responses indicate a functional cerebral autoregulation mechanism .
BACKGROUND	Accordingly , the authors hypothesized that if this suggestion is correct , paradoxical responses will occur exclusively in patients with intact cerebral autoregulation .
METHODS	Thirty-four patients undergoing elective cardiac surgery were included .
METHODS	Cerebral autoregulation was assessed with the near-infrared spectroscopy-derived cerebral oximetry index ( COx ) , computed by calculating the Spearman correlation coefficient between mean arterial pressure and ScO2 .
METHODS	COx less than 0.30 was previously defined as functional autoregulation .
METHODS	During cardiopulmonary bypass , 20 % change in blood pressure was accomplished with the use of nitroprusside for decreasing pressure and phenylephrine for increasing pressure .
METHODS	Effects on COx were assessed .
METHODS	Data were analyzed using two-way ANOVA , Kruskal-Wallis test , and Wilcoxon and Mann-Whitney U test .
RESULTS	Sixty-five percent of patients had a baseline COx less than 0.30 , indicating functional baseline autoregulation .
RESULTS	In 50 % of these patients ( n = 10 ) , COx became highly negative after vasoactive drug administration ( from -0.04 [ -0.25 to 0.16 ] to -0.63 [ -0.83 to -0.26 ] after administration of phenylephrine , and from -0.05 [ -0.19 to 0.17 ] to -0.55 [ -0.94 to -0.35 ] after administration of nitroprusside ) .
RESULTS	A negative COx implies a decrease in ScO2 with increase in pressure and , conversely , an increase in ScO2 with decrease in pressure .
CONCLUSIONS	In this study , paradoxical changes in ScO2 after pharmacological-induced pressure changes occurred exclusively in patients with intact cerebral autoregulation , corroborating the hypothesis that these paradoxical responses might be attributable to a functional cerebral autoregulation .

###24250317
BACKGROUND	In many facilities , drains are routinely inserted after thyroidectomy with the aim of preventing hematoma formation and accumulation of seroma .
BACKGROUND	The continued use of drains may be based more on tradition rather than proven scientific evidence .
OBJECTIVE	To assess the benefit of drain use after thyroidectomy by determining ; length of hospital stay , post operative pain and wound sepsis .
METHODS	This was a randomized controlled trial , carried out at a tertiary national referral hospital ( Mulago , Kampala ) .
METHODS	Over a 6 month period in 2011 , we recruited 68 patients .
METHODS	Socio-demographic information and clinical parameters were recorded .
METHODS	Outcomes measures were evaluated .
METHODS	Data were double entered into epidata version 3.1.1 and analyzed using STATA version 10.0 .
METHODS	Ethical approval was secured .
RESULTS	Mean age of participants was 46 and 43.7 years in drain and no drain arm respectively .
RESULTS	Most participants were female .
RESULTS	Mean duration of hospital stay after thyroidectomy was significantly higher among the drain arm as compared with the no drain arm [ 2.41 ( 0.89 ) vs 1.71 ( 0.76 ) days ( p = 0.0008 ) ] .
RESULTS	One patient ( drain arm ) had wound infection .
RESULTS	The pain score on the postoperative day was statistically higher among in the drain arm than the no drain arm [ 5.71 vs 2.53 ( p = 0.001 ) ] .
CONCLUSIONS	Not inserting a drain post operatively after thyroid surgery was associated with short hospital stay and less operative pain .
CONCLUSIONS	Results of this study do not support routine drainage after thyroid surgery .

###25559589
OBJECTIVE	Despite precise surgical technique , some postoperative facial scars will depress and widen over time , likely due to weakened or inadequately replaced collagen fibers in the underlying dermis .
OBJECTIVE	The purpose of this study is to evaluate whether a 10,600 nm ablative carbon dioxide ( CO2 ) fractional laser used early in the post-surgical setting results in improved postoperative facial scars after a single treatment session .
METHODS	A prospective randomized , comparative split-scar study was conducted on 20 subjects between the ages of 20-90 .
METHODS	Subjects underwent Mohs surgery for nonmelanoma skin cancer of the face .
METHODS	Subsequent to tumor removal , subjects with a linear scar of 4 cm or greater were enrolled .
METHODS	On the day of suture removal , all subjects had one-half of their scar randomly selected and treated with a 10,600 nm CO2 fractional laser ( energy = 10 mJ ; density = 10 % ; spot size = 7 mm ; pulse = 1 ) .
METHODS	The untreated scar half served as a control .
METHODS	Scars were re-evaluated 12 weeks later .
METHODS	An independent blinded observer graded the scar halves with the Vancouver scar scale ( VSS ) immediately prior to treatment and 12 weeks after treatment .
METHODS	Subjects completed a visual analog scale ( VAS ) at the same time points .
RESULTS	Three months after laser treatment , a significant decrease in VSS and 3 of the 4 of its individual parameters were detected in both control and treated halves of the scar .
RESULTS	When comparing the laser group versus the control group , a statistically significant difference was not noted in VSS ( P = 0.31 ) but a statistically significant difference in patient VAS was detected ( P = 0.002 ) .
RESULTS	No side effects of the laser treatment were noted .
CONCLUSIONS	Facial wounds sutured in a layered manner heal well .
CONCLUSIONS	Patients prefer early fractional CO2 lasing of surgical scars , though use of the VSS failed to detect an objective difference between laser and control halves of scars .
CONCLUSIONS	Conservative laser settings , a single session treatment , and VSS insensitivity for surgical scars may influence these findings .

###25583029
BACKGROUND	Web-based learning is becoming an increasingly important instructional tool in nursing education .
BACKGROUND	Multimedia advancements offer the potential for creating authentic nursing activities for developing nursing competency in clinical practice .
OBJECTIVE	This study aims to describe the design , development , and evaluation of an interactive multimedia Web-based simulation for developing nurses ' competencies in acute nursing care .
METHODS	Authentic nursing activities were developed in a Web-based simulation using a variety of instructional strategies including animation video , multimedia instructional material , virtual patients , and online quizzes .
METHODS	A randomized controlled study was conducted on 67 registered nurses who were recruited from the general ward units of an acute care tertiary hospital .
METHODS	Following a baseline evaluation of all participants ' clinical performance in a simulated clinical setting , the experimental group received 3 hours of Web-based simulation and completed a survey to evaluate their perceptions of the program .
METHODS	All participants were re-tested for their clinical performances using a validated tool .
RESULTS	The clinical performance posttest scores of the experimental group improved significantly ( P < .001 ) from the pretest scores after the Web-based simulation .
RESULTS	In addition , compared to the control group , the experimental group had significantly higher clinical performance posttest scores ( P < .001 ) after controlling the pretest scores .
RESULTS	The participants from the experimental group were satisfied with their learning experience and gave positive ratings for the quality of the Web-based simulation .
RESULTS	Themes emerging from the comments about the most valuable aspects of the Web-based simulation include relevance to practice , instructional strategies , and fostering problem solving .
CONCLUSIONS	Engaging in authentic nursing activities using interactive multimedia Web-based simulation can enhance nurses ' competencies in acute care .
CONCLUSIONS	Web-based simulations provide a promising educational tool in institutions where large groups of nurses need to be trained in acute nursing care and accessibility to repetitive training is essential for achieving long-term retention of clinical competency .

###25897569
BACKGROUND	Although obstructive sleep apnea ( OSA ) is associated with impaired glucose tolerance and diabetes , it remains unclear whether OSA treatment with continuous positive airway pressure ( CPAP ) has metabolic benefits .
OBJECTIVE	To determine the effect of 8-hour nightly CPAP treatment on glucose metabolism in individuals with prediabetes and OSA .
METHODS	In a randomized controlled parallel group study , 39 participants were randomly assigned to receive either 8-hour nightly CPAP ( n = 26 ) or oral placebo ( n = 13 ) .
METHODS	Sleep was polysomnographically recorded in the laboratory on each night .
METHODS	CPAP adherence was ensured by continuous supervision .
METHODS	Participants continued their daily routine activities outside the laboratory .
METHODS	Glucose metabolism was assessed at baseline and after 2 weeks of assigned treatment using both the oral and intravenous glucose tolerance tests .
METHODS	The primary outcome was the overall glucose response as quantified by the area under the curve for glucose during 2-hour oral glucose tolerance testing .
METHODS	Secondary outcomes included fasting and 2-hour glucose and insulin , the area under the curves for insulin and insulin secretion , norepinephrine , insulin sensitivity , acute insulin response to glucose , and 24-hour blood pressure .
RESULTS	The overall glucose response was reduced ( treatment difference : -1,276.9 [ mg/dl ] min [ 95 % confidence interval , -2,392.4 to -161.5 ] ; P = 0.03 ) and insulin sensitivity was improved ( treatment difference : 0.77 [ mU/L ] ( -1 ) min ( -1 ) [ 95 % confidence interval , 0.03-1 .52 ] ; P = 0.04 ) with CPAP as compared with placebo .
RESULTS	Additionally , norepinephrine levels and 24-hour blood pressure were reduced with CPAP as compared with placebo .
CONCLUSIONS	In patients with prediabetes , 8-hour nightly CPAP treatment for 2 weeks improves glucose metabolism compared with placebo .
CONCLUSIONS	Thus , CPAP treatment may be beneficial for metabolic risk reduction .
CONCLUSIONS	Clinical trial registered with www.clinicaltrials.gov ( NCT 01156116 ) .

###24728774
BACKGROUND	Atrial fibrillation ( AF ) is an important independent risk factor for stroke and oral anticoagulation therapy provides a highly effective treatment to reduce this risk .
BACKGROUND	Active screening strategies improve detection of AF in comparison with routine care ; however , whether screen-detected patients have stroke risk profiles favouring anticoagulation is unclear .
BACKGROUND	Using data derived from the screening for AF in the elderly ( SAFE ) study , the aim of this article was to determine if patients with AF detected via active screening have stroke risk profiles that warrant prophylactic anticoagulation .
METHODS	Secondary analysis of data derived from 25 general practices within which cohorts of 200 patients were randomly allocated to opportunistic [ pulse and electrocardiogram ( ECG ) ] or systematic screening ( postal invitation for ECG ) .
METHODS	Stroke risk assessment was undertaken using baseline data extracted from medical records and CHADS2 criteria .
METHODS	CHADS2 scores were compared between the screening groups .
RESULTS	One hundred and forty-nine new cases of AF were detected , 75 via opportunistic screening and 74 via systematic screening .
RESULTS	CHADS2 scores were 1 in 83 % [ 95 % confidence interval ( CI ) 72.6-89 .6 ] of patients detected via opportunistic screening and 78 % ( 95 % CI 67.7-86 .2 ) detected via systematic screening .
RESULTS	There were no significant differences in stroke risk profiles of patients detected via opportunistic and systematic screenings .
CONCLUSIONS	Stroke risk profiles of patients detected via opportunistic and systematic screenings were similar .
CONCLUSIONS	Data derived from the SAFE study suggest that active screening for AF in patients aged 65 years in primary care is a useful screening programme with 78-83 % of patients identified eligible for anticoagulation treatment according to the CHADS2 criteria .

###25639126
BACKGROUND	Maternal malnutrition and poor gestational weight gain are the most important causes of low birthweight and infant mortality in Bangladesh .
OBJECTIVE	To assess the effect of short-term nutrition education on weight gain in the third trimester of pregnancy , birth outcomes , and breastfeeding .
METHODS	Three hundred pregnant women participated in this randomized , controlled trial during a 3-month intervention period .
METHODS	The study was conducted in two antenatal clinics in urban Dhaka .
METHODS	One group of women was given monthly education sessions during the third trimester of pregnancy to promote consumption of khichuri , while the control group received only routine services from the health facilities .
METHODS	Birthweight was recorded within 24 hours after delivery .
METHODS	Breastfeeding practices were observed for 1 month after delivery .
RESULTS	In the intervention group , maternal weight gain in the third trimester was 60 % higher ( 8.60 vs. 5.38 kg , p = .011 ) , mean birthweight was 20 % higher ( 2.98 vs. 2.49 kg , p < .001 ) , the rate of low birthweight was 94 % lower ( 2.7 % vs. 44.7 % ; p < .001 ) , and the rate of initiation of breastfeeding within 1 hour after birth was 52 % higher ( 86.0 % vs. 56.7 % , p < .001 ) , in comparison with the control group .
RESULTS	Birthweight was associated with frequency of intake of khichuri ( p < 0.001 ) .
CONCLUSIONS	Nutrition education with a focus on promoting consumption of khichuri during the third trimester of pregnancy significantly reduced the rate of low birthweight and increased maternal weight gain .

###25537522
BACKGROUND	Premenopausal women diagnosed with breast cancer are at risk for psychological and behavioral disturbances after cancer treatment .
BACKGROUND	Targeted interventions are needed to address the needs of this vulnerable group .
METHODS	This randomized trial provided the first evaluation of a brief , mindfulness-based intervention for younger breast cancer survivors designed to reduce stress , depression , and inflammatory activity .
METHODS	Women diagnosed with early stage breast cancer at or before age 50 who had completed cancer treatment were randomly assigned to a 6-week Mindful Awareness Practices ( MAPS ) intervention group ( n = 39 ) or to a wait-list control group ( n = 32 ) .
METHODS	Participants completed questionnaires before and after the intervention to assess stress and depressive symptoms ( primary outcomes ) as well as physical symptoms , cancer-related distress , and positive outcomes .
METHODS	Blood samples were collected to examine genomic and circulating markers of inflammation .
METHODS	Participants also completed questionnaires at a 3-month follow-up assessment .
RESULTS	In linear mixed models , the MAPS intervention led to significant reductions in perceived stress ( P = .004 ) and marginal reductions in depressive symptoms ( P = .094 ) , as well as significant reductions in proinflammatory gene expression ( P = .009 ) and inflammatory signaling ( P = .001 ) at postintervention .
RESULTS	Improvements in secondary outcomes included reduced fatigue , sleep disturbance , and vasomotor symptoms and increased peace and meaning and positive affect ( P < .05 for all ) .
RESULTS	Intervention effects on psychological and behavioral measures were not maintained at the 3-month follow-up assessment , although reductions in cancer-related distress were observed at that assessment .
CONCLUSIONS	A brief , mindfulness-based intervention demonstrated preliminary short-term efficacy in reducing stress , behavioral symptoms , and proinflammatory signaling in younger breast cancer survivors .

###25693012
BACKGROUND	In patients with metastatic breast cancer that is positive for human epidermal growth factor receptor 2 ( HER2 ) , progression-free survival was significantly improved after first-line therapy with pertuzumab , trastuzumab , and docetaxel , as compared with placebo , trastuzumab , and docetaxel .
BACKGROUND	Overall survival was significantly improved with pertuzumab in an interim analysis without the median being reached .
BACKGROUND	We report final prespecified overall survival results with a median follow-up of 50 months .
METHODS	We randomly assigned patients with metastatic breast cancer who had not received previous chemotherapy or anti-HER2 therapy for their metastatic disease to receive the pertuzumab combination or the placebo combination .
METHODS	The secondary end points of overall survival , investigator-assessed progression-free survival , independently assessed duration of response , and safety are reported .
METHODS	Sensitivity analyses were adjusted for patients who crossed over from placebo to pertuzumab after the interim analysis .
RESULTS	The median overall survival was 56.5 months ( 95 % confidence interval [ CI ] , 49.3 to not reached ) in the group receiving the pertuzumab combination , as compared with 40.8 months ( 95 % CI , 35.8 to 48.3 ) in the group receiving the placebo combination ( hazard ratio favoring the pertuzumab group , 0.68 ; 95 % CI , 0.56 to 0.84 ; P < 0.001 ) , a difference of 15.7 months .
RESULTS	This analysis was not adjusted for crossover to the pertuzumab group and is therefore conservative .
RESULTS	Results of sensitivity analyses after adjustment for crossover were consistent .
RESULTS	Median progression-free survival as assessed by investigators improved by 6.3 months in the pertuzumab group ( hazard ratio , 0.68 ; 95 % CI , 0.58 to 0.80 ) .
RESULTS	Pertuzumab extended the median duration of response by 7.7 months , as independently assessed .
RESULTS	Most adverse events occurred during the administration of docetaxel in the two groups , with long-term cardiac safety maintained .
CONCLUSIONS	In patients with HER2-positive metastatic breast cancer , the addition of pertuzumab to trastuzumab and docetaxel , as compared with the addition of placebo , significantly improved the median overall survival to 56.5 months and extended the results of previous analyses showing the efficacy of this drug combination .
CONCLUSIONS	( Funded by F. Hoffmann-La Roche and Genentech ; CLEOPATRA ClinicalTrials.gov number , NCT00567190 . )

###25879513
BACKGROUND	Sugar overconsumption and chronic stress are growing health concerns because they both may increase the risk for obesity and its related diseases .
BACKGROUND	Rodent studies suggest that sugar consumption may activate a glucocorticoid-metabolic-brain-negative feedback pathway , which may turn off the stress response and thereby reinforce habitual sugar overconsumption .
OBJECTIVE	The objective of the study was to test our hypothesized glucocorticoid-metabolic-brain model in women consuming beverages sweetened with either aspartame of sucrose .
METHODS	This was a parallel-arm , double-masked diet intervention study .
METHODS	The study was conducted at the University of California , Davis , Clinical and Translational Science Center 's Clinical Research Center and the University of California , Davis , Medical Center Imaging Research Center .
METHODS	Nineteen women ( age range 18-40 y ) with a body mass index ( range 20-34 kg/m ( 2 ) ) who were a subgroup from a National Institutes of Health-funded investigation of 188 participants assigned to eight experimental groups .
METHODS	The intervention consisted of sucrose - or aspartame-sweetened beverage consumption three times per day for 2 weeks .
METHODS	Salivary cortisol and regional brain responses to the Montreal Imaging Stress Task were measured .
RESULTS	Compared with aspartame , sucrose consumption was associated with significantly higher activity in the left hippocampus ( P = .001 ) .
RESULTS	Sucrose , but not aspartame , consumption associated with reduced ( P = .024 ) stress-induced cortisol .
RESULTS	The sucrose group also had a lower reactivity to naltrexone , significantly ( P = .041 ) lower nausea , and a trend ( P = .080 ) toward lower cortisol .
CONCLUSIONS	These experimental findings support a metabolic-brain-negative feedback pathway that is affected by sugar and may make some people under stress more hooked on sugar and possibly more vulnerable to obesity and its related conditions .

###24560995
OBJECTIVE	To compare the clinical outcomes of wavefront-guided and wavefront-optimized laser in situ keratomileusis ( LASIK ) .
METHODS	Prospective , randomized , fellow-eye-controlled study .
METHODS	The setting was a single academic institution .
METHODS	The study population included 110 eyes of 55 patients with myopia with and without astigmatism .
METHODS	One eye of each patient was randomized to undergo wavefront-guided LASIK by the AMO Visx CustomVue S4 IR excimer laser system ; the fellow eye received wavefront-optimized LASIK by the Alcon Allegretto Wave Eye-Q 400 Hz excimer laser system .
METHODS	Corneal flaps were constructed using the Intralase FS 60 Hz femtosecond laser .
METHODS	Patients were followed at postoperative months 1 , 3 , 6 , and 12 .
METHODS	The study 's main outcome measures were uncorrected visual acuity , stability of refractive correction , contrast sensitivity , and wavefront aberrometry .
RESULTS	After 12 months , LASIK eyes had achieved visual acuity of 20/12 .5 or better ( 30 eyes , 56 % ) in the wavefront-guided group compared to those receiving wavefront-optimized treatment ( 22 eyes , 41 % ) ( P = 0.016 ) .
RESULTS	Average spherical equivalent refractions were -0.13 0.46 diopters in wavefront-guided eyes whereas in wavefront-optimized eyes the refractions were -0.41 0.38 diopters at 12 months .
RESULTS	Wavefront-guided eyes also achieved better best-corrected visual acuity at both the 5 % and 25 % contrast levels ( P = 0.022 and P = 0.004 , respectively ) .
RESULTS	There were no differences in levels of residual astigmatism ( P = 0.798 ) or in higher order aberrations ( P = 0.869 ) .
CONCLUSIONS	Both wavefront-guided and wavefront-optimized treatments are able to correct myopia safely and effectively in eyes with and without astigmatism .
CONCLUSIONS	However , wavefront-guided treatment platforms appear to offer significant advantages in terms of residual refractive error , uncorrected distance acuity and contrast sensitivity .

###24358266
BACKGROUND	Impairments in mismatch negativity ( MMN ) generation have been consistently reported in patients with schizophrenia .
BACKGROUND	However , underlying oscillatory activity of MMN deficits in schizophrenia and the relationship with cognitive impairments have not been investigated in detail .
BACKGROUND	Time-frequency power and phase analyses can provide more detailed measures of brain dynamics of MMN deficits in schizophrenia .
METHODS	21 patients with schizophrenia and 21 healthy controls were tested with a roving frequency paradigm to generate MMN .
METHODS	Time-frequency domain power and phase-locking ( PL ) analysis was performed on all trials using short-time Fourier transforms with Hanning window tapering .
METHODS	A comprehensive battery ( CANTAB ) was used to assess neurocognitive functioning .
RESULTS	Mean MMN amplitude was significantly lower in patients with schizophrenia ( 95 % CI 0.18 - 0.77 ) .
RESULTS	Patients showed significantly lower EEG power ( 95 % CI -1.02 - -0.014 ) in the ~ 4-7 Hz frequency range ( theta band ) between 170 and 210 ms. Patients with schizophrenia showed cognitive impairment in multiple domains of CANTAB .
RESULTS	However , MMN impairments in amplitude and power were not correlated with clinical measures , medication dose , social functioning or neurocognitive performance .
CONCLUSIONS	The findings from this study suggested that while MMN may be a useful marker to probe NMDA receptor mediated mechanisms and associated impairments in gain control and perceptual changes , it may not be a useful marker in association with clinical or cognitive changes .
CONCLUSIONS	Trial-by-trial EEG power analysis can be used as a measure of brain dynamics underlying MMN deficits which also can have implications for the use of MMN as a biomarker for drug discovery .

###25762232
BACKGROUND	Despite the availability of new antibiotics such as daptomycin , methicillin-resistant Staphylococcus aureus ( MRSA ) bacteraemia continues to be associated with high clinical failure rates .
BACKGROUND	Combination therapy has been proposed as an alternative to improve outcomes but there is a lack of clinical studies .
BACKGROUND	The study aims to demonstrate that combination of daptomycin plus fosfomycin achieves higher clinical success rates in the treatment of MRSA bacteraemia than daptomycin alone .
METHODS	A multicentre open-label , randomised phase III study .
METHODS	Adult patients hospitalised with MRSA bacteraemia will be randomly assigned ( 1:1 ) to group 1 : daptomycin 10mg/kg/24h intravenous ; or group 2 : daptomycin 10mg/kg/24h intravenous plus fosfomycin 2gr/6g intravenous .
METHODS	The main outcome will be treatment response at week 6 after stopping therapy ( test-of-cure ( TOC ) visit ) .
METHODS	This is a composite variable with two values : Treatment success : resolution of clinical signs and symptoms ( clinical success ) and negative blood cultures ( microbiological success ) at the TOC visit .
METHODS	Treatment failure : if any of the following conditions apply : ( 1 ) lack of clinical improvement at 72h or more after starting therapy ; ( 2 ) persistent bacteraemia ( positive blood cultures on day 7 ) ; ( 3 ) therapy is discontinued early due to adverse effects or for some other reason based on clinical judgement ; ( 4 ) relapse of MRSA bacteraemia before the TOC visit ; ( 5 ) death for any reason before the TOC visit .
METHODS	Assuming a 60 % cure rate with daptomycin and a 20 % difference in cure rates between the two groups , 103 patients will be needed for each group ( :0.05 , : 0.2 ) .
METHODS	Statistical analysis will be based on intention to treat , as well as per protocol and safety analysis .
BACKGROUND	The protocol was approved by the Spanish Medicines and Healthcare Products Regulatory Agency ( AEMPS ) .
BACKGROUND	The sponsor commits itself to publishing the data in first quartile peer-review journals within 12months of the completion of the study .
BACKGROUND	NCT01898338 .

###25965082
BACKGROUND	Exacerbation of Graves ' orbitopathy ( GO ) after radioiodine ( RAI ) therapy has been examined in some populations but has not been fully described in Japanese populations .
OBJECTIVE	The purpose of this study was to clarify the characteristics of GO exacerbation after RAI therapy and the effectiveness of low-dose prophylactic corticosteroid ( PCS ) .
METHODS	This was a prospective randomized study in Tokyo , Japan .
METHODS	Between June 2011 and June 2012 , 295 patients with Graves ' disease with either inactive GO or no GO received RAI therapy .
METHODS	Of these , 147 received no PCS ( PCS-Off group ) , whereas 148 received low-dose PCS ( starting dose , 15 mg/day of prednisolone ) for 6 weeks ( PCS-On group ) .
METHODS	We used magnetic resonance imaging to thoroughly evaluate GO before and 1 year after RAI therapy .
METHODS	Outcomes of GO 1 year after RAI therapy were determined .
RESULTS	GO exacerbation occurred in 29 patients ( 9.8 % ) , and only 7 patients ( 2.4 % ) required ophthalmic treatment .
RESULTS	No significant difference in the frequency of GO exacerbation was seen between the groups ( PCS-On group : n = 18 [ 12.1 % ] ; PCS-Off group : n = 11 [ 7.5 % ] ; P = .17 ) .
RESULTS	Significant prognostic factors were identified as thyroid-stimulating antibody ( by 100 % linear increase : risk ratio , 1.15 ; 95 % confidence interval , 1.07-1 .24 ; P = .0003 ) and clinical activity score ( 1 vs 0 : risk ratio , 6.40 ; 95 % confidence interval , 2.17-19 .7 ; P = .0009 ) .
CONCLUSIONS	Exacerbation of GO after RAI therapy in the Japanese population appears less common than in other populations .
CONCLUSIONS	Low-dose PCS did not produce a significant preventive effect and appeared insufficient .
CONCLUSIONS	Patients presenting with risk factors would thus be recommended to receive higher-dose PCS .

###24685559
BACKGROUND	Motives for use have been identified as important predictors of substance use and related problems ; however , little is known about how motives for use change following an intervention and how this change may impact future substance use behaviors .
BACKGROUND	The present study sought to describe change in motives following an intervention for marijuana-dependent adults .
BACKGROUND	Furthermore , investigators examined change in motives as a predictor of treatment outcome .
METHODS	The study randomized 74 adults to one of two conditions : both of which received 9-sessions base treatment of cognitive behavioral therapy and motivational enhancement therapy and had access to additional sessions of cognitive behavioral treatment on an as-needed basis .
METHODS	The experimental condition received two additional `` check-ups '' during the course of follow-up .
RESULTS	Significant decreases in reported frequency of motives used were observed following treatment .
RESULTS	Changes in Expansion and Coping were associated with differential treatment outcomes .
RESULTS	Decreases in Expansion were associated with poorer treatment outcome , while decreases in Coping were associated with better treatment outcome .
CONCLUSIONS	The relationship between expansion motives and outcomes was paradoxical .
CONCLUSIONS	Although there were some inconsistencies in the findings , the results regarding the coping motive were consistent with hypotheses and may have important implications for treatment .

###25468160
BACKGROUND	The bile acid derivative 6-ethylchenodeoxycholic acid ( obeticholic acid ) is a potent activator of the farnesoid X nuclear receptor that reduces liver fat and fibrosis in animal models of fatty liver disease .
BACKGROUND	We assessed the efficacy of obeticholic acid in adult patients with non-alcoholic steatohepatitis .
METHODS	We did a multicentre , double-blind , placebo-controlled , parallel group , randomised clinical trial at medical centres in the USA in patients with non-cirrhotic , non-alcoholic steatohepatitis to assess treatment with obeticholic acid given orally ( 25 mg daily ) or placebo for 72 weeks .
METHODS	Patients were randomly assigned 1:1 using a computer-generated , centrally administered procedure , stratified by clinical centre and diabetes status .
METHODS	The primary outcome measure was improvement in centrally scored liver histology defined as a decrease in non-alcoholic fatty liver disease activity score by at least 2 points without worsening of fibrosis from baseline to the end of treatment .
METHODS	A planned interim analysis of change in alanine aminotransferase at 24 weeks undertaken before end-of-treatment ( 72 weeks ) biopsies supported the decision to continue the trial ( relative change in alanine aminotransferase -24 % , 95 % CI -45 to -3 ) .
METHODS	A planned interim analysis of the primary outcome showed improved efficacy of obeticholic acid ( p = 00024 ) and supported a decision not to do end-of-treatment biopsies and end treatment early in 64 patients , but to continue the trial to obtain the 24-week post-treatment measures .
METHODS	Analyses were done by intention-to-treat .
METHODS	This trial was registered with ClinicalTrials.gov , number NCT01265498 .
RESULTS	Between March 16 , 2011 , and Dec 3 , 2012 , 141 patients were randomly assigned to receive obeticholic acid and 142 to placebo .
RESULTS	50 ( 45 % ) of 110 patients in the obeticholic acid group who were meant to have biopsies at baseline and 72 weeks had improved liver histology compared with 23 ( 21 % ) of 109 such patients in the placebo group ( relative risk 19 , 95 % CI 13 to 28 ; p = 00002 ) .
RESULTS	33 ( 23 % ) of 141 patients in the obeticholic acid developed pruritus compared with nine ( 6 % ) of 142 in the placebo group .
CONCLUSIONS	Obeticholic acid improved the histological features of non-alcoholic steatohepatitis , but its long-term benefits and safety need further clarification .
BACKGROUND	National Institute of Diabetes and Digestive and Kidney Diseases , Intercept Pharmaceuticals .

###25547978
BACKGROUND	Strategies are needed to help general practitioners ( GPs ) promote smoking cessation as recommended by guidelines .
BACKGROUND	This study examines whether the quality of action planning among GPs improves their provision of smoking cessation care .
METHODS	The effectiveness of a 1-h training programme was examined in a cluster randomised controlled trial in which 49 GPs participated .
METHODS	GPs who followed the training ( intervention group ; n = 25 ) formulated action plans related to i ) enquiring about smoking , ii ) advising to quit smoking , and iii ) arranging follow-up for smokers motivated to quit .
METHODS	GPs also formulated a coping plan for encountering smokers not motivated to quit .
METHODS	The quality of these plans ( plan specificity ) was rated and , 6 weeks after the training , GPs reported on the performance of these plans ( plan enactment ) .
METHODS	Multilevel regression analyses were used to examine the effects of plan specificity and plan enactment on patient-reported smoking cessation activities of the GPs in the intervention group ( n = 1,632 patients ) compared with the control group ( n = 1,769 patients ) .
RESULTS	Compared to the control group , GPs who formulated a highly specific action plan during the training asked their patients about smoking more often after the training compared to prior to the training ( OR 2.11 , 95 % CI 1.51-2 .95 ) .
RESULTS	GPs were most likely to have asked patients about smoking after the training compared to prior to the training when they had enacted a highly specific formulated action plan ( OR 3.08 , 95 % CI 2.04-4 .64 ) .
RESULTS	The effects of GP plan specificity and plan enactment on asking patient about smoking were most prominent among GPs who , at baseline , intended to provide smoking cessation care .
CONCLUSIONS	A highly specific action plan formulated by a GP on when , how , and by whom patients will be asked about smoking had a positive effect on GPs ' asking patients about smoking , especially when these professionals also reported to have enacted this plan .
CONCLUSIONS	This effect was most prominent among GPs who intended to provide smoking cessation care prior to the intervention .
CONCLUSIONS	Training in devising personalised coping plans is recommended to further increase GPs ' provision of advice to quit smoking and arranging follow-up support to quit smoking .

###24493296
OBJECTIVE	The preferred approach to the management of common bile duct ( CBD ) stones is uncertain , with single-stage laparoscopic cholecystectomy and CBD exploration vs. two-stage preoperative endoscopic CBD clearance followed by laparoscopic cholecystectomy being debated .
OBJECTIVE	To address this , a prospective randomized study which compared these two management strategies was undertaken .
METHODS	Between Jan 2002 and Dec 2005 , patients with gallstones and common bile duct stones diagnosed by preoperative ultrasonography and magnetic resonance cholangiopancreatography were randomized to single-stage vs. two-stage treatment .
METHODS	In a single-stage group , laparoscopic cholecystectomy and CBD exploration were undertaken at the same operation , whereas in a two-stage group , endoscopic stone clearance was followed by laparoscopic cholecystectomy 2-5 days later .
METHODS	Early treatment success and complications and longer-term follow-up for the two groups were compared .
RESULTS	Two hundred twenty-one patients were enrolled in the trial , 110 in the single-stage group and 111 in the two-stage group .
RESULTS	There was no significant difference in the success rate of CBD clearance ( 93.6 vs. 94.6 % , p = 0.76 ) or the complication rates ( 3.6 vs. 5.1 % , p = 0.527 ) between the groups .
RESULTS	However , at longer-term follow-up , recurrent CBD stones were seen more often in the two-stage group ( 9.5 vs. 2.1 % , p = 0.037 ) .
CONCLUSIONS	The single-stage and two-stage approaches were equally effective in achieving initial clearance of CBD stones .
CONCLUSIONS	However , recurrent CBD stones occurred more commonly in patients who had undergone two-stage treatment with initial endoscopic stone clearance , followed by laparoscopic cholecystectomy .

###25157543
BACKGROUND	Amino-acid ( AA ) metabolic signatures differ in insulin-resistant ( IR ) obese vs normal-weight subjects , improve after weight loss , and seem to predict the risk of type 2 diabetes .
BACKGROUND	It is unknown whether weight-maintaining dietary measures aimed at influencing IR alter AA signatures of high-risk subjects .
METHODS	In the randomized controlled Protein , Fiber and Metabolic Syndrome ( ProFiMet ) trial we investigated effects of four isoenergetic , moderately fat-reduced diets varying in protein and cereal-fiber contents on complete AA metabolic signatures in 76 group-matched overweight or obese high-risk subjects .
METHODS	We analyzed the relation of whole-body and hepatic IR with AA signatures , body fat composition and liver fat , after 0 , 6 , and 18 weeks of dietary intervention .
METHODS	Discrimination between diets was further enhanced by providing tailored dietary supplements for twice-daily consumption over 18 weeks in all groups .
RESULTS	Baseline AA , including branched-chain signatures significantly related to IR , liver fat , and visceral fat mass .
RESULTS	Isoenergetic variation of protein and cereal-fiber dietary contents , but not fat restriction , significantly influenced IR , whereas the relation of AA with IR changed with all diets .
RESULTS	The tryptophan ratio was significantly suppressed in obese vs overweight participants , but increased after 6 weeks of high cereal-fiber intake to a nonobese phenotype .
RESULTS	Modeling analyses revealed diet-induced alterations of complex AA profiles to relate to 70 % and 62 % of changes in whole-body and hepatic IR .
CONCLUSIONS	We demonstrate that relatively short-term isoenergetic changes in the diet significantly alter the relation of AA signatures with IR , with possible implications on the determination and treatment of diabetes risk .

###24604289
BACKGROUND	Recently , men with intermediate-risk prostate cancer ( PC ) were classified into favorable and unfavorable categories ; however , whether the risk of PC-specific mortality ( PCSM ) among men with high-risk PC versus unfavorable intermediate-risk PC is increased is unknown .
METHODS	In a prospective , randomized trial conducted between 1995 and 2001 , 206 men with intermediate-risk or high-risk PC were randomized to receive 70 Gy with or without 6 months of androgen-suppression therapy ( AST ) .
METHODS	The subgroup of 197 patients with information available on the percentage of positive biopsies formed the cohort .
METHODS	Fine and Gray regression analysis was used to assess whether men with high-risk PC versus unfavorable intermediate-risk PC had an increased risk of PCSM .
RESULTS	After a median follow-up of 14.3 years , there were 127 deaths ( 64.5 % ) , including 22 deaths ( 17.3 % ) from PC .
RESULTS	There were no PC deaths in the favorable intermediate-risk group .
RESULTS	There was an increase in the risk of PCSM among men with high-risk PC versus unfavorable intermediate-risk PC , but the difference was not significant ( adjusted hazard ratio , 1.59 ; 95 % confidence interval , 0.66-3 .83 ; P = .30 ) after adjusting for age , randomized treatment arm , and comorbidity .
CONCLUSIONS	The lack of PC deaths among men with favorable intermediate-risk PC suggests that adding AST may not reduce their risk of PCSM ; whereas many men with unfavorable intermediate-risk PC are at risk for harboring occult PC with Gleason scores from 8 to 10 and , if proven , would benefit from long-term AST .
CONCLUSIONS	Multiparametric magnetic resonance imaging and targeted biopsy of suspicious lesions should be considered to identify PC with Gleason scores from 8 to 10 in these men .

###24831360
OBJECTIVE	The purpose of this study was to demonstrate the activity of agmatine , an inducible nitric oxide synthase ( iNOS ) inhibitor and selective N-methyl-D-aspartate receptor ( NMDAR ) antagonist , on reducing tissue damage in distal part of traumatic nerve in an experimental rat peripheral nerve injury model .
METHODS	Sciatic nerves of 30 Sprague Dawley male rats were used .
METHODS	Rats were divided into 5 groups ; group 1 ( n = 6 ) , control group ; group 2 ( n = 6 ) , axonotmesis + placebo group ; group 3 ( n = 6 ) , axonotmesis + 50 mg/kg agmatine treatment group ; group 4 ( n = 6 ) , neurotmesis + placebo group ; group 5 ( n = 6 ) , neurotmesis + 50 mg/kg agmatine treatment group .
METHODS	Axonolysis , axon degeneration , edema , hemorrhage , and inflammation were evaluated in histopathologic examinations of all the groups .
RESULTS	When group 2 was compared with group 3 in histopathologic sections , axonolysis was less in group 3 ( p = 0.007 ) , as was axon degeneration ( p = 0.022 ) and edema ( p = 0.018 ) .
RESULTS	When group 4 was compared with group 5 , axonolysis was less in group 5 ( p = 0.009 ) , as was axon degeneration ( p = 0.006 ) and edema ( p = 0.021 ) .
CONCLUSIONS	This study demonstrated agmatine to have antioxidant and antineurotoxic effects in an experimental rat peripheral nerve injury model .

###25214238
BACKGROUND	Health-related quality of life is often collected in clinical studies , and forms a cornerstone of economic evaluation .
BACKGROUND	This study had two objectives , firstly to report and compare pre - and post-progression health state utilities in advanced melanoma when valued by different methods and secondly to explore the validity of progression-based health state utility modelling compared to modelling based upon time to death .
METHODS	Utilities were generated from the ipilimumab MDX010-20 trial ( Clinicaltrials.gov Identifier : NCT00094653 ) using the condition-specific EORTC QLQ-C30 ( via the EORTC-8D ) and generic SF-36v2 ( via the SF-6D ) preference-based measures .
METHODS	Analyses by progression status and time to death were conducted on the patient-level data from the MDX010-20 trial using generalised estimating equations fitted in Stata , and the predictive abilities of the two approaches compared .
RESULTS	Mean utility showed a decrease on disease progression in both the EORTC-8D ( 0.813 to 0.776 ) and the SF-6D ( 0.648 to 0.626 ) .
RESULTS	Whilst higher utilities were obtained using the EORTC-8D , the relative decrease in utility on progression was similar between measures .
RESULTS	When analysed by time to death , both EORTC-8D and SF-6D showed a large decrease in utility in the 180 days prior to death ( from 0.831 to 0.653 and from 0.667 to 0.544 , respectively ) .
RESULTS	Compared to progression status alone , the use of time to death gave similar or better estimates of the original data when used to predict patient utility in the MDX010-20 study .
RESULTS	Including both progression status and time to death further improved model fit .
RESULTS	Utilities seen in MDX010-20 were also broadly comparable with those seen in the literature .
CONCLUSIONS	Patient-level utility data should be analysed prior to constructing economic models , as analysis solely by progression status may not capture all predictive factors of patient utility and time to death may , as death approaches , be as or more important .
CONCLUSIONS	Additionally this study adds to the body of evidence showing that different scales lead to different health state values .
CONCLUSIONS	Further research is needed on how different utility instruments ( the SF-6D , EORTC-8D and EQ-5D ) relate to each other in different disease areas .

###25161302
BACKGROUND	Recent technological advances in nebulization permit researchers to target specific parts of the lungs by modifying delivery method .
BACKGROUND	The aim of this study was to compare the central and peripheral targeted modalities of administration .
METHODS	Lung and regional deposition of inhaled technetium-99m diethylene triamine penta-acetic was measured by scintigraphy after peripheral and central targeted modalities of administration with an Akita device in 6 healthy subjects .
RESULTS	Drug targeting nebulization delivered a large amount of drug into the peripheral part of the lung independent of the modality ( outer-to-inner deposition ratio of 1.24 0.21 vs. 1.22 0.14 for central and peripheral modalities , respectively ) , but there was no difference in lung deposition ( whole-body deposition , 83.3 6.5 % vs. 82.8 7.3 % , P = .86 ) or regional deposition ( P = .77 ) between both modalities .
RESULTS	The extrathoracic deposition was < 20 % of the whole-body deposition , without a difference between modalities ( P = .86 ) .
CONCLUSIONS	This study shows for the first time that choosing 2 different specific drug targeting nebulization modes does not influence the amount of drug delivered into the lung in healthy male subjects .
CONCLUSIONS	Moreover , the modes do not modify the site of deposition under the conditions of our study .

###24560181
OBJECTIVE	To assess whether an oxygen saturation ( Spo2 ) target of 85 % -89 % compared with 91 % -95 % reduced the incidence of the composite outcome of death or major disability at 2 years of age in infants born at < 28 weeks ' gestation .
METHODS	A total 340 infants were randomized to a lower or higher target from < 24 hours of age until 36 weeks ' gestational age .
METHODS	Blinding was achieved by targeting a displayed Spo2 of 88 % -92 % using a saturation monitor offset by 3 % within the range 85 % -95 % .
METHODS	True saturations were displayed outside this range .
METHODS	Follow-up at 2 years ' corrected age was by pediatric examination and formal neurodevelopmental assessment .
METHODS	Major disability was gross motor disability , cognitive or language delay , severe hearing loss , or blindness .
RESULTS	The primary outcome was known for 335 infants with 33 using surrogate language information .
RESULTS	Targeting a lower compared with a higher Spo2 target range had no significant effect on the rate of death or major disability at 2 years ' corrected age ( 65/167 [ 38.9 % ] vs 76/168 [ 45.2 % ] ; relative risk 1.15 , 95 % CI 0.90-1 .47 ) or any secondary outcomes .
RESULTS	Death occurred in 25 ( 14.7 % ) and 27 ( 15.9 % ) of those randomized to the lower and higher target , respectively , and blindness in 0 % and 0.7 % .
CONCLUSIONS	Although there was no benefit or harm from targeting a lower compared with a higher saturation in this trial , further information will become available from the prospectively planned meta-analysis of this and 4 other trials comprising a total of nearly 5000 infants .

###24812432
OBJECTIVE	Insulin degludec/insulin aspart ( IDegAsp ) is the first combination of a basal insulin with an ultralong duration of action , and a rapid-acting insulin in a single injection .
OBJECTIVE	This trial compared IDegAsp with biphasic insulin aspart 30 ( BIAsp 30 ) in adults with type 2 diabetes inadequately controlled with once - or twice-daily ( OD or BID ) pre - or self-mixed insulin with or without oral antidiabetic drugs .
METHODS	In this 26-week , randomized , open-label , multinational , treat-to-target trial , participants ( mean age 58.7 years , duration of diabetes 13 years , BMI 29.3 kg/m ( 2 ) , and HbA1c 8.4 % [ 68 mmol/mol ] ) were exposed ( 1:1 ) to BID injections of IDegAsp ( n = 224 ) or BIAsp 30 ( n = 222 ) , administered with breakfast and the main evening meal and dose titrated to a self-measured premeal plasma glucose ( PG ) target of 4.0-5 .0 mmol/L .
RESULTS	After 26 weeks , mean HbA1c was 7.1 % ( 54 mmol/mol ) for both groups , with IDegAsp achieving the prespecified noninferiority margin for mean change in HbA1c ( estimated treatment difference [ ETD ] -0.03 % points [ 95 % CI -0.18 to 0.13 ] ) .
RESULTS	Treatment with IDegAsp was superior in lowering fasting PG ( ETD -1.14 mmol/L [ 95 % CI -1.53 to -0.76 ] , P < 0.001 ) and had a significantly lower final mean daily insulin dose ( estimated rate ratio 0.89 [ 95 % CI 0.83-0 .96 ] , P = 0.002 ) .
RESULTS	Fewer confirmed , nocturnal confirmed , and severe hypoglycemia episodes were reported for IDegAsp compared with BIAsp 30 .
CONCLUSIONS	IDegAsp BID effectively improves HbA1c and fasting PG levels with fewer hypoglycemia episodes versus BIAsp 30 in patients with uncontrolled type 2 diabetes previously treated with once - or twice-daily pre - or self-mixed insulin .

###24227358
BACKGROUND	Excessive intravenous fluid prescription may play a causal role in postoperative complications following major gastrointestinal resectional surgery .
BACKGROUND	The aim of this study was to investigate whether fluid and salt restriction would decrease postoperative complications compared with a more modern controlled liberal regimen .
METHODS	In this observer-blinded single-site randomized clinical trial consecutive patients undergoing major gastrointestinal resectional surgery were randomized to receive either a liberal control fluid regimen or a restricted fluid and salt regimen .
METHODS	The primary outcome was postoperative complications of grade II and above ( moderate to severe ) .
RESULTS	Some 240 patients ( 194 colorectal resections and 46 oesophagogastric resections ) were enrolled in the study ; 121 patients were randomized to the restricted regimen and 119 to the control ( liberal ) regimen .
RESULTS	During surgery the control group received a median ( interquartile range ) fluid volume of 2033 ( 1576-2500 ) ml and sodium input of 282 ( 213-339 ) mmol , compared with 1000 ( 690-1500 ) ml and 142 ( 93-218 ) mmol respectively in the restricted group .
RESULTS	There was no significant difference in major complication rate between groups ( 380 and 390 per cent respectively ) .
RESULTS	Median ( range ) hospital stay was 8 ( 3-101 ) days in the controls and 8 ( range 3-76 ) days among those who received restricted fluids .
RESULTS	There were four in-hospital deaths in the control group and two in the restricted group .
RESULTS	Substantial differences in weight change , serum sodium , osmolality and urine : serum osmolality ratio were observed between the groups .
CONCLUSIONS	There were no significant differences in major complication rates , length of stay and in-hospital deaths when fluid restriction was used compared with a more liberal regimen .
BACKGROUND	ISRCTN39295230 ( http://www.controlled-trials.com ) .

###25773565
BACKGROUND	Sample size calculations for treatment trials that aim to assess health-related quality-of-life ( HRQOL ) outcomes are often difficult to perform .
BACKGROUND	Researchers must select a target minimal clinically important difference ( MCID ) in HRQOL for the trial , estimate the effect size of the intervention , and then consider the responsiveness of different HRQOL measures for detecting improvements .
BACKGROUND	Generic preference-based HRQOL measures are usually less sensitive to gains in HRQOL than are disease-specific measures , but are nonetheless recommended to quantify an impact on HRQOL that can be translated into quality-adjusted life-years during cost-effectiveness analyses .
BACKGROUND	Mapping disease-specific measures onto generic measures is a proposed method for yielding more efficient sample size requirements while retaining the ability to generate utility weights for cost-effectiveness analyses .
OBJECTIVE	This study sought to test this mapping strategy to calculate and compare the effect on sample size of three different methods .
METHODS	Three different methods were used for determining an MCID in HRQOL in patients with incontinence : 1 ) a global rating of improvement , 2 ) an incontinence-specific HRQOL instrument , and 3 ) a generic preference-based HRQOL instrument using mapping coefficients .
RESULTS	The sample size required to detect a 20 % difference in the MCID for the global rating of improvement was 52 per trial arm , 172 per arm for the incontinence-specific HRQOL outcome , and 500 per arm for the generic preference-based HRQOL outcome .
CONCLUSIONS	We caution that treatment trials of conditions for which improvements are not easy to measure on generic HRQOL instruments will still require significantly greater sample size even when mapping functions are used to try to gain efficiency .

###25135124
BACKGROUND	Sleep deprivation is common in critically ill patients in intensive care units ( ICU ) .
BACKGROUND	It can result in delirium , difficulty weaning , repeated nosocomial infections , prolonged ICU length of stay and increased ICU mortality .
BACKGROUND	Melatonin , a physiological sleep regulator , is well known to benefit sleep quality in certain people , but evidence for the effectiveness in ICU sleep disturbance is limited .
METHODS	This study has a prospective , randomized , double-blind , controlled , parallel-group design .
METHODS	Eligible patients are randomly assigned to one of the two treatment study groups , labelled the ` melatonin group ' or the ` placebo group ' .
METHODS	A dose of 3 mg of oral melatonin or placebo is administered at 9:00 pm on four consecutive days .
METHODS	Earplugs and eye masks are made available to every participant .
METHODS	We plan to enrol 198 patients .
METHODS	The primary outcome is the objective sleep quality measured by the 24-hour polysomnography .
METHODS	The secondary outcomes are the subjective sleep quality assessed by the Richards Campbell Sleep Questionnaire , the anxiety level evaluated by the Visual Analogue Scale-Anxiety , the number of delirium-free days in 8 and 28 days , the number of ventilation-free days in 28 days , the number of antibiotic-free days , ICU length of stay , the overall ICU mortality in 28 days and the incidence and severity of the side effects of melatonin in ICU patients .
METHODS	Additionally , the body stress levels , oxidative stress levels and inflammation levels are obtained via measuring the plasma melatonin , cortisone , norepinephrine , malonaldehyde ( MDA ) , superoxide dismutase ( SOD ) , interleukin-6 ( IL-6 ) and interleukin-8 ( IL-8 ) concentrations .
CONCLUSIONS	The proposed study will be the first randomized controlled study to use the polysomnography , which is the gold standard of assessing sleep quality , to evaluate the effect of melatonin on the sleep quality and circadian rhythms of ICU patients .
CONCLUSIONS	The results may recommend a new treatment for ICU patients with sleep deprivation that is safe , effective and easily implementable in daily practice .
BACKGROUND	This study was registered with ClinicalTrials ( NCT ; registration number : ChiCTR-TRC-14004319 ) on 4 March 2013 .

###25011661
BACKGROUND	Various studies have linked the occurrence of cardiovascular events and low ambient temperatures as well as the morning blood pressure surge ( MBPS ) .
BACKGROUND	We hypothesized that low ambient temperatures produce a higher sympathetic change during the last rapid eye movement ( REM ) sleep transition and that this may play an important role in cold-related cardiovascular events .
METHODS	All experiments were carried out on 12 healthy male adults , aged 24.000.74 years , who participated in two experimental conditions randomly ( > 1 day apart ) : warm ( 23 C ) and cold ( 16C ) .
METHODS	Blood pressure ( BP ) was measured every 30 min for 24 h by autonomic ambulatory BP monitoring .
METHODS	The electroencephalograms , electrocardiograms , ambient temperature , near-body temperature , and physical activity were recorded by miniature polysomnography for 24 h.
RESULTS	The cold conditions resulted in : ( i ) higher MBPS than under warm conditions ; ( ii ) significant and greater sympathetic index changes during the sleep-wake transition than during cover-to-uncover and supine-to-sit position tests ; ( iii ) the non-REM-REM transition-related sympathetic elevation during the cold conditions being significantly higher in late sleep period than in early sleep period ; ( iv ) at 1h prior to morning awakening , the value of total power of heart rate variability changes being significantly negatively correlated with the changes of near-body temperature ; and ( v ) significantly higher arousal index and shorter average interval of REM periods than in warm conditions .
CONCLUSIONS	Cold exposure elevates the amplitude of MBPS and is associated with late sleep stage transition sympathetic activation , which might have important implications for cold-related cardiovascular events .

###24735024
BACKGROUND	Dignity therapy is a brief psychotherapy developed for patients living with a life-limiting illness .
OBJECTIVE	To determine the influence of dignity therapy on depression and anxiety in inpatients with a terminal illness and experiencing a high level of distress in a palliative care unit .
METHODS	A nonblinded phase II randomized controlled trial of 80 patients who were randomly assigned to one of two groups : intervention group ( dignity therapy + standard palliative care [ SPC ] ) or control group ( SPC alone ) .
METHODS	The main outcomes were depression and anxiety scores , as measured with the Hospital Anxiety and Depression Scale , and assessed at baseline ( T1 ) , day 4 ( T2 ) , day 15 ( T3 ) , and day 30 ( T4 ) of follow-up .
METHODS	This study is registered with www.controlled-trials.com/ISRCTN34354086 .
RESULTS	Of the final 80 participants , 41 were randomly assigned to SPC and 39 to dignity therapy .
RESULTS	Baseline characteristics were similar between the two groups .
RESULTS	Dignity therapy was associated with a decrease in depression scores ( median , 95 % confidence interval [ CI ] : -4.00 , -6.00 to -2.00 , p < 0.0001 ; -4.00 , -7.00 to -1.00 , p = 0.010 ; -5.00 , -8.00 to -1.00 , p = 0.043 , for T2 , T3 , and T4 , respectively ) .
RESULTS	Dignity therapy was similarly associated with a decrease in anxiety scores ( median , 95 % CI : -3.00 , -5.00 to -1.00 , p < 0.0001 ; -4.00 , -7.00 to -2.00 , p = 0.001 ; -4.00 , -7.00 to -1.00 , p = 0.013 , for T2 , T3 , and T4 , respectively ) .
CONCLUSIONS	Dignity therapy resulted in a beneficial effect on depression and anxiety symptoms in end-of-life care .
CONCLUSIONS	The therapeutic benefit of dignity therapy was sustained over a 30-day period .
CONCLUSIONS	Having established its efficacy , future trials of dignity therapy may now begin , comparing it with other psychotherapeutic approaches within the context of terminal illness .

###25170226
OBJECTIVE	To demonstrate that administering heparanase inhibitor PI-88 at 160 mg/d is safe and promising in reducing hepatocellular carcinoma ( HCC ) recurrence for up to 3 year following curative resection .
METHODS	A total of 143 patients ( 83.1 % of the 172 participants in the phase II study ) participated in the follow-up study .
METHODS	Of these patients , 50 had received no treatment , 48 had received 160 mg/d PI-88 , and 45 had received 250 mg/d PI-88 during the phase II trial .
METHODS	Safety parameters and the following efficacy endpoints were investigated : ( 1 ) time to recurrence ; ( 2 ) disease-free survival ; and ( 3 ) overall survival .
RESULTS	PI-88 at 160 mg/d delayed the onset and frequency of HCC recurrence , and provided a clinically significant survival advantage for up to 3 years after treatment compared with those of the control group : ( 1 ) the recurrence-free rate increased from 50 % to 63 % , and ( 2 ) time to recurrence at the 36th percentile was postponed by 78 % .
RESULTS	The efficacy of administering PI-88 at 250 mg/d was confounded by a high dropout rate ( 11 out of 54 patients ) .
RESULTS	Additionally , subgroup analyses of patients with ( 1 ) multiple tumors or a single tumor 2 cm ; and ( 2 ) hepatitis B or C revealed that administering PI-88 at 160 mg/d conferred the most significant survival advantage ( 56.8 % improvement in disease-free survival , P = 0.045 ) for patients with both risk factors for recurrence .
CONCLUSIONS	Administering PI-88 at 160 mg/d is a safe and well-tolerated dosage that may confer significant clinical benefits for patients with HCC .

###24811145
BACKGROUND	A computerized Intervention-Management-System ( IMS ) has been developed and implemented to facilitate dementia care management .
BACKGROUND	IMS is a rule-based expert decision support system that matches individual patient characteristics to a computerized knowledge base .
BACKGROUND	One of the most important functionalities of IMS is to support the compilation of the individual intervention plan by systematically identifying unmet needs and suggesting the corresponding specific interventions for recommendation to the general practitioner ( GP ) .
BACKGROUND	The present analysis aimed to determine if the implementation of IMS improves the identification of unmet needs and the recommendation of adequate specific interventions .
BACKGROUND	In addition , the feasibility and acceptability of the IMS were evaluated .
METHODS	Delphi-MV is an on-going GP-based , cluster-randomized , controlled intervention trial to implement and evaluate a collaborative dementia care management program for community-dwelling PWDs and their caregivers .
METHODS	IMS was developed and implemented over the course of the DelpHi-trial .
METHODS	The identified unmet needs and the interventions that were recommended to the GP before and after the implementation of IMS were compared .
METHODS	To evaluate the feasibility and acceptability of the IMS , a survey was conducted among the current users of IMS .
CONCLUSIONS	After the implementation of IMS , the number of specific interventions recommended to the GP increased by 85 % .
CONCLUSIONS	Our findings provide evidence that IMS improves the systematic identification of unmet needs and the subsequent recommendation of interventions to address these needs .
CONCLUSIONS	The users evaluated IMS as very helpful and would like to use it for their future work .
CONCLUSIONS	However , the usability could be further improved .

###26356615
OBJECTIVE	To compare clinical and morphological results of treatment of ischemic stroke in three groups of patients which differed by the forms and duration of an antioxidant therapy .
METHODS	A randomized clinical trial was performed in 8 vascular centers of the Russian Federation in 2010-2014 .
METHODS	It included 373 patients with ischemic stroke in the carotid territory .
METHODS	Patients were randomized into 3 groups to receive different regimens of antioxidant therapy as an adjunct to standard therapy : control group ( ascorbic acid ; 132 patients ) ; cytoflavin ( 20 ml per day for 10 days ; 133 patients ) ; cytoflavin ( the dose was decreased to 10 ml per day from 11th to 20th day ) ( 108 patients ) .
METHODS	Patient 's condition was assessed in 1 , 10 and 21 day by a complex of clinical , laboratory and instrumental methods .
CONCLUSIONS	The analysis of CT in 1th and 21th day revealed a significant 1,5-1 ,7 - fold decrease in the cerebral ischemic lesion in both groups treated with cytoflavin with no significant morphologic changes in the ascorbic acid group .
CONCLUSIONS	The percentage of patients with ischemic lesion , increased during days 1-21 , was 2-fold higher in the ascorbic acid group compared to cytoflavin groups .
CONCLUSIONS	Morphologic changes were correlated with clinical variables and outcome .
CONCLUSIONS	In patients with 14 points on NIH scale on admission , prolonged 20 day cytoflavin therapy was associated with a more prominent improvement of neurologic , functional and cognitive status compared to 10-day cytoflavin infusion .
CONCLUSIONS	No differences in clinical variables were observed in patients with mild symptoms ( < 14 points on NIH scale on admission ) receiving cytoflavin for 10 and 20 days .

###24980836
BACKGROUND	Secondary arm lymphoedema continues to affect at least 20 % of women after treatment for breast cancer requiring lifelong professional treatment and self-management .
BACKGROUND	The holistic practice of yoga may offer benefits as an adjunct self-management option .
BACKGROUND	The aim of this small pilot trial was to gain preliminary data to determine the effect of yoga on women with stage one breast cancer-related lymphoedema ( BCRL ) .
BACKGROUND	This paper reports the results for the primary and secondary outcomes .
METHODS	Participants were randomised , after baseline testing , to receive either an 8-week yoga intervention ( n = 15 ) , consisting of a weekly 90-minute teacher-led class and a 40-minute daily session delivered by DVD , or to a usual care wait-listed control group ( n = 13 ) .
METHODS	Primary outcome measures were : arm volume of lymphoedema measured by circumference and extra-cellular fluid measured by bioimpedance spectroscopy .
METHODS	Secondary outcome measures were : tissue induration measured by tonometry ; levels of sensations , pain , fatigue , and their limiting effects all measured by a visual analogue scale ( VAS ) and quality of life based on the Lymphoedema Quality of Life Tool ( LYMQOL ) .
METHODS	Measurements were conducted at baseline , week 8 ( post-intervention ) and week 12 ( four weeks after cessation of the intervention ) .
RESULTS	At week 8 , the intervention group had a greater decrease in tissue induration of the affected upper arm compared to the control group ( p = 0.050 ) , as well as a greater reduction in the symptom sub-scale for QOL ( p = 0.038 ) .
RESULTS	There was no difference in arm volume of lymphoedema or extra-cellular fluid between groups at week 8 ; however , at week 12 , arm volume increased more for the intervention group than the control group ( p = 0.032 ) .
CONCLUSIONS	An 8-week yoga intervention reduced tissue induration of the affected upper arm and decreased the QOL sub-scale of symptoms .
CONCLUSIONS	Arm volume of lymphoedema and extra-cellular fluid did not increase .
CONCLUSIONS	These benefits did not last on cessation of the intervention when arm volume of lymphoedema increased .
CONCLUSIONS	Further research trials with a longer duration , higher levels of lymphoedema and larger numbers are warranted before definitive conclusions can be made .

###26255474
OBJECTIVE	To evaluate effects of different treatments on patients with osteoporotic vertebral fracture after percutaneous kyphoplasty in pain and function .
METHODS	From March 2010 to March 2012,138 patients ( 165 vertebrae ) with thoracic and lumbar vertebral osteoporotic fracture were randomly divided into three groups ( control group , treatment group and comprehensive group ) , 46 cases in each group , and all patients were treated by PKP .
METHODS	Control group were treated with calcium and calcitriol after operation , treatment group added salmon calcitonin see calcimar based on control group , comprehensive group added incrementality waist musculi dorsi function exercise based on treatment group .
METHODS	VAS , ODI scores and BMD before operation , 3 d , 2 weeks , 1 month , 6 months and 12 months after operation were detected and compared .
RESULTS	All operation were performed successfully ,38 cases ( 45 vertebrae ) in control group , 36 cases ( 44 vertebrae ) in treatment group and 40 cases ( 49 vertebrae ) were obtained complete following up , there was no significant meaning in following time among three groups ( P > 0.05 ) .
RESULTS	Postoperative VAS and ODI scores at 3 d , 2 weeks and 1 month among three groups were lower than that of before operation ( P < 0.01 ) .
RESULTS	Compared with control group , postoperative VAS score at 3 d , 2 weeks and 1 month were decreasedin treatment group and comprehensive group , but there was no significant meaning in ODI scores ( P > 0.05 ) .
RESULTS	At 6 and 12 months after operation , there was no significant differences in VAS and ODI between control group and treatment group ( P > 0.05 ) , while VAS score in comprehensive group decreased much than other two groups , decreased continuously ( P < 0.01 ) .
RESULTS	At 12 months after operation , BMD among three groups were increased more than preoperative , and BMD in comprehensive group was more obviously than that of in control and treatment group .
CONCLUSIONS	PKP , an effective method for the treatment of thoracic and lumbar vertebral osteoporotic fracture , could improve short-term clinical effects by adding calcitonin with calcium supplements and activated vitamin D. Waist musculi dorsi function exercise could improve long-term clinical effects of PKP and improve quality of life .

###24314186
OBJECTIVE	The purpose of this study was to compare the efficacy of orally administered propranolol versus prednisolone versus both in the treatment of potentially disfiguring or functionally threatening infantile hemangiomas .
METHODS	A prospective study of 30 patients aged 1 week-8 months was randomized into three equal groups .
METHODS	These were as follows : A , propranolol ( 2-3 mg/kg/d ) ; B , prednisolone ( 1-4 mg/kg/d ) ; and C , receiving both for a minimum duration of 3 months .
METHODS	Dimensions , color , consistency , ultrasonography , photographic documentation based on Visual Analogue Scale ( VAS ) were recorded before and periodically after starting treatment .
METHODS	A minimum 75 % improvement was considered as success with no regrowth up to 1 month of stopping treatment .
RESULTS	Mean initial response time ( days ) in A ( 4.13.3 SD ) and C ( 4.73.4 SD ) was significantly lower than B ( 9.787.8 SD ) ( p < 0.047 ) .
RESULTS	Significant change in consistency was noted very early in A ( 24 hours ) compared to B and C ( 8 days ) .
RESULTS	VAS results are as follows : ( a ) color fading -- significant reduction in A within 48 hours compared to B and C ( p = 0.025 ) , ( b ) flattening -- more significant and earlier in A and C than B ( p < 0.05 ) , and ( c ) mean reduction in size : significant in A and C at 3 months ( p = 0.005 , p = 0.005 ) , 6 months ( p = 0.005 , p = 0.008 ) , 12 months ( p = 0.005 , p = 0.008 ) , and 18 months ( p = 0.02 , p = 0.04 ) , whereas in B , it was seen only at 6 months ( p = 0.008 ) .
CONCLUSIONS	Propranolol had a consistent , rapid therapeutic effect compared to prednisolone .
CONCLUSIONS	A combination of the two had a comparable but not higher efficacy than propranolol alone .
CONCLUSIONS	Prednisolone was associated with a higher number of complications , thereby decreasing patient compliance .

###24901753
OBJECTIVE	This study aimed to evaluate the effectiveness of transcutaneous electrical nerve stimulation ( TENS ) for treatment of postoperative pain and pulmonary functions ( vital capacity [ VC ] ; cough peak flow , [ CPF ] ) in patients who underwent abdominal surgery .
METHODS	Forty-eight patients were randomly allocated to receive TENS , placebo TENS , or no TENS ( control ) 1 hour a day for 3 days postoperatively .
METHODS	A 0-100 visual analog scale was used to assess pain at preintervention , mid-intervention , and postintervention on the third postoperative day .
METHODS	Pulmonary functions ( VC , CPF ) were evaluated by spirometer at preoperation ( baseline ) and at preintervention , mid-intervention , and postintervention on the third postoperative day .
METHODS	One-way analysis of variance was used to assess differences between groups at baseline .
METHODS	Mann-Whitney test was used to compare the control group with the placebo-TENS and TENS group , at each assessment timepoint .
METHODS	Two-way analysis of variance and Bonferroni post hoc test assessed the difference between the 2 ( placebo-TENSTENS ) groups .
METHODS	A value of P < 0.01 was considered statistically significant .
RESULTS	The baselines were not significantly different between any groups .
RESULTS	The TENS group had significant reductions in postoperative pain compared with the placebo group ( P < 0.01 ) and control group ( P < 0.01 ) .
RESULTS	There was also improvement in pulmonary functions ( VC , CPF ) at mid-TENS and post-TENS , but not in the placebo-TENS ( P < 0.01 ) or control groups ( P < 0.01 ) .
CONCLUSIONS	TENS is a valuable treatment to alleviate postoperative pain and improve pulmonary functions ( ie , VC , CPF ) in patients following abdominal surgery .

###25036199
OBJECTIVE	Cerebrospinal fluid leakage is an immanent risk of cranial surgery with dural opening .
OBJECTIVE	Recognizing the risk factors for this complication and improving the technique of dural closure may reduce the associated morbidity and its surgical burden .
OBJECTIVE	The aim of this paper was to investigate whether the addition of TachoSil on top of the dural suture reduces postoperative CSF leakage compared with dural suturing alone and to assess the frequency and risk factors for dural leakage and potentially related complications after elective craniotomy .
METHODS	The authors conducted a prospective , randomized , double-blinded single-center trial in patients undergoing elective craniotomy with dural opening .
METHODS	They compared their standard dural closure by running suture alone ( with the use of a dural patch if needed ) to the same closure with the addition of TachoSil on top of the suture .
METHODS	The primary end point was the incidence of CSF leakage , defined as CSF collection or any open CSF fistula within 30 days .
METHODS	Secondary end points were the incidence of infection , surgical revision , and length of stay in the intensive care unit ( ICU ) or intermediate care ( IMC ) unit .
METHODS	The site of craniotomy , a history of diabetes mellitus , a diagnosis of meningioma , the intraoperative need of a suturable dural substitute , and blood parameters were assessed as potential risk factors for CSF leakage .
RESULTS	The authors enrolled 241 patients , of whom 229 were included in the analysis .
RESULTS	Cerebrospinal fluid leakage , mostly self-limiting subgaleal collections , occurred in 13.5 % of patients .
RESULTS	Invasive treatment was performed in 8 patients ( 3.5 % ) ( subgaleal puncture in 6 , lumbar drainage in 1 , and surgical revision in 1 patient ) .
RESULTS	Diabetes mellitus , a higher preoperative level of C-reactive protein ( CRP ) , and the intraoperative need for a dural patch were positively associated with the occurrence of the primary end point ( p = 0.014 , 0.01 , and 0.049 , respectively ) .
RESULTS	Cerebrospinal fluid leakage ( 9.7 % vs 17.2 % , OR 0.53 [ 95 % CI 0.23-1 .15 ] , p = 0.108 ) and infection ( OR 0.18 [ 95 % CI 0.01-1 .18 ] , p = 0.077 ) occurred less frequently in the study group than in the control group .
RESULTS	TachoSil significantly reduced the probability of staying in the IMC unit for 1 day or longer ( OR 0.53 [ 95 % CI 0.27-0 .99 ] , p = 0.048 ) .
RESULTS	Postoperative epidural hematoma and empyema occurred in the control group but not in the study group .
CONCLUSIONS	Dural leakage after elective craniotomy/durotomy occurs more frequently in association with diabetes mellitus , elevated preoperative CRP levels , and the intraoperative need of a dural patch .
CONCLUSIONS	This randomized controlled trial showed no statistically significant reduction of postoperative CSF leakage and surgical site infections upon addition of TachoSil on the dural suture , but there was a significant reduction in the length of stay in the IMC unit .
CONCLUSIONS	Dural augmentation with TachoSil was safe and not related to adverse events .
CONCLUSIONS	Clinical trial registration no .
CONCLUSIONS	NCT00999999 ( http://www.ClinicalTrials.gov ) .

###25185255
OBJECTIVE	To assess over a 36-month period functional results of the modified INTRACOR femtosecond laser-based intrastromal procedure to treat presbyopia .
METHODS	20 eyes of 20 presbyopic patients with mild hyperopia were included .
METHODS	The INTRACOR procedure with a modified pattern ( six concentric intrastromal ring cuts ) was performed using the FEMTEC femtosecond laser ( Bausch + Lomb/Technolas Perfect Vision , Munich , Germany ) .
METHODS	Patients were also randomly divided into three subgroups to compare the effect of three different small inner ring diameters ( 1.8 / 2.0 / 2.2 mm ( Groups A/B/C ) ) .
METHODS	Follow-up examinations were performed at 1 , 3 , 6 , 12 , 24 and 36months , and included near and distance visual acuity tests , slit-lamp examinations and corneal topography .
RESULTS	Median uncorrected near visual acuity ( UNVA ) increased from 0.7 / 0.7 / 0.7 logMAR ( Groups A/B/C ) to -0.1 / 0.1 / 0.1 logMAR 36months after surgery .
RESULTS	Uncorrected distance visual acuity changed slightly from 0.1 / 0.2 / 0.1 logMAR to 0.2 / 0.3 / 0.1 logMAR .
RESULTS	Losses of two lines of binocular corrected distance visual acuity ( CDVA ) were noted in 0/25/0 % of eyes .
RESULTS	Median spherical equivalent changed from 0.75 / 0.75 / 0.75 dioptres to -0.19 / 0.13 / -0.19 dioptres .
RESULTS	Overall patient satisfaction with the procedure was 80 % .
CONCLUSIONS	INTRACOR with a modified pattern improved UNVA in all patients over a 36-month follow-up period .
CONCLUSIONS	The possibility of reduced CDVA underlines the need for careful patient selection .
BACKGROUND	NCT00928122 .

###25632576
OBJECTIVE	To observe the effect of medicinal-cake-separated moxibustion combined with acupuncture on back-leg activities and plasma substance P ( SP ) levels in patients with lumbar disc herniation , so as to reveal its mechanism underlying pain relief .
METHODS	A total of 114 patients with lumbar disc herniation were randomly divided into control group ( n = 56 ) and treatment group ( n = 58 ) according to a random digits table .
METHODS	Patients of the control group were treated by manual acupuncture stimulation of main acupoints Jiaji ( EX-B 2 ) , Huantiao ( GB 30 , affected side ) , Chengshan ( BL 57 , affected side ) , Kunlun ( BL 60 , affected side ) , and supplemented acupoints Yanglingquan ( GB 34 ) , Weizhong ( BL 40 ) and Zusanli ( ST 36 ) in combination with wheat-flour-cake separated moxibustion at the main acupoints , and patients of the treatment group were treated by medicinal-cake [ Chuanwu ( Radix Aconiti ) , Caowu ( Radix Aconiti Kusnezoffii ) , Ruxiang ( Olibanum ) , etc. ] - separated moxibustion in combination with manual acupuncture stimulation of the same acupoints mentioned above .
METHODS	Acupuncture treatment was conducted for 30 min , followed by moxibustion for 15 min .
METHODS	The treatment was given once daily for 10 days .
METHODS	The patients ' back-leg functional activity ability was assessed using straight-leg raising test , and the pain state assessed using visual analogue scale ( VAS ) and Japanese Orthopaedic Association ( JOA ) scores , respectively .
METHODS	The therapeutic effect was evaluated by using `` Crite - ria for Diagnosis and Outcome Evaluation of Clinical Disorders or Syndromes of Chinese Medicine '' issued in 1994 and plasma SP content was detected by radioimmunoassay .
RESULTS	After the therapy , the back-leg activity score and JOA score of both groups were significantly higher than those of pre-treatment in the same one group ( P < 0.05 , P < 0.01 ) , and those of the treatment group were significantly higher than those of the control group ( P < 0.05 ) .
RESULTS	The VAS score of the treatment group was re - markably lower than that of the control group ( P < 0.01 ) .
RESULTS	After the treatment , the plasma SP content was markedly lower in the treatment group than in the control group ( .
RESULTS	P < 0O .
RESULTS	05 ) .
CONCLUSIONS	Medicinal-cake-separated moxibustion therapy can ame - liorate pain severity and functional activity of the back-leg pain patients with lumbar disc hernia , which may be related to its effect in reducing blood SP level .

###24758073
OBJECTIVE	To evaluate the efficacy and safety of etanercept plus Tripterygium wilfordii polyglycoside ( TWP ) in elderly patients with active rheumatoid arthritis ( RA ) .
METHODS	Totally 46 elderly patients with active RA were randomly assigned to the treatment group ( 22 cases ) and the control group ( 24 cases ) .
METHODS	All patients received subcutaneous injection of etanercept , 25 mg each time , twice per week .
METHODS	The dosage was reduced to once per week 3 months later .
METHODS	Patients in the treatment group took TWP Tablet ( 10 mg each time , three times per day ) , while those in the control group took methotrexate ( MTX ) , 10 mg each time , once per week .
METHODS	The whole course lasted for 24 weeks .
METHODS	Patients ' rest pain , tender joint number , swollen joint number , health assessment questionnaire ( HAQ ) , patients ' global assessment , physicians ' global assessment , erythrocyte sediment rate ( ESR ) , C reactive protein ( CRP ) , rheumatic factor were assessed at week 0 , 4 , 8 , 12 , and 24 .
METHODS	The curative effect was statistically evaluated by the United States Institute of Rheumatology ACR20 , ACR50 , and ACR70 improvement criteria .
METHODS	Meanwhile , any adverse event was recorded and evaluated .
RESULTS	Totally 41 completed the trial , and 5 dropped off ( 3 in the treatment group and 2 in the control group ) .
RESULTS	Compared with the control group , there was no statistical difference in ACR20 , ACR50 , or ACR70 in the treatment group ( P > 0.05 ) .
RESULTS	Compared with before treatment in the same group , there was some improvement in tender joint number , swollen joint number , visual analogue scale ( VAS ) for patients ' global assessment , VAS for physicians ' global assessment , ESR , CRP , and HAQ between the two groups , showing statistical difference ( P < 0.05 ) .
RESULTS	Compared with the control group in the same phase , there was no statistical difference in the treatment group ( P > 0.05 ) .
RESULTS	There was no statistical difference in the occurrence of adverse events between the two groups .
CONCLUSIONS	Etanercept plus TWP could achieve equivalent therapeutic effect to that of Etanercept plus MTX .
CONCLUSIONS	The two regimens could improve clinical signs , symptoms , and QOL related to RA .
CONCLUSIONS	They were well tolerated in the treatment of elderly patients with active RA .

###25387438
BACKGROUND	Proficiency and self-confidence in the physical examination is poor among internal medicine residents and interest in ultrasound technology has expanded .
OBJECTIVE	We aimed to determine whether a pocket-sized ultrasound improves the diagnostic accuracy and confidence of residents after a 3-h training session and 1 month of independent practice .
METHODS	This was a randomized parallel group controlled trial .
METHODS	Forty internal medicine residents in a single program at an academic medical center participated in the study .
METHODS	Three hours of training on use of pocket-sized ultrasound was followed by 1 month of independent practice .
METHODS	The primary outcome was a comparison of the diagnostic accuracy of a physical exam alone versus a physical examination augmented with a pocket-sized ultrasound .
METHODS	Other outcomes included confidence in exam findings and a survey of attitudes towards the physical exam and the role of ultrasound .
RESULTS	Residents in the intervention group using a pocket-sized ultrasound correctly identified an average of 7.6 of the 17 abnormal findings ( accuracy rate of 44.9 % ) .
RESULTS	Those in the control group correctly identified an average of 6.4 abnormal findings ( accuracy rate of 37.6 % , p = 0.11 ) .
RESULTS	Residents in the intervention group identified on average 15.9 findings as abnormal when no abnormality existed ( false positive rate of 16.8 % ) .
RESULTS	Those in the control group incorrectly identified an average of 15.5 positive findings ( false positive rate of 16.3 % ) .
RESULTS	There was no difference between groups regarding self-assessed confidence in physical examination .
RESULTS	Residents in the intervention group identified 6.1 of 13 abnormal cardiac findings versus the control group 's 4.5 of 13 , an accuracy rate of 47.0 % versus 34.6 % ( p = 0.023 ) .
CONCLUSIONS	The diagnostic ability of internal medicine residents did not significantly improve with use of a pocket-sized ultrasound device after a 3-h training session and 1 month of independent practice .
BACKGROUND	clinicaltrials.gov : number NCT01948076 ; URL http://clinicaltrials.gov/ct2/show/study/NCT01948076?term=ultrasound+physical+exam&rank=2 .

###25517477
OBJECTIVE	To evaluate whether using long-axis or short-axis view during ultrasound-guided internal jugular and subclavian central venous catheterization results in fewer skin breaks , decreased time to cannulation , and fewer posterior wall penetrations .
METHODS	Prospective , randomized crossover study .
METHODS	Urban emergency department with approximate annual census of 60,000 .
METHODS	Emergency medicine resident physicians at the Denver Health Residency in Emergency Medicine , a postgraduate year 1-4 training program .
METHODS	Resident physicians blinded to the study hypothesis used ultrasound guidance to cannulate the internal jugular and subclavian of a human torso mannequin using the long-axis and short-axis views at each site .
RESULTS	An ultrasound fellow recorded skin breaks , redirections , and time to cannulation .
RESULTS	An experienced ultrasound fellow or attending used a convex 8-4 MHz transducer during cannulation to monitor the needle path and determine posterior wall penetration .
RESULTS	Generalized linear mixed models with a random subject effect were used to compare time to cannulation , number of skin breaks and redirections , and posterior wall penetration of the long axis and short axis at each cannulation site .
RESULTS	Twenty-eight resident physicians participated : eight postgraduate year 1 , eight postgraduate year 2 , five postgraduate year 3 , and seven postgraduate year 4 .
RESULTS	The median ( interquartile range ) number of total internal jugular central venous catheters placed was 27 ( interquartile range , 9-42 ) and subclavian was six catheters ( interquartile range , 2-20 ) .
RESULTS	The median number of previous ultrasound-guided internal jugular catheters was 25 ( interquartile range , 9-40 ) , and ultrasound-guided subclavian catheters were three ( interquartile range , 0-5 ) .
RESULTS	The long-axis view was associated with a significant decrease in the number of redirections at the internal jugular and subclavian sites , relative risk 0.4 ( 95 % CI , 0.2-0 .9 ) and relative risk 0.5 ( 95 % CI , 0.3-0 .7 ) , respectively .
RESULTS	There was no significant difference in the number of skin breaks between the long axis and short axis at the subclavian and internal jugular sites .
RESULTS	The long-axis view for subclavian was associated with decreased time to cannulation ; there was no significant difference in time between the short-axis and long-axis views at the internal jugular site .
RESULTS	The prevalence of posterior wall penetration was internal jugular short axis 25 % , internal jugular long axis 21 % , subclavian short axis 64 % , and subclavian long axis 39 % .
RESULTS	The odds of posterior wall penetration were significantly less in the subclavian long axis ( odds ratio , 0.3 ; 95 % CI , 0.1-0 .9 ) .
CONCLUSIONS	The long-axis view for the internal jugular was more efficient than the short-axis view with fewer redirections .
CONCLUSIONS	The long-axis view for subclavian central venous catheterization was also more efficient with decreased time to cannulation and fewer redirections .
CONCLUSIONS	The long-axis approach to subclavian central venous catheterization is also associated with fewer posterior wall penetrations .
CONCLUSIONS	Using the long-axis view for subclavian central venous catheterization and avoiding posterior wall penetrations may result in fewer central venous catheter-related complications .

###26046967
BACKGROUND	IGF-I is thought to mediate many of the anabolic actions of GH , and there are anecdotal reports that IGF-I is misused by elite athletes .
BACKGROUND	There is no published evidence regarding the effects of IGF-I administration on athletic performance .
OBJECTIVE	The objective of the study was to investigate the effects of IGF-I administration on body composition and physical fitness in recreational athletes .
METHODS	This was a randomized , double-blind , placebo-controlled recombinant human ( rh ) IGF-I/rhIGF binding protein ( IGFBP ) -3 administration study at Southampton General Hospital ( Southampton , United Kingdom ) .
METHODS	Fifty-six recreational athletes ( 30 men , 26 women ) participated in the study .
METHODS	Participants were randomly assigned to receive placebo , low-dose rhIGF-I/rhIGFBP -3 ( 30 mg/d ) , or high dose rhIGF-I/rhIGFBP -3 ( 60 mg/d ) for 28 days .
METHODS	Body composition ( assessed by dual energy x-ray absorptiometry ) and cardiorespiratory fitness ( assessed by incremental treadmill test ) were measured before and immediately after treatment .
METHODS	Within-individual changes after treatment were analyzed using paired t tests .
RESULTS	There were no significant changes in body fat mass or lean body mass in women or men after the administration of the rhIGF-I/rhIGFBP -3 complex .
RESULTS	There was a significant increase in maximal oxygen consumption ( VO2 max ) after treatment .
RESULTS	When women and men and low - and high-dose treatment groups were combined , mean VO2 max increased by approximately 7 % ( P = .001 ) .
RESULTS	No significant change in VO2 max was observed in the placebo group .
CONCLUSIONS	rhIGF-I/rhIGFBP -3 administration for 28 days improves aerobic performance in recreational athletes , but there are no effects on body composition .

###25197737
OBJECTIVE	To compare the effectiveness of conventional and game-based oral health education on the oral health-related knowledge and oral hygiene status among 5 - to 10-year-old schoolchildren .
METHODS	A total of 120 children aged 5 to 10 years were divided into 2 groups .
METHODS	Each group had 30 children aged 5 to 7 years and 30 children aged 8 to 10 years .
METHODS	A pretest evaluation of their knowledge regarding oral health and the estimation of Debris Index-Simplified ( DI-S ) was carried out .
METHODS	Children in group A were given oral health education through flash cards once daily for 7 days .
METHODS	Children in group B were educated through the play method ( i.e. snakes and ladders game combined with flash cards ) .
METHODS	The evaluations regarding oral hygiene and DI-S were recorded on post-intervention day 1 and 3 months after the intervention .
RESULTS	In group B , high knowledge scores of 14.6 and 14.47 were obtained by the 5 - to 7-year-olds and 8 - to 10-yearolds , respectively , on post-intervention day 1 .
RESULTS	The lowest mean percentage difference of 8.9 was seen in 5 - to 7-yearold children of group A after 3 months .
RESULTS	In group B ( 5-7 and 8-10 ) and group A ( 8-10 ) there was a significant increase in good oral hygiene scores and a significant decrease in fair and poor debris scores on post-intervention day 1 and at the 3-month follow-up .
CONCLUSIONS	The knowledge scores of both the younger and older groups of children increased considerably when the game-based teaching intervention was used .
CONCLUSIONS	Hence , it can be an effective aid for teaching basic oral health concepts to children .

###24556095
OBJECTIVE	This single-center , randomized , clinical trial was designed to determine the 10-year comparative efficacy and durability of carotid angioplasty and stenting ( CAS ) versus carotid endarterectomy ( CEA ) in preventing ipsilateral ischemic stroke in symptomatic and asymptomatic patients with high-grade carotid artery stenosis .
BACKGROUND	Modern clinical trials with short-term follow-up indicate CAS and CEA are equivalent in reducing the risk for ipsilateral ischemic stroke secondary to carotid stenosis .
BACKGROUND	A paucity of data exists regarding long-term outcomes .
METHODS	Patients of all surgical risks with symptomatic and asymptomatic carotid stenosis ( > 70 % ) were randomly selected for CEA or CAS and followed a minimum of 10 years .
RESULTS	Long-term follow-up was achieved in 173 patients ( 91 % ) .
RESULTS	Eighty-seven ( 50.2 % ) died within this period , most commonly of nonvascular causes .
RESULTS	No difference in the risk of stroke ipsilateral to the treated artery was noted among treatment groups ( p > 0.05 ) .
RESULTS	Restenosis determined by sequential ultrasound was assessed only in the CAS group ( 3.3 % ) and remained asymptomatic .
RESULTS	The combined risk of fatal or nonfatal heart attack over the 10-year period was highest in individuals with symptomatic versus asymptomatic stenosis ( 27.5 % vs. 11.0 % ; hazard ratio [ HR ] : 2.32 , 95 % confidence interval [ CI ] : 1.298 to 4.146 , p = 0.005 ) and was higher in all patients treated with CEA ( HR : 2.27 , 95 % CI : 1.35 to 3.816 , p = 0.002 ) .
CONCLUSIONS	Long-term protection against ipsilateral stroke provided by CAS and CEA did not differ in this trial .
CONCLUSIONS	The 10-year risk of fatal/nonfatal myocardial infarction was highest in all patients harboring symptomatic carotid stenosis at enrollment .
CONCLUSIONS	The risk of fatal/nonfatal heart attack was significantly more prevalent in those symptomatic or asymptomatic patients randomized to CEA .

###24342421
BACKGROUND	Reductions in drinking among individuals randomised to control groups in brief alcohol intervention trials are common and suggest that asking study participants about their drinking may itself cause them to reduce their consumption .
BACKGROUND	We sought to test the hypothesis that the statistical artefact regression to the mean ( RTM ) explains part of the reduction in such studies .
METHODS	967 participants in a cohort study of alcohol consumption in New Zealand provided data at baseline and again six months later .
METHODS	We use graphical methods and apply thresholds of 8 , 12 , 16 and 20 in AUDIT scores to explore RTM .
RESULTS	There was a negative association between baseline AUDIT scores and change in AUDIT scores from baseline to six months , which in the absence of bias and confounding , is RTM .
RESULTS	Students with lower baseline scores tended to have higher follow-up scores and conversely , those with higher baseline scores tended to have lower follow-up scores .
RESULTS	When a threshold score of 8 was used to select a subgroup , the observed mean change was approximately half of that observed without a threshold .
RESULTS	The application of higher thresholds produced greater apparent reductions in alcohol consumption .
CONCLUSIONS	Part of the reduction seen in the control groups of brief alcohol intervention trials is likely to be due to RTM and the amount of change is likely to be greater as the threshold for entry to the trial increases .
CONCLUSIONS	Quantification of RTM warrants further study and should assist understanding assessment and other research participation effects .

###25298043
BACKGROUND	Clinical trials are increasingly being conducted as new products seek to enter the market .
BACKGROUND	Deployment of such interventions is based on evidence obtained mainly from the gold standard of randomized controlled clinical trials ( RCCT ) .
BACKGROUND	A crucial factor in the ability of RCCTs to provide credible and generalisable data is sample size and retention of the required number of subjects at completion of the follow-up period .
BACKGROUND	However , recruitment and retention in clinical trials are hindered by prevalent peculiar challenges in Africa that need to be circumvented .
BACKGROUND	This article shares experiences from a phase II trial that recorded a high retention rate at 14 months follow-up at a new clinical trial site .
METHODS	Mothers bringing children less than two months of age to the health facility were given information and invited to have their child enrolled if the inclusion criteria were fulfilled .
METHODS	Participants were enrolled over 8 months .
METHODS	Trial procedures , duration and risks/benefits were painstakingly and sequentially explained to the communities , parents and relevant relatives before and during the trial period .
METHODS	The proportions of participants that completed or did not complete the trial were analyzed including the reasons for failure to complete all trial procedures .
RESULTS	1044 individuals received information regarding the trial of which 371 returned for screening .
RESULTS	300 ( 81 % ) of them who fulfilled the inclusion criteria and did not meet any exclusion criteria were enrolled and 94 % of these completed the trial .
RESULTS	Consent withdrawal was the main reason for not completing the trial largely ( 75 % ) due to the father not being involved at the point of consenting or parents no longer being comfortable with blood sampling .
CONCLUSIONS	Participant retention in clinical trials remains a crucial factor in ensuring generalisability of trial data .
CONCLUSIONS	Appropriate measures to enhance retention should include continuous community involvement in the process , adequate explanation of trial procedures and risks/benefits ; and innovative tracing of participants adapted for the setting .

###25326208
BACKGROUND	Symptomatic hip osteoarthritis ( OA ) is a disabling condition with up to a 25 % cumulative lifetime risk .
BACKGROUND	Total hip arthroplasty ( THA ) is effective in relieving patients ' symptoms and improving function .
BACKGROUND	It is , however , associated with substantial risk of complications , pain and major functional limitation before patients can return to full function .
BACKGROUND	In contrast , hip arthroscopy ( HA ) is less invasive and can postpone THA .
BACKGROUND	However , there is no evidence regarding the delay in the need for THA that patients would find acceptable to undergoing HA .
BACKGROUND	Knowing patients ' values and preferences ( VP ) on this expected delay is critical when making recommendations regarding the advisability of HA .
BACKGROUND	Furthermore , little is known on the optimal amount of information regarding interventions and outcomes needed to present in order to optimally elicit patients ' VP .
METHODS	We will perform a multinational , structured interview-based survey of preference in delay time for THA among patients with non-advanced OA who failed to respond to conservative therapy .
METHODS	We will combine these interviews with a randomised trial addressing the optimal amount of information regarding the interventions and outcomes required to elicit preferences .
METHODS	Eligible patients will be randomly assigned ( 1:1 ) to either a short or a long format of health scenarios of THA and HA .
METHODS	We will determine each patient 's VP using a trade-off and anticipated regret exercises .
METHODS	Our primary outcomes for the combined surveys will be : ( 1 ) the minimal delay time in the need for THA surgery that patients would find acceptable to undertaking HA , ( 2 ) patients ' satisfaction with the amount of information provided in the health scenarios used to elicit their VPs .
BACKGROUND	The protocol has been approved by the Hamilton Integrated Research Ethics Board ( HIREB13-506 ) .
BACKGROUND	We will disseminate our study findings through peer-reviewed publications and conference presentations , and make them available to guideline makers issuing recommendations addressing HA and THA .

###25491556
BACKGROUND	From 2000 to 2012 , the annual incidence of inpatient treatment for distal radius fracture in Germany rose from 65 to 86 per 100 000 persons .
BACKGROUND	It is unclear whether open reduction and volar angle-stable plate osteosynthesis ( ORIF ) , a currently advocated treatment , yields a better functional outcome or quality of life than closed reposition and casting .
METHODS	In the ORCHID multi-center trial , 185 patients aged 65 and older with an AO type C distal radial fracture were randomly assigned to ORIF or closed reposition and casting .
METHODS	Their health-related quality of life and hand/arm function were assessed 3 and 12 months afterward with the Short Form 36 ( SF-36 ) questionnaire and the Disability of the Arm , Shoulder and Hand ( DASH ) questionnaire .
METHODS	The radiological findings , range of movement of the wrist , and EuroQol-5D ( EQ-5D ) scores were documented as well .
RESULTS	Among the 149 patients in the intention-to-treat-analysis , there was no significant difference in SF-36 scores between the two treatment groups at one year ( mean difference , 3.3 points in favor of ORIF ; 95 % confidence interval , -0.2 +6.8 points ; p = 0.058 ) .
RESULTS	The DASH scores showed moderately strong , but clinically unimportant effects in favor of ORIF , and there was no difference in EQ-5D scores .
RESULTS	ORIF led to better radiological results and wrist mobility at 3 months , with comparable results at 12 months .
RESULTS	37 of the patients initially allotted to nonsurgical treatment underwent secondary surgery due to significant loss of reduction .
CONCLUSIONS	The findings with respect to mobility , functionality , and quality of life at 12 months provide marginal and inconsistent evidence for the superiority of volar angle-stable plate osteosynthesis over closed reduction and casting in the treatment of intra-articular distal radius fractures .
CONCLUSIONS	Primary nonsurgical management is also effective in suitable patients .

###25732165
OBJECTIVE	Secondary acute myeloid leukemia ( sAML ) , defined as AML arising after a prior myelodysplastic syndrome or after antineoplastic therapy , responds poorly to current therapies .
OBJECTIVE	It is often associated with adverse karyotypic abnormalities and overexpression of proteins that mediate drug resistance .
OBJECTIVE	We performed a phase III trial to determine whether induction therapy with cytarabine and amonafide L-malate , a DNA intercalator and non-ATP-dependent topoisomerase II inhibitor that evades drug resistance mechanisms , yielded a superior complete remission rate than standard therapy with cytarabine and daunorubicin in sAML .
METHODS	Patients with previously untreated sAML were randomly assigned at a one-to-one ratio to cytarabine 200 mg/m ( 2 ) continuous intravenous ( IV ) infusion once per day on days 1 to 7 plus either amonafide 600 mg/m ( 2 ) IV over 4 hours on days 1 to 5 ( A + C arm ) or daunorubicin 45 mg/m ( 2 ) IV over 30 minutes once per day on days 1 to 3 ( D + C arm ) .
RESULTS	The complete remission ( CR ) rate was 46 % ( 99 of 216 patients ) in A + C arm and 45 % ( 97 of 217 patients ) in D + C arm ( P = .81 ) .
RESULTS	The 30 - and 60-day mortality rates were 19 % and 28 % in A + C arm and 13 % and 21 % in D + C arm , respectively .
CONCLUSIONS	Induction treatment with A + C did not improve the CR rate compared with D + C in patients with sAML .

###26087570
OBJECTIVE	To investigate the clinical efficacy of three toothpastes in controlling established gingivitis and plaque over 6 months .
METHODS	135 subjects were enrolled in a single-center , double-blind , parallel group , randomized clinical study .
METHODS	Subjects were randomly assigned to one of three treatments : triclosan/copolymer/fluoride dentifrice containing 0.3 % triclosan , 2.0 % copolymer and 1,450 ppm F as sodium fluoride in a silica base ; herbal/bicarbonate dentifrice containing herbal extract and 1,400 ppm F as sodium fluoride in a sodium bicarbonate base ; or fluoride dentifrice containing 450 ppm F as sodium fluoride , and 1,000 ppm F as sodium monofluorophosphate .
METHODS	Subjects were instructed to brush their teeth twice daily for 1 minute for 6 months .
RESULTS	After 6 months , subjects assigned to the triclosan/copolymer/fluoride group exhibited statistically significant reductions in gingival index scores and plaque index scores as compared to subjects assigned to the herbal/bicarbonate group by 35.4 % and 48.9 % , respectively .
RESULTS	There were no statistically significant differences in gingival index and plaque index between subjects in the herbal / bicarbonate group and those in the fluoride group .
RESULTS	The triclosan/copolymer/fluoride dentifrice was statistically significantly more effective in reducing gingivitis and dental plaque than the herbal/bicarbonate dentifrice , and this difference in efficacy was clinically meaningful .

###25039610
BACKGROUND	Although asthma is characterized by variable airways obstruction , most studies of asthma phenotypes are cross-sectional .
BACKGROUND	The stability of phenotypes defined either by biomarkers or by physiological variables was assessed by repeated measures over 1year in the Pan-European BIOAIR cohort of adult asthmatics .
METHODS	A total of 169 patients , 93 with severe asthma ( SA ) and 76 with mild-to-moderate asthma ( MA ) , were examined at six or more visits during 1year .
METHODS	Asthma phenotype clusters were defined by physiological variables ( lung function , reversibility and age of onset of the disease ) or by biomarkers ( eosinophils and neutrophils in induced sputum ) .
RESULTS	After 1year of follow-up , the allocation to clusters was changed in 23.6 % of all asthma patients when defined by physiological phenotypes and , remarkably , in 42.3 % of the patients when stratified according to sputum cellularity ( P = 0.034 ) .
RESULTS	In the SA cohort , 30 % and 48.6 % of the patients changed allocation according to physiological and biomarker clustering , respectively .
RESULTS	Variability of phenotypes was not influenced by change in oral or inhaled corticosteroid dose , nor by the number of exacerbations .
RESULTS	Lower stability of single and repeated measure was found for all evaluated biomarkers ( eosinophils , neutrophils and FeNO ) in contrast to good stability of physiological variables ( FEV1 ) , quality of life and asthma control .
CONCLUSIONS	Phenotypes determined by biomarkers are less stable than those defined by physiological variables , especially in severe asthmatics .
CONCLUSIONS	The data also imply that definition of asthma phenotypes is improved by repeated measures to account for fluctuations in lung function , biomarkers and asthma control .

###26000501
OBJECTIVE	To investigate women 's understanding of prenatal testing options and of their own experience with screening , diagnostic genetic testing , or both .
METHODS	This was a secondary analysis of data from a randomized controlled trial of enhanced information and values clarification regarding prenatal genetic testing in the absence of financial barriers to testing .
METHODS	Women in the third trimester of pregnancy were asked whether they had discussed prenatal genetic testing with their health care providers , whether they understood this testing was optional , and whether they had undergone testing during their pregnancy .
METHODS	Multivariable logistic regression models were fit to determine independent predictors of these outcomes .
RESULTS	Data were available from 710 study participants .
RESULTS	Discussions about screening tests were reported by 654 participants ( 92 % ) ; only 412 ( 58 % ) reported discussing diagnostic testing .
RESULTS	That screening and diagnostic testing were optional was evident to approximately two thirds of women ( n = 470 and 455 , respectively ) .
RESULTS	Recall of actual tests undergone was correct for 626 ( 88 % ) for screening and for 700 ( 99 % ) for diagnostic testing .
RESULTS	Racial , ethnic and socioeconomic variation existed in the understanding of whether screening and diagnostic tests were optional and in the correct recall of whether screening had been undertaken in the current pregnancy .
RESULTS	In the usual care group , women receiving care in low-income settings were less likely to recall being offered diagnostic testing ( adjusted odds ratio 0.23 [ 0.14-0 .39 ] ) .
CONCLUSIONS	Disparities exist in women 's recall of prenatal genetic testing discussions and their understanding of their own experience .
CONCLUSIONS	Interventions that explain testing options to women and help clarify their preferences may help to eliminate these differences .

###24766817
BACKGROUND	New antithrombotic drugs for prevention and treatment of thromboembolic disorders in AF that are less demanding on local staff and facilities than warfarin should be welcomed if proved successful .
OBJECTIVE	The comparative value and possible dangers of substituting the new drug dabigatran as a replacement remain to be established .
OBJECTIVE	Its safety and effectiveness must be reviewed and assessed by further study .
METHODS	Clinical results of the European Action on Anticoagulation ( EAA ) computer-assisted dosage study and the Randomized Evaluation of Long-Term Anticoagulation Therapy ( RE-LY ) trial have been compared .
RESULTS	Clinical events were lower in patients on warfarin in the EAA study compared to patients on both warfarin and dabigatran in the RE-LY study .
CONCLUSIONS	Evaluations should recognize optimum requirements for safe and effective administration of both types of drug .
CONCLUSIONS	In the warfarin arm improvements in effectiveness and safety recently introduced ( i.e. the PT/INR line and variance growth analysis ) should be included as they have been shown to be successful in improved prediction of bleeding and further thromboembolism .
CONCLUSIONS	The incidence of bleeding with dabigatran , for which there is no antidote , will require evaluation .

###25825410
BACKGROUND	Cardiac troponin and B-type natriuretic peptide ( BNP ) concentrations are associated with adverse cardiovascular outcome in primary prevention populations .
BACKGROUND	Whether statin therapy modifies this association is poorly understood .
RESULTS	We measured high-sensitivity cardiac troponin I ( hsTnI ) in 12956 and BNP in 11076 participants without cardiovascular disease in the Justification for the Use of Statins in Prevention : An Intervention Trial Evaluating Rosuvastatin ( JUPITER ) trial before randomization to rosuvastatin 20 mg/d or placebo .
RESULTS	Nearly 92 % of participants had detectable circulating hsTnI , and 2.9 % of men and 4.1 % of women had levels above proposed sex-specific reference limits of 36 and 15 ng/L , respectively .
RESULTS	hsTnI concentrations in the highest tertile were associated with a first major cardiovascular event ( adjusted hazard ratio [ aHR ] , 2.19 ; 95 % confidence interval , 1.56-3 .06 ; P for trend < 0.001 ) .
RESULTS	BNP levels in the highest tertile were also associated a first cardiovascular event ( aHR , 1.94 ; 95 % confidence interval , 1.41-2 .68 ; P for trend < 0.001 ) .
RESULTS	The risk of all-cause mortality was elevated for the highest versus the lowest tertiles of hsTnI ( aHR , 2.61 ; 95 % confidence interval , 1.81-3 .78 ; P for trend < 0.001 ) and BNP ( aHR , 1.45 ; 95 % confidence interval , 1.03-2 .04 ; P for trend 0.02 ) .
RESULTS	Rosuvastatin was equally effective in preventing a first cardiovascular event across categories of hsTnI ( aHR range , 0.50-0 .60 ) and BNP ( aHR range , 0.42-0 .67 ) with no statistically significant evidence of interaction ( P for interaction = 0.53 and 0.20 , respectively ) .
CONCLUSIONS	In a contemporary primary prevention population , baseline cardiac troponin I and BNP were associated with the risk of vascular events and all-cause mortality .
CONCLUSIONS	The benefits of rosuvastatin were substantial and consistent regardless of baseline hsTnI or BNP concentrations .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00239681 .

###24346676
OBJECTIVE	To test the efficacy of nutritional guidelines for school lunch cooks aiming to reduce added sugar in school meals and their own sugar intake .
METHODS	A controlled randomized cluster trial was carried out in twenty public schools in the municipality of Niteroi in Rio de Janeiro , Southeastern Brazil , from March to December 2007 .
METHODS	A nutrition educational program was implemented in the schools in question through messages , activities and printed educational materials encouraging reduced levels of added sugar in school meals and in the school lunch cooks ' own intake .
METHODS	The reduced availability of added sugar in schools was evaluated using spreadsheets including data on the monthly use of food item supplies .
METHODS	The cooks ' individual food intake was evaluated by a Food Frequency Questionnaire .
METHODS	Anthropometric measurements were taken according to standardized techniques and variation in weight was measured throughout the duration of the study .
RESULTS	There was a more marked reduction in the intervention schools compared to the control schools ( -6.0 kg versus 0.34 kg ) , but no statistically significant difference ( p = 0.21 ) , although the study power was low .
RESULTS	Both groups of school lunch cooks showed a reduction in the consumption of sweets and sweetened beverages , but the difference in sugar intake was not statistically significant .
RESULTS	Weight loss and a reduction in total energy consumption occurred in both groups , but the difference between them was not statistically significant , and there was no alteration in the percentages of adequacy of macronutrients in relation to energy consumption .
CONCLUSIONS	The strategy of reducing the use and consumption of sugar by school lunch cooks from public schools could not be proved to be effective .

###24312458
OBJECTIVE	To characterize via NMR spectroscopy the full spectrum of metabolic changes in umbilical vein blood plasma of newborns diagnosed with different clinical forms of intrauterine growth restriction ( IUGR ) .
METHODS	23 early IUGR cases and matched 23 adequate-for-gestational-age ( AGA ) controls and 56 late IUGR cases with 56 matched AGAs were included in this study .
METHODS	Early IUGR was defined as a birth weight < 10 ( th ) centile , abnormal umbilical artery ( UA ) Doppler and delivery < 35 weeks .
METHODS	Late IUGR was defined as a birth weight < 10 ( th ) centile with normal UA Doppler and delivery > 35 weeks .
METHODS	This group was subdivided in 18 vasodilated ( VD ) and 38 non-VD late IUGR fetuses .
METHODS	All AGA patients had a birth weight > 10 ( th ) centile .
METHODS	( 1 ) H nuclear magnetic resonance ( NMR ) metabolomics of the blood samples collected from the umbilical vein at delivery was obtained .
METHODS	Multivariate statistical analysis identified several metabolites that allowed the discrimination between the different IUGR subgroups , and their comparative levels were quantified from the NMR data .
RESULTS	The NMR-based analysis showed increased unsaturated lipids and VLDL levels in both early and late IUGR samples , decreased glucose and increased acetone levels in early IUGR .
RESULTS	Non-significant trends for decreased glucose and increased acetone levels were present in late IUGR , which followed a severity gradient when the VD and non-VD subgroups were considered .
RESULTS	Regarding amino acids and derivatives , early IUGR showed significantly increased glutamine and creatine levels , whereas the amounts of phenylalanine and tyrosine were decreased in early and late-VD IUGR samples .
RESULTS	Valine and leucine were decreased in late IUGR samples .
RESULTS	Choline levels were decreased in all clinical subforms of IUGR .
CONCLUSIONS	IUGR is not associated with a unique metabolic profile , but important changes are present in different clinical subsets used in research and clinical practice .
CONCLUSIONS	These results may help in characterizing comprehensively specific alterations underlying different IUGR subsets .

###25033901
OBJECTIVE	To compare intraocular lens implantation using a motorized injector vs standard manual injector through a 2.2-mm clear corneal incision .
METHODS	Patients underwent standard phacoemulsification using a 2.2-mm clear corneal incision .
METHODS	Hydrophobic acrylic aspheric intraocular lens ( Acrysof SN60WF intraocular lens ( IOL ) ) was inserted using D cartridge with manual monarch injector or autosert motorized injector .
METHODS	IOL safety , final incision size and wound integrity in terms of anterior and posterior wound gape , and descemet 's membrane detachment were compared between the two groups at post-operative day 1 and at 1 month using Anterior Segment Optical Coherence Tomography .
RESULTS	The study recruited 32 patients in the group I ( manual injector ) and 30 patients in group II ( motorized injector ) .
RESULTS	In group I , the final incision after IOL insertion increased by 0.12 mm ( 95 % CI : 0.134-0 .106 ) ( P < 0.0001 ) , which was seen in 100 % of the patients .
RESULTS	In group II , the incision enlarged by 0.01 ( 95 % CI : 0.021-0 .0.001 ) ( P = 0.07 ) and was seen in only 6.67 % of the cases .
RESULTS	IOL nicks were seen in 9.37 % of the cases in group I only .
RESULTS	Although the incidence of descemet 's membrane detachment and anterior wound gape was similar for both groups , posterior wound gape was seen more often with the manual injector in the immediate post-operative period .
RESULTS	( P = 0.018 ) CONCLUSION : The motorized insertion system was gentle and safe for the IOLs with lesser incidence of IOL nicks .
RESULTS	Regarding wound safety , it caused significantly less incision enlargement and better posterior wound integrity .

###24228528
OBJECTIVE	To discuss the drug intervention in diversity changes of TCRVbeta gene in AIDS patients with incomplete immune reconstitution .
METHODS	PBMCs were isolated from 37 cases of AIDS patients failure to immune reconstitution before and after treatment with immune 2 and 15 cases of HIV negative healthy donors .
METHODS	The human gene TCRVbeta CDR3 diversity quantitative detection reagent box were used , and mapped the distribution of gene scanning and calculated different CDR3 fragme of each Vbeta family size .
RESULTS	Compared with the normal group , there appeared some single or oligoclonal amplification of Vbeta CDR3 region in the patients , which were improved or recovered after treatment .
RESULTS	Among them , D value of four families ( 9 , 11 , 21 , 22 ) decreased after treatment in both groups .
RESULTS	The decrease in family 21 and 22 was significant ( P < 0.05 ) in treatment group compared with the control group .
RESULTS	And family 18 was decreased in treatment group and increased significantly in control group ( P < 0.05 ) .
CONCLUSIONS	Study of the mechanism showed oligoclonal of TCRVbeta family can get recovery in some degrees after treated by Immune 2 plus HAART , suggesting that the medicine may promote T-cell receptor gene rearrangement , helping immune cells to effectively identify the virus to reduce T-cell apoptosis .

###25224756
BACKGROUND	Mother-to-child transmission of HIV remains an important public health problem in sub-Saharan Africa .
BACKGROUND	As HIV testing and linkage to PMTCT occurs in antenatal care ( ANC ) , major challenges for any PMTCT option in developing countries , including Tanzania , are delays in the first ANC visit and a low overall number of visits .
BACKGROUND	Community health workers ( CHWs ) have been effective in various settings in increasing the uptake of clinical services and improving treatment retention and adherence .
BACKGROUND	At the beginning of this trial in January 2013 , the World Health Organization recommended either of two medication regimens , Option A or B , for prevention of mother-to-child transmission of HIV ( PMTCT ) .
BACKGROUND	It is still largely unclear which option is more effective when implemented in a public healthcare system .
BACKGROUND	This study aims to determine the effectiveness , cost-effectiveness , acceptability , and feasibility of : ( 1 ) a community health worker ( CWH ) intervention and ( 2 ) PMTCT Option B in improving ANC and PMTCT outcomes .
METHODS	This study is a cluster-randomized controlled health systems implementation trial with a two-by-two factorial design .
METHODS	All 60 administrative wards in the Kinondoni and Ilala districts in Dar es Salaam were first randomly allocated to either receiving the CHW intervention or not , and then to receiving either Option B or A. Under the standard of care , facility-based health workers follow up on patients who have missed scheduled appointments for PMTCT , first through a telephone call and then with a home visit .
METHODS	In the wards receiving the CHW intervention , the CHWs : ( 1 ) identify pregnant women through home visits and refer them to antenatal care ; ( 2 ) provide education to pregnant women on antenatal care , PMTCT , birth , and postnatal care ; ( 3 ) routinely follow up on all pregnant women to ascertain whether they have attended ANC ; and ( 4 ) follow up on women who have missed ANC or PMTCT appointments .
BACKGROUND	ClinicalTrials.gov : EJF22802 .
BACKGROUND	Registration date : 14 May 2013 .

###24899321
BACKGROUND	Spinal anesthesia is widely used for caesarean section due to its rapid onset , low failure rate , complete analgesia .
BACKGROUND	Addition of intrathecal ketamine and opioids to local anaesthetics seems to improve the quality of block and prolong the duration of analgesia .
OBJECTIVE	The purpose of this study was to compare the effect of intrathecal ketamine mixed with hyperbaric bupivacaine to intrathecal fentanyl mixed with hyperbaric bupivacaine .
METHODS	One hundred parturients ASA Grade I scheduled for elective or semiurgent caesarean section under spinal anaesthesia were randomly divided into two groups .
METHODS	Group A received 2ml ( 10 mg ) hyperbaric bupivacaine 0.5 % plus 25 mg preservative free ketamine .
METHODS	Group B received 2ml ( 10mg ) hyperbaric bupivacaine 0.5 % plus 25g fentanyl .
METHODS	The patients were observed intraoperatively for the onset of sensory block , degree of motor block and total duration of analgesia .
RESULTS	The time to achieve Bromage scale 3 motor blockade was shorter in Group A than in Group B. ( p = 0.445 ) whereas time to achieve highest dermatomal level of sensory block was shorter in Group A than in Group B ( p = 0.143 ) .
RESULTS	The duration of spinal analgesia was longer in Group B than in Group A ( p = 0.730 ) .
RESULTS	The frequency of side effect such as sedation score was higher in Group A compared to Group B ( p = 0.048 ) .
RESULTS	The incidence of pruritus was significantly higher in Group B compared to Group A ( p = 0.000 ) .
CONCLUSIONS	Addition of preservative free ketamine lead to faster onset of sensory and motor blockade , although it did not prolong the duration of spinal analgesia compared to addition of fentanyl in parturients undergoing caesarean section with spinal anaesthesia .

###24658148
OBJECTIVE	This study aims to determine the outcome of double-bundle anterior cruciate ligament ( ACL ) reconstruction using an allograft in comparison with ACL reconstruction using a double-bundle autograft or a single-bundle allograft .
METHODS	A total of 424 patients who accepted primary ACL reconstructions were divided randomly into three groups : double-bundle technique with autograft ( DB-AU group , n = 154 ) , double-bundle technique with allograft ( DB-AL group , n = 128 ) , and single-bundle technique with allograft ( SB group , n = 142 ) .
METHODS	The KT-1000 arthrometer and pivot-shift tests were performed at 3 , 12 , and 36 months after surgery , and clinical outcome measurements include the Lysholm score and the IKDC rating scales .
METHODS	Radiological assessments evaluated arthritic changes and tunnel expansion at 36 months postoperatively .
RESULTS	The KT-1000 test scores in the DB-AU and DB-AL groups were significantly better than those in the SB group at 12 and 36 months postoperatively ( P < 0.05 ) .
RESULTS	The pivot-shift tests scores in the DB-AU and DB-AL groups were significantly better than those in the SB group at the 3 , 12 , and 36 month follow-ups ( P < 0.05 ) .
RESULTS	Based on the IKDC score and Lysholm score , there were no significant difference between the three groups during follow-up ( P > 0.05 ) .
RESULTS	At 36 months postoperatively , 42.3 % of patients in the SB group showed a progression in arthritic changes , which was greater than in the DB-AU ( 29.2 % ) and DB-AL ( 27.3 % ) groups ( P < 0.05 ) .
RESULTS	At 36 months , the rates of tunnel expansion in the DB-AU group and the DB-AL group were lower than in the SB group ( P < 0.05 ) .
CONCLUSIONS	Double-bundle ACL reconstruction can be used to achieve better anterior and rotational stability and has a lower rate of arthritic progression and tunnel expansion than the single-bundle procedure .
METHODS	I.

###24970468
BACKGROUND	Fixed-dose combination of isosorbide dinitrate and hydralazine ( FDC-I/H ) reduced mortality by 43 % and death or first hospitalization for heart failure ( HF ) by 37 % in the African-American Heart Failure Trial ( A-HeFT ) .
BACKGROUND	Reduction in mortality makes it difficult to determine the effect on hospitalizations unless the analysis adjusts for death as a competing risk .
RESULTS	In A-HeFT , 1050 self-identified black patients with moderate to severe HF were randomized to FDC-I/H or placebo .
RESULTS	The effects of FDC-I/H on first and all hospitalizations and 30-day readmission rates were analyzed .
RESULTS	Deaths as competing risks were adjusted using Fine-Gray regression and joint models of hospitalizations and mortality .
RESULTS	There were 558 all-cause and 251 HF hospitalizations in placebo compared with 435 and 173 hospitalizations in the FDC-I/H group .
RESULTS	Adjusting for deaths as a competing risk , the effect of FDC-I/H on the first hospitalization for HF , expressed in hazard ratio ( 95 % confidence interval ) , was 0.61 ( 0.47-0 .80 ; P < 0.001 ) and 0.88 ( 0.72-1 .06 ; P = 0.18 ) on the first all-cause hospitalization .
RESULTS	The effect of FDC-I/H on all recurrent hospitalizations for HF was 0.66 ( 0.52-0 .83 ; P = 0.0005 ) , similar to the effect on the first hospitalizations for HF , whereas the effect on all hospitalizations for any cause was 0.75 ( 0.63-0 .91 ; P = 0.003 ) .
RESULTS	The 30-day all-cause readmission rate after the first hospitalization for HF was 23.6 % ( 29 of 123 ) in placebo versus 14.8 % ( 12 of 81 ) in the FDC-I/H group , but the effect ( 0.59 ; 0.30-1 .16 ; P = 0.12 ) in this small subgroup was not significant .
CONCLUSIONS	Treatment with FDC-I/H was associated with a substantial reduction in the first and recurrent HF hospitalizations , and in total all-cause hospitalizations , reducing the total burden of costly and distressing hospitalizations .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00047775 .

###24532394
BACKGROUND	Hemodialysis patients are at risk of serious health complications , yet treatment non-adherence remains high .
OBJECTIVE	Warnings about health risks associated with non-adherence may trigger defensive reactions .
OBJECTIVE	We studied whether an intervention based on self-affirmation theory ( Steele 1988 ) reduced patients ' resistance to health-risk information and improved adherence .
METHODS	One hundred twelve patients either self-affirmed or completed a matched control task before reading about the risks associated with a lack of phosphate control .
METHODS	Serum phosphate was collected from baseline up to 12months .
RESULTS	Self-affirmed patients had significantly reduced serum phosphate levels at 1 and 12months .
RESULTS	However , contrary to the predictions derived from self-affirmation theory , self-affirmed participants and controls did not differ in their evaluation of the health-risk information , behavioural intention or self-efficacy .
CONCLUSIONS	A low-cost , high-reach health intervention based on self-affirmation theory was shown to reduce serum phosphate over a 12month period .
CONCLUSIONS	Further work is required to identify mediators of the observed effects .

###24903467
BACKGROUND	Bardoxolone methyl , an Nrf2-activating and nuclear factor-B-inhibiting semisynthetic oleanane triterpenoid compound , was evaluated in a phase 3 trial ( BEACON ) in patients with type 2 diabetes mellitus ( T2DM ) and stage 4 chronic kidney disease ( CKD ) .
BACKGROUND	The trial was terminated because of an increase in heart failure events in the bardoxolone methyl group , many of which appeared related to fluid retention .
BACKGROUND	Thus , additional analyses were conducted to explain these serious adverse events .
METHODS	Patients ( n = 2,185 ) were randomized to receive once-daily bardoxolone methyl ( 20 mg ) or placebo .
METHODS	Twenty-four-hour urine collections were analyzed in a subset of the BEACON population and from a separate , open-label pharmacology study in patients with stage 3b/4 CKD and T2DM administered 20 mg bardoxolone methyl once daily for 56 consecutive days .
RESULTS	Bardoxolone-methyl-treated patients in the BEACON substudy had a clinically meaningful reduction in urine volume and sodium excretion at week 4 relative to baseline ( p < 0.05 ) , and a separate study revealed that decreased sodium excretion and urine output occurred in some patients with stage 4 CKD but not those with stage 3b CKD .
RESULTS	The clinical phenotype of fluid overload and heart failure in BEACON was similar to that observed with endothelin receptor antagonists in advanced CKD patients , and preclinical data demonstrate that bardoxolone methyl modifies endothelin signaling .
CONCLUSIONS	The totality of the evidence suggests that through modulation of the endothelin pathway , bardoxolone methyl may pharmacologically promote acute sodium and volume retention and increase blood pressure in patients with more advanced CKD .

###25216649
BACKGROUND	Continuous theta burst stimulation ( cTBS ) of the human primary motor cortex ( M1 ) induces long-term depression ( LTD ) - like plastic changes in corticospinal excitability , but several studies have reported high inter-subject variability of this effect .
BACKGROUND	Most studies use a tonic voluntary contraction of the target muscle before cTBS to set stimulation intensity ; however , it is unclear how this might affect response variability .
OBJECTIVE	To examine the influence of pre-activation of the target hand muscle on inter-subject response variability to cTBS of the human M1 .
METHODS	The response to cTBS was assessed by changes in motor evoked potential ( MEP ) amplitude in the right first dorsal interosseous ( FDI ) muscle .
METHODS	For Study 1 , ten healthy subjects attended two sessions .
METHODS	They were instructed in one session to keep their FDI relaxed for the entire testing period ( pre-relax ) , and in the other to perform a 2-min 10 % of maximal voluntary tonic contraction 15 min before cTBS ( pre-active ) .
METHODS	For Study 2 , data from our previous study were re-analyzed to extend the pre-relax condition to an additional 26 subjects ( total n = 36 ) .
RESULTS	cTBS-induced highly consistent LTD-like MEP depression in the pre-relax condition , but not in the pre-active condition .
RESULTS	Inter-subject response variability increased in the pre-active condition .
CONCLUSIONS	cTBS induces consistent LTD-like plasticity with low inter-subject variability if pre-activation of the stimulated motor cortex is avoided .
CONCLUSIONS	This affirms a translational potential of cTBS in clinical applications that aim at reducing cortical excitability .

###24944062
BACKGROUND	Current thinking , which is based mainly on rodent studies , is that physiologic doses of folic acid ( pterylmonoglutamic acid ) , such as dietary vitamin folates , are biotransformed in the intestinal mucosa and transferred to the portal vein as the natural circulating plasma folate , 5-methyltetrahydrofolic acid ( 5-MTHF ) before entering the liver and the wider systemic blood supply .
OBJECTIVE	We tested the assumption that , in humans , folic acid is biotransformed ( reduced and methylated ) to 5-MTHF in the intestinal mucosa .
METHODS	We conducted a crossover study in which we sampled portal and peripheral veins for labeled folate concentrations after oral ingestion with physiologic doses of stable-isotope-labeled folic acid or the reduced folate 5-formyltetrahydrofolic acid ( 5-FormylTHF ) in 6 subjects with a transjugular intrahepatic porto systemic shunt ( TIPSS ) in situ .
METHODS	The TIPSS allowed blood samples to be taken from the portal vein .
RESULTS	Fifteen minutes after a dose of folic acid , 80 12 % of labeled folate in the hepatic portal vein was unmodified folic acid .
RESULTS	In contrast , after a dose of labeled 5-FormylTHF , only 4 18 % of labeled folate in the portal vein was unmodified 5-FormylTHF , and the rest had been converted to 5-MTHF after 15 min ( postdose ) .
CONCLUSIONS	The human gut appears to have a very efficient capacity to convert reduced dietary folates to 5-MTHF but limited ability to reduce folic acid .
CONCLUSIONS	Therefore , large amounts of unmodified folic acid in the portal vein are probably attributable to an extremely limited mucosal cell dihydrofolate reductase ( DHFR ) capacity that is necessary to produce tetrahydrofolic acid before sequential methylation to 5-MTHF .
CONCLUSIONS	This process would suggest that humans are reliant on the liver for folic acid reduction even though it has a low and highly variable DHFR activity .
CONCLUSIONS	Therefore , chronic liver exposure to folic acid in humans may induce saturation , which would possibly explain reports of systemic circulation of unmetabolized folic acid .

###24393146
BACKGROUND	Ankle sprains continue to pose a significant burden to the individual athlete , as well as to society as a whole .
BACKGROUND	However , despite ankle sprains being the single most common sports injury and despite an active approach by various Dutch organisations in implementing preventive measures , large-scale community uptake of these preventive measures , and thus actual prevention of ankle sprains , is lagging well behind .
BACKGROUND	In an attempt to bridge this implementation gap , the Dutch Consumer Safety Institute VeiligheidNL developed a freely available interactive App ( ` Strenghten your ankle ' translated in Dutch as : ` Versterk je enkel ; available for iOS and Android ) that contains - next to general advice on bracing and taping - a proven cost-effective neuromuscular program .
BACKGROUND	The ` Strengthen your ankle ' App has not been evaluated against the ` regular ' prevention approach in which the neuromuscular program is advocated through written material .
BACKGROUND	The aim of the current project is to evaluate the implementation value of the ` Strengthen your ankle ' App as compared to the usual practice of providing injured athletes with written materials .
BACKGROUND	In addition , as a secondary outcome measure , the cost-effectiveness will be assessed against usual practice .
METHODS	The proposed study will be a randomised controlled trial .
METHODS	After stratification for medical caregiver , athletes will be randomised to two study groups .
METHODS	One group will receive a standardized eight-week proprioceptive training program that has proven to be cost-effective to prevent recurrent ankle injuries , consisting of a balance board ( machU / MSG Europe BVBA ) , and a traditional instructional booklet .
METHODS	The other group will receive the same exercise program and balance board .
METHODS	However , for this group the instructional booklet is exchanged by the interactive ` Strengthen your ankle ' App .
CONCLUSIONS	This trial is the first randomized controlled trial to study the implementation effectiveness of an App for proprioceptive balance board training program in comparison to a traditional printed instruction booklet , with the recurrence of ankle sprains among athletes as study outcome .
CONCLUSIONS	Results of this study could possibly lead to changes in practical guidelines on the treatment of ankle sprains and in the use of mobile applications for injury prevention .
CONCLUSIONS	Results will become available in 2014 .
BACKGROUND	The Netherlands National Trial Register NTR4027 .
BACKGROUND	The NTR is part of the WHO Primary Registries .

###24831037
OBJECTIVE	Topical glaucoma medications lower intraocular pressure and alter the course of the disease .
OBJECTIVE	Because adherence with glaucoma medications is a known problem , interventions are needed to help those patients who do not take their medications as prescribed .
OBJECTIVE	To assess the ability of an automated telecommunication-based intervention to improve adherence with glaucoma medications .
METHODS	We performed a prospective cohort study of medication adherence , followed by a randomized intervention for those found to be nonadherent , of individuals recruited from a university-based glaucoma subspecialty clinic .
METHODS	A total of 491 participants were enrolled in the initial assessment of adherence .
METHODS	Of those , 70 were nonadherent with their medications after 3 months of electronic monitoring and randomized to intervention and control groups .
METHODS	A personal health record was used to store the list of patient medications and reminder preferences .
METHODS	On the basis of those data , participants randomized to the intervention received daily messages , either text or voice , reminding them to take their medication .
METHODS	Participants randomized to the control group received usual care .
METHODS	Difference in adherence before and after initiation of the intervention .
RESULTS	Using an intent-to-treat analysis , we found that the median adherence rate in the 38 participants randomized to the intervention increased from 53 % to 64 % ( P < .05 ) .
RESULTS	There was no statistical change in 32 participants in the control group .
RESULTS	To assess the real efficacy of the intervention , the same comparison was performed for the participants who successfully completed the study after randomization .
RESULTS	Analyzed this way , the adherence rate in the 20 participants in the intervention group increased from 54 % to 73 % ( P < .05 ) , whereas there was again no statistical change in the 19 participants in the control group .
RESULTS	Eighty-four percent of the participants who received reminders agreed they were helpful and would continue using them outside the study .
CONCLUSIONS	Automated telecommunication-based reminders linked to data in a personal health record improved adherence with once-daily glaucoma medications .
CONCLUSIONS	This is an effective method to improve adherence that could realistically be implemented in ophthalmology practices with a minimum amount of effort on the part of the practice or the patient .

###25489785
BACKGROUND	Rifapentine has potent activity in mouse models of tuberculosis chemotherapy but its optimal dose and exposure in humans are unknown .
OBJECTIVE	We conducted a randomized , partially blinded dose-ranging study to determine tolerability , safety , and antimicrobial activity of daily rifapentine for pulmonary tuberculosis treatment .
METHODS	Adults with sputum smear-positive pulmonary tuberculosis were assigned rifapentine 10 , 15 , or 20 mg/kg or rifampin 10 mg/kg daily for 8 weeks ( intensive phase ) , with isoniazid , pyrazinamide , and ethambutol .
METHODS	The primary tolerability end point was treatment discontinuation .
METHODS	The primary efficacy end point was negative sputum cultures at completion of intensive phase .
RESULTS	A total of 334 participants were enrolled .
RESULTS	At completion of intensive phase , cultures on solid media were negative in 81.3 % of participants in the rifampin group versus 92.5 % ( P = 0.097 ) , 89.4 % ( P = 0.29 ) , and 94.7 % ( P = 0.049 ) in the rifapentine 10 , 15 , and 20 mg/kg groups .
RESULTS	Liquid cultures were negative in 56.3 % ( rifampin group ) versus 74.6 % ( P = 0.042 ) , 69.7 % ( P = 0.16 ) , and 82.5 % ( P = 0.004 ) , respectively .
RESULTS	Compared with the rifampin group , the proportion negative at the end of intensive phase was higher among rifapentine recipients who had high rifapentine areas under the concentration-time curve .
RESULTS	Percentages of participants discontinuing assigned treatment for reasons other than microbiologic ineligibility were similar across groups ( rifampin , 8.2 % ; rifapentine 10 , 15 , or 20 mg/kg , 3.4 , 2.5 , and 7.4 % , respectively ) .
CONCLUSIONS	Daily rifapentine was well-tolerated and safe .
CONCLUSIONS	High rifapentine exposures were associated with high levels of sputum sterilization at completion of intensive phase .
CONCLUSIONS	Further studies are warranted to determine if regimens that deliver high rifapentine exposures can shorten treatment duration to less than 6 months .
CONCLUSIONS	Clinical trial registered with www.clinicaltrials.gov ( NCT 00694629 ) .

###24902075
BACKGROUND	Rhomboid excision with Limberg flap repair ( RELIF ) is an effective surgical procedure in pilonidal sinus disease ( PSD ) treatment .
BACKGROUND	This study aimed to compare outcome of diathermy and scalpel in RELIF procedure in PSD surgery .
METHODS	Patients undergoing RELIF procedure due to PSD at Adana Numune Training and Research Hospital between January 2012 and September 2012 were randomly assigned to diathermy ( n = 30 ) or scalpel ( n = 30 ) groups .
METHODS	The primary outcomes measured were duration of operation , drainage volume , postoperative numerical pain intensity scale ( NPIS ) scores , complications , duration of hospitalization length and time to return to daily activity .
RESULTS	The mean age was 26.2 years ( 17-44 years ) .
RESULTS	The mean operation duration was significantly lower in diathermy group ( p = 0.0001 ) .
RESULTS	Postoperative total NPIS score within the first 24 h was significantly lower in diathermy group ( p = 0.001 ) .
RESULTS	However , there were not any significant differences in term of NPIS scores in day 3 and day 7 .
RESULTS	There were no significant differences in terms of total drain output , drain removal time and length of hospital stay .
RESULTS	There were no significant differences between groups in terms of duration to sit comfortably , return to daily activity and work .
RESULTS	Recurrence of PSD was emerged in one patient in the diathermy group .
CONCLUSIONS	Diathermy dissection in RELIF procedure in pilonidal sinus surgery is a safe technique and decreased operation time and postoperative pain .

###24879581
OBJECTIVE	A self-control study was designed to compare the process of creeping substitution between allograft bone and local bone grafting in lumbar interbody fusion .
METHODS	From December 2011 to July 2012 , 81 patients ( mean age : 56.4 ) were included in this study and randomly allocated to two groups .
METHODS	Leopard cages were using in unilateral instrumentation transforaminal lumbar interbody fusion .
METHODS	In group 1 , the cages were filled with the local bone on the side of the instrumentation and allograft bone on the other side .
METHODS	In group 2 , they were totally filled with the local bone chips .
METHODS	Then , the special CT-reconstructions were made at 6 - and 12-month follow-up .
METHODS	On the sagittal section , the sections of CT-reconstructions were perpendicular to the lateral axis of the cage from the side of the cage to the other side .
METHODS	Similarly , they were parallel to the lateral axis of the cage on the coronal section and intervertebral space on the cross section .
METHODS	The mean area size of bone mass on both sides of the cage was calculated , respectively , using image analysis software ( Osirix , version 3.3.2 ) on each section in two groups .
RESULTS	In group 1 , at 6 - and 12-month follow-up , significant differences were observed in the mean area size of bone mass between allograft bone and local bone grafting on the coronal , cross , and sagittal section .
RESULTS	In group 2 , the mean area size of local bone on both sides of the cage had no significant differences at 6 - and 12-month follow-up on each section .
CONCLUSIONS	The results of our study showed a superiority of local bone grafting over allograft bone .

###25607709
OBJECTIVE	To evaluate the efficacy of sequential therapy of cryotherapy and sinecatechins 15 % ointment BID versus cryotherapy alone in treatment of external genital warts ( EGW ) .
METHODS	Forty-two subjects with at least two EGW lesions underwent cryotherapy to all lesions .
METHODS	One week following cryotherapy , subjects were randomized 1:1 to receive either no additional treatment or treatment with sinecatechins 15 % ointment BID up to 16 weeks or until complete clearance .
METHODS	The total number of visible baseline and new EGW were recorded at each visit .
METHODS	Subjects were followed for a total of 65 weeks post-treatment .
RESULTS	There was a significant reduction in mean number of lesions from baseline after 16 weeks of treatment in the cryotherapy-sinecatechins ointment group compared to cryotherapy alone ( -5.0 lesions vs -2.1 lesions respectively , P = 0.07 ) .
CONCLUSIONS	Cryotherapy plus sinecatechins 15 % ointment BID resulted in a significant improvement in the reduction of EGW compared to cryotherapy alone .
CONCLUSIONS	Clinicaltrials.gov registration identifier : NCT02147353 .

###25897676
BACKGROUND	The MEK inhibitor , selumetinib , suppresses soft-tissue sarcoma ( STS ) cell proliferation in vitro .
BACKGROUND	Mammalian target of rapamycin inhibitors possess modest activity against STS ; however , resistance develops via MAPK pathway feedback activation .
BACKGROUND	The combination of selumetinib and temsirolimus synergistically inhibits STS cell line growth .
BACKGROUND	Therefore , a randomized phase II trial of selumetinib vs selumetinib plus temsirolimus was conducted .
METHODS	Seventy-one adults with advanced STS who received 2 prior chemotherapeutics were randomized to selumetinib 75 mg p.o. bid and allowed to crossover upon progression , or to selumetinib 50 mg p.o. bid plus temsirolimus 20 mg i.v. weekly , with primary endpoint of progression-free survival ( PFS ) .
RESULTS	There was no difference in PFS between the two arms for the overall cohort ( median 1.9 vs 2.1 months ) ; an improved median PFS was observed in the combination arm ( N = 11 ) over single agent ( N = 10 ) in the prespecified leiomyosarcoma stratum ( median 3.7 vs 1.8 months ; P = 0.01 ) .
RESULTS	Four-month PFS rate was 50 % ( 95 % confidence interval 0.19-0 .81 ) with the combination vs 0 % with selumetinib alone in the leiomyosarcoma cohort .
RESULTS	Most common grade 3/4 adverse events with the combination were mucositis ( 29 % ) , lymphopenia ( 26 % ) , neutropenia and anaemia ( 20 % each ) .
CONCLUSIONS	While single-agent selumetinib has no significant activity in STS , the combination may be active for leiomyosarcomas .

###24742300
BACKGROUND	More than seven out of 10 Dutch construction workers describe their work as physically demanding .
BACKGROUND	Ergonomic measures can be used to reduce these physically demanding work tasks .
BACKGROUND	To increase the use of ergonomic measures , employers and workers have to get used to other working methods and to maintaining them .
BACKGROUND	To facilitate this behavioural change , participatory ergonomics ( PE ) interventions could be useful .
BACKGROUND	For this study a protocol of a PE intervention is adapted in such a way that the intervention can be performed by an ergonomics consultant through face-to-face contacts or email contacts .
BACKGROUND	The objective of this study is to evaluate the effectiveness of the face-to-face guidance strategy and the e-guidance strategy on the primary outcome measure : use of ergonomic measures by individual construction workers , and on the secondary outcome measures : the work ability , physical functioning and limitations due to physical problems of individual workers .
METHODS	The present study is a randomised intervention trial of six months in 12 companies to establish the effects of a PE intervention guided by four face-to-face contacts ( N = 6 ) or guided by 13 email contacts ( N = 6 ) on the primary and secondary outcome measures at baseline and after six months .
METHODS	Construction companies are randomly assigned to one of the guidance strategies with the help of a computer generated randomisation table .
METHODS	In addition , a process evaluation for both strategies will be performed to determine reach , dose delivered , dose received , precision , competence , satisfaction and behavioural change to find possible barriers and facilitators for both strategies .
METHODS	A cost-benefit analysis will be performed to establish the financial consequences of both strategies .
METHODS	The present study is in accordance with the CONSORT statement .
CONCLUSIONS	The outcome of this study will help to 1 ) evaluate the effect of both guidance strategies , and 2 ) find barriers to and facilitators of both guidance strategies .
CONCLUSIONS	When these strategies are effective , implementation within occupational health services can take place to guide construction companies ( and others ) with the implementation of ergonomic measures .
BACKGROUND	[ corrected ] Trailnumber : ISRCTN73075751 , Date of registration : 30 July 2013 .

###24644301
BACKGROUND	The reported prevalence of radiological osteoarthritis ( OA ) after anterior cruciate ligament ( ACL ) reconstruction varies from 10 % to 90 % .
BACKGROUND	Purpose /
OBJECTIVE	To report the prevalence of OA after ACL reconstruction and to compare the OA prevalence between quadrupled semitendinosus tendon ( ST ) and bone-patellar tendon-bone ( BPTB ) grafts .
OBJECTIVE	The hypothesis was that there would be no difference in OA prevalence between the graft types .
OBJECTIVE	The secondary aim was to study whether patient characteristics and additional injuries were associated with long-term outcomes .
METHODS	Randomized controlled trial ; Level of evidence , 1 .
METHODS	Radiological examination results , Tegner activity levels , and Knee injury and Osteoarthritis Outcome Score ( KOOS ) values were determined in 135 ( 82 % ) of 164 patients at a mean of 14 years after ACL reconstruction randomized to an ST or a BPTB graft .
METHODS	Osteoarthritis was defined according to a consensus by at least 2 of 3 radiologists of Kellgren-Lawrence grade 2 .
METHODS	Using regression analysis , graft type , sex , age , overweight , time between injury and reconstruction , additional meniscus injury , and a number of other variables were assessed as risk factors for OA 14 years after ACL reconstruction .
RESULTS	Osteoarthritis of the medial compartment was most frequent , with 57 % of OA cases in the ACL-reconstructed knee and 18 % of OA cases in the contralateral knee ( P < .001 ) .
RESULTS	There was no difference between the graft types : 49 % of OA of the medial compartment for BPTB grafts and 65 % for ST grafts ( P = .073 ) .
RESULTS	The KOOS results were lower for patients with OA in all subscales , indicating that OA was symptomatic .
RESULTS	No difference in the KOOS between the graft types was found .
RESULTS	Meniscus resection was a strong risk factor for OA of the medial compartment ( odds ratio , 3.6 ; 95 % CI , 1.4-9 .3 ) in the multivariable logistic regression analysis .
CONCLUSIONS	A 3-fold increased prevalence of OA was found after an ACL injury treated with reconstruction compared with the contralateral healthy knee .
CONCLUSIONS	No differences in the prevalence of OA between the BPTB and quadrupled ST reconstructions were found .
CONCLUSIONS	An initial meniscus resection was a strong risk factor for OA ; the time between injury and reconstruction was not .

###24343275
BACKGROUND	Microencapsulated sodium butyrate ( MSB ) has been previously associated with anti-inflammatory and regenerative properties regarding large bowel mucosa .
BACKGROUND	We aimed to examine a role of MSB in patients with diverticulosis , hypothesizing its potential for reduction of diverticulitis episodes and diverticulitis prevention .
METHODS	Seventy-three patients with diverticulosis ( diagnosed in colonoscopy or/and barium enema or/and CT colography ) were recruited for the study and randomized .
METHODS	The investigated group was administered MSB 300 mg daily ; the control group was administered placebo .
METHODS	After 12 months , a total of 52 patients completed the study and were subject to analysis ( 30 subjects and 22 controls ) .
METHODS	During the study , the number of episodes of diverticulitis ( symptomatic diagnosis with acute pain , fever , and leukocytosis ) , hospitalizations , and surgery performed for diverticulitis were recorded .
METHODS	Additionally , a question regarding subjective improvement of symptoms reflected changes in quality of life during the analysis .
RESULTS	After 12 months , the study group noted a significantly decreased number of diverticulitis episodes in comparison to the control group .
RESULTS	The subjective quality of life in the study group was higher than in the control group .
RESULTS	There were no side effects of the MSB during the therapy .
CONCLUSIONS	MSB reduces the frequency of diverticulitis episodes , is safe , and improves the quality of life .
CONCLUSIONS	It can play a role in the prevention of diverticulitis .

###25788231
BACKGROUND	Based on the early results of the Placement of Aortic Transcatheter Valves ( PARTNER ) trial , transcatheter aortic valve replacement ( TAVR ) is an accepted treatment for patients with severe aortic stenosis who are not suitable for surgery .
BACKGROUND	However , little information is available about the late clinical outcomes in such patients .
METHODS	We did this randomised controlled trial at 21 experienced valve centres in Canada , Germany , and the USA .
METHODS	We enrolled patients with severe symptomatic inoperable aortic stenosis and randomly assigned ( 1:1 ) them to transfemoral TAVR or to standard treatment , which often included balloon aortic valvuloplasty .
METHODS	Patients and their treating physicians were not masked to treatment allocation .
METHODS	The randomisation was done centrally , and sites learned of the assignment only after a patient had been screened , consented , and entered into the database .
METHODS	The primary outcome of the trial was all-cause mortality at 1 year in the intention-to-treat population , here we present the prespecified findings after 5 years .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00530894 .
RESULTS	We screened 3015 patients , of whom 358 were enrolled ( mean age 83 years , Society of Thoracic Surgeons Predicted Risk of Mortality 117 % , 54 % female ) .
RESULTS	179 were assigned to TAVR treatment and 179 were assigned to standard treatment .
RESULTS	20 patients crossed over from the standard treatment group and ten withdrew from study , leaving only six patients at 5 years , of whom five had aortic valve replacement treatment outside of the study .
RESULTS	The risk of all-cause mortality at 5 years was 718 % in the TAVR group versus 936 % in the standard treatment group ( hazard ratio 050 , 95 % CI 039-065 ; p < 00001 ) .
RESULTS	At 5 years , 42 ( 86 % ) of 49 survivors in the TAVR group had New York Heart Association class 1 or 2 symptoms compared with three ( 60 % ) of five in the standard treatment group .
RESULTS	Echocardiography after TAVR showed durable haemodynamic benefit ( aortic valve area 152 cm ( 2 ) at 5 years , mean gradient 106 mm Hg at 5 years ) , with no evidence of structural valve deterioration .
CONCLUSIONS	TAVR is more beneficial than standard treatment for treatment of inoperable aortic stenosis .
CONCLUSIONS	TAVR should be strongly considered for patients who are not surgical candidates for aortic valve replacement to improve their survival and functional status .
CONCLUSIONS	Appropriate selection of patients will help to maximise the benefit of TAVR and reduce mortality from severe comorbidities .
BACKGROUND	Edwards Lifesciences .

###24397194
OBJECTIVE	Hepatitis C virus ( HCV ) infection is an important sociomedical problem worldwide because the chronification of the disease is frequent and the occurance of liver cirrhosis and hepatocellular carcinoma can be expected .
OBJECTIVE	The aim of this study was to determine the way of infection , pathohistological changes of the liver , virus genotype presence and sustained virological response after pegylated interferon and ribavirin therapy in prison inmates .
METHODS	The study included 52 patients with chronic HCV infection classified in two groups managed during 2008-2010 .
METHODS	The first group consisted of prisoners ( n = 22 ) and the second one of `` non-prisoners '' ( n = 30 ) .
METHODS	The patients from both groups underwent diagnostic preparation ( biochemical analyses , liver biopsy , hepatitis virus detection and genotypisation using polymerase chain reaction issue ) .
METHODS	The treatment lasted for 24 weeks for virus genotypes 2 and 3 , and 48 weeks for genotypes 1 and 4 .
RESULTS	All the patients were males , approximately the same age ( 35 + / - 4.1 and 31 + / - 7.6 years ) .
RESULTS	Virus genotype 1 was significantly more frequent in the prisoners ( p < 0.05 ) , that demanded longer treatment ( 48 weeks ) .
RESULTS	At the same time , statistically significant higher number of patients , `` non-prisoners '' , achieved a sustained virological response ( p < 0.01 ) .
CONCLUSIONS	Intravenous drug abuse and tattoos , separately or together , are the most frequent way of infection in prisoners .
CONCLUSIONS	The dominant presence of virus genotype 1 resulted in lower number of patients with sustained virological response , probably regardless prison environment and regime .

###24487732
BACKGROUND	During spinal surgery , intraoperative monitoring of motor-evoked potentials ( MEPs ) is a useful means of assessing the intraoperative integrity of corticospinal pathways .
BACKGROUND	However , MEPs are known to be particularly sensitive to the suppressive effects of inhalational halogenated anesthetic agents .
OBJECTIVE	To investigate the effects of increasing end-tidal concentrations of desflurane and sevoflurane anesthesia in a background of propofol and remifentanil with multipulse cortical stimulation on intraoperative monitoring of MEPs .
METHODS	In this randomized crossover trial , 14 consecutive patients ( 7 in each arm ) undergoing major spine surgery , under a background anesthetic of propofol ( 75 to 125 mcg/kg/min ) and remifentanil ( 0.1 to 0.2 mcg/kg/min ) , were randomly assigned to receive the sequence of inhalational agents studied : either DES-SEVO ( desflurane followed by sevoflurane ) ; or SEVO-DES ( sevoflurane followed by desflurane ) .
METHODS	Multiples ( 0.3 , 0.5 , and 0.7 ) of minimum alveolar concentration ( MAC ) of desflurane and sevoflurane were administered .
METHODS	After a washout period of 15 minutes using high fresh oxygen/air flows , each of the patients then received the other gas as the second agent .
METHODS	Cortical stimulation was achieved with a train of 5 equivalent square pulses , each 0.05 ms in duration , delivered at 2 ms intervals .
METHODS	MEP recordings were made in the upper limb ( UL ) from first dorsal interosseus and lower limb ( LL ) from tibialis anterior with subdermal needle electrodes .
RESULTS	At 0.3 MAC desflurane , there was no statistical significant difference in transcranial-evoked MEP amplitudes from the baseline in both UL and LL stimulation .
RESULTS	However , this was not the case for sevoflurane for which even a low concentration at 0.3 MAC significantly depressed MEP amplitudes of LL ( but not UL ) from baseline value .
RESULTS	Desflurane at 0.5 and 0.7 MAC depresses LL MEP to 58.4 % and 59.9 % of baseline , respectively ( P < 0.05 ) , whereas sevoflurane at 0.3 , 0.5 , and 0.7 MAC depresses LL MEP to 66.2 % , 41.3 % , and 25.3 % of baseline , respectively ( P < 0.05 ) .
RESULTS	There was no difference in latency of the responses at any MAC .
CONCLUSIONS	Inhalational anesthetic agents ( sevoflurane > desflurane ) suppress MEP amplitudes in a dose-dependent manner .
CONCLUSIONS	The use of 0.3 MAC of desflurane ( but not sevoflurane ) provided good MEP recordings acceptable for clinical interpretation for both upper and LLs .
CONCLUSIONS	The LL appears to be more sensitive to anesthetic-induced depression compared with the UL .
CONCLUSIONS	All patients studied had normal neurological examination hence , these results may not be applicable to those with preexisting deficits .

###25626448
BACKGROUND	Artemether-lumefantrine and artesunate-amodiaquine are first-line treatment for uncomplicated malaria in Cameroon .
BACKGROUND	No study has yet compared the efficacy of these drugs following the WHO recommended 42-day follow-up period .
BACKGROUND	The goal of this study was to compare the clinical efficacy , tolerability and safety of artesunate-amodiaquine ( ASAQ ) , artemether-lumefantrine ( AL ) and dihydroartemisinin piperaquine ( DHAP ) among children aged less than ten years in two malaria-endemic ecological regions of Cameroon .
METHODS	A three-arm , randomized , controlled , non-inferiority trial was conducted among children of either gender aged six months ( > 5kg ) to ten years ( n = 720 ) with acute uncomplicated Plasmodium falciparum infection .
METHODS	Parents/guardians of children provided consent prior to randomization to receive ASAQ , DHAP or AL in the ratio of 2:2:1 , respectively .
METHODS	Treatment outcome was assessed based on standard WHO 2003 classification after 42days of follow-up .
METHODS	The primary outcome was PCR-corrected day-42 cure rates .
METHODS	The non-inferiority , one-sided , lower limit asymptotic 97.5 % confidence interval ( CI ) on the difference in PCR-corrected cure rates of ASAQ and DHAP when compared to AL was accepted if the lower limit of the CI was greater than -10 % .
METHODS	Secondary outcomes were parasite and fever clearances and day 7 haemoglobin changes .
RESULTS	PCR-corrected PP cure rates of 96.7 , 98.1 and 96.3 , respectively , for AL , ASAQ and DHAP was observed .
RESULTS	The lower bound of the one-sided 97.5 % CI calculated around the difference between day-42 cure rate point estimates in AL and ASAQ groups , AL and DHAP groups were , -6 % and -4 % respectively .
RESULTS	There were no statistical significant differences in parasite or fever clearance times between treatments , although fever clearance pattern was different between ASAQ and DHAP .
RESULTS	No statistical significant differences were observed in the occurrence of adverse events among treatment groups .
CONCLUSIONS	ASAQ and DHAP are considered safe and tolerable and are not inferior to AL in the treatment of uncomplicated P. falciparum malaria in Cameroonian children .
BACKGROUND	NCT01845701 .

###24343823
OBJECTIVE	To study the effect of therapeutic hypothermia ( TH ) on deoxyribonucleic acid ( DNA ) damage and the neurodevelopmental outcome in term babies with perinatal asphyxia .
METHODS	Babies in the hypothermia group were cooled for the first 72 h , using gel packs .
METHODS	Rectal temperature of 33-34C was maintained .
METHODS	Blood sample was collected before , at 36 h and after completion of TH for assessment of comet assay and 8-hydroxy2-deoxyguanosine ( 8-OHdG ) .
METHODS	Infants were followed up till 12 months .
RESULTS	Baseline parameters were similar .
RESULTS	After 72 h , the hypothermia group showed lower olive tail moment ( 12.88 2.14 ) than the control group ( 22.16 5.26 ) ( p < 0.001 ) .
RESULTS	8-HDG levels increased significantly in the control group ( 1252.87 357.07 ) as compared to the hypothermia group ( 757.03 198.49 ) ( p < 0.001 ) .
RESULTS	Neurodevelopmental assessment at 12 months showed significantly low motor and mental developmental quotient in the control than hypothermia group .
CONCLUSIONS	TH reduces oxidative stress-induced DNA damage and improves neurodevelopmental outcome .
CONCLUSIONS	< Trial registration No : CTRI/2011/10 / 002094 >

###24642406
OBJECTIVE	To compare integrated automated load distributing band CPR ( iA-CPR ) with high-quality manual CPR ( M-CPR ) to determine equivalence , superiority , or inferiority in survival to hospital discharge .
METHODS	Between March 5 , 2009 and January 11 , 2011 a randomized , unblinded , controlled group sequential trial of adult out-of-hospital cardiac arrests of presumed cardiac origin was conducted at three US and two European sites .
METHODS	After EMS providers initiated manual compressions patients were randomized to receive either iA-CPR or M-CPR .
METHODS	Patient follow-up was until all patients were discharged alive or died .
METHODS	The primary outcome , survival to hospital discharge , was analyzed adjusting for covariates , ( age , witnessed arrest , initial cardiac rhythm , enrollment site ) and interim analyses .
METHODS	CPR quality and protocol adherence were monitored ( CPR fraction ) electronically throughout the trial .
RESULTS	Of 4753 randomized patients , 522 ( 11.0 % ) met post enrollment exclusion criteria .
RESULTS	Therefore , 2099 ( 49.6 % ) received iA-CPR and 2132 ( 50.4 % ) M-CPR .
RESULTS	Sustained ROSC ( emergency department admittance ) , 24h survival and hospital discharge ( unknown for 12 cases ) for iA-CPR compared to M-CPR were 600 ( 28.6 % ) vs. 689 ( 32.3 % ) , 456 ( 21.8 % ) vs. 532 ( 25.0 % ) , 196 ( 9.4 % ) vs. 233 ( 11.0 % ) patients , respectively .
RESULTS	The adjusted odds ratio of survival to hospital discharge for iA-CPR compared to M-CPR , was 1.06 ( 95 % CI 0.83-1 .37 ) , meeting the criteria for equivalence .
RESULTS	The 20 min CPR fraction was 80.4 % for iA-CPR and 80.2 % for M-CPR .
CONCLUSIONS	Compared to high-quality M-CPR , iA-CPR resulted in statistically equivalent survival to hospital discharge .

###24464530
BACKGROUND	Certain disorders , such as depression and anxiety , to which serotonin dysfunction is historically associated , are also associated with lower assessments of other people 's trustworthiness .
BACKGROUND	Serotonergic changes are known to alter cognitive responses to threatening stimuli .
BACKGROUND	This effect may manifest socially as reduced apparent trustworthiness of others .
BACKGROUND	Trustworthiness judgments can emerge from either direct observation or references provided by third parties .
OBJECTIVE	We assessed whether explicit judgments of trustworthiness and social influences on those judgments are altered by changes within serotonergic systems .
METHODS	We implemented a double-blind between-subject design where 20 healthy female volunteers received a single dose of the selective serotonin reuptake inhibitor ( SSRI ) citalopram ( 220 mg ) , while 20 control subjects ( matched on age , intelligence , and years of education ) received a placebo .
METHODS	Subjects performed a face-rating task assessing how trustworthy they found 153 unfamiliar others ( targets ) .
METHODS	After each rating , the subjects were told how other subjects , on average , rated the same target .
METHODS	The subjects then performed 30 min of distractor tasks before , unexpectedly , being asked to rate all 153 faces again , in a random order .
RESULTS	Compared to subjects receiving a placebo , subjects receiving citalopram rated targets as less trustworthy .
RESULTS	They also conformed more to opinions of others , when others rated targets to be even less trustworthy than subjects had initially indicated .
RESULTS	The two effects were independent of negative effects of citalopram on subjective state .
CONCLUSIONS	This is evidence that serotonin systems can mediate explicit assessment and social learning of the trustworthiness of others .

###24386101
OBJECTIVE	Sarcoplasmic reticulum ( SR ) Ca ( 2 + ) - handling proteins play an important role in myocardial dysfunction after acute ischemia/reperfusion injury .
OBJECTIVE	We hypothesized that nitrite would improve postresuscitation myocardial dysfunction by increasing nitric oxide ( NO ) generation and that the mechanism of this protection is related to the modulation of SR Ca ( 2 + ) - handling proteins .
METHODS	We conducted a randomized prospective animal study using male Sprague-Dawley rats .
METHODS	Cardiac arrest was induced by intravenous bolus of potassium chloride ( 40 g/g ) .
METHODS	Nitrite ( 1.2 nmol/g ) or placebo was administered when chest compression was started .
METHODS	No cardiac arrest was induced in the sham group .
METHODS	Hemodynamic parameters were monitored invasively for 90 minutes after the return of spontaneous circulation ( ROSC ) .
METHODS	Echocardiogram was performed to evaluate cardiac function .
METHODS	Myocardial samples were harvested 5 minutes and 1 hour after ROSC .
RESULTS	Myocardial function was significantly impaired in the nitrite and placebo groups after resuscitation , whereas cardiac function ( i.e. , ejection fraction and fractional shortening ) was significantly greater in the nitrite group than in the placebo group .
RESULTS	Nitrite administration increased the level of nitric oxide in the myocardium 5 min after resuscitation compared to the other two groups .
RESULTS	The levels of phosphorylated phospholamban ( PLB ) were decreased after resuscitation , and nitrite increased the phosphorylation of phospholamban compared to the placebo .
RESULTS	No significant differences were found in the expression of sarcoplasmic reticulum Ca ( 2 + ) ATPase ( SERCA2a ) and ryanodine receptors ( RyRs ) .
CONCLUSIONS	postresuscitation myocardial dysfunction is associated with the impairment of PLB phosphorylation .
CONCLUSIONS	Nitrite administered during resuscitation improves postresuscitation myocardial dysfunction by preserving phosphorylated PLB protein during resuscitation .

###24462012
BACKGROUND	Group medical clinics may improve diabetes and hypertension control , but data about dyslipidemia are limited .
BACKGROUND	We examined the impact of group medical clinics on lipids among patients with uncontrolled diabetes and hypertension .
METHODS	Prespecified secondary analysis of 239 veterans randomized to group medical clinics or usual care .
METHODS	Lipids were assessed at study baseline , midpoint , and end .
METHODS	We used linear mixed models to compare lipid levels between arms and generalized estimating equation models to compare low-density lipoprotein cholesterol ( LDL-C ) goal attainment .
METHODS	An additional post hoc analysis examined intensification of cholesterol-lowering medications in both arms .
RESULTS	At baseline , mean total cholesterol was 169.7 mg/dL ( SD 47.8 ) , LDL-C 98.2 mg/dL ( SD 41.7 ) , and high-density lipoprotein cholesterol ( HDL-C ) 39.3 mg/dL ( SD 13.0 ) .
RESULTS	Median baseline triglycerides were 131 mg/dL ( interquartile range 122 ) .
RESULTS	By study end , mean total cholesterol and LDL-C in group medical clinics were 14.2 mg/dL ( P = .01 ) and 9.2 mg/dL ( P = .02 ) lower than usual care , respectively ; 76 % of group medical clinic patients met goals for LDL-C , versus 61 % of usual care patients ( P = .02 ) .
RESULTS	Triglycerides and HDL-C remained similar between study arms .
RESULTS	Treatment intensification occurred in 52 % of group medical clinic patients , versus 37 % of usual care patients between study baseline and end ( P = .04 ) .
RESULTS	The mean statin dose was higher in group medical clinic patients at study midpoint and end .
CONCLUSIONS	Group medical clinics appear to enhance lipid management among patients with diabetes and hypertension .
CONCLUSIONS	This may be a result of greater intensification of cholesterol-lowering medications in group medical clinics relative to usual care .

###25015735
BACKGROUND	Red ginseng is prepared by steaming raw ginseng , a process believed to increase the pharmacological efficacy .
BACKGROUND	Further bioconversion of red ginseng through fermentation is known to increase its intestinal absorption and bioactivity , and bioconversion diminishes the toxicity of red ginseng 's metabolite .
BACKGROUND	This study was conducted to investigate the effects of daily supplementation with fermented red ginseng ( FRG ) on glycemic status in subjects with impaired fasting glucose or type 2 diabetes .
METHODS	This study was a four-week long , randomized , double-blind , placebo-controlled trial .
METHODS	Forty-two subjects with impaired fasting glucose or type 2 diabetes were randomly allocated to two groups assigned to consume either the placebo or fermented red ginseng ( FRG ) three times per day for four weeks .
METHODS	Fasting and postprandial glucose profiles during meal tolerance tests were assessed before and after the intervention .
RESULTS	FRG supplementation led to a significant reduction in postprandial glucose levels and led to an increase in postprandial insulin levels compared to the placebo group .
RESULTS	There was a consistently significant improvement in the glucose area under the curve ( AUC ) in the FRG group .
RESULTS	However , fasting glucose , insulin , and lipid profiles were not different from the placebo group .
CONCLUSIONS	Daily supplementation with FRG lowered postprandial glucose levels in subjects with impaired fasting glucose or type 2 diabetes .
BACKGROUND	ClinicalTrials.gov : NCT01826409 .

###24345834
OBJECTIVE	The aim of the study was to determine whether docosahexaenoic acid ( DHA ) supplementation improves the behavior of children with autism .
METHODS	A group of 3 - to 10-year-old children with autism were randomized in a double-blind fashion to receive a supplement containing 200 mg of DHA or a placebo for 6 months .
METHODS	The parents and the investigator completed the Clinical Global Impressions-Improvement scale to rate changes in core symptoms of autism after 3 and 6 months .
METHODS	The parents completed the Child Development Inventory and the Aberrant Behavior Checklist , and both parents and teachers completed the Behavior Assessment Scale for Children ( BASC ) at enrollment and after 6 months .
RESULTS	A total of 48 children ( 40 [ 83 % ] boys , mean age [ standard deviation ] 6.1 [ 2.0 ] years ) were enrolled ; 24 received DHA and 24 placebo .
RESULTS	Despite a median 431 % increase in total plasma DHA levels after 6 months , the DHA group was not rated as improved in core symptoms of autism compared to the placebo group on the CGI-I .
RESULTS	Based on the analysis of covariance models adjusted for the baseline rating scores , parents ( but not teachers ) provided a higher average rating of social skills on the BASC for the children in the placebo group compared to the DHA group ( P = 0.04 ) , and teachers ( but not parents ) provided a higher average rating of functional communication on the BASC for the children in the DHA group compared to the placebo group ( P = 0.02 ) .
CONCLUSIONS	Dietary DHA supplementation of 200 mg/day for 6 months does not improve the core symptoms of autism .
CONCLUSIONS	Our results may have been limited by inadequate sample size .

###24449716
OBJECTIVE	We evaluated the efficacy and safety of an early invasive strategy post-fibrinolysis in relation to glycoprotein ( GP ) IIb/IIIa inhibitor use .
METHODS	The Trial of Routine Angioplasty and Stenting after Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction ( TRANSFER-AMI ) randomised 1059 ST elevation myocardial infarction patients to an early invasive strategy or standard therapy post-fibrinolysis .
METHODS	The primary end point was the composite of death , reinfarction , recurrent ischaemia , new or worsening heart failure , or cardiogenic shock at 30 days .
METHODS	In this pre-specified analysis , we examined efficacy and safety outcomes of an early invasive strategy after stratification by GPIIb/IIIa inhibitor use , which was permitted during percutaneous coronary intervention ( PCI ) at the discretion of the treating physician .
RESULTS	A total of 695 patients ( 65.6 % ) received GPIIb/IIIa inhibitors .
RESULTS	There was significant heterogeneity ( p < 0.001 ) in the efficacy of an early invasive strategy compared to standard therapy , between the strata with GPIIb/IIIa inhibitor use ( primary end point 9.6 % vs 22.3 % respectively , p < 0.001 ) and without GPIIb/IIIa inhibitor use ( primary end point 14.8 % vs 10.4 % respectively , p = 0.21 ) .
RESULTS	Patients who received GPIIb/IIIa inhibitors had lower Global Registry of Acute Coronary Events ( GRACE ) risk scores compared to those without GPIIb/IIIa inhibitor use ( median 121 vs 130 , p < 0.001 ) .
RESULTS	After adjusting for the interaction between GRACE risk score and treatment assignment , the heterogeneity in the efficacy of an early invasive strategy with respect to GPIIb/IIIa inhibitor use was no longer significant ( p interaction = 0.08 ) .
CONCLUSIONS	The apparent difference in the efficacy of an early invasive strategy between GPIIb/IIIa inhibitor strata likely reflects an association between GPIIb/IIIa inhibitor use and baseline risk .
CONCLUSIONS	GPIIb/IIIa inhibitor use during PCI at the discretion of the treating physician does not appear to modulate the efficacy of an early invasive strategy post-fibrinolysis .
BACKGROUND	http://www.clinicaltrials.gov/ct2/show/NCT00164190 , NCT00164190 .

###25411141
OBJECTIVE	To determine the safety and efficacy of a 50 ns Q switched Nd YAG laser vs. a 5 ns Q switched Nd YAG laser for clearance of melasma .
OBJECTIVE	To compare subject satisfaction , efficacy , and comfort level between the two lasers .
METHODS	This is a prospective , randomized split face clinical study .
METHODS	The study was approved by the Scripps IRB .
METHODS	Ten healthy female subjects with moderate to severe melasma were enrolled .
METHODS	Each subject had three laser treatments one month apart .
METHODS	Patients were followed up approximately 1 month , 3 months , and 6 months after the final laser treatment .
METHODS	A treatment session consisted of a microdermabrasion , 1064 nm QS laser , and topicals .
METHODS	Subjects were asked to rate treatment pain based on a numerical scale range 0-10 ( 0 = no pain and 10 = worst pain ) .
METHODS	A melasma area and severity index ( MASI ) grading system was applied .
METHODS	Also , melanin measurements were acquired by a reflectance spectrophotometer .
METHODS	Side effects were documented during the study including post treatment erythema .
RESULTS	Eight patients completed the study .
RESULTS	Subjects showed improvement on both sides of the face .
RESULTS	From baseline to 1 month post the final laser treatment , the average MASI scores showed a 16 % reduction for the 50 ns QS 1064 nm laser vs. a 27 % reduction for the 5 ns QS 1064 nm laser ( both significant versus baseline pigment , P < 0.05 ) .
RESULTS	This difference in MASI scores between the two lasers was not statistically significant ( P = 0.87930 ) .
RESULTS	Laser treatments displayed mild erythema that resolved after one day .
RESULTS	The melanin meter measurements showed a reduction in pigment readings on both sides .
RESULTS	Three months after the final treatment there was some relapse in the melasma , as the mean pigment reduction fell to 12 % for the 50 ns laser and 11 % for the 5 ns laser .
RESULTS	By 3 months pigment reduction was not statistically significant for either laser , and no significant differences in pigment reduction were noted between the two pulse durations .
RESULTS	There was a statistically significant difference ( P < 0.05 ) in pain scores reported by the subjects ( scale 0-10 ) , the mean pain score for 50 ns QS 1064 nm laser was 1.2 and for the 5 ns QS 2.9 the score was 2.9 .
CONCLUSIONS	In this study , we showed that a combination of microdermabrasion , QS1064 nm laser , and topicals decreased the MASI and meter scores without clinically significant side effects .
CONCLUSIONS	Moreover , the longer pulsed Q switched 1064 nm laser i.e. ( 50 ns ) was associated with less pain than its shorter pulse width counterpart .

###25038558
BACKGROUND	Evidence supports that adequate treatment of hyperglycemia , hypercholesterolemia , and hypertension can reduce morbidity and mortality in people with diabetes , however achieving treatment goals remains elusive .
BACKGROUND	The majority of diabetes care occurs in the primary care setting ; however there are often missed opportunities for timely intervention during office visits .
BACKGROUND	This paper describes a systematic redesign of current diabetes treatment in primary care by implementing evidence-based protocols .
METHODS	This is a cluster randomized controlled trial using certified diabetes educators ( CDEs ) to intensify therapeutic management .
METHODS	Fifteen primary care practices from the University of Pittsburgh Medical Center were recruited .
METHODS	Practices were randomized to intervention ( implementation of diabetes management protocols ) or usual care .
METHODS	Eligibility criteria included diagnosis of type 2 diabetes at least one year prior to baseline and an A1C 7 % , LDLc 100 mg/dl or blood pressure 130/80 mmHg which were the goal levels established by the American Diabetes Association at study inception .
METHODS	Treatment was intensified according to preapproved protocols .
METHODS	Participants also received diabetes education during their visits .
METHODS	Research assessments were done at baseline , three , six and twelve months .
METHODS	Clinical visits were scheduled between research visits , as needed , to adjust medications .
METHODS	Primary outcomes were achievement of glycemic , blood pressure , or lipid control goals .
METHODS	Secondary outcomes included quality of life , medication and diabetes care satisfaction , medication adherence , and cost-effectiveness .
CONCLUSIONS	Results from this study will provide the evidence to support expanded roles for CDEs in primary care .
CONCLUSIONS	Using this model to deliver diabetes care may offer a more cost-effective approach for diabetes management .

###25513965
BACKGROUND	Long-term oral anticoagulant treatment is obligatory in patients with atrial fibrillation ( AF , score of CHADSVASc2 ) .
BACKGROUND	When these patients undergo percutaneous coronary intervention with a drug-eluting stent ( PCI-eS ) , there is also an indication for aspirin and clopidogrel treatment , according to the ESC Guidelines .
BACKGROUND	However , triple therapy has been known to increase the risk of bleeding complications .
BACKGROUND	Unfortunately , there is little prospective data available to resolve this issue .
BACKGROUND	Therefore , it is imperative that an optimal therapy for AF patients with indications of both anticoagulation and antiplatelet intervention to prevent thrombotic complications without increasing the risk of bleeding is found .
OBJECTIVE	This prospective , randomized , multicenter study is going to assess the hypothesis that in persistent or permanent AF patients ( score of CHADSVASc2 ) after PCI-eS , the combination therapy of oral anticoagulation ( warfarin ) and ticagrelor ( 90 mg/bid ) could reduce the risk of bleeding events .
METHODS	A multicenter , active-controlled , open-label , randomized trial is to be performed to evaluate dual antithrombotic therapy ( ticagrelor + warfarin ) in persistent or permanent AF patients ( score of CHADSVASc2 ) after PCI-eS versus the combination of triple antithrombosis ( clopidogrel + aspirin + warfarin ) .
METHODS	The primary endpoint is the overall bleeding up to 6 months , according to TIMI criteria and classifications .
METHODS	The secondary endpoints are the major bleeding events up to 6 months , according to TIMI criteria .
METHODS	The sample size is estimated at 296 .
CONCLUSIONS	This study is intended to provide information about the safety characteristics of warfarin and ticagrelor in persistent or permanent AF patients after PCI-eS .
CONCLUSIONS	No prospective randomized study has been conducted on the issue of antithrombotic therapy using warfarin and ticagrelor in these patients .
CONCLUSIONS	Therefore , the MANJUSRI trial will help to explore and determine a new potential therapeutic regimen for AF patients after PCI-eS .
BACKGROUND	Clinical Trials.gov # NCT02206815 , registered July 30 , 2014 .

###25220844
BACKGROUND	Acute stress produces behavioral and physiological changes modulated by central catecholamines ( CA ) .
BACKGROUND	Stress increases CA activity , and depletion of CA stores reduces responses to stress .
BACKGROUND	Increasing CA activity by administration of the dietary amino acid CA precursor tyrosine may increase responsiveness to stress .
BACKGROUND	This study determined whether tyrosine enhances the ability of humans to respond to severe stress .
METHODS	Severe psychological stress was generated during training at Survival , Evasion , Resistance , and Escape ( SERE ) School .
METHODS	The acute stressor consisted of two mock interrogations conducted during several days of simulated captivity .
METHODS	Seventy-eight healthy male and female military personnel participated in this double-blind , between-subjects study , in which they received either tyrosine ( 300mg/kg , N = 36 ) or placebo ( N = 36 ) .
METHODS	Tyrosine ( or placebo ) was administered in food bars in two doses of 150mg/kg each approximately 60min before each mock interrogation .
METHODS	Mood ( Profile of Mood States ) , saliva cortisol , and heart rate ( HR ) were assessed prior to stress exposure during a week of academic training preceding mock captivity and immediately following the mock interrogations .
RESULTS	The severe stress produced robust effects on mood ( i.e. , increased tension , depression , anger , fatigue , vigor , and confusion ; p < .001 ) , cortisol , and HR ( p < .001 ) .
RESULTS	Tyrosine increased anger ( p = .002 , ANOVA treatment condition by test session interaction ) during stress but had no other effects .
CONCLUSIONS	Tyrosine did not alter most subjective or physiological responses to severe acute stress , but it increased ratings of anger .
CONCLUSIONS	The modest increase in anger may be an adaptive emotional response in stressful environments .

###25257291
BACKGROUND	Org 25935 is a glycine transporter inhibitor that increases extracellular glycine levels and attenuates alcohol-induced dopaminergic activity in the nucleus accumbens .
BACKGROUND	In animal models , Org 25935 has dose-dependent effects on ethanol intake , preference , and relapse-like behavior without tolerance .
BACKGROUND	The current study aimed to translate these animal findings to humans by examining whether Org 25935 prevents relapse in detoxified alcohol-dependent patients .
METHODS	This was a multicenter , randomized , double-blind , placebo-controlled clinical trial .
METHODS	Adult patients diagnosed with alcohol dependence were randomly assigned to receive Org 25935 12 mg twice a day or placebo for 84 days .
METHODS	The primary end point was percentage heavy drinking days ( defined as 5 standard drinks per day for men and 4 for women ) .
METHODS	Secondary end points included other measures of relapse-related drinking behavior ( e.g. , drinks per day , time to relapse ) , as well as measures of global functioning , alcohol-related thoughts and cravings , and motivation .
RESULTS	A total of 140 subjects were included in the intent-to-treat analysis .
RESULTS	The trial was stopped approximately midway after a futility analysis showing that the likelihood of detecting a signal at study term was < 40 % .
RESULTS	There was no significant difference between Org 25935 and placebo on percentage heavy drinking days or any other measure of relapse-related drinking behavior .
RESULTS	Org 25935 showed no safety issues and was fairly well tolerated , with fatigue , dizziness , and transient visual events as the most commonly occurring side effects .
CONCLUSIONS	Org 25935 demonstrated no benefit over placebo in preventing alcohol relapse .
CONCLUSIONS	Study limitations and implications are discussed .

###26069259
OBJECTIVE	Less than 25 % of stroke patients arrive to an emergency department within the 3-hour treatment window .
OBJECTIVE	Stroke Warning Information and Faster Treatment ( SWIFT ) compared an interactive intervention ( II ) with enhanced educational ( EE ) materials on recurrent stroke arrival times in a prospective cohort of multiethnic stroke/transient ischemic attack survivors .
METHODS	A single-center randomized controlled trial ( 2005-2011 ) randomized participants to EE ( bilingual stroke preparedness materials ) or II ( EE plus in-hospital sessions ) .
METHODS	We assessed differences by randomization in the proportion arriving to emergency department < 3 hours , prepost intervention arrival < 3 hours , incidence rate ratio for total events , and stroke knowledge and preparedness capacity .
RESULTS	SWIFT randomized 1193 participants ( 592 EE , 601 II ) : mean age 63 years ; 50 % female , 17 % black , 51 % Hispanic , 26 % white .
RESULTS	At baseline , 28 % arrived to emergency department < 3 hours .
RESULTS	Over 5 years , first recurrent stroke ( n = 133 ) , transient ischemic attacks ( n = 54 ) , or stroke mimics ( n = 37 ) were documented in 224 participants .
RESULTS	Incidence rate ratio = 1.31 ( 95 % confidence interval = 1.05-1 .63 ; II to EE ) .
RESULTS	Among II , 40 % arrived < 3 hours versus 46 % EE ( P = 0.33 ) .
RESULTS	In prepost analysis , there was a 49 % increase in the proportion arriving < 3 hours ( P = 0.001 ) , greatest among Hispanics ( 63 % , P < 0.003 ) .
RESULTS	II had greater stroke knowledge at 1 month ( odds ratio = 1.63 ; 1.23-2 .15 ) .
RESULTS	II had higher preparedness capacity at 1 month ( odds ratio = 3.36 ; 1.86 , 6.10 ) and 12 months ( odds ratio = 7.64 ; 2.49 , 23.49 ) .
CONCLUSIONS	There was no difference in arrival < 3 hours overall between II and EE ; the proportion arriving < 3 hours increased in both groups and in race-ethnic minorities .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00415389 .

###24251969
BACKGROUND	Nonvariceal acute upper gastrointestinal bleeding ( AUGIB ) is often accompanied by post-discharge anaemia .
OBJECTIVE	To investigate whether iron treatment can effectively treat anaemia and to compare a 3-month regimen of oral iron treatment with a single administration of intravenous iron prior to discharge .
METHODS	Ninety-seven patients with nonvariceal AUGIB and anaemia were enrolled in a double-blind , placebo-controlled , randomised study .
METHODS	The patients were allocated to one of three groups , receiving a single intravenous administration of 1000 mg of iron ; oral iron treatment , 200 mg daily for 3 months ; or placebo , respectively .
METHODS	The patients were followed up for 3 months .
RESULTS	From week 4 onwards , patients receiving treatment had significantly higher haemoglobin levels compared with patients who received placebo only .
RESULTS	At the end of treatment , the proportion of patients with anaemia was significantly higher in the placebo group ( P < 0.01 ) than in the treatment groups .
RESULTS	Intravenous iron appeared to be more effective than oral iron in ensuring sufficient iron stores .
CONCLUSIONS	Iron treatment is effective and essential for treating anaemia after nonvariceal acute upper gastrointestinal bleeding .
CONCLUSIONS	The route of iron supplementation is less important in terms of the increase in haemoglobin levels .
CONCLUSIONS	Iron stores are filled most effectively if intravenous iron supplementation is administered ( ClinicalTrials.gov identifier : NCT00978575 ) .

###26521572
OBJECTIVE	To explore the impacts on the cognitive level of the children with mental retardation ( MR ) treated with JIN 's three scalp needling therapy and the training for cognitive and perceptual disturbance so as to seek the more effective therapeutic method for the treatment of MR in children .
OBJECTIVE	Methods Sixty-six MR children were randomized into a head-point needle-retaining therapy + training group ( group A ) and a training after acupuncture group ( group B ) .
OBJECTIVE	Seven cases and 12 cases were dropped in the two groups respectively .
OBJECTIVE	Twenty-six cases accomplished the treatment in the group A and 21 cases in the group B.
OBJECTIVE	In the group A , the points on the head were stimulated and the needles were retained ( 30 min after the general acupuncture , the needles on the body points were removed ; and those on the head points were retained for 1 h , including Sishenzhen , Naosanzhen , Zhisanzhen and Niesanzhen ) .
OBJECTIVE	Simultaneously , the training for the cognitive perceptual disturbance was combined .
OBJECTIVE	In the group B , 1 h after needle retaining at the body points and head points , all the needles were removed ; the training for the cognitive perceptual disturbance was followed .
OBJECTIVE	The treatment was given once a day , and the treatment for 3 months was required .
OBJECTIVE	Before and after treatment , the Wechsler intelligence scale for children ( WISC ) was used for evaluation and observation of verbal intelligence quotient ( VIQ ) , performance intelligence quotient ( PIQ ) and full-scale intelligence quotient ( TFIQ ) and score changes of 11 items such as information , picture vocabu ; lary , arithmetic , picture generalization , comprehension , etc. .
RESULTS	After treatment , FIQ , VIQ and PIQ scores were different significantly as compared with those before treatment ( all P < 0.01 ) .
RESULTS	In the group A , the results of picture vocabulary , animal egg laying , maze , block design and geometric figure were all improved significantly ( all P < 0.05 ) .
RESULTS	In the group B , the results of information , comprehension , block design and geometric figure were all improved significantly ( all P < 0.05 ) .
RESULTS	After treatment , concerning the value difference in FIQ and PIQ of the two groups ; the changes in the group A were more significant ( both P < 0.01 ) .
RESULTS	After treatment , the results of picture vocabulary and maze were improved significantly in the group A as compared with the group B ( both P < .
RESULTS	01 ) .
RESULTS	The IQ categories changed apparently after treatment in the two groups , toward the higher level in tendency generally , but without significant difference ( both P > 0.05 ) .
CONCLUSIONS	The simultaneous treatment with head point retaining of JIN 's three needling therapy and the training for cognitive and perceptual disturbance obviously improves children patients ' verbal comprehension , expression ability , hand-eye coordination ability , attention , logical reasoning ability and visual perception .
CONCLUSIONS	The efficacy is better than that in the treatment of the training after acupuncture .

###25605206
BACKGROUND	This study aimed to understand the relationship between knowledge level and behavior on breast care in Chinese students , so as to provide strategies for improving the health education of breast care and subsequently for aiding in breast cancer prevention .
METHODS	A self-designed questionnaire was used to evaluate breast care knowledge level and characterize related behavior .
METHODS	Correlation analysis was conducted for the knowledge level and behavior .
METHODS	The study was carried out using 597 female undergraduate students in medical and non-medical colleges in Wuhu , China .
RESULTS	The average score of breast care knowledge was 5.321.68 ( 5.621.68 and 5.001.68 for medical and non-medical students , respectively ) , with a greater score value for sophomores ( 5.591.72 ) than freshmen ( 5.181.65 ) .
RESULTS	The average score of breast care behavior was 2.211.13 , again with a greater value in sophomores ( 2.371.15 ) than freshmen ( 2.211.13 ) .
RESULTS	A significant positive correlation ( r = 0.231 , p < 0.01 ) between knowledge scores and behavior scores was observed .
RESULTS	In addition , various factors , including paying attention to breast care information , receiving breast self-examination guidance , TV program and Internet , were found to influence breast care knowledge .
CONCLUSIONS	In general , female undergraduate students lack of self-awareness of breast care with a low rate of breast self-examination .
CONCLUSIONS	It is necessary to carry out health education to improve early detection of breast cancer .

###24593810
OBJECTIVE	To volumetrically evaluate soft tissue changes of different ridge preservation techniques compared to spontaneous healing 6months after tooth extraction .
METHODS	In each of 40 patients , one single-rooted tooth was extracted and four treatment modalities were randomly assigned to the following groups ( n = 10 each ) : A ) - tricalcium-phosphate-particles with a polylactid coating ( - TCP ) , B ) demineralized bovine bone mineral with 10 % collagen covered with a collagen matrix ( DBBM-C/CM ) , C ) DBBM with 10 % collagen covered with an autogenous soft tissue punch graft ( DBBM-C/PG ) , D ) spontaneous healing ( control ) .
METHODS	Impressions were obtained before extraction and 6months later , casts were digitized and volumetric changes at the buccal soft tissues were determined .
METHODS	One-way anova was performed and pair-wise Wilcoxon rank sum test with Bonferroni-Holm method was applied for comparison of differences between two groups .
RESULTS	After 6months , horizontal contour changes accounted for -1.70.7 mm ( A ) , -1.20.5 mm ( B ) , -1.20.7 mm ( C ) and -1.80.8 mm ( D ) .
RESULTS	None of the group comparisons reached statistical significance .
CONCLUSIONS	Six months after tooth extraction all groups revealed a horizontal volume change in the buccal soft tissue contour .
CONCLUSIONS	Application of DBBM-C/CM or DBBM-C/PG reduced the amount of volume resorption compared to - TCP or spontaneous healing without reaching statistically significant difference .

###24261057
BACKGROUND	To address the high prevalence of neck dysfunction in helicopter aircrew , a 12-wk training program was designed to examine the effects on neck muscular strength and endurance .
METHODS	Subjects were recruited from Canadian Forces ( CF ) helicopter aircrew and randomized into either a neck coordination training program ( CTP ; N = 10 ) , an endurance training program ( ETP ; N = 11 ) , or a nontreatment control ( CON ; N = 8 ) .
METHODS	Baseline assessments determined maximal voluntary contraction ( MVC ) strength and endurance capacity using a submaximal contraction to fatigue at 70 % of their MVC for extension , flexion , and left ( Ltflx ) and right ( Rtflx ) lateral flexion .
METHODS	The ETP subjects performed dynamic contractions at 30 % of their MVC in the four testing directions using a head harness and Thera-band tubing .
METHODS	The CTP consisted of exercises that focused on strengthening the deep cervical musculature using the mass of the head as resistance and progressing to exercises that incorporated the superficial cervical muscles .
RESULTS	Post-intervention , the ETP achieved the only statistically significant increase in maximal force when compared to the CON ( 14.4 % ) .
RESULTS	Improved times to fatigue were achieved by the CTP for flexion ( 26.34 + / - 20.72 s ) , Ltflx ( 23.54 + / - 13.94 s ) , and Rtflx ( 28.72 + / - 4.88 s ) .
CONCLUSIONS	The provision of an ETP and CTP resulted in a positive trend toward improved maximal force and muscular endurance .
CONCLUSIONS	The greatest improvements in endurance and strength were found for those subjects assigned to the CTP treatment .
CONCLUSIONS	Our research demonstrates the importance of including a designed and supervised training program into the daily routine of helicopter aviators .

###24735616
BACKGROUND	Long-term sick leave has considerably negative impact on the individual and society .
BACKGROUND	Hence , the need to identify effective occupational rehabilitation programs is pressing .
BACKGROUND	In Norway , group based occupational rehabilitation programs merging patients with different diagnoses have existed for many years , but no rigorous evaluation has been performed .
BACKGROUND	The described randomized controlled trial aims primarily to compare two structured multicomponent inpatient rehabilitation programs , differing in length and content , with a comparative cognitive intervention .
BACKGROUND	Secondarily the two inpatient programs will be compared with each other , and with a usual care reference group .
METHODS	The study is designed as a randomized controlled trial with parallel groups .
METHODS	The Social Security Office performs monthly extractions of sick listed individuals aged 18-60 years , on sick leave 2-12 months , with sick leave status 50 % - 100 % due to musculoskeletal , mental or unspecific disorders .
METHODS	Sick-listed persons are randomized twice : 1 ) to receive one of two invitations to participate in the study or not receive an invitation , where the latter `` untouched '' control group will be monitored for future sick leave in the National Social Security Register , and 2 ) after inclusion , to a Long or Short inpatient multicomponent rehabilitation program ( depending on which invitation was sent ) or an outpatient cognitive behavioral therapy group comparative program .
METHODS	The Long program consists of 3 weeks with full rehabilitation days .
METHODS	The Short program consists of 4 +4 full days , separated by two weeks , in which a workplace visit will be performed if desirable .
METHODS	Three areas of rehabilitation are targeted : mental training , physical training and work-related problem solving .
METHODS	The primary outcome is number of sick leave days .
METHODS	Secondary outcomes include time until full sustainable return to work , health related quality of life , health related behavior , functional status , somatic and mental health , and perceptions of work .
METHODS	In addition , health economic evaluation will be performed , and the implementation of the interventions , expectations and experiences of users and service providers will be investigated with different qualitative methods .
BACKGROUND	ClinicalTrials.gov : NCT01926574 .

###24881730
BACKGROUND	Enzalutamide is an oral androgen-receptor inhibitor that prolongs survival in men with metastatic castration-resistant prostate cancer in whom the disease has progressed after chemotherapy .
BACKGROUND	New treatment options are needed for patients with metastatic prostate cancer who have not received chemotherapy , in whom the disease has progressed despite androgen-deprivation therapy .
METHODS	In this double-blind , phase 3 study , we randomly assigned 1717 patients to receive either enzalutamide ( at a dose of 160 mg ) or placebo once daily .
METHODS	The coprimary end points were radiographic progression-free survival and overall survival .
RESULTS	The study was stopped after a planned interim analysis , conducted when 540 deaths had been reported , showed a benefit of the active treatment .
RESULTS	The rate of radiographic progression-free survival at 12 months was 65 % among patients treated with enzalutamide , as compared with 14 % among patients receiving placebo ( 81 % risk reduction ; hazard ratio in the enzalutamide group , 0.19 ; 95 % confidence interval [ CI ] , 0.15 to 0.23 ; P < 0.001 ) .
RESULTS	A total of 626 patients ( 72 % ) in the enzalutamide group , as compared with 532 patients ( 63 % ) in the placebo group , were alive at the data-cutoff date ( 29 % reduction in the risk of death ; hazard ratio , 0.71 ; 95 % CI , 0.60 to 0.84 ; P < 0.001 ) .
RESULTS	The benefit of enzalutamide was shown with respect to all secondary end points , including the time until the initiation of cytotoxic chemotherapy ( hazard ratio , 0.35 ) , the time until the first skeletal-related event ( hazard ratio , 0.72 ) , a complete or partial soft-tissue response ( 59 % vs. 5 % ) , the time until prostate-specific antigen ( PSA ) progression ( hazard ratio , 0.17 ) , and a rate of decline of at least 50 % in PSA ( 78 % vs. 3 % ) ( P < 0.001 for all comparisons ) .
RESULTS	Fatigue and hypertension were the most common clinically relevant adverse events associated with enzalutamide treatment .
CONCLUSIONS	Enzalutamide significantly decreased the risk of radiographic progression and death and delayed the initiation of chemotherapy in men with metastatic prostate cancer .
CONCLUSIONS	( Funded by Medivation and Astellas Pharma ; PREVAIL ClinicalTrials.gov number , NCT01212991 . )

###25136038
OBJECTIVE	Emphasizing societal benefits of vaccines has been linked to increased vaccination intentions in adults .
OBJECTIVE	It is unclear if this pattern holds for parents deciding whether to vaccinate their children .
OBJECTIVE	The objective was to determine whether emphasizing the benefits of measles-mumps-rubella ( MMR ) vaccination directly to the vaccine recipient or to society differentially impacts parents ' vaccine intentions for their infants .
METHODS	In a national online survey , parents ( N = 802 ) of infants < 12 months old were randomly assigned to receive 1 of 4 MMR vaccine messages : ( 1 ) the Centers for Disease Control and Prevention Vaccine Information Statement ( VIS ) , ( 2 ) VIS and information emphasizing the MMR vaccine 's benefits to the child , ( 3 ) VIS and information emphasizing societal benefits , or ( 4 ) VIS and information emphasizing benefits both to the child and society .
METHODS	Parents reported their likelihood of vaccinating their infants for MMR on a response scale of 0 ( extremely unlikely ) to 100 ( extremely likely ) .
RESULTS	Compared with the VIS-only group ( mean intention = 86.3 ) , parents reported increased vaccine intentions for their infants when receiving additional information emphasizing the MMR vaccine 's benefits either directly to the child ( mean intention = 91.6 , P = .01 ) or to both the child and society ( mean intention = 90.8 , P = .03 ) .
RESULTS	Emphasizing the MMR vaccine 's benefits only to society did not increase intentions ( mean intention = 86.4 , P = .97 ) .
CONCLUSIONS	We did not see increases in parents ' MMR vaccine intentions for their infants when societal benefits were emphasized without mention of benefits directly to the child .
CONCLUSIONS	This finding suggests that providers should emphasize benefits directly to the child .
CONCLUSIONS	Mentioning societal benefits seems to neither add value to , nor interfere with , information highlighting benefits directly to the child .

###24767206
OBJECTIVE	To study the efficacy and safety of tirofiban in patients with acute non-ST - segment elevation myocardial infarction ( NSTEMI ) without early reperfusion intervention .
METHODS	A total of 151 NSTEMI patients without early reperfusion intervention were enrolled in the study and randomized to the tirofiban group ( n = 76 ) and the control group ( n = 75 ) .
METHODS	Coronary angiography was performed at day 3 and day 7 , while percutaneous coronary intervention ( PCI ) was performed when necessary .
METHODS	Parameters including thrombolysis in myocardial infarction ( TIMI ) flow , bleeding complications and clinic events within 30 days were compared between the two groups .
RESULTS	Before PCI , no increase in the percentage of patient with TIMI flow better than TIMI-2 was observed by the treatment of tirofiban ( 69.3 % vs 78.9 % , P = 0.10 ) .
RESULTS	While after PCI , significant increase in the percentage of patient with TIMI flow better than TIMI-2 was manifested in the tirofiban group ( 96.0 % vs 100.0 % , P = 0.04 ) .
RESULTS	Tirofiban treatment also significantly decreased the rate of poor myocardial perfusion after PCI ( 19.7 % vs 34.7 % , P = 0.04 ) .
RESULTS	There were 0 and 4 major adverse cardiovascular events ( MACE ) within 30 days observed in the tirofiban group and the control group ( 0.0 % vs 5.3 % , P = 0.05 ) .
RESULTS	No difference between the two groups was found in the bleeding complications within 30 days including the mild hemorrhage ( 5 vs 4 cases , P = 0.75 ) , severe hemorrhage ( 2 vs 1 cases , P = 0.56 ) or severe thrombocytopenia ( 2 vs 0 cases , P = 0.49 ) .
CONCLUSIONS	Tirofiban treatment does not increase the bleeding complications in NSTEMI patients without early PCI .
CONCLUSIONS	Tirofiban can improve the TIMI flow and the myocardial perfusion after PCI with less MACE within 30 days .

###25833980
BACKGROUND	The International Lipid-Based Nutrient Supplements Project developed a small-quantity ( 20 g/d ) lipid-based nutrient supplement ( LNS ) for pregnant and lactating women .
OBJECTIVE	We evaluated the effects of prenatal LNS supplementation on fetal growth .
METHODS	In a community-based , partially double-blind , individually randomized controlled trial , 1320 women 20 wk pregnant received 60 mg Fe/400 g folic acid ( IFA ) , or 1-2 Recommended Dietary Allowances of 18 micronutrients , including 20 mg Fe ( MMN ) , or LNS with the same micronutrients as the MMN group , plus 4 minerals and macronutrients contributing 118 kcal ( LNS ) daily until delivery .
METHODS	Fetal growth was compared across groups by using intention-to-treat analysis .
METHODS	The primary outcome was birth length .
RESULTS	This analysis included 1057 women ( IFA = 349 , MMN = 354 , LNS = 354 ) .
RESULTS	Groups did not differ significantly in mean birth length , length-for-age z score ( LAZ ) , head circumference , or percentage low birth length but differed in mean birth weight ( P = 0.044 ) , weight-for-age z score ( WAZ ; P = 0.046 ) , and BMI-for-age z score ( BMIZ ; P = 0.040 ) , with a trend toward differences in low birth weight ( P = 0.069 ) .
RESULTS	In pairwise comparisons , the LNS group had greater mean birth weight ( +85 g ; P = 0.040 ) , WAZ ( +0.19 ; P = 0.045 ) , and BMIZ ( +0.21 ; P = 0.035 ) and a lower risk of low birth weight ( RR : 0.61 , 95 % CI : 0.39 , 0.96 ; P = 0.032 ) than did the IFA group .
RESULTS	The other group differences were not significant .
RESULTS	The effect of intervention was modified by mother 's parity , age , height , baseline hemoglobin , household food insecurity , and child sex , with parity being the most consistent modifier .
RESULTS	Among primiparous women ( IFA = 131 ; MMN = 110 ; LNS = 128 ) , the LNS group had greater mean birth length ( +0.91 cm ; P = 0.001 ) , LAZ ( +0.47 ; P = 0.001 ) , weight ( +237 g ; P < 0.001 ) , WAZ ( +0.56 ; P < 0.001 ) , BMIZ ( +0.52 ; P < 0.001 ) , head circumference ( 0.50 cm ; P = 0.017 ) , and head circumference-for-age z score ( +0.40 ; P = 0.022 ) than did the IFA group ; similar differences were found when comparing the LNS and MMN groups among primiparous women , and no group differences were found among multiparous women .
CONCLUSIONS	Prenatal LNS supplementation can improve fetal growth among vulnerable women in Ghana , particularly primiparous women .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT00970866 .

###24500154
BACKGROUND	Nitrate , which is an inorganic anion abundant in vegetables , increases the efficiency of isolated human mitochondria .
BACKGROUND	Such an effect might be reflected in changes in the resting metabolic rate ( RMR ) and formation of reactive oxygen species .
BACKGROUND	The bioactivation of nitrate involves its active accumulation in saliva followed by a sequential reduction to nitrite , nitric oxide , and other reactive nitrogen species .
OBJECTIVE	We studied effects of inorganic nitrate , in amounts that represented a diet rich in vegetables , on the RMR in healthy volunteers .
METHODS	In a randomized , double-blind , crossover study , we measured the RMR by using indirect calorimetry in 13 healthy volunteers after a 3-d dietary intervention with sodium nitrate ( NaNO ) or a placebo ( NaCl ) .
METHODS	The nitrate dose ( 0.1 mmol kg d ) corresponded to the amount in 200-300 g spinach , beetroot , lettuce , or other vegetable that was rich in nitrate .
METHODS	Effects of direct nitrite exposure on cell respiration were studied in cultured human primary myotubes .
RESULTS	The RMR was 4.2 % lower after nitrate compared with placebo administration , and the change correlated strongly to the degree of nitrate accumulation in saliva ( r = 0.71 ) .
RESULTS	The thyroid hormone status , insulin sensitivity , glucose uptake , plasma concentration of isoprostanes , and total antioxidant capacity were unaffected by nitrate .
RESULTS	The administration of nitrite to human primary myotubes acutely inhibited respiration .
CONCLUSIONS	Dietary inorganic nitrate reduces the RMR .
CONCLUSIONS	This effect may have implications for the regulation of metabolic function in health and disease .

###24862633
OBJECTIVE	To compare health-related quality-of-life ( HRQoL ) outcomes for robot-assisted laparoscopic radical cystectomy ( RARC ) with those of traditional open radical cystectomy ( ORC ) in a prospective randomised fashion .
METHODS	This was a prospective randomised clinical trial evaluating the HRQoL for ORC vs RARC in consecutive patients from July 2009 to June 2011 .
METHODS	We administered the Functional Assessment of Cancer Therapy-Vanderbilt Cystectomy Index questionnaire , validated to assess HRQoL , preoperatively and then at 3 , 6 , 9 and 12 months postoperatively .
METHODS	Scores for each domain and total scores were compared in terms of deviation from preoperative values for both the RARC and the ORC cohorts .
METHODS	Multivariate linear regression was used to assess the association between the type of radical cystectomy and HRQoL .
RESULTS	At the time of the study , 47 patients had met the inclusion criteria , with 40 patients being randomised for analysis .
RESULTS	The cohorts consisted of 20 patients undergoing ORC and 20 undergoing RARC , who were balanced with respect to baseline demographic and clinical features .
RESULTS	Univariate analysis showed a return to baseline scores at 3 months postoperatively in all measured domains with no statistically significant difference among the various domains between the RARC and the ORC cohorts .
RESULTS	Multivariate analysis showed no difference in HRQoL between the two approaches in any of the various domains , with the exception of a slightly higher physical well-being score in the RARC group at 6 months .
CONCLUSIONS	There were no significant differences in the HRQoL outcomes between ORC and RARC , with a return of quality of life scores to baseline scores 3 months after radical cystectomy in both cohorts .

###25841317
OBJECTIVE	To assess the efficacy of corneal cross-linking ( CXL ) as an adjuvant to appropriate antifungal therapy in nonresolving deep stromal fungal keratitis .
METHODS	Randomized clinical trial .
METHODS	Eyes with culture-positive deep stromal fungal keratitis not responding to appropriate medical therapy for a period of 2 weeks were randomized to receive either adjuvant CXL or no additional treatment .
METHODS	Antifungal medical therapy was continued in both groups .
METHODS	The prespecified primary outcome was treatment failure at 6 weeks after enrollment , defined as perforation and/or increase in ulcer size by 2 mm .
RESULTS	The trial was stopped before full enrollment because of a marked difference in the rate of perforation between the 2 groups .
RESULTS	Of the 13 cases enrolled in the study , 6 were randomized to the CXL group and 7 to the non-CXL group .
RESULTS	Five eyes in the CXL group and 3 eyes in the non-CXL group experienced treatment failure by 6 weeks ( P = .56 ) .
RESULTS	In a secondary analysis , the CXL group experienced more perforations than the non-CXL group ( 4 vs 0 , respectively ; P = .02 ) .
CONCLUSIONS	CXL used as adjuvant therapy for recalcitrant deep stromal fungal keratitis did not improve outcomes .

###24367946
BACKGROUND	Effects of palm olein ( POL ) on calcium and fat metabolic balance and gastrointestinal ( GI ) tolerance have been clinically evaluated but its use in combination with palm kernel oil ( PKO ) , and canola oil has not been similarly assessed in infants .
METHODS	Calcium and fat balance and GI tolerance were evaluated in 33 healthy term infants ( age = 68-159 d ) in a randomized , double-blinded , 14 d crossover trial at a day care center in Salvador , Brazil ; followed by a 4d hospital ward metabolic balance study in 17 of the male subjects .
METHODS	The study compared two commercially available milk-based powdered formulas in Brazil ; one containing POL ( 44 % of total fat ) , PKO ( 21.7 % ) and canola oil ( 18.5 % ) as predominant fats ( PALM ) , and the other containing none ( NoPALM ) .
METHODS	Occasional human milk ( HM ) supplementation was allowed at home .
RESULTS	Formula and HM intakes , and growth were not different ( p > 0.05 ) .
RESULTS	Calcium absorption ( % ) for infants fed NoPALM ( 58.8 16.7 % ; means SD ) was higher ( p = 0.023 ) than those fed PALM ( 42.1 19.2 % ) , but was not significant ( p = 0.104 ) when calcium intake was used as a covariate .
RESULTS	Calcium intake was higher ( p < 0.001 ) in NoPALM versus PALM fed infants .
RESULTS	However , calcium retention ( % ) was higher in infants fed NoPALM compared to PALM with ( p = 0.024 ) or without ( p = 0.015 ) calcium intake as a covariate .
RESULTS	Fat absorption ( % ) for NoPALM was greater than PALM fed infants ( NoPALM = 96.9 1.2 > PALM = 95.1 1.5 ; p = 0.020 in Study Period I ) .
RESULTS	Mean rank stool consistency was softer in infants fed NoPALM versus PALM ( p < 0.001 ; metabolic period ) .
RESULTS	Adverse events , spit-up/vomit , fussiness and gassiness were not different ( p > 0.05 ) .
RESULTS	Formula acceptability was high and comparable for both formula feedings , regardless of HM supplementation .
CONCLUSIONS	Term infants fed PALM based formula ( containing palm olein , palm kernel and canola oils ) demonstrated lower calcium retention and fat absorption , and less softer stool consistency versus infants fed NoPALM based formula .
CONCLUSIONS	Study suggested formula fat differences may affect GI function in infants .

###25356881
OBJECTIVE	Exacerbations of COPD requiring hospital admission have important clinical and societal implications .
OBJECTIVE	We sought to investigate the incidence , recurrence , risk factors , and mortality of patients with COPD exacerbations requiring hospital admission compared with those without hospital admission during 3-year follow-up .
OBJECTIVE	Patients with COPD ( N = 2,138 ) were identified from the Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints ( ECLIPSE ) observational cohort .
METHODS	An analysis of time to first event of hospital admission was performed using Kaplan-Meier curves and Cox proportional hazard regression adjusting for possible confounders .
RESULTS	Of the 2,138 patients , 670 ( 31 % ) reported a total of 1,452 COPD exacerbations requiring hospital admission during the study period ; 313 patients ( 15 % ) reported multiple events .
RESULTS	A prior history of exacerbation of COPD requiring hospital admission was the factor associated with the highest risk of a new hospitalization for exacerbation ( hazard ratio , 2.71 ; 95 % CI , 2.24-3 .29 ; P < .001 ) .
RESULTS	Other risk factors included more severe airflow limitation , poorer health status , older age , radiologic evidence of emphysema , and higher WBC count .
RESULTS	Having been hospitalized for exacerbation significantly increased the risk of mortality ( P < .001 ) .
CONCLUSIONS	Exacerbations of COPD requiring hospital admission occur across all stages of airflow limitation and are a significant prognostic factor of reduced survival across all COPD stages .
CONCLUSIONS	Patients with COPD at a high risk for hospitalization can be identified by their past history for similar events , and other factors , including the severity of airflow limitation , poor health status , age , presence of emphysema , and leukocytosis .
BACKGROUND	ClinicalTrials.gov ; No. : NCT00292552 ; URL : www.clinicaltrials.gov .

###24645912
BACKGROUND	Friction blister research has focused on prevention and treatment approaches rather than exploring the pathophysiology of the friction blister .
BACKGROUND	Increased skin hydration has been purported to be a key risk factor in friction blister development .
BACKGROUND	This study aimed to test the effect of increased skin surface hydration on the risk of friction blister creation .
METHODS	The skin on one foot was hydrated by soaking the foot in water .
METHODS	Intermittent loading was carried out until an observable change of 3C was evident using infrared thermography .
METHODS	The contra lateral foot acted as a control .
METHODS	Skin hydration and elasticity was measured using electrical capacitance and negative pressure respectively .
RESULTS	The rate of temperature change of the hydrated group was significantly greater than that of the non-hydrated foot group ( P = 0.001 ) and showed a strong positive correlation ( r = 0.520 ) with skin surface hydration .
RESULTS	Weak negative correlations were seen between skin elasticity and rate of temperature change in response to load application ( r = -0.166 ) and skin surface hydration and elasticity at baseline ( r = -0.195 ) .
CONCLUSIONS	In controlled experimental conditions increased skin surface hydration increases the rate of temperature change of the skin in response to load application and consequently increases the risk of blister creation .

###24884934
BACKGROUND	Foods that enhance satiety can help consumers to resist environmental cues to eat , and improve the nutritional quality of their diets .
BACKGROUND	Viscosity generated by oat - glucan , influences gastrointestinal mechanisms that mediate satiety .
BACKGROUND	Differences in the source , processing treatments , and interactions with other constituents in the food matrix affect the amount , solubility , molecular weight , and structure of the - glucan in products , which in turn influences the viscosity .
BACKGROUND	This study examined the effect of two types of oatmeal and an oat-based ready-to-eat breakfast cereal ( RTEC ) on appetite , and assessed differences in meal viscosity and - glucan characteristics among the cereals .
METHODS	Forty-eight individuals were enrolled in a randomized crossover trial .
METHODS	Subjects consumed isocaloric breakfast meals containing instant oatmeal ( IO ) , old-fashioned oatmeal ( SO ) or RTEC in random order at least a week apart .
METHODS	Each breakfast meal contained 218kcal ( 150kcal cereal , and 68kcal milk ) Visual analogue scales measuring appetite were completed before breakfast , and over four hours , following the meal .
METHODS	Starch digestion kinetics , meal viscosities , and - glucan characteristics for each meal were determined .
METHODS	Appetite responses were analyzed by area under the curve .
METHODS	Mixed models were used to analyze response changes over time .
RESULTS	IO increased fullness ( p = 0.04 ) , suppressed desire to eat ( p = 0.01 ) and reduced prospective intake ( p < 0.01 ) more than the RTEC over four hours , and consistently at the 60minute time-point .
RESULTS	SO reduced prospective intake ( p = 0.04 ) more than the RTEC .
RESULTS	Hunger scores were not significantly different except that IO reduced hunger more than the RTEC at the 60minute time-point .
RESULTS	IO and SO had higher - glucan content , molecular weight , gastric viscosity , and larger hydration spheres than the RTEC , and IO had greater viscosity after oral and initial gastric digestion ( initial viscosity ) than the RTEC .
CONCLUSIONS	IO and SO improved appetite control over four hours compared to RTEC .
CONCLUSIONS	Initial viscosity of oatmeal may be especially important for reducing appetite .

###25945555
BACKGROUND	In-water resuscitation ( IWR ) is recommended in the 2010 guidelines of the European Resuscitation Council .
BACKGROUND	As IWR represents a physical challenge to the rescuer , a novel Rescue Tube device with an integrated `` Oxylator '' resuscitator might facilitate IWR .
BACKGROUND	The aim of the present study was the assessment of IWR using the novel Rescue Tube device .
METHODS	Tidal and minute volumes were recorded using a modified Laerdal Resusci Anne mannequin .
METHODS	Furthermore , rescue time , water aspiration , submersions , and physical exertion were assessed .
METHODS	In this randomized cross-over trial , 17 lifeguards performed four rescue maneuvers over a 100-m distance in open water in random order : no ventilation ( NV ) , mouth-to-mouth ventilation ( MMV ) , Oxylator-aided mask ventilation ( OMV ) , and Oxylator-aided laryngeal tube ventilation ( OLTV ) .
RESULTS	OLTV resulted in effective ventilation over the entire rescue distance with the highest mean minute volumes ( NV 0 , MMV 2.9 , OMV 4.1 , OLTV 7.6 L min ( -1 ) ) .
RESULTS	NV was the fastest rescue maneuver while IWR prolonged the rescue maneuver independently of the method of ventilation ( mean total rescue time : NV 217 , MMV 280 , OMV 292 , OLTV 290 s ) .
RESULTS	Aspiration of substantial amounts of water occurred only during MMV ( mean NV 20 , MMV 215 , OMV 15 , OLTV 6 ml ) .
RESULTS	NV and OLTV were rated as moderately challenging by the lifeguards , whereas MMV and OMV were rated as substantially demanding on a 0-10 visual analog scale ( NV 5.3 , MMV 7.8 , OMV 7.6 , OLTV 5.9 ) .
CONCLUSIONS	The device might facilitate IWR by providing effective ventilation with minimal aspiration and by reducing physical effort .
CONCLUSIONS	Another advantage is the possibility of delivering 100 % oxygen .

###25026889
BACKGROUND	Cervical cancer is a frequently diagnosed cancer in women worldwide .
BACKGROUND	Despite having easy preventive and therapeutic approaches , it is an important cause of mortality among women .
METHODS	The CRICERVA study is a cluster clinical trial which assigned one of three interventions to the target population registered in Cerdanyola , Barcelona .
METHODS	Among the 5,707 resident women aged 60 to 70 years in the study area , women with no record of cervical cytology over the last three years were selected .
METHODS	The study included four arms : three interventions all including a pre-assigned date for screening visit and i ) personalized invitation letter ; ii ) adding to i ) an informative leaflet ; and , iii ) in addition to ii ) a personalized appointment reminder phone call , and iv ) no specific action taken ( control group ) .
METHODS	Participants were offered a personal interview about social-demographic characteristics and about screening attitudes .
METHODS	Cervical cytology and HPV DNA test ( HC2 ) were offered as screening tests .
METHODS	In the case of screening positive in any of these tests , the women were followed up until a full diagnosis could be obtained .
METHODS	The effect size of each study arm was estimated as the absolute gain in coverage between the original coverage and the final coverage .
RESULTS	From the intervention groups ( 4,775 women ) , we identified 3,616 who were not appropriately screened , of which 2,560 women answered the trial call and 1,376 were amenable to screening .
RESULTS	HPV was tested in 920 women and cervical cytology in all 1,376 .
RESULTS	Overall , there was an absolute gain in coverage of 28.8 % in the intervention groups compared to 6 % in the control group .
RESULTS	Coverage increased from 51.2 % to 76.0 % in strategy i ) ; from 47.4 % to 79.0 % in strategy ii ) and from 44.5 % to 74.6 % in strategy iii ) .
RESULTS	Lack of information about the relevance of screening was the most important factor for not attending the screening program .
CONCLUSIONS	The study confirms that actively contacting women and including a date for a screening visit , notably increased participation in the screening program .
CONCLUSIONS	Efforts to improve health education in preventative activities are warranted .
BACKGROUND	Clinical Trials.gov Identifier NCT01373723 .
BACKGROUND	Registered 14 June 2011 .

###24595550
BACKGROUND	This multi-center , phase III trial assesses the efficacy of daikenchuto ( TU-100 ) on gastrointestinal disorders after hepatic resection ( UMIN Registration No. 000003103 ) .
METHODS	A total of 231 patients , who underwent hepatic resection at 26 Japanese centers , were enrolled .
METHODS	Patients were randomly assigned to receive either oral doses ( 15 g/day , three times a day ) of TU-100 or placebo control from preoperative day 3 to postoperative day 10 , except on the day of surgery .
METHODS	Primary end points were the time from extubation until the first postoperative bowel movement ( FBM-T ) , serum C-reactive protein ( CRP ) and ammonia levels .
RESULTS	Finally , 209 patients ( TU-100 : n = 108 , placebo : n = 101 ) were included in the statistical analysis .
RESULTS	The median FBM-T was 88.2 h ( 95 % CI 74.0-94 .1 ) in the TU-100 group and 93.1 h ( 95 % CI 83.3-99 .4 ) in the placebo group , demonstrating that TU-100 accelerated the time to first bowel movement significantly more than placebo control .
RESULTS	Serum CRP levels did not differ significantly during the study period , although serum CRP levels in the TU-100 group tended to be lower than those in the placebo group in patients with grade B liver damage .
RESULTS	Meanwhile , the two groups had similar serum ammonia levels .
RESULTS	TU-100-related serious adverse events did not occur during the study .
CONCLUSIONS	TU-100 appears to improve gastrointestinal dysmotility and reduce serum CRP levels in patients with grade B liver damage after hepatectomy .
CONCLUSIONS	TU-100 is an effective treatment option after hepatic resection in patients with liver cancer .

###25643051
OBJECTIVE	This study was aimed at evaluating the clinical efficacy and safety of transcutaneous electrical acupoint stimulation ( TEAS ) to treat muscle spasticity after brain injury ( Chinese Clinical Trial Registry : ChiCTR-TRC-11001310 ) .
METHODS	A total of 60 patients with muscle spasticity after brain injury were randomized to the following 3 groups : 100 , 2 , and 0 Hz ( sham ) TEAS .
METHODS	The acupoints Hegu ( LI4 ) -- Yuji ( LU10 ) and Zusanli ( ST36 ) -- Chengshan ( BL57 ) on the injured side were stimulated at 0 , 2 , or 100 Hz , 5 times per week for 4 weeks .
METHODS	The patients were followed up for 1 and 2 months after the treatments .
METHODS	The effects of the treatments on muscle spasticity at the wrist , thumb , the other 4 fingers , elbow , shoulder , knee , and ankle were evaluated by the Modified Ashworth Scale , and the effects on disability were assessed by the Disability Assessment Scale .
METHODS	The walking capability was evaluated by the Holden functional ambulation classification score .
METHODS	The overall performance was assessed by the Global Assessment Scale score and the improved Barthel Index .
METHODS	The safety of the treatments administered was also monitored .
RESULTS	The wrist spasticity was significantly reduced from baseline at weeks 2 , 3 , and 4 of treatment and at the 1 - and 2-month follow-up visits in the 100 Hz group ( P < 0.01 ) .
RESULTS	Compared with 2 Hz or sham TEAS , 100 Hz TEAS decreased wrist spasticity at weeks 2 , 3 , and 4 of treatment and 1 month after treatment ( P < 0.001 ) .
RESULTS	The other endpoints were not affected by the treatments .
RESULTS	No treatment-emergent adverse events were reported during treatments and follow-up visits .
CONCLUSIONS	TEAS appears to be a safe and effective therapy to relieve muscle spasticity after brain injury , although large-scale studies are required to further verify the findings .
BACKGROUND	Chinese Clinical Trial Registry ChiCTR-TRC-11001310 http://www.chictr.org .

###25176152
OBJECTIVE	In the emergency department ( ED ) , intravenous ( IV ) catheter placement is one of the most frequent interventions and may be a real challenge in some conditions .
OBJECTIVE	Improvement of the success rate with new technology represents a great opportunity .
OBJECTIVE	This randomized controlled trial aimed to show the superiority of AccuVein to cannulate veins in adults compared to routine care .
METHODS	After giving written consent , patients were randomized into two groups : routine IV catheter insertion or insertion guided by the AccuVein , which is a hand-held instrument displaying laser light to optimize visualization of veins .
METHODS	The primary outcome was the time to successful placement of catheters .
METHODS	Secondary outcomes included the number of attempts , the rate of failure , technique-related pain , occurrence of movements , and efficiency of IV cannulation as perceived by the operator when using the AccuVein device .
METHODS	Results are given as mean and bootstrapped 95 % confidence interval ( CI ) and percentages .
METHODS	p-values of < 0.05 were considered significant .
RESULTS	A total of 266 six patients were included , with 157 randomized to routine cannulation and 115 to AccuVein .
RESULTS	Patient characteristics were similar .
RESULTS	Time to successful placement of IV catheter ( routine , 98 seconds , 95 % CI = 85 to 113 seconds ; and AccuVein , 119 seconds , 95 % CI = 93 to 154 seconds ) was not different between groups ( p = 0.24 ) .
RESULTS	Secondary outcomes ( failure and pain ) did not significantly differ , except for movements , which were more frequent when using the AccuVein device ( 19.1 % vs. 10.2 % , p = 0.05 ) .
RESULTS	Evaluation of the AccuVein by operators was more often negative than positive .
CONCLUSIONS	Use of the AccuVein did not improve IV cannulation in nonselected ED patients .

###24788028
OBJECTIVE	Past literature documents many individual predictors of treatment engagement among mental health clients in community settings , but few studies have examined clinic characteristics that may be associated with treatment engagement .
OBJECTIVE	With data from a patient activation and self-management trial , this study examined the variation in demographic and clinic characteristics across community mental health clinics and whether this variation predicted differences in treatment engagement in mental health services .
METHODS	Chart reviews were conducted for 638 clients of 12 community mental health clinics .
METHODS	Client attendance records were collected for a one-year period to examine engagement ( defined as the ratio of kept versus scheduled appointments ) .
METHODS	Adjusting for client variability , the investigators examined which clinic-level characteristics were associated with treatment engagement .
RESULTS	Clinics varied significantly in their clients ' demographic characteristics and engagement in mental health care .
RESULTS	Providing case management and offering transportation vouchers or free parking at the clinic were associated with lower engagement .
RESULTS	However , offering outreach was associated with greater engagement .
CONCLUSIONS	The results of this study suggest that certain clinic characteristics are associated with engagement in mental health services .
CONCLUSIONS	These results demonstrate the difficulties faced by community mental health clinics in reducing no-show rates even in the face of strong efforts to improve engagement .

###25450083
OBJECTIVE	Little is known about whether probiotics can affect outcomes of patients with cirrhosis and hepatic encephalopathy ( HE ) .
OBJECTIVE	We assessed the efficacy of a probiotic preparation in preventing the recurrence of HE ( primary outcome ) and reducing the number of hospitalizations and severity of liver disease in patients with cirrhosis .
METHODS	We performed a double-blind trial at a tertiary care hospital in India .
METHODS	Patients with cirrhosis who had recovered from an episode of HE during the previous month were assigned randomly ( using computer-generated allocation ) to groups given a probiotic preparation ( VSL # 3 , 9 10 ( 11 ) bacteria ; CD Pharma India Private Limited , New Delhi , India ) ( n = 66 ) or placebo ( n = 64 ) daily for 6 months .
RESULTS	There was a trend toward a reduction in the development of breakthrough HE among patients receiving the probiotic ( 34.8 % in the probiotic group vs 51.6 % in the placebo group ; hazard ratio [ HR ] , 0.65 ; 95 % confidence interval [ CI ] , 0.38-1 .11 ; P = .12 ) .
RESULTS	Fewer patients in the probiotic group were hospitalized for HE ( 19.7 % vs 42.2 % , respectively ; HR , 0.45 ; 95 % CI , 0.23-0 .87 ; P = .02 ) or for complications of cirrhosis ( 24.2 % ) than in the placebo group ( 45.3 % ) ( HR , 0.52 ; 95 % CI , 0.28-0 .95 ; P = .034 ) .
RESULTS	Child-Turcotte-Pugh and model for end-stage liver disease scores improved significantly from baseline to 6 months in the probiotic group , but not in the placebo group .
RESULTS	There were no adverse events related to VSL # 3 .
CONCLUSIONS	Over a 6-month period , daily intake of VSL # 3 significantly reduced the risk of hospitalization for HE , as well as Child-Turcotte-Pugh and model for end-stage liver disease scores , in patients with cirrhosis .
CONCLUSIONS	ClinicalTrials.gov number : NCT01110447 .

###25711125
BACKGROUND	There are limited data to inform the choice between parental presence at clinical bedside rounds ( PPCBR ) and non-PPCBR in neonatal intensive care units ( NICUs ) .
METHODS	We performed a single-centre , survey-based , crossed-over randomised trial involving parents of all infants who were admitted to NICU and anticipated to stay > 11 days .
METHODS	Parents were randomly assigned using a computer-generated stratified block randomisation protocol to start with PPCBR or non-PPCBR and then crossed over to the other arm after a wash-out period .
METHODS	At the conclusion of each arm , parents completed the ` NICU Parental Stressor Scale ' ( a validated tool ) and a satisfaction survey .
METHODS	After completion of the trial , we surveyed all healthcare providers who participated at least in one PPCBR rounding episode .
METHODS	We also offered all participating parents and healthcare providers the opportunity to partake in a focus group discussion regarding PPCBR .
RESULTS	A total of 72 parents were enrolled in this study , with 63 parents ( 87 % ) partially or fully completing the trial .
RESULTS	Of the parents who completed the trial , 95 % agreed that parents should be allowed to attend clinical bedside rounds .
RESULTS	A total of 39 healthcare providers ' surveys were returned and 35 ( 90 % ) agreed that parents should be allowed to attend rounds .
RESULTS	Nine healthcare providers and 8 parents participated in an interview or focus group , augmenting our understanding of the ways in which PPCBR was beneficial .
CONCLUSIONS	Parents and healthcare providers strongly support PPCBR .
CONCLUSIONS	NICUs should develop policies allowing PPCBR while mitigating the downsides and concerns of parents and healthcare providers such as decreased education opportunity and confidentiality concerns .
BACKGROUND	Australia and New Zealand Clinical Trials Register number , ACTRN12612000506897 .

###25195020
BACKGROUND	Depression is not a normal side effect of aging , however it is one of the most prevalent mental health issues in later life , imposing a tremendous burden on patients , their families , and the healthcare system .
BACKGROUND	We describe the experimental implementation of a collaborative , stepped-care model for the treatment of late-life depression ( GermanIMPACT trial ) in the German primary care context .
BACKGROUND	GermanIMPACT was developed as an adaptation of a successful and widely used American model .
BACKGROUND	The aim of the study is to evaluate the model 's applicability to the German primary care setting and its cost-effectiveness .
METHODS	The study will be conducted as a cluster-randomized controlled trial comparing the development of depressive symptoms in primary care patients who either receive treatment as usual ( control arm ) or treatment according to the GermanIMPACT model ( intervention arm ) .
METHODS	In two German cities ( Freiburg and Hamburg ) , a total of 60 general practice offices will be selected and randomized .
METHODS	Each general practice office will be asked to enroll five patients into the trial who are 60 years of age or older and who show moderate depressive symptoms in the scope of a diagnosed depressive episode , recurrent depressive disorder , or dysthymia .
METHODS	General practices in the control arm will provide treatment as usual ; general practices in the intervention arm will work closely with a specially trained care manager and a supervising mental health specialist .
METHODS	Evidence-based elements of the treatment plan manual include patient education , identification and integration of positive activities into the daily routine , relapse prevention , and training of problem-solving techniques as needed .
METHODS	The intervention period per patient will be one year .
METHODS	Data will be collected at baseline , 6 , and 12 months .
METHODS	Primary outcome is the patient-reported change of depressive symptoms ( Patient Health Questionnaire , PHQ-9 ) .
METHODS	Secondary outcomes include measures of quality of life , anxiety , depression-related behavior , problem-solving skills , resilience , and an overall economic evaluation of the program .
CONCLUSIONS	The GermanIMPACT trial will provide evidence about the effectiveness , feasibility , and cost-effectiveness of collaborative stepped care in treating late-life depression in German primary care .
CONCLUSIONS	Positive results will be a first step toward integrating specialized depression care managers into the primary care setting .
BACKGROUND	German Clinical Trials Register : DRKS00003589 ( September 2012 ) .

###24594833
BACKGROUND	Probiotic supplementation significantly reduces the risk of necrotising enterocolitis ( NEC ) and all cause mortality in preterm neonates .
BACKGROUND	Independent quality assessment is important before introducing routine probiotic supplementation in this cohort .
OBJECTIVE	To assess product quality , and confirm that Bifidobacterium breve ( B. breve ) M-16V supplementation will increase fecal B. breve counts without adverse effects .
METHODS	Strain identity ( 16S rRNA gene sequencing ) , viability over 2 year shelf-life were confirmed , and microbial contamination of the product was ruled out .
METHODS	In a controlled trial preterm neonates ( Gestation < 33 weeks ) ready to commence or on feeds for < 12 hours were randomly allocated to either B. breve M-16V ( 3109 cfu/day ) or placebo ( dextrin ) supplementation until the corrected age 37 weeks .
METHODS	Stool samples were collected before ( S1 ) and after 3 weeks of supplementation ( S2 ) for studying fecal B. breve levels using quantitative PCR ( Primary outcome ) .
METHODS	Secondary outcomes included total fecal bifidobacteria and NECStage II .
METHODS	Categorical and continuous outcomes were analysed using Chi-square and Mann-Whitney tests , and McNemar and Wilcoxon signed-rank tests for paired comparisons .
RESULTS	A total of 159 neonates ( Probiotic : 79 , Placebo : 80 ) were enrolled .
RESULTS	Maternal and neonatal demographic characteristics were comparable between the groups .
RESULTS	The proportion of neonates with detectable B. breve increased significantly post intervention : Placebo : [ S1 :2 / 66 ( 3 % ) , S2 : 25/66 ( 38 % ) , p < 0.001 ] Probiotic : [ S1 : 29/74 ( 40 % ) , S2 : 67/74 ( 91 % ) , p < 0.001 ] .
RESULTS	Median S1 B. breve counts in both groups were below detection ( < 4.7 log cells x g ( -1 ) ) , increasing significantly in S2 for the probiotic group ( log 8.6 ) while remaining < 4.7 log in the control group ( p < 0.001 ) .
RESULTS	There were no adverse effects including probiotic sepsis and no deaths .
RESULTS	NECStage II occurred in only 1 neonate ( placebo group ) .
CONCLUSIONS	B. breve M-16V is a suitable probiotic strain for routine use in preterm neonates .
BACKGROUND	Australia New Zealand Clinical Trial Registry ACTRN 12609000374268 .

###25211291
OBJECTIVE	To investigate the effect of manual physiotherapy and exercises compared with exercises alone in patients with shoulder impingement syndrome one year after inclusion .
METHODS	Randomized controlled trial .
METHODS	Patients with shoulder impingement of more than 4 weeks .
METHODS	The intervention group received individualized manual physiotherapy plus individualized exercises ; the control group received individualized exercises only .
METHODS	Both groups had 10 treatments over 5 weeks ; afterwards all patients continued their exercises for another 7 weeks at home .
METHODS	Primary outcomes were the Shoulder Pain and Disability Index and Patients ' Global Impression of Change .
METHODS	The Generic Patient-Specific Scale was used as secondary outcome .
METHODS	Costs were recorded in a log-book .
RESULTS	Ninety patients were included in the study and 87 could be analyzed at 1-year follow-up .
RESULTS	Both groups showed significant improvements in all outcome measures , but no difference was detected between the groups .
RESULTS	Only costs differed significantly in favour of the control group ( p = 0.03 ) after 5 weeks .
CONCLUSIONS	Individualized exercises resulted in lower costs than manual physiotherapy and showed a significant effect on pain and functioning within the whole group after one year .
CONCLUSIONS	Exercises should therefore be considered as a basic treatment .
CONCLUSIONS	Due to the progressive improvement that occurred during the follow-up period with individualized exercises further treatments should be delayed for 3 to 4 months .

###24877997
BACKGROUND	Dengue infection is the most common mosquito-borne viral disease worldwide , but no suitable antiviral drugs are available .
BACKGROUND	We tested the - glucosidase inhibitor celgosivir as a treatment for acute dengue fever .
METHODS	To establish eligibility for inclusion in a phase 1b , randomised , double-blind , placebo-controlled , proof-of-concept trial , individuals aged 21-65 years who had had a fever ( 38C ) for less than 48 h , met at least two criteria indicating probable dengue infection , and had a positive result on a dengue point-of-care test kit or PCR assay were referred for screening at a centre in Singapore between July 30 , 2012 , and March 4 , 2013 .
METHODS	Using a web-based system , we randomly assigned patients who met full inclusion criteria after screening ( 1:1 ; random permuted block length four ) to celgosivir ( initial 400 mg loading dose within 6 h of randomisation , followed by 200 mg every 12 h for a total of nine doses ) or matched placebo .
METHODS	Patients and the entire study team were masked to group assignment .
METHODS	The primary endpoints were mean virological log reduction ( VLR ) from baseline for days 2 , 3 , and 4 , and area under the fever curve ( AUC ) for a temperature above 37C from 0 h to 96 h. Efficacy analyses were by intention to treat .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01619969 .
RESULTS	We screened 69 patients and randomly assigned 50 ( 24 to celgosivir , 26 to placebo ) .
RESULTS	Mean VLR was greater in the celgosivir group ( -186 , SD 107 ) than in the placebo group ( -164 , 075 ) , but the difference was non-significant ( -022 , 90 % CI -065 to 022 ; one-sided p = 0203 ) .
RESULTS	The mean AUC was also higher in the celgosivir group ( 5492 , SD 3104 ) than in the placebo group ( 4072 , 1869 ) , but again the difference was non-significant ( 1420 , 90 % CI 216-2625 ; one-sided p = 0973 ) .
RESULTS	We noted similar incidences of adverse events between groups .
CONCLUSIONS	Although generally safe and well tolerated , celgosivir does not seem to reduce viral load or fever burden in patients with dengue .
BACKGROUND	STOP Dengue Translational Clinical Research .

###24768811
OBJECTIVE	Patients with cirrhosis have reduced exercise tolerance , measured objectively as decreased peak exercise oxygen uptake ( peak VO2 ) .
OBJECTIVE	Reduced peak VO2 is associated with decreased survival time .
OBJECTIVE	The effect of aerobic exercise training on peak VO2 has not been well studied in patients with cirrhosis .
OBJECTIVE	We evaluated the safety and efficacy of 8 weeks of supervised exercise on peak VO2 , quadriceps muscle thickness , and quality of life .
METHODS	In a prospective pilot study , stable patients ( 79 % male , 57.6 6.7 years old ) with Child-Pugh class A or B cirrhosis ( mean Model for End-Stage Liver Disease score , 10 2.2 ) were randomly assigned to groups that received exercise training ( n = 9 ) or usual care ( controls , n = 10 ) at the University of Alberta Hospital in Canada from February through June 2013 .
METHODS	Supervised exercise was performed on a cycle ergometer 3 days/week for 8 weeks at 60 % -80 % of baseline peak VO2 .
METHODS	Peak VO2 , quadriceps muscle thickness ( measured by ultrasound ) , thigh circumference , answers from Chronic Liver Disease Questionnaires , EQ-visual analogue scales , 6-minute walk distance , and Model for End-Stage Liver Disease scores were evaluated at baseline and at week 8 .
METHODS	Analysis of covariance was used to compare variables .
RESULTS	At week 8 , peak VO2 was 5.3 mL/kg/min higher in the exercise group compared with controls ( 95 % confidence interval , 2.9-7 .8 ; P = .001 ) .
RESULTS	Thigh circumference ( P = .001 ) , thigh muscle thickness ( P = .01 ) , and EQ-visual analogue scale determined self-perceived health status ( P = .01 ) was also significantly higher in the exercise group compared with controls at week 8 ; fatigue subscores of the Chronic Liver Disease Questionnaires were lower in the exercise group compared with controls ( P = .01 ) .
RESULTS	No adverse events occurred during cardiopulmonary exercise testing or training .
CONCLUSIONS	In a controlled prospective pilot trial , 8 weeks of supervised aerobic exercise training increased peak VO2 and muscle mass and reduced fatigue in patients with cirrhosis .
CONCLUSIONS	No relevant adverse effects were observed .
CONCLUSIONS	Larger trials are needed to evaluate the effects of exercise in patients with cirrhosis .
CONCLUSIONS	ClinicalTrials.gov number : NCT01799785 .

###24579935
OBJECTIVE	Guidelines consider certain probiotics useful in the management of acute gastroenteritis .
OBJECTIVE	This study evaluated the use of Lactobacillus ( L ) reuteri DSM 17938 .
METHODS	A multicentre , randomised , single-blind clinical trial was performed in hospitalised children with acute gastroenteritis lasting 12-72 h. Children received conventional therapy with , or without , 1 10 ( 8 ) CFU of L. reuteri DSM 17938 for 5 days .
METHODS	The primary endpoint was the duration of diarrhoea and secondary outcomes were days of hospitalisation and the percentage of children with diarrhoea after each day of treatment .
RESULTS	We compared 64 children receiving L. reuteri with 63 controls .
RESULTS	Lactobacillus reuteri reduced the duration of diarrhoea after 24 h ( p < 0.001 ) and more diarrhoea-free children were seen in the L. reuteri than control group after 24 and 48 h ( 50 % versus 5 % , p < 0.001 ) and 72 h ( 69 % versus 11 % , p < 0.001 ) .
RESULTS	Lactobacillus reuteri reduced mean hospital stays ( 4.31 1.3 days versus 5.46 1.77 days , p < 0.001 ) .
RESULTS	Prolonged diarrhoea occurred in 17 % of the controls , but none of the L. reuteri group .
RESULTS	No adverse effects were reported .
CONCLUSIONS	Lactobacillus reuteri effectively reduced the duration of acute diarrhoea and hospital stays in children hospitalised with acute gastroenteritis .
CONCLUSIONS	Outpatient data are now required .

###25007676
OBJECTIVE	To compare postoperative voice recovery time of vocal polyps treated with different power levels of CO2 laser and conventional laryngeal microsurgery on vocal polyps .
METHODS	Two hundred patients with vocal polyps were randomly divided into four groups , which were respectively treated with conventional laryngeal microsurgery and different power levels of CO2 laser ( 2 W , 4 W and 6 W ) under laryngoscope .
METHODS	The postoperative voice recovery time were analyzed .
RESULTS	All vocal polyps were resected at one time without any serious complications like dyspnea or bleeding .
RESULTS	The postoperative voice recovery time were 7.2 days for the group of patients received conventional laryngeal microsurgery and 7.6 days for the group of patients treated with 2 W CO2 laser , which were hoch significantly different from that in the group of patients treated with 6 W CO2 laser ( P < 0.05 ) .
CONCLUSIONS	The postoperative recovery time of patients treated with conventional laryngeal microsurgery and small power of CO2 laser is shorter than those operated with the other larger power of CO2 laser .

###24390009
OBJECTIVE	Low-intensity pulsed ultrasound ( LIPUS ) has been used successfully to accelerate healing of fresh fractures and non-unions .
OBJECTIVE	It also improved callus maturation with distraction osteogenesis in animal trials .
OBJECTIVE	However , only few clinical studies are available to support its widespread use for the latter indication in humans .
METHODS	Twenty-one patients undergoing callus distraction for posttraumatic tibial defects were randomized into two groups : the trial group ( 12 men ; mean age 32 years ) which received 20 minutes LIPUS daily during treatment and the control group ( six men and three women ; mean age 29 years ) without LIPUS treatment .
METHODS	The Ilizarov ring fixator was used in all cases .
METHODS	Results were examined clinically and radiologically , analysing callus maturation with a computer-assisted measurement .
RESULTS	Patients in the LIPUS group needed a mean of 33 days to consolidate every 1 cm of new bone in comparison to 45 days in the control group .
RESULTS	The healing index was therefore shortened by 12 days/cm in the LIPUS group .
RESULTS	This means that callus maturation was 27 % faster in the LIPUS group .
RESULTS	The fixator time was shortened by 95 days in the LIPUS group .
RESULTS	The overall daily increase in radiographic callus density was 33 % more in the LIPUS group than in the control group .
CONCLUSIONS	LIPUS treatment is an effective non-invasive adjuvant method to enhance callus maturation in distraction osteogenesis .
CONCLUSIONS	With the help of this treatment , the healing time and the duration of external fixation can be reliably shortened .

###24756913
BACKGROUND	Anatomical suitability for arteriovenous fistula ( AVF ) formation was formerly determined by clinical examination alone .
BACKGROUND	There are potential benefits from imaging to assess anatomical suitability .
BACKGROUND	Existing studies examined the role of routine preoperative ultrasonography versus clinical examination alone .
BACKGROUND	The role of a selective duplex ultrasound imaging policy is unknown .
BACKGROUND	This study aimed to compare a policy of selective versus routine ultrasound assessment before AVF formation .
METHODS	All patients referred for fistula formation were assessed for inclusion .
METHODS	Suitable patients were randomized to either routine or selective preoperative ultrasound imaging ; selective imaging was performed only when clinical criteria were not met .
METHODS	The primary outcome measures were site of AVF formation and 30-day primary failure rate , and secondary outcome measures included the rate of complications .
RESULTS	A total of 106 patients were assessed , and 94 were randomized : 47 to selective and 47 to routine duplex ultrasonography .
RESULTS	The groups were well matched for age , co-morbidities and medications .
RESULTS	The primary failure rate ( 29 per cent overall ) was not significantly different between the selective and routine imaging groups : 36 per cent ( 14 of 39 ) and 21 per cent ( 8 of 38 ) respectively ( P = 0144 ) .
RESULTS	There were no significant differences in the sites of AVF formation or complication rates .
CONCLUSIONS	Routine preoperative ultrasound vessel imaging did not significantly reduce early failure rates , influence the site of AVF formation or reduce complications .
CONCLUSIONS	If clinical evaluation detects anatomy suitable for AVF formation , duplex imaging may not be needed .
BACKGROUND	NCT01004627 ( http://www.clinicaltrials.gov ) .

###24238397
BACKGROUND	Medication adherence is critical for patient treatment .
BACKGROUND	This study involved evaluating how implementing Short Message Service ( SMS ) reminders affected patient medication adherence and related factors .
METHODS	We used a structured questionnaire to survey outpatients at three medical centers .
METHODS	Patients aged 20 years and older who were prescribed more than 7 days of a prescription medication were randomized into SMS intervention or control groups .
METHODS	The intervention group received daily messages reminding them of aspects regarding taking their medication ; the control group received no messages .
METHODS	A phone follow-up was performed to assess outcomes after 8 days .
METHODS	Data were collected from 763 participants in the intervention group and 435 participants in the control group .
RESULTS	After participants in the intervention group received SMS reminders to take medication or those in the control group received no messages , incidences of delayed doses were decreased by 46.4 and 78.8 % for those in the control and intervention groups , respectively .
RESULTS	The rate of missed doses was decreased by 90.1 % for participants in the intervention group and 61.1 % for those in the control group .
RESULTS	We applied logistic regression analysis and determined that participants in the intervention group had a 3.2-fold higher probability of having a decrease in delayed doses compared with participants in the control group .
RESULTS	Participants in the intervention group also showed a 2.2-fold higher probability of having a decrease in missed doses compared with participants in the control group .
CONCLUSIONS	Use of SMS significantly affected the rates of taking medicine on schedule .
CONCLUSIONS	Therefore , daily SMS could be useful for reminding patients to take their medicine on schedule .

###24802974
OBJECTIVE	Olfactory loss impairs the patient 's quality of life .
OBJECTIVE	In individualized therapies , olfactory drug effects gain clinical importance .
OBJECTIVE	Molecular evidence suggests that among drugs with potential olfactory effects is ( 9 ) - tetrahydrocannabinol ( THC ) , which is approved for several indications , including neuropathic pain or analgesia in cancer patients .
OBJECTIVE	The present study aimed at assessing the olfactory effects of THC to be expected during analgesic treatment .
METHODS	The effects of 20mg oral THC on olfaction were assessed in a placebo-controlled , randomized cross-over study in healthy volunteers .
METHODS	Using an established olfactory test ( Sniffin ' Sticks ) , olfactory thresholds , odour discrimination and odour identification were assessed in 15 subjects at baseline and 2h after THC administration .
RESULTS	( 9 ) - Tetrahydrocannabinol impaired the performance of subjects ( n = 15 ) in the olfactory test .
RESULTS	Specifically , olfactory thresholds were increased and odour discrimination performance was reduced .
RESULTS	This resulted in a significant drop in composite threshold , discrimination , identification ( TDI ) olfactory score by 5.5 points ( from 37.7 4.2 to 32.2 5.6 , 95 % confidence interval for differences THCvs .
RESULTS	placebo , -7.8 to -2.0 , P = 0.003 ) , which is known to be a subjectively perceptible impairment of olfactory function .
CONCLUSIONS	Considering the resurgence of THC in medical use for several pathological conditions , the present results indicate that THC-based analgesics may be accompanied by subjectively noticeable reductions in olfactory acuity .
CONCLUSIONS	In particular , for patients relying on their sense of smell , this might be relevant information for personalized therapy strategies .

###24398718
OBJECTIVE	The purpose of this study was to examine the feasibility of core stabilization exercise with real-time feedback on balance and gait function in patients with chronic hemiparetic stroke .
METHODS	Nineteen stroke subjects were enrolled in this study .
METHODS	The patients were randomly divided into the experimental ( n = 10 ) and control groups ( n = 9 ) .
METHODS	Subjects in the experimental group performed core stabilization exercise with real-time feedback training for 30 minutes per day during a period of six weeks .
METHODS	Subjects in the control group performed core stabilization exercise during the same period .
METHODS	This study assessed the kinematic parameters using a portable walkway system , and timed up-and-go test .
RESULTS	Gait velocity showed significantly greater improvement in the experimental group ( 7.3 5.0 sec ) than in the control group ( -0.7 10.6 ) .
RESULTS	Stride length showed significantly greater increase in the experimental group ( 13.2 7.9 on the affected side and 12.6 8.0 on the less affected side ) than the control group ( 3.5 8.7 on the affected side and 3.4 8.5 on the less affected side ) .
RESULTS	After training , change in results on the timed up and go test was significantly greater in the experimental group than in the control group .
CONCLUSIONS	Core stabilization exercise using real-time feedback produces greater improvement in gait performance in chronic hemiparetic stroke patients than core stabilization exercise only .

###26100611
BACKGROUND	Interparental violence is both common and harmful and impacts children 's lives directly and indirectly .
BACKGROUND	Direct effects refer to affective , behavioral , and cognitive responses to interparental violence and psychosocial adjustment .
BACKGROUND	Indirect effects refer to deteriorated parental availability and parent-child interaction .
BACKGROUND	Standard Trauma Focused Cognitive Behavioral Therapy may be insufficient for children traumatized by exposure to interparental violence , given the pervasive impact of interparental violence on the family system .
BACKGROUND	HORIZON is a trauma focused cognitive behavioral therapy based group program with the added component of a preparatory parenting program aimed at improving parental availability ; and the added component of parent-child sessions to improve parent-child interaction .
METHODS	This is a multicenter , multi-informant and multi-method randomized clinical trial study with a 2 by 2 factorial experimental design .
METHODS	Participants ( N = 100 ) are children ( 4-12 years ) , and their parents , who have been exposed to interparental violence .
METHODS	The main aim of the study is to test the effects of two parental components as an addition to a trauma focused cognitive behavioral based group therapy for reducing children 's symptoms .
METHODS	Primary outcome measures are posttraumatic stress symptoms , and internalizing and externalizing problems in children .
METHODS	The secondary aim of the study is to test the effect of the two added components on adjustment problems in children and to test whether enhanced effects can be explained by changes in children 's responses towards experienced violence , in parental availability , and in quality of parent-child interaction .
METHODS	To address this secondary aim , the main parameters are observational and questionnaire measures of parental availability , parent-child relationship variables , children 's adjustment problems and children 's responses to interparental violence .
METHODS	Data are collected three times : before and after the program and six months later .
METHODS	Both intention-to-treat and completer analyses will be done .
CONCLUSIONS	The current study will enhance our understanding of the efficacy interparental violence-related parental components added to trauma focused cognitive behavioral group program for children who have been exposed to IPV .
CONCLUSIONS	It will illuminate mechanisms underlying change by considering multiple dimensions of child responses , parenting variables and identify selection criteria for participation in treatment .
BACKGROUND	Netherlands Trial Register NTR4015 .
BACKGROUND	Registered 4th of June , 2013 .

###24447063
OBJECTIVE	The epilepsy treatment gap is largest in resource-poor countries .
OBJECTIVE	We evaluated the efficacy of a 1-day health education program in a rural area of Kenya .
OBJECTIVE	The primary outcome was adherence to antiepileptic drugs ( AEDs ) as measured by drug levels in the blood , and the secondary outcomes were seizure frequency and Kilifi Epilepsy Beliefs and Attitudes Scores ( KEBAS ) .
METHODS	Seven hundred thirty-eight people with epilepsy ( PWE ) and their designated supporter were randomized to either the intervention ( education ) or nonintervention group .
METHODS	Data were collected at baseline and 1year after the education intervention was administered to the intervention group .
METHODS	There were 581 PWE assessed at both time points .
METHODS	At the end of the study , 105 PWE from the intervention group and 86 from the nonintervention group gave blood samples , which were assayed for the most commonly used AEDs ( phenobarbital , phenytoin , and carbamazepine ) .
METHODS	The proportions of PWE with detectable AED levels were determined using a standard blood assay method .
METHODS	The laboratory technicians conducting the assays were blinded to the randomization .
METHODS	Secondary outcomes were evaluated using questionnaires administered by trained field staff .
METHODS	Modified Poisson regression was used to investigate the factors associated with improved adherence ( transition from nonoptimal AED level in blood at baseline to optimal levels at follow-up ) , reduced seizures , and improved KEBAS , which was done as a post hoc analysis .
METHODS	This trial is registered in ISRCTN register under ISRCTN35680481 .
RESULTS	There was no significant difference in adherence to AEDs based on detectable drug levels ( odds ratio [ OR ] 1.46 , 95 % confidence interval [ 95 % CI ] 0.74-2 .90 , p = 0.28 ) or by self-reports ( OR 1.00 , 95 % CI 0.71-1 .40 , p = 1.00 ) between the intervention and nonintervention group .
RESULTS	The intervention group had significantly fewer beliefs about traditional causes of epilepsy , cultural treatment , and negative stereotypes than the nonintervention group .
RESULTS	There was no difference in seizure frequency .
RESULTS	A comparison of the baseline and follow-up data showed a significant increase in adherence-intervention group ( 36-81 % [ p < 0.001 ] ) and nonintervention group ( 38-74 % [ p < 0.001 ] ) - using detectable blood levels .
RESULTS	The number of patients with less frequent seizures ( 3 seizures in the last 3months ) increased in the intervention group ( 62-80 % [ p = 0.002 ] ) and in the nonintervention group ( 67-75 % [ p = 0.04 ] ) .
RESULTS	Improved therapeutic adherence ( observed in both groups combined ) was positively associated with positive change in beliefs about risks of epilepsy ( relative risk [ RR ] 2.00 , 95 % CI 1.03-3 .95 ) and having nontraditional religious beliefs ( RR 2.01 , 95 % CI 1.01-3 .99 ) .
RESULTS	Reduced seizure frequency was associated with improved adherence ( RR 1.72 , 95 % CI 1.19-2 .47 ) .
RESULTS	Positive changes in KEBAS were associated with having tertiary education as compared to none ( RR 1.09 , 95 % CI 1.05-1 .14 ) .
CONCLUSIONS	Health education improves knowledge about epilepsy , but once only contact does not improve adherence .
CONCLUSIONS	However , sustained education may improve adherence in future studies .

###24354588
BACKGROUND	Vaccine effectiveness is usually determined in randomized controlled trials ( RCT ) and if effective , additional information , e.g. on cost-effectiveness , is required to allow evidence-based decision making .
BACKGROUND	A prerequisite for proper health economic modelling is the availability of good quality data on health care resources use , health outcomes and quality-of-life ( QoL ) data .
BACKGROUND	The `` Collecting health outcomes and economic data on hospitalized Community Acquired Pneumonia ( CHO-CAP ) -- a prospective cohort study '' is executed alongside the Community Acquired Pneumonia Immunization Trial with Adults ( CAPiTA trial ) to capture health outcomes and economic data of elderly hospitalized with CAP and matched controls without CAP .
METHODS	CAPiTA is a placebo-controlled double-blind RCT evaluating the effectiveness of a 13-valent conjugated pneumococcal vaccine in preventing vaccine-type pneumococcal CAP in 84,496 elderly in the Netherlands .
METHODS	Participants of CAPiTA , who consented and provided information on health status ( EQ-5D ) and socio-demographic background at the time of vaccination , constitute the source population of CHO-CAP and are eligible for the nested matched cohort study .
METHODS	CHO-CAP patients hospitalized with CAP form the `` diseased '' cohort and the `` non-diseased '' cohort consists of unaffected persons ( i.e. no CAP ) .
METHODS	Observations in the diseased cohort and in matched controls from the non-diseased cohort are used to determine excess costs and QoL changes attributable to CAP.Based on an estimated 2,000 CAPiTA participants being hospitalized with CAP and an assumed CHO-CAP participation rate of 30 % of all CAPiTA participants ( 25,000 ) , 600 CAP episodes are expected among CHO-CAP participants ( the `` diseased '' cohort ) .
METHODS	For each patient with CAP , two non-diseased CHO-CAP subjects will be selected from the CHO-CAP cohort , with matching for age , gender and EQ-5D baseline-score .
METHODS	Data on healthcare and non-healthcare resources use , quality-of-life ( using EQ-5D and SF-36 questionnaires ) and selected health outcomes will be collected at 0 , 1 , 6 and 12 months after hospitalization for CAP.The CHO-CAP study was approved by the Central Committee on Research involving Human Subjects in the Netherlands .
CONCLUSIONS	With an expected 600 CAP episodes this study will be one of the biggest prospectively studied cohorts of hospitalized elderly with CAP with regard to resources use and Qol data .
CONCLUSIONS	Strengths of this study further include collection of out-of-pocket costs of patients and productivity losses of both patients and their caregivers and the follow-up period of up to one year post-discharge .
CONCLUSIONS	This study is therefore expected to add more in-depth knowledge on the short and longer term outcomes of pneumonia in elderly .
BACKGROUND	ClinicalTrials.gov , NCT00812084 .

###25399273
OBJECTIVE	The role of vascular closure devices ( VCD ) for the achievement of hemostasis in patients undergoing transfemoral coronary angiography remains controversial .
OBJECTIVE	To compare outcomes with the use of 2 hemostasis strategies after diagnostic coronary angiography performed via transfemoral access-a VCD-based strategy with 2 types of devices , an intravascular device and an extravascular device , vs standard manual compression .
OBJECTIVE	The primary hypothesis to be tested was that femoral hemostasis achieved through VCD is noninferior to manual compression in terms of vascular access-site complications .
OBJECTIVE	A secondary objective was the comparison of the 2 types of VCD .
METHODS	Randomized , large-scale , multicenter , open-label clinical trial .
METHODS	We enrolled 4524 patients undergoing coronary angiography with a 6 French sheath via the common femoral artery from April 2011 through May 2014 in 4 centers in Germany .
METHODS	Last 30-day follow-up was performed in July 2014 .
METHODS	After angiography of the access site , patients were randomized to hemostasis with an intravascular VCD , extravascular VCD , or manual compression in a 1:1:1 ratio .
METHODS	Primary end point : the composite of access site-related vascular complications at 30 days after randomization with a 2 % noninferiority margin .
METHODS	Secondary end points : time to hemostasis , repeat manual compression , and VCD failure .
METHODS	An - level of .025 was chosen for primary and secondary comparisons .
RESULTS	Of the 4524 enrolled patients , 3015 were randomly assigned to a VCD group ( 1509 received intravascular VCD and 1506 received extravascular VCD ) and 1509 patients were randomly assigned to the manual compression group .
RESULTS	Before hospital discharge , duplex sonography of the access site was performed in 4231 ( 94 % ) patients .
RESULTS	The primary end point was observed in 208 patients ( 6.9 % ) assigned to receive a VCD and 119 patients ( 7.9 % ) assigned to manual compression ( difference , -1.0 % [ 1-sided 97.5 % CI , 0.7 % ] ; P for noninferiority < .001 ) .
RESULTS	Time to hemostasis was significantly shorter in patients with VCD ( 1 minute [ interquartile range { IQR } , 0.5-2 .0 ] ) , vs manual compression ( 10 minutes [ IQR , 10-15 ] ; P < .001 ) .
RESULTS	Time to hemostasis was significantly shorter among patients with intravascular VCD ( 0.5 minute [ IQR , 0.2-1 .0 ] ) , vs extravascular VCD ( 2.0 minutes [ IQR , 1.0-2 .0 ] ; P < .001 ) and closure device failure was also significantly lower among those with intravascular vs extravascular VCD ( 80 patients [ 5.3 % ] , vs 184 patients [ 12.2 % ] ; P < .001 ) .
CONCLUSIONS	In patients undergoing transfemoral coronary angiography , VCDs were noninferior to manual compression in terms of vascular access-site complications and reduced time to hemostasis .
BACKGROUND	clinicaltrials.gov Identifier : NCT01389375 .

###25525195
OBJECTIVE	Maximizing ART efficiency is of growing interest .
OBJECTIVE	This study assessed the efficacy , safety , pharmacokinetics and economics of a darunavir dose-reduction strategy .
METHODS	This was a multicentre , randomized , open-label clinical trial in HIV-infected patients with plasma HIV-1 RNA < 50 copies/mL while receiving triple ART including 800 mg of darunavir once daily .
METHODS	Participants were randomized to continue 800 mg of darunavir ( DRV800 ) or to 600 mg of darunavir ( DRV600 ) , both once daily .
METHODS	Treatment failure was defined as two consecutive HIV-1 RNA determinations > 50 copies/mL or discontinuation of study treatment by week 48 .
METHODS	The study was registered at https://www.clinicaltrialsregister.eu ( trial number 2011-006272-39 ) .
RESULTS	Fifty participants were allocated to each arm .
RESULTS	The mean ( SD ) CD4 + T cell count at baseline was 562 ( 303 ) cells/mm ( 3 ) and HIV-1 RNA had been < 50 copies/mL for a median ( IQR ) of 106.9 ( 43.4-227 .9 ) weeks before enrolment .
RESULTS	At week 48 no treatment failure had occurred in 45/50 ( 90 % ) DRV600 patients and in 47/50 ( 94 % ) DRV800 patients ( difference -4 % ; 95 % CI lower limit , -12.9 % ) .
RESULTS	When only patients with virological data were considered , that endpoint was met by 45/48 ( 94 % ) in the DRV600 arm and 47/49 ( 96 % ) in the DRV800 arm ( difference -2.2 % ; 95 % CI lower limit , -9.6 % ) .
RESULTS	Darunavir exposure was similar in the two arms .
RESULTS	The average reduction in annual cost per successfully treated DRV600-arm patient was US$ 7273 .
CONCLUSIONS	The efficacy of a darunavir daily dose of 600 mg seemed to be similar to the efficacy of the standard 800 mg dose in virologically suppressed HIV-infected patients on triple ART .
CONCLUSIONS	This strategy can potentially translate to substantial savings in the cost of care of HIV-infected patients .

###25315167
BACKGROUND	The postpartum period can be a challenging time particularly for first-time mothers .
BACKGROUND	This study aimed to assess two different interventions designed to reduce stress in the postpartum among first-time mothers .
METHODS	Healthy first-time mothers with healthy newborns were recruited from hospitals in Beirut , Lebanon after delivery .
METHODS	The two interventions were a 20-minute film addressing common stressors in the postpartum period and a 24-hour telephone support hotline .
METHODS	Participants were randomized to one of four study arms to receive either the postpartum support film , the hotline service , both interventions , or a music CD ( control ) .
METHODS	Participants were interviewed at eight to twelve weeks postpartum for assessment of levels of stress as measured by the Cohen Perceived Stress Scale ( PSS-10 ) .
RESULTS	Of the 632 eligible women , 552 ( 88 % ) agreed to participate in the study .
RESULTS	Of those , 452 ( 82 % ) completed the study .
RESULTS	Mean PSS-10 scores of mothers who received the film alone ( 15.76 ) or the film with the hotline service ( 15.86 ) were significantly lower than that of the control group ( 18.93 ) ( p-value < 0.01 ) .
RESULTS	Among mothers who received the hotline service alone mean PSS-10 score ( 16.98 ) was also significantly lower than that of the control group ( p-value < 0.05 ) .
CONCLUSIONS	Both our postpartum support film and the 24-hour telephone hotline service reduced stress in the postpartum period in first-time mothers .
CONCLUSIONS	These simple interventions can be easily implemented and could have an important impact on the mental wellbeing of new mothers .
BACKGROUND	The trial was registered with clinicaltrials.gov ( identifier # NCT00857051 ) on March 5 , 2009 .

###25204507
OBJECTIVE	To examine whether dexmedetomidine reduces the injection pain of propofol and rocuronium and to investigate whether the decrease in injection pain is associated with the known sedative action of dexmedetomidine .
METHODS	Randomized , double-blind , placebo-controlled clinical comparison study .
METHODS	Patients undergoing general anesthesia with intubation received 40 mg of 1 % lidocaine ( lidocaine group ; n = 28 ) , 0.25 g/kg of dexmedetomidine ( low-dose group ; n = 27 ) , 0.5 g/kg of dexmedetomidine ( subclinical dose group ; n = 28 ) , 1.0 g/kg of dexmedetomidine ( clinical dose group , n = 27 ) , or normal saline ( saline group ; n = 28 ) before anesthetic induction .
METHODS	Pain associated with propofol and rocuronium injection was assessed using a 10-point verbal analog scale ( VAS ) and a 4-point withdrawal movement scale , respectively .
METHODS	The BIS value was measured 60 seconds after administration of the study drug , and at the time of rocuronium injection and intubation .
RESULTS	The overall incidence of withdrawal movements due to rocuronium decreased significantly as the dose of dexmedetomidine increased ( 92.8 % , 85.2 % , 78.6 % , and 51.9 % in the saline , low-dose , subclinical dose , and clinical dose groups , respectively ; P = 0.001 ) .
RESULTS	There was no significant difference in BIS values among the groups 60 seconds after study drug administration or at the time of rocuronium injection .
CONCLUSIONS	Dexmedetomidine reduced pain associated with rocuronium injection in a dose-dependent manner .
CONCLUSIONS	This effect was not associated with the decrease in BIS value .

###25258143
BACKGROUND	Eosinophilic esophagitis ( EoE ) is a chronic antigen-driven allergic inflammatory disease , likely involving the interplay of genetic and environmental factors , yet their respective contributions to heritability are unknown .
OBJECTIVE	To quantify the risk associated with genes and environment on familial clustering of EoE .
METHODS	Family history was obtained from a hospital-based cohort of 914 EoE probands ( n = 2192 first-degree `` Nuclear-Family '' relatives ) and an international registry of monozygotic and dizygotic twins/triplets ( n = 63 EoE `` Twins '' probands ) .
METHODS	Frequencies , recurrence risk ratios ( RRRs ) , heritability , and twin concordance were estimated .
METHODS	Environmental exposures were preliminarily examined .
RESULTS	Analysis of the Nuclear-Family-based cohort revealed that the rate of EoE , in first-degree relatives of a proband , was 1.8 % ( unadjusted ) and 2.3 % ( sex-adjusted ) .
RESULTS	RRRs ranged from 10 to 64 , depending on the family relationship , and were higher in brothers ( 64.0 ; P = .04 ) , fathers ( 42.9 ; P = .004 ) , and males ( 50.7 ; P < .001 ) than in sisters , mothers , and females , respectively .
RESULTS	The risk of EoE for other siblings was 2.4 % .
RESULTS	In the Nuclear-Family cohort , combined gene and common environment heritability was 72.0 % 2.7 % ( P < .001 ) .
RESULTS	In the Twins cohort , genetic heritability was 14.5 % 4.0 % ( P < .001 ) , and common family environment contributed 81.0 % 4 % ( P < .001 ) to phenotypic variance .
RESULTS	Probandwise concordance in monozygotic co-twins was 57.9 % 9.5 % compared with 36.4 % 9.3 % in dizygotic co-twins ( P = .11 ) .
RESULTS	Greater birth weight difference between twins ( P = .01 ) , breast-feeding ( P = .15 ) , and fall birth season ( P = .02 ) were associated with twin discordance in disease status .
CONCLUSIONS	EoE RRRs are increased 10 - to 64-fold compared with the general population .
CONCLUSIONS	EoE in relatives is 1.8 % to 2.4 % , depending on relationship and sex .
CONCLUSIONS	Nuclear-Family heritability appeared to be high ( 72.0 % ) .
CONCLUSIONS	However , the Twins cohort analysis revealed a powerful role for common environment ( 81.0 % ) compared with additive genetic heritability ( 14.5 % ) .

###25413974
BACKGROUND	Serious case reviews and research studies have indicated weaknesses in risk assessments conducted by child protection social workers .
BACKGROUND	Social workers are adept at gathering information but struggle with analysis and assessment of risk .
BACKGROUND	The Department for Education wants to know if the use of a structured decision-making tool can improve child protection assessments of risk .
METHODS	This multi-site , cluster-randomised trial will assess the effectiveness of the Safeguarding Children Assessment and Analysis Framework ( SAAF ) .
METHODS	This structured decision-making tool aims to improve social workers ' assessments of harm , of future risk and parents ' capacity to change .
METHODS	The comparison is management as usual .
METHODS	Children 's Services Departments ( CSDs ) in England willing to make relevant teams available to be randomised , and willing to meet the trial 's training and data collection requirements .
METHODS	CSDs where there were concerns about performance ; where a major organisational restructuring was planned or under way ; or where other risk assessment tools were in use.Six CSDs are participating in this study .
METHODS	Social workers in the experimental arm will receive 2 days training in SAAF together with a range of support materials , and access to limited telephone consultation post-training .
METHODS	The primary outcome is child maltreatment .
METHODS	This will be assessed using data collected nationally on two key performance indicators : the first is the number of children in a year who have been subject to a second Child Protection Plan ( CPP ) ; the second is the number of re-referrals of children because of related concerns about maltreatment .
METHODS	Secondary outcomes are : i ) the quality of assessments judged against a schedule of quality criteria and ii ) the relationship between the three assessments required by the structured decision-making tool ( level of harm , risk of ( re ) abuse and prospects for successful intervention ) .
CONCLUSIONS	This is the first study to examine the effectiveness of SAAF .
CONCLUSIONS	It will contribute to a very limited literature on the contribution that structured decision-making tools can make to improving risk assessment and case planning in child protection and on what is involved in their effective implementation .
BACKGROUND	ISRCTN 45137562 15 July 2014 .

###25367636
OBJECTIVE	This study evaluated the effectiveness of a stress management intervention combining individual cognitive behavioral therapy ( CBT ) with a brief workplace intervention on self-reported measures of sleep and cognitive functioning among patients on sick leave due to work-related stress complaints .
METHODS	Participants were patients referred to the regional Department of Occupational Medicine .
METHODS	Inclusion criteria were ( i ) sick leave due to work-related stress complaints and ( ii ) a diagnosis of adjustment disorder/reactions to stress or mild depression .
METHODS	Participants ( N = 137 ) were randomized to either an intervention ( N = 57 ) or control ( N = 80 ) group .
METHODS	The intervention comprised six sessions with a psychologist and the offer of a small workplace intervention .
METHODS	Questionnaires were answered at baseline and after 4 , and 10 months .
RESULTS	Symptoms were significantly reduced over time in both groups but there was no significant treatment effect on sleep or cognitive outcomes at any time point .
RESULTS	From 0-4 months , there was a tendency for larger improvements in the intervention group with regards to sleep and cognitive failures in distraction .
RESULTS	Although neither was significant , the results came close to significance depicting a small effect size ( Cohen 's d ) on sleep complaints and distractions ( but not memory ) .
CONCLUSIONS	The specific intervention was not superior to the control condition in reducing symptoms of sleep problems and cognitive difficulties at any time point during the 10-month follow-up period .
CONCLUSIONS	Substantial improvements in symptoms over time were seen in both groups .

###25714528
OBJECTIVE	To determine the efficacy of tranilast as an adjunctive therapy in conjunctival autograft .
METHODS	Twenty-nine patients were randomly allocated to the Tranilast Group ( n = 15 ) or the Control Group ( n = 14 ) .
METHODS	The Tranilast Group received a subconjunctival injection of 0.5 % tranilast 30 days prior to surgery .
METHODS	Conjunctival autograft was performed in both groups using fibrin sealant and 0.02 % subconjunctival mitomycin C at the end of the surgery .
METHODS	After the resection of the pterygium , immunohistochemistry was performed with 100 cells to identify epithelial cells positive for transforming growth factor - ( TGF - ) .
METHODS	Subjective symptoms were evaluated using a 5-point scale , and the recurrence rate was assessed .
RESULTS	Both groups showed improvements in their symptoms and similar clinical results .
RESULTS	Compared with the Control Group , the Tranilast Group failed to show a decreased recurrence rate ( p = 0.59 ) .
RESULTS	However , the number of epithelial cells expressing TGF - was lower in the Tranilast Group ( 5 cells ; 95 % CI : 2.56-13 .15 ; Control Group , 16 cells , 95 % CI : 11.53-24 .76 ; p = 0.01 ) .
RESULTS	Minimal but reversible complications , including glaucoma secondary to corticosteroids and granuloma , occurred during the study .
CONCLUSIONS	Tranilast was effective in decreasing the number of pterygium epithelial cells expressing TGF - .

###24733515
OBJECTIVE	Violence and injury risk behaviors , alcohol and drug use problems , and posttraumatic stress disorder ( PTSD ) and depressive symptoms occur frequently among adolescents presenting to acute care medical settings after traumatic physical injury .
OBJECTIVE	To test the effectiveness of a stepped collaborative care intervention targeting this constellation of risk behaviors and symptoms in randomly sampled hospitalized adolescents with and without traumatic brain injury .
METHODS	A pragmatic randomized clinical trial was conducted at a single US level I trauma center .
METHODS	Participants included 120 adolescents aged 12 to 18 years randomized to intervention ( n = 59 ) and control ( n = 61 ) conditions .
METHODS	Stepped collaborative care intervention included motivational interviewing elements targeting risk behaviors and substance use as well as medication and cognitive behavioral therapy elements targeting PTSD and depressive symptoms .
METHODS	Adolescents were assessed at baseline before randomization and 2 , 5 , and 12 months after injury hospitalization .
METHODS	Standardized instruments were used to assess violence risk behaviors , alcohol and drug use , and PTSD and depressive symptoms .
RESULTS	The investigation attained more than 95 % adolescent follow-up at each assessment point .
RESULTS	At baseline , approximately one-third of the participants endorsed the violence risk behavior of carrying a weapon .
RESULTS	Regression analyses demonstrated that intervention patients experienced significant reductions in weapon carrying compared with controls during the year after injury ( grouptime effect , F3 ,344 = 3.0 ; P = .03 ) .
RESULTS	At 12 months after the injury , 4 ( 7.3 % ) intervention patients vs 13 ( 21.3 % ) control patients reported currently carrying a weapon ( relative risk ,0.31 ; 95 % CI , 0.11-0 .90 ) .
RESULTS	The intervention was equally effective in reducing the risk of weapon carrying among injured adolescents with and without traumatic brain injury .
RESULTS	Other treatment targets , including alcohol and drug use problems and high levels of PTSD and depressive symptoms , occurred less frequently in the cohort relative to weapon carrying and were not significantly affected by the intervention .
CONCLUSIONS	Collaborative care intervention reduced the risk of adolescent weapon carrying during the year after the injury hospitalization .
CONCLUSIONS	Future investigation should replicate this preliminary observation .
CONCLUSIONS	If the finding is replicated , orchestrated investigative and policy efforts could systematically implement and evaluate screening and intervention procedures targeting youth violence prevention at US trauma centers .
BACKGROUND	clinicaltrials.gov identifier : NCT00619255 .

###25373935
BACKGROUND	Formula-fed ( FF ) infants often have harder stools and higher stool concentrations of fatty acid soaps compared to breastfed infants .
BACKGROUND	Feeding high sn-2 palmitate or the prebiotic oligofructose ( OF ) may soften stools , reduce stool soaps , and decrease fecal calcium loss .
METHODS	We investigated the effect of high sn-2 palmitate alone and in combination with OF on stool palmitate soap , total soap and calcium concentrations , stool consistency , gastrointestinal ( GI ) tolerance , anthropometrics , and hydration in FF infants .
METHODS	This double-blind trial randomized 165 healthy term infants 25-45 days old to receive Control formula ( n = 54 ) , formula containing high sn-2 palmitate ( sn-2 ; n = 56 ) , or formula containing high sn-2 palmitate plus 3 g/L OF ( sn-2 + OF ; n = 55 ) .
METHODS	A non-randomized human milk ( HM ) - fed group was also included ( n = 55 ) .
METHODS	The primary endpoint , stool composition , was determined after 28 days of feeding , and was assessed using ANOVA accompanied by pairwise comparisons .
METHODS	Stool consistency , GI tolerance and hydration were assessed at baseline , day 14 ( GI tolerance only ) and day 28 .
RESULTS	Infants fed sn-2 had lower stool palmitate soaps compared to Control ( P = 0.0028 ) ; while those fed sn-2 + OF had reduced stool palmitate soaps compared to both Control and sn-2 ( both P < 0.0001 ) .
RESULTS	Stool total soaps and calcium were lower in the sn-2 + OF group than either Control ( P < 0.0001 ) or sn-2 ( P < 0.0001 ) .
RESULTS	The HM-fed group had lower stool palmitate soaps , total soaps and calcium ( P < 0.0001 for each comparison ) than all FF groups .
RESULTS	The stool consistency score of the sn-2 + OF group was lower than Control and sn-2 ( P < 0.0001 ) , but higher than the HM-fed group ( P < 0.0001 ) .
RESULTS	GI tolerance was similar and anthropometric z-scores were < 0.2 SD from the WHO growth standards in all groups , while urinary hydration markers were within normal range for all FF infants .
CONCLUSIONS	Increasing sn-2 palmitate in infant formula reduces stool palmitate soaps .
CONCLUSIONS	A combination of high sn-2 palmitate and OF reduces stool palmitate soaps , total soaps and calcium , while promoting softer stools .
BACKGROUND	This study was registered on http://www.clinicaltrials.gov: number NCT02031003 .

###24385026
BACKGROUND	A number of studies have evaluated the effects of subcutaneous drainage during digestive surgery .
BACKGROUND	All of the previous studies assessed the usefulness of active-suctioning drain , including two randomized controlled studies which found no benefit for the placement of active-suctioning drains in digestive surgery .
BACKGROUND	The utility of passive drainage has not been evaluated previously .
BACKGROUND	The purpose of this study was to evaluate the efficacy of subcutaneous passive drainage system for preventing surgical site infections during major colorectal surgery .
METHODS	A total of 263 patients who underwent major colorectal surgery were enrolled in this study .
METHODS	Patients were randomly assigned to receive subcutaneous passive drainage or no drainage .
METHODS	The primary outcome measured was the incidence of superficial surgical site infections .
METHODS	The secondary outcomes measured were the development of hematomas , seromas , and wound dehiscence .
RESULTS	Finally , a total of 246 patients ( 124 underwent passive drainage , and 122 underwent no drainage ) were included in the analysis after randomization .
RESULTS	There was a significant difference in the incidence of superficial surgical site infections between patients assigned to the passive drainage and no drainage groups ( 3.2 % vs 9.8 % , respectively , P = 0.041 ) .
RESULTS	There were no cases that developed a hematoma , seroma , or wound dehiscence in either group .
RESULTS	A subgroup analysis revealed that male gender , age 75 years , diabetes mellitus , American Society of Anesthesiologists ( ASA ) status 2 , blood loss 100 ml , and open access were factors that were associated with a beneficial effect of subcutaneous passive drainage .
CONCLUSIONS	Subcutaneous passive drainage provides benefits over no drainage in patients undergoing major colorectal surgery .

###24858506
OBJECTIVE	The aim of this study was to elucidate the physiological adjustment effect of forest therapy based on the Law of Initial Value .
METHODS	The experiments were conducted in nine forest and urban areas in Japan during the period from 2011 to 2012 .
METHODS	There were 12 male Japanese university students participating in each of the nine experiments ( total , 108 participants ) .
METHODS	Of these , 98 subjects ( mean age standard deviation , 21.4 1.6 years ) were analyzed .
METHODS	The subjects were instructed to view a real forest landscape or urban area for 15 min .
METHODS	The systolic blood pressure , diastolic blood pressure , and pulse rate of each subject were measured .
METHODS	We analyzed the correlation between the initial values ( after city viewing ) and the differences in values between the two environments ( after forest viewing-after city viewing ) .
RESULTS	There was a negative correlation between the initial values and the differences in values between the two environments .
RESULTS	The subjects whose initial systolic blood pressure , diastolic blood pressure , and pulse rate were high showed marked decreases in these parameters as their response after viewing the forest environment , whereas those whose initial systolic blood pressure , diastolic blood pressure , and pulse rate were low showed increases in these parameters as their response .
CONCLUSIONS	These results support the premise that the physiological effect of a forest environment can differ depending on a subject 's initial response values .
CONCLUSIONS	Moreover , it was clear that forest therapy caused physiological adjustment , normalizing blood pressure and pulse rate .

###25027230
BACKGROUND	The most important action in the resuscitation of a newborn in the delivery room is to establish effective assisted ventilation .
BACKGROUND	The face mask and endotracheal tube are the devices used to achieve this goal .
BACKGROUND	Laryngeal mask airways that fit over the laryngeal inlet have been shown to be effective for ventilating newborns at birth and should be considered as an alternative to facemask ventilation or endotracheal intubation among newborns weighing > 2,000 g or delivered 34weeks ' gestation .
BACKGROUND	A recent systematic review and meta-analysis of supraglottic airways in neonatal resuscitation reported the results of four randomized controlled trials ( RCTs ) stating that fewer infants in the group using laryngeal mask airways required endotracheal intubation ( 1.5 % ) compared to the group using face masks ( 12.0 % ) .
BACKGROUND	However , there were methodological concerns over all the RCTs including the fact that the majority of the operators in the trials were anesthesiologists.Our hypothesis is based on the assumption that ventilating newborns needing positive pressure ventilation with a laryngeal mask airway will be more effective than ventilating with a face mask in a setting where neonatal resuscitation is performed by midwives , nurses , and pediatricians .
BACKGROUND	The primary aim of this study will be to assess the effectiveness of the laryngeal mask airway over the face mask in preventing the need for endotracheal intubation .
METHODS	This will be an open , prospective , randomized , single center , clinical trial .
METHODS	In this study , 142 newborns weighing > 1,500 g or delivered 34weeks gestation needing positive pressure ventilation at birth will be randomized to be ventilated with a laryngeal mask airway ( LMA SupremeTM , LMA Company , UK - intervention group ) or with a face mask ( control group ) .
METHODS	Proportion of newborns needing endotracheal intubation .
RESULTS	Apgar score at 5minutes , time to first breath , onset of the first cry , duration of resuscitation , death or moderate to severe hypoxic-ischemic encephalopathy within 7days of life .
BACKGROUND	ClinicalTrials.gov identifier : NCT01963936 ( October 11 , 2013 ) .

###25429531
BACKGROUND	Hypertonic citrate adenine ( HC-A ) solution , containing citrate and adenine , has become the most widely used preservation solution in isolated kidney preservation in China .
BACKGROUND	More than 30 years of clinical application has demonstrated that HC-A is safe and effective .
BACKGROUND	With higher requirement for kidney preservation and less tolerance of preservation-related graft dysfunction , a new solution , HC-A II , for kidney preservation was developed by Shanghai Changzheng Hospital .
METHODS	Upon approval from the State Food and Drug Administration of China ( SFDA ) , a multi-center randomized controlled trial was performed to study the efficacy and safety of HC-A II in kidney preservation from 2008 to 2012 , using histidine-tryptophan-ketoglutarate solution ( HTK ) as control ( HC-A , n = 137 , and HTK , n = 140 ) .
METHODS	There were no differences with regard to donor and recipient demographics or cold ischemia .
RESULTS	The trial results showed no significant difference in DGF rate , or patient or graft survival between the 2 groups .
RESULTS	No significant difference between the 2 groups was found in the percentage of patients whose serum creatinine ( SCr ) test results returned to normal within 28 days ( P > 0.05 ) , nor were there a significant difference in safety evaluation ( P > 0.05 ) .
CONCLUSIONS	HC-A II and HTK appear to have similar efficacy in isolated kidney preservation .

###24308890
OBJECTIVE	Prevention research has to elucidate how families with overweight children can be convinced to participate in obesity intervention trials .
OBJECTIVE	Here we describe the detailed recruitment process for a telephone-based obesity prevention programme for families with overweight children and present participation rates , the study design and a socio-demographic description of participating families .
METHODS	Overweight ( BMI > 90th percentile ) children and adolescents 4-17 years of age were screened via the German paediatrician network CrescNet .
METHODS	The prevention programme ( multiple computer aided telephone counselling interviews ) was suggested to eligible families via local paediatricians .
METHODS	Participating families were compared anthropometrically and socio-demographically to the entire screening population and to micro-census data , a representative national survey .
RESULTS	The screening process assessed 4005 candidates for eligibility .
RESULTS	Paediatricians reported having suggested programme participation to 3387 candidates ( referred to as 100 % ) .
RESULTS	427 candidates ( 12.6 % ) returned a written consent for programme participation .
RESULTS	303 candidates ( 9.0 % ) started the intervention .
RESULTS	The study population ( n = 303 ) included more obese ( 45.6 % vs. 33.2 % ; p < 0.001 ) and fewer overweight participants ( 40.4 % vs. 55.2 % ; p < 0.001 ) than the entire screening population .
RESULTS	Compared to the micro-census , families with adolescents ( 8.2 % vs. 16.9 % ; p < 0.001 ) and single parents ( 16.0 % vs. 23.3 % ; p < 0.005 ) were underrepresented in the study population , whereas families living in rural areas were overrepresented ( 58.7 % vs. 50.2 % ; p < 0.005 ) .
CONCLUSIONS	Although 84.6 % of the paediatricians forwarded the suggestion for programme participation to eligible families , participation rates for this low-threshold ; telephone-based obesity intervention remained very low .
CONCLUSIONS	`` Hard-to-engage groups '' for effective obesity prevention seem to include single parents , as well as parents of adolescents .

###24673858
OBJECTIVE	To examine the cardiopulmonary effects of infusions of remifentanil or morphine , and their influence on recovery of horses anesthetized with isoflurane and dexmedetomidine .
METHODS	Randomized crossover study with 7-day rest periods .
METHODS	Six adult horses ( 507 61 kg ) .
METHODS	After the horses were sedated with xylazine , anaesthesia was induced with ketamine and diazepam , and maintained with isoflurane .
METHODS	After approximately 60 minutes , a dexmedetomidine infusion was started ( 0.25 g kg ( -1 ) then 1.0 g ( -1 ) kg ( -1 ) hour ( -1 ) ) in combination with either saline ( group S ) , morphine ( 0.15 mg kg ( -1 ) then 0.1 mg kg ( -1 ) hour ( -1 ) ; group M ) , or remifentanil ( 6.0 g kg ( -1 ) hour ( -1 ) ; group R ) for 60 minutes .
METHODS	Mean arterial pressure , heart rate , end-tidal carbon dioxide tension , and end-tidal isoflurane concentration were recorded every 5 minutes .
METHODS	Core body temperature , cardiac output , right ventricular and arterial blood-gas values were measured every 15 minutes .
METHODS	Cardiac index , systemic vascular resistance ( SVR ) , intrapulmonary shunt fraction , alveolar dead space , oxygen delivery and extraction ratio were calculated .
METHODS	Recoveries were videotaped and scored by two observers blinded to the treatment .
METHODS	Data were analyzed using repeated measures anova followed by Dunnett 's or Bonferroni 's significant difference test .
METHODS	Recovery scores were analyzed using a Kruskal-Wallis test .
RESULTS	No significant differences were found among groups .
RESULTS	Compared to baseline , heart rate decreased and SVR increased significantly in all groups , and cardiac index significantly decreased in groups S and M. Hemoglobin concentration , oxygen content and oxygen delivery significantly decreased in all groups .
RESULTS	The oxygen extraction ratio significantly increased in groups M and R. Lactate concentration significantly increased in group S. Recovery scores were similar among groups .
CONCLUSIONS	Dexmedetomidine alone or in combination with remifentanil or morphine infusions was infused for 60 minutes without adverse effects in the 6 healthy isoflurane-anesthetized horses in this study .

###24888857
OBJECTIVE	It is well established through randomized trials that oral antibiotics given with or without a mechanical bowel preparation ( MBP ) prior to colorectal procedures reduce complications , while MBP given alone provides no benefit .
OBJECTIVE	We aimed to characterize trends surrounding bowel preparation in children and determine whether contemporary practice is evidence-based .
METHODS	Retrospective analysis of patients undergoing colorectal procedures at 42 children 's hospitals ( 1/2/2007 -12 / 31/2011 ) was performed .
METHODS	Patients were analyzed for diagnosis , pre-admission status , and inpatient bowel preparation .
METHODS	Bowel preparation was considered evidence-based if oral antibiotics were utilized with or without a MBP .
RESULTS	49 % of all patients were pre-admitted ( n = 5,473 ) , and the most common diagnoses were anorectal malformations ( 55 % ) , inflammatory bowel disease ( 26 % ) , and Hirschsprung 's Disease ( 19 % ) .
RESULTS	The most common preparation approaches were MBP alone ( 54.3 % ) , MBP + oral antibiotics ( 18.8 % ) , and oral antibiotics alone ( 4.2 % ) , although significant variation was found in hospital-specific rates for each approach ( MBP alone : 0-96 .1 % , MBP + oral antibiotics : 0-83 .6 % , orals alone : 0-91 .6 % , p < 0.0001 ) .
RESULTS	Only 22.9 % of all patients received an evidence-based preparation ( range by hospital : 0-92 .3 % , p < 0.0001 ) , and this rate decreased significantly during the five-year study period ( 27.6 % in 2007 vs. 17.3 % in 2011 , p < 0.0001 ) .
CONCLUSIONS	According to the best available clinical evidence , less than a quarter of all children pre-admitted for elective colorectal procedures receive a bowel preparation proven to reduce infectious complications .

###24249841
OBJECTIVE	To assess the effects of short-term resistance training and pulsed electromagnetic fields on bone metabolism and joint function in patients with haemophilia with osteoporosis .
METHODS	A randomized , controlled , patient and blood sample assessor-blinded , six-week trial , three times weekly .
METHODS	Hospital outpatients with severe haemophilia A and osteoporosis .
METHODS	Forty-eight patients were randomly assigned to resistance training ( RT , n = 13 ) , combined resistance training with pulsed electromagnetic fields ( RTPEMF , n = 12 ) , pulsed electromagnetic fields ( PEMF , n = 11 ) and control ( n = 12 ) groups .
METHODS	The RT group received 30-40 minutes of resistance exercises and placebo pulsed electromagnetic fields .
METHODS	The RTPEMF group received the same exercises with lower repetition and 30 minutes of pulsed electromagnetic fields .
METHODS	The PEMF group was exposed to 60 minutes of pulsed electromagnetic fields ( 30 Hz and 40 Gauss ) .
METHODS	Bone-specific alkaline phosphatase , N-terminal telopeptide of type 1 collagen , and joint function , using the modified Colorado Questionnaire , were measured before and after the programme .
RESULTS	The absolute change of bone-specific alkaline phosphatase was significant in the RT and RTPEMF groups compared with the control group ( 25.41 14.40 , 15.09 5.51 , and -4.73 2.93 U/L , respectively ) .
RESULTS	The absolute changes in the total score for joint function were significant for knees , ankles , and elbows in the RT group ( 9.2 1.38 , 5.1 0.5 , and 3.2 0.8 , respectively ) and the RTPEMF group ( 7.7 1.0 , 3.3 0.6 , and 2.5 0.7 , respectively ) compared to the PEMF and control groups .
RESULTS	This value was significant for knee joints in the PEMF group compared to the control group ( 3.4 0.5 and 0.66 0.4 , respectively ) .
CONCLUSIONS	Resistance training is effective for improving bone formation and joint function in severe haemophilia A patients with osteoporosis .

###25409838
BACKGROUND	This study compares the long-term results of pneumatic dilatations versus laparoscopic myotomy using treatment failure as the primary outcome .
BACKGROUND	The frequency and degree of dysphagia , the effects on quality of life ( QoL ) , and health economy were also examined .
METHODS	Fifty-three patients with achalasia were randomized to laparoscopic myotomy with a posterior partial fundoplication [ laparoscopic myotomy ( LM ) n = 25 ] or repetitive pneumatic dilatation [ pneumatic dilatation ( PD ) n = 28 ] .
METHODS	The median observation period was 81.5 months ( range 12-131 ) .
RESULTS	At the minimal follow-up of 5 years , ten patients ( 36 % ) in the dilatation group and two patients ( 8 % ) in the myotomy group , including two patients lost to follow-up ( one in each arm ) , were classified as failures ( p = 0.016 ) .
RESULTS	The cumulative incidence of treatment failures was analyzed by survival statistics .
RESULTS	Taking the entire follow-up period into account , a significant difference was observed in favor of the LM strategy ( p = 0.02 ) .
RESULTS	Although both treatments resulted in significant improvements in dysphagia scores , LM was significantly favored over PD after 1 and 3 years , but not after 5 years .
RESULTS	Health-related QoL assessed by the personal general well being score was higher in the LM group after 3 years , but the difference was not fully statistically significant at 5 years .
RESULTS	Direct medical costs during the entire follow-up period were in median $ 13,421 for LM as compared to $ 5,558 for PD ( p = 0.001 ) .
CONCLUSIONS	This long-term follow-up of a randomized clinical study shows that LM is superior to repetitive PD treatment of newly diagnosed achalasia , albeit that this surgical strategy is burdened by high initial direct medical costs .
CONCLUSIONS	www.ClinicalTrials.gov NCT 02086669 .

###24521153
BACKGROUND	Individual barriers to weight loss and physical activity goals in the Diabetes Prevention Program , a randomized trial with 3.2 years average treatment duration , have not been previously reported .
BACKGROUND	Evaluating barriers and the lifestyle coaching approaches used to improve adherence in a large , diverse participant cohort can inform dissemination efforts .
METHODS	Lifestyle coaches documented barriers and approaches after each session ( mean session attendance = 50.321.8 ) .
METHODS	Subjects were 1076 intensive lifestyle participants ( mean age = 50.6 years ; mean BMI = 33.9 kg/m ; 68 % female , 48 % non-Caucasian ) .
METHODS	Barriers and approaches used to improve adherence were ranked by the percentage of the cohort for whom they applied .
METHODS	Barrier groupings were also analyzed in relation to baseline demographic characteristics .
RESULTS	Top weight loss barriers reported were problems with self-monitoring ( 58 % ) ; social cues ( 58 % ) ; holidays ( 54 % ) ; low activity ( 48 % ) ; and internal cues ( thought/mood ) ( 44 % ) .
RESULTS	Top activity barriers were holidays ( 51 % ) ; time management ( 50 % ) ; internal cues ( 30 % ) ; illness ( 29 % ) , and motivation ( 26 % ) .
RESULTS	The percentage of the cohort having any type of barrier increased over the long-term intervention period .
RESULTS	A majority of the weight loss barriers were significantly associated with younger age , greater obesity , and non-Caucasian race/ethnicity ( p-values vary ) .
RESULTS	Physical activity barriers , particularly thought and mood cues , social cues and time management , physical injury or illness and access/weather , were most significantly associated with being female and obese ( p < 0.001 for all ) .
RESULTS	Lifestyle coaches used problem-solving with most participants ( 75 % short-term ; > 90 % long term ) and regularly reviewed self-monitoring skills .
RESULTS	More costly approaches were used infrequently during the first 16 sessions ( 10 % ) but increased over 3.2 years .
CONCLUSIONS	Behavioral problem solving approaches have short and long term dissemination potential for many kinds of participant barriers .
CONCLUSIONS	Given minimal resources , increased attention to training lifestyle coaches in the consistent use of these approaches appears warranted .

###24241957
BACKGROUND	Lack of universal , annual testing for human immunodeficiency virus ( HIV ) in health facilities suggests that expansion of HIV testing and counselling ( HTC ) to non-clinical settings is critical to the achievement of national goals for prevention , care and treatment .
BACKGROUND	Consideration should be given to the ability of lay counsellors to perform home-based HTC in community settings .
METHODS	We implemented a community cluster randomized controlled trial of home-based HTC in Sisonke District , South Africa .
METHODS	Trained lay counsellors conducted door-to-door HIV testing using the same rapid tests used by the local health department at the time of the study ( SD Bioline and Sensa ) .
METHODS	To monitor testing quality and counsellor skill , additional dry blood spots were taken and sent for laboratory-based enzyme-linked immunosorbent assay ( ELISA ) testing .
METHODS	Sensitivity and specificity were calculated using the laboratory result as the gold standard .
CONCLUSIONS	From 3986 samples , the counsellor and laboratory results matched in all but 23 cases .
CONCLUSIONS	In 18 cases , the counsellor judged the result as indeterminate , whereas the laboratory judged 10 positive , eight negative and three indeterminate , indicating that the counsellor may have erred on the side of caution .
CONCLUSIONS	Sensitivity was 98.0 % ( 95 % CI : 96.3-98 .9 % ) , and specificity 99.6 % ( 95 % CI : 99.4-99 .7 % ) , for the lay counsellor field-based rapid tests .
CONCLUSIONS	Both measures are high , and the lower confidence bound for specificity meets the international standard for assessing HIV rapid tests .
CONCLUSIONS	These findings indicate that adequately trained lay counsellors are capable of safely conducting high-quality rapid HIV tests and interpreting the results as per the kit guidelines .
CONCLUSIONS	These findings are important given the likely expansion of community and home-based testing models and the shortage of clinically trained professional staff .

###24221841
BACKGROUND	Comparison of a multimodal intervention WE CALL ( study initiated phone support/information provision ) versus a passive intervention YOU CALL ( participant can contact a resource person ) in individuals with first mild stroke .
RESULTS	This study is a single-blinded randomized clinical trial .
RESULTS	Primary outcome includes unplanned use of health services ( participant diaries ) for adverse events and quality of life ( Euroquol-5D , Quality of Life Index ) .
RESULTS	Secondary outcomes include planned use of health services ( diaries ) , mood ( Beck Depression Inventory II ) , and participation ( Assessment of Life Habits [ LIFE-H ] ) .
RESULTS	Blind assessments were done at baseline , 6 , and 12 months .
RESULTS	A mixed model approach for statistical analysis on an intention-to-treat basis was used where the group factor was intervention type and occasion factor time , with a significance level of 0.01 .
RESULTS	We enrolled 186 patients ( WE = 92 ; YOU = 94 ) with a mean age of 62.5 12.5 years , and 42.5 % were women .
RESULTS	No significant differences were seen between groups at 6 months for any outcomes with both groups improving from baseline on all measures ( effect sizes ranged from 0.25 to 0.7 ) .
RESULTS	The only significant change for both groups from 6 months to 1 year ( n = 139 ) was in the social domains of the LIFE-H ( increment in score , 0.4 / 9 1.3 [ 95 % confidence interval , 0.1-0 .7 ] ; effect size , 0.3 ) .
RESULTS	Qualitatively , the WE CALL intervention was perceived as reassuring , increased insight , and problem solving while decreasing anxiety .
RESULTS	Only 6 of 94 ( 6.4 % ) YOU CALL participants availed themselves of the intervention .
CONCLUSIONS	Although the 2 groups improved equally over time , WE CALL intervention was perceived as helpful , whereas YOU CALL intervention was not used .
BACKGROUND	URL : http://www.controlled-trials.com .
BACKGROUND	Unique identifier : ISRCTN95662526 .

###26016866
BACKGROUND	The consumption of citrus fruits is associated with health benefits .
BACKGROUND	However , clinical data regarding the effects of grapefruit flavanone consumption on vascular function are lacking .
OBJECTIVE	The objective of the present study was to address the role of flavanones in the long-term effects induced by grapefruit juice ( GFJ ) consumption on vascular function in healthy postmenopausal women .
METHODS	Forty-eight healthy postmenopausal women aged 50-65 y within 3-10 y since menopause , a body mass index ( in kg/m ( 2 ) ) of 19-30 , and a waist size > 88 cm completed this double-blind , randomized , controlled , crossover trial .
METHODS	These volunteers were randomly assigned to consume 340 mL GFJ/d , providing 210 mg naringenin glycosides , or a matched control drink without flavanones for 6 mo each , with a 2-mo washout between beverages .
METHODS	The primary endpoint was the assessment of endothelial function in the brachial artery by using flow-mediated dilation .
METHODS	Blood pressure , arterial stiffness , and endothelial function in the peripheral arterial bed were also evaluated as indicators of vascular function .
METHODS	These measurements and blood collection for clinical biochemical markers were performed in overnight-fasted subjects before and after the 6-mo treatment periods .
RESULTS	The mean SD carotid-femoral pulse wave velocity , which reflects central aortic stiffness , was statistically significantly lower after consumption of GFJ ( 7.36 1.15 m/s ) than after consumption of the matched control drink without flavanones ( 7.70 1.36 m/s ) , with a P value of 0.019 for the treatment effect .
RESULTS	Endothelial function in macro - and microcirculation , blood pressure , anthropometric measures , glucose metabolism , and biomarkers of inflammation and oxidative stress were not affected by the intervention .
CONCLUSIONS	Regular GFJ consumption by middle-aged , healthy postmenopausal women is beneficial for arterial stiffness .
CONCLUSIONS	This effect may be related to flavanones present in grapefruit .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01272167 .

###24817084
OBJECTIVE	Compare public perceptions and intentions to undergo colorectal cancer screening tests following detailed information regarding CT colonography ( CTC ; after non-laxative preparation or full-laxative preparation ) , optical colonoscopy ( OC ) or flexible sigmoidoscopy ( FS ) .
METHODS	A total of 3,100 invitees approaching screening age ( 45-54 years ) were randomly allocated to receive detailed information on a single test and asked to return a questionnaire .
METHODS	Outcomes included perceptions of preparation and test tolerability , health benefits , sensitivity and specificity , and intention to undergo the test .
RESULTS	Six hundred three invitees responded with valid questionnaire data .
RESULTS	Non-laxative preparation was rated more positively than enema or full-laxative preparations [ effect size ( r ) = 0.13 to 0.54 ; p < 0.0005 to 0.036 ] ; both forms of CTC and FS were rated more positively than OC in terms of test experience ( r = 0.26 to 0.28 ; all p-values < 0.0005 ) .
RESULTS	Perceptions of health benefits , sensitivity and specificity ( p = 0.250 to 0.901 ) , and intention to undergo the test ( p = 0.213 ) did not differ between tests ( n = 144-155 for each test ) .
CONCLUSIONS	Despite non-laxative CTC being rated more favourably , this study did not find evidence that offering it would lead to substantially higher uptake than full-laxative CTC or other methods .
CONCLUSIONS	However , this study was limited by a lower than anticipated response rate .
CONCLUSIONS	Improving uptake of colorectal cancer screening tests could improve health benefits Potential invitees rate CTC and flexible sigmoidoscopy more positively than colonoscopy Non-laxative bowel preparation is rated better than enema or full-laxative preparations These positive perceptions alone may not be sufficient to improve uptake Health benefits and accuracy are rated similarly for preventative screening tests .

###24531027
OBJECTIVE	To describe the incidence and outcomes of reoperations for glaucoma in the Tube Versus Trabeculectomy ( TVT ) Study .
METHODS	Cohort study of patients in a multicenter randomized clinical trial .
METHODS	The TVT Study enrolled 212 patients with medically uncontrolled glaucoma who had previous cataract and/or glaucoma surgery .
METHODS	Randomization assigned 107 patients to surgery with a tube shunt ( 350 mm ( 2 ) Baerveldt glaucoma implant ) and 105 patients to trabeculectomy with mitomycin C ( 0.4 mg/mL for 4 minutes ) .
METHODS	Data were analyzed from patients who failed their assigned treatment and had additional glaucoma surgery .
METHODS	Outcome measures included intraocular pressure ( IOP ) , use of glaucoma medications , visual acuity , surgical complications , and failure ( IOP > 21 mm Hg or not reduced by 20 % , IOP 5 mm Hg , additional glaucoma surgery , or loss of light perception vision ) .
RESULTS	Additional glaucoma surgery was performed in 8 patients in the tube group and 18 patients in the trabeculectomy group in the TVT Study , and the 5-year cumulative reoperation rate was 9 % in the tube group and 29 % in the trabeculectomy group ( P = .025 ) .
RESULTS	Follow-up ( mean SD ) after additional glaucoma surgery was 28.0 16.0 months in the tube group and 30.5 20.4 months in the trabeculectomy group ( P = .76 ) .
RESULTS	At 2 years after a glaucoma reoperation , IOP ( mean SD ) was 15.0 5.5 mm Hg in the tube group and 14.4 6.6 mm Hg in the trabeculectomy group ( P = .84 ) .
RESULTS	The number of glaucoma medications ( mean SD ) after 2 years of follow-up was 1.1 1.3 in the tube group and 1.4 1.4 in the trabeculectomy group ( P = .71 ) .
RESULTS	The cumulative probability of failure at 1 , 2 , 3 , and 4 years after additional glaucoma surgery was 0 % , 43 % , 43 % , and 43 % , respectively , in the tube group , and 0 % , 9 % , 20 % , and 47 % in the trabeculectomy group ( P = .28 ) .
RESULTS	Reoperations to manage complications were required in 1 patient in the tube group and 5 patients in the trabeculectomy group ( P = .63 ) .
CONCLUSIONS	The rate of reoperation for glaucoma was higher following trabeculectomy with mitomycin C than tube shunt surgery in the TVT Study .
CONCLUSIONS	Similar surgical outcomes were observed after additional glaucoma surgery , irrespective of initial randomized treatment in the study .

###24267729
BACKGROUND	Blockade of platelet activation and aggregation can inhibit metastasis in preclinical models and is associated with cancer prevention .
BACKGROUND	To test whether disruption of platelet function with clopidogrel and aspirin would decrease the number of circulating tumor cells ( CTCs ) in patients with metastatic breast cancer , a randomized phase II study was performed .
METHODS	Patients with metastatic breast cancer who were not currently receiving cytotoxic chemotherapy were eligible .
METHODS	Patients were randomized to receive either clopidogrel and aspirin or to a control group receiving no treatment .
METHODS	Phlebotomy was performed at baseline , at 2 and 4 weeks , and monthly thereafter to obtain specimens to assess CTC , platelet aggregation , and thrombin activity .
METHODS	The primary end point was the proportion of patients with detectable CTCs at 1 month .
RESULTS	Forty-eight patients were enrolled and 42 were evaluable at 1month .
RESULTS	Baseline CTC numbers were 5 in 13 % and 1 in 65 % of patients .
RESULTS	Despite adequate platelet function inhibition in the treatment group , the proportion of patients with detectable CTCs was similar between the clopidogrel/aspirin and control groups at baseline ( P = .21 ) and 4 weeks ( P = .75 ) , showing no treatment effect .
RESULTS	Measured endogenous thrombin potential did not correlate with CTC number .
RESULTS	No bleeding-related serious adverse events ( SAEs ) occurred .
CONCLUSIONS	The baseline CTC numbers were lower than expected , decreasing the ability to detect an impact of platelet inhibition on CTCs .
CONCLUSIONS	Clopidogrel and aspirin were well tolerated .
CONCLUSIONS	Future studies evaluating the potential therapeutic role of antiplatelet therapy in breast cancer remain of interest , and they may be informed by theseresults .

###25213339
OBJECTIVE	The Carotid Revascularization Endarterectomy Versus Stenting Trial was completed with a low stroke and death rate .
OBJECTIVE	A lead-in series of patients receiving carotid artery stenting was used to select the physician-operators for the study , where performance was evaluated by complication rates and by peer review of cases .
OBJECTIVE	Herein , we assess the potential contribution of statistical evaluation of complication rates .
METHODS	The ability to discriminate between stent operators who can successfully meet the published guideline of < 3 % combined rate of stroke and death is calculated under the binomial distribution , based on a small consecutive case series ( n = 24 patients ) .
RESULTS	A criterion of 2 stroke or death events among the 24 patients ( < 8 % event rate ) was required of operators .
RESULTS	Setting such a high criterion , however , ensures an inability to exclude operators who can not meet the criteria .
RESULTS	In fact , if a good operator is defined as having a 2 % event rate and a poor operator as a 6 % event rate , even a series of 240 patients would ( on average ) still exclude 5.4 % of the good operators and include 4.6 % of the poor operators .
CONCLUSIONS	The low periprocedural event rates in the trial suggest success in separating skillful operators from less skillful .
CONCLUSIONS	However , it seems unlikely that statistical assessment of event rates in the lead-in contributed to successful selection , but rather successful selection was more likely because of peer review of subjective and other factors including patient volume and technical approaches .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00004732 .

###25557208
OBJECTIVE	The objective of the study was to compare long-term results of subtotal vs total abdominal hysterectomy for benign uterine diseases 14 years after hysterectomy , with urinary incontinence as the primary outcome measure .
METHODS	This was a long-term follow-up of a multicenter , randomized clinical trial without blinding .
METHODS	Eleven gynecological departments in Denmark contributed participants to the trial .
METHODS	Women referred for benign uterine diseases who did not have contraindications to subtotal abdominal hysterectomy were randomized to subtotal ( n = 161 ) vs total ( n = 158 ) abdominal hysterectomy .
METHODS	All women enrolled in the trial from 1996 to 2000 who were still alive and living in Denmark ( n = 304 ) were invited to answer the validated questionnaire used in prior 1 and 5 year follow-ups .
METHODS	Hospital contacts possibly related to hysterectomy from 5 to 14 years postoperatively were registered from discharge summaries from all public hospitals in Denmark .
METHODS	The results were analyzed as intention to treat and per protocol .
METHODS	Possible bias caused by missing data was handled by multiple imputation .
METHODS	The primary outcome was urinary incontinence ; the secondary outcomes were pelvic organ prolapse , constipation , pain , sexuality , quality of life ( Short Form-36 questionnaire ) , hospital contacts , and vaginal bleeding .
RESULTS	The questionnaire was answered by 197 of 304 women ( 64.8 % ) ( subtotal hysterectomy [ n = 97 ] [ 63.4 % ] ; total hysterectomy [ n = 100 ] [ 66.2 % ] ) .
RESULTS	Mean follow-up time was 14 years and mean age at follow-up was 60.1 years .
RESULTS	After subtotal abdominal hysterectomy , 32 of 97 women ( 33 % ) complained of urinary incontinence compared with 20 of 100 women ( 20 % ) after total abdominal hysterectomy 14 years after hysterectomy ( relative risk , 1.67 ; 95 % confidence interval , 1.02-2 .70 ; P = .035 ) .
RESULTS	After a multiple imputation analysis , this difference disappeared ( relative risk , 1.36 ; 95 % confidence interval , 0.86-2 .13 ; P = .19 ) .
RESULTS	No differences were seen in any of the secondary outcomes .
CONCLUSIONS	Subtotal abdominal hysterectomy was not superior to total abdominal hysterectomy on any outcomes .
CONCLUSIONS	More women seem to have subjective urinary incontinence 14 years after subtotal abdominal hysterectomy .
CONCLUSIONS	This result was not confirmed by multiple imputation analysis and should be interpreted cautiously .

###24937346
BACKGROUND	Enterococci , the second leading cause of health care-associated infections , have evolved from commensal and harmless organisms to multidrug-resistant bacteria associated with a significant increase in patient morbidity and mortality .
BACKGROUND	Prevention of ongoing spread of this organism within and between hospitals is important .
BACKGROUND	In this study , we characterized Enterococcus transmission dynamics for bacterial reservoirs commonly encountered by anesthesia providers during the routine administration of general anesthesia .
METHODS	Enterococcus isolates previously obtained from bacterial reservoirs frequently encountered by anesthesiologists ( patient nasopharynx and axilla , anesthesia provider hands , and the adjustable pressure-limiting valve and agent dial of the anesthesia machine ) at 3 major academic medical centers were identified as possible intraoperative bacterial transmission events by class of pathogen , temporal association , and phenotypic analysis ( analytical profile indexing ) .
METHODS	They were then subjected to antibiotic disk diffusion sensitivity for transmission event confirmation .
METHODS	Isolates involved in confirmed transmission events were further analyzed to characterize the frequency , mode , origin , location of transmission events , and antibiotic susceptibility of transmitted pathogens .
RESULTS	Three hundred eighty-nine anesthesia reservoir isolates were previously identified by gross morphology and simple rapid tests as Enterococcus .
RESULTS	The combination of further analytical profile indexing analysis and temporal association implicated 43 % ( 166/389 ) of those isolates in possible intraoperative bacterial transmission events .
RESULTS	Approximately , 30 % ( 49/166 ) of possible transmission events were confirmed by additional antibiotic disk diffusion analysis .
RESULTS	Two phenotypes , E5 and E7 , explained 80 % ( 39/49 ) of confirmed transmission events .
RESULTS	For both phenotypes , provider hands were a common reservoir of origin proximal to the transmission event ( 96 % [ 72/75 ] hand origin for E7 and 89 % [ 50/56 ] hand origin for E5 ) and site of transmission ( 94 % [ 16/17 ] hand transmission location for E7 and 86 % [ 19/22 ] hand transmission location for E5 ) .
CONCLUSIONS	Anesthesia provider hand contamination is a common proximal source and transmission location for Enterococcus transmission events in the anesthesia work area .
CONCLUSIONS	Future work should evaluate the impact of intraoperative hand hygiene improvement strategies on the dynamics of intraoperative Enterococcus transmission .

###25627186
OBJECTIVE	To describe quantitative and qualitative features of eyes with advanced bullous keratopathy assessed using ultrasound biomicroscopy , before and after anterior stromal puncture ( ASP ) or amniotic membrane transplantation ( AMT ) procedures to relieve chronic pain .
METHODS	The present descriptive comparative study included 40 eyes of 40 patients with chronic intermittent pain due to bullous keratopathy who were randomly assigned to one of the two treatments ( AMT or ASP ) .
METHODS	Ultrasound biomicroscopy ( Humphrey , UBM 840 , 50 MHz transducer , immersion technique ) was used , and a questionnaire about pain intensity was completed preoperatively and postoperatively at days 90 and 180 , respectively .
METHODS	Exclusion criteria were age < 18 years , presence of concurrent infection , ocular hypertension , and absence of pain .
RESULTS	In a 180-day follow-up , the AMT group exhibited mean central corneal thickness ( CCT ) , 899.4 m preoperatively and 1122.5 m postoperatively ( p < 0.001 ) ; mean epithelial thickness ( ET ) , 156.4 m preoperatively and 247.8 m postoperatively ( p < 0.001 ) ; and mean stromal thickness ( ST ) , 742.9 m preoperatively and 826.3 m postoperatively ( p = 0.005 ) .
RESULTS	The ASP group exhibited mean CCT , 756.7 m preoperatively and 914.8 m postoperatively ( p < 0.001 ) ; mean ET , 102.1 m preoperatively and 245.2 m postoperatively ( p < 0.001 ) ; and mean ST , 654.6 m preoperatively and 681.5 m postoperatively ( p < 0.999 ) .
RESULTS	Correlations between CCT and pain intensity in the AMT group ( p = 0.209 pre - and postoperatively ) and the ASP group ( p = 0.157 preoperatively and p = 0.426 at the 180-day follow-up ) were not statistically significant .
RESULTS	Epithelial and stromal edema , Descemet 's membrane folds , epithelial bullae , and the presence of interface fluid were frequently observed qualitative features .
CONCLUSIONS	CCT increased over time in both groups .
CONCLUSIONS	The magnitude of CCT did not correlate with pain intensity in the sample studied .
CONCLUSIONS	The presence of interface fluid was a qualitative feature specifically found in some patients who underwent AMT .

###24570141
OBJECTIVE	The association between low birthweight ( LBW ) and risk of developing type 2 diabetes may involve epigenetic mechanisms , with skeletal muscle being a prime target tissue .
OBJECTIVE	Differential DNA methylation patterns have been observed in single genes in muscle tissue from type 2 diabetic and LBW individuals , and we recently showed multiple DNA methylation changes during short-term high-fat overfeeding in muscle of healthy people .
OBJECTIVE	In a randomised crossover study , we analysed genome-wide DNA promoter methylation in skeletal muscle of 17 young LBW men and 23 matched normal birthweight ( NBW ) men after a control and a 5 day high-fat overfeeding diet .
METHODS	DNA methylation was measured using Illumina 's Infinium BeadArray covering 27,578 CpG sites representing 14,475 different genes .
RESULTS	After correction for multiple comparisons , DNA methylation levels were found to be similar in the LBW and NBW groups during the control diet .
RESULTS	Whereas widespread DNA methylation changes were observed in the NBW group in response to high-fat overfeeding , only a few methylation changes were seen in the LBW group ( ( 2 ) , p < 0.001 ) .
CONCLUSIONS	Our results indicate lower DNA methylation plasticity in skeletal muscle from LBW vs NBW men , potentially contributing to understanding the link between LBW and increased risk of type 2 diabetes .

###24630081
OBJECTIVE	To investigate the efficacy and safety of ulipristal acetate ( UPA ) for long-term treatment of symptomatic uterine fibroids .
METHODS	Repeated intermittent open-label UPA courses , each followed by randomized double-blind norethisterone acetate ( NETA ) or placebo .
METHODS	European clinical gynecology centers .
METHODS	Two hundred and nine women with symptomatic fibroids including heavy menstrual bleeding .
METHODS	Patients received up to four 3-month courses of UPA 10 mg daily , immediately followed by 10-day double-blind treatment with NETA ( 10 mg daily ) or placebo .
METHODS	Amenorrhea , fibroid volume , endometrial histology .
RESULTS	After the first UPA course , amenorrhea occurred in 79 % of women , with median onset ( from treatment start ) of 4 days ( interquartile range , 2-6 days ) .
RESULTS	Median fibroid volume change was -45 % ( interquartile range , -66 % ; -25 % ) .
RESULTS	Amenorrhea rates were 89 % , 88 % , and 90 % for the 131 , 119 , and 107 women who received treatment courses 2 , 3 , and 4 , respectively .
RESULTS	Median times to amenorrhea were 2 , 3 , and 3 days for treatment courses 2 , 3 , and 4 , respectively .
RESULTS	Median fibroid volume changes from baseline were -63 % , -67 % , and -72 % after treatment courses 2 , 3 , and 4 , respectively .
RESULTS	All endometrial biopsies showed benign histology without hyperplasia ; NETA did not affect fibroid volume or endometrial histology .
CONCLUSIONS	Repeated 3-month UPA courses effectively control bleeding and shrink fibroids in patients with symptomatic fibroids .
BACKGROUND	ClinicalTrials.gov ( www.clinicaltrials.gov ) registration numbers NCT01156857 ( PEARL III ) and NCT01252069 ( PEARL III extension ) .

###25645664
OBJECTIVE	To evaluate the prevalence of metabolic syndrome ( MetS ) and its association with physical capacity , disability , and self-rated health in older adults at high risk of mobility disability , including those with and without diabetes mellitus .
METHODS	Cross-sectional analysis .
METHODS	Lifestyle Interventions and Independence for Elders ( LIFE ) Study .
METHODS	Community-dwelling sedentary adults aged 70 to 89 at high risk of mobility disability ( Short Physical Performance Battery ( SPPB ) score 9 ; mean 7.4 1.6 ) ( N = 1,535 ) .
METHODS	Metabolic syndrome was defined according to the 2009 multiagency harmonized criteria ; outcomes were physical capacity ( 400-m walk time , grip strength , SPPB score ) , disability ( composite 19-item score ) , and self-rated health ( 5-point scale ranging from excellent to poor ) .
RESULTS	The prevalence of MetS was 49.8 % in the overall sample ( 83.2 % of those with diabetes mellitus , 38.1 % of those without ) .
RESULTS	MetS was associated with stronger grip strength ( mean difference ( ) = 1.2 kg , P = .01 ) in the overall sample and in participants without diabetes mellitus and with poorer self-rated health ( = 0.1 kg , P < .001 ) in the overall sample only .
RESULTS	No significant differences were found in 400-m walk time , SPPB score , or disability score between participants with and without MetS , in the overall sample or diabetes mellitus subgroups .
CONCLUSIONS	Metabolic dysfunction is highly prevalent in older adults at risk of mobility disability , yet consistent associations were not observed between MetS and walking speed , lower extremity function , or self-reported disability after adjusting for known and potential confounders .
CONCLUSIONS	Longitudinal studies are needed to investigate whether MetS accelerates declines in functional status in high-risk older adults and to inform clinical and public health interventions aimed at preventing or delaying disability in this group .

###24617226
OBJECTIVE	To verify the clinical efficacy on chronic fatigue syndrome of qi deficiency syndrome treated with acupuncture at selective time and explore the effect mechanism .
METHODS	Eighty patients were randomized into a selective-time-acupuncture group and an acupuncture group , 40 cases in each one .
METHODS	Qihai ( CV 6 ) , Guanyuan ( CV 4 ) , Hegu ( LI 4 ) , Taichong ( LR 3 ) , Sanyinjiao ( SP 6 ) and Zusanli ( ST 36 ) were selected in the two groups .
METHODS	In the selective-time-acupuncture group , acupuncture was used at 9:00 am to 11:00 am .
METHODS	In the acupuncture group , acupuncture was used at any time except in the range from 9:00 am to 11:00 am .
METHODS	No any manipulation was applied after the arrival of needling sensation .
METHODS	The treatment was given once every day , 10 day treatment made one session and two sessions of treatment were required .
METHODS	The fatigue scale was adopted to evaluate the efficacy before and after treatment in the patients of the two groups .
METHODS	The ratios among CD3 + , CD4 + and CD8 + T cells in the peripheral blood were detected before ad b a after treatment .
RESULTS	In the acupuncture group , the total score of fatigue and the score of physical fatigue were reduced after treatment as compared with those before treatment ( all P < 0.05 ) .
RESULTS	In the selective-time - acupuncture group , the total score of fatigue , the s core of physical fatigue and the score of mental fatigue after treatment were reduced obviously as compared with those hefore treatment ( all P < 0.01 ) .
RESULTS	The improvements in the scores of the selective-time-acupuncture group were superior to the acupuncture group ( all P < 0.05 ) .
RESULTS	The ratio of CD3 + and CD8 + T cells was increased obviously after treatment in the two groups ( all P < 0.05 ) and the ratio of CD4 + and CD8 + T cells was reduced obviously in the selective-time-acupuncture group ( P < 0.05 ) , which was better than that in the acupuncture group ( all P < 0.05 ) .
RESULTS	The total effective rate was 95.0 % ( 38/40 ) in the selective-time-acupuncture group , which was better than 80.0 % ( 32/40 ) in the acupuncture group ( P < 0.05 ) .
CONCLUSIONS	The acupuncture therapy at selective time is effective in the treatment of chronic fatigue syndrome of qi deficiency syndrome , which is especially better at relieving mental fatigue .
CONCLUSIONS	The effect of this therapy is achieved probably by improving the immune function via the regulation of the ratios among CD3 + , CD4 + and CD8 + T cells .

###26181091
OBJECTIVE	To understand whether using oral contraceptive pills ( OCPs ) results in temporary interruption of bleeding for etonogestrel contraceptive implant users during a 14-day course .
METHODS	In this double-blind trial , we randomly assigned etonogestrel implant users reporting 7 consecutive days or more of bothersome bleeding to receive 14 pills of study drug ( 150 microgram levonorgestrel and 30 microgram ethinyl estradiol combined OCPs ) or an identical-appearing placebo .
METHODS	The primary outcome was the proportion of women in each group who stopped bleeding during therapy and continued to report no bleeding at the end of therapy .
METHODS	Prespecified secondary outcomes were number of days until temporary interruption of bleeding occurred , number of days without bleeding during therapy , and number of days to recurrence of bleeding after discontinuation of therapy .
METHODS	We hypothesized that temporary interruption of bleeding would occur in 80 % of the treatment group compared with 20 % in the control group ; using 80 % power , we needed a sample size of 26 women .
METHODS	We performed intent-to-treat analysis .
RESULTS	From November 2013 through December 2014 , 66 women were screened and 32 were randomized : OCPs ( n = 16 ) or placebo ( n = 16 ) .
RESULTS	The majority was young , Caucasian women with reported bleeding as extremely or very annoying ; groups had similar baseline characteristics .
RESULTS	Participants randomized OCPs were more likely ( 14 of 16 [ 87.5 % 16.2 % ] compared with six of 16 [ 37.5 % 23.7 % ] ) to have a temporary interruption of bleeding during the study drug period ( odds ratio 11.7 , 95 % confidence interval 1.9-70 .2 ) .
RESULTS	Of women in the OCP arm who had a temporary interruption , 85.7 % had bleeding recurrence within 10 days after treatment .
CONCLUSIONS	Bothersome bleeding in etonogestrel contraceptive implant users will usually stop with 14-day OCP treatment , but bleeding most often resumes within days of treatment cessation .
BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT01968135 .
METHODS	I.

###24942930
OBJECTIVE	Examine longitudinal associations between sources of social support and social undermining for healthy eating and physical activity and weight change .
METHODS	Data are from 633 employed adults participating in a cluster-randomized multilevel weight gain prevention intervention .
METHODS	Primary predictors included social support and social undermining for two types of behaviors ( healthy eating and physical activity ) from three sources ( family , friends , and coworkers ) obtained via self-administered surveys .
METHODS	The primary outcome ( weight in kg ) was measured by trained staff .
METHODS	Data were collected at baseline , 12 months , and 24 months .
METHODS	Linear multivariable models examined the association of support and social undermining with weight over time , adjusting for intervention status , time , gender , age , education , and clustering of individuals within schools .
RESULTS	Adjusting for all primary predictors and covariates , friend support for healthy eating ( = -0.15 ) , coworker support for healthy eating ( = -0.11 ) , and family support for physical activity ( = -0.032 ) were associated with weight reduction at 24 months ( P-values < 0.05 ) .
RESULTS	Family social undermining for healthy eating was associated with weight gain at 24 months ( = 0.12 ; P = 0.0019 ) .
CONCLUSIONS	Among adult employees , friend and coworker support for healthy eating and family support for physical activity predicted improved weight management .
CONCLUSIONS	Interventions that help adults navigate family social undermining of healthy eating are warranted .

###24219882
OBJECTIVE	We assessed the impact of hot flashes and various forms of hormone therapy on health-related quality of life and sexual well-being in recently postmenopausal women .
METHODS	We prospectively interviewed 150 healthy women about hot flashes and health-related quality of life ( using the Women 's Health Questionnaire and the McCoy Female Sexuality Questionnaire ) , menopause-related symptoms , and general health .
METHODS	The women were classified into those with ( n = 72 ) and without ( n = 78 ) hot flashes and treated for 6 months with transdermal estradiol ( 1 mg/d ) , oral estradiol ( 2 mg/d ) with or without medroxyprogesterone acetate ( 5 mg/d ) , or placebo .
RESULTS	At baseline , hot flashes contributed most strongly to poor sleep ( correlation coefficient r = -0.525 , P < 0.0001 ) , somatic symptoms such as muscle pains ( r = -0.348 , P < 0.0001 ) , menstrual cycle-resembling complaints ( r = -0.304 , P < 0.0001 ) , anxiety and fears ( r = -0.283 , P < 0.0001 ) , decreased memory and concentration ( r = -0.279 , P = 0.001 ) , and sexual behavior ( r = -0.174 , P = 0.035 ) .
RESULTS	The different hormone therapy regimens alleviated hot flashes equally effectively and were therefore combined into a single group for further analysis .
RESULTS	In women with baseline flashes , hormone therapy use significantly improved the scores for sleep ( 0.787 [ 0.243 ] vs 0.557 [ 0.249 ] , hormone therapy vs placebo , P = 0.001 , at 6 mo ) , memory and concentration capacity ( 0.849 [ 0.228 ] vs 0.454 [ 0.301 ] , P < 0.0001 , at 6 mo ) , and anxiety and fears ( 0.942 [ 0.133 ] vs 0.826 [ 0.193 ] , P = 0.005 , at 6 mo ) .
RESULTS	Hormone therapy use showed no significant impact on these variables in women without baseline flashes .
CONCLUSIONS	Hot flashes contribute differently to various variables affecting health-related quality of life shortly after menopause .
CONCLUSIONS	Estradiol or an estradiol-medroxyprogesterone acetate combination similarly alleviates hot flashes and improves health-related quality of life in relation to elimination of hot flashes .
CONCLUSIONS	Hormone therapy use does not confer any detectable quality-of-life benefit over placebo in women without disturbing baseline flashes .

###24907876
BACKGROUND	A restricted sympathetic block during spinal anesthesia may minimize hemodynamic changes .
BACKGROUND	This prospective randomized study compared unilateral and bilateral spinal anesthesia with respect to the intra - and postoperative advantages and complications of each technique .
METHODS	Spinal anesthesia was induced with 0.5 % hyperbaric bupivacaine and a 25-G Quincke needle ( Dr. J ) in two groups of patients with physical status ASA I-II who had been admitted for orthopedic surgeries .
METHODS	In group A , dural puncture was performed with the patient in a seated position using 2.5 cm ( 3 ) of hyperbaric bupivacaine .
METHODS	Each patient was then placed in the supine position .
METHODS	In group B , dural puncture was performed with the patient in the lateral decubitus position with 1.5 cm ( 3 ) of hyperbaric bupivacaine .
METHODS	The lower limb was the target limb .
METHODS	The speed of injection was 1 mL/30s , and the duration of time spent in the lateral decubitus position was 20 min .
RESULTS	The demographic data were similar in both groups .
RESULTS	The time to the onset of the sensory and motor block was significantly shorter in group A ( p = 0.00 ) .
RESULTS	The duration of motor and sensory block was shorter in group B ( p < 0.05 ) .
RESULTS	The success rate for unilateral spinal anesthesia in group B was 94.45 % .
RESULTS	In two patients , the spinal block spread to the non-dependent side .
RESULTS	The incidence of complications ( nausea , headache , and hypotension ) was lower in group B ( p = 0.02 ) .
CONCLUSIONS	When unilateral spinal anesthesia was performed using a low-dose , low-volume and low-flow injection technique , it provides adequate sensory-motor block and helps to achieve stable hemodynamic parameters during orthopedic surgery on a lower limb .
CONCLUSIONS	Patients were more satisfied with this technique as opposed to the conventional approach .
CONCLUSIONS	Furthermore , this technique avoids unnecessary paralysis on the non-operated side .

###24886871
OBJECTIVE	This study aimed to establish the noninferiority of a single-freeze application with CO2 or N2O compared with the standard double freeze with N2O for cryotherapy treatment .
METHODS	Sixty women undergoing hysterectomy for reasons other than cervical cancer or precancer were randomized to 1 of 3 techniques as follows : ( 1 ) double freeze with N2O , ( 2 ) single freeze with N2O , or ( 3 ) single freeze with CO2 .
METHODS	The cervix was separated and cut into anterior and posterior segments , and the deepest area of necrosis was recorded .
METHODS	Comparisons were made using regression analysis .
METHODS	The margin of noninferiority was defined as 0.8 mm .
RESULTS	On the anterior lip , a single freeze with N2O was noninferior to a double freeze of the same gas , but on the posterior lip , the single freeze was not .
RESULTS	The single freeze of CO2 did not provide sufficient depth of necrosis in either lip to infer noninferiority versus the double freeze with N2O .
CONCLUSIONS	A single freeze with N2O is noninferior to a double-freeze technique in the anterior but not the posterior lip .
CONCLUSIONS	However , the result for posterior lips was close to reaching statistical significance .
CONCLUSIONS	In addition , CO2 had approximately 1 mm shallower depth of necrosis compared with N2O techniques ; however , the clinical implications are unknown .
CONCLUSIONS	Given the extensive use of CO2 globally , further clinical evaluation is needed .

###25166750
BACKGROUND	Vitamin D repletion with high doses of vitamin D is often recommended to patients and healthy subjects .
BACKGROUND	The safety , especially concerning changes in urinary calcium excretion is of great importance .
METHODS	In a double-blinded , placebo-controlled study in 40 healthy volunteers , we examined the changes in mineral metabolism during supplementation with 3000 IU of oral cholecalciferol daily during 4 months .
RESULTS	Both 25 ( OH ) vitamin D and 1,25 ( OH ) 2vitamin D increased significantly in the active treated group as compared to the placebo group ( 186 % versus 14 % ( P < 0.001 ) and 28 % versus -8 % ( P < 0.001 ) ) .
RESULTS	No change was observed in urinary calcium excretion in the active group compared to the placebo group ( P = 0.891 ) .
RESULTS	Fibroblast growth factor 23 increased significantly by 10 % ( P < 0.018 ) in the active group .
RESULTS	However , there was no difference in changes in FGF23 between treatment groups ( P = 0.457 ) .
CONCLUSIONS	High dose cholecalciferol significantly increases 25 ( OH ) vitamin D and 1,25 ( OH ) 2vitamin D levels compared to placebo .
CONCLUSIONS	No changes in urinary calcium excretion or other measured components of the mineral metabolism were found between groups .
BACKGROUND	ClinicalTrials.gov NCT00952562 .

###24289208
BACKGROUND	The present study analyses the relation between smoking status and the parameters used to assess vascular structure and function .
METHODS	This cross-sectional , multi-centre study involved a random sample of 1553 participants from the EVIDENT study .
METHODS	The smoking status , peripheral augmentation index and ankle-brachial index were measured in all participants .
METHODS	In a small subset of the main population ( 265 participants ) , the carotid intima-media thickness and pulse wave velocity were also measured .
RESULTS	After controlling for the effect of age , sex and other risk factors , present smokers have higher values of carotid intima-media thickness ( p = 0.011 ) .
RESULTS	Along the same lines , current smokers have higher values of pulse wave velocity and lower mean values of ankle-brachial index but without statistical significance in both cases .
CONCLUSIONS	Among the parameters of vascular structure and function analysed , only the IMT shows association with the smoking status , after adjusting for confounders .

###25443043
BACKGROUND	Children in Sub-Saharan Africa ( SSA ) are burdened by significant unmet mental health needs , but this region has limited access to mental health workers and resources to address these needs .
BACKGROUND	Despite the successes of numerous school-based interventions for promoting child mental health , most evidence-based interventions are not available in SSA .
BACKGROUND	This study will investigate the transportability of an evidence-based program from a developed country ( United States ) to a SSA country ( Uganda ) .
BACKGROUND	The approach includes task-shifting to early childhood teachers and consists of professional development ( five days ) to introduce strategies for effective behavior management and positive teacher-student interactions , and group-based consultation ( 14 sessions ) to support adoption of effective practices and tailoring to meet the needs of individual students .
METHODS	The design of this study is guided by two implementation frameworks , the Consolidated Framework for Implementation Research and the Teacher Training Implementation Model , that consider multidimensional aspects of intervention fidelity and contextual predictors that may influence implementation and teacher outcomes .
METHODS	Using a cluster randomized design , 10 schools in Uganda will be randomized to either the intervention group ( five schools ) or the waitlist control group ( five schools ) .
METHODS	A total of 80 to 100 early childhood teachers will be enrolled in the study .
METHODS	Teacher utilization of evidence-based strategies and practices will be assessed at baseline , immediate post-intervention ( six months after baseline ) , and at seven months post-intervention ( during a new academic year ) .
METHODS	Fidelity measures will be assessed throughout the program implementation period ( during professional development and consultation sessions ) .
METHODS	Individual teacher and contextual factors will be assessed at baseline .
METHODS	Data will be collected from multiple sources .
METHODS	Linear mixed-effect modeling , adjusting for school nesting , will be applied to address study questions .
CONCLUSIONS	The study will produce important information regarding the value of an evidence-based early intervention , and a theory-guided implementation process and tools designed for use in implementing early childhood evidence-based programs in SSA countries or resource-constrained community settings .
BACKGROUND	This trial was registered with ClinicalTrials.gov ( registration number : NCT097115 ) on 15 May 2013 .

###25226004
BACKGROUND	Soft-tissue augmentation with fillers is an aesthetic procedure for restoring age-related volume loss .
OBJECTIVE	To compare neocollagenesis and elastin production stimulated by Radiesse ( calcium hydroxylapatite ; CaHA , Merz Pharmaceuticals GmbH ) and a hyaluronic acid-based filler ( HA ; Juvderm VOLUMA ) .
METHODS	Twenty-four women , aged 35-45 , participated in this split-face , comparative study .
METHODS	Punch biopsies were taken 4 and 9 months after supraperiostal injection of each filler into the ipsilateral or contralateral postauricular area .
METHODS	Samples were analyzed for collagens type I and III , elastin , Ki-67 , and inflammatory and angiogenic markers .
RESULTS	At month 4 , collagen type III was greater with CaHA vs HA ( P = 0.0052 ) .
RESULTS	By month 9 , type I staining was higher with CaHA vs HA ( P = 0.0135 ) , whereas type III was lower with CaHA than HA ( P = 0.0019 ) .
RESULTS	Staining for elastin , Ki-67 and angiogenesis was greatest with CaHA at both timepoints .
RESULTS	Inflammatory markers increased most with HA treatment .
CONCLUSIONS	CaHA resulted in more active , physiologic remodeling of the extracellular matrix than HA by stimulating a two-step process whereby collagen type I gradually replaced type III .
CONCLUSIONS	Increased elastin stimulated by CaHA also indicates active remodeling .
CONCLUSIONS	The results of this study suggest that , in the first 9 months after treatment , by reconstituting tissue homeostasis without inducing inflammation suggests CaHA has more desirable characteristics for a dermal filler than HA .

###25440807
BACKGROUND	Experimental evidence suggests that the inhalational anesthetic sevoflurane has a cardioprotective effect .
BACKGROUND	Our objective was to determine if sedation with sevoflurane will reduce infarct size in patients with acute myocardial infarction ( MI ) who are treated with primary percutaneous coronary intervention ( PCI ) .
METHODS	We randomized 50 patients presenting with a first acute ST-elevation MI treated by primary PCI within 6 hours from symptom onset to sedation with sevoflurane inhalation or standard sedation ( control ) .
METHODS	Coronary flow at the end of PCI was assessed by corrected Thrombolysis In Myocardial Infarction frame count .
METHODS	Myocardial reperfusion was assessed by ST-segment resolution 60 minutes post-PCI .
METHODS	Infarct size was assessed by release of creatinine kinase ( CK ) and troponin T.
RESULTS	There was no difference in the primary end point : troponin T or CK release adjusted to the area at risk , between groups .
RESULTS	However , among patients with anterior MI , there was a trend toward lower CK ( P = .05 ) and nonsignificant decrease in troponin ( P = .11 ) levels in the sevoflurane group .
RESULTS	Corrected Thrombolysis In Myocardial Infarction frame count was 12.3 1.5 in the sevoflurane group and 15.6 9.1 in the control group ( P = .16 ) .
RESULTS	There was more ST resolution in patients treated by sevoflurane 80.7 % 25.8 % versus 56.6 % 35.7 % ( P = .01 ) .
RESULTS	Sevoflurane had no significant adverse effect during administration .
CONCLUSIONS	Sevoflurane administration during primary PCI did not reduce infarct size .
CONCLUSIONS	There was a trend toward a reduction in infarct size among patients with anterior MI .
CONCLUSIONS	Sevoflurane administration was associated with improvement in ST-segment resolution .

###24400937
OBJECTIVE	To compare a motivational intervention ( MI ) focused on increasing involvement in 12-Step groups ( TSGs ; e.g. Alcoholics Anonymous ) versus brief advice ( BA ) to attend TSGs .
METHODS	Patients were assigned randomly to either the MI or BA condition , and followed-up at 6 months after discharge .
METHODS	One hundred and forty substance use disorder ( SUD ) patients undergoing in-patient detoxification ( detox ) in Norway .
METHODS	The primary outcome was TSG affiliation measured with the Alcoholics Anonymous Affiliation Scale ( AAAS ) , which combines meeting attendance and TSG involvement .
METHODS	Substance use and problem severity were also measured .
RESULTS	At 6 months after treatment , compared with the BA group , the MI group had higher TSG affiliation [ 0.91 point higher AAAS score ; 95 % confidence interval ( CI ) = 0.04 to 1.78 ; P = 0.041 ] .
RESULTS	The MI group reported 3.5 fewer days of alcohol use ( 2.1 versus 5.6 days ; 95 % CI = -6.5 to -0.6 ; P = 0.020 ) and 4.0 fewer days of drug use ( 3.8 versus 7.8 days ; 95 % CI = -7.5 to -0.4 ; P = 0.028 ) ; however , abstinence rates and severity scores did not differ between conditions .
RESULTS	Analyses controlling for duration of in-patient treatment did not alter the results .
CONCLUSIONS	A motivational intervention in an in-patient detox ward was more successful than brief advice in terms of patient engagement in 12-Step groups and reduced substance use at 6 months after discharge .
CONCLUSIONS	There is a potential benefit of adding a maintenance-focused element to standard detox .

###25738178
OBJECTIVE	To compare epithelial connective tissue graft vs porcine collagen matrix for sealing postextraction sockets grafted with deproteinised bovine bone .
METHODS	A total of 30 patients , who needed a maxillary tooth to be extracted between their premolars and required a delayed , fixed , single implant-supported restoration , had their teeth atraumatically extracted and their sockets grafted with deproteinised bovine bone .
METHODS	Patients were randomised according to a parallel group design into two arms : socket sealing with epithelial connective tissue graft ( group A ) vs porcine collagen matrix ( group B ) .
METHODS	Outcome measures were : implant success and survival rate , complications , horizontal and vertical alveolar bone dimensional changes measured on Cone Beam computed tomography ( CBCT ) scans at three levels localised 1 , 3 , and 5 mm below the most coronal aspect of the bone crest ( levels A , B , and C ) ; and between the palatal and buccal wall peaks ( level D ) ; and peri-implant marginal bone level changes measured on periapical radiographs .
RESULTS	15 patients were randomised to group A and 15 to group B. No patients dropped out .
RESULTS	No failed implants or complications were reported 1 year after implant placement .
RESULTS	Five months after tooth extraction there were no statistically significant differences between the 2 groups for both horizontal and vertical alveolar bone dimensional changes .
RESULTS	At level A the difference was 0.13 0.18 ; 95 % CI 0.04 to 0.26 mm ( P = 0.34 ) , at level B it was 0.08 0.23 ; 95 % CI -0.14 to 0.14 ( P = 0.61 ) , at level C it was 0.05 0.25 ; 95 % CI -0.01 to 0.31 mm ( P = 0.55 ) and at level D it was 0.13 0.27 ; 95 % CI -0.02 to 0.32 mm ( P = 0.67 ) .
RESULTS	One year after implant placement there were no statistically significant differences between the 2 groups for peri-implant marginal bone level changes ( difference : 0.07 0.11 mm ; 95 % CI -0.02 to 0.16 ; P = 0.41 ) .
CONCLUSIONS	When teeth extractions were performed atraumatically and sockets were filled with deproteinised bovine bone , sealing the socket with a porcine collagen matrix or a epithelial connective tissue graft showed similar outcomes .
CONCLUSIONS	The use of porcine collagen matrix allowed simplification of treatment because no palatal donor site was involved .

###25152982
BACKGROUND	Standard treatment for patients with chronic hepatitis C genotype 1 ( CHC G-1 ) infection includes pegylated interferon plus ribavirin ( PEG-RBV ) for 48 weeks .
BACKGROUND	Shorter treatment regimen would be more acceptable due to lower cost and fewer side-effects .
BACKGROUND	We aimed to compare the efficacy of 36 week PEG-RBV therapy with standard 48 week therapy in CHC G-1 patients who achieve complete early virological response ( cEVR ) .
METHODS	Consecutive treatment-nave patients with CHC G-1 were treated with pegylated interferon a2b ( 1.5 g/kg/week ) or 2a ( 180 g/week ) and weight based ribavirin .
METHODS	Patients who achieved cEVR at 12 weeks [ undetectable HCV RNA irrespective of RVR ( rapid virological response ) ] were randomized into - group A ( 48 weeks therapy ) and group B ( 36 weeks therapy ) .
METHODS	Primary end-point was achievement of sustained virological response ( SVR ) at 24 weeks of follow up .
RESULTS	Out of the total 166 patients started on treatment , 112 ( 69.3 % ) achieved cEVR , and were randomized into group A ( n = 59 ) and group B ( n = 53 ) .
RESULTS	Fifty-five ( 93.2 % ) patients in group A and 50 ( 94.3 % ) in group B completed therapy .
RESULTS	The overall SVR rate in group A was 79.6 % ( 47/59 ) and group B was 84.9 % ( 45/53 ) ( p = 0.622 ) .
RESULTS	SVR rates in the two groups were comparable in all patient sub-groups according to factors like viral load ( or > 400,000 IU/mL ) , RVR ( achieved/not achieved ) , age ( or > 40 years ) , body mass index ( or > 27 ) and cirrhosis ( present/absent ) .
CONCLUSIONS	In CHC G-1 patients who achieve cEVR , 36 weeks PEG-RBV therapy is as effective as standard 48 weeks therapy , irrespective of other host or virological factors .

###25840296
OBJECTIVE	To compare the analgesic efficacy of 2 types of anesthetic techniques-topical and topical associated with cryoanalgesia-during cataract surgery .
METHODS	Department of Ophthalmology , University of So Paulo , Ribeiro Preto , Brazil .
METHODS	Prospective randomized study .
METHODS	Patients with symmetrical bilateral cataract had phacoemulsification with the use of an intraocular irrigation solution at room temperature in 1 eye and a cold ( 4C ) solution in the contralateral eye ( Group 2 ) .
METHODS	The pain related to the procedure was assessed using a visual analog scale ranging from 0 to 100 , with 0 representing no pain and 100 the worst pain .
METHODS	In addition , endothelial cell loss , the change in corneal thickness , and visual acuity were evaluated 30 days 2 ( SD ) after each surgery .
METHODS	The surgery duration , total irrigation volume , phacoemulsification time , and ultrasound power used were analyzed .
RESULTS	The study enrolled 25 patients ( 50 eyes ) .
RESULTS	There was no statistically significant difference in the mean pain score between Group 1 ( 26.0 3.7 ) and Group 2 ( 21.3 3.6 ) ( P = .2016 , paired t test ) .
RESULTS	No significant difference was found in the mean corneal endothelial cell loss ( Group 1 : 10.0 % 0.4 % ; Group 2 : 9.9 % 0.3 % ; P = .7576 ) , corneal thickness increase ( Group 1 : 1.5 1.0 m ; Group 2 : 1.4 0.9 m ; P = .9340 ) , or visual acuity gain ( Group 1 : 0.54 0.06 logMAR ; Group 2 : 0.55 0.09 logMAR ; P = .8208 ) .
CONCLUSIONS	There is no difference in the intensity of pain during phacoemulsification with the use of topical anesthesia or topical anesthesia associated with cryoanalgesia .
BACKGROUND	No author has a financial or proprietary interest in any material or method mentioned .

###24781054
OBJECTIVE	To assess the effectiveness of acupuncture combined with selective serotonin reuptake inhibitors ( SSRIs ) for patients with depression in hospital using a pragmatic randomised controlled trial .
METHODS	76 patients with depression were randomly divided into two groups ( randomisation ratio 2:1 for treatment and control groups ( CGs ) , respectively ) and 71 patients completed the study .
METHODS	The 45 patients in the treatment group ( TG ) underwent acupuncture and received an SSRI and the 26 patients in the CG received an SSRI only .
METHODS	The 17-item Hamilton Depression Rating Scale ( HDRS-17 ) was used to quantitatively assess patients after 1 , 2 , 4 and 6weeks of treatment .
RESULTS	The mean ( SD ) baseline total HDRS scores were 22.2 ( 0.60 ) and 22.1 ( 0.33 ) in the TG and CG , respectively .
RESULTS	After the first week of treatment the HDRS score for the TG was reduced to 15.6 ( 0.81 ) , significantly different from the score of 18.3 ( 0.55 ) for the CG , p < 0.05 .
RESULTS	This significant difference was maintained to the end of the 6-week treatment period , when HDRS scores had fallen to 6.3 ( 0.49 ) and 8.2 ( 0.35 ) for the TG and CG , respectively .
CONCLUSIONS	Acupuncture combined with an SSRI showed a statistically significant benefit for patients with depression in hospital over the 6-week period compared with SSRIs alone .
CONCLUSIONS	This reduction in symptoms started in the first week and continued throughout the 6weeks of treatment .

###25168620
OBJECTIVE	The aim of this study was to evaluate the population pharmacokinetics ( PK ) and exposure-response relationship of edoxaban in patients with non-valvular atrial fibrillation ( AF ) .
METHODS	Concentration data from 1,134 subjects in 11 clinical studies ( eight phase I , one phase II , and two phase III ) were used to perform a population PK analysis , including estimation of the bioavailability and quantification of the effects of P-glycoprotein ( P-gp ) inhibitors as well as renal impairment on edoxaban PK .
METHODS	The potential relationship between edoxaban PK exposure and incidence of bleeding events was explored based on data from 893 AF patients .
RESULTS	Absolute bioavailability of edoxaban was estimated as 58.3 % .
RESULTS	With oral dosing of edoxaban , co-administration of various P-gp inhibitors significantly increased edoxaban bioavailability and decreased volume of distribution ( V 2 ) , resulting in a predicted increase of 33-77 % in area under the curve ( AUC ) and 65-104 % in C max .
RESULTS	A much smaller increase was seen in edoxaban concentration at 24 h post-dose ( C 24 , -24 to 38 % ) , due to decreased V 2 and shortened elimination half-life .
RESULTS	With IV dosing of edoxaban , co-administration of the P-gp inhibitor quinidine decreased both edoxaban clearance ( CL ) and V 2 , resulting in an increase of 32 % in AUC and 66 % in C 24 .
RESULTS	Creatinine clearance was a significant covariate on renal clearance , whereas age and body weight significantly affected nonrenal clearance .
RESULTS	Model-predicted steady state C min was slightly higher , but AUC was comparable for patients who had severe renal impairment and received edoxaban 15 mg once daily ( QD ) versus patients who had normal renal function or mild renal impairment and received edoxaban 30 mg QD .
RESULTS	Exposure-response analysis suggested that edoxaban C min and country/region are significantly associated with the incidence of bleeds .
CONCLUSIONS	The model provided reasonable estimation with regard to the absolute bioavailability of edoxaban , the magnitude of change in edoxaban exposure upon co-administration of P-gp inhibitors , and the impact of renal impairment on edoxaban clearance .
CONCLUSIONS	Analysis results supported a 50 % dose reduction scheme for subjects with severe renal impairment .
CONCLUSIONS	Further confirmation will be sought by incorporating clinical safety and efficacy information from larger phase III trials .

###25463413
BACKGROUND	We sought to determine if outcomes with exercise training in heart failure ( HF ) vary according to ventricular pacing type .
RESULTS	Heart Failure : A Controlled Trial Investigating Outcomes of Exercise Training ( HF-ACTION ) randomized 2,331 outpatients with HF and left ventricular ejection fraction 35 % to usual care plus exercise training or usual care alone .
RESULTS	We examined the relationship between outcomes and randomized treatment according to ventricular pacing status with the use of Cox proportional hazards modeling .
RESULTS	In HF-ACTION 1,118 patients ( 48 % ) had an implanted cardiac rhythm device : 683 with right ventricular ( RV ) and 435 with biventricular ( BiV ) pacemakers .
RESULTS	Patients with pacing devices were older , more frequently white , and had lower peak VO2 ( P < .001 for all ) .
RESULTS	Peak VO2 improved similarly with training in groups with and without pacing devices .
RESULTS	The primary composite end point-all-cause death or hospitalization-was reduced only in patients randomized to exercise training without a device ( hazard ratio [ HR ] 0.79 , 95 % confidence interval [ CI ] 0.67-0 .93 [ P = .004 ] ; RV lead : HR 1.04 , 95 % CI 0.84-1 .28 [ P = .74 ] ; BiV pacing : HR 1.05 , 95 % CI 0.82-1 .34 [ P = .72 ] ; interaction P = .058 ) .
CONCLUSIONS	Exercise training may improve exercise capacity in patients with implanted cardiac devices .
CONCLUSIONS	However , the apparent beneficial effects of exercise on hospitalization or death may be attenuated in patients with implanted cardiac devices and requires further study .

###24935932
OBJECTIVE	Inhibition of dipeptidyl peptidase 4 ( DPP4 ) is thought to intensify the physiological effects of the incretin hormones .
OBJECTIVE	We investigated the effects of DPP4 inhibition on plasma levels of glucose-dependent insulinotropic polypeptide ( GIP ) , glucagon-like peptide 1 ( GLP1 ) , incretin effect , glucose tolerance , gastrointestinal-mediated glucose disposal ( GIGD ) and gastric emptying in healthy subjects .
METHODS	A randomised , controlled and open-labelled study .
METHODS	Ten healthy subjects ( six women ; age , 405 years ( means.e.m . )
METHODS	; BMI , 243kg/m ( 2 ) ; fasting plasma glucose , 5.10.2 mmol/l and HbA1c , 341mmol/mol ( 5.30.1 % ) ) were randomised to two-paired study days comprising a 4-h 50g oral glucose tolerance test ( OGTT ) with paracetamol ( A ) and an isoglycaemic intravenous ( i.v. ) glucose infusion ( B ) , with ( A1 + B1 ) and without ( A2 + B2 ) preceding administration of the DPP4 inhibitor sitagliptin .
RESULTS	Isoglycaemia was obtained in all subjects on the paired study days .
RESULTS	Significant increases in fasting levels and OGTT-induced responses of active GLP1 and GIP were seen after DPP4 inhibition .
RESULTS	No significant impact of DPP4 inhibition on fasting plasma glucose ( 5.10.1 vs 4.90.1 mmol/l , P = 0.3 ) , glucose tolerance ( area under the curve ( AUC ) for plasma glucose , 15135 vs 13726mmol/lmin , P = 0.7 ) or peak plasma glucose during OGTT ( 8.50.4 vs 8.10.3 mmol/l , P = 0.3 ) was observed .
RESULTS	Neither incretin effect ( 409 % ( without DPP4 inhibitor ) vs 407 % ( with DPP4 inhibitor ) , P = 1.0 ) , glucagon responses ( 1395165 vs 1223195pmol/lmin , P = 0.41 ) , GIGD ( 524 vs 565 % , P = 0.40 ) nor gastric emptying ( Tmax for plasma paracetamol : 869 vs 8012min , P = 0.60 ) changed following DPP4 inhibition .
CONCLUSIONS	These results suggest that acute increases in active incretin hormone levels do not affect glucose tolerance , GIGD , incretin effect , glucagon responses or gastric emptying in healthy subjects .

###24472479
OBJECTIVE	Patients 65 years old ( `` older '' ) are often not included in randomized clinical trials ( RCT ) , but when they are , care in an RCT might improve quality of life ( QoL ) .
OBJECTIVE	We conducted a prospective comparison of QoL among older women receiving standard chemotherapy from the same cooperative group physicians in an RCT vs. an observational study ( `` off-trial '' ) .
METHODS	Older women with invasive , non-metastatic breast cancer ( n = 150 RCT ; 530 off-trial ) were included .
METHODS	Linear mixed-effects models tested associations between chemotherapy on - vs. off-trial and changes in EORTC ( European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire ) QoL scores over 24 months , controlling for pre-treatment QoL , age , education , tumor factors , comorbidity , and other covariates .
RESULTS	Anthracycline regimens were used by 58 % of women treated on-trial vs. 54 % of those treated off-trial .
RESULTS	Women in the RCT reported an adjusted mean increase of 13.7 points ( 95 % CI 10.2 , 17.1 ) in global QoL at 24 months ( vs. mid-treatment ) , while women treated off-trial had only an adjusted improvement of 7.0 points ( 95 % CI 3.5 , 10.4 ; p = .007 for difference in mean changes ) .
RESULTS	Women in the RCT had significantly greater improvement in emotional function than those treated off-trial , controlling for baseline ; they also had greater reductions in therapy side effects and fatigue at 24 months than women off-trial , controlling for covariates .
CONCLUSIONS	There may be different QoL trajectories for older women undergoing breast cancer chemotherapy on - vs. off-trial .
CONCLUSIONS	If confirmed , the results suggest that the extra monitoring and communication within an RCT could provide the infrastructure for interventions to address symptoms and improve QoL for the growing older cancer population .

###24656287
BACKGROUND	Acute cellular rejection ( AR ) after lung transplantation may result in significant morbidity and mortality both on the short and long term .
BACKGROUND	Transbronchial biopsy through flexible bronchoscopy is highly sensitive for the diagnosis of AR , but reproducibility of histopathologic interpretation is less convincing .
BACKGROUND	Probe-based confocal laser endomicroscopy ( pCLE ) , a novel imaging tool in the field of respiratory medicine , enables real-time imaging of the pulmonary acini .
METHODS	We performed 105 bronchoscopies in lung transplant recipients , combining both transbronchial biopsies and pCLE .
METHODS	We conducted an observational survey for pCLE findings in AR .
RESULTS	Calculations for cellularity showed a median cell count ( ACA ) of 50 ( IQR 18 to 120 ) cells per microscopic field for AR and 10 ( IQR 0 to 15 ) cells per microscopic field for matched controls ( p = 0.0004 ) .
RESULTS	Cellular autofluorescence in the AR group was 1,163 ( 157 ) units and 489 ( 101 ) units for the matched controls ( p = 0.0009 ) .
RESULTS	Autofluorescent cells were present in 73 % ( 10 ) of the recorded frames in the AR group and in only 42 % ( 9 ) of the recorded frames in the control group ( p = 0.03 ) .
RESULTS	Contingency analysis for the presence/absence of ACA in the AR group versus the control group showed a sensitivity of 0.93 and a specificity of 0.46 ( relative risk = 6.5 [ 95 % CI 0.94 to 44.8 ] , p = 0.01 ) .
RESULTS	The consecutive application of 3 pCLE criteria resulted in a sensitivity of 0.93 and a specificity of 0.83 for detection of AR .
CONCLUSIONS	Our observational survey suggests the existence of specific pCLE characteristics in patients with AR .
CONCLUSIONS	Further efforts are necessary to validate these findings prospectively .

###24253285
BACKGROUND	Noroviruses are the most common cause of gastroenteritis in the United States .
BACKGROUND	An understanding of the infectious dose of these viruses is important for risk assessment studies .
METHODS	Healthy adults were enrolled in a randomized , double-blind , placebo-controlled evaluation of different dosages of Norwalk virus .
METHODS	Eligible subjects were monitored for clinical gastroenteritis , and infection status was determined .
METHODS	The presence of virus in vomitus was also assessed .
RESULTS	Fifty-seven persons were enrolled ; 8 received placebo and an additional 8 persons were considered to be nonsusceptible on the basis of being secretor negative .
RESULTS	Twenty-one persons were infected ( all blood group O or A ) , and 67 % of those infected developed viral gastroenteritis .
RESULTS	The 50 % human infectious dose was calculated to be 3.3 reverse transcription polymerase chain reaction units ( approximately 1320 genomic equivalents [ gEq ] ) for secretor-positive blood group O or A persons and 7.0 ( approximately 2800 gEq ) for all secretor-positive persons .
RESULTS	The time of illness onset was inversely correlated with inoculum dose .
RESULTS	The maximal concentration of virus shedding was higher for persons with gastroenteritis .
RESULTS	Norwalk virus was identified in 15 of 27 ( 56 % ) vomitus samples at a median concentration of 41 000 gEq/mL .
CONCLUSIONS	The 50 % human infectious dose measured is higher than previous estimates and similar to that of other RNA viruses .
CONCLUSIONS	Clinical Trials RegistrationNCT00138476 .

###25940250
BACKGROUND	Hospital readmissions for acute exacerbations of COPD ( AECOPDs ) pose burdens to the health-care system and patients .
BACKGROUND	A current gap in knowledge is whether a predischarge screening and educational tool administered to patients with COPD reduces readmissions and ED visits .
METHODS	A single-center , randomized trial of admitted patients with AECOPDs was conducted at Henry Ford Hospital between February 2010 and April 2013 .
METHODS	One hundred seventy-two patients were randomized to either the control ( standard care ) or the bundle group in which patients received smoking cessation counseling , screening for gastroesophageal reflux disease and depression or anxiety , standardized inhaler education , and a 48-h postdischarge telephone call .
METHODS	The primary end point was the difference in the composite risk of hospitalizations or ED visits for AECOPD between the two groups in the 30 days following discharge .
METHODS	A secondary end point was 90-day readmission rate .
RESULTS	Of the 172 patients , 18 of 79 in the control group ( 22.78 % ) and 18 of 93 in the bundle group ( 19.35 % ) were readmitted within 30 days .
RESULTS	The risk of ED visits or hospitalizations within 30 days was not different between the groups ( risk difference , -3.43 % ; 95 % CI , -15.68 % to 8.82 % ; P = .58 ) .
RESULTS	Overall , the time to readmission in 30 and 90 days was similar between groups ( log-rank test P = .71 and .88 , respectively ) .
CONCLUSIONS	A predischarge bundle intervention in AECOPD is not sufficient to reduce the 30-day risk of hospitalizations or ED visits .
CONCLUSIONS	More resources may be needed to generate a measurable effect on readmission rates .
BACKGROUND	ClinicalTrials.gov ; No. : NCT02135744 ; URL : www.clinicaltrials.gov .

###24896818
BACKGROUND	Opioid-induced constipation is common and debilitating .
BACKGROUND	We investigated the efficacy and safety of naloxegol , an oral , peripherally acting , - opioid receptor antagonist , for the treatment of opioid-induced constipation .
METHODS	In two identical phase 3 , double-blind studies ( study 04 , 652 participants ; study 05 , 700 participants ) , outpatients with noncancer pain and opioid-induced constipation were randomly assigned to receive a daily dose of 12.5 or 25 mg of naloxegol or placebo .
METHODS	The primary end point was the 12-week response rate ( 3 spontaneous bowel movements per week and an increase from baseline of 1 spontaneous bowel movements for 9 of 12 weeks and for 3 of the final 4 weeks ) in the intention-to-treat population .
METHODS	The key secondary end points were the response rate in the subpopulation of patients with an inadequate response to laxatives before enrollment , time to first postdose spontaneous bowel movement , and mean number of days per week with one or more spontaneous bowel movements .
RESULTS	Response rates were significantly higher with 25 mg of naloxegol than with placebo ( intention-to-treat population : study 04 , 44.4 % vs. 29.4 % , P = 0.001 ; study 05 , 39.7 % vs. 29.3 % , P = 0.02 ; patients with an inadequate response to laxatives : study 04 , 48.7 % vs. 28.8 % , P = 0.002 ; study 05 , 46.8 % vs. 31.4 % , P = 0.01 ) ; in study 04 , response rates were also higher in the group treated with 12.5 mg of naloxegol ( intention-to-treat population , 40.8 % vs. 29.4 % , P = 0.02 ; patients with an inadequate response to laxatives , 42.6 % vs. 28.8 % , P = 0.03 ) .
RESULTS	A shorter time to the first postdose spontaneous bowel movement and a higher mean number of days per week with one or more spontaneous bowel movements were observed with 25 mg of naloxegol versus placebo in both studies ( P < 0.001 ) and with 12.5 mg of naloxegol in study 04 ( P < 0.001 ) .
RESULTS	Pain scores and daily opioid dose were similar among the three groups .
RESULTS	Adverse events ( primarily gastrointestinal ) occurred most frequently in the groups treated with 25 mg of naloxegol .
CONCLUSIONS	Treatment with naloxegol , as compared with placebo , resulted in a significantly higher rate of treatment response , without reducing opioid-mediated analgesia .
CONCLUSIONS	( Funded by AstraZeneca ; KODIAC-04 and KODIAC-05 ClinicalTrials.gov numbers , NCT01309841 and NCT01323790 , respectively . )

###24797760
BACKGROUND	Patients with a pacing indication and first-degree atrioventricular ( AV ) - block pose a clinical challenge .
BACKGROUND	The prognostic impact of first-degree AV-block in patients with sinus node dysfunction and the impact of pacing in this setting are not known .
METHODS	In the Mode Selection Trial ( MOST ) , 2,010 patients with sinus node dysfunction were randomized to either dual-chamber ( DDD-R ) or ventricular ( VVI-R ) pacing and followed for a median of 33 months .
METHODS	We report on clinical outcomes in patients with first-degree AV-block ( PR interval > 200 ms ) compared with patients who had a normal PR interval at baseline .
RESULTS	Patients with first-degree AV-block ( n = 378 ) were older ( median [ Q1 , Q3 ] ; 76 [ 70 , 82 ] years vs 73 [ 66 , 79 ] years , P < 0.0001 ) , more often male ( 57 % vs 49 % , P = 0.0049 ) , and had more comorbidity , such as hypertension ( 66 % vs 60 % , P = 0.034 ) and heart failure ( 24 % vs 17 % , P = 0.0050 ) than patients with normal AV-conduction ( n = 1,159 ) .
RESULTS	In multivariable analyses , patients with first-degree AV-block were at greater risk of death , stroke , or heart failure hospitalization ( hazard ratio [ HR ] 1.31 , 95 % confidence interval [ CI ] 1.06-1 .61 , P = 0.013 ) .
RESULTS	A trend towards a higher incidence of atrial fibrillation was seen ( HR 1.24 , 95 % CI 0.98-1 .55 , P = 0.069 ) .
RESULTS	No significant interactions between pacing arm and prolonged versus normal PR were found for any endpoint , and hazard ratios were consistent across subgroups .
CONCLUSIONS	First-degree AV-block is associated with more advanced disease but is still an independent predictor of poor clinical outcome .
CONCLUSIONS	Neither DDD-R nor VVI-R pacing , as employed in MOST , eliminate the negative effects associated with first-degree AV-block .

###24275098
BACKGROUND	This study evaluated the pharmacokinetics of a granule formulation of dolutegravir developed as an alternative to tablets for use in paediatric populations .
METHODS	A randomized , open-label study in healthy adults was carried out .
METHODS	Subjects received five treatments in a crossover design : a single dose of dolutegravir 50 mg as a tablet and dolutegravir 50 mg in 10 g of granule administered directly to mouth or mixed with purified water , water containing high cation concentrations or milk-based infant formula .
METHODS	Study treatments were separated by 7 days .
METHODS	Safety evaluations and serial pharmacokinetic sampling were done during each treatment period .
METHODS	A non-compartmental pharmacokinetic analysis was performed ; geometric least-squares mean ratios and 90 % CIs were generated for treatment comparison .
METHODS	Palatability was assessed by questionnaire .
RESULTS	Plasma dolutegravir exposures in all granule treatment arms exceeded those of tablet formulation .
RESULTS	The mean area under the curve from time 0 to infinity ( AUC ( 0 - ) ) and maximum concentrations were 55-83 % and 62-102 % higher , respectively .
RESULTS	Pharmacokinetics were similar when dolutegravir was mixed with purified or cation-containing water .
RESULTS	Dolutegravir was well tolerated , with no withdrawals due to adverse events .
RESULTS	Taste was rated acceptable for all treatments .
CONCLUSIONS	The exposure of dolutegravir after administration of granule formulation alone , with different types of water and with milk formula , exceeded that of the tablet .
CONCLUSIONS	The similarity of dolutegravir exposure seen with the granule formulation demonstrates that dolutegravir granule can be given without restriction on the type of liquid or can be administered directly to the mouth ( for example , when potable water is not available ) .

###25948400
OBJECTIVE	To establish during late gestation and early lactation the effects of supplementing silymarin , a natural hepatoprotective substance , combined with a powerful antioxidant , lycopene , on milk production and on serum biomarkers of oxidative status .
METHODS	Italian Friesian dairy cows were given individually a supplement containing a mixture of silymarin ( 7.77 g/day/cow ) and lycopene ( 1.27 g/day/cow ) ( n = 10 ) or no supplement ( control ; n = 10 ) .
METHODS	Treatment was administered from 7 days before the expected calving date to the first 14 days in milk .
METHODS	At 7 days before the expected calving date , at calving , and 7 days postpartum , body condition score ( BCS ) and concentrations in serum of reactive oxygen metabolites ( ROM ) , total antioxidant capacity ( OXY ) and thiobarbituric acid reactive substances ( TBARS ) were evaluated .
METHODS	Bodyweight , milk production , and somatic cell count ( SCC ) were determined at 7 , 14 and 21 days postpartum .
RESULTS	The mean time of treatment prior to calving was 6.3 ( min 4 , max 11 ) days .
RESULTS	Compared with control cows , treatment increased energy corrected milk yield ( 33.3 vs. 37.8 ( SEM 1.10 ) kg/day ; p = 0.006 ) and milk fat yield ( 1.14 vs. 1.32 ( SEM 0.06 ) kg/day ; p = 0.05 ) over the first 21 days of lactation .
RESULTS	Treated cows had lower mean log10 SCC compared to control cows ( 4.9 vs. 5.24 ( SEM 0.11 ) log10 cells/mL ) and had lower overall concentration of TBARS ( 1.47 vs. 1.59 ( SEM 0.016 ) nM/mL ; p < 0.001 ) , but similar concentrations of ROM and OXY in serum .
RESULTS	However there was a treatment by time interaction ( p = 0.09 ) for OXY , and at calving mean OXY was higher in treated cows compared with pre-calving values ( p < 0.001 ) .
CONCLUSIONS	Despite the acknowledged limitation of the study , i.e. the small number of animals , our results suggest that silymarin and lycopene , as health-beneficial feed supplements , may help dairy cows in metabolic adaptation during the first stages of lactation .
CONCLUSIONS	During the peripartum period dairy cows suffer moderate-to-severe fatty liver and from an overproduction of free radicals .
CONCLUSIONS	The supplementation of a mixture of silymarin and lycopene during these stressful days may be useful to mitigate these metabolic disorders with beneficial effects on the subsequent lactation .

###24964913
OBJECTIVE	Part 1 of this phase III study was a randomized , double-blind , parallel-group , placebo-controlled , multicenter study of caregiver administered diazepam auto-injector ( AI ) in subjects with acute repetitive seizures ( ARS ) and demonstrated that diazepam AI was well-tolerated and significantly more effective than placebo AI in delaying the time to next seizure or rescue .
OBJECTIVE	Part 2 of this study , presented herein , was an open-label continuation to assess the long-term safety and effectiveness of diazepam AI for the treatment of ARS .
METHODS	Of the 234 subjects randomized in part 1 , 161 continued into part 2 and were provided open-label diazepam AI .
METHODS	Effectiveness measures were time to next seizure or rescue , number of subsequent rescues by type ( rescue medication , emergency room visit , or other medical care ) , and number of subsequent seizures during the 12-h follow-up period .
METHODS	Safety data ( adverse events and respirations < 8/min ) were also collected .
RESULTS	During the open-label part 2 study , 129 subjects were administered a total of 1,380 diazepam AI treatments ( median 4.5 ; range 1-118 ) , of which 1,071 ( 77.6 % ) were effective with no subsequent seizure or rescue during the 12-h follow-up period .
RESULTS	Median number of subsequent seizures experienced by subjects was one ( range 0-20 ) .
RESULTS	Of the 1,380 administrations , 79 ( 5.7 % ) required use of rescue medication , 18 ( 1.3 % ) required a visit to an emergency room , and 6 ( 0.4 % ) required other rescue medical care .
RESULTS	In most ( 75 % ) of subjects with treatment-emergent adverse events ( TEAEs ) , TEAEs were mild or moderate in severity .
RESULTS	Commonly reported treatment-related TEAEs were injection-site pain ( 10.9 % ) , injection-site hemorrhage ( 7 % ) , and injection-site bruising ( 6.3 % ) .
RESULTS	Although three subjects met the predefined respiratory rate threshold , none were considered clinically significant or reported as AEs .
CONCLUSIONS	Long-term treatment with diazepam AI administered by trained caregivers in an outpatient setting to treat ARS is a safe and effective option .
CONCLUSIONS	A PowerPoint slide summarizing this article is available for download in the Supporting Information section here .

###25378675
OBJECTIVE	The prognostic importance of the speed of early hematoma growth in acute intracerebral hemorrhage ( ICH ) has not been well established .
OBJECTIVE	We aimed to determine the association between the rate of increase in hematoma volume and major clinical outcomes in the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial ( INTERACT ) studies .
OBJECTIVE	The effects of early intensive blood pressure ( BP ) lowering according to the speed of hematoma growth were also investigated .
METHODS	Pooled analyses of the INTERACT1 ( n = 404 ) and INTERACT2 ( n = 2,839 ) studies-randomized controlled trials of patients with spontaneous ICH with elevated systolic BP , randomly assigned to intensive ( target systolic BP < 140 mm Hg ) or guideline-based ( < 180 mm Hg ) BP management .
METHODS	The speed of ultraearly hematoma growth ( UHG ) was defined as hematoma volume ( mL ) / onset-to-CT time ( hours ) .
METHODS	Primary outcome was death or major disability ( modified Rankin Scale score of 3-6 ) at 90 days .
RESULTS	Among a total of 2,909 patients ( 90 % ) with information on UHG and outcome , median speed of UHG was 6.2 mL/h .
RESULTS	There was a linear association between UHG and outcome : multivariable-adjusted odd ratios 1.90 ( 95 % confidence interval 1.50-2 .39 ) for 5-10 mL/h and 2.96 ( 2.36-3 .71 ) for > 10 mL/h vs the < 5 mL/h group .
RESULTS	There were no clear differences in the effects of intensive BP lowering according to 3 speeds of UHG on outcome ( p = 0.75 for homogeneity ) .
CONCLUSIONS	The speed of UHG in patients with ICH was continuously associated with increased risks of death or major disability , and from lower levels than previously reported ( 5 mL/h ) .
CONCLUSIONS	The benefits of intensive BP lowering appear to be independent of the speed of bleeding .

###25449153
BACKGROUND	Photodynamic therapy is an effective tool in the management of some forms of skin cancer and generalized solar dermopathy and can be beneficial in the management of acne vulgaris .
BACKGROUND	When used as an area treatment one of the main limiters is the quite severe burning pain that patients feel during the illumination phase of the treatment .
OBJECTIVE	To examine the effectiveness of a plant derived anti-nociceptive spray applied prior to and during large area photodynamic therapy .
METHODS	A split face or left arm versus right arm , placebo controlled trial was performed on 60 patients to assess the effectiveness of the spray in reducing pain perception .
RESULTS	There was a statistically significant reduction in pain at all illumination points during the illumination phase but no significant difference in discomfort levels in the first 72 h post illumination .
CONCLUSIONS	Only large area photodynamic therapy treatment was performed during the study .
CONCLUSIONS	No conclusions can be drawn for small area treatments .
CONCLUSIONS	Use of a simple , plant derived anti-nociceptive spray can reduce the discomfort experienced by patients undergoing photodynamic therapy to large areas .

###24397123
OBJECTIVE	To compare the effectiveness of the traditional center of tibial plateau as the entry point and digital technology in the design of intramedullary tibial nail point positioning method in total knee arthroplasty ( TKA ) .
METHODS	Between October 2011 and October 2012 , 60 cases undergoing unilateral TKA and meeting the selection criteria were randomly divided into 2 groups : in group A ( 30 cases ) , the tibial plateau center as the entry point of tibial intramedullary positioning was used ; in group B ( 30 cases ) , Mimics 10.01 software to simulate the guide rod point of tibial intramedullary positioning was used .
METHODS	There was no significant difference in gender , age , etiology , disease duration , sides , and preoperative knee range of motion , Hospital for Special Surgery ( HSS ) score , and Western Ontario and McMaster University Osteoarthritis Index ( WOMAC ) between 2 groups ( P > 0.05 ) .
METHODS	Postoperative X-ray films were taken to measure the tibiofemoral angle and tibial angle ; knee range of motion , and HSS and WOMAC scores were used to assess the activity of knee .
RESULTS	The entry point of group B was located in front of the center of tibial plateau , which was inconsistent with the traditional entry point .
RESULTS	The incision healed by first intention in all patients of 2 groups .
RESULTS	The patients were followed up 6 to 12 months ( mean , 8.6 months ) .
RESULTS	The X-ray measurement at 1 week after operation showed no significant difference in tibiofemoral angle between 2 groups ( t = -6.65 , P = 0.72 ) , but the anteroposterior and lateral tibial angles of group A were significantly lower than those of group B ( P < 0.05 ) .
RESULTS	The knee range of motion , HSS score , and WOMAC score of 2 groups were significantly higher at 3 and 6 months after operation when compared with preoperative values ( P < 0.05 ) , and the values at 6 months were significantly increased than those at 3 months after operation ( P < 0.05 ) .
RESULTS	HSS score and WOMAC score had no significant difference between 2 groups at 3 months after operation ( P > 0.05 ) , but the scores of group B were significantly higher than those of group A at 6 months ( P < 0.05 ) .
RESULTS	The knee range of motion of group B was significantly better than that of group A at 3 months after operation ( t = 2.13 , P = 0.04 ) , but no significant difference was found between 2 groups at 6 months ( t = 0.58 , P = 0.56 ) .
CONCLUSIONS	Compared with the traditional intramedullary guide rod insertion point positioning , digital individualized design of entry point positioning has the advantages of more accurate lower limb force line , better recovery of knee function , and earlier 90 degrees activities , but the long-term effectiveness needs further observation .

###24221533
BACKGROUND	Chronic alcohol abuse has been traditionally associated with impaired cognitive abilities .
BACKGROUND	The deficits are most evident in higher order cognitive functions , such as abstract reasoning , problem solving and visuospatial processing .
BACKGROUND	The present study sought to increase current understanding of the neuropsychological basis of poor abstract reasoning abilities in alcohol-dependent subjects using functional magnetic resonance imaging ( fMRI ) .
METHODS	An abstract reasoning task-based fMRI study was carried out on alcohol-dependent subjects ( n = 18 ) and healthy controls ( n = 18 ) to examine neural activation pattern .
METHODS	The study was carried out using a 3-T whole-body magnetic resonance scanner .
METHODS	Preprocessing and post processing was performed using SPM 8 software .
RESULTS	Behavioral data indicated that alcohol-dependent subjects took more time than controls for performing the task but there was no significant difference in their response accuracy .
RESULTS	Analysis of the fMRI data indicated that for solving abstract reasoning-based problems , alcohol-dependent subjects showed enhanced right frontoparietal neural activation involving inferior frontal gyrus , post central gyrus , superior parietal lobule , and occipito-temporal gyrus .
CONCLUSIONS	The extensive activation observed in alcohol dependents as compared to controls suggests that alcohol dependents recruit additional brain areas to meet the behavioral demands for equivalent task performance .
CONCLUSIONS	The results are consistent with previous fMRI studies suggesting decreased neural efficiency of relevant brain networks or compensatory mechanisms for the execution of task for showing an equivalent performance .

###25607552
OBJECTIVE	To evaluate efficacy , safety , and tolerability efinaconazole topical solution , 10 % in diabetic patients with onychomycosis .
METHODS	A post-hoc analysis of 112 patients , aged 29-70 years , randomized to receive efinaconazole topical solution , 10 % or vehicle from two identical multicenter , double-blind , vehicle-controlled 48-week studies evaluating safety and efficacy .
METHODS	The primary end point was complete cure rate ( 0 % clinical involvement of target toenail , and both negative potassium hydroxide examination and fungal culture ) at week 52 .
RESULTS	Mycologic cure rates ( OC ) were significantly greater with efinaconazole ( 56.5 % and 56.3 % in diabetic and non-diabetic patients respectively ) compared to vehicle ( P = 0.016 and P < 0.001 , respectively ) .
RESULTS	The primary end point , complete cure , was also greater for efinaconazole ( 13.0 % and 18.8 % , respectively vs 3.7 % and 4.7 % ) .
RESULTS	Treatment success ( percent affected target toenail 10 % ) for efinaconazole was 40.8 % and 47.7 % , respectively vs 18.5 % and 18.2 % with vehicle .
RESULTS	There was no statistically significant difference between the diabetic and non-diabetic populations for any efficacy endpoint .
RESULTS	Adverse events associated with efinaconazole were local site reactions and clinically similar to vehicle .
CONCLUSIONS	Once daily efinaconazole topical solution , 10 % may provide a useful topical option in the treatment of diabetic patients with onychomycosis .

###24986270
BACKGROUND	Allergic rhinitis is a chronic illness , affecting 10 to 40 % of the worldwide population .
BACKGROUND	Chinese herbal medicines , the treatment of allergic rhinitis , adopted thousands of years in ancient China , has recently raised much attention among researchers globally .
BACKGROUND	This study evaluates the effects of two Chinese herbal formulae [ Cure-allergic-rhinitis Syrup ( CS ) and Yu-ping-feng San ( YS ) ] in treating undergraduate nursing students with allergic rhinitis over a 3-month follow-up , when compared to a placebo control group .
METHODS	A double-blind , randomised controlled trial with repeated-measures , three-parallel-groups design was conducted in a random sample of 249 participants recruited from one university in Hong Kong .
METHODS	After baseline measurements , participants were randomly assigned to CS , YS , or placebo groups ( n = 83 per group ) .
METHODS	The main outcomes , including symptom severity , quality of life , and body constitution , were measured with self-administered questionnaires at baseline and immediately , 1 and 3 months after the 4-week interventions .
RESULTS	240 participants completed the trial , with 9 ( 3.6 % ) drop-outs .
RESULTS	The results of Generalised Estimating Equations test followed by pairwise contrasts tests indicated that the participants who received CS showed significantly greater reduction of symptoms ( mean difference of CS vs. placebo = 26.13-34 .55 , P < 0.0005 ) and improvements in quality of life ( mean difference of CS vs. placebo = 12.81-16 .76 , P < 0.001 ) , and body constitution in ` Qi-deficiency ' , ` Yang-deficiency ' , and ` Inherited Special ' ( mean difference of CS vs. placebo = 7.05-8 .12 , 7.56-8 .92 , and 4.48-8 .10 , P = 0.01 - < 0.0005 , 0.001-0 .004 , and 0.01 - < 0.0005 , accordingly , at three post-tests ) .
RESULTS	The participants who received YS also indicated significant greater improvements in symptom severity , quality of life , and a few patterns of body constitution when compared to the placebo group .
RESULTS	However , its effects were lesser in strength ( i.e. , smaller effect sizes ) , varieties of symptoms , and body constitution and sustainability over the 3 months .
CONCLUSIONS	The herbal formula CS was found effective to reduce symptoms and enhance quality of life in young adults ( nursing students ) with allergic rhinitis in ` Yang - and/or Qi-deficiency ' body constitution .
CONCLUSIONS	Further controlled trials of its effects in Chinese and/or Asians with allergic rhinitis in terms of socio-demographic , ethnic and illness characteristics and a longer-term follow-up are recommended .
BACKGROUND	The trial has registered at ClinicalTrials.gov with an ID : NCT02027194 ( 3 January 2014 ) .

###25591836
OBJECTIVE	To determine the impact of educational materials ( EMs ) on the treatment compliance of postmenopausal women with hormone receptor-positive ( HR + ) early-stage breast cancer .
METHODS	Patients ( n = 2757 ) were randomized to standard aromatase inhibitors ( AI ) alone ( group A ) or with EMs ( group B ) in a global , real-world setting .
RESULTS	The 2-year results ( n = 2242 ) showed EMs had no impact on compliance ( 82 vs. 82 % , group A vs. B ) , compliance with initial AI ( 82 vs. 81 % ) or persistence ( 90 vs. 88 % ) , confirming the 1-year interim analysis ( n = 2567 ) .
RESULTS	Of the 2082 patients considered compliant at 1 year , 77 % remained compliant at 2 years .
RESULTS	Discontinuations ( 9 % ) were mainly attributed to AI-related side effects ( 68 % of discontinuations ) .
RESULTS	Exploratory analyses suggest a relationship between patient characteristics and compliance behaviors .
CONCLUSIONS	EMs do not improve compliance in this patient population .
CONCLUSIONS	Compliance and persistence are complex end points influenced by multiple variables .
CONCLUSIONS	Side effects were the main reasons for discontinuations .

###24581525
OBJECTIVE	To determine whether the method of specimen preparation after transrectal ultrasound-guided biopsy of the prostate affected core fragmentation , and secondly to determine whether such fragmentation was influenced by the presence of malignancy in the biopsy specimen .
METHODS	A prospective randomized study comparing 2 different mechanisms of specimen preparation , wash vs swipe of biopsy cores , with blinded assessment by a specific uropathologist was undertaken .
RESULTS	For those cores in which prostate cancer was present , the wash method of specimen preparation resulted in fewer and longer core fragments ( P = .005 ) .
RESULTS	Those patients in whom cancer was present on biopsy also had a greater degree of biopsy core fragmentation in those cores in which only benign tissue was identified ( P = .017 ) .
RESULTS	Gleason score did not appear to influence the extent of fragmentation .
CONCLUSIONS	The method of specimen preparation at prostate biopsy influences the degree of fragmentation seen at histologic evaluation .
CONCLUSIONS	This has the potential to affect the interpretation of biopsy results , including suitability of patients for inclusion in active surveillance protocols .
CONCLUSIONS	Core fragmentation might be minimized by modification of technique .

###26026141
BACKGROUND	With aging , the detrimental effects of stress can impair a person 's ability to learn and sustain memory .
BACKGROUND	Humor and its associated mirthful laughter can reduce stress by decreasing the hormone cortisol .
BACKGROUND	Chronic release of cortisol can damage hippocampal neurons , leading to impairment of learning and memory .
BACKGROUND	Objectives The study intended to examine the effect of watching a humor video on short-term memory in older adults .
BACKGROUND	Design The research team designed a randomized , controlled trial .
METHODS	The study took place at Loma Linda University in Loma Linda , CA , USA .
METHODS	The study included 30 participants : 20 normal , healthy , older adults-11 males and 9 females-and 10 older adults with type 2 diabetes mellitus ( T2DM ) -6 males and 4 females .
METHODS	The study included 2 intervention groups of older adults who viewed humorous videos , a healthy group ( humor group ) , aged 69.9 3.7 y , and the diabetic group , aged 67.1 3.8 y. Each participant selected 1 of 2 humorous videos that were 20 min in length , either a Red Skeleton comedy or a montage of America 's Funniest Home Videos .
METHODS	The control group , aged 68.7 5.5 y , did not watch a humor video and sat in quiescence .
METHODS	A standardized , neuropsychological , memory-assessment tool , the Rey Auditory Verbal Learning Test ( RAVLT ) , was used to assess the following abilities : ( 1 ) learning , ( 2 ) recall , and ( 3 ) visual recognition .
METHODS	The testing occurred twice , once before ( RAVLT1 ) and once after ( RAVLT2 ) the humorous video for the humor and diabetic groups , and once before ( RAVLT1 ) and once after ( RAVLT2 ) the period of quiescence for the control group .
METHODS	At 5 time points , measurements of salivary cortisol were also obtained .
METHODS	The Kruskal-Wallis test was used to measure significance of the data based on the 3 groups .
RESULTS	In the humor , diabetic , and control groups , ( 1 ) learning ability improved by 38.5 % , 33.4 % , and 24.0 % , respectively ( P = .025 ) ; ( 2 ) delayed recall improved by 43.6 % , 48.1 % , and 20.3 % , respectively ( P = .064 ) ; and ( 3 ) visual recognition increased by 12.6 % , 16.7 % , and 8.3 % , respectively ( P = .321 ) .
RESULTS	For levels of salivary cortisol , the research team found significant and borderline decreases for the humor group between baseline and ( 1 ) post-RAVLT1 ( P = .047 ) , ( 2 ) postvideo ( P = .046 ) , and ( 3 ) post-RAVLT2 ( P = .062 ) .
RESULTS	The diabetic group showed significant decreases between baseline and ( 1 ) post-RAVLT1 ( P = .047 ) , ( 2 ) postvideo ( P = .025 ) , and ( 3 ) post-RAVLT2 ( P = .034 ) .
RESULTS	The study found no significant changes for the control group .
CONCLUSIONS	The research findings supported potential clinical and rehabilitative benefits for humor that can be applied to whole-person wellness programs for older adults .
CONCLUSIONS	The cognitive components-learning ability and delayed recall-become more challenging as individuals age and are essential to older adults for providing a high quality of life : mind , body , and spirit .
CONCLUSIONS	Because older adults can experience age-related memory deficits , complementary , enjoyable , and beneficial humor therapies should be implemented for them .

###24256611
BACKGROUND	Statins have beneficial effects on cardiovascular morbidity and mortality independently of reduction of plasma cholesterol .
OBJECTIVE	In patients with type 2 diabetes and nephropathy , chronic kidney disease stage II-III , we tested the hypothesis that atorvastatin increased systemic and renal nitric oxide ( NO ) availability using L-NMMA as an inhibitor of NO production .
OBJECTIVE	We performed a randomized , placebo-controlled , crossover study , using atorvastatin/placebo treatment for five days with a standardized diet and fluid intake .
OBJECTIVE	We measured brachial BP ( bBP ) , central BP ( cBP ) , GFR , urinary output ( OU ) , free water clearance ( CH2O ) , fractional excretion of sodium ( FENa ) , urinary excretion of albumin ( UAER and UACR ) , AQP2 ( u-AQP2 ) and ENaC ( u-ENaC ) and plasma concentrations of vasoactive hormones : renin , angiotensin II , aldosterone , arginine vasopressin , endothelin-1 and brain natriuretic peptide .
RESULTS	During atorvastatin and placebo treatment , L-NMMA infusion , changed the effect variables significantly , but to the same extent , i.e. an increase in bBP and cBP , and a decrease in GFR , OU , CH2O , FENa , u-AQP2 and u-ENaC .
RESULTS	In addition , renin and angiotensin II was reduced , aldosterone increased , and vasopressin , endothelin-1 and brain natriuretic hormone unchanged .
CONCLUSIONS	During , atorvastatin and placebo treatment , inhibition of nitric oxide synthesis induced the same response in brachial and central blood pressure , GFR , renal tubular function and vasoactive hormones .
CONCLUSIONS	Thus , atorvastatin did not change nitric oxide availability in type 2 diabetics with nephropathy .

###24656142
BACKGROUND	Despite scientific advances in typing of C. difficile strains very little is known about how hospital staff use typing results during periods of increased incidence ( PIIs ) .
BACKGROUND	This qualitative study , undertaken alongside a randomised controlled trial ( RCT ) , explored this issue .
BACKGROUND	The trial compared ribotyping versus more rapid genotyping ( MLVA or multilocus variable repeat analysis ) and found no significant difference in post 48 hour cases ( C difficile transmissions ) .
METHODS	In-depth qualitative interviews with senior staff in 11/16 hospital trusts in the trial ( 5 MLVA and 6 Ribotyping ) .
METHODS	Semi-structured interviews were conducted at end of the trial period .
METHODS	Transcripts were content analysed using framework analysis supported by NVivo-8 software .
METHODS	Common sub-themes were extracted by two researchers independently .
METHODS	These were compared and organised into over-arching categories or ` super-ordinate themes ' .
RESULTS	The trial recorded that 45 % of typing tests had some impact on infection control ( IC ) activities .
RESULTS	Interviews indicated that tests had little impact on initial IC decisions .
RESULTS	These were driven by hospital protocols and automatically triggered when a PII was identified .
RESULTS	To influence decision-making , a laboratory turnaround time < 3 days ( ideally 24 hours ) was suggested ; MLVA turnaround time was 5.3 days .
RESULTS	Typing results were predominantly used to modify initiated IC activities such as ward cleaning , audits of practice or staff training ; major decisions ( e.g. ward closure ) were unaffected .
RESULTS	Organisational factors could limit utilisation of MLVA results .
RESULTS	Results were twice as likely to be reported as ` aiding management ' ( indirect benefit ) than impacting on IC activities ( direct effect ) .
RESULTS	Some interviewees considered test results provided reassurance about earlier IC decisions ; others identified secondary benefits on organisational culture .
RESULTS	An underlying benefit of improved discrimination provided by MLVA typing was the ability to explore epidemiology associated with CDI cases in a hospital more thoroughly .
CONCLUSIONS	Ribotyping and MLVA are both valued by users .
CONCLUSIONS	MLVA had little additional direct impact on initial infection control decisions .
CONCLUSIONS	This would require reduced turnaround time .
CONCLUSIONS	The major impact is adjustments to earlier IC measures and retrospective reassurance .
CONCLUSIONS	For this , turnaround time is less important than discriminatory power .
CONCLUSIONS	The potential remains for wider use of genotyping to examine transmission routes .

###24453077
OBJECTIVE	To test whether red blood cell ( RBC ) levels of marine omega-3 fatty acids measured in the Women 's Health Initiative Memory Study were related to MRI brain volumes measured 8 years later .
METHODS	RBC eicosapentaenoic acid ( EPA ) , docosahexaenoic acid ( DHA ) , and MRI brain volumes were assessed in 1,111 postmenopausal women from the Women 's Health Initiative Memory Study .
METHODS	The endpoints were total brain volume and anatomical regions .
METHODS	Linear mixed models included multiple imputations of fatty acids and were adjusted for hormone therapy , time since randomization , demographics , intracranial volume , and cardiovascular disease risk factors .
RESULTS	In fully adjusted models , a 1 SD greater RBC EPA + DHA ( omega-3 index ) level was correlated with 2.1 cm ( 3 ) larger brain volume ( p = 0.048 ) .
RESULTS	DHA was marginally correlated ( p = 0.063 ) with total brain volume while EPA was less so ( p = 0.11 ) .
RESULTS	There were no correlations between ischemic lesion volumes and EPA , DHA , or EPA + DHA .
RESULTS	A 1 SD greater omega-3 index was correlated with greater hippocampal volume ( 50 mm ( 3 ) , p = 0.036 ) in fully adjusted models .
RESULTS	Comparing the fourth quartile vs the first quartile of the omega-3 index confirmed greater hippocampal volume ( 159 mm ( 3 ) , p = 0.034 ) .
CONCLUSIONS	A higher omega-3 index was correlated with larger total normal brain volume and hippocampal volume in postmenopausal women measured 8 years later .
CONCLUSIONS	While normal aging results in overall brain atrophy , lower omega-3 index may signal increased risk of hippocampal atrophy .
CONCLUSIONS	Future studies should examine whether maintaining higher RBC EPA + DHA levels slows the rate of hippocampal or overall brain atrophy .

###24734296
OBJECTIVE	To evaluate the analgesic and physiological effects of epidural morphine administered at the sixth and seventh lumbar or the fifth and sixth thoracic vertebrae in dogs undergoing thoracotomy .
METHODS	Prospective , randomized , blinded trial .
METHODS	Fourteen mixed-breed dogs , weighing 8.6 1.4 kg .
METHODS	The animals received acepromazine ( 0.1 mg kg ) IM and anesthesia was induced with propofol ( 4 mg kg ) IV .
METHODS	The lumbosacral space was punctured and an epidural catheter was inserted up to the region between the sixth and seventh lumbar vertebrae ( L , n = 6 ) or up to the fifth or sixth intercostal space ( T , n = 8 ) .
METHODS	The dogs were allowed to recover and after radiographic confirmation of correct catheter position , anesthesia was reinduced with propofol IV and maintained with 1.7 % isoflurane .
METHODS	Following stabilization of monitored parameters , animals received morphine ( 0.1 mg kg ) diluted in 0.9 % NaCl to a final volume of 0.25 mL kg via the epidural catheter , and after 40 minutes , thoracotomy was initiated .
METHODS	Heart rate and rhythm , systolic , mean and diastolic arterial pressures , respiratory rate , arterial hemoglobin oxygen saturation , partial pressure of expired CO and body temperature were measured immediately before the epidural administration of morphine ( 0 minute ) and every 10 minutes during the anesthetic period .
METHODS	The Melbourne pain scale and the visual analog scale were used to assess postoperative pain .
METHODS	The evaluation began 3 hours after the epidural administration of morphine and occurred each hour until rescue analgesia .
RESULTS	There were no important variations in the physiological parameters during the anesthetic period .
RESULTS	The post-operative analgesic period differed between the groups , being longer in T ( 9.9 01.6 hours ) compared with L ( 5.8 0.8 hours ) .
CONCLUSIONS	The use of morphine , at a volume of 0.25 mL kg 0.1 , administered epidurally over the thoracic vertebrae provided longer lasting analgesia than when deposited over the lumbar vertebrae .

###24536008
BACKGROUND	There are no randomized studies that compare outcomes after single-incision ( SLC ) and conventional multi-incision ( MLC ) laparoscopic cholecystectomy under an optimized perioperative analgesic regimen .
METHODS	This patient - and assessor-blinded randomized three-centre clinical trial compared SLC and MLC in women admitted electively with cholecystolithiasis .
METHODS	Outcomes were registered on the day of operation ( day 0 ) , on postoperative days 1 , 2 , 3 and 30 , and 12months after surgery .
METHODS	Blinding of the patients was maintained until day 3 .
METHODS	The primary endpoint was pain on movement measured on a visual analogue scale , reported repeatedly by the patient until day 3 .
RESULTS	The intention-to-treat population comprised 59 patients in the SLC and 58 in the MLC group .
RESULTS	There was no significant difference between the groups with regard to any of the pain-related outcomes , on-demand administration of opioids or general discomfort .
RESULTS	Median duration of surgery was 325min longer in the SLC group ( P < 0001 ) .
RESULTS	SLC was associated with a reduced incidence of vomiting on day 0 ( 7 versus 22 per cent ; P = 0019 ) .
RESULTS	The incidences of wound-related problems were comparable .
RESULTS	One patient in the SLC group experienced a biliary leak requiring endoscopic retrograde cholangiopancreatography .
RESULTS	The rates of incisional hernia at 12-month follow-up were 2 per cent in both groups .
RESULTS	Cosmetic rating was significantly improved after SLC at 1 and 12months ( P < 0001 ) .
CONCLUSIONS	SLC did not significantly diminish early pain in a setting with optimized perioperative analgesic patient care .
CONCLUSIONS	SLC may reduce postoperative vomiting .
BACKGROUND	NCT01268748 ( http://www.clinicaltrials.gov ) .

###24393479
BACKGROUND	The efficacy of artemisinin-based combination therapy ( ACT ) has been established .
BACKGROUND	The objective of the present study was to compare the efficacy and safety in the Central African Republic ( CAR ) of three commercially available artemisinin-based combinations , artemether + lumefantrine ( AL ) , artesunate + sulphamethoxypyrazine-pyrimethamine ( AS-SMP ) and artesunate + amodiaquine ( AS-AQ ) , with those of sulphadoxine-pyrimethamine + amodiaquine ( SP-AQ ) , which was the first-line reference treatment in the country from 2004 , until it was replaced by ACT in 2006 in accordance with changes in international recommendations based on resistance identified in other regions .
METHODS	Children aged six to 59 months with uncomplicated Plasmodium falciparum malaria were recruited in Bangui , the capital of the CAR .
METHODS	The 251 patients selected were randomly assigned to receive AL ( n = 60 ) , AS-SMP ( n = 58 ) , AS-AQ ( n = 68 ) or SP-AQ ( n = 65 ) and were followed up for 28 days .
METHODS	Clinical outcome was classified according to the standard 2003 World Health Organization protocol .
RESULTS	At day 28 , the cure rates in a per-protocol analysis were 92 % ( 48/52 ) with AL , 93 % ( 50/54 ) with AS-SMP , 93 % ( 55/59 ) with AS-AQ and 100 % ( 57/57 ) with SP-AQ , with no statistically significant difference between the four treatments .
RESULTS	Defervescence was significantly faster with AS-AQ than with AL ( p < 0.035 ) .
RESULTS	Fatigue was reported significantly more frequently by patients receiving AQ than by those treated with AS-SMP or AL ( p = 0.006 ) .
RESULTS	All the other adverse events reported were mild , and no significant difference was noted by treatment .
CONCLUSIONS	The three artemisinin-bsed combinations show similar , satisfactory results , comparable to that with SP-AQ .
CONCLUSIONS	This evaluation is the first conducted in CAR since the official introduction of ACT .
CONCLUSIONS	It should guide the National Malaria Control Programme in choosing the appropriate ACT for treatment of uncomplicated P. falciparum malaria in the future .

###24305799
OBJECTIVE	The control of body lice in homeless persons remains a challenge .
OBJECTIVE	To determine whether the use of long-lasting insecticide-treated underwear provides effective long-term protection against body lice in homeless persons .
METHODS	A randomized , double-blind , placebo-controlled trial was conducted in February and December 2011 in 2 homeless shelters ( Madrague Ville and Forbin ) in Marseille , France .
METHODS	Of the 125 homeless persons screened for eligibility , 73 body lice-infested homeless persons , 18 years or older , were enrolled .
METHODS	Body lice-infested homeless persons were randomly assigned to receive 0.4 % permethrin-impregnated underwear or an identical-appearing placebo for 45 days , in a 1:1 ratio , with a permuted block size of 10 .
METHODS	Visits were scheduled at days 14 and 45 .
METHODS	Data regarding the presence or absence of live body lice were collected .
METHODS	The primary and secondary end points were the proportions of homeless persons free of body lice on days 14 and 45 , respectively .
METHODS	Mutations associated with permethrin resistance in the body lice were also identified .
RESULTS	Significantly more homeless persons receiving permethrin-impregnated underwear than homeless persons receiving the placebo were free of body lice on day 14 in the intent-to-treat population ( 28 % vs 9 % ; P = .04 ) , with a between-group difference of 18.4 percentage points ( 95 % CI , 1.4-35 .4 ) , and in the per-protocol population ( 34 % vs 11 % ; P = .03 ) , with a between-group difference of 23.7 percentage points ( 95 % CI , 3.6-43 .7 ) .
RESULTS	This difference was not sustained on day 45 .
RESULTS	At baseline , the prevalence of the permethrin-resistant haplotype was 51 % in the permethrin group and 44 % in the placebo group .
RESULTS	On day 45 , the permethrin-resistant haplotype was significantly more frequent in the permethrin group than in the placebo group ( 73 % vs 45 % , P < .001 ) .
CONCLUSIONS	Permethrin-impregnated underwear is more efficient than placebo at eliminating body louse infestations by day 14 ; however , this difference was not sustained on day 45 .
CONCLUSIONS	The use of permethrin may have increased the resistance to permethrin in body lice and thus must be avoided .
BACKGROUND	clinicaltrials.gov Identifier : NCT01287663 .

###24552282
BACKGROUND	Animal studies have shown that methylphenidate ( MPH ) and fluoxetine ( FLX ) have different effects on dopaminergic and serotonergic system in the developing brain compared to the developed brain .
BACKGROUND	The effects of Psychotropic drugs On the Developing brain ( ePOD ) study is a combination of different approaches to determine whether there are related findings in humans .
METHODS	Animal studies were carried out to investigate age-related effects of psychotropic drugs and to validate new neuroimaging techniques .
METHODS	In addition , we set up two double-blind placebo controlled clinical trials with MPH in 50 boys ( 10-12 years ) and 50 young men ( 23-40 years ) suffering from ADHD ( ePOD-MPH ) and with FLX in 40 girls ( 12-14 years ) and 40 young women ( 23-40 years ) suffering from depression and anxiety disorders ( ePOD-SSRI ) .
METHODS	Trial registration numbers are : Nederlands Trial Register NTR3103 and NTR2111 .
METHODS	A cross-sectional cohort study on age-related effects of these psychotropic medications in patients who have been treated previously with MPH or FLX ( ePOD-Pharmo ) is also ongoing .
METHODS	The effects of psychotropic drugs on the developing brain are studied using neuroimaging techniques together with neuropsychological and psychiatric assessments of cognition , behavior and emotion .
METHODS	All assessments take place before , during ( only in case of MPH ) and after chronic treatment .
CONCLUSIONS	The combined results of these approaches will provide new insight into the modulating effect of MPH and FLX on brain development .

###25168032
BACKGROUND	Cigarette demand , or the change in cigarette consumption as a function of price , is a measure of reinforcement that is associated with level of tobacco dependence and other clinically relevant measures , but the effects of experimentally controlled income on real-world cigarette consumption have not been examined .
METHODS	In this study , income available for cigarette purchases was manipulated to assess the effect on cigarette demand .
METHODS	Tobacco-dependent cigarette smokers ( n = 15 ) who smoked 10-40 cigarettes per day completed a series of cigarette purchasing tasks under a variety of income conditions meant to mimic different weekly cigarette budgets : $ 280 , approximately $ 127 , $ 70 , or approximately $ 32 per week .
METHODS	Prices of $ 0.12 , $ 0.25 , $ 0.50 , and $ 1.00 per cigarette were assessed in each income condition .
METHODS	Participants were instructed to purchase as many cigarettes as they would like for the next week and to only consume cigarettes purchased in the context of the study .
METHODS	One price in 1 income condition was randomly chosen to be `` real , '' and the cigarettes and the excess money in the budget for that condition were given to the participant .
RESULTS	Results indicate that demand elasticity was negatively correlated with income .
RESULTS	Demand intensity ( consumption at low prices ) was unrelated to income condition and remained high across incomes .
CONCLUSIONS	These results indicate that the amount of income that is available for cigarette purchases has a large effect on cigarette consumption , but only at high prices .

###24399727
BACKGROUND	Fibrates were found to reduce cytokine release and low-grade inflammation in patients with impaired glucose tolerance .
BACKGROUND	The aim of this study was to investigate whether these effects of fibrates may be potentiated by metformin treatment .
METHODS	The study included 43 patients with isolated impaired glucose tolerance and normal plasma lipids who had been treated for at least 6 months with micronized fenofibrate ( 200 mg daily ) .
METHODS	These subjects were randomly assigned to 12 weeks ' treatment with either high dose metformin ( 3 g daily in three divided doses ) or placebo .
METHODS	Plasma lipids , glucose homeostasis markers , monocyte cytokine release and plasma C-reactive protein levels were determined before randomization and at the end of the treatment .
RESULTS	Metformin treatment reduced plasma C-reactive protein levels and monocyte release of tumor necrosis factor - and interleukin-6 , as well as tended to reduce monocyte release of interleukin-1 and monocyte chemoattractant protein-1 , which was accompanied by an improvement in insulin sensitivity .
CONCLUSIONS	Our results show that high-dose metformin produces monocyte-suppressing and systemic anti-inflammatory effects in fibrate-treated patients with isolated impaired glucose tolerance .
CONCLUSIONS	This suggests that fibrate-metformin combination therapy may bring clinical benefits to impaired glucose tolerance patients at high cardiovascular risk .

###25338198
OBJECTIVE	New models of health care delivery for dermatological care have the potential to increase access and improve patient-centered outcomes .
OBJECTIVE	To compare effectiveness of a direct-access , online model for follow-up dermatologic care in pediatric and adult patients with atopic dermatitis with that of in-person office visits .
METHODS	This was a 1-year , randomized controlled equivalency clinical trial in medically underserved areas , outpatient clinics , and the general community .
METHODS	Participants included children and adults with atopic dermatitis with access to the Internet , computers , and digital cameras .
METHODS	After an initial in-person visit , patients were randomized 1:1 to direct-access online or usual in-person care for follow-up management of atopic dermatitis .
METHODS	In the direct-access online group , patients captured and transmitted clinical images and history asynchronously to dermatologists online ; dermatologists evaluated the clinical information , provided recommendations and education , and prescribed medications online asynchronously .
METHODS	In the in-person group , patients visited dermatologists in their offices for follow-up care .
METHODS	Atopic dermatitis disease severity as assessed by patient-oriented eczema measure ( POEM ) and investigator global assessment ( IGA ) .
RESULTS	A total of 156 children and adults were randomized .
RESULTS	Between baseline and 12 months , the mean ( SD ) within-group difference in POEM score in patients in the direct-access online group was -5.1 ( 5.48 ) ( 95 % CI , -6.32 to -3.88 ) ; in the in-person group , the within-group difference was -4.86 ( 4.87 ) ( 95 % CI , -6.27 to -3.46 ) .
RESULTS	The difference in the change in POEM scores between the 2 groups was 0.24 ( 6.59 ) ( 90 % CI , -1.70 to 1.23 ) , which was contained within the predetermined 2.5 equivalence margin .
RESULTS	The percentage of patients achieving clearance or near-clearance of their disease ( IGA score of 0 or 1 ) was 38.4 % ( 95 % CI , 27.7 % to 49.3 % ) in the direct-access online group and 43.6 % ( 95 % CI , 32.6 % -54.6 % ) in the in-person group .
RESULTS	The difference in the percent of patients achieving clearance or near-clearance between the 2 groups was 5.1 % ( 90 % CI , 1.7 % -8.6 % ) , which was contained within the predetermined 10 % equivalence margin .
CONCLUSIONS	The direct-access online model results in equivalent improvements in atopic dermatitis clinical outcomes as in-person care .
CONCLUSIONS	Direct-access online care may represent an innovative model of delivering dermatological services to patients with chronic skin diseases .
BACKGROUND	clinicaltrials.gov Identifier : NCT00985894 .

###24975855
OBJECTIVE	We report the results of the investigation of safety and efficacy of venous angioplasty in patients with multiple sclerosis ( MS ) with findings of extracranial venous anomalies , considered hallmarks of chronic cerebrospinal venous insufficiency ( CCSVI ) , in a 2-phase study ( ClinicalTrials.gov NCT01450072 ) .
METHODS	Phase 1 was an open-label safety study ( 10 patients ) ; phase 2 was sham-controlled , randomized , and double-blind ( 10 sham procedure , 9 treated ) .
METHODS	All study patients fulfilled venous hemodynamic screening criteria indicative of CCSVI .
METHODS	Assessment was at 1 , 3 , and 6 months postprocedure with MRI , clinical , and hemodynamic outcomes .
METHODS	Primary endpoints were safety at 24 hours and 1 month , venous outflow restoration > 75 % at 1 month , and effect of angioplasty on new lesion activity and relapse rate over 6 months .
METHODS	Secondary endpoints included changes in disability , brain volume , cognitive tests , and quality of life .
RESULTS	No perioperative complications were noted ; however , one patient with history of syncope was diagnosed with episodic bradycardia requiring placement of a pacemaker before discharge .
RESULTS	Doppler evidence-based venous hemodynamic insufficiency severity score ( VHISS ) was reduced > 75 % compared to baseline in phase 1 ( at 1 month ) but not phase 2 .
RESULTS	In phase 2 , higher MRI activity ( cumulative number of new contrast-enhancing lesions [ 19 vs 3 , p = 0.062 ] and new T2 lesions [ 17 vs 3 , p = 0.066 ] ) and relapse activity ( 4 vs 1 , p = 0.389 ) were identified as nonsignificant trends in the treated vs sham arm over 6 months .
RESULTS	Using analysis of covariance , significant cumulative new T2 lesions were related to larger VHISS decrease ( p = 0.028 ) and angioplasty ( p = 0.01 ) over the follow-up .
RESULTS	No differences in other endpoints were detected .
CONCLUSIONS	Venous angioplasty is not an effective treatment for MS over the short term and may exacerbate underlying disease activity .
METHODS	This is a Class I study demonstrating that clinical and imaging outcomes are no better or worse in patients with MS identified with venous outflow restriction who receive venous angioplasty compared to sham controls who do not receive angioplasty .
METHODS	This study also includes a Class IV phase 1 study of safety in 10 patients receiving the angioplasty procedure .

###24642339
BACKGROUND	Previous efforts such as Assessing Care of Vulnerable Elders ( ACOVE ) provide quality indicators for assessing the care of elderly patients , but thus far little has been done to leverage this knowledge to improve care for these patients .
BACKGROUND	We describe a clinical decision support system to improve general practitioner ( GP ) adherence to ACOVE quality indicators and a protocol for investigating impact on GPs ' adherence to the rules .
METHODS	We propose two randomized controlled trials among a group of Dutch GP teams on adherence to ACOVE quality indicators .
METHODS	In both trials a clinical decision support system provides un-intrusive feedback appearing as a color-coded , dynamically updated , list of items needing attention .
METHODS	The first trial pertains to real-time automatically verifiable rules .
METHODS	The second trial concerns non-automatically verifiable rules ( adherence can not be established by the clinical decision support system itself , but the GPs report whether they will adhere to the rules ) .
METHODS	In both trials we will randomize teams of GPs caring for the same patients into two groups , A and B. For the automatically verifiable rules , group A GPs receive support only for a specific inter-related subset of rules , and group B GPs receive support only for the remainder of the rules .
METHODS	For non-automatically verifiable rules , group A GPs receive feedback framed as actions with positive consequences , and group B GPs receive feedback framed as inaction with negative consequences .
METHODS	GPs indicate whether they adhere to non-automatically verifiable rules .
METHODS	In both trials , the main outcome measure is mean adherence , automatically derived or self-reported , to the rules .
CONCLUSIONS	We relied on active end-user involvement in selecting the rules to support , and on a model for providing feedback displayed as color-coded real-time messages concerning the patient visiting the GP at that time , without interrupting the GP 's workflow with pop-ups .
CONCLUSIONS	While these aspects are believed to increase clinical decision support system acceptance and its impact on adherence to the selected clinical rules , systems with these properties have not yet been evaluated .
BACKGROUND	Controlled Trials NTR3566 .

###24302687
OBJECTIVE	To evaluate whether preterm very low birth weight ( VLBW ) infants receiving early iron ( EI ) supplementation ( 2 mg/kg/day elemental iron ) at 2 weeks postnatal age have improved serum ferritin levels compared with late iron ( LI ) supplementation at 6 weeks postnatal age .
METHODS	Single-blinded parallel-group interventional randomised controlled trial .
METHODS	Tertiary care centre in southern India .
METHODS	Randomised at 2 weeks postnatal age to EI and LI groups and evaluated at 2 , 6 and 12 weeks postnatal age .
RESULTS	The primary outcome was serum ferritin level at 12 weeks , and the secondary outcomes were the incidence of neonatal morbidities , haemoglobin level , anthropometric parameters and blood transfusion requirements .
RESULTS	Of the 104 babies randomised , outcomes were analysed in 46 and 47 babies in EI and LI groups , respectively .
RESULTS	Serum ferritin level was significantly higher ( p < 0.001 ) at 12 weeks ( 825 vs 633 ng/mL ) in the EI group .
RESULTS	Haemoglobin ( 10.10.4 vs 9.20.4 g/dL ) and mean corpuscular haemoglobin concentration ( 310.5 vs 29.40.5 g/dL ) were also significantly ( p < 0.001 ) higher at 12 weeks in the EI group .
RESULTS	There was a significant decrease of ferritin in the LI group and significant increase in ferritin in the EI group at 6 weeks compared with 2 weeks .
RESULTS	There were no significant differences in the incidences of neonatal morbidities ( necrotising enterocolitis , periventricular leukomalacia , retinopathy of prematurity ) , anthropometric parameters and blood transfusion requirements between the two groups .
CONCLUSIONS	EI supplementation in preterm VLBW infants improves serum ferritin and haemoglobin levels .
BACKGROUND	CTRI/2013/01 / 003277 .

###24449415
OBJECTIVE	To investigate whether providing sonographic ( US ) / MRI fusion images will enhance the ability of medical students and radiology residents to identify MSK anatomy on sonograms alone .
METHODS	Medical students ( n = 31 ) and radiology residents ( n = 23 ) were each randomly divided into two groups : Group A and Group B. Subjects in Group A were shown 10 MSK sonograms with arrows pointing to a specific anatomic structure or anatomic region .
METHODS	Subjects in Group B were shown the exact same 10 annotated sonograms as Group A as well as an additional fusion image consisting of an MRI of the same anatomy in the same plane fused with the sonogram without arrows .
METHODS	Sonograms and MRI were obtained from adult patients who consented to have their images used .
METHODS	The anatomic regions included the shoulder , hip , and pelvis .
METHODS	Both groups were given the same 10-question multiple choice examination to identify the anatomic structure that the arrow was marking on the sonogram .
METHODS	The transducer 's location was given for every question .
METHODS	One minute was allowed to answer each question .
METHODS	The Wilcoxon rank sum test was used to assess if there was a difference between Group A and Group B in both the medical student and the radiology resident cohorts .
RESULTS	Medical students : subjects in Group A ( n = 16 ) gave the correct answers in 33.8 % of the cases ( 54/160 ) .
RESULTS	Subjects in Group B ( n = 15 ) gave correct answers in 26.0 % of the cases ( 39/150 ) ( p value < 0.110 ) .
RESULTS	Radiology residents : subjects in Group A ( n = 11 ) gave correct answers in 40.9 % of the cases ( 45/110 ) .
RESULTS	Subjects in Group B ( n = 12 ) gave correct answers in 72.5 % of the cases ( 87/120 ) ( p value < 0.001 ) .
CONCLUSIONS	The addition of a fusion MRI/US image enhances radiology residents ' ability to identify MSK US anatomy accurately compared with the sonogram alone .
CONCLUSIONS	The medical students , however , did not show improvement with the addition of the fusion MRI/sonogram .
CONCLUSIONS	2014 .

###25496165
BACKGROUND	Penetrating keratoplasty can commonly restore vision in corneal blindness .
BACKGROUND	However , immunological graft reactions may induce irreversible graft failure in a substantial percentage .
BACKGROUND	Repeat keratoplasties in turn are associated with increased risk of graft failure and possibly irreversible blindness .
BACKGROUND	Topical as well as systemic immunosuppressants are administered for prophylaxis .
BACKGROUND	However , severe adverse effects limit long-term usage .
BACKGROUND	By contrast , matching for transplantation antigens might be effective for a long time .
METHODS	FANCY is a prospective , controlled , randomised , double-blind , multi-centre clinical trial with two parallel arms .
METHODS	The primary objective is to evaluate superiority of the proposed HLA matching strategy in comparison to random graft assignment with respect to the primary endpoint ` time to first endothelial graft rejection ' .
METHODS	Relevant inclusion criteria are age over 18years and waiting for penetrating or endothelial lamellar keratoplasty .
METHODS	The most important exclusion criteria are abuse of medication and/or drugs and an anticipated waiting time for an HLA match longer than 6months .
METHODS	After randomisation , patients either receive a HLA-matched graft ( experimental intervention ) or a random graft ( control intervention ) .
METHODS	The calculated sample size is 620 patients .
METHODS	The trial started in 2009 with a recruitment period of 24months .
METHODS	A total of 654 patients were included during this time .
CONCLUSIONS	The primary goal of FANCY is to assess whether histocompatibility matching is feasible and effective in the broad clinical routine .
CONCLUSIONS	However , during the course of the trial , the landscape of keratoplasty changed due to the rise of Descemet Membrane Endothelial Keratoplasty ( DMEK ) .
CONCLUSIONS	Nowadays , immune reactions are confined mostly to the ` high-risk ' subgroups .
CONCLUSIONS	If we would design FANCY in 2014 , we would narrow down the inclusion criteria to include only the high risk patients and accept longer waiting times for a matching donor here .
BACKGROUND	The unique identifying number of the FANCY trial is NCT00810472 .

###24625149
OBJECTIVE	We tested the impact of banning tobacco displays and posting graphic health warning signs at the point of sale ( POS ) .
METHODS	We designed 3 variations of the tobacco product display ( open , enclosed [ not visible ] , enclosed with pro-tobacco ads ) and 2 variations of the warning sign ( present vs absent ) with virtual store software .
METHODS	In December 2011 and January 2012 , we randomized a national convenience sample of 1216 adult smokers and recent quitters to 1 of 6 store conditions and gave them a shopping task .
METHODS	We tested for the main effects of the enclosed display , the sign , and their interaction on urge to smoke and tobacco purchase attempts .
RESULTS	The enclosed display significantly lowered current smokers ' ( B = -7.05 ; 95 % confidence interval [ CI ] = -13.20 , -0.91 ; P < .05 ) and recent quitters ' ( = -6.00 , 95 % CI = -11.00 , -1.00 ; P < .01 ) urge to smoke and current smokers ' purchase attempts ( adjusted odds ratio = 0.06 ; 95 % CI = 0.03 , 0.11 ; P < .01 ) .
RESULTS	The warning sign had no significant main effect on study outcomes or interaction with enclosed display .
CONCLUSIONS	These data show that POS tobacco displays influence purchase behavior .
CONCLUSIONS	Banning them may reduce cues to smoke and unplanned tobacco purchases .

###24929883
BACKGROUND	Topical corticosteroids are the most common first-line treatment for psoriasis .
BACKGROUND	Tachyphylaxis , a decreased response to treatment with repetitive application of the drug , is a controversial phenomenon associated with topical corticosteroid treatment .
OBJECTIVE	We sought to prove or disprove tachyphylaxis to occluded halobetasol 0.05 % versus vehicle .
METHODS	Patients with plaque psoriasis were recruited to this study .
METHODS	The study involved 3 phases ( 1 , 2A , and 2B ) with each phase being separated by a treatment vacation period .
METHODS	In phases 1 and 2A , 2 plaques were randomized to either halobetasol 0.05 % or vehicle ointment application .
METHODS	In phase 2B , halobetasol 0.05 % was applied to both .
METHODS	Target Lesion Severity Scale was used for clinical assessment .
RESULTS	Twenty patients were enrolled .
RESULTS	No difference in time to clearance ( P = .88 ) or time to recurrence ( P = .92 ) of the treated plaques was found between phases 1 and 2A .
RESULTS	Percentage of improvement was higher in phase 2A compared with phase 1 ( 89.4 % , P < .05 vs 71 % , P < .05 ) , as a result of reduction of vehicle effect .
RESULTS	In phase 2B , a greater improvement was found for previously corticosteroid-treated plaques .
CONCLUSIONS	Limitations are small sample size and 1 corticosteroid tested .
CONCLUSIONS	No evidence of tachyphylaxis to the topical corticosteroid halobetasol 0.05 % ointment treatment in patients with plaque psoriasis was found .

###25085304
BACKGROUND	A new , highly filled primer is currently marketed as a fluoride delivery system effective in reducing white spot lesions in orthodontic patients .
BACKGROUND	However , no studies in the literature support this claim .
BACKGROUND	The purpose of this in-vivo study was to investigate the retention and the efficacy of this primer in reducing the formation of white spot lesions .
METHODS	In each patient for whom premolar extractions were planned ( n = 22 ) , 1 premolar was randomly chosen as the experimental tooth for the application of the fluoride delivery system ( Opal Seal ; Ultradent Products , South Jordan , Utah ) , and the contralateral tooth was assigned as the control to receive the standard treatment ( Transbond XT ; 3M Unitek , Monrovia , Calif ) .
METHODS	After the bonding procedures , separators were placed around the premolar brackets to encourage plaque retention over 8 weeks .
METHODS	After the extractions , the tooth surfaces were evaluated visually and with microhardness techniques for demineralization .
METHODS	Primer retention was also investigated .
RESULTS	There were no statistically significant differences in the numbers of white spot lesions between the 2 groups .
RESULTS	The primer retention was calculated as 50 % .
CONCLUSIONS	The results indicated no significant difference between the efficacies of the fluoride-releasing primer and the control primer in reducing demineralization over the duration of the study .

###24268218
OBJECTIVE	We compared the outcomes of patients treated with everolimus-eluting stents ( EES ) versus paclitaxel-eluting stents ( PES ) at 3 years from the large-scale randomized SPIRIT IV trial .
BACKGROUND	SPIRIT IV is the largest randomized trial comparing the outcomes of EES and PES .
BACKGROUND	The present report represents the final long-term follow-up analysis from this study .
METHODS	A total of 3,687 patients were randomized 2:1 to EES or PES , stratified by presence of diabetes mellitus and lesion characteristics .
METHODS	Prespecified subgroups were compared for interaction with stent allocation .
METHODS	The primary end point was target lesion failure ( TLF ) ( the composite of cardiac death , target vessel-related myocardial infarction [ MI ] , or ischemia-driven target lesion revascularization ) .
RESULTS	At 3 years , TLF occurred in 9.2 % versus 11.7 % of EES - and PES-treated patients ( hazard ratio [ HR ] 0.78 [ 0.63-0 .97 ] , P = .02 ) .
RESULTS	The incidence of death or MI was 5.9 % versus 9.1 % , respectively ( HR 0.67 [ 0.52-0 .85 ] , P = .001 ) , and there was a 64 % reduction in stent thrombosis ( Academic Research Consortium definite or probable definition ) with EES ( 0.59 % vs 1.60 % , HR 0.36 [ 0.18-0 .72 ] , P = .003 ) .
RESULTS	The difference in target lesion revascularization at 3 years did not reach statistical significance ( 6.2 % vs 7.8 % , respectively , HR 0.78 [ 0.60-1 .01 ] , P = .06 ) .
RESULTS	There was no significant interaction between treatment allocation and any of the subgroups , including diabetes .
CONCLUSIONS	When compared with PES , EES provides durable and significant reduction in TLF , especially due to its enhanced safety profile , with lower rates of death or MI and stent thrombosis up to 3 years .

###24878273
OBJECTIVE	The development of minimally invasive surgical techniques is driven by the quest for better patient outcomes .
OBJECTIVE	There is some evidence for the use of minimally invasive surgery for degenerative lumbar spine stenosis ( LSS ) , but there are currently no studies comparing outcomes with matched controls .
OBJECTIVE	The object of this study was to compare outcomes following minimally invasive unilateral laminectomy for bilateral decompression ( ULBD ) to a standard `` open '' laminectomy for LSS .
METHODS	The authors conducted a prospective , 1:1 randomized trial comparing ULBD to open laminectomy for degenerative LSS .
METHODS	The study enrolled 79 patients between 2007 and 2009 , and adequate data for analysis were available in 54 patients ( 27 in each arm of the study ) .
METHODS	Patient demographic characteristics and clinical characteristics were recorded and clinical outcomes were obtained using pre - and postoperative Oswestry Disability Index ( ODI ) scores , visual analog scale ( VAS ) scores for leg pain , patient satisfaction index scores , and postoperative 12-Item Short Form Health Survey ( SF-12 ) scores .
RESULTS	Significant improvements were observed in ODI and VAS scores for both open and ULBD interventions ( p < 0.001 for both groups using either score ) .
RESULTS	In addition , the ULBD-treated patients had a significantly better mean improvement in the VAS scores ( p = 0.013 ) but not the ODI scores ( p = 0.055 ) compared with patients in the open-surgery group .
RESULTS	ULBD-treated patients had a significantly shorter length of postoperative hospital stay ( 55.1 vs. 100.8 hours , p = 0.0041 ) and time to mobilization ( 15.6 vs. 33.3 hours , p < 0.001 ) and were more likely to not use opioids for postoperative pain ( 51.9 % vs. 15.4 % , p = 0.046 ) .
CONCLUSIONS	Based on short-term follow-up , microscopic ULBD is as effective as open decompression in improving function ( ODI score ) , with the additional benefits of a significantly greater decrease in pain ( VAS score ) , postoperative recovery time , time to mobilization , and opioid use .

###24682080
OBJECTIVE	The benefit of adding sciatic nerve block ( SNB ) to femoral nerve block to improve analgesia after total knee arthroplasty ( TKA ) is uncertain .
OBJECTIVE	We hypothesized that the effective duration of single-injection SNB is too short to improve postoperative analgesia and that this contributes to conflicting results on the efficacy of SNB after TKA .
OBJECTIVE	We evaluated this hypothesis in a prospective double-blind randomized controlled trial .
METHODS	Sixty patients undergoing TKA were randomly allocated to a continuous SNB group or a single-injection SNB group .
METHODS	All patients received femoral nerve block ( 0.5 % ropivacaine 20 mL ) and SNB ( 0.2 % ropivacaine 20 mL ) and catheters were inserted into both peripheral nerve block sites before surgery .
METHODS	Both groups received continuous femoral nerve block and patient-controlled intravenous analgesia with morphine .
METHODS	Continuous SNB ( 0.2 % ropivacaine 5 mL/h ; continuous SNB group ) or sham continuous SNB ( 0.9 % normal saline 5 mL/h ; single-injection SNB group ) was provided after surgery .
METHODS	The primary outcome was total morphine consumption for 48 hours after surgery .
RESULTS	Total morphine consumption in the 48-hour period after surgery was significantly lower in the continuous SNB group compared with the single-injection SNB group [ 4.9 ( 5.9 ) vs 9.7 ( 9.5 ) mg , P = 0.002 ] .
RESULTS	Visual analog scale pain scores at rest were also significantly lower in the continuous SNB group ( P = 0.035 ) .
CONCLUSIONS	The combination of continuous femoral and SNB provides a superior opioid sparing effect and improves analgesia after TKA .

###24667750
OBJECTIVE	Direct evidence for the effects of vegetable intake on weight loss is qualified .
OBJECTIVE	The study aimed to assess the effect of higher vegetable consumption on weight loss .
METHODS	A single blind parallel controlled trial was conducted with 120 overweight adults ( mean body mass index = 29.98 kg/m ( 2 ) ) randomised to two energy deficit healthy diet advice groups differing only by doubling the serving ( portion ) sizes of vegetables in the comparator group .
METHODS	Data were analysed as intention-to-treat using a linear mixed model .
METHODS	Spearmans rho bivariate was used to explore relationships between percentage energy from vegetables and weight loss .
RESULTS	After 12 months , the study sample lost 6.55.2 kg ( P < 0.001 time ) with no difference between groups ( P > 0.05 interaction ) .
RESULTS	Both groups increased vegetable intake and lost weight in the first 3 months , and the change in weight was significantly correlated with higher proportions of energy consumed as vegetables ( rho = -0.217 , P = 0.024 ) .
RESULTS	Fasting glucose , insulin and triglyceride levels decreased ( P < 0.001 time ) and high-density lipoprotein cholesterol levels increased ( P < 0.001 time ) , with no difference between groups .
RESULTS	Weight loss was sustained for 12 months by both groups , but the comparator group reported greater hunger satisfaction ( P = 0.005 ) .
CONCLUSIONS	Advice to consume a healthy low-energy diet leads to sustained weight loss , with reductions in cardiovascular disease risk factors regardless of an emphasis on more vegetables .
CONCLUSIONS	In the short term , consuming a higher proportion of the dietary energy as vegetables may support a greater weight loss and the dietary pattern appears sustainable .

###24280463
OBJECTIVE	To study the effectiveness of yoga intervention on oxidative stress , glycemic status , blood pressure and anthropometry in prediabetes .
METHODS	Randomized-controlled trial .
METHODS	Twenty nine prediabetes subjects aged 30-75 years .
METHODS	Yoga was conducted at 4 different community diabetes clinics in Mangalore , India .
METHODS	Participants were randomized to either 3-month yoga or wait-list control groups .
METHODS	Malondialdehyde , glutathione , vitamin C , vitamin E , superoxide dismutase , plasma glucose , glycated haemoglobin , BMI , waist circumference , waist-to-hip ratio and blood pressure .
RESULTS	Yoga intervention resulted in a significant decline in malondialdehyde ( p < 0.001 ) , relative to the control group .
RESULTS	In comparison with the control , there was a significant improvement in BMI , waist circumference , systolic blood pressure and fasting glucose levels at follow-up .
RESULTS	No significant improvement in glycated haemoglobin , waist-to-hip ratio or any of the antioxidants was observed .
CONCLUSIONS	Yoga intervention may be helpful in control of oxidative stress in prediabetes subjects .
CONCLUSIONS	Yoga can also be beneficial in reduction in BMI , waist circumference , systolic blood pressure and fasting glucose .
CONCLUSIONS	Effect of yoga on antioxidant parameters was not evident in this study .
CONCLUSIONS	The findings of this study need to be confirmed in larger trials involving active control groups .

###24668760
BACKGROUND	Preliminary evidence suggests intravenous ketamine has rapid effects on suicidal cognition , making it an attractive candidate for depressed patients at imminent risk of suicide .
BACKGROUND	In the first randomized controlled trial of ketamine using an anesthetic control condition , we tested ketamine 's acute effects on explicit suicidal cognition and a performance-based index of implicit suicidal cognition ( Implicit Association Test ; IAT ) previously linked to suicidal behavior .
METHODS	Symptomatic patients with treatment-resistant unipolar major depression ( inadequate response to 3 antidepressants ) were assessed using a composite index of explicit suicidal ideation ( Beck Scale for Suicidal Ideation , Montgomery-Asberg Rating Scale suicide item , Quick Inventory of Depressive Symptoms suicide item ) and the IAT to assess suicidality implicitly .
METHODS	Measures were taken at baseline and 24 hr following a single subanesthetic dose of ketamine ( n = 36 ) or midazolam ( n = 21 ) , a psychoactive placebo agent selected for its similar , rapid anesthetic effects .
METHODS	Twenty four hours postinfusion , explicit suicidal cognition was significantly reduced in the ketamine but not the midazolam group .
RESULTS	Fifty three percent of ketamine-treated patients scored zero on all three explicit suicide measures at 24 hr , compared with 24 % of the midazolam group ( ( 2 ) = 4.6 ; P = .03 ) .
RESULTS	Implicit associations between self - and escape-related words were reduced following ketamine ( P = .01 ; d = .58 ) but not midazolam ( P = .68 ; d = .09 ) .
RESULTS	Ketamine-specific decreases in explicit suicidal cognition were largest in patients with elevated suicidal cognition at baseline , and were mediated by decreases in nonsuicide-related depressive symptoms .
CONCLUSIONS	Intravenous ketamine produces rapid reductions in suicidal cognition over and above active placebo .
CONCLUSIONS	Further study is warranted to test ketamine 's antisuicidal effects in higher-risk samples .

###25200570
OBJECTIVE	To evaluate the efficacy and safety of twice-daily dosing of dapagliflozin and metformin , exploring the feasibility of a fixed-dose combination .
METHODS	In this 16-week , phase III , randomized , double-blind placebo-controlled study , adults who were receiving metformin administered twice daily ( 1500mg/day ) and had inadequate glycaemic control were randomized 1:1:1:1 to receive dapagliflozin twice daily ( 2.5 or 5mg ) , placebo or dapagliflozin 10mg once daily ( which was included as a benchmark ) .
METHODS	The primary endpoint was change from baseline glycated haemoglobin ( HbA1c ) level .
METHODS	Secondary endpoints included changes in fasting plasma glucose ( FPG ) level and body weight .
RESULTS	Four hundred adults were randomized to dapagliflozin ( 2.5 mg twice daily , 5mg twice daily , 10mg once daily ) or placebo co-administered with metformin twice daily .
RESULTS	At 16 weeks , the adjusted mean change in HbA1c from baseline was significantly reduced in the dapagliflozin 2.5 mg twice daily and 5mg twice daily groups versus placebo ( -0.52 vs. -0.30 % , p = 0.0106 and -0.65 % vs. -0.30 % , p < 0.0001 ) .
RESULTS	There were also significantly greater improvements for dapagliflozin twice daily groups versus placebo in FPG body weight and achievement of HbA1c level of < 7 % .
RESULTS	Efficacy outcomes for dapagliflozin twice daily were numerically similar to those for dapagliflozin once daily .
RESULTS	Dapagliflozin twice daily was well tolerated .
CONCLUSIONS	Dapagliflozin 2.5 or 5mg twice daily added to metformin was effective in reducing glycaemic levels in patients with type 2 diabetes inadequately controlled with metformin alone .
CONCLUSIONS	This study supports the development of a fixed-dose combination regimen .

###24710972
BACKGROUND	The commonly used therapeutic approach , the contemporary Bobath approach ( CBA ) , is not sufficient to restore independent locomotion for individuals with severe motor deficit ( SMD ) after stroke .
BACKGROUND	Therefore , we propose that the early sitting , standing , and walking in conjunction with the CBA ( ECBA ) be used to treat individuals with SMD after stroke .
OBJECTIVE	To investigate whether ECBA may enhance mobility and balance in subjects with SMD after stroke .
METHODS	Thirty-three men and 15 women , aged 60 to 74 years , with SMD after stroke were recruited for the study .
METHODS	CBA or ECBA was performed with the subjects 5 times per week in 50-minute sessions for 8 weeks .
METHODS	The Stroke Rehabilitation Assessment of Movement ( STREAM ) and the Berg Balance Scale were implemented before treatment and at 4 and 8 weeks after treatment , respectively .
RESULTS	The STREAM scores indicated that ECBA was more efficient than the CBA intervention for lower extremity mobility , F ( 1 , 46 ) = 24.0 , P < .001 , and basic mobility , F ( 1 , 46 ) = 102.6 , P < .001 .
RESULTS	Overall STREAM scores were higher in the ECBA group , F ( 1 , 46 ) = 24.1 , P < .001 , after 8 weeks of therapy .
RESULTS	Balance scores of the ECBA subjects were higher than those of the CBA subjects after 8 weeks of therapy , F ( 1 , 46 ) = 73.1 , P < .001 .
RESULTS	However , there was no difference in upper extremity mobility between the 2 groups .
CONCLUSIONS	ECBA is a valuable intervention to improve lower extremity mobility , basic mobility , and balance ability for individuals with SMD after stroke .

###25006718
BACKGROUND	Clomiphene is the current first-line infertility treatment in women with the polycystic ovary syndrome , but aromatase inhibitors , including letrozole , might result in better pregnancy outcomes .
METHODS	In this double-blind , multicenter trial , we randomly assigned 750 women , in a 1:1 ratio , to receive letrozole or clomiphene for up to five treatment cycles , with visits to determine ovulation and pregnancy , followed by tracking of pregnancies .
METHODS	The polycystic ovary syndrome was defined according to modified Rotterdam criteria ( anovulation with either hyperandrogenism or polycystic ovaries ) .
METHODS	Participants were 18 to 40 years of age , had at least one patent fallopian tube and a normal uterine cavity , and had a male partner with a sperm concentration of at least 14 million per milliliter ; the women and their partners agreed to have regular intercourse with the intent of conception during the study .
METHODS	The primary outcome was live birth during the treatment period .
RESULTS	Women who received letrozole had more cumulative live births than those who received clomiphene ( 103 of 374 [ 27.5 % ] vs. 72 of 376 [ 19.1 % ] , P = 0.007 ; rate ratio for live birth , 1.44 ; 95 % confidence interval , 1.10 to 1.87 ) without significant differences in overall congenital anomalies , though there were four major congenital anomalies in the letrozole group versus one in the clomiphene group ( P = 0.65 ) .
RESULTS	The cumulative ovulation rate was higher with letrozole than with clomiphene ( 834 of 1352 treatment cycles [ 61.7 % ] vs. 688 of 1425 treatment cycles [ 48.3 % ] , P < 0.001 ) .
RESULTS	There were no significant between-group differences in pregnancy loss ( 49 of 154 pregnancies in the letrozole group [ 31.8 % ] and 30 of 103 pregnancies in the clomiphene group [ 29.1 % ] ) or twin pregnancy ( 3.4 % and 7.4 % , respectively ) .
RESULTS	Clomiphene was associated with a higher incidence of hot flushes , and letrozole was associated with higher incidences of fatigue and dizziness .
RESULTS	Rates of other adverse events were similar in the two treatment groups .
CONCLUSIONS	As compared with clomiphene , letrozole was associated with higher live-birth and ovulation rates among infertile women with the polycystic ovary syndrome .
CONCLUSIONS	( Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others ; ClinicalTrials.gov number , NCT00719186 . )

###25082564
OBJECTIVE	Retrospective subgroup analysis in JMDB study indicates that the between-arm differences in overall survival ( OS ) in the East Asian subgroup were consistent with those observed in the entire JMDB study population .
OBJECTIVE	This bridging study ( JMIL ) further evaluated the efficacy and safety of first-line pemetrexed/cisplatin ( PC ) versus gemcitabine/cisplatin ( GC ) in Chinese patients with nonsquamous non-small cell lung cancer ( NSCLC ) .
OBJECTIVE	The primary endpoint of this local registration trial was designed to compare OS in the combined dataset , consisting of Chinese patients in JMIL and 1252 nonsquamous patients in JMDB .
METHODS	Chinese patients with stage IIIB/IV nonsquamous NSCLC were randomly assigned ( 1:1 ) to 6 cycles maximum ( 21 days/cycle ) of pemetrexed 500mg/m ( 2 ) + cisplatin 75mg/m ( 2 ) ( day 1 ) , or gemcitabine 1250mg/m ( 2 ) ( days 1 and 8 ) + cisplatin 75mg/m ( 2 ) ( day 1 ) .
RESULTS	In JMIL , 256 Chinese patients were randomized ( PC , n = 126 ; GC , n = 130 ) .
RESULTS	Patient baseline characteristics were balanced between treatment arms .
RESULTS	In the combined dataset , PC was superior to GC in prolonging OS , with adjusted hazard ratio ( HR ) of 0.87 ( 95 % CI : 0.77-0 .98 , p = 0.023 ) and median OS of 11.76 versus 10.94 months .
RESULTS	In the JMIL-only population , no significant OS difference observed between treatment arms ( adjusted HR = 1.03 [ 95 % CI : 0.77-1 .39 , p = 0.822 ] ; unadjusted HR = 0.996 [ 95 % CI : 0.74-1 .33 , p = 0.980 ] ) , nor for other secondary efficacy endpoints .
RESULTS	Significantly fewer patients in the PC arm experienced drug-related grade 3/4 toxicities , 54 ( 43.2 % ) versus 71 ( 55.9 % ) for GC ( p = 0.045 ) , with significantly lower rates of leukocytopenia , thrombocytopenia , and fatigue .
CONCLUSIONS	This study showed that in the combined population , OS of PC was superior to GC , while in the Chinese-only population , no significant difference was observed ; a better safety and risk/benefit profile was found in the PC arm .
CONCLUSIONS	A PC regimen should be considered as a standard of care in Chinese nonsquamous NSCLC patients in a first-line setting .

###24982490
BACKGROUND	Physical inactivity is a major , potentially modifiable , risk factor for cardiovascular disease , cancer , and other chronic diseases .
BACKGROUND	Effective , simple , and generalisable interventions that will increase physical activity in populations are needed .
OBJECTIVE	To evaluate the effectiveness of a smartphone application ( app ) to increase physical activity in primary care .
METHODS	An 8-week , open-label , randomised controlled trial in rural , primary care in the west of Ireland .
METHODS	Android smartphone users > 16 years of age were recruited .
METHODS	All participants were provided with similar physical activity goals and information on the benefits of exercise .
METHODS	The intervention group was provided with a smartphone app and detailed instructions on how to use it to achieve these goals .
METHODS	The primary outcome was change in physical activity , as measured by a daily step count between baseline and follow-up .
RESULTS	A total of 139 patients were referred by their primary care health professional or self-referred .
RESULTS	In total , 37 ( 27 % ) were screened out and 12 ( 9 % ) declined to participate , leaving 90 ( 65 % ) patients who were randomised .
RESULTS	Of these , 78 provided baseline data ( intervention = 37 ; control = 41 ) and 77 provided outcome data ( intervention = 37 ; control = 40 ) .
RESULTS	The mean daily step count at baseline for intervention and control groups was 4365 and 5138 steps per day respectively .
RESULTS	After adjusting , there was evidence of a significant treatment effect ( P = 0.009 ) ; the difference in mean improvement in daily step count from week 1 to week 8 inclusive was 1029 ( 95 % confidence interval 214 to 1843 ) steps per day , favouring the intervention .
RESULTS	Improvements in physical activity in the intervention group were sustained until the end of the trial .
CONCLUSIONS	A simple smartphone app significantly increased physical activity over 8 weeks in a primary care population .

###24308191
OBJECTIVE	To observe the therapeutic effect of cervical paravertebral block plus acupuncture treatment for cervicogenic headache .
METHODS	Sixty cases of cervicogenic headache were randomly and equally divided into cervical paravertebral block ( control ) group and acupuncture plus cervical paravertebral block ( acupuncture ) group .
METHODS	Paravertebral block was performed by injection of 5 mL of 0.3 % lidocaine solution containing triamcinolone ( 10 mg ) into the 2nd cervical paravertebral tissue from the cross point between the posterior border of the sternomastoid muscle and the angle of jaw , once every week for three weeks .
METHODS	Manual acupuncture stimulation was applied to Baihui ( GV 20 ) , unilateral Fengchi ( GB 20 ) and Jiaosun ( SJ 20 ) , once daily for 3 weeks .
METHODS	The patients ' headache severity was assessed by visual analogue scale ( VAS ) and their cervical vertebral activity assessed by range of motion ( ROM ) before and after the treatment .
RESULTS	Compared with pre-treatment in the same one group , the scores of both VAS and ROM at time points of one , two and three weeks after the treatment were significantly decreased in the control and acupuncture groups ( P < 0.05 ) , suggesting a marked improvement of both headache and cervical motion after the treatment .
RESULTS	Comparison between the two groups showed that the VAS and ROM scores of the acupuncture group were evidently lower than those of the control group at each time point after the treatment ( P < 0.05 ) , displaying a better therapeutic effect of acupuncture plus paravertebral block for cervicogenic headache .
CONCLUSIONS	Acupuncture combined with cervical paravertebral block is effective in relieving cervicogenic headache and improving cervical vertebral activity in cervicogenic headache patients , and can strengthen the therapeutic effect of simple paravertebral block .

###24667502
OBJECTIVE	Anatomy education on embalmed specimens is presumed to have added educational value .
OBJECTIVE	However , although embalmed specimens have been used for anatomy education for years , there is little evidence on the added educational value of dissection-based teaching .
OBJECTIVE	The objective of this randomized study is to examine the added value of dissection-based teaching , using models of the inguinal region in embalmed specimens .
METHODS	In 2011 , medical students at Erasmus Medical Center , The Netherlands , were randomly assigned to three groups .
METHODS	Group I attended lectures , group II attended dissection-based training using laparoscopic dissection models , and group III attended lectures as well as dissection-based laparoscopic training .
METHODS	To assess the improvement of anatomical knowledge , all students had to complete a practical test before , immediately after , and two weeks after training .
METHODS	Data were analyzed with mixed modeling .
RESULTS	Forty-six students participated in this study .
RESULTS	No significant difference in results was observed among the three groups before the start of training .
RESULTS	Immediately after the course , groups II and III scored significantly higher than group I ( P < .001 ; P < .001 ) , and group II scored higher than group III ( P = .009 ) .
RESULTS	The difference between group I and groups II and III persisted during follow-up ( P = 012 ; P = .001 ) .
RESULTS	The difference between groups II and III disappeared .
CONCLUSIONS	Three-dimensional anatomy education with dissection models enhances anatomy learning by medical students .
CONCLUSIONS	Students who received dissection-based training scored higher in the short - and long term compared with students who did not receive this type of education .

###24300788
OBJECTIVE	Active immunotherapy is a promising antitumoral strategy ; however its use in combination with chemotherapy in dogs with large B-cell lymphoma ( DLBCL ) remains largely untested .
OBJECTIVE	Heat shock proteins ( HSP ) bind the small peptides they chaperone ( HSPPC ) , allowing for immunization of the host against a large repertoire of tumor-associated antigens .
OBJECTIVE	Hydroxylapatite vehicles HSPPCs and acts as an immunologic adjuvant .
OBJECTIVE	The aim of this study was to show that an autologous vaccine with hydroxylapatite and tumor-derived HSPPCs is safe and therapeutically effective in dogs with DLBCL .
METHODS	Nineteen dogs with naturally occurring DLBCL were entered into a prospective randomized placebo-controlled double-blinded trial of HSPPCs-hydroxylapatite plus chemotherapy versus chemotherapy alone .
METHODS	Endpoints included time to progression ( TTP ) , lymphoma-specific survival ( LSS ) , and incidence of toxicoses .
RESULTS	Median first TTP after randomization to the vaccine arm was 304 days versus 41 days for the control arm ( P = 0.0004 ) .
RESULTS	There was also a statistically significant difference in duration of second remission between the two groups ( P = 0.02 ) .
RESULTS	Median LSS was 505 days for the vaccinated dogs versus 159 days for the unvaccinated dogs ( P = 0.0018 ) .
RESULTS	Six vaccinated dogs achieved molecular remission , as shown by clonal immunoglobulin H ( IgH ) rearrangement .
RESULTS	Toxicoses were comparable between the two treatment arms .
CONCLUSIONS	The results of this trial demonstrate that the autologous vaccine tested here is safe and efficacious in prolonging TTP and LSS in dogs with DLBCL when used in combination with dose-intense chemotherapy .
CONCLUSIONS	On the basis of these results , additional evaluation of this novel therapeutic strategy is warranted in human DLBCL .

###25062592
OBJECTIVE	Longitudinal studies have begun to clarify the phenotypic characteristics of adolescents and young adults at clinical high risk for psychosis .
OBJECTIVE	This 8-site randomized trial examined whether a 6-month program of family psychoeducation was effective in reducing the severity of attenuated positive and negative psychotic symptoms and enhancing functioning among individuals at high risk .
METHODS	Adolescents and young adults ( mean age 17.4 4.1 years ) with attenuated positive psychotic symptoms , brief and intermittent psychosis , or genetic risk with functional deterioration were randomly assigned to 18 sessions of family-focused therapy for individuals at clinical high risk ( FFT-CHR ) in 6 months or 3 sessions of family psychoeducation ( enhanced care [ EC ] ) .
METHODS	FFT-CHR included psychoeducation about early signs of psychosis , stress management , communication training , and problem-solving skills training , whereas EC focused on symptom prevention .
METHODS	Independent evaluators assessed participants at baseline and 6 months on positive and negative symptoms andsocial-role functioning .
RESULTS	Of 129 participants , 102 ( 79.1 % ) were followed up at 6months .
RESULTS	Participants in FFT-CHR showed greater improvements in attenuated positive symptoms over 6 months than participants in EC ( F1 ,97 = 5.49 , p = .02 ) .
RESULTS	Negative symptoms improved independently of psychosocial treatments .
RESULTS	Changes in psychosocial functioning depended on age : participants more than 19 years of age showed more role improvement inFFT-CHR , whereas participants between 16 and 19 years of age showed more role improvement in EC .
RESULTS	The results were independent of concurrent pharmacotherapy .
CONCLUSIONS	Interventions that focus on improving family relationships may have prophylactic efficacy in individuals at high risk for psychosis .
CONCLUSIONS	Future studies should examine the specificity of effects of family intervention compared to individual therapy of the sameduration and frequency .
CONCLUSIONS	Clinical trial registration information-Prevention Trial of Family Focused Treatment in Youth at Risk for Psychosis ; http://clinicaltrials.gov/; NCT01907282 .

###25351456
OBJECTIVE	Cancer anorexia-cachexia syndrome ( CACS ) is common in advanced cancer patients and associated with weight loss , fatigue , impaired quality of life ( QoL ) , and poor prognosis .
OBJECTIVE	The goal of this project was to identify the most responsive items from two QoL measures in the ROMANA 2 ( NCT01387282 ) phase III global study evaluating anamorelin HCl in the treatment of non-small cell lung cancer ( NSCLC ) cachexia : the Functional Assessment of Chronic Illness Therapy-Fatigue ( FACIT-F ) and the Functional Assessment of Anorexia/Cachexia Therapy ( FAACT ) .
METHODS	In the ROMANA 2 trial , 477 patients with unresectable stage III or IV NSCLC and cachexia were to be enrolled and randomized ( 2:1 ) to receive anamorelin HCl or placebo once daily for 12weeks .
METHODS	All 203 patients who reached the week 12 visit at the time of data analysis were included .
METHODS	Co-primary endpoints were change from baseline in lean body mass and handgrip strength .
METHODS	QoL was a secondary outcome with FACIT-F and FAACT questionnaires administered at baseline and at weeks 3 , 6 , 9 , and 12 .
RESULTS	Two 4-item scales ( fatigue/activity and appetite/eating ) from the FACIT-F and FAACT questionnaires , respectively , demonstrated good internal consistency reliability , validity , and responsiveness ( also referred to as the Simplified Evaluation of Fatigue ( SEF ) and Simplified Evaluation of Appetite ( SEA ) , respectively ) .
RESULTS	The estimated important difference for each scale was 1-2 points .
CONCLUSIONS	These brief scales provide the psychometric properties necessary to promote future research in NSCLC patients with CACS .
CONCLUSIONS	Additional work should examine the clinical utility of these scales and their impact on treatment decision-making .

###24573586
OBJECTIVE	To evaluate the occurrence of reflux from the great saphenous vein by color Doppler ultrasonography in subjects undergoing treatment of insufficiency of the saphenofemoral junction by simple ligation or ligation with section of the saphenous arch .
METHODS	We performed 60 operations ( in 45 subjects ) of varicose insufficiency of the saphenofemoral junction ( SFJ ) , belonging to the CEAP clinical classification of 2-5 , who were randomly divided into two groups .
METHODS	A group called C , with ligature and section of the saphenous arch , and a group called L , with simple ligation of the saphenous vein and no sectioning of its arch .
METHODS	We then investigated the occurrence of reflux from the great saphenous vein in groups C and L through postoperative color Doppler ultrasonography at intervals of six months to one year .
RESULTS	Of the 60 members submitted to the approach of the saphenous arch , 57 were evaluated by postoperative doppler ultrasound , since two subjects ( three limbs ) did not return and were excluded from the study .
RESULTS	The mean age was 54 years , with 93 % females and predominance of CEAP classification 2 in 60.5 % .
RESULTS	Of the 57 operations for the treatment of reflux of the saphenous arch , 43.9 % had reflux postoperatively ,14.1 % in group C and 29.8 % in group L ( p < 0,05 ) .
RESULTS	The relative risk of reflux of the saphenous arch in group L was 2.03 times higher compared with group C.
CONCLUSIONS	the section of the arch of the great saphenous vein causes less postoperative reflux than simple ligation in treatment of insufficiency of the great saphenous vein .

###25024660
OBJECTIVE	To examine the measurement differences in sleep and EEG arousal statistics between the American Academy of Sleep Medicine ( AASM ) recommended EEG montage ( F4-M1 , C4-M1 , O2-M1 ) and acceptable EEG montage ( Fz-Cz , C4-M1 , Oz-Cz ) .
METHODS	Prospective , blinded , randomized comparison .
METHODS	Australian clinical sleep laboratory in a tertiary hospital .
METHODS	50 consecutive patients undertaking polysomnography ( PSG ) for the clinical suspicion of sleep disordered breathing .
METHODS	N/A .
RESULTS	Patient EEGs were recorded using both the AASM recommended and acceptable EEG montages during the PSG .
RESULTS	Two scorers were used to examine the difference in PSG statistics using the two EEG montages .
RESULTS	The scorers analyzed the 50 studies using the two EEG montages .
RESULTS	Ten of the studies were scored twice for each montage by each scorer to calculate intra-scorer and inter-scorer agreement .
RESULTS	No statistically significant differences were observed between the PSG statistics of the recommended and acceptable EEG montages .
RESULTS	The recommended EEG montage had greater inter-scorer agreement but no difference in intra-scorer agreement .
CONCLUSIONS	This study demonstrates that the two EEG montages endorsed by the AASM Manual produce similar sleep and EEG arousal statistics .

###25547786
OBJECTIVE	It is recommended that treatments that include clarithromycin should be avoided in eradication of Helicobacter pylori ( HP ) in cases where clarithromycin resistance is higher than 20 % .
OBJECTIVE	We aimed to compare levofloxacin - and moxifloxacin-based triple therapies with standard treatment and with each other in eradication of helicobacter pylori as first-line therapy .
METHODS	Patients were randomized prospectively as three groups .
METHODS	There were 102 patients in the levofloxacin group , 101 patients in the moxifloxacin group , and 103 patients in the standard treatment group .
METHODS	The patients received levofloxacin 500 mg daily , amoxicillin 1 g b.i.d. and lansoprazole 30 mg b.i.d. for ten days ( LAL ) in the levofloxacin group ; moxifloxacin 400 mg daily , amoxicillin 1 g b.i.d. and lansoprazole 30 mg b.i.d. ( MAL ) in the moxifloxacin group ; and clarithromycin 500 mg b.i.d. , amoxicillin 1 g b.i.d. and lansoprazole 30 mg b.i.d. ( CAL ) in the standard treatment group .
METHODS	At post-treatment week 6 , HP was checked by using stool antigen test .
RESULTS	In the eradication of Helicobacter pylori , the success rate as determined by per protocol ( PP ) analysis was 92 % in the LAL group , 91.8 % in the MAL group , and 82.4 % in the CAL group .
RESULTS	A statistically significant difference was found in the LAL and MAL groups compared to the CAL group ( p < 0.05 ) .
RESULTS	There was no difference between the LAL and MAL groups .
CONCLUSIONS	It was determined that levofloxacin - and moxifloxacin-based triple therapies were more effective than the standard treatment in first-line setting in the eradication of Helicobacter pylori .
CONCLUSIONS	In addition , no difference was found between levofloxacin - and moxifloxacin-based triple therapies .
CONCLUSIONS	Currently observed high efficacy may be evaluated in treatment .
CONCLUSIONS	Although quinolon resistance is not considered a major problem , it appears to be a factor that may reduce treatment success over a period of time .

###24254567
BACKGROUND	Bone tunnel enlargement after anterior cruciate ligament ( ACL ) reconstruction is well documented in the literature .
BACKGROUND	The cause of this tunnel enlargement is unclear , but is thought to be multifactorial , with mechanical and biological factors playing a role .
OBJECTIVE	The aim of this prospective study was to evaluate how the different techniques may affect the bone tunnel enlargement and clinical outcome .
METHODS	Forty-five consecutive patients undergoing ACL reconstruction with autologous doubled semitendinosus and gracilis tendons entered this study .
METHODS	They were randomly assigned to enter group A ( In-Out technique , with cortical fixation and Interference screw ) and group B ( Out-In technique , metal cortical fixation on the femour and tibia ) .
METHODS	At a mean follow-up of 10 months , all the patients underwent CT scan exam to evaluate the post-operative diameters of both femoral and they underwent tibial tunnels clinical examination after 24 months .
RESULTS	The mean femoral tunnel diameter increased significantly from 9.050.3 mm to 10.012.3 mm in group A and from 9.040.8 mm to 9.31.12 mm in group B.
RESULTS	The mean increase in femoral tunnel diameters observed in group A was significantly higher than that observed in group B ( p < 0.05 ) The mean tibial tunnel diameter increased significantly from 9.030.04 mm to 10.682.5 mm in group A and from 9.040.03 mm to 10.0.78 mm in group B.
RESULTS	The mean increase in tibial tunnel diameters observed in group A was significantly higher than that observed in group B ( p < 0.05 ) .
RESULTS	No clinical differences were found between two groups and no correlations between clinical and radiological results were found in any patients of both groups .
CONCLUSIONS	Results of the study suggest that different mechanical fixation devices could influence tunnel widening .
CONCLUSIONS	The lower stiffness of the fixation devices is probably responsible of the tunnel widening through the fixation devices 's micromotions in the femoral and tibial tunnels .

###24418042
BACKGROUND	Laboratory skills training is now required for general surgery residents .
BACKGROUND	The optimal method of teaching vascular anastomosis ( VA ) is not well defined .
BACKGROUND	Teaching VA skills one-on-one with a faculty instructor will result in a more rapid accumulation of skills than teaching in a large group setting .
METHODS	Residents were shown an instructional video on how to perform a VA using a standardized model ( cadaver saphenous vein and porcine aorta ) .
METHODS	Each resident then performed a baseline VA. .
METHODS	Sixteen first - and second-year surgical residents were then randomized to 2 VA teaching sessions that consisted of either 1 ) group teaching ( GT , 8 residents in a room with 1 faculty instructor circulating ) or 2 ) one-on-one teaching ( 1-on-1 , faculty member focused on individual resident ) .
METHODS	After each of these sessions , residents performed a standardized VA. .
METHODS	The anastomoses were video recorded .
METHODS	Performance was evaluated using a standardized scoring system by a separate expert who viewed the video recordings in a blinded fashion .
METHODS	Outcome measures included total errors , total time , global rating scale , and an anastomosis-specific end-product evaluation ( leak and passage of coronary dilator ) .
RESULTS	Overall , significant decreases in total errors ( 21 to 15 , P = 0.001 ) and time to complete anastomoses ( 42 to 38 min , P = 0.02 ) and an increase in global rating scales ( 7 to 11 , P = 0.003 ) were noted in both groups from baseline after 2 VA teaching session .
RESULTS	The 1-on-1 group demonstrated significantly greater improvement in terms of reduced anastomotic time ( 30 vs. 42 min , P = 0.007 ) and in reduction of errors ( 13 vs. 19 errors , P = 0.09 ) than the GT group .
CONCLUSIONS	The high-fidelity VA model is a useful tool for junior general surgery residents .
CONCLUSIONS	Both GT and 1-on-1 groups demonstrated significant improvement in total errors and time after only 2 sessions .
CONCLUSIONS	Greater improvement was noted using the 1-on-1 model .

###24945948
BACKGROUND	Preincisional analgesia is an antinociceptive treatment that prevents altered central excitability from high-intensity noxious stimuli .
BACKGROUND	To determine the analgesic efficacy of preoperative infiltration with bupivacaine for reduction mammaplasty , a randomized , double-blind , placebo-controlled trial was designed .
METHODS	Women with mammary hypertrophy were allocated randomly to one of two study groups .
METHODS	Patients in group I received preincision infiltration with bupivacaine into each breast after general anesthesia .
METHODS	Group II patients received similar injections of saline injection alone after general anesthesia .
RESULTS	Visual analogue pain score , verbal pain score , and short-form McGill Pain Questionnaire scores were higher in group II patients until 22 hours after surgery ( p < 0.008 ) .
RESULTS	Patients in the saline group had higher intravenous meperidine consumption for 22 hours postoperatively and solicited opioids before the patients in the bupivacaine group ( p < 0.001 ) .
RESULTS	The difference between groups was statistically significant .
CONCLUSIONS	Preincisional infiltration with bupivacaine results in reduced pain and lower postoperative opioid requirements in the early postoperative phase of pain following breast reduction .
METHODS	Therapeutic , I.

###24322182
OBJECTIVE	This study aims to investigate the efficacy and safety of oral fixed-dose combination of strontium ranelate 2 g/vitamin D 1000 IU daily vs strontium ranelate 2 g daily for correcting vitamin D insufficiency in osteoporosis .
METHODS	A 6-month international , randomized , double-blind , parallel-group , phase 3 study .
METHODS	A total of 518 men and postmenopausal women aged 50 years with primary osteoporosis ( T-score -2.5 s.d. ) and serum 25-hydroxyvitamin D ( 25 ( OH ) D ) > 22.5 nmol/l were included .
METHODS	Patients were allocated to strontium ranelate 2 g/vitamin D 1000 IU daily ( n = 413 ) or strontium ranelate 2 g daily ( n = 105 ) .
METHODS	The participants received calcium 1 g daily .
METHODS	The primary endpoint was serum 25 ( OH ) D at last post-baseline evaluation during 3 months .
RESULTS	Both groups were comparable at baseline .
RESULTS	Mean baseline of 25 ( OH ) D was 44.1 14.6 nmol/l .
RESULTS	After 3 months , the percentage of patients with 25 ( OH ) D 50 nmol/l was higher with strontium ranelate/vitamin D vs strontium ranelate ( 84 vs 44 % , P < 0.001 ; adjusted between-group odds ratio = 6.7 ; 95 % CI , 4.2-10 .9 ) .
RESULTS	The efficacy of the fixed-dose combination on 25 ( OH ) D was maintained at 6 months ( 86 vs 40 % , P < 0.001 ) .
RESULTS	Mean 25 ( OH ) D was 65.1 and 49.5 nmol/l , respectively , after 3 months and 66.9 and 45.4 nmol/l after 6 months .
RESULTS	Physical performance improved in both groups .
RESULTS	Falls were 17 and 20 % in the strontium ranelate/vitamin D and strontium ranelate groups respectively .
RESULTS	Parathyroid hormone levels were inversely correlated with 25 ( OH ) D. No clinically relevant differences in safety were observed .
CONCLUSIONS	This study confirms the efficacy and safety of fixed-dose combination of strontium ranelate 2 g/vitamin D 1000 IU for correction of vitamin D insufficiency in osteoporotic patients .

###25047675
BACKGROUND	CBP501 , a synthetic duodecapeptide , increases cisplatin influx into tumor cells through an interaction with calmodulin enhancing cisplatin cytotoxicity , and effects cell cycle progression by abrogating DNA repair at the G2 checkpoint .
BACKGROUND	In phase I clinical trials of CBP501 alone or in combination with cisplatin , the most common toxicity was infusion-related urticaria .
BACKGROUND	Activity of CBP501 plus cisplatin was observed in patients with ovarian cancer and mesothelioma , including some patients previously treated with cisplatin .
METHODS	Chemotherapy nave patients with unresectable MPM were stratified by histology and performance status , and randomized 2:1 to pemetrexed/cisplatin plus CBP501 25mg/m ( 2 ) IV ( Arm A ) or pemetrexed/cisplatin alone ( Arm B ) .
METHODS	The primary endpoint was progression free survival ( PFS ) at 4 months .
RESULTS	65 patients were randomized , and 63 were treated .
RESULTS	Patient characteristics in the two arms were balanced .
RESULTS	Based on independent radiology review of the treated population , 25/40 patients ( 63 % ) in Arm A and 9/23 ( 39 % ) in Arm B had PFS4mo ; the median PFS was 5.1 mo ( 95 % CI , 3.9 , 6.5 ) vs 3.4 mo ( 2.5 , 6.7 ) .
RESULTS	Median OS was 13.3 mo ( 9.2 , 16.3 ) in Arm A and 12.8 ( 6.5 , 16.1 ) in Arm B. Adverse events were not different than expected from standard chemotherapy , and comparable in the two arms , aside from infusion reactions which occurred in 70 % of patients treated with CBP501 .
CONCLUSIONS	While this randomized phase II trial met its primary endpoint of PFS at 4 months , other parameters such as response rate and overall survival suggest that the addition of CBP501 does not improve the efficacy of standard chemotherapy for MPM .

###25540041
BACKGROUND	The home food environment is an important setting for the development of dietary patterns in childhood .
BACKGROUND	Interventions that support parents to modify the home food environment for their children , however , may also improve parent diet .
BACKGROUND	The purpose of this study was to assess the impact of a telephone-based intervention targeting the home food environment of preschool children on the fruit and vegetable consumption of parents .
METHODS	In 2010 , 394 parents of 3-5 year-old children from 30 preschools in the Hunter region of Australia were recruited to this cluster randomised controlled trial and were randomly assigned to an intervention or control group .
METHODS	Intervention group parents received four weekly 30-minute telephone calls and written resources .
METHODS	The scripted calls focused on ; fruit and vegetable availability and accessibility , parental role-modelling , and supportive home food routines .
METHODS	Two items from the Australian National Nutrition Survey were used to assess the average number of serves of fruit and vegetables consumed each day by parents at baseline , and 2 - , 6 - , 12 - , and 18-months later , using generalised estimating equations ( adjusted for baseline values and clustering by preschool ) and an intention-to-treat-approach .
RESULTS	At each follow-up , vegetable consumption among intervention parents significantly exceeded that of controls .
RESULTS	At 2-months the difference was 0.71 serves ( 95 % CI : 0.58-0 .85 , p < 0.0001 ) , and at 18-months the difference was 0.36 serves ( 95 % CI : 0.10-0 .61 , p = 0.0067 ) .
RESULTS	Fruit consumption among intervention parents was found to significantly exceed consumption of control parents at the 2 -,12 - and 18-month follow-up , with the difference at 2-months being 0.26 serves ( 95 % CI : 0.12-0 .40 , p = 0.0003 ) , and 0.26 serves maintained at 18-months , ( 95 % CI : 0.10-0 .43 , p = 0.0015 ) .
CONCLUSIONS	A four-contact telephone-based intervention that focuses on changing characteristics of preschoolers ' home food environment can increase parents ' fruit and vegetable consumption .
CONCLUSIONS	( ANZCTR12609000820202 ) .

###25349296
OBJECTIVE	We previously demonstrated that 48 % of patients with pain at sites of previously irradiated bone metastases benefit from reirradiation .
OBJECTIVE	It is unknown whether alleviating pain also improves patient perception of quality of life ( QOL ) .
METHODS	We used the database of a randomized trial comparing radiation treatment dose fractionation schedules to evaluate whether response , determined using the International Consensus Endpoint ( ICE ) and Brief Pain Inventory pain score ( BPI-PS ) , is associated with patient perception of benefit , as measured using the European Organisation for Resesarch and Treatment of Cancer ( EORTC ) Quality of Life Questionnaire Core 30 ( QLQ-C30 ) and functional interference scale of the BPI ( BPI-FI ) .
METHODS	Evaluable patients completed baseline and 2-month follow-up assessments .
RESULTS	Among 850 randomly assigned patients , 528 were evaluable for response using the ICE and 605 using the BPI-PS .
RESULTS	Using the ICE , 253 patients experienced a response and 275 did not .
RESULTS	Responding patients had superior scores on all items of the BPI-FI ( ie , general activity , mood , walking ability , normal work , relations with other people , sleep , and enjoyment of life ) and improved QOL , as determined by scores on the EORTC QLQ-C30 scales of physical , role , emotional and social functioning , global QOL , fatigue , pain , and appetite .
RESULTS	Similar results were obtained using the BPI-PS ; observed improvements were typically of lesser magnitude .
CONCLUSIONS	Patients responding to reirradiation of painful bone metastases experience superior QOL scores and less functional interference associated with pain .
CONCLUSIONS	Patients should be offered re-treatment for painful bone metastases in the hope of reducing pain severity as well as improving QOL and pain interference .

###24910870
OBJECTIVE	To evaluate wrinkle improvement and safety of a novel cosmetic dissolving microneedle patches loaded with two active compounds with different hydrophilicities , namely ascorbic acid and retinyl retinoate .
METHODS	Clinical studies were performed on 24 Korean women for 12 weeks .
METHODS	Patients in group A were treated with retinyl retinoate-loaded dissolving microneedle patches on the left eye crow 's feet area , and patients in group B were treated with ascorbic acidloaded patches on the right eye crow 's feet area twice daily .
METHODS	Wrinkle improvement was evaluated by skin Visiometer SV 600 .
RESULTS	Both the retinyl retinoate - and ascorbic acid-loaded dissolving microneedle patches demonstrated statistically significant differences in all Visiometer R-values ( P < 0.05 ) .
RESULTS	In particular , highly significant differences were shown at R1 ( skin roughness ) and R5 ( arithmetic average roughness ) ( P < 0.001 ) .
RESULTS	Also , there were no side effects such as allergies or irritant contact dermatitis .
CONCLUSIONS	Retinyl retinoate and ascorbic acid were successfully loaded into dissolving microneedles and used to produce novel cosmetic patches .
CONCLUSIONS	These novel patches can be used efficiently in cosmetics given their patient usability , safety and effectiveness in wrinkle improvement .

###24456510
OBJECTIVE	To determine whether fitness-center attendance established with the provision of weekly monetary incentives persisted after the discontinuation , or decreased frequency , of incentives .
METHODS	One hundred seventeen first-year college students participated during the 2011-2012 academic year .
METHODS	A randomized controlled trial with control , discontinued-incentive , and continued-incentive conditions was conducted .
METHODS	During fall semester , students in incentive conditions received weekly monetary payments for meeting fitness-center attendance goals .
METHODS	During spring semester , discontinued-incentive condition participants no longer received incentives , whereas continued-incentive condition participants received payments on a variable-interval schedule .
METHODS	ID-card attendance records tracked fitness-center attendance .
RESULTS	Goal completion decreased from 63 % in the incentive groups during the fall semester to 3 % in the discontinued-incentive condition , and 39 % in the continued-incentive condition during the spring semester .
RESULTS	There was not a significant interaction between condition and body mass index change , F ( 6 , 332 ) = 0.67 , p = .68 .
CONCLUSIONS	Incentive discontinuation resulted in students no longer meeting fitness-center attendance goals .
CONCLUSIONS	A variable-interval reward schedule better maintained attendance .

###25396266
BACKGROUND	Statins have a beneficial effect on bone mineral density ( BMD ) and lean mass in some studies of HIV-uninfected adults ; however , this has never been investigated in the setting of HIV infection .
METHODS	HIV-infected individuals on stable antiretroviral therapy with a low-density lipoprotein cholesterol level of 130 mg/dl or less and evidence of heightened immune activation or inflammation were randomized to rosuvastatin 10 mg daily or placebo for 96 weeks .
METHODS	This was a prespecified interim analysis at 48 weeks .
METHODS	Between-group and within-group differences were compared ; multivariable regression models were constructed .
RESULTS	Seventy-two individuals were randomized to statin therapy and 75 to placebo .
RESULTS	Modest 48-week relative increases in trochanter BMD [ 0.9 % ; 95 % confidence interval ( 95 % CI ) -0.9 to 0.6 ] and total hip BMD ( 0.6 % ; 95 % CI 0.0-1 .1 ) in the statin arm were significantly greater than placebo ( P < 0.05 ) .
RESULTS	The relationship between statin use and total hip BMD change was robust to adjustment of age , sex , race and smoking status ( P = 0.02 ) and strengthened by inclusion of baseline ( P = 0.01 ) and week 48 change in soluble tumour necrosis factor - receptor ( sTNFR ) -1 ( P = 0.009 ) .
RESULTS	Relative increases in total body , trunk and limb fat were similar between statin and placebo arms ( P0 .58 ) .
RESULTS	Although a significant gain in leg lean mass was seen in the statin arm , this was not significantly different compared with placebo ( P = 0.36 ) .
CONCLUSIONS	The improvements seen in total hip BMD after 48 weeks of rosuvastatin therapy support further potential benefits of statin therapy in HIV , beyond a reduction of cardiovascular risk .

###24799157
BACKGROUND	Mobilization-Observation-Behavior-Intensity-Dementia-2 ( MOBID-2 ) pain scale is a staff-administered pain tool for patients with dementia .
BACKGROUND	This study explores MOBID-2 's test-retest reliability , measurement error and responsiveness to change .
METHODS	Analyses are based upon data from a cluster randomized trial including 352 patients with advanced dementia from 18 Norwegian nursing homes .
METHODS	Test-retest reliability between baseline and week 2 ( n = 163 ) , and weeks 2 and 4 ( n = 159 ) was examined in patients not expected to change ( controls ) , using intraclass correlation coefficient ( ICC2 .1 ) , standard error of measurement ( SEM ) and smallest detectable change ( SDC ) .
METHODS	Responsiveness was examined by testing six priori-formulated hypotheses about the association between change scores on MOBID-2 and other outcome measures .
RESULTS	ICCs of the total MOBID-2 scores were 0.81 ( 0-2 weeks ) and 0.85 ( 2-4 weeks ) .
RESULTS	SEM and SDC were 1.9 and 3.1 ( 0-2 weeks ) and 1.4 and 2.3 ( 2-4 weeks ) , respectively .
RESULTS	Five out of six hypotheses were confirmed : MOBID-2 discriminated ( p < 0.001 ) between change in patients with and without a stepwise protocol for treatment of pain ( SPTP ) .
RESULTS	Moderate association ( r = 0.35 ) was demonstrated with Cohen-Mansfield Agitation Inventory , and no association with Mini-Mental State Examination , Functional Assessment Staging and Activity of Daily Living .
RESULTS	Expected associations between change scores of MOBID-2 and Neuropsychiatric Inventory - Nursing Home version were not confirmed .
CONCLUSIONS	The SEM and SDC in connection with the MOBID-2 pain scale indicate that the instrument is responsive to a decrease in pain after a SPTP .
CONCLUSIONS	Satisfactory test-retest reliability across test periods was demonstrated .
CONCLUSIONS	Change scores 3 on total and subscales are clinically relevant and are beyond measurement error .

###24767614
OBJECTIVE	To test whether a brief mindfulness meditation training intervention buffers self-reported psychological and neuroendocrine responses to the Trier Social Stress Test ( TSST ) in young adult volunteers .
OBJECTIVE	A second objective evaluates whether pre-existing levels of dispositional mindfulness moderate the effects of brief mindfulness meditation training on stress reactivity .
METHODS	Sixty-six ( N = 66 ) participants were randomly assigned to either a brief 3-day ( 25-min per day ) mindfulness meditation training or an analytic cognitive training control program .
METHODS	All participants completed a standardized laboratory social-evaluative stress challenge task ( the TSST ) following the third mindfulness meditation or cognitive training session .
METHODS	Measures of psychological ( stress perceptions ) and biological ( salivary cortisol , blood pressure ) stress reactivity were collected during the social evaluative stress-challenge session .
RESULTS	Brief mindfulness meditation training reduced self-reported psychological stress reactivity but increased salivary cortisol reactivity to the TSST , relative to the cognitive training comparison program .
RESULTS	Participants who were low in pre-existing levels of dispositional mindfulness and then received mindfulness meditation training had the greatest cortisol reactivity to the TSST .
RESULTS	No significant main or interactive effects were observed for systolic or diastolic blood pressure reactivity to the TSST .
CONCLUSIONS	The present study provides an initial indication that brief mindfulness meditation training buffers self-reported psychological stress reactivity , but also increases cortisol reactivity to social evaluative stress .
CONCLUSIONS	This pattern may indicate that initially brief mindfulness meditation training fosters greater active coping efforts , resulting in reduced psychological stress appraisals and greater cortisol reactivity during social evaluative stressors .

###25341548
OBJECTIVE	Palmar-plantar erythrodysesthesia ( PPE ) is a common chemotherapy and anti-VEGF multi-kinase inhibitor class-related toxicity that often results in debilitating skin changes and often limits the use of active anti-cancer regimens .
OBJECTIVE	Mechanistic and anecdotal clinical evidence suggested that topical application of sildenafil cream may help reduce the severity of PPE .
OBJECTIVE	Therefore , we conducted a randomized , double-blind , placebo-controlled pilot study to evaluate the feasibility , safety and efficacy of topical sildenafil cream for the treatment of PPE .
METHODS	Eligible subjects were required to have grade 1-3 PPE associated with either capecitabine or sunitinib .
METHODS	Subjects were randomized to receive 1 % topical sildenafil cream to the left extremities or right extremities and placebo cream on the opposite extremity .
METHODS	Two times per day , 0.5 mL of cream was applied to each affected hand/foot .
METHODS	The primary endpoint was improvement in PPE grading at any point on study .
METHODS	Clinical assessments were evaluated by NCI-CTC 4.0 grading and patient self-reported pain .
RESULTS	Ten subjects were enrolled , nine were evaluable for safety and efficacy .
RESULTS	Five of nine subjects reported some improvement in foot pain and three of eight subjects for hand pain improvement .
RESULTS	One of these subjects noted specific improvement in tactile function .
RESULTS	No treatment-related toxicities were observed .
CONCLUSIONS	In this limited , single-center study , topical cream containing 1 % sildenafil is feasible to administer , is well-tolerated , and may mitigate PPE-related symptoms due to anti-cancer therapeutic agents .
CONCLUSIONS	Further validation is necessary .

###25817200
OBJECTIVE	We set out to compare emergency medicine residents ' intubating times and success rates for direct laryngoscopy ( DL ) , GlideScope-assisted intubation ( GS ) , and the Supraglottic Airway Laryngopharyngeal Tube ( SALT ) airway with and without biohazard gear .
METHODS	Each resident passed through 2 sets of 3 testing stations ( DL , GS , SALT ) in succession , intubating Laerdal mannequin heads with the 3 modalities after randomization to start with or without biohazard gear .
RESULTS	Thirty-seven residents participated , and 27 were male ( 73 % ) ; 14 ( 37.8 % ) had prior experience intubating in biohazard suits .
RESULTS	There was a statistically significant difference in those who had prior intubation experience between DL ( 37 , 100 % ) , GS ( 32 , 86.5 % ) , and SALT ( 12 , 32.4 % ) ( P < .001 ) and in median time to intubation ( 48 seconds , no suit ; 57 seconds , with suits ) ( P = .03 ) .
RESULTS	There was no statistically significant difference between the overall times to intubate for the 3 devices .
RESULTS	First-pass success was highest for DL ( 91.2 % , no suit ; 83.7 % , suit ) followed by GS ( 89 % , no suit ; 78.3 % , suit ) and SALT ( 51 % , no suit ; 67.6 % , suit ) .
CONCLUSIONS	A minority of participants had prior experience intubating in biohazard suits .
CONCLUSIONS	Use of biohazard suits extends time to successful intubation .
CONCLUSIONS	There was no difference in time to intubation for the 3 devices , but first-pass success was highest for DL ( with or without biohazard gear ) .

###25493968
OBJECTIVE	Delirium is common during critical illness and associated with adverse outcomes .
OBJECTIVE	We compared characteristics and outcomes of delirious and nondelirious patients enrolled in a multicenter trial comparing protocolized sedation with protocolized sedation plus daily sedation interruption .
METHODS	Randomized trial .
METHODS	Sixteen North American medical and surgical ICUs .
METHODS	Four hundred thirty critically ill , mechanically ventilated adults .
METHODS	All patients had hourly titration of opioid and benzodiazepine infusions using a validated sedation scale .
METHODS	For patients in the interruption group , infusions were resumed , if indicated , at half of previous doses .
METHODS	Delirium screening occurred daily ; positive screening was defined as an Intensive Care Delirium Screening Checklist score of 4 or more at any time .
RESULTS	Delirium was diagnosed in 226 of 420 assessed patients ( 53.8 % ) .
RESULTS	Coma was identified in 32.7 % of delirious compared with 22.7 % of nondelirious patients ( p = 0.03 ) .
RESULTS	The median time to onset of delirium was 3.5 days ( interquartile range , 2-7 ) , and the median duration of delirium was 2 days ( interquartile range , 1-4 ) .
RESULTS	Delirious patients were more likely to be male ( 61.1 % vs 46.6 % ; p = 0.005 ) , have a surgical/trauma diagnosis ( 21.2 % vs 11.0 % ; p = 0.030 ) , and history of tobacco ( 31.5 % vs 16.2 % ; p = 0.002 ) or alcohol use ( 34.6 % vs 20.9 % ; p = 0.009 ) .
RESULTS	Patients with positive delirium screening had longer duration of ventilation ( 13 vs 7 d ; p < 0.001 ) , ICU stay ( 12 vs 8 d ; p < 0.0001 ) , and hospital stay ( 24 vs 15 d ; p < 0.0001 ) .
RESULTS	Delirious patients were more likely to be physically restrained ( 86.3 % vs 76.7 % ; p = 0.014 ) and undergo tracheostomy ( 34.6 % vs 15.5 % ; p < 0.0001 ) .
RESULTS	Antecedent factors independently associated with delirium onset were restraint use ( hazard ratio , 1.87 ; 95 % CI , 1.33-2 .63 ; p = 0.0003 ) , antipsychotic administration ( hazard ratio , 1.67 ; 95 % CI , 1.005-2 .767 ; p = 0.047 ) , and midazolam dose ( hazard ratio , 0.998 ; 95 % CI , 0.997-1 .0 ; p = 0.049 ) .
RESULTS	There was no difference in delirium prevalence or duration between the interruption and control groups .
CONCLUSIONS	In mechanically ventilated adults , delirium was common and associated with longer duration of ventilation and hospitalization .
CONCLUSIONS	Physical restraint was most strongly associated with delirium .

###24856027
BACKGROUND	The administration of intravenous fluid remains the cornerstone treatment for the prevention of contrast-induced acute kidney injury .
BACKGROUND	However , no well-defined protocols exist to guide fluid administration in this treatment .
BACKGROUND	We aimed to establish the efficacy of a new fluid protocol to prevent contrast-induced acute kidney injury .
METHODS	In this randomised , parallel-group , comparator-controlled , single-blind phase 3 trial , we assessed the efficacy of a new fluid protocol based on the left ventricular end-diastolic pressure for the prevention of contrast-induced acute kidney injury in patients undergoing cardiac catheterisation .
METHODS	The primary outcome was the occurrence of contrast-induced acute kidney injury , which was defined as a greater than 25 % or greater than 05 mg/dL increase in serum creatinine concentration .
METHODS	Between Oct 10 , 2010 , and July 17 , 2012 , 396 patients aged 18 years or older undergoing cardiac catheterisation with an estimated glomerular filtration rate of 60 mL/min per 173 m ( 2 ) or less and one or more of several risk factors ( diabetes mellitus , history of congestive heart failure , hypertension , or age older than 75 years ) were randomly allocated in a 1:1 ratio to left ventricular end-diastolic pressure-guided volume expansion ( n = 196 ) or the control group ( n = 200 ) who received a standard fluid administration protocol .
METHODS	Four computer-generated concealed randomisation schedules , each with permuted block sizes of 4 , were used for randomisation , and participants were allocated to the next sequential randomisation number by sealed opaque envelopes .
METHODS	Patients and laboratory personnel were masked to treatment assignment , but the physicians who did the procedures were not masked .
METHODS	Both groups received intravenous 09 % sodium chloride at 3 mL/kg for 1 h before cardiac catheterisation .
METHODS	Analyses were by intention to treat .
METHODS	Adverse events were assessed at 30 days and 6 months and all such events were classified by staff who were masked to treatment assignment .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01218828 .
RESULTS	Contrast-induced acute kidney injury occurred less frequently in patients in the left ventricular end-diastolic pressure-guided group ( 67 % [ 12/178 ] ) than in the control group ( 163 % [ 28/172 ] ; relative risk 041 , 95 % CI 022-079 ; p = 0005 ) .
RESULTS	Hydration treatment was terminated prematurely because of shortness of breath in three patients in each group .
CONCLUSIONS	Left ventricular end-diastolic pressure-guided fluid administration seems to be safe and effective in preventing contrast-induced acute kidney injury in patients undergoing cardiac catheterisation .
BACKGROUND	Kaiser Permanente Southern California regional research committee grant .

###25212990
BACKGROUND	Total knee arthroplasty ( TKA ) is commonly performed using a tourniquet .
BACKGROUND	However , some studies have reported that several complications were associated with the use of a tourniquet in TKA .
BACKGROUND	In this study we investigate whether the limited use of a tourniquet in TKA would reduce complications and facilitate postoperative recovery .
METHODS	Sixty patients were randomly divided into two groups ( 30 cases/group ) : group A using the tourniquet throughout the surgical procedure , and group B using the tourniquet starting from the cementation to the completion of the procedure .
METHODS	Operation time , total measured blood loss , and incidence of complications were all recorded .
RESULTS	There was no significant difference in operation time , total measured blood loss , and hemoglobin concentration between the two groups .
RESULTS	Incidence of postoperative complications in group B was significantly decreased in comparison to that in group A.
RESULTS	The limb circumference at 10 cm above the superior patellar pole or below the inferior patellar pole and the pain score in group B were significantly decreased compared with that in group A at any time point .
RESULTS	Range of motion in group B was significantly increased at three and 5 days postoperatively in comparison to that in group A.
CONCLUSIONS	The limited use of a tourniquet in TKA provides the benefit of decreased limb swelling and knee joint pain while not compromising the operation time or blood loss and recovery .
METHODS	Level I ( Therapeutic ) .
BACKGROUND	NCT02102581 .

###24366220
BACKGROUND	The relation between visceral fat accumulation and development of cardiovascular and metabolic disorders has been demonstrated .
BACKGROUND	The aim of this study was to determine the relationship between a new ultrasound visceral fat thickness ( VFT ) measurement and clinical and anthropometric data in a consecutive series of obese patients .
METHODS	Fifty-five consecutive male obese patients underwent ultrasound evaluation and metabolic and anthropometric parameters determination at baseline and after 3 weeks of a very low-calorie diet ( VLCD ) therapy .
METHODS	The new ultrasound measurement , the thickness of the fat between the aorta and the superior mesenteric artery ( AMFT ) , was determined along with the maximum thickness of preperitoneal fat and the global VFT .
RESULTS	AMFT showed a better correlation than VFT and preperitoneal fat with all anthropometric and metabolic parameters , both at baseline and after VLCD regimen .
RESULTS	At baseline , patients in the middle and high AMFT and VFT tertiles had a significantly higher prevalence of metabolic diseases with respect to AMFT and VFT low tertile patients , whereas after VLCD period , AMFT only showed significant difference within tertiles .
RESULTS	The odds ratios for the various metabolic diseases were higher in the middle and high AMFT tertiles than those in the middle and high VFT tertiles , remaining significant after adjustment for age , body mass index and VLCD regimen only in the middle and high AMFT tertiles .
CONCLUSIONS	The ultrasonographic AMFT evaluation is strongly correlated to the presence of metabolic syndrome and could be a valuable tool to predict metabolic diseases and associated cardiovascular risks in men .

###24739593
BACKGROUND	Antiplatelet drugs are recommended for patients with acute noncardioembolic stroke .
BACKGROUND	However , few randomized clinical trials have investigated the safety and efficacy of dual antiplatelet therapy for these patients .
BACKGROUND	The aim of this study was to evaluate the effects of treatment with clopidogrel and aspirin ( combination therapy ) and aspirin alone ( monotherapy ) on neurologic deterioration , platelet activation , and other short-term outcomes in patients with acute large-artery atherosclerosis stroke .
METHODS	Altogether 574 patients with acute ( 2days ) large-artery atherosclerosis stroke were randomly assigned to receive either combined clopidogrel and aspirin or aspirin alone .
METHODS	Platelet aggregation and platelet-leukocyte aggregation studies were performed at days 1 and 30 .
METHODS	Primary outcomes including recurrent ischemic stroke , neurologic deterioration , periphery vascular events , and myocardial infarction were monitored .
METHODS	Safety endpoints were hemorrhagic episodes and death .
RESULTS	The prevalence of neurologic deterioration and recurrent ischemic stroke were lower in patients in the combination therapy group than in those of the monotherapy group ( 3.52 % versus 9.78 % and 1.76 % versus 6.29 % , respectively ) .
RESULTS	At day 30 of treatment , the platelet aggregations and platelet-leukocyte aggregates were lower in patients who were treated with clopidogrel and aspirin than in patients given aspirin alone ( P < .001 ) .
CONCLUSIONS	For patients with acute large-artery atherosclerosis stroke , treatment with clopidogrel and aspirin for 1month provided significantly greater inhibition of platelet activity than aspirin alone .
CONCLUSIONS	Thus , dual therapy can be safer and more effective in reducing ischemic stroke recurrence and neurologic deterioration .

###25115308
BACKGROUND	Patients with cervical radiculopathy often have neck - and arm pain , neurological changes , activity limitations and difficulties in returning to work .
BACKGROUND	Most patients are not candidates for surgery but are often treated with different conservative approaches and may be sick-listed for long periods .
BACKGROUND	The purpose of the current study is to compare the effectiveness of neck-specific training versus prescribed physical activity .
METHODS	The current protocol is a two armed intervention randomised clinical trial comparing the outcomes of patients receiving neck specific training or prescribed physical activity .
METHODS	A total of 144 patients with cervical radiculopathy will be randomly allocated to either of the two interventions .
METHODS	The interventions will be delivered by experienced physiotherapists and last 14 weeks .
METHODS	The primary outcome variable is neck - and arm pain intensity measured with a Visual Analogue Scale accompanied with secondary outcome measures of impairments and subjective health measurements collected before intervention and at 3 , 6 , 12 and 24 months after base-line assessment .
CONCLUSIONS	We anticipate that the results of this study will provide evidence to support recommendations as to the effectiveness of conservative interventions for patients with cervical radiculopathy .
BACKGROUND	ClinicalTrials.gov identifier : NCT01831271 .

###25300460
BACKGROUND	This study is a European multicentre , randomised , double-blind , placebo-controlled trial investigating the efficacy and safety of nilvadipine as a disease course modifying treatment for mild-to-moderate Alzheimer 's disease ( AD ) in a phase III study that will run for a period of 82weeks with a treatment period of 78weeks .
METHODS	Adult patients , males and females over 50years with mild-to-moderate AD as defined by the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer 's disease and Related Disorders Association ( NINCDS-ADRDA ) criteria , will be included in the study .
METHODS	It aims to recruit a total of 500 patients with AD ; 250 in the nilvadipine group and 250 in the placebo group .
METHODS	Participants will be randomised to receive nilvadipine , an 8mg overencapsulated , sustained release capsule , or a matching overencapsulated placebo ( sugar pill ) for a period of 78weeks of treatment .
METHODS	The primary efficacy outcome measure in this study is the change in cognitive function as assessed by the Alzheimer 's disease Assessment Scale ( ADAS-Cog 12 ) from baseline to the end of treatment duration ( 78weeks ) .
METHODS	There are two key secondary outcome measures , the Clinical Dementia Rating Scale Sum of Boxes ( CDR-sb ) and the Disability Assessment for Dementia ( DAD ) .
METHODS	If a statistically significant effect is seen in the primary outcome , CDR-sb will be considered to be a coprimary end point and only the DAD will contribute to the secondary outcome analysis .
BACKGROUND	The study and all subsequent amendments have received ethical approval within each participating country according to national regulations .
BACKGROUND	Each participant will provide written consent to participate in the study .
BACKGROUND	All participants will remain anonymised throughout and the results of the study will be published in an international peer-reviewed journal .
BACKGROUND	EUDRACT Reference Number : 2012-002764-27 .

###24961183
OBJECTIVE	Mirror therapy ( MT ) has been recommended as a simple , inexpensive approach to treat motor dysfunction .
OBJECTIVE	The use of a mesh glove ( MG ) was suggested to normalize muscle tone that ameliorates motor impairment .
OBJECTIVE	Combining two efficient treatment protocols might maximize the benefits from training .
OBJECTIVE	This study investigated the effects of MT combined with MG ( MG+MT ) versus MT alone on motor performance and daily function after stroke .
METHODS	Sixteen patients with chronic unilateral stroke were recruited .
METHODS	A randomized two-group pretest and posttest design was used to randomly assign participants to MG+MT or MT groups .
METHODS	MT involves repetitive bimanual , symmetrical movement practice in which the individual moves the affected limb as much as she/he could while watching the reflective illusion of the unaffected limb 's movements from a mirror .
METHODS	The MG+MT group wore a MG on the affected hand during the MT. The Modified Ashworth scale of muscle spasticity ( MAS ) , Action Research Arm Test ( ARAT ) , Box and Block Test ( BBT ) , and Functional Independence Measure ( FIM ) were administered to evaluate spasticity , and motor and daily function .
RESULTS	The results for the BBT ( p = 0.013 ) , total scores ( p = 0.031 ) , grasping subscales ( p = 0.036 ) of ARAT , and FIM transfer scores ( p = 0.013 ) presented significantly large effects in favor of the MG+MT group .
CONCLUSIONS	Combining MG with MT significantly improves manual dexterity , grasping , and transfer performance .
CONCLUSIONS	Adding the MG component into the MT likely increased the richness of sensory input and improved the movement performance more than MT alone .

###24341382
BACKGROUND	Inhaled lipopolysaccharide ( LPS ) induces a dose-dependent , acute neutrophilic response in the airways of healthy volunteers that can be quantified in induced sputum .
BACKGROUND	Chemokines , such as CXCL1 and CXCL8 , play an important role in neutrophilic inflammation in the lung through the activation of CXCR2 and small molecule antagonists of these receptors have now been developed .
BACKGROUND	We investigated the effect of AZD8309 , a CXCR2 antagonist , compared with placebo on LPS-induced inflammation measured in sputum of healthy volunteers .
METHODS	Twenty healthy subjects were randomized in a double-blind placebo-controlled , cross-over study .
METHODS	AZD8309 ( 300 mg ) or placebo was dosed twice daily orally for 3 days prior to challenge with inhaled LPS and induced sputum was collected 6 h later .
RESULTS	Treatment with AZD8309 showed a mean 77 % reduction in total sputum cells ( p < 0.001 ) and 79 % reduction in sputum neutrophils ( p < 0.05 ) compared with placebo after LPS challenge .
RESULTS	There was also a reduction in neutrophil elastase activity ( p < 0.05 ) and CXCL1 ( p < 0.05 ) and trends for reductions in sputum macrophages ( 47 % ) , leukotriene B4 ( 39 % ) and CXCL8 ( 52 % ) .
CONCLUSIONS	AZD8309 inhibited LPS-induced inflammation measured in induced sputum of normal volunteers , indicating that this treatment may be useful in the treatment of neutrophilic diseases of the airways , such as COPD , severe asthma and cystic fibrosis .
BACKGROUND	NCT00860821 .

###25375109
BACKGROUND	To determine the effects of participation in Curtin University 's Activity , Food and Attitudes Program ( CAFAP ) , a community-based , family-centered behavioural intervention , on the physical activity , sedentary time , and healthy eating behaviours of overweight and obese adolescents .
METHODS	In this waitlist controlled clinical trial in Western Australia , adolescents ( n = 69 , 71 % female , mean age 14.1 ( SD 1.6 ) years ) and parents completed an 8-week intervention followed by 12 months of telephone and text message support .
METHODS	Assessments were completed at baseline , before beginning the intervention , immediately following the intervention , and at 3 - , 6 - , and 12 - months follow-up .
METHODS	The primary outcomes were physical activity and sedentary time assessed by accelerometers and servings of fruit , vegetables and junk food assessed by 3-day food records .
RESULTS	During the intensive 8-week intervention sedentary time decreased by -5.1 min/day/month ( 95 % CI : -11.0 , 0.8 ) which was significantly greater than the rate of change during the waitlist period ( p = .014 ) .
RESULTS	Moderate physical activity increased by 1.8 min/day/month ( 95 % CI : -0.04 , 3.6 ) during the intervention period , which was significantly greater than the rate of change during the waitlist period ( p = .041 ) .
RESULTS	Fruit consumption increased during the intervention period ( monthly incidence rate ratio ( IRR ) 1.3 , 95 % CI : 1.10 , 1.56 ) and junk food consumption decreased ( monthly IRR 0.8 , 95 % CI : 0.74 , 0.94 ) and these changes were different to those seen during the waitlist period ( p = .004 and p = .020 respectively ) .
CONCLUSIONS	Participating in CAFAP appeared to have a positive influence on the physical activity , sedentary and healthy eating behaviours of overweight and obese adolescents and many of these changes were maintained for one year following the intensive intervention .
BACKGROUND	Australia and New Zealand Clinical Trials Registry ACTRN12611001187932 .

###24795251
BACKGROUND	Diabetes is a leading cause of chronic kidney disease ( CKD ) worldwide .
BACKGROUND	Optimum glycaemic control in patients with type 2 diabetes is important to minimise the risk of microvascular and macrovascular complications and to slow the progression of CKD .
BACKGROUND	We assessed the efficacy and safety of empagliflozin as an add-on treatment in patients with type 2 diabetes and CKD .
METHODS	We did a phase 3 , randomised , double-blind , parallel-group , placebo-controlled trial at 127 centres in 15 countries .
METHODS	Patients with HbA1c of 7 % or greater to 10 % or less were eligible for inclusion .
METHODS	Patients with stage 2 CKD ( estimated glomerular filtration rate [ eGFR ] 60 to < 90 mL/min per 173 m ( 2 ) ; n = 290 ) were randomly assigned ( 1:1:1 ) to receive empagliflozin 10 mg or 25 mg or placebo once daily for 52 weeks .
METHODS	Patients with stage 3 CKD ( eGFR 30 to < 60 mL/min per 173 m ( 2 ) ; n = 374 ) were randomly assigned ( 1:1 ) to receive empagliflozin 25 mg or placebo for 52 weeks .
METHODS	Randomisation was done with a computer-generated random sequence and stratified by renal impairment , HbA1c , and background antidiabetes medication .
METHODS	Treatment assignment was masked from patients and investigators .
METHODS	The primary endpoint was change from baseline in HbA1c at week 24 by ANCOVA in the full analysis set .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01164501 .
RESULTS	In patients with stage 2 CKD , adjusted mean treatment differences versus placebo in changes from baseline in HbA1c at week 24 were -052 % ( 95 % CI -072 to -032 ) for empagliflozin 10 mg and -068 % ( -088 to -049 ) for empagliflozin 25 mg ( both p < 00001 ) .
RESULTS	In patients with stage 3 CKD , adjusted mean treatment difference versus placebo in change from baseline in HbA1c at week 24 was -042 % ( -056 to -028 ) for empagliflozin 25 mg ( p < 00001 ) .
RESULTS	In patients with stage 2 CKD , adverse events were reported over 52 weeks by 83 patients ( 87 % ) on placebo ( 15 severe [ 16 % ] and 11 serious [ 12 % ] ) , 86 ( 88 % ) on empagliflozin 10 mg ( six severe [ 6 % ] and six serious [ 6 % ] ) and 78 ( 80 % ) on empagliflozin 25 mg ( eight severe [ 8 % ] and seven serious [ 7 % ] ) .
RESULTS	In patients with stage 3 CKD , adverse events were reported over 52 weeks by 156 patients ( 83 % ) on placebo ( 15 severe [ 8 % ] and 23 serious [ 12 % ] ) and 156 ( 83 % ) on empagliflozin 25 mg ( 18 severe [ 10 % ] and 22 serious [ 12 % ] ) .
CONCLUSIONS	In patients with type 2 diabetes and stage 2 or 3 CKD , empagliflozin reduced HbA1c and was well tolerated .
CONCLUSIONS	However , our findings might not be applicable to the general population of patients with type 2 diabetes and renal impairment .
BACKGROUND	Boehringer Ingelheim , Eli Lilly .

###24252035
OBJECTIVE	We examined whether the addition of another conventional disease-modifying anti-rheumatic drugs ( DMARDs ) to methotrexate ( MTX ) upon infliximab ( IFX ) discontinuation in well-controlled rheumatoid arthritis ( RA ) patients could suppress subsequent disease flare .
METHODS	RA patients maintaining DAS28-CRP ( Disease Activity Score of 28 joints with C-reactive protein ) scores < 2.6 for 6 months with IFX were randomized either to receive addition of bucillamine ( BUC ) to MTX ( BUC + MTX group ; n = 24 ) or not ( MTX group ; n = 31 ) upon discontinuing IFX .
METHODS	The primary endpoint was the flare rate within 2 years of IFX discontinuation .
RESULTS	Six patients discontinuing MTX during the study were excluded from analyses .
RESULTS	Seventeen patients ( 63.0 % ) experienced flares in the MTX group , which was significantly reduced in the BUC + MTX group ( 31.8 % ; p = 0.045 ) .
RESULTS	Further , the flare rates differed significantly between remission and non-remission by a Boolean definition upon IFX discontinuation in the MTX group ( 40.0 % vs. 91.7 % , respectively ; p = 0.014 ) , but they were comparable in the BUC + MTX group .
RESULTS	BUC treatment was interrupted in seven patients due to rash , proteinuria and incompliance .
CONCLUSIONS	DMARDs combination therapy may be a better treatment strategy than MTX monotherapy for maintaining RA control after successful discontinuation of biological agents .

###24673474
OBJECTIVE	There are limited comparative studies on classic and new-generation antihistamines that affect sleep quality and mood .
OBJECTIVE	The purpose of this study was to determine and compare the effects of classic and new-generation antihistamines on sleep quality , daytime sleepiness , dream anxiety , and mood .
METHODS	Ninety-two patients with chronic pruritus completed study in the dermatology outpatient clinic .
METHODS	Treatments with regular recommended therapeutic doses were administered .
METHODS	The effects of antihistaminic drugs on mood , daytime sleepiness , dream anxiety , and sleep quality were assessed on the first day and 1 month after .
RESULTS	Outpatients who received cetirizine and hydroxyzine treatments reported higher scores on the depression , anxiety , and fatigue sub-scales than those who received desloratadine , levocetirizine , and rupatadine .
RESULTS	Pheniramine and rupatadine were found to be associated with daytime sleepiness and better sleep quality .
RESULTS	UKU side effects scale scores were significantly elevated among outpatients receiving pheniramine .
RESULTS	Classic antihistamines increased daytime sleepiness and decreased the sleep quality scores .
RESULTS	New-generation antihistamines reduced sleep latency and dream anxiety , and increased daytime sleepiness and sleep quality .
CONCLUSIONS	Both antihistamines , significantly increased daytime sleepiness and nocturnal sleep quality .
CONCLUSIONS	Daytime sleepiness was significantly predicted by rupadatine and pheniramine treatment .
CONCLUSIONS	Cetirizine and hydroxyzine , seem to have negative influences on mood states .
CONCLUSIONS	Given the extensive use of antihistamines in clinical settings , these results should be more elaborately examined in further studies .

###24856055
OBJECTIVE	Evaluate the effects of vaginal administration of isoflavones derived from Glycine max ( L. ) Merr .
OBJECTIVE	as a treatment option for vaginal atrophy , on the morphology and expression of estrogen receptors in vaginal epithelium of postmenopausal women .
METHODS	The double-blind , randomized , placebo-controlled , clinical trial .
METHODS	Sixty women were treated for 12 weeks with isoflavone vaginal gel 4 % ( 1g/day ) and a placebo gel .
METHODS	After 4 and 12 weeks , the vaginal atrophy symptoms were classified at none , mild , moderate and severe and the vaginal cytology were taken to determine the maturation value .
METHODS	Vaginal pH was measured at the beginning and end of therapy .
METHODS	Microbiopsies in vaginal fornix were performed before the treatment and after 12 weeks of treatment .
RESULTS	Isoflavone vaginal gel was effective for relief of vaginal dryness and dyspareunia symptons and an increase in the intermediate and superficial cells was noted .
RESULTS	The vaginal pH in the isoflavone group was 7.1 at baseline and 5.4 after 12 weeks , whereas in the placebo group there was no significant change .
RESULTS	A significant increase in thickness after treatment was detected in the Isoflavone Group .
RESULTS	The percentage of estrogen receptor positive cells in vaginal epithelium for the Isoflavone Group ranged from 58.5 % at the beginning of treatment to 82.6 % after 12 weeks .
RESULTS	These results were superior to placebo gel .
CONCLUSIONS	Glycine max ( L. ) Merr .
CONCLUSIONS	at 4 % vaginal gel on a daily basis in postmenopausal women led to improvements in vaginal atrophy symptoms , maturation values , vaginal pH , morphology and expression of estrogen receptors in vaginal epithelium .
CONCLUSIONS	Isoflavones proved good treatment options for relief of vulvovaginal atrophy .

###24621390
BACKGROUND	Breastfeeding has several advantages for both mother and child .
BACKGROUND	Lactation consultants may promote prolonged breastfeeding , but little is known about their impact on the initiation of complementary feeding .
METHODS	Dietary intake during the initial complementary feeding period from 5 to 6 months was collected on mother-infant pairs who had unlimited access to lactation consultants along with those mother-infant pairs who received routine care at the well-baby clinics .
METHODS	The total duration of breastfeeding in each study population was also recorded , and total breastfeeding durations of infants receiving complementary foods from 4 months and those exclusively breastfed for 6 months in each of the two study populations were compared .
RESULTS	Higher proportion of infants of mothers with unlimited access to lactation consultants were fed vegetable and vegetable pures ( p = 0.05 ) and more than one food type ( p = 0.05 ) at 5 months .
RESULTS	Furthermore , a lower percentage of them had three meals per day at 6 months ( p = 0.001 ) compared with those receiving routine care at the well-baby clinics .
RESULTS	Infants exclusively breastfed for 6 months all had similar duration of total breastfeeding .
CONCLUSIONS	Mother-infant pairs with unlimited access to lactation consultant had slower introduction of complementary foods at the initial complementary feeding period , according to number of infant 's meals at 6 months of age .
CONCLUSIONS	Furthermore , those exclusively breastfed for 6 months had more prolonged breastfeeding compared with mothers who began complementary feeding at 4 months regardless of exposure to lactation consultants .

###25497473
BACKGROUND	Most patients with major depressive disorder ( MDD ) report clinically significant sleep problems .
BACKGROUND	Pre-treatment insomnia has been associated with poorer treatment outcomes in some antidepressant trials , leading to suggestions that combined treatment regimens may be more successful in this subgroup .
BACKGROUND	This study investigated this question using data from the CO-MED trial .
METHODS	Adult outpatients with chronic and/or recurrent MDD were randomly assigned in 1:1:1 ratio to 28 weeks of single-blind , placebo-controlled antidepressant treatment with ( 1 ) escitalopram + placebo , ( 2 ) bupropion-sustained-release + escitalopram , or ( 3 ) venlafaxine-extended-release + mirtazapine .
METHODS	We compared baseline characteristics , tolerability , and treatment outcomes at 12 and 28 weeks for patients with and without pre-treatment insomnia .
RESULTS	Of the 665 evaluable patients , the majority ( 88.3 % ) reported significant pre-treatment insomnia .
RESULTS	Those with pre-treatment insomnia were more likely to be female ( 69.3 % vs. 57.7 % ) and African-American ( 29.1 % vs. 11.8 % ) .
RESULTS	Those with pre-treatment insomnia symptoms reported higher rates of concurrent anxiety disorders , lower rates of alcohol and substance use disorders , and greater impairment in psychosocial functioning .
RESULTS	The two groups did not differ in either tolerability or treatment outcomes among the three antidepressant treatments .
CONCLUSIONS	Insomnia symptoms , while common in patients with chronic/recurrent MDD were not predictive of response , remission , or tolerability with either single or combined antidepressant medications .

###25981758
BACKGROUND	Cystic fibrosis is a life-limiting disease that is caused by defective or deficient cystic fibrosis transmembrane conductance regulator ( CFTR ) protein activity .
BACKGROUND	Phe508del is the most common CFTR mutation .
METHODS	We conducted two phase 3 , randomized , double-blind , placebo-controlled studies that were designed to assess the effects of lumacaftor ( VX-809 ) , a CFTR corrector , in combination with ivacaftor ( VX-770 ) , a CFTR potentiator , in patients 12 years of age or older who had cystic fibrosis and were homozygous for the Phe508del CFTR mutation .
METHODS	In both studies , patients were randomly assigned to receive either lumacaftor ( 600 mg once daily or 400 mg every 12 hours ) in combination with ivacaftor ( 250 mg every 12 hours ) or matched placebo for 24 weeks .
METHODS	The primary end point was the absolute change from baseline in the percentage of predicted forced expiratory volume in 1 second ( FEV1 ) at week 24 .
RESULTS	A total of 1108 patients underwent randomization and received study drug .
RESULTS	The mean baseline FEV1 was 61 % of the predicted value .
RESULTS	In both studies , there were significant improvements in the primary end point in both lumacaftor-ivacaftor dose groups ; the difference between active treatment and placebo with respect to the mean absolute improvement in the percentage of predicted FEV1 ranged from 2.6 to 4.0 percentage points ( P < 0.001 ) , which corresponded to a mean relative treatment difference of 4.3 to 6.7 % ( P < 0.001 ) .
RESULTS	Pooled analyses showed that the rate of pulmonary exacerbations was 30 to 39 % lower in the lumacaftor-ivacaftor groups than in the placebo group ; the rate of events leading to hospitalization or the use of intravenous antibiotics was lower in the lumacaftor-ivacaftor groups as well .
RESULTS	The incidence of adverse events was generally similar in the lumacaftor-ivacaftor and placebo groups .
RESULTS	The rate of discontinuation due to an adverse event was 4.2 % among patients who received lumacaftor-ivacaftor versus 1.6 % among those who received placebo .
CONCLUSIONS	These data show that lumacaftor in combination with ivacaftor provided a benefit for patients with cystic fibrosis homozygous for the Phe508del CFTR mutation .
CONCLUSIONS	( Funded by Vertex Pharmaceuticals and others ; TRAFFIC and TRANSPORT ClinicalTrials.gov numbers , NCT01807923 and NCT01807949 . )

###25287366
OBJECTIVE	To compare the visual performances and patient satisfactions of conventional monovision , which corrects the dominant eye for distance vision , and crossed monovision , which corrects the non-dominant eye for distance vision in patients with pseudophakia .
METHODS	This prospective randomised study was conducted in 59 patients who underwent implantation of different targets of monofocal intraocular lens for each eye at Konkuk University Medical Center between November 2009 and August 2012 .
METHODS	The following were examined before bilateral cataract surgery and 2months after the surgery : refractive error , binocular uncorrected distance visual acuity ( UCDVA ) , uncorrected near visual acuity ( UCNVA ) , best corrected visual acuity ( BCVA ) and stereopsis .
METHODS	Questionnaires to evaluate postoperative spectacle dependence and patient satisfaction were completed by all patients .
RESULTS	The conventional monovision group and the crossed monovision group were composed of 28 and 31 patients , respectively .
RESULTS	There were no significant differences in postoperative UCDVA , UCNVA , BCVA and stereopsis between the two groups .
RESULTS	In addition , patient satisfaction with near and distant vision and spectacle dependence were not significantly different in the two groups .
CONCLUSIONS	The clinical results of the crossed monovision were not significantly different from the results of conventional monovision .
CONCLUSIONS	Therefore , crossed monovision can also be a valuable option for correcting postoperative presbyopia in patients considering bilateral cataract surgery .
BACKGROUND	KCT0001065 .

###24559809
BACKGROUND	The efficacy of pharmacotherapy for smoking cessation is well documented .
BACKGROUND	However , due to relapse rates and side effects , hypnotherapy is gaining attention as an alternative treatment option .
BACKGROUND	The aim of this one-center randomized study was to compare the efficacy of hypnotherapy alone , as well as hypnotherapy with nicotine replacement therapy ( NRT ) , to conventional NRT in patients hospitalized with a cardiac or pulmonary illness .
METHODS	We evaluated self-reported and biochemically verified 7-day prevalence smoking abstinence rates at 12 and 26 weeks post-hospitalization .
METHODS	Patients ( n = 164 ) were randomized into one of three counseling-based treatment groups : NRT for 30 days ( NRT ; n = 41 ) , a 90-min hypnotherapy session ( H ; n = 39 ) , and NRT with hypnotherapy ( HNRT ; n = 37 ) .
METHODS	Treatment groups were compared to a `` self-quit '' group of 35 patients who refused intervention .
RESULTS	Hypnotherapy patients were more likely than NRT patients to be nonsmokers at 12 weeks ( 43.9 % vs. 28.2 % ; p = 0.14 ) and 26 weeks after hospitalization ( 36.6 % vs. 18.0 % ; p = 0.06 ) .
RESULTS	Smoking abstinence rates in the HNRT group were similar to the H group .
RESULTS	There was no difference in smoking abstinence rates at 26 weeks between `` self quit '' and participants in any of the treatment groups .
RESULTS	In multivariable regression analysis adjusting for diagnosis and demographic characteristics , H and HNRT were over three times more likely than NRT participants to abstain at 26-weeks post-discharge ( RR = 3.6 ; p = 0.03 and RR = 3.2 ; p = 0.04 , respectively ) .
CONCLUSIONS	Hypnotherapy is more effective than NRT in improving smoking abstinence in patients hospitalized for a smoking-related illness , and could be an asset to post-discharge smoking cessation programs .

###25615430
OBJECTIVE	The current study investigated the effects of coaching as part of an emergent literacy professional development program to increase early childhood educators ' use of verbal references to print and phonological awareness during interactions with children .
METHODS	Thirty-one educators and 4 children from each of their classrooms ( N = 121 ) were randomly assigned to an experimental group ( 21 hr of in-service workshops plus 5 coaching sessions ) and a comparison group ( workshops alone ) .
METHODS	The in-service workshops included instruction on how to talk about print and phonological awareness during a post-story craft/writing activity .
METHODS	All educators were video-recorded during a 15-min craft/writing activity with a small group of preschoolers at pretest and posttest .
METHODS	All videotapes were transcribed and coded for verbal references to print and phonological awareness by the educators and children .
RESULTS	Although at posttest , there were no significant group differences in the educators ' or the children 's references to print as measured by rate per minute , both the educators and the children in the experimental group used a significantly higher rate per minute of references to phonological awareness relative to the comparison group .
CONCLUSIONS	Professional development that included coaching with a speech-language pathologist enabled educators and children to engage in more phonological awareness talk during this activity .

###24652107
BACKGROUND	Varenicline , a partial agonist at 42 nicotinic receptors ( nAChRs ) aids smoking cessation by reducing craving .
BACKGROUND	Successful quitting may be associated with greater inhibitory control but the effectiveness of varenicline in this regard is unknown .
OBJECTIVE	This study aimed to investigate the effect of varenicline on aspects of inhibitory control in smokers .
METHODS	A double-blind , placebo-controlled study investigating the effect of varenicline 1 mg ( or matched placebo ) in satiated and abstinent smokers .
METHODS	Tests included Rapid Visual Information Processing ( RVIP ) , Stop-Signal ( SS ) , Prospective Memory ( PM ) and the Cambridge Gambling Task ( CGT ) .
RESULTS	Smoking enhanced RVIP accuracy and latency to respond .
RESULTS	Varenicline did not alter RVIP performance , nor the effect of smoking , suggesting that these effects were unrelated to 42 nAChRs .
RESULTS	Smoking increased the number of errors during SS and increased the stop latency , indicating that smoking decreased inhibitory control .
RESULTS	Varenicline partially mimicked this effect of smoking but also reduced the smoking-induced increase , indicating a role for 42 nAChRs .
RESULTS	Likewise , smoking increased the number of points bet following a win during CGT and varenicline blocked this effect .
RESULTS	There was no effect of smoking or varenicline on PM target detection per se .
RESULTS	However , smoking protected the target detection rate in the ongoing task when a concurrent intention was introduced .
RESULTS	Varenicline improved response speed in both satiated and abstinent smokers .
CONCLUSIONS	Some aspects of inhibitory control may be mediated by 42-related mechanisms and blockade of smoking-induced disinhibition may contribute towards the action of varenicline as an aid to smoking cessation .

###26274517
OBJECTIVE	To evaluate vector analysis , rotational stability , and refractive and visual outcome of a new toric intraocular lens ( IOL ) for correction of preexisting corneal astigmatism during routine cataract surgery .
METHODS	In this prospective , interventional case series , 30 toric , aspheric Bi-Flex T toric IOLs ( Medicontur Medical Engineering Ltd. , Inc. , Zsmbk , Hungary ) were implanted in 20 consecutive patients with topographic corneal astigmatism between 1.50 and 4.00 diopters ( D ) and evaluated within the first year after implantation .
METHODS	Appropriate IOL-toric alignment was facilitated by combined imaging/eye tracking technology .
METHODS	Postoperative evaluation included refraction and uncorrected and corrected distance visual acuities ( UDVA , CDVA ) .
METHODS	For each visit , photodocumentation in retroillumination was performed to evaluate toric alignment and potential toric IOL rotation .
METHODS	Vector analysis of refractive astigmatism was performed using the Alpins method .
RESULTS	At 12 months postoperatively , a reduction of the refractive astigmatism from 1.930.90 D ( range : 0.50 to 4.00 D ) to 0.280.61 D ( range : 0.00 to 1.50 D ) could be found , with patients achieving a mean UDVA of 0.060.16 logMAR ( range : -0.18 to 0.40 logMAR ; Snellen 20/20 ) .
RESULTS	Intraoperative to 12-month postoperative comparison of IOL axis alignment showed low levels of rotation ( 0.22.41 ; range : +4 to -5 ) .
RESULTS	Vector analysis showed target induced astigmatism of 0.60 D @ 180 , surgically induced astigmatism of 0.80 D @ 177 , correction index of 1.020.25 , and a difference vector of 0.30 D @ 82 .
CONCLUSIONS	Implantation of the new Bi-Flex T IOL was a safe , stable , and effective method to correct preexisting regular corneal astigmatism during cataract surgery .

###25630944
OBJECTIVE	To examine the effectiveness of a physiotherapy-specific , web-based e-learning platform , `` RAP-el , '' in best-practice management of rheumatoid arthritis ( RA ) using a single-blind , randomized controlled trial ( RCT ) and prospective cohort study .
METHODS	Australian-registered physiotherapists were electronically randomized into intervention and control groups .
METHODS	The intervention group accessed RAP-eL over 4 weeks .
METHODS	Change in self-reported confidence in knowledge and skills was compared between groups at the end of the RCT using linear regression conditioned for baseline scores by a blinded assessor , using intent-to-treat analysis .
METHODS	Secondary outcomes included physiotherapists ' satisfaction with RA management and responses to RA-relevant clinical statements and practice-relevant vignettes .
METHODS	Retention was evaluated in a cohort study 8 weeks after the RCT .
RESULTS	Eighty physiotherapists were randomized into the intervention and 79 into the control groups .
RESULTS	Fifty-six and 48 , respectively , provided baseline data .
RESULTS	Significant between-group differences were observed for change in confidence in knowledge ( mean difference 8.51 ; 95 % confidence interval [ 95 % CI ] 6.29 , 10.73 ; effect size 1.62 ) and skills ( mean difference 7.26 ; 95 % CI 5.1 , 9.4 ; effect size 1.54 ) , with the intervention group performing better .
RESULTS	Satisfaction in ability to manage RA , 4 of the 6 clinical statements , and responses to vignettes demonstrated significant improvement in the intervention group .
RESULTS	Although 8-week scores showed declines in most outcomes , their clinical significance remains uncertain .
CONCLUSIONS	RAP-eL can improve self-reported confidence , likely practice behaviors and satisfaction in physiotherapists ' ability to manage people with RA , and improve their clinical knowledge in several areas of best-practice RA management in the short term .

###24479729
BACKGROUND	Most randomised clinical trials ( RCTs ) testing a new health service do not allow a run-in period of consolidation before evaluating the new approach .
BACKGROUND	Consequently , health professionals involved may feel insufficiently familiar or confident , or that new processes or systems that are integral to the service are insufficiently embedded in routine care prior to definitive evaluation in a RCT .
BACKGROUND	This study aimed to determine the optimal run-in period for a new physiotherapy-led telephone assessment and treatment service known as PhysioDirect and whether a run-in was needed prior to evaluating outcomes in an RCT .
METHODS	The PhysioDirect trial assessed whether PhysioDirect was as effective as usual care .
METHODS	Prior to the main trial , a run-in of up to 12 weeks was permitted to facilitate physiotherapists to become confident in delivering the new service .
METHODS	Outcomes collected from the run-in and main trial were length of telephone calls within the PhysioDirect service and patients ' physical function ( SF-36v2 questionnaire ) and Measure Yourself Medical Outcome Profile v2 collected at baseline and six months .
METHODS	Joinpoint regression determined how long it had taken call times to stabilise .
METHODS	Analysis of covariance determined whether patients ' physical function at six months changed from the run-in to the main trial .
RESULTS	Mean PhysioDirect call times ( minutes ) were higher in the run-in ( 31 ( SD : 12.6 ) ) than in the main trial ( 25 ( SD : 11.6 ) ) .
RESULTS	Each physiotherapist needed to answer 42 ( 95 % CI : 20,56 ) calls for their mean call time to stabilise at 25 minutes per call ; this took a minimum of seven weeks .
RESULTS	For patients ' physical function , PhysioDirect was equally clinically effective as usual care during both the run-in ( 0.17 ( 95 % CI : -0.91,1.24 ) ) and main trial ( -0.01 ( 95 % CI : -0.80,0.79 ) ) .
CONCLUSIONS	A run-in was not needed in a large trial testing PhysioDirect services in terms of patient outcomes .
CONCLUSIONS	A learning curve was evident in the process measure of telephone call length .
CONCLUSIONS	This decreased during the run-in and stabilised prior to commencement of the main trial .
CONCLUSIONS	Future trials should build in a run-in if it is anticipated that learning would have an effect on patient outcome .
BACKGROUND	Current Controlled Trials , ISRCTN55666618 .

###24942407
OBJECTIVE	Proton pump inhibitor ( PPI ) therapy has been shown to attenuate the antiplatelet effects of clopidogrel .
OBJECTIVE	The aim of this study was to compare the antiplatelet effects of cilostazol versus clopidogrel in patients co-administered a PPI .
METHODS	We enrolled PPI-nave stented patients treated with standard clopidogrel and aspirin therapy for at least six months ( n = 100 ) .
METHODS	The patients were randomly assigned to receive either cilostazol at a dose of 100mg twice daily ( CILO group ) or clopidogrel at a dose of 75mg daily ( CLPD group ) in addition to lansoprazole ( 30mg daily ) .
METHODS	The platelet aggregation ( PA ) determined using light transmittance aggregometry and the platelet reactivity index ( PRI ) obtained using a vasodilator-stimulated phosphoprotein phosphorylation assay were measured before randomization and at the 14-day follow-up visit .
METHODS	The primary endpoint was the PRI value at follow-up .
RESULTS	At follow-up , the CLPD group showed similar values of PRI as the CILO group ( 66.914.0 % vs. 63.114.1 % ; mean difference : 3.9 % ; 95 % confidence interval of difference : -1.7 % to 9.4 % ; p = 0.174 ) .
RESULTS	However , the 6g/mL collagen - and 0.5 mg/mL arachidonic acid-induced PA values in the CLPD group were higher than those observed in the CILO group ( mean differences : 9.8 % to 11.1 % ; all p values 0.001 ) .
RESULTS	CYP2C19 loss-of-function allele carriage was the major contributing factor associated with the PRI level in the absence of lansoprazole treatment ( with a gene-dose effect ) ; this association was not observed in the subjects receiving lansoprazole co-administration in the CLPD group .
CONCLUSIONS	During lansoprazole co-administration , cilostazol treatment achieves a more favorable platelet function profile than clopidogrel therapy .
CONCLUSIONS	The use of combination treatment with cilostazol and aspirin deserves further attention with respect to the management of stable stented patients requiring PPI co-administration .

###24328800
OBJECTIVE	This study examined the potential emotional sequelae following self-reported mild head injury ( MHI ; e.g. ` altered state of consciousness ' [ ASC ] ) in university students with a particular focus on arousal status and responsivity to experimental manipulation of arousal .
METHODS	A quasi-experimental design ( n = 91 ) was used to examine arousal status ( self-reported and physiological indices ) and response to manipulated arousal ( i.e. induced psychosocial stress/activation ; reduced activation/relaxation ) between persons who acknowledged prior MHI and persons with no-MHI .
RESULTS	University students who self-reported MHI were physiologically under-aroused and less responsive to stressors ( both laboratory and environmental ) compared to their no-MHI cohort .
RESULTS	Those with reported loss of consciousness demonstrated the most attenuated emotional arousal responses ( i.e. flattened electrodermal responsivity ) relative to those with only a reported ASC , followed by those with no-MHI .
CONCLUSIONS	The under-arousal in traumatic brain injury has been hypothesized to be associated with ventromedial prefrontal cortex disruption .
CONCLUSIONS	This under-arousal may be mirrored in persons who self-report experiencing subtle head trauma .
CONCLUSIONS	Students who reported MHI may be less able to physiologically respond and/or cognitively appraise stressful experiences as compared to their no-MHI cohort ; and experience subtle persistent consequences despite the subtle nature of the reported head trauma .

###25279395
OBJECTIVE	To investigate the efficacy of various formulations of chlorhexidine 0.2 % ( CHX ) in terms of plaque and gingival bleeding control compared to each other and to saline rinse ( CTRL ) over a 35-day rinsing period .
METHODS	Seventy subjects were randomly allocated to one of 4 groups rinsing twice daily for 35 days .
METHODS	The different groups used CHX 0.2 % rinse with alcohol ( CHX1 ) and without alcohol ( CHX2 ) , with an antidiscolouration system ( CHX3 ) or saline rinse ( CTRL ) .
METHODS	Clinical examinations to evaluate full-mouth plaque scores ( FMPS ) and periodontal parameters were performed at baseline , 7 , 21 and 35 days .
METHODS	Tooth discolouration ( TD ) was measured at each time point using digital photographs and spectrophotometric analysis .
RESULTS	At 35 days , CTRL showed the highest levels of plaque .
RESULTS	The mean changes in FMPS from baseline were 69.8 % 6.8 for CHX1 , 57.5 % 9.8 for CHX2 , 43.7 % 9.8 for CHX3 and 25.8 % 7.7 for CTRL .
RESULTS	Statistically significant differences were demonstrated between CHX1 and CHX3 ( p = 0.02 ) , CHX2 vs CHX3 ( p 0.05 ) and CHX1/CHX2 vs CHX3 ( p < 0.05 ) .
RESULTS	In contrast , CHX3 appeared more effective in reducing inflammatory indexes .
RESULTS	TD increased over time in 60 % to 70 % of participants , although lighter staining was found in the CHX3 group .
RESULTS	Greater FMPS reduction was observed in participants with staining vs without staining ( 26.0 % 12.3 , p = 0.04 ) .
CONCLUSIONS	Conventional CHX appeared more effective in terms of plaque reduction .
CONCLUSIONS	Interestingly , the newest formulation showed a higher control of gingival inflammation .
CONCLUSIONS	Staining was associated with lower plaque levels .

###24754314
BACKGROUND	Several long-acting injectable ( LAI ) second-generation antipsychotics are now available for the management of schizophrenia .
BACKGROUND	As patients with schizophrenia frequently present with diverse and challenging symptoms , it is important to understand the effects of antipsychotics in treating these different symptom subgroups and the timing of these responses .
METHODS	For this review , data from two randomized , double-blind trials were analyzed in respect to the onset and persistence of effects on several measures of psychopathology ( as measured by the Positive and Negative Syndrome Scale [ PANSS ] ) after treatment with LAI paliperidone palmitate ( PP ) ( NCT00590577 and NCT00589914 ) .
CONCLUSIONS	Symptom reductions from baseline with PP were significant by day 4 for all five PANSS factors in both studies .
CONCLUSIONS	Some effects may have been driven by the presence or absence of a placebo response .
CONCLUSIONS	A significant effect for PP versus placebo was observed for all major symptom domains for one or more doses of PP during the first month of treatment .
CONCLUSIONS	Once established , most ( but not all ) significant responses persisted to the end point .
CONCLUSIONS	Similar improvements were observed in PANSS scores with PP and oral risperidone .
CONCLUSIONS	Dose-dependent trends were observed for the effect of PP on positive , negative and uncontrolled hostility/excitement symptoms .

###24346151
OBJECTIVE	The aim of this study was to compare the effectiveness of low-level laser therapy and ultrasound therapy in the treatment of subacromial impingement syndrome .
METHODS	Thirty one patients with subacromial impingement syndrome were randomly assigned to low-level laser therapy group ( n = 16 ) and ultrasound therapy group ( n = 15 ) .
METHODS	Study participants received 10 treatment sessions of low-level laser therapy or ultrasound therapy over a period of two-consecutive weeks ( five days per week ) .
METHODS	Outcome measures ( visual analogue pain scale , Shoulder Pain and Disability Index - SPADI - , patient 's satisfactory level and sleep interference score ) were assessed before treatment and at the 1st and 3rd months after treatment .
METHODS	All patients were analyzed by the intent-to-treat principle .
RESULTS	Mean reduction in VAS pain , SPADI disability and sleep interference scores from baseline to after 1 month , and 3 months of treatment was statistically significant in both groups ( P < 0.05 ) .
RESULTS	However , there was no significant difference in the mean change in VAS pain , SPADI disability and sleep interference scores between the two groups ( P > 0.05 ) .
RESULTS	The mean level of patient satisfaction in group 1 at the first and third months after treatment was 72.45 23.45 mm and 71.50 16.54 mm , respectively .
RESULTS	The mean level of patient satisfaction in group 2 at the first and third months after treatment was 70.38 21.52 mm and 72.09 13.42 mm , respectively .
RESULTS	There was no significant difference in the mean level of patient satisfaction between the two groups ( p > 0.05 ) .
CONCLUSIONS	The results suggest that efficacy of both treatments were comparable to each other in regarding reducing pain severity and functional disability in patients with subacromial impingement syndrome .
CONCLUSIONS	Based on our findings , we conclude that low-level laser therapy may be considered as an effective alternative to ultrasound based therapy in patients with subacromial impingement syndrome especially ultrasound based therapy is contraindicated .

###25994910
BACKGROUND	Acute lymphoblastic leukemia ( ALL ) is the most frequent childhood malignancy .
BACKGROUND	Treatment has been unified in the middle of 1980 in the Czech Republic .
BACKGROUND	In 2002-2007 children and adolescents with acute lymphoblastic leukemia were treated in an international randomized trial ALL-IC BFM 2002 in the Czech Republic .
BACKGROUND	291 patients aged 1-18 years were enrolled ; infants below 1 year entered a separate trial .
RESULTS	Patients were stratified into three risk groups according to their age , initial leukocyte count , prednisone response , presence of fusion genes BCR/ABL or MLL/AF4 , bone marrow D +15 and remission status D +33 .
RESULTS	The whole therapy took 24 months .
RESULTS	Randomized late intensification compared standard BFM therapy with extended , usually more intensive experimental treatment .
RESULTS	The median follow-up was 8.7 years .
RESULTS	Complete remission was achieved in 97.9 % patients , 1 % died in remission .
RESULTS	11 % of children relapsed , 1.7 % with CNS involvement .
RESULTS	Six children ( 2.1 % ) developed secondary malignancy .
RESULTS	Event free survival ( EFS ) 8 years from diagnosis was 83.5 % , overall survival ( OS ) 91.4 % .
RESULTS	EFS and OS of the risk groups were : standard risk : 89.4 % ; 98.1 % ; intermediate risk : 82.6 % ; 89.6 % ; high risk : 68.8 % ; 78.1 % .
RESULTS	Male sex and age above 10 years were adverse prognostic factors .
CONCLUSIONS	In comparison with the previous trial ALL-BFM 95 , significant improvement was achieved .

###24411144
OBJECTIVE	This research was conducted to examine changes in self self-efficacy , ( the perception/belief that one can competently cope with a challenging situation ) in multiple sclerosis clients following a series of massage therapy treatments .
METHODS	This small practical trial investigated the effects of a pragmatic treatment protocol using a prospective randomized pretest posttest waitlist control design .
METHODS	Self-Efficacy scores were obtained before the first treatment , mid-treatment series , after the last treatment in the series , four weeks after the final treatment and again eight weeks after the final treatment had been received .
METHODS	The intervention involved a series of weekly one hour therapeutic massage treatments conducted over eight weeks and a subsequent eight week follow up period .
METHODS	All treatments were delivered by supervised student therapists in the final term of their two year massage therapy program .
METHODS	Self-Efficacy [ SE ] was the outcome for the study , measured using the Multiple Sclerosis Self-Efficacy survey [ MSSE ] .
METHODS	Descriptive statistics for SE scores were assessed and inferential analysis involved the testing of between group differences at each of the measurement points noted above .
RESULTS	Statistically significant improvement in self-efficacy was noted between treatment ( n = 8 ) and control ( n = 7 ) groups at mid treatment series ( t = 2.32 ; p < 0.02 ) , post treatment series ( t = 1.81 ; p < 0.05 ) and at four week follow up ( t = 2.24 ; p < 0.02 ) .
RESULTS	At the eight week follow up self-efficacy scores had decreased and there was no statistically significant difference between groups ( t = 0.87 ; p < 0.2 ) .
CONCLUSIONS	Study results support previous findings indicating that massage therapy increases the self-efficacy of clients with multiple sclerosis , potentially resulting in a better overall adjustment to the disease and an improvement in psycho-emotional state .
CONCLUSIONS	The increase in self-efficacy after 4 weeks of treatment suggests that positive response occurs more rapidly that was previously demonstrated .
CONCLUSIONS	The improvement in self-efficacy endured 4 weeks after the end of the treatment series , which suggests that massage therapy may have longer term effects on self-efficacy that were not previously noted .
CONCLUSIONS	Lack of inter group difference at the eight week follow up reinforces the notion that on-going treatment is required in order to maintain the positive changes observed .

###24239068
BACKGROUND	Drug abuse remains a serious problem in China , and has become a major threat to public health and social security .
BACKGROUND	Since the issuance and enforcement of the new Anti-Drug law in 2008 , the community has become the primary site for drug rehabilitation .
BACKGROUND	However , the attitudes of members in community toward the people with drug use disorders are unclear .
METHODS	A random sample of household respondents was studied in two communities in Hunan province in China .
METHODS	A total of 848 individuals participated ( response rate 83.7 % ) .
METHODS	Respondents initially were asked a set of questions about their knowledge about dug dependence , and then were randomly assigned to 1 of 4 vignette conditions .
METHODS	Three vignettes described different type of drug dependence meeting diagnostic criteria , and the fourth depicted a `` normal person . ''
RESULTS	Poor knowledge of drug dependence was common .
RESULTS	Negative attitudes towards drug dependent people were widespread .
RESULTS	Most respondents believed that drug dependence was caused by the person 's own weak will ( 82.0 % ) and own hedonistic lifestyle ( 81.3 % ) , and should be punished as illegal behavior ( 80.4 % ) .
RESULTS	The vast majority labeled the person with drug dependence as an addict , rated them as having undesirable characteristics , and expressed a strong desire for social distance .
RESULTS	There were few socio-demographic predictors of both poor knowledge and negative attitudes .
CONCLUSIONS	A community-based rehabilitation program in China should take into account the widespread stigmatization of people with drug dependence .

###24452393
OBJECTIVE	TAS-114 is a first-in-class oral deoxyuridine triphosphatase ( dUTPase ) inhibitor , which acts as a modulator of the pyrimidine nucleotide metabolic pathway .
OBJECTIVE	This was a first-in-human , phase 1 study that investigated the pharmacokinetics ( PK ) and safety of single-agent TAS-114 when it was given at single and multiple doses .
METHODS	For the single-dose cohort ( n = 25 ) , healthy male volunteers received a single dose of TAS-114 at 6 , 18 , 60 , 150 , and 300 mg .
METHODS	The magnitude of dihydropyrimidine dehydrogenase ( DPD ) inhibition and the food effect on TAS-114 PK were also investigated .
METHODS	For the multiple-dose cohort ( n = 10 ) , subjects received TAS-114 for 14 days consecutively .
RESULTS	In the dose-escalating single-dose cohort , the disposition of TAS-114 followed linear kinetics .
RESULTS	The elimination half-life was approximately 2 h.
RESULTS	The urine excretion rate and food effect were minimal .
RESULTS	A significant increase in uracil Cmax was observed at administered doses of 150 mg or higher of TAS-114 , suggesting that significant inhibition of DPD occurred at these doses .
RESULTS	No apparent CYP3A4 auto-induction was observed in the multiple-dose cohort .
RESULTS	No significant safety concerns at these dose levels were noted after single and multiple dosing .
CONCLUSIONS	TAS-114 has shown both a favorable safety and pharmacokinetic profile after single and repeated doses .
CONCLUSIONS	TAS-114 was considered to possess a moderate DPD inhibitory effect .
CONCLUSIONS	These findings will facilitate clinical studies of the combination chemotherapies in cancer patients and may reduce the safety risk in the frail cancer patients .

###25456803
OBJECTIVE	This study examines effects of a school garden intervention on elementary school children 's physical activity ( PA ) .
METHODS	Twelve schools in New York were randomly assigned to receive the school garden intervention ( n = 6 ) or to the waitlist control group that later received gardens ( n = 6 ) .
METHODS	PA was measured by self-report survey ( Girls Health Enrichment Multi-site Study Activity Questionnaire ) ( N = 227 ) and accelerometry ( N = 124 , 8 schools ) at baseline ( Fall 2011 ) and follow-up ( Spring 2012 , Fall 2012 , Spring 2013 ) .
METHODS	Direct observation ( N = 117 , 4 schools ) was employed to compare indoor ( classroom ) and outdoor ( garden ) PA. .
METHODS	Analysis was by general linear mixed models .
RESULTS	Survey data indicate garden intervention children 's reports of usual sedentary activity decreased from pre-garden baseline to post-garden more than the control group children 's ( = -.19 , p = .001 ) .
RESULTS	Accelerometry data reveal that during the school day , children in the garden intervention showed a greater increase in percent of time spent in moderate and moderate-to-vigorous PA from baseline to follow-up than the control group children ( = +.58 , p = .010 ; = +1.0 , p = .044 ) .
RESULTS	Direct observation within-group comparison of children at schools with gardens revealed that children move more and sit less during an outdoor garden-based lesson than during an indoor , classroom-based lesson .
CONCLUSIONS	School gardens show some promise to promote children 's PA. .
BACKGROUND	clinicaltrials.gov # NCT02148315 .

###24291272
OBJECTIVE	The goal of this study was to determine whether a less-invasive approach to aortic valve replacement ( AVR ) improves clinical outcomes in diabetic patients with aortic stenosis ( AS ) .
BACKGROUND	Diabetes is associated with increased morbidity and mortality after surgical AVR for AS .
METHODS	Among treated patients with severe symptomatic AS at high risk for surgery in the PARTNER ( Placement of Aortic Transcatheter Valve ) trial , we examined outcomes stratified according to diabetes status of patients randomly assigned to receive transcatheter or surgical AVR .
METHODS	The primary outcome was all-cause mortality at 1 year .
RESULTS	Among 657 patients enrolled in PARTNER who underwent treatment , there were 275 patients with diabetes ( 145transcatheter , 130 surgical ) .
RESULTS	There was a significant interaction between diabetes and treatment group for 1-year all-cause mortality ( p = 0.048 ) .
RESULTS	Among diabetic patients , all-cause mortality at 1 year was 18.0 % in the transcatheter group and 27.4 % in the surgical group ( hazard ratio : 0.60 [ 95 % confidence interval : 0.36 to 0.99 ] ; p = 0.04 ) .
RESULTS	Results were consistent among patients treated via transfemoral or transapical routes .
RESULTS	In contrast , among nondiabetic patients , there was no significant difference in all-cause mortality at 1 year ( p = 0.48 ) .
RESULTS	Among diabetic patients , the 1-year rates of stroke were similar between treatment groups ( 3.5 % transcatheter vs. 3.5 % surgery ; p = 0.88 ) , but the rate of renal failure requiring dialysis > 30 days was lower in the transcatheter group ( 0 % vs. 6.1 % ; p = 0.003 ) .
CONCLUSIONS	Among patients with diabetes and severe symptomatic AS at high risk for surgery , this post-hoc stratified analysis of the PARTNER trial suggests there is a survival benefit , no increase in stroke , and less renal failure from treatment with transcatheter AVR compared with surgical AVR .
CONCLUSIONS	( The PARTNER Trial : Placement of AoRTic TraNscathetER Valve Trial ; NCT00530894 ) .

###24489726
BACKGROUND	Whole body cryotherapy ( WBC ) is the therapeutic application of extreme cold air for a short duration .
BACKGROUND	Minimal evidence is available for determining optimal exposure time .
OBJECTIVE	To explore whether the length of WBC exposure induces differential changes in inflammatory markers , tissue oxygenation , skin and core temperature , thermal sensation and comfort .
METHODS	This study was a randomised cross over design with participants acting as their own control .
METHODS	Fourteen male professional first team super league rugby players were exposed to 1 , 2 , and 3 minutes of WBC at -135 C. Testing took place the day after a competitive league fixture , each exposure separated by seven days .
RESULTS	No significant changes were found in the inflammatory cytokine interleukin six .
RESULTS	Significant reductions ( p < 0.05 ) in deoxyhaemoglobin for gastrocnemius and vastus lateralis were found .
RESULTS	In vastus lateralis significant reductions ( p < 0.05 ) in oxyhaemoglobin and tissue oxygenation index ( p < 0.05 ) were demonstrated .
RESULTS	Significant reductions ( p < 0.05 ) in skin temperature were recorded .
RESULTS	No significant changes were recorded in core temperature .
RESULTS	Significant reductions ( p < 0.05 ) in thermal sensation and comfort were recorded .
CONCLUSIONS	Three brief exposures to WBC separated by 1 week are not sufficient to induce physiological changes in IL-6 or core temperature .
CONCLUSIONS	There are however significant changes in tissue oxyhaemoglobin , deoxyhaemoglobin , tissue oxygenation index , skin temperature and thermal sensation .
CONCLUSIONS	We conclude that a 2 minute WBC exposure was the optimum exposure length at temperatures of -135 C and could be applied as the basis for future studies .

###24909469
OBJECTIVE	The objective of the following study is to examine the effectiveness and safety of suspension laryngoscopy under intubation with propofol and remifentanil alone for vocal fold nodule ( VFN ) excision .
METHODS	A total of 40 patients were equally and randomly assigned to elective VFN excision using suspension laryngoscopy under intubation with propofol and remifentanil alone ( Group A ) or with supplementary cisatracurium ( Group B ) .
RESULTS	Intubation time was significantly longer in Group A than in Group B ( 300.0 30.0 s vs. 265.2 38.7 s , P = 0.003 ) .
RESULTS	The two groups showed similar Cormack-Lehane classifications , intubation conditions and ease of suspension laryngoscopy .
RESULTS	Both groups showed favorable cardiopulmonary safety profiles .
RESULTS	Post-anesthesia recovery was significantly more rapid in Group A than in Group B , in terms of times to spontaneous breathing return ( 7.2 1.4 min vs. 10.9 1.6 min , P < 0.001 ) , consciousness return ( 7.4 1.5 min vs. 12.3 1.8 min , P < 0.001 ) , removal of tracheal intubation ( 8.1 1.5 min vs. 13.2 1.7 min , P < 0.001 ) and operating room discharge ( 12.7 1.4 min vs. 22.1 1.3 min , P < 0.001 ) .
CONCLUSIONS	Use of propofol and remifentanil alone provides favorable intubation and anesthesia conditions for suspension laryngoscopic VFN excision and accelerates post-anesthesia recovery .

###24648401
BACKGROUND	Although some factors associated with rehospitalization after community-acquired pneumonia have been identified , other factors such as medical care utilization and medication usage have not been previously studied .
BACKGROUND	We investigated novel predictors of rehospitalization in patients admitted with pneumonia .
METHODS	Using Department of Veteran Affairs ( VA ) administrative data from October 2001 to September 2007 , we examined a cohort of patients 65 years old and older , who were hospitalized with pneumonia , in 150 VA acute care hospitals .
METHODS	The cohort was randomly split into derivation and validation samples , and then logistic regression models were used to identify and validate predictors of all-cause rehospitalization within 30 days .
RESULTS	Of the 45,134 subjects , 13 % were rehospitalized within 30 days .
RESULTS	No significant differences were noted between the derivation and validation cohorts .
RESULTS	Factors associated with readmission included age , marital status , chronic renal disease , prior malignancy , nursing home residence , congestive heart failure , use of oral corticosteroids , number of emergency department visits a year prior , prior admission , number of outpatient clinic visits in a year prior , and length of hospital stay .
RESULTS	The C statistics for the derivation and validation models were 0.615 and 0.613 , respectively .
CONCLUSIONS	Factors associated with readmission were largely unrelated to the underlying pneumonia , but were related to demographics , comorbidities , healthcare utilization , and length of stay on index admission .

###25306290
BACKGROUND	Exercise has been proposed as a possible treatment for postprandial hypotension ( PPH ) , yet , its use has not been extensively investigated .
BACKGROUND	This study aimed to determine the effects of intermittent walking on blood pressure ( BP ) and heart rate ( HR ) following ingestion of a glucose drink in older people with PPH .
METHODS	Thirteen persons with PPH were recruited and studied on 2 randomized days ( control , intervention ) .
METHODS	On both study days , participants ingested 200 mL of water containing 50 g glucose , followed by ambulatory BP and HR monitoring 6 minutely for 60 minutes , then 15 minutely until 120 minutes .
METHODS	On the intervention day , participants walked at their usual pace for 30 m every 30 minutes for 120 minutes .
RESULTS	On the control day , significant falls in systolic blood pressure ( SBP ) ( P < .005 ) and diastolic blood pressure ( DBP ) ( P = .016 ) were demonstrated between t = 0-120 minutes .
RESULTS	On the intervention day , over the same period , there was no significant fall in SBP ( P = .520 ) , however , DBP still fell significantly ( P = .045 ) .
RESULTS	There was a statistically significant difference ( P = .005 ) for the area under the curve for the change in SBP from baseline for the study days but not DBP ( P = .716 ) .
RESULTS	There was no significant change in HR ( control : P = .854 ; intervention , P = .168 ) nor between the area under the curve ( P = .798 ) for the change in HR from baseline for the study days .
CONCLUSIONS	This study suggests that in older people with PPH , intermittent walking at a usual pace attenuates the fall in SBP after ingestion of a glucose drink .

###25046622
OBJECTIVE	Cystoscopic intradetrusor injection of botulinum toxin has helped patients with refractory overactive bladder but with the increased risks of urinary tract infection and urinary retention .
OBJECTIVE	We assessed whether catheter instillation of 200 U onabotulinumtoxinA formulated with liposomes is safe and effective for the treatment of overactive bladder .
METHODS	This 2-center , double-blind , randomized , placebo controlled study enrolled patients with overactive bladder inadequately managed with antimuscarinics .
METHODS	Patients were assigned to intravesical instillation of lipo-botulinum toxin ( 31 ) or normal saline ( 31 ) .
METHODS	The primary end point was the mean change inmicturition events per 3 days at 4 weeks after treatment .
METHODS	Additional end points included mean changes in urgency events , frequency and urinary urge incontinence , as well as changes in overactive bladder symptom scores and urgency severity scores .
RESULTS	At 4 weeks after treatment lipo-botulinum toxin instillation was associated with a statistically significant decrease in micturition events per 3 days ( -4.64 for lipo-botulinum toxin vs -0.19 for placebo , p = 0.0252 ) .
RESULTS	Lipo-botulinum toxin instillation was also associated with a statistically significant decrease inurinary urgency events with respectto baseline but not placebo .
RESULTS	However , lipo-botulinum toxin instillation was associated with a statistically significant decrease in urgency severity scores compared to placebo ( p = 0.0181 ) .
RESULTS	These observed benefits of lipo-botulinum toxin instillation were not accompanied by an increased risk of urinary retention .
RESULTS	The effects of lipo-botulinum toxin onurinary urge incontinence were inconclusive .
CONCLUSIONS	A single intravesical instillation of lipo-botulinum toxin was associated with decreases in overactive bladder symptoms without side effects .
CONCLUSIONS	Intravesical instillation of liposomal botulinum toxin may be a promising approach to treat refractory overactive bladder .

###24228447
BACKGROUND	Postoperative analgesia is important in patients undergoing open abdominal surgery .
BACKGROUND	We prospectively compared the efficacy of ropivacaine and that of levobupivacaine for postoperative epidural analgesia in patients undergoing gynecological open abdominal surgery .
METHODS	Fifty-two ASA 1-2 patients scheduled for gynecological open abdominal surgery under combined general and epidural anesthesia were enrolled and randomized into two groups .
METHODS	In ropivacaine group ( n = 26 ) the patients received 0.187 % ropivacaine and fentanyl 3.2 microg x ml ( -1 ) for postoperative epidural analgesia .
METHODS	In levobupivacaine group ( n = 26 ) the patients received 0.187 % levobupivacaine and fentanyl 3.2 microg ml ( -1 ) .
METHODS	Visual analogue scale ( resting pain and pain on mobilization ) , the amount of rescue analgesics and epidural anesthesia related adverse events such as hypotension , nausea and vomiting were observed for 48 hours after surgery .
RESULTS	There were no differences in visual analogue scale at all intervals between the two groups .
RESULTS	In levobupivacaine group the patients used less amounts of rescue analgesics than ropivacaine group ( P = 0.01 ) .
RESULTS	There were no differences in the incidences of postoperative hypotension , nausea and vomiting between the two groups .
CONCLUSIONS	Both 0.187 % ropivacaine and levobupivacaine similarly provide appropriate postoperative epidural analgesia for patients undergoing gynecological open abdominal surgery .

###24784827
OBJECTIVE	To determine the benefit of multifactorial treatment on microvascular complications among people with type 2 diabetes detected by screening .
METHODS	This study was a multicenter cluster randomized controlled trial in primary care with randomization at the practice level .
METHODS	In four centers in Denmark ; Cambridge , U.K. ; the Netherlands ; and Leicester , U.K. , 343 general practices participated in the trial .
METHODS	Eligible for follow-up were 2,861 of the 3,057 people with diabetes detected by screening included in the original trial .
METHODS	Biomedical data on nephropathy were collected in 2,710 ( 94.7 % ) participants , retinal photos in 2,190 ( 76.6 % ) , and questionnaire data on peripheral neuropathy in 2,312 ( 80.9 % ) .
METHODS	The prespecified microvascular end points were analyzed by intention to treat .
METHODS	Results from the four centers were pooled using fixed-effects meta-analysis .
RESULTS	Five years after diagnosis , any kind of albuminuria was present in 22.7 % of participants in the intensive treatment ( IT ) group and in 24.4 % in the routine care ( RC ) group ( odds ratio 0.87 [ 95 % CI 0.72-1 .07 ] ) .
RESULTS	Retinopathy was present in 10.2 % of the IT group and 12.1 % of the RC group ( 0.84 [ 0.64-1 .10 ] ) , and severe retinopathy was present in one patient in the IT group and seven in the RC group .
RESULTS	Neuropathy was present in 4.9 % and 5.9 % ( 0.95 [ 0.68-1 .34 ] ) , respectively .
RESULTS	Estimated glomerular filtration rate increased between baseline and follow-up in both groups ( 4.31 and 6.44 mL/min , respectively ) .
CONCLUSIONS	Compared with RC , an intervention to promote target-driven , intensive management of patients with type 2 diabetes detected by screening was not associated with significant reductions in the frequency of microvascular events at 5 years .

###24990160
OBJECTIVE	To determine the feasibility , acceptability and safety of using acupuncture to treat arm lymphoedema in women following treatment for breast cancer .
METHODS	We conducted a randomised controlled trial of acupuncture compared with treatment as usual .
METHODS	Twenty women with stable unilateral intransient lymphoedema present for at least 6months were recruited from Sydney , Australia .
METHODS	The women received 12 acupuncture treatments administered to body and arm points on the non-lymphoedematous limb over 8weeks , twice weekly for 4weeks then once weekly for 4weeks .
METHODS	Outcome measures included an assessment of interest to participate in the trial , identification of successful recruitment strategies , the appropriateness of eligibility criteria and compliance with treatment attendance .
METHODS	Clinical outcomes were assessed at baseline and 8weeks and included extracellular fluid , lymphoedema symptoms , well-being and safety .
RESULTS	Acupuncture was an acceptable intervention in women with upper limb lymphoedema .
RESULTS	Compliance with the treatment protocol was high , with nine women completing all 12 treatments .
RESULTS	Outcome forms were completed by 17 women at 8weeks .
RESULTS	No major adverse occurrences , as defined by the study protocol , were reported from the acupuncture group although one woman found the needling uncomfortable , and no study participant experienced an increase in swelling of > 10 % .
RESULTS	There was no change in extracellular fluid or any patient-reported outcome measurement .
CONCLUSIONS	Lymphoedema is a persistent symptom experienced by women recovering from breast cancer .
CONCLUSIONS	Our study suggests that acupuncture may stabilise symptoms and no major safety concerns were identified , so further research is needed .
BACKGROUND	Australian New Zealand Clinical Trials Registry , http://www.anzctr.org.au ACTRN12612000607875 .

###24384609
BACKGROUND	Inhaled corticosteroids , known to be effective as a maintenance medication in chronic asthma , have also been suggested as a therapy for acute asthma when given at high doses .
METHODS	A double-blind , randomized , placebo-controlled trial was conducted in children aged 2 to 12 years with moderate or severe acute asthma , as determined based on a clinical score of 5 to 15 points , where 15 is the most severe .
METHODS	We compared the addition of budesonide 1,500 g vs placebo to standard acute asthma treatment , which included salbutamol , ipratropium bromide , and a single dose of prednisolone 2 mg/kg given at the beginning of therapy .
METHODS	The primary outcome was hospital admission rate within 4 h.
RESULTS	A total of 906 ED visits by children with moderate or severe acute asthma were evaluated .
RESULTS	Seventy-five cases out of 458 ( 16.4 % ) in the budesonide group vs 82 of 448 ( 18.3 % ) in the placebo group were admitted ( OR , 0.84 ; 95 % CI , 0.58-1 .23 ; P = .38 ) .
RESULTS	However , among cases with high baseline clinical score ( 13 ) , significantly fewer children were admitted in the budesonide group ( 27 of 76 [ 35.5 % ] ) than in the placebo group ( 39 of 73 [ 53.4 % ] ; OR , 0.42 ; 95 % CI , 0.19-0 .94 ; P = .03 ) .
CONCLUSIONS	The addition of budesonide nebulization did not decrease the admission rate of children with acute asthma overall .
CONCLUSIONS	However , it may decrease the admission rate of children with severe acute asthma .
BACKGROUND	ClinicalTrials.gov ; No. : NCT01524198 ; URL : www.clinicaltrials.gov

###25932697
BACKGROUND	Although hepatitis A virus ( HAV ) and hepatitis B virus ( HBV ) infections are vaccine-preventable diseases , few homeless parolees coming out of prisons and jails have received the hepatitis A and B vaccination series .
OBJECTIVE	The study focused on completion of the HAV and HBV vaccine series among homeless men on parole .
OBJECTIVE	The efficacy of three levels of peer coaching ( PC ) and nurse-delivered interventions was compared at 12-month follow-up : ( a ) intensive peer coaching and nurse case management ( PC-NCM ) ; ( b ) intensive PC intervention condition , with minimal nurse involvement ; and ( c ) usual care ( UC ) intervention condition , which included minimal PC and nurse involvement .
OBJECTIVE	Furthermore , we assessed predictors of vaccine completion among this targeted sample .
METHODS	A randomized control trial was conducted with 600 recently paroled men to assess the impact of the three intervention conditions ( PC-NCM vs. PC vs. UC ) on reducing drug use and recidivism ; of these , 345 seronegative , vaccine-eligible subjects were included in this analysis of completion of the Twinrix HAV/HBV vaccine .
METHODS	Logistic regression was added to assess predictors of completion of the HAV/HBV vaccine series and chi-square analysis to compare completion rates across the three levels of intervention .
RESULTS	Vaccine completion rate for the intervention conditions were 75.4 % ( PC-NCM ) , 71.8 % ( PC ) , and 71.9 % ( UC ; p = .78 ) .
RESULTS	Predictors of vaccine noncompletion included being Asian and Pacific Islander , experiencing high levels of hostility , positive social support , reporting a history of injection drug use , being released early from California prisons , and being admitted for psychiatric illness .
RESULTS	Predictors of vaccine series completion included reporting having six or more friends , recent cocaine use , and staying in drug treatment for at least 90 days .
CONCLUSIONS	Findings allow greater understanding of factors affecting vaccination completion in order to design more effective programs among the high-risk population of men recently released from prison and on parole .

###24590363
OBJECTIVE	Our study indicates a prototype blood-based variant Creutzfeldt-Jakob disease ( vCJD ) assay has sufficient sensitivity and specificity to justify a large study comparing vCJD prevalence in the United Kingdom with a bovine spongiform encephalopathy-unexposed population .
OBJECTIVE	In a clinical diagnostic capacity , the assay 's likelihood ratios dramatically change an individual 's pretest disease odds to posttest probabilities and can confirm vCJD infection .
OBJECTIVE	To determine the diagnostic accuracy of a prototype blood test for vCJD and hence its suitability for clinical use and for screening prion-exposed populations .
METHODS	Retrospective , cross-sectional diagnostic study of blood samples from national blood collection and prion disease centers in the United States and United Kingdom .
METHODS	Anonymized samples were representative of the US blood donor population ( n = 5000 ) , healthy UK donors ( n = 200 ) , patients with nonprion neurodegenerative diseases ( n = 352 ) , patients in whom a prion disease diagnosis was likely ( n = 105 ) , and patients with confirmed vCJD ( n = 10 ) .
METHODS	Presence of vCJD infection determined by a prototype test ( now in clinical diagnostic use ) that captures , enriches , and detects disease-associated prion protein from whole blood using stainless steel powder .
RESULTS	The assay 's specificity among the presumed negative American donor samples was 100 % ( 95 % CI , 99.93 % -100 % ) and was confirmed in a healthy UK cohort ( 100 % specificity ; 95 % CI , 98.2 % -100 % ) .
RESULTS	Of potentially cross-reactive blood samples from patients with nonprion neurodegenerative diseases , no samples tested positive ( 100 % specificity ; 95 % CI , 98.9 % -100 % ) .
RESULTS	Among National Prion Clinic referrals in whom a prion disease diagnosis was likely , 2 patients with sporadic CJD tested positive ( 98.1 % specificity ; 95 % CI , 93.3 % -99.8 % ) .
RESULTS	Finally , we reconfirmed but could not refine our previous sensitivity estimate in a small blind panel of samples from unaffected individuals and patients with vCJD ( 70 % sensitivity ; 95 % CI , 34.8 % -93.3 % ) .
CONCLUSIONS	In conjunction with the assay 's established high sensitivity ( 71.4 % ; 95 % CI , 47.8 % -88.7 % ) , the extremely high specificity supports using the assay to screen for vCJD infection in prion-exposed populations .
CONCLUSIONS	Additionally , the lack of cross-reactivity and false positives in a range of nonprion neurodegenerative diseases supports the use of the assay in patient diagnosis .

###25437533
OBJECTIVE	Tadalafil once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia consistently shows statistically significant I-PSS improvements .
OBJECTIVE	However , physicians and patients wish to know whether tadalafil provides rapid , clinically meaningful improvement in lower urinary tract symptoms .
OBJECTIVE	In this post hoc analysis we integrated results from 4 placebo controlled studies to determine the duration of tadalafil once daily required to achieve clinically meaningful improvement .
METHODS	We performed post hoc analysis of data integrated from 4 double-blind studies of tadalafil 5 mg and placebo once daily in 742 and 735 men , respectively , 45 years old or older with total I-PSS 13 or greater .
METHODS	Two clinically meaningful improvement categories were assessed , including 1 ) 3-point or greater baseline to end point total I-PSS improvement and 2 ) 25 % or greater baseline to end point total I-PSS improvement .
METHODS	I-PSS was assessed at weeks 4 , 8 and 12 in all studies , week 1 in 2 and week 2 in 1 .
METHODS	Results in men treated with tadalafil who showed clinically meaningful improvement ( responders ) were further examined to determine the earliest time to clinically meaningful improvement .
RESULTS	Of 742 tadalafil treated patients 513 ( 69.1 % ) and 444 ( 59.8 % ) demonstrated category 1 and 2 clinically meaningful improvement , respectively , at the study end point .
RESULTS	Of 234 category 1 responders with week 1 assessments 140 ( 59.8 % ) achieved clinically meaningful improvement by week 1 and 407 of the total of 513 category 1 responders ( 79.3 % ) showed it by week 4 .
RESULTS	Of the 205 category 2 responders with week 1 assessments 103 ( 50.2 % ) achieved clinically meaningful improvement by week 1 while 322 of the 444 category 2 responders ( 72.5 % ) did so by week 4 .
CONCLUSIONS	Tadalafil 5 mg once daily led to clinically meaningful improvement in approximately two-thirds of men with lower urinary tract symptoms secondary to benign prostatic hyperplasia .
CONCLUSIONS	More than half of this group of tadalafil treated responders achieved clinically meaningful improvement after 1 week of therapy and more than 70 % did so within 4 weeks .

###24502769
BACKGROUND	Spatial neglect is a frequent and debilitating consequence of acquired brain injury and currently has no widely accepted standard of care .
BACKGROUND	While previous interventions for spatial neglect have targeted patients ' overt spatial deficits ( e.g. , reduced contralesional visual scanning ) , far fewer have directly targeted patients ' non-spatial deficits ( e.g. , sustained attention deficits ) .
BACKGROUND	Considering that non-spatial deficits have shown to be highly predictive of long-term disability , we developed a novel computer based training program that targets both sustained ( tonic ) and moment-to-moment ( phasic ) aspects of non-spatial attention ( Tonic and Phasic Alertness Training , TAPAT ) .
BACKGROUND	Preliminary studies demonstrate that TAPAT is safe and effective in improving both spatial and non-spatial attention deficits in the post-acute recovery phase in neglect patients .
BACKGROUND	The purpose of the current trial ( referred to as the REmediation of SPatial Neglect or RESPONSE trial ) is to compare TAPAT to an active control training condition , include a larger sample of patients , and assess both cognitive and functional outcomes .
METHODS	We will employ a multi-site , longitudinal , blinded randomized controlled trial ( RCT ) design with a target sample of 114 patients with spatial neglect .
METHODS	Patients will either perform , at their home , the experimental TAPAT training program or an active control computer games condition for thirty minutes/day , five days a week , over three months .
METHODS	Patients will be assessed on a battery of cognitive and functional outcomes on three occasions : a ) immediately before training , b ) within forty-eight hours post completion of total training , and c ) after a three-month no-contact period post completion of total training , to assess the longevity of potential training effects .
CONCLUSIONS	The strengths of this protocol are that it tests an innovative , in-home administered treatment that targets a fundamental deficit in neglect , employs highly sensitive computer-based assessments of cognition as well as functional outcomes , and incorporates a large sample size ( relative to other neglect treatment studies ) in an RCT design .
BACKGROUND	ClinicalTrials.gov identifier , NCT01965951 .

###25854019
OBJECTIVE	To observe the clinical efficacy of acupuncture combined with auricular point sticking for menstrual headache and to discuss its mechanism .
METHODS	Eighty-five patients with menstrual headache were randomly divided into an observation group ( 43 cases ) and a control group ( 42 cases ) .
METHODS	The observation group was treated with body acupuncture combined with auricular point sticking and the control group was treated with flunarizine hydrochloride capsules orally .
METHODS	The treatments of 3 menstrual cycles were required .
METHODS	The clinical efficacy was observed in the two groups .
METHODS	The content of serum prostaglandin F2 , ( PGF2 ) and plasma arginine vasopressin ( AVP ) in the menstrual periods of some patients randomly selected in the two groups was tested before and after treatment and was compared with that of 20 cases in a normal group .
METHODS	Results The total effective rate was 95.4 % ( 41/43 ) in the observation group which was obviously superior to 81.0 % ( 34/42 ) in the control group ( P < 0.01 ) .
METHODS	Before treatment , the content of serum PGF2 and plasma AVP of patients in the two groups was higher than that in the normal group ( all P < 0.01 ) .
METHODS	After treatment , the content of serum PGF2 and plasma AVP was lower than that before treatment in the two groups ( P < 0.01 , P < 0.05 ) .
METHODS	The content of serum PGF2 in the observation group was decreased significantly compared with that in the control group ( P < 0.05 ) and returned to the level of the normal group .
CONCLUSIONS	Body acupuncture combined with auricular point sticking achieves positive efficacy for menstrual headache and its mechanism could be related to regulating the abnormal levels of serum PGF2 and plasma AVP .

###25196631
OBJECTIVE	It was the aim of this study to compare the efficacy of ozone therapy and drug treatment in patients with painful temporomandibular joint ( TMJ ) disorder ( TMD ) .
METHODS	A total of 63 patients with TMD were enrolled ; 33 were treated with bio-oxidative therapy and 30 with a ketoprofen tablet thiocolchicoside capsule 2 1 for 7 days .
METHODS	Maximum voluntary interincisal mouth opening ( MMO ) was measured in millimeters using a scale and recorded during the pre - and posttreatment periods .
METHODS	The patients evaluated their subjective pain using a visual analogue scale ( VAS ) .
METHODS	Data were analyzed using the Mann-Whitney U test , the Kolmogorov-Smirnov test , and the independent t test .
RESULTS	The mean MMO of the group that received ozone therapy during the pretreatment period was 46.51 8.2 mm , and it immediately increased to 48.78 7.5 mm after 1 week of ozone therapy , which was statistically significant ( p = 0.04 ) .
RESULTS	For those who received medication , the mean MMO during the pretreatment period was 46.30 mm , and at the end of 1 week it was 46.9 mm .
RESULTS	In the ozone group , 29 % of patients showed a gradual decrease in their VAS pain scores compared to pretreatment values ( 6.3 2.1 to 3.0 2.2 ) .
RESULTS	In the medication group , 24 % of patients showed a significant decrease in VAS pain scores during the follow-up period ( 6.9 1.4 to 5.0 1.5 ) .
CONCLUSIONS	This study showed that bio-oxidative therapy was a more effective treatment than medication therapy for relieving TMJ pain .

###24634631
OBJECTIVE	Previous studies have demonstrated pronounced reduction of REM sleep on the first nights following major surgery which may influence pain , analgesic use , and recovery .
OBJECTIVE	This placebo-controlled , randomized , double-blind study set out to evaluate the effect of zolpidem on sleep architecture in an elderly population undergoing fast-track total hip and knee arthroplasty ( THA/TKA ) with length of stay < 3 days .
METHODS	Twenty patients ( 60 years ) undergoing THA or TKA in a standardized setup with spinal anesthesia and multimodal opioid-sparing postoperative analgesia were included .
METHODS	Polysomnography measures were performed for 2 nights , 1 night at home prior to surgery and on the first night after surgery , when the patient received placebo or zolpidem 10 mg .
METHODS	Analgesic use , pain levels , and subjective measures of fatigue and sleep quality were recorded .
METHODS	Analysis of sleep data was performed according to the American Academy of Sleep Medicine manual .
RESULTS	Objective sleep data did not show a significant difference between groups in any of the sleep stages .
RESULTS	However , subjective data on sleep quality and fatigue showed significantly less fatigue and better sleep quality in the zolpidem group ( p < 0.05 ) , and reduced objectively recorded number of arousals ( p = 0.004 ) .
RESULTS	Levels of pain and opioid use were similar in the 2 groups .
CONCLUSIONS	Our objective data did not support the primary hypothesis that one night 's treatment with zolpidem would significantly improve sleep architecture following major surgery , although there was improved feeling of sleep quality and fatigue associated with fewer postoperative arousals .
BACKGROUND	Krenk L ; Jennum P ; Kehlet H. Postoperative sleep disturbances after zolpidem treatment in fast-track hip and knee replacement .

###25626401
OBJECTIVE	This study aimed to assess the effects of sampling interval ( SI ) of computed tomographic ( CT ) perfusion acquisitions on CT perfusion values in normal liver and liver metastases from neuroendocrine tumors .
METHODS	Computed tomographic perfusion in 16 patients with neuroendocrine liver metastases was analyzed using distributed-parameter modeling to yield tissue blood flow , blood volume , mean transit time , permeability , and hepatic arterial fraction for tumor and normal liver .
METHODS	Computed tomographic perfusion values for the reference SI of 0.5 s ( SI0 .5 ) were compared with those of SI data sets of 1 second , 2 seconds , 3 seconds , and 4 seconds using mixed-effects model analyses .
RESULTS	Increases in SI beyond 1 second were associated with significant and increasing departures of CT perfusion parameters from the reference values at SI0 .5 ( P 0.0009 ) .
RESULTS	Computed tomographic perfusion values deviated from the reference with increasing uncertainty with increasing SIs .
RESULTS	Findings for normal liver were concordant .
CONCLUSIONS	Increasing SIs beyond 1 second yield significantly different CT perfusion parameter values compared with the reference values at SI0 .5 .

###25109412
OBJECTIVE	Guanfacine extended - release ( GXR ) is approved for the treatment of attention-deficit/hyperactivity disorder in children and adolescents .
OBJECTIVE	As part of the clinical development of GXR , and to further explore the effect of guanfacine on QT intervals , a thorough QT study of guanfacine was conducted ( ClinicalTrials .
OBJECTIVE	gov identifier : NCT00672984 ) .
METHODS	In this double-blind , 3-period , crossover trial , healthy adults ( n = 83 ) received immediaterelease guanfacine ( at therapeutic ( 4 mg ) and supra-therapeutic ( 8 mg ) doses ) , placebo , and 400 mg moxifloxacin ( positive control ) in 1 of 6 randomly assigned sequences .
METHODS	Continuous 12-lead electrocardiograms were extracted , and guanfacine plasma concentrations were assessed pre-dose and at intervals up to 24 hours post-dose .
METHODS	QT intervals were corrected using 2 methods : subject-specific ( QTcNi ) and Fridericia ( QTcF ) .
METHODS	Time-matched analyses examined the largest , baseline-adjusted , drug-placebo difference in QTc intervals .
RESULTS	In the QTcNi analysis , the largest 1-sided 95 % upper confidence bound ( UCB ) through hour 12 was 1.94 ms ( 12 hours postdose ) .
RESULTS	For the 12-hour QTcF analysis , the largest 1-sided 95 % UCB was 10.34 ms ( 12 hours post-supratherapeutic dose ) , representing the only 1-sided 95 % UCB > 10 ms. Following the supra-therapeutic dose , maximum guanfacine plasma concentration was attained at 5.0 hours ( median ) post-dose .
RESULTS	Assay sensitivity was confirmed by moxifloxacin results .
RESULTS	Among guanfacine-treated subjects , most treatment-emergent adverse events were mild ( 78.9 % ) ; dry mouth ( 65.8 % ) and dizziness ( 61.8 % ) were most common .
CONCLUSIONS	Neither therapeutic nor supra-therapeutic doses of guanfacine prolonged QT interval after adjusting for heart rate using individualized correction , QTcNi , through 12 hours postdose .
CONCLUSIONS	Guanfacine does not appear to interfere with cardiac repolarization of the form associated with pro-arrhythmic drugs .

###24275841
BACKGROUND	Previous studies reported increased white blood cell counts ( WBCCs ) , an inflammatory marker , in hypertension , prehypertension and metabolic syndrome .
BACKGROUND	Evidence suggests that inflammation precedes blood pressure ( BP ) elevation and may contribute to incident hypertension .
BACKGROUND	Angiotensin receptor blockers ( ARBs ) may reduce inflammation .
BACKGROUND	We analyzed WBCC trends in TRial Of Preventing HYpertension ( TROPHY ) to determine if this inflammatory marker predicted incident hypertension in prehypertensive individuals and whether randomized assignment to the ARB candesartan ( 391 individuals ) for 2 years , lowered WBCC compared with placebo-treated controls ( 381 individuals ) .
METHODS	A new analysis of TROPHY trial data .
RESULTS	In the total population , baseline BMI correlated with WBCC ( r = 0.185 , P < 0.0001 ) , neutrophils ( r = 0.135 , P < 0.001 ) and lymphocytes ( r = 0.204 , P < 0.0001 ) .
RESULTS	Baseline triglycerides also correlated significantly with inflammatory markers .
RESULTS	Despite a wide range of home BP ( HBP ) values , HBP did not correlate with baseline WBCC counts .
RESULTS	After 2 years , candesartan decreased placebo corrected HBP by -5.5 / -2.5 mmHg , ( P < 0.0001 ) , but WBCC , neutrophil and lymphocyte counts were not different in placebo and in candesartan groups .
RESULTS	Baseline WBCC , neutrophils and lymphocyte counts did not predict incident hypertension in the placebo group .
CONCLUSIONS	In TROPHY , candesartan lowered BP but did not alter WBCC .
CONCLUSIONS	Baseline WBCC did not predict incident hypertension .
CONCLUSIONS	Our findings do not support the hypothesis that inflammation contributes to incident hypertension or that ARB treatment suppresses inflammation .
CONCLUSIONS	The significant independent association of WBCC with baseline BMI and triglycerides is consistent with the evidence that obesity and insulin resistance are associated with inflammation .
CONCLUSIONS	The findings highlight the importance of effective lifestyle modification in prehypertension to reduce inflammatory cardio-metabolic risk and suppress transition to hypertension .

###25188489
BACKGROUND	Sociodemographic differences have been observed in the treatment of extremely premature ( periviable ) neonates , but the source of this variation is not well understood .
BACKGROUND	We assessed the feasibility of using simulation to test the effect of maternal race and insurance status on shared decision making ( SDM ) in periviable counseling .
METHODS	We conducted a 2 2 factorial simulation experiment in which obstetricians and neonatologists counseled 2 consecutive standardized patients diagnosed with ruptured membranes at 23 weeks , counterbalancing race ( black/white ) and insurance status using random permutation .
METHODS	We assessed verisimilitude of the simulation in semistructured debriefing interviews .
METHODS	We coded physician communication related to resuscitation , mode of delivery , and steroid decisions using a 9-point SDM coding framework and then compared communication scores by standardized patient race and insurer using analysis of variance .
RESULTS	Sixteen obstetricians and 15 neonatologists participated ; 71 % were women , 84 % were married , and 75 % were parents ; 91 % of the physicians rated the simulation as highly realistic .
RESULTS	Overall , SDM scores were relatively high , with means ranging from 6.4 to 7.9 ( of 9 ) .
RESULTS	There was a statistically significant interaction between race and insurer for SDM related to steroid use and mode of delivery ( P < 0.01 and P = 0.01 , respectively ) .
RESULTS	Between-group comparison revealed nonsignificant differences ( P = < 0.10 ) between the SDM scores for privately insured black patients versus privately insured white patients , Medicaid-insured white patients versus Medicaid-insured black patients , and privately insured black patients versus Medicaid-insured black patients .
CONCLUSIONS	This study confirms that simulation is a feasible method for studying sociodemographic effects on periviable counseling .
CONCLUSIONS	Shared decision making may occur differentially based on patients ' sociodemographic characteristics and deserves further study .

###25033994
BACKGROUND	Increased left ventricular ( LV ) size is associated with cardiovascular mortality and morbidity .
BACKGROUND	Once non-contrast cardiac computed tomography ( CT ) is performed for other purposes , information of LV size is readily available .
OBJECTIVE	To determine the association of gated CT-derived LV size with cardiovascular risk factors and coronary artery calcification ( CAC ) and to describe age - and gender-specific normative values in a general population cohort .
METHODS	LV area was quantified from non-contrast-enhanced CT in axial , end-diastolic images at a mid-ventricular slice in participants of the population-based Heinz Nixdorf Recall Study , free of known cardiovascular disease .
METHODS	LV index ( LVI ) was calculated by the quotient of LV area and body surface area ( BSA ) .
METHODS	Crude and adjusted regression analyses were used to determine the association of LVI with risk factors and CAC .
RESULTS	Overall , 3926 subjects ( age 59 8 years , 53 % women ) were included in this analysis .
RESULTS	From quantification in end-diastolic phase , men had larger LV index ( 2232 296 mm ( 2 ) / m ( 2 ) vs. 2088 251 mm ( 2 ) / m ( 2 ) , both P < 0.0001 ) .
RESULTS	LVI was strongly correlated systolic blood pressure ( men , PE [ 95 % CI ] : 22.8 [ 15.5-30 .2 ] mm ( 2 ) / 10 mmHg ; women , 23.4 [ 18.1-28 .6 ] ) , and antihypertensive medication ( men , 45.2 [ 14.7-75 .8 ] mm ( 2 ) ; women : 46.5 [ 22.7-70 .2 ] , all P < 0.005 ) .
RESULTS	Cholesterol levels were associated with LVI in univariate analysis , however , correlations were low ( R ( 2 ) 0.04 ) .
RESULTS	In multivariable regression , blood pressure , antihypertensive medication and cholesterol levels , remained associated with LVI ( P < 0.05 ) .
RESULTS	LVI was linked with CAC in unadjusted ( men , increase of CAC + 1 by 13.0 % [ 1.4-25 .8 ] with increased LVI by 1 standard deviation of LVI , P = 0.03 ; women , 20.7 % [ 10.0-32 .3 ] , P < 0.0001 ) and risk factor adjusted models ( men , 14.6 % [ 3.7-26 .6 ] , P = 0.007 ) ; women , 17.4 % [ 7.8-27 .8 ] , P = 0.0002 ) .
CONCLUSIONS	Non-contrast cardiac CT derived LV index is associated with body size and hypertension .
CONCLUSIONS	LVI is weakly linked with CAC-score .
CONCLUSIONS	Further studies need to evaluate whether assessment of LV dimensions from cardiac CT helps identifying subjects with increased cardiovascular risk .

###24730621
OBJECTIVE	To compare the outcomes of surgical periodontal therapy with and without initial scaling and root planing .
METHODS	Twenty-four patients with severe chronic periodontitis were enrolled in this pilot , randomized controlled clinical trial .
METHODS	Patients were equally allocated into two treatment groups : Control group was treated with scaling and root planing , re-evaluation , followed by Modified Widman Flap surgery and test group received similar surgery without scaling and root planing .
METHODS	Clinical attachment level , probing depth and bleeding on probing were recorded .
METHODS	Standardized radiographs were analysed for linear bone change from baseline to 6 months .
METHODS	Wound fluid inflammatory biomarkers were also assessed .
RESULTS	Both groups exhibited statistically significant improvement in clinical attachment level and probing depth at 3 and 6 months compared to baseline .
RESULTS	A statistically significant difference in probing depth reduction was found between the two groups at 3 and 6 months in favour of the control group .
RESULTS	No statistically significant differences in biomarkers were detected between the groups .
CONCLUSIONS	Combined scaling and root planing and surgery yielded greater probing depth reduction as compared to periodontal surgery without initial scaling and root planing .

###25439774
OBJECTIVE	Enthusiasm for simulation early in cardiothoracic surgery training is growing , yet evidence demonstrating its utility is limited .
OBJECTIVE	We examined the effect of supervised and unsupervised training on coronary anastomosis performance in a randomized trial among medical students .
METHODS	Forty-five medical students were recruited for this single-blinded , randomized controlled trial using a low-fidelity simulator .
METHODS	After viewing an instructional video , all participants attempted an anastomosis .
METHODS	Subsequently , the participants were randomized to 1 of 3 groups : control ( n = 15 ) , unsupervised training ( n = 15 ) , or supervised training with a cardiothoracic surgeon or fellow ( n = 15 ) .
METHODS	Both the supervised and unsupervised groups practiced for 1 hour per week .
METHODS	After 4 weeks , the participants repeated the anastomosis .
METHODS	All pre - and posttraining performances were videotaped and rated independently by 3 cardiothoracic surgeons blinded to the randomization .
METHODS	All raters scored 13 assessment items on a 1 to 5 ( low-high ) scale along with an overall pass/fail rating .
RESULTS	After the training period , all 3 groups showed significant improvements in composite scores ( control : +0.52 0.69 [ P = .014 ] , unsupervised : +1.05 0.48 [ P < .001 ] , and supervised : +1.10 0.84 [ P < .001 ] ) .
RESULTS	Compared with control group , both supervised ( P = .005 ) and unsupervised trainees ( P = .005 ) demonstrated a significant improvement .
RESULTS	Between the supervised and unsupervised groups there were no statistically significant differences in composite scores .
CONCLUSIONS	Practice on low-fidelity simulators enabled trainees to improve on a broad range of skills ; however , the additional effect of attending-level supervision is limited .
CONCLUSIONS	In an era of increasing staff surgeon responsibilities , unsupervised practice may be sufficient for inexperienced trainees .

###24313610
OBJECTIVE	Cerebral vasospasm following subarachnoid hemorrhage ( SAH ) causes significant morbidity in a delayed fashion .
OBJECTIVE	The authors recently published a new scale that grades the maximum thickness of SAH on axial CT and is predictive of vasospasm incidence .
OBJECTIVE	In this study , the authors further investigate whether different aneurysm locations result in different SAH clot burdens and whether any concurrent differences in ruptured aneurysm location and maximum SAH clot burden affect vasospasm incidence .
METHODS	Two hundred fifty patients who were part of a prospective randomized controlled trial were reviewed .
METHODS	Most outcome and demographic variables were included as part of the prospective randomized controlled trial .
METHODS	Additional variables were also collected at a later time , including vasospasm data and maximum clot thickness .
RESULTS	Aneurysms were categorized into 1 of 6 groups : intradural internal carotid artery aneurysms , vertebral artery ( VA ) aneurysms ( including the posterior inferior cerebellar artery ) , basilar trunk or basilar apex aneurysms , middle cerebral artery aneurysms , pericallosal aneurysms , and anterior communicating artery aneurysms .
RESULTS	Twenty-nine patients with nonaneurysmal SAH were excluded .
RESULTS	Patients with pericallosal aneurysms had the least average maximum clot burden ( 5.3 mm ) , compared with 6.4 mm for the group overall , but had the highest rate of symptomatic vasospasm ( 56 % vs 22 % overall , OR 4.9 , RR 2.7 , p = 0.026 ) .
RESULTS	Symptomatic vasospasm occurrence was tallied in patients with clinical deterioration attributable to delayed cerebral ischemia .
RESULTS	There were no significant differences in maximum clot thickness between aneurysm sites .
RESULTS	Middle cerebral artery aneurysms resulted in the thickest mean maximum clot ( 7.1 mm ) but rates of symptomatic and radiographic vasospasm in this group were statistically no different compared with the overall group .
RESULTS	Vertebral artery aneurysms had the worst 1-year modified Rankin scale ( mRS ) scores ( 3.0 vs 1.9 overall , respectively ; p = 0.0249 ) .
RESULTS	A 1-year mRS score of 0-2 ( good outcome ) was found in 72 % of patients overall , but in only 50 % of those with pericallosal and VA aneurysms , and in 56 % of those with basilar artery aneurysms ( p = 0.0044 ) .
RESULTS	Patients with stroke from vasospasm had higher mean clot thickness ( 9.71 vs 6.15 mm , p = 0.004 ) .
CONCLUSIONS	The location of a ruptured aneurysm minimally affects the maximum thickness of the SAH clot but is predictive of symptomatic vasospasm or clinical deterioration from delayed cerebral ischemia in pericallosal aneurysms .
CONCLUSIONS	The worst 1-year mRS outcomes in this cohort of patients were noted in those with posterior circulation aneurysms or pericallosal artery aneurysms .
CONCLUSIONS	Patients experiencing stroke had higher mean clot burden .

###24959794
OBJECTIVE	To evaluate the short-term benefits of simple relaxation techniques in white-collar employees .
METHODS	The study was a two-arm parallel group randomized controlled trial .
METHODS	152 employees were randomly assigned to receive the 8-week programme ( N = 80 ) ( relaxation breathing and progressive muscle relaxation , twice a day ) or not ( wait-list group N = 72 ) .
METHODS	Self-reported validated measures were used to evaluate perceived stress , health locus of control , job and lifestyle related variables .
METHODS	Saliva cortisol were also sampled and measured .
METHODS	Adjusted mean changes on outcomes were estimated by linear mixed model analysis .
METHODS	127 employees were finally analyzed ( 68 in the intervention and 59 in the control group ) .
RESULTS	Specific stress-related symptoms , psychological job demands and cortisol levels were found to be significantly decreased after 8-weeks in the intervention group .
RESULTS	The result was probably affected by the general socio-economic condition during the study period .
RESULTS	Cortisol levels were also significantly related with age , family situation , gender and sampling time .
CONCLUSIONS	Simple relaxation training ( diaphragmatic breathing and progressive muscle relaxation ) could benefit employees and it is strongly proposed that these and other similar techniques should be tested in various labour settings .

###24661128
BACKGROUND	Faecal short chain fatty acids ( SCFAs ) are produced by the gut microflora .
BACKGROUND	We have previously reported high faecal SCFA levels in children with coeliac disease ( CD ) , indicating alteration in gut microfloral metabolism .
BACKGROUND	Data accumulated over recent decades by us and others suggest that wheat-free oats can safely be included in a gluten-free diet ( GFD ) .
BACKGROUND	However , concerns have been raised with respect to the safety of oats in a subset of coeliacs .
OBJECTIVE	To describe faecal SCFA patterns in children with newly diagnosed CD treated for 1 year with a GFD with or without oats .
METHODS	This report is part of a randomised , double-blind study on the effect of a GFD containing oats ( GFD-oats ) vs. a standard GFD ( GFD-std ) .
METHODS	Faecal samples were received from 34 children in the GFD-oats group and 37 in the GFD-std group at initial diagnosis and/or after 1 year on a GFD .
METHODS	Faecal SCFAs were analysed .
RESULTS	The GFD-std group had a significantly lower total faecal SCFA concentration at 12 months compared with 0 months ( P < 0.05 ) .
RESULTS	In contrast , total SCFA in the GFD-oats group remained high after 1 year on the GFD .
RESULTS	The children in the GFD-oats group had significantly higher acetic acid ( P < 0.05 ) , n-butyric acid ( P < 0.05 ) and total SCFA concentration ( P < 0.01 ) after 1-year diet treatment compared to the GFD-std group .
CONCLUSIONS	Our results indicate that oats do affect the gut microflora function , and that some coeliac children receiving oats may develop gut mucosal inflammation , that may present a risk for future complications .

###25239590
OBJECTIVE	Prucalopride is a selective , high-affinity agonist of the 5-hydroxytryptamine ( serotonin ) receptor 4 that enhances motility in the gastrointestinal tract .
OBJECTIVE	We performed a multicenter , randomized , placebo-controlled , double-blind , phase 3 trial to evaluate the efficacy and safety of prucalopride in children ( 6 months to 18 years old ) with functional constipation .
METHODS	Children with functional constipation , based on the Rome III criteria , were given prucalopride ( children 50 kg were given a 0.04 mg/kg oral solution ; children > 50 kg were given a 2-mg tablet ) or placebo once daily for 8 weeks .
METHODS	The primary efficacy end point was the proportion of children with toileting skills who had a mean of 3 spontaneous bowel movements/week and 1 episode of fecal incontinence/2 weeks , from study weeks 5-8 ( responders ) .
METHODS	Adverse events , clinical laboratory values , and electrocardiograms were monitored .
RESULTS	Efficacy and safety were assessed in 213 children ( 106 prucalopride , 107 placebo ) .
RESULTS	Twenty-five percent were younger than 4 years old , 50 % were 4-11 years old , and 25 % were 12-18 years old ; 55.4 % were girls .
RESULTS	At screening , 62.3 % of patients in the prucalopride group and 55.1 % in the placebo group had a history of fecal incontinence ; 60.4 % and 55.1 % in the prucalopride and placebo groups , respectively , had a mean of 1 spontaneous bowel movements/week .
RESULTS	The proportion of responders was similar between groups ( prucalopride , 17.0 % and placebo , 17.8 % ) .
RESULTS	There were no statistically significant differences in the primary efficacy end point when patients were stratified by sex , age group , or country .
RESULTS	The incidence of treatment-emergent adverse events was similar in the prucalopride ( 69.8 % ) and placebo ( 60.7 % ) groups .
CONCLUSIONS	Prucalopride , although generally well tolerated , was not more effective than placebo in children with functional constipation .
CONCLUSIONS	ClinicalTrials.gov Number : NCT01330381 .

###25085836
BACKGROUND	Epidemiologic studies have reported inconsistent associations of vitamin D and prostate cancer risk ; however , few have adequately controlled for detection bias related to prostate-specific antigen ( PSA ) screening , and the results of many studies may be affected by occult prostate cancers among controls .
METHODS	Data for this nested case-control analysis ( n = 1,695 cases/1 ,682 controls ) are from the Prostate Cancer Prevention Trial .
METHODS	Baseline serum was analyzed for 25-hydroxyvitamin D [ 25 ( OH ) D ] .
METHODS	The presence or absence of cancer was subsequently determined by prostate biopsy .
METHODS	Polytomous logistic regression models were used to estimate associations of 25 ( OH ) D with risk of total , Gleason 2-6 , Gleason 7 , and Gleason 8-10 prostate cancer .
METHODS	Results are presented for placebo and finasteride arms separately and combined .
RESULTS	There were no associations of serum 25 ( OH ) D with total prostate cancer risk .
RESULTS	For Gleason 2-6 cancers , results were inconsistent across treatment arms with a suggestion of increased risk in the placebo arm only ; however , there was no dose-response relationship .
RESULTS	For Gleason 8-10 prostate cancers , 25 ( OH ) D concentrations were associated with a linear decrease in risk among combined treatment arms [ quartile 4 vs. 1 : OR , 0.55 ; 95 % confidence interval ( CI ) , 0.32-0 .94 ; P ( trend ) = 0.04 ] .
RESULTS	These findings were somewhat stronger among men 65 versus 55-64 years at baseline ( quartile 4 vs. 1 : OR , 0.40 ; 95 % CI , 0.18-0 .88 vs. OR , 0.73 ; 95 % CI , 0.35-1 .52 , respectively ; P ( interaction ) = 0.52 ) .
CONCLUSIONS	Higher serum 25 ( OH ) D may modestly increase risk of Gleason 2-6 disease and more substantially reduce risk of Gleason 8-10 prostate cancer .
CONCLUSIONS	Vitamin D may have different effects for different stages of prostate cancers .

###24257813
OBJECTIVE	Antidepressant response varies between patients , possibly due to differences in the rate cytochrome P450 enzymes metabolise antidepressants into inactive compounds .
OBJECTIVE	Drug metabolism rates are influenced by common variants in the genes encoding these enzymes .
OBJECTIVE	However , it remains unclear whether treatment outcomes can be predicted by either CYP450 genotype or antidepressant serum concentration .
METHODS	In GENDEP ( a pharmacogenetic study of depressed individuals treated with either escitalopram or nortriptyline ) , serum concentrations of antidepressants and their primary metabolite were measured after eight weeks treatment and variants in CYP2D6 and CYP2C19 were genotyped .
RESULTS	Amongst patients taking escitalopram ( n = 223 ) , the genotype CYP2C19 was significantly associated with escitalopram serum concentrations and desmethylescitalopram : escitalopram ratio .
RESULTS	For those taking nortriptyline ( n = 161 ) , the CYP2D6 genotype was significantly associated with nortriptyline and 10-hydroxynortriptyline serum concentrations and 10-hydroxynortriptyline : nortrip-tyline ratio .
RESULTS	CYP450 genotypes conferring greater enzyme activity were linked to lower drug serum concentrations and higher metabolite : drug ratios .
RESULTS	Nonetheless , no significant association was found between either CYP450 genotype or antidepressant serum concentration and treatment response .
CONCLUSIONS	While there is a significant relationship between the CYP450 genotype and serum concentrations of escitalopram and nortriptyline , the genotypes are not predictive of differences in treatment response for either drug .
CONCLUSIONS	Furthermore , differences in antidepressant serum concentrations are not associated with variability in treatment response .

###24963566
BACKGROUND	Atrial fibrillation is a leading preventable cause of recurrent stroke for which early detection and treatment are critical .
BACKGROUND	However , paroxysmal atrial fibrillation is often asymptomatic and likely to go undetected and untreated in the routine care of patients with ischemic stroke or transient ischemic attack ( TIA ) .
METHODS	We randomly assigned 572 patients 55 years of age or older , without known atrial fibrillation , who had had a cryptogenic ischemic stroke or TIA within the previous 6 months ( cause undetermined after standard tests , including 24-hour electrocardiography [ ECG ] ) , to undergo additional noninvasive ambulatory ECG monitoring with either a 30-day event-triggered recorder ( intervention group ) or a conventional 24-hour monitor ( control group ) .
METHODS	The primary outcome was newly detected atrial fibrillation lasting 30 seconds or longer within 90 days after randomization .
METHODS	Secondary outcomes included episodes of atrial fibrillation lasting 2.5 minutes or longer and anticoagulation status at 90 days .
RESULTS	Atrial fibrillation lasting 30 seconds or longer was detected in 45 of 280 patients ( 16.1 % ) in the intervention group , as compared with 9 of 277 ( 3.2 % ) in the control group ( absolute difference , 12.9 percentage points ; 95 % confidence interval [ CI ] , 8.0 to 17.6 ; P < 0.001 ; number needed to screen , 8 ) .
RESULTS	Atrial fibrillation lasting 2.5 minutes or longer was present in 28 of 284 patients ( 9.9 % ) in the intervention group , as compared with 7 of 277 ( 2.5 % ) in the control group ( absolute difference , 7.4 percentage points ; 95 % CI , 3.4 to 11.3 ; P < 0.001 ) .
RESULTS	By 90 days , oral anticoagulant therapy had been prescribed for more patients in the intervention group than in the control group ( 52 of 280 patients [ 18.6 % ] vs. 31 of 279 [ 11.1 % ] ; absolute difference , 7.5 percentage points ; 95 % CI , 1.6 to 13.3 ; P = 0.01 ) .
CONCLUSIONS	Among patients with a recent cryptogenic stroke or TIA who were 55 years of age or older , paroxysmal atrial fibrillation was common .
CONCLUSIONS	Noninvasive ambulatory ECG monitoring for a target of 30 days significantly improved the detection of atrial fibrillation by a factor of more than five and nearly doubled the rate of anticoagulant treatment , as compared with the standard practice of short-duration ECG monitoring .
CONCLUSIONS	( Funded by the Canadian Stroke Network and others ; EMBRACE ClinicalTrials.gov number , NCT00846924 . )

###25287825
OBJECTIVE	Acute lymphoblastic leukemia ( ALL ) is the most common pediatric cancer .
OBJECTIVE	Monitoring minimal residual disease ( MRD ) by using real-time quantitative polymerase chain reaction ( RQ-PCR ) provides information for patient stratification and individual risk-directed treatment .
OBJECTIVE	Cooperative studies have documented that measurement of blast clearance from the bone marrow during and after induction therapy identifies patient populations with different risk of relapse .
OBJECTIVE	We explored the possible contribution of measurements of MRD during the course of treatment .
METHODS	We used RQ-PCR to detect MRD in 110 unselected patients treated in Italy in the International Collaborative Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia ( AIEOP-BFM ALL 2000 ) .
METHODS	The trial took place in AIEOP centers during postinduction chemotherapy .
METHODS	Results were categorized as negative , low positive ( below the quantitative range [ < 5 10 ( -4 ) ] ) , or high positive ( 5 10 ( -4 ) ) .
METHODS	Patients with at least one low-positive or high-positive result were assigned to the corresponding subgroup .
RESULTS	Patients who tested high positive , low positive , or negative had significantly different cumulative incidences of leukemia relapse : 83.3 % , 34.8 % , and 8.6 % , respectively ( P < .001 ) .
RESULTS	Two thirds of positive cases were identified within 4 months after induction-consolidation therapy , suggesting that this time frame may be most suitable for cost-effective MRD monitoring , particularly in patients who did not clear their disease at the end of consolidation .
CONCLUSIONS	These findings provide further insights into the dynamic of MRD and the ongoing effort to define molecular relapse in childhood ALL .

###26062880
BACKGROUND	Our objective was to assess therapeutic non-inferiority of dual treatment with lopinavir-ritonavir and lamivudine to triple treatment with lopinavir-ritonavir plus two nucleos ( t ) ides for maintenance of HIV-1 viral suppression .
METHODS	In this randomised , open-label , non-inferiority trial , we recruited patients from 32 HIV units in hospitals in Spain and France .
METHODS	Eligible patients were HIV-infected adults ( aged 18 years ) with HIV-1 RNA of less than 50 copies per mL , for at least 6 months on triple treatment with lopinavir-ritonavir ( twice daily ) plus lamivudine or emtricitabine and a second nucleos ( t ) ide , with no resistance or virological failure to these drugs , and no positive hepatitis B serum surface antigen .
METHODS	Investigators at each centre randomly assigned patients ( 1:1 ; block size of four ; stratified by time to suppression [ < 1 year or > 1 year ] and nadir CD4 cell count [ < 100 cells per L or > 100 cells per L ] ; computer-generated random sequence ) to continue triple treatment or switch to dual treatment ( oral lopinavir 400 mg and oral ritonavir 100 mg twice daily plus oral lamivudine 300 mg once daily ) .
METHODS	The primary endpoint was response to treatment in the intention-to-treat population ( all randomised patients ) at 48 weeks .
METHODS	The non-inferiority margin was 12 % .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01471821 .
RESULTS	Between Oct 1 , 2011 , and April 1 , 2013 , we randomly assigned 250 participants to continue triple treatment ( 127 [ 51 % ] patients ) or switch to dual treatment ( 123 [ 49 % ] patients ) .
RESULTS	In the intention-to-treat population , 110 ( 866 % ) of 127 patients in the triple-treatment group responded to treatment versus 108 ( 878 % ) of 123 in the dual-treatment group ( difference -12 % [ 95 % CI -96 to 73 ] ; p = 092 ) , meeting the criteria for non-inferiority .
RESULTS	Serious adverse events occurred in eight ( 7 % ) patients in the triple-treatment group and five ( 4 % ) in the dual-treatment group ( p = 0515 ) , and study drug discontinuations due to adverse events occurred in four ( 3 % ) in the triple-treatment group and one ( 1 % ) in the dual-treatment group ( p = 0223 ) .
CONCLUSIONS	Dual treatment with lopinavir-ritonavir plus lamivudine has non-inferior therapeutic efficacy and is similarly tolerated to triple treatment .
BACKGROUND	AbbVie and Red Temtica Cooperativa de Investigacin en Sida .

###25386717
BACKGROUND	Factors and outcomes associated with end-of-life decision-making among patients during clinical trials in the intensive care unit are unclear .
OBJECTIVE	We sought to determine patterns and outcomes of Do Not Resuscitate ( DNR ) decisions among critically ill patients with acute respiratory distress syndrome ( ARDS ) enrolled in a clinical trial .
METHODS	We performed a secondary analysis of data from the ARDS Network Fluid and Catheter Treatment Trial ( FACTT ) , collected between 2000 and 2005 .
METHODS	We calculated mortality outcomes stratified by code status , and compared baseline characteristics of patients who became DNR during the trial with participants who remained full code .
RESULTS	Among 809 FACTT participants with a code status recorded , 232 ( 28.7 % ) elected DNR status .
RESULTS	Specifically , 37 ( 15.9 % ) chose to withhold cardiopulmonary resuscitation alone , 44 ( 19.0 % ) elected to withhold some life support measures in addition to cardiopulmonary resuscitation , and 151 ( 65.1 % ) had life support withdrawn .
RESULTS	Admission severity of illness as measured by APACHE III score was strongly associated with election of DNR status ( odds ratio , 2.2 ; 95 % confidence interval , 1.85-2 .62 ; P < 0.0001 ) .
RESULTS	Almost all ( 97.0 % ; 225 of 232 ) patients who selected DNR status died , and 79 % ( 225 of 284 ) of patients who died during the trial were DNR .
RESULTS	Among patients who chose DNR status but did not elect withdrawal of life support , 91 % ( 74 of 81 ) died .
CONCLUSIONS	The vast majority of deaths among clinical trial patients with ARDS were preceded by a DNR order .
CONCLUSIONS	Unlike other studies of end-of-life decision-making in the intensive care unit , nearly all patients who became DNR died .
CONCLUSIONS	The impact of variation of practice in end-of-life decision-making during clinical trials warrants further study .

###24503952
BACKGROUND	Etravirine ( ETR ) was approved for patients with virological failure and antiretroviral resistance mutations .
BACKGROUND	It has also shown antiviral efficacy in antiretroviral-nave patients .
BACKGROUND	However , data on the switching from protease inhibitors ( PI ) to ETR are lacking .
METHODS	HIV-1-infected patients with suppressed viral load ( VL ) during a PI-containing regimen ( > 12 months ) and no previous virological failure were randomized to switch from the PI to ETR ( 400 mg/day , dissolved in water ) ( ETR group , n = 22 ) or to continue with the same regimen ( control group , n = 21 ) .
METHODS	Percentage of patients with VL 50 copies/mL were assessed at week 48 , as well as changes in CD4 T-cell counts and metabolic profile .
RESULTS	We included 43 patients [ 72.9 % male , 46.3 ( 42.2 ; 50.6 ) years ] .
RESULTS	Two patients receiving ETR ( grade-1 diarrhea and voluntary discontinuation ) and another in the control group ( simplification ) discontinued therapy early .
RESULTS	No patients presented virological failure ( two consecutive VL > 50 copies/mL ) ; treatment was successful in 95.2 % of the control group and 90.9 % of the ETR group ( intention-to-treat analysis , missing = failure ) ( p = 0.58 ) .
RESULTS	CD4 + T-cell counts did not significantly vary [ +49 cells/L in the ETR group ( p = 0.25 ) and -4 cells/L in the control group ( p = 0.71 ) ] .
RESULTS	The ETR group showed significant reductions in cholesterol ( p < 0.001 ) , triglycerides ( p = < 0.001 ) , and glycemia ( p = 0.03 ) and higher satisfaction ( 0-10 scale ) ( p = 0.04 ) .
RESULTS	Trough plasma concentrations of ETR were similar to observed in studies using ETR twice daily .
CONCLUSIONS	Switch from a PI-based regimen to a once-daily combination based on ETR maintained undetectable VL during 48 weeks in virologically suppressed HIV-infected patients while lipid profile and patient satisfaction improved significantly .
BACKGROUND	ClinicalTrials.gov NCT01034917 .

###25199825
OBJECTIVE	The purpose of this study was to determine the effects of deep dry needling ( DDN ) on spasticity , pressure sensitivity , and plantar pressure in patients who have had stroke .
METHODS	A randomized controlled trial was conducted .
METHODS	Thirty-four patients who previously had a stroke were randomly assigned either an experimental group that received a single session of DDN over the gastrocnemius and tibialis anterior muscles on the spastic leg or a control group that received no intervention .
METHODS	Spasticity ( evaluated with the Ashworth Scale ) ; pressure pain thresholds over the deltoid muscle , second metacarpal , and tibialis anterior muscle ; and plantar pressure ( baropodometry ) were collected by a blinded assessor before and 10 minutes after intervention .
RESULTS	A greater number of individuals receiving DDN exhibited decreased spasticity after the intervention ( P < .001 ) .
RESULTS	The analysis of covariance showed that pressure pain thresholds increased bilaterally in patients receiving DDN compared with those who did not receive the intervention ( P < .001 ) .
RESULTS	The analysis of covariance also found that patients receiving DDN experienced bilateral increases of support surface in the forefoot , unilateral increase of the support surface in the rear foot of the treated ( affected ) side , and bilateral decreases in mean pressure ( all , P < .02 ) as compared with those who did not receive DDN .
CONCLUSIONS	Our results suggest that a single session of DDN decreases spasticity and widespread pressure sensitivity in individuals with poststroke spasticity .
CONCLUSIONS	Deep dry needling also induced changes in plantar pressure by increasing the support surface and decreasing the mean pressure .

###24275233
OBJECTIVE	To compare patient preference for either sharp incision with scissors or blunt manual cleavage of the fascia at cesarean delivery in a randomized controlled trial in which each woman was her own control .
METHODS	Women undergoing primary cesarean delivery ( n = 34 ) were randomized to side distribution of sharp or blunt incision of the fascia ( sharp right and blunt left or blunt right and sharp left ) and followed three months postoperatively .
METHODS	The primary outcome was patient preference for the right or left side of the scar 3 months postoperatively and modeled by polytomous logistic regression .
METHODS	The secondary outcome was difference in pain between the two sides measured on a 0.0-10 .0 numerical rating scale at 1 , 3 , and 7 days and 1 and 3 months postoperatively .
METHODS	Pain scores were analyzed with a Wilcoxon signed rank test .
RESULTS	28 cases were analyzed and no significant difference was found in preference after three months .
RESULTS	Nine women preferred the sharp ( 32 % , 95 % CI 16-52 % ) and 7 the blunt side ( 25 % , 95 % CI 11-45 % ) ( P = 0.804 ) .
RESULTS	Pain scores did not differ significantly between the two sides at any time postoperatively either at rest or during mobilization .
CONCLUSIONS	No significant difference was found in patient preference with regard to sharp or blunt incision of the fascia , nor was there a significant difference in postoperative pain scores .
BACKGROUND	ClinicalTrials.gov : www.clinicaltrials.org ; NCT01297725 .

###25627259
OBJECTIVE	Fear of childbirth is a common reason for seeking cesarean section .
OBJECTIVE	It is important to consider outcomes and costs associated with alternative treatment and delivery mode .
OBJECTIVE	We compared well-being and costs of group psychoeducation and conventional care for fear of childbirth .
METHODS	Randomized controlled trial .
METHODS	A total of 371 nulliparous women scoring over the 95th centile in the Wijma Delivery Expectancy Questionnaire ( W-DEQ ) during the first trimester .
METHODS	Finland , data from obstetrical patient records and questionnaires .
METHODS	Randomization to group psychoeducation with relaxation ( six sessions during pregnancy , one after childbirth , n = 131 ) , or surveillance and referral on demand ( n = 240 ) .
METHODS	All costs in maternity care during pregnancy , delivery and postnatally according to Diagnoses Related Groups .
METHODS	Life satisfaction and general well-being 3 months after childbirth ( by a Satisfaction with Life Scale and Well-being Visual Analogue Scale ) .
RESULTS	The groups did not differ in total direct costs ( 3786/woman in psychoeducative group and 3830/woman in control group ) , nor in life satisfaction or general well-being .
RESULTS	Although only 76 ( 30 % ) of the women assigned to the surveillance were referred to special maternity care and 36 ( 15 % ) attended advanced prenatal classes , costs in the psychoeducation group did not exceed the costs of the controls , mostly because of the greater number of uncomplicated vaginal deliveries ( 63 % vs. 47 % , p = 0.005 ) .
CONCLUSIONS	Through an association with safer childbirth and equal well-being after delivery , psychoeducative group treatment for nulliparous women with fear of childbirth can be a recommended choice for the same overall costs as conventional treatment .

###25764482
OBJECTIVE	Given the limitations in health care resources , quality-of-life measures for interventions have gained importance .
OBJECTIVE	To determine whether vision-related quality-of-life outcomes were different between the natamycin and voriconazole treatment arms in the Mycotic Ulcer Treatment Trial I , as measured by an Indian Vision Function Questionnaire .
METHODS	Secondary analysis ( performed October 11-25 , 2014 ) of a double-masked , multicenter , randomized , active comparator-controlled , clinical trial at multiple locations of the Aravind Eye Care System in South India that enrolled patients with culture - or smear-positive filamentous fungal corneal ulcers who had a baseline visual acuity of 20/40 to 20/400 ( logMAR of 0.3-1 .3 ) .
METHODS	Study participants were randomly assigned to topical voriconazole , 1 % , or topical natamycin , 5 % .
METHODS	Subscale score on the Indian Vision Function Questionnaire from each of the 4 subscales ( mobility , activity limitation , psychosocial impact , and visual function ) at 3 months .
RESULTS	A total of 323 patients were enrolled in the trial , and 292 ( 90.4 % ) completed the Indian Vision Function Questionnaire at 3 months .
RESULTS	The majority of study participants had subscale scores consistent with excellent function .
RESULTS	After adjusting for baseline visual acuity and organism , we found that study participants in the natamycin-treated group scored , on average , 4.3 points ( 95 % CI , 0.1-8 .5 ) higher than study participants in the voriconazole-treated group ( P = .046 ) .
RESULTS	In subgroup analyses looking at ulcers caused by Fusarium species and adjusting for baseline best spectacle-corrected visual acuity , the natamycin-treated group scored 8.4 points ( 95 % CI , 1.9-14 .9 ) higher than the voriconazole-treated group ( P = .01 ) .
RESULTS	Differences in quality of life were not detected for patients with Aspergillus or other non-Fusarium species as the causative organism ( 1.5 points [ 95 % CI , -3.9 to 6.9 ] ; P = .52 ) .
CONCLUSIONS	We found evidence of improvement in vision-related quality of life among patients with fungal ulcers who were randomly assigned to natamycin compared with those randomly assigned to voriconazole , and especially among patients with Fusarium species as the causative organism .
CONCLUSIONS	Incorporation of quality-of-life measures in clinical trials is important to fully evaluate the effect of the studied interventions .
BACKGROUND	clinicaltrials.gov Identifier : NCT00996736 .

###24667592
OBJECTIVE	The goal of the study was to examine if intake of Lactobacillus plantarum can accelerate clearance of nontyphoid Salmonella and reduce infection-related symptoms .
BACKGROUND	Nontyphoid Salmonella is a major cause of gastroenteritis worldwide .
BACKGROUND	Few studies have explored the effect of probiotics in these infections .
METHODS	Patients with Salmonella infection were randomized to daily intake of 5 10 colony forming units of freeze-dried Lactobacillus plantarum 299 v or placebo .
METHODS	Symptoms were recorded daily .
METHODS	Feces were cultured weekly .
METHODS	Treatment continued until 4 consecutive stool cultures negative for Salmonella had been obtained .
RESULTS	The treatment and placebo groups did not differ significantly with regard to time to clearance of Salmonella , or time to resolution of symptoms .
RESULTS	Irrespective of treatment , women tended to clear Salmonella more rapidly than men ( 19 vs. 28 d , P = 0.18 ) , despite a longer diarrheal phase ( 5 vs. 3 days after inclusion , P = 0.001 ) .
RESULTS	After Salmonella clearance ( postinfectious phase ) , women experienced loose stools , nausea , and flatulence more frequently than men .
RESULTS	In women , L. plantarum treatment was associated with more abdominal pain , whereas in men L. plantarum treatment reduced the prevalence of hard stools , and increased the presence of diarrheal symptoms in the postinfectious phase .
CONCLUSIONS	Gender , but not administration of the probiotic strain L. plantarum 299 v , may influence acute symptoms during Salmonella infection and possibly clearance of Salmonella .
CONCLUSIONS	Symptoms in the postinfectious phase were modified by the probiotics in a gender-specific way , but our results give little support for positive effects of L. plantarum 299 v treatment in nontyphoid salmonellosis .

###24314909
BACKGROUND	Swallowing problems following stroke may result in increased risk of aspiration pneumonia , malnutrition , and dehydration .
OBJECTIVE	Our hypothesis was that three neurostimulation techniques would produce beneficial effects on chronic dysphagia following stroke through a common brain mechanism that would predict behavioral response .
METHODS	In 18 dysphagic stroke patients ( mean age : 66 3 years , 3 female , time-post-stroke : 63 15 weeks [ SD ] ) , pharyngeal electromyographic responses were recorded after single-pulse transcranial magnetic stimulation ( TMS ) over the pharyngeal motor cortex , to measure corticobulbar excitability before , immediately , and 30 min , after real and sham applications of neurostimulation .
METHODS	Patients were randomized to a single session of either : pharyngeal electrical stimulation ( PES ) , paired associative stimulation ( PAS ) or repetitive TMS ( rTMS ) .
METHODS	Penetration-aspiration scores and bolus transfer timings were assessed before and after both real and sham interventions using videofluoroscopy .
RESULTS	Corticobulbar excitability of pharyngeal motor cortex was beneficially modulated by PES , PAS and to a lesser extent by rTMS , with functionally relevant changes in the unaffected hemisphere .
RESULTS	Following combining the results of real neurostimulation , an overall increase in corticobulbar excitability in the unaffected hemisphere ( P = .005 , F1 ,17 = 10.6 , ANOVA ) with an associated 15 % reduction in aspiration ( P = .005 , z = -2.79 ) was observed compared to sham .
CONCLUSIONS	In this mechanistic study , an increase in corticobulbar excitability the unaffected projection was correlated with the improvement in swallowing safety ( P = .001 , rho = -.732 ) , but modality-specific differences were observed .
CONCLUSIONS	Paradigms providing peripheral input favored change in neurophysiological and behavioral outcome measures in chronic dysphagia patients .
CONCLUSIONS	Further larger cohort studies of neurostimulation in chronic dysphagic stroke are imperative .

###25517733
OBJECTIVE	Active immunization , or vaccination , with tumor necrosis factor ( TNF ) - Kinoid ( TNF-K ) is a novel approach to induce polyclonal anti-TNF antibodies in immune-mediated inflammatory diseases .
OBJECTIVE	This study was performed to transfer the proof of concept obtained in mice model of rheumatoid arthritis ( RA ) into human .
OBJECTIVE	We designed a pilot study to demonstrate the feasibility of therapeutic vaccination in RA .
METHODS	This was a phase IIa , placebo-controlled , multicenter study in adults with RA who previously experienced secondary failure of TNF antagonists .
METHODS	Patients were immunized intramuscularly with 2 or 3 doses of placebo ( n = 10 ) or 90 ( n = 6 ) , 180 ( n = 12 ) , or 360 g TNF-K ( n = 12 ) .
METHODS	The primary objective was to identify the best dose and schedule based on anti-TNF antibody titers .
METHODS	Clinical symptoms and safety were assessed during 12 months and solicited reactions for 7 days after each injection .
RESULTS	The highest anti-TNF antibody response was detected in patients immunized with 360 g TNF-K and with 3 injections , although this difference was not significant with all other groups .
RESULTS	Similar proportions of patients receiving TNF-K and placebo reported adverse events up to month 12 .
RESULTS	Serious adverse events were reported by 4 patients treated with TNF-K ( 13.3 % ) and 3 treated with placebo ( 30.0 % ) , all unrelated to treatment .
RESULTS	At month 12 , DAS28-CRP , tender and swollen joint counts , and HAQ scores decreased significantly more in patients who exhibited anti-TNF antibody response than in patients who did not .
CONCLUSIONS	TNF-K therapeutic vaccination induced dose - and schedule-dependent anti-TNF antibodies in RA patients and was well tolerated .
CONCLUSIONS	Patients who developed anti-TNF antibodies showed a trend toward clinical improvement .
CONCLUSIONS	Although the most aggressive dose and schedule , i.e. 360 mg dose administered 3 times , did show a strong trend of higher antibody response , further studies are warranted to examine even higher and more frequent doses in order to establish the best conditions for clinical improvement .
BACKGROUND	ClinicalTrials.gov NCT01040715 .

###24817601
OBJECTIVE	We evaluated the population pharmacokinetics ( PPK ) and exposure-response relationship of imatinib mesylate in Iranian patients with chronic myeloid leukemia ( CML ) .
OBJECTIVE	This study was designed to assess steady state ( SS ) imatinib trough concentrations ( Cmin ) and pharmacokinetics parameters of imatinib in patients with CML in chronic phase after at least 12-month treatment .
METHODS	Plasma concentrations from a randomized controlled trial consist of 61 patients who received oral imatinib at doses ranged between 300 and 800 mg in various dosing interval , which were quantified using a validated reversed-phase high-performance liquid chromatographic method with UV detection method on different occasions at SS and evaluated using PPK model .
RESULTS	A one-compartment model with zero-order absorption and a lag time was sufficient in describing the concentration-time profile .
RESULTS	Inter-individual variability ( IIV ) was modeled for all parameters .
RESULTS	Oral clearance ( CL/F ) and the volume of distribution ( V/F ) were estimated to 10.8 L/h with 30 % IIV and 265 L with 53 % IIV , respectively .
RESULTS	Inter-occasion variability ( IOV ) was included in CL/F ( 17 % ) and V/F ( 22 % ) .
RESULTS	The proportional residual error of the model was 8 % .
CONCLUSIONS	Simulation analysis from individual parameters shows exposure to imatinib is highly variable among patients .
CONCLUSIONS	Imatinib trough plasma levels < 1,257 ng/mL were associated with lower rates of major molecular response .
CONCLUSIONS	Because of the wide IIV compared with IOV with imatinib in our study , trough levels may play a role in investigating instances of suboptimal response .

###24956325
BACKGROUND	Diabetes prevention is a public health priority that is dependent upon the reach , effectiveness , and cost of intervention strategies .
BACKGROUND	However , understanding each of these outcomes within the context of randomized controlled trials is problematic .
OBJECTIVE	To describe the methods and design of a hybrid preference/randomized control trial using the RE-AIM framework .
METHODS	The trial , which was developed using the RE-AIM framework , will contrast the effects of 3 interventions : ( 1 ) a standard care , small group , diabetes prevention education class ( SG ) , ( 2 ) the small group intervention plus 12 months of interactive voice response telephone follow-up ( SG-IVR ) , and ( 3 ) a DVD version of the small group intervention with the same IVR follow-up ( DVD-IVR ) .
METHODS	Each intervention includes personal action planning with a focus on key elements of the lifestyle intervention from the Diabetes Prevention Program ( DPP ) .
METHODS	Adult patients at risk for diabetes will be randomly assigned to either choice or RCT .
METHODS	Those assigned to choice ( n = 240 ) will have the opportunity to choose between SG-IVR and DVD-IVR .
METHODS	Those assigned to RCT group ( n = 360 ) will be randomly assigned to SG , SG-IVR , or DVD-IRV .
METHODS	Assessment of primary ( weight loss , reach , & cost ) and secondary ( physical activity , & dietary intake ) outcomes will occur at baseline , 6 , 12 , and 18 months .
CONCLUSIONS	This will be the first diabetes prevention trial that will allow the research team to determine the relationships between reach , effectiveness , and cost of different interventions .

###24569045
BACKGROUND	Agomelatine was efficacious in reducing symptoms in a short-term placebo-controlled trial in generalized anxiety disorder ( GAD ) and in preventing relapse in a longer term placebo-controlled study .
BACKGROUND	An additional short-term placebo-controlled study is required by regulatory agencies to confirm the efficacy of agomelatine in GAD .
METHODS	This 12-week , placebo-controlled , double-blind , randomized , parallel group , international , multicenter study was designed to confirm the efficacy of agomelatine 25-50 mg/d in the treatment of patients with a primary DSM-IV-TR diagnosis of GAD .
METHODS	The primary outcome measure was the Hamilton Anxiety Rating Scale ( HARS ) total score .
METHODS	Assay sensitivity was evaluated by including an escitalopram ( 10-20 mg/d ) group .
METHODS	The study was undertaken in 45 clinical centers in Argentina , Czech Republic , Finland , South Korea , Poland , Russia , and Slovakia from April 2010 to July 2011 .
RESULTS	One hundred thirty-nine outpatients were included in the agomelatine group , 131 in the placebo group , and 142 in the escitalopram group .
RESULTS	Agomelatine significantly reduced mean ( SD ) HARS total score ( agomelatine-placebo difference : 4.71 [ 1.03 ] , P < .0001 ) and had significant effects on secondary outcome measures , including psychic and somatic HARS subscales , response rate ( estimate [ standard error ] ) ( agomelatine-placebo difference : 27.4 % [ 5.9 % ] , P < .0001 ) , remission on the HARS ( agomelatine-placebo difference : 16.8 % [ 5.4 % ] , P = .002 ) , Clinical Global Impressions-Severity of Illness scale ( CGI-S ) ( P < .001 ) , functional impairment ( P < .0001 ) , and sleep quality ( P < .001 ) .
RESULTS	Findings were confirmed in the subset of more severely ill patients ( HARS total score 25 with or without CGI-S 5 at baseline ) .
RESULTS	Agomelatine was well tolerated by patients , with no more adverse events than placebo .
RESULTS	Escitalopram was similarly efficacious but was accompanied by a higher incidence of adverse events compared to placebo .
CONCLUSIONS	In clinical practice , agomelatine has at least similar efficacy to that of escitalopram for the short-term treatment of GAD and is well tolerated .
BACKGROUND	Controlled-Trials .
BACKGROUND	com identifier : ISRCTN03554974 .

###24506809
BACKGROUND	Photodynamic therapy ( PDT ) is followed by significant inflammation .
BACKGROUND	Protoporphyrin ( Pp ) IX is still formed in the skin after PDT and patients are sensitive to daylight 24-48 h after treatment .
BACKGROUND	Exposure to daylight after PDT may therefore increase inflammation .
OBJECTIVE	To investigate whether protection with inorganic sunscreen , foundation or light-blocking plaster after PDT can reduce inflammation caused by daylight-activated PpIX .
METHODS	On the right arm of 15 subjects with sun-damaged skin , four identical squares ( 3 3 cm ) were given conventional PDT treatment .
METHODS	Immediately after red-light illumination the squares were either left unprotected or protected by inorganic sunscreen [ sun protection factor ( SPF ) 50 ] , foundation ( SPF50 ) or light-blocking plaster .
METHODS	The skin was then illuminated with artificial daylight for 2 h and afterwards covered for 24 h. Fluorescence and erythema ( inflammation ) were measured with a fluorescence camera and a reflectance meter .
RESULTS	PpIX was significantly reduced after artificial daylight illumination ( P < 00004 ) , except on the square protected with light-blocking silver plaster , where it had increased ( P = 009 ) .
RESULTS	The increased erythema 24 h after treatment was reduced by 19 % with the sunscreen ( P = 029 ) , by 27 % with the foundation ( P = 010 ) and by 44 % with the silver plaster ( P = 0002 ) .
CONCLUSIONS	Artificial daylight exposure after conventional PDT increases skin erythema .
CONCLUSIONS	Light-blocking plaster gives more effective protection against post-PDT daylight exposure than inorganic sunscreen and foundation .
CONCLUSIONS	In practice such full protection can be achieved by use of sun-blocking clothes or daylight avoidance for 24 h.

###25412401
BACKGROUND	Less than half of breast cancer survivors with lymphedema perform self-care as directed .
BACKGROUND	Effective lymphedema self-care is required to obtain acceptable health outcomes .
BACKGROUND	Self-Regulation Theory suggests that objective self-measurement of physiological conditions is necessary to promote self-regulation/self-care .
BACKGROUND	Bioelectric Impedance Spectroscopy ( BIS ) represents a potential self-measurement method for arm lymphedema .
BACKGROUND	The purpose of this pilot study was to examine the impact of arm self-measurement on daily self-care activities and health outcomes in breast cancer survivors with lymphedema .
RESULTS	A pilot randomized clinical trial compared outcomes between breast cancer survivors with lymphedema who self-monitored for 3 months and breast cancer survivors with lymphedema who did not self-monitor .
RESULTS	Data were collected at baseline , months 1 , 2 , 3 , and 4 .
RESULTS	Eighty-six women with lymphedema were screened : 62 were eligible , 50 were enrolled , 10 withdrew , and 1 had incomplete data , thus N = 39 .
RESULTS	No between group differences were noted in participant characteristics .
RESULTS	The self-monitored group had higher days of garment use ( p = 0.005 ) that remained stable after self-monitoring stopped .
RESULTS	The median number of days of simple manual lymphatic drainage increased in the intervention group ( p = 0.004 ) with a downward trend after self-monitoring ceased .
CONCLUSIONS	Objective self-monitoring of arms using BIS is possible .
CONCLUSIONS	Self-monitoring may positively impact self-care behaviors .
CONCLUSIONS	Highly symptomatic patients may require coaching or other psychological support to improve their self-care .
CONCLUSIONS	Studies that combine a cognitive behavioral therapy component along with self-measurement should be considered as potential interventions to impact lymphedema self-care .
CONCLUSIONS	Other applications of self-monitoring warrant investigation .

###25449224
OBJECTIVE	To determine whether the application of occlusive wrap applied immediately after birth will reduce mortality in very preterm infants .
METHODS	This was a prospective randomized controlled trial of infants born 24 0/7 to 27 6/7 weeks ' gestation who were assigned randomly to occlusive wrap or no wrap .
METHODS	The primary outcome was all cause mortality at discharge or 6 months ' corrected age .
METHODS	Secondary outcomes included temperature , Apgar scores , pH , base deficit , blood pressure and glucose , respiratory distress syndrome , bronchopulmonary dysplasia , seizures , patent ductus arteriosus , necrotizing enterocolitis , gastrointestinal perforation , intraventricular hemorrhage , cystic periventricular leukomalacia , pulmonary hemorrhage , retinopathy of prematurity , sepsis , hearing screen , and pneumothorax .
RESULTS	Eight hundred one infants were enrolled .
RESULTS	There was no difference in baseline population characteristics .
RESULTS	There were no significant differences in mortality ( OR 1.0 , 95 % CI 0.7-1 .5 ) .
RESULTS	Wrap infants had statistically significant greater baseline temperatures ( 36.3 C wrap vs 35.7 C no wrap , P < .0001 ) and poststabilization temperatures ( 36.6 C vs 36.2 C , P < .001 ) than nonwrap infants .
RESULTS	For the secondary outcomes , there was a significant decrease in pulmonary hemorrhage ( OR 0.6 , 95 % CI 0.3-0 .9 ) in the wrap group and a significant lower mean one minute Apgar score ( P = .007 ) in the wrap group .
RESULTS	The study was stopped early because continued enrollment would not result in the attainment of a significant difference in the primary outcome .
CONCLUSIONS	Application of occlusive wrap to very preterm infants immediately after birth results in greater mean body temperature but does not reduce mortality .

###25200142
BACKGROUND	Nondisabling cerebrovascular events represent the largest group of cerebrovascular disease with a high risk of recurrent stroke .
BACKGROUND	A recent trial demonstrated that dual-antiplatelet therapy ( clopidogrel and aspirin ) , compared with aspirin monotherapy , reduced the risk of recurrent stroke and was not associated with increased risk of hemorrhagic events .
BACKGROUND	Apixaban , a new oral anticoagulant , has been proven to be as safe and effective as traditional anticoagulants while carrying significantly less risk of intracranial hemorrhage .
BACKGROUND	Patients with transient ischemic attack ( TIA ) / minor stroke might benefit from apixaban treatment ; therefore , an adequately powered randomized study is needed .
RESULTS	The ADANCE [ Apixaban Versus Dual-antiplatelet Therapy ( Clopidogrel and Aspirin ) in Acute Non-disabling Cerebrovascular Events ] study is a randomized , double-blind clinical trial with a target enrollment of 5,500 patients .
RESULTS	A 21-day regimen of apixaban or of clopidogrel with aspirin followed by clopidogrel on days 22 through 90 will be administered to randomized participants with acute TIA or minor ischemic stroke .
RESULTS	The primary efficacy endpoint is the percentage of patients with any new stroke ( ischemic or hemorrhage ) , including fatal stroke , at day 21 .
RESULTS	Study visits will be performed on the day of randomization , and at days 7 , 22 , and 90 .
CONCLUSIONS	The novel oral anticoagulant apixaban has been widely used with fewer adverse effects than traditional anticoagulants .
CONCLUSIONS	We designed the ADANCE trial to observe the effects of apixaban on recurrent stroke after TIA or minor stroke .
CONCLUSIONS	The results should better guide the selection of anticoagulant or dual-antiplatelet therapy for patients with acute TIA or minor ischemic stroke .

###24356798
OBJECTIVE	This study aimed to evaluate the identification rate and surgery time of sentinel lymph node biopsy ( SLNB ) by a multimodal method ( MMM ) using a mixture of indocyanine green ( ICG ) , radioisotope ( RI ) , and blue dye ( BD ) compared with the RI alone .
METHODS	In this phase II randomized study , 86 patients with clinically node-negative breast cancer were enrolled and received SLNB with either MMM or RI .
METHODS	We compared the identification rate , number of sentinel lymph nodes ( SLNs ) , and detection time of SLNB and evaluated the safety .
RESULTS	The mean age of the MMM group and RI group was 48.2 and 51.0 years ( p = 0.12 ) , respectively .
RESULTS	There were no differences in histopathologic factors , including tumor size , node positivity , and hormone receptor positivity between groups .
RESULTS	SLNs were identified in all patients of both groups ( 100 % in the MMM group and 100 % in the RI group ) .
RESULTS	The average number of SLNs in the MMM group was more than that in the RI group ( 3.4 1.37 vs. 2.3 1.04 , respectively ; p < 0.001 ) .
RESULTS	The time to detect the first sentinel lymph node was similar in each group ( 6.5 5.16 vs. 8.0 4.35 min ; p = 0.13 ) .
RESULTS	In the MMM group , percutaneous lymphatic drainage was visualized by fluorescent imaging in 90.7 % ( 39 of 43 patients ) .
RESULTS	During and after the operation , there were no complications , including allergic reactions , skin staining , or necrosis .
CONCLUSIONS	This study is the first randomized trial that compared MMM using ICG , RI , and BD and the conventional RI method for SLNB .
CONCLUSIONS	MMM is a feasible and safe method for SLNB .

###25139609
BACKGROUND	Glucose measurement in intensive care medicine is performed intermittently with the risk of undetected hypoglycemia .
BACKGROUND	The workload for the ICU nursing staff is substantial .
BACKGROUND	Subcutaneous continuous glucose monitoring ( CGM ) systems are available and may be able to solve some of these issues in critically ill patients .
METHODS	In a randomized controlled design in a mixed ICU in a teaching hospital we compared the use of subcutaneous CGM with frequent point of care ( POC ) to guide insulin treatment .
METHODS	Adult critically ill patients with an expected stay of more than 24 hours and in need of insulin therapy were included .
METHODS	All patients received subcutaneous CGM .
METHODS	CGM data were blinded in the control group , whereas in the intervention group these data were used to feed a computerized glucose regulation algorithm .
METHODS	The same algorithm was used in the control group fed by intermittent POC glucose measurements .
METHODS	Safety was assessed with the incidence of severe hypoglycemia ( < 2.2 mmol/L ) , efficacy with the percentage time in target range ( 5.0 to 9.0 mmol/L ) .
METHODS	In addition , we assessed nursing workload and costs .
RESULTS	In this study , 87 patients were randomized to the intervention and 90 to the control group .
RESULTS	CGM device failure resulted in 78 and 78 patients for analysis .
RESULTS	The incidence of severe glycemia and percentage of time within target range was similar in both groups .
RESULTS	A significant reduction in daily nursing workload for glucose control was found in the intervention group ( 17 versus 36 minutes ; P < 0.001 ) .
RESULTS	Mean daily costs per patient were significantly reduced with EUR 12 ( 95 % CI -32 to -18 , P = 0.02 ) in the intervention group .
CONCLUSIONS	Subcutaneous CGM to guide insulin treatment in critically ill patients is as safe and effective as intermittent point-of-care measurements and reduces nursing workload and daily costs .
CONCLUSIONS	A new algorithm designed for frequent measurements may lead to improved performance and should precede clinical implementation .
BACKGROUND	Clinicaltrials.gov , NCT01526044 .
BACKGROUND	Registered 1 February 2012 .

###24856854
BACKGROUND	Regular exercise and dietary practices have been shown to affect the health-related quality of life ( HRQOL ) and survival of breast cancer patients .
OBJECTIVE	The current study aimed to investigate whether the WSEDI was a feasible and primarily effective method for promoting exercise and dietary behaviours for breast cancer patients .
METHODS	A 12-week randomized , controlled trial .
METHODS	Oncology outpatient treatment clinics at 3 university hospitals and 1 National Cancer Center in South Korea .
METHODS	Fifty-nine breast cancer patients who had received curative surgery and completed primary cancer treatment within 12 months prior to the study and who had been diagnosed with stage 0-III cancers within 2 years prior to the study were recruited .
METHODS	Participants were randomly assigned to either the intervention group , which used a Web-based self-management exercise and diet intervention program incorporating transtheoretical model ( TTM ) - based strategies ( n = 29 ) , or to the control group , which used a 50-page educational booklet on exercise and diet ( n = 28 ) .
METHODS	The intervention efficacy was measured at the baseline and 12 weeks via a Web-based survey that addressed the promotion of exercise and consumption of 5 servings of fruits and vegetables ( F&V ) per day , dietary quality , HRQOL , anxiety , depression , fatigue , motivational readiness , and self-efficacy .
RESULTS	The proportion of subjects who performed at least moderate-intensity aerobic exercise for at least 150 min per week ; ate 5 servings of F&V per day ; and had overall improvements in dietary quality , physical functioning and appetite loss ( HRQOL ) , fatigue , and motivational readiness was greater in the intervention group than in the control group .
RESULTS	The self-efficacy with respect to exercise and F&V consumption was greater in the intervention group than in the control group .
RESULTS	A Web-based program that targets changes in exercise and dietary behaviours might be effective for breast cancer survivors if the TTM theory has been used to inform the program strategy , although further research with a larger sample size is required to enable definitive conclusions .

###24559035
BACKGROUND	Fidelity assessments are integral to intervention research but few published trials report these processes in detail .
BACKGROUND	We included plans for fidelity monitoring in the design of a community-based intervention trial .
METHODS	The study design was a randomized clinical trial of an intervention provided to low-income women to increase utilization of dental care during pregnancy ( mother ) or the postpartum ( child ) period .
METHODS	Group assignment followed a 2 2 factorial design in which participants were randomly assigned to receive either brief Motivational Interviewing ( MI ) or Health Education ( HE ) during pregnancy ( prenatal ) and then randomly reassigned to one of these groups for the postpartum intervention .
METHODS	The study setting was four county health departments in rural Oregon State , USA .
METHODS	Counseling was standardized using a step-by-step manual .
METHODS	Counselors were trained to criteria prior to delivering the intervention and fidelity monitoring continued throughout the implementation period based on audio recordings of counselor-participant sessions .
METHODS	The Yale Adherence and Competence Scale ( YACS ) , modified for this study , was used to code the audio recordings of the counselors ' delivery of both the MI and HE interventions .
METHODS	Using Interclass Correlation Coefficients totaling the occurrences of specific MI counseling behaviors , ICC for prenatal was .93 , for postpartum the ICC was .75 .
METHODS	Participants provided a second source of fidelity data .
METHODS	As a second source of fidelity data , the participants completed the Feedback Questionnaire that included ratings of their satisfaction with the counselors at the completion of the prenatal and post-partum interventions .
RESULTS	Coding indicated counselor adherence to MI protocol and variation among counselors in the use of MI skills in the MI condition .
RESULTS	Almost no MI behaviors were found in the HE condition .
RESULTS	Differences in the length of time to deliver intervention were found ; as expected , the HE intervention took less time .
RESULTS	There were no differences between the overall participants ' satisfaction ratings of the HE and MI sessions by individual counselor or overall ( p > .05 ) .
CONCLUSIONS	Trial design , protocol specification , training , and continuous supervision led to a high degree of treatment fidelity for the counseling interventions in this randomized clinical trial and will increase confidence in the interpretation of the trial findings .

###25148838
OBJECTIVE	We investigated clinical characteristics and outcomes of patients with significant valvular disease ( SVD ) in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation ( ROCKET AF ) trial .
RESULTS	ROCKET AF excluded patients with mitral stenosis or artificial valve prostheses .
RESULTS	We used Cox regression to adjust comparisons for potential confounders .
RESULTS	Among 14 171 patients , 2003 ( 14.1 % ) had SVD ; they were older and had more comorbidities than patients without SVD .
RESULTS	The rate of stroke or systemic embolism with rivaroxaban vs. warfarin was consistent among patients with SVD [ 2.01 vs. 2.43 % ; hazard ratio ( HR ) 0.83 , 95 % confidence interval ( CI ) 0.55-1 .27 ] and without SVD ( 1.96 vs. 2.22 % ; HR 0.89 , 95 % CI 0.75-1 .07 ; interaction P = 0.76 ) .
RESULTS	However , rates of major and non-major clinically relevant bleeding with rivaroxaban vs. warfarin were higher in patients with SVD ( 19.8 % rivaroxaban vs. 16.8 % warfarin ; HR 1.25 , 95 % CI 1.05-1 .49 ) vs. those without ( 14.2 % rivaroxaban vs. 14.1 % warfarin ; HR 1.01 , 95 % CI 0.94-1 .10 ; interaction P = 0.034 ) , even when controlling for risk factors and potential confounders .
RESULTS	In intracranial haemorrhage , there was no interaction between patients with and without SVD where the overall rate was lower among those randomized to rivaroxaban .
CONCLUSIONS	Many patients with ` non-valvular atrial fibrillation ' have significant valve lesions .
CONCLUSIONS	Their risk of stroke is similar to that of patients without SVD after controlling for stroke risk factors .
CONCLUSIONS	Efficacy of rivaroxaban vs. warfarin was similar in patients with and without SVD ; however , the observed risk of bleeding was higher with rivaroxaban in patients with SVD but was the same among those without SVD .
CONCLUSIONS	Atrial fibrillation patients with and without SVD experience the same stroke-preventive benefit of oral anticoagulants .

###24237937
BACKGROUND	Burnout syndrome is an important health problem that affects many professionals and must be addressed globally , with both organizational measures and personal interventions .
BACKGROUND	Burnout of health professionals can be prevented in order to avoid personal , familial , and social consequences , as well as repercussions for patients .
METHODS	This work describes a protocol for a controlled , pragmatic , randomized clinical trial in 2 parallel groups : intervention and control .
METHODS	All health professionals from 7 health care centers will form the intervention group , and all health professionals from 7 different health care centers will form the control group .
METHODS	The intervention group will receive 16 hours of training at their work place .
METHODS	The Maslach 's burnout inventory , the Cuestionario de Desgaste Profesional Mdico or the Cuestionario de Desgaste Profesional de Enfermera , and the 28-item Goldberg 's General Health Questionnaire , validated for our setting , will be used as measurement tools .
METHODS	Change in the average scores from the Maslach 's burnout inventory emotional exhaustion scale will be compared between the intervention and control groups , measured as intention-to-treat , and the intervention will be considered effective if a minimum decrease of 20 % is achieved .
CONCLUSIONS	Due to the deleterious consequences of burnout syndrome for people suffering from it and for the organization where they work , it is necessary to evaluate the effectiveness of certain interventions for its prevention .
CONCLUSIONS	Organizational measures are important for preventing burnout syndrome , but so is providing professionals with coping strategies , as this group intervention intends to do .
BACKGROUND	ClinicalTrials.gov processed this record on June 10 , 2013 .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01870154 .

###24835860
OBJECTIVE	To evaluate whether administration of analgesic medication one hour before undergoing office hysteroscopy decreased pain and other side effects .
METHODS	A prospective randomized study was carried out in 200 patients who underwent office hysteroscopy from November 2011 until May 2012.100 patients received 1000mg paracetamol and 600mg ibuprofen one hour before the procedure and 100 did not receive any medication .
RESULTS	We observed significant differences ( p = 0.013 ) regarding the occurrence of non-pain side effects , 6 % in the non-medicated group and none of the patients in the medicated group .
RESULTS	The main pain score was always slightly higher in the group receiving no medication , though there was no statistically significant difference when compared to the medicated group .
CONCLUSIONS	Administration of 1g paracetamol and 600mg ibuprofen one hour prior to office hysteroscopy decreased statistically the occurrence of non-pain side effects such as nausea , emesis , and hypotension .
CONCLUSIONS	No differences in pain scores were observed .

###24926949
BACKGROUND	Vitamin D promotes bone health and regulates the immune system , both important actions for pediatric patients with inflammatory bowel disease ( IBD ) .
BACKGROUND	The supplementation dose that would maintain optimal serum 25-hydroxyvitamin D concentration ( 25OHD 32 ng/mL ) is unknown .
OBJECTIVE	The objective of the study was to compare two supplementation regimens ' efficacy and safety in maintaining optimal 25OHD in children with IBD .
METHODS	This was a randomized , not blinded , controlled trial .
METHODS	The trial was conducted in the Boston Children 's Hospital Clinical and Translational Study Unit .
METHODS	Sixty-three patients , aged 8-18 years with IBD and baseline 25OHD greater than 20 ng/mL were enrolled ; 48 completed the study , and one withdrew for adverse events .
METHODS	Arm A received 400 IU of oral vitamin D2 daily ( n = 32 ) .
METHODS	Arm B received 1000 IU daily in the summer/fall and 2000 IU in the winter/spring ( n = 31 ) .
RESULTS	The main outcome was the probability of maintaining 25OHD of 32 ng/mL or greater in all trimonthly visits for 12 months .
RESULTS	Three participants in arm A ( 9.4 % ) and three in arm B ( 9.7 % ) achieved the primary outcome ( P = .97 ) .
RESULTS	The incidence of adverse events , all minor , did not differ .
RESULTS	More participants in arm A developed C-reactive protein level of 1 mg/dL or greater ( 31 % vs 10 % , P = .04 ) and IL-6 greater than 3 pg/mL ( 54 % vs 27 % , P = .05 ) .
CONCLUSIONS	Daily oral vitamin D2 doses up to 2000 IU were inadequate to maintain optimal 25OHD but were well tolerated .
CONCLUSIONS	The finding of lower incidence of elevated inflammatory markers and cytokines among participants receiving higher vitamin D2 doses merits further study .

###24312178
BACKGROUND	In the clinic setting both fasting levels of glucose and the area under the curve ( AUC ) of glucose , by determination of HbA1c levels , are used for risk assessments , in type 2 diabetes ( NIDDM ) .
BACKGROUND	However little is known about postprandial levels , and hence AUC , regarding other traditional risk factors such as insulin and blood-lipids and how this is affected by different diets .
OBJECTIVE	To study postprandial effects of three diets , during a single day , in NIDDM .
METHODS	A low-fat diet ( 45-56 energy - % from carbohydrates ) , and a low-carbohydrate diet ( 16-24 energy - % from carbohydrates ) was compared with a Mediterranean-style diet ( black coffee for breakfast and the same total-caloric intake as the other two diets for lunch with red wine , 32-35 energy - % from carbohydrates ) in a randomized cross-over design .
METHODS	Total-caloric intake/test-day at the clinic from food was 1025-1080 kCal in men and 905-984 kCal in women .
METHODS	The test meals were consumed at a diabetes ward under supervision .
RESULTS	Twenty-one participants were recruited and 19 completed the studies .
RESULTS	The low-carbohydrate diet induced lower insulin and glucose excursions compared with the low-fat diet ( p < 0.0005 for both AUC ) .
RESULTS	The insulin-response following the single Mediterranean-style lunch-meal was more pronounced than during the low-fat diet lunch ( insulin increase-ratio of the low-fat diet : 4.35 2.2 , of Mediterranean-style diet : 8.12 5.2 , p = 0.001 ) while postprandial glucose levels were similar .
RESULTS	The increase-ratio of insulin correlated with the elevation of the incretin glucose-dependent insulinotropic-polypeptide following the Mediterranean-style diet lunch ( Spearman , r = 0.64 , p = 0.003 ) .
CONCLUSIONS	The large Mediterranean-style lunch-meal induced similar postprandial glucose-elevations as the low-fat meal despite almost double amount of calories due to a pronounced insulin-increase .
CONCLUSIONS	This suggests that accumulation of caloric intake from breakfast and lunch to a single large Mediterranean style lunch-meal in NIDDM might be advantageous from a metabolic perspective .
BACKGROUND	ClinicalTrials.gov NCT01522157 NCT01522157 .

###24993605
OBJECTIVE	In the Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure ( EMPHASIS-HF ) , aldosterone blockade with eplerenone decreased mortality and hospitalisation in patients with mild symptoms ( New York Heart Association class II ) and chronic systolic heart failure ( HF ) .
OBJECTIVE	The present study evaluated the cost-effectiveness of eplerenone in the treatment of these patients in the UK and Spain .
RESULTS	Results from the EMPHASIS-HF trial were used to develop a discrete-event simulation model estimating lifetime direct costs and effects ( life years and quality-adjusted life years ( QALYs ) gained ) of the addition of eplerenone to standard care among patients with chronic systolic HF and mild symptoms .
RESULTS	Eplerenone plus standard care compared with standard care alone increased lifetime direct costs per patient by 4284 for the UK and 7358 for Spain , with additional quality-adjusted life expectancy of 1.22 QALYs for the UK and 1.33 QALYs for Spain .
RESULTS	Mean lifetime costs were 3520 per QALY in the UK and 5532 per QALY in Spain .
RESULTS	Probabilistic sensitivity analysis suggested a 100 % likelihood of eplerenone being regarded as cost-effective at a willingness-to-pay threshold of 20000 per QALY ( UK ) or 30000 per QALY ( Spain ) .
CONCLUSIONS	By currently accepted standards of value for money , the addition of eplerenone to optimal medical therapy for patients with chronic systolic HF and mild symptoms is likely to be cost-effective .

###24912842
OBJECTIVE	To assess the impact of anemia and iron deficiency on health-related quality of life ( HRQoL ) in women treated for heavy menstrual bleeding ( HMB ) .
METHODS	Secondary analysis of a randomized controlled trial .
METHODS	Five university hospitals in Finland .
METHODS	A total of 236 women referred for HMB .
METHODS	Women were randomized to treatment with hysterectomy or a levonorgestrel-releasing intrauterine system .
METHODS	We defined groups based on women 's pretreatment hemoglobin [ hemoglobin < 120g/L ( anemic ) vs. hemoglobin 120g/L ( nonanemic ) ] and serum ferritin ( ferritin < 15g/L vs. 15g/L ) concentrations .
METHODS	HRQoL was compared between groups at baseline , 6 and 12months after treatment .
METHODS	Hemoglobin and ferritin were followed for 5years .
METHODS	HRQoL was measured by the RAND 36-item health survey ( RAND-36 ) , 5-Dimensional EuroQol and two questionnaires of mental wellbeing .
RESULTS	At baseline , 63 women ( 27 % ) were anemic and 140 ( 60 % ) were severely iron deficient ( ferritin < 15g/L ) .
RESULTS	Only 8 % of the anemic women had taken iron supplementation .
RESULTS	Twelve months after treatment hemoglobin had increased in both hemoglobin groups , but was still significantly lower ( p < 0.001 ) in initially anemic women ( 128g/L ) compared with nonanemic women ( 136g/L ) .
RESULTS	Twelve months after treatment three domain scores of RAND-36 increased more ( energy , p = 0.002 ; physical functioning , p = 0.04 ; social functioning , p = 0.05 ) , and anxiety ( p = 0.02 ) and depression scores ( p = 0.002 ) decreased more in anemic compared with nonanemic women .
RESULTS	Serum ferritin took 5years to reach normal levels .
CONCLUSIONS	Improved HRQoL after treatment of HMB is associated with correction of anemia .
CONCLUSIONS	Clinicians should actively screen for anemia in women with HMB and emphasize early iron substitution as an integral part of treatment .

###25524951
OBJECTIVE	People with diabetes frequently develop vascular disease .
OBJECTIVE	We investigated the relationship between blood 25-hydroxyvitamin D ( 25OH-D ) concentration and vascular disease risk in type 2 diabetes .
METHODS	The relationships between blood 25OH-D concentration at baseline and the incidence of macrovascular ( including myocardial infarction and stroke ) and microvascular ( retinopathy , nephropathy , neuropathy , and amputation ) disease were analyzed with Cox proportional hazards models and logistic regression in an observational study of patients in the 5-year Fenofibrate Intervention and Event Lowering in Diabetes trial .
RESULTS	A total of 50 % of the patients had low vitamin D concentrations , as indicated by median blood 25OH-D concentration of 49 nmol/L .
RESULTS	These patients with a blood 25OH-D concentration < 50 nmol/L had a higher cumulative incidence of macrovascular and microvascular events than those with levels 50 nmol/L .
RESULTS	Multivariate analysis , stratified by treatment and adjusted for relevant confounders , identified blood 25OH-D concentration as an independent predictor of macrovascular events .
RESULTS	A 50 nmol/L difference in blood 25OH-D concentration was associated with a 23 % ( P = 0.007 ) change in risk of macrovascular complications during the study , and further adjustments for seasonality , hs-CRP , and physical activity level had little impact .
RESULTS	The unadjusted risk of microvascular complications was 18 % ( P = 0.006 ) higher during the study , though the excess risk declined to 11-14 % and lost significance with adjustment for HbA1c , seasonality , or physical activity .
CONCLUSIONS	Low blood 25OH-D concentrations are associated with an increased risk of macrovascular and microvascular disease events in type 2 diabetes .
CONCLUSIONS	However , a causal link remains to be demonstrated .

###25867075
BACKGROUND	Asthma clinical guidelines suggest written asthma action plans are essential for improving self-management and outcomes .
OBJECTIVE	To assess the efficacy of written instructions in the form of a written asthma action plan provided by subspecialist physicians as part of usual asthma care during office visits .
METHODS	A total of 407 children and adults with persistent asthma receiving first-time care in pulmonary and allergy practices at 4 urban medical centers were randomized to receive either written instructions ( n = 204 ) or no written instructions other than prescriptions ( n = 203 ) from physicians .
RESULTS	Using written asthma action plan forms as a vehicle for providing self-management instructions did not have a significant effect on any of the primary outcomes : ( 1 ) asthma symptom frequency , ( 2 ) emergency visits , or ( 3 ) asthma quality of life from baseline to 12-month follow-up .
RESULTS	Both groups showed similar and significant reductions in asthma symptom frequency ( daytime symptoms [ P < 0.0001 ] , nocturnal symptoms [ P < 0.0001 ] , - agonist use [ P < 0.0001 ] ) .
RESULTS	There was also a significant reduction in emergency visits for the intervention ( P < 0.0001 ) and control ( P < 0.0006 ) groups .
RESULTS	There was significant improvement in asthma quality-of-life scores for adults ( P < 0.0001 ) and pediatric caregivers ( P < 0.0001 ) .
CONCLUSIONS	Our results suggest that using a written asthma action plan form as a vehicle for providing asthma management instructions to patients with persistent asthma who are receiving subspecialty care for the first time confers no added benefit beyond subspecialty-based medical care and education for asthma .
CONCLUSIONS	Clinical trial registered with www.clinicaltrials.gov ( NCT 00149461 ) .

###25135244
BACKGROUND	Gentamicin is used as a therapeutic agent for Mnire 's disease because of its vestibulotoxicity causing chemo-ablation of the vestibular sensory epithelia .
BACKGROUND	Its use has increased in recent years .
BACKGROUND	However , there is still no consensus about the dose regimen of gentamicin in the treatment of Mnire 's disease .
BACKGROUND	In this study two different dose regimen treatment protocols are compared in a placebo controlled study design .
BACKGROUND	The primary objective is to quantify the treatment effect on dizziness , the secondary objective is hearing evaluation .
METHODS	We performed a randomized , double-blind , placebo-controlled study in adults with unilateral Mnire 's disease according to the AAO-HNS guidelines resistant to conservative medication .
METHODS	Three groups received four injections , administered weekly ( four intratympanic injections with 40mg/mL gentamicin solution , two injections gentamicin solution and two injections of placebo in random order , or four injections with placebo ) .
METHODS	Outcome measures were the score on the Dizziness Handicap Inventory and pure tone audiometry ( PTA ) .
METHODS	Intended follow-up was 2years .
RESULTS	During follow-up one patient exceeded the accepted amount of hearing loss .
RESULTS	Further , enrollment was very slow ( until 12months between two patients ) and new insights showed an apparent benefit of intratympanic gentamicin treatment ( ITG ) .
RESULTS	Therefore we performed an unscheduled interim analysis which showed that PTA threshold shifts reached the stopping criteria in two more patients .
RESULTS	Because of this , this study was ended .
RESULTS	Of the three patients with the significant PTA threshold shift two were enrolled in the gentamicin group .
CONCLUSIONS	No conclusions can be drawn concerning doses regimens .
CONCLUSIONS	Now that new publications have shown that ITG treatment can be an effective and safe treatment , a placebo-controlled randomized controlled trial may not pass the ethical committee because of these recent reports in literature .
CONCLUSIONS	Still , a dose regimen study ( without placebo ) on ITG treatment needs to be performed .
BACKGROUND	This trial was registered in The University Medical Center Utrecht / Gelre hospital Apeldoorn .
BACKGROUND	Protocol ID : 07/343 , EudraCT number 2006-005913-37 .

###24666268
OBJECTIVE	The purpose of this study was to investigate whether the availability of both dextroamphetamine and methylphenidate provides an opportunity to minimize adverse events in a pediatric attention-deficit/hyperactivity disorder ( ADHD ) stimulant trial .
METHODS	Thirty-six medication-nave children 9-14 years of age , diagnosed with ADHD , were enrolled for 6 weeks in a crossover trial , with 2 weeks of methylphenidate , dextroamphetamine , and a placebo in a randomly assigned , counterbalanced sequence .
METHODS	Barkley 's Side-Effect Rating Scale ( SERS ) , rated by parents , was used to assess adverse events .
METHODS	SERS were available for 34 children , and data were analyzed both at the group and the single-subject level .
RESULTS	The side-effect profiles of dextroamphetamine and methylphenidate appeared similar at the group level .
RESULTS	Overall , insomnia and decreased appetite were the only adverse events associated with the stimulants as compared with placebo .
RESULTS	No significant increase from placebo to stimulant conditions was detected on SERS items reflecting emotional symptoms .
RESULTS	Furthermore , dextroamphetamine and methylphenidate did not differ from each other on any SERS item , except that dextroamphetamine was associated with higher severity of `` insomnia '' and a higher prevalence of `` unusually happy . ''
RESULTS	Single-subject analyses showed that one or more adverse events were reported in 14 children ( 41 % ) , and were evenly distributed between those with dextroamphetamine as the drug that showed the greatest reduction in their ADHD symptoms ( `` best drug '' ) and those with methylphenidate as their best drug .
RESULTS	Among children in whom both stimulants were associated with a decrease in ADHD symptoms , a clinically valid difference between the two stimulants in total adverse events score was found in 7 ( 39 % ) of the 18 cases .
RESULTS	In these children , the availability of both stimulants provided an opportunity to minimize adverse events , while maintaining a reduction in ADHD symptoms .
CONCLUSIONS	The availability of both dextroamphetamine and methylphenidate may contribute to minimize adverse events in a subsample of children in pediatric ADHD stimulant trials .
BACKGROUND	The study was first registered in clinical trials September 28 , 2010 .
BACKGROUND	Clinical Trials.gov Identifier : NCT01220440 .

###25108448
BACKGROUND	Optimal starting point for antiretroviral treatment ( ART ) has been uncertain .
METHODS	Parallel group , single blind , randomised controlled study of adult HIV positive patients consulting at the Protestant Hospital , Ngaoundere , Cameroon in 2007-8 .
METHODS	Simple randomisation of patients in WHO clinical stage 1-2 to start of ART early or deferred , i.e. when CD4 counts dropped below 350 versus 250 cells/mm ( 3 ) , or when they reached clinical stage 3-4 .
METHODS	Clinical follow-up every three months were offered for all patients .
METHODS	Main outcomes were clinical stage , CD4 differences and mortality .
METHODS	Of 424 consulting patients , most were excluded , mainly because they were already in WHO stage 3-4 .
METHODS	Forty-four patients were randomised .
RESULTS	In the ` early ' group two patients died and five were lost to follow-up .
RESULTS	In the ` deferred ' group , six patients died and nine were lost to follow-up ( Hazard ratio for death by early compared to deferred treatment 0.26 , 95 % confidence interval 0.05-1 .29 ) .
RESULTS	Of the patients lost to follow-up , three patients in the ` early ' group and four patients in the ` deferred ' group were known to be alive when the study ended .
RESULTS	Fourteen patients in the early group and 11 in the deferred group started ART .
RESULTS	Twenty-two patients were evaluated clinically six to seven months after the study period was terminated .
RESULTS	Except for one patient with AIDS , these were all still in clinical stage 1-2 .
CONCLUSIONS	In our small sample , relative risk for death did not differ significantly , but deferred treatment seemed to carry no increased survival or other clinical advantage .
CONCLUSIONS	During the study period , other studies made WHO change its guidelines to conform to our early treatment .
CONCLUSIONS	The tendency in our study lends support to this policy .
BACKGROUND	ISRCTN22114173 .

###24562444
OBJECTIVE	To determine whether tumor grade , molecular subtype and hypoxia predict response to hypofractionated versus standard radiotherapy ( RT ) following breast-conserving surgery ( BCS ) for node-negative breast cancer in a randomized controlled trial ( RCT ) .
METHODS	Formalin-fixed paraffin-embedded ( FFPE ) tumor blocks were available on 989 of 1234 patients enrolled in the Hypofractionation Whole Breast Irradiation ( HWBI ) Trial .
METHODS	A central pathology review and assessment of tumor grade using the Nottingham grading system was carried out .
METHODS	Tumors were classified by molecular subtype as luminal A , luminal B , HER2 enriched , basal-like or unclassified using a six-biomarker panel ; ER , PR , HER-2 , Ki67 , CK5/6 and EGFR .
METHODS	Tumors were also classified as hypoxic based on the expression of HIF1 , CAIX or GLUT-1 .
METHODS	The primary end point was local recurrence ( LR ) .
RESULTS	Median follow-up was 12 years .
RESULTS	In the multivariable Cox model , molecular subtype was the only factor predictive of LR , the 10-year cumulative incidence was 4.5 % for luminal A and basal-like , 7.9 % for luminal B and 16.9 % for HER-2 enriched tumors ( P < 0.01 ) .
RESULTS	Tumor grade , molecular subtype or hypoxia did not predict response to hypofractionation .
CONCLUSIONS	In women enrolled in the HWBI trial following BCS tumor molecular subtype predicted LR .
CONCLUSIONS	However tumor grade , molecular subtype and hypoxia did not predict response to hypofractionation suggesting that patients with node-negative breast tumors of all grades and molecular subtypes may be safely treated with hypofractionated RT regimens .

###24618266
OBJECTIVE	To compare the efficacy of etanercept ( ETN ) and methotrexate ( MTX ) versus MTX monotherapy for remission induction in patients with early inflammatory arthritis .
METHODS	In a 78-week multicentre randomised placebo-controlled superiority trial , 110 DMARD-nave patients with early clinical synovitis ( 1 tender and swollen joint , and within 3 months of diagnosis ) and either rheumatoid factor , anticitrullinated protein antibodies or shared epitope positive were randomised 1:1 to receive MTX+ETN or MTX + placebo ( PBO ) for 52 weeks .
METHODS	Injections ( ETN or PBO ) were stopped in all patients at week 52 .
METHODS	In those with no tender or swollen joints ( NTSJ ) for > 26 weeks , injections were stopped early .
METHODS	If patients had NTSJ > 12 weeks after stopping the injections , MTX was weaned .
METHODS	The primary endpoint was NTSJ at week 52 .
RESULTS	No statistically significant difference was seen for the primary endpoint ( NTSJ at week 52 ( 32.5 % vs 28.1 % [ adjusted OR 1.32 ( 0.56 to 3.09 ) , p = 0.522 ] ) in the MTX+ETN and MTX+PBO groups , respectively ) .
RESULTS	The secondary endpoints did not differ between groups at week 52 or 78 .
RESULTS	Exploratory analyses showed a higher proportions of patients with DAS28-CRP < 2.6 in the MTX+ETN group at week 2 ( 38.5 % vs 9.2 % , adjusted OR 8.87 ( 2.53 to 31.17 ) , p = 0.001 ) and week 12 ( 65.1 % vs 43.8 % , adjusted OR 2.49 ( 1.12 to 5.54 ) , p = 0.026 ) .
CONCLUSIONS	In this group of patients with early inflammatory arthritis , almost a third had no tender , swollen joints after 1 year .
CONCLUSIONS	MTX+ETN was not superior to MTX monotherapy in achieving this outcome .
CONCLUSIONS	Clinical responses , however , including DAS28-CRP < 2.6 , were achieved earlier with MTX+ETN combination therapy .
BACKGROUND	The EMPIRE trial is registered on the following trial registries : Eudract-2005-005467-29 ; ISRCTN 55428162 ( http://www.controlled-trials.com/ISRCTN55428162/EMPIRE ) .
BACKGROUND	The full trial protocol can be obtained from the corresponding author .

###25097285
OBJECTIVE	Selective serotonin reuptake inhibitors ( SSRI ) and serotonin-norepinephrine reuptake inhibitors ( SNRI ) are effective in treating anxiety disorders associated with major depressive disorder ( MDD ) .
OBJECTIVE	This randomized , controlled , parallel-group , open-label , phase 4 trial ( CTRI/2012/08 / 002895 ) was undertaken to compare the effectiveness and safety of desvenlafaxine versus escitalopram , a standard antidepressant .
METHODS	Effectiveness was assessed using the Hamilton Depression Rating Scale ( HAM-D17 ) and Hamilton Anxiety Rating Scale ( HAM-A ) .
METHODS	Response to treatment was assessed by 50 % decrease of baseline scores ( responder rate ) .
METHODS	Safety and tolerability was evaluated by changes in routine laboratory parameters , vital signs , and adverse events reported by the subject and/or observed by the clinician .
RESULTS	Responder rates for both HAM-A and HAM-D scores at 8 weeks were better in the escitalopram group compared to the desvenlafaxine group ( HAM-A 76.92 % vs. 71.05 % ; HAM-D 79.48 % vs 73.68 % ) but the differences were not statistically significant ( P = 0.59 and P = 0.61 ) .
RESULTS	Within group changes of both scores , from baseline to subsequent visits in both treatment arms were statistically significant ( P < 0.01 ) .
CONCLUSIONS	The effectiveness of desvenlafaxine was comparable to escitalopram , but escitalopram was better tolerated .

###26101115
OBJECTIVE	To examine if a small token monetary incentive ( NZ$ 5 ) increases mail survey response rates and participant retention of 40-50 year old New Zealand women .
METHODS	In 2009 , 2500 women were randomly selected from the New Zealand electoral rolls for a prospective study investigating factors related to the prevention of weight gain .
METHODS	At baseline , 400 women were randomly assigned to receive NZ$ 5 with the initial survey mail-out in addition to nonmonetary gifts to encourage participation ( pen , tea bag , entry in lottery draw ) received by all women .
METHODS	At 2 years , 400 women ( 200 received NZ$ 5 at baseline and 200 had not ) were randomly assigned to receive the same token monetary incentive .
METHODS	At 3 years , all women identifying as an ethnic minority ( n = 234 ) and 300 randomly selected women of other ethnicities received the token monetary incentive with the initial mail out .
RESULTS	The baseline response rate for women who received NZ$ 5 was significantly higher than for women who did not ( 76 % vs 64 % , p < 0.001 ) .
RESULTS	At 2 years , retention rate for all women who received NZ$ 5 was significantly higher than for women who did not ( 88 % vs 80 % , p < 0.001 ) .
RESULTS	At 3 years , among those women not identifying as an ethnic minority , the retention rate for those who received NZ$ 5 was significantly higher than for those who did not ( 84 % vs 77 % , p = 0.014 ) .
CONCLUSIONS	Inclusion of a small token monetary incentive significantly increases mail survey response rates and participant retention in mid-age New Zealand women .

###24351699
OBJECTIVE	Co-sleeping is associated with disturbance of the natural sleep pattern , including sleep fragmentation and daytime sleepiness .
OBJECTIVE	Nocturnal enuresis ( NE ) or bed-wetting , although benign , is a significant cause of distress to affected children and their caregiver ( s ) .
OBJECTIVE	This study investigated the relationship between co-sleeping and NE in primary school children from China .
METHODS	Data from a previous sleep study of primary school children from 8 cities across China were analyzed .
METHODS	Multivariable regression analysis was performed to assess the relationship between co-sleeping and NE while controlling for a number of confounding factors .
METHODS	The prevalence of NE in co-sleeping and non-co-sleeping children in different age groups was evaluated .
RESULTS	The prevalence of co-sleeping and NE in children aged 5 to 12 years was 22.8 % and 4.6 % , respectively .
RESULTS	Co-sleeping was associated with a higher prevalence of NE in primary school age children ( odds ratio [ OR ] , 1.50 ; 95 % confidence interval [ CI ] , 1.27-1 .77 ; p < .001 ) after adjusting for confounding factors .
RESULTS	The differences in the prevalence of NE between co-sleepers and non-co-sleepers were significant in the 9-year age group ( OR , 1.49 ; 95 % CI , 1.06-2 .11 ; p = .025 ) and 11 - to 12-year age group ( OR , 3.16 ; 95 % CI , 2.19-4 .57 ; p < .001 ) .
CONCLUSIONS	Co-sleeping may increase the risk of NE in primary school children , particularly in those aged 11 to 12 years .

###24227806
OBJECTIVE	To investigate the effect of nicotine on choroidal thickness using optical coherence tomography ( OCT ) .
METHODS	Prospective , case-control study .
METHODS	Sixteen young , healthy subjects and 16 age and gender matched control cases were included in this study ; 4 mg nicotine gum was given to the study group and placebo gum to the control group .
METHODS	All participants underwent OCT scanning with a high-speed and resolution spectral-domain OCT device ( 3D OCT 2000 , Topcon , Japan ) at baseline , and 1 h following nicotine or placebo administration .
METHODS	The measurements were taken in the morning ( 10:00 -12:00 hours ) to avoid diurnal fluctuation .
RESULTS	The median foveal choroidal thickness at baseline was 337.00 m ( IQR 84.50 ) , which decreased to 311.00 m ( IQR 78.00 ) at 1 h following oral nicotine intake ( p = 0.001 ) .
RESULTS	The median choroidal thickness was also significantly decreased at five other extrafoveal points ( p < 0.05 for all ) .
RESULTS	In the control group , the median baseline choroidal thickness at the fovea was 330.50 m ( IQR 104.25 ) , and was 332.00 m ( IQR 103.75 ) at 1 h ( p = 0.271 ) .
CONCLUSIONS	Nicotine causes a significant decrease in choroidal thickness following oral intake .
CONCLUSIONS	This acute decrease might be a result of reduced ocular blood flow due to the vasoconstrictive effect of nicotine .

###24520915
OBJECTIVE	To describe successful methods of recruitment and identify practice characteristics related to increased recruitment of older people for a randomised controlled trial .
METHODS	General practices in three regions of New Zealand and community-dwelling patients aged 75 + were recruited for the Brief Risk Identification Geriatric Health Tool trial .
METHODS	General practitioners ( GPs ) were faxed invitations with telephone follow-up .
METHODS	Reply-paid cards with telephone follow-up were used to invite older people .
METHODS	GP and practice characteristics were examined in relationship to recruitment rate .
RESULTS	During 2007-2008 , 158 of 438 GPs ( 36 % ) in 60 of 116 practices approached ( 52 % ) were recruited .
RESULTS	Regional variation was marked and 3893 of 8308 invited ( 49 % ) older people were recruited .
RESULTS	The GP 's length of time at the practice and training in New Zealand was associated with recruitment success .
CONCLUSIONS	Despite variability in practice recruitment , a reasonably large and representative sample of older people was recruited through general practices .

###26434090
BACKGROUND	Complaints of knee pain secondary to early osteoarthritis may account for up to 30 % of visits to primary care physicians .
BACKGROUND	Due to the proposed inflammatory changes in early osteoarthritis , intra-articular injections of corticosteroids ( IACS ) have been considered as an option for disease progression modification , pain control , and improvement of function .
BACKGROUND	However , some studies have suggested poor accuracy rates of IA injections depending on the entry site chosen .
BACKGROUND	It is therefore the aim of this study to evaluate the efficacy of IA knee corticosteroid injection in reducing pain and improving function in patients with early osteoarthritis and whether the low accuracy rates reported with the Anterolateral joint line injection site translate to worse functional and pain outcome measures as compared to Suprapatellar lateral injections .
METHODS	The study was carried out as an open-label , randomized controlled trial with 60 sequential patients recruited .
METHODS	Simple randomization separated groups into anterolateral joint line or suprapatellar lateral injection sites .
METHODS	Improvements were measured with WOMAC and VAS scores after injection of Lidocaine and steroid solution .
RESULTS	Patients receiving IACS injections had a measurable improvement in self-reported outcomes as evidenced by standard deviation change in WOMAC and VAS scores .
RESULTS	The majority of patients had a clinically significant improvement in VAS scores as compared to their initial measures with a notable amount of patients improving significantly as well on their WOMAC scores , irrespective of the injection site chosen .
CONCLUSIONS	We have therefore continued the use of palpation-guided intra-articular knee injections in an effort to reduce costs as compared to other injection modalities with positive results in our osteoarthritis patients .

###25911899
OBJECTIVE	Artificial ulcers remain a major complication after Endoscopic submucosal dissection ( ESD ) .
OBJECTIVE	The development of more effective treatment regimen for this ulcer is required than the use of proton pump inhibitor ( PPI ) alone .
METHODS	Patients with ESD-derived artificial ulcers were randomly assigned to two groups : a group of patients who received rabeprazole 20 mg daily for 8 weeks ( PPI group ) and a group of patients who received a combination of rebamipide 300 mg daily for 8 weeks and rabeprazole 20 mg dairy for the first 4 weeks ( reb + PPI group ) .
METHODS	The area reduction ratio and healing status of ulcers were evaluated endoscopically on postoperative 7 , 28 and 56 days .
RESULTS	The overall ulcer area reduction ratio was higher in the reb + PPI group than in the PPI group , especially at an early stage .
RESULTS	The ratio of progression to the H1 stage in the reb + PPI group was significantly higher than that in the PPI group , especially at an early stage .
CONCLUSIONS	Treatment with 8 weeks of rebamipide plus the first 4 weeks of PPI demonstrated a reduction ratio of artificial ulcers superior to that with 8 weeks of PPI mono-therapy .
CONCLUSIONS	This combination treatment is , therefore , one of the candidate treatment strategies against ESD-derived artificial ulcers .

###24280467
OBJECTIVE	To evaluate the effectiveness of magnetotherapy in the treatment of hand osteoarthritis ( HO ) .
METHODS	In this randomized controlled single-blind follow-up study , patients with HO were randomly assigned into 2 groups ( G1 and G2 ) .
METHODS	The subjects in G1 ( n = 25 ) received 25Hz , 450 pulse/s , 5-80G , magnetotherapy of totally 10 days and 20 min/day combined with active range of motion/strengthening exercises for the hand .
METHODS	G2 ( n = 25 ) received sham-magnetotherapy for 20 min/day for the same duration combined with the same hand exercises .
METHODS	Outcome measures were pain and joint stiffness evaluation , handgrip and pinchgrip strength ( HPS ) , Duruz and Auscan Hand Osteoarthritis Indexes ( DAOI ) and Short Form-36 Health Questionnaire ( SF-36 ) administered at baseline , immediately after treatment and at the follow up .
RESULTS	When the groups were compared with each other , improvement observed in SF-36 Pain ( p < 0.001 ) , SF-36 Social Function ( p = 0.030 ) , SF-36 Vitality ( p = 0.002 ) , SF-36 General Health ( p = 0.001 ) , Pain at rest ( p < 0.001 ) , Pain at motion ( p < 0.001 ) , Joint stiffness ( p < 0.001 ) , DAOI ( p < 0.001 ) were in favor of G1 .
CONCLUSIONS	Changes in pain , function and quality of life scores showed significant advantage in favor of the applied electromagnetic intervention in patients with HO .

###25609939
OBJECTIVE	To determine the frequency of pharmacogenomic variants and concurrent medications that may alter the efficacy and tolerability of acetylcholinesterase inhibitors ( AChEIs ) .
METHODS	A multisite cross-sectional study was carried out across four memory care practices in the greater Indianapolis area .
METHODS	Participants were adults aged 65 years and older with a diagnosis of probable or possible Alzheimer 's disease ( AD ) ( n = 105 ) .
METHODS	Blood samples and self-reported medication data were collected .
METHODS	Since two of the three AChEIs are metabolized by cytochrome P450 ( CYP ) -2 D6 , we determined the frequency of functional genetic variants in the CYP2D6 gene and calculated their predicted CYP2D6-activity scores .
METHODS	Concurrent medication data were collected from self-reported medication surveys , and their predicted effect on the pharmacokinetics of AChEIs was determined based on their known effects on CYP2D6 and CYP3A4/5 enzyme activities .
RESULTS	Among the 105 subjects enrolled , 72 % were female and 36 % were African American .
RESULTS	Subjects had a mean age of 79.6 years .
RESULTS	The population used a mean of eight medications per day ( prescription and nonprescription ) .
RESULTS	The CYP2D6 activity score frequencies were 0 ( 3.8 % ) , 0.5 ( 4.8 % ) , 1.0 ( 36.2 % ) , 1.5-2 .0 ( 51.4 % ) , and > 2.0 ( 3.8 % ) .
RESULTS	Nineteen subjects ( 18.1 % ) used a medication considered a strong or moderate inhibitor of CYP2D6 , and eight subjects ( 7.6 % ) used a medication considered a strong or moderate inhibitor of CYP3A4/5 .
RESULTS	In total , 28.6 % of the study population was predicted to have reduced activity of the CYP2D6 or CYP3A4/5 enzymes due to either genetic variants or concomitant medications .
CONCLUSIONS	Both pharmacogenetic variants and concurrent drug therapies that are predicted to alter the pharmacokinetics of AChEIs should be evaluated in older adults with AD .
CONCLUSIONS	Pharmacogenetic and drug-interaction data may help personalize AD therapy and increase adherence by improving tolerability .

###24565236
OBJECTIVE	In this study , our goal was to compare intraoperative and postoperative analgesic effects of lornoxicam and fentanyl when added to lidocaine Intravenous Regional Anesthesia ( IVRA ) in a group of outpatients who underwent hand surgery .
METHODS	This is a double blind randomized study .
METHODS	A total of 45 patients were included , randomized into three groups .
METHODS	Patients in Group I ( L ) received 3mg .
METHODS	kg ( -1 ) of 2 % lidocaine 40 mL ; patients in Group II ( LL ) received 3mg .
METHODS	kg ( -1 ) lidocaine 38 mL + 2 mL lornoxicam ; patients in Group III ( LF ) received 3mg .
METHODS	kg ( -1 ) lidocaine 38 mL + 2 mL fentanyl .
METHODS	Our primary outcome was first analgesic requirement time at postoperative period .
RESULTS	Lornoxicam added to lidocaine IVRA increased the sensory block recovery time without increasing side effects and increased first analgesic requirement time at the postoperative period when compared to lidocaine IVRA ( p < 0.001 , p < 0.001 respectively ) and fentanyl added to lidocaine IVRA ( p < 0.001 , p < 0.001 respectively ) .
RESULTS	In addition , we also found that fentanyl decreased tourniquet pain ( p < 0.01 ) when compared to lidocaine but showed similar analgesic effect with lornoxicam ( p > 0.05 ) although VAS scores related to tourniquet pain were lower in fentanyl group .
RESULTS	Lornoxicam added to lidocaine IVRA was not superior to lidocaine IVRA in decreasing tourniquet pain .
CONCLUSIONS	Addition of fentanyl to lidocaine IVRA seems to be superior to lidocaine IVRA and lornoxicam added to lidocaine IVRA groups in decreasing tourniquet pain at the expense of increasing side effects .
CONCLUSIONS	However , lornoxicam did not increase side effects while providing intraoperative and postoperative analgesia .
CONCLUSIONS	Therefore , lornoxicam could be more appropriate for clinical use .

###24314204
BACKGROUND	Employing waiting list control designs in psychological and behavioral intervention research may artificially inflate intervention effect estimates .
BACKGROUND	This exploratory randomized controlled trial tested this proposition in a study employing a brief intervention for problem drinkers , one domain of research in which waiting list control designs are used .
METHODS	All participants ( N = 185 ) were provided with brief personalized feedback intervention materials after being randomly allocated either to be told that they were in the intervention condition and that this was the intervention or to be told that they were in the waiting list control condition and that they would receive access to the intervention in four weeks with this information provided in the meantime .
RESULTS	A total of 157 participants ( 85 % ) were followed-up after 4weeks .
RESULTS	Between-group differences were found in one of four outcomes ( proportion within safe drinking guidelines ) .
RESULTS	An interaction was identified between experimental manipulation and stage of change at study entry such that participant change was arrested among those more ready to change and told they were on the waiting list .
CONCLUSIONS	Trials with waiting list control conditions may overestimate treatment effects , though the extent of any such bias appears likely to vary between study populations .
CONCLUSIONS	Arguably they should only be used where this threat to valid inference has been carefully assessed .

###25693609
BACKGROUND	A substantial proportion of patients with gastro-oesophageal reflux disease ( GERD ) have only a partial response to proton pump inhibitor ( PPI ) therapy .
BACKGROUND	Prokinetic drugs may improve reflux symptoms by enhancing oesophageal motility and gastric emptying .
OBJECTIVE	To evaluate the effect of revexepride , a novel prokinetic 5-hydroxytryptamine type 4 ( 5-HT4 ) receptor agonist , compared with placebo , in patients with GERD who have a partial response to PPIs .
METHODS	A phase 2b , double-blind , parallel-group study was conducted , in which patients were randomised to one of three revexepride treatment groups ( 0.1 , 0.5 and 2.0 mg three times daily ) or placebo ( 1:1:1:1 ratio ) .
METHODS	Daily e-diary data captured patients ' symptoms over an 8-week treatment period .
METHODS	The primary efficacy outcome was the weekly percentage of regurgitation-free days in the second half of the study ( weeks 5-8 ) .
RESULTS	In total , 480 patients were randomised and 477 received treatment ( mean age 47.9 years ; 61 % women ) .
RESULTS	The mean percentage of regurgitation-free days increased from baseline ( range , 15.0-18 .8 % ) to week 8 ( 62.3-70 .5 % ) in all four study arms ; however , there were no statistically significant differences in this change between placebo and the three treatment arms .
RESULTS	No dose-dependent relationship in treatment effect was observed for any of the study endpoints .
RESULTS	The incidence of treatment-emergent adverse events ( TEAEs ) was revexepride dose-dependent .
RESULTS	Only one serious TEAE occurred and none resulted in death .
CONCLUSIONS	Revexepride was no more effective than placebo in controlling regurgitation in patients with GERD symptoms partially responsive to PPIs .
CONCLUSIONS	Revexepride was well tolerated .
CONCLUSIONS	ClinicalTrials.gov Identifier : NCT01472939 .

###24710994
BACKGROUND	Despite improvements in the diagnosis and treatment of depression , primary care provider ( PCP ) discussion regarding suicidal thoughts among patients with depressive symptoms remains low .
OBJECTIVE	To determine whether a targeted depression public service announcement ( PSA ) video or an individually tailored interactive multimedia computer program ( IMCP ) leads to increased primary care provider ( PCP ) discussion of suicidal thoughts in patients with elevated risk for clinical depression when compared to an attention control .
METHODS	Randomized control trial at five different healthcare systems in Northern California ; two academic , two Veterans Affairs ( VA ) , and one group-model health maintenance organization ( HMO ) .
METHODS	Eight-hundred sixty-seven participants , with mean age 51.7 ; 43.9 % women , 43.4 % from a racial/ethnic minority group .
METHODS	The PSA was targeted to gender and socio-economic status , and designed to encourage patients to seek depression care or request information regarding depression .
METHODS	The IMCP was an individually tailored interactive health message designed to activate patients to discuss possible depressive symptoms .
METHODS	The attention control was a sleep hygiene video .
METHODS	Clinician reported discussion of suicidal thoughts .
METHODS	Analyses were stratified by depressive symptom level ( Patient Health Questionnaire [ PHQ-9 ] score < 9 [ mild or lower ] versus 10 [ at least moderate ] ) .
RESULTS	Among patients with a PHQ-9 score 10 , PCP discussion of suicidal thoughts was significantly higher in the IMCP group than in the control group ( adjusted odds ratio = 2.33 , 95 % confidence interval = 1.5 , 5.10 , p = 0.03 ) .
RESULTS	There were no significant effects of either intervention on PCP discussion of suicidal thoughts among patients with a PHQ-9 score < 9 .
CONCLUSIONS	Exposure of patients with at least moderate depressive symptoms to an individually tailored intervention designed to increase patient engagement in depression care led to increased PCP discussion of suicidal thoughts .

###24585907
BACKGROUND	Division of the parenchymal lung for lobectomy is performed in patients who have an incomplete fissure .
BACKGROUND	A stapler device can reduce postoperative air leak , but it is expensive .
OBJECTIVE	to investigate the advantage of using a stapler , in terms of postoperative air leak and cost , compared to hand-sewn techniques .
METHODS	A Non-blinded randomized controlled trial was conducted in Chiang Mai University Hospital , Thailand , from November 15 , 2011 to September 30 , 2012 .
METHODS	Fifty-three adult patients were randomized to undergo a hand-sewn technique ( 27 patients ) or stapler closure ( 26 patients ) .
RESULTS	Postoperative air leak in the stapler group was less than that in the hand-sewn group ( 7.7 % vs. 29.6 % , p = 0.044 ) , and the duration of air leak in the stapler group was significantly shorter than that in the hand-sewn group ( 1.0 vs. 13.4 days , p = 0.032 ) .
RESULTS	The cost of treatment was not significantly different between groups ; however , the total cost in the stapler group was less than that in the hand-sewn group ( mean difference 4454 Thai baht ( US$ 144.75 ) .
CONCLUSIONS	A stapler reduces postoperative air leaks and the duration of air leaks .
CONCLUSIONS	Furthermore , the total cost of treatment was comparable .
CONCLUSIONS	Therefore , using staples may provide substantial financial benefits .

###24780066
BACKGROUND	During perioperative fasting , lipid metabolism gradually increases , resulting in free fatty acids ( FFA ) and/or ketone bodies .
BACKGROUND	Suppression of surgical stress by remifentanil may allow the safe administration of glucose infusions , avoiding both hyperglycemia and ketogenesis .
BACKGROUND	The effects of glucose infusion on glucose and lipid metabolism were therefore investigated in patients undergoing minor surgery with remifentanil anesthesia .
METHODS	Thirty-four patients were randomized 1:1 to receive no glucose ( 0G group ) or low-dose glucose ( 0.1 g/kg/h for 1h followed by 0.05 g/kg/h for 1h ; LG group ) .
METHODS	The concentrations of glucose , adrenocorticotropic hormone ( ACTH ) , 3-methylhistidine ( 3-MH ) , insulin , cortisol , FFA , creatinine ( Cr ) , and ketone bodies were measured before anesthetic induction , 1 and 2h after glucose infusion , at the end of surgery , and the next morning .
RESULTS	The concentrations of cortisol and ACTH decreased during surgery in both groups when compared with the concentrations before anesthesia and at the end of surgery ( P < 0.05 ) .
RESULTS	Glucose and insulin concentrations were significantly higher in the LG than in the 0G group at 1 and 2h after infusion .
RESULTS	No patient experienced hyperglycemia .
RESULTS	The concentrations of FFA and ketone bodies were lower in the LG than in the 0G group during surgery , but there were no significant between group differences in 3-MH/Cr .
CONCLUSIONS	Infusion of low-dose glucose attenuated fat catabolism without causing hyperglycemia , indicating that infusion of low-dose glucose during remifentanil-induced anesthesia may be safe for patients .

###25137843
OBJECTIVE	To explore the clinical roles of Jiawei Shentong Zhuyu Decoction ( JSZD ) in preventing the occurrence of failed back surgery syndrome ( FBSS ) , and to observe its effect on serum tumor necrosis factor-alpha ( TNF-alpha ) .
METHODS	Totally 100 patients prepared for surgical operation due to lumbar intervertebral disc herniation were randomly assigned to the treatment group and the control group according to random number table , 50 cases in each group .
METHODS	Patients in the treatment group additionally took JSZD , one dose per day , taken in two portions , once in the morning and once in the evening .
METHODS	Those in the control group took Celecoxib Capsule ( 200 mg each time , once per day ) and Mecobalamin Tablet ( 0.5 mg each time , 3 times per day ) .
METHODS	They only took Mecobalamin Tablet from the 11th day .
METHODS	All patients were treated for 30 days .
METHODS	Japanese Orthopaedic Association ( JOA ) score was performed before treatment , at week 1 , after treatment , at 6 months of followed-ups , and at 12 months of followed-ups .
METHODS	And the levels of TNF-alpha in the peripheral blood were observed before treatment and at one month after treatment .
RESULTS	Totally 93 patients completed the followed-up study .
RESULTS	The JOA scores were improved after treatment , at 6 and 12 months of followed-ups ( P < 0.05 , P < 0.01 ) .
RESULTS	The JOA score at 6 months of followed-ups was superior in the treatment group to that of the control group ( P < 0.05 ) .
RESULTS	Five patients ( accounting for 10.6 % ) suffered from FBSS in the treatment group , while 9 ( accounting for 19.6 % ) suffered from FBSS in the control group .
RESULTS	The treatment group was superior to the control group ( P < 0.05 ) .
RESULTS	The TNFalpha level was improved after treatment in the two groups .
RESULTS	Of them , the improvement of TNF-alpha in the treatment group was better than that of the control group ( P < 0.05 ) .
CONCLUSIONS	The application of JSZD was effective for preventing the occurrence of FBSS , and improved the serum TNF-alpha level .

###24347384
BACKGROUND	The current study was conducted to investigate the dependence between progression-free survival ( PFS ) and overall survival ( OS ) in patients with metastatic renal cell carcinoma ( mRCC ) and to explore whether PFS can be used as an intermediate endpoint of OS in this patient population .
METHODS	A total of 1381 patients from 2 prospective phase 3 trials ( Cancer and Leukemia Group B [ CALGB ] 90206 and AVOREN ) of interferon-alpha with or without bevacizumab were analyzed .
METHODS	Both trials recruited previously untreated patients with clear cell mRCC with an Eastern Cooperative Oncology Group performance status of 0 to 2 ; adequate bone marrow , hepatic , cardiac , and renal function ; and controlled blood pressure .
METHODS	The CALGB study served as the training data set , and the AVOREN study served as the testing data set .
METHODS	The dependence between PFS and OS was investigated using the Kendall tau for bivariate time-to-event endpoints .
RESULTS	In the training data set , the median OS times among patients who experienced progressive disease at 3 months or 6 months were 6 months and 8 months , respectively , compared with 25 months and 30 months , respectively , ( P < .001 ) in patients who did not develop disease progress .
RESULTS	The adjusted hazard ratios ( HR ) were 2.6 ( P < .0001 ) and 2.8 ( P < .0001 ) , respectively , for patients who did and did not progress at 3 months or 6 months .
RESULTS	The dependence between PFS and OS was 0.53 .
RESULTS	These associations were confirmed in the testing data set .
CONCLUSIONS	In patients with mRCC who were treated with interferon-alpha with or without bevacizumab , the PFS at 3 months and 6 months was found to be predictive of OS .
CONCLUSIONS	A high dependence between PFS and OS was observed , suggesting that PFS may be used as a surrogate endpoint for OS .
CONCLUSIONS	Although this is a novel observation for RCC , these findings require validation in patients with mRCC who are treated with other targeted agents .

###25413377
OBJECTIVE	Clinical application of an antibiotic 's pharmacokinetic/pharmacodynamic ( PK/PD ) properties may improve the outcome of severe infections .
OBJECTIVE	No data are available on the use of linezolid ( LNZ ) continuous infusion in critically ill obese patients affected by ventilator-associated pneumonia ( VAP ) .
METHODS	We conducted a prospective randomized controlled trial to compare LNZ concentrations in plasma and epithelial lining fluid ( ELF ) , when administered by intermittent and continuous infusion ( II , CI ) , in obese critically ill patients affected by VAP .
RESULTS	Twenty-two critically ill obese patients were enrolled .
RESULTS	At the steady state , in the II group , mean SD total and unbound maximum-minimum concentrations ( C max/C max , u - C min/Cmin , u ) were 10 3.7 / 6.8 2.6 mg/L and 1.7 1.1 / 1.2 0.8 mg/L , respectively .
RESULTS	In the CI group , the mean SD total and unbound plasma concentrations ( C ss and C ss , u ) were 6.2 2.3 and 4.3 1.6 mg/L , respectively .
RESULTS	Within a minimum inhibitory concentration ( MIC ) range of 1-4 mg/L , the median ( IQR ) time LNZ plasma concentration persisted above MIC ( % T > MIC ) was significantly higher in the CI than the II group [ 100 ( 100-100 ) vs 100 ( 89-100 ) , p = 0.05 ; 100 ( 100-100 ) vs 82 ( 54.8-98 .8 ) , p = 0.009 ; 100 ( 74.2-100 ) vs 33 ( 30.2-78 .5 ) , p = 0.005 ; respectively ] .
RESULTS	Pulmonary penetration ( % ) was higher in the CI group , as confirmed by a Monte Carlo simulation [ 98.8 ( IQR 93.8-104 .3 ) vs 87.1 ( IQR 78.7-95 .4 ) ; p < 0.001 ] .
CONCLUSIONS	In critically ill obese patients affected by VAP , LNZ CI may overcome the limits of standard administration but these advantages are less evident with difficult to treat pathogens ( MIC = 4 mg/L ) .
CONCLUSIONS	These data support the usefulness of LNZ continuous infusion , combined with therapeutic drug monitoring ( TDM ) , in selected critically ill populations .

###25616485
OBJECTIVE	The long-term efficacy and safety of responsive direct neurostimulation was assessed in adults with medically refractory partial onset seizures .
METHODS	All participants were treated with a cranially implanted responsive neurostimulator that delivers stimulation to 1 or 2 seizure foci via chronically implanted electrodes when specific electrocorticographic patterns are detected ( RNS System ) .
METHODS	Participants had completed a 2-year primarily open-label safety study ( n = 65 ) or a 2-year randomized blinded controlled safety and efficacy study ( n = 191 ) ; 230 participants transitioned into an ongoing 7-year study to assess safety and efficacy .
RESULTS	The average participant was 34 ( 11.4 ) years old with epilepsy for 19.6 ( 11.4 ) years .
RESULTS	The median preimplant frequency of disabling partial or generalized tonic-clonic seizures was 10.2 seizures a month .
RESULTS	The median percent seizure reduction in the randomized blinded controlled trial was 44 % at 1 year and 53 % at 2 years ( p < 0.0001 , generalized estimating equation ) and ranged from 48 % to 66 % over postimplant years 3 through 6 in the long-term study .
RESULTS	Improvements in quality of life were maintained ( p < 0.05 ) .
RESULTS	The most common serious device-related adverse events over the mean 5.4 years of follow-up were implant site infection ( 9.0 % ) involving soft tissue and neurostimulator explantation ( 4.7 % ) .
CONCLUSIONS	The RNS System is the first direct brain responsive neurostimulator .
CONCLUSIONS	Acute and sustained efficacy and safety were demonstrated in adults with medically refractory partial onset seizures arising from 1 or 2 foci over a mean follow-up of 5.4 years .
CONCLUSIONS	This experience supports the RNS System as a treatment option for refractory partial seizures .
METHODS	This study provides Class IV evidence that for adults with medically refractory partial onset seizures , responsive direct cortical stimulation reduces seizures and improves quality of life over a mean follow-up of 5.4 years .

###24669597
BACKGROUND	Patients with diabetes often develop ocular complications .
BACKGROUND	The most common and most blinding of these complications , however , is diabetic retinopathy .
BACKGROUND	The objective of this study was to compare the retinal neovessels regression in Proliferative Diabetic Retinopathy ( PDR ) treated with Pan Retinal Photocoagulation ( PRP ) versus panretinal photocoagulation plus Intra Vitreal Bevacizumab ( IVB ) .
METHODS	A comparative study was conducted at Khyber Institute of Ophthalmic Medical Sciences , Hayatabad Medical Complex , Peshawar from 1st October 2010 to 31st August 2011 .
METHODS	A total of 54 eyes were randomised into two groups .
METHODS	Neovessels status was assessed before and at every follow up visit .
METHODS	Neo Vessels on the Disc ( NVDs ) were assessed as per percentage of NVD occupying the disc surface whereas Neo Vessels Elsewhere ( NVE ) were also assessed as per reference to disc surface diameter .
RESULTS	Neovascularization on the disc was 40 + / - 5 % at presentation which increased to 50 + / - 7 % on 30th day and stabilised to 40 + / - 6 % on day 90 in PRP group .
RESULTS	In PRP-plus group , 40 + / - 7 % NVD regressed to 10 + / - 5 % on 30th day and 11 + / - 3 % on day 90 .
RESULTS	The NVE in PRP group was 2 + / - 0.75 % at baseline , 2.25 + / - 0.75 % on 30th day , and 2.00 + / - 0.50 % on day 90 .
RESULTS	In PRP-plus group it was 2 + / - 0.50 % at baseline , 1 + / - 0.5 % on day 30 , and 0.75 + / - 0.25 % on day 90 .
RESULTS	On day 90 both the groups had highly significant different NVD ( p = 0.00008 ) and NVE ( p = 0.0001 ) .
CONCLUSIONS	Intra Vitreal Bevacizumab in short term is effective as adjunctive treatment to PRP with early and higher rate of retinal neovessels regression than PRP alone in PDR patients .

###25225151
BACKGROUND	To determine the efficacy of combining of Boswellia serrata L. resin and the root of Cyperus scariosus L. plus PFMT in reproductive age women with stress urinary incontinence .
METHODS	A prospective , single-blind , placebo-controlled , randomized trial was conducted .
METHODS	The patients were randomized to receive orally either combination of equal quantity of B.serrata and C.scariosus ( 2g ) ( n = 30 ) or placebo ( n = 30 ) respectively twice daily for 8 weeks in addition to pelvic floor muscle training in both groups .
METHODS	The outcome was one hour pad test .
METHODS	The results were analyzed using parametric and nonparametric test .
RESULTS	The improvement in the test and control group was 60 % and 37 % respectively .
RESULTS	Between the group comparison was statistically significant ( P = 0.035 ) .
RESULTS	The intra group comparison of one hour pad test was statistically significant in both groups ( P < 0.001 ) .
RESULTS	No adverse effects were noted .
CONCLUSIONS	The test group was more effective than control group in women with SUI .

###24290575
OBJECTIVE	Surgical resection has been the mainstay of curative treatment of early stage lung cancer in selected patients .
OBJECTIVE	We evaluated survival and patterns of recurrence after surgical resection for early stage lung cancer from the American College of Surgeons Oncology Group Z0030/Alliance trial .
METHODS	One thousand eighteen patients enrolled in the Z0030 trial were analyzed according to clinical T stage .
METHODS	Differences between groups were compared using the 2-sample rank test or ( 2 ) test .
METHODS	Log rank test and Cox proportional hazards regression were used to compare survival and recurrence .
METHODS	To compare patients who underwent open versus video-assisted thoracoscopic surgery ( VATS ) resections , propensity-score matched analysis was performed .
METHODS	Seven hundred fifty-two patients ( 66 undergoing VATS and 686 undergoing open surgery ) were classified into 5 equal-sized propensity-score groups .
METHODS	Proportional hazards regression was used to compare these outcomes .
RESULTS	There were 578 patients with cT1 tumors and 440 patients with cT2 tumors .
RESULTS	Median follow-up was 6.7 years .
RESULTS	Median overall survival was 9.1 years ( stage T1 ) and 6.5 years ( stage T2 ) .
RESULTS	Overall survival at 5 years was 72 % ( stage T1 ) and 55 % ( stage T2 ) .
RESULTS	Local recurrence-free survival at 5 years was 95 % ( stage T1 ) and 91 % ( stage T2 ) ( P = .015 ) .
RESULTS	Among patients with stage T1 cancer , 4.2 % ( 23 out of 542 ) had local recurrences , whereas 7.3 % ( 30 out of 409 ) of those with stage T2 tumors had local failure .
RESULTS	There was no difference in the development of new primary tumors between stage T1 and stage T2 groups .
RESULTS	In the propensity-score matched analysis of VATS versus open lobectomy patients , there was no difference in overall survival , disease-free survival , and freedom from development of a new primary tumor .
CONCLUSIONS	Results of patients with resected early stage non-small cell carcinoma from a large-scale , multicenter trial serve as benchmarks against which to compare nonsurgical therapies for early stage lung cancer .
CONCLUSIONS	Propensity-score matched analysis shows no difference in survival between patients undergoing VATS and open lobectomy .

###25853877
OBJECTIVE	This study was conducted to investigate the effects of creatine loading and resistance training on the homocysteine and lipid profiles of young males .
METHODS	Sixty male University students ( 22.34 2.19 years , 1.79 0.08 m , 77.18 12.57 kg , 15.48 4.57 % body fat ) were randomly divided in to three groups ; control ( CG = 20 ) , creatine supplement ( CEG = 20 ) and placebo ( PEG = 20 ) .
METHODS	Both CEG and PEG participated in a same resistance-training regimen and either taking a creatine supplement ( 25 g/d for the first 5 days followed 5 g/d thereafter ) or the same amount of placebo for 8 weeks .
METHODS	Participants in CG did not take any creatine supplementation and not engage any exercise program .
METHODS	After the body composition were assessed , the homocysteine ( Hcy ) concentrations , blood lipids , folic acid and vitamin B12 levels of all the participants were measured at the beginning and end of the eight weeks of resistance training .
RESULTS	The analysis of the data indicated that the Hcy levels of the CEG after resistance training and receiving the creatine supplement ( 9.33 4.60 ) was significantly lower than that of baseline ( 12.66 5.89 ) measurements , F ( 1,18 ) = 12.28 , P = 0.00 .
RESULTS	No significant differences were seen in the Hcy levels of the PEG ( 15.01 10.87 ) after 8 weeks of training and receiving a placebo ( 12.46 12.50 ) , F ( 1,16 ) = 4.65 , P = 0.05 .
RESULTS	Furthermore , there were no significant differences among groups in terms of Hcy levels , F ( 2,52 ) = 1.72 , P = 0.19 .
CONCLUSIONS	The present study suggests that as well as strength gain ; creatine supplementation with resistance training may afford some protection against emerging cardiovascular risk factors .

###25077835
OBJECTIVE	To compare rates and severity of complications between infants undergoing cataract surgery with and without intraocular lens ( IOL ) implantation .
METHODS	Prospective randomized clinical trial .
METHODS	A total of 114 infants were enrolled in the Infant Aphakia Treatment Study , a randomized , multi-center ( 12 ) clinical trial comparing the treatment of unilateral aphakia in patients under 7 months of age with a primary IOL implant or contact lens .
METHODS	The rate , character , and severity of intraoperative complications , adverse events , and additional intraocular surgeries during the first 5 postoperative years in the 2 groups were examined .
RESULTS	There were more patients with intraoperative complications ( 28 % vs 11 % , P = .031 ) , adverse events ( 81 % vs 56 % , P = .008 ) , and more additional intraocular surgeries ( 72 % vs 16 % , P < .0001 ) in the IOL group than in the contact lens group .
RESULTS	However , the number of patients with adverse events in the contact lens group increased ( 15 to 24 ) in postoperative years 2-5 compared to the first postoperative year , while it decreased ( 44 to 14 ) in years 2-5 compared to the first postoperative year in the IOL group .
RESULTS	If only one half of the patients in the contact lens ( aphakic ) group eventually undergo secondary IOL implantation , the number of additional intraocular surgeries in the 2 groups will be approximately equal .
CONCLUSIONS	The increased rate of complications , adverse events , and additional intraocular surgeries associated with IOL implantation in infants < 7 months of age militates toward leaving babies aphakic if it is considered likely that the family will be successful with contact lens correction .

###25135191
OBJECTIVE	The aims of this study were ( 1 ) to assess the long-term effects of a collaborative care intervention for patients with depression on process of care outcomes , and ( 2 ) to describe whether case management was continued after the end of the original one-year intervention .
METHODS	This 24-month follow-up of a randomized controlled trial took place 12 months after the end of the 1-year intervention .
METHODS	Data collection occurred by means of self-rating questionnaires and from medical records .
METHODS	We calculated linear mixed and logistic generalized estimating equation models .
RESULTS	Of the 626 patients included at baseline , 439 ( 70.1 % ) participated in this follow-up .
RESULTS	Intervention recipients gave higher ratings than control recipients in terms of mean overall Patient Assessment of Chronic Illness Care ( PACIC ) scores ( 3.12 vs. 2.86 ; P = .019 ) , but no difference was found in medication adherence ( mean Morisky score 2.59 vs. 2.65 , P = .56 ) , prescribed antidepressant medications ( 60.2 % vs. 55.1 % ; P = .25 ) , visits to the family physician ( 15.96 vs. 14.46 , P = .58 ) or mental health specialist ( 3.01 vs. 2.94 , P = .94 ) over the 12 month follow-up period .
RESULTS	Case management was continued for 47 ( 22.5 % ) selected intervention patients after the original intervention had ended .
CONCLUSIONS	At 24 months , intervention and control recipients had different PACIC ratings , but other process of care outcomes did not differ .
CONCLUSIONS	The main effects of the intervention are apparent at 12 months .

###25490946
BACKGROUND	Effective lifestyle interventions are needed to prevent noncommunicable diseases in low - and middle-income countries .
BACKGROUND	We analyzed the effects of a school-based health promotion intervention on physical fitness after 28 months and explored if the effect varied with important school characteristics .
BACKGROUND	We also assessed effects on screen time , physical activity and BMI .
RESULTS	We performed a cluster-randomized pair matched trial in schools in urban Ecuador .
RESULTS	The intervention included an individual and environmental component tailored to the local context and resources .
RESULTS	Primary outcomes were physical fitness ( EUROFIT battery ) , screen time ( questionnaires ) and physical activity ( accelerometers ) .
RESULTS	Change in BMI was a secondary outcome .
RESULTS	A total of 1440 grade 8 and 9 adolescents ( intervention : n = 700 , 48.6 % ) and 20 schools ( intervention : n = 10 , 50 % ) participated .
RESULTS	Data of 1083 adolescents ( intervention : n = 550 , 50.8 % ) from 20 schools were analyzed .
CONCLUSIONS	A school-based intervention with an individual and environment component can improve physical fitness and can minimize the decline in physical activity levels from childhood into adolescence in urban Ecuador .
BACKGROUND	Clinicaltrials.gov identifier NCT01004367 .

###25088349
BACKGROUND	Recently , various near-infrared vascular imaging devices aimed at facilitating peripheral intravenous cannulation ( PIC ) were introduced , all claiming to increase success rate of PIC .
BACKGROUND	We evaluated the clinical utility of a near-infrared vascular imaging device ( VascuLuminator ( ) ) in pediatric patients who were referred to the anesthesiologist because of difficult cannulation .
METHODS	There were 226 consecutive children referred to pediatric anesthesiologists by the treating pediatrician of the in - and outpatient clinic , because of difficulties with intravenous cannulation , were included in this cluster randomized clinical trial .
METHODS	The presence and use of the near-infrared vascular imaging device for PIC was randomized in clusters of 1 week .
METHODS	Success at first attempt ( Fisher exact test ) and time to successful cannulation ( Log-rank test ) were assessed to evaluate differences between groups .
RESULTS	Success at first attempt in the group with the VascuLuminator ( ) ( 59 % ) was not significantly different from the control group ( 54 % , P = 0.41 ) , neither was the median time to successful cannulation : 246 s and 300 s , respectively ( P = 0.54 ) .
CONCLUSIONS	Visualization of blood vessels with near-infrared light and with near-infrared vascular imaging device did not improve success of PIC in pediatric patients who are known difficult to cannulate .

###24879492
OBJECTIVE	The high prevalence of obstructive sleep apnea in patients with resistant hypertension could be mediated by an activation of the renin-angiotensin-aldosterone system .
OBJECTIVE	This study assessed the impact of continuous positive airway pressure ( CPAP ) treatment on plasma aldosterone concentration ( PAC ) .
METHODS	One hundred and twenty-four patients with resistant hypertension were assessed , and those who fulfilled inclusion criteria ( n = 116 ) underwent full night polysomnography , 24-h ambulatory blood pressure monitoring , and PAC measurement .
METHODS	Patients with an apnea-hypopnea index above 15 ( n = 102 ) were randomized to CPAP ( n = 50 ) or to conventional treatment ( n = 52 ) for 3 months .
RESULTS	Seventy-eight patients completed the follow-up ( 36 CPAP , 42 conventional treatment ) ; 58 had true resistant hypertension ( 74.3 % ) , whereas 20 had white-coat resistant hypertension ( 25.6 % ) .
RESULTS	Most patients were men ( 70.7 % ) , age 58.39.4 years , and the mean apnea-hypopnea index was 50.121.6 .
RESULTS	In patients with true resistant hypertension , CPAP achieved a significant decrease in most 24-h BP measurements and a nonsignificant decrease in PAC ( 258.7 vs. 22.79 ng/dl ; P < 0.182 ) .
RESULTS	In patients with white-coat resistant hypertension , CPAP achieved a significant decrease in PAC ( 26.111.2 vs. 18.910.1 ng/dl ; P < 0.041 ) and in night-time DBP .
RESULTS	After adjustment , a weak but significant association was found between cumulative time spent with SaO2 below 90 % ( CT90 % ) and baseline PAC ( P < 0.047 , R 0.019 ) , and between changes in PAC and changes in office DBP ( P < 0.020 , R 0.083 ) CONCLUSIONS : : Night-time hypoxemia and changes in DBP showed an association with baseline and changes in PAC , respectively .
RESULTS	CPAP achieved a significant reduction in PAC only in patients with white-coat resistant hypertension , although the CPAP effect on BP was highest in patients with true resistant hypertension .

###24670200
BACKGROUND	The Swiss health ministry launched a national quality program ` QualiCCare ' in 2011 to improve health care for patients with COPD.The aim of this study is to determine whether participation in the COPD quality initiative ( ` QualiCCare ' ) improves adherence to recommended clinical processes and shows impact on patients ' COPD care and on the impact of COPD on a person 's life .
METHODS	CAROL is a cluster-randomized controlled trial with randomization on the general practioner ( GP ) level .
METHODS	Thirty GPs will be randomly assigned to equally sized intervention group or control group.Each GP will approach consecutively and regardless of the reason for the current consultation , patients aged 45 years or older , with a smoking history of ten pack-years ( PY ) .
METHODS	Patients with confirmed ( by spirometric evaluation ) COPD will be included in the study .
METHODS	GPs in the intervention group will receive ` QualiCCare ' education , which addresses knowledge , decision-making and behavioural aspects as well as delivery of care according to COPD quality indicators and evidence-based key elements .
METHODS	In the control group , no educational intervention will be applied and COPD patients will be treated as usual .
METHODS	The study period is one year.The primary outcome measure is an aggregated score of relevant clinical processes defining elements in the care of patients with COPD : smoking cessation counseling , influenza vaccination , motivation for physical activity , appropriate pharmacotherapy , patient education and collaborative care .
METHODS	Given a power of 90 % and a significance level alpha of 5 % , 15 GPs recruiting eight patients each will be necessary in both study arms .
METHODS	With an assumed dropout rate of 20 % , 288 patients will need to be included .
CONCLUSIONS	It is important to develop and implement interventions that add value to COPD care considering quality and efficiency .
CONCLUSIONS	Care pathways modifying the knowledge and behavior of physicians have the potential for improving care by transferring knowledge to clinical practice .
BACKGROUND	ClinicalTrials.gov : NCT01921556 .

###24837559
BACKGROUND	There is a lack of knowledge about the patient 's experience of excess skin after bariatric surgery in patients with body mass index , ( BMI ) > 50 kg/m ( 2 ) .
BACKGROUND	The objective of this study was to evaluate experience of excess skin after laparoscopic biliopancreatic diversion with duodenal switch ( BPD/DS ) or laparoscopic Roux-en-Y gastric bypass ( LRYGB ) and explore possible gender differences .
BACKGROUND	Another aim was to analyze possible correlation between the reported experiences of excess skin with changes in weight , BMI , and hip and waist circumference after surgery .
METHODS	One and/or 2 years after gastric bypass or duodenal switch surgery 57 patients responded to a specific questionnaire .
METHODS	The questionnaire included questions about the amount of excess skin and how much discomfort it caused .
METHODS	Furthermore , the patients were measured concerning weight and waist and hip circumference .
RESULTS	One year after surgery , a majority of the patients experienced excess skin scored as > 2 ( `` a lot of '' or `` very much '' ) .
RESULTS	The patients in the BPD/DS group experienced significantly more excess skin compared to patients in the LRYGB group .
RESULTS	Women experienced more excess skin and discomfort on several body parts than men .
RESULTS	The correlations between changes in BMI and the reported experience and discomfort of excess skin were low .
RESULTS	There was a low to moderate correlation between changes in waist and hip circumference measures and the experience of excess skin on stomach and buttocks .
CONCLUSIONS	Weight loss after LRYGB and BPD/DS in super-obese patients is associated with substantial discomfort from excess skin .
CONCLUSIONS	Women reported more discomfort and experienced more excess skin than men .
CONCLUSIONS	There was a low correlation between experience of excess skin and changes in weight , BMI , and circumference measures .

###25530384
OBJECTIVE	To compare the efficacy of 4 mg and 8 mg doxazosin XL treatments in patients with benign prostatic hyperplasia-related lower urinary tract symptoms and determine the efficiency of 8 mg in those patients with inadequate response to 4 mg .
METHODS	A total of 162 patients were included in this study .
METHODS	Of the patients , 108 were randomized to receive 4 mg doxazosin XL ( group 1 ) , and 54 were randomized to receive 8 mg ( group 2 ) treatments .
METHODS	After 1 month of treatment , 31 patients in group 1 whose quality of life ( QoL ) score was unchanged or had deteriorated were switched to 8 mg doxazosin XL treatment ( group 1b ) .
RESULTS	The mean age was 59.8 years .
RESULTS	After 1 month of treatment , the mean alteration in the International Prostate Symptom Score was 3.9 and 5.2 ( P = .028 ) , for the maximum urinary flow rate ( Q ( max ) ) , it was 3.0 and 3.6 mL/s ( P = .206 ) , and for the QoL score it was 1.3 and 1.7 ( P = .038 ) in groups 1 and 2 , respectively .
RESULTS	For group 1b , during the period in which the patients were receiving 4 and 8 mg doxazosin XL treatments ; the International Prostate Symptom Score changes were 1.3 and 3.6 ( P < .001 ) , the Q ( max ) changes were 1.6 and 3.2 mL/s ( P < .019 ) , and the QoL changes were 0.4 and 1.8 ( P < .001 ) in groups 1 and 2 , respectively .
CONCLUSIONS	With no changes in side effects , 8 mg doxazosin XL treatment is an efficient choice for patients who did not have an adequate response to 4 mg doxazosin XL treatment .

###24642580
OBJECTIVE	Studies conducted in large populations of patients and providing full information on Helicobacter pylori ( H. pylori ) antibiotic resistance are needed to determine the efficacy of sequential therapy ( SQT ) against this pathogen .
OBJECTIVE	This study compared eradication rates with SQT and standard triple therapy ( STT ) , and evaluated the impact of antibiotic resistance on outcomes .
METHODS	The study population included adults with positive H. pylori culture presenting at four centers in China between March 2008 and December 2010 .
METHODS	Patients were randomly assigned to 10 days of treatment with esomeprazole , amoxicillin , and clarithromycin ( STT ; n = 140 ) or to 5 days of treatment with esomeprazole and amoxicillin , followed by 5 days of esomeprazole , clarithromycin , and tinidazole ( SQT ; n = 140 ) .
METHODS	Eradication was assessed 8-12 weeks after treatment .
RESULTS	There was no significant difference between the eradication rates achieved with STT ( 66.4 % ( 95 % confidence interval ( CI ) 59.3-74 .3 ) ) and SQT ( 72.1 % ( 65.0-79 .3 ) ; P = 0.300 ) in either the intention-to-treat analysis or the per-protocol analysis ( 72.7 % ( 65.6-79 .7 ) and 76.5 % ( 69.7-83 .3 ) , respectively ; P = 0.475 ) .
RESULTS	Clarithromycin resistance ( CLA-R , odds ratio ( OR ) = 8.34 ( 3.13-22 .26 ) , P < 0.001 ) and metronidazole resistance ( MET-R , OR = 7.14 ( 1.52-33 .53 ) , P = 0.013 ) both independently predicted treatment failure in the SQT group .
RESULTS	Patients in the SQT group with dual CLA-R and MET-R had a lower eradication rate ( 43.9 % ) than those with isolated CLA-R ( 88.9 % , P = 0.024 ) or isolated MET-R ( 87.8 % , P < 0.001 ) .
CONCLUSIONS	H. pylori eradication rates with STT and SQT were compromised by antibiotic resistance .
CONCLUSIONS	SQT may be suitable in regions with high prevalence of isolated CLA-R , but it is unsatisfactory when both CLA-R and MET-R are present .

###25099523
OBJECTIVE	Pruritus is common among patients with end-stage renal disease undergoing dialysis , and the pathogenesis can be explained by several mechanisms .
OBJECTIVE	However , there is no definite evidence supporting them , which limits the relative efficacy of any individual treatment option .
OBJECTIVE	In this paper , we aimed to compare pregabalin with ondansetron in treatment of uraemic pruritus ( UP ) in dialysis patients .
METHODS	In this 12-week prospective , randomized , and double-blind trial , we assessed the efficacy and side effects in UP patients undergoing dialysis .
METHODS	Patients were randomly assigned to receive 12 weeks of 75 mg twice-weekly pregabalin or 8 mg/day ondansetron or a placebo .
METHODS	Visits were scheduled at 0 , 2 , 4 , 6 , 8 , and 12 weeks after treatment .
METHODS	The severity of pruritus was evaluated using Visual Analogue Scale and modified Duo 's VAG Scale .
METHODS	Quality of sleep was evaluated using the Pittsburgh sleep quality index .
METHODS	The effect of UP on health-related quality of life was assessed using the Chinese version of the 12-item short-form ( SF-12 ) general health survey .
METHODS	Baseline laboratory data and demographic characteristics were recorded from patient charts .
RESULTS	Finally , 179 ( 108 males , 71 females , aged 54.711.3 years old ) out of the 188 patients completed the 12-week study .
RESULTS	Of five patients who stopped pregabalin treatment due to side effects , two patients reported an improvement in nausea and vomiting among those receiving ondansetron .
RESULTS	Two patients dropped out for renal transplantation .
RESULTS	The 179 patients included 62 cases from the pregabalin group , 60 from the ondansetron group , and 57 from the placebo group .
RESULTS	Over the 12 weeks , only pregabalin improved UP significantly .
RESULTS	The severity of pruritus was reduced significantly in the pregabalin group compared with the ondansetron and the placebo groups .
RESULTS	The final pruritus scores were not different between the ondansetron and the placebo groups .
RESULTS	Pruritus absolutely disappeared in two patients following renal transplantation .
CONCLUSIONS	Pregabalin is an effective alternative for treatment of uraemic pruritus .
CONCLUSIONS	Ondansetron has negligible effect on uremic pruritus and is expensive .
CONCLUSIONS	A larger sample size may be needed to demonstrate the effect of ondansetron in uraemic pruritus .

###24424357
OBJECTIVE	To investigate whether granulocyte colony-stimulating factor ( G-CSG ) affects endometrial thickness , implantation rates , and clinical pregnancy rates in routine , unselected IVF cycles .
METHODS	Registered , individually randomized , two-group , parallel double-blinded placebo-controlled clinical trial .
METHODS	Academically affiliated private clinical and research center .
METHODS	141 consecutive , unselected , consenting women with no history of renal disease , sickle cell disease , or malignancy who were undergoing IVF .
METHODS	Sealed , numbered , opaque envelopes assigned 73 patients to receive G-CSF ( Filgrastim , Amgen , 300 g/1 .0 mL ) and 68 to receive placebo ( saline ) .
METHODS	Endometrial thickness , clinical pregnancy , and embryo implantation rates .
RESULTS	The mean age for the whole study group was 39.59 5.56 years ( G-CSF : 39.79 5.13 years ; placebo : 39.38 6.03 years ) .
RESULTS	Endometrial thickness statistically significantly increased over the 5-day observation period for the whole group by approximately 1.36 mm .
RESULTS	The increase in the G-CSF group was not statistically significantly different from the control group .
RESULTS	Statistical models looking at treatment effects on clinical pregnancy and implantation rates demonstrated no effect of G-CSF treatment .
RESULTS	There were no adverse events for either treatment group .
CONCLUSIONS	In normal IVF patients , G-CSF does not affect endometrial thickness , implantation rates , or clinical pregnancy rates .
CONCLUSIONS	Because these results were obtained in an older patient population , they may not necessarily apply to younger women .
BACKGROUND	NCT01202656 .

###24586994
BACKGROUND	Dilated cardiomyopathy is characterized by left ventricular dilatation and dysfunction .
BACKGROUND	Inflammation and adverse remodeling of the extracellular matrix may be involved in the pathogenesis .
BACKGROUND	Statins reduce levels of low density lipoprotein cholesterol , but may also attenuate inflammation and affect matrix remodeling .
BACKGROUND	We hypothesized that treatment with rosuvastatin would reduce or even reverse left ventricular remodeling in dilated cardiomyopathy .
METHODS	In this multicenter , randomized , double blind , placebo-controlled study , 71 patients were randomized to 10 mg of rosuvastatin or matching placebo .
METHODS	Physical examination , blood sampling , echocardiography and cardiac magnetic resonance imaging were performed at baseline and at six months ' follow-up .
METHODS	The pre-specified primary end point was the change in left ventricular ejection fraction from baseline to six months .
RESULTS	Over all , left ventricular ejection fraction improved 5 percentage points over the duration of the study , but there was no difference in the change in left ventricular ejection fraction between patients allocated to rosuvastatin and those allocated to placebo .
RESULTS	Whereas serum low density lipoprotein cholesterol concentration fell significantly in the treatment arm , rosuvastatin did not affect plasma or serum levels of a wide range of inflammatory variables , including C-reactive protein .
RESULTS	The effect on markers of extracellular matrix remodeling was modest .
CONCLUSIONS	Treatment with rosuvastatin does not improve left ventricular ejection fraction in patients with dilated cardiomyopathy .
BACKGROUND	ClinicalTrials.gov NCT00505154 .

###25607562
BACKGROUND	Current studies have demonstrated the efficacy and safety of laser intervention in the treatment of onychomycosis .
BACKGROUND	The objective of this study was to compare the efficacy of long-pulsed Nd : YAG 1064 nm laser for treatment of toenails onychomycosis with fingernails onychomycosis .
METHODS	One hundred and twelve affected fingernails or toenails in 37 patients with onychomycosis were randomized into Group 1 ( 22 patients with 50 affected fingernails ) and Group 2 ( 15 patients with 62 affected toenails ) .
METHODS	These patients were further classified into three subgroups ( Grade II , III , and IV ) according to Scoring Clinical Index of Onychomycosis .
METHODS	All the affected nails were treated with long-pulse Nd : YAG 1064 nm laser intervention , once weekly , for continuous weeks , and were followed up for 24 weeks .
RESULTS	The response rates at weeks 8 , 16 , and 24 were 0 , 0 and 52 % , respectively , for Group 1 , and 10 , 32 and 71 % for Group 2 .
RESULTS	The inter-group difference in efficacy was statistically significant ( P < 0.05 ) .
RESULTS	Even in the same subgroup , the response rate of Group 2 was higher than that of Group 1 .
CONCLUSIONS	The efficacy of long-pulsed Nd : YAG 1064 nm laser intervention against affected toenails is superior to that against fingernails .
CONCLUSIONS	It is also effective for treatment of onychomycosis with different severity .

###25268365
BACKGROUND	Physical therapy is recommended for the management of axial spondyloarthritis ( axSpA ) and flexibility exercises have traditionally been the main focus .
BACKGROUND	Cardiovascular ( CV ) diseases are considered as a major health concern in axSpA and there is strong evidence that endurance and strength exercise protects against CV diseases .
BACKGROUND	Therefore , the aim of this study was to investigate the efficacy of high intensity endurance and strength exercise on disease activity and CV health in patients with active axSpA .
METHODS	In a single blinded randomized controlled pilot study the exercise group ( EG ) performed 12 weeks of endurance and strength exercise while the control group ( CG ) received treatment as usual .
METHODS	The primary outcome was the Ankylosing Spondylitis ( AS ) Disease Activity Score ( ASDAS ) .
METHODS	Secondary outcomes included patient reported disease activity ( Bath AS Disease Activity Index [ BASDAI ] ) , physical function ( Bath AS Functional Index [ BASFI ] ) , and CV risk factors measured by arterial stiffness ( Augmentation Index [ Alx ] ) and Pulse Wave Velocity [ PWV ] ) , cardiorespiratory fitness ( VO2 peak ) and body composition .
METHODS	ANCOVA on the post intervention values with baseline values as covariates was used to assess group differences , and Mann Whitney U-test was used for outcomes with skewed residuals .
RESULTS	Twenty-eight patients were included and 24 ( EG , n = 10 , CG , n = 14 ) completed the study .
RESULTS	A mean treatment effect of -0.7 ( 95 % CI : -1.4 , 0.1 ) was seen in ASDAS score .
RESULTS	Treatment effects were also observed in secondary outcomes ( mean group difference [ 95 % CI ] ) : BASDAI : -2.0 ( -3.6 , -0.4 ) , BASFI : -1.4 ( -2.6 , -0.3 ) , arterial stiffness ( estimated median group differences [ 95 % CI ] ) : AIx ( % ) : -5.3 ( -11.0 , -0.5 ) , and for PVW ( m/s ) : -0.3 ( -0.7 , 0.0 ) , VO2 peak ( ml/kg/min ) ( mean group difference [ 95 % CI ] : 3.7 ( 2.1 , 5.2 ) and trunk fat ( % ) : -1.8 ( -3.0 , -0.6 ) .
RESULTS	No adverse events occurred .
CONCLUSIONS	High intensity exercise improved disease activity and reduced CV risk factors in patients with active axSpA .
CONCLUSIONS	These effects will be further explored in a larger trial .
BACKGROUND	ClinicalTrials.gov NCT01436942 .

###25268295
OBJECTIVE	Low vitamin D status is linked to increased mortality and morbidity in patients who are critically ill .
OBJECTIVE	It is unknown if this association is causal .
OBJECTIVE	To investigate whether a vitamin D3 treatment regimen intended to restore and maintain normal vitamin D status over 6 months is of health benefit for patients in ICUs .
METHODS	A randomized double-blind , placebo-controlled , single-center trial , conducted from May 2010 through September 2012 at 5 ICUs that included a medical and surgical population of 492 critically ill adult white patients with vitamin D deficiency ( 20 ng/mL ) assigned to receive either vitamin D3 ( n = 249 ) or a placebo ( n = 243 ) .
METHODS	Vitamin D3 or placebo was given orally or via nasogastric tube once at a dose of 540,000 IU followed by monthly maintenance doses of 90,000 IU for 5 months .
METHODS	The primary outcome was hospital length of stay .
METHODS	Secondary outcomes included , among others , length of ICU stay , the percentage of patients with 25-hydroxyvitamin D levels higher than 30 ng/mL at day 7 , hospital mortality , and 6-month mortality .
METHODS	A predefined severe vitamin D deficiency ( 12 ng/mL ) subgroup analysis was specified before data unblinding and analysis .
RESULTS	A total of 475 patients were included in the final analysis ( 237 in the vitamin D3 group and 238 in the placebo group ) .
RESULTS	The median ( IQR ) length of hospital stay was not significantly different between groups ( 20.1 days [ IQR , 11.1-33 .3 ] for vitamin D3 vs 19.3 days [ IQR , 11.1-34 .9 ] for placebo ; P = .98 ) .
RESULTS	Hospital mortality and 6-month mortality were also not significantly different ( hospital mortality : 28.3 % [ 95 % CI , 22.6 % -34.5 % ] for vitamin D3 vs 35.3 % [ 95 % CI , 29.2 % -41.7 % ] for placebo ; hazard ratio [ HR ] , 0.81 [ 95 % CI , 0.58-1 .11 ] ; P = .18 ; 6-month mortality : 35.0 % [ 95 % CI , 29.0 % -41.5 % ] for vitamin D3 vs 42.9 % [ 95 % CI , 36.5 % -49.4 % ] for placebo ; HR , 0.78 [ 95 % CI , 0.58-1 .04 ] ; P = .09 ) .
RESULTS	For the severe vitamin D deficiency subgroup analysis ( n = 200 ) , length of hospital stay was not significantly different between the 2 study groups : 20.1 days ( IQR , 12.9-39 .1 ) for vitamin D3 vs 19.0 days ( IQR , 11.6-33 .8 ) for placebo .
RESULTS	Hospital mortality was significantly lower with 28 deaths among 98 patients ( 28.6 % [ 95 % CI , 19.9 % -38.6 % ] ) for vitamin D3 compared with 47 deaths among 102 patients ( 46.1 % [ 95 % CI , 36.2 % -56.2 % ] ) for placebo ( HR , 0.56 [ 95 % CI , 0.35-0 .90 ] , P for interaction = .04 ) , but not 6-month mortality ( 34.7 % [ 95 % CI , 25.4 % -45.0 % ] for vitamin D3 vs 50.0 % [ 95 % CI , 39.9 % -60.1 % ] for placebo ; HR , 0.60 [ 95 % CI , 0.39-0 .93 ] , P for interaction = .12 ) .
CONCLUSIONS	Among critically ill patients with vitamin D deficiency , administration of high-dose vitamin D3 compared with placebo did not reduce hospital length of stay , hospital mortality , or 6-month mortality .
CONCLUSIONS	Lower hospital mortality was observed in the severe vitamin D deficiency subgroup , but this finding should be considered hypothesis generating and requires further study .
BACKGROUND	clinicaltrials.gov Identifier : NCT01130181 .

###25942457
OBJECTIVE	To assess the role of sexual relationships on levels and patterns of adherence to medication for pre-exposure prophylaxis against HIV .
METHODS	We enrolled 1147 HIV-negative individuals in long-term serodiscordant relationships at 3 sites in Uganda from the Partners Pre-exposure Prophylaxis Study , a randomized placebo-controlled trial of daily oral tenofovir and emtricitabine/tenofovir .
METHODS	We used generalized estimation equations to assess the effects of sexual relationships on low adherence ( < 80 % ) and on gaps in adherence .
RESULTS	Fifty-three percent were male , 51 % were 18-34 years and 24 % were polygamous .
RESULTS	Participants who reported sex in the past month with someone other than their primary partner and with < 100 % condom use were more than twice as likely to have low adherence [ adjusted odds ratio ( aOR ) = 2.48 , 95 % CI : 1.70 to 3.62 ] compared with those who had sex with only their primary partners and 100 % condom use .
RESULTS	Using the same reference group , those who abstained from sex in the previous month had 30 % increased odds of low adherence ( aOR = 1.30 , 95 % CI : 1.05 to 1.62 ) and participants in nonpolygamous marriages who reported sex with both their primary and other partners and < 100 % condom use were almost twice as likely to be low adherers ( aOR = 1.76 , 95 % CI : 1.01 to 3.08 ) .
RESULTS	At least one 72-hour gap in adherence was seen in 598 participants ( 54.7 % ) ; 23.2 % had at least one 1-week gap .
CONCLUSIONS	Risk of low overall adherence was higher in participants who reported sex outside primary partnerships and suboptimal condom use , as well as in those who abstained from sex .
CONCLUSIONS	Adherence gaps were common , potentially creating risk for HIV acquisition .

###24685997
BACKGROUND	Excessive and inadequate gestational weight gain can complicate a woman 's pregnancy and put her and her child at risk for poor delivery and birth outcomes .
BACKGROUND	Further , feeding and activity habits established early in life can significantly impact the development of childhood obesity .
METHODS	The on-going Delta Healthy Sprouts Project is a randomized , controlled , comparative trial testing the efficacy of two Maternal , Infant , and Early Childhood Home Visiting programs on weight status and health behaviors of 150 mothers and their infants residing in the rural Mississippi Delta region of the United States .
METHODS	Women are enrolled in their second trimester of pregnancy and randomized to one of two treatment arms .
METHODS	The control arm curriculum is based on Parents as Teachers , an evidence based approach to increase parental knowledge of child development and improve parenting practices .
METHODS	The experimental arm , labeled Parents as Teachers Enhanced , builds upon the control curriculum by including culturally tailored nutrition and physical activity components specifically designed for the gestational and postnatal periods .
METHODS	We hypothesize that , as compared to the control arm , the experimental arm will be more effective in preventing inappropriate gestational weight gain , reducing postnatal weight retention , and decreasing infant obesity rates .
METHODS	We also will evaluate mother and child dietary and physical activity outcomes , breastfeeding initiation and continuation , and child feeding practices .
CONCLUSIONS	The Delta Healthy Sprouts Project tests a novel , combined approach to maternal weight management and childhood obesity prevention in pregnant women and their children at high risk for obesity and chronic disease .

###24974240
BACKGROUND	General practitioners/dermatologists may be aware of musculoskeletal symptoms in patients with psoriasis but may have difficulty accurately detecting psoriatic arthritis ( PsA ) .
OBJECTIVE	We sought to evaluate 3 PsA screening questionnaires-the Psoriasis and Arthritis Screening Questionnaire ( PASQ ) , Psoriasis Epidemiology Screening Tool ( PEST ) , and Toronto Psoriatic Arthritis Screen ( ToPAS ) - based on rheumatologist assessment in patients with psoriasis .
METHODS	Consecutive unselected patients with psoriasis , initially evaluated by dermatologists for plaque psoriasis , were randomized to receive 1 of 3 questionnaires .
METHODS	Patients were subsequently evaluated by rheumatologists to establish/exclude clinical PsA diagnosis .
METHODS	Using clinical PsA diagnosis as the standard for comparison , questionnaire accuracy was assessed by calculating sensitivity/specificity and positive/negative predictive values .
RESULTS	Of 949 patients with psoriasis evaluated by rheumatologists , 285 ( 30 % ) received a clinical diagnosis of PsA ( 95 % confidence interval 27 % -33 % ) .
RESULTS	Probable PsA was detected in 45.1 % , 43.0 % , and 42.9 % of patients using PASQ , PEST , and ToPAS , respectively .
RESULTS	Sensitivity ranged from 0.67 to 0.84 ; specificity , 0.64 to 0.75 ; positive predictive value , 0.43 to 0.60 ; and negative predictive value , 0.83 to 0.91 .
CONCLUSIONS	Not all patients completed all questionnaires ; lack of standardized diagnostic criteria introduced possible bias .
CONCLUSIONS	PASQ , PEST , and ToPAS are useful screening tools that can help dermatologists identifypatients without PsA and patients with possible PsA who may benefit from rheumatologist assessment .

###25470572
OBJECTIVE	The purpose of this study was to assess the time of onset and time course of efficacy over 12.0 hours of extended-release multilayer bead formulation of methylphenidate ( MPH-MLR ) compared with placebo in children 6-12 years of age with attention-deficit/hyperactivity disorder ( ADHD ) in a laboratory school setting .
METHODS	This randomized double-blind placebo-controlled study included children 6-12 years of age with ADHD .
METHODS	Enrolled children went through four study phases : 1 ) Screening period ( 4 weeks ) and a 2 day medication washout period ; 2 ) open-label period with dose initiation of MPH-MLR 15mg daily and individual dose optimization treatment period ( 2-4 weeks ) ; 3 ) double-blind crossover period in which participants were randomized to sequences ( 1 week each ) of placebo and the optimized MPH-MLR dose given daily ; and 4 ) follow-up safety call .
METHODS	Analog classroom time course evaluations were performed at the end of each double-blind week .
METHODS	The primary efficacy end-point was the mean of the on-treatment/postdose Swanson , Kotkin , Agler , M-Flynn , and Pelham ( SKAMP ) - Total scores over time points collected 1.0-12 .0 hours after dosing .
METHODS	End-points were evaluated using a mixed-effects analysis of covariance .
RESULTS	The evaluable population included 20 participants .
RESULTS	The least-squares mean postdose SKAMP-Total score was higher for placebo than for MPH-MLR ( 2.18 vs. 1.32 , respectively ; p = 0.0001 ) , indicating fewer symptoms with MPH-MLR therapy than with placebo .
RESULTS	No difference in SKAMP-Total score between participants who received sequence 1 or sequence 2 was noted .
RESULTS	From each of hours 1.0-12 .0 , least-squares mean SKAMP-Total score was significantly lower for those receiving MPH-MLR than for those receiving placebo ( p0 .0261 ) .
RESULTS	Neither serious adverse events nor new or unexpected safety findings were noted during the study .
CONCLUSIONS	MPH-MLR showed a significant decrease in SKAMP scores compared with placebo in children with ADHD 6-12 years of age , indicating a decrease in ADHD symptoms .
CONCLUSIONS	The estimated onset was observed within 1.0 hour , and duration was measured to 12.0 hours postdose .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01269463 .

###24246434
OBJECTIVE	Examine the short-term ( acute ) effects of methylphenidate ( MPH ) on math performance in children with attention-deficit hyperactivity disorder ( ADHD ) and what factors predict improvement in math performance .
METHODS	One hundred ninety-eight children with ADHD participated in a double-blind , placebo-controlled , randomized crossover MPH trial .
METHODS	Math response to MPH was determined through administration of math problems adjusted to their academic level during the Restricted Academic Situation Scale ( RASS ) .
METHODS	Student t tests were conducted to assess change in math performance with psychostimulants .
METHODS	Correlation between change on the RASS and change on the math performance was also examined .
METHODS	Linear regression was performed to determine predictor variables .
RESULTS	Children with ADHD improved significantly in their math with MPH ( P < 0.001 ) .
RESULTS	The degree of improvement on the RASS ( which evaluates motor activity and orientation to task ) and on math performance on MPH was highly correlated .
RESULTS	A child 's age at baseline and Wechsler Individual Achievement Test ( WIAT ) - Numerical Operations standard scores at baseline accounted for 15 % of variances for acute math improvement .
CONCLUSIONS	MPH improves acute math performance in children with ADHD .
CONCLUSIONS	Younger children with lower math scores ( as assessed by the WIAT ) improved most on math scores when given psychostimulants .
BACKGROUND	NCT00483106 .

###24328907
BACKGROUND	Atopic dermatitis ( AD ) is an inflammatory skin disease arising as a result of immune system and skin barrier defects .
BACKGROUND	Topical corticosteroids are safe and effective treatments for AD , when used in short courses .
BACKGROUND	Prolonged use is associated with skin barrier damage .
BACKGROUND	Topical calcineurin inhibitors are alternative immune-modulating treatments for AD purported to have no negative effects on the skin barrier .
OBJECTIVE	To compare the effects of betamethasone valerate 01 % cream ( BMVc ) and tacrolimus 01 % ointment ( TACo ) on the skin barrier .
METHODS	Twenty volunteers with quiescent AD ( no active signs for 6months ) participated in a randomized observer-blind study , wherein BMVc was applied to one forearm and TACo to the other , twice daily for 4weeks .
METHODS	The biophysical/biological properties of the stratum corneum were assessed before and after treatment .
METHODS	Nine volunteers with active disease and 10 with healthy skin were assessed at untreated sites .
RESULTS	BMVc significantly reduced skin barrier function , integrity and cohesion , and the levels of pyrrolidone carboxylic acid ( PCA ) and urocanic acid ( UCA ) towards the subclinical barrier defect observed in patients with AD ( nonlesional sites ) .
RESULTS	TACo preserved skin barrier function , integrity , cohesion and PCA and UCA levels , while significantly increasing skin hydration to levels comparable with healthy skin .
RESULTS	Both treatments reduced skin surface pH and trypsin-like protease activity , with TACo doing so to a significantly greater degree .
CONCLUSIONS	In quiescent AD , 4weeks of BMVc treatment adversely affected the biophysical properties of the skin and reduced the levels of natural moisturizing factor , whereas TACo improved the condition of the skin barrier .

###24952387
BACKGROUND	Mental and physical fatigue while at work is common among emergency medical services ( EMS ) shift workers .
BACKGROUND	Extended shifts ( for example 24 hours ) and excessive amounts of overtime work increase the likelihood of negative safety outcomes and pose a challenge for EMS fatigue-risk management .
BACKGROUND	Text message-based interventions are a potentially high-impact , low-cost platform for sleep and fatigue assessment and distributing information to workers at risk of negative safety outcomes related to sleep behaviors and fatigue .
METHODS	We will conduct a pilot randomized trial with a convenience sample of adult EMS workers recruited from across the United States using a single study website .
METHODS	Participants will be allocated to one of two possible arms for a 90-day study period .
METHODS	The intervention arm will involve text message assessments of sleepiness , fatigue , and difficulty with concentration at the beginning , during , and end of scheduled shifts .
METHODS	Intervention subjects reporting high levels of sleepiness or fatigue will receive one of four randomly selected intervention messages promoting behavior change during shiftwork .
METHODS	Control subjects will receive assessment only text messages .
METHODS	We aim to determine the performance characteristics of a text messaging tool for the delivery of a sleep and fatigue intervention .
METHODS	We seek to determine if a text messaging program with tailored intervention messages is effective at reducing perceived sleepiness and/or fatigue among emergency medicine clinician shift workers .
METHODS	Additional aims include testing whether a theory-based behavioral intervention , delivered by text message , changes ` alertness behaviors ' .
CONCLUSIONS	The SleepTrackTXT pilot trial could provide evidence of compliance and effectiveness that would support rapid widespread expansion in one of two forms : 1 ) a stand-alone program in the form of a tailored/individualized sleep monitoring and fatigue reduction support service for EMS workers ; or 2 ) an add-on to a multi-component fatigue risk management program led and maintained by employers or by safety and risk management services .
BACKGROUND	Clinicaltrials.gov NCT02063737 , Registered on 10 January 2014 .

###24472253
OBJECTIVE	This study reports 12-month follow-up data from a randomized controlled trial of preschool-based social communication treatment for young children with autism .
METHODS	A total of 61 children ( 48 males ) with autism , 29 to 60 months of age , had earlier been randomized either to 8 weeks of preschool-based social communication treatment in addition to standard preschool program ( n = 34 ) or to standard preschool program only ( n = 27 ) .
METHODS	Significant short-term effects on targeted social communication skills have previously been published .
METHODS	Long-term gains in social communication , language and global social functioning and communication were assessed from video-taped preschool teacher-child and mother-child interactions , Early Social Communication Scales , Reynell Developmental Language Scale , and Social Communication Questionnaire .
RESULTS	Compared with those in the control group , the treated children achieved significantly larger improvements in joint attention and joint engagement from baseline to 12-month follow-up .
RESULTS	However , no effects were detected on language and global ratings of social functioning and communication .
RESULTS	The treatment effect on child initiation of joint attention increased with increasing level of sociability at baseline , whereas nonverbal IQ and expressive language had no moderating effect .
CONCLUSIONS	This study is the first to show that , similar to specialist-delivered treatment , preschool-based treatment may produce small but possibly clinically important long-term changes in social communication in young children with autism .
CONCLUSIONS	The treatment did not affect language and global ratings of social functioning and communication .
CONCLUSIONS	More studies are needed to better understand whether treatment effects may be improved by increasing the intensity and duration of the treatment .
CONCLUSIONS	Clinical trial registration information -- Joint Attention Intervention and Young Children With Autism ; http://clinicaltrials.gov/; NCT00378157 .

###25602358
OBJECTIVE	Protocolized sedation improves clinical outcomes in critically ill adults , but its effect in children is unknown .
OBJECTIVE	To determine whether critically ill children managed with a nurse-implemented , goal-directed sedation protocol experience fewer days of mechanical ventilation than patients receiving usual care .
METHODS	Cluster randomized trial conducted in 31 US pediatric intensive care units ( PICUs ) .
METHODS	A total of 2449 children ( mean age , 4.7 years ; range , 2 weeks to 17 years ) mechanically ventilated for acute respiratory failure were enrolled in 2009-2013 and followed up until 72 hours after opioids were discontinued , 28 days , or hospital discharge .
METHODS	Intervention PICUs ( 17 sites ; n = 1225 patients ) used a protocol that included targeted sedation , arousal assessments , extubation readiness testing , sedation adjustment every 8 hours , and sedation weaning .
METHODS	Control PICUs ( 14 sites ; n = 1224 patients ) managed sedation per usual care .
METHODS	The primary outcome was duration of mechanical ventilation .
METHODS	Secondary outcomes included time to recovery from acute respiratory failure , duration of weaning from mechanical ventilation , neurological testing , PICU and hospital lengths of stay , in-hospital mortality , sedation-related adverse events , measures of sedative exposure ( wakefulness , pain , and agitation ) , and occurrence of iatrogenic withdrawal .
RESULTS	Duration of mechanical ventilation was not different between the 2 groups ( intervention : median , 6.5 [ IQR , 4.1-11 .2 ] days ; control : median , 6.5 [ IQR , 3.7-12 .1 ] days ) .
RESULTS	Sedation-related adverse events including inadequate pain and sedation management , clinically significant iatrogenic withdrawal , and unplanned endotracheal tube/invasive line removal were not significantly different between the 2 groups .
RESULTS	Intervention patients experienced more postextubation stridor ( 7 % vs 4 % ; P = .03 ) and fewer stage 2 or worse immobility-related pressure ulcers ( < 1 % vs 2 % ; P = .001 ) .
RESULTS	In exploratory analyses , intervention patients had fewer days of opioid administration ( median , 9 [ IQR , 5-15 ] days vs 10 [ IQR , 4-21 ] days ; P = .01 ) , were exposed to fewer sedative classes ( median , 2 [ IQR , 2-3 ] classes vs 3 [ IQR , 2-4 ] classes ; P < .001 ) , and were more often awake and calm while intubated ( median , 86 % [ IQR , 67 % -100 % ] of days vs 75 % [ IQR , 50 % -100 % ] of days ; P = .004 ) than control patients , respectively ; however , intervention patients had more days with any report of a pain score 4 ( median , 50 % [ IQR , 27 % -67 % ] of days vs 23 % [ IQR , 0 % -46 % ] of days ; P < .001 ) and any report of agitation ( median , 60 % [ IQR , 33 % -80 % ] vs 40 % [ IQR , 13 % -67 % ] ; P = .003 ) , respectively .
CONCLUSIONS	Among children undergoing mechanical ventilation for acute respiratory failure , the use of a sedation protocol compared with usual care did not reduce the duration of mechanical ventilation .
CONCLUSIONS	Exploratory analyses of secondary outcomes suggest a complex relationship among wakefulness , pain , and agitation .
BACKGROUND	clinicaltrials.gov Identifier : NCT00814099 .

###24477319
BACKGROUND	Pertrochanteric hip fractures occur in an elderly population and cause considerable morbidity and loss of functional ability as the fracture heals .
BACKGROUND	Recently , parathyroid hormone ( PTH ) , which is licensed for the treatment of osteoporosis , has been shown to potentially accelerate bone healing in animal and human studies .
BACKGROUND	If its administration could allow a faster functional recovery after pertrochanteric hip fracture , then a patient 's hospital stay may be reduced and rehabilitation could be potentially accelerated .
BACKGROUND	PTH can currently only be administered by subcutaneous injection .
BACKGROUND	The acceptability of this intervention is unknown in this elderly population .
BACKGROUND	The aim of this pilot study is to inform the design of a future powered study comparing the functional recovery after pertrochanteric hip fracture in patients undergoing standard care versus those who undergo administration of subcutaneous injection of PTH .
METHODS	The study is an open label , prospective , randomised , comparative pilot study with blinded outcomes assessment to establish feasibility of the trial design .
METHODS	Patients will be randomised to receive a 6-week course of PTH or usual treatment .
METHODS	Functional outcomes will be assessed at 6 weeks and 12 weeks .
METHODS	Blinded assessment will be used to minimise the effect of bias of an open label study design .
METHODS	A nested qualitative study will investigate the patient experience of , and expectations following , hip fracture and the patient important aspects of recovery compared with the outcome measures proposed .
RESULTS	Results will be analysed to establish the potential recruitment , compliance and retention rates using 95 % CIs , and trial outcomes quoted with SDs and 95 % CIs for the effect size .
BACKGROUND	The study has been approved by the South West 2 Research Ethics committee ( reference 10/H0206/34 ) .
BACKGROUND	The findings of this study will be disseminated to the medical community via presentations to orthopaedic , orthogeriatric and osteoporosis societies , and their relevant specialist journals .
BACKGROUND	ISRCTN Register reference number : ISRCTN03362357 .
BACKGROUND	Eudract Number : 2010-020081-22 .

###24888316
BACKGROUND	Myrtle ( Myrtus communis L. ) has been used in the Iranian Traditional Medicine as a treatment for abnormal uterine bleeding-menometrorrhagia .
BACKGROUND	The main aim of this study is to evaluate the effect of myrtle fruit syrup on abnormal uterine bleeding-menometrorrhagia .
METHODS	A randomized , double-blind , placebo-controlled pilot study was conducted on 30 women suffering from abnormal uterine bleeding-menometrorrhagia .
METHODS	Treatment comprised of giving 15ml oral myrtle syrup daily ( 5ml three times a day ) for 7days starting from the onset of bleeding .
METHODS	The myrtle syrup along with placebo was repeated for 3 consecutive menstrual periods .
METHODS	Menstrual duration and number of used pads were recorded by the Pictorial Blood loss Assessment Chart at the end of each menstrual period .
METHODS	The quality of life was also evaluated using the menorrhagia questionnaire .
RESULTS	The mean number of bleeding days significantly declined from 10.62.7 days to 8.21.9 days after 3months treatment with the syrup ( p = 0.01 ) and consequently the participants in the intervention group used fewer pads after 3months ( 16.410.7 ) compared with the number of pads used at the beginning of the treatment ( 22.712.0 , p = 0.01 ) .
RESULTS	Bleeding days and number of pads used by the participants in the placebo group did not change significantly .
RESULTS	Also significant changes of quality of life scores were observed in the intervention group after 3months compared to the baseline .
CONCLUSIONS	Myrtle syrup is introduced as a potential remedy for abnormal uterine bleeding-menometrorrhagia .

###24321717
OBJECTIVE	Despite positive effects of incretins on insulin secretion , little is known about the effect of exercise on these hormones .
OBJECTIVE	Metformin can affect incretin concentrations and is prescribed to a large proportion of people with diabetes .
OBJECTIVE	We , therefore , examined the effects of aerobic exercise and/or metformin on incretin hormones .
METHODS	Ten participants with type 2 diabetes were recruited for this randomized crossover study .
METHODS	Metformin or placebo was given for 28 days , followed by the alternate treatment for 28 days .
METHODS	On the last 2 days of each condition , participants were assessed during a non-exercise day and a subsequent exercise day .
METHODS	Aerobic exercise took place in the morning and blood samples were taken in the subsequent hours ( before and after lunch ) .
RESULTS	Aerobic exercise did not increase total plasma glucagon-like peptide-1 ( GLP-1 ) or glucose-dependent insulinotropic polypeptide ( GIP ) in the pre - or post-lunch periods ( all p > 0.1 ) .
RESULTS	GLP-1 was higher in the pre-lunch ( p = 0.016 ) and post-lunch ( p = 0.018 ) periods of the metformin conditions compared with the placebo .
RESULTS	Total plasma GIP was higher in the pre-lunch period ( p = 0.05 ) , but not in the post-lunch period ( p = 0.95 ) , with metformin compared with placebo .
CONCLUSIONS	In contrast to our hypothesis , aerobic exercise did not acutely increase total GLP-1 and GIP levels in patients with type 2 diabetes .
CONCLUSIONS	Metformin , independent of exercise , significantly increased total plasma GLP-1 and GIP concentrations in these patients .

###25802953
OBJECTIVE	The aim of this study was to investigate the effects of two exercise programs on lower extremity function in patients with juvenile idiopathic arthritis .
METHODS	Thirty patients with juvenile idiopathic arthritis participated in this study .
METHODS	Pain , passive range of motion , muscle strength , balance , and functional abilities were assessed with the Numeric Rating Scale , goniometer , handheld dynamometer , Flamingo Balance Test , Functional Reach Test , 10-meter walking test , 10-stair climbing test , and Childhood Health Assessment Questionnaire .
METHODS	Participants were randomly assigned to the strengthening exercise group ( group 1 , n = 15 ) or the proprioceptive-balance exercise group ( group 2 , n = 15 ) .
RESULTS	Intragroup analysis showed statistically significant improvements in all outcome measures except muscle strength in the hip and ankle after strengthening exercises in group 1 .
RESULTS	However , statistically significant improvements were found in all outcome measures after the proprioceptive-balance exercises in group 2 .
RESULTS	Intergroup analysis showed statistically significant improvement in all outcome measures in group 2 except for the Numeric Rating Scale , Childhood Health Assessment Questionnaire , and passive range of motion scores and hip extension and knee flexion muscle strengths .
CONCLUSIONS	This study demonstrates that exercise treatment significantly improves musculoskeletal symptoms in patients with juvenile idiopathic arthritis .
CONCLUSIONS	However , balance-proprioceptive exercises prove to be effective more than strengthening exercises for improving lower extremity function such as walking , climbing stairs , and balance in patients with juvenile idiopathic arthritis .

###24368034
OBJECTIVE	A high-frequency steady-state visual evoked potential ( SSVEP ) has been suggested for the reduction of eye fatigue for SSVEP-based brain-computer interfaces ( BCIs ) .
OBJECTIVE	However , the poor performance of high-frequency SSVEP requires a novel stimulus of better performance even with low eye fatigue .
OBJECTIVE	As an alternative to the high-frequency SSVEP , we explore the SSVEP response to an amplitude-modulated stimulus ( AM-SSVEP ) to verify its availability for brain-computer interfaces ( BCIs ) .
METHODS	An amplitude-modulated stimulus was generated as the product of two sine waves at a carrier frequency ( fc ) and a modulating frequency ( fm ) .
METHODS	The carrier frequency was higher than 40 Hz to reduce eye fatigue , and the modulating frequency ranged around the - band ( 9-12 Hz ) to utilize low-frequency harmonic information .
METHODS	Four targets were used in combinations of three different modulating frequencies and two different carrier frequencies in the offline experiment , and two additional targets were added with one additional modulating and one carrier frequency in online experiments .
RESULTS	In the AM-SSVEP spectra , seven harmonic components were identified at 2fc , 2fm , fcfm , fc3fm , and 2fc-4fm .
RESULTS	Using an optimized combination of the harmonic frequencies , online experiments demonstrated that the accuracy of the AM-SSVEP was equivalent to that of the low-frequency SSVEP .
RESULTS	Furthermore , subject evaluation indicated that an AM stimulus caused lower eye fatigue and less sensing of flickering than a low-frequency stimulus , in a manner similar to a high-frequency stimulus .
CONCLUSIONS	The actual stimulus frequencies of AM-SSVEPs are in the high-frequency band , resulting in reduced eye fatigue .
CONCLUSIONS	Furthermore , AM-SSVEPs can utilize both fundamental stimulus frequencies and non-integer harmonic frequencies including low frequencies for SSVEP recognition .
CONCLUSIONS	The feasibility of AM-SSVEP with high BCI performance and low eye fatigue was confirmed through offline and online experiments .
CONCLUSIONS	AM-SSVEPs combine the advantages of both low - and high-frequency SSVEPs -- high power and low eye fatigue , respectively .
CONCLUSIONS	AM-SSVEP-based BCI systems exploit these advantages , making them promising for application in practical BCI systems .

###24576515
BACKGROUND	The use of supplemental oxygen in the setting of suspected acute myocardial infarction ( AMI ) is recommended in international treatment guidelines and established in prehospital and hospital clinical routine throughout the world .
BACKGROUND	However , to date there is no conclusive evidence from adequately designed and powered trials supporting this practice .
BACKGROUND	Existing data are conflicting and fail to clarify the role of supplemental oxygen in AMI .
METHODS	A total of 6,600 normoxemic ( oxygen saturation [ SpO2 ] 90 % ) patients with suspected AMI will be randomly assigned to either supplemental oxygen 6 L/min delivered by Oxymask ( MedCore Sweden AB , Kista , Sweden ) for 6 to 12 hours in the treatment group or room air in the control group .
METHODS	Patient inclusion and randomization will take place at first medical contact , either before hospital admission or at the emergency department .
METHODS	The Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies registry will be used for online randomization , allowing inclusion of a broad population of all-comers .
METHODS	Follow-up will be carried out in nationwide health registries and Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies .
METHODS	The primary objective is to evaluate whether oxygen reduces 1-year all-cause mortality .
METHODS	Secondary end points include 30-day mortality , major adverse cardiac events , and health economy .
METHODS	Prespecified subgroups include patients with confirmed AMI and certain risk groups .
METHODS	In a 3-month pilot study , the study concept was found to be safe and feasible .
CONCLUSIONS	The need to clarify the uncertainty of the role of supplemental oxygen therapy in the setting of suspected AMI is urgent .
CONCLUSIONS	The DETO2X-AMI trial is designed and powered to address this important issue and may have a direct impact on future recommendations .

###25127885
BACKGROUND	Despite the intensive global efforts to control intestinal parasitic infections , the prevalence of soil-transmitted helminth ( STH ) infections is still very high in many developing countries particularly among children in rural areas .
METHODS	A randomized , double-blind , placebo-controlled trial was conducted on 250 Aboriginal schoolchildren in Malaysia to investigate the effects of a single high-dose of vitamin A supplementation ( 200,000 IU ) on STH reinfection .
METHODS	The effect of the supplement was assessed at 3 and 6 months after receiving interventions ; after a complete 3-day deworming course of 400 mg/daily of albendazole tablets .
RESULTS	Almost all children ( 98.6 % ) were infected with at least one STH species .
RESULTS	The overall prevalence of ascariasis , trichuriasis and hookworm infection was 67.8 % , 95.5 % and 13.4 % , respectively .
RESULTS	Reinfection rates of Ascaris , Trichuris and hookworm were high ; at 6 months , assessment reached 80 % of the prevalence reported before treatment .
RESULTS	There were no significant differences in the reinfection rates and intensities of STH between vitamin A supplemented-children and those who received placebo at 3 and 6 months ( p > 0.05 ) .
CONCLUSIONS	Vitamin A supplementation showed no protective effect against STH reinfection and this could be due to the high endemicity of STH in this community .
CONCLUSIONS	Long-term interventions to reduce poverty will help significantly in reducing this continuing problem and there is no doubt that reducing intestinal parasitic infection would have a positive impact on the health , nutrition and education of these children .
BACKGROUND	This trial was registered at clinicaltrials.gov as NCT00936091 .

###24800384
BACKGROUND	Diet and lifestyle modification is commonly used in constipation management .
BACKGROUND	As there is a dearth of studies on this topic in Malaysia , we aim to elucidate the relations between stool patterns , dietary intake and physical activity levels among adults with functional constipation .
METHODS	From a database collected via surveys at public events , a convenience sample of 100 adults diagnosed with Rome II-defined functional constipation was enrolled in this cross-sectional study .
METHODS	After severity assessment using the Chinese Constipation Questionnaire , subjects completed 2-week bowel movement diaries to determine stool frequency , consistency and output .
METHODS	Dietary intake and physical activity levels were assessed twice using three-day 24-hour diet recalls and International Physical Activity Questionnaire , respectively .
METHODS	Ninety subjects who completed the study were included in the analysis .
RESULTS	Mean weekly stool frequency was 3.9 + / - 1.9 times , consistency score was 2.6 + / - 0.6 ( range 1.0-4 .0 ) , output was 11.0 + / - 6.3 balls ( 40 mm diameter ) and severity score was 10.3 + / - 3.3 ( range 5.0-22 .0 ) .
RESULTS	Mean daily dietary intakes were : energy 1,719 + / - 427kcal , dietary fibre 15.0 + / - 4.9 g and fluid 2.5 + / - 0.8 L.
RESULTS	The majority of subjects were physically inactive .
RESULTS	Stool frequency and output were positively associated with dietary fibre ( r ( s ) = 0.278 , P < 0.01 ; r ( s ) = 0.226 , P < 0.05 ) and fluid intake ( r ( s ) = 0.257 , P < 0.05 ; OR = 3.571 , 95 % CI [ 1.202-10 .609 ] ) .
RESULTS	Constipation severity was associated with higher physical activity levels ( OR = 2.467 , 95 % CI [ 1.054-5 .777 ] ) .
CONCLUSIONS	Insufficient intake of dietary fibre and fluid are associated with aggravated constipation symptoms .
CONCLUSIONS	Further studies are necessary to confirm usefulness of dietary intervention in treatment of constipation as dietary factors alone may not influence overall severity and stool consistency , an integral element of constipation .

###25414318
OBJECTIVE	Patients with CKD have a high prevalence of cardiovascular disease associated with or exacerbated by inactivity .
OBJECTIVE	This randomized , controlled study investigated whether a renal rehabilitation exercise program for patients with stages 3 or 4 CKD would improve their physical function and quality of life .
METHODS	In total , 119 adults with CKD stages 3 and 4 were randomized , and 107 of these patients proceeded to usual care or the renal rehabilitation exercise intervention consisting of usual care plus guided exercise two times per week for 12 weeks ( 24 sessions ) .
METHODS	Physical function was determined by three well established performance-based tests : 6-minute walk test , sit-to-stand test , and gait-speed test .
METHODS	Health-related quality of life was assessed by the RAND 36-Item Short Form Health Survey .
RESULTS	At baseline , no differences in self-reported level of activity , 6-minute walk test , and sit-to-stand test scores were observed between the usual care ( n = 48 ) and renal rehabilitation exercise ( n = 59 ) groups , although baseline gait-speed test score was higher in the renal rehabilitation exercise group ( P < 0.001 ) .
RESULTS	At follow-up , the renal rehabilitation exercise group but not the usual care group showed significant improvements in the 6-minute walk test ( +210.4266.0 ft [ 19 % improvement ] versus -10219.9 ft ; P < 0.001 ) , the sit-to-stand test ( +26.927 % of age prediction [ 29 % improvement ] versus +0.712.1 % of age prediction ; P < 0.001 ) , and the RAND-36 physical measures of role functioning ( P < 0.01 ) , physical functioning ( P < 0.01 ) , energy/fatigue levels ( P = 0.01 ) , and general health ( P = 0.03 ) and mental measure of pain scale ( P = 0.04 ) .
RESULTS	The renal rehabilitation exercise regimen was generally well tolerated .
CONCLUSIONS	A 12-week/24-session renal rehabilitation exercise program improved physical capacity and quality of life in patients with CKD stages 3 and 4 .
CONCLUSIONS	Longer follow-up is needed to determine if these findings will translate into decreased mortality rates .

###25457927
OBJECTIVE	Youth in war-affected regions are at risk for poor psychological , social , and educational outcomes .
OBJECTIVE	Effective interventions are needed to improve mental health , social behavior , and school functioning .
OBJECTIVE	This randomized controlled trial tested the effectiveness of a 10-session cognitive-behavioral therapy ( CBT ) - based group mental health intervention for multisymptomatic war-affected youth ( aged 15-24 years ) in Sierra Leone .
METHODS	War-affected youth identified by elevated distress and impairment via community screening were randomized ( stratified by sex and age ) to the Youth Readiness Intervention ( YRI ) ( n = 222 ) or to a control condition ( n = 214 ) .
METHODS	After treatment , youth were again randomized and offered an education subsidy immediately ( n = 220 ) or waitlisted ( n = 216 ) .
METHODS	Emotion regulation , psychological distress , prosocial attitudes/behaviors , social support , functional impairment , and posttraumatic stress disorder ( PTSD ) symptoms were assessed at pre - and postintervention andat 6-month follow-up .
METHODS	For youth in school , enrollment , attendance , and classroom performance were assessed after 8 months .
METHODS	Linear mixed-effects regressions evaluated outcomes .
RESULTS	The YRI showed significant postintervention effects on emotion regulation , prosocial attitudes/behaviors , social support , and reduced functional impairment , and significant follow-up effects on school enrollment , school attendance , and classroom behavior .
RESULTS	In contrast , education subsidy was associated with better attendance but had no effect on mental health or functioning , school retention , or classroom behavior .
RESULTS	Interactions between education subsidy and YRI were not significant .
CONCLUSIONS	YRI produced acute improvements in mental health and functioning as well as longer-term effects on school engagement andbehavior , suggesting potential to prepare war-affected youth for educational and otheropportunities .
CONCLUSIONS	Clinical trial registration information-Trial of the Youth Readiness Intervention ( YRI ) ; http://clinicaltrials.gov; NCT01684488 .

###24919694
BACKGROUND	Images depicting morbidly obese models [ i.e. body mass index ( BMI ) > 40 ] often accompany media articles about the health risks of being overweight ( i.e. BMI 25-30 ) .
BACKGROUND	Little is known about the effect of this mismatch on people 's understanding of risk , and perceptions of message relevance .
METHODS	In total , 563 participants ( 291 overweight/obese and 272 healthy weight ) were randomly allocated to read a health message about the risk of heart disease posed by being overweight , presented alongside ( i ) a photo of an overweight model , ( ii ) a morbidly obese model or ( iii ) no photo .
METHODS	Between-group differences in the primary outcomes of message relevance , and the body size perceived to be ` at risk ' , were assessed , and the potential moderating effects of motivation , weight concern and existing risk knowledge explored .
RESULTS	Overweight and obese participants in the exaggerated ( morbidly obese ) image condition interpreted health risks to relate to a larger body size than those who saw no image ( F ( 2 , 290 ) = 4.06 , P = 0.02 ) .
RESULTS	There was no experimental effect on perceived personal relevance ( F ( 2 , 290 ) = 0.25 , P = 0.38 ) .
RESULTS	No significant moderation effects were detected , and there was no effect of study condition in healthy weight participants for either outcome .
CONCLUSIONS	The findings suggest that the use of morbidly obese models in messages regarding the health risks of being overweight may undermine the impact of these messages among those who they most aim to reach ; the reader may perceive a reduced risk of being ` only ' overweight , and that a higher weight is needed for the negative effects of excess weight to occur .

###25536713
OBJECTIVE	To evaluate the anti-spasticity effects of anodal transcranial direct current stimulation ( tDCS ) in individuals with spastic cerebral palsy ( CP ) .
METHODS	Forty-six children and adolescents with cerebral palsy were randomly assigned to either active ( 1 mA anodal ) or sham ( placebo ) tDCS over the left primary motor cortex ( Ml ) on five consecutive days .
METHODS	Both group also received routine physical therapy .
METHODS	Measures of spasticity and passive range of motion ( PROM ) were administered before treatment , immediately after treatment , and at 24 - and 48-hours follow-up .
RESULTS	Participants assigned to active tDCS treatment evidenced significantly more pre - to immediately post-treatment reductions in spasticity than participants assigned to the sham ( p = 0.004 , p < O. 001l , andp = 0.004 for shoulder wrist , and fingers respectively ) and these improvement in spasticity maintainedfor at least 48 hours for wrist joints ( p = 0.023 ) .
RESULTS	There was only one participant in the active tDCS condition developed erythematous rash .
RESULTS	However , all participants tolerated the tDCS well without any serious adverse events .
CONCLUSIONS	Anodal tDCS appeared to reduce CP-relatedspasticity ( but not PROM ) in the short term .
CONCLUSIONS	Researches examine the long term benefits of this intervention on spasticity are warranted .

###25719253
OBJECTIVE	The aim of this study was to evaluate the effect of dietary omega-3 fatty acid ( O3FA ) supplementation on dry eye symptoms , tear film tests , and conjunctival impression cytology in patients with contact lens wear-associated dry eye .
METHODS	In this randomized , double-blind , multicentric trial , contact lens wearers ( n = 496 ) were randomized to receive either O3FAs or placebo capsules ( corn oil ) twice daily for 6 months .
METHODS	Subjects underwent examinations at baseline , 3 months , and 6 months .
METHODS	At each visit , a questionnaire of dry eye symptoms and lens wear comfort was administered .
METHODS	Subjects further underwent measurement of tear film break-up time ( TBUT ) and a Schirmer test .
METHODS	Conjunctival impression cytology was performed by the transfer method .
METHODS	Improvement in symptoms and lens wear comfort were primary outcome measures .
METHODS	Changes from baseline in TBUT , Schirmer , and Nelson grade at 6 months were secondary outcome measures .
RESULTS	The mean improvement in symptom score in the O3FA group was 4.7 2 ( 2.0 ) as compared with 0.5 2 ( 0.9 ) in the placebo group ( P < 0.0001 ) .
RESULTS	Lens wear comfort levels improved significantly ( P < 0.0001 ) from baseline .
RESULTS	There was a significant increase in TBUT [ 3.3 2 ( 1.5 ) ] and Nelson grade [ 0.7 2 ( 0.6 ) ] in the O3FA group ( P < 0.0001 ) as compared with 0.3 2 ( 0.6 ) and 0.1 2 ( 0.4 ) in the placebo group ( P = 0.164 and 0.094 , respectively ) .
RESULTS	However , the magnitude of increase in Schirmer score [ 2.0 2 ( 1.5 ) ] was relatively small ( P = 0.08 ) .
CONCLUSIONS	The results of this study point toward benefits of orally administered O3FAs in alleviating dry eye symptoms , improving lens wear comfort , and cytological changes in contact lens wearers .

###24792139
OBJECTIVE	To evaluate and compare the effects of 2 manual therapy interventions on cervical spine range of motion ( ROM ) , head repositioning accuracy , and balance in patients with chronic cervicogenic dizziness .
METHODS	Randomized controlled trial with 12-week follow-up using blinded outcome assessment .
METHODS	University School of Health Sciences .
METHODS	Participants ( N = 86 ; mean age SD , 62.0 12.7 y ; 50 % women ) with chronic cervicogenic dizziness .
METHODS	Participants were randomly assigned to 1 of 3 groups : sustained natural apophyseal glides ( SNAGs ) with self-SNAG exercises , passive joint mobilization ( PJM ) with ROM exercises , or a placebo .
METHODS	Participants each received 2 to 6 treatments over 6 weeks .
METHODS	Cervical ROM , head repositioning accuracy , and balance .
RESULTS	SNAG therapy resulted in improved ( P .05 ) cervical spine ROM in all 6 physiological cervical spine movement directions immediately posttreatment and at 12 weeks .
RESULTS	Treatment with PJM resulted in improvement in 1 of the 6 cervical movement directions posttreatment and 1 movement direction at 12 weeks .
RESULTS	There was a greater improvement ( P < .01 ) after SNAGs than PJM in extension ( mean difference , -7.5 ; 95 % confidence interval [ CI ] , -13 to -2.0 ) and right rotation ( mean difference , -6.8 ; 95 % CI , -11.5 to -2.1 ) posttreatment .
RESULTS	Manual therapy had no effect on balance or head repositioning accuracy .
CONCLUSIONS	SNAG treatment improved cervical ROM , and the effects were maintained for 12 weeks after treatment .
CONCLUSIONS	PJM had very limited impact on cervical ROM .
CONCLUSIONS	There was no conclusive effect of SNAGs or PJMs on joint repositioning accuracy or balance in people with cervicogenic dizziness .

###25586727
BACKGROUND	In early postpartum haemorrhage ( PPH ) , a low concentration of fibrinogen is associated with excessive subsequent bleeding and blood transfusion .
BACKGROUND	We hypothesized that pre-emptive treatment with fibrinogen concentrate reduces the need for red blood cell ( RBC ) transfusion in patients with PPH .
METHODS	In this investigator-initiated , multicentre , double-blinded , parallel randomized controlled trial , we assigned subjects with severe PPH to a single dose of fibrinogen concentrate or placebo ( saline ) .
METHODS	A dose of 2 g or equivalent was given to all subjects independent of body weight and the fibrinogen concentration at inclusion .
METHODS	The primary outcome was RBC transfusion up to 6 weeks postpartum .
METHODS	Secondary outcomes were total blood loss , total amount of blood transfused , occurrence of rebleeding , haemoglobin < 58 g litre ( -1 ) , RBC transfusion within 4 h , 24 h , and 7 days , and as a composite outcome of ` severe PPH ' , defined as a decrease in haemoglobin of > 40 g litre ( -1 ) , transfusion of at least 4 units of RBCs , haemostatic intervention ( angiographic embolization , surgical arterial ligation , or hysterectomy ) , or maternal death .
RESULTS	Of the 249 randomized subjects , 123 of 124 in the fibrinogen group and 121 of 125 in the placebo group were included in the intention-to-treat analysis .
RESULTS	At inclusion the subjects had severe PPH , with a mean blood loss of 1459 ( sd 476 ) ml and a mean fibrinogen concentration of 4.5 ( sd 1.2 ) g litre ( -1 ) .
RESULTS	The intervention group received a mean dose of 26 mg kg ( -1 ) fibrinogen concentrate , thereby significantly increasing fibrinogen concentration compared with placebo by 0.40 g litre ( -1 ) ( 95 % confidence interval , 0.15-0 .65 ; P = 0.002 ) .
RESULTS	Postpartum blood transfusion occurred in 25 ( 20 % ) of the fibrinogen group and 26 ( 22 % ) of the placebo group ( relative risk , 0.95 ; 95 % confidence interval , 0.58-1 .54 ; P = 0.88 ) .
RESULTS	We found no difference in any predefined secondary outcomes , per-protocol analyses , or adjusted analyses .
RESULTS	No thromboembolic events were detected .
CONCLUSIONS	We found no evidence for the use of 2 g fibrinogen concentrate as pre-emptive treatment for severe PPH in patients with normofibrinogenaemia .
BACKGROUND	ClinicalTrials.gov : http://clinicaltrials.gov/show/NCT01359878 .
BACKGROUND	Published protocol : http://www.trialsjournal.com/content/pdf/1745-6215-13-110.pdf .

###24649935
OBJECTIVE	The therapeutic outcomes of low-level laser therapy ( LLLT ) on closed bone fractures ( CBFs ) in the wrist and hand were investigated in this controlled study .
BACKGROUND	Animal research has confirmed that LLLT increases osteocyte quantity ; however , little research has been conducted to determine the effect of LLLT on the treatment of human bone fractures .
METHODS	In this study , the therapeutic outcomes of administering 830nm LLLT to treat CBFs in the wrist or hand were examined .
METHODS	Fifty patients with CBFs in the wrist and hand , who had not received surgical treatment , were recruited and randomly assigned to two groups .
METHODS	The laser group underwent a treatment program in which 830nm LLLT ( average power 60mW , peak power 8W , 10Hz , 600sec , and 9.7 J/cm ( 2 ) per fracture site ) was administered five times per week for 2 weeks .
METHODS	Participants in a placebo group received sham laser treatment .
METHODS	The pain , functional disability , grip strength , and radiographic parameters of the participants were evaluated before and after treatment and at a 2-week follow-up .
RESULTS	After treatment and at the follow-up , the laser group exhibited significant changes in all of the parameters compared with the baseline ( p < 0.05 ) .
RESULTS	The results of comparing the two groups after treatment and at the follow-up indicated significant between-group differences among all of the parameters ( p < 0.05 ) .
CONCLUSIONS	LLLT can relieve pain and improve the healing process of CBFs in the human wrist and hand .

###24363363
BACKGROUND	Oral antibiotics use in infants in developing countries is challenging because liquid formulations are often unavailable .
BACKGROUND	However , dissolving solid formulation of drugs in water poses a risk of gastrointestinal infection .
BACKGROUND	Although mother 's milk may be a potential vehicle , no evidence exists to indicate that antibiotics dissolved in human milk are bioequivalent to those dissolved in water .
BACKGROUND	Therefore , we compared pharmacokinetic parameters of an orally administered antibiotic , amoxicillin , dissolved in human milk , to those of water-dissolved amoxicillin .
METHODS	A pharmacokinetic study was conducted in 16 healthy adult volunteers in a randomised crossover design .
METHODS	Marketed amoxicillin powder for suspension was dissolved in either human milk or water at a final concentration of 50 mg/mL , and 10 mL was given orally in a fasting state .
METHODS	Timed blood samples were obtained and plasma amoxicillin was quantified using liquid chromatography-mass spectrometry .
RESULTS	Results showed that pharmacokinetic parameters , including area-under-the-curve , Cmax and half-life of the water-based and milk-based amoxicillin administration were not significantly different .
RESULTS	90 % CIs of the ratios of these parameters in concomitant breast milk administration to those of water were within 89 % and 116 % , suggesting they are bioequivalent ( defined as a range between 80 % and 125 % ) .
CONCLUSIONS	We conclude that oral administration of amoxicillin dissolved in human milk at 50 mg/mL results in pharmacokinetics profiles comparable to amoxicillin dissolved in water .
CONCLUSIONS	Pharmaceutical interactions between amoxicillin and breast milk are unlikely , suggesting no need to modify dosing schedules .

###26078237
BACKGROUND	Patients with stroke suffer from nutrition impairments and often rely on enteral nutrition ( EN ) , which is associated with respiratory complications such as regurgitation and aspiration .
OBJECTIVE	To evaluate the incidence of regurgitation and aspiration in patients with severe stroke infused with different volumes of EN .
METHODS	A randomized controlled trial was conducted on 210 patients with severe stroke undergoing EN therapy .
METHODS	Patients were randomly assigned into two groups .
METHODS	Subjects in the treatment group received EN with an initial rate defined according to the total volume and the infusion rate was adjusted based on gastric residual volume ( GRV ) assessed every 4 hours .
METHODS	Subjects of the control group received EN without monitoring the GRV and reached the target infusion volume within 72 hours .
METHODS	The incidence of reflux and aspiration was recorded .
RESULTS	The incidences of regurgitation and aspiration were significantly lower in treatment group ( 6.3 % and 7.9 % , respectively ) than control group ( 18.8 % and 17.5 % , respectively ) .
RESULTS	In the treatment group , 1 patient developed regurgitation while 2 developed aspiration when EN was 500 mL .
RESULTS	When EN increased to 1000 mL , 2 patients developed regurgitation and 2 developed aspiration , and 5 patients developed regurgitation and 6 had aspiration when EN was 1500 mL .
RESULTS	There was no significant difference in the risk of reflux and aspiration when total volume of EN increased from 500 to 1500 mL .
CONCLUSIONS	During EN therapy for patients with stroke , using feeding pump with a continuous infusion for 20 hours and adjusting infusion rate based on GRV could reduce the incidence of respiratory complications .

###24464687
OBJECTIVE	Acute decompensated heart failure ( ADHF ) is associated with significant morbidity and mortality but the relationship between LVEF and outcomes is unclear .
OBJECTIVE	We explored the association between LVEF and 30 and 180day mortality in 7007 ADHF patients enrolled in the Acute Studies of Nesiritide in Decompensated Heart Failure ( ASCEND-HF ) trial .
RESULTS	We explored the association between LVEF and 30 and 180 day mortality in 7007 ADHF patients enrolled in the Acute Studies of Nesiritide in Decompensated Heart Failure ( ASCEND-HF ) trial .
RESULTS	LVEF was analysed both as a continuous variable and according to three categories : < 40 % ( LowEF ) , 40-50 % [ intermediate EF ( IntEF ) ] , and > 50 % [ preserved ejection fraction ( PresEF ) ] .
RESULTS	Of the patients in the trial , 4474 ( 78.7 % ) had LowEF , 674 ( 11.9 % ) had IntEF , and 539 ( 9.5 % ) had PresEF .
RESULTS	The unadjusted 30 and 180 day mortality was similar for LowEF ( 3.7 % , 12.3 % ) , IntEF ( 3.4 % , 13.1 % ) , and PresEF ( 4.3 % , 14.1 % ) , respectively ( P > 0.05 ) .
RESULTS	After multivariable adjustment , the hazard ratio ( HR ) for 180 day mortality remained similar for the LowEF [ HR 0.96 , 95 % confidence interval ( CI ) 0.75-1 .24 ; P = 0.77 ] and IntEF ( 0.91 , 95 % CI 0.66-1 .3 ; P = 0.58 ) compared to PresEF patients .
RESULTS	By contrast , when LVEF was evaluated as a continuous measure , it exhibited a U-shaped pattern with mortality .
RESULTS	After matching for age and sex , the mortality risk attributed to LVEF was attenuated , as the LVEF increased as a continuous variable over 35 % .
RESULTS	However , in patients with EF < 35 % , the mortality risk continue to increase as the LVEF declined .
CONCLUSIONS	Among patients with ADHF , the unadjusted mortality rates are similar across LVEF strata .
CONCLUSIONS	However , after accounting for key patient variables , the mortality risk increases as EF falls below 35 % .
CONCLUSIONS	These data will be useful in planning future studies of ADHF .
BACKGROUND	www.clinicaltrials.gov identifier : NCT00475852 .

###25138079
BACKGROUND	Two randomized intraoperative radiation therapy trials for early-stage breast cancer were recently published .
BACKGROUND	The ELIOT Trial used electrons ( IOERT ) , and the TARGIT-A Trial Update used 50-kV X-rays ( IORT ) .
BACKGROUND	These studies were compared for similarities and differences .
BACKGROUND	The results were analyzed and used to determine which patients might be suitable for single-dose treatment .
METHODS	The primary sources of data were the ELIOT Trial and TARGIT-A Trial , as well as a comprehensive analysis of the peer-reviewed literature of accelerated partial breast irradiation ( APBI ) using 50-kV X-rays or electrons .
METHODS	Studies published or presented prior to March 2014 were analyzed for efficacy , patient restrictions , complications , and outcome .
RESULTS	With a median follow-up of 5.8 years , the 5-year recurrence rates for ELIOT versus EBRT patients were 4.4 and 0.4 % , respectively , p = 0.0001 .
RESULTS	A low-risk ELIOT group was identified with a 5-year recurrence rate of 1.5 % .
RESULTS	With a median follow-up of 29months , the 5-year recurrence rates for the TARGIT-A versus EBRT patients were 3.3 and 1.3 % , respectively , p = 0.042 .
CONCLUSIONS	With 5.8 years of median follow-up , IOERT appears to have a subset of low risk women for whom IOERT is acceptable .
CONCLUSIONS	With 29months of median follow-up the results of IORT with 50-kV devices are promising , but longer follow-up data are required .
CONCLUSIONS	At the current time , single-fraction IOERT or IORT patients should be treated under strict institutional protocols .

###26529159
OBJECTIVE	Advantages of using efavirenz as part of treatment for children infected with human immunodeficiency virus ( HIV ) include once-daily dosing , simplification of co-treatment for tuberculosis , preservation of ritonavir-boosted lopinavir for second-line treatment , and harmonization of adult and pediatric treatment regimens .
OBJECTIVE	However , there have been concerns about possible reduced viral efficacy of efavirenz in children exposed to nevirapine for prevention of mother-to-child transmission .
OBJECTIVE	To evaluate whether nevirapine-exposed children achieving initial viral suppression with ritonavir-boosted lopinavir-based therapy can transition to efavirenz-based therapy without risk of viral failure .
METHODS	Randomized , open-label noninferiority trial conducted at Rahima Moosa Mother and Child Hospital , Johannesburg , South Africa , from June 2010 to December 2013 , enrolling 300 HIV-infected children exposed to nevirapine for prevention of mother-to-child transmission who were aged 3 years or older and had plasma HIV RNA of less than 50 copies/mL during ritonavir-boosted lopinavir-based therapy ; 298 were randomized and 292 ( 98 % ) were followed up to 48 weeks after randomization .
METHODS	Participants were randomly assigned to switch to efavirenz-based therapy ( n = 150 ) or continue ritonavir-boosted lopinavir-based therapy ( n = 148 ) .
METHODS	Risk difference between groups in ( 1 ) viral rebound ( ie , 1 HIV RNA measurement of > 50 copies/mL ) and ( 2 ) viral failure ( ie , confirmed HIV RNA > 1000 copies/mL ) with a noninferiority bound of -0.10 .
METHODS	Immunologic and clinical responses were secondary end points .
RESULTS	The Kaplan-Meier probability of viral rebound by 48 weeks was 0.176 ( n = 26 ) in the efavirenz group and 0.284 ( n = 42 ) in the ritonavir-boosted lopinavir group .
RESULTS	Probabilities of viral failure were 0.027 ( n = 4 ) in the efavirenz group and 0.020 ( n = 3 ) in the ritonavir-boosted lopinavir group .
RESULTS	The risk difference for viral rebound was 0.107 ( 1-sided 95 % CI , 0.028 to ) and for viral failure was -0.007 ( 1-sided 95 % CI , -0.036 to ) .
RESULTS	We rejected the null hypothesis that efavirenz is inferior to ritonavir-boosted lopinavir ( P < .001 ) for both end points .
RESULTS	By 48 weeks , CD4 cell percentage was 2.88 % ( 95 % CI , 1.26 % -4.49 % ) higher in the efavirenz group than in the ritonavir-boosted lopinavir group .
CONCLUSIONS	Among HIV-infected children exposed to nevirapine for prevention of mother-to-child transmission and with initial viral suppression with ritonavir-boosted lopinavir-based therapy , switching to efavirenz-based therapy compared with continuing ritonavir-boosted lopinavir-based therapy did not result in significantly higher rates of viral rebound or viral failure .
CONCLUSIONS	This therapeutic approach may offer advantages in children such as these .
BACKGROUND	clinicaltrials.gov Identifier : NCT01146873 .

###24817596
OBJECTIVE	White rice is the main staple for the majority in the world .
OBJECTIVE	The effects of protein , fat and vegetables on the glycaemic and insulinaemic responses to a white rice-based meal have not been reported .
OBJECTIVE	The aim of this study was to determine the effect of co-ingesting a high-protein food ( breast chicken ) , a fat ( ground nut oil ) , a leafy vegetable or all three on the glycaemic and insulinaemic responses of white rice in healthy adults .
METHODS	This was a randomized crossover trial conducted at the Clinical Nutrition Research Centre in Singapore .
METHODS	Twelve healthy volunteers were given five test meals ( white rice alone , white rice with chicken , white rice with oil , white rice with vegetable and white rice with chicken , oil and vegetable ) once and the reference food ( glucose solution ) three times in a random order at 1-week intervals .
METHODS	Capillary blood samples were then drawn serially for 3 h , and glucose and insulin were analysed .
RESULTS	The glycaemic response ( GR ) to white rice with chicken breast , ground nut oil and vegetable was significantly lower than to white rice alone .
RESULTS	The glycaemic index ( GI ) of pure white rice was 96 , whereas combined with chicken breast , ground nut oil and vegetable , it was 50 .
RESULTS	The addition of oil delayed the peak glucose response and reduced the iAUC , resulting in a GI value of 67 .
RESULTS	The addition of chicken and vegetable resulted in a GI value of 73 and 82 , respectively .
RESULTS	The insulinaemic index ( II ) of the white rice-based meals varied between 54 and 89 .
RESULTS	Chicken breast in the meal increased the insulinaemic response and decreased the GR .
RESULTS	White rice II was lower than the glucose control , which indicated that the former was not as insulinogenic as the latter .
RESULTS	White rice with vegetable had the lowest II .
CONCLUSIONS	Co-ingesting chicken , oil or vegetable with white rice considerably influences its glycaemic and insulinaemic responses .
CONCLUSIONS	Co-ingesting white rice with all three components attenuates the GR to a greater degree than when it is eaten with any single one of them , and that this is not at the cost of an increased demand for insulin .

###24707184
BACKGROUND	Few trials have compared different approaches to cardiovascular disease prevention among Pacific Asian ( PA ) populations .
BACKGROUND	The Cluster Randomized Usual Care versus Caduet Investigation Assessing Long-term-risk ( CRUCIAL ) trial demonstrated that a proactive multifactorial intervention ( PMI ) approach ( based on single-pill amlodipine/atorvastatin ) resulted in a greater reduction in calculated Framingham 10-year coronary heart disease ( CHD ) risk compared with usual care ( UC ) among hypertensive patients with additional risk factors .
BACKGROUND	One-third of CRUCIAL patients resided in the PA region .
BACKGROUND	The aim of this subanalysis was to compare two approaches to cardiovascular risk factor management ( PMI versus UC ) among patients residing in PA and non-PA regions .
METHODS	This subanalysis of the CRUCIAL trial compared treatment-related changes in calculated CHD risk among patients residing in PA and non-PA regions .
METHODS	Sensitivity analyses were conducted among men and women and those with and without diabetes .
RESULTS	Overall , 448 patients ( 31.6 % ) resided in the PA region and 969 patients ( 68.4 % ) resided in non-PA regions .
RESULTS	The PMI approach was more effective in reducing calculated CHD risk versus UC in both PA ( -37.1 % versus -3.5 % ; P < 0.001 ) and non-PA regions ( -31.1 % versus -4.2 % ; P < 0.001 ) ; region interaction P = 0.131 .
RESULTS	PA patients had slightly greater reductions in total cholesterol compared with non-PA patients .
RESULTS	PA patients without diabetes had slightly greater reductions in CHD risk compared with non-PA patients .
RESULTS	Treatment effects were similar in men and women and those with diabetes .
CONCLUSIONS	The PMI approach was more effective in reducing calculated Framingham 10-year CHD risk compared with UC among men and women with and without diabetes residing in the PA and non-PA region .

###24824661
OBJECTIVE	Evidences from cultured cells and animal models of ischemia suggest that lithium has neuroprotective and neurotrophic effects and may play a desirable role in reducing infarct volume and even improving the brain insults from stroke .
OBJECTIVE	The aim of this study was to evaluate the efficacy of lithium in early motor recovery of patients after ischemic stroke .
METHODS	Eighty patients with first ever stroke , allocated randomly in lithium , 300 mg twice daily , or placebo .
METHODS	Treatment was initiated 48 hours after stroke and continued for 30 days .
METHODS	Modified National Institute of Health Stroke Scale ( mNIHSS ) and hand subsection of Fugl-Meyer Assessment ( hFMA ) were used to evaluate impairment on the fifth and 30th day of treatment .
RESULTS	Sixty-six subjects ( 32 subjects in the lithium group and 34 subjects in the placebo group ) completed the study .
RESULTS	There were no significant differences in the improvement in mNIHSS ( P = 0.40 ) and hFMA ( P = 0.07 ) after 30 days .
RESULTS	However , a subgroup analysis showed that patients with cortical strokes in the lithium group had significantly better improvement in both mNIHSS and hFMA in comparison to the placebo group ( P = 0.003 ) .
RESULTS	Approximately 44 % ( n = 14 ) of patients in the lithium group , mainly from the cortical stroke subgroup , regained more than 25 % of full function based on hFMA , whereas this rate in the placebo group was 14.7 % ( n = 5 ; P = 0.009 ) .
CONCLUSIONS	The observed discrete difference between the lithium group and the placebo group in the cortical stroke subgroup may suggest an enhanced motor recovery after stroke by using an early treatment with a low dose of lithium carbonate .
CONCLUSIONS	However , a larger trial with more patients with cortical stroke is needed to investigate this effect better .

###24511015
BACKGROUND	Fitzpatrick 's classification is the most common way of assessing skin UV sensitivity .
BACKGROUND	The study aim was to investigate how self-estimated and actual UV sensitivity , as measured by phototest , are associated with attitudes towards sunbathing and the propensity to increase sun protection , as well as the correlation between self-estimated and actual UV sensitivity .
METHODS	A total of 166 primary healthcare patients filled-out a questionnaire investigating attitudes towards sunbathing and the propensity to increase sun protection .
METHODS	They reported their skin type according to Fitzpatrick , and a UV sensitivity phototest was performed .
RESULTS	Self-rated low UV sensitivity ( skin type III-VI ) was associated with a more positive attitude towards sunbathing and a lower propensity to increase sun protection , compared to high UV sensitivity .
RESULTS	The correlation between the two methods was weak .
CONCLUSIONS	The findings might indicate that individuals with a perceived low but in reality high UV sensitivity do not seek adequate sun protection with regard to skin cancer risk .
CONCLUSIONS	Furthermore , the poor correlation between self-reported and actual UV sensitivity , measured by phototest , makes the clinical use of Fitzpatrick 's classification questionable .

###24450819
BACKGROUND	Intracerebral hemorrhage causes 15 % of strokes annually in the United States , and there is currently no effective therapy .
OBJECTIVE	This is a clinical trial designed to study the safety , feasibility , and efficacy of a protocol of targeted temperature management to moderate hypothermia in intracerebral hemorrhage patients .
METHODS	The targeted temperature management after intracerebral hemorrhage trial is a prospective , single-center , interventional , randomized , parallel , two-arm ( 1:1 ) phase-II clinical trial with blinded end-point ascertainment .
METHODS	Intracerebral hemorrhage patients will be randomized within 18h of symptom onset to either 72h of targeted temperature management to moderate hypothermia ( 32-34C ) followed by a controlled rewarming at of 005-01C per hour or 72h of targeted temperature management to normothermia ( 36-37C ) using endovascular or surface cooling .
RESULTS	The primary outcome is the development of serious adverse events possibly and probably related to treatment .
RESULTS	Secondary outcomes include in-hospital neurological deterioration between day 0-7 , in-hospital mortality , functional outcome measured by the modified Rankin scale at discharge and 90 days , and effect of treatment allocation on cerebral edema and hematoma volume .
CONCLUSIONS	Intracerebral hemorrhage remains the most severe form of stroke with limited options to improve survival .
CONCLUSIONS	As the early resuscitation phase in the intensive care unit represents the greatest opportunity for impact on clinical outcome , it also appears to be the most promising window of opportunity to demonstrate a benefit when investigating aggressive treatments .
CONCLUSIONS	More research of novel therapies to improve outcomes after intracerebral hemorrhage is desperately needed .
CONCLUSIONS	The results of the targeted temperature management after intracerebral hemorrhage clinical trial may provide additional information on the applicability of targeted temperature management after intracerebral hemorrhage .

###24548259
BACKGROUND	The debate about whether energy consumed in liquid form is more obesogenic than energy consumed in solid form remains equivocal .
BACKGROUND	We aimed to evaluate the effects of liquid versus solid energy intake and different beverage types on changes in childhood adiposity .
METHODS	Our analyses included 8-year-old Australian children ( n = 158 ) participating in the Childhood Asthma Prevention Study .
METHODS	Dietary information was collected using three 24-h recalls at age 9 years .
METHODS	Multivariate linear regression was used to evaluate the effects of liquid versus solid energy intake and different beverage types on changes in body mass index ( BMI ) Z-score from ages 8 to 11.5 years ( BMIz ( 8-11 .5 y ) ) and percentage body fat ( % BF ) at age 11.5 years ( % BF ( 11.5 y ) ) .
METHODS	Substitution models were used to evaluate the effects of substituting other beverage types for sugar-sweetened beverages ( SSB ) .
RESULTS	Liquid energy intake ( 1 MJ day ( -1 ) ) was more closely associated with both BMIz ( 8-11 .5 y ) ( = 0.23 , P = 0.02 ) and % BF ( 11.5 y ) ( = 2.31 % , P = 0.01 ) than solid energy intake ( BMIz ( 8-11 .5 y ) : = 0.12 , P = 0.01 and % BF ( 11.5 y ) : = 0.80 % , P = 0.07 ) .
RESULTS	SSB consumption ( 100 g day ( -1 ) ) was directly associated with BMIz ( 8-11 .5 y ) ( = 0.08 , P = 0.02 ) and % BF ( 11.5 y ) ( = 0.92 % , P = 0.004 ) , whereas diet drinks ( 100 g day ( -1 ) ) were inversely associated with BMIz ( 8-11 .5 y ) ( = 0.18 , P = 0.02 ) .
RESULTS	Substitution of 100 g of SSB by 100 g of water or diet drink , but not other beverages , was inversely associated with both BMIz ( 8-11 .5 y ) and % BF ( 11.5 y ) ( P < 0.01 ) .
CONCLUSIONS	Our findings indicate that liquid energy is more obesogenic than solid energy .
CONCLUSIONS	In particular , SSB , but not other beverage types , are a significant predictor of childhood adiposity and replacing SSB with water can have long-term beneficial effects on childhood adiposity .

###24395980
OBJECTIVE	- blockers are the standard treatment for myocardial infarction ( MI ) based on evidence from the pre-thrombolytic era .
OBJECTIVE	The aim of this study was to examine the effect of - blocker treatment in patients with acute MI and preserved systolic function in the era of percutaneous coronary intervention ( PCI ) .
METHODS	We analysed a multicentre registry and identified 3019 patients who presented with acute MI between 2004 and 2009 .
METHODS	Patients were treated with PCI , had left ventricular EFs 50 % according to echocardiograms that were performed during the index PCI , and were alive at the time of discharge .
METHODS	The association between - blocker use after discharge and mortality ( all-cause death and cardiac death ) within 3 years was examined .
RESULTS	Patients who were not treated with - blockers ( n = 595 ) showed higher rates of all-cause death and cardiac death compared to patients treated with - blockers ( 10.8 % vs 5.7 % , p < 0.001 , 7.6 % vs 2.6 % , p < 0001 ) .
RESULTS	The multivariate Cox proportional hazards model showed that - blocker treatment was associated with a significant reduction in all-cause death ( adjusted HR 0.633 , 95 % CI 0.464 to 0.863 ; p = 0.004 ) and cardiac death ( adjusted HR 0.47 , 95 % CI 0.32 to 0.70 ; p < 0.001 ) .
RESULTS	Comparable results were obtained after propensity score matching .
CONCLUSIONS	- blocker treatment was associated with reduced long term mortality in patients with acute MI and preserved systolic function who received PCI .

###25978109
BACKGROUND	We have found that hydrogen ( dihydrogen [ H2 ] ) decreases plasma low-density lipoprotein ( LDL ) cholesterol levels and improves high-density lipoprotein ( HDL ) function in patients with potential metabolic syndrome in a before-after self-controlled study .
OBJECTIVE	The purpose of this study was to further characterize the effects of H2-rich water ( 0.9 L/day ) on the content , composition , and biological activities of plasma lipoproteins on patients with hypercholesterolemia and their underlying mechanisms in a double-blinded , randomized , and placebo-controlled trial .
METHODS	This was a case-control study .
METHODS	The setting was the Zhoudian community , Tai'an , China .
METHODS	A total of 68 patients with untreated isolated hypercholesterolemia were randomly allocated to either drinking H2-rich water ( n = 34 ) or placebo water ( n = 34 ) for 10 weeks .
RESULTS	HDL isolated from the H2 group showed an increased ability to promote the ATP-binding cassette transporter A1-mediated cholesterol efflux ex vivo .
RESULTS	Plasma pre -- HDL levels were up-regulated although there were no changes in plasma HDL-cholesterol levels .
RESULTS	Moreover , other HDL functions , assessed in protection against LDL oxidation , inhibition of oxidized-LDL-induced inflammation , and protection of endothelial cells from oxidized-LDL-induced apoptosis , were all significantly improved by H2 treatment .
RESULTS	In addition , H2 treatment increased the effective rate in down-regulating plasma levels of total cholesterol ( 47.06 % vs 17.65 % ) and LDL cholesterol ( 47.06 % vs 23.53 % ) .
RESULTS	Western blot analysis revealed a marked decrease in apolipoprotein B100 and an increase in apolipoprotein M in plasma of the H2 group .
RESULTS	Finally H2 treatment resulted in a significant reduction in the levels of several inflammatory and oxidative stress indicators in whole plasma and HDL particles .
CONCLUSIONS	H2 activates ATP-binding cassette transporter A1-dependent efflux , enhances HDL antiatherosclerotic functions , and has beneficial lipid-lowering effects .
CONCLUSIONS	The present findings highlight the potential role of H2 in the regression of hypercholesterolemia and atherosclerosis .

###25299442
BACKGROUND	Persistent muscle weakness after anterior cruciate ligament ( ACL ) reconstruction may be due to underlying activation failure and arthrogenic muscle inhibition ( AMI ) .
BACKGROUND	Knee-joint cryotherapy has been shown to improve quadriceps function transiently in those with AMI , thereby providing an opportunity to improve quadriceps muscle activation and strength in patients with a reconstructed ACL .
OBJECTIVE	To compare quadriceps muscle function in patients with a reconstructed ACL who completed a 2-week intervention including daily cryotherapy ( ice bag ) , daily exercises , or both .
METHODS	Cross-sectional study .
METHODS	Laboratory .
METHODS	A total of 30 patients with reconstructed ACLs who were at least 6 months post-index surgery and had measurable quadriceps AMI .
METHODS	The patients attended 4 supervised visits over a 2-week period .
METHODS	They were randomly assigned to receive 20 minutes of knee-joint cryotherapy , 1 hour of therapeutic rehabilitation exercises , or cryotherapy followed by exercises .
METHODS	We measured quadriceps Hoffmann reflex , normalized maximal voluntary isometric contraction torque , central activation ratio using the superimposed-burst technique , and patient-reported outcomes before and after the intervention period .
RESULTS	After the 2-week intervention period , patients who performed rehabilitation exercises immediately after cryotherapy had higher normalized maximal voluntary isometric contraction torques ( P = .002 , Cohen d effect size = 1.4 ) compared with those who received cryotherapy alone ( P = .16 , d = 0.58 ) or performed exercise alone ( P = .16 , d = 0.30 ) .
CONCLUSIONS	After ACL reconstruction , patients with AMI who performed rehabilitation exercises immediately after cryotherapy experienced greater strength gains than those who performed cryotherapy or exercises alone .

###24894386
BACKGROUND	Organ dysfunction consequent to infection ( ` severe sepsis ' ) is the leading cause of admission to an intensive care unit ( ICU ) .
BACKGROUND	In both animal models and early clinical studies the calcium channel sensitizer levosimendan has been demonstrated to have potentially beneficial effects on organ function .
BACKGROUND	The aims of the Levosimendan for the Prevention of Acute oRgan Dysfunction in Sepsis ( LeoPARDS ) trial are to identify whether a 24-hour infusion of levosimendan will improve organ dysfunction in adults who have septic shock and to establish the safety profile of levosimendan in this group of patients .
METHODS	This is a multicenter , randomized , double-blind , parallel group , placebo-controlled trial .
METHODS	Adults fulfilling the criteria for systemic inflammatory response syndrome due to infection , and requiring vasopressor therapy , will be eligible for inclusion in the trial .
METHODS	Within 24 hours of meeting these inclusion criteria , patients will be randomized in a 1:1 ratio stratified by the ICU to receive either levosimendan ( 0.05 to 0.2 g.kg.min or placebo for 24 hours in addition to standard care .
METHODS	The primary outcome measure is the mean Sequential Organ Failure Assessment ( SOFA ) score while in the ICU .
METHODS	Secondary outcomes include : central venous oxygen saturations and cardiac output ; incidence and severity of renal failure using the Acute Kidney Injury Network criteria ; duration of renal replacement therapy ; serum bilirubin ; time to liberation from mechanical ventilation ; 28-day , hospital , 3 and 6 month survival ; ICU and hospital length-of-stay ; and days free from catecholamine therapy .
METHODS	Blood and urine samples will be collected on the day of inclusion , at 24 hours , and on days 4 and 6 post-inclusion for investigation of the mechanisms by which levosimendan might improve organ function .
METHODS	Eighty patients will have additional blood samples taken to measure levels of levosimendan and its active metabolites OR-1896 and OR-1855 .
METHODS	A total of 516 patients will be recruited from approximately 25 ICUs in the United Kingdom .
CONCLUSIONS	This trial will test the efficacy of levosimendan to reduce acute organ dysfunction in adult patients who have septic shock and evaluate its biological mechanisms of action .
BACKGROUND	Current controlled trials ISRCTN12776039 ( 19 September 2013 ) .

###25632742
OBJECTIVE	To assess the efficacy and safety of Wuji Powder ( WP ) and a small dose aripiprazole in treatment of antipsychotic drug-induced phlegm dampness type amenorrhea .
METHODS	Seventy female schizophrenic patients with antipsychotic drug-induced galactorrhea-amenorrhea syndrome ( GAS ) were recruited and randomly assigned to the treatment group and the control group , 35 in each group .
METHODS	All patients received antipsychotic drug therapy .
METHODS	Patients in the treatment group additionally took WP , while those in the control group took aripiprazole ( at the daily dose of 5 mg , once daily ) .
METHODS	The therapeutic course for all was 4 weeks .
METHODS	Prolactin levels and obesity indices [ body weight , waist aircumstance , body mass index ( BMI ) and waist-hit ratio ( WHR ) ] were determined before and after treatment .
METHODS	The efficacy was evaluated .
RESULTS	The treatment course was completed in 95.71 % of patients .
RESULTS	The total effective rate of the 33 patients of the treatment group was 93.94 % ( 31/33 ) , while it was 91.18 % ( 31/34 ) in the 34 patients of the control group .
RESULTS	There was no difference in the total effective rate between the two groups ( P > 0.05 ) .
RESULTS	Prolactin levels in both group after treatment were significantly lower than those of the baseline ( P < 0.01 ) .
RESULTS	There was no significant difference in prolactin levels between the two groups after treatment ( P > 0.05 ) .
RESULTS	Compared with before treatment , body weight , BMI , waist circumstance , and waist-hip ratio obviously decreased after treatment , showing significant difference when compared with the control group ( P < 0.05 ) .
RESULTS	There was no significant difference in body weight , BMI , waist circumstance , and waist-hip ratio in the control group between before and after treatment ( P > 0.05 ) .
CONCLUSIONS	Both WP and aripiprazole could lower high prolactin levels of schizophrenics with phlegm dampness type amenorrhea .
CONCLUSIONS	They showed equivalent efficacy .
CONCLUSIONS	But WP showed more obvious effect in reducing obesity indices .

###25495720
OBJECTIVE	The long-term efficacy and safety of canagliflozin , a sodium glucose co-transporter 2 inhibitor , was evaluated over 104weeks in patients aged 55-80years with type 2 diabetes mellitus ( T2DM ) inadequately controlled on a stable antihyperglycaemic agent regimen .
METHODS	In this randomized , double-blind , phase III study , patients received canagliflozin 100 or 300mg or placebo once daily during a 26-week core period ( N = 714 ) and a 78-week extension period ( n = 624 ) .
METHODS	Efficacy endpoints at week 104 included change from baseline in glycated haemoglobin ( HbA1c ) , fasting plasma glucose ( FPG ) and systolic blood pressure , and percent change from baseline in body weight and fasting plasma lipids .
METHODS	Safety was assessed by adverse event ( AE ) reports .
RESULTS	At week 104 , canagliflozin 100 and 300mg were associated with reductions in HbA1c versus placebo ( -0.32 and -0.43 % vs 0.17 % , respectively ; overall mean baseline , 7.7 % ) and more patients achieved HbA1c < 7.0 % with canagliflozin 100 and 300mg than with placebo ( 35.8 and 41.9 % vs 20.3 % , respectively ) .
RESULTS	Reductions in FPG , body weight and systolic blood pressure , and increases in high-density lipoprotein cholesterol ( HDL-C ) and low-density lipoprotein cholesterol ( LDL-C ) were seen with canagliflozin compared with placebo .
RESULTS	The overall incidence rates of AEs over 104weeks were 88.0 , 89.8 and 86.1 % with canagliflozin 100 and 300mg and placebo , respectively ; serious AE rates were low across treatment groups .
RESULTS	The incidence rates of urinary tract infections , genital mycotic infections and osmotic diuresis - and volume depletion-related AEs were higher with canagliflozin than with placebo .
CONCLUSIONS	Canagliflozin improved glycaemic control , reduced body weight and systolic blood pressure , and was generally well tolerated in patients aged 55-80years with T2DM over 104weeks .

###24945194
BACKGROUND	Thalidomide use in cutaneous sarcoidosis is based on data from small case series or case reports .
BACKGROUND	The objective of this study was to evaluate the efficacy and safety of thalidomide in severe cutaneous sarcoidosis .
METHODS	This study consisted of a randomized , double-bind , parallel , placebo-controlled , investigator-masked , multicenter trial lasting 3 months and an open-label study from month 3 to month 6 .
METHODS	Adults with a clinical and histologic diagnosis of cutaneous sarcoidosis were included in nine hospital centers in France .
METHODS	Patients were randomized 1:1 to oral thalidomide ( 100 mg once daily ) or to a matching oral placebo for 3 months .
METHODS	In the course of an open-label follow-up from month 3 to month 6 , all patients received thalidomide , 100 mg to 200 mg daily .
METHODS	The proportions of patients with a partial or complete cutaneous response at month 3 , based on at least a 50 % improvement in three target lesions scored for area and infiltration , were compared across randomization groups .
RESULTS	The intent-to-treat population included 39 patients .
RESULTS	None of them had a complete cutaneous response .
RESULTS	Four out of 20 patients in the thalidomide group ( 20 % ) vs four out of 19 patients in the placebo group ( 21 % ) had a partial cutaneous response at month 3 ( difference in proportion of -1 % [ 95 % CI , -26 % to +24 % ] for thalidomide vs placebo , P = 1.0 ) .
RESULTS	Eight patients with side effects were recorded in the thalidomide group vs three in the placebo group .
RESULTS	We observed a large number of adverse event-related discontinuations in patients taking thalidomide in the first 3 months ( four patients with thalidomide , zero with placebo ) and in the 3 following months ( five patients ) .
CONCLUSIONS	At a dose of 100 mg daily for 3 months , our results do not encourage thalidomide use in cutaneous sarcoidosis .
BACKGROUND	ClinicalTrials.gov ; No. : NCT0030552 ; URL : www.clinicaltrials.gov .

###24404799
OBJECTIVE	To assess whether medical record documentation reflects actual home practices regarding the administration of preventive medications to urban children with persistent asthma .
METHODS	Baseline data from a prompting asthma intervention were used for this cross-sectional analysis .
METHODS	As part of the larger study , we enrolled children ( 2-12 years ) with persistent asthma in the waiting room at 12 primary care offices ( 2009-2012 ) .
METHODS	Prior to their visit with a healthcare provider , caregivers reported information regarding their child 's asthma symptom severity and current preventive medications ( i.e. name and frequency of use ) .
METHODS	We compared caregiver-reported medication information with medical record data to determine the rate of complete concordance , defined as total consistency between the prescribed medication data documented in the medical record and parent report describing how the child is actually using the medication at home .
RESULTS	According to 310 completed medical record reviews , 194 ( 62 % ) children had a current prescription for a daily preventive asthma medication .
RESULTS	Of these children , 110 ( 57 % ) had caregivers who reported complete concordance .
RESULTS	Those reporting complete concordance were more likely to have children with greater symptom severity , including fewer symptom-free days in the prior two weeks ( 6.9 vs. 8.7 , p = 0.018 ) , and 1 asthma-related hospitalization in the prior year ( 16 % vs. 6 % , p = 0.042 ) .
CONCLUSIONS	Medical records may poorly reflect actual home practices and providers should specifically inquire about medication use and barriers to adherence at the time of an office visit to promote guideline-based , consistent treatment for children with persistent asthma .

###25355252
OBJECTIVE	To determine the pathological mechanism and prevent heart-renal syndrome after heart valve replacement surgery .
METHODS	A total of 46 patients were admitted for selective valve replacement , and divide into 3 groups randomly : a control group ( Con , n = 16 ) , a remote ischemic perconditioning ( RIPerC ) group ( n = 15 ) and a remote ischemic postconditioning ( RIPostC ) group ( n = 15 ) .
METHODS	The serum creatinine ( SCr ) , blood urea nitrogen ( BUN ) , serum heme oxygennase-1 ( HO-1 ) , serum iron and urinary neutrophil gelatinase associated lipocalin ( NGAL ) level in the 3 groups were compared preoperatively and 6 , 12 , 24 , 48 h after aortic cross-release .
RESULTS	Compared with the preoperative level , the SCr , BUN , urinary NGAL , serum iron ( 6 and 12 h ) and serum HO-1 values were significantly increased after the heart valve replacement surgery in the control patients , RIPreC and RIPostC groups ( P < 0.05 ) .
RESULTS	Compared with the control group , the serum HO-1 was significantly increased at 6 , 12 , 24 , 48 h after the heart valve replacement surgery in both the RIPerC and RIPostC groups ( P < 0.05 ) ; the SCr , BUN , urinary NGAL and serum iron values were decreased at 6 , 12 , 24 , 48 h after the heart valve replacement surgery in both the RIPerC and RIPostC groups ( P > 0.05 ) .
CONCLUSIONS	Abnormal change in urinary NGAL , serum iron and HO-1 can be used as early warning indicators of acute kidney injury when cardio-renal syndrome occurrs among patients under heart valve replacement surgery .
CONCLUSIONS	Remote ischemic conditioning plays a preventive role in the occurrence of cardio-renal syndrome and renal protection .

###25457738
BACKGROUND	The autobiographical Implicit Association Test ( aIAT ) is a variant of the Implicit Association Test reportedly capable of detecting an individual 's concealed autobiographical event with very high accuracy .
BACKGROUND	A previous attempt to utilize this measurement technique for the identification of cocaine users rendered an alarming rate of false positives .
BACKGROUND	In this study , we aimed to explore the potential reasons behind the measurement 's inaccuracy .
METHODS	Two versions of the cocaine aIAT were devised with different category labels ( descriptive ` guilty/innocent ' and self-referenced ` as if you were/were not ' ) .
METHODS	Forty-one cocaine abstinent participants ( 43.9 % male ; mean age = 28.17 7.36 ) were randomly assigned to one of the two conditions .
METHODS	Self-declared cocaine abstinence was confirmed for the 12-month period preceding data collection through hair analysis .
METHODS	Participants were also administered bespoke implicit and explicit cocaine user attitude measures , the self-esteem IAT and the Rosenberg self-esteem scale .
RESULTS	The category labels which elicited self-referenced knowledge showed low accuracy ( 19 % ) compared to the 65 % of the ` guilty/innocent ' labels proposed by original authors .
RESULTS	The self-referenced aIAT version significantly correlated with the self-concept measures .
RESULTS	The aIAT outcomes were independent from attitudes toward cocaine users .
CONCLUSIONS	Category labels play an influential role in determining the test 's accuracy , demonstrating that participants ' propositional knowledge and self-concept are involved during test performance .
CONCLUSIONS	The aIAT does not appear to tap directly into an individual 's implicit memory when relevant memory is not available .
CONCLUSIONS	Although the test can not be recommended for detecting drug use , further research should investigate underlying mechanisms and other potentials of the technique .

###25437481
OBJECTIVE	To prospectively compare the achieved thickness and consistency of LASIK flaps created with a 60 - and 150-kHz femtosecond laser .
METHODS	One hundred twenty eyes of 60 patients with myopia were treated with LASIK .
METHODS	One eye had flap created by the Intralase FS 60-kHz femtosecond laser ( Abbott Medical Optics , Abbott Park , IL ) and the fellow eye was treated with the IntraLase iFS 150-kHz femtosecond laser ( Abbott Medical Optics ) .
METHODS	Eyes were randomized according to ocular dominance .
METHODS	Flap morphology and measurements were taken with anterior segment optical coherence tomography ( AS-OCT ) at the 1-month postoperative visit .
RESULTS	AS-OCT showed similar regular planar morphologies in both groups .
RESULTS	The mean thickness of the flaps in the FS 60 group was significantly higher than that of the iFS 150 group ( 105.4 3.9 m vs 103.9 4.8 m , P = .009 ) .
RESULTS	The mean deviation from targeted flap thickness was not significantly different between the two groups .
CONCLUSIONS	The Intralase iFS 150-kHz femtosecond laser creates flaps of similar thickness and uniformity to the Intralase FS 60-kHz femtosecond laser .

###25247953
OBJECTIVE	Periprosthetic bone cysts are a known finding after total ankle replacement ( TAR ) .
OBJECTIVE	The significance of cysts is uncertain , but they may threaten the long-term survival of the implant .
OBJECTIVE	The aim of this prospective study was to evaluate the diagnostic accuracy of weight-bearing digital radiography compared with 3D weight-bearing multiplanar reconstructed ( MPR ) fluoroscopic imaging when diagnosing periprosthetic bone cysts in patients who have undergone TAR .
METHODS	Forty-two consecutive patients with a Scandinavian Total Ankle Replacement ( STAR ) were consecutively enrolled and underwent digital radiography and 3D MPR imaging in the same session .
METHODS	All 3D MPR images were interpreted in a blinded fashion , specifically with regard to the presence and extent of periprosthetic bone cysts .
METHODS	Cysts were measured in three planes whenever possible .
METHODS	Interrater and intrarater reliability was assessed by using Cohen kappa test , and comparisons between the two modalities were performed with the Wilcoxon signed-rank and McNemar tests .
RESULTS	Significantly more cysts were detected on 3D MPR ( 74 vs 55 ) ( p = 0.03 ) , with the mean size of cysts detected by 3D MPR significantly larger than that of cysts diagnosed on digital radiography ( 1545 mm ( 3 ) vs 253 mm ( 3 ) ) ( p < 0.0001 ) .
RESULTS	Statistical analysis based on the presence or absence of cysts in individual patients did not show a significant difference between 3D MPR and digital radiography ( p = 0.23 ) .
CONCLUSIONS	The data imply that cysts are better detected and more accurately measured with 3D fluoroscopic MPR imaging compared with digital radiography , which underestimates not only the presence but also the extent of periprosthetic cysts .

###25218876
OBJECTIVE	Oxidative stress and systemic inflammation are highly prevalent in patients undergoing maintenance hemodialysis ( MHD ) and are linked to excess cardiovascular risk .
OBJECTIVE	This study examined whether short-term supplementation with pomegranate juice and extract is safe and well tolerated by MHD patients .
OBJECTIVE	The secondary aim was to assess the effect of pomegranate supplementation on oxidative stress , systemic inflammation , monocyte function , and blood pressure .
METHODS	Prospective , randomized , crossover , pilot clinical trial ( NCT01562340 ) .
METHODS	The study was conducted from March to October 2012 in outpatient dialysis facilities in the Seattle metropolitan area .
METHODS	Twenty-four patients undergoing MHD ( men , 64 % ; mean age , 6114years ) were randomly assigned to receive pomegranate juice or extract during a 4-week intervention period .
METHODS	After a washout period , all patients received the alternative treatment during a second 4-week intervention period .
METHODS	Patients assigned to receive pomegranate juice received 100mL of juice before each dialysis session .
METHODS	Patients assigned to receive pomegranate extract were given 1,050 mg of extract daily .
METHODS	The main outcome measures were safety and tolerability of pomegranate juice and extract .
METHODS	Additional secondary outcomes assessed included serum lipids , laboratory biomarkers of inflammation ( C-reactive protein and interleukin 6 ) and oxidative stress ( plasma F2 isoprostanes and isofurans ) , monocyte cytokine production , and predialysis blood pressure .
RESULTS	Both pomegranate juice and extract were safe and well tolerated by study participants .
RESULTS	Over the study period , neither treatment had a significant effect on lipid profiles , plasma C-reactive protein , interleukin 6 , F2-isoprostane or isofuran concentrations , predialysis systolic or diastolic blood pressure nor changed the levels of monocyte cytokine production .
CONCLUSIONS	Both pomegranate juice and extract are safe and well tolerated by patients undergoing MHD but do not influence markers of inflammation or oxidative stress nor affect predialysis blood pressure .

###25995276
BACKGROUND	Lipid-based nutrient supplements ( LNSs ) offer a vehicle to improve children 's diets in low-income countries where complementary foods are typically deficient in essential nutrients .
BACKGROUND	Sustained acceptability by the intended users is essential for achieving growth-promoting effects .
OBJECTIVE	We aimed to determine the sustained acceptability of LNSs among 6 - to 18-mo-old children in Malawi .
METHODS	In the context of a trial testing the growth-promoting effect of different formulations and doses of LNSs , we delivered LNSs to the homes of the children biweekly according to the randomization protocol .
METHODS	We defined acceptability to include adherence to feeding recommendations and mothers ' experiences of feeding LNSs to their child .
METHODS	We conducted brief interviews each week with the mothers .
METHODS	At 2 time points we conducted knowledge , attitudes , and practices ( KAP ) interviews .
METHODS	In addition , we conducted repeated in-depth interviews with a subset of mothers .
RESULTS	Of the 1612 children who received the LNS intervention , we analyzed adherence data from 1478 ( 91.7 % ) children and KAP data at 2 time points ( child 's age of 12 and 18 mo ) from 839 ( 52.1 % ) of the children .
RESULTS	The mean SD overall adherence ( proportion of days when the study child reportedly consumed LNSs considering only those weeks when the supplement had been successfully delivered to the home ) was 92.4 9.6 % , and there was no difference between children receiving milk-containing or milk-free LNSs .
RESULTS	There was also no increasing or decreasing trend over time in any of the groups .
RESULTS	Sharing and deviation from other feeding recommendations were common .
RESULTS	Maternal experiences were mostly very positive .
CONCLUSIONS	The acceptability of LNS products was good and was sustained for 12 mo in this rural Malawian population .
CONCLUSIONS	However , sharing of the products with family members and deviation from other feeding recommendations were frequent , which means that individually targeted children were likely to receive less than the intended dose of the LNS .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT00945698 .

###24980811
OBJECTIVE	To compare the patients ' compliance with and the efficacy of existing treatments for Helicobacter pylori eradication , including moxifloxacin-based triple therapy , sequential treatment and the standard treatment .
METHODS	Patients with H.pylori infection were randomly assigned to three therapy groups .
METHODS	The triple therapy ( MML ) group was given moxifloxacin 400mg/day , metronidazole 500mg b.i.d. and lansoprazole 30mg b.i.d. for 10 days .
METHODS	The sequential treatment ( AL-CML ) group was administrated amoxicillin 1g b.i.d. and lansoprazole 30mg b.i.d. for the first 5 days , followed by clarithromycin 500mg b.i.d. , metronidazole 500mg b.i.d. and lansoprazole 30mg b.i.d. for the second 5 days .
METHODS	The standard treatment ( CAL ) group received amoxicillin 1g b.i.d. , clarithromycin 500mg b.i.d. and lansoprazole 30mg b.i.d. for 14 days .
METHODS	The eradication rates were evaluated by per-protocol ( PP ) analysis and intention-to-treat ( ITT ) analysis .
RESULTS	The eradication rates were 87.1 , 85.9 and 85.2 % by PP analysis and 87.1 , 84.9 and 84.2 % by ITT analysis in the MML , AL-CML and CAL group , respectively , and patients ' compliance rates were 98.2 , 96.5 and 97.1 % , respectively .
RESULTS	There were no significant differences in treatment efficacy and compliance rates in the MML , AL-CML and CAL groups ( P > 0.05 ) .
CONCLUSIONS	The present study revealed that standard triple therapy , sequential therapy and moxifloxacin-based triple therapy are all effective treatment regimens in terms of H.pylori eradication rates and compliance with therapy in Turkey .

###26139054
BACKGROUND	Treatment of patients with drug-eluting stent ( DES ) in-stent restenosis ( ISR ) remains a major challenge .
OBJECTIVE	This study evaluated the comparative efficacy of drug-eluting balloons ( DEB ) and everolimus-eluting stents ( EES ) in patients presenting with DES-ISR .
METHODS	The study design of this multicenter randomized clinical trial assumed superiority of EES for the primary endpoint , in-segment minimal lumen diameter at the 6 - to 9-month angiographic follow-up .
RESULTS	A total of 309 patients with DES-ISR from 23 Spanish university hospitals were randomly allocated to DEB ( n = 154 ) or EES ( n = 155 ) .
RESULTS	At late angiography ( median 247 days ; 90 % of eligible patients ) , patients in the EES arm had a significantly larger minimal lumen diameter ( 2.03 0.7 mm vs. 1.80 0.6 mm ; p < 0.01 ) ( absolute mean difference : 0.23 mm ; 95 % CI : 00.7 to 0.38 ) , net lumen gain ( 1.28 0.7 mm vs. 1.01 0.7 mm ; p < 0.01 ) , and lower percent diameter stenosis ( 23 22 % vs. 30 22 % ; p < 0.01 ) and binary restenosis rate ( 11 % vs. 19 % ; p = 0.06 ) , compared with patients in the DEB arm .
RESULTS	Consistent results were observed in the in-lesion analysis .
RESULTS	At the 1-year clinical follow-up ( 100 % of patients ) , the main clinical outcome measure ( composite of cardiac death , myocardial infarction , and target vessel revascularization ) was significantly reduced in the EES arm ( 10 % vs. 18 % ; p = 0.04 ; hazard ratio : 0.58 ; 95 % CI : 0.35 to 0.98 ) , mainly driven by a lower need for target vessel revascularization ( 8 % vs. 16 % ; p = 0.035 ) .
CONCLUSIONS	In patients with DES-ISR , EES provided superior long-term clinical and angiographic results compared with DEB .
CONCLUSIONS	( Restenosis Intra-Stent of Drug-Eluting Stents : Drug-Eluting Balloon vs Everolimus-Eluting Stent [ RIBS IV ] ; NCT01239940 ) .

###24556754
OBJECTIVE	The aim of the present study was to evaluate whether the order of complementary feeding in relation to breast-feeding affects breast milk , semisolid , or total energy intake in infants .
METHODS	The present study was designed as a randomized crossover trial .
METHODS	The study was conducted in a tertiary care hospital .
METHODS	The study participants were 25 healthy infants between the ages of 7 and 11 months who were exclusively breast-fed for at least 6 months and were now receiving complementary foods for at least 1 month in addition to breast-feeding .
METHODS	Infants were randomized to follow a sequence of either complementary feeding before breast-feeding ( sequence A ) or complementary feeding after breast-feeding ( sequence B ) for the first day ( 24 hours ) of the study period using simple randomization .
METHODS	For the next day , the sequence was reversed for each child .
METHODS	All babies received 3 actively fed complementary food meals per day ( morning , afternoon , and evening ) .
METHODS	A semisolid study diet was prepared in the hospital by cooking rice and pulse with oil using a standard method , ensuring the energy density of at least 0.6 kcal/g .
METHODS	The infants were allowed ad libitum breast-feeding during the observation period .
METHODS	Semisolid intake was directly measured and breast milk intake was quantified by test weighing method .
METHODS	Energy intake from complementary foods was calculated from the product of energy density of the diet served on that day and the total amount consumed .
METHODS	The total energy intake and energy intake from breast milk and complementary foods between the 2 sequences were compared .
RESULTS	The mean ( standard deviation ) energy intake from breast milk during 12 hours of daytime by following sequence A ( complementary feeding before breast-feeding ) was 132.0 ( 67.4 ) kcal in comparison with 135.9 ( 56.2 ) kcal in sequence B , which was not statistically different ( P = 0.83 ) .
RESULTS	The mean ( standard deviation ) energy consumed from semisolids in sequences A and B was also comparable ( 88.6 [ 75.5 ] kcal vs. 85.5 [ 89.7 ] kcal ; P = 0.58 ) .
RESULTS	The total energy intake during daytime in sequence A was 220.6 ( 96.2 ) kcal in comparison with 221.5 ( 94.0 ) kcal in sequence B , which was also comparable ( P = 0.97 ) .
RESULTS	The results related to energy intake through breast milk and total energy intake were not different when insensible losses during feeding were adjusted in both groups .
CONCLUSIONS	Altering the sequence of complementary feeding in relation to breast-feeding does not affect total energy intake .

###24295403
BACKGROUND	Our objective was to determine the interrelationships of interleukin ( IL ) -6 receptor inhibition with haemoglobin , acute-phase reactants and iron metabolism markers ( including hepcidin ) in patients with rheumatoid arthritis ( RA ) .
METHODS	Data of patients receiving tocilizumab or placebo in the MEASURE study were analysed .
METHODS	We investigated associations at baseline and during tocilizumab treatment among haemoglobin , parameters of haemoglobin and iron homeostasis [ ferritin , total iron-binding capacity ( TIBC ) , hepcidin , haptoglobin ] , IL-6 and acute-phase reactants [ C-reactive protein ( CRP ) , erythrocyte sedimentation rate ( ESR ) ] to identify statistical correlates of rise in haemoglobin level .
RESULTS	At baseline , CRP and haptoglobin were inversely correlated ( modestly ) with haemoglobin levels .
RESULTS	After treatment with tocilizumab , CRP , hepcidin , ferritin and haptoglobin levels fell alongside increases in TIBC and haemoglobin .
RESULTS	The falls in CRP , hepcidin and haptoglobin levels in the first 2 weeks correlated with a week 12 rise in TIBC and haemoglobin .
CONCLUSIONS	Inflammatory anaemia improves in patients with RA treated with tocilizumab .
CONCLUSIONS	This improvement correlates with the degree of suppression of systemic inflammation , reduction in hepcidin and haptoglobin and increase in iron-binding capacity .
CONCLUSIONS	These clinical data provide evidence of a role for IL-6 signalling in the inflammatory anaemia of RA .

###25219563
BACKGROUND	In randomized clinical studies , over 11,800 children , 12 months to 6 years of age , were administered ProQuad ( ) , a combination measles , mumps , rubella , and varicella vaccine ( MMRV ) .
BACKGROUND	This paper describes the safety following a 2-dose regimen of MMRV administered to children in the second year of life .
METHODS	Safety data from five clinical studies were combined for all children who were scheduled to receive two doses of MMRV 3-6 months apart .
METHODS	All vaccinated children were followed for safety following each dose of MMRV .
RESULTS	Of 3112 children who received a first dose of MMRV , 2780 ( 89.3 % ) received a second dose of MMRV .
RESULTS	Overall , 70.5 % and 57.7 % of children reported 1 adverse experiences following first and second doses of MMRV , respectively .
RESULTS	Injection-site redness was statistically significantly higher postdose 2 than postdose 1 , while injection-site pain/tenderness was statistically significantly higher postdose 1 compared to postdose 2 .
RESULTS	Rashes were statistically significantly lower postdose 2 compared to postdose 1 .
RESULTS	Ten febrile seizures ( 8 postdose 1 , 2 postdose 2 ) were reported following MMRV vaccination .
RESULTS	The incidence of febrile seizures postdose 1 of MMRV was 0.26 % ( 8/3019 ) compared to 0.07 % ( 2/2695 ) postdose 2 of MMRV .
CONCLUSIONS	Administration of two doses of MMRV has an acceptable safety profile in children 12 to 23 months of age .
CONCLUSIONS	There is a small increase in the risk of febrile seizures following the first dose of MMRV as compared to the component vaccines , but the risk for any individual child is relatively low .

###24650118
OBJECTIVE	To evaluate the cost-effectiveness of treating patients with acute coronary syndromes ( ACS ) for 12 months with ticagrelor compared with generic clopidogrel in Sweden and Denmark .
METHODS	Decision-analytic model to estimate lifetime costs , life-expectancy , and quality-adjusted life years ( QALYs ) with ticagrelor and clopidogrel .
METHODS	Event rates , healthcare resource use , and health-related quality of life during 12 months of therapy were estimated from the PLATelet inhibition and patient Outcomes ( PLATO ) trial .
METHODS	Beyond 12 months , quality-adjusted survival and costs were estimated conditional on events occurring during the 12 months of therapy .
METHODS	When available , country-specific data were employed in the analysis .
METHODS	Incremental cost-effectiveness ratios are presented from a healthcare perspective and a broader societal perspective including costs falling outside the healthcare sector in 2010 local currency .
RESULTS	The cost per QALY with ticagrelor compared with generic clopidogrel was SEK 25 022 and DKK 26 892 for Sweden and Denmark , respectively , from a healthcare perspective .
RESULTS	The cost per QALY from a broader societal perspective was SEK 24 290 and DKK 25 051 for Sweden and Denmark , respectively .
CONCLUSIONS	The cost per QALY of treating ACS-patients with ticagrelor compared with generic clopidogrel is below the conventional thresholds of cost-effectiveness in Sweden and Denmark .

###24581813
OBJECTIVE	To evaluate the effectiveness of a food safety map as an educational method with English language learners .
METHODS	English language learner community members ( n = 73 ) were assigned randomly to participate in 1 of 3 experimental conditions : food safety map , cooking class , and control .
METHODS	Participants in the food safety map and cooking class conditions completed a pre-education demographic and cooking history questionnaire , a post-education knowledge and intention questionnaire , and a 2-week post-cooking and food safety habits assessment .
METHODS	Participants in the control group received no educational training but completed the pre - and 2-week post-education assessments .
RESULTS	The cooking class and the map class were both effective in increasing food safety knowledge .
RESULTS	Specifically , by comparing with the control group , they significantly increased participants ' knowledge of safely cooking large meat ( [ df = 2 , n = 66 ] = 40.87 ; P < .001 ; V * = .79 ) and correctly refrigerating cooked food ( [ df = 2 , n = 73 ] = 24.87 , P < .001 ; V * = .58 ) .
RESULTS	The two class types generated similar positive educational effects on boosting food safety behavioral intention ( measured right after the class ) .
RESULTS	The data collected 2 weeks after the classes suggested that individuals who took the classes followed the suggested food behaviors more closely than those in the control group ( P < .01 ) .
CONCLUSIONS	The food safety map is simple to use and prepare , beneficial for oral and visual learners , and inexpensive .
CONCLUSIONS	Compared with a food safety cooking class , the map produces similar learning and behavioral outcomes .

###24674975
OBJECTIVE	Despite a general lack of understanding of the underlying mechanisms , cold water immersion ( CWI ) is widely used by athletes for recovery .
OBJECTIVE	This study examined the physiological merit of CWI for recovery from high-intensity exercise by investigating if the placebo effect is responsible for any acute performance or psychological benefits .
METHODS	Thirty males ( mean SD : age , 24 5 yr ; VO2 peak , 51.1 7.0 mL kg ( -1 ) min ( -1 ) ) performed an acute high-intensity interval training session , comprised of 4 30-s sprints , immediately followed by one of the following three 15-min recovery conditions : CWI ( 10.3 C 0.2 C ) , thermoneutral water immersion placebo ( TWP ) ( 34.7 C 0.1 C ) , or thermoneutral water immersion control ( TWI ) ( 34.7 C 0.1 C ) .
METHODS	An intramuscular thermistor was inserted during exercise and recovery to record muscle temperature .
METHODS	Swelling ( thigh girth ) , pain threshold/tolerance , interleukin 6 concentration , and total leukocyte , neutrophil , and lymphocyte counts were recorded at baseline , postexercise , postrecovery , and 1 , 24 , and 48 h postexercise .
METHODS	A maximal voluntary isometric contraction ( MVC ) of the quadriceps was performed at the same time points , with the exception of postexercise .
METHODS	Self-assessments of readiness for exercise , fatigue , vigor , sleepiness , pain , and belief of recovery effectiveness were also completed .
RESULTS	Leg strength after the MVC and ratings of readiness for exercise , pain , and vigor were significantly impaired in TWI compared with those in CWI and TWP which were similar to each other .
CONCLUSIONS	A recovery placebo administered after an acute high-intensity interval training session is superior in the recovery of muscle strength over 48 h as compared with TWI and is as effective as CWI .
CONCLUSIONS	This can be attributed to improved ratings of readiness for exercise , pain , and vigor , suggesting that the commonly hypothesized physiological benefits surrounding CWI are at least partly placebo related .

###25422827
OBJECTIVE	To compare the clinical effectiveness of two implant systems : Way Milano and Kentron ( Geass , Pozzuolo del Friuli , UD , Italy ) .
METHODS	A total of 64 patients requiring at least two single crowns or partial fixed dental prostheses supported by a maximum of three implants had their sites randomised according to a split-mouth design to receive both implant systems at six centres .
METHODS	Patients were followed up for 1 year after initial loading .
METHODS	Outcome measures were : prosthesis/implant failures ; any complication ; peri-implant marginal bone level changes ; and clinician preference .
RESULTS	In total 71 Way Milano and 73 Kentron implants were placed .
RESULTS	Six patients dropped-out before the 1-year follow-up , but all remaining patients were followed up to 1 year post-loading .
RESULTS	No Way Milano implant failed , whereas three Kentron implants failed before loading .
RESULTS	Two complications were reported , one for each implant type .
RESULTS	There were no statistically significant differences for prosthesis/implant failures ( difference in proportions = 0.05 , P = 0.25 ; 95 % CI -0.02 to 0.13 ) and complications ( difference in proportions = 0 , P = 1.0 , 95 % CI -0.07 to 0.07 ) between the implant systems .
RESULTS	Three operators preferred Way Milano implants whereas the other three had no preference .
RESULTS	At implant placement ( baseline ) bone levels were higher for Way Milano implants ( 0.27 mm ) than for Kentron implants ( 0.41 mm ) .
RESULTS	Both groups gradually lost statistically significant amounts of periimplant marginal bone at 4 months after loading and at 1 year after loading .
RESULTS	One year after loading , Way Milano implants lost an average of 0.73 mm peri-implant bone compared with 0.84 mm of Kentron implants .
RESULTS	Marginal bone level changes were not statistically significant different for Way Milano compared to Kentron implants at 4 months ( -0.16 mm , 95 % CI -0.30 , 0.01 ; P = 0.0606 ) and 1 year ( -0.09 mm , 95 % CI -0.26 , 0.09 ; P = 0.3407 ) after loading .
CONCLUSIONS	No statistically significant differences were observed between the two implant types , although three Kentron implants failed versus none of the Way Milano type .
CONCLUSIONS	Longer follow-up of wider patient populations are needed to better understand whether there is an effective advantage with one of the two implant designs .

###25711321
OBJECTIVE	The risks and benefits of initiating antiretroviral treatment ( ART ) at high CD4 cell counts have not been reliably quantified .
OBJECTIVE	The Strategic Timing of AntiRetroviral Treatment ( START ) study is a randomized international clinical trial that compares immediate with deferred initiation of ART for HIV-positive individuals with CD4 cell counts above 500cells/L .
OBJECTIVE	We describe the demographics , HIV-specific characteristics and medical history of this cohort .
METHODS	Data collected at baseline include demographics , HIV-specific laboratory values , prior medical diagnoses and concomitant medications .
METHODS	Baseline characteristics were compared by geographical region , gender and age .
RESULTS	START enrolled 4685 HIV-positive participants from 215 sites in 35 countries .
RESULTS	The median age is 36 years [ interquartile range ( IQR ) 29-44 years ] , 27 % are female , and 45 % self-identify as white , 30 % as black , 14 % as Latino/Hispanic , 8 % as Asian and 3 % as other .
RESULTS	The route of HIV acquisition is reported as men who have sex with men in 55 % of participants , heterosexual sex in 38 % , injecting drug use in 1 % and other/unknown in 5 % .
RESULTS	Median time since HIV diagnosis is 1.0 year ( IQR 0.4-3 .0 years ) and the median CD4 cell count and HIV RNA values at study entry are 651cells/L ( IQR 584-765cells / L ) and 12,754 HIV RNA copies/mL ( IQR 3014-43 ,607 copies/mL ) , respectively .
CONCLUSIONS	START has enrolled a diverse group of ART-nave individuals with high CD4 cell counts who are comparable to the HIV-positive population from the regions in which they were enrolled .
CONCLUSIONS	The information collected with this robust study design will provide a database with which to evaluate the risks and benefits of early ART use for many important outcomes .

###24884585
BACKGROUND	Umbilical cord blood ( UCB ) is an important source of hematopoietic stem cells ( HSCs ) .
BACKGROUND	However , the concentration of cells in cord blood units is limited and this may represent the main restriction to their therapeutic clinical use .
BACKGROUND	The percentage of metabolically active stem cells provides a measure of the viability of cells in an UCB sample .
BACKGROUND	It follows that an active cellular metabolism causes a proliferation in stem cells , offering an opportunity to increase the cellular concentration .
BACKGROUND	A high cell dose is essential when transplanting cord stem cells , guaranteeing , in the receiving patient , a successful outcome.This study is designed to evaluate the impact of docosahexaenoic acid ( DHA ) supplementation in pregnant women , in order to increase the quantity and viability of the cells in UCB samples .
METHODS	The metabolic demand of DHA increases in the course of pregnancy and reaches maximum absorption during the third trimester of pregnancy .
METHODS	According to these observations , this trial will be divided into two different experimental groups : in the first group , participants will be enrolled from the 20th week of estimated stage of gestation , before the maximum absorption of DHA ; while in the second group , enrolment will start from the 28th week of estimated stage of gestation , when the DHA request is higher .
METHODS	Participants in the trial will be divided and randomly assigned to the placebo group or to the experimental group .
METHODS	Each participant will receive a complete set of capsules of either placebo ( 250 mg of olive oil ) or DHA ( 250 mg ) , to take one a day from the 20th or from the 28th week , up to the 40th week of estimated gestational age .
METHODS	Samples of venous blood will be taken from all participants before taking placebo or DHA , at the 20th or at the 28th week , and at the 37th to 38th week of pregnancy to monitor the level of DHA .
METHODS	Cell number and cellular viability will be evaluated by flow cytometry within 48 hours of the UCB sample collection .
BACKGROUND	International Standard Randomised Controlled Trial Number Register : ISRCTN58396079 .
BACKGROUND	Registration date : 8 October 2013 .

###24262217
BACKGROUND	Hotel-based sex workers in Bangladesh have high rates of sexually transmissible infections ( STIs ) , high client turnover and low condom use .
BACKGROUND	Two monthly clinic-based strategies were compared : periodic presumptive treatment ( PPT ) and enhanced syndromic management ( ESM ) - one round of presumptive treatment followed by treatment based on assessment and laboratory tests .
METHODS	A randomised controlled trial compared PPT and ESM by prevalence and incidence , behaviour , retention , cost and STI incidence and prevalence .
METHODS	Demographic , behavioural and clinical data were collected from women at two clinics in Dhaka .
METHODS	All women received presumptive treatment and were randomised to receive PPT or ESM at nine monthly visits .
RESULTS	In total , 549 women ( median age : < 20 years ) were enrolled .
RESULTS	At baseline , the prevalence of chlamydia ( Chlamydia trachomatis ) and gonorrhoea ( Neisseria gonorrhoeae ) was 41 % ( ESM : 41 % ; PPT : 42 % ) .
RESULTS	After 9 months , chlamydia and gonorrhoea decreased to 7 % overall , ( ESM : 7.4 % ; PPT : 6.8 % ) .
RESULTS	At each visit , 98 % of women receiving ESM met the therapy criteria and were treated .
RESULTS	Retention was low ( 50 % ) .
RESULTS	Total costs were 50 % lower per visit for each woman for PPT ( ESM : $ 11.62 v. PPT : $ 5.80 ) .
RESULTS	The number of sex work sessions was reduced from 3.3 to 2.5 ( P < 0.001 ) , but income did not change .
RESULTS	Coercion was reduced but condom use at last sex did not change significantly .
CONCLUSIONS	Monthly PPT and ESM were effective approaches for STI control .
CONCLUSIONS	PPT offered a feasible , low-cost alternative to ESM .
CONCLUSIONS	Educational aspects led to a reduction in coercion and fewer sessions .
CONCLUSIONS	Implementation studies are needed to improve condom use and retention .

###24528604
BACKGROUND	Due to fragmented mental , somatic , and social healthcare services , it can be hard to engage into care older patients with severe mental illness ( SMI ) .
BACKGROUND	In adult mental health care , assertive community treatment ( ACT ) is an organizational model of care for treating patients with SMI who are difficult to engage .
BACKGROUND	So far all outcome studies of assertive community treatment have been conducted in adults .
METHODS	In a randomized controlled trial design we compared the effectiveness of ACT for elderly patients with that of treatment as usual ( TAU ) .
METHODS	Sixty-two outpatients ( 60 years and older ) with SMI who were difficult to engage in psychiatric treatment were randomly assigned to the intervention or control group ( 32 to ACT for elderly patients and 30 to TAU ) .
METHODS	Primary outcomes included number of patients who had a first treatment contact within 3 months , the number of dropouts ( i.e. those discharged from care due to refusing care or those who unintentionally lost contact with the service over a period of at least 3 months ) ; and patients ' psychosocial functioning ( HoNOS65 + scores ) during 18 months follow-up .
METHODS	Secondary outcomes included the number of unmet needs and mental health care use .
METHODS	Analyses were based on intention-to-treat .
RESULTS	Of the 62 patients who were randomized , 26 were lost to follow-up ( 10 patients in ACT for elderly patients and 16 in TAU ) .
RESULTS	Relative to patients with TAU , more patients allocated to ACT had a first contact within three months ( 96.9 versus 66.7 % ; X2 ( df = 1 ) = 9.68 , p = 0.002 ) .
RESULTS	ACT for elderly patients also had fewer dropouts from treatment ( 18.8 % of assertive community treatment for elderly patients versus 50 % of TAU patients ; X2 ( df = 1 ) = 6.75 , p = 0.009 ) .
RESULTS	There were no differences in the other primary and secondary outcome variables .
CONCLUSIONS	These findings suggest that ACT for elderly patients with SMI engaged patients in treatment more successfully .
BACKGROUND	NTR1620 .

###25293644
OBJECTIVE	The aim of this study was to analyse effects of a comprehensive continuum of care ( intervention group ) on frail older persons ' life satisfaction , as compared to those receiving usual care ( control group ) .
OBJECTIVE	The intervention included geriatric assessment , case management , interprofessional collaboration , support for relatives and organising of care-planning meetings in older persons ' own homes .
BACKGROUND	Improvements in older persons ' subjective well-being have been shown in studies including care planning and coordination by a case manager .
BACKGROUND	However , effects of more complex continuum of care interventions on frail older persons ' life satisfaction are not well explored .
METHODS	Randomised controlled study .
METHODS	The validated LiSat-11 scale was used in face-to-face interviews to assess older persons ' life satisfaction at baseline and at three , six and 12 months after the baseline .
METHODS	The odds ratio for improving or maintaining satisfaction was compared for intervention and control groups from baseline to three-month , three - to six-month as well as six - to 12-month follow-ups .
RESULTS	Older persons who received the intervention were more likely to improve or maintain satisfaction than those who received usual care , between 6 and 12 month follow-ups , for satisfaction regarding functional capacity , psychological health and financial situation .
CONCLUSIONS	A comprehensive continuum of care intervention comprising several components had a positive effect on frail older persons ' satisfaction with functional capacity , psychological health and financial situation .
CONCLUSIONS	Frail older persons represent a great proportion of the persons in need of support from the health care system .
CONCLUSIONS	Health care professionals need to consider continuum of care interventions ' impact on life satisfaction .
CONCLUSIONS	As life satisfaction is an essential part of older persons ' well-being , we propose that policy makers and managers promote comprehensive continuum of care solutions .

###25488124
OBJECTIVE	To evaluate the changes of vascular endothelial growth factor ( VEGF ) plasma levels after intravitreal injections of aflibercept or ranibizumab in patients with exudative age-related macular degeneration ( AMD ) .
METHODS	Thirty-eight patients with exudative AMD were included in this randomised , prospective study .
METHODS	Nineteen patients were randomised to treatment with intravitreal aflibercept ( 2.0 mg ) and 19 to intravitreal ranibizumab ( 0.5 mg ) .
METHODS	The concentration of VEGF was measured by ELISA just before the injection , after 7 days and 1 month .
METHODS	Twenty-two age - and sex-matched healthy patients without chorioretinal diseases served as control .
RESULTS	The median baseline plasma VEGF concentration was 61.0 pg/ml in the control group , 43.0 pg/ml in the aflibercept group and 59.0 pg/ml in the ranibizumab group ( p = 0.127 ) .
RESULTS	Seven days after intravitreal injection of aflibercept plasma levels were significantly reduced to values below the minimum detectable dose ( MDD ) in 17 of 19 patients ( 89.5 % ) resulting in a median VEGF concentration of < 9 pg/ml ( p < 0.001 ) .
RESULTS	The reduction persisted throughout 1 month with values below the MDD in 5 of 19 patients ( 26.3 % ) and a median measurement of 17.0 pg/ml ( p < 0.001 ) .
RESULTS	In patients treated with ranibizumab no significant effects could be observed with a baseline VEGF of 59.0 pg/ml , 54.0 pg/ml at 7 days ( p = 0.776 ) and 58.5 pg/ml at 4 weeks of follow-up ( p = 0.670 ) .
CONCLUSIONS	After intravitreal aflibercept injection , the systemic VEGF levels were significantly reduced throughout the observational period of 4 weeks .
CONCLUSIONS	No significant systemic effects of intravitreal ranibizumab on plasma VEGF were observed .

###24813670
BACKGROUND	A substantial minority of adolescents suffer from depression and it is associated with increased risk of suicide , social and educational impairment , and mental health problems in adulthood .
BACKGROUND	A recently conducted randomized controlled trial in England evaluated the effectiveness of a manualized universally delivered age-appropriate CBT programme in school classrooms .
BACKGROUND	The cost-effectiveness of the programme for preventing low mood and depression for all participants from a health and social care sector perspective needs to be determined .
METHODS	A trial-based cost-effectiveness analysis based on a cluster-randomized controlled trial ( trial registration -- ISRCTN 19083628 ) comparing classroom-based CBT with usual school provision of Personal Social and Health Education .
METHODS	Per-student cost of intervention was estimated from programme records .
METHODS	The study was undertaken in eight mixed-sex U.K. secondary schools , and included 3,357 school children aged 12 to 16 years ( in the two trial arms evaluated in the cost-effectiveness analysis ) .
METHODS	The main outcome measures were individual self-reported data on care costs , Quality-Adjusted Life-Years ( QALYs , based on the EQ-5D health-related quality-of-life instrument ) and symptoms of depression ( Short Mood and Feelings Questionnaire ) at baseline , 6 and 12 months .
RESULTS	Although there was lower quality-adjusted life-years over 12 months ( -.05 QALYs per person , 95 % confidence interval -.09 to -.005 , p = .03 ) with CBT , this is a ` clinically ' negligible difference , which was not found in the complete case analyses .
RESULTS	There was little evidence of any between-arm differences in SMFQ scores ( 0.19 , 95 % CI -0.57 to 0.95 , p = .62 ) , or costs ( 142 , 95 % CI -132 to 415 , p = .31 ) per person for CBT versus usual school provision .
CONCLUSIONS	Our analysis suggests that the universal provision of classroom-based CBT is unlikely to be either more effective or less costly than usual school provision .

###24346155
OBJECTIVE	We investigated atorvastatin reloading effects on endothelial progenitor cell ( EPC ) count and inflammatory cytokine expression after percutaneous coronary intervention ( PCI ) in patients with stable angina pectoris who had previously received long-term statin treatments .
METHODS	Patients with stable angina pectoris were treated with 80 mg atorvastatin 12 hours and 40 mg atorvastatin 2 hours before coronary angioplasty ( n = 15 ) or preoperatively with 40 mg/d atorvastatin for 7 days ( n = 15 ) or did not receive atorvastatin ( n = 15 ) .
METHODS	CD45 - / 133 + / 34 + , CD45 - / CD34 + / kinase insert domain receptor ( KDR ) + , and CD45 - / CD144 + / KDR + EPCs in the peripheral blood were determined by flow cytometry 1 hour before as well as 1 hour , 6 hours , and 24 hours after PCI .
METHODS	Soluble intercellular adhesion molecule 1 ( sICAM-1 ) , hypersensitive C-reactive protein ( hCRP ) , and troponin-I ( TnI ) serum concentrations were analyzed immediately prior to and 24 hours after PCI .
RESULTS	In the 40mg Atorvastatin and control groups , none of the analyzed EPC blood concentrations changed significantly from 1h before operation to 1h and 6 h postoperative values .
RESULTS	In contrast , the number of circulating early differentiation stage EPCs CD45 - / 133 + / 34 + and CD45 - / CD34 + / KDR + raised significantly from 1 h preoperative values ( 57.39.3 ; 57.3 10.7 ) to 1 h postoperative ( ( 74.4 11.4 ; 78.8 16.2 ) , ( p < 0.05 ) ) and 6 h postoperative ( ( 93 16.9 ; 99.7 11.9 ) , ( p < 0.05 ) ) concentrations after coronary angioplasty in the 80mg Atorvastatin medication patients .
RESULTS	In the control group , the sICAM-1 ( 174.55 38.91 vs 204.11 58.24 ) and hCRP ( 1.89 1.93 vs 9.0 11.1 ) serum concentrations at 24 hours after PCI were significantly elevated ( P < .05 ) compared to preoperative values , whereas the increases in the 2 groups treated with atorvastatin were not significant .
RESULTS	In addition , the rise in serum TnI concentration level from pre - to postoperative in the 80-mg ( 0.02 0.02 vs 0.09 0.08 ) and the 40-mg ( 0.01 0.03 vs 1.2 2.59 ) reloading groups was less than that of the controls ( 0.01 0.02 vs 1.75 3.09 ) ( p < 0.05 ) .
CONCLUSIONS	Our results suggested that high-dose atorvastatin application before PCI triggered early EPC circulation .
CONCLUSIONS	Furthermore , postoperative inflammatory cytokine sICAM-1 as well as hCRP serum levels were reduced , while postinterventional myocardial injury marker TnI elevations were inversely correlated with statin reloadings .

###24440167
BACKGROUND	Airway inflammation , mediated in part by LTB4 , contributes to lung destruction in patients with cystic fibrosis ( CF ) .
BACKGROUND	LTB ( 4 ) - receptor inhibition may reduce airway inflammation .
BACKGROUND	We report the results of a randomized , double-blind , placebo-controlled study of the efficacy and safety of the leukotriene B ( 4 ) ( LTB ( 4 ) ) - receptor antagonist BIIL 284 BS in CF patients .
METHODS	CF patients aged 6 years with mild to moderate lung disease were randomized to oral BIIL 284 BS or placebo once daily for 24 weeks .
METHODS	Co-primary endpoints were change in FEV ( 1 ) and incidence of pulmonary exacerbation .
RESULTS	After 420 ( 155 children , 265 adults ) of the planned 600 patients were randomized , the trial was terminated after a planned interim analysis revealed a significant increase in pulmonary related serious adverse events ( SAEs ) in adults receiving BIIL 284 BS .
RESULTS	Final analysis revealed SAEs in 36.1 % of adults receiving BIIL 284 BS vs. 21.2 % receiving placebo ( p = 0.007 ) , and in 29.6 % of children receiving BIIL 284 BS vs. 22.9 % receiving placebo ( p = 0.348 ) .
RESULTS	In adults , the incidence of protocol-defined pulmonary exacerbation was greater in those receiving BIIL 284 BS than in those receiving placebo ( 33.1 % vs. 18.2 % respectively ; p = 0.005 ) .
RESULTS	In children , the incidence of protocol-defined pulmonary exacerbation was 19.8 % in the BIIL 284 BS arm , and 25.7 % in the placebo arm ( p = 0.38 ) .
CONCLUSIONS	While the cause of increased SAEs and exacerbations due to BIIL 284 BS is unknown , the outcome of this trial provides a cautionary tale for the administration of potent anti-inflammatory compounds to individuals with chronic infections , as the potential to significantly suppress the inflammatory response may increase the risk of infection-related adverse events .

###24226568
OBJECTIVE	Alopecia areata is an idiopathic cause of hair loss with limited therapeutic repertoire .
OBJECTIVE	To compare the efficacy and safety of a high - vs low-potency topical corticosteroid in pediatric patients .
METHODS	This single-center , randomized , blind , 2-arm , parallel-group , superiority trial was carried out over a 24-week period at a tertiary referral academic dermatology clinic at The Hospital for Sick Children in Toronto , Ontario , Canada .
METHODS	Forty-two children attending the outpatients clinic , 2 to 16 years of age with alopecia areata affecting at least 10 % of scalp surface area , were eligible ; 1 declined to participate .
METHODS	There were no withdrawals from the study .
METHODS	INTERVENTIONS FOR CLINICAL TRIALS : Patients were randomly assigned to receive clobetasol propionate , 0.05 % cream , or hydrocortisone , 1 % , cream .
METHODS	Patients applied a thin layer of the assigned cream twice daily to the areas of hair loss for 2 cycles of 6 weeks on , 6 weeks off , for a total of 24 weeks .
METHODS	The primary outcome was the change in scalp surface area with hair loss over 24 weeks following enrollment .
METHODS	RESULTS All participants were assessed at 6 , 12 , 18 , and 24 weeks ( except 1 participant who missed the 6-week visit ) .
METHODS	After adjusting for baseline hair loss , the clobetasol group had a statistically significant ( P < .001 ) greater decrease in the surface area with hair loss , compared with the hydrocortisone group at all time points except at 6 weeks .
METHODS	One patient with extensive alopecia areata experienced skin atrophy that resolved spontaneously in 6 weeks .
METHODS	There was no difference observed in the number of patients with abnormal urinary cortisol at the beginning and the end of the study .
CONCLUSIONS	Topical clobetasol propionate , 0.05 % , cream is efficacious and safe as a first-line agent for limited patchy childhood alopecia areata .
CONCLUSIONS	TRIAL REGISTRATION clinicaltrials.gov Identifier : NCT01453686 .

###25385735
OBJECTIVE	Given the limited sensitivity and specificity of prostate-specific antigen ( PSA ) , its widespread use as a screening tool has raised concerns for the overdiagnosis of low-risk and the underdiagnosis of high-grade prostate cancer .
OBJECTIVE	To improve early-detection biopsy decisions , the National Cancer Institute conducted a prospective validation trial to assess the diagnostic performance of the prostate cancer antigen 3 ( PCA3 ) urinary assay for the detection of prostate cancer among men screened with PSA .
METHODS	In all , 859 men ( mean age , 62 years ) from 11 centers scheduled for a diagnostic prostate biopsy between December 2009 and June 2011 were enrolled .
METHODS	The primary outcomes were to assess whether PCA3 could improve the positive predictive value ( PPV ) for an initial biopsy ( at a score > 60 ) and the negative predictive value ( NPV ) for a repeat biopsy ( at a score < 20 ) .
RESULTS	For the detection of any cancer , PPV was 80 % ( 95 % CI , 72 % to 86 % ) in the initial biopsy group , and NPV was 88 % ( 95 % CI , 81 % to 93 % ) in the repeat biopsy group .
RESULTS	The addition of PCA3 to individual risk estimation models ( which included age , race/ethnicity , prior biopsy , PSA , and digital rectal examination ) improved the stratification of cancer and of high-grade cancer .
CONCLUSIONS	These data independently support the role of PCA3 in reducing the burden of prostate biopsies among men undergoing a repeat prostate biopsy .
CONCLUSIONS	For biopsy-naive patients , a high PCA3 score ( > 60 ) significantly increases the probability that an initial prostate biopsy will identify cancer .

###25304787
OBJECTIVE	Early laryngeal cancer is usually treated with either transoral laser surgery or radiation therapy .
OBJECTIVE	The quality of voice achieved with these treatments has not been compared in a randomized trial .
METHODS	Male patients with carcinoma limited to 1 mobile vocal cord ( T1aN0M0 ) were randomly assigned to receive either laser surgery ( n = 32 ) or external beam radiation therapy ( n = 28 ) .
METHODS	Surgery consisted of tumor excision with a CO2 laser with the patient under general anaesthesia .
METHODS	External beam radiation therapy to the larynx was delivered to a cumulative dose of 66 Gy in 2-Gy daily fractions over 6.5 weeks .
METHODS	Voice quality was assessed at baseline and 6 and 24 months after treatment .
METHODS	The main outcome measures were expert-rated voice quality on a grade , roughness , breathiness , asthenia , and strain ( GRBAS ) scale , videolaryngostroboscopic findings , and the patients ' self-rated voice quality and its impact on activities of daily living .
RESULTS	Overall voice quality between the groups was rated similar , but voice was more breathy and the glottal gap was wider in patients treated with laser surgery than in those who received radiation therapy .
RESULTS	Patients treated with radiation therapy reported less hoarseness-related inconvenience in daily living 2 years after treatment .
RESULTS	Three patients in each group had local cancer recurrence within 2 years from randomization .
CONCLUSIONS	Radiation therapy may be the treatment of choice for patients whose requirements for voice quality are demanding .
CONCLUSIONS	Overall voice quality was similar in both treatment groups , however , indicating a need for careful consideration of patient-related factors in the choice of a treatment option .

###25214768
BACKGROUND	The current study was conducted to find out whether two oral preparations of 300 mg gabapentin ( the test and reference capsules ) were bioequivalent .
METHODS	This was a randomized , single-blind , crossover study under fasting condition , with a 7-day washout period , which included 37 healthy adult male and female subjects .
METHODS	After an overnight fast , subjects were given , orally , one capsule of the test drug or of the reference drug .
METHODS	Blood samples were drawn immediately before taking the drug , then at 20 and 40 minutes , and 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 10 , 12 , 15 , and 24 hours after dosing , to evaluate pharmacokinetic parameters of the single dose administration , ie , the area under the plasma concentration-time curve ( AUC ) from time zero to 24 hours ( AUCt ) , AUC from time zero to infinity ( AUC ( inf ) ) , the peak plasma concentration of the drug ( Cmax ) , time needed to achieve Cmax ( tmax ) , and the elimination half-life ( t1/2 ) .
METHODS	The plasma concentrations of gabapentin were determined using validated high-performance liquid chromatography with ultraviolet detection .
RESULTS	The geometric mean ratios ( 90 % confidence interval ) of the test drug/reference drug for gabapentin were 103.15 % ( 90.38 % -117.72 % ) for AUCt , 103.53 % ( 90.78 % -118.07 % ) for AUC ( inf ) , and 108.06 % ( 96.32 % -121.24 % ) for Cmax .
RESULTS	The differences in tmax and t1/2 values between the test and reference drug products for gabapentin were not statistically significant .
RESULTS	Light-headedness , nausea , and headache were encountered during the study , but they were all mild and well tolerated .
RESULTS	The 90 % confidence intervals of the test/reference AUC ratio and Cmax ratio of gabapentin were within the acceptance range for bioequivalence .
CONCLUSIONS	The two preparations of gabapentin 300 mg capsule were bioequivalent , thus both can be used interchangeably in the clinical setting .

###25391305
OBJECTIVE	We investigated the effects of 2-year folic acid and vitamin B12 supplementation on cognitive performance in elderly people with elevated homocysteine ( Hcy ) levels .
METHODS	This multicenter , double-blind , randomized , placebo-controlled trial included 2,919 elderly participants ( 65 years and older ) with Hcy levels between 12 and 50 mol/L .
METHODS	Participants received daily either a tablet with 400 g folic acid and 500 g vitamin B12 ( B-vitamin group ) or a placebo tablet .
METHODS	Both tablets contained 15 g vitamin D3 .
METHODS	Data were available for global cognitive functioning assessed by Mini-Mental State Examination ( n = 2,556 ) , episodic memory ( n = 2,467 ) , attention and working memory ( n = 759 ) , information processing speed ( n = 731 ) , and executive function ( n = 721 ) .
RESULTS	Mean age was 74.1 ( SD 6.5 ) years .
RESULTS	Hcy concentrations decreased 5.0 ( 95 % confidence interval -5.3 to -4.7 ) mol/L in the B-vitamin group and 1.3 ( -1.6 to -0.9 ) mol/L in the placebo group .
RESULTS	Cognitive domain scores did not differ over time between the 2 groups , as determined by analysis of covariance .
RESULTS	Mini-Mental State Examination score decreased with 0.1 ( -0.2 to 0.0 ) in the B-vitamin group and 0.3 ( -0.4 to -0.2 ) in the placebo group ( p = 0.05 ) , as determined by an independent t test .
CONCLUSIONS	Two-year folic acid and vitamin B12 supplementation did not beneficially affect performance on 4 cognitive domains in elderly people with elevated Hcy levels .
CONCLUSIONS	It may slightly slow the rate of decline of global cognition , but the reported small difference may be attributable to chance .
METHODS	This study provides Class I evidence that 2-year supplementation with folic acid and vitamin B12 in hyperhomocysteinemic elderly people does not affect cognitive performance .

###24998880
BACKGROUND	Fluticasone furoate/vilanterol ( FF/VI ) is an inhaled corticosteroid/long-acting beta2-agonist ( ICS/LABA ) , recently approved as once-daily maintenance therapy for COPD .
BACKGROUND	We compared the lung function effects of FF/VI with those of twice-daily fluticasone propionate/salmeterol ( FP/SAL ) .
METHODS	Three 12 week studies comparing FF/VI and FP/SAL were conducted .
METHODS	Patients aged 40 years with moderate-to-very severe COPD were randomized to receive double-blind , double-dummy FF/VI 100/25 mcg once-daily , or FP/SAL 250/50 mcg twice-daily for 12 weeks following a 2 week placebo run-in period .
METHODS	The primary endpoint of each study was change from baseline trough in 0-24 h weighted mean FEV ( 1 ) ( wmFEV ( 1 ) ) on Day 84 .
METHODS	Safety was also assessed .
RESULTS	In Study 1 ( HZC113109 ) ( intent-to-treat n : FF/VI = 260 ; FP/SAL = 259 ) , the increase from baseline in 0-24 h wmFEV ( 1 ) was significantly greater with FF/VI than FP/SAL ( 80 mL , P < 0.001 ) .
RESULTS	In Study 2 ( HZC112352 ) ( intent-to-treat n : FF/VI = 259 ; FP/SAL = 252 ) and Study 3 ( RLV116974 ) ( intent-to-treat n : FF/VI = 412 ; FP/SAL = 416 ) , the increase from baseline in 0-24 h wmFEV ( 1 ) was not significantly greater with FF/VI than FP/SAL ( 29 mL , P = 0.267 ; 25 mL , P = 0.137 ) .
RESULTS	The treatment difference was statistically but not clinically significant in a pooled analysis ( 41 mL , P < 0.001 ) .
RESULTS	Pooled adverse events ( FF/VI 27 % ; FP/SAL 28 % ) and serious adverse events ( FF/VI 2 % ; FP/SAL 3 % ) were similar between treatments .
CONCLUSIONS	Our data suggest that once-daily FF/VI 100/25 mcg provides FEV ( 1 ) improvement in COPD that is at least comparable with that conferred by twice-daily FP/SAL 250/50 mcg , although interpretation is limited by differences in individual study outcomes .
CONCLUSIONS	The safety profiles of FF/VI 100/25 mcg and FP/SAL 250/50 mcg are similar .
BACKGROUND	clinicaltrials.gov : NCT01323634 ; NCT01323621 ; NCT01706328 .
BACKGROUND	GlaxoSmithKline study codes : HZC113109 ; HZC112352 ; RLV116974 .

###24670418
OBJECTIVE	Atrial fibrillation ( AF ) is common in dialysis patients and is associated with increased morbidity and mortality .
OBJECTIVE	The pathophysiology may be related to common risk factors for both AF and renal disease or to dialysis-specific factors .
OBJECTIVE	The purpose of this study was to determine whether and how AF onset relates to the dialysis procedure itself .
METHODS	All dialysis patients enrolled in the implantable cardioverter defibrillator-2 ( ICD-2 ) trial until January 2012 , who were implanted with an ICD , were included in this study .
METHODS	Using the ICD remote monitoring function , the exact time of onset of all AF episodes was registered .
METHODS	Subsequently , this was linked to the timing of dialysis procedures .
RESULTS	For the current study , a total of 40 patients were included , follow-up was 28 16 months , 80 % male , 70 8 years old .
RESULTS	A total of 428 episodes of AF were monitored in 14 patients .
RESULTS	AF onset was more frequent on the days of haemodialysis ( HD ) ( p < 0.001 ) and specifically increased during the dialysis procedure itself ( p = 0.04 ) .
RESULTS	Patients with AF had a larger left atrium ( p < 0.001 ) and a higher systolic blood pressure before and after HD ( p < 0.001 ) .
CONCLUSIONS	This study provides insight in the exact timing of AF onset in relation to the dialysis procedure itself .
CONCLUSIONS	In HD patients , AF occurred significantly more often on a dialysis day and especially during HD .
CONCLUSIONS	These findings might help to elucidate some aspects of the pathophysiology of AF in dialysis patients and could facilitate early detection of AF in these high-risk patients .

###24418526
OBJECTIVE	Low dose computerised tomography ( CT ) screening for lung cancer can reduce lung-cancer-specific mortality .
OBJECTIVE	The objective of this study was to analyse healthcare costs and healthcare utilisation of participants in the Danish lung cancer CT-screening trial ( DLCST ) .
METHODS	This registry study was nested in a randomised controlled trial ( DLCST ) .
METHODS	4104 participants , current or former heavy smokers , aged 50-70 years were randomised to five annual low dose CT scans or usual care during 2004-2010 .
METHODS	Total healthcare costs and healthcare utilisation data for both the primary and the secondary healthcare sector were retrieved from public registries from randomisation - September 2011 and compared between ( 1 ) the CT-screening group and the control group and , ( 2 ) the control group and each of the true-positive , false-positive and true-negative groups .
RESULTS	The median annual costs per participant were significantly higher in the CT-screening group ( Euros [ EUR ] 1342 , interquartile range [ IQR ] 750-2980 ) compared with the control group ( EUR 1190 , IQR 590-2692 ) ( p < 0.0001 ) .
RESULTS	When the cost of the CT-screening programme was excluded , there was no longer a statistically significant difference between the CT-screening group ( EUR 1155 , IQR 567-2798 ) and the control group ( p = 0.52 ) .
RESULTS	Analyses according to the diagnostic groups showed that annual costs were 10.57 ( 95 % CI 7.09-15 .75 ) times higher for the true-positive and 1.67 ( 95 % CI 1.20-2 .32 ) times higher for the false-positive group compared with the control group .
CONCLUSIONS	Low dose lung cancer CT screening increases healthcare costs compared with no screening ; this difference was attributable to the costs of the CT-screening programme .
CONCLUSIONS	Overall healthcare costs were higher for the true-positive and false-positive groups than for the control group , also when excluding the cost of the CT-screening programme .
CONCLUSIONS	This increase was outweighed by the larger true-negative group showing no significant differences in costs compared with the control group .

###24503910
OBJECTIVE	The purpose of this study was to investigate whether individualized deliberate practice on a virtual reality ( VR ) simulator results in improved technical performance in the operating room .
BACKGROUND	Training on VR simulators has been shown to improve technical performance in the operating room ( OR ) .
BACKGROUND	Currently described VR curricula consist of trainees practicing the same tasks until expert proficiency is reached .
BACKGROUND	It has yet to be investigated whether the individualized deliberate practice , where curricula tasks vary depending on prior levels of technical proficiency , would translate into the OR .
METHODS	This single-blinded prospective trial randomized 16 novice surgical residents to a deliberate practice ( DP ) group and a conventional residency training group .
METHODS	Both groups performed a laparoscopic cholecystectomy in the OR that was video-recorded .
METHODS	Technical performance of DP group residents in the OR was assessed using 3 validated assessment tools .
METHODS	A score of less than 60 % on any component of the assessment tool resulted in the trainee practicing a specific task on the VR simulator .
METHODS	The DP group practiced on the simulator as per their individualized schedule .
METHODS	Both groups then performed another laparoscopic cholecystectomy .
METHODS	A blinded expert assessed the OR recordings using a validated global rating scale .
RESULTS	Although both groups had similar technical abilities preintervention [ DP : median score , 13.5 ( 9.3-15 .0 ) ; control : median score , 14.5 ( 9.3-17 .8 ) ; P = 0.45 ] , the DP residents had a superior technical performance postintervention [ DP : median score , 17.0 ( 15.3-18 .5 ) ; control : median score , 12.5 ( 7.5-14 .0 ) ; P = 0.03 ] .
RESULTS	Of 8 DP residents , 6 practiced 5 basic VR tasks ( median 1 trial to pass ) , and 7 of 8 practiced 2 advanced tasks ( median 4 trials to pass ) .
CONCLUSIONS	A curriculum of deliberate individualized practice on a VR simulator improves technical performance in the OR .
CONCLUSIONS	This has implications to greatly improve the feasibility of implementing simulation-based curricula in residency training programs , rather then having them being limited to research protocols .

###24368615
BACKGROUND	A 16-week lunchtime walking intervention was designed to increase physical activity in physically inactive University employees .
BACKGROUND	The program was delivered and monitored twice over 7 months to examine feasibility across different seasons .
METHODS	Seventy-five participants ( n = 69 females , n = 6 males ; mean age = 47.68 ) were randomly allocated into a Winter ( February start ) or Spring group ( May start ) .
METHODS	Participants were asked to complete 3 weekday lunchtime walks and 2 weekend walks .
METHODS	Weeks 1 to 10 were led by walk leaders ( group phase ) while the participants self-organized their walks during weeks 11 to 16 ( independent phase ) .
METHODS	Yamax pedometers recorded daily step counts and walk group leaders recorded participant attendance in the group phase .
METHODS	Acceptability was assessed via a satisfaction survey and 2 focus groups with participants .
RESULTS	A participant pool representative by ethnicity , but not gender was recruited using a range of strategies .
RESULTS	The program demonstrated good retention across both groups ( 73 % ) .
RESULTS	The intervention was acceptable to participants .
RESULTS	More steps were accumulated in the group-led versus the independent phase .
CONCLUSIONS	The intervention is feasible in this workplace setting across different seasonal periods .
CONCLUSIONS	In the future , researchers should examine if the findings can be replicated in a definitive trial and generalize to other workplace settings .

###24315882
OBJECTIVE	Ramosetron , a serotonin ( 5-hydroxytryptamine ) -3 receptor antagonist with high selectivity , reduced stress-induced diarrhea and defecation caused by corticotropin-releasing hormone in rats .
OBJECTIVE	However , there have been no clinical trials of its effect in patients with diarrhea and irritable bowel syndrome ( IBS-D ) .
OBJECTIVE	We performed a randomized , double-blind , placebo-controlled trial to determine whether ramosetron reduces diarrhea in these patients .
METHODS	Our study included 296 male outpatients with IBS-D treated at 52 centers in Japan .
METHODS	Patients were given 5 g oral ramosetron ( n = 147 ) or placebo ( n = 149 ) once daily for 12 weeks after a 1-week baseline period .
METHODS	The primary end point was increased stool consistency in the first month .
METHODS	Secondary end points included relief of overall IBS symptoms and increased IBS-related quality of life .
RESULTS	More patients given ramosetron ( 74 , 50.3 % ) than those given placebo ( 29 , 19.6 % ) reported improved stool consistency in the first month ( P < .001 ) .
RESULTS	The relative risk and number needed to treat were 2.57 ( 95 % confidence interval , 1.79-3 .70 ) and 3.25 ( 95 % confidence interval , 2.44-4 .89 ) , respectively .
RESULTS	The ramosetron group had significantly higher monthly rates of relief of overall IBS symptoms and IBS-related quality of life than the placebo group .
CONCLUSIONS	Ramosetron ( 5 g oral , once daily for 12 weeks ) improved stool consistency in male patients with IBS-D , compared with placebo .
CONCLUSIONS	These study results , along with the pharmacologic profile of ramosetron , indicate that increased stool consistency is the best end point for studies of ramosetron in patients with IBS-D .
CONCLUSIONS	Clinicaltrials.gov No , NCT01225237 .

###25060541
BACKGROUND	Formoterol fumarate ( FF ) is a well-established long-acting 2-agonist .
BACKGROUND	This represents the first clinical study of FF in a metered-dose inhaler ( FF MDI ) based on proprietary lipid-based porous-particle engineering technology .
METHODS	In this randomized , double-blind , 5-period , crossover study ( NCT00880490 ) , subjects received 2.4 , 4.8 , and 9.6 g of FF MDI , open-label Foradil ( ) Aerolizer ( ) ( FA ) 12g , and placebo .
METHODS	Spirometry was performed at baseline , 15 and 30min , and 1 , 2 , 4 , 6 , 8 , 10 , 11.5 , and 12h post-dose .
RESULTS	Thirty-four subjects were enrolled .
RESULTS	Improvement in forced expiratory volume in 1s ( FEV1 ) was similar between FF MDI 9.6 g and FA .
RESULTS	Change in FEV1 area under the curve for 0-12h ( AUC0-12 ) for each FF MDI dose demonstrated superior efficacy versus placebo ( P < .001 for all 3 doses ) .
RESULTS	Over 12h and at each time point , FF MDI 9.6 g was non-inferior to FA for FEV1 AUC0-12 with the 95 % CI 's supporting a maximum difference of approximately 45mL .
RESULTS	Peak and trough FEV1 , forced vital capacity , peak expiratory flow rate , peak inspiratory capacity , and pharmacokinetics confirmed the primary endpoint , with dose ordering of the FF MDI 2.4 , 4.8 , and 9.6 g , and comparability of FF MDI 9.6 g to FA .
RESULTS	All 3 doses of FF MDI were safe and well-tolerated , with a safety profile similar to that of placebo and FA .
CONCLUSIONS	The efficacy and pharmacokinetic profile of FF MDI 9.6 g were comparable to FA 12g and with similar safety to placebo and FA .
BACKGROUND	This clinical trial was registered on ClinicalTrials.gov , Identifier : NCT NCT00880490 .

###25370889
OBJECTIVE	Fatigue is a common problem among multiple myeloma ( MM ) patients .
OBJECTIVE	Armodafinil is a drug known to promote wakefulness , which is related to modafinil , a compound that improves fatigue in some cancer patients treated with chemotherapeutic agents .
OBJECTIVE	We investigated whether armodafinil could reduce cancer-related fatigue in MM patients .
METHODS	This double-blind , placebo-controlled phase 3 trial evaluated the efficacy of armodafinil in MM patients with evidence of moderate fatigue .
METHODS	Patients were randomized to one of two arms : treatment-only , with armodafinil given at 150 mg/daily for 56 days , or placebo-first , with placebo given on days 1-28 , followed by armodafinil administered at 150 mg daily on days 29-56 .
METHODS	Fatigue was measured on days 1 ( pre-dose : baseline ) , 15 , 28 , 43 , and 56 using seven separate assessments , including four patient-reported outcomes of fatigue and related quality of life measures , as well as three objective measures of cognitive function .
RESULTS	Overall toxicities were similar between treatment groups .
RESULTS	No significant differences were observed between the placebo-first and the treatment-only arms after 28 days .
RESULTS	Treatment with armodafinil for 28 additional days did not produce responses .
RESULTS	Both placebo-first and treatment-only patients showed similar significant improvements in three patient-reported measures and one objective task at day 28 compared to baseline .
RESULTS	Placebo-first patients improved on eight additional measures ( one patient-reported measure , six subscales , and one objective task ) , suggesting a strong placebo effect in this patient population .
CONCLUSIONS	Evaluation and treatment of cancer-related fatigue continues to be challenging ; a clear definition of this symptom and better assessment tools are needed .

###25017822
OBJECTIVE	Opportunistic brief in-person emergency department ( ED ) interventions can be effective at reducing hazardous alcohol use in young adult drinkers , but require resources frequently unavailable .
OBJECTIVE	Mobile telephone text messaging ( short message service [ SMS ] ) could sustainably deliver behavioral support to young adult patients , but efficacy remains unknown .
OBJECTIVE	We report 3-month outcome data of a randomized controlled trial testing a novel SMS-delivered intervention in hazardous-drinking young adults .
METHODS	We randomized 765 young adult ED patients who screened positive for past hazardous alcohol use to one of 3 groups : SMS assessments + feedback ( SA+F ) intervention who were asked to respond to drinking-related queries and received real-time feedback through SMS each Thursday and Sunday for 12 weeks ( n = 384 ) , SMS assessments ( SA ) who were asked to respond to alcohol consumption queries each Sunday but did not receive any feedback ( N = 196 ) , and a control group who did not participate in any SMS ( n = 185 ) .
METHODS	Primary outcomes were self-reported number of binge drinking days and number of drinks per drinking day in the past 30 days , collected by Web-based timeline follow-back method and analyzed with regression models .
METHODS	Secondary outcomes were the proportion of participants with weekend binge episodes and most drinks consumed per drinking occasion during 12 weekends , collected by SMS .
RESULTS	With Web-based data , there were decreases in the number of self-reported binge drinking days from baseline to 3 months in the SA+F group ( -0.51 [ 95 % confidence interval { CI } -0.10 to -0.95 ] ) , whereas there were increases in the SA group ( 0.90 [ 95 % CI 0.23 to 1.6 ] ) and the control group ( 0.41 [ 95 % CI -0.20 to 1.0 ] ) .
RESULTS	There were also decreases in the number of self-reported drinks per drinking day from baseline to 3 months in the SA+F group ( -0.31 [ 95 % CI -0.07 to -0.55 ] ) , whereas there were increases in the SA group ( 0.10 [ 95 % CI -0.27 to 0.47 ] ) and the control group ( 0.39 [ 95 % CI 0.06 to 0.72 ] ) .
RESULTS	With SMS data , there was a lower mean proportion of SA+F participants reporting a weekend binge during 12 weeks ( 30.5 % [ 95 % CI 25 % to 36 % ) compared with the SA participants ( 47.7 % [ 95 % CI 40 % to 56 % ] ) .
RESULTS	There was also a lower mean drinks consumed per weekend during 12 weeks in the SA+F group ( 3.2 [ 95 % CI 2.6 to 3.7 ] ) compared to the SA group ( 4.8 [ 95 % CI 4.0 to 5.6 ] ) .
CONCLUSIONS	A text message intervention can produce small reductions in self-reported binge drinking and the number of drinks consumed per drinking day in hazardous-drinking young adults after ED discharge .

###25304922
OBJECTIVE	To investigate the efficacy of a proactive feeding regimen ( PFR ) in reducing hospital length of stay in a population of moderately preterm small for gestational age ( SGA ) infants .
METHODS	SGA infants ( z-score < -1.28 ) of gestational age ( GA ) 32-36 weeks and birth weight ( BW ) > 1499 g were allocated at random to receive either a PFR , starting with 100 mL/kg/day and gradually increasing to 200 mL/kg/day by day 4 , or a standard feeding regimen , starting with 60 mL/kg/day and gradually increasing to 170 mL/kg/day by day 9 .
METHODS	All infants received human milk .
RESULTS	A total of 72 infants were randomized to the 2 groups , 36 to the PFR group ( mean GA , 35.1 0.7 weeks ; mean BW , 1761 177 g ) and 36 to the standard feeding regimen group ( mean GA , 35.5 1.2 weeks ; mean BW , 1754 212 g ) .
RESULTS	Infants in the PFR group were discharged significantly earlier ( mean , 9.8 3.1 days vs 11.9 4.7 days ; P = .029 ) .
RESULTS	The need for intravenous fluids ( 2.8 % vs 33.3 % ; P = .0013 ) and the incidence of hypoglycemia ( 0 vs 33.3 % ; P = .00016 ) were significantly lower in the PFR group .
RESULTS	Feeding intolerance and fecal calprotectin levels did not differ between the 2 groups .
CONCLUSIONS	A PFR in moderately preterm SGA infants is well tolerated and significantly reduces both the length of stay and the risk of neonatal hypoglycemia .

###25180608
OBJECTIVE	The study aimed to confirm the efficacy , through non-inferiority , of patient-driven versus investigator-driven titration of biphasic insulin aspart 30 ( BIAsp 30 ) in terms of glycemic control assessed by HbA1c change .
METHODS	SimpleMix was a 20 week , open-label , randomized , two-armed , parallel-group , multicenter study in five countries ( Argentina , China , India , Poland , and the UK ) .
METHODS	Patients with type 2 diabetes were randomized into either patient-driven or investigator-driven BIAsp 30 titration groups .
RESULTS	Non-inferiority of patient-driven vs. investigator-driven titration based on change in HbA1c from baseline to week 20 could not be demonstrated .
RESULTS	Mean ( SE ) estimated change from baseline to week 20 was -0.72 ( 0.08 ) % in the patient-driven group and -0.97 ( 0.08 ) % in the investigator-driven group ; estimated difference 0.25 % ( 95 % CI : 0.04 ; 0.46 ) .
RESULTS	Estimated mean change ( SE ) in fasting plasma glucose from baseline to week 20 was similar between groups : -0.94 ( 0.21 ) mmol/L for patient-driven and -1.07 ( 0.22 ) mmol/L for investigator-driven ( difference non-significant ) .
RESULTS	Both treatment arms were well tolerated , and hypoglycemic episode rates were similar between groups , with a rate ratio of 0.77 ( 95 % CI : 0.54 ; 1.09 ; p = 0.143 ) for all hypoglycemic episodes and 0.78 ( 95 % CI : 0.42 ; 1.43 ; p = 0.417 ) for nocturnal hypoglycemic episodes .
CONCLUSIONS	Non-inferiority of patient-driven versus investigator-driven titration with regard to change from baseline to end-of-treatment HbA1c could not be confirmed .
CONCLUSIONS	It is possible that a clinic visit 12 weeks after intensification of treatment with BIAsp 30 in patients with type 2 diabetes inadequately treated with basal insulin may benefit patient-driven titration of BIAsp 30 .
CONCLUSIONS	A limitation of the study was the relatively small number of patients recruited in each country , which does not allow country-specific analyses to be performed .
CONCLUSIONS	Overall , treatment with BIAsp 30 was well tolerated in both treatment groups .

###25109244
BACKGROUND	Daylight-mediated photodynamic therapy ( DL-PDT ) using methyl-5-aminolaevulinate ( MAL ) is effective for thin , grade I , actinic keratoses ( AK ) .
BACKGROUND	There are no published studies of other photosensitizers used in DL-PDT .
OBJECTIVE	To compare the efficacy and adverse effects of 5-aminolaevulinic acid nanoemulsion ( BF-200 ALA ) with MAL in DL-PDT of grade I-III AKs .
METHODS	In 13 patients , 177 AKs were randomized symmetrically for a split-face prospective observer-blinded study and received either BF-200 ALA or MAL DL-PDT .
METHODS	Grade I AKs were treated once and grade II-III AKs twice with a 025-mm layer of photosensitizer precursors .
METHODS	Pain was assessed during and after the daylight exposure .
METHODS	Efficacy at 3months was assessed clinically and histologically .
RESULTS	BF-200 ALA cleared 71/84 ( 845 % ) and MAL 69/93 ( 742 % ) of the AKs ( P = 0099 ) , all grades responding equally , but with new AKs appearing during follow-up ( n = 4 , BF-200 ALA ; n = 8 , MAL ) .
RESULTS	In per patient half-face analysis BF-200 ALA showed significantly higher clearance rates for grade I AKs than did MAL ( P = 0027 ) , but for thicker grades , clearance was equal ( P = 0564 ) .
RESULTS	BF-200 ALA and MAL treatments resulted in 615 % and 385 % complete histological clearance ( P = 0375 ) , respectively .
RESULTS	p53 expression decreased by 544 % and 337 % , respectively ( P = 0552 ) .
RESULTS	Both treatments were nearly painless with similar adverse reactions and no difference in patient preference .
CONCLUSIONS	BF-200 ALA showed a trend towards improved efficacy results compared with MAL .
CONCLUSIONS	Thicker lesions in both groups responded when treated repeatedly .
CONCLUSIONS	Importantly , a thin 025-mm layer of the photosensitizer precursors was sufficient , which may lead to lower expense .

###26216331
BACKGROUND	DTaP5-IPV-Hib-HepB is a fully liquid investigational hexavalent vaccine directed against 6 diseases .
METHODS	This multicenter , open-label , comparator-controlled , phase III study randomly assigned healthy infants 2-to-1 as follows : group 1 received DTaP5-IPV-Hib-HepB , PCV13 , and RV5 at 2 , 4 , and 6 months of age followed by DTaP5 , Hib-OMP , and PCV13 at 15 months of age ; group 2 received DTaP5-IPV/Hib , PCV13 , and RV5 at 2 , 4 , and 6 months of age , with HepB at 2 and 6 months of age , followed by DTaP5 , Hib-TT , and PCV13 at 15 months of age .
RESULTS	Overall , 981 participants were vaccinated in group 1 and 484 in group 2 .
RESULTS	Immune responses in group 1 to all antigens contained in DTaP5-IPV-Hib-HepB 1 month after dose 3 and for concomitant rotavirus vaccine were noninferior to those in group 2 , with the exception of antipertussis filamentous hemagglutinin ( FHA ) geometric mean concentrations ( GMCs ) .
RESULTS	Vaccine response rates for FHA were noninferior to control .
RESULTS	After the toddler dose , group 1 immune responses were noninferior to group 2 for all pertussis antigens .
RESULTS	Solicited adverse event rates after any dose were similar in both groups , with the exceptions of increased injection-site erythema , increased fever , and decreased appetite in group 1 .
RESULTS	Fever was not associated with hospitalization or seizures .
CONCLUSIONS	The safety and immunogenicity of DTaP5-IPV-Hib-HepB are comparable with the analogous licensed component vaccines .
CONCLUSIONS	Decreased FHA GMCs and increased injection-site reactions and fever are unlikely to be clinically significant .
CONCLUSIONS	DTaP5-IPV-Hib-HepB provides a new combination vaccine option aligned with the recommended US infant immunization schedule .

###25348459
BACKGROUND	In rural South Africa , only two-thirds of HIV-positive pregnant women seeking antenatal care at community health centers took full advantage of ` prevention of mother-to-child transmission ' ( PMTCT ) services in 2010 .
BACKGROUND	Studies generally support male involvement to promote PMTCT , but the nature and impact of that involvement is unclear and untested .
BACKGROUND	Additionally , stigma , disclosure and intimate partner violence pose significant barriers to PMTCT uptake and retention in care , suggesting that male involvement may be ` necessary , but not sufficient ' to reduce infant HIV incidence .
BACKGROUND	This study expands on a successful United States President 's Emergency Plan for AIDS Relief ( PEPFAR ) - supported PMTCT couples intervention pilot study conducted in the Mpumalanga province , targeting HIV-positive pregnant women and their partners , the primary objective being to determine whether male partner involvement plus a behavioral intervention will significantly reduce infant HIV incidence .
METHODS	The study follows a cluster randomized controlled design enrolling two cohorts of HIV-positive pregnant women recruited from 12 randomly assigned Community Health Centers ( CHC ) ( six experimental , six control ) .
METHODS	The two cohorts will consist of women attending without their male partners ( n = 720 ) and women attending with their male partners ( n = 720 couples ) , in order to determine whether the influence of male participation itself , or combined with a behavioral PMTCT intervention , can significantly reduce infant HIV infection ante - , peri - and postnatally .
CONCLUSIONS	It is our intention to significantly increase PMTCT participation from current levels ( 69 % ) in the Mpumalanga province to between 90 and 95 % through engaging women and couples in a controlled , six session ante - and postnatal risk-reducing and PMTCT promotion intervention addressing barriers to PMTCT ( such as stigma , disclosure , intimate partner violence , communication , infant feeding practices and safer conception ) that prevent women and men from utilizing treatment opportunities available to them and their infants .
CONCLUSIONS	Based upon the encouraging preliminary results from our pilot study , successful CHC adoption of the program could have major public health policy implications for containing the epidemic among the most vulnerable populations in rural South Africa : HIV-positive pregnant women and their infants .
BACKGROUND	ClinicalTrials.gov NCT02085356 ( registration date : 10 March 2014 ) .

###24724439
BACKGROUND	The aim of this study was to evaluate the analgesic efficacy and safety of rectus sheath block combined with intraperitoneal instillation using two doses of ropivacaine in patients undergoing laparoscopic gynecological surgery .
METHODS	Altogether 53 consenting women were randomized to receive intraperitoneal infiltration with 0.25 % ropivacaine or 0.5 % ropivacaine followed by rectus sheath block with 0.375 % ropivacaine .
METHODS	The outcomes of clinical safety were measured using plasma concentration of local anesthetics and occurrence of toxic symptoms .
METHODS	The analgesic efficacy was assessed using numerical rating scales for pain and morphine consumption up to 24 hours after surgery .
RESULTS	Patients ' baseline characteristics , surgical factors , and analgesic outcomes were comparable between the two groups .
RESULTS	Although peak plasma concentration of ropivacaine was significantly higher in patients receiving 0.5 % ropivacaine , none of analyzed concentrations was above the toxic ones .
RESULTS	Besides , no patients showed any symptoms of local anesthetic toxicity .
CONCLUSIONS	The present study showed that the combination of rectus sheath block with intraperitoneal instillation of ropivacaine was safe and potent enough to relieve pain after laparoscopic surgery .

###24721114
BACKGROUND	Despite growing interest in the importance of , and challenges associated with the involvement of patient and population ( IPP ) in the process of developing and adapting clinical practice guidelines ( CPGs ) , there is a lack of knowledge about the best method to use .
BACKGROUND	This is especially problematic in the field of rehabilitation , where individuals with disabilities might face many barriers to their involvement in the guideline development and adaptation process .
BACKGROUND	The goal of this pilot trial is to document the acceptability , feasibility and effectiveness of two methods of involving patients with a disability ( traumatic brain injury ) in CPG development .
METHODS	A single-blind , randomized , crossover pragmatic trial will be performed with 20 patients with traumatic brain injury ( TBI ) .
METHODS	They will be randomized into two groups , and each will try two alternative methods of producing recommendations ; a discussion group ( control intervention ) and a Wiki , a webpage that can be modified by those who have access to it ( experimental intervention ) .
METHODS	The participants will rate the acceptability of the two methods , and feasibility will be assessed using indicators such as the number of participants who accessed and completed the two methods , and the number of support interventions required .
METHODS	Twenty experts , blinded to the method of producing the recommendations , will independently rate the recommendations produced by the participants for clarity , accuracy , appropriateness and usefulness .
CONCLUSIONS	Our trial will allow for the use of optimal IPP methods in a larger project of adapting guidelines for the rehabilitation of individuals with TBI .
CONCLUSIONS	Ultimately the results will inform the science of CPG development and contribute to the growing knowledge about IPP in rehabilitation settings .
BACKGROUND	Clinical trial KT Canada 87776 .

###24393610
BACKGROUND	Evidence is often missing on social differentials in effects of nutrition interventions .
BACKGROUND	We evaluated the adherence to and effect of prenatal food and micronutrient supplementations on mortality before the age of five years in different social groups as defined by maternal schooling .
METHODS	Data came from the MINIMat study ( Maternal and Infant Nutrition Interventions , Matlab ) , a randomized trial of prenatal food supplementation ( invitation early , about 9 weeks [ E ] , or at usual time , about 20 weeks [ U ] of pregnancy ) and 30mg or 60mg iron with 400 gm folic acid , or multiple micronutrients ( Fe30F , Fe60F , MMS ) resulting in six randomization groups , EFe30F , UFe30F , EFe60F , UFe60F , EMMS , and UMMS ( n = 4436 ) .
METHODS	Included in analysis after omissions ( fetal loss and out-migration ) were 3625 women and 3659 live births of which 3591 had information on maternal schooling .
METHODS	The study site was rural Matlab , Bangladesh .
METHODS	The main stratifying variable was maternal schooling dichotomized as < 6years and 6years .
METHODS	We used Cox proportional hazard model for survival analyses .
RESULTS	Overall , women having < 6 years of schooling adhered more to food ( 81 vs. 69 packets , P = 0.0001 ) but a little less to micronutrient ( 104 vs. 120 capsules , P = 0.0001 ) supplementation compared to women having more schooling , adjusted for maternal age ( years ) , parity and body mass index ( BMI , kg/m2 ) at week 8 pregnancy .
RESULTS	Children of mothers with 6years of schooling had lower under-five mortality , but the EMMS supplementation reduced the social difference in mortality risk ( using standard program and schooling < 6years as reference ; standard program and schooling 6years HR 0.54 , 95 % CI 0.27-1 .11 ; EMMS and schooling 6years HR 0.28 , 95 % CI 0.12-0 .70 ; EMMS and schooling < 6years HR 0.26 , 95 % CI 0.11-0 .63 ) , adjusted for maternal age ( years ) , parity and body mass index ( kg/m2 ) at week 8 pregnancy .
CONCLUSIONS	The combination of an early invitation to prenatal food supplementation and multiple micronutrient supplementation lowered mortality in children before the age of five years and reduced the gap in child survival chances between social groups .
CONCLUSIONS	The pattern of adherence to the supplementations was complex ; women with less education adhered more to food supplementation while those with more education had higher adherence to micronutrients .
BACKGROUND	ISRCTN16581394 .

###25074767
OBJECTIVE	To create a risk model for neovascular age-related macular degeneration ( nAMD ) based on nongenetic factors .
METHODS	In this case-control study , 1459 individuals were included , 445 patients showed nAMD and 1014 were healthy controls .
METHODS	Participants were randomly assigned into a training set ( containing two-thirds of individuals ) and a validation set .
METHODS	Stepwise logistic regression analysis was performed for 25 environmental risk factors in the training set .
METHODS	The risk model with the remaining factors was then validated in the validation set using receiver operating characteristics ( ROC ) curve and Hosmer-Lemeshow-Test .
METHODS	Additionally , a genetic risk model including variants in the complement factor H gene ( CFH , rs1061170 ) and the age-related maculopathy susceptibility 2 gene ( ARMS2 , rs10490924 ) was generated .
RESULTS	The environmental risk model with the factors age , alcohol use , allergy , education , sunlight exposure , fish consumption , and physical exercise showed an AUC of 0.80 ( 95 % confidence interval [ CI ] 0.76-0 .84 ) in the training set .
RESULTS	Validation of the model showed adequate calibration ( Hosmer-Lemeshow P = 0.81 ) .
RESULTS	The AUC for the genetic model was 0.77 ( 95 % CI 0.730-0 .808 ) , for the combined environmental and genetic model 0.92 ( 95 % CI 0.887-0 .947 ) .
CONCLUSIONS	Seven nongenetic factors are able to provide equivalent discrimination between nAMD patients and controls to genetic risk models .
CONCLUSIONS	Most of them are modifiable and give the opportunity for counseling patients .

###24509938
BACKGROUND	The surgical wound of total knee arthroplasty ( TKA ) needs continuous flexion and extension movement .
BACKGROUND	Silicone gel treatment is widely used to treat hypertrophic scars and keloids since it is easily applied and prevents scar pain and itching .
BACKGROUND	The aim of this study was to evaluate the clinical efficacy and safety of silicone gel applied to surgical scars of TKA on postoperative scar pain and pruritus .
METHODS	One hundred TKAs were randomized into a silicone gel group ( silicone gel was applied to the wound after stitch-out for 1 month ) or a placebo group .
METHODS	The postoperative scar pain and pruritus were evaluated with the use of a visual analog scale ( VAS ) at postoperative 3 months , 6 months and 1 year .
METHODS	Scar assessment was done using the Vancouver scar scale by evaluating scar pigmentation , vascularity , pliability , and height .
RESULTS	Although silicone gel group showed better pigmentation and height scales than placebo group ( P < 0.05 ) , there were no significant differences in the postoperative scar pain and pruritus VAS scores between the groups ( P > 0.05 ) .
CONCLUSIONS	Application of silicone gel had no beneficial effects on scar pain and itching relief during the early postoperative period of TKA .
METHODS	I-Randomized Controlled Trial .

###24443830
OBJECTIVE	Two treatment strategies were compared in patients with type 2 diabetes ( T2DM ) on basal insulin requiring intensification : addition of once-daily ( OD ) liraglutide ( Lira ) or OD insulin aspart ( IAsp ) with largest meal .
METHODS	Subjects completing 104weeks ( 52-week main trial BEGIN ONCE-LONG + 52-week extension ) on insulin degludec ( IDeg ) OD + metformin with HbA1c7 .0 % ( 53mmol/mol ) were randomized to IDeg + Lira [ n = 88 , mean HbA1c : 7.7 % ( 61mmol/mol ) ] or IDeg + IAsp ( n = 89 , mean HbA1c : 7.7 % ) for 26weeks , continuing metformin .
METHODS	Subjects completing 104weeks with HbA1c < 7.0 % continued IDeg + metformin in a third , non-randomized arm ( n = 236 ) .
RESULTS	IDeg + Lira reduced HbA1c ( -0.74 % - points ) significantly more than IDeg + IAsp ( -0.39 % - points ) ; estimated treatment difference ( ETD ) ( IDeg + Lira-IDeg + IAsp ) -0.32 % - points ( 95 % CI -0.53 ; -0.12 ) ; p = 0.0024 .
RESULTS	More IDeg + Lira ( 49.4 % ) than IDeg + IAsp ( 7.2 % ) subjects achieved HbA1c < 7.0 % without confirmed hypoglycaemia [ plasma glucose < 3.1 mmol/l ( < 56mg/dl ) or severe hypoglycaemia ) and without weight gain ; estimated odds ratio ( IDeg + Lira/IDeg + IAsp ) 13.79 ( 95 % CI 5.24 ; 36.28 ) ; p < 0.0001 .
RESULTS	IDeg + Lira subjects had significantly less confirmed and nocturnal confirmed hypoglycaemia , and significantly greater weight loss ( -2.8 kg ) versus IDeg + IAsp ( +0.9 kg ) ; ETD ( IDeg + Lira-IDeg + IAsp ) -3.75 kg ( 95 % CI -4.70 ; -2.79 ) ; p < 0.0001 .
RESULTS	Other than more gastrointestinal side effects with IDeg + Lira , no safety differences occurred .
RESULTS	Durability of IDeg was established in the non-randomized arm , as mean HbA1c remained < 7.0 % [ mean 6.5 % ( 48mmol/mol ) at end-of-trial ] .
CONCLUSIONS	IDeg + Lira improved long-term glycaemic control , with weight loss and less hypoglycaemia versus adding a single daily dose of IAsp in patients with T2DM inadequately controlled with IDeg + metformin .

###24939489
OBJECTIVE	The effects of i.v. remifentanil in combination with an inhaled anesthetic to facilitate tracheal extubation of deeply anesthetized adults after otologic surgery are investigated .
METHODS	Fifty patients undergoing middleear surgery were recruited for the study .
METHODS	All patients were administered deep anesthesia ( i.v. fentanil , propofol , and mivacurium ) and intubated , with subsequent administration of inhaled sevoflurane for anesthesia maintenance .
METHODS	Prior to endotracheal tube removal , the patients received i.v. dexamethasone , ondansetron hydrochloride , and parecoxib and were randomly allocated to two groups .
METHODS	In group S ( n = 25 ) , anesthesia was maintained with sevoflurane alone ( 1.3 times the minimum effective alveolar concentration [ MAC ] ) , while patients in group SR ( n = 25 ) received low-dose i.v. remifentanil and a reduced dose of sevoflurane ( 1.0 MAC ) .
RESULTS	The mean remifentanil dosage was 0.028 g/kg per minute .
RESULTS	Relative to patients in group S , patients in group SR had a significantly lower mean respiratory rate ( 6.4 breaths per minute versus 15.8 breaths per minute , p < 0.01 ) and end-tidal carbon dioxide pressure ( 48.1 mm Hg versus 52.1 mm Hg , p < 0.05 ) after extubation .
RESULTS	Postextubation airway obstructions requiring nasal airway placement were less frequent in group SR ( 14 cases versus 2 cases in group S , p < 0.05 ) ; patients in group SR also had a shorter mean time to awakening ( 19.5 minutes versus 15.8 minutes , p < 0.05 ) and a shorter mean time to orientation ( 31.4 minutes versus 26.1 minutes , p < 0.05 ) .
CONCLUSIONS	Sevoflurane combined with remifentanil provided rapid recovery and appeared to be safe for deep-anesthesia tracheal extubation in adult patients after otologic surgery .

###24639419
OBJECTIVE	Evaluate the effect of high-oleic and conventional peanuts within a hypocaloric-diet on energy metabolism and body composition .
METHODS	This 4-week randomized clinical trial included males with BMI of 29.72.4 kg m ( -2 ) and aged between 18 and 50 years .
METHODS	Participants were assigned to the groups : control ( CT , n = 22 ) that followed a hypocaloric-diet ; conventional peanuts ( CVP , n = 22 ) or high-oleic peanuts ( HOP , n = 21 ) that received the hypocaloric-diet including ( not adding ) 56 g day ( -1 ) of peanuts .
METHODS	Glucose , fat oxidation , and body fatness and lean mass were the main outcomes .
RESULTS	Body weight and composition did not differ between groups .
RESULTS	However , within group total body fat ( kg ) reduced with CVP and HOP , with a significant decrease in body fat percentage in HOP .
RESULTS	While total lean mass ( kg ) decreased in CT , total lean mass ( % ) increased in HOP .
RESULTS	Truncal lean mass decreased in the CT. .
RESULTS	At baseline , HOP had greater postprandial fat oxidation than the CVP .
RESULTS	After 4-weeks , fasting fat oxidation increased in CVP and HOP .
RESULTS	Fat oxidation increased in CT and HOP during the 200 min after meal intake compared to the fasting condition .
CONCLUSIONS	Regular peanut consumption , especially the high-oleic type , within a hypocaloric-diet increased fat oxidation and reduced body fatness in overweigh and obese men .

###24938176
OBJECTIVE	To determine the effects of the herbal fixed-dose combination PRO 160/120 ( extracts from saw palmetto fruits and stinging nettle roots ) on nocturnal voiding frequency , as measured by question 7 of the IPSS questionnaire , in patients with moderate-to-severe LUTS/BPH after 24 weeks of treatment compared to placebo , to the - blocker tamsulosin , or to the 5-reductase inhibitor finasteride .
METHODS	The study is about post hoc evaluation of four published randomized , double-blind clinical trials on PRO 160/120 , two compared with placebo , one with finasteride and one with tamsulosin .
METHODS	In addition , a pooled data analysis of the two placebo-controlled trials was conducted .
RESULTS	We analyzed data from a total of 922 patients with a mean age of 66 years and a mean baseline nocturnal voiding frequency of 2.1 .
RESULTS	In the pooled analysis of placebo-controlled trials , nocturnal voids improved by 0.8 ( 29 % ) with PRO 160/120 compared to 0.6 ( 18 % ) with placebo ( p = 0.015 , Wilcoxon test , one-tailed ) .
RESULTS	The 69 % responder rate to PRO 160/120 was significantly superior to the placebo response ( 52 % ; p = 0.003 , ( 2 ) - test , two-tailed ) .
RESULTS	The majority of responders improved by 1 void/night .
RESULTS	Absolute improvements and response rates were consistently higher with PRO 160/120 than with placebo over a range of baseline nocturnal voiding frequencies .
RESULTS	There were no differences between PRO 160/120 and finasteride or tamsulosin regarding absolute improvement of nocturnal voids or responds rates .
CONCLUSIONS	PRO 160/120 significantly improved nocturnal voiding frequency compared to placebo and similar to tamsulosin or finasteride .

###25872929
BACKGROUND	That patients with acute radiculopathy caused by lumbar disc herniation ( LDH ) will benefit from spinal manipulation ( SM ) treatment has been taken for granted , despite no solid evidence to support that claim .
BACKGROUND	There is a demand for a win-win SM treatment that is both effective and less risky , and we attempt to use this trial to demonstrate such a treatment .
BACKGROUND	In this study , Feng 's Spinal Manipulative Therapy ( FSM ) is selected as the observational SM .
BACKGROUND	FSM can be performed with either manipulation or mobilization , and also can be easily mimicked as a sham SM .
METHODS	Two hundred and sixteen qualified hospitalized participants will be randomly allocated to one of the three following groups : sham SM , mobilization , or manipulation , according to a ratio of 1:1:1 .
METHODS	Participants in each group will receive specific FSM treatments four times , along with basic therapies over a course of 2 weeks .
METHODS	Two days after each SM appointment , risk outcomes will be assessed using a questionnaire developed to identify accompanying unpleasant reactions ( AUR ) .
METHODS	The pain pressure threshold ( PPT ) will be measured paraspinally on the tender spot beside the involved joint before and immediately after each SM treatment .
METHODS	Relative risk ( RR ) of AUR , number needed to harm ( NNH ) and the 95 % confidence intervals of each group will be calculated and compared .
METHODS	Benefit outcomes will be assessed by analyzing the following data recordings : the Numerical Rating Scale ( NRS ) , Oswestry Disability Index ( ODI ) , and Global Perceived Effect ( GPE ) before enrollment and at the 7th , and 15th day after the treatment .
METHODS	Analyses will include comparisons of NRS , ODI and changes at the different visit times among the three groups by Repeated Measures Data ANOVA , an evaluation of reduced scores of NRS and ODI after the therapy to determine if they meet the minimum acceptable outcome ( MAO ) , and the determination of the minimal clinically important difference ( MCID ) by the average improvement in NRS and ODI scores of all participants who have been allocated to the category ` improved ' on the GPE assessment .
BACKGROUND	This trial is registered in Chinese Clinical Trial Register ( ChiCTR ) on 19 August 2013 ( ChiCTR-TRC-13003496 ) .

###26255515
OBJECTIVE	To compare the differences in the efficacy on depression after breast cancer operation treated with auricular point sticking therapy , the combined program of auricular point sticking therapy and TCM psychotherapy and medication with deanxit .
METHODS	Ninety patients were randomized into 3 groups , 30 cases in each one .
METHODS	In the western medication group , the simple oral administration of deanxit was applied , one tablet a day .
METHODS	In the auricular point group , Xin ( GO15 ) , Shen ( CO10 ) , Gan ( CO12 ) , Shenmen ( TF4 ) , Pizhixia ( AT ) , Neifenmi ( CO18 ) were selected and stimulated with auricular point sticking on either side in each treatment , once a week .
METHODS	In the combined program group , on the basis of the treatment as the auricular point group , TCM psychotherapy was combined with .
METHODS	The treatment of 4 weeks made one session .
METHODS	One session and 4 weeks follow-up were required .
METHODS	The self-rating depression scale ( SDS ) was used to compare the score before and after treatment in the patients of each group and the efficacy was assessed .
RESULTS	( 1 ) Compared with those before treatment , in 4 weeks of treatment and 4 weeks of follow-up , SDS scores were all reduced apparently in the 3 groups ( all P < 0.001 ) .
RESULTS	After 4 weeks of follow-up in the auricular point group , after 2 and 4 weeks of treatment and 4 weeks of follow-up in the combined program group , SDS scores were all lower than those in the western medication group ( all P < 0.05 ) .
RESULTS	( 2 ) After 4 weeks of treatment , the curative rate in the combined program group was higher than that in the auricular point group and the western medication group [ 60.0 % ( 18/30 ) vs. 40.0 % ( 12/30 ) , 36.7 % ( 11/30 ) , both P < 0.05 ) ] .
RESULTS	After 4 weeks of follow-up , the curative rate in either the combined program group or the auricular point group was higher than that in the western medication group [ 60.0 % ( 18/30 ) , 30.0 % ( 19/30 ) vs. 23.3 % ( 7/30 ) , both P < 0.05 ] .
CONCLUSIONS	The auricular point sticking therapy , the combined program of auricular point sticking therapy and TCM psychotherapy , and medication with deanxit all relieve depression after breast cancer operation .
CONCLUSIONS	The efficacy of the combined program with auricular point sticking therapy and TCM psychotherapy involved is the best , and the efficacy of the auricular point sticking therapy is better than the oral administration of deanxit .

###25920297
BACKGROUND	Postoperative nausea and vomiting ( PONV ) are significant problems in laparoscopic surgery .
OBJECTIVE	Compare the prophylactic use of metoclopramide and its combination with dexamethasone in the prevention of PONV in patients undergoing laparoscopic cholecystectomy ( LC ) .
METHODS	One hundred patients aged 18 to 75 with American Society of Anesthesiologists ( ASA ) class 1-2 who candidates for elective LC at Chiang Mai University Hospital , were included in this double-blind , randomized controlled trial ( parallel design ) .
METHODS	Patients were randomly divided into two groups , by ` Block offour ` randomization .
METHODS	Treatment group received 8 mg dexamethasone and 10 mg metoclopramide , and control group received 10 mg metoclopramide and normal saline solution 1.6 ml .
METHODS	These medications were administered intravenously when the gallbladder was removedfrom gallbladder bed .
METHODS	All of investigators , anesthetists , patients , care providers , and outcome assessor were blinded .
METHODS	Patients were asked to assess their nausea and vomiting at 2 , 6 , 12 , and 24 hours postoperatively , and at discharge .
METHODS	The overall score of PONV in each patient based on afour-point whole number of nausea and vomiting by verbal rating scale 0-3 ( 0 = no nausea and vomiting , 1 = nausea , 2 = nausea with vomiting , and 3 = repeated vomiting > 2 times ) .
RESULTS	Fifty eligible patients were randomized to each group , and all were analyzed .
RESULTS	There were no significant differences between baseline characteristics of patients in the two groups .
RESULTS	The combination of dexamethasone and metoclopramide indicated a greater antiemetic effect with significant statistical analysis , odds ratio = 0.25 ( 95 % confidence interval O. 11-0 .55 , p = 0.001 ) .
RESULTS	Thepostoperative hospital stay in the combined group and metoclopramide group were , 1 day = 47 ( 94 % ) and 37 ( 74 % ) , > 1 day = 3 ( 6 % ) and 13 ( 26 % ) , respectively ( p = 0.012 ) .
RESULTS	There were no postoperative complications occurred in both groups .
CONCLUSIONS	Intravenous administration of dexamethasone combined with metoclopramide had significant effects in prophylaxis of nausea and vomiting after LC and shorten the hospital stay .
CONCLUSIONS	Clinical trials registration number : TCTR20140128001

###25036533
BACKGROUND	The prevalence of type 2 diabetes ( T2D ) in youth is increasing .
BACKGROUND	Treatment options beyond metformin and insulin are needed .
BACKGROUND	The safety , tolerability , pharmacokinetics , and pharmacodynamics of liraglutide once daily in youth ( 10-17 years old ) with T2D were investigated in a randomized , double-blind , placebo-controlled trial .
METHODS	Youth treated with diet/exercise alone or with metformin and having a hemoglobin A1c ( HbA1c ) level of 6.5-11 % were randomized to liraglutide ( n = 14 ) or placebo ( n = 7 ) .
METHODS	Starting at 0.3 mg/day , doses were escalated weekly to 0.6 , 0.9 , 1.2 , and 1.8 mg/day ( or placebo equivalent ) for 5 weeks .
RESULTS	Nineteen participants completed the trial .
RESULTS	Baseline characteristics were similar between groups , with mean ( SD ) values for age of 14.8 ( 2.2 ) years , weight of 113.2 ( 35.6 ) kg ( range , 57-214 kg ) , diabetes duration of 1.7 ( 1.4 ) years , and HbA1c level of 8.1 % ( 1.2 % ) .
RESULTS	No serious adverse events ( AEs ) , including severe hypoglycemia , occurred .
RESULTS	Transient gastrointestinal AEs were most common at lower liraglutide doses during dose escalation .
RESULTS	No significant changes in safety and tolerability parameters occurred .
RESULTS	There was no evidence of pancreatitis or lipase elevations above three times the upper normal limit ; calcitonin levels remained within the normal range .
RESULTS	For liraglutide 1.8 mg , mean half-life was 12 h , and clearance was 1.7 L/h .
RESULTS	After 5 weeks , the decline in HbA1c level was greater with liraglutide versus placebo ( -0.86 vs. 0.04 % , P = 0.0007 ) , whereas mean body weight remained stable ( -0.50 vs. -0.54 kg , P = 0.9703 ) .
CONCLUSIONS	Liraglutide was well tolerated in youth with T2D , with safety , tolerability , and pharmacokinetic profiles similar to profiles in adults .

###24618326
OBJECTIVE	We investigated single nucleotide polymorphisms ( SNPs ) of thrombospondin-1 ( TSP-1 ) on the risk of corneal allograft rejection .
OBJECTIVE	The TSP-1 is known to be involved in the immune response of the anterior chamber of the eye , activating TGF-2 , promoting peripheral and systemic tolerance , and counteracting the proangiogenic activity of VEGF .
METHODS	Three tagging SNPs spanning the TSP-1 region ( rs1478604 , A > G ; rs2228261 , C > T ; and rs2228262 , A > G ) were genotyped .
METHODS	Association with risk of rejection was investigated in a group of 378 corneal transplant recipients with risk factors for allograft rejection .
METHODS	Transplant recipients had completed 3-year follow-up .
RESULTS	The TSP-1 rs1478604 A SNP was associated significantly with an increased risk of corneal allograft rejection ( odds ratio [ OR ] , 1.58 ; 95 % confidence interval [ CI ] , 1.02-2 .45 ; P = 0.04 ) and there was a trend toward the rs1478604 , rs2228261 , rs2228262 ACA haplotype increasing risk of rejection .
CONCLUSIONS	The results suggest that TSP-1 rs1478604 AA homozygotes may be at increased risk of corneal transplant rejection , especially if they carry the ACA haplotype .

###24255061
BACKGROUND	Evolocumab ( AMG 145 ) , a monoclonal antibody against proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) , significantly reduced low-density lipoprotein cholesterol ( LDL-C ) in phase 2 studies of 12 weeks ' duration .
BACKGROUND	The longer-term efficacy and safety of PCSK9 inhibition remain undefined .
RESULTS	Of 1359 randomized and dosed patients in the 4 evolocumab phase 2 parent studies , 1104 ( 81 % ) elected to enroll into the Open-Label Study of Long-term Evaluation Against LDL-C ( OSLER ) study .
RESULTS	Regardless of their treatment assignment in the parent study , patients were randomized 2:1 to receive either open-label subcutaneous evolocumab 420 mg every 4 weeks with standard of care ( SOC ) ( evolocumab + SOC , n = 736 ) or SOC alone ( n = 368 ) .
RESULTS	Ninety-two percent of patients in the evolocumab + SOC group and 89 % of patients in the SOC group completed 52 weeks of follow-up .
RESULTS	Patients who first received evolocumab in OSLER experienced a mean 52.3 % [ SE , 1.8 % ] reduction in LDL-C at week 52 ( P < 0.0001 ) .
RESULTS	Patients who received 1 of 6 dosing regimens of evolocumab in the parent studies and received evolocumab + SOC in OSLER had persistent LDL-C reductions ( mean reduction , 50.4 % [ SE , 0.8 % ] at the end of the parent study versus 52.1 % [ SE , 1.0 % ] at 52 weeks ; P = 0.31 ) .
RESULTS	In patients who discontinued evolocumab on entry into OSLER , LDL-C levels returned to near baseline levels .
RESULTS	Adverse events and serious adverse events occurred in 81.4 % and 7.1 % of the evolocumab + SOC group patients and 73.1 % and 6.3 % of the SOC group patients , respectively .
CONCLUSIONS	Evolocumab dosed every 4 weeks demonstrated continued efficacy and encouraging safety and tolerability over 1 year of treatment in the largest and longest evaluation of a PCSK9 inhibitor in hypercholesterolemic patients to date .
BACKGROUND	http://clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01439880 .

###25448627
BACKGROUND	There is a need to identify innovative , low-cost and broad-reaching strategies for promoting exercise and improving physical function in older adults with multiple sclerosis ( MS ) .
METHODS	This randomised controlled pilot trial will test the efficacy of a 6-month , DVD-delivered exercise intervention to improve functional performance and quality of life in older adults with MS. Participants will be randomised either into a DVD-delivered exercise condition or an attentional control condition .
METHODS	This novel approach to programme delivery provides participants with detailed exercise instructions which are presented in a progressive manner and includes a variety of modifications to better meet varying levels of physical abilities .
METHODS	The targeted exercises focus on three critical elements of functional fitness : flexibility , strength and balance .
METHODS	It is hypothesised that participants who are randomised to the exercise DVD condition will demonstrate improvements in physical function compared with participants assigned to the attentional control condition .
METHODS	Data analysis will include a 2 ( condition ) 2 ( time ) mixed factor analysis of variance ( ANOVA ) that follows intent-to-treat principles , as well as an examination of effect sizes .
METHODS	Participants will take part in qualitative interviews about perspectives on physical activity and programme participation .
BACKGROUND	The study protocol was approved by a university institutional review board and registered with a federal database .
BACKGROUND	Participants will be asked to read and sign a detailed informed consent document and will be required to provide a physician 's approval to participate in the study .
BACKGROUND	The exercise DVDs include an overview of safety-related concerns and recommendations relative to exercise participation , as well as detailed instructions highlighting the proper execution of each exercise presented on screen .
BACKGROUND	Following completion of this trial , data will be immediately analysed and results will be presented at scientific meetings and published in scholarly journals .
BACKGROUND	Clinical Trials NCT01993095 .

###24947537
BACKGROUND	Poverty undermines the adherence of patients to tuberculosis treatment .
BACKGROUND	A pragmatic cluster randomized controlled trial was conducted to investigate the extent to which economic support in the form of a voucher would improve patients ' adherence to treatment , and their treatment outcomes .
BACKGROUND	Although the trial showed a modest improvement in the treatment success rates of the intervention group , this was not statistically significant , due in part to the low fidelity to the trial intervention .
BACKGROUND	A qualitative process evaluation , conducted in the final few months of the trial , explained some of the factors that contributed to this low fidelity .
METHODS	In-depth interviews were conducted with patients who received vouchers , nurses in intervention clinics , personnel in shops who administered the vouchers , and managers of the TB Control Programme .
METHODS	These interviews were analyzed thematically .
RESULTS	The low fidelity to the trial intervention can be explained by two main factors .
RESULTS	The first was nurses ' tendency to ` ration ' the vouchers , only giving them to the most needy of eligible patients and leaving out those eligible patients whom they felt were financially more comfortable .
RESULTS	The second was logistical issues related to the administration of the voucher as vouchers were not always available for patients on their appointed clinic dates , necessitating further visits to the clinics which they were not always able to make .
CONCLUSIONS	This process evaluation identifies some of the most important factors that contributed to the results of this pragmatic trial .
CONCLUSIONS	It highlights the value of process evaluations as tools to explain the results of randomized trials and emphasizes the importance of implementers as ` street level bureaucrats ' who may profoundly affect the way an intervention is administered .
BACKGROUND	Current Controlled Trials ISRCTN50689131 , registered 21 April 2009 .
BACKGROUND	The trial protocol is available at the following web address : http://www.hst.org.za/publications/study-protocol-economic-incentives-improving-clinical-outcomes-patients-tb-south-africa .

###24417235
BACKGROUND	India has 275 million adult tobacco users and tobacco use is estimated to contribute to more than a million deaths in the country each year .
BACKGROUND	There is an urgent need to develop and evaluate affordable , practicable and scalable interventions to promote cessation of tobacco use .
BACKGROUND	Because tobacco use is so harmful , an increase of as little as 1 percentage point in long-term quit success rates can have an important public health impact .
BACKGROUND	This protocol paper describes the rationale and methods of a large randomized controlled trial which aims to evaluate the effectiveness of a brief scalable smoking cessation intervention delivered by trained health professionals as an outreach programme in poor urban communities in India .
METHODS	This is a pragmatic , two-arm , community-based cluster randomized controlled trial focused on tobacco users in low-income communities .
METHODS	The treatment arm is a brief intervention comprising brief advice including training in craving control using simple yogic breathing exercises ( BA-YBA ) and the control arm is very brief advice ( VBA ) .
METHODS	Of a total of 32 clusters , 16 will be allocated to the intervention arm and 16 to the control arm .
METHODS	Each cluster will have 31 participants , making a total of 992 participants .
METHODS	The primary outcome measure will follow the Russell Standard : self-report of sustained abstinence for at least 6 months following the intervention confirmed at the final follow-up by salivary cotinine .
CONCLUSIONS	This trial will inform national and international policy on delivery of scalable and affordable brief outreach interventions to promote tobacco use cessation in low resource settings where tobacco users have limited access to physicians and medications .

###25080293
BACKGROUND	Short children born small for gestational age ( SGA ) are treated with a GH dose based on body size , but treatment may lead to high levels of IGF1 .
BACKGROUND	The objective was to evaluate IGF1 titration of GH dose in contrast to current dosing strategies .
METHODS	In the North European Small-for-Gestational-Age Study ( NESGAS ) , 92 short pre-pubertal children born SGA were randomised after 1 year of high-dose GH treatment ( 67g/kg per day ) to three different regimens : high dose ( 67g/kg per day ) , low dose ( 35g/kg per day ) or IGF1 titration .
RESULTS	The average dose during the second year of the randomised trial did not differ between the IGF1 titration group ( 38g/kg per day , s.d. 0.019 ) and the low-dose group ( 35g/kg per day , s.d. 0.002 ; P = 0.46 ) , but there was a wide variation in the IGF1 titration group ( range 10-80g / kg per day ) .
RESULTS	The IGF1 titration group had significantly lower height gain ( 0.17 SDS , s.d. 0.18 ) during the second year of the randomised trial compared with the high-dose group ( 0.46 SDS , s.d. 0.25 ) , but not significantly lower than the low-dose group ( 0.23 SDS , s.d. 0.15 ; P = 0.17 ) .
RESULTS	The IGF1 titration group had lower IGF1 levels after 2 years of the trial ( mean 1.16 , s.d. 1.24 ) compared with both the low-dose ( mean 1.76 , s.d. 1.48 ) and the high-dose ( mean 2.97 , s.d. 1.63 ) groups .
CONCLUSIONS	IGF1 titration of GH dose in SGA children proved less effective than current dosing strategies .
CONCLUSIONS	IGF1 titration resulted in physiological IGF1 levels with a wide range of GH dose and a poorer growth response , which indicates the role of IGF1 resistance and highlights the heterogeneity of short SGA children .

###24346280
OBJECTIVE	To quantify the effect of food on the systemic exposure of lapatinib at steady state when administered 1 h before and after meals , and to observe the safety and tolerability of lapatinib under these conditions in patients with advanced solid tumours .
METHODS	This was a three-treatment , randomised , three-sequence cross-over study .
METHODS	Lapatinib was administered 1 h after a low - [ B ] or a high-fat [ C ] meal and systemic exposure was compared with that obtained following administration 1 h before a low-fat meal [ A ] .
RESULTS	In total , 25 patients were included , of whom 12 were evaluable for the pharmacokinetic analysis .
RESULTS	Both low-fat and high-fat meals affected lapatinib exposure .
RESULTS	Lapatinib AUC0-24 increased following lapatinib administration 1 h after a low-fat meal by 1.80-fold ( 90 % CI : 1.37-2 .37 ) and after a high-fat meal by 2.61-fold ( 90 % CI : 1.98-3 .43 ) .
RESULTS	Lapatinib Cmax increased following lapatinib administration 1 h after a low-fat meal by 1.90-fold ( 90 % CI : 1.49-2 .43 ) and after a high-fat meal by 2.66-fold ( 90 % CI : 2.08-3 .41 ) .
RESULTS	The most commonly occurring treatment-related toxicity was diarrhoea ( 8/25 , 32 % CTCAE grade 1 and 2/25 , 8 % grade 2 ) and one treatment-related grade3 event occurred ( fatigue grade 3 , 4 % ) .
CONCLUSIONS	Both low-fat and high-fat food consumed 1 h before lapatinib administration increased lapatinib systemic exposure compared with lapatinib administration 1 h before a low-fat meal .
CONCLUSIONS	In order to administer lapatinib in a fasted state , it is advised to administer the drug 1 h before a meal .

###25435406
OBJECTIVE	Inserting a nasogastric tube ( NGT ) in intubated patients may be difficult because they can not follow swallowing instructions , resulting in a high rate of first-attempt failure .
OBJECTIVE	We introduce a simple technique for inserting an orogastric tube in an emergency department ( ED ) .
METHODS	Fifty-six patients in the ED , who were intubated and required NGT insertion , were randomly allocated to 2 groups .
METHODS	We inserted the NGT using a conventional technique from the nostril ( control group ) and an endotracheal tube ( ET ) - assisted technique from the mouth ( ET group ) .
METHODS	The procedures ' success rate , insertion duration , and complications were compared between the groups .
RESULTS	There was a significantly higher overall success rate in the ET group than the control group ( 100 % vs 64 % , P < .001 ) .
RESULTS	Endotracheal tube group showed 100 % first-attempt success rate , but 50 % of the control group failed at first attempt .
RESULTS	Mean duration of the first trial was not significantly different between the ET and control groups ( 58.016.9 vs 57.329.5 seconds , P = .903 ) , but total time for successful insertion was longer in the control group than the ET group ( 58.016.9 vs 111.774.5 seconds , P < .001 ) .
RESULTS	There was less NGT kinking and more mucosal bleeding in the ET group than in the control group ( 0 % vs 16 % , P = .019 ; 16 % vs 7 % , P = .225 , respectively ) .
CONCLUSIONS	Endotracheal tube-assisted orogastric tube insertion technique showed a higher rate of successful insertion and shorter total duration .
CONCLUSIONS	With this result , ET-assisted orogastric tube insertion would be useful in ED .

###25557985
OBJECTIVE	Intramuscular botulinum toxin-A ( BoNT-A ) injections reduce spasticity by blocking neurotransmission at the motor endplate ( MEP ) .
OBJECTIVE	The goal of this study was to assess the reduction in spasticity achieved by injecting BoNT-A at different sites of the gracilis muscle .
METHODS	Thirty-four gracilis muscles , in 27 children ( 10 females and 17 males , mean age of 8.6 y [ SD 2.5 y ] ) with spastic cerebral palsy ( unilateral and bilateral , Gross Motor Function Classification System [ GMFCS ] levels I-IV ) , were randomly assigned to one of two groups .
METHODS	In one group BoNT-A was injected proximally ( at a site 25 % of the distance from the pubic tubercle and the medial epicondyle ) and in the other it was injected at the MEP zones ( half of the dose was administered at 30 % of this distance and half at 60 % ) .
METHODS	Spasticity was assessed before and after BoNT-A injection using simultaneous measurements of surface electromyography ( sEMG ) and angular velocity during passive muscle stretch applied at different velocities .
METHODS	The primary outcome measure included the velocity-dependent change in average root mean square electromyography ( RMS-EMG ) .
METHODS	Secondary outcome was assessed with the Modified Ashworth Scale ( MAS ) and Modified Tardieu Scale ( MTS ) .
RESULTS	Spasticity decreased more in MEP-targeted muscles than in proximally injected muscles , as demonstrated by a larger reduction in average RMS-EMG values ( p = 0.04 ) , though this difference was not found with the MAS or MTS .
CONCLUSIONS	The results suggest that BoNT-A injection of the gracilis at sites with a high concentration of MEPs is effective at reducing spasticity .
CONCLUSIONS	These preliminary findings should be confirmed by larger studies .
CONCLUSIONS	In the case of long muscles , such as the gracilis , the injection site is important .

###25750345
BACKGROUND	More than 50 % of patients with advanced breast cancer develop bone metastases that may lead to multiple complications such as pathological fractures , bone pain or hypercalcaemia .
BACKGROUND	The standard treatment , besides endocrine , targeted-therapy or chemotherapy , is the use of bisphosphonates .
BACKGROUND	However , one of their main adverse side-effects is bisphosphonate-induced nephrotoxicity .
BACKGROUND	The mechanism by which the latter occurs is not well-understood , although emerging evidence suggests that the effect of bisphosphonates on the kidney may differ between agents .
METHODS	The aim of this evaluation was to compare the renal toxicity of 6 mg ibandronate i.v. versus 4 mg zoledronic acid i.v. over a period of six months in women with breast cancer and bone metastases .
METHODS	A prospective randomized trial was carried out to examine specific kidney and other parameters ( 1 - and 2-microglobulin , albumin , 2-macroglobulin , IgG and C-reactive protein ( CRP ) generated from spontaneous urine samples from 17 patients of each group .
RESULTS	We were unable to find any significant difference between the two treatment groups with regard to renal toxicity .
RESULTS	All patients , independently of the applied bisphosphonate , experienced only temporary renal dysfunction without any evidence of irreversible damage in terms of acute nephrotoxicity during the study period .
RESULTS	1-Microglobulin , a marker for proximal tubular damage , in particular , was not differently elevated in either group .
CONCLUSIONS	Both applied bisphosphonates were found to be well-tolerated and safe with regard to renal toxicity during a six-month treatment period in patients with otherwise healthy kidneys having advanced breast cancer and bone metastases .

###24925026
BACKGROUND	In adults with Williams-Beuren syndrome ( WBS ) , a common endocrine abnormality is type 2 diabetes mellitus ( T2DM ) or impaired glucose tolerance ( IGT ) .
BACKGROUND	However , few and sporadic data are available in children , adolescents , and young adults with WBS .
OBJECTIVE	To evaluate the frequency of IGT and T2DM in a cohort of children and young patients with WBS .
METHODS	We longitudinally evaluated 27 patients ( 9 males and 18 females , median age at study onset 13.6 years ) with WBS .
METHODS	The median follow-up was 3.6 years .
METHODS	Variables of insulin resistance and - cell function were evaluated in all subjects using an oral glucose tolerance test .
METHODS	The homeostasis model assessment ( HOMA ) of insulin resistance and the Matsuda index of insulin sensitivity were calculated .
METHODS	The study of the GCK and HNF1 genes was performed in patients with glucose metabolism abnormalities .
METHODS	45 age - and sex-matched healthy subjects and 51 age - , sex - and BMI-matched subjects were recruited as two control groups .
RESULTS	Considering nutritional status , 7 ( 25.9 % ) patients were obese , 9 ( 33.3 % ) overweight , and 11 ( 40.8 % ) normal-weight .
RESULTS	One ( 3.1 % ) patient had acanthosis nigricans .
RESULTS	IGT was diagnosed in 7 ( 25.9 % ) WBS patients and T2DM in 3 ( 11.1 % ) .
RESULTS	Considering all WBS patients , the median value of HOMA was 5.23 ( range 2.93-14 .89 ; insulin 24.73 14.67 U/ml ; glucose 104.98 16.06 mg/dl ) .
RESULTS	Considering BMI values , HOMA was 11.00 ( range 6.53-12 .56 ) , 5.64 ( range 3.54-7 .95 ) , and 4.54 ( range 3.21-5 .43 ) , and insulin was 34.53 6.84 , 22.76 8.91 , and 19.47 6.01 U/ml in obese , overweight , and normal-weight WBS patients , respectively .
RESULTS	Comparing the results with the two control groups , WBS patients showed higher insulin values than healthy controls ( p < 0.001 ) , but similar values as the BMI-matched control group ( p = n.s. ) .
RESULTS	However , WBS patients showed significantly higher values of glycemia ( healthy control group , p < 0.001 ; BMI-matched control group , p < 0.05 ) and HOMA ( healthy control group , p < 0.001 ; BMI-matched control group , p < 0.05 ) than the two control groups .
RESULTS	Finally , among WBS patients there was a higher number of subjects with IGT and T2DM than among healthy controls ( p < 0.0001 ) and the BMI-matched control group ( p = 0.0002 ) .
CONCLUSIONS	Our data strongly suggest that IGT and T2DM may be frequently discovered in children , adolescents , and young adults with WBS .
CONCLUSIONS	WBS should be included among the genetic syndromes associated with T2DM .
CONCLUSIONS	Further studies are necessary to evaluate the etiopathogenesis of this aspect .

###25467540
BACKGROUND	With a prevalence of 3 to 8 % among women of reproductive age , severe premenstrual symptoms are very common .
BACKGROUND	Symptoms range from emotional and cognitive to physical changes .
BACKGROUND	Severe symptoms ( that is , premenstrual syndrome ) can have a strong impact on everyday functioning and quality of life .
BACKGROUND	Impairment can be as serious as that of dysthymic disorders .
BACKGROUND	Many affected women receive either no treatment at all or are unsatisfied with their treatment .
BACKGROUND	Although there is some evidence for the reduction of distress through cognitive behavioural therapy , there are only a small number of randomised controlled trials carefully investigating the efficacy of this psychotherapeutic approach .
BACKGROUND	Thus , this study aims to evaluate the efficacy of a cognitive behavioural self-help treatment for women suffering from premenstrual syndrome .
METHODS	The study is conducted as a randomised controlled trial .
METHODS	The complex diagnostic assessment includes the completion of a symptom diary over two consecutive cycles and a telephone interview .
METHODS	Eligible women are randomly assigned to either a treatment or a wait-list control group .
METHODS	The intervention is based on cognitive behavioural therapy principles and is provided via the internet .
METHODS	It consists of 14 different modules on which participants work over 8 consecutive weeks .
METHODS	In addition to written information , participants receive email feedback from a clinical psychologist on a weekly basis .
METHODS	Participants assigned to the wait-list receive the treatment after the end of the waiting period ( 8 weeks ) .
METHODS	The primary outcome measure is the Premenstrual Syndrome Impairment Measure .
METHODS	Secondary outcomes include the Premenstrual Syndrome Coping Measure , the Short-Form Social Support Questionnaire , the Questionnaire for the Assessment of Relationship Quality , and the Perceived Stress Scale .
METHODS	Data is collected during the premenstrual ( luteal ) phase at pre-treatment , post-treatment , and 6-month follow-up .
CONCLUSIONS	So far , there is no study investigating internet-based cognitive behavioural therapy for premenstrual syndrome .
CONCLUSIONS	The programme approaches the problem of high prevalence in combination with severe impairment and insufficient treatment options .
BACKGROUND	ClinicalTrials.gov : NCT01961479 , 9 October 2013 .

###24468255
BACKGROUND	In North America , few studies have evaluated sublingual immunotherapy for allergic rhinitis with or without conjunctivitis ( AR/C ) ; pediatric data are sparse .
BACKGROUND	The authors report findings from the largest published immunotherapy trial yet conducted in adults and children .
OBJECTIVE	To evaluate grass sublingual immunotherapy tablet ( MK-7243 ) treatment in subjects with AR/C .
METHODS	North American subjects ( 5-65 years old ) with grass allergy were randomized 1:1 to once-daily MK-7243 ( 2,800 BAU Phleum pratense ) or placebo .
METHODS	The first dose was given at the investigator 's office ; subsequent doses were self-administered at home .
METHODS	The primary end point was total combined score ( TCS ; rhinoconjunctivitis daily symptom score [ DSS ] plus daily medication score [ DMS ] ) over the entire grass pollen season ( GPS ) .
METHODS	Key secondary end points included entire-season DSS , DMS , peak-season TCS , and rhinoconjunctivitis quality-of-life questionnaire scores .
METHODS	Safety outcomes included adverse events ( AEs ) .
RESULTS	One thousand five hundred one subjects were randomized ( 85 % polysensitized , 25 % had asthma ) .
RESULTS	MK-7243 yielded improvements vs placebo of 23 % in entire-season TCS ( median difference-0 .98 , P < .001 ) , 29 % in peak-season TCS ( median difference-1 .33 , P < .001 ) , 20 % in entire-season DSS ( median difference-0 .64 , P = .001 ) , 35 % in entire-season DMS ( mean difference-0 .48 , P < .001 ) , and 12 % in peak-season rhinoconjunctivitis quality-of-life questionnaire ( median difference-0 .13 , P = .027 ) .
RESULTS	Efficacy between children and adults was similar .
RESULTS	Most AEs were transient local application-site reactions , with no serious treatment-related AEs or anaphylactic shock .
RESULTS	Three subjects ( 1 placebo , 2 MK-7243 ) had moderate systemic allergic reactions .
CONCLUSIONS	MK-7243 was effective in polysensitized grass-allergic North American children and adults with AR/C in this large trial , confirming previous research .

###24423245
BACKGROUND	Pregnant women are the highest priority group for annual influenza vaccination .
BACKGROUND	Studies have shown unacceptably low uptake of both seasonal and pandemic A/H1N1 influenza vaccination among pregnant women .
BACKGROUND	This paper will describe the study protocol and methodology of a randomised controlled trial designed to assess the effectiveness of a brief educational intervention in improving the uptake of seasonal influenza vaccine among pregnant women in Hong Kong .
METHODS	A randomised controlled trial will be conducted with pregnant women in at least the second trimester of pregnancy from four publicly funded hospital antenatal clinics in Hong Kong .
METHODS	Participants will be randomly assigned to either one of the two treatment groups : standard care ( control ) or standard care plus brief education ( intervention ) .
METHODS	Pregnant women in the standard care group will receive the usual antenatal care with an educational pamphlet developed by the Hong Kong Centre for Health Protection and those in the intervention group will be provided with usual care plus a brief ten-minute education intervention .
METHODS	Content of the education session will cover four core components recommended in the research literature .
METHODS	The primary study outcome will be the proportion of participants who have received influenza vaccine during their pregnancy .
METHODS	A total of 184 pregnant women ( 92 per group ) will be required to give an 80 % power to detect a treatment effect of 15 % .
CONCLUSIONS	Most intervention studies aimed at improving influenza vaccination rates in pregnant women have targeted obstetric-care providers and the results of the two patient-oriented RCT interventions are conflicting .
CONCLUSIONS	The high priority for vaccination given to pregnant women and the low influenza vaccination rate among pregnant women worldwide strongly indicates a need for interventions to improve uptake .

###25463415
BACKGROUND	Serious adverse events ( SAEs ) from heart failure ( HF ) therapy are frequent ; however , techniques to identify at-risk patients are inadequate .
BACKGROUND	Furthermore , the relationship between SAEs , quality of life ( QOL ) , and cardiac structure are unknown .
RESULTS	151 symptomatic patients with systolic HF were followed for a mean of 10 months .
RESULTS	In this post hoc analysis , treatment-related SAEs included acute renal failure , dizziness , hypo/hyperkalemia , hypotension , and syncope .
RESULTS	At 1 year , 21 treatment-related SAEs occurred .
RESULTS	No difference in SAEs existed between the N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) - guided arm and the standard of care arm ( P = .20 ) .
RESULTS	At baseline , patients who suffered SAEs were less likely to be receiving beta-blockers ( 85.7 % vs 97.7 % ; P = .009 ) and had worse functional class and lower chloride levels .
RESULTS	Patients who experienced SAEs had less improvement in their Minnesota Living With Heart Failure Questionnaire scores and had a trend toward reduced echocardiographic reverse remodeling over the follow-up period .
RESULTS	Univariable and multivariable analyses were conducted to develop a risk score for SAE prediction ; patients in the highest risk quartile had the shortest time to first cardiovascular event ( P = 0.01 ) .
CONCLUSIONS	NT-proBNP-guided HF care is safe .
CONCLUSIONS	Experiencing treatment-related SAEs is associated with worse QOL and potentially reduced reverse remodeling .
CONCLUSIONS	A risk score to prospectively predict SAEs in aggressive HF management was developed .

###24513094
OBJECTIVE	To investigate risk factors for disc hemorrhage detection in the Low-Pressure Glaucoma Treatment Study .
METHODS	Cohort of a randomized , double-masked , multicenter clinical trial .
METHODS	Low-Pressure Glaucoma Treatment Study patients with at least 16months of follow-up were included .
METHODS	Exclusion criteria included untreated intraocular pressure ( IOP ) of more than 21mm Hg , visual field mean deviation worse than-16 dB , or contraindications to study medications .
METHODS	Patients were randomized to topical treatment with timolol 0.5 % or brimonidine 0.2 % .
METHODS	Stereophotographs were reviewed independently by 2 masked graders searching for disc hemorrhages .
METHODS	The main outcomes investigated were the detection of disc hemorrhage at any time during follow-up and their recurrence .
METHODS	Ocular and systemic risk factors for disc hemorrhage detection were analyzed using the Cox proportional hazards model and were tested further for independence in a multivariate model .
RESULTS	Two hundred fifty-three eyes of 127 subjects ( mean age , 64.7 10.9 years ; women , 58 % ; European ancestry , 71 % ) followed up for an average standard deviation of 40.6 12months were included .
RESULTS	In the multivariate analysis , history of migraine ( hazard ratio [ HR ] , 5.737 ; P = .012 ) , narrower neuroretinal rim width at baseline ( HR , 2.91 ; P = .048 ) , use of systemic - blockers ( HR , 5.585 ; P = .036 ) , low mean systolic blood pressure ( HR , 1.06 ; P = .02 ) , and low mean arterial ocular perfusion pressure during follow-up ( HR , 1.172 ; P = .007 ) were significant and independent risk factors for disc hemorrhage detection .
RESULTS	Treatment randomization was not associated with either the occurrence or recurrence of disc hemorrhages .
CONCLUSIONS	In this cohort of Low-Pressure Glaucoma Treatment Study patients , migraine , baseline narrower neuroretinal rim width , low systolic blood pressure and mean arterial ocular perfusion pressure , and use of systemic - blockers were risk factors for disc hemorrhage detection .
CONCLUSIONS	Randomization assignment did not influence the frequency of disc hemorrhage detection .

###24304090
OBJECTIVE	To investigate the effectiveness of repetitive facilitative exercise ( RFE ) under surface neuromuscular electrical stimulation ( NMES ) in patients with post-stroke hemiplegia .
METHODS	This randomized , controlled , observer-blinded , pilot trial randomized 27 adults with severe arm impairment [ Fugl-Meyer Arm scale ( FMA ) 20 ] due to stroke of 3-13 weeks duration into three groups and provided treatment on a 4-week , 40 minutes/day , 5 days/week schedule .
METHODS	The RFE-under-NMES group were given 100-150 repetitions of standardized movements of shoulder , elbow and wrist joints of their affected arm with concurrent low-amplitude NMES for each corresponding musculature .
METHODS	The RFE group was given the same exercise regimen but without NMES .
METHODS	The control group was treated with a conventional arm rehabilitation programme without NMES .
METHODS	FMA was assessed at baseline and 4 weeks .
RESULTS	All 27 participants ( nine in each group ) completed the trial .
RESULTS	At 4 weeks , the RFE-under-NMES group evidenced significantly greater improvement compared with the control group on the FMA ( p = 0.003 ) , but not with the RFE group ( p = 0.092 ) .
RESULTS	The RFE group showed improvement compared with the control group , but it was not significant ( p = 0.199 ) .
CONCLUSIONS	RFE under NMES is feasible in clinical settings and may be more effective than conventional rehabilitation in lessening arm impairment after sub-acute stroke .

###25479112
OBJECTIVE	In the critically ill undergoing urgent endotracheal intubation by direct laryngoscopy , multiple attempts are often required with a higher complication rate due to the urgency , uncontrolled setting , comorbidities , and variability in expertise of operators .
OBJECTIVE	We hypothesized that Glidescope video laryngoscopy would be superior to direct laryngoscopy during urgent endotracheal intubation .
METHODS	Single-center prospective randomized controlled trial .
METHODS	Beth Israel Medical Center , an 856-bed urban teaching hospital with a 16-bed closed medical ICU .
METHODS	Of 153 consecutive patients undergoing urgent endotracheal intubation by pulmonary and critical care medicine fellows , 117 met inclusion criteria .
METHODS	Patients undergoing urgent endotracheal intubation were randomized to Glidescope video laryngoscopy or direct laryngoscopy as the primary intubation device .
RESULTS	The primary outcome measure was the rate of first-attempt success .
RESULTS	Acute Physiology and Chronic Health Evaluation II scores were similar between groups ( 20.9 8.2 vs 19.9 7.9 ) .
RESULTS	First-attempt success was achieved in 74 % of the Glidescope video laryngoscopy group compared with 40 % in the direct laryngoscopy group ( p < 0.001 ) .
RESULTS	All unsuccessful direct laryngoscopy patients were successfully intubated with Glidescope video laryngoscopy , 82 % on the first attempt .
RESULTS	There was no significant difference in rates of complications between direct laryngoscopy and Glidescope video laryngoscopy : esophageal intubations ( 7 % vs 0 % ; p = 0.05 ) , aspiration events ( 7 % vs 9 % ; p = 0.69 ) , desaturation ( 8 % vs 4 % ; p = 0.27 ) , and hypotension ( 13 % vs 11 % ; p = 0.64 ) .
CONCLUSIONS	Glidescope video laryngoscopy improves the first-attempt success rate during urgent endotracheal intubation performed by pulmonary and critical care medicine fellows when compared with direct laryngoscopy .

###26237830
OBJECTIVE	To observe the efficacy and safety of oral sanhuangwuji powder , anti-rheumatic drugs ( ARDs ) , and ginger-partitioned acupoint stimulation at zusanli ( ST 36 ) on the treatment of rheumatoid arthritis ( RA ) complicated by peptic ulcer .
METHODS	This prospective randomized controlled study included 180 eligible inpatients and outpatients randomly assigned to an ARD treatment ( n. = 60 ) , ginger-partitioned stimulation ( n = 60 ) , or combination treatment ( n = 60 ) .
METHODS	Patients assigned to the ARD group were given oral celecoxib , methotrexate , and esomeprazole .
METHODS	Patients assigned to the ginger-partitioned stimulation group were given ginger-partitioned acupoint stimulation at zusanli ( ST 36 ) in addition to the ARDs .
METHODS	Patients in the combination treatment group were given oral sanhuangwuji powder , ginger-partitioned acupoint stimulation at susanli ( ST 36 ) , and ARDs .
METHODS	All patients were followed up for 2 months to evaluate clinical effects and safety .
METHODS	The study was registered in the World Health Organization database at the General Hospital of Chengdu Military Area Command Chinese People 's Liberation Army ( ChiCTR-TCC12002824 ) .
RESULTS	The combination treatment group had significantly greater improvements in RA symptoms , laboratory outcomes , and gastrointestinal symptom scores , compared with the other groups ( P < 0.05 ) .
RESULTS	The peptic ulcer healing rate in the combination treatment group was significantly greater than that in the ARD treatment group ( 2 = 16.875 , P < 0.05 ) and the ginger-partitioned stimulation group ( 2 = 6.171 , P < 0.05 ) .
CONCLUSIONS	Combination treatment with ginger-partitioned acupoint stimulation at zusanli ( ST 36 ) , oral sanhuangwuji powder , and ARDs had a better clinical effect for RA with complicated peptic ulcer , compared with ARD treatmentalone or in combination with ginger-partitioned acupoint stimulation .

###25150183
OBJECTIVE	Survivors after cardiac arrest ( CA ) exhibits a systemic inflammatory response as part of post-cardiac arrest syndrome ( PCAS ) .
OBJECTIVE	We investigated the association between systemic inflammation and severity of PCAS and whether level of targeted temperature management ( TTM ) modifies level of the inflammatory response .
METHODS	We studied 169 patients included at a single center in the TTM-trial , randomly assigned to TTM at 33 C or 36 C for 24 h. Plasma samples were analyzed for inflammatory markers including interleukin ( IL ) IL-1 , IL-4 , IL-6 , IL-10 , tumor necrosis factor - ( TNF - ) , C-reactive protein ( CRP ) and procalcitonin ( PCT ) at randomization and 24 , 48 and 72 h after CA .
METHODS	Severity of PCAS was assessed by Sequential Organ Failure Assessment ( SOFA ) score .
RESULTS	Plasma levels of both IL-6 and IL-10 determined at randomization correlated with severity of PCAS at day 2 ( r = 0.36 and r = 0.27 , p < 0.001 ) and day 3 ( r = 0.32 and r = 0.22 , p < 0.001 ) .
RESULTS	IL-6 at randomization was an independent predictor of severity of PCAS at day 2 ( p = 0.003 ) and day 3 ( p < 0.0001 ) and was a significantly stronger predictor of severity of PCAS at day 3 compared to CRP ( p = 0.04 ) and PCT ( p = 0.03 ) .
RESULTS	Level of TTM did not modify level of the inflammatory markers IL-1 , IL-6 , TNF - , IL-4 , IL-10 , CRP and PCT , ( p = NS for each inflammatory marker ) .
CONCLUSIONS	Level of inflammatory response was associated with severity of PCAS with IL-6 being consistently and more strongly associated with severity of PCAS than the inflammatory markers CRP and PCT .
CONCLUSIONS	The systemic inflammatory response after CA was not modified by TTM at 33 C or 36 C.

###24989775
BACKGROUND	Potassium-channels in the carotid body and the brainstem are important regulators of ventilation .
BACKGROUND	The BKCa-channel contains response elements for CO , O2 , and CO2 .
BACKGROUND	Its block increases carotid body signalling , phrenic nerve activity , and respiratory drive .
BACKGROUND	GAL-021 , a new BKCa-channel blocker , increases minute ventilation in rats and non-human primates .
BACKGROUND	This study assessed the single-dose safety , tolerability , pharmacokinetics ( PKs ) , and pharmacodynamics ( PDs ) of GAL-021 in healthy volunteers .
METHODS	Thirty subjects participated in a nine-period , randomized , double-blinded , placebo-controlled , crossover , ascending dose , first-in-human study with i.v. infusions of 0.1-0 .96 mg kg ( -1 ) h ( -1 ) for 1 h and intermediate doses up to 4 h.
RESULTS	Adverse event rates were generally similar among dose levels and between placebo - and GAL-021-treated subjects .
RESULTS	At higher GAL-021 doses , a mild/moderate burning sensation at the infusion site occurred during the infusion .
RESULTS	No clinically significant changes in vital signs or clinical chemistries were noted .
RESULTS	Minute ventilation increased ( AUE0-1 h 16 % , P < 0.05 ) and end-tidal carbon dioxide ( [ Formula : see text ] ) decreased ( AUE0-1 h 6 % , P < 0.05 ) during the first hour at 0.96 mg kg ( -1 ) h ( -1 ) with 1/2-maximal [ Formula : see text ] and [ Formula : see text ] - change occurring by 7.5 min .
RESULTS	Drug concentration rose rapidly during the infusion and decreased rapidly initially ( distribution t1/2 of 30 min ) and then more slowly ( terminal t1/2 of 5.6 h ) .
CONCLUSIONS	GAL-021 was safe and generally well tolerated with adverse events comparable with placebo except for an infusion site burning sensation .
CONCLUSIONS	GAL-021 stimulated ventilation at the highest doses suggesting that greater infusion rates may be required for maximum PD effects .
CONCLUSIONS	GAL-021 had PK characteristics consistent with an acute care medication .

###25318408
OBJECTIVE	This study evaluates the efficacy and safety of a sufentanil sublingual tablet system ( SSTS ) for the management of postoperative pain following open abdominal surgery .
METHODS	At 13 hospital sites in the United States , patients following surgery with pain intensity of greater than 4 on an 11-point numerical rating scale were randomized to receive SSTS dispensing a 15-g sufentanil tablet sublingually with a 20-minute lockout or an identical system dispensing a placebo tablet sublingually .
METHODS	Pain intensity scores were recorded at baseline and for up to 72 hours after starting study drug .
METHODS	The primary end point was time-weighted summed pain intensity difference ( SPID ) over 48 hours .
METHODS	Secondary end points included SPID and total pain relief ( TOTPAR ) for up to 72 hours and patient and health care provider global assessments of the method of pain control .
RESULTS	Summed pain intensity difference over 48 hours was significantly higher in the SSTS group than in the placebo group ( least squares mean [ SEM ] , 105.60 [ 10.14 ] vs 55.58 [ 13.11 ] ; P = 0.001 ) .
RESULTS	Mean SPID and TOTPAR scores were significantly higher in the SSTS group at all time points from 1 hour ( SPID ) or 2 hours ( TOTPAR ) until 72 hours ( P < 0.05 ) .
RESULTS	In the SSTS group , patient global assessment and health care provider global assessment ratings of good or excellent were greater than placebo at all time points ( P < 0.01 ) .
RESULTS	Safety parameters , including adverse events and vital signs , were similar for SSTS and placebo .
CONCLUSIONS	These results suggest that SSTS is effective and safe for the management of postoperative pain in patients following open abdominal surgery .

###24509204
OBJECTIVE	To investigate whether sacral nerve stimulation reduces irritable bowel syndrome ( IBS ) - specific symptoms by a randomized , controlled , crossover study .
BACKGROUND	IBS affects 3 % to 22 % of the population worldwide , but most patients continue to have symptoms despite treatment .
METHODS	Patients included from our tertiary center had diarrhea-predominant or mixed IBS , with a minimum baseline IBS symptom score ( Gastrointestinal Syndrome Rating Scale-IBS questionnaire ) of 40 points reduced by a minimum of 30 % during the percutaneous nerve evaluation before permanent implantation .
METHODS	Patients were randomized ( 1:1 ) to have the stimulator ON or OFF for 1 month and then the opposite for another month .
METHODS	Investigators and patients were not informed of the setting .
METHODS	IBS-specific symptoms and quality of life were assessed through bowel diaries and validated questionnaires .
METHODS	Primary endpoint was the IBS-specific symptom score .
RESULTS	Twenty-one patients were randomized .
RESULTS	Ten were eligible for analysis in each group .
RESULTS	IBS-specific symptom scores were significantly reduced during stimulation : the median difference in the ON-OFF group was 12 ( range , -22 to 44 ) and in the OFF-ON group -17.5 ( range , -48 to -1 ) ( P = 0.0009 ) .
RESULTS	IBS-specific quality-of-life scores improved significantly during stimulation : the median difference in the ON-OFF group was 16 ( range , -24 to 69 ) and in the OFF-ON group -42.5 ( range , -77 to 0 ) ( P = 0.0003 ) .
RESULTS	At 1-year follow-up , the median IBS-specific symptom score ( 25 ; range , 13-65 ) was significantly lower than that at baseline ( 62 ; range , 45-80 ) ( P = 0.0001 ) .
CONCLUSIONS	Sacral nerve stimulation significantly reduces symptoms and improves quality of life of highly selected patients with IBS .

###24535626
BACKGROUND	Tenofovir ( TDF ) is associated with phosphaturia and elevated 1,25 dihydroxy vitamin D ( 1,25-OH ( 2 ) D ) .
BACKGROUND	Fibroblast growth factor 23 ( FGF23 ) causes phosphaturia and increases in response to elevated 1,25-OH ( 2 ) D. Vitamin D-binding protein ( VDBP ) binds to 1,25-OH ( 2 ) D , decreasing its biological activity , and is elevated in individuals with higher plasma tenofovir concentrations .
BACKGROUND	We compared FGF23 and VDBP before and after vitamin D3 ( VITD ) supplementation in youths treated with combination antiretroviral therapy ( cART ) containing or not containing TDF .
METHODS	A randomized controlled trial in HIV-positive youths aged 18-25 years enrolled participants based on cART treatment with TDF ( TDF ; n = 118 ) or without TDF ( no-TDF ; n = 85 ) , and randomized within those groups to VITD ( 50,000 IU every 4 weeks ) or placebo ( PL ) .
METHODS	We measured FGF23 and VDBP and calculated free 1,25-OH ( 2 ) D at baseline and week 12 , and compared changes by TDF treatment and VITD randomized group .
RESULTS	At baseline , serum FGF23 concentration showed a quadratic relationship with 1,25-OH ( 2 ) D most pronounced in the TDF group .
RESULTS	At week 12 , total and free 1,25-OH ( 2 ) D increased in the VITD but not PL groups , independent of TDF use .
RESULTS	FGF23 increased in the TDF group receiving VITD , but there was no FGF23 change in the no-TDF group receiving VITD or the PL groups .
RESULTS	The adjusted mean change in FGF23 from baseline to week 12 was 7.7 pg/ml in the TDF/VITD group , compared with -1.7 ( no-TDF/VITD , P = 0.010 ) , -1.3 ( TDF/PL , P = 0.006 ) and 1.1 ( no-TDF/PL , P = 0.035 ) .
CONCLUSIONS	These results suggest that TDF-containing cART may alter the FGF23 response to vitamin D supplementation in HIV-infected youths .
CONCLUSIONS	Clinical trials number : NCT00490412 .

###24920270
BACKGROUND	High level of serum cholesterol is considered to be a major risk factor for cardiovascular disease ( CVD ) .
BACKGROUND	A double-blinded , randomized , placebo-controlled trial was performed to test the hypothesis that a daily intake of Chlorella may improve serum lipid profile through enhancement of serum carotenoid concentration in mildly hypercholesterolemic subjects .
METHODS	Eligible subjects ( n = 63 ) were randomized to either Chlorella ( 5g/day ) or placebo for a double-blinded trial with a 2-week lead-in period and a 4-week intervention period .
METHODS	Serum triglycerides , total cholesterol , lipoproteins , apolipoproteins and carotenoids were assessed at the beginning and the end of the trial .
RESULTS	Compared with the control group , the Chlorella group exhibited remarkable changes in total cholesterol ( Chlorella -1.6 % ; placebo 0.03 % ; P = 0.036 ) , triglycerides ( Chlorella -10.3 % ; placebo 11.9 % ; P = 0.002 ) , lutein/zeaxanthin ( Chlorella 89.6 % ; placebo -1.7 % ; P < 0.0001 ) , and - carotene ( Chlorella 163.6 % ; placebo 15 % ; P < 0.0001 ) .
RESULTS	Improvement of serum lipids was supported by significant reductions of very low-density lipoprotein cholesterol ( Chlorella -11 % ; placebo 11.8 % ; P = 0.006 ) , apolipoprotein B ( Chlorella -1.5 % ; placebo 1.7 % ; P = 0.044 ) , non high-density lipoprotein ( Chlorella -2.6 % ; placebo -0.5 % ; P = 0.032 ) , and high-density lipoprotein/triglycerides ( Chlorella 4.0 % ; placebo -9.5 % ; P = 0.023 ) , suggesting an inhibitory effect of Chlorella on the intestinal absorption of dietary and endogenous lipids .
RESULTS	Further , the changes of serum lipids appeared to be associated with the changes of serum carotenoids .
CONCLUSIONS	Daily consumption of Chlorella supplements provided the potential of health benefits reducing serum lipid risk factors , mainly triglycerides and total cholesterol , in mildly hypercholesterolemic subjects .
CONCLUSIONS	The effect was related to carotenoid consumption .
BACKGROUND	WHO International Clinical Trials Registry Platform KCT0000259 .

###25132143
OBJECTIVE	Zinc sulfate is beneficial in the treatment of epithelial warts .
OBJECTIVE	We conducted this study to compare the efficacy of combination therapy of oral zinc sulfate with conventional treatments in the treatment of vulvar warts .
METHODS	This study was a randomized controlled trial .
METHODS	The sample size was 42 in each group .
METHODS	Women aged 20-50 years were placed by the block randomized method into six groups : the podophyllin - , imiquimod - and cryotherapy-treated groups , and another three groups receiving 8-week combination therapy of 400mg oral zinc sulfate with one of the above-mentioned treatments .
METHODS	Data were analyzed using anova and Fischer 's exact test with spss16 .
RESULTS	A total of 228 patients were recruited and completed the study in six treatment groups .
RESULTS	No significant difference was observed in the response to treatment among these groups .
RESULTS	Relapse after 6 months was significantly higher in the podophyllin - , imiquimod - and cryotherapy-treated patients compared to patients receiving these treatments in combination with oral zinc sulfate ( P < 0.05 ) .
CONCLUSIONS	Combined therapy of oral zinc sulfate with conventional treatments of vulvar warts appears to reduce the relapse rate .

###24739996
BACKGROUND	Laryngoscopy and endotracheal intubation in the presence of cervical spine instability may put patients at risk of cervical cord injury .
BACKGROUND	Nevertheless , the biomechanics of intubation ( cervical spine motion as a function of applied force ) have not been characterized .
BACKGROUND	This study characterized and compared the relationship between laryngoscope force and cervical spine motion using two laryngoscopes hypothesized to differ in force .
METHODS	Fourteen adults undergoing elective surgery were intubated twice ( Macintosh , Airtraq ) .
METHODS	During each intubation , laryngoscope force , cervical spine motion , and glottic view were recorded .
METHODS	Force and motion were referenced to a preintubation baseline ( stage 1 ) and were characterized at three stages : stage 2 ( laryngoscope introduction ) ; stage 3 ( best glottic view ) ; and stage 4 ( endotracheal tube in trachea ) .
RESULTS	Maximal force and motion occurred at stage 3 and differed between the Macintosh and Airtraq : ( 1 ) force : 48.8 15.8 versus 10.4 2.8 N , respectively , P = 0.0001 ; ( 2 ) occiput-C5 extension : 29.5 8.5 versus 19.1 8.7 degrees , respectively , P = 0.0023 .
RESULTS	Between stages 2 and 3 , the motion/force ratio differed between Macintosh and Airtraq : 0.5 0.2 versus 2.0 1.4 degrees/N , respectively ; P = 0.0006 .
CONCLUSIONS	The relationship between laryngoscope force and cervical spine motion is : ( 1 ) nonlinear and ( 2 ) differs between laryngoscopes .
CONCLUSIONS	Differences between laryngoscopes in motion/force relationships are likely due to : ( 1 ) laryngoscope-specific cervical extension needed for intubation , ( 2 ) laryngoscope-specific airway displacement/deformation needed for intubation , and ( 3 ) cervical spine and airway tissue viscoelastic properties .
CONCLUSIONS	Cervical spine motion during endotracheal intubation is not directly proportional to force .
CONCLUSIONS	Low-force laryngoscopes can not be assumed to result in proportionally low cervical spine motion .

###24246508
OBJECTIVE	Surgical resection enhances long-term survival after lung cancer , but survivors face functional deficits and report on poor quality of life long time after surgery .
OBJECTIVE	This study evaluated short and long-term effects of supervised group exercise training on health-related quality of life and physical performance in patients , who were radically operated for lung cancer .
METHODS	A randomized , assessor-blinded , controlled trial was performed on 78 patients undergoing lung cancer surgery .
METHODS	The intervention group ( IG , n = 41 ) participated in supervised out-patient exercise training sessions , one hour once a week for ten weeks .
METHODS	The sessions were based on aerobic exercises with target intensity of 60-80 % of work capacity , resistance training and dyspnoea management .
METHODS	The control group ( CG , n = 37 ) received one individual instruction in exercise training .
METHODS	Measurements consisted of : health-related quality of life ( SF36 ) , six minute walk test ( 6MWT ) and lung function ( spirometry ) , assessed three weeks after surgery and after four and twelve months .
RESULTS	Both groups were comparable at baseline on demographic characteristic and outcome values .
RESULTS	We found a statistically significant effect after four months in the bodily pain domain of SF36 , with an estimated mean difference ( EMD ) of 15.3 ( 95 % CI :4 to 26.6 , p = 0.01 ) and a trend in favour of the intervention for role physical functioning ( EMD 12.04 , 95 % CI : -1 to 25.1 , p = 0.07 ) and physical component summary ( EMD 3.76 , 95 % CI : -0.1 to 7.6 , p = 0.06 ) .
RESULTS	At 12 months , the tendency was reversed , with the CG presenting overall slightly better measures .
RESULTS	We found no effect of the intervention on 6MWT or lung volumes at any time-point .
CONCLUSIONS	Supervised compared to unsupervised exercise training resulted in no improvement in health-related quality of life , except for the bodily pain domain , four months after lung cancer surgery .
CONCLUSIONS	No effects of the intervention were found for any outcome after one year .

###24688085
OBJECTIVE	This prospective randomized Phase II study was designed to evaluate the preventive effect of an oral nutrition supplement composed of beta-hydroxy-beta-methylbutyrate , arginine and glutamine ( beta-hydroxy-beta-methylbutyrate / arginine/glutamine ) on radiation dermatitis in head and neck cancer patients .
METHODS	Forty patients with histologically proven head and neck cancer , treated with concurrent chemoradiotherapy involving cisplatin were recruited .
METHODS	They were randomly assigned to the beta-hydroxy-beta-methylbutyrate / arginine/glutamine supplement treatment group ( Group A ) or the control group that received no supplement ( Group B ) .
METHODS	The primary endpoint of this study was the percentage of patients developing Grade 3 dermatitis .
METHODS	The secondary endpoints were the percentage of patients developing Grade 2 dermatitis , and the duration of each grade of dermatitis relative to the observation period .
RESULTS	The incidence of Grade 3 dermatitis did not differ between the two groups .
RESULTS	However , as secondary endpoints of this study , the incidence of Grade 2 dermatitis was lower in Group A than B ( 62.6 vs. 94.4 % ; P < 0.05 ) , and the duration of Grade 1 dermatitis was shorter in Group A than B ( 44.8 vs. 56.7 % ; P < 0.01 ) , as was the duration of Grade 2 dermatitis ( 16.5 vs. 26.5 % ; P < 0.05 ) .
CONCLUSIONS	Our study indicated that beta-hydroxy-beta-methylbutyrate / arginine/glutamine supplementation was potentially effective in the prevention of radiation dermatitis in head and neck cancer patients .

###24607076
OBJECTIVE	Applied Kinesiology ( AK ) is a diagnostic technique widely used within the Integrative Medical community .
OBJECTIVE	In essence , it posits that a question can be mentally held in a person 's mind , sometimes while they are holding a substance like a vitamin , or a food sample , and by measuring relative muscular weakness an answer as to whether the substance or the condition represented by the question is good for that person can be obtained .
OBJECTIVE	This AK is presumed to have a diagnostic capability .
OBJECTIVE	That being presumed , this study asks the following questions : ( 1 ) Is there a difference in muscular strength when an individual holds a substance that is inimical to life processes ( a poison solution ) , as compared to a substance that is essential for life ( normal saline ) ?
OBJECTIVE	( 2 ) Is this effect a transaction involving input from both the person being measured and the kinesiologist doing the measurement or is it only the person being measured ?
OBJECTIVE	( 3 ) As an extension of question 2 , is the result the same when different kinesiologists take the measurement or when no kinesiologist is involved ?
OBJECTIVE	( 4 ) Does belief , expectation , gender , or time cognition play a role in determining response ?
METHODS	To answer these questions , which would help to define the parameters of the AK process , 51 participants were tested during three trials each , first by one kinesiologist , then by another , and finally , with no kinesiologist present by grip strength indicated using a hand dynamometer .
METHODS	Grip strength being a self-administered AK test of relative muscular strength .
METHODS	For each trial , a pair of randomly numbered sealed vials , each pair in a randomly numbered plastic bag , were used as the objects of the trial .
METHODS	In each bag , one vial contained saline solution while the other was filled with a slightly smaller amount of saline solution to which had been added ionic hydroxylamine hydrochloride ( NH3OH ) ( + ) , producing a toxic solution of 9mg/ml .
METHODS	Each trial consisted of a separate muscle test for each vial .
METHODS	All present at the trials were blind as to which vial contained the toxin .
METHODS	And all who prepared the vials were blind to the trials .
METHODS	The force used by the kinesiologists in each of their trials was measured via a pressure pad system .
METHODS	The hand dynamometer trials were conducted with no kinesiologist present .
RESULTS	Of the 151 sets of trials , the toxic vial was identified correctly in 80 of them ( 53 % ) , resulting in a one-tailed exact binomial P-value of .258 .
RESULTS	Results for two of the kinesiologists were almost exactly at chance .
RESULTS	For the third kinesiologist , there was a one-tailed exact binomial P-value of .18 ( unadjusted for multiple testing ) .
RESULTS	Results for the dynamometer were also almost exactly at chance .
RESULTS	Testing whether there was a significant difference in proportions for whom the AK test worked based on belief about whether it would work resulted in non-significant ( 2 ) values of 0.6 ( P = .439 ) for the trials with one kinesiologist and 2.222 ( P = .136 ) for the hand dynamometer trials .
RESULTS	The final variable examined was gender .
RESULTS	While there was no significant difference in performance for males and females for the trials of the male kinesiologist or the hand dynamometer , the combined data for the two female kinesiologists did reveal a difference .
RESULTS	Of the 33 sessions with females , only 15 were successful ( 45 % ) , while for the 18 sessions with males , 14 were successful ( 78 % ) , resulting in a ( 2 ) statistic of 4.96 , P = .026 .
RESULTS	However , given all of the ( 2 ) tests performed in this section , the results must be interpreted with caution because of multiple testing .
RESULTS	Results indicate belief in whether the AK test will work was not significantly related to whether it actually did work .
RESULTS	A ( 2 ) test of the relationship between time perception and correct vial choice showed no significant relationships .
RESULTS	The ( 2 ) statistic for the relationship using the hand dynamometer data was 0.927 , P = .629 .
CONCLUSIONS	The data in this study , particularly when seen in the larger context of a review of the literature from the AK field itself by Klinkoski and Leboeuf ( 1990 ) , which considered 50 papers published between 1981 and 1987 by the International College of Applied Kinesiology , and the survey by Hall , Lewith , Brien , and Little ( 2008 ) , using standard evaluation criteria [ quality assessment tool for studies of diagnostic accuracy included in systematic reviews ( QUADAS ) , Standards for Reporting of Diagnostic Studies ( STARD ) , JADAD , and Consolidated Standards of Reporting Trials ( CONSORT ) ] , for research methodology , as well as six prior non-clinical studies by Radin ( 1984 ) , Quintanar and Hill ( 1988 ) , Braud ( 1989 ) , Arnett et al. ( 1999 ) , Ludtke ( 2001 ) , and Kendler and Keating ( 2003 ) , all together suggest the following : The research published by the Applied Kinesiology field itself is not to be relied upon , and in the experimental studies that do meet accepted standards of science , Applied Kinesiology has not demonstrated that it is a useful or reliable diagnostic tool upon which health decisions can be based .

###24504761
OBJECTIVE	The phosphodiesterase type 5 inhibitor tadalafil is approved for the treatment of signs and symptoms of benign prostatic hyperplasia ( BPH ) .
OBJECTIVE	While tadalafil significantly improves overall lower urinary tract symptoms suggestive of BPH ( LUTS/BPH ) , improvements in nocturia were not significant in individual studies .
OBJECTIVE	We therefore sought to further assess nocturia based on data integrated from four tadalafil registrational studies .
METHODS	Data were integrated from four randomized , placebo-controlled , double-blind , 12-week registrational studies of tadalafil for LUTS/BPH .
METHODS	Nocturia was assessed as nighttime voiding frequency using the International Prostate Symptom Score question 7 ( IPSS Q7 ) .
METHODS	Efficacy results were analyzed using analysis of covariance .
RESULTS	For the tadalafil 5 mg once daily ( N = 752 ) and placebo ( N = 748 ) groups , baseline characteristics were well balanced , and the overall severity of nocturia per mean IPSS Q7 was 2.3 1.2 .
RESULTS	The mean treatment change was -0.4 with placebo and -0.5 with tadalafil ; the least-squares mean ( standard error ) treatment difference was -0.2 ( 0.05 ) , p = 0.002 .
RESULTS	For patients receiving placebo and tadalafil , respectively , the proportion with improved nocturnal frequency was 41.3 and 47.5 % , with no change was 44.8 and 41.0 % , and with worsening was 13.9 and 11.5 % .
CONCLUSIONS	A statistically significant improvement in nocturnal frequency was seen with tadalafil over placebo ; however , the treatment difference was small and not considered clinically meaningful .
CONCLUSIONS	Further studies using voiding diaries and excluding patients with nocturnal polyuria would be needed to more precisely estimate the impact of tadalafil on nocturia associated with LUTS/BPH .

###25422824
OBJECTIVE	To evaluate whether 6.6-mm long implants could be a suitable alternative to longer implants placed in vertically augmented atrophic posterior mandibles .
METHODS	Sixty partially edentulous patients having 7 to 8 mm of residual crestal height and at least 5.5 mm thickness measured on CT scans above the mandibular canal were randomised according to a parallel group design .
METHODS	They were either to receive 1 to 3 submerged 6.6-mm long implants or 9.6 mm or longer implants ( 30 patients per group ) placed in vertically augmented bone .
METHODS	Bone was augmented with interpositional anorganic bovine bone blocks covered by resorbable barriers .
METHODS	Grafts were left to heal for 5 months before implant placement .
METHODS	Four months after provisional acrylic prostheses were delivered , they were replaced , after 4 months , by definitive metal-ceramic prostheses .
METHODS	Outcome measures were : prosthesis and implant failures ; complications ; and radiographic peri-implant marginal bone level changes .
METHODS	All patients were followed up to 5 years after loading .
RESULTS	Five years after loading , 8 patients dropped out : 3 from the short implant group and 5 from the augmented group .
RESULTS	The augmentation procedure failed in 2 patients and only 6.6-mm long implants could be inserted .
RESULTS	There were no statistically significant differences for prosthesis and implant failures .
RESULTS	Five prostheses failed in 4 patients of the short implant group versus 5 prostheses in 5 patients in the augmented group ( Fishers exact test P = 1.0 ; difference in proportions = 0.07 ; 95 % CI -0.29 to 0.43 ) .
RESULTS	Five short implants failed in 3 patients versus 3 long implants in 3 patients ( Fishers exact test P = 1.00 difference in proportions = 0.00 ; 95 % CI -0.43 to 0.43 ) .
RESULTS	There were statistically more complications in augmented patients ( 25 complications in 21 augmented patients versus 6 complications in 6 patients of the short implant group ) ( Fishers exact test P < 0.0001 ; difference in proportions = 0.60 ; 95 % CI 0.38 , 0.82 ) .
RESULTS	Both groups gradually lost peri-implant bone in a statistically significant way .
RESULTS	Five years after loading , short implant group patients lost an average of 1.49 mm peri-implant bone compared with 2.34 mm in the augmented group .
RESULTS	Short implants experienced statistically significantly less bone loss ( 0.82 mm , 95 % CI 0.48 ; 1.16 , P < 0.0001 ) than long implants .
CONCLUSIONS	When residual bone height over the mandibular canal is between 7 to 8 mm , 6.6 mm short implants could be an interesting alternative to vertical augmentation in posterior atrophic mandibles since the treatment is faster , cheaper and associated with less morbidity .
CONCLUSIONS	Longer follow-ups may still be needed to confirm these results , however the medium-term prognosis ( 5 years after loading ) of short implants is at least as good as those of longer implants placed vertically in augmented mandibles .

###25380007
BACKGROUND	Pilonidal sinus disease is associated with significant morbidity after surgical treatment with regard to wound healing .
BACKGROUND	Recent case studies suggested that negative-pressure wound therapy as primary treatment following surgical excision may shorten the duration of wound healing .
OBJECTIVE	The purpose of this randomized controlled trial was to evaluate the role of vacuum therapy in pilonidal sinus disease : negative-pressure wound therapy versus standard open wound care after surgical excision .
METHODS	Patients were randomly assigned to either negative-pressure wound therapy for 2 weeks or standard open wound healing .
METHODS	The primary end point of the study was the time to complete wound healing .
METHODS	Secondary end points were visual analog scale score , wound size ratio at day 14 ( ie , wound healing rate ) , time to resume daily activities , and recurrence within 6 months after wound closure .
RESULTS	Forty-nine patients were included in the study : 24 patients were treated with vacuum therapy , and 25 patients underwent standard open wound care .
RESULTS	Complete wound healing was achieved at a median of 84 days in the vacuum therapy group versus 93 days in control patients ( p = 0.44 ) .
RESULTS	The wound size ratio was significantly lower in the vacuum therapy group ( 0.30 versus 0.57 , p = 0.02 ) , ie , higher wound healing rate in the first 2 weeks .
RESULTS	There was no difference in visual analog scale scores and disease recurrence between both groups .
RESULTS	The time to resume full daily activities after surgery was 27 days in the patients undergoing vacuum therapy and 29 days in the control patients ( p = 0.92 ) .
CONCLUSIONS	This study is limited by the small number of patients , the lack of blinding to patients and doctors , and the absence of patient quality-of-life evaluation .
CONCLUSIONS	It is feasible to apply vacuum therapy in the treatment of pilonidal sinus disease , and it has a positive effect on wound size reduction in the first 2 weeks .
CONCLUSIONS	However , there is no difference in time to complete wound healing and time to resume daily life activities .

###24466245
BACKGROUND	Plasmodium falciparum malaria is treated with 25 mg/kg of chloroquine ( CQ ) irrespective of age .
BACKGROUND	Theoretically , CQ should be dosed according to body surface area ( BSA ) .
BACKGROUND	The effect of dosing CQ according to BSA has not been determined but doubling the dose per kg doubled the efficacy of CQ in children aged < 15 years infected with P. falciparum carrying CQ resistance causing genes typical for Africa .
BACKGROUND	The study aim was to determine the effect of age on CQ concentrations .
RESULTS	Day 7 whole blood CQ concentrations were determined in 150 and 302 children treated with 25 and 50 mg/kg , respectively , in previously conducted clinical trials .
RESULTS	CQ concentrations normalised for the dose taken in mg/kg of CQ decreased with decreasing age ( p < 0.001 ) .
RESULTS	CQ concentrations normalised for dose taken in mg/m ( 2 ) were unaffected by age .
RESULTS	The median CQ concentration in children aged < 2 years taking 50 mg/kg and in children aged 10-14 years taking 25 mg/kg were 825 ( 95 % confidence interval [ CI ] 662-988 ) and 758 ( 95 % CI 640-876 ) nmol/l , respectively ( p = 0.67 ) .
RESULTS	The median CQ concentration in children aged 10-14 taking 50 mg/kg and children aged 0-2 taking 25 mg/kg were 1521 and 549 nmol/l .
RESULTS	Adverse events were not age/concentration dependent .
CONCLUSIONS	CQ is under-dosed in children and should ideally be dosed according to BSA .
CONCLUSIONS	Children aged < 2 years need approximately double the dose per kg to attain CQ concentrations found in children aged 10-14 years .
CONCLUSIONS	Clinical trials assessing the efficacy of CQ in Africa are typically performed in children aged < 5 years .
CONCLUSIONS	Thus the efficacy of CQ is typically assessed in children in whom CQ is under dosed .
CONCLUSIONS	Approximately 3 fold higher drug concentrations can probably be safely given to the youngest children .
CONCLUSIONS	As CQ resistance is concentration dependent an alternative dosing of CQ may overcome resistance in Africa .

###25427305
OBJECTIVE	To compare the safety and efficacy of fibrin glue and cyanoacrylate glue for refixating the recessed muscle to the sclera in patients undergoing strabismus surgery .
METHODS	In this prospective , randomized , and interventional case series , there were 15 patients in each group .
METHODS	Two different types of glue were used for refixating the muscle to the sclera after its recession : fibrin glue ( fibrin group ) and cyanoacrylate glue ( cyanoacrylate group ) .
METHODS	Resection was performed as usual with a 6-0 polyglactin suture .
METHODS	The conjunctiva was closed with the same glue that was used for muscle recession .
RESULTS	Average time required per muscle attachment was 1.480.694 minutes in the fibrin group and 2.420.584 minutes in the cyanoacrylate group .
RESULTS	There was no significant difference in pain at all postoperative visits in both groups .
RESULTS	Significantly more chemosis was observed in the cyanoacrylate group at postoperative 3 weeks .
RESULTS	At all other postoperative visits , there was no significant difference in chemosis in both groups .
RESULTS	There was significantly more conjunctival reaction in the cyanoacrylate group at 1 and 3 weeks and 3 months ; the difference was highly significant at 3 months ( P = .00 ) .
RESULTS	Total inflammatory score was significantly high in the cyanoacrylate group at 1 week , 3 weeks , and 3 months .
CONCLUSIONS	Both fibrin and cyanoacrylate glue are equally efficacious for muscle reattachment ; however , fibrin glue is more biotolerant compared to cyanoacrylate glue and results in less postoperative inflammation , and is thus recommended for recession in strabismus surgery .

###24874483
BACKGROUND	Stratification of patients for treatment of ductal carcinoma in situ ( DCIS ) is suboptimal , with high systemic overtreatment rates .
METHODS	A training set of 95 tumours from women with pure DCIS were immunostained for proteins involved in cell survival , hypoxia , growth factor and hormone signalling .
METHODS	A generalised linear regression with regularisation and variable selection was applied to a multiple covariate Cox survival analysis with recurrence-free survival 10-fold cross-validation and leave-one-out iterative approach were used to build and test the model that was validated using an independent cohort of 58 patients with pure DCIS .
METHODS	The clinical role of a COX-2-targeting agent was then tested in a proof-of-concept neoadjuvant randomised trial in ER-positive DCIS treated with exemestane 25 mg day ( -1 ) celecoxib 800 mg day ( -1 ) .
RESULTS	The COX-2 expression was an independent prognostic factor for early relapse in the training ( HR 37.47 ( 95 % CI : 5.56-252 .74 ) P = 0.0001 ) and independent validation cohort ( HR 3.9 ( 95 % CI : 1.8-8 .3 ) P = 0.002 ) .
RESULTS	There was no significant interaction with other clinicopathological variables .
RESULTS	A statistically significant reduction of Ki-67 expression after treatment with exemestane celecoxib was observed ( P < 0.02 ) with greater reduction in the combination arm ( P < 0.004 ) .
RESULTS	Concomitant reduction in COX-2 expression was statistically significant in the exemestane and celecoxib arm ( P < 0.03 ) only .
CONCLUSIONS	In patients with DCIS , COX-2 may predict recurrence , aiding clinical decision making .
CONCLUSIONS	A combination of an aromatase inhibitor and celecoxib has significant biological effect and may be integrated into treatment of COX2-positive DCIS at high risk of recurrence .

###25631721
OBJECTIVE	The objective of the present study was to investigate the effect of probiotic Lactobacillus casei Shirota on the values of mutans streptococci counts in saliva .
METHODS	31 children were included in this double blinded study .
METHODS	Study design included 4 periods which consisted of a run in period , two intervention periods and a washout period .
METHODS	During the intervention periods children were either given probiotic milk or control milk for 10 days .
METHODS	Pre and post intervention salivary samples were subjected to microbiological evaluation .
METHODS	Then numbers of mutans streptococci were taken by identifying colony morphology .
RESULTS	A statistically significant reduction of mutans streptococci colony count was noted in the probiotic group ( p = .003 ) .
RESULTS	The reduction in children with higher levels of mutans streptococci ( 105 ) after intervention was 34 % in the probiotic group .
CONCLUSIONS	Daily consumption of milk containing probiotic bacteria can reduce the levels of mutans streptococci and may contribute to the prevention of dental caries .

###24667057
OBJECTIVE	This study introduces a new device to facilitate perforation size measurement during `` butterfly '' myringoplasty .
OBJECTIVE	The purpose of this study is to evaluate the use of ` otological compass ' on short-term results of inlay cartilaginous ` butterfly ' tympanoplasty technique in adult patients .
METHODS	Prospective , randomized , controlled , blinded .
METHODS	This study included 25 patients who underwent inlay cartilage myringoplasty .
METHODS	All operations were performed under general anesthesia by the same surgeon with a microscope-assisted approach .
METHODS	The patients were divided randomly and consecutively into two groups : Group 1 ( n = 12 ) had perforation dimensions and shape measured using the Otologic Compass ( OC ) and the control group ( n = 13 ) had perforation measured by means of a Fisch elevator .
METHODS	The duration of surgery , number of trials for correct placement of the cartilage graft , results and complications of the surgery were evaluated and compared .
RESULTS	The mean follow-up duration was 6 months .
RESULTS	Groups were similar in terms of age and perforation diameters ( p > 0.05 ) .
RESULTS	Average number of cartilage shaping before satisfactory graft fitting was significantly fewer in the OC group : 1.1 0.3 and 2.2 0.6 trials for OC and control groups , respectively ( p < 0.001 ) .
RESULTS	Mean duration of preparation and satisfactory graft fitting was 9.6 4.2 minutes in the OC group whereas it was 18.1 5.2 minutes for the control group .
RESULTS	Operative duration was significantly shorter in the OC group ( p < 0.001 ) .
RESULTS	At the end of the follow-up period , successful closure occurred 91.7 % and 84.6 % patients in the OC and control groups , respectively ( p > 0.05 ) .
RESULTS	The mean preoperative to postoperative three-tone air-bone gap improved 7.9 dB and 9.0 dB in OC and control groups , respectively ( p > 0.05 ) .
CONCLUSIONS	This study shows that OC presents as a useful tool that expedites and refines butterfly myringoplasty procedure .
CONCLUSIONS	The number of cartilage shaping prior to satisfactory graft fitting revealed significantly better results : almost all surgeries in the OC group were complete after a single cartilage shaping attempt .

###25421518
BACKGROUND	Attrition is common in alcohol clinical trials and the resultant loss of data represents an important methodological problem .
BACKGROUND	In the absence of a simulation study , the drinking outcomes among those who are lost to follow-up are not known .
BACKGROUND	Individuals who drop out of treatment and continue to provide drinking data , however , may be a reasonable proxy group for making inferences about the drinking outcomes of those lost to follow-up .
METHODS	We used data from the COMBINE study , a multisite , randomized clinical trial , to examine drinking during the 4months of treatment among individuals who dropped out of treatment but continued to provide drinking data ( i.e. , `` treatment dropouts ; '' n = 185 ) .
METHODS	First , we estimated the observed treatment effect size for naltrexone versus placebo in a sample that included both treatment completers ( n = 961 ) and treatment dropouts ( n = 185 ; total N = 1,146 ) , as well as the observed treatment effect size among just those who dropped out of treatment ( n = 185 ) .
METHODS	In both the total sample ( N = 1,146 ) and the dropout sample ( n = 185 ) , we then deleted the drinking data after treatment dropout from those 185 individuals to simulate missing data .
METHODS	Using the deleted data sets , we then estimated the effect of naltrexone on the continuous outcome percent heavy drinking days using 6 methods to handle missing data ( last observation carried forward , baseline observation carried forward , placebo mean imputation , missing = heavy drinking days , multiple imputation ( MI ) , and full information maximum likelihood [ FIML ] ) .
RESULTS	MI and FIML produced effect size estimates that were most similar to the true effects observed in the full data set in all analyses , while missing = heavy drinking days performed the worst .
CONCLUSIONS	Although missing drinking data should be avoided whenever possible , MI and FIML yield the best estimates of the treatment effect for a continuous outcome measure of heavy drinking when there is dropout in an alcohol clinical trial .

###25306292
BACKGROUND	There is evidence that neurofibrillary tangle ( NFT ) burden is associated with psychotic symptoms in Alzheimer disease ( AD ) .
BACKGROUND	However , it is not clear whether this association is direct or mediated through the increased cognitive impairment associated with NFTs .
METHODS	We sought to determine whether the extended MAPT haplotype was associated with the worsening of delusions and hallucinations in a combined cohort of 95 patients who participated in 2 clinical trials of treatment with memantine .
RESULTS	After controlling for baseline dementia severity , exposure to memantine , and antipsychotics , analysis shows that carriers of at least one H2 allele had a 5.4-fold ( P = .03 ) increased risk of worsening hallucinations .
RESULTS	There was some evidence of association with worsening delusions but only in analysis by allele .
CONCLUSIONS	These results are the first to indicate that the H2 allele of the extended MAPT haplotype negatively affects the course of psychotic symptoms in AD independently of disease severity .
CONCLUSIONS	It will be important for future research to examine MAPT transcription in people with AD with and without psychotic symptoms to understand the exact mechanisms underlying these findings .

###24585900
BACKGROUND	We introduced an initial large dose of modified St. Thomas ' Hospital cardioplegic solution with the aim of providing both myocardial protection as well as a smooth intraoperative process .
METHODS	In 90 cases of isolated aortic valve replacement , we used the modified technique of cardioplegia in 45 ( group S ) and conventional administration of glucose-insulin-potassium solution in 45 ( group G ) .
METHODS	The patients were selected at random .
METHODS	In group S , we added 4 mEq of potassium to the original St. Thomas ' Hospital solution and administered 30mLkg ( -1 ) as an initial dose .
METHODS	The temperature was decreased to 2 .
RESULTS	The mean of reperfusion time after declamping in group S was significantly shorter ( 16.7 6.4 vs. 21.5 10.0 min ; p = 0.007 ) .
RESULTS	The average of postoperative maximum creatine kinase-MB was significantly lower in group S ( 25.6 9.5 vs. 40.6 37.2 IUL ( -1 ) ; p = 0.014 ) .
RESULTS	On multivariate analysis , use of the modified cardioplegia and aortic crossclamp time were significantly associated with creatine kinase-MB level and reperfusion time after declamping .
CONCLUSIONS	This modified technique was an acceptable option that provided a bloodless operative field and avoided multiple cardioplegic administrations .

###25029202
BACKGROUND	Vitamin D and its metabolites have potent immunomodulatory effects in vitro , including up-regulation of cathelicidin , a critical antimicrobial protein .
OBJECTIVE	We investigated whether administration of 1,25-dihydroxyvitamin D ( calcitriol ) to critically ill patients with sepsis would have beneficial effects on markers of innate immunity , inflammation , and kidney injury .
METHODS	We performed a double-blind , randomized , placebo-controlled , physiologic study among 67 critically ill patients with severe sepsis or septic shock .
METHODS	Patients were randomized to receive a single dose of calcitriol ( 2 g intravenously ) versus placebo .
METHODS	The primary outcome was plasma cathelicidin protein levels assessed 24 hours after study drug administration .
METHODS	Secondary outcomes included leukocyte cathelicidin mRNA expression , plasma cytokine levels ( IL-10 , IL-6 , tumor necrosis factor - , IL-1 , and IL-2 ) , and urinary kidney injury markers .
RESULTS	Patients randomized to calcitriol ( n = 36 ) versus placebo ( n = 31 ) had similar plasma cathelicidin protein levels at 24 hours ( P = 0.16 ) .
RESULTS	Calcitriol-treated patients had higher cathelicidin ( P = 0.04 ) and IL-10 ( P = 0.03 ) mRNA expression than placebo-treated patients 24 hours after study drug administration .
RESULTS	Plasma cytokine levels ( IL-10 , IL-6 , tumor necrosis factor - , IL-1 , and IL-2 ) and urinary kidney injury markers were similar in calcitriol - versus placebo-treated patients ( P > 0.05 for all comparisons ) .
RESULTS	Calcitriol had no effect on clinical outcomes nor were any adverse effects observed .
CONCLUSIONS	Calcitriol administration did not increase plasma cathelicidin protein levels in critically ill patients with sepsis and had mixed effects on other immunomodulatory markers .
CONCLUSIONS	Additional phase II trials investigating the dose and timing of calcitriol as a therapeutic agent in specific sepsis phenotypes may be warranted .
CONCLUSIONS	Clinical trial registered with www.clinicaltrials.gov ( NCT 01689441 ) .

###24565357
OBJECTIVE	We report active treatment group differences on response and remission rates and changes in anxiety severity at weeks 24 and 36 for the Child/Adolescent Anxiety Multimodal Study ( CAMS ) .
METHODS	CAMS youth ( N = 488 ; 74 % 12 years of age ) with DSM-IV separation , generalized , or social anxiety disorder were randomized to 12 weeks of cognitive-behavioral therapy ( CBT ) , sertraline ( SRT ) , CBT+SRT ( COMB ) , or medication management/pill placebo ( PBO ) .
METHODS	Responders attended 6 monthly booster sessions in their assigned treatment arm ; youth in COMB and SRT continued on their medication throughout this period .
METHODS	Efficacy of COMB , SRT , and CBT ( n = 412 ) was assessed at 24 and 36 weeks postrandomization .
METHODS	Youth randomized to PBO ( n = 76 ) were offered active CAMS treatment if nonresponsive at week 12 or over follow-up and were not included here .
METHODS	Independent evaluators blind to study condition assessed anxiety severity , functioning , and treatment response .
METHODS	Concomitant treatments were allowed but monitored over follow-up .
RESULTS	The majority ( > 80 % ) of acute responders maintained positive response at both weeks 24 and 36 .
RESULTS	Consistent with acute outcomes , COMB maintained advantage over CBT and SRT , which did not differ , on dimensional outcomes ; the 3 treatments did not differ on most categorical outcomes over follow-up .
RESULTS	Compared to COMB and CBT , youth in SRT obtained more concomitant psychosocial treatments , whereas those in SRT and CBT obtained more concomitant combined ( medication plus psychosocial ) treatment .
CONCLUSIONS	COMB maintained advantage over CBT and SRT on some measures over follow-up , whereas the 2 monotherapies remained indistinguishable .
CONCLUSIONS	The observed convergence of COMB and monotherapy may be related to greater use of concomitant treatment during follow-up among youth receiving the monotherapies , although other explanations are possible .
CONCLUSIONS	Although outcomes were variable , most CAMS-treated youth experienced sustained treatment benefit .
CONCLUSIONS	Clinical trial registration information-Child and Adolescent Anxiety Disorders ( CAMS ) ; URL : http://clinicaltrials.gov .
CONCLUSIONS	Unique identifier : NCT00052078 .

###24262616
OBJECTIVE	The aim of the study was to compare long-term follow-up results of crush versus culotte stent techniques in coronary bifurcation lesions .
BACKGROUND	The randomized Nordic Stent Technique Study showed similar 6-month clinical and 8-month angiographic results with the crush and culotte stent techniques of de novo coronary artery bifurcation lesions using sirolimus-eluting stents .
BACKGROUND	Here , we report the 36-month efficacy and safety of the Nordic Stent Technique Study .
METHODS	A total of 424 patients with a bifurcation lesion were randomized to stenting of both main vessel and side branch with the crush or the culotte technique and followed for 36 months .
METHODS	Major adverse cardiac events-the composite of cardiac death , myocardial infarction , stent thrombosis , ortarget vessel revascularization-were the primary endpoint .
RESULTS	Follow-up was complete for all patients .
RESULTS	At 36 months , the rates of the primary endpoint were 20.6 % versus 16.7 % ( p = 0.32 ) , index lesion restenosis 11.5 % versus 6.5 % ( p = 0.09 ) , and definitestent thrombosis 1.4 % versus 4.7 % ( p = 0.09 ) in the crush and the culotte groups , respectively .
CONCLUSIONS	At 36-month follow-up , the clinical outcomes were similar for patients with coronary bifurcation lesions treated with the culotte or the crush stent technique .
CONCLUSIONS	( Nordic Bifurcation Study .
CONCLUSIONS	How to Use Drug Eluting Stents [ DES ] in Bifurcation Lesions ?
CONCLUSIONS	NCT00376571 ) .

###24222526
BACKGROUND	The incidence of chronic pain is higher among immigrants in Europe than among the native European population .
BACKGROUND	Therapeutic interventions in this population are far less effective than in patients for whom these programmes were originally developed .
OBJECTIVE	In a randomised trial , we investigated whether a cognitive behavioural treatment ( CBT ) programme supplemented with culturally sensitive aspects ( CsCBT ) improves pain intensity , pain disability and quality of life among immigrant patients , compared with a treatment of culturally sensitive exercise therapy ( CsET ) alone .
OBJECTIVE	Furthermore , we investigated whether healthcare costs would decrease .
METHODS	First-generation Turkish immigrants residing in Switzerland ( 20-65 years of age ) who suffered from chronic pain were enrolled in the trial .
METHODS	Patients were randomised to attend either CsCBT or CsET .
METHODS	The CsCBT intervention was based upon a manualised cognitive-behavioural group treatment programme for chronic pain patients and adapted to the needs of a Turkish immigrant population .
METHODS	The CsET intervention was based on principles of exercise therapy for treatment of nonspecific low back pain .
RESULTS	A total of 116 outpatients were recruited between October 2004 and November 2006 .
RESULTS	The intervention was completed by 89 patients ( 77 % ) .
RESULTS	A total of 78 subjects ( 67 % ) completed follow-up , 12 months after the completion of the intervention programme .
RESULTS	The intervention showed no effects in reducing pain , pain disability or quality of life .
RESULTS	The analysis of healthcare utilisation yielded no intervention effect .
CONCLUSIONS	Cognitive behavioural intervention is feasible with immigrants with chronic disabling pain , but the evidence-based CBT programme , as well as exercise therapy supplemented with culturally sensitive aspects , showed no improvement .

###25462656
OBJECTIVE	The objectives of this randomized , single-blinded , placebo-controlled pilot trial were to investigate the effects of varenicline on opioid withdrawal among chronic pain patients undergoing opioid detoxification in an interdisciplinary pain program and the feasibility of varenicline use in this population .
METHODS	Twenty-one patients were recruited ( varenicline = 10 , placebo = 11 ) , and 7 patients in the varenicline and 11 in the placebo group completed the study .
METHODS	Opioid withdrawal was quantified using the Clinical Opiate Withdrawal Scale , and varenicline-related adverse effects were assessed .
RESULTS	Opioid withdrawal scores tended to decrease over the course of opioid tapering in those receiving varenicline and increase in those receiving placebo .
RESULTS	Varenicline was well-tolerated in this population , with no adverse drug effects ( including nausea ) observed and no effect on improvements in pain severity and depression .
CONCLUSIONS	This randomized pilot study provides preliminary data for future trials of varenicline in opioid-dependent adults with chronic pain undergoing medically directed opioid detoxification .

###24305423
BACKGROUND	Natural ultraviolet exposure induces hair damage , which is difficult to avoid .
BACKGROUND	Most of the research work is focused on the effect of ultraviolet on the epidermis , dermis as well as the immune system , whereas the long-term effect of ultraviolet on hair has not been investigated .
OBJECTIVE	we performed our experiment to find out the changes induced in hair follicle and shaft in those patients exposed to high doses of ultraviolet ( A and B ) during treatment of other skin conditions .
METHODS	Light and transmission electron microscopy examination of scalp hair follicles and shafts of 10 patients with vitiligo under psoralen plus ultraviolet A ( group 1 ) and 10 patients with vitiligo under narrow band ultraviolet B ( group 2 ) was carried out and compared with those of 10 healthy volunteers ( group 3 ) .
RESULTS	Physical changes in the appearance of hair were more in groups 1 and 2 than control .
RESULTS	Reduced hair follicle thickness and perifollicular infiltrate and hyaline disorganized perifollicular collagen were observed more in group 1 than in group 2 with the absence of these changes in group 3 .
RESULTS	Transmission electron microscopy showed nonspecific cell injury in hair follicles in group 1 more than the other 2 groups , while the damaging effect on hair was more in the second group than the others .
CONCLUSIONS	Due to the damaging effect of ultraviolet on hair , patients under treatment with this modality should be cautious to protect their hair during treatment .

###24572997
BACKGROUND	Kawasaki disease , the most common cause of acquired heart disease in developed countries , is a self-limited vasculitis that is treated with high doses of intravenous immunoglobulin .
BACKGROUND	Resistance to intravenous immunoglobulin in Kawasaki disease increases the risk of coronary artery aneurysms .
BACKGROUND	We assessed whether the addition of infliximab to standard therapy ( intravenous immunoglobulin and aspirin ) in acute Kawasaki disease reduces the rate of treatment resistance .
METHODS	We undertook a phase 3 , randomised , double-blind , placebo-controlled trial in two children 's hospitals in the USA to assess the addition of infliximab ( 5 mg per kg ) to standard therapy .
METHODS	Eligible participants were children aged 4 weeks-17 years who had a fever ( temperature 380C ) for 3-10 days and met American Heart Association criteria for Kawasaki disease .
METHODS	Participants were randomly allocated in 1:1 ratio to two treatment groups : infliximab 5 mg/kg at 1 mg/mL intravenously over 2 h or placebo ( normal saline 5 mL/kg , administered intravenously ) .
METHODS	Randomisation was based on a randomly permuted block design ( block sizes 2 and 4 ) , stratified by age , sex , and centre .
METHODS	Patients , treating physicians and staff , study team members , and echocardiographers were all masked to treament assignment .
METHODS	The primary outcome was the difference between the groups in treatment resistance defined as a temperature of 380C or higher at 36 h to 7 days after completion of the infusion of intravenous immunoglobulin .
METHODS	Analysis was by intention to treat .
METHODS	This trial is registered with ClinicalTrials.gov , NCT00760435 .
RESULTS	196 patients were enrolled and randomised : 98 to the infliximab group and 98 to placebo .
RESULTS	One patient in the placebo group was withdrawn from the study because of hypotension before receiving treatment .
RESULTS	Treatment resistance rate did not differ significantly ( 11 [ 112 % ] for infliximab and 11 [ 113 % ] for placebo ; p = 081 ) .
RESULTS	Compared with the placebo group , participants given infliximab had fewer days of fever ( median 1 day for infliximab vs 2 days for placebo ; p < 00001 ) .
RESULTS	At week 2 , infliximab-treated patients had greater mean reductions in erythrocyte sedimentation rate ( p = 0009 ) and a two-fold greater decrease in Z score of the left anterior descending artery ( p = 0045 ) than did those in the placebo group , but this difference was not significant at week 5 .
RESULTS	Participants in the infliximab group had a greater mean reduction in C-reactive protein concentration ( p = 00003 ) and in absolute neutrophil count ( p = 0024 ) at 24 h after treatment than did those given placebo , but by week 2 this difference was not significant .
RESULTS	At week 5 , none of the laboratory values differed significantly compared with baseline .
RESULTS	No significant differences were recorded between the two groups at any timepoint in proximal right coronary artery Z scores , age-adjusted haemoglobin values , duration of hospital stay , or any other laboratory markers of inflammation measured .
RESULTS	No reactions to intravenous immunoglobulin infusion occurred in patients treated with infliximab compared with 13 ( 134 % ) patients given placebo ( p < 00001 ) .
RESULTS	No serious adverse events were directly attributable to infliximab infusion .
CONCLUSIONS	The addition of infliximab to primary treatment in acute Kawasaki disease did not reduce treatment resistance .
CONCLUSIONS	However , it was safe and well tolerated and reduced fever duration , some markers of inflammation , left anterior descending coronary artery Z score , and intravenous immunoglobulin reaction rates .
BACKGROUND	US Food and Drug Administration , Robert Wood Johnson Foundation , and Janssen Biotech .

###26313301
OBJECTIVE	To analyze changes in refraction and associated biometric changes in atropine - and placebo-treated eyes in the Atropine for Treatment of Myopia study ( ATOM1 ) .
METHODS	A total of 400 myopic children , aged 6 to 12 years , were assigned randomly to receive 1 % atropine or a placebo agent in one eye daily for 2 years , after which drops were stopped and children monitored for another year .
METHODS	Cycloplegic autorefraction , A-scan biometry , and automated keratometry were performed at the initial visit , 2 weeks ( baseline ) , and at 4 , 8 , 12 , 16 , 20 , 24 , 30 , and 36 months .
RESULTS	A total of 313 children ( 78.3 % ) completed the study .
RESULTS	In placebo-treated eyes , there was myopic progression of -1.55 diopters ( D ) , between baseline and 36 months , associated with reductions in corneal curvature ( K ; -0.13 D ) and anterior chamber depth ( ACD ; -0.17 mm ) and increases in lens thickness ( LT ; 0.05 mm ) , vitreous chamber depth ( VCD ; 0.65 mm ) , and axial length ( AL ; 0.53 mm ) .
RESULTS	Multivariate analysis of change in spherical equivalent demonstrated that the hyperopic shift ( 0.20 D ) noted in atropine-treated eyes between baseline and 4 months , and the myopic rebound ( -0.74 D ) noted between 24 to 30 months when atropine was stopped , were associated with a reduction and increase in VCD and AL , respectively , after adjusting for age and sex .
RESULTS	Changes in K , ACD , and LT were less relevant .
RESULTS	Between 4 and 24 months , atropine-treated eyes demonstrated gradual myopic progression ( -0.40 D ) , accompanied by reduction in K ( -0.06 D ) and ACD ( -0.07 mm ) and increase in VCD ( 0.13 mm ) and AL ( 0.06 mm ) .
CONCLUSIONS	Atropine appeared to slow myopia progression mainly by reducing or slowing the growth in VCD , and thereby AL. ( ClinicalTrials.gov number , NCT00371124 . )

###24732289
BACKGROUND	Sutezolid ( PNU-100480 ) is a linezolid analog with superior bactericidal activity against Mycobacterium tuberculosis in the hollow fiber , whole blood and mouse models .
BACKGROUND	Like linezolid , it is unaffected by mutations conferring resistance to standard TB drugs .
BACKGROUND	This study of sutezolid is its first in tuberculosis patients .
METHODS	Sputum smear positive tuberculosis patients were randomly assigned to sutezolid 600 mg BID ( N = 25 ) or 1200 mg QD ( N = 25 ) , or standard 4-drug therapy ( N = 9 ) for the first 14 days of treatment .
METHODS	Effects on mycobacterial burden in sputum ( early bactericidal activity or EBA ) were monitored as colony counts on agar and time to positivity in automated liquid culture .
METHODS	Bactericidal activity was also measured in ex vivo whole blood cultures ( whole blood bactericidal activity or WBA ) inoculated with M. tuberculosis H37Rv .
RESULTS	All patients completed assigned treatments and began subsequent standard TB treatment according to protocol .
RESULTS	The 90 % confidence intervals ( CI ) for bactericidal activity in sputum over the 14 day interval excluded zero for all treatments and both monitoring methods , as did those for cumulative WBA .
RESULTS	There were no treatment-related serious adverse events , premature discontinuations , or dose reductions due to laboratory abnormalities .
RESULTS	There was no effect on the QT interval .
RESULTS	Seven sutezolid-treated patients ( 14 % ) had transient , asymptomatic ALT elevations to 17334 U/L on day 14 that subsequently normalized promptly ; none met Hy 's criteria for serious liver injury .
CONCLUSIONS	The mycobactericidal activity of sutezolid 600 mg BID or 1200 mg QD was readily detected in sputum and blood .
CONCLUSIONS	Both schedules were generally safe and well tolerated .
CONCLUSIONS	Further studies of sutezolid in tuberculosis treatment are warranted .
BACKGROUND	ClinicalTrials.gov NCT01225640 .

###25168752
BACKGROUND	Several planning studies have already proven the substantial dosimetric advantages of RapidArc ( RA ) over standard intensity-modulated radiotherapy .
BACKGROUND	We retrospectively compared RapidArc and standard sliding window IMRT ( swIMRT ) in locally advanced head and neck cancer , looking both at dosimetrics as well as toxicity and outcome .
METHODS	CT datasets of 78 patients treated with swIMRT and 79 patients treated with RA were included .
METHODS	To compare the resulting dose distributions , the dose-volume parameters were evaluated for the planning target volumes ( PTVs ) , clinical target volumes ( CTVs ) , and organs at risk ( OARs ) , and the number of MU were calculated .
METHODS	Acute toxicity was assessed by the Common Toxicity Criteria version 3.0 .
RESULTS	PTV coverage with the 95 % isodose was slightly better for RA .
RESULTS	Dose distribution has proven to be significantly more homogenous with RA and led to a reduction of 62 % in MU with better OAR sparing .
RESULTS	As for toxicity , more grade 3 mucositis and dysphagia was observed for swIMRT , though we observed more grade 3 dermatitis for RA .
CONCLUSIONS	In our retrospective analysis , RA had better target coverage and better sparing of the OAR .
CONCLUSIONS	Overall , the grade of acute toxicity was lower for RA than for swIMRT for the same types of tumor locations , except for the grade of dermatitis .

###24377663
BACKGROUND	Electrical muscle stimulation ( EMS ) is applied to critically ill patients in order to improve their muscle strength , thereby preventing hypotrophy and promoting functional recovery .
OBJECTIVE	To assess the effects of early EMS on the range of movement of the ankle joint , and on thigh and leg circumference in critically ill patients .
METHODS	This is a prospective randomized clinical trial comprising 11 patients undergoing mechanical ventilation .
METHODS	Before and after EMS the thigh and leg circumference in both lower limbs and the goniometry of the tibiotarsal joint were measured .
METHODS	The angle of 90 on the goniometer was taken as the standard neutral position ( NP ) , with the arm fixed on the lateral malleolus of the ankle joint .
METHODS	Other measurements , namely dorsiflexion and plantar flexion , referred to as mobile arm , were taken from the NP .
METHODS	These recordings were obtained following an active contraction of the patients ' muscles .
RESULTS	Compared with the electrostimulated limb , a difference in dorsiflexion of the control limb was observed ( 96.224.9 versus 119.914.1 ; p = 0.01 ) .
RESULTS	A girth of 10cm of the leg was found in limb reduction when compared to the electrostimulated one ( 24.73.1 versus 26.44.0 cm ; p = 0.03 ) .
CONCLUSIONS	EMS used at low current intensity and for a short duration failed to prevent muscle atrophy in critically ill patients .
CONCLUSIONS	However , we did find a significant improvement in active dorsiflexion of the ankle joint suggesting that it could help to prevent against stance plantar flexion in these patients .

###25488560
BACKGROUND	Despite numerous benefits of live donor kidney transplant ( LDKT ) , patient-level barriers often prevent African Americans from considering LDKT .
BACKGROUND	Educational interventions designed to address patient-level barriers may increase willingness among African American patients with end-stage renal disease to explore LDKT as a treatment option .
OBJECTIVE	To assess the effectiveness of a culturally sensitive educational intervention called Living ACTS ( About Choices in Transplantation and Sharing ) that was designed to address patient-level barriers to LDKT among African American patients with end-stage renal disease .
METHODS	Patients were randomized to intervention ( n = 136 ) or control ( n = 132 ) groups .
METHODS	They completed baseline measures and then viewed either the Living ACTS or control video .
METHODS	Both groups then completed an immediate follow-up measure and a 6-month assessment administered via telephone .
METHODS	Self-reported knowledge about LDKT , willingness to talk to the patient 's family about LDKT , and perceived benefits of LDKT were measured at 3 time points .
RESULTS	At 6-month follow-up , intervention participants demonstrated a significantly greater increase in knowledge of LDKT than control participants ( F2 ,229 = 3.08 , P = .05 ) .
RESULTS	Intervention participants expressed greater willingness to talk to patients ' families about LDKT than did control participants from baseline through 6-month follow-up ( F1 ,230 = 7.11 , P = .008 ) .
RESULTS	Finally , at immediate follow-up , intervention participants reported greater endorsement of the benefits of LDKT than did control participants ( F2 ,223 = 14.27 , P < .001 ) ; however , this effect had disappeared by the 6-month follow-up .
CONCLUSIONS	Living ACTS is effective at increasing and maintaining knowledge about LDKT among African American patients with end-stage renal disease who are considering transplant .

###25788517
BACKGROUND	Discharge anticoagulation counseling is important for ensuring patient comprehension and optimizing clinical outcomes .
BACKGROUND	As pharmacy resources become increasingly limited , the impact of informational videos on the counseling process becomes more relevant .
OBJECTIVE	To evaluate differences in pharmacist time spent counseling and patient comprehension ( measured by the Oral Anticoagulation Knowledge [ OAK ] test ) between informational videos and traditional face-to-face ( oral ) counseling .
METHODS	This prospective , open , parallel-group study at an academic medical center randomized 40 individuals-17 warfarin-nave ( `` New Start '' ) and 23 with prior warfarin use ( `` Restart '' ) - to receive warfarin discharge education by video or face-to-face counseling .
METHODS	`` Teach-back '' questions were used in both groups .
RESULTS	Although overall pharmacist time was reduced in the video counseling group ( P < 0.001 ) , an interaction between prior warfarin use and counseling method ( P = 0.012 ) suggests the difference between counseling methods was smaller in New Start participants .
RESULTS	Following adjustment , mean total time was reduced 8.71 ( 95 % CI = 5.15-12 .26 ) minutes ( adjusted P < 0.001 ) in Restart participants and 2.31 ( -2.19 to 6.81 ) minutes ( adjusted P = 0.472 ) in New Start participants receiving video counseling .
RESULTS	Postcounseling OAK test scores did not differ .
RESULTS	Age , gender , socioeconomic status , and years of education were not predictive of total time or OAK test score .
CONCLUSIONS	Use of informational videos coupled with teach-back questions significantly reduced pharmacist time spent on anticoagulation counseling without compromising short-term patient comprehension , primarily in patients with prior warfarin use .
CONCLUSIONS	Study results demonstrate that video technology provides an efficient method of anticoagulation counseling while achieving similar comprehension .

###24952869
BACKGROUND	The postpericardiotomy syndrome ( PPS ) is a common complication following cardiac surgery .
BACKGROUND	The pathophysiology remains unclear , although evidence exists that surgical trauma and the use of cardiopulmonary bypass provoke an immune response leading to PPS .
BACKGROUND	We hypothesized that an intraoperative dose of dexamethasone decreases the risk of PPS , by reducing this inflammatory response .
METHODS	We performed a subanalysis of the DECS study , which is a multicenter , double-blind , placebo-controlled , randomized trial of 4,494 patients undergoing cardiac surgery with use of cardiopulmonary bypass .
METHODS	The aim of the DECS study was to investigate whether a single intraoperative dose of 1 mg/kg dexamethasone reduced the incidence of a composite of death , myocardial infarction , stroke , renal failure , or respiratory failure , within 30 days of randomization .
METHODS	In this substudy , we retrospectively analyzed the occurrence of PPS in 822 patients who were included in the DECS trial and underwent valvular surgery .
METHODS	Postpericardiotomy syndrome was diagnosed if 2 of 5 listed symptoms were present : unexplained fever , pleuritic chest pain , pericardial or pleural rub , new or worsening pericardial or pleural effusion .
METHODS	All medical charts , x-rays , and echocardiograms were reviewed .
METHODS	Secondary end point was the occurrence of complicated PPS , defined as PPS with need for evacuation of pleural effusion , pericardiocentesis , and tamponade requiring intervention or hospital readmission for PPS .
METHODS	This is a blinded , single-center , post hoc analysis .
RESULTS	Postpericardiotomy syndrome occurred in 119 patients ( 14.5 % ) .
RESULTS	The incidence of PPS after dexamethasone compared with placebo was 13.5 % vs 15.5 % ( relative risk 0.88 , 95 % CI 0.63-1 .22 ) .
RESULTS	For complicated PPS , the incidence was 3.8 % versus 3.2 % ( relative risk 1.17 , 95 % CI 0.57-2 .41 , P = .66 ) , respectively .
CONCLUSIONS	In patients undergoing valvular cardiac surgery , high-dose dexamethasone treatment had no protective effect on the occurrence of PPS or complicated PPS .

###25689244
OBJECTIVE	To assess the effect of two selective serotonin reuptake inhibitors ( SSRIs ) , fluvoxamine and citalopram , that markedly differ in their level of cytochrome P450 ( CYP ) 2C19 inhibition , on the laboratory response to clopidogrel , a prodrug requiring metabolism by the CYP system , and especially CYP2C19 , to produce its active form .
METHODS	Randomized , double-blind , crossover trial .
METHODS	Clinical research unit of an academic medical center .
METHODS	Fifteen healthy male volunteers .
METHODS	All subjects received clopidogrel as a 300-mg loading dose on day 1 , followed by 75mg/day on days 2 and 3 .
METHODS	Platelet function was tested at baseline and then after clopidogrel treatment on day 3 .
METHODS	After a washout period of 2weeks , subjects were randomly assigned in a double-blind manner to receive either citalopram 20mg/day or fluvoxamine 100mg/day for 7days .
METHODS	On day 5 , platelet function was tested while receiving the SSRI treatment alone ; then , a 300-mg clopidogrel loading dose was administered , followed by clopidogrel 75mg/day on days 6 and 7 .
METHODS	Platelet function was then reassessed on day 7 while receiving the combination of the SSRI and clopidogrel .
METHODS	The treatment protocol was then repeated after a washout period of 2weeks in all subjects with the other SSRI .
RESULTS	The antiplatelet effects of fluvoxamine and citalopram and their interactions with clopidogrel were assessed .
RESULTS	The response to these three drugs was assessed by light transmittance aggregometry and vasodilator-stimulated phosphoprotein phosphorylation , reporting P2Y12 receptor reactivity .
RESULTS	Both fluvoxamine and citalopram tended to reduce adenosine diphosphate-induced aggregation : 80.83.4 % at baseline , 67.36.3 % while receiving citalopram , and 65.86.4 % while receiving fluvoxamine .
RESULTS	All subjects had a good laboratory response to clopidogrel , with a mean aggregation of 23.53.2 % and a mean platelet reactivity index of 47.73.9 % ( p < 0.001 compared with baseline for both methods ) .
RESULTS	Laboratory response to clopidogrel was significantly attenuated in the presence of fluvoxamine compared with the response in the presence of citalopram as tested both by aggregometry ( 32.34.2 % vs 23.43 % , p = 0.04 ) and by vasodilator-stimulated phosphoprotein phosphorylation ( 52.75.1 % vs 35.94.2 % , p = 0.02 ) .
CONCLUSIONS	Fluvoxamine attenuated the laboratory response to clopidogrel , possibly through inhibition of CYP2C19 , whereas citalopram did not affect this response .
CONCLUSIONS	These potential drug interactions should be taken into consideration in the selection of the appropriate antidepressant agent for patients who are treated with clopidogrel .

###26081580
BACKGROUND	Millions of children worldwide suffer from posttraumatic stress disorder ( PTSD ) symptoms and other mental health problems due to repeated exposure to war or organized violence .
BACKGROUND	Forms of cognitive-behavioral therapy ( CBT ) are the most commonly used treatment for PTSD and appear to be effective for children as well , but little is known about the mechanisms of change through which they achieve their effectiveness .
BACKGROUND	Here we present the study protocol of a randomized controlled trial ( RCT ) studying the effectiveness and mechanisms of change of Narrative Exposure Therapy ( NET ) , a CBT-based , manualized , short-term intervention for PTSD symptoms resulting from repeated traumatization , in immigrant children traumatized by war .
METHODS	We are conducting a multicentre , pragmatic RCT in a usual care setting .
METHODS	Up to 80 9-17-year-old immigrant children who have experienced war and suffer from PTSD symptoms will be randomized into intervention ( NET ) and control ( treatment as usual , TAU ) groups of equal sizes .
METHODS	The effectiveness of NET treatment will be compared to both a waiting list and the parallel TAU positive control group , on the primary outcomes of PTSD and depressive symptoms , psychological distress , resilience , and level of cognitive performance .
METHODS	The effects of the intervention on traumatic memories and posttraumatic cognitions will be studied as potential mechanisms of change mediating overall treatment effectiveness .
METHODS	The possible moderating effects of peritraumatic dissociation , level of cognitive performance , and gender on treatment effectiveness will also be considered .
METHODS	We hypothesize that NET will be more effective than a waitlist condition or TAU in reducing PTSD and other symptoms and improving resilience , and that these effects will be mediated by changes in traumatic memories and posttraumatic cognitions .
CONCLUSIONS	The results of this trial will provide evidence for the effectiveness of NET in treating trauma-related symptoms in immigrant children affected by war .
CONCLUSIONS	The trial will also generate insights into the complex relationships between PTSD , memory functions , posttraumatic cognitions and cognitive performance in children , and help guide the future development and implementation of therapeutic interventions for PTSD in children .
BACKGROUND	ClinicalTrials.gov NCT02425280 .
BACKGROUND	Registered 15 April 2015 .

###25015354
OBJECTIVE	Docosahexaenoic acid ( DHA ) continues to be evaluated and recommended as treatment and prophylaxis for various diseases .
OBJECTIVE	We recently assessed efficacy of high-dose DHA supplementation to slow vision loss in patients with X-linked retinitis pigmentosa ( XLRP ) in a randomized clinical trial .
OBJECTIVE	Because DHA is a highly unsaturated fatty acid , it could serve as a target for free-radical induced oxidation , resulting in increased oxidative stress .
OBJECTIVE	Biosafety was monitored during the 4-year trial to determine whether DHA supplementation was associated with identifiable risks .
METHODS	Males ( n = 78 ; 7-31 years ) meeting entry criteria were enrolled .
METHODS	The modified intent-to-treat cohort ( DHA = 33 ; placebo = 27 ) adhered to the protocol 1 year .
METHODS	Participants were randomized to an oral dose of 30 mg/kg/d DHA or placebo plus a daily multivitamin .
METHODS	Comprehensive metabolic analyses were assessed for group differences .
METHODS	Treatment-emergent adverse events including blood chemistry metabolites were recorded .
RESULTS	By year 4 , supplementation elevated plasma and red blood cell-DHA 4.4 - and 3.6-fold , respectively , compared with the placebo group ( P < 0.00001 ) .
RESULTS	Over the trial duration , no significant differences between DHA and placebo groups were found for vitamin A , vitamin E , platelet aggregation , antioxidant activity , lipoprotein cholesterol , or oxidized LDL levels ( all P > 0.14 ) .
RESULTS	Adverse events were transient and not considered severe ( e.g. , gastrointestinal [ GI ] irritability , blood chemistry alterations ) .
RESULTS	One participant was unable to tolerate persistent GI discomfort .
CONCLUSIONS	Long-term , high-dose DHA supplementation to patients with XLRP was associated with limited safety risks in this 4-year trial .
CONCLUSIONS	Nevertheless , GI symptoms should be monitored in all patients taking high dose DHA especially those with personal or family history of GI disturbances .
CONCLUSIONS	( ClinicalTrials.gov number , NCT00100230 . )

###25515179
BACKGROUND	A lack of physical activity and overconsumption of energy dense food is associated with overweight and obesity .
BACKGROUND	The neighbourhood environment may stimulate or hinder the development and/or maintenance of a healthy lifestyle .
BACKGROUND	To improve research on the obesogenicity of neighbourhood environments , reliable , valid and convenient assessment methods of potential obesogenic characteristics of neighbourhood environments are needed .
BACKGROUND	This study examines the reliability and validity of the SPOTLIGHT-Virtual Audit Tool ( S-VAT ) , which uses remote sensing techniques ( Street View feature in Google Earth ) for desk-based assessment of environmental obesogenicity .
METHODS	A total of 128 street segments in four Dutch urban neighbourhoods - heterogeneous in socio-economic status and residential density - were assessed using the S-VAT .
METHODS	Environmental characteristics were categorised as walking related items , cycling related items , public transport , aesthetics , land use-mix , grocery stores , food outlets and physical activity facilities .
METHODS	To assess concordance of inter - and intra-observer reliability of the Street View feature in Google Earth , and validity scores with real life audits , percentage agreement and Cohen 's Kappa ( k ) were calculated .
RESULTS	Intra-observer reliability was high and ranged from 91.7 % agreement ( k = 0.654 ) to 100 % agreement ( k = 1.000 ) with an overall agreement of 96.4 % ( k = 0.848 ) .
RESULTS	Inter-observer reliability results ranged from substantial agreement 78.6 % ( k = 0.440 ) to high agreement , 99.2 % ( k = 0.579 ) , with an overall agreement of 91.5 % ( k = 0.595 ) .
RESULTS	Criterion validity was substantial to high for most of the categories ranging from 87.3 % agreement ( k = 0.539 ) to 99.9 % agreement ( k = 0.887 ) with an overall score of 95.6 % agreement ( k = 0.747 ) .
CONCLUSIONS	These study results suggest that the S-VAT is a highly reliable and valid remote sensing tool to assess potential obesogenic environmental characteristics .

###25525981
OBJECTIVE	To describe the prognostic value of three novel biomarkers for acute adverse kidney events compared with routine biological markers .
METHODS	We used high-end MS to quantify biomarkers predictive of acute kidney injury ( AKI ) and major adverse kidney events ( MAKE ) in 100 adult patients after open heart surgery ( n = 100 ) .
RESULTS	Early postoperatively measured LG3 ( a C-terminal fragment of perlecan ) , LTBP2 ( latent transforming growth factor binding protein-2 ) , Cathepsin L as well as two other renal biomarkers ( NGAL , Cystatin C ) had greater predictive value for AKI ( n = 23 ) and MAKE ( n = 24 ) compared with creatinine , urea and urine output .
CONCLUSIONS	LG3 , LTBP2 and Cathepsin L deserve further exploration as biomarkers for the early identification of patients at risk of MAKE .

###25077364
BACKGROUND	To investigate the effects of exercise preconditioning on oxidative injury in the intestinal tissue of rats .
METHODS	Sixty male Wistar rats were randomly divided into six groups as sham ( n = 10 ) , ischemia-reperfusion ( n = 10 ) , exercise ( n = 10 ) , exercise plus ischemia-reperfusion ( n = 10 ) , ischemic preconditioning ( n = 10 ) , and ischemic preconditioning plus ischemia-reperfusion groups ( n = 10 ) .
METHODS	Tissue levels of malondialdehyde and activities of myeloperoxidase and superoxide dismutase , and serum levels of tumor necrosis factor-alpha and interleukin-6 were measured .
METHODS	Intestinal tissue histopathology was also evaluated by light microscopy .
RESULTS	Tumor necrosis factor-alpha concentrations significantly decreased in the exercise group compared to the sham group ( p < 0.05 ) .
RESULTS	Myeloperoxidase activity significantly increased and superoxide dismutase activity significantly decreased in ischemia-reperfusion group compared to the sham group ( p < 0.05 ) .
RESULTS	Superoxide dismutase activity in the ischemic preconditioning and ischemic preconditioning plus ischemia-reperfusion groups were significantly higher compared to the ischemia-reperfusion and exercise groups ( p < 0.05 ) .
RESULTS	Histopathologically , intestinal injury significantly attenuated in the exercise plus ischemia-reperfusion group compared to the ischemia-reperfusion group .
CONCLUSIONS	The results of the present study indicate that exercise training seems to have a protective role against intestinal ischemia-reperfusion injury ( Tab .
CONCLUSIONS	3 , Fig. 1 , Ref .
CONCLUSIONS	35 ) .

###24360050
OBJECTIVE	To observe the sedative and analgesic effects of dexmedetomidine ( Dex ) and its influence on respiration and blood pressure , evaluate electrophysiological monitoring and explore the optimal dose of Dex for brain nuclei lesion in Parkinson 's disease ( PD ) patients .
METHODS	Approved by hospital ethics committee , 60 PD patients undergoing brain nuclei lesion ablation were randomly allocated into 3 groups ( n = 20 each ) .
METHODS	No sedative anesthetic was used in group A ; In group B , Dex 0.3 g/kg intravenously for initial bolus ( duration 15 min ) and then 0.3 gkg ( -1 ) h ( -1 ) continuous infusion ; In group C , Dex 0.5 g/kg intravenously ( duration 15 min ) for initial load and then 0.3 gkg ( -1 ) h ( -1 ) continuous infusion .
METHODS	The parameters of mean arterial pressure ( MAP ) , heart rate ( HR ) , pressure of end-tidal carbon dioxide ( P ETCO2 ) , respiratory rate , blood oxygen saturation ( SpO2 ) , observer 's assessment of alertness/sedation ( OAA/S ) and verbal rating score ( VRS ) were recorded at 0 min ( baseline ) , 5 min ( T1 ) , 10 min ( T2 ) , 15 min ( T3 ) , 20 min ( T4 ) , 30 min ( T5 ) and 60 min ( T6 ) after the dosing of Dex .
RESULTS	HR and respiratory rate decreased in groups B and C compared with baseline .
RESULTS	In group C , P ETCO2 was much higher , compared with baseline ( P < 0.05 ) .
RESULTS	Blood pressures of three groups were well-controlled .
RESULTS	The incidence of pain ( VRS 1 ) in group A was significantly higher than those of groups B and C ( P < 0.05 ) .
RESULTS	And the incidence of sedation ( OAA/S > 1 ) in group C was much higher than those of groups A and B.
RESULTS	The electrophysiological signal of two patients in group C was severely affected .
CONCLUSIONS	At an initial intravenous dose of Dex 0.3 g/kg and a maintenance dose of 0.3 g kg ( -1 ) h ( -1 ) , electrophysiological monitoring for surgery is not affected in PD patients undergoing brain nuclei lesion ablation .
CONCLUSIONS	With a minimal interference of breath , Dex has not only well-controlled effects on sedation , analgesia and blood pressure , but also makes patients comfortable .

###24717389
OBJECTIVE	To characterize subgroups of subjects with schizophrenia from the Ziprasidone Observational Study of Cardiac Outcomes ( ZODIAC ) trial who either completed or attempted suicide and those who did not .
METHODS	The ZODIAC , conducted between February 2002 and March 2007 , was an open-label , randomized , large simple trial of patients with schizophrenia ( N = 18,154 ) followed up for 1 year by unblinded investigators providing usual care in 18 countries ; the primary outcome measure was nonsuicide mortality .
METHODS	Every report on a completed or attempted suicide was independently adjudicated using a predefined algorithm .
METHODS	Primary analysis for the current report examined the association between completed or attempted suicides and the baseline variables using descriptive statistics and multivariate logistic regression models .
METHODS	Usage of `` hard '' or `` soft '' methods for attempted or completed suicide and distribution of suicide-related events by geographical region were also summarized .
RESULTS	Overall incidences of subjects who either completed ( 35/18 ,154 ) or attempted ( 108/18 ,154 ) suicide were low , as were rates per person-time on assigned treatment analysis ( 0.24 for completed and 0.74 for attempted suicides per 100 person-years of exposure ) .
RESULTS	The highest suicide-related mortality was seen among subjects recently diagnosed with schizophrenia .
RESULTS	Among all potential baseline risk factors for completed suicide examined , the variables most associated with completed suicide were history of suicide attempts ( OR = 2.6 ; 95 % CI , 1.33-5 .12 ) and usage of antidepressant medication ( OR = 3.5 ; 95 % CI , 0.84-14 .85 ) .
RESULTS	History of > 5 hospitalizations in the past ( OR = 2.1 ; 95 % CI , 1.35-3 .31 ) and history of suicide attempts ( OR = 5.0 ; 95 % CI , 3.21-7 .76 ) were the variables most associated with attempted suicide among potential baseline risk factors for suicide attempts .
CONCLUSIONS	Our results , obtained in a large prospective randomized study , confirm current clinical understanding regarding completed or attempted suicide in schizophrenia and the associated risk factors .
BACKGROUND	ClinicalTrials.gov identifier : NCT00418171 .

###24751462
OBJECTIVE	To evaluate the efficacy of a short-term intravenous infusion of levosimendan in patients with heart failure due to acute myocardial infarction ( AMI ) .
METHODS	This was a randomized , single-center , single-blind study that included 160 patients .
METHODS	Patients were randomly divided into 2 groups : 1 received levosimendan ( n = 80 ) and the other received placebo ( n = 80 ) .
METHODS	The study included multiple primary end points ( death , myocardial ischemia or worsening heart at the 6 month follow-up ) and used a composite outcome .
RESULTS	The primary end point rate in the levosimendan group was lower than that in placebo group ( 43.7 vs. 62.5 % , HR 0.636 , 95 % CI 0.413-0 .981 , p = 0.041 ) .
RESULTS	Moreover , the mortality rate at 6 months was similar between the 2 groups ( 17.5 vs. 22.5 % , HR 0.786 , 95 % CI 0.382-1 .543 , p = 0.458 ) .
RESULTS	There was a higher incidence of myocardial ischemia in the levosimendan group at 14 days than in the placebo group ( 11.2 vs. 7.5 % , HR 1.510 , p = 0.435 ) , but between 15 and 180 days , it was significantly lower in the levosimendan group than in the placebo group ( 3.8 vs. 13.8 % , HR 0.261 , p = 0.036 ) .
CONCLUSIONS	Short-term intravenous infusion of levosimendan appears to be more effective than placebo for treating patients with heart failure complicated by AMI .

###24467669
OBJECTIVE	To determine if supervised exercise minimises treatment toxicity in patients with prostate cancer initiating androgen-deprivation therapy ( ADT ) .
OBJECTIVE	This is the first study to date that has investigated the potential role of exercise in preventing ADT toxicity rather than recovering from established toxicities .
METHODS	Sixty-three men scheduled to receive ADT were randomly assigned to a 3-month supervised exercise programme involving aerobic and resistance exercise sessions commenced within 10 days of their first ADT injection ( 32 men ) or usual care ( 31 men ) .
METHODS	The primary outcome was body composition ( lean and fat mass ) .
METHODS	Other study outcomes included bone mineral density , physical function , blood biomarkers of chronic disease risk and bone turnover , general and prostate cancer-specific quality of life , fatigue and psychological distress .
METHODS	Outcomes were compared between groups using analysis of covariance adjusted for baseline values .
RESULTS	Compared to usual care , a 3-month exercise programme preserved appendicular lean mass ( P = 0.019 ) and prevented gains in whole body fat mass , trunk fat mass and percentage fat with group differences of -1.4 kg ( P = 0.001 ) , -0.9 kg ( P = 0.008 ) and -1.3 % ( P < 0.001 ) , respectively .
RESULTS	Significant between-group differences were also seen favouring the exercise group for cardiovascular fitness ( peak oxygen consumption 1.1 mL/kg/min , P = 0.004 ) , muscular strength ( 4.0-25 .9 kg , P 0.026 ) , lower body function ( -1.1 s , P < 0.001 ) , total cholesterol : high-density lipoprotein-cholesterol ratio ( -0.52 , P = 0.028 ) , sexual function ( 15.2 , P = 0.028 ) , fatigue ( 3.1 , P = 0.042 ) , psychological distress ( -2.2 , P = 0.045 ) , social functioning ( 3.8 , P = 0.015 ) and mental health ( 3.6-3 .8 , P 0.022 ) .
RESULTS	There were no significant group differences for any other outcomes .
CONCLUSIONS	Commencing a supervised exercise programme involving aerobic and resistance exercise when initiating ADT significantly reduced treatment toxicity , while improving social functioning and mental health .
CONCLUSIONS	Concurrent prescription of supervised exercise when initiating ADT is therefore advised to minimise morbidity associated with severe hypogonadism .

###24472342
BACKGROUND	Endoscopic mucosal resection ( EMR ) is simple and quick and has low complication rates .
BACKGROUND	However , the disadvantage of local recurrence or remnant rate limits the use of this technique .
BACKGROUND	We aimed to analyse the outcomes of conventional EMR and EMR with circumferential incision ( CIEMR ) , a simplified modification of EMR , in the endoscopic treatment of rectal carcinoid tumours .
METHODS	A total of 59 consecutive patients with rectal carcinoid tumours without regional lymph node enlargement confirmed by endoscopic ultrasonography were included in the study .
METHODS	These patients underwent endoscopic treatment from January 2009 to September 2011 and were randomly designated into CIEMR ( n = 31 ) or EMR group ( n = 28 ) .
METHODS	En bloc resection rate , pathological complete resection rate , procedure time , complications and follow-up outcomes were analysed .
RESULTS	The en bloc resection rate was not significantly different between the CIEMR and EMR groups ( 100 % versus 96.55 % , P > 0.05 ) .
RESULTS	The pathological complete resection rate was higher in the CIEMR group than in the EMR group ( 96.7 % versus 82.14 % , P < 0.05 ) .
RESULTS	The overall complication rate , delayed bleeding and procedure time were not significantly different between the two groups .
RESULTS	No recurrence was observed in either the EMR or CIEMR group .
CONCLUSIONS	CIEMR optimises the procedure of EMR and simplifies the technique of endoscopic submucosal dissection ; thus , it has a better histologically complete resection rate and more acceptable complication rate than EMR .
CONCLUSIONS	Thus , CIEMR may be preferable to conventional EMR for resection of rectal carcinoid tumours less than 15 mm .

###25757358
BACKGROUND	One-quarter of the world 's population will suffer from depression symptoms at some point in their lives .
BACKGROUND	Mental health services in developed countries are overburdened .
BACKGROUND	Therefore , cost-effective interventions that provide mental health care solutions such as Web-based psychotherapy programs have been proposed .
OBJECTIVE	The intent of the study was to identify expectations regarding Web-based psychotherapy for the treatment of depression in primary care among patients and health professionals that might facilitate or hinder its effects .
METHODS	The expectations of untreated patients and health professionals were examined by means of interviews and focus groups .
METHODS	There were 43 participants ( 20 patients with mild and moderate levels of depression , 11 primary care physicians , and 12 managers ; 22 of them for interviews and 21 for groups ) .
METHODS	A thematic content analysis from the grounded theory for interviews , and an analysis of the discursive positions of participants based on the sociological model for groups were performed .
METHODS	Interpretations were achieved by agreement between three independent analysts .
RESULTS	All participants showed a good general acceptance of Web-based psychotherapy , appreciating possible advantages and improvements .
RESULTS	Patients , physicians , and managers shared the same conceptualization of their expectations , although highlighting different aspects .
RESULTS	Patients focused on the need for individualized and personalized interaction , while professionals highlighted the need for the standardization of the program .
RESULTS	Physicians were concerned with extra workload , while managers were worried about optimizing cost-effectiveness .
CONCLUSIONS	Expectations of the different participants can conflict with each other .
CONCLUSIONS	Finding a balanced position among them is needed if we are to harmoniously implement effective Web-based interventions for depression in routine clinical practice .

###24440473
BACKGROUND	EORTC trial 22921 examined the addition of preoperative or postoperative chemotherapy to preoperative radiotherapy in patients with rectal cancer .
BACKGROUND	After a median follow-up of 5 years , chemotherapy-irrespective of timing-significantly improved local control .
BACKGROUND	Adjuvant chemotherapy did not improve survival , but the Kaplan-Meier curves diverged , suggesting possible delayed benefit .
BACKGROUND	Here , we report the updated long-term results .
METHODS	We randomly assigned patients with clinical stage T3 or T4 resectable rectal cancer to receive preoperative radiotherapy with or without concomitant chemotherapy before surgery followed by either adjuvant chemotherapy or surveillance .
METHODS	Randomisation was done using minimisation with factors of institution , sex , T stage , and distance from the tumour to the anal verge .
METHODS	Study coordinators , clinicians , and patients were aware of assignment .
METHODS	Radiotherapy consisted of 45 Gy to the posterior pelvis in 25 fractions of 18 Gy over 5 weeks .
METHODS	Each course of chemotherapy consisted of fluorouracil ( 350 mg/m ( 2 ) per day intravenous bolus ) and folinic acid ( leucovorin ; 20 mg/m ( 2 ) per day intravenous bolus ) .
METHODS	For preoperative chemotherapy , two courses were given ( during weeks 1 and 5 of radiotherapy ) .
METHODS	Adjuvant chemotherapy was given in four cycles , every 3 weeks .
METHODS	The primary endpoint was overall survival .
METHODS	This analysis was done by intention to treat .
METHODS	The trial is registered with ClinicalTrials.gov , number NCT00002523 .
RESULTS	1011 patients were randomly assigned to treatment between April , 1993 , and March , 2003 ( 252 to preoperative radiotherapy and 253 to each of the other three groups ) .
RESULTS	After a median follow-up of 104 years ( IQR 78-131 ) , 10-year overall survival was 494 % ( 95 % CI 446-541 ) for the preoperative radiotherapy group and 507 % ( 459-552 ) for the preoperative radiotherapy and chemotherapy group ( HR 099 , 95 % CI 083-118 ; p = 091 ) .
RESULTS	10-year overall survival was 518 % ( 95 % CI 470-564 ) for the adjuvant chemotherapy group and 484 % ( 436-530 ) for the surveillance group ( HR 091 , 95 % CI 077-109 , p = 032 ) .
RESULTS	10-year disease-free survival was 442 % ( 95 % CI 395-488 ) for the preoperative radiotherapy group and 464 % ( 417-509 ) for the preoperative radiotherapy and chemotherapy group ( HR 093 , 95 % CI 079-110 ; p = 038 ) .
RESULTS	10-year disease-free survival was 470 % ( 95 % CI 422-516 ) for the adjuvant chemotherapy group and 437 % ( 391-482 ) for the surveillance group ( HR 091 , 95 % CI 077-108 , p = 029 ) .
RESULTS	At 10 years , cumulative incidence of local relapse was 224 % ( 95 % CI 171-276 ) with radiotherapy alone , 118 % ( 78-158 ) with neoadjuvant radiotherapy and chemotherapy , 145 % ( 101-189 ) with radiotherapy and adjuvant chemotherapy and 117 % ( 77-156 ) with both adjuvant and neoadjuvant chemotherapy ( p = 00017 ) .
RESULTS	There was no difference in cumulative incidence of distant metastases ( p = 052 ) .
RESULTS	The frequency of long-term side-effects did not differ between the four groups ( p = 022 ) .
CONCLUSIONS	Adjuvant fluorouracil-based chemotherapy after preoperative radiotherapy ( with or without chemotherapy ) does not affect disease-free survival or overall survival .
CONCLUSIONS	Our trial does not support the current practice of adjuvant chemotherapy after preoperative radiotherapy with or without chemotherapy .
CONCLUSIONS	New treatment strategies incorporating neoadjuvant chemotherapy are required .
BACKGROUND	EORTC , US National Cancer Institute , Programme Hospitalier de Recherche Clinique , Ligue contre le Cancer Comit du Doubs .

###26132315
BACKGROUND	A variety of techniques exist for the treatment of patients with great saphenous vein ( GSV ) varicosities .
BACKGROUND	Few data exist on the long-term outcomes of these interventions .
METHODS	Patients undergoing conventional surgery , endovenous laser ablation ( EVLA ) and ultrasound-guided foam sclerotherapy ( UGFS ) for GSV varicose veins were followed up for 5 years .
METHODS	Primary outcome was obliteration or absence of the treated GSV segment ; secondary outcomes were absence of GSV reflux , and change in Chronic Venous Insufficiency quality-of-life Questionnaire ( CIVIQ ) and EuroQol - 5D ( EQ-5D ) scores .
RESULTS	A total of 224 legs were included ( 69 conventional surgery , 78 EVLA , 77 UGFS ) , 193 ( 86.2 per cent ) of which were evaluated at final follow-up .
RESULTS	At 5 years , Kaplan-Meier estimates of obliteration or absence of the GSV were 85 ( 95 per cent c.i. 75 to 92 ) , 77 ( 66 to 86 ) and 23 ( 14 to 33 ) per cent in the conventional surgery , EVLA and UGFS groups respectively .
RESULTS	Absence of above-knee GSV reflux was found in 85 ( 73 to 92 ) , 82 ( 72 to 90 ) and 41 ( 30 to 53 ) per cent respectively .
RESULTS	CIVIQ scores deteriorated over time in patients in the UGFS group ( 0.98 increase per year , 95 per cent c.i. 0.16 to 1.79 ) , and were significantly worse than those in the EVLA group ( -0.44 decrease per year , 95 per cent c.i. -1.22 to 0.35 ) ( P = 0.013 ) .
RESULTS	CIVIQ scores for the conventional surgery group did not differ from those in the EVLA and UGFS groups ( 0.44 increase per year , 95 per cent c.i. -0.41 to 1.29 ) .
RESULTS	EQ-5D scores improved equally in all groups .
CONCLUSIONS	EVLA and conventional surgery were more effective than UGFS in obliterating the GSV 5 years after intervention .
CONCLUSIONS	UGFS was associated with substantial rates of GSV reflux and inferior CIVIQ scores compared with EVLA and conventional surgery .
BACKGROUND	NCT00529672 ( http://www.clinicaltrials.gov ) .

###24531792
OBJECTIVE	Chemotherapy-induced peripheral neuropathy ( CIPN ) occurs in as high as 70 % of patients receiving certain types of chemotherapy agents .
OBJECTIVE	The FDA has yet to approve a therapy for CIPN .
OBJECTIVE	The aim of this multicenter , phase III , randomized , double-blind , placebo-controlled trial was to investigate the efficacy of 2 % ketamine plus 4 % amitriptyline ( KA ) cream for reducing CIPN .
METHODS	Cancer survivors who completed chemotherapy at least 1 month prior and had CIPN ( > 4 out of 10 ) were enrolled ( N = 462 ) .
METHODS	CIPN was assessed using average scores from a 7-day daily diary that asks patients to rate the average `` pain , numbness , or tingling in [ their ] hands and feet over the past 24 h '' on an 11-point numeric rating scale at baseline and 6 weeks post intervention .
METHODS	ANCOVA was used to measure differences in 6-week CIPN with effects including baseline CIPN , KA treatment arm , and previous taxane therapy ( Y/N ) .
RESULTS	The KA treatment showed no effect on 6-week CIPN scores ( adjusted mean difference = -0.17 , p = 0.363 ) .
CONCLUSIONS	This study suggests that KA cream does not decrease CIPN symptoms in cancer survivors .

###24434526
OBJECTIVE	This study investigated the long-term safety of rivastigmine ( 12 mg/d capsules , 9.5 mg/24 h patch ) and effects on motor symptoms in patients with mild-to-moderately severe Parkinson disease dementia .
METHODS	This was a 76-week , prospective , open-label , randomized study in patients aged 50 to 85 years .
METHODS	Primary outcomes included incidence of , and discontinuation due to , predefined adverse events ( AEs ) potentially arising from worsening of Parkinson disease motor symptoms with capsules .
METHODS	Secondary outcomes included frequency of AEs/serious AEs .
METHODS	Efficacy outcomes included Alzheimer 's Disease Cooperative Study-Activities of Daily Living ( ADCS-ADL ) , Neuropsychiatric Inventory ( NPI-10 ) , and Mattis Dementia Rating Scale ( MDRS ) .
RESULTS	Five hundred eighty-three patients were randomized to rivastigmine capsules ( n = 295 ) or patch ( n = 288 ) .
RESULTS	Incidence of predefined AEs was 36.1 % for capsules , 31.9 % for patch ; discontinuation due to worsening of motor symptoms was 4.4 % and 2.4 % , respectively .
RESULTS	Most common AEs were nausea ( capsules , 40.5 % ; patch , 8.3 % ) , tremor ( 24.5 % ; 9.7 % ) , fall ( 17.0 % ; 20.1 % ) , vomiting ( 15.3 % ; 2.8 % ) , and application site erythema ( 0 % ; 13.9 % ) .
RESULTS	Significant efficacy in favor of capsules was observed at weeks 24 to 76 on MDRS ; 24 and 76 on NPI-10 ; weeks 52 and 76 on ADCS-ADL .
RESULTS	In patients with Mini-Mental State Examination ( MMSE ) greater than 21 , no differences in efficacy on MDRS and ADCS-ADL were observed at any time point ; significant differences in favor of capsules were maintained in patients with MMSE less than or equal to 21 .
CONCLUSIONS	This study supports the long-term safety of rivastigmine in Parkinson disease dementia .
CONCLUSIONS	The rate of worsening of motor symptoms was in the range expected due to the natural progression of Parkinson disease , no new or unexpected safety issues emerged in the long-term .

###24986183
OBJECTIVE	This study delineates activities of daily living ( ADL ) and instrumental activities of daily living ( IADL ) black-white disparity trends by age , period , and cohort ( APC ) and explores sociodemographic contributors of cohort-based disparity trends .
METHODS	We utilized multiple cross-sectional waves of National Health Interview Survey data ( 1982-2009 ) to describe APC trends of ADL and IADL disparities using a cross-classified random effect model .
METHODS	Further , we decomposed the cohort-based disparity trends using Fairlie 's decomposition method for nonlinear outcomes .
RESULTS	The crossover ADL and IADL disparities ( whites > blacks ) occurring at age 75 increased with age and reached a plateau at age of 80 , whereas period-based ADL and IADL disparities remained constant for the past 3 decades .
RESULTS	The cohort disparity trends for both disabilities showed a decline with each successive cohort except for ADL disparity among women .
CONCLUSIONS	We examined the role of aging on racial disparity in disability and found support for the racial crossover effect .
CONCLUSIONS	Further , the racial disparity in disability will disappear should the observed pattern of declining cohort-based ADL and IADL disparities persist .
CONCLUSIONS	Although education , income , and marital status are important sociodemographic contributors to cohort disparity trends , future studies should investigate individual behavioral health determinants and cohort-specific characteristics that explain the cohort-based racial difference in ADL and IADL disabilities .

###24669014
BACKGROUND	Randomized trials have not shown major survival benefits when induction chemotherapy plus standard therapy is compared with standard therapy alone in patients with oral squamous cell carcinoma ( OSCC ) .
BACKGROUND	Induction chemotherapy is likely to be effective for biologically distinct subgroups and biomarker development may lead to identification of patients whose tumors are likely to respond to a particular treatment .
METHODS	We evaluated immunohistochemical staining for GDF15 in pretreatment biopsy specimens of 230 of 256 OSCC patients who were treated in a prospective , randomized , phase III trial on induction chemotherapy including docetaxel , cisplatin and 5-fluorouracil ( TPF ) .
METHODS	Relationship between GDF15 intervention and cell proliferation , migration , invasion , colony formation and tumorigenicity was analyzed using in vitro and in vivo OSCC models .
RESULTS	Low GDF15 expression predicted a better survival in OSCC patients , especially overall survival [ P = 0.049 , hazard ratio ( HR ) = 0.597 ] and distant metastasis-free survival ( DMFS ; P = 0.031 , HR = 0.562 ) .
RESULTS	cN + patients with low GDF15 expression benefitted from induction TPF in overall survival ( P = 0.039 , HR = 0.247 ) and DMFS ( P = 0.039 , HR = 0.247 ) , cN - patients with high GDF15 expression benefitted from induction TPF in overall survival ( P = 0.019 , HR = 0.231 ) , disease-free survival ( P = 0.011 , HR = 0.281 ) , locoregional recurrence-free survival ( P = 0.035 , HR = 0.347 ) and DMFS ( P = 0.009 , HR = 0.197 ) .
RESULTS	Decreased GDF15 expression in OSCC lines significantly inhibited cell proliferation , migration , invasion , colony formation and tumorigenesis through increased phosphorylation of AKT and ERK1/2 ( P < 0.05 ) .
RESULTS	Likewise , overexpression of GDF15 significantly promoted cell proliferation , migration , invasion and colony formation through decreased phosphorylation of AKT and ERK1/2 ( P < 0.05 ) .
CONCLUSIONS	GDF15 expression can be used as a prognostic biomarker for OSCC , and as a predictive biomarker for benefitting from TPF induction chemotherapy .
CONCLUSIONS	GDF15 promotes tumorigenesis and progression through phosphorylation of AKT and ERK1/2 in OSCC .
CONCLUSIONS	The clinical trial in this study was registered with www.ClinicalTrials.gov ( NCT01542931 ) .

###24681657
BACKGROUND	The continued use of angiotensin-converting enzyme inhibitors ( ACEIs ) and angiotensin II subtype I receptor antagonists ( ARBs ) medications in the preoperative period has been reported to be associated with intraoperative hypotension that can be unresponsive to pressor drugs .
BACKGROUND	As a result , several investigators suggested discontinuation of these medications before scheduled surgery but did not report on unintended consequences that might result from discontinuation .
BACKGROUND	We conducted a prospective , single-blind , randomized trial to observe the effect of the medications on preoperative arterial blood pressure recordings in patients presenting for ambulatory and same-day surgery .
METHODS	Six hundred forty-four patients presenting for ambulatory and same-day surgery were enrolled prospectively between 2006 and 2011 and randomly assigned to 2 groups based on continuation or discontinuation of ACEIs and ARBs .
METHODS	An intention-to-treat analysis was performed .
METHODS	The primary outcome was presence of hypertension ( HTN ) immediately before surgery .
METHODS	Secondary outcomes included surgical cancellations due to HTN , prolongation of hospitalization , adverse clinical events , and HTN in the postoperative period .
RESULTS	Data for 526 patients were analyzed .
RESULTS	There were 262 patients in the discontinuation group and 264 patients in the continuation group .
RESULTS	Discontinuation of ACEIs and ARBs on the day of surgery was not associated with increased prevalence of preoperative HTN ( P = 0.775 ) .
RESULTS	The upper bound of a 95 % confidence interval for the difference in prevalence of Stage 1 and 2 HTN between study arms indicates that discontinuation of study medication is unlikely to be associated with an increase in Stage 1 HTN of > 4.8 percentage points and in Stage 2 HTN of no > 5.8 percentage points .
RESULTS	Discontinuation was not associated with an increase in postoperative HTN , with prolongation of hospitalization or with adverse clinical events .
CONCLUSIONS	Discontinuing ACEIs and ARBs in patients on the day of surgery did not result in a substantively increased incidence of pre - or postoperative HTN compared with patients who continued these medications on the day of surgery .
CONCLUSIONS	The results provide an evidentiary basis for the safety of discontinuing ACEIs and ARBs on the day of surgery without increasing adverse hemodynamic outcomes .

###25917730
OBJECTIVE	To evaluate efficacy and safety of superior hypogastric plexus neurolysis ( SHN ) for treatment of interstitial cystitis ( IC ) - bladder pain syndrome ( BPS ) in comparison with bladder hydrodistention ( HD ) .
METHODS	In a prospective study , 24 female patients were randomly allocated to receive either SHN or HD .
METHODS	Patients were evaluated by recording the O'Leary-Sant IC symptom indices , IC problem indices , pain visual analog scale ( VAS ) , number of daytime frequency , and nocturia .
METHODS	Pressure flow study was conducted for all patients .
METHODS	Intraoperative and postoperative changes and adverse events were recorded .
RESULTS	Basal IC symptom indices , IC problem indices , and VAS scores were comparable between both groups ( P = .31 , .63 , and .94 , respectively ) .
RESULTS	There was no statistically significant difference between both groups with respect to urodynamic parameters .
RESULTS	Only pain VAS at first week was improved in SHN in comparison with HD ( P = .012 ) .
RESULTS	Thereafter , all parameters were significantly improved in favor of the HD group at 2 - and 4-week visits .
RESULTS	Adverse events in both groups were ranked as Grade 1 Clavien-Dindo classification including transient hematuria in the HD group and transient back ache in the SHN group .
CONCLUSIONS	Despite effective pain control in cases with IC-BPS after SHN , it lacks durability .
CONCLUSIONS	It seems that SHN in its current form is not to be a suitable line of treatment for IC-BPS .
CONCLUSIONS	Multimodality treatment would be needed for proper control of patients ' symptoms .

###24687165
OBJECTIVE	Recent studies show that cerebral - amyloid ( A ) deposition is associated with blood pressure and measures of arterial stiffness in nondemented individuals .
OBJECTIVE	To examine the association between measures of arterial stiffness and change in A deposition over time .
METHODS	Deposition of A was determined in a longitudinal observational study of aging by positron emission tomography using the Pittsburgh compound B twice 2 years apart in 81 nondemented individuals 83 years and older .
METHODS	Arterial stiffness was measured with a noninvasive and automated waveform analyzer at the time closest to the second positron emission tomography scan .
METHODS	All measures were performed under standardized conditions .
METHODS	Pulse wave velocity ( PWV ) was measured in the central ( carotid-femoral and heart-femoral PWV ) , peripheral ( femoral-ankle PWV ) , and mixed ( brachial-ankle PWV ) vascular beds .
METHODS	The change in A deposition over 2 years was calculated from the 81 individuals with repeat A-positron emission tomography .
RESULTS	The proportion of A-positive individuals increased from 48 % at baseline to 75 % at follow-up .
RESULTS	Brachial-ankle PWV was significantly higher among A-positive participants at baseline and follow-up .
RESULTS	Femoral-ankle PWV was only higher among A-positive participants at follow-up .
RESULTS	Measures of central stiffness and blood pressure were not associated with A status at baseline or follow-up , but central stiffness was associated with a change in A deposition over time .
RESULTS	Each standard deviation increase in central stiffness ( carotid-femoral PWV , P = .001 ; heart-femoral PWV , P = .004 ) was linked with increases in A deposition over 2 years .
CONCLUSIONS	This study showed that A deposition increases with age in nondemented individuals and that arterial stiffness is strongly associated with the progressive deposition of A in the brain , especially in this age group .
CONCLUSIONS	The association between A deposition changes over time and generalized arterial stiffness indicated a relationship between the severity of subclinical vascular disease and progressive cerebral A deposition .

###24939519
BACKGROUND	This study investigates measures of mindfulness meditation ( MM ) as a mental practice , in which a resting but alert state of mind is maintained .
BACKGROUND	A population of older people with high stress level participated in this study , while electroencephalographic ( EEG ) and respiration signals were recorded during a MM intervention .
BACKGROUND	The physiological signals during meditation and control conditions were analyzed with signal processing .
METHODS	EEG and respiration data were collected and analyzed on 34 novice meditators after a 6-week meditation intervention .
METHODS	Collected data were analyzed with spectral analysis , phase analysis and classification to evaluate an objective marker for meditation .
RESULTS	Different frequency bands showed differences in meditation and control conditions .
RESULTS	Furthermore , we established a classifier using EEG and respiration signals with a higher accuracy ( 85 % ) at discriminating between meditation and control conditions than a classifier using the EEG signal only ( 78 % ) .
CONCLUSIONS	Support vector machine ( SVM ) classifier with EEG and respiration feature vector is a viable objective marker for meditation ability .
CONCLUSIONS	This classifier should be able to quantify different levels of meditation depth and meditation experience in future studies .

###25441408
OBJECTIVE	This randomised phase II trial aimed to compare efficacy of the irreversible ErbB family blocker , afatinib , with cetuximab in patients with KRAS wild-type metastatic colorectal adenocarcinoma ( mCRC ) with progression following oxaliplatin - and irinotecan-based regimens .
OBJECTIVE	Efficacy in patients with KRAS mutations was also evaluated .
METHODS	Patients with KRAS wild-type tumours were randomised 2:1 to afatinib ( 40 mg/day , increasing to 50 mg/day if minimal toxicity ) or cetuximab weekly ( 400 mg/m2 loading dose , then 250 mg/m2/week ) according to number of previous chemotherapy lines .
METHODS	All patients with KRAS-mutated tumours received afatinib .
METHODS	Primary end-points were objective response ( OR ) for the wild-type group and disease control for the KRAS-mutated group .
METHODS	Secondary end-points were progression-free survival ( PFS ) and overall survival ( OS ) .
RESULTS	Patients with KRAS wild-type tumours ( n = 50 ) received afatinib ( n = 36 ) or cetuximab ( n = 14 ) .
RESULTS	Unconfirmed and confirmed ORs were 3 % and 0 % for afatinib versus 20 % and 13 % for cetuximab ( odds ratio : 0.122 [ P = 0.0735 ] and < 0.001 , respectively ) .
RESULTS	Median PFS was 46.0 and 144.5 days for afatinib and cetuximab , respectively .
RESULTS	Median OS was 355 days with afatinib but not reached for cetuximab .
RESULTS	In the KRAS-mutated group ( n = 41 ) , five ( 12 % ) patients achieved confirmed disease control ( stable disease ; P = 0.6394 [ comparison versus 10 % ] ) ; no ORs were reported .
RESULTS	Median PFS and OS were 41.0 and 173days , respectively .
RESULTS	Most frequent treatment-related adverse events were diarrhoea and rash across groups .
CONCLUSIONS	The efficacy of afatinib was inferior to cetuximab in patients with KRAS wild-type mCRC .
CONCLUSIONS	In patients with KRAS-mutated tumours , disease control was modest with afatinib .
CONCLUSIONS	Afatinib had a manageable safety profile .

###24430095
OBJECTIVE	Heart failure and left ventricular systolic dysfunction ( LVSD ) are common in patients with permanent pacemakers , but whether right ventricular ( RV ) pacing is contributory or merely a bystander in patients with more severe cardiac disease is controversial .
OBJECTIVE	The aim of the present study was to determine whether reprogramming of existing pacemakers to reduce RV pacing is safe and leads to improvements in cardiac function .
METHODS	This was a prospective service evaluation of the effects of optimising pacemaker programming to avoid RV pacing in 66 consecutive attendees of a teaching hospital pacemaker clinic without complete heart block .
METHODS	The main outcome measures were left ventricular ejection fraction ( LVEF ) , N-terminal pro-B-type natriuretic peptide ( NT-pro-BNP ) levels , quality of life and cardiopulmonary exercise testing at baseline and after 6 months .
RESULTS	At 6 months , the protocol reduced absolute RV pacing by a mean of 49 % ( 95 % CI 41 % to 57 % ) ( p < 0.0001 from baseline ) and resulted in a mean absolute improvement in LVEF of 6 % ( 4 % to 8 % ) ( p < 0.0001 from baseline ) but no reduction in exercise capacity , NT-pro-BNP or quality of life .
RESULTS	There was a relationship between the magnitude of change in EF and the reduction in RV pacing ( p = 0.04 ) and changes in NT-pro-BNP seemed to relate to change in RV pacing ( p = 0.07 ) .
CONCLUSIONS	Programming standard pacemakers to avoid RV pacing is safe , does not adversely affect patients ' symptoms or quality of life and is associated with improved LV function , related to the reductions in RV pacing percentage .

###24628961
BACKGROUND	New technologies could facilitate changes in lifestyle and improve public health .
BACKGROUND	However , no large randomized , controlled studies providing scientific evidence of the benefits of their use have been made .
BACKGROUND	The aims of this study are to develop and validate a smartphone application , and to evaluate the effect of adding this tool to a standardized intervention designed to improve adherence to the Mediterranean diet and to physical activity .
BACKGROUND	An evaluation is also made of the effect of modifying habits upon vascular structure and function , and therefore on arterial aging .
METHODS	A randomized , double-blind , multicenter , parallel group clinical trial will be carried out .
METHODS	A total of 1215 subjects under 70years of age from the EVIDENT trial will be included .
METHODS	Counseling common to both groups ( control and intervention ) will be provided on adaptation to the Mediterranean diet and on physical activity .
METHODS	The intervention group moreover will receive training on the use of a smartphone application designed to promote a healthy diet and increased physical activity , and will use the application for three months .
METHODS	The main study endpoints will be the changes in physical activity , assessed by accelerometer and the 7-day Physical Activity Recall ( PAR ) interview , and adaptation to the Mediterranean diet , as evaluated by an adherence questionnaire and a food frequency questionnaire ( FFQ ) .
METHODS	Evaluation also will be made of vascular structure and function based on central arterial pressure , the radial augmentation index , pulse velocity , the cardio-ankle vascular index , and carotid intima-media thickness .
CONCLUSIONS	Confirmation that the new technologies are useful for promoting healthier lifestyles and that their effects are beneficial in terms of arterial aging will have important clinical implications , and may contribute to generalize their application in favor of improved population health .
BACKGROUND	Clinical Trials.gov Identifier : NCT02016014 .

###24658396
OBJECTIVE	To investigate the safety , feasibility and preliminary efficacy of low-frequency repetitive transcranial magnetic stimulation ( rTMS ) over the cerebellum in ataxic patients with acute posterior circulation stroke .
METHODS	Randomized , double-blind , sham-controlled pilot study .
METHODS	Thirty-two ataxic patients with posterior circulation stroke were randomized to real ( n = 22 ) and sham ( n = 10 ) rTMS groups .
METHODS	Patients received 5 15-min sessions of 1 Hz cerebellar rTMS over 5 consecutive days .
METHODS	Compliance and adverse events for the rTMS sessions were checked .
METHODS	The 10-m walk test ( 10MWT ) and Berg Balance Scale ( BBS ) were completed before rTMS , immediately and 1 month after the last rTMS session .
RESULTS	Compliance with the rTMS was 100 % and no adverse events were reported in either group .
RESULTS	10MWT and BBS of real rTMS group improved significantly ( p < 0.01 ) .
RESULTS	Percentage changes immediately after the last rTMS session for time and steps in the 10MWT and BBS in the real vs sham group were : -16.7 35.1 % vs -8.4 72.5 % , -8.5 23.0 % vs -0.3 28.4 % and 46.4 100.2 % vs 36.6 71.6 % , respectively .
CONCLUSIONS	This study demonstrated that 1 Hz rTMS over the cerebellum is safe , feasible and may have a beneficial effect in ataxic patients with posterior circulation stroke .

###25639137
BACKGROUND	Because of its contribution to dietary diversity and to favorable intakes of micronutrients , including iron and zinc , meat is hypothesized to be a valuable complementary food for the infant and young child .
BACKGROUND	However , the evidence base remains limited .
OBJECTIVE	To compare the difference in anthropometric measurements of rural Chinese infants and toddlers 6 to 18 months of age who received a daily supplement of meat or cereal for 12 months .
METHODS	This cluster-randomized , controlled study provided a daily supplement of either meat ( n = 514 , 20 clusters ) or cereal ( n = 957 , 40 clusters ) starting as a first complementary food at 6 months of age .
METHODS	Anthropometric measurements were assessed longitudinally .
RESULTS	After 12 months of intervention , the meat group ( 13.01 1.9 cm ) had greater ( p = .01 ) linear growth than the cereal group ( 12.75 1.8 cm ) and a smaller decrease in length-for-age z-score ( LAZ ) over time ( -0.43 0.72 in the meat group vs. -0.54 0.67 in the cereal group ) , after adjustment for baseline length , LAZ , maternal education , work status , and maternal height and weight .
CONCLUSIONS	Linear growth was modestly greater in the meat group than in the cereal group .
CONCLUSIONS	LAZ was substantially negative at 6 months , and the intervention did not prevent ongoing decline over the course of the study .

###24559487
BACKGROUND	Poor sleep is prevalent in patients with systemic inflammatory disorders , including rheumatoid arthritis , and , in addition to fatigue , pain , depression and inflammation , is associated with an increased risk of co-morbidity and all-cause mortality .
BACKGROUND	Whereas non-pharmacological interventions in patients with rheumatoid arthritis have been shown to reduce pain and fatigue , no randomized controlled trials have examined the effect of non-pharmacological interventions on improvement of sleep in patients with rheumatoid arthritis .
BACKGROUND	The aim of this trial was to evaluate the efficacy of an intermittent aerobic exercise intervention on sleep , assessed both objectively and subjectively in patients with rheumatoid arthritis .
METHODS	A randomized controlled trial including 44 patients with rheumatoid arthritis randomly assigned to an exercise training intervention or to a control group .
METHODS	The intervention consists of 18 session intermittent aerobic exercise training on a bicycle ergometer three times a week .
METHODS	Patients are evaluated according to objective changes in sleep as measured by polysomnography ( primary outcome ) .
METHODS	Secondary outcomes include changes in subjective sleep quality and sleep disturbances , fatigue , pain , depressive symptoms , physical function , health-related quality of life and cardiorespiratory fitness .
CONCLUSIONS	This trial will provide evidence of the effect of intermittent aerobic exercise on the improvement of sleep in patients with rheumatoid arthritis , which is considered important in promotion of health and well-being .
CONCLUSIONS	As such , the trial meets a currently unmet need for the provision of non-pharmacological treatment initiatives of poor sleep in patients with rheumatoid arthritis .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01966835 .

###24711481
OBJECTIVE	Syncope is a cause of significant morbidity in sick sinus syndrome ( SSS ) which may not be resolved with permanent pacemaker therapy .
OBJECTIVE	We aimed to determine the incidence , predictors and prognostic implication of syncope in paced patients with SSS .
METHODS	We studied 1415 patients ( mean age 72.9 years , SD 11.1 ) with SSS who were randomised in the DANPACE study to either rate-responsive single chamber pacing ( n = 707 ) or rate-responsive dual chamber pacing ( n = 708 ) .
METHODS	Main outcome measures were patient-reported syncope after pacemaker implantation and mortality .
RESULTS	Mean follow-up was 5.4 years ( SD 2.6 ) .
RESULTS	A total of 247 ( 17.5 % ) patients experienced syncope after pacemaker implantation ( 135 ( 19 % ) from the rate-responsive single chamber pacing group , and 112 ( 15.8 % ) from the rate-responsive dual chamber pacing group .
RESULTS	Predictors of syncope post pacemaker implantation included : age 0-39 years ( HR 2.9 , 95 % CI 1.4 to 6.3 , p = 0.01 ; reference range 60-79 years ) , age 80 years ( HR 1.4 , 95 % CI 1.0 to 1.8 , p = 0.03 ) , syncope prior to pacemaker implant ( HR 1.8 , 95 % CI 1.4 to 2.3 , p < 0.001 ) , previous myocardial infarction ( HR 1.5 , 95 % CI 1.1 to 2.1 , p = 0.03 ) , heart failure ( HR 1.4 , 95 % CI 1.0 to 1.9 , p = 0.046 ) , and high Charlson comorbidity index ( HR 1.6 , 95 % CI 1.1 to 2.2 , p = 0.01 ) .
RESULTS	Patients who experienced syncope post pacemaker implant had higher mortality compared with patients who did not ( adjusted HR 1.6 , 95 % CI 1.3 to 2.1 , p < 0.001 ) .
CONCLUSIONS	Syncope in paced patients with SSS is common , and is associated with higher mortality .
CONCLUSIONS	The predictors identified in this study suggest a multifactorial aetiology of syncope .

###26252845
BACKGROUND	Surgery remains the dominant treatment for large-bowel obstruction , with emerging data on self-expanding metallic stents .
OBJECTIVE	The aim of this study was to assess whether stent insertion improves quality of life and survival in comparison with surgical decompression .
METHODS	This study reports on a randomized control trial ( registry number ACTRN012606000199516 ) .
METHODS	This study was conducted at Royal Prince Alfred Hospital , Sydney , and Western Hospital , Melbourne .
METHODS	Patients with malignant incurable large-bowel obstruction were randomly assigned to surgical decompression or stent insertion .
METHODS	The primary end point was differences in EuroQOL EQ-5D quality of life .
METHODS	Secondary end points included overall survival , 30-day mortality , stoma rates , postoperative recovery , complications , and readmissions .
RESULTS	Fifty-two patients of 58 needed to reach the calculated sample size were evaluated .
RESULTS	Stent insertion was successful in 19 of 26 ( 73 % ) patients .
RESULTS	The remaining 7 patients required a stoma compared with 24 of 26 ( 92 % ) surgery group patients ( p < 0.001 ) .
RESULTS	There were no stent-related perforations or deaths .
RESULTS	The surgery group had significantly reduced quality of life compared with the stent group from baseline to 1 and 2 weeks ( p = 0.001 and p = 0.012 ) , and from baseline to 12 months ( p = 0.01 ) in favor of the stent group , whereas both reported reduced quality of life .
RESULTS	The stent group had an 8 % 30-day mortality compared with 15 % for the surgery group ( p = 0.668 ) .
RESULTS	Median survival was 5.2 and 5.5 months for the groups ( p = 0.613 ) .
RESULTS	The stent group had significantly reduced procedure time ( p = 0.014 ) , postprocedure stay ( p = 0.027 ) , days nothing by mouth ( p = 0.002 ) , and days before free access to solids ( p = 0.022 ) .
CONCLUSIONS	This study was limited by the lack of an EQ-5D Australian-based population set .
CONCLUSIONS	Stent use in patients with incurable large-bowel obstruction has a number of advantages with faster return to diet , decreased stoma rates , reduced postprocedure stay , and some quality-of-life benefits .

###24529619
OBJECTIVE	To identify risk factors for headache and migraine in children with sickle cell disease and test the hypothesis that either or both are independently associated with silent cerebral infarcts .
METHODS	In this cross-sectional study , we evaluated the health history , laboratory values , and brain magnetic resonance imaging findings of participants with sickle cell disease ( hemoglobinSS or hemoglobinS-thalassemia ) with no history of overt stroke or seizures .
METHODS	Participants characterized headache severity and quality .
METHODS	Migraine was defined by International Headache Society criteria modified for increased sensitivity in children .
METHODS	Neuroradiology and neurology committees adjudicated the presence of silent cerebral infarction by review of magnetic resonance imaging and standardized examination by pediatric neurologists .
RESULTS	The cohort included 872 children ( 51.1 % males ) , ranging in age from 5 to 15 years ( mean age , 9.1 years ) .
RESULTS	Of these children , 317 ( 36.4 % ) reported recurrent headaches , and 132 ( 15.1 % ) reported migraines .
RESULTS	In multivariable logistic regression analyses , both were associated with lower steady-state hemoglobin ( P = .01 for headaches ; P < .01 for migraines ) and higher pain rate ( P < .01 for headaches ; P < .01 for migraines ) , defined as the number of admissions requiring opioids in the previous 3 years .
RESULTS	The presence of silent cerebral infarction was not associated with recurrent headaches or migraines .
RESULTS	Only 1.9 % ( 6 of 317 ) of children with recurrent headaches received medication for headache prophylaxis .
CONCLUSIONS	Recurrent headaches and migraines are common and undertreated in children with sickle cell disease .
CONCLUSIONS	Low hemoglobin levels and high pain rates are associated with recurrent headaches and migraines ; whereas , silent cerebral infarction is not .

###25684586
BACKGROUND	Roflumilast reduces exacerbations in patients with severe chronic obstructive pulmonary disease .
BACKGROUND	Its effect in patients using fixed combinations of inhaled corticosteroids and longacting 2 agonists is unknown .
BACKGROUND	We postulated that roflumilast would reduce exacerbations in patients with severe chronic obstructive pulmonary disease at risk for exacerbations , even in combination with inhaled corticosteroid and longacting 2 agonist treatment .
METHODS	For this 1-year double-blind , placebo-controlled , parallel group , multicentre , phase 3-4 trial , the Roflumilast and Exacerbations in patients receiving Appropriate Combination Therapy ( REACT ) study , we enrolled patients with severe chronic obstructive pulmonary disease from 203 centres ( outpatient clinics , hospitals , specialised pulmonologists , and family doctors ) in 21 countries .
METHODS	Eligible patients were 40 years of age or older with a smoking history of at least 20 pack-years and a diagnosis of chronic obstructive pulmonary disease with severe airflow limitation , symptoms of chronic bronchitis , and at least two exacerbations in the previous year .
METHODS	We used a computerised central randomisation system to randomly assign patients in a 1:1 ratio to the two treatment groups : roflumilast 500 g or placebo given orally once daily together with a fixed inhaled corticosteroid and longacting 2 agonist combination .
METHODS	Background tiotropium treatment was allowed .
METHODS	All patients and investigators were masked to group assignment .
METHODS	The primary outcome was the rate of moderate to severe chronic obstructive pulmonary disease exacerbations per patient per year , analysed by intention to treat .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01329029 .
RESULTS	Between April 3 , 2011 , and May 27 , 2014 , we enrolled 1945 eligible participants and randomly assigned 973 to the roflumilast group and 972 to the placebo group .
RESULTS	The rate of moderate-to-severe chronic obstructive pulmonary disease exacerbations was 132 % lower in the roflumilast group than in the placebo group according to a Poisson regression analysis ( roflumilast 0805 vs placebo 0927 ; rate ratio [ RR ] 0868 [ 95 % CI 0753-1002 ] , p = 00529 ) , and 142 % lower according to a predefined sensitivity analysis using negative binomial regression ( 0823 vs 0959 ; 0858 [ 0740-0995 ] , p = 00424 ) .
RESULTS	Adverse events were reported by 648 ( 67 % ) of 968 patients receiving roflumilast and by 572 ( 59 % ) of 967 patients in the placebo group ; adverse event-associated patient withdrawal from the study was also more common in the roflumilast group ( 104/968 [ 11 % ] ) than in the placebo group ( 52/967 [ 5 % ] ) .
RESULTS	The most frequently reported serious adverse events were chronic obstructive pulmonary disease exacerbations and pneumonia , and 17 ( 18 % ) deaths occurred in the roflumilast group compared with 18 ( 19 % ) in the placebo group .
CONCLUSIONS	Our findings suggest that roflumilast reduces exacerbations and hospital admissions in patients with severe chronic obstructive pulmonary disease and chronic bronchitis who are at risk of frequent and severe exacerbations despite inhaled corticosteroid and longacting 2 agonist therapy , even in combination with tiotropium .
BACKGROUND	Takeda .

###25448244
OBJECTIVE	To test the proposed mechanism of action of a task-specific motor learning intervention by examining its effect on measures of the motor control of gait .
METHODS	Single-blinded randomized clinical trial .
METHODS	University research laboratory .
METHODS	Adults ( N = 40 ) aged 65 years with gait speed > 1.0 m/s and impaired motor skill ( figure-of-8 walk time > 8s ) .
METHODS	The 2 interventions included a task-oriented motor learning and a standard exercise program ; both interventions included strength training .
METHODS	Both lasted 12 weeks , with twice-weekly , 1-hour , physical therapist-supervised sessions .
METHODS	Two measures of the motor control of gait , gait variability and smoothness of walking , were assessed pre - and postintervention by assessors masked to the treatment arm .
RESULTS	Of 40 randomized subjects , 38 completed the trial ( mean age SD , 77.16.0 y ) .
RESULTS	The motor learning group improved more than the standard group in double-support time variability ( .13 m/s vs .05 m/s ; adjusted difference [ AD ] = .006 , P = .03 ) .
RESULTS	Smoothness of walking in the anteroposterior direction improved more in the motor learning than standard group for all conditions ( usual : AD = .53 , P = .05 ; narrow : AD = .56 , P = .01 ; dual task : AD = .57 , P = .04 ) .
RESULTS	Smoothness of walking in the vertical direction also improved more in the motor learning than standard group for the narrow-path ( AD = .71 , P = .01 ) and dual-task ( AD = .89 , P = .01 ) conditions .
CONCLUSIONS	Among older adults with subclinical walking difficulty , there is initial evidence that task-oriented motor learning exercise results in gains in the motor control of walking , while standard exercise does not .
CONCLUSIONS	Task-oriented motor learning exercise is a promising intervention for improving timing and coordination deficits related to mobility difficulties in older adults , and needs to be evaluated in a definitive larger trial .

###25440377
OBJECTIVE	In an attempt to investigate new strategies aimed at reducing inflammation in osteoarthritis , the anti-inflammatory effect of Elaeagnus angustifolia L. as a complementary treatment was evaluated in females with knee osteoarthritis .
METHODS	In this clinical trial , 90 females with mild to moderate osteoarthritis were assigned to two intervention and one placebo groups .
METHODS	In addition to the conventional therapy , the patients in intervention groups received 15g/day of E. angustifolia L. medulla and whole fruit powders respectively for 8 weeks .
METHODS	The levels of tumor necrosis factor-alpha ( TNF - ) , interleukine-1 ( IL-1 ) , interleukine-10 ( IL-10 ) , matrix metalloproteinase-1 ( MMP-1 ) and -13 ( MMP-13 ) were measured with human ELISA kits .
METHODS	Paired t-test and ANOVA were used for statistical analysis .
RESULTS	The statistically significant decrease was observed in the mean levels of serum TNF - in the medulla ( 0.004 ) and whole fruit ( 0.001 ) groups after 8 weeks of supplementation .
RESULTS	In contrast to the placebo group , there was a significant rise in the mean levels of serum IL-10 in medulla ( p-value = 0.01 ) and whole fruit groups ( p-value = 0.009 ) at the end of study .
RESULTS	The interventions resulted in significant decrease in the mean levels of serum MMP-1 in the medulla ( 0.001 ) and whole fruit ( 0.002 ) groups .
RESULTS	After the interventions , no significant changes were observed in the serum IL-1 and MMP-13 levels .
CONCLUSIONS	Daily supplementation with E. angustifolia L. in both forms of medulla and whole fruit powders appeared to be effective for decreasing inflammatory cytokines ( TNF - and MMP-1 ) and enhancing anti-inflammatory cytokines ( IL-10 ) .

###24925122
OBJECTIVE	We investigated whether objectively measured sedentary time was associated with markers of inflammation in adults with newly diagnosed type 2 diabetes .
RESULTS	We studied 285 adults ( 184 men , 101 women , mean age 59.0 9.7 ) who had been recruited to the Early ACTivity in Diabetes ( Early ACTID ) randomised controlled trial .
RESULTS	C-reactive protein ( CRP ) , adiponectin , soluble intracellular adhesion molecule-1 ( sICAM-1 ) , interleukin-6 ( IL-6 ) , and accelerometer-determined sedentary time and moderate-vigorous physical activity ( MVPA ) were measured at baseline and after six-months .
RESULTS	Linear regression analysis was used to investigate the independent cross-sectional and longitudinal associations of sedentary time with markers of inflammation .
RESULTS	At baseline , associations between sedentary time and IL-6 were observed in men and women , an association that was attenuated following adjustment for waist circumference .
RESULTS	After 6 months of follow-up , sedentary time was reduced by 0.4 1.2 h per day in women , with the change in sedentary time predicting CRP at follow-up .
RESULTS	Every hour decrease in sedentary time between baseline and six-months was associated with 24 % ( 1 , 48 ) lower CRP .
RESULTS	No changes in sedentary time between baseline and 6 months were seen in men .
CONCLUSIONS	Higher sedentary time is associated with IL-6 in men and women with type 2 diabetes , and reducing sedentary time is associated with improved levels of CRP in women .
CONCLUSIONS	Interventions to reduce sedentary time may help to reduce inflammation in women with type 2 diabetes .

###24524601
OBJECTIVE	To investigate the lipid-regulating effect and safety of combined statin and bezafibrate therapy in acute coronary syndrome ( ACS ) patients complicating with dyslipedemia .
METHODS	One hundred and four hospitalized patients with established ACS and increased serum triglycerides ( TG ) levels and/or low serum levels of high density lipoprotein cholesterol ( HDL-C ) were selected .
METHODS	Except for conventional therapy , the patients were randomly divided into 2 groups : control group ( n = 52 ) , treated with atorvastatin 20 mg qn or other statin equivalent to 20 mg atorvastatin ; treatment group ( n = 52 ) , treated with the same dose statin plus bezafibrate 200 mg bid .
METHODS	The serum levels of total cholesterol ( TC ) , TG , low-density lipoprotein cholesterol ( LDL-C ) and HDL-C were assessed before and after 6 and 12 weeks treatment , side effects and adverse events were recorded .
RESULTS	After 6 weeks treatment , the serum levels of TC , TG and LDL-C in two groups were significantly reduced compared to baseline ( all P < 0.05 ) , which were further declined after 12 weeks treatment , and the reduction was more significant in treatment group ( 29.8 % , 38.0 % and 36.1 % , respectively ) than in control group ( 14.7 % , 9.8 % and 26.7 % , respectively ) ( all P < 0.05 ) .
RESULTS	After treatment , the serum levels of HDL-C in the two groups were significantly higher than the baseline levels , especially after 12 weeks treatment ( all P < 0.05 ) , and the elevations of HDL-C levels in control group and in treatment group were 19.3 % and 24.2 % , respectively , but there were no significant difference between the two groups ( P > 0.05 ) .
RESULTS	After 12 weeks , the rates reaching to target goals of LDL-C , TG , HDL-C , and non-HDL-C levels in the treatment group ( 69.2 % , 88.5 % , 92.3 % , 46.2 % and 65.4 % , respectively ) were significantly higher than those in the control group ( 34.6 % , 65.4 % , 46.2 % , 7.7 % and 42.3 % , respectively , all P < 0.05 ) .
RESULTS	No serious side effects were observed in the two groups during the treatment period .
CONCLUSIONS	The combined statin and bezafibrate treatment is safe and could increase the ratios of reaching target lipid levels in ACS patients complicating with increased TG and ( or ) decreased HDL-C .

###25760554
BACKGROUND	Low-fluence Q-switched neodymium-doped yttrium-aluminum-garnet 1,064-nm laser ( LFQS ) and glycolic acid ( GA ) peeling have been reported as a treatment option for melasma .
BACKGROUND	However , there are limited data on their efficacy in men .
OBJECTIVE	To compare the efficacy and safety of LFQS monotherapy with combined LFQS and 30 % GA peeling in male patients with melasma .
METHODS	Fifteen males with mixed type melasma were randomized to receive 5 weekly sessions of LFQS on one side of the face and LFQS plus 30 % GA peeling on the contralateral side and were followed for 12 weeks .
METHODS	Twelve patients completed the protocol .
RESULTS	Mean relative lightness index ( RL * I ) of the combined treatment side was lowered throughout the study period , with the maximal improvement of 52.3 % reduction at the fourth week follow-up ( p = .023 ) .
RESULTS	Patient self-assessment was favorable in the combined treatment .
RESULTS	However , the mean RL * I increased at 8 and 12 weeks of follow-up .
RESULTS	One subject ( 8.3 % ) developed guttate hypopigmentation , which did not resolve by the 12-week follow-up .
CONCLUSIONS	Low-fluence Q-switched neodymium-doped yttrium-aluminum-garnet 1,064-nm laser combined with GA peeling temporarily reduced melasma in men , but the incidence of side effects does not justify the short-lived benefits of this procedure .
CONCLUSIONS	This technique requires further study .

###25043321
BACKGROUND	While physical exercise as adjunctive treatment for major depression has received considerable attention in recent years , the evidence is conflicting .
BACKGROUND	This study evaluates the effects of two different add-on treatments : exercise and basic body awareness therapy .
METHODS	Randomized controlled trial with two intervention groups and one control , including 62 adults on antidepressant medication , who fulfilled criteria for current major depression as determined by the Mini International Neuropsychiatric Interview .
METHODS	Interventions ( 10 weeks ) were aerobic exercise or basic body awareness therapy ( BBAT ) , compared to a single consultation with advice on physical activity .
METHODS	Primary outcome was depression severity , rated by a blinded assessor using the Montgomery Asberg Rating Scale ( MADRS ) .
METHODS	Secondary outcomes were global function , cardiovascular fitness , self-rated depression , anxiety and body awareness .
RESULTS	Improvements in MADRS score ( mean change = -10.3 , 95 % CI ( -13.5 to -7.1 ) , p = 0.038 ) and cardiovascular fitness ( mean change = 2.4 ml oxygen/kg/min , 95 % CI ( 1.5 to 3.3 ) , p = 0.017 ) were observed in the exercise group .
RESULTS	Per-protocol analysis confirmed the effects of exercise , and indicated that BBAT has an effect on self-rated depression .
CONCLUSIONS	The small sample size and the challenge of missing data .
CONCLUSIONS	Participants positive expectations regarding the exercise intervention need to be considered .
CONCLUSIONS	Exercise in a physical therapy setting seems to have effect on depression severity and fitness , in major depression .
CONCLUSIONS	Our findings suggest that physical therapy can be a viable clinical strategy to inspire and guide persons with major depression to exercise .
CONCLUSIONS	More research is needed to clarify the effects of basic body awareness therapy .

###24417602
OBJECTIVE	Interest in online positive psychology interventions ( OPPIs ) continues to grow .
OBJECTIVE	The empirical literature has identified design factors ( e.g. , variety and duration of activities ) and moderators ( e.g. , personality traits ) that can influence their effectiveness .
OBJECTIVE	A randomized controlled trial tested an empirically informed OPPI designed to promote self-efficacy and an optimistic outlook .
OBJECTIVE	Pessimism was included as a trait moderator .
METHODS	Participants ( N = 466 ) were English-speaking adults interested in becoming happier .
METHODS	They were randomly assigned to complete either an OPPI cultivating optimism or a control condition writing about daily activities for 3 weeks .
METHODS	Follow-up assessments occurred 1 and 2 months following the exercise period .
RESULTS	A hierarchical linear model analysis indicated that the optimism intervention increased the pursuit of engagement-related happiness in the short term and reduced dysfunctional attitudes across follow-ups .
RESULTS	Pessimistic individuals had more to gain and reported fewer depressive symptoms at post-test .
CONCLUSIONS	These findings support the conclusion that empirically informed online interventions can improve psychological well-being , at least in the short run , and may be particularly helpful when tailored to the needs of the individual .

###24929428
OBJECTIVE	Despite their independent cardiovascular disease ( CVD ) advantages , effects of - linolenic acid ( ALA ) , monounsaturated fatty acid ( MUFA ) , and low-glycemic-load ( GL ) diets have not been assessed in combination .
OBJECTIVE	We therefore determined the combined effect of ALA , MUFA , and low GL on glycemic control and CVD risk factors in type 2 diabetes .
METHODS	The study was a parallel design , randomized trial wherein each 3-month treatment was conducted in a Canadian academic center between March 2011 and September 2012 and involved 141 participants with type 2 diabetes ( HbA1c 6.5 % -8.5 % [ 48-69 mmol/mol ] ) treated with oral antihyperglycemic agents .
METHODS	Participants were provided with dietary advice on either a low-GL diet with ALA and MUFA given as a canola oil-enriched bread supplement ( 31 g canola oil per 2,000 kcal ) ( test ) or a whole-grain diet with a whole-wheat bread supplement ( control ) .
METHODS	The primary outcome was HbA1c change .
METHODS	Secondary outcomes included calculated Framingham CVD risk score and reactive hyperemia index ( RHI ) ratio .
RESULTS	Seventy-nine percent of the test group and 90 % of the control group completed the trial .
RESULTS	The test diet reduction in HbA1c units of -0.47 % ( -5.15 mmol/mol ) ( 95 % CI -0.54 % to -0.40 % [ -5.92 to -4.38 mmol/mol ] ) was greater than that for the control diet ( -0.31 % [ -3.44 mmol/mol ] [ 95 % CI -0.38 % to -0.25 % ( -4.17 to -2.71 mmol/mol ) ] , P = 0.002 ) , with the greatest benefit observed in those with higher systolic blood pressure ( SBP ) .
RESULTS	Greater reductions were seen in CVD risk score for the test diet , whereas the RHI ratio increased for the control diet .
CONCLUSIONS	A canola oil-enriched low-GL diet improved glycemic control in type 2 diabetes , particularly in participants with raised SBP , whereas whole grains improved vascular reactivity .

###24400934
BACKGROUND	Different types of exercises can help manage chronic neck pain .
BACKGROUND	Supervised exercise interventions are widely used , but these protocols require substantial resources .
BACKGROUND	The aim of this trial , which focused on adherence , was to evaluate two home exercise interventions .
METHODS	This parallel group randomized controlled trial included 57 women randomly allocated into two groups - a strength training group ( STRENGTH , 34 subjects ) and a stretching group ( STRETCH , 23 subjects ) .
METHODS	The interventions focused on the neck and shoulder muscles and lasted for 12 months .
METHODS	The STRENGTH group performed weight training and ended each session with stretching exercises .
METHODS	These stretching exercises constituted the entirety of the STRETCH group 's training session .
METHODS	Both groups were instructed to exercise three times per week .
METHODS	All the participants kept an exercise diary .
METHODS	In addition , all participants were offered support via phone and e-mail .
METHODS	The primary outcomes were pain intensity and function .
METHODS	The trial included a four - to six-month and a twelve-month follow-up .
METHODS	A completer in this study exercised at least 1,5 times per week during eight unbroken weeks .
METHODS	A responder in this study reported clinically significant improvements on pain and function .
METHODS	The statistical analyses used the Mann Whitney U-test , Wilcoxon signed-rank test , and X2 test .
RESULTS	At four - to six-months , the numbers of completers were 19 in the STRENGTH group and 17 in the STRETCH group .
RESULTS	At twelve months , the corresponding numbers were 11 ( STRENGTH ) and 10 ( STRETCH ) .
RESULTS	At four - to six-months , the proportions of subjects reporting clinically important changes ( STRENGTH and STRETCH ) were for neck pain : 47 % and 41 % , shoulder pain : 47 % and 47 % , function : 37 % and 29 % .
RESULTS	At twelve months , the corresponding numbers were for neck pain : 45 % and 40 % , shoulder pain : 55 % and 50 % , function : 55 % and 20 % .
CONCLUSIONS	No differences in the two primary outcomes between the two interventions were found , a finding that may be due to the insufficient statistical power of the study .
CONCLUSIONS	Both interventions based on home exercises improved the two primary outcomes , but the adherences were relatively low .
CONCLUSIONS	Future studies should investigate ways to improve adherence to home exercise treatments .
BACKGROUND	ClinicalTrials.gov Id : NCT01876680 .

###24934484
OBJECTIVE	We conducted a randomised , double blind , placebo controlled trial to assess the efficacy and safety of cilostazol , a selective inhibitor of phosphodiesterase 3 , in patients with vasospastic angina ( VSA ) .
BACKGROUND	Cilostazol has been shown to induce vascular dilatation , but its efficacy in patients with VSA is unknown .
METHODS	Between October 2011 and July 2012 , 50 patients with confirmed VSA who had 1 angina episodes/week despite amlodipine therapy ( 5mg/day ) were randomly assigned to receive either cilostazol ( up to 200mg/day ) or placebo for 4weeks .
METHODS	All patients were given diaries to record the frequency and severity of chest pain ( 0-10 grading ) .
METHODS	The primary endpoint was the relative reduction of the weekly incidence of chest pain .
RESULTS	Baseline characteristics were similar between the two groups .
RESULTS	Among 49 evaluable patients ( 25 in the cilostazol group , 24 in the placebo group ) , the primary endpoint was significantly greater in the cilostazol group compared with the placebo group ( -66.588.6 % vs -17.6140.1 % , respectively , p = 0.009 ) .
RESULTS	The secondary endpoints , including a change in the frequency of chest pain ( -3.70.5 vs -1.90.6 , respectively , p = 0.029 ) , a change in the chest pain severity scale ( -2.80.4 vs -1.10.4 , respectively , p = 0.003 ) , and the proportion of chest pain-free patients ( 76.0 % vs 33.3 % , respectively , p = 0.003 ) also significantly favoured cilostazol .
RESULTS	Headache was the most common adverse event in both groups ( 40.0 % vs 20.8 % , respectively , p = 0.217 ) .
CONCLUSIONS	Cilostazol is an effective therapy for patients with VSA uncontrolled by conventional amlodipine therapy , and has no serious side effects .
BACKGROUND	NCT01444885 .

###25881458
OBJECTIVE	To study the clinical effect of development theory based acupuncture on early cerebral palsy ( CP ) infants with parafunctional sitting position .
METHODS	Totally 120 early CP infants were randomly assigned to two groups equally , the treatment group and the control group .
METHODS	All received acupuncture combined with training rehabilitation .
METHODS	Patients in the treatment group adopted acupuncture based on infants development theory , while those in the control group were treated by head acupuncture .
METHODS	Sitting functional points in Gross motor function measure ( GMFM ) 88 were observed in different groups and infant patients of various types before and after treatment .
METHODS	Root mean square ( RMS ) signals of sitting correlated muscles ( latissimus dorsi , erector spinae , rectus abdominis ) were recorded by surface electromyography ( sEMG ) .
METHODS	The effective rate was evaluated by Nimodipine method .
RESULTS	Compared with before treatment , sitting functional points were significantly improved in the two groups ( P < 0.01 ) .
RESULTS	After treatment , it was higher in the treatment group than in the control group ( P < 0.01 ) .
RESULTS	The advance amplitude was higher in CP infants of the spastic type and the hypotonic type than other types ( P < 0.01 ) .
RESULTS	Along with sitting process , latissimus dorsi RMS signals were gradually tapered , erector spinae RMS signals were gradually enhanced , and rectus abdominis RMS signals were slightly weakened .
RESULTS	Compared with the control group , latissimus dorsi RMS signals obviously decreased , and erector spinae RMS signals obviously increased in the treatment group after treatment ( all P < 0.01 ) .
RESULTS	The total effective rate was higher in the treatment group than in the control group ( 89.29 % vs. 77.78 % , P < 0.05 ) .
CONCLUSIONS	Infants development theory based acupuncture could effectively elevate dorsi-extensor muscles force , improve sitting position of 8 months to 1 year old CP infants with parafunctional sitting position .

###25375054
BACKGROUND	Patients who underwent primary inguinal hernia repair still report a high rate of postoperative pain after operation due to the effect of mesh fixation by suture.An alternative is the use of human fibrin glue .
BACKGROUND	We compared the two techniques .
METHODS	468 patients randomly underwent primary inguinal hernia Lichtenstein repair fixing the mesh by suture or by human fibrin glue ( HFG ) ; in both cases the mesh was fixed to the posterior wall of the inguinal canal and to the inguinal ligament .
RESULTS	No significant differences were recorded between the two groups in terms of complications , while the sutureless technique reduces the operative time and the postoperative pain .
CONCLUSIONS	A widespread technique for the treatment of inguinal hernia is the application of a mesh using Lichtenstein procedure .
CONCLUSIONS	The prosthesis can be fixed by traditional suture or using a new method of sutureless fixation with adhesive materials that shows an excellent local tolerability and lack of adverse effects and contraindications .

###24482090
BACKGROUND	Uremic pruritus as a symptom that affects hemodialysis ( HD ) patients can decrease the quality of life and increase morbidity in these patients .
BACKGROUND	The aim of this study was to evaluate the effects of turmeric on uremic pruritus in HD patients .
METHODS	This was a double-blind placebo-controlled trial conducted on 100 HD patients suffering from pruritus .
METHODS	Patients ( mean age 53.3 15.8 years ) were randomized into two groups : turmeric and placebo .
METHODS	The pruritus score and biochemical determinants including high-sensitivity C-reactive protein ( hs-CRP ) were compared before and at the end of the study between the two groups .
RESULTS	The mean decrease in hs-CRP was significantly higher in the turmeric than the placebo group ( -0.8 2.6 vs. 0.4 8.7 mg/l , p = 0.012 ) .
RESULTS	Also reduction of pruritus scores was greater in the turmeric than the placebo group ( 13.6 2.6 vs. 7.2 2.6 , p = 0.001 ) .
RESULTS	No side effect was observed during the study due to the use of turmeric .
CONCLUSIONS	This study demonstrates the possible efficacy of turmeric in decreasing hs-CRP and uremic pruritus in end stage renal disease patients .
CONCLUSIONS	Future studies are needed to further evaluate the efficacy and safety of turmeric .

###25362672
BACKGROUND	Measurement of mixed venous oxygen saturation helps determine whether cardiac output and oxygen delivery are sufficient for metabolic needs .
BACKGROUND	As recommended by the American Association of Critical-Care Nurses guideline , blood samples for determining mixed venous oxygen saturation are obtained by slowly , in 1 to 2 minutes , withdrawing 1.5 mL of blood from the distal port of the pulmonary artery catheter .
BACKGROUND	In theory , the negative force of rapid withdrawal could pull oxygenated blood from the pulmonary capillary bed , causing falsely elevated saturation values .
OBJECTIVE	To determine if the speed of withdrawal affects oxygen content in blood samples used to measure mixed venous oxygen saturation .
METHODS	The sample consisted of heart failure patients with pulmonary artery catheters admitted to a cardiac intensive care unit .
METHODS	A prospective , randomized , 2 2 crossover design was used to compare mixed venous oxygen saturation in blood samples obtained quickly or slowly .
METHODS	A total of 50 sets of saturation values were analyzed .
METHODS	Each set included 1 blood sample obtained slowly , in 1 to 2 minutes , and 1 obtained rapidly , in 5 seconds .
RESULTS	The mean difference in saturation values between the fast and the slow groups was -0.3 ( CI , -1.5 to 0.8 ; P = .55 ) , indicating that no meaningful systematic bias is attributable to fast withdrawal of blood .
CONCLUSIONS	Rapid blood sampling does not falsely elevate measurements of mixed venous oxygen saturation .

###25227834
BACKGROUND	While many researchers often use a theoretical framework for mammogram repeat interventions , it seems they do not apply an identified mediation analysis method .
BACKGROUND	The aim of this study was to determine the mediators of mammogram replication behavior in two tailored interventions for non-adherent Iranian women .
METHODS	A sample population of 184 women over 50 years old in Sanandaj , Iran , was selected for an experiment .
METHODS	Participants were randomly allocated into one of the three conditions : 1 ) an intervention based on the Health Belief Model ( HBM ) 2 ) an intervention based on an integration of the HBM and selected constructs from the Theory of Planned Behavior ( TPB ) , and 3 ) a control group .
METHODS	Constructs were measured before the intervention , and after a 6-month follow-up .
RESULTS	Perceived self-efficacy , behavioral control , and subjective norms were recognized as mediators in the HBM and selected constructs from the TPB intervention .
RESULTS	Perceived susceptibility , severity , barriers , self-efficacy and behavioral control met the criteria for mediation in the HBM intervention .
CONCLUSIONS	This study was successful in establishing mediation in a sample of women .
CONCLUSIONS	Our findings enrich the literature on mammography repeat , indicating key intervention factors , and relegating redundant ones in the Iranian populations .
CONCLUSIONS	The use of strategies to increase mammography repeat , such HBM and TPB constructs is suggested to be important for maintaining a screening behavior , once the behavior has been adopted .

###24382603
OBJECTIVE	The study examined the efficacy of family-based and adolescent-only HIV prevention programs in decreasing HIV risk and improving parental monitoring and sexual communication among youths in mental health treatment .
METHODS	A randomized controlled trial ( RCT ) with 721 adolescents ( ages 13-18 years ) and their caregivers from mental health settings in three U.S. cities were randomly assigned to one of three theory-based , structured group interventions : family-based HIV prevention , adolescent-only HIV prevention , and adolescent-only health promotion .
METHODS	Interventions were delivered during an all-day workshop .
METHODS	Assessments were completed at baseline and three months postintervention .
RESULTS	Compared with those in the health intervention , adolescents in the HIV prevention interventions reported fewer unsafe sex acts ( adjusted rate ratio = .49 , p = .01 ) , greater condom use ( adjusted relative change = 59 % , p = .01 ) , and greater likelihood of avoiding sex ( adjusted odds ratio = 1.44 , p = .05 ) .
RESULTS	They also showed improved HIV knowledge ( p < .01 ) and self-efficacy ( p < .05 ) .
RESULTS	The family-based intervention , compared with the other interventions , produced significant improvements in parent-teen sexual communication ( p < .01 ) , parental monitoring ( p < .01 ) , and parental permissiveness ( p = .05 ) .
CONCLUSIONS	This RCT found that the HIV prevention interventions reduced sexual risk behavior over three months in a large , diverse sample of youths in mental health treatment and that the family-based intervention improved parental monitoring and communication with teens about sex .
CONCLUSIONS	These interventions show promise .

###25407693
BACKGROUND	Structured educational programmes for patients at risk for anaphylaxis have not yet been established .
BACKGROUND	Patients and caregivers often lack adequate skills in managing the disease .
METHODS	To investigate effects of structured patient education intervention on knowledge , emergency management skills and psychological parameters in patients with previous episodes of anaphylaxis and caregivers of affected children 95 caregivers ( 11 male , 84 female , mean age 37years ) of affected children and 98 patients ( 32 male , 66 female , mean age 47.5 years ) were randomly assigned to an intervention ( IG ) or control group ( CG ) in a multicentre randomized controlled trial .
METHODS	The IG received two 3-h schooling modules of group education ; the CG received standard auto-injector training only .
METHODS	Knowledge of anaphylaxis and emergency management competence in a validated training anaphylaxis situation as main outcome measures as well as secondary psychological parameters were assessed at baseline and 3months after intervention .
RESULTS	In comparison with controls , the intervention led to significant improvement of knowledge from baseline to 3-month follow-up ( caregivers : IG 3.2 / 13.2 improvement/baseline vs CG 0.7 / 12.6 ; P < 0.001 ; patients : IG 3.9 / 10.8 vs 1.3 / 12.6 ; P < 0.001 ) .
RESULTS	Moreover , emergency management competence was increased after intervention as compared to controls ( caregivers : IG 8.6 / 11.2 vs CG 1.2 / 10.8 ; P < 0.001 ; patients : 7.1 / 11.0 vs 1.1 / 11.1 ; P < 0.001 ) .
RESULTS	Intervention showed significant reduction of caregiver anxiety ( -1.9 / 8.4 vs -0.7 / 7.5 ; P < 0.05 ) .
RESULTS	There were no significant changes in the depression scores .
CONCLUSIONS	Structured patient education programmes may be beneficial in the management of anaphylaxis by increasing patients ' empowerment to prevent and treat the disease .

###24657803
BACKGROUND	Postoperative atrial fibrillation ( POAF ) is considered to be a transient arrhythmia in the first week after cardiac surgery .
OBJECTIVE	To determine the 30-day incidence and predictors of POAF and the value of postoperative overdrive biatrial pacing in the prevention of POAF .
METHODS	Patients ( n = 148 ) without a history of atrial fibrillation undergoing aortic valve replacement or coronary artery bypass graft ( CABG ) were randomized into a pacing group ( n = 75 ) and a control group .
METHODS	Patients were treated with standardized sotalol postoperatively .
METHODS	Rhythm was continuously monitored for 30 days by a transtelephonic event recorder .
RESULTS	POAF occurred in 73 ( 49.3 % ) patients , of whom 60 ( 40.5 % ) patients showed POAF during postoperative days ( PODs ) 0-5 and 37 ( 25 % ) patients during PODs 6-30 .
RESULTS	Prolonged aortic cross-clamp time was an important univariate predictor of 30-day and of late POAF ( PODs 6-30 ; P = .017 and P = .03 , respectively ) .
RESULTS	Best-fit model analysis using 15 predetermined risk factors for POAF showed different positive interactive effects for early POAF ( ie , baseline C-reactive protein levels with a history of myocardial infarction or low body mass index ) and late POAF ( ie , high body mass index , diabetes mellitus , baseline C-reactive protein , early POAF , creatinine levels , type of operation , smoking , and male gender ) .
RESULTS	Biatrial pacing reduced the late POAF incidence in patients with aortic cross-clamp time > 50 minutes ( P = .006 ) .
CONCLUSIONS	POAF is not limited to the first week after cardiac surgery but also occurs frequently in the postoperative month .
CONCLUSIONS	It is desirable to regularly follow patients with POAF for atrial fibrillation recurrences after discharge .

###24485847
BACKGROUND	Only about a third of patients with an episode of major depressive disorder remit with a given treatment and few remissions occur within the first weeks of treatment .
BACKGROUND	This study tested whether combining escitalopram and bupropion as initial treatment would result in quicker remission and a higher remission rate than monotherapy with either drug .
METHODS	Two hundred forty-five outpatients aged 18-65 having non-psychotic , non-bipolar major depression were randomly assigned to double-blind treatment with bupropion or escitalopram or the combination dosed to a maximum of bupropion 450 mg/d and/or escitalopram 40 mg/d for 12 weeks .
METHODS	A Montgomery-Asberg Depression Rating Scale score of 22 was required for randomization , while a Hamilton Rating Scale for Depression score 7 defined remission .
METHODS	We hypothesized that bupropion plus escitalopram would outperform both monotherapies in both earlier onset of remission and higher rate of remission .
RESULTS	Primary analyses did not demonstrate that dual therapy outperformed both monotherapies in either timing of remission or remission rate .
RESULTS	All three treatments were well tolerated .
CONCLUSIONS	These results do not support initial use of bupropion plus escitalopram to speed or enhance antidepressant response .
BACKGROUND	NCT00519428 .

###24364085
BACKGROUND	Atrial fibrillation ( AF ) often occurs after coronary artery bypass grafting ( CABG ) and can result in increased morbidity and mortality due to complications .
BACKGROUND	In the present study , our goal was to investigate whether the use of levosimendan can reduce the frequency of AF after coronary artery bypass grafting in patients with poor left ventricle function .
METHODS	To investigate the effectiveness of levosimendan in the prophylaxis of AF , we conducted a prospective , randomized , placebo-controlled clinical study on 200 consecutive patients in whom we performed elective CABG operations .
METHODS	Baseline characteristics were similar in both groups .
METHODS	A control group of 100 patients were treated with placebo ( 500 mL saline solution ) , whereas the levosimendan group ( n = 100 patients ) was treated with levosimendan .
METHODS	High-sensitivity C-reactive protein , cardiac troponin , and creatine kinaseMB levels were measured before surgery and 5 days postoperatively .
RESULTS	AF occurred in 12 % of the levosimendan group and 36 % of the control group .
RESULTS	The occurrence of AF was significantly lower in the levosimendan group ( P < 0.05 ) .
RESULTS	The duration of AF in the levosimendan group was significantly shorter than that in the control group ( 4.83 1.12 and 6.50 1.55 hours , respectively ; P = 0.028 ) .
RESULTS	Our research showed that C-reactive protein was higher postoperatively in the control group than in the levosimendan group ( P < 0.05 ) .
CONCLUSIONS	The incidence of postoperative AF in the levosimendan group was reduced significantly in patients with poor left ventricle function after CABG operations .

###25247967
OBJECTIVE	In lung cancer screening , the prevalence of chronic respiratory symptoms is high among heavy smokers .
OBJECTIVE	The purpose of this study was to compare CT-derived airway wall measurements between male smokers with and those without chronic respiratory symptoms .
METHODS	Fifty male heavy smokers with chronic respiratory symptoms ( cough , excessive mucus secretion , dyspnea , and wheezing ) and 50 without any respiratory symptom were randomly selected from the Dutch-Belgian Randomized Lung Cancer Screening Trial .
METHODS	Thin-slice low-dose CT images were evaluated with dedicated software for airway measurements .
METHODS	Wall area percentage and airway wall thickness were measured from trachea to bronchi in five different pulmonary lobes of airways with a luminal diameter of 5 mm or greater .
METHODS	Association between airway wall measurements and respiratory symptoms was analyzed by multiple linear regression adjusted for age , body mass index , smoking status , emphysema , and pulmonary function .
RESULTS	After adjustment for relevant factors , a significant positive association between airway wall measurements and respiratory symptoms was found in airways with a luminal diameter between 5 to 10 mm ( p < 0.01 ) , but not in airways measuring 10 mm or greater ( p > 0.05 ) .
RESULTS	At the airway level between 5 to 10 mm , the mean wall area percentages were 51.5 % 7.9 % .
RESULTS	Airway wall thicknesses were 1.54 0.39 mm and 1.37 0.35 mm ( p < 0.001 ) .
CONCLUSIONS	Male heavy smokers with chronic respiratory symptoms in lung cancer screening , who are at high-risk of chronic bronchitis , have bronchial wall thickening in airways with a luminal diameter of 5-10 mm but not in larger airways .

###25468164
BACKGROUND	Medical abortion with mifepristone and prostaglandins is well established .
BACKGROUND	We compared clinical assessment with self-assessment of abortion outcome .
METHODS	This randomised , controlled , non-inferiority trial was done in four clinics in Austria , Finland , Norway , and Sweden , between Aug 16 , 2011 , and Jan 31 , 2013 .
METHODS	Women aged 18 years and older who had requested medical termination of a pregnancy up to 63 days of gestation were eligible .
METHODS	Computer-generated block randomisation ( block size ten ) assigned women in a 1:1 ratio to attend routine clinical follow-up or to self-assess outcome at home with a semiquantitative urine human chorionic gonadotropin ( hCG ) test 1-3 weeks after abortion .
METHODS	The primary outcome was the percentage of women with complete abortion not requiring further medical or surgical intervention within 3 months .
METHODS	Analysis was per protocol and by intention to treat .
METHODS	The non-inferiority margin was five percentage points .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01487213 .
RESULTS	924 women were assigned routine follow-up ( n = 466 ) or self-assessment ( n = 458 ) and included in the intention-to-treat analysis .
RESULTS	901 were included in the per-protocol analysis ( n = 446 and n = 455 , respectively ) .
RESULTS	Complete abortion was reported in 432 ( 95 % ) of 455 in the routine follow-up group and 419 ( 94 % ) of 446 women in the self-assessment group ( crude difference -10 , 95 % CI -40 to 20 ) .
RESULTS	20 ( 4 % ) women in the routine follow-up group and 17 ( 4 % ) in the self-assessment group required surgery .
RESULTS	No women in the routine follow-up group versus three in the self-assessment group had undetected continuing pregnancies .
RESULTS	Eight ( 18 % ) and one ( 02 % ) women , respectively , had infections ( p = 0038 ) .
CONCLUSIONS	Self-assessment was non-inferior to routine follow-up and could save resources .
BACKGROUND	Nordic Federation of Obstetrics and Gynaecology , European Society of Contraception , Helsinki University Central Hospital , Helse Finnmark , Swedish Research Council , and Stockholm County Council and Karolinska University Hospital .

###26214039
BACKGROUND	A candidate tetravalent dengue vaccine is being assessed in three clinical trials involving more than 35,000 children between the ages of 2 and 16 years in Asian-Pacific and Latin American countries .
BACKGROUND	We report the results of long-term follow-up interim analyses and integrated efficacy analyses .
METHODS	We are assessing the incidence of hospitalization for virologically confirmed dengue as a surrogate safety end point during follow-up in years 3 to 6 of two phase 3 trials , CYD14 and CYD15 , and a phase 2b trial , CYD23/57 .
METHODS	We estimated vaccine efficacy using pooled data from the first 25 months of CYD14 and CYD15 .
RESULTS	Follow-up data were available for 10,165 of 10,275 participants ( 99 % ) in CYD14 and 19,898 of 20,869 participants ( 95 % ) in CYD15 .
RESULTS	Data were available for 3203 of the 4002 participants ( 80 % ) in the CYD23 trial included in CYD57 .
RESULTS	During year 3 in the CYD14 , CYD15 , and CYD57 trials combined , hospitalization for virologically confirmed dengue occurred in 65 of 22,177 participants in the vaccine group and 39 of 11,089 participants in the control group .
RESULTS	Pooled relative risks of hospitalization for dengue were 0.84 ( 95 % confidence interval [ CI ] , 0.56 to 1.24 ) among all participants , 1.58 ( 95 % CI , 0.83 to 3.02 ) among those under the age of 9 years , and 0.50 ( 95 % CI , 0.29 to 0.86 ) among those 9 years of age or older .
RESULTS	During year 3 , hospitalization for severe dengue , as defined by the independent data monitoring committee criteria , occurred in 18 of 22,177 participants in the vaccine group and 6 of 11,089 participants in the control group .
RESULTS	Pooled rates of efficacy for symptomatic dengue during the first 25 months were 60.3 % ( 95 % CI , 55.7 to 64.5 ) for all participants , 65.6 % ( 95 % CI , 60.7 to 69.9 ) for those 9 years of age or older , and 44.6 % ( 95 % CI , 31.6 to 55.0 ) for those younger than 9 years of age .
CONCLUSIONS	Although the unexplained higher incidence of hospitalization for dengue in year 3 among children younger than 9 years of age needs to be carefully monitored during long-term follow-up , the risk among children 2 to 16 years of age was lower in the vaccine group than in the control group .
CONCLUSIONS	( Funded by Sanofi Pasteur ; ClinicalTrials.gov numbers , NCT00842530 , NCT01983553 , NCT01373281 , and NCT01374516 . )

###25024441
BACKGROUND	With regard to clinicopathological findings and disease prognosis , breast cancer in young women is different from that in older women .
BACKGROUND	However , few studies have investigated magnetic resonance imaging ( MRI ) characteristics of young age-onset breast cancer .
OBJECTIVE	To retrospectively evaluate and compare the MR images and clinicopathological characteristics of invasive breast cancer in young women ( aged < 35 years ) with those of breast cancers in older premenopausal women ( 35-45 years ) .
METHODS	A total of 270 invasive breast cancers in 266 premenopausal women aged 45 years and younger who underwent preoperative breast MRI and curative surgery were identified between 2009 and 2013 .
METHODS	The subjects were divided into a young group ( < 35 years , n = 56 ) and an older group ( 35-45 years , n = 214 ) .
METHODS	MRI features and clinicopathological data were compared between the two groups .
RESULTS	The young group had more positive axillary lymph nodes , higher histologic grade , negative estrogen receptor ( ER ) , negative progesterone receptor ( PR ) , and higher p53 and Ki-67 expression compared to the older group .
RESULTS	Using MRI , the young group was more likely to display a round/oval or lobular mass shape , a smooth mass margin , and a high signal intensity on T2-weighted images when compared to the older group .
RESULTS	In multivariate analysis , positive axillary nodal status ( adjusted odds ratio [ OR ] , 4.070 ; P = 0.002 ) , higher expression of p53 ( adjusted OR , 2.902 ; P = 0.038 ) , lobular mass shape ( adjusted OR , 4.979 ; P = 0.028 ) , and smooth mass margin ( adjusted OR , 5.123 ; P = 0.048 ) were independently associated with the young group .
CONCLUSIONS	MR morphologic features , including lobular mass shape and smooth mass margin , were independently associated with breast cancer in young women , in addition to positive axillary nodal status and higher p53 expression status .

###24366758
OBJECTIVE	Cisplatin plus 5-fluorouracil has been globally accepted as a standard regimen for the treatment for advanced gastric cancer .
OBJECTIVE	However , cisplatin has several disadvantages , including renal toxicity and the need for admission .
OBJECTIVE	S-1 plus cisplatin has become a standard treatment for advanced gastric cancer in East Asia .
OBJECTIVE	This phase III study was designed to evaluate the potential benefits of adding docetaxel to S-1 without a platinum compound in patients with advanced gastric cancer .
METHODS	Patients were randomly assigned to receive docetaxel plus S-1 or S-1 alone .
METHODS	The docetaxel plus S-1 group received docetaxel on day 1 and oral S-1 on days 1-14 of a 21-day cycle .
METHODS	The S-1 alone group received oral S-1 on days 1-28 of a 42-day cycle .
METHODS	The primary end point was overall survival .
RESULTS	Of the 639 patients enrolled , 635 were eligible for analysis .
RESULTS	The median overall survival was 12.5 months in the docetaxel plus S-1 group and 10.8 months in the S-1 alone group ( p = 0.032 ) .
RESULTS	The median progression-free survival was 5.3 months in the docetaxel plus S-1 group and 4.2 months in the S-1 alone group ( p = 0.001 ) .
RESULTS	As for adverse events , neutropenia was more frequent in the docetaxel plus S-1 group , but remained manageable .
CONCLUSIONS	As first-line treatment for advanced gastric cancer , docetaxel plus S-1 significantly improves median overall and progression-free survival as compared with S-1 alone .
CONCLUSIONS	( ClinicalTrials.gov number : NCT00287768 ) .

###25626749
OBJECTIVE	Clinical skills expertise can be advanced through accessible and cost-effective video-based observational practice activities .
OBJECTIVE	Previous findings suggest that the observation of performances of skills that include flaws can be beneficial to trainees .
OBJECTIVE	Observing the scope of variability within a skilled movement allows learners to develop strategies to manage the potential for and consequences associated with errors .
OBJECTIVE	This study tests this observational learning approach on the development of the skills of central line insertion ( CLI ) .
METHODS	Medical trainees with no CLI experience ( n = 39 ) were randomised to three observational practice groups : a group which viewed and assessed videos of an expert performing a CLI without any errors ( F ) ; a group which viewed and assessed videos that contained a mix of flawless and errorful performances ( E ) , and a group which viewed the same videos as the E group but were also given information concerning the correctness of their assessments ( FA ) .
METHODS	All participants interacted with their observational videos each day for 4 days .
METHODS	Following this period , participants returned to the laboratory and performed a simulation-based insertion , which was assessed using a standard checklist and a global rating scale for the skill .
METHODS	These ratings served as the dependent measures for analysis .
RESULTS	The checklist analysis revealed no differences between observational learning groups ( grand mean standard error : [ 20.3 0.7 ] / 25 ) .
RESULTS	However , the global rating analysis revealed a main effect of group ( d.f. 2,36 = 4.51 , p = 0.018 ) , which describes better CLI performance in the FA group , compared with the F and E groups .
CONCLUSIONS	Observational practice that includes errors improves the global performance aspects of clinical skill learning as long as learners are given confirmation that what they are observing is errorful .
CONCLUSIONS	These findings provide a refined perspective on the optimal organisation of skill education programmes that combine physical and observational practice activities .

###25407377
OBJECTIVE	To examine the association between individual drug use and peer leaders use .
METHODS	Analysis of drug use behaviors of 525 students randomized into three arms-control , standard , and networked where peers serve as group leaders .
RESULTS	Among the combined male and female group , there was no association between peer leader and individual use .
RESULTS	Among males , peer leader use at baseline was positively associated with individual alcohol use at post-test .
RESULTS	Among females , peer leader use at post-test was negatively associated with marijuana and cigarette use .
CONCLUSIONS	Having peer leaders in the network condition decreased the odds of marijuana and cigarette use among females .
CONCLUSIONS	The opposite effect was found in males .

###24619624
OBJECTIVE	Pylorus-preserving pancreatoduodenectomy ( PPPD ) has been associated with a high incidence of delayed gastric emptying ( DGE ) .
OBJECTIVE	There are few studies comparing DGE associated with PPPD and subtotal stomach-preserving pancreatoduodenectomy ( SSPPD ) .
OBJECTIVE	Moreover , differences between the procedures with respect to long-term results have not been reported .
OBJECTIVE	A prospective randomized study was conducted to compare perioperative complications and long-term nutritional status with PPPD and SSPPD .
METHODS	One hundred patients with periampullary lesions were randomized to receive either PPPD ( n = 50 ) or SSPPD ( n = 50 ) .
METHODS	All patients were followed up for 3 years after surgery or to the time of recurrence to evaluate nutritional status for the study .
METHODS	The effects of the procedure , age , and malignancy on changes in nutritional indicators were estimated with linear mixed models .
METHODS	This study was registered at UMIN Clinical Trials Registry ( UMIN 000012337 ) .
RESULTS	The incidence of DGE assessed by the International Study Group of Pancreatic Surgery was 20 % with PPPD and 12 % with SSPPD ( P = 0.414 ) .
RESULTS	There were no significant differences between the two procedures on postoperative serum albumin levels , serum total cholesterol levels , and body mass index during the 3-year follow-up period .
CONCLUSIONS	SSPPD is equally effective in DGE occurrence rate and long-term nutritional status comparing to PPPD .

###25049137
OBJECTIVE	To evaluate the effectiveness of two subsequent intervention components ( motivational and self-regulatory components ) , placed in different order , to promote fruit and vegetable ( FV ) intake .
METHODS	After baseline assessment , university students ( N = 205 , aged 18-26 years ) were allocated to two groups .
METHODS	One group received a motivational intervention ( outcome expectancies , risk perception , and task self-efficacy ) followed by a self-regulatory intervention ( planning and dietary self-efficacy ) after 17 days .
METHODS	The second group received the same intervention conditions in the opposite order .
METHODS	Follow-up assessments were done after another 17 days .
RESULTS	Both intervention sequences yielded gains in terms of FV intake and self-efficacy .
RESULTS	However , this gain was only due to the self-regulatory component whereas the motivational component did not contribute to the changes .
RESULTS	Moreover , changes in intention and self-efficacy mediated between intervention sequence and follow-up behavior , suggesting that improving these proximal predictors of FV intake was responsible for the behavioral gains .
CONCLUSIONS	Findings highlight the superiority of a self-regulatory intervention over a motivational intervention when it comes to dietary changes in this sample of young adults .
CONCLUSIONS	Moreover , changes in dietary self-efficacy may drive nutritional changes .

###25147253
OBJECTIVE	To assess the relative impact of an intensive lifestyle intervention ( ILI ) on use and costs of health care within the Look AHEAD trial .
METHODS	A total of 5,121 overweight or obese adults with type 2 diabetes were randomly assigned to an ILI that promoted weight loss or to a comparison condition of diabetes support and education ( DSE ) .
METHODS	Use and costs of health-care services were recorded across an average of 10 years .
RESULTS	ILI led to reductions in annual hospitalizations ( 11 % , P = 0.004 ) , hospital days ( 15 % , P = 0.01 ) , and number of medications ( 6 % , P < 0.001 ) , resulting in cost savings for hospitalization ( 10 % , P = 0.04 ) and medication ( 7 % , P < 0.001 ) .
RESULTS	ILI produced a mean relative per-person 10-year cost savings of $ 5,280 ( 95 % CI 3,385-7 ,175 ) ; however , these were not evident among individuals with a history of cardiovascular disease .
CONCLUSIONS	Compared with DSE over 10 years , ILI participants had fewer hospitalizations , fewer medications , and lower health-care costs .

###24518163
OBJECTIVE	To compare tidal breathing on different continuous positive airway pressure ( CPAP ) devices and pressures and to serially measure tidal breathing during weaning off CPAP using electromagnetic inductive plethysmography .
METHODS	Using electromagnetic inductive plethysmography , tidal breathing was measured in 29 preterm infants receiving CPAP , gestational age 28 2 weeks .
METHODS	Variable-flow nasal CPAP ( nCPAP ) , bubble CPAP ( bCPAP ) at pressures of 5 , 7 , and 9 cmH2O , nasal bi-level positive airway pressure ( nBiPAP ) system at pressures of 5 , 7/5 , and 9/5 cmH2O , and unsupported breathing were studied .
METHODS	Twenty-one infants had weekly tidal breathing measurements on and off nCPAP .
RESULTS	Minute volume ( MV/kg ) was similar between all devices ( 0.30-0 .33 L/kg/min ) .
RESULTS	On bCPAP , weight corrected tidal volume ( VT/kg ) was the least , changing little with increasing pressures .
RESULTS	On nCPAP and nBiPAP , VT/kg increased with increasing pressure and the respiratory rate ( fR ) decreased .
RESULTS	The delivered pressure varied slightly from the set pressure being most dissimilar on nBiPAP and similar on bCPAP .
RESULTS	Compared with unsupported breathing , all devices decreased VT/kg , MV/kg , and phase angle , but did not alter fR .
RESULTS	Serial tidal breathing measurements showed decreasing difference for VT/kg over time on and off nCPAP .
CONCLUSIONS	At different pressure settings , on all CPAP devices the measured MV/kg was similar either through increasing VT/kg and decreasing fR ( nCPAP and nBiPAP ) or maintaining both ( bCPAP ) .
CONCLUSIONS	Serial tidal breathing measurements may aid weaning from CPAP .

###26156733
BACKGROUND	Epidemiologic data suggest that low serum 25-hydroxyvitamin D [ 25 ( OH ) D ] increases insulin resistance and the risk of type 2 diabetes .
BACKGROUND	Few interventional trials have assessed the effect of vitamin D on insulin metabolism , and published results are discordant .
OBJECTIVE	The goal of this study was to perform a detailed assessment of the effect of ergocalciferol administration on glucose and insulin metabolism in healthy people with low total 25 ( OH ) D ( total ) .
METHODS	This was a 12-wk , double-blinded , randomized controlled trial .
METHODS	We enrolled 90 healthy volunteers aged 18-45 y with serum 25 ( OH ) D 20 ng/mL ( by immunoassay ) and administered 50,000 IU ergocalciferol/wk or placebo for 12 wk .
METHODS	Primary endpoints were change in first-phase insulin response and insulin sensitivity as measured by intravenous glucose tolerance test .
METHODS	Secondary endpoints included change in homeostasis model assessment of insulin resistance ; fasting glucose , insulin , and lipids ; body mass index ( BMI ) ; and blood pressure .
RESULTS	On-study 25 ( OH ) D ( total ) was assessed by liquid chromatography-tandem mass spectrometry .
RESULTS	In the treated group , 25 ( OH ) D ( total ) rose from 18 7 to 43 12 ng/mL ( P < 0.001 ) with no change in the placebo group .
RESULTS	Despite this increase , at 12 wk , there were no between-group differences in either insulin response or insulin sensitivity ; nor were there differences in any measured secondary endpoints .
RESULTS	There was no evidence of effect modification by sex , race , glucose tolerance status , baseline 25 ( OH ) D ( total ) , or BMI .
CONCLUSIONS	In healthy persons with low 25 ( OH ) D ( total ) , ergocalciferol administration for 12 wk normalizes 25 ( OH ) D ( total ) but does not improve insulin secretion , insulin sensitivity , or other markers of metabolic health .

###25848812
BACKGROUND	The high prevalence of physical inactivity has led to a search for novel and feasible interventions that will enhance physical activity , especially among the least physically active individuals .
BACKGROUND	This randomized controlled trial aimed to determine the effectiveness of a value-based intervention to promote a physically more active lifestyle among physically inactive adults .
BACKGROUND	The framework of the study was based on Acceptance and Commitment Therapy ( ACT ) .
METHODS	Physically inactive participants aged 30 to 50years ( n = 138 ) were randomly allocated to a feedback ( FB , n = 69 ) or an acceptance - and commitment-based group ( ACT+FB , n = 69 ) .
METHODS	Both groups received written feedback about their objectively measured physical activity and were offered a body composition analysis .
METHODS	In addition , the participants in the ACT+FB group attended six group sessions and were given a pedometer for self-monitoring their physical activity during the nine-week intervention .
METHODS	The primary outcome was physical activity .
METHODS	In addition , participants ' cognitions related to exercise and physical activity were evaluated at baseline and at three - and six-month follow-ups .
METHODS	The changes in mean physical activity level were analysed using multilevel random regression and rank order stability , using the structural equation model .
RESULTS	Participants in both groups increased their objectively measured and self-reported physical activity with high individual differences .
RESULTS	No difference was observed in the change of physical activity level between the FB and ACT+FB groups over time .
RESULTS	However , the cognitions related to physical activity and exercise improved more in the ACT+FB group than in the FB group .
RESULTS	In addition , after re-analyzing the data among the non-depressive participants , higher stability was observed in objectively measured physical activity at the individual level between the three - and six-month follow-ups in the ACT+FB group as compared to FB group .
CONCLUSIONS	Acceptance - and commitment-based group intervention , combined with the self-monitoring of physical activity , was beneficial in supporting the cognition related to exercise and physical activity , and brought more stability to the individual level physical activity behaviour change , especially among the non-depressive participants .
BACKGROUND	ClinicalTrials.gov , number NCT01796990 .
BACKGROUND	Registered in February 2013 .

###24263023
BACKGROUND	We investigated cardiac proinflammatory , mitogenic , and apoptotic signaling events , and plasma biomarkers of inflammation and oxidative stress in de novo adult cardiac transplant ( CTX ) patients receiving tacrolimus ( TAC ) or cyclosporine A ( CsA ) .
METHODS	One hundred CTX recipients were randomized 1:1 to TAC/CsA in a prospective , randomized open-label multicenter study .
METHODS	Biomarkers of inflammation , immunity , oxidative stress , and cardiac signaling underlying growth and inflammation ( extracellular signal-related kinase 1/2 , p38 mitogen-activated protein kinase , mitogen-activated protein kinase kinases [ MEK ] 1/2 and 3/6 , c-Src ) , and apoptosis and survival ( c-Jun NH2-terminal kinases [ JNK ] , Bax/Bcl2 , Akt ) were assessed at 2 , 4 , 12 , 26 , and 52 weeks post-CTX .
METHODS	Plasma from healthy controls ( n = 30 ) and tissue from explanted non-failing hearts ( n = 6 ) were used as controls .
RESULTS	Biomarkers of inflammation/immunity ( interleukin -6 and -18 , soluble intercellular adhesion molecule , E-selectin , monocyte chemoattractant protein-1 , osteopontin , fibrinogen , N-terminal prohormone brain natriuretic peptide , high-sensitive C-reactive protein ) and oxidative stress ( thiobarbituric acid reactive substances , nitrotyrosine ) were increased , and antioxidant capacity was ( glutathione/glutathione disulfide ) decreased in patients vs healthy controls ( p < 0.05 ) .
RESULTS	Phosphorylation of mitogen-activated protein kinases and Akt was increased , and Bax/Bcl was decreased in transplanted vs non-transplanted hearts .
RESULTS	Except for plasma fibrinogen , which was lower in TAC vs. CsA , ( p = 0.01 ) , there were no significant differences in parameters studied between TAC vs CsA immunoprophylaxis .
CONCLUSIONS	De novo CTX recipients exhibit significant sub-clinical inflammation and oxidative stress that persists 12 months after transplantation .
CONCLUSIONS	Associated with this is activation of myocardial growth and inflammatory signaling and decreased apoptosis .
CONCLUSIONS	Our findings suggest that CTX is an inflammatory condition associated with oxidative stress and myocardial growth regardless of CsA or TAC immunoprophylaxis and independently of rejection status .

###25161021
OBJECTIVE	To test whether a prolonged 3-hour infusion of meropenem 500mg achieves an equivalent proportion of time above the minimal inhibitory concentration ( MIC ) ( % TMIC ) to that of meropenem 1000mg given over 30 minutes .
METHODS	A randomised crossover study in 10 critically ill patients .
METHODS	We administered meropenem as a 1000mg , 30-minute infusion or as a 500mg , 3-hour infusion .
METHODS	We determined serial plasma concentrations for each dosing episode and performed comparisons of % TMIC at different MICs .
METHODS	The percentage of time that meropenem was above its MIC .
RESULTS	For low MICs ( 2 mg/L ) , both regimens attained a % TMIC > 40 % in all patients .
RESULTS	For an MIC of 4mg/L , this target was attained in all but one patient , but with an MIC of 8mg/L , three patients in each group had a % TMIC < 40 % .
RESULTS	There was no difference in target attainment between the two regimens for MICs up to 8mg/L .
RESULTS	There was marked variability in the pharmacokinetic and hence the pharmacokinetic-pharmacodynamic parameters between individuals .
RESULTS	Several patients had elevated creatinine clearances and , with both regimens , their target attainment was poor .
CONCLUSIONS	Meropenem at 1000mg over 30 minutes achieved a similar % TMIC to meropenem at 500mg given over 3 hours .
CONCLUSIONS	Meropenem pharmacokinetics were highly variable from individual to individual .

###25049132
BACKGROUND	Probiotic bacteria have been shown to have various effects on the microbiota ; this may also affect appetite and may help promote weight loss and maintenance .
OBJECTIVE	This study was conducted to investigate the effect of Lactobacillus paracasei subsp paracasei L. casei W8 ( L. casei W8 ) on glucagon-like peptide-1 ( GLP-1 ) responses in an isolated pig intestine , in piglets and postprandially in humans .
OBJECTIVE	Additionally , the effect on subjective appetite , ad libitum energy intake , and glucose and insulin responses in humans was investigated .
METHODS	Piglets were fed with probiotics for 2 weeks and the effect on glucagon encoding gene ( GCG ) was investigated .
METHODS	An isolated pig intestine was perfused with L. casei W8 and the GLP-1 response was measured .
METHODS	Twenty-one subjects completed a randomized , controlled , crossover study with three arms .
METHODS	Each participant completed 3 test days testing the effect of low dose ( LD ) ( 10 ( 9 ) CFU ) , high dose ( HD ) ( 10 ( 10 ) CFU ) L. casei W8 or placebo capsule .
METHODS	Subjective appetite was assessed before an ad libitum lunch was served .
METHODS	GLP-1 , insulin and glucose concentrations were analyzed .
RESULTS	Two weeks of treatment of piglets with L. casei W8 resulted in an increase in GCG expression compared to control animals ( P < .05 ) .
RESULTS	L. casei W8 increased the GLP-1 response in the isolated pig intestine .
RESULTS	In humans , L. casei W8 had an overall effect on energy intake ( P = 0.03 ) , but no effects on subjective appetite sensation , overall glucose and insulin response and on GLP-1 release were observed ( P > 0.1 ) .
CONCLUSIONS	The probiotic bacteria L. casei W8 appears to lower food intake acutely , but the underlying mechanisms are not understood .

###25089280
OBJECTIVE	This study was designed to evaluate the role of maintenance therapy with partially hydrolyzed guar gum ( PHGG ) after topical application of glyceryl trinitrate ( GTN ) in the conservative treatment of chronic anal fissure ( CAF ) .
METHODS	From all the patients with CAF observed during the study period , 165 subjects with healed CAF after standard therapy with topical GTN 0.4 % ointment were randomized to receive ( group II ) or not ( group I ) maintenance therapy with PHGG for 10 months .
METHODS	Clinical and manometric followup was carried out 6 and 12 months after treatment .
RESULTS	At six-month followup , median visual analogue scale score was significantly higher in group I if compared with group II .
RESULTS	The success and recurrence rate at 12-month followup were , respectively , 38.3 % ( 28/73 ) in group I versus 58.5 % ( 41/70 ) in group II ( P = 0.019 ; Fisher 's exact test ) and 30.2 % ( 13/43 ) in group I versus 14.5 % ( 7/48 ) in group II ( P = 0.0047 ; Fisher 's exact test ) .
CONCLUSIONS	The maintenance therapy with PHGG in patients with healed CAF after chemical sphincterotomy by topical application of GTN 0.4 % ointment seems associated with a significant reduction of recurrence rate and with a significant increase of success rate at 12-month followup .

###25707379
OBJECTIVE	To determine the effects of an intensive lifestyle intervention versus a comparison group on body composition in obese or overweight persons with type 2 diabetes at baseline and at 1 , 4 , and 8 years .
METHODS	Body composition was measured by dual-energy X-ray absorptiometry in a subset of 1019 Look AHEAD study volunteers randomized to intervention or comparison groups .
METHODS	The intervention was designed to achieve and maintain 7 % weight loss through increased physical activity and reduced caloric intake .
METHODS	The comparison group received social support and diabetes education .
RESULTS	At 1 year , the intervention group lost fat ( 5.60.2 kg ) and lean mass ( 2.30.1 kg ) but regained fat ( 100 % ) and lost lean mass between years 1 and 8 .
RESULTS	Between baseline and year 8 , weight loss was greater in intervention versus comparison groups ( 4.00.4 vs. 2.30.4 kg ) ; comparison group weight loss was mostly lean mass ( 2.10.17 kg ) .
RESULTS	Fat mass in the intervention group was lower than that of the comparison group at all post-baseline time points .
CONCLUSIONS	Reduced fat mass may place the intervention group at a lower risk of obesity-linked sequelae , a hypothesis that can be tested by future studies of this cohort .

###24606097
BACKGROUND	Relations between fibroblast growth factor-23 ( FGF-23 ) , soluble - klotho ( s -- klotho ) , and kidney function in chronic kidney disease ( CKD ) are still unclear .
BACKGROUND	Especially the role of s -- klotho requires further study .
OBJECTIVE	Our objectives were to analyze the relation of s -- klotho to estimated glomerular filtration rate ( eGFR ) , FGF-23 , and other parameters of calcium-phosphate metabolism and to investigate the response of s -- klotho to cholecalciferol .
METHODS	Twenty-four CKD ( stage 1-5 ) patients participated in this 8-week randomized controlled trial ( vitamin D and chronic renal insufficiency ) .
METHODS	Interventions included 40 000 IU cholecalciferol or placebo weekly .
METHODS	S -- klotho was determined by ELISA with antihuman klotho antibodies 67G3 and 91F1 .
RESULTS	For all patients , s -- klotho concentrations did not differ between CKD stages .
RESULTS	When patients were subdivided based on FGF-23 concentrations , a positive association of s -- klotho with eGFR became apparent in patients with lower than median FGF-23 concentrations but not in those above median value .
RESULTS	Patients with s -- klotho below 204 pg/mL showed higher age , lower phosphate clearance , and lower bone-specific alkaline phosphatase compared with patients with higher s -- klotho .
RESULTS	Treatment with cholecalciferol significantly increased 1,25-dihydroxyvitamin D.
RESULTS	The increase of FGF-23 had only borderline significance .
RESULTS	There was no significant effect of high-dose cholecalciferol administration for 8 weeks on plasma s -- klotho .
CONCLUSIONS	CKD patients with s -- klotho below 204 pg/mL had higher age , lower phosphate clearance , and lower bone-specific alkaline phosphatase .
CONCLUSIONS	An association of s -- klotho with eGFR was observed only in the presence of close to normal , but not high , FGF-23 concentrations .
CONCLUSIONS	Cholecalciferol treatment did not change s -- klotho concentrations .

###24283768
OBJECTIVE	The purpose of this study was to evaluate a traditional herbal preparation , Jobelyn , for its effects on anemia and CD4 + T-cell counts in human immunodeficiency virus-positive ( HIV + ) patients in Nigeria .
METHODS	An open-label pilot study involving 10 confirmed ( HIV + ) patients who were not receiving antiretroviral therapy ( ARVT ) was performed , in which the patients consumed Jobelyn for 8 weeks , at a dose of 500mg twice daily .
METHODS	The pilot study was followed by a controlled trial involving 51 patients , all confirmed HIV + , where the patients with CD4 + T-cell counts below 350 cells/L were receiving ARVT .
METHODS	The eight patients with baseline CD4 + T-cell counts above 350 cells/L received Jobelyn .
METHODS	The remaining patients who all received ARVT were randomized to ARVT alone versus ARVT+J obelyn for 12 weeks .
RESULTS	Patients receiving ARVT showed a statistically significant improvement in their CD4 + T-cell counts across the 12-week study period ( p < 0.01 ) .
RESULTS	Patients receiving ARVT+J obelyn showed a faster improvement , reaching a high level of statistical significance compared to baseline already at 6 weeks ( p < 0.001 ) , and remained highly significant at 12 weeks ( p < 0.001 ) .
CONCLUSIONS	This is the first controlled study conducted to evaluate efficacy of Jobelyn on immune status in HIV + patients .
CONCLUSIONS	The data suggest that consumption of Jobelyn contributed to improved hemoglobin levels and increased CD4 + T-cell counts in Nigerian HIV + patients .
CONCLUSIONS	Further studies are needed to examine similar effects in other populations , and to elaborate on the underlying mechanisms , specifically , whether the consumption of Jobelyn supported multiple aspects of bone marrow function .

###24666560
OBJECTIVE	This study aims to evaluate the immediate effect of a global pelvic manipulation ( GPM ) technique , bilaterally applied , on low back pelvic pain in women with primary dysmenorrhea ( PD ) .
METHODS	A prospective , randomized , double-blind , controlled trial .
METHODS	Faculty of Nursing , Physiotherapy and Podiatry .
METHODS	University of Sevilla , Spain .
METHODS	The sample group included 40 women ( 30 6.10 years ) that were divided into an experimental group ( EG ) ( N = 20 ) who underwent a bilateral GPM technique and a control group ( CG ) ( N = 20 ) who underwent a sham ( placebo ) intervention .
METHODS	Evaluations were made of self-reported low back pelvic pain ( visual analog scale ) , pressure pain threshold ( PPT ) in sacroiliac joints ( SIJs ) , and the endogenous response of the organism to pain following catecholamines and serotonin release in blood levels .
RESULTS	The intragroup comparison showed a significant improvement in the EG in the self-perceived low back pelvic pain ( P = 0.003 ) and in the mechanosensitivity in both SIJs ( P = 0.001 ) .
RESULTS	In the between-group comparison , there was a decrease in pain perception ( P = 0.004 ; F ( 1,38 ) = 9.62 ; R ( 2 ) = 0.20 ) and an increase in the PPT of both SIJs , in the right side ( P = 0.001 ; F ( 1,38 ) = 21.29 ; R ( 2 ) = 0.35 ) and in the left side ( P = 0.001 ; F ( 1,38 ) = 20.63 ; R ( 2 ) = 0.35 ) .
RESULTS	There were no intergroup differences for catecholamines plasma levels ( adrenaline P = 0.123 ; noradrenaline P = 0.281 ; dopamine P = 0.173 ) , but there were for serotonin levels ( P = 0.045 ; F ( 1,38 ) = 4.296 ; R ( 2 ) = 0.10 ) .
CONCLUSIONS	The bilateral GPM technique improves in a short term the self-perceived low back pelvic pain , the PPT in both SIJs , and the serotonin levels in women with PD .
CONCLUSIONS	It shows no significant differences with a sham intervention in catecholamines plasma levels .

###24412895
OBJECTIVE	To investigate whether a treat-to-target strategy with methotrexate and intra-articular glucocorticosteroid injections suppresses MRI inflammation and halts structural damage progression in patients with early rheumatoid arthritis ( ERA ) , and whether adalimumab provides an additional effect .
METHODS	In a double-blind , placebo-controlled trial , 85 disease-modifying antirheumatic drug-nave patients with ERA were randomised to receive methotrexate , intra-articular glucocorticosteroid injections and placebo/adalimumab ( 43/42 ) .
METHODS	Contrast-enhanced MRI of the right hand was performed at months 0 , 6 and 12 .
METHODS	Synovitis , osteitis , tenosynovitis , MRI bone erosion and joint space narrowing ( JSN ) were scored with validated methods .
METHODS	Dynamic contrast-enhanced MRI ( DCE-MRI ) was carried out in 14 patients .
RESULTS	Synovitis , osteitis and tenosynovitis scores decreased highly significantly ( p < 0.0001 ) during the 12-months ' follow-up , with mean change scores of -3.7 ( median -3.0 ) , -2.2 ( -1 ) and -5.3 ( -4.0 ) , respectively .
RESULTS	No overall change in MRI bone erosion and JSN scores was seen , with change scores of 0.1 ( 0 ) and 0.2 ( 0 ) .
RESULTS	The tenosynovitis score at month 6 was significantly lower in the adalimumab group , 1.3 ( 0 ) , than in the placebo group , 3.9 ( 2 ) , Mann-Whitney : p < 0.035 .
RESULTS	Furthermore , the osteitis score decreased significantly during the 12-months ' follow-up in the adalimumab group , but not in the placebo group , Wilcoxon : p = 0.001-0 .002 and p = 0.062-0 .146 .
RESULTS	DCE-MRI parameters correlated closely with conventional MRI inflammatory parameters .
RESULTS	Clinical measures decreased highly significantly during follow-up .
CONCLUSIONS	A treat-to-target strategy with methotrexate and intra-articular glucocorticosteroid in patients with ERA effectively decreased synovitis , osteitis and tenosynovitis and halted structural damage progression as judged by MRI .
CONCLUSIONS	The findings suggest that addition of adalimumab is associated with further suppression of osteitis and tenosynovitis .

###24704942
OBJECTIVE	This report describes the result of prospective randomized trial to assess effectiveness and safety of neoadjuvant photodynamic therapy ( PDT ) and chemotherapy as well as possibility for further surgery for locally advanced NSCLC .
METHODS	Patients with stage IIIA and IIIB central NSCLC ( main bronchus/distal trachea involvement ) who were not initially eligible for surgery but might be considered as surgery candidates after neoadjuvant therapy were enrolled in the study .
METHODS	They were randomized to either neoadjuvant chemotherapy and endobronchial PDT or chemotherapy alone followed by surgical resection .
METHODS	PDT was done with photosensitizer agent chlorine E6 and 662nm laser light before each of the three courses of chemotherapy .
RESULTS	From January 2008 to December 2011 , 42 patients were assigned to PDT arm ( n = 21 ) and No-PDT arm ( n = 21 ) .
RESULTS	Groups were similar with respect to age , sex , tumor stage , and histology .
RESULTS	No PDT major complications were observed .
RESULTS	After neoadjuvant treatment partial response revealed in 19pts ( 90 % ) in PDT arm and 16pts ( 76 % ) in No-PDT arm ( p = 0.460 ) , these patients underwent thoracotomy .
RESULTS	After thoracotomy tumor was unresectable in 3pts of No-PDT arm ( 19 % ) .
RESULTS	There were 14 pneumonectomies and 5 lobectomies in PDT arm vs. 10 pneumonectomies and 3 lobectomies in No-PDT arm .
RESULTS	Completeness of resection was significantly higher in PDT arm ( R0-89 % , R1-11 % ) vs. No-PDT arm ( R0-54 % , R1-46 % ) , p = 0.038 .
CONCLUSIONS	The study demonstrated that neoadjuvant PDT along with chemotherapy is effective , safe and it makes possible to convert to surgery candidates and to improve resection completeness in stage III central NSCLC patients .

###25208859
OBJECTIVE	To determine the safety and efficacy of low-voltage , external-beam , stereotactic radiotherapy ( SRT ) for patients with neovascular age-related macular degeneration ( AMD ) .
METHODS	Randomized , double-masked , sham-controlled , multicenter , clinical trial .
METHODS	A total of 230 participants with neovascular AMD who received 3 ranibizumab or bevacizumab injections within the preceding year and requiring treatment at enrollment .
METHODS	Participants received 16 Gray , 24 Gray , or sham SRT .
METHODS	All arms received pro re nata ( PRN ) ranibizumab for 12 months , with PRN bevacizumab or ranibizumab thereafter .
METHODS	Mean number of PRN injections ; best-corrected visual acuity ( BCVA ) ; loss of < 15 Early Treatment of Diabetic Retinopathy Study letters ; change in optical coherence tomography central subfield thickness ; and change in angiographic total lesion area and choroidal neovascularization ( CNV ) area .
RESULTS	At year 2 , the 16 and 24 Gray arms received fewer PRN treatments compared with sham ( mean 4.5 , P = 0.008 ; mean 5.4 , P = 0.09 ; and mean 6.6 , respectively ) .
RESULTS	Change in mean BCVA was -10.0 , -7.5 , and -6.7 letters for the 16 Gray , 24 Gray , and sham arms , respectively , with 46 ( 68 % ) , 51 ( 75 % ) , and 58 participants ( 79 % ) , respectively , losing < 15 letters .
RESULTS	Mean central subfield thickness decreased by 67.0 m , 55.4 m , and 33.3 m , respectively .
RESULTS	Mean total active lesion area increased by 1.0 , 4.2 , and 2.7 mm ( 2 ) , respectively .
RESULTS	Mean CNV area decreased by 0.1 mm ( 2 ) in all groups .
RESULTS	An independent reading center detected microvascular abnormalities in 6 control eyes and 29 SRT eyes , of which 18 were attributed to radiation ; however , only 2 of these possibly affected vision .
RESULTS	An exploratory subgroup analysis found that lesions with a greatest linear dimension 4 mm ( the size of the treatment zone ) and a macular volume greater than the median ( 7.4 mm ( 3 ) ) were more responsive to SRT , with 3.9 PRN injections versus 7.1 in comparable sham-treated participants ( P = 0.001 ) and mean BCVA 4.4 letters superior to sham ( P = 0.24 ) .
CONCLUSIONS	A single dose of SRT significantly reduces intravitreal injections over 2 years .
CONCLUSIONS	Radiation can induce microvascular change , but in only 1 % of eyes does this possibly affect vision .
CONCLUSIONS	The best response occurs when AMD lesions fit within the treatment zone and they are actively leaking .

###25011730
BACKGROUND	UK National Institute of Health and Clinical Excellence guidelines for obsessive compulsive disorder ( OCD ) specify recommendations for the treatment and management of OCD using a stepped care approach .
BACKGROUND	Steps three to six of this model recommend treatment options for people with OCD that range from low-intensity guided self-help ( GSH ) to more intensive psychological and pharmacological interventions .
BACKGROUND	Cognitive behavioural therapy ( CBT ) , including exposure and response prevention , is the recommended psychological treatment .
BACKGROUND	However , whilst there is some preliminary evidence that self-managed therapy packages for OCD can be effective , a more robust evidence base of their clinical and cost effectiveness and acceptability is required .
METHODS	Our proposed study will test two different self-help treatments for OCD : 1 ) computerised CBT ( cCBT ) using OCFighter , an internet-delivered OCD treatment package ; and 2 ) GSH using a book .
METHODS	Both treatments will be accompanied by email or telephone support from a mental health professional .
METHODS	We will evaluate the effectiveness , cost and patient and health professional acceptability of the treatments .
CONCLUSIONS	This study will provide more robust evidence of efficacy , cost effectiveness and acceptability of self-help treatments for OCD .
CONCLUSIONS	If cCBT and/or GSH prove effective , it will provide additional , more accessible treatment options for people with OCD .
BACKGROUND	Current Controlled Trials : ISRCTN73535163 .
BACKGROUND	Date of registration : 5 April 2011 .

###25431429
BACKGROUND	The PRODIGY trial ( Prevention of long term social disability amongst young people with emerging psychological difficulties , ISRCTN47998710 ) is a pilot trial of social recovery cognitive-behavioural therapy ( SRCBT ) .
OBJECTIVE	The PRODIGY qualitative substudy aimed to ( a ) explore individual experiences of participating in the pilot randomised , controlled trial ( recruitment , randomisation , assessment ) and initial views of therapy , and ( b ) to explore perceived benefits of taking part in research v. ethical concerns and potential risks .
METHODS	Qualitative investigation using semi-structured interviews with thematic analysis .
RESULTS	Analysis revealed participant experiences around the key themes of acceptability , disclosure , practicalities , altruism and engagement .
CONCLUSIONS	Participants in both trial arms perceived themselves as gaining benefits from being involved in the study , above and beyond the intervention .
CONCLUSIONS	This has implications for the design of future research and services for this client group , highlighting the importance of being flexible and an individualised approach as key engagement tools .

###24332933
OBJECTIVE	The purpose of this study was to test causal effects of physicians ' nonverbal involvement on medical error disclosure outcomes .
METHODS	216 hospital outpatients were randomly assigned to two experimental treatment groups .
METHODS	The first group watched a video vignette of a verbally effective and nonverbally involved error disclosure .
METHODS	The second group was exposed to a verbally effective but nonverbally uninvolved error disclosure .
METHODS	All patients responded to seven outcome measures .
RESULTS	Patients in the nonverbally uninvolved error disclosure treatment group perceived the physician 's apology as less sincere and remorseful compared to patients in the involved disclosure group .
RESULTS	They also rated the implications of the error as more severe , were more likely to ascribe fault to the physician , and indicated a higher intent to change doctors after the disclosure .
CONCLUSIONS	The results of this study imply that nonverbal involvement during medical error disclosures facilitates more accurate patient understanding and assessment of the medical error and its consequences on their health and quality of life .
CONCLUSIONS	In the context of disclosing medical errors , nonverbal involvement increases the likelihood that physicians will be able to continue caring for their patient .
CONCLUSIONS	Thus , providers are advised to consider adopting this communication skill into their medical practice .

###25618969
OBJECTIVE	To study changes in the nuclear factor-B p65 ( NF-B p65 ) - inducible nitric oxide synthase ( iNOS ) - nitric oxide ( NO ) signaling pathway and the effects of Xinfeng capsules ( XFC ) in patients with ankylosing spondylitis ( AS ) .
METHODS	One hundred twenty patients with AS were randomly divided into an XFC group and a Salazopyrin group .
METHODS	Sixty health subjects were included as a normal control group .
METHODS	In the two treatment groups , pulmonary functional parameters , forced vital capacity ( FVC ) , forced expiratory volume in 1 second ( FEV1 ) , maximal voluntary ventilation ( MVV ) , peak expiratory flow ( PEF ) , forced expiratory flow at 25 % of forced vital capacity ( FEF25 ) , forced expiratory flow at 50 % of forced vital capacity ( FEF50 ) , and forced expiratory flow at 75 % of forced vital capacity ( FEF75 ) were determined .
METHODS	Enzyme linked immunosorbent assays were used for detection of the serum oxidative stress indexes , NF-B p65 , iNOS , NO , reactive oxygen species ( ROS ) , reactive nitrogen species ( RNS ) , malondialdehyde ( MDA ) , superoxide dismutase ( SOD ) , catalase ( CAT ) , total antioxidative capacity ( TAOC ) and interleukin-4 ( IL-4 ) , IL-10 , IL-1 , and tumor necrosis factor - ( TNF - ) contents .
METHODS	Westergren 's method was used for determination of erythrocyte sedimentation rate ( ESR ) .
METHODS	High-sensitivity C-reactive protein ( Hs-CRP ) was detected with a 7060 full-automatic biochemical analyzer ( Hitachi , Japan ) .
RESULTS	The clinical therapeutic effect in the XFC group was significantly superior to that in the Salazopyrin group ( P < 0.01 ) .
RESULTS	Compared with the normal control group , FEV1 , MVV , PEF , FEF50 , FEF75 , SOD , CAT , TAOC , IL-4 , IL-10 were significantly lower , and NF-B p65 , iNOS , NO , ROS , RNS , MDA , IL-1 , TNF - , ESR , and Hs-CRP significantly higher in patients with AS ( P < 0.01 or P < 0.05 ) .
RESULTS	Compared with before treatment , FEV1 , MVV , PEF , FEF50 , FEF75 , SOD , CAT , TAOC , IL-4 , and IL-10 were significantly increased , and NF-B p65 , iNOS , NO , ROS , RNS , MDA , IL-1 , TNF - , ESR , CRP , visual analog scales ( VAS ) , Bath ankylosing spondylitis disease active index , Bath ankylosing spondylitis functional index , and Bath ankylosing spondylitis global index significantly decreased in the two treatment groups after treatment ( P < .
RESULTS	0.01 or P < 0.05 ) , with significant differences between the XFC and Salazopyrin groups ( P < 0.01 or P < 0.05 ) .
RESULTS	Spearman correlation analysis indicated that FEV1 , MWVV , PEF , FEF50 , and FEF75 were positively correlated with SOD , CAT , TAOC , IL-4 , and IL-10 , and were negatively correlated with NF-B p65 , iNOS , NO , ROS , RNS , MDA , IL-13 , TNF - , ESR , and CRP .
CONCLUSIONS	Patients with AS have local pathologic changes in the spinal cord and other joints .
CONCLUSIONS	They also have decreased pulmonary function , which is negatively correlated with the NF-B-iNOS-NO signaling pathway , oxidative indexes , and inflammatory factors .
CONCLUSIONS	XFC improves rigidity and pain in spinal joints and other symptoms , laboratory indexes , and pulmonary function .
CONCLUSIONS	The mechanism is possibly related to inhibition of the NF-KB-iNOS-NO signaling pathway .

###25324317
OBJECTIVE	To describe the health-related quality of life ( HRQOL ) burden of cervical dystonia ( CD ) and report on the HRQOL and patient perception of treatment benefits of abobotulinumtoxinA ( Dysport ) .
METHODS	The safety and efficacy of a single injection of abobotulinumtoxinA for CD treatment were evaluated in a previously reported international , multicenter , double-blind , randomised trial .
METHODS	HRQOL measures were assessed in the trial and have not been previously reported .
METHODS	Movement disorder clinics in the USA and Russia .
METHODS	Patients had to have a diagnosis of CD with symptoms for at least 18months , as well as a total Toronto Western Spasmodic Torticollis Rating Scale ( TWSTRS ) score of at least 30 ; a Severity domain score of at least 15 ; and a Disability domain score of at least 3 .
METHODS	Key exclusion criteria included treatment with botulinum toxin type A ( BoNT-A ) or botulinum toxin type B ( BoNT-B ) within 16weeks of enrolment .
METHODS	Patients were randomised to receive either 500 U abobotulinumtoxinA ( n = 55 ) or placebo ( n = 61 ) .
METHODS	Efficacy assessments included TWSTRS total ( primary end point ) and subscale scores at weeks 0 , 4 , 8 , 12 ; a pain visual analogue scale at weeks 0 and 4 ; and HRQOL assessed by the SF-36 Health Survey ( SF-36 ; secondary end point ) at weeks 0 and 8 .
RESULTS	Patients with CD reported significantly greater impairment for all SF-36 domains relative to US norms .
RESULTS	Patients treated with abobotulinumtoxinA reported significantly greater improvements in Physical Functioning , Role Physical , Bodily Pain , General Health and Role Emotional domains than placebo patients ( p0 .03 for all ) .
RESULTS	The TWSTRS was significantly correlated with Physical Functioning , Role Physical and Bodily Pain scores , for those on active treatment .
CONCLUSIONS	CD has a marked impact on HRQOL .
CONCLUSIONS	Treatment with a single abobotulinumtoxinA injection results in significant improvement in patients ' HRQOL .
BACKGROUND	The trial is registered at ClinicalTrials.gov , numbers NCT00257660 and NCT00288509 .

###25124998
BACKGROUND	The prognostic utility of circulating plasma microRNA in patients with acute coronary syndromes ( ACS ) has been proposed but not yet demonstrated .
BACKGROUND	We set out to investigate circulating microRNA levels in patients incurring recent ACS and examined associations with neurohormones , cardiac structure and function , and survival over 5 years of follow-up .
METHODS	An initial screen of 375 microRNAs was performed in 35 ACS patients and 16 healthy controls .
METHODS	Candidates identified from the initial screen ( miR-323-3p , miR-652 , miR-27b , miR-103 and miR-208a ) were validated in a further cohort of 200 patients at baseline ( ~ 30 days post-ACS ) and at 4 and 12 months post-ACS , and compared with 100 controls .
RESULTS	In the validation cohort , significantly higher levels in patients were replicated for miR-323-3p , miR-652 and miR-27b ( 10-fold , 2.3-fold and 2.3-fold , respectively , adjusted p < 0.05 ) .
RESULTS	Lower levels of miR-103 were not replicated and miR-208a was undetectable .
RESULTS	From baseline to 4 months post-admission , miR-323-3p and miR-652 remained elevated in patients compared to controls ( adjusted p < 0.01 ) , with no further change in levels between 4 and 12 months ; whereas miR-27b fell to control levels by 4 months .
RESULTS	Baseline levels of miR-652 in the lowest tertile were significantly associated with readmission for heart failure ( log-rank p < 0.001 ) .
RESULTS	In combination with NT-proBNP and LVEF , miR-652 significantly improved risk stratification ( p < 0.001 ) .
CONCLUSIONS	Our study identifies miR-652 as a novel candidate biomarker for post-ACS prognosis beyond existing biomarkers of LVEF and NT-proBNP .
CONCLUSIONS	Moreover circulating miR-323-3p was markedly elevated in patients for at least a year post-ACS and may be a stable biomarker for ACS .

###24713049
BACKGROUND	Prolonged ventilation and failed extubation are associated with increased harm and cost .
BACKGROUND	The added value of heart and respiratory rate variability ( HRV and RRV ) during spontaneous breathing trials ( SBTs ) to predict extubation failure remains unknown .
METHODS	We enrolled 721 patients in a multicenter ( 12 sites ) , prospective , observational study , evaluating clinical estimates of risk of extubation failure , physiologic measures recorded during SBTs , HRV and RRV recorded before and during the last SBT prior to extubation , and extubation outcomes .
METHODS	We excluded 287 patients because of protocol or technical violations , or poor data quality .
METHODS	Measures of variability ( 97 HRV , 82 RRV ) were calculated from electrocardiogram and capnography waveforms followed by automated cleaning and variability analysis using Continuous Individualized Multiorgan Variability Analysis ( CIMVA ) software .
METHODS	Repeated randomized subsampling with training , validation , and testing were used to derive and compare predictive models .
RESULTS	Of 434 patients with high-quality data , 51 ( 12 % ) failed extubation .
RESULTS	Two HRV and eight RRV measures showed statistically significant association with extubation failure ( P < 0.0041 , 5 % false discovery rate ) .
RESULTS	An ensemble average of five univariate logistic regression models using RRV during SBT , yielding a probability of extubation failure ( called WAVE score ) , demonstrated optimal predictive capacity .
RESULTS	With repeated random subsampling and testing , the model showed mean receiver operating characteristic area under the curve ( ROC AUC ) of 0.69 , higher than heart rate ( 0.51 ) , rapid shallow breathing index ( RBSI ; 0.61 ) and respiratory rate ( 0.63 ) .
RESULTS	After deriving a WAVE model based on all data , training-set performance demonstrated that the model increased its predictive power when applied to patients conventionally considered high risk : a WAVE score > 0.5 in patients with RSBI > 105 and perceived high risk of failure yielded a fold increase in risk of extubation failure of 3.0 ( 95 % confidence interval ( CI ) 1.2 to 5.2 ) and 3.5 ( 95 % CI 1.9 to 5.4 ) , respectively .
CONCLUSIONS	Altered HRV and RRV ( during the SBT prior to extubation ) are significantly associated with extubation failure .
CONCLUSIONS	A predictive model using RRV during the last SBT provided optimal accuracy of prediction in all patients , with improved accuracy when combined with clinical impression or RSBI .
CONCLUSIONS	This model requires a validation cohort to evaluate accuracy and generalizability .
BACKGROUND	ClinicalTrials.gov NCT01237886 .
BACKGROUND	Registered 13 October 2010 .

###25377067
BACKGROUND	Electroencephalographic ( EEG ) status epilepticus is described in 10 to 35 % of patients with postanoxic encephalopathy after successful cardiopulmonary resuscitation and is associated with case fatality rates of 90 to 100 % .
BACKGROUND	It is unclear whether these EEG patterns represent a condition to be treated with anticonvulsants to improve outcome , or an expression of severe ischemic damage , in which treatment is futile .
METHODS	TELSTAR is a multicenter clinical trial with two parallel groups , randomized treatment allocation , open label treatment , and blinded endpoint evaluation ( PROBE design ) .
METHODS	We aim to enroll 172 adult patients with postanoxic encephalopathy and electroencephalographic status epilepticus after successful cardiopulmonary resuscitation , admitted to the ICU , in whom continuous EEG monitoring is started within 24 hours after admission .
METHODS	Patients are randomly assigned to either medical treatment to suppress all electrographic seizure activity , or no treatment of electroencephalographic status epilepticus .
METHODS	Antiepileptic treatment is based on guidelines for treatment of overt status epilepticus and is started within 3 hours after the diagnosis .
METHODS	If status epilepticus returns during tapering of sedative medication after suppression of all epileptiform activity for 2 24 hours , it will be considered refractory .
METHODS	The primary outcome measure is neurological outcome defined as the Cerebral Performance Category ( CPC ) score at 3 months , dichotomized into ` good ' ( CPC 1 to 2 = no or moderate neurological disability ) and ` poor ' ( CPC 3 to 5 = severe disability , coma , or death ) .
METHODS	Secondary outcome measures include mortality and , for patients surviving up to 12 months , cognitive functioning , health related quality of life , and depression .
BACKGROUND	Clinicaltrials.gov ; NCT02056236 .
BACKGROUND	Date of registration : 4 February 2014 .

###24451619
OBJECTIVE	The influence of variations in exercise mode , thermal state , and load carriage on cardiac and ventilatory predictors of metabolic rate were investigated .
METHODS	Fifteen males were studied at rest and during whole - , upper - , and lower-body exercise ( unloaded and loaded ) under thermoneutral and hot conditions .
RESULTS	Ventilatory predictions were superior in thermoneutral ( residual mean square error range : 0.04 to 0.17 Lmin ( -1 ) vs 0.21 to 0.36 Lmin ( -1 ) ) and hot conditions ( 0.03 to 0.07 Lmin ( -1 ) vs 0.21 to 0.24 Lmin ( -1 ) ) .
RESULTS	Predictions derived from whole - or lower-body exercise , and unloaded or loaded exercise could be interchanged without significant error .
RESULTS	Nevertheless , a mode-specific prediction was required for upper-body work , and mild hyperthermia significantly reduced the precision of cardiac predictions .
CONCLUSIONS	Ventilatory predictions were more precise , but errors from heart-rate predictions could be minimized by using thermal-state and exercise mode-specific predictions .

###24987174
OBJECTIVE	Long standing mitral valve disease is usually associated with severe pulmonary hypertension .
OBJECTIVE	Perioperative pulmonary hypertension is a risk factor for right ventricular ( RV ) failure and a cause for morbidity and mortality in patients undergoing mitral valve replacement .
OBJECTIVE	Phosphodiesterase 5 inhibitor-sildenafil citrate is widely used to treat primary pulmonary hypertension .
OBJECTIVE	There is a lack of evidence of effects of oral sildenafil on secondary pulmonary hypertension due to mitral valve disease .
OBJECTIVE	The study aims to assess the effectiveness of preoperative oral sildenafil on severe pulmonary hypertension and incidence of RV failure in patients undergoing mitral valve replacement surgery .
METHODS	A total of 40 patients scheduled for mitral valve replacement with severe pulmonary hypertension ( RV systolic pressure ( RVSP ) 60 mmHg ) on preoperative transthoracic echo were randomly treated with oral sildenafil 25 mg ( N = 20 ) or placebo ( N = 20 ) eight hourly for 24 h before surgery .
METHODS	Hemodynamic variables were measured 20 min after insertion of pulmonary artery catheter ( PAC ) under anesthesia ( T1 ) , 20 min at weaning from cardiopulmonary bypass ( CPB ) ( T2 ) and after 1,2 , and 6 h ( T3 , T4 , T5 , respectively ) during the postoperative period .
RESULTS	Systolic and mean pulmonary artery pressure ( MPAP ) and pulmonary vascular resistance index ( PVRI ) were significantly lower ( P < 0.0001 ) in sildenafil group at all times .
RESULTS	Ventilation time and postoperative recovery room stay were significantly lower ( P < 0.001 ) in sildenafil group .
CONCLUSIONS	Sildenafil produces significant pulmonary vasodilatory effect as compared with placebo in mitral valve replacement patients with severe pulmonary hypertension .
CONCLUSIONS	It also reduces ventilation time and intensive care unit ( ICU ) stay time as compared with placebo .
CONCLUSIONS	It is concluded that sildenafil is effective in reducing pulmonary hypertension when administered preoperatively in patients with severe pulmonary hypertension undergoing mitral valve replacement surgery .

###24388737
BACKGROUND	Breech presentation occurs in up to 3 % of pregnancies at term and may be an indication for caesarean delivery .
BACKGROUND	External cephalic version can be effective in repositioning the fetus in a cephalic presentation , but may be painful for the mother .
BACKGROUND	Our aim was to assess the efficacy of remifentanil versus placebo for pain relief during external cephalic version .
METHODS	A randomized , double-blind , controlled trial that included women at 36-41 weeks of gestation with non-cephalic presentations was performed .
METHODS	Women were randomized to receive either a remifentanil infusion at 0.1 g/kg/min and demand boluses of 0.1 g/kg , or saline placebo .
METHODS	The primary outcome was the numerical rating pain score ( 0-10 ) after external cephalic version .
RESULTS	Sixty women were recruited , 29 in the control group and 31 in the remifentanil group .
RESULTS	There were significant differences in pain scores at the end of the procedure ( control 6.5 2.4 vs. remifentanil 4.7 2.5 , P = 0.005 ) but not 10 min later ( P = 0.054 ) .
RESULTS	The overall success rate for external cephalic version was 49 % with no significant differences between groups ( remifentanil group 54.8 % vs. control group 41.3 % , P = 0.358 ) .
RESULTS	In the remifentanil group , there was one case of nausea and vomiting , one of drowsiness and three cases of fetal bradycardia .
RESULTS	In the control group , there were three cases of nausea and vomiting , one of dizziness and nine cases of fetal bradycardia .
CONCLUSIONS	Intravenous remifentanil with bolus doses on demand during external cephalic version achieved a reduction in pain and increased maternal satisfaction .
CONCLUSIONS	There were no additional adverse effects , and no difference in the success rate of external cephalic version or the incidence of fetal bradycardia .

###25227543
BACKGROUND	People with stroke excessively move their trunk , when reaching and grasping objects .
OBJECTIVE	To determine if the addition of trunk restraint to modified constraint-induced movement therapy ( mCIMT ) was better than mCIMT alone in improving strength , function , and quality of life after stroke .
METHODS	A pilot randomized double-blinded clinical trial was conducted .
METHODS	Twenty-two participants with chronic stroke were randomly assigned to an experimental group that received mCIMT plus trunk restraint , or a control group ( only mCIMT ) .
METHODS	Primary outcomes were the amount of use and quality of movement of the paretic upper limb ( UL ) , determined by the Motor Activity Log ( MAL ) scores .
METHODS	Secondary outcomes included the observed performance of the paretic UL during unimanual and bimanual tasks , kinematics of reaching , strength , and quality of life .
RESULTS	Both groups demonstrated significant improvements in the MAL scores and in the time to perform bimanual activities immediately after the interventions .
RESULTS	However , no between-group differences were observed .
CONCLUSIONS	The addition of trunk restraint to mCIMT resulted in no additional benefits , compared with mCIMT alone with stroke individuals with mild to moderate impairments .
CONCLUSIONS	Unimanual and bimanual improvements were observed after mCIMT , regardless of trunk restraint , and the intervention did not adversely affect their reaching patterns .

###24308845
OBJECTIVE	Theory-based interventions to promote physical activity ( PA ) are more effective than atheoretical approaches ; however , the comparative utility of theoretical models is rarely tested in longitudinal designs with multiple time points .
OBJECTIVE	Further , there is limited research that has simultaneously tested social-cognitive models with self-report and objective PA measures .
OBJECTIVE	The primary aim of this study was to test the predictive ability of three theoretical models ( social cognitive theory , theory of planned behaviour , and protection motivation theory ) in explaining PA behaviour .
METHODS	Participants were adults with type 2 diabetes ( n = 287 , 53.8 % males , mean age = 61.6 11.8 years ) .
METHODS	Theoretical constructs across the three theories were tested to prospectively predict PA behaviour ( objective and self-report ) across three 6-month time intervals ( baseline-6 , 6-12 , 12-18 months ) using structural equation modelling .
METHODS	PA outcomes were steps/3 days ( objective ) and minutes of MET-weighted PA/week ( self-report ) .
RESULTS	The mean proportion of variance in PA explained by these models was 6.5 % for objective PA and 8.8 % for self-report PA. .
RESULTS	Direct pathways to PA outcomes were stronger for self-report compared with objective PA. .
CONCLUSIONS	These theories explained a small proportion of the variance in longitudinal PA studies .
CONCLUSIONS	Theory development to guide interventions for increasing and maintaining PA in adults with type 2 diabetes requires further research with objective measures .
CONCLUSIONS	Theory integration across social-cognitive models and the inclusion of ecological levels are recommended to further explain PA behaviour change in this population .
CONCLUSIONS	Statement of contribution What is already known on this subject ?
CONCLUSIONS	Social-cognitive theories are able to explain partial variance for physical activity ( PA ) behaviour .
CONCLUSIONS	What does this study add ?
CONCLUSIONS	The testing of three theories in a longitudinal design over 3 , 6-month time intervals .
CONCLUSIONS	The parallel use and comparison of both objective and self-report PA measures in testing these theories .

###24663961
BACKGROUND	Monitoring implementation of the `` test and treat '' case-management policy for malaria is an important component of all malaria control programmes in Africa .
BACKGROUND	Unfortunately , routine information systems are commonly deficient to provide necessary information .
BACKGROUND	Using health facility surveys we monitored health systems readiness and malaria case-management practices prior to and following implementation of the 2010 `` test and treat '' policy in Kenya .
RESULTS	Between 2010 and 2013 six national , cross-sectional , health facility surveys were undertaken .
RESULTS	The number of facilities assessed ranged between 172 and 176 , health workers interviewed between 216 and 237 and outpatient consultations for febrile patients evaluated between 1,208 and 2,408 across six surveys .
RESULTS	Comparing baseline and the last survey results , all readiness indicators showed significant ( p < 0.005 ) improvements : availability of parasitological diagnosis ( 55.2 % to 90.7 % ) ; RDT availability ( 7.5 % to 69.8 % ) ; total artemether-lumefantrine ( AL ) stock-out ( 27.2 % to 7.0 % ) ; stock-out of one or more AL packs ( 59.5 % to 21.6 % ) ; training coverage ( 0 to 50.2 % ) ; guidelines access ( 0 to 58.1 % ) and supervision ( 17.9 % to 30.8 % ) .
RESULTS	Testing increased by 34.0 % ( 23.9 % to 57.9 % ; p < 0.001 ) while testing and treatment according to test result increased by 34.2 % ( 15.7 % to 49.9 % ; p < 0.001 ) .
RESULTS	Treatment adherence for test positive patients improved from 83.3 % to 90.3 % ( p = 0.138 ) and for test negative patients from 47.9 % to 83.4 % ( p < 0.001 ) .
RESULTS	Significant testing and treatment improvements were observed in children and adults .
RESULTS	There was no difference in practices with respect to the type and result of malaria test ( RDT vs microscopy ) .
RESULTS	Of eight dosing , dispensing and counseling tasks , improvements were observed for four tasks .
RESULTS	Overall AL use for febrile patients decreased from 63.5 % to 35.6 % ( p < 0.001 ) .
CONCLUSIONS	Major improvements in the implementation of `` test and treat '' policy were observed in Kenya .
CONCLUSIONS	Some gaps towards universal targets still remained .
CONCLUSIONS	Other countries facing similar needs and challenges may consider health facility surveys to monitor malaria case-management .

###24423186
OBJECTIVE	The aim of the study was to evaluate the effectiveness of intravenous iron versus placebo added to standard oral iron therapy in the treatment of severe postpartum anaemia .
METHODS	A randomised , double-blind , parallel-group , placebo-controlled clinical trial was performed in a single centre .
METHODS	Hospital Clinic of Barcelona , Barcelona , Spain .
METHODS	A cohort of 72 women with severe postpartum anaemia ( 6.0-8 .0 g/dl ) treated with oral ferrous sulphate ( two tablets of 525mg ) .
METHODS	Women were randomised to receive either intravenous ferrous sucrose ( 200mg/24hours for two consecutive days ) or intravenous placebo , in addition to standard iron therapy .
METHODS	Clinical and laboratory data were obtained at 1 , 2 , and 6weeks .
METHODS	Haemoglobin and haematocrit at 1 , 2 , and 6weeks .
METHODS	Other haematological and clinical parameters , psychological status , and adverse side effects were also evaluated .
RESULTS	Haemoglobin and haematocrit values were comparable in women receiving intravenous iron or placebo in addition to oral iron therapy at any of the time points .
RESULTS	At 6weeks , haemoglobin level ( meanSD ) was 12.21.0 versus 12.20.9 g/dl , with a mean difference of -0.03 ( 95 % CI -0.6 to 0.6 ) , in the placebo and in the intravenous iron groups , respectively .
RESULTS	No differences were found between clinical symptoms of anaemia , psychological status , and adverse side effects between groups .
CONCLUSIONS	Intravenous iron added to oral iron therapy did not show significant benefits over placebo , neither in haemoglobin rise nor in symptoms or adverse side effects .

###24845165
OBJECTIVE	Evidence suggests a positive association between administration of psychoactive drugs and rates of cigarette smoking .
OBJECTIVE	Prevalence of smoking among opioid-dependent individuals , for example , is four times greater than the general population .
OBJECTIVE	We recently completed a randomized double-blind trial evaluating outpatient buprenorphine taper for prescription opioid ( PO ) abusers , which provided a unique opportunity to examine naturalistic changes in smoking among participants who detoxified without resumption of illicit opioid use .
METHODS	Participants received no smoking-cessation services and were not encouraged to alter their smoking in any way .
METHODS	A subset of 10 opioid-dependent smokers , who were randomized to receive the same 4-week buprenorphine taper and successfully completed detoxification , were included in the present study .
METHODS	They provided staff-observed urine specimens thrice-weekly throughout the 12-week trial .
METHODS	Specimens were analyzed on-site via enzyme-multiplied immunoassay for urinary cotinine , a metabolite of nicotine that provides a sensitive biochemical measure of smoking status .
RESULTS	Mean cotinine levels were significantly different across study phases , with significantly lower cotinine levels during taper ( 1317.5 ng/ml ) and post-taper ( 1015.8 ng/ml ) vs. intake ( 1648.5 ng/ml ) phases ( p '' s < .05 ) .
RESULTS	Overall , mean cotinine levels decreased by 38 % between intake and end-of-study , reflecting a reduction of approximately eight cigarettes per day .
CONCLUSIONS	These data provide additional evidence that opioids influence smoking and extend prior findings to include primary PO abusers , rigorous double-blind opioid dosing conditions and urinary cotinine .
CONCLUSIONS	These results also suggest that , while likely insufficient for complete cessation , patients who successfully taper from opioids may also experience concurrent reductions in smoking and thus may be ideal candidates for smoking cessation services .

###24581929
OBJECTIVE	We evaluated whether presenting prescription drug efficacy information in direct-to-consumer ( DTC ) advertising helps individuals accurately report a drug 's benefits and , if so , which numerical format is most helpful .
METHODS	We conducted a randomized , controlled study of individuals diagnosed with high cholesterol ( n = 2807 ) who viewed fictitious prescription drug print or television ads containing either no drug efficacy information or efficacy information in one of five numerical formats .
METHODS	We measured drug efficacy recall , drug perceptions and attitudes , behavioral intentions , and drug risk recall .
RESULTS	Individuals who viewed absolute frequency and/or percentage information more accurately reported drug efficacy than participants who viewed no efficacy information .
RESULTS	Participants who viewed relative frequency information generally reported drug efficacy less accurately than participants who viewed other numerical formats .
CONCLUSIONS	Adding efficacy information to DTC ads-both in print and on television-may potentially increase an individual 's knowledge of a drug 's efficacy , which may improve patient-provider communication and promote more informed decisions .
CONCLUSIONS	Providing quantitative efficacy information in a combination of formats ( e.g. , absolute frequency and percent ) may help patients remember information and make decisions about prescription drugs .

###25129247
OBJECTIVE	The aim of the present study was to investigate the analgesic and anti-inflammatory effects of dexketoprofen trometamol ( DT ) and paracetamol on deep acute somatic pain and inflammation in patients undergoing impacted third molar surgery .
OBJECTIVE	This study was planned to present benefits that we could obtain with low burden of drug .
METHODS	Effects of drugs , which were administered preemptively before the procedure , on pain , mouth-opening limitation , and swelling were assessed by visual analogue scale ( VAS ) , magnetic resonance imaging ( MRI ) , and mouth-opening measurement .
METHODS	Following surgery , time intervals when the patients first need to receive the drug were measured .
RESULTS	The VAS scores of the patients were lower in the side treated with DT than that in the paracetamol treated side .
RESULTS	There was no significant difference between the groups in terms of mouth-opening limitation .
RESULTS	MRI recordings revealed that swelling was lower in the side treated with paracetamol than DT treated side .
CONCLUSIONS	Administration of the drugs before surgery contributed to the postoperative patient comfort .
CONCLUSIONS	The analgesic activity of 12.5 mg dose of DT was similar to , even better than , the analgesic activity of 500 mg dose of paracetamol ; however , DT had insufficient anti-inflammatory efficacy .

###24378762
OBJECTIVE	This study aims to compare the effects of a lifestyle intervention using a behavioral therapy ( BT ) approach with the effects of a cardioprotective structured hypocaloric diet on metabolic syndrome in Mexican postmenopausal women .
METHODS	This study is a randomized clinical trial ( 2006-2009 ) of Mexican postmenopausal women with metabolic syndrome ( Adult Treatment Panel III criteria ) who were recruited from the Postmenopause Clinic of the National Institute of Perinatology in Mexico City .
METHODS	Women were assigned to one of two groups -- group 1 ( structured hypocaloric diet ; n = 63 ) : energy restriction ( -300 to -500 kcal/d ) emphasizing cardioprotective dietary changes ; and group 2 ( BT ; n = 55 ) : goal setting , problem-solving , and stimulus control to achieve cardioprotective dietary and lifestyle recommendations .
METHODS	Metabolic syndrome prevalence , as well as weight , waist circumference , fat mass , and fasting biochemical markers ( glucose and lipid profile ) , were measured at baseline and at 2 , 4 , and 6 months after the intervention .
METHODS	Metabolic syndrome risk ( relative risk and absolute risk reduction ) , mean differences between groups , and logistic regression were evaluated using Statistical Package for the Social Sciences software , version 17.0 .
RESULTS	A total of 118 women were studied ( mean [ SD ] age , 53.81 [ 6.43 ] y ) .
RESULTS	No baseline differences were observed between groups .
RESULTS	At the end of the study , a higher reduction in metabolic syndrome prevalence was observed in group 1 ( -38.1 % ) compared with group 2 ( -12.7 % ; relative risk , 0.237 ; 95 % CI , 0.092-0 .608 ; P = 0.003 ) .
RESULTS	The effect was maintained even when adjusted by age , hormone therapy and antihypertensive drug use .
CONCLUSIONS	A cardioprotective structured hypocaloric diet is more effective than the BT approach in reducing metabolic syndrome after 6 months of intervention .
CONCLUSIONS	Both strategies have positive effects on different individual cardiovascular risk factors .

###24686105
BACKGROUND	Randomized controlled trials ( RCTs ) are widely accepted as being the most efficient way of investigating the efficacy of psychological therapies .
BACKGROUND	However , researchers conducting RCTs commonly report difficulties in recruiting an adequate sample within planned timescales .
BACKGROUND	In an effort to overcome recruitment difficulties , researchers often are forced to expand their recruitment criteria or extend the recruitment phase , thus increasing costs and delaying publication of results .
BACKGROUND	Research investigating the effectiveness of recruitment strategies is limited , and trials often fail to report sufficient details about the recruitment sources and resources utilized .
OBJECTIVE	We examined the efficacy of strategies implemented during the Staying Well after Depression RCT in Oxford to recruit participants with a history of recurrent depression .
METHODS	We describe eight recruitment methods utilized and two further sources not initiated by the research team and examine their efficacy in terms of ( 1 ) the return , including the number of potential participants who contacted the trial and the number who were randomized into the trial ; ( 2 ) cost-effectiveness , comprising direct financial cost and manpower for initial contacts and randomized participants ; and ( 3 ) comparison of sociodemographic characteristics of individuals recruited from different sources .
RESULTS	Poster advertising , web-based advertising , and mental health worker referrals were the cheapest methods per randomized participant ; however , the ratio of randomized participants to initial contacts differed markedly per source .
RESULTS	Advertising online , via posters , and on a local radio station were the most cost-effective recruitment methods for soliciting participants who subsequently were randomized into the trial .
RESULTS	Advertising across many sources ( saturation ) was found to be important .
CONCLUSIONS	It may not be feasible to employ all the recruitment methods used in this trial to obtain participation from other populations , such as those currently unwell , or in other geographical locations .
CONCLUSIONS	Recruitment source was unavailable for participants who could not be reached after the initial contact .
CONCLUSIONS	Thus , it is possible that the efficiency of certain methods of recruitment was poorer than estimated .
CONCLUSIONS	Efficacy and costs of other recruitment initiatives , such as providing travel expenses to the in-person eligibility assessment and making follow-up telephone calls to candidates who contacted the recruitment team but could not be screened promptly , were not analysed .
CONCLUSIONS	Website advertising resulted in the highest number of randomized participants and was the second cheapest method of recruiting .
CONCLUSIONS	Future research should evaluate the effectiveness of recruitment strategies for other samples to contribute to a comprehensive base of knowledge for future RCTs .

###24746263
BACKGROUND	Interventions promoting physical activity by General Practitioners ( GPs ) lack a strong evidence base .
BACKGROUND	Recruiting participants to trials in primary care is challenging .
BACKGROUND	We investigated the feasibility of ( i ) delivering three interventions to promote physical activity in inactive participants and ( ii ) different methods of participant recruitment and randomised allocation .
METHODS	We recruited general practices from Devon , Bristol and Coventry .
METHODS	We used a 2-by-2 factorial design for participant recruitment and randomisation .
METHODS	Recruitment strategies were either opportunistic ( approaching patients attending their GP surgery ) or systematic ( selecting patients from practice lists and approaching them by letter ) .
METHODS	Randomisation strategies were either individual or by practice cluster .
METHODS	Feasibility outcomes included time taken to recruit the target number of participants within each practice .
METHODS	Participants were randomly allocated to one of three interventions : ( i ) written advice ( control ) ; ( ii ) brief GP advice ( written advice plus GP advice on physical activity ) , and ( iii ) brief GP advice plus a pedometer to self-monitor physical activity during the trial .
METHODS	Participants allocated to written advice or brief advice each received a sealed pedometer to record their physical activity , and were instructed not to unseal the pedometer before the scheduled day of data collection .
METHODS	Participant level outcomes were reported descriptively and included the mean number of pedometer steps over a 7-day period , and European Quality of Life ( EuroQoL ) -5 dimensions ( EQ-5D ) scores , recorded at 12weeks ' follow-up .
RESULTS	We recruited 24 practices ( 12 using each recruitment method ; 18 randomising by cluster , 6 randomising by individual participant ) , encompassing 131 participants .
RESULTS	Opportunistic recruitment was associated with less time to target recruitment compared with systematic ( mean difference ( days ) -54.9 , 95 % confidence interval ( CI ) -103.6 ; -6.2 ) but with greater loss to follow up ( 28.8 % versus .
RESULTS	6.9 % ; mean difference 21.9 % ( 95 % CI 9.6 % ; 34.1 % ) ) .
RESULTS	There were differences in the socio-demographic characteristics of participants according to recruitment method .
RESULTS	There was no clear pattern of change in participant level outcomes from baseline to 12weeks across the three arms .
CONCLUSIONS	Delivering and trialling GP-led interventions to promote physical activity is feasible , but trial design influences time to participant recruitment , participant withdrawal , and possibly , the socio-demographic characteristics of participants .
BACKGROUND	ISRCTN73725618 .

###24634285
BACKGROUND	In this study we tested the hypothesis that tirasemtiv , a selective fast skeletal muscle troponin activator that sensitizes the sarcomere to calcium , could amplify the response of muscle to neuromuscular input in humans .
METHODS	Healthy men received tirasemtiv and placebo in a randomized , double-blind , 4-period , crossover design .
METHODS	The deep fibular nerve was stimulated transcutaneously to activate the tibialis anterior muscle and produce dorsiflexion of the foot .
METHODS	The force-frequency relationship of tibialis anterior dorsiflexion was assessed after dosing .
RESULTS	Tirasemtiv increased force produced by the tibialis anterior in a dose - , concentration - , and frequency-dependent manner with the largest increases [ up to 24.5 % ( SE 3.1 ) , P < 0.0001 ] produced at subtetanic nerve stimulation frequencies ( 10 Hz ) .
CONCLUSIONS	The data confirm that tirasemtiv amplifies the response of skeletal muscle to nerve input in humans .
CONCLUSIONS	This outcome provides support for further studies of tirasemtiv as a potential therapy in conditions marked by diminished neuromuscular input .

###24308770
BACKGROUND	The present study addressed the ecological validity of the individual-focused experimental paradigm in sex research .
OBJECTIVE	The aim of this study was to investigate the effect of partner presence vs. absence in the laboratory testing situation , and of manipulation of attentional focus , on genital and subjective sexual arousal of healthy women and men .
METHODS	Sexually functional heterosexual men ( n = 12 ) and women ( n = 12 ) and their partners participated in this study .
METHODS	During partner presence , the partner sat opposite to the participant ; self-focused attention was experimentally manipulated by introducing , respectively , a semi-reflecting glass pane , and a wall-mounted camera .
METHODS	Perceived state self-focused attention and genital and subjective sexual arousal during presentation of audiovisual erotic film stimuli were assessed .
RESULTS	Partner presence resulted in higher perceived self-focus ( ( p ) ( 2 ) = 0.22 ) and lower genital responses to erotic stimulation ( ( p ) ( 2 ) = 0.21 ) .
RESULTS	The interaction of partner presence and increased self-focused attention differentially affected genital arousal in female and male participants ( ( p ) ( 2 ) = 0.38 ) .
RESULTS	The mean genital response in men was lower during private self-focus than during non-self-focus with the partner present but was higher during private self-focus with the the partner absent ( ( p ) ( 2 ) = 0.23 ) .
RESULTS	The genital response in women to public self-focus was lower than to private self-focus and to non-self-focus with their partner present ( ( p ) ( 2 ) = 0.36 ) .
RESULTS	With the partner absent , the genital response in women to private self-focus was lower than to non-self-focus ( ( p ) ( 2 ) = 0.23 ) .
RESULTS	Retrospective subjective arousal of women was higher with partner present ( M = 3.2 ) than with partner absent ( M = 2.9 ) , whereas men reported higher retrospective subjective arousal with their partner absent ( M = 3.5 ) than present ( M = 3.1 ) .
CONCLUSIONS	These findings suggest that mere presence of the partner impacts the sexual response differentially in women and men .
CONCLUSIONS	Enhancing the ecological validity of the individual-based laboratory paradigm for sex research warrants closer examination in future research .

###25479285
BACKGROUND	About one third of patients prescribed blood pressure or lipid-lowering drugs for the prevention of coronary heart disease and stroke do not take their medication as prescribed .
BACKGROUND	We conducted a randomized trial to evaluate text messaging as a means of improving adherence to cardiovascular disease preventive treatment .
METHODS	303 patients taking blood pressure and/or lipid-lowering medications were randomly assigned to being sent text messages ( Text group , 151 ) or not being sent them ( No text group , 152 ) .
METHODS	Texts were sent daily for 2 weeks , alternate days for 2 weeks and weekly thereafter for 22 weeks ( 6 months overall ) , using an automated computer programme .
METHODS	Patients were asked to respond on whether they had taken their medication , whether the text reminded them to do so if they had forgotten , and if they had not taken their medication to determine if there was a reason for not doing so .
METHODS	At 6 months , use of medication was assessed .
RESULTS	Two patients were lost to follow-up , providing data on 301 for analysis .
RESULTS	In the No text group 38/151 ( 25 % ) took less than 80 % of the prescribed regimen ( ie .
RESULTS	stopped medication completely or took it on fewer than 22 of the last 28 days of follow-up ) compared to 14/150 patients ( 9 % ) in the Text group - an improvement in adherence affecting 16 per 100 patients ( 95 % CI 7 to 24 ) , p < 0.001 .
RESULTS	The texts reminded 98/151 patients ( 65 % ) to take medication on at least one occasion and lead to 20/151 ( 13 % ) who stopped taking medication because of concern over efficacy or side-effects , resuming treatment .
CONCLUSIONS	In patients taking blood pressure or lipid-lowering treatment for the prevention of cardiovascular disease , text messaging improved medication adherence compared with no text messaging .
BACKGROUND	Controlled-Trials .
BACKGROUND	com ISRCTN74757601 .

###25045806
METHODS	A novel , fully bacterially produced recombinant virus-like particle ( VLP ) based influenza vaccine ( gH1-Qbeta ) against A/California/07 / 2009 ( H1N1 ) was tested in a double-blind , randomized phase I clinical trial at two clinical sites in Singapore .
METHODS	The trial evaluated the immunogenicity and safety of gH1-Qbeta in the presence or absence of alhydrogel adjuvant .
METHODS	Healthy adult volunteers with no or low pre-existing immunity against A/California/07 / 2009 ( H1N1 ) were randomized to receive two intramuscular injections 21 days apart , with 100g vaccine , containing 42g hemagglutinin antigen .
METHODS	Antibody responses were measured before and 21 days after each immunization by hemagglutination inhibition ( HAI ) assays .
METHODS	The primary endpoint was seroconversion on Day 42 , defined as percentage of subjects which reach a HAI titer 40 or achieve an at least 4-fold rise in HAI titer ( with pre-existing immunity ) .
METHODS	The co-secondary endpoints were safety and seroconversion on Day 21 .
RESULTS	A total of 84 Asian volunteers were enrolled in this study and randomized to receive the adjuvanted ( n = 43 ) or the non-adjuvanted ( n = 41 ) vaccine .
RESULTS	Of those , 43 and 37 respectively ( 95 % ) completed the study .
RESULTS	There were no deaths or serious adverse events reported during this trial .
RESULTS	A total of 535 adverse events occurred during treatment with 49.5 % local solicited symptoms , of mostly ( 76.4 % ) mild severity .
RESULTS	The most common treatment-related systemic symptom was fatigue .
RESULTS	The non-adjuvanted vaccine met all primary and secondary endpoints and showed seroconversion in 62.2 % and 70.3 % of participants respectively on Day 21 and Day 42 .
RESULTS	While the adjuvanted vaccine showed an increased seroconversion from 25.5 % ( Day 21 ) to 51.2 % ( Day 42 ) , it did not meet the immunogenicity endpoint .
CONCLUSIONS	In summary , non-adjuvanted gH1-Qbeta showed similar antibody mediated immunogenicity and a comparable safety profile in healthy humans to commercially available vaccines .
CONCLUSIONS	These results warrant the consideration of this VLP vaccine platform for the vaccination against influenza infection ( HSA CTC1300092 ) .

###24850433
BACKGROUND	Two percent chlorhexidine gluconate ( CHG ) is used in preparing the skin of surgical patients .
BACKGROUND	In practice , it often is diluted with saline prior to use .
BACKGROUND	Whether this affects efficacy is unknown , as the manufacturer does not address dilution but does recommend scrubbing twice .
BACKGROUND	We attempted to determine whether diluting CHG affects its antiseptic potency and if one scrub is as effective as two .
METHODS	To test effects of CHG dilution , 60 healthy subjects were recruited and randomized into a dilution group ( 20 % , 40 % , 60 % , 80 % , or 100 % CHG ) or a control group ( saline ) .
METHODS	One area of one foot of each subject was prepared , and colony-forming units ( CFU ) were counted at baseline and at 10min after preparation .
METHODS	In a second study , 60 subjects were again recruited .
METHODS	Based on the previous study , a 50 % dilution was applied as the scrub .
METHODS	Colony-forming units were calculated at baseline and after each CHG application .
RESULTS	Baseline CFU did not differ among the dilution groups ( p = 0.49 ) .
RESULTS	Subjects in all dilution groups exhibited nearly a 100 % decrease in CFU , whereas the control group exhibited an 80 % decrease .
RESULTS	These results were statistically significant ( p < 0.01 ) .
RESULTS	In the second study , the CFU values after two scrubs ( mean 0.1 ; range 0-3 ) were significantly lower than after one scrub ( mean 3.6 , range 0-100 ) ( p = 0.02 ) .
CONCLUSIONS	Diluting CHG to a concentration as low as 0.4 % does not affect antiseptic efficacy .
CONCLUSIONS	The manufacturer-recommended two scrubs is superior to one scrub at reducing skin bacterial colony counts .

###25516016
BACKGROUND	Although uncomplicated cystitis is often self-limiting , most such patients will be prescribed antibiotic treatment .
BACKGROUND	We are investigating whether treatment of cystitis with an NSAID is as effective as an antibiotic in achieving symptomatic resolution .
METHODS	This is a randomized , controlled , double blind trial following the principles of Good Clinical Practice .
METHODS	Women between the ages of 18 to 60 presenting with symptoms of uncomplicated cystitis are screened for eligibility .
METHODS	500 women from four sites in Norway , Sweden and Denmark are allocated to treatment with 600 mg ibuprofen three times a day or 200 mg mecillinam three times a day for three days .
METHODS	Allocation is conducted using block randomization .
METHODS	The primary outcome is the number of patients who feel cured by day four as recorded in a diary .
METHODS	Adverse events will be handled and reported in accordance with Good Clinical Practice .
CONCLUSIONS	If treatment of uncomplicated cystitis with ibuprofen is as effective as mecillinam for symptom relief , we can potentially reduce the use of antibiotics on a global scale .
BACKGROUND	EudraCTnr : 2012-002776-14 .
BACKGROUND	ClinicalTrials.gov : NCT01849926 .

###24974232
BACKGROUND	Intravenous loop diuretics are a cornerstone of therapy in acutely decompensated heart failure ( ADHF ) .
BACKGROUND	We sought to determine if there are any differences in clinical outcomes between intravenous bolus and continuous infusion of loop diuretics .
METHODS	Subjects with ADHF within 12 hours of hospital admission were randomly assigned to continuous infusion or twice daily bolus therapy with furosemide .
METHODS	There were three co-primary endpoints assessed from admission to discharge : the mean paired changes in serum creatinine , estimated glomerular filtration rate ( eGFR ) , and reduction in B-type natriuretic peptide ( BNP ) .
METHODS	Secondary endpoints included the rate of acute kidney injury ( AKI ) , change in body weight and six months follow-up evaluation after discharge .
RESULTS	A total of 43 received a continuous infusion and 39 were assigned to bolus treatment .
RESULTS	At discharge , the mean change in serum creatinine was higher ( +0.8 0.4 versus -0.8 0.3 mg/dl P < 0.01 ) , and eGFR was lower ( -9 7 versus +5 6 ml/min/1 .73 m ( 2 ) P < 0.05 ) in the continuous arm .
RESULTS	There was no significant difference in the degree of weight loss ( -4.1 1.9 versus -3.5 2.4 kg P = 0.23 ) .
RESULTS	The continuous infusion arm had a greater reduction in BNP over the hospital course , ( -576 655 versus -181 527 pg/ml P = 0.02 ) .
RESULTS	The rates of AKI were comparable ( 22 % and 15 % P = 0.3 ) between the two groups .
RESULTS	There was more frequent use of hypertonic saline solutions for hyponatremia ( 33 % versus 18 % P < 0.01 ) , intravenous dopamine infusions ( 35 % versus 23 % P = 0.02 ) , and the hospital length of stay was longer in the continuous infusion group ( 14.3 5 versus 11.5 4 days , P < 0.03 ) .
RESULTS	At 6 months there were higher rates of re-admission or death in the continuous infusion group , 58 % versus 23 % , ( P = 0.001 ) and this mode of treatment independently associated with this outcome after adjusting for baseline and intermediate variables ( adjusted hazard ratio = 2.57 , 95 % confidence interval , 1.01 to 6.58 P = 0.04 ) .
CONCLUSIONS	In the setting of ADHF , continuous infusion of loop diuretics resulted in greater reductions in BNP from admission to discharge .
CONCLUSIONS	However , this appeared to occur at the consequence of worsened renal filtration function , use of additional treatment , and higher rates of rehospitalization or death at six months .
BACKGROUND	ClinicalTrials.gov NCT01441245 .
BACKGROUND	Registered 23 September 2011 .

###25212409
BACKGROUND	Prolonged exposure ( PE ) therapy for post-traumatic stress disorder ( PTSD ) in military veterans has established efficacy , but is ineffective for a substantial number of patients .
BACKGROUND	PE is also associated with high dropout rates .
BACKGROUND	We hypothesized that hydrocortisone augmentation would enhance symptom improvement and reduce drop-out rates by diminishing the distressing effects of traumatic memories retrieved during imaginal exposure .
BACKGROUND	We also hypothesized that in responders , hydrocortisone augmentation would be more effective in reversing glucocorticoid indices associated with PTSD than placebo augmentation .
METHODS	Twenty-four veterans were randomized to receive either 30 mg oral hydrocortisone or placebo prior to PE sessions 3-10 in a double-blind protocol .
METHODS	Glucocorticoid receptor sensitivity was assessed in cultured peripheral blood mononuclear cells ( PBMC ) using the in vitro lysozyme inhibition test and was determined before and after treatment .
METHODS	Intent-to-treat analysis was performed using latent growth curve modeling of treatment effects on change in PTSD severity over time .
METHODS	Veterans who no longer met diagnostic criteria for PTSD at post-treatment were designated as responders .
RESULTS	Veterans randomized to hydrocortisone or placebo augmentation did not differ significantly in clinical severity or glucocorticoid sensitivity at pre-treatment .
RESULTS	Hydrocortisone augmentation was associated with greater reduction in total PTSD symptoms compared to placebo , a finding that was explained by significantly greater patient retention in the hydrocortisone augmentation condition .
RESULTS	A significant treatment condition by responder status interaction for glucocorticoid sensitivity indicated that responders to hydrocortisone augmentation had the highest pre-treatment glucocorticoid sensitivity ( lowest lysozyme IC50-DEX ) that diminished over the course of treatment .
RESULTS	There was a significant association between decline in glucocorticoid responsiveness and improvement in PTSD symptoms among hydrocortisone recipients .
CONCLUSIONS	The results of this pilot study suggest that hydrocortisone augmentation of PE may result in greater retention in treatment and thereby promote PTSD symptom improvement .
CONCLUSIONS	Further , the results suggest that particularly elevated glucocorticoid responsiveness at pre-treatment may identify veterans likely to respond to PE combined with an intervention that targets glucocorticoid sensitivity .
CONCLUSIONS	Confirmation of these findings will suggest that pharmacologic interventions that target PTSD-associated glucocorticoid dysregulation may be particularly helpful in promoting a positive clinical response to PTSD psychotherapy .

###25399731
BACKGROUND	Hypertension develops early in patients with autosomal dominant polycystic kidney disease ( ADPKD ) and is associated with disease progression .
BACKGROUND	The renin-angiotensin-aldosterone system ( RAAS ) is implicated in the pathogenesis of hypertension in patients with ADPKD .
BACKGROUND	Dual blockade of the RAAS may circumvent compensatory mechanisms that limit the efficacy of monotherapy with an angiotensin-converting-enzyme ( ACE ) inhibitor or angiotensin II-receptor blocker ( ARB ) .
METHODS	In this double-blind , placebo-controlled trial , we randomly assigned 486 patients , 18 to 64 years of age , with ADPKD ( estimated glomerular filtration rate [ GFR ] , 25 to 60 ml per minute per 1.73 m ( 2 ) of body-surface area ) to receive an ACE inhibitor ( lisinopril ) and placebo or lisinopril and an ARB ( telmisartan ) , with the doses adjusted to achieve a blood pressure of 110/70 to 130/80 mm Hg .
METHODS	The composite primary outcome was the time to death , end-stage renal disease , or a 50 % reduction from the baseline estimated GFR .
METHODS	Secondary outcomes included the rates of change in urinary aldosterone and albumin excretion , frequency of hospitalizations for any cause and for cardiovascular causes , incidence of pain , frequency of ADPKD-related symptoms , quality of life , and adverse study-medication effects .
METHODS	Patients were followed for 5 to 8 years .
RESULTS	There was no significant difference between the study groups in the incidence of the composite primary outcome ( hazard ratio with lisinopril-telmisartan , 1.08 ; 95 % confidence interval , 0.82 to 1.42 ) .
RESULTS	The two treatments controlled blood pressure and lowered urinary aldosterone excretion similarly .
RESULTS	The rates of decline in the estimated GFR , urinary albumin excretion , and other secondary outcomes and adverse events , including hyperkalemia and acute kidney injury , were also similar in the two groups .
CONCLUSIONS	Monotherapy with an ACE inhibitor was associated with blood-pressure control in most patients with ADPKD and stage 3 chronic kidney disease .
CONCLUSIONS	The addition of an ARB did not alter the decline in the estimated GFR .
CONCLUSIONS	( Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others ; HALT-PKD [ Study B ] ClinicalTrials.gov number , NCT01885559 . )

###26043591
OBJECTIVE	Surgical extraction of lower third molars is followed by mild or severe postoperative pain which peaks at maximal intensity in the first 12 hours and has a significant impact on a patient 's postoperative quality of life .
OBJECTIVE	The use of long-acting local anaesthetics is a promising strategy to improve postoperative analgesia .
OBJECTIVE	The aim of the present study was to investigate analgesic parameters and patient satisfaction after using 0.5 % levobupivacaine ( Lbup ) , 0.5 % bupivacaine ( Bup ) and 2 % lidocaine with epinephrine 1:80,000 ( Lid + Epi ) for an inferior alveolar nerve block following lower third molar surgery .
METHODS	A total of 102 patients ( ASA I ) were divided into three groups , each of which received either 3 mL of Lbup , Bup or Lid + Epi .
METHODS	The intensity of postoperative analgesia was measured using a verbal rating scale ( VRS ) .
METHODS	The total amounts of rescue analgesics were recorded on the first and during seven postoperative days .
METHODS	Patients satisfaction was noted using a modified verbal scales .
RESULTS	A significantly higher level of postoperative pain was recorded in Lid + Epi group compared to Bup and Lbup groups .
RESULTS	No significant differences were seen between Bup and Lbup , but a significant reduction in the need for rescue analgesics was seen postoperatively in both Lbup and Bup ( 50 % ) in comparison with Lid + Epi ( 80 % ) in the first 24 hours .
RESULTS	The same significant trend in rescue analgesic consumption was recorded for seven postoperative days .
RESULTS	Patients ' overall satisfaction was significantly lower for Lid + Epi ( 10 % ) than for Lbup ( 56 % ) and Bup ( 52 % ) .
CONCLUSIONS	The use of a new and long-acting local anaesthetic 0.5 % levobupivacaine is clinically relevant and effective for an inferior alveolar nerve block and postoperative pain control after third molar surgery .
CONCLUSIONS	In our study Lbup and Bup controled postoperative pain more efficiently after lower third molar surgery compared to Lid + Epi .

###25007692
BACKGROUND	Awake fiberoptic intubation is the gold standard for management of predicted difficult intubation .
BACKGROUND	The purpose of this study was to test whether Glide Scope video laryngoscopy ( GVL ) will provide significant advantages over fiberoptic bronchoscopy ( FOB ) for awake intubation in morbidly obese patients with predicted difficult intubation .
BACKGROUND	We therefore tested the hypothesis that intubation using GVL is faster than intubation with FOB .
METHODS	64 morbidly obese patients with predicted difficult intubation undergoing laparoscopic bariatric surgery were enrolled in this study .
METHODS	Patients were randomly assigned to receive awake oral intubation by either GVL or FOB .
METHODS	After airway topical anesthesia and sedation using target controlled remifentanil infusion to a Ramsay sedation scale of 3 , wee compared the two devices for time to intubate , successful intubation on first attempt , glottic view using Cormack and Lehane score system , response of the patient to scope , patients satisfaction and incidence of postoperative sore throat and hoarseness .
RESULTS	Intubation time was 84 + / - 37.9 seconds and 73.6 + / - 31.1 seconds for FOB and GVL respectively .
RESULTS	75 % of patients were successfully intubated on the first attempt with FOB compared to 80.6 % with GVL .
RESULTS	Grade I/II glottic view was reported with GVL in 96.7 % of patients compared to 100 % with FOB .
RESULTS	The highest target concentration of remifentanil to maintain patients sedated during intubation was 2.4 + / - 0.6 ng/ml and 2.2 + / - 0.8 ng/ml in FOB and GVL respectively .
RESULTS	No significant differences regarding maximum patient response to intubation , adverse effects or patient satisfaction were recorded between groups .
CONCLUSIONS	GVL can be used as a useful alternative to FOB in morbidly obese patients with predicted difficult intubation .

###25122429
BACKGROUND	Bevacizumab , a recombinant humanized monoclonal antibody against vascular endothelial growth factor , was approved by the US Food and Drug Administration for the treatment of advanced non-small-cell lung cancer ( NSCLC ) in combination with carboplatin and paclitaxel .
BACKGROUND	ARIES ( Avastin Regimens : Investigation of Effectiveness and Safety ) , a prospective observational cohort study , evaluated outcomes in a large , community-based population of patients with first-line NSCLC .
METHODS	From 2006 to 2009 , ARIES enrolled patients with locally advanced or metastatic NSCLC who were eligible for bevacizumab , excluding those with predominantly squamous histology .
METHODS	Patients were required to provide informed consent and to have initiated bevacizumab with chemotherapy within 4 months before enrollment .
METHODS	There were no protocol-defined treatments or assessments .
METHODS	The dosing of bevacizumab and chemotherapy , and the choice of chemotherapy regimen , was at the discretion of the treating physician .
RESULTS	ARIES enrolled 1967 patients with first-line NSCLC .
RESULTS	At study closure , median follow-up was 12.5 months ( range , 0.2-65 .5 ) .
RESULTS	Median age was 65 years ( range , 31-93 ) , and 252 patients ( 12.8 % ) identified as never smokers .
RESULTS	Median progression-free survival was 6.6 months ( 95 % confidence interval , 6.3-6 .9 ) , and median overall survival was 13.0 months ( 95 % confidence interval , 12.2-13 .8 ) with first-line bevacizumab plus chemotherapy .
RESULTS	Incidences of bevacizumab-associated adverse events ( 19.7 % overall ) were consistent with those in randomized controlled trials of bevacizumab in NSCLC .
CONCLUSIONS	Results from ARIES demonstrate similar outcomes to randomized controlled trials of bevacizumab when added to standard chemotherapy in a real-world patient population with advanced NSCLC .

###24649993
OBJECTIVE	To evaluate effects of maropitant , acepromazine , and electroacupuncture on morphine-related signs of nausea and vomiting in dogs and assess sedative effects of the treatments .
METHODS	Randomized controlled clinical trial .
METHODS	222 dogs .
METHODS	Dogs received 1 of 6 treatments : injection of saline ( 0.9 % NaCl ) solution , maropitant citrate , or acepromazine maleate or electroacupuncture treatment at 1 acupoint , 5 acupoints , or a sham acupoint .
METHODS	Morphine was administered after 20 minutes of electroacupuncture treatment or 20 minutes after injectable treatment .
METHODS	Vomiting and retching events and signs of nausea and sedation were recorded .
RESULTS	Incidence of vomiting and retching was significantly lower in the maropitant ( 14/37 [ 37.8 % ] ) group than in the saline solution ( 28/37 [ 75.7 % ] ) and sham-acupoint electroacupuncture ( 32/37 [ 86.5 % ] ) groups .
RESULTS	The number of vomiting and retching events in the maropitant ( 21 ) , acepromazine ( 38 ) , 1-acupoint ( 35 ) , and 5-acupoint ( 34 ) groups was significantly lower than in the saline solution ( 88 ) and sham-acupoint electroacupuncture ( 109 ) groups .
RESULTS	Incidence of signs of nausea was significantly lower in the acepromazine group ( 3/37 [ 8.1 % ] ) than in the sham-acupoint group ( 15/37 [ 40.5 % ] ) .
RESULTS	Mean nausea scores for the saline solution , maropitant , and sham-acupoint electroacupuncture groups increased significantly after morphine administration , whereas those for the acepromazine , 1-acupoint electroacupuncture , and 5-acupoint electroacupuncture groups did not .
RESULTS	Mean sedation scores after morphine administration were significantly higher in dogs that received acepromazine than in dogs that received saline solution , maropitant , and sham-acupoint electroacupuncture treatment .
CONCLUSIONS	Maropitant treatment was associated with a lower incidence of vomiting and retching , compared with control treatments , and acepromazine and electroacupuncture appeared to prevent an increase in severity of nausea following morphine administration in dogs .

###25428264
BACKGROUND	Over-diagnosis of malaria among African children results in mismanagement of non-malaria infections .
BACKGROUND	Limited laboratory capacity makes it difficult to implement policies that recommend pre-treatment confirmation of infections so a new approach with a package for on-the-spot management of fevers was evaluated .
METHODS	Febrile children presenting to outpatient clinic were randomized to receive either a ` test-treat ' package ( history with clinical examination ; point-of-care tests ; choice of artesunate-amodiaquine , co-amoxiclav and/or paracetamol ) or routine outpatient care in a secondary health care facility in Kumasi , Ghana .
METHODS	A diagnosis of malaria , bacterial , viral or mixed malarial and bacterial infections was made using pre-defined criteria .
METHODS	Outcome was resolution of all symptoms including fever on day 7 .
RESULTS	The median age of the patients was 37.5 months ( IQR : 19 to 66 months ) , with 56.7 % being males .
RESULTS	Compared to routine care the test-treat package resulted in less diagnoses of malaria , ( 37.2 % vs 46.2 % , p = 0.190 ) and mixed malaria and bacterial infections ( 14.0 % vs 53.8 % , p < 0.001 ) but more diagnoses of viral ( 33.1 % vs 0.0 % , p < 0.001 ) and bacterial infections only ( 15.7 % vs 0.0 % , p < 0.001 ) .
RESULTS	Less anti-malarials ( 51.2 % vs 100.0 % , p < 0.001 ) and antibiotics ( 29.7 % vs 48.7 % , p < 0.001 ) , were prescribed in the test-treat group on completion of study , more test-treat package patients were clinically well ( 99.2 % vs 80.7 % , p < 0.001 ) and febrile ( 0.8 % vs 10.1 % , p = 0.001 ) and less were admitted for inpatient care ( 0.0 % vs 8.4 % p = 0.001 ) compared to the routine care group .
CONCLUSIONS	Test-treat package improves the effectiveness of outpatient diagnosis and treatment of children with fever and reduces inappropriate prescribing of anti-malarials and antibiotics .
CONCLUSIONS	The package provides clinicians with the option for immediate diagnosis and treatment of non-malaria fevers .
CONCLUSIONS	The test-treat package now needs to be evaluated in other settings including primary health care facilities .

###24705442
BACKGROUND	The 2007 American College of Cardiologists/American Heart Association Guidelines on Perioperative Cardiac Evaluation and Care for Noncardiac Surgery is the standard for perioperative cardiac evaluation .
BACKGROUND	Recent work has shown that residents and anesthesiologists do not apply these guidelines when tested .
BACKGROUND	This research hypothesized that a decision support tool would improve adherence to this consensus guideline .
METHODS	Anesthesiology residents at four training programs participated in an unblinded , prospective , randomized , cross-over trial in which they completed two tests covering clinical scenarios .
METHODS	One quiz was completed from memory and one with the aid of an electronic decision support tool .
METHODS	Performance was evaluated by overall score ( % correct ) , number of incorrect answers with possibly increased cost or risk of care , and the amount of time required to complete the quizzes both with and without the cognitive aid .
METHODS	The primary outcome was the proportion of correct responses attributable to the use of the decision support tool .
RESULTS	All anesthesiology residents at four institutions were recruited and 111 residents participated .
RESULTS	Use of the decision support tool resulted in a 25 % improvement in adherence to guidelines compared with memory alone ( P < 0.0001 ) , and participants made 77 % fewer incorrect responses that would have resulted in increased costs .
RESULTS	Use of the tool was associated with a 3.4-min increase in time to complete the test ( P < 0.001 ) .
CONCLUSIONS	Use of an electronic decision support tool significantly improved adherence to the guidelines as compared with memory alone .
CONCLUSIONS	The decision support tool also prevented inappropriate management steps possibly associated with increased healthcare costs .

###24948348
OBJECTIVE	To examine the relationships between stressful life events and physiological measures , adherence to prescribed oral medication regimens , depressive symptoms , and impaired quality of life ( QoL ) in adolescents with recent-onset type 2 diabetes ( T2D ) .
METHODS	Data were collected from 497 ethnically diverse participants ( 66 % female ) in the final year of the Treatment Options for Type 2 Diabetes in Adolescents and Youth multicenter clinical trial .
METHODS	Exposure to 32 possible events over the previous year and rating of subsequent distress were collected by self-report and summarized as a major stressors score .
METHODS	This score was analyzed for relationship to glycemic control ( hemoglobin A1c and treatment failure ) , body mass index , diagnosis of hypertension or triglyceride dyslipidemia , adherence to a prescribed oral medication regimen , presence of depressive symptoms , and impaired QoL .
RESULTS	The total number of major stressful life events in the adolescents with T2D was calculated , with 33 % reporting none , 67 % reporting 1 , 47 % reporting 2 , 33 % reporting 3 , and 20 % reporting 4 .
RESULTS	There were no associations between the major stressors score and physiological measures or diagnosis of comorbidities .
RESULTS	The odds of medication nonadherence increased significantly from those reporting 1 major stressor ( OR , 1.58 ; P = .0265 ) to those reporting 4 major stressors ( OR , 2.70 ; P = .0009 ) .
RESULTS	Significant odds of elevated depressive symptoms and impaired QoL were also found with increased reporting of major stressors .
CONCLUSIONS	Exposure to major stressful life events is associated with lower adherence to prescribed oral medication regimens and impaired psychosocial functioning in adolescents with T2D .

###26501533
OBJECTIVE	Low back pain ( LBP ) is responsible for more than 2.5 million visits to US emergency departments ( EDs ) annually .
OBJECTIVE	These patients are usually treated with nonsteroidal anti-inflammatory drugs , acetaminophen , opioids , or skeletal muscle relaxants , often in combination .
OBJECTIVE	To compare functional outcomes and pain at 1 week and 3 months after an ED visit for acute LBP among patients randomized to a 10-day course of ( 1 ) naproxen + placebo ; ( 2 ) naproxen + cyclobenzaprine ; or ( 3 ) naproxen + oxycodone/acetaminophen .
METHODS	This randomized , double-blind , 3-group study was conducted at one urban ED in the Bronx , New York City .
METHODS	Patients who presented with nontraumatic , nonradicular LBP of 2 weeks ' duration or less were eligible for enrollment upon ED discharge if they had a score greater than 5 on the Roland-Morris Disability Questionnaire ( RMDQ ) .
METHODS	The RMDQ is a 24-item questionnaire commonly used to measure LBP and related functional impairment on which 0 indicates no functional impairment and 24 indicates maximum impairment .
METHODS	Beginning in April 2012 , a total of 2588 patients were approached for enrollment .
METHODS	Of the 323 deemed eligible for participation , 107 were randomized to receive placebo and 108 each to cyclobenzaprine and to oxycodone/acetaminophen .
METHODS	Follow-up was completed in December 2014 .
METHODS	All participants were given 20 tablets of naproxen , 500 mg , to be taken twice a day .
METHODS	They were randomized to receive either 60 tablets of placebo ; cyclobenzaprine , 5 mg ; or oxycodone , 5 mg/acetaminophen , 325 mg .
METHODS	Participants were instructed to take 1 or 2 of these tablets every 8 hours , as needed for LBP .
METHODS	They also received a standardized 10-minute LBP educational session prior to discharge .
METHODS	The primary outcome was improvement in RMDQ between ED discharge and 1 week later .
RESULTS	Demographic characteristics were comparable among the 3 groups .
RESULTS	At baseline , median RMDQ score in the placebo group was 20 ( interquartile range [ IQR ] ,17 -21 ) , in the cyclobenzaprine group 19 ( IQR,17-21 ) , and in the oxycodone/acetaminophen group 20 ( IQR,17-22 ) .
RESULTS	At 1-week follow-up , the mean RMDQ improvement was 9.8 in the placebo group , 10.1 in the cyclobenzaprine group , and 11.1 in the oxycodone/acetaminophen group .
RESULTS	Between-group difference in mean RMDQ improvement for cyclobenzaprine vs placebo was 0.3 ( 98.3 % CI , -2.6 to 3.2 ; P = .77 ) , for oxycodone/acetaminophen vs placebo , 1.3 ( 98.3 % CI , -1.5 to 4.1 ; P = .28 ) , and for oxycodone/acetaminophen vs cyclobenzaprine , 0.9 ( 98.3 % CI , -2.1 to 3.9 ; P = .45 ) .
CONCLUSIONS	Among patients with acute , nontraumatic , nonradicular LBP presenting to the ED , adding cyclobenzaprine or oxycodone/acetaminophen to naproxen alone did not improve functional outcomes or pain at 1-week follow-up .
CONCLUSIONS	These findings do not support use of these additional medications in this setting .
BACKGROUND	clinicaltrials.gov Identifier : NCT01587274 .

###25092781
OBJECTIVE	To improve survival rates in children with acute myeloid leukemia ( AML ) , we evaluated gemtuzumab-ozogamicin ( GO ) , a humanized immunoconjugate targeted against CD33 , as an alternative to further chemotherapy dose escalation .
OBJECTIVE	Our primary objective was to determine whether adding GO to standard chemotherapy improved event-free survival ( EFS ) and overall survival ( OS ) in children with newly diagnosed AML .
OBJECTIVE	Our secondary objectives examined outcomes by risk group and method of intensification .
METHODS	Children , adolescents , and young adults ages 0 to 29 years with newly diagnosed AML were enrolled onto Childrens Oncology Group trial AAML0531 and then were randomly assigned to either standard five-course chemotherapy alone or to the same chemotherapy with two doses of GO ( 3 mg/m2/dose ) administered once in induction course 1 and once in intensification course 2 ( two of three ) .
RESULTS	There were 1,022 evaluable patients enrolled .
RESULTS	GO significantly improved EFS ( 3 years : 53.1 % v. 46.9 % ; hazard ratio [ HzR ] , 0.83 ; 95 % CI , 0.70 to 0.99 ; P. 04 ) but not OS ( 3 years : 69.4 % v. 65.4 % ; HzR , 0.91 ; 95 % CI , 0.74 to 1.13 ; P = .39 ) .
RESULTS	Although remission was not improved ( 88 % v. 85 % ; P = .15 ) , posthoc analyses found relapse risk ( RR ) was significantly reduced among GO recipients overall ( 3 years : 32.8 % v. 41.3 % ; HzR , 0.73 ; 95 % CI , 0.58 to 0.91 ; P = .006 ) .
RESULTS	Despite an increased postremission toxic mortality ( 3 years : 6.6 % v. 4.1 % ; HzR , 1.69 ; 95 % CI , 0.93 to 3.08 ; P = .09 ) , disease-free survival was better among GO recipients ( 3 years : 60.6 % v. 54.7 % ; HzR , 0.82 ; 95 % CI , 0.67 to 1.02 ; P = .07 ) .
CONCLUSIONS	GO added to chemotherapy improved EFS through a reduction in RR for children and adolescents with AML .

###25268730
BACKGROUND	Fatigue is one of many unintended consequences of shift work in the nursing profession .
BACKGROUND	Natural health products ( NHPs ) for fatigue are becoming an increasingly popular topic of clinical study ; one such NHP is Rhodiola rosea .
BACKGROUND	A well-designed , rigorously conducted randomized controlled trial is required before therapeutic claims for this product can be made .
OBJECTIVE	To compare the efficacy of R. rosea with placebo for reducing fatigue in nursing students on shift work .
METHODS	A parallel-group randomized , double-blinded , placebo-controlled trial of 18-55 year old students from the Faculty of Nursing from the University of Alberta , participating in clinical rotations between January 2011 and September 2011 .
METHODS	Participants were randomized to take 364 mg of either R. rosea or identical placebo at the start of their wakeful period and up to one additional capsule within the following four hours on a daily basis over a 42-day period .
RESULTS	The primary outcome was reduction in fatigue over the 42-day trial period measured using the Vitality-subscale of the RAND-36 , cross-validated by the visual analogue scale for fatigue ( VAS-F ) .
RESULTS	Secondary outcomes included health-related quality of life , individualized outcomes assessment , and adverse events .
RESULTS	A total of 48 participants were randomized to R. rosea ( n = 24 ) or placebo ( n = 24 ) .
RESULTS	The mean change in scores on the Vitality-subscale was significantly different between the study groups at day 42 in favor of placebo ( -17.3 ( 95 % CI -30.6 , -3.9 ) , p = 0.011 ) , The mean change in scores on the VAS-F was also significantly difference between study groups at day 42 in favour of placebo ( 1.9 ( 95 % CI 0.4 , 3.5 ) , p = 0.015 ) .
RESULTS	Total number of adverse events did not differ between R. rosea and placebo groups .
CONCLUSIONS	This study indicates that among nursing students on shift work , a 42-day course of R. Rosea compared with placebo worsened fatigue ; however , the results should be interpreted with caution .
BACKGROUND	Clinicaltrials.gov NCT01278992 .

###25099775
BACKGROUND	Stroke is one of the most common causes of cognitive impairment .
BACKGROUND	Up to 75 % of stroke survivors may be considered to have cognitive impairment , which severely limit individual autonomy for successful reintegration into family , work and social life .
BACKGROUND	The clinical efficacy of acupuncture with Baihui ( DU20 ) and Shenting ( DU24 ) in stroke and post-stroke cognitive impairment has been previously demonstrated .
BACKGROUND	Computer-assisted cognitive training is part of conventional cognitive rehabilitation and has also shown to be effective in improvement of cognitive function of affected patients .
BACKGROUND	However , the cognitive impairment after stroke is so complexity that one single treatment can not resolve effectively .
BACKGROUND	Besides , the effects of acupuncture and RehaCom cognitive training have not been systematically compared , nor has the possibility of a synergistic effect of combination of the two therapeutic modalities been evaluated .
BACKGROUND	Our primary aim of this trial is to evaluate the synergistic effect of acupuncture and RehaCom cognitive training on cognitive dysfunction after stroke .
METHODS	A randomized controlled trial of 2 2 factorial design will be conducted in the Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine .
METHODS	A total of 240 patients with cognitive dysfunction after stroke who meet the eligibility criteria will be recruited and randomized into RehaCom training group , acupuncture group , a combination of both or control group in a 1:1:1:1 ratio .
METHODS	All patients will receive conventional treatment .
METHODS	The interventions will last for 12 weeks ( 30 min per day , Monday to Friday every week ) .
METHODS	Evaluations will be conducted by blinded assessors at baseline and again at 4 , 8 and 12 weeks .
METHODS	Outcome measurements include mini-mental state examination ( MMSE ) , Montreal cognitive assessments ( MoCA ) , functional independence measure scale ( FIM ) and adverse events .
CONCLUSIONS	The results of this trial are expected to clarify the synergistic effect of acupuncture and RehaCom cognitive training on cognitive dysfunction after stroke .
CONCLUSIONS	Furthermore , to confirm whether combined or alone of acupuncture and RehaCom cognitive training , is more effective than conventional treatment in the management of post-stroke cognitive dysfunction .
BACKGROUND	Chinese Clinical Trial Registry : ChiCTR-TRC-13003704 .

###24264781
BACKGROUND	Anastomotic leakage of pancreaticojejunostomy ( PJ ) remains the single most important source of morbidity after pancreaticoduodenectomy ( PD ) .
BACKGROUND	The primary aim of this randomized clinical trial comparing PG with PJ after PD was to test the hypothesis that invaginated PG would result in a lower rate and severity of pancreatic fistula .
METHODS	Patients undergoing PD were randomized to receive either a duct-to-duct PJ or a double-layer invaginated PG .
METHODS	The primary endpoint was the rate of pancreatic fistula , using the definition of the International Study Group on Pancreatic Fistula .
METHODS	Secondary endpoints were the evaluation of severe abdominal complications ( Clavien-Dindo grade IIIa or above ) , endocrine and exocrine function .
RESULTS	Of 123 patients randomized , 58 underwent PJ and 65 had PG .
RESULTS	The incidence of pancreatic fistula was significantly higher following PJ than for PG ( 20 of 58 versus 10 of 65 respectively ; P = 0.014 ) , as was the severity of pancreatic fistula ( grade A : 2 versus 5 per cent ; grade B-C : 33 versus 11 per cent ; P = 0.006 ) .
RESULTS	The hospital readmission rate for complications was significantly lower after PG ( 6 versus 24 per cent ; P = 0.005 ) , weight loss was lower ( P = 0.025 ) and exocrine function better ( P = 0.022 ) .
CONCLUSIONS	The rate and severity of pancreatic fistula was significantly lower with this PG technique compared with that following PJ .
BACKGROUND	ISRCTN58328599 ( http://www.controlled-trials.com ) .

###24425125
OBJECTIVE	Predictors of outcome after aneurysmal subarachnoid hemorrhage have been determined previously through hypothesis-driven methods that often exclude putative covariates and require a priori knowledge of potential confounders .
OBJECTIVE	Here , we apply a data-driven approach , principal component analysis , to identify baseline patient phenotypes that may predict neurological outcomes .
METHODS	Principal component analysis was performed on 120 subjects enrolled in a prospective randomized trial of clazosentan for the prevention of angiographic vasospasm .
METHODS	Correlation matrices were created using a combination of Pearson , polyserial , and polychoric regressions among 46 variables .
METHODS	Scores of significant components ( with eigenvalues > 1 ) were included in multivariate logistic regression models with incidence of severe angiographic vasospasm , delayed ischemic neurological deficit , and long-term outcome as outcomes of interest .
RESULTS	Sixteen significant principal components accounting for 74.6 % of the variance were identified .
RESULTS	A single component dominated by the patients ' initial hemodynamic status , World Federation of Neurosurgical Societies score , neurological injury , and initial neutrophil/leukocyte counts was significantly associated with poor outcome .
RESULTS	Two additional components were associated with angiographic vasospasm , of which one was also associated with delayed ischemic neurological deficit .
RESULTS	The first was dominated by the aneurysm-securing procedure , subarachnoid clot clearance , and intracerebral hemorrhage , whereas the second had high contributions from markers of anemia and albumin levels .
CONCLUSIONS	Principal component analysis , a data-driven approach , identified patient phenotypes that are associated with worse neurological outcomes .
CONCLUSIONS	Such data reduction methods may provide a better approximation of unique patient phenotypes and may inform clinical care as well as patient recruitment into clinical trials .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00111085 .

###25327812
OBJECTIVE	To evaluate the effects of an Al ( 3 + ) - and Mg ( 2 + ) - containing antacid , ferrous sulfate , and calcium carbonate on the absorption of nemonoxacin in healthy humans .
METHODS	Two single-dose , open-label , randomized , crossover studies were conducted in 24 healthy male Chinese volunteers ( 12 per study ) .
METHODS	In Study 1 , the subjects orally received nemonoxacin ( 500 mg ) alone , or an antacid ( containing 318 mg of Al ( 3 + ) and 496 mg of Mg ( 2 + ) ) plus nemonoxacin administered 2 h before , concomitantly or 4 h after the antacid .
METHODS	In Study 2 , the subjects orally received nemonoxacin ( 500 mg ) alone , or nemonoxacin concomitantly with ferrous sulfate ( containing 60 mg of Fe ( 2 + ) ) or calcium carbonate ( containing 600 mg of Ca ( 2 + ) ) .
RESULTS	Concomitant administration of nemonoxacin with the antacid significantly decreased the area under the concentration-time curve from time 0 to infinity ( AUC0 - ) for nemonoxacin by 80.5 % , the maximum concentration ( Cmax ) by 77.8 % , and urine recovery ( Ae ) by 76.3 % .
RESULTS	Administration of nemonoxacin 4 h after the antacid decreased the AUC0 - for nemonoxacin by 58.0 % , Cmax by 52.7 % , and Ae by 57.7 % .
RESULTS	Administration of nemonoxacin 2 h before the antacid did not affect the absorption of nemonoxacin .
RESULTS	Administration of nemonoxacin concomitantly with ferrous sulfate markedly decreased AUC0 - by 63.7 % , Cmax by 57.0 % , and Ae by 59.7 % , while concomitant administration of nemonoxacin with calcium carbonate mildly decreased AUC0 - by 17.8 % , Cmax by 14.3 % , and Ae by 18.4 % .
CONCLUSIONS	Metal ions , Al ( 3 + ) , Mg ( 2 + ) , and Fe ( 2 + ) markedly decreased the absorption of nemonoxacin in healthy Chinese males , whereas Ca ( 2 + ) had much weaker effects .
CONCLUSIONS	To avoid the effects of Al ( 3 + ) and Mg ( 2 + ) - containing drugs , nemonoxacin should be administered 2 h before them .

###25642682
OBJECTIVE	This study was conducted to compare the effectiveness of PETTLEP-based imagery , and traditional imagery interventions , on performance of passing skill in volleyball .
METHODS	36 beginners male volleyball players ( Mage = 13.5 years , SD = 0.55 years ) with 5-6 months practice experience were randomly assigned to one of three groups : physical practice + PETTLEP imagery ( PP+PI ) ( N. = 15 ) , physical practice + traditional imagery ( N. = 15 ) , and physical practice only ( PP ; N. = 15 ) .
METHODS	Subjects in the PP+PI group applied the seven components of PETTLEP imagery training ; whereas subjects in the PP+TI engaged in a relaxation session before imagery and used response laden motor imagery scripts .
METHODS	The two groups completed 15 minutes of imagery training followed immediately by 13 minutes of `` passing '' practice three times per week .
METHODS	The PP group completed only 13 minutes of `` passing '' practice three times per week .
METHODS	Each group performed its respective tasks for 7 weeks .
METHODS	A pre-test took place during the first practice session in which `` passing '' was assessed .
METHODS	After the 7-week practice program , a post-test took place followed by a retention test , one `` no-practice '' week later .
RESULTS	All groups improved significantly ( P < 0.05 ) from pre - to post-test and retention test .
RESULTS	However , as hypothesised the PP+PI group improved more ( P < 0.05 ) than the PP+TI and PP groups .
CONCLUSIONS	The findings , therefore , support the effectiveness of PETTLEP imagery in enhancing performance of passing skill in volleyball when combined with physical practice .

###25663125
OBJECTIVE	This multicenter , randomized , open-labeled , clinical trial evaluated the efficacy and safety of cisplatin/5-fluorouracil ( 5-FU ) hepatic arterial infusion chemotherapy ( CF-HAIC ) versus adriamycin adding to CF-HAIC ( ACF-HAIC ) in advanced HCC patients .
METHODS	Fifty-six patients with advanced HCC were randomized to two treatment groups : ( 1 ) CF-HAIC group [ n = 29 , 5-FU , 500 mg/m ( 2 ) on days 1-3 , and cisplatin , 60 mg/m ( 2 ) on day 2 ] and ( 2 ) ACF-HAIC group [ n = 27 , adriamycin , 50 mg/m ( 2 ) on day 1 , 5-FU , 500 mg/m ( 2 ) on days 1-3 , and cisplatin , 60 mg/m ( 2 ) on day 2 ] every 4 weeks via an implantable port system .
METHODS	Primary efficacy endpoint was overall survival ( OS ) .
METHODS	Treatment response and time to progression were secondary endpoints .
RESULTS	Treatment response rates did not differ significantly between the two treatment groups .
RESULTS	Time to progression ( 5.4 vs. 5.8 months , P = 0.863 ) and OS ( 11.1 vs. 8.8 months , P = 0.448 ) were not significantly different .
RESULTS	When the factors affecting patient OS were analyzed , disease control rate [ P < 0.001 , HR 6.437 ( 95 % CI 2.580-16 .064 ) ] was independently associated with OS .
RESULTS	Age ( 60 years ) and serum AFP level ( 200 ng/dL ) also were significant factors for OS [ P = 0.007 , HR 4.945 ( 95 % CI 1.543-15 .850 ) , P = 0.048 , HR 2.677 ( 95 % CI 1.010-7 .095 ) , respectively ] .
RESULTS	Grade 4 treatment-related toxicity and mortality was not observed in both groups .
CONCLUSIONS	Although both HAIC regimens are safe and effective in patients with advanced HCC , HAIC adding adriamycin did not show delayed tumor progression and survival benefit compared to CF-HAIC in advanced HCC .

###24673044
OBJECTIVE	To assess the effectiveness and safety on post-stroke dysphagia in chronic stage treated with magnetic-ball sticking therapy at the auricular points .
METHODS	Ninety cases of post-apoplexy dysphagia in chronic stage were randomized into an auricular points group and an acupuncture group .
METHODS	In the auricular points group , the magnetic-ball sticking therapy was applied to subcortex ( pizhixia , AT4 ) , brainstem ( naogan , AT ( 3,4 i ) ) , mouth ( kou , CO1 ) , cheek ( mianjia , LO ( 5,6 i ) ) , tongue ( she , LO2 ) and throat ( yanhou , TG3 ) on one ear each time , and were changed on the other ear once every 3 days .
METHODS	In the acupucnture group , acupuncture was applied to Feng-chi ( GB 20 ) , Yifeng ( TE 17 ) , Shanglianquan ( Extra ) , Jinjin ( EX-HN 12 ) , Yuye ( EX-HN 13 ) , Shuigou ( GV 26 ) and Tongli ( TH 5 ) , etc. .
METHODS	The needles were retained for 30 min in each treatment .
METHODS	The treatment was gi-yen once a day in the two groups and the treatment of 6 days made one session .
METHODS	There was 1 day at an interval among the sessions .
METHODS	Totally , 3 sessions of treatment were required .
METHODS	The video fluoroscopic swallowing study ( VFSS ) was performed for 4 kinds of food with different properties and shapes in each patient .
METHODS	The main indices were Rosenbek penetration-aspiration score , oral-retaining score and throat-retaining score .
METHODS	The efficacy , and the incidences of aspiration pneumonia and malnutrition were compared between the two groups .
METHODS	The nutrition indices were compared before and after treatment between the two groups , such as the skinfold thickness of triceps brachii muscle , serum albumin and peralbumin .
RESULTS	In 21 days of treatment , in the auricular points group , the 1 mL liquid loversol Rosenbek penetration-aspiration score ( 1.51 + / - 0.69 ) , oral-retaining score ( 1.17 + / - 0.38 ) and throat-retaining score ( 1.30 + / - 0.66 ) were all lower than those ( 2.51 + / - 0.67 , 1.63 + / - 0.72 , 1.67 + / - 0.7 ) in the acupuncture group separately .
RESULTS	The 10 mL liquid loversol Rosenbek penetration-aspiration score ( 2.27 + / - 0.65 ) , oral-retaining score ( 1.60 + / - 0.50 ) and throat-retaining score ( 1.49 + / - 0.51 ) were all lower than those ( 4.19 + / - 0.73 , 2.30 + / - 0.51 , 2.41 + / - 0.50 ) in the acupuncture group separately .
RESULTS	The 10 mL paste loversol Rosenbek penetration-aspiration score ( 1.68 + / - 0.81 ) , oral-retaining score ( 1.11 + / - 0.31 ) and throat-retaining score ( 1.10 + / - 0.31 ) were all lower than those ( 3.91 + / - 0.68 , 1.63 + / - 0.76 , 1.60 + / - 0.76 ) in the acupuncture group separately .
RESULTS	The 1/4 cake-form loversol Rosenbek penetration-aspiration score ( 2.60 + / - 0.65 ) , oral-retaining score ( 1.40 + / - 0.50 ) and throat-retaining score ( 1.74 + / - 0.49 ) were all lower than those ( 4.14 + / - 1.10 , 2.40 + / - 0.73 , 2.30 + / - 0.83 ) in the acupuncture group separately .
RESULTS	The incidence of aspiration pneumonia was 14.9 % ( 7/47 ) in the auricular points group , which was lower than 55.0 % ( 22/40 ) in the acupuncture group ( P < 0.01 ) .
RESULTS	The incidence of malnutrition was 8.5 % ( 4/47 ) in the auricular points group , which was lower than 50.0 % ( 20/40 ) in the acupuncture group ( P < 0.01 ) .
RESULTS	In 21 days of treatment , the results of the skinfold thickness of triceps brachii muscle and serum albumin in the auricular points group were better than those in the acupuncture group ( both P < 0.05 ) .
CONCLUSIONS	The magnetic-ball sticking therapy at auricular points achieves the definite efficacy on post-stoke dysphagia in chronic stage and decreases the incidences of aspiration pneumonia and malnutrition .
CONCLUSIONS	The efficacy of this therapy is better than acupuncture .

###25595237
OBJECTIVE	Several characteristics of bone-targeted agents are considered when making treatment decisions .
OBJECTIVE	This study evaluated physicians ' therapy preferences for preventing skeletal-related events ( SREs ) in patients with bone metastases secondary to solid tumors .
METHODS	A Web-enabled , discrete-choice experiment online survey was conducted among physicians who treated patients with bone metastases and solid tumors in the United States .
METHODS	Respondents chose between pairs of hypothetical medications defined by combinations of six attributes at varying levels for two hypothetical patients .
METHODS	Preference weights for attribute levels were estimated using a random-parameters logit model .
RESULTS	In total , 200 physicians completed the survey .
RESULTS	Their mean age was 52 years , 57 % were in practice for more than 15 years , 37 % were oncologists , and 65 % treated 10 or fewer patients with bone metastases weekly .
RESULTS	Out-of-pocket cost to patients was the most important attribute overall .
RESULTS	Among clinical outcomes , time to first SRE and risk of renal impairment were the most important attributes .
RESULTS	Statistically significant preferences were observed for all attribute levels for time to first SRE , risk of renal impairment , and mode of administration .
RESULTS	Predicted choice probability analysis showed that physicians preferred a hypothetical medication with attributes similar to those of denosumab over one with attributes similar to those of zoledronic acid .
CONCLUSIONS	Physicians indicated that clinical attributes are important when considering bone-targeting therapy for bone metastases , but consistent with the current health care landscape , patient out-of-pocket cost was the most important .
CONCLUSIONS	With health care costs being increasingly shifted to patients , physicians require accurate information about co-pays and assistance programs to avoid patients receiving less costly , yet potentially inferior , treatment .

###24837754
BACKGROUND	Despite their positive motivation to quit , many smokers do not attempt to quit or relapse soon after their quit attempt .
BACKGROUND	This study investigated the predictors of successful and unsuccessful quit attempts among smokers motivated to quit smoking .
METHODS	We conducted secondary data analysis among respondents motivated to quit within 6 months , randomized to the control group ( N = 570 ) of a Web-based smoking cessation intervention study .
METHODS	Using chi-square tests and ANOVA with Tukey post hoc comparisons , we investigated baseline differences by smoking status ( successful quitter/relapse/persistent smoker ) assessed after 6 weeks ( N = 214 ) .
METHODS	To identify independent predictors of smoking status , multivariate multinomial logistic regression analyses were conducted .
RESULTS	Successful quitters at 6-week follow-up ( 26 % ) had reported significantly higher baseline levels of self-efficacy than relapsers ( 45 % ) and persistent smokers ( 29 % ) .
RESULTS	Furthermore , both successful quitters and relapsers had reported a significantly higher baseline intention to quit than persistent smokers and successful quitters had reported significantly more preparatory planning at baseline than persistent smokers .
RESULTS	Results from regression analyses showed that smokers ' baseline intention to quit positively predicted quit attempts reported after 6 weeks , while self-efficacy positively predicted quit attempt success .
CONCLUSIONS	Different factors appear to play a role in predicting quit attempts and their success .
CONCLUSIONS	Whereas intention to quit only appeared to play a role in predicting quit attempts , self-efficacy was the main factor predicting quit attempt success .
CONCLUSIONS	More research is needed to determine the role of preparatory planning and plan enactment and to investigate whether these findings can be replicated on the long term .

###24950720
BACKGROUND	AirSeal is a novel class of valve-free insufflation system that enables a stable pneumoperitoneum with continuous smoke evacuation and carbon dioxide ( CO ) recirculation during laparoscopic surgery .
BACKGROUND	Comparison data to standard CO pressure pneumoperitoneum insufflators is scarce .
BACKGROUND	The aim of this study is to evaluate the potential advantages of AirSeal compared to a standard CO insufflator .
METHODS	This is a single center randomized controlled trial comparing elective laparoscopic cholecystectomy , colorectal surgery and hernia repair with AirSeal ( group A ) versus a standard CO pressure insufflator ( group S ) .
METHODS	Patients are randomized using a web-based central randomization and registration system .
METHODS	Primary outcome measures will be operative time and level of postoperative shoulder pain by using the visual analog score ( VAS ) .
METHODS	Secondary outcomes include the evaluation of immunological values through blood tests , anesthesiological parameters , surgical side effects and length of hospital stay .
METHODS	Taking into account an expected dropout rate of 5 % , the total number of patients is 182 ( n = 91 per group ) .
METHODS	All tests will be two-sided with a confidence level of 95 % ( P < 0.05 ) .
CONCLUSIONS	The duration of an operation is an important factor in reducing the patient 's exposure to CO pneumoperitoneum and its adverse consequences .
CONCLUSIONS	This trial will help to evaluate if the announced advantages of AirSeal , such as clear sight of the operative site and an exceptionally stable working environment , will facilitate the course of selected procedures and influence operation time and patients clinical outcome .
BACKGROUND	ClinicalTrials.gov NCT01740011 , registered 23 November 2012 .

###25675568
OBJECTIVE	To compare the difference in the clinical efficacy on perennial allergic rhinitis between three nasal points acupuncture therapy and the oral administration of loratadine so as to provide the better acupuncture program in clinical treatment .
METHODS	Sixty cases were randomized into an acupuncture group ( 30 cases ) and a medication group ( 30 cases ) .
METHODS	In the acupuncture group , acupuncture was applied to three nasal points [ Yingxiang ( LI 20 ) , Yintang ( EX-HN 3 ) , Bitong ( Extra ) ] and acupoints selected by syndrome differentiation .
METHODS	Acupuncture was given once every two days , three times a week , for 4 weeks totally .
METHODS	In the medication group , loratadine was prescribed for oral administration , 10 mg every day , for 4 weeks .
METHODS	The symptom and physical sign scores before and after treatment , as well the short-term and long-term efficacy were compared between the two groups .
RESULTS	The total effective rate was 96.7 % ( 29/30 ) in the acupuncture group and was 93.3 % ( 28/30 ) in the medication group after treatment .
RESULTS	The efficacy was similar between the two groups ( P > 0.05 ) .
RESULTS	In follow-up , the total effective rate was 86.7 % ( 26/30 ) in the acupuncture group , which was better than 56.7 % ( 17/30 , P < 0.05 ) in the medication group .
RESULTS	The scores of symptoms and physical signs after treatment and in follow-up were all reduced apparently as compared with those before treatment in the patients of the two groups ( all P < 0.05 ) .
RESULTS	The scores of symptoms and physical signs were reduced more apparently in the acupuncture group as compared with those in the medication group in follow-up ( all P < 0.05 ) .
CONCLUSIONS	The acupuncture at three nasal points and the acupoints selected by syndrome differentiation achieves the similar short-term efficacy on perennial allergic rhinitis as compared with the oral administration of loratadine .
CONCLUSIONS	The acupuncture therapy presents the obvious advantages on long-term efficacy .

###24577880
OBJECTIVE	Comparing the overall and differential effects of psychodynamic psychotherapy ( PDT ) versus cognitive behavior therapy ( CBT ) for social anxiety disorder ( SAD ) .
METHODS	Patients with a primary SAD ( N = 47 ) were randomly assigned to PDT ( N = 22 ) or CBT ( N = 27 ) .
METHODS	Both PDT and CBT consisted of up to 36 sessions ( average PDT 31.4 and CBT 19.8 sessions ) .
METHODS	Assessments took place at waitlist : pretest , after 12 and 24 weeks for those who received longer treatment : posttest , 3-month and 1-year follow-up .
METHODS	Changes in the main outcome measure self-reported social anxiety composite , as well as in other psychopathology , social skills , negative social beliefs , public self-consciousness , defense mechanisms , personal goals , independent rater 's judgments of SAD and general improvement , and approach behavior during an objective test , were analyzed using multilevel analysis .
RESULTS	No improvement occurred during waitlist .
RESULTS	Treatments were highly efficacious , with large within-subject effect sizes for social anxiety , but no differences between PDT and CBT on general and treatment-specific measures occurred .
RESULTS	Remission rates were over 50 % and similar for PDT and CBT .
RESULTS	Personality disorders did not influence the effects of PDT or CBT .
CONCLUSIONS	PDT and CBT are both effective approaches for SAD .
CONCLUSIONS	Further research is needed on the cost-effectiveness of PDT versus CBT , on different lengths PDT , and on patient preferences and their relationship to outcome of PDT versus CBT .

###24768161
OBJECTIVE	To examine how prenatal drug exposure ( PDE ) to heroin/cocaine and behavioral problems relate to adolescent drug experimentation .
METHODS	The sample included African-American adolescents ( mean age = 14.2 years , SD = 1.2 ) with PDE ( n = 73 ) and a nonexposed community comparison ( n = 61 ) .
METHODS	PDE status was determined at delivery through toxicology analysis and maternal report .
METHODS	Internalizing/externalizing problems were assessed during adolescence with the Behavior Assessment System for Children , Second Edition .
METHODS	Drug experimentation was assessed by adolescent report and urine analysis .
METHODS	Logistic regression evaluated the likelihood of drug experimentation related to PDE and behavioral problems , adjusting for age , gender , PDE , perceived peer drug use , and caregiver drug use .
METHODS	Interaction terms examined gender modification .
RESULTS	Sixty-seven subjects ( 50 % ) used drugs : 25 ( 19 % ) used tobacco/alcohol only and 42 ( 31 % ) used marijuana/illegal drugs .
RESULTS	Ninety-four subjects ( 70 % ) perceived peer drug use .
RESULTS	PDE significantly increased the risk of tobacco/alcohol experimentation ( odds ratio = 3.07 , 95 % confidence interval [ CI ] 1.09-8 .66 , p = .034 ) but not after covariate adjustment ( adjusted odds ratio [ aOR ] = 1.16 , 95 % CI .31 -4.33 , p > .05 ) .
RESULTS	PDE was not related to the overall or marijuana/illegal drug experimentation .
RESULTS	The likelihood of overall drug experimentation was doubled per SD increase in externalizing problems ( aOR = 2.28 , 95 % CI 1.33-3 .91 , p = .003 ) and , among girls , 2.82 times greater ( aOR = 2.82 , 95 % CI 1.34-5 .94 , p = .006 ) per SD increase in internalizing problems .
RESULTS	Age and perceived peer drug use were significant covariates .
CONCLUSIONS	Drug experimentation was relatively common ( 50 % ) , especially in the context of externalizing problems , internalizing problems ( girls only ) , older age , and perceived peer drug use .
CONCLUSIONS	Findings support the Problem Behavior Theory and suggest that adolescent drug prevention addresses behavioral problems and promotes prosocial peer groups .

###25856933
BACKGROUND	Intra-articular triamcinolone in combination with DMARDs may be able to achieve faster and tighter control of disease activity in early rheumatoid arthritis that may be the key to preventing or minimizing later deformities .
OBJECTIVE	To compare the efficacy of a combination of Disease Modifying Anti-Rheumatoid Drugs ( DMARDs ) with Intra-articular Glucocorticoids versus only DMARDs in a group of patients with early Rheumatoid Arthritis ( RA ) .
METHODS	Fifty patients diagnosed as Rheumatoid Arthritis ( RA ) by American Rheumatology Association ( ARA ) criteria ( 1987 ) with disease duration less than two years were randomized into two groups .
METHODS	The Control group received a combination of Methotrexate 15 mg daily with Sulfasalazine 2 gm daily for 3 months and the Study group received the above combination along with Intra-articular injections of Triamcinolone acetate ( 40 mg per ml ) in each of the swollen joints at the start of the study .
METHODS	Outcome was assessed in terms of Disease Activity Score ( DAS-28 ) , American College of Rheumatology ( ACR ) 20/50/70 criteria and number of rescue medications used at the end of 3 months .
RESULTS	The study group had significant reductions in DAS 28 scores ( 3.39 versus 4.99 in control group ) and significantly more subjects achieved the ACR 20/50/70 criteria at the end of 3 months ( 100/60/36 % versus 84/20/0 % ) Secondary end-points like tender and swollen joint count , ESR , early morning stiffness , health assessment questionnaire ( HAQ ) scores and general health status were significantly reduced in the study group .
RESULTS	Also , significantly lesser rescue medications were needed in the study group .
CONCLUSIONS	Combination of DMARDs with Intra-articular corticosteroids is significantly better than DMARDs alone in early RA .

###24673517
OBJECTIVE	The Ipswich Touch Test is a novel method to detect subjects with diabetes with loss of foot sensation and is simple , safe , quick , and easy to perform and teach .
OBJECTIVE	This study determines whether it can be used by relatives and/or carers to detect reduced foot sensation in the setting of the patient 's home .
METHODS	The test involves lightly and briefly ( 1-2 s ) touching the tips of the first , third and fifth toes of both feet with the index finger .
METHODS	Reduced foot sensation was defined as 2 insensate areas .
METHODS	Patients due to attend clinic over a 4-week period were invited by post .
METHODS	The invitation contained detailed instructions and a sheet for recording the results .
METHODS	The findings were compared with those obtained in clinic using the 10-g monofilament at the same six sites .
RESULTS	Of 331 patients ( 174 males ) , 25.1 % ( n = 83 ) had 2 insensate areas to 10-g monofilament testing .
RESULTS	Compared with this , the Ipswich Touch Test at home had a sensitivity of 78.3 % and a specificity of 93.9 % .
RESULTS	The predictive values of detecting ` at-risk ' feet were positive at 81.2 % and negative at 92.8 % .
RESULTS	The likelihood ratios were positive at 12.9 and negative at 0.23 .
CONCLUSIONS	With clearly written instructions , this simple test can be used by non-professionals to accurately assess for loss of protective sensation .
CONCLUSIONS	We believe that the Ipswich Touch Test may also be a useful educational adjunct to improve awareness of diabetes foot disease in patients and relatives alike and empower them to seek appropriate care if sensation was found to be abnormal .

###24709775
OBJECTIVE	The cellular immunity has a profound impact on the status of hepatitis C virus ( HCV ) infection .
OBJECTIVE	However , the response of cellular immunity on the virological response in patients with antiviral treatment remains largely unclear .
OBJECTIVE	We aimed to clarify the response of peripheral T cells and monocytes in chronic hepatitis C patients with antiviral treatment .
METHODS	Patients with chronic hepatitis C were treated either with interferon alpha-2b plus ribavirin ( n = 37 ) or with pegylated interferon alpha-2a plus ribavirin ( n = 33 ) for up to 24 weeks .
METHODS	Frequencies of peripheral regulatory T-cells ( Tregs ) , programmed death-1 ( PD-1 ) expressing CD4 + T-cells or CD8 + T-cells and toll-like receptor ( TLR ) 3 expressing CD14 + monocytes were evaluated by flow cytometry in patients at baseline , 12 and 24 weeks following treatment and in 20 healthy controls .
RESULTS	Frequencies of Tregs , PD-1 and TLR3 expressing cells were higher in patients than those in control subjects ( P < 0.05 ) .
RESULTS	Patients with complete early virological response ( cEVR ) showed lower Tregs , PD-1 expressing CD4 + or CD8 + T-cells than those without cEVR at 12 weeks ( P < 0.05 ) .
RESULTS	Patients with low TLR3 expressing CD14 + monocytes at baseline had a high rate of cEVR ( P < 0.05 ) .
CONCLUSIONS	Low peripheral TLR3 expressing CD14 + monocytes at baseline could serve as a predictor for cEVR of antiviral therapy in chronic HCV-infected patients .
CONCLUSIONS	The cEVR rates were significantly increased in the patients with reduced circulating Tregs , PD-1 expressing CD4 + or CD8 + T-cells .
BACKGROUND	Chinese Clinical Trial Registry ChiCTR10001090 .

###24509458
BACKGROUND	Few randomized trials have compared the results of Doppler-guided transanal hemorrhoid dearterialization with mucopexy and excisional open hemorrhoidectomy .
BACKGROUND	Few studies have reported long-term results .
OBJECTIVE	The aim of this study is to evaluate the results of Doppler-guided transanal hemorrhoid dearterialization with mucopexy compared with excisional open hemorrhoidectomy in patients with grade III hemorrhoids .
METHODS	This is a prospective randomized study registered at clinicaltrials.gov ( NCT01263431 ) .
METHODS	A power analysis assessed the study 's sample size .
METHODS	Patients were randomly assigned to undergo either hemorrhoidectomy or Doppler-guided hemorrhoid dearterialization plus mucopexy .
METHODS	The test , Mann-Whitney U test , Student t test , and a regression model were used , as appropriate .
METHODS	This study was conducted at the Department of Surgery , San Raffaele Scientific Institute , Milan , Italy .
METHODS	Fifty consecutive patients were treated for grade III hemorrhoids from July to November 2010 .
METHODS	The primary outcome was postoperative pain .
METHODS	The secondary outcomes included postoperative morbidity , the resumption of social and/or working activity , patient satisfaction , and the relapse of symptoms at 1 and 24 months .
RESULTS	No major complications occurred in either group .
RESULTS	The median visual analog scale scores for pain in the hemorrhoidectomy and Doppler-guided dearterialization plus mucopexy groups on days 1 , 7 , 14 , and 30 were 7 vs 5.5 , 3 vs 2.5 , 1 vs 0 , and 0 vs 0 ( p > 0.05 ) .
RESULTS	The median work resumption day was the 22nd in the hemorrhoidectomy group and the 10th in the Doppler-guided dearterialization plus mucopexy group ( p = 0.09 ) .
RESULTS	Patient satisfaction at 1 and 24 postoperative months , with the use of a 4-point scale , was 3 vs 4 and 4 vs 4 ( p > 0.05 ) .
RESULTS	During the follow-up , 2 patients in the dearterialization group required ambulatory treatment , and 1 patient in each group required further surgery for symptom relapse .
CONCLUSIONS	Nonvalidated questionnaires were used in the follow-up .
CONCLUSIONS	Cost analysis was not performed .
CONCLUSIONS	Compared with hemorrhoidectomy , dearterialization with mucopexy resulted in similar postoperative pain and morbidity , and a similar long-term cure rate .

###25213055
BACKGROUND	Management of antihistamine refractory chronic idiopathic urticaria ( CIU ) has poorly defined therapeutic options .
OBJECTIVE	To evaluate the efficacy of dapsone ( 4,4 ' - diaminodiphenylsulfone ) in antihistamine refractory CIU compared with placebo .
METHODS	Twenty-two patients with antihistamine refractory CIU were randomly assigned to 100 mg of dapsone daily or placebo for 6 weeks in a 14-week double-blind , placebo-controlled crossover trial .
METHODS	End points were measured from a daily diary that reflected the weekly hive score , the weekly itch score , and a visual analog scale ( VAS ) score .
METHODS	Secondary to a carryover effect , the first period results were analyzed as a parallel design that compared placebo with dapsone directly by using repeated-measures analysis .
RESULTS	After 6 weeks , the patients in the dapsone arm showed mean improvement over baseline in VAS ( 2.3 [ 95 % CI , 0.6-4 .1 ] , P = .01 ) , urticaria score ( -3.5 [ 95 % CI , -6.2 to -0.9 ] , P = .01 ) , and itch score ( -4.8 [ 95 % CI , -7.6 to -2.1 ] , P = .001 ) , whereas the placebo arm showed no improvement over baseline for VAS , urticaria , or itch scores .
RESULTS	Dapsone showed greater improvement compared with placebo for itch ( P = .047 ) and VAS ( P = .04 ) .
RESULTS	Of the 22 patients , 3 showed complete resolution of hives and itch with dapsone , whereas 31 % and 41 % had 50 % resolution of hives and itch , respectively .
RESULTS	No serious adverse effects were observed with dapsone .
CONCLUSIONS	To our knowledge , this is the first double-blind , placebo controlled study of dapsone in CIU and indicates that dapsone has efficacy in patients with antihistamine refractory CIU .

###25526597
OBJECTIVE	In alcohol-dependent patients , alcohol cues evoke increased activation in mesolimbic brain areas , such as the nucleus accumbens and the amygdala .
OBJECTIVE	Moreover , patients show an alcohol approach bias , a tendency to more quickly approach than avoid alcohol cues .
OBJECTIVE	Cognitive bias modification training , which aims to retrain approach biases , has been shown to reduce alcohol craving and relapse rates .
OBJECTIVE	The authors investigated effects of this training on cue reactivity in alcohol-dependent patients .
METHODS	In a double-blind randomized design , 32 abstinent alcohol-dependent patients received either bias modification training or sham training .
METHODS	Both trainings consisted of six sessions of the joystick approach-avoidance task ; the bias modification training entailed pushing away 90 % of alcohol cues and 10 % of soft drink cues , whereas this ratio was 50/50 in the sham training .
METHODS	Alcohol cue reactivity was measured with functional MRI before and after training .
RESULTS	Before training , alcohol cue-evoked activation was observed in the amygdala bilaterally , as well as in the right nucleus accumbens , although here it fell short of significance .
RESULTS	Activation in the amygdala correlated with craving and arousal ratings of alcohol stimuli ; correlations in the nucleus accumbens again fell short of significance .
RESULTS	After training , the bias modification group showed greater reductions in cue-evoked activation in the amygdala bilaterally and in behavioral arousal ratings of alcohol pictures , compared with the sham training group .
RESULTS	Decreases in right amygdala activity correlated with decreases in craving in the bias modification but not the sham training group .
CONCLUSIONS	These findings provide evidence that cognitive bias modification affects alcohol cue-induced mesolimbic brain activity .
CONCLUSIONS	Reductions in neural reactivity may be a key underlying mechanism of the therapeutic effectiveness of this training .

###25632615
OBJECTIVE	To compare the effectiveness of misoprostol sublingual and oral routes before manual vacuum aspiration ( MVA ) in first trimester termination of pregnancy .
METHODS	A double-blinded randomized controlled trial was conducted infirst trimester termination ofpregnancy cases .
METHODS	Eighty cases were recruited and divided into sublingual and oral groups .
METHODS	Both groups were randomized to receive 400 microg misoprostol two hours prior to MVA .
METHODS	Main outcomes were cervical dilatation , operative time , complications , side effects , pain scores , and patient satisfactions .
RESULTS	Sublingual group had significantly more cervical dilatation and shorter operative time than oral group ( 7.3 + / - 1.5 vs. 5.9 + / - 1.4 mm , p < 0.001 and 5.2 + / - 3.3 vs. 7.3 + / - 4.6 min , p = 0.02 , respectively ) .
RESULTS	However there were similar side effects , pain scores , and patient satisfactions in two groups .
RESULTS	The present study had no uterine perforation , cervical tear hemorrhage , or re-evacuation .
CONCLUSIONS	Sublingual misoprostol route was more effective for cervical priming prior to MVA in first trimester therapeutic abortion than oral route .

###24325697
OBJECTIVE	To compare the safety and efficacy of laser debulking ( LD ) and drug-eluting balloon ( DEB ) angioplasty to treatment with DEB angioplasty alone in patients affected by critical limb ischemia ( CLI ) and superficial femoral artery ( SFA ) chronic stent occlusion in a prospective , randomized study .
METHODS	Among 448 CLI patients treated from December 2009 to March 2011 , 48 patients ( 39 men ; mean age 72.77.8 years ) with chronic SFA in-stent occlusion were randomly assigned to treatment using LD+DEB ( n = 24 ) or DEB angioplasty alone ( n = 24 ) .
METHODS	Patency at 12 months was the primary outcome measure ; secondary outcomes were target lesion revascularization ( TLR ) and clinical success at 12 months .
RESULTS	In the LD+DEB group , the patency rates at 6 and 12 months ( 91.7 % and 66.7 % , respectively ) were significantly higher ( p = 0.01 ) than in the DEB only patients ( 58.3 % and 37.5 % , respectively ) .
RESULTS	TLR at 12 months was 16.7 % in the LD+DEB group and 50 % in the DEB only group ( p = 0.01 ) .
RESULTS	Two ( 8 % ) patients needed major amputations in the LD+DEB group vs. 11 ( 46 % ) in the DEB only group at 12 months ( p = 0.003 ) .
CONCLUSIONS	In this small initial experience , combined treatment with LD and DEB angioplasty is correlated with better outcomes in CLI patients with occluded SFA stents .

###24916058
OBJECTIVE	Hypertension is one of the most common co-existing conditions in patients with chronic pain , and the potential effects of an analgesic on heart rate and blood pressure are of particular concern for patients with hypertension .
OBJECTIVE	The purpose of this analysis was to evaluate changes in blood pressure and heart rate with tapentadol extended release ( ER ) treatment in patients with hypertension .
METHODS	We performed a post hoc analysis of data pooled from three randomized , placebo - and active-controlled , phase III studies of tapentadol ER for managing chronic osteoarthritis knee ( NCT00421928 , NCT00486811 ) or low back ( NCT00449176 ) pain ( 15-week , double-blind treatment period ) .
METHODS	Data were independently analyzed for patients with a listed medical history of hypertension at baseline and patients with at least one listed concomitant antihypertensive medication at baseline .
METHODS	Heart rate , systolic blood pressure ( SBP ) , and diastolic blood pressure ( DBP ) were measured at each visit .
RESULTS	In patients with a listed medical history of hypertension ( n = 1,464 ) , least-squares mean ( LSM [ standard error ( SE ) ] ) changes from baseline to endpoint with placebo , tapentadol ER , and oxycodone HCl controlled release ( CR ) , respectively , were -0.7 ( 0.44 ) , 0.2 ( 0.43 ) , and -0.9 ( 0.45 ) beats per minute ( bpm ) for heart rate ; -2.4 ( 0.64 ) , -2.7 ( 0.64 ) , and -3.7 ( 0.67 ) mmHg for SBP ; and -1.0 ( 0.39 ) , -1.3 ( 0.39 ) , and -2.3 ( 0.41 ) mmHg for DBP ; in patients with at least one listed concomitant antihypertensive medication ( n = 1,376 ) , the LSM ( SE ) changes from baseline to endpoint were -0.6 ( 0.45 ) , 0.1 ( 0.44 ) , and -0.7 ( 0.47 ) bpm for heart rate ; -1.8 ( 0.66 ) , -3.3 ( 0.65 ) , and -3.7 ( 0.69 ) mmHg for SBP ; and -0.7 ( 0.40 ) , -1.4 ( 0.40 ) , and -2.3 ( 0.42 ) mmHg for DBP .
CONCLUSIONS	No clinically meaningful mean changes in heart rate or blood pressure were observed for the evaluated cohorts of patients with hypertension who were treated with tapentadol ER ( 100-250 mg twice daily ) .

###24361086
OBJECTIVE	To assess the relative bioavailability of a new subcutaneous ( SC ) diclofenac hydroxypropyl b-cyclodextrin ( HPbCD ) formulation administered to three body sites : quadriceps , gluteus , and abdomen .
METHODS	This was a pilot , single-dose , randomized , three-way crossover relative bioavailability study .
METHODS	A total of 12 healthy subjects received a single SC injection of diclofenac HPbCD 50 mg/1 mL in the quadriceps , gluteus , or abdomen .
RESULTS	The AUC was comparable after SC diclofenac HPbCD in the quadriceps , gluteus , and abdomen .
RESULTS	The Cmax was comparable after SC administration in the quadriceps or abdomen , and ~ 17 % higher in the gluteus .
RESULTS	The absorption was rapid ( 30 minutes ) after administration of the treatment at any site .
RESULTS	The treatment was well tolerated .
CONCLUSIONS	The relative bioavailability of SC diclofenac HPbCD was comparable when administered to the quadriceps , gluteus , and abdomen .
CONCLUSIONS	The new diclofenac formulation can therefore be administered subcutaneously to any of these sites without clinically significant differences .
CONCLUSIONS	A further adequately powered study would be necessary to reveal any differences among injection sites in terms of peak plasma concentration .

###26142584
OBJECTIVE	To evaluate the correlation between the dosage frequency of sildenafil and its treatment outcomes in men with erectile dysfunction ( ED ) .
METHODS	Data were from a 4-week , multicenter , observational study of men ( 1699 ) , between 18 and 60 years of age , with a clinical diagnosis of ED defined as the Sexual Health Inventory for Men ( SHIM ) score 21 .
METHODS	The erectile function and quality of sexual life were evaluated at the baseline and the endpoint of sildenafil treatment ( after 4 weeks ) by using SHIM , Self-Esteem and Relationship Questionnaire , 36-Item Short Form Health Survey , Erection Hardness Score , and the global efficacy question .
RESULTS	Nine hundred thirty-five patients were enrolled in the 1 weekly , 573 in the 2-3 weekly , and 158 in the 4-7 weekly dosage frequency cohorts .
RESULTS	After 4 weeks of treatment , a higher dosage frequency of sildenafil was associated with a better SHIM , Self-Esteem and Relationship Questionnaire , and 36-Item Short Form Health Survey score improvement ( all P < .0001 ) .
RESULTS	Hyperlipidemia is a poor prognostic factor ( odds ratio , 3.59 ; P = .04 ) , whereas hypertension ( odds ratio , 0.25 ; P < .01 ) and coronary heart disease ( odds ratio , 0.56 ; P = .05 ) are sensitive to sildenafil treatment .
CONCLUSIONS	Higher dosage frequency of sildenafil is associated with a better improvement of sexual function and quality of life of men with ED , and the concomitant treatment of hyperlipidemia is recommended .

###24838660
OBJECTIVE	LigaSure , a bipolar electronic vessel sealing system , has become popular in abdominal surgery but few clinical studies have been conducted to evaluate its effectiveness in radical gastrectomy for gastric cancer .
METHODS	In this multicenter , prospective , randomized controlled trial , patients with curative gastric cancer were randomly assigned to undergo gastrectomy either with LigaSure or a conventional technique .
RESULTS	Of the 160 patients enrolled , 80 were randomized to the LigaSure group and 78 to the conventional group .
RESULTS	Patient characteristics were well balanced in the two groups .
RESULTS	There were no significant differences between the LigaSure and conventional groups in blood loss ( 288 vs. 260ml , respectively ; P = 0.748 ) or operative time ( 223 and 225min , respectively ; P = 0.368 ) ; nor in the incidence of surgical complications or duration of postoperative hospital stay .
RESULTS	In a subgroup analysis of patients who underwent gastrectomy that preserved the distal part of the greater omentum , the use of LigaSure significantly reduced blood loss ( 179 vs. 245ml ; P = 0.033 ) , and the duration of the operation ( 195 vs. 221min ; P = 0.039 ) .
CONCLUSIONS	LigaSure did not contribute to reducing intraoperative blood loss , operative time , or other adverse surgical outcomes .
CONCLUSIONS	The usefulness of the device may be limited to a specific part of the surgical procedure in open gastrectomy .

###24281386
BACKGROUND	Cerebral microbleeds have been observed in normal-appearing brain tissue of patients with glioma years after receiving radiation therapy .
BACKGROUND	The contrast of these paramagnetic lesions varies with field strength due to differences in the effects of susceptibility .
BACKGROUND	The purpose of this study was to compare 3T and 7T MRI as platforms for detecting cerebral microbleeds in patients treated with radiotherapy using susceptibility-weighted imaging ( SWI ) .
METHODS	SWI was performed with both 3T and 7T MR scanners on ten patients with glioma who had received prior radiotherapy .
METHODS	Imaging sequences were optimized to obtain data within a clinically acceptable scan time .
METHODS	Both T2 * - weighted magnitude images and SWI data were reconstructed , minimum intensity projection was implemented , and microbleeds were manually identified .
METHODS	The number of microbleeds was counted and compared among datasets .
RESULTS	Significantly more microbleeds were identified on SWI than magnitude images at both 7T ( p = 0.002 ) and 3T ( p = 0.023 ) .
RESULTS	Seven-tesla SWI detected significantly more microbleeds than 3T SWI for seven out of ten patients who had tumors located remote from deep brain regions ( p = 0.016 ) , but when the additional three patients with more inferior tumors were included , the difference was not significant .
CONCLUSIONS	SWI is more sensitive for detecting microbleeds than magnitude images at both 3T and 7T .
CONCLUSIONS	For areas without heightened susceptibility artifacts , 7T SWI is more sensitive to detecting radiation therapy-induced microbleeds than 3T SWI .
CONCLUSIONS	Tumor location should be considered in conjunction with field strength when selecting the most appropriate strategy for imaging microbleeds .

###24683774
OBJECTIVE	To assess the microflora of root canals in primary molars following use of rotary NiTi files and conventional hand NiTi and stainless steel files .
METHODS	This randomized clinical trial consisted of a total of 60 first and second primary molars requiring root canal treatment , who were selected from children aged 5-9 years .
METHODS	Based on type of root canal instrumentation , the teeth were randomly assigned to three groups of twenty teeth each ; Group A : Rotary NiTi files , Group B : Hand NiTi files and Group C : Hand stainless steel files .
METHODS	Following administration of local anesthesia , isolation with rubber dam was carried out .
METHODS	For the purpose of instrumentation and sampling , the palatal canal of maxillary molars and the distal canal of mandibular molars were selected .
METHODS	Prior to sampling , the orifices of other canals in these teeth were sealed , so as to prevent any contamination .
METHODS	Instrumentation was carried out in each group using respective instruments along with intermittent saline irrigation .
METHODS	Root canal samples were obtained both before and after instrumentation , using sterile absorbent paper points and transferred to a sterile vial with transport fluid .
METHODS	Serial dilutions were prepared and cultured on suitable agar media .
METHODS	Both aerobic and anaerobic microbial counts were made .
METHODS	Data obtained was subjected to statistical analysis using Wilcoxon signed rank test and one-way Analysis of variance .
RESULTS	In all three groups , there was a significant reduction in both aerobic and anaerobic mean microbial count following root canal instrumentation .
RESULTS	( p < 0.001 ) .
CONCLUSIONS	Rotary NiTi files were as efficient as conventional hand instruments in significantly reducing the root canal microflora .

###25898050
OBJECTIVE	Disruptive behavior is common in children with autism spectrum disorder .
OBJECTIVE	Behavioral interventions are used to treat disruptive behavior but have not been evaluated in large-scale randomized trials .
OBJECTIVE	To evaluate the efficacy of parent training for children with autism spectrum disorder and disruptive behavior .
METHODS	This 24-week randomized trial compared parent training ( n = 89 ) to parent education ( n = 91 ) at 6 centers ( Emory University , Indiana University , Ohio State University , University of Pittsburgh , University of Rochester , Yale University ) .
METHODS	We screened 267 children ; 180 children ( aged 3-7 years ) with autism spectrum disorder and disruptive behaviors were randomly assigned ( 86 % white , 88 % male ) between September 2010 and February 2014 .
METHODS	Parent training ( 11 core , 2 optional sessions ; 2 telephone boosters ; 2 home visits ) provided specific strategies to manage disruptive behavior .
METHODS	Parent education ( 12 core sessions , 1 home visit ) provided information about autism but no behavior management strategies .
METHODS	Parents rated disruptive behavior and noncompliance on co-primary outcomes : the Aberrant Behavior Checklist-Irritability subscale ( range , 0-45 ) and the Home Situations Questionnaire-Autism Spectrum Disorder ( range , 0-9 ) .
METHODS	On both measures , higher scores indicate greater severity and a 25 % reduction indicates clinical improvement .
METHODS	A clinician blind to treatment assignment rated the Improvement scale of the Clinical Global Impression ( range , 1-7 ) , a secondary outcome , with a positive response less than 3 .
RESULTS	At week 24 , the Aberrant Behavior Checklist-Irritability subscale declined 47.7 % in parent training ( from 23.7 to 12.4 ) compared with 31.8 % for parent education ( 23.9 to 16.3 ) ( treatment effect , -3.9 ; 95 % CI , -6.2 to -1.7 ; P < .001 , standardized effect size = 0.62 ) .
RESULTS	The Home Situations Questionnaire-Autism Spectrum Disorder declined 55 % ( from 4.0 to 1.8 ) compared with 34.2 % in parent education ( 3.8 to 2.5 ) ( treatment effect , -0.7 ; 95 % CI , -1.1 to -0.3 ; P < .001 , standardized effect size = 0.45 ) .
RESULTS	Neither measure met the prespecified minimal clinically important difference .
RESULTS	The proportions with a positive response on the Clinical Global Impression-Improvement scale were 68.5 % for parent training vs 39.6 % for parent education ( P < .001 ) .
CONCLUSIONS	For children with autism spectrum disorder , a 24-week parent training program was superior to parent education for reducing disruptive behavior on parent-reported outcomes , although the clinical significance of the improvement is unclear .
CONCLUSIONS	The rate of positive response judged by a blinded clinician was greater for parent training vs parent education .
BACKGROUND	clinicaltrials.gov Identifier : NCT01233414 .

###25066102
BACKGROUND	As relapse after completed cognitive behavior therapy ( CBT ) for obsessive-compulsive disorder ( OCD ) is common , many treatment protocols include booster programs to improve the long-term effects .
BACKGROUND	However , the effects of booster programs are not well studied .
BACKGROUND	In this study , we investigated the long-term efficacy of Internet-based CBT ( ICBT ) with therapist support for OCD with or without an Internet-based booster program .
METHODS	A total of 101 participants were included in the long-term follow-up analysis of ICBT .
METHODS	Of these , 93 were randomized to a booster program or no booster program .
METHODS	Outcome assessments were collected at 4 , 7 , 12 and 24 months after receiving ICBT .
RESULTS	The entire sample had sustained long-term effects from pre-treatment to all follow-up assessments , with large within-group effect sizes ( Cohen 's d = 1.58-2 .09 ) .
RESULTS	The booster group had a significant mean reduction in OCD symptoms compared to the control condition from booster baseline ( 4 months ) to 7 months , but not at 12 or 24 months .
RESULTS	Participants in the booster group improved significantly in terms of general functioning at 7 , 12 and 24 months , and had fewer relapses .
RESULTS	Kaplan-Meier analysis also indicated a significantly slower relapse rate in the booster group .
CONCLUSIONS	The results suggest that ICBT has sustained long-term effects and that adding an Internet-based booster program can further improve long-term outcome and prevent relapse for some OCD patients .

###24662192
BACKGROUND	Data from an open label randomised controlled trial have suggested possible advantages on both motor and non-motor measures in patients with Parkinson 's disease following 12 months exposure to exenatide .
OBJECTIVE	Continued follow up of these same patients was performed to investigate whether these possible advantages persisted in the prolonged absence of this medication .
METHODS	All participants from an open label , randomised controlled trial of exenatide as a treatment for Parkinson 's disease , were invited for a further follow up assessment at the UCL Institute of Neurology .
METHODS	This visit included all 20 individuals who had previously completed twelve months exposure to exenatide 10ug bd and the 24 individuals who had acted as randomised controls .
METHODS	Motor severity of PD was compared after overnight withdrawal of conventional PD medication using blinded video assessment of the MDS-UPDRS , together with several non-motor tests .
METHODS	This assessment was thus 24 months after their original baseline visit , i.e. 12 months after cessation of exenatide .
RESULTS	Compared to the control group of patients , patients previously exposed to exenatide had an advantage of 5.6 points ( 95 % CI , 2.2-9 .0 ; p = 0.002 ) using blinded video rating of the MDS-UPDRS part 3 motor subscale .
RESULTS	There was also a difference of 5.3 points ; ( 95 % CI , 9.3-1 .4 ; p = 0.006 ) between the 2 groups on the Mattis Dementia Rating scale .
CONCLUSIONS	While these data must still not be interpreted as evidence of neuroprotection , they nevertheless provide strong encouragement for the further study of this drug as a potential disease modifying agent in Parkinson 's disease .

###25567068
OBJECTIVE	The Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation ( MANTRA-PAF ) trial assessed the long-term efficacy of an initial strategy of radiofrequency ablation ( RFA ) vs. antiarrhythmic drug therapy ( AAD ) as first-line treatment for patients with PAF .
OBJECTIVE	In this substudy , we evaluated the effect of these treatment modalities on the Health-Related Quality of Life ( HRQoL ) and symptom burden of patients at 12 and 24 months .
RESULTS	During the study period , 294 patients were enrolled in the MANTRA-PAF trial and randomized to receive AAD ( N = 148 ) or RFA ( N = 146 ) .
RESULTS	Two generic questionnaires were used to assess the HRQoL [ Short Form-36 ( SF-36 ) and EuroQol-five dimensions ( EQ-5D ) ] , and the Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia ( ASTA ) was used to evaluate the symptoms appearing during the trial .
RESULTS	All comparisons were made on an intention-to-treat basis .
RESULTS	Both randomization groups showed significant improvements in assessments with both SF-36 and EQ-5D , at 24 months .
RESULTS	Patients randomized to RFA showed significantly greater improvement in four physically related scales of the SF-36 .
RESULTS	The three most frequently reported symptoms were breathlessness during activity , pronounced tiredness , and worry/anxiety .
RESULTS	In both groups , there was a significant reduction in ASTA symptom index and in the severity of seven of the eight symptoms over time .
CONCLUSIONS	Both AAD and RFA as first-line treatment resulted in substantial improvement of HRQoL and symptom burden in patients with PAF .
CONCLUSIONS	Patients randomized to RFA showed greater improvement in physical scales ( SF-36 ) and the EQ-visual analogue scale .
BACKGROUND	URL http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00133211 .

###24318457
OBJECTIVE	To establish the efficiency of bowel ligatures in colon cancer surgery , focusing on the extent to which exfoliated cancer cells are shed in the colonic lumen during sigmoidectomy .
METHODS	Twenty consecutive patients who underwent sigmoidectomy for sigmoid colon cancer were prospectively randomized into two groups : the `` ligatures group '' , in which bowel ligatures were placed , 3 , 5 , 10 cm from the tumor proximally and distally before dissection ; and the `` no ligatures group '' , in which the corresponding sites were ligated only immediately before taking the specimen out .
METHODS	Each colonic segment ligated was irrigated with saline and samples were sent for blind cytological examination .
RESULTS	Cancer cells were found in the colonic segment where the tumor was located , in 18 of 20 samples .
RESULTS	The frequency of free cancer cells decreased from 50 to 0 % ( p < 0.04 ) in the distal 3-5 cm colonic segment and from 80 to 20 % ( p < 0.03 ) in the proximal colonic segment after performing bowel ligatures .
RESULTS	Free cancer cells were confirmed in 1 of 10 samples at both colonic segments 5-10 cm from the tumor , even after bowel ligatures .
CONCLUSIONS	Intraluminal exfoliated cancer cells could be eliminated by placing bowel ligatures during sigmoidectomy .
CONCLUSIONS	Measures should be considered to eliminate exfoliated cancer cells during colectomy , even after placing bowel ligatures .

###25537197
OBJECTIVE	To compare postoperative visual symptoms and spectacle freedom after bilateral implantation of the AT LISA 809M ( Carl Zeiss Meditec , Jena , Germany ) versus the AcrySof ReSTOR SN6AD1 ( Alcon Laboratories , Irvine , CA ) multifocal intraocular lens ( IOL ) .
METHODS	Double-masked , prospective , randomized , controlled clinical trial .
METHODS	A total of 188 patients undergoing bilateral sequential cataract surgery or bilateral refractive lens exchange .
METHODS	Patients were preoperatively randomized ( allocation ratio 1:1 ) to bilateral implantation with the AT LISA 809M IOL or ReSTOR SN6AD1 IOL .
METHODS	Postoperative outcomes were assessed 4 to 8 months after second eye surgery .
METHODS	The primary outcome was visual symptoms evaluated with the Quality of Vision ( QoV ) questionnaire .
METHODS	Secondary outcomes included other questionnaire data ( CatQuest-9SF , spectacle independence , vision satisfaction , and dysphotopsia ) and visual function measures ( near , intermediate , and distance visual acuity , binocular reading speed [ International Reading Speed Texts ] , contrast sensitivity , and forward light scatter ) .
METHODS	Adverse events , including intraoperative and postoperative complications , also were evaluated .
RESULTS	There was no significant difference between IOL groups in Rasch-adjusted QoV scores for frequency ( P = 0.95 ) , severity ( P = 0.56 ) , and bothersomeness ( P = 0.34 ) of visual symptoms ; median ( interquartile ) scores for these QoV subscales were 29 ( 15-37 ) , 22 ( 13-27 ) , and 14 ( 0-29 ) for the AT LISA 809M IOL group , respectively , and 32 ( 15-37 ) , 22 ( 13-30 ) , and 14 ( 0-29 ) for the ReSTOR SN6AD1 IOL group , respectively .
RESULTS	Halo was the most prominent dysphotopsia symptom , with 6 % in both IOL groups reporting halo symptoms as very bothersome .
RESULTS	Complete spectacle independence was achieved in 69 of 84 ( 82.1 % ) AT LISA 809M recipients and 66 of 85 ( 77.6 % ) ReSTOR SN6AD1 recipients ( P = 0.57 ) .
RESULTS	Preferred reading distance was slightly nearer for the AT LISA 809M IOL .
RESULTS	There were no statistically significant differences in any of the other secondary outcome measures .
CONCLUSIONS	Visual symptoms were similar after bilateral implantation of the AT LISA 809M and ReSTOR SN6AD1 IOLs .
CONCLUSIONS	Both these diffractive bifocal IOLs produce high levels of spectacle independence and patient satisfaction .
CONCLUSIONS	However , a small but clinically significant minority of patients remained symptomatic and dissatisfied with visual results 4 to 8 months after surgery .

###24813819
BACKGROUND	Little is known about how colorectal cancer screening test preferences operate together with test access and navigation to influence screening adherence in primary care .
METHODS	We analyzed data from a randomized trial of 945 primary care patients to assess the independent effects of screening test preference for fecal immunochemical test ( FIT ) or colonoscopy , mailed access to FIT and colonoscopy , and telephone navigation for FIT and colonoscopy , on screening .
RESULTS	Preference was not associated with overall screening , but individuals who preferred FIT were more likely to complete FIT screening ( P = 0.005 ) , whereas those who preferred colonoscopy were more likely to perform colonoscopy screening ( P = 0.032 ) .
RESULTS	Mailed access to FIT and colonoscopy was associated with increased overall screening ( OR = 2.6 , P = 0.001 ) , due to a 29-fold increase in FIT use .
RESULTS	Telephone navigation was also associated with increased overall screening ( OR = 2.1 , P = 0.005 ) , mainly due to a 3-fold increase in colonoscopy performance .
RESULTS	We estimated that providing access and navigation for both screening tests may substantially increase screening compared with a preference-tailored approach , mainly due to increased performance of nonpreferred tests .
CONCLUSIONS	Preference influences the type of screening tests completed .
CONCLUSIONS	Test access increases FIT and navigation mainly increases colonoscopy .
CONCLUSIONS	Screening strategies providing access and navigation to both tests may be more effective than preference-tailored approaches .
CONCLUSIONS	Preference tailoring in colorectal cancer screening strategies should be avoided if the objective is to maximize screening rates , although other factors ( e.g. , costs , necessary follow-up ) should also be considered .

###24499010
BACKGROUND	Appropriate sedation benefits patients by reducing the stress response , but it requires an appropriate method of assessment to adjust the dosage of sedatives .
BACKGROUND	The aim of this study was to compare the difference in the sedation of mechanically ventilated patients undergoing flexible bronchoscopy ( FB ) monitored by auditory-evoked potentials ( AEPs ) or the Ramsay sedation scale ( RSS ) .
METHODS	In a prospective , randomized , controlled study , all patients who underwent FB with propofol sedation were monitored and their sedation adjusted .
METHODS	During FB , one group was monitored by AEP and another group was monitored by RSS .
METHODS	The propofol dosage was adjusted by the nursing staff during examination to maintain the Alaris AEP index ( AAI ) value between 25 and 40 in the AEP group and the RSS at 5 or 6 in the RSS group .
METHODS	Before FB and during FB , the AAI , heart rate ( HR ) , and mean arterial pressure ( MAP ) were recorded every 5 min .
METHODS	The percentages of time at the sedation target and the propofol dosages were calculated .
RESULTS	Nineteen patients received AEP monitoring and 18 patients received RSS monitoring .
RESULTS	The percentage of time at the sedation target during FB was significantly higher in the AEP monitoring group ( 51.3 % ; interquartile range [ IQR ] , 47.0-63 .5 % ) than in the RSS group ( 15.4 % ; IQR , 9.5-23 .4 % ) , ( P < 0.001 ) .
RESULTS	During FB , the RSS group had a significantly higher AAI ( P = 0.011 ) , HR ( P < 0.001 ) , and MAP ( P < 0.001 ) than the AEP group .
CONCLUSIONS	In mechanically ventilated patients undergoing FB , AEP monitoring resulted in less variation in AAI , HR , and MAP , and a higher percentage of time at the sedation target than RSS monitoring .

###25425434
BACKGROUND	Given increasing rates of resistance to existing therapy , new options for treatment and prophylaxis of malaria are needed .
METHODS	Two randomised , comparative , non-inferiority studies were conducted in Africa , one double-blinded and one open-label .
METHODS	Adults with fever , a positive peripheral blood smear , and a positive rapid diagnostic test for Plasmodium falciparum were randomised in both studies to either azithromycin ( AZ ) 1,000 mg plus chloroquine ( CQ ) 600-mg base ( AZCQ 1,000 mg ) once daily for three days or mefloquine hydrochloride ( MQ ) 1,250 mg ( split dose ) .
METHODS	In the first study , an additional regimen of AZ 500 mg plus CQ 600-mg base ( AZCQ 500 mg ) once daily for three days was included .
METHODS	All study participants were hospitalised until three consecutive daily blood smears were negative for asexual P. falciparum parasitaemia .
METHODS	Study participants were evaluated weekly for 42 days , with Day 28 polymerase chain reaction ( PCR ) - corrected parasitological clearance rate as primary endpoint .
RESULTS	A total of 467 subjects were randomised in the two studies .
RESULTS	At 28 days ' follow-up , PCR-corrected parasitological clearance rates in the per protocol population in the first study were 101/103 ( 98 % ) with AZCQ 1,000 mg compared with 102/103 ( 99 % ) with MQ ( 95 % confidence interval [ CI ] : -5.2 , 3.3 ) .
RESULTS	The AZCQ 500-mg regimen was stopped during an interim study review ( six [ 86 % ] clearance of seven evaluable ; two lost to follow-up ) .
RESULTS	In the second study , clearance rates were similar : AZCQ 1,000 mg 107/107 ( 100 % ) vs MQ 111/112 ( 99 % ; 95 % CI : -1.8 , 3.6 ) .
RESULTS	Among the participating countries , in vitro CQ resistance based on pfcrt mutation frequency in the baseline isolates across both studies ranged from 20.8 % ( Zambia ) to 96.1 % ( Uganda ) .
RESULTS	Serious adverse events ( AEs ; all causality ) were observed more frequently with MQ compared with AZCQ ( four vs one , respectively ) , though discontinuations for AEs were similar ( four vs three , respectively ) .
RESULTS	Common AEs in the AZ-containing arms included pruritus , vomiting , dizziness , and headache .
CONCLUSIONS	Among adults with symptomatic uncomplicated falciparum malaria in Africa , the combination of AZ 1,000 mg and CQ 600-mg base once daily for three days resulted in Day 28 PCR-corrected parasitological clearance rates of 98 % and was non-inferior to treatment with MQ .
CONCLUSIONS	AZCQ was well tolerated .
BACKGROUND	ClinicalTrials.gov identifiers NCT00082576 and NCT00367653 .

###24411639
BACKGROUND	The phase 3 LUME-Lung 1 study assessed the efficacy and safety of docetaxel plus nintedanib as second-line therapy for non-small-cell lung cancer ( NSCLC ) .
METHODS	Patients from 211 centres in 27 countries with stage IIIB/IV recurrent NSCLC progressing after first-line chemotherapy , stratified by ECOG performance status , previous bevacizumab treatment , histology , and presence of brain metastases , were allocated ( by computer-generated sequence through an interactive third-party system , in 1:1 ratio ) , to receive docetaxel 75 mg/m ( 2 ) by intravenous infusion on day 1 plus either nintedanib 200 mg orally twice daily or matching placebo on days 2-21 , every 3 weeks until unacceptable adverse events or disease progression .
METHODS	Investigators and patients were masked to assignment .
METHODS	The primary endpoint was progression-free survival ( PFS ) by independent central review , analysed by intention to treat after 714 events in all patients .
METHODS	The key secondary endpoint was overall survival , analysed by intention to treat after 1121 events had occurred , in a prespecified stepwise order : first in patients with adenocarcinoma who progressed within 9 months after start of first-line therapy , then in all patients with adenocarcinoma , then in all patients .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00805194 .
RESULTS	Between Dec 23 , 2008 , and Feb 9 , 2011 , 655 patients were randomly assigned to receive docetaxel plus nintedanib and 659 to receive docetaxel plus placebo .
RESULTS	The primary analysis was done after a median follow-up of 71 months ( IQR 38-110 ) .
RESULTS	PFS was significantly improved in the docetaxel plus nintedanib group compared with the docetaxel plus placebo group ( median 34 months [ 95 % CI 29-39 ] vs 27 months [ 26-28 ] ; hazard ratio [ HR ] 079 [ 95 % CI 068-092 ] , p = 00019 ) .
RESULTS	After a median follow-up of 317 months ( IQR 278-361 ) , overall survival was significantly improved for patients with adenocarcinoma histology who progressed within 9 months after start of first-line treatment in the docetaxel plus nintedanib group ( 206 patients ) compared with those in the docetaxel plus placebo group ( 199 patients ; median 109 months [ 95 % CI 85-126 ] vs 79 months [ 67-91 ] ; HR 075 [ 95 % CI 060-092 ] , p = 00073 ) .
RESULTS	Similar results were noted for all patients with adenocarcinoma histology ( 322 patients in the docetaxel plus nintedanib group and 336 in the docetaxel plus placebo group ; median overall survival 126 months [ 95 % CI 106-151 ] vs 103 months [ 95 % CI 86-122 ] ; HR 083 [ 95 % CI 070-099 ] , p = 00359 ) , but not in the total study population ( median 101 months [ 95 % CI 88-112 ] vs 91 months [ 84-104 ] ; HR 094 , 95 % CI 083-105 , p = 02720 ) .
RESULTS	Grade 3 or worse adverse events that were more common in the docetaxel plus nintedanib group than in the docetaxel plus placebo group were diarrhoea ( 43 [ 66 % ] of 652 vs 17 [ 26 % ] of 655 ) , reversible increases in alanine aminotransferase ( 51 [ 78 % ] vs six [ 09 % ] ) , and reversible increases in aspartate aminotransferase ( 22 [ 34 % ] vs three [ 05 % ] ) .
RESULTS	35 patients in the docetaxel plus nintedanib group and 25 in the docetaxel plus placebo group died of adverse events possibly unrelated to disease progression ; the most common of these events were sepsis ( five with docetaxel plus nintedanib vs one with docetaxel plus placebo ) , pneumonia ( two vs seven ) , respiratory failure ( four vs none ) , and pulmonary embolism ( none vs three ) .
CONCLUSIONS	Nintedanib in combination with docetaxel is an effective second-line option for patients with advanced NSCLC previously treated with one line of platinum-based therapy , especially for patients with adenocarcinoma .
BACKGROUND	Boehringer Ingelheim .

###24617731
OBJECTIVE	To investigate the effects of cell therapy on myocardial perfusion recovery after treatment of acute myocardial infarction ( MI ) with primary percutaneous coronary intervention ( PCI ) .
METHODS	In this HEBE trial substudy , which was approved by the institutional review board ( trial registry number ISRCTN95796863 ) , the authors assessed the effects of intracoronary infusion with bone marrow-derived mononuclear cells ( BMMCs ) or peripheral blood-derived mononuclear cells ( PBMCs ) on myocardial perfusion recovery by using cardiac magnetic resonance ( MR ) imaging after revascularization .
METHODS	In 152 patients with acute MI treated with PCI , cardiac MR imaging was performed after obtaining informed consent-before randomization to BMMC , PBMC , or standard therapy ( control group ) - and repeated at 4-month follow-up .
METHODS	Cardiac MR imaging consisted of cine , rest first-pass perfusion , and late gadolinium enhancement imaging .
METHODS	Perfusion was evaluated semiquantitatively with signal intensity-time curves by calculating the relative upslope ( percentage signal intensity change ) .
METHODS	The relative upslope was calculated for the MI core , adjacent border zone , and remote myocardium .
METHODS	Perfusion differences among treatment groups or between baseline and follow-up were assessed with the Wilcoxon signed rank or Mann-Whitney U test .
RESULTS	At baseline , myocardial perfusion differed between the MI core ( median , 6.0 % ; interquartile range [ IQR ] , 4.1 % -8.0 % ) , border zone ( median , 8.4 % ; IQR , 6.4 % -10.2 % ) , and remote myocardium ( median , 12.2 % ; IQR , 10.5 % -15.9 % ) ( P < .001 for all ) , with equal distribution among treatment groups .
RESULTS	These interregional differences persisted at follow-up ( P < .001 for all ) .
RESULTS	No difference in perfusion recovery was found between the three treatment groups for any region .
CONCLUSIONS	After revascularization of ST-elevation MI , cell therapy does not augment the recovery of resting perfusion in either the MI core or border zone .

###24895719
BACKGROUND	The prevalence of Chronic Heart Failure ( CHF ) in Spain is very high .
BACKGROUND	It is the main cause of many hospital admissions and it is associated with high mortality rates .
BACKGROUND	Its management in Primary Care is not always adequate .
BACKGROUND	Our objective was to evaluate whether an educational intervention in general practitioners would improve the health care of their patients with chronic heart failure .
METHODS	Prospective , randomised , and controlled study .
METHODS	A structured formative course was given to the intervention group ( IG ) of practitioners .
METHODS	A year later changes were compared with a control group ( CG ) .
METHODS	The settings were two Primary Care Centres .
METHODS	One of them was in a rural setting , and the other one with a mixture of rural and urban populations .
METHODS	The study included 185 patients diagnosed with CHF , with a mean age of 79.8 years , and they were assigned to 20 practitioners ( Total population : 15 , 921 ) We evaluated the quality of medical history , clinical examination , laboratory tests and treatment .
RESULTS	At the end of the study there were marked differences between both groups .
RESULTS	In the IG , the Medical History improved 1.42 points ( 95 % CI : 0.57 to 2.28 ) , P = .001 .
RESULTS	The Clinical Examination improved 2.37 points ( 95 % CI : 1.10 to 3.65 ) , P > .001 and the Laboratory Tests , 0.75 points ( 95 % CI : -0.15 to 1.66 ) , P = .10 ; The Overall Difference was 5.44 points ( 95 % Cl : 3.25 to 7.62 ) , P > .001 .
RESULTS	There were slight improvements in Treatment .
CONCLUSIONS	The intervention promoted from our own work settings achieved a general improvement in the care of patients with heart failure .

###25566589
OBJECTIVE	To compare the effects of hyperbaric and isobaric bupivacaine spinal anesthesia on hemodynamics and heart rate variability ( HRV ) in nonobstetric surgery .
METHODS	Sixty patients were randomly allocated to 2 groups .
METHODS	Group I ( n = 30 ) received 15 mg ( 3 mL ) of hyperbaric bupivacaine and Group II ( n = 30 ) received 15 mg ( 3 mL ) of isobaric bupivacaine for spinal anesthesia .
METHODS	Hemodynamic parameters were recorded before and after spinal anesthesia over 30 min .
METHODS	Analyses of HRV were performed on the day of surgery , after volume loading , and 20 min after spinal injection .
METHODS	Low frequency ( LF ) values , high frequency ( HF ) values , and LF/HF ratios were recorded .
METHODS	The incidences of hypotension and alterations of HRV parameters in both groups were investigated .
RESULTS	The incidence ofhypotension was 26.6 % and 23.3 % in Groups I and II , respectively .
RESULTS	There were no significant differences in the LF and HF values and LF/HF ratios between groups .
RESULTS	In Group I , LF/HF ratios were significantly lower and HF values were significantly higher at 20 min after spinal anesthesia , in comparison to the baseline value ( P < 0.05 ) .
CONCLUSIONS	Hyperbaric bupivacaine caused a significantly greater decrease in LF/HF ratios and a significantly greater increase in HF values .

###25993386
BACKGROUND	An association between relatively deep anesthesia , as guided by the bispectral index ( BIS ) , and increased postoperative mortality has been demonstrated in 6 of 8 published observational studies , but association does not necessarily mean causality .
BACKGROUND	Small clinical trials of anesthetic depth have demonstrated increased delirium and postoperative cognitive dysfunction in patients who were relatively deeply anesthetized , but have been inadequately powered to study mortality .
BACKGROUND	A large-scale randomized study is required to determine whether causality exists .
METHODS	The primary hypothesis of our study is that `` light '' anesthesia , defined as a BIS target of 50 , will reduce all-cause mortality within 1 year of surgery in comparison with `` deep '' anesthesia , defined as a BIS target of 35 , in patients aged 60 years presenting for major surgery under general anesthesia .
METHODS	The trial is an international multicenter , randomized , parallel-group , double-blind ( patients and investigators ) prospective , intention-to-treat , safety and efficacy study .
METHODS	The relative reduction in mortality in the light anesthesia group is expected to be 20 % , giving an absolute risk reduction from 10 % to 8 % .
METHODS	Power analysis using a = 0.049 and b = 0.2 indicates that 3250 patients are required in each group .
RESULTS	The study is underway , and 1325 patients have been recruited in 40 centers in 5 countries .
RESULTS	It is anticipated that the study will be completed in 3 years .
CONCLUSIONS	This randomized controlled trial should definitively answer the question of whether titrating anesthetic depth makes a difference to patient outcome in a vulnerable patient group .

###24751581
OBJECTIVE	The benefits of narrow band imaging ( NBI ) on enhancing colorectal adenoma detection remain questionable .
OBJECTIVE	We tested whether the new generation of NBI ( 190-NBI ) , which is twice as bright as the previous version , would improve adenoma detection when compared with high-definition white light ( HD-WL ) colonoscopy .
METHODS	It was a randomized controlled trial with tandem colonoscopy .
METHODS	We recruited patients who underwent colonoscopy for symptoms , screening , or surveillance .
METHODS	Patients were randomized for the use of either 190-NBI or HD-WL on withdrawal .
METHODS	Tandem colonoscopy was performed by using the same assigned colonoscope and withdrawal method .
METHODS	Lesions detected on first-pass and second-pass examination were used for adenoma detection and miss rates , respectively .
METHODS	The primary outcomes were adenoma and polyp detection rates .
RESULTS	A total of 360 patients were randomized to undergo either 190-NBI or HD-WL colonoscopy .
RESULTS	Both the adenoma and polyp detection rates were significantly higher in the 190-NBI group compared with the HD-WL group ( adenoma : 48.3 % vs. 34.4 % , P = 0.01 ; polyps : 61.1 % vs. 48.3 % , P = 0.02 ) .
RESULTS	The mean number of polyps detected per patient was higher in the 190-NBI group ( 1.49 % vs. 1.13 , P = 0.07 ) .
RESULTS	There was no significant difference in the adenoma miss rates between the two groups ( 21.8 % vs. 21.2 % ) .
RESULTS	Multivariate analysis showed that the use of 190-NBI ( odds ratio ( OR ) 1.85 ; 95 % confidence interval ( CI ) 1.10-3 .12 ) , withdrawal time ( OR 1.29 ; CI 1.19-1 .38 ) , patient 's age ( OR 1.04 ; CI 1.01-1 .06 ) , and male gender ( OR 2.38 ; CI 1.42-3 .99 ) were associated with adenoma detection .
CONCLUSIONS	190-NBI colonoscopy was superior to the conventional HD-WL in detecting colorectal adenomas or polyps , but there was no significant difference in adenoma miss rates .

###25185252
OBJECTIVE	To compare the success rates of probing versus bicanalicular silastic intubation as the primary treatment for congenital nasolacrimal duct obstruction ( CNLDO ) in children 1year old .
METHODS	Prospective , randomised , comparison .
METHODS	Participants were randomised to undergo probing or bicanalicular silastic intubation .
METHODS	In bilateral cases , the right eye was used for analysis .
METHODS	The procedure was considered successful when all preoperative manifestations disappeared with normal dye disappearance test and a positive Jones primary dye test at least 6months postoperatively .
METHODS	Secondary outcomes were risk factors for failure .
METHODS	Outcomes were compared between treatments with p < 0.05 indicating statistical significance .
RESULTS	207 eyes of 181 children between 1 and 8years old with CNLDO who had not undergone previous surgical treatment were included in the study .
RESULTS	88 eyes underwent probing with a 84.1 % success rate and 93 eyes that underwent bicanalicular silastic intubation had a 89.2 % success rate ( p = 0.429 ) .
RESULTS	For simple CNLDO , there was a 94.2 % ( 65/69 ) success rate with probing and a 90.9 % ( 60/66 ) success rate with bicanalicular silastic intubation ( p = 0.687 ) .
RESULTS	In complex CNLDO , there was a 47.4 % ( 9/19 ; p = < 0.001 ) success rate with probing and an 85.2 % ( 23/27 ; p = 0.419 ) success rate with silastic intubation ( p = 0.016 ) .
RESULTS	Age was not a risk factor for failure in either procedure .
CONCLUSIONS	Probing for simple CNLDO in young children is adequate .
CONCLUSIONS	Bicanalicular silastic intubation seems to have a role in achieving successful outcomes in complex CNLDO .

###25918334
BACKGROUND	Despite recommendations against systematic screening for prostate cancer , 70 % of patients still request prostate-specific antigen testing .
OBJECTIVE	To assess the impact of a decision aid on patients ' intention to undergo prostate cancer screening .
METHODS	Randomised controlled trial with two-arm parallel groups in 86 general practices in urban and rural areas in France .
METHODS	Males aged 50-75 years were randomised to receive either the decision aid ( intervention group ) or usual care ( control group ) .
METHODS	The primary outcome was the proportion of patients ' intending to undergo prostate cancer screening , assessed immediately after reading the decision aid .
METHODS	The reasons underlying their choice were elicited and the proportion of patients citing each reason to undergo , or not undergo , prostate cancer screening were compared between the two arms .
RESULTS	A total of 1170 patients were randomised ( 588 in the intervention arm ) from November 2012 to February 2013 .
RESULTS	The proportion of patients who intended to be tested for prostate cancer in the intervention arm ( 123 patients [ 20.9 % ] ) was significantly reduced compared with the control arm ( 57 patients [ 9.8 % ] ) ( difference 11.1 % , 95 % confidence interval [ CI ] = 7.0 to 15.2 , P < 0.0001 ) .
RESULTS	In the intervention group , a lower proportion of individuals expressed that cancer screening would protect them from the disease , compared with the control group ( P < 0.0001 ) , while a greater proportion of individuals stated that prostate cancer screening would not benefit their health ( P < 0.0001 ) and may involve procedures with harmful side effects ( P = 0.0005 ) .
CONCLUSIONS	The decision aid improved participants ' informed decision making and reduced their intent to undergo prostate cancer screening .

###24316325
OBJECTIVE	To examine if supported employment ( SE ) remains more effective than treatment as usual ( TAU ) in returning veterans to competitive employment after spinal cord injury ( SCI ) at 2-year follow-up .
METHODS	Prospective , randomized , controlled , multisite trial of SE versus TAU with 24 months of follow-up .
METHODS	SCI centers .
METHODS	Subjects ( N = 201 ) were enrolled and completed baseline interviews .
METHODS	At interventional sites , subjects were randomized to SE ( n = 81 ) or TAU ( n = 76 ) .
METHODS	At observational sites , 44 subjects were enrolled in a nonrandomized TAU condition .
METHODS	The intervention was a SE program called the SCI Vocational Integration Program , which followed the principles of the individual placement and support model of SE for persons with mental illness .
METHODS	Competitive employment in the community within 2 years .
RESULTS	For the entire 2-year follow-up period , SE subjects were significantly more likely to achieve employment ( 30.8 % ; 95 % confidence interval [ CI ] , 21.8-41 .6 ) than either the TAU subjects at the intervention sites ( 10.5 % ; 95 % CI , 5.2-19 .7 ; P < .001 ) or the TAU subjects at the observational sites ( 2.3 % ; 95 % CI , 0.0-12 .9 ; P < .002 ) .
RESULTS	Most subjects who obtained competitive employment did so in year 1 , and the average time to first employment was about 17 weeks .
CONCLUSIONS	SE was better than usual practices in improving employment outcomes for veterans with SCI across a 2-year follow-up period .
CONCLUSIONS	Although SE continued to be superior to traditional practices over the entire study , the first year of participation in SE may represent a critical window for achieving employment after SCI .

###25671024
BACKGROUND	Our objective was to evaluate the effectiveness of hands-on training at a bedside ultrasound ( US ) symposium ( `` Ultrafest '' ) to improve both clinical knowledge and image acquisition skills of medical students .
BACKGROUND	Primary outcome measure was improvement in multiple choice questions on pulmonary or Focused Assessment with Sonography in Trauma ( FAST ) US knowledge .
BACKGROUND	Secondary outcome was improvement in image acquisition for either pulmonary or FAST .
METHODS	Prospective cohort study of 48 volunteers at `` Ultrafest , '' a free symposium where students received five contact training hours .
METHODS	Students were evaluated before and after training for proficiency in either pulmonary US or FAST .
METHODS	Proficiency was assessed by clinical knowledge through written multiple-choice exam , and clinical skills through accuracy of image acquisition .
METHODS	We used paired sample t-tests with students as their own controls .
RESULTS	Pulmonary knowledge scores increased by a mean of 10.1 points ( 95 % CI [ 8.9-11 .3 ] , p < 0.00005 ) , from 8.4 to a posttest average of 18.5 / 21 possible points .
RESULTS	The FAST knowledge scores increased by a mean of 7.5 points ( 95 % CI [ 6.3-8 .7 ] p < 0.00005 ) , from 8.1 to a posttest average of 15.6 / 21 .
RESULTS	We analyzed clinical skills data on 32 students .
RESULTS	The mean score was 1.7 pretest and 4.7 posttest of 12 possible points .
RESULTS	Mean improvement was 3.0 points ( p < 0.00005 ) overall , 3.3 ( p = 0.0001 ) for FAST , and 2.6 ( p = 0.003 ) for the pulmonary US exam .
CONCLUSIONS	This study suggests that a symposium on US can improve clinical knowledge , but is limited in achieving image acquisition for pulmonary and FAST US assessments .
CONCLUSIONS	US training external to official medical school curriculum may augment students ' education .

###24930625
BACKGROUND	To evaluate the efficacy and safety of ramucirumab ( IMC-1121B ; LY3009806 ) , a fully human monoclonal antibody targeting the vascular endothelial growth factor receptor-2 , alone and in combination with dacarbazine in chemotherapy-nave patients with metastatic melanoma ( MM ) .
METHODS	Eligible patients received ramucirumab ( 10mg/kg ) + dacarbazine ( 1000 mg/m ( 2 ) ) ( Arm A ) or ramucirumab only ( 10mg/kg ) ( Arm B ) every 3 weeks .
METHODS	The primary end-point was progression-free survival ( PFS ) ; secondary end-points included overall survival ( OS ) , overall response and safety .
RESULTS	Of 106 randomised patients , 102 received study treatment ( Arm A , N = 52 ; Arm B , N = 50 ) .
RESULTS	Baseline characteristics were similar in both arms .
RESULTS	Median PFS was 2.6 months ( Arm A ) and 1.7 months ( Arm B ) ; median 6-month PFS rates were 30.7 % and 17.9 % and 12-month PFS rates were 23.7 % and 15.6 % , respectively .
RESULTS	In Arm A , 9 ( 17.3 % ) patients had partial response ( PR ) and 19 ( 36.5 % ) , stable disease ( SD ) ; PR and SD in Arm B were 2 ( 4.0 % ) and 21 ( 42.0 % ) , respectively .
RESULTS	Median OS was 8.7 months in Arm A and 11.1 months in Arm B. Patients in both arms tolerated the treatment with limited Grade 3/4 toxicities .
CONCLUSIONS	Ramucirumab alone or in combination with dacarbazine was associated with an acceptable safety profile in patients with MM .
CONCLUSIONS	Although the study was not powered for comparison between treatment arms , PFS appeared greater with combination therapy .
CONCLUSIONS	Sustained disease control was observed on both study arm .

###25117895
BACKGROUND	Many programs emphasize subsequent pregnancy prevention and high school graduation among teenage mothers ; however , less is known about their ability to increase financial earnings from employment opportunities while concurrently enrolled in school .
BACKGROUND	This study evaluates factors influencing employment status among teenage mothers after enrolling in a community-based randomized intervention .
METHODS	Project Mothers and Schools ( PMAS ) initiative participants were surveyed at baseline and 12 months after enrollment .
METHODS	The 56 control group participants received homebound education and family case management , whereas the 59 intervention group participants received these basic-level services as well as group parenting time , life skills , and leadership training .
METHODS	A generalized estimating equation was used to identify statistically significant changes associated with the intervention .
RESULTS	Participants were significantly more likely to receive money from their jobs at postintervention relative to baseline ( OR = 4.75 , p = .023 ) ; however , this change was not statistically significant when comparing the control group to the intervention group .
RESULTS	At postintervention , those who received money from parents were significantly less likely to receive money from their job ( OR = 0.12 , p = .002 ) .
CONCLUSIONS	While PMAS benefited participants in terms of employment , the role of parental support requires additional investigation to determine its influence on teenage mothers ' ability to achieve financial independence .

###24861802
OBJECTIVE	To evaluate the effect of two postnatal professional support interventions on the duration of any and exclusive breastfeeding .
METHODS	Multicentre , three-arm , cluster randomised controlled trial .
METHODS	A cohort of 722 primiparous breastfeeding mothers with uncomplicated , full-term pregnancies .
METHODS	The three study interventions were : ( 1 ) standard postnatal maternity care ; ( 2 ) standard care plus three in-hospital professional breastfeeding support sessions , of 30-45minutes in duration ; or ( 2 ) standard care plus weekly post-discharge breastfeeding telephone support , of 20-30minutes in duration , for 4weeks .
METHODS	The interventions were delivered by four trained research nurses , who were either highly experienced registered midwives or certified lactation consultants .
METHODS	Prevalence of any and exclusive breastfeeding at 1 , 2 , and 3months postpartum .
RESULTS	Rates of any and exclusive breastfeeding were higher among participants in the two intervention groups at all follow-up points , when compared with those who received standard care .
RESULTS	Participants receiving telephone support were significantly more likely to continue any breastfeeding at 1month ( 76.2 versus 67.3 % ; odds ratio , OR1 .63 , 95 % confidence interval , 95 % CI 1.10-2 .41 ) and at 2months ( 58.6 versus 48.9 % ; OR1 .48 , 95 % CI 1.04-2 .10 ) , and to be exclusively breastfeeding at 1month ( 28.4 versus 16.9 % ; OR1 .89 , 95 % CI 1.24-2 .90 ) .
RESULTS	Participants in the in-hospital support group were also more likely to be breastfeeding at all time points , but the effect was not statistically significant .
CONCLUSIONS	Professional breastfeeding telephone support provided early in the postnatal period , and continued for the first month postpartum , improves breastfeeding duration among first-time mothers .
CONCLUSIONS	It is also possible that it was the continuing nature of the support that increased the effectiveness of the intervention , rather than the delivery of the support by telephone specifically .

###24975110
BACKGROUND	Alcohol misuse among youth is a major public health concern and numbers of adolescents admitted to the emergency department for acute alcoholic intoxication in Germany are recently growing .
BACKGROUND	The emergency setting offers an opportunity to reach at-risk alcohol consuming adolescents and provide brief interventions in a potential `` teachable moment '' .
BACKGROUND	However , studies on brief interventions targeting adolescents in emergency care are scarce and little is known about their effectiveness when delivered immediately following hospitalization for acute alcohol intoxication .
BACKGROUND	In this protocol we present the HaLT-Hamburg trial evaluating a brief motivational intervention for adolescents treated in the emergency department after an episode of acute alcoholic intoxication .
METHODS	The trial design is a parallel two-arm cluster randomized-controlled trial with follow-up assessment after 3 and 6 months .
METHODS	N = 312 participants aged 17 years and younger will be recruited Fridays to Sundays in 6 pediatric clinics over a period of 30 months .
METHODS	Intervention condition is a manual-based brief motivational intervention with a telephone booster after 6 weeks and a manual-guided intervention for caregivers which will be compared to treatment as usual .
METHODS	Primary outcomes are reduction in binge drinking episodes , quantity of alcohol use on a typical drinking day and alcohol-related problems .
METHODS	Secondary outcome is further treatment seeking .
METHODS	Linear mixed models adjusted for baseline differences will be conducted according to intention-to-treat ( ITT ) and completers ( per-protocol ) principles to examine intervention effects .
METHODS	We also examine quantitative and qualitative process data on feasibility , intervention delivery , implementation and receipt from intervention providers , receivers and regular emergency department staff .
CONCLUSIONS	The study has a number of strengths .
CONCLUSIONS	First , a rigorous evaluation of HaLT-Hamburg is timely because variations of the HaLT project are widely used in Germany .
CONCLUSIONS	Second , prior research has not targeted adolescents in the presumed teachable moment following acute alcohol intoxication .
CONCLUSIONS	Third , we included a comprehensive process evaluation to raise external validity .
CONCLUSIONS	Fourth , the study involved important stakeholders from the start to set up organizational structures for implementation and maintaining project impact .
BACKGROUND	Current Controlled Trials ISRCTN31234060 ( April 30th 2012 ) .

###24832638
OBJECTIVE	Paclitaxel drug-eluting balloons ( pDEB ) could be an attractive option to minimise side branch ( SB ) restenosis in bifurcated coronary lesions .
OBJECTIVE	We compared angiographic and clinical outcomes with pDEB plus bare metal stent ( BMS ) versus drug-eluting stents ( DES ) in de novo bifurcated lesions .
RESULTS	This multicentre randomised trial included 108 patients .
RESULTS	Sequential main branch ( MB ) / SB dilatation with pDEB , with provisional T-stenting with BMS in the MB was performed in the pDEB group , and with everolimus DES in the DES group .
RESULTS	The primary endpoint was late lumen loss ( LLL ) at nine months .
RESULTS	The secondary endpoint was the incidence of major adverse cardiac events ( MACE : death , myocardial infarction , or target lesion revascularisation ) .
RESULTS	In-segment MB LLL was 0.310.48 mm in the pDEB group , and 0.160.38 mm in the DES group ( p = 0.15 ) ; mean difference was 0.15 mm ( upper limit one-sided 95 % CI : 0.27 mm ; p = 0.001 ; non-inferiority test ) .
RESULTS	LLL in SB was -0.040.76 mm in the pDEB group and -0.030.51 mm in the DES group ( p = 0.983 ) .
RESULTS	MACE and TLR were higher in the pDEB group ( 17.3 % vs. 7.1 % ; p = 0.105 , and 15.4 % vs. 3.6 % ; p = 0.045 ) , due to higher MB restenosis ( 13.5 % vs. 1.8 % ; p = 0.027 ) .
CONCLUSIONS	pDEB bifurcation pretreatment with BMS implantation in MB showed greater LLL ( ns ) and increased incidence of MACE compared to everolimus DES .
CONCLUSIONS	Both strategies showed similar results in the SB .

###25361563
BACKGROUND	Women who deliver preterm infants are at a much greater risk for repeating a preterm birth ( PTB ) , compared to women without a history of PTB .
BACKGROUND	However , little is known about the prevalence of the risk factors which account for this markedly increased risk .
BACKGROUND	Moreover , little or nothing is known about the feasibility of providing treatments and services to these women , outside of the context of prenatal care , during the inter-conception period , which provides the best opportunity for successful risk-reduction interventions .
METHODS	The Philadelphia Collaborative Preterm Prevention Project ( PCPPP ) , a large randomized control trial designed to identify and reduce six major risk factors for a repeat preterm birth among women immediately following the delivering of a preterm infant .
METHODS	For the women assigned to the PCPPP treatment group , we calculated the prevalence of the six risk factors in question , the percentages of women who agreed to receive high quality risk-appropriate treatments or services , and the of rates of participation among those who were offered and eligible for these treatments or services .
RESULTS	Urogenital tract infections were identified in 57 % of the women , while 59 % were found to have periodontal disease .
RESULTS	More than 39 % were active smokers , and 17 % were assessed with clinical depression .
RESULTS	Low literacy , and housing instability were identified in , 22 and 83 % of the study sample , respectively .
RESULTS	Among women eligible for intervention , the percentages who accepted and at least minimally participated in treatment ranged from a low of 28 % for smoking , to a high of 85 % for urogenital tract infection .
RESULTS	Most PCPPP enrollees ( 57 % ) had three or more major risk factors .
RESULTS	Participation rates associated with the PCPPP treatments or services varied markedly , and were quite low in some cases , despite considerable efforts to reduce the barriers to receiving care .
CONCLUSIONS	The efficacy of individual level risk-reduction efforts designed to prevent preterm/repeat preterm in the pre - or inter-conception period may be limited if participation rates associated with interventions to reduce major risk factors for PTB are low .
CONCLUSIONS	Achieving adequate participation may require identifying , better understanding , and eliminating barriers to access , beyond those associated with cost , transportation , childcare , and service location or hours of operation .
BACKGROUND	ClinicalTrials.gov ( NCT01117922 ) .

###25394366
OBJECTIVE	Myoelectric prostheses use electromyographic ( EMG ) signals to control movement of prosthetic joints .
OBJECTIVE	Clinically available myoelectric control strategies do not allow simultaneous movement of multiple degrees of freedom ( DOFs ) ; however , the use of implantable devices that record intramuscular EMG signals could overcome this constraint .
OBJECTIVE	The objective of this study was to evaluate the real-time simultaneous control of three DOFs ( wrist rotation , wrist flexion/extension , and hand open/close ) using intramuscular EMG .
METHODS	We evaluated task performance of five able-bodied subjects in a virtual environment using two control strategies with fine-wire EMG : ( i ) parallel dual-site differential control , which enabled simultaneous control of three DOFs and ( ii ) pattern recognition control , which required sequential control of DOFs .
RESULTS	Over the course of the experiment , subjects using parallel dual-site control demonstrated increased use of simultaneous control and improved performance in a Fitts ' Law test .
RESULTS	By the end of the experiment , performance using parallel dual-site control was significantly better ( up to a 25 % increase in throughput ) than when using sequential pattern recognition control for tasks requiring multiple DOFs .
RESULTS	The learning trends with parallel dual-site control suggested that further improvements in performance metrics were possible .
RESULTS	Subjects occasionally experienced difficulty in performing isolated single-DOF movements with parallel dual-site control but were able to accomplish related Fitts ' Law tasks with high levels of path efficiency .
CONCLUSIONS	These results suggest that intramuscular EMG , used in a parallel dual-site configuration , can provide simultaneous control of a multi-DOF prosthetic wrist and hand and may outperform current methods that enforce sequential control .

###25746399
OBJECTIVE	To simultaneously examine the effects of acute exercise intensity and free-living physical activity and sedentary behavior on cognitive function in young , healthy adults .
METHODS	Using a counterbalanced , crossover , randomized controlled design , 87 young adults ( mean age , 21.4 years ) completed various cognitive assessments with and without an acute bout of exercise preceding the assessment .
METHODS	Participants were randomized into 1 of 4 groups to complete a 30-minute bout of acute exercise : control ( no exercise ) , light intensity ( 40 % -50 % of predicted maximum heart rate [ HR ( max ) ] ) , moderate intensity ( 51 % -70 % of predicted HR ( max ) ) , or vigorous intensity ( 71 % -85 % of predicted HR ( max ) ) .
METHODS	Subjectively and objectively determined ( accelerometry ) physical activity and sedentary behavior were assessed to examine the association between these free-living behaviors and cognitive function .
METHODS	The study duration was August 26 , 2013 , to September 11 , 2014 .
RESULTS	Concentration-related cognition ( mean SD Feature Match test score ) was significantly higher after a 30-minute acute bout of moderate-intensity exercise ( 145.126.9 ) compared with cognitive assessment without exercise ( 121.319.2 ; P = .004 ) .
RESULTS	Furthermore , questionnaire-determined sedentary behavior was inversely associated with visual attention and task switching ( Trail Making Test A score ) ( = -0.23 ; P = .04 ) .
RESULTS	Last , estimated cardiorespiratory fitness ( volume of maximum oxygen consumption ) was positively associated with reasoning-related cognitive function ( Odd One Out test score ) ( = 0.49 ; P = .05 ) ; when adding metabolic equivalent of task minutes per week to this model , the results were not significant ( = 0.47 ; P = .07 ) .
CONCLUSIONS	These findings provide some support for acute moderate-intensity exercise , sedentary behavior , and cardiorespiratory fitness being associated with executive functioning-related cognitive function in young , healthy adults .

###24840045
OBJECTIVE	The purpose of this study was to assess the efficacy and safety of edivoxetine ( LY2216684 ) , a selective norepinephrine reuptake inhibitor , in pediatric patients with attention-deficit/hyperactivity disorder ( ADHD ) .
METHODS	A fixed-dose , randomized , double-blind , 8 week study was conducted in patients 6-17 years of age , who were randomized by two strata : 1 ) Patients with prior stimulant use randomized to placebo , edivoxetine 0.1 mg/kg/day , 0.2 mg/kg/day , or 0.3 mg/kg/day arms in a 1:1:1:1 ratio ; 2 ) Stimulant-nave patients randomized to placebo , edivoxetine 0.1 mg/kg/day , 0.2 mg/kg/day , 0.3 mg/kg/day , or osmotic-release oral system methylphenidate ( OROS MPH ) ( 18-54mg / day based on body weight ) arms in a 1:1:1:1:1 ratio .
METHODS	The primary efficacy measure was baseline-to-week 8 change of ADHD Rating Scale ( ADHD-RS ) total score for edivoxetine 0.2 mg/kg/day and 0.3 mg/kg/day .
RESULTS	A total of 340 patients were randomized to placebo ( n = 78 ) ; edivoxetine 0.1 mg/kg/day ( n = 76 ) , 0.2 mg/kg/day ( n = 75 ) , or 0.3 mg/kg/day ( n = 75 ) ; or OROS MPH ( n = 36 ) .
RESULTS	In the stimulant-nave stratum , the positive control , OROS MPH , was significantly superior to placebo in mean ADHD-RS total score change at end-point ( -19.46 , p = 0.015 ) .
RESULTS	The edivoxetine 0.2 mg/kg/day and 0.3 mg/kg/day arms had statistically significantly greater improvement than the placebo arm in mean ADHD-RS total score change at end-point ( placebo -10.35 ; edivoxetine 0.2 mg/kg/day -16.09 , p < 0.010 ; edivoxetine 0.3 mg/kg/day -16.39 , p < 0.010 ) and Clinical Global Impressions-Improvement score ( placebo 3.05 ; edivoxetine 0.1 mg/kg/day 3.01 , p = 0.860 ; edivoxetine 0.2 mg/kg/day 2.54 , p = 0.013 ; edivoxetine 0.3 mg/kg/day 2.53 , p = 0.013 ) .
RESULTS	In the overall efficacy-analyses data set ( n = 270 ) , the effect size estimates for edivoxetine doses 0.1 mg/kg/day , 0.2 mg/kg/day and 0.3 mg/kg/day at the week 8 time point were 0.17 , 0.51 , and 0.54 , respectively ( for the stimulant-nave stratum , the effect size estimate for OROS MPH was 0.69 ) .
RESULTS	Compared with placebo , edivoxetine treatment was associated with statistically significant increases in blood pressure and pulse ( p < 0.050 ) , and a smaller increase or slight decrease in weight .
CONCLUSIONS	Edivoxetine at doses of 0.2 mg/kg/day and 0.3 mg/kg/day demonstrated efficacy in ADHD treatment , despite the presence of a sizeable placebo response .
CONCLUSIONS	No unexpected adverse events were identified .
CONCLUSIONS	Clinical Trial Registry identifier : NCT00922636 .

###24931061
OBJECTIVE	To evaluate the relationship between number of metabolic syndrome ( MetS ) - like components and prostate cancer diagnosis in a group of men where nearly all biopsies were taken independent of prostate-specific antigen ( PSA ) level , thus minimising any confounding from how the various MetS-like components may influence PSA levels .
METHODS	We analysed data from 6426 men in the Reduction by Dutasteride of Prostate Cancer Events ( REDUCE ) study with at least one on-study biopsy .
METHODS	REDUCE compared dutasteride vs placebo on prostate cancer risk among men with an elevated PSA level and negative pre-study biopsy and included two on-study biopsies regardless of PSA level at 2 and 4 years .
METHODS	Available data for MetS-like components included data on diabetes , hypertension , hypercholesterolaemia , and body mass index .
METHODS	The association between number of these MetS-like components and prostate cancer risk and low-grade ( Gleason sum < 7 ) or high-grade ( Gleason sum > 7 ) vs no prostate cancer was evaluated using logistic regression .
RESULTS	In all , 2171 men ( 34 % ) had one MetS-like component , 724 ( 11 % ) had two , and 163 ( 3 % ) had three or four .
RESULTS	Men with more MetS-like components had lower PSA levels ( P = 0.029 ) .
RESULTS	One vs no MetS-like components was protective for overall prostate cancer ( P = 0.041 ) and low-grade prostate cancer ( P = 0.010 ) .
RESULTS	Two ( P = 0.69 ) or three to four ( P = 0.15 ) MetS-like components were not significantly related to prostate cancer .
RESULTS	While one MetS-like component was unrelated to high-grade prostate cancer ( P = 0.97 ) , two ( P = 0.059 ) or three to four MetS-like components ( P = 0.02 ) were associated with increased high-grade prostate cancer risk , although only the latter was significant .
CONCLUSIONS	When biopsies are largely PSA level independent , men with an initial elevated PSA level and a previous negative biopsy , and multiple MetS-like components were at an increased risk of high-grade prostate cancer , suggesting the link between MetS-like components and high-grade prostate cancer is unrelated to a lowered PSA level .

###25338995
BACKGROUND	Qigong is highly favoured among Asian breast cancer survivors for enhancing health .
BACKGROUND	This study examined the hypothesis that quality of life ( QoL ) in the Qigong group is better than the placebo ( aerobic ) or usual care group .
METHODS	A total of 197 participants were randomly assigned to either the 8-week Kuala Lumpur Qigong Trial or control groups in 2010-2011 .
METHODS	Measurement taken at baseline and post - intervention included QoL , distress and fatigue .
METHODS	Analysis of covariance ( ANCOVA ) and Kruskal Wallis were used to examine for differences between groups in the measurements .
RESULTS	There were 95 consenting participants in this 8week trial .
RESULTS	The adherence rates were 63 % for Qigong and 65 % for the placebo group .
RESULTS	The Qigong group showed significant marginal improvement in Quality of life scores compared to placebo ( mean difference = 7.3 unit ; p = 0.036 ) , compared to usual care ( mean difference = 6.7 unit ; p = 0.048 ) on Functional Assessment Cancer Therapy-Breast measure .
RESULTS	There were no significant changes between the placebo and usual care groups in fatigue or distress at post intervention ( 8-week ) .
CONCLUSIONS	Cancer survivors who participated in the Qigong intervention showed slightly better QOL .
CONCLUSIONS	Follow up studies are greatly needed to evaluate which subgroups may best benefit from Qigong .
CONCLUSIONS	With a steep rise of cancer survivors , there is an urgent need to explore and engage more cultural means of physical activity to fight side effects of treatment and for cancer control in developing countries .

###24311451
OBJECTIVE	Our goal was to evaluate the effect of breakfast size and composition on body weight , glycemic control , and metabolic markers in adults with type 2 diabetes mellitus ( T2DM ) .
METHODS	59 overweight/obese adults with T2DM were randomized to one of two isocaloric diabetic diets for 3 months ; big breakfast ( BB ) , breakfast was rich in fat and protein and provided 33 % of total daily energy or small breakfast ( SB ) , breakfast was rich in carbohydrates and provided 12.5 % of total daily energy .
RESULTS	Although body weight was reduced similarly in both groups , the BB group showed greater HbA1c and systolic blood pressure reductions ( HbA1c : -4.62 % vs. -1.46 % , p = 0.047 ; SBP -9.58 vs. -2.43 mmHg ; p = 0.04 ) .
RESULTS	T2DM medication dose was reduced in a greater proportion of the BB participants ( 31 % vs. 0 % ; p = 0.002 ) while in the SB , a greater proportion of participants had a dose increases ( 16.7 % vs. 3.4 % ; p = 0.002 ) .
RESULTS	Hunger scores were lower in the BB group and greater improvements in fasting glucose were observed in the BB group .
CONCLUSIONS	A simple dietary manipulation enriching breakfast with energy as protein and fat appears to confer metabolic benefits and might be a useful alternative for the management of T2DM .

###24314824
OBJECTIVE	To evaluate the association between baseline comprehensive geriatric assessment ( CGA ) or the Groningen Frailty Indicator ( GFI ) and toxicity in elderly metastatic breast cancer ( MBC ) patients treated with first-line palliative chemotherapy .
METHODS	MBC patients ( 65 years ) were randomized between pegylated liposomal doxorubicine or capecitabine .
METHODS	CGA included instrumental activities of daily living ( IADL ) , cognition using the mini-mental state examination ( MMSE ) , mood using the geriatric depression scale ( GDS ) , comorbidity using the Charlson index , polypharmacy and nutritional status using the body mass index .
METHODS	Frailty on CGA was defined as one or more of the following : IADL13 , MMSE23 , GDS5 , BMI20 , 5 medications or Charlson 2 .
METHODS	The cut-off for frailty on the GFI was 4 .
RESULTS	Of the randomized 78 patients ( median age 75.5 years , range 65.8-86 .8 years ) , 73 were evaluable for CGA ; 52 ( 71 % ) had one or more geriatric conditions .
RESULTS	Grade 3-4 chemotherapy-related toxicity was experienced by 19 % of patients without geriatric conditions compared to 56 % of patients with two geriatric conditions and 80 % of those with three or more ( p = 0.002 ) .
RESULTS	Polypharmacy was the only individual factor significantly associated with toxicity ( p = 0.001 ) .
RESULTS	GFI had a sensitivity of 69 % and a specificity of 76 % for frailty on CGA , and was not significantly associated with survival or toxicity .
CONCLUSIONS	In this study of elderly patients with MBC , the number of geriatric conditions correlated with grade 3-4 chemotherapy-related toxicity .
CONCLUSIONS	Therefore , in elderly patients for whom chemotherapy is being considered , a CGA could be a useful addition to the decision-making process .

###24333062
BACKGROUND	Hereditary haemochromatosis may result in severe organ damage which can be prevented by therapy .
BACKGROUND	We studied the possible advantages and disadvantages of erythrocytapheresis as compared with phlebotomy in patients with hereditary haemochromatosis .
METHODS	In a prospective , randomised , open-label study , patients with hereditary haemochromatosis were randomised to bi-weekly apheresis or weekly whole blood phlebotomy .
METHODS	Primary end-points were decrease in ferritin levels and transferrin saturation .
METHODS	Secondary endpoints were decrease in haemoglobin levels , discomfort during the therapeutic procedure , costs and technicians ' working time .
RESULTS	Sixty-two patients were included .
RESULTS	Thirty patients were randomised to apheresis and 32 to whole blood phlebotomy .
RESULTS	Initially , ferritin levels declined more rapidly in the apheresis group , and the difference became statistically highly significant at 11 weeks ; however , time to normalisation of ferritin level was equal in the two groups .
RESULTS	We observed no significant differences in decline of transferrin saturation , haemoglobin levels or discomfort .
RESULTS	The mean cumulative technician time consumption until the ferritin level reached 50 g/L was longer in the apheresis group , but the difference was not statistically significant .
RESULTS	The cumulative costs for materials until achievement of the desired ferritin levels were three-fold higher in the apheresis group .
CONCLUSIONS	Treatment of hereditary haemochromatosis with erythrocytapheresis instead of whole blood phlebotomy results in a more rapid initial decline in ferritin levels and a reduced number of procedures per patient , but not in earlier achievement of target ferritin level .
CONCLUSIONS	The frequency of discomfort was equally low with the two methods .
CONCLUSIONS	The costs and , probably , technician time consumption were higher in the apheresis group .

###24285251
BACKGROUND	SMOFlipid 20 % is intravenous lipid emulsion ( ILE ) containing long-chain triglycerides ( LCT ) , medium-chain triglycerides ( MCT ) , olive oil , and fish oil as a mixed emulsion containing - tocopherol .
BACKGROUND	The aim was to assess the efficacy of this new ILE in gastrointestinal surgery compared with MCT/LCT .
METHODS	In this prospective study , 40 patients were randomized to SMOFlipid 20 % or MCT/LCT ( Lipovenoes 20 % ) group .
METHODS	Clinical and biochemistry data were collected .
METHODS	Inflammatory markers ( CRP , IL-6 , IL-10 , TNF - , TGF-1 ) and oxidative stress ( ROS and superoxide ) were measured .
RESULTS	Thirty-five patients ( 17 males and 18 females ) with a mean age of 57 years completed the study .
RESULTS	The patients ' demographic characteristics ( age , gender , height , body weight , and BMI ) were similar without significant differences between groups .
RESULTS	The increment of triglyceride on day 6 from baseline was significantly lower in SMOFlipid group than in Lipovenoes MCT/LCT group .
RESULTS	Inflammatory markers , as well as superoxide radical and total oxygen radical were not different between groups .
CONCLUSIONS	Despite the comparable effect on inflammatory response , because of its well-balanced fatty acid pattern , relatively low n-6 : n-3 ratio , and high vitamin E content , SMOFlipid had a better triglyceride-lowering effect as compared with MCT/LCT in adult patients undergoing gastrointestinal surgery .

###24617227
OBJECTIVE	To explore therapeutic effect and action mechanism of regulating spleen-stomach needling on diabetic nephropathy ( DN ) .
METHODS	Using multi-centric , randomized , controlled and blind principles , 144 cases of DN were divided into an observation group and a control group according to random digital tab , 72 cases in each one .
METHODS	Based on regular treatment of diabetes , the regulating spleen-stomach needling was applied at Zhongwan ( CV 12 ) , Quchi ( LI 11 ) , Hegu ( LI 4 ) and Xuehai ( SP 10 ) , etc. in the observation group while Shenshu ( BL 23 ) , Taixi ( KI 3 ) , Sanyinjiao ( SP 6 ) , Yanglingquan ( GB 34 ) , etc. were selected in the control group by reference of Acupuncture and moxibustion .
METHODS	The treatment was given twice a day , six days as a treatment session with interval of one day between sessions .
METHODS	Totally six weeks were required .
METHODS	Changes of clinical symptoms and signs , fast blood glucose ( FBG ) , urinary albumin excretion rate ( UAER ) , beta2-microglobulin ( beta2-MG ) , monocyte chemotactic protein-1 ( MCP-1 ) , lymphocyte membrane cholesterol , propanediol ( MDA ) , PCO , 8-hydroxydeoxy guanosine ( 8-OHdG ) , superoxide dismutase ( SOD ) , CD3 + , CD4 + , CD8 + , and CD4 + / CD8 + were observed before and after treatment in two groups .
RESULTS	As for improving clinical symptoms and signs , total effective rate was 84.29 % ( 59/70 ) in the observation group and 55.56 % ( 40/72 ) in the control group , which had statistical difference between two groups ( P < 0.01 ) .
RESULTS	As for regulating glycometabolism [ ( 6.25 + / - 0.32 ) mmol/L vs ( 8.09 + / - 0.63 ) mmol/L ] , reducing UAER [ ( 154.43 + / - 55.14 ) mg/24h vs ( 268.91 + / - 77.65 ) mg/24h ] , restraining over-expression of MCP-1 [ ( 137.59 + / - 36.15 ) pg/mL vs ( 166.89 + / - 42.82 ) pg/mL ] , regulating level of oxidative stress , prohibiting oxidation of protein and adjusting quantity and activity of T lymphocyte subgroup , the observation group was superior to the control group ( P < 0.05 , P < 0.01 ) .
CONCLUSIONS	The regulating spleen-stomach needling is an effective method for treatment of DN , which cold improve glycometabolism disturbance-induced progressive kidney injury , recover glomerular filtration , reduce urinary albumin excretion rate , restrain overexpression of MCP-1 , adjust level of oxidative stress , prohibit oxidation of protein , increase protectiveness of membrane , adjust quantity and activity abnormity of T lymphocyte subgroup , leading to repairing lymphocyte damage and improving immune expression to delay kidney damage .

###24624911
OBJECTIVE	We investigated candidate genes associated with thiopurine metabolism and clinical response in childhood acute lymphoblastic leukemia .
METHODS	We performed genome-wide SNP association studies of 6-thioguanine and 6-mercaptopurine cytotoxicity using lymphoblastoid cell lines .
METHODS	We then genotyped the top SNPs associated with lymphoblastoid cell line cytotoxicity , together with tagSNPs for genes in the ` thiopurine pathway ' ( 686 total SNPs ) , in DNA from 589 Caucasian UK ALL97 patients .
METHODS	Functional validation studies were performed by siRNA knockdown in cancer cell lines .
RESULTS	SNPs in the thiopurine pathway genes ABCC4 , ABCC5 , IMPDH1 , ITPA , SLC28A3 and XDH , and SNPs located within or near ATP6AP2 , FRMD4B , GNG2 , KCNMA1 and NME1 , were associated with clinical response and measures of thiopurine metabolism .
RESULTS	Functional validation showed shifts in cytotoxicity for these genes .
CONCLUSIONS	The clinical response to thiopurines may be regulated by variation in known thiopurine pathway genes and additional novel genes outside of the thiopurine pathway .

###24598046
BACKGROUND	We performed a prospective , randomized , placebo-controlled study aimed to evaluate the efficacy and safety of a sedation protocol based on intranasal Ketamine and Midazolam ( INKM ) administered by a mucosal atomizer device in uncooperative children undergoing gastric aspirates for suspected tuberculosis .
METHODS	evaluation of Modified Objective Pain Score ( MOPS ) reduction in children undergoing INKM compared to the placebo group .
RESULTS	evaluation of safety of INKM protocol , start time sedation effect , duration of sedation and evaluation of parents and doctors ' satisfaction about the procedure .
METHODS	In the sedation group , 19 children , mean age 41.5 months , received intranasal Midazolam ( 0.5 mg/kg ) and Ketamine ( 2 mg/kg ) .
METHODS	In the placebo group , 17 children received normal saline solution twice in each nostril .
METHODS	The child 's degree of sedation was scored using the MOPS .
METHODS	A questionnaire was designed to evaluate the parents ' and doctors ' opinions on the procedures of both groups .
RESULTS	Fifty-seven gastric washings were performed in the sedation-group , while in the placebo-group we performed 51 gastric aspirates .
RESULTS	The degree of sedation achieved by INMK enabled all procedures to be completed without additional drugs .
RESULTS	The mean duration of sedation was 71.5 min .
RESULTS	Mean MOPS was 3.5 ( range 1-8 ) in the sedation-group , 7.2 ( range 4-9 ) in the placebo-group ( p < 0.0001 ) .
RESULTS	The questionnaire revealed high levels of satisfaction by both doctors and parents in the sedation-group compared to the placebo-group .
RESULTS	The only side effect registered was post-sedation agitation in 6 procedures in the sedation group ( 10.5 % ) .
CONCLUSIONS	Our experience suggests that atomized INKM makes gastric aspirates more acceptable and easy to perform in children .
BACKGROUND	Unique trial Number : UMIN000010623 ; Receipt Number : R000012422 .

###24274882
OBJECTIVE	To determine the optimal method for use of the Canine Brief Pain Inventory ( CBPI ) to quantitate responses of dogs with osteoarthritis to treatment with carprofen or placebo .
METHODS	150 dogs with osteoarthritis .
METHODS	Data were analyzed from 2 studies with identical protocols in which owner-completed CBPIs were used .
METHODS	Treatment for each dog was classified as a success or failure by comparing the pain severity score ( PSS ) and pain interference score ( PIS ) on day 0 ( baseline ) with those on day 14 .
METHODS	Treatment success or failure was defined on the basis of various combinations of reduction in the 2 scores when inclusion criteria were set as a PSS and PIS 1 , 2 , or 3 at baseline .
METHODS	Statistical analyses were performed to select the definition of treatment success that had the greatest statistical power to detect differences between carprofen and placebo treatments .
RESULTS	Defining treatment success as a reduction of 1 in PSS and 2 in PIS in each dog had consistently robust power .
RESULTS	Power was 62.8 % in the population that included only dogs with baseline scores 2 and 64.7 % in the population that included only dogs with baseline scores 3 .
CONCLUSIONS	The CBPI had robust statistical power to evaluate the treatment effect of carprofen in dogs with osteoarthritis when protocol success criteria were predefined as a reduction 1 in PIS and 2 in PSS .
CONCLUSIONS	Results indicated the CBPI can be used as an outcome measure in clinical trials to evaluate new pain treatments when it is desirable to evaluate success in individual dogs rather than overall mean or median scores in a test population .

###24438744
BACKGROUND	Two once-daily long-acting muscarinic antagonists ( LAMAs ) are currently available for the treatment of chronic obstructive pulmonary disease ( COPD ) - tiotropium and glycopyrronium .
BACKGROUND	Previous studies have compared glycopyrronium with open-label tiotropium .
BACKGROUND	In the GLOW5 study , we compare glycopyrronium with blinded tiotropium .
METHODS	In this blinded , double-dummy , parallel group , 12-week study , patients with moderate-to-severe COPD were randomized 1:1 to glycopyrronium 50 g once daily or tiotropium 18 g once daily .
METHODS	The primary objective was to demonstrate the non-inferiority of glycopyrronium versus blinded tiotropium with respect to trough forced expiratory volume in 1 second ( FEV1 ) following 12 weeks of treatment ( non-inferiority margin : -50 mL ) .
METHODS	Secondary objectives were to evaluate glycopyrronium versus tiotropium for other spirometric outcomes , breathlessness ( Transition Dyspnea Index ; TDI ) , health status ( St George 's Respiratory Questionnaire ; SGRQ ) , daily rescue medication use , COPD exacerbations and COPD symptoms over 12 weeks of treatment .
RESULTS	657 patients were randomized ( glycopyrronium : 327 ; tiotropium : 330 ) ; 96 % ( 630 patients ) completed the study .
RESULTS	Least squares mean trough FEV1 for both glycopyrronium and tiotropium was 1.405 L at Week 12 , meeting the criterion for non-inferiority ( mean treatment difference : 0 mL , 95 % CI : -32 , 31 mL ) .
RESULTS	Glycopyrronium demonstrated rapid bronchodilation following first dose on Day 1 , with significantly higher FEV1 at all time points from 0-4 h post-dose versus tiotropium ( all p < 0.001 ) .
RESULTS	FEV1 area under the curve from 0-4 h ( AUC0-4h ) post-dose with glycopyrronium was significantly superior to tiotropium on Day 1 ( p < 0.001 ) and was comparable to tiotropium at Week 12 .
RESULTS	Glycopyrronium demonstrated comparable improvements to tiotropium in TDI focal score , SGRQ total score , rescue medication use and the rate of COPD exacerbations ( all p = not significant ) .
RESULTS	Patients on glycopyrronium also had a significantly lower total COPD symptom score versus patients on tiotropium after 12 weeks ( p = 0.035 ) .
RESULTS	Adverse events were reported by a similar percentage of patients receiving glycopyrronium ( 40.4 % ) and tiotropium ( 40.6 % ) .
CONCLUSIONS	In patients with moderate-to-severe COPD , 12-week blinded treatment with once-daily glycopyrronium 50 g or tiotropium 18 g , provided similar efficacy and safety , with glycopyrronium having a faster onset of action on Day 1 versus tiotropium .

###25749297
OBJECTIVE	To investigate the potential of lipoprotein-associated phospholipase A2 inhibition as a novel mechanism to reduce edema and improve vision in center-involved diabetic macular edema ( DME ) .
METHODS	Prospective , multicenter , randomized , double-masked , placebo-controlled phase IIa study .
METHODS	Fifty-four center-involved DME patients randomized 2:1 to receive darapladib ( n = 36 ) or placebo ( n = 18 ) .
METHODS	Darapladib 160 mg or placebo monotherapy was administered orally once daily for 3 months , and patients were followed up monthly for 4 months .
METHODS	Mean change from baseline in best-corrected visual acuity ( BCVA ) and the center subfield and center point of the study eye at month 3 as determined by spectral-domain optical coherence tomography .
RESULTS	Five patients in the study received intravitreal anti-vascular endothelial growth factor rescue therapy before the day 90 assessment , 2 of 36 ( 6 % ) in the darapladib arm and 3 of 18 ( 17 % ) in the placebo arm .
RESULTS	Administration of 160 mg darapladib for 3 months resulted in statistically significant mean improvements , from baseline to month 3 , in BCVA of 4.1 Early Treatment Diabetic Retinopathy Study ( ETDRS ) letters ( 95 % confidence interval [ CI ] , 2.3-5 .8 ) and of 57 m in central subfield thickness ( 95 % CI , -84 to -30 ) in the study eyes .
RESULTS	An increase in BCVA of 1.7 ETDRS letters ( 95 % CI , -1.0 to 4.4 ) and a decrease in center subfield thickness of 34 m ( 95 % CI , -75 to 6.8 ) for the placebo group were not significant .
RESULTS	No ocular severe adverse events ( SAEs ) or SAEs considered related to darapladib were reported .
RESULTS	One SAE of myocardial infarction , not considered related to darapladib , was reported , and 1 SAE of severe diarrhea was reported in a placebo patient , subsequently withdrawn from the study .
RESULTS	Study eye ocular adverse events ( AEs ) and nonocular AEs were similar between treatment groups .
CONCLUSIONS	Once-daily oral darapladib administered for 3 months demonstrated modest improvements in vision and macular edema that warrant additional investigation of this novel lipoprotein-associated phospholipase A2 inhibitory mechanism for the treatment of DME .

###25015353
OBJECTIVE	To characterize retinal metabolism during normoxia and hyperoxia in healthy subjects .
METHODS	Forty-six healthy subjects were included in the present study , and data of 41 subjects could be evaluated .
METHODS	Retinal vessel diameters , as well as oxygen saturation in arteries and veins , were measured using the Dynamic Vessel Analyzer .
METHODS	In addition , retinal venous blood velocity was measured using bidirectional laser Doppler velocimetry , retinal blood flow was calculated , and oxygen and carbon dioxide partial pressures were measured from arterialized capillary blood from the earlobe .
METHODS	Measurements were done during normoxia and during 100 % oxygen breathing .
RESULTS	Systemic hyperoxia caused a significant decrease in retinal venous diameter ( -13.0 % 4.5 % ) and arterial diameter ( -12.1 % 4.0 % ) , in retinal blood velocity ( -43.4 % 7.7 % ) , and in retinal blood flow ( -57.0 % 5.7 % ) ( P < 0.001 for all ) .
RESULTS	Oxygen saturation increased in retinal arteries ( +4.4 % 2.3 % ) and in retinal veins ( +19.6 % 6.2 % ) , but the arteriovenous oxygen content difference significantly decreased ( -29.4 % 19.5 % ) ( P < 0.001 for all ) .
RESULTS	Blood oxygen tension in arterialized blood showed a pronounced increase from 90.2 7.7 to 371.3 92.7 mm Hg ( P < 0.001 ) .
RESULTS	Calculated oxygen extraction in the eye decreased by as much as 62.5 % 9.5 % ( P < 0.001 ) .
CONCLUSIONS	Our data are compatible with the hypothesis that during 100 % oxygen breathing a large amount of oxygen , consumed by the inner retina , comes from the choroid , which is supported by previous animal data .
CONCLUSIONS	Interpretation of oxygen saturation data in retinal arteries and veins without quantifying blood flow is difficult .
CONCLUSIONS	( ClinicalTrials.gov number , NCT01692821 . )

###24438582
BACKGROUND	Young people in sub-Saharan Africa are affected by the HIV pandemic to a greater extent than young people elsewhere and effective HIV-preventive intervention programmes are urgently needed .
BACKGROUND	The present article presents the rationale behind an EU-funded research project ( PREPARE ) examining effects of community-based ( school delivered ) interventions conducted in four sites in sub-Saharan Africa .
BACKGROUND	One intervention focuses on changing beliefs and cognitions related to sexual practices ( Mankweng , Limpopo , South Africa ) .
BACKGROUND	Another promotes improved parent-offspring communication on sexuality ( Kampala , Uganda ) .
BACKGROUND	Two further interventions are more comprehensive aiming to promote healthy sexual practices .
BACKGROUND	One of these ( Western Cape , South Africa ) also aims to reduce intimate partner violence while the other ( Dar es Salaam , Tanzania ) utilises school-based peer education .
METHODS	A modified Intervention Mapping approach is used to develop all programmes .
METHODS	Cluster randomised controlled trials of programmes delivered to school students aged 12-14 will be conducted in each study site .
METHODS	Schools will be randomly allocated ( after matching or stratification ) to intervention and delayed intervention arms .
METHODS	Baseline surveys at each site are followed by interventions and then by one ( Kampala and Limpopo ) or two ( Western Cape and Dar es Salaam ) post-intervention data collections .
METHODS	Questionnaires include questions common for all sites and are partly based on a set of social cognition models previously applied to the study of HIV-preventive behaviours .
METHODS	Data from all sites will be merged in order to compare prevalence and associations across sites on core variables .
METHODS	Power is set to .80 or higher and significance level to .05 or lower in order to detect intervention effects .
METHODS	Intraclass correlations will be estimated from previous surveys carried out at each site .
CONCLUSIONS	We expect PREPARE interventions to have an impact on hypothesized determinants of risky sexual behaviour and in Western Cape and Dar es Salaam to change sexual practices .
CONCLUSIONS	Results from PREPARE will ( i ) identify modifiable cognitions and social processes related to risky sexual behaviour and ( ii ) identify promising intervention approaches among young adolescents in sub-Saharan cultures and contexts .
BACKGROUND	Controlled Trials ISRCTN56270821 ( Cape Town ) ; Controlled Trials ISRCTN10386599 ( Limpopo ) ; Clinical Trials NCT01772628 ( Kampala ) ; Australian New Zealand Clinical Trials Registry ACTRN12613000900718 ( Dar es Salaam ) .

###24595568
BACKGROUND	Though topical corticosteroids ( TC ) are used for treating atopic dermatitis ( AD ) as a standard , there exist several problems including topical steroid addiction ( TSA ) or Red skin syndrome .
BACKGROUND	Moreover , the number of patients , who refrain from using TC because of steroid-phobia , is increasing .
BACKGROUND	Recently , topical PPAR alpha ligand application has been reported to improve experimental allergic dermatitis .
BACKGROUND	The purpose of this study was to investigate the short-term efficacy and safety of topical clofibrate , one of PPAR alpha ligand , in such steroid-phobic patients with AD .
METHODS	This study was conducted as a double-blind design to investigate the effects of random administration of topical clofibrate and base ( placebo ) on skin manifestation and blood parameters of patients for 2 weeks .
METHODS	Severity was digitized using severity scoring systems for atopic dermatitis by the Japanese Dermatological Association ( SSS-JDA ) before and after two weeks .
METHODS	Subjective severity of patients was evaluated using visual analog scale ( Pt-VAS ) .
METHODS	Serum thymus and activation-regulated chemokine ( TARC ) and immunoglobulin E ( IgE ) were also investigated .
RESULTS	Twenty patients were enrolled , and 19 of 20 patients completed the study .
RESULTS	In 19 patients , the value of severity score using SSS-JDA was decreased significantly after administration of topical clofibrate ( P = 0.001 ) .
RESULTS	Subjective evaluation using Pt-VAS ( P = 0.008 ) and serum TARC levels ( P = 0.03 ) were also significantly decreased after two weeks of topical clofibrate .
RESULTS	There was not a significant difference in serum IgE levels .
RESULTS	No adverse effect was observed .
CONCLUSIONS	Topical clofibrate is useful for patients with AD especially who are reluctant to use topical steroids .

###25317090
OBJECTIVE	To evaluate the effects of single doses of gabapentin 250 and 500 mg on polysomnographic ( PSG ) and participant-reported sleep measures in a 5-h phase advance insomnia model .
METHODS	Adults reporting occasional disturbed sleep received gabapentin 500 mg ( n = 125 ) , 250 mg ( n = 125 ) , or placebo ( n = 127 ) 30 min prior to bedtime and were in bed from 17:00 to 01:00 , 5 h before their habitual bedtime .
METHODS	Sleep was assessed by PSG , post-sleep questionnaire , and the Karolinska Sleep Diary ( KSD ) .
METHODS	Next-day residual effects ( Digit Symbol Substitution Test [ DSST ] and Stanford Sleepiness Scale [ SSS ] ) and tolerability were assessed .
RESULTS	Demographics were comparable among groups .
RESULTS	Among PSG endpoints , wake after sleep onset ( primary endpoint ) ( 135.7 [ placebo ] , 100.7 [ 250 mg ] , and 73.2 [ 500 mg ] min ) was significantly lower and total sleep time ( TST ) ( 311.4 , 356.5 , and 378.7 min ) significantly greater in both gabapentin groups versus placebo .
RESULTS	Latency to persistent sleep was not significantly different among groups .
RESULTS	Percent slow wave sleep ( 12.6 % , 15.4 % , and 17.0 % , respectively ) was significantly greater and percent stage 1 ( 15.1 % , 11.8 % , and 10.8 % , respectively ) significantly lower relative to placebo .
RESULTS	Gabapentin was associated with significantly higher values of KSD Sleep Quality Index and reported TST versus placebo ; no other reported outcomes were significant .
RESULTS	Neither gabapentin dose produced evidence of next-day residual effects as measured by DSST and SSS .
RESULTS	Adverse events were infrequent ( < 5 % ) .
CONCLUSIONS	Participants with occasional disturbed sleep treated with gabapentin showed significantly longer sleep duration and greater depth ( versus placebo ) in response to a phase advance manipulation known to disrupt sleep maintenance .

###24572581
BACKGROUND	The aim of this study is to evaluate the clinical efficacy of short-term psychodynamic psychotherapy ( STPP ) in comparison with treatment as usual ( TAU ) in treatment of patients suffering from anxiety and depressive disorders .
METHODS	Sixty patients were recruited from the Psychotherapy Service , University of Milan , Department of Psychiatry , at Milan 's IRCCS Foundation Ca ' Granda , Ospedale Maggiore Policlinico with the diagnosis of depressive or anxiety disorders according to DSM-IV-TR criteria .
METHODS	These subjects were randomly assigned in a 1:1 ratio to an intervention group ( STPP ) or control group ( TAU ) for 12 months ( T1 ) .
METHODS	Each patient was clinically evaluated at the moment of recruitment ( T0 ) and after 12 months using a battery composed of these scales : Clinical Global Impression Scale ( CGI ) , Symptom Checklist-90-Revised ( SCL-90-R ) , Inventory of Interpersonal Problems ( IIP ) .
RESULTS	Statistical analysis highlighted significant improvements ( p < 0.05 ) for the group treated with STPP in every clinical scale .
RESULTS	Instead control group revealed significant changes ( p < 0.05 ) only for SCL-90 scale scores .
RESULTS	We noticed a clinical improvement in both groups without particular differences , but the IIP scores went through a significant higher enhancement only in STPP group .
CONCLUSIONS	Our results suggest that STPP is so effective as TAU in treatment of anxiety and depressive disorders .
CONCLUSIONS	Moreover STPP leads to a better recover of relational functioning .

###24922046
BACKGROUND	Carotid artery stenting ( CAS ) is a worldwide diffuse intervention , but may be associated with distal plaque component embolization , and sometimes major and minor stroke .
BACKGROUND	Statin use has been demonstrated to reduce atherosclerotic plaque burden , but its effect in reducing distal embolization during carotid stenting has not yet been well validated .
OBJECTIVE	With the Rosuvastatin Pretreatment to Reduce Embolization during Carotid Artery Stenting trial , we aim to discover if a pretreatement with high doses of rosuvastatin in dyslipidemic patients is able to reduce periprocedural cerebral ischemic complications following carotid stenting .
METHODS	This is a phase III prospective , randomized controlled trial .
METHODS	All consecutive patients with asymptomatic carotid stenosis at least 80 % will be randomized to a 6-week rosuvastatin treatment followed by carotid stenting , and to direct carotid stenting .
METHODS	Carotid stenting will be performed following common practice with distal or proximal embolic protection .
METHODS	The primary efficacy end point of the trial will be the prevalence of ` relevant ' embolization during CAS , as a surrogate end point for cerebral ischemic complications .
METHODS	Other laboratory and clinical data will be registered and patients will be followed up to 1 year .
METHODS	In order to obtain the expected superiority of statin pretreatment on primary end point , a population of 130 patients will be enrolled into the study .
CONCLUSIONS	In conclusion , with the Rosuvastatin Pretreatment to Reduce Embolization during Carotid Artery Stenting trial , we want to evaluate whether a high dose of rosuvastatin for 6 weeks before CAS in asymptomatic patients with severe carotid stenosis is able to reduce the rate of plaque embolization during the procedure , thus suggesting a possible reduction in cerebral ischemic complications .

###24914630
BACKGROUND	Among the various factors influencing the success rate , onset time , and duration of peripheral nerve blocks , the role of local anesthetics concentration remains uncertain .
BACKGROUND	In this prospective , randomized , single-blinded study , we evaluated whether varying the dilution of a fixed dose of mepivacaine solution influenced onset time and duration of sciatic nerve block .
METHODS	Ninety ASA physical status I to II patients scheduled for foot surgery were randomly allocated to receive a double-injection Labat sciatic nerve block with 12 mL mepivacaine 2 % ( group concentration I = 45 patients ) or 24 mL of mepivacaine 1 % ( group volume II = 45 patients ) .
METHODS	The nerve stimulator was initially set at 2 Hz , 0.1 millisecond , 1 mA .
METHODS	The total amount of local anesthetic ( 240 mg ) was kept constant and equally divided between the peroneal and tibial nerves .
METHODS	All patients also received an ultrasound-guided popliteal sciatic nerve catheter for postoperative analgesia .
METHODS	Times to readiness for surgery , performance , and offset of local anesthetic were recorded .
METHODS	Our primary end point was to determine a possible difference in offset time between groups .
METHODS	Continuous variables were expressed as median ( IQR ) and compared with the Wilcoxon-Mann-Whitney U test ; WMWodds are reported together with their 95 % confidence interval .
RESULTS	The overall success rate of sciatic nerve block was 99 % .
RESULTS	Time of performance was shorter in group I , 120 seconds ( 90-150 seconds ) , than that in group II , 150 seconds ( 120-180 seconds ) ( P = 0.0048 ; WMWodds 2.26 [ 1.35-4 .34 ] ) .
RESULTS	The onset time of sensory and motor sciatic nerve block was 4 minutes ( 2-9 minutes ) in group I and 6 minutes ( 4-10 minutes ) in group II ( P = 0.41 ; WMWodds 1.21 [ 0.77-1 .95 ] ) , while the duration of sensory block was 235 minutes ( 203-250 minutes ) in group I , and 240 minutes ( 218-247 minutes ) in group II respectively ( P = 0.51 ; WMWodds 1.20 [ 0.69-2 .16 ] ) .
CONCLUSIONS	We found no evidence that varying volume and concentration while maintaining a fixed total dose of mepivacaine alters the onset time and duration of double-injection sciatic nerve block .
CONCLUSIONS	Considering our WMWodds results , possible differences in onset time and duration comparable to differences in the performance time between groups can not be excluded .

###24738648
OBJECTIVE	To investigate the effects of Thai traditional massage ( TTM ) on pressure pain threshold ( PPT ) and headache intensity in patients with chronic tension-type and migraine headaches .
METHODS	Randomized controlled trial of TTM compared with the sham ultrasound ( nine sessions each ) during a 3-week period .
METHODS	Seventy-two participants who had had a headache diagnosis for at least 3 months before the experiment was recruited .
RESULTS	After the treatment and at 3 and 9 weeks of follow-up , the TTM group showed a significant increase in PPT ( p < 0.01 ) compared with the sham ultrasound group .
RESULTS	PPT values at baseline , after 3 weeks of treatment , and at 3 - and 9-week follow-up for the TTM group were 2.71 1.22 , 3.57 1.41 , 3.72 1.46 , and 3.42 1.46 pounds/cm ( 2 ) , respectively ; values in the sham ultrasound group were 2.85 1.20 , 2.62 1.07 , 2.58 1.05 and 2.63 0.94 pounds/cm ( 2 ) .
RESULTS	In both groups , headache intensity decreased significantly ( p < 0.05 ) at every end point of the outcome measures , and there were no differences between the groups ( p > 0.05 ) .
CONCLUSIONS	TTM could increase PPT and reduce headache intensity , suggesting that this is a possible alternative treatment for chronic headaches .

###24269547
BACKGROUND	To evaluate the usefulness of capnography for early detection of respiratory depression during sedoanalgesia procedures in the pediatric emergency department .
BACKGROUND	To assess whether the administration of oxygen during the procedure can modify monitored parameters , thus delaying detection of respiratory depression .
METHODS	A prospective randomized study was performed on children between 1 year and 16 years who underwent sedoanalgesia to perform diagnostic or therapeutic procedures .
METHODS	They were randomized into two groups ( with or without supplemental oxygen ) .
METHODS	All patients were monitored by visual inspection , pulse-oximetry and non-invasive capnography .
METHODS	Monitoring was initiated prior to drug administration and continued until complete recovery of baseline .
METHODS	The main study variable was respiratory depression defined as apnea , hypoventilation or oxygen desaturation .
RESULTS	Twenty patients were included .
RESULTS	Eleven patients were randomized in the supplemental oxygen group .
RESULTS	This study showed a statistically significant elevation of EtCO2 levels at 5 , 10 and 15min , compared with baseline .
RESULTS	No significant change in the SatO2 mean was detected .
RESULTS	No statistically significant differences were identified when comparing etCO2 mean and SatO2 mean in both groups .
RESULTS	Two cases of respiratory depression were detected early by capnography .
RESULTS	There was a statistically significant correlation between etCO2 at 5 and 10min , and the degree of sedation achieved .
CONCLUSIONS	The inclusion of capnography to routine monitoring for adequate sedation procedures could improve safety .
CONCLUSIONS	Oxygen administration does not appear to modify the parameters monitored .

###25547339
BACKGROUND	Glycemic index and glycemic load are used to facilitate glucose control among adults with type 2 diabetes , with a low glycemic index diet associated with improved glycemic control .
OBJECTIVE	To examine long-term longitudinal associations between changes in glycemic index and glycemic load with glycemic and metabolic control among Latino adults with diabetes .
METHODS	Secondary data from intervention and comparison participants in the Latinos en Control trial ( 2006 to 2008 ) were analyzed .
METHODS	Data on dietary intake and metabolic characteristics were from low-income , Latino adults ( N = 238 ; 87.7 % Puerto Rican ) with type 2 diabetes .
METHODS	The Latinos en Control trial was a randomized clinical trial targeting diabetes self-management among Latinos with type 2 diabetes .
METHODS	Participants were randomized to a group-based behavioral intervention or usual care and followed through 12 months .
METHODS	Outcomes included hemoglobin A1c ( HbA1c ) levels , fasting blood glucose , lipid profiles , anthropometrics , and blood pressure .
METHODS	Glycemic index and load were analyzed using data from three 24-hour dietary recalls conducted at baseline , 4 months , and 12 months .
METHODS	Repeated measures regression models were used to examine change in glycemic index and load associated with metabolic characteristics at 12 months .
METHODS	Covariates included sex , age , body mass index , blood pressure , total energy intake , medication use and intensity , physical activity , intervention status ( intervention vs usual care ) , and time .
RESULTS	Increases in glycemic index from baseline to 12 months were associated with increased logarithm of HbA1c levels ( = 0.003 ; P = 0.034 ) and waist circumference ( = 0.12 ; P = 0.026 ) over time , but not with fasting glucose , blood lipids , or body mass index .
RESULTS	There was modest evidence to support small , positive associations between glycemic load and HbA1c levels and waist circumference .
CONCLUSIONS	Lowering glycemic index is associated with improvements in certain metabolic risk factors among Latinos with diabetes .
CONCLUSIONS	Targeting glycemic index may be an important component of dietary strategies for diabetes self-management .

###24491403
OBJECTIVE	To test whether communicating cardiovascular diseases ( CVD ) risk using a novel risk assessment tool ( Heart Age ) will be able to motivate a population to adopt healthier lifestyles and improve CVD risk profile over the use of a traditional percentage-based tool .
METHODS	A single-blind randomized intervention study was carried out in a Caucasian population .
METHODS	A total of 3153 subjects were randomly allocated to one of three study groups : control ( conventional medical advice was given to the subjects ) , Framingham REGICOR ( 10-year percentage risk score , calibrated to Spanish population was given to the subjects ) , or Heart Age group ( Heart Age tool was administered to the subjects ) .
METHODS	Anthropometrical and metabolic parameters were measured and lifestyle habits were recorded at recruitment and 12-months post intervention .
RESULTS	Both the Framingham REGICOR and the Heart Age intervention groups demonstrated significant decreases in their risk scores at post intervention compared to the control group , with the improvement being of a greater magnitude in the Heart Age group .
RESULTS	No differences per gender were observed in the Heart Age group .
CONCLUSIONS	Informing patients about their CVD risk expressed as the new Heart Age tool results in a reduction in their CVD risk higher than the one observed when the Framingham REGICOR risk score was used .

###26312955
OBJECTIVE	Tonsillectomy is one of the most common pediatric surgical procedures performed in the United States .
OBJECTIVE	The postoperative period can be particularly painful , and there is currently no consensus on an optimal analgesic regimen .
OBJECTIVE	The objective of this study was to evaluate efficacy and safety of the single drug tramadol versus codeine/acetaminophen post-tonsillectomy .
METHODS	Prospective , double-blinded , randomized controlled trial .
METHODS	Large , Midwestern US pediatric hospital .
METHODS	Eighty-four children aged 4-15 years who underwent a tonsillectomy ( with or without adenoidectomy ) procedure were randomized and 74 were included in the analysis .
METHODS	Group 1 received liquid codeine/acetaminophen for 10 days post-tonsillectomy ( 5 days scheduled , followed by 5 days as-needed ) .
METHODS	Group 2 received liquid tramadol for 10 days post-tonsillectomy ( 5 days scheduled , followed by 5 days as-needed ) .
METHODS	Efficacy and side effects were evaluated using a 10-day take-home diary that was completed by parents .
RESULTS	Children in both study arms reported adequate post-tonsillectomy pain management without significant differences between groups in pain scores .
RESULTS	Oversedation was significantly higher on the day of surgery in the codeine/acetaminophen group , and itching was experienced by significantly more children in the tramadol group during the postoperative period .
CONCLUSIONS	As part of multimodal analgesia , scheduled plus as-needed tramadol may be considered for children in the postoperative setting due to its analgesic properties , low potential for side effects , and good safety profile .

###25686683
OBJECTIVE	Thirty-six months of isoniazid preventive therapy ( 36IPT ) was superior to 6 months of IPT ( 6IPT ) in preventing tuberculosis ( TB ) among HIV-infected adults in Botswana .
OBJECTIVE	We assessed the posttrial durability of this benefit .
METHODS	A 36-month double-blind placebo controlled trial ( 1:1 randomization ) with recruitment between November 2004 and July 2006 and observation until June 2011 .
METHODS	One thousand , nine hundred and ninety-five participants were followed in eight public health clinics .
METHODS	Twenty-four percent had a tuberculin skin test 5mm ( TST-positive ) .
METHODS	A minimum CD4 lymphocyte count was not required for enrolment .
METHODS	Antiretroviral therapy ( ART ) was provided in accordance with Botswana guidelines ; 72 % of participants retained by June 2011 had initiated ART .
METHODS	Multivariable analysis using Cox regression analysis included treatment arm , TST status , ART as a time-dependent variable and CD4 cell count at baseline and updated at 36 months .
RESULTS	In the posttrial period , 2.13 and 2.14 per 100 person-years accumulated , whereas 0.93 and 1.13 % TB incidence rates were observed in the 36IPT and 6IPT arms , respectively ( P = 0.52 ) .
RESULTS	The crude hazard ratio of TB during the trial and posttrial was 0.57 [ 95 % confidence intervals ( CI ) 0.33 , 0.99 ] and 0.82 ( 95 % CI 0.46 , 1.49 ) , and when restricted to TST-positive participants was 0.26 ( 95 % CI 0.08 , 0.80 ) and 0.40 ( 95 % CI 0.15 , 1.08 ) , respectively .
RESULTS	Multivariable analysis showed that ART use was associated with reduced death ( adjusted hazard ratio 0.36 , 95 % CI 0.17-0 .75 ) but not TB ( 0.92 , 95 % CI 0.55-1 .53 ) in the posttrial period .
CONCLUSIONS	The benefit of 36IPT for TB prevention declined posttrial in this cohort .
CONCLUSIONS	Adjunctive measures are warranted to prevent TB among HIV-infected persons receiving long-term ART in TB-endemic settings .

###24743584
OBJECTIVE	To evaluate the short-term efficacy and safety of methoxyflurane for the treatment of acute pain in patients presenting to an emergency department ( ED ) with minor trauma .
METHODS	STOP !
METHODS	was a randomised , double-blind , multicentre , placebo-controlled study conducted at six sites in the UK .
METHODS	A total of 300 patients , 90 of whom were adolescent patients ( age 12-17 years ) , were randomised 150:150 to receive either methoxyflurane via a Penthrox inhaler or placebo .
METHODS	The primary end point of the study was the change in pain intensity as measured using the visual analogue scale ( VAS ) from baseline to 5 , 10 , 15 and 20 min after the start of study drug inhalation .
METHODS	Patients were supplied with one inhaler containing 3 mL methoxyflurane or 5 mL placebo after enrolment and initial assessments .
METHODS	Age group ( adolescent/adult ) and baseline VAS score were controlled for in the statistical analyses .
RESULTS	A total of 149 patients received methoxyflurane , and 149 patients received placebo .
RESULTS	Demographic and baseline characteristics were comparable between the groups .
RESULTS	Methoxyflurane reduced pain severity significantly more than placebo ( p < 0.0001 ) at all time points tested , with the greatest estimated treatment effect of -18.5 mm ( adjusted change from baseline ) seen at 15 min after the start of treatment .
RESULTS	Methoxyflurane was well tolerated , with the majority of adverse reactions being mild , transient and in line with anticipated pharmacological action .
CONCLUSIONS	The results of this study suggest that methoxyflurane administered via the Penthrox inhaler is an efficacious , safe , and rapidly acting analgesic .
BACKGROUND	NCT01420159 .

###25468186
BACKGROUND	Research has shown that paranoia may directly build on negative ideas about the self .
BACKGROUND	Feeling inferior can lead to ideas of vulnerability .
BACKGROUND	The clinical prediction is that decreasing negative self cognitions will reduce paranoia .
METHODS	Thirty patients with persistent persecutory delusions were randomised to receive brief CBT in addition to standard care or to standard care ( ISRCTN06118265 ) .
METHODS	The six session intervention was designed to decrease negative , and increase positive , self cognitions .
METHODS	Assessments at baseline , 8 weeks ( posttreatment ) and 12 weeks were carried out by a rater blind to allocation .
METHODS	The primary outcomes were posttreatment scores for negative self beliefs and paranoia .
METHODS	Secondary outcomes were psychological well-being , positive beliefs about the self , persecutory delusions , social comparison , self-esteem , anxiety , and depression .
RESULTS	Trial recruitment and retention were feasible and the intervention highly acceptable to the patients .
RESULTS	All patients provided follow-up data .
RESULTS	Posttreatment there was a small reduction in negative self beliefs ( Cohen 's d = 0.24 ) and a moderate reduction in paranoia ( d = 0.59 ) , but these were not statistically significant .
RESULTS	There were statistically significant improvements in psychological well-being ( d = 1.16 ) , positive beliefs about the self ( d = 1.00 ) , negative social comparison ( d = 0.88 ) , self-esteem ( d = 0.62 ) , and depression ( d = 0.68 ) .
RESULTS	No improvements were maintained .
RESULTS	No adverse events were associated with the intervention .
CONCLUSIONS	The intervention produced short-term gains consistent with the prediction that improving cognitions about the self will reduce persecutory delusions .
CONCLUSIONS	The improvement in psychological well-being is important in its own right .
CONCLUSIONS	We recommend that the different elements of the intervention are tested separately and that the treatment is lengthened .

###25900659
BACKGROUND	Tissue oxygenation is a strong predictor of surgical site infection .
BACKGROUND	Improving tissue oxygenation should thus reduce wound infection risk .
BACKGROUND	Supplemental inspired oxygen can improve tissue oxygenation , but whether it reduces infection risk remains controversial .
BACKGROUND	Low-dose dexamethasone is often given to reduce the risk of postoperative nausea and vomiting , but steroid-induced immunosuppression can increase infection risk .
BACKGROUND	We therefore tested the hypotheses that supplemental perioperative oxygen reduces infection risk and that dexamethasone increases it .
METHODS	Using a factorial design , patients having colorectal resections expected to last 2 h were randomly assigned to 30 % ( n = 270 ) or 80 % ( n = 285 ) inspired oxygen during and for 1 h after surgery , and to 4 mg intraoperative dexamethasone ( n = 283 ) or placebo ( n = 272 ) .
METHODS	Physicians blinded to group assignments evaluated wounds postoperatively , using US Centers for Disease Control criteria .
RESULTS	Subject and surgical characteristics were similar among study groups .
RESULTS	Surgical site infection incidence was similar among groups : 30 % oxygen 15.6 % , 80 % oxygen 15.8 % ( P = 1.00 ) ; dexamethasone 15.9 % , placebo 15.4 % , ( P = 0.91 ) .
CONCLUSIONS	Supplemental oxygen did not reduce surgical site infection risk .
CONCLUSIONS	The preponderance of clinical evidence suggests that administration of 80 % supplemental inspired oxygen does not reduce infection risk .
CONCLUSIONS	We did not observe an increased risk of surgical site infection with the use of a single low dose of dexamethasone , indicating that it can be used for nausea and vomiting prophylaxis without promoting wound infections .
BACKGROUND	ClinicalTrials.gov number : NCT00273377 .

###24401829
BACKGROUND	Mental practice using motor imagery of limb movement may facilitate motor recovery in persons who have experienced cerebrovascular accident ( CVA ) .
BACKGROUND	However , the lack of a feedback mechanism that can monitor the quality of the motor imagery affects patients ' engagement and motivation to participate in the mental practice training program .
OBJECTIVE	This study investigates the effect of novel real-time motor imagery-associated cortical activity feedback on motor imagery-based mental practice training .
METHODS	Ten healthy volunteers were randomly assigned into intervention and control groups .
METHODS	Both groups participated in a five-visit motor imagery-based mental practice training program managed over a period of two months .
METHODS	The intervention group received mental practice training with real-time feedback of movement-associated cortical activity-beta band ( 16-28 Hz ) event-related desynchronization ( ERD ) in electroencephalography ( EEG ) , using a novel custom-made brain-computer interface ( BCI ) system .
METHODS	The control group received the mental practice training program without EEG cortical feedback .
METHODS	Motor excitability was assessed by measuring the frequency power magnitude of the EEG rhythmic activity associated with physical execution of wrist extension before and after the motor imagery-based mental practice training .
RESULTS	The EEG frequency power magnitude associated with the physical execution of wrist extension was significantly lower ( i.e. more desynchronized ) after the mental practice training in the intervention group that received real-time cortical feedback ( P < 0.05 ) , whereas no significant difference in EEG frequency power magnitude associated with the physical execution of wrist extension was observed before and after mental practice training in the control group who did not receive feedback .
CONCLUSIONS	The mental practice training program with motor imagery-associated cortical feedback facilitated motor excitability during the production of voluntary motor control .
CONCLUSIONS	Motor imagery-based mental practice training with movement-associated cortical activity feedback may provide an effective strategy to facilitate motor recovery in brain injury patients , particularly during the early rehabilitation stage when full participation in physical and occupational therapy programs may not be possible due to excessive motor weakness .

###24405797
OBJECTIVE	To assess whether buccal misoprostol is effective for the treatment of intrauterine fetal death .
METHODS	This double-blind randomized trial was conducted at five tertiary-level hospitals in the United States and Vietnam .
METHODS	One hundred fifty-three women with an intrauterine fetal death at 14-28 weeks of pregnancy received either 100 mcg buccal misoprostol or 200 mcg buccal misoprostol every 6 h for a maximum of 8 doses .
METHODS	The main outcome measure was the fetal-placental delivery rate within 48 hours of prostaglandin commencement without any additional intervention .
RESULTS	Most of the women ( 140/153 ) were recruited at the study site in Vietnam .
RESULTS	Expulsion of both fetus and placenta within 48 hours of prostaglandin commencement without any additional interventions occurred in 61.8 % ( 47/76 ) of women receiving misoprostol 100 mcg and 77.9 % ( 60/77 ) of women receiving misoprostol 200 mcg .
RESULTS	The 200 mcg dose was significantly more effective than the 100 mcg dose at expelling the fetus and placenta within 48 h [ RR 0.68 ( 95 % CI : 0.50-0 .92 ; p = .03 ) ] .
RESULTS	The mean time to expulsion was significantly shorter using the 200 mcg dose ( 18.511.9 h ) than the 100 mcg dose ( 23.912.5 h ) ( p = .02 ) .
RESULTS	Most women in both groups found the procedure satisfactory or very satisfactory ( 100 mcg : 76.7 % ( 56/73 ) ; 200 mcg : 89.5 % ( 68/76 ) [ RR 0.86 ( 95 % CI : 0.74-1 .00 ) ] .
CONCLUSIONS	Buccal misoprostol is an effective method for medical induction of labor after intrauterine fetal demise .
CONCLUSIONS	A 200 mcg dose is significantly more effective than 100 mcg for evacuating the uterus within 48h .
CONCLUSIONS	The treatment is highly acceptable to women .
CONCLUSIONS	Administration of 200 mcg buccal misoprostol every six hours is an effective and acceptable method to effect the delivery of a demised fetus at 14-28 weeks that can be feasibly implemented in a wide variety of settings .

###24918371
BACKGROUND	Obesity and obstructive sleep apnea tend to coexist and are associated with inflammation , insulin resistance , dyslipidemia , and high blood pressure , but their causal relation to these abnormalities is unclear .
METHODS	We randomly assigned 181 patients with obesity , moderate-to-severe obstructive sleep apnea , and serum levels of C-reactive protein ( CRP ) greater than 1.0 mg per liter to receive treatment with continuous positive airway pressure ( CPAP ) , a weight-loss intervention , or CPAP plus a weight-loss intervention for 24 weeks .
METHODS	We assessed the incremental effect of the combined interventions over each one alone on the CRP level ( the primary end point ) , insulin sensitivity , lipid levels , and blood pressure .
RESULTS	Among the 146 participants for whom there were follow-up data , those assigned to weight loss only and those assigned to the combined interventions had reductions in CRP levels , insulin resistance , and serum triglyceride levels .
RESULTS	None of these changes were observed in the group receiving CPAP alone .
RESULTS	Blood pressure was reduced in all three groups .
RESULTS	No significant incremental effect on CRP levels was found for the combined interventions as compared with either weight loss or CPAP alone .
RESULTS	Reductions in insulin resistance and serum triglyceride levels were greater in the combined-intervention group than in the group receiving CPAP only , but there were no significant differences in these values between the combined-intervention group and the weight-loss group .
RESULTS	In per-protocol analyses , which included 90 participants who met prespecified criteria for adherence , the combined interventions resulted in a larger reduction in systolic blood pressure and mean arterial pressure than did either CPAP or weight loss alone .
CONCLUSIONS	In adults with obesity and obstructive sleep apnea , CPAP combined with a weight-loss intervention did not reduce CRP levels more than either intervention alone .
CONCLUSIONS	In secondary analyses , weight loss provided an incremental reduction in insulin resistance and serum triglyceride levels when combined with CPAP .
CONCLUSIONS	In addition , adherence to a regimen of weight loss and CPAP may result in incremental reductions in blood pressure as compared with either intervention alone .
CONCLUSIONS	( Funded by the National Heart , Lung , and Blood Institute ; ClinicalTrials.gov number , NCT0371293 . )

###25261492
BACKGROUND	Circumcision and lower human papillomavirus ( HPV ) viral loads in men are possibly associated with a reduced risk of HPV transmission to women .
BACKGROUND	However , the association between male circumcision and HPV viral load remains unclear .
METHODS	Swab specimens from the glans and shaft of the penis were collected from men enrolled in a circumcision trial in Kisumu , Kenya .
METHODS	GP5 + / 6 + polymerase chain reaction ( PCR ) was used to identify HPV DNA types .
METHODS	HPV-16 and HPV-18 loads were measured with a LightCycler real-time PCR and classified as high ( > 250 copies/scrape ) or low ( 250 copies/scrape ) .
RESULTS	A total of 1159 men were randomly assigned to undergo immediate circumcision , and 1140 men were randomly assigned to the control arm ( these individuals were asked to remain uncircumcised until the study ended ) .
RESULTS	The hazard of acquisition of high-viral load infections in the glans was lower in the circumcision arm , compared with the control arm , for HPV-16 ( hazard ratio [ HR ] , 0.32 [ 95 % confidence interval { CI } , .20 -.49 ] ) and HPV-18 ( HR , 0.34 [ 95 % CI , .21 -.54 ] ) .
RESULTS	The 6-month risk of HPV persistence among men with high-viral load infections in the glans at baseline was lower in the circumcision arm , compared with the control arm , for HPV-16 ( risk ratio [ RR ] , 0.36 [ 95 % CI , .18 -.72 ] ) and HPV-18 ( RR 0.34 [ 95 % CI , .13 -.86 ] ) .
RESULTS	Weaker and less precise results were obtained for shaft samples .
CONCLUSIONS	Male circumcision could potentially reduce the risk of HPV transmission to women by reducing the hazard of acquisition , and the risk of persistence of high-HPV viral load infections in the glans in men .

###24699052
OBJECTIVE	Previous cell-based and animal studies showed mixed tocotrienols are neuroprotective , but the effect is yet to be proven in humans .
OBJECTIVE	Thus , the present study aimed to evaluate the protective activity of mixed tocotrienols in humans with white matter lesions ( WMLs ) .
OBJECTIVE	WMLs are regarded as manifestations of cerebral small vessel disease , reflecting varying degrees of neurodegeneration and tissue damage with potential as a surrogate end point in clinical trials .
METHODS	A total of 121 volunteers aged 35 years with cardiovascular risk factors and MRI-confirmed WMLs were randomized to receive 200 mg mixed tocotrienols or placebo twice a day for 2 years .
METHODS	The WML volumes were measured from MRI images taken at baseline , 1 year , and 2 years using a validated software and were compared .
METHODS	Fasting blood samples were collected for full blood chemistry investigation .
RESULTS	According to per-protocol ( 88 volunteers ) and intention-to-treat ( 121 volunteers ) analyses , the mean WML volume of the placebo group increased after 2 years , whereas that of the tocotrienol-supplemented group remained essentially unchanged .
RESULTS	The mean WML volume change between the 2 groups was not significantly different ( P = 0.150 ) at the end of 1 year but was significant at the end of 2 years for both per-protocol and intention-to-treat analyses ( P = 0.019 and P = 0.018 ) .
RESULTS	No significant difference was observed in the blood chemistry parameters between the 2 groups .
CONCLUSIONS	Mixed tocotrienols were found to attenuate the progression of WMLs .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00753532 .

###25336916
BACKGROUND	Fimasartan is a novel angiotensin II receptor blocker .
BACKGROUND	Fimasartan is mainly eliminated via biliary excretion , and its urinary elimination is less than 3 % .
OBJECTIVE	Based on guidance from the United States Food and Drug Administration , a reduced pharmacokinetic ( PK ) study was conducted to evaluate the effect of renal function on the PK of fimasartan in patients with renal impairment and healthy volunteers .
METHODS	A single centre , single-dose , open-label , healthy volunteer controlled trial was conducted in patients with renal impairment ( RI ) ( estimated glomerular filtration rate lower than 30 mL/min/1 .73 m ( 2 ) ) and age - , weight - and sex-matched healthy volunteers ( estimated glomerular filtration rate higher than 90 mL/min/1 .73 m ( 2 ) ) .
METHODS	All participants received a single oral dose of fimasartan 120 mg , after which serial blood sampling for PK evaluation was conducted .
METHODS	Noncompartmental PK analysis of fimasartan was performed .
METHODS	A mixed-effects model approach was used to identify significant covariates and PK parameters .
RESULTS	Sixteen subjects were enrolled ( 8 healthy volunteers and 8 RI patients ) .
RESULTS	The maximum plasma concentrations and areas under the plasma concentration curves of the RI patients were higher than those of the healthy volunteers , with geometric mean ratios of 1.87 and 1.73 , respectively .
RESULTS	The relative bioavailability of fimasartan from the population PK analysis was 77 % higher in the RI patients than in the healthy volunteers .
CONCLUSIONS	The increased drug exposure of fimasartan in RI patients was explained by the increased relative bioavailability .
CONCLUSIONS	This result can be explained from our knowledge concerning alterations in PK related to renal function .

###24461794
OBJECTIVE	Milk may stimulate growth acting via insulin-like growth factor-I ( IGF-I ) secretion but the effect in adolescents is less examined .
OBJECTIVE	This study investigates the effect of milk proteins on linear growth , IGF-I , IGF binding protein-3 ( IGFBP-3 ) and IGF-I/IGFBP -3 ratio in overweight adolescents .
METHODS	The trial included 193 overweight adolescents aged 12-15 years .
METHODS	They were randomized to drink 1L/day of : skimmed milk , whey , casein or water for 12 weeks ; all milk-based drinks contained 35 g protein/L .
METHODS	A subgroup of 32 adolescents was examined 12 weeks before they were randomized into the groups and started the intervention ( pre-test control group ) .
METHODS	Examinations included anthropometry , diet registration and blood samples which were analyzed for IGF-I and IGFBP-3 by chemiluminescence methods .
METHODS	The effects of milk-based drinks on linear growth , IGF-I , IGFBP-3 and IGF-I availability , calculated as the IGF-I/IGFBP -3 ratio , were compared with baseline , the pre-test control group and water .
RESULTS	IGF-I increased with skimmed milk ( P = 0.015 ) and tended to increase with casein ( P = 0.075 ) compared to the pre-test control group .
RESULTS	IGFBP-3 but not IGF-I increased with skimmed milk ( P = 0.006 ) and casein ( P = 0.001 ) compared to water .
RESULTS	There was no difference in height or height Z-score for any of the milk-based test drink groups compared to water or compared to the pre-test control group .
RESULTS	However , height Z-score decreased within the whey group .
CONCLUSIONS	Skimmed milk and casein may have a stimulating effect on the IGF-I system whereas there was no positive effect on height in overweight adolescents during this 12 week intervention .

###24717759
OBJECTIVE	Mutations in lipoprotein-associated phospholipase A2 ( Lp-PLA2 ) are related to atherosclerosis .
OBJECTIVE	However , the molecular effects of Lp-PLA2 on atherosclerosis have not been fully investigated .
OBJECTIVE	Therefore , this study attempted to elucidate this issue .
METHODS	Monocytes were isolated from randomly selected healthy male volunteers according to each Lp-PLA2 genotype ( wild-type Lp-PLA2 [ Lp-PLA2 ( V/V ) ] , the heterozygous V279F mutation [ LpPLA2 ( V/F ) ] and the homozygous V279F mutation [ Lp-PLA2 ( F/F ) ] ) and differentiated into macrophages .
METHODS	The level of apoptosis in the macrophages following incubation without serum was measured using the annexin V/propidium iodide double staining method , and the underlying mechanisms were further examined using a culture cell line .
RESULTS	The average plasma Lp-PLA2 concentration [ Lp-PLA2 ( V/V ) : 129.4 ng/mL , Lp-PLA2 ( V/F ) : 70.7 ng/mL , Lp-PLA2 ( F/F ) : 0.4 ng/mL ] and activity [ Lp-PLA2 ( V/V ) : 164.3 nmol/min/mL , LpPLA2 ( V/F ) : 100.9 nmol/min/mL , Lp-PLA2 ( F/F ) : 11.6 nmol/min/mL ] were significantly different between each genotype , although the basic clinical characteristics were similar .
RESULTS	The percentage of apoptotic cells was significantly higher among the Lp-PLA2 ( F/F ) macrophages compared with that observed in the Lp-PLA2 ( V/V ) macrophages .
RESULTS	This induction of apoptosis was independent of the actions of acetylated low-density lipoproteins .
RESULTS	In addition , the transfection of the expression plasmid of V279F mutant Lp-PLA2 into Cos-7 cells or monocyte/macrophage-like U937 cells promoted apoptosis .
RESULTS	The knockdown of Lp-PLA2 also increased the number of apoptotic cells .
RESULTS	Among the cells expressing mutant Lp-PLA2 , the caspase-7 activity was increased , while the activated Akt level was decreased .
CONCLUSIONS	The V279F mutation of Lp-PLA2 positively regulates the induction of apoptosis in macrophages and Cos-7 cells .
CONCLUSIONS	An increase in the caspase-7 activity and a reduction in the activated Akt level are likely to be involved in this phenomenon .

###24612478
BACKGROUND	Female libido is multifactorial and complex .
BACKGROUND	Declining estrogen levels in postmenopausal women affects vaginal function .
OBJECTIVE	The aim of this study was to evaluate female sexual function after using topical estrogen , testosterone , or polyacrylic acid as vaginal lubricants with K-Y jelly as a placebo lubricant .
METHODS	This was a randomized controlled clinical trial on 80 postmenopausal women between 40 and 70 years of age with follow-up at the Menopause Clinic of the CAISM Unicamp .
METHODS	The women were randomized to treatment with topical vaginal estrogen , testosterone , polyacrylic acid , or oil lubricant alone , three times a week for a period of 12 weeks from November 2011 to January 2013 .
METHODS	We used the Female Sexual Function Index ( FSFI ) to assess changes in sexual response at baseline , and after 6 and 12 weeks .
RESULTS	After 12 weeks of treatment , polyacrylic acid and topical testosterone produced improvements in the FSFI domains of sexual desire , lubrication , satisfaction , reduced pain during intercourse , and total score compared with lubricant alone .
RESULTS	Treatment with topical estrogen in comparison with lubricant alone showed an improvement in the FSFI field of desire .
RESULTS	The intragroup analysis over the time of the treatment showed improvements in the fields of desire , lubrication , and reduced pain for polyacrylic acid , testosterone , and estrogen .
RESULTS	Furthermore , women who used testosterone showed improvements over time in the fields of arousal , orgasm , and satisfaction .
CONCLUSIONS	Treatment of postmenopausal women with symptoms of vaginal atrophy with polyacrylic acid , testosterone , and estrogen for 12 weeks produced improvements in self-reported female sexual function when compared with a placebo lubricant .

###25128411
BACKGROUND	The rate of falls in community dwelling older people with cognitive impairment ( CI ) is twice that of a cognitively intact population , with almost two thirds of people with CI falling annually .
BACKGROUND	Studies indicate that exercise involving balance and/or a home hazard reduction program are effective in preventing falls in cognitively intact older people .
BACKGROUND	However the potential benefit of these interventions in reducing falls in people with CI has not been established.This randomised controlled trial will determine whether a tailored exercise and home hazard reduction program can reduce the rate of falls in community dwelling older people with CI .
BACKGROUND	We will determine whether the intervention has beneficial effects on a range of physical and psychological outcome measures as well as quality of life of participants and their carers .
BACKGROUND	A health economic analysis examining the cost and potential benefits of the program will also be undertaken .
METHODS	Three hundred and sixty people aged 65years or older living in the community with CI will be recruited to participate in the trial .
METHODS	Each will have an identifiable carer with a minimum of 3.5 hours of face to face contact each week.Participants will undergo an assessment at baseline with retests at 6 and 12months .
METHODS	Participants allocated to the intervention group will participate in an exercise and home hazard reduction program tailored to their cognitive and physical abilities.The primary outcome measure will be the rate of falls which will be measured using monthly falls calendars .
METHODS	Secondary outcome measures will include the risk of falling , quality of life , measures of physical and cognitive function , fear of falling and planned and unplanned use of health services .
METHODS	Carers will be followed up to determine carer burden , coping strategies and quality of life .
CONCLUSIONS	The study will determine the impact of this tailored intervention in reducing the rate of falls in community dwelling older people with CI as well as the cost-effectiveness and adherence to the program .
CONCLUSIONS	The results will have direct implications for the design and implementation of interventions for this high-risk group of older people .
BACKGROUND	The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry - ACTRN12614000603617 .

###24839145
OBJECTIVE	The aim of the article is to determine whether maternal body mass index ( BMI ) influences the beneficial effects of diabetes treatment in women with gestational diabetes mellitus ( GDM ) .
METHODS	Secondary analysis of a multicenter randomized treatment trial of women with GDM .
METHODS	Outcomes of interest were elevated umbilical cord c-peptide levels ( > 90th percentile 1.77 ng/mL ) , large for gestational age ( LGA ) birth weight ( > 90th percentile ) , and neonatal fat mass ( g ) .
METHODS	Women were grouped into five BMI categories adapted from the World Health Organization International Classification of normal , overweight , and obese adults .
METHODS	Outcomes were analyzed according to treatment group assignment .
RESULTS	A total of 958 women were enrolled ( 485 treated and 473 controls ) .
RESULTS	Maternal BMI at enrollment was not related to umbilical cord c-peptide levels .
RESULTS	However , treatment of women in the overweight , Class I , and Class II obese categories was associated with a reduction in both LGA birth weight and neonatal fat mass .
RESULTS	Neither measure of excess fetal growth was reduced with treatment in normal weight ( BMI < 25 kg/m ( 2 ) ) or Class III ( BMI40 kg/m ( 2 ) ) obese women .
CONCLUSIONS	There was a beneficial effect of treatment on fetal growth in women with mild GDM who were overweight or Class I and Class II obese .
CONCLUSIONS	These effects were not apparent for normal weight and very obese women .

###24606070
BACKGROUND	Low levels of adiponectin and T in men have been shown to predict development of the metabolic syndrome , but the effects of T on glucose metabolism are incompletely understood and may be influenced either directly or indirectly through changes in body composition or in levels of adiponectin .
OBJECTIVE	The aim of the study was to test whether T exerts its effects on glucose metabolism directly or indirectly .
METHODS	In a randomized , double-blind , placebo-controlled , crossover study , 12 healthy young males were studied on four separate occasions .
METHODS	They received GnRH agonist treatment 1 month before 3 of 4 trial days to induce castrate levels of T. On trial days , T gel containing either high or low physiological T dose or placebo was applied to the body .
METHODS	On a fourth trial day , participants constituted their own eugonadal controls .
METHODS	Each study comprised a 5-hour basal period and a 3-hour hyperinsulinemic euglycemic clamp .
METHODS	We measured the effect of acute T on peripheral glucose disposal , total adiponectin and subforms , and other indices of glucose metabolism .
RESULTS	Short-term hypogonadism was associated with increased high molecular weight adiponectin levels ( P < .03 ) and increased oxidative glucose disposal ( P = .03 ) but not total glucose disposal ( P = .07 ) .
RESULTS	Acute T treatment was an independent suppressor of high molecular weight adiponectin levels ( P = .04 ) but did not affect total glucose disposal ( P = .17 ) .
CONCLUSIONS	These data show that T can act through putative fast nongenomic pathways to affect adiponectin levels in humans .
CONCLUSIONS	The early hypogonadal state is characterized by a marked shift in fuel oxidation from lipids toward glucose , which may rely partly on buffering capabilities of adiponectin .

###24553478
OBJECTIVE	The effectiveness of axillary brachial plexus block ( ABPB ) performed using peripheral nerve stimulation ( PNS ) alone was compared with PNS preceded by nerve localization using a pen device , enabling nerve mapping without puncturing the skin .
METHODS	Patients undergoing unilateral hand or forearm surgery suitable for ABPB were randomly assigned to receive either PNS alone ( pen - group ) or PNS preceded by nerve localization using a pen device ( pen + group ) .
METHODS	Parameters related to the block procedure and patient comfort were assessed .
RESULTS	Thirty patients were included in each group .
RESULTS	The block performance time was longer in the pen + group than the pen - group despite a reduced number of needle insertions .
RESULTS	The complete block rate was higher and intraoperative analgesic usage lower in the pen + group compared with the pen - group .
RESULTS	Patient satisfaction and complication rates were similar in the two groups .
CONCLUSIONS	The pen device seems to be a helpful addition to PNS for ABPB , with improved results in terms of block success and patient comfort , but further studies are needed to confirm these findings .

###24553281
OBJECTIVE	The purpose of this study was to investigate the effectiveness of a 10 percent casein phosphopeptide-amorphous calcium phosphate ( CPP-ACP ) cream to reduce mutans streptococci ( MS ) colonization and prevent early childhood caries .
METHODS	The cohort was randomized at mean age of 11 days old to receive once-daily CPP-ACP cream ( n = 102 ) or no product ( comparison group ; n = 89 ) from the time of first tooth eruption .
METHODS	All mothers were contacted by telephone at six , 12 , and 18 months and advised to brush their children 's teeth twice daily with low-dose fluoride toothpaste .
METHODS	At 24 months , all children were examined at a community clinic .
RESULTS	At 24 months old , one out of 65 ( 2 percent ) children in the CPP-ACP group had caries vs. four out of 58 ( seven percent ) in the comparison group ( difference not statistically significant ) .
RESULTS	There were fewer MS-positive children in the CPP-ACP group ( 26 percent ) vs. the comparison group ( 47 percent ; P = .02 ) .
RESULTS	A dose-response effect of CPP-ACP usage on MS was observed , where MS was present in eight percent of regular CPP-ACP users , 28 percent of irregular users , and 47 percent of non-users ( P < .02 ) .
CONCLUSIONS	CPP-ACP reduced the percentages of mutans streptococci-positive 24-month-old children , although it did not reduce caries prevalence .

###25516025
OBJECTIVE	To test the cost-effectiveness of a home-based depression program : Beat the Blues ( BTB ) .
METHODS	A cost-effectiveness analysis as part of a previously reported randomized controlled trial that compared BTB with a wait-list control group .
METHODS	Community .
METHODS	English-speaking , cognitively intact ( Mini-Mental State Examination score 24 ) , African Americans aged 55 and older with depressive symptoms ( Patient Health Questionnaire score 5 ) ( N = 129 ) .
METHODS	Participants randomly assigned to BTB received up to 10 home visits over 4 months from licensed social workers who provided care management , referral and linkage , stress reduction , depression education , and behavioral activation to help participants achieve self-identified goals .
METHODS	Incremental cost-effectiveness ratios ( ICERs ) of BTB versus wait-list controls during the 4-month study period .
METHODS	The primary ICER was defined as cost per quality-adjusted life year ( QALY ) using the Euro Quality of Life 5D ( EQ-5D ) and secondarily using the Health Utilities Index-3 ( HUI-3 ) .
METHODS	Additional ICERs were calculated using clinical measures ( cost per depression improvement , cost per depression remission ) .
METHODS	Costs included BTB intervention , depression-related healthcare visits and medications , caregiver time , and social services .
RESULTS	BTB cost per participant per month was $ 146 .
RESULTS	Base case ICERs were $ 64,896 per QALY ( EQ-5D ) and $ 36,875 per QALY ( HUI-3 ) .
RESULTS	Incremental cost was $ 2,906 per depression improvement and $ 3,507 per remission .
RESULTS	Univariate and probabilistic sensitivity analyses yielded a cost/QALY range of $ 20,500 to $ 76,500 .
CONCLUSIONS	Based on the range of cost-effectiveness values resulting from this study , BTB is a cost-effective treatment for managing depressive symptoms in older African Americans that compares favorably with the cost-effectiveness of previously tested approaches .

###25282598
BACKGROUND	Most patients relapse to opioids within one month of opioid agonist detoxification , making the antecedents and parallel processes of first use critical for investigation .
BACKGROUND	Craving and withdrawal are often studied in relationship to opioid outcomes , and a novel analytic strategy applied to these two phenomena may indicate targeted intervention strategies .
METHODS	Specifically , this secondary data analysis of the Prescription Opioid Addiction Treatment Study used a discrete-time mixture analysis with time-to-first opioid use ( survival ) simultaneously predicted by craving and withdrawal growth trajectories .
METHODS	This analysis characterized heterogeneity among prescription opioid-dependent individuals ( N = 653 ) into latent classes ( i.e. , latent class analysis [ LCA ] ) during and after buprenorphine/naloxone stabilization and taper .
RESULTS	A 4-latent class solution was selected for overall model fit and clinical parsimony .
RESULTS	In order of shortest to longest time-to-first use , the 4 classes were characterized as 1 ) high craving and withdrawal , 2 ) intermediate craving and withdrawal , 3 ) high initial craving with low craving and withdrawal trajectories and 4 ) a low initial craving with low craving and withdrawal trajectories .
RESULTS	Odds ratio calculations showed statistically significant differences in time-to-first use across classes .
CONCLUSIONS	Generally , participants with lower baseline levels and greater decreases in craving and withdrawal during stabilization combined with slower craving and withdrawal rebound during buprenorphine taper remained opioid-free longer .
CONCLUSIONS	This exploratory work expanded on the importance of monitoring craving and withdrawal during buprenorphine induction , stabilization , and taper .
CONCLUSIONS	Future research may allow individually tailored and timely interventions to be developed to extend time-to-first opioid use .

###24863570
BACKGROUND	Acne keloidalis nuchae ( AKN ) is a chronic scarring folliculitis with fibrotic papules on the occipital scalp .
BACKGROUND	Its treatment is limited and unsatisfactory .
OBJECTIVE	To determine whether targeted ultraviolet B ( tUVB ) phototherapy will ( i ) improve the clinical appearance of AKN and ( ii ) induce extracellular matrix remodelling in affected lesions .
METHODS	Eleven patients with AKN were enrolled in a prospective , randomized , split-scalp comparison study .
METHODS	One randomly selected side of the scalp was treated with tUVB up to three times weekly for 8weeks .
METHODS	After week 8 , both sides were treated for eight additional weeks .
METHODS	Assessment included lesion counts in two 33-cm regions of interest ( ROIs ) , one on each side of the scalp ( ROI-1 : tUVB weeks 0-16 , ROI-2 : tUVB weeks 9-16 ) , patient self-assessment and analysis of MMP1 , MMP9 , TGFB1 and COL1A1 mRNA expression by quantitative reverse-transcription polymerase chain reaction .
RESULTS	Before treatment , the mean lesion count was similar between tUVB-treated and untreated sides ( 148 vs. 150 ) .
RESULTS	After 8weeks of tUVB , the mean lesion count decreased significantly to 9412 ( P = 003 ) , with no change on the untreated side .
RESULTS	With continued treatment , the mean lesion count in ROI-1 decreased further to 715 ( P = 004 ) after 16weeks of tUVB .
CONCLUSIONS	tUVB significantly improved the clinical appearance of AKN , led to patient satisfaction and was well tolerated .

###24886455
BACKGROUND	Carpal tunnel syndrome ( CTS ) is a common condition ( prevalence of 4 % ) where the median nerve is compressed within the carpal tunnel resulting in numbness , tingling , and pain in the hand .
BACKGROUND	Current non-surgical treatment options ( oral medication , corticosteroid injections , splinting , exercise , and mobilization ) show limited effects , especially in the long-term .
BACKGROUND	Carpal tunnel release ( CTR ) surgery is effective in 70 to 75 % of patients , but is relatively invasive and can be accompanied by complications .
BACKGROUND	In an observational study , mechanical traction proved to be effective in up to 70 % of patients directly after treatment and in 60 % after two years follow-up .
BACKGROUND	This randomized controlled trial ( RCT ) will examine the effectiveness of mechanical traction compared to care as usual in CTS .
METHODS	Patients diagnosed with CTS will be recruited from an outpatient neurology clinic and randomly assigned to the intervention group ( mechanical traction ) or the control group ( care as usual ) .
METHODS	Participants in the intervention group will receive 12 treatments with mechanical traction during six consecutive weeks .
METHODS	Primary outcome is symptom severity and functional status , which are measured with the Boston Carpel Tunnel Questionnaire ( BCTQ ) .
METHODS	Secondary outcomes are quality of life ( WHOQOL-BREF ) , health related resource utilization , and absenteeism from work .
METHODS	Outcomes will be assessed at baseline , and at 3 , 6 , and 12months after inclusion .
METHODS	Linear mixed effect models will be used to determine the change from baseline at 12months on the BCTQ , WHOQOL-BREF , absenteeism from work and health related resource utilization .
METHODS	The baseline measurement , change from baseline at three and six months , as well as duration of symptoms until inclusion , age , gender , and co-morbidity will be included as covariates The Pearson 's correlation coefficient will be generated to assess the correlation between depression and anxiety and treatment outcome .
CONCLUSIONS	Since current non-surgical treatment options are not effective long-term and CTR is relatively invasive , there is a need for an effective and non-invasive treatment option .
CONCLUSIONS	Mechanical traction is a safe treatment option that may provide a good alternative for the usual care .
CONCLUSIONS	Considering the prevalence of CTS , the study is of great clinical value to a large patient population .
BACKGROUND	Clinical Trials NL44692 .008.13 ( registered on 19 September 2013 ) .

###24728665
BACKGROUND	Effective prophylactic therapies have not been established for hepatocellular carcinoma recurrence .
BACKGROUND	Peretinoin represents one novel option for patients with hepatitis C virus-related hepatocellular carcinoma ( HCV-HCC ) , and it was tested in a multicenter , randomized , double-blind , placebo-controlled study .
METHODS	Patients with curative therapy were assigned to one of the following regimens : peretinoin 600 , 300 mg/day , or placebo for up to 96 weeks .
METHODS	The primary outcome was recurrence-free survival ( RFS ) .
RESULTS	Of the 401 patients initially enrolled , 377 patients were analyzed for efficacy .
RESULTS	The RFS rates in the 600-mg group , the 300-mg group , and the placebo group were 71.9 , 63.6 , and 66.0 % at 1 year , and 43.7 , 24.9 , and 29.3 % at 3 years , respectively .
RESULTS	The primary comparison of peretinoin ( 300 and 600-mg ) with placebo was not significant ( P = 0.434 ) .
RESULTS	The dose-response relationship based on the hypothesis that `` efficacy begins to increase at 600 mg/day '' was significant ( P = 0.023 , multiplicity-adjusted P = 0.048 ) .
RESULTS	The hazard ratios for RFS in the 600-mg group vs. the placebo group were 0.73 [ 95 % confidence interval ( CI ) 0.51-1 .03 ] for the entire study period and 0.27 ( 95 % CI 0.07-0 .96 ) after 2 years of the randomization .
RESULTS	Common adverse events included ascites , increased blood pressure , headache , presence of urine albumin , and increased transaminases .
CONCLUSIONS	Although the superiority of peretinoin to placebo could not be validated , 600 mg/day was shown to be the optimal dose , and treatment may possibly reduce the recurrence of HCV-HCC , particularly after 2 years .
CONCLUSIONS	The efficacy and safety of peretinoin 600 mg/day should continue to be evaluated in further studies .

###25231491
BACKGROUND	Postoperative delirium is one of the most common complications of major surgery , affecting 10-70 % of surgical patients 60 years and older .
BACKGROUND	Delirium is an acute change in cognition that manifests as poor attention and illogical thinking and is associated with longer intensive care unit ( ICU ) and hospital stay , long-lasting cognitive deterioration and increased mortality .
BACKGROUND	Ketamine has been used as an anaesthetic drug for over 50 years and has an established safety record .
BACKGROUND	Recent research suggests that , in addition to preventing acute postoperative pain , a subanaesthetic dose of intraoperative ketamine could decrease the incidence of postoperative delirium as well as other neurological and psychiatric outcomes .
BACKGROUND	However , these proposed benefits of ketamine have not been tested in a large clinical trial .
METHODS	The Prevention of Delirium and Complications Associated with Surgical Treatments ( PODCAST ) study is an international , multicentre , randomised controlled trial .
METHODS	600 cardiac and major non-cardiac surgery patients will be randomised to receive ketamine ( 0.5 or 1 mg/kg ) or placebo following anaesthetic induction and prior to surgical incision .
METHODS	For the primary outcome , blinded observers will assess delirium on the day of surgery ( postoperative day 0 ) and twice daily from postoperative days 1-3 using the Confusion Assessment Method or the Confusion Assessment Method for the ICU .
METHODS	For the secondary outcomes , blinded observers will estimate pain using the Behavioral Pain Scale or the Behavioral Pain Scale for Non-Intubated Patients and patient self-report .
BACKGROUND	The PODCAST trial has been approved by the ethics boards of five participating institutions ; approval is ongoing at other sites .
BACKGROUND	Recruitment began in February 2014 and will continue until the end of 2016 .
BACKGROUND	Dissemination plans include presentations at scientific conferences , scientific publications , stakeholder engagement and popular media .
BACKGROUND	The study is registered at clinicaltrials.gov , NCT01690988 ( last updated March 2014 ) .
BACKGROUND	The PODCAST trial is being conducted under the auspices of the Neurological Outcomes Network for Surgery ( NEURONS ) .
BACKGROUND	NCT01690988 ( last updated December 2013 ) .

###25827292
BACKGROUND	Malnutrition is common in patients with advanced epithelial ovarian cancer ( EOC ) , and is associated with impaired quality of life ( QoL ) , longer hospital stay and higher risk of treatment-related adverse events .
BACKGROUND	This phase III multi-centre randomised clinical trial tested early enteral feeding versus standard care on postoperative QoL .
METHODS	From 2009 to 2013 , 109 patients requiring surgery for suspected advanced EOC , moderately to severely malnourished were enrolled at five sites across Queensland and randomised to intervention ( n = 53 ) or control ( n = 56 ) groups .
METHODS	Intervention involved intraoperative nasojejunal tube placement and enteral feeding until adequate oral intake could be maintained .
METHODS	Despite being randomised to intervention , 20 patients did not receive feeds ( 13 did not receive the feeding tube ; 7 had it removed early ) .
METHODS	Control involved postoperative diet as tolerated .
METHODS	QoL was measured at baseline , 6weeks postoperatively and 30days after the third cycle of chemotherapy .
METHODS	The primary outcome measure was the difference in QoL between the intervention and the control group .
METHODS	Secondary endpoints included treatment-related adverse event occurrence , length of stay , postoperative services use , and nutritional status .
RESULTS	Baseline characteristics were comparable between treatment groups .
RESULTS	No significant difference in QoL was found between the groups at any time point .
RESULTS	There was a trend towards better nutritional status in patients who received the intervention but the differences did not reach statistical significance except for the intention-to-treat analysis at 7days postoperatively ( 11.8 intervention vs. 13.8 control , p 0.04 ) .
CONCLUSIONS	Early enteral feeding did not significantly improve patients ' QoL compared to standard of care but may improve nutritional status .

###24495365
BACKGROUND	As healthcare services become progressively more stretched , there is increasing discussion of ways in which technological adjuncts may be used to deliver more cost-efficient services .
BACKGROUND	Before widespread implementation , however , the use of these adjuncts requires proper scrutiny of their effects on psychological practice .
OBJECTIVE	This research examined the effectiveness of SMS reminders on client appointment attendance and dropout in a psychological treatment setting .
OBJECTIVE	It was predicted that the reminders would result in increased initial appointment attendance , increased total appointment attendance , and decreased client dropout .
METHODS	A randomized controlled trial investigated the impact of SMS appointment reminders ( two levels : present or absent ) on client attendance ( three levels : attended , rescheduled , or did not attend ) and dropout ( two levels : completed treatment or terminate early ) .
METHODS	Participants ( N = 140 ) at an outpatient psychology clinic were randomly allocated to either receive an SMS appointment reminder one day before their scheduled appointment , or to receive no reminder .
RESULTS	No significant differences were found between the SMS and no SMS conditions in relation to appointment attendance .
RESULTS	There were more client dropouts in the SMS compared to the no SMS condition .
CONCLUSIONS	The SMS appointment reminders were not effective at increasing appointment attendance .
CONCLUSIONS	The current research suggests that there is more to client non-attendance in psychological settings than the simple forgetting of appointments .
CONCLUSIONS	Technological adjuncts may be useful in increasing the cost-efficiency of current services ; however , this research highlights the importance of understanding the effects of technology before widespread implementation .

###25010820
BACKGROUND	In this study , our objective was to determine whether a perioperative hemodynamic protocol based on noninvasive cardiac output monitoring decreases the incidence of postoperative complications and hospital length of stay in major abdominal surgery patients requiring intensive care unit admission .
BACKGROUND	Secondary objectives were the time to peristalsis recovery and the incidence of wound infection , anastomotic leaks , and mortality .
METHODS	A randomized clinical trial was conducted in 6 tertiary hospitals .
METHODS	One hundred forty-two adult patients scheduled for open colorectal surgery , gastrectomy , or small bowel resection were enrolled .
METHODS	A hemodynamic protocol including fluid administration and vasoactive drugs based on arterial blood pressure , cardiac index , and stroke volume response was compared with standard practice .
METHODS	Patients were followed until hospital discharge ( determined by a surgeon blinded to the study ) or death .
METHODS	In contrast to previous studies , we designed a pragmatic trial ( as opposed to explanatory trials ) to mimic real practice and obtain maximal external validity for the study .
RESULTS	Fluid administration was similar except for the number of colloid boluses ( 2.4 1.8 [ treated ] vs 1.3 1.4 [ control ] ; P < 0.001 ) and packed red blood cell units ( 0.6 1.3 [ treated ] vs 0.2 0.6 [ control ] ; P = 0.019 ) .
RESULTS	Dobutamine was used in 25 % ( intraoperatively ) and 19.4 % ( postoperatively ) of the treated patients versus 1.4 % and 0 % in the control group ( P < 0.001 ) .
RESULTS	We have observed a reduction in reoperations in the treated group ( 5.6 % vs 15.7 % ; P = 0.049 ) .
RESULTS	However , no significant differences were observed in overall complications ( 40 % vs 41 % ; relative risk 0.99 [ 0.67-1 .44 ] ; P = 0.397 ) , length of stay ( 11.5 [ 8-15 ] vs 10.5 [ 8-16 ] ; P = 0.874 ) , time to first flatus ( 62 hours [ 40-76 ] vs 72 hours [ 48-96 ] ; P = 0.180 ) , wound infection ( 7 vs 14 ; P = 0.085 ) , anastomotic leaks ( 2 vs 5 ; P = 0.23 ) , or mortality ( 4.2 % vs 5.7 % ; P = 0.67 ) .
CONCLUSIONS	The results of our pragmatic study indicate that a perioperative hemodynamic protocol guided by a noninvasive cardiac output monitor was not associated with a decrease in the incidence of overall complications or length of stay in major abdominal surgery .

###25531167
OBJECTIVE	The quality of cardiopulmonary resuscitation ( CPR ) affects hemodynamics , survival , and neurological outcomes following pediatric cardiopulmonary arrest ( CPA ) .
OBJECTIVE	Most health care professionals fail to perform CPR within established American Heart Association guidelines .
OBJECTIVE	To determine whether `` just-in-time '' ( JIT ) CPR training with visual feedback ( VisF ) before CPA or real-time VisF during CPA improves the quality of chest compressions ( CCs ) during simulated CPA .
METHODS	Prospective , randomized , 22 factorial-design trial with explicit methods ( July 1 , 2012 , to April 15 , 2014 ) at 10 International Network for Simulation-Based Pediatric Innovation , Research , & Education ( INSPIRE ) institutions running a standardized simulated CPA scenario , including 324 CPR-certified health care professionals assigned to 3-person resuscitation teams ( 108 teams ) .
METHODS	Each team was randomized to 1 of 4 permutations , including JIT training vs no JIT training before CPA and real-time VisF vs no real-time VisF during simulated CPA .
METHODS	The proportion of CCs with depth exceeding 50 mm , the proportion of CPR time with a CC rate of 100 to 120 per minute , and CC fraction ( percentage CPR time ) during simulated CPA .
RESULTS	The quality of CPR was poor in the control group , with 12.7 % ( 95 % CI , 5.2 % -20.1 % ) mean depth compliance and 27.1 % ( 95 % CI , 14.2 % -40.1 % ) mean rate compliance .
RESULTS	JIT training compared with no JIT training improved depth compliance by 19.9 % ( 95 % CI , 11.1 % -28.7 % ; P < .001 ) and rate compliance by 12.0 % ( 95 % CI , 0.8 % -23.2 % ; P = .037 ) .
RESULTS	Visual feedback compared with no VisF improved depth compliance by 15.4 % ( 95 % CI , 6.6 % -24.2 % ; P = .001 ) and rate compliance by 40.1 % ( 95 % CI , 28.8 % -51.3 % ; P < .001 ) .
RESULTS	Neither intervention had a statistically significant effect on CC fraction , which was excellent ( > 89.0 % ) in all groups .
RESULTS	Combining both interventions showed the highest compliance with American Heart Association guidelines but was not significantly better than either intervention in isolation .
CONCLUSIONS	The quality of CPR provided by health care professionals is poor .
CONCLUSIONS	Using novel and practical technology , JIT training before CPA or real-time VisF during CPA , alone or in combination , improves compliance with American Heart Association guidelines for CPR that are associated with better outcomes .
BACKGROUND	clinicaltrials.gov Identifier : NCT02075450 .

###24621064
OBJECTIVE	Multiple sclerosis ( MS ) is an immune-mediated neurodegenerative disease of central nervous system and recent studies show that inflammatory processes are highly associated with neurodegeneration in the brain .
OBJECTIVE	The purpose of this study was to investigate the effect of coenzyme Q10 supplementation on inflammatory and anti-inflammatory markers in patients with MS.
METHODS	This randomized , double-blind , placebo-controlled clinical study was performed among 48 patients with relapsing-remitting MS. Subjects were randomly assigned to a placebo group ( n = 24 ) or coenzyme Q10 ( CoQ10 ) - supplemented group ( 500 mg/day , n = 24 ) .
METHODS	The intervention was administered for 12 weeks .
METHODS	Peripheral blood samples were collected at baseline and after 12-week intervention , to measure inflammatory ( tumor necrosis factor - ( TNF - ) , interleukin ( IL ) -6 , and matrix metalloproteinase ( MMP ) -9 ) and anti-inflammatory ( IL-4 and TGF - ) markers .
RESULTS	Forty-five patients completed the study .
RESULTS	After 12 weeks of intervention , the TNF - levels ( P = 0.003 ) decreased significantly in the CoQ10 group .
RESULTS	Subjects in the CoQ10 group had significantly lower IL-6 levels ( P = 0.037 ) , compared to the placebo group .
RESULTS	CoQ10 supplementation also resulted in decreased serum levels of MMP-9 as compared to the placebo group ( P = 0.011 ) .
RESULTS	However , CoQ10 supplementation did not alter the IL-4 and TGF - levels ( P = 0.16 and P = 0.81 , respectively ) .
CONCLUSIONS	CoQ10 supplementation at a dosage of 500 mg appears to decrease the inflammatory markers ( TNF - , IL-6 , and MMP-9 ) in patients with MS.

###24978674
OBJECTIVE	The objective of the study was to assess the effect of T treatment on constitutional and sexual symptoms in men with type 2 diabetes ( T2D ) .
METHODS	This was a randomized double-blind , parallel , placebo-controlled trial .
METHODS	The study was conducted at a tertiary referral center .
METHODS	Men aged 35-70 years with T2D , a hemoglobin A1c less than 8.5 % , and a total T level less than 12.0 nmol/L ( 346 ng/dL ) with mild to moderate aging male symptoms and erectile dysfunction .
METHODS	Eighty-eight participants were randomly assigned to 40 weeks of im T undecanoate ( n = 45 ) or matching placebo ( n = 43 ) .
METHODS	Constitutional symptoms using the aging male symptoms ( AMS ) score , sexual desire ( question 17 AMS score ) , and erectile function ( International Index of Erectile Function-5 ) .
RESULTS	T treatment did not substantially improve aging male symptoms [ mean adjusted difference ( MAD ) in change over 40 weeks across the T and placebo groups in AMS total score , -0.9 ( 95 % confidence interval [ CI ] -4.1 , 2.2 ) , P = .67 ] or sexual desire [ MAD in question 17 AMS , -0.3 ( 95 % CI -0.8 , 0.2 ) , P = .17 ] .
RESULTS	Although compared with placebo , erectile function in men assigned to T was reduced [ MAD in International Index of Erectile Function abridged version 5 , -2.0 ( 95 % CI -3.4 , -0.6 ) , P < .02 ] , there was no significant difference between baseline and 40-week International Index of Erectile Function abridged version 5 scores if both groups were analyzed separately .
RESULTS	At baseline , symptoms were worse in men with depression and microvascular complications but did not correlate with T levels .
CONCLUSIONS	In this trial , T treatment did not substantially improve constitutional or sexual symptoms in obese , aging men with T2D with mild to moderate symptoms and modest reduction in T levels typical for the vast majority of such men .

###24276102
BACKGROUND	According to the findings of some studies , instability due to inertia during changes in speed may negatively impact the quality of chest compressions performed during cardiopulmonary resuscitation ( CPR ) in a moving environment .
BACKGROUND	This study thus aimed to introduce a simple device that maintains the balance of a person performing CPR in a moving environment , such as an ambulance .
BACKGROUND	We also sought to evaluate the effectiveness of this device in the improvement of the quality of chest compressions .
METHODS	The experiment comprised a total of 40 simulated cardiopulmonary arrest scenes ( 20 in the experimental group and 20 in the control ) , in which CPR was conducted by eight paramedics .
METHODS	Each simulation involved two paramedics randomly selected from the eight .
METHODS	The ambulance took the same route from the simulated site to the hospital , and continuous CPR was performed on a manikin in the ambulance with or without the aid of our proposed novel device .
RESULTS	The average number of chest compressions per simulation in the experimental and control groups was 1330.75 and 1266.60 , respectively ( p = 0.095 ) .
RESULTS	The percentage of chest compressions with adequate depth achieved in the experimental and control groups was 72 % 4 % and 50 % 3 % , respectively ( p < 0.0001 ) .
CONCLUSIONS	By maintaining the balance of the CPR performer , our proposed novel device can offset the negative impact that instability ( due to a moving environment ) has on chest compressions .
CONCLUSIONS	The device may also lead to an increase in the percentage of chest compressions that achieve adequate depth .

###24460405
BACKGROUND	This pilot study examined , whether long-term exposure of psychiatric patients to music that was individually adapted to brain rhythm disorders associated with psychoticism could act to ameliorate psychiatric symptoms .
METHODS	A total of 50 patients with various psychiatric diagnoses were randomised in a 1:1 ratio to listen to CDs containing either music adapted to brain rhythm anomalies associated with psychoticism - measured via a specific spectral analysis - or standard classical music .
METHODS	Participants were instructed to listen to the CDs over the next 18 months .
METHODS	Psychiatric symptoms in both groups were assessed at baseline and at 4 , 8 and 18 months , using the Brief Symptom Inventory ( BSI ) .
RESULTS	At 18 months , patients in the experimental group showed significantly decreased BSI scores compared to control patients .
RESULTS	Intriguingly , this effect was not only seen for symptoms of psychoticism and paranoia but also for anxiety , phobic anxiety and somatisation .
CONCLUSIONS	Exposure to the adapted music was effective in ameliorating psychotic , anxiety and phobic anxiety symptoms .
CONCLUSIONS	Based on the theories of neuroplasticity and brain rhythms , it can be hypothesised that this intervention may be enhancing brain-rhythm synchronisation and plasticity in prefrontal-hippocampal circuits that are implicated in both psychosis/paranoia and anxiety/phobic anxiety .

###25833885
BACKGROUND	High US sodium intake and national reduction efforts necessitate developing a feasible and valid monitoring method across the distribution of low-to-high sodium intake .
OBJECTIVE	We examined a statistical approach using timed urine voids to estimate the population distribution of usual 24-h sodium excretion .
METHODS	A sample of 407 adults , aged 18-39 y ( 54 % female , 48 % black ) , collected each void in a separate container for 24 h ; 133 repeated the procedure 4-11 d later .
METHODS	Four timed voids ( morning , afternoon , evening , overnight ) were selected from each 24-h collection .
METHODS	We developed gender-specific equations to calibrate total sodium excreted in each of the one-void ( e.g. , morning ) and combined two-void ( e.g. , morning + afternoon ) urines to 24-h sodium excretion .
METHODS	The calibrated sodium excretions were used to estimate the population distribution of usual 24-h sodium excretion .
METHODS	Participants were then randomly assigned to modeling ( n = 160 ) or validation ( n = 247 ) groups to examine the bias in estimated population percentiles .
RESULTS	Median bias in predicting selected percentiles ( 5th , 25th , 50th , 75th , 95th ) of usual 24-h sodium excretion with one-void urines ranged from -367 to 284 mg ( -7.7 to 12.2 % of the observed usual excretions ) for men and -604 to 486 mg ( -14.6 to 23.7 % ) for women , and with two-void urines from -338 to 263 mg ( -6.9 to 10.4 % ) and -166 to 153 mg ( -4.1 to 8.1 % ) , respectively .
RESULTS	Four of the 6 two-void urine combinations produced no significant bias in predicting selected percentiles .
CONCLUSIONS	Our approach to estimate the population usual 24-h sodium excretion , which uses calibrated timed-void sodium to account for day-to-day variation and covariance between measurement errors , produced percentile estimates with relatively low biases across low-to-high sodium excretions .
CONCLUSIONS	This may provide a low-burden , low-cost alternative to 24-h collections in monitoring population sodium intake among healthy young adults and merits further investigation in other population subgroups .

###25428341
OBJECTIVE	To observe the clinical curative effect of Chinese medicine Bushen Huoxue Granule ( , BHG ) on Parkinson 's disease ( PD ) patients with depressive state .
METHODS	Sixty-two PD patients with depressive state were randomly assigned to two groups by using a random number table , 31 in each group .
METHODS	Madopar was given to all as the conventional treatment .
METHODS	The fluoxetine hydrochloride dispersible tablet was given to the patients in the control group and BHG was given to those in the treatment group .
METHODS	The therapeutic course for all was 12 weeks .
METHODS	Before and after treatment , Hamilton depression rating scale ( HAMD ) was applied to judge the curative effect , and the changes of cerebral neurotransmitters levels in the brain of patients were detected by encephalofluctuograph technique .
RESULTS	The scores of HAMD in the two groups were decreased markedly after 12-week treatment .
RESULTS	It was lower in the treatment group than that in the control group with significant difference ( P < 0.01 ) .
RESULTS	The contents of norepinephrine ( NE ) and 5-serotonin ( 5-HT ) in the PD patients were obviously lower than normal value .
RESULTS	There was no significant difference between the two groups before treatment ( P > 0.05 ) .
RESULTS	The contents of NE and 5-HT were all increased in the two groups after treatment ( P < 0.05 ) , with significant differences between the two groups ( P < 0.01 ) .
CONCLUSIONS	BHG could increase the contents of NE and 5-HT in PD patients ' brain to improve the depressive state of PD patients .

###25123219
OBJECTIVE	The optimum model of physiotherapy service delivery for maximizing active task practice during rehabilitation after stroke is unknown .
OBJECTIVE	The purpose of the study was to examine the relative effectiveness of 2 alternative models of physiotherapy service delivery against a usual care control with regard to increasing patient activity .
METHODS	Substudy within a large 3-armed randomized controlled trial , which compared 3 different models of physiotherapy service delivery , was provided for 4 weeks during subacute , inpatient rehabilitation ( n = 283 ) .
METHODS	The duration of all physiotherapy sessions was recorded .
METHODS	In addition , 32 participants were observed at 10-minute intervals for 1 weekday and 1 weekend day between 8:00 am and 4:30 pm .
METHODS	At each observation , we recorded physical activity , location , and people present .
RESULTS	Participants receiving 7-day-week and circuit class therapy received an additional 3 hours and 22 hours of physiotherapy time , respectively , when compared with usual care .
RESULTS	Participants were standing or walking for a median of 8.2 % of observations .
RESULTS	On weekdays , circuit class therapy participants spent more time in therapy-related activity ( 10.2 % of observations ) when compared with usual care participants ( 6.1 % of observations ) .
RESULTS	On weekends , 7-day therapy participants spent more time in therapy-related activity ( 4.2 % of observations ) when compared with both usual care and circuit class therapy participants ( 0 % of observations for both groups ) .
RESULTS	Activity levels outside of therapy sessions did not differ between groups .
CONCLUSIONS	A greater dosage of physiotherapy time did not translate into meaningful increases in physical activity across the day .
BACKGROUND	http://www.anzctr.org.au/ .
BACKGROUND	Unique identifier : ACTRN12610000096055 .

###25430687
OBJECTIVE	Repetitive transcranial magnetic stimulation ( rTMS ) of the left dorsolateral-prefrontal cortex ( DLPFC ) exerts antidepressant effects .
OBJECTIVE	In this randomised controlled clinical trial we aimed to test the safety and therapeutic efficacy of bilateral theta-burst stimulation ( TBS ) as an add-on therapy to standard treatment of major depression .
METHODS	Fifty-six patients diagnosed with a moderate to severe depressive episode received 15 daily treatments of either rTMS ( 110 % motor-threshold ; rightDLPFC , 1000 stimuli at 1 Hz + leftDLPFC , 1000 stimuli at 10 Hz ) , theta-burst stimulation ( 80 % motor-threshold ; rightDLPFC , continuous TBS , 1200 stimuli + leftDLPFC , intermittent TBS , 1200 stimuli ) , or sham TMS ( N = 17 , sham coil with the TBS protocol ) .
RESULTS	There was no significant effect in the primary outcome measures ( change of the 21-item Hamilton Rating Scale for Depression ) .
RESULTS	However , there was a tendency towards an increased responder rate at the end of the follow-up period for both active treatments as compared to sham , and this tendency was most pronounced for the TBS group .
CONCLUSIONS	This pilot study did not reveal significant advantages of bilateral TBS or rTMS over sham treatment as an add-on treatment for major depression .
CONCLUSIONS	A tendency towards a superior effect of bilateral TBS at the end of the follow-up period may warrant further studies .

###24499492
OBJECTIVE	This study aimed to assess the dose and volume effects of suppository preparations and safety of NRL001 ( one of four possible stereoisomers of methoxamine hydrochloride ) on anal sphincter tone using rectal suppositories in healthy adult volunteers .
METHODS	This was a Phase I , single-centre , randomised , double-blind , three-way crossover study during which subjects received three single doses of 1 g rectal suppositories ( containing 5 or 10 mg NRL001 or matching placebo ) or 2 g rectal suppositories ( containing 10 or 15 mg NRL001 or matching placebo ) on three separate dosing days .
METHODS	The outcome measures were mean anal resting pressure ( MARP ) variables ( monitored continuously for 20-30 min before and up to 6 h after dosing ) , pharmacokinetics ( PK ) and safety assessments .
RESULTS	Twenty-six subjects were dosed with study medication .
RESULTS	Two subjects were withdrawn prematurely and were not included in the main analysis .
RESULTS	There was a dose-dependent increase in anal sphincter tone ( MARP ) when comparing the 5 and 10 mg doses of NRL001 ; however , the 15 mg dose did not have a significantly greater effect than the 10 mg dose .
RESULTS	Suppository size ( 1 or 2 g ) did not appear to have an effect on sphincter tone .
RESULTS	There was no evidence against dose proportionality for the PK variables , but the mean maximum plasma concentration ( Cmax ) for the 1 g suppository group was higher than for the 2 g group .
RESULTS	Twenty-one adverse events were reported in 8 ( 30.8 % ) subjects .
RESULTS	A dose dependent decrease in heart rate was noted ; however , there were no adverse events reported that were related to this reduction in heart rate .
CONCLUSIONS	The increase in anal sphincter tone supports the potential therapeutic use of NRL001 in treating faecal incontinence , with further studies in patients required .
CONCLUSIONS	NRL001 was well tolerated in single doses of up to 15 mg .

###24733277
OBJECTIVE	Depression and anxiety are associated with adverse cardiovascular outcomes in patients with recent acute cardiac events .
OBJECTIVE	There has been minimal study of collaborative care ( CC ) management models for mental health disorders in high-risk cardiac inpatients , and no prior CC intervention has simultaneously managed depression and anxiety disorders .
OBJECTIVE	To determine the impact of a low-intensity CC intervention for depression , generalized anxiety disorder , and panic disorder among patients hospitalized for an acute cardiac illness .
METHODS	Single-blind randomized clinical trial , with study assessors blind to group assignment , from September 2010 through July 2013 of 183 patients admitted to inpatient cardiac units in an urban academic general hospital for acute coronary syndrome , arrhythmia , or heart failure and found to have clinical depression , generalized anxiety disorder , or panic disorder on structured assessment .
METHODS	Participants were randomized to 24 weeks of a low-intensity telephone-based multicomponent CC intervention targeting depression and anxiety disorders ( n = 92 ) or to enhanced usual care ( serial notification of primary medical providers ; n = 91 ) .
METHODS	The CC intervention used a social work care manager to coordinate assessment and stepped care of psychiatric conditions and to provide support and therapeutic interventions as appropriate .
METHODS	Improvement in mental health-related quality of life ( Short Form-12 Mental Component Score [ SF-12 MCS ] ) at 24 weeks , compared between groups using a random-effects model in an intent-to-treat analysis .
RESULTS	Patients randomized to CC had significantly greater estimated mean improvements in SF-12 MCS at 24 weeks ( 11.21 points [ from 34.21 to 45.42 ] in the CC group vs 5.53 points [ from 36.30 to 41.83 ] in the control group ; estimated mean difference , 5.68 points [ 95 % CI , 2.14-9 .22 ] ; P = .002 ; effect size , 0.61 ) .
RESULTS	Patients receiving CC also had significant improvements in depressive symptoms and general functioning , and higher rates of treatment of a mental health disorder ; anxiety scores , rates of disorder response , and adherence did not differ between groups .
CONCLUSIONS	A novel telephone-based , low-intensity model to concurrently manage cardiac patients with depression and/or anxiety disorders was effective for improving mental health-related quality of life in a 24-week trial .
BACKGROUND	clinicaltrials.gov Identifier : NCT01201967 .

###24656524
BACKGROUND	There are conflicting results on the impact of anxiety on depression outcomes .
BACKGROUND	The impact of anxiety has not been studied in major depression with psychotic features ( `` psychotic depression '' ) .
OBJECTIVE	We assessed the impact of specific anxiety symptoms and disorders on the outcomes of psychotic depression .
METHODS	We analyzed data from the Study of Pharmacotherapy for Psychotic Depression that randomized 259 younger and older participants to either olanzapine plus placebo or olanzapine plus sertraline .
METHODS	We assessed the impact of specific anxiety symptoms from the Brief Psychiatric Rating Scale ( `` tension '' , `` anxiety '' and `` somatic concerns '' and a composite anxiety score ) and diagnoses ( panic disorder and GAD ) on psychotic depression outcomes using linear or logistic regression .
METHODS	Age , gender , education and benzodiazepine use ( at baseline and end ) were included as covariates .
RESULTS	Anxiety symptoms at baseline and anxiety disorder diagnoses differentially impacted outcomes .
RESULTS	On adjusted linear regression there was an association between improvement in depressive symptoms and both baseline `` tension '' ( coefficient = 0.784 ; 95 % CI : 0.169-1 .400 ; p = 0.013 ) and the composite anxiety score ( regression coefficient = 0.348 ; 95 % CI : 0.064-0 .632 ; p = 0.017 ) .
RESULTS	There was an interaction between `` tension '' and treatment group , with better responses in those randomized to combination treatment if they had high baseline anxiety scores ( coefficient = 1.309 ; 95 % CI : 0.105-2 .514 ; p = 0.033 ) .
RESULTS	In contrast , panic disorder was associated with worse clinical outcomes ( coefficient = -3.858 ; 95 % CI : -7.281 to -0.434 ; p = 0.027 ) regardless of treatment .
CONCLUSIONS	Our results suggest that analysis of the impact of anxiety on depression outcome needs to differentiate psychic and somatic symptoms .

###24916953
OBJECTIVE	To evaluate the feasibility and appropriateness of a prehospital system allowing ambulance nurses to transport older adults directly to geriatric care at a community-based hospital ( CH ) or to an emergency department ( ED ) .
METHODS	Randomized controlled trial .
METHODS	Emergency medical services in Stockholm , Sweden .
METHODS	Older adults who called the emergency number were randomized to an intervention group ( n = 410 ) or a control group ( n = 396 ) .
METHODS	The dispatcher randomized the individuals .
METHODS	Those randomized to the intervention group were transported to several alternative destinations decided by a trained nurse performing a comprehensive assessment , using the new prehospital system .
METHODS	Those randomized to the control group were transported to the ED .
METHODS	Primary endpoint : number of individuals triaged directly to a CH ( feasibility ) .
METHODS	Secondary endpoint : number of subsequent transfers ( appropriateness ) from CH to ED within 24 hours after initial admission .
RESULTS	After exclusion and crossover , the control group consisted of 217 and the intervention group of 449 older adults .
RESULTS	The nurse sent 20 % of the intervention group ( 90/449 ) ( 95 % confidence interval ( CI ) = 16.6-24 .0 ) directly to the CH when using the prehospital system .
RESULTS	Six of those individuals ( 6.7 % ) ( 95 % CI = 3.1-13 .8 ) were subsequently transferred from the CH to the ED .
RESULTS	Overall , the nurse appropriately triaged 93.3 % of the participants ( 84/90 ) and transferred them to the CH , avoiding an ED visit .
CONCLUSIONS	Ambulance nurses are able to send older adults to an alternative healthcare facility with the help of a prehospital decision support system .
CONCLUSIONS	In this geographical setting , this appears to be a promising method to optimize resources and improve emergency care of elderly adults .

###24533082
BACKGROUND	The culture in many team sports involves consumption of large amounts of alcohol after training/competition .
BACKGROUND	The effect of such a practice on recovery processes underlying protein turnover in human skeletal muscle are unknown .
BACKGROUND	We determined the effect of alcohol intake on rates of myofibrillar protein synthesis ( MPS ) following strenuous exercise with carbohydrate ( CHO ) or protein ingestion .
METHODS	In a randomized cross-over design , 8 physically active males completed three experimental trials comprising resistance exercise ( 85 reps leg extension , 80 % 1 repetition maximum ) followed by continuous ( 30 min , 63 % peak power output ( PPO ) ) and high intensity interval ( 1030 s , 110 % PPO ) cycling .
METHODS	Immediately , and 4 h post-exercise , subjects consumed either 500 mL of whey protein ( 25 g ; PRO ) , alcohol ( 1.5 gkg body mass ) , 122 standard drinks ) co-ingested with protein ( ALC-PRO ) , or an energy-matched quantity of carbohydrate also with alcohol ( 25 g maltodextrin ; ALC-CHO ) .
METHODS	Subjects also consumed a CHO meal ( 1.5 g CHOkg body mass ) 2 h post-exercise .
METHODS	Muscle biopsies were taken at rest , 2 and 8 h post-exercise .
RESULTS	Blood alcohol concentration was elevated above baseline with ALC-CHO and ALC-PRO throughout recovery ( P < 0.05 ) .
RESULTS	Phosphorylation of mTOR ( Ser2448 ) 2 h after exercise was higher with PRO compared to ALC-PRO and ALC-CHO ( P < 0.05 ) , while p70S6K phosphorylation was higher 2 h post-exercise with ALC-PRO and PRO compared to ALC-CHO ( P < 0.05 ) .
RESULTS	Rates of MPS increased above rest for all conditions ( 29-109 % , P < 0.05 ) .
RESULTS	However , compared to PRO , there was a hierarchical reduction in MPS with ALC-PRO ( 24 % , P < 0.05 ) and with ALC-CHO ( 37 % , P < 0.05 ) .
CONCLUSIONS	We provide novel data demonstrating that alcohol consumption reduces rates of MPS following a bout of concurrent exercise , even when co-ingested with protein .
CONCLUSIONS	We conclude that alcohol ingestion suppresses the anabolic response in skeletal muscle and may therefore impair recovery and adaptation to training and/or subsequent performance .

###24866329
OBJECTIVE	Postprandial hyperglycemia and blood glucose fluctuations increase the risk of macroangiopathy in patients with type 2 diabetes mellitus ( T2DM ) .
OBJECTIVE	However , few studies have examined the effects of oral hypoglycemic drugs on blood glucose fluctuations in daily life .
METHODS	Twenty-nine T2DM patients treated with acarbose were randomized to receive either sitagliptin ( 14 patients ) or mitiglinide ( 15 patients ) together with acarbose for 4 weeks .
METHODS	Patients were then switched to a combination of 10 mg mitiglinide and 0.2 mg voglibose for 4 weeks .
METHODS	All patients wore a continuous glucose monitoring ( CGM ) device for 5 - 7 days in week 3 of each treatment period .
RESULTS	The percentage of blood glucose levels in the hyperglycemic range , blood glucose indices derived from 24-h CGM profiles and the glycemic parameters ( HbA1c , glycated albumin and fasting plasma glucose ) were significantly improved by adding sitagliptin or mitiglinide to ongoing acarbose therapy .
RESULTS	These parameters also tended to improve in the mitiglinide/voglibose combination period .
CONCLUSIONS	Daily blood glucose fluctuations were significantly improved by adding sitagliptin or mitiglinide to acarbose , and improved after switching to the mitiglinide/voglibose combination .
CONCLUSIONS	Larger controlled studies are needed to verify the effects of adding sitagliptin or mitiglinide to acarbose on glucose fluctuations .

###25146061
BACKGROUND	Premenstrual syndrome ( PMS ) may have negative effects on women 's health and sometimes need therapeutic non-pharmacological management .
OBJECTIVE	To determine the effect of oral consumption of 1000 mg Royal Jelly capsule on premenstrual syndrome .
METHODS	This is a randomized , triple-blind , placebo-controlled clinical trial , which was conducted in Tehran University of Medical Sciences female dormitories between December 2011 and October 2012 .
METHODS	The study population comprised 110 medical sciences student with PMS , whom were randomly assigned to an intervention or a control group .
METHODS	Each participant in the intervention group took one Royal jelly capsule orally per day , starting on the first day of menstruation and continued the same treatment daily throughout two consecutive menstrual cycles , while participants in the intervention group took placebo capsules as same method .
METHODS	The outcome measure in this study was PMS score as obtained through the Premenstrual Profile 2005 .
RESULTS	The mean of personal characteristics and baseline level of the premenstrual score before intervention did not differ between groups .
RESULTS	After two consecutive months consumption of Royal Jelly , PMS score had decreased from 23.17 17.43 to 11.42 14.58 ( mean change : 11.75 ; 95 % confidence interval [ CI ] : 8.31-15 .19 ) and in Placebo , PMS score changed from 21.48 16.39 to 20.27 15.76 ( mean change : 1.20 ; 95 % CI : -1.69 to 4.10 ) .
RESULTS	Also difference between mean changes was significant ( mean difference : 10.54 ; 95 % CI : 6.10-14 .98 ) .
CONCLUSIONS	The results of the study have demonstrated that 2 months consumption of Royal Jelly was effective in reducing PMS .

###24445180
OBJECTIVE	An earlier randomized controlled trial found that two middle school sexual education programs-a risk avoidance ( RA ) program and a risk reduction ( RR ) program-delayed initiation of sexual intercourse ( oral , vaginal , or anal sex ) and reduced other sexual risk behaviors in ninth grade .
OBJECTIVE	We examined whether these effects extended into 10th grade .
METHODS	Fifteen middle schools were randomly assigned to RA , RR , or control conditions .
METHODS	Follow-up surveys were conducted with participating students in 10th grade ( n = 1,187 ; 29.2 % attrition ) .
RESULTS	Participants were 60 % female , 50 % Hispanic , and 39 % black ; seventh grade mean age was 12.6 years .
RESULTS	In 10th grade , compared with the control condition , both programs significantly delayed anal sex initiation in the total sample ( RA : adjusted odds ratio [ AOR ] , .64 , 95 % confidence interval [ CI ] , .42 -.99 ; RR : AOR , .65 , 95 % CI , .50 -.84 ) and among Hispanics ( RA : AOR , .53 , 95 % CI , .31 -.91 ; RR : AOR , .82 , 95 % CI , .74 -.93 ) .
RESULTS	Risk avoidance students were less likely to report unprotected vaginal sex , either by using a condom or by abstaining from sex ( AOR : .61 , 95 % CI , .45 -.85 ) ; RR students were less likely to report recent unprotected anal sex ( AOR : .34 , 95 % CI , .20 -.56 ) .
RESULTS	Both programs sustained positive impact on some psychosocial outcomes .
CONCLUSIONS	Although both programs delayed anal sex initiation into 10th grade , effects on the delayed initiation of oral and vaginal sex were not sustained .
CONCLUSIONS	Additional high school sexual education may help to further delay sexual initiation and reduce other sexual risk behaviors in later high school years .

###24808487
BACKGROUND	Lutein accumulates in the macula and brain , where it is assumed to play physiologic roles .
BACKGROUND	The bioavailability of lutein is assumed to display a high interindividual variability that has been hypothesized to be attributable , at least partly , to genetic polymorphisms .
OBJECTIVE	We characterized the interindividual variability in lutein bioavailability in humans , assessed the relation between this variability and the fasting blood lutein concentration , and identified single nucleotide polymorphisms ( SNPs ) involved in this phenomenon .
METHODS	In a randomized , 2-way crossover study , 39 healthy men consumed a meal that contained a lutein supplement or the same meal for which lutein was provided through a tomato puree .
METHODS	The lutein concentration was measured in plasma chylomicrons isolated at regular time intervals over 8 h postprandially .
METHODS	Multivariate statistical analyses were used to identify a combination of SNPs associated with the postprandial chylomicron lutein response ( 0-8-h area under the curve ) .
METHODS	A total of 1785 SNPs in 51 candidate genes were selected .
RESULTS	Postprandial chylomicron lutein responses to meals were very variable ( CV of 75 % and 137 % for the lutein-supplement meal and the meal with tomato-sourced lutein , respectively ) .
RESULTS	Postprandial chylomicron lutein responses measured after the 2 meals were positively correlated ( r = 0.68 , P < 0.0001 ) and positively correlated to the fasting plasma lutein concentration ( r = 0.51 , P < 0.005 for the lutein-supplement-containing meal ) .
RESULTS	A significant ( P = 1.9 10 ( -4 ) ) and validated partial least-squares regression model , which included 29 SNPs in 15 genes , explained most of the variance in the postprandial chylomicron lutein response .
CONCLUSIONS	The ability to respond to lutein appears to be , at least in part , genetically determined .
CONCLUSIONS	The ability is explained , in large part , by a combination of SNPs in 15 genes related to both lutein and chylomicron metabolism .
CONCLUSIONS	Finally , our results suggest that the ability to respond to lutein and blood lutein status are related .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT02100774 .

###25343848
BACKGROUND	Mindfulness interventions to reduce psychological distress are well-suited to pregnancy , due to their brief and non-pharmacological nature , but there is a need for more robust evidence determining their usefulness .
BACKGROUND	This pilot study was designed to explore the feasibility of a randomised controlled trial of a mindfulness intervention to reduce antenatal depression , anxiety and stress .
METHODS	The study was designed in two parts 1 ) a non-randomised trial targeting women at risk of mental health problems ( a selected population ) and 2 ) a randomised controlled trial ( RCT ) of a universal population .
METHODS	Process evaluation focused on feasibility of recruitment pathways , participant retention , acceptability of study measures , and engagement with mindfulness practices .
METHODS	Measurement of psychological distress was taken pre and post intervention through the Centre for Epidemiologic Studies Depression Scale Revised , the Depression Anxiety and Stress Scale-21 , the State-Trait Anxiety Inventory , and the Perceived Stress Scale .
RESULTS	20 women were recruited to the non-randomised trial , and 32 to the RCT .
RESULTS	Recruitment through a mailed study brochure at the time of booking-in to the hospital resulted in the largest number of participants in the RCT ( 16/32 ; 50 % ) , and resulted in considerably earlier recruitment ( 50 % in first trimester , 50 % second trimester ) compared to recruitment through the antenatal clinic waiting room ( 86 % in second trimester , 14 % third trimester ) .
RESULTS	Over a third of women in the universal population scored above clinical cut-offs for depression and anxiety , indicating a sample with more symptomology than the general population .
RESULTS	The most common reason for loss to follow-up was delivery of baby prior to follow-up ( n = 9 ) .
RESULTS	In the non-randomised study , significant within group improvements to depression and anxiety were observed .
RESULTS	In the intervention arm of the RCT there were significant within group improvements to anxiety and mindfulness .
RESULTS	No between group differences for the intervention and ` care as usual ' control group were observed .
CONCLUSIONS	This small pilot study provides evidence on the feasibility of an antenatal mindfulness intervention to reduce psychological distress .
CONCLUSIONS	Major challenges include : finding ways to facilitate recruitment in early pregnancy and engaging younger women and other vulnerable populations .
BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12613000742774 ( 31/10/2012 ) .

###26010418
OBJECTIVE	Prevention of iron deficiency in infancy may promote neurodevelopment .
OBJECTIVE	Delayed umbilical cord clamping ( CC ) prevents iron deficiency at 4 to 6 months of age , but long-term effects after 12 months of age have not been reported .
OBJECTIVE	To investigate the effects of delayed CC compared with early CC on neurodevelopment at 4 years of age .
METHODS	Follow-up of a randomized clinical trial conducted from April 16 , 2008 , through May 21 , 2010 , at a Swedish county hospital .
METHODS	Children who were included in the original study ( n = 382 ) as full-term infants born after a low-risk pregnancy were invited to return for follow-up at 4 years of age .
METHODS	Wechsler Preschool and Primary Scale of Intelligence ( WPPSI-III ) and Movement Assessment Battery for Children ( Movement ABC ) scores ( collected between April 18 , 2012 , and July 5 , 2013 ) were assessed by a blinded psychologist .
METHODS	Between April 11 , 2012 , and August 13 , 2013 , parents recorded their child 's development using the Ages and Stages Questionnaire , Third Edition ( ASQ ) and behavior using the Strengths and Difficulties Questionnaire .
METHODS	All data were analyzed by intention to treat .
METHODS	Randomization to delayed CC ( 180 seconds after delivery ) or early CC ( 10 seconds after delivery ) .
METHODS	The main outcome was full-scale IQ as assessed by the WPPSI-III .
METHODS	Secondary objectives were development as assessed by the scales from the WPPSI-III and Movement ABC , development as recorded using the ASQ , and behavior using the Strengths and Difficulties Questionnaire .
RESULTS	We assessed 263 children ( 68.8 % ) .
RESULTS	No differences were found in WPPSI-III scores between groups .
RESULTS	Delayed CC improved the adjusted mean differences ( AMDs ) in the ASQ personal-social ( AMD , 2.8 ; 95 % CI , 0.8-4 .7 ) and fine-motor ( AMD , 2.1 ; 95 % CI , 0.2-4 .0 ) domains and the Strengths and Difficulties Questionnaire prosocial subscale ( AMD , 0.5 ; 95 % CI , > 0.0-0 .9 ) .
RESULTS	Fewer children in the delayed-CC group had results below the cutoff in the ASQ fine-motor domain ( 11.0 % vs 3.7 % ; P = .02 ) and the Movement ABC bicycle-trail task ( 12.9 % vs 3.8 % ; P = .02 ) .
RESULTS	Boys who received delayed CC had significantly higher AMDs in the WPPSI-III processing-speed quotient ( AMD , 4.2 ; 95 % CI , 0.8-7 .6 ; P = .02 ) , Movement ABC bicycle-trail task ( AMD , 0.8 ; 95 % CI , 0.1-1 .5 ; P = .03 ) , and fine-motor ( AMD , 4.7 ; 95 % CI , 1.0-8 .4 ; P = .01 ) and personal-social ( AMD , 4.9 ; 95 % CI , 1.6-8 .3 ; P = .004 ) domains of the ASQ .
CONCLUSIONS	Delayed CC compared with early CC improved scores in the fine-motor and social domains at 4 years of age , especially in boys , indicating that optimizing the time to CC may affect neurodevelopment in a low-risk population of children born in a high-income country .
BACKGROUND	clinicaltrials.gov Identifier : NCT01581489 .

###24525954
OBJECTIVE	The Alberta Stroke Program Early CT Score ( ASPECTS ) on baseline imaging is an established predictor of acute ischemic stroke outcomes .
OBJECTIVE	We analyzed change on serial ASPECTS at baseline and 24-hour imaging in the Solitaire Flow Restoration with the Intention for Thrombectomy ( SWIFT ) study to determine prognostic value and to identify subgroups with extensive injury after intervention .
METHODS	ASPECTS at baseline and 24 hours was independently scored in all anterior circulation SWIFT cases , blinded to all other trial data .
METHODS	ASPECTS at baseline , at 24 hours , and serial changes were analyzed with univariate and multivariate approaches .
RESULTS	One hundred thirty-nine patients ( mean age , 67 [ SD , 12 ] years ; 52 % women ; median National Institutes of Health Stroke Scale , 18 [ interquartile range , 8-28 ] ) with complete data at both time points were studied .
RESULTS	Multivariate analyses showed that higher 24-hour ASPECTS predicted good clinical outcome ( day 90 modified Rankin Scale , 0-2 ; odds ratio , 1.67 ; P < 0.001 ) .
RESULTS	Among patients with high baseline ASPECTS ( 8-10 ; n = 109 ) , dramatic infarct progression ( decrease in ASPECTS 6 points at 24 hours ) was noted in 31 of 109 ( 28 % ) .
RESULTS	Such serial ASPECTS change was predicted by higher baseline systolic blood pressure ( P = 0.019 ) , higher baseline blood glucose ( P = 0.133 ) , and failure to achieve Thrombolysis in Cerebral Infarction score of 2b/3 reperfusion ( P < 0.001 ) , culminating in worse day 90 modified Rankin Scale outcomes ( mean modified Rankin Scale , 4.4 versus 2.7 ; P < 0.001 ) .
CONCLUSIONS	Twenty-four-hour ASPECTS provides better prognostic information compared with baseline ASPECTS .
CONCLUSIONS	Predictors of dramatic infarct progression on ASPECTS are hyperglycemia , hypertension , and nonreperfusion .
CONCLUSIONS	Serial ASPECTS change from baseline to 24 hours predicts clinical outcome , providing an early surrogate end point for thrombectomy trials .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01054560 .

###25372920
OBJECTIVE	We tested the hypothesis that direct intramyocardial injection of bone marrow mononuclear cells in patients with non-ischemic dilated cardiomyopathy can improve left ventricular function and physical capacity .
METHODS	Thirty non-ischemic dilated cardiomyopathy patients with left ventricular ejection fraction < 35 % were randomized at a 1:2 ratio into two groups , control and treated .
METHODS	The bone marrow mononuclear cells group received 1.06108 bone marrow mononuclear cells through mini-thoracotomy .
METHODS	There was no intervention in the control group .
METHODS	Assessment was carried out through clinical evaluations as well as a 6-min walk test , nuclear magnectic resonance imaging and echocardiogram .
RESULTS	The bone marrow mononuclear cells group showed a trend toward left ventricular ejection fraction improvement , with magnectic resonance imaging - at 3 months , showing an increase from 27.806.86 % to 30.139.06 % ( P = 0.08 ) and returning to baseline at 9 months ( 28.78 % , P = 0.77 ) .
RESULTS	Magnectic resonance imaging showed no changes in left ventricular ejection fraction during follow-up of the control group ( 28.004.32 % , 27.427.41 % , and 29.574.50 % ) .
RESULTS	Echocardiogram showed left ventricular ejection fraction improved in the bone marrow mononuclear cells group at 3 months , 25.093.98 to 30.949.16 ( P = 0.01 ) , and one year , 30.077.25 % ( P = 0.001 ) .
RESULTS	The control group showed no change ( 26.14.4 vs 26.54.7 and 30.27.39 % , P = 0.25 and 0.10 , respectively ) .
RESULTS	Bone marrow mononuclear cells group showed improvement in New York Heart Association functional class , from 3.400.50 to 2.410.79 ( P = 0.002 ) ; patients in the control group showed no change ( 3.370.51 to 2.710.95 ; P = 0.17 ) .
RESULTS	Six-minute walk test improved in the bone marrow mononuclear cells group ( 348.0093.51 m at baseline to 370.4191.56 m at 12 months , P = 0.66 ) and there was a non-significant decline in the control group ( 361.2590.78 m to 330.00123.42 m after 12 months , P = 0.66 ) .
RESULTS	Group comparisons were non-significant .
CONCLUSIONS	The trend of intragroup functional and subjective improvement was not confirmed when compared to the control group .
CONCLUSIONS	Direct intramyocardial application of bone marrow mononuclear cells in non-ischemic dilated cardiomyopathy was not associated with significant changes in left ventricular function .
CONCLUSIONS	Differences observed within the bone marrow mononuclear cells group could be due to placebo effect or low statistical power .

###26049614
OBJECTIVE	The aim of this study was to investigate whether infiltration of the upper eyelid skin is less painful with prilocaine than with lidocaine .
METHODS	In 40 consecutive patients scheduled for bilateral upper blepharoplasty , one upper eyelid was anaesthetised with lidocaine with epinephrine and the other with prilocaine with felypressin .
METHODS	After injection of each upper eyelid , the patient scored the pain experienced on infiltration using a visual analogue scale ( 0-10 ) .
METHODS	In addition , the surgeon scored the need for reinjection during the operation ; differences in perioperative bleeding ; and degree of oedema , erythema and haematoma before discharge on a four-point rating scale ( no , minimal , moderate or severe ) .
RESULTS	Pain scores were significantly lower in upper eyelids injected with lidocaine than in those injected with prilocaine ( p = 0.036 ) .
RESULTS	In addition , scores for oedema , erythema and haematoma were significantly lower in upper eyelids anaesthetised with lidocaine than in those anaesthetised with prilocaine ( respectively , p = 0.001 , p = 0.004 and p = 0.000 ) .
CONCLUSIONS	Compared with prilocaine with felypressin , lidocaine with epinephrine is significantly less painful in anaesthetising the upper eyelids ; gives significantly less postoperative oedema , erythema and haematoma ; and provides better haemostasis during upper blepharoplasty .
METHODS	This was a level II , randomised double-blinded crossover study .

###25559065
OBJECTIVE	The aim of this study was to investigate the potential drug-drug interaction between Bencycloquidium bromide ( BCQB ) and paroxetine , and between BCQB and roxithromycin .
METHODS	Two studies were conducted on healthy male Chinese volunteers .
METHODS	Study A was an open-label , two-period , one-sequence crossover study ( n = 21 ) .
METHODS	Each participant received a single nasal spray dose of BCQB 180g on day 1 .
METHODS	After a 7-day wash-out period , subjects received 20mg of paroxetine from day 8 to 17 , and were co-administered 20mg of paroxetine and BCQB 180g on day 18 .
METHODS	In study B , participants ( n = 12 ) were randomly assigned to two groups .
METHODS	In period I , group A received BCQB 180g on day 1 , followed by the same dose four times daily from day 4 to 10 , then , on day 11 a single dose of 150mg roxithromycin with BCQB 180g were co-administered .
METHODS	In parallel , group B received a single dose of roxithromycin 150mg on day 1 , followed by 300mg of roxithromycin from day 4 to 10 , then , on day 11 a single dose of BCQB 180g with roxithromycin 300mg were co-administered .
METHODS	After a wash-out time of 7days the respective treatments of each group ( A and B ) were swapped in period II .
METHODS	Blood samples were collected for pharmacokinetic analysis .
METHODS	Statistical comparison of pharmacokinetic parameters was performed to identify a possible drug interaction between treatments .
METHODS	Tolerability was evaluated by recording adverse events .
RESULTS	Study A : Geometric mean AUC0-36 for BCQB alone and co-administered with paroxetine were 474.3 and 631.3 pgh/ml , respectively .
RESULTS	The geometric mean ratio ( GMR ) of AUC0-36 was 1.33 ( 1.13-1 .46 ) , 90 % C.Is , and was out the predefined bioequivalence interval ( 90 % C.Is , 0.80-1 .25 ) .
RESULTS	Geometric mean Cmax were 187.0 and 181.2 pg/ml .
RESULTS	Study B : The GMR of AUC0-36 was 0.98 ( 0.90-1 .07 ) , 90 % C.Is for BCQB , and the GMR of AUC0-72 was 0.98 ( 0.87-1 .11 ) , 90 % C.Is for roxithromycin .
RESULTS	Both GMRs were within the predefined bioequivalence interval ( 90 % C.Is , 0.80-1 .25 ) .
RESULTS	Other pharmacokinetic parameters were within the predefined interval .
RESULTS	No serious adverse events were reported and no significant clinical changes were observed in laboratory test results , vital signs and ECGs in any of the studies .
RESULTS	All treatments were well tolerated .
CONCLUSIONS	The co-administration of BCQB with paroxetine showed a moderate increase in BCQB exposure , but was not clinically relevant .
CONCLUSIONS	Also , no drug interaction was found between BCQB and roxithromycin .

###24513787
OBJECTIVE	The aim of this study was to determine the safety and efficacy of induction with rabbit antithymocyte globulin ( RATG ) compared with interleukin-2 receptor antagonists in a racially diverse kidney transplant patient population under modern immunosuppression .
BACKGROUND	The optimal induction therapy in patients at risk for rejection , particularly black recipients , in the modern era of immunosuppression with flow cytometry-based cross-matching is unclear .
METHODS	This was a prospective , risk-stratified , randomized , single-center , open-label study of 200 consecutively enrolled patients in a large academic teaching center .
METHODS	Patients were randomized to receive either daclizumab or basiliximab versus RATG for induction in combination with tacrolimus , mycophenolate mofetil , and corticosteroids .
METHODS	Patients were stratified between groups to ensure equal numbers of black , retransplants , high panel reactive antibodies ( PRAs ) ( > 20 % ) , and prolonged cold ischemic times ( > 24 hours ) in each group .
METHODS	Primary outcome measure is treatment efficacy defined as the incidence of biopsy-proven acute rejection and estimated creatinine clearance .
METHODS	Patients were followed up for 12 months .
METHODS	Renal transplant recipients were included if they were adult ( 18 years old ) and received an allograft from a deceased , living unrelated , or nonhuman leukocyte antigen identical living-related donor .
RESULTS	A total of 200 patients ( n = 98 in the interleukin-2 receptor antagonists , and n = 102 in the RATG ) were enrolled from February 2009 through July 2011 .
RESULTS	One-year acute rejection rates were low and similar between groups ( 10 % in the interleukin-2 receptor antagonist group vs 6 % in the RATG group ; P = 0.30 ) .
RESULTS	Creatinine clearance was also similar between groups ( interleukin-2 receptor antagonist group 56 20 mL/min per 1.73 m2 vs RATG group 55 22 mL/min per 1.73 m2 ; P = 0.73 ) .
RESULTS	Subanalysis of recipient race revealed that in blacks only RATG was protective against 6 - and 12-month acute rejection , without an increased risk of infection .
RESULTS	Induction did not affect rejection rates according to recipient calculated PRAs ; however , RATG was associated with an increased risk of BK virus in low-PRA patients .
CONCLUSIONS	RATG induction provides improved protection against early acute rejection in black renal transplant recipients , whereas sensitized patients do not seem to demonstrate a similar benefit from this therapy .
CONCLUSIONS	This study is registered at Clinicaltrials.gov ( NCT00859131 ) .

###25340801
BACKGROUND	Postoperative adhesions constitute a substantial clinical problem in hand surgery .
BACKGROUND	Fexor tendon injury and repair result in adhesion formation around the tendon , which restricts the gliding function of the tendon , leading to decreased digit mobility and impaired hand recovery .
BACKGROUND	This study evaluated the efficacy and safety of the peptide PXL01 in preventing adhesions , and correspondingly improving hand function , in flexor tendon repair surgery .
METHODS	This prospective , randomised , double-blind trial included 138 patients admitted for flexor tendon repair surgery .
METHODS	PXL01 in carrier sodium hyaluronate or placebo was administered around the repaired tendon .
METHODS	Efficacy was assessed by total active motion of the injured finger , tip-to-crease distance , sensory function , tenolysis rate and grip strength , and safety parameters were followed , for 12 months post-surgery .
RESULTS	The most pronounced difference between the treatment groups was observed at 6 months post-surgery .
RESULTS	At this timepoint , the total active motion of the distal finger joint was improved in the PXL01 group ( 60 vs. 41 degrees for PXL01 vs. placebo group , p = 0.016 in PPAS ) .
RESULTS	The proportion of patients with excellent/good digit mobility was higher in the PXL01 group ( 61 % vs. 38 % , p = 0.0499 in PPAS ) .
RESULTS	Consistently , the PXL01 group presented improved tip-to-crease distance ( 5.0 vs. 15.5 mm for PXL01 vs. placebo group , p = 0.048 in PPAS ) .
RESULTS	Sensory evaluation showed that more patients in the PXL01 group felt the thinnest monofilaments ( FAS : 74 % vs. 35 % , p = 0.021 ; PPAS : 76 % vs. 35 % , p = 0.016 ) .
RESULTS	At 12 months post-surgery , more patients in the placebo group were considered to benefit from tenolysis ( 30 % vs. 12 % , p = 0.086 in PPAS ) .
RESULTS	The treatment was safe , well tolerated , and did not increase the rate of tendon rupture .
CONCLUSIONS	Treatment with PXL01 in sodium hyaluronate improves hand recovery after flexor tendon repair surgery .
CONCLUSIONS	Further clinical trials are warranted to determine the most efficient dose and health economic benefits .
BACKGROUND	ClinicalTrials.gov NCT01022242 ; EU Clinical Trials 2009-012703-25 .

###25663642
BACKGROUND	Free oxygen radicals might have an adverse effect on platelets which might be reflected either on its count and/or degree of bleeding severity .
OBJECTIVE	To assess oxidant-antioxidant systems and evaluate effect of antioxidant therapy on platelet count ( PC ) and bleeding score ( BS ) in children and adolescents with ITP .
METHODS	Six months prospective randomized single blind study registered as ( NCT 01763658 ) including 39 patients with newly diagnosed ( ND ) ITP ; group 1 ( G1 ) and 39 patients with chronic ITP ( G2 ) , each group was randomly allocated ( 2:1 ) to one of two subgroups respectively ; ( G1A and G2A ) interventional arm received daily antioxidant therapy , while G1B and G2B ; received a placebo .
METHODS	Both groups were compared with healthy controls ( n = 39 ) .
METHODS	The primary efficacy endpoints were the difference in the change from baseline to 6 month in ITP specific bleeding assessment tool ( ITP-BAT ) , PC , total antioxidant capacity ( TAC ) , catalase ( CAT ) , reduced glutathione ( GSH ) and serum malondialdehyde ( MDA ) .
RESULTS	Baseline TAC was significantly lower in patients with ( ND ) ITP compared to patients with chronic ITP ( P < 0.05 ) , both showed significantly lower levels than healthy controls ( P < 0.001 ) .
RESULTS	At end of study both BS and PC significantly improved in patients receiving antioxidant compared to placebo ( P < 0.05 ) .
RESULTS	Patients with chronic ITP receiving antioxidant showed better improvement .
CONCLUSIONS	Reduced antioxidant mechanisms were reported in patients with ITP .
CONCLUSIONS	Antioxidant therapy ameliorated the oxidative stress in both ND and chronic ITP groups which might explain the improvement in both BS and PC .

###24885637
BACKGROUND	The choice between operative or nonoperative treatment is questioned for partial articular fractures of the radial head that have at least 2 millimeters of articular step-off on at least one radiograph ( defined as displaced ) , but less than 2 millimeter of gap between the fragments ( defined as stable ) and that are not associated with an elbow dislocation , interosseous ligament injury , or other fractures .
BACKGROUND	These kinds of fractures are often classified as Mason type-2 fractures .
BACKGROUND	Retrospective comparative studies suggest that operative treatment might be better than nonoperative treatment , but the long-term results of nonoperative treatment are very good .
BACKGROUND	Most experts agree that problems like reduced range of motion , painful crepitation , nonunion or bony ankylosis are infrequent with both nonoperative and operative treatment of an isolated displaced partial articular fracture of the radial head , but determining which patients will have problems is difficult .
BACKGROUND	A prospective , randomized comparison would help minimize bias and determine the balance between operative and nonoperative risks and benefits .
METHODS	The RAMBO trial ( Radial Head - Amsterdam - Amphia - Boston - Others ) is an international prospective , randomized , multicenter trial .
METHODS	The primary objective of this study is to compare patient related outcome defined by the ` Disabilities of Arm , Shoulder and Hand ( DASH ) score ' twelve months after injury between operative and nonoperative treated patients .
METHODS	Adult patients with partial articular fractures of the radial head that comprise at least 1/3rd of the articular surface , have 2 millimeters of articular step-off but less than 2 millimeter of gap between the fragments will be enrolled .
METHODS	Secondary outcome measures will be the Mayo Elbow Performance Index ( MEPI ) , the Oxford Elbow Score ( OES ) , pain intensity through the ` Numeric Rating Scale ' , range of motion ( flexion arc and rotational arc ) , radiographic appearance of the fracture ( heterotopic ossification , radiocapitellar and ulnohumeral arthrosis , fracture healing , and signs of implant loosening or breakage ) and adverse events ( infection , nerve injury , secondary interventions ) after one year .
CONCLUSIONS	The successful completion of this trial will provide evidence on the best treatment for stable , displaced , partial articular fractures of the radial head .
BACKGROUND	The trial is registered at the Dutch Trial Register : NTR3413 .

###24809233
OBJECTIVE	The immunosuppressant tacrolimus is usually administered orally .
OBJECTIVE	When this is not feasible , other routes of administration may be useful .
OBJECTIVE	Previous research suggested that tacrolimus may be applied sublingually or rectally .
OBJECTIVE	Pharmacokinetic data are sparse .
OBJECTIVE	The aim of this study was to investigate and compare the pharmacokinetics of these alternative formulations with orally administered tacrolimus .
METHODS	Three single , fixed-dose formulations of tacrolimus were administered in a random sequence in 18 healthy subjects , using a cross-over study design .
METHODS	For sublingual administration , 3mg of powder obtained from oral capsules was applied under the tongue for a period of 15min without swallowing , with mouth rinsing afterwards .
METHODS	For rectal administration , a suppository containing 15mg of the oral powder was used .
METHODS	Oral administration consisted of 7mg of instant-release tacrolimus capsules ( Prograf ) .
METHODS	Main pharmacokinetic outcome parameters were compared by anova .
RESULTS	Sublingual administration showed no clinically significant exposure , contrary to rectal administration , where all subjects had clinically relevant exposure , with a lower relative bioavailability ( 78 % ) , a lower maximal blood concentration and a later time of maximal blood concentration compared with oral administration .
CONCLUSIONS	Sublingual administration of a single dose of tacrolimus does not result in systemic exposure if care is taken not to swallow saliva and to rinse the oral cavity afterwards .
CONCLUSIONS	Rectal administration of tacrolimus results in clinically relevant systemic exposure and might represent an alternative formulation in case oral administration is not feasible .
CONCLUSIONS	When used as a topical agent , systemic side-effects should be considered .

###24762588
BACKGROUND	Helicobacter pylori ( Hp ) is a common and potentially curable cause of gastric mucosa lesion .
BACKGROUND	This study investigated the relationship of Hp infection with histological changes in gastric mucosa and gastric cancer in Hp-positive patients compared with Hp-eradication patients followed up for ten years .
METHODS	From an initial group of 1 006 adults , 552 Hp-positive subjects were randomly assigned to a treatment group ( T ; n = 276 ) or a placebo group ( P ; n = 276 ) .
METHODS	In the randomized , double-blind , placebo-controlled , parallel trial , T group subjects received oral doses of omeprazole , amoxicillin and clarithromycin for 1 week ; those in the P group received a placebo .
METHODS	One month after treatment ended , a 13C urea breath test was performed , and Hp was undetectable in 88.89 % of the T group .
METHODS	All subjects were followed at 1 , 5 , 8 , and 10 years after treatment , with endoscopy and biopsies for histological examination .
RESULTS	Gastric mucosa inflammation was significantly milder in the T group than that in the P group one year after Hp eradication and this persisted for 10 years .
RESULTS	Glandular atrophy and intestinal metaplasia ( IM ) had deteriorated in both groups during ten years .
RESULTS	However , the increased score of glandular atrophy at both the gastric antrum and corpus , and IM only at the gastric antrum , in the P group was more obvious than that in the T group .
RESULTS	During the 10 years , 9 patients were diagnosed with gastric cancer ( 2 in the T group ; 7 in the P group ; P = 0.176 ) .
RESULTS	When mucosal atrophy was absent at the gastric antrum and corpus when entering the study , the incidence of gastric cancer in the P group ( n = 6 ) was much higher than that in the T group ( n = 0 , P = 0.013 ) .
CONCLUSIONS	Hp eradication may significantly diminish and help halt progression of gastric mucosal inflammation and delay the development of IM and atrophy gastritis .
CONCLUSIONS	Hp eradication is helpful for reducing the risk for gastric cancer , especially in the early stage of Hp infection .

###24588989
BACKGROUND	Pelvic adhesions are found in up to 50 % of women with CPP during investigative surgeries and adhesiolysis is often performed as part of their management although the causal or casual association of adhesions , and the clinical benefit of adhesiolysis in the context of CPP is still unclear .
BACKGROUND	Our aim was to test the hypothesis of whether laparoscopic adhesiolysis leads to significant pain relief and improvement in quality of life ( QoL ) in patients with chronic pelvic pain ( CPP ) and adhesions .
METHODS	This was a double-blinded RCT .
METHODS	This study was conducted in 2 tertiary referral hospitals in United Kingdom over 4years .
METHODS	Women with chronic pelvic pain ( CPP ) were randomized into having laparoscopic adhesiolysis or diagnostic laparoscopy .
METHODS	Women were assessed at 0 , 3 and 6months for Visual analogue scale scores ( VAS ) and Quality of Life ( QoL ) measures ( SF-12 and EHP-30 ) .
RESULTS	A total of 92 participants were recruited ; 50 qualified to be randomized , with 26 in the adhesiolysis and 24 in the control group .
RESULTS	The results are expressed in median ( interquartile ranges ) .
RESULTS	In women who underwent adhesiolysis , there was a significant improvement at 6months in VAS scores ( -17.5 ( -36.0 - -5.0 ) compared to controls ( -1.5 ( -15.0 - 4.5 ; p = 0.048 ) ; SF-12 scores physical component score ( 25.0 ( 18.8 - 43.8 ) ) compared to controls ( 6.3 ( -6.3 - 18.8 ) ; p = 0.021 ) , SF-12 emotional component score 32.5 ( 4.4 - 48.8 ) compared to controls -5 ( -21.3 - 15.0 ) ; p < 0.0074 ) and EHP-30 emotional well being domain 32.5 ( 4.4 - 48.8 ) compared to the controls -5 ( -21.3 - 15.0 ; p < 0.0074 ) .
CONCLUSIONS	This study stopped before recruitment reached the statistically powered sample size due to difficulty with enrollment and lack of continued funding .
CONCLUSIONS	In selected population of women presenting to the gynecological clinic with chronic pelvic pain , adhesiolysis in those who have adhesions may be of benefit in terms of improvement of pain and their quality of life .
BACKGROUND	ISRCTN 43852269 .

###25294647
OBJECTIVE	This study reports the long-term follow-up of the randomised controlled HEBE trial .
OBJECTIVE	The HEBE study is a multicentre trial that randomised 200 patients with large first acute myocardial infarction ( AMI ) treated with primary percutaneous coronary intervention to either intracoronary infusion of bone marrow mononuclear cells ( BMMCs ) ( n = 69 ) , peripheral blood mononuclear cells ( PBMCs ) ( n = 66 ) or standard therapy ( n = 65 ) .
METHODS	In addition to 3-5days , and 4months after AMI , all patients underwent cardiac MRI after 2years .
METHODS	A follow-up for 5years after AMI was performed to assess clinical adverse events , including death , myocardial reinfarction and hospitalisation for heart failure .
RESULTS	Of the 200 patients enrolled , 9 patients died and 12 patients were lost to follow-up at 5years after AMI .
RESULTS	BMMC group showed less increase in LV end-diastolic volume ( LVEDV ) ( 3.516.9 mL/m ( 2 ) ) compared with ( 11.219.8 mL/m ( 2 ) , p = 0.03 ) in the control group , with no difference between the PBMC group ( 9.220.9 mL/m ( 2 ) ) and controls ( p = 0.69 ) .
RESULTS	Moreover , the BMMC group showed a trend for decrease in LV end systolic volume ( -1.815.0 mL/m ( 2 ) ) as compared with controls ( 3.016.3 mL/m ( 2 ) , p = 0.07 ) , with again no difference between PBMC ( 3.318.8 mL/m ( 2 ) ) and controls ( p = 0.66 ) .
RESULTS	The combined endpoint of death and hospitalisation for heart failure was non-significantly less frequent in the BMMC group compared with the control group ( n = 4 vs n = 1 , p = 0.20 ) , with no difference between PBMC and controls ( n = 6 vs n = 4 , p = 0.74 ) .
RESULTS	The composite endpoint of death or recurrent myocardial infarction was significantly higher in the PBMC group compared with controls ( 14 patients vs 3 patients , p = 0.008 ) , with no difference between the BMMC group and controls ( 2 vs 3 patients , p = 0.67 ) .
CONCLUSIONS	Long-term follow-up of the HEBE trial showed that increase in LVEDV was lower in the BMMC group .
CONCLUSIONS	This study supports the long-term safety of intracoronary BMMC therapy .
CONCLUSIONS	However , major clinical cardiovascular adverse events were significantly more frequent in the PBMC group .
BACKGROUND	The Netherlands Trial Register #NTR 166 ( http://www.trialregister.nl ) and the International Standard Randomised Controlled Trial , #ISRCTN 95796863 ( http://isrctn.org ) .

###24980489
OBJECTIVE	Renal dysfunction is a common comorbidity in patients with heart failure and preserved ejection fraction ( HFpEF ) .
OBJECTIVE	We sought to determine whether renal dysfunction was associated with measures of cardiovascular structure/function in patients with HFpEF .
METHODS	We studied 217 participants from the PARAMOUNT study with HFpEF who had echocardiography and measures of kidney function .
METHODS	We evaluated the relationships between renal dysfunction [ estimated glomerular filtration rate ( eGFR ) > 30 and < 60 mL/min/1 .73 m ( 2 ) and/or albuminuria ] and cardiovascular structure/function .
RESULTS	The mean age of the study population was 71 years , 55 % were women , 94 % hypertensive , and 40 % diabetic .
RESULTS	Impairment of at least one parameter of kidney function was present in 62 % of patients ( 16 % only albuminuria , 23 % only low eGFR , 23 % both ) .
RESULTS	Renal dysfunction was associated with abnormal LV geometry ( defined as concentric hypertrophy , or eccentric hypertrophy , or concentric remodelling ) ( adjusted P = 0.048 ) , lower midwall fractional shortening ( MWFS ) ( P = 0.009 ) , and higher NT-proBNP ( P = 0.006 ) .
RESULTS	Compared with patients without renal dysfunction , those with low eGFR and no albuminuria had a higher prevalence of abnormal LV geometry ( P = 0.032 ) and lower MWFS ( P < 0.01 ) , as opposed to those with only albuminuria .
RESULTS	Conversely , albuminuria alone was associated with greater LV dimensions ( P < 0.05 ) .
RESULTS	Patients with combined renal impairment had mixed abnormalities ( higher LV wall thicknesses , NT-proBNP ; lower MWFS ) .
CONCLUSIONS	Renal dysfunction , as determined by both eGFR and albuminuria , is highly prevalent in HFpEF , and associated with cardiac remodelling and subtle systolic dysfunction .
CONCLUSIONS	The observed differences in cardiac structure/function between each type of renal damage suggest that both parameters of kidney function might play a distinct role in HFpEF .

###25127703
OBJECTIVE	The purpose of this study was to compare the safety and efficacy of a new cationic emulsion ( CE ) with a formulation of polyvinyl alcohol and povidone ( PVA-P ) for the treatment of mild to moderate dry eye disease .
METHODS	This was a multicenter , open-label , comparative study .
METHODS	Patients were randomised to receive CE ( Cationorm ) or PVA-P ( Refresh ) ( 1:1 ) .
METHODS	The following objective criteria were assessed to compare the two eye drops : tear Break-up Time ( TBUT ) , Schirmer 's test , lissamine green staining ( Van Bijsterveld score ) , corneal fluorescein staining ( Oxford scale ) and oculopalpebral examination , on D7 and D28 ( end of study ) .
METHODS	At these visits , ocular symptoms and safety were also assessed .
RESULTS	Seventy-nine patients were randomised : CE : 44 patients ; PVA-P : 35 patients .
RESULTS	At D28 , improvement was significantly better for TBUT [ CE : 1.7 2.4 s ; PVA-P : 0.6 1.8 s ; P = 0.015 ] and for the Van Bijsterveld score [ CE : -1.4 1.2 ; PVA-P : -0.9 1.2 ; P = 0.046 ] in the CE group .
RESULTS	The same applied for the palpebral erythema score ( P = 0.023 ) , overall efficacy assessed by the investigators ( P < 0.001 ) , and symptoms not related to eye drop instillation ( P = 0.021 ) .
RESULTS	Improvement was observed from D7 .
RESULTS	No difference was observed between the two treatments with regard to ocular safety .
CONCLUSIONS	These results suggest that in patients with mild to moderate dry eye , Cationorm , in addition to its moisturizing and lubricating properties , also helps stabilize the tear film due to its oily component .
CONCLUSIONS	This study demonstrates the benefit of this new pharmaceutical form for the treatment of mild to moderate dry eye disease .

###24267640
BACKGROUND	The EndoFlex is a new type of tracheal tube with an adjustable distal tip that can be bent without the use of a stylet .
BACKGROUND	The aim of this study was to compare a standard endotracheal tube with the EndoFlex tracheal tube for intubation in patients with simulated cervical spine injury .
METHODS	A group of 60 patients without any kind of the cervical spine injury , classified as the ASA physiological scale I or II and qualified for elective surgery procedures were intubated with the use of classical Macintosh laryngoscope , and either a standard endotracheal tube with the intubation stylet in it or EndoFlex tube without stylet .
METHODS	The subjects were randomized into two subgroups .
METHODS	All patients have had the cervical collar placed on their neck for the simulation of intubation procedure in case of the spinal injury .
RESULTS	The intubation procedure was performed by 16 anesthetists with different experience ( 5-19 yrs ) .
RESULTS	Time of intubation with the use of EndoFlex tube was similar to that with a the use of standard endotracheal tube and intubation stylet : Me ( median ) 19.5 s [ IQR ( interquatile range ) 18-50 ] vs. Me 20 s [ IQR 17-60 ] respectively ( p = 0.9705 ) .
RESULTS	No significant additional maneuvers were necessary during intubation with the use of EndoFlex tube in comparison with standard endotracheal tube ( 70 % vs. 56.6 % ) ( p = 0.4220 ) .
RESULTS	Subjective assessment of the usability of both tubes revealed that more anesthesiologists found intubations with the use of EndoFlex more demanding than intubation with conventional tracheal tube and intubation stylet .
RESULTS	The assessment of usability : very easy 3.3 % vs. 20 % , easy 83.4 % vs. 56.7 % , difficult 10 % vs. 20 % and very difficult 3.3 % vs. 3.3 % for standard endotracheal tube with stylet and EndoFlex , respectively .
CONCLUSIONS	In conclusion we asses , that the EndoFlex tube does not improve intubation success rate , in fact it requires more maneuvers facilitating intubation and was found to be more difficult to use .

###25200037
OBJECTIVE	The present study evaluated the efficacy of preoperative pregabalin for prevention of catheter-related bladder discomfort .
METHODS	Prospective , randomized , placebo controlled , double blinded study .
METHODS	Sixty patients of either sex undergoing elective spine surgery and requiring urinary bladder catheterization were randomly assigned to two groups .
METHODS	The patients in Group P ( pregabalin group ) received 150mg of pregabalin orally 1h prior to induction of anesthesia with sips of water and the patients in Group C ( control group ) received placebo .
METHODS	Anesthesia technique was identical in both the groups .
METHODS	Catheter-related bladder discomfort ( CRBD ) was evaluated on a 4-point scale ( 1 = no discomfort , 2 = mild , 3 = moderate , 4 = severe ) , on arrival ( 0h ) and again at 1 , 2 , and 6h postoperatively .
METHODS	Patients were provided patient-controlled analgesia with fentanyl for postoperative pain relief .
RESULTS	The incidence of CRBD was significantly less in the pregabalin group compared with the control group at all time intervals ( P < 0.05 ) .
RESULTS	The severity of CRBD was reduced in the pregabalin group compared with the control group at all time intervals except 6h .
RESULTS	The postoperative consumption of fentanyl was significantly less in group P , while the sedation score was significantly higher in the group P compared to group C.
CONCLUSIONS	Pretreatment with pregabalin 150mg prevents CRBD and also decreases postoperative fentanyl consumption .
CONCLUSIONS	Clinical Trials.gov identifier : ( ref : CTRI/2013/11 / 004170 ) .

###25203380
BACKGROUND	Many patients report discomfort because of the unpleasant taste of bowel preparation solutions .
OBJECTIVE	This study aimed to determine whether adding orange juice to 2 L of polyethylene glycol plus ascorbic acid is effective for reducing patient discomfort and improving palatability during bowel preparation .
METHODS	This was a single-blinded , randomized controlled trial .
METHODS	The study was conducted at a tertiary referral hospital and a generalized hospital .
METHODS	Consecutive outpatients and inpatients were randomly allocated to drink 2 L of polyethylene glycol-ascorbic acid or 2 L of polyethylene glycol-ascorbic acid with orange juice in a single dose or a split dose .
METHODS	Tolerability , palatability score , willingness , and related adverse events were investigated by questionnaires .
METHODS	Bowel cleansing was rated using the Aronchick scale .
METHODS	Each score was graded on a 5-point scale .
RESULTS	A total of 107 patients , 53 in the orange juice group and 54 in the polyethylene glycol-ascorbic acid group who underwent elective colonoscopy were enrolled .
RESULTS	The palatability score ( mean SD ) was higher in the orange juice group than in the control group ( 2.36 0.76 vs 1.78 0.88 ; p = 0.005 ) .
RESULTS	Nausea was less frequent in the orange juice group ( 26.4 % vs 59.3 % ; p = 0.001 ) .
RESULTS	Total amount of bowel preparation ingested was not significantly different between the groups ( p = 0.44 ) .
RESULTS	The bowel preparation score ( mean SD ) was not significantly different ( 1.49 0.80 vs 1.43 0.77 ; p = 0.94 ) .
RESULTS	Willingness to repeat the same process was higher in the orange juice group ( 90.4 % vs 66.7 % ; p = 0.003 ) .
CONCLUSIONS	This study is limited because only ambulatory patients were enrolled .
CONCLUSIONS	Orange juice intake before drinking 2 L of polyethylene glycol-ascorbic acid for colonoscopy can reduce patient discomfort , resulting in improved acceptability and patient compliance .
CONCLUSIONS	This method is as effective for bowel cleansing as polyethylene glycol .

###25176015
BACKGROUND	We compared the angiotensin receptor-neprilysin inhibitor LCZ696 with enalapril in patients who had heart failure with a reduced ejection fraction .
BACKGROUND	In previous studies , enalapril improved survival in such patients .
METHODS	In this double-blind trial , we randomly assigned 8442 patients with class II , III , or IV heart failure and an ejection fraction of 40 % or less to receive either LCZ696 ( at a dose of 200 mg twice daily ) or enalapril ( at a dose of 10 mg twice daily ) , in addition to recommended therapy .
METHODS	The primary outcome was a composite of death from cardiovascular causes or hospitalization for heart failure , but the trial was designed to detect a difference in the rates of death from cardiovascular causes .
RESULTS	The trial was stopped early , according to prespecified rules , after a median follow-up of 27 months , because the boundary for an overwhelming benefit with LCZ696 had been crossed .
RESULTS	At the time of study closure , the primary outcome had occurred in 914 patients ( 21.8 % ) in the LCZ696 group and 1117 patients ( 26.5 % ) in the enalapril group ( hazard ratio in the LCZ696 group , 0.80 ; 95 % confidence interval [ CI ] , 0.73 to 0.87 ; P < 0.001 ) .
RESULTS	A total of 711 patients ( 17.0 % ) receiving LCZ696 and 835 patients ( 19.8 % ) receiving enalapril died ( hazard ratio for death from any cause , 0.84 ; 95 % CI , 0.76 to 0.93 ; P < 0.001 ) ; of these patients , 558 ( 13.3 % ) and 693 ( 16.5 % ) , respectively , died from cardiovascular causes ( hazard ratio , 0.80 ; 95 % CI , 0.71 to 0.89 ; P < 0.001 ) .
RESULTS	As compared with enalapril , LCZ696 also reduced the risk of hospitalization for heart failure by 21 % ( P < 0.001 ) and decreased the symptoms and physical limitations of heart failure ( P = 0.001 ) .
RESULTS	The LCZ696 group had higher proportions of patients with hypotension and nonserious angioedema but lower proportions with renal impairment , hyperkalemia , and cough than the enalapril group .
CONCLUSIONS	LCZ696 was superior to enalapril in reducing the risks of death and of hospitalization for heart failure .
CONCLUSIONS	( Funded by Novartis ; PARADIGM-HF ClinicalTrials.gov number , NCT01035255 . )

###24828019
METHODS	This study was conducted to determine the effects of folate supplementation on metabolic profiles in obese women with polycystic ovary syndrome ( PCOS ) .
RESULTS	This randomized double-blind placebo-controlled clinical trial was conducted among 81 obese women ( weight range : 65-110 kg ) aged 18-40 year old diagnosed with PCOS .
RESULTS	Participants were randomly assigned to three groups receiving : ( 1 ) Folate-1 : 1 mg/day folate supplements ( n = 27 ) ; ( 2 ) Folate-5 : 5 mg/day folate supplements ( n = 27 ) , and ( 3 ) placebo ( n = 27 ) for 8 weeks .
RESULTS	Fasting blood samples were taken at baseline and after 8 weeks ' intervention to quantify glucose metabolism and lipid concentrations .
RESULTS	Folate supplementation ( 5 mg ) , compared with folate-1 and placebo , resulted in reduced plasma homocysteine ( p-interaction = 0.009 ) , homeostasis model of assessment-insulin resistance score ( p-interaction = 0.01 ) , and total cholesterol/HDL-C ratio ( p-interaction = 0.01 ) .
RESULTS	Furthermore , we found a significant difference in mean change of serum total cholesterol ( p-interaction = 0.01 ) , LDL - ( p-interaction = 0.007 ) , and non-HDL-cholesterol levels ( p = 0.01 ) in the folate-5 group compared with folate-1 and placebo .
CONCLUSIONS	5 mg/day folate supplementation for 8 weeks among women with PCOS had beneficial effects on metabolic profiles .

###25834495
BACKGROUND	Patients with Pulmonary Tuberculosis ( PTB ) often develop impairment in pulmonary function due to anatomical changes secondary to the illness .
BACKGROUND	Physiotherapy in the form of pulmonary rehabilitation has been advocated .
OBJECTIVE	The aim of the study was to determine whether adherence to a six-week home-based pulmonary rehabilitation programme ( PRP ) improved the baseline measurements of lung function , exercise tolerance and health-related quality of life ( HRQoL ) in patients receiving out-patient treatment for PTB .
METHODS	A single blinded randomized control study design was used to assess the effects of a six-week home - based PRP in patients receiving treatment for PTB at a local clinic in Khayelitsha , Western Cape .
METHODS	We evaluated lung function by spirometry ( MINATO AUTOSPIRO-model no .
METHODS	AZ-505 ) , exercise tolerance using the 6-min-walk test ( 6MWT ) , the Borg exercise exertion scale and HRQoL using the EQ-5 D questionnaire in an intervention group ( n = 34 ) and a control group ( n = 33 ) .
METHODS	The trend of the effects of the PRP on lung function was towards increases , but there was no statistical difference between the intervention and control groups at the end of the sixth week in the values of FVC ( p = 0.2 ; 95 % CI -0.9 to 0.51 ) as well as FEV1 ( p = 0.1 ; 95 % CI -0.07 to 0.51 ) .
METHODS	Similar trend was observed for exercise tolerance , and there was no significant difference in HRQoL ( p = 0.789 ) .
CONCLUSIONS	The outcome of the study provides motivation for further consideration and implementation of a pulmonary rehabilitation programme for patients with PTB .

###24583745
BACKGROUND	Although the potential advantages of the Endocut mode ( E-mode ) of endoscopic sphincterotomy ( EST ) over the conventional blended cut mode ( C-mode ) have been reported , the problems , including the small sample size and retrospective analysis , that occurred in previous studies make it difficult to conclude the advantage of the E-mode regarding the safety and efficacy .
BACKGROUND	We performed a prospective randomized controlled study to compare these modes .
METHODS	A total of 360 patients with choledocholithiasis or stenosis of the bile duct were randomly assigned to one of the modes .
METHODS	To avoid the technical bias due to multiple operators or institutions , the main operator and the institution were restricted to only one experienced doctor and 3 institutions at his place of employment , respectively .
METHODS	We defined pancreatitis , bleeding , and perforation as complications of EST. .
METHODS	Besides , bleeding includes endoscopically evident bleeding that was defined as visible during the procedure of sphincterotomy and temporary slight oozing .
RESULTS	The complications occurred in 20 ( 11.2 % ) patients from the E-mode group : pancreatitis in 6 ( 3.4 % ) and endoscopically evident bleeding in 14 ( 7.8 % ) .
RESULTS	In contrast , the complications occurred in 25 ( 13.8 % ) patients from the C-mode group : pancreatitis in 7 ( 3.9 % ) and endoscopically evident bleeding in 18 ( 9.9 % ) , although these findings were not statistically significant .
RESULTS	Overall , there were no severe complications .
RESULTS	There were no significant differences in completion ratio of EST and the time taken for the sphincterotomy between both groups .
CONCLUSIONS	The E-mode could not surpass the C-mode in safety and efficacy under the operation by a single endoscopist .

###24341301
OBJECTIVE	This study aims to evaluate the efficacy and tolerability of vortioxetine 2.5 - , 5 - and 10-mg once-daily doses vs. placebo in the treatment of generalised anxiety disorder ( GAD ) .
METHODS	In this 8-week , multicentre , double-blind , placebo-controlled , parallel-group , phase 3 study , patients with a primary GAD diagnosis were randomised to receive placebo ( n = 157 ) , vortioxetine 2.5 mg , vortioxetine 5 mg , vortioxetine 10 mg or duloxetine 60 mg once daily ( n = 156 each ) .
METHODS	The primary end-point , mean change from baseline in Hamilton Anxiety Scale ( HAM-A ) total score and key secondary end-points for the 5 - and 10-mg vortioxetine doses were analysed in a prespecified sequential testing procedure ( all at week 8 ) .
METHODS	Sexual dysfunction was evaluated using the Arizona Sexual Experiences Scale .
RESULTS	Differences from placebo in the primary efficacy end-point were not statistically significant for the vortioxetine groups .
RESULTS	The mean difference from placebo was significant in the duloxetine arm .
RESULTS	For all secondary efficacy end-points , results were similar among the vortioxetine groups and did not reach statistical significance .
RESULTS	The vortioxetine 10-mg group showed separation from placebo on the Hospital Anxiety and Depression anxiety subscore ( nominal p = 0.036 ) .
RESULTS	Duloxetine 60 mg significantly improved the primary end-point ( p < 0.05 vs. placebo ) , validating the study .
RESULTS	Nausea , dry mouth , diarrhoea , nasopharyngitis , headache , dizziness , somnolence , vomiting , dyspepsia , constipation and fatigue were reported in 5 % of patients receiving vortioxetine .
RESULTS	Rates of treatment-emergent sexual dysfunction ( TESD ) in the vortioxetine dosing groups were similar to placebo .
CONCLUSIONS	In this study , vortioxetine 2.5 - , 5 - and 10-mg once-daily doses showed no significant improvement in HAM-A total scores vs. placebo .
CONCLUSIONS	Vortioxetine was well tolerated at all doses and was not associated with TESD .

###25756440
OBJECTIVE	The need for surgery for the majority of patients with displaced proximal humeral fractures is unclear , but its use is increasing .
OBJECTIVE	To evaluate the clinical effectiveness of surgical vs nonsurgical treatment for adults with displaced fractures of the proximal humerus involving the surgical neck .
METHODS	A pragmatic , multicenter , parallel-group , randomized clinical trial , the Proximal Fracture of the Humerus Evaluation by Randomization ( PROFHER ) trial , recruited 250 patients aged 16 years or older ( mean age , 66 years [ range , 24-92 years ] ; 192 [ 77 % ] were female ; and 249 [ 99.6 % ] were white ) who presented at the orthopedic departments of 32 acute UK National Health Service hospitals between September 2008 and April 2011 within 3 weeks after sustaining a displaced fracture of the proximal humerus involving the surgical neck .
METHODS	Patients were followed up for 2 years ( up to April 2013 ) and 215 had complete follow-up data .
METHODS	The data for 231 patients ( 114 in surgical group and 117 in nonsurgical group ) were included in the primary analysis .
METHODS	Fracture fixation or humeral head replacement were performed by surgeons experienced in these techniques .
METHODS	Nonsurgical treatment was sling immobilization .
METHODS	Standardized outpatient and community-based rehabilitation was provided to both groups .
METHODS	Primary outcome was the Oxford Shoulder Score ( range , 0-48 ; higher scores indicate better outcomes ) assessed during a 2-year period , with assessment and data collection at 6 , 12 , and 24 months .
METHODS	Sample size was based on a minimal clinically important difference of 5 points for the Oxford Shoulder Score .
METHODS	Secondary outcomes were the Short-Form 12 ( SF-12 ) , complications , subsequent therapy , and mortality .
RESULTS	There was no significant mean treatment group difference in the Oxford Shoulder Score averaged over 2 years ( 39.07 points for the surgical group vs 38.32 points for the nonsurgical group ; difference of 0.75 points [ 95 % CI , -1.33 to 2.84 points ] ; P = .48 ) or at individual time points .
RESULTS	There were also no significant between-group differences over 2 years in the mean SF-12 physical component score ( surgical group : 1.77 points higher [ 95 % CI , -0.84 to 4.39 points ] ; P = .18 ) ; the mean SF-12 mental component score ( surgical group : 1.28 points lower [ 95 % CI , -3.80 to 1.23 points ] ; P = .32 ) ; complications related to surgery or shoulder fracture ( 30 patients in surgical group vs 23 patients in nonsurgical group ; P = .28 ) , requiring secondary surgery to the shoulder ( 11 patients in both groups ) , and increased or new shoulder-related therapy ( 7 patients vs 4 patients , respectively ; P = .58 ) ; and mortality ( 9 patients vs 5 patients ; P = .27 ) .
RESULTS	Ten medical complications ( 2 cardiovascular events , 2 respiratory events , 2 gastrointestinal events , and 4 others ) occurred in the surgical group during the postoperative hospital stay .
CONCLUSIONS	Among patients with displaced proximal humeral fractures involving the surgical neck , there was no significant difference between surgical treatment compared with nonsurgical treatment in patient-reported clinical outcomes over 2 years following fracture occurrence .
CONCLUSIONS	These results do not support the trend of increased surgery for patients with displaced fractures of the proximal humerus .
BACKGROUND	isrctn.com Identifier : ISRCTN50850043 .

###24890170
BACKGROUND	First generation drug-eluting stents ( DES ) were associated with a high incidence of late stent thrombosis ( ST ) , mainly due to delayed healing and re-endothelization by the durable polymer coating .
BACKGROUND	This study sought to assess the safety and efficacy of the Nano polymer-free sirolimus-eluting stent ( SES ) in the treatment of patients with de novo coronary artery lesions .
METHODS	The Nano trial is the first randomized trial designed to compare the safety and efficacy of the Nano polymer-free SES and Partner durable-polymer SES ( Lepu Medical Technology , Beijing , China ) in the treatment of patients with de novo native coronary lesions .
METHODS	The primary endpoint was in-stent late lumen loss ( LLL ) at 9-month follow-up .
METHODS	The secondary endpoint was major adverse cardiac events ( MACE ) , a composite of cardiac death , myocardial infarction or target lesion revascularization .
RESULTS	A total of 291 patients ( Nano group : n = 143 , Partner group : n = 148 ) were enrolled in this trial from 19 Chinese centers .
RESULTS	The Nano polymer-free SES was non-inferior to the Partner durable-polymer DES at the primary endpoint of 9 months ( P < 0.001 ) .
RESULTS	The 9-month in-segment LLL of the polymer-free Nano SES was comparable to the Partner SES ( 0.34 0.42 ) mm vs. ( 0.30 0.48 ) mm , P = 0.21 ) .
RESULTS	The incidence of MACE in the Nano group were 7.6 % compared to the Partner group of 5.9 % ( P = 0.75 ) at 2 years follow-up .
RESULTS	The frequency of cardiac death and stent thrombosis was low for both Nano and Partner SES ( 0.8 % vs. 0.7 % , 0.8 % vs. 1.5 % , both P = 1.00 ) .
CONCLUSIONS	In this multicenter randomized Nano trial , the Nano polymer-free SES showed similar safety and efficacy compared with the Partner SES in the treatment of patients with de novo coronary artery lesions .
CONCLUSIONS	Trials in patients with complex lesions and longer term follow-up are necessary to confirm the clinical performance of this novel Nano polymer-free SES .

###26403745
OBJECTIVE	To investigate the effect of parenteral nutrition support with a lipid emulsion formulation ( containing soybean oil , medium chain triglycerides , olive oil , and fish oil [ SMOF ] ) in intensive care patients following major gastrointestinal surgeries .
METHODS	According to a randomized , prospective and case-controlled design , 72 intensive care patients following major gastrointestinal surgeries between January and December , 2014 were randomized equally into SMOF group and control group to receive parenteral nutrition support with SMOF and medium or long chain lipid emulsion , respectively .
METHODS	Before and at 4 and 9 days after commencement of parenteral nutrition support , the patients were examined for alanine aminotransferase ( ALT ) , total bilirubin ( TBIL ) , albumin ( propagated ) , C-reactive protein ( CRP ) , interleukin 6 ( IL-6 ) , and endotoxin levels .
METHODS	The patients ' average length of stay in intensive care unit ( ICU ) , the days of using antibiotics , and the incidence rate of postoperative complication were recorded .
RESULTS	On day 4 postoperatively , the levels of CRP and IL-6 were significantly lower in SMOF group than in the control group ( t = 2.669 and 2.676 , respectively ; P < 0.05 ) , and on day 9 , the patients in SMOF group showed significantly lower levels of ALT , TBIL , CRP and IL-6 ( t = 2.487 , 3.497 , 3.762 , 2.180 , respectively ; P < 0.05 ) than the control group , but ALB and endotoxin levels remained comparable between the two groups .
RESULTS	The average length of stay in ICU and the days of using antibiotics were significantly shorter in SMOF group than in the control group ( t = 2.94 and 2.17 , respectively ; P < 0.05 ) ; SMOF group showed a lower incidence of postoperative infections than the control group , but the difference was not statistically significant ( = 1.047 , P > 0.05 ) .
CONCLUSIONS	For intensive care patients following major gastrointestinal surgeries , postoperative parenteral nutrition support with SMOF can effectively reduce the release of inflammatory mediators , protect important visceral functions , reduce postoperative complications , shorten the length of ICU stay , and improve the prognosis of the patients .

###24349392
BACKGROUND	Physical activity ( PA ) interventions typically include components or doses that are static across participants .
BACKGROUND	Adaptive interventions are dynamic ; components or doses change in response to short-term variations in participant 's performance .
BACKGROUND	Emerging theory and technologies make adaptive goal setting and feedback interventions feasible .
OBJECTIVE	To test an adaptive intervention for PA based on Operant and Behavior Economic principles and a percentile-based algorithm .
OBJECTIVE	The adaptive intervention was hypothesized to result in greater increases in steps per day than the static intervention .
METHODS	Participants ( N = 20 ) were randomized to one of two 6-month treatments : 1 ) static intervention ( SI ) or 2 ) adaptive intervention ( AI ) .
METHODS	Inactive overweight adults ( 85 % women , M = 36.9 9.2 years , 35 % non-white ) in both groups received a pedometer , email and text message communication , brief health information , and biweekly motivational prompts .
METHODS	The AI group received daily step goals that adjusted up and down based on the percentile-rank algorithm and micro-incentives for goal attainment .
METHODS	This algorithm adjusted goals based on a moving window ; an approach that responded to each individual 's performance and ensured goals were always challenging but within participants ' abilities .
METHODS	The SI group received a static 10,000 steps/day goal with incentives linked to uploading the pedometer 's data .
RESULTS	A random-effects repeated-measures model accounted for 180 repeated measures and autocorrelation .
RESULTS	After adjusting for covariates , the treatment phase showed greater steps/day relative to the baseline phase ( p < .001 ) and a group by study phase interaction was observed ( p .017 ) .
RESULTS	The SI group increased by 1,598 steps/day on average between baseline and treatment while the AI group increased by 2,728 steps/day on average between baseline and treatment ; a significant between-group difference of 1,130 steps/day ( Cohen 's d = .74 ) .
CONCLUSIONS	The adaptive intervention outperformed the static intervention for increasing PA. .
CONCLUSIONS	The adaptive goal and feedback algorithm is a `` behavior change technology '' that could be incorporated into mHealth technologies and scaled to reach large populations .
BACKGROUND	ClinicalTrials.gov NCT01793064 .

###24271056
OBJECTIVE	Prior chemotherapy may affect the efficacy of endocrine therapy .
METHODS	The tamoxifen exemestane adjuvant multinational ( TEAM ) trial compared 5years of adjuvant exemestane with the sequence of tamoxifen followed by exemestane in postmenopausal women with hormone-receptor-positive breast cancer .
METHODS	A total of 1,502 patients were enrolled in Germany ( 739 received tamoxifen followed by exemestan and 610 exemestan alone ) .
METHODS	A retrospective analysis of the German cohort of TEAM was conducted to determine whether prior chemotherapy affected clinical outcome of endocrine therapy .
RESULTS	Overall survival , disease-free survival and distant recurrence were similar between patients who received sequential therapy and those who received exemestane monotherapy , irrespective of prior chemotherapy .
RESULTS	Overall survival was not significantly different between patients who had received prior chemotherapy and those who had not ( P = 0.2836 ) .
RESULTS	Disease-free survival and distant recurrence were significantly better in patients who had not received prior chemotherapy versus those who had ( P = 0.0308 and P = 0.0001 ) .
RESULTS	In patients receiving sequential therapy , there were no significant differences in overall survival according to prior chemotherapy use ( P = 0.1812 ) .
RESULTS	However , disease-free survival and distant recurrence were significantly different dependent on prior chemotherapy ( P = 0.0143 and P = 0.0053 ) .
CONCLUSIONS	In conclusion , there was no difference in overall survival between breast cancer patients who did receive prior chemotherapy before endocrine therapy and those who had not .
CONCLUSIONS	Patients who had not received prior chemotherapy had significantly improved disease-free survival and less distant recurrence versus those who had received chemotherapy .

###25285531
OBJECTIVE	An open-label phase I/II study of single-agent obatoclax determined a maximum tolerated dose ( MTD ) and schedule , safety , and efficacy in older patients ( 70 yr ) with untreated acute myeloid leukemia ( AML ) .
METHODS	Phase I evaluated the safety of obatoclax infused for 3 hours on 3 consecutive days ( 3 h 3 d ) in 2-week cycles .
METHODS	Initial obatoclax dose was 30 mg/day ( 3 h 3 d ; n = 3 ) .
METHODS	Obatoclax was increased to 45 mg/day ( 3 h 3 d ) if 1 patient had a dose-limiting toxicity ( DLT ) and decreased to 20 mg/day ( 3 h 3 d ) if DLT occurred in 2 patients .
METHODS	In the phase II study , 12 patients were randomized to receive obatoclax at the dose identified during phase I ( 3 h 3 d ) or 60 mg/day administered by continuous infusion over 24 hours for 3 days ( 24 h 3 d ) to determine the morphologic complete response rate .
RESULTS	In phase I , two of three patients receiving obatoclax 30 mg/day ( 3 h 3 d ) experienced grade 3 neurologic DLTs ( confusion , ataxia , and somnolence ) .
RESULTS	Obatoclax was decreased to 20 mg/day ( 3 h 3 d ) .
RESULTS	In phase II , no clinically relevant safety differences were observed between the 20 mg/day ( 3 h 3 d ; n = 7 ) and 60 mg/day ( 24 h 3 d ; n = 5 ) arms .
RESULTS	Neurologic and psychiatric adverse events were most common and were generally transient and reversible .
RESULTS	Complete response was not achieved in any patient .
CONCLUSIONS	Obatoclax 20 mg/day was the MTD ( 3 h 3 d ) in older patients with AML .
CONCLUSIONS	In the schedules tested , single-agent obatoclax was not associated with an objective response .
CONCLUSIONS	Evaluation in additional subgroups or in combination with other chemotherapy modalities may be considered for future study .
BACKGROUND	ClinicalTrials.gov NCT00684918 .

###24273297
BACKGROUND	Although inpatient stroke rehabilitation provides clinicians with the opportunity to prepare patients for continuation of prestroke activities , little is known about the patients ' ability to safely resume driving at the point of discharge to the community .
OBJECTIVE	To compare foot pedal response times of 20 stroke patients with right hemiplegia ( RH ) or left hemiplegia ( LH ) and 10 controls .
METHODS	A cross-sectional design was used .
METHODS	Response times were measured using 3 foot pedal operation techniques : ( 1 ) right-sided accelerator with right leg operating accelerator and brake , ( 2 ) right-sided accelerator with left leg operating accelerator and brake , and ( 3 ) left-sided accelerator with left leg operating accelerator and brake .
METHODS	Outcomes included reaction time ( RT ) , movement time ( MT ) , and total response time ( TRT ) .
RESULTS	Controls demonstrated faster RT than patients with RH ( 263 vs 348 ms ; P < .001 ) or LH ( 316 ms ; P < .05 ) for all conditions , as well as faster MT than patients with RH ( P < .05 for all ) but not LH when using the right leg ( 258 vs 251 ms ; P = .82 ) .
RESULTS	Controls demonstrated faster TRT than patients with RH ( P < .001 for all ) but not LH when using the right leg ( 515 vs 553 ms ; P = .44 ) .
CONCLUSIONS	When using the nonparetic leg , patients with LH had braking response times comparable to controls , but patients with RH demonstrated significant impairment of both the paretic and nonparetic legs .

###24724863
BACKGROUND	A recent randomized trial compared a policy of no prophylaxis with a policy of prophylactic platelet ( PLT ) transfusions at counts of fewer than 1010 ( 9 ) / L in patients with hematologic malignancies .
BACKGROUND	The results suggested the effectiveness of prophylactic PLT transfusions may vary according to patient diagnosis and treatment plan .
METHODS	This article presents full subgroup analyses and compares treatment effects between autologous hematopoietic stem cell transplantation ( autoHSCT ; n = 421 ) and chemotherapy/allogeneic HSCT ( chemo/alloHSCT ; n = 179 ) patients .
RESULTS	Prespecified subgroup analysis found that the reduction in proportion of patients experiencing WHO Grade 2 to 4 bleeds ( main trial outcome ) seen in the prophylaxis arm was of greater magnitude in chemo/alloHSCT than autoHSCT patients ( interaction p = 0.04 ) .
RESULTS	Analysis of secondary outcomes showed a shorter time to first bleeding episode with no prophylaxis in the chemo/alloHSCT group ( hazard ratio , 1.84 ; 95 % confidence interval CI , 1.21-2 .79 ; p = 0.004 ) compared to the autoHSCT group ( hazard ratio , 1.12 ; 95 % CI , 0.85-1 .48 ; p = 0.4 ; interaction p = 0.08 ) .
RESULTS	The increased number of days with Grade 2 to 4 bleeds with a no-prophylaxis policy was similar in chemo/alloHSCT ( rate ratio , 1.89 ; 95 % CI , 1.10-3 .26 ) and in autoHSCT patients ( rate ratio , 1.43 ; 95 % CI , 1.04-1 .97 ) .
RESULTS	Both subgroups showed significant reductions in PLT transfusions with a no-prophylaxis strategy .
CONCLUSIONS	There is evidence that the effectiveness of prophylactic PLT transfusions may differ between subgroups , with chemo/alloHSCT patients receiving prophylactic PLT transfusions appearing to show a greater reduction in bleeding outcomes compared to patients following a no-prophylaxis policy .

###25451608
BACKGROUND	Experimental animal studies provided evidence for a synergistic effect of immunological and psychological stressors on subsequent sickness behaviours .
BACKGROUND	Up to now , little corroborating evidence for such synergy exists for humans , in whom it may provide a mechanism leading to the expression of functional somatic symptoms .
BACKGROUND	The aim of the present study was to determine an interaction between stress ( - vulnerability ) and an immunological activation on experimental pain sensitivity , i.e. , pressure pain threshold and tolerance in healthy humans .
METHODS	In healthy female participants ( n = 25 , mean age 22.3 years ) , negative affectivity ( NA ) and experienced stress were assessed by questionnaire before receiving a Salmonella typhi vaccine or saline control in a randomized blinded cross-over design .
METHODS	Pressure pain threshold was assessed at the lower back and calves and pain tolerance was assessed at the thumbnail , before and six hours after each injection .
RESULTS	Vaccination induced leukocytosis ( +100 % ) and increased serum IL-6 ( +670 % ) .
RESULTS	NA predicted decreased pain tolerance after vaccination ( = -.57 , p = .007 ) , but not after placebo ( = .25 , p = .26 ) .
RESULTS	Post-hoc analyses also demonstrated an association with administration order .
CONCLUSIONS	NA moderated the effects of inflammation on pain tolerance .
CONCLUSIONS	This finding is consistent with a synergistic model whereby inflammation may lower the threshold for pain reporting in individuals with increased vulnerability for somatic symptom reporting .

###25229781
BACKGROUND	Devices such as diode laser and intense pulsed light ( IPL ) are in constant development aiming at permanent hair removal , but there are few comparative studies between these technologies .
OBJECTIVE	The objective was to comparatively assess axillary hair removal performed by diode laser and IPL and to obtain parameters of referred pain and evolution response for each method .
METHODS	A comparative prospective , double-blind , and randomized study of axillary hair removal performed by the diode laser and IPL was conducted in 21 females .
METHODS	Six sessions were held with application of the diode laser in one axilla and the IPL in the other , with intervals of 30 days and follow-up of 6 months after the last session .
METHODS	Clinical photographs and digital dermoscopy for hair counts in predefined and fixed fields of the treated areas were performed before , 2 weeks after the sixth session , and 6 months after the end of treatment .
METHODS	A questionnaire to assess the pain was applied .
RESULTS	The number of hair shafts was significantly reduced with the diode laser and IPL .
RESULTS	The diode laser was more effective , although more painful than the IPL .
RESULTS	No serious , adverse , or permanent effects were observed with both technologies .
CONCLUSIONS	Both diode laser and the IPL are effective , safe , and able to produce lasting results in axillary hair removal .

###24938836
OBJECTIVE	Stroke treatment is constrained by limited treatment windows and the clinical inefficacy of agents that showed preclinical promise .
OBJECTIVE	Yet animal and clinical data suggest considerable poststroke plasticity , which could allow treatment with recovery-modulating agents .
OBJECTIVE	Memantine is a well-tolerated N-methyl-D-aspartate glutamate receptor antagonist in common use for Alzheimer disease .
METHODS	Memantine , 30 mg/kg per day , or vehicle , was delivered chronically in drinking water beginning > 2 hours after photothrombotic stroke .
RESULTS	Although there was no difference in infarct size , behavior , or optical intrinsic signal maps in the first 7 days after stroke , mice treated chronically with memantine showed significant improvements in motor control , measured by cylinder test and grid-walking performance , compared with vehicle-treated animals .
RESULTS	Optical intrinsic signal revealed an increased area of forepaw sensory maps at 28 days after stroke .
RESULTS	There was decreased reactive astrogliosis and increased vascular density around the infarcted cortex .
RESULTS	Peri-infarct Western blots revealed increased brain-derived neurotrophic factor and phosphorylated-tropomyosin-related kinase-B receptor expression .
CONCLUSIONS	Our results suggest that memantine improves stroke outcomes in an apparently non-neuroprotective manner involving increased brain-derived neurotrophic factor signaling , reduced reactive astrogliosis , and improved vascularization , associated with improved recovery of sensory and motor cortical function .
CONCLUSIONS	The clinical availability and tolerability of memantine make it an attractive candidate for clinical translation .

###24691504
OBJECTIVE	To demonstrate benefits for speech perception and everyday listening in quiet and in noise with a speech-enhancement strategy called ClearVoice , which was designed to improve listening in complex acoustic environments without compromising hearing in quiet .
METHODS	A 2-week randomized crossover design was used to evaluate ClearVoice in 46 adults unilaterally implanted with a CII/HiRes 90K cochlear implant who had at least 6 months experience with HiRes Fidelity 120 sound processing .
METHODS	Speech perception was assessed using the AzBio sentences presented in quiet , in speech-spectrum noise and in multitalker babble .
METHODS	Subjective listening benefit and strategy preference were assessed with a questionnaire .
METHODS	ClearVoice has 3 gain settings ( low , medium , and high ) , each intended as a full-time listening option according to individual preference .
METHODS	Speech understanding after acute use of ClearVoice-low was compared with HiRes Fidelity 120 during an initial test session .
METHODS	Speech perception abilities were compared with HiRes Fidelity 120 after 2 weeks of exclusive use of ClearVoice-medium , and after 2 weeks of exclusive use of ClearVoice-high .
METHODS	During a fifth week , participants were fit with 3 programs for comparison ( HiRes Fidelity 120 , ClearVoice-medium , and ClearVoice-high ) , after which , they reported preference and everyday listening benefits via a questionnaire .
RESULTS	ClearVoice significantly improved speech understanding in speech-spectrum noise and multitalker babble , did not compromise listening in quiet , was preferred for everyday listening , and provided improved hearing in real-life situations .
CONCLUSIONS	ClearVoice improves hearing in noise for cochlear implant recipients who use HiRes Fidelity 120 sound processing .

###24484241
BACKGROUND	Acute pulmonary embolism ( PE ) can worsen quality of life due to persistent dyspnea or exercise intolerance .
OBJECTIVE	Test if tenecteplase increases the probability of a favorable composite patient-oriented outcome after submassive PE .
METHODS	Normotensive patients with PE and right ventricular ( RV ) strain ( by echocardiography or biomarkers ) were enrolled from eight hospitals .
METHODS	All patients received low-molecular-weight heparin followed by random assignment to either a single weight-based bolus of tenecteplase or placebo , administered in a double-blinded fashion .
METHODS	The primary composite outcome included : ( i ) death , circulatory shock , intubation or major bleeding within 5days or ( ii ) recurrent PE , poor functional capacity ( RV dysfunction with either dyspnea at rest or exercise intolerance ) or an SF36 ( ) Physical Component Summary ( PCS ) score < 30 at 90-day follow-up .
RESULTS	Eighty-three patients were randomized ; 40 to tenecteplase and 43 to placebo .
RESULTS	The trial was terminated prematurely .
RESULTS	Within 5days , adverse outcomes occurred in three placebo-treated patients ( death in one and intubation in two ) and one tenecteplase-treated patient ( fatal intracranial hemorrhage ) .
RESULTS	At 90days , adverse outcomes occurred in 13 unique placebo-treated patients and five unique tenecteplase-treated patients Thus , 16 ( 37 % ) placebo-treated and six ( 15 % ) tenecteplase-treated patients had at least one adverse outcome ( exact two-sided P = 0.017 ) .
CONCLUSIONS	Treatment of patients with submassive pulmonary embolism with tenecteplase was associated with increased probability of a favorable composite outcome .

###24957863
OBJECTIVE	We investigated whether the prokinetic activity of mosapride , a 5-hydroxytryptamine 4 receptor agonist , in combination with proton pump inhibitor ( PPI ) would ameliorate symptoms of gastroesophageal reflux disease ( GERD ) in Japanese patients .
METHODS	Patients who experienced reflux symptoms more than twice weekly were eligible for this study .
METHODS	In all , 60 patients were randomized to receive mosapride 5mg thrice daily combined with omeprazole 10mg once daily ( GO group ) , or omeprazole alone ( O group ) for 4 weeks .
METHODS	The patients completed the frequency scale for the symptoms of GERD ( FSSG ) at the beginning and the end of the study .
METHODS	The primary outcome compared changes in the FSSG reflux-related symptom ( RS ) score between treatment groups during the study period .
RESULTS	The FSSG RS scores significantly decreased both in the GO group and the O group , with no differences in improvement between the groups ( -5.86 for the GO group vs -4.89 for the O group , P = 0.49 ) .
RESULTS	In non-erosive reflux disease ( NERD ) patients the improvement was significantly lower than that in erosive GERD patients ( -4.00 vs -7.67 , P = 0.02 ) .
RESULTS	However , the addition of mosapride was effective in subgroup analyses of specific symptoms , such as burping .
CONCLUSIONS	Combining mosapride with PPI provided no additional amelioration of reflux symptoms compared to PPI alone .
CONCLUSIONS	Both regimens provided less relief from reflux symptoms in NERD than in erosive GERD patients .
CONCLUSIONS	The addition of mosapride ameliorated reflux in patients with symptoms like burping .

###25343656
OBJECTIVE	Web-based personalized feedback interventions , particularly personalized normative feedback ( PNF ) , are efficacious in improving college drinking outcomes ; however , no personalized feedback interventions to date have provided college drinkers with feedback about their own decisional balance .
OBJECTIVE	This study tested the relative efficacy of a novel decisional balance feedback ( DBF ) intervention , PNF , and an assessment-only control condition .
METHODS	Participants ( N = 724 ; 56 % female ) were undergraduate students at a 4-year university in the U.S. Pacific Northwest and were randomized to receive one-time exposure to web-based DBF , PNF , or assessment only .
METHODS	Web-based assessment occurred at baseline and at 1 - , 6 - , and 12-month follow-ups and included measures of motivation to change , drinking quantity norms , drinking frequency/quantity , and alcohol-related problems .
RESULTS	At the 1-month follow-up , DBF and PNF participants reported reductions in alcohol-related problems ; however , only PNF participants reduced their drinking frequency and quantity .
RESULTS	At the 6-month follow-up , only DBF participants showed significant reductions in drinking quantity and alcohol-related problems .
RESULTS	Neither group maintained reductions in alcohol use or alcohol-related problems at the 12-month follow-up .
CONCLUSIONS	This study provided preliminary evidence that web-based DBF and PNF are efficacious interventions for college drinkers , with DBF having somewhat longer lasting effects .

###24439191
OBJECTIVE	To evaluate the efficacy and safety of prophylactic ceftazidime on early bacterial infection in APBSCT recipients during neutropenia .
METHODS	APBSCT recipients were prospectively randomly assigned to intravenous ceftazidime treatment group and control group ( no prophylaxis of antibiotics ) .
METHODS	The treatment started from the first day until resolution of neutropenia or the appearance of early bacterial infection .
RESULTS	From March 2010 to January 2013 , 70 APBSCT recipients were enrolled in the study with 36 in treatment and 34 in control group .
RESULTS	Overall , 29 ( 41.4 % ) patients developed early bacterial infection , among which , 9 ( 25.0 % ) in the treatment group and 20 ( 58.8 % ) in the control group ( P = 0.004 ) .
RESULTS	The median infection free survival ( IFS ) was not reached in the treatment group and was 8 days in the control group ( P = 0.005 ) .
RESULTS	Despite whether patients received single high dose melphalan or other conditioning regimes , the early bacterial infection rate was lower in the treatment group than in the control group , and the median IFS was longer in the treatment group than that in the control group .
RESULTS	The mean courses of antibiotic administration were ( 8.08 2.03 ) days and ( 3.68 3.56 ) days respectively in the treatment and control groups ( P < 0.001 ) .
RESULTS	However , the duration of empirical carbapenems were ( 1.67 3.03 ) days and ( 3.68 3.56 ) days respectively ( P = 0.013 ) .
RESULTS	There was no significant difference of antibiotics cost per patient between the two groups .
RESULTS	Four patients in the treatment group had a transient elevated serum creatinine .
RESULTS	Overall , no infection related mortality was observed in either group .
CONCLUSIONS	Prophylaxis of intravenous ceftazidime for APBSCT recipients is effective in preventing early bacterial infection with an acceptable toxicity and cost profile .
CONCLUSIONS	However , it does n't have effect on infection related mortality .
CONCLUSIONS	Therefore , our results do not support the use of antibiotic prophylaxis for patients undergoing APBSCT .

###24660584
OBJECTIVE	To observe the curative effect of a recipe for warming the kidney and fortifying the spleen on diarrhea-predominant irritable bowel syndrome ( IBS-D ) .
METHODS	This multi-center , double-blind , randomized , and controlled trial included 240 patients that met the inclusion criterion and were then divided into two groups of 120 .
METHODS	Patients in the treatment group ( group A ) took modified Sishen Wan orally for warming the kidney and fortifying the spleen and patients in the control group ( group B ) took a placebo , Chao Maiya , for 4 weeks .
METHODS	28 days after withdrawal , there was a 6-month follow-up to observe patient recurrence condition .
METHODS	The total effective rate , curative effect , and recurrence rate were evaluated after treatment .
RESULTS	There was statistical difference ( P < 0.01 ) between the two groups in total effective rate ( 92.24 % in the treatment group and 49.07 % in the control group ) , in curative effect of TCM syndrome ( 90.52 % and 47.22 % , respectively ) , and in the recurrence rate ( 15.79 % and 56.86 % , respectively ) within 6 months after treatment .
CONCLUSIONS	Modified Sishen Wan , for warming the kidney and fortifying the spleen , can effectively treat IBS-D and better control its recurrence .

###24658945
OBJECTIVE	The purpose of this study was to explore the feasibility of high-intensity focused ultrasound combined with sonographically guided intratumoral ethanol injection in the treatment of uterine fibroids and to compare its therapeutic effects and potential side effects with those of simple high-intensity focused ultrasound treatment .
METHODS	Forty patients with uterine fibroids from the Department of Ultrasonography in our hospital were randomly divided into 2 groups of the same size : group H , which only underwent high-intensity focused ultrasound treatment ; and group H + A , which underwent sonographically guided intratumoral ethanol injection therapy first and then high-intensity focused ultrasound treatment the following day .
METHODS	The treatment times , treatment doses , pain scores , side effects , and therapeutic effect rates of the groups were then recorded and compared .
RESULTS	Both the treatment time and dose of group H + A were significantly less than those of group H , and the differences were statistically significant ( P < .05 ) .
RESULTS	A lower pain score and fewer side effects were achieved in group H + A , also with statistically significant differences ( P < .05 ) .
RESULTS	The therapeutic effect rate of group H + A was also higher than that of group H , and the difference was also statistically significant ( P < .05 ) .
CONCLUSIONS	In the treatment of uterine fibroids , high-intensity focused ultrasound combined with sonographically guided intratumoral ethanol injection requires less treatment time and a lower dose than simple high-intensity focused ultrasound treatment and significantly reduces the pain and side effects commonly experienced by patients .
CONCLUSIONS	High-intensity focused ultrasound combined with sonographically guided intratumoral ethanol injection is a feasible , safe , and more effective way to treat patients with uterine fibroids .

###25539239
OBJECTIVE	The purpose of this study was to compare 5-minute delayed transitional phase imaging using a 30 flip angle ( hereafter , 5 min-FA30 ) and 20-minute hepatocyte phase imaging using a 10 flip angle ( hereafter , 20 min-FA10 ) in gadoxetic acid-enhanced MRI for focal hepatic lesion detection and lesion-to-liver contrast-to-noise ratio ( CNR ) , and to determine whether 5 min-FA30 could replace 20 min-FA10 with a 15-minute time saving .
METHODS	One hundred sixteen patients with 282 focal hepatic lesions ( size range , 0.2-12 .5 cm ; malignant , n = 146 ; benign , n = 136 ) underwent gadoxetic acid-enhanced MRI with 5 min-FA30 and 20 min-FA10 with a 3D T1-weighted gradient-echo sequence .
METHODS	Three radiologists independently assessed the presence of focal hepatic lesions using a 4-point scale , and detection sensitivity of focal hepatic lesions was calculated .
METHODS	Lesion-to-liver CNRs were calculated and compared in two image groups .
RESULTS	There was no significant difference in detection sensitivity of focal hepatic lesions for all three readers between 5 min-FA30 ( mean , 95.4 % ) and 20 min-FA10 ( mean , 95.6 % ) , irrespective of lesion size or malignancy .
RESULTS	The mean CNR on 5 min-FA30 ( 167.9 84.1 ) was significantly higher than that on 20 min-FA10 ( 160.2 79.5 ) .
RESULTS	However , the mean CNR difference between the two image groups was relatively small ( 7.8 41.9 ) .
CONCLUSIONS	Compared with 20 min-FA10 , 5 min-FA30 provided higher CNR and similar sensitivity .
CONCLUSIONS	These findings indicate that 5 min-FA30 could replace 20-min delayed hepatocyte phase imaging using a 10 flip angle with similar diagnostic performance and 15 minutes of time saving .

###24565934
OBJECTIVE	Perineal reeducation of stress urinary incontinence is beneficial in 80 % of cases .
OBJECTIVE	However , patients have to perform self-retraining exercises of the perineal muscles at home , in order to maintain the benefit of the physiotherapy .
OBJECTIVE	The aim of this study is to assess the benefit of GYNEFFIK ( ) , a perineal electro-stimulator , during this home-care phase .
METHODS	Women with stress urinary incontinence ( UI ) or with mixed UI ( composed predominantly of stress UI ) that responded to physiotherapy were included in this study in two parallel groups .
METHODS	The groups followed a self-reeducation program , with or without GYNEFFIK ( ) electro-stimulation sessions .
METHODS	The comparison of the two groups was based on the rate of women for whom the benefit of the initial perineal reeducation was maintained ( defined as non-worsening ICIQ and Ditrovie scales ' score ) .
RESULTS	According to the protocol , an interim analysis was performed on 95 patients ( i.e. almost half of the expected sample size ) who had had at least one evaluation under treatment , among which 44 patients had finished the study .
RESULTS	The therapeutic benefit of the initial perineal reeducation was maintained in 87.8 % of the GYNEFFIK ( ) patient group , while it was maintained in 52.2 % ( P = 0.0001 ) in the usual care group ( i.e. who did not use electro-stimulation ) .
CONCLUSIONS	Likewise , patient had a more favorable subjective impression when using GYNEFFIK ( ) ( 83.7 % versus 60.0 % in the usual care group ) as they felt that they improved during the study .
CONCLUSIONS	In the GYNEFFIK ( ) group , no increase in symptoms was reported , whereas almost one out of five patients in the usual care group felt that their condition had worsened .

###24499495
OBJECTIVE	The 1R ,2 S stereoisomer of methoxamine hydrochloride , NRL001 , is a highly selective 1-adrenoceptor agonist being developed for the local treatment of non-structural faecal incontinence caused by weak internal anal sphincter tone .
OBJECTIVE	This study investigated the steady state pharmacokinetics ( PK ) and safety of 2 g rectal suppositories containing NRL001 in different strengths ( 7.5 , 10 , 12.5 or 15 mg ) .
METHODS	Healthy volunteers aged 18-45 years received 14 daily doses of NRL001 2 g suppositories or matching placebo .
METHODS	In each dose group nine participants received NRL001 and three received placebo .
METHODS	Blood samples to determine NRL001 concentrations were taken on Days 1 , 7 and 14 .
METHODS	Cardiovascular parameters were collected via electrocardiograms , Holter monitoring ( three lead Holter monitor ) and vital signs .
RESULTS	Forty-eight volunteers were enrolled ; 43 completed the study and were included in the PK analysis population .
RESULTS	AUC and Cmax broadly increased with increasing dose , Tmax generally occurred between 4.0 and 5.0 h. Although the data did not appear strongly dose proportional , dose proportionality analysis did not provide evidence against dose proportionality as the log ( dose ) coefficients were not significantly < 1 .
RESULTS	NRL001 did not accumulate over time for any dose .
RESULTS	Increasing NRL001 concentrations were related to changes in vital sign variables , most notably decreased heart rate .
RESULTS	The most commonly reported adverse events ( AEs ) in the active treatment groups were paraesthesia and piloerection .
CONCLUSIONS	Treatment with NRL001 was generally well tolerated over 14 days once daily dosing and plasma NRL001 did not accumulate over time .
CONCLUSIONS	Treatment was associated with changes in vital sign variables , most notably decreased heart rate .
CONCLUSIONS	AEs commonly reported with NRL001 treatment were events indicative of a systemic - adrenergic effect .

###24813099
OBJECTIVE	To show whether a clinically significant difference in success rates exists between expectant and surgical management of early pregnancy loss .
METHODS	Randomised controlled trial comparing expectant versus surgical management of early pregnancy loss over a 1-year period from 1st January to 31st December 2009 at Sultanah Aminah Hospital , Johor Bahru .
METHODS	Pregnant women with missed or incomplete miscarriages at gestations up to 14 weeks were recruited in this study .
METHODS	The success rate in the surgical group was measured as curettage performed without any complications during or after the procedure , while the success rate in the expectant group was defined as complete spontaneous expulsion of products of conception within 6 weeks without any complication .
RESULTS	A total of 360 women were recruited and randomised to expectant or surgical management , with 180 women in each group .
RESULTS	There was no statistically significant difference in the success rate between the groups and between the different types of miscarriage .
RESULTS	With expectant management , 131 ( 74 % ) patients had a complete spontaneous expulsion of products of conception , of whom 106 ( 83 % ) women miscarried within 7 days .
RESULTS	However , the rates of unplanned admissions ( 18.1 % ) and unplanned surgical evacuations ( 17.5 % ) in the expectant group were significantly higher than the rates ( 7.4 % and 8 % respectively ) in the surgical group .
RESULTS	The complications in both groups were similar .

###24517055
OBJECTIVE	To observe the clinical effect and safety of modified Bushen Zhuanggu Recipe ( BZR ) in treating ankylosing spondylitis ( AS ) .
METHODS	Recruited were 96 AS outpatients of Shen deficiency induced cold-dampness syndrome ( SDCDS ) or Shen deficiency dampness-heat syndrome ( SDDHS ) at clinics of China-Japan Friendship Hospital from May 2010 to May 2011 .
METHODS	They were randomly assigned to the traditional Chinese medicine ( TCM ) treatment group and the Western medicine ( WM ) treatment group in the ratio of 1:1 .
METHODS	Those in the TCM treatment group were syndrome typed as the SDCDS group ( group A , 22 cases , treated by Bushen Zhuanggu Quhan Decoction + WM placebos ) and the SDDHS group ( group B , 26 cases , treated by Bushen Zhuanggu Qinghua Decoction + WM placebos ) .
METHODS	Those in the WM treatment group were syndrome typed as SDCDS group ( group C , 27 cases , treated by SASP + TCM placebos ) and the SDDHS group ( group D , 21 cases , treated by SASP + TCM placebos ) .
METHODS	Totally 12 weeks consisted of one therapeutic course .
METHODS	BAS-G , BASFI , BASDAI , spine pain , pain at night , TCM symptom score , distance between occipital and wall , distance between finger and ground , thoracic activity , spine activity , Schober test , ESR , CRP were observed as the observing indices ; ASAS20 , ASAS50 , ASAS70 , BASDAI50 , and criteria of TCM were explored for clinical evaluation and safety evaluation .
RESULTS	In comparison with the same group before treatment,BAS-G , BASFI , BASDAI , spine pain , pain at night , TCM syndrome score , distance between finger and ground , Schober test , ESR , and CRP were improved after treatment ( P < 0.01 , P < 0.05 ) .
RESULTS	In group A and C , thoracic activity and spine activity were getting better ( P < 0.01 , P < 0.05 ) .
RESULTS	In group B distance between occipital and wall and spine activity were getting better ( P < 0.01 , P < 0.05 ) .
RESULTS	In comparison with group C , BAS-G , BASFI , BASDAI , spine pain , distance between finger and ground , thoracic activity , spine activity , Schober test , ESR , CRP were getting better in group A after treatment ( P < 0.01 , P < 0.05 ) .
RESULTS	In comparison with group D , BASFI , BASDAI , spine pain , pain at night , distance between finger and ground , distance between occipital and wall , spine activity , Schober test , and ESR were getting better in group B after treatment ( P < 0.01 , P < 0.05 ) .
RESULTS	The total effective rate , ASAS20 , ASAS50 , ASAS70 , and BASDAI50 were higher in the TCM treatment group than in the WM treatment group ( P < 0.05 ) .
CONCLUSIONS	Modified BZR was more effective than SASP method in relieving clinical symptoms and signs , TCM syndrome scores , and inflammatory activity indicators of AS patients .

###25644328
BACKGROUND	Statins are currently the preferred pharmacological therapy in individuals with familial hypercholesterolemia ( FH ) with the aim to prevent premature atherosclerosis .
BACKGROUND	In adults , these agents have been proven to be safe and well tolerated ; however , non-adherence is a significant clinical issue .
OBJECTIVE	In this study , we evaluated tolerability and adherence to statin therapy in young adult FH patients 10 years after this was initiated in their childhood .
METHODS	A questionnaire including items on medical history , adherence and reasons for discontinuation was sent to 214 young adult FH patients that initiated statin therapy at least 10 years ago .
METHODS	Tolerability was defined as 100 % minus the percentage of patients that discontinued statin therapy due to side effects .
METHODS	Adherence was defined as the extent to which patients took their medication as prescribed by their physician .
METHODS	We labelled patients adherent if they took 80 % or more of their pills in the month preceding our assessment .
RESULTS	Follow-up was successful in 205 ( 95.8 % ) subjects ( age 18-30 years ) .
RESULTS	A history of side effects was reported by 40 ( 19.5 % ) of the patients , and mainly consisted of muscle complaints and gastrointestinal symptoms .
RESULTS	Three patients ( 1.5 % ) discontinued statin therapy because of side effects .
RESULTS	Rhadbomyolysis or other serious adverse events were not reported .
RESULTS	In fact , 169 ( 82.4 % ) of 205 patients remained on statin treatment and 78.7 % ( 148 out of 188 ) were adherent .
RESULTS	None of the patient characteristics were significantly associated with adherence .
CONCLUSIONS	Individuals with FH who started statin therapy in childhood demonstrated good adherence during ten years of treatment .
CONCLUSIONS	Furthermore , statin therapy was well tolerated ; only a small minority discontinued therapy because of side effects and the side effects that were reported were mild in nature .

###25599738
BACKGROUND	Delayed graft function ( DGF ) is a consequence of ischemia-reperfusion injuries in kidney allografts , for which no definite treatment is available .
BACKGROUND	The neutrophil gelatinase-associated lipocalin ( NGAL ) and interleukin-18 ( IL-18 ) are introduced as the most promising urine biomarkers to detect DGF .
BACKGROUND	N-acetylcysteine ( NAC ) and vitamin C , well-known potent antioxidants that scavenge free radicals , may alleviate kidney injury .
BACKGROUND	This study investigated the protective effects of NAC alone and in combination with vitamin C on DGF , by measuring IL-18 and NGAL in living donor kidney transplantations .
METHODS	Patients transplanted between January 2011 and February 2013 were randomly divided into 3 groups to receive routine anti-rejection medication only ( n = 32 ) , NAC plus routine immunosuppressive regimen ( NAC group ; n = 33 ) , and NAC and vitamin C plus routine regimen ( NAC and vitamin C group ; n = 19 ) .
METHODS	Urine samples were taken 4 hours and 24 hours after transplantation .
METHODS	Enzyme-linked immunosorbent assay kits were utilized for measuring urine NGAL and IL-18 .
RESULTS	There were no significant differences in the DGF prevalence and its duration between the study arms .
RESULTS	Although the levels of NGAL and IL-18 decreased in the NAC and NAC and vitamin C groups , these reductions were not significant .
RESULTS	Glomerular filtration rate at 30 and 60 days after transplantation were not significantly different between study groups , either .
CONCLUSIONS	Our results showed that NAC is a safe drug without significant adverse effects in kidney transplant recipients ; however , its potential useful effects on urinary biomarkers of DGF were not illustrated in the present study .

###25301892
BACKGROUND	The purpose of this study was to determine whether obtaining a radiograph of the uninjured contralateral calcaneus ( template ) before surgery allowed for more precise restoration of Bohler 's angle and calcaneal length when performing open reduction internal fixation ( ORIF ) of intra-articular calcaneus fractures .
METHODS	Patients who sustained an intra-articular calcaneus fracture requiring surgery who met inclusion criteria were prospectively randomized into those who had a preoperative template obtained for review at the time of ORIF ( group 1 ) versus those who had the contralateral radiograph obtained after surgery ( group 2 ) .
RESULTS	There was no benefit of the preoperative template in allowing for more anatomic restoration of Bohler 's angle or calcaneal length .
RESULTS	Operative time was decreased with the use of a preoperative template when using the extensile lateral or percutaneous approaches .
CONCLUSIONS	Preoperative templating of the uninjured contralateral calcaneus did not allow for more anatomic reduction or restoration of pre-injury morphology of the calcaneus undergoing operative fixation as based on Bohler 's angle and calcaneal length .
CONCLUSIONS	Templating may be of benefit by reducing operative time .
METHODS	Level II , prospective comparative series .

###24568169
OBJECTIVE	To determine the effectiveness of a water flosser in reducing the bleeding on probing ( BOP ) index around dental implants as compared to flossing .
METHODS	Patients with implants were randomly assigned to one of two groups in this examiner-masked , single-center study .
METHODS	The study compared the efficacy of a manual toothbrush paired with either traditional string floss or a water flosser .
RESULTS	The primary outcome was the reduction in the incidence of BOP after 30 days .
RESULTS	There were no differences in the percent of bleeding sites between the groups at baseline .
RESULTS	At 30 days , 18 of the 22 ( 81.8 % ) implants in the water flosser group showed a reduction in BOP compared to 6 of the 18 ( 33.3 % ) in the floss group ( P = 0.0018 ) .
CONCLUSIONS	These results demonstrate that the water flosser group had statistically significantly greater bleeding reduction than the string floss group .
CONCLUSIONS	The authors concluded that water flossing may be a useful adjuvant for implant hygiene maintenance .

###24695369
BACKGROUND	In Saudi Arabia many studies have addressed cigarette smoking from various perspectives .
BACKGROUND	Most of these studies , however , were conducted among males and confined to Riyadh , the capital city .
BACKGROUND	Such limitations have enhanced the need for community-based epidemiological studies that include both genders and various age groups and socio-demographic features , as well as different regions .
OBJECTIVE	This cross-sectional study aims to assess the prevalence of cigarette smoking and to discuss the association between cigarette smoking habits and socio-demographic factors among community members of the Jazan area in southwest Saudi Arabia .
METHODS	A pre-coded questionnaire was designed and tested for data consistency .
METHODS	A well-trained health team was assigned to gather the data from the 30 primary healthcare centers distributed across eight provinces .
METHODS	The response rate was 92.8 % ( 4,326 respondents 13 years old ) .
METHODS	The associations among the subjects ' socio-demographic characteristics were examined by the chi-square test .
METHODS	A multiple logistic regression and odds ratios were calculated as well .
RESULTS	A total of 1,017 ( 23.5 % ) , 1,042 ( 24.1 % ) , and 3,284 ( 75.9 % ) respondents were , respectively , current smokers ( TCS ) , ever-smokers ( TES ) , and non-smokers ( TNS ) .
RESULTS	Though current smokers seem to be more prevalent in urban populations ( 13.8 % ) than in rural populations ( 9.7 % ) , the association of urbanization with a current smoking habit is insignificant .
CONCLUSIONS	Having fun , relieving stress , and the influence of parents , particularly of mothers , were the main motives that encouraged participants ' cigarette-smoking habits .
CONCLUSIONS	This situation was worsened by the fact that accessing cigarettes was either very easy or easy for over 90 % of the respondents .

###24492988
OBJECTIVE	To evaluate the efficacy and safety of holmium laser enucleation of the prostate ( HoLEP ) and transurethral resection of the prostate ( TURP ) , for treatment of benign prostatic hyperplasia ( BPH ) .
METHODS	A total of 164 cases of BPH were selected from patients who were hospitalized between January 2010 and December 2011 .
METHODS	Patients had received either HoLEP or TURP treatment .
METHODS	Clinical data were collected from the perioperative period , 1 month after surgery , and 12 months after surgery .
RESULTS	There was no significant difference between the two groups in the maximum urinary flow rate ( Q max ) , postvoid residual volume ( PVR ) , international prostate symptom score ( IPSS ) , or quality-of-life score ( QOL score ) at 1 month after surgery ( p = 0.56 , p = 0.346 , p = 0.536 and p = 0.145 , respectively ) .
RESULTS	However , after 12 months , patients from the HoLEP group demonstrated better scores in Qmax , PVR , IPSS , and QOL than those from the TURP group ( p = 0.037 , p = 0.003 , p < 0.001 and p = 0.019 , respectively ) .
RESULTS	The two groups had comparable operation time ( p = 0.105 ) , catheterization time ( p = 0.173 ) , and length of hospital stay ( p = 0.395 ) , but were statistically different in the weight of resected prostate tissue ( p < 0.001 ) , bladder irrigation time ( p < 0.001 ) , hemoglobin levels ( p = 0.011 ) , and blood sodium levels ( p = 0.002 ) after surgery .
CONCLUSIONS	Compared to TURP , HoLEP was safer and had better long-term efficacy as assessed by multiple quantitative measures .
CONCLUSIONS	Therefore , HoLEP may present a better option in the treatment of BPH .

###25392204
BACKGROUND	Young people in South Africa are at high risk of HIV infection and yet may have more limited access to prevention and treatment services than others in the population .
BACKGROUND	Testing facilitates the sharing of prevention messages but also enables the linkage to care and treatment of those who test positive and therefore has wider public health implications .
METHODS	This baseline survey conducted in 2005 for a community randomized trial in rural KwaZulu-Natal explored factors associated with a history of ever , repeat and recent testing amongst sexually debuted men and women aged 18 to 32 years .
RESULTS	Over 35 % of this rural population ever tested for HIV , with men less likely to ever ( unadjusted OR 0.26 , 95 % CI : 0.21-0 .32 ) and repeatedly test than women ( adjusted OR ( aOR ) 0.68 , 95 % CI : 0.48-0 .97 ) .
RESULTS	Men aged 24-28 years ( aOR 2.02 , 95 % CI : 1.10-3 .71 ) and 29-32 years ( aOR 2.69 , 95 % CI : 1.46-4 .94 ) were more likely to ever test than those < 20 years .
RESULTS	Those who reported having discussed HIV with others had significantly greater odds of reporting ever ( men 's aOR 2.83 , 95 % CI : 1.63-4 .89 ; women 's aOR 3.36 , 95 % CI : 2.50-4 .53 ) , recent ( irrespective of sex , aOR 2.87 , 95 % CI : 2.02-4 .09 ) and repeat testing ( aOR 2.02 , 95 % CI : 1.28-3 .19 ) .
CONCLUSIONS	These findings highlight the need for novel youth - and men-friendly testing services and emphasises the importance of discussions about HIV in the home and community to encourage testing .

###25503280
BACKGROUND	The purpose of the present study was to evaluate the effects of six-week aerobic training program including running and rope skipping on cardiovascular fitness , body mass index ( BMI ) , and mental health among female students at the University of Isfahan , Iran .
METHODS	In this interventional study we included 30 female students in academic year 2011-12 .
METHODS	The participants were randomly assigned in experimental group ( n = 15 , meanSD for age = 26.061.18 , weight ( kg ) = 57.435.67 , height ( cm ) = 160.064.16 ) and control group ( n = 15 , meanSD for age = 26.331.30 , weight = 57.665.08 , height = 161.863.29 ) .
METHODS	Pre-test and post-test measurements include VO2 max with Queen Step test ; BMI and General Health Questionnaire-28 as a measure of mental health were done .
METHODS	Analysis of covariance ( ANCOVA ) was used to test the effects of aerobic training as intervention ( P < 0.05 ) .
RESULTS	There was statistically significance difference between experimental and control groups after adjustment for their own baseline values concerning cardiovascular fitness ( P = 0.004 ) , BMI ( P < 0.001 ) and mental health indices ( P < 0.001 ) .
CONCLUSIONS	A six-week aerobic practice improves cardiovascular strength , mental health and BMI considerably and could be more encouraged at universities .

###25338798
OBJECTIVE	To explore the necessity of periodontal-pulp combined therapy for severe periodontitis .
METHODS	From May 2009 to September 2011 , 52 patients who were diagnosed of severe periodontitis were involved in this study .
METHODS	They were randomly divided into 2 groups .
METHODS	Patients in group A were given periodontal-pulp combined therapy , while patients in group B were given periodontal therapy .
METHODS	SBI , PD , AL were recorded in baseline , 3 months , 6 months , 1 year and 2 years after treatment .
METHODS	Statistical analysis was performed with SPSS13 .0 software package .
RESULTS	All the indexes were different between 2 groups in baseline .
RESULTS	Three months after treatment , all the indexes were not significantly different between two groups .
RESULTS	Six months after treatment , SBI was significantly different between 2 groups , but PD and AL were not significantly different between 2 groups .
RESULTS	One year after treatment , all the indexes were significantly different between 2 groups .
RESULTS	Two years after treatment , SBI was not significantly different between 2 groups , but PD and AL were significantly different between two groups .
RESULTS	The results of periodontal-pulp combined therapy were better than periodontal therapy .
CONCLUSIONS	Periodontal-pulp combined therapy is necessary for patients with severe periodontitis .

###26027629
BACKGROUND	In the PLATO trial , ticagrelor was superior to clopidogrel in reducing cardiovascular events among patients with acute coronary syndrome ( ACS ) at the expense of increased nonfatal bleeding .
BACKGROUND	Because Asian patients , when compared with non-Asian patients , are believed to be more susceptible to bleeding , we evaluated the effects of ticagrelor compared with clopidogrel in Asian ( n = 1,106 ) and non-Asian ( n = 17,515 ) patients with acute coronary syndrome enrolled in the PLATO study .
RESULTS	Interaction between Asian/non-Asian and primary efficacy end point ( a composite of vascular death , myocardial infarction , and stroke ) and net clinical benefit ( composite of primary efficacy end point and coronary artery bypass graft [ CABG ] surgery or non-CABG-related major bleeding ) were evaluated with a Cox proportional hazards model .
RESULTS	Baseline demographics and comorbidities were different between Asians and non-Asians .
RESULTS	The overall cardiovascular event rates were higher in Asians , but bleeding rates were similar .
RESULTS	Despite these observed differences , the effects of ticagrelor versus clopidogrel were not significantly different between Asians and non-Asians with respect to the primary efficacy outcome ( hazard ratio for Asians vs non-Asians , 0.84 [ 95 % CI 0.61-1 .17 ] vs 0.85 [ 95 % CI 0.77-0 .93 ] , P = .974 ) , net clinical benefit ( 0.85 [ 95 % CI 0.65-1 .11 ] vs 0.93 [ 95 % CI 0.86-0 .99 ] , P = .521 ) , or individual efficacy end points .
RESULTS	There was no significant interaction for bleeding ( PLATO major bleeding , 1.02 [ 95 % CI 0.70-1 .49 ] vs 1.04 [ 95 % CI 0.95-1 .14 ] , P = .938 ) and other related adverse events with ticagrelor compared with clopidogrel between Asians and non-Asians .
CONCLUSIONS	We observed consistency of effects in Asian patients receiving ticagrelor and clopidogrel in the PLATO study .
CONCLUSIONS	The relatively modest number of Asian patients in this analysis supports further investigation of larger cohorts to confirm our observations .

###24585160
BACKGROUND	Increased elevation of the head of the bed is linked to a higher risk for sacral pressure ulcers .
BACKGROUND	A semirecumbent position of at least 30 is recommended for the prevention of ventilator-associated pneumonia in patients treated with mechanical ventilation .
BACKGROUND	Therefore , prevention of pressure ulcers and prevention of pneumonia seem to demand contradictory , possibly incompatible , positioning .
OBJECTIVE	To measure pressure at the interface between sacral skin and the supporting surface in healthy volunteers at different degrees of upright position with different types of mattresses .
METHODS	An open , prospective , randomized crossover trial was conducted with 20 healthy volunteers .
METHODS	Interface pressure was measured by using a pressure mapping device with the participant in a supine position at 0 , 10 , 30 , and 45 elevation and in the reverse Trendelenburg position at 10 and 30 .
METHODS	Four types of mattresses were examined : 2 different foam mattresses and 2 air suspension beds , 1 of the latter with low-air-loss technology .
RESULTS	Peak sacral interface pressures increased significantly only at 45 of backrest elevation ( P < .001 ) .
RESULTS	A mattress system with low-air-loss technology significantly reduced peak interface pressures at all angles ( P < .001 ) .
RESULTS	The reverse Trendelenburg position led to lower peak pressures for all positions ( P = .01 ) .
CONCLUSIONS	Backrest elevation up to 30 might be a compromise between the seemingly incompatible demands of skin integrity and the prevention of ventilator-associated pneumonia .
CONCLUSIONS	The reverse Trendelenburg position and a mattress system with low-air-loss technology could be additional useful tools to help prevent skin breakdown at the sacrum .

###25175787
BACKGROUND	Moderate-intensity exercise training improves skeletal muscle aerobic capacity and increased oxidative enzyme activity , as well as exercise tolerance in COPD patients .
METHODS	To investigate whether the home-based exercise training program can reduce inflammatory biomarkers in patients with COPD , twelve patients using mobile phone assistance and 14 with free walk were assessed by incremental shuttle walk test ( ISWT ) , spirometry , strength of limb muscles , and serum C-reactive protein ( CRP ) and inflammatory cytokines .
RESULTS	Patients in the mobile phone group improved their ISWT walking distance , with decrease in serum CRP after 2 months , and sustained at 6 months .
RESULTS	Patients in the control group had no improvement .
RESULTS	Serum IL-8 in the mobile phone group was significantly reduced at 2 , 3 and 6 months after doing home exercise training compared to baseline .
RESULTS	IL-6 and TNF - were significantly elevated at 3 and 6 months in control group , while there were no changes in mobile phone group .
RESULTS	The strength of limb muscles was significantly greater compared to baseline at 3 and 6 months in the mobile phone group .
CONCLUSIONS	A mobile-phone-based system can provide an efficient home endurance exercise training program with improved exercise capacity , strength of limb muscles and a decrease in serum CRP and IL-8 in COPD patients .
CONCLUSIONS	Decreased systemic inflammation may contribute to these clinical benefits .
CONCLUSIONS	( Clinical trial registration No. : NCT01631019 ) .

###24760536
OBJECTIVE	Recent studies have indicated that serum testosterone in aging men is associated with insulin sensitivity and expression of genes involved in oxidative phosphorylation ( OxPhos ) , and that testosterone treatment increases lipid oxidation .
OBJECTIVE	Herein , we investigated the effect of testosterone therapy on regulators of mitochondrial biogenesis and markers of OxPhos and lipid metabolism in the skeletal muscle of aging men with subnormal bioavailable testosterone levels .
METHODS	Skeletal muscle biopsies were obtained before and after treatment with either testosterone gel ( n = 12 ) or placebo ( n = 13 ) for 6 months .
METHODS	Insulin sensitivity and substrate oxidation were assessed by euglycemic-hyperinsulinemic clamp and indirect calorimetry .
METHODS	Muscle mRNA levels and protein abundance and phosphorylation of enzymes involved in mitochondrial biogenesis , OxPhos , and lipid metabolism were examined by quantitative real-time PCR and western blotting .
RESULTS	Despite an increase in lipid oxidation ( P < 0.05 ) , testosterone therapy had no effect on insulin sensitivity or mRNA levels of genes involved in mitochondrial biogenesis ( PPARGC1A , PRKAA2 , and PRKAG3 ) , OxPhos ( NDUFS1 , ETFA , SDHA , UQCRC1 , and COX5B ) , or lipid metabolism ( ACADVL , CD36 , CPT1B , HADH , and PDK4 ) .
RESULTS	Consistently , protein abundance of OxPhos subunits encoded by both nuclear ( SDHA and UQCRC1 ) and mitochondrial DNA ( ND6 ) and protein abundance and phosphorylation of AMP-activated protein kinase and p38 MAPK were unaffected by testosterone therapy .
CONCLUSIONS	The beneficial effect of testosterone treatment on lipid oxidation is not explained by increased abundance or phosphorylation-dependent activity of enzymes known to regulate mitochondrial biogenesis or markers of OxPhos and lipid metabolism in the skeletal muscle of aging men with subnormal bioavailable testosterone levels .

###24495792
OBJECTIVE	To explore synergistic effect between angiotensin II receptor blockers ( ARBs ) and statins on Th17/Treg functional imbalance in hypertensive patients with carotid atherosclerosis .
METHODS	This study was a 2 2 factorial randomized , prospective , double-blind , placebo-controlled trial .
METHODS	One hundred and fifty nine hypertensive patients with carotid atherosclerosis were randomized to the administration of control group , telmisartan group , rosuvastatin group , and combination group ( telmisartan plus rosuvastatin ) base on hydrochlorothiazide treatment .
METHODS	Carotid ultrasonography , parameters of Th17/Treg functional axis , interleukin ( IL ) -1 , IL-2 , interferon ( IFN ) - , hypersensitive C-reactive protein ( hsCRP ) , monocyte chemotactic protein ( MCP ) -1 were evaluated .
RESULTS	Blood pressure level markedly reduced in four groups .
RESULTS	There was significantly synergistic effect of combination of telmisartan with rosuvastatin on reducing carotid imtima-media thickness ( IMT ) , Th17 cells frequency , IL-17 , IL-6 , IL-23 , tumor necrosis factor ( TNF ) - , expression of retinoic acid receptor-related orphan receptor ( ROR ) t mRNA , Th17/Treg ratio , IL-1 , IL-2 , IFN - , hsCRP , and MCP-1 , and increasing Treg cells frequency , IL-10 , transforming growth factor ( TGF ) -1 , and expression of forkhead/winged helix transcription factor ( Foxp3 ) mRNA ( all P < 0.05 ) .
RESULTS	Change rate of IMT statistical positively related to descent rates of Th17 cells frequency , IL-17 , IL-6 , IL-23 , TNF - , expression of RORt mRNA , Th17/Treg ratio , IL-1 , IL-2 , IFN - , hsCRP , and MCP-1 , and negatively related to increased rates of Treg frequency , IL-10 , TGF-1 , and expression of Foxp3 mRNA , respectively ( all P < 0.05 ) .
CONCLUSIONS	There is a synergistic effect of combination of telmisartan with rosuvastatin on ameliorating Th17/Treg functional imbalance in hypertensive patients with carotid atherosclerosis .

###25104521
BACKGROUND	The RELAX ( Phosphodiesterase-5 Inhibition to Improve Clinical Status and Exercise Capacity in Heart Failure with Preserved Ejection Fraction ) study was a multicenter , randomized trial of sildenafil versus placebo in heart failure with preserved ejection fraction ( HFpEF ) with rigorous entry criteria and extensive phenotypic characterization of participants .
OBJECTIVE	The aim of this study was to characterize clinical features , exercise capacity , and outcomes in patients with HFpEF with or without diabetes and gain insight into contributing pathophysiological mechanisms .
METHODS	The RELAX study enrolled 216 stable outpatients with heart failure , an ejection fraction 50 % , increased natriuretic peptide or intracardiac pressures , and reduced exercise capacity .
METHODS	Prospectively collected data included echocardiography , cardiac magnetic resonance , a comprehensive biomarker panel , exercise testing , and clinical events over 6 months .
RESULTS	Compared with nondiabetic patients ( n = 123 ) , diabetic HFpEF patients ( n = 93 ) were younger , more obese , and more often male and had a higher prevalence of hypertension , renal dysfunction , pulmonary disease , and vascular disease ( p < 0.05 for all ) .
RESULTS	Uric acid , C-reactive protein , galectin-3 , carboxy-terminal telopeptide of collagen type I , and endothelin-1 levels were higher in diabetic patients ( p < 0.05 for all ) .
RESULTS	Diabetic patients had more ventricular hypertrophy , but systolic and diastolic ventricular function parameters were similar in diabetic and nondiabetic patients except for a trend toward higher filling pressures ( E/e ' ) in diabetic patients .
RESULTS	Diabetic patients had worse maximal ( peak oxygen uptake ) and submaximal ( 6-min walk distance ) exercise capacity ( p < 0.01 for both ) .
RESULTS	Diabetic patients were more likely to have been hospitalized for heart failure in the year before study entry ( 47 % vs. 28 % , p = 0.004 ) and had a higher incidence of cardiac or renal hospitalization at 6 months after enrollment ( 23.7 % vs. 4.9 % , p < 0.001 ) .
CONCLUSIONS	HFpEF patients with diabetes are at increased risk of hospitalization and have reduced exercise capacity .
CONCLUSIONS	Multimorbidity , impaired chronotropic reserve , left ventricular hypertrophy , and activation of inflammatory , pro-oxidative , vasoconstrictor , and profibrotic pathways may contribute to adverse outcomes in HFpEF patients with diabetes .
CONCLUSIONS	( Evaluating the Effectiveness of Sildenafil at Improving Health Outcomes and Exercise Ability in People With Diastolic Heart Failure [ The RELAX Study ] ; NCT00763867 ) .

###25493493
OBJECTIVE	To evaluate the contribution of auriculotherapy in smoking cessation .
METHODS	Double-blind randomized controlled trial , conducted with 30 smokers allocated into two groups : Experimental Group ( 21 participants received 10 sessions of auriculotherapy at specific points for smoking ) and Control Group ( nine participants received auriculotherapy in points that have no effect on the focus of research ) .
RESULTS	Auriculotherapy contributed in reducing the number of cigarettes smoked in 61.9 % of participants ( p = 0.002 ) , in reducing the difficult to abstain from smoking in places where it is forbidden by 38 % ( p = 0.050 ) and in not smoking when ill 23.8 % ( p = 0.025 ) .
CONCLUSIONS	Given the efficacy only in terms of reducing the number of cigarettes smoked and other parameters , we suggest that future studies consider the use of auriculotherapy combined with other treatment methods , in order to achieve better results in cessation/abstinence .

###24755007
OBJECTIVE	The Bleeding Academic Research Consortium ( BARC ) classification has been proposed by consensus to standardize bleeding endpoint definition and reporting in cardiovascular clinical trials .
OBJECTIVE	There are no prospective studies on its prognostic impact .
RESULTS	We explored the association of BARC-defined bleeding with mortality and compared its prognostic value against two validated bleeding scales : the Thrombolysis in Myocardial Infarction ( TIMI ) and the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries ( GUSTO ) scales .
RESULTS	Non-coronary artery bypass graft ( CABG ) - related bleedings within the PRODIGY trial were prospectively adjudicated by a blinded Clinical Event Committee and analysed according to multiple statistical modelling .
RESULTS	At 2 years , bleeding occurred in 143 patients ( 7.1 % ) according to BARC Type 2 , 3 , or 5 ; in 50 patients ( 2.5 % ) according to TIMI minor or major ; and in 61 patients ( 3.1 % ) according to GUSTO moderate or severe .
RESULTS	One hundred sixty-three patients died ( 8.1 % ) .
RESULTS	After multivariable modelling , BARC Type 2 , 3 , or 5 bleeding was associated with increased 2-year mortality [ hazard ratio ( HR ) : 3.77 ; 95 % confidence interval ( CI ) : 2.37-5 .98 ] .
RESULTS	Bleeding Academic Research Consortium Type 3 or 5 was associated with an increased mortality rate at 2 years ( adjusted HR : 7.72 ; 95 % CI : 4.75-12 .54 ) similar to that provided by TIMI ( HR : 7.64 , 95 % CI : 4.53-12 .87 ) or GUSTO ( HR : 7.36 , 95 % CI : 4.38-12 .34 ) criteria .
CONCLUSIONS	In a contemporary , all-comer percutaneous coronary intervention trial actionable BARC bleedings were associated with increased risk of mortality with BARC Type 3 or 5 bleedings providing a similar mortality risk to that posed by TIMI or GUSTO scales .

###25091716
BACKGROUND	Given the complexity of the health insurance market in the United States and the confusion that often stems from these complexities , patient perception about the value of health insurance in managing chronic disease is important to understand .
OBJECTIVE	To examine differences between public and private health insurance in perceptions of financial burden with managing asthma , outcomes , and factors that explain these perceptions .
METHODS	Secondary analysis was performed using baseline data from a randomized clinical trial that were collected through telephone interviews with 219 African American women seeking services for asthma and reporting perceptions of financial burden with asthma management .
METHODS	Path analysis with multigroup models and multiple variable regression analyses were used to examine associations .
RESULTS	For public ( P < .001 ) and private ( P < .01 ) coverage , being married and more educated were indirectly associated with greater perceptions of financial burden through different explanatory pathways .
RESULTS	When adjusted for multiple morbidities , asthma control , income , and out-of-pocket expenses , those with private insurance used fewer inpatient ( P < .05 ) and emergency department ( P < .001 ) services compared with those with public insurance .
RESULTS	When also adjusted for health insurance , greater financial burden was associated with more urgent office visits ( P < .001 ) and lower quality of life ( P < .001 ) .
CONCLUSIONS	African American women who perceive asthma as a financial burden regardless of health insurance report more urgent health care visits and lower quality of life .
CONCLUSIONS	Burden may be present despite having and being able to generate economic resources and health insurance .
CONCLUSIONS	Further policy efforts are indicated and special attention should focus on type of coverage .

###24334945
BACKGROUND	The development and spread of Plasmodium falciparum resistance to most commonly used antimalarials remain a major challenge in the control of malaria .
BACKGROUND	Constant monitoring of drug efficacy is an important tool in establishing rational antimalarial drug policies .
METHODS	A randomized comparative study was conducted at the Wesley Guild Hospital , Ilesa , Nigeria between February 2010 and September 2011 comparing the efficacy and safety of artemether-lumefantrine ( Coartem ) and fixed dose of artesunate plus amodiaquine ( Larimal ) in the treatment of uncomplicated P. falciparum malaria in children betweem 6 and 144 months of age .
METHODS	P. falciparum malaria parasitemia was assessed by microscopy and rapid diagnostic test .
METHODS	Drugs were administered according to age for three days under supervision .
METHODS	The primary efficacy endpoint was a day 28 PCR-corrected parasitological cure .
RESULTS	A total of 182 patients were enrolled in the two treatment groups , Coartem ( n = 101 ) and Larimal ( n = 81 ) , and tested after 28 days .
RESULTS	In the intention-to-treat population , Coartem ( n = 101 ) and Larimal ( n = 81 ) had a PCR-corrected cure rate of 98 % and 100 % respectively , while in the per-protocol population , Coartem ( n = 89 ) and Larimal ( n = 71 ) both had a PCR-corrected cure rate of 100 % at day 28 .
RESULTS	Although parasite and fever clearance time was faster in the Larimal group , no significant difference was observed between the two drugs .
RESULTS	No serious adverse effects were reported .
CONCLUSIONS	Five years after being introduced in Nigeria , both Coartem and Larimal have been shown to be safe and highly effective in the treatment of uncomplicated P. falciparum malaria in children .

###25454337
OBJECTIVE	This double-blind , sham-controlled trial investigated the effects of two daily tDCS sessions over a 5-day period in treatment-resistant depression .
METHODS	Twenty-four treatment-resistant depressed patients received two daily sessions of active or sham anodal tDCS to the left prefrontal cortex ( 2 mA , 10 sessions over 1 week ) .
METHODS	Depression severity , psychomotor retardation and cognitive function were assessed .
RESULTS	Active tDCS was not significantly superior to sham tDCS on the HDRS at week 4 , as well as on the MADRS and SRRS scales , and on neuropsychological tests .
RESULTS	Response rates were not significantly higher with active tDCS .
RESULTS	tDCS was well tolerated , with mild adverse events limited to transient scalp discomfort .
CONCLUSIONS	tDCS did not induce clinically relevant antidepressant effect in active and sham stimulation groups .
CONCLUSIONS	There was no impact on psychomotor and neuropsychological functioning .
CONCLUSIONS	tDCS efficacy on specific symptom profiles in pharmacotherapy-resistant depression is limited .
CONCLUSIONS	The use of optimized stimulation protocol and longer period of follow up may valuably contribute to specify the place of tDCS in treatment-resistant depression .

###24738117
OBJECTIVE	The aim of this study was to evaluate the role of suture closure of the subcutaneous tissue in preventing wound complications after cesarean section with a Pfannenstiel incision , and to investigate factors associated with wound complications .
METHODS	Patients undergoing cesarean delivery were randomly assigned to either suture closure or non-closure of the subcutaneous tissue .
METHODS	The participants were invited to two follow-up examinations at the 1st and 4th postoperative weeks for the detection of wound complications .
METHODS	The two main outcomes were composite wound complication and superficial wound separation .
METHODS	Factors associated with wound complications were analyzed using multiple logistic regression .
RESULTS	During the study period , a total of 361 patients ( 176 in the closure group , 185 in non-closure group ) were analyzed .
RESULTS	Composite wound complication occurred in 23.3 % ( 41/176 ) of the closure group , and in 20 % ( 37/185 ) of the non-closure group with no significant difference ( P = 0.44 ) .
RESULTS	Wound separation occurred in 2.3 % ( 4/176 ) of the closure group and 1.6 % ( 3/185 ) of the non-closure group without any significant differences ( P = 0.64 ) .
RESULTS	None of the factors were found to be associated with the rate of composite complication .
RESULTS	The significant factors found to be associated with wound separation were subcutaneous tissue thickness of 4cm or more ( P = 0.01 ) and maternal diabetes mellitus ( P = 0.01 ) , however they lost their significance in multivariate analyses .
CONCLUSIONS	The rate of wound complications , including superficial wound separation , did not differ according to the subcutaneous closure in cesarean delivery with Pfannenstiel incision .
CONCLUSIONS	It is not possible to predict wound complications using previously defined clinical and operative risk factors , including subcutaneous tissue thickness .

###24738786
OBJECTIVE	To determine the effectiveness of a novel sonic toothbrush in reducing plaque and in maintenance of gingival health when compared to a standard manual brush .
METHODS	This study was a block-randomized , examiner-blind , two-treatment , parallel group , single centre clinical investigation .
METHODS	A total of 84 subjects were enrolled and randomly assigned to receive either the Panasonic EW-DL90 or an American Dental Association-endorsed manual toothbrush .
METHODS	Subjects were instructed to follow a twice-daily brushing regimen without flossing .
METHODS	Plaque levels and gingival health were assessed at baseline and after 1 and 3 weeks of treatment using the Turesky Modification of the Quigley-Hein Plaque Index and the Papillary Bleeding Score .
RESULTS	Subjects assigned to the EW-DL90 group had significantly lower plaque levels after 1 and 3 weeks of treatment than those in the manual group ( P = 0.003 and 0.0035 , respectively ) .
RESULTS	Both groups showed a reduction in plaque levels at Week 3 relative to baseline .
RESULTS	The EW-DL90 group had significantly lower gingival inflammation scores after 1 week of treatment ( P = 0.0293 ) , but there was no difference between groups after 3 weeks of treatment .
CONCLUSIONS	The EW-DL90 toothbrush safely and effectively removes more plaque than a standard manual toothbrush .
CONCLUSIONS	Improvement in gingival inflammation was observed after 1 week of treatment .
CONCLUSIONS	There was no difference in Papillary Bleeding Score between the two groups after 3 weeks of treatment .
CONCLUSIONS	The newly developed sonic brush ( Panasonic EW-DL90 ) tested in this study was found to be more effective than a manual toothbrush at plaque removal .
CONCLUSIONS	The papillary bleeding scores were significantly lower in the sonic brush group after 1 week of product use .
CONCLUSIONS	After 3 weeks of product use , both treatment groups had similar papillary bleeding scores almost returning to baseline values .

###25637151
OBJECTIVE	This study aimed to assess the effectiveness of Benson 's relaxation technique in improving the hemodialysis patients ' dietary and fluid adherence and biomedical markers .
METHODS	This randomized controlled trial with a pre-post test design was conducted on 86 hemodialysis patients randomly divided into an intervention ( receiving Benson 's relaxation technique ) and a control group ( usual care ) .
METHODS	The setting of the study was two hemodialysis units affiliated to Shiraz University of Medical Sciences , Shiraz , Iran .
METHODS	The patients listened to the audiotape of Benson 's relaxation technique twice a day each time for 20min for 8 weeks .
METHODS	Dietary and fluid adherence and some biomedical markers were measured in both the intervention and the control group at baseline and at the 8th week after the intervention .
RESULTS	The results showed significant differences between the two groups regarding blood urea nitrogen and phosphate as dietary adherence and interdialytic weight gain as fluid adherence in the 8th week of the intervention ( P < 0.05 ) .
RESULTS	Also , a significant difference was found between the two groups concerning blood glucose level after the intervention ( P < 0.05 ) .
CONCLUSIONS	This study highlighted the importance of Benson 's relaxation technique in improvement of adherence and some biomedical markers in hemodialysis patients .
CONCLUSIONS	Thus , Benson 's relaxation therapy could be used as a part of the nursing care practice for hemodialysis patients and those suffering from chronic diseases .

###24379229
BACKGROUND	Early postnatal head growth failure is well recognized in very preterm infants ( VPIs ) .
BACKGROUND	This coincides with the characteristic nutritional deficits that occur in these parenteral nutrition ( PN ) dependent infants in the first month of life .
BACKGROUND	Head circumference ( HC ) is correlated with brain volume and later neurodevelopmental outcome .
BACKGROUND	We hypothesized that a Standardized , Concentrated With Added Macronutrients Parenteral ( SCAMP ) nutrition regimen would improve early head growth .
BACKGROUND	The aim was to compare the change in HC ( HC ) and HC SD score ( SDS ) achieved at day 28 in VPIs randomly assigned to receive SCAMP nutrition or a control standardized , concentrated PN regimen .
METHODS	Control PN ( 10 % glucose , 2.8 g/kg per day protein/lipid ) was started within 6 hours of birth .
METHODS	VPIs ( birth weight < 1200 g ; gestation < 29 weeks ) were randomly assigned to either start SCAMP ( 12 % glucose , 3.8 g/kg per day protein/lipid ) or remain on the control regimen .
METHODS	HC was measured weekly .
METHODS	Actual daily nutritional intake data were collected for days 1 to 28 .
RESULTS	There were no differences in demographic data between SCAMP ( n = 74 ) and control ( n = 76 ) groups .
RESULTS	Comparing cumulative 28-day intakes , the SCAMP group received 11 % more protein and 7 % more energy .
RESULTS	The SCAMP group had a greater HC at 28 days ( P < .001 ) .
RESULTS	The difference between the means ( 95 % confidence interval ) for HC was 5 mm ( 2 to 8 ) , and SDS was 0.37 ( 0.17 to 0.58 ) .
RESULTS	HC differences are still apparent at 36 weeks ' corrected gestational age .
CONCLUSIONS	Early postnatal head growth failure in VPIs can be ameliorated by optimizing PN .

###24742182
BACKGROUND	Chronic shoulder pain ( CSP ) is the third most common type of musculoskeletal pain .
BACKGROUND	It has a major impact on health-related quality of life .
BACKGROUND	In Chinese medicine , CSP is considered one of the conditions most amenable to treatment with acupuncture .
BACKGROUND	The purpose of this study is to evaluate the efficacy of local acupoints in combination with distal acupoints in pain relief and shoulder function improvement in CSP patients .
METHODS	This is a multicenter , single blind , factorial randomized controlled clinical trial .
METHODS	A total of 164 participants will be randomly allocated to four different groups : Group A will receive acupuncture at local acupoints in combination with distal acupoint .
METHODS	Group B will receive acupuncture at local acupoints in combination with distal non-acupoint .
METHODS	Group C will receive acupuncture at local non-acupoints in combination with distal acupoint .
METHODS	Group D will receive acupuncture at local non-acupoints in combination with distal non-acupoint .
METHODS	Each group will receive 12 treatments of acupuncture one to three times per week for six weeks in total .
METHODS	The primary outcome is shoulder pain intensity , which is graded using a 100 - mm Visual Analogue Scale .
METHODS	The assessment is at baseline ( before treatment initiation ) , 6weeks after the first acupuncture , 10weeks after the first acupuncture and 18weeks after the first acupuncture .
CONCLUSIONS	This trial will be helpful in identifying whether acupuncture at local acupoints in combination with distal acupoints may be more effective than needling points separately .
BACKGROUND	International Standard Randomized Controlled Trial Number Register : ISRCTN61861069 ( http://www.controlled-trials.com ) .

###25483215
BACKGROUND	Rivaroxaban is an oral , direct Factor Xa inhibitor , approved for the treatment of pulmonary embolism ( PE ) and deep vein thrombosis ( DVT ) and the secondary prevention of recurrent PE and DVT as a fixed-dose , monotherapy regimen that does not require initial heparinisation , routine coagulation monitoring or dose adjustment .
BACKGROUND	Approval in this indication was supported by results from EINSTEIN PE , a large , randomised , open-label study that compared rivaroxaban with enoxaparin/vitamin K antagonist ( VKA ) therapy in patients with acute symptomatic PE with or without DVT .
METHODS	Patient-reported treatment satisfaction was evaluated in a predefined subanalysis of EINSTEIN PE to enable monitoring and optimisation of patient-reported outcomes and , therefore , patient compliance .
METHODS	As part of EINSTEIN PE , 2,397 patients in seven countries were asked to complete a validated measure of treatment satisfaction , the Anti-Clot Treatment Scale ( ACTS ) throughout the duration of treatment ( up to 12 months ) .
RESULTS	Patients reported greater satisfaction in the rivaroxaban treatment arm as compared with the enoxaparin/VKA treatment arm .
RESULTS	Treatment with rivaroxaban was reported as being significantly less burdensome than enoxaparin/VKA therapy , and the benefits of treatment were significantly greater .
CONCLUSIONS	Rivaroxaban treatment resulted in improved treatment satisfaction compared with enoxaparin/VKA in PE patients , particularly in reducing patient-reported anticoagulation burden .

###25073663
OBJECTIVE	A sub-study to evaluate safety , tolerability , ease-of-use and patient satisfaction with a single-use autoinjector administering subcutaneous peginterferon-1a ( a pegylated interferon-1a in clinical development ) in a subset of relapsing-remitting multiple sclerosis ( MS ) patients participating in ATTAIN , a long-term dose-frequency blinded extension of the Phase III randomized ADVANCE study .
METHODS	Over 8 weeks , patients self-administered peginterferon-1a 125 g or placebo every 2 weeks ( two injections via manual pre-filled syringe [ PFS ] ; two injections via single-use autoinjector ) .
METHODS	Primary end points were incidence of adverse events ( AEs ) , patient assessment of injection pain score ( 10-point Visual Analog Scale ) , and clinician assessment of injection site reactions ( ISRs ) .
METHODS	Secondary objectives included patient assessment of ease-of-use and satisfaction with the autoinjector and evaluation of autoinjector training materials .
RESULTS	In 39 patients , the safety profile of peginterferon-1a was similar when delivered via autoinjector or PFS ; AEs were mostly mild or moderate in severity .
RESULTS	Clinicians and patients reported a similar tolerability profile using both PFS and autoinjector , and pain scores were low ( < 1 ) , with no reports of clinician-assessed ISRs after administration with the autoinjector .
RESULTS	Patients perceived the single-use autoinjector to be easy to use and convenient ; overall patient satisfaction with the autoinjector and accompanying training materials was high .
CONCLUSIONS	The safety and tolerability profile of peginterferon-1a delivered via autoinjector was similar to delivery via PFS .
CONCLUSIONS	Patients found the autoinjector easy to use and convenient ; this device may simplify the injection process for MS patients who require long-term therapy , thereby potentially improving patient 's quality of life and adherence .

###24661333
OBJECTIVE	To demonstrate the safety and efficacy of up to 5 years of degarelix treatment and the effects of crossing over from leuprolide to degarelix in the extension phase of a phase III pivotal 1-year trial .
METHODS	Patients receiving degarelix who completed the 1-year trial continued on 80 mg ( n = 125 ) or 160 mg ( n = 126 ) maintenance doses .
METHODS	Patients who received leuprolide were rerandomized to degarelix 240/80 mg ( n = 69 ) or 240/160 mg ( n = 65 ) .
METHODS	Safety and tolerability were assessed ( primary end point ) , as well as testosterone and prostate-specific antigen levels and prostate-specific antigen progression-free survival ( secondary end points ) .
RESULTS	Adverse event frequency was similar between both the groups .
RESULTS	Adverse events included initial injection site reactions , hot flushes , and increased weight .
RESULTS	Testosterone and prostate-specific antigen values during the extension study were similar to those seen during the 1-year trial in patients who continued on degarelix or crossed over from leuprolide .
RESULTS	The prostate-specific antigen progression-free survival hazard rate was decreased significantly after the crossover in the leuprolide to degarelix group ( from 0.20 to 0.09 ; P = .002 ) , whereas in patients who continued on degarelix , the rate did not change significantly .
RESULTS	In patients with baseline prostate-specific antigen > 20 ng/mL , the same hazard rate change pattern was observed on crossover ( from 0.38 to 0.19 ; P = .019 ) .
CONCLUSIONS	Degarelix was well tolerated ; no safety concerns were identified .
CONCLUSIONS	The significant prostate-specific antigen progression-free survival benefit established for degarelix over leuprolide during year 1 remained consistent at 5 years .

###24916419
OBJECTIVE	Oral biofilm formation and progression on the surface of the tooth can lead to advanced oral disease such as gingivitis .
OBJECTIVE	The purpose of this randomized , controlled , double-blinded study was to evaluate the effects of a novel dental gel on oral plaque biofilm using multimodal imaging techniques .
METHODS	Twenty-five subjects with moderate gingival inflammation ( Le and Silness Gingival Index 2 ) and pocket depths < 4 were randomly assigned to brush twice daily for 21 days with the test or the control dental gel .
METHODS	In vivo multimodality in situ imaging was performed over a 3-week period using in vivo Optical Coherence Tomography ( OCT ) and Non-Linear Optical microscopy ( NLOM ) .
METHODS	Plaque levels , gingival inflammation and gingival bleeding were also charted on days 0 , 7 , 14 , and 21 using standard clinical indices .
RESULTS	After 3 weeks , OCT and NLOM images showed a macroscopic break-up of the plaque layer and smaller , fragmented residual deposits in the test group with no apparent changes in the pellicle .
RESULTS	Biofilm was also reduced in the control group , but to a lesser degree with regard to thickness , continuity and surface area .
RESULTS	Paralleling these imaging results , clinical indices were significantly improved in both groups ( P < 0.05 ) and significantly lower in the test group ( P < 0.05 ) .
CONCLUSIONS	Both dental gels reduced oral biofilm with the test gel showing greater efficacy ( P < 0.05 ) as determined by clinical and imaging parameters .

###24420310
OBJECTIVE	This study examined the impact of pictorial cigarette-warning labels , warning-label message framing and plain cigarette packaging , on young adult smokers ' motivation to quit .
METHODS	Smokers aged 18-30 years ( n = 740 ) from a consumer research panel were randomised to one of four experimental conditions where they viewed online images of four cigarette packs with warnings about lung disease , cancer , stroke/heart disease and death , respectively .
METHODS	Packs differed across conditions by warning-message framing ( gain vs loss ) and packaging ( branded vs plain ) .
METHODS	Measures captured demographics , smoking behaviour , covariates and motivation to quit in response to cigarette packs .
RESULTS	Pictorial warnings about lung disease and cancer generated the strongest motivation to quit across conditions .
RESULTS	Adjusting for pretest motivation and covariates , a message framing by packaging interaction revealed gain-framed warnings on plain packs generated greater motivation to quit for lung disease , cancer and mortality warnings ( p < 0.05 ) , compared with loss-framed warnings on plain packs .
CONCLUSIONS	Warnings combining pictorial depictions of smoking-related health risks with text-based messages about how quitting reduces risks , may achieve better outcomes among young adults , especially in countries considering or implementing plain packaging regulations .

###24979518
OBJECTIVE	The aim of this study was to investigate the effects of CO2 insufflation on the pressure of the middle ear cavity ( PMEC ) during laparoscopic surgery under total intravenous anesthesia ( TIVA ) with propofol or sevoflurane as an inhalational anesthetic maintenance .
METHODS	Sixty patients who underwent laparoscopic/or non-laparoscopic surgery under general anesthesia were included in the study .
METHODS	For anesthetic maintenance with inhalation agents , 20 non-laparoscopic surgery patients in Group 1 were applied sevoflurane ( 2-2 .5 % ) .
METHODS	Forty patients who underwent laparoscopic surgery were randomized into two groups .
METHODS	Anesthesia was maintained with sevoflurane ( 2-2 .5 % ) in twenty patients in Group 2 and the TIVA technique in 20 patients in Group 3 .
METHODS	In Group 1 , PMEC was measured before anesthesia , 10 and 30 min after endotracheal intubation , 10 min before extubation , and 15 , 30 , 60 min and 6 hours in the postoperative period .
METHODS	In Group 2 and 3 , PMEC was measured before the anesthesia , 10 min after intubation , 10 and 30 min after CO2 insufflation , just before the CO2 elimination , 10 min before the extubation , and 15 , 30 , 60 min and 6 hours after extubation in the postoperative period .
RESULTS	PMEC was significantly increased in Group 1 at 10 min after intubation , at 30 min of the operation , before extubation , and at postoperative 15 and 30 min ( p < 0.05 ) .
RESULTS	In Group 3 , differences between PMECs were detected at the 30th min of insufflation ( p = 0.005 ) , and during elimination ( p = 0.035 ) compared to the initial measurement .
RESULTS	Generally , the values remained positive in Group 1 and negative in Group 3 .
RESULTS	There was a significant difference between Group 1 and Group 3 at 10 min after the induction ( p = 0.001 ) .
RESULTS	There was no statistically significant difference in PMECs between Group 2 and 3 patients undergoing laparoscopic surgery .
CONCLUSIONS	Our results indicate that , in laparoscopic surgery , TIVA used for the maintenance of anesthesia did not increase the PMEC and the changes caused by sevoflurane were also in the normal range of middle ear pressures .
CONCLUSIONS	In patients with previous ear surgery , if there is a need of classical surgical procedures in the future , sevoflurane anesthesia should not be the first choice due to its effects on PMEC , which cause it to be increased over 50 daPa , especially at 30 min after intubation .
CONCLUSIONS	Patient characteristics including previous ear surgery should be considered in selecting the optimum anesthetic agents and technique .

###25564143
OBJECTIVE	It has been suggested that statins have an effect on the modulation of the cytokine cascade and on the outcome of patients with community-acquired pneumonia ( CAP ) .
OBJECTIVE	The aim of this prospective , randomised , double-blind , placebo-controlled trial was to determine whether statin therapy given to hospitalised patients with CAP improves clinical outcomes and reduces the concentration of inflammatory cytokines .
METHODS	A tertiary teaching hospital in Barcelona , Spain .
METHODS	Thirty-four patients were randomly assigned and included in an intention-to-treat analysis ( 19 to the simvastatin group and 15 to the placebo group ) .
METHODS	Patients were randomly assigned to receive 20mg of simvastatin or placebo administered in the first 24h of hospital admission and once daily thereafter for 4days .
RESULTS	Primary end point was the time from hospital admission to clinical stability .
RESULTS	The secondary end points were serum concentrations of inflammatory cytokines and partial pressure of arterial oxygen/fractional inspired oxygen ( PaO2/FiO2 ) at 48h after treatment administration .
RESULTS	The trial was stopped because enrolment was much slower than originally anticipated .
RESULTS	The baseline characteristics of the patients and cytokine concentrations at the time of enrolment were similar in the two groups .
RESULTS	No significant differences in the time from hospital admission to clinical stability were found between study groups ( median 3days , IQR 2-5 vs 3days , IQR 2-5 ; p = 0.47 ) .
RESULTS	No significant differences in PaO2/FiO2 ( p = 0.37 ) , C reactive protein ( p = 0.23 ) , tumour necrosis factor - ( p = 0.58 ) , interleukin 6 ( IL-6 ; p = 0.64 ) , and IL-10 ( p = 0.61 ) levels at 48h of hospitalisation were found between simvastatin and placebo groups .
RESULTS	Similarly , transaminase and total creatine kinase levels were similar between study groups at 48h of hospitalisation ( p = 0.19 , 0.08 and 0.53 , respectively ) .
CONCLUSIONS	Our results suggest that the use of simvastatin , 20mg once daily for 4days , since hospital admission did not reduce the time to clinical stability and the levels of inflammatory cytokines in hospitalised patients with CAP .
BACKGROUND	ISRCTN91327214 .

###24491034
BACKGROUND	The emergence of HIV as a chronic condition means that people living with HIV are required to take more responsibility for the self-management of their condition , including making physical , emotional and social adjustments .
BACKGROUND	This paper describes the design and evaluation of Positive Outlook , an online program aiming to enhance the self-management skills of gay men living with HIV .
METHODS	This study is designed as a randomised controlled trial in which men living with HIV in Australia will be assigned to either an intervention group or usual care control group .
METHODS	The intervention group will participate in the online group program ` Positive Outlook ' .
METHODS	The program is based on self-efficacy theory and uses a self-management approach to enhance skills , confidence and abilities to manage the psychosocial issues associated with HIV in daily life .
METHODS	Participants will access the program for a minimum of 90 minutes per week over seven weeks .
METHODS	Primary outcomes are domain specific self-efficacy , HIV related quality of life , and outcomes of health education .
METHODS	Secondary outcomes include : depression , anxiety and stress ; general health and quality of life ; adjustment to HIV ; and social support .
METHODS	Data collection will take place at baseline , completion of the intervention ( or eight weeks post randomisation ) and at 12 week follow-up .
CONCLUSIONS	Results of the Positive Outlook study will provide information regarding the effectiveness of online group programs improving health related outcomes for men living with HIV .
BACKGROUND	ACTRN12612000642886 .

###24885976
BACKGROUND	Despite significant increases in global health investment and the availability of low-cost , efficacious interventions to prevent mother-to-child HIV transmission ( pMTCT ) in low - and middle-income countries with high HIV burden , the translation of scientific advances into effective delivery strategies has been slow , uneven and incomplete .
BACKGROUND	As a result , pediatric HIV infection remains largely uncontrolled .
BACKGROUND	A five-step , facility-level systems analysis and improvement intervention ( SAIA ) was designed to maximize effectiveness of pMTCT service provision by improving understanding of inefficiencies ( step one : cascade analysis ) , guiding identification and prioritization of low-cost workflow modifications ( step two : value stream mapping ) , and iteratively testing and redesigning these modifications ( steps three through five ) .
BACKGROUND	This protocol describes the SAIA intervention and methods to evaluate the intervention 's impact on reducing drop-offs along the pMTCT cascade .
METHODS	This study employs a two-arm , longitudinal cluster randomized trial design .
METHODS	The unit of randomization is the health facility .
METHODS	A total of 90 facilities were identified in Cte d'Ivoire , Kenya and Mozambique ( 30 per country ) .
METHODS	A subset was randomly selected and assigned to intervention and comparison arms , stratified by country and service volume , resulting in 18 intervention and 18 comparison facilities across all three countries , with six intervention and six comparison facilities per country .
METHODS	The SAIA intervention will be implemented for six months in the 18 intervention facilities .
METHODS	Primary trial outcomes are designed to assess improvements in the pMTCT service cascade , and include the percentage of pregnant women being tested for HIV at the first antenatal care visit , the percentage of HIV-infected pregnant women receiving adequate prophylaxis or combination antiretroviral therapy in pregnancy , and the percentage of newborns exposed to HIV in pregnancy receiving an HIV diagnosis eight weeks postpartum .
METHODS	The Consolidated Framework for Implementation Research ( CFIR ) will guide collection and analysis of qualitative data on implementation process .
CONCLUSIONS	This study is a pragmatic trial that has the potential benefit of improving maternal and infant outcomes by reducing drop-offs along the pMTCT cascade .
CONCLUSIONS	The SAIA intervention is designed to provide simple tools to guide decision-making for pMTCT program staff at the facility level , and to identify low cost , contextually appropriate pMTCT improvement strategies .
BACKGROUND	ClinicalTrials.gov NCT02023658 .

###24287124
OBJECTIVE	To assess the impact of a web-based intervention supplemented with text messages to reduce cancer risk linked with smoking , unhealthy diet , alcohol consumption , obesity , sedentary lifestyle and sun exposure .
METHODS	A total of 2001 voluntary adolescents from Spain and Mexico were recruited between 2009 and 2012 and randomly assigned to : one control group and two experimental groups , which received exclusively the online intervention ( experimental group 1 ) or the intervention supplemented with encouraging text messages ( experimental group 2 ) .
METHODS	The educational intervention was based on both : successful psychosocial models ( i.e. A.S.E. and Transtheoretical model ) and the school curriculum .
RESULTS	After a 9-month follow-up , the prevalence of students who did not eat fruit was reduced significantly in all groups : experimental group 1 ( -62.6 % ) , experimental group 2 ( -71.5 % ) and even the control group ( -66.8 % ) .
RESULTS	Being overweight was only reduced in the experimental group 2 ( -19.6 % ) .
RESULTS	The total cancer behavioral risk score , which ranged from 0 to 100 points ( highest risk ) , was significantly reduced in the experimental group 1 ( -3.5 points ) and in the experimental group 2 ( -5.3 points ) .
RESULTS	The text-supplemented online intervention increased the probability of improving the post-test total cancer behavioral risk ( OR = 1.62 ) .
CONCLUSIONS	The web-based intervention supplemented with text messages had a positive global impact , but it lead to only minimal changes in risky behaviors .
CONCLUSIONS	This intervention appears useful in controlling overweight adolescents .
BACKGROUND	ISRCTN27988779 .

###24773243
OBJECTIVE	To establish the efficacy of prophylactic nifedipine vs. placebo in reducing spontaneous preterm delivery in asymptomatic women at high risk for preterm delivery .
METHODS	Prospective multicentric randomized double-blind study .
METHODS	Tertiary care centre , University Hospitals of Brescia and Torino , Italy .
METHODS	Eighty-seven singleton pregnancies without uterine contractions and ultrasonographic cervical length of 25mm at 24-32weeks , at risk for preterm delivery , with longitudinal follow up in our Preterm Prevention Clinic .
METHODS	Selection was done on the basis of ultrasonographic cervical length ; 43 women were randomized to receive placebo and 44 to receive nifedipine .
METHODS	Primary end point : spontaneous preterm delivery < 37weeks in nifedipine vs. placebo .
RESULTS	delivery < 32weeks , maternal side effects , neonatal complications , admissions to the Neonatal Intensive Care Unit and randomization/delivery time in nifedipine vs. placebo .
RESULTS	There was no trend towards a lower risk of spontaneous preterm delivery , neither at < 37weeks of nifedipine vs. placebo ( 11.4 % vs. 19.0 % ; p = 0.320 ) , or < 32weeks ( 2.3 % vs. 2.4 % ; p = 0.973 ) .
RESULTS	Nifedipine reduced spontaneous preterm delivery < 37weeks ( p = 0.015 ) in the multiparous women by stratified analysis for parity .
RESULTS	SECONDARY OUTCOMES between the groups did not differ except for a higher percentage of maternal side-effects in the nifedipine group ( 31.8 % ) vs. placebo ( 11.9 % ) ( p < 0.05 ) .
RESULTS	Subgroup analysis showed a borderline ( p = 0.047 ) lower percentage of spontaneous preterm delivery in women with a ultrasonographic cervical length of < 20mm in the nifedipine group .
CONCLUSIONS	Prophylactic nifedipine in asymptomatic women at high risk for preterm delivery had a positive effect on the rate of spontaneous preterm delivery < 37weeks in multiparous women .

###25976743
BACKGROUND	We compared the activity of denosumab with zoledronic acid for delaying or preventing hypercalcaemia of malignancy ( HCM ) in patients with advanced cancer and bone metastases or with multiple myeloma .
METHODS	Patient-level data were combined from two identically designed , randomised , double-blind , active-controlled , phase III trials of advanced cancer patients with breast cancer and other solid tumours ( excluding breast or prostate cancer ) or multiple myeloma .
METHODS	End-points included time to first on-study HCM , time to first and subsequent on-study HCM , proportion of patients experiencing HCM and proportion of patients experiencing recurrent HCM .
RESULTS	Denosumab significantly delayed the time to first on-study HCM , representing a 37 % reduction in the hazard ratio ( HR ) compared with zoledronic acid ( HR , 0.63 ; 95 % confidence interval ( CI ) : 0.41-0 .98 ; P = 0.042 ) and reduced the risk of developing recurrent HCM ( time to first and subsequent on-study HCM ) by 52 % ( rate ratio , 0.48 ; 95 % CI : 0.29-0 .81 ; P = 0.006 ) .
RESULTS	The median time on study was 12.9 months .
RESULTS	Fewer patients receiving denosumab compared with zoledronic acid experienced an HCM event ( 1.7 % versus 2.7 % ; P = 0.028 ) .
RESULTS	Of the 84 patients experiencing an HCM event , 40 % of those receiving zoledronic acid experienced > 1 event of HCM compared with 31 % of those receiving denosumab .
CONCLUSIONS	Denosumab treatment was more efficacious than treatment with zoledronic acid in delaying or preventing HCM in advanced cancer patients with breast cancer , other solid tumours or multiple myeloma .

###24942631
BACKGROUND	Malignant pleural mesothelioma incidence continues to rise , with few available evidence-based therapeutic options .
BACKGROUND	Results of previous non-randomised studies suggested that video-assisted thoracoscopic partial pleurectomy ( VAT-PP ) might improve symptom control and survival .
BACKGROUND	We aimed to compare efficacy in terms of overall survival , and cost , of VAT-PP and talc pleurodesis in patients with malignant pleural mesothelioma .
METHODS	We undertook an open-label , parallel-group , randomised , controlled trial in patients aged 18 years or older with any subtype of confirmed or suspected mesothelioma with pleural effusion , recruited from 12 hospitals in the UK .
METHODS	Eligible patients were randomly assigned ( 1:1 ) to either VAT-PP or talc pleurodesis by computer-generated random numbers , stratified by European Organisation for Research and Treatment of Cancer risk category ( high vs low ) .
METHODS	The primary outcome was overall survival at 1 year , analysed by intention to treat ( all patients randomly assigned to a treatment group with a final diagnosis of mesothelioma ) .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00821860 .
RESULTS	Between Oct 24 , 2003 , and Jan 24 , 2012 , we randomly assigned 196 patients , of whom 175 ( 88 assigned to talc pleurodesis , 87 assigned to VAT-PP ) had confirmed mesothelioma .
RESULTS	Overall survival at 1 year was 52 % ( 95 % CI 41-62 ) in the VAT-PP group and 57 % ( 46-66 ) in the talc pleurodesis group ( hazard ratio 104 [ 95 % CI 076-142 ] ; p = 081 ) .
RESULTS	Surgical complications were significantly more common after VAT-PP than after talc pleurodesis , occurring in 24 ( 31 % ) of 78 patients who completed VAT-PP versus ten ( 14 % ) of 73 patients who completed talc pleurodesis ( p = 0019 ) , as were respiratory complications ( 19 [ 24 % ] vs 11 [ 15 % ] ; p = 022 ) and air-leak beyond 10 days ( five [ 6 % ] vs one [ 1 % ] ; p = 021 ) , although not significantly so .
RESULTS	Median hospital stay was longer at 7 days ( IQR 5-11 ) in patients who received VAT-PP compared with 3 days ( 2-5 ) for those who received talc pleurodesis ( p < 00001 ) .
CONCLUSIONS	VAT-PP is not recommended to improve overall survival in patients with pleural effusion due to malignant pleural mesothelioma , and talc pleurodesis might be preferable considering the fewer complications and shorter hospital stay associated with this treatment .
BACKGROUND	BUPA Foundation .

###24680843
OBJECTIVE	To compare the effects of 2 suturing techniques ( single versus double layer ) on healing of the uterine scar after a cesarean delivery .
METHODS	In the present randomized , prospective study , 36 women with a term pregnancy who had an elective cesarean delivery were randomly assigned to closure of the uterine incision with a single-layer locked suture or with a double-layer locked/unlocked suture .
METHODS	Six months after the operation , the integrity of the cesarean scar at the uterine incision site was assessed by hydrosonography .
METHODS	The healing ratio and the thickness of the residual myometrium covering the defect were calculated as markers of uterine scar healing .
RESULTS	There were no significant differences between the groups in terms of estimated blood loss , operation time , or additional hemostatic suture .
RESULTS	However , the mean thickness of the residual myometrium covering the defect was 9.95 1.94 mm after a double-layer closure and 7.53 2.54 mm after a single-layer closure ( P = 0.005 ) .
RESULTS	The mean healing ratio was significantly higher after a double-layer closure ( 0.83 0.10 ) than after a single-layer closure ( 0.67 0.15 ; P = 0.004 ) .
CONCLUSIONS	A double-layer locked/unlocked closure of the uterine incision at cesarean delivery decreases the risk of poor uterine scar healing .

###25118794
OBJECTIVE	To evaluate the feasibility and preliminary efficacy of a Web-based tobacco treatment for persons living with HIV ( PLWH ) .
METHODS	Prospective , randomized controlled trial .
METHODS	HIV-care center in the Bronx , New York .
METHODS	Eligibility criteria included HIV infection , current tobacco usage , interest in quitting , and access to a computer with internet .
METHODS	One hundred thirty-eight subjects enrolled , and 134 completed the study .
METHODS	Positively Smoke Free on the Web ( PSFW ) , an 8-session , 7-week targeted tobacco treatment program for PLWH , was compared with standard care ( brief advice to quit and self-help brochure ) .
METHODS	All subjects were offered nicotine patches .
METHODS	The main feasibility outcomes were number of sessions logged into , number of Web pages visited , number of interactive clicks , and total time logged in .
METHODS	The main efficacy outcome was biochemically verified , 7-day point prevalence abstinence 3 months after intervention .
RESULTS	PSFW subjects logged into a mean of 5.5 of 8 sessions and 26.2 of 41 pages .
RESULTS	They executed a mean of 10 interactive clicks during a mean total of 59.8 minutes logged in .
RESULTS	Most required reminder phone calls to complete the sessions .
RESULTS	Educational level , anxiety score , and home access of the Web site were associated with Web site usage .
RESULTS	Ten percent of the PSFW group vs. 4.3 % of controls achieved the abstinence end point .
RESULTS	Among those who completed all 8 sessions , 17.9 % were abstinent , and among women completers , 30.8 % were abstinent .
CONCLUSIONS	Web-based treatment is a feasible strategy for PLWH smokers , and preliminary findings suggest therapeutic efficacy .

###24657956
BACKGROUND	Some studies have shown the beneficial effects of yoga for individuals with bronchial hyperreactivity with regard to ( 1 ) a reduction in the use of rescue medication , ( 2 ) an increase in exercise capacity , and ( 3 ) an improvement in lung function .
BACKGROUND	Despite the fact that yoga is promising as a new treatment for pediatric patients , further studies are needed to assess the use of this training for asthma management .
OBJECTIVE	This study was performed to assess the beneficial effects of yoga in exercise-induced bronchoconstriction ( EIB ) in children .
METHODS	The study was prospective , with no control group .
METHODS	Participants were randomly chosen among the new patients at the unit .
METHODS	This study was conducted in the Erciyes University School of Medicine , Pediatric Allergy Unit , in Kayseri , Turkey .
METHODS	Two groups of asthmatic children aged 6-17 y were enrolled in the study : ( 1 ) children with positive responses to an exercise challenge ( n = 10 ) , and ( 2 ) those with negative responses ( n = 10 ) .
METHODS	Both groups attended 1-h sessions of yoga training 2 / wk for 3 mo. .
METHODS	Researchers administered spirometric measurement to all children before and immediately after participating in an exercise challenge .
METHODS	This process was performed at baseline and at the study 's end .
METHODS	Age , gender , IgE levels , eosinophil numbers , and spirometric measurement parameters including forced expiratory volume in 1 sec ( FEV1 ) , forced expiratory flow 25 % -75 % ( FEF25 % -75 % ) , forced vital capacity ( FVC ) , peak expiratory flow percentage ( PEF % ) , and peak expiratory flow rate ( PEFR ) were compared using the Mann-Whitney U test and the Wilcoxon test .
METHODS	A P value < .05 was considered significant .
RESULTS	At baseline , no significant differences were observed between the groups regarding demographics or pre-exercise spirometric measurements ( P > .05 , Mann-Whitney U test ) .
RESULTS	Likewise , no significant differences in spirometric measurements existed between the groups regarding the change in responses to an exercise challenge after yoga training ( P > .05 , Wilcoxon test ) .
RESULTS	For the exercise-response-positive group , the research team observed a significant improvement in maximum forced expiratory volume 1 % ( FEV1 % ) fall following the exercise challenge after yoga training ( P > .05 , Wilcoxon test ) .
RESULTS	All exercise-response-positive asthmatics became exerciseresponse-negative asthmatics after yoga training .
CONCLUSIONS	This study showed that training children in the practice of yoga had beneficial effects on EIB .
CONCLUSIONS	It is the research team 's opinion that yoga training can supplement drug therapy to achieve better control of asthma .

###25397691
OBJECTIVE	The aim of this study was to compare the recurrence of esophageal varices ( EVs ) after endoscopic band ligation ( EBL ) associated with propranolol ( PP ) versus EBL alone .
METHODS	Sixty-six cirrhotic outpatients ( EBL group , n = 32 and EBL+PP group , n = 34 ) with high-risk EVs without previous bleeding were studied .
METHODS	The primary outcome was recurrence of EV .
METHODS	The secondary outcomes were EV eradication , bleeding before EV eradication , mortality , and adverse events .
RESULTS	Demographic characteristics and the initial endoscopic findings were similar .
RESULTS	EV eradication was achieved in all patients .
RESULTS	Three patients presented gastrointestinal bleeding before variceal eradication , two in the EBL group and one in the EBL+PP group ( P = 0.13 ) .
RESULTS	Six patients died ( liver failure ) , two in the EBL group and four in the EBL+PP group ( P = 0.27 ) .
RESULTS	Twelve ( 38 % ) patients in the EBL group and three ( 9 % ) patients in the EBL+PP group had variceal recurrence .
RESULTS	The risk of recurrence of EVs after eradication was significantly higher among patients in the EBL group ( P = 0.003 ) .
CONCLUSIONS	EBL alone and EBL+PP were effective in the primary prophylaxis of bleeding from EVs in cirrhotic patients ( EV eradication , bleeding before EV eradication , mortality , and adverse events were similar in both groups ) .
CONCLUSIONS	However , variceal recurrence was lower in the EBL+PP group than band ligation alone .

###25212518
BACKGROUND	Fibromyalgia is a common chronic pain condition that has a significant impact on quality of life and often leads to disability .
BACKGROUND	To date , there have been few well-controlled trials assessing the utility of nonpharmacological treatment modalities such as transcutaneous electrical nerve stimulation ( TENS ) in the management of pain and improvement in function in individuals with fibromyalgia .
OBJECTIVE	The purpose of this study will be to complete a long-term , multicenter study to assess the effects of TENS in women with fibromyalgia .
METHODS	This will be a phase II randomized , double-blind , placebo-controlled , multicenter clinical trial .
METHODS	Three hundred forty-three participants with fibromyalgia will be recruited for this study .
METHODS	Participants will be randomly assigned to 1 of 3 groups : the intervention ( TENS ) , placebo , or no treatment .
METHODS	After completing the randomized period , all participants will receive the intervention for 1 month .
METHODS	The participants will be asked to use TENS at the highest tolerable level for at least 2 hours daily during physical activity .
METHODS	The primary outcome will be pain with movement , with secondary outcomes assessing functional abilities , patient-reported outcomes , and quantitative sensory testing .
CONCLUSIONS	Because having participants refrain from their typical medications is not practical , their usage and any change in medication use will be recorded .
CONCLUSIONS	The results of this study will provide some of the first evidence from a large-scale , double-blind , placebo-controlled trial on the effectiveness of TENS on pain control and quality-of-life changes in patients with fibromyalgia .

###25052850
BACKGROUND	In Sub-Saharan Africa over one million newborns die annually .
BACKGROUND	We developed a sustainable and scalable home-based counselling intervention for delivery by community volunteers in rural southern Tanzania to improve newborn care practices and survival .
BACKGROUND	Here we report the effect on newborn care practices one year after full implementation .
METHODS	All 132 wards in the 6-district study area were randomised to intervention or comparison groups .
METHODS	Starting in 2010 , in intervention areas trained volunteers made home visits during pregnancy and after childbirth to promote recommended newborn care practices including hygiene , breastfeeding and identification and extra care for low birth weight babies .
METHODS	In 2011 , in a representative sample of 5,240 households , we asked women who had given birth in the previous year both about counselling visits and their childbirth and newborn care practices .
RESULTS	Four of 14 newborn care practices were more commonly reported in intervention than comparison areas : delaying the baby 's first bath by at least six hours ( 81 % versus 68 % , OR 2.0 ( 95 % CI 1.2-3 .4 ) ) , exclusive breastfeeding in the three days after birth ( 83 % versus 71 % , OR 1.9 ( 95 % CI 1.3-2 .9 ) ) , putting nothing on the cord ( 87 % versus 70 % , OR 2.8 ( 95 % CI 1.7-4 .6 ) ) , and , for home births , tying the cord with a clean thread ( 69 % versus 39 % , OR 3.4 ( 95 % CI 1.5-7 .5 ) ) .
RESULTS	For other behaviours there was little evidence of differences in reported practices between intervention and comparison areas including childbirth in a health facility or with a skilled attendant , thermal care practices , breastfeeding within an hour of birth and , for home births , the birth attendant having clean hands , cutting the cord with a clean blade and birth preparedness activities .
CONCLUSIONS	A home-based counselling strategy using volunteers and designed for scale-up can improve newborn care behaviours in rural communities of southern Tanzania .
CONCLUSIONS	Further research is needed to evaluate if , and at what cost , these gains will lead to improved newborn survival .
BACKGROUND	Trial Registration Number NCT01022788 ( http://www.clinicaltrials.gov , 2009 ) .

###25213774
OBJECTIVE	To investigate the relationships between AMG 811 exposure , concentration changes in serum IFN - , and IFN -- induced protein 10 ( CXCL10 ) , and to identify important contributions of baseline covariates to these relationships .
METHODS	A mechanism based pharmacokinetic ( PK ) - pharmacodynamic ( PD ) model was developed .
METHODS	A target mediated disposition model was used to describe AMG 811 and target IFN - interaction .
METHODS	CXCL10 was predicted to be driven by estimated free IFN - levels .
RESULTS	For an average systemic lupus erythematosus ( SLE ) subject , the linear clearance ( CL ) of AMG 811 was 0.176 L/day , and the central ( Vc ) and peripheral ( Vp ) volumes of distribution were 1.48 and 2.12 L , respectively .
RESULTS	Body weight was found to correlate with CL , Vc , Vp , and inter compartment clearance ( Q ) ; and age was found to correlate with Vc .
RESULTS	The relationship between estimated free serum IFN - concentration levels and serum CXCL10 in logarithmic scales was best described by a linear model with slope and intercept estimated to be 0.197 and -0.3 , respectively .
CONCLUSIONS	The largest observed reduction of serum CXCL10 concentration was achieved at the highest AMG 811 dose tested ( 180 mg SC ) .
CONCLUSIONS	This model enables simulations of AMG 811 PK-PD profiles under various dosing regimens to support future clinical studies .

###25444953
OBJECTIVE	We evaluated whether stress levels in children and parents during radiological evaluation after febrile urinary tract infection are really lower using the top-down approach , where ( 99m ) technetium dimercaptosuccinic acid renal scintigraphy is used initially , than the bottom-up approach , where voiding cystourethrography is initially performed and repeated examinations are easier for all .
METHODS	We prospectively evaluated 120 children 3 to 8 years old .
METHODS	Pain ratings were obtained using the Faces Pain Scale-Revised , and conversation during the procedure was evaluated using the Child-Adult Medical Procedure Interaction Scale-Revised by 2 independent observers .
METHODS	To evaluate parental anxiety , the State-Trait Anxiety Inventory form was also completed .
METHODS	Following a documented febrile urinary tract infection children were randomized to the top-down or bottom-up group .
METHODS	A third group of 44 children undergoing repeat voiding cystourethrography and their parents were also evaluated .
RESULTS	Child ratings of pain using the Faces Pain Scale-Revised were not significantly different between the top-down group following ( 99m ) technetium dimercaptosuccinic acid renal scintigraphy ( 2.99 on a scale of 10 ) and the bottom-up group following voiding cystourethrography ( 3.21 ) .
RESULTS	Also the Faces Pain Scale-Revised was not significantly different in the repeat voiding cystourethrography group ( 3.35 ) .
RESULTS	On the Child-Adult Medical Procedure Interaction Scale-Revised there was negative correlation between child coping and child distress , as well as rate of child distress and adult coping promoting behavior .
RESULTS	Parental state anxiety scores were significantly less in the top-down and repeat voiding cystourethrography groups than in the bottom-up group .
CONCLUSIONS	Although the top-down approach and repeat voiding cystourethrography cause less anxiety for caregivers , these values do not correlate to pain scale in children .
CONCLUSIONS	This finding might be due to lack of appropriate evaluation tools of pediatric pain and anxiety .
CONCLUSIONS	However , the theory that the top-down approach is less invasive , and thus less stressful , requires further research .
CONCLUSIONS	The Child-Adult Medical Procedure Interaction Scale-Revised data indicate that influences in adult-child interaction are bidirectional .

###24720763
BACKGROUND	Atelectasis is common during and after general anaesthesia .
BACKGROUND	We hypothesized that a ventilation strategy with a combination of 1 ) continuous positive airway pressure ( CPAP ) or positive end-expiratory pressure ( PEEP ) and 2 ) a reduced end-expiratory oxygen concentration during recovery would reduce post-operative atelectasis .
METHODS	Sixty patients were randomized into two groups .
METHODS	During anaesthesia induction , inspiratory oxygen fraction ( FIO2 ) was 1.0 , and depending on weight , CPAP 6 , 7 or 8 cmH2O was applied in both groups via facemask .
METHODS	During maintenance of anaesthesia , a laryngeal mask airway ( LMA ) was used , and PEEP was 6-8 cmH2O in both groups .
METHODS	Before removal of the LMA , FIO2 was set to 0.3 in the intervention group and 1.0 in the control group .
METHODS	Atelectasis was studied by computed tomography ( CT ) approximately 14 min post-operatively .
RESULTS	In one patient in the group given an FIO2 of 0.3 before removal of the LMA a CT scan could not be performed so the patient was excluded .
RESULTS	The area of atelectasis was 5.5 , 0-16 .9 cm ( 2 ) ( median and range ) , and 6.8 , 0-27 .5 cm ( 2 ) in the groups given FIO2 0.3 or FIO2 1.0 before removal of the LMA , a difference that was not statistically significant ( P = 0.48 ) .
RESULTS	Post-hoc analysis showed dependence of atelectasis on smoking ( despite all were clinically lung healthy ) and American Society of Anesthesiologists class ( P = 0.038 and 0.015 , respectively ) .
CONCLUSIONS	Inducing anaesthesia with CPAP/PEEP and FIO2 1.0 and deliberately reducing FIO2 during recovery before removal of the LMA did not reduce post-operative atelectasis compared with FIO2 1.0 before removal of the LMA .

###24557087
OBJECTIVE	A classic general anesthesia is performed by induction with an intravenous hypnotic ( such as propofol ) and maintenance with a volatile anesthetic ( such as sevoflurane ) .
OBJECTIVE	The aim of the present study was to compare the effects of a propofol/sevoflurane maintenance regimen with that of a sevoflurane regimen on recovery profiles .
METHODS	One hundred and sixty patients , who were ASA 1 or 2 , 45-65 years of age , and scheduled for elective gastrointestinal surgery under combined general/epidural anesthesia , were allocated randomly to receive the sevoflurane maintenance regimen ( group S , n = 80 ) or sevoflurane/propofol regimen ( group SP , n = 80 ) .
METHODS	After induction , anesthesia was maintained with sevoflurane in group S and sevoflurane with propofol ( 1.2 g/ml target plasma concentration ) in group SP .
METHODS	Bispectral index ( BIS ) values were maintained within 40-60 during the maintenance .
METHODS	Time to extubation , incidence of serious coughing and agitation , and other recovery characteristics were evaluated during emergence .
RESULTS	The time to awakening and extubation in group SP were 7.2 2 min and 8.0 1.8 min , respectively , which were shorter than those results in group S ( 12.3 1.5 and 12.8 1.6 min , respectively ) ( P < 0.05 ) .
RESULTS	The incidence of serious coughing and agitation in SP ( 30 % and 25 % ) was lower than that of group S ( 68 % and 53 % ) ( P < 0.05 ) .
RESULTS	BIS value , pain score , requirements of analgesics and antiemetics in the PACU , and length of stay in the PACU were similar in the two groups .
CONCLUSIONS	Compared to sevoflurane maintenance , coadministration of propofol and sevoflurane provides faster awakening and extubation with a low incidence of emergence coughing and agitation .

###24595149
OBJECTIVE	To compare two intrathecal anaesthetics , bupivacaine and levobupivacaine , for their effects on motor and sensory blockade and haemodynamics in patients aged 65 years undergoing transurethral resection of the prostate ( TUR-P ) or transurethral resection of the urinary bladder ( TUR-M ) .
METHODS	Patients scheduled to undergo TUR-P or TUR-M were randomized to receive either 3 ml ( 15 mg ) 0.5 % isobaric levobupivacaine ( group L ) or 3 ml ( 15 mg ) of 0.5 % hyperbaric bupivacaine ( group B ) for spinal anaesthesia .
METHODS	The onset time , maximum level and time to reach the maximum level of sensory and motor blockade were recorded .
METHODS	Changes to haemodynamic parameters were also recorded .
RESULTS	The study randomized 100 patients : 57 to group L and 43 to group B. Levobupivacaine did not cause any significant changes in haemodynamic parameters , including systolic blood pressure , and showed a similar sensory block onset time compared with bupivacaine , but it had a significantly longer motor block onset time compared with bupivacaine .
CONCLUSIONS	These current findings suggest that levobupivacaine can be used as a substitute for bupivacaine for spinal anaesthesia in elderly patients 65 years of age undergoing elective TUR-P or TUR-M operations .

###25451179
BACKGROUND	Breast reconstruction aims to improve health-related quality of life after mastectomy .
BACKGROUND	However , evidence guiding patients and surgeons in shared decision-making concerning the optimal type or timing of surgery is lacking .
METHODS	QUEST comprised two parallel feasibility phase III randomized multicentre trials to assess the impact of the type and timing of latissimus dorsi breast reconstruction on health-related quality of life when postmastectomy radiotherapy is unlikely ( QUEST A ) or highly probable ( QUEST B ) .
METHODS	The primary endpoint for the feasibility phase was the proportion of women who accepted randomization , and it would be considered feasible if patient acceptability rates exceeded 25 per cent of women approached .
METHODS	A companion QUEST Perspectives Study ( QPS ) of patients ( both accepting and declining trial participation ) and healthcare professionals assessed trial acceptability .
RESULTS	The QUEST trials opened in 15 UK centres .
RESULTS	After 18 months of recruitment , 17 patients were randomized to QUEST A and eight to QUEST B , with overall acceptance rates of 19 per cent ( 17 of 88 ) and 22 per cent ( 8 of 36 ) respectively .
RESULTS	The QPS recruited 56 patients and 51 healthcare professionals .
RESULTS	Patient preference was the predominant reason for declining trial entry , given by 47 ( 53 per cent ) of the 88 patients approached for QUEST A and 22 ( 61 per cent ) of the 36 approached for QUEST B. Both trials closed to recruitment in December 2012 , acknowledging the challenges of achieving satisfactory patient accrual .
CONCLUSIONS	Despite extensive efforts to overcome recruitment barriers , it was not feasible to reach timely recruitment targets within a feasibility study .
CONCLUSIONS	Patient preferences for breast reconstruction types and timings were common , rendering patients unwilling to enter the trial .

###24469161
BACKGROUND	The depressor septi nasi muscle is responsible for smiling deformity .
BACKGROUND	Its manipulation is beneficial in patients with muscle hypertrophy .
BACKGROUND	In addition , it enhances the smile and tip-lip relationship .
BACKGROUND	In this study , depressor septi nasi muscle excision through a transfixion incision is compared with its transposition through an upper labial sulcus incision .
METHODS	Two techniques of depressor septi nasi muscle treatment were performed randomly for rhinoplasty cases .
METHODS	Smile analysis in rhinoplasty , consisting of measurements of nasal length , nasal diagonal , tip projection , and upper lip height , and noting transverse upper labial crease in repose and full smile , was performed on preoperative and postoperative photographs .
RESULTS	One hundred patients were studied in two equal groups .
RESULTS	Preoperatively , tip projection and upper lip height were decreased significantly with smiling .
RESULTS	Generally , the effect of smiling on all five parameters was decreased significantly following rhinoplasty .
RESULTS	The two different techniques were not significantly different in decreasing the effects of smiling on nasal length , nasal diagonal , tip projection , upper lip height , or transverse crease .
CONCLUSIONS	The two different techniques were the same in decreasing the effects of smiling .
CONCLUSIONS	The authors recommend smile analysis in rhinoplasty , consisting of measurement of nasal length , nasal diagonal , tip projection , and upper lip height , and noting transverse upper labial crease in repose and during smiling , before rhinoplasty for preoperative evaluation and after the operation for outcome assessment .
CONCLUSIONS	Depressor septi nasi muscle treatment should be considered if a decrease in tip projection or upper lip height with smiling or a transverse upper labial crease during smiling is extraordinary or unsightly .
METHODS	Therapeutic , II .

###24803495
BACKGROUND	Somatosensory stimulation ( SS ) is a potential adjuvant to stroke rehabilitation , but the effect on function needs further investigation .
OBJECTIVE	To explore the effect of combining SS with task-specific training ( TST ) on upper limb function and arm use in chronic stroke survivors and determine underlying mechanisms .
METHODS	In this double-blinded randomized controlled trial ( ISRCTN 05542931 ) , 33 patients ( mean 37.7 months poststroke ) were block randomized to 2 groups : active or sham SS .
METHODS	They received 12 sessions of 2 hours of SS ( active or sham ) to all 3 upper limb nerves immediately before 30 minutes of TST .
METHODS	The primary outcome was the Action Research Arm Test ( ARAT ) score .
METHODS	Secondary outcomes were time to perform the ARAT , Fugl-Meyer Assessment score ( FM ) , Motor Activity Log ( MAL ) , and Goal Attainment Scale ( GAS ) .
METHODS	Underlying mechanisms were explored using transcranial magnetic stimulation stimulus-response curves and intracortical inhibition .
METHODS	Outcomes were assessed at baseline , immediately following the intervention ( mean 2 days ) , and 3 and 6 months ( mean 96 and 190 days ) after the intervention .
RESULTS	The active group ( n = 16 ) demonstrated greater improvement in ARAT score and time immediately postintervention ( between-group difference ; P < .05 ) , but not at 3 - or 6-month follow-ups ( P > .2 ) .
RESULTS	Within-group improvements were seen for both groups for ARAT and GAS , but for the active group only for FM and MAL ( P < .05 ) .
RESULTS	Corticospinal excitability did not change .
CONCLUSIONS	Long-lasting improvements in upper limb function were observed following TST .
CONCLUSIONS	Additional benefit of SS was seen immediately post treatment , but did not persist and the underlying mechanisms remain unclear .

###24937546
BACKGROUND	There is current interest in the maternal-fetal effects of antenatal vitamin D supplementation , yet little data regarding vitamin D 's role in neonatal calcium homeostasis .
BACKGROUND	We determined to assess the effect of high-dose antenatal vitamin D supplementation on fetal and neonatal calcium concentrations .
METHODS	In a double-blinded , placebo-controlled trial in Bangladesh , 160 pregnant women were randomized to oral vitamin D3 ( 35,000 IU/wk ) or placebo from 26 to 29wk of gestation .
RESULTS	Total serum calcium ( Ca ) was higher in cord blood of those supplemented vs. placebo ( 2.660.1 vs. 2.610.2 mmol/l ; P = 0.04 ) , but the difference in albumin-adjusted calcium was not statistically significant .
RESULTS	Change in Ca concentration from birth to day 3 of life was attenuated by vitamin D ( -0.100.17 ) compared with placebo ( -0.220.18 mmol/l ; P = 0.02 ) .
RESULTS	Maternal 25-hydroxyvitamin D ( 25 ( OH ) D ) ( P = 0.04 ) and cord 25 ( OH ) D ( P < 0.01 ) were associated with day 3 infant Ca , suggesting that the effect of supplementation was mediated by change in maternal-infant vitamin D status .
RESULTS	Six infants in each of the supplemented and placebo groups had transient hypercalcemia/hypercalcuria ; in all the hypercalcemia/hypercalcuria was asymptomatic , spontaneously resolved , and unassociated with nephrocalcinosis at 1 mo of life .
CONCLUSIONS	High-dose antenatal third-trimester vitamin D supplementation attenuated the early postnatal calcium nadir , without increasing the risk of postnatal hypercalcemia .

###24661355
BACKGROUND	Patients on chronic dialysis are at increased risk of vitamin D deficiency .
BACKGROUND	In observational studies plasma 25-hydroxyvitamin D ( p-25 ( OH ) D ) levels are inversely correlated with plasma BNP and adverse cardiovascular outcomes .
BACKGROUND	Whether a causal relation exists has yet to be established .
BACKGROUND	The aim of this study was to test the hypothesis that cholecalciferol supplementation improves cardiac function and reduces blood pressure ( BP ) and pulse wave velocity ( PWV ) in patients on chronic dialysis .
METHODS	In a randomized , placebo-controlled , double-blind study , we investigated the effect of 75 g ( 3000 IU ) cholecalciferol daily for 6 months , in patients on chronic dialysis .
METHODS	We performed two-dimensional echocardiography , with doppler and tissue-doppler imaging , 24-h ambulatory BP ( 24-h BP ) , PWV , augmentation index ( AIx ) , central BP ( cBP ) and brain natriuretic peptide ( BNP ) measurements at baseline and after 6 months .
RESULTS	Sixty-four patients were allocated to the study .
RESULTS	Fifty dialysis patients with a mean age of 68 years ( range : 46-88 ) and baseline p-25 ( OH ) D of 28 ( 20 ; 53 ) nmol/l completed the trial .
RESULTS	Cholecalciferol increased left ventricular ( LV ) volume , but had no impact on other parameters regarding LV structure or left atrial structure .
RESULTS	LV systolic function , LV diastolic function , PWV , cBP , AIx and BNP were not changed in placebo or cholecalciferol group at follow-up .
RESULTS	24-h BP decreased significantly in placebo group and tended to decrease in cholecalciferol group without any difference between treatments .
CONCLUSIONS	Six months of cholecalciferol treatment in patients on chronic dialysis did not improve 24-h BP , arterial stiffness or cardiac function .
BACKGROUND	NCT01312714 , Registration Date : March 9 , 2011 .

###25017534
BACKGROUND	Excessive use of short-acting 2-agonists ( SABA ) indicates impaired asthma control .
OBJECTIVE	To determine whether real-time outreach to excessive SABA users reduces SABA canister dispensings .
METHODS	After real-time determination of a seventh SABA canister dispensing in the prior 12 months by using informational pharmacy technology , 12 to 56 year old patients with physician-coded asthma and inhaled corticosteroid dispensing were block randomized by prior asthma specialist care and medication step-care level into intervention ( n = 1001 ) and control groups ( n = 998 ) .
METHODS	Intervention included real-time letter notification to patients and an electronic message to their physician with management suggestions , including facilitated allergy referral for patients without prior asthma specialist care .
METHODS	The control group received this organization 's standard asthma care management without research contact .
METHODS	Frequency of the seventh SABA canister dispensing in the follow-up year was the primary outcome .
RESULTS	Compared with controls , intervention patients reached 7 SABA canister dispensings less frequently ( 50.7 % vs 57.1 % ; risk ratio 0.89 [ 95 % CI , 0.82-0 .97 ] ; P = .007 ) and later ( hazard ratio 0.80 [ 95 % CI , 0.71-0 .91 ; P < .001 ) .
RESULTS	SABA canister dispensings ( mean SD ) were less in intervention ( 7.5 4.9 canisters ) than controls ( 8.6 5.3 canisters ) ( rate ratio 0.87 [ 95 % CI , 0.82-0 .93 ] ; P < .001 ) .
RESULTS	The intervention reduced the risk of 7 SABA canister dispensings in patients without specialist care compared with patients with specialist care in the prior 3 years ( P < .001 ) ( P = .04 for interaction by prior specialist care ) .
RESULTS	Visits to allergists were more frequent for intervention patients ( 30.9 % ) than for control patients ( 16.8 % ) ( risk ratio 1.83 [ 95 % CI , 1.54-2 .16 ] ; P < .001 ) .
RESULTS	Asthma exacerbations were unaffected .
CONCLUSIONS	A novel administrative-based asthma outreach program improves markers of asthma impairment in patients without prior asthma specialist care and is adaptable to managed care organizations with electronic medical records .

###25153249
OBJECTIVE	To minimize stent-related symptoms , the proximal part of the Polaris stent is composed of a firm material and its distal part is composed of a soft material .
OBJECTIVE	The aim of this study was to compare stent-related symptoms of Polaris and Percuflex stents and to assess the impacts of these stents on quality of life .
METHODS	A total of 144 patients were randomized to a `` test '' group ( Polaris ; n = 64 ) or a `` conventional '' group ( Percuflex ; n = 80 ) at the time of ureteral stent insertion after ureteroscopic stone removal surgery .
METHODS	Stents were allocated using a randomization program .
METHODS	At 1 week postoperatively , patient symptoms were evaluated using the Ureteral Stent Symptom Questionnaire ( USSQ ) , and patients were asked complete a 10cm visual analogue scale ( VAS ) .
METHODS	Mean scores for USSQ domains and mean VAS scores were compared .
RESULTS	Mean patient age was 50.3 years , and the male-to-female ratio was 1:0.85 .
RESULTS	No significant intergroup differences were found in the domain scores of urinary symptoms ( P = 0.58 ) , pain ( P = 0.87 ) , general health ( P = 0.20 ) , work ( P = 0.24 ) , sexual activity ( P = 0.64 ) , or additional problems ( P = 0.24 ) .
RESULTS	In addition , VAS scores were nonsignificantly different ( P = 0.11 ) .
RESULTS	Analysis of USSQ item scores , however , revealed the test group had better results for `` presence of pain , '' `` frequency of pain killer use , '' `` difficulties with respect to hard physical activity , '' `` fatigue , '' `` frequency of rest , '' `` stent-related impact on work , '' `` antibiotics use '' than the conventional group except for `` outpatient department visits '' .
CONCLUSIONS	Compared with the conventional Percuflex ureteral stent , the new Polaris ureteral stent with a soft tail was not found to offer significant advantages in terms of voiding symptoms , pain , general health , sexual matters , or additional problems as determined by the USSQ or in VAS determined pain .
CONCLUSIONS	Sub-analysis , however , showed that the Polaris has some advantages with respect to pain , physical activities , impact on work , and additional problems .
CONCLUSIONS	Accordingly , the soft-tipped Polaris stent was found to have some clinical advantages over the conventional Percuflex stent .

###25004335
OBJECTIVE	To evaluate sexual function in midlife women taking low-dose oral estradiol or venlafaxine for hot flushes .
METHODS	In an 8-week randomized controlled trial among women aged 40-62 years , sexual function was compared between 0.5 mg oral estradiol per day or 75 mg venlafaxine per day ( both compared with a placebo ) .
METHODS	Measures included composite and six domain scores from the Female Sexual Function Index and sexually related personal distress .
RESULTS	Participants were aged 54.6 years ( standard deviation [ SD ] 3.8 ) years , 59 % white , with 8.1 ( SD 5.3 ) daily hot flushes .
RESULTS	Median composite baseline Female Sexual Function Index score was 16.3 ( SD 11.9 , n = 256 ) for all women and 21.7 ( SD 9.3 , n = 198 ) among sexually active women .
RESULTS	Composite mean Female Sexual Function Index change from baseline to week 8 was 1.4 ( 95 % confidence interval [ CI ] -0.4 to 3.2 ) for estradiol , 1.1 ( 95 % CI -0.5 to 2.7 ) for venlafaxine , and -0.3 ( 95 % CI -1.6 to 1.0 ) for placebo .
RESULTS	Composite Female Sexual Function Index and sexually related distress change from baseline did not differ between estradiol and placebo ( P = .38 , P = .30 ) or venlafaxine and placebo ( P = .79 , P = .48 ) .
RESULTS	Among sexually active women , Female Sexual Function Index domain score change from baseline differences ( active compared with placebo ) in desire was 0.3 ( 95 % CI 0.0-0 .6 ) for estradiol , -0.6 ( 95 % CI -1.2 to 0.0 ) in orgasm for venlafaxine , and 0.9 ( 95 % CI 0.2-1 .6 ) in penetration pain for venlafaxine .
RESULTS	No women reported adverse events related to sexual dysfunction .
CONCLUSIONS	Overall sexual function among nondepressed midlife women experiencing hot flushes did not change over 8 weeks with low-dose oral estradiol or venlafaxine ( compared with placebo ) , although a subtle increase in desire ( estradiol ) and decreases in orgasm and pain ( venlafaxine ) may exist .
BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT01418209 .
METHODS	I.

###25416557
BACKGROUND	Maternal depression carries a major public health burden for mothers and their infants , yet there is a substantial treatment gap for this condition in low-resourced regions such as sub-Saharan Africa .
BACKGROUND	To address this treatment gap , the strategy of `` task sharing '' has been proposed , involving the delivery of interventions by non-specialist health workers trained and supervised by specialists in routine healthcare delivery systems .
BACKGROUND	Several psychological interventions have shown benefit in treating maternal depression , but few have been rigorously evaluated using a task sharing approach .
BACKGROUND	The proposed trial will be the first randomised controlled trial ( RCT ) evaluating a task sharing model of delivering care for women with maternal depression in sub-Saharan Africa .
BACKGROUND	The objective of this RCT is to determine the effectiveness and cost-effectiveness of a task sharing counseling intervention for maternal depression in South Africa .
METHODS	The study is an individual-level two-arm RCT .
METHODS	A total of 420 depressed pregnant women will be recruited from two ante-natal clinics in a low-income township area of Cape Town , using the Edinburgh Postnatal Depression Scale to screen for depression ; 210 women will be randomly allocated to each of the intervention and control arms .
METHODS	The intervention group will be given six sessions of basic counseling over a period of 3 to 4 months , provided by trained community health workers ( CHW ) s.
METHODS	The control group will receive three monthly phone calls from a CHW trained to conduct phone calls but not basic counseling .
METHODS	The primary outcome measure is the 17-Item Hamilton Depression Rating Scale ( HDRS-17 ) .
METHODS	The outcome measures will be applied at the baseline assessment , and at three follow-up points : 1 month before delivery , and 3 and 12 months after delivery .
METHODS	The primary analysis will be by intention-to-treat and secondary analyses will be on a per protocol population .
METHODS	The primary outcome measure will be analyzed using linear regression adjusting for baseline symptom severity measured using the HDRS-17 .
CONCLUSIONS	The findings of this trial can provide policy makers with evidence regarding the effectiveness and cost-effectiveness of structured psychological interventions for maternal depression delivered by appropriately trained and supervised non-specialist CHWs in sub-Saharan Africa .
BACKGROUND	Clinical Trials ( ClinicalTrials.gov ) : NCT01977326 , registered on 24/10/2013 ; Pan African Clinical Trials Registry ( http://www.pactr.org ) : PACTR201403000676264 , registered on 11/10/2013 .

###24767265
OBJECTIVE	We aimed to explore the specific effects of mindfulness-based stress reduction ( MBSR ) for urban youth by comparing it with an active control program , designed to control for time , positive peer-group experience , and positive adult instructor .
METHODS	Patients between the ages of 13-21 years who received primary pediatric care at our urban outpatient clinic were eligible for study participation .
METHODS	Those who were interested were consented and randomly assigned to an eight-week program of MBSR or Healthy Topics ( HT ) , a health education curriculum .
METHODS	To increase sensitivity to outcomes of interest , mixed methods were used to assess psychological symptoms , coping , and program experience .
METHODS	Analysis of variance and regression modeling were used ; interviews were audio-taped , transcribed , and coded for key themes .
RESULTS	A total of 43 ( 26 MBSR , 17 HT ) youths attended one or more sessions , of whom 35 [ 20 MBSR ( 77 % ) , 15 HT ( 88 % ) ] attended the majority of the sessions and were considered completers .
RESULTS	Program completers were African American , 80 % female , with average age of 15.0 years .
RESULTS	Statistical analysis of survey data did not identify significant post-program differences between groups .
RESULTS	Qualitative data show comparable positive experiences in both programs , but specific differences related to MBSR participants use of mindfulness techniques to calm down and avoid conflicts , as well as descriptions of internal processes and self-regulation .
CONCLUSIONS	Compared with an active control program , MBSR did not result in statistically significant differences in self-reported survey outcomes of interest but was associated with qualitative outcomes of increased calm , conflict avoidance , self-awareness , and self-regulation for urban youths .
CONCLUSIONS	Importantly , based on qualitative results , the HT program functioned as an effective active control for MBSR in this sample , facilitating a more rigorous methodological approach to MBSR research in this population .
CONCLUSIONS	We believe the promising effects elucidated in the qualitative data have the potential for positive affective and behavioral outcomes .

###24568224
BACKGROUND	Plyometric exercise has been recommended to prevent lower limb injury , but its feasibility in and effects on those with functional ankle instability ( FAI ) are unclear .
OBJECTIVE	To investigate the effect of integrated plyometric and balance training in participants with FAI during a single-legged drop landing and single-legged standing position .
METHODS	Randomized controlled clinical trial .
METHODS	University motion-analysis laboratory .
METHODS	Thirty athletes with FAI were divided into 3 groups : plyometric group ( 8 men , 2 women , age = 23.20 2.82 years ; 10 unstable ankles ) , plyometric-balance ( integrated ) - training group ( 8 men , 2 women , age = 23.80 4.13 years ; 10 unstable ankles ) , and control group ( 7 men , 3 women , age = 23.50 3.00 years ; 10 unstable ankles ) .
METHODS	A 6-week plyometric-training program versus a 6-week integrated-training program .
METHODS	Postural sway during single-legged standing with eyes open and closed was measured before and after training .
METHODS	Kinematic data were recorded during medial and lateral single-legged drop landings after a 5-second single-legged stance .
RESULTS	Reduced postural sway in the medial-lateral direction and reduced sway area occurred in the plyometric - and integrated-training groups .
RESULTS	Generally , the plyometric training and integrated training increased the maximum angles at the hip and knee in the sagittal plane , reduced the maximum angles at the hip and ankle in the frontal and transverse planes in the lateral drop landing , and reduced the time to stabilization for knee flexion in the medial drop landing .
CONCLUSIONS	After 6 weeks of plyometric training or integrated training , individuals with FAI used a softer landing strategy during drop landings and decreased their postural sway during the single-legged stance .
CONCLUSIONS	Plyometric training improved static and dynamic postural control and should be incorporated into rehabilitation programs for those with FAI .

###25491514
BACKGROUND	The lack of national oral health policy and organized school dental health programs in the country call for affordable , accessible , and sustainable strategies .
OBJECTIVE	The objective was to compare the oral hygiene , plaque , gingival , and dental caries status among rural children receiving dental health education by qualified dentists and school teachers with and without supply of oral hygiene aids .
METHODS	This interventional study was conducted among 15-year-old children selected randomly from four schools in Nalgonda district between September 2009 and February 2010 .
METHODS	Schools were divided into four different intervention groups .
METHODS	The intervention groups varied in the form of intervention provider and frequency of intervention one of which being the control group .
METHODS	The oral hygiene , plaque , gingival , and dental caries status was assessed at baseline and 6 months following the intervention .
METHODS	SPSS 16 was used for analysis .
RESULTS	The preintervention and postintervention comparison within each group revealed a substantial reduction in mean oral hygiene index-simplified ( OHI-S ) , plaque index ( PI ) , and gingival index ( GI ) at postintervention compared to baseline in group 4 ( 1.26 , 0.87 , and 0.74 , respectively ) followed by group 3 ( 0.14 , 0.37 , and 0.12 , respectively ) .
RESULTS	The OHI-S , PI , and GI scores increased in group 1 ( 0.66 , 0.37 , and 0.34 , respectively ) and group 2 ( 0.25 , 0.19 , and 0.14 , respectively ) .
RESULTS	Mean decayed , missing filled surfaces score between the groups was not statistically significant at baseline and postintervention .
CONCLUSIONS	The dramatic reductions in the OHI-S , PI , and GI scores in the group supplied with oral hygiene aids call for supplying low cost fluoridated toothpastes along with toothbrushes through the school systems in rural areas .

###24553103
BACKGROUND	Although most mirror therapy studies have shown improved motor performance in stroke patients , the optimal mirror training protocol still remains unclear .
OBJECTIVE	To study the relative contribution of a mirror in training a reaching task and of unilateral and bimanual training with a mirror .
METHODS	A total of 93 stroke patients at least 6 months poststroke were instructed to perform a reaching task as fast and as fluently as possible .
METHODS	They performed 70 practice trials after being randomly allocated to 1 of 5 experimental groups : training with ( 1 ) the paretic arm with direct view ( Paretic-No Mirror ) , ( 2 ) the nonparetic arm with direct view ( Nonparetic-No Mirror ) , ( 3 ) the nonparetic arm with mirror reflection ( Nonparetic Mirror ) , ( 4 ) both sides and with a nontransparent screen preventing visual control of paretic side ( Bilateral-Screen ) , and ( 5 ) both sides with mirror reflection of the nonparetic arm ( Bilateral-Mirror ) .
METHODS	As baseline and follow-up , patients performed 6 trials using only their paretic side .
METHODS	Primary outcome measure was the movement time .
RESULTS	We found the largest intervention effect in the Paretic-No Mirror condition .
RESULTS	However , the Nonparetic-Mirror condition was not significantly different from the Paretic-No Mirror condition , while the Unaffected-No Mirror condition had significantly less improvement than the Paretic-No Mirror condition .
RESULTS	In addition , movement time improved significantly less in the bimanual conditions and there was no difference between both bimanual conditions or between both mirror conditions .
CONCLUSIONS	The present study confirms that using a mirror reflection can facilitate motor learning .
CONCLUSIONS	In this task , bimanual movement using mirror training was less effective than unilateral training .

###24548581
OBJECTIVE	To examine the relationships between parental patterns regarding child feeding and child body mass index ( BMI ) percentile in Latino parent-preschooler dyads participating in a clinical trial .
METHODS	This secondary analysis examined data collected during a randomized clinical trial of a culturally tailored healthy lifestyle intervention focused on childhood obesity prevention , Salud Con La Familia .
METHODS	We analyzed 77 Latino parent-child dyads who completed baseline and 3-month follow-up data collection , assessing associations between preschool child BMI percentile and parental response to the Child Feeding Questionnaire ( CFQ ) over time .
RESULTS	Higher child BMI was related to higher parental CFQ concern scores ( r = 0.41 , p < .001 ) .
RESULTS	A general inverse association between child BMI percentile and parental responsibility was also observed ( r = -0.23 , p = .040 ) .
RESULTS	Over the 3-month period , no statistically significant associations between changes in the CFQ subscale scores and changes in child BMI percentile were identified .
CONCLUSIONS	Child BMI percentile consistent with overweight/obese is associated with parental concern about child weight and child BMI percentile consistent with normal weight is associated with perceived responsibility for feeding .
CONCLUSIONS	Emphasizing parental responsibility to help children to develop healthy eating habits could be an important aspect of interventions aimed at both preventing and reducing pediatric obesity for Latino preschoolers .

###25378647
OBJECTIVE	A randomized , crossover , double-blinded placebo-controlled and non-blinded active drug-controlled , comparative clinical trial was conducted to evaluate the efficacy and safety of sublingual fentanyl tablet .
METHODS	Subjects were patients treated with strong opioids at fixed intervals for chronic cancer pain and with oral morphine as rescue medication for breakthrough pain .
METHODS	Sublingual fentanyl was administered at doses that were 1/25th ( high dose ) and 1/50th ( low dose ) of the dose of rescue morphine and was compared with placebo and oral morphine .
METHODS	The primary endpoint was pain intensity difference at 30 min after administration .
METHODS	( Clinical Trials Government ; NCT00684632 ) .
RESULTS	Fifty-one patients were enrolled in the investigation .
RESULTS	Their mean pain intensity in visual analog scale before rescue medication prior to the investigation was 60.96 ( 16.44 , standard deviation ) mm .
RESULTS	Compared with placebo , the low and high doses of sublingual fentanyl showed significant analgesic effects ( least squares mean difference , 4.54 and 8.49 mm ; P = 0.014 , P < 0.001 , respectively ) .
RESULTS	Adverse reactions were observed in 17.6 % , the most common being constipation , nausea and somnolence .
RESULTS	The incidence of adverse reactions during the high-dose administration period was higher than that during the low-dose and active control drug administration periods .
CONCLUSIONS	Patients treated with strong opioid analgesics at fixed intervals for chronic cancer pain and with oral morphine at doses up to 20 mg as rescue medication were investigated .
CONCLUSIONS	The doses of sublingual fentanyl to treat breakthrough pain were determined from rescue morphine doses by use of conversion ratios .
CONCLUSIONS	In these patients , administration of sublingual fentanyl at doses determined by a conversion ratio of 1/50 was effective and safe .
CONCLUSIONS	Further studies are needed to validate the use of this conversion method .

###24958736
BACKGROUND	NSABP C-06 demonstrated the non-inferiority of oral adjuvant uracil and tegafur plus leucovorin ( UFT/LV ) to weekly fluorouracil and folinate ( 5-FU/LV ) with respect to disease-free survival ( DFS ) for stage II/III colon cancer .
BACKGROUND	This is the first report of JCOG0205 , which compared UFT/LV to standard 5-FU/levofolinate ( l-LV ) for stage III colorectal cancer patients who have undergone Japanese D2/D3 lymph node dissection .
METHODS	Patients were randomised to three courses of 5-FU/l-LV ( 5-FU 500 mg/m ( 2 ) , l-LV 250 mg/m ( 2 ) on days 1 , 8 , 15 , 22 , 29 , 36 every 8 weeks ) or five courses of UFT/LV ( UFT 300 mg m ( -2 ) day ( -1 ) , LV 75 mg/day on days 1-28 every 5 weeks ) .
METHODS	The primary end-point was DFS .
METHODS	The sample size was 1100 determined with one-sided alpha of 0.05 , power of 0.78 and non-inferiority margin of hazard ratio of 1.27 .
METHODS	This trial is registered with UMIN-CTR ( C000000193 ) .
RESULTS	Between February 2003 and November 2006 , 1,101 patients ( 1092 eligible patients ) were randomised to 5-FU/l-LV ( n = 550 ) or UFT/LV ( n = 551 ) .
RESULTS	Median age : 61 years , colon/rectum : 67 % / 33 % , number of positive nodes 3 / > 3 : 73 % / 27 % , stage IIIa/IIIb : 75 % / 25 % .
RESULTS	The hazard ratio of DFS was 1.02 ( 91.3 % confidence interval , 0.84-1 .23 ) , demonstrating the non-inferiority of UFT/LV ( P = 0.0236 ) .
RESULTS	Five-year overall survival ( 87.5 % ) was higher than that in NSABP C-06 ( 69.6 % ) .
RESULTS	Grade 3/4 toxicities were 8.4 % neutropenia in 5-FU/l-LV and 8.7 % alanine aminotransferase elevation in UFT/LV , respectively .
RESULTS	The incidences of diarrhoea ( 9.6 % versus 8.5 % ) and anorexia ( 4.0 % versus 3.7 % ) were similar between the two arms .
RESULTS	No treatment-related deaths were reported .
CONCLUSIONS	Adjuvant UFT/LV is non-inferior to standard 5-FU/l-LV with respect to DFS .
CONCLUSIONS	UFT/LV should be an oral treatment option for patients with stage III colon cancer who have undergone Japanese D2/D3 lymph node dissection .

###25345354
BACKGROUND	As no human data exist , we aimed to determine the relation between ambient temperature and volume of perihematomal ` cerebral ' edema in acute spontaneous intracerebral haemorrhage ( ICH ) among Chinese participants of the pilot phase , Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial ( INTERACT1 ) .
METHODS	INTERACT1 was a multicenter , open , blind outcome assessed , randomized controlled trial of intensive ( systolic target < 140mmHg ) vs. guideline-recommended ( systolic target < 180mmHg ) blood pressure ( BP ) lowering in 404 patients with acute ICH .
METHODS	Data on ambient temperature ( mean , minimum , maximum , and range ) on the day of each participant 's ICH obtained from China Meteorological Data Sharing Service System were linked to other data including edema volumes .
METHODS	Multivariable regression analyses were performed to evaluate association between ambient temperature and edema volumes .
METHODS	A generalized linear regression model with a generalized estimating equations approach ( GEE ) was used to assess any association of ambient temperature and change in edema volume over 72h .
RESULTS	A total of 250 of all 384 Chinese participants had complete data that showed positive associations between ambient temperature ( mean and minimum temperatures ) and edema volumes at each time point over 72h after hospital admission ( all P < 005 ) .
RESULTS	All temperature parameters except diurnal temperature range were positively associated with edema volume after adjustment for confounding variables ( all P < 002 ) .
CONCLUSIONS	An apparent positive association exists between ambient temperature and perihematomal edema volume in acute spontaneous ICH .

###24571205
OBJECTIVE	To gain further evidence on the efficacy , safety and tolerability of tadalafil 5mg once-daily in Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia .
METHODS	Japanese and Korean men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia were randomized to once-daily tadalafil 5mg ( n = 306 ) or placebo ( n = 304 ) for 12 weeks .
RESULTS	A significantly greater improvement ( P < 0.001 ) in total International Prostate Symptom Score for the change from baseline ( week 0 ) to study end-point ( week 12 ) was observed for tadalafil ( -6.0 ) versus placebo ( -4.5 ) .
RESULTS	Significantly greater improvements ( P < 0.01 ) in total International Prostate Symptom Score for the change from baseline to weeks 4 and 8 were observed for tadalafil versus placebo .
RESULTS	Significantly greater improvements ( P < 0.05 ) in International Prostate Symptom Score voiding and storage subscores , and International Prostate Symptom Score Quality of Life Index were observed for the change from baseline to end-point for tadalafil versus placebo .
RESULTS	Significantly greater improvements ( P < 0.001 ) in urinary symptoms were observed for tadalafil versus placebo for both Patient and Clinician Global Impressions of Improvement .
RESULTS	No new safety concerns were identified .
CONCLUSIONS	These findings confirm the efficacy and safety profile of tadalafil 5mg once-daily in Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia .

###24644106
OBJECTIVE	This was a flexible-dosed study to evaluate the efficacy and safety of duloxetine 30-120mg once daily in the treatment of generalized anxiety disorder ( GAD ) in older adult patients .
METHODS	Patients with GAD , who were at least 65years of age , were randomly assigned to double-blind treatment with either duloxetine ( N = 151 ) or placebo ( N = 140 ) .
METHODS	The primary efficacy measure was the Hamilton Anxiety Rating Scale ( HAM-A ) total score , and the primary endpoint was at week 10 .
METHODS	Global functioning was assessed by the Sheehan Disability Scale ( SDS ) .
METHODS	Safety and tolerability was assessed by the occurrence of treatment-emergent adverse events , serious adverse events , laboratory analyses , and vital signs .
METHODS	Analyses were conducted on an intent-to-treat basis .
RESULTS	The overall baseline mean HAM-A total score was 24 , and SDS global score was 14 .
RESULTS	Completion rates were 75 % for placebo and 76 % for duloxetine .
RESULTS	At week 10 , duloxetine was superior to placebo on mean changes from baseline in HAM-A total scores ( -15.9 vs. -11.7 , p < 0.001 ) and in SDS global scores ( -8.6 vs. -5.4 , p < 0.001 ) .
RESULTS	Treatment-emergent adverse events occurred in 5 % of duloxetine-treated patients and twice the rate than with placebo including constipation ( 9 % vs. 4 % , p = 0.06 ) , dry mouth ( 7 % vs. 1 % , p = 0.02 ) , and somnolence ( 6 % vs. 2 % , p = 0.14 ) .
CONCLUSIONS	Duloxetine treatment was efficacious in the improvement of anxiety and functioning in older adult patients with GAD , and the safety profile was consistent with previous GAD studies .

###25128022
BACKGROUND	Because of ongoing controversy , renal and vital outcomes are compared between systemically administered unfractionated heparin and regional anticoagulation with citrate-buffered replacement solution in predilution mode , during continuous venovenous hemofiltration ( CVVH ) in critically ill patients with acute kidney injury ( AKI ) .
METHODS	In this multi-center randomized controlled trial , patients admitted to the intensive care unit requiring CVVH and meeting inclusion criteria , were randomly assigned to citrate or heparin .
METHODS	Primary endpoints were mortality and renal outcome in intention-to-treat analysis .
METHODS	Secondary endpoints were safety and efficacy .
METHODS	Safety was defined as absence of any adverse event necessitating discontinuation of the assigned anticoagulant .
METHODS	For efficacy , among other parameters , survival times of the first hemofilter were studied .
RESULTS	Of the 139 patients enrolled , 66 were randomized to citrate and 73 to heparin .
RESULTS	Mortality rates at 28 and 90 days did not differ between groups : 22/66 ( 33 % ) of citrate-treated patients died versus 25/72 ( 35 % ) of heparin-treated patients at 28 days , and 27/65 ( 42 % ) of citrate-treated patients died versus 29/69 ( 42 % ) of heparin-treated patients at 90 days ( P = 1.00 for both ) .
RESULTS	Renal outcome , i.e. independency of renal replacement therapy 28 days after initiation of CVVH in surviving patients , did not differ between groups : 29/43 ( 67 % ) in the citrate-treated patients versus 33/47 ( 70 % ) in heparin-treated patients ( P = 0.82 ) .
RESULTS	Heparin was discontinued in 24/73 ( 33 % ) of patients whereas citrate was discontinued in 5/66 ( 8 % ) of patients ( P < 0.001 ) .
RESULTS	Filter survival times were superior for citrate ( median 46 versus 32 hours , P = 0.02 ) , as were the number of filters used ( P = 0.002 ) and the off time within 72 hours ( P = 0.002 ) .
RESULTS	The costs during the first 72 hours of prescribed CVVH were lower in citrate-based CVVH .
CONCLUSIONS	Renal outcome and patient mortality were similar for citrate and heparin anticoagulation during CVVH in the critically ill patient with AKI .
CONCLUSIONS	However , citrate was superior in terms of safety , efficacy and costs .
BACKGROUND	Clinicaltrials.gov NCT00209378 .
BACKGROUND	Registered 13th September 2005 .

###24489648
OBJECTIVE	The aim of the present study was to evaluate the effectiveness of a worksite mindfulness-related multi-component health promotion intervention on work engagement , mental health , need for recovery and mindfulness .
METHODS	In a randomized controlled trial design , 257 workers of two research institutes participated .
METHODS	The intervention group ( n = 129 ) received a targeted mindfulness-related training , followed by e-coaching .
METHODS	The total duration of the intervention was 6 months .
METHODS	Data on work engagement , mental health , need for recovery and mindfulness were collected using questionnaires at baseline and after 6 and 12 months follow-up .
METHODS	Effects were analyzed using linear mixed effect models .
RESULTS	There were no significant differences in work engagement , mental health , need for recovery and mindfulness between the intervention and control group after either 6 - or 12-months follow-up .
RESULTS	Additional analyses in mindfulness-related training compliance subgroups ( high and low compliance versus the control group as a reference ) and subgroups based on baseline work engagement scores showed no significant differences either .
CONCLUSIONS	This study did not show an effect of this worksite mindfulness-related multi-component health promotion intervention on work engagement , mental health , need for recovery and mindfulness after 6 and 12 months .
BACKGROUND	Netherlands Trial Register NTR2199 .

###25450131
OBJECTIVE	To compare maximal evoked torque , discomfort , and fatigue-related outcomes between multipath neuromuscular electrical stimulation ( NMES ) and conventional NMES of the quadriceps muscle in patients with total knee arthroplasty ( TKA ) .
METHODS	Randomized , single-blind , crossover study with 2 experimental sessions ( multipath NMES , conventional NMES ) .
METHODS	Research laboratory .
METHODS	Patients ( N = 20 ; mean age , 68y ) 6 to 12 months after TKA surgery .
METHODS	None .
METHODS	We quantified NMES-evoked knee extension torque at the maximally tolerated current intensity , self-reported discomfort , and fatigue induced by NMES intermittent contractions in both conditions .
RESULTS	Compared with conventional NMES , multipath NMES resulted in higher evoked torque ( 33 % , P < .001 ) , lower discomfort scores ( -39 % , P < .001 ) , and less quadriceps muscle fatigue ( P = .034 ) .
CONCLUSIONS	The use of multiple current pathways distributed to large electrodes allowed multipath NMES to generate stronger contractions and reduce discomfort and fatigue compared with conventional NMES .
CONCLUSIONS	Therefore , multipath NMES has the potential to be more effective than conventional NMES .

###24980063
OBJECTIVE	The aim was to evaluate the impact of the ` Healthy Dads , Healthy Kids ' programme on fathers ' and mothers ' activity - and diet-related parenting practices .
METHODS	Overweight/obese fathers ( n = 87 ) and their primary school-aged children ( 56 % boys ) were randomized to either ( i ) 7-week programme ( n = 45 ) or ( ii ) control group ( n = 42 ) .
METHODS	The programme involved four sessions for fathers only and three for fathers/children .
METHODS	Mothers were not directly involved .
METHODS	Parenting practices of both fathers and mothers were measured using the parenting strategies for eating and activity scale at baseline and 14-week follow-up .
RESULTS	Intention-to-treat analysis using linear mixed models revealed significant group-by-time effects for fathers ' limit setting ( P = 0.048 , d = 0.36 ) and reinforcement for multiple lifestyle behaviours ( P = 0.001 , d = 0.79 ) .
RESULTS	No significant intervention effects were found for fathers ' control , monitoring , discipline or mothers ' parenting practices ( P > 0.05 ) .
CONCLUSIONS	The Healthy Dads , Healthy Kids programme had a positive impact on some parenting practices for fathers but not mothers .

###24435105
BACKGROUND	The Pilates method has been widely used to treat patients with chronic low back pain .
BACKGROUND	Pilates exercises can be performed in 2 ways : by using specific equipment or without it ( also known as mat Pilates ) .
BACKGROUND	There are no studies , however , that have compared the effectiveness of mat Pilates with that of equipment-based Pilates .
OBJECTIVE	The aim of this study was to compare the effectiveness of mat Pilates and equipment-based Pilates in patients with chronic nonspecific low back pain .
METHODS	A 2-arm randomized controlled trial with a blinded assessor was conducted .
METHODS	The study was conducted at a private physical therapy clinic in Brazil .
METHODS	Eighty-six patients with chronic nonspecific low back pain participated .
METHODS	The patients were randomly allocated to 1 of 2 groups : a mat Pilates group ( n = 43 ) and an equipment-based Pilates group ( n = 43 ) .
METHODS	The participants in both groups attended 12 Pilates sessions over a period of 6 weeks .
METHODS	The primary outcomes were pain intensity and disability .
METHODS	The secondary outcomes were global perceived effect , patient 's specific disability , and kinesiophobia .
METHODS	A blinded assessor evaluated the outcomes at baseline and 6 weeks and 6 months after randomization .
RESULTS	After 6 months , there was a statistically significant difference for disability ( mean difference = 3.0 points , 95 % confidence interval [ CI ] = 0.6 to 5.4 ) , specific disability ( mean difference = -1.1 points , 95 % CI = -2.0 to -0.1 ) , and kinesiophobia ( mean difference = 4.9 points , 95 % CI = 1.6 to 8.2 ) in favor of equipment-based Pilates .
RESULTS	No differences were found for the remaining outcomes .
CONCLUSIONS	Equipment-based Pilates was superior to mat Pilates in the 6-month follow-up for the outcomes of disability and kinesiophobia .
CONCLUSIONS	These benefits were not observed for pain intensity and global perceived effect in patients with chronic nonspecific low back pain .

###24518166
OBJECTIVE	To assess the effect of a weight-loss program on improving iron status in overweight and obese school-aged children .
METHODS	The data were analyzed in overweight and obese children ( 7-11 years of age ; 114 girls and 212boys ) with body mass index-for-age z-scores ( BAZ ) > 1 from a weight-loss program .
METHODS	Schools were randomly divided into 2 groups : intervention and control .
METHODS	Children in the intervention group underwent a 1-year , nutrition-based comprehensive intervention weight-loss program .
METHODS	Anthropometric , dietary intake , and physical activity data were collected at baseline and follow-up ( 1 year ) .
METHODS	Iron status and inflammatory markers were assessed within a month .
RESULTS	In the intervention group , BAZ decreased more than that in the control group ( -0.4 0.7 vs -0.1 0.6 , P < .0001 ) ; and iron profiles and inflammation status were improved at follow-up .
RESULTS	In multivariable linear regression models , a greater decrease of BAZ and inflammation factors predicted a better improvement of iron status .
RESULTS	After adjustment of BAZ , C-reactive protein was significantly associated with serum ferritin ( : 1.89 ; 95 % CI , 0.70-3 .09 ; P = .002 ) and soluble transferrin receptor ( : 0.88 ; 95 % CI , 0.16-0 .59 ; P = .017 ) ; interleukin-6 was significantly associated with serum ferritin ( : 1.22 ; 95 % CI , 0.64-1 .79 ; P < .0001 ) .
CONCLUSIONS	Iron status and inflammation were improved by weight reduction .
CONCLUSIONS	The improvement in inflammatory markers during weight reduction was independently associated with improvements of iron status .

###24437213
OBJECTIVE	To evaluate the efficiency and safety of two treatment regimens using ramipril or losartan in combination with hydrochlorothiazide ( HCT ) and amlodipine in grade 1-2 arterial hypertension ( AH ) .
METHODS	The prospective , international , multicenter , randomized , open-label , controlled trial with parallel groups included 347 AH patients in Russia ( n = 166 ) , Croatia , and Ukraine .
METHODS	The follow-up was 12 weeks in patients not receiving antihypertensive therapy ( AHT ) and 13 weeks in those who had previously received AHT with regard to a washout period .
METHODS	The basis for two treatment regimens was ramipril or losartan .
METHODS	If no target blood pressure ( BP ) was achieved , amlodipine or HCT was added at week 4 and a third antihypertensive drug ( AHD ) was used 8 weeks later .
RESULTS	At the inclusion , clinical BP was 157.64 / 95.5 mm Hg in 332 ( 61 % ) AH patients aged 55.9 + / - 11 years .
RESULTS	At week 4 of monotherapy with ramipil 5 mg or losartan 50 mg , BP was reduced to 141.9 / 87.4 mm Hg .
RESULTS	Addition of a second AHD further lowered BP to 131.8 / 81.9 mm Hg ( to 127.6 / 79.7 at 12 weeks of treatment ; p < 0.001 ) .
RESULTS	After 4 weeks of treatment with ramipril 5 mg or losartan 50 mg , 35 % of the patients achieved target BP .
RESULTS	At weeks 8 and 12 , double or triple AHT increased the number of patients achieving the target level up to 75 and 94 % , respectively .
RESULTS	When losartan was used as monotherapy , about one third of the patients achieved target BP ; 20 and 22 % of the patients required the addition of a second AHD ( HCT and amlodipine , respectively ) .
RESULTS	Only 10 % of the patients needed to take a combination of three AHDs .
RESULTS	Nearly one third of the patients achieved target BP during monotherapy with losartan or ramipril .
RESULTS	Double AHT involving ramipril or losartan in combination with the diuretic or amlodipine was used in 18 and 20 % and in 22 and 24 % of the patients , respectively .
RESULTS	28 and 19 % of the patients received triple therapy including ramipril or losartan , amlodipine , and HCT .
RESULTS	The most common adverse reactions were dizziness ( 2.4 % ) , fatigue ( 1.8 % ) , and coughing ( 1.2 % ) .
CONCLUSIONS	In the patients with grades 1-2 AH , the treatment regimens using basic therapy with ramipril or losartan proved to be highly effective and allowed target BP to be achieved in 94 % of cases .
CONCLUSIONS	Both treatment regimens were comparable in view of safety ; slight side effects occurred rarely ( in less than 2.5 % of the patients ) and required that the treatment should not be discontinued .

###25194077
OBJECTIVE	To evaluate the efficacy of diode laser ablation of prostate for treating lower urinary tract symptoms ( LUTS ) in patients with locally advanced prostate cancer and comparing results with palliative transurethral resection of prostate ( pTURP ) .
METHODS	Thirty-six known cases of locally advanced prostate cancer with a maximum urinary flow rate ( Qmax ) of 12 mL per second or less and an International Prostate Symptom Score ( IPSS ) of 20 or more were included in this study .
METHODS	Patients were randomized into two groups .
METHODS	The first group underwent pTURP and for the second group diode laser ablation of prostate was done .
METHODS	In 6 months post-operative follow up , patients were evaluated for IPSS , post void residual ( PVR ) urine volume , Qmax and possible complications such as urethral stricture or urinary incontinence .
RESULTS	Postoperatively , mean IPSS was 11.1 4.1 in TURP group and 11.7 3.6 in laser group ( P = .64 ) .
RESULTS	Mean PVR was 18.4 3.5 mL in TURP group and 17.7 6.3 mL in laser group ( P = .68 ) .
RESULTS	Mean Qmax in TURP and laser groups were measured 20.1 4.5 mL/s and 19.4 2.6 mL/s , respectively ( P = .57 ) .
RESULTS	While there was a significant improvement in IPSS and Qmax and PVR in both groups , statistical analysis did not show any significant difference postoperatively between pTURP and laser groups .
CONCLUSIONS	Diode laser ablation of prostate and pTURP , both improved significantly IPSS , PVR and Qmax .
CONCLUSIONS	But hospital stay and post-operative catheterization time was less in laser group .

###24263044
OBJECTIVE	Postoperative nausea and vomiting ( PONV ) occur frequently after laparoscopic bariatric surgery .
OBJECTIVE	The combination of haloperidol , dexamethasone , and ondansetron may reduce these undesirable events .
OBJECTIVE	The aim of this study was to evaluate the intensity of nausea and pain , the number of vomiting episodes , and morphine consumption in postoperative ( PO ) obese patients undergoing laparoscopic sleeve gastrectomy ( LSG ) .
METHODS	A clinical , randomized , controlled , double-blind study conducted with 90 patients with body mass index 35 kg.cm-2 .
METHODS	Patients were divided into three groups of 30 individuals to receive ondansetron 8 mg ( Group O ) ; ondansetron 8 mg and dexamethasone 8 mg ( Group OD ) ; and ondansetron 8 mg , dexamethasone 8 mg , and haloperidol 2 mg ( Group HDO ) .
METHODS	We evaluated the intensity of nausea and pain using the verbal numeric scale , cumulative number of vomiting episodes , and morphine consumption in the period of 0-2 , 2-12 , 12-24 , and 24-36 hours postoperatively .
RESULTS	Nausea intensity was lower in Group HDO compared to Group O ( p = 0.001 ) , pain intensity was lower in Group HDO compared to Group O ( p = 0.046 ) , and morphine consumption was lower in Group HDO compared to Group O ( p = 0.037 ) .
RESULTS	There was no difference between groups regarding the number of vomiting episodes ( p = 0.052 ) .
CONCLUSIONS	The combination of haloperidol , ondansetron , and dexamethasone reduced nausea and pain intensity and morphine consumption in postoperative obese patients undergoing LSG .

###25070393
OBJECTIVE	This study compared the biocompatibility and comfort of 4 lens care solutions currently marketed in France .
METHODS	This was a randomized , interventional , double-masked , single-center crossover study assessing balafilcon A silicone hydrogel contact lenses , bilaterally , straight from the blister pack solution ( control ) and pre-soaked in the following lens care solutions : Regard ( ) ( containing sodium chlorite ) , ReNu ( ) ( containing a PHMB [ polyhexamethylene biguanide ] derivative ) , CyClean and MeniCare Soft ( both containing PHMB ) .
METHODS	Subjects were randomized to the order of test solution use .
METHODS	For each of the 5 solutions tested , subjects attended a baseline/lens dispensing visit and an intervention visit 2h later .
METHODS	At both visits , evaluation included slit-lamp examination , corrected-distance visual acuity , corneal staining , and subject-assessed photophobia , ocular comfort , and ocular redness .
RESULTS	Thirty subjects were enrolled and 28 were evaluable .
RESULTS	Corneal staining severity was significantly worse than baseline after 2h of wearing lenses soaked in CyClean , MeniCare , or ReNu ( P0 .001 ) .
RESULTS	The MeniCare group alone demonstrated a significant improvement in ocular comfort after 2h of lens wear ( P = 0.02 ) .
RESULTS	No group demonstrated significant changes in ocular redness or photophobia .
RESULTS	Corrected-distance visual acuity was similar between baseline and intervention visits for each test solution .
RESULTS	No adverse events were reported during the study .
CONCLUSIONS	Silicone hydrogel contact lenses presoaked in lens solutions containing PHMB or a PHMB derivative produced an increase in corneal staining after 2h of lens wear .
CONCLUSIONS	The higher levels of corneal staining in the 2 solutions did not correlate with increased discomfort within this 2-h timeframe .

###24720928
OBJECTIVE	The purpose of this study was to examine the relationship between fatigue and clinical outcomes , using dyspnea as a comparator , in patients with left ventricular ejection fraction ( LVEF ) 35 % enrolled in the CORONA ( Controlled Rosuvastatin Multinational Trial in Heart Failure ) study .
BACKGROUND	Although fatigue is a common symptom in heart failure ( HF ) , little is known about its association with prognosis .
METHODS	At baseline in CORONA , fatigue `` during the past few days '' was measured using a 5-point exertion scale ( 0 = none , 1 = heavy exertion , 2 = moderate exertion , 3 = slight exertion , 4 = rest ) ; a 4-point scale was used for dyspnea ( 1 to 4 as for fatigue ) .
METHODS	Patients were grouped into 3 categories : a fatigue score 0 to 1 ( n = 535 ) , fatigue score 2 ( n = 1,632 ) , and fatigue score 3 to 4 ( n = 1,663 ) ; and a dyspnea score of 1 ( n = 292 ) , dyspnea score of 2 ( n = 1,695 ) , and dyspnea score of 3 to 4 ( n = 1,843 ) .
METHODS	The association between fatigue and dyspnea and the composite outcome of cardiovascular ( CV ) death or HF hospital stay and each component separately was examined using Kaplan-Meier analysis and Cox proportional-hazard models .
METHODS	We also examined all-cause mortality .
RESULTS	In univariate analyses , symptom severity was associated with a higher risk of CV death or HF hospital stay ( fatigue : group 3 , 49 % [ n = 810 ] , vs. group 1 , 30 % [ n = 160 ] ; dyspnea : group 3 , 50 % [ n = 918 ] , vs. group 1 , 28 % [ n = 82 ] ) and all-cause mortality ( fatigue : group 3 , 38 % [ n = 623 ] , vs. group 1 , 24 % [ n = 130 ] ; dyspnea : group 3 , 38 % [ n = 697 ] , vs. group 1 , 23 % [ n = 66 ] , log-rank p < 0.0001 for all ) .
RESULTS	After adjusting for other prognostic variables , including LVEF , New York Heart Association class , and N-terminal pro-B-type natriuretic peptide level , worse fatigue remained associated with higher risk of HF hospital stay but not mortality ( worse dyspnea remained associated with a higher risk of both ) .
RESULTS	An increase in fatigue ( or dyspnea ) between baseline and 6 months was also associated with worse outcomes .
CONCLUSIONS	In HF , greater fatigue is associated with worse clinical outcomes .
CONCLUSIONS	Closer attention should be paid to this symptom in clinical practice , with more done to standardize its measurement and understand its origins , with a view to improving treatment .

###24312450
BACKGROUND	We have recently described an increased lymphocytic infiltration rate in breast carcinoma tissue is a significant response predictor for anthracycline/taxane-based neoadjuvant chemotherapy ( NACT ) .
BACKGROUND	The aim of this study was to prospectively validate the tumor-associated lymphocyte infiltrate as predictive marker for response to anthracycline/taxane-based NACT .
METHODS	The immunological infiltrate was prospectively evaluated in a total of 313 core biopsies from HER2 negative patients of the multicenter PREDICT study , a substudy of the neoadjuvant GeparQuinto study .
METHODS	Intratumoral lymphocytes ( iTuLy ) , stromal lymphocytes ( strLy ) as well as lymphocyte-predominant breast cancer ( LPBC ) were evaluated by histopathological assessment .
METHODS	Pathological complete response ( pCR ) rates were analyzed and compared between the defined subgroups using the exact test of Fisher .
RESULTS	Patients with lymphocyte-predominant breast cancer ( LPBC ) had a significantly increased pCR rate of 36.6 % , compared to non-LPBC patients ( 14.3 % , p < 0.001 ) .
RESULTS	LPBC and stromal lymphocytes were significantly independent predictors for pCR in multivariate analysis ( LPBC : OR 2.7 , p = 0.003 , strLy : OR 1.2 , p = 0.01 ) .
RESULTS	The amount of intratumoral lymphocytes was significantly predictive for pCR in univariate ( OR 1.2 , p = 0.01 ) but not in multivariate logistic regression analysis ( OR 1.2 , p = 0.11 ) .
CONCLUSIONS	Confirming previous investigations of our group , we have prospectively validated in an independent cohort that an increased immunological infiltrate in breast tumor tissue is predictive for response to anthracycline/taxane-based NACT .
CONCLUSIONS	Patients with LPBC and increased stromal lymphocyte infiltration have significantly increased pCR rates .
CONCLUSIONS	The lymphocytic infiltrate is a promising additional parameter for histopathological evaluation of breast cancer core biopsies .

###24432671
OBJECTIVE	To formulate a comprehensive treatment program for rheumatoid arthritis arthralgia by clinical observing the efficacy of Xiaoyan Zhitong Paste ( XZP ) .
METHODS	Adopted was stratified , block randomized , double-blinded , placebo parallel controlled method .
METHODS	Subjects were assigned to the treatment group and the placebo group .
METHODS	Those in the treatment group were treated by external application of XZP , one to two pastes each time , covering the painful area , exchange once per 24 h , with one-day interval during a 7-day consecutive medication , two 7-days of treatment consisting of one therapeutic course .
METHODS	XZP placebos were applied for those in the placebo group in the same medication way .
METHODS	Joint pain and VAS were taken as main indices for observing the clinical efficacy of XZP .
RESULTS	The improvement of the analgesic effect and the Chinese medical syndrome efficacy of XZP were superior to that of the placebo .
CONCLUSIONS	XZP showed obvious effect in treating rheumatoid arthritis arthralgia with no obvious adverse reaction .

###25495109
OBJECTIVE	A patient-centered collaborative care program for depression and uncontrolled diabetes and/or coronary heart disease ( CHD ) demonstrated improved clinical outcomes relative to usual care .
OBJECTIVE	We report clinically stratified analyses of patient outcomes to inform the duration and targeting of care management services for complex patients with multimorbidity .
METHODS	A 12-month randomized controlled trial of a multimorbidity collaborative care program followed patients at 6 , 12 , 18 , and 24 months for diabetes ( glycated hemoglobin [ A1C ] ) , blood pressure ( systolic ; SBP ) , low-density lipoprotein ( LDL ) cholesterol , and depression ( Symptoms Check List-20 score ) .
METHODS	Depressed patients with less favorable medical control ( Patient Health Questionnaire-9 score > 10 , A1C > 8.0 % , SBP > 140 mm Hg , and LDL cholesterol > 120 mg/dL ) were compared with depressed patients with more favorable medical control to describe differential intervention benefits over time .
RESULTS	In contrast to patients with more favorable baseline control , patients with depression and unfavorable control of A1C , SBP , and LDL at baseline showed improved outcomes as early as the 6-month follow-up assessment .
RESULTS	Clinical benefits in the intervention group were largely sustained over the 24-month follow-up , except for some deterioration of glycemic control in intervention patients and trends toward improvement among controls over time .
RESULTS	Among patients with depression and more favorable medical control at baseline , there were minimal between-group differences in medical disease outcomes .
CONCLUSIONS	Clinical benefits of a multimorbidity collaborative care management program occurred early , and were only found among patients with poor control of baseline diabetes and CHD risk factors .
CONCLUSIONS	Targeting may maximize reach and improve affordability of complex care management .

###24634110
BACKGROUND	Recent data suggest that P-glycoprotein may be involved in cellular transport of lacosamide .
OBJECTIVE	To investigate potential drug-drug interactions ( DDIs ) between lacosamide and digoxin , this phase I , multiple-dose , randomised , double-blind , placebo-controlled , crossover trial assessed the pharmacokinetics , pharmacodynamics , safety and tolerability of digoxin administered in combination with lacosamide or placebo .
METHODS	Twenty healthy White male volunteers were randomised .
METHODS	After receiving digoxin 0.25 mg three times daily on day 1 ( loading dose ) , participants received digoxin 0.25 mg once daily on days 2-22 .
METHODS	Participants received either lacosamide ( 200 mg twice daily ) or placebo on days 8-11 and vice versa on days 18-21 , after a 6-day washout .
METHODS	The steady-state area under concentration-time curve over the dosing interval ( AUC ( 24 , ss ) ) and maximum steady-state plasma concentration ( C ( max , ss ) ) of digoxin were measured ; ratios of these parameters for co-administration of digoxin + lacosamide versus digoxin alone were used to evaluate potential DDIs .
METHODS	Interaction was excluded if the 90 % confidence interval ( CI ) for the geometric mean ratio of AUC24 , ss and C max , ss fell within the acceptance range for bioequivalence ( 0.8-1 .25 ) .
RESULTS	The point estimates ( 90 % CI ) of the geometric mean ratios for co-administration of digoxin with lacosamide versus digoxin alone for AUC ( 24 , ss ) [ 1.024 ( 0.979-1 .071 ) ] and C ( max , ss ) [ 1.049 ( 0.959-1 .147 ) ] were within the acceptance range for bioequivalence .
RESULTS	Digoxin and lacosamide co-administration was generally well-tolerated .
RESULTS	A small numerical increase in the mean PR interval following co-administered digoxin + lacosamide was observed versus digoxin alone and versus pre-treatment baseline values ( 178.5 vs. 170.4 or 166.8 ms , respectively ) .
RESULTS	The RR interval increased in parallel .
RESULTS	The change was not considered clinically relevant .
CONCLUSIONS	Co-administration of steady-state digoxin ( 0.25 mg/day ) with multiple-dose lacosamide ( 400 mg/day ) versus digoxin alone revealed no differences in digoxin disposition .

###24382677
OBJECTIVE	Providing care for terminally ill family members places an enormous burden on informal caregivers .
OBJECTIVE	Meaning in life ( MiL ) may be a protective factor , but is jeopardised in caregiving and bereavement .
OBJECTIVE	This study evaluates the following questions : To what extent do bereaved informal caregivers of palliative care ( PC ) patients experience meaning in their lives ?
OBJECTIVE	What differences emerge in carers compared to the general German population ?
OBJECTIVE	How does MiL relate to well-being in former caregivers ?
METHODS	Eighty-four bereaved PC caregivers completed the Schedule for Meaning in Life Evaluation , the Brief Symptom Inventory , the WHOQOL-BREF , a single-item numerical rating scale of quality of life , and the Satisfaction with Life Scale .
METHODS	The experience of MiL of bereaved caregivers was compared to a representative population sample ( n = 977 ) .
RESULTS	The overall MiL fulfillment of bereaved caregivers ( 69 % female , age 55.5 12.9 years ) was significantly lower than in the general population ( 68.5 19.2 vs. 83.3 14 , p < .001 ) , as was the overall importance ascribed to their meaning framework ( 76.6 13.6 vs. 85.6 12.3 , p < .001 ) .
RESULTS	PC caregivers are far more likely to list friends , leisure , nature/animals , and altruism .
RESULTS	Higher MiL was correlated with better life satisfaction and quality of life .
CONCLUSIONS	Coping with the loss of a loved one is associated with changes in MiL framework and considerably impairs a carer 's experience of MiL fulfillment .
CONCLUSIONS	Individual MiL is associated with well-being in PC caregivers during early bereavement .
CONCLUSIONS	Specific interventions for carers targeted at meaning reconstruction during palliative care and bereavement are needed to help individuals regain a sense of meaning and purpose .

###24997819
OBJECTIVE	To compare periodontal ligament anesthesia using a computer-controlled local anesthetic delivery system ( C-CLADS ) and submucosal infiltration anesthesia using a manually operated syringe in terms of the injection pain , anesthetic effect , anesthetic dose , and complications in healthy volunteers .
METHODS	Fifty healthy volunteers , aged 18 to 56 years , were recruited from September 2012 to May 2013 in the Department of Stomatology of Peking Union Medical College Hospital .
METHODS	A randomized self-controlled trial was conducted by applying a periodontal ligament anesthesia on one side and conventional manual submucosal infiltration anesthesia to the other ( control ) side .
METHODS	The differences in the onset time of anesthesia , drug dosage , anesthetic effect , and the degree of injection pain were compared .
METHODS	The complications associated with the two anesthesia methods were also recorded .
RESULTS	When using C-CLADS to perform a periodontal ligament anesthesia , the drug dosage and the severity of injection pain were significantly less than those of conventional manual infiltration anesthesia [ drug dosage : ( 0.340.09 ) ml vs. ( 0.550.13 ) ml , P < 0.01 ; VRS : 0.420.73 vs. 1.380.92 , P < 0.01 ; VAS : 1.341.21 vs. 3.101.70 , P < 0.01 ] .
RESULTS	The anesthesia success rate was approximately 90.0 % , showing no significant difference relative to conventional submucosal infiltration anesthesia .
RESULTS	Approximately 24 % of the volunteers experienced postoperative pain after periodontal ligament anesthesia .
CONCLUSIONS	Compared with conventional submucosal infiltration anesthesia using manual syringes , periodontal ligament anesthesia performed using C-CLADS can reduce the injection pain and drug dosage while achieving a satisfactory anesthetic effect ; however , a considerable proportion of cases may experience postoperative pain .

###24332516
BACKGROUND	Basal-cell carcinoma is the most common form of skin cancer and its incidence is increasing worldwide .
BACKGROUND	We aimed to assess the effectiveness of imiquimod cream versus surgical excision in patients with low-risk basal-cell carcinoma .
METHODS	We did a multicentre , parallel-group , pragmatic , non-inferiority , randomised controlled trial at 12 centres in the UK , in which patients were recruited between June 19 , 2003 , and Feb 22 , 2007 , with 3 year follow-up from June 26 , 2006 , to May 26 , 2010 .
METHODS	Participants of any age were eligible if they had histologically confirmed primary nodular or superficial basal-cell carcinoma at low-risk sites .
METHODS	We excluded patients with morphoeic or recurrent basal-cell carcinoma and those with Gorlin syndrome .
METHODS	Participants were randomly assigned ( 1:1 ) via computer-generated blocked randomisation , stratified by centre and tumour type , to receive either imiquimod 5 % cream once daily for 6 weeks ( superficial ) or 12 weeks ( nodular ) , or surgical excision with a 4 mm margin .
METHODS	The randomisation sequence was concealed from study investigators .
METHODS	Because of the nature of the interventions , masking of participants was not possible and masking of outcome assessors was only partly possible .
METHODS	The trial statistician was masked to allocation until all analyses had been done .
METHODS	The primary outcome was the proportion of participants with clinical success , defined as absence of initial treatment failure or signs of recurrence at 3 years from start of treatment .
METHODS	We used a prespecified non-inferiority margin of a relative risk ( RR ) of 0.87 .
METHODS	Analysis was by a modified intention-to-treat population and per protocol .
METHODS	This study is registered as an International Standard Randomised Controlled Trial ( ISRCTN48755084 ) , and with ClinicalTrials.gov , number NCT00066872 .
RESULTS	501 participants were randomly assigned to the imiquimod group ( n = 254 ) or the surgical excision group ( n = 247 ) .
RESULTS	At year 3 , 401 ( 80 % ) patients were included in the modified intention-to-treat group .
RESULTS	At 3 years , 178 ( 84 % ) of 213 participants in the imiquimod group were treated successfully compared with 185 ( 98 % ) of 188 participants in the surgery group ( RR 0.84 , 98 % CI 0.78-0 .91 ; p < 0.0001 ) .
RESULTS	No clear difference was noted between groups in patient-assessed cosmetic outcomes .
RESULTS	The most common adverse events were itching ( 211 patients in the imiquimod group vs 129 in the surgery group ) and weeping ( 160 vs 81 ) .
RESULTS	We recorded serious adverse events in 99 ( 40 % ) of 249 participants in the imiquimod group and 97 ( 42 % ) of 229 in the surgery group had serious adverse events , but none were regarded as related to treatment .
RESULTS	12 ( 5 % ) participants in the imiquimod group withdrew because of adverse events compared with four ( 2 % ) in the surgery group .
CONCLUSIONS	Imiquimod was inferior to surgery according to our predefined non-inferiority criterion .
CONCLUSIONS	Although excisional surgery remains the best treatment for low-risk basal-cell carcinoma , imiquimod cream might still be a useful treatment option for small low-risk superficial or nodular basal-cell carcinoma dependent on factors such as patient preference , size and site of the lesion , and whether the patient has more than one lesion .
BACKGROUND	Cancer Research UK .

###24464551
BACKGROUND	Sofosbuvir ( GS-7977 ) and GS-0938 are nucleotide analogue HCV polymerase inhibitors , with sofosbuvir being a pyrimidine and GS-0938 being a purine .
BACKGROUND	Mathematical modelling has provided important insights for characterizing HCV RNA decline and for estimating the in vivo effectiveness of single direct-acting antiviral agents ( DAAs ) ; however it has not been used to characterize viral kinetics with combination DAA therapy .
METHODS	We evaluated the antiviral activity of sofosbuvir and GS-0938 given alone and in combination for 14 days in 32 HCV genotype 1 treatment-naive patients ( P2938-0212 ; NUCLEAR study ) .
RESULTS	Viral load declined rapidly in a biphasic manner in all subjects and could be well fitted by assuming that both drugs had a similar and additive level of effectiveness in reducing viral production equal to 99.96 % , on average .
RESULTS	The model predicted that this level of effectiveness was not reached until 0.6 and 2 days for GS-0938 and sofosbuvir , respectively , and likely represents the time needed to accumulate intracellular triphosphates .
RESULTS	Subsequently , both drugs led to a rapid second phase of viral decline with a mean rate of 0.35 d ( -1 ) .
RESULTS	No effect of IL28B-polymorphism was found on viral kinetic parameters .
CONCLUSIONS	Both sofosbuvir and GS-0938 are highly effective at blocking viral production from HCV-infected cells .
CONCLUSIONS	Both drugs led to a rapid and consistent second phase viral decline and exhibited no breakthroughs or other signs of resistance .
CONCLUSIONS	From a kinetics perspective , because both drugs were of the same class there was little benefit in combining them , suggesting that future DAA combinations should consider utilizing drugs with different modes of action .

###25004265
OBJECTIVE	To evaluate the effects of early norepinephrine ( NE ) infusion in children submitted to mechanical ventilation ( MV ) requiring continuous sedative and analgesic infusion .
METHODS	Double-blinded , randomized , placebo-controlled trial enrolling children ( 1 month to 12 years of age ) admitted to a Brazilian PICU and expected to require MV and continuous sedative and analgesic drug infusions for at least five days .
METHODS	Children were randomized to receive either norepinephrine ( NE ) ( 0.15 mcg/kg/min ) or normal saline infusion , started in the first 24 hours of MV , and maintained for 72 hours .
METHODS	We compared hemodynamic variables , fluid intake , renal function and urine output between groups .
RESULTS	Forty children were equally allocated to the NE or placebo groups , with no differences in baseline characteristics , laboratorial findings , PRISM II score , length of MV , or mortality between groups .
RESULTS	The average norepinephrine infusion was 0.143 mcg/kg/min .
RESULTS	The NE group showed higher urine output ( p = 0.016 ) and continuous increment in the mean arterial pressure compared to the baseline ( p = 0.043 ) .
RESULTS	There were no differences in the remaining hemodynamic variables , fluid requirements , or furosemide administration .
CONCLUSIONS	Early norepinephrine infusion in children submitted to MV improves mean arterial pressure and increases urine output .
CONCLUSIONS	These effects were attributed to reversion of vasoplegia induced by the sedative and analgesic drugs .

###24347664
BACKGROUND	Left atrial volume ( LAV ) is an important marker of heart failure ( HF ) severity .
BACKGROUND	We hypothesized that LAV independently correlates with clinical outcomes in patients who receive cardiac resynchronization therapy with a defibrillator ( CRT-D ) and can be used for improved risk assessment in this population .
RESULTS	The benefit of CRT-D versus defibrillator-only therapy in reducing the risk of HF or death was assessed by LAV ( dichotomized at the upper quartile > 52 mL/m2 ) among 1785 patients enrolled in the Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy ( MADIT-CRT ) study .
RESULTS	Landmark analysis was used to evaluate the relationship between LAV response to CRT-D and subsequent clinical outcomes .
RESULTS	Multivariable analysis showed that patients with a higher baseline LAV experienced 69 % ( P < 0.001 ) and 59 % ( P = 0.02 ) increased hazard for HF or death and for all-cause mortality , respectively , independently of baseline left ventricular volume .
RESULTS	CRT-D was associated with a significant reduction in LAV compared with defibrillator-only therapy ( -28 % versus -10 % , respectively ; P < 0.001 ) .
RESULTS	Landmark analysis showed that after CRT-D implantation each 1 % reduction in LAV was independently associated with a corresponding 4 % reduction in the hazard of subsequent HF or death ( P < 0.001 ) .
RESULTS	The assessment of LAV change after CRT implantation improved prediction of clinical response to the device compared with assessment of the corresponding changes in left ventricular volume .
CONCLUSIONS	LAV is an independent correlate of clinical outcomes in mildly symptomatic HF patients treated with CRT-D .
CONCLUSIONS	CRT exerts pronounced reverse remodeling effects on the left atrium that independently correlate with improved clinical outcomes after device implantation .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00180271 .

###25408262
OBJECTIVE	Erlotinib is a drug used to treat non-small cell lung cancer , pancreatic cancer and several other types of cancer .
OBJECTIVE	It is a reversible tyrosine kinase inhibitor that acts on the epidermal growth factor receptor and inhibits cell proliferation , growth , migration , invasion and survival .
OBJECTIVE	This study was performed for the subsequent marketing of a test erlotinib formulation in Korea .
OBJECTIVE	We evaluated the comparative bioavailability and tolerability of the test and reference formulations in healthy adult volunteers .
METHODS	A total of 46 healthy male subjects were enrolled in a single-dose , randomized , open-label , two-period , two-sequence , crossover , bioequivalence study .
METHODS	During each treatment period , subjects received 150 mg of erlotinib in either the test or reference formulation .
METHODS	There was a 2-week washout period between each period .
METHODS	Blood samples were obtained 15 times during each period , before dosing and 0.5 , 1 , 1.5 , 2 , 2.5 , 3 , 4 , 6 , 8 , 12 , 24 , 48 , 72 and 96 h after oral administration .
METHODS	Plasma concentrations of erlotinib were determined using liquid chromatography-tandem mass spectrometry .
METHODS	Pharmacokinetic parameters , including maximum plasma concentration ( C ( max ) ) , area under the plasma concentration-time curve to the last sampling time ( AUC ( t ) ) , AUC from time zero to infinity ( AUC ( ) ) , and time to reach C ( max ) ( t ( max ) ) , were measured , and all treatment-emergent adverse events and their relationships with the study medications were recorded throughout the study .
METHODS	An additional analysis was performed to characterize the association between the cytochrome P450 ( CYP ) 1A1 , CYP1A2 and CYP3A4 genotypes and the erlotinib pharmacokinetic parameters .
RESULTS	A total of 41 subjects completed the study .
RESULTS	There were no significant differences in the prevalence of adverse events between the two formulations , and there were no serious or unexpected adverse events during the study .
RESULTS	Both formulations had very similar C ( max ) , AUC , terminal half-life ( t ) and t ( max ) values .
RESULTS	The 90 % confidence intervals of the geometric least-squares mean ratios of the test to reference formulation were 1.09 ( 0.98-1 .22 ) for C ( max ) and 1.10 ( 1.01-1 .21 ) for AUCt .
RESULTS	Statistical significance was observed between the CYP1A2 * 1M genotype and the erlotinib pharmacokinetic parameter , particularly C ( max ) ( p = 0.015 ) .
CONCLUSIONS	This study suggests that the test and reference formulations of 150 mg erlotinib have similar pharmacokinetic characteristics .
CONCLUSIONS	Both had no major safety issues and were well-tolerated .
CONCLUSIONS	The test formulation met the regulatory criteria for assuming bioequivalence to the reference formulation for both AUCt and C max .
CONCLUSIONS	The additional genetic analysis demonstrated that the major metabolic enzymes of erlotinib did not significantly affect erlotinib metabolism , with the exception of CYP1A2 * 1M .

###24625200
BACKGROUND	Chronic infection with Pseudomonas aeruginosa is associated with an increased exacerbation frequency , a more rapid decline in lung function , and increased mortality in patients with bronchiectasis .
OBJECTIVE	To perform a randomized placebo-controlled study assessing the efficacy and safety of inhaled colistin in patients with bronchiectasis and chronic P. aeruginosa infection .
METHODS	Patients with bronchiectasis and chronic P. aeruginosa infection were enrolled within 21 days of completing a course of antipseudomonal antibiotics for an exacerbation .
METHODS	Participants were randomized to receive colistin ( 1 million IU ; n = 73 ) or placebo ( 0.45 % saline ; n = 71 ) via the I-neb twice a day , for up to 6 months .
RESULTS	The primary endpoint was time to exacerbation .
RESULTS	Secondary endpoints included time to exacerbation based on adherence recorded by the I-neb , P. aeruginosa bacterial density , quality of life , and safety parameters .
RESULTS	All analyses were on the intention-to-treat population .
RESULTS	Median time ( 25 % quartile ) to exacerbation was 165 ( 42 ) versus 111 ( 52 ) days in the colistin and placebo groups , respectively ( P = 0.11 ) .
RESULTS	In adherent patients ( adherence quartiles 2-4 ) , the median time to exacerbation was 168 ( 65 ) versus 103 ( 37 ) days in the colistin and placebo groups , respectively ( P = 0.038 ) .
RESULTS	P. aeruginosa density was reduced after 4 ( P = 0.001 ) and 12 weeks ( P = 0.008 ) and the St. George 's Respiratory Questionnaire total score was improved after 26 weeks ( P = 0.006 ) in the colistin versus placebo patients , respectively .
RESULTS	There were no safety concerns .
CONCLUSIONS	Although the primary endpoint was not reached , this study shows that inhaled colistin is a safe and effective treatment in adherent patients with bronchiectasis and chronic P. aeruginosa infection .
CONCLUSIONS	Clinical trial registered with http://www.isrctn.org/ ( ISRCTN49790596 ) .

###24434748
OBJECTIVE	Rubbing the skin may influence the persistence of pustulosis over time .
OBJECTIVE	The aim of this study was to assess the impact of a new fabric made with fluorine-synthetic fiber in improving plantar pustulosis .
METHODS	A total of 17 patients were randomized to receive on one side a sock made of fluorine-synthetic fiber and on the other a sock made of cotton fabric for 4 weeks .
METHODS	The main outcome was the percentage reduction of lesional area at week 4 .
RESULTS	The median lesion reduction at week 4 was 42.6 % in the fluorine-synthetic fiber arm and 2.7 % in the cotton arm ( p = 0.148 ) .
RESULTS	Among secondary outcomes , the overall reduction over time in the treated areas was significantly in favor of the fluorine-synthetic fiber arm ( p = 0.045 ) as well as the perception of the disease by the patient ( p = 0.025 ) .
CONCLUSIONS	Despite the fact that the primary outcome was not reached , there was a tangible reduction in the extension of the treated areas and in the perception of the disease by the patient .

###24392551
OBJECTIVE	To assess the effectiveness of an educational intervention based on social cognitive theory on increasing consumption of fruit and vegetable among Grade 4 students .
METHODS	The randomised study was conducted in Isfahan , Iran , during 2011 and comprised 138 students , who were randomly divided into intervention and control groups .
METHODS	Data was collected at the beginning and three months after the intervention .
METHODS	A self-administered questionnaire based on constructs of social cognitive theory and food consumption was used .
METHODS	Theory-based nutrition education was imparted on the intervention group .
METHODS	Data was analysed using SPSS 15 and appropriate statistical tests .
RESULTS	The intervention group had 68 ( 49.27 % ) subjects , while there were 70 ( 50.72 % ) controls .
RESULTS	After the intervention , mean scores of behavioural capability ( p < 0.001 ) , self-efficacy in difficult situations ( p = 0.04 ) , self-efficacy in selecting fruits and vegetables ( p = 0.01 ) , social support ( p = 0.03 ) , and observational learning ( p = 0.002 ) had significantly improved in the intervention group .
RESULTS	Nutritional behaviour also showed significant improvement on mean daily intake of fruits and vegetables in the intervention group ( p < 0.001 ) .
CONCLUSIONS	Intervention based on social cognitive theory led to increase in the consumption of fruits and vegetables among students , which confirmed the efficiency of social cognitive theory for such interventions .

###24449169
BACKGROUND	Low-frequency , bilateral stimulation of the subthalamic nucleus can improve axial symptoms of advanced Parkinson 's disease ( PD ) , but it is not particularly effective for segmental symptoms .
METHODS	The optimal contacts for low-frequency ( 60 Hz ) and high-frequency ( 130 Hz ) single monopolar stimulation were determined .
METHODS	Then , in a randomized , double-blind , prospective crossover manner , 60-Hz and 130-Hz stimulations via the respective optimal contacts were compared for immediate efficacy in improving the motor function of patients with PD .
RESULTS	The optimal contacts for 60-Hz stimulation were situated more ventrally than those for 130-Hz stimulation ( P = 0.038 ) .
RESULTS	Under the respective optimal , single monopolar stimulation , 60 Hz provided superior efficacy over 130 Hz in improving the total Unified Parkinson 's Disease Rating Scale motor score ( P < 0.001 ) and the akinesia ( P = 0.011 ) and axial motor signs ( P = 0.012 ) subscores without compromising the therapeutic effect on tremor and rigidity .
CONCLUSIONS	Low-frequency stimulation via the optimal contacts is effective in improving overall motor function of patients with PD .

###24764186
OBJECTIVE	Cesarean delivery is a common surgical procedure with anticipated substantial postoperative pain .
OBJECTIVE	The addition of a transversus abdominis plane block ( TAPB ) to a multimodal analgesic regimen that includes intrathecal morphine may provide improved early pain outcomes and decrease the risk of chronic post-surgical pain .
OBJECTIVE	The purpose of this research was to assess the ability of an ultrasound-guided TAPB with low-dose ropivacaine to decrease early postoperative pain , opioid consumption , and risk of developing persistent pain when compared with a placebo block .
METHODS	Eighty-three women were randomly assigned to either a treatment ( 0.25 % ropivacaine ) or control group ( 0.9 % saline ) in this double-blind trial , and 74 women were included in the final analysis .
METHODS	Ultrasound-guided TAPBs were performed with an injection of 20mL of study solution per side .
METHODS	The primary outcome measures of this study were : pain at rest and pain after movement measured with a numeric rating scale , results of the Quality of Recovery-40 ( QoR-40 ) questionnaire , and opioid consumption at 24 hr .
METHODS	These were used with an a priori sample size calculation to detect a 30 % reduction in pain scores , a 10 % improvement in QoR-40 score , and a 50 % reduction in opioid consumption .
METHODS	Health quality and physical functioning were assessed using the Short Form 36 ( SF-36 ) Health Survey at 30days and six months .
RESULTS	Assessment at 24 hr after Cesarean delivery revealed no clinically important differences between groups in postoperative pain , QoR-40 , or opioid consumption .
RESULTS	There were no clinically important differences between groups regarding measures of nausea , pruritus , vomiting , urine retention ( 2 , 24 , and 48 hr postoperatively ) , 24-hr QoR-40 sub-dimensions , or the SF-36 Health Survey ( 30days and six months postoperatively ) .
CONCLUSIONS	Ultrasound-guided TAPB did not improve postoperative pain , quality of recovery , or opioid consumption 24 hr following surgery .
CONCLUSIONS	Similar health and functioning ( SF-36 ) at 30days and six months were reported by both groups .
CONCLUSIONS	This trial was registered at ClinicalTrials.gov number : NCT01261637 .

###24265128
BACKGROUND	Although the prevalence of congenital malformations is high in China , little information is available on the Hainan Province .
METHODS	Data used in this study were collected from 2000 to 2010 by monitoring newborns ( including both live births and stillbirths ) in the Hainan Province .
METHODS	Comparison analyses were conducted by performing ( 2 ) tests .
RESULTS	The data showed an increasing temporal trend of the birth defect prevalence in the Hainan Province ; however , the rate of birth defects changed over time .
CONCLUSIONS	The Hainan Province is confronted with the challenge to reduce the prevalence of birth defects .
CONCLUSIONS	Interventions should focus on the rural areas where a higher prevalence of birth defects is observed .

###24599770
BACKGROUND	The incidence of Clostridium difficile infection ( CDI ) has risen dramatically during the last decade .
BACKGROUND	Although patients respond well to medical therapy such as vancomycin , 20 % -30 % of patients treated suffer a recurrence of CDI .
METHODS	We developed a simple/practical scoring rule ( logistic regression model ) for recurrent CDI using data from 2 large phase 3 clinical trials .
METHODS	Seventy-seven baseline CDI factors were classified : demographics , comorbidity , medications , vital signs , laboratory tests , severity , and symptoms .
METHODS	Predictors with the highest discrimination in each class ( using receiver operating characteristics curve ) were selected .
METHODS	For the final model , stepwise selection was performed .
METHODS	Discrimination , calibration , and internal validation were used to assess the model .
RESULTS	The final model with a simple scoring rule was developed .
RESULTS	It includes 4 independent risk factors that are readily available when the patient makes initial contact : age ( < 75 vs 75 years ) , number of unformed bowel movements during previous 24 hours ( < 10 vs 10 ) , serum creatinine leves ( < 1.2 mg/dL vs 1.2 mg/dL ) and prior episode of CDI ( yes vs no ) .
RESULTS	In addition , the model includes choice of treatment ( vancomycin or fidaxomicin ) .
CONCLUSIONS	The prediction model for recurrence may be useful for treatment decision .
BACKGROUND	NCT00314951 and NCT00468728 .

###24726166
BACKGROUND	The Occluded Artery Trial ( OAT ) randomized stable patients ( n = 2201 ) > 24 h ( calendar days 3-28 ) after myocardial infarction ( MI ) with totally occluded infarct-related arteries ( IRA ) , to percutaneous coronary intervention ( PCI ) with optimal medical therapy , or optimal medical therapy alone ( MED ) .
BACKGROUND	PCI had no impact on the composite of death , reinfarction , or class IV heart failure over extended follow-up of up to 9 years .
BACKGROUND	We evaluated the impact of early and late reinfarction and definition of MI on subsequent mortality .
RESULTS	Reinfarction was adjudicated according to an adaptation of the 2007 universal definition of MI and the OAT definition ( 2 of the following -- symptoms , EKG and biomarkers ) .
RESULTS	Cox regression models were used to analyze the effect of post-randomization reinfarction and baseline variables on time to death .
RESULTS	After adjustment for baseline characteristics the 169 ( PCI : n = 95 ; MED : n = 74 ) patients who developed reinfarction by the universal definition had a 4.15-fold ( 95 % CI 3.03-5 .69 , p < 0.001 ) increased risk of death compared to patients without reinfarction .
RESULTS	This risk was similar for both treatment groups ( interaction p = 0.26 ) and when MI was defined by the stricter OAT criteria .
RESULTS	Reinfarctions occurring within 6 months of randomization had similar impact on mortality as reinfarctions occurring later , and the impact of reinfarction due to the same IRA and a different epicardial vessel was similar .
CONCLUSIONS	For stable post-MI patients with totally occluded infarct arteries , reinfarction significantly independently increased the risk of death regardless of the initial management strategy ( PCI vs. MED ) , reinfarction definition , location and early or late occurrence .

###25123917
BACKGROUND	Attention-deficit/hyperactivity disorder ( ADHD ) is the most common neurobehavioral disorder of childhood and has often a chronic course persisting into adulthood .
BACKGROUND	However , up to 30 % of children treated with stimulants either fail to show an improvement or suffer adverse side effects , including decreased appetite , insomnia and irritability and there is no evidence of long term efficacy of stimulants for ADHD .
BACKGROUND	A series of studies has shown that neurofeedback is an effective additional or alternative treatment for children with ADHD , leading to e.g. significant and stable improvement in behavior , attention and IQ .
BACKGROUND	Significant treatment effects of neurofeedback have also been verified in meta-analyses .
BACKGROUND	Most of the trials , however , have been criticized for methodological difficulties , particularly lacking appropriate control conditions and number of patients included .
BACKGROUND	This randomized study examines the efficacy of slow cortical potentials ( SCP ) - neurofeedback , controlling unspecific effects of the setting by comparing two active treatment modalities .
METHODS	A total of 144 patients with ADHD , older than six and younger than ten years , in some cases with additional pharmacological treatment , are included in this trial .
METHODS	In five trial centres patients are treated either with SCP-feedback or electromyographic ( EMG ) - feedback in 25 sessions within 3months .
METHODS	A comprehensive test battery is conducted before and after treatment and at follow-up 6month later , to assess core symptoms of ADHD , general psychopathology , attentional performance , comorbid symptoms , intelligence , quality of life and cortical arousal .
CONCLUSIONS	The efficacy of SCP-feedback training for children with ADHD is evaluated in this randomized controlled study .
CONCLUSIONS	In addition to behavior ratings and psychometric tests neurophysiological parameters serve as dependent variables .
CONCLUSIONS	Further , the choice of EMG-biofeedback as an active control condition is debated .
BACKGROUND	Current Controlled Trials ISRCTN76187185 .
BACKGROUND	Registered 5 February 2009 .

###25216771
OBJECTIVE	Medications or lifestyle changes to prevent or improve hypertension often press considerable efforts on patients suffering from mild hypertension .
OBJECTIVE	Capsules including Umezu polyphenols ( UP ) , polyphenols in Japanese plums , may help them to control their blood pressure ( BP ) .
OBJECTIVE	The aim of this study is to evaluate the effectiveness of UP on BP and its safety .
METHODS	A total of 15 healthy workers without antihypertensive medication who had some concerns about their BP , preferably normal-high BP or hypertension level 1 , were randomized in a double-blind manner into UP ingesting and placebo groups .
METHODS	Each subject was instructed to take four capsules daily for 12 weeks ( daily UP dose , 800 mg for the UP ingesting group ; and 0 mg for the placebo group ) .
METHODS	These subjects were followed for 12 weeks , and their BP both at home and at the examination site , as well as self-perceived quality-of-life outcomes and possible side effects , was monitored during that period .
METHODS	Group time interactions on BP changes were examined .
RESULTS	All of the 15 subjects completed the 12-week intervention trial .
RESULTS	The BP changes did not significantly differ between the UP ingesting and placebo groups , neither at the examination site nor at home .
RESULTS	But during the study period , no adverse effects were observed .
CONCLUSIONS	No remarkable effect of UP on BP was observed .
CONCLUSIONS	However , a higher dose of UP was confirmed safe and high in adherence in this 12-week randomized controlled trial .
CONCLUSIONS	Its effect on BP and other outcomes shall be confirmed in a larger sample .

###26118148
OBJECTIVE	The purpose of our study was two-fold : 1 ) adapt and test a social support measure specific to the experiences of African American women with type 2 diabetes mellitus ( T2DM ) ; 2 ) examine its relationship to psychosocial measures .
METHODS	200 rural African American women with uncontrolled T2DM participating in a randomized controlled trial completed surveys at baseline on their social support , empowerment , self-care , self-efficacy , depression and diabetes distress .
METHODS	Exploratory factor analysis and correlation analysis were conducted to test the psychometric properties of the Dunst Family Support Scale adapted for AA women with T2DM ( FSS-AA T2DM ) and its relationship with other psychosocial measures .
RESULTS	The 16 items of the FSS-AA T2DM loaded onto three distinct factors : parent and spouse/partner support , community and medical support , and extended family and friends support .
RESULTS	Reliability for the entire scale was good ( Cronbach 's = .90 ) and was acceptable to high across these three factors ( Cronbach 's of .86 , .83 , and .83 respectively ) .
RESULTS	All three factors were significantly correlated with self-reported empowerment , self-care , self-efficacy , depression and diabetes distress , although the pattern was different for each factor .
RESULTS	FSS-AA-T2DM showed good concurrent validity when compared with similar items on the Diabetes Distress Scale .
CONCLUSIONS	The FSS-AA T2DM , a 16-item scale measuring social support among rural African American women with T2DM , is internally consistent and reliable .
CONCLUSIONS	Findings support the utility of this screening tool in this population , although additional testing is needed with other groups in additional settings .

###25916131
OBJECTIVE	To study the influence of laser radiation on the parameters of microcirculation in patients with gastroesophageal reflux disease ( GERD ) .
METHODS	The examined 112 patients with GERD aged 19 to 79 years .
METHODS	78 patients were given a ten-day course of intravenous laser therapy , which was conducted with the help of the apparatus of laser therapy `` matrix-vlok '' ( produced by `` the matrix '' , Russia ) with wavelength 0,405 microns , the radiation power at the output of the main fiber 1-1 ,5 mW , continuous mode radiation .
METHODS	The studied parameters were determined before and after treatment .
RESULTS	The obtained data testify to the improvement of microcirculation in patients with GERD under the influence of laser therapy .

###24533697
OBJECTIVE	Signs and symptoms of Cushing 's disease are associated with high burden of illness .
OBJECTIVE	In this analysis , we evaluated the effect of pasireotide treatment on signs and symptoms in patients with Cushing 's disease .
METHODS	Phase III study with double-blind randomization of two pasireotide doses .
METHODS	Patients ( n = 162 ) with persistent/recurrent or de novo Cushing 's disease and urinary free cortisol ( UFC ) levels 15 upper limit of normal ( ULN ) were randomized to receive subcutaneous pasireotide ( 600/900 g bid ) .
METHODS	At month 3 , patients with UFC 2 ULN and not exceeding the baseline value continued their randomized dose ; all others received 300 g bid uptitration .
METHODS	At month 6 , patients could enter an open-label phase until month 12 with a maximal dose of 1200 g bid .
METHODS	Changes in signs and symptoms of hypercortisolism over 12 months ' treatment in patients still enroled in the study and with evaluable measurements were assessed in relation to degree of UFC control .
RESULTS	Reductions in blood pressure were observed even without full UFC control and were greatest in patients who did not receive antihypertensive medications during the study .
RESULTS	Significant reductions in total cholesterol and low-density lipoprotein ( LDL ) - cholesterol were observed in patients who achieved UFC control .
RESULTS	Reductions in BMI , weight and waist circumference occurred during the study even without full UFC control .
RESULTS	Adverse effects were typical of somatostatin analogues except for hyperglycaemia-related events , which were experienced by 728 % of patients .
CONCLUSIONS	In the largest Phase III study of medical therapy in Cushing 's disease , significant improvements in signs and symptoms were seen during 12 months of pasireotide treatment , as UFC levels decreased .

###24445367
OBJECTIVE	Tenofovir disoproxil fumarate ( TDF ) has been associated with renal insufficiency .
OBJECTIVE	Co-administration with boosted protease inhibitors , which increases its exposure , may further increase the risk of renal insufficiency .
METHODS	We compared the incidence of renal events among women taking TDF co-administered with lopinavir/ritonavir ( LPV/r ) versus those co-administering TDF with nevirapine ( NVP ) .
METHODS	Renal events were defined as a confirmed drop in creatinine clearance associated with a serum creatinine grade 2 or higher , or that leading to treatment modification .
RESULTS	Overall , 741 HIV-infected women were enrolled into the study .
RESULTS	Of these , 24 ( 3.2 % ) had reportable renal events ( 18 in LPV/r arm , six in NVP arm ) .
RESULTS	In multivariate analysis , renal events were significantly associated with the LPV/r arm [ odds ratio ( OR ) 3.12 , 95 % confidence interval ( CI ) 1.21 , 8.05 ; P = 0.019 ] , baseline HIV-1 RNA ( OR 2.65 , 95 % CI 1.23 , 5.69 per 1 log10 copies/ml higher ; P = 0.013 ) and baseline creatinine clearance ( OR 0.83 , 95 % CI 0.70-0 .98 per 10 ml/min higher ; P = 0.030 ) .
RESULTS	In multivariate analysis evaluating renal events requiring treatment modification , only baseline HIV-1 RNA and creatinine clearance were significantly associated ( OR 4.41 , 95 % CI 1.65 , 11.78 per 1 log10 copies/ml higher ; P = 0.003 and OR 0.80 , 95 % CI 0.64 , 0.99 per 10 ml/min higher ; P = 0.040 , respectively ) .
CONCLUSIONS	The rates of renal events were relatively low in the two treatment arms .
CONCLUSIONS	However , patients taking TDF co-administered with LPV/r had significantly more renal events compared to those co-administered with NVP .
CONCLUSIONS	Furthermore , higher baseline HIV RNA and lower creatinine clearance were associated with the development of renal insufficiency requiring treatment modification .

###24906545
BACKGROUND	The aim of this study was to evaluate the safety , feasibility and preliminary effects of a high-intensity rehabilitative task-oriented circuit training ( TOCT ) in a sample of multiple sclerosis ( MS ) subjects on walking competency , mobility , fatigue and health-related quality of life ( HRQoL ) .
METHODS	24 MS subjects ( EDSS 4.890.54 , 17 female and 7 male , 52.5811.21 years , MS duration 15.218.68 years ) have been enrolled and randomly assigned to 2 treatment groups : ( i ) experimental group received 10 TOCT sessions over 2 weeks ( 2 hours/each session ) followed by a 3 months home exercise program , whereas control group did not receive any specific rehabilitation intervention .
METHODS	A feasibility patient-reported questionnaire was administered after TOCT .
METHODS	Functional outcome measures were : walking endurance ( Six Minute Walk Test ) , gait speed ( 10 Meter Walk Test ) , mobility ( Timed Up and Go test ) and balance ( Dynamic Gait Index ) .
METHODS	Furthermore , self-reported questionnaire of motor fatigue ( Fatigue Severity Scale ) , walking ability ( Multiple Sclerosis Walking Scale - 12 ) and health-related quality of life ( Multiple Sclerosis Impact Scale - 29 ) were included .
METHODS	Subjects ' assessments were delivered at baseline ( T0 ) , after TOCT ( T1 ) and 3 months of home-based exercise program ( T2 ) .
RESULTS	After TOCT subjects reported a positive global rating on the received treatment .
RESULTS	At 3 months , we found a 58.33 % of adherence to the home-exercise program .
RESULTS	After TOCT , walking ability and health-related quality of life were improved ( p < 0.05 ) with minor retention after 3 months .
RESULTS	The control group showed no significant changes in any variables .
CONCLUSIONS	This two weeks high-intensity task-oriented circuit class training followed by a three months home-based exercise program seems feasible and safe in MS people with moderate mobility impairments ; moreover it might improve walking abilities .
BACKGROUND	NCT01464749 .

###25747677
OBJECTIVE	To evaluate the safety and efficacy of a supraciliary micro-stent ( CyPass Micro-Stent ; Transcend Medical , Menlo Park , California , USA ) for surgical treatment of glaucoma in patients refractory to topical medications .
METHODS	Multicenter , single-arm interventional study .
METHODS	Patients with open-angle glaucoma ( Shaffer Grade 3 and 4 ) and uncontrolled medicated intraocular pressure ( IOP ) > 21mm Hg at baseline and candidates for conventional glaucoma surgery were enrolled .
METHODS	Glaucoma medications were discontinued at surgery and resumed at investigator discretion .
METHODS	CyPass Micro-Stent implantation was completed in all patients using a standard clear corneal approach .
METHODS	Adverse events , postoperative IOP changes , and need for IOP-lowering medications during the first 12 postoperative months ( 12M ) were monitored .
RESULTS	Sixty-five eyes were enrolled , and 55 were available at 12M , accounting for loss to follow-up and early termination .
RESULTS	Baseline IOP was 24.5 2.8 mm Hg , and the mean number of medications recorded was 2.2 1.1 .
RESULTS	There were no serious intraoperative events or major adverse events ( eg , retinal or choroidal detachment , persistent uveitis , persistent hyphema , hypotony maculopathy ) .
RESULTS	The most common adverse events included IOP increases > 30mm Hg beyond 1month ( 11 % , 7/65 ) , transient hyphema ( 6 % , 4/65 ) , and cataract progression ( 12 % , 5/41 phakic eyes ) .
RESULTS	Mean IOP was 16.4 5.5 mm Hg at 12months-a 34.7 % reduction ( P < .0001 ) .
RESULTS	Mean medication usage also decreased from baseline to a mean of 1.4 1.3 medications at 12M ( P = .002 ) .
RESULTS	In eyes originally indicated for conventional glaucoma surgery , no secondary surgery was performed in 83 % ( 53/64 ) .
CONCLUSIONS	Supraciliary stenting with the CyPass Micro-Stent effectively lowers IOP as a surgical treatment for glaucoma , precluding the need for more invasive glaucoma surgery in > 80 % of patients at 1 year , therebyreducing postoperative glaucoma surgical complications .

###25159126
OBJECTIVE	We evaluated the outcome of person-centred and integrated Palliative advanced home caRE and heart FailurE caRe ( PREFER ) with regard to patient symptoms , health-related quality of life ( HQRL ) , and hospitalizations compared with usual care .
RESULTS	From January 2011 to October 2012 , 36 ( 26 males , 10 females , mean age 81.9 years ) patients with chronic heart failure ( NYHA class III-IV ) were randomized to PREFER and 36 ( 25 males , 11 females , mean age 76.6 years ) to the control group at a single centre .
RESULTS	Prospective assessments were made at 1 , 3 , and 6 months using the Edmonton Symptom Assessment Scale , Euro Qol , Kansas City Cardiomyopathy Questionnaire , and rehospitalizations .
RESULTS	Between-group analysis revealed that patients receiving PREFER had improved HRQL compared with controls ( 57.619.2 vs. 48.524.4 , age-adjusted P-value = 0.05 ) .
RESULTS	Within-group analysis revealed a 26 % improvement in the PREFER group for HRQL ( P = 0.046 ) compared with 3 % ( P = 0.82 ) in the control group .
RESULTS	Nausea was improved in the PREFER group ( 2.42.7 vs. 1.71.7 , P = 0.02 ) , and total symptom burden , self-efficacy , and quality of life improved by 18 % ( P = 0.035 ) , 17 % ( P = 0.041 ) , and 24 % ( P = 0.047 ) , respectively .
RESULTS	NYHA class improved in 11 of the 28 ( 39 % ) PREFER patients compared with 3 of the 29 ( 10 % ) control patients ( P = 0.015 ) .
RESULTS	Fifteen rehospitalizations ( 103days ) occurred in the PREFER group , compared with 53 ( 305days ) in the control group .
CONCLUSIONS	Person-centred care combined with active heart failure and palliative care at home has the potential to improve quality of life and morbidity substantially in patients with severe chronic heart failure .
BACKGROUND	NCT01304381 .

###24641790
BACKGROUND	The practice of traditional Chinese medicine ( TCM ) has a profound history in many Asian countries .
BACKGROUND	TCM syndrome is a set of characteristic physical signs and symptoms shared by a group of patients .
BACKGROUND	Syndrome diagnosis and treatment assignment according to the identified TCM syndrome is a long-held practice of Chinese medicine .
BACKGROUND	Owing to its distinctive way of interpreting illness and administering care , medical practitioners not well educated in TCM theories and practices are generally incapable of giving out prescriptions for Chinese patent drugs .
BACKGROUND	Currently , the existence of a multitude of Chinese patent drugs marked with largely identical indications is further complicating this situation .
METHODS	In this multicenter , randomized , controlled , double-blind , double-dummy clinical trial , in which we will use the comparative effectiveness research method , we will compare the efficacy of two commonly used Chinese patent medicines for angina patients diagnosed with qi deficiency and blood stasis syndrome .
METHODS	A total of 160 patients will be recruited and randomly assigned to receive either ( 1 ) QiShenYiQi dripping pills , Tongxinluo placebo and routine medication or ( 2 ) Tongxinluo capsules , QiShenYiQi placebo and routine medication .
METHODS	These treatment regimens will be carried out for 4weeks , followed by a 10-day washout period and a 4-week crossover phase in which the treatments in the two patient groups will be exchanged .
METHODS	Patients will be allowed to choose symptoms that matter most to them and will be grouped accordingly .
METHODS	Patient-reported outcomes such as the Seattle Angina Questionnaire score and the 15-point Likert scale score will be measured and reported .
METHODS	The minimally clinical important difference will be calculated and used for efficacy assessment , and correspondence analysis will be performed to identify the best indications for each drug .
CONCLUSIONS	The goal of the study is to establish a methodology for the precise identification of the characteristic indications for which a Chinese patent drug is most effective .
CONCLUSIONS	The findings of this study will inform the practicality of the proposed evaluation method .
BACKGROUND	Chinese clinical trials register Chi CTRTTRCC13003732 .

###25295436
OBJECTIVE	Patients with anxious depression are typically more difficult to treat with monoaminergic antidepressants compared to those with nonanxious depression .
OBJECTIVE	Although novel research has shown that the N-methyl-D-aspartate ( NMDA ) receptor antagonist ketamine has rapidly acting , relatively sustained effects in treating depression , we predicted that , consistent with the existent literature on traditional antidepressants , patients with anxious depression would have a poorer antidepressant response .
METHODS	Twenty-six inpatients with treatment-resistant major depressive disorder ( MDD ) ( DSM-IV criteria ) received a single infusion of ketamine ( 0.5 mg/kg over 40 minutes ) from January 2006-March 2013 and were followed for 28 days .
METHODS	A post hoc analysis compared treatment response and relapse using the Montgomery-Asberg Depression Rating Scale ( MADRS ) in patients with anxious versus nonanxious depression .
METHODS	Anxious depression was defined as MDD plus a Hamilton Depression Rating Scale anxiety/somatization factor score 7 .
RESULTS	Both anxious and nonanxious depressed patients responded positively to ketamine .
RESULTS	A linear mixed model controlling for baseline with the MADRS revealed a significant group main effect ( P = .03 ) and group-by-time interaction ( P = .01 ) .
RESULTS	Post hoc tests indicated that patients with anxious depression had significantly fewer depression symptoms compared to those with nonanxious depression at days 1 through 5 , 9 through 12 , 15 through 17 , and 25 , with no significant group differences in dissociative ( P = .62 ) or psychotic ( P = .41 ) side effects .
RESULTS	Regarding responders , patients with anxious depression relapsed significantly later than those with nonanxious depression ( median SE = 19.0 17.9 vs 1.0 0.0 days to relapse , respectively ; = 9.30 ; P = .002 ) .
CONCLUSIONS	Unexpectedly , patients with anxious depression responded better to ketamine than those with nonanxious depression , with longer time to relapse and no side effect differences .
CONCLUSIONS	This finding gives promise for the role of novel glutamatergic medications for the treatment of those with anxious depression , a traditionally difficult-to-treat subgroup of depressed patients .
BACKGROUND	ClinicalTrials.gov identifier : NCT00088699 .

###24347521
OBJECTIVE	To perform a deterministic cost-utility analysis , from a 1-year societal perspective , of two treatment programs for stress urinary incontinence ( SUI ) without face-to-face contact : one Internet-based and one sent by post .
OBJECTIVE	The treatments were compared with each other and with no treatment .
METHODS	We performed this economic evaluation alongside a randomized controlled trial .
METHODS	The study included 250 women aged 18-70 , with SUI1time/week , who were randomized to 3 months of pelvic floor muscle training via either an Internet-based program including e-mail support from an urotherapist ( n = 124 ) or a program sent by post ( n = 126 ) .
METHODS	Recruitment was web-based , and participants were self-assessed with validated questionnaires and 2-day bladder diaries , supplemented by a telephone interview with a urotherapist .
METHODS	Treatment costs were continuously registered .
METHODS	Data on participants ' time for training , incontinence aids , and laundry were collected at baseline , 4 months , and 1 year .
METHODS	We also measured quality of life with the condition-specific questionnaire ICIQ-LUTSqol , and calculated the quality-adjusted life-years ( QALYs ) gained .
METHODS	Baseline data remained unchanged for the no treatment option .
METHODS	Sensitivity analysis was performed .
RESULTS	Compared to the postal program , the extra cost per QALY for the Internet-based program ranged from 200 to 7,253 , indicating greater QALY-gains at similar or slightly higher costs .
RESULTS	Compared to no treatment , the extra cost per QALY for the Internet-based program ranged from 10,022 to 38,921 , indicating greater QALY-gains at higher , but probably acceptable costs .
CONCLUSIONS	An Internet-based treatment for SUI is a new , cost-effective treatment alternative .

###26198928
BACKGROUND	Vitamin D has immunomodulatory effects in multiple sclerosis ( MS ) .
BACKGROUND	Vitamin D acts through various mechanisms such as secretion of cytokines .
BACKGROUND	Interleukin-17 ( IL-17 ) is a critical interleukin in inflammatory response in MS.
OBJECTIVE	This study assessed the effect of oral high dose vitamin D intake on IL-17 levels in MS patients in a double blind randomized clinical trial .
METHODS	94 patients with a diagnosis of relapsing remitting multiple sclerosis ( RRMS ) were randomized to two groups .
METHODS	One group received 50,000 IU vitamin D3 every five days for 12weeks .
METHODS	The other group was given placebo .
METHODS	Both groups received interferon - ( IFN - ) treatment .
METHODS	Serum levels of IL-17 were measured at the beginning of the study and after 12weeks .
RESULTS	IL-17 serum levels were 56.7528.72 pg/ml and 30.3175.85 pg/ml in the intervention and placebo group at the beginning of the study , respectively ( MedianIQR , p = 0.338 ) .
RESULTS	After 12weeks , IL-17 levels were 58.9367.93 pg/ml and 46.1394.70 pg/ml in the intervention and placebo group , respectively ( MedianIQR , p = 0.960 ) .
RESULTS	The multiple linear regression analysis indicated that the consumption of vitamin D3 was positively and significantly associated with the logarithm of IL-17 measures ( = 1.719 ; p = 0.002 and R2 = 0.91 ) , adjusted by EDSS scores .
CONCLUSIONS	IL-17 levels showed significant change in RRMS patients after receiving high dose vitamin D3 for 12weeks .

###25326519
OBJECTIVE	To assess the efficacy of securing conjunctival autograft ( CAG ) without glue or sutures , using the patient 's own blood at the surgical site , and to compare it with the current accepted standard of using fibrin glue for graft adherence , in pterygium surgery .
METHODS	A single-centre , prospective , randomised controlled trial was carried out in 200 eyes of patients with primary pterygia who were advised pterygium excision with CAG .
METHODS	Enrolled participants were assigned to Group I or II by randomisation .
METHODS	After excision of pterygium , they underwent CAG with autologous blood in Group I ( 100 eyes ) and CAG with fibrin glue in Group II ( 100 eyes ) .
METHODS	During follow-up of 1 year , the eyes were assessed for graft adherence and recurrence .
RESULTS	Of the 200 eyes randomised , 6 eyes that did not complete intended follow-up were excluded from final analysis .
RESULTS	Of the 194 eyes ( Group I n = 96 , Group II n = 98 ) , on the first postoperative day , 3 eyes in Group I ( 3.13 % ) had total graft dislodgement requiring regrafting from another site or reattachment with glue .
RESULTS	In Group II also 2 eyes ( 2.04 % ) had graft dislodgement on the first postoperative day requiring regrafting from another site .
RESULTS	During the 1-year follow-up , 6 eyes in Group I ( 6.25 % ) and 8 eyes in Group II ( 8.16 % ) developed recurrence .
CONCLUSIONS	Feasibilty of adherence of the graft without glue in pterygium surgery is promising and has results comparable with the fibrin glue technique in terms of long-term outcome and recurrence , suggesting the potential for autologous blood to replace fibrin glue in graft fixation .
BACKGROUND	Clinical Trial Registry , India : CTRI/2013/06 / 003764 and UTN : U1111-1140-6572 .

###24280470
OBJECTIVE	The physiological changes that occur during pregnancy , including increased blood volume and cardiac output , can affect hemodynamic control , most profoundly with positional changes that affect venous return to the heart .
OBJECTIVE	By using Osteopathic Manipulative Treatment ( OMT ) , a body-based modality theorized to affect somatic structures related to nervous and circulatory systems , we hypothesized that OMT acutely improves both autonomic and hemodynamic control during head-up tilt and heel raise in women at 30 weeks gestation .
METHODS	One hundred subjects were recruited at 30 weeks gestation .
METHODS	The obstetric clinics of UNTHealth in Fort Worth , TX .
METHODS	Subjects were randomized into one of three treatment groups : OMT , placebo ultrasound , or time control .
METHODS	Ninety subjects had complete data ( N = 25 , 31 and 34 in each group respectively ) .
METHODS	Blood pressure and heart rate were recorded during 5 min of head-up tilt followed by 4 min of intermittent heel raising .
RESULTS	No significant differences in blood pressure , heart rate or heart rate variability were observed between groups with tilt before or after treatment ( p > 0.36 ) , and heart rate variability was not different between treatment groups ( p > 0.55 ) .
RESULTS	However , blood pressure increased significantly ( p = 0.02 ) and heart rate decreased ( p < 0.01 ) during heel raise after OMT compared to placebo or time control .
CONCLUSIONS	These data suggest that OMT can acutely improve hemodynamic control during engagement of the skeletal muscle pump and this was most likely due to improvement of structural restrictions to venous return .

###24774721
BACKGROUND	Chordomas are relatively rare lesions of the bones .
BACKGROUND	About 30 % occur in the sacrococcygeal region .
BACKGROUND	Surgical resection is still the standard treatment .
BACKGROUND	Due to the size , proximity to neurovascular structures and the complex anatomy of the pelvis , a complete resection with adequate safety margin is difficult to perform .
BACKGROUND	A radical resection with safety margins often leads to the loss of bladder and rectal function as well as motoric/sensoric dysfunction .
BACKGROUND	The recurrence rate after surgery alone is comparatively high , such that adjuvant radiation therapy is very important for improving local control rates .
BACKGROUND	Proton therapy is still the international standard in the treatment of chordomas .
BACKGROUND	High-LET beams such as carbon ions theoretically offer biologic advantages in slow-growing tumors .
BACKGROUND	Data of a Japanese study of patients with unresectable sacral chordoma showed comparable high control rates after hypofractionated carbon ion therapy only .
METHODS	This clinical study is a prospective randomized , monocentric phase II trial .
METHODS	Patients with histologically confirmed sacrococcygeal chordoma will be randomized to either proton or carbon ion radiation therapy stratified regarding the clinical target volume .
METHODS	Target volume delineation will be carried out based on CT and MRI data .
METHODS	In each arm the PTV will receive 64 GyE in 16 fractions .
METHODS	The primary objective of this trial is safety and feasibility of hypofractionated irradiation in patients with sacrococygeal chordoma using protons or carbon ions in raster scan technique for primary or additive treatment after R2 resection .
METHODS	The evaluation is therefore based on the proportion of treatments without Grade 3-5 toxicity ( CTCAE , version 4.0 ) up to 12 months after treatment and/or discontinuation of the treatment for any reason as primary endpoint .
METHODS	Local-progression free survival , overall survival and quality of life will be analyzed as secondary end points .
CONCLUSIONS	The aim of this study is to confirm the toxicity results of the Japanese data in raster scan technique and to compare it with the toxicity analysis of proton therapy given in the same fractionation .
CONCLUSIONS	Using this data , a further randomized phase III trial is planned , comparing hypofractionated proton and carbon ion irradiation .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01811394 .

###25074436
BACKGROUND	Alterations in the advanced glycation end-products ( AGE ) - receptor of AGE ( RAGE ) system are linked to several chronic diseases , which may result from vascular damage .
BACKGROUND	A high circulating level of the pro-inflammatory RAGE-ligand S100A12 , also known as EN-RAGE , is thought to promote while a high level of soluble RAGE ( sRAGE ) is thought to protect against development of atherosclerotic cardiovascular disease ( CVD ) .
BACKGROUND	We evaluated circulating S100A12 and sRAGE in relation to clinical characteristics , nutritional status , inflammation and mortality risk in chronic kidney disease ( CKD ) Stage 5 patients starting on dialysis .
METHODS	Plasma S100A12 and sRAGE , biomarkers of inflammation and nutritional status , and comorbidities were investigated in 200 CKD Stage 5 patients [ median age of 56 years , 62 % men and median glomerular filtration rate ( GFR ) of 6.2 mL/min/1 .73 m ( 2 ) ] in conjunction with initiation of dialysis therapy .
METHODS	Associations between mortality risk and S100A12 or sRAGE were assessed after a median follow-up period of 23 months .
METHODS	In addition , for comparative analyses , S100A12 and sRAGE levels were assessed also in 58 haemodialysis and 78 peritoneal dialysis patients after 1 year of dialysis , 56 CKD Stages 3-4 patients and 50 community-based control subjects .
RESULTS	The median level of S100A12 was 4-fold higher , median sRAGE 2.4 higher and median ratio S100A12/sRAGE 2.27 times higher in CKD 5 patients than in controls .
RESULTS	Similar alterations were observed in CKD 3-4 patients ; however , CKD 5 patients had a higher median level of sRAGE than the CKD 3-4 patients .
RESULTS	In the CKD 5 patients , S100A12 levels were higher in those with diabetes or CVD than in those without these comorbidities .
RESULTS	Furthermore , S100A12 correlated with high-sensitivity C-reactive protein ( hsCRP ) levels ( = 0.53 ; P < 0.001 ) and a 1-SD higher level of S100A12 associated with increased all-cause mortality risk ( hazard ratio 1.32 , 95 % confidence interval 1.01-1 .73 ) after adjustment for age , sex , comorbidity , nutritional status and inflammation ( hsCRP ) .
RESULTS	In the CKD 5 patients , sRAGE correlated negatively with GFR ( = -0.26 ; P < 0.01 ) but sRAGE did not associate with hsCRP , comorbidities or mortality .
CONCLUSIONS	Plasma concentrations of sRAGE , S100A12 and the ratio S100A12/sRAGE , are markedly elevated in CKD 5 patients starting on dialysis as well as in CKD 3-4 patients and prevalent dialysis patients suggesting that these alterations are typical for patients with moderate or severe CKD .
CONCLUSIONS	In CKD 5 patients , an increased concentration of S100A12 are associated with inflammation , comorbidities and increased mortality risk whereas no such associations were observed for sRAGE .
CONCLUSIONS	These results suggest that while high plasma S100A12 is an independent predictor of increased mortality risk , sRAGE does not seem to be a valid risk marker in this patient population .

###25077715
OBJECTIVE	In this study we sought to determine whether a Titin peptide fragment can serve as a clinical biomarker for changes in muscle mass .
METHODS	Mass spectrometry was used to identify Titin fragment in urine .
METHODS	An antibody against this Titin sequence was raised and used to develop a competitive ELISA assay for measurement in serum .
METHODS	Rat tissue extractions in the presence or absence of a series of proteases of interest were used to identify its enzymatic origin .
METHODS	A rat model of dexamethasone ( DEX ) induced muscle atrophy and a human 56-day bed rest study with and without vibration therapy were used to assess biological and clinical relevance .
RESULTS	A technically robust ELISA measuring the Titin fragment was developed against a Titin peptide fragment identified in human urine .
RESULTS	The fragment was shown to be produced primarily by MMP-2 cleavage of Titin .
RESULTS	In the rat muscle DEX induced atrophy model , Titin-MMP2 fragment was decreased in the beginning of DEX treatment , and then significantly increased later on during DEX administration .
RESULTS	In the human bed rest study , the Titin-MMP2 fragment was initially decreased 11.9 ( 3.7 ) % after 1day of bed rest , and then gradually increased ending up at a 16.4 ( 4.6 ) % increase at day 47 .
CONCLUSIONS	We developed a robust ELISA measuring a muscle derived MMP-2 generated Titin degradation fragment in rat and human serum .
CONCLUSIONS	Importantly , the fragment can be measured in serum and that these levels are related to induction of skeletal muscle atrophy .

###24302608
BACKGROUND	This study compared the effects of short-term titrated colestilan ( a novel non-absorbable , non-calcium , phosphate binder ) with placebo , and evaluated the safety and efficacy of colestilan over 1 year compared with sevelamer , in patients with chronic kidney disease ( CKD ) 5D .
METHODS	This prospective multicentre study comprised a 4-week phosphate binder washout period , a 16-week short-term , flexible-dose , treatment period ( including a 4-week placebo-controlled withdrawal period ) and a 40-week extension treatment phase .
RESULTS	At Week 16 ( the end of the 4-week placebo-controlled withdrawal period ) , serum phosphorus level was 0.43 mmol/L ( 1.32 mg/dL ) lower with colestilan than placebo ( P < 0.001 ; primary end point ) .
RESULTS	Serum LDL-C level was also lower with colestilan than with placebo ( P < 0.001 ) .
RESULTS	Both colestilan and sevelamer produced significant reductions from baseline in serum phosphorus levels ( P < 0.001 ) , maintained for 1 year , and the proportion of patients achieving target levels of 1.78 mmol/L ( 5.5 mg/dL ) or 1.95 mmol/L ( 6.0 mg/dL ) at study end were similar ( 65.3 and 73.3 % , respectively , for colestilan , and 66.9 and 77.4 % , respectively , for sevelamer ) .
RESULTS	Serum calcium level remained stable in the colestilan group but tended to increase slightly in the sevelamer group ( end-of-study increase of 0.035 mmol/L over baseline ) .
RESULTS	Both binders produced similar reductions from baseline in LDL-C level ( P < 0.001 ) , and responder rates after 1 year , using a target of < 1.83 mmol/L ( 70 mg/dL ) or < 2.59 mmol/L ( 100 mg/dL ) were similar in both groups ( 50.7 and 85.3 % for colestilan and 54.0 and 80.6 % for sevelamer ) .
RESULTS	Colestilan was generally well tolerated .
CONCLUSIONS	Colestilan is effective and safe for the treatment of hyperphosphataemia in patients with CKD 5D , and affords similar long-term phosphorus and cholesterol reductions/responder rates to sevelamer .

###24991815
OBJECTIVE	We investigated the association of HIV infection and highly active antiretroviral therapy ( HAART ) with sleep disordered breathing ( SDB ) , fatigue , and sleepiness .
METHODS	HIV-uninfected men ( HIV - ; n = 60 ) , HIV-infected men using HAART ( HIV + / HAART + ; n = 58 ) , and HIV-infected men not using HAART ( HIV + / HAART - ; n = 41 ) recruited from two sites of the Multicenter AIDS cohort study ( MACS ) underwent a nocturnal sleep study , anthropometric assessment , and questionnaires for fatigue and the Epworth Sleepiness Scale .
METHODS	The prevalence of SDB in HIV - men was compared to that in men matched from the Sleep Heart Health Study ( SHHS ) .
RESULTS	The prevalence of SDB was unexpectedly high in all groups : 86.7 % for HIV - , 70.7 % for HIV + / HAART + , and 73.2 % for HIV + / HAART - , despite lower body-mass indices ( BMI ) in HIV + groups .
RESULTS	The higher prevalence in the HIV - men was significant in univariate analyses but not after adjustment for BMI and other variables .
RESULTS	SDB was significantly more common in HIV - men in this study than those in SHHS , and was common in participants with BMIs < 25 kg/m2 .
RESULTS	HIV + men reported fatigue more frequently than HIV - men ( 25.5 % vs. 6.7 % ; p = 0.003 ) , but self-reported sleepiness did not differ among the three groups .
RESULTS	Sleepiness , but not fatigue , was significantly associated with SDB .
CONCLUSIONS	SDB was highly prevalent in HIV - and HIV + men , despite a normal or slightly elevated BMI .
CONCLUSIONS	The high rate of SDB in men who have sex with men deserves further investigation .
CONCLUSIONS	Sleepiness , but not fatigue , was related to the presence of SDB .
CONCLUSIONS	Clinicians caring for HIV-infected patients should distinguish between fatigue and sleepiness when considering those at risk for SDB , especially in non-obese men .

###24954607
OBJECTIVE	To compare the efficacy of percutaneous sodium tetradecyl sulfate ( STS ) injection with ethanol injection in the treatment of benign nonfunctioning thyroid nodules .
METHODS	This prospective study included 47 patients with 50 benign thyroid nodules .
METHODS	The lesions were randomly assigned into two groups : 20 in the ethanol arm and 30 in the STS arm .
METHODS	The mean lesion volume was 25.6 mL 28.5 ( range , 4-122 .1 mL ) in the ethanol arm and 25.4 mL 27 ( range , 0.72-129 mL ) in the STS arm .
METHODS	One sitting of sclerosant injection was done in 20 lesions , and two injections , three injections , four injections , five injections , six injections , seven injections , and eight sittings of injections were done in 9 lesions , 4 lesions , 8 lesions , 4 lesions , 2 lesions , 2 lesions , and 1 lesion .
METHODS	The mean volumes of the instilled ethanol and STS were 5.3 mL and 7.8 mL , respectively , per sitting .
METHODS	Follow-up sonography was performed at 1 , 3 , 6 , and 12 months after the procedure .
RESULTS	The final 12-month follow-up lesion volumes were 4.1 mL 3.7 ( range , 0.3-15 .2 mL ) in the ethanol group and 4.4 mL 5.8 ( range , 0.01-29 .6 mL ) in the STS group ( P = .85 ) .
RESULTS	The mean volume reduction was 84 % and 82.8 % in the two groups .
RESULTS	No significant adverse effects were seen in either of the two groups .
CONCLUSIONS	Sonographically guided percutaneous ethanol and STS injections are not significantly different from each other in terms of the volume reduction achieved in benign nonfunctioning thyroid nodules .

###25079864
OBJECTIVE	Parathyroid hormone ( PTH ) promotes calcium reabsorption in the cortical distal nephron ( CDN ) .
OBJECTIVE	The phosphate concentration ( [ P ] f ) rises in that segment in chronic kidney disease ( CKD ) ; in theory , high [ P ] f could reduce availability of calcium for reabsorption and necessitate a compensatory rise in [ PTH ] .
OBJECTIVE	With assumptions , [ P ] f is proportional to phosphate excreted/volume of filtrate ( EP/GFR ) .
OBJECTIVE	We therefore hypothesized that [ PTH ] would correlate with EP/GFR in CKD , and PTH ] would correlate with EP/GFR after sevelamer therapy .
METHODS	We conducted a 4-week , placebo-controlled trial of sevelamer carbonate in patients with CKD .
METHODS	[ PTH ] 1-84 and parameters of phosphate homeostasis were measured before and after treatment .
METHODS	GFR was assumed to equal creatinine clearance ( Ccr ) .
METHODS	Pertinent linear regressions were performed .
RESULTS	Phosphate excretion fell in the sevelamer group only .
RESULTS	Decrements in [ PTH ] with sevelamer differed from increments with placebo .
RESULTS	With either treatment , [ PTH ] correlated with EP/Ccr and PTH ] correlated with EP/Ccr .
RESULTS	Changes in [ PTH ] were minimal in some sevelamer recipients despite reductions in EP/Ccr ; calcium excreted/volume of filtrate was low in these subjects .
CONCLUSIONS	Phosphate influx affected [ PTH ] in CKD by determining [ P ] f in the CDN .
CONCLUSIONS	In some patients , low calcium influx may have blunted the effect of sevelamer on [ PTH ] .

###24516951
OBJECTIVE	In a previous uncontrolled experiment , oral vancomycin improved the symptoms ( S ) of chronic constipation ( CC ) .
OBJECTIVE	The aim of this 21 day controlled pilot study was to determine if a low lincomycin dose improved the S of CC patients unresponsive to a high fiber diet .
METHODS	On days 0-to-10 , patients were randomized to 500 mg oral lincomycin + high fiber ( L + F ) or to placebo + high fiber ( P + F ) .
METHODS	Participants and patients were blinded .
METHODS	From days 10-to-21 , patients were continued solely on the high fiber diet .
METHODS	The primary efficacy endpoint was the difference in S between L + F and P + F from days 0-to-21 using a visual analog scale ( VAS ) calibrated from 0 = severe S to 10 = asymptomatic .
RESULTS	The means of all S were significantly improved by L + F but not by P + F.
RESULTS	A significant higher proportion of L + F patients increased the VAS > or = 3 points .
CONCLUSIONS	The initial course of L facilitated the effect of F probably by its effect on the colon flora .
CONCLUSIONS	This sequence of flora-altering biologics + F may serve as model to replace chronic use of drugs .

###24376277
BACKGROUND	We explored the differential effect of cessation interventions ( behavioral support sessions with [ BSS + ] and without [ BSS ] bupropion ) between hookah and cigarette smokers .
METHODS	We reanalyzed the data from a major cluster-randomized controlled trial , ASSIST ( Action to Stop Smoking In Suspected Tuberculosis ) , which consisted of 3 conditions : ( a ) behavioral support sessions ( BSS ) , ( b ) behavioral support sessions plus 7 weeks of bupropion therapy ( BSS + ) , and ( c ) controls receiving usual care .
METHODS	The trial originally recruited 1,955 adult smokers with suspected tuberculosis from 33 health centers in the Jhang and Sargodha districts of Pakistan between 2010 and 2011 .
METHODS	The primary endpoint was continuous 6-month smoking abstinence , which was determined by carbon monoxide levels .
METHODS	Subgroup-specific relative risks ( RRs ) of smoking abstinence were computed and tested for differential intervention effect using log binomial regression ( generalized linear model ) between 3 subgroups ( cigarette-only : 1,255 ; mixed : 485 ; and hookah-only : 215 ) .
RESULTS	The test result for homogeneity of intervention effects between the smoking forms was statistically significant ( p-value for BSS + : .04 and for BSS : .02 ) .
RESULTS	Compared to the control , both interventions appeared to be effective among hookah smokers ( RR = 2.5 ; 95 % CI = 1.3-4 .7 and RR = 2.2 ; 95 % CI = 1.3-3 .8 , respectively ) but less effective among cigarette smokers ( RR = 6.6 ; 95 % CI = 4.6-9 .6 and RR = 5.8 ; 95 % CI = 4.0-8 .5 ) , respectively .
CONCLUSIONS	The differential intervention effects on hookah and cigarette smokers were seen ( a ) because the behavioral support intervention was designed primarily for cigarette smokers ; ( b ) because of differences in demographic characteristics , behavioral , and sociocultural determinants ; or ( c ) because of differences in nicotine dependency levels between the 2 groups .

###25102684
OBJECTIVE	To observe the effect of the Traditional Chinese Medicine , modified Taohongsiwu decoction , versus pyridoxine on patients with hand-foot syndrome ( HFS ) from capecitabine , sorafenib , and gefitinib chemotherapy for gastric , lung , breast , colon , or rectal cancer .
OBJECTIVE	Also , to compare quality of life of patients in each group .
METHODS	Patients were assigned randomly to group A or B. Group A was given modified Taohongsiwu decoction to soak hands and feet for 30 min , once daily .
METHODS	Group B was given 100 mg pyridoxine orally , twice daily .
METHODS	After a 2-week treatment , the therapeutic effect was assessed by observing three major symptoms , including pain , ulceration , and muscular atrophy .
METHODS	This was assessed with the HFS-14 questionnaire .
RESULTS	Significant differences were observed between the two groups in pain relief , and improvement of daily life , walking , and interpersonal communication ( P < 0.01 ) .
RESULTS	No significant differences in driving ability or interpersonal relationships were found .
RESULTS	After 2 weeks , the effective rate was 88.3 % in group A , which was significantly higher than the 50 % in group B ( P = 0.00 ) .
CONCLUSIONS	Modified Taohongsiwu decoction is effective in the treatment of patients with HFS .
CONCLUSIONS	It improves patients ' quality of life according to the HFS-14 .

###25522565
OBJECTIVE	To evaluate the preemptive analgesia effects of both the parecoxib sodium and the pentazocine in patients undergoing nasal endoscopic surgery .
METHODS	In the randomized , double blind , controlled study , 120 patients undergoing septoplasty were divided into 3 groups ( n = 40 ) : group A received parecoxib 40 mg by muscle injection 30 min before the operation ; group B received pentazocine 30 mg ; group C received an equal volume of saline .
METHODS	The preemptive analgesia effect was evaluated with VAS scores which recorded at different time points .
METHODS	The proportion of participants using rescue analgesia after the operation were recorded as additional measures of preemptive analgesia .
RESULTS	Intra-operative as well as the postoperative pain scores were less in the group A and group B than in the control group .
RESULTS	Fewer participants required rescue medication after operation with parecoxib as well as pentazocine than placebo .
RESULTS	However there were no difference in the preemptive effects between the group A and group B.
CONCLUSIONS	Administration of both the parecoxib and pentazocine before the nasal endoscopic surgery can provide preemptive analgesia without serious adverse side effects that deserves popularization in the clinic .

###24287689
OBJECTIVE	A recent phase III randomized controlled trial ( NCT00434148 ) showed efficacy of pasireotide in the treatment of patients with Cushing 's disease ( CD ) .
OBJECTIVE	Patients were invited to participate in an extension phase of the protocol and a subgroup had a sustained response .
OBJECTIVE	We report the experience with 4 patients in our center of which 2 full responders have completed 5.5 and 4.25 years of treatment with disease control .
METHODS	The trial protocol was described previously .
METHODS	The extension phase consisted of 3-monthly visits with clinical , biochemical , and imaging evaluation and investigator-driven pasireotide titration .
METHODS	Research charts were retrospectively analyzed .
RESULTS	Four patients with persistent CD following pituitary surgery completed the first 6 months of the trial and 3 continued in the next 6 month open-label phase .
RESULTS	Two patients with baseline urinary free cortisol ( UFC ) 5.3-6 .7 times the upper limit of normal had a rapid sustained response to pasireotide and entered the extension phase after 12 months .
RESULTS	They remain in clinical and biochemical disease remission and 1 patient now only requires 300 g daily of pasireotide .
RESULTS	All 4 patients developed glucose intolerance ; however , the two patients in the extension phase were eventually able to discontinue all diabetes pharmacotherapy .
RESULTS	Adverse events included second degree atrioventicular block type 1 without QT prolongation in a patient with pre-existing sinus bradycardia , and symptomatic cholelithiasis requiring cholecystectomy in a second patient .
CONCLUSIONS	Pasireotide therapy can provide normalization of UFC and of clinical symptoms and signs of CD during up to 5 years of follow-up .
CONCLUSIONS	This study demonstrates the possible recuperation of normoglycemia after continued use of pasireotide and control of underlying hypercortisolemia .
CONCLUSIONS	Longer-term monitoring for potential adverse events related to continued use of pasireotide is indicated .

###25182454
BACKGROUND	Low molecular weight heparins ( LMWHs ) constitute the mainstay of anticoagulant therapy for pediatric venous thromboembolism ( VTE ) .
BACKGROUND	The safety and effectiveness of dalteparin , an LMWH , has not been established in children , and pediatric data on dalteparin for VTE are limited to one single-center experience .
OBJECTIVE	To establish dose-finding ( primary endpoint ) and efficacy/safety outcomes ( secondary endpoints ) in children treated with dalteparin in a substudy of the Kids-DOTT trial .
METHODS	A prospective multicenter trial using dalteparin subcutaneously twice daily for acute VTE in children aged 21 years was conducted under an investigator-held Investigational New Drug application registered with the US Food and Drug Administration .
METHODS	Initial weight-based dosing per protocol was as follows : infants ( < 12 months ) , 150 IU kg ( -1 ) ; children ( 1-12 years ) , 125 IU kg ( -1 ) ; and adolescents ( 13-18 years ) , 100 IU kg ( -1 ) .
METHODS	Bleeding events were categorized according to ISTH criteria .
METHODS	Descriptive non-parametric statistics were employed for all analyses .
RESULTS	Eighteen patients ( 67 % male ) were enrolled from January 2010 to October 2013 across four centers .
RESULTS	No supratherapeutic levels were observed .
RESULTS	Median ( range ) therapeutic doses by age group were as follows : infants ( n = 3 ) , 180 IU kg ( -1 ) ( 146-181 IU kg ( -1 ) ) ; children ( n = 7 ) , 125 IU kg ( -1 ) ( 101-175 IU kg ( -1 ) ) ; and adolescents ( n = 8 ) , 100 IU kg ( -1 ) ( 91-163 IU kg ( -1 ) ) .
RESULTS	The median duration of dalteparin use was 48 days ( range : 2-169 days ) , and the median follow-up was 10.5 months ( range : 2-35 months ) .
RESULTS	There were no related serious adverse events , no clinically relevant bleeding events , and no symptomatic recurrent VTEs .
CONCLUSIONS	Dalteparin successfully achieved targeted anti-factor Xa levels in 18 children and young adults with acute VTE with a standardized age-based dosing regimen , with a favorable safety and efficacy profile .

###24666558
BACKGROUND	Pulmonary rehabilitation has been demonstrated to improve exercise capacity , dyspnoea , quality of life and to reduce the adverse effects of acute exacerbations .
BACKGROUND	Current guidelines recommend exercise training in patients with mild to very severe disease .
BACKGROUND	However , there is insufficient data comparing the efficacy of different training approaches and intensities .
METHODS	Between January 2009 and December 2012 , 105 COPD patients were screened to participate in the study .
METHODS	61 patients were randomly assigned into an individualized training group or into a non-individualized training group .
METHODS	Both groups exercised once a week for 60minutes over a time period of three months .
METHODS	At the beginning and after three months , the following measurements were performed : 6-minute walking test ( 6-MWT ) , health-related quality of life ( St. Georges Respiratory Questionnaire ; SGRQ and COPD-Assessment-Test ; CAT ) , M. rectus femoris cross-sectional area , and inflammatory markers in peripheral blood .
RESULTS	Only in the individualized training group we observed a significant change of the 6-MWT ( increase of 32.47 m ; p = 0.012 ) and the cross-sectional area of the M. rectus fermoris ( increase of 0.57 cm2 ; p = 0.049 ) , while no significant changes occurred in the non-individualized training group .
RESULTS	Peroxisome-proliferator-activated receptor - coactivator 1 increased in the individualized training only after the three months training period ( increase of 0.43 relative copies ; p = 0.017 ) , all other myokines and inflammatory markers were not influenced by either of the programs .
RESULTS	The total drop-out-rate was 44.3 % .
CONCLUSIONS	A low frequency outpatient training program may induce modest improvements in exercise capacity and muscle mass only if it is performed on an individualized basis .

###25493316
OBJECTIVE	To determine the DA and cost-effectiveness of the dermoscope in primary care for skin lesions suspected of malignancy .
METHODS	In a cluster randomized clinical trial , 48 Dutch general practices were randomized to either intervention group using a dermoscope or control group using only naked-eye examination .
METHODS	A total of 194 lesions from 170 patients in the intervention group and 222 lesions from 211 patients in the control group were analysed for DA and cost-effectiveness .
RESULTS	The percentage of correctly diagnosed lesions in intervention group and control group was 50.5 % and 40.5 % respectively .
RESULTS	This was 61.5 % and 22.2 % for melanomas .
RESULTS	In the intervention group , three malignancies were treated with the expectative treatment option compared to none in the control group .
RESULTS	The odds ratio ( OR ) of a correct diagnosis in the intervention group , compared to control group , was 1.51 ( 95 % CI : 0.962.37 ) P = 0.07 .
RESULTS	Consequently , the relative risk was 1.25 .
RESULTS	The incremental cost-effectiveness ratio was 89 ( 95 % CI 60 to 598 ) , indicating that using a dermoscope costs an additional 89 for one additional correctly diagnosed patient .
RESULTS	Additional analyses showed better effects of dermoscopy compared to the control group for 98 % of the bootstrap resamples .
CONCLUSIONS	The probability of a correct diagnosis was 1.25 times higher using a dermoscope than without a dermoscope .
CONCLUSIONS	Although this difference is marginally not statistically significant , dermoscopy in general practice appears to be cost effective .
CONCLUSIONS	We therefore think that GPs should be trained to use a dermoscope , although they should realize that even with the use of a dermoscope not all lesions will be diagnosed correctly .

###24742658
OBJECTIVE	Elevated polyclonal serum immunoglobulin free light chains ( FLCs ; combined FLC+FLC [ cFLC ] ) are associated with adverse clinical outcomes and increased mortality ; we investigated cFLC and cardiovascular disease ( CVD ) events in type 2 diabetes .
METHODS	In a cohort study of 352 south Asian patients with type 2 diabetes , serum cFLC , high-sensitivity C-reactive protein ( hsCRP ) , and standard biochemistry were measured .
METHODS	CVD events over 2 years were recorded and assessed using multiple logistic regression .
RESULTS	cFLC levels were elevated significantly in 29 of 352 ( 8 % ) patients with CVD events during 2 years of follow-up ( 50.7 vs. 42.8 mg/L ; P = 0.004 ) .
RESULTS	In multivariate analysis , elevated cFLC ( > 57.2 mg/L ) was associated with CVD outcomes ( odds ratio 3.3 [ 95 % CI 1.3-8 .2 ] ; P = 0.012 ) and remained significant after adjusting for age , albumin-to-creatinine ratio , diabetes duration , or treatment .
CONCLUSIONS	cFLC elevation is a novel marker for CVD outcomes in type 2 diabetes that warrants further investigation .

###25397803
OBJECTIVE	The aim of this study was to evaluate the survival and success of screw-retained versus cement-retained implant restorations in immediately loaded implants at 8-year follow-up .
METHODS	Patients who were scheduled for full-arch ceramic prosthetic restorations were divided into two groups by randomization : in one group , prosthetic frameworks were screwed onto implants ( screw-retained group , SRG ) , and in the second group , the frameworks were cemented on abutments ( cement-retained group , CRG ) .
METHODS	Dental implants were placed both in postextraction and in healed sites .
METHODS	A temporary full-arch prosthesis was placed immediately after implant placement .
METHODS	Intraoral digital radiographic examinations ( evaluating marginal bone levels ) were made at baseline , 6 months , and each year after implant placement .
RESULTS	In 28 patients , 24 full arches and 192 implants were placed in the maxilla and 10 full arches and 80 implants in the mandible ( 17 rehabilitations in each group ) .
RESULTS	After an 8-year follow-up period , a survival rate of 99.27 % was reported for all implants .
RESULTS	Within the first year after implant placement , bone loss was recorded as follows : the CRG showed mean bone levels of -1.23 0.45 mm , while the SRG showed mean bone levels of -1.01 0.33 mm .
RESULTS	After a 3-year follow-up , a slight increase was found ( 0.30 0.25 mm in CRG and 0.45 0.29 mm in SRG ) .
RESULTS	After that point , marginal bone levels remained stable over time , up to the 8-year follow-up .
RESULTS	No statistically significant differences were found between groups ( P > .05 ) .
CONCLUSIONS	Definitive cement - and screw-retained ceramic restorations are highly predictable , biocompatible , and esthetically pleasing , and the two groups presented no statistically significant differences in bone loss .

###24735420
BACKGROUND	Social anxiety disorder ( SAD ) is one of the most common mental disorders and causes subjective suffering and economic burden worldwide .
BACKGROUND	Although effective treatments are available , a lot of cases go untreated .
BACKGROUND	Internet-based self-help is a low-threshold and flexible treatment alternative for SAD .
BACKGROUND	Various studies have already shown that internet-based self-help can be effective to reduce social phobic symptoms significantly .
BACKGROUND	Most of the interventions tested include therapist support , whereas the role of peer support within internet-based self-help has not yet been fully understood .
BACKGROUND	There is evidence suggesting that patients ' mutual exchange via integrated discussion forums can increase the efficacy of internet-based treatments .
BACKGROUND	This study aims at investigating the added value of therapist-guided group support on the treatment outcome of internet-based self-help for SAD .
METHODS	The study is conducted as a randomized controlled trial .
METHODS	A total of 150 adults with a diagnosis of SAD are randomly assigned to either a waiting-list control group or one of the active conditions .
METHODS	The participants in the two active conditions use the same internet-based self-help program , either with individual support by a psychologist or therapist-guided group support .
METHODS	In the group guided condition , participants can communicate with each other via an integrated , protected discussion forum .
METHODS	Subjects are recruited via topic related websites and links ; diagnostic status will be assessed with a telephone interview .
METHODS	The primary outcome variables are symptoms of SAD and diagnostic status after the intervention .
METHODS	Secondary endpoints are general symptomology , depression , quality of life , as well as the primary outcome variables 6 months later .
METHODS	Furthermore , process variables such as group processes , the change in symptoms and working alliance will be studied .
CONCLUSIONS	The results of this study should indicate whether group-guided support could enhance the efficacy of an internet-based self-help treatment for SAD .
CONCLUSIONS	This novel treatment format , if shown effective , could represent a cost-effective option and could further be modified to treat other conditions , as well .
BACKGROUND	ISRCTN75894275 .

###24793004
OBJECTIVE	This study aimed to test the feasibility of implementing a psychoeducational intervention program for gynecological cancer patients .
METHODS	A single-blinded randomized controlled trial and mixed-method design were used .
METHODS	Study subjects were newly diagnosed gynecological cancer patients with surgery as the first-line treatment .
METHODS	They were randomly assigned to the intervention group , in which a psychoeducational intervention program based on a thematic counseling model was offered , or to the attention control group .
METHODS	Quantitative data on sexual functioning , quality of life , uncertainty , anxiety , depression and social support were collected at recruitment , post-operative and during the in-hospital period , and eight weeks after the operation .
METHODS	Participants in the intervention group and three nurses working in the clinical setting were invited to have semi-structured interviews .
RESULTS	Of the 30 eligible subjects , 26 were successfully recruited into the study .
RESULTS	Following the psychoeducational intervention program , there was significant improvement in the level of inconsistent information about the illness within the category of uncertainty among participants in the intervention group .
RESULTS	In addition , trends towards improvement were demonstrated in quality of life , uncertainty , depression and perceived social support with the provision of the interventions .
RESULTS	Qualitative data indicated the interventions were desired and appreciated by the participants , as well as being feasible and practical to implement in Hong Kong clinical settings .
CONCLUSIONS	The findings suggest that it is feasible to deliver the psychoeducational intervention program and it may have beneficial effects in gynecological cancer patients .
CONCLUSIONS	A full-scale study is warranted to confirm the results .

###24814043
OBJECTIVE	The objectives of this study were ( 1 ) to investigate the effect of nurse training on the use of potentially harmful medications ; and ( 2 ) to explore the effect of nurse training on residents ' health-related quality of life ( HRQoL ) , health service utilization , and mortality .
METHODS	A randomized controlled trial .
METHODS	In total , 227 residents in 20 wards of assisted living facilities in Helsinki were recruited .
METHODS	The 20 wards were randomized into those in which ( 1 ) staff received two 4-hour training sessions on appropriate medication treatment ( intervention group ) , and ( 2 ) staff received no additional training and continued to provide routine care ( control group ) .
METHODS	Two 4-hour interactive training sessions for nursing staff based on constructive learning theory to recognize potentially harmful medications and corresponding adverse drug events .
METHODS	Use of potentially harmful medications , HRQoL assessed using the 15 dimensional instrument of health-related quality of life , health service utilization , and mortality assessed at baseline , and 6 and 12 months .
RESULTS	During the 12-month follow-up , the mean number of potentially harmful medications decreased in the intervention wards [ -0.43 , 95 % confidence interval ( CI ) -0.71 to -0.15 ] but remained constant in the control wards ( +0.11 , 95 % CI -0.09 to +0.31 ) ( P = .004 , adjusted for age , sex , and comorbidities ) .
RESULTS	HRQoL declined more slowly in the intervention wards ( -0.038 ( 95 % CI -0.054 to -0.022 ) than in the control wards ( -0.072 ( 95 % CI -0.089 to -0.055 ) ( P = .005 , adjusted for age , sex , and comorbidities ) .
RESULTS	Residents of the intervention wards had significantly less hospital days ( 1.4 days/person/year , 95 % CI 1.2-1 .6 ) than in the control wards ( 2.3 days/person/year ; 95 % CI 2.1-2 .7 ) ( relative risk 0.60 , 95 % CI 0.49-0 .75 , P < .001 , adjusted for age , sex , and comorbidities ) .
CONCLUSIONS	Activating learning methods directed at nurses in charge of comprehensive care can reduce the use of harmful medications , maintain HRQoL , and reduce hospitalization in residents of assisted living facilities .

###25527657
BACKGROUND	Nontargeted metabolite profiling allows for concomitant examination of a wide range of metabolite species , elucidating the metabolic alterations caused by dietary interventions .
OBJECTIVE	The aim of the current study was to investigate the effects of dietary modifications on the basis of increasing consumption of whole grains , fatty fish , and bilberries on plasma metabolite profiles to identify applicable biomarkers for dietary intake and endogenous metabolism .
METHODS	Metabolite profiling analysis was performed on fasting plasma samples collected in a 12-wk parallel-group intervention with 106 participants with features of metabolic syndrome who were randomly assigned to 3 dietary interventions : 1 ) whole-grain products , fatty fish , and bilberries [ healthy diet ( HD ) ] ; 2 ) a whole-grain-enriched diet with the same grain products as in the HD intervention but with no change in fish or berry consumption ; and 3 ) refined-wheat breads and restrictions on fish and berries ( control diet ) .
METHODS	In addition , correlation analyses were conducted with the food intake data to define the food items correlating with the biomarker candidates .
RESULTS	Nontargeted metabolite profiling showed marked differences in fasting plasma after the intervention diets compared with the control diet .
RESULTS	In both intervention groups , a significant increase was observed in 2 signals identified as glucuronidated alk ( en ) - ylresorcinols [ corrected P value ( Pcorr ) < 0.05 ] , which correlated strongly with the intake of whole-grain products ( r = 0.63 , P < 0.001 ) .
RESULTS	In addition , the HD intervention increased the signals for furan fatty acids [ 3-carboxy-4-methyl-5-propyl-2-furanpropionic acid ( CMPF ) ] , hippuric acid , and various lipid species incorporating polyunsaturated fatty acids ( Pcorr < 0.05 ) .
RESULTS	In particular , plasma CMPF correlated strongly with the intake of fish ( r = 0.47 , P < 0.001 ) but not with intakes of any other foods .
CONCLUSIONS	Novel biomarkers of the intake of health-beneficial food items included in the Nordic diet were identified by the metabolite profiling of fasting plasma and confirmed by the correlation analyses with dietary records .
CONCLUSIONS	The one with the most potential was CMPF , which was shown to be a highly specific biomarker for fatty fish intake .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT00573781 .

###25440307
OBJECTIVE	Previous studies have found that family-based psychosocial treatments are effective adjuncts to pharmacotherapy among adults and adolescents with bipolar disorder ( BD ) .
OBJECTIVE	The objective of this study was to compare the efficacy of adjunctive child - and family-focused cognitive-behavioral therapy ( CFF-CBT ) to psychotherapy as usual ( control ) for mood symptom severity and global functioning in children with BD .
METHODS	Sixty-nine youth , aged 7 to 13 years ( mean = 9.19 , SD = 1.61 ) with DSM-IV-TR bipolar I , II , or not otherwise specified ( NOS ) disorder were randomly assigned to CFF-CBT or control groups .
METHODS	Both treatments consisted of 12 weekly sessions followed by 6 monthly booster sessions delivered over a total of 9months .
METHODS	Independent evaluators assessed participants at baseline , week 4 , week 8 , week 12 ( posttreatment ) , and week 39 ( 6-month follow-up ) .
RESULTS	Participants in CFF-CBT attended more sessions , were less likely to drop out , and reported greater satisfaction with treatment than controls .
RESULTS	CFF-CBT demonstrated efficacy compared to the control treatment in reducing parent-reported mania at posttreatment and depression symptoms at posttreatment and follow-up .
RESULTS	Global functioning did not differ at posttreatment but was higher among CFF-CBT participants at follow-up .
CONCLUSIONS	CFF-CBT may be efficacious in reducing acute mood symptoms and improving long-term psychosocial functioning among children with BD .

###25893930
BACKGROUND	Antioxidants effectiveness in prostate cancer ( PCa ) chemoprevention has been severely questioned , especially after the recent results of the Selenium and Vitamin E Cancer Prevention Trial .
BACKGROUND	We present the results of a double-blind randomized controlled trial ( dbRCT ) on the pharmacokinetic , clinical , and molecular activity of dietary supplements containing lycopene , selenium , and green tea catechins ( GTCs ) in men with multifocal high grade prostatic intraepithelial neoplasia ( mHGPIN ) and/or atypical small acinar proliferation ( ASAP ) .
METHODS	From 2009 to 2014 , we conducted a dbRCT including 60 patients with primary mHGPIN and/or ASAP receiving daily lycopene 35mg , selenium 55g , and GTCs 600mg , or placebo for 6 months .
METHODS	Pharmacokinetic analysis were performed with UV-Visible spectrophotometric assay under standard ( SC ) and accelerated ( AC ) conditions .
METHODS	Upon plasma lycopene concentrations falling within the expected range ( 1.2-90mcg / l ) and no side-effects of grade > 1 , study proceeded to phase II ( n = 50 ) .
METHODS	After unblinding of results , eight men ( 4 per arm , 2 without and 2 with PCa , respectively ) were randomly selected and totRNA extracted from `` non-pathological '' tissues .
METHODS	MicroRNA profiling was performed with the Agilent platform .
METHODS	Raw data processing used R-statistical language and linear models for microarray analysis .
RESULTS	Samples were stable except for lycopene , showing significant degradation ( SC = 56 % , AC = 59 % ) and consequently stabilized under vacuum in a dark packaging .
RESULTS	Mean plasmatic lycopene concentration was 1,450,4 M.
RESULTS	At 6 months , 53 men underwent re-biopsy and 13 ( 24.5 % ) were diagnosed with PCa ( supplementation n = 10 , placebo n = 3 [ P = 0.053 ] ) .
RESULTS	At a mean 37 months follow-up , 3 additional PCa were found in the placebo group .
RESULTS	No significant variations in PSA , IPSS , and PR25 questionnaires were observed .
RESULTS	Stronger modulation of miRNAs was present on re-biopsy in the supplementation group compared to the placebo , including : ( i ) overexpression of miRNAs present in PCa versus non-cancer tissue ; ( ii ) underexpression of miRNAs suppressing PCa proliferation ; ( iii ) detection of 35 miRNAs in PCa patients versus disease-free men , including androgen-regulated miR-125b-5p and PTEN-targeting miR-92a-3p ( both upregulated ) .
CONCLUSIONS	Administration of high doses of lycopene , GTCs , and selenium in men harboring HGPIN and/or ASAP was associated with a higher incidence of PCa at re-biopsy and expression of microRNAs implicated in PCa progression at molecular analysis .
CONCLUSIONS	The use of these supplements should be avoided .

###24387916
OBJECTIVE	Diabetes self-management education ( DSME ) is recommended for all patients with diabetes .
OBJECTIVE	Current estimates indicate that < 50 % of patients receive DSME , increasing risk for hospitalization which occurs more frequently with diabetes .
OBJECTIVE	Hospitalization presents opportunities to provide DSME , potentially decreasing readmissions .
OBJECTIVE	To address this , we investigated the feasibility of providing DSME to inpatients with diabetes .
METHODS	Patients hospitalized on four medicine units were randomized to receive DSME ( Education Group ) ( n = 9 ) prescribed by a certified diabetes educator and delivered by a registered nurse , or Usual Care ( n = 12 ) .
METHODS	Participants completed Diabetes Knowledge Tests ( DKT ) , Medical Outcomes Short Form ( SF-36 ) , Diabetes Treatment Satisfaction Questionnaire ( DTSQ ) , and the DTSQ-inpatient ( DTSQ-IP ) .
METHODS	Bedside capillary blood glucoses ( CBG ) on day of admission , randomization and discharge were compared .
RESULTS	There were no group differences in demographics , diabetes treatment , admission CBG ( 18693 mg/dL vs. 21984 mg/dL , p = 0.40 ) , DKT scores ( Education vs. Usual Care 4825 vs. 6819 , p = 0.09 ) , SF-36 , and DTSQ scores ( 286 vs. 257 , p = 0.41 ) .
RESULTS	Patients receiving education reported more satisfaction with inpatient treatment ( 8313 vs. 6519 , p = 0.03 ) , less hyperglycemia prior to ( 2.74.5 vs. 4.51.4 , p = 0.03 ) and during hospitalization ( 3.91.9 vs. 5.51.2 , p = 0.04 ) ; and had lower mean discharge CBG ( 15938 mg/dL vs. 21167 mg/dL , p = 0.02 ) .
CONCLUSIONS	Inpatient diabetes education has potential to improve treatment satisfaction , and reduce CBG .

###24433061
BACKGROUND	A direct renin inhibitor ( DRI ) , aliskiren , may be effective for blood pressure ( BP ) control in hemodialysis patients .
BACKGROUND	However , it is unclear whether aliskiren has a greater beneficial effect on BP and humoral factors than angiotensin II receptor antagonists ( ARBs ) in hypertensive patients on hemodialysis .
METHODS	Eighteen hemodialysis patients ( 58 14 years ) on the recommended dose of an ARB were prospectively randomized into two groups : ARB and DRI groups .
METHODS	Patients in the ARB group continued taking their previous ARB , whereas those in the DRI group switched to aliskiren ( 150 mg/day ) for 12 weeks .
METHODS	Baseline measurements of BP and humoral factors such as plasma renin activity ( PRA ) , plasma aldosterone concentration ( PAC ) and brain natriuretic peptide ( BNP ) were performed .
METHODS	Measurements were repeated every 4 weeks .
RESULTS	At baseline , no differences were observed in age , gender or BP between the two groups .
RESULTS	Systolic BP was unaffected by treatment in either groups ( group effect , p = 0.26 ; time effect , p = 0.38 ; group time effect , p = 0.24 ) .
RESULTS	PRA decreased in DRI ( p 0.02 , group effect , p = 0.65 ; time effect , p = 0.13 ; group time effect , p = 0.048 ) , but not in ARB ( p 0.94 ) .
RESULTS	PAC increased only in DRI ( p 0.03 ) , whereas BNP was unaffected in either group .
CONCLUSIONS	Aliskiren at a dose of 150 mg/day had a similar effect on BP compared with ARBs , but significantly lowered PRA .

###24867512
BACKGROUND	Irritable bowel syndrome ( IBS ) is a chronic gastrointestinal ( GI ) disorder that affects 15-20 % of the Western population .
BACKGROUND	There are currently few therapeutic options available for the treatment of IBS .
BACKGROUND	The aim of this study is to evaluate the efficacy and the safety of a medical device containing a combination of Simethicone and Bacillus coagulans in the treatment of IBS .
METHODS	This is a monocentric double-blind , placebo-controlled parallel group clinical trial .
METHODS	Adult subjects suffering from IBS as defined by Rome III criteria were enrolled .
METHODS	Bloating , discomfort , abdominal pain were assessed as primary end point .
METHODS	Subjects received the active treatment or placebo 3 time a day after each meal for 4 weeks of study period .
METHODS	Subjects were submitted to visit at Day 0 ( T1 ) , at Days 14 ( T2 ) and 29 ( T3 ) .
RESULTS	Fifty-two patients were included into the study .
RESULTS	Intragroup analysis showed a significant reduction of the bloating , discomfort and pain in Colinox group ( CG ) compared to placebo group ( PG ) .
RESULTS	Between group analysis confirmed , at T1-T3 , significant differences between CG and PG in bloating and discomfort .
CONCLUSIONS	Simethicone is an inert antifoaming able to reduce bloating , abdominal discomfort .
CONCLUSIONS	Literature offers increasing evidence linking alterations in the gastrointestinal microbiota and IBS and it is well known that probiotics are important to restore the native gut microbiota .
CONCLUSIONS	The Colinox medical device is specifically targeted against most intrusive symptom of IBS ( bloating ) and it is also able to counteract the most accredited ethiopathogenetic factor in IBS ( alterations of intestinal microbiota ) .
CONCLUSIONS	This is the first randomized double-blind placebo-controlled clinical trial demonstrating the efficacy and safety of a combination of simethicone and Bacillus coagulans in treatment of IBS .

###25116461
BACKGROUND	It is widely agreed that chronic depression is difficult to treat , knowledge about optimal treatment approaches is emerging .
METHODS	A multisite randomized controlled trial was conducted comparing the cognitive behavioral analysis system of psychotherapy ( CBASP ) , a psychotherapy model developed specifically to treat chronic depression ( n = 67 ) with care as usual ( CAU ; evidence-based treatments , n = 72 ) over a period of 52 weeks , with 23 sessions on average , in 3 outpatient clinics in the Netherlands .
METHODS	In both arms algorithm-based pharmacotherapy was provided .
METHODS	Patients ( aged 18-65 ) met criteria for a DSM-IV diagnosis of major depressive disorder with diagnostic specifiers ( chronic , without interepisode recovery ) or with co-occurring dysthymic disorder indicating a chronic course .
METHODS	The Inventory for Depressive Symptomatology ( IDS ) Self-Report was used as the primary outcome measure .
METHODS	Mixed-effects linear regression analysis was used to compare the changes on the IDS scores between CBASP and CAU .
METHODS	The IDS was administered before treatment , and after 8 , 16 , 32 and 52 weeks .
RESULTS	At week 52 , patients assigned to CBASP had a greater reduction of depressive symptoms compared to patients assigned to CAU ( t = -2.00 , p = 0.05 ) .
RESULTS	However , CBASP and CAU did not differ from each other on the IDS after 8 weeks ( t = 0.49 , p = 0.63 ) , 16 weeks ( t = -0.03 , p = 0.98 ) and 32 weeks ( t = -0.17 , p = 0.86 ) of treatment .
CONCLUSIONS	This trial shows that CBASP is at least as effective as standard evidence-based treatments for chronic depression .
CONCLUSIONS	In the long run , CBASP appears to have an added effect .

###26158167
OBJECTIVE	To evaluate feasibility and superiority of large liver hemangioma treated with laparoscopic microwave ablation .
METHODS	Between March 2006 and May 2013 , 47 patients with liver hemangioma ( 5-10 cm ) were surgically treated in our department , and were randomly divided into three groups , laparoscopic microwave ablation group ( treatment group ) , traditional opening group , and laparoscopic resection group .
METHODS	Three groups were compared in respect of postoperative ambulation time , gastrointestinal function recovery time , postoperative liver function recovery time , intraoperative blood loss , postoperative hospital stay , using SPSS13 .0 software and analysis of variance , P < 0.05 indicates significant , then adopting Student-Newman-Keuls method to compare mean value of every two groups .
METHODS	And the treatment group of patients were tracked and reviewed .
RESULTS	With regard to above aspects , treatment group and two control groups were compared , P < 0.05 was considered statistically significant , then the result of S-N-K method showed that the treatment group was far better than the control group in the above four areas , however compared with traditional opening group laparoscopic resection group did not demonstrate any superiority .
RESULTS	Tracking the patients of treatment group proved no recurrence , and one case 's CT films before and after surgery were compared , further confirming the feasibility of microwave ablation .
CONCLUSIONS	To large hepatic hemangioma , laparoscopic microwave ablation in respect of intraoperative injury , postoperative recovery and costs is superior to other methods , and the treatment effect is certain , it 's feasible and worthy of promotion .

###25099941
OBJECTIVE	By use of a parallel and partly crossover randomised , controlled trial design we sought to elucidate the underlying mechanisms behind the advantageous effects of interval walking training ( IWT ) compared with continuous walking training ( CWT ) on glycaemic control in individuals with type 2 diabetes .
OBJECTIVE	We hypothesised that IWT , more than CWT , would improve insulin sensitivity including skeletal muscle insulin signalling , insulin secretion and disposition index ( DI ) .
METHODS	By simple randomisation ( sequentially numbered , opaque sealed envelopes ) , eligible individuals ( diagnosed with type 2 diabetes , no exogenous insulin treatment ) were allocated to three groups : a control group ( CON , n = 8 ) , an IWT group ( n = 12 ) and an energy expenditure-matched CWT group ( n = 12 ) .
METHODS	Training groups were prescribed free-living training , five sessions per week ( 60 min/session ) .
METHODS	A three-stage hyperglycaemic clamp , including glucose isotope tracers and skeletal muscle biopsies , was performed before and after a 4 month intervention in a hospitalised setting .
METHODS	No blinding was performed .
RESULTS	The improved glycaemic control , which was only seen in the IWT group , was consistent with IWT-induced increases in insulin sensitivity index ( 49.8 14.6 % ; p < 0.001 ) , peripheral glucose disposal ( 14.5 4.9 % ; p < 0.05 ) and DI ( 66.2 21.8 % ; p < 0.001 ) , with no changes in the CWT or CON group .
RESULTS	Moreover , only IWT improved insulin signalling in skeletal muscle via increased insulin-stimulated phosphorylation of AS160 ( 29.0 10.8 % ; p < 0.05 ) .
RESULTS	No changes were seen in insulin secretion during hyperglycaemia alone , hyperglycaemia + glucagon-like peptide 1 infusion or arginine injection .
CONCLUSIONS	IWT maintains insulin secretion and improves insulin sensitivity and DI , in contrast to energy expenditure-matched CWT .
CONCLUSIONS	These results suggest that training with alternating intensity , and not just training volume and mean intensity , is a key determinant of changes in whole body glucose disposal in individuals with type 2 diabetes .
BACKGROUND	ClinicalTrials ( NCT01234155 ) .

###24418366
OBJECTIVE	Although bereavement and depression are both common in older primary care patients , the effect of bereavement on depression intervention outcomes is unknown .
OBJECTIVE	We examined whether standard interventions for depression in primary care were as effective for bereaved as for non-bereaved depressed patients .
METHODS	Randomized controlled trial .
METHODS	Twenty community-based primary care practices in New York City , greater Philadelphia , and Pittsburgh .
METHODS	Randomization to either intervention or usual care occurred by practice .
METHODS	Patients aged 60 years or older who met criteria for major depression or clinically significant minor depression ( N = 599 ) .
METHODS	Patients who did not complete the bereavement measure or who were missing 4-month data were excluded ( final N = 417 ) .
METHODS	Study-trained depression care managers offered guideline-concordant recommendations to primary care physicians at intervention sites and assisted patients with treatment adherence .
METHODS	Patients who did not wish to take antidepressants could receive interpersonal psychotherapy .
METHODS	Bereavement was captured using the Louisville Older Persons Events Schedule .
METHODS	Depression severity was assessed using the 24-item Hamilton Depression Rating Scale ( HDRS ) .
METHODS	Outcomes at 4 months were remission ( HDRS7 ) and response ( HDRS reduction50 % from baseline ) .
RESULTS	Logistic regressions indicated that , for non-bereaved participants , response and remission were higher in intervention than usual care .
RESULTS	However , recently bereaved older adults were less likely to achieve response or remission at 4 months if treated in the intervention condition .
CONCLUSIONS	Standard depression care management appears to be ineffective among recently bereaved older primary care patients .
CONCLUSIONS	Greater attention should be paid in primary care to emotional distress in the context of bereavement .

###24524674
BACKGROUND	Maternal overweight , obesity and consequently the incidence of gestational diabetes are increasing rapidly worldwide .
BACKGROUND	The objective of the study was to assess the efficacy and cost-effectiveness of a combined diet and physical activity intervention implemented before , during and after pregnancy in a primary health care setting for preventing gestational diabetes , later type 2 diabetes and other metabolic consequences .
METHODS	RADIEL is a randomized controlled multi-center intervention trial in women at high risk for diabetes ( a previous history of gestational diabetes or prepregnancy BMI 30 kg/m2 ) .
METHODS	Participants planning pregnancy or in the first half of pregnancy were parallel-group randomized into an intervention arm which received lifestyle counseling and a control arm which received usual care given at their local antenatal clinics .
METHODS	All participants visited a study nurse every three months before and during pregnancy , and at 6 weeks , 6 and 12 months postpartum .
METHODS	Measurements and laboratory tests were performed on all participants with special focus on dietary and exercise habits and metabolic markers.Of the 728 women [ mean age 32.5 years ( SD 4.7 ) ; median parity 1 ( range 0-9 ) ] considered to be eligible for the study 235 were non-pregnant and 493 pregnant [ mean gestational age 13 ( range 6 to 18 ) weeks ] at the time of enrollment .
METHODS	The proportion of nulliparous women was 29.8 % ( n = 217 ) .
METHODS	Out of all participants , 79.6 % of the non-pregnant and 40.4 % of the pregnant women had previous gestational diabetes and 20.4 % of the non-pregnant and 59.6 % of the pregnant women were recruited because of a prepregnancy BMI 30 kg/m2 .
METHODS	Mean BMI at first visit was 30.1 kg/m2 ( SD 6.2 ) in the non-pregnant and 32.7 kg/m2 ( SD 5.6 ) in the pregnant group .
CONCLUSIONS	To our knowledge , this is the first randomized lifestyle intervention trial , which includes , besides the pregnancy period , both the prepregnancy and the postpartum period .
CONCLUSIONS	This study design also provides an opportunity to focus upon the health of the next generation .
CONCLUSIONS	The study is expected to produce novel information on the optimal timing and setting of interventions and for allocating resources to prevent obesity and diabetes in women of reproductive age .

###24415784
BACKGROUND	Human immunodeficiency virus ( HIV ) - infected individuals are at increased risk of cardiovascular disease ( CVD ) due in part to inflammation .
BACKGROUND	Statins decrease inflammation in the general population , but their effect during HIV infection is largely unknown .
METHODS	This is an ongoing randomized , double-blinded , placebo-controlled trial to evaluate the effect of statin therapy on inflammatory markers during HIV infection .
METHODS	Subjects received rosuvastatin 10 mg daily or placebo for 24 weeks .
METHODS	Subjects were receiving stable ( > 12 weeks ) antiretroviral therapy and had a low-density lipoprotein ( LDL ) cholesterol level of 130 mg/dL and evidence of heightened immune activation or inflammation .
METHODS	This was a prespecified interim analysis .
RESULTS	A total of 147 subjects were enrolled ( 78 % were male , 70 % were black , and the median age was 47 years ) .
RESULTS	By 24 weeks , LDL cholesterol levels had decreased in the statin group , compared with an increase in the placebo group ( -28 % vs +3.8 % ; P < .01 ) .
RESULTS	A 10 % reduction in the lipoprotein-associated phospholipase A2 ( Lp-PLA2 ) level was seen in the statin group , compared with a 2 % reduction in the placebo group ( P < .01 ) .
RESULTS	In multivariable regression , receipt of statin treatment and having a nadir CD4 ( + ) T-cell count of 100 cell/L were the only statistically significant predictors of a decrease in Lp-PLA2 level .
RESULTS	Markers of systemic inflammation did not change significantly between groups .
CONCLUSIONS	Twenty-four weeks of rosuvastatin therapy significantly decreased the level of Lp-PLA2 , a vascular-specific , inflammatory enzyme that predicts cardiovascular events in the general population .
CONCLUSIONS	Statins may hold promise as a means of attenuating CVD risk in HIV-infected individuals by decreasing Lp-PLA2 levels .

###24603321
BACKGROUND	A non-blinded , cluster randomised controlled trial to test whether footwear reduces prevalence and intensity of hookworm infection in school-aged children on Pemba Island , Zanzibar .
METHODS	Six schools were randomised to receive shoes and standard care ( deworming with albendazole and health education ) and six control schools to receive standard care only .
METHODS	Children provided a stool sample to assess prevalence and intensity of infection with soil transmitted helminthiases ( Ascaris lumbricoides , Trichuris trichiura and hookworm ) .
METHODS	Shoes were then distributed to pupils in the intervention schools ; deworming took place as part of the government 's mass drug administration programme and a further round of stool samples were collected six months later .
RESULTS	Nine hundred and fifteen children were traced at follow-up ( 1056 at baseline ) .
RESULTS	As many children wore shoes in the control arm as the intervention arm .
RESULTS	There was no difference in hookworm prevalence ( 23.4 % for intervention schools , 21.3 % for control schools , p = 0.48 ) , and no difference in mean hookworm infection in eggs/gram of stool ( 18 , 1-36 in intervention schools , 18 , 7-29 in control schools , p = 0.23 ) .
RESULTS	Shoe-wearing increased across all schools , from 47.4 to 82.4 % .
RESULTS	If a child wore shoes at the end of the study , the relative risk of hookworm infection was 0.7 ( CI 0.53-0 .91 ) .
CONCLUSIONS	Due to contamination , the trial could not conclude that shoes were protective against hookworm infection but the intervention led to behavioural change , and observational data suggest that shoes are protective against hookworm .
CONCLUSIONS	This trial is registered at ClinicalTrials.gov , NCT01869127 .

###24892729
BACKGROUND	The optimal anti-reflux procedure after Heller cardiomyotomy for oesophageal achalasia remains unclear .
BACKGROUND	The most commonly used procedure is the anterior partial fundoplication according to Dor , although during recent years the posterior counterpart ( Toupet ) has become popular .
METHODS	Patients with newly diagnosed achalasia and referred for cardiomyotomy were randomised to receive either an anterior or partial posterior fundoplication following a classical cardiomyotomy .
METHODS	The effect of surgery was assessed during the first postoperative year by Eckardt scores , EORTC QLQ-OES18 scores and HRQL questionnaires .
METHODS	Timed barium oesophagogram ( TBO ) and ambulatory 24-h pH monitoring were performed to determine oesophageal emptying and the degree of reflux control , respectively .
RESULTS	Forty-two patients were randomised into Dor ( n = 20 ) and Toupet ( n = 22 ) groups .
RESULTS	Eckardt scores improved dramatically with both procedures , but the EORTC QLQ-OES18 ( functional scales ) scores revealed significantly better relative improvements in the Toupet group compared to the Dor repair ( P = 0.044 ) .
RESULTS	Corresponding advantages in favour of Toupet were observed postoperatively in the percentage of oesophageal emptying at TBO ( P = 0.011 in height and P = 0.018 in area ) , an effect not observed in the Dor group .
RESULTS	There were no other significant differences recorded between the study groups concerning HRQL evaluations and objective assessment of gastro-oesophageal acid reflux .
CONCLUSIONS	A partial posterior fundoplication after cardiomyotomy seems to achieve more improvement in oesophageal emptying and EORTC QLQ-OES18 functional scale scores than the anterior fundoplication .
CONCLUSIONS	Otherwise no differences between the two anti-reflux repairs were noted .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01933373 .

###26016936
OBJECTIVE	To evaluate a new perfusate solution to be used for ex vivo lung perfusion .
METHODS	Randomized experimental study using lungs from rejected brain-dead donors harvested and submitted to 1 hour of ex vivo lung perfusion ( EVLP ) using mainstream solution or the alternative .
RESULTS	From 16 lungs blocs tested , we found no difference on weight after EVLP : Steen group ( SG ) = 1,097526 g ; Alternative Perfusion Solution ( APS ) = 743248g , p = 0.163 .
RESULTS	Edema formation , assessed by Wet/dry weigh ratio , was statistically higher on the Alternative Perfusion Solution group ( APS = 3.63 1.26 ; SG = 2.06 0.28 ; p = 0.009 ) .
RESULTS	No difference on PaO2 after EVLP ( SG = 49837.53 mmHg ; APS = 52155.43 mmHg , p = 0.348 , nor on histological analyses : pulmonary injury score : SG = 4.381.51 ; APS = 4.501.77 , p = 0.881 ; apoptotic cells count after perfusion : SG = 2.4 2.0 cells/mm2 ; APS = 4.8 6.9 cells/mm2 ; p = 0.361 ) .
CONCLUSIONS	The ex vivo lung perfusion using the alternative perfusion solution showed no functional or histological differences , except for a higher edema formation , from the EVLP using Steen Solution ( r ) on lungs from rejected brain-dead donors .

###25815576
OBJECTIVE	To evaluate whether anti-inflammatory doses of cyclosporine activate Toxoplasma gondii in chronically infected cats or potentiate infection in cats exposed for the first time .
METHODS	30 T gondii-negative cats .
METHODS	Cats were assigned to 1 of 3 groups ( 10 cats/group ) .
METHODS	Group 1 ( control ) cats were administered a placebo for 126 days ; group 2 cats were administered a placebo for 84 days , followed by cyclosporine at 7.5 mg/kg/d , PO , for 42 days ; and group 3 cats were administered cyclosporine at 7.5 mg/kg/d , PO , for 126 days .
METHODS	Cats were orally inoculated with T gondii on day 42 .
METHODS	Results for fecal flotations , PCR assays , and histologic examinations and IgM and IgG titers were analyzed .
METHODS	Cyclosporine concentrations were measured on selected days .
RESULTS	All cats were infected by T gondii and developed signs of self-limiting gastrointestinal tract infection .
RESULTS	Group 3 had the highest incidence and severity of CNS and pulmonary histopathologic findings typical of toxoplasmosis .
RESULTS	One cat in group 3 died of systemic toxoplasmosis ; that cat had a cyclosporine concentration of 1,690 ng/mL .
RESULTS	Group 2 cats infected with T gondii before cyclosporine administration did not have repeated oocyst shedding .
RESULTS	Group 3 cats shed fewer oocysts for a shorter time than did control cats of group 1 .
CONCLUSIONS	Oral administration of cyclosporine in accordance with the protocol for this study did not potentiate the enteroepithelial phase of T gondii infection .
CONCLUSIONS	Cats with high cyclosporine blood concentrations at the time of primary T gondii infection may be at risk of developing systemic toxoplasmosis .

###25381051
OBJECTIVE	Ibrutinib is an oral Bruton 's tyrosine kinase inhibitor , recently approved for the treatment of mantle cell lymphoma ( MCL ) and chronic lymphocytic leukemia ( CLL ) patients with at least one prior therapy .
OBJECTIVE	We developed a population pharmacokinetic ( PK ) model for ibrutinib in patients .
METHODS	Ibrutinib PK data ( 3,477 observations/245 patients ) were available from the following clinical studies : ( 1 ) A phase I dose-escalation study in recurrent B cell malignancies ( dose levels of 1.25-12 .5 mg/kg/day and fixed dose of 560 mg/day ) ; ( 2 ) a phase II study in MCL ( fixed dose level of 560 mg/day ) ; ( 3 ) a phase Ib/II dose-finding study in CLL ( fixed dose levels of 420 and 840 mg/day ) .
METHODS	Different compartmental PK models were explored using nonlinear mixed effects modeling .
RESULTS	A two-compartment PK model with sequential zero-first-order absorption and first-order elimination was able to characterize the PK of ibrutinib .
RESULTS	The compound was rapidly absorbed , had a high oral plasma clearance ( approximately 1,000 L/h ) and a high apparent volume of distribution at steady state ( approximately 10,000 L ) .
RESULTS	PK parameters were not dependent on dose , study , or clinical indication .
RESULTS	The fasting state was characterized by a 67 % relative bioavailability compared with the meal conditions used in the trials and administration after a high-fat meal .
RESULTS	Body weight and coadministration of antacids marginally increased volume of distribution and duration of absorption , respectively .
CONCLUSIONS	The proposed population PK model was able to describe the plasma concentration-time profiles of ibrutinib across various trials .
CONCLUSIONS	The linear model indicated that the compound 's PK was dose independent and time independent .

###25906563
OBJECTIVE	To observe the efficacy differences between acupoint catgut embedding at cervical Jiaji ( EX-B 2 ) points combined with electroacupuncture ( EA ) at acupoints near ear and simple EA for the treatment of nervous tinnitus .
METHODS	Sixty-three patients were randomly divided into an observation group ( 31 cases ) and a control group ( 32 cases ) .
METHODS	The observation group was treated with acupoint catgut embedding at C4-C7 Jiaji ( EXB 2 ) points on the affected side combined with EA at acupoints near ears , including Ermen ( TE 21 ) .
METHODS	Tinggong ( SI 19 ) , Tinghui ( GB 2 ) , etc. ; the control group was treated with EA at regular acupoints near ears alone .
METHODS	The EA treatment was given five times per week , and the acupoint catgut embedding was given once every two weeks .
METHODS	All the treatment was given for 6 weeks .
METHODS	The Tinnitus severity score ( TSS ) was applied to assess the severity of tinnitus before the treatment , 2 weeks , 4 weeks and 6 weeks into treatment and one month after treat ment .
METHODS	Also the efficacy of two groups was compared .
RESULTS	After the treatment , the severity of tinnitus was both improved in two groups at each time point ( all P < 0.05 ) .
RESULTS	which was more significant in the observation group ( P < 0.05 , P < 0.01 ) .
RESULTS	The cured and markedly effective rate was 77.4 % ( 24/31 ) in the observation group , which was superior to 50.0 % ( 16/32 ) in the control group ( P < 0.05 ) .
CONCLUSIONS	The short-term and long-term efficacy of acupoint catgut embedding at cervical Jiaji ( EX-B 2 ) points combined with electroacupuncture are both superior to those of simple electroacupuncture for treatment of nervous tinnitus .

###25022107
OBJECTIVE	To observe the clinical efficacy difference on vegetative state in children between acupoint injection combined with plum-blossom needle and western medication based on basic treatment .
METHODS	Forty-eight children of vegetative state were randomized into an observation group and a control group , 24 cases in each one .
METHODS	On the basis of the treatment of transcranial magnetic stimulation apparatus , balancing treatment apparatus and massage , the acupoint injection and tapping method with plum-blossom needle were adopted in the observation group , in which Xingnaojing injection , mouse nerve growth factor ( mNGF ) injection , monosialotetrahexosylganglioside sodium injection ( MSI ) , compound Danshen injection were divided in 6 pairs and were injected respectively in Baihui ( GV 20 ) , Yongquan ( KI 1 ) , Fengfu ( GV 16 ) , Yamen ( GV 15 ) and the others , 0.5 mL in each acupoint , once a day for continuous 10 days .
METHODS	Additionally , the tapping method with plum-blossom needle was used on the Governor Vessel and Jiaji ( EX-B 2 ) on the back .
METHODS	In the control group , the intravenous infusion was adopted with citicoline sodium injection , mannitol injection and dexamethasone injection .
METHODS	The treatment was given once a day , 20 days of treatment made one session and totally 3 sessions were required in the two groups .
METHODS	The clinical efficacy , the vegetative state score and the mean curing time were observed after 20 days , 40 days and 60 days of treatment between the two groups .
RESULTS	The effective rates were 58.3 % ( 14/24 ) , 70.8 % ( 17/24 ) and 79.2 % ( 19/24 ) in 20 days , 40 days and 60 days of treatment in the observation group and 20.8 % ( 5/24 ) , 45.8 % ( 11/24 ) and 58.3 % ( 14/24 ) in the control group respectively .
RESULTS	The efficacy in the observation group was superior to those in the control group ( P < 0.01 , P < 0.05 ) .
RESULTS	The vegetative state score was improved apparently after 20 days , 40 days and 60 days of treatment as compared with those before treatment separately ( all P < 0.05 ) .
RESULTS	It was improved obviously at the each time point after treatment in the observation group as compared with that in the control group ( 3.34 + / - 2.41 vs 2.64 + / - 11.56 , 6.20 + / - 1.46 vs 4.34 + / - 1.64 , 11.26 + / - 2.63 vs 8.75 + / - 2.18 , all P < 0.05 ) .
RESULTS	The mean curing time was ( 45.67 + / - 16.24 ) days in the observation group , which was shorter apparently than that of ( 55.34 + / - 4.57 ) days in the control group ( P < 0.05 ) .
CONCLUSIONS	Based on basic treatment acupoint injection combined with tapping method of plum-blossom needle achieve the reliable efficacy on vegetative state in children .

###24583571
OBJECTIVE	Three-percent hypertonic saline ( HTS ) is a hyperosmotic therapy used in pediatric traumatic brain injury to treat increased intracranial pressure and cerebral edema .
OBJECTIVE	It also promotes plasma volume expansion and cerebral perfusion pressure , immunomodulation , and anti-inflammatory response .
OBJECTIVE	We hypothesized that HTS will improve concussive symptoms of mild traumatic brain injury .
METHODS	The study was a prospective , double-blind , randomized controlled trial .
METHODS	Children , 4 to 7 years of age with a Glasgow Coma Scale score greater than 13 , were enrolled from a pediatric emergency department following closed-head injury upon meeting Acute Concussion Evaluation criteria with head pain .
METHODS	Patients were randomized to receive 10 mL/kg of HTS or normal saline ( NS ) over 1 hour .
METHODS	Self-reported pain values were obtained using the Wong-Baker FACES Pain Rating Scale initially , immediately following fluids , and at 2 to 3 days of discharge .
METHODS	The primary outcome measure was change in self-reported pain following fluid administration .
METHODS	Secondary outcome measures were a change in pain and postconcussive symptoms within 2 to 3 days of fluid administration .
METHODS	We used an intention-to-treat analysis .
RESULTS	Forty-four patients , ranging from 7 to 16 years of age with comparable characteristics , were enrolled in the study ; 23 patients ( 52 % ) received HTS , and 21 ( 48 % ) received NS .
RESULTS	There was a significant difference ( P < 0.001 ) identified in the self-reported improvement of pain following fluid administration between the HTS group ( mean improvement = 3.5 ) and the NS group ( mean improvement = 1.1 ) .
RESULTS	There was a significant difference ( P = 0.01 ) identified in the self-reported improvement of pain at 2 to 3 days after treatment between the HTS group ( mean improvement = 4.6 ) and the NS group ( mean improvement = 3.0 ) .
RESULTS	We were unable to determine a difference in other postconcussive symptoms following discharge .
CONCLUSIONS	Three-percent HTS is more effective than NS in acutely reducing concussion pain in children .

###24666667
BACKGROUND	There is good evidence of the positive effects of person-centered care ( PCC ) on agitation in dementia .
BACKGROUND	We hypothesized that a person-centered environment ( PCE ) would achieve similar outcomes by focusing on positive environmental stimuli , and that there would be enhanced outcomes by combining PCC and PCE .
METHODS	38 Australian residential aged care homes with scope for improvement in both PCC and PCE were stratified , then randomized to one of four intervention groups : ( 1 ) PCC ; ( 2 ) PCE ; ( 3 ) PCC + PCE ; ( 4 ) no intervention .
METHODS	People with dementia , over 60 years of age and consented were eligible .
METHODS	Co-outcomes assessed pre and four months post-intervention and at 8 months follow-up were resident agitation , emotional responses in care , quality of life and depression , and care interaction quality .
RESULTS	From 38 homes randomized , 601 people with dementia were recruited .
RESULTS	At follow-up the mean change for quality of life and agitation was significantly different for PCE ( p = 0.02 , p = 0.05 , respectively ) and PCC ( p = 0.0003 , p = 0.002 respectively ) , compared with the non-intervention group ( p = 0.48 , p = 0.93 respectively ) .
RESULTS	Quality of life improved non-significantly for PCC+PCE ( p = 0.08 ) , but not for agitation ( p = 0.37 ) .
RESULTS	Improvements in care interaction quality ( p = 0.006 ) and in emotional responses to care ( p = 0.01 ) in PCC+PCE were not observed in the other groups .
RESULTS	Depression scores did not change in any of the groups .
RESULTS	Intervention compliance for PCC was 59 % , for PCE 54 % and for PCC+PCE 66 % .
CONCLUSIONS	The hypothesis that PCC+PCE would improve quality of life and agitation even further was not supported , even though there were improvements in the quality of care interactions and resident emotional responses to care for some of this group .
CONCLUSIONS	The Australian New Zealand Clinical Trials Registry Number is ACTRN 12608000095369 .

###25955980
BACKGROUND	Neuropathic pain is a condition resulting from injury to the peripheral and/or central nervous system .
BACKGROUND	Despite extensive research over the last several decades , neuropathic pain remains difficult to manage .
METHODS	The authors conducted a randomized , placebo-controlled , double-blinded , and crossover clinical trial to examine the effect of 1.5 % topical diclofenac ( TD ) on neuropathic pain .
METHODS	The authors hypothesized that 1.5 % TD would reduce the visual pain score and improve both quantitative sensory testing and functional status in subjects with neuropathic pain .
METHODS	The authors recruited subjects with postherpetic neuralgia and complex regional pain syndrome .
METHODS	The primary outcome was subject 's visual pain score .
RESULTS	Twenty-eight subjects completed the study ( 12 male and 16 female ) with the mean age of 48.8 yr .
RESULTS	After 2 weeks of topical application , subjects in 1.5 % TD group showed lower overall visual pain score compared with placebo group ( 4.9 [ 1.9 ] vs. 5.6 [ 2.1 ] , difference : 0.8 ; 95 % CI , 0.1 to 1.3 ; P = 0.04 ) as well as decreased burning pain ( 2.9 [ 2.6 ] vs. 4.3 [ 2.8 ] , difference , 1.4 ; 95 % CI , 0.2 to 2.6 ; P = 0.01 ) .
RESULTS	There were no statistical differences in constant pain , shooting pain , or hypersensitivity over the painful area between the groups .
RESULTS	This self-reported improvement of pain was corroborated by the decreased pain summation detected by quantitative sensory testing .
RESULTS	There were no statistically significant changes in functional status in these subjects .
RESULTS	There were no complications in both groups .
CONCLUSIONS	The findings indicate that 1.5 % TD may serve as an effective treatment option for patients with neuropathic pain from postherpetic neuralgia and complex regional pain syndrome .

###25793947
OBJECTIVE	Powered or manual toothbrushes are daily-used instrument in the Western area for the control and removal of bacterial biofilm .
OBJECTIVE	Among powered-toothbrushes , sonic technology has shown to produce fluid turbulent activity that might assist in plaque removal ; however , limited knowledge is available in-vivo .
OBJECTIVE	The objectives of this study were to compare the plaque removal efficacy of two different toothbrushes in a population not familiar with sonic technology , and to collect and analyse data regarding oral hygiene habits .
OBJECTIVE	The null-hypothesis was that a sonic toothbrush is able to remove a superior amount of plaque compared to the manual type .
METHODS	Forty young adult patients were enrolled in the study .
METHODS	A single-cohort crossover clinical trial was designed .
METHODS	For each patient , three appointments were scheduled : the first ( T0 ) was used for oral care education and explanations of toothbrushes techniques , for a preliminary professional hygiene session , and for delivery of a questionnaire ; at one week ( T1 ) , plaque evaluation was performed ( Turesky modification of the Quigley and Hein index ) at baseline and after asking patients to brush with the randomly selected manual or sonic device .
METHODS	At the last appointment ( week 3 , T2 ) , the same plaque evaluations of T1 were repeated asking patients to brush with the other toothbrush .
METHODS	Entire mouth indexes were calculated and mean reductions in whole mouth plaque scores were obtained ( pre-brushing minus post-brushing values ) for the two tested toothbrushes .
METHODS	Multiple ANOVA tests ( p = 0.05 ) were used 1 ) to compare plaque levels between male and female subjects at baseline and post-brushing , regardless the type of toothbrush , and 2 ) to differentiate between mean reductions in whole mouth plaque scores according to the type of toothbrush ( manual versus sonic ) .
METHODS	The study population was subjected to descriptive statistical analysis ; potential relationships between socio-demographic variables and obtained plaque scores were evaluated ( Mann-Whitney and Kruskal-Wallis tests ) .
RESULTS	Full-mouth plaque levels were reduced at post-brushing sessions , regardless the device , by approximately 62 % ( p < 0.0001 ) .
RESULTS	Mean plaque index reductions for manual and sonic toothbrush were of 1.05 0.22 and 1.19 0.37 , respectively .
RESULTS	A statistically significant difference was found between the two devices ( p = 0.0342 ) .
RESULTS	The powered sonic toothbrush removed about 10 % more plaque than the manual type .
RESULTS	From the collected questionnaire financial data , willingness to pay ( WTP ) values expressing economic efforts of patients for the purchase of toothbrushes were of Euros 4.83 3.86 and of Euros 54.75 36 , for the manual and sonic devices , respectively .
CONCLUSIONS	Within the limitations of the study , in subjects without any previous experience of a similar technology , the single use of the sonic toothbrush showed a significantly greater plaque reduction compared to the manual traditional toothbrush ( null-hypothesis accepted ) .

###25012612
BACKGROUND	The effect of vitamin D replacement on hemoglobin ( Hb ) concentration in subjects with concurrent deficiencies of vitamin D and iron is not known .
METHODS	We report on an investigator-initiated , randomized , single-blinded , placebo-controlled , 12-week interventional trial .
METHODS	Thirty subjects with iron-deficiency anemia ( serum ferritin < 15 g/l ) were randomized to an intervention arm ( cholecalciferol , i.e. vitamin D3 , 0.6 million units i.m. once ) or placebo .
METHODS	In all subjects , iron deficiency was corrected with parental iron .
METHODS	Other causes of anemia were excluded with appropriate investigation .
METHODS	The primary end point was a rise in Hb concentration .
RESULTS	Baseline parameters of age , BMI , hemogram values and levels of serum ferritin , 25-hydroxyvitamin D [ 25 ( OH ) D ] and parathyroid hormone ( PTH ) were similar in the 2 arms .
RESULTS	Twelve weeks after vitamin D replacement , there was a significant increase in 25 ( OH ) D levels ( 57.7 20.5 vs. 14.1 6.2 ng/ml , p < 0.0001 ) and a decrease in PTH levels ( 32.4 16.4 vs. 52.9 18.4 pg/ml , p = 0.003 ) in subjects in the intervention arm when compared to the placebo arm .
RESULTS	However , the increments in serum ferritin and Hb concentration in the intervention and placebo arm did not differ .
CONCLUSIONS	Vitamin D replacement in subjects with iron-deficiency anemia after iron correction does not improve Hb concentration further .

###24224515
OBJECTIVE	Premedication with intranasal dexmedetomidine ( DEX ) has shown to be an effective sedative in pediatric patients .
OBJECTIVE	This prospective , randomized , and controlled investigation was designed to evaluate whether the difference in intranasal DEX dosing would produce different beneficial effects on the attenuation of cardiovascular and arousal responses during anesthesia induction and intubation .
METHODS	Forty children , aged from 3 to 6years , of American Society of Anesthesiologists physical status I or II and scheduled for elective adenotonsillectomy randomly received intranasal DEX 1gkg ( -1 ) ( group D1 ) or 2gkg ( -1 ) ( group D2 ) 30min before anesthesia induction .
METHODS	Anesthesia was induced with sevoflurane in oxygen flow .
METHODS	Mean arterial pressure ( MAP ) and heart rate ( HR ) as measurements of cardiovascular response and bispectral index ( BIS ) as an index of arousal response were recorded every 5min after intranasal DEX administration and measured every 1min for 5min after intubation .
METHODS	Sedation status , behavior scores , and mask induction scores were also assessed .
RESULTS	Mean arterial pressure did not show statistical differences during the anesthesia induction , but did demonstrate significantly milder responses to laryngoscopy and intubation in group D2 compared with group D1 .
RESULTS	Change in HR was consistent with MAP during laryngoscopy and intubation .
RESULTS	Patients who received 2gkg ( -1 ) DEX presented with deeper sedation and less anxiety by the assessments of the alertness scale , behavior score , and BIS scores .
RESULTS	Group D2 dosing achieved more favorable scores in children undergoing mask induction .
CONCLUSIONS	Intranasal DEX 2gkg ( -1 ) administered 30min before anesthesia induction provides considerable effect to attenuate the increase in MAP caused by intubation response .
CONCLUSIONS	Changes in HR and BIS also demonstrate that this kind of premedication provides effective attenuation of intubation response .
CONCLUSIONS	And preoperative intranasal DEX 2gkg ( -1 ) produces optimal-sedation , more favorable anesthesia induction course in pediatric patients .
CONCLUSIONS	Premedication of intranasal DEX is a considerable way to blunt cardiovascular and arousal responses to endotracheal intubation .

###24490949
OBJECTIVE	To assess the effect of ginger consumption on glycemic status , lipid profile and some inflammatory markers in patients with type 2 diabetes mellitus .
METHODS	In a double-blinded , placebo-controlled clinical trial , 70 type 2 diabetic patients were enrolled .
METHODS	They allocated randomly into ginger group and control group .
METHODS	They consumed 1600mg ginger versus 1600mg wheat flour placebo daily for 12 weeks .
METHODS	Serum sugar , lipids , CRP , PGE2 and TNF were measured before and after intervention .
RESULTS	Ginger reduced fasting plasma glucose , HbA1C , insulin , HOMA , triglyceride , total cholesterol , CRP and PGE significantly compared with placebo group ( p < 0.05 ) .
RESULTS	There were no significant differences in HDL , LDL and TNF between two groups ( p > 0.05 ) .
CONCLUSIONS	Ginger improved insulin sensitivity and some fractions of lipid profile , and reduced CRP and PGE in type 2 diabetic patients .
CONCLUSIONS	Therefore ginger can be considered as an effective treatment for prevention of diabetes complications .

###25377395
OBJECTIVE	Low-dose ketamine has been used perioperatively for pain control and may be a useful adjunct to intravenous ( IV ) opioids in the control of acute pain in the emergency department ( ED ) .
OBJECTIVE	The aim of this study was to determine the effectiveness of low-dose ketamine as an adjunct to morphine versus standard care with morphine alone for the treatment of acute moderate to severe pain among ED patients .
METHODS	A double-blind , randomized , placebo-controlled trial with three study groups was conducted at a large , urban academic ED over a 10-month period .
METHODS	Eligible patients were 18 to 65 years old with acute moderate to severe pain ( score of at least 5 out of 10 on the numerical pain rating scale [ NRS ] and pain duration < 7 days ) who were deemed by their treating physician to require IV opioids .
METHODS	The three study groups were : 1 ) morphine and normal saline placebo ( standard care group ) , 2 ) morphine and 0.15 mg/kg ketamine ( group 1 ) , or 3 ) morphine and 0.3 mg/kg ketamine ( group 2 ) .
METHODS	Participants were assessed at 30 , 60 , and 120 minutes after study medication administration and received rescue analgesia as needed to target a 50 % reduction in pain .
METHODS	The primary outcome measure of pain relief , or pain intensity reduction , was derived using the NRS and calculated as the summed pain-intensity ( SPID ) difference over 2 hours .
METHODS	The amount and timing of rescue opioid analgesia was evaluated as a secondary outcome .
METHODS	The occurrence of adverse events was also measured .
RESULTS	Sixty patients were enrolled ( n = 20 in each group ) .
RESULTS	There were no differences between study groups with respect to age , sex , race/ethnicity , preenrollment analgesia , or baseline NRS .
RESULTS	Over the 2-hour poststudy medication administration period , the SPIDs were higher ( greater pain relief ) for the ketamine study groups than the control group ( standard care 4.0 , interquartile range [ IQR ] = 1.8 to 6.5 ; group 1 7.0 , IQR = 4.3 to 10.8 ; and group 2 7.8 , IQR = 4.8 to 12.8 ; p < 0.02 ) .
RESULTS	The SPIDs for the ketamine groups were similar ( p < 0.46 ) .
RESULTS	When compared to standard care , group 2 sustained the reduction in pain intensity up to 2 hours , whereas group 1 was similar to standard care by 2 hours .
RESULTS	Similar numbers of patients received rescue analgesia : standard care group , seven of 20 , 35 % ; group 1 , four of 20 , 20 % ; and group 2 , four of 20 , 20 % ( p = 0.48 ) .
RESULTS	Among those receiving rescue analgesia , those in the standard care group received analgesia sooner than either low-dose ketamine group , on average .
RESULTS	More participants in the low-dose ketamine groups reported dysphoria and dizziness .
CONCLUSIONS	Low-dose ketamine is a viable analgesic adjunct to morphine for the treatment of moderate to severe acute pain .
CONCLUSIONS	Dosing of 0.3 mg/kg is possibly more effective than 0.15 mg/kg , but may be associated with minor adverse events .
CONCLUSIONS	Future studies should evaluate additional outcomes , optimum dosing , and use in specific populations .

###24895301
BACKGROUND	Melasma is distressing for patients and challenging for physicians to treat .
BACKGROUND	Clinical data from controlled comparative studies is lacking to support the efficacy , longevity , and safety of laser treatments for melasma .
OBJECTIVE	Compare the efficacy and safety of low fluence Q-switched neodymium-doped yttrium aluminum garnet ( 1,064 nm ) laser ( Nd : YAG ) versus low-fluence Q-switched alexandrite laser ( 755nm ) ( QSAL ) for the treatment of facial melasma .
METHODS	Twenty male and female subjects with moderate to severe mixed-type melasma on both sides of the face were randomized to six , weekly treatments with the low-fluence Q-switched Nd : YAG laser on one side and the low-fluence QSAL to the other side .
METHODS	Two independent investigators conducted Modified Melasma Area and Severity Index ( MMASI ) evaluations and subjects completed self-assessment questionnaires at baseline , after three treatments and each follow-up visit 2 , 12 , and 24 weeks after the last treatment .
METHODS	Standardized digital photographs were taken at baseline and at each subsequent follow-up visit .
RESULTS	One male and fifteen females , mean age of 43.4 ( range 32-64 ) years , completed the 29-week study .
RESULTS	Both laser treated sides showed a significant improvement in MMASI evaluations after two treatments ( 22 % improvement on the QS-Nd : YAG , 17 % QSAL ) and each follow-up visit 2 ( 36 % QS-Nd : YAG ; 44 % QSAL ) , 12 ( 27 % QS-Nd : YAG ; and 24 % QSAL ) , and 24 weeks ( 27 % QS-Nd : YAG ; and 19 % QSAL ) after the last treatment , but no significant difference was seen between study groups at any visit .
RESULTS	There was also no significant difference in subject evaluation of improvement between both treatment sides at any visit .
RESULTS	Both laser treated sides were tolerated well , and no serious adverse events were noted .
RESULTS	Only one subject was taken out of the study due to development of post-inflammatory hyperpigmentation bilaterally .
CONCLUSIONS	Both low-fluence Q-switched Nd : YAG and low-fluence QSAL were equally effective at improving moderate to severe mixed-type facial melasma .
CONCLUSIONS	This was a single-center trial and patients were not able to use complimentary lightening agents during the study .

###25502833
OBJECTIVE	This is a prospective , randomized , multicenter , investigator-initiated trial to evaluate the 12-month effectiveness of isovolemic hemodilution ( IH ) with prompt versus deferred intravitreal injections ( IVI ) of ranibizumab 0.5 mg for the treatment of macular edema secondary to early central retinal vein occlusion ( CRVO ) .
METHODS	Eyes with macular edema due to CRVO having occurred not more than 8 weeks previously received either monthly ranibizumab IVI in combination with IH ( group I , n = 28 ) or IH alone ( group II , n = 30 ) .
METHODS	From month 2 to 12 , the patients in both groups could be treated with monthly intravitreal ranibizumab .
METHODS	The main outcome variables were gain of visual acuity and the course of central retinal thickness as measured with optical coherence tomography .
RESULTS	At 12 months , eyes in group I on average gained +28.1 ( 19.3 ) letters compared to +25.2 ( 20.9 ) letters in group II ( p = 0.326 ) .
RESULTS	This result was achieved with significantly fewer injections in group II .
RESULTS	Additionally , 30 % of the eyes in group II did not need ranibizumab IVI during the 12 months of the trial .
CONCLUSIONS	Ranibizumab IVI in addition to IH proved to be highly effective in increasing visual acuity and reducing macular edema secondary to CRVO .
CONCLUSIONS	Initial IH in early CRVO may be a first treatment option in patients anxious about IVI .

###25443754
OBJECTIVE	Friction foot blisters are a common injury occurring in up to 39 % of marathoners , the most common injury in adventure racing , and represent more than 70 % of medical visits in multi-stage ultramarathons .
OBJECTIVE	The goal of the study was to determine whether paper tape could prevent foot blisters in ultramarathon runners .
METHODS	This prospective randomized trial was undertaken during RacingThePlanet 155-mile ( 250-km ) , 7-day self-supported ultramarathons in China , Australia , Egypt , Chile , and Nepal in 2010 and 2011 .
METHODS	Paper tape was applied prerace to one randomly selected foot , with the untreated foot acting as the own control .
METHODS	The study end point was development of a hot spot or blister on any location of either foot .
RESULTS	One hundred thirty-six participants were enrolled with 90 ( 66 % ) having completed data for analysis .
RESULTS	There were 36 % women , with a mean age of 40 9.4 years ( range , 25-40 years ) and pack weight of 11 1.8 kg ( range , 8-16 kg ) .
RESULTS	All participants developed blisters , with 89 % occurring by day 2 and 59 % located on the toes .
RESULTS	No protective effect was observed by the intervention ( 47 versus 35 ; 52 % versus 39 % ; P = .22 ) , with fewer blisters occurring around the tape on the experimental foot than under the tape ( 23 vs 31 ; 25.6 % versus 34.4 % ) , yet 84 % of study participants when queried would choose paper tape for blister prevention in the future .
CONCLUSIONS	Although paper tape was not found to be significantly protective against blisters , the intervention was well tolerated with high user satisfaction .

###25056504
OBJECTIVE	The aim of the current study was to compare the effects of intraoperative infusion of 20 % human albumin versus 0.9 % normal saline on early and late graft function in renal transplantation .
METHODS	This prospective , randomized study was conducted on 44 patients with end-stage renal disease undergoing kidney transplantation .
METHODS	Patients were 32 males ( 72.7 % ) and 12 females ( 27.3 % ) with a mean age of 54.35 11.15 years ( range 20-58 years ) .
METHODS	Patients with cardiac disease and liver dysfunction were excluded from the study .
METHODS	Twenty-two of the 44 patients were given intraoperative intravenous infusion of 20 % human albumin with 0.9 % normal saline ( albumin group ) , and the remaining 22 patients received intraoperative intravenous infusion of 0.9 % normal saline alone ( saline group ) , as part of the intraoperative fluid hydration to keep central venous pressure between 10 and 15 mm of Hg .
RESULTS	There was no statistically significant difference in mean intravenous fluid volume infused until the end of surgery between the saline group and the albumin group ( P = 0.8326 ) .
RESULTS	Time of onset of diuresis and total intraoperative urine output were statistically insignificant between the two groups ( P = 0.6255 , P = 0.9231 , respectively ) .
RESULTS	Post-transplant serum creatinine on day 1 , 3 and 5 between the albumin and saline groups were comparable ( P = 0.8998 , P = 0.7257 , P = 0.8092 , respectively ) .
RESULTS	Post-transplant urine output on day 1 , 3 and 5 between the albumin and saline groups were also comparable ( P = 0.653 , P = 0.9075 , P = 0.946 , respectively ) .
RESULTS	Mean postoperative weight gain was higher in the saline group compared with the albumin group , but was not statistically significant ( P = 0.6348 ) .
CONCLUSIONS	This study revealed that the use of 20 % human albumin as an intraoperative volume expander provides no more benefit than the use of 0.9 % normal saline in terms of immediate graft function in living donor renal transplantation .

###25906560
OBJECTIVE	To observe the clinical efficacy differences between regular acupuncture combined with acupuncture at trigone of urinary bladder and simple regular acupuncture for treatment of urination dysfunction induced by spinal cord injury .
METHODS	Sixty patients were randomized into an observation group and a control group , 30 cases in each one .
METHODS	The control group was treated with regular acupuncture at Sanyinjiao ( SP 6 ) , Zusanli ( ST 36 ) , Zhongwan ( CV 12 ) and Tianshu ( ST 25 ) , etc. .
METHODS	Based on the treatment of control group , the observation group was additionally treated with intensive needling at trigone of urinary bladder , once a day , 30 min per treatment .
METHODS	Ten treatments were considered as one course , and there was an interval of two days between courses , 4 courses of treatment were given in two groups .
METHODS	The improvement of urination function in two groups was evaluated , and the efficacy of urination function in two groups was compared .
RESULTS	After treatment , the times of urine leakage , maximum urine output , bladder capacity and residual urine were all improved in two groups ( all P < 0.05 ) .
RESULTS	The improvement of times of urine leakage , bladder capacity and residual urine in the observation group was superior to that in the control group ( all P < 0.05 ) .
RESULTS	The total effective rate was 96.7 % ( 29/30 ) in the observation group , which was superior to 83.3 % ( 25/30 ) in the control group ( P < 0.05 ) .
CONCLUSIONS	The efficacy of regular acupuncture combined with intensive needling at trigone of urinary bladder on urination dysfunction induced by spinal cord injury is significantly superior to that of simple regular acupuncture .

###24660605
OBJECTIVE	To investigate the curative effects of Xuebijing ( XBJ ) injection , a Chinese patent medicine , on severe pulmonary contusion ( PC ) .
METHODS	Sixty-three patients with PC were randomized to conventional therapy plus XBJ injection ( n = 33 ) or conventional therapy alone ( n = 30 ) .
METHODS	Between groups differences in corticosteroid treatment , immune regulation therapy , hemofiltration , infusion volume , transfusion volume and antibiotic period were measured , as were intensive care unit ( ICU ) - free time , ventilation time , 28-day mortality rate and incidence of ventilation-associated pneumonia ( VAP ) .
METHODS	Serum concentrations of procalcitonin ( PCT ) , tumor necrosis factor-alpha ( TNF-alpha ) , interleukin ( IL ) -6 , and IL-10 , white blood cell ( WBC ) counts and percentages of human leukocyte antigen DR / CD14 + ( HLA-DR/CD14 + ) peripheral blood mononuclear cells were compared .
METHODS	Markers of ventilation were determined by blood gas analysis and ventilator parameters .
RESULTS	WBC counts and serum concentrations of PCT , TNF-alpha , IL-6 and IL-10 were reduced significantly more quickly , and CD14 + percentage was increased significantly earlier , in the XBJ group than in the control group ( P < 0.05 each ) .
RESULTS	The level of ventilation and oxygenation index were ameliorated earlier in the XBJ than in the control group ( P < 0.05 ) .
RESULTS	XBJ treatment significantly reduced ICU-free time , ventilation time and incidence of VAP ( P < 0.05 each ) , but had no effect on 28-day mortality rate
CONCLUSIONS	XBJ treatment can shorten ICU-free and ventilation times and reduce the incidence of VAP , improving outcomes in patients with severe PC .
CONCLUSIONS	XBJ may act by regulating inflammation and immunity , alleviating systemic inflammatory response syndrome induced by trauma .

###24646529
OBJECTIVE	This study aimed to investigate the effects of a simulation-based curriculum for ward-based care on ward round ( WR ) performance .
BACKGROUND	Variability in surgical outcomes does not relate to surgical skill alone .
BACKGROUND	Prevention , diagnosis , and treatment of peri - and postoperative morbidity are dependent on provision of high-quality ward-based care .
BACKGROUND	The focal point of this is the surgical WR .
BACKGROUND	Although WR conduct is learned primarily through experience , a simulated environment and validated assessment tools may enable measurement and enhancement of WR quality .
METHODS	Junior surgical residents were randomized either to a half-day educational intervention with lectures , structured feedback , and debriefing , or to standard practice ( control ) .
METHODS	All conducted a standardized , validated , simulated WR of 3 patients .
METHODS	Surgical Ward Care Assessment Tool and W-NOTECHS rating scales were used for technical and nontechnical skills assessment , respectively , and compared between groups .
METHODS	Subjects completed pre - and posttest confidence questionnaires and feedback forms .
RESULTS	Twenty-nine trainees were randomized to intervention ( n = 14 ) or control ( n = 15 ) .
RESULTS	Baseline confidence and demographics were equal between groups .
RESULTS	Intervention group demonstrated better patient assessment : 63.5 8.1 % ( control ) versus 79.8 11.9 % ( P = 0.002 ) , management 56.0 % 19.7 % versus 72.2 10.3 % ( P = 0.014 ) , and nontechnical skills : W-NOTECHS 17.75 2.06 versus 23.33 1.21 ( P < 0.001 ) .
RESULTS	Hundred percent of subjects felt that the curriculum improved their practice .
CONCLUSIONS	Conducting WRs is a crucial skill but not currently subject to formal training .
CONCLUSIONS	Implementation of a comprehensive curriculum for surgical WRs led to significant improvement in quality of patient assessment , management , and nontechnical skills .
CONCLUSIONS	Improved WR performance may lead to earlier identification and amelioration of complications and improve patient outcomes .

###24858916
OBJECTIVE	To explore the enhancing effect of alcohol consumption on attractiveness ratings , in that few studies on the Beer Goggles effect control the stimuli attractiveness level and researchers have seldom considered extending the effect to stimuli other than faces .
METHODS	Male and female participants ( n = 103 ) were randomly assigned to alcohol consumption or placebo groups .
METHODS	Both groups were asked to assess the attractiveness of two types of pictures ( faces and landscapes ) with three levels of attractiveness for each stimulus category ( high , moderate and low ) .
RESULTS	We found significant interactions between beverage type and attractiveness level .
RESULTS	Attractiveness ratings for moderate - and low-attractiveness faces were significantly higher in the alcohol compared with placebo condition , while there was no significant difference for high-attractiveness stimuli between these two conditions .
RESULTS	As for landscapes , only low-attractiveness stimuli were rated significantly higher in the alcohol condition .
CONCLUSIONS	Whether or not alcohol consumption leads to an increase in attractiveness ratings depends on the initial attractiveness of the stimulus materials .
CONCLUSIONS	Alcohol consumption tends to affect ratings for stimuli with relatively low attractiveness .
CONCLUSIONS	Furthermore , this effect is not limited to faces ; it extends to other types of stimuli like landscapes .

###24439440
OBJECTIVE	To describe the minimum inhibitory concentration ( MIC ) of fungal isolates to natamycin and voriconazole , and to compare these MICs to previous ocular susceptibility studies .
METHODS	Experimental laboratory study using isolates from a randomized clinical trial .
METHODS	The Mycotic Ulcer Treatment Trial I was a randomized , double-masked , multicenter trial comparing topical natamycin and voriconazole for fungal keratitis treatment .
METHODS	Susceptibility testing to natamycin and voriconazole were performed according to Clinical and Laboratory Standards Institute methods .
METHODS	The relationship between organism and MIC was assessed .
METHODS	A literature review was performed to compare results to previous ocular susceptibility studies .
RESULTS	Of the 323 patients enrolled in the trial , MICs were available for 221 ( 68 % ) .
RESULTS	Fusarium ( n = 126 ) and Aspergillus species ( n = 52 ) were the most commonly isolated organisms .
RESULTS	MICs to natamycin and voriconazole were significantly different across all genera ( P < .001 ) .
RESULTS	The MIC median ( MIC50 ) and 90th percentile ( MIC90 ) for natamycin were equal to or higher than voriconazole for all organisms except Curvularia species .
RESULTS	Compared to other organisms , Fusarium species isolates had the highest MICs to voriconazole and Aspergillus flavus isolates had the highest MICs to natamycin .
RESULTS	Our results were similar to previous reports except that the voriconazole MIC90 against Aspergillus species was 2-fold higher and the natamycin MIC90 against Aspergillus fumigatus was 4-fold higher in our study .
CONCLUSIONS	In this large susceptibility study , Fusarium isolates were least susceptible to voriconazole and A flavus isolates were least susceptible to natamycin when compared to other filamentous fungi .
CONCLUSIONS	In the future , susceptibility testing may help guide therapy if performed in a timely manner .

###25591516
OBJECTIVE	To determine the optimal duration of energy corrective treatment of ischemic stroke ( II ) with cytoflavin or ascorbic acid .
METHODS	A multicenter randomized clinical trial included 185 patients , aged 40-75 years .
METHODS	Patients were randomized into 3 groups : the control group ( n = 64 ) received ascorbic acid ; cytoflavin group 1 ( n = 72 ) was treated for 10 days and cytoflavin group 2 ( n = 49 ) for 20 days .
METHODS	In all groups , mean NIHSS score was 13 , 42.2 % of patients scored 14 and on admission , 42.2 % of patients had consciousness impairment of different severity .
RESULTS	Cytoflavin treatment was more efficient than ascorbic acid that can be explained by different pharmacologic mechanisms .
RESULTS	Treatment with cytoflavin for 10 days resulted in a significant decrease of ischemia zone volume by 25.2 % , treatment with cytoflavin for 20 days - by 29.0 % , which was associated with better outcomes in neurologic and functional status .
RESULTS	Ascorbic acid demonstrated no effect on morphologic parameters .
RESULTS	Prolonged treatment with cytoflavin in critically ill patients led to significant improvement in clinical and morphologic variables compared to the 10-day course .
RESULTS	In patients with less severe condition comparable results were obtained .
CONCLUSIONS	Our data justify the need for personalized integrated antioxidant and energy correction therapy .

###24942055
OBJECTIVE	To assess the effect of an opioid administered topically onto a standardized skin wound in patients without significant comorbidity .
OBJECTIVE	Findings to date are contradictory , often obtained from multimorbid patients with wounds lacking uniformity .
METHODS	Forty-four patients undergoing surgery for skin grafting were randomly assigned to receive morphine ( 0.25 , 0.75 or 1.25 mg/100cm ( 2 ) wound size ) in hydroxyethylcellulose gel or placebo applied onto the excised split-thickness donor wound at the end of surgery .
METHODS	Pain , supplementary systemic opioids and adverse effects were assessed during the first 24h after application .
METHODS	Healing was examined when the dressings were removed .
RESULTS	Morphine doses ranged from 0.25 to 5.4 mg ( mean 1.93 standard deviation 1.34 mg ) .
RESULTS	No differences in pain scores or use of supplementary analgesics were found between the groups .
RESULTS	Serious adverse effects did not occur ; healing was not impaired .
RESULTS	Large intragroup variability was observed for pain scores , wound sizes and supplementary analgesia .
CONCLUSIONS	Patients treated with topically applied morphine gel onto standardized skin wounds did not report lower pain scores compared with placebo-treated patients .
CONCLUSIONS	Larger groups would be required to arrive at definitive conclusions .
CONCLUSIONS	The split-thickness skin graft model can be used for future research .

###24824118
OBJECTIVE	To prospectively observe the long-term antiviral efficacy and safety of telbivudine ( LDT ) administered as a monotherapy and as a combination therapy with adefovir dipivoxil ( ADV ) in patients diagnosed with chronic hepatitis B ( CHB ) and positivity for hepatitis B e antigen ( HBeAg ) .
METHODS	A total of 140 patients with HBeAg-positive CHB were randomly divided into treatment groups for LDT monotherapy ( n = 75 ; 600 mg orally , once daily ) and LDT+ADV combination therapy ( n = 65 ; LDT 600 mg plus ADV 10 mg orally , once daily ) .
METHODS	The shortest treatment course was 96 weeks and the longest was 240 weeks .
METHODS	At treatment weeks 12 , 24 , 48 ?
METHODS	, 96 , 144 , 192 , and 240 patients were tested for hepatitis B virus ( HBV ) DNA , HBeAg seroconversion and ALT normalization time ; in addition , the incidence and type of adverse drug reactions were recorded .
METHODS	Data were statistically analyzed to determine the significance of differences observed between groups .
RESULTS	The rate of patients experiencing more than or equal to 2 log HBV DNA reduction was higher in the LDT + ADV group ( 92.3 % ( 60/65 ) vs. LDT : 86.7 % ( 65/75 ) , X2 = 1.58 ) .
RESULTS	The HBV DNA negative rates of the LDT and LDT + ADV groups were 62.7 % and 61.5 % ( X2 = 0.01 ) at week 24 , 76.0 % and 81.5 % ( X2 = 0.63 ) at week 48 , 80.0 % and 89.2 % ( X2 = 2.2 ) at week 96 , 78.3 % and 93.3 % ( X2 = 3.24 ) at week 144 , 83.7 % and 91.7 % ( X2 = 0.47 ) at week 192 , and 93.3 % and 88.9 % at week 240 ( comparison between two groups for each point P more than 0.05 ) ; both groups showed higher early and rapid sustained HBV DNA negative rates .
RESULTS	For the HBeAg seroconversion , the rates of the LDT and LDT + ADV groups were 17.3 % and 23.1 % ( X2 = 0.71 ) at week 24 , 29.3 % and 30.8 % ( X2 = 0.03 ) at week 48 , 42.7 % and 40.0 % ( X2 = 0.10 ) at week 96 , 55.0 % and 43.3 % ( X2 = 1.08 ) at week 144 , 55.8 % and 66.7 % ( X2 = 0.45 ) at week 192 , and 63.3 % and 66.7 % at week 240 ; however , pairwise comparison showed no statistically significant differences between the groups ( P more than 0.05 ) .
RESULTS	Similarly , there was no significant difference between the two groups in incidence of resistance at week 48 ( 4.0 % and 1.5 % ) , week 96 ( 5.3 % and 3.1 % ) , week 144 ( 10.0 % and 3.3 % , X2 = 1.23 ) , week 192 ( 11.6 % and 8.3 % ) , and week 240 ( 13.3 % and 11.1 % ) ( all P more than 0.05 ) .
RESULTS	Three patients experienced muscle soreness ( LDT , n = 2 ; LDT + ADV , n = 1 ) and two patients experienced increased creatine phosphokinase ( LDT , n = 1 ; LDT + ADV , n = 1 ) ; all side effects resolved spontaneously or with symptom-appropriate treatment .
CONCLUSIONS	The long-term efficacy of LDT as a monotherapy or as a combination therapy with ADV was similar and the two different treatment approaches were associated with similar rates of resistance .
CONCLUSIONS	The long-term safety was good for both treatment approaches .

###25224239
OBJECTIVE	To assess the efficacy and safety of inhaled nebulized hypertonic saline ( HS ) solution in infants with acute bronchiolitis .
METHODS	Totally 129 patients with acute bronchiolitis ( clinical severity score 4 , aged 2-18 months ) admitted to the Capital Institute of Pediatrics from November 2012 to January 2013 were enrolled .
METHODS	All the subjects were assigned to receive 1.5 ml compound ipratropium bromide solution for inhalation and 1 ml budesonide firstly , twice a day .
METHODS	Then , the subjects were randomized to receive 2 ml doses of nebulized 5 % HS ( Group A ) , 3 % HS ( Group B ) or 0.9 % NS ( Group C ) , twice a day .
METHODS	The treatment lasted for 3 days .
METHODS	Clinical severity scores before treatment and 24 , 48 , 72 h after treatment were documented .
METHODS	Bronchospasm , nausea and emesis were recorded to assess safety .
RESULTS	A total of 124 patients completed this research.Group A included 40 cases , Group B included 42 cases , Group C included 42 cases .
RESULTS	Demographic characteristics , pre-treatment duration and clinical severity score before treatment were similar among the 3 group.Seventy-two hours after treatment , the clinical severity score of Group A , B , and C were 3.5 ( 1.0 ) , 4.0 ( 1.0 ) and 5.0 ( 0 ) .
RESULTS	At 24 , 48 , and 72 h after treatment , the clinical severity score were significantly different among the three groups ( ( 2 ) = 36.000 , 51.200 , 50.800 , P < 0.05 ) .
RESULTS	One patient in Group A got paroxysmal cough everytime as soon as he received 5 % HS ( 6 times ) .
RESULTS	Other 3 patients in Group A got paroxysmal cough once .
RESULTS	The incidence of adverse effect of Group A was 3.75 % ( 9/240 ) ; no adverse event occurred in other group .
RESULTS	The incidence of adverse effect among this three group was significantly different ( ( 2 ) = 19.13 , P < 0.01 ) .
CONCLUSIONS	Inhalation of nebulized 5 % and 3 % hypertonic saline could decrease clinical symptoms of patient with acute bronchiolitis ; 5 % HS was superior to 3 % HS .
CONCLUSIONS	But 2 ml dose of 5 % HS may induce paroxysmal cough .

###25061882
BACKGROUND	This study tested the effectiveness of moxibustion on pain and function in chronic knee osteoarthritis ( KOA ) and evaluated safety .
METHODS	A multi-centre , non-blinded , parallel-group , randomised controlled trial compared moxibustion with usual care ( UC ) in KOA .
METHODS	212 South Korean patients aged 40-70 were recruited from 2011-12 , stratified by mild ( Kellgren/Lawrence scale grades 0/1 ) and moderate-severe KOA ( grades 2/3/4 ) , and randomly allocated to moxibustion or UC for four weeks .
METHODS	Moxibustion involved burning mugwort devices over acupuncture and Ashi points in affected knee ( s ) .
METHODS	UC was allowed .
METHODS	Korean Western Ontario and McMaster Universities Questionnaire ( K-WOMAC ) , Short Form 36 Health Survey ( SF-36v2 ) , Beck Depression Inventory ( BDI ) , physical performance test , pain numeric rating scale ( NRS ) and adverse events were evaluated at 5 and 13 weeks .
METHODS	K-WOMAC global score at 5 weeks was the primary outcome .
RESULTS	102 patients ( 73 mild , 29 moderate-severe ) were allocated to moxibustion , 110 ( 77 mild , 33 moderate-severe ) to UC .
RESULTS	K-WOMAC global score ( moxibustion 25.42 + / - SD 19.26 , UC 33.60 + / -17.91 , p < 0.01 , effect size = 0.0477 ) , NRS ( moxibustion 44.77 + / -22.73 , UC 56.23 + / -17.71 , p < 0.01 , effect size = 0.0073 ) and timed-stand test ( moxibustion 24.79 + / -9.76 , UC 25.24 + / -8.84 , p = 0.0486 , effect size = 0.0021 ) were improved by moxibustion at 5 weeks .
RESULTS	The primary outcome improved for mild but not moderate-severe KOA .
RESULTS	At 13 weeks , moxibustion significantly improved the K-WOMAC global score and NRS .
RESULTS	Moxibustion improved SF-36 physical component summary ( p = 0.0299 ) , bodily pain ( p = 0.0003 ) , physical functioning ( p = 0.0025 ) and social functioning ( p = 0.0418 ) at 5 weeks , with no difference in mental component summary at 5 and 13 weeks .
RESULTS	BDI showed no difference ( p = 0.34 ) at 5 weeks .
RESULTS	After 1158 moxibustion treatments , 121 adverse events included first ( n = 6 ) and second degree ( n = 113 ) burns , pruritus and fatigue ( n = 2 ) .
CONCLUSIONS	Moxibustion may improve pain , function and quality of life in KOA patients , but adverse events are common .
CONCLUSIONS	Limitations included no sham control or blinding .
BACKGROUND	Clinical Research Information Service ( CRIS ) KCT0000130 .

###24831251
OBJECTIVE	To examine the speed and trajectory of changes in sleep/wake parameters during short-term treatment of insomnia with cognitive-behavioral therapy ( CBT ) alone versus CBT combined with medication ; and to explore the relationship between early treatment response and post-treatment recovery status .
METHODS	Participants were 160 adults with insomnia ( mean age , 50.3 years ; 97 women , 63 men ) who underwent a six-week course of CBT , singly or combined with 10 mg zolpidem nightly .
METHODS	The main dependent variables were sleep onset latency , wake after sleep onset , total sleep time , sleep efficiency , and sleep quality , derived from sleep diaries completed daily by patients throughout the course of treatment .
RESULTS	Participants treated with CBT plus medication exhibited faster sleep improvements as evidenced by the first week of treatment compared to those receiving CBT alone .
RESULTS	Optimal sleep improvement was reached on average after only one week for the combined treatment compared to two to three weeks for CBT alone .
RESULTS	Early treatment response did not reliably predict post-treatment recovery status .
CONCLUSIONS	Adding medication to CBT produces faster sleep improvement than CBT alone .
CONCLUSIONS	However , the magnitude of early treatment response is not predictive of final response after the six-week therapy .
CONCLUSIONS	Additional research is needed to examine mechanisms involved in this early treatment augmentation effect and its impact on long-term outcome .

###25349313
OBJECTIVE	Parapneumonic empyema ( PPE ) is a frequent complication of acute bacterial pneumonia in children .
OBJECTIVE	There is limited evidence regarding the optimal treatment of this condition .
OBJECTIVE	The aim of this study was to compare the efficacy of drainage plus urokinase versus video-assisted thoracoscopic surgery in the treatment of PPE in childhood .
METHODS	This prospective , randomized , multicenter clinical trial enrolled patients aged < 15 years and hospitalized with septated PPE .
METHODS	Study patients were randomized to receive urokinase or thoracoscopy .
METHODS	The main outcome variable was the length of hospital stay after treatment .
METHODS	The secondary outcomes were total length of hospital stay , number of days with the chest drain , number of days with fever , and treatment failures .
METHODS	The trial was approved by the ethics committees of all the participating hospitals .
RESULTS	A total of 103 patients were randomized to treatment and analyzed ; 53 were treated with thoracoscopy and 50 with urokinase .
RESULTS	There were no differences in demographic characteristics or in the main baseline characteristics between the 2 groups .
RESULTS	No statistically significant differences were found between thoracoscopy and urokinase in the median postoperative stay ( 10 vs 9 days ) , median hospital stay ( 14 vs 13 days ) , or days febrile after treatment ( 4 vs 6 days ) .
RESULTS	A second intervention was required in 15 % of children in the thoracoscopy group versus 10 % in the urokinase group ( P = .47 ) .
CONCLUSIONS	Drainage plus urokinase instillation is as effective as video-assisted thoracoscopic surgery as first-line treatment of septated PPE in children .

###24586717
BACKGROUND	The reported coverage of the measles-rubella ( MR ) or measles-mumps-rubella ( MMR ) vaccine is greater than 99.0 % in Zhejiang province .
BACKGROUND	However , the incidence of measles , mumps , and rubella remains high .
BACKGROUND	In this study , we assessed MMR seropositivity and disease distribution by age on the basis of the current vaccination program , wherein the first dose of MR is administered at 8 months and the second dose of MMR is administered at 18-24 months .
METHODS	Cross-sectional serological surveys of MMR antibodies were conducted by collecting epidemiological data in Zhejiang province , China in 2011 .
METHODS	In total , 1015 participants were randomly selected from two surveillance sites .
METHODS	Serum MMR-specific immunoglobulin G levels were tested by enzyme-linked immunosorbent assay .
METHODS	The geometric mean titers and seroprevalence with 95 % confidence intervals ( CIs ) were calculated by age and gender .
METHODS	Proportions of different dose of vaccine by age by vaccine were also identified .
METHODS	Statistically significant differences between categories were assessed by the Chi-square test .
RESULTS	Over 95 % seroprevalence rates of measles were seen in all age groups except < 7 months infants .
RESULTS	Children aged 5-9 years were shown lower seropositivity rates of mumps while elder adolescences and young adults were presented lower rubella seroprevalence .
RESULTS	Especially , rubella seropositivity was significantly lower in female adults than in male .
RESULTS	Nine measles cases were unvaccinated or unknown vaccination history .
RESULTS	Among them , 66.67 % ( 6/9 ) patients were aged 20-29 years while 33.33 % ( 3/9 ) were infants aged 8-12 months .
RESULTS	In addition , 57.75 % ( 648/1122 ) patients with mumps were children aged 5-9 years , and 50.54 % ( 94/186 ) rubella cases were aged 15-39 years .
CONCLUSIONS	A timely two-dose MMR vaccination schedule is recommended , with the first dose at 8 months and the second dose at 18-24 months .
CONCLUSIONS	An MR vaccination speed-up campaign may be necessary for elder adolescents and young adults , particularly young females .

###25213082
OBJECTIVE	The aim of this study was to investigate the effects of Kinesio Taping ( KT ) on the body functions and activity of children with unilateral spastic cerebral palsy ( CP ) .
METHODS	This study was designed as a single-blind , randomized , controlled trial .
METHODS	Thirty children with unilateral spastic CP were randomized and split equally between the KT group ( eight males , seven females ; mean age 9y [ SD 2y 3mo ] range 7-12y ) and the control group ( seven males , eight females ; mean age 9y 7mo [ SD 3y 4mo ] range 7-14y ) receiving usual care .
METHODS	All participants were evaluated with the Functional Independence Measure for Children ( WeeFIM ) , the Bruininks-Oseretsky Test of Motor Proficiency ( BOTMP ) , the Gross Motor Function Measure ( GMFM ) , short-term muscle power , agility and functional muscle strength tests .
METHODS	Wilcoxon signed-rank and Mann-Whitney U tests were used to evaluate within and between-group differences respectively .
METHODS	The level of significance was accepted as p < 0.05 .
RESULTS	There were significant differences in muscle power sprint ( p = 0.003 ) , lateral step-up test right ( p = 0.016 ) , sit to stand ( p = 0.018 ) , attain stand through half knee right ( p = 0.003 ) , BOTMP Gross scores ( p = 0.019 ) , and WeeFIM total ( p = 0.003 ) and self-care scores ( p = 0.022 ) between the groups ( p < 0.05 ) .
CONCLUSIONS	Kinesio Taping is a promising additional approach to increase proprioceptive feedback and improve physical fitness , gross motor function , and activities of daily living in children with CP .

###24698572
OBJECTIVE	To compare the clinical effects between closed reduction and internal fixation ( CRIF ) and total hip arthroplasty ( THA ) for displaced femoral neck fracture .
METHODS	In this prospective randomized study , 285 patients aged above 65 years with hip fractures ( Garden III or IV ) were included from January 2001 to December 2005 .
METHODS	The cases were randomly allocated to either the CRIF group or THA group .
METHODS	Patients with pathological fractures ( bone tumors or metabolic bone disease ) , preoperative avascular necrosis of the femoral head , osteoarthritis , rheumatoid arthritis , hemiplegia , long-term bed rest and complications affecting hip functions were excluded .
RESULTS	During the 5-year follow-up , CRIF group had significantly higher rates of complication in hip joint , general complication and reoperation than THA group ( 38.3 % vs. 12.7 % , P < 0.01 ; 45.3 % vs. 21.7 % , P < 0.01 ; 33.6 % vs. 10.2 % , P < 0.05 respectively ) .
RESULTS	There was no difference in mortality between the two groups .
RESULTS	Postoperative function of the hip joint in THA group recovered favorably with higher Harris scores .
CONCLUSIONS	For displaced fractures of the femoral neck in elderly patients , THA can achieve a lower rate of complication and reoperation , as well as better postoperative recovery of hip joint function compared with CRIF .

###25049329
OBJECTIVE	Induction chemotherapy ( IC ) before radiotherapy lowers distant failure ( DF ) rates in locally advanced squamous cell carcinoma of the head and neck ( SCCHN ) .
OBJECTIVE	The goal of this phase III trial was to determine whether IC before chemoradiotherapy ( CRT ) further improves survival compared with CRT alone in patients with N2 or N3 disease .
METHODS	Treatment-naive patients with nonmetastatic N2 or N3 SCCHN were randomly assigned to CRT alone ( CRT arm ; docetaxel , fluorouracil , and hydroxyurea plus radiotherapy 0.15 Gy twice per day every other week ) versus two 21-day cycles of IC ( docetaxel 75 mg/m ( 2 ) on day 1 , cisplatin 75 mg/m ( 2 ) on day 1 , and fluorouracil 750 mg/m ( 2 ) on days 1 to 5 ) followed by the same CRT regimen ( IC + CRT arm ) .
METHODS	The primary end point was overall survival ( OS ) .
METHODS	Secondary end points included DF-free survival , failure pattern , and recurrence-free survival ( RFS ) .
RESULTS	A total of 285 patients were randomly assigned .
RESULTS	The most common grade 3 to 4 toxicities during IC were febrile neutropenia ( 11 % ) and mucositis ( 9 % ) ; during CRT ( both arms combined ) , they were mucositis ( 49 % ) , dermatitis ( 21 % ) , and leukopenia ( 18 % ) .
RESULTS	Serious adverse events were more common in the IC arm ( 47 % v 28 % ; P = .002 ) .
RESULTS	With a minimum follow-up of 30 months , there were no statistically significant differences in OS ( hazard ratio , 0.91 ; 95 % CI , 0.59 to 1.41 ) , RFS , or DF-free survival .
CONCLUSIONS	IC did not translate into improved OS compared with CRT alone .
CONCLUSIONS	However , the study was underpowered because it did not meet the planned accrual target , and OS was higher than predicted in both arms .
CONCLUSIONS	IC can not be recommended routinely in patients with N2 or N3 locally advanced SCCHN .

###25376396
OBJECTIVE	To evaluate the effects and costs of three doses of behavioral weight-loss treatment delivered via Cooperative Extension Offices in rural communities .
METHODS	Obese adults ( N = 612 ) were randomly assigned to low , moderate , or high doses of behavioral treatment ( i.e. , 16 , 32 , or 48 sessions over two years ) or to a control condition that received nutrition education without instruction in behavior modification strategies .
RESULTS	Two-year mean reductions in initial body weight were 2.9 % ( 95 % Credible Interval = 1.7-4 .3 ) , 3.5 % ( 2.0-4 .8 ) , 6.7 % ( 5.3-7 .9 ) , and 6.8 % ( 5.5-8 .1 ) for the control , low - , moderate - , and high-dose conditions , respectively .
RESULTS	The moderate-dose treatment produced weight losses similar to the high-dose condition and significantly larger than the low-dose and control conditions ( posterior probability > 0.996 ) .
RESULTS	The percentages of participants who achieved weight reductions 5 % at two years were significantly higher in the moderate-dose ( 58 % ) and high-dose ( 58 % ) conditions compared with low-dose ( 43 % ) and control ( 40 % ) conditions ( posterior probability > 0.996 ) .
RESULTS	Cost-effectiveness analyses favored the moderate-dose treatment over all other conditions .
CONCLUSIONS	A moderate dose of behavioral treatment produced two-year weight reductions comparable to high-dose treatment but at a lower cost .
CONCLUSIONS	These findings have important policy implications for the dissemination of weight-loss interventions into communities with limited resources .

###25611315
BACKGROUND	Self-report questionnaires are an important method of evaluating lifespan health , exercise , and health-related quality of life ( HRQL ) outcomes among elite , competitive athletes .
BACKGROUND	Few instruments , however , have undergone formal characterization of their psychometric properties within this population .
OBJECTIVE	To evaluate the validity and reliability of a novel health and exercise questionnaire , the Trojan Lifetime Champions ( TLC ) Health Survey .
METHODS	Descriptive laboratory study .
METHODS	A large National Collegiate Athletic Association Division I university .
METHODS	A total of 63 university alumni ( age range , 24 to 84 years ) , including former varsity collegiate athletes and a control group of nonathletes .
METHODS	Participants completed the TLC Health Survey twice at a mean interval of 23 days with randomization to the paper or electronic version of the instrument .
METHODS	Content validity , feasibility of administration , test-retest reliability , parallel-form reliability between paper and electronic forms , and estimates of systematic and typical error versus differences of clinical interest were assessed across a broad range of health , exercise , and HRQL measures .
RESULTS	Correlation coefficients , including intraclass correlation coefficients ( ICCs ) for continuous variables and agreement statistics for ordinal variables , for test-retest reliability averaged 0.86 , 0.90 , 0.80 , and 0.74 for HRQL , lifetime health , recent health , and exercise variables , respectively .
RESULTS	Correlation coefficients , again ICCs and , for parallel-form reliability ( ie , equivalence ) between paper and electronic versions averaged 0.90 , 0.85 , 0.85 , and 0.81 for HRQL , lifetime health , recent health , and exercise variables , respectively .
RESULTS	Typical measurement error was less than the a priori thresholds of clinical interest , and we found minimal evidence of systematic test-retest error .
RESULTS	We found strong evidence of content validity , convergent construct validity with the Short-Form 12 Version 2 HRQL instrument , and feasibility of administration in an elite , competitive athletic population .
CONCLUSIONS	These data suggest that the TLC Health Survey is a valid and reliable instrument for assessing lifetime and recent health , exercise , and HRQL , among elite competitive athletes .
CONCLUSIONS	Generalizability of the instrument may be enhanced by additional , larger-scale studies in diverse populations .

###25147013
BACKGROUND	Physical therapy has not been evaluated much for the treatment of chronic venous insufficiency before .
BACKGROUND	The question is whether balneohydrotherapy and usual care combined is superior to usual care alone .
METHODS	In a randomized trial comparing spa therapy versus waiting list patients were treated on an out-patient basis in a private spa center .
METHODS	Patients had to be between 18 and 80 years old , with chronic venous insufficiency ( stage 3 or 4 according to the CEAP classification ) .
METHODS	The balneohydrotherapy group received 18 days of treatment in Aix-Les-Bains spa center continuing their usual care .
METHODS	The control group continued their usual care as well during the study .
METHODS	The balneohydrotherapy program consisted of Kneipp therapy ( 10 minutes ) , walking 10 minutes in a special mineral water pool with underwater jets at 23 C , massage and bathing in a mineral water tub at 34 C.
METHODS	The main outcome criterion was the number of patients with 20 % self assessed improvement on the Chronic Venous Insufficiency Questionnaire at three months after therapy .
RESULTS	192 patients were assessed for eligibility , 99 were randomized 5 retired drew back their consent and were not included in the intention to treat analysis .
RESULTS	None were lost to follow up .
RESULTS	After three months 32 ( 66 % ) patients improved in the balneohydrotherapy group and 13 ( 28 % ) in the control group .
RESULTS	The difference between groups was significant ( odd ratio 5.08 [ 1.94 - 13.55 ] , relative risk reduction 2.33 [ 1.42 - 3.84 ] ) .
RESULTS	There were no serious side effects .
CONCLUSIONS	Balneohydrotherapy seems to improve quality of life of patients with chronic venous insufficiency .

###24689367
OBJECTIVE	To determine the efficacy of prostaglandin administration during the proliferative phase in order to improve pregnancy rates following frozen embryo transfer during a hormone replacement cycle ( HRC ) .
METHODS	From September 2010 through March 2012 , patients ( n = 135 ) were recruited who had undergone oocyte retrieval during a stimulation cycle with clomiphene and had deferred fresh embryo transfer ( ET ) due to a thin uterine endometrium .
METHODS	All patients were less than 40 years of age and underwent thawed ET following all embryo cryopreservation , and were randomly divided into two groups for thawed ET using a conventional hormone replacement cycle with or without prostaglandin derivatives ( prostaglandin or conventional group ) .
METHODS	Prostaglandin derivatives were administrated during the proliferative phase .
METHODS	Pregnancy and implantation rates following frozen ET were compared between the two groups .
RESULTS	Although the endometrial thickness on the day of ET was similar for the prostaglandin and conventional groups , the pregnancy and implantation rates for the prostaglandin group were 40.0 % and 22.0 % , respectively , which was significantly higher than the rates for the conventional group ( P < 0.01 ) .
CONCLUSIONS	Among patients who avoided fresh ET due to a thin endometrium , the pregnancy rate following a thawed cycle was low .
CONCLUSIONS	However , it was improved when prostaglandin derivatives were used during the proliferative phase .

###24712855
BACKGROUND	Family-based treatment is an efficacious outpatient intervention for medically stable adolescents with anorexia nervosa .
BACKGROUND	Previous research suggests family-based treatment may be more effective for some families when parents and adolescents attend separate therapy sessions compared to conjoint sessions .
BACKGROUND	Our service developed a novel separated model of family-based treatment , parent-focused treatment , and is undertaking a randomised controlled trial to compare parent-focused treatment to conjoint family-based treatment .
METHODS	This randomised controlled trial will recruit 100 adolescents aged 12-18 years with DSM-IV anorexia nervosa or eating disorder not otherwise specified ( anorexia nervosa type ) .
METHODS	The trial commenced in 2010 and is expected to be completed in 2015 .
METHODS	Participants are recruited from the Royal Children 's Hospital Eating Disorders Program , Melbourne , Australia .
METHODS	Following a multidisciplinary intake assessment , eligible families who provide written informed consent are randomly allocated to either parent-focused treatment or conjoint family-based treatment .
METHODS	In parent-focused treatment , the adolescent sees a clinical nurse consultant and the parents see a trained mental health clinician .
METHODS	In conjoint family-based treatment , the whole family attends sessions with the mental health clinician .
METHODS	Both groups receive 18 treatment sessions over 6 months and regular medical monitoring by a paediatrician .
METHODS	The primary outcome is remission at end of treatment and 6 and 12 month follow up , with remission defined as being 95 % expected body weight and having an eating disorder symptom score within one standard deviation of community norms .
METHODS	The secondary outcomes include partial remission and changes in eating pathology , depressive symptoms and self-esteem .
METHODS	Moderating and mediating factors will also be explored .
CONCLUSIONS	This will be first randomised controlled trial of a parent-focused model of family-based treatment of adolescent anorexia nervosa .
CONCLUSIONS	If found to be efficacious , parent-focused treatment will offer an alternative approach for clinicians who treat adolescents with anorexia nervosa .
BACKGROUND	Australian and New Zealand Clinical Trials Registry ACTRN12610000216011 .

###24517899
BACKGROUND	Restoring patient homeostasis after coronary angiography , the gold standard diagnostic test for coronary heart disease is usually achieved by manual compression of the puncture site using a sandbag and prolonged bed rest .
BACKGROUND	However , this process frequently results in patient complaints of back pain and discomfort .
OBJECTIVE	The aim of study was to assess the effect of positioning on patient outcomes after coronary angiography .
METHODS	This study used a single-blind randomized control trial approach .
METHODS	The sample consisted of 80 patients who had undergone a nonemergency coronary angiography via the femoral artery .
METHODS	Balanced block randomization was used to allocate participants into intervention and control groups .
METHODS	Routine care for the intervention group ( n = 40 ) was adjusted to include the following : ( 1 ) intermittent changes to patient body and head position in bed during first 6 hours after catheterization , ( 2 ) reduction of sandbag compression time on the puncture site to 1 hour , and ( 3 ) regular examination for bleeding during the first 6 hours after catheterization .
METHODS	Intervention group participants were allowed to ambulate without restriction 6 hours after catheterization .
METHODS	Patients in the control group ( n = 40 ) received routine care , consisting of ( 1 ) 6-24 hours of bed rest in the supine position with the affected leg fixed straight and immobilized and ( 2 ) sandbag compression on the puncture site for 6 hours .
METHODS	The main outcomes used in this study were level of back pain , discomfort , foot pain , bleeding , and hematoma .
RESULTS	Intervention group patients had significantly less back pain and foot pain and higher comfort than the control group at the second , third , and sixth hour after catheterization ( p = .00 ) .
RESULTS	There was no significant difference between the two groups in terms of amount of bleeding and hematoma ( p > .05 ) .
CONCLUSIONS	Findings suggest that changes in patient position may be safer in the early period of postcatheterization bed rest than currently indicated in standard practice protocols .
CONCLUSIONS	Furthermore , limiting sandbag compression to 1 hour has no measurable effect on the incidence and severity of vascular complications .

###24640205
OBJECTIVE	The treatment of idiopathic nephrotic syndrome is still not well settled and at times is very frustrating .
OBJECTIVE	Number of protocols have been reported with variable results outcome in various conditions .
OBJECTIVE	The main pillar of treatment of idiopathic nephrotic syndrome is use of immunomodulating and suppressive drugs in various combinations .
OBJECTIVE	The herbal preparations have also been reported to have immunomodulating property .
OBJECTIVE	The study has been planned to record Immunomodulating and antiproteinuric effect of Hippophae rhamnoides .
METHODS	In the present study had 2 groups having 28 patients of idiopathic nephrotic syndrome in each group have been included .
METHODS	The patients were subjected to haematological , biochemical , immunological investigation at 0 , 1 , 2 and 3 months interval with dietic advise .
METHODS	Group A have been put on standard treatment , whereas group B on Badriphal in the well worked up doses .
METHODS	The hydroalcoholic extract of 350 mg twice daily of Badriphal was given to group B as add on treatment .
METHODS	Patients were followed up with definite protocol at monthly interval for 3 months .
RESULTS	At the end of 3 month patients showed improvement in the symptoms of oedema , anorexia , oliguria in the herbal group .
RESULTS	The urinary estimation of protein showed significant decrease in Group B with elevation of S. albumin levels .
RESULTS	The inflammatory cytokines has showed significant decrease at the end of 3 month .
CONCLUSIONS	Thus the pilot study showed beneficial effect of the herbal preparation Hippophae rhamnoides as add on treatment .
CONCLUSIONS	A large perspective study is recommended to establish these findings .

###25005333
OBJECTIVE	This study was performed to assess the effects of vitamin D and calcium supplementation on the metabolic profiles of vitamin D insufficient persons with type 2 diabetes .
METHODS	In a parallel designed randomised placebo-controlled clinical trial , a total of 118 non-smoker individuals with type 2 diabetes and insufficient 25-hydroxyvitamin D , aged > 30 years , were recruited from the Isfahan Endocrine and Metabolism Research Centre .
METHODS	Participants were randomly assigned to four groups receiving : ( 1 ) 50,000 U/week vitamin D + calcium placebo ; ( 2 ) 1,000 mg/day calcium + vitamin D placebo ; ( 3 ) 50,000 U/week vitamin D + 1,000 mg/day calcium ; or ( 4 ) vitamin D placebo + calcium placebo for 8 weeks .
METHODS	A study technician carried out the random allocations using a random numbers table .
METHODS	All investigators , participants and laboratory technicians were blinded to the random assignments .
METHODS	All participants provided 3 days of dietary records and 3 days of physical activity records throughout the intervention .
METHODS	Blood samples were taken to quantify glycaemic and lipid profiles at study baseline and after 8 weeks of intervention .
RESULTS	30 participants were randomised in each group .
RESULTS	During the intervention , one participant from the calcium group and one from the vitamin D group were excluded because of personal problems .
RESULTS	Calcium-vitamin D co-supplementation resulted in reduced serum insulin ( changes from baseline : -14.8 3.9 pmol/l , p = 0.01 ) , HbA1c [ -0.70 0.19 % ( -8.0 0.4 mmol/mol ) , p = 0.02 ] , HOMA-IR ( -0.46 0.20 , p = 0.001 ) , LDL-cholesterol ( -10.36 0.10 mmol/l , p = 0.04 ) and total/HDL-cholesterol levels ( -0.91 0.16 , p = 0.03 ) compared with other groups .
RESULTS	We found a significant increase in QUICKI ( 0.025 0.01 , p = 0.004 ) , HOMA of beta cell function ( HOMA-B ; 11.8 12.17 , p = 0.001 ) and HDL-cholesterol ( 0.46 0.05 mmol/l , p = 0.03 ) in the calcium-vitamin D group compared with others .
CONCLUSIONS	Joint calcium and vitamin D supplementation might improve the glycaemic status and lipid profiles of vitamin D insufficient people with type 2 diabetes .
BACKGROUND	ClinicalTrials.gov NCT01662193 FUNDING : Clinical Research Council , Isfahan University of Medical Sciences , Isfahan , Iran .

###24424705
OBJECTIVE	Various genetic polymorphisms have been reported to be associated with antipsychotic-induced weight gain .
OBJECTIVE	In this study , we aimed to determine whether risk polymorphisms in 12 candidate genes are associated with reduction in body mass index ( BMI ) of patients following switching of antipsychotics to aripiprazole or ziprasidone .
METHODS	We recruited 115 schizophrenia patients with metabolic abnormalities and who have been on at least 1year treatment with other antipsychotics ; they were then switched to either aripiprazole or ziprasidone .
METHODS	They were genotyped , and their BMI monitored for 6 months .
RESULTS	Significant associations with reduction in BMI at 6months following switching were found in two of these genes : with rs1800544 of the ADRA2A gene ( CC+CG [ -0.321.41 kg/m ] vs GG [ -1.041.63 kg/m ] , p = 0.013 ) and with rs1801131 of the MTHFR gene ( AA [ -0.361.53 ] vs AC+CC [ -1.071.53 ] , p = 0.015 ) .
CONCLUSIONS	The study data indicated that carriage of the ADRA2A rs1800544 GG genotype and the MTHFR rs1801131 C allele are associated with BMI reduction in this population following switching of antipsychotics to aripiprazole and ziprasidone .

###25345483
BACKGROUND	Total hip replacement provides pain relief and improves physical function and quality of life in patients with end-stage hip osteoarthritis .
BACKGROUND	The incidence of hip replacement operations is expected to increase due to the growing elderly population .
BACKGROUND	Overall , the posterior approach and lateral approach are the two most commonly used approaches for hip replacement operations .
BACKGROUND	The posterior approach is associated with an increased risk of revision due to dislocations , and some studies have shown that the lateral approach is associated with reduced patient-reported outcomes , including physical function and pain ; however , this has not been investigated in a randomised controlled trial with a twelve-month follow-up .
BACKGROUND	We hypothesized that the lateral approach has an inferior outcome in patient-reported outcome compared with the posterior approach after one year .
METHODS	The trial is a prospective , double blinded , parallel-group controlled trial with balanced randomisation [ 1 : 1 ] .
METHODS	Patients with hip osteoarthritis scheduled for hip replacement surgery , aged 45-70 years , will be consecutively recruited and randomised into two groups .
METHODS	Group A will receive hip replacement using the posterior approach , and Group B will receive hip replacement using the lateral approach .
METHODS	The primary end-point for assessing the outcome of the two interventions will be twelve months after surgery .
METHODS	Follow-up will also be performed after three and six months .
METHODS	The primary outcome is Hip Disability and Osteoarthritis Outcome Score , subscale of `` Physical function Short form '' ( HOOS-PS ) Secondary outcome measures include two other subscales of HOOS ( `` Pain '' and `` Hip related Quality of Life '' ) , physical activity level ( UCLA activity score ) , limping ( HHS ) and general health status ( EQ-5D-3L ) .
METHODS	Explorative outcomes include physical function test , 3D-gait-analysis and muscle strength .
CONCLUSIONS	To our knowledge , this is the first randomised controlled trial comparing the posterior approach with the lateral approach with patient reported outcome as the primary outcome and with a twelve-month follow-up .
BACKGROUND	Clinicaltrial.gov : NCT01616667 .

###24530144
OBJECTIVE	This study tests the effectiveness of motivational interviewing compared with the usual care for Chinese hypertensive patients .
METHODS	A randomised controlled trial was used .
METHODS	One hundred and twenty eligible participants were randomly assigned to either the control group ( usual care group ) or the intervention group ( motivational interviewing group ) .
RESULTS	The results of this study demonstrated that the total scores and the mean scores for each dimension of the adherence questionnaire were increased in the intervention group ( P < 0.05 ) , and the systolic blood pressure and diastolic blood pressure of the hypertensive patients greatly decreased in the intervention group during the six months of the motivational interviewing counselling ( P < 0.05 ) .
CONCLUSIONS	The application of motivational interviewing for hypertensive patients is a promising approach for sustaining the clinical benefits of adherence behaviour .
CONCLUSIONS	Motivational interviewing should be provided to hypertensive patients at hospitals and community health centres to assist patients in controlling their BP and to enhance treatment adherence .
CONCLUSIONS	A series of training courses on the motivational interviewing technique should be provided to nurses .

###24836205
BACKGROUND	Ataluren was developed to restore functional protein production in genetic disorders caused by nonsense mutations , which are the cause of cystic fibrosis in 10 % of patients .
BACKGROUND	This trial was designed to assess the efficacy and safety of ataluren in patients with nonsense-mutation cystic fibrosis .
METHODS	This randomised , double-blind , placebo-controlled , phase 3 study enrolled patients from 36 sites in 11 countries in North America and Europe .
METHODS	Eligible patients with nonsense-mutation cystic fibrosis ( aged 6 years ; abnormal nasal potential difference ; sweat chloride > 40 mmol/L ; forced expiratory volume in 1 s [ FEV1 ] 40 % and 90 % ) were randomly assigned by interactive response technology to receive oral ataluren ( 10 mg/kg in morning , 10 mg/kg midday , and 20 mg/kg in evening ) or matching placebo for 48 weeks .
METHODS	Randomisation used a block size of four , stratified by age , chronic inhaled antibiotic use , and percent-predicted FEV1 .
METHODS	The primary endpoint was relative change in percent-predicted FEV1 from baseline to week 48 , analysed in all patients with a post-baseline spirometry measurement .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00803205 .
RESULTS	Between Sept 8 , 2009 , and Nov 30 , 2010 , 238 patients were randomly assigned , of whom 116 in each treatment group had a valid post-baseline spirometry measurement .
RESULTS	Relative change from baseline in percent-predicted FEV1 did not differ significantly between ataluren and placebo at week 48 ( -2.5 % vs -5.5 % ; difference 3.0 % [ 95 % CI -0.8 to 6.3 ] ; p = 0.12 ) .
RESULTS	The number of pulmonary exacerbations did not differ significantly between treatment groups ( rate ratio 0.77 [ 95 % CI 0.57-1 .05 ] ; p = 0.0992 ) .
RESULTS	However , post-hoc analysis of the subgroup of patients not using chronic inhaled tobramycin showed a 5.7 % difference ( 95 % CI 1.5-10 .1 ) in relative change from baseline in percent-predicted FEV1 between the ataluren and placebo groups at week 48 ( -0.7 % [ -4.0 to 2.1 ] vs -6.4 % [ -9.8 to -3.7 ] ; nominal p = 0.0082 ) , and fewer pulmonary exacerbations in the ataluern group ( 1.42 events [ 0.9-1 .9 ] vs 2.18 events [ 1.6-2 .7 ] ; rate ratio 0.60 [ 0.42-0 .86 ] ; nominal p = 0.0061 ) .
RESULTS	Safety profiles were generally similar for ataluren and placebo , except for the occurrence of increased creatinine concentrations ( ie , acute kidney injury ) , which occurred in 18 ( 15 % ) of 118 patients in the ataluren group compared with one ( < 1 % ) of 120 patients in the placebo group .
RESULTS	No life-threatening adverse events or deaths were reported in either group .
CONCLUSIONS	Although ataluren did not improve lung function in the overall population of nonsense-mutation cystic fibrosis patients who received this treatment , it might be beneficial for patients not taking chronic inhaled tobramycin .
BACKGROUND	PTC Therapeutics , Cystic Fibrosis Foundation , US Food and Drug Administration 's Office of Orphan Products Development , and the National Institutes of Health .

###24627899
BACKGROUND	Treatment of idiopathic headshaking in horses is complicated by an incomplete understanding of underlying pathophysiology and partially effective treatments .
BACKGROUND	If an inflammatory etiology exists , corticosteroids could be beneficial .
OBJECTIVE	An anti-inflammatory dose of dexamethasone reduces the signs of idiopathic headshaking in a field setting .
METHODS	Convenience sample of 20 adult horses with idiopathic headshaking syndrome .
METHODS	Cases were recruited from the general population and diagnosed by attending veterinarians .
METHODS	Prospective , blinded clinical trial .
METHODS	Pulsed dosing was with oral dexamethasone ( 60 mg PO Q24h 4 days , q3 weeks for 4 months ) or placebo ( inert paste ) .
METHODS	Owners were blinded and asked to score the headshaking from 0 to 4 ( 4 = most severe ) 3 days per week .
METHODS	The change in headshaking scores ( HS ) over each treatment pulse was compared between groups by ordinal logistic regression .
RESULTS	Twelve horses completed the trial .
RESULTS	There was no significant difference between treated or placebo horses ( P = .987 ) .
RESULTS	Sun ( P .001 ) , wind ( P = .028 ) , and exercise ( P .045 ) significantly increased HS .
CONCLUSIONS	No benefit of dexamethasone treatment was detected for idiopathic headshaking .
CONCLUSIONS	The results confirmed previous reports of common triggers for headshaking behavior

###24739135
BACKGROUND	Stenosis of the internal carotid artery has been associated with cognitive impairment and decline .
BACKGROUND	However , studies testing the effect of carotid revascularisation on cognition have had conflicting results .
BACKGROUND	This may in part be explained by variation in the flow territory of the carotid artery .
BACKGROUND	In 12 to 36 % of the patients , the posterior cerebral artery is mainly or exclusively supplied by the internal carotid artery via a foetal-type posterior cerebral artery .
BACKGROUND	In these patients , ipsilateral carotid artery stenosis is likely to result in a larger area with hypoperfusion than in case of a normal posterior cerebral artery .
BACKGROUND	Patients with a foetal-type posterior cerebral artery could therefore benefit more from revascularisation .
BACKGROUND	We compared the effects of carotid revascularisation on cognition between patients with a foetal-type and those with a normal posterior cerebral artery .
METHODS	Patients with symptomatic internal carotid artery stenosis50 % , enrolled in the International Carotid Stenting Study ( ICSS ) at a single centre , underwent detailed neuropsychological examinations before and 6 months after revascularisation .
METHODS	Cognitive test results were standardized into z-scores , from which a cognitive sumscore was calculated .
METHODS	The primary outcome was the change in cognitive sumscore between baseline and follow-up .
METHODS	Changes in cognitive sumscore were compared between patients with an ipsilateral foetal-type and those with a normal posterior cerebral artery , as assessed with CT or MR angiography .
RESULTS	Of 145 patients enrolled in ICSS at the centre during the study period , 98 had both angiography at baseline and neuropsychological examination at baseline and at 6-months follow-up .
RESULTS	The cognitive sum score decreased by 0.28 ( 95 % confidence interval , 0.10 to 0.45 ) in 13 patients with an ipsilateral foetal-type posterior cerebral artery and by 0.07 ( 95 % CI , 0.002 to 0.15 ) in 85 patients with a normal posterior cerebral artery ( mean difference , -0.20 ; 95 % CI , -0.40 to -0.01 ) .
RESULTS	This did not change essentially after adjustment for baseline factors .
CONCLUSIONS	An ipsilateral foetal-type posterior cerebral artery appears to increase cognitive decline after carotid revascularisation .
CONCLUSIONS	Our findings have to be reproduced in an independent study before further implications can be made .

###24680626
BACKGROUND	Outpatient nonhospice palliative care has been shown to provide many benefits to patients facing advanced illness , but such services remain uncommon in the U.S. Little is known about the association between clinic-based outpatient palliative care consultation and the timing of hospice enrollment .
OBJECTIVE	To determine whether there are differences in hospice length of service ( LOS ) between patients who were seen vs. patients who were not seen in an outpatient palliative care clinic before enrollment in hospice .
METHODS	Using a retrospective study of medical records , a `` prior palliative care clinic '' group was formed of those hospice patients who had had a nonhospice clinic-based outpatient palliative care consult before hospice admission ( n = 354 ) .
METHODS	For those patients , `` control '' hospice patients without prior clinic-based palliative care were chosen who were matched by age , gender , median income of their zip code , and diagnostic group .
METHODS	Both groups were restricted to patients who died while enrolled in hospice .
METHODS	LOS for these two groups was compared using standard statistical methods of survival analysis .
RESULTS	Prior palliative care clinic patients had a median LOS of 24 days , whereas control patients had a median LOS of 15 days ( 95 % CI for difference between the medians 5-13 days ) .
RESULTS	The difference between the LOS distribution curves was statistically significant by the log-rank test ( P < 0.001 ) .
CONCLUSIONS	Hospice patients who had clinic-based outpatient palliative consults before hospice enrollment tended , on average , to have a longer LOS in hospice than patients who did not .

###25539654
BACKGROUND	This study evaluated the effects of aclidinium bromide , a long-acting muscarinic antagonist indicated for maintenance treatment of chronic obstructive pulmonary disease ( COPD ) , on exercise endurance , dyspnea , lung hyperinflation , and physical activity .
METHODS	In this randomized , double-blind , crossover study , patients with stable COPD and moderate-to-severe airflow limitation received aclidinium 400 g twice daily or placebo via Genuair/Pressair ( a ) for 3 weeks ( 2-week washout between treatment periods ) .
METHODS	The primary endpoint was change from baseline to Week 3 in endurance time , measured by constant work rate cycle ergometry testing at 75 % peak incremental work rate .
METHODS	Changes from baseline in intensity of exertional dyspnea ( Borg CR10 Scale ) and trough inspiratory capacity were secondary endpoints .
METHODS	Additional endpoints included changes from baseline in other spirometric , plethysmographic , and physical activity ( assessed by objective accelerometer measurement ) parameters .
METHODS	Efficacy endpoints were analyzed using an analysis of covariance model .
RESULTS	In total , 112 patients were randomized and treated ( mean age 60.3 years ; mean post-bronchodilator forced expiratory volume in 1 s 1.7 L [ 56.7 % predicted ] ; mean endurance time 485.7 s ) .
RESULTS	After 3 weeks , endurance time was significantly increased with aclidinium versus placebo ( treatment difference 58.5 s ; p < 0.05 ) .
RESULTS	At Week 3 , aclidinium significantly reduced dyspnea intensity at isotime during exercise ( treatment difference -0.63 ; p < 0.05 ) and improved trough inspiratory capacity ( treatment difference 78 mL ; p < 0.05 ) versus placebo .
RESULTS	Significant improvements in spirometric , plethysmographic , and some physical activity parameters were observed with aclidinium versus placebo .
CONCLUSIONS	These results suggest that aclidinium significantly improves exercise endurance , exertional dyspnea , hyperinflation , and physical activity in patients with COPD .
BACKGROUND	ClinicalTrials.gov identifier : NCT01471171 ; URL : http://www.clinicaltrials.gov .

###25110280
OBJECTIVE	Canagliflozin is a sodium glucose co-transporter 2 inhibitor approved for treating patients with type 2 diabetes .
OBJECTIVE	This study evaluated renal and non-renal effects of canagliflozin on postprandial plasma glucose ( PG ) excursion in patients with type 2 diabetes inadequately controlled with metformin .
METHODS	Patients ( N = 37 ) were randomized to a four-period crossover study with 3-day inpatient stays in each period and 2-week wash-outs between periods .
METHODS	Patients received Treatments ( A ) placebo/placebo , ( B ) canagliflozin 300 mg/placebo , ( C ) canagliflozin 300 mg/canagliflozin 300 mg , or ( D ) canagliflozin 300 mg/canagliflozin 150 mg on Day 2/Day 3 in one of four treatment sequences ( similar urinary glucose excretion [ UGE ] expected for Treatments B-D ) .
METHODS	A mixed-meal tolerance test ( MMTT ) was given 20 minutes post-dose on Day 3 of each period .
RESULTS	A single dose of canagliflozin 300 mg reduced both fasting and postprandial PG compared with placebo , with generally similar effects on fasting PG and UGE observed for Treatments B-D .
RESULTS	An additional dose of canagliflozin 300 mg ( Treatment C ) , but not 150 mg ( Treatment D ) , prior to the MMTT on Day 3 provided greater postprandial PG reduction versus placebo ( difference in incremental glucose AUC0-2h , -7.5 % for B vs A ; -18.5 % for C vs A ; -12.0 % [ P = 0.012 ] for C vs B ) , leading to modestly greater reductions in total glucose AUC0-2h with Treatment C versus Treatment B or D. Canagliflozin was generally well tolerated .
CONCLUSIONS	These findings suggest that a non-renal mechanism ( ie , beyond UGE ) contributes to glucose lowering for canagliflozin 300 mg , but not 150 mg .

###25751447
BACKGROUND	This study aimed to explore the effects of massage on the state anxiety of patients receiving percutaneous coronary intervention ( PCI ) .
METHODS	In accordance with the principle of the minimum allocation of imbalance index for comparability , a total of 117 cases that were ready to receive PCI were divided into two groups ( 59 in the intervention group and 58 in the control group ) .
METHODS	The patients in the control group received routine care , whereas the patients in the observation group were given massage intervention .
METHODS	The state anxiety , heart rate , and blood pressure of the two groups were observed and compared .
RESULTS	Massage treatments reduced the emergency response and level of anxiety of cardiovascular patients before PCI .
RESULTS	The post-intervention blood pressure , heart rate , and pain score of the intervention group were significantly better than those of the control group ( P < 0.05 ) .
CONCLUSIONS	Health professionals should pay attention to and strengthen the exploration of the effects of reasonable care intervention mode under PCI to promote the physical and mental health of patients , as well as improve their medical care satisfaction .

###25596881
BACKGROUND	A substantial proportion of patients with Parkinson 's disease ( PD ) have concomitant cognitive dysfunction .
BACKGROUND	Identification of biomarker profiles that predict which PD patients have a greater likelihood for progression of cognitive symptoms is pressingly needed for future treatment and prevention approaches .
METHODS	Subjects were drawn from the Deprenyl and Tocopherol Antioxidative Therapy of Parkinsonism ( DATATOP ) study , a large clinical trial that enrolled initially untreated PD patients .
METHODS	For the current study , Phase One encompassed trial baseline until just prior to levodopa administration ( n = 403 ) , and Phase Two spanned the initiation of levodopa treatment until the end of cognitive follow-up ( n = 305 ) .
METHODS	Correlations and linear mixed models were performed to determine cross-sectional and longitudinal associations between baseline amyloid 1-42 ( A42 ) , total tau ( t-tau ) , and phosphorylated tau ( p-tau ) in cerebrospinal fluid ( CSF ) and measures of memory and executive function .
METHODS	Analyses also considered APOE genotype and tremor - vs. rigidity-dominant phenotype .
RESULTS	No association was found between baseline CSF biomarkers and cognitive test performance during Phase One .
RESULTS	However , once levodopa treatment was initiated , higher p-tau and p-tau/A42 predicted subsequent decline on cognitive tasks involving both memory and executive functions .
RESULTS	The interactions between biomarkers and cognition decline did not appear to be influenced by levodopa dosage , APOE genotype or motor phenotype .
CONCLUSIONS	The current study has , for the first time , demonstrated the possible involvement of tau species , whose gene ( MAPT ) has been consistently linked to the risk of PD by genome-wide association studies , in the progression of cognitive symptoms in PD .

###24988100
OBJECTIVE	The objective of this study was to determine whether a mindfulness program , created for the workplace , was both practical and efficacious in decreasing employee stress while enhancing resiliency and well-being .
METHODS	Participants ( 89 ) recruited from The Dow Chemical Company were selected and randomly assigned to an online mindfulness intervention ( n = 44 ) or wait-list control ( n = 45 ) .
METHODS	Participants completed the Perceived Stress Scale , the Five Facets of Mindfulness Questionnaire , the Connor-Davidson Resiliency Scale , and the Shirom Vigor Scale at pre - and postintervention and 6-month follow-up .
RESULTS	The results indicated that the mindfulness intervention group had significant decreases in perceived stress as well as increased mindfulness , resiliency , and vigor .
CONCLUSIONS	This online mindfulness intervention seems to be both practical and effective in decreasing employee stress , while improving resiliency , vigor , and work engagement , thereby enhancing overall employee well-being .

###24763133
OBJECTIVE	The 47 integrin monoclonal antibody vedolizumab is hypothesised to be gut selective .
OBJECTIVE	Effects of vedolizumab on immune responses to parenterally or enterally administered antigens were investigated .
METHODS	In this randomised , double-blind , placebo-controlled , phase I trial , healthy participants received a single intravenous dose of vedolizumab 750mg ( n = 64 ) or placebo ( n = 63 ) .
METHODS	After 4days , participants began intramuscular hepatitis B vaccine ( HBV ; days 4 , 32 , 60 ) and oral cholera vaccine ( OCV ; days 4 , 18 ) regimens .
METHODS	The study was designed to demonstrate a 15 % non-inferiority margin for the between-group difference in the primary end point : percentage of participants with HBV seroconversion at day 74 ( serum hepatitis B surface antigen ( HBs ) antibody titre 10IU/L ) .
METHODS	OCV seroconversion at day 74 ( > 4-fold increase in serum cholera toxin ( CT ) antibodies ) was a secondary end point .
RESULTS	A total of 56 ( 90.3 % ) placebo-treated and 54 ( 88.5 % ) vedolizumab-treated participants responded to HBV .
RESULTS	Geometric mean anti-HBs titres were similar for placebo ( 114.4 IU/L ) and vedolizumab ( 129.6 IU/L ) at day 74 .
RESULTS	A total of 60 ( 96.8 % ) placebo-treated and 52 ( 82.5 % ) vedolizumab-treated participants responded to OCV at day 74 .
RESULTS	Geometric mean anti-CT IgG levels were higher for placebo than for vedolizumab at day 74 ( 9210.08 vs. 3007.8 ELISA Units ( EU ) / mL ) and day 32 ( 11629.3 vs. 1575.4 EU/mL ) .
RESULTS	Anti-CT IgA results were similar .
RESULTS	Adverse events were consistent with previous experience .
RESULTS	One serious adverse event ( spontaneous abortion ) was reported for placebo .
CONCLUSIONS	Vedolizumab did not alter the response to parenterally administered antigens but reduced the response to oral antigens , demonstrating its gut-selective mechanism of action .
BACKGROUND	NCT Number : 01981616 ; EudraCT Number : 2011-001874-24 .

###24727123
OBJECTIVE	In a Japanese Phase II study , the hepatitis C virus NS3/4A protease inhibitor simeprevir demonstrated potent antiviral activity and significantly improved sustained virologic response rates when added to peginterferon -2 a/ribavirin in treatment-nave patients infected with hepatitis C virus genotype 1 .
METHODS	CONCERTO-1 was a Phase III , randomized , double-blind , placebo-controlled trial .
METHODS	Treatment-nave adults ( 70 years ) with chronic hepatitis C virus genotype 1 infection ( hepatitis C virus RNA 5 log10 IU/ml ) were randomized ( 2:1 ) to simeprevir 100mg once-daily with peginterferon -2 a/ribavirin for 12 weeks then response-guided therapy with peginterferon -2 a/ribavirin for 12 or 36 weeks , or to placebo with peginterferon -2 a/ribavirin for 12 weeks then peginterferon -2 a/ribavirin for 36 weeks .
RESULTS	Overall , 183 patients were treated .
RESULTS	Sustained virologic response 12 weeks after treatment end ( primary efficacy endpoint ) was achieved in 88.6 % of simeprevir - and 61.7 % of placebo-treated patients ( p < 0.0001 for stratum-adjusted between-group difference ) .
RESULTS	Overall , 91.9 % of simeprevir-treated patients met response-guided therapy criteria and completed treatment at week 24 ; sustained virologic response rate at 12 weeks in these patients was 92.0 % .
RESULTS	One simeprevir - ( 0.8 % ) and two placebo-treated patients ( 3.3 % ) experienced viral breakthrough ; respective viral relapse rates were 7.6 % and 30.6 % .
RESULTS	Overall adverse event profile in simeprevir-treated patients was comparable to that in patients who received peginterferon -2 a/ribavirin alone .
CONCLUSIONS	Simeprevir once daily with peginterferon -2 a/ribavirin significantly improved sustained virologic response rate 12 weeks after treatment end in treatment-nave patients with chronic hepatitis C virus genotype 1 infection , with a shorter 24-week treatment duration in most patients .

###24434527
OBJECTIVE	The treatment of bipolar disorder type I ( BD-I ) with a comorbid cocaine dependence disorder ( CDD ) is a challenge in current psychiatric practice .
OBJECTIVE	Drugs with proven efficacy in manic/mixed episodes , such as atypical antipsychotics and mood stabilizers , sometimes do not prevent depressive relapses ; on the other hand , the use of antidepressants during acute depressive episodes may increase the risk of a manic switch .
OBJECTIVE	The aim of the present study was to investigate the short-term efficacy of bupropion augmentation in acutely depressed BD-I patients with co-occurring CDD .
METHODS	Twelve depressed BD-I patients , with a comorbid CDD , treated with valproate 1000 to 1500 mg/d and aripiprazole 10 mg/d , were randomly assigned to receive bupropion 150 mg/d as an open-label add-on therapy ( n = 5 ) or to continue their previous treatment ( n = 7 ) .
RESULTS	After 4 weeks of observation , patients receiving add-on therapy with bupropion have improved in terms of Hamilton Depression Rating Scale scores and Drug Abuse Screening Test scores , with respect to those of the comparison group , whereas no significant increase of Young Mania Rating Scale scores over time was observed .
CONCLUSIONS	Our preliminary findings suggest that combining bupropion with mood stabilizers and atypical antipsychotics may be a good therapeutic option in short-term treatment of depressed BD-I patients with comorbid CDD .

###24848990
BACKGROUND	Previous analysis of a single data set in acute pain following third molar extraction demonstrated a strong relationship between the speed of reduction of pain intensity and overall pain relief , as well as need for additional analgesia .
METHODS	Individual patient data analysis of a single randomized , double-blind trial of placebo , paracetamol 1000 mg , ibuprofen sodium 400 mg and ibuprofen-poloxamer 400 mg following third molar extraction .
METHODS	Visual analogue scale pain intensity ( VASPI ) and other measurements were made at baseline , every 5-45 min , and at 60 , 90 , 120 , 180 , 240 , 300 and 360 min .
RESULTS	Most patients produced consistent VASPI results over time .
RESULTS	For placebo and paracetamol , few patients achieved low VASPI scores and maintained them .
RESULTS	For both ibuprofen formulations , VASPI scores fell rapidly during the first hour and were then typically maintained until later re-medication .
RESULTS	Analysis of all patients showed that rapid VASPI reduction in the first hour was strongly correlated with good overall pain relief ( high total pain relief over 0-6 h ) , and with lesser need for additional analgesia within 6 h. Results for this analysis were in very good agreement with a previous analysis , validating the relationship between fast initial pain intensity reduction and overall good pain relief in this setting .
CONCLUSIONS	In acute pain following third molar extraction , faster acting analgesic formulations provide earlier onset of pain relief , better overall pain relief and a less frequent need for additional analgesia , indicating longer lasting pain relief .

###24690118
OBJECTIVE	To determine the effects of subanesthetic ketamine in dogs with pyometra on C-reactive protein ( CRP ) concentrations following surgery .
METHODS	Prospective , nonconcealed , alternating allocation controlled trial .
METHODS	Veterinary teaching hospital .
METHODS	Sixteen dogs diagnosed with pyometra .
METHODS	The tentative diagnosis of canine pyometra was based on compatible history , physical examination findings , ultrasonographic findings , and hematological evaluation .
METHODS	Two different anesthesia and analgesic protocols with and without low-dose ketamine were used during and following ovariohysterectomy in 16 female dogs ( n = 8 per group ) that were diagnosed with naturally occurring pyometra .
METHODS	Dogs were sequentially allocated to treatment groups in an alternating fashion without concealment .
METHODS	Serum was collected before , 24 , and 48 hours after surgery for CRP measurement .
RESULTS	Perioperative physical parameters in the 2 groups of dogs were similar .
RESULTS	The serum concentrations of CRP in both groups were essentially the same before surgery , but significantly increased in the control group and decreased in ketamine group at 48 hours after surgery .
CONCLUSIONS	Low-dose ketamine attenuated the postoperative concentration of serum CRP in dogs with pyometra compared with dogs that did not receive ketamine in the perioperative period .
CONCLUSIONS	Further studies are warranted to determine the clinical implications of these findings .

###25056208
BACKGROUND	In the United States certain minority groups , such as racial/ethnic immigrant women , are less likely than non-Hispanic White women to be screened for cervical cancer .
BACKGROUND	Barriers to such care include health insurance , cost , knowledge , attitudes , health literacy , and cultural norms and practices .
BACKGROUND	Among the most promising approaches to increase screening in these groups are patient navigators that can link women to sources of appropriate care .
BACKGROUND	Another recent promising approach is using human papilloma virus ( HPV ) self-sampling .
BACKGROUND	In this manuscript , we describe our National Cancer Institute-sponsored study testing such approaches among immigrant minority women .
METHODS	The South Florida Center for the Reduction of Cancer Health Disparities ( SUCCESS ) is conducting a three-arm randomized trial among Hispanic , Haitian , and African American women in Miami-Dade County .
METHODS	Community health workers ( CHW ) based in each of three communities are recruiting 200 women at each site ( 600 total ) .
METHODS	Eligibility criteria include women aged 30-65 years who have not had a Pap smear test in the last 3years .
METHODS	Prior to randomization , all women undergo a standardized structured interview .
METHODS	Women randomized to public health outreach , Group 1 , receive culturally tailored educational materials .
METHODS	Women in Group 2 receive an individualized comprehensive cervical cancer CHW-led education session followed by patient navigation to obtain the Pap smear test at community-based facilities .
METHODS	Women in Group 3 have the option of navigation to a Pap smear test or performing HPV self-sampling .
METHODS	The primary outcome is self-report of completed screening through a Pap smear test or HPV self-sampling within 6months after enrollment .
CONCLUSIONS	SUCCESS is one of the first trials testing HPV self-sampling as a screening strategy among underserved minority women .
CONCLUSIONS	If successful , HPV self-sampling may be an important option in community outreach programs aimed at reducing disparities in cervical cancer .
BACKGROUND	Clinical Trials.gov # NCT02121548 , registered April 21 , 2014 .

###25560100
OBJECTIVE	To compare postoperative pain scores and assess efficacy between an adjustable single-incision sling and a standard transobturator sling for stress urinary incontinence ( SUI ) .
METHODS	This single-blinded randomized controlled trial involved 156 women with clinically proven SUI .
METHODS	Women were allocated to receive either an adjustable single-incision or a transobturator sling .
METHODS	The primary outcome was postoperative pain score on a visual analog scale .
METHODS	Secondary outcomes were objective and subjective cure rates at 12 months , symptom bother scores , quality of life , and complications .
RESULTS	The mean pain score in the first week postoperatively was significantly lower at all time points in the adjustable single-incision sling group compared with the transobturator sling group .
RESULTS	Maximum difference in pain score was reported on the evening of the day of surgery ; median pain score was 1.0 ( interquartile range 2.0 ) in the adjustable sling group and 3.0 ( interquartile range 4.5 ) in the transobturator sling group ( Mann Whitney U test P < .001 ) .
RESULTS	There was no statistical difference in analgesic use .
RESULTS	The objective cure rates in the adjustable single-incision sling and in the transobturator sling group were 90.8 % and 88.6 % ( P = .760 ) , and the subjective cure rates were 77.2 % and 72.9 % ( P = .577 ) , respectively .
RESULTS	No difference in the complication rate was found .
CONCLUSIONS	An adjustable single-incision sling for the treatment of SUI is associated with lower early postoperative pain scores but shows comparable cure rates with a transobturator at 12 months of follow-up .
BACKGROUND	Netherlands Trial Register , http://www.trialregister.nl , NTR : 2558 .
METHODS	I.

###25406552
OBJECTIVE	To investigate the preventive effect of behavioral therapy plus flunarizine in children with migraine .
METHODS	Ninety pediatric patients with migraine between January 2011and January 2014 were randomly divided into treatment group ( 45 cases ) and control group ( 45 cases ) .
METHODS	The treatment group received behavioral therapy in addition to oral flunarizine , while the control group received oral flunarizine alone .
METHODS	All patients were followed up for 3 months to evaluate the therapeutic effect by the Pediatric Migraine Disability Assessment Score ( PedMIDAS ) and improved Bussone headache index .
RESULTS	There were no significant differences in PedMIDAS ( P > 0.05 ) and improved Bussone headache index ( P > 0.05 ) between the control and treatment groups before treatment .
RESULTS	Significant differences were observed in PedMIDAS ( 168 vs 2010 ; P < 0.05 ) and improved Bussone headache index ( 2518 vs 3721 ; P < 0.05 ) between the two groups after 3 months of treatment .
CONCLUSIONS	Preventive treatment of behavioral therapy plus oral flunarizine shows a better clinical efficacy than oral flunarizine alone in children with migraine and holds promise for clinical application .

###24522786
BACKGROUND	Uncontrolled asthma during pregnancy is associated with maternal and perinatal hazards .
BACKGROUND	A pharmacist-led intervention directed at improving maternal asthma control , involving multidisciplinary care , education , and regular monitoring to help reduce these risks , was developed and evaluated .
METHODS	A randomized controlled trial was carried out in the antenatal clinics of two major Australian maternity hospitals .
METHODS	Sixty pregnant women < 20 weeks gestation who had used asthma medications in the previous year were recruited .
METHODS	Participants were randomized to either an intervention or a usual care group and followed prospectively throughout pregnancy .
METHODS	The primary outcome was Asthma Control Questionnaire ( ACQ ) score .
METHODS	Mean changes in ACQ scores from baseline were compared between groups at 3 and 6 months to evaluate intervention efficacy .
RESULTS	The ACQ score in the intervention group ( n = 29 ) decreased by a mean SD of 0.46 1.05 at 3 months and 0.89 0.98 at 6 months .
RESULTS	The control group ( n = 29 ) had a mean decrease of 0.15 0.63 at 3 months and 0.18 0.73 at 6 months .
RESULTS	The difference between groups , adjusting for baseline , was -0.22 ( 95 % CI , -0.54 to 0.10 ) at 3 months and -0.60 ( 95 % CI , -0.85 to -0.36 ) at 6 months .
RESULTS	The difference at 6 months was statistically significant ( P < .001 ) and clinically significant ( > 0.5 ) .
RESULTS	No asthma-related oral corticosteroid use , hospital admissions , emergency visits , or days off from work were reported during the trial .
CONCLUSIONS	A multidisciplinary model of care for asthma management involving education and regular monitoring could potentially improve maternal asthma outcomes and be widely implemented in clinical practice .
BACKGROUND	Australian and New Zealand Clinical Trials Registry ; No. : ACTRN12612000681853 ; URL : www.anzctr.org.au .

###24856571
BACKGROUND	Anxiety disorders are among the most prevalent mental disorders and are usually treated with medication and/or psychotherapy .
BACKGROUND	When anxiety disorders are accompanied with comorbid depression , this further complicates the treatment process .
BACKGROUND	Medication compliance is a common problem due to adverse side effects and new and effective treatments that have minimal side effects are needed for the treatment of anxiety and depression .
BACKGROUND	This study used a randomized , double-blind , sham controlled design to examine the effectiveness of CES as a treatment for anxiety disorders and comorbid depression in a primary care setting .
BACKGROUND	The study was registered at clinicaltrials.gov , NCT01533415 .
METHODS	One hundred and fifteen participants , age 18 years and over , with a primary diagnosis of an anxiety disorder were enrolled from February 2012 to December 2012 The Hamilton Rating Scale for Anxiety ( HAM-A ) and the Hamilton Depression Rating Scale17 ( HAM-D17 ) were used for baseline and outcome measures at weeks one , three , and five .
METHODS	Response to treatment was defined as a reduction of 50 % or more on these measures .
RESULTS	Analysis of covariance revealed a significant difference between the active CES group and the sham CES group on anxiety ( p = 0.001 , d = 0.94 ) and on depression ( p = 0.001 , d = 0.78 ) from baseline to endpoint of study in favor of the active CES group .
CONCLUSIONS	CES significantly decreases anxiety and comorbid depression .
CONCLUSIONS	Subjects reported no adverse events during the study .

###25364081
OBJECTIVE	Obstructive sleep apnea ( OSA ) has been associated with hypertension , which is one of the intermediary mechanisms leading to increased cardiovascular morbidity .
OBJECTIVE	This study aimed at evaluating the effects of a combination of continuous positive airway pressure ( CPAP ) and telemedicine support on blood pressure ( BP ) reduction in high cardiovascular risk OSA patients .
METHODS	A multi-center randomized controlled trial that compared standard CPAP care and CPAP care and a telemedicine intervention .
METHODS	Sleep clinics in France .
METHODS	107 adult ( 18-65 years old ) OSA patients ( AHI > 15 events/h ) with a high cardiovascular risk ( cardiovascular SCORE > 5 % or secondary prevention ) .
METHODS	Patients were randomized to either standard care CPAP ( n = 53 ) or CPAP and telemedicine ( n = 54 ) .
METHODS	Patients assigned to telemedicine were equipped with a smartphone for uploading BP measurements , CPAP adherence , sleepiness , and quality of life data ; in return , they received pictograms containing health-related messages .
METHODS	The main outcome was home self-measured BP and secondary outcomes were cardiovascular risk evolution , objective physical activity , CPAP adherence , sleepiness and quality of life .
RESULTS	Self-measured BP did not improve in either group ( telemedicine or standard care ) .
RESULTS	Patients in primary prevention showed greater BP reduction with CPAP treatment than those in secondary prevention .
CONCLUSIONS	CPAP treatment supported by telemedicine alone did not improve blood pressure and cardiovascular risk in high cardiovascular risk OSA patients .
CONCLUSIONS	This study emphasizes the need for diet and physical activity training programs in addition to CPAP when aiming at decreasing cardiometabolic risk factors in these patients .
BACKGROUND	ClinicalTrials.gov identifier : NCT01226641 .

###25431323
BACKGROUND	To provide patient-centred holistic care , doctors must possess good interpersonal and empathic skills .
BACKGROUND	Medical schools traditionally adopt a skills-based approach to such training but creative engagement with the arts has also been effective .
BACKGROUND	A novel arts-based approach may help medical students develop empathic understanding of patients and thus contribute to medical students ' transformative process into compassionate doctors .
BACKGROUND	This study aimed to evaluate the impact of an arts-making workshop on medical student empathy .
METHODS	This was a mixed-method quantitative-qualitative study .
METHODS	In the 2011-12 academic year , all 161 third year medical students at the University of Hong Kong were randomly allocated into either an arts-making workshop or a problem-solving workshop during the Family Medicine clerkship according to a centrally-set timetable .
METHODS	Students in the arts-making workshop wrote a poem , created artwork and completed a reflective essay while students in the conventional workshop problem-solved clinical cases and wrote a case commentary .
METHODS	All students who agreed to participate in the study completed a measure of empathy for medical students , the Jefferson Scale of Empathy ( JSE ) ( student version ) , at the start and end of the clerkship .
METHODS	Quantitative data analysis : Paired t-test and repeated measures ANOVA was used to compare the change within and between groups respectively .
METHODS	Qualitative data analysis : Two researchers independently chose representational narratives based on criteria adapted from art therapy .
METHODS	The final 20 works were agreed upon by consensus and thematically analysed using a grounded theory approach .
RESULTS	The level of empathy declined in both groups over time , but with no statistically significant differences between groups .
RESULTS	For JSE items relating to emotional influence on medical decision making , participants in the arts-making workshop changed more than those in the problem-solving workshop .
RESULTS	From the qualitative data , students perceived benefits in arts-making , and gained understanding in relation to self , patients , pain and suffering , and the role of the doctor .
CONCLUSIONS	Though quantitative findings showed little difference in empathy between groups , arts-making workshop participants gained empathic understanding in four different thematic areas .
CONCLUSIONS	This workshop also seemed to promote greater self-awareness which may help medical students recognize the potential for emotions to sway judgment .
CONCLUSIONS	Future art workshops should focus on emotional awareness and regulation .

###24299915
OBJECTIVE	Resistant hypertension ( res-HTN ) is a challenging problem , but little is known of res-HTN in patients with coronary artery disease ( CAD ) .
OBJECTIVE	In this post-hoc INternational VErapamil SR-Trandolapril STudy ( INVEST ) analysis , we assessed prevalence , predictors , and impact on outcomes of res-HTN in CAD patients with hypertension .
METHODS	Participants ( n = 17190 ) were divided into three groups according to achieved blood pressure ( BP ) : controlled ( BP < 140/90 mmHg on three or fewer drugs ) ; uncontrolled ( BP 40/90 mmHg on two or fewer drugs ) ; or resistant ( BP 40/90 mmHg on three drugs or any patient on at least four drugs ) .
RESULTS	The prevalence of res-HTN was 38 % : significant predictors of res-HTN included heart failure [ odds ratio ( OR ) 1.73 ] , diabetes ( OR 1.63 ) , Black race ( OR 1.50 ) , and US residence ( OR 1.50 ) .
RESULTS	Compared with controlled HTN , res-HTN had multivariate-adjusted association with higher risk of adverse outcomes { first occurrence of all-cause death , nonfatal myocardial infarction , or nonfatal stroke [ hazard ratio 1.27 , 95 % confidence interval ( CI ) 1.13-1 .43 ] , and individual outcomes of all-cause death ( hazard ratio 1.29 , 95 % CI 1.13-1 .48 ) , cardiovascular mortality ( hazard ratio 1.47 , 95 % CI 1.21-1 .78 ) , and nonfatal stroke ( hazard ratio 1.61 , 95 % CI 1.17-2 .22 ) , but not nonfatal myocardial infarction ( hazard ratio 0.98 , 95 % CI 0.72-1 .34 ) } .
RESULTS	Adverse outcomes , except nonfatal stroke , did not differ in patients with res-HTN compared to uncontrolled HTN .
CONCLUSIONS	Res-HTN is common in patients with CAD and hypertension , associated with poor prognosis , and linked with a number of conditions .
CONCLUSIONS	Emphasis should be placed on recognizing those at risk for res-HTN and future studies should examine whether more aggressive treatment of res-HTN improves outcomes .

###25532503
BACKGROUND	There has been no study on the efficacy of lafutidine for patients with reflux esophagitis in Korea .
OBJECTIVE	To evaluate the efficacy of a new-generation histamine-2 receptor antagonist , lafutidine , in comparison with famotidine in patients with reflux esophagitis .
METHODS	This was a randomized , double-blind , non-inferiority trial enrolling patients with erosive esophagitis .
METHODS	The efficacy and safety of 20 mg lafutidine ( treatment group ) were compared with those of 40 mg famotidine ( control group ) and 20 mg omeprazole ( reference group ) .
METHODS	The primary endpoint was the complete healing rates of reflux esophagitis on endoscopy after 8 weeks of treatment .
METHODS	The non-inferiority margin was assumed to be -15 % .
RESULTS	The healing rates of reflux esophagitis on endoscopy after 8 weeks of treatment were 70.14 % ( 101/144 ) in the lafutidine , 63.45 % ( 92/145 ) in the famotidine , and 85.71 % ( 126/147 ) in the omeprazole group .
RESULTS	The difference in healing rates between the lafutidine and famotidine groups was 6.69 % ( 95 % confidence interval = [ -4.14 to 17.52 ] ) .
RESULTS	In addition , lafutidine was superior to famotidine in clinical improvement ( 53.73 % vs. 39.55 % , P = 0.0200 ) .
CONCLUSIONS	Lafutidine was non-inferior to famotidine in healing of reflux esophagitis .
CONCLUSIONS	Lafutidine , however , was superior to famotidine in terms of symptom relief of reflux esophagitis .

###24473248
BACKGROUND	Upper limb ( UL ) impairment is the most common disabling deficit following a stroke .
BACKGROUND	Previous studies have suggested that transcranial direct current stimulation ( tDCS ) enhances the effect of conventional therapies .
OBJECTIVE	This pilot double-blind randomized control trial aimed to determine whether or not tDCS , combined with Wii virtual reality therapy ( VRT ) , would be superior to Wii therapy alone in improving upper limb function and quality of life in chronic stroke individuals .
METHODS	Twenty participants were randomly assigned either to an experimental group that received VRT and tDCS , or a control group that received VRT and sham tDCS .
METHODS	The therapy was delivered over 15 sessions with 13 minutes of active or sham anodal tDCS , and one hour of virtual reality therapy .
METHODS	The outcomes included were determined using the Fugl-Meyer scale , the Wolf motor function test , the modified Ashworth scale ( MAS ) , grip strength , and the stroke specific quality of life scale ( SSQOL ) .
METHODS	Minimal clinically important differences ( MCID ) were observed when assessing outcome data .
RESULTS	Both groups demonstrated gains in all evaluated areas , except for the SSQOL-UL domain .
RESULTS	Differences between groups were only observed in wrist spasticity levels in the experimental group , where more than 50 % of the participants achieved the MCID .
CONCLUSIONS	These findings support that tDCS , combined with VRT therapy , should be investigated and clarified further .

###25139884
OBJECTIVE	Insulin resistance and secretion depend on calcium homeostasis .
OBJECTIVE	Cross-sectional studies have associated elevated serum calcium levels with markers of impaired glucose metabolism .
OBJECTIVE	However , only one prospective cohort study has demonstrated an increased risk of diabetes in individuals with increased serum calcium concentrations .
OBJECTIVE	The aim of the current study was to prospectively investigate the association between albumin-adjusted serum calcium concentrations and type 2 diabetes in subjects at high cardiovascular risk .
METHODS	Prospective assessment of participants from two Spanish PREDIMED study centers where serum calcium levels were measured at baseline and yearly during follow-up .
METHODS	Multivariate-adjusted Cox regression models were fitted to assess associations between baseline and changes during follow-up in serum calcium levels and relative risk of diabetes incidence .
RESULTS	After a median follow-up of 4.78 years , 77 new cases of type 2 diabetes occurred .
RESULTS	An increase in serum calcium levels during follow-up was related to an increased risk of diabetes .
RESULTS	In comparison with individuals in the lowest tertile ( -0.78 0.29 mg/dL ) , the hazard ratio ( HR ) and 95 % CI for diabetes incidence in individuals in the higher tertile of change ( 0.52 0.13 mg/dL ) during follow-up was 3.48 ( 95 % CI 1.48-8 .17 ; P for trend = 0.01 ) .
RESULTS	When albumin-adjusted serum calcium was analyzed as a continuous variable , per 1 mg/dL increase , the HR of diabetes incidence was 2.87 ( 95 % CI 1.18-6 .96 ; P value = 0.02 ) .
RESULTS	These associations remained significant after individuals taking calcium supplements or having calcium levels out of normal range had been excluded .
CONCLUSIONS	An increase in serum calcium concentrations is associated with an increased risk of type 2 diabetes in individuals at high cardiovascular risk .

###25152506
OBJECTIVE	To assess effectiveness and feasibility of public-private collaboration in delivering influenza immunization to children .
METHODS	Four pediatric and four family medicine ( FM ) practices in Colorado with a common public health department ( PHD ) were randomized at the beginning of baseline year ( 10/2009 ) to Intervention ( joint community clinics and PHD nurses aiding in delivery at practices ) ; or control involving usual care without PHD .
METHODS	Generalized estimating equations compared changes in rates over baseline between intervention and control practices at end of 2nd intervention year ( Y2 = 5/2011 ) .
METHODS	Barriers to collaboration were examined using qualitative methods .
RESULTS	Overall , rates increased from baseline to Y2 by 9.2 % in intervention and 3.2 % in control ( p < .0001 ) , with significant increases in both pediatric and FM practices .
RESULTS	The largest increases were seen among school-aged and adolescent children ( p < .0001 for both ) , with differences for 6-month-old to 5-year-old children and for children with high-risk conditions not reaching significance .
RESULTS	Barriers to collaboration included uncertainty regarding the delivery of vaccine supplies , concerns about using up all purchased vaccine by practices , and concerns about documentation of vaccination if collaboration occurred .
CONCLUSIONS	In spite of barriers , public-private collaboration resulted in significantly higher influenza immunization rates , particularly for older , healthy children who visit providers less frequently .

###25503557
BACKGROUND	The minimum alveolar concentration ( MAC ) of sevoflurane in neonates is 3.3 % , but this value has not been verified in Chinese neonates and the effect of different doses of fentanyl on MAC in neonates has not been investigated .
BACKGROUND	This study was designed to determine the ED and ED values of sevoflurane in Chinese neonates with and without fentanyl .
METHODS	Ninety-three neonates were randomly assigned to receive sevoflurane alone ( control group , n = 30 ) , 1 g/kg sevoflurane ( group fent1 , n = 29 ) , or 2 g/kg fentanyl ( group fent2 , n = 32 ) .
METHODS	Following inhalational induction and tracheal intubation , the end-tidal concentration of sevoflurane was adjusted to achieve the designated concentration , which was determined using the modified Dixon 's up-and-down method starting with 3.0 % in each group , with a 0.25 % step size .
METHODS	Success was defined as no motor response within 60 s of skin incision .
RESULTS	The MAC ( standard deviation ) values of sevoflurane were 2.91 % ( 0.27 ) in the control group , 2.53 % ( 0.31 ) in the fent1 group , and 2.34 % ( 0.33 ) in the fent2 group according to Dixon 's up-and-down method .
RESULTS	Logistic probit regression analysis revealed that the ED and ED ( 95 % CI ) of sevoflurane in neonates were 2.82 % ( 2.66-2 .98 ) and 3.39 % ( 2.89-3 .89 ) , respectively , in the control group ; 2.44 % ( 2.19-2 .68 ) and 3.30 % ( 2.51-4 .09 ) , respectively , in the fent1 group ; and 2.21 % ( 1.97-2 .45 ) and 3.11 % ( 2.35-3 .88 ) , respectively , in the fent2 group .
CONCLUSIONS	The MAC value of sevoflurane in Chinese neonates was lower than previously reported and was reduced by the addition of fentanyl .

###26241250
OBJECTIVE	To compare intrauterine device ( IUD ) use at 6 months postpartum among women who underwent intracesarean delivery ( during cesarean delivery ) IUD placement compared with women who planned for interval IUD placement 6 or more weeks postpartum .
METHODS	In this nonblinded randomized trial , women who were undergoing a cesarean delivery and desired an IUD were randomized to intracesarean delivery or interval IUD placement .
METHODS	The primary outcome was IUD use at 6 months postpartum .
METHODS	A sample size of 112 ( 56 in each group ) was planned to detect a 15 % difference in IUD use at 6 months postpartum between groups .
RESULTS	From March 2012 to June 2014 , 172 women were screened and 112 women were randomized into the trial .
RESULTS	Baseline characteristics were similar between groups .
RESULTS	Data regarding IUD use at 6 months postpartum were available for 98 women , 48 and 50 women in the intracesarean delivery and interval groups , respectively .
RESULTS	A larger proportion of the women in the intracesarean delivery group were using an IUD at 6 months postpartum ( 40/48 [ 83 % ] ) compared with those in the interval group ( 32/50 [ 64 % ] , relative risk 1.3 , 95 % confidence interval 1.02-1 .66 ) .
RESULTS	Among the 56 women randomized to interval IUD insertion , 22 ( 39 % ) of them never received an IUD ; 14 ( 25 % ) never returned for IUD placement , five ( 9 % ) women declined an IUD , and three ( 5 % ) had a failed IUD placement .
CONCLUSIONS	Intrauterine device placement at the time of cesarean delivery leads to a higher proportion of IUD use at 6 months postpartum when compared with interval IUD placement .
METHODS	I.

###24425122
OBJECTIVE	Hemicraniectomy and Durotomy Upon Deterioration From Infarction-Related Swelling Trial ( HeADDFIRST ) was a randomized pilot study to obtain information necessary to design a Phase III trial to evaluate the benefit of surgical decompression for brain swelling from large supratentorial cerebral hemispheric infarction .
METHODS	All patients with stroke were screened for eligibility ( age 18-75 years , National Institutes of Health Stroke Scale18 with Item 1a < 2 [ responsive to minor stimulation ] , and CT demonstrating unilateral , complete middle cerebral artery territory infarction by specific imaging criteria ) .
METHODS	All enrolled patients were treated using a standardized medical treatment protocol .
METHODS	Those with both4 mm of pineal shift and deterioration in level of arousal or 7.5 mm of anteroseptal shift within 96 hours of stroke onset were randomized to continued medical treatment only or medical treatment plus surgery .
METHODS	Death at 21 days was the primary outcome measure .
RESULTS	Among 4909 screened patients , only 66 ( 1.3 % ) patients were eligible for HeADDFIRST .
RESULTS	Forty patients were enrolled , and 26 patients developed the requisite brain swelling for randomization .
RESULTS	All who failed to meet randomization criteria were alive at 21 days .
RESULTS	Mortality at 21 and 180 days was 40 % ( 4/10 ) in the medical treatment only and 21 % ( 3/14 ) and 36 % ( 5/14 ) in the medical treatment plus surgery arms , respectively .
CONCLUSIONS	HeADDFIRST randomization criteria effectively distinguished low from high risk of death from large supratentorial cerebral hemispheric infarction .
CONCLUSIONS	Lower mortality in the medical treatment only group than in other published trials suggests a possible benefit to standardizing medical management .
CONCLUSIONS	These results can inform the interpretation of recently completed European trials concerning patient selection and medical management .
BACKGROUND	This trial was not registered because enrollment began before July 1 , 2005 .

###24467692
OBJECTIVE	To compare clinical outcome and callus biomechanical properties of a novel angle stable interlocking nail ( AS-ILN ) and a 6 mm bolted standard ILN ( ILN6b ) in a canine tibial fracture model .
METHODS	Experimental in vivo study .
METHODS	Purpose-bred hounds ( n = 11 ) .
METHODS	A 5 mm mid-diaphyseal tibial ostectomy was stabilized with an AS-ILN ( n = 6 ) or an ILN6b ( n = 5 ) .
METHODS	Orthopedic examinations and radiographs were performed every other week until clinical union ( 18 weeks ) .
METHODS	Paired tibiae were tested in torsion until failure .
METHODS	Callus torsional strength and toughness were statistically compared and failure mode described .
METHODS	Total and cortical callus volumes were computed and statistically compared from CT slices of the original ostectomy gap .
METHODS	Statistical significance was set at P < .05 RESULTS : From 4 to 8 weeks , lameness was less pronounced in AS-ILN than ILN6b dogs ( P < .05 ) .
METHODS	Clinical union was reached in all AS-ILN dogs by 10 weeks and in 3/5 ILN6b dogs at 18 weeks .
METHODS	Callus mechanical properties were significantly greater in AS-ILN than ILN6b specimens by 77 % ( failure torque ) and 166 % ( toughness ) .
METHODS	Failure occurred by acute spiral ( control and AS-ILN ) or progressive transverse fractures ( ILN6b ) .
METHODS	Cortical callus volume was 111 % greater in AS-ILN than ILN6b specimens ( P < .05 ) .
CONCLUSIONS	Earlier functional recovery , callus strength and remodeling suggest that the AS-ILN provides a postoperative biomechanical environment more conducive to bone healing than a comparable standard ILN .

###25819853
BACKGROUND	Guidelines recommendations regarding anticoagulant therapy after percutaneous coronary intervention ( PCI ) among patients with atrial fibrillation ( AF ) rely on retrospective , nonrandomized observational data .
BACKGROUND	Currently , patients are treated with triple-therapy ( dual antiplatelet therapy [ DAPT ] + oral anticoagulation therapy ) , but neither the duration of DAPT nor the level of anticoagulation has been studied in a randomized fashion .
BACKGROUND	Recent studies also suggest dual pathway therapy with clopidogrel plus oral anticoagulation therapy may be superior , and other studies suggest that novel oral anticoagulants such as rivaroxaban may further improve patient outcomes .
METHODS	PIONEER AF-PCI ( ClinicalTrials.gov NCT01830543 ) is an exploratory , open-label , randomized , multicenter clinical study assessing the safety of 2 rivaroxaban treatment strategies and 1 vitamin K antagonist ( VKA ) treatment strategy in subjects who have paroxysmal , persistent , or permanent nonvalvular AF and have undergone PCI with stent placement .
METHODS	Approximately 2,100 subjects will be randomized in a 1:1:1 ratio to receive either rivaroxaban 15 mg once daily plus clopidogrel 75 mg daily for 12 months ( a WOEST trial-like strategy ) , or rivaroxaban 2.5 mg twice daily ( with stratification to a prespecified duration of DAPT 1 , 6 , or 12 months , an ATLAS trial-like strategy ) , or dose-adjusted VKA once daily ( with stratification to a prespecified duration of DAPT 1 , 6 , or 12 months , traditional triple therapy ) .
METHODS	All patients will be followed up for 12 months for the primary composite end point of Thrombolysis in Myocardial Infarction major bleeding , bleeding requiring medical attention , and minor bleeding ( collectively , clinically significant bleeding ) .
CONCLUSIONS	The PIONEER AF-PCI study is the first randomized comparison of VKA vs novel oral anticoagulant therapy in patients with NVAF receiving antiplatelet therapy after PCI to assess the relative risks of bleeding complications .

###25437877
BACKGROUND	Roux-en-Y gastric bypass ( RYGB ) surgery causes profound weight loss and improves insulin sensitivity ( S ( I ) ) in obese patients .
BACKGROUND	Regular exercise can also improve S ( I ) in obese individuals ; however , it is unknown whether exercise and RYGB surgery-induced weight loss would additively improve S ( I ) and other cardiometabolic factors .
METHODS	We conducted a single-blind , prospective , randomized trial with 128 men and women who recently underwent RYGB surgery ( within 1-3 months ) .
METHODS	Participants were randomized to either a 6-month semi-supervised moderate exercise protocol ( EX , n = 66 ) or a health education control ( CON ; n = 62 ) intervention .
METHODS	Main outcomes measured included S ( I ) and glucose effectiveness ( S ( G ) ) , which were determined from an intravenous glucose tolerance test and minimal modeling .
METHODS	Secondary outcomes measured were cardiorespiratory fitness ( VO2 peak ) and body composition .
METHODS	Data were analyzed using an intention-to-treat ( ITT ) and per-protocol ( PP ) approach to assess the efficacy of the exercise intervention ( > 120 min of exercise/week ) .
RESULTS	119 ( 93 % ) participants completed the interventions , 95 % for CON and 91 % for EX .
RESULTS	There was a significant decrease in body weight and fat mass for both groups ( P < 0.001 for time effect ) .
RESULTS	S ( I ) improved in both groups following the intervention ( ITT : CON vs. EX ; +1.64 vs. +2.24 min/U/ml , P = 0.18 for , P < 0.001 for time effect ) .
RESULTS	A PP analysis revealed that exercise produced an additive S ( I ) improvement ( PP : CON vs. EX ; +1.57 vs. +2.69 min/U/ml , P = 0.019 ) above that of surgery .
RESULTS	Exercise also improved S ( G ) ( ITT : CON vs. EX ; +0.0023 vs. +0.0063 min , P = 0.009 ) compared with the CON group .
RESULTS	Exercise improved cardiorespiratory fitness ( VO2 peak ) compared with the CON group .
CONCLUSIONS	Moderate exercise following RYGB surgery provides additional improvements in S ( I ) , S ( G ) , and cardiorespiratory fitness compared with a sedentary lifestyle during similar weight loss .
BACKGROUND	clinicaltrials.gov identifier : NCT00692367 .
BACKGROUND	This study was funded by the NIH/National Institute of Diabetes and Digestive and Kidney Diseases ( R01 DK078192 ) and an NIH/National Center for Research Resources/Clinical and Translational Science Award ( UL1 RR024153 ) .

###25081694
BACKGROUND	Breast cancer is the most common female malignancy in the world .
BACKGROUND	Beta glucan can be a hematopoietic and an immune modulator agent in cancer patients .
BACKGROUND	The aim of this trial was to determine the effect of beta glucan on white blood cell counts and serum levels of IL-4 and IL-12 in women with breast cancer undergoing chemotherapy .
METHODS	This randomized double-blind placebo-controlled clinical trial was conducted on 30 women with breast carcinoma aged 28-65 years .
METHODS	The eligible participants were randomly assigned to intervention ( n = 15 ) or placebo ( n = 15 ) groups using a block randomization procedure with matching based on age , course of chemotherapy and menopause status .
METHODS	Patients in the intervention group received two 10-mg capsules of soluble 1-3 , 1-6 , D-beta glucan daily and the control group receiving placebo during 21 days , the interval between two courses of chemotherapy .
METHODS	White blood cells , neuthrophil , lymphocyte and monocyte counts as well as serum levels of IL-4 and IL-12 were measured at baseline and at the end of the study as primary outcomes of the study .
RESULTS	In both groups white blood cell counts decreased after 21 days of the intervention , however in the beta glucan group , WBC was less decreased non significantly than the placebo group .
RESULTS	At the end of the study , the change in the serum level of IL-4 in the beta glucan group in comparison with the placebo group was statistically significant ( p = 0.001 ) .
RESULTS	The serum level of IL-12 in the beta glucan group statistically increased ( p = 0.03 ) and comparison between two groups at the end of the study was significant after adjusting for baseline values and covariates ( p = 0.007 ) .
CONCLUSIONS	The findings suggest that beta glucan can be useful as a complementary or adjuvant therapy and immunomodulary agent in breast cancer patients in combination with cancer therapies , but further studies are needed for confirmation .

###24347034
OBJECTIVE	Ropivacaine-induced vasoconstriction may affect the early absorption speed of ropivacaine ; however , the effects of dose on pharmacokinetics following transversus abdominis plane ( TAP ) block have not been studied .
OBJECTIVE	In this study , we have examined plasma ropivacaine concentrations following TAP block with various ropivacaine concentrations ( 0.25 , 0.5 , and 0.75 % ) .
METHODS	With the approval of our University ethics committee and informed consent , 39 adult patients undergoing open retropubic prostatectomy were enrolled .
METHODS	Patients were randomly assigned to three groups ( n = 13 each ) receiving TAP block with 20 ml ( 10 ml each side ) of different concentrations of ropivacaine .
METHODS	To determine plasma concentrations , blood samples were drawn before and 15 , 30 , 45 , 60 , 90 , 120 , and 180 min after completion of bilateral TAP blocks .
METHODS	Plasma ropivacaine concentrations were analyzed by gas chromatography with mass spectrometry .
RESULTS	We found that the peak plasma concentrations ( C ( max ) ) increased dose dependently ( 0.41 0.14 , 0.89 0.55 , and 1.56 0.50 g/ml ) , but the times to C ( max ) ( 23.0 15.8 , 23.1 14.5 , and 20.8 11.5 min ) were not different between 0.25 , 0.5 , and 0.75 % ropivacaine doses , respectively .
RESULTS	Terminal elimination half-life ( t ( 1/2 ) ) , total body clearance ( CL ) , and distribution volume ( V ( d ) ) were also not different among the three groups .
CONCLUSIONS	Ropivacaine concentration did not alter pharmacokinetic profile following TAP blocks .

###25884195
BACKGROUND	There are a high number of adolescents who are at risk of developing an eating disorder .
BACKGROUND	There is , therefore , a strong need to implement prevention programs aimed at reducing the incidence of eating disorders at this critical age .
BACKGROUND	Among other factors , successful prevention programs have been shown to be interactive , carried out by professionals , focused on educational as well as psychosocial elements and have taken risk factors as well as resources into account .
BACKGROUND	The objective of this study protocol is to present the design of a new prevention program for eating disorders in schools .
METHODS	The gender-adapted prevention program extends over six school hours .
METHODS	It contains interactive and educational elements about eating disorders and their treatment .
METHODS	Participants pass through different exercises and reflect on the influences of the media , self-esteem , body perception and individual resources .
METHODS	A cluster-randomized controlled trial is chosen to evaluate the program .
METHODS	Based on an estimated effect size of d = 0.3 a total of 1848 participants are enrolled in the study .
METHODS	Eating disorder risk , internalization of Western beauty ideals , body dissatisfaction , self-concept as well as anxiety and symptoms of depression are measured before and immediately after the intervention as well as at a six-month follow-up .
METHODS	In addition , the intervention group evaluates the different components of the program .
CONCLUSIONS	The study intends to test the practicability and efficacy of an interactive , gender-adapted ED prevention program in schools .
CONCLUSIONS	Moreover , it will provide valuable information about the occurrence of eating disorder risk factors in school-aged children .
BACKGROUND	ISRCTN97989348 ; Registered 19 December 2012 .

###25015912
BACKGROUND	In chronic human immunodeficiency virus ( HIV ) infection , plasma cystatin C may be influenced by factors other than glomerular filtration rate such as inflammation .
BACKGROUND	Statins may improve cystatin C by improving glomerular function or by decreasing inflammation .
METHODS	The Stopping Atherosclerosis and Treating Unhealthy Bone With Rosuvastatin in HIV ( SATURN-HIV ) trial randomized 147 patients on stable antiretroviral therapy ( ART ) with low-density lipoprotein cholesterol 130 mg/dL to blinded 10 mg daily rosuvastatin or placebo .
METHODS	We analyzed relationships of baseline and 0 - to 24-week changes in plasma cystatin C concentration with measures of vascular disease , inflammation , and immune activation .
RESULTS	Median age was 46 ( interquartile range , 40-53 ) years ; 78 % were male , 68 % African American .
RESULTS	Tenofovir and protease inhibitors were used in 88 % and 49 % of subjects , respectively .
RESULTS	Baseline cystatin C was associated with higher carotid intima-media thickness and epicardial adipose tissue independent of age , sex , and race .
RESULTS	Biomarkers of endothelial activation and inflammation were associated with cystatin C in a multivariable model independent of creatinine-based estimated glomerular filtration rate ( eGFRcr ) .
RESULTS	After 24 weeks , statin use slowed mean eGFRcr decline ( 1.61 vs -3.08 mL/minute/1 .73 m ( 2 ) for statin vs placebo ; P = .033 ) and decreased mean cystatin C ( -0.034 mg/L vs 0.010 mg/L ; P = .008 ) .
RESULTS	Within the statin group , changes in cystatin C correlated with changes in endothelial activation , inflammation , and T-cell activation .
CONCLUSIONS	Rosuvastatin 10 mg daily reduces plasma cystatin C and slows kidney function decline in HIV-infected patients on ART .
CONCLUSIONS	Reductions in cystatin C with statin therapy correlate with reductions in inflammatory biomarkers .
CONCLUSIONS	Relationships between cystatin C , kidney function , and cardiovascular risk in HIV may be mediated in part by inflammation .
CONCLUSIONS	Clinical Trials Registration .
CONCLUSIONS	NCT01218802 .

###24845394
OBJECTIVE	The steady-state pharmacokinetics of two doses of a transdermal testosterone cream ( TTC ) was investigated after daily application for 21 days .
METHODS	This was a two-way cross-over study conducted for 6 weeks .
METHODS	Seven healthy postmenopausal women ( mean age , 59.3 y ) were randomly allocated to 5 or 10 mg of TTC applied daily to the upper arm .
METHODS	Serum total testosterone ( TT ) , free testosterone ( fT ) , sex hormone-binding globulin , and metabolite concentrations were measured .
METHODS	Baseline-corrected and uncorrected serum TT and fT pharmacokinetic parameters ( AUC0-24 , C avg , Cmax , and Tmax ) were calculated using a standard model-independent approach .
RESULTS	After the single-dose application of 5 mg of TTC on day 22 , the median uncorrected TT C avg was found to be 0.54 ng/mL ( range , 0.43-1 .31 ) , and the median uncorrected fT C avg was found to be 4.14 pg/mL ( range , 2.41-9 .72 ) .
RESULTS	Doubling of the dose only resulted in a 30 % increase in baseline-corrected TT C avg ( 0.52 vs 0.69 ng/mL for 5 and 10 mg , respectively ) and a 31 % increase in baseline-corrected fT C avg ( 4.75 vs 6.24 pg/mL for 5 and 10 mg , respectively ) .
RESULTS	Neither dose resulted in any meaningful variation in dihydrotestosterone , estrone , estradiol , or sex hormone-binding globulin across the postdose sampling period .
CONCLUSIONS	The 5-mg TTC dose restores TT and fT levels to levels above and within the reference range , respectively , for premenopausal women .

###24890124
OBJECTIVE	Transbronchial lung biopsy ( TBLB ) is required for evaluation in selected patients with interstitial lung disease ( ILD ) .
OBJECTIVE	The diagnostic yield of histopathologic assessment is variable and is influenced by factors such as the size of samples and the presence of crush artefacts left by conventional biopsy forceps .
OBJECTIVE	We compared the diagnostic yield and safety of TBLB with cryoprobe sampling versus conventional forceps sampling .
METHODS	This randomized clinical trial analysed data for 77 patients undergoing TBLB for evaluation of ILD ; patients were assigned to either a conventional-forceps group or a cryoprobe group .
METHODS	Two pathologists assessed the tissue samples and agreed on histopathologic diagnoses .
METHODS	We also compared the duration of procedures , complications and sample-quality variables .
RESULTS	The most frequent diagnosis observed in the cryoprobe group was non-specific interstitial pneumonia .
RESULTS	Histopathologic diagnoses were identified in more cases in the cryoprobe group ( 74.4 % ) than in the conventional-forceps group ( 34.1 % ) ( P < 0.001 ) , and the diagnostic yield was higher in the cryoprobe group ( 51.3 % vs 29.1 % in the conventional forceps group ; P = 0.038 ) .
RESULTS	A larger mean area of tissue was harvested by cryoprobe ( 14.7 11 mm ( 2 ) ) than by conventional forceps ( 3.3 4.1 mm ( 2 ) ) ( P < 0.001 ) .
RESULTS	More grade 2 bleeding ( not statistically significant ) occurred in the cryoprobe group ( 56.4 % ) than in the conventional-forceps group ( 34.2 % ) .
RESULTS	No differences in other complications were observed .
CONCLUSIONS	TBLB by cryoprobe is safe and potentially useful in the diagnosis of ILD .
CONCLUSIONS	Larger multisite randomized trials are required to confirm the potential benefits of this procedure .
CONCLUSIONS	Clinical trial registration at ClinicalTrials.gov : NCT01064609 .

###24690470
BACKGROUND	Armed conflicts are associated with a wide range of impacts on the mental health of children and adolescents .
BACKGROUND	We evaluated the effectiveness of a school-based intervention aimed at reducing symptoms of posttraumatic stress disorder , depression , and anxiety ( treatment aim ) ; and improving a sense of hope and functioning ( preventive aim ) .
METHODS	We conducted a cluster randomized trial with 329 children in war-affected Burundi ( aged 8 to 17 ( mean 12.29 years , standard deviation 1.61 ) ; 48 % girls ) .
METHODS	One group of children ( n = 153 ) participated in a 15-session school-based intervention implemented by para-professionals , and the remaining 176 children formed a waitlist control condition .
METHODS	Outcomes were measured before , one week after , and three months after the intervention .
RESULTS	No main effects of the intervention were identified .
RESULTS	However , longitudinal growth curve analyses showed six favorable and two unfavorable differences in trajectories between study conditions in interaction with several moderators .
RESULTS	Children in the intervention condition living in larger households showed decreases on depressive symptoms and function impairment , and those living with both parents showed decreases on posttraumatic stress disorder and depressive symptoms .
RESULTS	The groups of children in the waitlist condition showed increases in depressive symptoms .
RESULTS	In addition , younger children and those with low levels of exposure to traumatic events in the intervention condition showed improvements on hope .
RESULTS	Children in the waitlist condition who lived on their original or newly bought land showed improvements in hope and function impairment , whereas children in the intervention condition showed deterioration on these outcomes .
CONCLUSIONS	Given inconsistent effects across studies , findings do not support this school-based intervention as a treatment for posttraumatic stress disorder and depressive symptoms in conflict-affected children .
CONCLUSIONS	The intervention appears to have more consistent preventive benefits , but these effects are contingent upon individual ( for example , age , gender ) and contextual ( for example , family functioning , state of conflict , displacement ) variables .
CONCLUSIONS	Results suggest the potential benefit of school-based preventive interventions particularly in post-conflict settings .
BACKGROUND	The study was registered as ISRCTN42284825 .

###24860124
OBJECTIVE	Although fresh frozen plasma ( FFP ) is one of the most commonly used hemostatic agents in clinical specialties today , there is little evidence available supporting its administration .
OBJECTIVE	Our present study observed the effects of a priming strategy without FFP during cardiopulmonary bypass ( CPB ) on postoperative coagulation and clinical recovery in pediatric patients , aiming to supply new evidence for evidence-based use of FFP .
METHODS	Eighty pediatric patients with congenital heart disease undergoing cardiac surgery with CPB were randomized to receive either 10-20 ml/kg 4 % succinylated gelatin ( Gelofusine , GEL group , n = 40 ) or 1-2 units FFP ( FFP group , n = 40 ) in the pump prime .
METHODS	Rapid-thromboelastography ( r-TEG ) and functional fibrinogen level were measured before skin incision and 15 minutes after heparin reversal .
METHODS	We recorded the volume of chest tube drainage , transfusion requirements and the dosage of pharmacological agents .
METHODS	The ventilation time , ICU length of stay and hospitalization time after surgery were also collected .
RESULTS	After heparin neutralization , there were significantly elevated levels of fibrinogen in the FFP group , which were manifested by r-TEG parameters MAf and FLEV .
RESULTS	No significant differences were observed between the two groups in postoperative bleeding , transfusion requirements and the usage of pharmacological agents .
RESULTS	Recovery time was also comparable between the two groups .
CONCLUSIONS	In conclusion , prophylactic use of FFP in the priming solution does not provide clinical benefits as presumed .
CONCLUSIONS	Artificial colloids , such as Gelofusine , can be used safely and effectively as a substitute for FFP in the pump prime .
CONCLUSIONS	TEG is an effective assessment tool to evaluate postoperative coagulation function in pediatric patients .

###24369097
BACKGROUND	The prevalence of heart failure ( HF ) is rising in industrialized and developing countries .
BACKGROUND	Though invasive coronary angiography ( ICA ) remains the gold standard for anatomical assessment of coronary artery disease in HF patients , alternatives are being sought .
BACKGROUND	Computed tomographic coronary angiography ( CTA ) has emerged as an accurate non-invasive diagnostic tool for coronary artery disease ( CAD ) and has been demonstrated to have prognostic value .
BACKGROUND	Whether or not CTA can be used in HF patients is unknown .
BACKGROUND	Acknowledging the aging population , the growing prevalence of HF and the increasing financial burden of healthcare , we need to identify non-invasive diagnostic tests that are available , safe , accurate and cost-effective .
METHODS	The proposed study aims to provide insight into the efficacy of CTA in HF patients .
METHODS	A multicenter randomized controlled trial will enroll 250 HF patients requiring coronary anatomical definition .
METHODS	Enrolled patients will be randomized to either CTA or ICA ( n = 125 per group ) as the first test to define coronary anatomy .
METHODS	The primary outcomes will be collected to determine downstream resource utilization .
METHODS	Secondary outcomes will include the composite clinical events and major adverse cardiac events .
METHODS	In addition , the accuracy of CTA for detecting coronary anatomy and obstruction will be assessed in patients who subsequently undergo both CTA and ICA .
METHODS	It is expected that CTA will be a more cost-effective strategy for diagnosis : yielding similar outcomes with fewer procedural risks and improved resource utilization .
BACKGROUND	ClinicalTrials.gov , NCT01283659 .
BACKGROUND	Team grant #CIF 99470 .

###25288600
OBJECTIVE	People with multiple and persistent mental and physical health problems have high rates of transition failures when transferring from a hospital level of care to home .
OBJECTIVE	The transitional care model ( TCM ) is evidence-based and demonstrated to improve posthospital outcomes for elderly with physical health conditions , but it has not been studied in the population with serious mental illness .
METHODS	Using a randomized controlled design , 40 inpatients from two general hospital psychiatric units were recruited and randomly assigned to an intervention group ( n = 20 ) that received the TCM intervention that was delivered by a psychiatric nurse practitioner for 90 days posthospitalization , or a control group ( n = 20 ) that received usual care .
METHODS	Outcomes were as follows : service utilization , health-related quality of life , and continuity of care .
RESULTS	The intervention group showed higher medical and psychiatric rehospitalization than the control group ( p = .054 ) .
RESULTS	Emergency room use was lower for intervention group but not statistically significant .
RESULTS	Continuity of care with primary care appointments were significantly higher for the intervention group ( p = .023 ) .
RESULTS	The intervention group 's general health improved but was not statistically significant compared with controls .
CONCLUSIONS	A transitional care intervention is recommended ; however , the model needs to be modified from a single nurse to a multidisciplinary team with expertise from a psychiatric nurse practitioner , a social worker , and a peer support specialist .
CONCLUSIONS	A team approach can best manage the complex physical/mental health conditions and complicated social needs of the population with serious mental illness .

###24710800
OBJECTIVE	To compare the operative data and early postoperative outcomes of total laparoscopic hysterectomy ( TLH ) , laparoscopically assisted vaginal hysterectomy ( LAVH ) and vaginal hysterectomy ( VH ) .
METHODS	One hundred and eight women requiring hysterectomy for enlarged myomatous uterus were randomly allocated into three treatment arms : TLH ( n = 36 ) ; LAVH ( n = 36 ) ; VH ( n = 36 ) .
METHODS	Randomization procedure was based on a computer-generated list .
METHODS	The primary outcome was the discharge time comparison .
METHODS	The secondary outcomes were operating time , blood loss , paralytic ileus time , intraoperative complications , postoperative pain , and early postoperative complications .
RESULTS	The mean discharge time was shorter after VH than after LAVH and TLH ( P = 0.001 ) .
RESULTS	Operating time significantly influenced the discharge time , considered as a dependent variable in general linear model analysis ( P = 0.006 ) .
RESULTS	In contrast , blood loss did not influence the discharge time ( P = 0.55 ) .
RESULTS	The mean operating time was significantly shorter in VH than in TLH and LAVH groups ( P = 0.000 ) .
RESULTS	The intraoperative blood loss was greater during LAVH than during TLH and VH ( P = 0.000 ) .
RESULTS	Paralytic ileus time was shorter after VH than after TLH and LAVH ( P = 0.000 ) .
RESULTS	No intraoperative complications or conversion to laparotomy occurred .
CONCLUSIONS	VH was the faster operative technique with smaller blood loss and shorter discharge time compared with the others two techniques .
CONCLUSIONS	So , VH should be considered the preferred approach in patients with enlarged myomatous uteri .
CONCLUSIONS	When VH is not feasible or salpingo-oophorectomy is required , LAVH or TLH should be considered as valid alternatives .
CONCLUSIONS	It is necessary to continue prospective comparative studies between the various surgical options to identify the best approach for hysterectomy in each single woman .

###24559619
OBJECTIVE	Hirsutism has negative impact on adolescent psychosocial development for both cosmetic and endocrine reasons .
OBJECTIVE	This study evaluated the effectiveness of a new intermittent , low-dose finasteride regimen consisting of 2.5 mg of drug given every 3 days ( 1 day of treatment , 2 days of drug withdrawal ) for 6 months in girls with hirsutism by polycystic ovarian syndrome ( PCOS ) or idiopathic hirsutism ( IH ) .
METHODS	Twenty-eight girls ( 15-19 y old ) with hirsutism were randomly assigned to 2 treatment groups and treated for 6 months .
METHODS	Fourteen patients ( 7 with IH , 7 with PCOS ) received finasteride ; fourteen patients ( 7 with IH , 7 with PCOS ) received placebo .
METHODS	Hirsutism score ( HS ) , clinical , and hormonal effects were compared between the 2 groups .
RESULTS	In patients treated with finasteride , the HS value at 6 months was 52.9 % lower than that observed at baseline in girls with IH , and 52.8 % lower in girls with PCOS ( P < .0001 for both ) .
RESULTS	Similarly , the 3-17 - androstenediol glucuronide serum levels were decreased by 34.8 % in patients with IH , and by 47.5 % in patients with PCOS ( P < .0001 , respectively ) .
RESULTS	Finasteride treatment was well tolerated and did not alter values of BMI , serum levels of sexual hormones , metabolic parameters related to liver and kidney function as well as glycemic and lipidic asset .
CONCLUSIONS	A low-dose of finasteride , given every 3 days , reduces the HS in young patients affected by PCOS or IH .
CONCLUSIONS	Compared with conventional continuous finasteride administration , the intermittent low-dose regimen has similar efficacy with the advantage to be safer and less expensive .

###25841624
OBJECTIVE	Relevant clinical data are needed given the increasing national interest in charged particle radiation therapy ( CPT ) programs .
OBJECTIVE	Here we report long-term outcomes from the only randomized , stratified trial comparing CPT with iodine-125 plaque therapy for choroidal and ciliary body melanoma .
METHODS	From 1985 to 1991 , 184 patients met eligibility criteria and were randomized to receive particle ( 86 patients ) or plaque therapy ( 98 patients ) .
METHODS	Patients were stratified by tumor diameter , thickness , distance to disc/fovea , anterior extension , and visual acuity .
METHODS	Tumors close to the optic disc were included .
METHODS	Local tumor control , as well as eye preservation , metastases due to melanoma , and survival were evaluated .
RESULTS	Median follow-up times for particle and plaque arm patients were 14.6 years and 12.3 years , respectively ( P = .22 ) , and for those alive at last follow-up , 18.5 and 16.5 years , respectively ( P = .81 ) .
RESULTS	Local control ( LC ) for particle versus plaque treatment was 100 % versus 84 % at 5 years , and 98 % versus 79 % at 12 years , respectively ( log rank : P = .0006 ) .
RESULTS	If patients with tumors close to the disc ( < 2 mm ) were excluded , CPT still resulted in significantly improved LC : 100 % versus 90 % at 5 years and 98 % versus 86 % at 12 years , respectively ( log rank : P = .048 ) .
RESULTS	Enucleation rate was lower after CPT : 11 % versus 22 % at 5 years and 17 % versus 37 % at 12 years , respectively ( log rank : P = .01 ) .
RESULTS	Using Cox regression model , likelihood ratio test , treatment was the most important predictor of LC ( P = .0002 ) and eye preservation ( P = .01 ) .
RESULTS	CPT was a significant predictor of prolonged disease-free survival ( log rank : P = .001 ) .
CONCLUSIONS	Particle therapy resulted in significantly improved local control , eye preservation , and disease-free survival as confirmed by long-term outcomes from the only randomized study available to date comparing radiation modalities in choroidal and ciliary body melanoma .

###25590308
BACKGROUND	There is a need for controlled trials to guide the perioperative management of patients undergoing endoscopic sinus surgery ( ESS ) .
BACKGROUND	The authors performed a pilot multicenter trial to compare two types of saline delivery devices in this population .
METHODS	Patients were randomized to high volume saline irrigation with a squeeze bottle and low volume saline spray after ESS in patients with chronic rhinosinusitis ( CRS ) .
METHODS	Surgeons were blinded to treatment , and one-month postoperative scores for sinonasal outcomes [ Sinonasal Outcome Test-22 ( SNOT-22 ) ] scale , nasal and sinus symptom score ( NSS ) , and perioperative sinus endoscopy ( POSE ) scale were compared with preoperative scores .
RESULTS	Nine centers provided data for 86 patients .
RESULTS	All three outcomes measures improved significantly for both groups .
RESULTS	Saline spray : SNOT-22 48.8 versus .
RESULTS	23.7 , treatment effect 25.1 ( 95 % confidence interval [ CI ] , 17.9-32 .2 ) , POSE 21.1 versus .
RESULTS	8.4 , treatment effect 12.7 ( 95 % CI , 9.2-16 .1 ) , and NSS 8.2 versus 5.0 , treatment effect 3.1 ( 95 % CI , 1.4-4 .9 ) pre - and postoperatively , respectively ( all p < 0.0001 ) .
RESULTS	Squeeze bottle : SNOT-22 49.5 versus 23.6 , treatment effect 25.9 ( 95 % CI , 20.3-31 .6 ) , POSE 18.6 versus 9.2 , treatment effect 9.3 , ( 95 % CI 6.7-12 .0 ) , and NSS 9.0 versus 5.7 , treatment effect 3.3 ( 95 % CI , 2.3-4 .3 ) pre - and postoperatively , respectively ( all p < 0.0001 ) .
RESULTS	Analysis of variance did not identify a difference between the two treatment groups .
RESULTS	Subgroup analysis based on preoperative disease severity did not change the nonassociation of saline bottle with outcome measures .
RESULTS	Post hoc sample size calculation determined that 176 patients is required to detect an 8.9-point difference in SNOT-22 scores .
CONCLUSIONS	In this pilot multicenter trial examining patients with chronic rhinosinusitis undergoing ESS , both squeeze bottle and saline spray showed significant improvement in SNOT-22 , POSE , and NSS scores at one-month postoperatively .
CONCLUSIONS	Because the study was nonpowered , we can not rule out a potential difference between the two treatment groups .

###25646324
BACKGROUND	Intentional weight loss in obese older adults is a risk factor for muscle loss and sarcopenia .
OBJECTIVE	The objective was to examine the effect of a high whey protein - , leucine - , and vitamin D-enriched supplement on muscle mass preservation during intentional weight loss in obese older adults .
METHODS	We included 80 obese older adults in a double-blind randomized controlled trial .
METHODS	During a 13-wk weight loss program , all subjects followed a hypocaloric diet ( -600 kcal/d ) and performed resistance training 3/wk .
METHODS	Subjects were randomly allocated to a high whey protein - , leucine - , and vitamin D-enriched supplement including a mix of other macro - and micronutrients ( 150 kcal , 21 g protein ; 10/wk , intervention group ) or an isocaloric control .
METHODS	The primary outcome was change in appendicular muscle mass .
METHODS	The secondary outcomes were body composition , handgrip strength , and physical performance .
METHODS	Data were analyzed by using ANCOVA and mixed linear models with sex and baseline value as covariates .
RESULTS	At baseline , mean SD age was 63 5.6 y , and body mass index ( in kg/m ( 2 ) ) was 33 4.4 .
RESULTS	During the trial , protein intake was 1.11 0.28 g kg body weight ( -1 ) d ( -1 ) in the intervention group compared with 0.85 0.24 g kg body weight ( -1 ) d ( -1 ) in the control group ( P < 0.001 ) .
RESULTS	Both intervention and control groups decreased in body weight ( -3.4 3.6 kg and -2.8 2.8 kg ; both P < 0.001 ) and fat mass ( -3.2 3.1 kg and -2.5 2.4 kg ; both P < 0.001 ) , with no differences between groups .
RESULTS	The 13-wk change in appendicular muscle mass , however , was different in the intervention and control groups [ +0.4 1.2 kg and -0.5 2.1 kg , respectively ; = 0.95 kg ( 95 % CI : 0.09 , 1.81 ) ; P = 0.03 ] .
RESULTS	Muscle strength and function improved over time without significant differences between groups .
CONCLUSIONS	A high whey protein - , leucine - , and vitamin D-enriched supplement compared with isocaloric control preserves appendicular muscle mass in obese older adults during a hypocaloric diet and resistance exercise program and might therefore reduce the risk of sarcopenia .
CONCLUSIONS	This trial was registered at the Dutch Trial Register ( http://www.trialregister.nl ) as NTR2751 .

###24961363
BACKGROUND	Treatments for drug addiction and smoking in severely mentally ill ( SMI ) adults are needed .
OBJECTIVE	To investigate the effect of a contingency management ( CM ) intervention targeting psycho-stimulant on cigarette smoking .
METHODS	126 stimulant dependent SMI smokers were assigned to CM or a non-contingent control condition .
METHODS	Rates of smoking-negative ( < 3 ppm ) carbon monoxide breath-samples were compared .
RESULTS	Individuals who received CM targeting psycho-stimulants were 79 % more likely to submit a smoking-negative breath-sample relative to controls .
CONCLUSIONS	This study provides initial evidence that a behavioral treatment for drug use results in reductions in cigarette smoking in SMI adults .

###25664602
BACKGROUND	Although dipeptidyl-peptidase-4 inhibitors exert their major action via an incretin mechanism , a favorable effect of vildagliptin on lipid metabolism remains unexplained .
OBJECTIVE	The objective was to examine hepatic triglyceride levels and insulin sensitivity on vildagliptin .
METHODS	This was a 6-month , randomized , double-blind , placebo-controlled trial .
METHODS	This was an outpatient study at a university clinical research center .
METHODS	Individuals with type 2 diabetes ( n = 44 ) and glycated hemoglobin 7.6 % on stable metformin therapy were included .
METHODS	Intervention was vildagliptin 50 mg twice a day or placebo over 6 months .
METHODS	Main outcome measures were hepatic triglyceride levels and insulin sensitivity .
RESULTS	Mean fasting liver triglyceride content decreased by 27 % with vildagliptin , from 7.3 1.0 % ( baseline ) to 5.3 0.9 % ( endpoint ) .
RESULTS	There was no change in the placebo group .
RESULTS	The between-group difference in change from baseline was significant ( P = .013 ) .
RESULTS	Mean fasting plasma glucose concentration decreased over the study period with vildagliptin vs placebo by -1.0 mmol/L ( P = .018 ) , and there was a positive correlation between these decrements and liver triglyceride in the vildagliptin group at 3 months ( r = 0.47 ; P = .02 ) and 6 months ( r = 0.44 ; P = .03 ) .
RESULTS	Plasma alanine aminotransferase fell from 27.2 2.8 to 20.3 1.4 IU/L in the vildagliptin group ( P = .0007 ) , and there was a correlation between the decrements in alanine aminotransferase and liver triglyceride ( r = 0.83 ; P < .0001 ) .
RESULTS	Insulin sensitivity during the euglycemic clamp was similar in each group at baseline ( 3.24 0.30 vs 3.19 0.38 mg/kg/min ) and did not change ( adjusted mean change of 0.26 0.22 vs 0.32 0.22 mg/kg/min ; P = .86 ) .
RESULTS	Mean body weight decreased by 1.6 0.5 vs 0.4 0.5 kg in the vildagliptin and placebo groups , respectively ( P = .08 ) .
CONCLUSIONS	This study demonstrates that the dipeptidyl-peptidase-4 inhibitor vildagliptin brings about a clinically significant decrease in hepatic triglyceride levels during 6 months of therapy unrelated to change in body weight .
CONCLUSIONS	There was no change in peripheral insulin sensitivity .

###24899618
OBJECTIVE	To investigate the genomic response induced by ischaemic preconditioning ( IPC ) in muscle biopsies taken from the operative leg of total knee arthroplasty patients .
METHODS	The gene expression profile GSE21164 was extracted from Gene Expression Omnibus ( GEO ) database .
METHODS	Patients undergoing primary knee arthroplasty were randomized to control and treatment ( IPC ) groups .
METHODS	Muscle biopsies were taken from the quadriceps muscle of the operative knee at the immediate onset of surgery ( T0 ) and at 1 hour into surgery ( T1 ) .
METHODS	Limma package of R language was used to identify the differentially expressed genes ( DEGs ) between control and treatment group .
METHODS	To find out specific genes , DEGs at T0 were compared with DEGs at T1 .
METHODS	Scansite was used to find out the binding domain for specific DEGs .
METHODS	Functional enrichment analysis was done by DAVID .
RESULTS	Of the genes queried on the Affymetrix Human Genome U133 Plus 2.0 microarray , we identified 263 ( T0 ) and 266 ( T1 ) DEGs compared to the control group .
RESULTS	Down-regulation of DEGs related with regulation neuron apoptosis was observed at T1 .
RESULTS	The most significant function of DEGs at T0 was related with neurological system process .
RESULTS	The most specific DEG was FAM125B at T0 and T1 time points .
RESULTS	Its common binding domain was SH3 .
CONCLUSIONS	The protective effect of IPC was associated with altered expression of genes involved in neurological system process and regulation of neuron apoptosis .
CONCLUSIONS	The dynamic expression of FAM125B can be a supervised marker during the surgery .
CONCLUSIONS	IPC may be of potential benefit in this and other musculoskeletal conditions .

###24242260
BACKGROUND	Stigma associated with HIV has been documented as a barrier for accessing quality health-related services .
BACKGROUND	When the stigma manifests in the health care setting , people living with HIV receive substandard services or even be denied care altogether .
BACKGROUND	Although the consequences of HIV stigma have been documented extensively , efforts to reduce these negative attitudes have been scarce .
BACKGROUND	Interventions to reduce HIV stigma should be implemented as part of the formal training of future health care professionals .
BACKGROUND	The interventions that have been tested with health care professionals and published have several limitations that must be surpassed ( i.e. lack of comparison groups in research designs and longitudinal follow-up data ) .
BACKGROUND	Furthermore , Latino health care professionals have been absent from these intervention efforts even though the epidemic has affected this population disproportionately .
METHODS	In this article , we describe an intervention developed to reduce HIV stigma among medical students in Puerto Rico .
METHODS	A total of 507 medical students were randomly introduced into our intervention and control conditions .
RESULTS	The results show statistically significant differences between the intervention and control groups ; intervention group participants had lower HIV stigma levels than control participants after the intervention .
RESULTS	In addition , differences in HIV stigma levels between the groups were sustained for a 12-month period .
CONCLUSIONS	The results of our study demonstrate the efficacy of the modes of intervention developed by us and serve as a new training tool for future health care professionals with regard to stigma reduction .

###25190434
BACKGROUND	Treatment with pegylated interferon ( peg-IFN ) alfa-2a ( 40KD ) results in hepatitis B `` e '' antigen ( HBeAg ) seroconversion 6 months after treatment in up to 36 % of HBeAg-positive chronic hepatitis B patients .
BACKGROUND	This study explored the efficacy of a novel combination of peg-IFN alfa-2a and entecavir ( ETV ) , a potent nucleoside analogue .
METHODS	In total , 218 treatment-naive Chinese HBeAg-positive patients were randomized to peg-IFN alfa-2a ( 180 g/week ) for 48 weeks , either as monotherapy ( n = 72 ) , or with 24 weeks of ETV ( 0.5 mg/daily ) added at week 13 ( ETV add-on , n = 73 ) , or pretreatment with a 24-week course of ETV , starting peg-IFN alfa-2a at week 21 ( ETV pretreatment , n = 73 ) .
METHODS	The primary endpoint was reduction in quantitative HBeAg from baseline to 24 weeks posttreatment .
RESULTS	Significant reductions in HBeAg from baseline were achieved in all treatment groups 24 weeks posttreatment ; reductions were comparable across treatment arms ( shown as log10 Paul Ehrlich international units [ PEIU ] / mL ) : monotherapy : -1.4 ( SD , 1.8 ) ; ETV add-on : -1.6 ( SD , 1.8 ) ; ETV pretreatment : -1.3 ( SD , 1.7 ) .
RESULTS	Rates of HBeAg seroconversion were similar across treatment groups posttreatment ( monotherapy : 22 [ 31 % ] ; ETV add-on : 18 [ 25 % ] ; ETV pretreatment : 19 [ 26 % ] ) .
RESULTS	Significantly greater reductions of hepatitis B virus DNA were achieved with ETV add-on while on treatment , but were not sustained posttreatment .
RESULTS	Safety profiles were comparable between treatment groups ; adverse events were experienced by 62 ( 86 % ) monotherapy , 65 ( 89 % ) ETV add-on , and 58 ( 81 % ) ETV pretreatment patients .
CONCLUSIONS	Neither ETV add-on nor ETV pretreatment demonstrated superiority compared with 48 weeks of peg-IFN alfa-2a monotherapy .
CONCLUSIONS	The optimal treatment strategy using nucleos ( t ) ide analogues and peg-IFN alfa-2a remains to be determined .
CONCLUSIONS	Clinical Trials Registration.NCT00614471 .

###25335249
OBJECTIVE	To observe the clinical efficacy differences among warming-promotion acupuncture , regular acupuncture and psychological care for post-earthquake depression .
METHODS	Ninety cases of post-earthquake depression in Gansu province were randomly divided into a warming-promotion acupuncture group , a regular acupuncture group and a care group , 30 cases in each one .
METHODS	The psychological treatment was applied in the care group ; the regular acupuncture at Baihui ( GV 20 ) , Sishencong ( EX-HN 1 ) ) , Fengchi ( GB 20 ) , Shenmen ( HT 7 ) , Yang-lingquan ( GB 34 ) , Taichong ( LR 3 ) and Sanyinjiao ( SP 6 ) was used in the regular acupuncture group ; based on the treatment of regular acupuncture group , the warming-promotion acupuncture was applied in the warming-promotion acupuncture group , once a day .
METHODS	Ten days were taken as one course with an interval of two days between two courses .
METHODS	Totally 3 treatment courses were completed .
METHODS	The Hamilton depression ( HAMD ) scale before and after treatment in each group was observed while the efficacy was analyzed .
RESULTS	All three treatments were effective for depression .
RESULTS	The total cured rate was 86.67 % ( 26/30 ) in the warming-promotion acupuncture group , which was obviously superior to 50.00 % ( 15/30 ) in the regular acupuncture group ( P < 0.01 ) and 33.33 % ( 10/30 ) in the care group ( P < 0.001 ) .
RESULTS	After the treatment , the score of HAMD was all reduced in three groups , in which the effect in warming-promotion acupuncture group was superior to that in the regular acupuncture group and care group ( 9.02 + / - 2.37 vs 10.73 + / - 2.28 and 11.05 + / - 2.01 , P < 0.05 , P < 0.01 ) .
CONCLUSIONS	The warming-promotion acupuncture has positive effect on post-earthquake depression , which has special effect and is worthy of clinical generalization and application .

###24398824
BACKGROUND	Previous open-label studies have suggested that quetiapine could be a valuable alternative for treating fibromyalgia .
OBJECTIVE	This study aims to compare the efficacy and tolerability of extended-release quetiapine with amitriptyline for treating fibromyalgia .
METHODS	This study was a randomized , open-label , flexible-dose , non-inferiority trial .
METHODS	Patients with fibromyalgia were randomized to receive quetiapine extended-release ( XR ) ( N = 45 ) ( 50 to 300 mg daily ) or amitriptyline ( N = 45 ) ( 10 to 75 mg daily ) for 16 weeks .
METHODS	The primary endpoint was the change from baseline to endpoint in the Fibromyalgia Impact Questionnaire ( FIQ ) total score ; the non-inferiority threshold was established at 8 points .
METHODS	The secondary outcomes included sleep quality , anxiety , depression , and quality of life .
RESULTS	Twenty-two ( 49 % ) patients in the quetiapine group and 34 ( 76 % ) patients in the amitriptyline group completed the study .
RESULTS	We found a reduction of 9.8 points in the total FIQ score at the endpoint for the quetiapine-treated patients compared to 13.9 points for the amitriptyline-treated patients , for a difference of 4.14 points ( 80 % confidence interval ( CI ) -0.70 to 8.98 ) .
RESULTS	No significant differences were found between the quetiapine XR and amitriptyline groups for any of the secondary outcomes .
RESULTS	The proportion of patients discontinuing treatment due to adverse events was higher in the quetiapine group ( n = 14 , 31.1 % ) than the amitriptyline group ( n = 3 , 6.6 % ) .
CONCLUSIONS	Our results appear to indicate that quetiapine XR does not provide similar efficacy to amitriptyline for treating patients with fibromyalgia .
CONCLUSIONS	Quetiapine XR had a worse tolerability than amitriptyline in this population , possibly due to a relatively high starting dose .

###24760002
BACKGROUND	Elderly people do not mount strong immune responses to vaccines .
BACKGROUND	We compared 23-valent capsular polysaccharide ( 23vPPV ) alone versus 7-valent conjugate ( PCV7 ) vaccine followed by 23vPPV 6 months later in hospitalized elderly .
METHODS	Participants were randomized to receive 23vPPV or PCV7-23vPPV .
METHODS	Antibodies against serotypes 3 , 4 , 6A , 6B , 9V , 14 , 18C , 19A , 19F , 23F were measured by enzyme-linked immunosorbent ( ELISA ) and opsonophagocytic ( OPA ) assays at baseline , 6 months and 12 months .
RESULTS	Of 312 recruited , between 40 % and 72 % of subjects had undetectable OPA titres at baseline .
RESULTS	After one dose , PCV7 recipients had significantly higher responses to serotypes 9V ( both assays ) and 23F ( OPA only ) , and 23vPPV recipients had significantly higher responses to serotype 3 ( ELISA ) , 19F and 19A ( OPA only ) .
RESULTS	In subjects with undetectable OPA titres at baseline , a proportionately greater rise in OPA titre ( P < 0.01 ) was seen for all serotypes after both vaccines .
RESULTS	The GMT ratio of OPA was significantly higher at 12 months in the PCV7-23vPPV group for serotypes 6A , 9V , 18C and 23F .
RESULTS	OPA titre levels for these serotypes increased moderately after 6 months , whereas immunity waned in the 23vPPV only arm .
CONCLUSIONS	We did not show overwhelming benefit of one vaccine over the other .
CONCLUSIONS	Low baseline immunity does not preclude a robust immune response , reiterating the importance of vaccinating the frail elderly .
CONCLUSIONS	A schedule of PCV7-23vPPV prevents waning of antibody , suggesting that both vaccines could be useful in the elderly .
CONCLUSIONS	Follow up studies are needed to determine persistence of immunity .
BACKGROUND	The Australian Clinical Trials Registry ACTRN12607000387426 .

###24886906
BACKGROUND	The best criteria for surfactant treatment in the perinatal period are unknown and this makes it of interest to consider the possible economic implications of lessening the use of more restrictive criteria .
OBJECTIVE	The objective of this study is the evaluation of the costs of respiratory care for preterm infants with Respiratory Distress Syndrome ( RDS ) treated with `` early rescue '' surfactant compared to a `` late rescue '' strategy .
METHODS	The study was carried out applying the costs of materials used , of staff and pharmacological therapy calculated in the Neonatal Intensive Care Unit ( NICU ) of an Italian hospital to the Verder et al. study ( Pediatrics 1999 ) clinical data .
RESULTS	The cost for patients treated with early strategy was slightly lower than for patients treated with late strategy ( Euro 4,901.70 vs. Euro 4,960.07 ) .
RESULTS	The cost of treatment with surfactant was greater in the early group ( Euro 458.49 vs. Euro 311.74 ) , but this was compensated by the greater cost of treatment with Mechanical Ventilation ( MV ) in the late group ( respectively Euro 108.85 vs. Euro 259.25 ) .
CONCLUSIONS	The cost-effectiveness analysis performed in this study shows how early treatment with surfactant in preterm infants with RDS , as well as being clinically more effective , is associated with a slightly lower cost .

###25823275
OBJECTIVE	To evaluate the efficacy and safety of Arbidol ( umifenovir ) in adult patients with influenza .
METHODS	The analysis of the preliminary results of the multicenter double-blind randomized placebo-controlled post-marketing study ARBITR was performed .
METHODS	A total of 293 adults aged 18 to 65 years with influenza or acute respiratory tract infection of no more than 36 hours ' duration were enrolled in the study .
METHODS	Individuals were randomized into 2 treatment groups : oral umifenovir 200 mg four times daily for 5 days or placebo four times daily for 5 days .
METHODS	The efficacy endpoints were time to resolution of all symptoms , severity of symptoms and illness , durations of virus shedding .
RESULTS	The efficacy of umifenovir was evaluated in the group of 119 ( 40.6 % ) patients with influenza : 45 patients with laboratory-confirmed influenza and 74 patients whom diagnosis of influenza was made based on clinical and epidemiological data .
RESULTS	Umifenovir had influence on the time to resolution of all symptoms .
RESULTS	All symptoms were resolved within the first 60 hours after therapy initiation in 23.8 % patients with laboratory-confirmed influenza in the umifenovir group and it was 5.7 times greater compared to placebo group ( 4.2 % ) ( p < 0.05 ) .
RESULTS	Severity of illness , catarrhal symptoms and intoxication was reduced with umifenovir compared to placebo , reducing of severity was most evidently observed within the first 2-3 days following the therapy initiation .
RESULTS	Umifenovir had a significant effect on viral shedding .
RESULTS	The proportion of patients still shedding influenza virus on day 4 was significantly reduced in the umifenovir group compared to placebo ( 25 vs 53 % , respectively ; p < 0.05 ) .
CONCLUSIONS	It was found that the effect of umifenovir in the treatment of influenza in adults is most pronounced in the acute stage of the disease and appears in the reduction of time to resolution of all symptoms of the disease , reducing the severity of symptoms of the disease and durations of virus shedding .

###24906700
BACKGROUND	Median OS after surgery in curative intent for non-metastasized pancreas cancer ranges under study conditions from 17.9 months to 23.6 months .
BACKGROUND	Tumor recurrence occurs locally , at distant sites ( liver , peritoneum , lungs ) , or both .
BACKGROUND	Observational and autopsy series report local recurrence rates of up to 87 % even after potentially `` curative '' R0 resection .
BACKGROUND	To achieve better local control , neoadjuvant CRT has been suggested for preoperative tumour downsizing , to elevate the likelihood of curative , margin-negative R0 resection and to increase the OS rate .
BACKGROUND	However , controlled , randomized trials addressing the impact of neoadjuvant CRT survival do not exist .
METHODS	The underlying hypothesis of this randomized , two-armed , open-label , multicenter , phase III trial is that neoadjuvant CRT increases the three-year overall survival by 12 % compared to patients undergoing upfront surgery for resectable pancreatic cancer .
METHODS	A rigorous , standardized technique of histopathologically handling Whipple specimens will be applied at all participating centers .
METHODS	Overall , 410 patients ( n = 205 in each study arm ) will be enrolled in the trial , taking into regard an expected drop out rate of 7 % and allocated either to receive neoadjuvant CRT prior to surgery or to undergo surgery alone .
METHODS	Circumferential resection margin status , i.e. R0 and R1 rates , respectively , surgical resectability rate , local and distant disease-free and global survival , and first site of tumor recurrence constitute further essential endpoints of the trial .
CONCLUSIONS	For the first time , the NEOPA study investigates the impact of neoadjuvant CRT on survival of resectable pancreas head cancer in a prospectively randomized manner .
CONCLUSIONS	The results of the study have the potential to change substantially the treatment regimen of pancreas cancer .
BACKGROUND	Clinical Trial gov : NCT01900327 , DRKS00003893 , ISRCTN82191749 .

###25740262
OBJECTIVE	Assess the safety , tolerability , and pharmacokinetic ( PK ) profiles of daclatasvir ( DCV ) and asunaprevir ( ASV ) in healthy male Japanese subjects .
METHODS	AI444-007 and AI447-005 were phase I , double-blind , placebo-controlled , sequential , single-ascending dose ( SAD ) , and multiple-ascending dose ( MAD ) studies assessing DCV or ASV , respectively .
METHODS	Eight subjects per panel were randomized to study drug or placebo ( 3 : 1 ) .
METHODS	In the SAD part of each study , subjects received single oral dose DCV 1/10/50 / 100/200 mg or ASV 200/400/600 / 900/1 ,200 mg .
METHODS	In MAD , subjects received 14-day oral multiple dose DCV 1/10/100 mg once-daily or ASV 200/400/600 mg every 12 hours .
METHODS	Serial PK blood sampling occurred from predose to 72-hours postdose or post-last-dose .
METHODS	Safety and tolerability was assessed throughout .
RESULTS	64 ( SAD , n = 40 ; MAD , n = 24 ) and 65 ( SAD , n = 40 ; MAD , n = 25 ) subjects were enrolled in AI444-007 and AI447-005 , respectively .
RESULTS	DCV and ASV were generally well tolerated , with no serious adverse events or clinicallyrelevant changes in vital signs or ECG parameters .
RESULTS	Baseline demographic characteristics were comparable across treatment groups in both studies .
RESULTS	DCV was readily absorbed , with median tmax of ~ 1 - 2 hours postdose and concentrations declining in a multi-phasic manner .
RESULTS	Exposure generally increased dose-proportionally within dose-range studied .
RESULTS	Steady-state was achieved between days 4 and 5 of multiple dosing .
RESULTS	ASV was readily absorbed , with median tmax of ~ 2 - 4 hours postdose and concentrations declining in a biphasic manner .
RESULTS	Exposure generally increased dose-proportionally within dose-range studied .
RESULTS	Steady-state appeared to be achieved between days 3 - 5 of multiple dosing .
CONCLUSIONS	Results suggest no clinically significant short-term safety signals with DCV and ASV at single or multiple doses in this population .

###25201095
BACKGROUND	The use of animals to augment traditional medical therapies was reported as early as the 9th century but to our knowledge has not been studied in an orthopaedic patient population .
BACKGROUND	The purpose of this study was to evaluate the role of animal-assisted therapy using therapy dogs in the postoperative recovery of patients after THA and TKA .
OBJECTIVE	We asked : ( 1 ) Do therapy dogs have an effect on patients ' perception of pain after total joint arthroplasty as measured by the VAS ?
OBJECTIVE	( 3 ) Do therapy dogs have an effect on patients ' satisfaction with their hospital stay after total joint arthroplasty as measured by the Hospital Consumer Assessment of Healthcare Providers and Systems ( HCAHPS ) ?
METHODS	A randomized controlled trial of 72 patients undergoing primary unilateral THA or TKA was conducted .
METHODS	Patients were randomized to a 15-minute visitation with a therapy dog before physical therapy or standard postoperative physical therapy regimens .
METHODS	Both groups had similar demographic characteristics .
METHODS	Reduction in pain was assessed using the VAS after each physical therapy session , beginning on postoperative Day 1 and continuing for three consecutive sessions .
METHODS	To ascertain patient satisfaction , the proportion of patients selecting top-category ratings in each subsection of the HCAHPS was compared .
RESULTS	Patients in the treatment group had lower VAS scores after each physical therapy session with a final VAS score difference of 2.4 units ( animal-assisted therapy VAS , 1.7 ; SD , 0.97 [ 95 % CI , 1.4-2 .0 ] versus control VAS , 4.1 ; SD , 0.97 [ 95 % CI , 3.8-4 .4 ] , p < 0.001 ) after the third physical therapy session .
RESULTS	Patients in the treatment group had a higher proportion of top-box HCAHPS scores in the following fields : nursing communication ( 33 of 36 , 92 % [ 95 % CI , 78 % -98 % ] versus 69 % , 25 of 36 [ 95 % CI , 52 % -84 % ] , p = 0.035 ; risk ratio , 1.3 [ 95 % CI of risk ratio , 1.0-1 .7 ] ; risk difference , 23 % [ 95 % CI of risk difference , 5 % -40 % ] ) , pain management ( 34 of 36 , 94 % [ 95 % CI , 81 % -99 % ] , versus 26 of 36 , 72 % [ 95 % CI , 55 % -86 % ] , p = 0.024 ; risk ratio , 1.3 [ 95 % CI of risk ratio , 1.1-1 .6 ] ; risk difference , 18 % [ 95 % CI of risk difference , 5 % -39 % ] ) .
RESULTS	The overall hospital rating also was greater in the treatment group ( 0-10 scale ) ( 9.6 ; SD , 0.7 [ 95 % CI , 9.3-9 .8 ] versus 8.6 , SD , 0.9 [ 95 % CI , 8.3-8 .9 ] , p < 0.001 ) .
CONCLUSIONS	The use of therapy dogs has a positive effect on patients ' pain level and satisfaction with hospital stay after total joint replacement .
CONCLUSIONS	Surgeons are encouraged to inquire about the status of volunteer-based animal-assisted therapy programs in their hospital as this may provide a means to improve the immediate postoperative recovery for a select group of patients having total joint arthroplasty .
METHODS	Level II , randomized controlled study .
METHODS	See Instructions for Authors for a complete description of levels of evidence .

###24528605
OBJECTIVE	The efficacy and safety of canagliflozin , a sodium glucose co-transporter 2 inhibitor , was evaluated in patients with type 2 diabetes mellitus ( T2DM ) inadequately controlled with metformin and pioglitazone .
METHODS	In this randomized , double-blind , phase 3 study , patients ( N = 342 ) received canagliflozin 100 or 300mg during a 26-week , placebo-controlled , core period and a 26-week , active-controlled extension in which placebo-treated patients were switched to sitagliptin 100mg .
METHODS	Efficacy comparisons for canagliflozin versus placebo at week 26 are reported , with no comparisons versus sitagliptin at week 52 ( sitagliptin used to maintain double-blind and control for safety ) .
METHODS	Safety data are reported for canagliflozin and placebo/sitagliptin .
RESULTS	Canagliflozin 100 and 300mg significantly lowered haemoglobin A1c ( HbA1c ) compared with placebo at week 26 ( -0.89 % , -1.03 % and -0.26 % ; p < 0.001 ) ; reductions with canagliflozin 100 and 300mg were maintained at week 52 ( -0.92 % and -1.03 % ) .
RESULTS	Relative to placebo , both canagliflozin doses significantly reduced body weight ( -2.5 and -3.5 kg ) , fasting plasma glucose and systolic blood pressure ( BP ) at week 26 ( p < 0.05 for all ) , with reductions maintained at week 52 .
RESULTS	Overall adverse event ( AE ) incidence over 52 weeks was 69.9 , 76.3 and 76.5 % with canagliflozin 100 and 300mg and placebo/sitagliptin ; AE-related discontinuation and serious AE rates were low .
RESULTS	Incidences of genital mycotic infections and AEs related to osmotic diuresis and volume depletion were higher with canagliflozin than placebo/sitagliptin .
CONCLUSIONS	Canagliflozin improved glycaemic control , reduced body weight and systolic BP , and was generally well tolerated in patients with T2DM on metformin and pioglitazone over 52 weeks .

###24592952
BACKGROUND	Delivery of a pharmacologically effective drug dosage to a target tissue is critical .
BACKGROUND	Barrett 's epithelia are a unique challenge for drug delivery of orally administered zinc due to rapid transit down the esophageal lumen , incomplete absorptive differentiation of these epithelia , and the use of proton-pump inhibitor drugs abrogating intestinal uptake of supplemental zinc .
METHODS	Barrett 's esophagus patients were administered oral zinc gluconate ( 26 mg zinc twice daily ) for 14 days prior to biopsy procurement .
METHODS	Barrett 's biopsies were analyzed for total zinc content by atomic absorption spectroscopy and by western immunoblot for cellular proteins known to be regulated by zinc .
RESULTS	Cellular levels of both the Znt-1 transport protein and the alpha isoform of PKC were over 50 % lower in the zinc treatment group .
CONCLUSIONS	Oral zinc administration can result in effective delivery of zinc to Barrett 's epithelia with resulting effects on intracellular signal transduction .

###24751903
BACKGROUND	Ribavirin ( RBV ) remains part of several interferon-free treatment strategies even though its mechanisms of action are still not fully understood .
BACKGROUND	One hypothesis is that RBV increases responsiveness to type I interferons .
BACKGROUND	Pegylated Interferon alpha ( PEG-IFNa ) has recently been shown to alter natural killer ( NK ) cell function possibly contributing to control of hepatitis C virus ( HCV ) infection .
BACKGROUND	However , the effects of ribavirin alone or in combination with IFNa on NK cells are unknown .
METHODS	Extensive ex vivo phenotyping and functional analysis of NK cells from hepatitis C patients was performed during antiviral therapy .
METHODS	Patients were treated for 6 weeks with RBV monotherapy ( n = 11 ) , placebo ( n = 13 ) or PEG-IFNa-2a alone ( n = 6 ) followed by PEG-IFNa/RBV combination therapy .
METHODS	The effects of RBV and PEG-IFNa-2a on NK cells were also studied in vitro after co-culture with K562 or Huh7 .5 cells .
RESULTS	Ribavirin monotherapy had no obvious effects on NK cell phenotype or function , neither ex vivo in patients nor in vitro .
RESULTS	In contrast , PEG-IFNa-2a therapy was associated with an increase of CD56bright cells and distinct changes in expression profiles leading to an activated NK cell phenotype , increased functionality and decline of terminally differentiated NK cells .
RESULTS	Ribavirin combination therapy reduced some of the IFN effects .
RESULTS	An activated NK cell phenotype during therapy was inversely correlated with HCV viral load .
CONCLUSIONS	PEG-IFNa activates NK cells possibly contributing to virological responses independently of RBV .
CONCLUSIONS	The role of NK cells during future IFN-free combination therapies including RBV remains to be determined .

###25324251
BACKGROUND	Hyperoxemic management during cardiopulmonary bypass ( CPB ) is still common , and there is no consensus about physiologic oxygen tension strategy ( normoxemic management ) during pediatric CPB .
BACKGROUND	In this study , we compared the postoperative conditions and measures of inflammatory response among patients with acyanotic congenital heart disease subjected to either hyperoxemic or normoxemic management strategy during CPB .
METHODS	We studied 22 patients with a ventricular septal defect and pulmonary artery hypertension .
METHODS	The patients were divided into two groups .
METHODS	Group I ( n = 9 ) received normoxemic management ( PaO2 = 100-150 mm Hg ) and group II ( n = 13 ) received hyperoxemic management ( PaO2 = 200-300 mm Hg ) during CPB .
METHODS	There was no difference between groups with regard to age , body weight , duration of CPB , and aorta clamping time or preoperative pulmonary hypertension ( pulmonary pressure/systemic pressure [ Pp/Ps ] ) .
METHODS	In each group , the blood samples to measure the cytokine levels were collected before and after the CPB .
RESULTS	Although we observed no statistically significant differences in postoperative intubation time , alveolar-arterial oxygen difference , creatine kinase MB level , and pulmonary hypertension ( Pp/Ps ) between group I ( 10.713.4 hours , 197132 mm Hg , 14858.6 IU/L , 42.8 % 22.1 % , respectively ) and group II ( 27.836.5 hours , 227150 mm Hg , 15172.6 IU/L , 50.4 % 16.0 % , respectively ) , levels of median interleukin 6 and tumor necrosis factor were lower in group I ( 129.8 and 17.0 pg/mL , respectively ) than that in group II ( 487.8 and 22.5 pg/mL , respectively ) .
CONCLUSIONS	During the CPB in acyanotic pediatric patients , normoxemic management can minimize the systemic inflammatory response syndrome associated with CPB .
CONCLUSIONS	We can apply this physiologic oxygen tension strategy to surgical advantage during heart surgeries in acyanotic pediatric patients .

###25371147
OBJECTIVE	Worsening heart failure ( WHF ) in the first 7 days after an admission for acute HF ( AHF ) has been proposed as a therapeutic target in several recent AHF studies and was a co-primary endpoint of the VERITAS studies .
RESULTS	Patients were randomized within 24h of admission for AHF .
RESULTS	WHF was defined as worsening or persistent signs and symptoms of HF requiring additional intravenous or mechanical therapy for HF or death within 7 days of randomization .
RESULTS	Multivariable models were developed to predict the time to WHF through day 7 .
RESULTS	Unadjusted and multivariable-adjusted associations of WHF with the length of stay ( LOS ) of the index hospitalization , and 30 - and 90-day outcomes were estimated .
RESULTS	WHF occurred by day 7 in 27 % of the 1347 patients enrolled .
RESULTS	Age , co-morbidities , and markers of HF severity were moderately predictive of WHF ; the C-index for a multivariable model for WHF was 0.66 .
RESULTS	After multivariable adjustment for baseline characteristics , WHF was associated with an increase in LOS of 4.33 days [ 95 % confidence interval ( CI ) 3.54-5 .13 days ] , a hazard ratio ( HR ) for 30-day HF readmission or death of 2.43 ( 95 % CI 1.75-3 .40 ) , and a HR for 90-day mortality of 2.57 ( 95 % CI 1.81-3 .65 ) , all with P < 0.0001 .
RESULTS	The associations of WHF with these outcomes remained largely unchanged after adjustment for both baseline characteristics and changes in markers of renal and hepatic dysfunction during the first day of admission .
CONCLUSIONS	In patients admitted for AHF , WHF is a significant clinical event that is associated with delays in discharge and higher rates for readmission and death .

###25587218
OBJECTIVE	Persons with mild dementia experience multiple losses and manifest depressive symptoms .
OBJECTIVE	This research study aimed to evaluate the effectiveness of a support group led by a social worker for Chinese persons with mild dementia .
METHODS	Participants were randomly assigned to either a ten-session support group or a control group .
METHODS	Standardized assessment tools were used for data collection at pretreatment and post-treatment periods by a research assistant who was kept blind to the group assignment of the participants .
METHODS	Upon completion of the study , 20 treatment group participants and 16 control group participants completed all assessments .
RESULTS	At baseline , the treatment and control groups did not show any significant difference on all demographic variables , as well as on all baseline measures ; over one-half ( 59 % ) of all the participants reported having depression , as assessed by a Chinese Geriatric Depression Scale score 8 .
RESULTS	After completing the support group , the depressive mood of the treatment group participants reduced from 8.83 ( standard deviation = 2.48 ) to 7.35 ( standard deviation = 2.18 ) , which was significant ( Wilcoxon signed-rank test ; P = 0.017 , P < 0.05 ) , while the control group 's participants did not show any significant change .
CONCLUSIONS	This present study supports the efficacy and effectiveness of the support group for persons with mild dementia in Chinese society .
CONCLUSIONS	In particular , this present study shows that a support group can reduce depressive symptoms for participants .

###25740906
BACKGROUND	Green tea ( GT ) extract may play a role in body weight regulation .
BACKGROUND	Suggested mechanisms are decreased fat absorption and increased energy expenditure .
OBJECTIVE	We examined whether GT supplementation for 12 wk has beneficial effects on weight control via a reduction in dietary lipid absorption as well as an increase in resting energy expenditure ( REE ) .
METHODS	Sixty Caucasian men and women [ BMI ( in kg/m ) : 18-25 or > 25 ; age : 18-50 y ] were included in a randomized placebo-controlled study in which fecal energy content ( FEC ) , fecal fat content ( FFC ) , resting energy expenditure , respiratory quotient ( RQ ) , body composition , and physical activity were measured twice ( baseline vs. week 12 ) .
METHODS	For 12 wk , subjects consumed either GT ( > 0.56 g/d epigallocatechin gallate + 0.28-0 .45 g/d caffeine ) or placebo capsules .
METHODS	Before the measurements , subjects recorded energy intake for 4 consecutive days and collected feces for 3 consecutive days .
RESULTS	No significant differences between groups and no significant changes over time were observed for the measured variables .
RESULTS	Overall means SDs were 7.2 3.8 g/d , 6.1 1.2 MJ/d , 67.3 14.3 kg , and 29.8 8.6 % for FFC , REE , body weight , and body fat percentage , respectively .
CONCLUSIONS	GT supplementation for 12 wk in 60 men and women did not have a significant effect on FEC , FFC , REE , RQ , and body composition .

###26158868
OBJECTIVE	The optimum size of endotracheal tube ( ETT ) for general anesthesia remains unresolved .
OBJECTIVE	Choice of ETT size may be of particular relevance to thyroid surgery because of the increased risk of laryngeal trauma and concerns regarding postoperative vocal outcomes .
OBJECTIVE	To test our hypothesis that intubation with a smaller ETT would lead to reduced postoperative vocal impairment and associated reduced laryngoscopic evidence of laryngeal trauma compared with intubation with a standard-size ETT .
METHODS	This double-blind randomized clinical trial studied patients 18 years and older undergoing elective thyroidectomy at an academic teaching hospital from October 15 , 2012 , through June 13 , 2013 .
METHODS	Patients were randomized to group 1 ( standard-size ETT , 8.0 mm for men and 7.5 mm for women ; n = 24 ) or group 2 ( small ETT , 7.0 mm for men and 6.5 mm for women ; n = 25 ) .
METHODS	Patients were assessed preoperatively and at 24 hours and 3 weeks postoperatively .
METHODS	Fiberoptic videolaryngoscopy with modified scoring system , voice assessment using the GRBAS ( grade , roughness , breathiness , asthenia , strain ) rating scale , vocal self-assessment using the 30-item Voice Handicap Index , and subjective pain score .
RESULTS	At 24 hours , no significant differences were found between patients in groups 1 and 2 in change in GRBAS scores , change in laryngoscopic score ( 1.71 vs 1.76 , P = .90 ) , or postoperative pain score ( 3.3 vs 3.2 , P = .91 ) .
RESULTS	At 3 weeks , no significant differences were found in changes in the 30-item Voice Handicap Index score ( -2.2 vs -1.3 , P = .74 ) , GRBAS scores , or laryngoscopic score ( 0.25 vs 0.16 , P = .67 ) .
CONCLUSIONS	We did not find evidence that smaller ETT size for thyroidectomy has any significant effect on postoperative vocal outcomes , incidence of laryngeal trauma as assessed by laryngoscopy , or pain scores .
CONCLUSIONS	However , because of the small sample size , our study may have been underpowered to detect small differences .
BACKGROUND	clinicaltrials.gov Identifier : NCT02136459 .

###25107946
OBJECTIVE	Recent developments of open irrigated catheters have sought to create uniform cooling of the entire ablating electrode .
OBJECTIVE	The aim of this randomized study was to assess whether the diffuse irrigation of the Coolflex ( ) ( CF ) catheter results in improved short-term procedural benefits in patients undergoing ablation of right atrial typical flutter .
RESULTS	Sixty consecutive patients ( age 62 13 ) with typical atrial flutter were prospectively randomized to ablation of the cavotricuspid isthmus ( CTI ) using either a standard 3.5 mm tip ablation catheter with six distal irrigation channels ( 6C ) ( 30 patients ) or a 4 mm tip fully irrigated ablation catheter ( CF ) ( 30 patients ) .
RESULTS	There were no significant differences seen between procedures performed with the diffusely irrigated CF catheter and the standard six-channel irrigated-tip catheter .
RESULTS	This concerned the total procedural duration RF duration , fluoroscopic duration , the total amount of irrigation fluid , and the occurrence of steam pop .
CONCLUSIONS	The use of a diffuse irrigation at the ablation catheter tip does neither facilitate lesion formation nor reduce the amount of irrigation during RF ablation for typical right atrial flutter using recommended flow and power settings .

###25824327
OBJECTIVE	To assess the association of the vitreomacular interface with outcomes of eyes treated with anti-vascular endothelial growth factor drugs for neovascular age-related macular degeneration ( AMD ) .
METHODS	Prospective cohort study within a multicenter , randomized clinical trial .
METHODS	Patients enrolled in the Comparison of AMD Treatments Trials ( CATT ) .
METHODS	Treatment was assigned randomly as either ranibizumab or bevacizumab and as 3 different regimens for dosing over a 2-year period .
METHODS	Masked readers at a reading center assessed optical coherence tomography ( OCT ) scans at baseline and follow-up for vitreomacular traction ( VMT ) and vitreomacular adhesion ( VMA ) , fluid , and central thickness .
METHODS	Visual acuity ( VA ) was measured by masked , certified examiners .
METHODS	Anatomic features and VA at baseline and 1 and 2 years and number of treatments .
RESULTS	At baseline , 143 patient eyes ( 12.8 % ) had VMT or VMA .
RESULTS	Compared with those with neither ( n = 972 ) , patients with VMT or VMA were younger ( mean standard error , 75.5 0.6 vs. 79.7 0.24 years ; P < 0.0001 ) and more likely to be male ( 52.4 % vs. 36.2 % ; P = 0.0003 ) , to be cigarette smokers ( 68.5 % vs. 55.3 % ; P = 0.003 ) , and to have subretinal fluid on OCT ( 86.7 % vs. 81.0 % ; P = 0.047 ) .
RESULTS	Vitreomacular interface status was not associated with VA at baseline or follow-up .
RESULTS	Among eyes treated as needed ( n = 598 ) and followed up for 2 years ( n = 516 ) , the mean number of injections was 15.4 0.9 for eyes having VMT at baseline or during follow-up ( n = 60 ) , 13.8 0.7 for eyes with VMA at baseline or follow-up ( n = 79 ) , and 12.9 0.4 ( P = 0.02 ) for eyes without VMT or VMA ( n = 377 ) .
RESULTS	In addition , the mean number of injections in eyes treated as needed increased from 13.0 0.3 when VMT was not observed to 13.6 1.3 when observed once and to 17 1.2 when observed more than once during follow-up .
RESULTS	At 2 years , geographic atrophy developed in a lower percentage of eyes with VMT or VMA at baseline ( 11.7 % ) than with neither condition ( 22.5 % ; P = 0.005 ) .
CONCLUSIONS	In eyes in the CATT , VMT and VMA were infrequent .
CONCLUSIONS	At baseline and follow-up , VMT or VMA were not associated with VA. .
CONCLUSIONS	Eyes with VMT or VMA treated as needed required on average 2 more injections over 2 years .

###24912663
OBJECTIVE	To evaluate the efficacy of resiniferatoxin in the treatment of patients with lifelong premature ejaculation .
METHODS	A total of 41 outpatients ( mean age 26.144 years ) with premature ejaculation completed the present study .
METHODS	They were randomly separated into the resiniferatoxin group and the placebo group .
METHODS	The resiniferatoxin group included 11 patients with redundant prepuce and 10 patients without redundant prepuce , whereas the placebo group contained 10 patients with redundant prepuce and 10 patients without .
METHODS	For the treatment , the glans were respectively soaked in 30mL of resiniferatoxin with a concentration of 100nmol/L or 10 % alcohol solution for 30min before sexual intercourse .
METHODS	Clinical efficacy was assessed by using the Chinese Index of Sexual Function for Premature Ejaculation-5 and the intravaginal ejaculation latency time before or 4 weeks after the treatment .
METHODS	The side-effects were also evaluated .
RESULTS	In the resiniferatoxin group , the effective rate of patients with redundant prepuce was 63.6 % , and both the intravaginal ejaculation latency time and Chinese Index of Sexual Function for Premature Ejaculation-5 significantly increased ( P < 0.05 ) .
RESULTS	However , the effective rate of patients without redundant prepuce was 20 % , and there were no significant changes of their intravaginal ejaculation latency time and Chinese Index of Sexual Function for Premature Ejaculation-5 before and after the resiniferatoxin treatment ( P > 0.05 ) .
RESULTS	The total effective rate of patients treated with resiniferatoxin was 42.9 % .
RESULTS	In the placebo group , the effective rate of patients with or without redundant prepuce was 20 % and 10 % , respectively .
RESULTS	The total effective rate of patients treated with placebo was 15 % , and there were no significant changes of their intravaginal ejaculation latency time and Chinese Index of Sexual Function for Premature Ejaculation-5 before and after the placebo treatment ( P > 0.05 ) .
RESULTS	The side-effects included a slight burning sensation for the glans penis and dysuria .
CONCLUSIONS	These preliminary results show that resiniferatoxin might be suitable for treating patients with lifelong premature ejaculation and particularly those with redundant prepuce .

###24297654
OBJECTIVE	Circumferential excisional hemorrhoidectomy ( CEH ) enables the surgeon to remove the encircling hemorrhoids completely .
OBJECTIVE	The purpose of this study is to compare the efficacy of CEH with that of Ferguson hemorrhoidectomy ( FH ) for end-stage hemorrhoids .
METHODS	Between February 1998 and December 2011 , a prospective randomized trial was conducted with 688 patients who presented with end-stage hemorrhoids and underwent FH or CEH at our center .
RESULTS	The patient demographics , mean operative times , lengths of hospital stay , and cumulative rates of postoperative complications were similar in the study groups .
RESULTS	Significant differences were revealed in the incidence of postoperative hemorrhage ( 9 vs. 0 patients in the FH and CEH groups , respectively ; p = 0.002 ) and in the tendency to form anal stricture ( 15 vs. 32 patients in the FH and CEH groups , respectively ; p = 0.02 ) .
RESULTS	However , all cases of anal strictures were easily managed by digital dilatations .
RESULTS	At a mean follow-up of 7.4 ( range , 1-14 ) years , accessible patients from the CEH group remained symptom free , whereas 126 of 308 patients in the FH group indicated that they had recurrent hemorrhoidal symptoms .
CONCLUSIONS	Without increasing postoperative complications , CEH demonstrates an advantage compared with FH , with regard to reducing the rate of recurrence to 0 through complete hemorrhoid removal .

###24966007
BACKGROUND	In developing countries , accessibility to specialists , and physician to patient contact time is limited .
BACKGROUND	In Thailand , A unique community health service is provided by subdistrict health care officers and Village Health Volunteers ( VHVs ) .
BACKGROUND	If the personnel were trained on proper chronic kidney disease ( CKD ) care , CKD progression would be delayed .
METHODS	We conducted a community-based , cluster randomized controlled trial at Kamphaeng Phet Province , located about 400 kilometers north of Bangkok .
METHODS	Two out of eleven districts of the province were randomly selected .
METHODS	Approximatly 500 stage 3-4 CKD patients from 2 districts were enrolled .
METHODS	Patients in both groups will be treated with standard guidelines .
METHODS	The patients in intervention group were provided the additional treatments by multidisciplinary team in conjunction with community CKD care network ( subdistrict health care officers and VHVs ) which will provide group counseling during each hospital visit and quarterly home visits to monitor dietary protein and sodium intake , blood pressure measurement and drug compliance .
METHODS	Duration of the study is 2years .
METHODS	The primary outcome is the difference of rate of eGFR decline .
METHODS	The secondary outcomes are laboratory parameters and incidence of clinical endpoints such as mortality rate and cardiovascular events , end-stage renal disease ( ESRD ) , etc. .
CONCLUSIONS	Insights of this study may set forth a new standard of community-based CKD care .
BACKGROUND	NCT01978951 .

###25014686
BACKGROUND	Patients with evidence of vascular disease are at increased risk for subsequent vascular events despite effective use of statins to lower the low-density lipoprotein ( LDL ) cholesterol level .
BACKGROUND	Niacin lowers the LDL cholesterol level and raises the high-density lipoprotein ( HDL ) cholesterol level , but its clinical efficacy and safety are uncertain .
METHODS	After a prerandomization run-in phase to standardize the background statin-based LDL cholesterol-lowering therapy and to establish participants ' ability to take extended-release niacin without clinically significant adverse effects , we randomly assigned 25,673 adults with vascular disease to receive 2 g of extended-release niacin and 40 mg of laropiprant or a matching placebo daily .
METHODS	The primary outcome was the first major vascular event ( nonfatal myocardial infarction , death from coronary causes , stroke , or arterial revascularization ) .
RESULTS	During a median follow-up period of 3.9 years , participants who were assigned to extended-release niacin-laropiprant had an LDL cholesterol level that was an average of 10 mg per deciliter ( 0.25 mmol per liter as measured in the central laboratory ) lower and an HDL cholesterol level that was an average of 6 mg per deciliter ( 0.16 mmol per liter ) higher than the levels in those assigned to placebo .
RESULTS	Assignment to niacin-laropiprant , as compared with assignment to placebo , had no significant effect on the incidence of major vascular events ( 13.2 % and 13.7 % of participants with an event , respectively ; rate ratio , 0.96 ; 95 % confidence interval [ CI ] , 0.90 to 1.03 ; P = 0.29 ) .
RESULTS	Niacin-laropiprant was associated with an increased incidence of disturbances in diabetes control that were considered to be serious ( absolute excess as compared with placebo , 3.7 percentage points ; P < 0.001 ) and with an increased incidence of diabetes diagnoses ( absolute excess , 1.3 percentage points ; P < 0.001 ) , as well as increases in serious adverse events associated with the gastrointestinal system ( absolute excess , 1.0 percentage point ; P < 0.001 ) , musculoskeletal system ( absolute excess , 0.7 percentage points ; P < 0.001 ) , skin ( absolute excess , 0.3 percentage points ; P = 0.003 ) , and unexpectedly , infection ( absolute excess , 1.4 percentage points ; P < 0.001 ) and bleeding ( absolute excess , 0.7 percentage points ; P < 0.001 ) .
CONCLUSIONS	Among participants with atherosclerotic vascular disease , the addition of extended-release niacin-laropiprant to statin-based LDL cholesterol-lowering therapy did not significantly reduce the risk of major vascular events but did increase the risk of serious adverse events .
CONCLUSIONS	( Funded by Merck and others ; HPS2-THRIVE ClinicalTrials.gov number , NCT00461630 . )

###24621972
OBJECTIVE	This study sought to assess the effect of the addition of coronary artery bypass grafting ( CABG ) to medical therapy on mode of death in heart failure .
BACKGROUND	Although CABG therapy is widely used in ischemic cardiomyopathy patients , there are no prospective clinical trial data on mode of death .
METHODS	The STICH ( Surgical Treatment for Ischemic Heart Failure ) trial compared the strategy of CABG plus medical therapy to medical therapy alone in 1,212 ischemic cardiomyopathy patients with reduced ejection fraction .
METHODS	A clinical events committee adjudicated deaths using pre-specified definitions for mode of death .
RESULTS	In the STICH trial , there were 462 deaths over a median follow-up of 56 months .
RESULTS	The addition of CABG therapy tended to reduce cardiovascular deaths ( hazard ratio [ HR ] : 0.83 ; 95 % confidence interval [ CI ] : 0.68 to 1.03 ; p = 0.09 ) and significantly reduced the most common modes of death : sudden death ( HR : 0.73 ; 95 % CI : 0.54 to 0.99 ; p = 0.041 ) and fatal pump failure events ( HR : 0.64 ; 95 % CI : 0.41 to 1.00 ; p = 0.05 ) .
RESULTS	Time-dependent estimates indicate that the protective effect of CABG principally occurred after 24 months in both categories .
RESULTS	Deaths post-cardiovascular procedures were increased in CABG patients ( HR : 3.11 ; 95 % CI : 1.47 to 6.60 ) , but fatal myocardial infarction deaths were lower ( HR : 0.07 ; 95 % CI : 0.01 to 0.57 ) .
RESULTS	Noncardiovascular deaths were infrequent and did not differ between groups .
CONCLUSIONS	In the STICH trial , the addition of CABG to medical therapy reduced the most common modes of death : sudden death and fatal pump failure events .
CONCLUSIONS	The beneficial effects were principally seen after 2 years .
CONCLUSIONS	Post-procedure deaths were increased in patients randomized to CABG , whereas myocardial infarction deaths were decreased .

###24377215
OBJECTIVE	To evaluate the effect of Chen 's needling therapy on facial neuritis .
METHODS	Eighty-four patients of facial neuritis were randomized into a Chen 's needling therapy group and a conventional needling group , 42 cases in each one .
METHODS	In the Chen 's needling therapy group , the few acupoints were selected ( 5 acupoints ) .
METHODS	Chen 's flying insertion of needle and the reinforcing and reducing techniques were applied .
METHODS	In the conventional needling group , the acupoint selection and needling method were used routinely .
METHODS	The treatment of 1 month was 1 session in the two groups .
METHODS	According to the symptom and physical sign quantification scale , the effect was assessed at multiple time points respectively ( in 2 weeks of treatment , 1 session of treatment and 1 month after 1 session of treatment ) .
METHODS	Simultaneously , House-Brackmann scale and EMG were adopted to determine the function of facial nerve .
RESULTS	After treatment , the results of symptoms and physical sign quantification scale and facial nerve EMG were different significantly as compared with those before treatment in the patients of the two groups ( all P < 0.05 ) .
RESULTS	But the differences were not significant between the two groups ( all P > 0.05 ) .
CONCLUSIONS	Chen 's needling therapy achieves the same effect on facial neuritis as compared with the conventional acupuncture therapy , and additionally it is specialized at flying insertion of needle technique and selection of few acupoints .

###25965711
BACKGROUND	In the Effects of Postconditioning on Myocardial Reperfusion in Patients with ST-segment Elevation Myocardial Infarction ( POST ) trial , ischemic postconditioning failed to improve myocardial reperfusion .
BACKGROUND	However , long-term effects of ischemic postconditioning on clinical outcomes are not known in patients with ST-segment elevation myocardial infarction .
METHODS	A total of 700 patients undergoing primary percutaneous coronary intervention ( PCI ) were randomly assigned to the postconditioning group or the conventional primary PCI group in a 1:1 ratio .
METHODS	Postconditioning was performed immediately after restoration of coronary flow by balloon occlusion 4 times for 1 minute .
METHODS	Complete follow-up data for major clinical events at 1 year were available in 695 patients ( 99.3 % ) , and analyses were done by the intention to treat principle .
METHODS	The primary outcome was a composite of death , myocardial infarction , severe heart failure , or stent thrombosis at 1 year .
RESULTS	At 1 year , a composite of death , myocardial infarction , severe heart failure , or stent thrombosis occurred in 21 patients ( 6.1 % ) in the postconditioning group and 16 patients ( 4.6 % ) in the conventional PCI group ( hazard ratio [ HR ] 1.32 , 95 % CI 0.69-2 .53 , P = .40 ) .
RESULTS	The risk of death ( 4.9 % vs 3.7 % , HR 1.32 , 95 % CI 0.64-2 .71 , P = .46 ) , heart failure ( 2.6 % vs 2.3 % , HR 1.13 , 95 % CI 0.44-2 .94 , P = .80 ) , and stent thrombosis ( 2.3 % vs 1.7 % , HR 1.34 , 95 % CI 0.46-3 .85 , P = .59 ) did not differ significantly between the 2 groups .
CONCLUSIONS	Ischemic postconditioning does not seem to improve the 1-year clinical outcomes in patients with ST-segment elevation myocardial infarction undergoing primary PCI .

###25542039
OBJECTIVE	To investigate the effectiveness of a worksite social and physical environment intervention on need for recovery ( i.e. , early symptoms of work-related mental and physical fatigue ) , physical activity and relaxation .
OBJECTIVE	Also , the effectiveness of the separate interventions was investigated .
METHODS	In this 2 2 factorial design study , 412 office employees from a financial service provider participated .
METHODS	Participants were allocated to the combined social and physical intervention , to the social intervention only , to the physical intervention only or to the control group .
METHODS	The primary outcome measure was need for recovery .
METHODS	Secondary outcomes were work-related stress ( i.e. , exhaustion , detachment and relaxation ) , small breaks , physical activity ( i.e. , stair climbing , active commuting , sport activities , light/moderate/vigorous physical activity ) and sedentary behavior .
METHODS	Outcomes were measured by questionnaires at baseline , 6 and 12 months follow-up .
METHODS	Multilevel analyses were performed to investigate the effects of the three interventions .
RESULTS	In all intervention groups , a non-significant reduction was found in need for recovery .
RESULTS	In the combined intervention ( n = 92 ) , exhaustion and vigorous physical activities decreased significantly , and small breaks at work and active commuting increased significantly compared to the control group .
RESULTS	The social intervention ( n = 118 ) showed a significant reduction in exhaustion , sedentary behavior at work and a significant increase in small breaks at work and leisure activities .
RESULTS	In the physical intervention ( n = 96 ) , stair climbing at work and active commuting significantly increased , and sedentary behavior at work decreased significantly compared to the control group .
CONCLUSIONS	None of the interventions was effective in improving the need for recovery .
CONCLUSIONS	It is recommended to implement the social and physical intervention among a population with higher baseline values of need for recovery .
CONCLUSIONS	Furthermore , the intervention itself could be improved by increasing the intensity of the intervention ( for example weekly GMI-sessions ) , providing physical activity opportunities and exercise schemes , and by more drastic environment interventions ( restructuring entire department floor ) .
BACKGROUND	Nederlands Trial Register NTR2553 .

###24432674
OBJECTIVE	To observe the clinical effect on treatment of premature ovarian failure ( POF ) patients by Bushen Tiaojing Recipe ( BTR ) and hormone replacement therapy ( HRT ) .
METHODS	Totally 72 POF patients were randomly assigned to three groups by random digit table , i.e. , the Chinese medicine group , the Western medicine group , and the integrative medicine group , 24 in each group .
METHODS	Those in the Chinese medicine group took BTR .
METHODS	Those in the Western medicine group were treated by HRT .
METHODS	Those in the integrative medicine group were treated by BTR + HRT .
METHODS	All were treated for three courses and followed-up for 3 months after treatment .
METHODS	The clinical efficacy , integrals of clinical symptoms , and serum sex hormones levels [ follicular stimulating hormone ( FSH ) , estradiol ( E2 ) , luteinizing hormone ( LH ) ] were compared among the three groups before treatment , at the end of treatment , and 3 months after withdrawal .
RESULTS	( 1 ) The total effective rate was better in the integrative medicine group than in the Chinese medicine group and the Western medicine group ( P < 0.05 ) .
RESULTS	( 2 ) At the end of treatment , the integrals of clinical symptoms decreased in the 3 groups when compared with before treatment in the same group ( P < 0.05 , P < 0.01 ) .
RESULTS	The integrals of clinical symptoms were higher at 3 months after withdrawal than at the end of treatment in the Western medicine group ( P < 0.05 ) .
RESULTS	But there was no statistical difference in changes of integrals between the Chinese medicine group and the integrative medicine group ( P > 0.05 ) .
RESULTS	( 3 ) By the end of treatment serum E2 increased ( P < 0.01 ) , FSH and LH decreased ( P < 0.01 ) in the three groups , more significantly in the integrative medicine group and the Western medicine group ( P < 0.05 , P < 0.01 ) .
RESULTS	At 3 months after withdrawal serum E2 decreased , FSH and LH increased in the Western medicine group , showing statistical difference when compared with the other two groups ( P < 0.05 , P < 0.01 ) .
RESULTS	There was no statistical difference in changes of serum E2 , FSH , or LH between the Chinese medicine group and the integrative medicine group ( P > 0.05 ) .
CONCLUSIONS	BTR combined HRT had significant effect on treatment of POF , could significantly improve patients ' clinical symptoms , menstrual states , and serum sex hormones levels .
CONCLUSIONS	It had lower recurrence rate .
CONCLUSIONS	Patients suffered from less adverse reactions .

###24756515
OBJECTIVE	Benzodiazepines are considered first-line therapy for pediatric status epilepticus .
OBJECTIVE	Some studies suggest that lorazepam may be more effective or safer than diazepam , but lorazepam is not Food and Drug Administration approved for this indication .
OBJECTIVE	To test the hypothesis that lorazepam has better efficacy and safety than diazepam for treating pediatric status epilepticus .
METHODS	This double-blind , randomized clinical trial was conducted from March 1 , 2008 , to March 14 , 2012 .
METHODS	Patients aged 3 months to younger than 18 years with convulsive status epilepticus presenting to 1 of 11 US academic pediatric emergency departments were eligible .
METHODS	There were 273 patients ; 140 randomized to diazepam and 133 to lorazepam .
METHODS	Patients received either 0.2 mg/kg of diazepam or 0.1 mg/kg of lorazepam intravenously , with half this dose repeated at 5 minutes if necessary .
METHODS	If status epilepticus continued at 12 minutes , fosphenytoin was administered .
METHODS	The primary efficacy outcome was cessation of status epilepticus by 10 minutes without recurrence within 30 minutes .
METHODS	The primary safety outcome was the performance of assisted ventilation .
METHODS	Secondary outcomes included rates of seizure recurrence and sedation and times to cessation of status epilepticus and return to baseline mental status .
METHODS	Outcomes were measured 4 hours after study medication administration .
RESULTS	Cessation of status epilepticus for 10 minutes without recurrence within 30 minutes occurred in 101 of 140 ( 72.1 % ) in the diazepam group and 97 of 133 ( 72.9 % ) in the lorazepam group , with an absolute efficacy difference of 0.8 % ( 95 % CI , -11.4 % to 9.8 % ) .
RESULTS	Twenty-six patients in each group required assisted ventilation ( 16.0 % given diazepam and 17.6 % given lorazepam ; absolute risk difference , 1.6 % ; 95 % CI , -9.9 % to 6.8 % ) .
RESULTS	There were no statistically significant differences in secondary outcomes except that lorazepam patients were more likely to be sedated ( 66.9 % vs 50 % , respectively ; absolute risk difference , 16.9 % ; 95 % CI , 6.1 % to 27.7 % ) .
CONCLUSIONS	Among pediatric patients with convulsive status epilepticus , treatment with lorazepam did not result in improved efficacy or safety compared with diazepam .
CONCLUSIONS	These findings do not support the preferential use of lorazepam for this condition .
BACKGROUND	clinicaltrials.gov Identifier : NCT00621478 .

###24836309
BACKGROUND	Acetylcysteine has been suggested as a beneficial treatment for idiopathic pulmonary fibrosis , although data from placebo-controlled studies are lacking .
METHODS	In our initial double-blind , placebo-controlled trial , we randomly assigned patients who had idiopathic pulmonary fibrosis with mild-to-moderate impairment in pulmonary function to receive a three-drug regimen of prednisone , azathioprine , and acetylcysteine ; acetylcysteine alone ; or placebo .
METHODS	The study was interrupted owing to safety concerns associated with the three-drug regimen .
METHODS	The trial continued as a two-group study ( acetylcysteine vs. placebo ) without other changes ; 133 and 131 patients were enrolled in the acetylcysteine and placebo groups , respectively .
METHODS	The primary outcome was the change in forced vital capacity ( FVC ) over a 60-week period .
RESULTS	At 60 weeks , there was no significant difference in the change in FVC between the acetylcysteine group and the placebo group ( -0.18 liters and -0.19 liters , respectively ; P = 0.77 ) .
RESULTS	In addition , there were no significant differences between the acetylcysteine group and the placebo group in the rates of death ( 4.9 % vs. 2.5 % , P = 0.30 by the log-rank test ) or acute exacerbation ( 2.3 % in each group , P > 0.99 ) .
CONCLUSIONS	As compared with placebo , acetylcysteine offered no significant benefit with respect to the preservation of FVC in patients with idiopathic pulmonary fibrosis with mild-to-moderate impairment in lung function .
CONCLUSIONS	( Funded by the National Heart , Lung , and Blood Institute and others ; ClinicalTrials.gov number , NCT00650091 . )

###25216143
OBJECTIVE	The aim of this study was to evaluate marginal bone levels , with cone beam computed tomography , on the buccal and lingual aspects of implants placed with the implant-abutment interface ( IAI ) at different positions in relation to the alveolar crest .
METHODS	Thirty patients in need of single-tooth rehabilitation were randomly assigned to three groups based on the position of the IAI in relation to the buccal aspect of the alveolar crest at the time of implant placement .
METHODS	Patients in groups 0 , 1 , and 2 had their implants placed level with the buccal crest or 1 or 2 mm apical to the buccal aspect of the alveolar crest , respectively .
METHODS	The implants were restored with screw-retained single crowns after 4 months .
METHODS	Marginal bone levels on the buccal and lingual aspects of the implants were evaluated at 12 months after implant placement .
RESULTS	All groups of implants demonstrated significantly different crestal positions .
RESULTS	Group 2 implants maintained the greatest subcrestal position ( 1.33 0.86 mm ) compared to the implants of group 0 ( -0.04 0.18 mm ) and group 1 ( 0.34 0.44 mm ) .
RESULTS	There were no differences between groups in the level of the first bone-to-implant contact relative to the implant platform .
RESULTS	Implants of group 0 exhibited less buccal bone remodeling ( -0.08 0.25 mm ) compared to group 1 ( -0.65 0.45 mm ) and group 2 ( -0.85 0.75 mm ) implants .
RESULTS	For groups 1 and 2 implants , there was a significant negative correlation between buccal wall thickness following the osteotomy and the amount of buccal bone remodeling .
CONCLUSIONS	In this study , different responses were seen in the buccal and lingual peri-implant bone for implants with platform-switched Morse taper connections placed with the IAI at different locations in relation to the alveolar crest .

###24576096
OBJECTIVE	Evaluate antinociception , anesthesia , and recovery in llamas given tiletamine-zolazepam ( TZ ) with either morphine , xylazine , morphine and xylazine , or saline .
METHODS	Randomized crossover experimental study .
METHODS	Six healthy , adult intact male llamas .
METHODS	Llamas were given each of four treatments intramuscularly with a 1-week washout : TZ ( 2 mg kg ( -1 ) ) combined with either morphine ( 0.5 mg kg ( -1 ) ; M ) , xylazine ( 0.15 mg kg ( -1 ) ; X ) , morphine ( 0.5 mg kg ( -1 ) ) and xylazine ( 0.15 mg kg ( -1 ) ) ( MX ) , or saline ( C ) .
METHODS	Llamas breathed room air during the experiment .
METHODS	Characteristics of anesthesia , recovery , and selected cardiopulmonary variables were recorded .
METHODS	Antinociception was assessed by clamping a claw at 5-minute intervals .
METHODS	Data were analyzed using a mixed-model anova and Tukey-Kramer test , and are expressed as least squares mean SEM .
METHODS	Significance was set at p < 0.05 .
RESULTS	No llama in the control group demonstrated antinociception .
RESULTS	Antinociception was longest with treatment MX , followed by treatments X and M , respectively .
RESULTS	Heart rates in llamas given treatments X and MX were significantly lower than with other treatments .
RESULTS	The respiratory rate in llamas given treatment C was greater ( p < 0.05 ) than for all other treatments , however , the respiratory rate was not significantly different among treatments X , M and MX .
RESULTS	The PaO2 for llamas given MX remained < 60 mmHg throughout the 20 minute period of blood gas analysis .
RESULTS	Mean arterial blood pressure in llamas in treatment MX was less than for treatments M or C.
CONCLUSIONS	The combination of morphine ( 0.5 mg kg ( -1 ) ) and xylazine ( 0.15 mg kg ( -1 ) ) increased the duration of antinociception compared with xylazine alone , in TZ-anesthetized llamas .
CONCLUSIONS	Treatments X , M and MX were associated with hypoxemia ( PaO2 < 60 mmHg ) .

###24939906
BACKGROUND	Current oral rotavirus vaccines perform suboptimally in resource-poor settings .
BACKGROUND	We investigated the effect of an additional dose and later schedule on the immunogenicity of monovalent rotavirus vaccine ( RV1 ) in a developing country .
METHODS	Infants received RV1 at 6 and 10 , 10 and 14 , or 6 , 10 , and 14 weeks of age .
METHODS	The primary objective was to compare antirotavirus immunoglobulin A ( IgA ) seroconversion at 18 weeks in the 6/10/14 arm to the cumulative seroconversion ( highest result at 14 or 18 weeks ) in the 6/10 arm .
RESULTS	Overall , 480 ( 76.2 % ) of 630 randomized infants completed the trial per protocol .
RESULTS	Seroconversion in the 6/10/14 arm was 36.7 % ( 95 % CI , 29.8 , 44.2 ) compared to 36.1 % ( CI , 29.0 , 43.9 ) in the 6/10 arm , ( P = 1.0 ) ; the result from the 10/14 arm was 38.5 % ( CI , 31.2 , 46.3 ) .
RESULTS	Seroconversion in the 6/10 arm at 14 weeks ( post hoc ) was lower at 29.7 % ( CI , 23.1 , 37.3 ) .
CONCLUSIONS	In Pakistani infants , the immunogenicity of RV1 did not increase significantly with 3 doses at 6 , 10 , and 14 weeks compared to 2 doses at 6 and 10 weeks .
CONCLUSIONS	Additional strategies should be evaluated for improving rotavirus vaccine immunogenicity in high burden countries .

###24407920
OBJECTIVE	The cholesterol absorption inhibitor ezetimibe has been shown to ameliorate non-alcoholic fatty liver disease ( NAFLD ) pathology in a single-armed clinical study and in experimental animal models .
OBJECTIVE	In this study , we investigated the efficacy of ezetimibe on NAFLD pathology in an open-label randomised controlled clinical trial .
METHODS	We had planned to enrol 80 patients in the trial , as we had estimated that , with this sample size , the study would have 90 % power .
METHODS	The study intervention and enrolment were discontinued because of the higher proportion of adverse events ( significant elevation in HbA ( 1c ) ) in the ezetimibe group than in the control group .
METHODS	Thirty-two patients with NAFLD were enrolled and randomised ( allocation by computer program ) .
METHODS	Ezetimibe ( 10 mg/day ) was given to 17 patients with NAFLD for 6 months .
METHODS	The primary endpoint was change in serum aminotransferase level .
METHODS	Secondary outcomes were change in liver histology ( 12 control and 16 ezetimibe patients ) , insulin sensitivity including a hyperinsulinaemic-euglycaemic clamp study ( ten control and 13 ezetimibe patients ) and hepatic fatty acid composition ( six control and nine ezetimibe patients ) .
METHODS	Hepatic gene expression profiling was completed in 15 patients using an Affymetrix gene chip .
METHODS	Patients and the physician in charge knew to which group the patient had been allocated , but people carrying out measurements or examinations were blinded to group .
RESULTS	Serum total cholesterol was significantly decreased in the ezetimibe group .
RESULTS	The fibrosis stage and ballooning score were also significantly improved with ezetimibe treatment .
RESULTS	However , ezetimibe treatment significantly increased HbA1c and was associated with a significant increase in hepatic long-chain fatty acids .
RESULTS	Hepatic gene expression analysis showed coordinate downregulation of genes involved in skeletal muscle development and cell adhesion molecules in the ezetimibe treatment group , suggesting a suppression of stellate cell development into myofibroblasts .
RESULTS	Genes involved in the L-carnitine pathway were coordinately downregulated by ezetimibe treatment and those in the steroid metabolism pathway upregulated , suggestive of impaired oxidation of long-chain fatty acids .
CONCLUSIONS	Ezetimibe improved hepatic fibrosis but increased hepatic long-chain fatty acids and HbA1c in patients with NAFLD .
CONCLUSIONS	These findings shed light on previously unrecognised actions of ezetimibe that should be examined further in future studies .
BACKGROUND	University Hospital Medical Information Network ( UMIN ) Clinical Trials Registry UMIN000005250 .
BACKGROUND	The study was funded by grants-in-aid from the Ministry of Education , Culture , Sports , Science and Technology , Japan , and research grants from MSD .

###24640437
OBJECTIVE	To investigate whether the long term use of two dentifrices containing arginine , an insoluble calcium compound , and fluoride : ( 1 ) 1.5 % arginine and 1450 ppm F as sodium monofluorophosphate ( NaMFP ) in a dicalcium phosphate dihydrate ( dical ) base , and ( 2 ) 8.0 % arginine and 1450 ppm F as NaMFP in a calcium carbonate base , results in an increase in oral malodor potentially associated with increased ammonia production from breakdown of arginine , as compared to a commercially available fluoride dentifrice without arginine ( 1450 ppm F as NaMFP in a dical base ) , after 6 months of product use .
METHODS	A 6-month clinical study , with 119 subjects , was conducted in Chengdu , China , using a double blind , randomized , parallel , three-treatment design .
METHODS	A panel of four expert judges used a nine-point hedonic scale to evaluate breath odor using a protocol designed in concordance with the ADA Acceptance Program Guidelines for Product Used in the Management of Oral Malodor .
METHODS	After a baseline evaluation , study subjects who scored above the threshold value for unpleasant breath odor were stratified by score and randomized into one of three treatment groups .
METHODS	Subjects were provided with a soft-bristled manual toothbrush ( Colgate Classic Clean Toothbrush ) and brushed their teeth thoroughly in their regular and customary manner for 1 minute with their assigned dentifrice , twice daily .
METHODS	Before breath-odor evaluations , the subjects refrained from eating odorigenic foods and did not use dental hygiene procedures , breath mints , or mouth rinses for 48 hours and 12 hours , respectively .
RESULTS	There was no statistically significant difference in oral malodor levels among subjects using the three dentifrices after 1 , 3 and 6 months of product use .

###24918567
BACKGROUND	Recurrence rates of actinic keratosis ( AK ) lesions after cryosurgery are high , and this treatment does not address field cancerization .
BACKGROUND	We investigated the efficacy and safety of field treatment of AKs with ingenol mebutate gel following cryosurgery .
METHODS	In this phase 3 , randomized , double-blind , vehicle-controlled study ( NCT01541553 ) , patients 18 years with four to eight clinically typical , visible , discrete AKs within a contiguous 25-cm2 treatment area on the face or scalp underwent cryosurgery followed 3 weeks later by once-daily ingenol mebutate 0.015 % or vehicle gel for 3 consecutive days .
METHODS	Endpoints included complete clearance at week 11 and safety and efficacy over 12 months .
RESULTS	In 329 randomized patients , complete clearance rates were greater with ingenol mebutate than vehicle ( week 11 : 60.5 % vs 49.4 % ; P = .04 ; month 12 : 30.5 % vs 18.5 % ; P = .01 ) .
RESULTS	Fewer patients experienced the emergence of new lesions with ingenol mebutate than with vehicle ( 38.9 % vs 51.9 % ; P = .02 ) .
RESULTS	At month 12 , mean percentage reduction of AKs was higher with ingenol mebutate than with vehicle ( 68.2 % vs 54.1 % ; P = .002 ) .
RESULTS	The probability of remaining free of lesions was sustained longer with ingenol mebutate compared with vehicle gel : 78 % vs 68 % at 6 months ; 64 % vs 57 % at 9 months ; 55 % vs 40 % at month 12 , respectively .
RESULTS	Ingenol mebutate 0.015 % gel was well tolerated and no unexpected adverse events occurred ; all adverse events resolved within 2 weeks of starting treatment .
CONCLUSIONS	Field treatment with ingenol mebutate 0.015 % gel following cryosurgery significantly enhanced clearance of baseline lesions , and was well tolerated .
CONCLUSIONS	Furthermore , ingenol mebutate 0.015 % gel following cryosurgery reduced development of new lesions in the treated field .

###25615992
BACKGROUND	Lecturing has been traditionally used as the core teaching strategy in university education in all disciplines .
BACKGROUND	However , new research in education suggests that other formats such as game teaching could be more effective .
OBJECTIVE	To compare students ' performance , satisfaction and retention of knowledge between a Jeopardy! - style game format and a didactic lecture format in teaching the subject of models for organising patient care to fourth-year nursing students .
METHODS	A parallel-group randomised controlled trial was conducted .
METHODS	Participants were fourth-year nursing students who registered in the second semester of 2012-2013 and enrolled in the Nursing Management and Ethics in Nursing Course in the Community Health Department .
RESULTS	66 students completed the study ( 34 in the quiz game group and 32 in the lecture group ) .
RESULTS	Pre-test results showed no significant difference between the two groups in their achievement scores .
RESULTS	However , in the immediate achievement post-test and the retention test the students in the quiz group scored significantly better than those in the lecture group .
RESULTS	A satisfaction questionnaire showed that the game format was well liked and accepted by students as a more satisfying teaching method .
CONCLUSIONS	This study is the first of its kind in Jordan to explore the effectiveness of this particular game format versus the lecture format .
CONCLUSIONS	RESULTS suggest that the game format was well liked and accepted by students as a more satisfying teaching method .
CONCLUSIONS	Additionally , it appeared to be a better method of education as it promoted greater information retention .

###24708617
BACKGROUND	Obesity and stress are among the most common lifestyle-related health problems .
BACKGROUND	Most of the current disease prevention and management models are not satisfactorily cost-effective and hardly reach those who need them the most .
BACKGROUND	Therefore , novel evidence-based controlled interventions are necessary to evaluate models for prevention and treatment based on self-management .
BACKGROUND	This randomized controlled trial examines the effectiveness , applicability , and acceptability of different lifestyle interventions with individuals having symptoms of metabolic syndrome and psychological distress .
BACKGROUND	The offered interventions are based on cognitive behavioral approaches , and are designed for enhancing general well-being and supporting personalized lifestyle changes .
METHODS	339 obese individuals reporting stress symptoms were recruited and randomized to either ( 1 ) a minimal contact web-guided Cognitive Behavioral Therapy-based ( CBT ) intervention including an approach of health assessment and coaching methods , ( 2 ) a mobile-guided intervention comprising of mindfulness , acceptance and value-based exercises , ( 3 ) a face-to-face group intervention using mindfulness , acceptance and value-based approach , or ( 4 ) a control group .
METHODS	The participants were measured three times during the study ( pre = week 0 , post = week 10 , and follow-up = week 36 ) .
METHODS	Psychological well-being , lifestyles and habits , eating behaviors , and user experiences were measured using online surveys .
METHODS	Laboratory measurements for physical well-being and general health were performed including e.g. liver function , thyroid glands , kidney function , blood lipids and glucose levels and body composition analysis .
METHODS	In addition , a 3-day ambulatory heart rate and 7-day movement data were collected for analyzing stress , recovery , physical activity , and sleep patterns .
METHODS	Food intake data were collected with a 48 - hour diet recall interview via telephone .
METHODS	Differences in the effects of the interventions would be examined using multiple-group modeling techniques , and effect-size calculations .
CONCLUSIONS	This study will provide additional knowledge about the effects of three low intensity interventions for improving general well-being among individuals with obesity and stress symptoms .
CONCLUSIONS	The study will show effects of two technology guided self-help interventions as well as effect of an acceptance and value-based brief group intervention .
CONCLUSIONS	Those who might benefit from the aforesaid interventions will increase knowledge base to better understand what mechanisms facilitate effects of the interventions .
BACKGROUND	Current Clinical Trials NCT01738256 , Registered 17 August , 2012 .

###25456576
BACKGROUND	Understanding the intracellular mechanisms induced by remote ischemic preconditioning ( RIPC ) in the human left ventricle opens new possibilities for development of pharmacological cardioprotection against ischemia and reperfusion injury .
BACKGROUND	In this study we investigated the effects of RIPC on mitochondrial function , activation of pro-survival protein kinase Akt and microRNA expression in left ventricular biopsies from patients undergoing coronary artery bypass surgery ( CABG ) .
METHODS	Sixty patients were randomized to control ( n = 30 ) or RIPC ( n = 30 ) .
METHODS	A blood pressure cuff was applied to the arm of all patients preoperatively .
METHODS	The cuff remained deflated in control group , whereas RIPC was performed by 3 cycles of cuff inflation to 200 mm Hg for 5 min , separated by 5 min deflation intervals .
METHODS	Left ventricular biopsies were obtained before and 15 min after aortic declamping .
METHODS	The primary outcome was mitochondrial respiration measured in situ .
METHODS	Secondary outcomes were activation of protein kinase Akt , assessed by western immunoblotting , and expression of microRNAs assessed by array and real-time polymerase chain reaction .
RESULTS	Mitochondrial respiration was preserved during surgery in patients receiving RIPC ( +0.2 mol O2/min/g , p = 0.69 ) , and reduced by 15 % in controls ( -1.5 mol O2/min/g , p = 0.02 ) .
RESULTS	Furthermore , RIPC activated protein kinase Akt before aortic clamping ( difference from control +43.3 % , p = 0.04 ) , followed by increased phosphorylation of Akt substrates at reperfusion ( +26.8 % , p < 0.01 ) .
RESULTS	No differences were observed in microRNA expression .
CONCLUSIONS	RIPC preserves mitochondrial function and activates pro-survival protein kinase Akt in left ventricle of patients undergoing CABG .
CONCLUSIONS	Modulation of mitochondrial function and Akt activation should be further explored as cardioprotective drug targets .
BACKGROUND	http://www.clinicaltrials.gov , unique identifier : NCT01308138 .

###25015027
OBJECTIVE	In the management of attention-deficit hyperactivity disorder ( ADHD ) in adults it is important to recognize that individual patients respond to a wide range of methylphenidate doses .
OBJECTIVE	Studies with methylphenidate modified release long acting ( MPH-LA ) in children have reported the need for treatment optimization for improved outcomes .
OBJECTIVE	We report the results from a post hoc analysis of a 5-week dose optimization phase from a large randomized , placebo-controlled , multicenter 40-week study ( 9-week double-blind dose confirmation phase , 5-week open-label dose optimization phase , and 26-week double-blind maintenance of effect phase ) .
METHODS	Patients entering the open-label dose optimization phase initiated treatment with MPH-LA 20 mg/day ; up/down titrated to their optimal dose ( at which there was balance between control of symptoms and side effects ) of 40 , 60 , or 80 mg/day in increments of 20 mg/week by week 12 or 13 .
METHODS	Safety was assessed by monitoring the adverse events ( AEs ) and serious AEs .
METHODS	Efficacy was assessed by the Diagnostic and Statistical Manual of Mental Disorders , fourth edition , Attention-Deficit Hyperactivity Disorder Rating Scale ( DSM-IV ADHD RS ) and Sheehan Disability Scale ( SDS ) total scores .
RESULTS	At the end of the dose confirmation phase , similar numbers of patients were treated optimally with each of the 40 , 60 , and 80 mg/day doses ( 152 , 177 , and 160 , respectively ) for MPH-LA .
RESULTS	Mean improvement from baseline in the dose confirmation phase in total scores of DSM-IV ADHD RS and SDS were 23.5 9.90 and 9.7 7.36 , respectively .
CONCLUSIONS	Dose optimization with MPH-LA ( 40 , 60 , or 80 mg/day ) improved treatment outcomes and was well-tolerated in adult ADHD patients .

###24888911
OBJECTIVE	The aim of this study was to compare the efficacy of combined intracervical Foley catheter and low-dose vaginal misoprostol with low-dose vaginal misoprostol alone for induction of labor .
METHODS	This prospective non-blinded randomized controlled trial was conducted over a 2-year period in 126 pregnant women planned for induction of labor at a tertiary care centre .
METHODS	Women at 28 gestational weeks with a singleton fetus in cephalic presentation , intact membranes and a Bishop score of 4 were randomized for labor induction with either a combination of Foley catheter and misoprostol or only misoprostol .
METHODS	The primary outcome variable was the induction-to-delivery interval between the two groups .
METHODS	The secondary outcome variables included rate of vaginal deliveries , uterine hyperstimulation , cesarean section rate , Apgar scores at 1 and 5 min , neonatal intensive care unit admissions and chorioamnionitis .
RESULTS	The mean induction-to-delivery interval and rate of vaginal deliveries were not significantly different between the groups ( 26.52 h in the combination group and 27.64 h in the misoprostol group , P = 0.65 ; 65.07 % and 65.07 % , respectively , P = 0.9 ) .
RESULTS	Uterine hyperstimulation and meconium-stained liquor were significantly more prevalent in the misoprostol group ( P = 0.001 ) .
RESULTS	Neonatal outcomes did not differ significantly between the groups .
CONCLUSIONS	The addition of Foley catheter to misoprostol did not cause any statistically significant benefit in reducing the induction-to-delivery time .
CONCLUSIONS	However , it reduced the incidence of uterine hyperstimulation and meconium-stained liquor .

###25321621
BACKGROUND	The aim of this study was to investigate clinical efficacy and safety of Remifemin on peri-menopausal symptoms in endometriosis patients with a post-operative GnRH-a therapy .
METHODS	We treated 116 women who had endometriosis with either Remifemin ( n = 56 ) 20 mg bid po or Tibolone ( n = 60 ) 2.5 mg qd po for 12 weeks after GnRH-a injection .
METHODS	The efficacy was evaluated by Kupperman menopausal index ( KMI ) , and hot flash/sweating scores .
METHODS	The safety parameters such as liver and renal functions , lipid profile , endometrial thickness , and serum sex hormone level , as well as the incidence of adverse events were recorded .
RESULTS	( 1 ) After GnRH-a therapy , KMI and hot flash/sweating scores in both groups increased significantly ( P < 0.05 ) but we found no significant difference for KMI ( 2.871.40 for Remifemin and 2.701.26 for Tibolone ) and hot flash/sweating scores ( 0.941.72 for Remifemin and 1.061.78 for Tibolone ) between the 2 groups ( P > 0.05 ) .
RESULTS	( 2 ) No statistical change was observed in liver or renal functions and lipid profile in both groups before and after the treatment ( P > 0.05 ) .
RESULTS	The post-therapeutic serum FSH , LH , and E2 level and endometrial thickness decreased remarkably in both groups ( P < 0.05 ) .
RESULTS	E2 level in the Remifemin group was obviously lower than that in the Tibolone group ( P < 0.05 ) , and FSH and LH levels were strongly higher ( P < 0.05 ) .
RESULTS	No significant difference in thickness were found in either group ( P > 0.05 ) .
RESULTS	The Remifemin group had far fewer adverse events than the Tibolone group ( P < 0.05 ) .
CONCLUSIONS	Compared with Tibolone , Remifemin had a similar clinical efficacy and was safer for the peri-menopausal symptoms induced by GnRH-a in endometriosis patients .

###24877181
OBJECTIVE	To assess the dose proportionality of azacitidine pharmacokinetics ( PK ) after single subcutaneous ( SC ) doses of 25-100 mg/m2 , and determine the effect of renal impairment on PK after single and multiple 75 mg/m2 SC azacitidine doses .
METHODS	Multicenter , phase I , open-label , parallel group study .
METHODS	Community clinics and major academic centers .
METHODS	Twenty-seven patients with solid or hematologic malignancies .
METHODS	Part 1 evaluated azacitidine dose proportionality in patients with normal renal function randomized to single 25 , 50 , 75 , or 100 mg/m2 SC doses .
METHODS	The 75 mg/m2 dosing group received 4 additional days of SC azacitidine .
METHODS	In Part 2 , patients with severe renal impairment ( creatinine clearance < 30 ml/min/1 .73 m2 Cockcroft-Gault adjusted ) received azacitidine 75 mg/m2 for 5 consecutive days .
RESULTS	PK parameters were determined using noncompartmental methods .
RESULTS	In patients with normal renal function ( n = 21 ) , azacitidine area under the plasma-time curve ( AUC0 - ) and maximum observed plasma concentration ( Cmax ) were dose proportional within the 25-100 mg/m2 range .
RESULTS	Concentration versus time profiles after single and multiple azacitidine 75 mg/m2 doses were similar in shape for patients with normal ( n = 6 ) or impaired renal function ( n = 6 ) , with higher mean concentrations in the latter group .
RESULTS	Higher mean exposures ( AUC0 - and Cmax ) in renally impaired patients were observed ; however , individual exposure values were , with few exceptions , within the same range in both groups .
RESULTS	No drug accumulation after multiple doses was observed in either group .
RESULTS	Terminal half-life and time to maximum plasma concentration were comparable between groups .
RESULTS	Azacitidine tolerability was similar in patients with normal or impaired renal function .
CONCLUSIONS	Azacitidine is dose proportional over the 25-100 mg/m2 dosing range .
CONCLUSIONS	Overall , renal impairment had no important effect on azacitidine PK .
CONCLUSIONS	Therefore , no initial azacitidine dose adjustment in patients with renal impairment is required .

###24411797
OBJECTIVE	The purpose of this study was to determine ( a ) whether among sober ( blood alcohol concentration [ BAC ] = .00 % ) drivers , being drug positive increases the drivers ' risk of being killed in a fatal crash ; ( b ) whether among drinking ( BAC > .00 % ) drivers , being drug positive increases the drivers ' risk of being killed in a fatal crash ; and ( c ) whether alcohol and other drugs interact in increasing crash risk .
METHODS	We compared BACs for the 2006 , 2007 , and 2008 crash cases drawn from the U.S. Fatality Analysis Reporting System ( FARS ) with control drug and blood alcohol data from participants in the 2007 U.S. National Roadside Survey .
METHODS	Only FARS drivers from states with drug information on 80 % or more of the drivers who also participated in the 2007 National Roadside Survey were selected .
RESULTS	For both sober and drinking drivers , being positive for a drug was found to increase the risk of being fatally injured .
RESULTS	When the drug-positive variable was separated into marijuana and other drugs , only the latter was found to contribute significantly to crash risk .
RESULTS	In all cases , the contribution of drugs other than alcohol to crash risk was significantly lower than that produced by alcohol .
CONCLUSIONS	Although overall , drugs contribute to crash risk regardless of the presence of alcohol , such a contribution is much lower than that by alcohol .
CONCLUSIONS	The lower contribution of drugs other than alcohol to crash risk relative to that of alcohol suggests caution in focusing too much on drugged driving , potentially diverting scarce resources from curbing drunk driving .

###25855918
OBJECTIVE	Patients with head and neck cancer undergoing surgery have a high occurrence of postoperative complications .
OBJECTIVE	The aim of our study was to investigate whether postoperative nutrition of head and neck cancer patients , using an enhanced enteral formula with three different doses of arginine could improve nutritional variables as well as clinical outcome , depending of arginine dose .
METHODS	A population of 84 patients with oral and laryngeal cancer was enrolled .
METHODS	At surgery patients were randomly assigned to three different treatment groups , each one containing at less 28 patients .
METHODS	Group I ( 28 patients ) received an enteral diet supplements with a low physiological dose of arginine ( 5.7 g per day ) , group II ( 28 patients ) received an isocaloric , isonitrogenous enteral formula with a medium dose of arginine ( 12.3 g per day ) and group III ( 28 patients ) received an isocaloric , isonitrogenous enteral formula with a high dose of arginine ( 18.9 g per day ) .
RESULTS	The length of postoperative stay had a trend to be better with high dose of arginine received ( 31.9 17.2 days in group I vs 27.8 15.2 days in group II vs 24.8 18.3 days in group III : p = 0.034 ) .
RESULTS	No differences were detected in postoperative infections complications and diarrhea .
RESULTS	Fistula was less frequent in groups II and III than I ( 10.7 % group I vs 3.6 % group II vs 3.6 % group III : p = 0.033 ) , The length of postoperative stay had a trend to be better with high dose of arginine received ( 31.9 17.2 days in group I vs 27.8 15.2 days in group II vs 24.8 18.3 days in group III : p = 0.034 ) .
CONCLUSIONS	Our results suggest that these patients could benefit from a high dose of arginine enhanced enteral formula to decrease length of hospital stay and fistula wound complications .

###24491077
OBJECTIVE	Changes in adolescent interpersonal behavior before and after an acute course of psychotherapy were investigated as outcomes and mediators of remission status in a previously described treatment study of depressed adolescents .
OBJECTIVE	Maternal depressive symptoms were examined as moderators of the association between psychotherapy condition and changes in adolescents ' interpersonal behavior .
METHODS	Adolescents ( n = 63 , mean age = 15.6 years , 77.8 % female , 84.1 % White ) engaged in videotaped interactions with their mothers before randomization to cognitive behavior therapy ( CBT ) , systemic behavior family therapy ( SBFT ) , or nondirective supportive therapy ( NST ) and after 12-16 weeks of treatment .
METHODS	Adolescent involvement , problem solving , and dyadic conflict were examined .
RESULTS	Improvements in adolescent problem solving were significantly associated with CBT and SBFT .
RESULTS	Maternal depressive symptoms moderated the effect of CBT , but not SBFT , on adolescents ' problem solving ; adolescents experienced increases in problem solving only when their mothers had low or moderate levels of depressive symptoms .
RESULTS	Improvements in adolescents ' problem solving were associated with higher rates of remission across treatment conditions , but there were no significant indirect effects of SBFT on remission status through problem solving .
RESULTS	Exploratory analyses revealed a significant indirect effect of CBT on remission status through changes in adolescent problem solving , but only when maternal depressive symptoms at study entry were low .
CONCLUSIONS	Findings provide preliminary support for problem solving as an active treatment component of structured psychotherapies for depressed adolescents and suggest one pathway by which maternal depression may disrupt treatment efficacy for depressed adolescents treated with CBT .

###24261985
BACKGROUND	A high prevalence of low back pain has persisted over the years despite extensive primary prevention initiatives among nurses ' aides .
BACKGROUND	Many single-faceted interventions addressing just one aspect of low back pain have been carried out at workplaces , but with low success rate .
BACKGROUND	This may be due to the multi-factorial origin of low back pain .
BACKGROUND	Participatory ergonomics , cognitive behavioral training and physical training have previously shown promising effects on prevention and rehabilitation of low back pain .
BACKGROUND	Therefore , the main aim of this study is to examine whether a multi-faceted workplace intervention consisting of participatory ergonomics , physical training and cognitive behavioral training can prevent low back pain and its consequences among nurses ' aides .
BACKGROUND	External resources for the participating workplace and a strong commitment from the management and the organization support the intervention .
METHODS	To overcome implementation barriers within usual randomized controlled trial designed workplace interventions , this study uses a stepped-wedge cluster-randomized controlled trial design with 4 groups .
METHODS	The intervention is delivered to the groups at random along four successive time periods three months apart .
METHODS	The intervention lasts three months and integrates participatory ergonomics , physical training and cognitive behavioral training tailored to the target group .
METHODS	Local physiotherapists and occupational therapists conduct the intervention after having received standardized training .
METHODS	Primary outcomes are low back pain and its consequences measured monthly by text messages up to three months after initiation of the intervention .
CONCLUSIONS	Intervention effectiveness trials for preventing low back pain and its consequences in workplaces with physically demanding work are few , primarily single-faceted , with strict adherence to a traditional randomized controlled trial design that may hamper implementation and compliance , and have mostly been unsuccessful .
CONCLUSIONS	By using a stepped wedge design , and obtain high management commitment and support we intend to improve implementation and aim to establish the effectiveness of a multi-faceted intervention to prevent low back pain .
CONCLUSIONS	This study will potentially provide knowledge of prevention of low back pain and its consequences among nurses ' aides .
CONCLUSIONS	Results are expected to be published in 2015-2016 .
BACKGROUND	The study is registered as ISRCTN78113519 .

###24884770
BACKGROUND	Evidence is accumulating that , similar to other ventral hernias , umbilical and epigastric hernias must be mesh repaired .
BACKGROUND	The difficulties involved in mesh placement and in mesh-related complications could be the reason many small abdominal hernias are still primary closed .
BACKGROUND	In laparoscopic repair , a mesh is placed intraperitoneally , while the most common procedure is open surgery is pre-peritoneal mesh placement .
BACKGROUND	A recently developed alternative method is the so-called patch repair , in this approach a mesh can be placed intraperitoneally through open surgery .
BACKGROUND	In theory , such patches are particularly suitable for small hernias due to a reduction in the required dissection .
BACKGROUND	This simple procedure is described in several studies .
BACKGROUND	It is still unclear whether this new approach is associated with an equal risk of recurrence and complications compared with pre-peritoneal meshes .
BACKGROUND	The material of the patch is in direct contact with intra-abdominal organs , it is unknown if this leads to more complications .
BACKGROUND	On the other hand , the smaller dissection in the pre-peritoneal plane may lead to a reduction in wound complications .
METHODS	346 patients suffering from an umbilical or epigastric hernia will be included in a multi-centre patient-blinded trial , comparing mesh repair with patch repair .
METHODS	Randomisation will take place for the two operation techniques .
METHODS	The two devices investigated are a flat pre-peritoneal mesh and a Proceed Ventral Patch .
METHODS	Stratification will occur per centre .
METHODS	Post-operative evaluation will take place after 1 , 3 , 12 and 24 months .
METHODS	The number of complications requiring treatment is the primary endpoint .
METHODS	Secondary endpoints are Verbal Descriptor Scale ( VDS ) pain score and VDS cosmetic score , operation duration , recurrence and costs .
METHODS	An intention to treat analysis will be performed .
CONCLUSIONS	This trial is one of the first in its kind , to compare different mesh devices in a randomized controlled setting .
CONCLUSIONS	The results will help to evaluate mesh repair for epigastric an umbilical hernia , and find a surgical method that minimizes the complication rate .
BACKGROUND	Netherlands Trail Registration ( NTR ) www.trialregister.nl 2010 NTR2514 NL33995 .060.10 .

###24915013
OBJECTIVE	The aim of this study was to map the sensitivity of the marginal and other conjunctival regions and to investigate changes in the sensitivity of these regions when determined in the morning and evening .
METHODS	Thirty-five healthy , noncontact lens wearers ( 20 female , 15 male ; age 27.7 7.3 years ) were enrolled .
METHODS	Mechanical sensitivity was measured at 8 locations on the ocular surface and adnexa ( cornea , marginal , bulbar , and tarsal conjunctiva ) using a Cochet-Bonnet esthesiometer ( 0.12-mm diameter filament ) .
METHODS	A subgroup of 11 subjects ( 6 female , 5 male ; age 28.9 9.9 years ) returned after 12 hours when this protocol was repeated .
RESULTS	The cornea was found to be the most sensitive region ( all P < 0.001 ) .
RESULTS	The marginal conjunctiva showed greater sensitivity than did the bulbar and tarsal conjunctiva ( all P < 0.001 ) .
RESULTS	The temporal marginal conjunctiva was more sensitive than the central marginal conjunctiva ( all P < 0.05 ) .
RESULTS	No difference in marginal conjunctival sensitivity was found between upper and lower eyelids ( all P > 0.05 ) .
RESULTS	The upper tarsal conjunctiva was more sensitive than the lower tarsal conjunctiva ( P = 0.04 ) .
RESULTS	There was no significant difference in the sensitivity determined in the morning and the evening for any of the locations investigated ( Bonferroni adjusted , P > 0.006 ) .
CONCLUSIONS	This work has demonstrated that the marginal conjunctiva was the most sensitive of all the conjunctival regions and that this does not alter over the course of the day .

###25074397
OBJECTIVE	To compare 7 weeks of supervised physical rehabilitation with or without progressive strength training ( PST ) commenced early after fast-track total knee arthroplasty ( TKA ) on functional performance .
METHODS	In total , 82 patients with a unilateral primary TKA were randomized to 2 different interventions : 7 weeks of supervised physical rehabilitation with PST ( PST group ) and without PST ( CON group ) commenced early after fast-track TKA .
METHODS	The primary outcome was the maximal distance walked in 6 minutes ( 6-minute walk test ) .
METHODS	Secondary outcomes were lower extremity strength and power , knee joint effusion and range of motion , knee pain , and self-reported disability and quality of life .
METHODS	All outcome measures were assessed before TKA ( baseline ) and 4 , 8 , and 26 weeks after TKA .
RESULTS	There was no statistically significant difference between the PST and CON groups in the change score from baseline to the 8-week postoperative assessment ( primary end point ) for the 6-minute walk test with unadjusted baseline scores ( mean difference between groups : -11.3 meters [ 95 % confidence interval -45.4 , 22.7 ] ; analysis of variance P = 0.51 ) .
RESULTS	There were no statistically significant or clinically meaningful differences between groups in change scores from baseline to any other time point for all secondary outcomes .
RESULTS	The secondary outcome knee extension strength did not reach the level recorded before surgery in both groups .
CONCLUSIONS	Seven weeks of supervised physical rehabilitation with PST was not superior to 7 weeks of supervised physical rehabilitation without PST in improving functional performance , measured as the maximal walking distance in 6 minutes , at the primary end point 8 weeks after fast-track TKA .

###25590930
BACKGROUND	Effective interventions to improve medication adherence are usually complex and expensive .
OBJECTIVE	To assess the impact of a low-cost intervention designed to improve medication adherence and clinical outcomes in post-discharge patients with CVD .
METHODS	A pilot RCT was conducted at a teaching hospital .
METHODS	Intervention was based on the four-item Morisky Medication Adherence Scale ( MMAS-4 ) .
METHODS	The primary outcome measure was medication adherence assessed using the eight-item MMAS at baseline , at 1 month post hospital discharge and re-assessed 1 year after hospital discharge .
METHODS	Other outcomes included readmission and mortality rates .
RESULTS	61 patients were randomized to intervention ( n = 30 ) and control ( n = 31 ) groups .
RESULTS	The mean age of the patients was 61 years ( SD 12.73 ) , 52.5 % were males , and 57.4 % were married or living with a partner .
RESULTS	Mean number of prescribed medications per patient was 4.5 ( SD 3.3 ) .
RESULTS	Medication adherence was correlated to intervention ( p = 0.04 ) and after 1 month , 48.4 % of patients in the control group and 83.3 % in the intervention group were considered adherent .
RESULTS	However , this difference decreased after 1 year , when adherence was 34.8 % and 60.9 % , respectively .
RESULTS	Readmission and mortality rates were related to low adherence in both groups .
CONCLUSIONS	The intervention based on a validated patient self-report instrument for assessing adherence is a potentially effective method to improve adherent behavior and can be successfully used as a tool to guide adherence counseling in the clinical visit .
CONCLUSIONS	However , a larger study is required to assess the real impact of intervention on these outcomes .

###24453485
BACKGROUND	This study investigated the clinical efficacy of electroacupuncture ( EA ) in inhibiting upper-extremity spasticity in chronic stroke patients , and also in mapping a unique preliminary acupoint-selection protocol .
METHODS	Fifteen patients were divided into two groups : patients in the control group ( n = 6 ) received minimal acupuncture ( MA ) , and those in the experimental group ( n = 9 ) received EA .
METHODS	Four acupoints , which include Neiguan ( PC6 ) , Shaohai ( HT3 ) , Zeqian ( Ex-UE , A32 ) , and Shounizhu ( EX-UE ) , were treated near the motor points of the muscles for elbow flexion , forearm pronation , and finger flexion .
METHODS	Both groups were treated for twelve sessions , 20 minutes per session , for 6 weeks ( two sessions per week ) .
METHODS	The outcome measures in this study included angle of muscle reaction ( R1 ) , passive range of motion ( R2 ) , and dynamic component ( R2-R1 ) .
RESULTS	In the experimental group , the R2-R1 of the elbow joint was significantly decreased at 1 ( P = 0.0079 ) , 3 ( P = 0.0013 ) , and 6 weeks ( P = 0.0149 ) after treatment compared with pretreatment levels ( P < 0.05 ) .
RESULTS	The between-group difference in the R2-R1 of the elbow joint after the 6-week treatment was statistically significant .
CONCLUSIONS	Combining the 6-week EA and standard rehabilitation treatment reduced the spasticity of the elbow for chronic stroke survivors .
CONCLUSIONS	However , no significant effect was observed in the spasticity of the wrist joints .
CONCLUSIONS	The choice of acupoints and the frequency of EA have to be taken into account to achieve a positive treatment effect .
CONCLUSIONS	The correlation between acupoints and motor points provides a model of acupoint selection to improve spasticity .

###24404797
BACKGROUND	The goal of this study is to determine whether bronchodilator ( BD ) response can be used as a reliable measure of asthma control by analyzing the effects of a short course of oral corticosteroids ( OC ) or placebo ( P ) on spirometry , sputum cytology and BD response in controlled asthma patients scoring less than 1.5 on the ACQ5 .
METHODS	Seventy patients with moderate to severe asthma who were undergoing combination therapy and were considered to be controlled based on ACQ5 scores , but who exhibited persistent positive BD response , were randomly assigned to two groups , one receiving OC and the other P. Patients were evaluated before and after 2 weeks of treatment .
METHODS	Intervention response ( comparison of FEV ( 1 ) before and after OC or P treatment ) was used as a measure of intervention efficacy , with values equal to or greater than 200mL considered positive .
RESULTS	Patients who received OC showed significant improvement in FEV ( 1 ) , and no longer exhibited a positive BD response .
RESULTS	Those in the P group showed no change .
RESULTS	In addition , sputum eosinophil counts significantly decreased in the OC group .
CONCLUSIONS	BD response can be used as a reliable measure of asthma control .
CONCLUSIONS	This study suggests that ACQ5 scores alone are not sufficient to fully assess asthma control , and that BD response should be included as an essential measurement in any algorithm of asthma control evaluation .

###24513129
BACKGROUND	Previous research has demonstrated significant relationships between peri-shock pause and survival to discharge from out-of-hospital shockable cardiac arrest ( OHCA ) .
OBJECTIVE	To determine the impact of peri-shock pause on survival from OHCA during the ROC PRIMED randomized controlled trial .
METHODS	We included patients in the ROC PRIMED trial who suffered OHCA between June 2007 and November 2009 , presented with a shockable rhythm and had CPR process data for at least one shock .
METHODS	We used multivariable logistic regression to determine the association between peri-shock pause duration and survival to hospital discharge .
RESULTS	Among 2006 patients studied , the median ( IQR ) shock pause duration was : pre-shock pause 15s ( 8 , 22 ) ; post-shock pause 6s ( 4 , 9 ) ; and peri-shock pause 22.0 s ( 14 , 31 ) .
RESULTS	After adjusting for Utstein predictors of survival as well as CPR quality measures , the odds of survival to hospital discharge were significantly higher for patients with pre-shock pause < 10s ( OR : 1.52 , 95 % CI : 1.09 , 2.11 ) and peri-shock pause < 20s ( OR : 1.82 , 95 % CI : 1.17 , 2.85 ) when compared to patients with pre-shock pause 20s and peri-shock pause 40s .
RESULTS	Post-shock pause was not significantly associated with survival to hospital discharge .
RESULTS	Results for neurologically intact survival ( Modified Rankin Score 3 ) were similar to our primary outcome .
CONCLUSIONS	In patients with cardiac arrest presenting in a shockable rhythm during the ROC PRIMED trial , shorter pre - and peri-shock pauses were significantly associated with higher odds of survival .
CONCLUSIONS	Future cardiopulmonary education and technology should focus on minimizing all peri-shock pauses .

###24418055
BACKGROUND	In this study we assessed increased cortisol in Alzheimer 's disease ( AD ) patients .
BACKGROUND	The selective 11 -- hydroxysteroid dehydrogenase type 1 ( HSD-1 ) inhibitor ABT-384 blocked regeneration of active cortisol and this tests the hypothesis that intracellular hypercortisolism contributes to cognitive impairment .
METHODS	In this double-blind , placebo - and active-controlled phase II study we examine the efficacy and safety of ABT-384 given 10 mg or 50 mg once daily , donepezil 10 mg once daily , or placebo for 12 weeks in subjects with mild-to-moderate AD .
METHODS	The primary efficacy end point was the change from baseline to final evaluation on the 13-item Alzheimer 's Disease Assessment Scale-Cognitive subscale ( ADAS-Cog ) total score .
RESULTS	The study was terminated for futility after randomization of 267 subjects .
RESULTS	ABT-384 did not improve ADAS-Cog scores or any secondary end point ; however , donepezil significantly improved both cognition and functional end points .
RESULTS	Overall incidence of adverse events was similar among treatment groups .
CONCLUSIONS	ABT-384 , when tested at doses associated with complete brain HSD-1 inhibition , did not produce symptomatic improvement in AD .

###25026767
BACKGROUND	Medical health care centres should aim at the application of a two-dimensional concept of quality -- technical quality and functional quality .
BACKGROUND	Technical quality means the compliance with norms and technical requirements which apply to medical services that are provided to patients .
BACKGROUND	This concerns medical standards , technology and the competence of medical staff .
BACKGROUND	Functional quality , which means the subjective estimate of patients , is an additional benefit for the patient and it becomes the best competitive advantage in conditions of comparable technical levels of provided medical services .
BACKGROUND	The patient will be satisfied with medical services if these elements are balanced .
BACKGROUND	The aim of the study was the evaluation of the quality of functional services in a specialist outpatient clinic in the Szczecin area by patients .
METHODS	200 randomly-chosen patients of specialist outpatient clinics in Szczecin were asked to estimate the functional quality of services in specialist outpatient clinics .
METHODS	A questionnaire was used .
METHODS	The results were subjected to statistical analysis .
RESULTS	Most of the patients -- 51.3 % had confidence in their physician .
RESULTS	52.34 % of the patients claimed that their doctor was not interested in their problems .
RESULTS	Almost half of the respondents -- 47.92 % stated that there was no telephone contact with their doctor .
CONCLUSIONS	It is necessary to educate future physicians in problems of interpersonal communication .

###25773554
BACKGROUND	Phase 3 randomized trials have shown that maintenance rituximab ( MR ) therapy or radioimmunotherapy ( RIT ) consolidation following frontline therapy can improve progression-free survival for patients with follicular lymphoma ( FL ) , but the cost-effectiveness of these approaches with respect to observation has not been examined using a common modeling framework .
OBJECTIVE	To evaluate and compare the economic impact of MR and RIT consolidation versus observation , respectively , following the first-line induction therapy for patients with advanced-stage FL .
METHODS	We developed Markov models to estimate patients ' lifetime costs , quality-adjusted life-years ( QALYs ) , and life-years ( LYs ) after MR , RIT , and observation following frontline FL treatment from the US payer 's perspective .
METHODS	Progression risks , adverse event probabilities , costs , and utilities were estimated from clinical data of Primary RItuximab and MAintenance ( PRIMA ) trial , Eastern Cooperative Oncology Group ( ECOG ) trial ( for MR ) , and First-line Indolent Trial ( for RIT ) and the published literature .
METHODS	We evaluated the incremental cost-effectiveness ratio for direct comparisons between MR/RIT and observation .
METHODS	Model robustness was addressed by one-way and probabilistic sensitivity analyses .
RESULTS	Compared with observation , MR provided an additional 1.089 QALYs ( 1.099 LYs ) and 1.399 QALYs ( 1.391 LYs ) on the basis of the PRIMA trial and the ECOG trial , respectively , and RIT provided an additional 1.026 QALYs ( 1.034 LYs ) .
RESULTS	The incremental cost per QALY gained was $ 40,335 ( PRIMA ) or $ 37,412 ( ECOG ) for MR and $ 40,851 for RIT .
RESULTS	MR and RIT had comparable incremental QALYs before first progression , whereas RIT had higher incremental costs of adverse events due to higher incidences of cytopenias .
CONCLUSIONS	MR and RIT following frontline FL therapy demonstrated favorable and similar cost-effectiveness profiles .
CONCLUSIONS	The model results should be interpreted within the specific clinical settings of each trial .
CONCLUSIONS	Selection of MR , RIT , or observation should be based on patient characteristics and expected trade-offs for these alternatives .

###24959732
OBJECTIVE	To evaluate the effectiveness of a topically applied gel containing essential oils ( menthol and thymol ) and polyphenolic antioxidants ( phloretin and ferulic acid ) for reducing halitosis in dogs .
METHODS	20 dogs .
METHODS	A blinded crossover clinical trial was conducted .
METHODS	Dogs received a dental cleaning and examination ( periodontal examination including periodontal probing and assessments of plaque , calculus , and gingivitis ) .
METHODS	Owners then applied a gel ( active or placebo ) to oral soft tissues twice daily for a 4-week period .
METHODS	Teeth of the dogs were cleaned again , and owners applied the other gel for a 4-week period .
METHODS	Clinicians scored halitosis immediately after the initial cleaning and at 4 and 8 weeks , and owners scored halitosis weekly .
RESULTS	Halitosis assessment by clinicians revealed that both groups had improvement in halitosis scores .
RESULTS	Two dogs were removed because of owner noncompliance .
RESULTS	In the active-to-placebo group ( n = 9 ) , halitosis was significantly reduced during application of the active gel but increased during application of the placebo .
RESULTS	Seven of 9 owners reported increased halitosis when treatment was changed from the active gel to the placebo .
RESULTS	In the placebo-to-active group ( n = 9 ) , halitosis decreased during application of the placebo and continued to decrease during application of the active gel .
RESULTS	Seven of 9 owners reported a decrease in halitosis with the active gel .
CONCLUSIONS	An oral topically applied gel with essential oils and polyphenolic antioxidants applied daily after an initial professional dental cleaning decreased oral malodor in dogs .

###25127405
BACKGROUND	The SNAP ( Smoking and Nicotine in Pregnancy ) trial compared nicotine replacement therapy ( NRT ) patches with placebo in pregnant smokers ; although NRT doubled cessation rates in the first 4 weeks , by delivery no differences in maternal smoking or birth outcomes were noted .
BACKGROUND	As a result , NRT used in standard doses during pregnancy is considered ineffective for smoking cessation .
BACKGROUND	Subsequent effects of NRT on the children of treated mothers are unknown because no trials have investigated the effect of gestational NRT use beyond birth .
BACKGROUND	To assess whether NRT use in pregnancy might cause harm to infants , we aimed to compare effects of NRT and placebo on infant development 2 years after delivery .
METHODS	1050 pregnant smokers aged 16-45 years , at 12-24 weeks ' gestation , and smoking at least five cigarettes per day were recruited from seven hospitals in England between May 1 , 2007 , and Feb 26 , 2010 , and followed up until their infants were 2 years old .
METHODS	Participants were randomly assigned ( 1:1 ) to receive up to 8-weeks treatment with NRT ( 15 mg/16 h transdermal patches ) or identically packaged and visually matched placebo patches ( all patches manufactured by and purchased at market rate from United Pharmaceuticals , Amman , Jordan ) , issued as two 4-week supplies ( 521 for NRT group , 529 for placebo group ) [ Corrected ] .
METHODS	Randomisation was stratified by site with participants , health-care professionals , and research staff masked to treatment allocation .
METHODS	The primary results for participants and infants at delivery were published in 2012 ; we present results from the trial cohort 2 years after birth .
METHODS	After delivery , questionnaires were posted to participants and , if there was no response , to family physicians .
METHODS	The primary outcome at 2 years was infants ' survival without developmental impairment ( ie , no disability or problems with behaviour or development ) .
METHODS	Treatment groups were compared on an intention-to-treat basis .
METHODS	The trial is registered with Controlled-Trials .
METHODS	com , number ISRCTN07249128 .
RESULTS	Questionnaires were returned at 2 years for 891 ( 88 % ) of 1010 live singleton births ( 445 of ( 88 % ) 503 given NRT and 446 ( 88 % ) of 507 given placebo ) .
RESULTS	Because of missing data , developmental outcomes , including four infant deaths , were documented for 888 of ( 88 % ) 1010 singleton infants ; 445 ( 88 % ) of 503 infants in NRT group and 443 ( 87 % ) of 507 infants in placebo .
RESULTS	In the NRT group , 323 ( 73 % ) of 445 infants had no impairment compared with 290 ( 65 % ) of 443 infants in the placebo group ( odds ratio [ OR ] 1.40 , 95 % CI 1.05-1 .86 , p = 0.023 ) .
RESULTS	At 2 years , 15 ( 3 % ) of 521 mothers in the NRT group and nine ( 2 % ) of 529 mothers in the placebo groups self-reported prolonged smoking abstinence since a quit date set in pregnancy ( OR 1.71 , 95 % CI 0.74-3 .94 , p = 0.20 ) .
RESULTS	Adverse events were not collected after delivery , but previously reported adverse pregnancy and birth outcomes were similar in the two groups .
CONCLUSIONS	Infants born to women who used NRT for smoking cessation in pregnancy were more likely to have unimpaired development .
CONCLUSIONS	NRT had no effect on prolonged abstinence from smoking but did cause a temporary doubling of smoking cessation shortly after randomisation during pregnancy , which could explain findings .
CONCLUSIONS	If findings are confirmed by subsequent research , this has potential implications for the management of smoking in pregnancy .
BACKGROUND	National Institute for Health Research Health Technology Assessment Programme .

###24828298
BACKGROUND	Isotretinoin has been used in combination with oral psoralen + UVA ( PUVA ) and narrowband UVB ( NBUVB ) for treating psoriasis , especially in women of child-bearing age .
BACKGROUND	The efficacy of oral psoralen + sun exposure ( PUVAsol ) is comparable to that of PUVA .
BACKGROUND	This study was planned to compare the efficacy of oral PUVAsol with that of the combination of oral isotretinoin and PUVAsol in patients with chronic plaque psoriasis .
METHODS	Forty patients with psoriasis vulgaris were randomized to two groups .
METHODS	Group A ( control group ) received PUVAsol only .
METHODS	Group B ( intervention group ) received PUVAsol + isotretinoin ( 0.5 mg/kg/day ) .
METHODS	Psoriasis Area Severity Index ( PASI ) score was recorded at baseline and weeks 4 , 8 and 12 .
METHODS	Dermatology Life Quality Index was assessed at baseline and 12 weeks .
METHODS	The end point of the study was PASI 75 or 12 weeks , whichever came earlier .
RESULTS	Thirty-five patients completed the study .
RESULTS	There were statistically significant differences between the two study groups for the number of patients achieving the endpoint of PASI 75 , PASI scores at the end of 12 weeks , mean duration to achieve PASI 75 , number of PUVAsol sessions needed to achieve PASI75 and mean cumulative dosage of 8-methoxypsoralen needed to achieve PASI 75 .
CONCLUSIONS	The combination of isotretinoin with PUVAsol is more effective compared with PUVAsol alone for treating chronic plaque psoriasis .

###25592198
OBJECTIVE	Leisure-time physical activity ( LTPA ) and exercise training are essential parts of current guidelines for patients with coronary artery disease ( CAD ) .
OBJECTIVE	However , the contributions of LTPA and exercise training to cardiovascular ( CV ) risk in CAD patients with type 2 diabetes ( T2D ) are not well established .
METHODS	We examined the effects of LTPA ( n = 539 and n = 507 ; with and without T2D , respectively ) and 2-year controlled , home-based exercise training ( n = 63 plus 64 control subjects with T2D and n = 72 plus 68 control subjects without T2D ) on the CV risk profile and composite end point among CAD patients .
RESULTS	During the 2-year follow-up , patients with reduced LTPA at baseline had an increased risk of CV events ( adjusted hazard ratio 2.3 [ 95 % CI 1.1-5 .1 ; P = 0.033 ] , 2.1 [ 1.1-4 .2 ; P = 0.027 ] , and 2.0 [ 1.0-3 .9 ; P = 0.044 ] for no LTPA , LTPA irregularly , and LTPA two to three times weekly , respectively ) compared with those with LTPA more than three times weekly .
RESULTS	Among patients who completed the 2-year exercise intervention , exercise training resulted in favorable changes in exercise capacity both in CAD patients with T2D ( +0.2 0.8 vs. -0.1 0.8 MET , P = 0.030 ) and without T2D ( +0.3 0.7 vs. -0.1 0.5 MET , P = 0.002 ) as compared with the control group but did not have any significant effects on major metabolic or autonomic nervous system risk factors in CAD patients with or without T2D .
CONCLUSIONS	There is an inverse association between habitual LTPA and short-term CV outcome , but controlled , home-based exercise training has only minor effects on the CV risk profile in CAD patients with T2D .

###25370890
OBJECTIVE	Eating difficulty is a critical and common problem in head and neck cancer patients undergoing radiotherapy ( RT ) .
OBJECTIVE	It leads to poor quality of life and extensive tube feeding use .
OBJECTIVE	Nutri-jelly , a food gel with semisolid texture , water-releasing ability , and ready-to-eat by spoon , was recently developed to alleviate the trouble .
OBJECTIVE	However , its efficacy was unknown .
OBJECTIVE	This study investigated the potential effect of Nutri-jelly on health-related quality of life ( HRQOL ) and nasogastric tube feeding use .
METHODS	A prospective quasi-randomized patients-preference controlled trial was conducted in 74 head and neck cancer patients .
METHODS	Subjects in study and control groups ( 37 each ) had similar baseline HRQOL and body mass index and undergone definitive radiotherapy ( 25-35 RT fractions , 5,000-7 ,000 cGy ) .
METHODS	Only study group received a 200-ml box of Nutri-jelly as daily supplement throughout radiotherapy .
METHODS	HRQOL was scored by validated questionnaires .
METHODS	The use of tube feeding was collected from medical records .
RESULTS	From 11 to 35 RT fractions , the study group maintained higher overall HRQOL score than that of control group ( p < 0.0001 ) .
RESULTS	Multiple physiologic and psychological aspects of HRQOL especially swallowing difficulty and overall eating problems were significantly improved in study as compared to control group .
RESULTS	Promisingly , the percentage of tube feeding use in study group ( 13.5 % ) was dramatically lower than control group ( 48.6 % ) .
CONCLUSIONS	Continuous supplementation of Nutri-jelly throughout radiotherapy may improve HRQOL and reduce tube feeding demand in head and neck cancer patients who preferred to take them .
CONCLUSIONS	Nutri-jelly could be an alternative for head and neck cancer patients who have eating difficulty during radiotherapy .

###24811959
OBJECTIVE	To perform the first randomized controlled trial comparing soft contact lens ( SCL ) with rigid gas-permeable lens ( RGPL ) wearing in infantile nystagmus ( IN ) , using spectacle wear as a baseline .
METHODS	Randomized , controlled cross-over trial with an intention-to-treat design .
METHODS	A total of 24 participants with IN ( 12 idiopathic , 12 with albinism ) .
METHODS	Participants were randomized into 1 of 2 treatment arms receiving the following sequence of treatments ( 2-3 weeks for each treatment ) : ( A ) spectacles , SCL , RGPL , and spectacle wear ; or ( B ) spectacles , RGPL , SCL , and spectacle wear .
METHODS	The main outcome measure was mean intensity of nystagmus at the null region viewing at 1.2 m. Secondary outcome measures included the same measure at 0.4 m viewing and across the horizontal meridian ( measured over a 30 range at 3 intervals ) for distance and near .
METHODS	The nystagmus foveation characteristics were similarly assessed over 30 and at the null region at 1.2 m and 0.4 m viewing .
METHODS	Visual outcome measures included best-corrected visual acuity ( BCVA ) at 4 m and 0.4 m , gaze-dependent visual acuity ( GDVA ) ( i.e. , visual acuity when maintaining gaze angles over a 30 range at 10 intervals ) at 4 m , and reading performance at 0.4 m derived from the Radner reading chart .
RESULTS	There were no significant differences between SCL and RGPL wearing for any nystagmus characteristics or compared with spectacle wearing .
RESULTS	The BCVA , reading acuity , and critical print size were significantly worse for SCL wearing compared with RGPL and baseline spectacle wear ( P < 0.05 ) , although mean differences were less than 1 logarithm of the minimum angle of resolution ( logMAR ) line .
CONCLUSIONS	Nystagmus was not significantly different during SCL and RGPL wearing in IN , and contact lens wearing does not significantly reduce nystagmus compared with baseline spectacle wearing .
CONCLUSIONS	The wearing of SCL leads to a small but statistically significant deterioration in visual function compared with both RGPL and spectacle wearing at baseline , although mean effect sizes were not clinically relevant .

###24902673
BACKGROUND	The value of qigong in the treatment of chronic low back pain is unclear .
BACKGROUND	In a randomized controlled trial , we evaluated whether qigong is non-inferior to exercise therapy in patients with chronic low back pain .
METHODS	German outpatients ( aged 46.710.4 ) with chronic low back pain [ mean visual analogue scale ( VAS ) , 53.912.5 mm ] were enrolled and randomly allocated in a 1:1 ratio to receive either qigong ( 64 patients , 12 sessions with 190min/week over 3 months ) or exercise therapy ( 63 patients , 12 sessions 160min/week ) .
METHODS	The primary outcome measure was the average pain intensity over the last 7 days on a VAS ( 0-100mm , 0 = no pain , 100 = worst imaginable pain , non-inferiority margin = 5mm ) after 3 months .
METHODS	Follow-up was measured after 6 and 12 months .
RESULTS	The mean adjusted low back pain intensity after 3 months was 34.8 mm [ 95 % confidence interval ( CI ) 29.5 ; 40.2 ] in the qigong group and 33.1 mm ( 95 % CI 27.7 ; 38.4 ) in the exercise group .
RESULTS	Non-inferiority of the qigong group compared with the exercise group failed to show statistical significance ( p = 0.204 ) .
RESULTS	In both groups , 10 patients reported suspected adverse reactions ( e.g. , muscle soreness , dizziness , pain ) the total number was comparable in both groups ( qigong n = 40 , exercise n = 44 ) .
CONCLUSIONS	Qigong was not proven to be non-inferior to exercise therapy in the treatment of chronic low back pain .
CONCLUSIONS	Its role in the prevention of chronic low back pain might be addressed in further studies .

###24448756
OBJECTIVE	Maintaining target hemoglobin ( Hb ) with minimal variability is a challenge in hemodialysis ( HD ) patients .
OBJECTIVE	The aim of this study is to compare the long - and short-acting erythropoietin-stimulating agents such as Aranesp and Eprex in achieving these targets .
METHODS	Randomized , prospective , open-labeled study of 24 weeks includes stable patients on HD > 3 months , age > 18 years , and on Eprex for > 3 months .
METHODS	Patients were randomized into two groups : A - ( Aranesp group ) : HD patients on Eprex Q TIW or BIW were converted to Aranesp Q weekly , by using the conversion factor of 200:1 and those on Eprex Q weekly to Aranesp Q 2 weeks ; B - ( Eprex group ) : patients continued on Eprex treatment .
METHODS	Hemoglobin target was set at ( 105-125 g/l ) .
METHODS	Primary end points were percentage of patients achieving target Hb , hemoglobin variability , and number of dose changes in each group .
RESULTS	This study consisted of 139 HD patients : 72 in the Aranesp and 67 in the Eprex-mean ( SD ) age 54 ( 16.2 ) years , 77 ( 55 % ) males .
RESULTS	About 46 % were diabetic .
RESULTS	Target Hb achieved in 64.8 % of the Aranesp and 59.7 % in the Eprex ( p = 0.006 ) .
RESULTS	Hb variability was less frequent in the Aranesp group ( p = 0.2 ) .
RESULTS	Mean number of dose changes was 1.3 ( 0.87 ) in the Aranesp and 1.9 ( 1.2 ) in the Eprex ( p < 0.001 ) .
RESULTS	There was 1 vascular access thrombosis in the Aranesp and 8 in the Eprex ( p < 0.001 ) .
RESULTS	There was no difference in hospitalization and death number between the 2 groups .
CONCLUSIONS	Aranesp Q weekly or every 2 weeks is more efficient in achieving target Hb , with less dose changes and minor vascular access complications .

###24704801
BACKGROUND	The vertebral column is the most common site of bone metastases irrespective of the primary tumor .
BACKGROUND	Vertebral metastases are a major cause of motor deficit of the lower extremities .
BACKGROUND	The use of radiotherapy is the treatment of choice in these patients .
BACKGROUND	A temporary worsening of pain shortly during the course of palliative radiotherapy is clinically a common problem .
BACKGROUND	Steroid infusion has well-documented neuroprotective effects .
OBJECTIVE	Our study objective is to evaluate the effect of pre-emptive infusion of methylprednisolone on pain flare and motor function in patients with vertebral metastases .
METHODS	One hundred twenty patients with vertebral metastases received short-course external beam radiotherapy as high-voltage irradiation with a 6 MeV , via linear accelerator .
METHODS	In addition to the short-course radiotherapy , 60 patients received pre-emptive methylprednisolone infusion ( 5 mg/kg ) the day just before initiation of radiotherapy ( Group 1 [ G1 ] ) .
METHODS	The other 60 patients received short-course radiotherapy without pretreatment methylprednisolone infusion , and only normal saline was infused ( Group 2 [ G2 ] ) .
METHODS	The Brief Pain Inventory , incidence of pain flare during radiotherapy , and motor functions were evaluated using the Tomita scale at the time of initial assessment , at the end of external beam radiotherapy , and after two weeks .
RESULTS	Four patients ( 6.6 % ) in G1 experienced pain flare compared with 12 patients ( 20 % ) in G2 during the two-week short-course radiotherapy .
RESULTS	The mean values of pain scores were significantly reduced in both groups at the end of radiotherapy ; the mean value of worst , average , and current pain scores in G1 remained statistically significant in comparison to pretreatment and G2 mean values two weeks later .
RESULTS	Significant increase was noticed in patients with normal motor and ambulatory status in G1 at two and four weeks of initial assessment .
CONCLUSIONS	Pre-emptive methylprednisolone infusion is an effective prophylactic agent in the prevention of radiation-induced pain flare and improves functional motor status after short-term radiotherapy in patients with vertebral metastases .

###24392555
OBJECTIVE	To evaluate the effectiveness of subconjunctival bevacizumab and topical bevacizumab in preventing neovascularisation on high-risk corneal grafts .
METHODS	The randomised , controlled , parallel group study was carried out from February 2008 to April 2012 at Isra Postgraduate Institute of Ophthalmology and Yasin Eye Hospital , Karachi .
METHODS	Eyes with high-risk corneal transplantation with corneal neovascularisation were included in the trial .
METHODS	Patients were randomly allocated to 3 groups : A , B and C.
METHODS	After penetrating keratoplasty , Group A patients received subconjunctival bevacizumab ( 2.5 mg / 0.1 ml ) , Group B , patients received sham injection , while Group C patients received topical bevacizumab ( 2.5 % , 25 mg/ml ) .
METHODS	lt was self-administered 4 times a day for 24 weeks .
METHODS	Group B was the control group .
METHODS	Corneal neovascular invasion area was measured using mathematical software programme Mat Lab .
METHODS	Data analyses were done using SPSS version 19 .
RESULTS	Of the total 122 patients , there were 41 ( 33.88 % ) each in Group A and B , while Group C had 40 ( 32.78 % ) patients .
RESULTS	Among the 3 groups , mean corneal neovascular invasion area was minimum in Group A ( n = 3 ; 6.23 % ) , while in Group B it was 12.3 % ( n = 5 ) .
RESULTS	Group C had the maximum corneal neovascular invasion area after 24 weks ( n = 11 ; 26.7 % ) .
RESULTS	Maximum number of patients ( n = 36 ; 87.80 % ) attained visual acuity of 6/36 or better in Group Afollowed by Group C ( n = 26 ; 65 % ) and Group B ( n = 17 ; 41.46 % ) .
CONCLUSIONS	Subconjunctival bevacizumab reduces the recurrence of neovascularisation and , thus , helps increasing the frequency of graft survival in cases of high-risk corneal transplants .
CONCLUSIONS	When used topically , it is less effective .

###25534960
BACKGROUND	The acute consumption of dietary nitrate has been shown to improve exercise capacity in athletes , healthy adults and subjects with peripheral vascular disease .
BACKGROUND	Many COPD patients have reduced exercise capacity .
BACKGROUND	We hypothesized that acute nitrate consumption might increase incremental shuttle walk test ( ISWT ) distance in COPD subjects .
METHODS	Eleven COPD subjects were randomly assigned to consume either a high nitrate or a matched , low nitrate beverage in a double-blind , randomized , placebo-controlled , crossover design .
METHODS	ISWT distance was measured both before and 3 h after the beverage and change was recorded .
METHODS	After a 7-day washout , ISWT distances were re-measured before and 3 h after the alternate beverage and changes were recorded .
RESULTS	We observed an increase in ISWT distance after consuming the high nitrate juice ( 25 m ) compared with a reduction after the low nitrate juice ( 14 m ) ( p < 0.01 ) .
RESULTS	This improvement in exercise capacity was associated with significant increases in serum nitrate ( p < 0.000005 ) and nitrite ( p < 0.01 ) levels and a significant lowering of resting blood pressure ( < 0.05 ) .
CONCLUSIONS	In patients with stable COPD , the acute consumption of dietary nitrate increased serum nitrate/nitrite levels and exercise capacity and was associated with a decrease in resting blood pressure .
CONCLUSIONS	Nitrate consumption might alter exercise capacity in COPD patients .

###25129551
OBJECTIVE	Induction chemotherapy is associated with anemia in non-small cell lung cancer ( NSCLC ) patients undergoing radiotherapy .
OBJECTIVE	This randomized , open-label study compared the effect of sequential radiochemotherapy ( RCHT ) versus RCHT + epoetin alfa ( RCHT + EPO ) , with respect to 2-year overall survival ( OS ) .
METHODS	Patients 18 years received sequential RCHT ; one arm also received EPO ( chemotherapy day 1 , when Hb < 12 g/dL ) .
METHODS	Kaplan-Meier analysis with log-rank test , and Cox-regression methods were performed .
RESULTS	Of the 385 patients randomized ( RCHT + EPO : n = 195 ; RCHT : n = 190 ) , 78 ( RCTH + EPO : 46 [ 23.6 % ] ; RCHT : 32 [ 16.8 % ] ) were anemic at baseline .
RESULTS	Two-year OS was higher in RCHT + EPO-treated versus RCHT-treated ( 28.5 % [ 95 % CI : 22.2-35 .1 % ] versus 20.6 % [ 95 % CI : 15.1-26 .8 % ] [ p = 0.2278 ] ) , and requirement for RBC transfusion was lower ( 24/195 [ 12.3 % ] versus 61/190 [ 32.1 % ] ) .
RESULTS	In anemic ( baseline ) patients ( post hoc analysis ) , median survival was shorter in RCTH-treated ( 212 days ) versus RCHT + EPO-treated ( 343 days ) ( Hazard ratio = 1.62 [ 95 % CI : 0.99-2 .63 ] , p = 0.0525 ) .
RESULTS	Adverse events were documented in 72.7 % ( RCHT + EPO : 75.0 % ; RCHT : 70.5 % ) patients , and thrombovascular events ( TVEs ) in 45 patients ( RCHT + EPO : 16.7 % ; RCHT : 7.9 % ; p = 0.0099 ) .
CONCLUSIONS	A statistically non-significant trend for 2-year OS was observed in a sub-group of EPO-treated NSCLC-patients with baseline anemia , although this trend was not maintained in the overall population with inoperable NSCLC .

###25449557
OBJECTIVE	The aim of the study was to investigate the functional differences between N20m and P30m components of somatosensory-evoked magnetic cortical field ( SEF ) in young and senior subjects .
METHODS	Twenty-nine healthy subjects , 13 younger ( mean age : 21.8 years ) and 16 senior ( 63.8 years ) , participated .
METHODS	Magnetic fields were measured using a 160-channel , whole head MEG .
METHODS	Single - and paired-pulse stimulations of 200 artifact-free MEG signal epochs were averaged separately .
METHODS	We calculated how aging affects recovery function of SEFs .
RESULTS	The senior showed a prolonged N20m peak latency compared to the younger , although the P30m peak latency was not significantly different between groups .
RESULTS	The N20m ratios at 60 and 80 ms in the senior were significantly increased compared to the ratios in the younger ( 60 ms : P < 0.05 , 80 ms : P < 0.001 ) .
RESULTS	The P30m ratios at inter-stimulus interval ( ISI ) of 80 and 100 ms showed even disinhibition in the senior than in the younger ( P < 0.05 ) .
RESULTS	The younger also showed a significantly negative correlation between P30m and N20m components ' recovery curves ( R = 0.72 , P < 0.05 ) .
CONCLUSIONS	Aging-related changes that occurred in recovery functioning were the decrease in N20m component suppression and the increase in P30m component recovery , indicating that the N20m and P30m components have different functions in aging-related recovery changes .
CONCLUSIONS	Our results show that the N20m ratio at an ISI of 80 ms was significantly increased in the senior group , indicating that the second stimulus-evoked SEF was less inhibited by the initial stimulus at this ISI , suggesting less refractory effect or increased disinhibition .

###25440265
BACKGROUND	Cell-saving devices ( CS ) are frequently used in cardiac surgery to reduce transfusion requirements , but convincing evidence from randomized clinical trials is missing .
BACKGROUND	Filtration of salvaged blood in combination with the CS is widely used to improve the quality of retransfused blood , but there are no data to justify this approach .
METHODS	To determine the contribution of CS and filters on transfusion requirements , we performed a multicenter factorial randomized clinical trial in two academic and four nonacademic hospitals .
METHODS	Patients undergoing elective coronary , valve , or combined surgical procedures were included .
METHODS	The primary end point was the number of allogeneic blood products transfused in each group during hospital admission .
RESULTS	From 738 included patients , 716 patients completed the study ( CS + filter , 175 ; CS , 189 ; filter , 175 ; neither CS nor filter , 177 ) .
RESULTS	There was no significant effect of CS or filter on the total number of blood products ( fraction [ 95 % confidence interval ] : CS , 0.96 [ 0.79 , 1.18 ] ; filter , 1.17 [ 0.96 , 1.43 ] ) .
RESULTS	Use of a CS significantly reduced red blood cell transfusions within 24 hours ( 0.75 [ 0.61,0.92 ] ) , but not during hospital stay ( 0.86 [ 0.71 , 1.05 ] ) .
RESULTS	Use of a CS was significantly associated with increased transfusions of fresh frozen plasma ( 1.39 [ 1.04 , 1.86 ] ) , but not with platelets ( 1.25 [ 0.93 , 1.68 ] ) .
RESULTS	Use of a CS significantly reduced the percentage of patients who received any transfusion ( odds ratio [ 95 % confidence interval ] : 0.67 [ 0.49 , 0.91 ] ) , whereas filters did not ( 0.92 [ 0.68 , 1.25 ] ) .
CONCLUSIONS	Use of a CS , with or without a filter , does not reduce the total number of allogeneic blood products , but reduces the percentage of patients who need blood products during cardiac surgery .

###24287674
METHODS	A prospective clinical study assessing new vertebral compression fracture after previous treatment .
OBJECTIVE	The purpose of this study was to investigate the incidence and associated risk factors of new symptomatic osteoporotic vertebral compression fractures ( OVCFs ) in patients treated by percutaneous vertebroplasty ( PVP ) and kyphoplasty ( PKP ) versus conservative treatment , and to elucidate our findings .
OBJECTIVE	There are a lot of reports concerning the feasibility and efficacy of this minimally invasive procedure compared with conservative treatment , especially in pain soothing .
OBJECTIVE	However , it is still unclear whether the risk of subsequent fracture has increased among operative treatment patients in the long term .
METHODS	From November 2005 to July 2009 , 290 consecutive patients with 363 OVCFs were randomly selected for PVP/PKP or conservative treatment and evaluated with a mean follow-up of 49.4 months ( 36-80 months ) .
METHODS	Some parameters were characterized and statistically compared in this study .
METHODS	Telephone questionnaires , clinical reexamine , and plain radiographs were performed in the follow-up .
RESULTS	Thirty-one of 290 ( 10.7 % ) patients had experienced 42 newly developed symptomatic secondary OVCFs .
RESULTS	Among 169 operation ( 53.3 % vertebroplasty , 46.7 % kyphoplasty ) and 121 comparison patients , there is no significant statistical difference of new OVCFs incidence between the two groups calculated by patient proportion .
RESULTS	However , in separate , the rate of secondary adjacent fractures calculated by vertebral refracture number is significantly higher than non-adjacent levels in PVP/PKP group but no significant statistical difference was observed in conservative group .
RESULTS	The time interval of recompression after operative procedure was much shorter than that for comparison group ( 9.7 17.8 versus 22.4 7.99 months , p = 0.017 ) .
RESULTS	In addition , older age , gender , fracture times , location of original fracture segment , the amount of cement , cement leakage , operation modality ( PVP or PKP ) , and initial number of OVCFs were documented , but these were not the influencing factors in this study ( p > 0.05 ) .
CONCLUSIONS	Patients who had experienced PVP/PKP were not associated with an increased risk of recompression in new levels .
CONCLUSIONS	However , recompression in new levels of PVP/PKP group occurred much sooner than that of conservative group in the follow-up period .
CONCLUSIONS	The incidence of new vertebral fractures observed at adjacent levels was substantially higher but no sooner than at distant levels in PVP/PKP group .
CONCLUSIONS	No major risk factors involving new OVCFs have been found in this study and augmentation for sandwich situation is not necessary .

###25124078
OBJECTIVE	Viral load ( VL ) monitoring is recommended , but seldom performed , in resource-constrained countries .
OBJECTIVE	RV288 is a US President 's Emergency Plan for AIDS Relief ( PEPFAR ) basic programme evaluation to determine the proportion of patients on treatment who are virologically suppressed and to identify predictors of virological suppression and recovery of CD4 cell count .
OBJECTIVE	Analyses from Uganda are presented here .
METHODS	In this cross-sectional , observational study , patients on first-line antiretroviral therapy ( ART ) ( efavirenz or nevirapine + zidovudine/lamivudine ) from Kayunga District Hospital and Kagulamira Health Center were randomly selected for a study visit that included determination of viral load ( HIV-1 RNA ) , CD4 cell count and clinical chemistry tests .
METHODS	Subjects were recruited by time on treatment : 6-12 , 13-24 or > 24 months .
METHODS	Logistic regression modelling identified predictors of virological suppression .
METHODS	Linear regression modelling identified predictors of CD4 cell count recovery on ART .
RESULTS	We found that 85.2 % of 325 subjects were virologically suppressed ( viral load < 47 HIV-1 RNA copies/ml ) .
RESULTS	There was no difference in the proportion of virologically suppressed subjects by time on treatment , yet CD4 counts were higher in each successive stratum .
RESULTS	Women had higher median CD4 counts than men overall ( 406 vs. 294 cells/L , respectively ; P < 0.0001 ) and in each time-on-treatment stratum .
RESULTS	In a multivariate logistic regression model , predictors of virological suppression included efavirenz use [ odds ratio ( OR ) 0.47 ; 95 % confidence interval ( CI ) 0.22-1 .02 ; P = 0.057 ] , lower cost of clinic visits ( OR 0.815 ; 95 % CI 0.66-1 .00 ; P = 0.05 ) , improvement in CD4 percentage ( OR 1.06 ; 95 % CI 1.014-1 .107 ; P = 0.009 ) , and care at Kayunga vs.Kangulamira ( OR 0.47 ; 95 % CI 0.23-0 .92 ; P = 0.035 ) .
RESULTS	In a multivariate linear regression model of covariates associated with CD4 count recovery , time on highly active antiretroviral therapy ( ART ) ( P < 0.0001 ) , patient satisfaction with care ( P = 0.038 ) , improvements in total lymphocyte count ( P < 0.0001 ) and haemoglobin concentration ( P = 0.05 ) were positively associated , whereas age at start of ART ( P = 0.0045 ) was negatively associated with this outcome .
CONCLUSIONS	High virological suppression rates are achievable on first-line ART in Uganda .
CONCLUSIONS	The odds of virological suppression were positively associated with efavirenz use and improvements in CD4 cell percentage and total lymphocyte count and negatively associated with the cost of travel to the clinic .
CONCLUSIONS	CD4 cell reconstitution was positively associated with CD4 count at study visit , time on ART , satisfaction with care at clinic , haemoglobin concentration and total lymphocyte count and negatively associated with age .

###25787199
BACKGROUND	The benefits and risks of prolonged dual antiplatelet therapy may be different for patients with acute myocardial infarction ( MI ) compared with more stable presentations .
OBJECTIVE	This study sought to assess the benefits and risks of 30 versus 12 months of dual antiplatelet therapy among patients undergoing coronary stent implantation with and without MI .
METHODS	The Dual Antiplatelet Therapy Study , a randomized double-blind , placebo-controlled trial , compared 30 versus 12 months of dual antiplatelet therapy after coronary stenting .
METHODS	The effect of continued thienopyridine on ischemic and bleeding events among patients initially presenting with versus without MI was assessed .
METHODS	The coprimary endpoints were definite or probable stent thrombosis and major adverse cardiovascular and cerebrovascular events ( MACCE ) .
METHODS	The primary safety endpoint was GUSTO ( Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries ) moderate or severe bleeding .
RESULTS	Of 11,648 randomized patients ( 9,961 treated with drug-eluting stents , 1,687 with bare-metal stents ) , 30.7 % presented with MI .
RESULTS	Between 12 and 30 months , continued thienopyridine reduced stent thrombosis compared with placebo in patients with and without MI at presentation ( MI group , 0.5 % vs. 1.9 % , p < 0.001 ; no MI group , 0.4 % vs. 1.1 % , p < 0.001 ; interaction p = 0.69 ) .
RESULTS	The reduction in MACCE for continued thienopyridine was greater for patients with MI ( 3.9 % vs. 6.8 % ; p < 0.001 ) compared with those with no MI ( 4.4 % vs. 5.3 % ; p = 0.08 ; interaction p = 0.03 ) .
RESULTS	In both groups , continued thienopyridine reduced MI ( 2.2 % vs. 5.2 % , p < 0.001 for MI ; 2.1 % vs. 3.5 % , p < 0.001 for no MI ; interaction p = 0.15 ) but increased bleeding ( 1.9 % vs. 0.8 % , p = 0.005 for MI ; 2.6 % vs. 1.7 % , p = 0.007 for no MI ; interaction p = 0.21 ) .
CONCLUSIONS	Compared with 12 months of therapy , 30 months of dual antiplatelet therapy reduced the risk of stent thrombosis and MI in patients with and without MI , and increased bleeding .
CONCLUSIONS	( The Dual Antiplatelet Therapy Study [ The DAPT Study ] ; NCT00977938 ) .

###24590146
BACKGROUND	Accurate restoration of mechanical alignment is an important factor in reconstructive surgery of the lower extremity .
BACKGROUND	Conventional intraoperative methods , such as using an electrocautery cable , provide only a momentary evaluation of alignment .
BACKGROUND	In this study , we evaluated a novel technique using a laser emitter , which projected the mechanical axis of the lower extremity , providing continuous intraoperative information on alignment .
METHODS	Alignment of 16 cadaver lower extremities was measured using the electrocautery cable method , the laser method , and CT scan as the standard measurement .
METHODS	The mechanical axis was defined by a line from the center of the femoral head to the center of the ankle .
METHODS	For simplifying measurements the intersection with the tibial plateau was divided into percentages from the medial border ( 0 % ) to the lateral border ( 100 % ) .
METHODS	For using the laser method a laser emitting and laser catching device was developed , which is positioned and centered on the femoral head and the ankle using an image intensifier .
METHODS	By catching the laser on the knee region the actual mechanical axis is marked .
RESULTS	The data demonstrated good correlation of the laser method when compared to the cable method ( P = 0.44 ) .
RESULTS	Comparison of the average mechanical axis between cable method and CT ( P = 0.819 ) and laser method and CT ( P = 0.647 ) did not show a statistically significant difference .
RESULTS	Average radiation time in comparison between cable method and laser method showed a statistically significant difference ( P = 0.013 ) , with the laser method requiring more radiation time .
CONCLUSIONS	Determination of the mechanical axis during surgery remains a difficult clinical problem .
CONCLUSIONS	Restoration of alignment is an important prognostic factor for surgical outcome .
CONCLUSIONS	Based on these data , the laser method represents a simple , yet effective tool for continuous intraoperative evaluation of lower extremity alignment .

###25126978
OBJECTIVE	The objective of this study was to evaluate the protective effects of a new device for reducing perineal tears during vaginal childbirth .
METHODS	A multicenter open randomized controlled trial ( RCT ) was performed in Helsingborg , Lund and Malm , Sweden consisting of 1148 women .
METHODS	Women anticipating a vaginal delivery were either randomized to the intervention group ( n = 574 in which the perineal protection device was used , or a control group ( n = 574 ) , in which the perineal protection device was not used .
METHODS	The main outcome measurements were incidence of vaginal and perineal tears ( 1st to 4th degree tears ) and adverse effects on the parturient and newborn .
RESULTS	The incidences of first - and second-degree tears of the vagina ( p = 0.018 ) and perineum ( p = 0.005 ) were significantly reduced in the intervention group compared with the controls .
RESULTS	In the intervention - and control group , 184 women ( 34.9 % ) and 142 ( 26.6 % ) showed no perineal tearing , respectively ( p = 0.034 ) .
RESULTS	Numbers needed to treat to avoid any perianal tearing was 12 .
RESULTS	The incidence of anal sphincter rupture ( ASR ) was the same in both groups ( n = 19 ; 3.4 % ) .
RESULTS	No negative effects on mother or child from using the device were observed .
CONCLUSIONS	The perineal protective device significantly reduced the incidence of first - and second-degree tears in the vagina and perineum during vaginal birth and also significantly increased the number of parturients with a fully intact posterior commissure .
CONCLUSIONS	No significant reduction of ASR and no negative effects of the device were observed .

###24261665
BACKGROUND	DNA methylation has been linked to many important biological phenomena .
BACKGROUND	Researchers have recently begun to sequence bisulfite treated DNA to determine its pattern of methylation .
BACKGROUND	However , sequencing reads from bisulfite-converted DNA can vary significantly from the reference genome because of incomplete bisulfite conversion , genome variation , sequencing errors , and poor quality bases .
BACKGROUND	Therefore , it is often difficult to align reads to the correct locations in the reference genome .
BACKGROUND	Furthermore , bisulfite sequencing experiments have the additional complexity of having to estimate the DNA methylation levels within the sample .
RESULTS	Here , we present a highly accurate probabilistic algorithm , which is an extension of the Genomic Next-generation Universal MAPper to accommodate bisulfite sequencing data ( GNUMAP-bs ) , that addresses the computational problems associated with aligning bisulfite sequencing data to a reference genome .
RESULTS	GNUMAP-bs integrates uncertainty from read and mapping qualities to help resolve the difference between poor quality bases and the ambiguity inherent in bisulfite conversion .
RESULTS	We tested GNUMAP-bs and other commonly-used bisulfite alignment methods using both simulated and real bisulfite reads and found that GNUMAP-bs and other dynamic programming methods were more accurate than the more heuristic methods .
CONCLUSIONS	The GNUMAP-bs aligner is a highly accurate alignment approach for processing the data from bisulfite sequencing experiments .
CONCLUSIONS	The GNUMAP-bs algorithm is freely available for download at : http://dna.cs.byu.edu/gnumap .
CONCLUSIONS	The software runs on multiple threads and multiple processors to increase the alignment speed .

###24620839
OBJECTIVE	This study is an analysis of the pre-trial quality assurance ( QA ) exercises submitted by clinicians from radiotherapy ( RT ) centres across Europe and Canada to qualify for participation in the CONVERT trial .
METHODS	QA exercises submitted by 64 clinicians at 64 RT centres were included in this analysis .
METHODS	The exercises included the completion of a trial-specific questionnaire and submission of a treatment plan , for both trial arms , for a patient fitting the eligibility criteria of the trial .
METHODS	This article describes the QA programme set up for the CONVERT trial and identifies deviations from the trial protocol .
METHODS	Patient eligibility , disease and critical structure outlining and treatment planning technique were assessed .
RESULTS	Results from QA trial-specific questionnaires received between February 2008 and September 2011 , returned as part of the QA exercise , indicated that the majority of centres ( 70.3 % ) were using 6-MV photons and type B treatment planning system algorithms ( 57.8 % ) .
RESULTS	90.6 % of clinicians assessed submitted data for patients who fitted the eligibility criteria for the trial .
RESULTS	There were inconsistencies in outlining of gross tumour volume ( GTV ) and organs at risk , mainly heart and oesophagus , and in the use of margins around the GTV .
CONCLUSIONS	Such a QA programme helps to ensure that centres conform to trial protocol and should reduce inconsistencies in RT planning that may confound the results of the CONVERT trial .
CONCLUSIONS	Few studies reporting pre-trial QA have been published to date .
CONCLUSIONS	This article outlines the importance of such a QA programme in the context of multicentre Phase III studies .

###25518308
BACKGROUND	Pelvic floor muscle exercises ( PFME ) are commonly recommended during pregnancy and after birth for both prevention and treatment of lower urinary tract symptoms ( LUTS ) .
BACKGROUND	Stress urinary incontinence has long been presumed to be associated with urethral hypermobility .
BACKGROUND	Pregnancy and delivery are known cause of increasing bladder neck descent ( BND ) .
OBJECTIVE	The present study aimed to determine the effect of antenatal PFME on bladder neck descent in nulliparous pregnancy .
METHODS	219 nulliparous women pregnant between 8-12 weeks were interviewed and then underwent transperineal ultrasound .
METHODS	Of the total , 108 women were randomly assigned to a PFMT group , while 111 women to a control group .
METHODS	The latter group received routine antenatal care .
METHODS	For the intervention group , patients were taught about PFMT using visual biofeedback by transperineal ultrasound .
METHODS	The PFMT regimen comprised a series of 15 contractions , and each contraction was heldfor 5 seconds , with 5 seconds rest between each contraction .
METHODS	Patients were asked to repeat this regimen for 3 times after each meal .
METHODS	At second trimester , third trimester , 3-month postpartum and 6-month postpartum , the subjects in both groups were interviewed and then underwent another ultrasound assessment .
METHODS	Transperineal ultrasound was performed after bladder emptying , with the patient in the supine position .
METHODS	Bladder neck position was measured at rest and on maximal valsava , and the differences yielded a numerical valueforBND .
METHODS	The sample size was calculated with apower of80 % p < 0.05 was considered significant .
METHODS	SPSS 15 .
METHODS	Ofor windows ( SPSS Inc. , Chicago , Illinois ) was used for statistical analyses .
RESULTS	Demographic characteristics did not differ significantly between PFMT and control groups , showing effective randomization .
RESULTS	Mean age was 26.953.94 and 26.515.41 years for PFMT and control group , respectively ( p = 0.49 ) .
RESULTS	There were no significant differences in bladder symptoms between the two groups at the first visit .
RESULTS	In the first trimester , the average BND of the PFMT group was slightly higher than BND of the control group ( 14.16.9 mm and 12.26.7 mm respectively ( p = 0.04 ) ) .
RESULTS	When comparing delivery mode by using Pearson 's Chi-square test , there was no statistically significant difference between two groups ( p = 0.35 ) .
RESULTS	The mean fetal birth weight of women in the PFMTgroup was 3,084 grams and in the control group was 3,093 grams ( p = 0.88 ) .
RESULTS	At 6 monthspostpartum , 80 women of the PFMT group and 65 women of the control group returned for follow-up .
RESULTS	There were no differences regarding the prevalence ofL UTS between the groups at 6 months after delivery .
RESULTS	Women in the control group had a higher BND ( 16.46.6 mm ) than those in the PFMT group ( 13.97.3 mm , p = 0.03 ) .
RESULTS	This difference was also found in the subgroup of the women who delivered vaginally ( BND = 17.56.7 mm in the control group and 13.27.4 mm in the PFMTgroup , p = 0.006 ) .
CONCLUSIONS	Although postpartum prevalence of LUTS was no different between groups , this study has demonstrated that antenatal pelvic floor muscle exercises may reduce bladder neck mobility at 6 months after childbirth .
CONCLUSIONS	The significance of such an effect remains to be determined .

###25493035
OBJECTIVE	To investigate the clinical response of gastro-esophageal reflux disease ( GERD ) symptoms to exclusion diets based on food intolerance tests .
METHODS	A double blind , randomized , controlled pilot trial was performed in 38 GERD patients partially or completely non-responders to proton pump inhibitors ( PPI ) treatment .
METHODS	Fasting blood samples from each patients were obtained ; leukocytotoxic test was performed by incubating the blood with a panel of 60 food items to be tested .
METHODS	The reaction of leukocytes ( rounding , vacuolization , lack of movement , flattening , fragmentation or disintegration of cell wall ) was then evaluated by optical microscopy and rated as follows : level 0 = negative , level 1 = slightly positive , level 2 = moderately positive , and level 3 = highly positive .
METHODS	A `` true '' diet excluding food items inducing moderate-severe reactions , and a `` control '' diet including them was developed for each patient .
METHODS	Then , twenty patients received the `` true '' diet and 18 the `` control '' diet ; after one month ( T1 ) symptoms severity was scored by the GERD impact scale ( GIS ) .
METHODS	Hence , patients in the `` control '' group were switched to the `` true '' diet , and symptom severity was re-assessed after three months ( T2 ) .
RESULTS	At baseline ( T0 ) the mean GIS global score was 6.68 ( range : 5-12 ) with no difference between `` true '' and control group ( 6.6 1.19 vs 6.7 1.7 ) .
RESULTS	All patients reacted moderately/severely to at least 1 food ( range : 5-19 ) , with a significantly greater number of food substances inducing reaction in controls compared with the `` true '' diet group ( 11.6 vs 7.0 , P < 0.001 ) .
RESULTS	Food items more frequently involved were milk , lettuce , brewer 's yeast , pork , coffee , rice , sole asparagus , and tuna , followed by eggs , tomato , grain , shrimps , and chemical yeast .
RESULTS	At T1 both groups displayed a reduction of GIS score ( `` true '' group 3.3 1.7 , -50 % , P = 0.001 ; control group 4.9 2.8 , -26.9 % , P = 0.02 ) , although the GIS score was significantly lower in `` true '' vs `` control '' group ( P = 0.04 ) .
RESULTS	At T2 , after the diet switch , the `` control '' group showed a further reduction in GIS score ( 2.7 1.9 , -44.9 % , P = 0.01 ) , while the `` true '' group did not ( 2.6 1.8 , -21.3 % , P = 0.19 ) , so that the GIS scores did n't differ between the two groups .
CONCLUSIONS	Our results suggest that food intolerance may play a role in GERD symptoms development , and leucocytotoxic test-based exclusion diets may be a possible therapeutic approach when PPI are not effective or indicated .

###25583911
BACKGROUND	Pediatric traumatic brain injury ( TBI ) contributes to impairments in functioning in everyday settings .
BACKGROUND	Evidence suggests that online family problem-solving therapy ( FPST ) may be effective in reducing adolescent behavioral morbidity .
BACKGROUND	This article examines the efficacy of Counselor-Assisted Problem Solving ( CAPS ) , a form of online FPST in improving long-term functional outcomes of adolescents with TBI relative to Internet resources only .
METHODS	Children , aged 12 to 17 years , who were hospitalized in the previous 7 months for TBI were enrolled in a multisite , assessor-blinded randomized controlled trial .
METHODS	Consented participants were randomly assigned to CAPS or an Internet resource comparison ( IRC ) condition .
METHODS	Outcomes were assessed at baseline and at follow-ups 6 , 12 , and 18 months postbaseline .
METHODS	The Child and Functional Assessment Scale and the Iowa Family Interaction Rating Scale ( IFIRS ) served as primary outcomes of child and family functioning respectively .
RESULTS	For the Child and Functional Assessment Scale total , we found a significant group time interaction , with less impaired functioning for the CAPS group than for the IRC group at the final follow-up .
RESULTS	Parent education moderated the efficacy of CAPS on overall rates of impairment and school/work functioning , with the advantage of CAPS over IRC evident at the final follow-up only for participants with less-educated parents .
RESULTS	Neither group differences nor group time interactions were found for the IFIRS .
CONCLUSIONS	Relatively brief , online treatment shortly after injury may result in long-term improvements in child functioning , particularly among families of lower socioeconomic status .
CONCLUSIONS	Clinical implementation of CAPS during the initial months postinjury should be considered .

###25888838
BACKGROUND	The Troms Intervention Study on Preterms evaluates an early , sensitizing intervention given to parents of prematurely born children ( birth-weight < 2000g ) .
BACKGROUND	The current study investigated the potential influence of the intervention on children 's self-reported and parental proxy-reported quality of life ( QoL ) at children 's age of nine .
METHODS	Participants were randomized to either intervention ( PI , n = 72 ) or preterm control ( PC , n = 74 ) in the neonatal care unit , while healthy term-born infants were recruited to a term reference group ( TR , n = 75 ) .
METHODS	The intervention was a modified version of the Mother-Infant Transaction Program , and comprised eight one-hour sessions during the last week before discharge and four home visits at 1 , 2 , 4 and 12weeks post-discharge .
METHODS	The two control groups received care in accordance with written guidelines drawn up at the hospital .
METHODS	Participants and parents reported QoL independently on the Kinder Lebensqualitt Fragebogen ( KINDL ) questionnaire .
METHODS	Differences between groups were analyzed by SPSS ; Linear Mixed Models and parent-child agreement were analyzed and compared by intra-class correlations within each group .
RESULTS	On average , children in all groups reported high levels of well-being .
RESULTS	The PI children reported better physical well-being than the PC children ( p = 0.002 ) .
RESULTS	In all other aspects of QoL both the PI and the PC children reported at similar levels as the term reference group .
RESULTS	PI parents reported better emotional wellbeing ( p = 0.05 ) and a higher level of contentment in school ( p = 0.003 ) compared with PC parents .
RESULTS	Parent-child agreement was significantly weaker in the PI group than in the PC group on dimensions such as emotional well-being and relationships with friends ( p < 0.05 ) .
RESULTS	PI parents reported QoL similar to parents of terms on all aspects except the subscale self-esteem , while PC parents generally reported moderately lower QoL than TR parents .
CONCLUSIONS	This early intervention appears to have generated long-lasting positive effects , improving perceived physical well-being among prematurely born children and parent 's perception of these children 's QoL in middle childhood .
BACKGROUND	Clinical Trials Gov NCT00222456 .

###24685117
BACKGROUND	Colorectal cancer is an important public health problem in Spain .
BACKGROUND	Over the last decade , several regions have carried out screening programmes , but population participation rates remain below recommended European goals .
BACKGROUND	Reminders on electronic medical records have been identified as a low-cost and high-reach strategy to increase participation .
BACKGROUND	Further knowledge is needed about their effect in a population-based screening programme .
BACKGROUND	The main aim of this study is to evaluate the effectiveness of an electronic reminder to promote the participation in a population-based colorectal cancer screening programme .
BACKGROUND	Secondary aims are to learn population 's reasons for refusing to take part in the screening programme and to find out the health professionals ' opinion about the official programme implementation and on the new computerised tool .
METHODS	This is a parallel randomised trial with a cross-sectional second stage .
METHODS	all the invited subjects to participate in the public colorectal cancer screening programme that includes men and women aged between 50-69 , allocated to the eleven primary care centres of the study and all their health professionals .
METHODS	The randomisation unit will be the primary care physician .
METHODS	The intervention will consist of activating an electronic reminder , in the patient 's electronic medical record , in order to promote colorectal cancer screening , during a synchronous medical appointment , throughout the year that the intervention takes place .
METHODS	A comparison of the screening rates will then take place , using the faecal occult blood test of the patients from the control and the intervention groups .
METHODS	We will also take a questionnaire to know the opinions of the health professionals .
METHODS	The main outcome is the screening status at the end of the study .
METHODS	Data will be analysed with an intention-to-treat approach .
CONCLUSIONS	We expect that the introduction of specific reminders in electronic medical records , as a tool to facilitate and encourage direct referral by physicians and nurse practitioners to perform colorectal cancer screening will mean an increase in participation of the target population .
CONCLUSIONS	The introduction of this new software tool will have good acceptance and increase compliance with recommendations from health professionals .
BACKGROUND	Clinical Trials.gov identifier NCT01877018 .

###24671720
BACKGROUND	In order to assess relationships between thyroid hormone status and findings on brain MRI , a subset of babies was recruited to a multi-centre randomised , placebo-controlled trial of levothyroxine ( LT4 ) supplementation for babies born before 28 weeks ' gestation ( known as the TIPIT study , for Thyroxine supplementation In Preterm InfanTs ) .
BACKGROUND	These infants were imaged at term-equivalence .
METHODS	Forty-five TIPIT participants had brain MRI using diffusion tensor imaging ( DTI ) to estimate white matter development by apparent diffusion coefficient ( ADC ) , fractional anisotropy ( FA ) and tractography metrics of number and length of streamlines .
METHODS	We made comparisons between babies with the lowest and highest plasma FT4 concentrations during the initial 4 weeks after birth .
RESULTS	There were no differences in DTI metrics between babies who had received LT4 supplementation and those who had received a placebo .
RESULTS	Among recipients of a placebo , babies in the lowest quartile of plasma-free thyroxine ( FT4 ) concentrations had significantly higher apparent diffusion coefficient measurements in the posterior corpus callosum and streamlines that were shorter and less numerous in the right internal capsule .
RESULTS	Among LT4-supplemented babies , those who had plasma FT4 concentrations in the highest quartile had significantly lower apparent diffusion coefficient values in the left occipital lobe , higher fractional anisotropy in the anterior corpus callosum and longer and more numerous streamlines in the anterior corpus callosum .
CONCLUSIONS	DTI variables were not associated with allocation of placebo or thyroid supplementation .
CONCLUSIONS	Markers of poorly organised brain microstructure were associated with low plasma FT4 concentrations after birth .
CONCLUSIONS	The findings suggest that plasma FT4 concentrations affect brain development in very immature infants and that the effect of LT4 supplementation for immature babies with low FT4 plasma concentrations warrants further study .

###24689056
BACKGROUND	Periodontitis is an inflammatory process in response to dental biofilm and leads to periodontal tissue destruction .
BACKGROUND	The aim of this study was the comparison of outcomes using either an enamel matrix derivative ( EMD ) or a nanocrystalline hydroxyapatite ( NHA ) in regenerative periodontal therapy after 6 and 12 months .
METHODS	Using a parallel group , prospective randomized study design , we enrolled 19 patients in each group .
METHODS	The primary outcome was bone fill after 12 months .
METHODS	Attachment gain , probing pocket depth ( PPD ) reduction , and recession were secondary variables .
METHODS	Additionally , early wound healing and adverse events were assessed .
METHODS	Data analysis included test of noninferiority of NHA group ( test ) compared to EMD group ( reference ) in bone fill .
METHODS	Differences in means of secondary variables were compared by paired t-test , frequency data by exact ( 2 ) test .
RESULTS	Both groups showed significant bone fill , reduction of PPD , increase in recession , and gain of attachment after 6 and 12 months .
RESULTS	No significant differences between groups were found at any time point .
RESULTS	Adverse events were comparable between both groups with a tendency of more complaints in the NHA group .
CONCLUSIONS	The clinical outcomes were similar in both groups .
CONCLUSIONS	EMD could have some advantage compared to NHA regarding patients comfort and adverse events .
CONCLUSIONS	The trial is registered with ClinicalTrials.gov NCT00757159 .

###24503205
BACKGROUND	Recent neuroimaging studies on poststroke aphasia revealed maladaptive cortical changes in both hemispheres , yet their functional contribution in language recovery remains elusive .
BACKGROUND	The aim of this study was to evaluate the long-term efficacy of dual-hemisphere repetitive transcranial magnetic stimulation ( rTMS ) on poststroke aphasia .
METHODS	Thirty patients with subacute poststroke nonfluent aphasia were randomly allocated to receive real or sham rTMS .
METHODS	Each patient received 1000 rTMS pulses ( 1 Hz at 110 % of resting motor threshold [ rMT ] over the right unaffected Broca 's area and 1000 pulses ( 20 Hz at 80 % rMT ) over the left affected Broca 's area for 10 consecutive days followed by speech/language training .
METHODS	The language section of the Hemispheric Stroke Scale ( HSS ) , the Stroke Aphasic Depression Questionnaire-Hospital Version ( SADQ-H ) , and the National Institutes of Health Stroke Scale ( NIHSS ) were measured before , immediately after the 10 sessions , and 1 and 2 months after the last session .
RESULTS	At baseline , there were no significant differences between groups in demographic and clinical rating scales .
RESULTS	However , there was a significantly greater improvement in the HSS language score as well as in the SADQ-H after real rTMS compared with sham rTMS , which remained significant 2 months after the end of the treatment sessions .
CONCLUSIONS	This is the first clinical study of dual-hemisphere rTMS in poststroke aphasia .
CONCLUSIONS	Combining dual-hemisphere rTMS with language training might be a feasible treatment for nonfluent aphasia ; further multicenter studies are needed to confirm this result .

###24585722
BACKGROUND	The randomized , phase III AVAPERL trial evaluated the safety and efficacy of bevacizumab maintenance with or without pemetrexed in nonsquamous nonsmall-cell lung cancer ( nsNSCLC ) .
BACKGROUND	Progression-free survival ( PFS ) was significantly prolonged with bevacizumab-pemetrexed , but overall survival ( OS ) data were immature .
BACKGROUND	In this article , we report an independent , updated analysis of survival outcomes in AVAPERL .
METHODS	Patients with advanced nsNSCLC received first-line bevacizumab ( 7.5 mg/kg ) , cisplatin ( 75 mg/m ( 2 ) ) , and pemetrexed ( 500 mg/m ( 2 ) ) every 3 weeks ( q3w ) for four cycles .
METHODS	Nonprogressing patients were randomized to maintenance bevacizumab ( 7.5 mg/kg ) or bevacizumab-pemetrexed ( 500 mg/m ( 2 ) ) q3w until progression or consent withdrawal .
METHODS	The primary end point of the trial was PFS ; in this independent OS analysis , participating study centers were contacted to collect survival data on patients still alive at the time of the first analysis .
RESULTS	A total of 376 patients received induction treatment .
RESULTS	Disease control was confirmed in 71.9 % of patients ; 253 patients were randomized to maintenance treatment with bevacizumab ( n = 125 ) or bevacizumab-pemetrexed ( n = 128 ) .
RESULTS	At a median follow-up of 14.8 months , patients allocated to bevacizumab-pemetrexed had significantly improved PFS versus those on bevacizumab when measured from randomization [ 7.4 versus 3.7 months , hazard ratio ( HR ) , 0.57 , 95 % confidence interval ( CI ) 0.44-0 .75 ) ; P < 0.0001 ] .
RESULTS	OS events occurred in 58 % of all patients .
RESULTS	OS was numerically longer with bevacizumab-pemetrexed versus bevacizumab when measured from randomization [ 17.1 versus 13.2 months , HR 0.87 ( 0.63-1 .21 ) ; P = 0.29 ] .
RESULTS	Second-line therapy was administered in 77 % and 70 % of patients in the bevacizumab and bevacizumab-pemetrexed arms , respectively .
RESULTS	No new adverse events were reported during this updated analysis .
CONCLUSIONS	In an unselected population of nsNSCLC patients achieving disease control on platinum-based induction therapy , maintenance with bevacizumab-pemetrexed was associated with a nonsignificant increase in OS over bevacizumab alone .

###24885548
BACKGROUND	Preoperative airway assessment in Denmark is based on a non-specific clinical assessment left to the discretion of the responsible anesthesiologist .
BACKGROUND	The DIFFICAIR trial compares the effect of using a systematic and consistent airway assessment versus a non-specific clinical assessment on the frequency of unanticipated difficult airway management.To prevent outcome bias and selective reporting , we hereby present a detailed statistical analysis plan as an amendment ( update ) to the previously published protocol for the DIFFICAIR trial .
METHODS	The DIFFICAIR trial is a stratified , parallel group , cluster ( cluster = department ) randomized multicenter trial involving 28 departments of anesthesia in Denmark randomized to airway assessment either by the Simplified Airway Risk Index ( SARI ) or by a usual non-specific assessment .
METHODS	Data from patients ' preoperative airway assessment are registered in the Danish Anesthesia Database .
METHODS	An objective score for intubation grading the severity , that is the severity of the intubations , as well as the frequency of unanticipated difficult intubation , is measured for each group.Primary outcome measures are the fraction of unanticipated difficult and easy intubations.The database is programmed so that the registration of the SARI is mandatory for the intervention group but invisible to controls.Data recruitment was commenced in October 2012 and ended in ultimo December 2013 .
CONCLUSIONS	We intend to increase the transparency of the data analyses regarding the DIFFICAIR trial by an a priori publication of a statistical analysis plan .
BACKGROUND	ClinicalTrials.gov : NCT01718561 .

###24779524
OBJECTIVE	To assess the effect of an electronic health record-based transitional care intervention involving automated alerts to primary care providers and staff when older adults were discharged from the hospital .
METHODS	Randomized controlled trial .
METHODS	Large multispecialty group practice .
METHODS	Individuals aged 65 and older discharged from hospital to home .
METHODS	In addition to notifying primary care providers about the individual 's recent discharge , the system provided information about new drugs added during the inpatient stay , warnings about drug-drug interactions , recommendations for dose changes and laboratory monitoring of high-risk medications , and alerts to the primary care provider 's support staff to schedule a posthospitalization office visit .
METHODS	An outpatient office visit with a primary care provider after discharge and rehospitalization within 30 days after discharge .
RESULTS	Of the 1,870 discharges in the intervention group , 27.7 % had an office visit with a primary care provider within 7 days of discharge .
RESULTS	Of the 1,791 discharges in the control group , 28.3 % had an office visit with a primary care provider within 7 days of discharge .
RESULTS	In the intervention group , 18.8 % experienced a rehospitalization within the 30-day period after discharge , compared with 19.9 % in the control group .
RESULTS	The hazard ratio for an office visit with a primary care physician did not significantly differ between the intervention and control groups .
RESULTS	The hazard ratio for rehospitalization in the 30-day period after hospital discharge in the intervention versus the control group was 0.94 ( 95 % confidence interval = 0.81-1 .1 ) .
CONCLUSIONS	This electronic health record-based intervention did not have a significant effect on the timeliness of office visits to primary care providers after hospitalization or risk of rehospitalization .

###24274618
BACKGROUND	Psychological stress may alter immune function by activating physiological stress pathways .
BACKGROUND	Building on our previous study , in which we report that stress management training led to an altered self-reported and cortisol response to psychological stress in patients with rheumatoid arthritis ( RA ) , we explored the effects of this stress management intervention on the immune response to a psychological stress task in patients with RA .
METHODS	In this study , 74 patients with RA , who were randomly assigned to either a control group or a group that received short stress management training , performed the Trier Social Stress Test ( TSST ) 1 week after the intervention and at a 9-week follow-up .
METHODS	Stress-induced changes in levels of key cytokines involved in stress and inflammatory processes ( for example , interleukin ( IL ) -6 and IL-8 ) were assessed .
RESULTS	Basal and stress-induced cytokine levels were not significantly different in patients in the intervention and control groups one week after treatment , but stress-induced IL-8 levels were lower in patients in the intervention group than in the control group at the follow-up assessment .
CONCLUSIONS	In line with our previous findings of lower stress-induced cortisol levels at the follow-up of stress management intervention , this is the first study to show that relatively short stress management training might also alter stress-induced IL-8 levels in patients with RA .
CONCLUSIONS	These results might help to determine the role of immunological mediators in stress and disease .
BACKGROUND	The Netherlands National Trial Register ( NTR1193 )

###24945286
BACKGROUND	The use of intravenous regional anesthesia ( IVRA ) is limited by pain resulting from the application of tourniquets and postoperative pain .
OBJECTIVE	To assess the efficacy of low-level laser therapy added to IVRA for improving pain related to surgical fixation of distal radius fractures .
METHODS	The present double-blinded , placebo-controlled , randomized clinical trial involved 48 patients who were undergoing surgical fixation of distal radius fractures .
METHODS	Participants were randomly assigned to either an intervention group ( n = 24 ) , who received 808 nm laser irradiation as 4 Jpoint for 20 s over ipsilateral three nerve roots in the cervical region corresponding to C5-C8 vertebrae , and 808 nm laser irradiation as 0.1 Jcm2 for 5 min in a tangential scanning mode over the affected extremity ; or a control group ( n = 24 ) , who underwent the same protocol and timing of laser probe application with the laser switched off .
METHODS	Both groups received the same IVRA protocol using 2 % lidocaine .
RESULTS	The mean visual analogue scale scores were significantly lower in the laser-assisted group than in the lidocaine-only group on all measurements during and after operation ( P < 0.05 ) .
RESULTS	The mean time to the first need for fentanyl administration during the operation was longer in the laser group ( P = 0.04 ) .
RESULTS	The total amount of fentanyl administered to patients was significantly lower in the laser-assisted group ( P = 0.003 ) .
RESULTS	The laser group needed significantly less pethidine for pain relief ( P = 0.001 ) and at a later time ( P = 0.002 ) compared with the lidocaine-only group .
RESULTS	There was no difference between the groups in terms of mean arterial pressure and heart rate .
CONCLUSIONS	The addition of gallium-aluminum-arsenide laser irradiation to intravenous regional anesthesia is safe , and reduces pain during and after the operation .

###25407431
BACKGROUND	Physical activity ( PA ) is not only an important marker of physical impairment , but also a pathway to improve quality of life and enhance cognitive and social functioning of old individuals .
BACKGROUND	Yet , making interventional use of PA training as a means for prevention and enhancement of quality of life of nursing home residents has found very limited attention worldwide so far .
BACKGROUND	That said , the project ` Long-term Care in Motion ' ( LTCMo ) as a part of the INNOVAGE consortium ( funded by the European Commission ) has the following aims : Overall : Install and assess a socially innovative intervention in the nursing home ecology .
BACKGROUND	Concrete : ( a ) Conceptualization of a multidimensional intervention program ( resident and staff oriented ) with the potential to promote PA in nursing home residents ; ( b ) Mixed-methods assessment of the program based on automated recording as well as questionnaire data .
METHODS	LTCMo 's PA-related intervention has several components which are applied in parallel manner : ( 1 ) Residents are engaged in a physical exercise program that is based on multiple approaches : supervised group sessions , a serious games approach , and specific training in severely impaired persons ; ( 2 ) Staff members will receive a competence training with a focus on PA motivation and facilitation of residents ' PA engagement .
METHODS	Primary outcome assessment ( movement-related behavior of residents ) is completely conducted by means of automated data collection strategies ( accelerometer-based activity recording , sensor-based life space recording ) .
METHODS	This is enriched by a broad range of secondary outcomes ( e.g. , cognitive performance , depression of residents ; behavioral and attitudinal components of staff ) .
METHODS	Pre - , post - and 3-month follow-up assessment will take place in the target intervention setting as well as in a waiting control condition in which we will also replicate the training and its assessment in a later step .
CONCLUSIONS	Although we are faced with methodological challenges ( e.g. , rather small sample size ; no randomized control trial ) , we believe that our approach has something to offer and indeed has some unique characteristics that may have the potential to contribute to the enhancement of nursing home residents ' quality of life and at the same time further PA-related research with vulnerable populations at large .
BACKGROUND	Current Controlled Trials ISRCTN96090441 .
BACKGROUND	Registered 31 July 2014 .

###25831694
METHODS	A prospective , randomized study wias performed to compare two anesthetic methods .
OBJECTIVE	To evaluate the effect of epidural analgesia on postoperative pain , endocrine - metabolic and inflammatory stress response and cellular inmmune responses during major corrective spine surgetry .
METHODS	The study included 350 patients aged 15 to 65 who were randomly allocated to two equal groups .
METHODS	Group I ( n = 205 ) had continuous epidural analgesia ( E4 ) and sevoflurane anesthesia during surgety and continuous epidural analgesia with ropivacaine and fentanil after surgery ; Group 2 ( n = 145 ) had general anesthesia with sevoflurane and fentanil and systemic administration of opioids after surgery .
METHODS	Patient pain , PONV syndrome , mobility , and satisfaction were measured after surgery along with plasma levels ofcortisol , ghmcose , interleukins IL-1 , IL-6 , and IL-10 during and after surgemy C-reactive protein ( CRP ) , and cell-surface receptor expression of immune cells ( cluster of differentiation ) HLA-DR + / CD3 - , HLA-DR + / CD3 + , HILA-DR , CD3 , CD4 , CD8 , CD16 , CD19 CD16/56 + , and CD16/56 + / CD3 + ) were measured perioperatively .
RESULTS	In group 1 , there were significantly less pain , less nausea , earlier mobility , and higher satisfaction than those in group 2 .
RESULTS	Group I has also demonstrated significantly less plasma levels of glucose , cortisol , CRP , IL-l , IL-6 , IL-10 at various stages .
RESULTS	The ratio of CD4/CD8 ( p = 0.001 ) and B cells ( p = 0.01 ) have increased by postoperative day 3 in group 1 .
RESULTS	NK-cells ( CD16/56 + ) have decreased significantly by day 3 after surgery ( p = 0.001 ) compared to the group 2 .
RESULTS	T-lymphocytes , ( CD3 ) have decreased in all patients , but they were significantly lower in patients receiving opioids , compared wiith EA .
CONCLUSIONS	Polerfulr afferent stimulation in major corrective spine surgery accompanied by immunosuppression for at least a wieek after surgery .
CONCLUSIONS	EA reduces the surgical stress response , prevents postoperative lymphocyte apoptosis and thus , increases stress and infectious resistance .

###24906976
BACKGROUND	Central obesity in polycystic ovary syndrome ( PCOS ) is associated with increased inflammatory markers and increased risk for type 2 diabetes .
OBJECTIVE	To evaluate if improved body composition during treatment with metformin ( M ) vs. oral contraceptive pills ( OCP ) was associated with changes in circulating adiponectin , interleukin ( IL ) -6 , and monocyte chemoattractant protein ( MCP ) -1 .
METHODS	Ninety patients with PCOS were randomized to 12-month treatment with M ( 2 g/day ) , M + OCP ( 150 mg desogestrel + 30 microgram ethinylestradiol ) or OCP .
METHODS	Adiponectin , IL-6 , MCP-1 , whole body DXA scans , and clinical evaluations were performed before and after the intervention period in the 65 study completers .
METHODS	Changes in inflammatory markers and changes in total and regional fat mass estimates .
RESULTS	Adiponectin , IL-6 , and MCP-1 levels were unchanged during the three types of medical intervention .
RESULTS	Treatment with M and M + OCP was superior to OCP regarding decreased regional fat mass .
RESULTS	Baseline adiponectin and IL-6 were associated with BMI , waist , and trunk fat mass .
RESULTS	Changes in trunk fat were significantly associated with changes in IL-6 and MCP-1 during M + OCP .
CONCLUSIONS	Long-term treatment with M alone or in combination with OCP was associated with improved body composition compared to OCP , whereas inflammatory markers were unchanged .
CONCLUSIONS	OCP was not associated with increased inflammatory markers despite a small but significant weight gain .

###24826447
OBJECTIVE	To compare the effects of bupivacaine , lidocaine and saline injections in alleviating post tonsillectomy pain .
METHODS	We recruited 60 patients into the study .
METHODS	All subjects were randomly allocated into 3 groups .
METHODS	Group 1 received 0.9 % sodium chloride ( saline group ) , group 2 received 0.25 % bupivacaine ( bupivacaine group ) and group 3 received 2 % lidocaine ( lidocaine group ) , infiltrated around each tonsil .
METHODS	Pain was evaluated with McGrath 's face scale .
RESULTS	The postoperative pain scores at 2 and 6 hours were similar among the groups ( P > 0.05 ) .
RESULTS	The pain scores in the bupivacaine group were lower than those in the saline group at 12 h ( P < 0.05 ) .
RESULTS	The pain scores in the bupivacaine and lidocaine groups were significantly lower than those in the saline group from 18 to 24 hours until day 7 ( P < 0.05 ) .
RESULTS	There was no difference between the bupivacaine and lidocaine groups ( P > 0.05 ) .
CONCLUSIONS	Local infiltration of bupivacaine is a relatively and safe effective method and is equivalent to use of lidocaine for post tonsillectomy pain .

###25059460
BACKGROUND	The traditional Chinese theory of acupuncture emphasizes that the intensity of acupuncture must reach a threshold to generate de qi ( a specific and compound sensation during the acupuncture ) , which is necessary to achieve the best therapeutic effect .
BACKGROUND	However , the notion that de qi must be achieved for maximum benefit has not been confirmed by modern scientific evidence .
BACKGROUND	This study aims to compare the efficacy of acupuncture with either strong ( intended to elicit de qi ) or weak stimulation among patients with allergic rhinitis .
METHODS	This study compares real versus sham acupuncture in 140 patients with a history of persistent allergic rhinitis ( PER ) or intermittent allergic rhinitis ( IAR ) and with a positive skin prick test ( SPT ) .
METHODS	The trial will be conducted in the Teaching Hospital of Chengdu University of Traditional Chinese Medicine ( China ) .
METHODS	In the study , patients will be randomly assigned into two groups by computer-generated randomization and assessed prior to treatment .
METHODS	They will then receive 12 sessions of treatments for 4 consecutive weeks and have a follow-up phase lasting 12 weeks .
METHODS	The main outcome measures include the primary and secondary indicators .
METHODS	Primary indicators are subjective symptoms scores as evaluated by visual analogue scales ( VAS ) , rhinoconjunctivitis quality of life questionnaires ( RQLQ ) , and the Modified Massachusetts General Hospital acupuncture sensation scale , Chinese version ( C-MMASS ) .
METHODS	The secondary indicators are the results of laboratory examinations , such as serum allergen-specific immunoglobulin E ( sIgE ) nasal inflammatory cells counts ( mast cells , eosinophils , and T cells ) , and nitric oxide concentration in nasal excretion .
METHODS	The use of anti-allergic medication will also be recorded as one of the secondary indicators .
METHODS	Furthermore , adverse events will be recorded and analyzed .
METHODS	Intention-to-treat analysis ( ITT ) and per-protocol ( PP ) analysis will be performed to test and verify the results in this trial .
CONCLUSIONS	The results of this trial will demonstrate the efficacy of using acupuncture to treat allergic rhinitis and verify whether the effectiveness of acupuncture is related to the needle sensation de qi .
BACKGROUND	Chinese Clinical Trial Registry : ChiCTR-TRC-13003594 ( registered on 16 August 2013 , and the first patient was randomized on 27 September 2013 ) .

###24721107
BACKGROUND	The two-operator technique for colonoscopy , with the endoscopy assistant actively advancing and withdrawing the scope , is still commonly practiced in Europe .
BACKGROUND	As uncontrolled data has suggested that the one-operator technique is associated with a higher adenoma detection rate , we tested the hypothesis that the two-operator-technique can achieve comparable performances in terms of adenoma detection .
METHODS	Non-inferiority trial in which consecutive adult outpatients were randomised to undergo colonoscopy by one ( one-operator ) or by four endoscopists .
METHODS	Each performed half the procedures by one-operator and half by two-operator technique independently of routine clinical practice .
METHODS	Main outcome measure was adenoma detection rate .
RESULTS	352 subjects ( 49 % males , mean age 60 12.1 years ) were randomised to one ( n = 176 ) or to two-operator technique ( n = 176 ) colonoscopy .
RESULTS	No significant differences were found in adenoma detection ( 33 % vs. 30.7 % , p = 0.65 ) , or cecal intubation rate , procedure times , and patient tolerability .
RESULTS	No differences were found in the subgroup analysis according to routinely adopted colonoscopy technique .
CONCLUSIONS	This study does not confirm a higher adenoma detection rate for one-operator technique colonoscopy .
CONCLUSIONS	Changing current practice to improve adenoma detection rate for endoscopists routinely using two-operator technique is not warranted .

###24245554
OBJECTIVE	The aim of this case-control study was to compare the efficacy of ethinyl estradiol/drospirenone and Fructus agni casti in women with severe primary dysmenorrhea measuring uterine artery blood flow via Doppler ultrasonography .
METHODS	A total of 60 women with severe primary dysmenorrhea and 30 healthy women ( control ) were included in this study .
METHODS	Thirty patients were treated with ethinyl estradiol 0.03 mg/drospirenone ( group 1 ) and another 30 were treated with Fructus agni casti ( group 2 ) during three menstrual cycles .
METHODS	Before and at the end of third month of therapy visual analog scale ( VAS ) scores , pulsatility index ( PI ) , resistance index ( RI ) of uterine artery were recorded before and after receiving therapy on the first day of the menstrual cycle .
RESULTS	Mean PI and RI values in patients with severe primary dysmenorrhea were significantly higher than in the control groups on the first day of the menstrual cycle ( P < 0.0001 ) .
RESULTS	Mean PI and RI values were significantly lower after the treatment in both groups compared to before values ( P < 0.001 for both ) .
RESULTS	After using the drugs for three menstrual cycles , VAS scores were significantly dropped in both groups compared to before treatment values ( P < 0.0001 for both ) ; however , there were no significant differences in terms of Doppler findings between group 1 and 2 .
CONCLUSIONS	The effectiveness of Fructus agni casti was similar to that of ethinyl estradiol/drospirenone in patients with primary dysmenorrhea .

###25195137
BACKGROUND	Dyspnea and exercise intolerance are the symptoms that most affect the quality of life of children and adolescents with respiratory disorders resulting from cystic fibrosis ( CF ) .
OBJECTIVE	To evaluate the effect of noninvasive ventilation ( NIV ) on treadmill 6-min walk distance and regional chest wall volumes in cystic fibrosis patients .
METHODS	Crossover clinical trial , randomized , controlled and open with 13 children and adolescents with CF , aged 7-16 years , with pulmonary impairment ( NTC01987271 ) .
METHODS	The patients performed a treadmill walking test ( TWT ) during 6min , with and without NIV on a BiLEVEL mode , an interval of 24-48hbetween tests .
METHODS	Before and after each test , patients were assessed by spirometry and optoelectronic plethysmography .
RESULTS	Walking distance in TWT with NIV was significantly higher that without ventilatory support ( meansd : 0.410.08 vs. 0.390.85 km , p = 0.039 ) .
RESULTS	TWT with NIV increase forced expiratory volume on 1s ( FEV1 ; p = 0.036 ) , tidal volume ( Vt ; p = 0.005 ) , minute ventilation ( MV ; p = 0.013 ) , pulmonary rib cage volume ( Vrcp ; p = 0.011 ) , and decrease the abdominal volume ( Vab ; p = 0.013 ) after test .
RESULTS	There was a significant reduction in oxygen saturation ( p = 0.018 ) and permanent increase in respiratory rate after 5min ( p = 0.021 ) after the end test without NIV .
CONCLUSIONS	During the walking test on the treadmill , the NIV change thoracoabdominal kinematics and lung function in order to optimized ventilation and tissue oxygenation , with improvement of walk distance .
CONCLUSIONS	Consequently , NIV is an effective tool to increase functional capacity in children and adolescents with cystic fibrosis .

###26189253
OBJECTIVE	This study aimed to compare three-dimensional conformal radiotherapy ( 3D CRT ) and intensity-modulated radiotherapy ( IMRT ) combined with concurrent chemotherapy for cervical cancer .
METHODS	A total of 72 patients with Grades IIa-IIIb cervical cancer were randomly divided into two groups , namely , the IMRT group for IMRT plan ( primary lesion , 45 Gy/22 ; the pelvic wall lymphatic drainage area , 50 Gy/22 ) , and the 3D CRT group ( conformal pelvic radiotherapy , 45 Gy/22 ; subsequent supplement of pelvic wall , 6.0 Gy/3 ) .
METHODS	Both groups received concurrent chemotherapy of nedaplatin 30 mg/m2 weekly for six cycles , with an after-loading therapy of 6 Gy/6 each time .
RESULTS	In the IMRT group , the grade III diarrhea rate was 5.6 % and the rate in the 3D CRT group was 30.6 % ; both groups significantly differed .
RESULTS	No significant difference was observed between the overall survival and disease-free survival in first , second , and third years in both groups .
CONCLUSIONS	Cervical cancer IMRT can significantly reduce the incidence of acute enteritis .
CONCLUSIONS	For standard 3D CRT , no significant difference was observed in overall survival and disease-free survival .

###24595654
BACKGROUND	The Helicobacter pylori eradication rate with standard triple therapy is very low .
BACKGROUND	H. pylori is known to require the nickel-containing metalloenzymes urease and NiFe-hydrogenase to survive at the low pH environment in the stomach .
OBJECTIVE	To compare the H. pylori eradication rate of a nickel free-diet associated with standard triple therapy and standard triple therapy alone as the first-line regimen .
METHODS	Fifty-two sex - and age-matched patients at the first diagnosis of H. pylori infection were randomized 1:1 into two different therapeutic schemes : ( 1 ) standard LCA ( 26 patients ) : lansoprazole 15 mg bid , clarithromycin 500 mg bid and amoxicillin 1,000 mg bid for 7 days with a common diet ; ( 2 ) standard LCA plus a nickel free-diet ( NFD-LCA ) ( 26 patients ) .
METHODS	Patients followed 30 days of a nickel-free diet plus a week of lansoprazole 15 mg bid , clarithromycin 500 mg bid and amoxicillin 1,000 mg bid starting from day 15 of the diet .
RESULTS	All patients completed the study .
RESULTS	A significantly higher eradication rate was observed in the NFD-LCA group ( 22/26 ) versus LCA group ( 12/26 ) ( p < 0.01 ) .
RESULTS	Only a few patients ( 9 of 52 ) reported the occurrence of mild therapy-related side effects , without any significant differences between the two groups .
CONCLUSIONS	The addition of a nickel-free diet to standard triple therapy significantly increases the H. pylori eradication rate .
CONCLUSIONS	The reduction of H. pylori urease activity due to the nickel-free diet could expose the bacterium to gastric acid and increase H. pylori 's susceptibility to amoxicillin .
CONCLUSIONS	Further studies are necessary to confirm this preliminary result .

###25198068
BACKGROUND	The majority of adults are not meeting the guidelines for physical activity despite activity being linked with numerous improvements to long-term health .
BACKGROUND	In light of this , researchers have called for more community-level interventions .
BACKGROUND	The main objective of the present study was to evaluate whether a community-level physical activity intervention increased the activity levels of rural communities .
METHODS	128 rural villages ( clusters ) were randomised to receive the intervention in one of four time periods between April 2011 and December 2012 .
METHODS	The Devon Active Villages intervention provided villages with 12 weeks of physical activity opportunities for all age groups , including at least three different types of activities per village .
METHODS	Each village received an individually tailored intervention , incorporating a local needs-led approach .
METHODS	Support was provided for a further 12 months following the intervention .
METHODS	The evaluation study used a stepped wedge cluster randomised controlled trial design .
METHODS	All 128 villages were measured at each of five data collection periods using a postal survey .
METHODS	The primary outcome of interest was the proportion of adults reporting sufficient physical activity to meet internationally recognised guidelines .
METHODS	Minutes spent in moderate-and-vigorous activity per week was analysed as a secondary outcome .
METHODS	To compare between intervention and control modes , random effects linear regression and marginal logistic regression models were implemented for continuous and binary outcomes respectively .
RESULTS	10,412 adults ( 4693 intervention , 5719 control ) completed the postal survey ( response rate 32.2 % ) .
RESULTS	The intervention did not increase the odds of adults meeting the physical activity guideline ( adjusted OR 1.02 , 95 % CI : 0.88 to 1.17 ; P = 0.80 ) , although there was weak evidence of an increase in minutes of moderate-and-vigorous-intensity activity per week ( adjusted mean difference = 171 , 95 % CI : -16 to 358 ; P = 0.07 ) .
RESULTS	The ineffectiveness of the intervention may have been due to its low penetration-only 16 % of intervention mode participants reported awareness of the intervention and just 4 % reported participating in intervention events .
CONCLUSIONS	A community-level physical activity intervention providing tailored physical activity opportunities to rural villages did not improve physical activity levels in adults .
CONCLUSIONS	Greater penetration of such interventions must be achieved if they are to increase physical activity prevalence at the community level .
BACKGROUND	Current Controlled Trials ISRCTN37321160 .

###26027624
BACKGROUND	Patients with a recent myocardial infarction ( MI ) present a reduction in functional capacity expressed as a decrease in peak oxygen consumption ( Vo2 peak ) .
BACKGROUND	The impact of a Tai Chi Chuan ( TCC ) cardiac rehabilitation program for patients recovering from recent MI has yet to be assessed .
BACKGROUND	Our goal is to evaluate functional capacity after a TCC-based cardiac rehabilitation program in patients with recent MI .
METHODS	A single-blind randomized clinical trial was conducted .
METHODS	The researchers who performed the tests were blinded to group allocation .
METHODS	Between the 14th and 21st days after hospital discharge , all patients performed a cardiopulmonary exercise testing and a laboratory blood workup .
METHODS	Mean age was similar ( 569 years in the TCC group and 609 years in the control group ) .
METHODS	Patients allocated to the intervention group performed 3 weekly sessions of TCC Beijin style for 12 weeks ( n = 31 ) .
METHODS	The control group participated in 3 weekly sessions of full-body stretching exercises ( n = 30 ) .
RESULTS	After the 12-week study period , participants in the TCC group experienced a significant 14 % increase in Vo2 peak from baseline ( 21.6 5.2 to 24.6 5.2 mL/kg per minute ) , whereas control participants had a nonsignificant 5 % decline in Vo2 peak ( 20.4 5.1 to 19.4 4.4 mL/kg per minute ) .
RESULTS	There was a significant difference between the 2 groups ( P < .0001 ) .
CONCLUSIONS	Tai Chi Chuan practice was associated with an increase in Vo2 peak in patients with a recent MI and may constitute an effective form of cardiac rehabilitation in this patient population .

###25208361
OBJECTIVE	To evaluate the in vitro and in vivo effects of three treatment regimens on dentin permeability and reduction of dentin hypersensitivity ( DH ) .
METHODS	The desensitization treatments were : Gluma Desensitizer PowerGel ( GLU ) , MS Coat One ( MSC ) , and dentin burnishing with fiber-resin burs ( STB ) .
METHODS	A split-chamber device was used to determine the permeability of dentin slices cut from human molars in vitro .
METHODS	Fluid flow through dentin was recorded with a photochemical method after EDTA cleaning , albumin soaking and desensitization treatment ( n = 10 ) .
METHODS	61 study participants with three severely hypersensitive teeth each were enrolled .
METHODS	Sensitivity was determined with an air stimulus before , immediately after treatment , and after 1 , 3 and 6 months , using a verbal rating scale .
RESULTS	From the 61 study participants enrolled , 52 completed the trial .
RESULTS	Permeability at baseline and after albumin soaking was not significantly different .
RESULTS	All treatments produced reduced fluid flow through dentin ( P > 0.05 ) .
RESULTS	All treatments reduced DH significantly ( no or moderate sensitivity ) .
RESULTS	Statistical results revealed significant differences among the treatments ( P = 0.03 ) .
RESULTS	Mann-Whitney comparisons showed GLU , STB < MSC .

###25081735
BACKGROUND	Isotretinoin has been frequently used for acne therapy .
BACKGROUND	However , it has limitation in acceptance because of its adverse effects .
BACKGROUND	Although antihistamine recently revealed to decrease the lipogenesis , evidence is lacking regarding the clinical relevance of antihistamine in the treatment of acne .
OBJECTIVE	To evaluate the clinical efficacy and tolerability of antihistamine as an adjuvant treatment of isotretinoin .
METHODS	Forty patients with moderate acne were included in this randomized , controlled comparative study .
METHODS	Twenty patients were treated with isotretinoin and 20 patients were treated with additional antihistamine , desloratadine .
METHODS	Assessment was made at baseline , after 2 , 4 , 8 and 12 weeks of treatment .
RESULTS	At week 12 , compared with isotretinoin only group , isotretinoin with additional antihistamine group showed more statistically significant decrease in acne lesion counts ( non-inflammatory lesions : 44.8 % vs. 17.8 % ; inflammatory lesions : 55.8 % vs. 22.9 % ; total lesions : 45.6 % vs. 18.7 % ; all P < 0.05 ) .
RESULTS	Significant decrease was also observed in the score of global acne grading system and the measured value of sebum and erythema .
RESULTS	Moreover , acne flare during the treatment occurred less frequently and adverse events of isotretinoin were more tolerable in additional antihistamine group .
CONCLUSIONS	This results provide early evidence that antihistamine has a synergic effect with minimizing the side-effect of isotretinoin , and may be used as an adjuvant treatment of moderate acne .

###24443923
BACKGROUND	Ospemifene is a new oral estrogen receptor agonist/antagonist with tissue-selective effects approved for the treatment of moderate to severe dyspareunia , a symptom of postmenopausal vulvar and vaginal atrophy ( VVA ) .
OBJECTIVE	The aim of the study is to assess ospemifene or lubricant use on the clinical signs of VVA .
METHODS	Subjects in three double-blind , placebo-controlled clinical trials were randomized to ospemifene or placebo .
METHODS	In two of the trials , women were provided nonhormonal lubricants for use as needed , and a preplanned evaluation of the frequency of lubricant use was performed .
METHODS	Additionally , a post hoc placebo group analysis for impact of lubricant use or nonuse on physiologic effects of the percentage of superficial and parabasal cells ( maturation index ) and vaginal pH was conducted .
METHODS	A secondary preplanned end point included visual examination of the vagina ( clinical signs of vaginal dryness , petechiae , pallor , friability , and redness of the mucosa ) comparing change from baseline to end of treatment for the ospemifene 60-mg/day group and vs. placebo .
METHODS	The primary end points in the phase 3 clinical trials included the percentage of superficial cells , parabasal cells , vaginal pH , and most bothersome symptoms compared with placebo .
RESULTS	There was no significant difference in physiologic effects between placebo lubricant users vs. nonusers in either 12-week study .
RESULTS	Compared with baseline , substantially more subjects receiving ospemifene 60mg/day than placebo showed complete resolution of clinical signs of VVA after 12 and 52 weeks of treatment .
CONCLUSIONS	Ospemifene substantially improved clinical signs of VVA .
CONCLUSIONS	Within the placebo group , there was no difference in physiologic effects in lubricant users vs. nonusers .
CONCLUSIONS	Based on gynecologic evaluation of the vagina , benefits were apparent at 12 weeks and sustained for 52 weeks in the ospemifene-treated subjects with significant improvement over placebo .
CONCLUSIONS	In these three clinical trials , in contrast to ospemifene-treated women , placebo subjects who utilized lubricants had no improvement in their underlying vaginal physiology .

###25108027
BACKGROUND	BCG vaccination prevents disseminated tuberculosis in children , but it is contraindicated for persons with human immunodeficiency virus ( HIV ) infection because it can result in severe disease in this population .
BACKGROUND	In tuberculosis-endemic regions , BCG vaccine is administered soon after birth , before in utero and peripartum HIV infection is excluded .
BACKGROUND	We therefore assessed the immunogenicity of BCG vaccine in HIV-exposed infants who received BCG at birth or at 8 weeks of age .
METHODS	HIV-exposed , uninfected infants were randomly assigned to receive BCG vaccination at birth ( the early vaccination arm ) or 8 weeks of age ( the delayed vaccination arm ) .
METHODS	BCG-specific proliferative and intracellular cytokine responses were assessed in 28 infants per arm at 6 , 8 , and 14 weeks of life .
RESULTS	There was no difference in BCG-specific T-cell proliferation between the study arms 6 weeks after vaccination .
RESULTS	However , at 14 weeks of age , the frequency of interferon - expressing CD4 ( + ) T cells and multifunctional BCG-specific responses in the delayed vaccinated arm were significantly higher than those in the early vaccination arm ( P = .021 and P = .011 , respectively ) .
CONCLUSIONS	The immunogenicity of BCG vaccination in HIV-exposed , uninfected infants is not compromised when delayed until 8 weeks of age and results in robust BCG-specific T-cell responses at 14 weeks of age .
CONCLUSIONS	These findings support further evaluation of this modified BCG vaccination strategy for HIV-exposed infants .
BACKGROUND	NCT02062580 .

###24286968
OBJECTIVE	To characterize the association between clinical symptoms and anatomical and functional cerebral deficits in codeine-containing cough syrups ( CCS ) users using voxel-based morphometry and resting state functional connectivity analysis .
METHODS	Participants were 30 CCS users and 30 matched controls .
METHODS	Both groups were scanned using a volumetric three-dimensional fast field echo sequence and a gradient-echo echo-planar imaging sequence .
METHODS	Impulsivity traits of both groups were evaluated with the Barratt Impulsiveness Scale 11 ( BIS 11 ) .
METHODS	Voxel-based morphometry was used to characterize gray matter ( GM ) deficits in CCS users .
METHODS	The clinical significance of regional volume reduction was investigated by evaluating its association with impulsivity in CCS users and with alterations in resting state functional connectivity when brain regions with GM volume reduction were used as seed areas .
RESULTS	Significantly decreased GM volume was observed in CCS users in bilateral ventral medial prefrontal cortex ( vmPFC ) which was related to greater impulsivity in CCS users .
RESULTS	Significantly decreased integration was found in CCS users between the vmPFC and the default mode network .
RESULTS	Also , significantly enhanced functional connectivity was found between the vmPFC and the right insula , and the right dorsal lateral PFC. Negative correlation was observed between BIS total scores , scores for attentional impulsivity and vmPFC-inferior parietal lobe connectivity in CCS users .
CONCLUSIONS	The findings revealed volume loss and aberrant functional organization in vmPFC among CCS users .
CONCLUSIONS	In addition , the decreased vmPFC GM volume and attenuated functional connectivity of the vmPFC-inferior parietal lobe network were associated with clinical higher impulsivity trait in CCS users .

###25022116
OBJECTIVE	To observe the differences in the clinical efficacy on menopausal irritability between acupuncture and medication .
METHODS	Sixty cases of menopausal irritability were randomized into an acupuncture group ( 31 cases ) and a medication group ( 29 cases ) .
METHODS	In the acupuncture group , the warming needling manipulation was applied at the key acupoints such as Hegu ( LI 4 ) and Taichong ( LR 3 ) , once a day , 10 treatments made one session .
METHODS	Totally , 2 sessions were required .
METHODS	In the medication group , 2.5 mg diazepam tablets were prescribed , three times a day , for 23 days totally .
METHODS	The clinical efficacy , the modified Kupperman score and self-rated health measurement scale ( SRHMS ) were compared before and after treatment in the two groups .
METHODS	RESULTS The total effective rate was 87.1 % ( 27/31 ) in the acupuncture group and 82.8 % ( 24/29 ) in the medication group .
METHODS	The difference in the clinical efficacy was not significant between the two groups ( P > 0.05 ) .
METHODS	The modified Kupperman score and SRHMS score were both reduced obviously after treatment in the two groups , indicating the significant difference ( all P < 0.05 ) .
METHODS	The reduction of two scores in the acupuncture group was more obvious than those in the medication group ( Kupperman : 15.23 + / - 6.19 vs 18.45 + / - 5.37 ; SRHMS : 116.29 + / - 38.24 vs 140.34 + / - 42.15 , both P < 0.05 ) .
CONCLUSIONS	The acupuncture and medication are effective in the treatment of menopausal irritability , but the efficacy of warming needling manipulation is better than that of diazepam tablets .

###24251359
BACKGROUND	Edoxaban is a direct oral factor Xa inhibitor with proven antithrombotic effects .
BACKGROUND	The long-term efficacy and safety of edoxaban as compared with warfarin in patients with atrial fibrillation is not known .
METHODS	We conducted a randomized , double-blind , double-dummy trial comparing two once-daily regimens of edoxaban with warfarin in 21,105 patients with moderate-to-high-risk atrial fibrillation ( median follow-up , 2.8 years ) .
METHODS	The primary efficacy end point was stroke or systemic embolism .
METHODS	Each edoxaban regimen was tested for noninferiority to warfarin during the treatment period .
METHODS	The principal safety end point was major bleeding .
RESULTS	The annualized rate of the primary end point during treatment was 1.50 % with warfarin ( median time in the therapeutic range , 68.4 % ) , as compared with 1.18 % with high-dose edoxaban ( hazard ratio , 0.79 ; 97.5 % confidence interval [ CI ] , 0.63 to 0.99 ; P < 0.001 for noninferiority ) and 1.61 % with low-dose edoxaban ( hazard ratio , 1.07 ; 97.5 % CI , 0.87 to 1.31 ; P = 0.005 for noninferiority ) .
RESULTS	In the intention-to-treat analysis , there was a trend favoring high-dose edoxaban versus warfarin ( hazard ratio , 0.87 ; 97.5 % CI , 0.73 to 1.04 ; P = 0.08 ) and an unfavorable trend with low-dose edoxaban versus warfarin ( hazard ratio , 1.13 ; 97.5 % CI , 0.96 to 1.34 ; P = 0.10 ) .
RESULTS	The annualized rate of major bleeding was 3.43 % with warfarin versus 2.75 % with high-dose edoxaban ( hazard ratio , 0.80 ; 95 % CI , 0.71 to 0.91 ; P < 0.001 ) and 1.61 % with low-dose edoxaban ( hazard ratio , 0.47 ; 95 % CI , 0.41 to 0.55 ; P < 0.001 ) .
RESULTS	The corresponding annualized rates of death from cardiovascular causes were 3.17 % versus 2.74 % ( hazard ratio , 0.86 ; 95 % CI , 0.77 to 0.97 ; P = 0.01 ) , and 2.71 % ( hazard ratio , 0.85 ; 95 % CI , 0.76 to 0.96 ; P = 0.008 ) , and the corresponding rates of the key secondary end point ( a composite of stroke , systemic embolism , or death from cardiovascular causes ) were 4.43 % versus 3.85 % ( hazard ratio , 0.87 ; 95 % CI , 0.78 to 0.96 ; P = 0.005 ) , and 4.23 % ( hazard ratio , 0.95 ; 95 % CI , 0.86 to 1.05 ; P = 0.32 ) .
CONCLUSIONS	Both once-daily regimens of edoxaban were noninferior to warfarin with respect to the prevention of stroke or systemic embolism and were associated with significantly lower rates of bleeding and death from cardiovascular causes .
CONCLUSIONS	( Funded by Daiichi Sankyo Pharma Development ; ENGAGE AF-TIMI 48 ClinicalTrials.gov number , NCT00781391 . )

###24387642
BACKGROUND	Interface choice is crucial for non-invasive ventilation ( NIV ) success .
BACKGROUND	We compared a new interface , the helmet next ( HN ) , with the facial mask ( FM ) and the standard helmet ( HS ) in twelve healthy volunteers .
METHODS	In this study , five NIV trials were randomly applied , preceded and followed by a trial of unassisted spontaneous breathing ( SB ) .
METHODS	Baseline settings , for example , 5 cmH2O of both inspiratory pressure support ( PS ) and positive end-expiratory pressure ( PEEP ) , were applied through FM , HS and HN , while increased settings ( PS and PEEP of 8 cmH2O ) were only applied through HS and HN .
METHODS	We measured flow , airway , esophageal and gastric pressures , and calculated inspiratory effort indexes and trigger delays .
METHODS	Comfort was assessed with a visual-analog-scale .
RESULTS	We found that FM , HS and HN at baseline settings were not significantly different with respect to inspiratory effort indexes and comfort .
RESULTS	Inspiratory trigger delay and time of synchrony ( TI , synchrony ) were significantly improved by FM compared to both helmets , whereas expiratory trigger delay was shorter with FM , as opposed to HS only .
RESULTS	HN at increased settings performed better than FM in decreasing inspiratory effort measured by pressure-time product of transdiaphragmatic pressure ( PTPdi ) / breath ( 10.79.9 versus 17.011.0 cmH2Os ) , and PTPdi/min ( 12896 versus 20481 cmH2Os/min ) , and PTPdi/L ( 12.69.9 versus 30.216.8 cmH2Os/L ) .
RESULTS	TI , synchrony was inferior between HN and HS at increased settings and FM .
CONCLUSIONS	HN might hold some advantages with respect to interaction and synchrony between subject and ventilator , but studies on patients are needed to confirm these findings .
BACKGROUND	ClinicalTrials.gov NCT01610960 .

###25590215
BACKGROUND	The benefits of prophylactic central compartment lymph node dissection ( pCCND ) in papillary thyroid cancer ( PTC ) are still under investigation .
BACKGROUND	This treatment seems to reduce PTC recurrence/mortality rates but has a higher risk of surgical complications .
BACKGROUND	The lack of prospective randomized trials does not allow definitive recommendations .
BACKGROUND	The aim of this prospective randomized controlled study was to evaluate the clinical advantages and disadvantages of pCCND .
METHODS	A total of 181 patients with PTC without evidence of preoperative/intraoperative lymph node metastases ( cN0 ) were randomly assigned to either Group A ( n = 88 ) and treated with total thyroidectomy ( TTx ) or Group B ( n = 93 ) and treated with TTx + pCCND .
RESULTS	After 5 years of followup , no difference was observed in the outcome of the two groups .
RESULTS	However , a higher percentage of Group A were treated with a higher number of ( 131 ) I courses ( P = .002 ) , whereas a higher prevalence of permanent hypoparathyroidism was observed in Group B ( P = .02 ) .
RESULTS	No preoperative predictors of central compartment lymph node metastases ( N1a ) were identified .
RESULTS	Only three patients were upstaged , and the therapeutic strategy changed in only one case .
CONCLUSIONS	cN0 patients with PTC treated either with TTx or TTx + pCCND showed a similar outcome .
CONCLUSIONS	One advantage of TTx + pCCND was a reduced necessity to repeat ( 131 ) I treatments , but the disadvantage was a higher prevalence of permanent hypoparathyroidism .
CONCLUSIONS	Almost 50 % of patients with PTC had micrometastatic lymph nodes in the central compartment , but none of the presurgical features analyzed , including BRAF mutation , was able to predict their presence ; moreover , to be aware of their presence does not seem to have any effect on the outcome .

###25935581
BACKGROUND	The cause of death in patients with chronic kidney disease ( CKD ) varies with CKD severity , but variation has not been quantified .
METHODS	Retrospective analysis of prospective randomized clinical trial .
METHODS	We analyzed 4,038 individuals with anemia and diabetic CKD from TREAT , a randomized trial comparing darbepoetin alfa and placebo .
METHODS	Baseline estimated glomerular filtration rate ( eGFR ) and protein-creatinine ratio ( PCR ) .
RESULTS	Cause of death as adjudicated by a blinded committee .
RESULTS	Median eGFR and PCR ranged from 20.6 mL/min/1 .73 m ( 2 ) and 4.1 g/g in quartile 1 ( Q1 ) to 47.0 mL/min/1 .73 m ( 2 ) and 0.1 g/g in Q4 ( P < 0.01 ) .
RESULTS	Of 806 deaths , 441 , 298 , and 67 were due to cardiovascular ( CV ) , non-CV , and unknown causes , respectively .
RESULTS	Cumulative CV mortality at 3 years was higher with lower eGFR ( Q1 , 15.5 % ; Q2 , 11.1 % ; Q3 , 11.2 % ; Q4 , 10.3 % ; P < 0.001 ) or higher PCR ( Q1 , 15.2 % ; Q2 , 12.3 % ; Q3 , 11.7 % ; Q4 , 9.0 % ; P < 0.001 ) .
RESULTS	Similarly , non-CV mortality was higher with lower eGFR ( Q1 , 12.7 % ; Q2 , 8.4 % ; Q3 , 6.7 % ; Q4 , 6.1 % ; P < 0.001 ) or higher PCR ( Q1 , 10.3 % ; Q2 , 7.9 % ; Q3 , 9.4 % ; Q4 , 6.4 % ; P = 0.01 ) .
RESULTS	Sudden death was 1.7-fold higher with lower eGFR ( P = 0.04 ) and 2.1-fold higher with higher PCR ( P < 0.001 ) .
RESULTS	Infection-related mortality was 3.3-fold higher in the lowest eGFR quartile ( P < 0.001 ) and 2.8-fold higher in the highest PCR quartile ( P < 0.02 ) .
RESULTS	The overall proportion of CV and non-CV deaths was not significantly different across eGFR or PCR quartiles .
CONCLUSIONS	Results may not be generalizable to nondiabetic CKD or diabetic CKD in the absence of anemia .
CONCLUSIONS	Measured GFR was not available .
CONCLUSIONS	In diabetic CKD , both lower baseline GFR and higher PCR are associated with higher CV and non-CV mortality rates , particularly from sudden death and infection .
CONCLUSIONS	Efforts to improve outcomes should focus on CV disease and early diagnosis and treatment of infection .

###24882225
OBJECTIVE	A culturally focused psychiatric ( CFP ) consultation service was implemented to increase engagement in mental health care and reduce depressive symptoms among adult Latino primary care patients .
OBJECTIVE	The aim of this study was to assess preliminary efficacy of the CFP consultation service to reduce depressive symptoms .
METHODS	In a randomized controlled study , primary care clinics were randomly selected to provide either the two-session CFP intervention or enhanced usual care .
METHODS	For CFP intervention participants , study clinicians ( psychologists or psychiatrists ) provided a psychiatric assessment , psychoeducation , cognitive-behavioral tools , and tailored treatment recommendations ; primary care providers were provided a consultation summary .
METHODS	Depressive symptoms ( as measured by the Quick Inventory of Depressive Symptomatology-Self Rated [ QIDS-SR ] ) were assessed at baseline and six-month follow-up .
METHODS	Multiple regression analysis was conducted to evaluate whether CFP intervention participants showed greater improvement in depressive symptoms at follow-up , with control for baseline depression , clinic site , and significant covariates .
RESULTS	Participants ( N = 118 ) were primarily Spanish-monolingual speakers ( 64 % ) .
RESULTS	Although depressive symptoms remained in the moderate range for both groups from baseline to six months , symptom reduction was greater among CFP intervention participants ( meanSD change in QIDS-SR score = 3.465.48 ) than those in usual care ( change = .094.43 ) .
RESULTS	The final multiple regression model indicated that participation in the CFP intervention predicted lower depressive symptoms at follow-up ( unstandardized beta = -3.09 , p = .008 ) , independent of baseline depressive symptoms , clinic site , age , gender , and employment status .
CONCLUSIONS	Results suggest that Latinos experiencing depressive symptoms may benefit from a short-term CFP consultation .
CONCLUSIONS	Findings also support the integration of psychiatric interventions for Latinos in the primary care setting .

###24521106
BACKGROUND	Sentinel-node biopsy , a minimally invasive procedure for regional melanoma staging , was evaluated in a phase 3 trial .
METHODS	We evaluated outcomes in 2001 patients with primary cutaneous melanomas randomly assigned to undergo wide excision and nodal observation , with lymphadenectomy for nodal relapse ( observation group ) , or wide excision and sentinel-node biopsy , with immediate lymphadenectomy for nodal metastases detected on biopsy ( biopsy group ) .
METHODS	Results No significant treatment-related difference in the 10-year melanoma-specific survival rate was seen in the overall study population ( 20.8 % with and 79.2 % without nodal metastases ) .
METHODS	Mean ( SE ) 10-year disease-free survival rates were significantly improved in the biopsy group , as compared with the observation group , among patients with intermediate-thickness melanomas , defined as 1.20 to 3.50 mm ( 71.3 1.8 % vs. 64.7 2.3 % ; hazard ratio for recurrence or metastasis , 0.76 ; P = 0.01 ) , and those with thick melanomas , defined as > 3.50 mm ( 50.7 4.0 % vs. 40.5 4.7 % ; hazard ratio , 0.70 ; P = 0.03 ) .
METHODS	Among patients with intermediate-thickness melanomas , the 10-year melanoma-specific survival rate was 62.1 4.8 % among those with metastasis versus 85.1 1.5 % for those without metastasis ( hazard ratio for death from melanoma , 3.09 ; P < 0.001 ) ; among patients with thick melanomas , the respective rates were 48.0 7.0 % and 64.6 4.9 % ( hazard ratio , 1.75 ; P = 0.03 ) .
METHODS	Biopsy-based management improved the 10-year rate of distant disease-free survival ( hazard ratio for distant metastasis , 0.62 ; P = 0.02 ) and the 10-year rate of melanoma-specific survival ( hazard ratio for death from melanoma , 0.56 ; P = 0.006 ) for patients with intermediate-thickness melanomas and nodal metastases .
METHODS	Accelerated-failure-time latent-subgroup analysis was performed to account for the fact that nodal status was initially known only in the biopsy group , and a significant treatment benefit persisted .
CONCLUSIONS	Biopsy-based staging of intermediate-thickness or thick primary melanomas provides important prognostic information and identifies patients with nodal metastases who may benefit from immediate complete lymphadenectomy .
CONCLUSIONS	Biopsy-based management prolongs disease-free survival for all patients and prolongs distant disease-free survival and melanoma-specific survival for patients with nodal metastases from intermediate-thickness melanomas .
CONCLUSIONS	( Funded by the National Cancer Institute , National Institutes of Health , and the Australia and New Zealand Melanoma Trials Group ; ClinicalTrials.gov number , NCT00275496 . )

###25100080
BACKGROUND	Few studies have evaluated the effects of rabeprazole on low-dose aspirin ( LDA ) - induced gastroduodenal injuries .
OBJECTIVE	To conduct a randomised , double-blind , triple-dummy , active-controlled , multicentre trial , named the PLANETARIUM study , to assess the efficacy , dose-response relationship and safety of rabeprazole for peptic ulcer recurrence in Japanese patients on long-term LDA therapy .
METHODS	Eligible patients had a history of endoscopically confirmed peptic ulcers and were receiving long-term LDA ( 81 or 100 mg/day ) therapy for cardiovascular or cerebrovascular protection .
METHODS	Subjects were randomly segregated into three groups receiving rabeprazole 10 mg once daily ( standard dose in Japan ) , rabeprazole 5 mg once daily , or teprenone ( geranylgeranylacetone ; mucosal protective agent commercially available in Japan ) 50 mg three times per day as an active control .
METHODS	The primary endpoint was recurrence of peptic ulcers over 24 weeks .
RESULTS	Among 472 randomised subjects , 452 subjects ( n = 151 , 150 , 151 , respectively ) constituted the full analysis set .
RESULTS	The cumulative recurrence rates of peptic ulcers over 24 weeks in the 10 - and 5-mg rabeprazole groups were 1.4 % and 2.8 % , respectively , both of which were significantly lower than that in the teprenone group ( 21.7 % ) .
RESULTS	The cumulative occurrence rate of bleeding ulcers over 24 weeks in the teprenone group was 4.6 % , while bleeding ulcers were not observed in the 10 - or 5-mg rabeprazole groups .
RESULTS	Rabeprazole was well tolerated at both doses .
CONCLUSIONS	Rabeprazole prevents the recurrence of peptic ulcers with no evidence of a major dose-response effect in subjects on low-dose aspirin therapy .

###24836310
BACKGROUND	Nintedanib ( formerly known as BIBF 1120 ) is an intracellular inhibitor that targets multiple tyrosine kinases .
BACKGROUND	A phase 2 trial suggested that treatment with 150 mg of nintedanib twice daily reduced lung-function decline and acute exacerbations in patients with idiopathic pulmonary fibrosis .
METHODS	We conducted two replicate 52-week , randomized , double-blind , phase 3 trials ( INPULSIS-1 and INPULSIS-2 ) to evaluate the efficacy and safety of 150 mg of nintedanib twice daily as compared with placebo in patients with idiopathic pulmonary fibrosis .
METHODS	The primary end point was the annual rate of decline in forced vital capacity ( FVC ) .
METHODS	Key secondary end points were the time to the first acute exacerbation and the change from baseline in the total score on the St. George 's Respiratory Questionnaire , both assessed over a 52-week period .
RESULTS	A total of 1066 patients were randomly assigned in a 3:2 ratio to receive nintedanib or placebo .
RESULTS	The adjusted annual rate of change in FVC was -114.7 ml with nintedanib versus -239.9 ml with placebo ( difference , 125.3 ml ; 95 % confidence interval [ CI ] , 77.7 to 172.8 ; P < 0.001 ) in INPULSIS-1 and -113.6 ml with nintedanib versus -207.3 ml with placebo ( difference , 93.7 ml ; 95 % CI , 44.8 to 142.7 ; P < 0.001 ) in INPULSIS-2 .
RESULTS	In INPULSIS-1 , there was no significant difference between the nintedanib and placebo groups in the time to the first acute exacerbation ( hazard ratio with nintedanib , 1.15 ; 95 % CI , 0.54 to 2.42 ; P = 0.67 ) ; in INPULSIS-2 , there was a significant benefit with nintedanib versus placebo ( hazard ratio , 0.38 ; 95 % CI , 0.19 to 0.77 ; P = 0.005 ) .
RESULTS	The most frequent adverse event in the nintedanib groups was diarrhea , with rates of 61.5 % and 18.6 % in the nintedanib and placebo groups , respectively , in INPULSIS-1 and 63.2 % and 18.3 % in the two groups , respectively , in INPULSIS-2 .
CONCLUSIONS	In patients with idiopathic pulmonary fibrosis , nintedanib reduced the decline in FVC , which is consistent with a slowing of disease progression ; nintedanib was frequently associated with diarrhea , which led to discontinuation of the study medication in less than 5 % of patients .
CONCLUSIONS	( Funded by Boehringer Ingelheim ; INPULSIS-1 and INPULSIS-2 ClinicalTrials.gov numbers , NCT01335464 and NCT01335477 . )

###25246602
BACKGROUND	Approximately 30 % of children younger than 3 years experience at least 1 episode of wheezing .
BACKGROUND	Antiasthmatic medication is routinely prescribed , but its effectiveness remains unclear .
BACKGROUND	Our study was aimed to evaluate the effect of anti-inflammatory treatment on frequency and severity of preschool wheeze episodes ( PWEs ) .
METHODS	Children aged 6 to 36 months with the first up to the third PWE were randomly assigned to receive montelukast , fluticasone , or no treatment for 12 weeks .
METHODS	The outcome measures were the number of PWEs , the number of hospitalizations due to PWE , and the severity of respiratory symptoms .
METHODS	results : There were no significant differences in outcome measures between the groups .
METHODS	However , tobacco-exposed children treated with fluticasone had significantly fewer PWEs ( P = .01 ) .
CONCLUSIONS	Neither montelukast nor fluticasone has proven effective in the prevention of PWE recurrence .
CONCLUSIONS	Children of smoking parents may benefit from fluticasone treatment after PWE .
CONCLUSIONS	This observation requires confirmation in larger studies .

###24674827
BACKGROUND	The efficacy of antibiotic prophylaxis for the prevention of surgical-site infection ( SSI ) after open tension-free inguinal hernia repair remains controversial .
METHODS	A double-blind , randomized , placebo-controlled trial was conducted .
METHODS	Patients who underwent elective open mesh-plug hernia repair were eligible for randomization .
METHODS	In the antibiotic prophylaxis group , 1.0 g cefazolin was intravenously administrated 30 minutes before the incision .
METHODS	In the placebo group , an equal volume of sterile saline was administered .
METHODS	The primary end point was the incidence of SSI .
RESULTS	A total of 200 patients were enrolled .
RESULTS	SSI developed in 2 of 100 patients ( 2 % ) in the antibiotic prophylaxis group and 13 of 100 patients ( 13 % ) in the placebo group , indicating a significant difference between the 2 groups ( relative risk ratio , 0.25 ; 95 % confidence interval , 0.070 to 0.92 ; P = .003 ) .
RESULTS	Other complications occurred in 23 patients : 7 ( 7 % ) in the antibiotic prophylaxis group and 16 ( 16 % ) in the placebo group ( P = .046 ) .
CONCLUSIONS	This study indicates that antibiotic prophylaxis is effective for the prevention of SSI after open mesh-plug hernia repair .

###25680597
BACKGROUND	Postoperative radiation therapy for stage I endometrial cancer improves locoregional control but is without survival benefit .
BACKGROUND	To facilitate treatment decision support for individual patients , accurate statistical models to predict locoregional relapse ( LRR ) , distant relapse ( DR ) , overall survival ( OS ) , and disease-free survival ( DFS ) are required .
METHODS	Clinical trial data from the randomized Post Operative Radiation Therapy for Endometrial Cancer ( PORTEC-1 ; N = 714 patients ) and PORTEC-2 ( N = 427 patients ) trials and registered group ( grade 3 and deep invasion , n = 99 ) were pooled for analysis ( N = 1240 ) .
METHODS	For most patients ( 86 % ) pathology review data were available ; otherwise original pathology data were used .
METHODS	Trial variables which were clinically relevant and eligible according to data constraints were age , stage , given treatment ( pelvic external beam radiation therapy ( EBRT ) , vaginal brachytherapy ( VBT ) , or no adjuvant treatment , FIGO histological grade , depth of invasion , and lymph-vascular invasion ( LVSI ) .
METHODS	Multivariate analyses were based on Cox proportional hazards regression model .
METHODS	Predictors were selected based on a backward elimination scheme .
METHODS	Model results were expressed by the c-index ( 0.5-1 .0 ; random to perfect prediction ) .
METHODS	Two validation sets ( n = 244 and 291 patients ) were used .
RESULTS	Accuracy of the developed models was good , with training accuracies between 0.71 and 0.78 .
RESULTS	The nomograms validated well for DR ( 0.73 ) , DFS ( 0.69 ) , and OS ( 0.70 ) , but validation was only fair for LRR ( 0.59 ) .
RESULTS	Ranking of variables as to their predictive power showed that age , tumor grade , and LVSI were highly predictive for all outcomes , and given treatment for LRR and DFS .
RESULTS	The nomograms were able to significantly distinguish low - from high-probability patients for these outcomes .
CONCLUSIONS	The nomograms are internally validated and able to accurately predict long-term outcome for endometrial cancer patients with observation , pelvic EBRT , or VBT after surgery .
CONCLUSIONS	These models facilitate decision support in daily clinical practice and can be used for patient counseling and shared decision making , selecting patients who benefit most from adjuvant treatment , and generating new hypotheses .

###25456755
BACKGROUND	The detailed mechanism of plaque stabilization by statin therapy is not fully understood .
OBJECTIVE	The aim of this study was to assess the effect of lipid-lowering therapy with 20 mg/day of atorvastatin versus 5 mg/day of atorvastatin on fibrous cap thickness in coronary atherosclerotic plaques by using optical coherence tomography ( OCT ) .
METHODS	Seventy patients with unstable angina pectoris and untreated dyslipidemia were randomized to either 20mg/day or 5 mg/day of atorvastatin therapy .
METHODS	OCT was performed to assess intermediate nonculprit lesions at baseline and 12-month follow-up .
RESULTS	Serum low-density lipoprotein cholesterol level was significantly lower during therapy with 20 mg/day compared with 5 mg/day of atorvastatin ( 69 mg/dl vs. 78 mg/dl ; p = 0.039 ) .
RESULTS	The increase in fibrous cap thickness was significantly greater with 20 mg/day compared with 5 mg/day of atorvastatin ( 69 % vs. 17 % ; p < 0.001 ) .
RESULTS	The increase in fibrous cap thickness correlated with the decrease in serum levels of low-density lipoprotein cholesterol ( R = -0.450 ; p < 0.001 ) , malondialdehyde-modified low-density lipoprotein ( R = -0.283 ; p = 0.029 ) , high-sensitivity C-reactive protein ( R = -0.276 ; p = 0.033 ) , and matrix metalloproteinase-9 ( R = -0.502 ; p < 0.001 ) , and the decrease in grade of OCT-derived macrophages ( R = -0.415 ; p = 0.003 ) .
CONCLUSIONS	Atorvastatin therapy at 20 mg/day provided a greater increase in fibrous cap thickness in coronary plaques compared with 5 mg/day of atorvastatin .
CONCLUSIONS	The increase of fibrous cap was associated with the decrease in serum atherogenic lipoproteins and inflammatory biomarkers during atorvastatin therapy .
CONCLUSIONS	( Effect of Atorvastatin Therapy on Fibrous Cap Thickness in Coronary Atherosclerotic Plaque as Assessed by Optical Coherence Tomography : The EASY-FIT Study ; NCT00700037 ) .

###25168768
BACKGROUND	In patients treated with oral anticoagulants , subcutaneous injections of anti-tetanus vaccine are usually recommended to reduce the risk of bleeding , although the effectiveness of the vaccine has only been proven for intramuscular injection .
BACKGROUND	The objective of this study was to compare the safety and efficacy of intramuscular and subcutaneous injections of tetanus-diphtheria vaccine in patients treated with oral anticoagulants .
METHODS	We present a prospective , double blinded , clinical trial comparing two groups of patients with oral anticoagulants : one group was administered tetanus-diphtheria vaccine by intramuscular injection , while the other was administered the same vaccine by subcutaneous injection .
METHODS	Allocation to each group was randomized and the duration of the study was six years .
METHODS	all patients treated with oral anticoagulants , who had been administered with at least one dose of vaccine , at 15 Health Centres in Vigo ( Spain ) , and who agreed to participate in the study .
METHODS	The sample size was 115 patients in each group .
METHODS	The main variables for the safety analysis were the measurement of the brachial diameter , the appearance of basic injuries at the vaccine administration site , the appearance of pain and systemic reactions .
METHODS	The variable used for the efficacy analysis was a significant increase in the titres of anti-tetanus toxoid antibodies.An Intention-to-treat analysis will be performed .
METHODS	Details will be classified according to the administration route , while within each group a 3-tiered stratification will be defined by the administered number of doses .
METHODS	As a measure of association , relative risk will be estimated ; the reduction of relative risk will also measured .
METHODS	For safety and to control the confounder effect , a logistic regression analysis will be carried out .
METHODS	As a measure of impact the reduction of absolute risk in relation to the total number of patients to be treated and the Number Needed to Treat will be estimated.CONSORT 2010 guidelines were applied for reporting parallel group randomised trials .
CONCLUSIONS	The most significant difficulties on the project are related to the large number of participating centres , required to obtain a viable study population sample size , and the coordination given the scattering of the centres and researchers .
BACKGROUND	ISRCTN69942081 .

###25005937
OBJECTIVE	Insulin regulates the GH-IGF1 axis .
OBJECTIVE	Insulin analogs differ from human insulin in receptor affinity and possibly liver accessibility .
OBJECTIVE	Therefore , we compared the GH-IGF1 axis response with human NPH insulin , insulin detemir , and insulin glargine in patients with type 1 diabetes ( T1D ) .
METHODS	A total of 17 patients ( seven were women ) with T1D ( age of 42 ( 24-63 ) years ( mean and range ) , BMI of 24.7 ( 19.5-28 .3 ) kg/m ( 2 ) , HbA1c of 7.2 ( 6.3-8 .0 ) % ( 55 ( 45-64 ) mmol/mol ) , T1D duration of 26 ( 8-45 ) years ) were studied using a randomized , three-period crossover design .
METHODS	Patients received s.c. injections of equal , individual doses of NPH , detemir , and glargine at 1800h .
METHODS	Plasma glucose , serum total IGF1 , bioactive IGF , IGF-binding protein ( IGFBPs ) , and GH were measured hourly for 14h post-injection .
RESULTS	When compared with the area under the curve ( AUC ) following NPH and glargine , detemir resulted in the lowest 6-14h AUC ( mean and range ) of IGFBP1 ( 1518 ( 1280-1800 ) ) vs 1621 ( 1367-1922 ) vs 1020 ( 860-1210 ) g/lh ) and GH ( 17.1 ( 14.1-20 .6 ) vs 15.4 ( 12.7-18 .6 ) vs 10.2 ( 8.5-12 .3 ) g/lh ) , but in the highest AUC of bioactive IGF ( 3.8 ( 3.5-4 .2 ) vs 3.7 ( 3.4-4 .0 ) vs 4.4 ( 4.1-4 .8 ) g/lh ) ( all P < 0.01 ) .
RESULTS	These differences were unrelated to plasma glucose .
RESULTS	By contrast , profiles of total IGF1 , IGFBP2 , and IGFBP3 were comparable .
CONCLUSIONS	Independent of plasma glucose , a single dose of detemir caused larger suppression in serum IGFBP1 than NPH and glargine , whereas bioactive IGF was higher , thereby explaining the lower GH levels .
CONCLUSIONS	Thus , detemir appears to be more liver specific than NPH insulin and glargine .

###25399552
BACKGROUND	Nivolumab was associated with higher rates of objective response than chemotherapy in a phase 3 study involving patients with ipilimumab-refractory metastatic melanoma .
BACKGROUND	The use of nivolumab in previously untreated patients with advanced melanoma has not been tested in a phase 3 controlled study .
METHODS	We randomly assigned 418 previously untreated patients who had metastatic melanoma without a BRAF mutation to receive nivolumab ( at a dose of 3 mg per kilogram of body weight every 2 weeks and dacarbazine-matched placebo every 3 weeks ) or dacarbazine ( at a dose of 1000 mg per square meter of body-surface area every 3 weeks and nivolumab-matched placebo every 2 weeks ) .
METHODS	The primary end point was overall survival .
RESULTS	At 1 year , the overall rate of survival was 72.9 % ( 95 % confidence interval [ CI ] , 65.5 to 78.9 ) in the nivolumab group , as compared with 42.1 % ( 95 % CI , 33.0 to 50.9 ) in the dacarbazine group ( hazard ratio for death , 0.42 ; 99.79 % CI , 0.25 to 0.73 ; P < 0.001 ) .
RESULTS	The median progression-free survival was 5.1 months in the nivolumab group versus 2.2 months in the dacarbazine group ( hazard ratio for death or progression of disease , 0.43 ; 95 % CI , 0.34 to 0.56 ; P < 0.001 ) .
RESULTS	The objective response rate was 40.0 % ( 95 % CI , 33.3 to 47.0 ) in the nivolumab group versus 13.9 % ( 95 % CI , 9.5 to 19.4 ) in the dacarbazine group ( odds ratio , 4.06 ; P < 0.001 ) .
RESULTS	The survival benefit with nivolumab versus dacarbazine was observed across prespecified subgroups , including subgroups defined by status regarding the programmed death ligand 1 ( PD-L1 ) .
RESULTS	Common adverse events associated with nivolumab included fatigue , pruritus , and nausea .
RESULTS	Drug-related adverse events of grade 3 or 4 occurred in 11.7 % of the patients treated with nivolumab and 17.6 % of those treated with dacarbazine .
CONCLUSIONS	Nivolumab was associated with significant improvements in overall survival and progression-free survival , as compared with dacarbazine , among previously untreated patients who had metastatic melanoma without a BRAF mutation .
CONCLUSIONS	( Funded by Bristol-Myers Squibb ; CheckMate 066 ClinicalTrials.gov number , NCT01721772 . )

###24330669
BACKGROUND	Maaori are the Indigenous people of New Zealand and do not enjoy the same oral health status as the non-Indigenous majority .
BACKGROUND	To overcome oral health disparities , the life course approach affords a valid foundation on which to develop a process that will contribute to the protection of the oral health of young infants .
BACKGROUND	The key to this process is the support that could be provided to the parents or care givers of Maaori infants during the pregnancy of the mother and the early years of the child .
BACKGROUND	This study seeks to determine whether implementing a kaupapa Maaori ( Maaori philosophical viewpoint ) in an early childhood caries ( ECC ) intervention reduces dental disease burden among Maaori children .
BACKGROUND	The intervention consists of four approaches to prevent early childhood caries : dental care provided during pregnancy , fluoride varnish application to the teeth of children , motivational interviewing , and anticipatory guidance .
METHODS	The participants are Maaori women who are expecting a child and who reside within the Maaori tribal area of Waikato-Tainui .
METHODS	This randomised-control trial will be undertaken utilising the principles of kaupapa Maaori research , which encompasses Maaori leadership , Maaori relationships , Maaori customary practices , etiquette and protocol .
METHODS	Participants will be monitored through clinical and self-reported information collected throughout the ECC intervention .
METHODS	Self-report information will be collected in a baseline questionnaire during pregnancy and when children are aged 24 and 36 months .
METHODS	Clinical oral health data will be collected during standardised examinations at ages 24 and 36 months by calibrated dental professionals .
METHODS	All participants receive the ECC intervention benefits , with the intervention delayed by 24 months for participants who are randomised to the control-delayed arm .
CONCLUSIONS	The development and evaluation of oral health interventions may produce evidence that supports the application of the principles of kaupapa Maaori research in the research processes .
CONCLUSIONS	This study will assess an ECC intervention which could provide a meaningful approach for Maaori for the protection and maintenance of oral health for Maaori children and their family , thus reducing oral health disparities .
BACKGROUND	Australia and New Zealand Clinical Trials Register ( ANZCTR ) : ACTRN12611000111976 .

###24992418
BACKGROUND	The surgical Apgar score ( SAS ) can predict 30-day major complications or death after surgery .
BACKGROUND	Studies have validated the score in different patient populations and suggest it should be used to objectively guide postoperative care .
BACKGROUND	We aimed to see whether using the SAS in a decisive approach in a future randomised controlled trial ( RCT ) would be likely to demonstrate an effect on postoperative care and clinical outcome .
METHODS	A total of 143 adults undergoing general/vascular surgery in 9 National Health Service hospitals were recruited to a pilot single blinded RCT and the data for 139 of these were analysed .
METHODS	Participants were randomised to a control group with standard postoperative care or to an intervention group with care influenced ( but not mandated ) by the SAS ( decisive approach ) .
METHODS	The notional primary outcome was 30-day major complications or death .
RESULTS	Incidence of major complications was similar in both groups ( control : 20/69 [ 29 % ] , intervention : 23/70 [ 33 % ] , p = 0.622 ) .
RESULTS	Immediate admissions to the critical care unit was higher in the intervention group , especially in the SAS 0-4 subgroup ( 4/6 vs 2/7 ) although this was not statistically significant ( p = 0.310 ) .
RESULTS	Validity was also confirmed in area under the curve ( AUC ) analysis ( AUC : 0.77 ) .
CONCLUSIONS	This pilot study found that a future RCT to investigate the effect of using the SAS in a decisive approach may demonstrate a difference in postoperative care .
CONCLUSIONS	However , significant changes to the design are needed if differences in clinical outcome are to be achieved reliably .
CONCLUSIONS	These would include a wider array of postoperative interventions implemented using a quality improvement approach in a stepped wedge cluster design with blinded collection of outcome data .

###26074402
OBJECTIVE	To investigate if patients with thyroid carcinoma having N1a disease are at the same risk with N1b using the collective of the well-defined European prospective Multicentre Study Differentiated Thyroid Cancer ( MSDS ) .
METHODS	Overall ( OS ) and event free survival ( EFS ) were calculated .
METHODS	Cox multivariable regression analysis was performed in order to calculate Hazard ratios ( HR ) .
RESULTS	EFS was significantly decreased only in patients with N1b metastasis as compared to N0 patients and became worse when N1a was concomitantly affected .
RESULTS	A superior survival in favor of N1a patients as compared to N1b patients with regard to EFS was also observed .
RESULTS	The patients having N1a disease showed no differences in the EFS as compared to N0 .
RESULTS	OS did not differ significantly in any of the groups .
RESULTS	There was an increased HR for events with regards to histology , T-stage , tumor size , UICC stage and cervical lymph node metastasis .
RESULTS	Tumor size showed a significantly increased risk for OS .
CONCLUSIONS	Patients with pT3b and pT4a tumors with N1b are of higher risk for relapse , albeit not affecting overall survival .
CONCLUSIONS	Patients with N1a are of no higher risk .
CONCLUSIONS	The risk stratification of these patients may be adapted accordingly .

###24280722
OBJECTIVE	A single randomized trial established lobectomy as the standard of care for the surgical treatment of early-stage non-small cell lung cancer .
OBJECTIVE	Recent advances in imaging/staging modalities and detection of smaller tumors have once again rekindled interest in sublobar resection for early-stage disease .
OBJECTIVE	The objective of this study was to compare lung cancer survival in patients with non-small cell lung cancer with a diameter of 30 mm or less with clinical stage 1 disease who underwent lobectomy or sublobar resection .
METHODS	We identified 347 patients diagnosed with lung cancer who underwent lobectomy ( n = 294 ) or sublobar resection ( n = 53 ) for non-small cell lung cancer manifesting as a solid nodule in the International Early Lung Cancer Action Program from 1993 to 2011 .
METHODS	Differences in the distribution of the presurgical covariates between sublobar resection and lobectomy were assessed using unadjusted P values determined by logistic regression analysis .
METHODS	Propensity scoring was performed using the same covariates .
METHODS	Differences in the distribution of the same covariates between sublobar resection and lobectomy were assessed using adjusted P values determined by logistic regression analysis with adjustment for the propensity scores .
METHODS	Lung cancer-specific survival was determined by the Kaplan-Meier method .
METHODS	Cox survival regression analysis was used to compare sublobar resection with lobectomy , adjusted for the propensity scores , surgical , and pathology findings , when adjusted and stratified by propensity quintiles .
RESULTS	Among 347 patients , 10-year Kaplan-Meier for 53 patients treated by sublobar resection compared with 294 patients treated by lobectomy was 85 % ( 95 % confidence interval , 80-91 ) versus 86 % ( confidence interval , 75-96 ) ( P = .86 ) .
RESULTS	Cox survival analysis showed no significant difference between sublobar resection and lobectomy when adjusted for propensity scores or when using propensity quintiles ( P = .62 and P = .79 , respectively ) .
RESULTS	For those with cancers 20 mm or less in diameter , the 10-year rates were 88 % ( 95 % confidence interval , 82-93 ) versus 84 % ( 95 % confidence interval , 73-96 ) ( P = .45 ) , and Cox survival analysis showed no significant difference between sublobar resection and lobectomy using either approach ( P = .42 and P = .52 , respectively ) .
CONCLUSIONS	Sublobar resection and lobectomy have equivalent survival for patients with clinical stage IA non-small cell lung cancer in the context of computed tomography screening for lung cancer .

###24508531
OBJECTIVE	To assess the effects of postural rehabilitation ( PR ) on trunk asymmetry and balance , with and without Kinesio taping ( KT ) of the back muscles as additional treatment , in patients with Parkinson 's disease ( PD ) who have postural disorders .
METHODS	Single-blind , randomized controlled trial with 1-month follow-up .
METHODS	Ambulatory care in referral center .
METHODS	Patients ( N = 20 ) with PD showing postural abnormalities of the trunk , in the sagittal and/or coronal plane .
METHODS	Four weeks of patient-tailored proprioceptive and tactile stimulation , combined with stretching and postural reeducation , was provided to 13 subjects ( PR group ) , while 7 received no treatment ( control group ) .
METHODS	Six of the 13 subjects receiving PR also had KT strips applied to their trunk muscles , according to the features of their postural abnormalities .
METHODS	Berg Balance Scale , Timed Up and Go , and degrees of trunk bending in the sagittal and coronal planes were assessed at the enrollment ( t0 ) , 1 month later ( t1 ) , and 2 months later ( t2 ) .
RESULTS	At t1 , all treated patients showed a significant improvement in trunk posture in both the sagittal ( P = .002 ) and coronal planes ( P = .01 ) , compared with baseline .
RESULTS	Moreover , they showed an improvement in measures of gait and balance ( P < .01 ) .
RESULTS	Benefits persisted at t2 for all measures , except lateral trunk bend .
RESULTS	No differences were found when comparing the PR and KT groups .
CONCLUSIONS	The combination of active posture correction and trunk movements , muscle stretching , and proprioceptive stimulation may usefully impact PD axial symptoms .
CONCLUSIONS	Repeated training is advocated to avoid waning of the effect .

###25048073
OBJECTIVE	To study the effect of a countermovement on the lower limb force-velocity ( F-v ) mechanical profile and to experimentally test the influence of F-v mechanical profile on countermovement jump ( CMJ ) performance , independently from the effect of maximal power output ( P max ) .
METHODS	Fifty-four high-level sprinters and jumpers performed vertical maximal CMJ and squat jump ( SJ ) against five to eight additional loads ranging from 17 to 87 kg .
METHODS	Vertical ground reaction force data were recorded ( 1,000 Hz ) and used to compute center of mass vertical displacement .
METHODS	For each condition , mean force , velocity , and power output were determined over the entire push-off phase of the best trial , and used to determine individual linear F-v relationships and P max .
METHODS	From a previously validated biomechanical model , the optimal F-v profile maximizing jumping performance was determined for each subject and used to compute the individual mechanical F-v imbalance ( Fv IMB ) as the difference between actual and optimal F-v profiles .
RESULTS	A multiple regression analysis clearly showed ( r ( 2 ) = 0.952 , P < 0.001 , SEE 0.011 m ) that P max , Fv IMB and lower limb extension range ( h PO ) explained a significant part of the interindividual differences in CMJ performance ( P < 0.001 ) with positive regression coefficients for P max and h PO and a negative one for Fv IMB .
CONCLUSIONS	Compared to SJ , F-v relationships were shifted to the right in CMJ , with higher P max , maximal theoretical force and velocity ( +35.8 , 20.6 and 13.3 % , respectively ) .
CONCLUSIONS	As in SJ , CMJ performance depends on Fv IMB , independently from the effect of P max , with the existence of an individual optimal F-v profile ( Fv IMB having an even larger influence in CMJ ) .

###24502891
OBJECTIVE	To investigate whether retesting with the oral glucose tolerance test ( OGTT ) is useful and necessary for all women with polycystic ovary syndrome ( PCOS ) .
METHODS	Follow-up study .
METHODS	Tertiary medical center .
METHODS	Eighty-four women with PCOS and 45 healthy controls .
METHODS	Peripheral venous blood sampling .
METHODS	We performed a 75-g 2-hour OGTT in women with normal glucose tolerance ( NGT ) and impaired glucose tolerance ( IGT ) at the time of the first test with and without PCOS .
RESULTS	The average follow-up period for women with PCOS was 2.6 years ( range , 2-4 .17 years ) .
RESULTS	Seventy-eight of these women had NGT at baseline , 11.5 % converted to IGT , with an annualized incidence rate of 4.5 % .
RESULTS	Of those women with IGT at baseline ( n = 6 ) , 33.3 % converted to type 2 diabetes mellitus , with an annualized incidence rate of 10.4 % .
RESULTS	In the healthy subjects , the average follow-up period was 2.6 years ( range , 2-4 .08 years ) .
RESULTS	Forty-two of these women had NGT at baseline , 2.3 % converted to IGT , giving a progression of 0.9 % per year .
RESULTS	Among the three women with IGT at baseline , 33.3 % reverted to NGT , and 66.6 % had persistent IGT .
CONCLUSIONS	Conversion rates from NGT to IGT or type 2 diabetes mellitus were accelerated in women with PCOS compared with healthy subjects .
CONCLUSIONS	Women with PCOS should be tested regularly for early detection of abnormal glucose tolerance .
CONCLUSIONS	In addition , the interval for periodic rescreening should be determined by further studies involving more women with PCOS .

###24413426
OBJECTIVE	To verify the nutritive and non-nutritive stimuli efficacy in the newborn 's response to pain during venipuncture .
METHODS	The main sample was composed of 64 newborns that were randomly divided into three groups .
METHODS	The first group ( n = 20 ) received nutritive sucking stimulus that was performed through maternal breastfeeding .
METHODS	The second group ( n = 21 ) received non-nutritive sucking stimulus that was performed through the introduction of the researcher little finger in the newborn 's oral cavity .
METHODS	The third group or control group ( n = 23 ) did not receive any analgesia stimulus .
METHODS	The newborns were evaluated using the Neonatal Infant Pain Scale , and the responses to painful stimuli were compared .
RESULTS	The nutritive as well as non-nutritive suction methods provided a comforting effect , resulting in lower pain response scores ( p < 0.05 ) .
RESULTS	There was no difference between the analgesia provided by both methods ( p > 0.05 ) .
CONCLUSIONS	The nutritive and the non-nutritive sucking stimuli proved to be efficacious tools in relieving pain among newborns .

###24570029
OBJECTIVE	At northern latitudes , vitamin D is not synthesized endogenously during winter , causing low plasma 25-hydroxyvitamin D ( 25 ( OH ) D ) concentrations .
OBJECTIVE	Therefore , we evaluated the effects of a healthy Nordic diet based on Nordic nutrition recommendations ( NNR ) on plasma 25 ( OH ) D and explored its dietary predictors .
METHODS	In a Nordic multi-centre trial , subjects ( n = 213 ) with metabolic syndrome were randomized to a control or a healthy Nordic diet favouring fish ( 300g/week , including 200g/week fatty fish ) , whole-grain products , berries , fruits , vegetables , rapeseed oil and low-fat dairy products .
METHODS	Plasma 25 ( OH ) D and parathyroid hormone were analysed before and after 18 - to 24-week intervention .
RESULTS	At baseline , 45 % had vitamin D inadequacy ( < 50nmol/l ) , whereas 8 % had deficiency ( < 25nmol/l ) .
RESULTS	Dietary vitamin D intake was increased by the healthy Nordic diet ( P < 0.001 ) .
RESULTS	The healthy Nordic and the control diet reduced the prevalence of vitamin D inadequacy by 42 % ( P < 0.001 ) and 19 % ( P = 0.002 ) , respectively , without between-group difference ( P = 0.142 ) .
RESULTS	Compared with control , plasma 25 ( OH ) D ( P = 0.208 ) and parathyroid hormone ( P = 0.207 ) were not altered by the healthy Nordic diet .
RESULTS	Predictors for 25 ( OH ) D were intake of vitamin D , eicosapentaenoic acids ( EPA ) , docosahexaenoic acids ( DHA ) , vitamin D supplement , plasma EPA and plasma DHA .
RESULTS	Nevertheless , only vitamin D intake and season predicted the 25 ( OH ) D changes .
CONCLUSIONS	Consuming a healthy Nordic diet based on NNR increased vitamin D intake but not plasma 25 ( OH ) D concentration .
CONCLUSIONS	The reason why fish consumption did not improve vitamin D status might be that many fish are farmed and might contain little vitamin D or that frying fish may result in vitamin D extraction .
CONCLUSIONS	Additional ways to improve vitamin D status in Nordic countries may be needed .

###24576304
OBJECTIVE	To evaluate the effects of intravenous ( IV ) or intramuscular ( IM ) hyoscine premedication on physiologic variables following IV administration of medetomidine in horses .
METHODS	Randomized , crossover experimental study .
METHODS	Eight healthy crossbred horses weighing 330 39 kg and aged 7 4 years .
METHODS	Baseline measurements of heart rate ( HR ) , cardiac index ( CI ) , respiratory rate , systemic vascular resistance ( SVR ) , percentage of patients with second degree atrioventricular ( 2 ( o ) AV ) block , mean arterial pressure ( MAP ) , pH , and arterial partial pressures of carbon dioxide ( PaCO2 ) and oxygen ( PaO2 ) were obtained 5 minutes before administration of IV hyoscine ( 0.14 mg kg ( -1 ) ; group HIV ) , IM hyoscine ( 0.3 mg kg ( -1 ) ; group HIM ) , or an equal volume of physiologic saline IV ( group C ) .
METHODS	Five minutes later , medetomidine ( 7.5 g kg ( -1 ) ) was administered IV and measurements were recorded at various time points for 130 minutes .
RESULTS	Medetomidine induced bradycardia , 2 ( o ) AV blocks and increased SVR immediately after administration , without significant changes in CI or MAP in C. Hyoscine administration induced tachycardia and hypertension , and decreased the percentage of 2 ( o ) AV blocks induced by medetomidine .
RESULTS	Peak HR and MAP were higher in HIV than HIM at 88 18 beats minute ( -1 ) and 241 37 mmHg versus 65 16 beats minute ( -1 ) and 192 38 mmHg , respectively .
RESULTS	CI was increased significantly in HIV ( p 0.05 ) .
RESULTS	Respiratory rate decreased significantly in all groups during the recording period .
RESULTS	pH , PaCO2 and PaO2 were not significantly changed by administration of medetomidine with or without hyoscine .
CONCLUSIONS	Hyoscine administered IV or IM before medetomidine in horses resulted in tachycardia and hypertension under the conditions of this study .
CONCLUSIONS	The significance of these changes , and responses to other dose rates , requires further investigation .

###25131223
BACKGROUND	Bone damage around the joints is one of the major pathophysiological mechanisms that leads to rheumatoid arthritis ( RA ) chronic disability .
BACKGROUND	Serum tartrate-resistant acid phosphatase 5b ( TRACP-5b ) is secreted by osteoclasts , its activity can be used as a clinically relevant bone resorption marker .
BACKGROUND	The aim of this study was to test whether the measurement of serum levels of TRACP-5b in patients with RA would correlate with measures of disease activity and with responses to therapy .
METHODS	Fifty-six patients were randomly assigned to receive recombinant human cytotoxic tlymphocyte-associated antigen-4 immunoglobulin ( RhCTLA4-Ig ) , infliximab or methotrexate ( MTX ) .
METHODS	The clinical and serologic indicators of RA activity were evaluated at baseline and at 24 weeks .
METHODS	Serum TRACP-5b was measured by Enzyme-linked Immunosorbent Assay ( ELISA ) at 0 , 12 and 24 weeks .
METHODS	Hand X-rays were obtained at baseline .
RESULTS	At baseline , the levels of TRACP-5b correlated with the severity of X-ray damage , disease duration ( r = 0.332 , P = 0.012 ) , and tender joint count ( r = 0.408 , P = 0.002 ) .
RESULTS	The 24 weeks values of TRACP-5b for RhCTLA4-Ig group and infliximab group differed significantly from the baseline values in each group ( P < 0.05 ; P < 0.05 ) , whereas only the value for RhCTLA4-Ig group differed significantly from the 24 weeks value for the MTX group ( P < 0.01 ) .
RESULTS	Considering the two biologics-treated groups together , the TRACP-5b levels at 24 weeks differed significantly from the baseline values only in those patients who reached an ACR70 level ( P < 0.05 ) .
CONCLUSIONS	Measurement of serum TRACP-5b in RA patients reflects clinical and radiological measures of disease activity , treatment with certain biologics , and degree of response to therapy .
CONCLUSIONS	TRACP-5b should be investigated further as a potential biomarker to predict response to therapy , including slowing of radiographic progression .

###24370801
BACKGROUND	Different anesthetic techniques have been used for fast tracking in cardiac anesthesia .
BACKGROUND	Remifentanil , with its unique pharmacokinetic profile , could be an ideal drug for fast tracking .
BACKGROUND	Possible limitations of remifentanil are rapid onset of postoperative pain after discontinuation of the drug infusion , which may increase the risk of an ischemic event .
BACKGROUND	We conducted this randomized study to compare the efficacy of remifentanil versus low doses of fentanyl in fast-track cardiac anesthesia .
BACKGROUND	It has been hypothesized that remifentanil would provide a safe anesthesia with no impact on myocardial function and with positive effects on extubation time and mobilization .
METHODS	We compared the postoperative course of patients , the remifentanil group ( RG ) and the low-dose fentanyl group ( LDFG ) , in whom remifentanil and low-dose fentanyl , respectively , were used for fast-track cardiac anesthesia .
METHODS	The study was designed as a prospective randomized study .
METHODS	The primary outcomes were changes in the cardiac index and creatine kinase MB fraction ( CKMB ) , extubation times , mobilization times , and lengths of stay in the intensive care unit ( ICU ) and the hospital .
METHODS	Frequency of myocardial infarction ( MI ) , reoperations due to excessive bleeding , renal impairment , and cerebral complications were registered as well .
RESULTS	Seventy-one patients were enrolled in the study , and 7 were excluded due to difficult airway , bleeding , and technical difficulties .
RESULTS	The RG comprised 33 patients and the LDFG comprised of 31 patients .
RESULTS	There were no differences between the groups in terms of age , Euroscore , types of surgery , extracorporeal circulation , and aortic cross-clamp time .
RESULTS	We did not find significant difference in cardiac index , CKMB , extubation times , mobilization times , length of stay in the ICU and in the hospital between the groups .
RESULTS	Postoperative complications such as MI , rates of reoperations , renal and cerebral complications and incidence of atrial fibrillation did not show any significant differences .
CONCLUSIONS	Remifentanil fast-track anesthesia for cardiac patients has no negative impact on myocardial function .
CONCLUSIONS	Both remifentanil and low-dose fentanyl are equally effective and safe for fast-track cardiac anesthesia .
CONCLUSIONS	The study did not highlight any statistical superiority of remifentanil anesthesia over low-dose fentanyl anesthesia .

###24872377
OBJECTIVE	Rheumatoid arthritis ( RA ) patients are at an increased risk of developing comorbid conditions .
OBJECTIVE	A close monitoring of the disease targeting a status of low disease activity is associated with a better outcome .
OBJECTIVE	The aim of this trial was to evaluate the impact of a nurse-led programme on comorbidities and the impact of patient self-assessment of disease activity on the management of RA .
METHODS	We enrolled 970 patients ( mean age 58years , 79 % women ) in a prospective , randomised , controlled , open-label , 6-month trial .
METHODS	In the comorbidity group ( n = 482 ) , the nurse checked comorbidities and sent the programme results to the attending physicians .
METHODS	In the self-assessment group ( n = 488 ) , the nurse taught the patient how to calculate his/her Disease Activity Score which had to be reported on a booklet to be shared with the treating rheumatologist .
METHODS	The number of measures taken for comorbidities and the percentage of patients recording a change ( initiation , switch or increased dose ) in disease-modifying antirheumatic drugs ( DMARDs ) in the 6months follow-up period of the study defined the outcomes of the trial .
RESULTS	The number of measures taken per patient was statistically higher in the comorbidity group : 4.542.08 versus 2.651.57 ( p < 0.001 ) ; incidence rate ratio : 1.78 ( 1.61-1 .96 ) and DMARD therapy was changed more frequently in the self-assessment group : 17.2 % versus 10.9 % ( OR = 1.70 ( 1.17 ; 2.49 ) , p = 0.006 ) .
CONCLUSIONS	This study demonstrates the short-term benefit of a nurse-led programme on RA comorbidity management and the impact of patient self-assessment of disease activity on RA treatment intensification .
BACKGROUND	NCT # 01315652 .

###25464425
OBJECTIVE	The aim of the present study is to determine the long-term effects of a ten-week exercise training program in adult patients with a systemic right ventricle .
METHODS	All patients who participated in a 2009 randomized controlled trial were approached .
METHODS	At approximately three years of follow-up from initial baseline , patients underwent cardiopulmonary exercise testing , filled out two quality of life questionnaires , and NT proBNP levels were measured .
METHODS	All examinations were performed according to the protocols of the 2009 trial .
METHODS	In addition , patients were asked about their current sports habits .
RESULTS	Of the 54 patients who were randomized in the 2009-trial 40 participated in the current re-evaluation ( male 50 % , ccTGA 35 % , age 36 10 years , intervention group n = 22 , control group n = 18 ) .
RESULTS	After three years , no persistent effect of exercise training on V'Opeak training remained ( -2 % of predicted , 95 % CI -3 % to 5 % ; p = .56 ) .
RESULTS	However , patients who already participated in regular sports or exercise at baseline ( n = 23/40 ( 58 % ) ) showed higher V'Opeak of 13 % of predicted ( 95 % CI 4 % to 23 % ; p > .01 ) and a decrease of 62 % in plasma NT-proBNP ( 95 % CI -115 % to -10 % ; p > .03 ) during follow-up , when compared to patients who did not .
RESULTS	Moreover , sports were associated with a lower incidence of clinical events ( p = .032 ) .
CONCLUSIONS	Short-term beneficial effects of exercise training did not persist over a three-year follow-up period .
CONCLUSIONS	However , sports participation at baseline was associated with better exercise capacity , lower neurohormone levels , and increased event-free survival .

###25254301
OBJECTIVE	The objective of this study is to evaluate the impact of therapeutic HIV vaccination on the HIV reservoir and assess the relationship of the viral reservoir with HIV-specific immune status and viral rebound kinetics .
METHODS	A retrospective analysis of ACTG A5197 , a randomized , placebo-controlled trial of a therapeutic rAd5 HIV-1 gag vaccine .
METHODS	Participants received vaccine/placebo at weeks 0 , 4 and 26 prior to a 16-week analytic treatment interruption ( ATI ) at week 38 .
METHODS	Cell-associated HIV-1 RNA and DNA ( CA-RNA and CA-DNA ) and HIV-1 residual viremia were quantified at weeks 0 , 8 and 38 .
METHODS	HIV-specific CD4 ( + ) / CD8 ( + ) activity was assessed by an intracellular cytokine staining assay .
RESULTS	At study entry , CA-RNA and CA-DNA levels were correlated inversely with the numbers of HIV-specific CD4 ( + ) interferon - producing cells ( CA-RNA : r = -0.23 , P = 0.03 and CA-DNA : r = -0.28 , P < 0.01 , N = 93 ) .
RESULTS	Therapeutic HIV vaccination induced HIV-specific CD4 ( + ) activity , but did not significantly affect levels of CA-RNA or CA-DNA .
RESULTS	Vaccine recipients with undetectable residual viremia at week 8 had higher frequencies of HIV-specific CD4 ( + ) and CD8 ( + ) interferon - producing cells ( undetectable versus detectable residual viremia : 277 versus 161 CD4 ( + ) cells/10 ( 6 ) lymphocytes , P = 0.03 and 1326 versus 669 CD8 ( + ) cells/10 lymphocytes , P = 0.04 ) .
RESULTS	Pre-ATI CA-RNA and CA-DNA were associated with post-ATI plasma HIV set point ( CA-RNA : r = 0.51 , P < 0.01 and CA-DNA : r = 0.47 , P < 0.01 ) .
CONCLUSIONS	Vaccine-induced T-cell responses were associated with a modest transient effect on residual viremia , but more potent immune responses and/or combination treatment with latency-reversing agents are needed to reduce the HIV reservoir .
CONCLUSIONS	HIV reservoir measures may act as biomarkers of post-ATI viral rebound kinetics .
BACKGROUND	NCT00080106 .

###25142565
OBJECTIVE	To evaluate the ability of the Sonomat to diagnose obstructive sleep apnea ( OSA ) .
METHODS	Prospective and randomized .
METHODS	Sleep laboratory and home .
METHODS	62 subjects ; 54 with a clinical history of OSA and 8 normal control subjects .
METHODS	N/A .
RESULTS	Simultaneous PSG and Sonomat recordings were made in 62 subjects ; 2 were excluded due to a poor nasal flow recording in PSG .
RESULTS	There were positive correlations between the two devices for measures of sleep time , respiratory events , and the AHI ( all correlations > 0.89 ) .
RESULTS	Bland-Altman analysis of the AHI showed positive agreement between devices , particularly at levels around common diagnostic thresholds .
RESULTS	The mean difference in AHI values was 1.4 events per hour , and at a diagnostic threshold of 15 events per hour , sensitivity and specificity were 88 % and 91 % .
RESULTS	More than 93 % of PSG defined respiratory events were identified by the Sonomat and the absence of respiratory events was correctly identified in 91 % of occasions .
RESULTS	Gender , obesity , and body position did not influence the accuracy of the Sonomat .
RESULTS	PSG snore sensors differed in how much snoring was detected when compared to the Sonomat .
CONCLUSIONS	These data indicate that the Sonomat was reliable and accurate for the diagnosis of OSA .
CONCLUSIONS	The provision of audible breath sound/snoring replay permits more accurate quantification of snoring .
CONCLUSIONS	It requires no patient attachment and can be performed in the home with minimal training .

###25447585
BACKGROUND	Long-term outcomes after lung transplantation are limited due to chronic lung allograft dysfunction ( CLAD ) .
BACKGROUND	Bronchiolitis obliterans syndrome ( BOS ) is the most common form of obstructive CLAD and its definition derives from spirometric measurements .
BACKGROUND	Given the importance of this diagnosis , both the accuracy and reliability of the definition of CLAD are crucial in understanding the pathophysiology of this disease to develop therapeutic options and influence outcome after lung transplantation .
METHODS	A web-based survey was designed and distributed to members of the Pulmonary Council of the International Society for Heart and Lung Transplantation ( ISHLT ) to better understand the accuracy and reliability of pulmonary function criteria in diagnosing BOS .
METHODS	Spirometric data from five patient scenarios that were discordant among reviewers regarding BOS determination from the Assessment of Immunosuppressive Regimen in Suppressing Acute and Chronic Rejection ( AIRSAC ) trial were randomly selected and summarized in this survey .
METHODS	Survey questions included the respondent 's general understanding of the BOS definition , the determination of BOS , and difficulties with the current BOS definition .
RESULTS	Eighty-seven respondents from the Pulmonary Council of the ISHLT responded to this survey .
RESULTS	There was an overall 70 % interobserver agreement regarding the presence or absence of BOS .
RESULTS	Among those who agreed upon the presence of BOS , there was a 41 % interobserver agreement regarding its time of onset .
RESULTS	Despite this variability , the majority of respondents were not only familiar and agreed with the BOS criteria , they also felt confident in applying these criteria .
CONCLUSIONS	Our survey identified potential limitations with the current criteria for diagnosing BOS .
CONCLUSIONS	With recognition of the various CLAD phenotypes , further refinements of these diagnostic criteria will allow for an improved ability to identify and characterize patients who develop or are at risk for BOS , prognosticate outcomes , and , most importantly , marshal in future strategies directed at treating and preventing chronic lung dysfunction after lung transplantation .

###25027194
OBJECTIVE	Intravenous morphine has been used as a common method of pain control in emergency care .
OBJECTIVE	Nebulized fentanyl is also an effective temporary substitute .
OBJECTIVE	This study was designed to compare the effectiveness of nebulized fentanyl with intravenous ( IV ) morphine on management of acute limb pain .
METHODS	This was a placebo-controlled , double-blind randomized clinical trial .
METHODS	Ninety emergency department patients with moderate to severe pain aged 15 to 50 years were blocked randomized and enrolled in this study .
METHODS	Forty-seven patients in the experimental group received nebulized fentanyl ( 4 g/kg ) and IV normal saline as placebo , and the remaining 43 patients in the control group received IV morphine ( 0.1 mg/kg ) and nebulized normal saline as placebo .
METHODS	All participants ' pain scores were assessed by Numerical Rating Scale before and after intervention at 5 - , 10 - , 15 - , 30 - , 45 - , and 60-minute intervals .
METHODS	Patients ' vital sign and possible adverse effects were recorded respectively .
METHODS	Finally , all participants were assessed for their satisfaction .
RESULTS	The mean initial pain score in the experimental group was 8.7 and 8.4 in the control group ( P = .1 ) .
RESULTS	Pain relief in both groups after 5 and 10 minutes were similar ( P = .72 ) .
RESULTS	Although the pain relief was significantly greater with fentanyl at 15 minutes , this difference is not clinically significant .
RESULTS	Pain management in both groups was successful and was more than 3 scores reduction in Numerical Rating Scale .
RESULTS	Patient satisfaction in both groups was similar .
RESULTS	No adverse effects were reported in the experimental group .
CONCLUSIONS	This study suggests that nebulized fentanyl is a rapid , safe , and effective method for temporary control of acute limb pain in emergency department patients .

###24401769
BACKGROUND	This prospective double-blinded , randomized controlled trial compared adductor canal block ( ACB ) with femoral nerve block ( FNB ) in patients undergoing total knee arthroplasty .
BACKGROUND	The authors hypothesized that ACB , compared with FNB , would exhibit less quadriceps weakness and demonstrate noninferior pain score and opioid consumption at 6 to 8 h postanesthesia .
METHODS	Patients received an ACB or FNB as a component of a multimodal analgesic .
METHODS	Quadriceps strength , pain score , and opioid consumption were assessed on both legs preoperatively and at 6 to 8 , 24 , and 48 h postanesthesia administration .
METHODS	In a joint hypothesis test , noninferiority was first evaluated on the primary outcomes of strength , pain score , and opioid consumption at 6 to 8 h ; superiority on each outcome at 6 to 8 h was then assessed only if noninferiority was established .
RESULTS	Forty-six patients received ACB ; 47 patients received FNB .
RESULTS	At 6 to 8 h postanesthesia , ACB patients had significantly higher median dynamometer readings versus FNB patients ( median [ interquartile range ] , 6.1 kgf [ 3.5 , 10.9 ] ( ACB ) vs. 0 kgf [ 0.0 , 3.9 ] ( FNB ) ; P < 0.0001 ) , but was not inferior to FNB with regard to Numeric Rating Scale pain scores ( 1.0 [ 0.0 , 3.5 ] ACB vs. 0.0 [ 0.0 , 1.0 ] FNB ; P = 0.019 ) , or to opioid consumption ( 32.2 [ 22.4 , 47.5 ] ACB vs. 26.6 [ 19.6 , 49.0 ] ; P = 0.0115 ) .
RESULTS	At 24 and 48 h postanesthesia , there was no significant statistical difference in dynamometer results , pain scores , or opioid use between the two groups .
CONCLUSIONS	At 6 to 8 h postanesthesia , the ACB , compared with the FNB , exhibited early relative sparing of quadriceps strength and was not inferior in both providing analgesia or opioid intake .

###24354899
BACKGROUND	Continuous subcutaneous insulin infusion ( CSII ) treatment among children with type 1 diabetes is increasing in Sweden .
BACKGROUND	However , studies evaluating glycaemic control in children using CSII show inconsistent results .
BACKGROUND	The distribution of responsibility for diabetes self-management between children and parents is often unclear and needs clarification .
BACKGROUND	There is much published support for continued parental involvement and shared diabetes management during adolescence .
BACKGROUND	Guided Self-Determination ( GSD ) is an empowerment-based , person-centred , reflection and problem solving method intended to guide the patient to become self-sufficient and develop life skills for managing difficulties in diabetes self-management .
BACKGROUND	This method has been adapted for adolescents and parents as Guided Self-Determination-Young ( GSD-Y ) .
BACKGROUND	This study aims to evaluate the effect of an intervention with GSD-Y in groups of adolescents starting on insulin pumps and their parents on diabetes-related family conflicts , perceived health and quality of life ( QoL ) , and metabolic control .
BACKGROUND	Here , we describe the protocol and plans for study enrollment .
METHODS	This study is designed as a randomized , controlled , prospective , multicentre study .
METHODS	Eighty patients between 12-18 years of age who are planning to start CSII will be included .
METHODS	All adolescents and their parents will receive standard insulin pump training .
METHODS	The education intervention will be conducted when CSII is to be started and at four appointments in the first 4 months after starting CSII .
METHODS	The primary outcome is haemoglobin A1c levels .
METHODS	Secondary outcomes are perceived health and QoL , frequency of blood glucose self-monitoring and bolus doses , and usage of carbohydrate counting .
METHODS	The following instruments will be used : Disabkids , ` Check your health ' , the Diabetes Family Conflict Scale and the Swedish Diabetes Empowerment Scale .
METHODS	Outcomes will be evaluated within and between groups by comparing data at baseline , and at 6 and 12 months after starting treatment .
CONCLUSIONS	In this study , we will assess the effect of starting an CSII together with the model of GSD to determine whether this approach leads to retention of improved glycaemic control , QoL , responsibility distribution and reduced diabetes-related conflicts in the family .

###25572773
BACKGROUND	Nutrition in childhood has an influence on the cardiovascular function later on in life .
BACKGROUND	European Childhood Obesity Project is a multicenter , randomized clinical intervention trial examining the effect of early protein intake on later health outcomes , particularly adiposity and related disorders .
BACKGROUND	The aim of the study was to examine the effect of nutritional intervention -- different protein intake in infancy on carotid intima-media thickness ( cIMT ) at 5 years .
BACKGROUND	The association of cardiovascular risk factors with cIMT was also assessed .
METHODS	Healthy term formula-fed infants in five European countries were enrolled either to the higher ( HP ) or to the lower ( LP ) protein group .
METHODS	Observational group consisted of breastfed infants .
METHODS	Plasma insulin , glucose , lipid profile , IGF-1 , apolipoprotein A1 and B were measured as well as anthropometric parameters of parents and a child , blood pressure and physical activity .
RESULTS	No difference in cIMT between HP and LP group was observed .
RESULTS	Insulin , HOMA-IR index and total IGF-1 were positively associated with cIMT but after adjustment for confounders only an inverse association between ApoA1 and positive between ApoB/ApoA1 and cIMT were significant .
CONCLUSIONS	High versus low protein intake in infancy does not influence cIMT at 5 years .
CONCLUSIONS	cIMT in healthy children at 5 years is associated with their apolipoprotein profile .

###24842985
OBJECTIVE	Compare the efficacy and safety of monotherapy with dulaglutide , a once-weekly GLP-1 receptor agonist , to metformin-treated patients with type 2 diabetes .
OBJECTIVE	The primary objective compared dulaglutide 1.5 mg and metformin on change from baseline glycosylated hemoglobin A1c ( HbA1c ) at 26 weeks .
METHODS	This 52-week double-blind study randomized patients to subcutaneous dulaglutide 1.5 mg , dulaglutide 0.75 mg , or metformin .
METHODS	Patients ( N = 807 ) had HbA1c 6.5 % ( 48 mmol/mol ) and 9.5 % ( 80 mmol/mol ) with diet and exercise alone or low-dose oral antihyperglycemic medication ( OAM ) monotherapy ; OAMs were discontinued at beginning of lead-in period .
RESULTS	At 26 weeks , changes from baseline HbA1c ( least squares [ LS ] mean SE ) were : dulaglutide 1.5 mg , -0.78 0.06 % ( -8.5 0.70 mmol/mol ) ; dulaglutide 0.75 mg , -0.71 0.06 % ( -7.8 0.70 mmol/mol ) ; and metformin , -0.56 0.06 % ( -6.1 0.70 mmol/mol ) .
RESULTS	Dulaglutide 1.5 and 0.75 mg were superior to metformin ( LS mean difference ) : -0.22 % ( -2.4 mmol/mol ) and -0.15 % ( -1.6 mmol/mol ) ( one-sided P < 0.025 , both comparisons ) , respectively .
RESULTS	Greater percentages reached HbA1c targets < 7.0 % ( < 53 mmol/mol ) and 6.5 % ( 48 mmol/mol ) with dulaglutide 1.5 and 0.75 mg compared with metformin ( P < 0.05 , all comparisons ) .
RESULTS	No severe hypoglycemia was reported .
RESULTS	Compared with metformin , decrease in weight was similar with dulaglutide 1.5 mg and smaller with dulaglutide 0.75 mg .
RESULTS	Over 52 weeks , nausea , diarrhea , and vomiting were the most common adverse events ; incidences were similar between dulaglutide and metformin .
CONCLUSIONS	Dulaglutide improves glycemic control and is well tolerated as monotherapy in patients with early stage type 2 diabetes .

###24238737
BACKGROUND	Ischemia monitoring can not always be performed by 12-lead ECG .
BACKGROUND	Hence , the individual performance of the ECG leads is crucial .
BACKGROUND	No experimental data on the ECG 's specificity for transient ischemia exist .
METHODS	In 45 patients a 19-lead ECG was registered during a 1-minute balloon occlusion of a coronary artery ( left anterior descending artery [ LAD ] , right coronary artery [ RCA ] or left circumflex artery [ LCX ] ) .
METHODS	ST-segment shifts and sensitivity/specificity of the leads were measured .
RESULTS	During LAD occlusion , V3 showed maximal ST-segment elevation ( 0.26 mV [ IQR 0.16-0 .33 mV ] , p = 0.001 ) and sensitivity/specificity ( 88 % and 80 % ) .
RESULTS	During RCA occlusion , III showed maximal ST-elevation ( 0.2 mV [ IQR 0.09-0 .26 mV ] , p = 0.004 ) , aVF had the best sensitivity/specificity ( 85 % and 68 % ) .
RESULTS	During LCX occlusion , V6 showed maximal ST-segment elevation ( 0.04 mV [ IQR 0.02-0 .14 mV ] , p = 0.005 ) , and sensitivity/specificity was ( 31 % / 92 % ) but could be improved ( 63 % / 72 % ) using an optimized cut-off for ischemia .
CONCLUSIONS	V3 , aVF and V6 show the best performance to detect transient ischemia .

###25605812
OBJECTIVE	Subclinical depression is one of the most frequent mental comorbidities in patients with diabetes and is associated with a poorer long-term prognosis .
OBJECTIVE	Since there is a lack of specific intervention concepts for this patient group , a self-management-oriented group program ( DIAMOS [ Diabetes Motivation Strengthening ] ) was newly developed and evaluated in a randomized trial .
METHODS	DIAMOS is composed of cognitive behavioral interventions aiming at the reduction of diabetes distress .
METHODS	The active control group ( CG ) received diabetes education .
METHODS	The primary outcome was depressive symptoms .
METHODS	Secondary outcomes were diabetes distress , well-being , self-care behavior , diabetes acceptance , diabetes treatment satisfaction , HbA1c , and subclinical inflammation .
RESULTS	Two hundred fourteen participants ( mean age 43.3 13.3 years , female sex 56.5 % , type 2 diabetes 34.1 % , mean diabetes duration 14.2 10.5 years , HbA1c 8.9 1.8 % , BMI 28.7 71 kg/m ( 2 ) ) were randomized .
RESULTS	The 12-month follow-up revealed a significantly stronger reduction of depressive symptoms ( Center for Epidemiologic Studies Depression Scale score ) in the DIAMOS group compared with the CG ( 3.9 [ 95 % CI 0.6-7 .3 ] , P = 0.021 ) .
RESULTS	Of the secondary variables , the Patient Health Questionnaire-9 ( 1.7 [ 95 % CI 0.2-3 .2 ] , P = 0.023 ) , Problem Areas in Diabetes scale ( 8.2 [ 95 % CI 3.1-13 .3 ] , P = 0.002 ) , and Diabetes Distress Scale scores ( 0.3 [ 95 % CI 0.1-0 .5 ] , P = 0.012 ) displayed significant treatment effects .
RESULTS	Moreover , the risk of incident major depression in the DIAMOS group was significantly reduced ( odds ratio 0.63 [ 95 % CI 0.42-0 .96 ] , P = 0.028 ) .
RESULTS	Inflammatory variables were not substantially affected .
CONCLUSIONS	DIAMOS is more effective in lowering depressive symptoms and diabetes-related distress in diabetic patients with subclinical depression .
CONCLUSIONS	DIAMOS also has a preventive effect with respect to the incidence of major depression .

###24656963
OBJECTIVE	We compared post-breakfast closed-loop glucose control either matched with a carbohydrate-matching bolus or a weight-dependent bolus .
METHODS	Twelve adults with type 1 diabetes consumed a 75 g CHO breakfast on two occasions .
METHODS	In random order , the breakfast was accompanied by a full carbohydrate-matching insulin bolus ( 8.30 U [ 7.50 U-11 .50 U ] ) or a partial weight-dependent insulin bolus ( 0.047 U/kg ; 3.45 U [ 2.95 U-3 .75 U ] ) .
METHODS	Postprandial glucose was regulated by sensor-responsive insulin and glucagon delivery .
RESULTS	Glucose control after the weight-dependent bolus was safe and feasible ( glucose values returned to pre-prandial levels after 5 h ) .
RESULTS	However , 5-hr incremental area under the curve and percentage of time above 10 mmol/L were lower after the full bolus compared to the partial bolus ( IAUC , 2.1 [ 0.8-4 .2 ] mmol/L/hr vs 8.3 [ 6.5-11 .4 ] mmol/L/hr ; time in hyperglycaemia , 24 % [ 6 % -29 % ] vs 50 % [ 25 % -63 % ] ; P < 0.001 ) .
CONCLUSIONS	Post-breakfast closed-loop glucose control without carbohydrate counting , but based on weight-dependent bolus is feasible but a carbohydrate-matching bolus provides better glucose control .
BACKGROUND	NCT01519102 .

###24673716
OBJECTIVE	The nephrotoxicity of cyclosporine A ( CsA ) accounts for dysfunction of kidney allografts in the clinic .
OBJECTIVE	Short-term intensified dosing using enteric-coated mycophenolate sodium ( EC-MPS ) may facilitate CsA sparing after kidney transplantation without compromising safety .
METHODS	In a 12-month , single-centre open-label prospective trial , 180 de novo live-donor kidney transplant recipients at low-immunological risk were randomised to a low-dose cyclosporine group which received a low dose of cyclosporine , short-term intensified EC-MPS dosing ( 2160mg/day to week 6 , 1440mg/day thereafter ) and corticosteroids or a standard-dose cyclosporine group which received a standard dose of cyclosporine , standard EC-MPS dosing ( 1440mg/day ) and corticosteroids .
METHODS	The primary end-point [ treatment failure including biopsy-proven acute rejection ( BPAR ) , graft loss , death ] , secondary end-point and adverse events were monitored .
RESULTS	The primary end-point ( treatment failure ) occurred in 13.3 % ( 12/90 ) of the low-dose cyclosporine group and 16.7 % ( 15/90 ) of the standard-dose cyclosporine group ( p = 0.53 ) ( difference -3.4 % , 95 % confidence interval -11.7 % to 7.5 % , based on a noninferiority margin of 20 % ) .
RESULTS	BPAR occurred in 11.1 % and 13.3 % of patients in the low-dose cyclosporine group and standard-dose cyclosporine group , respectively ( p = 0.65 ) .
RESULTS	The estimated glomerular filtration rate , as calculated by the Cockcroft-Gault formula , was similar at 12months after transplantation ( low-dose cyclosporine group 6319ml/min/1 .73 m ( 2 ) and standard-dose cyclosporine group 5915ml/min/1 .73 m ( 2 ) ; p = 0.43 ) .
RESULTS	The levels of serum creatinine and occurrence of adverse events between the two groups were not statistically different .
CONCLUSIONS	A regimen of early intensified EC-MPS dosing permits low-dose cyclosporine in live-donor kidney transplant patients at low-immunological risk without compromising efficacy at 12months ' follow-up .

###24694746
OBJECTIVE	This study aimed to examine compensatory changes in nonexercise energy expenditure ( NEEx ) and nonexercise physical activity ( NEPA ) in response to an aerobic exercise training program .
METHODS	Ninety-two overweight/obese ( body mass index , 25-39 .9 kgm ) sedentary young adults ( 18-30 yr ) completed a 10-month randomized clinical efficacy trial of aerobic exercise 5 dwk at either 400 kcal per session ( n = 37 ) , 600 kcal per session ( n = 37 ) , or control ( n = 18 ) .
METHODS	Total daily energy expenditure ( TDEE ) and resting metabolic rate ( RMR ) were measured at months 0 and 10 .
METHODS	NEPA was measured by an accelerometer at months 0 , 3.5 , 7 , and 10 .
METHODS	NEEx was calculated by the following formula : [ ( total daily energy expenditure 0.9 ) - RMR ] - net EEEx ( EEEx-RMR ) .
METHODS	Mixed modeling was used to examine differences between groups ( group effect ) , within groups ( time effect ) , and group-time interaction for NEEx and NEPA .
RESULTS	Within the exercise groups , there were no significant effects ( all P > 0.05 ) of group , time , or group-time interaction for NEPA .
RESULTS	In addition , there were no significant within - or between-group differences for change in NEEx .
RESULTS	However , activity counts per minute were significantly higher ( P < 0.001 ) in the 600-kcal-per-session group ( 346 141 mind ) versus controls ( 290 106 mind ) at month 7 and significantly higher ( P < 0.001 ) in both the 600-kcal-per-session ( 345 163 mind ) and 400-kcal-per-session groups ( 317 146 mind ) versus controls ( 277 116 mind ) at 10 months .
CONCLUSIONS	A 10-month aerobic exercise training program in previously sedentary , overweight and obese young adults was not associated with compensatory decreases in NEEx or NEPA .
CONCLUSIONS	Results suggest that overweight and obese individuals do not become less physically active or spend more time in sedentary pursuits in response to exercise .

###24524204
BACKGROUND	In adult patients who are critically ill and mechanically ventilated , daily interruption of sedation ( DSI ) is an effective method of improving sedation management , resulting in a decrease of the duration of mechanical ventilation , the length of stay in the intensive care unit ( ICU ) and the length of stay in the hospital .
BACKGROUND	It is a safe and effective approach and is common practice in adult ICUs .
BACKGROUND	For critically ill children it is unknown if DSI is effective and feasible .
BACKGROUND	The aim of this multicenter randomized controlled trial is to evaluate the safety and efficacy of daily sedation interruption in critically ill children .
METHODS	Children between 0 and 18 years of age who require mechanical ventilation , with an expected duration of at least 48 h and need for sedative infusion , will be included .
METHODS	After enrollment patients will be randomly assigned to DSI in combination with protocolized sedation ( intervention group ) or protocolized continuous sedation ( control group ) .
METHODS	A sedation protocol that contains an algorithm for increasing and weaning of sedatives and analgesics will be used .
METHODS	The sedative infusion will be restarted if the patient becomes uncomfortable or agitated according to the sedation protocol .
METHODS	The primary endpoint is the number of ventilator-free days at 28 days .
BACKGROUND	NTR2030 .

###24814231
OBJECTIVE	Despite the brevity of the procedure , bilateral myringotomy and tympanostomy tube placement ( BMT ) can result in significant postoperative pain and discomfort .
OBJECTIVE	As the procedure is frequently performed without intravenous access , non-parenteral routes of administration are frequently used for analgesia .
OBJECTIVE	The current study prospectively compares the efficacy of intranasal ( IN ) dexmedetomidine with IN fentanyl for children undergoing BMT .
METHODS	This prospective , double-blinded , randomized clinical trial included pediatric patients undergoing BMT .
METHODS	The patients were randomized to receive either IN dexmedetomidine ( 1 g/kg ) or fentanyl ( 2 g/kg ) after the induction of general anesthesia with sevoflurane .
METHODS	All patients received rectal acetaminophen ( 40 mg/kg ) and the first 50 patients also received premedication with oral midazolam .
METHODS	Postoperative pain and recovery were assessed using pediatric pain and recovery scales , and any adverse effects were monitored for .
RESULTS	The study cohort included 100 patients who ranged in age from 1 to 7.7 years and in weight from 8.6 to 37.4 kg .
RESULTS	They were divided into 4 groups with 25 patients in each group : ( 1 ) midazolam premedication + IN dexmedetomidine ; ( 2 ) midazolam premedication + IN fentanyl ; ( 3 ) no premedication + IN dexmedetomidine ; and ( 4 ) no premedication + IN fentanyl .
RESULTS	Pain scores were comparable when comparing groups 2 , 3 and 4 , but were higher in group 1 ( midazolam premedication with IN dexmedetomidine ) .
RESULTS	There was no difference in total time in the post-anesthesia care unit ( PACU ) or time from arrival in the PACU until hospital discharge between the 4 groups .
RESULTS	The heart rate ( HR ) was significantly lower in group 3 when compared to the other groups at several different times after arrival to the PACU .
RESULTS	No clinically significant difference was noted in blood pressure .
CONCLUSIONS	Following BMT , when no premedication is administered , there was no clinical advantage when comparing IN dexmedetomidine ( 1 g/kg ) to IN fentanyl ( 2 g/kg ) .
CONCLUSIONS	The addition of oral midazolam as a premedication worsened the outcome measures particularly for children receiving IN dexmedetomidine .

###25092936
OBJECTIVE	The US Surgeon General has recommended that peer counseling to support breastfeeding become a core service of the Supplemental Nutrition Program for Women , Infants , and Children ( WIC ) .
OBJECTIVE	As of 2008 , 50 % of WIC clients received services from local WIC agencies that offered peer counseling .
OBJECTIVE	Little is known about the effectiveness of these peer counseling programs .
OBJECTIVE	Randomized controlled trials of peer counseling interventions among low-income women in the United States showed increases in breastfeeding initiation and duration , but it is doubtful that the level of support provided could be scaled up to service WIC participants nationally .
OBJECTIVE	We tested whether a telephone peer counseling program among WIC participants could increase breastfeeding initiation , duration , and exclusivity .
METHODS	We randomly assigned 1948 WIC clients recruited during pregnancy who intended to breastfeed or were considering breastfeeding to 3 study arms : no peer counseling , 4 telephone contacts , or 8 telephone contacts .
RESULTS	We combined 2 treatment arms because there was no difference in the distribution of peer contacts .
RESULTS	Nonexclusive breastfeeding duration was greater at 3 months postpartum for all women in the treatment group ( adjusted relative risk : 1.22 ; 95 % confidence interval [ CI ] : 1.10-1 .34 ) but greater at 6 months for Spanish-speaking clients only ( adjusted relative risk : 1.29 ; 95 % CI : 1.10-1 .51 ) .
RESULTS	The likelihood of exclusive breastfeeding cessation was less among Spanish-speaking clients ( adjusted odds ratio : 0.78 ; 95 % CI : 0.68-0 .89 ) .
CONCLUSIONS	A telephone peer counseling program achieved gains in nonexclusive breastfeeding but modest improvements in exclusive breastfeeding were limited to Spanish - speaking women .

###24345581
OBJECTIVE	How does the successful cryopreservation of semen affect the odds of post-treatment fatherhood among Hodgkin lymphoma ( HL ) survivors ?
CONCLUSIONS	Among 334 survivors who wanted to have children , the availability of cryopreserved semen doubled the odds of post-treatment fatherhood .
BACKGROUND	Cryopreservation of semen is the easiest , safest and most accessible way to safeguard fertility in male patients facing cancer treatment .
BACKGROUND	Little is known about what proportion of patients achieve successful semen cryopreservation .
BACKGROUND	To our knowledge , neither the factors which influence the occurrence of semen cryopreservation nor the rates of fatherhood after semen has been cryopreserved have been analysed before .
METHODS	This is a cohort study with nested case-control analyses of consecutive Hodgkin survivors treated between 1974 and 2004 in multi-centre randomized controlled trials .
METHODS	A written questionnaire was developed and sent to 1849 male survivors .
METHODS	Nine hundred and two survivors provided analysable answers .
METHODS	The median age at treatment was 31 years .
METHODS	The median follow-up after cryopreservation was 13 years ( range 5-36 ) .
RESULTS	Three hundred and sixty-three out of 902 men ( 40 % ) cryopreserved semen before the start of potentially gonadotoxic treatment .
RESULTS	The likelihood of semen cryopreservation was influenced by age , treatment period , disease stage , treatment modality and education level .
RESULTS	Seventy eight of 363 men ( 21 % ) used their cryopreserved semen .
RESULTS	Men treated between 1994 and 2004 had significantly lower odds of cryopreserved semen use compared with those treated earlier , whereas alkylating or second-line ( chemo ) therapy significantly increased the odds of use ; no other influencing factors were identified .
RESULTS	We found an adjusted odds ratio of 2.03 ( 95 % confidence interval 1.11-3 .73 , P = 0.02 ) for post-treatment fatherhood if semen cryopreservation was performed .
RESULTS	Forty-eight out of 258 men ( 19 % ) who had children after HL treatment became a father using cryopreserved semen .
CONCLUSIONS	Data came from questionnaires and so this study potentially suffers from response bias .
CONCLUSIONS	We could not perform an analysis with correction for duration of follow-up or provide an actuarial use rate due to lack of dates of semen utilization .
CONCLUSIONS	We do not have detailed information on either the techniques used in cryopreserved semen utilization or the number of cycles needed .
BACKGROUND	Lance Armstrong Foundation , Dutch Cancer Foundation , Ren Vogels Stichting , no competing interests .

###24500579
BACKGROUND	Our hypothesis was that patients treated with hinged external fixators as an adjunct to multiple-ligament reconstruction would have fewer reconstruction failures than patients treated without external fixation .
METHODS	In this prospective randomized study , patients with a knee dislocation either underwent ligament reconstruction with placement of an external hinged knee brace following surgery ( Group A ) or underwent ligament reconstruction with placement of a hinged external fixator ( Compass Knee Hinge ) for six weeks instead of the brace ( Group B ) .
METHODS	The patients were followed clinically and were evaluated with physical examination , Lysholm and International Knee Documentation Committee knee scores , visual analog scale pain scores , and status regarding return to work and activities .
RESULTS	One hundred patients with 103 knee dislocations were enrolled .
RESULTS	Seventy-seven patients with seventy-nine dislocations ( thirty-two in Group A and forty-seven in Group B ) , with a minimum follow-up interval of twelve months , were available for evaluation .
RESULTS	The mean duration of follow-up was thirty-nine months ( range , twelve to eighty-six months ) .
RESULTS	Nine patients ( 29 % ) in Group A had failed reconstructions compared with seven ( 15 % ) in Group B ( p = 0.15 ) .
RESULTS	Group-A patients had twenty-two ( 21 % ) of 105 reconstructed individual ligaments fail compared with eleven ( 7 % ) of 157 reconstructed ligaments in Group B.
RESULTS	The difference in ligament failure was significant ( p < 0.001 ; power > 0.8 ) , with more favorable results for the patients managed with the external fixation .
CONCLUSIONS	Hinged external fixation as a supplement to reconstruction following knee dislocation was associated with fewer failed ligament reconstructions compared with external bracing .
CONCLUSIONS	Patients presenting with highly unstable knee dislocations should be considered for hinged external fixation to supplement initial reconstructive procedures .

###24986744
OBJECTIVE	To compare dosimetric parameters , seed migration rates , operation times , and acute toxicities of intraoperatively built custom-linked ( IBCL ) seeds with those of loose seeds for prostate brachytherapy .
METHODS	Participants were 140 patients with low or intermediate prostate cancer prospectively allocated to an IBCL seed group ( n = 74 ) or a loose seed group ( n = 66 ) , using quasirandomization ( allocated by week of the month ) .
METHODS	All patients underwent prostate brachytherapy using an interactive plan technique .
METHODS	Computed tomography and plain radiography were performed the next day and 1 month after brachytherapy .
METHODS	The primary endpoint was detection of a 5 % difference in dose to 90 % of prostate volume on postimplant computed tomography 1 month after treatment .
METHODS	Seed migration was defined as a seed position > 1 cm from the cluster of other seeds on radiography .
METHODS	A seed dropped into the seminal vesicle was also defined as a migrated seed .
RESULTS	Dosimetric parameters including the primary endpoint did not differ significantly between groups , but seed migration rate was significantly lower in the IBCL seed group ( 0 % ) than in the loose seed group ( 55 % ; P < .001 ) .
RESULTS	Mean operation time was slightly but significantly longer in the IBCL seed group ( 57 min ) than in the loose seed group ( 50 min ; P < .001 ) .
RESULTS	No significant differences in acute toxicities were seen between groups ( median follow-up , 9 months ) .
CONCLUSIONS	This prospective quasirandomized control trial showed no dosimetric differences between IBCL seed and loose seed groups .
CONCLUSIONS	However , a strong trend toward decreased postimplant seed migration was shown in the IBCL seed group .

###24483776
BACKGROUND	Weight monitoring is an important element of HF self-care , yet the most clinically meaningful way to evaluate weight monitoring adherence is uncertain .
BACKGROUND	We conducted this study to evaluate the association of ( 1 ) self-reported recall and ( 2 ) daily diary-recorded weight monitoring adherence with heart failure-related ( HF-related ) hospitalization .
METHODS	We conducted a prospective cohort study among 216 patients within a randomized trial of HF self-care training .
METHODS	All patients had an initial self-care training session followed by 15 calls ( median ) to reinforce educational material ; patients were also given digital scales , instructed to weigh daily , record weights in a diary , and mail diaries back monthly .
METHODS	Weight monitoring adherence was assessed with a self-reported recall question administered at 12 months and dichotomized into at least daily versus less frequent weighing .
METHODS	Diary-recorded weight monitoring was evaluated over 12 months and dichotomized into 80 % and < 80 % adherence .
METHODS	HF-related hospitalizations were ascertained through patient report and confirmed through record review .
RESULTS	Over 12 months in 216 patients , we identified 50 HF-related hospitalizations .
RESULTS	Patients self-reporting daily or more frequent weight monitoring had an incidence rate ratio of 1.34 ( 95 % CI 0.24-7 .32 ) for HF-related hospitalizations compared to those reporting less frequent weight monitoring .
RESULTS	Patients who completed 80 % of weight diaries had an IRR of 0.37 ( 95 % CI 0.18-0 .75 ) for HF-related hospitalizations compared to patients who completed < 80 % of weight diaries .
CONCLUSIONS	Self-reported recall of weight monitoring adherence was not associated with fewer HF hospitalizations .
CONCLUSIONS	In contrast , diary-recorded adherence 80 % of days was associated with fewer HF-related hospitalizations .
CONCLUSIONS	Incorporating diary-based measures of weight monitoring adherence into HF self-care training programs may help to identify patients at risk for HF-related hospitalizations .

###25296623
BACKGROUND	Some smokers may benefit from a therapy that combines different nicotine replacement therapies ( NRT ) or drugs with different mechanisms of action.The aim of this study was to determine the efficacy of the combined therapy of varenicline and nicotine patches versus varenicline monotherapy .
METHODS	Three hundred forty-one smokers who smoked 20 or more cigarettes per day were recruited from a smoking cessation clinic between February 2012 and June 2013 .
METHODS	The participants were randomized to receive a varenicline plus nicotine patch of 21 mg every 24 hours ( 170 ) or varenicline plus a placebo patch ( 171 ) .
METHODS	All of the smokers received a standard 12-week course of varenicline and an 11-week course of either the placebo patch or the active patch after the target quit day .
METHODS	Both groups received behavioral support .
METHODS	The primary outcome was continuous abstinence for weeks 2 through 12 confirmed by exhaled levels of carbon monoxide .
METHODS	Post hoc subgroup analyses were performed to evaluate the treatment effects for a specific endpoint in subgroups of smokers .
RESULTS	The combination of the nicotine patch with varenicline was not associated with higher rates of continuous abstinence at 12 weeks ( 39.1 % versus 31.8 % ; odds ratio ( OR ) 1.24 ; 95 % confidence interval ( CI ) 0.8 to 2.6 ) and 24 weeks ( 32.8 % versus 28.2 % ; OR 1.17 ; 95 % CI 0.4 to 1.9 ) .
RESULTS	When participants were analyzed by subgroups according to cigarette consumption , the abstinence rates among smokers who smoked more than 29 cigarettes per day at 12 weeks ( OR 1.39 ; 95 % CI 1.2 to 2.5 ) and 24 weeks ( OR 1.46 ; 95 % CI 1.2 to 2.8 ) were significantly higher in the combination group .
RESULTS	Other post hoc analyses based on level of dependence and previous quit attempts did not show subgroup differences .
RESULTS	No differences between the groups for the reported adverse events were observed ( 2 value 0.07 ; P 0.79 ) .
CONCLUSIONS	The combination of varenicline with the nicotine patch does not improve abstinence rates at 12 and 24 weeks compared with varenicline used as monotherapy when all smokers were analyzed as a whole , independent of consumption level .
BACKGROUND	This study is registered at clinicaltrial.gov ( NCT01538394 ) .

###24762259
BACKGROUND	Metabolic syndrome ( MetS ) and depression have become two prevalent diseases worldwide , whose interaction needs further investigation .
BACKGROUND	Dietary treatment for weight loss in patients with MetS may improve depressive manifestations , however , the precise interactive pathways remain uncertain .
BACKGROUND	Therefore , the aim of this study was to examine the effects of a hypocaloric diet designed to reduce MetS features on self-perceived depression and the possible underlying factors .
METHODS	Sixty subjects ( Age : 50 1 y ; BMI : 36.1 0.6 kg/m ( 2 ) ) with MetS were selected from the RESMENA study ( control and intervention ) after they completed the 6-months hypocaloric treatment and rated for depressive symptoms using the Beck Depression Inventory ( BDI ) .
METHODS	Anthropometric and biochemical measurements including leptin , C-reactive protein ( CRP ) and insulin levels were evaluated .
RESULTS	Depressive symptoms decreased during the weight loss intervention , with no differences between both dietary groups ( control group -4.2 0.8 vs RESMENA group -3.2 0.6 , P = 0.490 ) .
RESULTS	The number of criteria of the MetS was higher among subjects with more somatic-related depressive symptoms at baseline ( B = 1.032 , P-trend = 0.017 ) .
RESULTS	After six months of dietary treatment , body weight decreased in all subjects ( -8.7 % ; confidence interval ( 95 % CI ) = 7.0-9 .7 ) and also self-perceived depression ( -37.9 % ; 95 % CI = 2.7-4 .9 ) , as well as circulating leptin ( -20.1 % ; 95 % CI = 1.8-6 .8 ) , CRP ( -42.8 % ; 95 % CI = 0.6-3 .0 ) and insulin ( -37.7 % ; 95 % CI = 4.1-7 .2 ) concentrations .
RESULTS	The decrease in BDI was significantly associated with declines in body fat mass ( B = 0.34 , 95 % CI = 0.11-0 .56 ) and also with the decrease in leptin ( B = 0.16 , 95 % CI = 0.04-0 .28 ) and CRP ( B = 0.24 , 95 % CI = 0.01-0 .46 ) concentrations .
CONCLUSIONS	The decrease in depressive manifestations after a weight loss intervention was related with adiposity , CRP and leptin in subjects with MetS .
BACKGROUND	ClinicalTrials.gov : NCT01087086 .

###25819484
BACKGROUND	Brain scans are essential to exclude haemorrhage in patients with suspected acute ischaemic stroke before treatment with alteplase .
BACKGROUND	However , patients with early ischaemic signs could be at increased risk of haemorrhage after alteplase treatment , and little information is available about whether pre-existing structural signs , which are common in older patients , affect response to alteplase .
BACKGROUND	We aimed to investigate the association between imaging signs on brain CT and outcomes after alteplase .
METHODS	IST-3 was a multicentre , randomised controlled trial of intravenous alteplase ( 09 mg/kg ) versus control within 6 h of acute ischaemic stroke .
METHODS	The primary outcome was independence at 6 months ( defined as an Oxford Handicap Scale [ OHS ] score of 0-2 ) .
METHODS	3035 patients were enrolled to IST-3 and underwent prerandomisation brain CT. .
METHODS	Experts who were unaware of the random allocation assessed scans for early signs of ischaemia ( tissue hypoattenuation , infarct extent , swelling , and hyperattenuated artery ) and pre-existing signs ( old infarct , leukoaraiosis , and atrophy ) .
METHODS	In this prespecified analysis , we assessed interactions between these imaging signs , symptomatic intracranial haemorrhage ( a secondary outcome in IST-3 ) and independence at 6 months , and alteplase , adjusting for age , National Institutes of Health Stroke Scale ( NIHSS ) score , and time to randomisation .
METHODS	This trial is registered at ISRCTN.com , number ISRCTN25765518 .
RESULTS	3017 patients were assessed in this analysis , of whom 1507 were allocated alteplase and 1510 were assigned control .
RESULTS	A reduction in independence was predicted by tissue hypoattenuation ( odds ratio 066 , 95 % CI 055-081 ) , large lesion ( 051 , 038-068 ) , swelling ( 059 , 046-075 ) , hyperattenuated artery ( 059 , 047-075 ) , atrophy ( 074 , 059-094 ) , and leukoaraiosis ( 072 , 059-087 ) .
RESULTS	Symptomatic intracranial haemorrhage was predicted by old infarct ( odds ratio 172 , 95 % CI 118-251 ) , tissue hypoattenuation ( 154 , 104-227 ) , and hyperattenuated artery ( 154 , 103-229 ) .
RESULTS	Some combinations of signs increased the absolute risk of symptomatic intracranial haemorrhage ( eg , both old infarct and hyperattenuated artery , excess with alteplase 138 % , 95 % CI 69-207 ; both signs absent , excess 32 % , 14-51 ) .
RESULTS	However , no imaging findings-individually or combined-modified the effect of alteplase on independence or symptomatic intracranial haemorrhage .
CONCLUSIONS	Some early ischaemic and pre-existing signs were associated with reduced independence at 6 months and increased symptomatic intracranial haemorrhage .
CONCLUSIONS	Although no interaction was noted between brain imaging signs and effects of alteplase on these outcomes , some combinations of signs increased some absolute risks .
CONCLUSIONS	Pre-existing signs should be considered , in addition to early ischaemic signs , during the assessment of patients with acute ischaemic stroke .
BACKGROUND	UK Medical Research Council , Health Foundation UK , Stroke Association UK , Chest Heart Stroke Scotland , Scottish Funding Council SINAPSE Collaboration , and multiple governmental and philanthropic national funders .

###24780180
BACKGROUND	Chronic pain impacts one-third of the U.S. population , and its effects are debilitating for individuals and costly to the medical system .
BACKGROUND	Although opioids are commonly prescribed to address chronic pain , they confer risk for misuse and addiction in some patients and may not fully restore life function-particularly with regard to psychosocial factors .
BACKGROUND	Because of the multiplicity of impacts that chronic pain may have on daily functioning , broad-spectrum behavioral interventions are needed .
OBJECTIVE	The purpose of this study was to conduct follow-up analyses from a pilot randomized controlled trial of Mindfulness-Oriented Recovery Enhancement ( MORE ) to assess specific effects of MORE on various biopsychosocial aspects of pain-related impairment .
METHODS	Chronic pain patients ( N = 115 ; mean age , 4814years ; 68 % female ) were randomly assigned to either eight weeks of MORE or a support group .
METHODS	Domains of pain-related functional interference were measured with the Brief Pain Inventory at pre - and post-treatment and at a three-month follow-up .
METHODS	Treatment effects were analyzed with multivariate intention-to-treat models .
RESULTS	MORE participants reported significantly greater reductions in functional interference than support group participants at post-treatment across all domains , including general activity , mood , walking ability , normal work , relationships , sleep , and enjoyment of life .
RESULTS	These effects were largely maintained by the three-month follow-up ; however , general activity level and walking ability were no longer significant , indicating differential long-term effects between physiological and psychological functioning .
CONCLUSIONS	Findings demonstrate preliminary efficacy of MORE as a treatment for pain-related functional impairments and suggest that effects may be more pronounced and durable for aspects of psychological function .

###24738883
OBJECTIVE	To compare efficacy , safety , and tolerability of the preservative-free fixed combination ( FC ) and non-fixed combination ( NFC ) of tafluprost 0.0015 % and timolol 0.5 % in patients with open-angle glaucoma or ocular hypertension .
METHODS	This 6-month , prospective , randomized , double-masked , active-controlled , parallel group , multicenter phase III study was performed in patients with ocular hypertension and open-angle glaucoma with untreated intraocular pressure ( IOP ) 23 and 36mmHg at baseline .
RESULTS	Four hundred patients washed out from IOP-lowering medication were randomized , 201 received the FC , and 199 received the NFC .
RESULTS	Mean time-wise IOP decreases from baseline ranged from -7.3 to -9.1 mmHg ( 29.6 % -34.6 % ) in the FC and from -7.5 to -9.4 mmHg ( 30.7 % -36.0 % ) in the NFC arm [ per-protocol ( PP ) dataset , P < 0.0001 compared with baseline for both groups ] .
RESULTS	At month 6 , the estimated overall treatment difference ( FC-NFC ) was 0.308 mmHg ( PP dataset , 95 % confidence interval from -0.194 to 0.810 mmHg ) .
RESULTS	An IOP decrease 30 % was achieved in 58.3 % and 66.9 % of the patients in the FC and NFC groups , respectively ( PP dataset ; P = 0.105 ) ; an IOP decrease 35 % was achieved in 36.6 % and 43.1 % of patients in the FC and NFC groups , respectively ( PP dataset ; P = 0.297 ) .
RESULTS	Patients with ocular adverse events were evenly distributed in both groups .
RESULTS	The most common side effect , conjunctival/ocular hyperemia was found in 8 % and 5 % of patients in the FC and NFC arms , respectively .
CONCLUSIONS	All measures of IOP reduction for FC of preservative-free tafluprost/timolol were statistically and clinically significant and non-inferior to those of the NFC , throughout the 6-month study period .

###24333069
BACKGROUND	Cross-match-compatible platelets are used for the management of thrombocytopenic patients who are refractory to transfusions of randomly selected platelets .
BACKGROUND	Data supporting the effectiveness of platelets that are compatible according to cross-matching with a modified antigen capture enzyme-linked immunosorbent assay ( MAC-ELISA or MACE ) are limited .
BACKGROUND	This study aimed to determine the effectiveness of cross-match-compatible platelets in an unselected group of refractory patients .
METHODS	One hundred ABO compatible single donor platelet transfusions given to 31 refractory patients were studied .
METHODS	Patients were defined to be refractory if their 24-hour corrected count increment ( CCI ) was < 510 ( 9 ) / L following two consecutive platelet transfusions .
METHODS	Platelets were cross-matched by MACE and the CCI was determined to monitor the effectiveness of platelet transfusions .
RESULTS	The clinical sensitivity , specificity , positive predictive value and negative predictive value of the MACE-cross-matched platelets for post-transfusion CCI were 88 % , 54.6 % , 39.3 % and 93.2 % , respectively .
RESULTS	The difference between adequate and inadequate post-transfusion 24-hour CCI for MACE cross-matched-compatible vs incompatible single donor platelet transfusions was statistically significant ( p = 0.000 ) .
RESULTS	The 24-hour CCI ( meanSD ) was significantly higher for cross-match-compatible platelets ( 9,250026.6 ) than for incompatible ones ( 6,757.942,656.5 ) ( p < 0.0001 ) .
RESULTS	Most of the incompatible cross-matches ( 73.2 % ) were due to anti-HLA antibodies , alone ( 55.3 % of cases ) or together with anti-platelet glycoprotein antibodies ( 17.9 % ) .
CONCLUSIONS	The clinical sensitivity and negative predictive value of platelet cross-matching by MACE were high in this study and such tests may , therefore , be used to select compatible platelets for refractory patients .
CONCLUSIONS	A high negative predictive value demonstrates the greater chance of an adequate response with cross-matched-compatible platelets .

###24560740
BACKGROUND	Training efforts in disaster education need to provide updated knowledge , skills and expertise to nurses through evidence-based interventions .
OBJECTIVE	The purpose of the study was the development , implementation and evaluation of an educational programme for nurses regarding the provision of health care during disasters .
METHODS	A randomized controlled trial using Switching Replications design was conducted for the evaluation of the programme .
METHODS	207 hospital-based nurses were randomly assigned into intervention ( n = 112 ) and original control ( n = 95 ) groups .
METHODS	Changes between groups and over time were measured by questionnaire and used as the outcome measure to demonstrate effectiveness of the training intervention .
RESULTS	The intervention improved nurses ' knowledge and self-confidence levels while no significant changes were detected in behavioral intentions .
RESULTS	A significant increase in the mean knowledge score was observed in both groups in times 2 and 3 compared to time 1 [ pre-test : 6.43 ( 2.8 ) ; post-test : 16.49 ( 1.7 ) ; follow-up test : 13.5 ( 2.8 ) ] , ( P < 0.002 ) .
RESULTS	Changes in knowledge between intervention and control group were significantly different ( P < 0.001 ) with a large effect size ( eta-squared = 0.8 ) .
CONCLUSIONS	The training programme was feasible and effective in improving nurses ' knowledge concerning disaster response .

###24784832
OBJECTIVE	To examine the influence of the glycemic index ( GI ) of foods consumed after evening exercise on postprandial glycemia , metabolic and inflammatory markers , and nocturnal glycemic control in type 1 diabetes .
METHODS	On two evenings ( 1700 h ) , 10 male patients ( 27 5 years of age , HbA1c 6.7 0.7 % [ 49.9 8.1 mmol/mol ] ) were administered a 25 % rapid-acting insulin dose with a carbohydrate bolus 60 min before 45 min of treadmill running .
METHODS	At 60 min postexercise , patients were administered a 50 % rapid-acting insulin dose with one of two isoenergetic meals ( 1.0 g carbohdyrate/kg body mass [ BM ] ) matched for macronutrient content but of either low GI ( LGI ) or high GI ( HGI ) .
METHODS	At 180 min postmeal , the LGI group ingested an LGI snack and the HGI group an HGI snack ( 0.4 g carbohdyrate/kg BM ) before returning home ( 2300 h ) .
METHODS	Interval samples were analyzed for blood glucose and lactate ; plasma glucagon , epinephrine , interleukin-6 ( IL-6 ) , and tumor necrosis factor - ( TNF - ) ; and serum insulin , cortisol , nonesterified fatty acid , and - hydroxybutyrate concentrations .
METHODS	Interstitial glucose was recorded for 20 h postlaboratory attendance through continuous glucose monitoring .
RESULTS	Following the postexercise meal , an HGI snack induced hyperglycemia in all patients ( mean SD glucose 13.5 3.3 mmol/L ) and marked increases in TNF - and IL-6 , whereas relative euglycemia was maintained with an LGI snack ( 7.7 2.5 mmol/L , P < 0.001 ) without inflammatory cytokine elevation .
RESULTS	Both meal types protected all patients from early hypoglycemia .
RESULTS	Overnight glycemia was comparable , with a similar incidence of nocturnal hypoglycemia ( n = 5 for both HGI and LGI ) .
CONCLUSIONS	Consuming LGI food with a reduced rapid-acting insulin dose following evening exercise prevents postprandial hyperglycemia and inflammation and provides hypoglycemia protection for 8 h postexercise ; however , the risk of late nocturnal hypoglycemia remains .

###25624389
OBJECTIVE	The study goal was to determine whether clonidine treatment of neonatal abstinence syndrome ( NAS ) would result in a better neurobehavioral performance compared with morphine .
METHODS	This pilot study prospectively enrolled infants 35 weeks ' gestational age admitted for treatment of NAS .
METHODS	After informed consent was obtained , infants were randomized to receive morphine ( 0.4 mg/kg per day ) or clonidine ( 5 g/kg per day ) divided into 8 doses .
METHODS	A 25 % dose escalation every 24 hours was possible per protocol ( maximum of 1 mg/kg per day for morphine and 12 g/kg per day for clonidine ) .
METHODS	After control of symptoms , the dose was tapered by 10 % every other day .
METHODS	Clinical staff monitored infants by using Finnegan scoring .
METHODS	Masked research staff administered the NICU Network Neurobehavioral Scale ( NNNS ) at 1 week and at 2 to 4 weeks after initiation of treatment and the Bayley Scales III , and Preschool Language Scale IV , at 1-year adjusted age .
METHODS	Analyses included descriptive statistics , repeated measures analysis of variance , and Wilcoxon tests .
RESULTS	Infants treated with morphine ( n = 15 ) versus clonidine ( n = 16 ) did not differ in birth weight or age at treatment .
RESULTS	Treatment duration was significantly longer for morphine ( median 39 days ) than for clonidine ( median 28 days ; P = .02 ) .
RESULTS	NNNS summary scores improved significantly with clonidine but not with morphine .
RESULTS	On subsequent assessment , those receiving clonidine had lower height of arousal and excitability ( P < .05 ) .
RESULTS	One-year motor , cognitive , and language scores did not differ between groups .
CONCLUSIONS	Clonidine may be a favorable alternative to morphine as a single-drug therapy for NAS .
CONCLUSIONS	A multicenter randomized trial is warranted .

###24308894
OBJECTIVE	The study examined the rate of remission in individuals experiencing a first episode of schizophrenia ( FES ) in China and explored predictors of remission in the acute phase of the illness .
METHODS	Fifty-five FES patients were randomly treated with risperidone , olanzapine , or aripiprazole at therapeutic doses for 8 weeks , and their clinical profiles and cognition were assessed using standardized assessment instruments at entry and the end of the study .
RESULTS	Of the 55 patients , 30 ( 54.5 % ) remitted by the end of the 8-week study .
RESULTS	In univariate analyses , shorter duration of untreated psychosis , higher scores on both the time-based prospective memory ( TBPM ) and event-based prospective memory tasks and the Hopkins Verbal Learning Test-revised , and less severe negative symptoms were significantly associated with remission .
RESULTS	In stepwise multiple logistic regression analyses , only higher scores on the TBPM significantly predicted remission .
RESULTS	Individuals having higher scores reflecting better TBPM at baseline were more likely to achieve remission after 8 weeks of optimized antipsychotic treatment .
CONCLUSIONS	TPBM may be useful in helping clinicians identify those FES patients most likely to achieve a favorable treatment response .

###24517252
OBJECTIVE	Danoprevir is a hepatitis C virus ( HCV ) protease inhibitor with activity against genotypes ( G ) 1/G4 , which is maintained at lower doses by ritonavir-boosting .
OBJECTIVE	We report results of a large , randomized , active-controlled phase IIb study of ritonavir-boosted danoprevir ( danoprevir/r ) plus peginterferon alpha-2a / ribavirin ( P/R ) in treatment-naive patients with HCV G1/4 infection .
METHODS	Treatment-naive patients with HCV G1/4 infection were randomized to twice-daily danoprevir/r 200/100 mg ( A , n = 92 ) ; 100/100 mg ( B , n = 93 ) ; or 50/100 mg ( C , n = 94 ) plus P/R for 24 weeks ; twice-daily danoprevir/r 100/100 mg ( D , n = 94 ) plus P/R for 12 or 24 weeks ; or P/R alone ( E , n = 44 ) for 48 weeks .
METHODS	Patients in the response-guided therapy arm ( D ) with an extended rapid virological response ( eRVR2 : HCV RNA < 15 IU/ml during Weeks 2-10 ) stopped all therapy at Week 12 ; non-eRVR2 patients continued all treatment to Week 24 .
METHODS	The primary efficacy endpoint was sustained the virological response ( SVR24 : HCV RNA < 15 IU/ml after 24 weeks of untreated follow-up ) .
RESULTS	SVR24 rates in Arms A , B , C , D and E were 89.1 % , 78.5 % , 66.0 % , 69.1 % and 36.4 % , respectively , in the overall population ; 83.6 % , 69.6 % , 60.3 % , 59.2 % and 38.5 % in G1a-infected patients , 96.6 % , 93.1 % , 73.1 % , 78.4 % and 28.6 % in G1b-infected patients and 100 % , 87.5 % , 100 % , 100 % and 66.7 % in G4-infected patients .
RESULTS	Danoprevir/r plus P/R was generally well tolerated compared with P/R alone .
RESULTS	There was a higher incidence of serious adverse events in danoprevir-treatment arms , but most were associated with P/R .
CONCLUSIONS	The combination of danoprevir/r plus P/R is efficacious in treatment-nave patients with HCV genotype 1 or 4 infection .

###25363176
BACKGROUND	There is debate on renal graft stenting during ureteroneocystostomy , patients with ureteral stents may encounter several complications such as encrustation , stent crustation which can lead to loss of kidney , and complications related to stent extraction : pain and UTI increasing related to cystoscopy for stent extraction accompanying excess expenses .
BACKGROUND	This study designed to reduce complications related to stent extraction .
METHODS	90 patients prepared for renal transplantation during 1 year randomly classified to groups , study group : patients with attached stent to Foley catheter , control group : patients with conventional technique ( stent separated from Foley ) then in their follow up ; UTI , stent crustation , luts severity compared to each other .
RESULTS	Second week and fourth week UTI reported 25.6 % , 2.3 % in study group versus 34.9 % , 4.7 % in control group ( P.value :0.48 and 0.5 ) .
RESULTS	Urinary leakage was 3.3 % overall , that all of them occurred in separate stent group , 37.5 % vs. 0 % in the linked stent group .
RESULTS	Stent crustation in separate stent was 25 % compared with 0 % in the linked stent .
CONCLUSIONS	Low complications rate in linked stent group , despite the lack of significant statistical differences , but indicate the effectiveness and success of the new technique .

###25619206
BACKGROUND	Wound edge eversion has been hypothesized to improve aesthetic outcomes after cutaneous wound closure .
BACKGROUND	Data supporting this assertion are sparse .
OBJECTIVE	We sought to determine if wound eversion , achieved with interrupted subcuticular sutures , improves aesthetic outcome compared with planar closures .
METHODS	We undertook a prospective , randomized , split-scar intervention in patients who underwent cutaneous surgery .
METHODS	Half of the wound was randomized to an everted or planar repair ; the other side received the opposite one .
METHODS	At 3 - and 6-month follow-up , both the patient and 2 blinded observers evaluated the wound using the Patient Observer Self-Assessment Scale ( POSAS ) .
RESULTS	The total observer POSAS score for the everted ( 13.59 , 12.26 ) and planar ( 12.91 , 12.98 ) sides did not differ significantly at 3 or 6 months , respectively .
RESULTS	Similarly , there was not a significant difference in patient assessment between the everted ( 16.23 , 12.84 ) and planar ( 15.07 , 12.79 ) sides at 3 or 6 months , respectively .
RESULTS	Finally , there was no significant difference between the 2 closure methods in terms of scar height or width at follow-up .
CONCLUSIONS	This was a single-center trial , which used a validated but still subjective scar assessment instrument .
CONCLUSIONS	Wound eversion was not significantly associated with improved overall scar assessments byblinded observers or patient assessment .

###24444704
BACKGROUND	Anal incontinence is a frequent complaint that profoundly affects quality of life .
BACKGROUND	Our aim was to determine whether perineal retraining gives additional benefits to standard medical treatment .
METHODS	Patients with anal incontinence and a Wexner score > 4 were randomly assigned to standard conservative treatment ( control ) or perineal retraining , including biofeedback , in addition to standard treatments ( biofeedback ) .
METHODS	Diaries , self-administered questionnaires and satisfaction scores quantified the benefits .
METHODS	Self-evaluated improvement was the primary outcome measure .
METHODS	A score 3 ( in an improvement scale from -5 to +5 ) defined success .
RESULTS	Overall , 157 patients were included ; 80 in the control group ( 75 % females , mean age 60.1 13.2 years ) and 77 in the biofeedback group ( 79 % females , mean age 61.9 10.2 years ) .
RESULTS	After a 4-month follow-up , the success rate was significantly higher in the biofeedback group ( 57 % versus 37 % ; p < 0.021 ) .
RESULTS	In the biofeedback group , daily stool frequency , leakage , and faecal urgency significantly decreased , and daily non-urgent perception of stool increased .
RESULTS	Conversely , symptomatic scores and quality of life scales did not significantly differ between groups .
RESULTS	In a multivariate model , the adjusted odds ratio showed that perineal retraining was significantly associated with a higher chance of self-rated improvement ( adjusted Odd Ratio [ 95 % CI ] : 2.34 [ 1.14-4 .80 ] ; p = 0.021 ) .
CONCLUSIONS	Perineal retraining offers a moderate but significant benefit for patients suffering from anal incontinence .

###25533338
BACKGROUND	Workplace stress in Australia and other western countries has been steadily increasing over the past decade .
BACKGROUND	It can be observed not only in terms of increased compensation claims but also costs due to absenteeism , loss of productivity at work and reduced psychological and physiological health and well-being .
BACKGROUND	Given the cost and pervasive effects of stress in the modern workforce , time efficient and cost-effective interventions capable of reducing occupational stress ( or strain ) and burnout are urgently required for the improved well-being of stressed employees .
BACKGROUND	One intervention gaining scientific traction is supplementation with nutritional interventions , particularly the B group vitamins .
METHODS	This study was developed to examine the effects of B group vitamins on workplace stress and mood variables with a sample of full-time employed older adults who subjectively report feeling stressed .
METHODS	The study is a randomized , double-blind , placebo-controlled , parallel-groups clinical trial where 200 ( N = 100/group ) participants will be randomized to receive Blackmores Executive B Stress Formula or placebo daily for a period of 6months .
METHODS	Participants will be tested at baseline and 6months post-randomization on workplace stress , cognitive , personality and mood measures , cardiovascular ( brachial and aortic systolic and diastolic blood pressures as well as arterial stiffness ) , biochemical ( assays to measure inflammation and safety ) as well as genetic assessments ( to assess stress processing ) and neuroimaging measures ( to investigate in vivo mechanisms of action of B vitamins ) .
METHODS	In addition to this pre - and post - supplementation testing , participants will also complete a battery of self-report questionnaires online to assess their stress and mood once a month for the duration of the study .
METHODS	The primary aim of the study is to investigate the effects of B vitamin supplementation on work related stress .
METHODS	The secondary aims are to explore the mechanisms underpinning any changes in mood or workplace stress due to the B vitamin intervention by examining relationships between cognitive , biological , neuroimaging and cardiovascular variables over 6months .
METHODS	A subset of 40 participants ( N = 20/group ) will undergo neuroimaging at baseline and at 6months using functional magnetic resonance imaging ( fMRI ) and magnetic resonance spectroscopy ( MRS ) in order to further explore in vivo mechanisms of action of B vitamins .
BACKGROUND	Australia and New Zealand Clinical Trials Register ( ANZCTR ) : ACTRN12613000294752 .

###25875679
OBJECTIVE	The purpose of this work was to evaluate the potential of a novel custom-designed rigid gas permeable ( RGP ) contact lens to modify the relative peripheral refractive error in a sample of myopic patients .
METHODS	Fifty-two right eyes of 52 myopic patients ( mean [ SD ] age , 21 [ 2 ] years ) with spherical refractive errors ranging from -0.75 to -8.00 diopters ( D ) and refractive astigmatism of 1.00 D or less were fitted with a novel experimental RGP ( ExpRGP ) lens designed to create myopic defocus in the peripheral retina .
METHODS	A standard RGP ( StdRGP ) lens was used as a control in the same eye .
METHODS	The relative peripheral refractive error was measured without the lens and with each of two lenses ( StdRGP and ExpRGP ) using an open-field autorefractometer from 30 degrees nasal to 30 degrees temporal , in 5-degree steps .
METHODS	The effectiveness of the lens design was evaluated as the amount of relative peripheral refractive error difference induced by the ExpRGP compared with no lens and with StdRGP conditions at 30 degrees in the nasal and temporal ( averaged ) peripheral visual fields .
RESULTS	Experimental RGP lens induced a significant change in relative peripheral refractive error compared with the no-lens condition ( baseline ) , beyond the 10 degrees of eccentricity to the nasal and temporal side of the visual field ( p < 0.05 ) .
RESULTS	The maximum effect was achieved at 30 degrees .
RESULTS	Wearing the ExpRGP lens , 60 % of the eyes had peripheral myopia exceeding -1.00 D , whereas none of the eyes presented with this feature at baseline .
RESULTS	There was no significant correlation ( r = 0.04 ; p = 0.756 ) between the degree of myopia induced at 30 degrees of eccentricity of the visual field with the ExpRGP lens and the baseline refractive error .
CONCLUSIONS	Custom-designed RGP contact lenses can generate a significant degree of relative peripheral myopia in myopic patients regardless of their baseline spherical equivalent refractive error .

###25500422
BACKGROUND	Since the introduction of breast-conserving treatment , various radiation doses after lumpectomy have been used .
BACKGROUND	In a phase 3 randomised controlled trial , we investigated the effect of a radiation boost of 16 Gy on overall survival , local control , and fibrosis for patients with stage I and II breast cancer who underwent breast-conserving treatment compared with patients who received no boost .
BACKGROUND	Here , we present the 20-year follow-up results .
METHODS	Patients with microscopically complete excision for invasive disease followed by whole-breast irradiation of 50 Gy in 5 weeks were centrally randomised ( 1:1 ) with a minimisation algorithm to receive 16 Gy boost or no boost , with minimisation for age , menopausal status , presence of extensive ductal carcinoma in situ , clinical tumour size , nodal status , and institution .
METHODS	Neither patients nor investigators were masked to treatment allocation .
METHODS	The primary endpoint was overall survival in the intention-to-treat population .
METHODS	The trial is registered with ClinicalTrials.gov , number NCT02295033 .
RESULTS	Between May 24 , 1989 , and June 25 , 1996 , 2657 patients were randomly assigned to receive no radiation boost and 2661 patients randomly assigned to receive a radiation boost .
RESULTS	Median follow-up was 17.2 years ( IQR 13.0-19 .0 ) .
RESULTS	20-year overall survival was 59.7 % ( 99 % CI 56.3-63 .0 ) in the boost group versus 61.1 % ( 57.6-64 .3 ) in the no boost group , hazard ratio ( HR ) 1.05 ( 99 % CI 0.92-1 .19 , p = 0.323 ) .
RESULTS	Ipsilateral breast tumour recurrence was the first treatment failure for 354 patients ( 13 % ) in the no boost group versus 237 patients ( 9 % ) in the boost group , HR 0.65 ( 99 % CI 0.52-0 .81 , p < 0.0001 ) .
RESULTS	The 20-year cumulative incidence of ipsilatelal breast tumour recurrence was 16.4 % ( 99 % CI 14.1-18 .8 ) in the no boost group versus 12.0 % ( 9.8-14 .4 ) in the boost group .
RESULTS	Mastectomies as first salvage treatment for ipsilateral breast tumour recurrence occurred in 279 ( 79 % ) of 354 patients in the no boost group versus 178 ( 75 % ) of 237 in the boost group .
RESULTS	The cumulative incidence of severe fibrosis at 20 years was 1.8 % ( 99 % CI 1.1-2 .5 ) in the no boost group versus 5.2 % ( 99 % CI 3.9-6 .4 ) in the boost group ( p < 0.0001 ) .
CONCLUSIONS	A radiation boost after whole-breast irradiation has no effect on long-term overall survival , but can improve local control , with the largest absolute benefit in young patients , although it increases the risk of moderate to severe fibrosis .
CONCLUSIONS	The extra radiation dose can be avoided in most patients older than age 60 years .
BACKGROUND	Fonds Cancer , Belgium .

###24957661
OBJECTIVE	To record the fate of transfused platelet doses in the North of England , and thereby assist with demand-planning and help target teaching on appropriate use .
BACKGROUND	Platelet use has risen recently to the extent that donation practice has changed to meet demand .
BACKGROUND	Two national comparative audits have shown inappropriate use and the 2010 audit concluded that current U.K. guidelines for platelet usage should be completely implemented at a local level .
BACKGROUND	It is necessary to know how platelets are used and by whom in order to facilitate guideline concordance .
METHODS	All hospital trusts in the North East and Cumbria recorded data on all platelet doses transfused in two separate 4-week periods in 2012 .
METHODS	Data were entered onto an electronic survey tool .
RESULTS	One thousand and five hundred and seventy-four reports were received , documenting 1937 transfused doses -- 96 % of total issues for the study periods .
RESULTS	One thousand and forty-five platelet doses ( 54 % ) were given for haematological indications .
RESULTS	The second commonest indication was cardiac surgery ( 201 doses , 10 % of the total ) followed by non-haematological oncology ( 127 doses , 6.5 % ) , critical care ( 106 doses , 5 % ) and liver disease ( 50 doses , 2.5 % ) .
RESULTS	The commonest haematological indication was acute myeloid leukaemia , 310 doses , ( 16 % of all platelet use ) , followed by stem cell transplantation , 271 doses ( 14 % ) .
RESULTS	Seventy-two percent of platelet doses were given prophylactically , the majority without any planned procedure .
CONCLUSIONS	The commonest indication for platelet use , where reinforcement of guidelines will be productive , is prophylaxis in haematological disease .
CONCLUSIONS	Use of platelets in cardiac surgery is also worthy of close scrutiny .

###24332551
BACKGROUND	The aim of this study was to evaluate the safety and efficacy of thyroidectomy using the Harmonic ACE scalpel ( HS ) or the LigaSure Precise ( LS ) instrument in conventional thyroidectomy .
METHODS	A prospective , randomized controlled trial was performed .
METHODS	Between August 2011 and June 2012 , 832 patients who required thyroidectomy for papillary thyroid cancer were randomized into groups treated with either the HS or the LS instrument .
METHODS	Operative time and surgical morbidities were analyzed .
RESULTS	A total of 320 patients ( HS group , N = 164 ; LS instrument group , N = 156 ) were randomized for analysis according to the intention-to-treat principle .
RESULTS	There were no statistically significant differences in the operative times ( HS group versus LS instrument group : 71.9318.26 versus 75.1520.13 ; P = 0.423 ) , postoperative transient hypoparathyroidism ( 13.4 % versus 14.1 % ; P = 0.858 ) , and permanent recurrent laryngeal nerve injuries between the two groups .
CONCLUSIONS	In this study , both hemostatic devices were safe and effective in terms of postoperative results and complications without any differences .

###25765698
BACKGROUND	Mortality in people in Africa with HIV infection starting antiretroviral therapy ( ART ) is high , particularly in those with advanced disease .
BACKGROUND	We assessed the effect of a short period of community support to supplement clinic-based services combined with serum cryptococcal antigen screening .
METHODS	We did an open-label , randomised controlled trial in six urban clinics in Dar es Salaam , Tanzania , and Lusaka , Zambia .
METHODS	From February , 2012 , we enrolled eligible individuals with HIV infection ( age 18 years , CD4 count of < 200 cells per L , ART naive ) and randomly assigned them to either the standard clinic-based care supplemented with community support or standard clinic-based care alone , stratified by country and clinic , in permuted block sizes of ten .
METHODS	Clinic plus community support consisted of screening for serum cryptococcal antigen combined with antifungal therapy for patients testing antigen positive , weekly home visits for the first 4 weeks on ART by lay workers to provide support , and in Tanzania alone , re-screening for tuberculosis at 6-8 weeks after ART initiation .
METHODS	The primary endpoint was all-cause mortality at 12 months , analysed by intention to treat .
METHODS	This trial is registered with the International Standard Randomised Controlled Trial Number registry , number ISCRTN 20410413 .
RESULTS	Between Feb 9 , 2012 , and Sept 30 , 2013 , 1001 patients were randomly assigned to clinic plus community support and 998 to standard care .
RESULTS	89 ( 9 % ) of 1001 participants in the clinic plus community support group did not receive their assigned intervention , and 11 ( 1 % ) of 998 participants in the standard care group received a home visit or a cryptococcal antigen screen rather than only standard care .
RESULTS	At 12 months , 25 ( 2 % ) of 1001 participants in the clinic plus community support group and 24 ( 2 % ) of 998 participants in the standard care group had been lost to follow-up , and were censored at their last visit for the primary analysis .
RESULTS	At 12 months , 134 ( 13 % ) of 1001 participants in the clinic plus community support group had died compared with 180 ( 18 % ) of 998 in the standard care group .
RESULTS	Mortality was 28 % ( 95 % CI 10-43 ) lower in the clinic plus community support group than in standard care group ( p = 0004 ) .
CONCLUSIONS	Screening and pre-emptive treatment for cryptococcal infection combined with a short initial period of adherence support after initiation of ART could substantially reduce mortality in HIV programmes in Africa .
BACKGROUND	European and Developing Countries Clinical Trials Partnership .

###25241302
OBJECTIVE	To compare standard coil embolization versus the use of an antireflux microcatheter ( ARM ) in patients undergoing planning angiography before selective internal radiation therapy ( SIRT ) .
METHODS	A prospective , single-center trial was performed in which 30 patients were randomly assigned to undergo SIRT with coil embolization or the use of an ARM .
METHODS	The coil group underwent detachable coil embolization of nontarget vessels , and the ARM group underwent infusion of macroaggregated albumin with use of an ARM system , without coil embolization .
METHODS	Single-photon emission computed tomography ( CT ) / CT was then performed to assess for nontarget distribution .
METHODS	The primary endpoint was fluoroscopy time during planning angiography .
METHODS	Secondary endpoints included deployment time , total procedure time , radiation dose-area product , contrast agent used , and adverse events .
METHODS	Endpoints were evaluated during planning angiography and SIRT .
RESULTS	Over a 9-month period , 30 consecutive patients were randomized at a 1:1 ratio between coil embolization and ARM groups .
RESULTS	Technical success rates were 100 % in both groups .
RESULTS	Mean fluoroscopy time was significantly reduced in the ARM group versus the coil embolization group ( 1.8 min [ range , 0.4-4 .9 min ] vs 6.0 min [ range , 1.9-15 .7 min ] ; P = .002 ) .
RESULTS	The planning procedure time ( P < .001 ) , deployment time ( P < .001 ) , dose-area product ( P = .04 ) , and amount of contrast agent used ( P < .001 ) were also significantly less in the ARM group than in the coil embolization group .
RESULTS	No nontarget distribution was detected in either group .
RESULTS	There was no difference between groups in dose delivered on the day of SIRT ( P = .71 ) .
RESULTS	There were no major or minor adverse events at 30 days .
CONCLUSIONS	The use of an ARM during planning angiography can significantly reduce fluoroscopy time , procedure time , and radiation dose .

###24290749
OBJECTIVE	Diffuse isolated liver metastases are the dominant mode of tumor progression in a number of cancers and present a major treatment challenge for oncologists .
OBJECTIVE	An experimental treatment , percutaneous hepatic perfusion ( PHP ) , utilizes partial venovenous cardiopulmonary bypass to allow administration of high-dose chemotherapy directly and solely to the liver with filtration of chemotherapeutic agents from the blood prior to its return to the systemic circulation , thereby minimizing toxic systemic effects .
OBJECTIVE	The following case series describes the management of 5 patients with metastatic melanoma undergoing serial PHPs .
METHODS	A single-center experience from a national multi-center random-assignment trial comparing PHP to best alternative care ( BAC ) in patients with diffuse melanoma liver metastases .
METHODS	A tertiary care hospital .
METHODS	Five patients with metastatic melanoma to the liver .
METHODS	Five patients underwent a total of fifteen PHPs using a venovenous bypass circuit with hemofiltration , receiving hepatic intra-arterial melphalan , 3 mg/kg of ideal body weight , for 30 minutes with a total of 60 minutes of hemofiltration .
RESULTS	Five patients tolerated the procedure well with transient hemodynamic and metabolic changes .
CONCLUSIONS	In patients with diffuse isolated liver metastases , PHP is a safe and well-tolerated procedure that can be performed more than once and is associated with marked anti-tumor activity in some patients .

###24647296
BACKGROUND	Neonatal circumcision is one of the oldest and most frequently performed surgical procedures on males .
BACKGROUND	Newborns demonstrate strong endogenous reaction to pain and therefore modalities are being explored for optimum pain relief during circumcision .
BACKGROUND	Pediatric nurses have a vital role for the use of these modalities and minimising the pain response during the neonatal minor procedures .
OBJECTIVE	The aim of this study was to assess the effectiveness of eutectic mixture of local anaesthetic ( EMLA ) cream compared with oral sucrose and both in alleviating pain in neonatal circumcision .
METHODS	This study was conducted in the Day Care Surgery Department of Maternity and Children Hospital , Dammam City , KSA .
METHODS	90 full-term newborn males who underwent circumcision were divided randomly into three groups ( 30 each ) .
METHODS	Each group was assigned to receive a different type of analgesics such as EMLA cream ( Group A ) , oral sucrose ( Group B ) or combination of EMLA cream and oral sucrose ( Group C ) .
METHODS	Neonatal pain agitation and sedation scale ( N-PASS ) was used 5 min before , during and 5 min after the circumcision procedure to assess the neonatal response to pain .
RESULTS	N-PASS scores were significantly lower in Group C ( median Group C = 5.2 , Group A = 5.8 , Group B = 8.5 ; P < 0.001 ) .
RESULTS	The endogenous response to pain in terms of escalation of heart rate and reduction in O 2 saturation were minimal among Group C ( P < 0.0001 ) .
RESULTS	Duration of crying was comparable among all the groups .
CONCLUSIONS	The combination of sucrose and EMLA cream revealed a higher analgesic effect and minimal adverse response to pain than either EMLA cream or sucrose alone during neonatal circumcision .

###24573731
OBJECTIVE	Colonoscopy is one of the most reliable methods for the detection of colorectal neoplasms .
OBJECTIVE	However , colonic peristalsis during colonoscopy results in some neoplastic lesions being hidden from view and commonly requires an intravenous or intramuscular injection of antispasmodic agents , which may sometimes causes unexpected adverse reactions .
OBJECTIVE	The aim of this study was to evaluate the efficacy of L-menthol spray as an antiperistaltic agent and its effect on adenoma detection .
METHODS	This was a prospective , randomized , single-blind placebo-controlled trial .
METHODS	A total of 226 patients who were scheduled to undergo colonoscopy were randomly assigned to receive either 20mL of 1.6 % L-menthol ( n = 118 ) or placebo ( n = 108 ) .
METHODS	Both treatments were sprayed locally onto the colonic mucosa via an endoscope .
METHODS	The adenoma detection rate ( ADR ) and the proportion of patients with no peristalsis were the primary and secondary outcomes , respectively .
RESULTS	The ADR was significantly higher in the L-menthol group than in the placebo group ( 60.2 % vs. 42.6 % ; P = 0.0083 ) .
RESULTS	The proportion of patients with no peristalsis after treatment with L-menthol was significantly higher than in the placebo group ( 71.2 % vs. 30.9 % ; P < 0.0001 ) .
RESULTS	There were no adverse effects in either group .
CONCLUSIONS	The results suggest that the suppression of colonic peristalsis by L-menthol sprayed directly onto the colonic mucosa improves the ADR .
BACKGROUND	ID : UMIN 000007972 .

###24791618
OBJECTIVE	Limited information is available regarding sedation and motor function following repeat dosing of antihistamines .
OBJECTIVE	This study examined how promethazine and loratadine affect day-time drowsiness , the commencement of voluntary movement , and involuntary movement when administered on consecutive days .
METHODS	Ten healthy young subjects ( 245years ) were recruited into a double-blind , placebo-controlled , three-way crossover study .
METHODS	Subjects ingested either promethazine , loratadine or a placebo , and ingested the same drug 24h later .
METHODS	Measures of drowsiness , simple reaction time ( SRT ) , choice reaction time ( CRT ) , and postural tremor were obtained pre-ingestion , 1h post-ingestion and 2h post-ingestion on each day .
RESULTS	Consecutive daily doses of promethazine and loratadine affected SRT and CRT , respectively , whereby reaction time deficits were less pronounced following the repeat dose .
RESULTS	A reduced tremor response was also observed following consecutive daily dosing of promethazine , in contrast to loratadine which caused an increase in tremor amplitude with the consecutive daily dose .
CONCLUSIONS	Reaction time and tremor responses differed following the single dose compared to consecutive doses .
CONCLUSIONS	Sufferers of allergic rhinitis often require antihistamine dosing regimens that continue over multiple days .
CONCLUSIONS	Future studies will benefit from examining drowsiness and movement responses following single doses as well as consecutive dosing .

###24851847
BACKGROUND	Stress-relieving effects of balneotherapy compared to progressive muscle relaxation ( PMR ) and to resting were investigated by measuring subjective relaxation and salivary cortisol .
BACKGROUND	It was also examined whether participants with a high versus low stress level would have a different relaxation response .
METHODS	A sample of healthy volunteers was randomized to balneotherapy , PMR , or a resting control group , each intervention lasting for 25 min .
METHODS	Pre - and post-intervention salivary cortisol samples were collected , and participants rated their status of relaxation on a quantitative scale .
METHODS	In addition , 3 questionnaires were applied to detect participants ' stress level and bodily complaints .
RESULTS	49 healthy participants were recruited ( 65.3 % female ) .
RESULTS	In a pre-post comparison , salivary cortisol decreased ( F = 23.53 , p < 0.001 ) and subjective relaxation ratings increased ( F = 132.18 , p < 0.001 ) in all 3 groups .
RESULTS	Study participants in the balneotherapy group rated themselves as more relaxed after the intervention as compared to the other groups ( F = 5.22 , p < 0.009 ) .
RESULTS	Participants with a high versus low stress level differed in somatic symptoms and in morning cortisol levels , but showed a similar relaxation response .
CONCLUSIONS	Findings suggest that compared to PMR and resting , balneotherapy seems to be more beneficial with regard to subjective relaxation effects and similarly beneficial with regard to a decrease in salivary cortisol .

###24781936
OBJECTIVE	To characterize visual field ( VF ) loss at the baseline visit and to evaluate VF quality control ( QC ) procedures in the Idiopathic Intracranial Hypertension Treatment Trial ( IIHTT ) .
METHODS	The Visual Field Reading Center ( VFRC ) evaluated 660 baseline VFs ( 1320 hemifields ) from 165 enrolled patients .
METHODS	Three readers independently classified each superior and inferior hemifield and identified any abnormalities .
METHODS	A subset ( 20 % ) of the hemifields was reread to evaluate within - and between-reader agreements .
METHODS	The QC system addressed test parameters , patient data , and shipment errors .
RESULTS	The majority ( 60 % ) of the baseline hemifields consisted of localized nerve fiber bundle-type VF loss .
RESULTS	Approximately one-third ( 31.5 % ) of all the classifications consisted of partial arcuate defects combined with an enlarged blind spot , making this the most common type of hemifield classification .
RESULTS	Inferior hemifield loss was greater than superior loss for both study and nonstudy eyes .
RESULTS	Reader agreements were > 90 % for both inferior and superior hemifields for two out of three readers .
RESULTS	Test-retest reliability agreement for individual readers was 95 % for both hemifields .
RESULTS	There were few QC errors with only 5.48 error points per 100-point VF .
CONCLUSIONS	The most common type of IIHTT baseline hemifield abnormality was a localized nerve fiber bundle-like defect .
CONCLUSIONS	Localized inferior hemifield loss was more common than superior hemifield loss .
CONCLUSIONS	Quality control and within - and between-reader agreement were excellent for the IIHTT ( ClinicalTrials.gov number , NCT01003639 ) .

###24565347
OBJECTIVE	Analgesia after caesarean section is important because postpartum women with pain have difficulty in mobility , which undermines breastfeeding .
OBJECTIVE	Intrathecal morphine provides adequate and prolonged analgesia after cesarean .
OBJECTIVE	The aim of this study was to compare the quality of analgesia provided by two doses of intrathecal morphine and its side effects in patients undergoing cesarean section .
METHODS	The study included 123 pregnant women with gestational age over 38 weeks and scheduled for cesarean section .
METHODS	The women were randomly allocated into two groups to receive either 50 or 100 g of intrathecal morphine ( Group 50/Group 100 ) .
METHODS	All patients were intrathecally anesthetized with 12 mg of 0.5 % hyperbaric bupivacaine .
METHODS	Patients were assessed between the 9 ( th ) and 11 ( th ) hour and the 22 ( nd ) and 24 ( th ) hour after blockade for quality of analgesia , analgesic consumption , side effects , and main cause of discomfort in the first 24 hours after surgery .
RESULTS	There was similarity between groups regarding anthropometric data and obstetric history .
RESULTS	There was no statistical difference in pain intensity between groups .
RESULTS	In both groups , pain was more intense in the first 12 hours after anesthesia ( p < 0.001 ) .
RESULTS	Tramadol hydrochloride consumption and time to first dose were similar in both groups .
RESULTS	Pruritus was the most common side effect , with statistically higher incidence in Group 100 ( p = 0.026 ) .
CONCLUSIONS	Intrathecal morphine 50 g provides the same quality of analgesia as 100 g , with a lower incidence of side effects .

###24605812
BACKGROUND	Unwanted submental fat ( SMF ) may result in an unattractive chin profile and dissatisfaction with appearance .
BACKGROUND	An approved and rigorously tested non-surgical method for SMF reduction is lacking .
OBJECTIVE	To evaluate the efficacy and safety of ATX-101 for the pharmacological reduction of unwanted SMF in a phase III randomized , double-blind , placebo-controlled study .
METHODS	Patients ( n = 360 ) with moderate or severe SMF were randomized to receive ATX-101 1 or 2 mg/cm ( 2 ) or placebo injected into their SMF for up to four treatments ~ 28 days apart , with a 12-week follow-up .
METHODS	Coprimary efficacy endpoints were the proportions of treatment responders , defined as a 1-point reduction in SMF on the Clinician-Reported Submental Fat Rating Scale ( CR-SMFRS ) , and those satisfied with their appearance in association with their face and chin after treatment on the Subject Self-Rating Scale ( SSRS score 4 ) .
METHODS	Secondary efficacy endpoints included a 1-point improvement in SMF on the Patient-Reported Submental Fat Rating Scale ( PR-SMFRS ) and changes in the Patient-Reported Submental Fat Impact Scale ( PR-SMFIS ) .
METHODS	Additional patient-reported outcomes and changes in the Skin Laxity Rating Scale were recorded .
METHODS	Adverse events ( AEs ) and laboratory test results were monitored .
RESULTS	Compared with placebo , a greater proportion of patients treated with ATX-101 1 and 2 mg/cm ( 2 ) showed a 1-point improvement in CR-SMFRS ( 58.3 % and 62.3 % , respectively , vs. 34.5 % with placebo ; P < 0.001 ) and patient satisfaction ( SSRS score 4 ) with the appearance of their face and chin ( 68.3 % and 64.8 % , respectively , vs. 29.3 % ; P < 0.001 ) .
RESULTS	Patient-reported secondary efficacy endpoints showed significant improvements in SMF severity ( PR-SMFRS ; P = 0.009 for ATX-101 1 mg/cm ( 2 ) , P < 0.001 for ATX-101 2 mg/cm ( 2 ) vs. placebo ) and emotions and perceived self-image ( PR-SMFIS ; P < 0.001 ) .
RESULTS	No overall worsening of skin laxity was observed .
RESULTS	AEs were mostly transient , mild to moderate in intensity and localized to the treatment area .
CONCLUSIONS	ATX-101 was effective and well tolerated , and may be an alternative to surgery for patients desiring improvement of their submental profile .

###25039412
BACKGROUND	Transnasal endoscopy ( TNE ) with ultrathin endoscopes has been advocated as an attractive alternative , for diagnostic upper endoscopy .
OBJECTIVE	To assess tolerability , acceptability and quality of TNE , in comparison with standard upper endoscopy ( SOGD , standard oesophago-gastro-duodenoscopy ) under local anaesthetic .
METHODS	We prospectively recruited 157 patients ( 83 females/74 males ) mean age 57years .
METHODS	The Fujinon EG530N ( 5.9 mm ) and EG530WR ( 9.4 mm ) endoscopes were used .
METHODS	The endoscopist and all patients completed detailed questionnaires regarding tolerability , acceptance and quality of endoscopy using standard visual analogue scales ( VAS ) .
METHODS	Oxygen saturation ( SaO2 ) , heart rate ( HR ) and systolic blood pressure ( SBP ) were recorded .
METHODS	Quality of biopsies was evaluated .
RESULTS	Analysis included 161 procedures ( TNE :79 , SOGD :82 ) with duodenal intubation achieved in all patients .
RESULTS	VAS scores for patient comfort were significantly better in the TNE group ( 7.3 vs. 5.3 respectively , P < 0.001 ) .
RESULTS	Twenty patients with previous experience of standard endoscopy were randomised to TNE and 19 of them ( 95.5 % ) preferred the TNE .
RESULTS	Gagging was significantly less in the TNE group ( 0.12 vs. 3.41 respectively , P < 0.001 ) .
RESULTS	Cardiovascular stress was significantly less in the TNE group irrespective of the degree of gagging or comfort .
RESULTS	TNE biopsies were smaller , but adequate for definitive diagnosis , similarly to standard endoscopy .
CONCLUSIONS	Transnasal endoscopy is superior to SOGD in terms of comfort and patient acceptance with significantly less cardiovascular stress .
CONCLUSIONS	TNE can routinely be used as alternative to SOGD under local anaesthetic , for diagnosis and should be preferentially offered in cardiorespiratory compromised patients .

###25905534
OBJECTIVE	To determine whether glutamate-evoked jaw muscle pain is altered by the temperature of the solution injected .
METHODS	Sixteen healthy volunteers participated and received injections of hot ( 48C ) , neutral ( 36C ) , or cold ( 3C ) solutions ( 0.5 mL ) of glutamate or isotonic saline into the masseter muscle .
METHODS	Pain intensity was assessed with an electronic visual analog scale ( eVAS ) .
METHODS	Numeric rating scale ( NRS ) scores of unpleasantness and temperature perception , pain-drawing areas , and pressure pain thresholds ( PPTs ) were also measured .
METHODS	Participants filled out the McGill Pain Questionnaire ( MPQ ) .
METHODS	Two-way or three-way repeated measures ANOVA were used for data analyses .
RESULTS	Injection of hot glutamate and cold glutamate solutions significantly increased and decreased , respectively , the peak pain intensity compared with injection of neutral glutamate solution .
RESULTS	The duration of glutamate-evoked pain was significantly longer when hot glutamate was injected than when cold glutamate was injected .
RESULTS	No significant effect of temperature on pain intensity was observed when isotonic saline was injected .
RESULTS	No effect of solution temperature was detected on unpleasantness , heat perception , cold perception , area of pain drawings , or PPTs .
RESULTS	There was a significantly greater use of the `` numb '' term in the MPQ to describe the injection of cold solutions compared to the injection of both neutral and hot solutions .
CONCLUSIONS	Glutamate-evoked jaw muscle pain was significantly altered by the temperature of the injection solution .
CONCLUSIONS	Although temperature perception in the jaw muscle is poor , pain intensity is increased when the muscle tissue temperature is elevated .

###24717470
OBJECTIVE	Vascular dysfunction plays a central role in sepsis , and it is characterized by hypotension and hyporesponsiveness to vasoconstrictors .
OBJECTIVE	Nitric oxide is regarded as a central element of sepsis vascular dysfunction .
OBJECTIVE	The high amounts of nitric oxide produced during sepsis are mainly derived from the inducible isoform of nitric oxide synthase 2 .
OBJECTIVE	We have previously shown that nitric oxide synthase 2 levels decrease in later stages of sepsis , whereas levels and activity of soluble guanylate cyclase increase .
OBJECTIVE	Therefore , we studied the putative role of other relevant nitric oxide sources , namely , the neuronal ( nitric oxide synthase 1 ) isoform , in sepsis and its relationship with soluble guanylate cyclase .
OBJECTIVE	We also studied the consequences of nitric oxide synthase 1 blockade in the hyporesponsiveness to vasoconstrictors .
METHODS	Randomized controlled prospective experimental study .
METHODS	Academic research laboratory .
METHODS	Female Wistar rats submitted to cecal ligation and puncture method .
METHODS	1 ) Six , 12 , and 24 hours after cecal ligation and puncture , vascular reactivity to phenylephrine ( 3 and 30 nmol/kg ) before and after 7-nitroindazole ( 45 mol/kg , s.c. ) or aminoguanidine ( 30 mol/kg , s.c. ) administration was evaluated .
METHODS	2 ) Protein levels and interaction between nitric oxide synthase 1 and soluble guanylate cyclase were determined .
METHODS	3 ) Six , 12 , and 24 hours after cecal ligation and puncture , thoracic aorta segments were stimulated with phenylephrine in the presence or absence of 7-nitroindazole and cyclic guanosine monophosphate accumulation was determined .
METHODS	4 ) After 24 hours of cecal ligation and puncture , norepinephrine was infused ( 10 g/kg/min ) in the presence or absence of 7-nitroindazole or S-methyl-L-thiocitrulline ( 1 mol/kg , IV ) and mean arterial pressure was registered .
RESULTS	1 ) Both nitric oxide synthase 1 and soluble guanylate cyclase are expressed in higher levels in vascular tissues during sepsis ; 2 ) both proteins physically interact and nitric oxide synthase 1 blockade inhibits cyclic guanosine monophosphate production ; 3 ) pharmacological blockade of nitric oxide synthase 1 using 7-nitroindazole or S-methyl-L-thiocitrulline reverts the hyporesponsiveness to phenylephrine and increases the vasoconstrictor effect of norepinephrine and phenylephrine .
CONCLUSIONS	Sepsis induces increased expression and physical association of nitric oxide synthase 1/soluble guanylate cyclase and a higher production of cyclic guanosine monophosphate that together may help explain sepsis-induced vascular dysfunction .
CONCLUSIONS	In addition , selective inhibition of nitric oxide synthase 1 restores the responsiveness to vasoconstrictors .
CONCLUSIONS	Therefore , inhibition of nitric oxide synthase 1 ( and possibly soluble guanylate cyclase ) may represent a valuable alternative to restore the effectiveness of vasopressor agents during late sepsis .

###25188603
METHODS	Retrospective cohort study .
OBJECTIVE	To identify risk factors for poor short-term outcomes after vertebral augmentation procedures .
BACKGROUND	Vertebral compression fractures are the most common fractures of osteoporosis and are frequently treated with vertebroplasty or kyphoplasty .
BACKGROUND	There is a shortage of information about risk factors for short-term , general health outcomes after vertebral augmentation in the literature .
METHODS	Patients older than 65 years who underwent vertebroplasty or kyphoplasty in 2011 and 2012 were identified from the American College of Surgeons National Surgical Quality Improvement Program database .
METHODS	Patient characteristics were tested for association with 30-day adverse events , mortality , and readmission using bivariate and multivariate analyses .
RESULTS	A total of 850 patients met inclusion criteria .
RESULTS	The average age was 78.911.7 years ( meanstandard deviation ) and females made up 70.8 % of the cohort .
RESULTS	Of these patients , 9.5 % had any adverse event ( AAE ) , and 6.6 % had a serious adverse event ( SAE ) .
RESULTS	Death occurred in 1.5 % of patients , and 10.8 % were readmitted within the first 30 postoperative days.On multivariate analysis , AAE and SAE were both significantly associated with American Society of Anesthesiologists class 4 ( AAE : odds ratio [ OR ] = 2.7 , P = 0.013 ; SAE : OR = 2.5 , P = 0.040 ) and inpatient status before procedure ( AAE : OR = 2.7 , P < 0.001 , SAE : OR = 2.4 , P = 0.003 ) .
RESULTS	Increased postoperative mortality rate was associated with American Society of Anesthesiologists class 4 ( OR = 6.4 , P = 0.024 ) and the use of nongeneral anesthesia ( OR = 4.0 , P = 0.022 ) .
RESULTS	Readmission was associated with history of pulmonary disease ( OR = 2.0 , P = 0.005 ) and inpatient status before procedure ( OR = 1.9 , P = 0.005 ) .
CONCLUSIONS	Adverse general health outcomes were relatively common , and the factors identified in the earlier text associated with patient outcomes after vertebral augmentation may be useful for preoperative discussions and counseling .
METHODS	3 .

###25891551
OBJECTIVE	To study the association between changes in brain magnetic resonance imaging ( MRI ) and clinical outcomes in early MS.
METHODS	MS patients within 12 months of onset were enrolled and followed up to 3 years .
METHODS	Clinical measures included Symbol Digit Modalities Test ( SDMT ) , MS Functional Composite ( MSFC ) and low contrast letter acuity ( LCLA ) .
METHODS	MRI outcomes included brain volume changes measured by SIENA and SIENAX normalized measurements [ brain parenchymal volume ( BPV ) , normal-appearing white and gray matter volume ( NAWMV and GMV ) and T2 lesion volume ( T2LV ) ] .
METHODS	Mixed model regression measured time trends and associations between imaging and clinical outcome .
RESULTS	Forty-three patients were enrolled within 7.54.9 months of onset .
RESULTS	Baseline T2 lesion volume predicted subsequent changes in Paced Auditory Serial Addition Test ( PASAT ) ( p = 0.004 ) , whereas baseline measures of atrophy including BPV , GMV , and NAWMV predicted longitudinal changes in MSFC ( p = 0.016 , p = 0.040 , p = 0.021 , respectively ) and Timed-25 Foot Walk ( p < 0.05 ) .
RESULTS	Each 1 % decrease in SIENA was associated with 1.14 point decrease in SDMT score ( p = 0.03 ) .
RESULTS	Each 1 % decrease in brain volume SIENA was associated with almost 1.5 letters decrease on LCLA ( p = 0.02 ) .
CONCLUSIONS	Measures of lesion volume and overall brain volume were associated with different long-term clinical outcome measures in early MS.

###25240821
BACKGROUND	VEGFR-2 has a role in gastric cancer pathogenesis and progression .
BACKGROUND	We assessed whether ramucirumab , a monoclonal antibody VEGFR-2 antagonist , in combination with paclitaxel would increase overall survival in patients previously treated for advanced gastric cancer compared with placebo plus paclitaxel .
METHODS	This randomised , placebo-controlled , double-blind , phase 3 trial was done at 170 centres in 27 countries in North and South America , Europe , Asia , and Australia .
METHODS	Patients aged 18 years or older with advanced gastric or gastro-oesophageal junction adenocarcinoma and disease progression on or within 4 months after first-line chemotherapy ( platinum plus fluoropyrimidine with or without an anthracycline ) were randomly assigned with a centralised interactive voice or web-response system in a 1:1 ratio to receive ramucirumab 8 mg/kg or placebo intravenously on days 1 and 15 , plus paclitaxel 80 mg/m ( 2 ) intravenously on days 1 , 8 , and 15 of a 28-day cycle .
METHODS	A permuted block randomisation , stratified by geographic region , time to progression on first-line therapy , and disease measurability , was used .
METHODS	The primary endpoint was overall survival .
METHODS	Efficacy analysis was by intention to treat , and safety analysis included all patients who received at least one treatment with study drug .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01170663 , and has been completed ; patients who are still receiving treatment are in the extension phase .
RESULTS	Between Dec 23 , 2010 , and Sept 23 , 2012 , 665 patients were randomly assigned to treatment-330 to ramucirumab plus paclitaxel and 335 to placebo plus paclitaxel .
RESULTS	Overall survival was significantly longer in the ramucirumab plus paclitaxel group than in the placebo plus paclitaxel group ( median 96 months [ 95 % CI 85-108 ] vs 74 months [ 95 % CI 63-84 ] , hazard ratio 0807 [ 95 % CI 0678-0962 ] ; p = 0017 ) .
RESULTS	Grade 3 or higher adverse events that occurred in more than 5 % of patients in the ramucirumab plus paclitaxel group versus placebo plus paclitaxel included neutropenia ( 133 [ 41 % ] of 327 vs 62 [ 19 % ] of 329 ) , leucopenia ( 57 [ 17 % ] vs 22 [ 7 % ] ) , hypertension ( 46 [ 14 % ] vs eight [ 2 % ] ) , fatigue ( 39 [ 12 % ] vs 18 [ 5 % ] ) , anaemia ( 30 [ 9 % ] vs 34 [ 10 % ] ) , and abdominal pain ( 20 [ 6 % ] vs 11 [ 3 % ] ) .
RESULTS	The incidence of grade 3 or higher febrile neutropenia was low in both groups ( ten [ 3 % ] vs eight [ 2 % ] ) .
CONCLUSIONS	The combination of ramucirumab with paclitaxel significantly increases overall survival compared with placebo plus paclitaxel , and could be regarded as a new standard second-line treatment for patients with advanced gastric cancer .
BACKGROUND	Eli Lilly and Company .

###25510746
OBJECTIVE	To evaluate the effect of statin treatment on strut coverage after drug-eluting stent ( DES ) implantation .
METHODS	In this study , 60 patients were randomly assigned to undergo sirolimus-eluting stent ( SES ) or biolimus-eluting stent ( BES ) implantation , after which patients were randomly treated with pitavastatin 2 mg or pravastatin 20 mg for 6 months .
METHODS	The degree of strut coverage was assessed by 6-month follow-up optical coherence tomography , which was performed in 52 DES-implanted patients .
RESULTS	The percentages of uncovered struts were 19.414.7 % in pitavastatin-treated patients ( n = 25 ) and 19.115.2 % in pravastatin-treated patients ( n = 27 ; p = 0.927 ) .
RESULTS	A lower percentage of uncovered struts was significantly correlated with a lower follow-up low-density lipoprotein ( LDL ) cholesterol level ( r = 0.486 ; p = 0.009 ) and a greater decline of the LDL cholesterol level ( r = -0.456 ; p = 0.015 ) in SES-implanted patients , but not in BES-implanted patients .
RESULTS	In SES-implanted patients , the percentage of uncovered struts was significantly lower among those with LDL cholesterol levels of less than 70 mg/dL after 6 months of follow-up ( p = 0.025 ) , but no significant difference in this variable according to the follow-up LDL cholesterol level was noted among BES-implanted patients ( p = 0.971 ) .
CONCLUSIONS	Lower follow-up LDL cholesterol levels , especially those less than 70 mg/dL , might have a protective effect against delayed strut coverage after DES implantation .
CONCLUSIONS	This vascular healing effect of lower LDL cholesterol levels could differ according to the DES type .

###25049325
OBJECTIVE	This study evaluated the efficacy of a cancer geneticsspecific questionnaire in facilitating communication about , awareness of , and management of psychosocial problems , as well as in lowering distress levels .
METHODS	Individuals referred to genetic counseling for cancer at two family cancer clinics in The Netherlands were randomly assigned to an intervention or a control group .
METHODS	All participants completed the psychosocial questionnaire before counseling .
METHODS	In the intervention group , the counselors received the results of this questionnaire before the counseling session .
METHODS	All sessions were audiotaped for content analysis .
METHODS	Primary outcomes were the frequency with which psychosocial problems were discussed , the genetic counselors awareness of these problems , and their management .
METHODS	Secondary outcomes included cancer worries and psychological distress , duration and dynamics of the counseling , and satisfaction .
RESULTS	The frequency with which psychosocial problems were discussed with 246 participating counselees was significantly higher in the intervention group ( n = 127 ) than in the control group ( n = 119 ; P = .004 ) , as was the counselors awareness of psychosocial problems regarding hereditary predisposition ( P < .001 ) , living with cancer ( P = .01 ) , and general emotions ( P < .001 ) .
RESULTS	Counselors initiated more discussion of psychosocial problems in the intervention group ( P < .001 ) , without affecting the length of the counseling session .
RESULTS	No significant differences were found on management ( P = .19 ) .
RESULTS	The intervention group reported significantly lower levels of cancer worries ( p = .005 ) and distress ( p = .02 ) after counseling .
CONCLUSIONS	The routine assessment of psychosocial problems by questionnaire facilitates genetic counselors recognition and discussion of their clients psychosocial problems and reduces clients distress levels .

###25306925
OBJECTIVE	To pilot the feasibility of a prenatal lifestyle intervention to modify physical activity and diet among pregnant overweight and obese Hispanic women , with the aim of reducing risk factors for gestational diabetes mellitus .
METHODS	Women were randomized either to a lifestyle intervention ( n = 33 , 48.5 % ) , consisting of a culturally and linguistically modified , motivationally targeted , individually tailored 6-month prenatal programme , or to standard care ( n = 35 , 51.5 % ) .
METHODS	Bilingual and bicultural health educators encouraged women to achieve guidelines for physical activity , decrease saturated fat and increase dietary fibre .
METHODS	Outcomes included gestational weight gain , infant birth weight and biomarkers associated with insulin resistance .
RESULTS	Patient retention up to delivery was 97 % in both study groups .
RESULTS	The lifestyle intervention attenuated the pregnancy-associated decline in moderate-intensity physical activity , but differences between groups were not significant ( mean se -23.4 16.6 vs -27.0 16.2 metabolic equivalent of task h/week ; P = 0.88 ) .
RESULTS	Vigorous-intensity activity increased during the course of pregnancy in the lifestyle intervention group ( mean se 1.6 0.8 metabolic equivalent of task h/week ) and declined in the standard care group ( -0.8 0.8 metabolic equivalent of task h/week ; P = 0.04 ) .
RESULTS	The lifestyle intervention group also had slightly lower gestational weight gain and infant birth weights compared with the standard care group ; however , these differences were not statistically significant .
RESULTS	There were no statistically significant differences in biomarkers of insulin resistance between groups .
CONCLUSIONS	Findings suggest that a motivationally matched lifestyle intervention is feasible and may help attenuate pregnancy-related decreases in vigorous physical activity in a population of overweight and obese Hispanic women .
CONCLUSIONS	The intervention protocol can readily be translated into clinical practice in underserved and minority populations .

###24332357
BACKGROUND	Chronic ischemia related occult systolic dysfunction of the right ventricle is difficult to detect using traditional echocardiography .
BACKGROUND	The aim of this study was to verify the diagnostic value of speckle-tracking echocardiography in proximal right coronary artery ( pRCA ) lesion-induced right ventricular ( RV ) occult dysfunction .
METHODS	One hundred forty-two patients undergoing elective coronary angiography for suspected coronary artery disease were divided into two groups according to involvement of the right coronary artery .
METHODS	In further analysis , significant stenosis before the acute marginal branch was defined as pRCA involvement and compared with a control group .
METHODS	Global longitudinal strain and RV free wall longitudinal train ( RVLS-FW ) were measured using speckle-tracking echocardiography .
METHODS	Other traditional parameters to evaluate RV function were also measured .
RESULTS	Eighty-seven patients in the right coronary artery group ( 61.2 % ) displayed significant decreases in the magnitudes of both global longitudinal strain ( -13.65 3.83 % vs -15.69 4.37 % , P = .04 ) and RVLS-FW ( -16.04 5.4 % vs -21.18 4.6 % , P = .04 ) , independent of other parameters .
RESULTS	Conversely , when focusing on pRCA involvement , only RVLS-FW showed significant attenuation in the group with pRCA involvement ( -14.26 4.32 % vs -19.96 4.8 % , P = .001 ) .
RESULTS	On multivariate analysis , RVLS-FW was still independently lower in the group with pRCA involvement ( odds ratio , 1.07 ; 95 % confidence interval , 1.01-1 .14 ; P = .02 ) .
CONCLUSIONS	The results of this study show that RVLS-FW was independently impaired in patients with coronary artery disease with right coronary artery stenosis , especially with involvement of the acute marginal branches .
CONCLUSIONS	RV strain can be used to detect occult RV dysfunction in patients with stable coronary artery disease .

###26061837
BACKGROUND	Young women attending university are at substantial risk for being sexually assaulted , primarily by male acquaintances , but effective strategies to reduce this risk remain elusive .
METHODS	We randomly assigned first-year female students at three universities in Canada to the Enhanced Assess , Acknowledge , Act Sexual Assault Resistance program ( resistance group ) or to a session providing access to brochures on sexual assault , as was common university practice ( control group ) .
METHODS	The resistance program consists of four 3-hour units in which information is provided and skills are taught and practiced , with the goal of being able to assess risk from acquaintances , overcome emotional barriers in acknowledging danger , and engage in effective verbal and physical self-defense .
METHODS	The primary outcome was completed rape , as measured by the Sexual Experiences Survey-Short Form Victimization , during 1 year of follow-up .
RESULTS	A total of 451 women were assigned to the resistance group and 442 women to the control group .
RESULTS	Of the women assigned to the resistance group , 91 % attended at least three of the four units .
RESULTS	The 1-year risk of completed rape was significantly lower in the resistance group than in the control group ( 5.2 % vs. 9.8 % ; relative risk reduction , 46.3 % [ 95 % confidence interval , 6.8 to 69.1 ] ; P = 0.02 ) .
RESULTS	The 1-year risk of attempted rape was also significantly lower in the resistance group ( 3.4 % vs. 9.3 % , P < 0.001 ) .
CONCLUSIONS	A rigorously designed and executed sexual assault resistance program was successful in decreasing the occurrence of rape , attempted rape , and other forms of victimization among first-year university women .
CONCLUSIONS	( Funded by the Canadian Institutes of Health Research and the University of Windsor ; SARE ClinicalTrials.gov number , NCT01338428 . )

###24810252
BACKGROUND	Lace-up ankle braces reduce the incidence of ankle sprains and have been hypothesized to do so through both mechanical and neuromuscular mechanisms .
OBJECTIVE	To determine the effect of lace-up ankle braces on surface electromyography ( sEMG ) measures during walking in adults with chronic ankle instability ( CAI ) .
METHODS	Randomized crossover .
METHODS	Laboratory .
METHODS	Fifteen adults with CAI .
METHODS	Surface EMG activity was recorded from the anterior tibialis , peroneus longus , lateral gastrocnemius , rectus femoris , biceps femoris and gluteus medius during treadmill walking with and without lace-up ankle braces .
METHODS	The dependent variables were sEMG amplitude 100 ms pre - and 200 ms post-initial contact , time of activation relative to initial contact , and percent of activation across the stride cycle .
RESULTS	When compared to no brace , ankle bracing resulted in lower pre-contact amplitude of the peroneus longus ( p = 0.02 ) .
RESULTS	The anterior tibialis , peroneus longus , rectus femoris , and gluteus medius were activated later relative to initial contact ( p < 0.03 ) .
RESULTS	The peroneus longus and rectus femoris were activated for a shorter percentage of the stride cycle ( p < 0.05 ) .
CONCLUSIONS	Braces cause a change in neuromuscular activity during walking .
CONCLUSIONS	Clinicians should be aware of these changes when prescribing braces , as it may relate to the mechanism in which braces decrease sprains .

###25348033
BACKGROUND	Osteoarthritis ( OA ) is a heterogeneous group of conditions with disturbed integrity of articular cartilage and changes in the underlying bone .
BACKGROUND	The pathogenesis of OA is multifactorial and not just a disease of older people .
BACKGROUND	Hydroxychloroquine ( HCQ ) is a disease-modifying anti-rheumatic drug ( DMARD ) typically used for the treatment of various rheumatic and dermatologic diseases .
BACKGROUND	Three studies of HCQ in OA , including one abstract and one letter , are available and use a wide variety of outcome measures in small patient populations .
BACKGROUND	Despite initial evidence for good efficacy of HCQ , there has been no randomized , double-blind , and placebo-controlled trial in a larger patient group .
BACKGROUND	In the European League Against Rheumatism ( EULAR ) , evidence-based recommendations for the management of hand OA , HCQ was not included as a therapeutic option because of the current lack of randomized clinical trials .
METHODS	OA TREAT is an investigator-initiated , multicenter , randomized , double-blind , placebo-controlled trial .
METHODS	A total of 510 subjects with inflammatory and erosive hand OA , according to the classification criteria of the American College of Rheumatology ( ACR ) , with recent X-ray will be recruited across outpatient sites , hospitals and universities in Germany .
METHODS	Patients are randomized 1:1 to active treatment ( HCQ 200 to 400 mg per day ) or placebo for 52 weeks .
METHODS	Both groups receive standard therapy ( non-steroidal anti-inflammatory drugs [ NSAID ] , coxibs ) for OA treatment , taken steadily two weeks before enrollment and continued further afterwards .
METHODS	If disease activity increases , the dose of NSAID/coxibs can be increased according to the drug recommendation .
METHODS	The co-primary clinical endpoints are the changes in Australian-Canadian OA Index ( AUSCAN , German version ) dimensions for pain and hand disability at week 52 .
METHODS	The co-primary radiographic endpoint is the radiographic progression from baseline to week 52 .
METHODS	A multiple endpoint test and analysis of covariance will be used to compare changes between groups .
METHODS	All analyses will be conducted on an intention-to-treat basis .
CONCLUSIONS	The OA TREAT trial will examine the clinical and radiological efficacy and safety of HCQ as a treatment option for inflammatory and erosive OA over 12 months .
CONCLUSIONS	OA TREAT focuses on erosive hand OA in contrast to other current studies on symptomatic hand OA , for example , HERO [ Trials 14:64 , 2013 ] .
BACKGROUND	ISRCTN46445413 , date of registration : 05-10-2011 .

###24331637
BACKGROUND	Despite the often social nature of smoking , relatively little research has been conducted on the relationship between smoking and social anxiety disorder ( SAD ) .
METHODS	Participants ( N = 99 ) included 34 smokers without current mental health disorders , 37 smokers with SAD , and 28 smokers who met criteria for other anxiety disorder diagnoses ( e.g. , panic disorder or generalized anxiety disorder , but not SAD ) .
METHODS	Nicotine and placebo patches were administered to participants in a counterbalanced manner across two assessment days .
METHODS	Urge and craving were assessed before and after a 5-h nicotine absorption/deprivation period .
RESULTS	Compared to smokers without current mental health disorders , smokers with SAD did not report greater nicotine dependence , but did endorse greater motivation to use nicotine to avoid negative outcomes .
RESULTS	In addition , after controlling for demographic variables , smoking characteristics , pre-deprivation urge and craving , and other anxiety/depression symptoms , social anxiety symptoms uniquely predicted urge and craving in the placebo patch condition ; however , social anxiety had no influence on urge and craving in the nicotine patch condition .
CONCLUSIONS	These findings suggest that one potential reason that smokers with SAD may have worse cessation outcomes is that they may experience higher levels of craving and urge to smoke during quit attempts .
CONCLUSIONS	Thus , during a quit attempt , particularly in the absence of nicotine replacement therapy , smokers with SAD are likely to benefit from additional treatment aimed at managing or reducing their social anxiety symptoms .

###24419108
OBJECTIVE	To analyze recurrence patterns in patients with cancer of the esophagus or gastroesophageal junction treated with either preoperative chemoradiotherapy ( CRT ) plus surgery or surgery alone .
METHODS	Recurrence pattern was analyzed in patients from the previously published CROSS I and II trials in relation to radiation target volumes .
METHODS	CRT consisted of five weekly courses of paclitaxel and carboplatin combined with a concurrent radiation dose of 41.4 Gy in 1.8-Gy fractions to the tumor and pathologic lymph nodes with margin .
RESULTS	Of the 422 patients included from 2001 to 2008 , 418 were available for analysis .
RESULTS	Histology was mostly adenocarcinoma ( 75 % ) .
RESULTS	Of the 374 patients who underwent resection , 86 % were allocated to surgery and 92 % to CRT plus surgery .
RESULTS	On January 1 , 2011 , after a minimum follow-up of 24 months ( median , 45 months ) , the overall recurrence rate in the surgery arm was 58 % versus 35 % in the CRT plus surgery arm .
RESULTS	Preoperative CRT reduced locoregional recurrence ( LRR ) from 34 % to 14 % ( P < .001 ) and peritoneal carcinomatosis from 14 % to 4 % ( P < .001 ) .
RESULTS	There was a small but significant effect on hematogenous dissemination in favor of the CRT group ( 35 % v 29 % ; P = .025 ) .
RESULTS	LRR occurred in 5 % within the target volume , in 2 % in the margins , and in 6 % outside the radiation target volume .
RESULTS	In 1 % , the exact site in relation to the target volume was unclear .
RESULTS	Only 1 % had an isolated infield recurrence after CRT plus surgery .
CONCLUSIONS	Preoperative CRT in patients with esophageal cancer reduced LRR and peritoneal carcinomatosis .
CONCLUSIONS	Recurrence within the radiation target volume occurred in only 5 % , mostly combined with outfield failures .

###25543425
OBJECTIVE	To explore the efficacy and feasibility of dog days moxibustion plaster therapy in treatment of allergic rhinitis of different patterns/syndromes .
METHODS	Allergic rhinitis of lung deficiency and invasion of cold , spleen qi deficiency and kidney yang deficiency , 56 patients for each pattern/syndrome were randomized into a plaster therapy group and a nasal spray group , 28 cases in each one .
METHODS	In the plaster therapy group , according to the pattern/syndrome differentiation , with literature retrieval method , 3 acupoints of high frequency utility in clinic were selected as one group in acupoint plaster therapy .
METHODS	For lung deficiency and invasion of cold pattern/syndrome , Feishu ( BL 13 ) , Fengmen ( BL 12 ) and Hegu ( LI 4 ) were selected .
METHODS	For spleen qi deficiency pattern/syndrome , Pishu ( BL 21 ) , Zusanli ( ST 36 ) and Dazhui ( GV 14 ) were selected .
METHODS	For kidney yang deficiency pattern / syndrome , Shenshu ( BL 23 ) , Dingchuan ( EX-B 1 ) and Bailao ( EX-HN 15 ) were selected .
METHODS	Separately , on July 13 , 2013 , July 23 , 2013 , August 2 , 2013 and August 12 , 2013 , the aucpoint plaster therapy was applied , 2 to 4 h ( 1 to 2 h for children ) each time .
METHODS	In the nasal spray group , beclometasone dipropionate aqueous nasal spray , 2 presses one nostril each time , 2 to 3 times a day , continuously for 4 weeks .
METHODS	The symptom score and efficacy were compared before and after treatment in the patients of the two groups .
RESULTS	The symptom scores of 3 patterns/syndromes were all apparently improved after treatment as compared with those before treatment in the patients of the two groups ( all P < 0.05 ) , and the result in the plaster therapy group was better than that of the nasal spray group ( P < 0.05 , P < 0.01 ) .
RESULTS	For lung deficiency and invasion of cold pattern/syndrome , the total effective rate was 87.3 % ( 20/24 ) in the plaster therapy group , better than 84.6 % ( 22/26 ) in the nasal spray group ( P < 0.05 ) .
RESULTS	For spleen qi deficiency pattern/syndrome , the total effective rate was 83.3 % ( 20/24 ) in the plaster therapy group , obviously better than 76.9 % ( 22/26 ) in the nasal spray group ( P < 0.05 ) .
RESULTS	For kidney yang deficiency pattern/syndrome , the total effective rate was 79.2 % ( 19/24 ) in the plaster therapy group , better than 76.9 % ( 22/26 ) in the nasal spray group ( P < 0.05 ) .
CONCLUSIONS	The dog days moxibustion plaster therapy achieves definite efficacy on allergic rhinitis at the acupoints selected based on the differentiation of different patterns/syndromes and the efficacy is better than beclometasone dipropionate aqueous nasal spray .

###24445147
BACKGROUND	Cytotoxic chemotherapy is widely used for advanced , unresectable pancreatic and other gastrointestinal foregut neuroendocrine tumours ( NETs ) and the most commonly used regimen combines 5-fluorouracil with streptozocin .
BACKGROUND	The NET01 trial was designed to investigate whether capecitabine combined with streptozocin was an acceptable regimen with or without adding cisplatin .
METHODS	Patients with advanced , unresectable NETs of pancreatic , gastrointestinal foregut or unknown primary site were randomised to receive three-weekly capecitabine ( Cap ) 625 mg/m ( 2 ) twice daily orally , streptozocin ( Strep ) 1.0 g/m ( 2 ) intravenously on day 1 , with or without cisplatin ( Cis ) 70 mg/m ( 2 ) intravenously on day 1 .
METHODS	The primary outcome measure was objective response .
METHODS	Secondary outcome measures included progression-free and overall survival , quality of life , toxicity and biochemical response .
RESULTS	86 ( 44 CapStrep , 42 CapStrepCis ) patients were randomised .
RESULTS	Best objective response rate was 12 % ( 95 % confidence interval ( CI ) = 2-22 % ) with CapStrep and 16 % ( 95 % CI = 4-27 .4 % ) with CapStrepCis .
RESULTS	Disease-control rate was 80 % with CapStrep and 74 % with CapStrepCis .
RESULTS	The estimated median progression-free and overall survival were 10.2 and 26.7 months for CapStrep and 9.7 and 27.5 months for CapStrepCis .
RESULTS	44 % of CapStrep and 68 % of CapStrepCis patients experienced grade 3 adverse events .
CONCLUSIONS	The efficacies of the novel CapStrepCis regimens were very similar .
CONCLUSIONS	CapStrep was better tolerated than CapStrepCis .
CONCLUSIONS	The trial was registered as EudraCT : 2004-005202-71 and ISRCTN : 35124268 .

###25444990
OBJECTIVE	The Trendelenburg position has a dramatic effect on circulation , consequently increasing cerebral and intraocular pressure .
OBJECTIVE	We evaluated whether modifying the Trendelenburg position would minimize the increase in intraocular pressure .
METHODS	In this prospective , randomized , controlled study we compared intraocular pressure in patients undergoing robot-assisted laparoscopic radical prostatectomy while in the Trendelenburg position or the modified Z Trendelenburg position .
METHODS	In group 1 intraocular pressure , blood pressure and endotracheal CO2 were measured in the patient at anesthesia induction ( time 1 ) , before positioning ( time 2 ) , and while in the Trendelenburg position ( time 3 ) and in the modified Z Trendelenburg position ( time 4 ) .
METHODS	They were also measured after pneumoperitoneum ( time 5 ) , every 30 minutes ( times 6 to 16 ) , while supine at the end of pneumoperitoneum ( time 17 ) and before awakening ( time 18 ) .
METHODS	We modified the Trendelenburg position by placing the head and shoulders horizontally .
RESULTS	Group 1 included 29 patients in the modified Z Trendelenburg position .
RESULTS	Group 2 included 21 patients in the Trendelenburg position .
RESULTS	No difference was found in patient demographics or surgical outcomes .
RESULTS	Median intraocular pressure was in the low normal range at times 1 and 2 , and increased in time 3 in each group .
RESULTS	From time 4 intraocular pressure decreased and at all time points it was significantly lower in group 1 by a mean of 4.61 mm Hg ( 95 % CI -6.90 -2.30 , p < 0.001 ) .
RESULTS	At time 17 mean intraocular pressure decreased to normal ( 19.6 mm Hg ) in group 1 but remained in the hypertensive range ( 24.9 mm Hg ) in group 2 .
RESULTS	At time 18 mean intraocular pressure was 17 mm Hg in each group .
RESULTS	Blood pressure was significantly lower in group 1 with a mean reduction in systolic and diastolic pressure of 6.3 and 4.3 mm Hg , respectively .
CONCLUSIONS	Our results suggest that modifying the Trendelenburg position during robot-assisted laparoscopic radical prostatectomy has a significant positive effect on patient neuro-ocular safety by lowering intraocular pressure and accelerating its recovery to the normal range without affecting the operation .

###24453079
OBJECTIVE	To assess whether bezafibrate increases fatty acid oxidation ( FAO ) and lowers heart rate ( HR ) during exercise in patients with carnitine palmitoyltransferase ( CPT ) II and very long-chain acyl-CoA dehydrogenase ( VLCAD ) deficiencies .
METHODS	This was a 3-month , randomized , double-blind , crossover study of bezafibrate in patients with CPT II ( n = 5 ) and VLCAD ( n = 5 ) deficiencies .
METHODS	Primary outcome measures were changes in FAO , measured with stable-isotope methodology and indirect calorimetry , and changes in HR during exercise .
RESULTS	Bezafibrate lowered low-density lipoprotein , triglyceride , and free fatty acid concentrations ; however , there were no changes in palmitate oxidation , FAO , or HR during exercise .
CONCLUSIONS	Bezafibrate does not improve clinical symptoms or FAO during exercise in patients with CPT II and VLCAD deficiencies .
CONCLUSIONS	These findings indicate that previous in vitro studies suggesting a therapeutic potential for fibrates in disorders of FAO do not translate into clinically meaningful effects in vivo .
METHODS	This study provides Class I evidence that bezafibrate 200 mg 3 times daily is ineffective in improving changes in FAO and HR during exercise in adults with CPT II and VLCAD deficiencies .

###25675797
OBJECTIVE	The aim of the study was to evaluate the safety and efficacy of early feeding after cesarean delivery under different anesthetic methods .
METHODS	Two hundred women with elective cesarean delivery were randomly assigned to early oral feeding ( EOF ) or routine oral feeding ( ROF ) groups .
METHODS	EOF patients were informed that they could begin taking fluids orally ( regime I ) as soon as 2 hours after the delivery and then gradually progress to solid foods ( regime III ) , if tolerated .
METHODS	ROF patients were informed that they could start regime I right after bowel sounds were heard on examination and then gradually move on to regime III .
METHODS	Hospitalization time and total time to ambulation ( primary outcomes ) , gasstool discharge time and onset of bowel sounds ( secondary outcomes ) were compared in groups A [ EOF patients after regional anesthesia ( n = 49 ) } , B [ EOF patients after general anesthesia ( n = 48 ) } , C [ ROF patients after regional anesthesia ( n = 47 ) } and 0 [ ROF patients after general anesthesia ( n = 48 ) ] .
RESULTS	There were significant differences in primary and secondary outcomes between group A and the remaining groups , especially group D.
RESULTS	The status of patients from group B was not better than group C.
RESULTS	In fact , the latter were discharged home sooner and passage of gas , as well as initiation of regime I occurred earlier as compared to the former
CONCLUSIONS	Cesarean section under regional anesthesia and encouragement of oral feeding 2 hours after the operation should be recommended in order to acnieve postoperative recovery and early hospital discharge .
CONCLUSIONS	Routine oral feeding ( right after bowel sounds are heard on examination ) after cesarean section under general anesthesia should be the last choice .

###25352653
OBJECTIVE	Hypoglycemia is a leading risk of glucose-lowering therapy .
OBJECTIVE	Treatment with insulin glargine compared with standard care early in the course of dysglycemia in the Outcome Reduction with an Initial Glargine Intervention ( ORIGIN ) trial provides information on the frequency and predictors of hypoglycemia in this setting .
METHODS	A total of 12,537 people with high cardiovascular risk and dysglycemia treated with one or no oral glucose-lowering agents were randomized to add glargine titrated to a fasting glucose level of 5.3 mmol/L ( 95 mg/dL ) or to use standard therapies .
METHODS	Independent associations of both nonsevere hypoglycemia ( symptomatic and confirmed with a glucose level of 3 mmol/L [ 54 mg/dL ] ) and severe hypoglycemia with characteristics at baseline , treatment allocation , and average HbA1c were assessed by Cox proportional hazards models .
RESULTS	During a median follow-up period of 6.2 years , 28 % of participants reported nonsevere hypoglycemia , and 3.8 % reported severe hypoglycemia .
RESULTS	Prior use of a sulfonylurea and allocation to glargine independently predicted a higher risk for both categories of participants .
RESULTS	Nonsevere events were independently associated with younger age , lower BMI , the presence of diabetes , and higher baseline HbA1c level .
RESULTS	Severe events were associated with older age , hypertension , higher serum creatinine level , and lower cognitive function , but not baseline glycemic status .
RESULTS	Progressively higher on-treatment HbA1c level was associated with a lower risk of nonsevere events in both treatment groups ; a lower risk of severe events in the glargine group , and a higher risk of severe events with standard care .
CONCLUSIONS	Hypoglycemia was relatively uncommon in the ORIGIN trial , but was more frequent with sulfonylurea use at baseline and allocation to glargine .
CONCLUSIONS	Nonsevere and severe events were associated with different clinical characteristics , awareness of which may guide individualized therapy .

###25382751
BACKGROUND	Few studies were conducted on hepatitis B and C virus ( HBV and HCV , respectively ) risk factors among Chinese blood donors in recent years since voluntary donors replaced commercial donors .
METHODS	A case-control survey was conducted in HBV - or HCV-positive and - negative donors from five blood centers in China between September 2009 and April 2011 .
METHODS	Case status was defined by having a reactive result on Monolisa HBsAg Ultra ( Bio-Rad ) for HBV and Ortho anti-HCV EIA 3.0 ( Johnson & Johnson ) for HCV .
METHODS	Controls were randomly selected qualified blood donors matched to cases by donation month and blood center .
METHODS	Specific test-seeking , medical-related , and behavioral risk factors were compared by HBV and HCV status using chi-square tests or Fisher 's exact tests with Bonferroni correction .
RESULTS	A total of 364 HBV cases , 174 HCV cases , and 689 controls completed the survey ; response rates were 66.2 , 47.3 , and 82 % , respectively .
RESULTS	HCV-positive donors were significantly more likely to report having a blood transfusion history ( 23.4 % vs. 3.0 % , p < 0.0001 ) and ever living with a person with illegal drug injection ( 6.0 % vs. 0.5 % , p < 0.0001 ) than controls .
RESULTS	Having intravenous and intramuscular injections in the past 12 months and ever having a tattoo are marginal risk factors for HCV ( p values < 0.01 ) .
RESULTS	No specific risk factor for HBV was identified .
CONCLUSIONS	History of previous transfusion and living with illegal drug users are risk factors for HCV infection among Chinese blood donors from five regions .
CONCLUSIONS	Test-seeking behavior is not associated with HBV or HCV infections .

###25908089
BACKGROUND	Patients with a recent vertebrobasilar transient ischaemic attack or ischaemic stroke and vertebral artery stenosis of at least 50 % have a high risk of future vertebrobasilar stroke .
BACKGROUND	Stenting of vertebral artery stenosis is promising , but of uncertain benefit .
BACKGROUND	We investigated the safety and feasibility of stenting of symptomatic vertebral artery stenosis of at least 50 % , and assessed the rate of vascular events in the vertebrobasilar supply territory to inform the design of a phase 3 trial .
METHODS	Between Jan 22 , 2008 , and April 8 , 2013 , patients with a recent transient ischaemic attack or minor stroke associated with an intracranial or extracranial vertebral artery stenosis of at least 50 % were enrolled from seven hospitals in the Netherlands in a phase 2 open-label trial with masked assessment of outcome .
METHODS	Patients were randomly allocated in a 1:1 ratio to stenting plus best medical treatment or best medical treatment alone by the local investigators using a web-based randomisation system .
METHODS	The primary outcome was the composite of vascular death , myocardial infarction , or any stroke within 30 days after the start of treatment .
METHODS	The secondary outcomes were stroke in the supply territory of the symptomatic vertebral artery during follow-up , the composite outcome during follow-up , and the degree of stenosis in the symptomatic vertebral artery at 12 months .
METHODS	The trial is registered , number ISRCTN29597900 .
RESULTS	The trial was stopped after inclusion of 115 patients because of new regulatory requirements , including the use of a few prespecified stent types and external monitoring , for which no funding was available .
RESULTS	57 patients were assigned to stenting and 58 to medical treatment alone .
RESULTS	Three patients in the stenting group had vascular death , myocardial infarction , or any stroke within 30 days after the start of treatment ( 5 % , 95 % CI 0-11 ) versus one patient in the medical treatment group ( 2 % , 0-5 ) .
RESULTS	During a median follow-up of 3 years ( IQR 13-41 ) , seven ( 12 % , 95 % CI 6-24 ) patients in the stenting group and four ( 7 % , 2-17 ) in the medical treatment group had a stroke in the territory of the symptomatic vertebral artery ; 11 ( 19 % ) patients in the stenting group and ten ( 17 % ) in the medical treatment group had vascular death , myocardial infarction , or any stroke .
RESULTS	The small size of the vertebral artery and stent artifacts did not allow exact grading of restenosis on CT angiography .
RESULTS	During the complete period of follow-up , there were 60 serious adverse events ( eight strokes ) in the stenting group and 56 ( seven strokes ) in the medical treatment alone group .
CONCLUSIONS	Stenting of symptomatic vertebral artery stenosis is associated with a major periprocedural vascular complication in about one in 20 patients .
CONCLUSIONS	In the population we studied , the risk of recurrent vertebrobasilar stroke under best medical treatment alone was low , questioning the need for and feasibility of a phase 3 trial .
BACKGROUND	Dutch Heart Foundation .

###25112080
OBJECTIVE	To evaluate preliminarily the efficacy on functional constipation treated with electroacupuncture of different acupoint prescriptions .
METHODS	One hundred and four patients were randomized into a front-mu and back-shu points group ( 19 cases ) , a he-sea points group ( 34 cases ) , a he-sea , front-mu and back-shu points group ( 26 cases ) and a western medication control group ( 25 cases ) .
METHODS	In the front-mu and back-shu points group , electroacupuncture was applied at bilateral Tianshu ( ST 25 ) and Dachangshu ( BL 25 ) .
METHODS	In the he-sea points group , electroacupuncture was applied at bilateral Quchi ( LI 11 ) and Shangjuxu ( ST 37 ) .
METHODS	In the he-sea , front-mu and back-shu points group , electroacupuncture was applied at unilateral Tianshu ( ST 25 ) , Dachangshu ( BL 25 ) , Quchi ( LI 11 ) and Shangjuxu ( ST 37 ) .
METHODS	In the three groups above , the treatment was given 5 times a week in the first two weeks and 3 times a week in the next two weeks .
METHODS	In the western medication control group , mosapride citrate tablets were prescribed for oral administration , 1 table ( 5 mg ) each time , 3 times a day , continuously for 4 weeks .
METHODS	The period of research was 9 weeks , including 1 week for baseline evaluation , 4 weeks for treatment and 4 weeks for follow-up .
METHODS	The weekly defecation frequency was taken as primary index , while the defecation difficulty and life quality score were taken as the secondary indices for the efficacy evaluation after treatment and in follow-up .
RESULTS	According to the intention-to-treat ( ITT ) analytic principle , 104 cases were all enrolled in the final analysis .
RESULTS	( 1 ) After treatment , the weekly frequency of defecation was all increased significantly in the four groups ( P < 0.05 , P < 0.01 ) .
RESULTS	The efficacy of the three electroacupuncture groups was similar to that of western medication control group ( P > 0.05 ) .
RESULTS	In follow-up , the increasing effect on the weekly frequency of defecation was maintained in the he-sea points group ( P < 0.01 ) , superior to the front-mu and back-shu points group and the western medication control group ( P < 0.05 , P < 0.01 ) ; the weekly frequency of defecation was not improved in the rest three groups ( P > 0.05 ) .
RESULTS	( 2 ) After treatment , defecation difficulty was relieved in the he-sea points group , the he-sea , front-mu and back-shu points group and the western medication control group ( P < 0.05 , P < 0.01 ) .
RESULTS	In follow-up , the improvements were still significant in the he-sea points group and the he-sea , front-mu and back-shu points group ( both P < 0.01 ) .
RESULTS	( 3 ) After treatment , the life quality score was significantly improved in the patients of the he-sea points group ( P < 0.05 ) .
RESULTS	The difference was not significant in the rest three groups as compared with that before treatment ( all P > 0.05 ) .
CONCLUSIONS	The weekly frequency of defecation is increased effectively after treatment in the three electroacupuncture groups and the efficacy is similar to mosapride citrate tablets .
CONCLUSIONS	The bilateral Quchi ( LI 11 ) and Shangjuxu ( ST 37 ) in he-sea acupoints increase significantly the weekly frequency of defecation , relieve defecation difficulty and improve life quality .
CONCLUSIONS	Acupuncture efficacy is sustained for 4 weeks .
CONCLUSIONS	This acupoints prescription is the best in the treatment of functional constipation .

###24263619
BACKGROUND	Management of diabetes in elderly subjects is complex and careful management of glucose levels is of particular importance in this population because of an increased risk of diabetes-related complications and hypoglycaemia .
OBJECTIVE	The aim of this study was to evaluate the pharmacokinetic and pharmacodynamic properties of insulin degludec ( IDeg ) , a basal insulin with an ultra-long duration of action , in elderly subjects with type 1 diabetes compared with younger adults .
METHODS	This trial was a randomised , double-blind , two-period , crossover trial conducted in a single centre and included both inpatient and outpatient periods .
METHODS	Subjects were men and women aged 18-35 years inclusive ( younger adult group ) or 65 years ( elderly group ) with type 1 diabetes who received IDeg ( 0.4 U/kg ) via subcutaneous injection in the thigh once-daily for six days .
METHODS	Following 6-day dosing , a 26-hour euglycaemic glucose clamp procedure was conducted to evaluate the steady-state pharmacodynamic effects of IDeg .
METHODS	Blood samples were taken for pharmacokinetic analysis up to 120 h post-dose .
METHODS	Pharmacokinetic endpoints included the total exposure of IDeg , ie the area under the IDeg serum concentration curve during one dosing interval at steady state ( AUC ( IDeg , , SS ) ) ( = 0-24 h , equal to one dosing interval ) and the maximum IDeg serum concentration at steady state ( C ( max , IDeg , SS ) ) .
METHODS	Pharmacodynamic endpoints included the total glucose-lowering effect of IDeg , ie the area under the glucose infusion rate ( GIR ) curve at steady state ( AUC ( GIR , , SS ) ) , and the maximum GIR at steady state ( GIR ( max , IDeg , SS ) ) .
RESULTS	Total exposure ( AUC ( IDeg , , SS ) ) and maximum concentration ( C ( max , IDeg , SS ) ) of IDeg were comparable between elderly subjects and younger adults .
RESULTS	Estimated mean age group ratios ( elderly/younger adult ) for AUC ( IDeg , , SS ) and C ( max , IDeg , SS ) and corresponding two-sided 95 % confidence intervals ( CIs ) were 1.04 ( 95 % CI 0.73-1 .47 ) and 1.02 ( 95 % CI 0.74-1 .39 ) , respectively .
RESULTS	Mean AUC ( IDeg,0-12h , SS ) / AUC ( IDeg , , SS ) was 53 % in both younger adult and elderly subjects , showing that in both age groups IDeg exposure was evenly distributed across the first and second 12 h of the 24-hour dosing interval .
RESULTS	No statistically significant differences were observed between younger adult and elderly subjects with regard to AUC ( GIR , , SS ) ( the primary endpoint of this study ) and GIR ( max , IDeg , SS ) .
RESULTS	Estimated mean age group ratios ( elderly/younger adult ) for AUC ( GIR , , SS ) and GIR ( max , IDeg , SS ) and corresponding two-sided 95 % CIs were 0.78 ( 95 % CI 0.47-1 .31 ) and 0.80 ( 95 % CI 0.54-1 .17 ) , respectively .
RESULTS	Duration of action was beyond the clamp duration of 26 h in all subjects .
CONCLUSIONS	The exposure of IDeg at steady state during once-daily dosing was similar in younger adult and elderly subjects .
CONCLUSIONS	The glucose-lowering effect of IDeg was numerically lower in elderly subjects compared with younger adults , but no significant differences were observed between age groups .
CONCLUSIONS	The ultra-long pharmacokinetic and pharmacodynamic properties of IDeg observed in younger adults were preserved in elderly subjects with type 1 diabetes .
CONCLUSIONS	Clinical trials.gov number : NCT00964418 .

###24315907
OBJECTIVE	This study sought to examine the possible drug-drug interactions between clopidogrel and morphine .
BACKGROUND	Because morphine-the recommended treatment for pain of myocardial infarction-is associated with poor clinical outcome , we hypothesized that morphine lowers the plasma levels of clopidogrel active metabolite as well as its effects on platelets .
METHODS	Twenty-four healthy subjects received a loading dose of 600 mg clopidogrel together with placebo or 5 mg morphine intravenously in a randomized , double-blind , placebo-controlled , cross-over trial .
METHODS	Pharmacokinetics was determined by liquid chromatography tandem mass spectrometry , and clopidogrel effects were measured by platelet function tests .
RESULTS	Morphine injection delayed clopidogrel absorption ( p = 0.025 ) and reduced the area under the curve levels of its active metabolite by 34 % ( p = 0.001 ) .
RESULTS	Morphine delayed the maximal inhibition of platelet aggregation on average by 2 h ( n = 24 ; p < 0.001 ) .
RESULTS	Residual platelet aggregation was higher 1 to 4 h after morphine injection ( n = 24 ; p < 0.005 ) .
RESULTS	Furthermore , morphine delayed the inhibition of platelet plug formation under high shear rates ( P2Y-Innovance ; n = 21 ; p < 0.004 ) and abolished the 3-fold prolongation in collagen adenosine diphosphate-induced closure times seen in extensive and rapid metabolizers ( n = 16 ; p = 0.001 ) .
CONCLUSIONS	Morphine delays clopidogrel absorption , decreases plasma levels of clopidogrel active metabolite , and retards and diminishes its effects , which can lead to treatment failure in susceptible individuals .
CONCLUSIONS	( Drug/Drug Interactions of Aspirin and P2Y12-inhibitors ; NCT01369186 ) .

###24878030
BACKGROUND	In STEMI , grade-3 ischemia ( G3 ) on admission ECG predicts larger infarct size ( IS ) than grade-2 ( G2 ) .
BACKGROUND	We evaluated whether pre-hospital G3 and its temporal behavior are associated with IS and salvage after pPCI .
METHODS	In 401 STEMI patients , pre-hospital and pre-PCI ECGs were classified as G3 or G2 .
METHODS	IS was assessed by single-photon emission computed tomography ( SPECT ) at 30days .
METHODS	In 245 patients , pre-PCI SPECT was available to determine myocardium at risk ( MaR ) .
RESULTS	G3 criteria were met by 88 , and G2 by 313 patients .
RESULTS	G3 was independently associated with IS ( p = 0.006 ) .
RESULTS	With ST resolution ( STR ) group as a reference , G2 - > G2 , G2 - > G3 and G3 - > G3 were associated with larger IS ( B = 4.4 , p = 0.004 ; B = 5.4 , p = 0.01 ; B = 10.2 , p < 0.001 , respectively ) , whereas G3 - > G2 was not .
RESULTS	Salvage was similar between G3 and G2 on pre-hospital ECG if treated early , however lower for G3 when treated later ( > 2.5 h ) ; 48 % ( 35-78 ) vs 62 % ( 40-87 ) ; p = 0.04 .
CONCLUSIONS	Development or persistence of G3 is associated with larger IS and less salvage , but decreasing grade G3 - > G2 was not .

###24507417
BACKGROUND	The prevalence of type 2 diabetes has increased dramatically in the last decade , and is continuing to rise .
BACKGROUND	It is a chronic condition , often related to obesity , diet and sedentary lifestyles , and can lead to significant health complications , disability and early death .
BACKGROUND	Diabetes is commonly associated with depression , which can impact significantly on a person 's ability to manage their illness and , consequently , on disease outcomes .
BACKGROUND	Disease self-management is fundamental in diabetes and requires support from multiple health professionals and the active participation of the person , including in maintaining a healthy lifestyle .
BACKGROUND	The Whole Person Model was developed in order to integrate emotional and behavioural aspects into a self-management program for people with type 2 diabetes .
BACKGROUND	Here we describe a study designed to test the efficacy of the Whole Person Model of disease self-management in type 2 diabetes .
METHODS	In a parallel-group randomised trial , 180 people with type 2 diabetes of between 2-10 years duration will be recruited via invitation through the Australian National Diabetes Services Scheme .
METHODS	Participants will undergo baseline assessment , followed by randomisation to either intervention or control condition .
METHODS	Control participants will receive fact sheets containing key information about diabetes self-management .
METHODS	The intervention group will receive the INSPIRED ( Individual Support & Resources for Diabetes ) Manual and be assigned a Health Coach .
METHODS	The INSPIRED Manual consists of six modules that provide key information about diabetes and disease management using the Whole Person Model .
METHODS	Engagement is facilitated by interactive tasks and contact with a Health Coach over seven weeks -- an introductory face-to-face session , and six subsequent contacts by phone following each module .
METHODS	Follow-up assessments occur at 13 weeks ( post-intervention ) and 26 weeks .
METHODS	Primary outcomes include blood glucose management ( HbA1c ) , weight and mood .
METHODS	Secondary outcomes include level of exercise , confidence to manage diabetes , and psychosocial well-being .
CONCLUSIONS	The Whole Person Model is designed to enable health professionals to address mood disturbance without pathologizing any disorders and , in the context of the chronic illness , empowering behavior change and self-management .
CONCLUSIONS	If proven effective , this model will strengthen capacity of the healthcare workforce to foster and support effective diabetes self-management .
BACKGROUND	Australia and New Zealand Clinical Trials Register , ACTRN12613000391774 .

###25260230
BACKGROUND	Sleep disturbances are common following traumatic brain injury ( TBI ) .
BACKGROUND	The Pittsburgh Sleep Quality Index ( PSQI ) is a widely used measure of sleep quality that has been used in numerous populations .
BACKGROUND	Although this measure has been used in TBI research , there are few studies examining the psychometric properties in this population .
OBJECTIVE	The current study examined the factor structure of the PSQI in a sample of persons with TBI and tested the one , two , and three factor models derived from previous studies in other populations .
METHODS	A telephone interview was conducted with 243 individuals who had sustained a TBI .
METHODS	All participants were approximately one year post-injury .
METHODS	Factor analyses were conducted ( exploratory and confirmatory ) to examine the factor structure of the PSQI .
RESULTS	Results confirm the fit of models previously tested in the literature but also reveal an alternative conceptualization of sleep containing both qualitative and quantitative factors .
CONCLUSIONS	While the 3-factor model best fits the data in this TBI sample , the use of a 2-factor model is acceptable and may be more clinically relevant due to the grouping of time-related variables that could provide important information with regard to circadian rhythm disorders .

###24587636
OBJECTIVE	To compare the efficacy and safety of recombinant streptokinase ( rSK ) and phenylephrine-based suppositories in acute hemorrhoidal disease .
METHODS	A multicenter ( 14 sites ) , randomized ( 1:1 ) , open , parallel groups , active controlled trial was done .
METHODS	After inclusion , subjects with acute symptoms of hemorrhoids , who gave their written , informed consent to participate , were centrally randomized to receive , as outpatients , rSK ( 200000 IU ) or 0.25 % phenylephrine suppositories , which had different organoleptic characteristics .
METHODS	Treatment was administered by the rectal route , one unit every 6 h during 48 h for rSK , and up to a maximum of 5 d ( 20 suppositories ) for phenylephrine .
METHODS	Evaluations were performed at 3 , 5 and 10 d post-inclusion .
METHODS	The main end-point was the 5 ( th ) - day complete clinical response ( disappearance of pain and edema , and 70 % reduction of the lesion size ) .
METHODS	Time to response and need for thrombectomy were secondary efficacy variables .
METHODS	Adverse events were evaluated too .
RESULTS	5 ( th ) day complete response rates were 83/110 ( 75.5 % ) and 36/110 ( 32.7 % ) with rSK and phenylephrine suppositories , respectively .
RESULTS	This 42.7 % difference ( 95 % CI : 30.5-54 .2 ) was highly significant ( P < 0.001 ) .
RESULTS	The advantage was detected since the early 3 ( rd ) day evaluation ( 37.3 % vs 6.4 % for the rSK and active control groups , respectively ; P < 0.001 ) and was kept even at the late 10 ( th ) day assessment ( 83.6 % vs 58.2 % for rSK and phenylephrine , respectively ; P < 0.001 ) .
RESULTS	Time for complete response was significantly shorter ( P = 0.031 ; log-rank test ) in the rSK group ( median : 4.9 d ; 95 % CI : 4.8-5 .0 ) with respect to the active control ( median : 9.8 d ; 95 % CI : 9.8-10 .0 ) .
RESULTS	Thrombectomy was necessary in 1/59 and 8/57 patients with baseline thrombosis in the rSK and phenylephrine groups , respectively ( P = 0.016 ) .
RESULTS	There were no adverse events attributable to the experimental treatment .
CONCLUSIONS	rSK suppositories showed a significant advantage over a widely used over-the-counter phenylephrine preparation for the treatment of acute hemorrhoidal illness , with an adequate safety profile .

###25573734
BACKGROUND	The impact of different approaches to fluid management during intraoperative volume resuscitation in patients undergoing major elective surgery is poorly defined .
BACKGROUND	We compared volume effectiveness of crystalloid and colloid substitution aimed to maintain the cardiac index ( CI ) between 2.6 and 3.8 l/min/m ( 2 ) as measured by transesophageal Doppler ( TED ) .
METHODS	A total of 115 urological patients were enrolled in the prospective randomized trial and then randomized into 2 groups , one with volume therapy based on crystalloids ( n = 57 ) and the other with colloids ( n = 58 ) .
METHODS	A TED probe was inserted and then hemodynamic optimization ( therapy with Ringer 's solution or hydroxyethyl starch 6 % 130/0 .4 and administration of vasoactive drugs ) was started according to TED variables to maintain the CI between 2.6 and 3.8 l/min/m ( 2 ) .
RESULTS	We observed high incidence of CI < 2.6 l/min/m ( 2 ) after induction of anesthesia ( 75 % ) in both groups .
RESULTS	There were no significant differences in demographic characteristics , ASA classification , length of surgery , estimated blood loss and the CI during surgery .
RESULTS	To maintain the CI within the requested interval , significantly different amounts of crystalloids were needed as compared to colloid ( median : 5000 ml vs 1500 ml ) .
RESULTS	In the CRY group , more patients were treated by vasodilatators ( 40.4 vs 20.7 % ) .
CONCLUSIONS	The study confirmed that crystalloids and colloids are effective in correcting flow-related perfusion abnormalities .
CONCLUSIONS	The significant difference between volumes of crystalloids and colloids proved their different characteristics such as unequal distribution between compartments .
CONCLUSIONS	The expansion of therapeutic algorithm by using vasoactive drugs allows us to avoid adverse events resulting from fluid overload ( Tab .
CONCLUSIONS	1 , Fig. 5 , Ref .
CONCLUSIONS	35 ) .

###24249322
OBJECTIVE	Pedometry is an objective method to analyse part of physical activity .
OBJECTIVE	The aims of this study were to evaluate physical activity ( by quantifying walking steps/day ) in Romanian chronic obstructive pulmonary disease ( COPD ) patients and healthy subjects .
METHODS	A total of 58 COPD patients ( GOLD stages III and IV ) and 273 healthy subjects , divided by decades of age , wore pedometers for 2 weeks .
RESULTS	Significant decrease of physical activity level was observed in COPD patients vs. control group ( 3,4141,105 vs. 7,2002,452 steps/day ) .
RESULTS	Walking performance of patients with COPD stage III was better than that of patients with COPD stage IV .
RESULTS	For both groups , the lowest activity level was recorded during the weekend .
RESULTS	Patients with COPD could not perform any aerobic movement .
CONCLUSIONS	This study revealed a difference of physical activity in both healthy individuals and COPD patients , in the latter group the decrease being worse and in accordance with the disease severity .

###25441765
BACKGROUND	The potential of secretory leukocyte protease inhibitor ( SLPI ) as a biomarker for colorectal cancer was studied .
BACKGROUND	A prospective , randomized , controlled , clinical trial was conducted in 2013 and 2014 to confirm whether the expression of SLPI correlates with prognosis and metastasis in colorectal cancer patients .
METHODS	Immunohistochemistry was used to detect SLPI expression in colorectal cancer .
METHODS	The expression of SLPI was scored by two pathologists independently .
METHODS	Statistical analysis of the data was performed using a 2 test to investigate the influence of SLPI on the pathologic characteristics of colorectal cancer .
RESULTS	Compared with normal tissue , SLPI was overexpressed in colorectal cancer tissue .
RESULTS	Overexpression of SLPI correlated with different grades ( moderate or good differentiation : 2.7 % low expression versus 97.3 % high expression , low differentiation : 41.7 % low expression versus 58.3 % high expression ) , TNM stage ( I or II : 4.2 % low expression versus 95.8 % high expression ; III or IV : 19.7 % low expression versus 80.3 % high expression ) , lymphatic metastasis ( 18.6 % low expression versus 81.4 % high expression ) and distal metastasis ( 86.5 % low expression versus 13.5 % high expression ) , but not with patient age or sex ( P = 0.613 , P = 0.871 ) .
CONCLUSIONS	Upregulated SLPI correlates with aggressive pathologic characteristics of colorectal cancer ; SLPI could be used as an indicator of progression and metastasis in patients with colorectal cancer .

###25028983
OBJECTIVE	The purpose of this study was to investigate the impact of recovery by cool or warm water immersion , between two 50-m sprints on performance determinants and lactate responses in simulated competition conditions .
METHODS	Eight well-trained sprint swimmers ( 21 2.4 years ) , after an initial warm-up and 15-minutes recovery with no immersion ( NI ) , performed a maximal 50 m sprint .
METHODS	A second 50 m sprint followed after a second 15-minute recovery period with passive immersion in either warm ( WI , 30 C ) , or cool water ( CI , 26.7 C ) .
METHODS	In a crossover design , all subjects repeated the trial 48 hours later utilizing the alternate immersion temperature .
METHODS	During the 50-m sprints , time and stroke characteristics were recorded .
METHODS	Blood lactate and heart rates were measured before and after the trials .
METHODS	Strength and flexibility were recorded before and after immersions and ratings of perceived exertion were evaluated .
RESULTS	There were no significant differences in time , event velocity , or stroke rate , between any of the trials .
RESULTS	With WI , a significant reduction of handgrip strength was observed ( P = 0.029 ) with lower ratings of perceived exertion observed after the sprint .
RESULTS	Higher resting lactate levels were recorded , prior to swimming , after both the 15-minute WI and CI water recoveries ( P < 0.01 ) as compared to NI .
RESULTS	No correlation was observed between swim performance times and starting or peak lactate levels , with any type of recovery intervention ( R2 = 0.047 ; slope NS from zero ) .
CONCLUSIONS	Recovery by cool ( 26.7 C ) or warm ( 30 C ) water immersion does not affect velocity or stroke characteristics in a 50-m freestyle sprint , even when widely employed performance related determinants such as resting lactate levels and perceived exertion are not optimal .

###24842596
BACKGROUND	Message framing outcomes of healthy behaviours as occurring ` every day ' vs. ` every year ' can influence the temporal proximity and perceived likelihood of these outcomes .
BACKGROUND	However , it is not known how pre-existing beliefs such as confidence in one 's ability to perform health-related behaviour interact with such messages .
OBJECTIVE	The purpose of this research was to investigate whether eating self-efficacy moderates the effect of temporal framing ( day-frame vs. year-frame ) on snacking behaviour .
METHODS	Participants ( N = 95 ) completed the short form of the Weight Efficacy Lifestyle Questionnaire ( WEL-SF ) and read either a day-framed or year-framed message about the health benefits associated with avoiding snacking .
METHODS	Consumption of snacks was reported 7 days later .
RESULTS	For those with low levels of eating self-efficacy ( WEL-SF score < 4.3 on a 7-point response scale ) , the year-framed message was associated with lower levels of snacking than the day-framed message .
CONCLUSIONS	The current research identifies a key role for eating self-efficacy in shaping recipients ' responses to temporally framed messages about the health benefits associated with the avoidance of snacking .

###25007368
BACKGROUND	Interdigital tinea pedis is one of the most common clinical presentations of dermatophytosis .
OBJECTIVE	This phase 3 study evaluated the safety and efficacy of luliconazole cream 1 % in patients with tinea pedis .
METHODS	A total of 321 male and female patients aged 12 years with tinea pedis and eligible for modified intent-to-treat analysis were randomized 1:1 to receive luliconazole cream 1 % ( n = 159 ) or vehicle ( n = 162 ) once daily for 14 days .
METHODS	Efficacy was evaluated at days 28 and 42 ( i.e. , days 14 and 28 posttreatment ) based on clinical signs ( erythema , scaling , pruritus ) and mycology ( KOH , fungal culture ) .
METHODS	The primary outcome was complete clearance at day 42 .
METHODS	Safety evaluations included adverse events and laboratory assessments .
RESULTS	Complete clearance at day 42 was achieved in 26.4 % ( 28/106 ) of patients treated with luliconazole cream 1 % compared with 1.9 % ( 2/103 ) of patients treated with vehicle ( P < 0.001 ) .
RESULTS	Similar safety profiles were obtained for luliconazole cream 1 % and vehicle .
CONCLUSIONS	This study was conducted in a relatively small population under controlled clinical trial conditions .
CONCLUSIONS	Luliconazole cream 1 % applied once daily for 14 days is well tolerated and more effective than vehicle in patients with tinea pedis .

###24887013
BACKGROUND	Small dense low density lipoprotein-cholesterol ( sdLDL-C ) molecules are more atherogenic compared with large buoyant ones .
BACKGROUND	Phytosterols-enriched diets are effective in decreasing total cholesterol ( TC ) and low density lipoprotein-cholesterol ( LDL-C ) concentrations in hyperlipidemic children without significant adverse effects .
BACKGROUND	Limited data on the impact of such a diet on sdLDL-C levels is available in adults while there are no reports concerning children .
BACKGROUND	The purpose of this study is to prospectively evaluate the effect of the daily consumption of 2 g of plant sterols on sdLDL-C levels in children with hypercholesterolemia .
METHODS	Fifty-nine children , 25 with LDL-C 3.4 mmol/l ( 130 mg/dl ) and 34 with LDL-C < 3.4 mmol/l , aged 4.5-15 .9 years , were included in the study .
METHODS	A yogurt-drink enriched with 2 g of plant sterols was added to the daily diet of hypercholesterolemic children and 6-12 months later lipid profiles were reassessed .
METHODS	Direct quantitative methods were used to measure LDL-C and sdLDL-C levels .
RESULTS	The consumption of plant sterols reduced sdLDL-C significantly ( p < 0.001 ) , but levels remained higher compared with controls ( p < 0.001 ) .
RESULTS	TC , LDL-C , non high density lipoprotein-cholesterol ( NonHDL-C ) and apolipoprotein B ( ApoB ) levels also decreased significantly ( p < 0.05 ) .
RESULTS	The median reduction of sdLDL-C and LDL-C was 16.6 % and 13 % , respectively .
RESULTS	These variables decreased > 10 % in sixteen children ( 64 % ) , independently from baseline levels , sex , age and body mass index ( BMI ) .
RESULTS	High density lipoprotein-cholesterol ( HDL-C ) , lipoprotein a [ Lp ( a ) ] , and triglycerides ( TGs ) levels remained unaffected .
CONCLUSIONS	Plant sterols decrease sdLDL-C significantly and may be beneficial for children with hypercholesterolemia .

###24619016
OBJECTIVE	Acute bowel toxicity significantly affects the quality of life of patients treated with pelvic radiotherapy .
OBJECTIVE	This study was performed to assess whether pretreatment with famotidine can reduce acute radiation toxicities in patients undergoing radiotherapy for prostate cancer .
METHODS	Between April 2012 and February 2013 , 36 patients undergoing radiotherapy for prostate cancer were enrolled to receive either placebo or famotidine .
METHODS	The patients received external-beam radiotherapy up to 70 Gy at daily fractions of 1.8-2 Gy ( 5 days/week ) .
METHODS	Oral famotidine 40 mg ( 80 mg/day ) or placebo was administered twice daily ( 4 and 3 h prior to each radiotherapy fraction ) .
METHODS	Bowel and bladder acute toxicities were evaluated weekly during radiotherapy and once thereafter according to RTOG grading criteria .
RESULTS	Famotidine was well tolerated .
RESULTS	No grade III or higher acute toxicities were noted in the two groups .
RESULTS	Grade II rectal toxicity developed significantly more often in patients receiving placebo than in patients receiving famotidine ( 10/18 vs. 2/16 , p = 0.009 ) .
RESULTS	Moreover , no rectal bleeding occurred in the famotidine group , while 5 patients in the placebo group experienced rectal bleeding during treatment ( p = 0.046 ) .
RESULTS	The duration of rectal toxicity in the radiotherapy course was also reduced in the famotidine group ( 15.7 vs. 25.2 days , p = 0.027 ) .
RESULTS	No significant difference between the two groups was observed in terms of urinary toxicity .
CONCLUSIONS	We demonstrated for the first time that famotidine significantly reduces radiation-induced injury on rectal mucosa representing a suitable radioprotector for patients treated with radiotherapy for prostate cancer .

###24326811
OBJECTIVE	The aim of this study was to comparatively evaluate in vivo the disinfecting ability of conventional method and lasers in root canals .
METHODS	Study criteria included 60 single rooted teeth , which were indicated for root canal therapy followed to dental caries and trauma with intact crowns .
METHODS	Such selected patients were randomly divided into 2 groups , namely , Group A ( 30 teeth ) and Group B ( 30 teeth ) .
METHODS	All clinical procedures were carried out under strict aseptic precautions .
METHODS	The teeth in Group A were subjected to biomechanical preparation followed by the treatment with the help of diode laser containing the gallium aluminum and arsenic , which emitted 980 nm wavelengths .
METHODS	The teeth in Group B were treated with routine method of biomechanical preparation along with irrigation using sodium hypochlorite and hydrogen peroxide .
METHODS	The microbiological samples were taken immediately after the access preparation and after the completion of the root canal disinfection and were sent for microbiological analysis .
RESULTS	The teeth in Group A showed presence of common strains of bacteria ranging from Streptococci , Staphylococci , Klebsiella , and Pseudomonas .
RESULTS	Reduction in the growth of microorganisms was found for all types of microorganisms .
RESULTS	Only 8 samples exhibited the growth after treatment with laser .
RESULTS	Results of Group B also showed the presence of common strains of anaerobic and aerobic bacteria as shown in earlier studies , predominantly Staphylococcus , Streptococci , and Pseudomonas .
RESULTS	Statistical analysis showed non-significant P values for the microorganisms ; however , only 3 samples showed the growth after treatment with conventional technique using sodium hypochlorite and hydrogen peroxide .
CONCLUSIONS	Conventional method by using sodium hypochlorite and hydrogen peroxide as irrigating solutions is highly effective in disinfecting the root canal .
CONCLUSIONS	Lasers when used can also reduce the bacterial load of the infected root canal .

###25574984
BACKGROUND	Combination therapy with two or more different drugs , with the intension of reaching the same therapeutic goal , was heavily criticized for a long time .
BACKGROUND	However , it is accepted today , especially when advantage over monotherapy can be proved .
BACKGROUND	Our study was undertaken to compare whether propofol priming and midazolam predosing would affect total induction dose requirement of Propofol .
METHODS	A prospective randomized , double blind control study was conducted where 120 patients ( 16-65 years ) were divided into 3 groups .
METHODS	Group P received 0.4 mg/kg of Propofol , Group M received 0.05 mg/kg of Midazolam and Group N received 3 ml of Normal Saline 5 minutes after intravenous pethidine 0.75 mg / kg given for analgesia .
METHODS	We compared the total dose of propofol requirement for induction of anaesthesia in all the 3 groups , taking loss of verbal contact as the end point .
METHODS	Additionally , changes in haemodynamic status like blood pressure and heart rate at various intervals were studied and compared among the groups .
RESULTS	The groups were similar in terms of age , sex , weight and American Society of Anesesthesiologists Physical Status.The dose of Propofol required to induce anesthesia in Midazolam group was 1.58 mg/kg ,1.86 mg/kg in Propofol group and 1.96 mg/kg in the control group .
RESULTS	There were less hemodynamic changes in Midazolam group compared to the other two .
CONCLUSIONS	Pre-dosing with Midazolam is more effective than Propofol priming in reducing the dose of Propofol induced anaesthesia associated with minimum hemodynamic alterations .

###24803435
BACKGROUND	Most drug-eluting stents currently in use are coated with a polymer carrying the drug that is released for several weeks .
BACKGROUND	However , a durable polymer may provoke hypersensitive reaction , delayed artery healing , and eventually stent thrombosis .
BACKGROUND	The aim of this study was to investigate the safety and efficacy of a polymer-free paclitaxel-eluting stent ( PF-PES ) versus a polymer-based PES ( PB-PES ) .
RESULTS	Eligible patients undergoing percutaneous coronary intervention were randomized 1:1 to receive either PF-PES or PB-PES .
RESULTS	The primary end point was late loss at 9 months .
RESULTS	Intravascular ultrasound analysis at 9 months and final 2-year clinical follow-up were also performed .
RESULTS	From October 2007 to April 2009 , 164 patients were enrolled and randomized into 2 groups ( PF-PES : n = 84 ; PB-PES : n = 80 ) .
RESULTS	Mean in-stent lumen loss was 0.90 0.59 mm for PF-PES and 0.49 0.52 mm for PB-PES ( P < 0.001 ) .
RESULTS	Mean neointimal area by intravascular ultrasound was higher in PF-PES than in PB-PES ( 1.42 1.09 versus 0.51 0.61 mm ( 2 ) ; P < 0.001 ) .
RESULTS	At 2 years , a composite end point of all-cause death , any myocardial infarction , and target vessel revascularization occurred in 36.9 % for PF-PES and 16.3 % for PB-PES ( P = 0.004 ) , mainly driven by a higher rate of target vessel revascularization ( PF-PES : 35.7 % ; PB-PES : 13.8 % ; P = 0.001 ) .
RESULTS	One late stent thrombosis was observed in PF-PES .
CONCLUSIONS	Compared with PB-PES , PF-PES was associated with increased neointimal proliferation and subsequent clinical restenosis .
CONCLUSIONS	Polymer plays an essential role in the performance of drug-eluting stents .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01375855 .

###25144794
BACKGROUND	Response to treatment may be useful for diagnostic confirmation of childhood tuberculosis ( TB ) .
BACKGROUND	We aimed to evaluate time to symptom resolution in children treated for pulmonary TB .
METHODS	We compared pulmonary TB cases and noncases , classified by a published diagnostic algorithm , in South African children younger than 2 .
METHODS	TB treatment was prescribed independently on clinical grounds .
METHODS	We analyzed independent determinants of baseline symptom resolution by Cox regression .
RESULTS	One hundred and ninety-one symptomatic children , median age 12 months , were prescribed for TB treatment .
RESULTS	Chest radiograph features of TB were associated with longer time to resolution of cough ( adjusted hazard ratio , AHR 0.31 ) , wheeze ( AHR 0.26 ) and failure to thrive ( AHR 0.41 ) , ( all P < 0.05 ) .
RESULTS	However , median duration of baseline cough ( 63 vs. 70 days , P = 0.98 ) , wheeze ( 62 vs. 68 days , P = 0.87 ) and failure to thrive ( 76 vs. 66 days , P = 0.59 ) did not differ in TB cases ( n = 48 ) versus noncases ( n = 46 ) .
CONCLUSIONS	Baseline symptoms take more than 60 days to resolve in the majority of young children after starting TB treatment .
CONCLUSIONS	Furthermore , since time to resolution does not differentiate TB cases from noncases ; clinical response to treatment is not an appropriate diagnostic criterion for pediatric trials of TB diagnostics , drugs and vaccines .

###24332420
OBJECTIVE	This study sought to assess device-specific outcomes after implantation of bare-metal stents ( BMS ) , zotarolimus-eluting Endeavor Sprint stents ( ZES-S ) , paclitaxel-eluting stents ( PES ) , or everolimus-eluting stents ( EES ) ( Medtronic Cardiovascular , Santa Rosa , California ) in all-comer patients undergoing percutaneous coronary intervention .
BACKGROUND	Few studies have directly compared second-generation drug-eluting stents with each other or with BMS .
METHODS	We randomized 2,013 patients to BMS , ZES-S , PES , or EES implantation .
METHODS	At 30 days , each stent group received up to 6 or 24 months of clopidogrel therapy .
METHODS	The key efficacy endpoint was the 2-year major adverse cardiac event ( MACE ) including any death , myocardial infarction , or target vessel revascularization , whereas the cumulative rate of definite or probable stent thrombosis ( ST ) was the key safety endpoint .
RESULTS	Clinical follow-up at 2 years was complete for 99.7 % of patients .
RESULTS	The MACE rate was lowest in EES ( 19.2 % ; 95 % confidence interval [ CI ] : 16.0 to 22.8 ) , highest in BMS ( 32.1 % ; 95 % CI : 28.1 to 36.3 ) , and intermediate in PES ( 26.2 % ; 95 % CI : 22.5 to 30.2 ) and ZES-S ( 27.8 % ; 95 % CI : 24.1 to 31.9 ) groups ( chi-square test = 18.9 , p = 0.00029 ) .
RESULTS	The 2-year incidence of ST in the EES group ( 1 % ; 95 % CI : 0.4 to 2.2 ) was similar to that in the ZES-S group ( 1.4 % ; 95 % CI : 0.7 to 2.8 ) , whereas it was lower compared with the PES ( 4.6 % , 95 % CI : 3.1 to 6.8 ) and BMS ( 3.6 % ; 95 % CI : 2.4 to 5.6 ) groups ( chi-square = 16.9 ; p = 0.0001 ) .
CONCLUSIONS	Our study shows that cumulative MACE rate , encompassing both safety and efficacy endpoints , was lowest for EES , highest for BMS , and intermediate for PES and ZES-S groups .
CONCLUSIONS	EES outperformed BMS also with respect to the safety endpoints with regard to definite or probable and definite , probable , or possible ST. ( PROlonging Dual antiplatelet treatment after Grading stent-induced Intimal hyperplasia studY [ PRODIGY ] ; NCT00611286 ) .

###24709242
OBJECTIVE	To determine the efficacy of Rifaximin in prevention of repeated episodes of hepatic encephalopathy in patients with liver cirrhosis as compared to placebo .
METHODS	Triple-blind , randomized placebo-controlled trial .
METHODS	Department of Gastroenterology-Hepatology , Shaikh Zayed Hospital , Lahore , from October 2012 to April 2013 .
METHODS	Patients in remission from recurrent hepatic encephalopathy resulting from cirrhosis were randomly assigned to receive either Rifaximin , at a dose of 550 mg twice daily ( 63 patients ) , or placebo ( 63 patients . )
METHODS	Patients were requested to take the drug orally twice daily for 6 months or until they developed a breakthrough episode of hepatic encephalopathy .
RESULTS	Mean age of patients in treatment and control group was 40.21 2.33 years and 42.87 4.54 years respectively .
RESULTS	The most common etiology of cirrhosis was hepatitis C followed by hepatitis B. Patients who remained free of hepatic encephalopathy during study period were 40 out of 63 patients in control group and 35 patients out of 63 patients ( p = 0.56 ) .
RESULTS	Most of the patients who developed breakthrough hepatic encephalopathy had a MELD score range of 21-25 in both groups .
RESULTS	The number of deaths and adverse events was similar in both groups .
CONCLUSIONS	Over a 6-month period , treatment with Rifaximin failed to maintain remission from hepatic encephalopathy more effectively than placebo in the studied group .

###24890878
BACKGROUND	Novel sensory inputs for the control of food intake and gastrointestinal ( GI ) function are of increasing interest due to the rapid increase in nutrition-related diseases .
BACKGROUND	The essential amino acid L-lysine was demonstrated to have a selective impact on food intake , gastric emptying , and intestinal transit in rats , thus indicating a potential novel direct sensory input to assess dietary protein content and quality .
BACKGROUND	The aim of this study was to assess translational aspects of this finding and to investigate the dose-dependent effect of L-lysine on human and rat GI function .
METHODS	L-lysine doses from 0-800 mg in rats and 0.5-7 .5 g in humans were analyzed for their effect on gastric emptying and GI secretion .
METHODS	Human GI function was assessed non-invasively using magnetic resonance imaging ( MRI ) , rat data were acquired using standard lethal measurement methods .
METHODS	L-lysine dose dependently delayed gastric emptying and stimulated GI secretion in rats as reflected by residual phenol red content and increased gastric wet weight .
RESULTS	The dose-dependent delay in gastric emptying observed in rats was confirmed in humans with an increase in halftime of gastric emptying of 4 min/g L-lysine , p < 0.01 .
RESULTS	Moreover , a dose-dependent increase in intestinal fluid accumulation was observed ( 0.4 mL/min/g L-lysine , p < 0.0001 ) .
RESULTS	No effect on alkaline tide , glucose concentration , hematocrit , or visceral sensations was detected .
CONCLUSIONS	This translational study demonstrates comparable dose-dependent effects of intragastric L-lysine on GI function in humans and rats and suggests a broader role for individual amino acids in the control of GI motility and secretion in vivo .

###25076468
OBJECTIVE	To assess and compare the effects of contact lens-based artificial pupil design and contralateral balanced multifocal contact lens combination ( CBMCLC ) on visual performance .
METHODS	This randomized crossover study conducted at the University of Valencia , Spain included 38 presbyopic patients using an artificial pupil contact lens in the nondominant eye and a CBMCLC .
METHODS	After a month of lens wear , the binocular distance visual acuity ( BDVA ) , binocular near visual acuity ( BNVA ) , defocus curve , binocular distance , and near contrast sensitivity and near stereoacuity ( NSA ) were measured under photopic conditions ( 85 cd/m2 ) .
METHODS	Moreover , BDVA and binocular distance contrast sensitivity were examined under mesopic conditions ( 5 cd/m2 ) .
RESULTS	Visual acuity at an intermediate distance and near vision was better with the CBMCLC than with the artificial pupil ( p < 0.05 ) .
RESULTS	Statistically significant differences were found in contrast sensitivity between the two types of correction for distance ( under mesopic conditions ) and for near vision , with the CBMCLC exhibiting better results in both cases ( p < 0.05 ) .
RESULTS	The mean NSA values obtained for the artificial pupil contact lens were significantly worse than those for the CBMCLC ( p = 0.001 ) .
CONCLUSIONS	The CBMCLC provided greater visual performance in terms of intermediate and near vision compared with the artificial pupil contact lens .

###26062186
OBJECTIVE	To verify the clinical efficacy of acupuncture and moxibustion on depressive states of stroke patients ' spouses .
METHODS	Forty-four subjects who were stroke patients ' spouses and according with inclusive criteria with mild or moderate depressive states were randomly divided into an acupuncture-moxibustion group and a blank control group , 22 cases in each group .
METHODS	In the acupuncture-moxibustion group , acupuncture was applied at Baihui ( GV 20 ) , Shenting ( GV 24 ) , Sishencong ( EX-HN 1 ) , Hegu ( LI 4 ) , Zusanli ( ST 36 ) and Taichong ( LR 3 ) , and suspended moxibustion was used at Shenque ( CV 8 ) , Guanyuan ( CV 4 ) and Zhongwan ( CV 12 ) .
METHODS	The treatment was given twice a week for continuous 8 weeks .
METHODS	In the blank control group , neither acupuncture nor moxibustion treatment was given , and the patients were only treated with health and psychological guidance .
METHODS	Before treatment and after 8-week treatment , scores of self-rating depression scale ( SDS ) and numbers of insomnia severity grade were observed .
RESULTS	In the two groups , the scores of SDS were both reduced than those before treatment ( both P < 0.05 ) , and the decrease in the acupuncture-moxibustion group was more obvious ( P < 0.05 ) .
RESULTS	After treatment , the number of insomnia severity grade in the acupuncture-moxibustion group was improved than that before treatment ( P < 0.001 ) , and the improvement was evidently superior to that in the blank control group ( P < 0.05 ) .
RESULTS	The numbers of insomnia severity grade of the blank control group before and after treatment had no statistic significance ( P > 0.05 ) .
CONCLUSIONS	The acupuncture and moxibustion intervention plan has clinical treatment significance on the improvement of mild and moderate depressive states for the stroke patients ' primary caregivers who are the patients ' spouses .

###24719064
BACKGROUND	Melasma has a negative impact on quality of life since it typically occurs on the face .
OBJECTIVE	To evaluate the erythema and pigmentation of melasma lesions and the surrounding areas in patients receiving triple combination ( TC : hydroquinone , tretinoin , and fluocinolone acetonide ) regimens .
METHODS	Patients first received an 8-week daily TC treatment and were then randomized to twice weekly or tapering regimen with TC .
METHODS	Melanin and erythema levels of lesions and surrounding areas were objectively measured using a narrowband reflectance spectrophotometer .
RESULTS	Progressive reduction in the mean melanin levels was observed in the treatment phase .
RESULTS	Following both maintenance regimens , there was no difference between melanin levels in the melasma lesions .
RESULTS	Adverse effects were rare in both phases of the study and there was borderline reduction in erythema with regimen II .
CONCLUSIONS	Both maintenance regimens were effective in maintaining results obtained during the initial treatment phase , and were safe and well-tolerated .
CONCLUSIONS	Erythema was less intense with the tapering regimen .

###24825029
OBJECTIVE	We compared the longer-term impact of the two most commonly applied forms of post-discharge management designed to minimize recurrent hospitalization and prolong survival in typically older patients with chronic heart failure ( CHF ) .
METHODS	We followed a multi-center randomized controlled trial cohort of Australian patients hospitalized with CHF and initially allocated to home-based or specialized CHF clinic-based intervention for 1368 216 days .
METHODS	Blinded endpoints included event-free survival from all-cause emergency hospitalization or death , all-cause mortality and rate of all-cause hospitalization and stay .
RESULTS	280 patients ( 73 % male , aged 71 14 years and 73 % left ventricular systolic dysfunction ) were initially randomized to home-based ( n = 143 ) or clinic-based ( n = 137 ) intervention .
RESULTS	During extended follow-up ( complete for 274 patients ) , 1139 all-cause hospitalizations ( 7477 days of hospital stay ) and 121 ( 43.2 % ) deaths occurred .
RESULTS	There was no difference in the primary endpoint ; 20 ( 14.0 % ) home-based versus 13 ( 7.4 % ) clinic-based patients remained event-free ( adjusted HR 0.89 , 95 % CI 0.70 to 1.15 ; p = 0.378 ) .
RESULTS	Significantly fewer home-based ( 51/143 , 35.7 % ) than clinic-based intervention ( 71/137 , 51.8 % ) patients died ( adjusted HR 0.62 , 95 % CI 0.42 to 0.90 : p = 0.012 ) .
RESULTS	Home-based versus clinic-based intervention patients accumulated 592 and 547 all-cause hospitalizations ( p = 0.087 ) associated with 3067 ( median 4.0 , IQR 2.0 to 6.8 ) versus 4410 ( 6.0 , IQR 3.0 to 12.0 ) days of hospital stay ( p < 0.01 for rate and duration of hospital stay ) .
CONCLUSIONS	Relative to clinic-based intervention , home-based intervention was not associated with prolonged event-free survival .
CONCLUSIONS	Home-based intervention was , however , associated with significantly fewer all-cause deaths and significantly fewer days of hospital stay in the longer-term .
BACKGROUND	Australian New Zealand Clinical Trials Registry number 12607000069459 ( http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=81803 ) .

###25842580
OBJECTIVE	To investigate the contribution of Bispectralindex monitoring on the amount of used anaesthetic substance and the quality of anaesthesia in patients with persistent atrial fibrillation who would undergo cardioversion .
METHODS	The prospective , randomised , controlled clinical study was conducted at Akdeniz University , Antalya , Turkey from October 2010 to November 2011 Sedation was performed on 50 adult patients using midazolam and fentanyl .
METHODS	Patients were randomised to group 1 and 2 .
METHODS	In group 1 cardioversion was performed when the BispectralIndex value was seen to have decreased to < 80 and the Ramsay sedation score was 5-6 .
METHODS	In Group 2 , BispectralIndex monitor was blinded to the investigator , and cardioversion was performed when Ramsay sedation score was 5-6 .
METHODS	In both groups , blood pressure , heart rate and Bispectral index values were recorded .
METHODS	Total anaesthetic amount , awareness and pain were also assessed .
METHODS	SPSS 13 was used for statistical analysis .
RESULTS	Overall , 23 ( 46 % ) patients were male and 27 ( 54 % ) were female and there was no significant difference in the two groups in terms of age ( p > 0.05 ) .
RESULTS	No statistically significant difference was detected between the groups in terms of induction time , anaesthetic need and Bispectral Index values ( p > 0.05 ) .
RESULTS	In both groups , 2 ( 8 % ) patients perceived pain and 2 ( 8 % ) perceived the procedure .
CONCLUSIONS	In the presence of anaesthetist in the team , Bispectral Index monitoring did not contribute to the determining of anaesthetic drug dosage and the depth and quality of anaesthesia in patients with persistent atrial fibrillation during cardioversion .

###24974817
OBJECTIVE	To determine whether genotypes at 2 major loci associated with late age-related macular degeneration ( AMD ) , complement factor H ( CFH ) and age-related maculopathy susceptibility 2 ( ARMS2 ) , influence the relative benefits of Age-Related Eye Disease Study ( AREDS ) supplements .
METHODS	Unplanned retrospective evaluation of a prospective , randomized , placebo-controlled clinical trial of vitamins and minerals for the treatment of AMD .
METHODS	AREDS participants ( mean age , 69 years ) who were at risk of developing late AMD and who were randomized to the 4 arms of AREDS supplement treatment .
METHODS	Analyses were performed using the Cox proportional hazards model to predict progression to late AMD ( neovascular or central geographic atrophy ) .
METHODS	Statistical models , adjusted for age , gender , smoking status , and baseline AMD severity , were used to examine the influence of genotypes on the response to therapy with 4 randomly assigned arms of AREDS supplement components : placebo , antioxidants ( vitamin C , vitamin E , - carotene ) , zinc , or a combination .
METHODS	The influence of the genotype on the relative treatment response to the randomized components of the AREDS supplement , measured as progression to late AMD .
RESULTS	Of the 1237 genotyped AREDS participants of white ethnicity , late AMD developed in 385 ( 31.1 % ) during the mean follow-up of 6.6 years .
RESULTS	As previously demonstrated , CFH genotype ( P = 0.005 ) , ARMS2 ( P < 0.0001 ) , and supplement were associated individually with progression to late AMD .
RESULTS	An interaction analysis found no evidence that the relative benefits of AREDS supplementation varied by genotype .
RESULTS	Analysis of ( 1 ) CFH rs1061170 and rs1410996 combined with ARMS2 rs10490924 with the 4 randomly assigned arms of AREDS supplement and ( 2 ) analysis of the combination of CFH rs412852 and rs3766405 with ARMS2 c. 372_815del443ins54 with the AREDS components resulted in no interaction ( P = 0.06 and P = 0.45 , respectively , before multiplicity adjustment ) .
CONCLUSIONS	The AREDS supplements reduced the rate of AMD progression across all genotype groups .
CONCLUSIONS	Furthermore , the genotypes at the CFH and ARMS2 loci did not statistically significantly alter the benefits of AREDS supplements .
CONCLUSIONS	Genetic testing remains a valuable research tool , but these analyses suggest it provides no benefits in managing nutritional supplementation for patients at risk of late AMD .

###24622685
OBJECTIVE	To analyze performance and fatigue effects of small-sided games ( SSG ) vs high-intensity interval training ( HIIT ) performed during a 4-wk in-season period in high-level youth football .
METHODS	Nineteen players from 4 youth teams ( 16.5 [ SD 0.8 ] y , 1.79 [ 0.06 ] m , 70.7 [ 5.6 ] kg ) of the 2 highest German divisions completed the study .
METHODS	Teams were randomly assigned to 1 of 2 training sequences ( 2 endurance sessions per wk ) : One training group started with SSG , whereas the other group conducted HIIT during the first half of the competitive season .
METHODS	After the winter break , training programs were changed between groups .
METHODS	Before and after the training periods the following tests were completed : the Recovery-Stress Questionnaire for Athletes , creatine kinase and urea concentrations , vertical-jump height ( countermovement jump [ CMJ ] , drop jump ) , straight sprint , agility , and an incremental field test to determine individual anaerobic threshold ( IAT ) .
RESULTS	Significant time effects were observed for IAT ( +1.3 % , ( p ) ( 2 ) = .31 ) , peak heart rate ( -1.8 % , ( p ) ( 2 ) = .45 ) , and CMJ ( -2.3 % , ( p ) ( 2 ) = .27 ) , with no significant interaction between groups ( P > .30 ) .
RESULTS	Players with low baseline IAT values ( +4.3 % ) showed greater improvements than those with high initial values ( 0.0 % ) .
RESULTS	A significant decrease was found for total recovery ( -5.0 % , ( p ) ( 2 ) = .29 ) , and an increase was found for urea concentration ( +9.2 % , ( p ) ( 2 ) = .44 ) .
CONCLUSIONS	Four weeks of in-season endurance training can lead to relevant improvements in endurance capacity .
CONCLUSIONS	The decreases in CMJ height and total-recovery score together with the increase in urea concentration might be interpreted as early signs of fatigue .
CONCLUSIONS	Thus , the danger of overtaxing players should be considered .

###25083559
OBJECTIVE	To evaluate the effects of whole body vibration ( WBV ) and local muscle vibration ( LMV ) on quadriceps function after experimental knee effusion ( ie , simulated pathology ) .
METHODS	Randomized controlled trial .
METHODS	Research laboratory .
METHODS	Healthy volunteers ( N = 43 ) were randomized to WBV ( n = 14 ) , LMV ( n = 16 ) , or control ( n = 13 ) groups .
METHODS	Saline was injected into the knee to induce quadriceps arthrogenic muscle inhibition ( AMI ) .
METHODS	All groups then performed isometric squats while being exposed to WBV , LMV , or no vibration ( control ) .
METHODS	Quadriceps function was assessed at baseline , immediately after effusion , and immediately and 5 minutes after each intervention ( WBV , LMV , control ) via voluntary peak torque ( VPT ) and the central activation ratio ( CAR ) during maximal isometric knee extension on a multifunction dynamometer .
RESULTS	The CAR improved in the WBV ( 11.4 % , P = .021 ) and LMV ( 7.3 % , P < .001 ) groups immediately postintervention , but they did not improve in the control group .
RESULTS	Similarly , VPT increased by 16.5 % ( P = .021 ) in the WBV group and 23 % ( P = .078 ) in the LMV group immediately postintervention , but it did not increase in the control group .
RESULTS	The magnitudes of improvements in the CAR and VPT did not differ between the WBV and LMV groups .
CONCLUSIONS	Quadriceps AMI is a common complication following knee pathology that produces quadriceps dysfunction and increases the risk of posttraumatic osteoarthritis .
CONCLUSIONS	Quadriceps strengthening after knee pathology is often ineffective because of AMI .
CONCLUSIONS	WBV and LMV improve quadriceps function equivocally after simulated knee pathology , effectively minimizing quadriceps AMI .
CONCLUSIONS	Therefore , these stimuli may be used to enhance quadriceps strengthening , therefore improving the efficacy of rehabilitation and reducing the risk of osteoarthritis .

###24447460
BACKGROUND	Cognitive behaviour therapy ( CBT ) is an effective treatment for depression .
BACKGROUND	However , CBT is a complex therapy that requires highly trained and qualified practitioners , and its scalability is therefore limited by the costs of training and employing sufficient therapists to meet demand .
BACKGROUND	Behavioural activation ( BA ) is a psychological treatment for depression that may be an effective alternative to CBT and , because it is simpler , might also be delivered by less highly trained and specialised mental health workers .
METHODS	COBRA is a two-arm , non-inferiority , patient-level randomised controlled trial , including clinical , economic , and process evaluations comparing CBT delivered by highly trained professional therapists to BA delivered by junior professional or para-professional mental health workers to establish whether the clinical effectiveness of BA is non-inferior to CBT and if BA is cost effective compared to CBT .
METHODS	Four hundred and forty patients with major depressive disorder will be recruited through screening in primary care .
METHODS	We will analyse for non-inferiority in per-protocol and intention-to-treat populations .
METHODS	Our primary outcome will be severity of depression symptoms ( Patient Health Questionnaire-9 ) at 12 months follow-up .
METHODS	Secondary outcomes will be clinically significant change and severity of depression at 18 months , and anxiety ( General Anxiety Disorder-7 questionnaire ) and health-related quality of life ( Short-Form Health Survey-36 ) at 12 and 18 months .
METHODS	Our economic evaluation will take the United Kingdom National Health Service/Personal Social Services perspective to include costs of the interventions , health and social care services used , plus productivity losses .
METHODS	Cost-effectiveness will explored in terms of quality-adjusted life years using the EuroQol-5D measure of health-related quality of life .
CONCLUSIONS	The clinical and economic outcomes of this trial will provide the evidence to help policy makers , clinicians and guideline developers decide on the merits of including BA as a first-line treatment of depression .
BACKGROUND	Current Controlled Trials ISRCTN27473954 .

###25048074
OBJECTIVE	Eccentric muscle actions are important to the development of muscle mass and strength and may affect bone mineral density ( BMD ) .
OBJECTIVE	This study 's purpose was to determine the relative effectiveness of five different eccentric : concentric load ratios to increase musculoskeletal parameters during early adaptations to resistance training .
METHODS	Forty male subjects performed a supine leg press and calf press training program 3 days week ( -1 ) for 8 weeks .
METHODS	Subjects were matched for pre-training leg press 1-repetition maximum strength ( 1-RM ) and randomly assigned to one of five training groups .
METHODS	Concentric training load ( % 1-RM ) was constant across groups , but within groups , eccentric load was 0 , 33 , 66 , 100 , or 138 % of concentric load .
METHODS	Muscle mass ( dual energy X-ray absorptiometry ; DXA ) , strength ( 1-RM ) , and BMD ( DXA ) were measured pre - and post-training .
METHODS	Markers of bone metabolism were assessed pre - , mid - and post-training .
RESULTS	The increase in leg press 1-RM in the 138 % group ( 20 4 % ) was significantly greater ( P < 0.05 ) than the 0 % ( 8 3 % ) , 33 % ( 8 5 % ) and 66 % ( 8 4 % ) groups , but not the 100 % group ( 13 6 % ; P = 0.15 ) .
RESULTS	All groups , except the 0 % group , increased calf press 1-RM ( P < 0.05 ) .
RESULTS	Leg lean mass and greater trochanter BMD were increased only in the 138 % group ( P < 0.05 ) .
CONCLUSIONS	Early-phase adaptations to eccentric overload training include increases in muscle mass and site-specific increases in BMD and muscle strength which are not present or are less with traditional and eccentric underload training .
CONCLUSIONS	Eccentric overload provides a robust musculoskeletal stimulus that may benefit bedridden patients , individuals recovering from injury or illness , and astronauts during spaceflight .

###24284249
OBJECTIVE	To explore the effects of parecoxib sodium analgesia on serum concentrations of neuron-specific enolase ( NSE ) and S-100 and postoperative cognitive function of elderly patients undergoing acute replacement of femoral head .
METHODS	After the approval of institutional review board and the provision of informed consent , 80 patients over 70 years old , undergoing acute replacement of femoral head under combined spinal and epidural anesthesia and midazolam sedation at Qingdao Municipal Hospital and Qingdao Hiser Medical Center from January 2011 to May 2012 , were randomly assigned into control group ( group C , n = 40 ) and parecoxib group ( group P , n = 40 ) .
METHODS	In group P , parecoxib sodium 20/40 mg ( based on weight 50 kg ) was administered via an intravenous injection after admission with 12 hours intervals for six times .
METHODS	In group C , morphine 2/4 mg was given initially .
METHODS	Additional morphine 2 mg was given to maintain the pain visual analog scale ( VAS ) of 3 points or less in both groups .
METHODS	Primary observation indices : ( 1 ) postoperative time and additional amount of morphine ; ( 2 ) rate of postoperative delirium ( POD ) and postoperative cognitive dysfunction ( POCD ) at 3 days , 1 week , 3 months and 6 months postoperation ( T1-T4 ) ; ( 3 ) se rum levels of NSE and S-100 were measured at the timepoints of before analgesia ( t0 ) , before anesthesia ( t1 ) , end of surgery ( t2 ) and 6 hours , 24 hours , 48 hours postoperation ( t3-t5 ) ; ( 4 ) other serious complications .
RESULTS	Compared with group C , the additional amount of morphine , postoperative time , rate of POD and POCD at T1-T4 , the level of NSE at t2-t5 and S-100 at t1-t5 were lower in group P ( P < 0.05 ) .
RESULTS	No other serious complications were observed .
CONCLUSIONS	Parecoxib sodium analgesia reduces the rate of POD and POCD in elderly patients with neuroprotective effects .

###24809366
BACKGROUND	Pattern differentiation and diagnosis are fundamental principles of Traditional Chinese Medicine ( TCM ) .
BACKGROUND	Studies have shown low inter-rater reliability in TCM pattern diagnoses .
BACKGROUND	This variability may originate from both the identification and the interpretation of symptoms and signs .
OBJECTIVE	To examine the inter-rater reliability in TCM pattern diagnoses made in the style of Maciocia for 25 case histories by eight acupuncturists and to explore the impact of demographic factors on the diagnostic conclusion .
OBJECTIVE	Further , the association between the diagnosis and the presence of symptoms was examined for a single TCM diagnosis .
METHODS	Eight acupuncturists independently diagnosed 25 women ( 15 fertile , 10 infertile ) based on written case histories .
METHODS	Descriptive statistics , logistic regression and inter-rater reliability ( ) were used .
RESULTS	Poor inter-rater reliability on TCM patterns ( < 0.20 ) and large variation in the number of TCM pattern diagnoses were found .
RESULTS	Sex , duration of practice and education had a highly significant effect ( p < 0.001 ) on the use of TCM patterns and working hours had a significant effect ( p = 0.029 ) .
RESULTS	There was considerable intra - and inter-rater variation in the use of symptoms to make a diagnosis .
RESULTS	Symptoms occurring frequently as well as infrequently were inconsistently used to diagnose Liver Qi Stagnation .
RESULTS	The study was limited by a small sample size .
CONCLUSIONS	The results showed extensive variation and poor inter-rater reliability in TCM diagnoses .
CONCLUSIONS	Demographic variables influenced the frequency of diagnoses and symptoms were used inconsistently to set a diagnosis .
CONCLUSIONS	The variability shown could impede individually tailored treatment .

###24638015
OBJECTIVE	This randomized phase III trial was conducted to confirm noninferiority of amrubicin plus cisplatin ( AP ) compared with irinotecan plus cisplatin ( IP ) in terms of overall survival ( OS ) in chemotherapy-naive patients with extensive-disease ( ED ) small-cell lung cancer ( SCLC ) .
METHODS	Chemotherapy-naive patients with ED-SCLC were randomly assigned to receive IP , composed of irinotecan 60 mg/m ( 2 ) on days 1 , 8 , and 15 and cisplatin 60 mg/m ( 2 ) on day 1 every 4 weeks , or AP , composed of amrubicin 40 mg/m ( 2 ) on days 1 , 2 , and 3 and cisplatin 60 mg/m ( 2 ) on day 1 every 3 weeks .
RESULTS	A total of 284 patients were randomly assigned to IP ( n = 142 ) and AP ( n = 142 ) arms .
RESULTS	The point estimate of OS hazard ratio ( HR ) for AP to IP in the second interim analysis exceeded the noninferior margin ( HR , 1.31 ) , resulting in early publication because of futility .
RESULTS	In updated analysis , median survival time was 17.7 ( IP ) versus 15.0 months ( AP ; HR , 1.43 ; 95 % CI , 1.10 to 1.85 ) , median progression-free survival was 5.6 ( IP ) versus 5.1 months ( AP ; HR , 1.42 ; 95 % CI , 1.16 to 1.73 ) , and response rate was 72.3 % ( IP ) versus 77.9 % ( AP ; P = .33 ) .
RESULTS	Adverse events observed in IP and AP arms were grade 4 neutropenia ( 22.5 % v 79.3 % ) , grade 3 to 4 febrile neutropenia ( 10.6 % v 32.1 % ) , and grade 3 to 4 diarrhea ( 7.7 % v 1.4 % ) .
CONCLUSIONS	AP proved inferior to IP in this trial , perhaps because the efficacy of amrubicin as a salvage therapy was differentially beneficial to IP .
CONCLUSIONS	IP remains the standard treatment for extensive-stage SCLC in Japan .

###24581318
BACKGROUND	It has been reported that the direction of the guidewire J-tip is associated with misplacement of a central venous catheter .
BACKGROUND	We hypothesized that real-time ultrasound-guided infraclavicular subclavian venous cannulation would be less influenced by the direction of guidewire J-tip compared to landmark method .
METHODS	Sixty adult patients who required subclavian venous catheterization for neurosurgery were enrolled in this prospective randomized controlled study .
METHODS	Patients were randomly divided into a landmark group ( n = 30 ) or an ultrasound group ( n = 30 ) .
METHODS	After the subclavian vein was punctured , the guidewire was advanced with the guidewire J-tip directed cephalad .
METHODS	Misplacement or advancement failure of the guidewire was regarded as an unsuccessful placement .
METHODS	Postoperative chest radiography was performed to confirm pneumothorax and the location of the catheter tip .
RESULTS	The two groups were comparable with respect to age , gender , height , and weight distribution .
RESULTS	The incidence of unsuccessful guidewire placement was lower in the ultrasound group than in the landmark group ( 13 % vs. 47 % , P = 0.01 ) .
RESULTS	Among the unsuccessful guidewire placements , the incidence of misplacement were comparable between the groups and were all located in the ipsilateral internal jugular vein ( 7 % vs. 7 % ) .
RESULTS	However , the incidence of advancement failure was significantly higher in landmark group ( 40 % vs. 7 % , P = 0.005 ) .
RESULTS	There were no complications such as pneumothorax or hemothorax .
CONCLUSIONS	The proper placement of guidewire was less influenced by the direction of the guidewire J-tip with ultrasound-guided subclavian venous cannulation than with the landmark approach .

###25568167
BACKGROUND	Human papillomavirus ( HPV ) - based screening needs triage .
BACKGROUND	In most randomized controlled trials ( RCTs ) on HPV testing with cytological triage , cytology interpretation has been blind to HPV status .
METHODS	Women age 25 to 60 years enrolled in the New Technology in Cervical Cancer ( NTCC ) RCT comparing HPV testing with cytology were referred to colposcopy if HPV positive and , if no cervical intraepithelial neoplasia ( CIN ) was detected , followed up until HPV negativity .
METHODS	Cytological slides taken at the first colposcopy were retrieved and independently interpreted by an external laboratory , which was only aware of patients ' HPV positivity .
METHODS	Sensitivity , specificity , and positive ( PPV ) and negative ( NPV ) predictive values were computed for histologically proven CIN2 + with HPV status-informed cytology for women with a determination of atypical squamous cells of undetermined significance ( ASCUS ) or more severe .
METHODS	All statistical tests were two-sided .
RESULTS	Among HPV-positive women , informed cytology had cross-sectional sensitivity , specificity , PPV and 1-NPV for CIN2 + of 85.6 % ( 95 % confidence interval [ CI ] = 76.6 to 92.1 ) , 65.9 % ( 95 % CI = 63.1 to 68.6 ) , 16.2 % ( 95 % CI = 13.0 to 19.8 ) , and 1.7 ( 95 % CI = 0.9 to 2.8 ) , respectively .
RESULTS	Cytology was also associated with subsequent risk of newly diagnosed CIN2 + and CIN3 + .
RESULTS	The cross-sectional relative sensitivity for CIN2 + vs blind cytology obtained by referring to colposcopy and following up only HPV positive women who had HPV status-informed cytology greater than or equal to ASCUS was 1.58 ( 95 % CI = 1.22 to 2.01 ) , while the corresponding relative referral to colposcopy was 0.95 ( 95 % CI = 0.86 to 1.04 ) .
CONCLUSIONS	Cytology informed of HPV positivity is more sensitive than blind cytology and could allow longer intervals before retesting HPV-positive , cytology-negative women .

###25624368
OBJECTIVE	We tested the hypothesis that observationally and genetically elevated YKL-40 is associated with elevated lipids and lipoproteins and with increased risk of ischemic vascular disease .
METHODS	We conducted cohort and Mendelian randomization studies in 96 110 individuals from the Danish general population , with measured plasma levels of YKL-40 ( n = 21 647 ) , plasma lipids and lipoproteins ( n = 94 461 ) , and CHI3L1 rs4950928 genotype ( n = 94 579 ) .
RESULTS	From 1977 to 2013 , 3256 individuals developed ischemic stroke , 5629 ischemic cerebrovascular disease , 4183 myocardial infarction , and 10 271 developed ischemic heart disease .
RESULTS	The 91 % to 100 % versus 0 % to 33 % YKL-40 percentile category was associated with a 34 % increase in triglycerides , but only with minor changes in other lipids and lipoproteins .
RESULTS	For these categories , the multifactorially adjusted hazard ratio was 1.99 ( 95 % confidence interval , 1.49-2 .67 ) for ischemic stroke , 1.85 ( 1.44-2 .37 ) for ischemic cerebrovascular disease , 1.28 ( 0.95-1 .73 ) for myocardial infarction , and 1.23 ( 1.01-1 .51 ) for ischemic heart disease .
RESULTS	When compared with rs4950928 CC homozygosity , the presence of G-allele was associated with a doubling ( GC ) or tripling ( GG ) in YKL-40 levels , but not with triglyceride levels or with risk of ischemic vascular disease .
RESULTS	A doubling in YKL-40 was associated with a multifactorially adjusted observational hazard ratio for ischemic stroke of 1.18 ( 1.11-1 .27 ) , and a genetic odds ratio of 1.04 ( 0.95-1 .15 ) .
RESULTS	Corresponding risk estimates were 1.15 ( 1.09-1 .22 ) observationally and 1.06 ( 0.99-1 .14 ) genetically for ischemic cerebrovascular disease , 1.08 ( 1.00-1 .15 ) observationally and 1.04 ( 0.96-1 .13 ) genetically for myocardial infarction , and 1.07 ( 1.02-1 .12 ) observationally and 1.01 ( 0.96-1 .07 ) genetically for ischemic heart disease .
CONCLUSIONS	Elevated YKL-40 was associated with a 34 % increase in triglyceride levels and with a 2-fold increased risk of ischemic stroke , whereas genetically elevated YKL-40 were not .

###24368753
OBJECTIVE	The association of QRS duration ( QRSd ) with morbidity and mortality is understudied in patients with atrial fibrillation ( AF ) .
OBJECTIVE	We sought to assess any association of prolonged QRS with increased risk of death or hospitalization among patients with AF .
RESULTS	QRS duration was retrieved from the baseline electrocardiograms of patients enroled in the Atrial Fibrillation Follow-Up Investigation of Rhythm Management ( AFFIRM ) study and divided into three categories : < 90 , 90-119 , 120 ms. Cox models were applied relating the hazards of mortality and hospitalizations to QRSd .
RESULTS	Among 3804 patients with AF , 593 died and 2305 were hospitalized .
RESULTS	Compared with those with QRS < 90 ms , patients with QRS 120 ms , had an increased mortality [ hazard ratio ( HR ) 1.61 , 95 % confidence interval ( CI ) : 1.29-2 .03 , P < 0.001 ] and hospitalizations ( HR 1.14 , 95 % CI : 1.07-1 .34 , P = 0.043 ) over an average follow-up of 3.5 years .
RESULTS	Importantly , for patients with QRS 90-119 ms , mortality and hospitalization were also increased ( HR 1.31 , P = 0.005 and 1.11 , P = 0.026 , respectively ) .
RESULTS	In subgroup analysis based on heart failure ( HF ) status ( previously documented or ejection fraction < 40 % ) , mortality was increased for QRS 120 ms patients with ( HR 1.87 , P < 0.001 ) and without HF ( HR 1.63 , P = 0.02 ) .
RESULTS	In the QRS 90-119 ms group , mortality was increased ( HR 1.38 , P = 0.03 ) for those with HF , but not significantly among those without HF ( HR 1.23 , P = 0.14 ) .
CONCLUSIONS	Among patients with AF , QRSd 120 ms was associated with a substantially increased risk for mortality ( all-cause , cardiovascular , and arrhythmic ) and hospitalization .
CONCLUSIONS	Interestingly , an increased mortality was also observed among those with QRS 90-119 ms and concomitant HF .

###24622117
OBJECTIVE	This study sought to examine the association between thyroid status and clinical outcomes in patients in the CORONA ( Controlled Rosuvastatin Multinational Trial in Heart Failure ) study .
BACKGROUND	Hypo - and hyperthyroidism were associated with worse clinical outcomes in the SCD-HeFT ( Sudden Cardiac Death in Heart Failure Trial ) .
METHODS	In CORONA , 4,987 patients underwent baseline thyroid-stimulating hormone ( TSH ) measurement , 237 of which ( 4.8 % ) were receiving thyroid replacement therapy ( TRT ) .
METHODS	Patients were classified as euthyroid ( TSH : 0.3 to 5.0 U/ml , and no TRT ) , hyperthyroid ( < 0.3 U/ml and no TRT ) , or hypothyroid ( > 5.0 U/ml and no TRT ) .
METHODS	The outcome composites of cardiovascular ( CV ) death or hospitalization for heart failure ( HF ) , the components of this composite , and all-cause death were compared among hyperthyroid , hypothyroid , and euthyroid states , using multivariable models adjusting for previously reported prognostic variables .
RESULTS	A total of 91.3 % of patients were euthyroid , 5.0 % were hypothyroid , and 3.7 % were hyperthyroid .
RESULTS	Compared with euthyroid patients , hypothyroid patients were more likely to have a history of stroke , had worse renal function and higher N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) levels , were more likely to be treated with an antiarrhythmic drug ( or have an implantable cardioverter defibrillator ) , and were less likely to smoke or be treated with a beta-blocker or angiotensin-converting enzyme inhibitor/angiotensin receptor blocker .
RESULTS	In univariate analyses , hypothyroidism was associated with an increased risk of the composite outcome of CV death or HF hospitalization ( hazard ratio : 1.29 ; 95 % confidence interval : 1.07 to 1.57 ; p = 0.008 ) , as well as all-cause death ( HR : 1.36 ; 95 % confidence interval : 1.03 to 1.76 ; p = 0.004 ) .
RESULTS	However , after adjustment for other known predictors of outcome , the associations were weakened , and when NT-proBNP was added to the models , the association between hypothyroidism and all outcomes was eliminated .
CONCLUSIONS	Thyroid status is not an independent predictor of outcome in heart failure with reduced ejection fraction .
CONCLUSIONS	( Controlled Rosuvastatin Multinational Study in Heart Failure [ CORONA ] ; NCT00206310 ) .

###25663221
OBJECTIVE	To report long-term efficacy and safety results of the SANTE trial investigating deep brain stimulation of the anterior nucleus of the thalamus ( ANT ) for treatment of localization-related epilepsy .
METHODS	This long-term follow-up is a continuation of a previously reported trial of 5 - vs 0-V ANT stimulation .
METHODS	Long-term follow-up began 13 months after device implantation with stimulation parameters adjusted at the investigators ' discretion .
METHODS	Seizure frequency was determined using daily seizure diaries .
RESULTS	The median percent seizure reduction from baseline at 1 year was 41 % , and 69 % at 5 years .
RESULTS	The responder rate ( 50 % reduction in seizure frequency ) at 1 year was 43 % , and 68 % at 5 years .
RESULTS	In the 5 years of follow-up , 16 % of subjects were seizure-free for at least 6 months .
RESULTS	There were no reported unanticipated adverse device effects or symptomatic intracranial hemorrhages .
RESULTS	The Liverpool Seizure Severity Scale and 31-item Quality of Life in Epilepsy measure showed statistically significant improvement over baseline by 1 year and at 5 years ( p < 0.001 ) .
CONCLUSIONS	Long-term follow-up of ANT deep brain stimulation showed sustained efficacy and safety in a treatment-resistant population .
METHODS	This long-term follow-up provides Class IV evidence that for patients with drug-resistant partial epilepsy , anterior thalamic stimulation is associated with a 69 % reduction in seizure frequency and a 34 % serious device-related adverse event rate at 5 years .

###24647863
OBJECTIVE	To investigate the effects of elastic tubing training compared with conventional resistance training on the improvement of functional exercise capacity , muscle strength , fat-free mass , and systemic inflammation in patients with chronic obstructive pulmonary disease .
METHODS	A prospective , randomized , eight-week clinical trial .
METHODS	The study was conducted in a university-based , outpatient , physical therapy clinic .
METHODS	A total of 49 patients with moderate chronic obstructive pulmonary disease .
METHODS	Participants were randomly assigned to perform elastic tubing training or conventional resistance training three times per week for eight weeks .
METHODS	The primary outcome measure was functional exercise capacity .
METHODS	The secondary outcome measures were peripheral muscle strength , health-related quality of life assessed by the Chronic Respiratory Disease Questionnaire ( CRDQ ) , fat-free mass , and cytokine profile .
RESULTS	After eight weeks , the mean distance covered during six minutes increased by 73 meters ( 69 ) in the elastic tubing group and by 42 meters ( 59 ) in the conventional group ( p < 0.05 ) .
RESULTS	The muscle strength and quality of life improved in both groups ( P < 0.05 ) , with no significant differences between the groups .
RESULTS	There was a trend toward an improved fat-free mass in both groups ( P = 0.05 ) .
RESULTS	After the first and last sessions , there was an increase in interleukin 1 ( IL-1 ) and interleukin 10 ( IL-10 ) in both groups , while tumour necrosis factor alpha ( TNF - ) was stimulated only in the conventional training group .
CONCLUSIONS	Elastic tubing training had a greater effect on functional exercise capacity than conventional resistance training .
CONCLUSIONS	Both interventions were equally effective in improving muscle strength and quality of life .

###24245845
OBJECTIVE	To determine whether daily self-weighing ( DSW ) is associated with disordered eating ( DE ) symptoms within an adult lifestyle intervention ( LI ) , and to examine changes in DE symptoms during the 18-month trial .
METHODS	One-hundred and seventy-eight adults ( 53 % female , 90 % White , 52.0 8.6 years , BMI = 35.0 4.4 kg/m2 ) were enrolled in a randomized trial testing 2 dietary prescriptions within a LI ( standard vs. limited dietary variety ) .
METHODS	Both arms were taught DSW and had the same contact schedule and calorie and activity goals .
METHODS	Frequency of weighing and DE were assessed at 0 , 6 , 12 , and 18 months .
METHODS	Analyses controlled for treatment arm .
RESULTS	At baseline , 16.3 % of participants reported weighing daily compared with 83.7 % , 72.3 % , and 68.2 % at 6 , 12 , and 18 months , respectively .
RESULTS	There was no relationship between change in frequency of self-weighing and change in DE symptoms at any time point .
RESULTS	Further , there were no significant differences between those who weighed daily versus < daily on DE composite scores at baseline or 6 months ; at 12 and 18 months participants who weighed daily reported lower DE scores compared with those who weighed < daily ( p = .008 and .043 at 12 and 18 months , respectively ) .
RESULTS	Participants who weighed daily achieved better weight losses than those weighing < daily at 12 and 18 months ( p = .003 and < .001 ) .
RESULTS	There was a significant reduction over time in DE symptoms ( p < .0001 ) and a reduction in odds of meeting criteria for Binge Eating Disorder ( BED ; ps < .001 ) .
CONCLUSIONS	Daily self-weighing did not appear to be related to increased disordered eating behavior and was associated with better weight loss outcomes .

###24792937
BACKGROUND	The benefit of antibiotic prophylaxis for simple hand lacerations ( lacerations that do not involve special structures ) has not been adequately studied .
OBJECTIVE	To assess the feasibility of a randomized controlled trial to determine the role of antibiotic prophylaxis in emergency department ( ED ) patients with simple hand lacerations .
METHODS	Randomized , double-blind , placebo-controlled pilot trial in 2 urban academic EDs .
METHODS	Adult ( 18 years old ) patients with simple hand lacerations were randomized to cephalexin , 500 mg ; clindamycin , 300 mg ; or placebo ( every 6 hours for 7 days , all in identical capsules ) .
RESULTS	( 1 ) feasibility determined by the number of patients who agreed to enroll and number of patients who completed follow-up , ( 2 ) infection rate ( determined by 2 physicians at 10-14 days ) , ( 3 ) satisfaction with wound appearance ( measured by a visual analogue scale at 30 days via phone ) .
RESULTS	Medians , quartiles , and percentages with 95 % confidence intervals ( CI ) were used to present data .
RESULTS	Groups were compared with Kruskal-Wallis and Fisher exact tests , when appropriate .
RESULTS	Over a 5-month period , 123 patients were approached , and 78 consented to enrollment ( 63 % ; 95 % CI , 55-71 % ) .
RESULTS	Five were lost to follow-up ( 5/78 , 6 % ; 95 % CI , 2 % -14 % ) .
RESULTS	Only one patient had infection on follow-up for an infection rate of 1 % ( 95 % CI , 0.01 % -8 % ) .
RESULTS	Patient 's satisfaction with wound appearance did not differ among the groups .
CONCLUSIONS	The findings of this pilot study support the feasibility of a randomized , double-blind , controlled trial .
CONCLUSIONS	The low rate of infection suggests the need of a large sample size for the trial .

###24530156
OBJECTIVE	To determine the effect of prior oophorectomy in healthy postmenopausal women on the rate of loss of bone mineral density ( BMD ) and rate of increase in carotid artery intima-media thickness ( CIMT ) .
METHODS	Secondary analysis from a randomized controlled trial .
METHODS	University-based research clinic .
METHODS	Two hundred twenty-two healthy postmenopausal women in the Greater Los Angeles area .
METHODS	Baseline and annual screening of BMD and assessment of CIMT every 6 months for a total of 3 years .
METHODS	Changes in BMD and CIMT during postmenopausal years .
RESULTS	Among women who were menopausal for more than 10 years , the rate of CIMT progression was statistically significantly less in women with intact ovaries compared with those in women with prior oophorectomy .
RESULTS	In women 5-10 years postmenopause , there was a trend toward a slower loss of BMD in those who retained their ovaries , and in women more than 10 years postmenopause there was significantly less BMD loss in those who retained their ovaries .
CONCLUSIONS	As time from menopausal transition increases , retained ovaries are associated with a slower rate of bone loss and a slower rate of thickening of the carotid artery wall compared with rates in menopausal women with oophorectomy .

###24558011
OBJECTIVE	To investigate the hypothesis that paracetamol is absorbed faster from a hot drink than from a standard tablet using simultaneous scintigraphic imaging and pharmacokinetic sampling .
METHODS	Twenty-five healthy male volunteers received both paracetamol formulations in a randomised manner .
METHODS	The formulation administered in the first treatment arm was radiolabelled to allow scintigraphic monitoring .
METHODS	In both treatment arms , blood samples were taken for assessing paracetamol absorption .
RESULTS	Following the hot drink , paracetamol absorption was both significantly faster and greater over the first 60min post-dose compared with the tablet , as evidenced by the median time to reach t0 .25 g/mL of 4.6 and 23.1 min , respectively , and AUC0-60 of 4668.00 and 1331.17 h * ng/mL , respectively .
RESULTS	In addition , tmax was significantly shorter for the hot drink ( median time = 1.50 h ) compared with the tablet ( 1.99 h ) .
RESULTS	However , Cmax was significantly greater following the tablet ( 9,077 ng/mL ) compared with the hot drink ( 8,062 ng/mL ) .
RESULTS	Onset of gastric emptying after the hot drink was significantly faster than after the standard tablet ( 7.9 versus 54.2 min ) , as confirmed scintigraphically .
CONCLUSIONS	Compared with a standard tablet , a hot drink provides faster absorption of paracetamol potentially due to more rapid gastric emptying .

###25179033
BACKGROUND	Despite its documented importance , communication between clinicians and patients ' families in the intensive care unit often fails to meet families ' needs , and interventions to improve communication are needed .
BACKGROUND	Use of a communication facilitator-an additional staff member-to improve communication between clinicians and patients ' families is the focus of an ongoing randomized trial .
BACKGROUND	The clinical team 's acceptance of the communication facilitator as an integral part of the team is important .
OBJECTIVE	To explore clinicians ' perceptions of the usefulness of a communication facilitator in the intensive care unit .
METHODS	Fourteen semistructured qualitative interviews to assess perspectives of physicians , nurses , and social workers who had experience with the communication facilitator intervention on the intervention and the role of the facilitator .
METHODS	Methods based on grounded theory were used to analyze the data .
RESULTS	Clinicians perceived facilitators as ( 1 ) facilitating communication between patients ' families and clinicians , ( 2 ) providing practical and emotional support for patients ' families , and ( 3 ) providing practical and emotional support for clinicians .
RESULTS	Clinicians were enthusiastic about the communication facilitator but concerned about overlapping or conflicting roles .
CONCLUSIONS	Clinicians in the intensive care unit saw the facilitator intervention as enhancing communication and supporting both patients ' families and clinicians .
CONCLUSIONS	They also identified the importance of the facilitator within the interdisciplinary team .
CONCLUSIONS	Negative perceptions about the use of a facilitator should be addressed before the intervention is implemented , in order to ensure its effectiveness .

###24739445
BACKGROUND	The impact of boosted protease inhibitor therapy on inflammatory and cardiovascular biomarker levels in treatment-naive HIV-infected patients remains unclear and may differ between agents .
BACKGROUND	Unconjugated bilirubin elevation , which favourably affects vascular biomarkers and cardiovascular disease risk in Gilbert 's syndrome , occurs with atazanavir .
METHODS	CASTLE was a 96-week study comparing efficacy and safety in treatment-naive HIV-1-infected patients randomized to atazanavir/ritonavir ( ATV/r ) versus lopinavir/ritonavir ( LPV/r ) , each in combination with tenofovir disoproxil fumarate/emtricitabine .
METHODS	In this substudy , fasting plasma tumour necrosis factor - ( TNF - ) , interleukin-6 ( IL-6 ) , high sensitivity C-reactive protein ( hs-CRP ) , plasminogen activator inhibitor-1 ( PAI-1 ) and fibrinogen were assessed at baseline , week 12 , 24 , 48 and 96 .
METHODS	Impact of grade 3-4 hyperbilirubinaemia on biomarkers was examined .
RESULTS	CASTLE demonstrated similar efficacy in both treatment arms with higher rates of hyperbilirubinaemia on ATV/r and elevated lipids on LPV/r .
RESULTS	In this substudy ( n = 224 ) , patterns of biomarker expression were similar between the ATV/r and LPV/r groups and between-group differences in biomarker percentage change from baseline were not significant at 48 and/or 96 weeks .
RESULTS	Hyperbilirubinaemia did not influence fasting biomarker expression .
CONCLUSIONS	No significant differences were noted between ATV/r and LPV/r for biomarker percentage changes from baseline .
CONCLUSIONS	Furthermore , no association was found between total bilirubin levels and biomarker expression .

###24606670
BACKGROUND	Bone graft substitutes are widely used for reconstruction of posttraumatic bone defects .
BACKGROUND	However , their clinical significance in comparison to autologous bone grafting , the gold-standard in reconstruction of larger bone defects , still remains under debate .
BACKGROUND	This prospective , randomized , controlled clinical study investigates the differences in pain , quality of life , and cost of care in the treatment of tibia plateau fractures-associated bone defects using either autologous bone grafting or bioresorbable hydroxyapatite/calcium sulphate cement ( CERAMENT | BONE VOID FILLER ( CBVF ) ) .
METHODS	CERTiFy ( CERament Treatment of Fracture defects ) is a prospective , multicenter , controlled , randomized trial .
METHODS	We plan to enroll 136 patients with fresh traumatic depression fractures of the proximal tibia ( types AO 41-B2 and AO 41-B3 ) in 13 participating centers in Germany .
METHODS	Patients will be randomized to receive either autologous iliac crest bone graft or CBVF after reduction and osteosynthesis of the fracture to reconstruct the subchondral bone defect and prevent the subsidence of the articular surface .
METHODS	The primary outcome is the SF-12 Physical Component Summary at week 26 .
METHODS	The co-primary endpoint is the pain level 26 weeks after surgery measured by a visual analog scale .
METHODS	The SF-12 Mental Component Summary after 26 weeks and costs of care will serve as key secondary endpoints .
METHODS	The study is designed to show non-inferiority of the CBVF treatment to the autologous iliac crest bone graft with respect to the physical component of quality of life .
METHODS	The pain level at 26 weeks after surgery is expected to be lower in the CERAMENT bone void filler treatment group .
CONCLUSIONS	CERTiFy is the first randomized multicenter clinical trial designed to compare quality of life , pain , and cost of care in the use of the CBVF and the autologous iliac crest bone graft in the treatment of tibia plateau fractures .
CONCLUSIONS	The results are expected to influence future treatment recommendations .
BACKGROUND	ClinicalTrials.gov : NCT01828905 .

###24866923
OBJECTIVE	This study assesses the effect of sending a Survivorship Care Plan ( SCP ) to primary care physicians ( PCP ) on the communication of the PCP with the medical specialist and the patient and to describe PCPs ' opinions regarding the SCP .
METHODS	In a pragmatic cluster randomized controlled trial conducted in 12 hospitals , the PCP of endometrial and ovarian cancer patients received usual information , while in addition the SCP-care arm received a copy of the patient 's SCP .
RESULTS	A questionnaire was returned by 266 PCPs ( 76 % ) .
RESULTS	One third of the PCPs in the SCP-care arm indicated having received an SCP .
RESULTS	PCPs in the SCP-care arm were more likely to have had personal contact with the medical specialist ( 52 vs. 37 % , p = 0.01 ) but were equally satisfied with the information as PCPs in the usual care arm ( 7.2 vs. 6.9 on a scale from 1 to 10 , p = 0.25 ) .
RESULTS	Of all PCPs , 82 % indicated they would want to receive an SCP in the future .
RESULTS	A quarter of the PCPs who received an SCP reported that the SCP supported contact with the patient .
RESULTS	However , the SCP was found too long .
CONCLUSIONS	Supplying an SCP to PCPs potentially has a positive effect on the communication between the PCP and the medical specialist .
CONCLUSIONS	The SCP should be concise and focused on PCPs ' needs , such as contact information and tailored information on patient diagnosis , treatment , and possible consequences .
CONCLUSIONS	In the light of transition of cancer care to PCPs , survivors may benefit from improved information provision and communication .

###24619865
BACKGROUND	Resistance exercise ( RE ) may lead to a post-exercise hypotension ( PEH ) response .
BACKGROUND	Previous studies showed that green tea ( GT ) and its polyphenols , especially Epigallocatechin-3-gallate ( EGCG ) may have a favorable effect on blood pressure ( BP ) .
OBJECTIVE	We investigated the green tea extract ( GTE ) effects on BP , heart rate ( HR ) , and rate pressure product ( RPP ) responses to a low-intensity RE in hypertensive women .
METHODS	Middle-aged women ( n = 24 , 46.4 6.3 years old ; 66.6 9.2 kg ; 166.3 4.2 cm ) were randomly assigned into three groups of eight persons .
METHODS	GTE consumption group ( T ) and RE group ( R ) , respectively , ingested GTE ( ~ 75 mg EGCG ) and placebo ( PL ; maltodextrin ) capsules two times a day for three weeks and then completed 2 circuits of six RE using 50 % one repetition maximum ( 1RM ) .
METHODS	Patients of control group ( C ) just ingested PL and rested in a non-exercise control trial .
METHODS	BP , HR and RPP were measured prior and post-exercise at 0 , 15 , 30 , 45 , and 60 min .
RESULTS	The repeated measures analysis of variance ( ANOVA ) revealed that there were no significant alterations for arterial BP , HR and RPP of C group .
RESULTS	HR of T and R groups was increased immediately after RE .
RESULTS	A significant fall of systolic BP ( SBP ) and diastolic BP ( DBP ) occurred in both T and R groups for 60 min post-exercise compared to resting values .
RESULTS	Mean arterial BP ( MAP ) and RPP decreased significantly after RE in both exercise groups from 15 to 60 min .
RESULTS	During 45 and 60 time points , T group had a lower RPP values than C group .
RESULTS	The differences between T and R groups were only MAP at 0 and 15 time points .
CONCLUSIONS	Three weeks of GTE ingestion did not influenced SBP , DBP and HR but may be have a favorable effect on MAP and RPP responses to an acute RE during 1 h recovery of exercise .

###24534410
OBJECTIVE	This study was done to compare 2 techniques of pulse oximeter sensor application during neonatal resuscitation for faster signal detection .
METHODS	Sensor to infant first ( STIF ) and then to oximeter was compared with sensor to oximeter first ( STOF ) and then to infant in 28 weeks gestations .
METHODS	The primary outcome was time from completion of sensor application to reliable signal , defined as stable display of heart rate and saturation .
METHODS	Time from birth to sensor application , time taken for sensor application , time from birth to reliable signal , and need to reapply sensor were secondary outcomes .
METHODS	An intention-to-treat analysis was done , and subgroup analysis was done for gestation and need for resuscitation .
RESULTS	One hundred fifty neonates were randomized with 75 to each technique .
RESULTS	The median ( IQR ) time from sensor application to detection of reliable signal was longer in STIF group compared with STOF group ( 16 [ 15-17 ] vs. 10 [ 6-18 ] seconds ; P < 0.001 ) .
RESULTS	Time taken for application of sensor was longer with STIF technique than with STOF technique ( 12 [ 10-16 ] vs. 11 [ 9-15 ] seconds ; P = 0.04 ) .
RESULTS	Time from birth to reliable signal did not differ between the 2 methods ( STIF : 61 [ 52-76 ] seconds ; STOF : 58 [ 47-73 ] seconds [ P = .09 ] ) .
RESULTS	Time taken for signal acquisition was longer with STIF than with STOF in both subgroups .
CONCLUSIONS	In the delivery room setting , the STOF method recognized saturation and heart rate faster than the STIF method .
CONCLUSIONS	The time from birth to reliable signal was similar with the 2 methods .

###24919799
OBJECTIVE	Neocollagenesis can be achieved using a dermal rolling needle device , thereby reducing the appearance of acne scars .
OBJECTIVE	To determine the efficacy of a needling device for treatment of acne scars .
METHODS	We performed a single-center , rater-blinded , balanced ( 1:1 ) , split-face , placebo-controlled , parallel-group randomized clinical trial at an urban academic institution .
METHODS	The study took place from November 30 , 2009 , through July 27 , 2010 .
METHODS	Twenty healthy adults ( age range , 20-65 years ) with acne scars on both sides of the face were enrolled .
METHODS	Fifteen individuals completed the study , and no enrolled participants were withdrawn for adverse effects .
METHODS	For each participant , one side of the face was randomized for needling .
METHODS	Three needling treatments were performed at 2-week intervals .
METHODS	Two blinded dermatologists separately rated participants ' acne scars based on standard digital photographs obtained at baseline and at the 3-month and 6-month follow-up visits on the quantitative global scarring grading system .
RESULTS	Mean scar scores were significantly lower in the treatment group compared with baseline at 6 months ( mean difference , 3.4 ; 95 % CI , 0.2-6 .5 ; P = .03 ) and nominally but not significantly lower compared with baseline at 3 months ( mean difference , 2.4 ; 95 % CI , -0.01 to 4.8 ; P = .052 ) .
RESULTS	In the control group , mean scar scores did not vary significantly from baseline at 3 months ( mean difference , 1.0 ; 95 % CI , -1.4 to 3.4 ; P = .96 ) and at 6 months ( mean difference , 0.4 ; 95 % CI , -2.3 to 3.5 ; P > .99 ) .
RESULTS	The needling procedure was not particularly painful , with a mean pain rating of 1.08 of 10 .
RESULTS	Participants perceived a 41 % mean improvement in overall scar appearance on the treated side .
RESULTS	No adverse events were reported .
CONCLUSIONS	After 3 needling treatments , there was improvement in the appearance of acne scars over time compared with the control group , with minimal pain reported .
BACKGROUND	clinicaltrials.gov Identifier : NCT00974870 .

###24828386
OBJECTIVE	Pro-inflammatory mediators are thought to play both peripheral and central roles in migraine pathophysiology .
OBJECTIVE	Prostaglandins and leukotrienes , known as the eicosanoids , are degradation products of arachidonic acid and constitute signalization components of inflammatory pathways .
OBJECTIVE	This study was designed to assess concentrations of leukotriene E4 ( LT-E4 ) and prostaglandin F2a ( PG-F2a ) in children with migraine .
METHODS	This study involved patients aged 18 years who presented to the Ondokuz Mayis University Children 's Hospital with migrainous headache between January and October 2011 .
METHODS	Urinary LT-E4 and PG-F2a concentrations were measured in patients during a headache episode and at a headache-free time and in a control group .
RESULTS	The patient group consisted of 38 girls and 26 boys aged 5-18 years diagnosed with migraine and having at least 6 months of headache , whereas the control group consisted of 21 girls and 29 boys .
RESULTS	Mean standard deviation ( SD ) urinary LT-E4 concentrations were significantly higher in patients during a migraine episode than in controls ( 1466.81052.5 pg/ml vs 811.6460.0 pg/ml , P < 0.001 ) .
RESULTS	In patients with migraine , both urinary LT-E4 ( P < 0.001 ) and PG-F2a ( P = 0.021 ) levels were significantly higher during headache than during non-headache periods .
CONCLUSIONS	Urinary LT-E4 and PG-F2a were both significantly higher in children with migraine during headache than during non-headache periods .
CONCLUSIONS	The elevation in the levels of these inflammatory mediators was compatible with the hypothesis relating neuroinflammation in trigeminal vascular blood vessels with migraine pathophysiology .
CONCLUSIONS	Leukotriene antagonists may be effective in the prophylaxis of migraine attacks .

###25348121
OBJECTIVE	Repeated exposure to a neutral conditioned stimulus ( CS ) in the absence of a noxious unconditioned stimulus ( US ) elicits fear memory extinction .
OBJECTIVE	The aim of the current study was to investigate the effects of mild tone exposure ( CS ) during slow wave sleep ( SWS ) on fear memory extinction in humans .
METHODS	The healthy volunteers underwent an auditory fear conditioning paradigm on the experimental night , during which tones served as the CS , and a mild shock served as the US .
METHODS	They were then randomly assigned to four groups .
METHODS	Three groups were exposed to the CS for 3 or 10 min or an irrelevant tone ( control stimulus , CtrS ) for 10 min during SWS .
METHODS	The fourth group served as controls and was not subjected to any interventions .
METHODS	All of the subjects completed a memory test 4 h after SWS-rich stage to evaluate the effect on fear extinction .
METHODS	Moreover , we conducted similar experiments using an independent group of subjects during the daytime to test whether the memory extinction effect was specific to the sleep condition .
METHODS	Ninety-six healthy volunteers ( 44 males ) aged 18-28 y.
RESULTS	Participants exhibited undisturbed sleep during 2 consecutive nights , as assessed by sleep variables ( all P > 0.05 ) from polysomnographic recordings and power spectral analysis .
RESULTS	Participants who were re-exposed to the 10 min CS either during SWS and wakefulness exhibited attenuated fear responses ( wake-10 min CS , P < 0.05 ; SWS-10 min CS , P < 0.01 ) .
CONCLUSIONS	Conditioned stimulus re-exposure during SWS promoted fear memory extinction without altering sleep profiles .

###24742146
BACKGROUND	The physical and mental health of college-age youths tends to continuously decline around the world .
BACKGROUND	It is therefore important to promote health during this period .
BACKGROUND	As a traditional Chinese mind-body exercise , Tai Chi Chuan ( TCC ) may be an available selection .
BACKGROUND	However for the college student population , the evidence is unclear as to whether TCC can be recommended as an effective exercise for promoting their physical and psychological wellbeing .
BACKGROUND	Therefore high quality , rigorous , prospective , and well-controlled randomized trials are needed to further understand TCC serving as a psychological and physical intervention in college age populations .
METHODS	We designed a randomized , single-blind , parallel-controlled trial with a sample size of 206 participants .
METHODS	All the participants who meet the inclusion criteria come from Fujian University of Traditional Chinese Medicine ( FJTCM ) .
METHODS	Participants of the TCC training group will receive TCC training at a frequency of five days per week for one hour per day for 12weeks .
METHODS	No specific exercise will be administered on the participants in the control group .
METHODS	Both physical and mental health outcomes , including balance ability , lower limb proprioception , flexibility , physical fitness , self-efficacy , psychological symptoms , attention span , stress , self-esteem , mood and mindfulness , quality of life , and quality of sleep .
METHODS	Safety outcomes will be evaluated by blinded operators at baseline , 12 and 24-weeks post-intervention .
CONCLUSIONS	This protocol presents an objective design of a randomized , single-blind trial that will test the effectiveness and safety of TCC on the physical and psychological wellbeing of college students .
CONCLUSIONS	If the outcome is positive , the results will provide higher quality evidence of TCC on the physical and mental health of college age populations .
BACKGROUND	Chinese Clinical Trial Registry : ChiCTR-TRC-13003328 .

###25316182
OBJECTIVE	To assess whether the volume of callosal hyperintensities in the genu and splenium of older adults with mobility impairment is differentially associated with the degree of gain in gait speed after 2 types of gait interventions .
METHODS	Single-blind randomized controlled trial of 2 types of gait exercises in older adults .
METHODS	Research center in an academic institution .
METHODS	Ambulatory adults ( N = 44 ) aged 65 years with a slow and variable gait .
METHODS	Twelve-week physical therapist-guided trial of a conventional walking , endurance , balance , and strength ( WEBS ) intervention ( n = 20 ) versus a timing and coordination of gait ( TC ) intervention ( n = 22 ) .
METHODS	Gain in gait speed after the intervention and its relation to callosal hyperintensities in the genu and splenium of the corpus callosum .
RESULTS	Gait speed improved in both the WEBS group ( mean change , 0.16 m/s ) and the TC group ( mean change , 0.21 m/s ; both P < .05 ) .
RESULTS	The volume of white matter hypertintensities ( WMHs ) in the genu was differentially associated with gait speed gain ( group genual WMH interaction , P = .05 ) .
RESULTS	Greater genual WMH volume was related to a smaller gait speed gain in the WEBS group ( P = .01 ) but not in the TC ( P = .10 ) group .
RESULTS	Splenial WMH volume was not differentially associated with gait speed gain ( interaction , P = .90 ) .
CONCLUSIONS	Callosal hyperintensities differentially influence gait speed gain by the type of gait rehabilitation .
CONCLUSIONS	Mobility impaired older adults with genual hyperintensities may benefit from a rehabilitation program focused on motor skill learning rather than on strength and endurance training .

###26295650
OBJECTIVE	The purpose of this study was to determine whether iterative reconstruction improves the quality of cranial CT ( CCT ) images of stroke patients .
METHODS	Fifty-one CCT studies of patients with infarction performed with either a low ( 260 mAs ; n = 21 ) or standard ( 340 mAs ; n = 30 ) dose were reconstructed with both filtered back projection ( FBP ) and sinogram-affirmed iterative reconstruction ( SAFIRE ) with five strength levels ( S1-S5 ) .
METHODS	The resulting six image sets ( one FBP and one each for SAFIRE levels S1-S5 ) were rated separately by two blinded radiologists in terms of conspicuity of infarcted areas on a 5-point scale .
METHODS	Noise and infarct-to-normal brain as well as medullary-to-cortical contrast-to-noise ratios ( CNRs ) were measured .
METHODS	Ratings , noise , and CNRs were intraindividually compared within the same dose group ( Fisher exact test ) and interindividually between the different dose groups ( Wilcoxon-Mann-Whitney U test ) .
RESULTS	The strength level S4 showed the best conspicuity of infarcted areas .
RESULTS	Compared with FBP , SAFIRE S4 statistically significantly ( p < 0.01 ) reduced noise and improved CNRs without statistically significant differences in all subjective and objective criteria ( p > 0.01 ) when the dose was reduced .
RESULTS	Patients examined with a 260-mAs low-dose were exposed to a statistically significantly lower dose ( 1.77 vs 2.33 mSv ; p < 0.01 ) .
CONCLUSIONS	Iterative reconstruction ( SAFIRE at strength level S4 ) leads to increased subjective and objective image quality in CCT and allows dose reduction ( -24 % ) without losses in the demarcation of ischemic lesions .

###24294677
BACKGROUND	After-hours telephone communications are common in patient management .
BACKGROUND	Patterns of communication of key information during after-hours phone calls were evaluated , and the utility of problem-specific Situation , Background , Assessment , Recommendation ( SBAR ) forms in improving this communication was assessed .
METHODS	In a randomized trial using a simulated on-call setting , 20 nurses called physicians regarding six cases adapted from inpatient records and based on the six most common reasons for after-hours nurse-physician communication .
METHODS	Three of the cases were handled without the SBAR forms ( control cases ) , and three cases were handled with the forms ( SBAR cases ) .
METHODS	Two cue types of communication were evaluated : situation cues , which conveyed the patient 's situation ( for example , a patient is confused ) , and background cues , which conveyed problem-specific data indicated on the SBAR forms ( for example , the patient has a low sodium level ) .
RESULTS	Ninety-two phone calls were analyzed ( 43 SBAR/49 controls ) .
RESULTS	Most of the nurses reported the situation cues ( SBAR 88 % , control 84 % , p = .60 ) but not the background cues .
RESULTS	There was a trend toward fewer background cues communicated in the SBAR cases ( 14 % versus 31 % , p = .08 ) .
RESULTS	In 14 % of the cases , on average , nurses omitted information or reported wrong information regarding the background cue .
RESULTS	Physicians asked questions that resulted in the communication of the cues in a minority of the cases when the background cues were not originally provided by the nurses ( SBAR 6 % , control 16 % , p = .39 ) .
CONCLUSIONS	In after-hours phone communication between physicians and nurses , significant information was often not communicated and physicians did not elicit the necessary information .
CONCLUSIONS	Simply providing an SBAR-based form did not ensure complete communication of key information .

###25731073
OBJECTIVE	The use of opioid analgesics in the United States has significantly increased in recent years .
OBJECTIVE	However , there is minimal consensus on what discharge counseling should accompany these high-risk prescriptions and large variations in what is done in practice .
OBJECTIVE	The objective of this study was to evaluate the effect of a dual-modality ( written and spoken ) literacy-appropriate educational strategy on patients ' knowledge of and safe use of opioid analgesics .
METHODS	This was a prospective , randomized controlled trial .
METHODS	Consecutive discharged patients at an urban academic ED ( > 88,000 visits ) with new prescriptions for hydrocodone-acetaminophen were enrolled .
METHODS	Patients were randomized to receive either usual care or the educational intervention .
METHODS	The educational intervention was a one-page information sheet about hydrocodone-acetaminophen , which was both given to the patients and read aloud by the research assistant ( nonblinded ) .
METHODS	Follow-up phone calls were conducted 4 to 7 days after the visit to assess patient knowledge about the medication and self-report of activities associated with safety of use ( e.g. , double-dipping with acetaminophen , storage , use with alcohol or while driving ) .
RESULTS	A total of 274 patients were enrolled ; 210 completed follow-up ( 110 usual care and 100 intervention ) .
RESULTS	No significant differences in baseline characteristics emerged between the study arms ; 42 % were male , and 51 % were white , with a median age of 43 years .
RESULTS	Half of patients had non-back pain orthopedic injuries ( 49.5 % ) .
RESULTS	On follow-up , overall knowledge was poor , with only 28 % able to name both active ingredients in the medication .
RESULTS	The intervention group had better knowledge of precautions related to taking additional acetaminophen ( usual care 18.2 % , 95 % confidence interval [ CI ] = 10.9 % to 25.5 % vs. intervention 38 % , 95 % CI = 28.3 % to 47.7 % ; difference = 27.6 , 95 % CI of difference = 21.5 to 33.7 ) and knowledge of side effects ( usual care median = 1 , interquartile range [ IQR ] 0 to 2 vs. intervention median = 2 , IQR = 1 to 2 ; p < 0.0001 ) .
RESULTS	Additionally , those who received the intervention were less likely to have reported driving within 6 hours after taking hydrocodone ( usual care 13.6 % , 95 % CI = 7.2 % to 20 % vs. intervention 3 % , 95 % CI = -0.3 % to 6.3 % ; difference = 10.6 , 95 % CI of difference = 3.4 to 17.9 ) .
RESULTS	There was no difference between groups related to knowledge about drinking alcohol while taking hydrocodone ( overall 18.1 % ) or knowledge that the opioid could be addictive ( overall 72.4 % ) .
CONCLUSIONS	This simple strategy improved several , but not all , aspects of patient knowledge and resulted in fewer patients in the intervention arm driving while taking hydrocodone .
CONCLUSIONS	Integration of a patient education document into conversations about opioids holds promise for improving patient knowledge about these high-risk medications .

###25372657
OBJECTIVE	Problem adaptation therapy ( PATH ) is a treatment for older adults with major depression , cognitive impairment ( from mild cognitive deficits to moderate dementia ) , and disability .
OBJECTIVE	Antidepressants have limited efficacy in this population and psychosocial interventions are inadequately investigated .
OBJECTIVE	To test the efficacy of 12-week PATH vs supportive therapy for cognitively impaired patients ( ST-CI ) in reducing depression and disability in 74 older adults with major depression , cognitive impairment , and disability .
METHODS	A randomized clinical trial at the Weill Cornell Institute of Geriatric Psychiatry from April 1 , 2006 , to September 31 , 2011 .
METHODS	Interventions were administered at the participants ' homes .
METHODS	Participants included 74 older individuals ( age 65 years ) with major depression and cognitive impairment to the level of moderate dementia .
METHODS	They were recruited through collaborating community agencies of Weill Cornell Institute of Geriatric Psychiatry and were randomly assigned to 12 weekly sessions of PATH or ST-CI ( 14.8 % attrition rate ) .
METHODS	Home-delivered PATH vs home-delivered ST-CI .
METHODS	Problem adaptation therapy integrates a problem-solving approach with compensatory strategies , environmental adaptations , and caregiver participation to improve patients ' emotion regulation .
METHODS	Supportive therapy for cognitively impaired patients focuses on expression of affect , understanding , and empathy .
METHODS	Mixed-effects models for longitudinal data compared the efficacy of PATH with that of ST-CI in reducing depression ( Montgomery-Asberg Depression Rating Scale ) and disability ( World Health Organization Disability Assessment Schedule II ) during 12 weeks of treatment .
RESULTS	Participants in PATH had significantly greater reduction in depression ( Cohen d , 0.60 ; 95 % CI , 0.13-1 .06 ; treatment time , F ( 1,179 ) = 8.03 ; P = .005 ) and disability ( Cohen d , 0.67 ; 95 % CI , 0.20-1 .14 ; treatment time , F ( 1,169 ) = 14.86 ; P = .001 ) than ST-CI participants during the 12-week period ( primary outcomes ) .
RESULTS	Furthermore , PATH participants had significantly greater depression remission rates than ST-CI participants ( 37.84 % vs 13.51 % ; ( 2 ) = 5.74 ; P = .02 ; number needed to treat = 4.11 ) ( secondary outcome ) .
CONCLUSIONS	Problem adaptation therapy was more efficacious than ST-CI in reducing depression and disability .
CONCLUSIONS	Problem adaptation therapy may provide relief to a large group of depressed and cognitively impaired older adults who have few treatment options .
BACKGROUND	Clinicaltrials.gov Identifier : NCT00368940 .

###24958479
OBJECTIVE	To examine the significant `` placebo effect '' in a randomized , double-blind , placebo-controlled interstitial cystitis/bladder pain syndrome trial .
OBJECTIVE	Randomized clinical trials are the reference standard for therapeutic impact assessment .
OBJECTIVE	However , proving efficacy of treatments for interstitial cystitis/bladder pain syndrome with rigorous placebo-controlled trials is difficult due to a significant effect of the placebo intervention .
METHODS	Interstitial cystitis/bladder pain syndrome patients were randomized to receive subcutaneous adalimumab or subcutaneous placebo every 2 weeks for 12 weeks and outcome measures were assessed .
RESULTS	Of the 43 patients , 21 received adalimumab and 22 received placebo .
RESULTS	Of the patients who received placebo , there was a statistically significant improvement demonstrated in the O'Leary-Sant Interstitial Cystitis Symptom and Problem Indexes of -8.1 ( 95 % confidence interval [ CI ] , 3.0-13 .2 ) , Interstitial Cystitis Symptom Index of -3.7 ( 95 % CI , 0.9-6 .5 ) , Interstitial Cystitis Problem Index of -4.4 ( 95 % CI , 2.0-6 .8 ) , and Pelvic Pain , Urgency , Frequency scale of -6.9 ( 95 % CI , 2.8-11 .0 ) at week 12 compared with baseline .
RESULTS	Most of the significantly improved placebo patients felt their improvement was because they were more conscientious about following physician advice and feeling less stress while in the study .
CONCLUSIONS	Patients with moderate to severe interstitial cystitis/bladder pain syndrome had significant improvement after receiving only advice and support .
CONCLUSIONS	This intervention is risk free and inexpensive .
CONCLUSIONS	Physicians should review standard advice with all interstitial cystitis/bladder pain syndrome patients before starting medical therapy .

###24382410
BACKGROUND	Restoring sinus rhythm in patients with heart failure ( HF ) and atrial fibrillation ( AF ) may improve left ventricular ( LV ) function and HF symptoms .
BACKGROUND	We sought to compare the effect of a catheter ablation strategy with that of a medical rate control strategy in patients with persistent AF and HF .
RESULTS	Patients with persistent AF , symptomatic HF , and LV ejection fraction < 50 % were randomized to catheter ablation or medical rate control .
RESULTS	The primary end-point was the difference between groups in LV ejection fraction at 6 months .
RESULTS	Baseline LV ejection fraction was 328 % in the ablation group and 3412 % in the medical group .
RESULTS	Twenty-six patients underwent catheter ablation , and 24 patients were rate controlled .
RESULTS	Freedom from AF was achieved in 21/26 ( 81 % ) at 6 months off antiarrhythmic drugs .
RESULTS	LV ejection fraction at 6 months in the ablation group was 4012 % compared with 3113 % in the rate control group ( P = 0.015 ) .
RESULTS	Ablation was associated with better peak oxygen consumption ( 226 versus 186 mL/kg per minute ; P = 0.014 ) and Minnesota living with HF questionnaire score ( 2422 versus 4722 ; P = 0.001 ) compared with rate control .
CONCLUSIONS	Catheter ablation is effective in restoring sinus rhythm in selected patients with persistent AF and HF , and can improve LV function , functional capacity , and HF symptoms compared with rate control .
CONCLUSIONS	Clinical Trial Registration - URL : http://www.clinicaltrials.gov .
CONCLUSIONS	Unique identifier : NCT01411371 .

###25608991
OBJECTIVE	To investigate the effect of letrozole in decreasing the early-stage ovarian hyperstimulation syndrome ( OHSS ) occurrence during the luteal phase for patients of OHSS high-risk after oocyte retrieval .
METHODS	A total of 176 high-risk OHSS patients were randomly divided into two groups after oocyte retrieval .
METHODS	Patients in experiment group ( n = 86 ) received 5 mg letrozole per day from the retrieval day and last for 5 days .
METHODS	Others in control group ( n = 90 ) received placebo .
METHODS	The serum concentration of FSH , LH , estradiol ( E2 ) , progesterone ( P ) and vascular endothelial growth factor ( VEGF ) from the day of hCG injection to days after injection ( 5 days , 8 days , 10 days ) were measured .
METHODS	And the incidence of moderate and severe OHSS was observed .
RESULTS	The concentration of E2 on the indicated days ( 5 days , 8 days , 10 days after hCG injection ) in experiment group and control group were ( 5 7272 089 ) versus ( 11 8264 281 ) pmol/L , ( 1 613879 ) versus ( 7 9253 507 ) pmol/L , ( 193 90 ) versus ( 1 628888 ) pmol/L ; the concentration of VEGF on the indicated days in the two groups were ( 8014 ) versus ( 10819 ) ng/L , ( 6611 ) versus ( 12614 ) ng/L , ( 487 ) versus ( 14814 ) ng/L ; the concentration of E2 and VEGF were lower than those in control group ( all P < 0.01 ) .
RESULTS	The FSH concentration in experiment group were ( 2.11.1 ) and ( 3.51.3 ) U/L on the day of fifth and eighth day after hCG injection , which were significantly higher than ( 0.70.3 ) and ( 0.70.4 ) U/L in control group ( P < 0.05 ) ; the LH concentration in experiment group were ( 0.260.19 ) and ( 0.720.60 ) U/L on the day of fifth and eighth day after hCG injection , which were significantly higher than ( 0.110.03 ) and ( 0.140.08 ) U/L in control group ( P < 0.05 ) .
RESULTS	The incidence of moderate and severe OHSS was signicantly decreased after letrozole treatment compared with control group [ 2 % ( 2/86 ) versus 12 % ( 11/90 ) , P < 0.05 ] .
CONCLUSIONS	Administration of 5 mg/d letrozole for 5 days during the luteal phase can reduce the E2 and VEGF levels for the high-risk OHSS patients who needed cryopreserve all embryos , and also reduce the occurrence of early OHSS .

###24819911
BACKGROUND	Combination therapy with acetylsalicylic acid and dipyridamole is first-line treatment in secondary prevention of strokes .
BACKGROUND	Approximately 40 % of patients report headache as a side effect of dipyridamole .
BACKGROUND	Dose escalation of dipyridamole reduces this side effect .
BACKGROUND	In practice , different dose escalation schemes are used .
BACKGROUND	In theory , slower dose escalation than a standard scheme reduces headaches even more .
BACKGROUND	This study aimed to find the best dose escalation scheme for prevention of headaches as a side effect of dipyridamole in the secondary prevention of strokes .
METHODS	In this randomized , open-label , 4-week trial , 114 patients who had an ischemic stroke or transient ischemic attack were randomized to receive either a standard or slow dose escalation scheme of dipyridamole .
METHODS	Participants were asked to report the four most common side effects of dipyridamole in a study diary on study days 1 , 3 , 5 , 7 , 14 , 21 and 28 .
METHODS	They were asked to score headache intensity on a visual analog scale ( VAS ) .
METHODS	Participants were unaware that the trial was focused on headaches .
METHODS	Primary end point was to determine if a slow dose escalation scheme reduces the percentage of patients with headaches .
METHODS	Secondary objective was to determine the number of patients who discontinued treatment with dipyridamole because of headaches .
RESULTS	Overall 37 patients ( 38 % ) of the final population reported headache , 19 ( 39 % ) in the standard dose escalation group and 18 ( 37 % ) in the slow dose escalation group ( p = 1.0 ) .
RESULTS	In the standard dose escalation group patients scored headaches ( VAS > 4 ) on an average of 3.3 days and patients in the slow dose escalation group on 3.6 days ( p = 0.82 ) .
RESULTS	Mean VAS scores on study days 1 , 3 , 5 , 7 , 14 and 21 ranged from 1.4 to 3.7 in both groups .
RESULTS	These scores did not differ significantly .
RESULTS	However , on day 28 patients scored a significantly lower mean VAS score in the standard dose escalation group than in the slow dose escalation group ( 2.5 vs. 4.8 ; p = 0.05 ) .
RESULTS	In the standard dose escalation group 6 patients ( 11 % ) discontinued treatment because of side effects of dipyridamole and 3 patients ( 6 % ) in the slow dose escalation group ( p = 0.49 , Fisher 's exact test ) .
CONCLUSIONS	We showed that slower than standard dose escalation of dipyridamole in combination therapy with acetylsalicylic acid does not reduce headaches as a side effect .
CONCLUSIONS	The use of such schemes should be discontinued in clinical practice .
CONCLUSIONS	Slow dose escalation might , however , reduce the number of patients who discontinue treatment , but further research is needed to confirm this .

###24708575
BACKGROUND	Despite major advances in transplant medicine , improvements in long-term kidney allograft survival have not been commensurate with those observed shortly after transplantation .
BACKGROUND	The formation of donor-specific antibodies ( DSA ) and ongoing antibody-mediated rejection ( AMR ) processes may critically contribute to late graft loss .
BACKGROUND	However , appropriate treatment for late AMR has not yet been defined .
BACKGROUND	There is accumulating evidence that the proteasome inhibitor bortezomib may substantially affect the function and integrity of alloantibody-secreting plasma cells .
BACKGROUND	The impact of this agent on the course of late AMR has not so far been systematically investigated .
METHODS	The BORTEJECT Study is a randomized controlled trial designed to clarify the impact of intravenous bortezomib on the course of late AMR .
METHODS	In this single-center study ( nephrological outpatient service , Medical University Vienna ) we plan an initial cross-sectional DSA screening of 1,000 kidney transplant recipients ( functioning graft at 180days ; estimated glomerular filtration rate ( eGFR ) > 20ml/minute/1 .73 m2 ) .
METHODS	DSA-positive recipients will be subjected to kidney allograft biopsy to detect morphological features consistent with AMR .
METHODS	Forty-four patients with biopsy-proven AMR will then be included in a double-blind placebo-controlled intervention trial ( 1:1 randomization stratified for eGFR and the presence of T-cell-mediated rejection ) .
METHODS	Patients in the active group will receive two cycles of bortezomib ( 41.3 mg/m2 over 2weeks ; 3-month interval between cycles ) .
METHODS	The primary end point will be the course of eGFR over 24months ( intention-to-treat analysis ) .
METHODS	The sample size was calculated according to the assumption of a 5ml/minute/1 .73 m2 difference in eGFR slope ( per year ) between the two groups ( alpha : 0.05 ; power : 0.8 ) .
METHODS	Secondary endpoints will be DSA levels , protein excretion , measured glomerular filtration rate , transplant and patient survival , and the development of acute and chronic morphological lesions in 24-month protocol biopsies .
CONCLUSIONS	The impact of anti-humoral treatment on the course of late AMR has not yet been systematically investigated .
CONCLUSIONS	Based on the hypothesis that proteasome inhibition improves the outcome of DSA-positive late AMR , we suggest that our trial has the potential to provide solid evidence towards the treatment of this type of rejection .
BACKGROUND	Clinicaltrials.gov : NCT01873157 .

###24375756
OBJECTIVE	To evaluate the effectiveness of daily tooth brushing with high-fluoride toothpaste on white spot lesion ( WSL ) formation in adolescents during treatment with fixed orthodontic appliances ( FOA ) .
METHODS	Four hundred and twenty-four healthy 11 - to 16-year-old patients , referred to five Orthodontic Specialist Clinics , were randomized to use either toothpaste containing 5000 ppm fluoride or regular toothpaste with 1450 ppm fluoride .
METHODS	To be eligible for inclusion , the patients had to be scheduled for bimaxillary treatment with FOA for an expected duration of at least 1 year .
METHODS	The primary and secondary outcome measures were prevalence and incidence of WSL , as registered from digital photos of the maxillary incisors , canines , and premolars taken before onset and immediately after debonding .
METHODS	The photos were evaluated separately by two blinded and calibrated clinicians using a 4-step score .
METHODS	A random sample of 50 cases was reassessed to check intra - and interexaminer reliability ( Kappa = 0.70 ; 0.74 ) .
RESULTS	The use of high-fluoride toothpaste resulted in fewer WSL ( P = 0.042 ) with a prevented fraction of 32 % .
RESULTS	The lateral incisor was most commonly affected in both groups .
CONCLUSIONS	To prevent WSL during treatment of FOA , daily use of high-fluoride toothpaste may be recommended .

###24695888
BACKGROUND	Sensory properties of foods promote and guide consumption in hunger states , whereas satiation should dampen the sensory activation of ingestive behaviors .
BACKGROUND	Such activation may be disordered in obese individuals .
OBJECTIVE	Using functional magnetic resonance imaging ( fMRI ) , we studied regional brain responses to food odor stimulation in the sated state in obese and normal-weight individuals targeting ventral frontal regions known to be involved in coding for stimulus reward value .
METHODS	Forty-eight women ( 25 normal weight ; 23 obese ) participated in a 2-day ( fed compared with fasting ) fMRI study while smelling odors of 2 foods and an inedible , nonfood object .
METHODS	Analyses were conducted to permit an examination of both general and sensory-specific satiation ( satiation effects specific to a given food ) .
RESULTS	Normal-weight subjects showed significant blood oxygen level-dependent responses in the ventromedial prefrontal cortex ( vmPFC ) to food aromas compared with responses induced by the odor of an inedible object .
RESULTS	Normal-weight subjects also showed general ( but not sensory-specific ) satiation effects in both the vmPFC and orbitofrontal cortex .
RESULTS	Obese subjects showed no differential response to the aromas of food and the inedible object when fasting .
RESULTS	Within - and between-group differences in satiation were driven largely by changes in the response to the odor of the inedible stimulus .
RESULTS	Responses to food aromas in the obese correlated with trait negative urgency , the tendency toward negative affect-provoked impulsivity .
CONCLUSIONS	Ventral frontal signaling of reward value may be disordered in obesity , with negative urgency heightening responses to food aromas .
CONCLUSIONS	The observed nature of responses to food and nonfood stimuli suggests that future research should independently quantify each to fully understand brain reward signaling in obesity .

###24608457
OBJECTIVE	The objective of the following study is to determine the effect of continuous insonation using 2-MHz transcranial Doppler-ultrasound ( TCD-US ) on the recanalization rate and the short-term outcome in subjects with acute ischemic stroke due to middle cerebral artery ( MCA ) occlusion .
METHODS	A total of 42 patients with acute ischemic stroke due to MCA occlusion within 24 h were recruited and randomly allotted to two groups ( 21 patients in each group ) .
METHODS	Group 1 included patients who received 1 h continuous TCD-US for MCA and Group 2 included patients who did not receive 1 h continuous TCD-US .
METHODS	Patients in both groups were received MCA insonation and TCD study to measure mean flow velocity ( MFV ) in MCA one after the initial study at 20 and 60 min .
METHODS	All patients received aspirin ( 150-325 mg ) .
METHODS	The clinical course during hospital stay was assessed before and after 1 h of US insonation , at 24 h after symptom onset using the National Institutes of Health Stroke Scale .
RESULTS	Change in MFV after insonation for Group 1 in comparison to Group 2 at 3 time points was significantly high ( P < 0.001 ) .
CONCLUSIONS	Sonothrombolysis is a therapeutic option to improve the outcomes in patients with acute ischemic stroke due to MCA occlusion .

###24642984
BACKGROUND	Unsatisfactory colposcopy , an inability to visualize the entire transformation zone , is found in about 10-20 % of the patients undergoing the procedure .
BACKGROUND	These patients usually require conization for a comprehensive evaluation of the cervix .
BACKGROUND	Our study aims to compare the efficacy and safety of vaginal misoprostol versus vaginal estradiol in overcoming unsatisfactory colposcopy .
METHODS	We studied 48 women with unsatisfactory colposcopy .
METHODS	They were randomized into two groups : group I ( n = 24 ) received 200 g misoprostol vaginally and colposcopy was repeated after 6 h , while the subjects in group II ( n = 24 ) were prescribed a 7-day course of 50 g estradiol for vaginal insertion followed by a repeat colposcopy .
METHODS	The efficacy and safety of these two drugs were compared .
RESULTS	Repeat colposcopy was satisfactory in 70.8 % of the women given vaginal misoprostol compared to 82.6 % of the women who used vaginal estradiol .
RESULTS	The difference was not statistically significant .
RESULTS	The adverse effects were reported more often by the women in the misoprostol group ( 41.6 % ) as compared to those in estradiol group ( 13 % ) ( p = 0.04 ) .
CONCLUSIONS	Both estradiol and misoprostol were comparable in overcoming unsatisfactory colposcopy .
CONCLUSIONS	However , a higher incidence of adverse effects was noted with misoprostol as compared to estradiol .

###24846652
BACKGROUND	Thymic stromal lymphopoietin ( TSLP ) is an epithelial-cell-derived cytokine that may be important in initiating allergic inflammation .
BACKGROUND	AMG 157 is a human anti-TSLP monoclonal immunoglobulin G2 that binds human TSLP and prevents receptor interaction .
METHODS	In this double-blind , placebo-controlled study , we randomly assigned 31 patients with mild allergic asthma to receive three monthly doses of AMG 157 ( 700 mg ) or placebo intravenously .
METHODS	We conducted allergen challenges on days 42 and 84 to evaluate the effect of AMG 157 in reducing the maximum percentage decrease in the forced expiratory volume in 1 second ( FEV1 ) .
METHODS	We also measured the fraction of nitric oxide in exhaled air , blood and sputum eosinophils , and airway hyperresponsiveness .
METHODS	The primary end point was the late asthmatic response , as measured 3 to 7 hours after the allergen challenge .
RESULTS	AMG 157 attenuated most measures of allergen-induced early and late asthmatic responses .
RESULTS	The maximum percentage decrease in the FEV1 during the late response was 34.0 % smaller in the AMG-157 group than in the placebo group on day 42 ( P = 0.09 ) and 45.9 % smaller on day 84 ( P = 0.02 ) .
RESULTS	In addition , patients receiving AMG 157 had significant decreases in levels of blood and sputum eosinophils before and after the allergen challenge and in the fraction of exhaled nitric oxide .
RESULTS	There were 15 adverse events in the AMG-157 group , as compared with 12 in the placebo group ; there were no serious adverse events .
CONCLUSIONS	Treatment with AMG 157 reduced allergen-induced bronchoconstriction and indexes of airway inflammation before and after allergen challenge .
CONCLUSIONS	These findings are consistent with a key role for TSLP in allergen-induced airway responses and persistent airway inflammation in patients with allergic asthma .
CONCLUSIONS	Whether anti-TSLP therapeutics will have clinical value can not be determined from these data .
CONCLUSIONS	( Funded by Amgen ; ClinicalTrials.gov number , NCT01405963 . )

###24556493
OBJECTIVE	This study evaluated the effect of probiotic intervention using lactobacilli on oral malodor .
METHODS	We conducted a 14-day , double-blind , placebo-controlled , randomized crossover trial of tablets containing Lactobacillus salivarius WB21 ( 2.0 10 ( 9 ) colony-forming units per day ) or placebo taken orally by patients with oral malodor .
RESULTS	Organoleptic test scores significantly decreased in both the probiotic and placebo periods compared with the respective baseline scores ( P < .001 and P = .002 ) , and no difference was detected between periods .
RESULTS	In contrast , the concentration of volatile sulfur compounds ( VSCs ) ( P = .019 ) and the average probing pocket depth ( P = .001 ) decreased significantly in the probiotic period compared with the placebo period .
RESULTS	Bacterial quantitative analysis found significantly lower levels of ubiquitous bacteria ( P = .003 ) and Fusobacterium nucleatum ( P = .020 ) in the probiotic period .
CONCLUSIONS	These results indicated that daily oral consumption of tablets containing probiotic lactobacilli could help to control oral malodor and malodor-related factors .

###26087637
OBJECTIVE	To elucidate the safety profile and symptom-modifying effect of Alflutop and diacerein in the treatment of Kellgren-Lawrence Stages II-III knee osteoarthrosis ( OA ) in patients with oxalate nephropathy and Stages I-II chronic kidney disease ( CKD ) and to refine the effect of these drugs on urinary syndrome and renal function as compared to a response to nonsteroidal anti-inflammatory drugs -- cyclooxygenase inhibitors ( diclofenac ) .
METHODS	This open-label comparative randomized trial enrolled 86 female patients with Kellgren-Lawrence Stages II-III primary gonarthritis concurrent with oxalate nephropathy and Stages I-II CKD .
METHODS	The patients were randomized into 3 groups : 1 ) 20 patients took diclofenac sodium 100 mg/day ; 2 ) 30 received a complex pharmaceutical on the basis of glycozaminoglycans Alflutop injection 1 ml per day for 20 days , then 2 ml intraartricular twice weekly in the following month ; 3 ) 36 had diacerein ( diaflex , `` Rompharm Company '' ) in a dose of 50 mg twice daily for 3 months .
METHODS	On day 30 and day 90 of treatment , the symptom - modifying effect was evaluated from changes in the joint pain and morning stiffness domains of the WOMAC index .
METHODS	Renal function was measured using the estimated glomerular filtration rate ( GFR ) , uric acid clearance ( C ( ua ) ) , and urinary sediment .
RESULTS	On day 30 of treatment , the patients taking diclofenac were found to have nephrotoxic effects ( lower GFR , C ( ua ) , evolving secondary hyperuricemia , progressive proteinuria , emerging microhematuria , elevated urinary levels of total lipid hydroperoxides , and enhanced calcium oxalate crystalluria ) .
RESULTS	Alflutop and diacerein exerted no negative effects on renal function .
RESULTS	On day 30 day of treatment , all the patient groups showed a reduction in the WOMAC pain score .
RESULTS	The diclofenac group displayed a more marked decrease in the pain score than did the two other groups by day 30 .
RESULTS	Otherwise by day 90 of therapy with Alflutop and diacerein , the pain scores were reduced by 60 and 67 % , respectively , which was similar to those in the diclofenac group by day 30 of a follow-up .
RESULTS	By day 30 day of treatment , the stiffness score was also observed to fall in all the groups and achieved even lower values in the Alflutop and diacerein groups compared with diclofenac group .
CONCLUSIONS	Alflutop and diacerein used by patients with knee OA do not produce nephrotoxic effects and by day 90 demonstrated similar to diclofenac symptom-modifying effect by reducing pain and stiffness scores .
CONCLUSIONS	Diclofenac administration contributed to oxalate nephropathy progress .

###24908523
BACKGROUND	Cesarean section is one of the most commonly performed operations in most countries of the world including Nepal .
BACKGROUND	Hence there is a load on the financial resources of healthcare system .
BACKGROUND	The rational of this study was to utilize the remaining No ' 1 ' polyfilament after closing rectus sheath to stitch skin .
BACKGROUND	So , the primary objective was to determine the wound complication rates for subcuticular suture with No ' 1 ' petcryl ( polyfilamentpolyglycolic acid ) Vs intermittent suture with nylon 2-0 for skin closure at cesarean delivery and secondary objective was to compare postoperative pain and patient satisfaction about the scar .
METHODS	One hundred and thirty eight women undergoing cesarean section at Chitwan Medical College was randomized to either intermittent skin suture with nylon 2-0 or subcuticular with polyfilament No ' 1 ' ( remaining suture after closing rectus sheath ) .
METHODS	Evidence of wound infection , pain and overall satisfaction were assessed postoperatively .
RESULTS	The overall wound complications rate in subcuticular stitch with No ' 1 ' polyfilament suture were similar as in intermittent mattress stitch with nylon 2-0 ( 15.9 % vs. 14.49 % ) .
RESULTS	Pain on postoperative third day and six weeks and overall satisfaction about wound were similar in both groups .
RESULTS	Only prolong rupture of membrane > 18 hours was found to be a significant risk factor of wound infection ( OR : 3.4 ; p = 0.04 ) .
CONCLUSIONS	The remaining no ' 1 ' polyfilament suture ( petcryl ) after suturing rectus sheath can be safely used to close skin suture in cesarean section .

###24762111
BACKGROUND	Failure of aldosterone suppression by sodium loading during fludrocortisone suppression testing ( FST ) or saline suppression testing ( SST ) confirms primary aldosteronism ( PA ) .
BACKGROUND	We previously found recumbent SST ( RSST ) to lack sensitivity .
BACKGROUND	Aldosterone levels can be higher upright ( e.g. seated ) than recumbent in patients with PA and upright levels are used during FST .
BACKGROUND	We therefore hypothesized that seated SST ( SSST ) is more sensitive than RSST , especially for posture-responsive PA. .
METHODS	Of 66 patients who underwent FST ( upright plasma aldosterone levels measured at 10am basally and after 4 days fludrocortisone 0.1 mg 6-hourly and oral salt loading ) , 31 underwent SST ( aldosterone levels measured basally at 8am and after infusion of 2 L normal saline over 4h ) both recumbent and seated in randomized order and at least 2 weeks apart .
RESULTS	FST confirmed PA in 23 of 31 patients ( day 4 upright aldosterone level > 165 pmol/L ) , excluded PA in three and was originally `` inconclusive '' in five .
RESULTS	However , one with `` inconclusive '' FST had PA confirmed by lateralizing AVS and was reclassified `` unilateral PA '' .
RESULTS	Of 24 with confirmed PA ( eight unilateral , 11 bilateral , and five undetermined subtype ) , 23 ( 96 % ) tested positive by SSST ( 4-h aldosterone level > 165 pmol/L ) compared with 8 ( 33 % ) by RSST ( 4-h plasma aldosterone level > 140 pmol/L ) ( P < .001 ) .
RESULTS	RSST missed one unilateral , all bilateral , and four with as-yet undetermined subtype .
RESULTS	RSST was positive in 7 of 10 ( 70 % ) posture-unresponsive vs one of 14 ( 7.1 % ) posture-responsive patients ( P < .005 ) .
CONCLUSIONS	These preliminary results suggest that seated SST may be superior to recumbent SST in terms of sensitivity for detecting PA , especially posture-responsive forms , and may represent a reliable alternative to FST .

###24698199
BACKGROUND	Intensive hemodialysis ( HD ) may have significant benefits .
BACKGROUND	Recently , the role of extended hemodiafiltration ( HDF ) has gained interest .
BACKGROUND	The aim of this study was to evaluate the acute effects of extended HD and HDF on hemodynamic response and solute removal .
METHODS	Randomized crossover trial .
METHODS	Stable patients with end-stage renal disease undergoing conventional HD .
METHODS	13 patients randomly completed a single study of 4-hour HD ( HD4 ) , 4-hour HDF ( HDF4 ) , 8-hour HD ( HD8 ) , and 8-hour HDF ( HDF8 ) , with a 2-week interval between study sessions .
METHODS	Between study sessions , patients received routine conventional HD treatments .
RESULTS	Acute hemodynamic effects and uremic toxin clearance .
METHODS	Blood pressure and heart rate , pulse wave analysis , cardiac output , and microvascular density by sublingual capillaroscopy , as well as relative blood volume and thermal variables , were measured .
METHODS	Clearance and removal of uremic toxins also were studied .
RESULTS	Long treatments showed more stability of peripheral systolic blood pressure ( change during HD4 , -21.715.6 mm Hg ; during HDF4 , -23.320.8 mm Hg ; during HD8 , -6.715.2 mm Hg [ P = 0.04 vs. HD4 ; P = 0.08 vs. HDF4 ] ; and during HDF8 , -0.514.4 mm Hg [ P = 0.004 vs. HD4 ; P = 0.008 vs. HDF4 ] ) .
RESULTS	A similar observation was found for peripheral diastolic and central blood pressures .
RESULTS	Cardiac output remained more stable in extended sessions ( change during HD4 , -1.41.5 L/min ; during HDF4 , -1.61.0 L/min ; during HD8 , -0.40.9 L/min [ P = 0.02 vs. HDF4 ] ; and during HDF8 , -0.50.8 L/min [ P = 0.06 vs. HD4 ; P = 0.03 vs. HDF4 ) , in line with the decreased relative blood volume slope in long dialysis .
RESULTS	No differences in microvascular density were found .
RESULTS	Energy transfer rates were comparable ( HD4 , 13.34.7 W ; HDF4 , 16.25.6 W ; HD8 , 14.26.0 W ; and HDF8 , 14.54.3 W ) .
RESULTS	Small-molecule and phosphate removal were superior during long treatments .
RESULTS	2-Microglobulin and fibroblast growth factor 23 ( FGF-23 ) reduction ratios were highest in HDF8 .
CONCLUSIONS	Small sample size , only acute effects were studied .
CONCLUSIONS	Treatment time , and not modality , was the determinant for the hemodynamic response .
CONCLUSIONS	HDF significantly improved removal of middle molecules , with superior results in extended HDF .

###24661464
BACKGROUND	Enhancing the reliability and responsiveness of motor assessments required to demonstrate therapeutic efficacy is a priority for Parkinson 's disease ( PD ) clinical trials .
BACKGROUND	The objective of this study is to determine the reliability and responsiveness of a portable kinematic system for quantifying PD motor deficits as compared to clinical ratings .
METHODS	Eighteen PD patients with subthalamic nucleus deep-brain stimulation ( DBS ) performed three tasks for evaluating resting tremor , postural tremor , and finger-tapping speed , amplitude , and rhythm while wearing a wireless motion-sensor unit ( Kinesia ) on the more-affected index finger .
METHODS	These tasks were repeated three times with DBS turned off and at each of 10 different stimulation amplitudes chosen to yield small changes in treatment response .
METHODS	Each task performance was video-recorded for subsequent clinician rating in blinded , randomized order .
METHODS	Test-retest reliability was calculated as intraclass correlation ( ICC ) and sensitivity was calculated as minimal detectable change ( MDC ) for each DBS amplitude .
RESULTS	ICCs for Kinesia were significantly higher than those for clinician ratings of finger-tapping speed ( p < 0.0001 ) , amplitude ( p < 0.0001 ) , and rhythm ( p < 0.05 ) , but were not significantly different for evaluations of resting or postural tremor .
RESULTS	Similarly , Kinesia scores yielded a lower MDC as compared with clinician scores across all finger-tapping subscores ( p < 0.0001 ) , but did not differ significantly for resting and postural tremor .
CONCLUSIONS	The Kinesia portable kinematic system can provide greater test-retest reliability and sensitivity to change than conventional clinical ratings for measuring bradykinesia , hypokinesia , and dysrhythmia in PD patients .

###25087308
OBJECTIVE	To evaluate the sedative effects , intra-operation , of music therapy in orthopedic surgery patients with locoregional anesthesia in the Hospital Clnic i Provincial of Barcelona .
METHODS	Prospective comparative study on a random sample of 110 patients undergoing or not music therapy .
METHODS	The degree of anxiety was assessed with the Questionnaire STAIC .
METHODS	The application of the music was done with a MP3 player and headphones .
METHODS	The collected data were analyzed with Excel .
METHODS	For the statistical analysis we used the SPSS-18 software and Chi-square test to test the hypothesis of whether there was relationship between the level of peace and music therapy .
RESULTS	After the analysis , the results of Chi-square were in the group of no sedation with/without music Chi2 = 2.01 , P = 0.35 .
RESULTS	The statistical significance level was p < 0.05 .
CONCLUSIONS	No relationship was found between hearing music or not and the patient 's comfort level .
CONCLUSIONS	Most patients recommend listening to music in the operating room despite the sounds around do not bother them .

###25315942
OBJECTIVE	To investigate the effects of - blockers on cardiac protection and hemodynamic in patients with septic shock .
METHODS	A prospective randomized controlled trial was conducted .
METHODS	Forty-one patients with septic shock in accordance with early goal directed treatment and met the target within 6 hours , and admitted to intensive care unit ( ICU ) of Affiliated Huxi Hospital of Jining Medical College from January 2012 to January 2014 were enrolled .
METHODS	The patients were divided into treatment group ( n = 21 ) and control group ( n = 20 ) by random number table .
METHODS	The patients in both groups were given the standard treatment , esmolol was giving to patients in treatment group in order to control the heart rate ( HR ) below 100 bpm within 2 hours , and the patients in control group only received standard treatment .
METHODS	The changes in hemodynamic parameters [ mean arterial pressure ( MAP ) , central venous pressure ( CVP ) , HR , cardiac index ( CI ) , stroke volume index ( SVI ) , systemic vascular resistance ( SVRI ) , global end diastolic volume index ( GEDVI ) ] , biochemistry metabolic of tissue [ central venous oxygen saturation ( ScvO ) , lactic acid ( Lac ) ] , and cardiac markers [ troponin I ( cTnI ) ] before and 12 , 24 , 48 , 72 hours after the treatment were recorded .
RESULTS	( 1 ) Before treatment , the hemodynamic parameters , tissue metabolism index and cTnI had no significant differences in both groups ( all P > 0.05 ) .
RESULTS	( 2 ) The hemodynamic parameters after treatment in the control group showed no significant difference compared with that before treatment .
RESULTS	HR and CI in the treatment group were gradually declined after treatment , SVRI and GEDVI were gradually increased .
RESULTS	There were significant differences in HR , CI , SVRI , and GEDVI between treatment group and control group from 12 hours on [ HR ( bpm ) : 93 4 vs. 118 13 , CI ( L min m ) : 3.3 0.8 vs. 4.5 0.6 , SVRI ( kPas L m ) : 159.2 27.4 vs. 130.5 24.2 , GEDVI ( mL/m ) : 668 148 vs. 588 103 , P < 0.05 or P < 0.01 ] .
RESULTS	MAP , CVP and SVI in the treatment group showed no significant changes .
RESULTS	( 3 ) Lac after treatment in both groups was decreased slowly , Lac ( mmol/L ) at 12 hours after treatment was significantly decreased compared with that before treatment ( control group : 8.8 3.2 vs. 9.8 3.4 , treatment group : 9.5 3.1 vs. 10.5 4.1 , both P < 0.05 ) .
RESULTS	The Lac of control group and treatment group were 2.5 1.2 and 2.7 1.1 at 72 hours after treatment , and there was no significant difference between two groups ( all P > 0.05 ) .
RESULTS	The ScvOwas not decreased in both groups .
RESULTS	( 4 ) Compared with before treatment , cTnI in the control group was gradually increased , peaked at 72 hours , and that in the treatment group was gradually increased , peaked at 24 hours and then gradually declined .
RESULTS	Compared with control group , the cTnI ( g/L ) in the treatment group was decreased significantly at 24 , 48 , 72 hours ( 1.15 0.57 vs. 1.74 0.77 , 0.93 0.52 vs. 2.15 1.23 , 0.52 0.36 vs. 2.39 1.17 , all P < 0.01 ) .
CONCLUSIONS	- blockers ( esmolol ) can improve cardiac function and myocardial compliance , reduce the myocardial injury in patients with sepsis shock .
CONCLUSIONS	Although - blockers can decrease cardiac output , it has no influence on the circulation function and tissue perfusion .

###24835503
BACKGROUND	Eosinophilic esophagitis ( EoE ) is a chronic antigen-mediated disease characterized by esophageal eosinophilia , remodeling , and fibrosis .
BACKGROUND	TGF-1 is a central regulator of EoE remodeling and increases esophageal smooth muscle ( ESM ) cell contraction .
OBJECTIVE	In this study we aimed to understand the molecular mechanisms by which TGF-1 could induce ESM cell contraction .
METHODS	We used primary human ESM cells and esophageal myofibroblasts ( EMFs ) to assess the mechanisms of TGF-1-induced contraction .
METHODS	We analyzed the expression , phosphorylation , and function of phospholamban ( PLN ) , a sarcoendoplasmic reticulum regulatory protein induced by TGF-1 .
METHODS	Expression of PLN , phospho-PLN , and its regulatory pathway was analyzed in the ESM of biopsy specimens from patients with EoE and control subjects .
METHODS	Gene silencing in EMFs from patients with EoE was used to understand the role of PLN in contraction .
RESULTS	TGF-1 induced and phosphorylated PLN in primary human ESM cells and EMFs from patients with EoE .
RESULTS	PLN and phospho-PLN levels were increased in smooth muscle from patients with EoE compared with that seen in smooth muscle from control subjects in vivo .
RESULTS	PLN inhibition significantly diminished TGF-1-induced EMF contraction in patients with EoE .
RESULTS	PLN expression and ESM/EMF contraction depended on TGF - receptor I signals .
CONCLUSIONS	We describe a previously unrecognized mechanism for ESM cell contraction that depends on TGF-1 , its receptors , and PLN .
CONCLUSIONS	Because PLN levels are increased in smooth muscle from patients with EoE and PLN silencing diminishes contraction , we provide a novel potential mechanistic framework and therapeutic target for ESM dysfunction in patients with EoE .

###24754530
OBJECTIVE	To characterize the physiologic and behavioral effects of a single induction dose and two maintenance doses of alfaxalone delivered by water immersion in the anesthesia of koi ( Cyprinus carpio ) .
METHODS	Prospective , within-subject complete crossover design .
METHODS	Six adult koi ( Cyprinus carpio ) with a median body weight of 344.5 g ( range 292.0-405 .0 g ) .
METHODS	Koi were immersed in water containing 10 mg L ( -1 ) alfaxalone until immobile and then maintained with alfaxalone at either 1 or 2.5 mg L ( -1 ) via a recirculating water system .
METHODS	Times for anesthetic induction and recovery periods were recorded .
METHODS	Physiologic and blood gas parameters were evaluated before , during and after the anesthetic trial .
METHODS	Response to noxious stimuli was also assessed .
RESULTS	Median anesthesia induction time for all fish was 5.4 minutes .
RESULTS	Median recovery time was 11.8 and 26.4 minutes in the 1.0 and 2.5 mg L ( -1 ) doses , respectively , which were significantly different ( p = 0.04 ) .
RESULTS	Cessation of opercular movement occurred in 0/6 and 4/6 fish exposed to 1.0 and 2.5 mg L ( -1 ) dose respectively .
RESULTS	No difference was observed in median heart rate over the duration of the anesthetic events .
RESULTS	Response to noxious stimulation was 4/6 and 0/6 in the 1.0 and 2.5 mg L ( -1 ) doses respectively .
RESULTS	Oxygenation and ventilation did not change during the experiment , but there was a significant decrease in blood pH along with an increase in blood lactate concentration .
CONCLUSIONS	Administration of alfaxalone , via water immersion , as an induction and maintenance anesthesia agent provided rapid and reliable anesthesia of koi with no mortality .
CONCLUSIONS	The maintenance dose of 2.5 mg L ( -1 ) was sufficient to prevent response to noxious stimuli but was associated with a clinically relevant depression in opercular rate .

###24908099
BACKGROUND	Randomised trials provide evidence that patient decision aids improve outcomes with respect to patient knowledge , involvement and satisfaction in decision making .
BACKGROUND	It is less clear how these complex interventions are implemented within patient-clinician interactions and which components are active for improving decision processes .
BACKGROUND	To investigate the experiences of using a diabetes treatment decision aid and to explore how components within a complex intervention influenced the decision making process .
METHODS	A pragmatic mixed methods study nested within the PANDAs cluster randomised trial of a patient decision aid .
METHODS	Themes inductively derived from interviews and observation of consultations with further triangulation with results of decision quality and involvement measurements and case analyses .
RESULTS	The decision aid intervention was employed flexibly within the consultation with both the patient and clinician active in marshalling elements .
RESULTS	The decision aid improved processing and organization of information needed for decision making within the consultation interaction .
RESULTS	It also improved decision quality by preparing the patient for active involvement within the clinical consultation .
CONCLUSIONS	The intervention was acceptable , flexible and readily implemented in primary care consultations .
CONCLUSIONS	The decision aid was effective in facilitating cognitive processing .
CONCLUSIONS	The intervention also facilitated rehearsal in preparation for active roles in a shared decision process .
BACKGROUND	Trials Register Number : ISRCTN14842077 .
BACKGROUND	Date registered : 24.06.2010 .

###25211372
BACKGROUND	Individuals with posttraumatic stress disorder ( PTSD ) often exhibit high-risk substance use behaviors .
BACKGROUND	Complementary and alternative therapies are increasingly used for mental health disorders , although evidence is sparse .
OBJECTIVE	Investigate the effect of a yoga intervention on alcohol and drug abuse behaviors in women with PTSD .
OBJECTIVE	Secondary outcomes include changes in PTSD symptom perception and management and initiation of evidence-based therapies .
METHODS	The current investigation analyzed data from a pilot randomized controlled trial comparing a 12-session yoga intervention with an assessment control for women age 18 to 65 years with PTSD .
METHODS	The Alcohol Use Disorder Identification Test ( AUDIT ) and Drug Use Disorder Identification Test ( DUDIT ) were administered at baseline , after the intervention , and a 1-month follow-up .
METHODS	Linear mixed models were used to test the significance of the change in AUDIT and DUDIT scores over time .
METHODS	Treatment-seeking questions were compared by using Fisher exact tests .
RESULTS	The mean AUDIT and DUDIT scores decreased in the yoga group ; in the control group , mean AUDIT score increased while mean DUDIT score remained stable .
RESULTS	In the linear mixed models , the change in AUDIT and DUDIT scores over time did not differ significantly by group .
RESULTS	Most yoga group participants reported a reduction in symptoms and improved symptom management .
RESULTS	All participants expressed interest in psychotherapy for PTSD , although only two participants , both in the yoga group , initiated therapy .
CONCLUSIONS	Results from this pilot study suggest that a specialized yoga therapy may play a role in attenuating the symptoms of PTSD , reducing risk of alcohol and drug use , and promoting interest in evidence-based psychotherapy .
CONCLUSIONS	Further research is needed to confirm and evaluate the strength of these effects .

###24352414
OBJECTIVE	The aim of the study is to evaluate the long-term near-transfer effects of computerized working memory ( WM ) training on standard WM tasks in children with Attention-Deficit/Hyperactivity Disorder ( ADHD ) .
METHODS	Sixty-seven children aged 10-12 years in Vestfold/Telemark counties ( Norway ) diagnosed with F90 .0 Hyperkinetic disorder ( ICD-10 ) were randomly assigned to training or control group .
METHODS	The training group participated in a 25-day training program at school , while the control group received treatment-as-usual .
METHODS	Participants were tested one week before intervention , immediately after and eight months later .
METHODS	Based on a component analysis , six measures of WM were grouped into composites representing Visual , Auditory and Manipulation WM.
RESULTS	The training group had significant long-term differential gains compared to the control group on all outcome measures .
RESULTS	Performance gains for the training group were significantly higher in the visual domain than in the auditory domain .
RESULTS	The differential gain in Manipulation WM persisted after controlling for an increase in simple storage capacity .
CONCLUSIONS	Systematic training resulted in a long-term positive gain in performance on similar tasks , indicating the viability of training interventions for children with ADHD .
CONCLUSIONS	The results provide evidence for both domain-general and domain-specific models .
CONCLUSIONS	Far-transfer effects were not investigated in this article .
BACKGROUND	Controlled-Trials .
BACKGROUND	com ISRCTN19133620 .

###24411428
OBJECTIVE	A number of simulators have been developed to teach surgical trainees the basic skills required to effectively perform laparoscopic surgery ; however , consideration needs to be given to how well the skills taught by these simulators are maintained over time .
OBJECTIVE	This study compared the maintenance of laparoscopic skills learned using box trainer and virtual reality simulators .
METHODS	Participants were randomly allocated to be trained and assessed using either the Society of American Gastrointestinal Endoscopic Surgeons Fundamentals of Laparoscopic Surgery ( FLS ) simulator or the Surgical Science virtual reality simulator .
METHODS	Once participants achieved a predetermined level of proficiency , they were assessed 1 , 3 , and 6 months later .
METHODS	At each assessment , participants were given 2 practice attempts and assessed on their third attempt .
METHODS	The study was conducted through the Simulated Surgical Skills Program that was held at the Royal Australasian College of Surgeons , Adelaide , Australia .
RESULTS	Overall , 26 participants ( 13 per group ) completed the training and all follow-up assessments .
RESULTS	There were no significant differences between simulation-trained cohorts for age , gender , training level , and the number of surgeries previously performed , observed , or assisted .
RESULTS	Scores for the FLS-trained participants did not significantly change over the follow-up period .
RESULTS	Scores for LapSim-trained participants significantly deteriorated at the first 2 follow-up points ( 1 and 3 months ) ( p < 0.050 ) , but returned to be near initial levels by the final follow-up ( 6 months ) .
CONCLUSIONS	This research showed that basic laparoscopic skills learned using the FLS simulator were maintained more consistently than those learned on the LapSim simulator .
CONCLUSIONS	However , by the final follow-up , both simulator-trained cohorts had skill levels that were not significantly different to those at proficiency after the initial training period .

###24959734
OBJECTIVE	To compare the effects of 2 NSAIDs ( phenylbutazone and meloxicam ) on renal function in horses .
METHODS	9 Thoroughbred or Standardbred mares ( mean SD age , 5.22 1.09 years [ range , 2 to 12 years ] ; mean body weight , 470 25 kg [ range , 442 to 510 kg ] ) .
METHODS	A randomized blinded placebo-controlled crossover study was conducted to examine the effects of treatment with phenylbutazone , meloxicam , or a placebo ( control solution ) on renal responses to the administration of furosemide , dobutamine , and exercise ( 15 minutes at 60 % of maximum heart rate ) .
METHODS	Renal function was assessed by use of bilateral ureteral catheterization for simultaneous determination of creatinine clearance , sodium excretion , and urine flow rate .
RESULTS	Both phenylbutazone and meloxicam attenuated diuresis and natriuresis and reduced glomerular filtration rate , compared with results for the control solution , when horses were treated with furosemide .
RESULTS	Mean arterial blood pressure , urine flow rate , and glomerular filtration rate were increased during or after ( or both ) dobutamine infusion .
RESULTS	Both NSAIDs reduced urine flow rate and sodium excretion associated with dobutamine infusion and exercise but had no effect on glomerular filtration rate .
CONCLUSIONS	Responses to meloxicam , a cyclooxygenase ( COX ) -2 preferential agent , appeared comparable to those detected after phenylbutazone treatment , which suggested that COX-2 was the mediator of prostanoid-induced changes to renal function in horses and indicated that COX-2-preferential agents would be likely to have adverse renal effects similar to those for nonselective COX inhibitors in volume-depleted horses .

###25293387
BACKGROUND	Cardiac autonomic neuropathy ( CAN ) and elevated nocturnal blood pressure are independent risk factors for cardiovascular disease in patients with diabetes .
BACKGROUND	Previously , associations between CAN , non-dipping of nocturnal blood pressure and coronary artery calcification have been demonstrated .
BACKGROUND	The present protocol describes a trial to test the efficacy of bedtime dosing of the ACE inhibitor enalapril on night time blood pressure and left ventricular mass in patients with type 1 diabetes .
METHODS	In a randomised , double-blind , two-way cross-over study , 24 normoalbuminuric patients with type 1 diabetes with CAN will be treated for 12weeks with either morning or bedtime dosing of 20mg enalapril , followed by 12weeks of switched treatment regimen .
METHODS	During each treatment period , two 24h ambulatory blood pressure measurements will be performed and after each treatment period left ventricular mass will be determined by multisliced CT. .
METHODS	Primary end points will be reduction in blood pressure and reduction in left ventricular mass .
BACKGROUND	The study has been approved by the Danish Medicines Agency , the Scientific-Ethical Committee of the Capital Region of Denmark and the Danish Data Protection Agency .
BACKGROUND	An external monitoring committee ( the Good Clinical Practice Unit at Copenhagen University Hospital ) will oversee the study .
BACKGROUND	The results of the study will be presented at national and international scientific meetings and publications will be submitted to peer-reviewed journals .
BACKGROUND	EudraCT ( 2012 - 002136-90 ) .

###25855628
OBJECTIVE	To analyze prospectively the hypothalamic-pituitary-adrenal ( HPA ) axis and clinical outcome in patients treated with prednisone for exacerbated chronic obstructive pulmonary disease ( COPD ) .
METHODS	Prospective observational study .
METHODS	Patients presenting to the emergency department were randomized to receive 40mg prednisone daily for 5 or 14 days in a placebo-controlled manner .
METHODS	The HPA axis was longitudinally assessed with the 1g corticotropin test and a clinical hypocortisolism score at baseline , on day 6 before blinded treatment , at hospital discharge , and for up to 180 days of follow-up .
METHODS	Prednisone was stopped abruptly , irrespective of the test results .
METHODS	Patients discharged with pathological test results received instructions about emergency hydrocortisone treatment .
RESULTS	A total of 311 patients were included in the analysis .
RESULTS	Mean basal and stimulated serum total cortisol levels were highest on admission ( 496398 and 816413nmol/l respectively ) and lowest on day 6 ( 235174 and 453178nmol/l respectively ) .
RESULTS	Pathological stimulation tests were found in 63 , 38 , 9 , 3 , and 2 % of patients on day 6 , at discharge , and on days 30 , 90 , and 180 respectively , without significant difference between treatment groups .
RESULTS	Clinical indicators of hypocortisolism did not correlate with stimulation test results , but cortisol levels were inversely associated with re-exacerbation risk .
RESULTS	There were no hospitalizations or deaths as a result of adrenal crisis .
CONCLUSIONS	Dynamic changes in the HPA axis occur during and after the treatment of acute exacerbations of COPD .
CONCLUSIONS	In hypocortisolemic patients who were provided with instructions about stress prophylaxis , the abrupt termination of prednisone appeared safe .

###25847554
OBJECTIVE	To compare the clinical efficacy of Black seeds and Turmeric alone and its co-administration in lower doses among patients with metabolic syndrome ( MetS ) .
METHODS	Double-blind-randomized-controlled trial .
METHODS	Hijrat colony , Karachi , Pakistan .
METHODS	Apparently healthy males ( n = 250 ) , who screened positive for MetS , were randomized to either Black seeds ( 1.5 g/day ) , Turmeric ( 2.4 g/day ) , its combination ( 900mg Black seeds and 1.5 g Turmeric/day ) or placebo for 8 weeks .
METHODS	body-mass-index ( BMI ) , body-fat-percent ( BF % ) , waist-circumference ( WC ) , hip-circumference ( HC ) , blood pressure ( BP ) , lipid-profile ( cholesterol , HDL-cholesterol , LDL-cholesterol and TG ) , fasting blood glucose ( FBG ) and c-reactive protein ( CRP ) .
RESULTS	At 4 weeks , compared to baseline , Black seed and Turmeric alone showed improvement in BMI , WC and BF % .
RESULTS	Combination improved all parameters except HDL-cholesterol with lower FBG and LDL-cholesterol as compared to placebo .
RESULTS	At 8 weeks , compared to placebo , Black seeds reduced lipids and FBG , while Turmeric reduced LDL-cholesterol and CRP .
RESULTS	Interestingly , combination group with 60 % dose of the individual herbs showed an improvement in all parameters from baseline .
RESULTS	When compared to placebo , it reduced BF % , FBG , cholesterol , TG , LDL-cholesterol , CRP and raised HDL-cholesterol .
CONCLUSIONS	Turmeric and Black seeds showed improvement in all parameters of metabolic syndrome , when co-administered at 60 % of doses of individual herbs with enhanced efficacy and negligible adverse-effects .
CONCLUSIONS	The combination of Black seeds and Turmeric can therefore , be recommended with lifestyle modification as a starting point for patients with MetS to halt its future complications and progression .

###24579282
OBJECTIVE	The aim of this study was to assess the effect of an active and novel distraction technique WITAUL ( Writing In The Air Using Leg ) on the pain behavior observed and reported by children receiving local anesthesia injections prior to dental treatment .
METHODS	The study was conducted on 160 children ( 80 in control and 80 in intervention group ) between the ages of 4 - 10 years .
METHODS	During the administration of anesthesia the children in the control group were made to relax by means of deep breathing and those in the intervention group were taught to use the WITAUL distraction technique .
METHODS	the behavior of the children aged 4 - 5 years was noted using the Modified Toddler - Preschooler Post operative Pain Scale ( TPPPS ) and that of children aged above 6 years was measured using the FACES Pain Scale-Revised ( FPS-R ) .
RESULTS	The use of WITAUL was found to be statistically significant ( p value < 0.0001 ) compared to the control method in serving as a distraction and hence in managing pain during local anesthesia administration .
RESULTS	The mean Modified TPPPS scores ( 4 - 5 year olds ) for the WITAL group was 2.46 + / - 1.752 and that of the control was 5.64 + / - 2.328 .
RESULTS	The mean FPS-R scores ( 6 - 10 year olds ) for the WITAUL group was 3 + / - 1.748 and that of the control group was 6.26 + / - 1.858 .
CONCLUSIONS	The WITAUL technique therefore appears to be a simple and effective method of distraction during local anesthesia administration in pediatric patients .

###25586754
OBJECTIVE	Both antidepressant medications and psychological therapy are common treatments for depression in postpartum women .
OBJECTIVE	Antidepressant treatment may have a number of practical disadvantages , including a preference by women to avoid medication while breastfeeding .
OBJECTIVE	Consequently , more information about the relative benefits of the two modalities in the perinatal period is helpful .
OBJECTIVE	In the treatment of depressive disorders there is some evidence that combination therapies ( pharmacological plus psychological treatment ) may be more efficacious than either form of mono-therapy in isolation .
OBJECTIVE	However , in the treatment of postnatal depression , such evidence is limited .
METHODS	Forty five postpartum women with a DSM-IV diagnosis of depression were randomised to receive either : 1 ) cognitive behavioural therapy ( CBT ) ; 2 ) sertraline , or 3 ) a combination of both treatment modalities .
METHODS	Psychometric measures were collected weekly for 12 weeks , with a follow-up at 24 weeks .
RESULTS	Symptoms of depression and anxiety were reduced to a significant degree following all three treatments .
RESULTS	CBT mono-therapy was found to be superior to both sertraline mono-therapy and combination therapy after 12 weeks .
RESULTS	The CBT mono-therapy group appeared to display the most rapid initial gains after treatment commencement .
CONCLUSIONS	In this sample , a specialised CBT program for postnatal depression was found to be superior as a mono-therapy compared to sertraline , a commonly prescribed SSRI antidepressant .
CONCLUSIONS	This is in contrast to previous studies which have found no detectable difference in the efficacies of drug and psychological treatment for postnatal depression .
CONCLUSIONS	Unlike some previous work , this study allowed a statistically independent evaluation of CBT mono-therapy for postnatal depression compared to both antidepressant and combination therapy .
CONCLUSIONS	In line with previous studies in postpartum women , there was no detectable advantage of combining pharmacological and psychological treatments in the short term .

###26403017
OBJECTIVE	Determine changes in cognition and post-traumatic stress disorder ( PTSD ) symptoms in subjects with traumatic brain injury ( TBI ) exposed to 2.4 atmospheres absolute ( atm abs ) breathing 100 % oxygen vs. sham ( 1.3 atm-abs air ) .
METHODS	Fifty randomized subjects completed a total of 30 exposures .
METHODS	A concussion history was taken , then baseline , post-series , and six-week follow-up immediate post-concussion assessment and cognitive testing , Brain-checkers and PTSD Checklist for Military ( PCL-M ) tests were administered .
RESULTS	No statistically significant differences between groups were noted , but both groups improved .
RESULTS	Subgroups analyses , based on concussion history and individual test components , showed improvement in the treatment group vs. the sham .
RESULTS	These subgroups included the number of concussive events , time from event to consent , loss of consciousness , visual memory , processing , go -- no go , and simple reaction time .
CONCLUSIONS	There was no statistically significant difference between a sham and 2.4 atm abs hyperbaric oxygen ( HBO2 ) in cognitive scores from ImPACT and Brain-checkers or composite scores in the PCL-M ; however both groups showed improvement .
CONCLUSIONS	Subgroups with favorable response to treatment are identified .
CONCLUSIONS	Future studies evaluating HBO2 should consider concussion histories or focus on validating subgroup response to determine HBO2 as a potential adjunctive treatment for persistent symptoms following TBI .

###24819327
BACKGROUND	We conducted a prospective randomized controlled noninferiority trial to compare objective and subjective outcomes of retropubic tension-free vaginal tape ( TVT ) with those of transobturator tape ( TVT-O ) as primary treatment for stress urinary incontinence ( SUI ) in women .
METHODS	The study was conducted at 25 gynecology units in Austria and Germany ; regional and academic hospitals participated .
METHODS	A total of 569 patients were randomly assigned to undergo TVT or TVT-O .
RESULTS	A total of 480 patients ( 85 % ) were examined at 3 months .
RESULTS	A negative cough stress test with stable cystometry to 300 ml was seen in 87 % of patients after TVT and in 84 % after TVT-O ; 64 % and 59 % of patients , respectively , reported no pad use , and 88 % of patients in both groups considered themselves much or very much better on the Patient Global Impression of Improvement ( PGI-I ) scale .
RESULTS	Quality of life ( QoL ) as assessed with the SF-12 Health Survey , Kings ' Health Questionnaire , ( KHQ ) , and EuroQol-5D ( EQ-5D ) was significantly improved in both arms , with no differences between arms .
RESULTS	There were no significant differences in postoperative pain or complications .
CONCLUSIONS	Results of this trial demonstrate noninferiority between TVT and TVT-O with regard to postoperative continence and QoL and suggest little difference in perioperative problems ( ClinicalTrials.gov NCT 00441454 ) .

###25394865
BACKGROUND	Hip fractures incur the greatest medical costs of any fracture .
BACKGROUND	Valid epidemiological data are important to monitor for time-dependent changes .
BACKGROUND	In Norway , hip fractures are registered in the Norwegian Patient Registry ( NPR ) , but no published national validation exists .
BACKGROUND	The aim of the present study was a national validation of NPR as a register for hip fractures using diagnostic codes ( ICD-10 S 72.0-2 ) and/or procedure codes ( NOMESCO version 1.14 NFBxy ( x = 0-9 , y = 0-2 ) or NFJxy ( x = 0-9 , y = 0-2 ) .
METHODS	A nationwide , population-based cohort comprising a random sub-sample of 1,000 hip fracture-related entries for the years 2008-09 was drawn from the NPR .
METHODS	200 entries were defined by a combination of diagnostic and procedure codes ( subsample 1 ) , 400 entries were defined by diagnostic codes only ( subsample 2 ) and 400 entries were defined by procedure codes only ( subsample 3 ) .
METHODS	Accuracy was ascertained through comparison with discharge summaries , procedure notes and X-ray reports requested from 40 health institutions .
METHODS	Comparisons between groups were done by chi2 for categorical and t-test for continuous variables .
RESULTS	792 health records from 32 institutions were reviewed .
RESULTS	High accuracy ( 98.2 % , 95 % C.I. 96.5-99 .9 % ) was found for subsample 1 , a combination of diagnostic and procedure codes .
RESULTS	Coding errors were prominent in other subsamples .
RESULTS	Defining fractures by a combination of diagnostic and procedure codes , annual average hip fracture incidence in Norway was 9,092 ( 95 % C.I. 8,934 -9,249 ) , excluding only 6.5 % of all hip fractures defined by wider definitions .
CONCLUSIONS	Based on current coding practice in Norway , a reliable national estimate of hip fracture incidences is found by a combination of relevant ICD-10 and NOMESCO codes in the NPR .
CONCLUSIONS	This method may be used for monitoring epidemiological changes .

###24521953
OBJECTIVE	This study was undertaken to identify a preferred dosing strategy for patients undergoing coronary artery bypass grafting or valve replacement procedures with cardiopulmonary bypass .
METHODS	Patients undergoing coronary artery bypass grafting , valve replacement surgery , or both were randomly assigned to receive either standard 1-g dosing with vancomycin before and after cardiopulmonary bypass or a single weight-based 20-mg/kg dose before surgery .
METHODS	The primary outcome was the percentage of time plasma concentrations were greater than 15 g/mL during cardiopulmonary bypass and at surgical closure .
METHODS	Secondary outcomes included concentration of vancomycin in endothoracic tissue after vancomycin infusion , average time patients had vancomycin concentrations greater than 15 g/mL , and vancomycin plasma and tissue pharmacokinetic parameters .
RESULTS	Baseline characteristics were similar between the study dosing group ( n = 10 ) and the standard dosing group ( n = 10 ) .
RESULTS	From postinfusion to end of bypass , the median percentage of time vancomycin concentrations remained greater than 15 g/mL was 100 % ( interquartile range [ IQR ] , 72.6 % -100 % ) for weight-based dosing versus 43.7 % ( IQR , 28.7 % -53.4 % ) for standard dosing ( P = .0005 ) .
RESULTS	From postinfusion to surgical closure , the percentage of time vancomycin concentrations remained greater than 15 g/mL was significantly higher in the weight-based group ( 100 % [ IQR , 58.3 % -100 % ] vs 34.6 % [ IQR , 25.3 % -41.6 % ] ; P = .0005 ) .
RESULTS	Weight-based dosing increased calculated time with vancomycin concentrations greater than 15 g/mL and resulted in higher endothoracic tissue vancomycin concentrations .
CONCLUSIONS	Weight-based vancomycin dosing before coronary artery bypass grafting or valve replacement results in vancomycin concentrations greater than 15 g/mL consistently more than does standard 1-g dosing .

###24767875
BACKGROUND	Numerous open trials have demonstrated the beneficial clinical effects of aspirin desensitization ( AD ) in patients with aspirin-induced asthma ( AIA ) .
BACKGROUND	These beneficial effects might be attributable to aspirin 's potent anti-inflammatory properties , but that supposition requires further corroboration .
OBJECTIVE	We sought to compare the clinical and biochemical responses to chronic oral AD in 20 patients with AIA and 14 patients with aspirin-tolerant asthma ( ATA ) .
OBJECTIVE	All of the patients had chronic rhinosinusitis and nasal polyposis , and these responses were investigated in a pilot , double-blind , placebo-controlled study .
METHODS	Twelve patients with AIA and 6 patients with ATA were randomly assigned to receive 624 mg of aspirin , and 8 patients with AIA and 8 patients with ATA received placebo .
METHODS	Both aspirin and placebo were administered once daily for 6 months .
METHODS	Nasal symptoms , Sino-Nasal Outcome Test ( SNOT20 ) scores , peak nasal inspiratory flows , Asthma Control Questionnaire scores , spirometric parameters , peak expiratory flows , blood eosinophilia , and corticosteroid doses were assessed on a monthly basis .
METHODS	Levels of urinary leukotriene E4 and the stable plasma prostaglandin ( PG ) D2 metabolite 9,11-PGF2 were evaluated at baseline and after 1 , 3 , 5 , and 6 months .
RESULTS	Only the patients with AIA subjected to AD reported improvements in smell and reductions in sneezing and nasal blockade .
RESULTS	The SNOT20 and Asthma Control Questionnaire scores of these patients decreased , and their peak nasal inspiratory flows increased .
RESULTS	The dosages of inhaled corticosteroids were reduced .
RESULTS	There were no changes in leukotriene E ( 4 ) or 9,11-PGF ( 2 ) levels after AD .
CONCLUSIONS	The clinically beneficial effects of AD on nasal and bronchial symptoms occurred only in the patients with AIA .

###25041441
OBJECTIVE	To evaluate repeated subgingival air-polishing in residual pockets with a new erythritol powder containing 0.3 % chlorhexidine .
METHODS	Single-centre , examiner masked , randomized clinical trial of 12months with a two-arm , within-subject parallel design .
METHODS	Fifty patients in periodontal maintenance were monitored in 3-month intervals .
METHODS	At months 0 , 3 , 6 and 9 , all sites presenting with a probing depth ( PD ) > 4mm were subject to subgingival air-polishing ( test side ) or ultrasonic debridement ( control side ) .
METHODS	The primary endpoint was presence/absence of PD > 4mm after 12months .
RESULTS	Totally 6918 sites were monitored at baseline , 457 of them had a PD > 4mm ( range 5-9mm ) .
RESULTS	The number of pockets > 4mm per subject , PD and bleeding on probing were significantly lower at month 12 .
RESULTS	Differences between test and control were not significant .
RESULTS	There was a significant difference in favour of air-polishing for the perception of pain/discomfort .
RESULTS	Differences of frequencies at > 1000 and > 100,000 cells/ml of six microorganisms between baseline and month 12 were not significant .
RESULTS	At month 12 , test sites were less frequently positive for Aggregatibacter actinomycetemcomitans at > 1000cells/ml than controls , and counts never exceeded 100,000 cells/ml .
CONCLUSIONS	Repeated subgingival air-polishing reduced the number of pockets > 4mm similar to ultrasonic debridement .
CONCLUSIONS	It was safe and induced less pain .

###24389883
OBJECTIVE	Lumbar puncture ( LP ) is one of the most common procedures performed in medicine .
OBJECTIVE	The aim of this prospective study is to determine the success rate of LP in lateral decubitus with 45-degree head-up tilt position , and compare it with traditional positions like sitting and lateral decubitus .
METHODS	Three hundred and thirty patients between 25 and 85 years of age who had undergone abdominal , urologic , and lower limb extremities surgeries were enrolled and 300 patients were divided into three different groups .
METHODS	The LP was performed with a 25-G atraumatic needle , either in the standard sitting position ( group S , n = 100 ) , lateral decubitus , knee-chest position ( group L , n = 100 ) or lateral decubitus , knee-chest position with a 45-degree head-up tilt ( group M , n = 100 ) .
METHODS	The free flow of clear cerebrospinal fluid ( CSF ) upon first attempt was considered to be evidence of a successful LP .
RESULTS	Total LP success rate was significantly higher in group M ( 85 % ) than in groups S and L ( 70 and 65 % , respectively ) ( p = 0.004 ) .
RESULTS	When the significance between the groups was evaluated according to age , the increase in the LP success rate was not significant for 65 and > 65 age groups .
RESULTS	There were no differences among the three groups in terms of bloody CSF ( p = 0.229 ) and the number of attempts before dural puncture ( p = 0.052 ) .
CONCLUSIONS	The lateral decubitus in knee-chest position with a 45-degree head-up tilt may be the preferred position for spinal anesthesia in young and elderly patients , due to the high success rate .

###25443696
BACKGROUND	Classification of chronic heart failure ( HF ) is on the basis of criteria that may not adequately capture disease heterogeneity .
BACKGROUND	Improved phenotyping may help inform research and therapeutic strategies .
OBJECTIVE	This study used cluster analysis to explore clinical phenotypes in chronic HF patients .
METHODS	A cluster analysis was performed on 45 baseline clinical variables from 1,619 participants in the HF-ACTION ( Heart Failure : A Controlled Trial Investigating Outcomes of Exercise Training ) study , which evaluated exercise training versus usual care in chronic systolic HF .
METHODS	An association between identified clusters and clinical outcomes was assessed using Cox proportional hazards modeling .
METHODS	Differential associations between clinical outcomes and exercise testing were examined using interaction testing .
RESULTS	Four clusters were identified ( ranging from 248 to 773 patients in each ) , in which patients varied considerably among measures of age , sex , race , symptoms , comorbidities , HF etiology , socioeconomic status , quality of life , cardiopulmonary exercise testing parameters , and biomarker levels .
RESULTS	Differential associations were observed for hospitalization and mortality risks between and within clusters .
RESULTS	Compared with cluster 1 , risk of all-cause mortality and/or all-cause hospitalization ranged from 0.65 ( 95 % confidence interval [ 95 % CI ] : 0.54 to 0.78 ) for cluster 4 to 1.02 ( 95 % CI : 0.87 to1 .19 ) for cluster 3 .
RESULTS	However , for all-cause mortality , cluster 3 had a disproportionately lower risk of 0.61 ( 95 % CI : 0.44 to 0.86 ) .
RESULTS	Evidence suggested differential effects of exercise treatment on changes in peak oxygen consumption and clinical outcomes between clusters ( p for interaction < 0.04 ) .
CONCLUSIONS	Cluster analysis of clinical variables identified 4 distinct phenotypes of chronic HF .
CONCLUSIONS	Our findings underscore the high degree of disease heterogeneity that exists within chronic HF patients and the need for improved phenotyping of the syndrome .
CONCLUSIONS	( Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure ; NCT00047437 ) .

###25255696
BACKGROUND	Despite the considerable injury burden attributable to falls at home among the general population , few effective safety interventions have been identified .
BACKGROUND	We tested the safety benefits of home modifications , including handrails for outside steps and internal stairs , grab rails for bathrooms , outside lighting , edging for outside steps , and slip-resistant surfacing for outside areas such as decks and porches .
METHODS	We did a single-blind , cluster-randomised controlled trial of households from the Taranaki region of New Zealand .
METHODS	To be eligible , participants had to live in an owner-occupied dwelling constructed before 1980 and at least one member of every household had to be in receipt of state benefits or subsidies .
METHODS	We randomly assigned households by electronic coin toss to either immediate home modifications ( treatment group ) or a 3-year wait before modifications ( control group ) .
METHODS	Household members in the treatment group could not be masked to their assigned status because modifications were made to their homes .
METHODS	The primary outcome was the rate of falls at home per person per year that needed medical treatment , which we derived from administrative data for insurance claims .
METHODS	Coders who were unaware of the random allocation analysed text descriptions of injuries and coded injuries as all falls and injuries most likely to be affected by the home modifications tested .
METHODS	To account for clustering at the household level , we analysed all injuries from falls at home per person-year with a negative binomial generalised linear model with generalised estimating equations .
METHODS	Analysis was by intention to treat .
METHODS	This trial is registered with the Australian New Zealand Clinical Trials Registry , number ACTRN12609000779279 .
RESULTS	Of 842 households recruited , 436 ( n = 950 individual occupants ) were randomly assigned to the treatment group and 406 ( n = 898 occupants ) were allocated to the control group .
RESULTS	After a median observation period of 1148 days ( IQR 1085-1263 ) , the crude rate of fall injuries per person per year was 0.061 in the treatment group and 0.072 in the control group ( relative rate 0.86 , 95 % CI 0.66-1 .12 ) .
RESULTS	The crude rate of injuries specific to the intervention per person per year was 0.018 in the treatment group and 0.028 in the control group ( 0.66 , 0.43-1 .00 ) .
RESULTS	A 26 % reduction in the rate of injuries caused by falls at home per year exposed to the intervention was estimated in people allocated to the treatment group compared with those assigned to the control group , after adjustment for age , previous falls , sex , and ethnic origin ( relative rate 0.74 , 95 % CI 0.58-0 .94 ) .
RESULTS	Injuries specific to the home-modification intervention were cut by 39 % per year exposed ( 0.61 , 0.41-0 .91 ) .
CONCLUSIONS	Our findings suggest that low-cost home modifications and repairs can be a means to reduce injury in the general population .
CONCLUSIONS	Further research is needed to identify the effectiveness of particular modifications from the package tested .
BACKGROUND	Health Research Council of New Zealand .

###24278177
BACKGROUND	Enterovirus 71 ( EV71 ) has caused several epidemics of hand , foot and mouth diseases ( HFMD ) in Asia .
BACKGROUND	No effective EV71 vaccine is available .
BACKGROUND	A randomized and open-label phase I clinical study registered with ClinicalTrials.gov #NCT 01268787 , aims to evaluate the safety , reactogenicity and immunogenicity of a formalin-inactivated EV71 vaccine candidate ( EV71vac ) at 5 - and 10-g doses .
BACKGROUND	In this study we report the cross-neutralizing antibody responses from each volunteer against different subgenotypes of EV71 and CVA16 .
METHODS	Sixty eligible healthy adults were recruited and vaccinated .
METHODS	Blood samples were obtained on day 0 , 21 and 42 and tested against B1 , B4 , B5 , C2 , C4A , C4B and CVA16 for cross-neutralizing antibody responses .
RESULTS	The immunogenicity of both 5 - and 10 - g doses were found to be very similar .
RESULTS	Approximately 45 % of the participants had < 8 pre-vaccination neutralization titers ( Nt ) against the B4 vaccine strain .
RESULTS	After the first EV71vac immunization , 95 % of vaccinees have > 4-fold increase in Nt , but there was no further increase in Nt after the second dose .
RESULTS	EV71vac induced very strong cross-neutralizing antibody responses in > 85 % of volunteers without pre-existing Nt against subgenotype B1 , B5 and C4A .
RESULTS	EV71vac elicited weak cross-neutralizing antibody responses ( 20 % of participants ) against a C4B and Coxsackie virus A16 .
RESULTS	Over 90 % of vaccinated volunteers did not develop cross-neutralizing antibody responses ( Nt < 8 ) against a C2 strain .
RESULTS	EV71vac can boost and significantly enhance the neutralizing antibody responses in volunteers who already had pre-vaccination antibodies against EV71 and/or CVA16 .
CONCLUSIONS	EV71vac is efficient in eliciting cross-neutralizing antibody responses against EV71 subgenotypes B1 , B4 , B5 , and C4A , and provides the rationale for its evaluation in phase II clinical trials .
BACKGROUND	ClinicalTrials.gov NCT01268787 .

###24402803
BACKGROUND	Microemboli are frequently detected entering the middle cerebral arteries during coronary angiography ( CA ) .
BACKGROUND	Recent studies have reported that cerebral microemboli , especially particulate cerebral microemboli , may cause silent ischemic cerebral lesions .
OBJECTIVE	To investigate whether the occurrence of particulate cerebral microemboli during diagnostic CA is influenced by which guidewire technique is used .
METHODS	Patients with stable angina pectoris or non-ST elevation acute coronary syndrome , referred for CA , were randomized to initial advancement of catheters with a leading guidewire over the aortic arch or to initial guidewire withdrawal in the descending aorta with advancement of catheters alone .
METHODS	After completed CA ( part 1 ) , new catheters and guidewires were advanced with guidewire technique contrary to the one first used ( part 2 ) .
METHODS	Patients were continuously monitored with transcranial Doppler ( TCD ) , and cerebral microemboli were automatically counted and differentiated .
RESULTS	Statistical analysis was performed on 41 patients .
RESULTS	The results in part 1 were confirmed in part 2 .
RESULTS	The median number ( interquartile range ) of particulate cerebral microemboli was significantly higher when catheters were advanced with , compared to without , a guidewire over the aortic arch ; overall , 6 ( IQR , 1-9 ) vs 1 ( IQR , 0-3 ) ; P = .01 .
CONCLUSIONS	Advancement of catheters with a leading guidewire over the aortic arch with subsequent flushing in the ascending aorta consistently generated more particulate cerebral microemboli , implying that the choice of guidewire technique has an impact on the risk for cerebral lesions during CA .

###24449241
OBJECTIVE	Bortezomib-melphalan-prednisone ( VMP ) has improved overall survival in multiple myeloma .
OBJECTIVE	This randomized trial compared VMP plus thalidomide ( VMPT ) induction followed by bortezomib-thalidomide maintenance ( VMPT-VT ) with VMP in patients with newly diagnosed multiple myeloma .
METHODS	We randomly assigned 511 patients who were not eligible for transplantation to receive VMPT-VT ( nine 5-week cycles of VMPT followed by 2 years of VT maintenance ) or VMP ( nine 5-week cycles without maintenance ) .
RESULTS	In the initial analysis with a median follow-up of 23 months , VMPT-VT improved complete response rate from 24 % to 38 % and 3-year progression-free-survival ( PFS ) from 41 % to 56 % compared with VMP .
RESULTS	In this analysis , median follow-up was 54 months .
RESULTS	The median PFS was significantly longer with VMPT-VT ( 35.3 months ) than with VMP ( 24.8 months ; hazard ratio [ HR ] , 0.58 ; P < .001 ) .
RESULTS	The time to next therapy was 46.6 months in the VMPT-VT group and 27.8 months in the VMP group ( HR , 0.52 ; P < .001 ) .
RESULTS	The 5-year overall survival ( OS ) was greater with VMPT-VT ( 61 % ) than with VMP ( 51 % ; HR , 0.70 ; P = .01 ) .
RESULTS	Survival from relapse was identical in both groups ( HR , 0.92 ; P = .63 ) .
RESULTS	In the VMPT-VT group , the most frequent grade 3 to 4 adverse events included neutropenia ( 38 % ) , thrombocytopenia ( 22 % ) , peripheral neuropathy ( 11 % ) , and cardiologic events ( 11 % ) .
RESULTS	All of these , except for thrombocytopenia , were significantly more frequent in the VMPT-VT patients .
CONCLUSIONS	Bortezomib and thalidomide significantly improved OS in multiple myeloma patients not eligible for transplantation .

###25587645
OBJECTIVE	Binge-eating disorder ( BED ) , a public health problem associated with psychopathological symptoms and obesity and possibly with metabolic syndrome , lacks approved pharmacotherapies .
OBJECTIVE	To examine the efficacy and safety of lisdexamfetamine dimesylate , a dextroamphetamine prodrug , to treat moderate to severe BED .
METHODS	We performed a randomized , double-blind , parallel-group , forced dose titration , placebo-controlled clinical trial at 30 sites from May 10 , 2011 , through January 30 , 2012 .
METHODS	Safety and intention-to-treat analyses included 259 and 255 adults with BED , respectively .
METHODS	Lisdexamfetamine dimesylate at dosages of 30 , 50 , or 70 mg/d or placebo were provided to study participants ( 1:1:1:1 ) .
METHODS	Dosages were titrated across 3 weeks and maintained for 8 weeks .
METHODS	We followed up participants for a mean ( SD ) of 7 ( 2 ) days after the last dose .
METHODS	We assessed the change in binge-eating ( BE ) behaviors measured as days per week ( baseline to week 11 ) with a mixed-effects model using transformed log ( BE days per week ) +1 .
METHODS	Secondary measures included BE cessation for 4 weeks .
METHODS	Safety assessments included treatment-emergent adverse events , vital signs , and change in weight .
RESULTS	At week 11 , log-transformed BE days per week decreased with the 50-mg/d ( least squares [ LS ] mean [ SE ] change , -1.49 [ 0.066 ] ; P = .008 ) and 70-mg/d ( LS mean [ SE ] change , -1.57 [ 0.067 ] ; P < .001 ) treatment groups but not the 30-mg/d treatment group ( LS mean [ SE ] change , -1.24 [ 0.067 ] ; P = .88 ) compared with the placebo group .
RESULTS	Nontransformed mean ( SD ) days per week decreased for placebo and the 30 - , 50 - , and 70-mg/d treatment groups by -3.3 ( 2.04 ) , -3.5 ( 1.95 ) , -4.1 ( 1.52 ) , and -4.1 ( 1.57 ) , respectively .
RESULTS	The percentage of participants achieving 4-week BE cessation was lower with the placebo group ( 21.3 % ) compared with the 50-mg/d ( 42.2 % [ P = .01 ] ) and 70-mg/d ( 50.0 % [ P < .001 ] ) treatment groups .
RESULTS	The incidence of any treatment-emergent adverse events was 58.7 % for the placebo group and 84.7 % for the combined treatment group .
RESULTS	In the treatment groups , 1.5 % of participants had serious treatment-emergent adverse effects .
RESULTS	Events with a frequency of at least 5 % and changes in heart rate were generally consistent with the known safety profile .
RESULTS	The mean ( SD ) change in body weight was -0.1 ( 3.09 ) , -3.1 ( 3.64 ) , -4.9 ( 4.43 ) , -4.9 ( 3.93 ) , and -4.3 ( 4.09 ) kg for the placebo group , the 30 - , 50 - , and 70-mg/d treatment groups , and the combined treatment groups , respectively ( P < .001 for each dose vs placebo group comparison in post hoc analysis ) .
CONCLUSIONS	The 50 - and 70-mg/d treatment groups demonstrated efficacy compared with the placebo group in decreased BE days , BE cessation , and global improvement .
CONCLUSIONS	The safety profile was generally consistent with previous findings in adults with attention-deficit/hyperactivity disorder .
CONCLUSIONS	Further investigation of lisdexamfetamine in BED is ongoing .
BACKGROUND	clinicaltrials.gov Identifier : NCT01291173 .

###25157951
OBJECTIVE	To investigate the safety and satisfaction of patients treated 14 days after unilateral bunionectomy with extended-release oxycodone/acetaminophen ( ER OC/APAP ) , a biphasic ( ER and immediate release ) fixed-dose combination analgesic being developed for moderate to severe acute pain .
METHODS	This was an open-label extension ( OLE ) of a randomized , double-blind , placebo-controlled trial ( DBRCT ) of patients undergoing bunionectomy .
METHODS	Patients who consented to the OLE before entering the 48 hour DBRCT entered the OLE upon completing the DBRCT and during the OLE received two tablets of ER OC/APAP ( 15/650mg total dose ) every 12 hours for 14 days .
METHODS	ClinicalTrials identifier : NCT01484652 .
METHODS	Treatment-emergent adverse events , physical examinations , vital sign measurements , and clinical laboratory testing were assessed throughout the study .
METHODS	Global assessments of treatment satisfaction were made at the end of the DBRCT and at each clinic visit during the OLE .
RESULTS	A total of 146 patients consented to the OLE before entering the DBRCT and 129 completed the OLE .
RESULTS	Tolerability of ER OC/APAP during the OLE was consistent with that of an opioid product .
RESULTS	Adverse events occurred during the OLE in 64 patients ( 43.8 % ) ; the most common were gastrointestinal events including nausea ( 17.8 % ) , vomiting ( 7.5 % ) , and constipation ( 6.2 % ) .
RESULTS	No changes in vital signs or clinical laboratory tests were considered by the investigator to be clinically significant .
RESULTS	At all visits during the OLE , the majority of patients were satisfied or very satisfied with their medication .
RESULTS	Limitations include a 14 day postprocedure study duration that may be confounded with natural healing time , and lack of a placebo arm .
CONCLUSIONS	These results show that ER OC/APAP demonstrated an expected safety and tolerability profile and good patient satisfaction in a postsurgical model of acute pain .

###25449225
OBJECTIVE	To assess whether the addition of heated humidified gas ( HHG ) at delivery and until neonatal unit arrival improved admission temperatures of preterm infants .
METHODS	This multicenter , randomized controlled trial was performed in New Zealand and The Netherlands .
METHODS	Infants < 32 weeks ' gestation who required respiratory support after delivery were randomized to either cold , dry gas or HHG from birth .
METHODS	Standard measures to prevent hypothermia included heated delivery rooms , the use of radiant warmers , body wrap , and head covering .
METHODS	The primary outcome was axillary temperature in the normothermic ( 36.5-37 .5 C ) range on admission to a neonatal intensive care unit .
METHODS	Secondary outcomes were measures of respiratory support and neonatal morbidities .
METHODS	The effect of humidification was analyzed by the use of logistic regression .
RESULTS	Of 203 randomized infants , 100 received HHG ( humidifier set to 37C ) and 103 received cold , dry gas .
RESULTS	In the HHG group , 69 ( 69 % ) were normothermic compared with 57 ( 55 % ) in the cold , dry gas group ( unadjusted OR 1.8 , 95 % CI 1.01-3 .19 ) .
RESULTS	A greater number of infants < 28 weeks were normothermic on admission in the HHG group ( 24/35 ; ie , 69 % ) compared with the cold , dry gas group ( 16/38 ; ie , 42 % ; P = .03 ) .
RESULTS	In addition , 2 ( 2 % ) infants in the HHG group had admission temperatures < 35.5 C compared with 12 ( 12 % ) in the cold , dry gas group ( P = .007 ) .
RESULTS	Respiratory and short-term outcomes were not different .
CONCLUSIONS	Adding HHG during respiratory support in preterm infants from birth increased the incidence of normothermia at admission .

###24955858
OBJECTIVE	On-call duty ( OCD ) is frequently associated with health and safety risks for both physicians and patients .
OBJECTIVE	The lack of studies conducted in clinical care environments and the ongoing public dialogue concerning OCD led to a detailed investigation of a working schedule including sleep fragmentation and extended work hours .
METHODS	Within-person randomized cross-over trial .
METHODS	Comparison of a 24h on-call shift ( OCD ) compared to a routine working-day ( non on call , NOC ) in hospital .
METHODS	30 residents and senior physicians of the Department of Internal Medicine , Neurology and Otorhinolaryngology at the University Hospital Innsbruck .
METHODS	Sleep variables , cognitive performance ( Concentration-Endurance d2 test ) , emotional status ( Eigenschaftswoerterliste 60S ) , serum-cortisol , urinary cortisol and noradrenaline , heart-rate variability , and saccadic eye movements were determined before and after OCD and NOC respectively .
RESULTS	Concentration-endurance performance was significantly reduced after OCD as compared to NOC by 16.4 % ( p < 0.001 ) .
RESULTS	Changes in emotional status consisted in a reduction of subjective concentration and performance related activation after OCD by 17.4 % ( p < 0.001 ) and 16.0 % ( p < 0.001 ) respectively together with a 21.8 % increase of general deactivation ( p < 0.001 ) and a 29.2 % rise of fatigue ( p < 0.001 ) .
RESULTS	On the contrary , subjective activation and raised mood showed an 18.3 % and 21.7 % increase after OCD ( p < 0.01 ) .
RESULTS	Urinary noradrenaline excretion ( 46 g/24 h , 19-97 ) was greater during OCD when compared to NOC ( 36 g/24 h , 10-54 , p < 0.01 ) .
RESULTS	Sympathetic activity measured by heart rate variability was significantly higher during OCD in contrast to NOC ( p < 0.05 ) .
RESULTS	Serum-cortisol was lower in the morning after ( 132 ng/l , 60-273 ) than the morning before OCD ( p < 0.01 ) .
RESULTS	Finally , the number of short saccadic latencies was reduced after OCD ( p < 0.05 ) compared to NOC .
CONCLUSIONS	24 h OCD alters both , the sympathetic-adrenomedullary system as well as the hypothalamic pituitary-adrenocortical axis .
CONCLUSIONS	Moreover , physicians ' emotional state , cognitive and oculomotor performance seems to be influenced independently from sleep interruptions .
CONCLUSIONS	The discrepancy between subjective feeling and objective cognitive impairments pose a risk for performing complex manual and cognitive tasks .
CONCLUSIONS	Hence , our findings argue against an oversimplified interpretation of alterations in the physicians ' psychoneuroendocrine structure in terms of impaired mood and neurocognitive deterioration combined with up - / dysregulated stress axes associated with OCD as a consequence of sleep deprivation .

###26040175
OBJECTIVE	Tooth loss affects oral health-related life quality .
OBJECTIVE	More than a third of edentulous patients are not fully satisfied with their complete dentures and mainly complain of insufficient stability , retention , and pain during mastication .
OBJECTIVE	Solving the problem may include relining by materials that are based on silicone or acrylic .
OBJECTIVE	The aim of this study was to determine the level of patients ' satisfaction before and after relining upper dentures with soft and rigid liners .
METHODS	The patients ( n = 24 ) were divided into two study groups .
METHODS	Maxillary denture relining of the first group of patients was performed with hard acrylic based resins while in the second group of patients complete denture was relined with a silicone-based soft liner .
METHODS	They were asked the questions from the specifically adapted the Oral Health Impact Profile Questionnaire for edentulous patients before and three months after relining dentures .
RESULTS	After relining the patients showed a higher degree of satisfaction with their dentures in all the tested domains ( masticatory function , psychological discomfort , social disability and retention and hygiene ) .
RESULTS	The padents with soft denture relines were more satisfied .
CONCLUSIONS	Refining of maxillary complete dentures significantly positively impacts the quality of life of patients in all the tested domains ( masticatory function , psychological discomfort , social disability , pain and oral hygiene ) .
CONCLUSIONS	Better results were achieved using a silicone-based soft liner , which recommends it as the material of choice for relining dentures .

###24471366
OBJECTIVE	Evidence that rider training reduces motorcycle-related injuries or crashes is currently lacking .
OBJECTIVE	However , significant community demand for training persists , which in turn can influence policy .
OBJECTIVE	The present study aims to contribute to the understanding of this demand via two objectives : to ( 1 ) offer a method , namely , contingent valuation , to measure the value motorcyclists place on training and ( 2 ) examine determinants of such value .
METHODS	Value was elicited through a willingness to question , using a bidding format , novice motorcyclists who were randomly assigned to groups either offered the training or not .
RESULTS	The group that was offered and subsequently received training provided a lower mean perceived value of the training than the group that was not .
RESULTS	Perceived value increased with rider age and decreased with training participation and near-crash experiences , controlling for bidding order , income , education , and experience of other training .
CONCLUSIONS	This study demonstrates the utility of contingent valuation in quantifying the perceived value of training , as well as the modifiability of perceived value , with age , training participation , and near-crash experiences as key determinants .
CONCLUSIONS	This indicates that research to determine ways to align the perceived value with evidence on training effectiveness is worthwhile in order to facilitate more appropriate and justified allocation of road safety resources .
CONCLUSIONS	Potential options to explore and evaluate may include community education on evidence of training effectiveness as well as alternative measures with demonstrated effectiveness in reducing crash risks .

###25651842
BACKGROUND	Earlier antiretroviral therapy ( ART ) initiation in cryptococcal meningitis resulted in higher mortality compared with deferred ART initiation ( 1-2 weeks vs 5 weeks postmeningitis diagnosis ) .
BACKGROUND	We hypothesized this was due to ART-associated immune pathology , without clinically recognized immune reconstitution inflammatory syndrome .
METHODS	Three macrophage activation markers and 19 cytokines/chemokines were measured from cryopreserved cerebrospinal fluid ( CSF ) and serum during the Cryptococcal Optimal ART Timing ( COAT ) trial .
METHODS	Comparisons were made between trial arms ( early vs deferred ) at 1 , 8 , 14 , and 21 days following meningitis diagnosis .
RESULTS	More participants with early ART initiation had CSF white cell count ( WCC ) 5/L at day 14 ( 58 % vs 40 % ; P = .047 ) , after a median of 6-days ART .
RESULTS	Differences were mainly driven by participants with CSF WCC < 5/L at meningitis diagnosis : 28 % ( 10/36 ) of such persons in the early ART group had CSF WCC 5/L by day 14 , compared with 0 % ( 0/27 ) in the deferred arm ( P = .002 ) .
RESULTS	Furthermore , Kampala participants ( the largest site ) receiving early ART had higher day-14 CSF levels of interleukin-13 ( P = .04 ) , sCD14 ( P = .04 ) , sCD163 ( P = .02 ) , and CCL3/MIP -1 ( P = .02 ) , suggesting increased macrophage/microglial activation .
CONCLUSIONS	Early ART initiation in cryptococcal meningitis increased CSF cellular infiltrate , macrophage/microglial activation , and T helper 2 responses within the central nervous system .
CONCLUSIONS	This suggests that increased mortality from early ART in the COAT trial was immunologically mediated .

###24717640
BACKGROUND	Bronchiectasis is characterised by chronic cough , sputum production , and recurrent chest infections .
BACKGROUND	Pathogenesis is poorly understood , but excess neutrophilic airway inflammation is seen .
BACKGROUND	Accumulating evidence suggests that statins have pleiotropic effects ; therefore , these drugs could be a potential anti-inflammatory treatment for patients with bronchiectasis .
BACKGROUND	We did a proof-of-concept randomised controlled trial to establish if atorvastatin could reduce cough in patients with bronchiectasis .
METHODS	Patients aged 18-79 years were recruited from a secondary-care clinic in Edinburgh , UK .
METHODS	Participants had clinically significant bronchiectasis ( ie , cough and sputum production when clinically stable ) confirmed by chest CT and two or more chest infections in the preceding year .
METHODS	Individuals were randomly allocated to receive either high-dose atorvastatin ( 80 mg ) or a placebo , given orally once a day for 6 months .
METHODS	Sequence generation was done with a block randomisation of four .
METHODS	Random allocation was masked to study investigators and patients .
METHODS	The primary endpoint was reduction in cough from baseline to 6 months , measured by the Leicester Cough Questionnaire ( LCQ ) score , with a lower score indicating a more severe cough ( minimum clinically important difference , 13 units ) .
METHODS	Analysis was done by intention-to-treat .
METHODS	The trial is registered with ClinicalTrials.gov , number NCT01299181 .
RESULTS	Between June 23 , 2011 , and Jan 30 , 2011 , 82 patients were screened for inclusion in the study and 22 were excluded before randomisation .
RESULTS	30 individuals were assigned atorvastatin and 30 were allocated placebo .
RESULTS	The change from baseline to 6 months in LCQ score differed between groups , with a mean change of 15 units in patients allocated atorvastatin versus -07 units in those assigned placebo ( mean difference 22 , 95 % CI 05-39 ; p = 001 ) .
RESULTS	12 ( 40 % ) of 30 patients in the atorvastatin group improved by 13 units or more on the LCQ compared with five ( 17 % ) of 30 in the placebo group ( difference 23 % , 95 % CI 1-45 ; p = 004 ) .
RESULTS	Ten ( 33 % ) patients assigned atorvastatin had an adverse event versus three ( 10 % ) allocated placebo ( difference 23 % , 95 % CI 3-43 ; p = 002 ) .
RESULTS	No serious adverse events were recorded .
CONCLUSIONS	6 months of atorvastatin improved cough on a quality-of-life scale in patients with bronchiectasis .
CONCLUSIONS	Multicentre studies are now needed to assess whether long-term statin treatment can reduce exacerbations .
BACKGROUND	Chief Scientist 's Office .

###25425697
BACKGROUND	An association between GB virus C ( GBV-C ) and improved outcomes of human immunodeficiency virus ( HIV ) infection has been reported in HIV-positive individuals with active GBV-C coinfection .
BACKGROUND	This study provides insights into the immune mechanisms underlying the protective role of GBV-C in HIV-infected patients .
METHODS	The concentrations of 64 cytokines and chemokines were measured in plasma samples obtained from the Viral Activation Transfusion Study cohort before transfusion and longitudinally from 30 patients positive for both HIV and GBV-C ( hereafter , `` cases '' ) and 30 patients positive for HIV and negative for GBV-C ( hereafter , `` controls '' ) .
RESULTS	Cases had lower HIV viral loads and higher CD4 T-cell counts than controls after acquisition of GBV-C infection .
RESULTS	Most of the modulated cytokines and chemokines were reduced after GBV-C detection , including many proinflammatory cytokines , suggesting an overall antiinflammatory effect of GBV-C in HIV-positive subjects .
RESULTS	Most pathways and functions of the measured cytokines were downregulated in cases , except cell death pathways , which were upregulated in various cell subsets in the 3 months after GBV-C detection .
CONCLUSIONS	GBV-C has a protective effect , in part through a competition mechanism leading to decreased inflammation and improved HIV disease outcome in cases .
CONCLUSIONS	Further studies are necessary to establish whether GBV-C may have deleterious effects on the host at the cellular level , including depleting the cells that are the targets of HIV .

###24931393
BACKGROUND	Atrial fibrillation and heart failure with reduced left ventricular ejection fraction have interrelated pathophysiologies .
BACKGROUND	New-onset atrial fibrillation in heart failure patients has been associated with increased mortality , but has not been definitively related to clinical heart failure progression .
METHODS	To test the hypothesis that new-onset atrial fibrillation is related to clinical heart failure progression , in 2392 patients without atrial fibrillation at randomization in the Beta-blocker Evaluation of Survival Trial we measured clinical endpoints in patients who did ( Group 1 , n = 190 ) or did not ( Group 2 , n = 2202 ) develop new-onset atrial fibrillation .
METHODS	Results were also compared with the 303 patients who entered the trial in atrial fibrillation ( Baseline/chronic group ) , and in Group 1/2 patients we conducted a multivariate analysis of covariates potentially related to time to first heart failure hospitalization .
RESULTS	Compared with Group 2 , Group 1 patients post atrial fibrillation onset had a 2-fold increase in mortality ( P < .0001 ) and a 4.5-fold increase in all-cause or heart failure hospitalization days/patient ( hospitalization burden , both P < .0001 ) .
RESULTS	In Group 1 , both types of hospitalization burden were 2.9-fold greater than in the Baseline/chronic group ( P < .001 ) , and hospitalization burden increased 6-fold ( P < .0001 ) compared with the pre-event period .
RESULTS	On multivariate analysis , new-onset atrial fibrillation was a highly significant ( P < .00001 ) predictor of heart failure hospitalization .
CONCLUSIONS	In addition to being a discrete electrophysiologic event , in heart failure patients , new-onset atrial fibrillation is a predictor of and trigger for clinical heart failure progression .

###24612502
BACKGROUND	Neoadjuvant endocrine therapy with an aromatase inhibitor has shown efficacy comparable to that of neoadjuvant chemotherapy in patients with postmenopausal breast cancer .
BACKGROUND	Preclinical and clinical studies have shown that the antidiabetic drug metformin has anti-tumor activity .
BACKGROUND	This prospective , multicenter , phase II randomized , placebo controlled trial was designed to evaluate the direct anti-tumor effect of metformin in non-diabetic postmenopausal women with estrogen-receptor ( ER ) positive breast cancer .
METHODS	Patients meeting the inclusion criteria and providing written informed consent will be randomized to 24 weeks of neoadjuvant treatment with letrozole ( 2.5 mg/day ) and either metformin ( 2000 mg/day ) or placebo .
METHODS	Target accrual number is 104 patients per arm .
METHODS	The primary endpoint will be clinical response rate , as measured by calipers .
METHODS	Secondary endpoints include pathologic complete response rate , breast conserving rate , change in Ki67 expression , breast density change , and toxicity profile .
METHODS	Molecular assays will be performed using samples obtained before treatment , at week 4 , and postoperatively .
CONCLUSIONS	This study will provide direct evidence of the anti-tumor effect of metformin in non-diabetic , postmenopausal patients with ER-positive breast cancer .
BACKGROUND	ClinicalTrials.gov Identifier NCT01589367 .

###24451697
OBJECTIVE	Investigate the effect of inhaling 1600 g salbutamol for 6 weeks on endurance , strength , and power performances .
METHODS	Randomized double-blind , mixed-model repeated measures .
METHODS	Sixteen male athletes ( mean SD : age , 20.1 1.6 years ; height , 179.9 8.2 cm ; weight , 74.6 9.1 kg ) .
METHODS	Participants were assigned to either a placebo inhaler ( PLA ) or inhaled 1600 g salbutamol group ( SAL ) .
METHODS	Over 6 weeks , participants inhaled PLA or SAL and completed 4 training sessions per week that focused on endurance , strength , and power .
METHODS	Participants completed the assessments of peak oxygen consumption ( V [ Combining Dot Above ] O2peak ) , 3-km time trial , vertical jump height , 1 repetition maximum ( 1RM ) bench and leg press , and peak torque knee flexion and extension .
METHODS	Assessments were undertaken at baseline , week 3 , and week 6 .
RESULTS	Over the 6 weeks , PLA and SAL groups improved V [ Combining Dot Above ] O2peak ( 51.7 4.7 vs 56.8 7.1 mLminkg ; 53.1 6.1 vs 55.0 6.7 mLminkg ) ; 3-km running time trial ( 988.6 194.6 vs 947.5 155.5 seconds ; 1040.4 187.4 vs 1004.2 199.4 seconds ) ; 1RM bench press ( 65.7 15.4 vs 70.3 13.8 kg ; 64.3 14.0 vs 72.5 15.3 kg ) ; and leg press ( 250.0 76.4 vs 282.5 63.6 kg ; 217.9 54.0 vs 282.8 51.9 kg ) .
RESULTS	The SAL group did not improve significantly greater in any endurance or strength and power measure when compared with the PLA group .
CONCLUSIONS	Inhaling 1600 g salbutamol daily over 6 weeks does not result in significant improvements in endurance , or strength and power performances .
CONCLUSIONS	Athletes using inhaled salbutamol to treat bronchoconstriction during exercise on a daily basis will not gain an advantage over nonasthmatic athletes not using inhaled salbutamol .

###24884854
BACKGROUND	Neurology is complex , abstract , and difficult for students to learn .
BACKGROUND	However , a good learning method for neurology clerkship training is required to help students quickly develop strong clinical thinking as well as problem-solving skills .
BACKGROUND	Both the traditional lecture-based learning ( LBL ) and the relatively new team-based learning ( TBL ) methods have inherent strengths and weaknesses when applied to neurology clerkship education .
BACKGROUND	However , the strengths of each method may complement the weaknesses of the other .
BACKGROUND	Combining TBL with LBL may produce better learning outcomes than TBL or LBL alone .
BACKGROUND	We propose a hybrid method ( TBL+LBL ) and designed an experiment to compare the learning outcomes with those of pure LBL and pure TBL .
METHODS	One hundred twenty-seven fourth-year medical students attended a two-week neurology clerkship program organized by the Department of Neurology , Sun Yat-Sen Memorial Hospital .
METHODS	All of the students were from Grade 2007 , Department of Clinical Medicine , Zhongshan School of Medicine , Sun Yat-Sen University .
METHODS	These students were assigned to one of three groups randomly : Group A ( TBL+LBL , with 41 students ) , Group B ( LBL , with 43 students ) , and Group C ( TBL , with 43 students ) .
METHODS	The learning outcomes were evaluated by a questionnaire and two tests covering basic knowledge of neurology and clinical practice .
RESULTS	The practice test scores of Group A were similar to those of Group B , but significantly higher than those of Group C.
RESULTS	The theoretical test scores and the total scores of Group A were significantly higher than those of Groups B and C.
RESULTS	In addition , 100 % of the students in Group A were satisfied with the combination of TBL+LBL .
CONCLUSIONS	Our results support our proposal that the combination of TBL+LBL is acceptable to students and produces better learning outcomes than either method alone in neurology clerkships .
CONCLUSIONS	In addition , the proposed hybrid method may also be suited for other medical clerkships that require students to absorb a large amount of abstract and complex course materials in a short period , such as pediatrics and internal medicine clerkships .

###25616294
OBJECTIVE	To study the short-term response and tolerance of different doses of amino acids in parenteral nutrition among preterm infants .
METHODS	This study included 86 preterm infants who had a birth weight between 1000 to 2000g and were admitted to the hospital within 24 hours of birth between March 2013 and June 2014 .
METHODS	According to the early application of different doses of amino acids , they were randomized into low-dose group ( n = 29 , 1.0 g/kg per day with an increase of 1.0 g/kg daily and a maximum of 3.5 g/kg per day ) , medium-dose group ( n = 28 , 2.0 g/kg per day with an increase of 1.0 g/kg daily and a maximum of 3.7 g/kg per day ) , and high-dose group ( n = 29 , 3.0 g/kg per day with an increase of 0.5-1 .0 g/kg daily and a maximum of 4.0 g/kg per day ) .
METHODS	Other routine parenteral nutrition and enteral nutrition support were also applied .
RESULTS	The maximum weight loss was lower and the growth rate of head circumference was greater in the high-dose group than in the low-dose group ( P < 0.05 ) .
RESULTS	The infants in the medium - and high-dose groups had faster recovery of birth weight , earlier attainment of 100 kcal / ( kgd ) of enteral nutrition , shorter duration of hospital stay , and less hospital cost than those in the low-dose group ( P < 0.05 ) .
RESULTS	Blood urea nitrogen ( BUN ) levels in the high-dose group increased compared with the other two groups 7 days after birth ( P < 0.05 ) .
RESULTS	The levels of creatinine , pH , bicarbonate , bilirubin , and transaminase and the incidence of complications showed no significant differences between groups ( P > 0.05 ) .
CONCLUSIONS	Parenteral administration of high-dose amino acids in preterm infants within 24 hours after birth can improve the short-term nutritional status of preterm infants , but there is a transient increase in BUN level .

###24647513
BACKGROUND	Prospective randomized studies comparing internal fixation and a cemented hip replacement in the treatment of displaced femoral neck fractures have shown favorable short-term results for prosthetic replacement .
BACKGROUND	The present report compares the results after a minimum of fifteen years .
METHODS	From 1994 to 1998 , 143 patients ( 146 hips ) were randomized to closed reduction and internal fixation with two screws ( n = 78 ) or a cemented total hip replacement ( n = 68 ) .
METHODS	The average age of the patients was eighty-four years ( range , seventy-five to 101 years ) , and 38 % were classified as mentally impaired .
METHODS	Failure after internal fixation was defined as early redisplacement , nonunion , symptomatic segmental collapse , or deep infection .
METHODS	In the arthroplasty group , failure was defined as two dislocations or more , implant loosening , deep infection , or a periprosthetic fracture .
RESULTS	For the lucid patients , the failure rate was 55 % after internal fixation compared with 5 % after total hip replacement .
RESULTS	For patients with mental impairment , it was 16 % in both groups .
CONCLUSIONS	Total hip replacement is superior to internal fixation in the treatment of a displaced femoral neck fracture .

###25642909
OBJECTIVE	Ultrasound-guided needle placement is a widely used technical skill that can be challenging to learn .
OBJECTIVE	The SonixGPS is a novel ultrasound needle-tracking system that has the potential to improve performance over traditional ultrasound systems .
OBJECTIVE	The objective of our study was to determine if the use of the SonixGPS ultrasound system improves performance of novice practitioners in ultrasound-guided needle placement compared with conventional ultrasound in the out-of-plane approach on a simulation model .
METHODS	Twenty-six medical students without previous ultrasound experience were randomized into 2 groups .
METHODS	Each group performed 30 simulated ultrasound nerve blocks on a porcine meat tissue simulation ( phantom ) model .
METHODS	Both groups used the SonixGPS ultrasound ; however , the study group had the needle-tracking system activated , whereas the control group did not .
METHODS	The participants were assessed for success rate , technical aspects of block performance , and certain behaviors that could compromise the quality of the block .
METHODS	Learning curves were developed to assess competence .
RESULTS	The needle guidance group reached competence more often .
RESULTS	This group had fewer attempts and quality-compromising behaviors than did those using conventional ultrasound .
CONCLUSIONS	Use of the SonixGPS ultrasound needle guidance system improves the performance of technical needling skills of novice trainees in an ex vivo model .
CONCLUSIONS	The place of this technology in the wider education of ultrasound-guided regional anesthesia remains to be established .

###25414250
OBJECTIVE	To compare a comprehensive lifestyle intervention for overweight children performed in groups of families with a conventional single-family treatment .
OBJECTIVE	Two-year follow-up data on anthropometric and psychological outcome are presented .
METHODS	Overweight and obese children aged 6-12years with body mass index ( BMI ) corresponding to 27.5 kg/m ( 2 ) in adults were randomised to multiple-family ( n = 48 ) or single-family intervention ( n = 49 ) in a parallel design .
METHODS	Multiple-family intervention comprised an inpatient programme with other families and a multidisciplinary team , follow-up visits in their hometown , weekly physical activity and a family camp .
METHODS	Single-family intervention included counselling by paediatric nurse , paediatric consultant and nutritionist at the hospital and follow-up by a community public health nurse .
METHODS	Primary outcome measures were change in BMI kg/m ( 2 ) and BMI SD score after 2years .
RESULTS	BMI increased by 1.29 kg/m ( 2 ) in the multiple-family intervention compared with 2.02 kg/m ( 2 ) in the single-family intervention ( p = 0.075 ) .
RESULTS	BMI SD score decreased by 0.20 units in the multiple-family group and 0.08 units in the single-family intervention group ( p = 0.046 ) .
RESULTS	A between-group difference of 2.4 cm in waist circumference ( p = 0.038 ) was detected .
RESULTS	Pooled data from both treatment groups showed a significant decrease in BMI SD score of 0.14 units and a significant decrease in parent-reported and self-reported Strength and Difficulty Questionnaire total score of 1.9 units .
CONCLUSIONS	Two-year outcome showed no between-group difference in BMI .
CONCLUSIONS	A small between-group effect in BMI SD score and waist circumference favouring multiple-family intervention was detected .
CONCLUSIONS	Pooled data showed an overall improvement in psychological outcome measures and BMI SD score .
BACKGROUND	NCT00872807 , http://www.clinicaltrials.gov .

###25477057
OBJECTIVE	Patients can potentially monitor disease activity of RA through self-assessed swollen joints ( clinical synovitis ) , but reliability is poor .
OBJECTIVE	The objective is to evaluate the use of education by US feedback on the ability of patients to assess for clinical synovitis in RA .
METHODS	We performed a 6 month , single-centre , randomized controlled trial on patients with established RA to study the effect of education on self-assessment of joints that included initial brief patient training on tender ( TJC ) and swollen ( SJC ) joint counts followed by US feedback every 3 months vs standard care without education .
METHODS	Patient and physician independently performed 28-joint counts at each visit .
METHODS	Outcome variables included the percentage of patients with good agreement with physician-derived swollen joints [ prevalence-adjusted bias-adjusted kappa ( PABAK ) > 0.6 ] as well as agreement in the SJC ( Bland and Altman 95 % limits of agreement ) , feasibility/patient satisfaction survey and disease activity at 6 months .
RESULTS	Of the 101 randomized patients , 95 were included ( 51 in the education arm and 44 in the standard care arm ) .
RESULTS	At 6 months there was a significant difference in the proportion of patients with swollen joint PABAK > 0.6 in the education arm compared with standard care ( 98 vs 85 % , P = 0.02 ) .
RESULTS	Limits of agreement for the SJC difference between physician and patients were reduced only in the education arm .
RESULTS	The training method is considered feasible , with 94 % of patients reporting it as useful .
RESULTS	A trend of higher rates of disease remission ( 28-joint DAS < 2.6 ) in the education arm vs standard care ( 47 % vs 29 % , P = 0.07 ) was seen .
CONCLUSIONS	A short course of education with US feedback may be helpful in educating patients to assess for clinical synovitis .
BACKGROUND	Clinical trials.gov , https://clinicaltrials.gov , NCT02351401 .

###25155416
BACKGROUND	Transient lower esophageal sphincter relaxation ( TLESR ) is the major mechanism of gastroesophageal reflux ( GER ) but the regulation of TLESR by stimuli in the esophagus is incompletely understood .
BACKGROUND	If stimuli in the esophagus can influence TLESR , then such regulation may perpetuate or limit GER .
BACKGROUND	We addressed the hypothesis that acid in the esophagus enhances TLESRs .
METHODS	We evaluated the effect of acid infusion into the distal esophagus on TLESRs evoked by a standard meal in a paired randomized study in healthy subjects .
METHODS	TLESRs were evaluated by using high resolution manometry ( HRM ) .
RESULTS	We found that acid in the esophagus enhanced meal-induced TLESRs .
RESULTS	Compared to control infusion the number of TLESRs ( median [ interquartile range ] ) was increased during 2h following the acid infusion ( 11 [ 9-14 ] vs 17 [ 12.5-20 ] , p < 0.01 ) .
RESULTS	The average duration of individual TLESRs was not affected .
RESULTS	The time-course analysis revealed that a robust increase in TLESRs occurred already in the first hour when the number of TLESRs nearly doubled ( 6 [ 5.5-7 .5 ] vs 11 [ 7.5-12 .5 ] , p < 0.05 ) .
RESULTS	In contrast to the enhancement of TLESRs , the number of swallows was not changed .
CONCLUSIONS	The acid infusion into the esophagus increases the number of meal-induced TLESRs in healthy subjects .
CONCLUSIONS	Our results provide evidence for the concept that the stimuli in the esophagus can influence TLESRs .
CONCLUSIONS	The regulation of TLESR by stimuli in the esophagus may contribute to pathogenesis of GER in some patients .

###24285844
BACKGROUND	Previously we conducted a double-blind controlled , randomized efficacy field trial of gD-2 HSV vaccine adjuvanted with ASO4 in 8323 women .
BACKGROUND	Subjects had been previously selected to be seronegative for HSV-1 and HSV-2 .
BACKGROUND	We found that vaccine was 82 % protective against HSV-1 genital disease , but offered no significant protection against HSV-2 genital disease .
METHODS	To better understand the results of the efficacy study , post-vaccination anti-gD-2 antibody concentrations from all HSV infected subjects and matched uninfected controls were measured .
METHODS	Three models were used to determine whether thes responses correlated with protection against HSV infection or disease .
METHODS	Similarly , cellular immune responses from a subset of subjects and matched controls were evaluated for a correlation with HSV protection .
RESULTS	Antibodies to gD-2 correlated with protection against HSV-1 infection with higher antibody concentration associated with higher efficacy .
RESULTS	Cellular immune responses to gD-2 did not correlate with protection .
CONCLUSIONS	The protection against HSV-1 infection observed in the Herpevac Trial for Women was associated with antibodies directed against the vaccine .
CONCLUSIONS	Clinical Trials RegistrationNCT00057330 .

###24364795
OBJECTIVE	People with substance use disorders who present with suicidal behavior are at high risk of subsequent suicide .
OBJECTIVE	There are few effective treatments specifically tailored for this population that diminish this risk .
OBJECTIVE	We aimed to assess the impact of an opportunistic cognitive behavioral intervention package ( OCB ) among adult outpatients with a substance use and comorbid suicide risk .
METHODS	A randomized controlled trial was conducted across 2 sites in which 185 patients presenting with suicide risk and concurrent substance use received either OCB ( 8 sessions plus group therapy ) or treatment as usual ( TAU ) over a 6-month period .
METHODS	Primary outcomes were suicidal behavior ( suicide attempts , suicidal intent and presence of suicide ideation ) and level of drug and alcohol consumption .
METHODS	Secondary outcomes were changes in psychological measures of suicide ideation , depression , anxiety , and self-efficacy .
RESULTS	There were no completed suicides , and only 2 participants reported suicide attempts at follow-up .
RESULTS	Suicide ideation , alcohol consumption , and cannabis use fell over time but no significant Treatment Time differences were found .
RESULTS	There were also no differences between OCB and TAU over time on psychological measures of depression , anxiety , or self-efficacy .
RESULTS	Suicide ideation at 6-month follow-up was predicted by cannabis use and higher scores on the Brief Psychiatric Rating Scale at baseline .
CONCLUSIONS	The opportunistic cognitive behavioral intervention package did not appear to be beneficial in reducing suicide ideation , drug and alcohol consumption , or depression relative to treatment as usual .

###25203878
OBJECTIVE	To compare bariatric surgery versus intensive medical weight management ( MWM ) in patients with type 2 diabetes mellitus ( T2DM ) who do not meet current National Institutes of Health criteria for bariatric surgery and to assess whether the soluble form of receptor for advanced glycation end products ( sRAGE ) is a biomarker to identify patients most likely to benefit from surgery .
BACKGROUND	There are few studies comparing surgery to MWM for patients with T2DM and BMI less than 35 .
METHODS	Fifty-seven patients with T2DM and BMI 30 to 35 , who otherwise met the criteria for bariatric surgery were randomized to MWM versus surgery ( bypass , sleeve or band , based on patient preference ) .
METHODS	The primary outcomes assessed at 6 months were change in homeostatic model of insulin resistance ( HOMA-IR ) and diabetes remission .
METHODS	Secondary outcomes included changes in HbA1c , weight , and sRAGE .
RESULTS	The surgery group had improved HOMA-IR ( -4.6 vs +1.6 ; P = 0.0004 ) and higher diabetes remission ( 65 % vs 0 % , P < 0.0001 ) than the MWM group at 6 months .
RESULTS	Compared to MWM , the surgery group had lower HbA1c ( 6.2 vs 7.8 , P = 0.002 ) , lower fasting glucose ( 99.5 vs 157 ; P = 0.0068 ) , and fewer T2DM medication requirements ( 20 % vs 88 % ; P < 0.0001 ) at 6 months .
RESULTS	The surgery group lost more weight ( 7 .
RESULTS	vs 1.0 BMI decrease , P < 0.0001 ) .
RESULTS	Higher baseline sRAGE was associated with better weight loss outcomes ( r = -0.641 ; P = 0.046 ) .
RESULTS	There were no mortalities .
CONCLUSIONS	Surgery was very effective short-term in patients with T2DM and BMI 30 to 35 .
CONCLUSIONS	Baseline sRAGE may predict patients most likely to benefit from surgery .
CONCLUSIONS	These findings need to be confirmed with larger studies.ClinicalTrials.gov ID : NCT01423877 .

###25180279
OBJECTIVE	Susceptibility to encapsulated bacteria is well known in sickle cell disease ( SCD ) .
OBJECTIVE	Hydroxyurea use is common in adults and children with SCD , but little is known about hydroxyurea 's effects on immune function in SCD .
OBJECTIVE	Because hydroxyurea inhibits ribonucleotide reductase , causing cell cycle arrest at the G1-S interface , we postulated that hydroxyurea might delay transition from naive to memory T cells , with inhibition of immunologic maturation and vaccine responses .
METHODS	T-cell subsets , naive and memory T cells , and antibody responses to pneumococcal and measles , mumps , and rubella vaccines were measured among participants in a multicenter , randomized , double-blind , placebo-controlled trial of hydroxyurea in infants and young children with SCD ( BABY HUG ) .
RESULTS	Compared with placebo , hydroxyurea treatment resulted in significantly lower total lymphocyte , CD4 , and memory T-cell counts ; however , these numbers were still within the range of historical healthy controls .
RESULTS	Antibody responses to pneumococcal vaccination were not affected , but a delay in achieving protective measles antibody levels occurred in the hydroxyurea group .
RESULTS	Antibody levels to measles , mumps , and rubella showed no differences between groups at exit , indicating that effective immunization can be achieved despite hydroxyurea use .
CONCLUSIONS	Hydroxyurea does not appear to have significant deleterious effects on the immune function of infants and children with SCD .
CONCLUSIONS	Additional assessments of lymphocyte parameters of hydroxyurea-treated children may be warranted .
CONCLUSIONS	No changes in current immunization schedules are recommended ; however , for endemic disease or epidemics , adherence to accelerated immunization schedules for the measles , mumps , and rubella vaccine should be reinforced .

###25935101
OBJECTIVE	To evaluate acupuncture as treatment for glaucoma .
METHODS	Prospective double-masked randomized crossover study .
METHODS	setting : Clinical practice .
METHODS	One eye per patient with primary open-angle glaucoma and stable intraocular pressure ( IOP ) .
METHODS	Patients were randomized to receive 1 acupuncture series ( 12 sessions with either eye-related [ eye-points ] or non-eye-related [ non-eye-points ] acupoints ) and then crossed over to receive the other series .
METHODS	IOP , blood pressure ( BP ) , heart rate ( HR ) , best-corrected visual acuity ( BCVA ) , visual field ( VF ) , optic disc and peripapillary retinal nerve fiber layer ( RNFL ) measurements , compliance , and adverse reactions .
METHODS	Probability to detect 3 mm Hg IOP difference between series was 90 % .
RESULTS	Twenty-two patients volunteered and 11 ( 50.0 % ) completed the study ; 8 ( 36.4 % ) did not complete treatment owing to changes of health , moving away , lack of transportation , or family crisis ; and 3 ( 13.6 % ) were withdrawn owing to needle sensitivity or IOP elevation ( 8 mm Hg ) in the contralateral eye .
RESULTS	After an acupuncture session , mean IOP increased slightly with both eye-points ( from 12.9 1.8 mm Hg to 13.6 2.0 mm Hg , P = .019 ) and non-eye-points ( from 13.0 1.5 mm Hg to 13.5 1.7 mm Hg , P = .073 ) series .
RESULTS	HR , diurnal IOP , and BCVA showed no statistically significant changes after 12 sessions of either series .
RESULTS	Systolic and diastolic BP were reduced after 12 sessions of non-eye-points series ( P = .040 , P = .002 , respectively ) .
RESULTS	Optic disc , RNFL , and VF showed no statistically significant changes .
CONCLUSIONS	Acupuncture has no overall effect on diurnal IOP or BCVA but may temporally increase the IOP immediately after a treatment session .
CONCLUSIONS	BP is lowered by acupuncture with non-eye-points , but not with eye-points .
CONCLUSIONS	Compliance and adverse event rates were low .

###24574190
OBJECTIVE	Scarce data are available on the effect of the traditional Mediterranean diet ( TMD ) on heart failure biomarkers .
OBJECTIVE	We assessed the effect of TMD on biomarkers related to heart failure in a high cardiovascular disease risk population .
RESULTS	A total of 930 subjects at high cardiovascular risk ( 420 men and 510 women ) were recruited in the framework of a multicentre , randomized , controlled , parallel-group clinical trial directed at testing the efficacy of the TMD on the primary prevention of cardiovascular disease ( The PREDIMED Study ) .
RESULTS	Participants were assigned to a low-fat diet ( control , n = 310 ) or one of two TMDs [ TMD + virgin olive oil ( VOO ) or TMD + nuts ] .
RESULTS	Depending on group assignment , participants received free provision of extra-virgin olive oil , mixed nuts , or small non-food gifts .
RESULTS	After 1year of intervention , both TMDs decreased plasma N-terminal pro-brain natriuretic peptide , with changes reaching significance vs. control group ( P < 0.05 ) .
RESULTS	Oxidized low-density lipoprotein decreased in both TMD groups ( P < 0.05 ) , the decrease in TMD+VOO group reaching significance vs. changes in control group ( P = 0.003 ) .
RESULTS	Changes in lipoprotein ( a ) after TMD+VOO were less than those in the control group ( P = 0.046 ) in which an increase ( P = 0.035 ) was observed .
RESULTS	No changes were observed in urinary albumin or albumin/creatinine ratio .
CONCLUSIONS	Individuals at high risk of cardiovascular disease ( CVD ) who improved their diet toward a TMD pattern reduced their N-terminal pro-brain natriuretic peptide compared with those assigned to a low-fat diet .
CONCLUSIONS	The same was found for in vivo oxidized low-density lipoprotein and lipoprotein ( a ) plasma concentrations after the TMD+VOO diet .
CONCLUSIONS	From our results TMD could be a useful tool to mitigate against risk factors for heart failure .
CONCLUSIONS	From our results TMD could modify markers of heart failure towards a more protective mode .

###26091594
BACKGROUND	Previous qualitative research among adults and parents of children with phenylketonuria ( PKU ) has identified inattention as an important psychiatric aspect of this condition .
BACKGROUND	The parent-reported ADHD Rating Scale-IV ( ADHD RS-IV ) and the Adult ADHD Self-Report Scale ( ASRS ) have been validated for measuring inattention symptoms in persons with attention-deficit/hyperactivity disorder ( ADHD ) ; however , their psychometric attributes for measuring PKU-related inattention have not been established .
OBJECTIVE	The primary objective of this investigation was to demonstrate the reliability , validity , and responsiveness of the ADHD RS-IV and ASRS inattention symptoms subscales in a randomized controlled trial of patients with PKU aged 8 years or older .
METHODS	A post hoc analysis investigated the psychometric properties ( Rasch model fit , reliability , construct validity , and responsiveness ) of the ADHD RS-IV and ASRS inattention subscales using data from a phase 3b , double-blind , placebo-controlled clinical trial in those with PKU aged 8 years or older .
RESULTS	The Rasch results revealed good model fit , and reliability analyses revealed strong internal consistency reliability ( 0.87 ) and reproducibility ( intraclass correlation coefficient 0.87 ) for both measures .
RESULTS	Both inattention measures demonstrated the ability to discriminate between known groups ( P < 0.001 ) created by the Clinical Global Impression-Severity scale .
RESULTS	Correlations between the ADHD RS-IV and the ASRS with the Clinical Global Impression-Severity scale and the age-appropriate Behavior Rating Inventory of Executive Function Working Memory subscale were consistently moderate to strong ( r 0.56 ) .
RESULTS	Similarly , results of the change score correlations were of moderate magnitude ( r 0.43 ) for both measures when compared with changes over time in Behavior Rating Inventory of Executive Function Working Memory subscales .
CONCLUSIONS	These findings of reliability , validity , and responsiveness of both the ADHD RS-IV and the ASRS inattention scales , in addition to content validation results , support their use for the assessment of inattention symptoms among persons with PKU aged 8 years or older in both clinical and research settings .

###25190072
OBJECTIVE	To evaluate the relationship between lipid content and plaque morphometry as well as the process of lesion progression and regression in patients with significant coronary artery disease .
RESULTS	The present study , using data from the YELLOW trial , was conducted in patients having significant coronary lesions ( fractional flow reserve < 0.8 ) who underwent serial intravascular ultrasound ( IVUS ) and near-infrared spectroscopy ( NIRS ) at baseline and after 7 weeks .
RESULTS	For each coronary plaque ( 50 % plaque burden that was 5 mm in length ) , we evaluated plaque characteristics and the extent of lipid-rich plaque [ LRP , defined as the 4 mm long segment with the maximum lipid-core burden index ( maxLCBI4 mm ) ] on NIRS .
RESULTS	Among 66 patients ( age 63.0 10.1 years ; 82 % statin use at baseline ) , 94 plaques were identified .
RESULTS	The extent of LRP at baseline was positively correlated with IVUS plaque burden ( r = 0.317 , P = 0.002 ) .
RESULTS	A large LRP ( maxLCBI4 mm 500 ) was present only in plaques with a large plaque burden ( 70 % ) .
RESULTS	Multivariate analysis demonstrated that plaque burden was the best predictor of the extent of LRP ( P < 0.001 ) .
RESULTS	In lesions with a large plaque burden and a large amount of LRP at baseline , a reduction in LRP was seen in all lesions in patients receiving intensive statin therapy ( P = 0.004 ) without a significant change in plaque burden .
CONCLUSIONS	Coronary lesions containing a large amount of LRP also had a large plaque burden .
CONCLUSIONS	Short-term regression of LRP ( without a change in plaque burden ) was observed mainly in plaques with a large plaque burden and a large amount of LRP at baseline .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01567826 .

###25043647
BACKGROUND	High blood pressure is common in acute stroke and associated with a worse functional outcome .
BACKGROUND	Many patients who present with acute stroke are taking prescribed antihypertensive therapy before their stroke .
OBJECTIVE	ENOS tested whether lowering blood pressure and continuing pre-stroke antihypertensive therapy are each safe and effective .
METHODS	This study is an international multi-centre prospective randomized single-blind blinded-endpoint parallel-group partial-factorial controlled trial of transdermal glyceryl trinitrate ( a nitric oxide donor , given for seven-days ) vs. no glyceryl trinitrate , and of continuing vs. stopping ( temporarily for seven-days ) pre-stroke antihypertensive drugs if relevant , inpatients with acute ischaemic stroke or intracerebral haemorrhage and high systolic blood pressure ( 140220 mmHg ) .
RESULTS	Recruitment ran from July 2001 to October 2013 .
RESULTS	Four thousand eleven patients [ 2097 ( 523 % ) in the continue/stop arm ] were recruited from 173 sites across 23 countries in 5 continents ( Asia 14 % , Continental Europe 16 % , UK 64 % ) .
RESULTS	Baseline characteristics include : mean age 70 ( standard deviation 12 ) years ; male 57 % ; mean time from stroke to recruitment 26 ( 13 ) h ; mean severity ( Scandinavian Stroke Scale ) 34 ( 13 ) of 58 ; mean blood pressure 167 ( 19 ) / 90 ( 13 ) mmHg ; ischaemic stroke 83 % ; and intracerebral haemorrhage 16 % .
RESULTS	The main trial results will be presented in May 2014 .
RESULTS	The results will also be presented in updated Cochrane systematic reviews and included in individual patient data meta-analyses of all relevant randomized controlled trials .
CONCLUSIONS	ENOS is a large completed international trial of blood pressure management in acute stroke and includes patients representative of many stroke services worldwide .

###25046032
OBJECTIVE	To assess the role of pelvic plexus block ( PPB ) in reducing pain during transrectal ultrasonography ( TRUS ) - guided prostate biopsy , compared with the conventional periprostatic nerve block ( PNB ) .
METHODS	A prospective , double-blind observational study was conducted with patients being randomised into three groups .
METHODS	Group-1 ( 47 patients ) received intrarectal local anaesthesia ( IRLA ) with 10 mL 2 % lignocaine jelly along with pelvic plexus block ( PPB ) with 2.5 mL 2 % lignocaine injection bilaterally .
METHODS	Group-2 ( 46 patients ) received IRLA with periprostatic nerve block ( PNB ) .
METHODS	Group-3 ( 46 patients ) received only IRLA without any type of nerve block .
METHODS	The patients were requested to rate the level of pain from 0 to 10 on a visual analogue scale ( VAS ) at two time points : VAS-1 : during biopsy procedure and VAS-2 : 30 min after the procedure .
RESULTS	The mean age of the patients , mean volume of the prostates and mean serum PSA values were comparable among the three groups .
RESULTS	The mean pain score during biopsy was significantly less in the PPB group [ mean ( range ) sore of 2.91 ( 2-4 ) ] compared with the PNB group [ mean ( range ) score of 4 ( 3-5 ) ] , and both these groups were superior to the no nerve block group [ mean score of 5.4 ( 3-7 ) ] .
RESULTS	There was no significant difference between the mean pain scores , 30 min after the procedure among the three groups with the mean ( range ) scores being 2.75 ( 2-4 ) , 2.83 ( 2-4 ) and 2.85 ( 2-4 ) , respectively .
CONCLUSIONS	PPB is superior to conventional periprostatic nerve block ( PNB ) for pain control during TRUS-guided biopsy and both are in turn superior to no nerve block .

###25300721
OBJECTIVE	To study the effects of four different rigid alignment approaches on both time-concentration curves ( TCCs ) and perfusion maps in computed tomography perfusion ( CTp ) studies of liver and lung tumors .
METHODS	Eleven data sets in patients who were subjected to axial CTp after contrast agent administration were assessed .
METHODS	Each data set consists of four different sequences , according to the different rigid alignment configurations considered to compute blood flow perfusion maps : no alignment , translational , craniocaudal , and three dimensional ( 3D ) .
METHODS	The color maps were built on TCCs according to the maximum slope method .
METHODS	The effects of motion correction procedures on the reliability of TCCs and perfusion maps were assessed both quantitatively and visually .
RESULTS	TCCs built after 3D alignments show the best indices as well as producing the most reliable maps .
RESULTS	We show examinations in which the translational alignment only yields more accurate TCCs , but less reliable perfusion maps , than those achieved with no alignment .
RESULTS	Furthermore , we show color maps with two different perfusion patterns , both considered reliable by radiologists , achieved with different motion correction approaches .
CONCLUSIONS	The quantitative index we conceived allows relating quality of 3D alignment and reliability of perfusion maps .
CONCLUSIONS	A better alignment does not necessarily yield more reliable perfusion values : color maps resulting from either alignment procedure must be critically assessed by radiologists .
CONCLUSIONS	This achievement will hopefully represent a step forward for the clinical use of CTp studies for staging , prognosis , and monitoring values of therapeutic regimens .

###24290858
BACKGROUND	The purpose of this study was to explore the effectiveness and safety of three-dimensional ( 3D ) digitalized planning for the sural neurovascular island flap in repair of soft tissue defects in the ankle and foot .
METHODS	This study included 40 patients with soft tissue defects of the ankle and foot who underwent soft tissue reconstruction between October 2008 and June 2012 .
METHODS	The patients were randomly assigned into two groups : 3D-reconstruction group ( Group A , n = 20 ) and control group ( Group B , n = 20 ) .
METHODS	Three-dimensional , digitalized virtual planning was performed in the patients in Group A , who underwent computed topographic angiography .
METHODS	The survival rate , operation time , and surgical accuracy were compared between the two groups .
RESULTS	All flaps in Group A survived and the recipient site primarily healed , but 4 flaps in Group B had marginal necrosis after the operation .
RESULTS	During the 6-12 month follow-up period , all flaps in Group A had good skin quality .
RESULTS	In Group B , hard scarring and mild contracture occurred in 4 cases , and the patients experienced pain when walking .
RESULTS	The survival rate of the flap in Group A ( 100 % ) was significantly higher than in Group B ( 70 % ) .
RESULTS	The operation time in Group A was significantly less than in Group B.
RESULTS	The surgical accuracy in Group A was significantly better than in Group B.
CONCLUSIONS	The preoperative use of 3D digitalized virtual planning for the sural neurovascular island flap improves the surgical accuracy , decreases the operation time , and increases the survival rate of the flap .
METHODS	Therapeutic III .

###25367713
OBJECTIVE	To evaluate clinical remission with subcutaneous abatacept plus methotrexate ( MTX ) and abatacept monotherapy at 12months in patients with early rheumatoid arthritis ( RA ) , and maintenance of remission following the rapid withdrawal of all RA treatment .
METHODS	In the Assessing Very Early Rheumatoid arthritis Treatment phase 3b trial , patients with early active RA were randomised to double-blind , weekly , subcutaneous abatacept 125mg plus MTX , abatacept 125mg monotherapy , or MTX for 12months .
METHODS	Patients with low disease activity ( Disease Activity Score ( DAS ) 28 ( C reactive protein ( CRP ) ) < 3.2 ) at month 12 entered a 12-month period of withdrawal of all RA therapy .
METHODS	The coprimary endpoints were the proportion of patients with DAS28 ( CRP ) < 2.6 at month 12 and both months 12 and 18 , for abatacept plus MTX versus MTX .
RESULTS	Patients had < 2years of RA symptoms , DAS28 ( CRP ) 3.2 , anticitrullinated peptide-2 antibody positivity and 95.2 % were rheumatoid factor positive .
RESULTS	For abatacept plus MTX versus MTX , DAS28 ( CRP ) < 2.6 was achieved in 60.9 % versus 45.2 % ( p = 0.010 ) at 12months , and following treatment withdrawal , in 14.8 % versus 7.8 % ( p = 0.045 ) at both 12 and 18months .
RESULTS	DAS28 ( CRP ) < 2.6 was achieved for abatacept monotherapy in 42.5 % ( month 12 ) and 12.4 % ( both months 12 and 18 ) .
RESULTS	Both abatacept arms had a safety profile comparable with MTX alone .
CONCLUSIONS	Abatacept plus MTX demonstrated robust efficacy compared with MTX alone in early RA , with a good safety profile .
CONCLUSIONS	The achievement of sustained remission following withdrawal of all RA therapy suggests an effect of abatacept 's mechanism on autoimmune processes .
BACKGROUND	NCT01142726 .

###24842494
BACKGROUND	Sealing of the femoral canal , usually with autologous bone , is a surgical procedure that is often performed during TKA surgery to decrease blood loss in the postoperative period .
BACKGROUND	However , evidence as to the effectiveness of this surgical procedure is not conclusive .
BACKGROUND	The objective of this study was to assess the effectiveness of this surgical action in reducing postoperative blood loss and the blood transfusion rate .
METHODS	A randomized prospective study that included 201 TKAs divided into three groups ( 67 in each one ) was carried out .
METHODS	The three groups were ; A ) bone graft sealing , B ) cement sealing and C ) unsealed canal .
METHODS	All groups were comparable with regard to pre and intra-operative data .
METHODS	The haemoglobin decrease at 2 , 24 and 72 h was compared to the preoperative haemoglobin value .
METHODS	Subsequently , blood drainage at 12 and 24h and the rate of blood transfusion were also assessed .
METHODS	The different complications that arose were reported .
RESULTS	No statistical differences were obtained with regard to blood drainage at 12h ( p = 0.102 ) and 24h ( p = 0.542 ) , the haemoglobin value decrease at 72 h ( p = 0.95 ) and the number of blood transfusions ( p = 0.597 ) in the three groups studied .
CONCLUSIONS	There was no significant difference , whether sealing the femoral canal with a bone graft , cement or when it was left unsealed , in decreasing blood loss or blood transfusion requirements in the postoperative period .
METHODS	Therapeutic type I.

###24494279
OBJECTIVE	To observe the clinical efficacy and safety of electroacupuncture ( EA ) combined with herbal acupoint sticking in the treatment of Bell 's palsy and provide optimizations for the clinic .
METHODS	One hundred and two cases of Bell 's palsy were randomized into an EA combined with herbal acupoint sticking group ( group A , 50 cases ) and an EA group ( group B , 52 cases ) , EA at Cuanzhu ( BL 2 ) , Yangbai ( GB 14 ) , Taiyang ( EX-HN 5 ) , Quanliao ( SI 18 ) , Xiaguan ( ST 7 ) , Yingxiang ( LI 20 ) , etc. were applied in both groups and `` facial paralys No.I '' was applied at Yifeng ( TE 17 ) in group A , once daily and 10 times totally were needed .
METHODS	The score of facial nerve function , clinical efficacy were compared before and after treatment .
METHODS	At 1 and 3 month follow up visit , the quality of life scale ( WHOQOL-BREF ) and the occurrence of complication were observed .
RESULTS	The scores of facial nerve function in group A and group B were all significantly improved compared with those before treatment ( 48.2 + / - 2.9 vs 25.7 + / - 4.9 , 45.9 + / - 6.2 vs 25.8 + / - 5.5 , both P < O. 01 ) , the cured rate in group A [ 82.0 % ( 41/50 ) ] were significantly superior to that in group B [ 67.3 % ( 35/52 ) ] ( P < 0.05 ) ; the difference of WHOQOL-BREF in both groups at 1 and 3 month follow up visit was not significant ( all P > 0.05 ) .
RESULTS	The occurrence of complication in group A ( 1 case ) was significantly less than that in group B ( 8 cases , P 0.05 ) .
CONCLUSIONS	Compared with EA , the combination of EA and acupoint sticking therapy for Bell 's palsy can not only improve the clinical efficacy and reduce the occurrence of complication but also reliable without any side effect .

###24615171
OBJECTIVE	The combination of dutasteride and tamsulosin may be more effective for the treatment of symptomatic benign prostatic hyperplasia than either treatment alone .
OBJECTIVE	We report the results of three pharmacokinetics and tolerability studies , which used a dutasteride/tamsulosin HCl ( 0.5 mg/0 .2 mg ) fixed-dose combination ( FDC ) capsules containing a small dutasteride soft gelatin capsule ( smaller than commercial Avodart ) and modified-release tamsulosin pellets that have different amounts of enteric coating .
OBJECTIVE	These studies compared the test products to commercial Avodart ( dutasteride 0.5 mg ) and two different commercial tamsulosin HCl 0.2 mg products , Harnal Capsules or Harnal-D Tablets , which are reportedly bioequivalent to each other .
METHODS	All three studies were randomized single-dose studies in healthy male adults .
METHODS	Study 1 [ N = 86 ( NCT01254071 ) ] was a two-period crossover study of a dutasteride/tamsulosin HCl FDC versus coadministered Avodart and Harnal-D Tablets .
METHODS	The pharmacokinetics of both dutasteride and tamsulosin were studied .
METHODS	Study 2 [ N = 27 ( NCT01471678 ) ] was a four-period crossover study of dutasteride/tamsulosin HCl FDC formulations versus Avodart and Harnal Capsules or Harnal-D Tablets .
METHODS	Only the pharmacokinetics of tamsulosin were studied .
METHODS	Study 3 [ N = 40 ( NCT01495026 ) ] was a two-period study of dutasteride/tamsulosin HCl FDC formulations versus coadministered Avodart and Harnal-D Tablets .
METHODS	In this study , only the pharmacokinetics of tamsulosin were studied .
METHODS	Study 2 assessed fed-state pharmacokinetics .
METHODS	Studies 1 and 3 assessed fed - and fasted-state pharmacokinetics .
RESULTS	All dutasteride/tamsulosin HCl FDC formulations and coadministered treatments were well-tolerated .
RESULTS	In Study1 , the FDC dutasteride was bioequivalent to Avodart coadministered with tamsulosin under fed and fasted conditions .
RESULTS	In Study1 , the FDC tamsulosin had a slower release than commercial Harnal-D Tablets coadministered with dutasteride ( fed and fasted state ) .
RESULTS	In Study2 , the FDC tamsulosin containing 15 % by weight enteric-coated tamsulosin pellets was bioequivalent to Harnal Capsules coadministered with dutasteride in the fed state .
RESULTS	In Study3 , the FDC containing 15 % by weight enteric-coated tamsulosin pellets combined with uncoated tamsulosin pellets ( coated : uncoated = 10:90 ) were bioequivalent to Harnal-D Tablets coadministered with dutasteride in the fasted state but not the fed state .
CONCLUSIONS	The FDC formulations were well-tolerated and some FDC formulations were comparable with concomitant administration of commercially available dutasteride and tamsulosin .

###24628650
BACKGROUND	GastroGard , an omeprazole powder paste formulation , is considered the standard treatment for gastric ulcers in horses and is highly effective .
BACKGROUND	Gastrozol , an enteric-coated omeprazole formulation for horses , has recently become available , but efficacy data are controversial and sparse .
OBJECTIVE	To investigate the efficacy of GastroGard and Gastrozol at labeled doses ( 4 and 1 mg of omeprazole per kg bwt , respectively , PO q24h ) in healing of gastric ulcers .
METHODS	40 horses ; 9.5 4.6 years ; 491 135 kg .
METHODS	Prospective , randomized , blinded study .
METHODS	Horses with an ulcer score 1 ( Equine Gastric Ulcer Council ) were randomly divided into 2 groups and treated for 2 weeks each with GastroGard followed by Gastrozol ( A ) or vice versa ( B ) .
METHODS	After 2 and 4 weeks , scoring was repeated and compared with baseline .
METHODS	Plasma omeprazole concentrations were measured on the first day of treatment after administration of GastroGard ( n = 5 ) or Gastrozol ( n = 5 ) .
RESULTS	Compared with baseline ( squamous score ( A ) 1.65 0.11 , ( B ) 1.98 0.11 ) , ulcer scores at 2 weeks ( ( A ) 0.89 0.11 , ( B ) 1.01 0.11 ) and 4 weeks ( ( A ) 1.10 0.12 , ( B ) 0.80 0.12 ) had significantly decreased in both groups ( P < .001 ) , independent of treatment ( P = .7 ) .
RESULTS	Plasma omeprazole concentrations were significantly higher after GastroGard compared with Gastrozol administration ( AUCGG = 2856 ( 1405-4576 ) ng/mL h , AUCGZ = 604 ( 430-1609 ) ng/mL h ; P = .03 ) .
RESULTS	The bioavailability for Gastrozol was 1.26 ( 95 % CI 0.56-2 .81 ) times higher than for GastroGard .
CONCLUSIONS	Both Gastrozol and GastroGard , combined with appropriate environmental changes , promote healing of gastric ulcers in horses .
CONCLUSIONS	However , despite enteric coating of Gastrozol , plasma omeprazole concentrations after single labeled doses were significantly higher with GastroGard .

###25409110
OBJECTIVE	There is a need for the accurate assessment of circadian phase outside of the clinic/laboratory , particularly with the gold standard dim light melatonin onset ( DLMO ) .
OBJECTIVE	We tested a novel kit designed to assist in saliva sampling at home for later determination of the DLMO .
OBJECTIVE	The home kit includes objective measures of compliance to the requirements for dim light and half-hourly saliva sampling .
METHODS	Participants were randomized to one of two 10-day protocols .
METHODS	Each protocol consisted of two back-to-back home and laboratory phase assessments in counterbalanced order , separated by a 5-day break .
METHODS	Laboratory or participants ' homes .
METHODS	Thirty-five healthy adults , age 21-62 y.
METHODS	N/A .
RESULTS	Most participants received at least one 30-sec epoch of light > 50 lux during the home phase assessments ( average light intensity 4.5 lux ) , but on average for < 9 min of the required 8.5 h. Most participants collected every saliva sample within 5 min of the scheduled time .
RESULTS	Ninety-two percent of home DLMOs were not affected by light > 50 lux or sampling errors .
RESULTS	There was no significant difference between the home and laboratory DLMOs ( P > 0.05 ) ; on average the home DLMOs occurred 9.6 min before the laboratory DLMOs .
RESULTS	The home DLMOs were highly correlated with the laboratory DLMOs ( r = 0.91 , P < 0.001 ) .
CONCLUSIONS	Participants were reasonably compliant to the home phase assessment procedures .
CONCLUSIONS	The good agreement between the home and laboratory dim light melatonin onsets ( DLMOs ) demonstrates that including objective measures of light exposure and sample timing during home saliva sampling can lead to accurate home DLMOs .
BACKGROUND	Circadian Phase Assessments at Home , http://clinicaltrials.gov/show/NCT01487252 , NCT01487252 .

###24590053
BACKGROUND	Both short wavelength ( blue ) light and caffeine have been studied for their mood enhancing effects on humans .
BACKGROUND	The ability of blue light to increase alertness , mood and cognitive function via non-image forming neuropathways has been suggested as a non-pharmacological countermeasure for depression across a range of occupational settings .
OBJECTIVE	This experimental study compared blue light and caffeine and aimed to test the effects of blue light/placebo ( BLU ) , white light/240-mg caffeine ( CAF ) , blue light/240-mg caffeine ( BCAF ) and white light/placebo ( PLA ) , on mood .
METHODS	A randomised , controlled , crossover design study was used , in a convenience population of 20 healthy volunteers .
METHODS	The participants rated their mood on the Swedish Core Affect Scales ( SCAS ) prior to and after each experimental condition to assess the dimensions of valence and activation .
RESULTS	There was a significant main effect of light ( p = 0.009 ) , and the combination of blue light and caffeine had clear positive effects on core effects ( ES , ranging from 0.41 to 1.20 ) and global mood ( ES , 0.610.53 ) .
CONCLUSIONS	The benefits of the combination of blue light and caffeine should be further investigated across a range of applications due to the observed effects on the dimensions of arousal , valence and pleasant activation .

###24342715
OBJECTIVE	To evaluate the efficacy of the five ear acupuncture points ( Shen-men , Spleen , Stomach , Hunger , Endocrine ) , generally used in Korean clinics for treating obesity , and compare them with the Hunger acupuncture point .
METHODS	A randomised controlled clinical trial was conducted in 91 Koreans ( 16 male and 75 female , body mass index ( BMI ) 23 ) , who had not received any other weight control treatment within the past 6 months .
METHODS	Subjects were divided randomly into treatment I , treatment II or sham control groups and received unilateral auricular acupuncture with indwelling needles replaced weekly for 8 weeks .
METHODS	Treatment I group received acupuncture at the five ear acupuncture points , treatment II group at the Hunger acupuncture point only and the sham control group received acupuncture at the five ear acupuncture points used in treatment I , but the needles were removed immediately after insertion .
METHODS	BMI , waist circumference , weight , body fat mass ( BFM ) , percentage body fat and blood pressure were measured at baseline and at 4 and 8 weeks after treatment .
RESULTS	For the 58 participants who provided data at 8 weeks , significant differences in BMI , weight and BFM were found between the treatment and control groups .
RESULTS	Treatment groups I and II showed 6.1 % and 5.7 % reduction in BMI , respectively ( p < 0.004 ) .
RESULTS	There were no significant differences between the two treatment groups .
CONCLUSIONS	This finding suggests that the five ear acupuncture points , generally used in Korean clinics , and the Hunger point alone treatment are both effective for treating overweight people .

###24786217
BACKGROUND	There are limited data regarding factors associated with spontaneous left ventricular reverse remodeling ( S-LVRR ) among mildly symptomatic heart failure ( HF ) patients and its prognostic implications on clinical outcomes .
RESULTS	Best subsets logistic regression analysis was used to identify factors associated with S-LVRR ( defined as 15 % reduction in left ventricular end-systolic volume at 1-year of follow-up ) among 612 patients treated with internal cardioverter defibrillator-only therapy in Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy ( MADIT-CRT ) and to create a score for the prediction of S-LVRR .
RESULTS	Cox proportional hazards regression modeling was used to assess the clinical outcome of all internal cardioverter defibrillator-only patients ( n = 714 ) with a high S-LVRR score .
RESULTS	S-LVRR occurred in 25 % of internal cardioverter defibrillator-only patients .
RESULTS	Predictors of S-LVRR included systolic blood pressure140 mm Hg , serum creatinine < 1.0 mg/dL , QRS 130 to 160 ms , and nonischemic cardiomyopathy .
RESULTS	Multivariate analysis showed that each 1-point increment in S-LVRR score ( range , 0-7 ) was associated with an 11 % ( P = 0.019 ) reduction in the risk of HF or death .
RESULTS	Treatment with cardiac resynchronization therapy was associated with a significant reduction in the risk of HF or death only among internal cardioverter defibrillator-treated patients with a low ( Q1-3 ) S-LVRR score ( hazard ratio = 0.55 ; P < 0.001 ) , but not among those with a higher ( Q4 ) score ( hazard ratio = 1.06 ; P = 0.72 ) .
CONCLUSIONS	Our data suggest that approximately one quarter of mild HF patients eligible for biventricular pacing experience S-LVRR .
CONCLUSIONS	Combined assessment of clinical factors associated with S-LVRR can be used to identify mild HF patients with a low risk for clinical events without cardiac resynchronization therapy intervention .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00180271 .

###24906705
OBJECTIVE	Early injection of atropine during dobutamine stress echocardiography ( DSE ) has been demonstrated in retrospective analyses to reduce the duration and dose of dobutamine infusion , while preserving a similar diagnostic accuracy with a lower incidence of adverse effects .
OBJECTIVE	This study explores the safety of using atropine as a start drug before dobutamine infusion ( ADSE protocol ) in comparison with the conventional protocol ( DASE protocol ) in older patients undergoing DSE for ischemia evaluation .
METHODS	One hundred consecutive older patients were prospectively enrolled .
METHODS	When eligible , they were randomly assigned to undergo either the DASE protocol ( group A , 50 patients ) or the ADSE protocol ( group B , 50 patients ) when atropine ( 1.0 mg ) was first administered 3 min before dobutamine infusion followed by 0.5 mg increments ( maximum 1.0 mg ) thereafter .
METHODS	Patients were monitored for adverse drug effects .
METHODS	Test duration was calculated .
RESULTS	The mean age of the whole study cohort was 67.84.3 years and 58 ( 58 % ) were men .
RESULTS	Patients in group A had longer test duration ( 21.81.3 versus 13.70.77 min , p < 0.001 ) and higher mean dobutamine infusion rate ( 398.2 versus 28.29.5 g/kg/min , p < 0.001 ) .
RESULTS	The two groups received a similar total dose of atropine .
RESULTS	Group A patients showed significantly higher incidence of extrasystoles , nonsustained ventricular tachycardia and severe hypotension ( p < 0.05 ) .
CONCLUSIONS	In older patients undergoing DSE , using atropine as a start drug , that is , adopting the ADSE protocol , is associated with shorter test duration , lower mean dobutamine infusion rate and consequently fewer adverse effects .

###25500372
OBJECTIVE	Headaches are a common medical problem , yet few studies , particularly trials , have evaluated therapies that might prevent or control headaches .
OBJECTIVE	We , thus , investigated the effects on the occurrence of headaches of three levels of dietary sodium intake and two diet patterns ( the Dietary Approaches to Stop Hypertension ( DASH ) diet ( rich in fruits , vegetables and low-fat dairy products with reduced saturated and total fat ) and a control diet ( typical of Western consumption patterns ) ) .
METHODS	Randomised multicentre clinical trial .
METHODS	Post hoc analyses of the DASH-Sodium trial in the USA .
METHODS	In a multicentre feeding study with three 30day periods , 390 participants were randomised to the DASH or control diet .
METHODS	On their assigned diet , participants ate food with high sodium during one period , intermediate sodium during another period and low sodium during another period , in random order .
METHODS	Occurrence and severity of headache were ascertained from self-administered questionnaires , completed at the end of each feeding period .
RESULTS	The occurrence of headaches was similar in DASH versus control , at high ( OR ( 95 % CI ) = 0.65 ( 0.37 to 1.12 ) ; p = 0.12 ) , intermediate ( 0.57 ( 0.29 to 1.12 ) ; p = 0.10 ) and low ( 0.64 ( 0.36 to 1.13 ) ; p = 0.12 ) sodium levels .
RESULTS	By contrast , there was a lower risk of headache on the low , compared with high , sodium level , both on the control ( 0.69 ( 0.49 to 0.99 ) ; p = 0.05 ) and DASH ( 0.69 ( 0.49 to 0.98 ) ; p = 0.04 ) diets .
CONCLUSIONS	A reduced sodium intake was associated with a significantly lower risk of headache , while dietary patterns had no effect on the risk of headaches in adults .
CONCLUSIONS	Reduced dietary sodium intake offers a novel approach to prevent headaches .
BACKGROUND	NCT00000608 .

###24326967
OBJECTIVE	The altered visual function induced by changes in corneal curvature following filtration surgery is distressing to patients .
OBJECTIVE	The aim of this study was to evaluate surgically induced astigmatism following trabeculectomy in comparison with deep sclerectomy .
METHODS	In a prospective interventional comparative study , patients with primary open-angle glaucoma were randomly allocated to either group A or B ; deep sclerectomy with mitomycin C 0.2 mg/mL and trabeculectomy with mitomycin C 0.2 mg/mL , respectively .
METHODS	Keratometry was performed using Topcon KR-7000P autokerato-refractometer preoperatively and at 6 months postoperatively .
METHODS	Vector analysis was used to analyze the surgically induced astigmatism .
RESULTS	Sixty eyes of 45 patients in group A , and 60 eyes of 42 patients in group B were enrolled for vector analysis .
RESULTS	The mean preoperative astigmatic vector power was -0.491.65 D and +0.472.18 D in groups A and B , respectively .
RESULTS	The mean postoperative astigmatic vector power was -1.141.55 D in group A and -0.351.8 D in group B.
RESULTS	The mean change in astigmatic vector powers was -0.671.63 D in group A and -0.822.0 D in group B.
RESULTS	When compared with preoperative data in either group , the differences were significant , P = 0.001 & 0.007 in groups A and B respectively , whereas the postoperative difference between either group was insignificant ( P = 0.723 ) .
RESULTS	A total of 40 % of corneas got flatter in group B compared with 25 % in group A , P = 0.057 .
CONCLUSIONS	Both trabeculectomy and deep sclerectomy induced considerable postoperative astigmatism .
CONCLUSIONS	A longer follow-up period is recommended to study the different patterns of astigmatism in either procedure .

###25654728
BACKGROUND	Based on promising efficacy in a single-arm study , a randomized phase II trial was designed to compare the efficacy and safety of adding rh-endostatin ( Endostar ) to first-line standard etoposide and carboplatin ( EC ) chemotherapy for treatment of extensive-stage small-cell lung cancer .
METHODS	One hundred forty Chinese patients with pathologically confirmed , extensive-stage small-cell lung cancer were randomly assigned to EC alone or rh-endostatin + EC for 4-6 cycles , followed by single-agent rh-endostatin until progression or unacceptable toxicity .
METHODS	The primary endpoint was progression-free survival ( PFS ) .
METHODS	The secondary endpoints included overall survival , Objective response rate ( ORR ) , and quality of life .
RESULTS	Median PFS was 6.4 months with rh-endostatin + EC ( n = 69 ) and 5.9 months with EC ( n = 69 ) ( hazard ratio 0.8 [ 95 % confidence interval 0.6-1 .1 ] ) .
RESULTS	PFS was significantly higher with rh-endostatin + EC than with EC ( hazard ratio 0.4 [ 0.2-0 .9 ; p = 0.020 ] ) in female .
RESULTS	Median overall survival was similar in both groups ( 12.1 versus 12.4 months , respectively [ p = 0.82 ] ) .
RESULTS	ORR was higher in the rh-endostatin + EC group ( 75.4 % ) than in the EC group ( 66.7 % ) ( p = 0.348 ) .
RESULTS	The efficacy of rh-endostatin + EC relative to that of EC was reflected by greater improvements in patient-assessed quality of life scores after 4 and 6 weeks of treatment .
RESULTS	There was no difference between each regimen in the incidence of nonhematological or Grade III-IV hematological toxicities .
CONCLUSIONS	Addition of rh-endostatin to EC for the treatment of extensive-stage small-cell lung cancer had an acceptable toxicity profile , but did not improve overall survival , PFS , and ORR .

###24600321
BACKGROUND	Optical trapping is a laser-based method for probing the physiological and mechanical properties of cells in a noninvasive manner .
BACKGROUND	As sperm motility is an important criterion for assessing the male fertility potential , this technique is used to study sperm cell motility behavior and rotational dynamics .
METHODS	An integrated optical system with near-infrared laser beam has been used to analyze rotational dynamics of live sperm cells from oligozoospermic and asthenozoospermic cases and compared with controls .
RESULTS	The linear , translational motion of the sperm is converted into rotational motion on being optically trapped , without causing any adverse effect on spermatozoa .
RESULTS	The rotational speed of sperm cells from infertile men is observed to be significantly less as compared to controls .
CONCLUSIONS	Distinguishing normal and abnormal sperm cells on the basis of beat frequency above 5.6 Hz may be an important step in modern reproductive biology to sort and select good quality spermatozoa .
CONCLUSIONS	The application of laser-assisted technique in biology has the potential to be a valuable tool for assessment of sperm fertilization capacity for improving assisted reproductive technology .

###24810863
BACKGROUND	Recent studies have demonstrated safety , feasibility , and decreased hospital length of stay for patients with weakness acquired in the intensive care unit ( ICU ) who receive early physical rehabilitation .
BACKGROUND	The scored Physical Function in Intensive Care Test ( PFIT-s ) was specifically designed for this population and demonstrated excellent psychometrics in an Australian ICU population .
OBJECTIVE	The purpose of this study was to determine the responsiveness and predictive capabilities of the PFIT-s in patients in the United States admitted to the ICU who required mechanical ventilation ( MV ) for 4 days or longer .
METHODS	This nested study within a randomized trial administered the PFIT-s , Medical Research Council ( MRC ) sum score , and grip strength test at ICU recruitment and then weekly until hospital discharge , including at ICU discharge .
METHODS	Spearman rho was used to determine validity .
METHODS	The effect size index was used to calculate measurement responsiveness for the PFIT-s .
METHODS	The receiver operating characteristic curve was used in predicting participants ' ability to perform functional components of the PFIT-s .
RESULTS	From August 2009 to July 2012 , 51 patients were recruited from 4 ICUs in the Denver , Colorado , metro area .
RESULTS	At ICU discharge , PFIT-s scores were highly correlated to MRC sum scores ( rho = .923 ) and grip strength ( rho = .763 ) ( P < .0005 ) .
RESULTS	Using baseline test with ICU discharge ( 26 pairs ) , test responsiveness was large ( 1.14 ) .
RESULTS	At ICU discharge , an MRC sum score cut-point of 41.5 predicted participants ' ability to perform the standing components of the PFIT-s .
CONCLUSIONS	The small sample size was a limitation .
CONCLUSIONS	However , the findings are consistent with those in a larger sample from Australia .
CONCLUSIONS	The PFIT-s is a feasible and valid measure of function for individuals who require MV for 4 days or longer and who are alert , able to follow commands , and have sufficient strength to participate .

###24909468
BACKGROUND	Post-operative nausea and vomiting ( PONV ) ; early or late , has detrimental effects on surgical patients such as surgical wound disruption , esophageal tear and delayed discharge from the post anesthetic care unit .
BACKGROUND	This study evaluated the effects of dexamethasone-metoclopramide ( DM ) in the prevention of early and late PONV in women undergoing myomectomy under subarachnoid block .
METHODS	Following approval from the Research and Ethics Committee of the Hospital , informed consent was obtained from each prospective patient .
METHODS	Patients were randomly allocated to either the DM group , metoclopramide only ( MO ) group or dexamethasones only ( DO ) group using the computer-generated random numbers in sealed envelopes .
METHODS	Immediately after the induction of spinal anesthesia , the DM group received intravenous ( i.v. ) dexamethasone 8 mg and metoclopramide 10 mg , the MO group received metoclopramide 10 mg i.v and the DO group received dexamethasone 8 mg i.v.
METHODS	The incidence of early and late PONV formed the primary outcome .
RESULTS	A total of 90 patients , with aged range between 21-64 years were studied .
RESULTS	Dexamethasone alone group had the highest incidence of 40 % for early but no for late PONV ( P = 0.003 ) Metoclopramide alone group had an incidence of 29.97 % for early PONV and 26.6 % for late PONV .
RESULTS	There was reduced incidence of both early and late PONV in the DM group , but of lesser magnitude than DO or MO respectively .
CONCLUSIONS	Dexamethasone protects against the incidence of late PONV with a minimal effect on early PONV .
CONCLUSIONS	The combination of dexamethasone and metoclopramide had comparable effect on both and of better magnitude than metoclopramide alone .

###25462653
BACKGROUND	The effects of family therapy for adolescent substance use on parent substance use have not been explored .
OBJECTIVE	To determine the effects of Brief Strategic Family Therapy ( BSFT ) on parent substance use , and the relationship between parent substance use and adolescent substance use .
METHODS	480 adolescents and parents were randomized to BSFT or Treatment as Usual ( TAU ) across eight outpatient treatment programs .
METHODS	Parent substance use was assessed at baseline and at 12months post-randomization .
METHODS	Adolescent substance use was assessed at baseline and monthly for 12months post-randomization .
METHODS	Family functioning was assessed at baseline , 4 , 8 , and 12months post-randomization .
RESULTS	Parents in BSFT significantly decreased their alcohol use as measured by the ASI composite score from baseline to 12months ( ( 2 ) ( 1 ) = 4.46 , p = .04 ) .
RESULTS	Change in family functioning mediated the relationship between Treatment Condition and change in parent alcohol use .
RESULTS	Children of parents who reported drug use at baseline had three times as many days of reported substance use at baseline compared with children of parents who did not use or only used alcohol ( ( 2 ) ( 2 ) = 7.58 , p = .02 ) .
RESULTS	Adolescents in BSFT had a significantly lower trajectory of substance use than those in TAU ( = -7.82 , p < .001 ) if their parents used drugs at baseline .
CONCLUSIONS	BSFT is effective in reducing alcohol use in parents , and in reducing adolescents ' substance use in families where parents were using drugs at baseline .
CONCLUSIONS	BSFT may also decrease alcohol use among parents by improving family functioning .

###24574235
OBJECTIVE	To identify the clinical and laboratory predictors of clinical improvement in a cohort of myositis patients treated with rituximab .
METHODS	We analyzed data for 195 patients with myositis ( 75 with adult polymyositis [ PM ] , 72 with adult dermatomyositis [ DM ] , and 48 with juvenile DM ) in the Rituximab in Myositis trial .
METHODS	Clinical improvement was defined as 20 % improvement in at least 3 of the following 6 core set measures of disease activity : physician 's and patient 's / parent 's global assessment of disease activity , manual muscle testing , physical function , muscle enzymes , and extramuscular disease activity .
METHODS	We analyzed the association of the following baseline variables with improvement : myositis clinical subgroup , demographics , myositis damage , clinical and laboratory parameters , core set measures , rituximab treatment , and myositis autoantibodies ( antisynthetase , anti-Mi-2 , anti-signal recognition particle , anti-transcription intermediary factor 1 [ TIF-1 ] , anti-MJ , other autoantibodies , and no autoantibodies ) .
METHODS	All measures were univariately assessed for association with improvement using time-to-event analyses .
METHODS	A multivariable time-dependent proportional hazards model was used to evaluate the association of individual predictive factors with improvement .
RESULTS	In the final multivariable model , the presence of an antisynthetase , primarily anti-Jo-1 ( hazard ratio [ HR ] 3.08 , P < 0.01 ) , anti-Mi-2 ( HR 2.5 , P < 0.01 ) , or other autoantibody ( HR 1.4 , P = 0.14 ) predicted a shorter time to improvement compared to the absence of autoantibodies .
RESULTS	A lower physician 's global assessment of damage ( HR 2.32 , P = 0.02 ) and juvenile DM ( versus adult myositis ) ( HR 2.45 , P = 0.01 ) also predicted improvement .
RESULTS	Unlike autoantibody status , the predictive effect of physician 's global assessment of damage and juvenile DM diminished by week 20 .
RESULTS	Rituximab treatment did not affect these associations .
CONCLUSIONS	Our findings indicate that the presence of antisynthetase and anti-Mi-2 autoantibodies , juvenile DM subset , and lower disease damage strongly predict clinical improvement in patients with refractory myositis .

###24825642
OBJECTIVE	In phase 2 studies , evolocumab , a fully human monoclonal antibody to PCSK9 , reduced LDL-C levels in patients receiving statin therapy .
OBJECTIVE	To evaluate the efficacy and tolerability of evolocumab when used in combination with a moderate - vs high-intensity statin .
METHODS	Phase 3 , 12-week , randomized , double-blind , placebo - and ezetimibe-controlled study conducted between January and December of 2013 in patients with primary hypercholesterolemia and mixed dyslipidemia at 198 sites in 17 countries .
METHODS	Patients ( n = 2067 ) were randomized to 1 of 24 treatment groups in 2 steps .
METHODS	Patients were initially randomized to a daily , moderate-intensity ( atorvastatin [ 10 mg ] , simvastatin [ 40 mg ] , or rosuvastatin [ 5 mg ] ) or high-intensity ( atorvastatin [ 80 mg ] , rosuvastatin [ 40 mg ] ) statin .
METHODS	After a 4-week lipid-stabilization period , patients ( n = 1899 ) were randomized to compare evolocumab ( 140 mg every 2 weeks or 420 mg monthly ) with placebo ( every 2 weeks or monthly ) or ezetimibe ( 10 mg or placebo daily ; atorvastatin patients only ) when added to statin therapies .
METHODS	Percent change from baseline in low-density lipoprotein cholesterol ( LDL-C ) level at the mean of weeks 10 and 12 and at week 12 .
RESULTS	Evolocumab reduced LDL-C levels by 66 % ( 95 % CI , 58 % to 73 % ) to 75 % ( 95 % CI , 65 % to 84 % ) ( every 2 weeks ) and by 63 % ( 95 % CI , 54 % to 71 % ) to 75 % ( 95 % CI , 67 % to 83 % ) ( monthly ) vs placebo at the mean of weeks 10 and 12 in the moderate - and high-intensity statin-treated groups ; the LDL-C reductions at week 12 were comparable .
RESULTS	For moderate-intensity statin groups , evolocumab every 2 weeks reduced LDL-C from a baseline mean of 115 to 124 mg/dL to an on-treatment mean of 39 to 49 mg/dL ; monthly evolocumab reduced LDL-C from a baseline mean of 123 to 126 mg/dL to an on-treatment mean of 43 to 48 mg/dL .
RESULTS	For high-intensity statin groups , evolocumab every 2 weeks reduced LDL-C from a baseline mean of 89 to 94 mg/dL to an on-treatment mean of 35 to 38 mg/dL ; monthly evolocumab reduced LDL-C from a baseline mean of 89 to 94 mg/dL to an on-treatment mean of 33 to 35 mg/dL .
RESULTS	Adverse events were reported in 36 % , 40 % , and 39 % of evolocumab - , ezetimibe - , and placebo-treated patients , respectively .
RESULTS	The most common adverse events in evolocumab-treated patients were back pain , arthralgia , headache , muscle spasms , and pain in extremity ( all < 2 % ) .
CONCLUSIONS	In this 12-week trial conducted among patients with primary hypercholesterolemia and mixed dyslipidemia , evolocumab added to moderate - or high-intensity statin therapy resulted in additional LDL-C lowering .
CONCLUSIONS	Further studies are needed to evaluate the longer-term clinical outcomes and safety of this approach for LDL-C lowering .
BACKGROUND	clinicaltrials.gov Identifier : NCT01763866 .

###25769911
BACKGROUND	IL-23 is associated with plaque psoriasis susceptibility and pathogenesis .
BACKGROUND	BI 655066 is a fully human IgG1 mAb specific for the IL-23 p19 subunit .
OBJECTIVE	This first-in-human proof-of-concept study evaluated the clinical and biological effects of BI 655066 in patients with moderate-to-severe plaque psoriasis .
METHODS	We performed a single-rising-dose , multicenter , randomized , double-blind , placebo-controlled , within-dose cohort phase I trial .
METHODS	Patients received 0.01 , 0.05 , 0.25 , 1 , 3 , or 5 mg/kg BI 655066 intravenously , 0.25 or 1 mg/kg BI 655066 subcutaneously , or matched placebo .
METHODS	The primary objective was safety evaluation .
RESULTS	Thirty-nine patients received single-dose BI 655066 intravenously ( n = 18 ) or subcutaneously ( n = 13 ) or placebo ( n = 8 ) .
RESULTS	Adverse events were reported with similar frequency in the BI 655066 and placebo groups .
RESULTS	Four serious adverse events ( not considered treatment related ) were reported among BI 655066-treated patients .
RESULTS	BI 655066 was associated with clinical improvement from week 2 and maintained for up to 66 weeks after treatment .
RESULTS	At week 12 , 75 % , 90 % , and 100 % decreases in the Psoriasis Area and Severity Index were achieved by 87 % , 58 % , and 16 % of BI 655066-treated patients ( any dose ) , respectively , versus none receiving placebo .
RESULTS	BI 655066 treatment resulted in reduced expression of lesional skin genes associated with IL-23 / IL-17 signaling pathways and normalization of psoriatic lesion gene expression profiles to a profile approaching that of nonlesional skin .
RESULTS	Significant correlation between treatment-associated molecular changes and psoriasis area and severity index improvement was observed ( r = 0.73 , P = 2 10 ( -6 ) ) .
CONCLUSIONS	BI 655066 was well tolerated and associated with rapid , substantial , and durable clinical improvement in patients with moderate-to-severe psoriasis , supporting a central role for IL-23 in psoriasis pathogenesis .

###25221387
BACKGROUND	Accumulated evidence implicates sympathetic activation as inducing oxidative stress and systemic inflammation , which in turn lead to hypertension , endothelial dysfunction , and atherosclerosis in obstructive sleep apnea ( OSA ) .
BACKGROUND	Statins through their pleiotropic properties may modify inflammation , lipid profile , and cardiovascular outcomes in OSA .
METHODS	This multicenter , randomized , double-blind study compared the effects of atorvastatin 40mg/day versus placebo over 12 weeks on endothelial function ( the primary endpoint ) measured by peripheral arterial tone ( PAT ) .
METHODS	Secondary endpoints included office blood pressure ( BP ) , early carotid atherosclerosis , arterial stiffness measured by pulse wave velocity ( PWV ) , and metabolic parameters .
RESULTS	51 severe OSA patients were randomized .
RESULTS	Key demographics for the study population were age 54 11 years , 21.6 % female , and BMI 28.5 4.5 kg/m ( 2 ) .
RESULTS	In intention to treat analysis , mean PAT difference between atorvastatin and placebo groups was 0.008 ( -0.29 ; 0.28 ) , P = 0.979 .
RESULTS	Total and LDL cholesterol significantly improved with atorvastatin .
RESULTS	Systolic BP significantly decreased with atorvastatin ( mean difference : -6.34 mmHg ( -12.68 ; -0.01 ) , P = 0.050 ) whereas carotid atherosclerosis and PWV were unchanged compared to the placebo group .
CONCLUSIONS	In OSA patients , 3 months of atorvastatin neither improved endothelial function nor reduced early signs of atherosclerosis although it lowered blood pressure and improved lipid profile .
CONCLUSIONS	This trial is registered with NCT00669695 .

###24667509
OBJECTIVE	To determine whether a structured mentoring curriculum improves research mentoring skills .
METHODS	The authors conducted a randomized controlled trial ( RCT ) at 16 academic health centers ( June 2010 to July 2011 ) .
METHODS	Faculty mentors of trainees who were conducting clinical/translational research 50 % of the time were eligible .
METHODS	The intervention was an eight-hour , case-based curriculum focused on six mentoring competencies .
METHODS	The primary outcome was the change in mentors ' self-reported pretest to posttest composite scores on the Mentoring Competency Assessment ( MCA ) .
METHODS	Secondary outcomes included changes in the following : mentors ' awareness as measured by their self-reported retrospective change in MCA scores , mentees ' ratings of their mentors ' competency as measured by MCA scores , and mentoring behaviors as reported by mentors and their mentees .
RESULTS	A total of 283 mentor-mentee pairs were enrolled : 144 mentors were randomized to the intervention ; 139 to the control condition .
RESULTS	Self-reported pre - / posttest change in MCA composite scores was higher for mentors in the intervention group compared with controls ( P < .001 ) .
RESULTS	Retrospective changes in MCA composite scores between the two groups were even greater , and extended to all six subscale scores ( P < .001 ) .
RESULTS	More intervention-group mentors reported changes in their mentoring practices than control mentors ( P < .001 ) .
RESULTS	Mentees working with intervention-group mentors reported larger changes in retrospective MCA pre - / posttest scores ( P = .003 ) and more changes in their mentors ' behavior ( P = .002 ) than those paired with control mentors .
CONCLUSIONS	This RCT demonstrates that a competency-based research mentor training program can improve mentors ' skills .

###26393848
OBJECTIVE	Cardiovascular disease prevention , including lifestyle modification , is important but underutilized .
OBJECTIVE	Mobile health strategies could address this gap but lack evidence of therapeutic benefit .
OBJECTIVE	To examine the effect of a lifestyle-focused semipersonalized support program delivered by mobile phone text message on cardiovascular risk factors .
METHODS	The Tobacco , Exercise and Diet Messages ( TEXT ME ) trial was a parallel-group , single-blind , randomized clinical trial that recruited 710 patients ( mean age , 58 [ SD , 9.2 ] years ; 82 % men ; 53 % current smokers ) with proven coronary heart disease ( prior myocardial infarction or proven angiographically ) between September 2011 and November 2013 from a large tertiary hospital in Sydney , Australia .
METHODS	Patients in the intervention group ( n = 352 ) received 4 text messages per week for 6 months in addition to usual care .
METHODS	Text messages provided advice , motivational reminders , and support to change lifestyle behaviors .
METHODS	Patients in the control group ( n = 358 ) received usual care .
METHODS	Messages for each participant were selected from a bank of messages according to baseline characteristics ( eg , smoking ) and delivered via an automated computerized message management system .
METHODS	The program was not interactive .
METHODS	The primary end point was low-density lipoprotein cholesterol ( LDL-C ) level at 6 months .
METHODS	Secondary end points included systolic blood pressure , body mass index ( BMI ) , physical activity , and smoking status .
RESULTS	At 6 months , levels of LDL-C were significantly lower in intervention participants , with concurrent reductions in systolic blood pressure and BMI , significant increases in physical activity , and a significant reduction in smoking .
RESULTS	The majority reported the text messages to be useful ( 91 % ) , easy to understand ( 97 % ) , and appropriate in frequency ( 86 % ) .
RESULTS	[ table : see text ] .
CONCLUSIONS	Among patients with coronary heart disease , the use of a lifestyle-focused text messaging service compared with usual care resulted in a modest improvement in LDL-C level and greater improvement in other cardiovascular disease risk factors .
CONCLUSIONS	The duration of these effects and hence whether they result in improved clinical outcomes remain to be determined .
BACKGROUND	anzctr.org.au Identifier : ACTRN12611000161921 .

###24393593
BACKGROUND	Hydroxyethyl starch ( HES ) is a colloid that has been widely used for fluid resuscitation for decades .
BACKGROUND	The newest generation of HES , tetrastarch , was believed to provide an efficient volume expansion without causing the side effects observed with former HES solutions .
BACKGROUND	However , this belief was based on physiological models and small studies rather than on firm clinical evidence .
BACKGROUND	Our aim was to assess the safety and efficacy of tetrastarch in a randomised clinical trial and in a systematic review .
METHODS	We first conducted a blinded , clinical trial , in which we randomly assigned patients with severe sepsis in the intensive care unit to fluid resuscitation with either 6 % HES 130/0 .42 ( Tetraspan ) or Ringer 's acetate .
METHODS	The primary outcome measure was death or dialysis-dependency at 90 days after randomisation .
METHODS	Secondary outcomes described kidney function and serious adverse reactions .
METHODS	Secondly , we systematically identified all randomised clinical trials comparing tetrastarch with either crystalloid or albumin in patients with sepsis and pooled their results in meta-analyses and trial sequential analyses .
RESULTS	Of the 804 patients who underwent randomisation , 798 were included in the modified-intention-to-treat population .
RESULTS	At 90 days after randomisation , 201 of 398 patients ( 51 % ) assigned to HES 130/0 .42 had died , as compared with 172 of 400 patients ( 43 % ) assigned to Ringer 's acetate ( relative risk 1.17 , p = 0.03 ) ; 1 patient in each group was dialysis-dependent at 90 days .
RESULTS	In the 90 day observation period , 87 patients ( 22 % ) assigned to HES received renal replacement therapy vs. 65 patients ( 16 % ) assigned to Ringer 's acetate ( relative risk 1.35 , p = 0.04 ) , and 38 patients ( 10 % ) vs. 25 patients ( 6 % ) had severe bleeding ( relative risk 1.52 , p = 0.09 ) .
RESULTS	Post-hoc sensitivity analysis showed a strongly significant increased risk of any bleeding with HES vs. Ringer 's acetate ( relative risk 1.56 , p = 0.003 ) .
RESULTS	In the systematic review , we identified nine trials that randomised 3,456 patients with sepsis .
RESULTS	In meta-analyses , tetrastarch vs. crystalloid or albumin lead to increased use of renal replacement therapy ( relative risk 1.36 , p = 0.009 ) and red blood cells ( relative risk 1.29 , p = 0.0002 ) and to more serious adverse events ( relative risk 1.30 , p = 0.03 ) .
RESULTS	Trials with low risk of bias suggested 11 % increased risk of death .
RESULTS	After adjusting the results with trial sequential analysis signals for harm persisted .
CONCLUSIONS	Our randomised clinical trial is one of several high-quality trials in critically ill patients with and without sepsis that now provide evidence that the use of tetrastarch impairs kidney function and haemostasis and may even increase mortality .
CONCLUSIONS	Whether the results can be extrapolated to other types of patients is unclear , but so far no group of patients with an overall benefit of HES beyond surrogate markers has been identified .
CONCLUSIONS	In line with this , the European Medicines Agency 's Pharmacovigilance Risk Assessment Committee now recommends that the marketing authorisations of all HES solutions are suspended in the European Union .

###24576532
OBJECTIVE	The objective of this study was to evaluate the long-term efficacy , safety , and tolerability of paliperidone extended-release ( pali ER ) , in Chinese patients with schizophrenia .
METHODS	In this parallel-group , relapse prevention , phase-3 study ( screening [ 14-day ] , pali ER open-label run-in [ 8-week ] and stabilization [ 6-week ] phases , and double-blind ( DB ) treatment [ variable duration ] , and open-label extension phases [ 24-week ] ) , 136/201 patients with schizophrenia were randomized ( 1:1 ) to pali ER ( 3-12 mg ) or placebo during the DB phase .
RESULTS	Final analysis showed that , out of 135 patients in ITT ( DB ) population , 71 ( 52.6 % ) had a relapse event , 45 ( 33.3 % ) were ongoing at the time the study was stopped , and 19 ( 14.1 % ) discontinued from the DB phase .
RESULTS	Time to relapse ( primary endpoint ) favored pali ER ( hazard ratio = 5.23 [ 95 % CI : 2.96 , 9.25 ] , p < 0.0001 ) .
RESULTS	Rate of relapses ( 55/71 [ 77.5 % ] placebo ; 16/64 [ 25 % ] pali ER ) and secondary endpoints ( change from baseline in Positive And Negative Syndrome Scale [ PANSS ] and Clinical Global Impression - Severity Scores ) were significantly lower ( p < 0.001 ) in pali ER group vs placebo , in favor of pali ER .
RESULTS	More psychiatric-related treatment-emergent adverse events ( TEAEs ) occurred in placebo - ( 21.1 % ) than pali ER group ( 10.9 % ) .
RESULTS	Most common ( > 3 % ) TEAEs in placebo group were insomnia and schizophrenia ( 8.5 % each ) , while in pali ER group were aggression and akathisia ( 4.7 % each ) , and schizophrenia , tremor , nausea , amenorrhea , and salivary hypersecretion ( 3.1 % each ) .
RESULTS	All serious TEAEs were psychiatric-related ( schizophrenia , aggression , completed suicide , auditory hallucination , suicide attempt ) and more frequent in placebo - ( 11.3 % ) versus pali ER group ( 3.1 % ) .
RESULTS	Death and tardive dyskinesia-related discontinuation ( n = 1 each ) occurred in placebo group .
RESULTS	Body weight increase from run-in baseline was greater in pali ER group ( mean increase : 3.90 kg ) versus placebo ( mean increase : 2.05 kg ) .
CONCLUSIONS	This study confirms the findings from earlier pali ER global relapse-prevention studies and demonstrates that pali ER treatment ( 3-12 mg ) is efficacious over the long-term and significantly delays relapse in Chinese patients with schizophrenia .
CONCLUSIONS	No new safety signals were detected in this population .

###24656944
BACKGROUND	Chronic rhinosinusitis is common in cystic fibrosis ( CF ) , as CFTR defects equally affect the airway and sinonasal mucosa .
BACKGROUND	However , therapeutic strategies for CF-associated chronic rhinosinusitis lag behind current approaches for pulmonary disease .
OBJECTIVE	To assess the tolerability and efficacy of a nasal spray formulation containing 0.2 % sodium hyaluronate and 3 % tobramycin compared to a control formulation containing 0.2 % sodium hyaluronate alone in the treatment of bacterial rhinosinusitis in patients with CF.
METHODS	In a double-blind controlled study , 27 patients with an established diagnosis of CF and a documented nasal infection with Pseudomonas aeruginosa and/or Staphylococcus aureus [ 22 males ( 81 % ) , median age of 15 years ( range 5-26 yrs ) ] , were randomized to receive the nasal spray formulation containing hyaluronate and tobramycin ( N = 14 ) or hyaluronate alone ( N = 13 ) for 14 days .
METHODS	Efficacy and local tolerability of the treatments were assessed by ear , nose and throat ( ENT ) examination and related symptoms .
RESULTS	The formulation containing hyaluronate and tobramycin was more effective than hyaluronate alone in improving the status of the nasal mucosa , in reducing the mucopurulent secretion at the level of the osteomeatal complex and in improving ENT symptoms ( hyposmia/anosmia and headache/facial pain ) .
RESULTS	The treatment was well tolerated without relevant side effects .
CONCLUSIONS	The present study suggests that the combination therapy with hyaluronate plus tobramycin was more effective than hyaluronate alone in the treatment of bacterial rhinosinusitis in CF.
BACKGROUND	EudraCT 2007-003628-39 .

###24888381
BACKGROUND	Early-onset dementia is common in Down syndrome adults , who have trisomy 21 .
BACKGROUND	The amyloid precursor protein gene is on chromosome 21 , and so is over-expressed in Down syndrome , leading to amyloid ( A ) over-production , a major upstream pathway leading to Alzheimer disease ( AD ) .
BACKGROUND	Statins ( microsomal 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors ) , have pleiotropic effects including potentially increasing brain amyloid clearance , making them plausible agents to reduce AD risk .
BACKGROUND	Animal models , human observational studies , and small scale trials support this rationale , however , there are no AD primary prevention trials in Down syndrome adults .
BACKGROUND	In this study we study aim to inform the design of a full-scale primary prevention trial .
METHODS	TOP-COG is a feasibility and pilot double-blind randomized controlled trial ( RCT ) , with a nested qualitative study , conducted in the general community .
METHODS	About 60 Down syndrome adults , aged 50 will be included .
METHODS	The intervention is oral simvastatin 40 mg at night for 12 months , versus placebo .
METHODS	The primary endpoint is recruitment and retention rates .
METHODS	Secondary endpoints are ( 1 ) tolerability and safety ; ( 2 ) detection of the most sensitive neurocognitive instruments ; ( 3 ) perceptions of Down syndrome adults and caregivers on whether to participate , and assessment experiences ; ( 4 ) distributions of cognitive decline , adaptive behavior , general health/quality of life , service use , caregiver strain , and sample size implications ; ( 5 ) whether A42/A40 is a cognitive decline biomarker .
METHODS	We will describe percentages recruited from each source , the number of contacts to achieve this , plus recruitment rate by general population size .
METHODS	We will calculate summary statistics with 90 % confidence limits where appropriate , for each study outcome as a whole , by treatment group and in relation to baseline age , cognitive function , cholesterol and other characteristics .
METHODS	Changes over time will be summarized graphically .
METHODS	The sample size for a definitive RCT will be estimated under alternative assumptions .
CONCLUSIONS	This study is important , as AD is a major problem for Down syndrome adults , for whom there are currently no effective preventions or treatments .
CONCLUSIONS	It will also delineate the most suitable assessment instruments for this population .
CONCLUSIONS	Recruitment of intellectually disabled adults is notoriously difficult , and we shall provide valuable information on this , informing future studies .
BACKGROUND	Current Controlled Trials ISRCTN Register ID : ISRCTN67338640 ( 17 November 2011 ) .

###24996507
BACKGROUND	While antipsychotics are effective in the maintenance treatment of schizophrenia they have safety and tolerability risks .
BACKGROUND	We investigated whether a combination of omega-3 polyunsaturated fatty acids ( -3 PUFAs ) and a metabolic antioxidant , alpha-lipoic acid ( - LA ) , is effective in preventing relapse after antipsychotic discontinuation in subjects who were successfully treated for 2-3 years after a first-episode of schizophrenia , schizo-affective or schizophreniform disorder .
METHODS	In this randomized , double-blind , placebo controlled study antipsychotic treatment was tapered and discontinued and participants received either -3 PUFAs ( eicosapentaenoic acid 2g/day and docosahexaenoic acid 1g/day ) + - LA 300 mg/day or placebo .
METHODS	Subjects were followed up for two years , or until relapse .
RESULTS	Recruitment was terminated prematurely due to the high relapse rates in both treatment groups as well as the severity of some of the relapse episodes .
RESULTS	Of the 33 participants , 19/21 ( 90 % ) randomized to -3 PUFAs + - LA relapsed and one ( 5 % ) completed two years without relapse ( p = 0.6 ) ; and 9/12 ( 75 % ) randomized to placebo relapsed and none completed two years without relapse .
RESULTS	Mean times to relapse were 39.8 25.4 and 38.3 26.6 weeks for the -3 PUFAs + - LA and placebo groups , respectively ( p = 0.9 ) .
RESULTS	There were no significant differences between the groups in relapse symptom severity .
CONCLUSIONS	We found no evidence that -3 PUFAs + - LA could be a suitable alternative to maintenance antipsychotic treatment in relapse prevention , in this small study .
CONCLUSIONS	Antipsychotic discontinuation after a single episode of schizophrenia carries a very high risk of relapse , and treatment guidelines endorsing this practice should be revised .

###24370959
OBJECTIVE	To compare loop excisions of cervical intraepithelial neoplasia grade 2 or worse ( CIN 2 + ) under video exoscopy , or colposcopic guidance , with respect to safety and effectiveness .
METHODS	Prospective multicentric randomized trial of 300 patients , undergoing loop excision for CIN 2 + either under video exoscopy ( group A ) or colposcope ( group B ) guidance .
METHODS	Intra - and post-operative complications , resection margins , and removed cervical volume in both groups were evaluated .
RESULTS	19.3 % of patients in video exoscopy group and 15.5 % in colposcopy group ( p = 0.67 ) had transformation zone ( TZ ) 3.45 / 151 ( 29.8 % ) of group A patients and 48/149 ( 32.2 % ) of group B patients underwent top-hat procedure , i.e. , one superficial excision followed by one deeper removal of the endocervical tissue ( p = 0.74 ) .
RESULTS	There was no difference in intra - and post-operative complications in the two groups .
RESULTS	Positive endocervical resection margins ( R0 ) were 9.9 % in video exoscopy group and 8.7 % in colposcopy group , respectively .
RESULTS	Unclear endocervical resection margins ( Rx ) were 2.0 % in both groups .
RESULTS	Mean total excised cervical volume was 1.20 cubic centimeter ( cc ) in group A , and 1.24 cc in group B , respectively .
RESULTS	Recurrent disease occurred in 2.3 % of patients at 6 months follow-up .
CONCLUSIONS	Magnification assisted loop excision of CIN 2 + is equally effective and safe under colposcopic and video exoscopy guidance .
CONCLUSIONS	The latter technique could potentially offer an alternative treatment of CIN 2 + lesions for doctors unfamiliar with colposcope .

###25070447
OBJECTIVE	To investigate the effect of microbial immune enteral nutrition composed of probiotics , deep sea fish oil , glutamine and nutrison on postoperative immune status , insulin resistance and infectious complication morbidity in patients with abdominal infection .
METHODS	From September 2010 to April 2013 in Shandong Liaocheng City Hospital , 96 patients with upper gastrointestinal perforation were prospectively randomized into the treatment group ( microbial immune enteral nutrition , n = 48 ) and the control group ( conventional enteral nutrition , n = 48 ) .
METHODS	Number of T cell subsets ( CD3 ( + ) , CD4 ( + ) , CD8 ( + ) , CD4 ( + ) / CD8 ( + ) ) and natural killer ( NK ) cell , procalcitonin ( PCT ) , fasting blood glucose ( FBG ) , fasting insulin ( FINS ) , insulin resistance index ( InHOMA-IR ) calculated by the homeostasis model assessment ( HOMA ) were detected before operation and on days 3 and 7 after operation and compared between the two groups .
METHODS	The incidence of postoperative infectious complication was collected and compared as well .
RESULTS	There were no significant differences in immune indexes and insulin resistance-associated indexes between the two groups before operation and on the day 3 after operation ( all P > 0.05 ) .
RESULTS	On postoperative day 7 , CD4 ( + ) , CD4 ( + ) / CD8 ( + ) and NK cells in treatment group were significantly higher than those in control group [ ( 39.14.3 ) % vs. ( 30.15.7 ) % , P = 0.043 ; 1.760.21 vs. 1.360.12 , P = 0.038 ; ( 19.34.8 ) % vs. ( 13.33.2 ) % , P = 0.032 ] , while FINS , lnHOMA-IR and PCT in treatment group were significantly lower than those in control group [ ( 7.31.7 ) mU/L vs. ( 10.22.1 ) mU/L , P = 0.041 ; 0.600.05 vs. 0.880.06 , P = 0.039 ; ( 0.120.07 ) g/L vs. ( 0.350.12 ) g/L , P = 0.028 ] .
RESULTS	Postoperative infectious complication morbidity was significantly lower in treatment group as compared to control group [ 18.8 % ( 9/48 ) vs. 39.6 % ( 19/48 ) , P = 0.025 ] .
CONCLUSIONS	Microbial immune enteral nutrition composed of probiotics , deep sea fish oil , glutamine and nutrison can improve the immune status , decrease the level of insulin resistance , and reduce the incidence of postoperative infectious complication for patients with abdominal infection due to upper gastrointestinal perforation .

###24637411
BACKGROUND	The addition of highly purified eicosapentaenoic acid ( EPA ) to statin therapy prevents cardiovascular events .
BACKGROUND	However , the impact of this treatment on vulnerable plaques remains unclear .
BACKGROUND	The aim of this study was to assess the impact of adding EPA to a standard statin therapy on vulnerable plaques by serial optical coherence tomography ( OCT ) .
METHODS	Forty-nine non-culprit thin-cap fibroatheroma ( TCFA ) lesions in 30 patients with untreated dyslipidemia were included .
METHODS	Patients were randomly assigned to EPA ( 1800 mg/day ) + statin ( 23 TCFA , 15 patients ) or statin only ( 26 TCFA , 15 patients ) treatment .
METHODS	The statin ( rosuvastatin ) dose was adjusted to achieve a target low-density lipoprotein ( LDL ) level of < 70 mg/dL .
METHODS	Post-percutaneous intervention and 9-month follow-up OCT were performed to evaluate morphological changes of TCFAs .
METHODS	The EPA/arachidonic acid ( EPA/AA ) ratio and pentraxin-3 ( PTX3 ) levels were also evaluated .
RESULTS	Despite similar follow-up LDL levels , the EPA + statin group had higher EPA/AA ratios and lower PTX3 levels than the statin group .
RESULTS	OCT analysis showed that the EPA + statin group had a greater increase in fibrous-cap thickness , with a greater decrease in lipid arc and lipid length .
RESULTS	Macrophage accumulation was less frequently detected in the EPA + statin group than in the statin group at follow-up .
RESULTS	When the patients were categorized according to their follow-up PTX3 tertiles , fibrous-cap thickness showed significant increase , and the incidence of macrophages accumulation decreased with lower PTX3 levels .
CONCLUSIONS	The concomitant use of EPA and rosuvastatin may stabilize vulnerable plaques better than the statin alone , possibly by suppressing arterial inflammation .

###24733354
OBJECTIVE	The American Board of Internal Medicine Foundation Choosing Wisely Campaign recommends against the use of benzodiazepine drugs for adults 65 years and older .
OBJECTIVE	The effect of direct patient education to catalyze collaborative care for reducing inappropriate prescriptions remains unknown .
OBJECTIVE	To compare the effect of a direct-to-consumer educational intervention against usual care on benzodiazepine therapy discontinuation in community-dwelling older adults .
METHODS	Cluster randomized trial ( EMPOWER [ Eliminating Medications Through Patient Ownership of End Results ] study [ 2010-2012 , 6-month follow-up ] ) .
METHODS	Community pharmacies were randomly allocated to the intervention or control arm in nonstratified , blocked groups of 4 .
METHODS	Participants ( 303 long-term users of benzodiazepine medication aged 65-95 years , recruited from 30 community pharmacies ) were screened and enrolled prior to randomization : 15 pharmacies randomized to the educational intervention included 148 participants and 15 pharmacies randomized to the `` wait list '' control included 155 participants .
METHODS	Participants , physicians , pharmacists , and evaluators were blinded to outcome assessment .
METHODS	The active arm received a deprescribing patient empowerment intervention describing the risks of benzodiazepine use and a stepwise tapering protocol .
METHODS	The control arm received usual care .
METHODS	Benzodiazepine therapy discontinuation at 6 months after randomization , ascertained by pharmacy medication renewal profiles .
RESULTS	A total of 261 participants ( 86 % ) completed the 6-month follow-up .
RESULTS	Of the recipients in the intervention group , 62 % initiated conversation about benzodiazepine therapy cessation with a physician and/or pharmacist .
RESULTS	At 6 months , 27 % of the intervention group had discontinued benzodiazepine use compared with 5 % of the control group ( risk difference , 23 % [ 95 % CI , 14 % -32 % ] ; intracluster correlation , 0.008 ; number needed to treat , 4 ) .
RESULTS	Dose reduction occurred in an additional 11 % ( 95 % CI , 6 % -16 % ) .
RESULTS	In multivariate subanalyses , age greater than 80 years , sex , duration of use , indication for use , dose , previous attempt to taper , and concomitant polypharmacy ( 10 drugs or more per day ) did not have a significant interaction effect with benzodiazepine therapy discontinuation .
CONCLUSIONS	Direct-to-consumer education effectively elicits shared decision making around the overuse of medications that increase the risk of harm in older adults .
BACKGROUND	clinicaltrials.gov Identifier : NCT01148186 .

###25693332
BACKGROUND	Efficacy and safety of sugammadex in reversing neuromuscular block induced by rocuronium or vecuronium were investgated in Japanese patients .
METHODS	We studied 98 Japanese patients undergoing surgery requiring general anesthesia .
METHODS	Patients were allocated randomly to receive intubation dose of rocuronium or vecuronium .
METHODS	During surgery , patients received additional doses of rocuronium or vecuronium for maintenance of moderate block .
METHODS	At T2 reappearance sugammadex 0-4 .0 mg .
METHODS	kg-1 was administered .
METHODS	The neuromuscular block was monitored with acceleromyography using TOF stimuli .
METHODS	Sevoflurane was administered to all treatment groups after intubation .
RESULTS	For the rocuronium-induced neuromuscular block , the mean recovery time of the T4/T1 ratio to 0.9 decreased from 82.1 min in the placebo group to 1.8 min in the 4.0 mg .
RESULTS	kg-1 sugammadex group .
RESULTS	For the vecuronium-induced neuromuscular block , it decreased from 83.2 min in the placebo group to 2.1 min in the sugammadex 4.0 mg .
RESULTS	kg-1 group .
RESULTS	Plasma concentrations of sugammadex were approximately dose proportional over the dose range of 0.5 to 4.0 mg .
RESULTS	kg-1 and independent of the neuromuscular blocking agents used .
RESULTS	No clinical evidence of recurarization or residual curarization was observed .
CONCLUSIONS	The efficacy and safety of sugammadex were confirmed in Japanese surgical patients .

###25441954
BACKGROUND	The plasma 25-hydroxyvitamin D response to supplementation with vitamin D varies widely , but vitamin D absorption differences based on diet composition is poorly understood .
OBJECTIVE	We tested the hypotheses that absorption of vitamin D-3 is greater when the supplement is taken with a meal containing fat than with a fat-free meal and that absorption is greater when the fat in the meal has a higher monounsaturated-to-polyunsaturated fatty acid ratio ( MUFA : PUFA ) .
METHODS	Open , three-group , single-dose vitamin D-3 comparative absorption experiment .
METHODS	Our 1-day study was conducted in 50 healthy older men and women who were randomly assigned to one of three meal groups : fat-free meal , and a meal with 30 % of calories as fat with a low ( 1:4 ) and one with a high ( 4:1 ) MUFA : PUFA .
METHODS	After a 12-hour fast , all subjects took a single 50,000 IU vitamin D-3 supplement with their test breakfast meal .
METHODS	Plasma vitamin D-3 was measured by liquid chromatography-mass spectrometry before and 10 , 12 ( the expected peak ) , and 14 hours after the dose .
METHODS	Means were compared with two-tailed t tests for independent samples .
METHODS	Group differences in vitamin D-3 absorption across the measurement time points were examined by analysis of variance with the repeated measures subcommand of the general linear models procedure .
RESULTS	The mean peak ( 12-hour ) plasma vitamin D-3 level after the dose was 32 % ( 95 % CI 11 % to 52 % ) greater in subjects consuming fat-containing compared with fat-free meals ( P = 0.003 ) .
RESULTS	Absorption did not differ significantly at any time point in the high and low MUFA and PUFA groups .
CONCLUSIONS	The presence of fat in a meal with which a vitamin D-3 supplement is taken significantly enhances absorption of the supplement , but the MUFA : PUFA of the fat in that meal does not influence its absorption .

###26060460
BACKGROUND	It is not clear whether demographic or pterygium characteristics or limbal stem cell deficiency determine pterygium recurrence after surgery .
OBJECTIVE	To determine whether the demographic , pterygium characteristics , or limbal stem cell deficiency determine pterygium recurrence after excision .
METHODS	Of 190 patients operated and followed-up for 6 months , 101 and 89 underwent free conjunctival autotransplant ( CAT ) or limbal conjunctival autotransplant ( LCAT ) respectively .
METHODS	The age , gender , occupation , grade of pterygium extent and degree of fleshiness , and laterality were compared between recurrent and no recurrent pterygia .
METHODS	Multivariate analysis was performed to determine the predictors of pterygium recurrence .
METHODS	Recurrence rates after surgery were compared between CAT and LCAT .
RESULTS	The age range of the 190 patients was 22-65 years , mean SD 46.4 10.8 years .
RESULTS	Pterygium recurred in 52 ( 27.4 % ) .
RESULTS	Thirty-nine ( 75 % ) of 52 patients with pterygia that recurred were aged < 50 years ( young ) vs. 72 ( 52 % ) of 138 young patients with no recurrence ; odds ratio ( OR ) = 1.54 ; 95 % confidence interval ( 95 % CI ) = 0.70-3 .36 ; p = 0.28 .
RESULTS	Thirty-one ( 60 % ) of 52 participants with post-surgical recurrent pterygia had large pre-operative pterygium ( grade 3 ) vs. 130 ( 94 % ) of 138 patients with large pterygia that did not recur ; OR = 0.11 ; 95 % CI = 0.04-0 .28 ; p < 0.001 .
RESULTS	Of 101 patients undergoing CAT , 29 ( 28.7 % ) experienced recurrence vs. 23 ( 25.8 % ) of 89 undergoing LCAT ; p = 0.66 .
CONCLUSIONS	Young age seems to be associated with pterygium recurrence after excision followed by conjunctival graft .
CONCLUSIONS	Large pterygia were protective .

###24342552
OBJECTIVE	To compare the efficacy of a regimen combining mental practice ( MP ) with overground training ( OT ) with the efficacy of a regimen consisting of OT only on gait velocity and lower extremity motor outcomes in individuals with chronic ( > 12mo postinjury ) , incomplete spinal cord injury ( SCI ) .
METHODS	Randomized , controlled , single-blinded study .
METHODS	Outpatient rehabilitation laboratories .
METHODS	Subjects with chronic , incomplete SCI ( N = 18 ) .
METHODS	Subjects were randomly assigned to receive ( 1 ) OT only , occurring 3d/wk for 8 weeks ; or ( 2 ) OT augmented by MP ( MP + OT ) , during which randomly assigned subjects listened to an MP audio recording directly after OT sessions .
METHODS	Subjects were administered a test of gait velocity as well as the Tinetti Performance Oriented Mobility Assessment , Spinal Cord Injury Independence Measure , and Satisfaction With Life Scale on 2 occasions before intervention , 1 week after intervention , and 12 weeks after intervention .
RESULTS	A significant increase in gait velocity was exhibited across subjects at both 1 week posttherapy ( P = .005 ) and at 12 weeks posttherapy ( P = .006 ) .
RESULTS	However , no differences were seen in intervention response at either 1 or 12 weeks postintervention among subjects in the MP + OT group versus the OT-only group .
CONCLUSIONS	OT was associated with significant gains in gait velocity , and these gains were not augmented by further addition of MP .

###24625291
BACKGROUND	Gastric ulceration is highly prevalent in horses , and there is a large commercial market for feed-additives and non-licenced products that claim effect for prevention and treatment of gastric ulceration .
BACKGROUND	ImproWin has been used as a feed additive in horses with anecdotal evidence that it may have some positive effects on gastric ulceration.The aim of this study was to investigate the effect of ImproWin treatment on spontaneously occurring gastric ulcers of the squamous mucosa in Standardbred and Coldblooded trotting racehorses .
BACKGROUND	The study was performed as a randomised , double-blinded , single centre study with stratified semi cross-over design with breed as stratification factors .
BACKGROUND	The horses were clinically and endoscopically examined prior to start and after three weeks of treatment .
BACKGROUND	The ulcerations were scored in accordance with Equine Gastric Ulcer Council ( EGUC ) recommendations on a 5 point scale and on a 10 cm Visual Analogue Scale ( VAS ) .
BACKGROUND	The patients were responder-classified after 3 weeks .
BACKGROUND	Responders in need of ulcer treatment were randomly allocated to 2 or 4 weeks of additional treatment .
BACKGROUND	Non-responders to placebo were crossed to ImproWin .
RESULTS	The 5-point EGUC score and VAS recorded score was significantly reduced ( P0 .01 ) in both groups after 3 weeks of treatment .
RESULTS	From 3 weeks to the end of treatment the score was further significantly reduced in the ImproWin group ( P0 .05 ) .
RESULTS	At the end of treatment , 78 % in the ImproWin group and 54.8 % in the placebo group were classified as responders .
RESULTS	The difference was significant ( P = 0.04 ) .
CONCLUSIONS	ImproWin may aid the healing process of ulcers of the gastric squamous mucosa of trotters .

###25922233
BACKGROUND	The oral neurokinin-1 antagonist aprepitant is recommended in several guidelines for preventing chemotherapy-induced nausea & vomiting ( CINV ) due to highly emetogenic cancer chemotherapy .
BACKGROUND	Little is known about the feasibility and safety of aprepitant in patients treated with oxaliplatin .
METHODS	In this multicentre , open label , randomised , phase 3 trial , we recruited patients with colorectal cancer who underwent an oxaliplatin-based chemotherapy .
METHODS	Patients were centrally randomised in a 1:1 ratio to the control group ( 5-HT3-receptor antagonist + dexamethasone ) or aprepitant group ( 5-HT3-receptor antagonist + dexamethasone + aprepitant or fosaprepitant ) in the first course .
METHODS	All patients were treated with aprepitant/fosaprepitant therapy in the second course .
METHODS	The primary end-point was the proportion of patients with no emesis .
RESULTS	A total of 413 patients entered this clinical trial from 25 centres in Japan .
RESULTS	Significantly more patients in the aprepitant group achieved no vomiting overall and delayed phase than those in the control group ( 95.7 % versus 83.6 % , and 95.7 % versus 84.7 % , respectively ) .
RESULTS	The aprepitant group also had statistically significantly higher percentages of no significant nausea , complete response and complete protection than the control group overall .
RESULTS	In the control group , the percentages of no vomiting were higher in the second cycle than in the first cycle .
RESULTS	The incidence of vomiting occurred day 7 or later was significantly higher in the control group compared with the aprepitant group .
RESULTS	Other adverse events were not significant between the groups .
CONCLUSIONS	The aprepitant therapy was more effective than the control therapy for prevention of CINV in colorectal cancer patients receiving an oxaliplatin-based regimen .

###25460265
OBJECTIVE	Research has documented the very brief exposure ( VBE ) effect : the reduction of phobic fear by continuous presentation of masked phobic pictures .
OBJECTIVE	In prior studies , phobic participants approached a live tarantula immediately after the masked stimuli were presented .
OBJECTIVE	This study tested the hypothesis that VBE would reduce phobic avoidance of the tarantula 24 h later .
METHODS	86 spider-phobic participants were identified with a fear questionnaire and Behavioral Avoidance Test ( BAT ) with a live tarantula indicative of a DSM-IV diagnosis of Specific Phobia .
METHODS	One week later , they were randomly assigned in double-blind fashion to presentation of a continuous series of 25 trials of masked images of either spiders or flowers ( 33-ms each ) , i.e. , to VBE or control exposure .
METHODS	The participants gave subjective distress ratings just before and after these exposures .
METHODS	Then they engaged in the BAT again either immediately thereafter or 24 h later to measure changes in avoidance of the tarantula .
RESULTS	Masked images of spiders reduced avoidance of the tarantula both immediately after exposure and 24 h later without causing subjective distress .
RESULTS	The effect sizes at these two time points did not significantly differ from each other .
CONCLUSIONS	We did not manipulate awareness of the spider images by presenting them unmasked to a third group .
CONCLUSIONS	Conclusions about the effect of awareness of the stimuli can not be drawn .
CONCLUSIONS	VBE induces a process of fear reduction before phobic individuals engage in in vivo exposure , which is more distressing .
CONCLUSIONS	Thus , VBE may help phobic-resistant individuals start treatment more gradually .

###24268209
BACKGROUND	In patients with ST-segment elevation myocardial infarction ( STEMI ) triaged to primary percutaneous coronary intervention ( PCI ) , anticoagulation often is initiated in the ambulance during transfer to a PCI site .
BACKGROUND	In this prehospital setting , bivalirudin has not been compared with standard-of-care anticoagulation .
BACKGROUND	In addition , it has not been tested in conjunction with the newer P2Y12 inhibitors prasugrel or ticagrelor .
METHODS	EUROMAX is a randomized , international , prospective , open-label ambulance trial comparing bivalirudin with standard-of-care anticoagulation with or without glycoprotein IIb/IIIa inhibitors in 2200 patients with STEMI and intended for primary percutaneous coronary intervention ( PCI ) , presenting either via ambulance or to centers where PCI is not performed .
METHODS	Patients will receive either bivalirudin given as a 0.75 mg/kg bolus followed immediately by a 1.75-mg / kg per hour infusion for 30 minutes prior to primary PCI and continued for 4 hours after the end of the procedure at the reduced dose of 0.25 mg/kg per hour , or heparins at guideline-recommended doses , with or without routine or bailout glycoprotein IIb/IIIa inhibitor treatment according to local practice .
METHODS	The primary end point is the composite incidence of death or non-coronary-artery-bypass-graft related protocol major bleeding at 30 days by intention to treat .
CONCLUSIONS	The EUROMAX trial will test whether bivalirudin started in the ambulance and continued for 4 hours after primary PCI improves clinical outcomes compared with guideline-recommended standard-of-care heparin-based regimens , and will also provide information on the combination of bivalirudin with prasugrel or ticagrelor .

###24411003
BACKGROUND	Few clinical studies have focused on the efficacy of lipid-lowering therapies in patients 65 years .
METHODS	After stabilization on atorvastatin 10 mg , hypercholesterolemic subjects 65 years at high/very high risk for CHD and not at LDL-C < 1.81 mmol/L ( with atherosclerotic vascular disease [ AVD ] ) or < 2.59 mmol/L ( without AVD ) were randomized to ezetimibe 10 mg plus atorvastatin 10 mg or uptitration to atorvastatin 20 mg ( 6 weeks ) followed by uptitration to 40 mg ( additional 6 weeks ) .
METHODS	A post-hoc analysis compared between-group differences in percent attainment of individual and combined LDL-C , non-HDL-C and Apo B targets based on recommendations from 2012 European and Canadian Cardiovascular Society ( CCS ) guidelines for dyslipidemia treatment .
RESULTS	Atorvastatin 10 mg plus ezetimibe produced significantly greater attainment of LDL-C , non-HDL-C , and Apo B individual and dual/triple targets vs. atorvastatin 20 mg for the entire cohort and very high-risk groups at 6 weeks .
RESULTS	After 12 weeks , very high-risk subjects maintained significantly greater achievement of LDL-C < 1.8 mmol/L ( 47 % vs. 35 % ) , non-HDL-C < 2.6 mmol/L ( 63 % vs. 53 % ) and Apo B < 0.8 g/L ( 47 % vs. 38 % ) single targets and dual/triple targets with atorvastatin 10 mg plus ezetimibe vs. atorvastatin 40 mg , while attainment of European target for high-risk subjects was generally similar for both treatments .
RESULTS	Achievement of Canadian targets was significantly greater with combination therapy vs. atorvastatin 20 mg ( 6 weeks ) or atorvastatin 40 mg ( 12 weeks ) .
CONCLUSIONS	Atorvastatin 10 mg plus ezetimibe provided more effective treatment than uptitration to atorvastatin 20/40 mg for attainment of most European and Canadian guideline-recommended lipid targets in older at-risk patients .
BACKGROUND	ClinicalTrials.gov identifier NCT00418834 .

###25212646
BACKGROUND	Aspiration thrombectomy in ST-segment elevation myocardial infarction is recommended by current guidelines based on several randomized trials .
BACKGROUND	There are no trials assessing thrombectomy in non-ST-segment elevation myocardial infarction ( NSTEMI ) patients .
OBJECTIVE	The TATORT-NSTEMI ( Thrombus Aspiration in Thrombus Containing Culprit Lesions in Non-ST-Elevation Myocardial Infarction ) trial sought to assess the effect of aspiration thrombectomy on microvascular injury in patients with NSTEMI compared with standard percutaneous coronary intervention ( PCI ) .
METHODS	This prospective , controlled , multicenter study randomized 440 patients to adjunctive thrombectomy ( n = 221 ) compared with conventional PCI ( n = 219 ) in NSTEMI patients with thrombus-containing lesions .
METHODS	The primary endpoint of the extent of microvascular obstruction ( MO ) in the percentage of left ventricular mass ( % LV ) was assessed by cardiac magnetic resonance imaging within 4 days .
METHODS	Secondary endpoints included infarct size , myocardial salvage index , and angiographic parameters including myocardial blush grade and Thrombolysis In Myocardial Infarction flow grade .
METHODS	The combined clinical endpoint consisted of death , reinfarction , target vessel revascularization , and new congestive heart failure within 6 months .
RESULTS	The primary endpoint of MO was not different between the thrombectomy and the standard PCI group with 2.0 % LV ( interquartile range [ IQR ] : 0.8 to 4.1 ) versus 1.4 % LV ( IQR : 0.7 to 2.6 ) ( p = 0.17 ) .
RESULTS	Similarly , no significant differences were observed for infarct size ( 8.6 % LV ; IQR : 4.0 to 14.7 vs. 7.4 % LV ; IQR : 4.1 to 13.1 ; p = 0.46 ) , myocardial salvage index ( 63.3 ; IQR : 35.4 to 87.2 vs. 65.6 ; IQR : 46.9 to 82.6 ; p = 0.45 ) , or angiographic parameters such as blush grade ( p = 0.63 ) and Thrombolysis In Myocardial Infarction flow grade ( p = 0.66 ) .
RESULTS	Clinical follow-up at 6 months revealed no differences in the combined clinical endpoints ( p = 0.22 ) .
CONCLUSIONS	Aspiration thrombectomy in conjunction with PCI in NSTEMI with a thrombus-containing lesion does not lead to a reduction in MO. ( Thrombus Aspiration in Thrombus Containing Culprit Lesions in Non-ST-Elevation Myocardial Infarction [ TATORT-NSTEMI ] ; NCT01612312 ) .

###24341437
OBJECTIVE	The aim of this study was to examine the relationship between mastery motivation and individual and environmental characteristics in school-aged children with congenital hemiplegia .
METHODS	Forty-eight child-caregiver dyads ( children 's mean age 7y 11mo , SD 2y 4mo ; 33 males , 15 females ; Manual Ability Classification System [ MACS ] level I , n = 25 , and level II , n = 23 ; predominant motor type spastic hemiplegia , n = 47 ) were recruited to this cross-sectional study .
METHODS	Children were assessed using the Melbourne Assessment of Unilateral Upper Limb Function ( MUUL ) and the Assisting Hand Assessment .
METHODS	Caregivers completed the Dimensions of Mastery Questionnaire , the Parenting Scale , and a demographic questionnaire .
RESULTS	Consistent and positive parental disciplinary practices were associated with higher total motivation ( p = 0.006 ) and instrumental aspect scores ( p = 0.009 ) .
RESULTS	Children with siblings and from single-parent families experienced greater negative reactions to failure ( p = 0.006 ) .
RESULTS	Children from two-parent families ( p = 0.018 ) and with better bimanual performance ( p = 0.015 ) demonstrated greater object-oriented persistence .
RESULTS	Age , sex , limitations in manual ability ( MACS ) , and movement and body function of the impaired limb ( MUUL ) did not contribute significantly to mastery motivation .
CONCLUSIONS	Inconsistent , excessively lax , and verbose parenting practices may discourage children from persevering with challenging tasks .
CONCLUSIONS	Functional parenting styles , positive discipline practices , and autonomy-supportive strategies for task engagement should be encouraged when intervening with children with cerebral palsy .
CONCLUSIONS	Parents should be supported to engage in these practices in all aspects of daily activities .

###24868564
OBJECTIVE	To compare the effect of wavefront-guided ( WFG ) and wavefront-optimized ( WFO ) photorefractive keratectomy ( PRK ) on patient perceived quality of vision .
METHODS	Seventy-one patients ( 142 eyes ) were enrolled in this prospective , randomized , fellow eye controlled study .
METHODS	One eye was randomized to undergo WFG PRK treatment by the AMO Visx CustomVue S4 IR excimer laser system ( Abbott Medical Optics , Inc. , Santa Clara , CA ) and the fellow eye received WFO PRK treatment by the Alcon Allegretto Wave Eye-Q 400 Hz excimer laser system ( Alcon Laboratories , Inc. , Fort Worth , TX ) .
METHODS	Patients answered questionnaires on their visual symptoms and quality of vision preoperatively and at 1 , 3 , 6 , and 12 months after surgery .
RESULTS	Patients in both groups reported better vision compared to baseline from 3 months onward ( mean change in score of 1.56 to 2.51 in the WFO group and 1.54 to 2.28 in the WFG group , P .003 ) .
RESULTS	Both groups experienced less nighttime glare from 6 months onward ( P .030 ) .
RESULTS	Halos , double vision , and visual clarity were initially worse ( P .025 ) but not significantly different after 1 month .
RESULTS	Haze and fluctuating vision resolved after 3 months .
RESULTS	Visual symptoms were similar between the two groups at all times ( P .059 ) except at 6 months , when patients felt their WFG eyes had more excellent vision ( P = .029 ) .
RESULTS	A composite of all symptoms was also similar between the groups until 12 months when patients had fewer symptoms in their WFO eye ( P = .044 ) .
CONCLUSIONS	One year after surgery , patient self-reported visual symptoms were not significantly different in eyes receiving WFG or WFO PRK .
CONCLUSIONS	However , the average of all symptoms was lower in eyes receiving wavefront-optimized treatment .

###25088843
BACKGROUND	Because of lack of information regarding timing of stroke , patients who suffer stroke during sleep are generally ineligible for intravenous thrombolysis , although many of these patients could potentially recover with this treatment .
BACKGROUND	Magnetic resonance image findings with positive diffusion-weighted imaging and no marked parenchymal hyperintensity on fluid-attenuated inversion recovery ( negative pattern ) can identify acute ischemic stroke patients within 45h from symptom onset .
OBJECTIVE	The THrombolysis for Acute Wake-up and unclear-onset Strokes with alteplase at 06mg/kg trial aims to determine the efficacy and safety of intravenous thrombolysis with alteplase at 06mg/kg body weight , the approved dose for Japanese stroke patients , using magnetic resonance image-based selection in ischemic stroke patients with unclear time of symptom onset , and compare findings with standard treatment .
METHODS	This is an investigator-initiated , multicenter , prospective , randomized , open-treatment , blinded-end-point clinical trial .
METHODS	The design is similar to the Efficacy and Safety of MRI-based Thrombolysis in Wake-up Stroke trial .
METHODS	Patients with unclear-onset time of stroke symptoms beyond 45h and within 12h after the time of the last-known-well period and within 45h after symptom recognition , who showed a negative fluid-attenuated inversion recovery pattern , are randomized to either intravenous thrombolysis or standard treatment .
RESULTS	The primary efficacy end-point is modified Rankin Scale 0-1 at 90 days .
RESULTS	The safety outcome measures are symptomatic intracranial hemorrhage at 22-36h , and major bleeding and mortality at 90 days .
CONCLUSIONS	This trial may help determine if low-dose alteplase at 06mg/kg should be recommended as a routine clinical strategy for ischemic stroke patients with unclear-onset time .

###25428268
BACKGROUND	Ulcers of the heel in diabetes are the source of considerable suffering and cost .
BACKGROUND	In the absence of specific treatments , it has been suggested that removable , lightweight fibreglass heel casts may both promote healing and reduce discomfort and pain .
BACKGROUND	The aim of the study is to assess the effectiveness and cost-effectiveness of fibreglass heel casts in the management of heel ulcers .
METHODS	This is an observer-blind , randomised controlled trial in which participants with diabetes and heel ulcers ( NPUAP/EPUAP grades 2 , 3 or 4 and present for 2 or more weeks ) are randomised to receive either usual care plus lightweight fibreglass heel casts or usual care alone .
METHODS	Randomisation is undertaken by random number sequence generation incorporated as part of the electronic case record form , and is stratified by both ulcer area ( less than versus equal to or greater than 1 cm ( 2 ) ) and NPUAP/EPUAP grade .
METHODS	Participants are followed every two weeks until healing or for 24 weeks .
METHODS	The primary outcome measure is healing at or before 24 weeks and maintained for 4 weeks .
METHODS	Secondary outcomes include ( i ) ulcer-related outcomes : time to healing , change in ulcer area , minor and major amputation , secondary infection and ( ii ) patient-related outcomes : local pain , mood and function ( EQ-5D ) , impact of the ulcer ( Cardiff Wound Impact Schedule ) and survival .
METHODS	Cost-effectiveness will be assessed using a decision analytic model to estimate costs from the perspective of the UK NHS and personal social services and health outcomes , including percent healing and Quality Adjusted Life Years gained.Safety will be documented as adverse and serious adverse device effects .
CONCLUSIONS	If it is possible to confirm significant clinical benefit and/or cost-effectiveness , this would have direct implications for the management of this distressing and costly complication of diabetes
BACKGROUND	ISRCTN62524796 Registered 29 March 2011 .

###24276074
OBJECTIVE	To determine if abobotulinumtoxin A ( AboBTXA ) is an effective treatment for interstitial cystitis/bladder pain syndrome ( IC/BPS ) .
METHODS	We performed a double-blind study of 54 women with severe , refractory IC from three referral centres whom we randomly allocated to treatment with hydrodistension + injection of normal saline or to hydrodistension + injection with AboBTXA .
METHODS	The O'Leary-Sant questionnaire consists of problem ( OLS-PI ) and symptom ( OLS-PI ) index scores , and bladder diary data were compared between AboBTXA and control patients at baseline and at 3 months of follow-up .
METHODS	Measurements were made beyond 3 months , but no further randomised comparison was possible due to the ability of nonresponsive patients in either group to have AboBTXA treatment .
RESULTS	Complete data were available in 50 patients , and in both groups , OLS questionnaires showed improvement at 3 months .
RESULTS	Only the OLS-PI was improved in the AboBTXA group ( p = 0.04 ) .
RESULTS	At 3 months , no difference was found in either OLS-SI or total OLS score .
RESULTS	Twelve patients had urinary tract infection ( UTI ) treated during the follow-up period , which confounded results .
RESULTS	In the 38 patients without UTI , there was improvement in total OLS score ( p = 0.02 ) , OLS-PI ( 0.08 ) , and OLS-SI ( p = 0.008 ) for the AboBTXA group at 3 months .
RESULTS	Only five AboBTXA compared with two control patients had a 50 % reduction in OLS score .
CONCLUSIONS	For chronic refractory IC/BPS patients , AboBTXA was associated with no overall improvement in total OLS score , although significant benefit was noted in a small number of patients .
CONCLUSIONS	The absence of posttreatment UTI was associated with a better response to AboBTXA .

###24329543
OBJECTIVE	To evaluate the baseline impact of episode type ( manic vs. mixed ) , defined using DSM-IV-TR criteria , in bipolar I disorder ( BD-I ) on health-related quality of life ( HRQoL ) , and to investigate the differential effect of asenapine vs. placebo and olanzapine on HRQoL in BD-I patients with mixed episodes .
METHODS	In two identically designed 3 week , randomized , double-blind , flexible-dose , placebo - and olanzapine-controlled trials of asenapine , HRQoL was assessed using the 36-item Short-Form Health Survey ( SF-36v2 ) administered at baseline and endpoint .
METHODS	In addition to evaluating the impact of clinical presentation ( manic vs. mixed episodes ) on baseline HRQoL , the impact of treatment intervention on HRQoL was assessed via analysis of covariance models at study endpoint , with center and treatment-by-diagnosis interaction as fixed effect and baseline score as covariates .
RESULTS	A total of 960 BD-I patients ( asenapine : 372 ; olanzapine : 391 ; placebo : 197 ) were included in the two studies .
RESULTS	The observed burden of disease on HRQoL was substantial compared to general US population norms , particularly in patients experiencing mixed episodes .
RESULTS	The greatest impairments were observed in the mental domains of HRQoL ( Mental Component Summary scores : mixed = 31.9 ; manic = 42.8 ) .
RESULTS	For patients with mixed episodes , when compared to olanzapine , asenapine treatment was associated with improvements noted in every domain , which did not reach statistical significance except for Vitality ( asenapine = 55.0 , olanzapine = 51.3 ; p = 0.014 ) and Role-Emotional ( asenapine = 44.8 , olanzapine = 40.3 ; p = 0.020 ) .
RESULTS	Compared to placebo patients with mixed episodes , asenapine treatment provided significant improvements ( p < 0.05 ) in Bodily Pain ( asenapine = 50.9 , placebo = 45.9 ) , Social Functioning ( asenapine = 44.1 , placebo = 39.6 ) and Mental Health ( asenapine = 46.6 , placebo = 42.7 ) by Week 3 ; by comparison , olanzapine treatment did not lead to significant improvements in any domain of HRQoL compared to placebo .
CONCLUSIONS	Post-hoc analyses of two trials showed that BD-I patients with mixed episodes reported considerable impairments in HRQoL compared to patients with manic episodes .
CONCLUSIONS	At 3 weeks , in patients with mixed episodes , asenapine was shown to lead to significant improvements in HRQoL compared to olanzapine and placebo .
CONCLUSIONS	Results from these post-hoc analyses should be confirmed in prospective studies .
BACKGROUND	NCT00159744 , NCT00159796 .

###25352050
BACKGROUND	Low back pain is a common , disabling musculoskeletal disorder in both developing and developed countries .
BACKGROUND	Although often recommended , the potential efficacy of massage therapy in general , and Chinese massage ( tuina ) in particular , for relief of chronic low back pain ( CLBP ) has not been fully established due to inadequate sample sizes , low methodological quality , and subclinical dosing regimens of trials to date .
BACKGROUND	Thus , the purpose of this randomized controlled trial ( RCT ) is to evaluate the comparative effectiveness of tuina massage therapy versus conventional analgesics for CLBP .
METHODS	The present study is a single center , two-arm , open-label RCT .
METHODS	A total of 150 eligible CLBP patients will be randomly assigned to either a tuina treatment group or a conventional drug control group in a 1:1 ratio .
METHODS	Patients in the tuina group receive a 20 minutes , 4-step treatment protocol which includes both structural and relaxation massage , administered in 20 sessions over a period of 4 weeks .
METHODS	Patients in the conventional drug control group are instructed to take a specific daily dose of ibuprofen .
METHODS	The primary outcome measure is the change from baseline back pain and function , measured by Roland-Morris Disability Questionnaire , at two months .
METHODS	Secondary outcome measures include the visual analogue scale , Japanese orthopedic association score ( JOAS ) , and McGill pain questionnaire .
CONCLUSIONS	The design and methodological rigor of this trial will allow for collection of valuable data to evaluate the efficacy of a specific tuina protocol for treating CLBP .
CONCLUSIONS	This trial will therefore contribute to providing a solid foundation for clinical treatment of CLBP , as well as future research in massage therapy .
BACKGROUND	This trial was registered with ClinicalTrials.gov of the National Institute of Health on 22 October 2013 ( http://NCT01973010 ) .

###24894436
BACKGROUND	Chronic pain is common among the older population .
BACKGROUND	A literature review on pain management program showed that exercise , yoga , massage therapy , Tai Chi , and music therapy could significantly reduce pain .
BACKGROUND	In spite of the proven benefits of pain management programs , these intervention programs were effective only in the short term , and older adults would resume their old habits .
BACKGROUND	It has been suggested that interventions comprising some type of social support have great potential to increase the participation of older adults .
BACKGROUND	Therefore , we propose the inclusion of peer volunteers in an integrated pain management program to relieve pain among frail older adults .
BACKGROUND	This study aims to explore the effectiveness of an integrated pain management program supplemented with peer volunteers in improving pain intensity , functional mobility , physical activity , loneliness levels , happiness levels , and the use of non-pharmacological pain-relieving methods among frail older adults with chronic pain .
METHODS	We intend to recruit 30 nursing home residents and 30 peer volunteers from the Institute of Active Ageing in Hong Kong in a group trial for an 8-week group-based integrated pain management program .
METHODS	There will be 16 sessions , with two 1-hour sessions each week.The primary outcome will be pain levels , while secondary outcomes will be assessed according to functional mobility , physical activity , loneliness levels , happiness levels , the use of non-pharmacological pain-relieving methods , and through a questionnaire for volunteers .
CONCLUSIONS	In view of the high prevalence of chronic pain among older adults and its adverse impacts , it is important to provide older adults with tools to control their pain .
CONCLUSIONS	We propose the use of peer volunteers to enhance the effects of an integrated pain management program .
CONCLUSIONS	It is expected that pain can be reduced and improvements can be achieved among older adults in the areas of physical activity , functional mobility , loneliness levels , happiness levels , and the use of non-pharmacological pain relieving methods .
CONCLUSIONS	Using these results , we will assess the need to conduct a larger study with a randomized controlled design .
BACKGROUND	This trial was registered on 24 February 2014 at the Australian New Zealand Clinical Trials Registry ( ANZCTR ) with the trial number : ACTRN12614000195651 .

###24530788
BACKGROUND	Moderate alcohol consumption is associated with a decrease in cardiovascular risk , but fermented beverages seem to confer greater cardiovascular protection due to their polyphenolic content .
BACKGROUND	Circulating endothelial progenitor cells ( EPC ) are bone-marrow-derived stem cells with the ability to repair and maintain endothelial integrity and function and are considered as a surrogate marker of vascular function and cumulative cardiovascular risk .
BACKGROUND	Nevertheless , no study has been carried out on the effects of moderate beer consumption on the number of circulating EPC in high cardiovascular risk patients .
OBJECTIVE	To compare the effects of moderate consumption of beer , non-alcoholic beer and gin on the number of circulating EPC and EPC-mobilizing factors .
METHODS	In this crossover trial , 33 men at high cardiovascular risk were randomized to receive beer ( 30 g alcohol/d ) , the equivalent amount of polyphenols in the form of non-alcoholic beer , or gin ( 30 g alcohol/d ) for 4 weeks .
METHODS	Diet and physical exercise were carefully monitored .
RESULTS	The number of circulating EPC and EPC-mobilizing factors were determined at baseline and after each intervention .
RESULTS	After the beer and non-alcoholic beer interventions , the number of circulating EPC significantly increased by 8 and 5 units , respectively , while no significant differences were observed after the gin period .
RESULTS	In correlation , stromal cell derived factor 1 increased significantly after the non-alcoholic and the beer interventions .
CONCLUSIONS	The non-alcoholic fraction of beer increases the number of circulating EPC in peripheral blood from high cardiovascular risk subjects .
BACKGROUND	http://www.controlled-trials.com/ISRCTN95345245 ISRCTN95345245 .

###25611939
BACKGROUND	School-based programs , such as Playworks , that guide students in organized activities during recess and make improvements to the recess play yard may lead to significant increases in physical activity-especially for girls .
BACKGROUND	This study builds on past research by investigating the impact of Playworks separately for girls and boys .
METHODS	Twenty-nine schools were randomly assigned to receive Playworks for 1 school year or serve as a control group .
METHODS	Postintervention physical activity data were collected via accelerometers and recess observations .
METHODS	Impacts were estimated separately for girls and boys using regression models .
RESULTS	Girls in Playworks schools had significantly higher accelerometer intensity counts and spent more time in vigorous physical activity than girls in control schools .
RESULTS	No significant differences based on accelerometer data were found for boys .
RESULTS	A significant impact was also found on the types of activities in which girls engaged during recess ; girls in the treatment group were less likely than those in the control group to be sedentary and more likely to engage in jumping , tag , and playground games .
CONCLUSIONS	The current findings suggest that Playworks had a significant impact on some measures of girls ' physical activity , but no significant impact on measures of boys ' physical activity .

###24849445
OBJECTIVE	To compare the effects of 15 % hypertonic saline and 20 % mannitol in doses of similar osmotic burden for treatment of intracranial hypertension in patients with severe traumatic brain injury .
METHODS	We used an alternating treatment protocol to compare the effects of hypertonic saline with that of mannitol given for episodes of increased intracranial pressure ( ICP ) in patients with severe brain injury .
METHODS	Standard guidelines for the management of severe traumatic brain injury were followed .
METHODS	For episodes of increased ICP , 20 % mannitol ( 2 ml/kg , infused for over 20 min ) and 15 % saline ( 0.42 ml/kg , administered as a bolus via a central venous catheter ) of similar osmotic burden were given alternately , with the choice of agent for the initial hypertensive event determined on a randomized basis .
METHODS	Reduction of ICP and duration of the action were recorded after each event .
RESULTS	The data were collected from 33 patients with 237 hypertensive events .
RESULTS	The mean decrease in ICP was 8.7 mm Hg at 28.79.3 min after mannitol treatment as compared with 9.3 mm Hg at 23.67.1 min after treatment with hypertonic saline ( P > 0.05 ) .
RESULTS	The mean duration of the effect was 270 min for mannitol and 318 min for hypertonic saline ( P > 0.05 ) .
CONCLUSIONS	Treatment with 15 % hypertonic saline and 20 % mannitol in doses of similar osmotic burden produces similar effects in management of increased ICP in patients with severe traumatic brain injury in terms of the time of action onset , maximum ICP reduction , and duration of action .

###25611803
BACKGROUND	We have previously shown that in patients with asthma a single dose of an inhaled glucocorticosteroid ( ICS ) acutely potentiates inhaled albuterol-induced airway vascular smooth muscle relaxation through a nongenomic action .
BACKGROUND	An effect on airway smooth muscle was not seen , presumably because the patients had normal lung function .
BACKGROUND	The purpose of the present study was to conduct a similar study in patients with asthma with airflow obstruction to determine if an ICS could acutely also potentiate albuterol-induced airway smooth muscle relaxation in them .
METHODS	In 15 adult patients with asthma ( mean SE baseline FEV1 , 62 % 3 % ) , the response to inhaled albuterol ( 180 g ) was assessed by determining the change in FEV1 ( FEV1 ) for airway smooth muscle and in airway blood flow ( Qaw ) for airway vascular smooth muscle measured 15 min after drug inhalation .
METHODS	Using a double-blind design , the patients inhaled a single dose of the ICS mometasone ( 400 g ) or placebo simultaneously with or 30 min before albuterol inhalation .
RESULTS	After simultaneous drug administration , mean FEV1 was 0.20 0.05 L ( 10 % ) after placebo and 0.32 0.04 L ( 19 % ) after mometasone ( P < .05 ) ; mean Qaw was -2 % after placebo and 30 % after mometasone ( P < .005 ) .
RESULTS	When mometasone or placebo was administered 30 min before albuterol , there was a lesser and insignificant difference in FEV1 between the two treatments , whereas the difference in Qaw remained significant .
CONCLUSIONS	This pilot study showed that in adult patients with asthma with airflow obstruction , a single standard dose of an ICS can acutely increase the FEV1 response to a standard dose of inhaled albuterol administered simultaneously .
CONCLUSIONS	The associated potentiation of albuterol-induced vasodilation in the airway was of greater magnitude and retained when the ICS was administered 30 min before albuterol .
CONCLUSIONS	The clinical significance of this observation will have to be established by a study involving a larger patient cohort .
BACKGROUND	ClinicalTrials.gov ; No. : NCT01210170 ; URL : www.clinicaltrials.gov .

###25262788
BACKGROUND	Hidradenitis suppurativa ( HS ) , is a chronic , recurrent dermatosis affecting skin that contains apocrine glands .
BACKGROUND	Photodynamic therapy using aminolaevulinic acid ( ALA ) activated by intense pulsed light ( IPL ) have shown variable success rates , with some adverse effects .
OBJECTIVE	To evaluate the efficacy and safety of methylene blue ( MB ) as a photosensitizer delivered as a niosomal gel for the treatment of HS using IPL .
METHODS	We enrolled 11 patients with HS in the study , which was a randomized split-body study .
METHODS	One side of each patient 's body was treated with niosomal MB ( NMB ) gel and the other side was treated with unloaded ( free ) MB ( FMB ) gel .
METHODS	The affected sites were irradiated using IPL with a 630 nm filter .
METHODS	Patients were followed up at 1 , 3 and 6 months after treatment .
RESULTS	Drug release from the FMB gel was significantly higher ( P > 0.05 ) than from the NMB gel .
RESULTS	Lesions showed 77.3 % and 44.1 % reduction on the NMB and FMB sides , respectively .
RESULTS	A significant reduction in the Hidradenitis Suppurativa Lesion , Area and Severity Index ( HS-LASI ) after treatment was elicited in both groups , with no pain , erythema or hyperpigmentation .
CONCLUSIONS	The combination of MB as a photosensitizer activated with 630 nm IPL as a light source is a successful PDT for HS .
CONCLUSIONS	Delivery of MB in niosomes was more effective for drug penetration to the dermis compared with delivery by FMB gel .
CONCLUSIONS	The 630 nm filter was not only a source of activation of MB but also a means of hair-follicle destruction .

###25230264
OBJECTIVE	The aim of this prospective , randomized study was to compare the clinical results of arthroscopic single-bundle ( SB ) and triple-bundle ( TB ) anterior cruciate ligament ( ACL ) reconstruction .
METHODS	The study included 105 patients who underwent arthroscopic SB ACL and TB ACL reconstruction .
METHODS	Anterior stress radiographs and the maximal manual muscle test using a KT-2000 arthrometer were used to assess anteroposterior stability and rotational stability was investigated using the lateral pivot shift test at the 24th month follow-up .
METHODS	Clinical results were assessed using the International Knee Documentation Committee ( IKDC ) and Orthopdische Arbeitsgruppe Knie ( OAK ) scores preoperatively and at the 24th month follow-up .
METHODS	Postoperative thigh circumference , strength and range of motion ( ROM ) were compared between groups .
RESULTS	Rotational stability was significantly superior in the TB group than in the SB group .
RESULTS	There were no statistically significant differences with regard to residual anteroposterior laxity determined at the 24th month follow-up .
RESULTS	No significant difference in terms of IKDC score , OAK score , thigh circumference , strength and ROM was detected between the two groups .
CONCLUSIONS	Both arthroscopic SB and TB ACL reconstruction resulted in satisfactory subjective outcome and objective stability .
CONCLUSIONS	Rotational stability was significantly superior in the TB group .

###24849943
OBJECTIVE	To assess the effect on mode of delivery of the routine use of labour epidural analgesia ( EA ) compared with analgesia on request .
METHODS	Randomised non-inferiority trial .
METHODS	One university and one non-university teaching hospital in The Netherlands .
METHODS	Women with a singleton pregnancy in cephalic presentation beyond 36 + 0 weeks ' gestation .
METHODS	Participants were randomly allocated to receive either routine EA or analgesia on request .
METHODS	Intention-to-treat ( ITT ) and per-protocol ( PP ) analyses were performed , with confidence intervals ( CI ) calculated for the differences in percentages or means .
METHODS	Rate of operative delivery ( instrumental vaginal or caesarean ) , labour characteristics , and adverse labour and neonatal outcomes .
RESULTS	A total of 488 women were randomly allocated to the routine EA ( n = 233 ) or analgesia on request group ( n = 255 ) .
RESULTS	In the routine EA group , 89.3 % ( 208/233 ) received EA .
RESULTS	According to ITT analysis , 34.8 % ( 81/233 ) women in the routine EA group had an operative delivery , compared with 26.7 % ( 68/255 ) in the analgesia on request group ( difference 8.1 % , 95 % CI -0.1 to 16.3 ) .
RESULTS	The difference in rate of operative deliveries according to the PP analysis was statistically significant ( difference 8.9 % , 95 % CI 0.4 to 17.4 ) .
RESULTS	Inferiority of EA could not be rejected , as in both analyses the upper bound of the confidence interval exceeded the pre-specified inferiority criterion of +10 % .
RESULTS	Women in the routine EA group had more adverse effects , including hypotension ( difference 9.5 % , 95 % CI 4.2 to 14.9 ) , and motor blockade ( difference 6.8 % , 95 % CI 1.1 to 12.5 ) .
CONCLUSIONS	Non-inferiority of routine EA could not be demonstrated in this trial .
CONCLUSIONS	Routine EA use is likely to lead to more operative deliveries and more maternal adverse effects .
CONCLUSIONS	The results of our study do not justify routine use of EA .

###25288615
OBJECTIVE	We investigated the prevalence of various parental pro-drinking practices and its association with parental drinking status .
METHODS	A school-based survey was completed by 2200 students ( mean age 14.8 , SD 2.0 ; boys 51.4 % ) from 4 randomly selected secondary schools in Hong Kong .
METHODS	Students reported whether they had ever experienced each of nine parental pro-drinking practices ( PPDPs ) .
RESULTS	Overall , 67.5 % of students reported at least one PPDP , but the prevalence was much higher if both parents were drinkers ( 89.0 % ) compared with non-drinkers ( 38.8 % ) .
RESULTS	The adjusted odds ratio ( AOR ) ( 95 % CI ) of experiencing at least one PPDP was 6.79 ( 4.98 , 9.26 ) if either parent drank and 15.71 ( 10.50 , 23.50 ) if both drank compared with none ( P for trend < 0.001 ) .
RESULTS	Compared with non-drinking , the AORs ( 95 % CI ) of experiencing at least one PPDP for occasional drinking and frequent drinking were 6.72 ( 5.03 , 8.98 ) and 18.11 ( 9.88 , 33.18 ) in fathers ( P for trend < 0.001 ) , and 7.33 ( 5.15 , 10.44 ) and 5.33 ( 1.98 , 14.45 ) in mothers .
CONCLUSIONS	The prevalence of PPDPs was generally low in non-drinking parents , but increased dramatically with the number of drinking parents and the frequency of paternal drinking .

###24332384
BACKGROUND	Transcranial magnetic stimulation ( TMS ) is a safe and effective treatment for major depression .
BACKGROUND	We describe quality of life ( QOL ) outcomes from acute treatment with TMS , and describe the durability of benefit across 24-weeks .
METHODS	Three hundred and one medication-free patients with pharmacoresistant major depression were randomized to active or sham TMS in a 6-week controlled trial .
METHODS	Nonresponders to the 6-week blinded phase of the study were enrolled in a 6-week open-label study without unblinding the prior treatment assignment .
METHODS	Responders and partial responders to both the blinded ( active or sham treatment ) or open acute treatment phases were tapered off TMS over three weeks , while initiating maintenance antidepressant medication monotherapy .
METHODS	These subjects entered the 24-week study to examine the durability of response to TMS .
METHODS	The Medical Outcomes Study-36 Item Short Form ( SF-36 ) and the Quality of Life Enjoyment and Satisfaction Questionnaire ( Q-LES-Q ) were used to measure overall function and QOL .
METHODS	During the 24-week durability of effect study , QOL assessments were done at study entry and at the end of 24-weeks .
RESULTS	Statistically significant improvement in both functional status and QOL outcomes was observed in patients treated with active TMS compared with sham TMS during the acute phase of the randomized , sham-controlled trial .
RESULTS	Similar benefits were observed in patients who entered the open-label extension study .
RESULTS	These improvements were sustained across the 24-week follow up study .
CONCLUSIONS	Acute treatment with TMS improved functional status and QOL outcomes in patients with major depression .
CONCLUSIONS	This clinical effect was durable in long-term follow up .

###25183687
BACKGROUND	Current guidelines recommend combining long-acting bronchodilators with different modes of action in patients with moderate-to-severe chronic obstructive pulmonary disease ( COPD ) .
BACKGROUND	We evaluated the effects of airway dimensions and pulmonary function with tiotropium plus indacaterol versus Advair ( ) .
METHODS	Subjects ( n = 46 ) were randomized to receive tiotropium ( 18g once daily ) plus indacaterol ( 150g once daily ) or Advair ( ) ( 50/250g twice daily ) for 16 weeks .
METHODS	Airway geometry was determined by quantitative computed tomography ( luminal area , Ai ; total area of the airway , Ao ; wall area , WA ; and percentage wall area , WA/Ao and wall thickness , T ) .
METHODS	Spirometry ( forced expiratory volume in 1s , FEV1 ; forced vital capacity , FVC and inspiratory capacity , IC ) and St. George 's Respiratory Questionnaire ( SGRQ ) were evaluated .
RESULTS	Tiotropium plus indacaterol significantly increased CT-indices including Ai corrected for body surface area ( Ai/BSA ) , and decreased WA/BSA , WA/Ao and T/BSA compared with Advair ( ) ( p < 0.05 , respectively ) .
RESULTS	In physiological parameters , mean difference in IC was significantly higher under treatment with tiotropium plus indacaterol than Advair ( ) ( p < 0.05 ) .
RESULTS	The changes in Ai/BSA , WA/BSA , WA/Ao and T/BSA were significantly correlated with changes in IC ( r = 0.535 , p = 0.011 ; r = -0.688 , p < 0.001 ; r = -0.555 , p = 0.002 and r = -0.542 , p = 0.007 ; respectively ) .
RESULTS	There were more significant improvements in SGRQ scores after treatment with tiotropium plus indacaterol than Advair ( ) .
CONCLUSIONS	These findings suggest that dual bronchodilation with tiotropium plus indacaterol is superior in airway geometry and lung function compared with Advair ( ) in COPD .

###25798990
OBJECTIVE	Little is known about the long-term effect of a chef-enhanced menu on healthier food selection and consumption in school lunchrooms .
OBJECTIVE	In addition , it remains unclear if extended exposure to other strategies to promote healthier foods ( eg , choice architecture ) also improves food selection or consumption .
OBJECTIVE	To evaluate the short - and long-term effects of chef-enhanced meals and extended exposure to choice architecture on healthier school food selection and consumption .
METHODS	A school-based randomized clinical trial was conducted during the 2011-2012 school year among 14 elementary and middle schools in 2 urban , low-income school districts ( intent-to-treat analysis ) .
METHODS	Included in the study were 2638 students in grades 3 through 8 attending participating schools ( 38.4 % of eligible participants ) .
METHODS	Schools were first randomized to receive a professional chef to improve school meal palatability ( chef schools ) or to a delayed intervention ( control group ) .
METHODS	To assess the effect of choice architecture ( smart caf ) , all schools after 3 months were then randomized to the smart caf intervention or to the control group .
METHODS	School food selection was recorded , and consumption was measured using plate waste methods .
RESULTS	After 3 months , vegetable selection increased in chef vs control schools ( odds ratio [ OR ] , 1.75 ; 95 % CI , 1.36-2 .24 ) , but there was no effect on the selection of other components or on meal consumption .
RESULTS	After long-term or extended exposure to the chef or smart caf intervention , fruit selection increased in the chef ( OR , 3.08 ; 95 % CI , 2.23-4 .25 ) , smart caf ( OR , 1.45 ; 95 % CI , 1.13-1 .87 ) , and chef plus smart caf ( OR , 3.10 ; 95 % CI , 2.26-4 .25 ) schools compared with the control schools , and consumption increased in the chef schools ( OR , 0.17 ; 95 % CI , 0.03-0 .30 cups/d ) .
RESULTS	Vegetable selection increased in the chef ( OR , 2.54 ; 95 % CI , 1.83-3 .54 ) , smart caf ( OR , 1.91 ; 95 % CI , 1.46-2 .50 ) , and chef plus smart caf schools ( OR , 7.38 , 95 % CI , 5.26-10 .35 ) compared with the control schools , and consumption also increased in the chef ( OR , 0.16 ; 95 % CI , 0.09-0 .22 cups/d ) and chef plus smart caf ( OR , 0.13 ; 95 % CI , 0.05-0 .19 cups/d ) schools ; however , the smart caf intervention alone had no effect on consumption .
CONCLUSIONS	Schools should consider both collaborating with chefs and using choice architecture to increase fruit and vegetable selection .
CONCLUSIONS	Efforts to improve the taste of school foods through chef-enhanced meals should remain a priority because this was the only method that also increased consumption .
CONCLUSIONS	This was observed only after students were repeatedly exposed to the new foods for 7 months .
CONCLUSIONS	Therefore , schools should not abandon healthier options if they are initially met with resistance .
BACKGROUND	clinicaltrials.gov Identifier : NCT02309840 .

###25118610
BACKGROUND	The aim of the study was to evaluate the impact of magnesium ( Mg ) on the evolution of arterial calcifications in hemodialysis patients .
METHODS	Seventy-two stable hemodialysis patients were randomly allocated to two groups : 36 administered a regimen containing magnesium carbonate plus calcium acetate as a phosphate binder ( Mg group ) , while the rest 36 received calcium acetate alone ( Ca group ) .
METHODS	The presence and the progression of arterial calcifications were evaluated in plain X-rays using a simple vascular calcification score .
METHODS	The duration of the follow-up period was 12 months .
RESULTS	Thirty-two patients of the Mg group and 27 of the Ca group completed the study .
RESULTS	The mean time average values of the biochemical laboratories did not differ between the two groups , except serum Mg : 2.83 + 0.38 in the Mg group versus 2.52 + 0.27 mg/dl in the Ca group , p = 0.001 .
RESULTS	In 9/32 ( 28.12 % ) patients of the Mg group and in 12/27 ( 44.44 % ) patients of the Ca group , the arterial calcifications were worsened , p = 0.276 .
RESULTS	Moreover , in 4/32 ( 15.6 % ) patients of the Mg group and in 0/27 ( 0 % ) patients of the Ca group , they were improved , p = 0.040 .
RESULTS	The multivariate logistic regression analysis revealed that serum magnesium was an independent predictor for no progression of the arterial calcifications , p = 0.047 .
CONCLUSIONS	Magnesium probably retards the arterial calcifications in hemodialysis patients .
CONCLUSIONS	Further clinical studies are needed to clarify whether magnesium provides cardiovascular protection to this group of patients .

###24802283
OBJECTIVE	The aim of this study was to compare the clinical and aesthetic outcomes of two different surgical approaches for the treatment of deep gingival recession affecting the mandibular incisors .
METHODS	Fifty patients with Miller class I and II gingival recessions ( 3 mm ) in the lower incisors were enrolled .
METHODS	Twenty-five patients were randomly assigned to the control group and the other 25 patients to the test group .
METHODS	All defects were treated with the coronally advanced flap + connective tissue graft ( CAF + CTG ) and in the test group the labial submucosal tissue ( LST ) was removed .
METHODS	Post-operative morbidity was evaluated at 1 week .
METHODS	Clinical and aesthetic evaluations were made at 1 year .
RESULTS	Statistically greater recession reduction , probability of CRC ( adjusted OR 7.94 95 % CI = 1.88-33 .50 , p = 0.0024 ) and greater increase in GT were observed in the test group .
RESULTS	Greater graft exposure and increase in KTH were demonstrated in the control group .
RESULTS	Better aesthetics outcomes were observed in the test group .
RESULTS	No statistically significant between groups differences were demonstrated in patient analgesic assumption and post-operative discomfort and bleeding .
CONCLUSIONS	LST removal during CAF + CTG surgery is indicated to provide better root coverage and aesthetic outcomes in the treatment of gingival recessions affecting the lower incisors .

###25425058
OBJECTIVE	The aim of this study was to compare the efficacy and safety of lercanidipine and amlodipine in the treatment of hypertensive patients with acute cerebral ischemic stroke .
METHODS	An open label , controlled , randomized , parallel-group study was conducted on 104 hypertensive patients ( blood pressure [ BP ] > 130/80mmHg ) diagnosed with ischemic stroke .
METHODS	Enrolled subjects were randomly assigned to a 4 week treatment with lercanidipine 20mg/day or amlodipine 10mg/day .
METHODS	The treatment was administered during the acute phase of the stroke , either immediately after the diagnosis or during an observation period of maximum 6 days .
RESULTS	Both lercanidipine and amlodipine were able to significantly reduce mean clinical systolic BP ( SBP ) / diastolic BP ( DBP ) , mean 24h ambulatory BP and day-time and night-time BP .
RESULTS	In particular , mean clinical SBP/DBP was reduced from 168.921.6 / 96.213.6 mmHg to 147.122.0 / 87.114.0 mmHg in the lercanidipine group ( p < 0.001 for SBP and p < 0.01 for DBP ) and from 167.119.9 / 97.814.5 mmHg to 143.321.9 / 82.814.1 mmHg in the amlodipine-treated group ( p < 0.001 for both SBP and DBP ) .
RESULTS	No statistical difference was observed between the two treatments in the reduction of clinical BP .
RESULTS	The response and normalization rates registered in the two groups of patients were also similar , with no significant difference between the two drugs .
RESULTS	In addition , both treatments reported comparable results in terms of early morning BP surge reduction and BP stabilization , measured through trough-peak ratio and smoothness index .
RESULTS	However lercanidipine showed a better tolerability profile than amlodipine , with fewer adverse events and a lower percentage of patients suffering from side effects .
CONCLUSIONS	Lercanidipine is as effective as amlodipine in the reduction and stabilization of BP in hypertensive patients after a stroke , and presents some advantages in terms of safety .
CONCLUSIONS	Larger studies are necessary to further evaluate these preliminary findings .

###24488700
OBJECTIVE	This study was intended to explore the relationship between the genetic polymorphisms of the 8 single nucleotide polymorphisms ( SNPs ) at CYP genes , neuroendocrine factors and the response to selective serotonin reuptake inhibitors ( SSRIs ) in Chinese Han depressive patients .
METHODS	This was a 6-week randomized controlled trial consisting of 290 Chinese Han depressive patients treated with SSRIs .
METHODS	8 SNPs of CYP450 genes and 7 neuroendocrine factors were detected .
METHODS	Allele and genotype frequencies were compared between responders and non-responders .
METHODS	The relationships between neuroendocrine factors and treatment response were also analyzed .
RESULTS	No significant differences were found in clinical features between 2 groups at the baseline .
RESULTS	No statistical correlation was found between either the genotype or allele frequencies of SNPs in CYP1A2 , CYP2C19 , or CYP2D6 gene and the - efficacy of SSRIs .
RESULTS	There were strong linkage disequilibria between rs4986894 , rs1853205 , and rs12767583 of CYP2C19 genes , and rs2472299 , rs2472300 of CYP1A2 genes .
RESULTS	No associations were found between the above haplotypes and the antidepressant response .
RESULTS	No neuroendocrine factor was a significant predictor for a response to SSRI antidepressants independently .
RESULTS	The combination of neuroendocrine factors , however , predicted the response by 76.1 % .
CONCLUSIONS	There were no significant associations between the 6 SNPs of CYP gene polymorphisms and SSRI response .
CONCLUSIONS	Neither cytochrome P450 family genes nor neuroendocrine factors independently predict the patients ' response to the antidepressants separately .
CONCLUSIONS	A combination of neuroendocrine factors , however , does have the potential to predict the response .

###24238651
BACKGROUND	Limited previous findings have detailed biomechanical advantages following implantation with mobile bearing ( MB ) prostheses after total knee replacement ( TKR ) surgery during walking .
BACKGROUND	The aim of this study was to compare three dimensional spatiotemporal , kinematic , and kinetic parameters during walking to examine whether MBs offer functional advantages over fixed bearing ( FB ) designs .
METHODS	Sixteen patients undergoing primary unilateral TKR surgery were randomised to receive either a FB ( n = 8 ) or MB ( n = 8 ) total knee prosthesis .
METHODS	Eight age and gender matched controls underwent the same protocol on one occasion .
METHODS	A 12 camera Vicon system integrated with four force plates was used .
METHODS	Patients were tested pre-surgery and nine months post-surgery .
RESULTS	No significant differences between FB and MB groups were found at any time point in the spatiotemporal parameters .
RESULTS	The MB group was found to have a significantly reduced frontal plane knee range of motion ( ROM ) at pre-surgery than the FB group ( FB = 14.924.02 ; MB = 8.874.82 ) , with the difference not observed post-surgery .
RESULTS	No further significant kinematic or kinetic differences were observed between FB and MB groups .
RESULTS	Fixed bearing and MB groups both displayed spatiotemporal , kinematic , and kinetic differences when compared to controls .
RESULTS	Fixed bearing and MB groups differed from controls in six and five parameters at nine months post-surgery , respectively .
CONCLUSIONS	No functional advantages were found in knees implanted with MB prostheses during walking , with both groups indicative of similar differences when compared to normal knee biomechanics following prosthesis implantation .
METHODS	Level II .

###25982134
BACKGROUND	Hypofibrinogenaemia is one of the main reasons for development of perioperative coagulopathy during major paediatric surgery .
BACKGROUND	The aim of this study was to assess whether prophylactic maintenance of higher fibrinogen concentrations through administration of fibrinogen concentrate would decrease the volume of transfused red blood cell ( RBCs ) .
METHODS	In this prospective , randomised , clinical trial , patients aged 6 months to 17 yr undergoing craniosynostosis and scoliosis surgery received fibrinogen concentrate ( 30 mg kg ( -1 ) ) at two predefined intraoperative fibrinogen concentrations [ ROTEM ( ) FIBTEM maximum clot firmness ( MCF ) of < 8 mm ( conventional ) or < 13 mm ( early substitution ) ] .
METHODS	Total volume of transfused RBCs was recorded over 24 h after start of surgery .
RESULTS	Thirty children who underwent craniosynostosis surgery and 19 children who underwent scoliosis surgery were treated per protocol .
RESULTS	During craniosynostosis surgery , children in the early substitution group received significantly less RBCs ( median , 28 ml kg ( -1 ) ; IQR , 21 to 50 ml kg ( -1 ) ) compared with the conventional fibrinogen trigger of < 8 mm ( median , 56 ml kg ( -1 ) ; IQR , 28 to 62 ml kg ( -1 ) ) ( P = 0.03 ) .
RESULTS	Calculated blood loss as per cent of estimated total blood volume decreased from a median of 160 % ( IQR , 110-190 % ) to a median of 90 % ( IQR , 78-110 % ) ( P = 0.017 ) .
RESULTS	No significant changes were observed in the scoliosis surgery population .
RESULTS	No bleeding events requiring surgical intervention , postoperative transfusions of RBCs , or treatment-related adverse events were observed .
CONCLUSIONS	Intraoperative administration of fibrinogen concentrate using a FIBTEM MCF trigger level of < 13 mm can be successfully used to significantly decrease bleeding , and transfusion requirements in the setting of craniosynostosis surgery , but not scoliosis .
BACKGROUND	ClinicalTrials.gov NCT01487837 .

###24747100
OBJECTIVE	This study sought to determine whether circadian patterns in ventricular arrhythmias ( VAs ) occur in a current primary prevention defibrillator ( implantable cardioverter-defibrillator [ ICD ] ) population .
BACKGROUND	Cardiovascular events , including VAs , demonstrate biorhythmic periodicity .
METHODS	We tested for deviation from the previously described occurrences of a morning peak , early morning nadir , and peak on Mondays in ICD therapies using generalized estimating equations and Student t tests .
METHODS	All hypothesis tests were performed in the entire cohort of patients with VAs as well as pre-specified subgroups .
RESULTS	Of 811 patients with an ICD , 186 subjects experienced 714 ICD therapy episodes for life-threatening VA. .
RESULTS	There was no morning ( 6 am to 12 pm ) peak in therapies for the entire cohort or any subgroups .
RESULTS	The overall cohort and several subgroups had a typical early morning ( 12 am to 6 am ) nadir in therapies , with significantly less than 25 % of therapies occurring during this 6-h block ( all p < 0.05 ) .
RESULTS	A significant peak in therapies on Mondays occurred only in patients not on beta-blocker therapy ( 22 % of events for the week , p = 0.029 ) .
CONCLUSIONS	In the SCD-HeFT ( Sudden Cardiac Death in Heart Failure Trial ) population , the distribution of life-threatening VA failed to show a typical early morning peak or increased VA events on Mondays .
CONCLUSIONS	A typical early morning nadir was seen in the entire cohort .
CONCLUSIONS	An increased rate of events on Mondays was found in the subgroup of subjects not on beta-blocker therapy .
CONCLUSIONS	These findings may indicate suppression of the neurohormonal triggers for VA by current heart failure therapy , particularly the use of beta-blockers in heart failure .

###25218533
OBJECTIVE	The study objective was to identify the predictors of outcomes in a contemporary cohort of patients from the Reduction in cardiovascular Events by acaDesine in patients undergoing CABG ( RED-CABG ) trial .
OBJECTIVE	Despite the increasing risk profile of patients who undergo coronary artery bypass grafting , morbidity and mortality have remained low , and identification of the current predictors of adverse outcomes may permit new treatments to further improve outcomes .
METHODS	The RED-CABG trial was a multicenter , randomized , double-blind , placebo-controlled study that determined that acadesine did not reduce adverse events in moderately high-risk patients undergoing nonemergency coronary artery bypass grafting .
METHODS	The primary efficacy end point was a composite of all-cause death , nonfatal stroke , or the need for mechanical support for severe left ventricular dysfunction through postoperative day 28 .
METHODS	Logistic regression modeling with stepwise variable selection identified which prespecified baseline characteristics were associated with the primary outcome .
METHODS	A second logistic model included intraoperative variables as potential covariates .
RESULTS	The 4 independent preoperative risk factors predictive of the composite end point were ( 1 ) a history of heart failure ( odds ratio , 2.9 ) ; ( 2 ) increasing age ( odds ratio , 1.033 per decade ) ; ( 3 ) a history of peripheral vascular disease ( odds ratio , 1.6 ) ; and ( 4 ) receiving aspirin before coronary artery bypass grafting ( odds ratio , 0.5 ) , which was protective .
RESULTS	The duration of the cardiopulmonary bypass ( odds ratio , 1.8 ) was the only intraoperative variable that contributed to adverse outcomes .
CONCLUSIONS	Patients who had heart failure and preserved systolic function had a similar high risk of adverse outcomes as those with low ejection fractions , and new approaches may mitigate this risk .
CONCLUSIONS	Recognition of patients with excessive atherosclerotic burden may permit perioperative interventions to improve their outcomes .
CONCLUSIONS	The contemporary risks of coronary artery bypass grafting have changed , and their identification may permit new methods to improve outcomes .

###25774705
BACKGROUND	Treatments for childhood obesity are critically needed because of the risk of developing co-morbidities , although the interventions are frequently time-consuming , frustrating , difficult , and expensive .
METHODS	We conducted a longitudinal , randomised , clinical study , based on a per protocol analysis , on 133 obese children and adolescents ( n = 69 males and 64 females ; median age , 11.3 years ) with family history of obesity and type 2 diabetes mellitus ( T2DM ) .
METHODS	The patients were divided into three arms : Arm A ( n = 53 patients ) , Arm B ( n = 45 patients ) , and Arm C ( n = 35 patients ) patients were treated with a low-glycaemic-index ( LGI ) diet and Policaptil Gel Retard , only a LGI diet , or only an energy-restricted diet ( ERD ) , respectively .
METHODS	The homeostasis model assessment of insulin resistance ( HOMA-IR ) and the Matsuda , insulinogenic and disposition indexes were calculated at T0 and after 1 year ( T1 ) .
RESULTS	At T1 , the BMI-SD scores were significantly reduced from 2.32 to 1.80 ( p < 0.0001 ) in Arm A and from 2.23 to 1.99 ( p < 0.05 ) in Arm B. Acanthosis nigricans was significantly reduced in Arm A ( 13.2 % to 5.6 % ; p < 0.05 ) , and glycosylated-haemoglobin levels were significantly reduced in Arms A ( p < 0.005 ) .
RESULTS	The percentage of glucose-metabolism abnormalities was reduced , although not significantly .
RESULTS	However , the HOMA-IR index was significantly reduced in Arms A ( p < 0.0001 ) and B ( p < 0.05 ) , with Arm A showing a significant reduction in the insulinogenic index ( p < 0.05 ) .
RESULTS	Finally , the disposition index was significantly improved in Arms A ( p < 0.0001 ) and B ( p < 0.05 ) .
CONCLUSIONS	A LGI diet , particularly associated with the use of Policaptil Gel Retard , may reduce weight gain and ameliorate the metabolic syndrome and insulin-resistance parameters in obese children and adolescents with family history of obesity and T2DM .

###25060370
BACKGROUND	The degree of antiplatelet response to clopidogrel has been associated with clinical outcomes .
BACKGROUND	Studies have investigated whether adjustment of antiplatelet therapies based on a single platelet function test is beneficial .
OBJECTIVE	The aim of the study was to test the stability of platelet reactivity measurements over time among patients treated with standard and double doses of clopidogrel .
METHODS	The ELEVATE-TIMI 56 ( Escalating Clopidogrel by Involving a Genetic Strategy-Thrombolysis In Myocardial Infarction 56 ) investigators genotyped 333 patients with coronary artery disease and randomized them to various clopidogrel regimens .
METHODS	Patients with at least 2 platelet function results on the same maintenance dose of clopidogrel ( 75 mg or 150 mg ) were analyzed .
METHODS	Platelet aggregation was measured using P2Y12 reaction units ( PRU ) .
RESULTS	In total , the mean platelet reactivity and the total number of nonresponders ( PRU 230 ) with clopidogrel did not change between 2 periods for the 75-mg ( 22.4 % vs. 21.9 % ; p = 0.86 ) and 150-mg doses of clopidogrel ( 11.5 % vs. 11.5 % ; p = 1.00 ) .
RESULTS	In contrast , when evaluating each patient individually , 15.7 % of patients taking clopidogrel 75 mg and 11.4 % of patients taking 150 mg had a change in their responder status when tested at 2 different time points ( p < 0.001 ) .
RESULTS	Despite being treated with the same dose of clopidogrel , > 40 % of patients had a change in PRU > 40 on serial sampling , which approximates the average PRU difference caused by increasing the clopidogrel dose from 75 mg to 150 mg .
CONCLUSIONS	Measurements of platelet reactivity vary over time in a significant proportion of patients .
CONCLUSIONS	Thus , treatment adjustment according to platelet function testing at a single time point might not be sufficient for guiding antiplatelet therapy in clinical or research settings .
CONCLUSIONS	( Escalating Clopidogrel by Involving a Genetic Strategy-Thrombolysis In Myocardial Infarction 56 [ ELEVATE-TIMI 56 ] ; NCT01235351 ) .

###26098966
BACKGROUND	To date , studies assessing the risk of post-transplant hepatocellular carcinoma ( HCC ) recurrence have focused on tumour characteristics .
BACKGROUND	This study investigated the impact of donor characteristics and graft quality on post-transplant HCC recurrence .
METHODS	Using the Scientific Registry of Transplant Recipients patients with HCC who received a liver transplant between 2004 and 2011 were included , and post-transplant HCC recurrence was assessed .
METHODS	A multivariable competing risk regression model was fitted , adjusting for confounders such as recipient sex , age , tumour volume , - fetoprotein , time on the waiting list and transplant centre .
RESULTS	A total of 9724 liver transplant recipients were included .
RESULTS	Patients receiving a graft procured from a donor older than 60 years ( adjusted hazard ratio ( HR ) 1.38 , 95 per cent c.i. 1.10 to 1.73 ; P = 0.006 ) , a donor with a history of diabetes ( adjusted HR 1.43 , 1.11 to 1.83 ; P = 0.006 ) and a donor with a body mass index of 35 kg/m ( 2 ) or more ( adjusted HR 1.36 , 1.04 to 1.77 ; P = 0.023 ) had an increased rate of post-transplant HCC recurrence .
RESULTS	In 3007 patients with documented steatosis , severe graft steatosis ( more than 60 per cent ) was also linked to an increased risk of recurrence ( adjusted HR 1.65 , 1.03 to 2.64 ; P = 0.037 ) .
RESULTS	Recipients of organs from donation after cardiac death donors with prolonged warm ischaemia had higher recurrence rates ( adjusted HR 4.26 , 1.20 to 15.1 ; P = 0.025 ) .
CONCLUSIONS	Donor-related factors such as donor age , body mass index , diabetes and steatosis are associated with an increased rate of HCC recurrence after liver transplantation .

###25033743
BACKGROUND	Considering that adolescent mothers may be more vulnerable to discontinuing exclusive breastfeeding ( EBF ) before 6months and that their mothers may exert a negative influence on this practice , this study was conducted with the objective of evaluating the efficacy of breastfeeding counselling for adolescent mothers and their mothers in increasing EBF duration .
METHODS	A clinical trial was performed in 323 adolescent mothers with newborns and their mothers randomized in four groups : ( 1 ) not living with mother , without intervention ; ( 2 ) not living with mother , with intervention ; ( 3 ) living with mother , without intervention , ( 4 ) living with mother , with intervention .
METHODS	The intervention consisted of five counselling sessions directed to mother and grandmother , in the maternity hospital and on follow-up .
METHODS	Information about feeding practices during the newborn 's first six months of life was collected monthly by telephone .
METHODS	Intervention 's efficacy was measured through Cox regression and comparison of exclusive breastfeeding medians and survival curves for the different groups .
RESULTS	The intervention increased the duration of EBF by67 days for the group which included grandmothers ( HR = 0.64 ; CI 95 % = 0.46-0 .90 ) and 46days for the group which did not include grandmothers ( HR = 0.52 ; CI 95 % = 0.36-0 .76 ) .
CONCLUSIONS	Counselling sessions in the first four months of children 's lives proved to be effective in increasing EBF duration among adolescent mothers .
BACKGROUND	ClinicalTrials.gov NCT00910377 .

###25434635
BACKGROUND	Analysis of progression-free survival ( PFS ) as the primary endpoint in advanced epithelial ovarian , fallopian tube , and primary peritoneal cancer ( AEOC ) trials may be confounded by the difficulty of radiologic evaluation of disease progression and the potential for discrepancy between investigator and blinded independent central assessments .
BACKGROUND	PFS as assessed by local investigator ( INV ) was the primary endpoint of AGO-OVAR16 , a randomized , double-blind trial of pazopanib maintenance therapy in AEOC .
BACKGROUND	To confirm the robustness of the primary analysis , PFS was also evaluated by blinded independent central review ( BICR ) .
METHODS	Patients with histologically confirmed AEOC ( N = 940 ) were randomized 1:1 to receive pazopanib 800 mg/day or placebo for up to 24 months .
METHODS	Tumor response in the intent-to-treat population was evaluated by CT/MRI every 6 months and analyzed per RECIST 1.0 .
RESULTS	Pazopanib prolonged PFS versus placebo by INV ( median 17.9 vs 12.3 months ; hazard ratio [ HR ] = 0.766 , 95 % confidence interval [ CI ] : 0.643-0 .911 ; P = 0.0021 ) .
RESULTS	Results for PFS by BICR were similar ( median 15.4 vs 11.8 months ; HR = 0.802 , 95 % CI : 0.678-0 .949 ; P = 0.0084 ) .
RESULTS	Progression events were recorded later by INV in 23 % of pazopanib-treated patients and 17 % of placebo-treated patients .
RESULTS	The overall concordance between INV and BICR assessments was 84 % and 86 % in the pazopanib and placebo arms , respectively .
CONCLUSIONS	By INV and BICR assessments , maintenance therapy with pazopanib in AEOC provided a significantly longer PFS than placebo .
CONCLUSIONS	The good overall concordance between INV and BICR assessments , as well as HR and P value consistency , supports the reliability of investigator-assessed PFS as the primary endpoint in AGO-OVAR16 .

###24344941
OBJECTIVE	The aim of this study was to evaluate the effectiveness of sitagliptin , alone or in combination with metformin , in kidney transplant patients with newly diagnosed new-onset diabetes mellitus after transplant who had inadequate glycemic control , compared with a group of patients receiving insulin glargine with special emphasis on weight gain .
METHODS	Newly diagnosed renal transplant patients with new-onset diabetes mellitus after a transplant was defined by a blood glucose 11.1 mmol/L after an oral glucose tolerance test were examined .
METHODS	They were treated with standard immunosuppression composed of triple therapy with tacrolimus or cyclosporine , mycophenolate mofetil or azathioprine , and prednisone .
METHODS	They had stable graft function for more than 6 months after the transplant .
RESULTS	Patients with new-onset diabetes mellitus after transplant ( n = 28 ) whose glycemia was not controlled adequately with oral hypoglycemic agents ( either alone or in combination ) received oral sitagliptin 100 mg once daily in addition to existing therapy for 12 weeks .
RESULTS	Patients who received insulin glargine as add-on therapy ( n = 17 ) served as the control group .
RESULTS	Data analyses included glycated hemoglobin , fasting plasma glucose , lipid profile , body weight , and the occurrence of hypoglycemia .
RESULTS	We found significant reductions in glycated hemoglobin and fasting plasma glucose values after 12 weeks of additional sitagliptin therapy that were comparable to those with insulin glargine .
RESULTS	While the addition of stagliptin resulted in a small weight loss ( 0.4 kg ) , the addition of insulin glargine resulted in a weight gain ( 0.8 kg ) .
RESULTS	The overall incidence of adverse experiences was low and generally mild in both groups .
CONCLUSIONS	In a group of renal transplant recipients with new-onset diabetes mellitus after a transplant in whom glycemia was not controlled adequately by oral hypoglycemic agents , the addition of sitagliptin helped to achieve glycemic control similar to insulin glargine but with a marginal weight advantage .

###25074252
BACKGROUND	Microvascular obstruction seems to predict poor outcome in patients undergoing elective percutaneous coronary intervention ( PCI ) , but the underlying mechanism is still unclear .
BACKGROUND	We analyzed whether serum thromboxane B2 , a stable metabolite of thromboxane A2 , may be implicated in post-PCI microvascular obstruction .
RESULTS	We enrolled 91 patients ( 74 males , 6610 years ) on chronic low-dose aspirin therapy ( aspirin , 100 mg daily ) scheduled for elective PCI and randomly assigned to receive aspirin reload ( 325 mg orally , n = 46 ) or no reload ( control group , n = 45 ) 1 hour before elective PCI .
RESULTS	Serum levels of thromboxane B2 , reperfusion indexes ( corrected Thrombolysis In Myocardial Infarction frame count and myocardial blush grade ) , and serum cardiac troponin I were assessed before and after PCI .
RESULTS	Serum thromboxane B2 significantly increased after 120 minutes ( P = 0.0447 ) from PCI in control but not in aspirin reload group .
RESULTS	After PCI , both groups showed a statistically significant reduction in corrected Thrombolysis In Myocardial Infarction frame count more evident in aspirin reload group ( P = 0.0023 ) .
RESULTS	Moreover , after PCI , 61 % of patients allocated to aspirin reload and only 32 % of patients allocated to control group reached normal microcirculatory reperfusion ( myocardial blush grade = 3 ) ; patients with myocardial blush grade = 3 exhibited lower values of serum thromboxane B2 compared with those with myocardial blush grade < 3 ( P = 0.05 ) .
RESULTS	Periprocedural cardiac troponin I significantly increased ( F = 3.64 ; P = 0.01334 ) and correlated with serum thromboxane B2 ( = 0.31 ; P = 0.0413 ) in control but not in aspirin reload group .
RESULTS	In addition , left ventricular ejection fraction significantly increased after PCI only in the aspirin reload group ( P = 0.0005 ) .
CONCLUSIONS	Aspirin loading dose before elective PCI improves myocardial reperfusion and injury indexes , suggesting a possible role of platelet thromboxane A2 in microvascular occlusion .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01374698 .

###24480836
OBJECTIVE	To study the analgesic effect of electroacupuncture ( EA ) as perioperative adjunctive therapy added to a systemic analgesic strategy ( including tramadol and ketamine ) for postoperative pain , opioid-related side effects and patient satisfaction .
METHODS	In a sham-controlled participant - and observer-blinded trial , 75 patients undergoing radical prostatectomy were randomly assigned to two groups : ( 1 ) EA ( n = 37 ; tramadol + ketamine + EA ) and ( 2 ) control ( n = 38 ; tramadol + ketamine ) .
METHODS	EA ( 100Hz frequency ) was applied at LI4 bilaterally during the closure of the abdominal walls and EA ( 4Hz ) was applied at ST36 and LI4 bilaterally immediately after extubation .
METHODS	The control group had sham acupuncture without penetration or stimulation .
METHODS	The following outcomes were evaluated : postoperative pain using the Numerical Rating Scale ( NRS ) and McGill Scale ( SF_MPQ ) , mechanical pain thresholds using algometer application close to the wound , cortisol measurements , rescue analgesia , Spielberger State Trait Anxiety Inventory ( STAI Y-6 item ) , patient satisfaction and opioid side effects .
RESULTS	Pain scores on the NRS and SF_MPQ were significantly lower and electronic pressure algometer measurements were significantly higher in the EA group than in the control group ( p < 0.001 ) at all assessments .
RESULTS	In the EA group a significant decrease in rescue analgesia was observed at 45min ( p < 0.001 ) and a significant decrease in cortisol levels was also observed ( p < 0.05 ) .
RESULTS	Patients expressed satisfaction with the analgesia , especially in the EA group ( p < 0.01 ) .
RESULTS	Significant delays in the start of bowel movements were observed in the control group at 45min ( p < 0.001 ) and 2h ( p < 0.05 ) .
CONCLUSIONS	Adding EA perioperatively should be considered an option as part of a multimodal analgesic strategy .

###25447626
BACKGROUND	Contemporary studies suggest an association between venous thromboembolism and a higher incidence of major cardiovascular events , mostly attributed to arterial atherothrombosis .
BACKGROUND	Using data from the Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research ( NAVIGATOR ) trial , we assessed the association of venous thromboembolism with major cardiovascular events .
METHODS	In NAVIGATOR , patients with impaired glucose tolerance were randomly allocated to receive valsartan or placebo and nateglinide or placebo in addition to lifestyle modification .
METHODS	Baseline characteristics and prior history of venous thromboembolism were assessed .
METHODS	After adjusting for important baseline covariates , Cox proportional hazards regression models were used to assess the association between venous thromboembolism and major cardiovascular outcomes .
RESULTS	Of the 9306 patients enrolled , 129 ( 1.4 % ) had a history of venous thromboembolism .
RESULTS	Patients with venous thromboembolism were older , more frequently white and female , and had a higher body mass index .
RESULTS	Patients with venous thromboembolism had higher 5-year event rates for the composite of death , myocardial infarction , and stroke , as compared with patients without venous thromboembolism ( 10.7 % vs 5.9 % ; P < .001 ; adjusted hazard ratio 2.12 ; 95 % confidence interval , 1.36-3 .31 ; P = .001 ) .
CONCLUSIONS	In patients with impaired glucose tolerance at high risk for cardiovascular events , the prevalence of venous thromboembolism was rare but associated with worse long-term cardiovascular outcomes , including arterial events .
CONCLUSIONS	Venous thromboembolism is a marker of risk , and attention should be paid to this high-risk group of patients .

###24568299
BACKGROUND	Chronic low back pain causes substantial morbidity and cost to society while disproportionately impacting low-income and minority adults .
BACKGROUND	Several randomized controlled trials show yoga is an effective treatment .
BACKGROUND	However , the comparative effectiveness of yoga and physical therapy , a common mainstream treatment for chronic low back pain , is unknown .
METHODS	This is a randomized controlled trial for 320 predominantly low-income minority adults with chronic low back pain , comparing yoga , physical therapy , and education .
METHODS	Inclusion criteria are adults 18-64 years old with non-specific low back pain lasting 12 weeks and a self-reported average pain intensity of 4 on a 0-10 scale .
METHODS	Recruitment takes place at Boston Medical Center , an urban academic safety-net hospital and seven federally qualified community health centers located in diverse neighborhoods .
METHODS	The 52-week study has an initial 12-week Treatment Phase where participants are randomized in a 2:2:1 ratio into i ) a standardized weekly hatha yoga class supplemented by home practice ; ii ) a standardized evidence-based exercise therapy protocol adapted from the Treatment Based Classification method , individually delivered by a physical therapist and supplemented by home practice ; and iii ) education delivered through a self-care book .
METHODS	Co-primary outcome measures are 12-week pain intensity measured on an 11-point numerical rating scale and back-specific function measured using the modified Roland Morris Disability Questionnaire .
METHODS	In the subsequent 40-week Maintenance Phase , yoga participants are re-randomized in a 1:1 ratio to either structured maintenance yoga classes or home practice only .
METHODS	Physical therapy participants are similarly re-randomized to either five booster sessions or home practice only .
METHODS	Education participants continue to follow recommendations of educational materials .
METHODS	We will also assess cost effectiveness from the perspectives of the individual , insurers , and society using claims databases , electronic medical records , self-report cost data , and study records .
METHODS	Qualitative data from interviews will add subjective detail to complement quantitative data .
BACKGROUND	This trial is registered in ClinicalTrials.gov , with the ID number : NCT01343927 .

###24566755
OBJECTIVE	The objective of this study was to compare cervicovaginal fetal fibronectin ( FFN ) versus transvaginal sonographic cervical length as predictors of preterm birth in twin pregnancy and to test whether 17-hydroxyprogesterone caproate ( 17OHPc ) modifies the predictive value of FFN .
METHODS	Secondary analysis of a randomized trial of 17OHPc versus placebo in dichorionic-diamniotic twins , analyzing the subset with screening FFN ( N = 198 ) and/or cervical length ( N = 214 ) at 24 to 26 weeks of gestation .
RESULTS	Positive FFN was found in 7 % , cervical length 25 mm in 8 % , and both positive FFN and cervical length 25 mm in 3 % .
RESULTS	Birth < 32 , < 34 , and < 37 weeks occurred in 8 , 30 , and 67 % , respectively .
RESULTS	In logistic regression analysis controlling for FFN , cervical length , prior preterm birth , and treatment group , positive FFN was significantly associated with birth < 30 and < 32 weeks ( odds ratio 55.0 [ 95 % confidence interval 5.2-582 ] , 18.1 [ 3.3-99 ] , respectively , p < 0.001 for both ) but cervical length 25 mm was not ( odds ratio 0.1 [ 0.002-1 .6 ] , 0.6 [ 0.1-4 .3 ] ) .
CONCLUSIONS	Positive FFN was stronger than cervical length 25 mm in predicting early preterm birth in twins , regardless of 17OHPc use .
CONCLUSIONS	Treatment with 17OHPc did not appear to alter the predictive value of FFN .

###25306517
OBJECTIVE	The purpose of this study was to compare the clinical outcomes of immediate rotator cuff repair with capsular release and those of rotator cuff repair after the stiffness was treated with rehabilitative therapy .
METHODS	Between June 2007 and December 2010 , we recruited 63 patients with rotator cuff tears and stiffness .
METHODS	In 33 patients arthroscopic rotator cuff repair was performed with capsular release simultaneously ( group I ) .
METHODS	In 30 patients arthroscopic rotator cuff repair was performed after 6 months of preoperative rehabilitation for stiffness ( group II ) .
METHODS	The American Shoulder and Elbow Surgeons score , Simple Shoulder Test score , Constant score , and visual analog scale score for pain and range of motion ( ROM ) were assessed at the start of the study ; at 3 , 6 , and 12 months ; and at the last visit .
METHODS	The postoperative cuff tendon integrity was assessed between 6 and 12 months using magnetic resonance or ultrasound images .
RESULTS	There were no significant differences in preoperative demographic data between the groups ( P > .05 ) .
RESULTS	The mean follow-up period was 21.54 months .
RESULTS	After treatment , there was significant improvement in ROM and functional scores in both groups , as measured at the last follow-up ( P < .05 ) .
RESULTS	No statistical differences were found in clinical scores and ROM at the last follow-up ( P > .05 ) .
RESULTS	On assessment of the magnetic resonance or ultrasound images taken 6 to 12 months postoperatively , the retear rate for the repaired cuff tendon in each group was 12.1 % in group I and 13.4 % in group II .
CONCLUSIONS	In the treatment of rotator cuff tears with stiffness , satisfactory results can be achieved either by repairing the tear with simultaneous capsular release or by waiting to perform the repair after preoperative rehabilitation for stiffness .
CONCLUSIONS	Because a delayed rotator cuff repair after improving ROM offered no clear advantage over an immediate operation , we recommend surgically treating rotator cuff tears with concomitant stiffness early using a simultaneous capsular release method to save time and to avoid unnecessary rehabilitation .
METHODS	Level II , prospective comparative study .

###24352352
BACKGROUND	Antiretroviral ( ARV ) medications differentially penetrate across the blood-brain barrier into central nervous system ( CNS ) tissues , potentially influencing their effectiveness in treating brain infection .
METHODS	This randomized controlled clinical trial ( RCT ) called for 120 participants at 5 study sites to be randomized 1:1 to CNS-targeted ( CNS-T ) or non-CNS-T ART .
METHODS	Entry clinical factors such as ARV experience were balanced across arms using an adaptive randomization approach .
METHODS	The primary outcome , change in neurocognitive performance , was measured as the difference in global deficit score ( GDS ) from baseline to week 16 .
RESULTS	The study was terminated early on the recommendation of its data safety monitoring board on the basis of slow accrual and a low likelihood of detecting a difference in the primary outcome .
RESULTS	No safety concerns were identified .
RESULTS	Of 326 participants screened , 59 met entry criteria and were randomized .
RESULTS	The primary intent-to-treat analysis included 49 participants who completed week 16 .
RESULTS	These comprised 39 men and 10 women with a mean age of 44 years ( SD , 10 years ) , and median nadir and current CD4 ( + ) T-cell counts of 175 cells/L and 242 cells/L , respectively .
RESULTS	The proportional improvement in GDS from baseline was nonsignificantly larger ( 7 % ; 95 % confidence interval [ CI ] , -31 % to 62 % ) in the CNS-T arm than in the non-CNS-T arm , representing a treatment effect size of 0.09 ( 95 % CI , -.48 to .65 ) .
RESULTS	Prespecified secondary analysis showed a trend interaction ( P = .087 ) , indicating that participants who had baseline plasma virologic suppression may have benefited from CNS-T .
CONCLUSIONS	This study found no evidence of neurocognitive benefit for a CNS-T strategy in HIV-associated neurocognitive disorders .
CONCLUSIONS	A benefit for a subgroup or small overall benefits could not be excluded .
CONCLUSIONS	Clinical Trials Registration NCT00624195 .

###24411205
BACKGROUND	This study aimed to examine whether long working hours and short sleep duration were associated with an increased risk of acute myocardial infarction ( AMI ) or severe coronary heart diseases ( SCHD ) , independent of established psychosocial work-related factors .
METHODS	A case-control study was conducted .
METHODS	Cases were 322 men , aged < 60 years and economically active , who were admitted to hospital with a first diagnosed AMI or SCHD during 2008-2011 , of whom 134 were confirmed AMI and the other 188 were angiography-confirmed SCHD .
METHODS	Controls were 644 men who were drawn from a national survey and were matched to the cases on age , education and area of residence .
METHODS	Odds ratios of total CHD and confirmed AMI in relation to average weekly working hours and daily hours of sleep were calculated .
RESULTS	Men with average working hours longer than 60 h/week were found to have significantly increased risks for total CHD ( OR = 2.2 ) as compared to those with weekly working hours in 40-48 h , and those with daily hours of sleep fewer than 6 h were found to have increased risks for CHD ( OR = 3.0 ) as compared to those with sleeping hours in 6-9 h. Restriction to confirmed AMI yielded a greater risk and these associations remained consistent with adjustment of smoking status , body mass index and psychosocial work factors including job demands , job control , workplace justice , job insecurity and shift work .
CONCLUSIONS	The results support the hypothesis that long working hours and short sleep duration contribute independently to the risk of cardiovascular diseases in men .

###25504861
OBJECTIVE	To investigate the impact of tocilizumab treatment on growth and growth-related laboratory parameters in patients with systemic juvenile idiopathic arthritis ( JIA ) enrolled in a phase III clinical trial .
METHODS	Patients with systemic JIA ages 2-17 years ( n = 112 ) received tocilizumab in a 12-week , randomized , placebo-controlled period and a long-term open-label extension .
METHODS	Height velocity and standard deviation ( SD ) score ; levels of insulin-like growth factor 1 ( IGF-1 ) , osteocalcin ( OC ) , and C-telopeptide of type I collagen ( CTX-I ) ; and Juvenile Arthritis Disease Activity Score in 71 joints ( JADAS-71 ) were measured in a post hoc analysis of 83 patients who never received growth hormone and did not reach Tanner stage 5 by the end of the first year of treatment .
RESULTS	Patients had stunted growth at baseline ( mean height SD score -2.2 ) .
RESULTS	During tocilizumab treatment , males ( 73 % ) and females ( 83 % ) experienced above-normal mean height velocities of 6.6 cm/year ( P < 0.0001 versus World Health Organization norms ) .
RESULTS	Mean height SD score increases during year 1 ( 0.29 ) and year 2 ( 0.31 ) were significant ( both P < 0.0001 ) .
RESULTS	The mean SD score for IGF-1 levels increased significantly ( -0.2 for year 1 and -0.1 for year 2 versus -1.0 at baseline ; both P < 0.0001 ) .
RESULTS	Mean OC and CTX-I levels ( both P < 0.0001 ) and the OC : CTX-I ratio ( P = 0.014 ) significantly increased from baseline to year 2 .
RESULTS	In multiple regression analysis , first-year height velocity had a significant inverse relationship to JADAS-71 at year 1 , age , mean glucocorticoid dosage during the year , and height SD score at baseline .
CONCLUSIONS	Our findings indicate that during treatment with tocilizumab , patients with systemic JIA experience significant catch-up growth , normalization of IGF-1 levels , and bone balance improvement favoring bone formation .

###25423698
BACKGROUND	It is widely supported that multicentric disease of the breast ( MCDB ) is a contraindication of breast conservative surgery ( BCS ) .
METHODS	This is a multicentric study ( two breast cancer units from Greece , one from France ) involving patients with at least two primary tumors in separate quadrants of the breast and no diffuse suspicious microcalcifications on mammography .
METHODS	Sixty-one patients were included in the study , but 49 were followed up to the end .
METHODS	Patients were randomly assigned in total mastectomy ( TM ) and BCS groups .
METHODS	End point of the study was disease-free survival rates three and five years after initial operation .
RESULTS	Three years after BCS , local recurrence ( LR ) was observed in two patients ( 7 % ) and one after five years ( total recurrence rate : 11 % ) .
RESULTS	A TM was performed in these patients , and in two there was no LR or distant metastasis ( DM ) five years after .
RESULTS	The third patient was disease free two-years later .
RESULTS	Three years after TM , eight patients ( 36.4 % ) had DM and 14 ( 63.6 % ) did not ( p = 0.004 ) .
RESULTS	Five years after TM , eight patients ( 36.4 % ) had DM and 14 patients ( 63.6 % ) di not ( p = 0.03 ) .
CONCLUSIONS	The results showed that conservative surgery was an alternative surgical option in multicentric breast cancer with good results regarding disease-free survival and recurrence .

###25326163
BACKGROUND	As lithium treatment might be effective in reducing the risk of deliberate self-harm ( DSH ) in adult patients with unipolar affective disorders , we designed a pragmatic randomised trial to assess its efficacy in more than 200 patients with treatment-resistant depression .
BACKGROUND	However , we randomised 56 patients only .
BACKGROUND	The aim of this report is therefore twofold : first , to disseminate the results of this underpowered study which may be incorporated into future meta-analytical reviews ; second , to analyse some critical aspects of the study which might explain failure to reach the target sample size .
METHODS	We carried out a randomised , parallel group , assessor-blinded superiority clinical trial .
METHODS	Adults with a diagnosis of major depression , an episode of DSH in the previous 12 months and inadequate response to at least two antidepressants given sequentially at an adequate dose for an adequate time for the current depressive episode were allocated to add lithium to usual care ( intervention arm ) versus usual care alone ( control arm ) .
METHODS	Suicide completion and acts of DSH during the 12 months of follow-up constituted the composite primary outcome .
RESULTS	Of 58 patients screened for inclusion , 29 were allocated to lithium plus usual care and 27 were assigned to usual care without lithium .
RESULTS	Six patients in the lithium plus usual care group and seven in the usual care group committed acts of DSH during the follow-up phase .
RESULTS	The survival probability did not differ between the two treatment arms ( Chi2 = 0.17 , p = 0.676 ) .
RESULTS	With regard to changes in the severity of depressive symptomatology from baseline to endpoint , no significant differences were detected .
CONCLUSIONS	The present study failed to achieve the minimum sample size needed to detect a clinically meaningful difference between the two treatment arms .
CONCLUSIONS	Consequently , the finding that lithium , in addition to usual care , did not exert a positive effect in terms of reduction of DSH after 12 months of follow-up is likely due to the lack of sufficient statistical power to detect a difference , if a difference existed .
CONCLUSIONS	The dissemination of the results of this underpowered study will inform future meta-analytical reviews on lithium and suicide-related outcomes .
BACKGROUND	ClinicalTrials.gov identifier : NCT00927550 .

###24430319
OBJECTIVE	Intensive follow-up after surgery for colorectal cancer is common practice but is based on limited evidence .
OBJECTIVE	To assess the effect of scheduled blood measurement of carcinoembryonic antigen ( CEA ) and computed tomography ( CT ) as follow-up to detect recurrent colorectal cancer treatable with curative intent .
METHODS	Randomized clinical trial in 39 National Health Service hospitals in the United Kingdom ; 1202 eligible participants were recruited between January 2003 and August 2009 who had undergone curative surgery for primary colorectal cancer , including adjuvant treatment if indicated , with no evidence of residual disease on investigation .
METHODS	Participants were randomly assigned to 1 of 4 groups : CEA only ( n = 300 ) , CT only ( n = 299 ) , CEA+CT ( n = 302 ) , or minimum follow-up ( n = 301 ) .
METHODS	Blood CEA was measured every 3 months for 2 years , then every 6 months for 3 years ; CT scans of the chest , abdomen , and pelvis were performed every 6 months for 2 years , then annually for 3 years ; and the minimum follow-up group received follow-up if symptoms occurred .
METHODS	The primary outcome was surgical treatment of recurrence with curative intent ; secondary outcomes were mortality ( total and colorectal cancer ) , time to detection of recurrence , and survival after treatment of recurrence with curative intent .
RESULTS	After a mean 4.4 ( SD , 0.8 ) years of observation , cancer recurrence was detected in 199 participants ( 16.6 % ; 95 % CI , 14.5 % -18.7 % ) overall ; 71 of 1202 participants ( 5.9 % ; 95 % CI , 4.6 % -7.2 % ) were treated for recurrence with curative intent , with little difference according to Dukes staging ( stage A , 5.1 % [ 13/254 ] ; stage B , 6.1 % [ 34/553 ] ; stage C , 6.2 % [ 22/354 ] ) .
RESULTS	Surgical treatment of recurrence with curative intent was 2.3 % ( 7/301 ) in the minimum follow-up group , 6.7 % ( 20/300 ) in the CEA group , 8 % ( 24/299 ) in the CT group , and 6.6 % ( 20/302 ) in the CEA+CT group .
RESULTS	Compared with minimum follow-up , the absolute difference in the percentage of patients treated with curative intent in the CEA group was 4.4 % ( 95 % CI , 1.0 % -7.9 % ; adjusted odds ratio [ OR ] , 3.00 ; 95 % CI , 1.23-7 .33 ) , in the CT group was 5.7 % ( 95 % CI , 2.2 % -9.5 % ; adjusted OR , 3.63 ; 95 % CI , 1.51-8 .69 ) , and in the CEA+CT group was 4.3 % ( 95 % CI , 1.0 % -7.9 % ; adjusted OR , 3.10 ; 95 % CI , 1.10-8 .71 ) .
RESULTS	The number of deaths was not significantly different in the combined intensive monitoring groups ( CEA , CT , and CEA+CT ; 18.2 % [ 164/901 ] ) vs the minimum follow-up group ( 15.9 % [ 48/301 ] ; difference , 2.3 % ; 95 % CI , -2.6 % to 7.1 % ) .
CONCLUSIONS	Among patients who had undergone curative surgery for primary colorectal cancer , intensive imaging or CEA screening each provided an increased rate of surgical treatment of recurrence with curative intent compared with minimal follow-up ; there was no advantage in combining CEA and CT. .
CONCLUSIONS	If there is a survival advantage to any strategy , it is likely to be small .
BACKGROUND	isrctn.org Identifier : 41458548 .

###25038794
BACKGROUND	Bacterial prostatitis ( BP ) is a common condition accounting responsible for about 5-10 % of all prostatitis cases ; chronic bacterial prostatitis ( CBP ) classified as type II , are less common but is a condition that significantly hampers the quality of life , ( QoL ) because not only is it a physical condition but also a psychological distress .
BACKGROUND	Commonly patients are treated with antibiotics alone , and in particular fluoroquinolones are suggested by the European Urology guidelines .
BACKGROUND	This approach , although recommended , may not be enough .
BACKGROUND	Thus , a multimodal approach to the prolonged antibiotic therapy may be helpful .
METHODS	210 patients affected by chronic bacterial prostatitis were enrolled in the study .
METHODS	All patients were positive to Meares-Stamey test and symptoms duration was > 3 months .
METHODS	The purpose of the study was to evaluate the efficacy of a long lasting therapy with a fluoroquinolone in association with a nutraceutical supplement ( prulifloxacin 600 mg for 21 days and an association of Serenoa repens 320 mg , Lactobacillus Sporogens 200 mg , Arbutin 100 mg for 30 days ) .
METHODS	Patients were randomized in two groups ( A and B ) receiving respectively antibiotic alone and an association of antibiotic plus supplement .
RESULTS	Biological recurrence at 2 months in Group A was observed in 21 patients ( 27.6 % ) and in Group B in 6 patients ( 7.8 % ) .
RESULTS	Uropathogens found at the first follow-up were for the majority Gram - ( E. coli and Enterobacter spp . )
RESULTS	A statistically significant difference was found at the time of the follow-up between Group A and B in the NIH-CPSI questionnaire score , symptoms evidence and serum PSA .
CONCLUSIONS	Broad band , short-lasting antibiotic therapy in association with a nutritional supplement ( serenoa repens , lactobacillus sporogens and arbutin ) show better control and recurrence rate on patients affected by chronic bacterial prostatitits in comparison with antibiotic treatment alone .
BACKGROUND	NCT02130713 .
BACKGROUND	Date of trial Registration : 30/04/2014 .

###24562349
BACKGROUND	Limited comparative , prospective data exist regarding cardiovascular risk factors in HIV-infected women starting antiretroviral therapy in Africa .
METHODS	In 7 African countries , 741 women with CD4 < 200 cells/mm were randomized to tenofovir/emtricitabine ( TDF/FTC ) plus either nevirapine ( NVP , n = 370 ) or lopinavir/ritonavir ( LPV/r , n = 371 ) .
METHODS	Lipids and blood pressure ( BP ) were evaluated at entry , 48 , 96 , and 144 weeks .
METHODS	Multivariable linear and logistic regression models were used to evaluate mean risk factor changes and clinically relevant risk factor changes .
RESULTS	At entry , both NVP and LPV/r groups were similar regarding age [ mean = 33.5 ( SD = 7.1 ) years ] , CD4 [ 129 ( 67 ) cells/mm ] , and HIV-1 RNA [ 5.1 ( 0.6 ) log10 copies/mL ] .
RESULTS	Nearly , all women had normal lipids and BP except for high-density lipoprotein ( HDL ) - cholesterol .
RESULTS	Over 144 weeks , the LPV/r compared with NVP group had significantly greater mean lipid increases ( eg , non-HDL : +29 vs. +13 mg/dL ) and smaller HDL increases ( +12 vs. +21 mg/dL ) .
RESULTS	In contrast , the NVP compared with LPV/r group had greater mean increases in BP ( eg , diastolic BP : +5 vs. -0.5 mm Hg ) .
RESULTS	Significantly , more women assigned LPV/r had week 144 `` abnormal '' lipid levels ( eg , HDL 29.7 % vs. 14.8 % and triglycerides 28.6 % vs. 8.2 % ) , and significantly , more women assigned NVP had `` abnormal '' BP ( eg , diastolic BP 22.7 % vs. 6.5 % ) .
RESULTS	Most differences remained significant when adjusted for baseline risk factor , age , CD4 , and HIV-1 RNA .
CONCLUSIONS	In HIV-infected women initiating antiretroviral therapy in Africa , LPV/r + TDF/FTC was associated with less favorable changes in lipids , and use of NVP + TDF/FTC was associated with less favorable changes in BP .

###25080051
OBJECTIVE	Sepsis treatment guidelines recommend macrocirculatory hemodynamic optimization ; however , microcirculatory dysfunction is integral to sepsis pathogenesis .
OBJECTIVE	We aimed to test the hypothesis that following macrocirculatory optimization , inhaled nitric oxide would improve microcirculation in patients with sepsis and that improved microcirculation would improve lactate clearance and multiple organ dysfunction .
METHODS	Randomized , sham-controlled clinical trial .
METHODS	Single urban academic medical center .
METHODS	Adult patients with severe sepsis and systolic blood pressure less than 90 mm Hg despite intravascular volume expansion and/or serum lactate greater than or equal to 4.0 mmol/L .
METHODS	After achievement of macrocirculatory resuscitation goals , we randomized patients to 6 hours of inhaled nitric oxide ( 40 ppm ) or sham inhaled nitric oxide administration .
METHODS	We administered study drug via a specialized delivery device that concealed treatment allocation so that investigators and clinical staff remained blinded .
RESULTS	We performed sidestream dark-field videomicroscopy of the sublingual microcirculation prior to and 2 hours after study drug initiation .
RESULTS	The primary outcome measure was the change in microcirculatory flow index .
RESULTS	Secondary outcomes were lactate clearance and change in Sequential Organ Failure Assessment score .
RESULTS	We enrolled 50 patients ( 28 of 50 [ 56 % ] requiring vasopressor agents ; 15 of 50 [ 30 % ] died ) .
RESULTS	Although inhaled nitric oxide significantly raised plasma nitrite levels , it did not improve microcirculatory flow , lactate clearance , or organ dysfunction .
RESULTS	In contrast to previous studies conducted during the earliest phase of resuscitation , we found no association between changes in microcirculatory flow and lactate clearance or organ dysfunction .
CONCLUSIONS	Following macrocirculatory optimization , inhaled nitric oxide at 40 ppm did not augment microcirculatory perfusion in patients with sepsis .
CONCLUSIONS	Further , we found no association between microcirculatory perfusion and multiple organ dysfunction after initial resuscitation .

###25068452
OBJECTIVE	Survivors of breast cancer experience stress and are at risk for depressive symptoms following primary treatment .
OBJECTIVE	Group-based interventions such as cognitive-behavioral stress management ( CBSM ) delivered postsurgery for nonmetastatic breast cancer ( BCa ) were previously associated with fewer depressive symptoms over a 12-month follow-up ; few studies have examined the longer-term benefits of such psychosocial interventions .
OBJECTIVE	This 5-year follow-up study of a previously conducted trial ( #NCT 01422551 ) tested whether group-based CBSM following surgery for nonmetastatic BCa was associated with fewer depressive symptoms .
METHODS	Women ( N = 240 ) with Stage 0-IIIb BCa were recruited 2-10 weeks postsurgery and randomized to a 10-week CBSM intervention group or a 1-day psycho-educational control group .
METHODS	Women were recontacted 5 years poststudy enrollment and reconsented to participate in the follow-up study ( N = 130 ) .
METHODS	Depressive symptomatology was assessed using the Center for Epidemiologic Studies-Depression scale ( CES-D ) .
METHODS	ANOVA and ANCOVA analyses were employed to test for group differences on the CES-D at 5-year follow-up accounting for relevant covariates .
RESULTS	Participants assigned to CBSM reported significantly fewer depressive symptoms ( M = 9.99 , SE = 0.93 ) at the follow-up compared with those in the control group ( M = 12.97 , SE = 0.99 ) , p = .030 .
RESULTS	With covariates , the group difference remained significant , p = .012 .
CONCLUSIONS	Women who received CBSM postsurgery for BCa reported fewer depressive symptoms than those in the control group in this 5-year follow-up .
CONCLUSIONS	Psychosocial interventions early in treatment may influence long-term psychological well-being in BCa survivors .

###24559847
BACKGROUND	Speckle tracking is a relatively new , largely angle-independent technique used for the evaluation of myocardial longitudinal strain ( LS ) .
BACKGROUND	However , significant differences have been reported between LS values obtained by speckle tracking with the first generation of software products .
OBJECTIVE	To compare LS values obtained with the most recently released equipment from two manufacturers .
METHODS	Systematic scanning with head-to-head acquisition with no modification of the patient 's position was performed in 64 patients with equipment from two different manufacturers , with subsequent off-line post-processing for speckle tracking LS assessment ( Philips QLAB 9.0 and General Electric [ GE ] EchoPAC BT12 ) .
METHODS	The interobserver variability of each software product was tested on a randomly selected set of 20 echocardiograms from the study population .
RESULTS	GE and Philips interobserver coefficients of variation ( CVs ) for global LS ( GLS ) were 6.63 % and 5.87 % , respectively , indicating good reproducibility .
RESULTS	Reproducibility was very variable for regional and segmental LS values , with CVs ranging from 7.58 % to 49.21 % with both software products .
RESULTS	The concordance correlation coefficient ( CCC ) between GLS values was high at 0.95 , indicating substantial agreement between the two methods .
RESULTS	While good agreement was observed between midwall and apical regional strains with the two software products , basal regional strains were poorly correlated .
RESULTS	The agreement between the two software products at a segmental level was very variable ; the highest correlation was obtained for the apical cap ( CCC 0.90 ) and the poorest for basal segments ( CCC range 0.31-0 .56 ) .
CONCLUSIONS	A high level of agreement and reproducibility for global but not for basal regional or segmental LS was found with two vendor-dependent software products .
CONCLUSIONS	This finding may help to reinforce clinical acceptance of GLS in everyday clinical practice .

###26079777
BACKGROUND	Tight glucose control ( TGC ) reduces morbidity and mortality in patients undergoing elective cardiac surgery , but only limited data about its optimal timing are available to date .
OBJECTIVE	The purpose of this article was to compare the effects of perioperative vs postoperative initiation of TGC on postoperative adverse events in cardiac surgery patients .
METHODS	This was a single center , single-blind , parallel-group , randomized controlled trial .
METHODS	The setting was an academic tertiary hospital .
METHODS	Participants were 2383 hemodynamically stable patients undergoing major cardiac surgery with expected postoperative intensive care unit treatment for at least 2 consecutive days .
METHODS	Intensive insulin therapy was initiated perioperatively or postoperatively with a target glucose range of 4.4 to 6.1 mmol/L .
METHODS	Adverse events from any cause during postoperative hospital stay were compared .
RESULTS	In the whole cohort , perioperatively initiated TGC markedly reduced the number of postoperative complications ( 23.2 % vs 34.1 % , 95 % confidence interval [ CI ] , 0.60-0 .78 ) despite only minimal improvement in glucose control ( blood glucose , 6.6 0.7 vs 6.7 0.8 mmol/L , P < .001 ; time in target range , 39.3 % 13.7 % vs 37.3 % 13.8 % , P < .001 ) .
RESULTS	The positive effects of TGC on postoperative complications were driven by nondiabetic subjects ( 21.3 % vs 33.7 % , 95 % CI , 0.54-0 .74 ; blood glucose 6.5 0.6 vs 6.6 0.8 mmol/L , not significant ; time in target range , 40.8 % 13.6 % vs 39.7 % 13.8 % , not significant ) , whereas no significant effect was seen in diabetic patients ( 29.4 % vs 35.1 % , 95 % CI , 0.66-1 .06 ) despite significantly better glucose control in the perioperative group ( blood glucose , 6.9 1.0 vs 7.1 0.8 mmol/L , P < .001 ; time in target range , 34.3 % 12.7 % vs 30.8 % 11.5 % , P < .001 ) .
CONCLUSIONS	Perioperative initiation of intensive insulin therapy during cardiac surgery reduces postoperative morbidity in nondiabetic patients while having a minimal effect in diabetic subjects .

###24585265
OBJECTIVE	Proof-of-concept evidence suggests that mechanical ischaemic post-conditioning ( PostC ) reduces infarct size when applied immediately after culprit coronary artery re-opening in ST-elevation myocardial infarction ( STEMI ) patients with thrombolysis in myocardial infarction 0-1 ( TIMI 0-1 ) flow grade at admission .
OBJECTIVE	Whether PostC might also be protective in patients with a TIMI 2-3 flow grade on admission ( corresponding to a delayed application of the post-conditioning algorithm ) remains undetermined .
RESULTS	In this multi-centre , randomized , single-blinded , controlled study , STEMI patients with a 2-3 TIMI coronary flow grade at admission underwent direct stenting of the culprit lesion , followed ( PostC group ) or not ( control group ) by four cycles of ( 1 min inflation/1 min deflation ) of the angioplasty balloon to trigger post-conditioning .
RESULTS	Infarct size was assessed both by cardiac magnetic resonance at Day 5 ( primary endpoint ) and cardiac enzymes release ( secondary endpoint ) .
RESULTS	Ninety-nine patients were prospectively enrolled .
RESULTS	Baseline characteristics were comparable between control and PostC groups .
RESULTS	Despite comparable size of area at risk ( AAR ) ( 38 12 vs. 38 13 % of the LV circumference , respectively , P = 0.89 ) and similar time from onset to intervention ( 249 148 vs. 263 209 min , respectively , P = 0.93 ) in the two groups , PostC did not significantly reduce cardiac magnetic resonance infarct size ( 23 17 and 21 18 g in the treated vs. control group , respectively , P = 0.64 ) .
RESULTS	Similar results were found when using creatine kinase and troponin I release , even after adjustment for the size of the AAR .
CONCLUSIONS	This study shows that infarct size reduction by mechanical ischaemic PostC is lost when applied to patients with a TIMI 2-3 flow grade at admission .
CONCLUSIONS	This indicates that the timing of the protective intervention with respect to the onset of reperfusion is a key factor for preventing lethal reperfusion injury in STEMI patients .
BACKGROUND	NCT01483755 .

###25104109
BACKGROUND	In the AFFIRM trial of patients with metastatic castration-resistant prostate cancer after progression with docetaxel treatment , enzalutamide significantly increased overall survival compared with placebo .
BACKGROUND	Here we present the prospectively defined analyses of some secondary endpoints , including occurrence of skeletal-related events , measures of pain control , and patient-reported health-related quality of life ( HRQoL ) .
METHODS	In this phase 3 , double-blind trial , patients were randomly assigned ( 2:1 ) to receive enzalutamide 160 mg/day or placebo orally , stratified by ECOG baseline performance status ( 0 or 1 vs 2 ) and mean pain score ( Brief Pain Inventory-Short Form [ BPI-SF ] question 3 worst pain , score 3 vs 4 ) .
METHODS	Secondary endpoints were time to first skeletal-related event ( defined as radiation therapy or surgery to bone ) ; change from baseline to week 13 in pain severity and interference ; pain palliation and progression at week 13 ; time to pain progression ; overall improvement in HRQoL ; improvements in HRQoL domains ; and time to HRQoL deterioration .
METHODS	Analysis was done on the intention-to-treat population for each endpoint .
METHODS	AFFIRM is registered with ClinicalTrials.gov , number NCT00974311 .
RESULTS	Median time to first skeletal-related event in the enzalutamide ( n = 800 ) and placebo ( n = 399 ) groups was 167 months ( 95 % CI 146 to 191 ) and 133 months ( 95 % CI 99 to not yet reached ) , respectively ( hazard ratio [ HR ] 069 [ 95 % CI 057-084 ] ; p = 00001 ) .
RESULTS	Pain progression at week 13 occurred in 174 ( 28 % ) of 625 evaluable patients in the enzalutamide group versus 101 ( 39 % ) of 259 patients in the placebo group ( difference -112 % , 95 % CI -181 to -43 ; p = 00018 ) .
RESULTS	Median time to pain progression was not yet reached in the enzalutamide group ( 95 % CI not yet reached to not yet reached ) versus 138 ( 138 to not yet reached ) months in the placebo group ( HR 056 [ 95 % CI 041 to 078 ] ; p = 00004 ) .
RESULTS	Mean treatment effects for pain severity ( mean change from baseline in the enzalutamide group -015 , 95 % CI -028 to -002 , vs placebo 050 , 029 to 070 ; difference -065 , 95 % CI -089 to -041 ; p < 00001 ) and interference ( -001 , -018 to 016 , vs 074 , 047 to 100 ; respectively , difference -074 , 95 % -106 to -043 ; p < 00001 ) were significantly better with enzalutamide than with placebo .
RESULTS	22 ( 45 % ) of 49 evaluable patients in the enzalutamide group reported pain palliation at week 13 versus one ( 7 % ) of 15 in the placebo group ( difference 382 % , 95 % CI 194-570 ; p = 00079 ) .
RESULTS	Overall improvement in HRQoL was reported in more patients receiving enzalutamide ( 275 [ 42 % ] of 652 ) than in those receiving placebo ( 36 [ 15 % ] of 248 ; p < 00001 ) .
RESULTS	Patients in the enzalutamide group had longer median time to HRQoL deterioration than did those in the placebo group ( 90 months , 95 % CI 83-111 , vs 37 months , 95 % CI 30-42 ; HR 045 , 95 % CI 037-055 ; p < 00001 ) in risk of deterioration .
CONCLUSIONS	Our results show that , in addition to improving overall survival , enzalutamide improves wellbeing and everyday functioning of patients with metastatic castration-resistant prostate cancer .
BACKGROUND	Astellas Pharma and Medivation .

###24836393
BACKGROUND	MK-3641 is a short ragweed sublingual tablet under investigation for immunotherapy of ragweed pollen-induced allergic rhinitis .
OBJECTIVE	To characterize the safety and tolerability of a ragweed sublingual tablet ( Merck/ALK-Abell ) in ragweed-allergic adults with or without conjunctivitis .
METHODS	Data from 4 randomized , double-blinded , placebo-controlled trials of MK-3641 ( 2 28-day and 2 52-week trials ) were evaluated .
METHODS	Pooled analyses examined short-term safety over 28 days from all 4 trials and long-term safety from the 52-week trials .
RESULTS	Across all studies , 757 , 198 , 454 , and 1,058 subjects were randomized to placebo or 1.5 , 6 , or 12 Amb a 1-U of MK-3641 , respectively .
RESULTS	Treatment-related adverse events were more frequent in the 6 - and 12-Amb a 1-U MK-3641 groups than in the placebo group and were primarily local application-site reactions occurring in the first few days of treatment .
RESULTS	There was no treatment-associated loss of asthma control or worsening of asthma associated with treatment .
RESULTS	No swellings led to airway obstruction or respiratory compromise .
RESULTS	No treatment-related anaphylactic shock , life-threatening , or serious treatment-related adverse events were reported for any MK-3641 dose .
RESULTS	Of the 1,707 MK-3641-treated subjects , 1 systemic ( anaphylactic ) reaction was reported ( 0.06 % ) .
RESULTS	The 52-week long-term assessment was generally similar to the safety profile based on the 28-day assessment .
CONCLUSIONS	MK-3641 doses up to and including 12 Amb a 1-U were well tolerated , with no unexpected safety findings .
CONCLUSIONS	Sublingual immunotherapy risks such as worsening asthma or airway swellings that could cause airway obstruction were not observed .
CONCLUSIONS	Systemic reactions and use of epinephrine were uncommon .
CONCLUSIONS	In these studies , after the first dose was administered in a health care setting , self-administration was well tolerated .
BACKGROUND	clinicaltrials.gov Identifiers : NCT01469182 , NCT00783198 , NCT00770315 , and NCT00978029 .

###24286991
OBJECTIVE	The Hopkins Symptom Checklist-25 ( HSCL-25 ) has often been used in cross-cultural settings and in studies focussing on asylum seekers , refugees etc. .
OBJECTIVE	It is available in a number of languages .
OBJECTIVE	The present study investigates the psychometric properties of the German version of the HSCL-25 and delivers population-based norms .
METHODS	Psychometric properties are investigated in a population-based representative sample of the German general population ( N = 2516 ) .
METHODS	Seven different factorial models are compared using confirmatory factor analysis .
RESULTS	Two out of the seven models show the best model fit .
RESULTS	Because of the high inter-correlations of the factors of the tripartite model , the bifactor model is the preferable factor solution .
RESULTS	The internal consistencies ( Cronbach 's alpha ) were 0.84 , 0.92 , and 0.94 for the anxiety , the depression and the total score , respectively .
RESULTS	The correlations of both subscales of this model with the subscales of the Brief-Symptom-Inventory-18 or the Patient Health Questionnaire-4 point out , that there is only marginal differential information of the subscales .
CONCLUSIONS	Considering the third ( `` general '' ) factor of the bifactor model with all items loading on it and the absence of differential correlations of the subscales with the external criteria ( PHQ-4 , BSI-18 ) the HSCL-25 seems to assess something like `` mental distress '' with a focus on symptoms of depression and anxiety .
CONCLUSIONS	The population-based norms support the application of the HSCL-25 for individual diagnostics as well as for the comparison of specific samples with the general population .

###25473939
BACKGROUND	Effective antiinflammatory therapies are needed for the treatment of asthma , but preferably without the systemic adverse effects of glucocorticosteroids .
OBJECTIVE	We evaluated the effect of an inhaled nonsteroidal glucocorticoid receptor agonist , AZD5423 , on allergen-induced responses .
METHODS	Twenty subjects with mild allergic asthma were randomized to receive 7 days of treatment with nebulized AZD5423 ( 75 or 300 g ) once daily , budesonide 200 g twice daily via Turbuhaler , or placebo in a double-blind , four-period , crossover design study .
METHODS	Allergen challenge was performed on Day 6 .
RESULTS	FEV1 was measured repeatedly for 7 hours after allergen challenge for early and late asthmatic responses .
RESULTS	Sputum inflammatory cells was measured before and at 7 and 24 hours after allergen challenge , and methacholine airway responsiveness was measured before and 24 hours after allergen challenge .
RESULTS	AZD5423 significantly attenuated the fall in FEV1 during the late asthmatic response ( both doses led to an 8.7 % fall ) versus placebo ( 14 % fall ) ( P < 0.05 ) with no effect of budesonide ( 12.5 % fall ) versus placebo ( P > 0.05 ) .
RESULTS	There was no effect on the fall in FEV1 during early asthmatic response .
RESULTS	AZD5423 300 and 75 g significantly attenuated allergen-induced sputum eosinophilia by 63 and 61 % at 7 hours , respectively , and by 46 and 34 % at 24 hours after allergen challenge , respectively , versus placebo ( all P < 0.05 ) .
RESULTS	Budesonide did not reduce allergen-induced sputum eosinophilia versus placebo .
RESULTS	AZD5423 at 300 g significantly attenuated allergen-induced airway hyperresponsiveness at 24 hours after allergen challenge versus placebo ( P < 0.05 ) .
RESULTS	Both doses of AZD5423 were well tolerated .
CONCLUSIONS	Seven-day treatment with inhalation of the nonsteroidal glucocorticoid receptor agonist AZD5423 effectively reduced allergen-induced responses in subjects with mild allergic asthma .
CONCLUSIONS	Clinical trial registered with www.clinicaltrials.gov ( NCT01225549 ) .

###24809921
BACKGROUND	The incidence of stent restenosis ( SR ) has risen with as more patients are being treated with drug-eluting stents ( DESs ) .
BACKGROUND	Trimetazidine has multiple favorable effects on the cardiovascular system .
BACKGROUND	Here , we aimed to evaluate whether chronic treatment with trimetazidine reduced the incidence of SR. .
METHODS	From January 2009 to December 2011 at Chinese PLA General Hospital , 768 patients were enrolled and randomized into the trimetazidine treatment group ( TG , n = 384 ) and control group ( CG , n = 384 ) .
METHODS	After DES implantation , all patients were treated with regular medication .
METHODS	In the TG , trimetazidine was administrated at 20mg tid for at least 30days .
METHODS	All patients received follow-up angiography 9-13 months after discharge .
METHODS	Major adverse cardiac and cerebrovascular events ( MACCEs ) were recorded .
RESULTS	Six hundred thirty-five patients were included in the final analysis ( TG , n = 312 ; CG , n = 323 ) .
RESULTS	SR occurred in 49 ( 7.7 % ) patients .
RESULTS	The TG had a lower incidence of SR compared to the CG ( 4.2 % vs. 11.1 % , p = 0.001 ) .
RESULTS	At the 30-day follow-up , the TG exhibited a higher left ventricular ejection fraction than the CG ( 65.4 10.7 vs. 63.1 10.4 , p = 0.006 ) .
RESULTS	The incidence of MACCEs was also lower in the TG at the 1-year follow-up ( 6.1 % vs. 10.8 % , p = 0.032 ) .
RESULTS	Further multivariate analysis revealed that trimetazidine treatment was a predictor for SR ( OR : 0.376 ; 95 % CI : 0.196-0 .721 ; p = 0.003 ) .
CONCLUSIONS	Trimetazidine treatment effectively reduced the incidence of SR and MACCEs after DES implantation at the 1-year follow-up .

###25262862
BACKGROUND	Postoperative atrial fibrillation ( POAF ) remains common after coronary artery bypass grafting ( CABG ) .
BACKGROUND	Limited efforts to intervene on cardiac autonomic ganglionic plexi ( AGP ) during surgery show mixed results .
BACKGROUND	In this pilot study , we evaluated the safety and feasibility of map-guided ablation of AGPs during isolated CABG in the prevention of POAF .
METHODS	In this pilot study , patients undergoing isolated CABG were randomized into an intervention group ( mapping and ablation of AGP [ AGP + ] group ) , and a control group ( no mapping and ablation [ AGP - ] group ) .
METHODS	Using high-frequency stimulation , active AGPs were identified and ablated intraoperatively using radiofrequency .
METHODS	Continuous rhythm monitoring , serum electrolytes , postoperative medications , and postoperative complications were recorded until discharge .
RESULTS	Randomization of 47 patients ( 24 AGP + and 23 AGP - ) resulted in similar baseline characteristics , past medical history , and preoperative medication use .
RESULTS	The intervention added a median of 14 minutes to the operative time .
RESULTS	The incidence of POAF , mean time inPOAF , and median length of stay in hospital were : AGP + 21 % vs AGP - 30 % ; AGP + 298 minutes vs AGP - 514 minutes ; AGP + 5 days vs AGP - 6 days ; respectively ) .
RESULTS	Postoperative complications , medication use , and daily serum electrolyte profiles were similar in both groups .
CONCLUSIONS	This pilot study demonstrated the safety and feasibility of mapping and ablation of AGP during CABG with minimal added operative time .
CONCLUSIONS	Results further suggest a potentially clinically significant effect on POAF .
CONCLUSIONS	A multicentre trial is warranted .

###25081363
OBJECTIVE	We have previously shown that 500ml of a foamed drink ( ` foam ' ) significantly improved appetite versus a non-foamed control .
OBJECTIVE	The objectives of this research were to assess the effect of smaller volumes of foams on appetite , and the potential benefits of foam ingestion and its timing on appetite measures in a reduced-energy context .
METHODS	Two randomized , parallel design studies ( pre - and main study ) were conducted using healthy adult subjects .
METHODS	Pre-study : 133 subjects ( age 18-50 years , body mass index ( BMI ) 20-32kgm ( -2 ) ) each consumed either 10 , 25 , 50 , 100 , 150 or 250ml foamed meal replacer ( ~ 0.2 kcalml ( -1 ) ) , 150min after a fixed breakfast .
METHODS	Main study : four groups of subjects ( n = 134 ; age 18-60 years , BMI 22.5-35 .0 kgm ( -2 ) ) consumed 200ml/22kcal foam ( based on pre-study results ) immediately after main meals ( M ) , after snacks ( S ) , in-between snacks and main meals ( I ) or not at all ( control , C ) within 1 day of a reduced-energy meal plan consisting of three main meals and three snacks .
METHODS	Measurements included self-reported appetite ( six scales , reported as area under the curve ( AUC ) ) and ( main study only ) end-of-day appetite questionnaire .
RESULTS	Pre-study : the strongest effect on appetite was produced by 250ml ( consistent across scales ) , whereas 150ml showed more pronounced effects than 100 and 50ml in most scales .
RESULTS	Volumes 10 and 25ml had no effects on any scale .
RESULTS	Main study : 200ml foam reduced appetite AUC substantially in all treatments , particularly M ( for example , hunger AUC reduced by 35 % ( P < 0.001 ) , 28 % ( P < 0.05 ) and 20 % ( P = 0.11 ) for M , S and I , respectively versus C ) .
RESULTS	A strong reduction in ` appetite for a snack ' was seen for all timings ( all P < 0.05 ) .
RESULTS	The end-of-day appetite ratings confirmed these findings .
CONCLUSIONS	Modest amounts of a low-energy foam can reduce appetite measures during a 1-day reduced-energy meal plan .

###25595231
OBJECTIVE	To provide comparisons and a worked example of item - and scale-level evaluations based on three psychometric methods used in patient-reported outcome development-classical test theory ( CTT ) , item response theory ( IRT ) , and Rasch measurement theory ( RMT ) - in an analysis of the National Eye Institute Visual Functioning Questionnaire ( VFQ-25 ) .
METHODS	Baseline VFQ-25 data from 240 participants with diabetic macular edema from a randomized , double-masked , multicenter clinical trial were used to evaluate the VFQ at the total score level .
METHODS	CTT , RMT , and IRT evaluations were conducted , and results were assessed in a head-to-head comparison .
RESULTS	Results were similar across the three methods , with IRT and RMT providing more detailed diagnostic information on how to improve the scale .
RESULTS	CTT led to the identification of two problematic items that threaten the validity of the overall scale score , sets of redundant items , and skewed response categories .
RESULTS	IRT and RMT additionally identified poor fit for one item , many locally dependent items , poor targeting , and disordering of over half the response categories .
CONCLUSIONS	Selection of a psychometric approach depends on many factors .
CONCLUSIONS	Researchers should justify their evaluation method and consider the intended audience .
CONCLUSIONS	If the instrument is being developed for descriptive purposes and on a restricted budget , a cursory examination of the CTT-based psychometric properties may be all that is possible .
CONCLUSIONS	In a high-stakes situation , such as the development of a patient-reported outcome instrument for consideration in pharmaceutical labeling , however , a thorough psychometric evaluation including IRT or RMT should be considered , with final item-level decisions made on the basis of both quantitative and qualitative results .

###25012577
OBJECTIVE	The potential negative metabolic interaction between proton pump inhibitors and clopidogrel is an unsolved issue .
OBJECTIVE	We hypothesized that doubling the clopidogrel maintenance dose ( 150 mg ) would be less effective than switching to prasugrel 10 mg maintenance dose ( MD ) to overcome this negative interaction .
RESULTS	In a randomized study with a factorial design , 82 stable coronary artery disease patients treated with 75 mg clopidogrel MD and aspirin were assigned to receive in a double blind fashion lansoprazole ( 30 mg/day ) or placebo and to receive in an open fashion 150 mg clopidogrel MD or 10 mg prasugrel MD. .
RESULTS	The primary endpoint was the relative change in residual platelet reactivity over the 14-day study period [ ( RPA14day-RPAbaseline ) / RPAbaseline ] .
RESULTS	The effect of doubling the clopidogrel MD on relative change in RPA was neutralized by lansoprazole ( -53.648.4 % versus +0.853.7 % without and with lansoprazole , respectively , p = 0.02 ) whereas 10 mg of prasugrel MD dramatically reduced RPA irrespective of lansoprazole co-administration ( -81.8 % 24.8 % vs. -72.9 % 32.9 % without and with lansoprazole , respectively , p = NS ) .
RESULTS	Lansoprazole exposure was the only parameter with a significant interaction with RPA among subgroups .
CONCLUSIONS	The higher platelet inhibitory effect obtained by doubling the clopidogrel MD was totally neutralized by the co-administration of lansoprazole .
CONCLUSIONS	This drug interaction was not observed with prasugrel 10 mg .

###24801818
BACKGROUND	Children undergoing procedures in pediatric health care facilities and their families have been shown to benefit from psychosocial services and interventions such as those provided by a Certified Child Life Specialist ( CCLS ) .
BACKGROUND	The comprehensive impact of a CCLS in a pediatric imaging department is well recognized anecdotally but has not been examined in a prospective or randomized controlled fashion .
OBJECTIVE	We prospectively assessed the impact of a CCLS on parent satisfaction , staff satisfaction , child satisfaction , and parent and staff perceptions of child pain and distress in a pediatric imaging department .
METHODS	Eligible children between 1 and 12 years of age ( n = 137 ) presenting to the pediatric imaging department for an imaging procedure were randomly assigned to an intervention or control arm .
METHODS	Those assigned to the intervention received the comprehensive services of a CCLS .
METHODS	The control group received standard of care , which did not include any child life services .
METHODS	Quantitative measures of satisfaction and perception of child pain and distress were assessed by parents and staff using a written 5-point Likert scale questionnaire after the imaging procedure .
METHODS	Children 4 and older were asked to answer 3 questions on a 3-point scale .
RESULTS	Statistically significant differences between the intervention and control groups were found in 19 out of 24 measures .
RESULTS	Parents in the intervention group indicated higher satisfaction and a lower perception of their child 's pain and distress .
RESULTS	Staff in the intervention group indicated greater child cooperation and a lower perception of the child 's pain and distress .
RESULTS	Children in the intervention group indicated a better overall experience and less fear than those in the control group .
CONCLUSIONS	Child life specialists have a quantifiably positive impact on the care of children in imaging departments .
CONCLUSIONS	Measures of parent satisfaction , staff satisfaction , child satisfaction , child pain and child distress are shown to be positively impacted by the services of a CCLS .
CONCLUSIONS	These results have significant implications for hospitals striving to increase satisfaction , decrease costs and improve quality of care .
CONCLUSIONS	In a health care landscape that is changing quickly and increasingly focused on the cost of care , future research should assess whether the core tenants of the child life profession support and contribute quantifiably to high-quality , cost-effective practices in health care .

###24650818
OBJECTIVE	The first semester of college has been associated with increased drinking and sexual risk .
OBJECTIVE	However , it remains unclear why some drinking occasions result in experiencing negative sexual consequences whereas others do not .
OBJECTIVE	The current study used a diary-based approach to assess the event-level effect of alcohol use and previous adult/adolescent sexual victimization ( PSV ) on experiencing negative sex-related consequences in first-year college women .
METHODS	Participants ( N = 120 ) provided repeated measures of weekend drinking and sex-related consequences on the Friday and Saturday nights of six different weekends over the course of their first semester , resulting in 12 measured drinking occasions .
METHODS	A multilevel model was used to assess both between - and within-person effects of alcohol use and between-person effects of PSV on the likelihood of experiencing negative alcohol-related sexual consequences .
RESULTS	Findings revealed an important within-person association , such that every drink consumed above one 's mean was associated with a 13 % increase in the likelihood of experiencing negative consequences .
RESULTS	In addition , PSV had a significant main effect on experiencing negative sex-related consequences .
RESULTS	Individuals with PSV experienced nearly 2.5 times more sexual consequences than individuals without PSV .
CONCLUSIONS	These results yield important implications for prevention , particularly with respect to limiting `` above average '' alcohol consumption among women with a history of sexual victimization .

###24708832
BACKGROUND	Metabolic syndrome ( MetS ) is increasingly present in breast cancer survivors , possibly worsened by cancer-related treatments , such as chemotherapy .
BACKGROUND	MetS greatly increases risk of cardiovascular disease and diabetes , co-morbidities that could impair the survivorship experience , and possibly lead to cancer recurrence .
BACKGROUND	Exercise has been shown to positively influence quality of life ( QOL ) , physical function , muscular strength and endurance , reduce fatigue , and improve emotional well-being ; however , the impact on MetS components ( visceral adiposity , hyperglycemia , low serum high-density lipoprotein cholesterol , hypertriglyceridemia , and hypertension ) remains largely unknown .
BACKGROUND	In this trial , we aim to assess the effects of combined ( aerobic and resistance ) exercise on components of MetS , as well as on physical fitness and QOL , in breast cancer survivors soon after completing cancer-related treatments .
METHODS	This study is a prospective randomized controlled trial ( RCT ) investigating the effects of a 16-week supervised progressive aerobic and resistance exercise training intervention on MetS in 100 breast cancer survivors .
METHODS	Main inclusion criteria are histologically-confirmed breast cancer stage I-III , completion of chemotherapy and/or radiation within 6 months prior to initiation of the study , sedentary , and free from musculoskeletal disorders .
METHODS	The primary endpoint is MetS ; secondary endpoints include : muscle strength , shoulder function , cardiorespiratory fitness , body composition , bone mineral density , and QOL .
METHODS	Participants randomized to the Exercise group participate in 3 supervised weekly exercise sessions for 16 weeks .
METHODS	Participants randomized to the Control group are offered the same intervention after the 16-week period of observation .
CONCLUSIONS	This is the one of few RCTs examining the effects of exercise on MetS in breast cancer survivors .
CONCLUSIONS	Results will contribute a better understanding of metabolic disease-related effects of resistance and aerobic exercise training and inform intervention programs that will optimally improve physiological and psychosocial health during cancer survivorship , and that are ultimately aimed at improving prognosis .
BACKGROUND	NCT01140282 ;
BACKGROUND	June 10 , 2010 .

###24583430
OBJECTIVE	Our objective was to evaluate the effectiveness of combination therapy consisting of low-dose corticosteroids with weekly methotrexate in patients with cardiac sarcoidosis in whom long-term therapy is required .
OBJECTIVE	Combination therapy was selected because long-term standard corticosteroid therapy tends to result in various adverse effects and the steroid-sparing effects of methotrexate have been reported .
METHODS	This study was a small open-label study comparing long-term functional changes between patients who received combination therapy ( 5-15 mg/day of prednisolone and 6 mg/week of methotrexate ) and patients who received corticosteroids alone .
METHODS	The comparative analysis was based on the following therapeutic indexes : ejection fraction ( EF ) , left ventricular end-diastolic diameter ( LVDd ) on echocardiography , serum N-terminal fragment pro-brain natriuretic peptide ( NT-proBNP ) and cardiothoracic ratio ( CTR ) on plain chest radiographs .
METHODS	Seventeen patients with cardiac sarcoidosis were examined in the sarcoidosis clinic .
METHODS	Cardiac sarcoidosis was diagnosed based on the Japanese diagnostic guidelines published in 2006 .
RESULTS	The EF was significantly stabilized in the combination therapy group but not in the corticosteroids alone group at three years after the first treatment .
RESULTS	The CTR and NT-proBNP levels were significantly stabilized in the combination therapy group compared with those observed in the corticosteroids alone group at both three and five years after the first treatment .
RESULTS	The LVDd values tended to be stable in the combination therapy group compared with those observed in the corticosteroids alone group .
RESULTS	The combination therapy was associated with few adverse effects .
CONCLUSIONS	Weekly methotrexate therapy with daily small doses of corticosteroids stabilized the EF , CTR and NT-proBNP levels in the serum without eliciting adverse effects longitudinally .

###24323628
OBJECTIVE	In a multicenter study , patients of the German statutory insurance were encouraged to deal with their own rehabilitation goals using a questionnaire sent in advance of rehabilitation .
OBJECTIVE	How patients and physicians assess the benefits and practicability of this method should , in particular , be examined .
METHODS	In a randomized controlled study a questionnaire , based on the preparation booklet of the DRV Bund , was sent by the German statutory insurance to 2782 rehabilitation patients ( n ( ortho ) = 1406 , n ( onco ) 714 , n ( psy ) = 662 ) .
METHODS	For the intervention group , the questionnaire included , in addition to general information about rehabilitation goals , free text fields for the formulation of own goals .
METHODS	Patients were asked to bring the completed questionnaire to the admission interview .
METHODS	At the end of rehabilitation , satisfaction with participation in the goal-setting process and perceived usefulness of information on rehabilitation goals were captured .
METHODS	The doctors/psychologists responded to standardized items regarding various aspects of utility and practicability of the questionnaire .
RESULTS	34 % of the targeted rehabilitation patients brought the completed questionnaire to the admission interview .
RESULTS	For most of the rehabilitation patients goal setting is important ; 31.4 % reported the information obtained to rehabilitation goals to be very , and 62.9 % particularly helpful .
RESULTS	For practitioners , the questionnaire is likely to orient rehabilitation patients to rehabilitation goals : they reported that 56.6 % of the patients reflected about their goals and that 50 % were more familiar with the subject .
RESULTS	Physicians rated the handling and integration of the questionnaire into the interview , its format and layout as well as its benefits more positively than the surveyed psychologists .
RESULTS	These were more optimistic about the ability of rehabilitation patients to answer the questionnaire ( 62.5 % , physicians 47.2 % ) and define own goals ( 77.8 % , physicians 41.7 % ) .
CONCLUSIONS	The applied questionnaire has been well accepted by the majority of rehabilitation patients and practitioners as well as was judged to be practical and useful in important aspects .
CONCLUSIONS	A comprehensive implementation of the questionnaire proves to be promising , particularly in the context of oncological and orthopedic rehabilitation .
CONCLUSIONS	To increase the return of the questionnaire , alternative delivery options should be explored in future .
CONCLUSIONS	Against the background that rehabilitation patients and practitioners of psychosomatic medicine perceived the questionnaire as less helpful , it is also prudent to investigate whether indication-specific implementation strategies would be advantageous .

###25350085
OBJECTIVE	To evaluate the postoperative analgesic effects of epidural administration of morphine and neostigmine , either alone or in combination , in dogs .
METHODS	30 dogs undergoing orthopedic surgery on a pelvic limb .
METHODS	Anesthetic protocols were standardized .
METHODS	At the end of surgery , 10 dogs each received 1 of 3 epidural treatments : morphine ( 0.1 mg/kg ) , neostigmine ( 5 g/kg ) , or morphine plus neostigmine ( 0.1 mg/kg and 5 g/kg , respectively ) .
METHODS	Postoperative pain scores and the need for rescue analgesia were evaluated for 24 hours .
RESULTS	Pain scores were higher in the neostigmine group , compared with scores for the morphine-neostigmine group , at 2 and 24 hours after surgery and higher in the morphine group than in the morphine-neostigmine group at 2 and 4 hours .
RESULTS	During 24 hours , rescue analgesia was provided for 4 , 7 , and 2 of 10 dogs each in the morphine , neostigmine , and morphine-neostigmine groups , respectively .
RESULTS	The number of dogs given rescue analgesia was significantly different among groups at 2 , 3 , 4 , and 6 hours after surgery .
RESULTS	Dogs in the morphine and morphine-neostigmine groups had a lower probability of receiving rescue analgesia within 24 hours than did dogs in the neostigmine group .
CONCLUSIONS	When administered epidurally , morphine alone or in combination with neostigmine provided effective postoperative analgesia in most dogs after orthopedic surgery , whereas neostigmine alone did not .
CONCLUSIONS	Findings for this study suggested a potential role for neostigmine as an adjuvant for epidural analgesia in dogs undergoing orthopedic surgeries on the pelvic limbs .

###24606590
BACKGROUND	Diabetes and obesity have reached epidemic proportions in the U.S. with rates consistently higher among Hispanics as compared to non-Hispanic whites .
BACKGROUND	Among Hispanic women diagnosed with gestational diabetes mellitus ( GDM ) , 50 % will go on to develop type 2 diabetes within 5 years of the index pregnancy .
BACKGROUND	Although randomised controlled trials among adults with impaired glucose tolerance have shown that diet and physical activity reduce the risk of type 2 diabetes , such programs have not been tested in high-risk postpartum women .
BACKGROUND	The overall goal of this randomised controlled trial is to test the efficacy of a culturally and linguistically modified , individually-tailored lifestyle intervention to reduce risk factors for type 2 diabetes and cardiovascular disease among postpartum Hispanic women with a history of abnormal glucose tolerance during pregnancy .
METHODS	Hispanic pregnant women who screen positive for GDM will be recruited and randomly assigned to a Lifestyle Intervention ( n = 150 ) or a Health & Wellness ( control ) Intervention ( n = 150 ) .
METHODS	Multimodal contacts ( i.e. , in-person , telephone , and mailed materials ) will be used to deliver the intervention from late pregnancy ( 29 weeks gestation ) to 12 months postpartum .
METHODS	Targets of the intervention are to achieve Institute of Medicine Guidelines for postpartum weight loss ; American Congress of Obstetrician and Gynecologist guidelines for physical activity ; and American Diabetes Association guidelines for diet .
METHODS	The intervention draws from Social Cognitive Theory and the Transtheoretical Model and addresses the specific cultural and environmental challenges faced by low-income Hispanic women .
METHODS	Assessments will be conducted at enrollment , and at 6-weeks , 6-months , and 12-months postpartum by trained bicultural and bilingual personnel blinded to the intervention arm .
METHODS	Efficacy will be assessed via postpartum weight loss and biomarkers of insulin resistance and cardiovascular risk .
METHODS	Changes in physical activity and diet will be measured via 7-day actigraph data and three unannounced 24-hour dietary recalls at each assessment time period .
CONCLUSIONS	Hispanic women are the fastest growing minority group in the U.S. and have the highest rates of sedentary behavior and postpartum diabetes after a diagnosis of GDM .
CONCLUSIONS	This randomised trial uses a high-reach , low-cost strategy that can readily be translated into clinical practice in underserved and minority populations .
BACKGROUND	NCT01679210 .

###24444658
OBJECTIVE	Patients with chronic hepatitis C virus ( HCV ) infection and prior null response ( < 2 log HCV RNA decline after 12 weeks of PegIFN/RBV ) have limited options .
OBJECTIVE	We evaluated daclatasvir plus once - or twice-daily asunaprevir in non-cirrhotic genotype 1 null responders .
METHODS	In this randomized , phase 2a , open-label , 24-week treatment study , 101 patients received daclatasvir ( 60 mg ) once-daily .
METHODS	In addition , 38 genotype 1b patients received asunaprevir ( 200mg ) twice - ( DUAL A1 ) or once-daily ( DUAL A2 ) ; 36 genotype 1a and 5 genotype 1b patients received asunaprevir twice - ( QUAD B1 ) or once-daily ( QUAD B2 ) plus PegIFN/RBV ; and 18 genotype 1a and 4 genotype 1b patients received asunaprevir twice-daily plus ribavirin ( TRIPLE B3 ) .
METHODS	The primary endpoint was undetectable HCV RNA 12 weeks post-treatment ( sustained virologic response , SVR12 ) .
RESULTS	Across all groups , mean HCV RNA was 6 log IU/ml , and 99 % of patients had a non-CC IL28B genotype .
RESULTS	SVR12 rates were 78 % ( A1 ) , 65 % ( A2 ) , 95 % ( B1 ) , and 95 % ( B2 ) .
RESULTS	In B3 , most genotype 1a patients experienced virologic breakthrough .
RESULTS	The most common adverse events were headache , diarrhea , and asthenia .
RESULTS	Grade 3-4 aminotransferase elevations were infrequent and not treatment-limiting .
CONCLUSIONS	In genotype 1 null responders , daclatasvir plus twice-daily asunaprevir DUAL therapy is effective for most genotype 1b patients , and daclatasvir , asunaprevir , and PegIFN/RBV QUAD therapy is effective for nearly all genotype 1a and 1b patients ; but neither DUAL nor TRIPLE therapy is effective for genotype 1a patients .
CONCLUSIONS	Interferon-free regimens including daclatasvir and twice-daily asunaprevir for genotype 1 null responders should be tailored to subtype .

###24721435
BACKGROUND	The high-risk strategy has been proven effective in preventing cardiovascular disease ; however , the population benefits from these interventions remain unknown .
BACKGROUND	This study aims to assess , at the population level , the effects of an evidence-based high cardiovascular risk management program delivered by village doctors in rural China .
METHODS	The study will employ a cluster-randomized controlled trial in which a total of 120 villages in five northern provinces of China , will be assigned to either intervention ( 60 villages ) or control ( 60 villages ) .
METHODS	Village doctors in intervention villages will be trained to implement a simple evidence-based management program designed to identify , treat and follow-up as many as possible individuals at high-risk of cardiovascular disease in the village .
METHODS	The intervention will also include performance feedback as well as a performance-based incentive payment scheme and will last for 2 years .
METHODS	We will draw two different ( independent ) random samples , before and after the intervention , 20 men aged50 years and 20 women aged60 years from each village in each sample and a total of 9,600 participants from 2 samples to measure the study outcomes at the population level .
METHODS	The primary outcome will be the pre-post difference in mean systolic blood pressure , analyzed with a generalized estimating equations extension of linear regression model to account for cluster effect .
METHODS	Secondary outcomes will include monthly clinic visits , provision of lifestyle advice , use of antihypertensive medications and use of aspirin .
METHODS	Process and economic evaluations will also be conducted .
CONCLUSIONS	This trial will be the first implementation trial in the world to evaluate the population impact of the high-risk strategy in prevention and control of cardiovascular disease .
CONCLUSIONS	The results are expected to provide important information ( effectiveness , cost-effectiveness , feasibility and acceptability ) to guide policy making for rural China as well as other resource-limited countries .
BACKGROUND	The trial is registered at ClinicalTrials.gov ( NCT01259700 ) .
BACKGROUND	Date of initial registration is December 13 , 2010 .

###25293368
BACKGROUND	This phase 2/3 , randomized , placebo-controlled , observer-blinded study assessed the immunogenicity , reactogenicity , and safety of an inactivated , split-virion H5N1 influenza vaccine ( A/Indonesia/5 / 2005 ) in children aged 6 months through 17 years .
METHODS	Children received 2 influenza vaccine doses 21 days apart , each containing 1.9 g of hemagglutinin and AS03B adjuvant ( 5.93 mg of - tocopherol ) .
METHODS	The randomization ratio was 8:3 for vaccine to placebo , with equal allocation between 3 age strata ( 6-35 months , 3-8 years , and 9-17 years ) .
METHODS	Immunogenicity against the vaccine strain was assessed 21 days after the first and second vaccine doses for all vaccinees , at day 182 for half , and at day 385 for the remaining half .
METHODS	Reactogenicity after each dose and safety up to 1 year after vaccination were evaluated .
RESULTS	Within each age stratum , the lower limit of the 98.3 % confidence interval for the day 42 seroprotection rate was 70 % , thus fulfilling the US and European licensure criteria .
RESULTS	The immune responses elicited by vaccine persisted well above baseline levels for 1 year .
RESULTS	The vaccine was more reactogenic than placebo , but no major safety concerns were identified .
CONCLUSIONS	AS03B-adjuvanted H5N1 influenza vaccine was immunogenic and showed an acceptable safety profile in all age groups studied .
CONCLUSIONS	Clinical Trials Registration : NCT01310413 .

###25361054
BACKGROUND	The effect of eating speed at a meal on appetite gut hormone responses and future food consumption is not clear .
BACKGROUND	This study examined the effect of eating speed at breakfast on postprandial gut hormone responses , subjective appetite , and daily food consumption .
METHODS	Twenty-five participants [ 68 % men ; age , 25.9 ( 8.1 ) years ; body mass index , 25.0 ( 3.2 ) kg/m ] were recruited .
METHODS	Each participant consumed the same breakfast at a slow ( 30 minutes ) and fast ( 10 minutes ) speed , on 2 separate days , in a randomized crossover design .
METHODS	Blood samples were collected in the fasting state and 3 hours postprandially during each eating condition .
METHODS	Appetite was assessed over the same period using visual analog scales .
METHODS	Blood concentrations of orexigenic hormone , ghrelin , and anorexigenic hormones , glucagon-like peptide-1 ( GLP-1 ) and peptide YY ( PYY ) , were determined .
METHODS	Daily food intake was measured , by food recall , after the slow and fast breakfast .
RESULTS	Mixed-model repeated-measures analysis showed no eating condition or eating condition by time interaction effect on ghrelin , GLP-1 , PYY , hunger , or fullness .
RESULTS	Significant eating speed by time interaction effect on desire to eat was found ( P = 0.007 ) .
RESULTS	Desire to eat was lower at 60 minutes ( P = 0.007 ) after breakfast began during the slow versus fast eating condition .
RESULTS	Eating speed at breakfast did not affect daily energy and macronutrient intake .
CONCLUSIONS	Eating speed at breakfast did not affect postprandial ghrelin , GLP-1 , PYY , hunger , and fullness values or daily energy and macronutrient intake .
CONCLUSIONS	Desire to eat was lower at 60 minutes in the slow versus fast eating condition , but this result could not be explained by the changes in meal-related hormones measured in the study .

###24595632
OBJECTIVE	The conventional diet approach to gestational diabetes mellitus ( GDM ) advocates carbohydrate restriction , resulting in higher fat ( HF ) , also a substrate for fetal fat accretion and associated with maternal insulin resistance .
OBJECTIVE	Consequently , there is no consensus about the ideal GDM diet .
OBJECTIVE	We hypothesized that , compared with a conventional , lower-carbohydrate/HF diet ( 40 % carbohydrate/45 % fat/15 % protein ) , consumption of a higher-complex carbohydrate ( HCC ) / lower-fat ( LF ) Choosing Healthy Options in Carbohydrate Energy ( CHOICE ) diet ( 60/25/15 % ) would result in 24-h glucose area under the curve ( AUC ) profiles within therapeutic targets and lower postprandial lipids .
METHODS	Using a randomized , crossover design , we provided 16 GDM women ( BMI 34 1 kg/m2 ) with two 3-day isocaloric diets at 31 0.5 weeks ( washout between diets ) and performed continuous glucose monitoring .
METHODS	On day 4 of each diet , we determined postprandial ( 5 h ) glucose , insulin , triglycerides ( TGs ) , and free fatty acids ( FFAs ) following a controlled breakfast meal .
RESULTS	There were no between-diet differences for fasting or mean nocturnal glucose , but 24-h AUC was slightly higher ( 6 % ) on the HCC/LF CHOICE diet ( P = 0.02 ) .
RESULTS	The continuous glucose monitoring system ( CGMS ) revealed modestly higher 1 - and 2-h postprandial glucose on CHOICE ( 1 h , 115 2 vs. 107 3 mg/dL , P 0.01 ; 2 h , 106 3 vs. 97 3 mg/dL , P = 0.001 ) but well below current targets .
RESULTS	After breakfast , 5-h glucose and insulin AUCs were slightly higher ( P < 0.05 ) , TG AUC was no different , but the FFA AUC was significantly lower ( 19 % ; P 0.01 ) on the CHOICE diet .
CONCLUSIONS	This highly controlled study randomizing isocaloric diets and using a CGMS is the first to show that liberalizing complex carbohydrates and reducing fat still achieved glycemia below current treatment targets and lower postprandial FFAs .
CONCLUSIONS	This diet strategy may have important implications for preventing macrosomia .

###25220877
OBJECTIVE	This study evaluated the impact of blood sampling via peripheral arterial catheters on cerebral oxygenation and blood volume as a function of blood sampling velocity .
METHODS	Near-infrared spectroscopy was applied to 20 very low-birthweight infants during peripheral arterial blood sampling .
METHODS	Changes in cerebral oxygenated , deoxygenated and total haemoglobin , cerebral blood volume and cerebral oxygenation index were recorded .
METHODS	Heart rate and oxygen saturation were measured continuously .
METHODS	To assess the impact of blood sampling velocity , both fast 40-sec and slow 70-sec sampling procedures were performed in a crossover study design , in which the order of sampling velocities was randomised for each patient .
RESULTS	Both fast and slow blood sampling procedures resulted in a significant decrease in cerebral oxygenation index ( fast , p = 0.002 , slow , p = 0.008 ) , and an increase in mean heart rate ( both p = 0.02 ) and mean blood pressure ( p = 0.02 and 0.04 ) .
RESULTS	Oxygenated and total haemoglobin and cerebral blood volume only decreased significantly after slow blood sampling ( p < 0.001 ) .
CONCLUSIONS	Blood sampling from peripheral arterial catheters leads to significant fluctuations in cerebral oxygenation independent of the sampling velocity .
CONCLUSIONS	Changes are comparable to those reported from umbilical blood sampling .
CONCLUSIONS	We advise that blood sampling should be restricted as much as possible .

###25669003
BACKGROUND	Unilateral spinal anesthesia is performed to provide restriction of sensory and motor block .
OBJECTIVE	The aim of this study was to compare unilateral and bilateral spinal anesthesia , with regard to limiting the nerve block exclusively to the area of surgery .
METHODS	This was a prospective , randomised , double-blind study , conducted in 40 consecutive outpatients scheduled for unilateral inguinal regional surgery .
METHODS	Patients in both groups received 0.5 % hyperbaric bupivacaine 15 mg + morphine 0.1 mg .
METHODS	Patients in the unilateral group ( Group U ) were placed in the lateral decubitus position for 10 minutes ( min ) on their side to be operated , while patients in the bilateral group ( Group B ) were placed in the supine position .
METHODS	The pin-prick test was used to assess the times to reach L1 , T12 and T10 sensory blocks and the times to reach motor block .
METHODS	In addition , the sensory and motor block recovery times were recorded using a modified Bromage scale .
METHODS	Furthermore , the duration of the operation and the times to first analgesic requirement were noted .
RESULTS	There were significant differences between Group U and Group B in the times to reach L1 , T12 and T10 dermatome levels of sensory block , and the times to reach motor block using the modified Bromage scale on three levels .
RESULTS	However , there was no difference in the time to ambulation , the time to complete sensory regression and the time to first analgesic requirement .
CONCLUSIONS	The time to reach sensory and motor blocks for unilateral spinal anesthesia could provide an advantage over bilateral spinal anesthesia in inguinal region operations .

###25715865
OBJECTIVE	The objectives were to describe the frequency of repeat enrollment within a specific exception from informed consent trial testing benzodiazepine treatment of prehospital status epilepticus and to estimate the effect of repeat enrollments on the analysis of the primary outcome .
METHODS	This was a secondary analysis of data collected as part of the Rapid Anticonvulsant Medication Prior to Arrival Trial ( RAMPART ) , a study comparing intramuscular midazolam to intravenous lorazepam given by paramedics to patients with prehospital status epilepticus .
METHODS	Subjects in RAMPART achieved a successful primary outcome if they had cessation of seizures by the time of emergency department arrival .
METHODS	Data were collected on all subjects , but only the first enrollment for each individual was used in the primary analysis .
METHODS	The patterns of repeat enrollment are described , along with the demographics of these subjects .
METHODS	In addition , an intraclass correlation coefficient ( ICC ) was estimated to assess the amount of within-subject correlation and its effect on the estimated treatment effect when all enrollments are included in the analysis .
RESULTS	A total of 1,023 enrollments occurred in RAMPART among 893 unique individuals ( range of repeat enrollment observed = two to 14 ) .
RESULTS	The ICC for seizure cessation within individual was low at 0.119 ; when excluding subjects with benzodiazepine crossover , the ICC was 0.094 .
CONCLUSIONS	In clinical trials of emergency conditions with interval complete resolution , accounting for repeat enrollments is feasible .
CONCLUSIONS	The RAMPART experience demonstrated that in this setting the within-subject correlation is low and can be accounted for at relatively low statistical cost .

###24359500
BACKGROUND	Histaminergic H3 receptors may play a role in modulating cholinergic and monoaminergic neurotransmission .
BACKGROUND	This Phase II study evaluated the efficacy and safety of GSK239512 , a highly potent , brain penetrant H3 receptor antagonist as monotherapy treatment for subjects with mild-to-moderate probable Alzheimer 's disease ( AD ) .
METHODS	In this 16-week , double-blind , randomized , parallel group study , 196 currently untreated subjects with mild-tomoderate AD ( Mini Mental State Examination [ MMSE ] 16-24 ) received GSK239512 ( n = 97 ) ; or placebo ( n = 99 ) administered orally each morning .
METHODS	After a two-week placebo run-in period GSK239512 was up-titrated over 4 weeks in a flexible manner ( 10-20-40-80 microgram [ g ] ) followed by a 12-week Maintenance Phase .
METHODS	Co-primary efficacy endpoints were change from baseline in Episodic Memory and Executive Function/Working Memory composite scores from the CogState neuropsychological test battery ( NTB ) at Week 16 .
RESULTS	Compared to placebo , GSK239512 improved Episodic Memory at Week 16 ( Effect Size [ ES ] = 0.35 ; p = 0.0495 ) .
RESULTS	No statistically significant differences were observed on other cognitive domains or on clinical measures including the Alzheimer 's Disease Assessment Scale-Cognitive Subscale ( ADASCog ) .
RESULTS	GSK239512 treatment was associated with mild to moderate adverse events with headache , dizziness and events related to sleep disturbances being the most common and more pronounced in the early titration period when subjects were first being exposed to GSK239512 at the lower 10g and 20g doses .
RESULTS	There were no clinically relevant changes in other safety parameters .
CONCLUSIONS	GSK239512 , at doses up to 80g/day , improved Episodic Memory in patients with mildto - moderate AD .
CONCLUSIONS	However , no improvements were observed on Executive Function/Working Memory or other domains of cognition .
CONCLUSIONS	No changes were observed on any of the clinical measures included as secondary endpoints ( including ADAS-Cog ) indicating that GSK239512 failed to show benefit in this population .
CONCLUSIONS	GSK239512 had an acceptable safety and tolerability profile .
CONCLUSIONS	These findings suggest that H3 antagonists may , at most , have modest and selective effects on cognitive function in patients with mild-to-moderate AD .

###24687355
BACKGROUND	Infant formulae are being supplemented with probiotics , prebiotics , or symbiotic despite uncertainties regarding their efficacy .
BACKGROUND	Mexican agave is an interesting source of fructans with particular features and with potential prebiotic effects .
METHODS	RCT in 600 healthy term babies ( 20 7 days ) , allocated to receive standard infant formula ( control ) or infant formula added with a dual prebiotic system `` Metlin and Metlos '' , from Mexican agave .
METHODS	Primary outcomes include stools frequency , stools consistency , gastrointestinal intolerance ( frequency of abdominal distension , flatulency , regurgitations , vomiting ) .
METHODS	Secondary outcomes include changes on weight and height along the study and frequency of dermatologic problems ( eczema ) .
RESULTS	In 66,120 days of total follow-up , there were no differences on the frequency of stools passage ( Human Milk : 3.8 2.4 evacuations per day ; Pro + Metlin + Metlos 3.6 2.0 ; Pro + Metlin 3.6 2 ; only Pro 3.4 2.3 only formula 3.4 2.0 ; p NS ) .
RESULTS	Consistency of stools was similar between human milk and prebiotics supplemented groups .
RESULTS	Also the frequency of gastrointestinal symptoms was significantly low between these groups .
CONCLUSIONS	Fructans derivate from agave and added to infant formula are safe and well tolerated by Mexican healthy term babies .

###25137036
OBJECTIVE	This study evaluated the effect of resveratrol administration on metabolic syndrome , insulin sensitivity , and insulin secretion .
METHODS	A randomized , double-blind , placebo-controlled clinical trial was carried out in 24 patients with diagnosis of metabolic syndrome in accordance with the International Diabetes Federation criteria .
METHODS	Glucose and insulin levels were measured after a 75-gram dextrose load .
METHODS	Triglycerides and high-density lipoprotein cholesterol concentrations at baseline were also evaluated .
METHODS	Twelve patients received trans-resveratrol ( 500mg ) three times per day before meals for 90 days .
METHODS	The remaining 12 patients received placebo at the same dose .
METHODS	The area under the curve ( AUC ) values of glucose and insulin , total insulin secretion , first-phase of insulin secretion , and insulin sensitivity were calculated .
RESULTS	After resveratrol administration , there were significant differences in total weight ( 94.413.2 vs. 90.512.3 kg , P = 0.007 ) , body mass index ( BMI ) ( 35.63.2 vs. 34.33.0 kg/m ( 2 ) , P = 0.006 ) , fat mass ( 41.27.9 vs. 38.86.0 kg , P = 0.001 ) , and waist circumference ( WC ) ( 1099 vs. 10510cm , P = 0.004 ) .
RESULTS	There were also significant differences in AUC of insulin ( 48,41822,707 vs. 26,4738,273 pmol/L , P = 0.003 ) and insulinogenic index ( 0.480.22 vs. 0.280.08 , P = 0.004 ) .
CONCLUSIONS	Administration of resveratrol significantly decreases weight , BMI , fat mass , WC , AUC of insulin , and total insulin secretion .

###26051236
BACKGROUND	Most patients with non-small-cell lung cancer tumours that have EGFR mutations have deletion mutations in exon 19 or the Leu858Arg point mutation in exon 21 , or both ( ie , common mutations ) .
BACKGROUND	However , a subset of patients ( 10 % ) with mutations in EGFR have tumours that harbour uncommon mutations .
BACKGROUND	There is a paucity of data regarding the sensitivity of these tumours to EGFR inhibitors .
BACKGROUND	Here we present data for the activity of afatinib in patients with advanced non-small-cell lung cancer that have tumours harbouring uncommon EGFR mutations .
METHODS	In this post-hoc analysis , we used prospectively collected data from tyrosine kinase inhibitor-naive patients with EGFR mutation-positive advanced ( stage IIIb-IV ) lung adenocarcinomas who were given afatinib in a single group phase 2 trial ( LUX-Lung 2 ) , and randomised phase 3 trials ( LUX-Lung 3 and LUX-Lung 6 ) .
METHODS	Analyses were done in the intention-to-treat population , including all randomly assigned patients with uncommon EGFR mutations .
METHODS	The type of EGFR mutation ( exon 19 deletion [ del19 ] , Leu858Arg point mutation in exon 21 , or other ) and ethnic origin ( LUX-Lung 3 only ; Asian vs non-Asian ) were pre-specified stratification factors in the randomised trials .
METHODS	We categorised all uncommon mutations as : point mutations or duplications in exons 18-21 ( group 1 ) ; de-novo Thr790Met mutations in exon 20 alone or in combination with other mutations ( group 2 ) ; or exon 20 insertions ( group 3 ) .
METHODS	We also assessed outcomes in patients with the most frequent uncommon mutations , Gly719Xaa , Leu861Gln , and Ser768Ile , alone or in combination with other mutations .
METHODS	Response was established by independent radiological review .
METHODS	These trials are registered with ClinicalTrials.gov , numbers NCT00525148 , NCT00949650 , and NCT01121393 .
RESULTS	Of 600 patients given afatinib across the three trials , 75 ( 12 % ) patients had uncommon EGFR mutations ( 38 in group 1 , 14 in group 2 , 23 in group 3 ) .
RESULTS	27 ( 711 % , 95 % CI 541-846 ) patients in group 1 had objective responses , as did two ( 143 % , 18-428 ) in group 2 and two ( 87 % , 11-280 ) in group 3 .
RESULTS	Median progression-free survival was 107 months ( 95 % CI 56-147 ) in group 1 , 29 months ( 12-83 ) in group 2 ; and 27 months ( 18-42 ) in group 3 .
RESULTS	Median overall survival was 194 months ( 95 % CI 164-269 ) in group 1 , 149 months ( 81-249 ) in group 2 , and 92 months ( 41-142 ) in group 3 .
RESULTS	For the most frequent uncommon mutations , 14 ( 778 % , 95 % CI 524-936 ) patients with Gly719Xaa had an objective response , as did nine ( 563 % , 299-802 ) with Leu861Gln , and eight ( 1000 % , 631-1000 ) with Ser768Ile .
CONCLUSIONS	Afatinib was active in non-small-cell lung cancer tumours that harboured certain types of uncommon EGFR mutations , especially Gly719Xaa , Leu861Gln , and Ser768Ile , but less active in other mutations types .
CONCLUSIONS	Clinical benefit was lower in patients with de-novo Thr790Met and exon 20 insertion mutations .
CONCLUSIONS	These data could help inform clinical decisions for patients with non-small-cell lung cancer harbouring uncommon EGFR mutations .
BACKGROUND	Boehringer Ingelheim .

###25363186
BACKGROUND	Recent studies found omega-3 fatty acid deficiency in brain cell membranes of schizophrenic patients .
BACKGROUND	Conventional antipsychotics have many adverse reactions .
BACKGROUND	Safety , availability and low price made omega-3 as a potential supplement for treatment of these patients .
BACKGROUND	This study investigated the efficacy of omega-3 fatty acid as add-on treatment in schizophrenia .
METHODS	A randomized , double blind , placebo controlled fixed-dose , add-on clinical trial conducted over 8 weeks .
METHODS	60 patients with documented schizophrenia randomly divided into two groups : omega-3 ( 1000 mg/day ) ( n = 30 ) and placebo ( n = 30 ) .
METHODS	Patients received omega-3 or placebo in addition to their standard antipsychotic treatment .
METHODS	Patient follow up was done using Positive and Negative syndrome Scale ( PANSS ) .
METHODS	Data analyzed using SPSS software v. 20 .
RESULTS	At the end of 8 weeks treatment , PANSS score decreased significantly in both groups ( p < 0.05 ) in comparison to baseline .
RESULTS	Efficacy of omega-3 in decreasing general psychopathologic and total scores was significant in comparison to placebo group from 4 and 6 weeks after onset of treatment , respectively ( p < 0.05 ) .
RESULTS	Totally , omega-3 supplement therapy efficacy in comparison to sole conventional antipsychotics was 0.86 which was not significant ( p > 0.05 ) .
CONCLUSIONS	we found that supplemental omega-3 might increase efficacy of conventional antipsychotics in decreasing symptoms of schizophrenia .
CONCLUSIONS	Low price , rare adverse reactions and availability of omega-3 made this substance a potential supplement in improved treatment of schizophrenia

###24644139
OBJECTIVE	To evaluate the effects of caffeinated energy shots compared with noncaffeinated energy shots as assessed by changes in peripheral and central hemodynamic parameters in healthy subjects .
METHODS	Randomized , double-blind , controlled crossover study .
METHODS	University campus .
METHODS	Ten healthy volunteers .
RESULTS	Subjects were randomized to receive either a caffeinated or noncaffeinated energy shot ; after a minimum 6 days washout period , subjects were given the alternate energy shot .
RESULTS	Peripheral blood pressures , and central hemodynamic parameters , were assessed and recorded for each subject at baseline and at 1 and 3 hours after consumption of the energy shots .
RESULTS	Peripheral systolic blood pressure ( SBP ) increased significantly with the caffeinated energy shot compared with noncaffeinated ( 8.30 4.19 mm Hg and -0.20 5.55 , respectively , p = 0.009 ) at 3 hours .
RESULTS	Central SBP increased significantly with the caffeinated energy shot compared with noncaffeinated ( 8.00 4.03 mm Hg and 1.50 6.57 , respectively , p = 0.045 ) at 3 hours .
RESULTS	Peripheral and central diastolic blood pressure were nonsignificantly higher with the caffeinated energy shot at 3 hours .
RESULTS	Peripheral and central pulse pressure were consistently higher with consumption of the caffeinated beverage .
RESULTS	Heart rate , augmentation index , pulse pressure amplification ratio , ejection duration and Subendocardial Viability Ratio were not different between the two interventions over time .
RESULTS	P1 height was significantly higher with the caffeinated shot compared with the noncaffeinated shot at both 1 and 3 hours ( p = 0.035 and 0.013 , respectively ) .
RESULTS	Three and one subjects experienced an adverse effect with the caffeinated and noncaffeinated shot , respectively .
CONCLUSIONS	A caffeinated energy shot acutely increases peripheral and central SBPs compared with a noncaffeinated energy shot .
CONCLUSIONS	Larger studies with a placebo comparator are needed to assess the significance of peripheral and central hemodynamic changes with noncaffeinated energy drinks .

###25380092
BACKGROUND	Xanthelasma palpebrarum ( XP ) is a common cosmetic concern .
BACKGROUND	Although there is a wide range of therapeutic modalities for XP , there is no general consensus on the optimal treatment for such condition .
OBJECTIVE	Compare the efficacy and safety of super pulsed ( SP ) and fractional CO2 lasers in the treatment of XP .
METHODS	This prospective randomized comparative clinical study included 20 adult patients with bilateral and symmetrical XP lesions .
METHODS	Xanthelasma palpebrarum lesions were randomly assigned to treatment by either single session of ablative SP CO2 laser or 3 to 5 sessions of ablative fractional CO2 laser with monthly intervals .
METHODS	All patients were assessed using digital photography and optical coherence tomography images .
RESULTS	Xanthelasma palpebrarum lesions on both sides were successfully removed with significant improvement in size , color , and thickness .
RESULTS	Although lesions treated by SP CO2 laser showed significantly better improvement regarding color and thickness of the lesions , downtime and patient satisfaction were significantly better for lesions treated with fractional CO2 laser .
RESULTS	Scarring and recurrence were significantly higher in lesions treated by SP CO2 laser .
CONCLUSIONS	Ablative fractional CO2 laser is an effective and safe therapeutic option for XP with significantly shorter downtime and higher patient satisfaction compared with SP CO2 laser .

###25283757
BACKGROUND	Orally anticoagulated patients with insufficient knowledge about their treatment have a higher risk of complications .
BACKGROUND	Standardized patient education could raise their level of knowledge and improve time spent within target INR range .
METHODS	This cluster randomized trial included 319 anticoagulated patients drawn from 22 general medical practices .
METHODS	185 patients received patient education , conducted by practice nurses , consisting of a video , a brochure , and a questionnaire ; 134 control patients received only the brochure .
METHODS	The primary endpoint was knowledge about treatment six months after the patient education session .
METHODS	The secondary endpoints were time in the INR ( international normalized ratio ) target range and complications of anticoagulation .
RESULTS	Patients in the intervention and control groups were of comparable mean age ( 73 vs. 72 years ) .
RESULTS	They answered a comparable number of questions correctly before the intervention ( 6.8 0.2 vs. 6.7 0.2 ) but differed significantly on this measure at six months ( 9.9 0.2 vs. 7.6 0.2 , mean difference 2.3 questions , 95 % confidence interval [ CI ] 1.5-3 .1 , p < 0.001 ) .
RESULTS	In the six months prior to the intervention , the INR was in the target range 65 2 % vs. 66 3 % of the time ; in the six months afterward , 71 1 % vs. 64 3 % of the time ( mean difference 7 percentage points , 95 % CI -2 to -16 percentage points , p = 0.11 ) .
RESULTS	The complication rates were comparable in the two groups ( 12 % vs. 16 % , p = 0.30 ) .
RESULTS	Patients in the intervention group approved of patient education sessions to a greater extent than control patients ( 87 % vs. 56 % ) .
CONCLUSIONS	Patient education was found to be practical , to improve knowledge relating to patient safety in a durable manner , and to meet with the approval of the patients who received it .
CONCLUSIONS	There was a statistically non-significant trend toward an improvement of the time spent in the INR target range .
CONCLUSIONS	In view of the major knowledge deficits of orally anticoagulated patients , standardized patient education ought to be made a part of their routine care .

###25651245
BACKGROUND	Reproductive-age women need effective interventions to prevent the acquisition of human immunodeficiency virus type 1 ( HIV-1 ) infection .
METHODS	We conducted a randomized , placebo-controlled trial to assess daily treatment with oral tenofovir disoproxil fumarate ( TDF ) , oral tenofovir-emtricitabine ( TDF-FTC ) , or 1 % tenofovir ( TFV ) vaginal gel as preexposure prophylaxis against HIV-1 infection in women in South Africa , Uganda , and Zimbabwe .
METHODS	HIV-1 testing was performed monthly , and plasma TFV levels were assessed quarterly .
RESULTS	Of 12,320 women who were screened , 5029 were enrolled in the study .
RESULTS	The rate of retention in the study was 91 % during 5509 person-years of follow-up .
RESULTS	A total of 312 HIV-1 infections occurred ; the incidence of HIV-1 infection was 5.7 per 100 person-years .
RESULTS	In the modified intention-to-treat analysis , the effectiveness was -49.0 % with TDF ( hazard ratio for infection , 1.49 ; 95 % confidence interval [ CI ] , 0.97 to 2.29 ) , -4.4 % with TDF-FTC ( hazard ratio , 1.04 ; 95 % CI , 0.73 to 1.49 ) , and 14.5 % with TFV gel ( hazard ratio , 0.85 ; 95 % CI , 0.61 to 1.21 ) .
RESULTS	In a random sample , TFV was detected in 30 % , 29 % , and 25 % of available plasma samples from participants randomly assigned to receive TDF , TDF-FTC , and TFV gel , respectively .
RESULTS	Independent predictors of TFV detection included being married , being older than 25 years of age , and being multiparous .
RESULTS	Detection of TFV in plasma was negatively associated with characteristics predictive of HIV-1 acquisition .
RESULTS	Elevations of serum creatinine levels were seen more frequently among participants randomly assigned to receive oral TDF-FTC than among those assigned to receive oral placebo ( 1.3 % vs. 0.2 % , P = 0.004 ) .
RESULTS	We observed no significant differences in the frequencies of other adverse events .
CONCLUSIONS	None of the drug regimens we evaluated reduced the rates of HIV-1 acquisition in an intention-to-treat analysis .
CONCLUSIONS	Adherence to study drugs was low .
CONCLUSIONS	( Funded by the National Institutes of Health ; VOICE ClinicalTrials.gov number , NCT00705679 . )

###24465443
BACKGROUND	Rifampicin and protease inhibitors are difficult to use concomitantly in patients with HIV-associated tuberculosis because of drug-drug interactions .
BACKGROUND	Rifabutin has been proposed as an alternative rifamycin , but there is concern that the current recommended dose is suboptimal .
BACKGROUND	The principal aim of this study was to compare bioavailability of two doses of rifabutin ( 150 mg three times per week and 150 mg daily ) in patients with HIV-associated tuberculosis who initiated lopinavir/ritonavir-based antiretroviral therapy in Vietnam .
BACKGROUND	Concentrations of lopinavir/ritonavir were also measured .
METHODS	This was a randomized , open-label , multi-dose , two-arm , cross-over trial , conducted in Vietnamese adults with HIV-associated tuberculosis in Ho Chi Minh City ( Clinical trial registry number NCT00651066 ) .
METHODS	Rifabutin pharmacokinetics were evaluated before and after the introduction of lopinavir/ritonavir - based antiretroviral therapy using patient randomization lists .
METHODS	Serial rifabutin and 25-O-desacetyl rifabutin concentrations were measured during a dose interval after 2 weeks of rifabutin 300 mg daily , after 3 weeks of rifabutin 150 mg daily with lopinavir/ritonavir and after 3 weeks of rifabutin 150 mg three times per week with lopinavir/ritonavir .
RESULTS	Sixteen and seventeen patients were respectively randomized to the two arms , and pharmacokinetic analysis carried out in 12 and 13 respectively .
RESULTS	Rifabutin 150 mg daily with lopinavir/ritonavir was associated with a 32 % mean increase in rifabutin average steady state concentration compared with rifabutin 300 mg alone .
RESULTS	In contrast , the rifabutin average steady state concentration decreased by 44 % when rifabutin was given at 150 mg three times per week with lopinavir/ritonavir .
RESULTS	With both dosing regimens , 2 - 5 fold increases of the 25-O-desacetyl - rifabutin metabolite were observed when rifabutin was given with lopinavir/ritonavir compared with rifabutin alone .
RESULTS	The different doses of rifabutin had no significant effect on lopinavir/ritonavir plasma concentrations .
CONCLUSIONS	Based on these findings , rifabutin 150 mg daily may be preferred when co-administered with lopinavir/ritonavir in patients with HIV-associated tuberculosis .
BACKGROUND	ClinicalTrials.gov NCT00651066 .

###25486131
OBJECTIVE	Weight loss after pharmacotherapy varies greatly .
OBJECTIVE	We aimed to examine associations of quantitative gastrointestinal and psychological traits with obesity , and to validate the ability of these traits to predict responses of obese individuals to pharmacotherapy .
METHODS	In a prospective study , we measured gastric emptying of solids and liquids , fasting and postprandial gastric volume , satiation by nutrient drink test ( volume to fullness and maximal tolerated volume ) , satiety after an ad libitum buffet meal , gastrointestinal hormones , and psychological traits in 328 normal-weight , overweight , or obese adults .
METHODS	We also analyzed data from 181 previously studied adults to assess associations betwecen a subset of traits with body mass index and waist circumference .
METHODS	Latent dimensions associated with overweight or obesity were appraised by principal component analyses .
METHODS	We performed a proof of concept , placebo-controlled trial of extended-release phentermine and topiramate in 24 patients to validate associations between quantitative traits and response to weight-loss therapy .
RESULTS	In the prospective study , obesity was associated with fasting gastric volume ( P = .03 ) , accelerated gastric emptying ( P < .001 for solids and P = .011 for liquids ) , lower postprandial levels of peptide tyrosine tyrosine ( P = .003 ) , and higher postprandial levels of glucagon-like peptide 1 ( P < .001 ) .
RESULTS	In a combined analysis of data from all studies , obesity was associated with higher volume to fullness ( n = 509 ; P = .038 ) and satiety with abnormal waist circumference ( n = 271 ; P = .016 ) .
RESULTS	Principal component analysis identified latent dimensions that accounted for approximately 81 % of the variation among overweight and obese subjects , including satiety or satiation ( 21 % ) , gastric motility ( 14 % ) , psychological factors ( 13 % ) , and gastric sensorimotor factors ( 11 % ) .
RESULTS	The combination of phentermine and topiramate caused significant weight loss , slowed gastric emptying , and decreased calorie intake ; weight loss in response to phentermine and topiramate was significantly associated with calorie intake at the prior satiety test .
CONCLUSIONS	Quantitative traits are associated with high body mass index ; they can distinguish obesity phenotypes and , in a proof of concept clinical trial , predicted response to pharmacotherapy for obesity .
CONCLUSIONS	ClinicalTrials.gov Number : NCT01834404 .

###25912520
BACKGROUND	Computer-based educational games present an opportunity for health education in school ; however , their feasibility in school settings and effectiveness in changing behavior are poorly understood .
OBJECTIVE	To evaluate the feasibility , acceptability , and effects of the Quest to Lava Mountain ( QTLM ) computer game on dietary behaviors , physical activity behaviors , and psychosocial factors among ethnically diverse children in Texas .
METHODS	Quasi-experimental group-randomized controlled trial conducted during the 2012-2013 school year .
METHODS	A total of 107 children in fourth and fifth grade consented .
METHODS	There was an attrition rate of 8.8 % with a final sample size of 44 children in three intervention schools , and a sample of 50 children in three comparison schools .
METHODS	Dietary intake was measured using two random 24-hour recalls , whereas child self-report surveys measured diet , physical activity , and psychosocial factors before and after the intervention .
METHODS	Process data on QTLM usability and back-end server data on QTLM exposure and progress achieved were collected .
METHODS	QTLM was implemented as part of the in-school or afterschool program .
METHODS	Recommended game exposure duration was 90 min/wk for 6 weeks .
METHODS	Analysis of covariance or logistic regression models evaluated effects of QTLM on diet , physical activity , and psychosocial factors .
METHODS	Post hoc exploratory analysis examined the changes before and after the intervention in outcome variables among children in the intervention group .
METHODS	Significance was set at P < 0.05 .
RESULTS	Children played an average of 274110 minutes ( approximately 4.6 hours ) of QTLM during the 6 weeks ( 51 % of recommended dosage ) .
RESULTS	Compared with the comparison group , children in the intervention group reported decreased sugar consumption ( P = 0.021 ) and higher nutrition/physical activity attitudes ( P = 0.041 ) pre - to postintervention .
RESULTS	There were no significant effects of QTLM on physical activity .
RESULTS	However , post hoc analysis showed that higher QTLM exposure and gaming progress was associated with increased frequency of physical activity ( P < 0.05 ) .
CONCLUSIONS	QTLM has some promising acceptability and initial effects on diet and physical activity behaviors among children in elementary school .

###25624131
BACKGROUND	House dust mite ( HDM ) allergy is associated with persistent allergic rhinitis ( AR ) and allergic asthma .
OBJECTIVE	To investigate the efficacy and safety of a SQ HDM sublingually administered immunotherapy tablet ( ALK , Hrsholm , Denmark ) in adults and adolescents with HDM respiratory allergic disease and report the AR results .
METHODS	Six hundred four subjects at least 14 years old with HDM AR and mild to moderate HDM allergic asthma were randomized 1:1:1:1 to double-blinded daily treatment with 1 , 3 , 6 SQ-HDM or placebo .
METHODS	End-of-treatment rhinoconjunctivitis symptoms and medication score were predefined extrapulmonary end points .
METHODS	A subgroup analysis was conducted post hoc in subjects with a total combined rhinitis score ( TCRS ) > 0 ( ie , with AR symptoms and/or AR medication use during the 4-week baseline period ) .
METHODS	The subgroup was comprised of 498 subjects ( 82 % ) .
RESULTS	In the subgroup , the absolute difference in end-of-treatment TCRS between 6 SQ-HDM and placebo was-0 .78 ( 95 % confidence interval-1 .47 to-0 .07 , relative difference 28.8 % , P = .0357 ) .
RESULTS	Furthermore , a significant difference was found for the total score of the Rhinitis Quality of Life Questionnaire with Standardized Activities RQLQ ( S ) and for the individual domains : activities , sleep , non-nose and non-eye symptoms , and nasal symptoms .
RESULTS	For the TCRS and Rhinitis Quality of Life Questionnaire score , a dose response was seen , with numerically lower , nonsignificant differences for 1 and 3 SQ-HDM .
RESULTS	The predefined analysis for the entire trial population showed no statistically significant difference between the placebo and actively treated groups .
RESULTS	No safety concerns were observed .
CONCLUSIONS	Efficacy in mild to severe AR of 6 SQ-HDM compared with placebo was demonstrated by statistically significant improvements in TCRS and Rhinitis Quality of Life Questionnaire score in subjects with AR present at baseline .
CONCLUSIONS	The treatment was well tolerated .
BACKGROUND	EudraCT , no 2006-001795-20 ; ClinicalTrials.gov , identifier NCT00389363 .

###25828193
OBJECTIVE	This study aimed to investigate the neuromuscular adaptation following a 5-week high frequency and low amplitude whole body vibration ( WBV ) exercise training .
METHODS	The study is a prospective , double blind , randomized controlled intervention design with a total of 19 subjects volunteered to participate in the study .
METHODS	They were randomly assigned either to WBV exercise training or control group .
METHODS	Both groups participated in a 5-week training program .
METHODS	The intervention group received WBV in semi-squat position on a device with an amplitude of 0.76 mm , frequency of 40Hz , and peak acceleration of 23.9 m/s2 .
METHODS	Each vibration training session consisted of 6 series of 60s on with 30s rest period in between .
METHODS	The control group underwent the same statically mini-squatting position without exposure to WBV .
METHODS	The effectiveness of the vibration program was evaluated by vertical jump test and the isokinetic knee extensor peak torque .
METHODS	The possible neural factors that contributed to the improved muscular performance were evaluated by the stretch induced knee jerk reflex .
RESULTS	WBV training significantly enhanced the isokinetic knee extensor peak torque performance .
RESULTS	Two-way mixed repeated measures analysis of variance revealed significant time effect of the changes in the peak torque ( P = 0.043 ) and the effect was significantly different between the intervention and control group ( P = 0.042 ) .
RESULTS	WBV did not affect vertical jump height , reflex latency of VL , EMGVL , and knee jerk angle .
CONCLUSIONS	The results of this study do not support the hypothesis that the improvement in the muscular performance when subjects exposed to WBV training is attributed by neuromuscular efficiency via modulation of the muscle spindle sensitivity .

###24402595
OBJECTIVE	To compare anatomical and patient-reported outcomes at 12 months postoperatively for women who had anterior compartment pelvic organ prolapse ( POP ) surgery using a repair augmented with porcine small intestine submucosa mesh ( Mesh Group ) compared with those who had a native tissue repair ( No Mesh Group ) .
METHODS	This was a randomized controlled trial with 12 months follow-up .
METHODS	The surgical procedure was identical in both groups except for the placement of intervening mesh .
METHODS	The primary outcome was anatomical `` cure '' ( Ba of -1 or less on Pelvic Organ Prolapse Quantification [ POP-Q ] ) .
METHODS	Secondary outcomes included POP-Q stage , patient-reported outcomes , and patient satisfaction .
METHODS	The study was powered to detect a 40 % difference at 80 % power ( = 0.05 ) .
RESULTS	Fifty-seven women were randomized ( 28 to Mesh Group , 29 to No Mesh Group ) .
RESULTS	Forty-five ( 79 % ) underwent concomitant surgery .
RESULTS	At the 12-month follow-up , 56 % ( 15/27 ) in the Mesh Group and 61 % ( 17/28 ) in the No Mesh Group were considered cured ( relative risk 0.90 , 95 % confidence interval 0.52-1 .54 ) .
RESULTS	There were no significant differences between groups in recurrent or persistent prolapse ( 7 % in each group ) nor in patient-reported outcomes at 12 months .
RESULTS	Pelvic girdle pain occurred in 4 of 27 in the Mesh Group and 3 of 28 in the No Mesh Group .
CONCLUSIONS	No significant differences were observed in anatomical or patient-reported outcomes outcome parameters at 12 months after correction of symptomatic anterior POP by mesh or no mesh repair .
CONCLUSIONS	In our study , porcine small intestine submucosa mesh did not confer additional benefit over a native tissue repair .
BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT0095544 .
BACKGROUND	LEVEL OF EVEDIENCE : I.

###25270886
BACKGROUND	Generalized Anxiety Disorder ( GAD ) is a high prevalence , chronic disorder .
BACKGROUND	Web-based interventions are acceptable , engaging , and can be delivered at scale .
BACKGROUND	Few randomized controlled trials evaluate the effectiveness of prevention programs for anxiety , or the factors that improve effectiveness and engagement .
OBJECTIVE	The intent of the study was to evaluate the effectiveness of a Web-based program in preventing GAD symptoms in young adults , and to determine the role of telephone and email reminders .
METHODS	A 5-arm randomized controlled trial with 558 Internet users in the community , recruited via the Australian Electoral Roll , was conducted with 6 - and 12-month follow-up .
METHODS	Five interventions were offered over a 10-week period .
METHODS	Group 1 ( Active website ) received a combined intervention of psycho-education , Internet-delivered Cognitive Behavioral Therapy ( ICBT ) for anxiety , physical activity promotion , and relaxation .
METHODS	Group 2 ( Active website with telephone ) received the identical Web program plus weekly telephone reminder calls .
METHODS	Group 3 ( Active website with email ) received the identical Web program plus weekly email reminders .
METHODS	Group 4 ( Control ) received a placebo website .
METHODS	Group 5 ( Control with telephone ) received the placebo website plus telephone calls .
METHODS	Main outcome measures were severity of anxiety symptoms as measured by the GAD 7-item scale ( GAD-7 ) ( at post-test , 6 , and 12 months ) .
METHODS	Secondary measures were GAD caseness , measured by the Mini International Neuropsychiatric Interview ( MINI ) at 6 months , Centre for Epidemiologic Studies-Depression scale ( CES-D ) , Anxiety Sensitivity Index ( ASI ) , Penn State Worry Questionnaire ( PSWQ ) , and Days out of Role .
RESULTS	GAD-7 symptoms reduced over post-test , 6-month , and 12-month follow-up .
RESULTS	There were no significant differences between Group 4 ( Control ) and Groups 1 ( Active website ) , 2 ( Active website with telephone ) , 3 ( Active website with email ) , or 5 ( Control with telephone ) at any follow-up .
RESULTS	A total of 16 cases of GAD were identified at 6 months , comprising 6.7 % ( 11/165 ) from the Active groups ( 1 , 2 , 3 ) and 4.5 % ( 5/110 ) from the Control groups ( 4 , 5 ) , a difference that was not significant .
RESULTS	CES-D , ASI , and PSWQ scores were significantly lower for the active website with email reminders at post-test , relative to the control website condition .
CONCLUSIONS	Indicated prevention of GAD was not effective in reducing anxiety levels , measured by GAD-7 .
CONCLUSIONS	There were significant secondary effects for anxiety sensitivity , worry , and depression .
CONCLUSIONS	Challenges for indicated prevention trials are discussed .
BACKGROUND	International Standard Randomized Controlled Trial Number ( ISRCTN ) : 76298775 ; http://www.controlled-trials.com/ISRCTN76298775 ( Archived by WebCite at http://www.webcitation.org/6S9aB5MAq ) .

###25617224
BACKGROUND	Low levels of vitamin D are associated with asthma severity , airway remodeling , and exacerbation rate increase , especially in nonatopic asthma .
BACKGROUND	Reduced steroid responsiveness or impaired antimicrobial defense might be underlying mechanisms .
OBJECTIVE	We sought to evaluate the effect of vitamin D supplementation on eosinophilic and neutrophilic airway inflammation in patients with nonatopic asthma .
METHODS	In a double-blind , randomized , placebo-controlled trial , we investigated the effect of long-acting vitamin D3 ( 400,000 IU ) on sputum neutrophils and eosinophils in 44 patients with nonatopic asthma with neutrophilic ( 53 % ) and/or eosinophilic ( 3 % ) airway inflammation .
METHODS	Sputum induction was performed at baseline and after 9 weeks .
METHODS	Other measurements included questionnaires , blood samples , and pulmonary function .
RESULTS	Treatment with vitamin D did not significantly affect sputum neutrophils or eosinophils compared with treatment with placebo in the total group .
RESULTS	Regarding sputum eosinophils , the effect of vitamin D appeared to be dependent on baseline sputum eosinophil levels ( interaction P = .015 ) .
RESULTS	In patients with eosinophil levels of 26.2 % or more ( median in patients with sputum eosinophilia , > 3 % ) , eosinophils decreased from a median of 41.0 % to 11.8 % after vitamin D treatment as compared with an increase from 51.8 % to 63.3 % in patients receiving placebo ( P = .034 ) .
RESULTS	Vitamin D treatment also resulted in slightly better Asthma Control Questionnaire scores ( P = .08 ) .
CONCLUSIONS	Vitamin D supplementation reduced eosinophilic airway inflammation in patients with nonatopic asthma with severe eosinophilic airway inflammation , but did not affect sputum neutrophils .
CONCLUSIONS	Also , a small effect on asthma control was observed .
CONCLUSIONS	These findings suggest that vitamin D might have potential as an add-on treatment option in eosinophilic asthma .

###24972963
BACKGROUND	To perform high-quality cardiopulmonary resuscitation ( CPR ) , high-quality chest compression and ventilation support should be performed .
BACKGROUND	However , many providers still have not maintained an adequate ventilation rate but hyperventilated during CPR .
BACKGROUND	Thus , this study was conducted to verify that the compression-adjusted ventilation ( CAV ) would be a more accurate ventilation method compared with the conventional ventilation ( CV ) .
METHODS	Volunteer medical students and emergency medical services personnel were recruited .
METHODS	They were randomly divided into either the CV group or the CAV group .
METHODS	In the CV group , participants performed ventilation with estimation of the rate of 8 to 10 per minute ( 1 ventilation/6 -8 seconds ) .
METHODS	In the CAV group , the ventilation rate was adjusted in line with the compression rate ( compression : ventilation , 12:1 ) .
METHODS	In each group , 2-rescuer adult CPR was performed on a manikin , which was intubated with an endotracheal tube , during a period of 8 minutes .
METHODS	The compression rate and the ventilation rate were recorded during CPR .
RESULTS	Data on 56 medical students and 41 emergency medical services personnel were analyzed .
RESULTS	No significant difference was observed in compression rate ( P = .817 ) ; however , median ( interquartile range ) ventilation rate differed significantly between the CV and CAV groups ( 8.79 [ 2.19 ] per minute vs 9.25 [ 1.07 ] per minute , P = .016 ) .
RESULTS	In addition , compared with the CV group , adequacy of ventilation rate was better in the CAV group ( 47.9 % vs 85.7 % , P < .001 ) .
CONCLUSIONS	In comparison with the CV , the CAV is a more accurate method for maintenance of an adequate ventilation rate .

###24756903
OBJECTIVE	To identify a molecular signature that could be predictive of the clinical response to rituximab ( RTX ) and elucidate the transcriptomic changes after RTX therapy in patients with rheumatoid arthritis ( RA ) , with the use of whole-blood transcriptomic profiling .
METHODS	A microarray assay of the whole human genome was performed using RNA from peripheral blood samples obtained before the first cycle of RTX from 68 patients with RA in the SMART study .
METHODS	The transcriptomic profile was also assessed 24 weeks after the first administration of RTX ( among 24 nonresponders and 44 responders , according to the European League Against Rheumatism response criteria at week 24 ) .
METHODS	Ingenuity Interactive Pathways Analysis was used to identify molecular pathways that were modified by RTX therapy according to the clinical response .
METHODS	Quantitative polymerase chain reaction was performed to confirm the microarray results .
RESULTS	In total , 198 genes showed significant baseline differential expression between patient groups according to their subsequent response to RTX ( good or moderate responder versus nonresponder ) .
RESULTS	This molecular signature could be reduced to 143 genes , which allowed for correctly classifying 89 % of the patients by their EULAR response status at week 24 , with 93 % identification of responders and 100 % identification of nonresponders .
RESULTS	The signature for response featured up-regulation of inflammatory genes centered on NF-B , including IL33 and STAT5A , and down-regulation of the interferon pathway .
RESULTS	As expected , at week 24 post-RTX therapy , genes involved in the development and functions of B cells were the genes most strongly down-regulated , without any difference between the 2 groups .
CONCLUSIONS	Whole-blood transcriptomic analyses may accurately identify patients with RA who will not respond to RTX therapy .
CONCLUSIONS	These findings could open new perspectives on the clinical management of RA .

###24708675
BACKGROUND	Existing data are not consistently supportive of improved clinical outcome when vancomycin dosing regimens aimed at achieving target trough levels are used .
BACKGROUND	A retrospective , post hoc , subgroup analysis of prospectively collected data from the Phase 3 ATTAIN trials of telavancin versus vancomycin for treatment of nosocomial pneumonia was conducted to further investigate the relationship between vancomycin serum trough levels and patient outcome .
METHODS	Study patients were enrolled in 274 study sites across 38 countries .
METHODS	A total of 98 patients had Staphylococcus aureus nosocomial pneumonia and vancomycin serum trough levels available .
METHODS	These patients were grouped according to their median vancomycin trough level ; < 10g/mL , 10g/mL to < 15g/mL , and15g/mL .
RESULTS	Clinical cure rates in the < 10g/mL , 10g/mL to < 15g/mL , and15g/mL vancomycin trough level groups were 70 % ( 21/30 ) , 55 % ( 18/33 ) , and 49 % ( 17/35 ) , respectively ( p = 0.09 ) , and the frequencies of patient death were 10 % ( 3/30 ) , 15 % ( 5/33 ) , and 20 % ( 7/35 ) , respectively ( p = 0.31 ) .
RESULTS	Renal adverse events were more frequent in the15g/mL ( 17 % [ 6/35 ] ) than the < 10g/mL ( 0 % ) and 10g/mL to < 15g/mL ( 3 % [ 1/33 ] ) trough level groups ( p < 0.01 ) .
RESULTS	When patients with acute renal failure or vancomycin exposure within 7days prior to study medication were excluded , clinical cure rates in the < 10g/mL , 10g/mL to < 15g/mL , and15g/mL vancomycin trough level groups ( 71 % [ 12/17 ] , 60 % [ 9/15 ] , and 27 % [ 3/11 ] , respectively ; p = 0.04 ) and the number of deaths ( 12 % [ 2/17 ] , 20 % [ 3/15 ] , and 45 % [ 5/11 ] , respectively ; p = 0.07 ) demonstrated a trend towards worse outcomes in the higher vancomycin trough level groups .
CONCLUSIONS	The findings of our study suggest that higher vancomycin trough levels do not result in improved clinical response but likely increase the incidence of nephrotoxicity .
BACKGROUND	NCT00107952 and NCT00124020 .

###24366034
OBJECTIVE	As evidence suggests visit-to-visit variability ( VVV ) of blood pressure ( BP ) is associated with cardiovascular events and mortality , there is increasing interest in identifying interventions that reduce VVV of BP .
OBJECTIVE	We investigated the effects of weight loss and sodium reduction , alone or in combination , on VVV of BP in participants enrolled in phase II of the Trials of Hypertension Prevention .
METHODS	BP readings were taken at 6-month intervals for 36 months in 1820 participants with high-normal DBP who were randomized to weight loss , sodium reduction , combination ( weight loss and sodium reduction ) , or usual care groups .
METHODS	VVV of BP was defined as the SD of BP across six follow-up visits .
RESULTS	VVV of SBP was not significantly different between participants randomized to the weight loss ( 7.23.1 mmHg ) , sodium reduction ( 7.13.0 mmHg ) , or combined ( 6.92.9 mmHg ) intervention groups vs. the usual care group ( 6.92.9 mmHg ) .
RESULTS	In a fully adjusted model , no difference ( 0.00.2 mmHg ) in VVV of SBP was present between individuals who successfully maintained their weight loss vs. individuals who did not lose weight during follow-up ( P = 0.93 ) .
RESULTS	Also , those who maintained a reduced sodium intake throughout follow-up did not have lower VVV of SBP compared to those who did not reduce their sodium intake ( 0.10.3 mmHg ; P = 0.77 ) .
RESULTS	Results were similar for VVV of DBP .
CONCLUSIONS	These findings suggest that weight loss and sodium reduction may not be effective interventions for lowering VVV of BP in individuals with high-normal DBP .

###24256848
BACKGROUND	Concurrent chemoradiotherapy ( CCRT ) is the standard treatment for patients with unresectable , nonmetastatic locoregionally advanced squamous-cell carcinoma of the head and neck ( LASCCHN ) .
BACKGROUND	This randomized , open-label , phase III clinical trial compared the efficacy between standard CCRT and two different induction chemotherapy ( ICT ) regimens followed by CCRT .
METHODS	Patients with untreated LASCCHN were randomly assigned to ICT ( three cycles ) , with either docetaxel ( Taxotere ) , cisplatin and 5-fluorouracil ( TPF arm ) or cisplatin and 5-fluorouracil ( PF arm ) , followed by CCRT [ 7 weeks of radiotherapy ( RT ) with cisplatin 100 mg/m ( 2 ) on days 1 , 22 and 43 ] ; or 7 weeks of CCRT alone .
METHODS	The primary end points were progression-free survival ( PFS ) and time-to-treatment failure ( TTF ) .
RESULTS	In the intention-to-treat ( ITT ) population ( n = 439 ) , the median PFS times were 14.6 ( 95 % CI , 11.6-20 .4 ) , 14.3 ( 95 % CI , 11.8-19 .3 ) and 13.8 months ( 95 % CI , 11.0-17 .5 ) at TPF-CCRT , PF-CCRT and CCRT arms , respectively ( log-rank P = 0.56 ) .
RESULTS	The median TTF were 7.9 ( 95 % CI , 5.9-11 .8 ) , 7.9 ( 95 % CI , 6.5-11 .8 ) and 8.2 months ( 95 % CI , 6.7-12 .6 ) for TPF-CCRT , PF-CCRT and CCRT alone , respectively ( log-rank P = 0.90 ) .
RESULTS	There were no statistically significant differences for overall survival ( OS ) .
RESULTS	Toxic effects from ICT-CCRT were manageable .
CONCLUSIONS	Overall , this trial failed to show any advantage of ICT-CCRT over CCRT alone in patients with unresectable LASCCHN .

###26043228
BACKGROUND	Recent studies indicate that glucagon-like peptide ( GLP ) -1 regulates bone turnover , but the effects of GLP-1 receptor agonists ( GLP-1 RAs ) on bone in obese weight-reduced individuals are unknown .
OBJECTIVE	To investigate the role of GLP-1 RAs on bone formation and weight loss-induced bone mass reduction .
METHODS	Randomized control study .
METHODS	Outpatient research hospital clinic .
METHODS	Thirty-seven healthy obese women with body mass index of 34 0.5 kg/m ( 2 ) and age 46 2 years .
METHODS	After a low-calorie-diet-induced 12 % weight loss , participants were randomized to treatment with or without administration of the GLP-1 RA liraglutide ( 1.2 mg/d ) for 52 weeks .
METHODS	In case of weight gain , up to two meals per day could be replaced with a low-calorie-diet product to maintain the weight loss .
METHODS	Total , pelvic , and arm-leg bone mineral content ( BMC ) and bone markers [ C-terminal telopeptide of type 1 collagen ( CTX-1 ) and N-terminal propeptide of type 1 procollagen ( P1NP ) ] were investigated before and after weight loss and after 52-week weight maintenance .
METHODS	Primary endpoints were changes in BMC and bone markers after 52-week weight maintenance with or without GLP-1 RA treatment .
RESULTS	Total , pelvic , and arm-leg BMC decreased during weight maintenance in the control group ( P < .0001 ) , but not significantly in the liraglutide group .
RESULTS	Thus , total and arm-leg BMC loss was four times greater in the control group compared to the liraglutide group ( estimated difference , 27 g ; 95 % confidence interval , 5-48 ; P = .01 ) , although the 12 % weight loss was maintained in both groups .
RESULTS	In the liraglutide group , the bone formation marker P1NP increased by 16 % ( 7 3 g/L ) vs a 2 % ( -1 4 g/L ) decrease in the control group ( P < .05 ) .
RESULTS	The bone resorption marker CTX-1 collagen did not change during the weight loss maintenance phase .
CONCLUSIONS	Treatment with a long-acting GLP-1 RA increased bone formation by 16 % and prevented bone loss after weight loss obtained through a low-calorie diet , supporting its role as a safe weight-lowering agent .

###24521675
OBJECTIVE	To assess the impact of domicile-based humidification on symptom burden during radiation therapy ( RT ) for head-and-neck ( H&N ) cancer .
METHODS	From June 2007 through June 2011 , 210 patients with H&N cancer receiving RT were randomized to either a control arm or to receive humidification using the Fisher & Paykel Healthcare MR880 humidifier .
METHODS	Humidification commenced on day 1 of RT and continued until Common Terminology Criteria for Adverse Events ( CTCAE ) , version 3.0 , clinical mucositis ( CMuc ) grade 1 occurred .
METHODS	Forty-three patients ( 42 % ) met a defined benchmark for humidification compliance and contributed to per protocol ( PP ) analysis .
METHODS	Acute toxicities , hospitalizations , and feeding tube events were recorded prospectively .
METHODS	The McMaster University Head and Neck Radiotherapy Questionnaire ( HNRQ ) was used for patient-reported outcomes .
METHODS	The primary endpoint was area under the curve ( AUC ) for CMuc grade 2 .
RESULTS	There were no significant differences in AUC for CMuc 2 between the 2 arms .
RESULTS	Humidification patients had significantly fewer days in hospital ( P = .017 ) .
RESULTS	In compliant PP patients , the AUC for CTCAE functional mucositis score ( FMuc ) 2 was significantly reduced ( P = .009 ) , and the proportion who never required a feeding tube was significantly greater ( P = .04 ) .
RESULTS	HNRQ PP analysis estimates also in the direction favoring humidification with less symptom severity , although differences at most time points did not reach significance .
CONCLUSIONS	TROG 07.03 has provided efficacy signals consistent with a role for humidification in reducing symptom burden from mucositis , but the influence of humidification compliance on the results moderates recommendations regarding its practical utility .

###24886606
BACKGROUND	New clinical research findings may require clinicians to change their behaviour to provide high-quality care to people with type 2 diabetes , likely requiring them to change multiple different clinical behaviours .
BACKGROUND	The present study builds on findings from a UK-wide study of theory-based behavioural and organisational factors associated with prescribing , advising , and examining consistent with high-quality diabetes care .
OBJECTIVE	To develop and evaluate the effectiveness and cost of an intervention to improve multiple behaviours in clinicians involved in delivering high-quality care for type 2 diabetes .
METHODS	We will conduct a two-armed cluster randomised controlled trial in 44 general practices in the North East of England to evaluate a theory-based behaviour change intervention .
METHODS	We will target improvement in six underperformed clinical behaviours highlighted in quality standards for type 2 diabetes : prescribing for hypertension ; prescribing for glycaemic control ; providing physical activity advice ; providing nutrition advice ; providing on-going education ; and ensuring that feet have been examined .
METHODS	The primary outcome will be the proportion of patients appropriately prescribed and examined ( using anonymised computer records ) , and advised ( using anonymous patient surveys ) at 12months .
METHODS	We will use behaviour change techniques targeting motivational , volitional , and impulsive factors that we have previously demonstrated to be predictive of multiple health professional behaviours involved in high-quality type 2 diabetes care .
METHODS	We will also investigate whether the intervention was delivered as designed ( fidelity ) by coding audiotaped workshops and interventionist delivery reports , and operated as hypothesised ( process evaluation ) by analysing responses to theory-based postal questionnaires .
METHODS	In addition , we will conduct post-trial qualitative interviews with practice teams to further inform the process evaluation , and a post-trial economic analysis to estimate the costs of the intervention and cost of service use .
CONCLUSIONS	Consistent with UK Medical Research Council guidance and building on previous development research , this pragmatic cluster randomised trial will evaluate the effectiveness of a theory-based complex intervention focusing on changing multiple clinical behaviours to improve quality of diabetes care .
BACKGROUND	ISRCTN66498413 .

###26281341
OBJECTIVE	To compare local infiltration anesthesia ( LIA ) and peripheral nerve block ( PNB ) in repairing hand lacerations .
METHODS	This prospective study was designed as a randomized , controlled , unblinded trial .
METHODS	Fifty four patients with hand lacerations were included in the study .
METHODS	While 23 of these patients had LIA , PNB was performed in the remaining 31 patients .
METHODS	Lidocaine hydrochloride 2 % and 27 gauge needles were used .
METHODS	Onset time of the anesthesia , response to the injection and suturing procedures , need for additional anesthetic , and patient satisfaction were compared .
RESULTS	No significant differences were noted between the groups in terms of response to injection pain and suture pain ( Mann-Whitney U ; P = 0.220 / P = 0.316 ) .
RESULTS	There were also no significant differences between the groups when patient satisfaction ( chi-square ; P = 0.785 ) and need for additional local anesthetics ( Fisher 's exact ; P = 0.628 ) were evaluated .
RESULTS	The time to loss of pinprick sensation in the local infiltration group was 1.3 min , whereas in the nerve block group it was 2.2 min .
RESULTS	The difference was statistically significant ( Mann-Whitney U ; P < 0.001 ) .
CONCLUSIONS	Despite the fact that performing PNB in emergency departments requires some experience , it still counts as a convenient method comparable to LIA .

###25147806
BACKGROUND	Primary goal of this randomized , double-blind , placebo-controlled crossover study of Renadyl in end-stage renal disease patients was to assess the safety and efficacy of Renadyl measured through improvement in quality of life or reduction in levels of known uremic toxins .
BACKGROUND	Secondary goal was to investigate the effects on several biomarkers of inflammation and oxidative stress .
METHODS	Two 2-month treatment periods separated by 2-month washout and crossover , with physical examinations , venous blood testing , and quality of life questionnaires completed at each visit .
METHODS	Data were analyzed with SAS V9 .2 .
RESULTS	22 subjects ( 79 % ) completed the study .
RESULTS	Observed trends were as follows ( none reaching statistical significance ) : decline in WBC count ( -0.51 10 ( 9 ) / L , P = 0.057 ) and reductions in levels of C-reactive protein ( -8.61 mg/L , P = 0.071 ) and total indoxyl glucuronide ( -0.11 mg % , P = 0.058 ) .
RESULTS	No statistically significant changes were observed in other uremic toxin levels or measures of QOL .
CONCLUSIONS	Renadyl appeared to be safe to administer to ESRD patients on hemodialysis .
CONCLUSIONS	Stability in QOL assessment is an encouraging result for a patient cohort in such advanced stage of kidney disease .
CONCLUSIONS	Efficacy could not be confirmed definitively , primarily due to small sample size and low statistical power-further studies are warranted .

###24671434
OBJECTIVE	Cancer-related fatigue is a multidimensional symptom with an underestimated prevalence and severity in cancer patients .
OBJECTIVE	The aim of the study was to evaluate the effect of dance as a holistic sportive activity in cancer patients under active anticancer treatment with fatigue as endpoint .
METHODS	Forty patients under active anticancer treatment ( adjuvant ( 25 ) , palliative ( 11 ) or neoadjuvant ( 4 ) ) with moderate or severe fatigue ( 4 on the visual analogue scale ) were investigated in two groups for severity of fatigue ( visual analogue scale , Functional Assessment of Chronic Illness Therapy : Fatigue questionnaire ) , quality of life ( European Organization for Research and Treatment of Cancer , Quality of Life Questionnaire ) and physical performance ( 6-minute walk test ) before and after the study period -- group A ( n = 20 ) : intervention ( 10 dance classes in 5 weeks in addition to counselling ) and group B ( n = 20 ) : control ( no dance , standard of care , counselling ) .
RESULTS	We found significant improvements for cancer-related fatigue in the intervention group ( baseline mean SD 5.95 1.701 , end-of-study mean 3.8 1.542 , p = 0.001 , reduction of 36 % ) compared to the control group ( baseline mean 4.95 0.999 , end-of-study mean unchanged at 5.0 1.556 , p = 0.887 ) ; as well as for emotional and social functioning scales and physical performance ( p < 0.05 ) .
CONCLUSIONS	Dance might be an appropriate , effective approach for treatment of cancer-related fatigue .

###25044172
BACKGROUND	Aphasia is a common and severely disabling complication in stroke patients .
BACKGROUND	It usually brings about lower rates of functional recovery , longer rehabilitation length of stay ( LOS ) , and significantly poorer LOS efficiency ( LOS-Eff ) , resulting in higher rehabilitation costs compared to patients without aphasia .
BACKGROUND	It also decreases the quality of life and increases the mortality of stroke patients .
BACKGROUND	The evidence currently available suggests that the effect of acupuncture combined with language training for apoplectic aphasia is statistically better than speech and language therapy ( SLT ) alone , but there remains a lack of high-quality randomized controlled trials .
BACKGROUND	Acupuncture combined with language training is relatively low-cost and especially suitable for community-based rehabilitation for aphasia patients after stroke , taking its medical and health facilities which are always deficient in manpower and material resources into account .
BACKGROUND	The aim of the present study is to develop an effective standard therapeutic program for apoplectic aphasia in communities .
METHODS	In a randomized controlled clinical trial with blinded assessment , 290 eligible patients with aphasia due to stroke will be randomly allocated into a control group or an experimental group .
METHODS	The course of this trial will comprise a 4-week intervention and a 12-week follow-up period .
METHODS	Five assessment points , including baseline , 2 and 4weeks after treatment , 6 and 12weeks after follow-up , are set to dynamically observe the changes of curative effects .
METHODS	Primary outcome measures are the differences in the score on both the China rehabilitation research center aphasia examination ( CRRCAE ) and Boston diagnostic aphasia examination - Chinese version ( BDAE-C ) after intervention and follow-up .
METHODS	The Modified Barthel Index ( MBI ) , 36-Item Short Form Health Survey ( SF-36 ) , and results of blood oxygen level dependent-functional magnetic resonance imaging ( BOLD-fMRI ) examination are considered as the secondary outcome measures .
METHODS	Other outcomes will include rate of adverse events and economic effects .
CONCLUSIONS	If the outcome is positive , this project will offer a low-cost appropriate technology for community health centers ( CHCs ) in the rehabilitation of aphasia patients after stroke , and could be implemented on a large scale , both in China and worldwide .
BACKGROUND	Chinese Clinical Trial Registry : ChiCTR-TRC-13003703 .
BACKGROUND	Registration date : 18 October 2013 .

###25896460
OBJECTIVE	To examine the relationship of choroidal thickness with axial length ( AL ) and myopia in young adult eyes in the ethnically diverse Correction of Myopia Evaluation Trial ( COMET ) cohort .
METHODS	Cross-sectional , multicenter study .
METHODS	In addition to measures of myopia by cycloplegic autorefraction and AL by A-scan ultrasonography , participants underwent optical coherence tomography imaging of the choroid in both eyes at their last visit ( 14 years after baseline ) .
METHODS	Using digital calipers , 2 independent readers measured choroidal thickness in the right eye ( left eye if poor quality ; n = 37 ) at 7 locations : fovea and 750 , 1500 , and 2250 m nasal ( N ) and temporal ( T ) to the fovea .
RESULTS	Choroidal thickness measurements were available from 294 of 346 ( 85 % ) imaged participants ( mean age : 24.3 1.4 years ; 44.9 % male ) with mean myopia of -5.3 2.0 diopters and mean AL of 25.5 1.0 mm .
RESULTS	Overall , choroidal thickness varied by location ( P < .0001 ) and was thickest at the fovea ( 273.8 70.9 m ) and thinnest nasally ( N2250 , 191.5 69.3 m ) .
RESULTS	Multivariable analyses showed significantly thinner choroids in eyes with more myopia and longer AL at all locations except T2250 ( P .001 ) and presence of peripapillary crescent at all locations except T1500 and T2250 ( P .0001 ) .
RESULTS	Choroidal thickness varied by ethnicity at N2250 ( P < .0001 ) , with Asians having the thinnest and African Americans the thickest choroids .
CONCLUSIONS	Choroids are thinner in longer , more myopic young adult eyes .
CONCLUSIONS	The thinning was most prominent nasally and in eyes with a crescent .
CONCLUSIONS	In the furthest nasal location , ethnicity was associated with choroidal thickness .
CONCLUSIONS	The findings suggest that choroidal thickness should be evaluated , especially in the nasal regions where myopic degenerations are most commonly seen clinically .

###24902921
BACKGROUND	Blinding is a fundamental design strengthening feature in randomized clinical trials .
BACKGROUND	Blinding is particularly important in trials whose outcome measures include subjective assessment of signs and symptoms , such as trials investigating the post-thrombotic syndrome , a frequent chronic complication of deep vein thrombosis .
OBJECTIVE	To determine whether strategies used to blind site investigators , research coordinators and patients were successful in a specific device trial , a multicenter trial of active versus placebo elastic compression stockings worn for 2 years to prevent post-thrombotic syndrome in patients with a first deep vein thrombosis ( the SOX Trial ) .
METHODS	Patients were randomized to the active or placebo stocking intervention , which were indistinguishable in appearance at baseline .
METHODS	Replacement stockings were shipped directly to patients ' homes and were not worn to any of the study visits during the study .
METHODS	Guesstimates of treatment group assignment were completed by site investigators , research coordinators and patients at the end of study follow-up .
METHODS	Statistical assessments of blinding were performed using the James and Bang blinding indices .
RESULTS	Overall rates of correct responses were 10.4 % for site investigators , 17.8 % for research coordinators and 29.4 % for patients .
RESULTS	James blinding index values suggest that blinding was achieved for site investigators , research coordinators and patients .
RESULTS	The treatment specific Bang blinding index values suggest that blinding was achieved for site investigators and research coordinators , but detected possible unblinding and opposite guess for patients in the active and placebo elastic compression stocking groups , respectively .
CONCLUSIONS	Post-study assessment of blinding , as was done for the SOX Trial , can not distinguish between degree of blinding and hunches about an intervention 's efficacy .
CONCLUSIONS	However , as rates of post-thrombotic syndrome along with adverse events in the SOX Trial were similar between treatment groups , it is unlikely that hunches would have interfered with our end-of-trial assessment for blinding .
CONCLUSIONS	Blinding strategies used in our trial were successful overall and appeared to be most effective for site investigators and research coordinators .
CONCLUSIONS	For patients , there may have been some degree of unblinding in the active stocking group .
CONCLUSIONS	However , as the trial results were negative with active elastic compression stocking showing no benefit over placebo elastic compression stocking , this potential unblinding has minimal impact on the overall conclusions of the trial .

###25329643
BACKGROUND	The survival rate of patients with out-of-hospital cardiac arrest is low , and measures to improve the quality of cardiopulmonary resuscitation ( CPR ) during ambulance transportation are desirable .
BACKGROUND	We designed a stabilization device , and in a randomized crossover trial we found performing CPR in a moving ambulance with the device ( MD ) could achieve better efficiency than that without the device ( MND ) , but the efficiency was lower than that in a non-moving ambulance ( NM ) .
OBJECTIVE	To evaluate whether a modified version of the stabilization device , can promote further the quality of CPR during ambulance transportation .
METHODS	Participants of the previous study were recruited , and they performed CPR for 10 minutes in a moving ambulance with the modified version of the stabilization device ( MVSD ) .
METHODS	The primary outcomes were effective chest compressions and no-flow fraction recorded by a skill-reporter manikin .
METHODS	The secondary outcomes included back pain , physiological parameters , and the participants ' rating about the device after performing CPR .
RESULTS	The overall effective compressions in 10 minutes were 86.417.5 % for NM , 60.914.6 % for MND , 69.722.4 % for MD , and 86.6 % 13.2 % for MVSD ( p < 0.001 ) .
RESULTS	Whereas changes in back pain severity and physiology parameters were similar under all conditions , MVSD had the lowest no-flow fraction .
RESULTS	Differences in effective compressions and the no-flow fraction between MVSD and NM did not reach statistical significance .
CONCLUSIONS	The use of the modified device can improve quality of CPR in a moving ambulance to a level similar to that in a non-moving condition without increasing the severity of back pain .

###24908097
BACKGROUND	Volume of para-esophageal varices ( PEV ) correlates with esophageal varices recurrence .
BACKGROUND	The effect of propranolol on volumetric change of PEV has not been studied .
BACKGROUND	The relation between EV recurrence and volumetric change of PEV in patients undergoing endoscopic variceal ligation ( EVL ) with and without propranolol are studied .
METHODS	Sixty-six patients who achieved EV eradication by primary EVL were randomly allocated to a propranolol group ( n = 33 ) or control group ( n = 33 ) .
METHODS	The endpoints of the study were EV recurrence and volumetric change of PEV assessed by using endoscopic ultrasonography ( EUS ) at 3-month intervals for 2 years .
RESULTS	The cumulative probability of recurrence at two years was 28 % in the propranolol group ( n = 9 ) and 68 % in the control group ( n = 20 ) ( p = 0.005 , log-rank test ) .
RESULTS	Difference of the volumetric change of PEV became significant as early as at the third month [ -0.12 ( -0.38 -0.34 ) vs. 0.14 ( -0.06 -0.57 ) , p < 0.001 ] between the two groups .
RESULTS	Regression of PEV was achieved in 20 patients of the propranolol group at a median time of three months ( range 3-12 months ) , and no EV recurrence was found at the end of follow-up for two years .
RESULTS	On multivariate analysis , the volumetric change of PEV at the third month and use of propranolol were determinants of EV recurrence .
CONCLUSIONS	Propranolol may reduce both EV recurrence rate and volume of PEV in patients achieving endoscopic eradication .
CONCLUSIONS	Regression of PEV is a predictor of durable eradication of EV without recurrence in patients using propranolol .
CONCLUSIONS	EUS is an objective and useful tool to measure PEV and predict recurrence of EV .

###25557693
BACKGROUND	Gut dysfunctions may be associated to digestive symptoms .
BACKGROUND	We hypothesized that the gut can also originate pleasant sensations , and wished to demonstrate the hedonic component of the digestive response to a meal .
METHODS	Healthy subjects ( n = 42 ) were evaluated during basal fasting conditions and during experimentally induced fullness sensation ( either by gastric distension or duodenal nutrient infusion ) .
METHODS	In each set of studies , a 240 mL test meal ( 12 kcal broth ) and water , as inert control meal , were administered on separate days in a randomized , cross-over design .
METHODS	Gastric accommodation , the cognitive response and the hedonic dimension ( both by 10 score scales ) were measured 9 min before and 60 min after the meal .
RESULTS	In basal conditions , the test meal induced a significantly greater gastric relaxation than the control meal ( 166 28 mL isotonic volume increase 67 14 mL ; p = 0.002 ) .
RESULTS	Both meals induced epigastric fullness ( 3.8 0.7 score and 3.2 0.8 score , respectively ; p = 0.740 ) , but contrary to the inert meal , with the active meal this conscious sensation had a pleasant dimension ( digestive comfort increase by 1.3 0.6 score with active meal vs -1.1 0.6 decrease with inert meal ; p = 0.015 ) .
RESULTS	Experimentally induced fullness was associated to a decrease in digestive well-being or abdominal discomfort , which improved only after the active meal but not the inert meal .
CONCLUSIONS	When appropriate conditions are met , the response to a meal includes a hedonic dimension involving pleasant sensation of digestive well-being .

###25888263
BACKGROUND	Enzalutamide significantly increased overall survival and radiographic progression-free survival compared with placebo in the PREVAIL trial of asymptomatic and minimally symptomatic , chemotherapy-naive patients with metastatic castration-resistant prostate cancer .
BACKGROUND	We report the effect of enzalutamide on health-related quality of life ( HRQoL ) , pain , and skeletal-related events observed during this trial .
METHODS	In this phase 3 , double-blind trial , patients were randomly assigned ( 1:1 ) to receive enzalutamide 160 mg/day ( n = 872 ) or placebo ( n = 845 ) orally .
METHODS	HRQoL was assessed at baseline and during treatment using the Functional Assessment of Cancer Therapy-Prostate ( FACT-P ) and EQ-5D questionnaires .
METHODS	Pain status was assessed at screening , baseline , week 13 , and week 25 with the Brief Pain Inventory Short Form ( BPI-SF ) .
METHODS	The primary analysis of HRQoL data used a mixed-effects model to test the difference between least square means change from baseline at week 61 .
METHODS	We assessed change from baseline , percentage improvement , and time to deterioration in HRQoL and pain , the proportion of patients with a skeletal-related event , and time to first skeletal-related event .
METHODS	Analysis was done on the intention-to-treat population .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01212991 .
RESULTS	Median treatment duration was 166 months ( IQR 101-211 ) in the enzalutamide group and 46 months ( 28-97 ) in the placebo group .
RESULTS	The mixed-effects model analyses showed significant treatment differences in change from baseline to week 61 with enzalutamide compared with placebo for most FACT-P endpoints and EQ-5D visual analogue scale .
RESULTS	Median time to deterioration in FACT-P total score was 113 months ( 95 % CI 111-139 ) in the enzalutamide group and 56 months ( 55-56 ) in the placebo groups ( hazard ratio [ HR ] 062 [ 95 % CI 054-072 ] ; p < 00001 ) .
RESULTS	A significantly greater proportion of patients in the enzalutamide group than in the placebo group reported clinically meaningful improvements in FACT-P total score ( 327 [ 40 % ] of 826 vs 181 [ 23 % ] of 790 ) , in EQ-5D utility index ( 224 [ 28 % ] of 812 vs 99 [ 16 % ] of 623 ) , and visual analogue scale ( 218 [ 27 % ] of 803 vs 106 of [ 18 % ] 603 ; all p < 00001 ) .
RESULTS	Median time to progression in BPI-SF pain at its worst was 57 months ( 95 % CI 56-57 ) in the enzalutamide group and 56 months ( 54-56 ) in the placebo group ( HR 062 [ 95 % CI 053-074 ] ; p < 00001 ) .
RESULTS	Progression of pain at its worst was less common in the enzalutamide group than in the placebo group at week 13 ( 220 [ 29 % ] of 769 vs 257 [ 42 % ] of 610 ; p < 00001 ) , but not at week 25 ( 225 [ 32 % ] of 705 vs 135 [ 38 % ] of 360 ; p = 0068 ) .
RESULTS	278 ( 32 % ) of 872 patients in the enzalutamide group and 309 ( 37 % ) of 845 patients in the placebo group had experienced a skeletal-related event by data cutoff .
RESULTS	Median time to first skeletal-related events in the enzalutamide group was 311 months ( 95 % CI 295-not reached ) and 313 months ( 95 % CI 239-not reached ) in the placebo group ( HR 072 [ 95 % CI 061-084 ] ; p < 00001 ) .
CONCLUSIONS	In addition to improving overall survival relative to placebo , enzalutamide significantly improves patient-related outcomes and delays occurrence of first skeletal-related event in chemotherapy-naive men with metastatic castration-resistant prostate cancer .
BACKGROUND	Astellas Pharma and Medivation .

###25475245
OBJECTIVE	Heart failure ( HF ) continues to be a leading cause of hospital admissions , particularly in underserved patients .
OBJECTIVE	We hypothesised that providing individualised self-management support to patients and feedback on use of evidence-based HF therapies ( EBT ) to physicians could lead to improvements in care and decrease hospitalisations .
OBJECTIVE	To assess the feasibility of conducting a larger trial testing the efficacy of this dual-level intervention , we conducted the Congestive Heart failure Adherence Redesign Trial Pilot ( CHART-P ) , a proof-of-concept , quasi-experimental , feasibility pilot study .
METHODS	A large tertiary care medical centre in Chicago .
METHODS	Low-income patients ( < US$ 30,000 / year ) hospitalised for exacerbation of systolic HF ( ejection fraction 50 % ) and their physicians .
METHODS	Twenty physicians and 33 patients were enrolled , of whom 23 patients completed the study .
METHODS	Physicians received HF guidelines and periodic individualised feedback on their adherence to EBT .
METHODS	Patients received HF education , support and self-management training for diet and medication adherence by a trained nurse through 11 interactive sessions over a 4-month period .
METHODS	Evaluations were conducted pre-enrolment and 1 month postintervention completion .
METHODS	Feasibility was assessed by the ability to deliver intervention to patients and physicians .
METHODS	Exploratory outcomes included changes in medication and sodium intake for patients and adherence to EBT for physicians .
RESULTS	Eighty-seven per cent and 82 % of patients received > 80 % of interventions at 1 month and by study completion , respectively .
RESULTS	Median sodium intake declined ( 3.5 vs 2.0 g ; p < 0.01 ) .
RESULTS	There was no statistically significant change in medication adherence based on electronic pill cap monitoring or the Morisky Medication Adherence Scale ( MMAS ) ; however , there was a trend towards improved adherence based on MMAS .
RESULTS	All physicians received timely intervention .
CONCLUSIONS	This pilot study demonstrated that the protocol was feasible .
CONCLUSIONS	It provided important insights about the need for intervention and the difficulties in treating patients with a variety of psychosocial problems that undercut their effective care .

###25256180
OBJECTIVE	Evidence indicates that center volume of cases affects outcomes for both carotid endarterectomy and stenting .
OBJECTIVE	We evaluated the effect of enrollment volume by site on complication rates in the Carotid Revascularization Endarterectomy Versus Stenting Trial ( CREST ) .
METHODS	The primary composite end point was any stroke , myocardial infarction , or death within 30 days or ipsilateral stroke in follow-up .
METHODS	The 477 approved surgeons performed > 12 procedures per year with complication rates < 3 % for asymptomatic patients and < 5 % for symptomatic patients ; 224 interventionists were certified after a rigorous 2 step credentialing process .
METHODS	CREST centers were divided into tertiles based on the number of patients enrolled into the study , with Group 1 sites enrolling < 25 patients , Group 2 sites enrolling 25 to 51 patients , and Group 3 sites enrolling > 51 patients .
METHODS	Differences in periprocedural event rates for the primary composite end point and its components were compared using logistic regression adjusting for age , sex , and symptomatic status within site-volume level .
RESULTS	The safety of carotid angioplasty and stenting and carotid endarterectomy did not vary by site-volume during the periprocedural period as indicated by occurrence of the primary end point ( P = 0.54 ) or by stroke and death ( P = 0.87 ) .
RESULTS	A trend toward an inverse relationship between center enrollment volume and complications was mitigated by adjustment for known risk factors .
CONCLUSIONS	Complication rates were low in CREST and were not associated with center enrollment volume .
CONCLUSIONS	The data are consistent with the value of rigorous training and credentialing in trials evaluating endovascular devices and surgical procedures .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00004732 .

###24289099
BACKGROUND	Depressive disorders are highly prevalent and result in negative consequences for both patients and society .
BACKGROUND	It is therefore important that these disorders are treated adequately .
BACKGROUND	However , due to increased demand for mental healthcare and subsequent increased costs , it would be desirable to reduce costs associated with major depressive disorder while maintaining or improving the quality of care within the healthcare system .
BACKGROUND	Introducing evidence-based online self-help interventions in mental healthcare might be the way to maintain clinical effects while minimizing costs by reducing the number of face-to-face sessions .
BACKGROUND	This study aims to evaluate the clinical and economical effects of a guided online self-help intervention when offered to patients with major depressive disorder on a waiting list for psychotherapy in specialized mental health centers ( MHCs ) .
METHODS	Patients at mental health centers identified with a Diagnostic and Statistical Manual of Mental Disorders , fourth edition ( DSM-IV ) diagnosis of major depression who are awaiting face-to-face treatment are studied in a randomized controlled trial .
METHODS	During this waiting list period , patients are randomized and either ( 1 ) receive an internet-based guided self-help treatment or ( 2 ) receive a self-help book .
METHODS	The 5-week internet-based guided self-help intervention and the self-help booklet are based on problem solving treatment .
METHODS	After the intervention , patients are allowed to start regular face-to-face treatment at MHCs .
METHODS	Costs and effects are measured at baseline , after the intervention at 6 to 8 weeks , 6 months and 12 months .
METHODS	The primary outcome measure is symptoms of depression .
METHODS	Secondary outcome measures are diagnosis of depression , number of face-to-face sessions , absence of work and healthcare uptake in general .
METHODS	Additional outcome measures are anxiety , insomnia , quality of life and mastery .
CONCLUSIONS	This study evaluates the effectiveness and cost effectiveness of internet-based guided self-help in patients at specialized mental health centers .
CONCLUSIONS	The aim is to demonstrate whether the introduction of internet-based self-help interventions in regular mental healthcare for depressive disorders can maintain clinical effects and reduce costs .
CONCLUSIONS	Strengths and limitations of this study are discussed .
BACKGROUND	Netherlands Trial Register NTR2824 .

###25813563
OBJECTIVE	We determined the effectiveness of 2 methods to treat overactive bladder in children using intragroup and intergroup comparisons in a randomized clinical trial .
METHODS	Nine boys and 19 girls with a mean SD age of 6.42.18 years were randomly divided into group 1-parasacral transcutaneous electrical stimulation with placebo drug and group 2-oxybutynin with sham scapular electrical therapy .
METHODS	Success was assessed by 1 ) the rate of complete symptom resolution , 2 ) a visual analog scale of 0 to 10 , 3 ) the dysfunctional voiding score system , 4 ) voiding diary records , 5 ) Rome III criteria and 6 ) side effect frequency in each group .
RESULTS	A total of 13 and 15 patients were randomized to groups 1 and 2 , respectively .
RESULTS	Symptoms completely resolved in 6 patients in group 1 ( 46 % ) and 3in group 2 ( 20 % ) ( p = 0.204 ) .
RESULTS	A statistically significant improvement was found in the 2 groups in the dysfunctional voiding score system and voiding diary records .
RESULTS	However , no statistically significant difference was found between the groups in the visual analog scale score , voiding frequency , and maximum and mean voided volume ( p = 0.295 , 0.098 , 0.538 and 0.650 , respectively ) .
RESULTS	Constipation improved in 100 % of group 1 patients but in only 55 % in group 2 ( p = 0.031 vs 0.073 ) .
RESULTS	Group 1 showed no side effects while dry mouth , hyperthermia and hyperemia developed in 58 % , 25 % and 50 % of group 2 patients ( p = 0.002 , 0.096 and 0.005 , respectively ) .
RESULTS	Treatment was discontinued by 13.3 % of patients in group 2 .
CONCLUSIONS	Parasacral transcutaneous electrical stimulation was as effective as oxybutynin to treat overactive bladder in children .
CONCLUSIONS	However , transcutaneous parasacral electrical stimulation was more effective against constipation and showed no detectable side effects .
CONCLUSIONS	Oxybutynin was more effective for decreasing voiding frequency .

###24330310
OBJECTIVE	To evaluate the efficacy of maropitant for prevention of vomiting and gastroesophageal reflux ( GER ) in dogs following acepromazine-hydromorphone premedication and inhalation anesthesia .
METHODS	Randomized , blinded , prospective clinical study .
METHODS	Twenty-six dogs admitted for elective soft tissue or orthopedic procedures that were 3.1 3.1 years of age and weighed 20.5 11.4 kg .
METHODS	Dogs were randomly assigned to one of two groups : Group M received maropitant ( 1.0 mg kg ( -1 ) ) and Group S received 0.9 % saline ( 0.1 mL kg ( -1 ) ) intravenously 45-60 minutes before premedication with hydromorphone ( 0.1 mg kg ( -1 ) ) and acepromazine ( 0.03 mg kg ( -1 ) ) intramuscularly .
METHODS	An observer blinded to treatment documented any retching or vomiting for 20 minutes before induction with propofol ( 2-6 mg kg ( -1 ) ) and inhalation anesthesia .
METHODS	A pH probe inserted into the distal esophagus was used to detect GER .
RESULTS	None of the dogs in Group M retched or vomited ( 0/13 ) , 6/13 ( 46 % ) in Group S were observed to retch or vomit , and the difference between groups was significant ( p = 0.015 ) .
RESULTS	There were no differences between groups in the number of dogs with GER ( Group M : 4/13 , Group S : 6/13 dogs ) or the number of reflux events .
RESULTS	Esophageal pH at the end of anesthesia was significantly lower in both M and S groups in dogs with GER versus dogs without GER ( p = 0.004 and 0.011 , respectively ) .
RESULTS	Only dogs with GER in Group S had significantly lower pH at the end compared to the beginning of anesthesia ( p = 0.004 ) .
CONCLUSIONS	Intravenous maropitant prevented retching and vomiting associated with acepromazine-hydromorphone premedication .
CONCLUSIONS	Maropitant did not prevent the occurrence of GER .
CONCLUSIONS	Fewer dogs in Group M developed GER but further study with a larger number of dogs is necessary to determine if there is a significant difference .

###24736388
BACKGROUND	A large proportion of university students show symptoms of common mental disorders , such as depression , anxiety , substance use disorders and eating disorders .
BACKGROUND	Novel interventions are required that target underlying factors of multiple disorders .
OBJECTIVE	To evaluate the efficacy of a transdiagnostic trait-focused web-based intervention aimed at reducing symptoms of common mental disorders in university students .
METHODS	Students were recruited online ( n = 1047 , age : M = 21.8 , SD = 4.2 ) and categorised into being at high or low risk for mental disorders based on their personality traits .
METHODS	Participants were allocated to a cognitive-behavioural trait-focused ( n = 519 ) or a control intervention ( n = 528 ) using computerised simple randomisation .
METHODS	Both interventions were fully automated and delivered online ( trial registration : ISRCTN14342225 ) .
METHODS	Participants were blinded and outcomes were self-assessed at baseline , at 6 weeks and at 12 weeks after registration .
METHODS	Primary outcomes were current depression and anxiety , assessed on the Patient Health Questionnaire ( PHQ9 ) and Generalised Anxiety Disorder Scale ( GAD7 ) .
METHODS	Secondary outcome measures focused on alcohol use , disordered eating , and other outcomes .
RESULTS	Students at high risk were successfully identified using personality indicators and reported poorer mental health .
RESULTS	A total of 520 students completed the 6-week follow-up and 401 students completed the 12-week follow-up .
RESULTS	Attrition was high across intervention groups , but comparable to other web-based interventions .
RESULTS	Mixed effects analyses revealed that at 12-week follow up the trait-focused intervention reduced depression scores by 3.58 ( p < .001 , 95 % CI [ 5.19 , 1.98 ] ) and anxiety scores by 2.87 ( p = .018 , 95 % CI [ 1.31 , 4.43 ] ) in students at high risk .
RESULTS	In high-risk students , between group effect sizes were 0.58 ( depression ) and 0.42 ( anxiety ) .
RESULTS	In addition , self-esteem was improved .
RESULTS	No changes were observed regarding the use of alcohol or disordered eating .
CONCLUSIONS	This study suggests that a transdiagnostic web-based intervention for university students targeting underlying personality risk factors may be a promising way of preventing common mental disorders with a low-intensity intervention .
BACKGROUND	ControlledTrials.com ISRCTN14342225 .

###24833247
BACKGROUND	Arteriovenous fistulas ( AVFs ) are recommended for hemodialysis access when possible .
BACKGROUND	A noncannulatable but otherwise well functioning AVF leads to prolonged catheter dependency and frustration for the patient and the renal health care provider team .
BACKGROUND	Difficult cannulation patients include obese individuals in whom cannulation sites are too deep , and others with vein segments that are short , tortuous , or otherwise difficult to palpate .
BACKGROUND	The Venous Window Needle Guide for Salvage of AV Fistulae ( SAVE ) trial was designed to evaluate the efficacy and safety of the Venous Window Needle Guide ( VWING ; Vital Access Corp , Salt Lake City , Utah ) device for salvage of such noncannulatable AVFs that are otherwise functional .
METHODS	The SAVE study included patients with an established and otherwise mature AVF , in whom an additional procedure would otherwise be necessary to establish reliable cannulation .
METHODS	The VWING is a single-piece titanium device that allows repeated access of an AVF through a single puncture site ( buttonhole technique ) .
METHODS	Inclusion criteria included mature AVFs 6.0 to 15.0 mm in depth with multiple failed attempts at cannulation or where the access could not be palpated .
METHODS	The devices were implanted subcutaneously and sutured to the anterior wall of the mature fistula .
METHODS	Study end points were reliable and successful cannulation and avoidance of adverse events during the 6-month follow-up , implant technical success , and clinical cannulation success .
RESULTS	Enrollment included 54 patients at 11 trial sites with implantation of 82 VWING devices .
RESULTS	Body mass index was 26 to 50 ( median , 36 ) , 40 ( 74 % ) patients were female , and age was 17 to 84 ( median , 59 ) years .
RESULTS	Forty ( 74 % ) individuals were diabetic .
RESULTS	Thirty-three ( 61 % ) patients were white , 16 ( 30 % ) black , and 10 ( 18 % ) patients were Hispanic , Pacific Islander , or Native American .
RESULTS	Three patients were excluded from data analysis for reasons unrelated to the device .
RESULTS	Successful AVF access was achieved using the VWING in 49 ( 96 % ) of the 51 patients evaluated .
RESULTS	The rate of device-related serious adverse events was 0.31 per patient-year ; each event was resolved leaving the AVF functional .
RESULTS	The rates of sepsis and study-related interventions were 0.04 and 0.65 per patient-year , respectively .
RESULTS	There were no study-related deaths .
RESULTS	One device was removed because of infection .
RESULTS	The AVF survival rate at 6months was 100 % .
RESULTS	The total number of study days was 9497 and the estimated number of device cannulations was4238 .
CONCLUSIONS	The VWING was safe and effective in facilitating AVF cannulation for patients with an otherwise mature but noncannulatable fistula .
CONCLUSIONS	Successful AVF access was achieved using the VWING in 49 ( 96 % ) of the 51 patients evaluated .
CONCLUSIONS	The AVF survival rate at 6months was 100 % .

###25864252
OBJECTIVE	Pain control and early ambulation are two important postoperative goals .
OBJECTIVE	Strategies that decrease morphine use while increasing ambulation have the potential to decrease postoperative complications .
OBJECTIVE	In this study the authors sought to determine the effect of an abdominopelvic binder on postoperative morphine use , pain , and ambulation in the first day after surgery .
METHODS	The authors randomly assigned 75 patients undergoing abdominal gynecologic surgery to either binder or not after surgery .
METHODS	Demographic data and surgical characteristics were collected .
METHODS	Outcome variables included morphine use , pain score , time to ambulation , and number of ambulations .
RESULTS	A group at high risk for decreased mobility was identified and the binder increased the number of ambulatory events by 300 % , 260 % , and 240 % in patients with vertical incisions , age over 50 years , and complex surgeries , respectively .
RESULTS	Morphine use and pain scores were not significantly different .
CONCLUSIONS	The binder increased ambulations in the subset of patients at the highest risk for postoperative complications : elderly , cancer patients , and vertical incisions .
CONCLUSIONS	Routine use of the binder may benefit particularly high-risk gynecologic surgical patients .

###24565090
OBJECTIVE	There are several formulations of propofol available to the anesthesiologist for clinical use .
OBJECTIVE	The aim of this study was to analyze the physicochemical properties , pharmacodynamic effect , and pharmaceutical and clinical equivalence of the reference drug propofol as well as a similar formulation .
METHODS	Sixteen volunteers were enrolled in this randomized , double-blind , and paired study of Diprivan and Propovan formulations .
METHODS	Formulations were given as target-controlled infusion with target concentration of 3.0 g.mL ( -1 ) for 15 minutes .
METHODS	Variables studied were the area under the curve ( AUC ) of the bispectral index ( BIS ) graph regarding time , minimum BIS reached and time to reach it , and recovery time .
METHODS	The two formulations were sent to analysis of particle size of lipid emulsion , surface potential , and active principle quantification .
RESULTS	There was no difference between the formulations when comparing AUC , minimum BIS reached and time to reach it .
RESULTS	The similar formulation recovery time was lower compared to the reference formulation ( eight and 10 min , respectively , p = 0.014 ) .
RESULTS	Mean particle size of lipid emulsion , surface potential , and active ingredient quantification were similar for both formulations .
CONCLUSIONS	There was no clinically significant difference between the use of propofol , reference Diprivan , and the similar Propovan during infusion .
CONCLUSIONS	However , the recovery time was longer with the reference drug .
CONCLUSIONS	Although analysis of both formulations studied show similar results regarding its physicochemical characterization , further studies should be conducted to justify this difference .

###25286913
BACKGROUND	No treatment strategies have been demonstrated to be beneficial for the population for patients with heart failure ( HF ) and preserved ejection fraction ( EF ) .
RESULTS	The CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients ( CHAMPION ) trial was a prospective , single-blinded , randomized controlled clinical trial testing the hypothesis that hemodynamically guided HF management decreases decompensation leading to hospitalization .
RESULTS	Of the 550 patients enrolled in the study , 119 had left ventricular EF 40 % ( average , 50.6 % ) , 430 patients had low left ventricular EF ( < 40 % ; average , 23.3 % ) , and 1 patient had no documented left ventricular EF .
RESULTS	A microelectromechanical system pressure sensor was permanently implanted in all participants during right heart catheterization .
RESULTS	After implant , subjects were randomly assigned in single-blind fashion to a treatment group in whom daily uploaded pressures were used in a treatment strategy for HF management or to a control group in whom standard HF management included weight-monitoring , and pressures were uploaded but not available for investigator use .
RESULTS	The primary efficacy end point of HF hospitalization rate > 6 months for preserved EF patients was 46 % lower in the treatment group compared with control ( incidence rate ratio , 0.54 ; 95 % confidence interval , 0.38-0 .70 ; P < 0.0001 ) .
RESULTS	After an average of 17.6 months of blinded follow-up , the hospitalization rate was 50 % lower ( incidence rate ratio , 0.50 ; 95 % confidence interval , 0.35-0 .70 ; P < 0.0001 ) .
RESULTS	In response to pulmonary artery pressure information , more changes in diuretic and vasodilator therapies were made in the treatment group .
CONCLUSIONS	Hemodynamically guided management of patients with HF with preserved EF reduced decompensation leading to hospitalization compared with standard HF management strategies .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00531661 .

###25858974
BACKGROUND	Most inspiratory muscle training ( IMT ) interventions in patients with chronic obstructive pulmonary disease ( COPD ) have been implemented as fully supervised daily training for 30 minutes with controlled training loads using mechanical threshold loading ( MTL ) devices .
BACKGROUND	Recently , an electronic tapered flow resistive loading ( TFRL ) device was introduced that has a different loading profile and stores training data during IMT sessions .
OBJECTIVE	The aim of this study was to compare the efficacy of a brief , largely unsupervised IMT protocol conducted using either traditional MTL or TFRL on inspiratory muscle function in patients with COPD .
METHODS	Twenty patients with inspiratory muscle weakness who were clinically stable and participating in a pulmonary rehabilitation program were randomly allocated to perform 8 weeks of either MTL IMT or TFRL IMT .
METHODS	Participants performed 2 daily home-based IMT sessions of 30 breaths ( 3-5 minutes per session ) at the highest tolerable intensity , supported by twice-weekly supervised sessions .
METHODS	Adherence , progression of training intensity , increases in maximal inspiratory mouth pressure ( Pimax ) , and endurance capacity of inspiratory muscles ( Tlim ) were evaluated .
RESULTS	More than 90 % of IMT sessions were completed in both groups .
RESULTS	The TFRL group tolerated higher loads during the final 3 weeks of the IMT program , with similar effort scores on the 10-Item Borg Category Ratio ( CR-10 ) Scale , and achieved larger improvements in Pimax and Tlim than the MTL group .
CONCLUSIONS	A limitation of the study was the absence of a study arm involving a sham IMT intervention .
CONCLUSIONS	The short and largely home-based IMT protocol significantly improved inspiratory muscle function in both groups and is an alternative to traditional IMT protocols in this population .
CONCLUSIONS	Participants in the TFRL group tolerated higher training loads and achieved larger improvements in inspiratory muscle function than those in the MTL group .

###25262372
BACKGROUND	Too many young people engage in unhealthy behaviours such as eating unhealthily , being physically inactive , binge drinking and smoking .
BACKGROUND	This study aimed to estimate the short-term and long-term cost-effectiveness of a theory-based online health behaviour intervention ( `` U@Uni '' ) in comparison with control in young people starting university .
METHODS	A costing analysis was conducted to estimate the full cost of U@Uni and the cost of U@Uni roll-out .
METHODS	The short-term cost-effectiveness of U@Uni was estimated using statistical analysis of 6-month cost and health-related quality of life data from the U@Uni randomised controlled trial .
METHODS	An economic modelling analysis combined evidence from the trial with published evidence of the effect of health behaviours on mortality risk and general population data on health behaviours , to estimate the lifetime cost-effectiveness of U@Uni in terms of incremental cost per QALY .
METHODS	Costs and effects were discounted at 1.5 % per annum .
METHODS	A full probabilistic sensitivity analysis was conducted to account for uncertainty in model inputs and provide an estimate of the value of information for groups of important parameters .
RESULTS	To implement U@Uni for the randomised controlled trial was estimated to cost 292 per participant , whereas roll-out to another university was estimated to cost 19.71 , both giving a QALY gain of 0.0128 per participant .
RESULTS	The short-term ( 6-month ) analysis suggested that U@Uni would not be cost-effective at a willingness-to-pay threshold of 20,000 per QALY ( incremental cost per QALY gained = 243,926 ) .
RESULTS	When a lifetime horizon was adopted the results suggest that the full implementation of U@Uni is unlikely to be cost-effective , whereas the roll-out of U@Uni to another university is extremely likely to be cost-effective .
RESULTS	The value of information analysis suggests that the most important drivers of decision uncertainty are uncertainties in the effect of U@Uni on health behaviours .
CONCLUSIONS	The study provides the first estimate of the costs and cost-effectiveness of an online health behaviour intervention targeted at new university students .
CONCLUSIONS	The results suggest that the roll-out , but not the full implementation , of U@Uni would be a cost-effective decision for the UK Department of Health , given a lifetime perspective and a willingness-to pay threshold of 20,000 per QALY .
BACKGROUND	Current Controlled Trials ISRCTN67684181 .

###25182269
BACKGROUND	Depression is a widespread and serious disease often accompanied by a high degree of suffering and burden of disease .
BACKGROUND	The lack of integration between different care providers impedes guideline-based treatment .
BACKGROUND	This constitutes substantial challenges for the health care system and also causes considerable direct and indirect costs .
BACKGROUND	To face these challenges , the aim of this project is the implementation and evaluation of a guideline-based stepped care model for depressed patients with six treatment options of varying intensity and setting , including low-intensity treatments using innovative technologies .
METHODS	The study is a randomized controlled intervention trial of a consecutive sample of depressive patients from primary care assessed with a prospective survey at four time-standardized measurement points within one year .
METHODS	A cluster randomization at the level of participating primary care units divides the general practitioners into two groups .
METHODS	In the intervention group patients ( n = 660 ) are treated within the stepped care approach in a multiprofessional network consisting of general practitioners , psychotherapists , psychiatrists and inpatient care facilities , whereas patients in the control condition ( n = 200 ) receive routine care .
METHODS	The main research question concerns the effectiveness of the stepped-care model from baseline to t3 ( 12 months ) .
METHODS	Primary outcome is the change in depressive symptoms measured by the PHQ-9 ; secondary outcomes include response , remission and relapse , functional quality of life ( SF-12 and EQ-5D-3 L ) , other clinical and psychosocial variables , direct and indirect costs , and the incremental cost-effectiveness ratio .
METHODS	Furthermore feasibility and acceptance of the overall model as well as of the separate treatment components are assessed .
CONCLUSIONS	This stepped care model integrates all primary and secondary health care providers involved in the treatment of depression ; it elaborates innovative and evidence-based treatment elements , follows a stratified approach and is implemented in routine care as opposed to standardized conditions .
CONCLUSIONS	In case of positive results , its sustainable implementation as a collaborative care model may significantly improve the health care situation of depressive patients as well as the interaction and care delivery of different care providers on various levels .
BACKGROUND	This study is registered with ClinicalTrials.gov , number NCT01731717 ( date of registration : 24 June 2013 ) .

###24666664
OBJECTIVE	Evaluate aberrant drug-related behaviors in patients administering fentanyl buccal tablet or traditional short-acting opioids for breakthrough pain .
METHODS	Twelve-week open-label extension .
METHODS	Forty-two US sites .
METHODS	Opioid-tolerant patients with chronic pain who completed the previous randomized , double-blind , crossover portion of a study comparing fentanyl buccal tablet and immediate-release oxycodone for treatment of breakthrough pain .
METHODS	Patients were rerandomized to continue treatment with fentanyl buccal tablet or begin any traditional short-acting opioid .
METHODS	Assessments included Screener and Opioid Assessment for Patients with Pain-Revised ( SOAPP-R ) at baseline and Addiction Behaviors Checklist and Current Opioid Misuse Measure at baseline and final visit .
METHODS	Case report forms were reviewed retrospectively to identify aberrant drug-related behaviors .
RESULTS	One hundred thirty patients entered the open-label extension ( fentanyl buccal tablet , N = 65 ; traditional short-acting opioid , N = 65 ) .
RESULTS	SOAPP-R scores were < 18 ( low risk of aberrant drug-related behavior ) in 74 % of patients ; no significant differences in SOAPP-R scores were observed between treatment groups .
RESULTS	At the final visit , 14 % of patients in each treatment group had scores indicating potential aberrant drug-related behavior ( Addiction Behaviors Checklist 3 , Current Opioid Misuse Measure 9 ) ; no significant differences in scores were observed between treatment groups .
RESULTS	Baseline SOAPP-R score 18 was not predictive of Addiction Behaviors Checklist 3 but was predictive of Current Opioid Misuse Measure 9 .
RESULTS	Aberrant behaviors were identified in 12 ( 18 % ) fentanyl buccal tablet patients and 13 ( 20 % ) traditional short-acting opioid patients .
CONCLUSIONS	Incidence of aberrant drug-related behaviors was similar between patients taking fentanyl buccal tablet and traditional short-acting opioids over 12 weeks .

###25332355
OBJECTIVE	To test the effectiveness of multiple interventions on increasing the response rate of text messaging for longitudinal data collection .
METHODS	Our cohort included 283 caregivers of children aged 6-12months who were participating in an anemia program in rural China .
METHODS	Using text messages to collect data on anemia medication adherence , we conducted a delayed randomized controlled trial to test multiple interventions ( an additional four reminders ; a 5.0 ( US$ 0.79 ) credit reward for replying ; and a feedback text message ) .
METHODS	After a 6-week pilot study with week 7 as the baseline measurement , we randomly allocated all participants into two groups : group 1 ( n = 142 ) and group 2 ( n = 141 ) .
METHODS	During weeks 8-11 , we introduced the interventions to group 1 , and in weeks 12-15 the intervention was introduced to both groups .
METHODS	We compared the response rates between groups and explored factors affecting the response rate .
RESULTS	During weeks 8-11 , the response rates in group 1 increased and were significantly higher than in group 2 ( p < 0.05 ) .
RESULTS	During weeks 12-15 , the response rate increased significantly in group 2 ( p > 0.05 ) and slightly decreased in group 1 .
RESULTS	Younger participants or participants who had children with lower hemoglobin concentration were more likely to reply ( p = 0.02 ) .
RESULTS	Sending four reminders on the second day contributed to only 286 ( 11.7 % ) extra text messages .
CONCLUSIONS	Our study showed that multiple interventions were effective in increasing response rate of text messaging data collection in rural China .
CONCLUSIONS	Larger multi-site studies are needed to find the most effective way of using these interventions to allow usage of text messaging data collection for health research .

###24504007
BACKGROUND	Lobectomy for non-small cell lung cancer ( NSCLC ) can be performed either through open thoracotomy or video-assisted thoracoscopic surgery ( VATS ) .
BACKGROUND	To improve the understanding of current attitudes of the thoracic community toward VATS lobectomy , the Collaborative Research Group conducted the Cross-sectional Survey on Lobectomy Approach ( X-SOLA ) study .
BACKGROUND	We surveyed a large cohort of lobectomy-performing thoracic surgeons to examine their adoption of VATS lobectomy and their opinions of this technique vs conventional open thoracotomy .
METHODS	Participants included thoracic surgeons identified through an international index search from the Web of Science and the cardiothoracic surgery network .
METHODS	A confidential questionnaire was e-mailed in June 2012 .
METHODS	Nonresponders were given two reminder e-mails at monthly intervals .
RESULTS	The questionnaire , completed by 838 thoracic surgeons within a 3-month period , identified 416 surgeons who only performed lobectomy through open thoracotomy and 422 surgeons who performed VATS or robotic VATS .
RESULTS	Of those who performed VATS , 95 % agreed with the definition of `` true '' VATS lobectomy according to the Cancer and Leukemia Group B trial .
RESULTS	Ninety-two percent of surgeons who did not perform VATS lobectomy responded that they were willing to learn this technique , but were hindered by limited resources , exposure , and mentoring .
RESULTS	Both groups agreed there was a need for VATS lobectomy training in thoracic residency programs and in standardized workshops .
CONCLUSIONS	X-SOLA represents the largest cross-sectional report within the thoracic community to date , demonstrating the penetration of VATS lobectomy for NSCLC internationally .
CONCLUSIONS	From our study , we were able to identify a number of obstacles to broaden the adoption of this minimally invasive technique .

###26219161
OBJECTIVE	To explore a better anesthesia method for the patients with gastric cancer who will undergo operation by investigating the impact of different anesthesia methods on stress reaction and immune function .
METHODS	The present prospective study was carried out in Xiangyang Central Hospital , China , between January 2008 and August 2014 .
METHODS	Sixty-four cases of antral carcinoma , subjected to radical resection of gastric cancer were randomly divided into general anesthesia group ( GA group ) and general anesthesia combined with continuous epidural anesthesia group ( GCEA group ) .
METHODS	The peripheral venous bloods were sampled to determine the content of TNF - , IL-6 , IL-8 , T-lymphocyte subsets , and natural killer ( NK ) cells .
METHODS	The data was analyzed by SPSS 13.0 .
RESULTS	After operation , the content of TNF - , IL-6 , and IL-8 in GCEA group were significant lower than that in GA group ( p < 0.05 ) .
RESULTS	At the end ofthe operation , the content of T-lymphocyte subsets and NK cells in GA and GCEA groups descended significantly , but GA group was larger ( p < 0.01 vs. p < 0.05 ) .
RESULTS	Seventy-two hours after the operation , the content of T-lymphocyte subsets and NK cells in GCEA group were back to normal , but it was significantly lower than before anesthesia ( p < 0.05 ) in the GA group .
CONCLUSIONS	Compared to GA , GCEA is a better anesthesia method for gastric cancer patient who will undergo operation because it has lower stress reaction and less impact on immune function .

###24447620
OBJECTIVE	To assess the efficacy and safety of olesoxime , a molecule with neuroprotective properties , in patients with amyotrophic lateral sclerosis ( ALS ) treated with riluzole .
METHODS	A double-blind , randomized , placebo-controlled , multicenter trial of 18 months ' duration was conducted in 512 subjects , with probable or definite ALS and a slow vital capacity ( SVC ) 70 % , receiving 330 mg olesoxime daily or matching placebo and 50 mg riluzole twice a day in all .
METHODS	The primary intention-to-treat ( ITT ) outcome analysis was 18 months ' survival .
METHODS	Secondary outcomes were rates of deterioration of the revised ALS functional rating scale ( ALSFRS-R ) , focusing on the 9-month assessment , SVC and manual muscle testing .
METHODS	Blood levels , safety and tolerability of olesoxime were also assessed .
RESULTS	At 18 months , 154 of the 512 ITT patients had died ( 79 of 253 placebo , 75 of 259 olesoxime ) .
RESULTS	Estimated overall survival according to Kaplan-Meier analysis was 67.5 % ( 95 % CI 61.0 % -73.1 % ) in the placebo group and 69.4 % ( 95 % CI 63.0 % -74.9 % ) in the olesoxime group ; hence survival was not significantly different between treatment arms ( P = 0.71 , stratified bulbar/spinal log-rank ) .
RESULTS	The other efficacy end-points evaluated were also negative , with the exception of a small difference in ALSFRS-R global score at 9 months in favor of olesoxime but not sustained after 18 months ' treatment nor evident in either the stratified bulbar or spinal subpopulations .
RESULTS	Treatment did not raise any safety concerns .
CONCLUSIONS	Olesoxime , although well tolerated , did not show a significant beneficial effect in ALS patients treated with riluzole .

###24729398
OBJECTIVE	The aim of this study was to assess the efficacy and safety of golimumab in Chinese patients with active AS .
METHODS	Two hundred and thirteen patients were randomized in a 1:1 ratio to receive either s.c. injections of placebo from weeks 0 to 20 followed by golimumab 50 mg from weeks 24 to 48 ( group 1 , n = 105 ) or golimumab 50 mg from weeks 0 to 48 ( group 2 , n = 108 ) , both every 4 weeks .
METHODS	Placebo crossover occurred at week 24 , while early escape was at week 16 .
METHODS	The primary endpoint was an improvement of at least 20 % in the Assessment of SpondyloArthritis international Society ( ASAS20 ) criteria at week 14 .
METHODS	Major secondary endpoints included week 24 ASAS20 response and week 14 change scores for BASFI and BASMI .
RESULTS	Golimumab treatment elicited significantly better responses than placebo in week 14 ASAS20 response [ 49.1 % ( 53/108 ) vs 24.8 % ( 26/105 ) , respectively , P < 0.001 ] , week 24 ASAS20 response ( 50.0 % vs 22.9 % , P < 0.001 ) and mean improvements in BASFI ( -1.26 vs 0.11 , P < 0.001 ) and BASMI ( -0.42 vs -0.19 , P = 0.021 ) scores at week 14 .
RESULTS	Additionally , golimumab treatment led to significant improvements in the mental and physical components of health-related quality of life ( HRQoL ) and sleep problems at week 24 , all of which were further improved through week 52 .
RESULTS	During the 16-week placebo-controlled study period , 31.4 % and 30.6 % of patients had adverse events ( AEs ) in groups 1 and 2 , respectively ; similar AE reporting rates were observed through week 24 ( 34.3 % and 32.0 % ) and among the golimumab-treated patients through week 56 ( 41.2 % ) .
CONCLUSIONS	Golimumab significantly reduced clinical symptoms/signs and improved physical function , range of motion and HRQoL in Chinese patients with active AS without unexpected safety concerns .
BACKGROUND	ClinicalTrials.gov , NCT01248793 .

###24937345
BACKGROUND	Little is known regarding the epidemiology of intraoperative Staphylococcus aureus transmission .
BACKGROUND	The primary aim of this study was to examine the mode of transmission , reservoir of origin , transmission locations , and antibiotic susceptibility for frequently encountered S aureus strains ( phenotypes ) in the anesthesia work area .
BACKGROUND	Our secondary aims were to examine phenotypic associations with 30-day postoperative patient cultures , phenotypic growth rates , and risk factors for phenotypic isolation .
METHODS	S aureus isolates previously identified as possible intraoperative bacterial transmission events by class of pathogen , temporal association , and analytical profile indexing were subjected to antibiotic disk diffusion sensitivity .
METHODS	The combination of these techniques was then used to confirm S aureus transmission events and to classify them as occurring within or between operative cases ( mode ) .
METHODS	The origin of S aureus transmission events was determined via use of a previously validated experimental model and links to 30-day postoperative patient cultures confirmed via pulsed-field gel electrophoresis .
METHODS	Growth rates were assessed via time-to-positivity analysis , and risk factors for isolation were characterized via logistic regression .
RESULTS	One hundred seventy S aureus isolates previously implicated as possible intraoperative transmission events were further subdivided by analytical profile indexing phenotype .
RESULTS	Two phenotypes , phenotype P ( patients ) and phenotype H ( hands ) , accounted for 65 % of isolates .
RESULTS	Phenotype P and phenotype H contributed to at least 1 confirmed transmission event in 39 % and 28 % of cases , respectively .
RESULTS	Patient skin surfaces ( odds ratio [ OR ] , 8.40 ; 95 % confidence interval [ CI ] , 2.30-30 .73 ) and environmental ( OR , 10.89 ; 95 % CI , 1.29-92 .13 ) samples were more likely than provider hands ( referent ) to have phenotype P positivity .
RESULTS	Phenotype P was more likely than phenotype H to be resistant to methicillin ( OR , 4.38 ; 95 % CI , 1.59-12 .06 ; P = 0.004 ) and to be linked to 30-day postoperative patient cultures ( risk ratio , 36.63 [ risk difference , 0.174 ; 95 % CI , 0.019-0 .328 ] ; P < 0.001 ) .
RESULTS	Phenotype P exhibited a faster growth rate for methicillin resistant and for methicillin susceptible than phenotype H ( phenotype P : median , 10.32 H ; interquartile range , 10.08-10 .56 ; phenotype H : median , 10.56 H ; interquartile range , 10.32-10 .8 ; P = 0.012 ) .
RESULTS	Risk factors for isolation of phenotype P included age ( OR , 14.11 ; 95 % CI , 3.12-63 .5 ; P = 0.001 ) and patient exposure to the hospital ward ( OR , 41.11 ; 95 % CI , 5.30-318 .78 ; P < 0.001 ) .
CONCLUSIONS	Two S aureus phenotypes are frequently transmitted in the anesthesia work area .
CONCLUSIONS	A patient and environmentally derived phenotype is associated with increased risk of antibiotic resistance and links to 30-day postoperative patient cultures as compared with a provider hand-derived phenotype .
CONCLUSIONS	Future work should be directed toward improved screening and decolonization of patients entering the perioperative arena and improved intraoperative environmental cleaning to attenuate postoperative health care-associated infections .

###25505238
BACKGROUND	The results of the European Randomized Study of Screening for Prostate Cancer ( ERSPC ) trial showed a statistically significant 29 % prostate cancer mortality reduction for the men screened in the intervention arm and a 23 % negative impact on the life-years gained because of quality of life .
BACKGROUND	However , alternative prostate-specific antigen ( PSA ) screening strategies for the population may exist , optimizing the effects on mortality reduction , quality of life , overdiagnosis , and costs .
METHODS	Based on data of the ERSPC trial , we predicted the numbers of prostate cancers diagnosed , prostate cancer deaths averted , life-years and quality-adjusted life-years ( QALY ) gained , and cost-effectiveness of 68 screening strategies starting at age 55 years , with a PSA threshold of 3 , using microsimulation modeling .
METHODS	The screening strategies varied by age to stop screening and screening interval ( one to 14 years or once in a lifetime screens ) , and therefore number of tests .
RESULTS	Screening at short intervals of three years or less was more cost-effective than using longer intervals .
RESULTS	Screening at ages 55 to 59 years with two-year intervals had an incremental cost-effectiveness ratio of $ 73000 per QALY gained and was considered optimal .
RESULTS	With this strategy , lifetime prostate cancer mortality reduction was predicted as 13 % , and 33 % of the screen-detected cancers were overdiagnosed .
RESULTS	When better quality of life for the post-treatment period could be achieved , an older age of 65 to 72 years for ending screening was obtained .
CONCLUSIONS	Prostate cancer screening can be cost-effective when it is limited to two or three screens between ages 55 to 59 years .
CONCLUSIONS	Screening above age 63 years is less cost-effective because of loss of QALYs because of overdiagnosis .

###25374047
BACKGROUND	Nearly 1 in 5 people living with HIV in the United States are unaware they are infected .
BACKGROUND	Therefore , it is important to develop and evaluate health communication messages that clinicians can use to encourage HIV testing .
METHODS	The objective was to evaluate health communication messages designed to increase HIV testing rates among women and evaluate possible moderators of message effect .
METHODS	We used a randomized four-arm clinical trial conducted at urban community outpatient health clinics involving 1,919 female patients , 18 to 64 years old .
METHODS	The four health message intervention groups were : i ) information-only control ; ii ) one-sided message describing the advantages of HIV testing ; iii ) two-sided message acknowledging a superficial objection to testing ( i.e. , a 20 minute wait for results ) followed by a description of the advantages of testing ; and iv ) two-sided message acknowledging a serious objection ( i.e. , fear of testing positive for HIV ) followed by a description of the advantages of testing .
METHODS	The main outcome was acceptance of an oral rapid HIV test .
RESULTS	Participants were randomized to receive the control message ( n = 483 ) , one-sided message ( n = 480 ) , two-sided message with a superficial objection ( n = 481 ) , or two-sided message with a serious objection ( n = 475 ) .
RESULTS	The overall rate of HIV test acceptance was 83 % .
RESULTS	The two-sided message groups were not significantly different from the controls .
RESULTS	The one-sided message group , however , had a lower rate of testing ( 80 % ) than the controls ( 86 % ) ( OR , 0.66 ; 95 % CI , 0.47-0 .93 ; P = 0.018 ) .
RESULTS	`` Perceived obstacles to HIV testing '' moderated this effect , indicating that the decrease in HIV test acceptance for the one-sided message group was only statistically significant for those who had reported high levels of obstacles to HIV testing ( OR , 0.36 ; 95 % CI , 0.19-0 .67 ; P = 0.001 ) .
CONCLUSIONS	None of the messages increased test acceptance .
CONCLUSIONS	The one-sided message decreased acceptance and this effect was particularly true for women with greater perceived obstacles to testing , the very group one would most want to persuade .
CONCLUSIONS	This finding suggests that efforts to persuade those who are reluctant to get tested , in some circumstances , may have unanticipated negative effects .
CONCLUSIONS	Other approaches to messaging around HIV testing should be investigated , particularly with diverse , behaviorally high-risk populations .
BACKGROUND	Clinicaltrials.gov Identifier : NCT00771537 .
BACKGROUND	Registration date : October 10.2008 .

###25228440
OBJECTIVE	To investigate functional and macular pigment ( MP ) changes in patients with early age-related macular degeneration ( AMD ) after multiple supplementation with lutein and zeaxanthin .
METHODS	112 patients with early AMD were randomly ( 1:1:1:1 ) assigned to receive 10mg lutein , 20mg lutein , lutein ( 10mg ) + zeaxanthin ( 10mg ) , or placebo daily for 2years .
METHODS	MP optical density ( MPOD ) was recorded at baseline , 48weeks and 2years .
METHODS	Retinal sensitivities were measured by multifocal electroretinogram for peak-to-trough amplitude ( N1P1 ) at baseline and at 48weeks , and in terms of microperimeter-determined mean retinal sensitivity ( MRS ) at 48weeks and 2years .
RESULTS	Supplementation with lutein and zeaxanthin augmented MPOD significantly in active treatment groups ( all p < 0.05 ) .
RESULTS	N1P1 response densities showed significant increases in ring 1 and ring 2 after 48weeks of supplementation , while no significant changes were seen in rings 3-6 .
RESULTS	Significant increases in MRS were detected after supplementation with either 10 or 20mg lutein , whereas no such increases were seen in the placebo arm .
CONCLUSIONS	Supplementation with lutein and/or zeaxanthin increases MPOD , and supplemental lutein enhances retinal sensitivity , in patients with early AMD .
BACKGROUND	Clinicaltrials.gov NCT10528605 .

###25202935
METHODS	Prospective randomized study .
OBJECTIVE	To determine whether single-level posterolateral lumbar fusion ( PLF ) or posterior lumbar interbody fusion ( PLIF ) was associated with better outcomes for patients 60 years or younger with isthmic spondylolisthesis .
BACKGROUND	Although both PLF and PLIF are considered effective surgical treatments for isthmic spondylolisthesis , it is unknown which treatment leads to better outcomes .
BACKGROUND	In addition , previous studies of the therapeutic efficacy of PLIF and PLF had several weaknesses , so they could not provide clear data on the therapeutic outcomes of each treatment .
METHODS	Of the 85 patients screened for this study , 4 did not meet the study criteria .
METHODS	Thus , 81 patients were enrolled and randomly assigned into group A ( PLF , n = 39 ) or group B ( PLIF , n = 42 ) .
METHODS	The primary outcome measure was the fusion rate based on dynamic radiographs and computed tomographic scans at postoperative 1 and 2 years .
METHODS	The secondary outcome measures were ( 1 ) clinical outcomes as assessed with a visual analogue scale and the Oswestry Disability Index , ( 2 ) surgical outcomes , and ( 3 ) additional outcomes such as infection and metal failure .
RESULTS	No patients were lost to follow-up .
RESULTS	The fusion rate was similar between groups : fusion occurred in 84.6 % ( 33/39 ) in group A and 85.7 % ( 36/42 ) in group B at 1 year after surgery ( P = 0.86 ) , and 89.7 % ( 35/39 ) in group A and 90.4 % ( 38/42 ) in group B at 2 years after surgery ( P = 0.93 ) .
RESULTS	Postoperative pain levels and functional outcomes did not differ significantly between groups at any of the regular follow-up visits .
RESULTS	The prevalence of complications also did not differ significantly between groups ; the only serious complication ( deep infection ) occurred in 1 patient in the PLIF group .
CONCLUSIONS	Both PLF and PLIF are viable surgical options for patients with isthmic spondylolisthesis 60 years or younger .

###26231624
BACKGROUND	Constraint-induced movement therapy ( CIMT ) is recommended for patients with upper limb dysfunction after stroke , yet evidence to support the implementation of CIMT in ambulatory care is insufficient .
BACKGROUND	We assessed the efficacy of home CIMT , a modified form of CIMT that trains arm use in daily activities within the home environment .
METHODS	In this parallel , cluster-randomised controlled trial , we selected 71 therapy practices in northern Germany that treat adult patients with upper limb dysfunction after stroke .
METHODS	Practices were stratified by region and randomly allocated by an external biometrician ( 1:1 , block size of four ) using a computer-generated sequence .
METHODS	37 practices were randomly assigned to provide 4 weeks of home CIMT and 34 practices to provide 4 weeks of standard therapy .
METHODS	Eligible patients had mild to moderate impairment of arm function at least 6 months after stroke and a friend or family member willing to participate as a non-professional coach .
METHODS	Patients of both groups received 5 h of professional therapist contact in 4 weeks .
METHODS	In the home CIMT group , therapists used the contact time to instruct and supervise patients and coaches in home CIMT .
METHODS	Patients in the standard therapy group received conventional physical or occupational therapy , but additional home training was not obligatory .
METHODS	All assessments were done by masked outcome assessors at baseline , after 4 weeks of intervention , and at 6 month follow-up .
METHODS	The primary outcomes were quality of movement , assessed by the Motor Activity Log ( MAL-QOM , assessor-assisted self-reported ) , and performance time , assessed by the Wolf Motor Function Test ( WMFT-PT , assessor-reported ) .
METHODS	Primary outcomes were tested hierarchically after 4 weeks of intervention and analysed by intention to treat , using mixed linear models .
METHODS	This trial is registered with ClinicalTrials.gov , NCT01343602 .
RESULTS	Between July 11 , 2011 , and June 4 , 2013 , 85 of 156 enrolled patients were assigned home CIMT and 71 patients were assigned standard therapy .
RESULTS	82 ( 96 % ) patients in the home CIMT group and 71 ( 100 % ) patients in the standard therapy group completed treatment and were assessed at 4 weeks .
RESULTS	Patients in both groups improved in quality of movement ( MAL-QOM ; change from baseline 056 , 95 % CI 041-071 , p < 00001 for home CIMT vs 031 , 015-046 , p = 00003 for standard therapy ) .
RESULTS	Patients in the home CIMT group improved more than patients in the standard therapy group ( between-group difference 026 , 95 % CI 005-046 ; p = 00156 ) .
RESULTS	Both groups also improved in motor function performance time ( WMFT-PT ; change from baseline -2560 % , 95 % CI -3675 to -1249 , p = 00006 for home CIMT vs -2752 % , -3894 to -1394 , p = 00004 for standard therapy ) , but the extent of improvement did not differ between groups ( 265 % , -1794 to 2840 ; p = 08152 ) .
RESULTS	Nine adverse events ( of which six were serious ) were reported in the home CIMT group and ten ( of which seven were serious ) in the standard therapy group ; however , none was deemed related to the study intervention .
CONCLUSIONS	Home-based CIMT can enhance the perceived use of the stroke-affected arm in daily activities more effectively than conventional therapy , but was not superior with respect to motor function .
CONCLUSIONS	Further research is needed to confirm whether home CIMT leads to clinically significant improvements and if so to identify patients that are most likely to benefit .
BACKGROUND	German Federal Ministry of Education and Research .

###25050368
OBJECTIVE	Our main purpose was to compare safety and efficacy in the treatment of progressive keratoconus with `` epithelium-on '' and `` epithelium-off '' corneal collagen cross-linking ( CXL ) .
OBJECTIVE	Our secondary purpose was to evaluate efficacy of CXL when hypotonic 0.5 % riboflavin is used as photosensitizer .
METHODS	One eye of 20 patients with bilateral progressive keratoconus was randomly treated for `` epithelium-on '' CXL ( group 1 ) while the fellow eye underwent `` epithelium-off '' CXL ( group 2 ) .
METHODS	Hypotonic 0.5 % riboflavin was used in both groups .
METHODS	Visual acuity , refraction , corneal topography , and wavefront aberrometry were evaluated at baseline and after 1 , 6 , and 12 months .
METHODS	Specular microscopy was performed on 10 patients preoperatively and after 12 months .
METHODS	Postoperative pain was evaluated using a patient questionnaire .
RESULTS	Uncorrected and corrected distance visual acuity improved significantly in both groups .
RESULTS	Refraction , topography , and aberrometry showed nonsignificant changes from the preoperative status throughout the 12-month follow-up in both groups .
RESULTS	Moreover , the outcomes between the groups were comparable at all follow-up points .
RESULTS	Endothelial cell-count was stable .
RESULTS	Postoperative pain length was shorter in group 1 ( P < 0.001 ) .
CONCLUSIONS	`` Epithelium-on '' and `` epithelium-off '' CXL using hypotonic 0.5 % riboflavin were equally safe and effective in stabilization of keratoconus .
CONCLUSIONS	Topography and aberrometry outcomes in both groups failed to show any significant improvements .
CONCLUSIONS	This study is registered at ClinicalTrials.gov : NCT01181219 .

###25332243
OBJECTIVE	High-dose interferon ( IFN ) for 1 year ( HDI ) is the US Food and Drug Administration-approved adjuvant therapy for patients with high-risk melanoma .
OBJECTIVE	Efforts to modify IFN dose and schedule have not improved efficacy .
OBJECTIVE	We sought to determine whether a shorter course of biochemotherapy would be more effective .
METHODS	S0008 ( S0008 : Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma ) was an Intergroup phase III trial that enrolled high-risk patients ( stage IIIA-N2a through IIIC-N3 ) , randomly assigning them to receive either HDI or biochemotherapy consisting of dacarbazine , cisplatin , vinblastine , interleukin-2 , IFN alfa-2b ( IFN -- 2b ) and granulocyte colony-stimulating factor given every 21 days for three cycles .
METHODS	Coprimary end points were relapse-free survival ( RFS ) and overall survival ( OS ) .
RESULTS	In all , 432 patients were enrolled .
RESULTS	Grade 3 and 4 adverse events occurred in 57 % and 7 % of HDI patients and 36 % and 40 % of biochemotherapy patients , respectively .
RESULTS	At a median follow-up of 7.2 years , biochemotherapy improved RFS ( hazard ratio [ HR ] , 0.75 ; 95 % CI , 0.58 to 0.97 ; P = .015 ) , with a median RFS of 4.0 years ( 95 % CI , 1.9 years to not reached [ NR ] ) versus 1.9 years for HDI ( 95 % CI , 1.2 to 2.8 years ) and a 5-year RFS of 48 % versus 39 % .
RESULTS	Median OS was not different ( HR , 0.98 ; 95 % CI , 0.74 to 1.31 ; P = .55 ) , with a median OS of 9.9 years ( 95 % CI , 4.62 years to NR ) for biochemotherapy versus 6.7 years ( 95 % CI , 4.5 years to NR ) for HDI and a 5-year OS of 56 % for both arms .
CONCLUSIONS	Biochemotherapy is a shorter , alternative adjuvant treatment for patients with high-risk melanoma that provides statistically significant improvement in RFS but no difference in OS and more toxicity compared with HDI .

###25204320
BACKGROUND	Screen-based activities , such as watching television ( TV ) , playing video games , and using computers , are common sedentary behaviors among young people and have been linked with increased energy intake and overweight .
BACKGROUND	Previous home-based sedentary behaviour interventions have been limited by focusing primarily on the child , small sample sizes , and short follow-up periods .
BACKGROUND	The SWITCH ( Screen-Time Weight-loss Intervention Targeting Children at Home ) study aimed to determine the effect of a home-based , family-delivered intervention to reduce screen-based sedentary behaviour on body composition , sedentary behaviour , physical activity , and diet over 24 weeks in overweight and obese children .
METHODS	A two-arm , parallel , randomized controlled trial was conducted .
METHODS	Children and their primary caregiver living in Auckland , New Zealand were recruited via schools , community centres , and word of mouth .
METHODS	The intervention , delivered over 20 weeks , consisted of a face-to-face meeting with the parent/caregiver and the child to deliver intervention content , which focused on training and educating them to use a wide range of strategies designed to reduce their child 's screen time .
METHODS	Families were given Time Machine TV monitoring devices to assist with allocating screen time , activity packages to promote alternative activities , online support via a website , and monthly newsletters .
METHODS	Control participants were given the intervention material on completion of follow-up .
METHODS	The primary outcome was change in children 's BMI z-score from baseline to 24 weeks .
RESULTS	Children ( n = 251 ) aged 9-12 years and their primary caregiver were randomized to receive the SWITCH intervention ( n = 127 ) or no intervention ( controls ; n = 124 ) .
RESULTS	There was no significant difference in change of zBMI between the intervention and control groups , although a favorable trend was observed ( -0.016 ; 95 % CI : -0.084 , 0.051 ; p = 0.64 ) .
RESULTS	There were also no significant differences on secondary outcomes , except for a trend towards increased children 's moderate intensity physical activity in the intervention group ( 24.3 min/d ; 95 % CI : -0.94 , 49.51 ; p = 0.06 ) .
CONCLUSIONS	A home-based , family-delivered intervention to reduce all leisure-time screen use had no significant effect on screen-time or on BMI at 24 weeks in overweight and obese children aged 9-12 years .
BACKGROUND	Australian New Zealand Clinical Trials RegistryWebsite : http://www.anzctr.org.au
BACKGROUND	ACTRN12611000164998 .

###24317968
BACKGROUND	We have previously reported that 1year of supervised resistance + impact training stopped bone loss and built muscle strength in older breast cancer survivors .
BACKGROUND	The purpose of this study was to determine whether these benefits persisted 1year after completion of the intervention .
METHODS	Sixty-seven women from the original trial completed baseline and post-intervention body composition and muscle strength tests , and 44 women were available 1year later for follow-up assessments .
METHODS	Bone mineral density ( grams per square centimeter ) of the hip and spine , muscle mass ( kilograms ) , and fat mass ( kilograms ) were measured by dual-energy X-ray absorptiometry and maximal upper and lower body strength were measured by one-repetition maximum tests ( kilograms ) .
METHODS	We compared between group changes across baseline ( pre-intervention ) , 1 ( post-intervention ) , and 2years ( 1year follow up ) on study outcomes using repeated-measures analysis of covariance , adjusting for age .
RESULTS	Significant group by time interactions were found for spine bone mineral density ( BMD ) ( p < 0.01 ) and lower body muscle strength ( p < 0.05 ) , with a trend for upper body muscle strength ( p = 0.05 ) .
RESULTS	Spine BMD remained stable across intervention and follow-up periods in exercisers compared with continuous losses in controls across 1 - and 2-year periods .
RESULTS	In contrast , lower body strength increased in exercisers across the intervention , but decreased to near-baseline levels during follow-up compared with no change over either time period in controls .
CONCLUSIONS	Our data suggest that spine BMD can be preserved in older breast cancer survivors even after formal exercise training stops ; however , muscle strength is not similarly maintained and may require continued participation in a supervised exercise program .
CONCLUSIONS	Exercise programs aimed at improving musculoskeletal health should be considered in the long-term care plan for breast cancer survivors .

###25617202
BACKGROUND	Control of cervical cancer in developing countries has been hampered by a failure to achieve high screening uptake .
BACKGROUND	HPV DNA self-collection could increase screening coverage , but implementation of this technology is difficult in countries of middle and low income .
BACKGROUND	We investigated whether offering HPV DNA self-collection during routine home visits by community health workers could increase cervical screening .
METHODS	We did a population-based cluster-randomised trial in the province of Jujuy , Argentina , between July 1 , 2012 , and Dec 31 , 2012 .
METHODS	Community health workers were eligible for the study if they scored highly on a performance score , and women aged 30 years or older were eligible for enrolment by the community health worker .
METHODS	200 community health workers were randomly allocated in a 1:1 ratio to either the intervention group ( offered women the chance to self-collect a sample for cervical screening during a home visit ) or the control group ( advised women to attend a health clinic for cervical screening ) .
METHODS	The primary outcome was screening uptake , measured as the proportion of women having any HPV screening test within 6 months of the community health worker visit .
METHODS	Analysis was by intention to treat .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT02095561 .
RESULTS	100 community health workers were randomly allocated to the intervention group and 100 were assigned to the control group ; nine did not take part .
RESULTS	191 participating community health workers ( 94 in the intervention group and 97 in the control group ) initially contacted 7650 women ; of 3632 women contacted by community health workers in the intervention group , 3049 agreed to participate ; of 4018 women contacted by community health workers in the control group , 2964 agreed to participate .
RESULTS	2618 ( 86 % ) of 3049 women in the intervention group had any HPV test within 6 months of the community health worker visit , compared with 599 ( 20 % ) of 2964 in the control group ( risk ratio 402 , 95 % CI 344-471 ) .
CONCLUSIONS	Offering self-collection of samples for HPV testing by community health workers during home visits resulted in a four-fold increase in screening uptake , showing that this strategy is effective to improve cervical screening coverage .
CONCLUSIONS	This intervention reduces women 's barriers to screening and results in a substantial and rapid increase in coverage .
CONCLUSIONS	Our findings suggest that HPV testing could be extended throughout Argentina and in other countries to increase cervical screening coverage .
BACKGROUND	Instituto Nacional del Cncer ( Argentina ) .

###24419419
BACKGROUND	Second-line chemotherapy for advanced non-small cell lung cancer ( NSCLC ) improves survival modestly but new strategies are needed .
BACKGROUND	This trial was designed to evaluate an antivascular endothelial growth factor strategy with or without standard chemotherapy in previously treated NSCLC .
METHODS	Patients with stage IIIB/IV NSCLC with performance status 0 to 1 progressive after first-line chemotherapy were eligible for randomization to pemetrexed , sunitinib , or the combination .
METHODS	Patients were stratified by performance status , stage , and sex .
METHODS	Primary objective was 18-week progression-free survival ( PFS ) rate ; secondary objectives included response , overall survival ( OS ) , and toxicity .
METHODS	Target accrual was 225 .
METHODS	The study was terminated early because of decreasing accrual rates .
RESULTS	Between April 2008 and September 2011 , 130 patients were registered and randomized ; of this , 125 patients were treated .
RESULTS	Baseline characteristics in the three arms were well balanced .
RESULTS	Toxicity was higher in the sunitinib-containing arms .
RESULTS	The 18-week PFS rate in the pemetrexed , sunitinib , and combination arms was 54 % ( 95 % confidence interval [ CI ] , 40-71 ) , 37 % ( 95 % CI , 25-54 ) , and 48 % ( 95 % CI , 35-66 ) , respectively ( p = 0.25 ) .
RESULTS	Median PFS in the pemetrexed , sunitinib , and combination arms in months was 4.9 ( 2.1-8 .8 ) , 3.3 ( 2.3-4 .2 ) , and 3.7 ( 2.5-5 .8 ) , respectively ( p = 0.18 ) .
RESULTS	There was an overall statistically significant difference in OS between the three arms : median OS in months was 10.5 ( 8.3-20 .2 ) for pemetrexed , 8.0 ( 6.8-13 .5 ) for sunitinib , and 6.7 ( 4.1-10 .1 ) for the combination ( p = 0.03 ) .
CONCLUSIONS	Pemetrexed had a superior toxicity profile to either sunitinib or the combination of pemetrexed and sunitinib .
CONCLUSIONS	The 18-week PFS rate was not significantly different between the arms .
CONCLUSIONS	OS was significantly better with pemetrexed alone compared with the two sunitinib-containing arms , with the doublet performing worst for OS .

###25079306
OBJECTIVE	Ex-PRESS shunt is an alternative filtration procedure to trabeculectomy .
OBJECTIVE	This study aimed to compare the 1-year cost differences between the 2 operations .
METHODS	Subjects were enrolled in a randomized controlled trial comparing Ex-PRESS to trabeculectomy .
METHODS	Surgical cost difference and 1-year postoperative costs ( follow-up visits , additional procedures , and medications ) were determined and compared .
METHODS	The 95 % confidence interval of incremental cost-effectiveness ratio was estimated using bootstrap method .
RESULTS	Forty-three subjects with 1-year follow-up were included .
RESULTS	Success rate was not significantly different for Ex-PRESS ( 65 % ) versus trabeculectomy ( 55 % , P = 0.49 ) .
RESULTS	Ex-PRESS had a net surgical cost of $ 956 greater than trabeculectomy .
RESULTS	There was no significant difference in the overall postoperative cost [ median ( interquartile range ) ; $ 485 ( 337 , 822 ) vs. $ 609 ( 387 , 820 ) , P = 0.78 ] , cost of follow-up visits [ $ 303 ( 275 , 358 ) vs. $ 317 ( 275 , 385 ) , P = 0.75 ] , additional procedures [ $ 182 ( 0 , 365 ) vs. $ 182 ( 0 , 365 ) , P = 0.69 ] , or glaucoma medication [ $ 0 ( 0 , 68 ) vs. $ 0 ( 0 , 90 ) , P = 0.8 ] for Ex-PRESS versus trabeculectomy , respectively .
RESULTS	The overall 1-year cost was significantly greater for Ex-PRESS and the incremental cost-effectiveness ratio was $ 9625 ( 95 % confidence interval , $ 2435-548 ,084 ) .
CONCLUSIONS	Ex-PRESS is associated with greater surgical cost compared with trabeculectomy .
CONCLUSIONS	This needs to be considered in conjunction with efficacy and safety if Ex-PRESS is to supersede trabeculectomy .

###24839948
OBJECTIVE	Midostaurin , a multitargeted tyrosine kinase inhibitor , is primarily metabolized by CYP3A4 .
OBJECTIVE	This midostaurin drug-drug interaction study assessed the dynamic response and clinical usefulness of urinary 6-hydroxycortisol to cortisol ratio ( 6CR ) and plasma 4-hydroxycholesterol ( 4HC ) for monitoring CYP3A4 activity in the presence or absence of rifampicin , a strong CYP3A4 inducer .
METHODS	Forty healthy adults were randomized into groups for either placebo or treatment with rifampicin 600mg QD for 14days .
METHODS	All participants received midostaurin 50mg on day 9 .
METHODS	Midostaurin plasma pharmacokinetic parameters were assessed .
METHODS	Urinary 6CR and plasma 4HC levels were measured on days 1 , 9 , 11 , and 15 .
RESULTS	Both markers remained stable over time in the control group and increased significantly in the rifampicin group .
RESULTS	In the rifampicin group , the median increases ( vs day 1 ) on days 9 , 11 , and 15 were 4.1 - , 5.2 - , and 4.7-fold , respectively , for 6CR and 3.4 - , 4.1 - , and 4.7-fold , respectively , for 4HC .
RESULTS	Inter - and intrasubject variabilities in the control group were 45.6 % and 30.5 % , respectively , for 6CR , and 33.8 % and 7.5 % , respectively , for 4HC .
RESULTS	Baseline midostaurin area under the concentration-time curve ( AUC ) correlated with 4HC levels ( = -0.72 ; P = .003 ) , but not with 6CR ( = 0.0925 ; P = .6981 ) .
CONCLUSIONS	Both 6CR and 4HC levels showed a good dynamic response range upon strong CYP3A4 induction with rifampicin .
CONCLUSIONS	Because of lower inter - and intrasubject variability , 4HC appeared more reliable and better predictive of CYP3A4 activity compared with 6CR .
CONCLUSIONS	The data from our study further support the clinical utility of these biomarkers .

###24717956
BACKGROUND	Chronic rhinosinusitis ( CRS ) is an inflammatory process that causes different clinical symptoms : nasal blockage and congestion , posterior and anterior nasal drip , and smell disorder ranging from reduced olfaction ( hyposmia ) to complete loss of smell ( anosmia ) .
BACKGROUND	It has been suggested that mechanical blockage of olfactory clef after polypectomy is responsible for the persistent impairment of olfaction in some cases .
BACKGROUND	The aim of this study was to evaluate the efficacy of application of steroids at the olfactory cleft in improving olfactory function in patients who underwent sinus surgery .
METHODS	A double-blind , randomized controlled trial was conducted in Yazd , Iran , between March and December 2012 .
METHODS	Eligible patients who had CRS with polyposis and underwent functional endoscopic sinus surgery were recruited .
METHODS	An absorbable gelatin dressing combined with triamcinolone ( case ) or normal saline ( control ) was applied at the site of surgery .
METHODS	Olfaction was assessed by butanol threshold tests before and 8 weeks after surgery .
RESULTS	A total of 60 patients were enrolled into the study and were equally divided into triamcinolone and control groups .
RESULTS	Subjects in both arms of trial experienced augmentation of smell function throughout the study ; however , patients who received triamcinolone had better improvement after 8 weeks ( p = 0.007 ) .
RESULTS	Complete remission rate was 100 % in the triamcinolone group and the corresponding figure was 76 % in the control group .
CONCLUSIONS	We suggest that application of triamcinolone at the olfactory cleft can boost the effect of surgery in restoring olfactory function .

###24925372
BACKGROUND	Previous pharmacokinetic trials suggested that 40 mg subcutaneous enoxaparin once daily provided inadequate thromboprophylaxis for intensive care unit patients .
BACKGROUND	Critically ill patients with acute kidney injury are at increased risk of venous thromboembolism and yet are often excluded from these trials .
BACKGROUND	We hypothesized that for critically ill patients with acute kidney injury receiving continuous renal replacement therapy , a dose of 1 mg/kg enoxaparin subcutaneously once daily would improve thromboprophylaxis without increasing the risk of bleeding .
BACKGROUND	In addition , we seek to utilize urine output prior to discontinuing dialysis , and low neutrophil gelatinase-associated lipocalin in dialysis-free intervals , as markers of renal recovery .
METHODS	In a multicenter , double-blind randomized controlled trial in progress at three intensive care units across Denmark , we randomly assign eligible critically ill adults with acute kidney injury into a treatment ( 1 mg/kg enoxaparin subcutaneously once daily ) or control arm ( 40 mg enoxaparin subcutaneously once daily ) upon commencement of continuous renal replacement therapy.We calculated that with 133 patients in each group , the study would have 80 % power to show a 40 % reduction in the relative risk of venous thromboembolism with 1 mg/kg enoxaparin , at a two-sided alpha level of 0.05 .
METHODS	An interim analysis will be conducted after the first 67 patients have been included in each group.Enrolment began in March 2013 , and will continue for two years .
METHODS	The primary outcome is the occurrence of venous thromboembolism .
METHODS	Secondary outcomes include anti-factor Xa activity , bleeding , heparin-induced thrombocytopenia , filter lifespan , length of stay , ventilator free days , and mortality .
METHODS	We will also monitor neutrophil gelatinase-associated lipocalin and urine volume to determine whether they can be used as prognostic factors for renal recovery .
CONCLUSIONS	Critically ill unit patients with acute kidney injury present a particular challenge in the provision of thromboprophylaxis .
CONCLUSIONS	This study hopes to add to the growing evidence that the existing recommendation of 40 mg enoxaparin is inadequate and that 1 mg/kg is both safe and effective for thromboprophylaxis.In addition , the study seeks to identify predictors of renal recovery allowing for the proper utilization of resources .
BACKGROUND	EU Clinical Trials Register : EudraCT number : 2012-004368-23 , 25 September 2012 .

###24682502
BACKGROUND	The nucleus accumbens ( NAc ) works as a key brain structure of the reward system , in which reward-related neural activity is well correlated with dopamine release from mesolimbic dopaminergic neurons .
OBJECTIVE	Since modafinil can modulate dopaminergic transmission through re-uptake inhibition of dopamine , we investigated whether modafinil affects the reward-related brain activity in the NAc in healthy subjects .
METHODS	Twenty healthy participants underwent two series of functional magnetic resonance imaging while performing monetary incentive delay task in which they were cued to anticipate and respond to a rapidly presented target to gain or avoid losing varying amounts of money , under modafinil or placebo condition .
METHODS	Blood oxygenation-level dependent ( BOLD ) activation signals during gain and loss anticipations were analyzed in the NAc as an a priori region of interest as well as the whole brain .
RESULTS	Modafinil significantly changed subjective feelings toward positive ones .
RESULTS	The activation of BOLD signals was observed during gain anticipation under the placebo and modafinil conditions in the left and bilateral NAc , respectively .
RESULTS	The modafinil condition showed significantly higher BOLD signal change at the highest gain ( +500 ) cue compared to the placebo condition .
CONCLUSIONS	The present study showed that modafinil affects reward processing in the NAc in healthy subjects through enhancing more positive anticipation , and it may provide a basis for the use of this drug for treating anhedonia observed in psychiatric disorders .

###24834935
CONCLUSIONS	Risk factors associated with increased carriage rates are the same in children with recurrent acute otitis media ( rAOM ) as in healthy children .
CONCLUSIONS	These are also known to be risk factors for the development of AOM itself .
OBJECTIVE	The aim of this study was to describe risk factors for nasopharyngeal carriage in a cohort of young children at high risk of developing rAOM .
METHODS	Children with an onset of AOM before 6 months of age , indicating an 80 % risk of developing rAOM , were enrolled in a vaccination trial on heptavalent PCV .
METHODS	These children were monitored for 3 years during healthy and AOM periods with nasopharyngeal cultures , physical examinations , and questionnaires .
RESULTS	A total of 109 children were included at a mean age of 5 months ; 105 were followed for 3 years , 89 ( 82 % ) of whom developed rAOM .
RESULTS	Risk factors associated with increased carriage of all major AOM pathogens were age < 2 years , concurrent AOM , and fulfilment of rAOM criteria .
RESULTS	Having siblings in day care was associated with increased carriage of Streptococcus pneumoniae and Haemophilus influenzae , recent antibiotic treatment was associated with H. influenzae and Moraxella catarrhalis carriage , and winter season was associated with M. catarrhalis carriage alone .

###25815454
BACKGROUND	To compare surgical pleth index ( SPI ) - guided analgesia with conventional analgesia by evaluating intraoperative analgesic requirements , postoperative pain , and emergence agitation in children .
METHODS	This study was designed as a parallel , two-arm , double-blind , randomized controlled trial .
METHODS	Forty-five children undergoing elective adenotonsillectomy were randomly allocated to SPI-guided group ( SPI-guided analgesia group , n = 21 ) or control group ( conventional analgesia group , n = 24 ) .
METHODS	Anesthesia was maintained with sevoflurane 2 to 3 vol % in 50 % nitrous oxide and oxygen to achieve state entropy between 40 and 60 .
METHODS	Intraoperative fentanyl 0.5 g/kg was administered for the first event persisting 3 min and subsequent events persisting 5 min .
METHODS	An event was defined as an SPI over 50 ( SPI-guided group ) or a blood pressure or heart rate 20 % above the baseline ( control group ) .
METHODS	The primary outcome was intraoperative fentanyl requirement .
METHODS	Secondary outcomes included intraoperative sevoflurane consumption , postoperative emergence agitation and pain score , and postoperative rescue analgesic requirements .
RESULTS	Intraoperative fentanyl requirement was lower in SPI-guided group than in control group ( 0.43 0.53 vs. 1.73 0.59 g/kg ; P < 0.001 ) .
RESULTS	Intraoperative sevoflurane consumption was similar .
RESULTS	The proportion of patients with high emergence agitation scores ( 4 to 5 ) was greater in SPI-guided group ( 61.9 vs. 25.0 % ; P = 0.01 ) .
RESULTS	The postoperative pain score and rescue fentanyl consumption were higher in SPI-guided group ( 7 [ 4.5 ; 9 ] vs. 3 [ 2 ; 6.75 ] ; P = 0.002 ; 0.50 0.34 vs. 0.29 0.30 g/kg ; P = 0.04 ) .
CONCLUSIONS	As currently constructed , SPI does not appear to be valid in children .
CONCLUSIONS	This may be due to both differences in blood vessel distensibility and baseline increased heart rates in children versus adults .

###24498939
BACKGROUND	Anxiety and depression are common co-morbidities in patients with chronic obstructive pulmonary disease ( COPD ) .
BACKGROUND	Serious implications can result from psychological difficulties in COPD including reduced survival , lower quality of life , and reduced physical and social functioning , increased use of health care resources and are associated with unhealthy behaviours such as smoking .
BACKGROUND	Cognitive behavioural therapy ( CBT ) is a psychological intervention which is recommended for the treatment of many mental health problems including anxiety and depression .
BACKGROUND	Unfortunately access to trained CBT therapists is limited .
BACKGROUND	The aim of this study is to test the hypothesis that CBT delivered by respiratory nurses is effective in the COPD population .
BACKGROUND	In this paper the design of the Newcastle Chronic Obstructive Pulmonary Disease Cognitive Behavioural Therapy Study ( Newcastle COPD CBT Care Study ) is described .
METHODS	This is a prospective open randomised controlled trial comparing CBT with self-help leaflets .
METHODS	The primary outcome measure is the Hospital Anxiety & Depression Scale ( HADS ) - anxiety subscale .
METHODS	Secondary outcome measures include disease specific quality of life COPD Assessment Tool ( CAT ) , generic quality of life ( EQ5D ) and HADS-depression subscale .
METHODS	Patients will be followed up at three , six and 12 months following randomisation .
CONCLUSIONS	This is the first randomised controlled trial to evaluate the use of cognitive behavioural therapy undertaken by respiratory nurses .
CONCLUSIONS	Recruitment has commenced and should be complete by February 2014 .
BACKGROUND	Current Controlled Trials , ISRCTN55206395 .

###24622369
BACKGROUND	We aimed to investigate the efficacy and tolerability of empagliflozin , an oral , potent , and selective inhibitor of sodium-glucose co-transporter 2 , in patients with type 2 diabetes who had not received drug treatment in the preceding 12 weeks .
METHODS	In our multicentre , randomised , placebo-controlled , phase 3 trial , we enrolled adults ( aged 18 years ) who had not received oral or injected anti-diabetes treatment in the previous 12 weeks .
METHODS	Eligible patients had HbA1c concentrations of 7-10 % .
METHODS	We randomly allocated patients ( 1:1:1:1 ) with a computer-generated random sequence , stratified by region , HbA1c , and estimated glomerular filtration rate at screening , to placebo , empagliflozin 10 mg , empagliflozin 25 mg , or sitagliptin 100 mg once daily for 24 weeks .
METHODS	Patients and investigators were masked to treatment assignment .
METHODS	The primary endpoint was change from baseline in HbA1c at week 24 by ANCOVA in all randomly allocated patients who were treated with at least one dose of study drug and had a baseline HbA1c value .
METHODS	This study is completed and registered with ClinicalTrials.gov , number NCT01177813 .
RESULTS	Between Aug 12 , 2010 , and March 19 , 2012 , we randomly allocated 228 patients to receive placebo , 224 to receive empagliflozin 10 mg , 224 to receive empagliflozin 25 mg , and 223 to receive sitagliptin .
RESULTS	Compared with placebo , adjusted mean differences in change from baseline HbA1c at week 24 were -074 % ( 95 % CI -088 to -059 ; p < 00001 ) for empagliflozin 10 mg , -085 % ( -099 to -071 ; p < 00001 ) for empagliflozin 25 mg , and -073 % ( -088 to -059 ; p < 00001 ) for sitagliptin .
RESULTS	140 ( 61 % ) patients in the placebo group reported adverse events ( four [ 2 % ] severe and six [ 3 % ] serious ) , as did 123 ( 55 % ) patients in the empagliflozin 10 mg group ( eight [ 4 % ] severe and eight [ 4 % ] serious ) , 135 ( 60 % ) patients in the empagliflozin 25 mg group ( seven [ 3 % ] severe and five [ 2 % ] serious ) , and 119 ( 53 % ) patients in the sitagliptin group ( five [ 2 % ] severe and six [ 3 % ] serious ) .
CONCLUSIONS	Empagliflozin provides a tolerable and efficacious strategy to reduce HbA1c in patients with type 2 diabetes who had not previously received drug treatment .
BACKGROUND	Boehringer Ingelheim and Eli Lilly .

###24370154
OBJECTIVE	The purpose of this study was to prospectively evaluate the contrast enhancement , vascular depiction , image quality , and radiation dose of low-tube-voltage whole-body CT angiography ( CTA ) performed with low-concentration iodinated contrast material .
METHODS	Whole-body CTA was performed on 109 patients with a 64-MDCT scanner .
METHODS	Patients were randomized into three groups : CTA with 240-mg/mL contrast material at 80 kVp ( 240-80 group ) , 300-mg/mL at 80 kVp ( 300-80 group ) , and 370-mg/mL at 120 kVp ( 370-120 group ) .
METHODS	Signal-to-noise ratio ( SNR ) , arterial depiction , image quality , and radiation dose were assessed .
METHODS	Figure of merit was computed to normalize signal-to-noise ratio , estimated effective dose , and iodine weight .
RESULTS	In the 240-80 group , the mean load of administered iodine was 21.6 g ; for the 300-80 group , 26.8 g ; and the 370-120 group , 34.0 g ( p < 0.05 ) .
RESULTS	The ranges of mean vascular enhancement were 508-521 HU , 546-593 HU , and 435-442 HU ( p < 0.05 ) .
RESULTS	Arterial depiction and image quality were comparable for the 240-80 and 370-120 groups and were greater for the 300-80 group than the other two groups in selected arteries ( p < 0.05 ) .
RESULTS	Effective dose was higher ( p < 0.05 ) in the 370-120 group ( 2.8-5 .4 mSv ) than in the others ( 2.3-4 .3 mSv ) .
RESULTS	The figure of merit in the 240-80 group was greater than ( p < 0.05 ) or comparable to that in the 370-120 group .
CONCLUSIONS	Use of 240-mg/mL contrast material at 80 kVp seems appropriate for routine whole-body CTA and beneficial for reduction of iodine load and radiation dose , whereas use of 300-mg/mL contrast material may marginally improve delineation of selected small arteries .

###24509026
BACKGROUND	Few studies examine psychosocial factors influencing the adoption of healthy behaviors among hypertensive patients .
BACKGROUND	The effect of discrimination on health behaviors remains untested .
OBJECTIVE	To examine the influence of discrimination on adoption of healthy behaviors among low-income Black hypertensive patients .
METHODS	Black patients ( N = 930 ) in community-based primary care practices enrolled in the CAATCH trial .
METHODS	Mixed effects regressions examined associations between perceived discrimination and change in medication adherence , diet , and physical activity from baseline to 12 months , controlling for intervention , gender , age , income , and education .
RESULTS	Patients were low-income , high-school-educated , with a mean age of 57 years .
RESULTS	Greater discrimination was associated with worse diet and lower medication adherence at baseline .
RESULTS	Discrimination was associated with greater improvement in healthy eating behaviors over the course of the 12-month trial .
CONCLUSIONS	Prior exposure to discrimination was associated with unhealthy behaviors at baseline , but did not negatively influence the adoption of health behaviors over time .

###25931293
OBJECTIVE	To evaluate the efficacy of spinal needle aspiration for symptom improvement in awake patients with epiglottic abscess ( EA ) .
METHODS	Prospective randomized controlled study .
METHODS	Tertiary center .
METHODS	Twenty-two patients who were diagnosed with EA were randomly allocated to group A ( needle aspiration and antibiotics ) or group B ( antibiotics only ) .
METHODS	Patients ' characteristics , laryngoscopic findings of epiglottic swelling and arytenoid swelling by scope classification , and initial laboratory findings were analyzed .
METHODS	Needle aspiration was done under local anesthesia in awake patients using an 18-gauge spinal needle and indirect laryngoscope .
METHODS	Changes in the following symptoms during hospital stay were assessed : sore throat , hoarseness , dyspnea , odynophagia , and dysphagia .
RESULTS	Eleven patients were treated with needle aspiration and antibiotics , and 11 patients were treated with antibiotics only .
RESULTS	There was no statistically significant difference between the 2 groups regarding age , sex , white blood cell count , C-reactive protein , presenting clinical symptoms , abscess size , and scope classification at time of diagnosis .
RESULTS	Patients in both groups had significant improvement in all clinical symptoms .
RESULTS	While there were no between-group differences in improvement for any of the symptoms , the length of hospitalization was significantly lower in group A ( 4.0 1.9 days ) than in group B ( 5.7 1.2 days ) ( P = .037 ) .
CONCLUSIONS	We did not find any significant additional benefit of needle aspiration for the treatment of EA , with the exception that needle aspiration reduced the length of hospitalization .
CONCLUSIONS	Further proof with a large-scale study is needed .

###25007905
BACKGROUND	Calf vein diameters during compression with two different stocking brands are assessed as well as quality of life .
METHODS	60 subjects ( 53 female ) with painful legs were randomized to either wearing the Venotrain micro ( VM ) or the Venotrain ulcertec ( VU ) compression stocking for 2 weeks .
METHODS	All calf - veins were assessed in cross - sectional plane by Duplexsonography native and through the compression stockings .
METHODS	The diameters of 2 gastrocnemius muscle - veins ( GV ) , the short saphenous vein ( SSV ) and the posterior tibial vein ( PTV ) were compared intra - individually , with and without compression .
RESULTS	Mean diameters ( SD ) decreased significantly under compression ( p < 0.0001 ) in the standing position : in the antero-posterior ( ap ) plane of the GV by 6.5 ( 16.6 ) % under VU and 8.2 ( 16.5 ) % under VM , in the SSV 9.7 ( 15.8 ) % under VU and 5.7 ( 19.2 ) % under VM .
RESULTS	No significant change ( p = 0.48 ) was seen in the PTV .
RESULTS	In the prone position the relative ap - diameter changes in the medial GV were significantly smaller for the VM ( 37.5 51.0 % ) compared to the VU compression stocking ( 52.4 51.8 % ) ( p = 0.016 ) .
RESULTS	The quality of life assessment scores improved significantly for the VU - and the VM - compression stocking .
RESULTS	Venous diameters did not correlate with quality of life scores .
CONCLUSIONS	Intra - individually tested the calf muscle vein diameters decrease under compression , more pronounced in the prone than in the standing position .
CONCLUSIONS	In the ankle area the PTV does not decrease in standing subjects .
CONCLUSIONS	Quality of life assessed increases for both compression stockings .

###25084070
BACKGROUND	Results of previous studies suggest that - adrenoreceptor activation may augment pain , and that - adrenoreceptor antagonists may be effective in reducing pain , particularly in individuals not homozygous for the catechol-O-methyltransferase ( COMT ) high-activity haplotype .
METHODS	Consenting patients admitted for thermal burn injury at participating burn centers were genotyped ; those who were not high-activity COMT homozygotes were randomized to propranolol 240 mg/d or placebo .
METHODS	Primary outcomes were study feasibility ( consent rate , protocol completion rate ) and pain scores on study days 5 to 19 .
METHODS	Secondary outcomes assessed pain and posttraumatic stress disorder symptoms 6 weeks postinjury .
RESULTS	Seventy-seven percent ( 61/79 ) of eligible patients were consented and genotyped , and 77 % ( 47/61 ) were genotype eligible and randomized .
RESULTS	Ninety-one percent ( 43/47 ) tolerated study drug and completed primary outcome assessments .
RESULTS	In intention-to-treat and per-protocol analyses , patients randomized to propranolol had worse pain scores on study days 5 to 19 .
CONCLUSIONS	Genotype-specific pain medication interventions are feasible in hospitalized burn patients .
CONCLUSIONS	Propranolol is unlikely to be a useful analgesic during the first few weeks after burn injury .

###25458558
BACKGROUND	New treatment options are needed for second-line therapy in patients with NSCLC .
METHODS	This was a phase Ib/II study in patients with nonsquamous NSCLC in whom 1 previous platinum-based chemotherapy regimen had failed .
METHODS	Fifteen patients were enrolled in a dose escalation of eribulin mesylate in combination with pemetrexed ( E+P ) .
METHODS	In phase II ( n = 80 ) , E+P at the maximum tolerated dose was compared with P.
RESULTS	In phase Ib , the maximum tolerated dose of E+P was defined as eribulin 0.9 mg/m ( 2 ) with pemetrexed ( 500mg/m ( 2 ) ) each on day 1 of a 21-day cycle .
RESULTS	In phase II , adverse events were comparable between groups .
RESULTS	PFS and OSwere similar between treatment groups .
RESULTS	Median PFS was 21.4 weeks for E+P ( n = 26 ; 95 % confidence interval [ CI ] , 12.7-39 .6 ) and 23.4 weeks for P ( n = 29 ; 95 % CI , 17.1-29 .9 ) , with a hazard ratio of 1.0 ( 95 % CI , 0.6-1 .7 ) .
CONCLUSIONS	During phase Ib , E+P was tolerated only at a markedly lower dosing intensity relative to the eribulin monotherapy regimen approved for breast cancer and used in phase II studies of NSCLC .
CONCLUSIONS	At the selected phase II dosing regimen , E+P was generally safe and well tolerated but provided no therapeutic advantage for the second-line treatment of locally advanced or metastatic nonsquamous NSCLC .

###24329943
OBJECTIVE	To assess the effectiveness of application of health locus of control in pregnant women for prevention of postpartum depression in Iran .
BACKGROUND	Nearly 10-15 % of women suffer postnatal depression by the end of the second week after delivery , which creates problems in caring for the child that may affect child 's future learning and concentration .
METHODS	Pre-post experimental design .
METHODS	Two hundred and thirty volunteer women were randomly divided into experimental and control groups .
METHODS	The data collection tools included a demographic questionnaire , the Multidimensional Health Locus of Control Scale and the Edinburg Depression Scale .
METHODS	Based on the associations found in the pretest , intervention programme was planned and carried out in the focused group discussion method .
METHODS	Data were collected after the end of scheduled sessions , immediately and one month later .
METHODS	The data were analysed with SPSS-16 using statistical methods including anova , chi-square test , Student 's t-test and paired t-test .
RESULTS	Chance health locus of control significantly reduced and internal health locus of control significantly increased , immediately after intervention .
RESULTS	Also , a month after intervention , a significant difference was observed between the two groups in reducing postpartum depression .
CONCLUSIONS	The planned participatory intervention led to empowerment and increased awareness and internalisation of health control beliefs and less tendency towards external health control beliefs , especially chance , improvement in general health leading to improved psychological health for prevention of postpartum depression in mothers .
CONCLUSIONS	Clinicians might assess chance and internal health locus of control to identify the women at risk of developing depression during their pregnancy and to develop prevention and treatment plans .

###25282200
OBJECTIVE	To examine adherence to , satisfaction with , and preliminary efficacy of mobile phone short message service ( SMS ) to promote health behaviors in school-aged children .
METHODS	A total of 49 children ( aged 8-10 years ) were randomized by school classes into a monitoring vs no-monitoring group .
METHODS	All children participated in 2 educational group sessions that focused on health behaviors : the advantages of increasing fruit and vegetable consumption and physical activity , and decreasing screen time .
METHODS	The monitoring group also reported daily behavior using SMS and received supportive feedback for 8 weeks .
RESULTS	Children submitted 61 % of the required SMS , which indicated good adherence to the intervention .
RESULTS	A number of children ( 95 % ) reported being satisfied with the program .
RESULTS	Analyses of covariance indicated increase in fruit and vegetable consumption ( [ 2 ] = 7.27 ; P < .05 ) and a decrease in screen time ( [ 2 ] = 6.79 ; P < .05 ) .
CONCLUSIONS	The current SMS intervention was a useful tool to monitor and promote health behaviors in children .

###24380388
BACKGROUND	Thrombosis has been associated to some diseases like hyperadrenocorticism ( HAC ) .
BACKGROUND	Several drugs can alter the balance , such as the corticosteroid prednisone , used mainly for its anti-inflammatory and immunosuppressive effects .
BACKGROUND	It is known that hypercortisolism can stimulate thrombi formation by increasing coagulation factors and decreasing fibrinolysis .
BACKGROUND	However it is not known how prednisone administration affects hemostasis in dogs and if it is dose dependent .
BACKGROUND	The aim of this study , therefore , was to demonstrate the effects of prednisone administration on dogs ' hemostatic profile .
RESULTS	Significant decrease of antithrombin levels was observed in both groups ( anti-inflammatory and immunosuppressive doses ) after 15days of treatment .
RESULTS	An increase of platelet aggregation was observed in dogs receiving immunosuppressive doses of prednisone ( Group II ) .
CONCLUSIONS	From the results obtained in our study , it is not possible to infer that hypercortisolism can increase the thromboembolic risk , despite the decreased anticoagulant factors ( antithrombin levels ) .

###24762109
BACKGROUND	The optimal approach to estrogen replacement in girls with Turner syndrome has not been determined .
OBJECTIVE	The aim of the study was to assess the effects of an individualized regimen of low-dose ethinyl estradiol ( EE2 ) during childhood from as early as age 5 , followed by a pubertal induction regimen starting after age 12 and escalating to full replacement over 4 years .
METHODS	This study was a prospective , randomized , double-blind , placebo-controlled clinical trial .
METHODS	The study was conducted at two US pediatric endocrine centers .
METHODS	Girls with Turner syndrome ( n = 149 ) , aged 5.0-12 .5 years , were enrolled ; data from 123 girls were analyzable for pubertal onset .
METHODS	Interventions comprised placebo or recombinant GH injections three times a week , with daily oral placebo or oral EE2 during childhood ( 25 ng/kg/d , ages 5-8 y ; 50 ng/kg/d , ages > 8-12 y ) ; after age 12 , all patients received escalating EE2 starting at a nominal dosage of 100 ng/kg/d .
METHODS	Placebo/EE2 dosages were reduced by 50 % for breast development before age 12 years , vaginal bleeding before age 14 years , or undue advance in bone age .
METHODS	The main outcome measures for this report were median ages at Tanner breast stage 2 , median age at menarche , and tempo of puberty ( Tanner 2 to menarche ) .
METHODS	Patterns of gonadotropin secretion and impact of childhood EE2 on gonadotropins also were assessed .
RESULTS	Compared with recipients of oral placebo ( n = 62 ) , girls who received childhood low-dose EE2 ( n = 61 ) had significantly earlier thelarche ( median , 11.6 vs 12.6 y , P < 0.001 ) and slower tempo of puberty ( median , 3.3 vs 2.2 y , P = 0.003 ) ; both groups had delayed menarche ( median , 15.0 y ) .
RESULTS	Among childhood placebo recipients , girls who had spontaneous breast development before estrogen exposure had significantly lower median FSH values than girls who did not .
CONCLUSIONS	In addition to previously reported effects on cognitive measures and GH-mediated height gain , childhood estrogen replacement significantly normalized the onset and tempo of puberty .
CONCLUSIONS	Childhood low-dose estrogen replacement should be considered for girls with Turner syndrome .

###24838406
OBJECTIVE	In asthma and other diseases , vitamin D insufficiency is associated with adverse outcomes .
OBJECTIVE	It is not known if supplementing inhaled corticosteroids with oral vitamin D3 improves outcomes in patients with asthma and vitamin D insufficiency .
OBJECTIVE	To evaluate if vitamin D supplementation would improve the clinical efficacy of inhaled corticosteroids in patients with symptomatic asthma and lower vitamin D levels .
METHODS	The VIDA ( Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma ) randomized , double-blind , parallel , placebo-controlled trial studying adult patients with symptomatic asthma and a serum 25-hydroxyvitamin D level of less than 30 ng/mL was conducted across 9 academic US medical centers in the National Heart , Lung , and Blood Institute 's AsthmaNet network , with enrollment starting in April 2011 and follow-up complete by January 2014 .
METHODS	After a run-in period that included treatment with an inhaled corticosteroid , 408 patients were randomized .
METHODS	Oral vitamin D3 ( 100,000 IU once , then 4000 IU/d for 28 weeks ; n = 201 ) or placebo ( n = 207 ) was added to inhaled ciclesonide ( 320 g/d ) .
METHODS	If asthma control was achieved after 12 weeks , ciclesonide was tapered to 160 g/d for 8 weeks , then to 80 g/d for 8 weeks if asthma control was maintained .
METHODS	The primary outcome was time to first asthma treatment failure ( a composite outcome of decline in lung function and increases in use of - agonists , systemic corticosteroids , and health care ) .
RESULTS	Treatment with vitamin D3 did not alter the rate of first treatment failure during 28 weeks ( 28 % [ 95 % CI , 21 % -34 % ] with vitamin D3 vs 29 % [ 95 % CI , 23 % -35 % ] with placebo ; adjusted hazard ratio , 0.9 [ 95 % CI , 0.6-1 .3 ] ) .
RESULTS	Of 14 prespecified secondary outcomes , 9 were analyzed , including asthma exacerbation ; of those 9 , the only statistically significant outcome was a small difference in the overall dose of ciclesonide required to maintain asthma control ( 111.3 g/d [ 95 % CI , 102.2-120 .4 g/d ] in the vitamin D3 group vs 126.2 g/d [ 95 % CI , 117.2-135 .3 g/d ] in the placebo group ; difference of 14.9 g/d [ 95 % CI , 2.1-27 .7 g/d ] ) .
CONCLUSIONS	Vitamin D3 did not reduce the rate of first treatment failure or exacerbation in adults with persistent asthma and vitamin D insufficiency .
CONCLUSIONS	These findings do not support a strategy of therapeutic vitamin D3 supplementation in patients with symptomatic asthma .
BACKGROUND	clinicaltrials.gov Identifier : NCT01248065 .

###24281139
OBJECTIVE	Term small-for-gestational-age and preterm born infants have an increased prevalence of metabolic syndrome components already in childhood .
OBJECTIVE	Data in very-low-birth-weight ( VLBW ) children are limited .
OBJECTIVE	We investigated the prevalence of metabolic syndrome components in VLBW infants at 2 years of corrected age .
METHODS	We included 38 children , participating in the Neonatal Insulin Replacement Therapy in Europe ( NIRTURE ) trial , a randomized controlled trial of early insulin therapy in VLBW infants .
METHODS	Metabolic syndrome components were defined as : body mass index SDS > 2 ; blood pressure ( systolic and/or diastolic ) 90th percentile ; triglycerides 0.98 mmol/l ; high-density lipoprotein ( HDL ) cholesterol 1.03 mmol/l ; glucose 5.6 mmol/l .
RESULTS	Two children ( 5 % ) had three metabolic syndrome components , 13 children ( 34 % ) had two components , and 11 children ( 29 % ) one component .
RESULTS	63 % had raised blood pressure ( prevalence higher in boys ) , 32 % low HDL , and 30 % high triglycerides ( prevalence lower in early insulin group ) .
RESULTS	In children with body mass index SDS < 0 , insulin-treated children had higher HDL than children with standard care .
RESULTS	Systolic blood pressure was correlated with growth between term and 2 years of corrected age .
CONCLUSIONS	VLBW infants already have a high prevalence of metabolic syndrome components at 2 years of corrected age .
CONCLUSIONS	Early insulin treatment could have long-term benefits for some of these components .

###25607903
BACKGROUND	Hyperpigmentation is a common concern and has many causes including lentigines and melasma .
BACKGROUND	Currently available topical products for hyperpigmentation are limited by their potential for irritation , lack of demonstrated efficacy or regulatory concerns .
OBJECTIVE	To compare the efficacy of a new skin lightening product with and without iontophoresis to a known effective product ( tretinoin ) and placebo on hyperpigmentation caused by lentigines and/or melasma .
OBJECTIVE	Secondary objectives included an assessment of the product 's effects on the appearance of rhytides and roughness .
METHODS	Eighty subjects were randomized into one of four treatment groups : proprietary lightening product , proprietary lightening product with iontophoresis , tretinoin 0.05 % cream , or vehicle control .
METHODS	Seventy-four subjects completed all study visits .
METHODS	Blinded assessments of subjects were performed at each visit under ambient and Wood 's light .
RESULTS	The proprietary skin lightening product improved facial hyperpigmentation versus placebo under ambient light ( P = 0.05 ) and Wood 's lamp ( P = 0.01 ) examination .
RESULTS	Tretinoin also improved facial hyperpigmentation versus placebo under Wood 's lamp ( P = 0.01 ) .
RESULTS	The proprietary product was better tolerated than tretinoin , with fewer subject reported side effects .
CONCLUSIONS	The investigational product was effective and may be better tolerated than tretinoin cream .

###24602411
BACKGROUND	Pain is a troublesome non-motor symptom of Parkinson 's disease ( PD ) .
BACKGROUND	The RECOVER ( Randomized Evaluation of the 24-hour Coverage : Efficacy of Rotigotine ; Clintrials.gov : NCT00474058 ) study demonstrated significant improvements in early-morning motor function ( UPDRS III ) and sleep disturbances ( PDSS-2 ) with rotigotine transdermal system .
BACKGROUND	Improvements were also reported on a Likert pain scale ( measuring any type of pain ) .
BACKGROUND	This post hoc analysis of RECOVER further evaluates the effect of rotigotine on pain , and whether improvements in pain may be attributable to benefits in motor function or sleep disturbance .
METHODS	PD patients with unsatisfactory early-morning motor impairment were randomized to optimal-dose ( up to 16 mg/24 h ) rotigotine or placebo , maintained for 4 weeks .
METHODS	Pain was assessed in the early-morning using an 11-point Likert pain scale ( rated average severity of pain ( of any type ) over the preceding 12 hours from 0 [ no pain ] to 10 [ worst pain ever experienced ] ) .
METHODS	Post hoc analyses for patients reporting ` any ' pain ( pain score 1 ) at baseline , and subgroups reporting ` mild ' ( score 1-3 ) , and ` moderate-to-severe ' pain ( score 4 ) were performed .
METHODS	Likert pain scale change from baseline in rotigotine-treated patients was further analyzed based on a UPDRS III/PDSS -2 responder analysis ( a responder defined as showing a 30 % reduction in early morning UPDRS III total score or PDSS-2 total score ) .
METHODS	As post hoc analyses , all p values presented are exploratory .
RESULTS	Of 267 patients with Likert pain data ( 178 rotigotine , 89 placebo ) , 187 ( 70 % ) reported ` any ' pain ; of these 87 ( 33 % ) reported ` mild ' , and 100 ( 37 % ) ` moderate-to-severe ' pain .
RESULTS	Change from baseline pain scores decreased with rotigotine compared with placebo in patients with ` any ' pain ( -0.88 [ 95 % CI : -1.56 , -0.19 ] , p = 0.013 ) , and in the subgroup with ` moderate-to-severe ' pain ( -1.38 [ -2.44 , -0.31 ] , p = 0.012 ) .
RESULTS	UPDRS III or PDSS-2 responders showed greater improvement in pain than non-responders .
CONCLUSIONS	The results from this post hoc analysis of the RECOVER study suggest that pain was improved in patients with PD treated with rotigotine ; this may be partly attributable to benefits in motor function and sleep disturbances .
CONCLUSIONS	Prospective studies are warranted to investigate this potential benefit and the clinical relevance of these findings .

###24401240
OBJECTIVE	The aim of the study was to determine if a high salt meal containing 65 mmol Na causes a rise in sodium concentrations and a reduction in plasma nitrate/nitrite concentrations ( an index of nitric oxide production ) .
OBJECTIVE	Secondary aims were to determine the effects of a high salt meal on augmentation index ( AIx ) a measure of arterial stiffness and markers of endothelial function .
RESULTS	In a randomised cross-over study 16 healthy normotensive adults consumed a low sodium soup containing 5 mmol Na and a high sodium soup containing 65 mmol Na .
RESULTS	Sodium , plasma nitrate/nitrite , endothelin-1 ( ET-1 ) , C-reactive protein ( CRP ) , vasopressin ( AVP ) and atrial natriuretic peptide ( ANP ) concentrations before and every 30 min after the soup for 2 h. Blood pressure ( BP ) and AI were also measured at these time points .
RESULTS	There were significant increases in serum sodium , osmolality and chloride in response to the high sodium meal .
RESULTS	However plasma nitrate/nitrite concentrations were not different between meals ( meal p = 0.812 ; time p = 0.45 ; meal time interaction p = 0.50 ) .
RESULTS	Plasma ANP , AVP and ET-1 were not different between meals .
RESULTS	AI was significantly increased following the high sodium meal ( p = 0.02 ) but there was no effect on BP .
CONCLUSIONS	A meal containing 65 mmol Na increases serum sodium and arterial stiffness but does not alter postprandial nitrate/nitrite concentration in healthy normotensive individuals .
CONCLUSIONS	Further research is needed to explore the mechanism by which salt affects vascular function in the postprandial period .
CONCLUSIONS	This trial was registered with the Australian and New Zealand Clinical Trials Registry Unique Identifier : ACTRN12611000583943http : / / www.anzctr.org.au/trial_view.aspx?ID=343019 .

###25350669
BACKGROUND	Many observational studies linked vitamin D to cardiometabolic risks besides its pivotal role in musculoskeletal diseases , but evidence from trials is lacking and inconsistent .
OBJECTIVE	To determine whether Vitamin D supplementation in urban premenopausal women with vitamin D deficiency can improve cardiometabolic risks and health-related quality of life ( HRQOL ) .
METHODS	A double-blind randomized controlled trial was conducted in Kuala Lumpur , Malaysia .
METHODS	A total of 192 vitamin D deficient ( < 50 nmol/l ) premenopausal women were randomized to receive either vitamin D 50,000 IU or placebo once a week for 2 months and then monthly for 10 months .
METHODS	Primary outcomes were serum 25 ( OH ) D , serum lipid profiles , blood pressure and HOMA-IR measured at baseline , 6 months and 12 months .
METHODS	HRQOL was assessed with SF-36 at baseline and 12 months .
RESULTS	Ninety three and ninety-nine women were randomised into intervention and placebo groups respectively .
RESULTS	After 12 months , there were significant differences in the serum 25 ( OH ) D concentration ( mean difference : 49.54 ; 95 % CI : 43.94 to 55.14 ) nmol/l ) and PTH levels ( mean difference : -1.02 ; 95 % CI : -1.67 to -0.38 pmol/l ) in the intervention group compared to placebo group .
RESULTS	There was significant difference between treatment group in both serum 25 ( OH ) D and PTH .
RESULTS	There was no effect of supplementation on HOMA-IR , serum lipid profiles and blood pressure ( all p > 0.05 ) between two groups .
RESULTS	There was a small but significant improvement in HRQOL in the components of vitality ( mean difference : 5.041 ; 95 % CI : 0.709 to 9.374 ) and mental component score ( mean difference : 2.951 ; 95 % CI : 0.573 to 5.329 ) in the intervention group compared to placebo group .
CONCLUSIONS	Large and less frequent dosage vitamin D supplementation was safe and effective in the achievement of vitamin D sufficiency .
CONCLUSIONS	However , there was no improvement in measured cardiometabolic risk factors in premenopausal women .
CONCLUSIONS	Conversely vitamin D supplementation improves some components of HRQOL .
BACKGROUND	Australian New Zealand Clinical Trial Registry ACTRN12612000452897 .

###24246589
BACKGROUND	A hip fracture causes bleeding , pain and immobility , and initiates inflammatory , hypercoagulable , catabolic and stress states .
BACKGROUND	Accelerated surgery may improve outcomes by reducing the duration of these states and immobility .
BACKGROUND	We undertook a pilot trial to determine the feasibility of a trial comparing accelerated care ( i.e. , rapid medical clearance and surgery ) and standard care among patients with a hip fracture .
METHODS	Patients aged 45 years or older who , during weekday , daytime working hours , received a diagnosis of a hip fracture requiring surgery were randomly assigned to receive accelerated or standard care .
METHODS	Our feasibility outcomes included the proportion of eligible patients randomly assigned , completeness of follow-up and timelines of accelerated surgery .
METHODS	The main clinical outcome , assessed by data collectors and adjudicators who were unaware of study group allocations , was a major perioperative complication ( i.e. , a composite of death , preoperative myocardial infarction , myocardial injury after noncardiac surgery , pulmonary embolism , pneumonia , stroke , and life-threatening or major bleeding ) within 30 days of randomization .
RESULTS	Of patients eligible for inclusion , 80 % consented and were randomly assigned to groups ( 30 to accelerated care and 30 to standard care ) at 2 centres in Canada and 1 centre in India .
RESULTS	All patients completed 30-day follow-up .
RESULTS	The median time from diagnosis to surgery was 6.0 hours in the accelerated care group and 24.2 hours in the standard care group ( p < 0.001 ) .
RESULTS	A major perioperative complication occurred in 9 ( 30 % ) of the patients in the accelerated care group and 14 ( 47 % ) of the patients in the standard care group ( hazard ratio 0.60 , 95 % confidence interval 0.26-1 .39 ) .
CONCLUSIONS	These results show the feasibility of a trial comparing accelerated and standard care among patients with hip fracture and support a definitive trial .
BACKGROUND	ClinicalTrials.gov , no .
BACKGROUND	NCT01344343 .

###24688081
OBJECTIVE	To describe an intervention promoting benefit-finding in Alzheimer caregivers , to discuss key issues in implementation and ways to resolve them , and to examine whether the intervention reduced burden and depression in a small randomized trial .
METHODS	Twenty-five caregivers were randomized into benefit-finding and psychoeducation groups .
METHODS	Both groups had eight weekly sessions .
METHODS	Outcome measures including role overload , Zarit Burden Interview , and Hamilton depression scale were collected at baseline and after treatment .
METHODS	Results were analyzed using analysis of covariance .
METHODS	Additionally , the challenges of implementing such interventions , some of which related to cultural issues , were analyzed qualitatively .
RESULTS	Controlling for pretest , the benefit-finding group had lower depression than the psychoeducation group at post-test , despite the fact that some caregivers found benefit-finding challenging .
RESULTS	The two groups did not differ on overload and burden .
RESULTS	However , within-group analysis suggested that both groups showed significant reductions in overload from pretest to post-test .
RESULTS	In addition , we discussed participants ' difficulties in grasping the technique of thought modification for benefit-finding , recording such exercises at home , and sharing their thoughts and experiences in groups .
RESULTS	We described measures undertaken in the main trial to overcome these issues .
CONCLUSIONS	Cognitive approaches focusing on benefit-finding are feasible among Chinese caregivers , with preliminary evidence suggesting an effect on alleviating depression .

###25082070
BACKGROUND	Implantation failure represents a major cause of stress to both clinician and patient undergoing ICSI cycle .
BACKGROUND	Even minor uterine cavity abnormalities , such as endometrial polyps , small submucous myomas , adhesions , and septa are considered to have a negative impact on the chance to conceive through ICSI .
OBJECTIVE	This study aimed at assessing the role of using the office hysteroscopy as a routine investigation in improving ICSI pregnancy rates .
METHODS	ICSI was performed in two groups of infertile women with no abnormality detected in transvaginal ultrasonographic examination , group I : n = 97 and group II : n = 96 , women in group I were subjected to hysteroscopic examination before ICSI while group II underwent ICSI without hysteroscopy .
METHODS	Then , ICSI was performed for all subjects of the two study groups with no statistically significant difference ( p > 0.05 ) regarding the number of oocytes retrieved and the number of embryo transfer .
METHODS	Then , all subjects were followed up for 3 weeks after embryo transfer for detection of pregnancy by ultrasound .
RESULTS	43.3 % of group I showed abnormal hysteroscopic findings .
RESULTS	Group I showed a significantly higher pregnancy rate ( 70.1 % ) than that of group II ( 45.8 % ) ( p = 0.001 ) .
RESULTS	There is statistically significant association between the use of hysteroscopy prior to ICSI and the rate of pregnancy ( OR 2.77 , 95 % CI [ 1.53-5 .00 ] ) .
RESULTS	In addition , hysteroscopy had detected abnormalities in near half of cases whose ultrasound was normal .
CONCLUSIONS	Routine office hysteroscopy is an essential step for infertility workup before ICSI even in patients with normal TV/US .

###25213350
OBJECTIVE	The symptoms with optic ataxia suggest that simple and visually guided hand movements are controlled by 2 different neural substrates .
OBJECTIVE	To assess the differential frequency-coded posterior parietal cortex ( PPC ) role in planning visuo-motor goal-directed tasks , we studied the action specificity of event-related desynchronization ( ERD ) in this area .
METHODS	We investigated cortical activity by electroencephalography , while 16 healthy subjects performed self-paced reaching or wrist extension ( control ) movements .
METHODS	Time-frequency representations were calculated for each movement during the preparatory period .
RESULTS	ERD dynamics in upper alpha-band indicated that preparing a goal-directed action activates contralateral PPC to the moving hand around 1.2 s before starting the movement , while this activation is later ( around 0.7 s ) in preparing a not-goal-directed action .
RESULTS	The posterior dominant rhythm had peak frequency of lower alpha-band at bilateral parietal .
CONCLUSIONS	Posterior parietal cortex encodes goal-directed movement preparation through upper alpha-band activity , whereas general attention is processed via lower alpha-band oscillations .
CONCLUSIONS	Preparing to reach an object engages posterior parietal cortex earlier than a not-goal directed movement .

###26054181
OBJECTIVE	To evaluate the efficacy of a power toothbrush with distinct multi-directional cleaning action using two different heads ( Colgate ProClinical C200 toothbrush with either a triple clean head or a sensitive head ) as compared to a manual flat-trim toothbrush ( Oral B Indicator toothbrush ) on supragingival plaque and established gingivitis .
METHODS	This examiner-blind , randomized , controlled , three-treatment , parallel-group clinical research study assessed plaque removal via the comparison of pre - to post-brushing after a single use and again after four weeks of use , using the Rustogi Modified Navy Plaque Index .
METHODS	This study also assessed gingivitis at four weeks using the Le-Silness Gingival Index .
METHODS	Qualifying adult male and female subjects from the central New Jersey , USA area reported to the study site after refraining from any oral hygiene procedures for 24 hours , and from eating , drinking , and smoking for four hours .
METHODS	Following an examination for plaque and gingivitis , they were randomized into three balanced groups .
METHODS	Subjects were instructed to brush their teeth for two minutes under supervision with their assigned toothbrush and a commercially available toothpaste ( Colgate Cavity Protection toothpaste ) , after which they were again evaluated for plaque .
METHODS	Subjects were dismissed from the study site with the toothpaste and their assigned toothbrush to use at home twice daily for the next four weeks .
METHODS	They reported to the study site after four weeks of product use , at which time they were evaluated for plaque and gingivitis .
RESULTS	One hundred twenty ( 120 ) enrolled subjects complied with the protocol and completed the clinical study .
RESULTS	The results of the study indicated that all three test products provided statistically significant reductions in pre-brushing to post-brushing plaque scores for whole mouth and interproximal sites after a single use .
RESULTS	For gingival margin plaque sites , only the Colgate ProClinical C200 toothbrush , with either the triple clean head or the sensitive head , provided statistically significant reductions in pre - to post-brushing plaque scores .
RESULTS	After four weeks of product use , all three test products provided statistically significant reductions in baseline to four-week whole mouth and interproximal site plaque scores , but only the Colgate ProClinical C200 toothbrush , with either the triple clean head or the sensitive head , provided a statistically significant reduction in plaque scores at gingival margin sites .
RESULTS	All three test products provided statistically significant reductions in gingival and gingivitis severity index scores after four weeks of product use .
RESULTS	Relative to the manual toothbrush group , after a single tooth brushing the Colgate ProClinical C200 toothbrush , with either the triple clean head or sensitive head , provided statistically significantly greater reductions in whole mouth plaque index scores ( 51.9 % and 59.3 % , respectively ) , in gingival margin plaque index scores ( 700 % and 650 % , respectively ) , and interproximal plaque index scores ( 64.2 % and 60.4 % , respectively ) .
RESULTS	Relative to the manual toothbrush group , after four weeks of use the Colgate ProClinical C200 toothbrush , with either the triple clean head or sensitive head , provided statistically significantly greater reductions in whole mouth plaque index scores ( 78.6 % , and 82.1 % , respectively ) , in gingival margin plaque index scores ( 3700 % and 3400 % , respectively ) , and interproximal plaque index scores ( 50.8 % and 52.5 % , respectively ) .
RESULTS	Relative to the manual toothbrush group , after four weeks of use the Colgate ProClinical C200 toothbrush , with either the triple clean head or sensitive head , provided statistically significantly greater reductions in gingival index scores of 900 % and 833 % , respectively , and in gingivitis severity index scores of 466.7 % and 600 % , respectively .
RESULTS	All statistically significant reductions were at the p 0.05 level .
RESULTS	There were no statistically significant differences between the scores of the Colgate ProClinical C200 toothbrush with triple clean head and the scores of the Colgate ProClinical C200 toothbrush with sensitive head at any comparison time point .
CONCLUSIONS	The Colgate ProClinicaI C200 toothbrush , with either a triple clean head or a sensitive head , provides statistically significant and clinically relevant levels of efficacy in the removal of supragingival dental plaque in the whole mouth , at the gingival margin , and interproximally after a single tooth brushing and after four weeks of use , as well as a statistically significantly greater level of efficacy in the reduction of gingivitis and gingival bleeding when compared to a manual flat-trim toothbrush .

###24518789
OBJECTIVE	We compared the effect of 3 animal protein sources on urinary stone risk .
METHODS	A total of 15 healthy subjects completed a 3-phase randomized , crossover metabolic study .
METHODS	During each 1-week phase subjects consumed a standard metabolic diet containing beef , chicken or fish .
METHODS	Serum chemistry and 24-hour urine samples collected at the end of each phase were compared using mixed model repeated measures analysis .
RESULTS	Serum and urinary uric acid were increased for each phase .
RESULTS	Beef was associated with lower serum uric acid than chicken or fish ( 6.5 vs 7.0 and 7.3 mg/dl , respectively , each p < 0.05 ) .
RESULTS	Fish was associated with higher urinary uric acid than beef or chicken ( 741 vs 638 and 641 mg per day , p = 0.003 and 0.04 , respectively ) .
RESULTS	No significant difference among phases was noted in urinary pH , sulfate , calcium , citrate , oxalate or sodium .
RESULTS	Mean saturation index for calcium oxalate was highest for beef ( 2.48 ) , although the difference attained significance only compared to chicken ( 1.67 , p = 0.02 ) but not to fish ( 1.79 , p = 0.08 ) .
CONCLUSIONS	Consuming animal protein is associated with increased serum and urine uric acid in healthy individuals .
CONCLUSIONS	The higher purine content of fish compared to beef or chicken is reflected in higher 24-hour urinary uric acid .
CONCLUSIONS	However , as reflected in the saturation index , the stone forming propensity is marginally higher for beef compared to fish or chicken .
CONCLUSIONS	Stone formers should be advised to limit the intake of all animal proteins , including fish .

###24421901
BACKGROUND	Pre-exposure prophylaxis ( PrEP ) trials using tenofovir-based regimens have demonstrated that high levels of adherence are required to evaluate efficacy ; the incorporation of objective biomarkers of adherence in trial design has been essential to interpretation , given the inaccuracy of self-report .
BACKGROUND	Antiretroviral measurements in scalp hair have been useful as a marker of long-term exposure in the HIV treatment setting , and hair samples are relatively easy and inexpensive to collect , transport , and store for analysis .
BACKGROUND	To evaluate the relationship between dose and tenofovir concentrations in hair , we examined the dose proportionality of tenofovir in hair in healthy , HIV-uninfected adults .
METHODS	A phase I , crossover pharmacokinetic study was performed in 24 HIV-negative adults receiving directly-observed oral tenofovir tablets administered 2 , 4 , and 7 doses/week for 6 weeks , with a 3-week break between periods .
METHODS	Small samples of hair were collected after each six-week period and analyzed for tenofovir concentrations .
METHODS	Geometric-mean-ratios compared levels between each pair of dosing conditions .
METHODS	Intensive plasma pharmacokinetic studies were performed during the daily-dosing period to calculate areas-under-the-time-concentration curves ( AUCs ) .
RESULTS	Over 90 % of doses were observed per protocol .
RESULTS	Median tenofovir concentrations in hair increased monotonically with dose .
RESULTS	A log-linear relationship was seen between dose and hair levels , with an estimated 76 % ( 95 % CI 60-93 % ) increase in hair level per 2-fold dose increase .
RESULTS	Tenofovir plasma AUCs modestly predicted drug concentrations in hair .
CONCLUSIONS	This study found a strong linear relationship between frequency of dosing and tenofovir levels in scalp hair .
CONCLUSIONS	The analysis of quantitative drug levels in hair has the potential to improve adherence measurement in the PrEP field and may be helpful in determining exposure thresholds for protection and explaining failures in PrEP trials .
CONCLUSIONS	Hair measures for adherence monitoring may also facilitate adherence measurement in real-world settings and merit further investigation in upcoming PrEP implementation studies and programs .
BACKGROUND	ClinicalTrials.gov NCT00903084 .

###26010687
OBJECTIVE	Talactoferrin alfa is a recombinant form of the human glycoprotein , lactoferrin , which has been shown to have a wide range of effects on the immune system .
OBJECTIVE	This phase II/III clinical trial compared talactoferrin with placebo , in addition to standard of care , in patients with severe sepsis .
METHODS	Multicenter , randomized , placebo-controlled , phase II/III clinical study .
METHODS	Seventy-seven centers in 10 countries .
METHODS	Adult ( > 18 yr ) patients admitted to one of the participating centers with severe sepsis who were receiving antimicrobial therapy and able to take liquid medication by mouth or feeding tube .
METHODS	Patients were randomized to receive either talactoferrin ( 1.5 g , 15mL ) or placebo three times a day orally or by another enteral route for 28 days or until ICU discharge .
RESULTS	The study was terminated after 305 patients had been enrolled ( 153 talactoferrin and 152 placebo ) because of futility and safety concerns identified by the Data Safety Monitoring Board .
RESULTS	There were no significant differences between groups in baseline characteristics including age , sex , site of infection , and severity scores .
RESULTS	Twenty-eight-day mortality was higher in talactoferrin-treated patients although this difference was not statistically significant ( 24.8 % vs 17.8 % placebo ; p = 0.117 ) .
RESULTS	The difference was largely the result of differences in patients with shock ( talactoferrin , 33/105 [ 31.4 % ] vs placebo , 21/104 [ 20.2 % ] ; p = 0.064 ) ; no mortality difference was seen in patients without shock ( talactoferrin , 5/48 [ 10.4 % ] vs placebo , 6/48 [ 12.5 % ] ; p = 0.806 ) .
RESULTS	In-hospital ( 43/153 [ 28.1 % ] vs 27/152 [ 17.8 % ] ; p = 0.037 ) and 3-month ( 46/153 [ 30.1 % ] vs 31/152 [ 20.4 % ] ; p = 0.036 ) mortality rates were significantly higher in talactoferrin-treated patients than in patients in the placebo group .
RESULTS	The occurrence of treatment-related adverse or serious adverse events was similar between groups .
CONCLUSIONS	Administration of oral talactoferrin was not associated with reduced 28-day mortality in patients with severe sepsis and may even be harmful .

###26390795
OBJECTIVE	To evaluate the surgical effect of levator muscle shortening and levator aponeurosis tucking in treating minimal and moderate congenital blepharoptosis .
METHODS	Clinical data of 28 patients ( 40 eyes ) diagnosed with mide and moderate congenital blepharoptosis at our institution were retrospectively analyzed .
METHODS	Postoperative efficacy was evaluated and statistically compared between these two techniques .
RESULTS	During 14 months follow-up , 16 eyes with ptosis undergoing levator muscle shortening were treated , 3 with undercorrection of ptosis and 1 with overcorrection of ptosis .
RESULTS	In patients receiving levator aponeurosis tucking , 16 eyes were cured and 4 with undercorrection of ptosis .
CONCLUSIONS	Both levator muscle shortening and levator aponeurosis tucking are safe and efficacious for correcting minimal and moderate congenital blepharoptosis .
CONCLUSIONS	( Eye Science

###24357574
BACKGROUND	Despite its high prevalence , help-seeking for depression is low .
OBJECTIVE	To assess the effectiveness and cost-effectiveness of 1-day cognitive-behavioural therapy ( CBT ) self-confidence workshops in reducing depression .
OBJECTIVE	Anxiety , self-esteem , prognostic indicators as well as access were also assessed .
METHODS	An open randomised controlled trial ( RCT ) waiting list control design with 12-week follow-up was used ( trial registration : ISRCTN26634837 ) .
METHODS	A total of 459 adult participants with depression ( Beck Depression Inventory ( BDI ) scores of 14 ) self-referred and 382 participants ( 83 % ) were followed up .
RESULTS	At follow-up , experimental and control participants differed significantly on the BDI , with an effect size of 0.55 .
RESULTS	Anxiety and self-esteem also differed .
RESULTS	Of those who participated , 25 % were GP non-consulters and 32 % were from Black and minority ethnic groups .
RESULTS	Women benefited more than men on depression scores .
RESULTS	The intervention has a 90 % chance of being considered cost-effective if a depression-free day is valued at 14 .
CONCLUSIONS	Self-confidence workshops appear promising in terms of clinical effectiveness , cost-effectiveness and access by difficult-to-engage groups .

###24709304
OBJECTIVE	Open reduction and internal plate fixation of the fibula is the gold standard treatment for ankle fractures .
OBJECTIVE	The aim of this study was to perform a prospective randomized study to compare bone union , complications and functional results of two types of internal fixation of the fibula ( plating and the Epifisa FH intramedullary nail ) .
METHODS	Inclusion criteria were : closed fractures , isolated displaced fractures of the lateral malleolus , inter - and supra-tubercular bimalleolar fractures , and trimalleolar fractures .
METHODS	This study included 71 patients ( mean age 53 19 ) : plate fixation group ( n = 35 ) and intramedullary nail fixation group ( n = 36 ) .
METHODS	In seven cases , intramedullary nailing was technically impossible and was converted to plate fixation ( the analysis of this sub-group was performed independently ) .
METHODS	Two patients died and two patients were lost to follow-up .
METHODS	The final comparative series included 32 cases of plate fixation and 28 cases of intramedullary nail fixation .
METHODS	Union , postoperative complications and Kitaoka and Olerud-Molander functional scores were analyzed after one year of follow-up .
RESULTS	There was no significant difference in the rate of union ( P = 0.5605 ) between the two types of fixation .
RESULTS	There were significantly fewer complications ( 7 % versus 56 % ) and better functional scores ( 96 versus 82 for the Kitaoka score ; 97 versus 83 for the Olerud-Molander score ) with intramedullary nailing than with plate fixation .
CONCLUSIONS	Intramedullary nailing of the lateral malleolus in non-comminuted ankle fractures without syndesmotic injury is a reproducible technique with very few complications that provides better functional results than plate fixation .
METHODS	II ( randomized prospective study ) .

###24682975
BACKGROUND	Research suggests that quantitative information in direct-to-consumer ( DTC ) prescription drug ads may be helpful for consumers .
OBJECTIVE	The objective was to examine the effect of adding placebo rates and framing to DTC ads .
METHODS	In study 1 , 2,000 Internet panel members with chronic pain participated in a randomized controlled experiment of DTC ads varying in placebo rate and framing .
METHODS	In study 2 , 596 physicians ranked DTC ads varying in placebo rate and framing by how well they conveyed scientific information and their usefulness for patients .
RESULTS	In study 1 , participants who viewed placebo rates were able to recall them and use them to form certain perceptions .
RESULTS	A mixed frame led to lower placebo rate recall and perceived efficacy .
RESULTS	In study 2 , overall , physicians preferred a placebo/single frame ad .
CONCLUSIONS	Adding placebo rates to DTC ads may be useful for consumers .
CONCLUSIONS	The evidence does not support using a mixed frame .

###25122597
OBJECTIVE	To investigate adjuvant effect and safety of intratympanic steroid for the treatment of Bell 's palsy .
METHODS	Prospective , investigator blinded , randomized study .
METHODS	Tertiary referral center .
METHODS	Patients who received treatment for Bell 's palsy from December 2007 to March 2011 were randomly divided into two groups .
METHODS	The control group ( n = 17 ) was treated with systemic steroid plus antiviral agent , and intratympanic steroid injection group ( IT group , n = 14 ) received intratympanic steroid injection combined with medications .
METHODS	Facial functions were evaluated on a regular basis up to 6 months .
METHODS	Intratympanic steroid injection .
METHODS	Facial nerve functions of initial presentation and follow-up were evaluated with House-Brackmann ( H-B ) system .
METHODS	Primary outcome was complete recovery rate of 6 months .
METHODS	Secondary outcomes included improvement of H-B grade within 3 weeks , time of first improvement in facial function , and cumulative recovery rate .
METHODS	In addition , subgroup analysis of H-B grade over than IV was performed .
RESULTS	Complete recovery rate was not different between groups .
RESULTS	Time of first improvement was shorter in IT group ( p = 0.043 ) .
RESULTS	And IT group had a better cumulative recovery rate ( p = 0.041 ) and showed the significant improvement in H-B grade within 3 weeks compared with control group ( p = 0.045 ) .
RESULTS	In severe facial palsy , complete recovery rate of IT group and control group were 80 % and 50 % ( p = 0.16 ) , and IT groups showed the significant facial improvement within 3 weeks ( p = 0.025 ) .
RESULTS	And there were no major adverse effects of intratympanic injection .
CONCLUSIONS	Intratympanic steroid injection might be a safe and useful adjuvant treatment modality for Bell 's palsy .

###25546255
OBJECTIVE	The hypothesis was that a reminder about recommended primary care physician ( PCP ) follow-up , sent via e-mail to patients discharged from the emergency department ( ED ) , would increase the proportion of patients who followed up with their PCPs within the recommended time frame .
OBJECTIVE	Patient receptiveness to e-mail follow-up reminders was also assessed .
METHODS	This was a mixed methods clinical intervention study with subjects randomized either to receive the usual care discharge instructions only or to also receive a reminder e-mail message the day after the ED visit .
METHODS	The reminder e-mail contained the subject 's PCP 's name and address and the recommended PCP follow-up time interval .
METHODS	A blinded review of outpatient PCP medical records was conducted to determine whether and when follow-up occurred .
METHODS	Researchers attempted to contact patients with a telephone survey 2 weeks after their ED visits .
METHODS	The primary outcomes between groups were compared using chi-square tests and relative risks ( RRs ) with 95 % confidence intervals ( CIs ) .
RESULTS	Thirty-three percent of the intervention group and 32 % of the control group followed-up as recommended ( RR = 1.04 , 95 % CI = 0.81 to 1.33 ) ; 52 % of the intervention group and 48 % of the control group followed-up within 10 days of the recommended time ( RR = 1.08 , 95 % CI = 0.91 to 1.29 ) .
RESULTS	The 334 patients ( 57 % ) successfully contacted via telephone demonstrated a high interest in receiving future e-mail reminders ( 75 % ) , with the group that received e-mail reminders more likely to want one in the future than those who did not receive e-mail reminders ( 82.5 % vs. 69.76 % ; p = 0.04 ) .
CONCLUSIONS	E-mail reminders sent after ED visits did not improve patients ' adherence to the recommended timing of primary care follow-up contained in discharge instructions .
CONCLUSIONS	Subjects in both the control and the intervention groups favorably viewed the concept of e-mail reminders , suggesting that the value of e-mail reminders after ED discharge may be in areas such as patient satisfaction that were not specifically targeted for measurement in this study .

###24781035
OBJECTIVE	The aim of this open , observational registry was to evaluate the effects of antithrombotic treatment on the development of postthrombotic syndrome ( PTS ) : the effects of `` standard management '' ( SM ; according to International Union of Angiology guidelines ) were compared to SM in association with sulodexide or aspirin .
METHODS	Postthrombotic syndrome occurrence was observed in 3 nonparallel groups after deep venous thrombosis ( DVT ) ; the registry started after the end of the anticoagulation period .
METHODS	The target was to observe the occurrence of PTS in 5 years .
METHODS	Three possible options were suggested to the patients , and the patients and their caregivers defined the type of management .
METHODS	A group of 167 patients was involved in the SM with reevaluation every 6 months ; the sulodexide group included 124 patients and the aspirin group included 48 patients .
RESULTS	The 3 groups were clinically similar and comparable for age and sex distribution .
RESULTS	Of the 167 patients in the SM group , 154 patients completed 60 months of follow-up .
RESULTS	The percentage of patients with PTS in the SM group ranged from 14.9 % ( 1 year after the end of anticoagulation ) to 19.5 % ( 60 months ) .
RESULTS	In the nonparallel group using sulodexide ( 124 comparable patients at inclusion ; 115 at 60 months ) , the percentage of PTS was variable from 8.8 % ( 1 year after anticoagulants ) to 12.17 % at 60 months .
RESULTS	These percentages are significantly lower than those observed with SM .
RESULTS	In the nonparallel aspirin group ( 48 patients at inclusion and 34 at 54 months ) , there was a PTS incidence of 23.5 % at 54 months ( vs 12.17 % in the sulodexide group and 18.23 % in the SM group ) .
RESULTS	The incidence of PTS was significantly higher in comparison with the other 2 groups .
RESULTS	The incidence of PTS was lower in the sulodexide group in comparison with the 2 other groups .
CONCLUSIONS	Sulodexide administration after DVT appears to be effective in preventing PTS in association with recommended management and a number of recurrent DVTs .
CONCLUSIONS	Modalities of treatment , dosages , and timing of administration should be explored in more comprehensive and complete studies .

###25044072
OBJECTIVE	Home-based interventions for heart failure ( HF ) patients might be particularly effective in middle-income countries , where social , cultural , and economic constraints limit the effectiveness of HF treatment outside the hospital environment .
RESULTS	HELEN-II was a randomized clinical trial conducted in Brazil designed to evaluate the clinical efficacy of a nurse-based strategy , started after discharge following an acute decompensated HF ( ADHF ) admission .
RESULTS	HELEN-II compares the efficacy of home visits and telephone reinforcement ( n = 123 ) with that of the conventional strategy , which is based on medical follow-up ( n = 129 ) .
RESULTS	The primary outcome was a composite endpoint of a first visit to the emergency department ( 24 h ) , a hospital readmission ( > 24 h ) , or all-cause death , assessed during the first 6 months of follow-up .
RESULTS	Most enrolled subjects were middle-aged ( 62 13 years ) males ( 63 % ) in NYHA functional class II-III ( 84 % ) with severe LV dysfunction ( mean LVEF 29.6 9 % ) .
RESULTS	The primary composite endpoint was decreased by 27 % in the interventional group ( relative risk 0.73 ; 95 % confidence interval 0.54-0 .99 ; P = 0.049 ) .
RESULTS	At the end of follow-up , the rate of use of the standard-of-care HF medications was similar in both groups , except for the higher use of furosemide in the interventional group .
RESULTS	Also , HF knowledge and self-care were significantly increased in the interventional group .
CONCLUSIONS	A post-discharge , nurse-led management strategy significantly decreases the morbidity of ADHF patients in the public health system of a developing middle-income country .

###24674297
BACKGROUND	The value of hyperbaric oxygen therapy ( HBOT ) in the treatment of diabetic ulcers is still under debate .
BACKGROUND	Available evidence suggests that HBOT may improve the healing of diabetic ulcers , but it comes from small trials with heterogeneous populations and interventions .
BACKGROUND	The DAMOCLES-trial will assess the ( cost - ) effectiveness of HBOT for ischemic diabetic ulcers in addition to standard of care .
METHODS	In a multicenter randomized clinical trial , including 30 hospitals and all 10 HBOT centers in the Netherlands , we plan to enroll 275 patients with Types 1 or 2 diabetes , a Wagner 2 , 3 or 4 ulcer of the leg present for at least 4 weeks , and concomitant leg ischemia , defined as an ankle systolic blood pressure of < 70mmHg , a toe systolic blood pressure of < 50mmHg or a forefoot transcutaneous oxygen tension ( TcpO2 ) of < 40mmHg .
METHODS	Eligible patients may be candidates for revascularization .
METHODS	Patients will be randomly assigned to standard care with or without 40 HBOT-sessions .
RESULTS	Primary outcome measures are freedom from major amputation after 12 months and achievement of , and time to , complete wound healing .
RESULTS	Secondary endpoints include freedom from minor amputations , ulcer recurrence , TcpO2 , quality of life , and safety .
RESULTS	In addition , we will assess the cost-effectiveness of HBOT for this indication .
CONCLUSIONS	The DAMOCLES trial will be the largest trial ever performed in the realm of HBOT for chronic ulcers , and it is unique for addressing patients with ischemic diabetic foot ulcers who may also receive vascular reconstructions .
CONCLUSIONS	This matches the treatment dilemma in current clinical practice .

###24570980
OBJECTIVE	To evaluate whether 5 5 mm dental implants with a novel nanostructured calciumincorporated titanium surface could be an alternative to implants at least 10 mm long placed in bone augmented with bone substitutes in posterior atrophic jaws .
METHODS	A total of 40 patients with atrophic posterior ( premolar and molar areas ) mandibles having 5 to 7 mm of bone height above the mandibular canal and 40 patients with atrophic maxillae having 4 to 6 mm below the maxillary sinus , were randomised according to a parallel group design to receive one to three 5 mm implants or one to three at least 10 mm-long implants in augmented bone at two centres .
METHODS	All implants had a diameter of 5 mm .
METHODS	Mandibles were vertically augmented with interpositional bovine bone blocks and resorbable barriers .
METHODS	Implants were placed after 4 months .
METHODS	Maxillary sinuses were augmented with particulated porcine bone via a lateral window covered with resorbable barriers and implants were placed simultaneously .
METHODS	All implants were submerged and loaded after 4 months with provisional prostheses .
METHODS	Four months later , definitive screw-retained or provisionally cemented metal-ceramic or zirconia prostheses were delivered .
METHODS	Patients were followed up to 1 year post-loading and the outcome measures were prosthesis and implant failures , any complications and peri-implant marginal bone level changes .
RESULTS	One maxillary grafted patient dropped out before the 1-year evaluation .
RESULTS	In mandibles , 1 grafted patient did not want to go ahead with the treatment because of multiple complications and graft failure , and another grafted patient did not receive his prostheses due the loss of 2 implants .
RESULTS	In maxillae , one 5 5 mm implant failed with its provisional crown 3 months post-loading .
RESULTS	There were no statistically significant differences in prostheses and implant failures .
RESULTS	Significantly more complications occurred at both mandibular and maxillary grafted sites : 17 augmented patients were affected by complications versus 8 patients treated with short implants in the mandible ( P = 0.0079 ; difference in proportion = -0.45 ; 95 % CI -0.67 to -0.15 ) , and 5 sinus-lift patients versus none treated with maxillary short implants ( P = 0.047 ; difference in proportion = -0.25 ; 95 % CI -0.44 to -0.06 ) .
RESULTS	Patients with mandibular short implants lost on average 0.94 mm of peri-implant bone at 1 year and patients with 10 mm or longer mandibular implants lost 1.03 mm .
RESULTS	Patients with maxillary short implants lost on average 0.87 mm of peri-implant bone at 1 year and patients with 10 mm or longer maxillary implants lost 1.15 mm .
RESULTS	There were no statistically significant differences in bone level changes up to 1 year between short and longer implants in maxillae ( mean difference -0.28 mm , 95 % CI -0.56 to 0.01 , P = 0.051 ) and in mandibles ( mean difference -0.09 mm , 95 % CI -0.26 to 0.08 , P = 0.295 ) .
CONCLUSIONS	One year after loading , 5 5 mm implants achieved similar results compared to longer implants placed in augmented bone .
CONCLUSIONS	Short implants might be a preferable choice to bone augmentation especially in posterior mandibles since the treatment is faster , cheaper and associated with less morbidity , however 5 to 10 years of post-loading data are necessary before making reliable recommendations .
BACKGROUND	MegaGen partially supported this trial and donated implants and prosthetic components used in this study , whereas Tecnoss donated the biomaterials .
BACKGROUND	The data belonged to the authors and by no means did the manufacturers interfere with the conduct of the trial or the publication of its results .

###24673608
BACKGROUND	Long-duration beta-lactam antibiotics are used for empirical treatment in female dogs with uncomplicated bacterial cystitis .
BACKGROUND	However , women with bacterial cystitis are treated with short-duration potentiated sulfonamides because longer courses of beta-lactams result in lower cure and higher recurrence rates .
OBJECTIVE	Short-duration potentiated sulfonamide treatment is more efficacious than long-duration beta-lactam treatment in achieving clinical and microbiological cures in female dogs with uncomplicated bacterial cystitis .
METHODS	Thirty-eight client-owned female dogs .
METHODS	Randomized , double-blinded , placebo-controlled clinical trial .
METHODS	Dogs were treated with TMP-SMX ( 15 mg/kg PO q12h for 3 days followed by a placebo capsule PO q12h for 7 days ; Group SDS ; n = 20 ) or cephalexin ( 20 mg/kg PO q12h for 10 days ; Group LDBL ; n = 18 ) .
METHODS	Dogs were monitored for clinical and microbiological cure during treatment and at short - and long-term follow-up .
RESULTS	No statistically significant differences were found between treatment groups in clinical cure rates after 3 days of treatment ( 89 % SDS , 94 % LDBL ; P = 1.00 ) and 4 days ( 85 % SDS , 72 % LDBL ; P = .44 ) or > 30 days ( 50 % SDS , 65 % LDBL ; P = .50 ) after conclusion of treatment or in microbiological cure rates 4 days ( 59 % SDS , 36 % LDBL ; P = .44 ) or > 30 days ( 44 % SDS , 20 % LDBL ; P = .40 ) after conclusion of treatment .
CONCLUSIONS	We did not identify a difference in cure rates between short-duration sulfonamide and long-duration beta-lactam treatments in female dogs with uncomplicated cystitis .
CONCLUSIONS	Long-term cure rates in both treatment groups were low .
CONCLUSIONS	In some female dogs , `` uncomplicated '' bacterial cystitis may be more complicated than previously recognized .

###25133963
OBJECTIVE	We evaluated the COX-2 inhibitors , etoricoxib and celecoxib , in Korean patients with osteoarthritis ( OA ) .
METHODS	This study included patients ( 40 years of age ) with a clinical and radiographic diagnosis of knee OA .
METHODS	Patients were randomized to etoricoxib 30 mg ( qd ) or celecoxib 200 mg ( qd ) in a 12 week randomized , controlled , double-blind study .
METHODS	Prior NSAID users were to demonstrate a worsening of symptoms upon withdrawal of medication .
METHODS	Efficacy endpoints included the time-weighted average change from baseline in the WOMAC VA 3.0 Pain Subscale ( 100 mm Visual Analog Scale [ VAS ] ; primary endpoint ) , the WOMAC VA 3.0 Physical Function Subscale ( 100 mm VAS ) , and Patient Global Assessment of Disease Status ( PGAD ) ( 100 mm VAS ) .
METHODS	The primary hypothesis was that etoricoxib 30 mg is non-inferior to celecoxib 200 mg as assessed by the primary endpoint ( the non-inferiority margin was set at 10 mm VAS ) .
METHODS	Adverse events ( AEs ) , laboratory parameters , and vital signs were monitored .
RESULTS	There were 239 patients ( 89.5 % female ; mean age : 63.3 years ) randomized to etoricoxib 30 mg ( n = 120 ) and celecoxib 200 mg ( n = 119 ) .
RESULTS	The differences ( etoricoxib vs celecoxib ) in least square ( LS ) mean change ( 95 % CI ) for WOMAC Pain , WOMAC Physical Function , and PGAD were -1.63 mm ( -5.37 , 2.10 ) , -1.32 mm ( -4.88 , 2.23 ) , and -1.09 mm ( -5.48 , 3.30 ) , respectively .
RESULTS	Drug-related clinical AEs occurred in 6.7 % ( etoricoxib ) and 2.5 % ( celecoxib ) of patients .
RESULTS	This study was limited because it was not designed or powered to adequately capture and evaluate rare AEs associated with NSAID treatment .
CONCLUSIONS	Etoricoxib 30 mg administered once daily in Korean patients with knee OA demonstrated non-inferior clinical efficacy to celecoxib 200 mg over 12 weeks of treatment as assessed by all primary and secondary outcomes .
CONCLUSIONS	Etoricoxib 30 mg qd and celecoxib 200 mg qd were generally safe and well tolerated .
BACKGROUND	NCT01554163 .

###24582466
BACKGROUND	Although eye exercises appear to help heterophoria , convergence insufficiency , and intermittent strabismus , results can be confounded by placebo , practice , and encouragement effects .
BACKGROUND	This study assessed objective changes in vergence and accommodation responses in naive young adults after a 2-week period of eye exercises under controlled conditions to determine the extent to which treatment effects occur over other factors .
METHODS	Asymptomatic young adults were randomly assigned to one of two no-treatment ( control ) groups or to one of six eye exercise groups : accommodation , vergence , both , convergence in excess of accommodation , accommodation in excess of convergence , and placebo .
METHODS	Subjects were tested and retested under identical conditions , except for the second control group , who were additionally encouraged .
METHODS	Objective accommodation and vergence were assessed to a range of targets moving in depth containing combinations of blur , disparity , and proximity/looming cues .
RESULTS	A total of 156 subjects were included .
RESULTS	Response gain improved more for less naturalistic targets where more improvement was possible .
RESULTS	Convergence exercises improved vergence for near across all targets ( P = 0.035 ) .
RESULTS	Mean accommodation changed similarly but nonsignificantly .
RESULTS	No other treatment group differed significantly from the nonencouraged control group , whereas encouraging effort produced significantly increased vergence ( P = 0.004 ) and accommodation ( P = 0.005 ) gains in the second control group .
CONCLUSIONS	True treatment effects were small , significantly better only after vergence exercises to a nonaccommodative target , and rarely related to the response they were designed to improve .
CONCLUSIONS	Exercising accommodation without convergence made no difference to accommodation to cues containing detail .
CONCLUSIONS	Additional effort improved objective responses the most .

###25625260
BACKGROUND	Both propofol infusions with oxygen delivered through nasal cannula and isoflurane/N2O ( nitrous oxide ) delivered via a laryngeal mask airway ( LMA ) are used to provide anesthesia for children undergoing magnetic resonance imaging scans .
BACKGROUND	We compared the incidence of adverse events and perioperative physiologic responses in children anesthetized with these 2 regimens .
METHODS	One hundred-fifty healthy children , ages 1 to 10 years , were randomized to receive either a propofol infusion ( starting at 300 g kgmin ) with oxygen via nasal cannula ( n = 75 ) or isoflurane with 70 % N2O in oxygen delivered via an LMA ( n = 75 ) , both after a sevoflurane/N2O/oxygen induction .
METHODS	Adverse airway events , as well as hemodynamic , respiratory , and other physiologic responses were recorded during the magnetic resonance imaging scans and in the postanesthesia care unit by a single research nurse who was blind to the treatments .
METHODS	All parents were contacted postoperatively to complete a postanesthetic follow-up .
RESULTS	All 150 children completed their scans .
RESULTS	The frequency of all adverse airway events during emergence and recovery after propofol ( 12 % ) was significantly less than that after isoflurane/N2O/LMA ( 49 % ) ( 95 % confidence interval for the risk difference was 23 % -50 % ) ( P = 0.0001 ) .
RESULTS	Hemodynamic responses and recovery times for the 2 treatments were similar .
RESULTS	Early recovery , defined as the time interval from admission to the postanesthesia care unit until eye opening and wakefulness ( modified Aldrete score > 5 ) , after propofol was more rapid than that after isoflurane/N2O/LMA ( P = 0.0001 and P = 0.0012 , respectively ) .
RESULTS	No scans had to be repeated .
CONCLUSIONS	The frequency of adverse airway events during emergence and recovery after propofol infusion with oxygen by nasal cannula is less than with isoflurane/N2O/LMA in children .

###25008011
BACKGROUND	The Indian plant root Salacia reticulata , which is rich in alpha-glucosidase inhibitors , is used for metabolic disorders in Ayurvedic medicine .
BACKGROUND	Vitamin D is also used in the treatment of some metabolic diseases .
BACKGROUND	Our goal was to determine its potential effect for humans with obesity .
METHODS	In a randomized open-label study , we investigated 40 healthy participants aged 30 - 60 years , physically active , with a body mass index ( BMI ) of 25 - 45 .
METHODS	The participants were randomly allocated into two groups .
METHODS	Body weight , BMI , and body composition were measured .
METHODS	Both groups ( A and B ) received a guideline for lifestyle and fitness training for 4 weeks .
METHODS	Group B additionally took one capsule containing 200 mg of Salacia reticulata and 1.6 g ( i. e. 64 IU ) Vitamin D ( SRD ) 3 times/day with the meals .
RESULTS	Significant weight and body-fat reduction within 4 weeks was observed .
RESULTS	Group A lost 1.8 kg or 2.1 % , group B lost 5.3 kg or 6.1 % ( p = 0.03 ) , therefore BMI reduction was achieved .
RESULTS	While Group A lost 1.4 % of body fat , group B reduced it by 4.5 % ( p = 0.01 ) .
CONCLUSIONS	These promising results suggest that the combination of Salacia reticulata and Vitamin D might be highly valuable and potent to treat overweight and obesity , especially in addition to a modifying lifestyle program .
CONCLUSIONS	Further research is needed in addition to this study to clarify pathways and effect mechanisms .

###24488983
BACKGROUND	Prior claims analyses suggest that the use of intravenous inotropic therapy for patients hospitalized with heart failure varies substantially by hospital .
BACKGROUND	Whether differences in the clinical characteristics of the patients explain observed differences in the use of inotropic therapy is not known .
RESULTS	We sought to characterize institutional variation in inotrope use among patients hospitalized with heart failure before and after accounting for clinical factors of patients .
RESULTS	Hierarchical generalized linear regression models estimated risk-standardized hospital-level rates of inotrope use within 209 hospitals participating in Get With The Guidelines-Heart Failure ( GWTG-HF ) registry between 2005 and 2011 .
RESULTS	The association between risk-standardized rates of inotrope use and clinical outcomes was determined .
RESULTS	Overall , an inotropic agent was administered in 7691 of 126 564 ( 6.1 % ) heart failure hospitalizations : dobutamine 43 % , dopamine 24 % , milrinone 17 % , or a combination 16 % .
RESULTS	Patterns of inotrope use were stable during the 7-year study period .
RESULTS	Use of inotropes varied significantly between hospitals even after accounting for patient and hospital characteristics ( median risk-standardized hospital rate , 5.9 % ; interquartile range , 3.7 % -8.6 % ; range , 1.3 % -32.9 % ) .
RESULTS	After adjusting for case-mix and hospital structural differences , model intraclass correlation indicated that 21 % of the observed variation in inotrope use was potentially attributable to random hospital effects ( ie , institutional preferences ) .
RESULTS	Hospitals with higher risk-standardized inotrope use had modestly longer risk-standardized length of stay ( P = 0.005 ) but had no difference in risk-standardized inpatient mortality ( P = 0.12 ) .
CONCLUSIONS	Use of intravenous inotropic agents during hospitalization for heart failure varies significantly among US hospitals even after accounting for patient and hospital factors .

###25123526
BACKGROUND	The addition of domiciliary non-invasive ventilation ( NIV ) to standard therapy in chronic obstructive pulmonary disease ( COPD ) patients with compensated ventilatory failure ( CVF ) is reported to have beneficial effects .
BACKGROUND	Compliance with NIV is an important factor .
BACKGROUND	Volume assured NIV ( va-NIV ) may improve compliance and ventilation during sleep by automatically titrating ventilatory pressures .
METHODS	A prospective single centre , randomised , parallel group trial comparing va-NIV and pressure preset NIV ( pp-NIV ) in COPD patients with CVF nave to domiciliary NIV was performed ( ISCRTN91892415 ) .
METHODS	The primary outcomes were arterial blood gases , mean overnight oximetry ( mSpO2 ) and compliance after three months .
METHODS	Secondary outcomes included pulmonary function , exercise capacity and health-related quality of life assessment .
RESULTS	Forty patients were randomised in a 1:1 ratio .
RESULTS	The va-NIV median target minute ventilation was 8.4 L/min and pp-NIV median inspiratory pressure was 28 cmH2O .
RESULTS	There were no significant differences between groups in primary or secondary outcomes after three months .
RESULTS	Mean ( SD ) PaO2 8.7 ( 1.7 ) versus 7.9 ( 1.7 ) kPa ( p = 0.19 ) , PaCO2 6.7 ( 0.5 ) versus 7.3 ( 1.1 ) kPa ( p = 0.1 ) , mSpO2 89.7 ( 4.2 ) versus 89.8 ( 3.9 ) % ( p = 0.95 ) , compliance 5.0 ( 3.1 ) versus 4.7 ( 3.2 ) hours ( p = 0.8 ) in va-NIV versus pp-NIV respectively .
RESULTS	Patients allocated va-NIV spent fewer days in hospital initiating therapy 3.3 ( 1.6 ) versus 5.2 ( 2.8 ) ( p = 0.02 ) .
RESULTS	Both groups showed significant improvements in PaCO2 and mSpO2 after three months treatment .
CONCLUSIONS	Domiciliary va-NIV and pp-NIV have similar effects on physiological outcomes in COPD patients with CVF and both are well tolerated .

###26074359
OBJECTIVE	The protective effect of ischemic preconditioning ( IP ) in liver transplantation ( LT ) has been studied with controversial results .
OBJECTIVE	We undertook this study to investigate whether IP of cadaveric donor livers is protective to allografts .
METHODS	IP ( LT + IP , n = 6 ) was induced by 10-min hilar clamping .
METHODS	These were compared to cadaver donors with no IP ( LT , n = 7 ) .
METHODS	Clinical data and blood were obtained in donors and recipients for biochemical and inflammatory mediator ( IM ) measurements ( P-selectin , leukotriene B4 , myeloperoxidase , ICAM-1 , IL-1 , IL-6 , and TNF - ) .
METHODS	Liver tissue samples were obtained from donors and recipients ( 90 min after reperfusion ) .
RESULTS	No significant differences were found in demographic characteristics between donors and recipients .
RESULTS	When comparing both groups ( LT + IP vs. LT only ) , ICU stay was longer in LT + IP group .
RESULTS	For biochemical parameters , a significant difference was found only with a higher total bilirubin at postoperative day 3 in LT + IP group .
RESULTS	There was no statistical difference in IM between LT and LT + IP groups at different stages of the study .
RESULTS	Histological analysis of donor grafts indicated the presence of steatosis ( 50 % ) in one graft from the LT + IP group .
RESULTS	However , in post-reperfusion biopsies neither neutrophil infiltration nor grade of necrosis showed significant difference between groups .
RESULTS	No incidence of primary graft nonfunction ( PGNF ) was observed and graft and patient survival was similar in the two groups at 24 months .
CONCLUSIONS	IP does not seem to protect against I/R injury in cadaveric LT , and no PGNF was seen .

###25816805
OBJECTIVE	In subjects without kidney disease , adiponectin appears to have anti-inflammatory , anti-diabetic , and anti-atherogenic effects .
OBJECTIVE	n-3 polyunsaturated fatty acids ( PUFA ) from seafood have several beneficial effects in patients with endstage renal disease ( ESRD ) and the aim of the present study was to assess the effect of n-3 PUFA supplementation on plasma adiponectin levels in ESRD patients .
METHODS	In a double blinded intervention trial , 162 ESRD patients ( mean age 67 years 13 , 56 women and 106 men ) undergoing chronic hemodialysis were randomized to 1.7 g n-3 PUFA daily or placebo for 3 months .
METHODS	Adiponectin , plasma lipids and lipoproteins were measured at baseline and after the intervention period .
RESULTS	At baseline , adiponectin was positively correlated to HDL-cholesterol ( r = 0.55 , p < 0.001 ) and inversely correlated to plasma triglycerides , body mass index ( BMI ) and high sensitive C-reactive protein ( Hs-CRP ) ( r = -0.32 , p < 0.01 , r = -0.43 , p < 0.01 , and r = -0.21 , p < 0.01 , respectively ) .
RESULTS	Furthermore , adiponectin was inversely correlated to the plasma levels of the two major n-3 PUFA docosahexaenoic acid ( DHA ) and eicosapentaenoic acid ( EPA ) ( r = -0.19 , p < 0.001 , and r = -0.30 , p < 0.001 , respectively ) .
RESULTS	Baseline plasma adiponectin levels were high in both groups but after 3 months of supplementation no significant change was observed in the groups .
RESULTS	Thus , n-3 PUFA supplementation did not change adiponectin levels .
CONCLUSIONS	We found an elevated plasma adiponectin level , which was inversely associated with plasma levels of DHA and EPA at baseline .
CONCLUSIONS	Supplementation with n-3 PUFAs for 3 months did not change adiponectin levels .
CONCLUSIONS	The negative result in this study may be related to a relatively low dose and future studies with higher dose and longer duration are needed to explore this mechanism .

###24937018
BACKGROUND	Smokers trying to quit encounter many challenges including nicotine withdrawal symptoms , cigarette craving , increased stress and negative mood and concern regarding weight gain .
BACKGROUND	These phenomena make it difficult to successfully quit smoking .
BACKGROUND	Studies in non-smoking populations show that yoga reduces stress and negative mood and improves weight control .
BACKGROUND	By increasing mindfulness we anticipate that yoga may also improve smokers ' ability to cope with the negative symptoms associated with quitting .
BACKGROUND	Yoga may also improve cognitive deliberation which is needed to make effective choices and avoid smoking in tempting situations .
METHODS	The BreathEasy study is a rigorous , randomized controlled clinical trial examining the efficacy of Iyengar yoga as a complementary therapy to cognitive-behavioral therapy for smoking cessation .
METHODS	All participants are given an 8-week program of smoking cessation classes , and are randomized to either twice weekly yoga ( Yoga ) or twice-weekly health and wellness classes which serve as a control for contact and participant burden ( CTL ) .
METHODS	Assessments are conducted at baseline , 8 weeks , 3 , 6 , and 12 months of follow-up .
METHODS	The primary outcome is prolonged abstinence using an intention-to-treat approach .
METHODS	Multiple internal and external audits using blind data collection are employed to ensure treatment fidelity and reliability of study results .
METHODS	To understand why yoga may be more effective than CTL , we will examine the mechanisms of action ( i.e. , mediators ) underlying intervention efficacy .
METHODS	We will examine the maintenance of yoga practice and smoking status at each follow-up .
METHODS	Focus groups and interviews will be used to enrich our understanding of the relationship of yoga practice and smoking abstinence .
CONCLUSIONS	This study will provide a stringent test of the relative efficacy of yoga compared to a condition that controls for contact time and attention .
CONCLUSIONS	The use of mixed methodology also provides the opportunity to validate existing knowledge about yoga and helps to explore new themes for future mindfulness and yoga research .

###25636764
OBJECTIVE	The Korean Radiation Oncology Group ( KROG ) 08-06 study protocol allowed radiation therapy ( RT ) technique to include or exclude breast cancer patients from receiving radiation therapy to the internal mammary lymph node ( IMN ) .
OBJECTIVE	The purpose of this study was to assess dosimetric differences between the 2 groups and potential influence on clinical outcome by a dummy run procedure .
METHODS	All participating institutions were asked to produce RT plans without irradiation ( Arm 1 ) and with irradiation to the IMN ( Arm 2 ) for 1 breast-conservation treatment case ( breast-conserving surgery [ BCS ] ) and 1 mastectomy case ( modified radical mastectomy [ MRM ] ) whose computed tomography images were provided .
METHODS	We assessed interinstitutional variations in IMN delineation and evaluated the dose-volume histograms of the IMN and normal organs .
METHODS	A reference IMN was delineated by an expert panel group based on the study guidelines .
METHODS	Also , we analyzed the potential influence of actual dose variation observed in this study on patient survival .
RESULTS	Although physicians intended to exclude the IMN within the RT field , the data showed almost 59.0 % of the prescribed dose was delivered to the IMN in Arm 1 .
RESULTS	However , the mean doses covering the IMN in Arm 1 and Arm 2 were significantly different for both cases ( P < .001 ) .
RESULTS	Due to the probability of overdose in Arm 1 , the estimated gain in 7-year disease-free survival rate would be reduced from 10 % to 7.9 % for BCS cases and 7.1 % for MRM cases .
RESULTS	The radiation doses to the ipsilateral lung , heart , and coronary artery were lower in Arm 1 than in Arm 2 .
CONCLUSIONS	Although this dummy run study indicated that a substantial dose was delivered to the IMN , even in the nonirradiation group , the dose differences between the 2 groups were statistically significant .
CONCLUSIONS	However , this dosimetric profile should be studied further with actual patient samples and be taken into consideration when analyzing clinical outcomes according to IMN irradiation .

###26480553
OBJECTIVE	To explore the clinical efficacy of acupoint catgut embedding therapy on chronic pelvic cavity pain syndrome differentiated as kidney deficiency and stagnation of damp heat , and explore the impacts on plasma P substance ( SP ) , plasma beta-endorphin ( - EP ) .
METHODS	One hundred and eighty cases were randomly divided into a catgut embedding group ( 90 cases ) and a western medication group ( 90 cases ) .
METHODS	In the western medication group , tamsulosin capsules 0.2 mg were prescribed for oral administration , once a day ; indometacin sustained release tablets , 25 mg , three times a day .
METHODS	Totally , the oral administration for 8 weeks was required .
METHODS	In the catgut embedding group , the acupoint catgut embedding therapy was applied to Qugu ( CV 2 ) , Shenshu ( BL 23 ) , Zhibian ( BL 54 ) , Huiyin ( CV 1 ) and Sanyinjiao ( SP 6 ) , once every two weeks ; the treatment of 4 weeks made one session , and two sessions were required .
METHODS	Before and after treatment , TCM symptom score , NIH-CPSI ( the National Institute of Health Chronic Prostatitis Symptom Index ) score , lecithin body numbers in prostatic fluid , score in SAS ( self-rating anxiety scale ) , score in SDS ( self-rating depression scale ) , the levels of SP and - EP , etc. were observed in the two groups , and the clinical efficacy was assessed in the two groups .
RESULTS	( 1 ) Ten cases were dropped in either group .
RESULTS	The total effective rate was 91.25 % ( 73/80 ) in the catgut embedding group , higher than 78.75 % ( 63/80 ) in the western medication group ( P < 0.05 ) .
RESULTS	( 2 ) After treatment , TCM symptom score , total score in NIH-CPSI , pain score and the scores in SAS and SDS were all reduced as compared with those before treatment in the two groups ( all P < 0.05 ) .
RESULTS	After treatment , TCM symptom score , total score and pain score in NIH-CPSI , and the scores in SAS and SDS in the catgut embedding group were both lower than those in the western medication group ( all P < 0.05 ) .
RESULTS	( 3 ) After treatment , the lecithin body numbers were both increased as compared with those before treatment in the two groups ( both P < 0.05 ) , and the result in the catgut embedding group was higher than that in the western medication group ( P < 0.05 ) .
RESULTS	( 4 ) After treatment , the SP level was lower than that before treatment in the two groups ( both P < 0.05 ) ; the level of p-EP was increased as compared with that before treatment ( both P < 0.05 ) .
RESULTS	The SP level in the catgut embedding group was lower than that in the western medication group ( P < 0.05 ) ; the level of - EP was higher than that in the western medication group ( P < 0.05 ) .
CONCLUSIONS	The acupoint catgut embedding therapy apparently relieves the clinical symptoms of chronic pelvic cavity pain syndrome differentiated as kidney deficiency and stagnation of damp heat as well as the condition of anxiety and depression , increases lecithin body numbers in prostatic fluid and - EP level and reduces SP level .

###24441153
OBJECTIVE	To assess the effects of tofacitinib on T lymphocytes in RA patients with a special focus on efficacy and infectious adverse events ( iAEs ) .
METHODS	Forty-four RA patients participated in 12-month phase II/III randomized clinical trials and an open-label extension trial .
METHODS	Peripheral lymphocyte subsets and in vitro CD4 ( + ) T lymphocyte proliferation were measured in 23 patients of 44 at baseline and at the end of the 12-month trial .
RESULTS	Forty-four patients [ 35 females , age 54.3 years , disease duration 84.3 months , simplified disease activity index ( SDAI ) 36.5 , CRP 24.9 mg/l , ESR 53 mm/h , MMP-3 284 pg/ml , RF 172.6 IU/ml , neutrophil count 4842 per l , lymphocyte count 1410 per l ] were treated with tofacitinib .
RESULTS	At the end of the study , the SDAI improved to 6.2 , but the peripheral lymphocyte count and absolute numbers of CD4 ( + ) and CD8 ( + ) subpopulations did not change during this period .
RESULTS	However , CD4 ( + ) T lymphocyte proliferation was suppressed , which correlated with the improvement in SDAI , but not with iAEs ( n = 19 ) during the 12-month treatment .
RESULTS	Receiver operating characteristic analysis identified a CD8 ( + ) T lymphocyte count 211 per l at baseline as a significant predictor of clinically significant iAEs .
CONCLUSIONS	The efficacy of tofacitinib is mediated through the suppression of CD4 ( + ) T lymphocyte proliferation without affecting the absolute number of these cells in the periphery .
CONCLUSIONS	A low CD8 ( + ) T cell count at baseline correlated with the development of iAEs during the treatment of RA patients .

###26356160
OBJECTIVE	To evaluate the efficacy and safety of zonisamid as add-on in treatment of partial epilepsy in children , aged 6 years and older , who received 1 or 2 antiepileptic drugs and its effect on their growth and development .
METHODS	Children were randomized to treatment with zonisamid ( n = 107 ) or placebo ( n = 100 ) .
METHODS	Dose was titrated beginning with 1mg/kg daily with a progressive increase to 8mg/kg .
METHODS	After the double-blind phase was completed , patients of the placebo group received zonisamid with the same titration rate and doses .
METHODS	The duration of the open phase was 45-57 weeks .
METHODS	The efficacy was assessed by the percentage of responders ( reduction in the number of seizures by 50 % ) and patients who had not anymore seizures .
METHODS	The safety was evaluated by recording of side-effects , changes in laboratory parameters , neurological and somatic status and ECG .
METHODS	In the open phase , side-effects were recorded using the Tanner scale , bone age , behavioral scales , school records , verbal associative test .
RESULTS	The percentage of responders was 50 % in the zonisamid group and 31 % in the placebo group , stopping of seizures was 14 and 3 % , respectively .
RESULTS	The efficacy of zonisamid remained over long time ( more than one year ) : responders - 56,3 % , stopping of seizures - 11 % of patients .
RESULTS	The total frequency of side-effects was similar in both groups ( 55,1 and 50 % ) .
RESULTS	The open phase did not reveal new adverse effects .
RESULTS	Puberty and bone age did not change during one year of treatment .
RESULTS	Zonisamid did not exert a negative effect on behavior and learning .
RESULTS	Most of the patients and their parents evaluated the changes in the condition of the child as marked improvement or very marked improvement .
CONCLUSIONS	Zonisamid is an effective and well-tolerated medication as add-on in treatment of partial epilepsy in children aged 6 years and older .

###24316704
OBJECTIVE	Was to evaluate the effect of different regional anesthetics ( articaine with epinephrine versus prilocaine with felypressin ) on stress in the extraction of impacted lower third molars in healthy subjects .
METHODS	[ corrected ] A prospective single-blind , split-mouth cross-over randomized study was designed , with a control group .
METHODS	The experimental group consisted of 24 otherwise healthy male volunteers , with two impacted lower third molars which were surgically extracted after inferior alveolar nerve block ( regional anesthesia ) , with a fortnight 's interval : the right using 4 % articaine with 1:100.000 epinephrine , and the left 3 % prilocaine with 1:1.850.000 felypressin .
METHODS	Patients were randomized for the first surgical procedure .
METHODS	To analyze the variation in four stress markers , homovanillic acid , 3-methoxy-4-hydroxyphenylglycol , prolactin and cortisol , 10-mL blood samples were obtained at t = 0 , 5 , 60 , and 120 minutes .
METHODS	The control group consisted of 12 healthy volunteers , who did not undergo either extractions or anesthetic procedures but from whom blood samples were collected and analyzed in the same way .
RESULTS	Plasma cortisol increased in the experimental group ( multiple range test , P < 0.05 ) , the levels being significantly higher in the group receiving 3 % prilocaine with 1:1.850,000 felypressin ( signed rank test , p < 0.0007 ) .
RESULTS	There was a significant reduction in homovanillic acid over time in both groups ( multiple range test , P < 0.05 ) .
RESULTS	No significant differences were observed in homovanillic acid , 3-methoxy-4-hydroxyphenylglycol or prolactin concentrations between the experimental and control groups .
CONCLUSIONS	The effect of regional anesthesia on stress is lower when 4 % articaine with 1:100,000 epinephrine is used in this surgical procedure .

###25261882
OBJECTIVE	The aim of this study was to investigate the role of pravastatin , as an adjunctive therapy , on inflammatory markers , lipid and glucose metabolism , psychopathology , and cognition in subjects with schizophrenia and schizoaffective disorder .
METHODS	Schizophrenia or schizoaffective subjects ( N = 60 ) were randomized to receive either a 12-week supply of pravastatin 40 mg/day or placebo treatment .
METHODS	Anthropometric measures , lipids and glucose metabolism , inflammatory markers , psychopathology and cognitive performance were assessed at baseline , 6 weeks and 12 weeks .
RESULTS	Pravastatin use was associated with a significant decrease in total cholesterol , low density lipoprotein ( LDL ) cholesterol and LDL particle number levels , but was not associated with any significant changes in cognition or psychopathology in the participants , except a significant decrease in the Positive and Negative Syndrome Scale ( PANSS ) positive symptom score from baseline to week 6 .
RESULTS	However , this decrease failed to remain significant at 12 weeks .
RESULTS	Interestingly , triglycerides , LDL-cholesterol , total cholesterol , LDL particle number , small LDL particle number , large very low density lipoprotein ( VLDL ) particle number and C-reactive protein ( CRP ) followed a similar pattern at 6 and 12 weeks as psychopathology .
CONCLUSIONS	These results suggest that a randomized trial with a larger sample size and a higher dosage of pravastatin would be helpful in further evaluating the anti-inflammatory properties of pravastatin , its association with improvements in cognitive symptoms , and its potential to reduce positive and negative symptoms associated with schizophrenia or schizoaffective disorders .

###24997182
OBJECTIVE	To assess the rate of pegaptanib-associated sustained intraocular pressure ( IOP ) elevation .
METHODS	A posthoc analysis was conducted on all IOP measurements , except the immediate 30-min postinjection , from all subjects randomised to pegaptanib 0.3 mg or sham injections continuously in the first 2years of the Vascular endothelial growth factor Inhibition Study in Ocular Neovascularisation ( V.I.S.I.O.N. ) study .
METHODS	Measurements were taken with Goldmann applanation tonometer or Tonopen , except at baseline and in cases of an IOP reading > 30mmHg when a Goldmann applanation tonometer was mandatory .
RESULTS	Of 221 subjects , IOP measurements 22mmHg were seen in 28/114 and 23/107 subjects of the pegaptanib and sham subgroups , respectively ( p = 0.6338 ) and measurements 24mmHg were observed in eight and eight subjects in the pegaptanib and sham groups , respectively .
RESULTS	More than two measurements 22mmHg occurred in six and 10 subjects ( p = 0.3025 ) , and more than two measurements 24mmHg were observed in one and four subjects in the pegaptanib and sham groups , respectively .
RESULTS	One patient with sustained IOP elevation in the pegaptanib study group , and four in the sham group , had IOP lowering medication added during the course of the study .
RESULTS	No subject required glaucoma surgery .
CONCLUSIONS	In V.I.S.I.O.N. , after 2years , there was no evidence of sustained IOP elevation associated with pegaptanib 0.3 mg use .
BACKGROUND	NCT00321997 .

###25140396
BACKGROUND	Statins are effective cholesterol-lowering agents that reduce cardiovascular disease risk but also have pleiotropic effects that may extend to other lipid classes .
OBJECTIVE	The purpose of this article was to investigate , in a post hoc analysis , the dose-dependent effects of rosuvastatin on plasma sphingolipids and phospholipids in men with the metabolic syndrome .
METHODS	Subjects ( n = 12 ) were studied in a randomized , double-blind , triple-crossover trial of a 5-week treatment period with placebo or rosuvastatin ( 10 or 40 mg/day ) with 2-week washouts between treatments .
METHODS	Plasma sphingolipid profiling was determined by liquid chromatography electrospray ionization-tandem mass spectrometry .
RESULTS	Rosuvastatin at 10 mg/d ( R10 ) and 40 mg/d ( R40 ) significantly ( all P < .001 unless stated otherwise ) lowered plasma cholesterol ( -34 % and -42 % [ % change with R10 and with R40 , respectively ] ) , low-density lipoprotein cholesterol ( -49 % and -57 % ) and triglyceride ( -24 % , P = .03 and -42 % ) concentrations .
RESULTS	Compared with placebo , R10 and R40 significantly decreased the plasma levels of total sphingolipids including those of ceramide ( -33 % and -37 % ) , sphingomyelin ( -27 % and -31 % ) , monohexosylceramide ( -40 % and -47 % ) , dihexosylceramide ( -31 % and -34 % ) , and trihexosylceramide ( -29 % and -31 % ) , and GM3 gangliosides ( -29 % and -26 % ) , lysophosphatidylcholine ( -32 % and -37 % ) , alkylphosphatidylcholine ( -19 % and -19 % ) , phosphatidylcholine ( -17 % and -19 % ) , alkenylphosphatidylcholine ( plasmalogen ) ( -20 % and -22 % ) , alkylphosphatidylethanolamine ( -20 % , P = .008 and -24 % , P = .02 ) , alkenylphosphatidylethanolamine ( plasmalogen ) ( -24 % , P = .003 and -23 % , P = .007 ) , phosphatidylglycerol ( -24 % , P = .07 , -31 % , P = .046 ) , and phosphatidylinositol ( -34 % and -40 % ) .
RESULTS	No significant changes were found with phosphatidylethanolamine and phosphatidylserine .
RESULTS	Significant dose effects were found with the majority of the plasma sphingolipids , whereas only phosphatidylcholine , lysophosphatidylcholine , alkylphosphatidylcholine , alkenylphosphatidylcholine ( plasmalogen ) , and phosphatidylinositol had significant dose effects .
RESULTS	Similar changes were found with plasma sphingolipids when results were normalized to the total phosphatidylcholine concentration .
CONCLUSIONS	Rosuvastatin dose-dependently lowers plasma sphingolipids and phospholipids , independent of low-density lipoprotein lowering , in men with the metabolic syndrome .

###25241196
BACKGROUND	Chronic obstructive pulmonary disease ( COPD ) is frequently misdiagnosed or undiagnosed , which can delay disease management interventions .
OBJECTIVE	The Screening , Evaluating and Assessing Rate CHanges of diagnosing respiratory conditions in primary care 1 ( SEARCH1 ) study assessed whether screening using the COPD Population Screener ( COPD-PS ) questionnaire to detect COPD risk factors and symptoms , with or without a handheld spirometer ( copd-6 ) to detect airflow limitation , can increase yields of COPD diagnosis and respiratory-related clinician actions in primary care .
METHODS	A prospective , multi-center , pragmatic , comparative-effectiveness , cluster-randomized study conducted from September 2010 to October 2011 ( data analyzed from December 2011 to January 2013 ) .
METHODS	Men and women aged 40 years visiting their participating primary care practice for any reason .
METHODS	Practices were randomized to three study arms : COPD-PS + copd-6 , COPD-PS alone , and usual care ( no interventions ) .
METHODS	No practices received any specific education about COPD or its diagnosis .
METHODS	The primary endpoint was yield of new clinical COPD diagnosis ; the secondary endpoint was yield of respiratory-related clinician actions .
RESULTS	Of 9,704 patients enrolled , 8,770 had no prior COPD diagnosis and were included in endpoint analyses .
RESULTS	Both interventions significantly increased COPD diagnostic yield over 8 weeks .
RESULTS	Compared with a mean yield of 0.49 % ( 0.13 % ) ( controls ) , yields were 1.07 % ( 0.20 % ) ( OR = 2.20 , 95 % CI = 1.26 , 3.84 , p = 0.006 ) and 1.16 % ( 0.22 % ) ( OR = 2.38 , 95 % CI = 1.38 , 4.13 , p = 0.002 ) for COPD-PS and COPD-PS + copd-6 study arms , respectively .
RESULTS	Respiratory-related clinician actions were not significantly different across study arms .
CONCLUSIONS	Office-based assessment can significantly increase COPD diagnosis by primary care physicians .
CONCLUSIONS	Future trials must evaluate whether screening can improve outcomes for patients with COPD .

###24906863
OBJECTIVE	To estimate minimally important differences ( MIDs ) for the Visual Activities Questionnaire ( VAQ ) and the National Eye Institute-Visual Function Questionnaire ( NEI-VFQ ) .
METHODS	A total of 607 subjects with newly-diagnosed open-angle glaucoma ( OAG ) was enrolled in the Collaborative Initial Glaucoma Treatment Study ( CIGTS ) and randomized to initial treatment with medications or surgery .
METHODS	Subjects underwent an ophthalmic examination and telephone-administered quality of life ( QOL ) interview before randomization and every six months thereafter .
METHODS	The VAQ and NEI-VFQ were used to assess participants ' perceptions of their visual function .
METHODS	Clinical measures included the mean deviation ( MD ) from Humphrey 24-2 full threshold visual field ( VF ) testing , and best-corrected visual acuity ( VA ) measured using the Early Treatment Diabetic Retinopathy Study ( ETDRS ) protocol .
METHODS	Anchor-based ( using MD and VA ) and distribution-based methods were used to estimate MIDs .
RESULTS	Anchor-based cross-sectional analyses at 66 months follow-up found a 10-letter increment in better eye VA corresponded to MIDs of 5.2 units for VAQ and 3.8 units for NEI-VFQ total scores .
RESULTS	A 3-dB increment in the better eye MD yielded MIDs of 2.6 and 2.3 units for the same two questionnaires .
RESULTS	In longitudinal analyses , MIDs for the VAQ were 3.2 units for a 10-letter change of VA and 3.4 units for a 3-dB change in the MD. .
RESULTS	Distribution-based MIDs were larger .
CONCLUSIONS	A range of MIDs for the VAQ ( 2.6-6 .5 units ) and NEI-VFQ ( 2.3-3 .8 units ) was found .
CONCLUSIONS	Although similar in magnitude , MIDs were sensitive to the MID estimation method , the anchor chosen , and differences between questionnaires .
CONCLUSIONS	( ClinicalTrials.gov number , NCT00000149 . )

###25109276
BACKGROUND	Cardiac resynchronization therapy ( CRT ) with multipoint left ventricular ( LV ) pacing in a single coronary sinus branch improves acute LV function .
BACKGROUND	We hypothesized that multipoint pacing ( MPP ) can improve midterm echocardiographic and clinical response compared with conventional CRT .
RESULTS	Consecutive patients receiving a CRT implant ( Unify Quadra MP or Quadra Assura MP CRT-D and Quartet LV lead , St. Jude Medical , Sylmar , CA , USA ) were randomized to receive biventricular ( BiV ) pacing with either conventional LV pacing ( CONV group ) or MPP ( MPP group ) .
RESULTS	For each patient , an optimal pacing configuration for the assigned pacing mode was programmed based on intraoperative pressure-volume ( PV ) loop measurements .
RESULTS	A clinical evaluation and transthoracic echocardiogram were performed before implant ( BASELINE ) and at 3 months postimplant and analyzed by a blinded observer .
RESULTS	A reduction in end-systolic volume ( ESV ) of 15 % relative to BASELINE was prospectively defined as response to CRT .
RESULTS	Forty-four patients ( NYHA Class III , EF 29 6 % , QRS duration 152 17 milliseconds ) were enrolled and randomized .
RESULTS	One patient in the MPP group was lost to follow-up and excluded from further analysis .
RESULTS	After 3 months , 11 of 22 ( 50 % ) CONV patients and 16 of 21 ( 76 % ) MPP patients were classified as responders .
RESULTS	ESV reduction , EF increase , and NYHA class reduction relative to BASELINE were significantly greater in the MPP group than in the CONV group ( ESV : -21.0 13.9 vs. -12.6 11.1 % , P = 0.03 ; EF : +9.8 5.1 vs. +2.0 7.8 percentage points , P < 0.001 ; NYHA : -1.05 0.22 vs. -0.72 0.46 functional classes , P = 0.006 ) .
CONCLUSIONS	PV loop optimized BiV pacing with MPP resulted in an improved rate of response to CRT .

###24786605
BACKGROUND	Diabetes is a risk factor for pancreatic cancer but its association with survival from pancreatic cancer is poorly understood .
BACKGROUND	Our objective was to investigate the association of diabetes with survival among pancreatic cancer patients in a prospective cohort-based study where diabetes history was ascertained before pancreatic cancer diagnosis .
METHODS	We evaluated survival by baseline ( 1993-2001 ) self-reported diabetes history ( n = 62 ) among 504 participants that developed exocrine pancreatic cancer within the Prostate , Lung , Colorectal , and Ovarian ( PLCO ) Cancer Screening Trial .
METHODS	Hazard ratios ( HRs ) and 95 % confidence intervals ( CIs ) for mortality were estimated using Cox proportional hazards model , adjusted for age , sex , body mass index , race , smoking , and tumour stage ( local , locally advanced , and metastatic ) .
RESULTS	The multivariable-adjusted HR for mortality comparing participants with diabetes to those without was 1.52 ( 95 % CI = 1.14-2 .04 , P-value < 0.01 ) .
RESULTS	After excluding those diagnosed with pancreatic cancer within 3 years of study enrolment , HR for mortality among those with diabetes was 1.45 ( 95 % CI = 1.06-2 .00 , P-value = 0.02 ) .
CONCLUSIONS	Using prospectively collected data , our findings indicate that diabetes is associated with worse survival among patients with pancreatic cancer .

###24645901
OBJECTIVE	Korean American ( KA ) parents need a culturally tailored parent training that helps them bridge the Korean and American cultures and divergent parenting practices .
METHODS	The Korean Parent Training Program ( KPTP ) was pilot tested with 48 KA mothers of children between 3 and 8 years old using a partial group-randomized controlled experimental study design .
METHODS	Researchers gathered self-report survey and observation data .
RESULTS	Analyses , which used generalized estimating equations , indicated the intervention group mothers increased use of effective parenting practices and their children decreased behavioral problems and reported less acculturation conflict with their mothers .
CONCLUSIONS	The KPTP is a promising way to promote effective parenting and increase positive child mental health in KA families .

###25305637
OBJECTIVE	To assess body composition modifications in post-pubertal schoolchildren after practice of a physical activity program during one school year .
METHODS	The sample consisted of 386 students aged between 15 and 17 years and divided into two groups : the study group ( SG ) comprised 195 students and the control group ( CG ) , 191 .
METHODS	The SG was submitted to a physical activity program and the CG attended conventional physical education classes .
METHODS	Body composition was assessed using body mass index ( BMI ) , percentage of body fat ( % BF ) , fat mass ( FM ) , and lean mass ( LM ) .
RESULTS	A positive effect of the physical activity program on body composition in the SG ( p < 0.001 ) was observed , as well as on the interaction time x group in all the variables analyzed in both genders .
RESULTS	A reduction in % BF ( mean of differences = -5.58 % ) and waist circumference ( -2.33 cm ) , as well as an increase in LM ( +2.05 kg ) were observed in the SG for both genders , whereas the opposite was observed in the CG .
CONCLUSIONS	The practice of programmed physical activity promotes significant reduction of body fat in post-pubertal schoolchildren .

###24290111
OBJECTIVE	To determine whether a single monthly supplement is as effective as a daily maternal supplement in increasing breast milk vitamin D to achieve vitamin D sufficiency in their infants .
METHODS	Forty mothers with exclusively breast-fed infants were randomized to receive oral cholecalciferol ( vitamin D3 ) 5000 IU/d for 28 days or 150,000 IU once .
METHODS	Maternal serum , breast milk , and urine were collected on days 0 , 1 , 3 , 7 , 14 , and 28 ; infant serum was obtained on days 0 and 28 .
METHODS	Enrollment occurred between January 7 , 2011 , and July 29 , 2011 .
RESULTS	In mothers given daily cholecalciferol , concentrations of serum and breast milk cholecalciferol attained steady levels of 18 and 8 ng/mL , respectively , from day 3 through 28 .
RESULTS	In mothers given the single dose , serum and breast milk cholecalciferol peaked at 160 and 40 ng/mL , respectively , at day 1 before rapidly declining .
RESULTS	Maternal milk and serum cholecalciferol concentrations were related ( r = 0.87 ) .
RESULTS	Infant mean serum 25-hydroxyvitamin D concentration increased from 1713 to 396 ng/mL in the single-dose group and from 1612 to 3912 ng/mL in the daily-dose group ( P = .88 ) .
RESULTS	All infants achieved serum 25-hydroxyvitamin D concentrations of more than 20 ng/mL .
CONCLUSIONS	Either single-dose or daily-dose cholecalciferol supplementation of mothers provided breast milk concentrations that result in vitamin D sufficiency in breast-fed infants .
BACKGROUND	clinicaltrials.gov NCT01240265 .

###24680087
BACKGROUND	Spontaneous intracerebral hemorrhage ( ICH ) can be devastating , particularly if hematoma expansion ( HE ) occurs .
BACKGROUND	Tranexamic acid ( TA ) , an antifibrinolytic drug , significantly reduced mortality in bleeding patients after trauma in the large CRASH-2 trial .
BACKGROUND	The CRASH-2 ICH substudy found that TA nonsignificantly reduced mortality and dependency in traumatic ICH .
BACKGROUND	The aim of this study was to assess the feasibility of performing a randomized controlled trial of tranexamic acid in spontaneous ICH , ahead of a definitive study .
METHODS	We performed a single-center , prospective , randomized ( 2:1 ) , double-blind , placebo-controlled blinded endpoint trial of TA ( intravenous 1 g bolus , 1 g infusion/8 h ) in acute ( < 24 hours ) spontaneous ICH .
METHODS	The primary objective was to test the feasibility of recruiting to the trial .
METHODS	Other objectives included tolerability ( adverse events ) and the effect of TA on HE and death and dependency .
RESULTS	The trial was feasible , with 24 patients enrolled ( TA , n = 16 ; placebo , n = 8 ) between March 2011 and March 2012 , and acceptable-only 3 patients declined to participate .
RESULTS	All patients received the correct randomized treatment ; 1 patient in the TA group did not complete the infusion because of neurologic deterioration .
RESULTS	There were no significant differences in secondary outcomes including adverse events , HE , death , and dependency .
RESULTS	One patient in the TA group had a deep vein thrombosis .
CONCLUSIONS	This , the first randomized controlled trial of TA in ICH , found that the protocol could be delivered on schedule ( 2 patients/mo ) and was feasible .
CONCLUSIONS	Larger studies are needed to assess safety and efficacy of TA in ICH .

###24266552
OBJECTIVE	Pulmonary vein isolation ( PVI ) is an established method for treatment of drug refractory atrial fibrillation .
OBJECTIVE	The aim of this study was to evaluate whether a more active regular supply of analgesic and sedative drugs reduces pain and discomfort .
OBJECTIVE	We also wanted to evaluate gender differences in pain perception and to compare standard radiofrequency ( RF ) with cryo balloon ablation ( Cryo ) from this perspective .
METHODS	A total of 80 patients , 40 men , median age 58 ( range 23-76 ) years , who underwent PVI under conscious sedation were studied .
METHODS	They were randomized to either standard treatment with morphine and diazepam ( control group , C ) or to a more active analgesic strategy ( A ) with pre-medication with oral midazolam mixture and intravenous alfentanil and midazolam regularly administrated during the procedure .
METHODS	Forty patients were treated with RF and 40 with Cryo .
RESULTS	The majority of the patients experienced pain during the procedure .
RESULTS	The maximal pain assessed with numerical rating scale ( NRS ) , was lower in the active group compared with that in controls ( p = 0.02 ) .
RESULTS	Women experienced more pain than men ( p = 0.01 ) .
RESULTS	RF was more painful than Cryo ( p < 0.001 ) .
CONCLUSIONS	An active regular supply of analgesic and sedative drugs reduce pain and discomfort during PVI .
CONCLUSIONS	Women experience more pain than men during this procedure and PVI performed with Cryo is less painful than with RF .

###25468944
OBJECTIVE	We investigated the role of metformin on glucose kinetics during moderate exercise .
METHODS	Before , during , and after a 45-min bout of exercise at 60 % VO2max , glucose kinetics were determined by isotope tracer technique in patients with type 2 diabetes mellitus with metformin treatment ( DM2 + Met ) or without metformin treatment ( DM2 ) and in healthy control subjects ( CON ) matched for BMI and age .
METHODS	Glucoregulatory hormones and metabolites were measured throughout the study .
RESULTS	Plasma glucose concentration was unchanged during exercise in CON but decreased in DM2 .
RESULTS	No significant change was found in DM2 + Met .
RESULTS	Hormones and metabolites showed no differences among the groups except for elevated exercise-induced concentrations of lactate in DM2 ( area under the curve [ AUC ] 31 1 % vs. CON ) and glucagon in DM2 ( AUC 5 1 % vs. DM2 + Met ) .
RESULTS	Free fatty acid levels were lower in DM2 + Met than in DM2 ( AUC -14 1 % ) .
RESULTS	Absolute values of the baseline glucose rate of appearance ( Ra ) were elevated in DM2 and DM2 + Met , but the increase in glucose Ra relative to baseline was blunted in DM2 ( 19 1 % ) and DM2 + Met ( 18 4 % ) compared with CON ( 46 4 % ) .
RESULTS	Glucose rate of disappearance relative to baseline increased more in CON ( 31 3 % ) than in DM2 ( 6 1 % ) and DM2 + Met ( 21 2 % ) , showing a small increase caused by metformin .
RESULTS	Glucose metabolic clearance rate relative to baseline was similar during exercise in DM2 ( 33 1 % ) and CON ( 35 3 % ) but was improved in DM2 + Met ( 37 3 % ) compared with DM2 .
CONCLUSIONS	Metformin has a positive effect on glucose homeostasis during exercise .

###25444354
OBJECTIVE	To assess the effectiveness of an intensive smoking cessation intervention based on the transtheoretical model of change ( TTM ) in diabetic smokers attending primary care .
METHODS	A cluster randomized controlled clinical trial was designed in which the unit of randomization ( intervention vs. usual care ) was the primary care team .
METHODS	An intensive , individualized intervention using motivational interview and therapies and medications adapted to the patient 's stage of change was delivered .
METHODS	The duration of the study was 1 year .
RESULTS	A total of 722 people with diabetes who were smokers ( 345 in the intervention group and 377 in the control group ) completed the study .
RESULTS	After 1 year , continued abstinence was recorded in 90 ( 26.1 % ) patients in the intervention group and in 67 ( 17.8 % ) controls ( p = 0.007 ) .
RESULTS	In patients with smoking abstinence , there was a higher percentage in the precontemplation and contemplation stages at baseline in the intervention group than in controls ( 21.2 % vs. 13.7 % , p = 0.024 ) .
RESULTS	When the precontemplation stage was taken as reference ( OR = 1.0 ) , preparation/action stage at baseline showed a protective effect , decreasing 3.41 times odds of continuing smoking ( OR = 0.293 95 % CI 0.179-0 .479 , p < 0.001 ) .
RESULTS	Contemplation stage at baseline also showed a protective effect , decreasing the odds of continuing smoking ( OR = 0.518 , 95 % CI 0.318-0 .845 , p = 0.008 ) .
CONCLUSIONS	An intensive intervention adapted to the individual stage of change delivered in primary care was feasible and effective , with a smoking cessation rate of 26.1 % after 1 year .

###25951630
OBJECTIVE	To observe the clinical effect of Yangyin Yiqi Huoxue Recipe ( YYHR , the basic recipe of Yangyin Tongnao Granule ) in treatment of ischemic stroke patients of deficiency of qi and yin syndrome ( DQYS ) and static blood obstructing collaterals syndrome ( SBOCS ) .
METHODS	Totally 312 patients were assigned to the control group ( 86 cases ) and the treatment group ( 226 cases ) using strati - fied randomized allocation method .
METHODS	Patients in the treatment group were treated with modified YYHR , while those in the control group took Xueshuan Xinmaining .
METHODS	The treatment course was 4 weeks for all .
METHODS	Constituent ratios of the acute stage and the recovery stage of DQYS and SBOCS and their complicated syndromes were observed in the two groups .
METHODS	Changes of the clinical curative effect , clinical symptoms integral , whole blood viscosity ratio , plasma viscosity ratio , hematocrit , erythrocyte sedimentation rate ( ESR ) , total cho - lesterol ( TC ) , triglyceride ( TG ) , high density lipoprotein cholesterol ( HDL-C ) , and low density lipoprotein cholesterol ( LDL-C ) were detected in the two groups before and after treatment .
RESULTS	There was statistical difference in constituent ratios of the acute stage and the recovery stage of DQYS SBOCS and its complicated syndromes between the two groups ( P < 0.01 ) .
RESULTS	DQYS and SBOCS was basic syndrome types of the two groups .
RESULTS	The cured and markedly effective rate was 71.24 % ( 161/226 ) in the treatment group and 43.02 % ( 37/86 ) in the control group .
RESULTS	The total effective rate was 91.15 % ( 206/226 ) in the treatment group , higher than that of the control group ( 76.74 % , 66/86 ) with statistical difference ( P < 0.01 ) .
RESULTS	There was statistical difference in the clinical symptoms integral , whole blood viscosity ratio , plasma viscosity ratio , hematocrit , ESR , TC , TG,HDL-C , and LDL-C ( P < 0.05 , P < 0.01 ) .
CONCLUSIONS	Symptoms of ischemic stroke patients could be improved by modified YYHR .
CONCLUSIONS	Indices such as the whole blood viscosity , plasma viscosity ratio , hematocrit , ESR , abnormal metabolism of blood lipids were also significantly improved .
CONCLUSIONS	Pathological changes of blood stasis induced by qi-yin deficiency exist in ischemic stroke patients , and DQYS and SBOCS were basic syndrome types .

###25075930
OBJECTIVE	Motivational and cognitive deficits are core features of schizophrenia , both closely linked with functional outcomes .
OBJECTIVE	Although poor effort and decreased motivation are known to affect performance on cognitive tests , the extent of this relationship is unclear in patients with schizophrenia .
OBJECTIVE	To evaluate the association between intrinsic motivation and cognitive test performance in patients with schizophrenia .
METHODS	Cross-sectional and 6-month prospective follow-up study performed at 57 sites in the United States , including academic and community medical treatment centers , participating in the Clinical Antipsychotic Trials of Intervention Effectiveness study .
METHODS	The primary sample included 431 stable patients with a DSM-IV diagnosis of schizophrenia currently receiving a stable medication regimen .
METHODS	Cognitive performance and intrinsic motivation were evaluated using a comprehensive neuropsychological test battery and a derived measure from the Heinrichs-Carpenter Quality of Life Scale , respectively .
METHODS	Symptom severity and functional status were also assessed .
METHODS	The primary outcome variable was global neurocognition .
METHODS	Individual domains of cognition were also evaluated for their association with motivation .
RESULTS	Level of intrinsic motivation was significantly and positively correlated with global cognitive test performance , a relationship that held for each domain of cognition evaluated ( correlation range , 0.20-0 .34 ; P < .001 ) .
RESULTS	This association was found to be reliable after statistically accounting for positive , negative , depressive , and overall symptom severity ( P < .05 ) and after accounting for community functioning ( P < .001 ) .
RESULTS	The relationship between motivation and cognitive performance also remained significant after controlling for antipsychotic dose ( P < .05 ) .
RESULTS	Prospective increase in motivation during the 6-month follow-up was also found to be significantly related to improvement in global cognitive performance ( P < .05 ) .
CONCLUSIONS	The present findings provide strong support for a robust and reliable relationship between motivation and cognitive performance and suggest that test performance is not purely a measure of ability .
CONCLUSIONS	Future studies assessing cognition in patients with schizophrenia should consider potential moderating variables such as effort and motivation .
CONCLUSIONS	Implications for the assessment and interpretation of cognitive impairment based on neuropsychological test measures in schizophrenia are discussed , especially in the case of clinical trials for cognition-enhancing treatments .
BACKGROUND	clinicaltrials.gov Identifier : NCT00014001 .

###24916903
OBJECTIVE	We explored the hypothesis that injured neurons release lipocalin-2 as a help me signal .
METHODS	In vivo lipocalin-2 responses were assessed in rat focal cerebral ischemia and human stroke brain samples using a combination of ELISA and immunostaining .
METHODS	In vitro , microglia and astrocytes were exposed to lipocalin-2 , and various markers and assays of glial activation were quantified .
METHODS	Functional relevance of neuron-to-glia lipocalin-2 signaling was examined by transferring conditioned media from lipocalin-2-activated microglia and astrocytes onto neurons to see whether activated glia could protect neurons against oxygen-glucose deprivation and promote neuroplasticity .
RESULTS	In human stroke samples and rat cerebral ischemia , neuronal expression of lipocalin-2 was significantly increased .
RESULTS	In primary cell cultures , exposing microglia and astrocytes to lipocalin-2 resulted in glial activation .
RESULTS	In microglia , lipocalin-2 converted resting ramified shapes into a long-rod morphology with reduced branching , increased interleukin-10 release , and enhanced phagocytosis .
RESULTS	In astrocytes , lipocalin-2 upregulated glial fibrillary acid protein , brain-derived neurotropic factor , and thrombospondin-1 .
RESULTS	Conditioned media from lipocalin-2-treated astrocytes upregulated synaptotagmin , and conditioned media from lipocalin-2-treated microglia upregulated synaptophysin and post-synaptic density 95 ( PSD95 ) and protected neurons against oxygen-glucose deprivation .
CONCLUSIONS	These findings provide proof of concept that lipocalin-2 is released by injured neurons as a help me distress signal that activates microglia and astrocytes into potentially prorecovery phenotypes .

###25229168
OBJECTIVE	We compared the antihypertensive effect of valsartan ( VAL ) and amlodipine ( AML ) treatments in elderly hypertensive patients by examining the long-term changes in cognitive function and auditory P300 event-related potentials .
METHODS	We enrolled 20 outpatients , including 12 men and 8 women in the age group of 56 to 81 years who had mild to moderate essential hypertension .
METHODS	The subjects were randomly allocated to receive either 80 mg VAL once a day ( 10 patients ) or 5 mg AML once a day ( 10 patients ) .
METHODS	Neuropsychological assessment and auditory P300 event-related potentials were obtained before initiation of VAL or AML treatment and after 6 months of the treatment with VAL or AML .
METHODS	Neuropsychological assessment was evaluated by conducting the Mini-Mental State Examination , the verbal fluency , word-list memory , word-list recall test , word-list recognition , and Trails B tests .
RESULTS	Both the groups showed significantly reduced-blood pressure after 6 months of treatment , and the intergroup difference was not significant .
RESULTS	The mean baseline Mini-Mental State Examination scores of the VAL and AML groups were not significantly different .
RESULTS	Amlodipine treatment did not significantly affect any test score , but VAL treatment significantly increased the word-list memory and word-list recall test scores .
RESULTS	Valsartan , and not AML , significantly reduced the mean P300 latency after 6 months .
CONCLUSIONS	These results suggest that VAL exerts a positive effect on cognitive functions , independent of its antihypertensive effect .

###24457895
OBJECTIVE	Spasmodic dysphonia ( SD ) can be difficult to diagnose , and patients often see multiple physicians for many years before diagnosis .
OBJECTIVE	Improving the speed of diagnosis for individuals with SD may decrease the time to treatment and improve patient quality of life more quickly .
OBJECTIVE	To assess whether the diagnosis of SD can be accurately predicted through auditory cues alone without the assistance of visual cues offered by laryngoscopic examination .
METHODS	Single-masked , case-control study at a specialized referral center that included patients who underwent laryngoscopic examination as part of a multidisciplinary workup for dysphonia .
METHODS	Twenty-two patients were selected in total : 10 with SD , 5 with vocal tremor , and 7 controls without SD or vocal tremor .
METHODS	The laryngoscopic examination was recorded , deidentified , and edited to make 3 media clips for each patient : video alone , audio alone , and combined video and audio .
METHODS	These clips were randomized and presented to 3 fellowship-trained laryngologist raters ( A.D.R. , A.T.H. , and A.M.K. ) , who established the most probable diagnosis for each clip .
METHODS	Intrarater and interrater reliability were evaluated using repeat clips incorporated in the presentations .
METHODS	We measured diagnostic accuracy for video-only , audio-only , and combined multimedia clips .
METHODS	These measures were established before data collection .
METHODS	Data analysis was accomplished with analysis of variance and Tukey honestly significant differences .
RESULTS	Of patients with SD , diagnostic accuracy was 10 % , 73 % , and 73 % for video-only , audio-only , and combined , respectively ( P < .001 , df = 2 ) .
RESULTS	Of patients with vocal tremor , diagnostic accuracy was 93 % , 73 % , and 100 % for video-only , audio-only , and combined , respectively ( P = .05 , df = 2 ) .
RESULTS	Of the controls , diagnostic accuracy was 81 % , 19 % , and 62 % for video-only , audio-only , and combined , respectively ( P < .001 , df = 2 ) .
CONCLUSIONS	The diagnosis of SD during examination is based primarily on auditory cues .
CONCLUSIONS	Viewing combined audio and video clips afforded no change in diagnostic accuracy compared with audio alone .
CONCLUSIONS	Laryngoscopy serves an important role in the diagnosis of SD by excluding other pathologic causes and identifying vocal tremor .

###24613543
OBJECTIVE	Overexpression of epidermal growth factor receptor ( EGFR ) in many cancers makes it an attractive therapeutic target .
OBJECTIVE	This study evaluated the clinical utility of nimotuzumab , a monoclonal anti-EGFR antibody , used concurrently with radiotherapy ( RT ) and chemoradiotherapy ( CRT ) in squamous cell carcinoma of the head and neck ( SCCHN ) .
METHODS	This open-label study randomized 92 treatment-nave patients ( 1:1 ) with advanced SCCHN into chemoradiation ( CRT nimotuzumab ) or radiation ( RT nimotuzumab ) group by investigator 's discretion ; these were further randomized into CRT + nimotuzumab or CRT and RT + nimotuzumab or RT groups , respectively .
METHODS	Treatment included 6 cycles each of cisplatin ( 50 mg/week ) , nimotuzumab ( 200 mg/week ) , and RT ( total dose , 60-66 Gy ) .
METHODS	Response ( tumor size reduction ) was assessed at Month 6 post-treatment and survival , at Month 60 .
RESULTS	Forty and 36 patients in the chemoradiation and radiation groups , respectively ( intent-to-treat population ) were evaluated .
RESULTS	Overall response at Month 6 post-treatment was 100 % with CRT + nimotuzumab , 70 % with CRT , 76 % with RT + nimotuzumab , and 37 % with RT. .
RESULTS	At Month 60 , overall survival was 57 % with CRT + nimotuzumab , 26 % with CRT ( P = 0.03 ) , 39 % with RT + nimotuzumab , and 26 % with RT ( P > 0.05 ) .
RESULTS	Median overall survival was not reached for CRT + nimotuzumab ; it was 21.94 months for CRT ( P = 0.0078 ) , 14.36 months for RT + nimotuzumab , and 12.78 months for RT ( P = 0.45 ) .
RESULTS	Risk of death was 64 % lower with CRT + nimotuzumab than with CRT ( 95 % CI : 0.37 , 1.56 ) , and 24 % lower with RT + nimotuzumab than with RT ( 95 % CI : 0.16 , 0.79 ) .
RESULTS	Thus nimotuzumab was safe and well tolerated with few mild to moderate self-limiting adverse events .
CONCLUSIONS	Concurrent use of nimotuzumab with CRT/RT is safe and provides long-term survival benefit .

###25495272
OBJECTIVE	Sequential therapy is a two-step therapy achieving a promising eradication rate for Helicobacter pylori infection .
OBJECTIVE	The rationale of sequential method has been proposed that amoxicillin weakens bacterial cell walls in the initial phase of treatment , preventing the development of drug efflux channels for clarithromycin and metronidazole used in the second phase .
OBJECTIVE	The aim of this prospective , randomized , controlled study was to investigate whether the efficacy of reverse sequential therapy was noninferior to sequential therapy in the treatment of H.pylori infection .
METHODS	From January 2009 to December 2010 , consecutive H.pylori-infected patients were randomly assigned to receive either sequential therapy ( a 5-day dual therapy with pantoprazole plus amoxicillin , followed by a 5-day triple therapy with pantoprazole plus clarithromycin and metronidazole ) or reverse sequential therapy ( a 5-day triple therapy with pantoprazole plus clarithromycin and metronidazole , followed by a 5-day dual therapy with pantoprazole plus amoxicillin ) .
METHODS	H.pylori status was examined 6weeks after the end of treatment by rapid urease and histology or urea breath test .
RESULTS	One hundred and twenty-two H.pylori-infected participants were randomized to receive sequential ( n = 60 ) or reverse sequential therapy ( n = 62 ) .
RESULTS	The eradication rates , by intention-to-treat analysis , were similar : 91.9 % ( 95 % confidence interval ( CI ) : 85.1-98 .7 % ) for sequential therapy and 96.7 % ( 95 % CI : 92.2-101 .2 % ) for reverse sequential therapy ( p = .44 ) .
RESULTS	Per-protocol analysis also showed similar results : 91.8 % ( 95 % CI : 84.9-98 .7 % ) for sequential group and 96.7 % ( 95 % CI : 92.2-101 .2 % ) for reverse sequential therapy ( p = .43 ) .
RESULTS	The two treatments exhibited comparable frequencies of adverse events ( 11.3 % vs 6.7 % , respectively ) and drug compliance ( 98.4 % vs 100 % , respectively ) .
RESULTS	The overall resistance rates of antibiotics were clarithromycin 10.5 % , amoxicillin 0 % , and metronidazole 44.2 % of patients , respectively .
RESULTS	The dual resistance rate of clarithromycin and metronidazole was 4.2 % .
RESULTS	Both therapies achieved a high eradication rate for clarithromycin-resistant strains ( 100 % vs 100 % , respectively ) and metronidazole-resistant strains ( 81.8 % vs 95 % , respectively ) by intention-to-treat analysis .
CONCLUSIONS	Ten-day reverse sequential therapy and standard sequential therapy are equally effective for H.Pylori eradication .
CONCLUSIONS	The finding indicates that the sequence of antibiotics administered in sequential therapy does not influence the efficacy of the treatment .

###25897153
OBJECTIVE	The phase III North American Intergroup E2496 Trial ( Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin 's Lymphoma ) compared doxorubicin , bleomycin , vinblastine , and dacarbazine ( ABVD ) with mechlorethamine , doxorubicin , vincristine , bleomycin , vinblastine , etoposide , and prednisone ( Stanford V ) .
OBJECTIVE	We report results of a planned subgroup analysis in patients with stage I or II bulky mediastinal Hodgkin lymphoma ( HL ) .
METHODS	Patients were randomly assigned to six to eight cycles of ABVD every 28 days or Stanford V once per week for 12 weeks .
METHODS	Two to 3 weeks after completion of chemotherapy , all patients received 36 Gy of modified involved field radiotherapy ( IFRT ) to the mediastinum , hila , and supraclavicular regions .
METHODS	Patients on the Stanford V arm received IFRT to additional sites 5 cm at diagnosis .
METHODS	Primary end points were failure-free survival ( FFS ) and overall survival ( OS ) .
RESULTS	Of 794 eligible patients , 264 had stage I or II bulky disease , 135 received ABVD , and 129 received Stanford V. Patient characteristics were matched .
RESULTS	The overall response rate was 83 % with ABVD and 88 % with Stanford V.
RESULTS	At a median follow-up of 6.5 years , the study excluded a difference of more than 21 % in 5-year FFS and more than 16 % in 5-year OS between ABVD and Stanford V ( 5-year FFS : 85 % v 79 % ; HR , 0.68 ; 95 % CI , 0.37 to 1.25 ; P = .22 ; 5-year OS : 96 % v 92 % ; HR , 0.49 ; 95 % CI , 0.16 to 1.47 ; P = .19 ) .
RESULTS	In-field relapses occurred in < 10 % of the patients in each arm .
CONCLUSIONS	For patients with stage I or II bulky mediastinal HL , no substantial statistically significant differences were detected between the two regimens , although power was limited .
CONCLUSIONS	To the best of our knowledge , this is the first prospective trial reporting outcomes specific to this subgroup , and it sets a benchmark for comparison of ongoing and future studies .

###25243839
OBJECTIVE	Hepatic encephalopathy ( HE ) is a common cause of hospitalization in patients with cirrhosis .
OBJECTIVE	Pharmacologic treatment for acute ( overt ) HE has remained the same for decades .
OBJECTIVE	To compare polyethylene glycol 3350-electrolyte solution ( PEG ) and lactulose treatments in patients with cirrhosis admitted to the hospital for HE .
OBJECTIVE	We hypothesized that rapid catharsis of the gut using PEG may resolve HE more effectively than lactulose .
METHODS	The HELP ( Hepatic Encephalopathy : Lactulose vs Polyethylene Glycol 3350-Electrolyte Solution ) study is a randomized clinical trial in an academic tertiary hospital of 50 patients with cirrhosis ( of 186 screened ) admitted for HE .
METHODS	Participants were block randomized to receive treatment with PEG , 4-L dose ( n = 25 ) , or standard-of-care lactulose ( n = 25 ) during hospitalization .
METHODS	The primary end point was an improvement of 1 or more in HE grade at 24 hours , determined using the hepatic encephalopathy scoring algorithm ( HESA ) , ranging from 0 ( normal clinical and neuropsychological assessments ) to 4 ( coma ) .
METHODS	Secondary outcomes included time to HE resolution and overall length of stay .
RESULTS	A total of 25 patients were randomized to each treatment arm .
RESULTS	Baseline clinical features at admission were similar in the groups .
RESULTS	Thirteen of 25 patients in the standard therapy arm ( 52 % ) had an improvement of 1 or more in HESA score , thus meeting the primary outcome measure , compared with 21 of 23 evaluated patients receiving PEG ( 91 % ) ( P < .01 ) ; 1 patient was discharged before final analysis and 1 refused participation .
RESULTS	The mean ( SD ) HESA score at 24 hours for patients receiving standard therapy changed from 2.3 ( 0.9 ) to 1.6 ( 0.9 ) compared with a change from 2.3 ( 0.9 ) to 0.9 ( 1.0 ) for the PEG-treated groups ( P = .002 ) .
RESULTS	The median time for HE resolution was 2 days for standard therapy and 1 day for PEG ( P = .01 ) .
RESULTS	Adverse events were uncommon , and none was definitely study related .
CONCLUSIONS	PEG led to more rapid HE resolution than standard therapy , suggesting that PEG may be superior to standard lactulose therapy in patients with cirrhosis hospitalized for acute HE .
BACKGROUND	clinicaltrials.gov Identifier : NCT01283152 .

###24938661
BACKGROUND	Iosimenol 340 injection is a new , dimeric , iso-osmolar , iodinated contrast medium for X-ray angiography .
OBJECTIVE	To compare the safety and efficacy of iosimenol injection to iodixanol injection in two randomized , controlled phase 2 trials .
METHODS	One hundred and forty-four adult patients were enrolled in the two trials , one for evaluation during arteriography and the other for evaluation during computed tomography .
METHODS	Safety was compared by assessing adverse events , vital signs , ECGs , and laboratory parameters .
METHODS	Efficacy was assessed as X-ray attenuation in the computed tomography ( CT ) trial and as the quality of contrast enhancement in the arteriography trial .
RESULTS	There were no statistically significant differences in terms of safety or efficacy between the two contrast media .
RESULTS	Both were well tolerated upon intravenous as well as intra-arterial injection .
RESULTS	The most common adverse event was a feeling of warmth ( observed in 35.1 % of the patients with Iosimenol injection and 44.3 % with iodixanol injection ) .
CONCLUSIONS	Iosimenol upon intravenous as well as upon intra-arterial injection exhibits a safety profile and shows an efficacy similar to that of iodixanol .

###25675661
BACKGROUND	The harmonic scalpel ( HS ) has been used successfully in several head and neck surgical procedures .
BACKGROUND	Some authors highlighted its advantages in reducing operative time , blood loss , and damages to surrounding tissue .
BACKGROUND	In our study , we compared the results obtained during parotidectomy using the HS with the traditional approach to determine the benefits of the HS .
METHODS	130 patients with benign parotid tumors were enrolled and randomized into two groups for this prospective study .
METHODS	63 patients underwent HS parotidectomy , and 67 patients received a parotidectomy using cold instruments and bipolar electrocautery hemostatic control ( CI ) .
METHODS	20 HS and 2 CI patients did not meet the inclusion criteria requirements , and were excluded .
RESULTS	The admission time was significantly shorter in the HS group than the CI group ( 3.9 1.2 days and 4.7 1.4 days , respectively , p < 0.01 ) .
RESULTS	In the early post-operative period , 84 % of HS patients and 60 % of CI cases showed no facial nerve impairment ( p = 0.01 ) .
RESULTS	Significantly more CI patients than HS patients showed the onset of Frey 's syndrome ( 29 % and 9 % , respectively , p = 0.01 ) .
RESULTS	Multivariate stepwise regression analysis confirmed the reduction in admission length ( Odds Ratio ( OR ) : 0.62 ; p = 0.02 ) and the lower risk of Frey 's syndrome ( OR : 0.29 ; p = 0.04 ) in HS compared to CI parotidectomies .
CONCLUSIONS	In parotid surgery , the HS is useful in preventing Frey 's syndrome and reducing early transitory facial nerve dysfunction and admission times , and results in decreased medical costs and increased quality of life .

###24353047
OBJECTIVE	To evaluate via retrospective analysis the efficacy and tolerability of tapentadol extended release ( ER ; 100-250 mg bid ) based on patient-specific factors , including baseline pain intensity , prior opioid experience , gender , and body mass index ( BMI ) .
METHODS	Data were pooled from three randomized , double-blind phase III studies of similar design that evaluated the efficacy and tolerability of tapentadol ER for the management of moderate to severe , chronic osteoarthritis knee pain ( NCT00421928 , NCT00486811 ) or low back pain ( NCT00449176 ) .
METHODS	In the original trials , patients were recruited at primary , secondary , and tertiary care centers , institutional settings , and private practices in North America , Europe , Australia , and New Zealand .
METHODS	Data were analyzed separately for groups of patients divided by baseline pain intensity , prior opioid experience , gender , and BMI .
METHODS	Patients received twice-daily placebo , tapentadol ER ( 100-250 mg ) , or oxycodone HCl controlled release ( CR ; 20-50 mg ) for a 3-week titration and 12-week maintenance period .
METHODS	Changes from baseline in average pain intensity ( 11-point numerical rating scale ) at week 12 of the maintenance period and for the overall maintenance period .
RESULTS	Efficacy and tolerability were evaluated in 2,968 and 2,974 patients , respectively .
RESULTS	The efficacy of tapentadol ER was shown in subpopulations divided by baseline pain intensity , prior opioid experience , gender , and BMI .
RESULTS	Tapentadol ER was also shown to be well tolerated and associated with better gastrointestinal tolerability than oxycodone CR in the evaluated subpopulations ( divided by prior opioid experience and gender ) .
CONCLUSIONS	Results suggest that tapentadol ER ( 100-250 mg bid ) provides similar pain relief and tolerability , regardless of baseline pain intensity , prior opioid experience , gender , or BMI .

###25439694
BACKGROUND	Primary results from the phase 3 ALSYMPCA trial showed that radium-223 dichloride ( radium-223 ) , a targeted - emitter , improved overall survival compared with placebo and was well tolerated in patients with castration-resistant prostate cancer and symptomatic bone metastases .
BACKGROUND	We did a prespecified subgroup analysis from ALSYMPCA to assess the effect of previous docetaxel use on the efficacy and safety of radium-223 .
METHODS	In the phase 3 , randomised , double-blind ALSYMPCA trial , patients with symptomatic castration-resistant prostate cancer , at least two symptomatic bone metastases , no known visceral metastases , and who were receiving best standard of care were randomly assigned ( 2:1 ) via an interactive voice response system to receive six injections of radium-223 ( 50 kBq/kg intravenously ) or matching placebo , with one injection given every 4 weeks .
METHODS	Patients had either received previous docetaxel treatment or were unsuitable for or declined docetaxel ; previous docetaxel use ( yes or no ) was a trial stratification factor .
METHODS	We investigated the effect of previous docetaxel use on radium-223 treatment for the primary endpoint of overall survival , the main secondary efficacy endpoints , and safety .
METHODS	Efficacy analyses were done for the intention-to-treat population ; safety analyses were done for the safety population .
METHODS	The trial has been completed and is registered with ClinicalTrials.gov , number NCT00699751 .
RESULTS	Randomisation took place between June 12 , 2008 , and Feb 1 , 2011.526 ( 57 % ) of 921 randomly assigned patients had received previous docetaxel treatment ( 352 in the radium-223 group and 174 in the placebo group ) and 395 ( 43 % ) had not ( 262 in the radium-223 group and 133 in the placebo group ) .
RESULTS	Radium-223 prolonged median overall survival compared with placebo , irrespective of previous docetaxel use ( previous docetaxel use , hazard ratio [ HR ] 070 , 95 % CI 056-088 ; p = 0002 ; no previous docetaxel use , HR 069 , 052-092 ; p = 001 ) .
RESULTS	The benefit of radium-223 compared with placebo was seen in both docetaxel subgroups for most main secondary efficacy endpoints ; risk for time to time to first symptomatic skeletal event was reduced with radium-223 versus placebo in patients with previous docetaxel use , but the difference was not significant in those with no previous docetaxel use .
RESULTS	322 ( 62 % ) of 518 patients previously treated with docetaxel had grade 3-4 adverse events , compared with 205 ( 54 % ) of 383 patients without docetaxel .
RESULTS	Patients who had previously been treated with docetaxel had a higher incidence of grade 3-4 thrombocytopenia with radium-223 than with placebo ( 31 [ 9 % ] of 347 patients vs five [ 3 % ] of 171 patients ) , whereas the incidence was similar between treatment groups among patients with no previous docetaxel use ( seven [ 3 % ] of 253 patients vs one [ 1 % ] of 130 patients ) .
RESULTS	The incidences of grade 3-4 anaemia and neutropenia were similar between the radium-223 and placebo groups within both docetaxel subgroups .
CONCLUSIONS	Radium-223 is effective and well tolerated in patients with castration-resistant prostate cancer and symptomatic bone metastases , irrespective of previous docetaxel use .
BACKGROUND	Algeta ASA and Bayer HealthCare Pharmaceuticals .

###25360863
BACKGROUND	The objectives of this study were as follows : ( 1 ) to evaluate frontal sinus ostial patency following balloon dilation with the Ventera Sinus Dilation System , compared with frontal sinusotomy ( Draf 2a ) ; and ( 2 ) to compare mean blood loss and mean surgical time for frontal sinusotomy using balloon dilation compared with traditional surgical methods .
METHODS	A single blinded , randomized , controlled , prospective study was performed at St. Paul 's Sinus Center , Vancouver , a tertiary referral rhinology center .
METHODS	Thirty patients undergoing functional endoscopic sinus surgery ( FESS ) for chronic rhinosinusitis ( CRS ) were randomized to a hybrid approach with exposure of the frontal recess using standard instrumentation and then balloon dilation of 1 frontal sinus drainage pathway and traditional frontal sinusotomy for the opposite side .
METHODS	Blood loss and surgical time for opening the frontal sinus drainage pathway was recorded for each side .
METHODS	Patients acted as their own controls .
METHODS	Ostial patency and size were assessed 5 weeks and 3 months postoperatively using endoscopy .
METHODS	Ostial patency was also recorded at 1 year following surgery .
RESULTS	All frontal sinus ostia in both groups ( n = 30 ) were successfully opened and were patent with both techniques 3 months postoperatively .
RESULTS	All frontal sinus ostia assessed at 1 year ( 73 % ) remained patent and none required revision frontal surgery .
RESULTS	Balloon dilation showed a mean surgical time of 655 seconds compared to 898 seconds for traditional FESS ( p = 0.03 ) .
RESULTS	Mean blood loss was less with balloon dilation ( 58 mL vs 91 mL ; p = 0.008 ) .
CONCLUSIONS	A hybrid balloon technique successfully dilates the frontal sinus drainage pathway with reduced blood loss .
CONCLUSIONS	Also , short-term patency appears to be comparable to traditional frontal sinusotomy .

###25630874
BACKGROUND	Hematopoietic cell transplantation ( HCT ) may be detrimental to bone health and vitamin D status in children .
METHODS	We conducted a prospective , multicenter cohort study to identify changes in bone health markers during the first 100 days after allogeneic HCT in 26 children .
METHODS	Bone mineral density ( BMD ) , bone mineral content ( BMC ) , and serum 25-hydroxyvitamin D ( 25OHD ) concentrations were measured at baseline , 30 days , and 100 days after HCT .
RESULTS	Mean ( SD ) BMD and BMC Z-scores ( -0.48 1.09 and -0.98 1.26 , respectively ) were normal at baseline .
RESULTS	Repeated-measures analysis revealed significant declines in BMD and BMC Z-scores over the 100 day study period , when adjusted for age , sex , Tanner stage , lean mass , fat mass , resting energy expenditure , total energy intake , insulin sensitivity , serum phosphorus , and inpatient steroid intake .
RESULTS	Adjusted mean ( SE ) 25OHD concentrations declined from 29.2 ( 3.1 ) ng/ml at baseline , to 17.7 ( 1.8 ) ng/ml at 100 days after HCT .
RESULTS	Vitamin D deficiency ( 25OHD < 20ng/ml ) was present in 50 % of patients 100 days after HCT .
CONCLUSIONS	Significant bone loss and vitamin D deficiency occur in children in the first 100 days following allogeneic HCT .
CONCLUSIONS	Strategies to diminish acute bone loss during HCT in children are needed .

###25305357
OBJECTIVE	We compared the efficacy and safety of anterior colporrhaphy with transvaginal polypropylene mesh insertion for anterior vaginal wall prolapse at medium term followup .
METHODS	In this prospective , randomized , controlled trial 100 women with stage II or greater anterior vaginal wall prolapse assessed by POP-Q were randomized to anterior colporrhaphy ( controls ) or mesh insertion .
METHODS	Anatomical outcomes were assessed by POP-Q measurement and prolapse stage .
METHODS	Subjective outcomes and quality of life impact were evaluated by ICIQ questionnaires .
METHODS	We evaluated the procedure safety profile according to intraoperative complication rates throughout followup .
RESULTS	In the mesh and control groups 42 and 50 women completed the 24-month followup .
RESULTS	Point Ba did not significantly differ between the groups at baseline but at 24-month followup it had significantly improved in the mesh group compared to controls .
RESULTS	However , no difference was found between the groups when considering 2 cure criteria on prolapse stage and subjective parameters .
RESULTS	Asymptomatic mesh exposure developed on the anterior vaginal wall prolapse in 7 patients ( 16.4 % ) in the mesh group .
RESULTS	Minor mesh related complications consisted of mesh exposure , prepubic ecchymosis and groin pain , of which most were treated conservatively .
RESULTS	Urinary retention was treated surgically .
CONCLUSIONS	Nazca TC and anterior colporrhaphy provided good overall anatomical outcomes during a minimum 24-month followup .
CONCLUSIONS	Vaginal and urinary symptoms , and quality of life improved postoperatively in each group .
CONCLUSIONS	From the patient perspective Nazca TC did not show superior overall outcomes compared to anterior colporrhaphy performed with or without a retropubic sling .

###25482871
BACKGROUND	Severe atopic dermatitis ( AD ) has a high unmet need for effective and safe therapeutics .
BACKGROUND	In early-phase trials , dupilumab , a fully human mAb targeting IL-4 receptor , markedly improved disease activity , but the effect of IL-4 / IL-13 blockade on AD at the molecular level has not been characterized .
OBJECTIVE	We sought to evaluate dupilumab modulation of the AD molecular signature .
METHODS	We performed transcriptomic analyses of pretreatment and posttreatment skin biopsy specimens from patients with moderate-to-severe AD treated weekly with 150 or 300 mg of dupilumab or placebo .
RESULTS	Exacerbation of the AD transcriptome was observed in placebo-treated patients .
RESULTS	Dupilumab improved the AD signature in a dose-dependent manner .
RESULTS	Expression of genes upregulated in AD lesions decreased in patients treated with dupilumab by 26 % ( 95 % CI , 21 % to 32 % ) and 65 % ( 95 % CI , 60 % to 71 % ) for treatment with 150 and 300 mg , respectively .
RESULTS	Genes downregulated in AD lesions increased by 21 % ( 95 % CI , 16 % to 27 % ) and 32 % ( 95 % CI , 26 % to 37 % ) with dupilumab ( 150 and 300 mg , respectively ) .
RESULTS	The molecular changes paralleled improvements in clinical scores .
RESULTS	Adupilumab treatment signature of 821 probes ( > 2-fold change , P < .05 ) significantly modulated in the 300-mg dupilumab group at week 4 compared with baseline was identified in this sample set .
RESULTS	Significant ( P < .05 ) decreases in mRNA expression of genes related to hyperplasia ( K16 and MKI67 ) , T cells , and dendritic cells ( CD1b and CD1c ) and potent inhibition of TH2-associated chemokines ( CCL17 , CCL18 , CCL22 , and CCL26 ) were noted without significant modulation of TH1-associated genes ( IFNG ) .
CONCLUSIONS	This is the first report showing rapid improvement of the AD molecular signature with targeted anti-IL-4 receptor therapy .
CONCLUSIONS	These data suggest that IL-4 and IL-13 drive a complex , TH2-centered inflammatory axis in patients with AD .

###24398649
OBJECTIVE	We assessed the effect of cholecalciferol and calcium supplementation on mRNA expression of cathelicidin ( LL-37 ) , Th1 and Th2 cytokines and their transcription factors in the peripheral blood mononuclear cells ( PBMCs ) in healthy females with vitamin D deficiency ( VDD ) .
METHODS	Subjects included 131 females with biochemical VDD randomized to receive ( a ) oral cholecalciferol ( 60,000 IU/week for 8 weeks followed by 60,000 IU/fortnight ( b ) calcium ( elemental calcium 500 mg twice/day ) ( c ) , dual supplementation and ( d ) placebo for 6 months .
METHODS	The mRNA expression of cathelicidin , Th1 ( IFN - ) and Th2 ( IL-4 and its antagonist-IL-42 ) cytokines and their transcription factors ( T-bet , STAT4 , GATA-3 , STAT6 ) were measured in the PBMC by real-time PCR before and after intervention .
RESULTS	Cholecalciferol-supplemented groups showed significant rise of mean serum 25 ( OH ) D ( 30.6 7.51 and 28.6 8.41 ng/ml ) .
RESULTS	The expression of LL-37 , IFN - , IL-4 , IL-42 and transcription factors were comparable in the four groups at baseline .
RESULTS	Despite significant increase in mean serum 25 ( OH ) D in the cholecalciferol-supplemented groups , their mean mRNA transcripts of LL-37 , IFN - , IL-4 , transcription factors and their IFN - / IL-4 and T-bet/GATA -3 ratios were similar to that of calcium and placebo groups .
CONCLUSIONS	Six months of cholecalciferol/calcium supplementation in young females with VDD do not lead to significant alteration in mRNA expression of LL-37 , Th1/Th2 cytokines and their transcription factors .

###24553909
OBJECTIVE	Evaluate ustekinumab , an anti-interleukin ( IL ) -12 and IL-23 antibody , effects on radiographic progression in psoriatic arthritis ( PsA ) .
METHODS	We conducted preplanned integrated analyses of combined radiographic data from PSUMMIT-1 and PSUMMIT-2 phase 3 , randomised , controlled trials .
METHODS	Patients had active PsA despite prior conventional and/or biologic disease-modifying antirheumatic drugs ( 5/66 swollen , 5/68 tender joints , C-reactive protein 3.0 mg/L , documented plaque psoriasis ) .
METHODS	Patients ( PSUMMIT-1 , n = 615 ; PSUMMIT-2 , n = 312 ) were randomised to ustekinumab 45 mg , 90 mg , or placebo , at weeks ( wk ) 0 , 4 and every ( q ) 12 wks .
METHODS	At wk 16 , patients with < 5 % improvement in tender/swollen joint counts entered blinded early escape .
METHODS	All other placebo patients received ustekinumab 45 mg at wk 24 and wk 28 , then q 12 wks .
METHODS	Radiographs of hands/feet at wks 0/24/52 were assessed using PsA-modified van der Heijde-Sharp ( vdH-S ) scores ; combined PSUMMIT-1 and PSUMMIT-2 changes in total vdH-S scores from wk 0 to wk 24 comprised the prespecified primary radiographic analysis .
METHODS	Treatment effects were assessed using analysis of variance on van der Waerden normal scores ( factors = treatment , baseline methotrexate usage , and study ) .
RESULTS	Integrated data analysis results indicated that ustekinumab-treated patients ( regardless of dose ) demonstrated significantly less radiographic progression at wk 24 than did placebo recipients ( wk 0-24 total vdH-S score mean changes : 0.4-combined / individual ustekinumab dose groups , 1.0-placebo ; all p < 0.02 ) .
RESULTS	From wk 24 to wk 52 , inhibition of radiographic progression was maintained for ustekinumab-treated patients , and progression was substantially reduced among initial placebo recipients who started ustekinumab at wk 16 or wk 24 ( wk 24 - wk 52 , total vdH-S score mean change : 0.08 ) .
CONCLUSIONS	Ustekinumab 45 and 90 mg treatments significantly inhibited radiographic progression of joint damage in patients with active PsA .

###24596968
BACKGROUND	Obesity is one of the greatest public health challenges world wide and its prevalence has increased during the past 20-30 years .
BACKGROUND	Obesity is related to physical and mental health and increased mortality .
BACKGROUND	There are few evidence-based treatment options for the obese available in Iceland .
METHODS	The purpose of this pilot study was to develop a 15 week group program based on Cognitive Behavior Therapy and Appetite Awareness Training for young obese women .
METHODS	The participants were randomly allocated to two groups , A and B , in a convenience sample of 20 women , aged 19-44 with a BMI 30-39 .9 kg/m .
METHODS	Group A attended the program while group B served as a control in a crossover design where group B subsequently participated in the program .
METHODS	The effectiveness of the program was evaluated before , during and at the end of the program and at six and twelve month follow-up .
METHODS	Information was collected on body weight , BMI , body fat and body fat mass , blood pressure , cholesterol , triglyceride , high density lipoprotein and 25 ( OH ) D , quality of life ( SF-36 and OP scale ) , symptoms of depression ( BDI-II ) and anxiety ( BAI ) .
METHODS	Additionally participants completed a questionnaire on demographics and their view on participating in the program was assessed .
RESULTS	Participants reduced their weight ( P = 0.001 ) , BMI ( P = 0.001 ) , body fat ( P = 0.010 ) , body fat mass ( P = 0.002 ) , diastolic blood pressure ( P = 0.005 ) and vitamin D status improved ( P = 0.008 ) .
RESULTS	Symptoms of depression and anxiety decreased ( P < 0.001 and P < 0.004 ) .
RESULTS	Quality of life measured with OP scale improved ( P = 0.006 ) and the mental component summary ( MCS ) ( P = 0.012 ) of the SF-36 scale .
RESULTS	The mean weight loss was 3.7 kg following intervention which was maintained at follow up .
CONCLUSIONS	`` The enjoy eating '' program is a promising health promotion approach in the health care sector for obese women to improve mental health , quality of life and loose weight .

###26148947
OBJECTIVE	More than 200 million children globally do not attain their developmental potential .
OBJECTIVE	We hypothesized that a parent training program could be integrated into primary health center visits and benefit child development .
METHODS	We conducted a cluster randomized trial in the Caribbean ( Jamaica , Antigua , and St Lucia ) .
METHODS	Fifteen centers were randomly assigned to the control ( n = 250 mother-child pairs ) and 14 to the intervention ( n = 251 mother-child pairs ) groups .
METHODS	Participants were recruited at the 6 - to 8-week child health visit .
METHODS	The intervention used group delivery at 5 routine visits from age 3 to 18 months and comprised short films of child development messages , which were shown in the waiting area ; discussion and demonstration led by community health workers ; and mothers ' practice of activities .
METHODS	Nurses distributed message cards and a few play materials .
METHODS	Primary outcomes were child cognition , language , and hand-eye coordination and secondary outcomes were caregiver knowledge , practices , maternal depression , and child growth , measured after the 18-month visit .
RESULTS	Eight-five percent of enrolled children were tested ( control = 210 , intervention = 216 ) .
RESULTS	Loss did not differ by group .
RESULTS	Multilevel analyses showed significant benefits for cognitive development ( 3.09 points ; 95 % confidence interval : 1.31 to 4.87 points ; effect size : 0.3 SDs ) .
RESULTS	There were no other child benefits .
RESULTS	There was a significant benefit to parenting knowledge ( treatment effect : 1.59 ; 95 % confidence interval : 1.01 to 2.17 ; effect size : 0.4 ) .
CONCLUSIONS	An innovative parenting intervention , requiring no additional clinic staff or mothers ' time , was integrated into health services , with benefits to child cognitive development and parent knowledge .
CONCLUSIONS	This is a promising strategy that merits further evaluation at scale .

###24286542
OBJECTIVE	To explore the effect of ear acupressure in relieving perineal pain in women during the first 48 hours after delivery .
BACKGROUND	Perineal pain is a common problem during postpartum , and different treatment modalities have been used for relief .
BACKGROUND	Ear acupressure has been reported to have possible benefit on relieving acute postpartum perineal pain .
METHODS	This study was designed as a prospective , randomised controlled trial .
METHODS	Chinese women with a singleton vertex foetus at the gestation of 37 weeks or above were recruited .
METHODS	One hundred and twenty six and 130 women were randomised into the intervention and control groups , respectively .
METHODS	Women in the intervention group received application of tapes and seeds on four designated acupressure points on both ears , while women in the control group received tapes on four irrelevant points .
METHODS	Both groups were instructed to stimulate the points in a similar fashion .
METHODS	Pain perception was assessed by the Verbal Descriptive Pain Scale and the Visual Analogue Scale , and the consumption of analgesics was also reviewed .
RESULTS	No significant difference in perineal pain perception between the groups was observed in Verbal Descriptive Pain Scale .
RESULTS	Although the mean Visual Analogue Scale and the accumulative mean consumption of paracetamol were generally lower in the intervention group , statistical significance was not reached .
CONCLUSIONS	There is no evidence so far to conclude that ear acupressure can effectively relieve perineal pain based on the statistical results .
CONCLUSIONS	Further research is suggested to explore whether the effectiveness of pain relief is affected by the frequency and duration of acupressure point stimulation .
CONCLUSIONS	Training of midwives to perform this intervention is easy to achieve , but further evidence is required to prove its effectiveness .

###24238518
BACKGROUND	A wealth of evidence has indicated that labor epidural analgesia is associated with an increased risk of hyperthermia and overt clinical fever .
BACKGROUND	Recently , evidence is emerging that the epidural analgesia-induced fever is associated with the types of the epidural analgesia and the variations in the epidural analgesia will affect the incidence of fever .
BACKGROUND	The aim of the present study was to investigate the effects of epidural analgesia with 0.075 % or 0.1 % ropivacaine on the maternal temperature during labor .
METHODS	Two hundred healthy term nulliparas were randomly assigned to receive epidural analgesia with either 0.1 % ropivacaine or 0.075 % ropivacaine .
METHODS	Epidural analgesia was initiated with 10 ml increment of the randomized solution and 0.5 g/ml sufentanyl after a negative test dose of 5 ml of 1.5 % lidocaine , and maintained with 7 ml bolus doses of the above mentioned mixed analgesics every 30 minutes by the patient-controlled epidural analgesia .
METHODS	The measurements included the maternal oral temperature , visual analog scale pain scores , labor events and neonatal outcomes .
RESULTS	Epidural analgesia with 0.075 % ropivacaine could significantly lower the mean maternal temperature at 4 hours after the initiation of analgesia and the oxytocin administration during labor compared with the one with 0.1 % ropivacaine .
RESULTS	Moreover , 0.075 % ropivacaine treatment could provide satisfactory pain relief during labor and had no significant adverse effects on the labor events and neonatal outcomes .
CONCLUSIONS	Epidural analgesia with 0.075 % ropivacaine may be a good choice for the epidural analgesia during labor .

###25102461
OBJECTIVE	To evaluate the clinical and radiological response of primary molars to direct pulp capping with calcium sulfate hemihydrate .
METHODS	Forty primary molar teeth in 40 healthy children aged 5-9 years were treated by direct pulp capping .
METHODS	Teeth were randomly assigned to two groups ( n = 20 ) according to material used for capping , as follows : Group 1 : calcium hydroxide cement ( Dycal ) ; Group 2 : calcium sulfate hemihydrate ( Dentogen ) .
METHODS	All teeth were restored with a conventional glass ionomer base ( Fuji IX ) and amalgam .
RESULTS	After 12 months , the overall success rate of direct pulp capping was approximately 75 % ( 24/32 teeth , excluding exfoliations ) .
RESULTS	The success rate did not differ significantly between calcium hydroxide and calcium sulfate hemihydrate treatment .
CONCLUSIONS	Calcium sulfate hemihydrate was found to be as successful as calcium hydroxide for direct pulp capping of primary molars with Class I cavities .
CONCLUSIONS	Further histological studies are needed to support these findings .

###24552888
BACKGROUND	Blacks have a higher prevalence of risk factors for atrial fibrillation ( AF ) , such as hypertension , obesity , and heart failure , than nonblacks .
BACKGROUND	Although population-based studies have demonstrated a lower prevalence and incidence of AF in blacks , the relationship of incident AF to race among hypertensive patients undergoing blood pressure lowering has been less extensively examined .
METHODS	Incident AF was examined in 518 black and 8,313 nonblack hypertensive patients with electrocardiographic left ventricular hypertrophy ( LVH ) with no history of AF in sinus rhythm on their baseline electrocardiogram , who were randomly assigned to losartan - or atenolol-based treatment .
RESULTS	During a mean of 4.71.1 years of follow-up , new-onset AF occurred in 701 patients ( 7.9 % ) ; 5-year AF incidence was significantly lower in black than nonblack patients ( 6.1 vs. 8.3 % ; P = 0.03 ) .
RESULTS	In univariable Cox analyses , black race was associated with a 37 % lower risk of new AF ( hazard ratio ( HR ) = 0.63 ; 95 % confidence interval ( CI ) = 0.45-1 .00 ; P = 0.05 ) .
RESULTS	In multivariable Cox analyses adjusting for randomized treatment , age , sex , diabetes , history of heart failure , myocardial infarction , ischemic heart disease , stroke , peripheral vascular disease , smoking status , baseline body mass index , serum total and high-density lipoprotein cholesterol , creatinine , glucose , and urine albumin/creatinine ratio as standard risk factors , and for incident myocardial infarction , in-treatment heart rate , systolic and diastolic pressure , Cornell product , and Sokolow-Lyon voltage LVH treated as time-varying covariables , black race remained associated with a 45 % decreased risk of developing new AF ( HR = 0.55 ; 95 % CI = 0.35-0 .87 ; P = 0.01 ) .
CONCLUSIONS	Incident AF is substantially less common among black than nonblack hypertensive patients .

###25834076
BACKGROUND	For children with upper-extremity cerebral palsy ( CP ) who meet standard indications for tendon transfer surgery , we hypothesized that surgical treatment would result in greater functional improvement than treatment with botulinum toxin injections or regular , ongoing therapy .
METHODS	Thirty-nine children with upper-extremity CP , who were four to sixteen years of age and surgical candidates for the transfer of the flexor carpi ulnaris to the extensor carpi radialis brevis , pronator teres release , and extensor pollicis longus rerouting with adductor pollicis release , were prospectively assigned , either randomly ( twenty-nine patients ) or by patient/family preference ( ten patients ) , to one of three treatment groups : surgical treatment ( Group 1 ) ; botulinum toxin injections ( Group 2 ) ; or regular , ongoing therapy ( Group 3 ) .
METHODS	Seven centers participated .
METHODS	Assessment measurements included active range of motion , pinch and grip strength , stereognosis , and scores as measured with eight additional functional or patient-oriented outcome instruments .
METHODS	Thirty-four patients ( twenty-five randomized and nine from the patient-preference arm ) were evaluated twelve months post-treatment as the study cohort .
RESULTS	For the primary outcome of the Shriners Hospital Upper Extremity Evaluation ( SHUEE ) dynamic positional analysis ( DPA ) , significantly greater improvement was seen in Group 1 than in the other two groups ( p < 0.001 ) .
RESULTS	Improvements in SHUEE DPA reflected improved supination and wrist extension during functional activities after surgical treatment .
RESULTS	Group 1 showed more improvement in the Pediatric Quality of Life Inventory ( PedsQL ) CP module domain of movement and in the Canadian Occupational Performance Measure ( COPM ) score for satisfaction than Groups 2 and 3 .
RESULTS	Both Groups 1 and 3 showed more improvement in pinch strength than did Group 2 .
CONCLUSIONS	For children with upper-extremity CP who were candidates for standard tendon transfer , surgical treatment was demonstrated to provide greater improvement , of modest magnitude , than botulinum toxin injections or regular , ongoing therapy at twelve months of follow-up for the SHUEE DPA , the PedsQL CP module domain of movement , and COPM satisfaction .

###24428904
BACKGROUND	Urban schools lag behind non-urban schools in attending to the behavioral health needs of their students .
BACKGROUND	This is especially evident with regard to the level of use of evidence-based interventions with school children .
BACKGROUND	Increased used of evidence-based interventions in urban schools would contribute to reducing mental health services disparities in low-income communities .
BACKGROUND	School-wide positive behavioral interventions and supports ( SWPBIS ) is a service delivery framework that can be used to deliver universal preventive interventions and evidence-based behavioral health treatments , such as group cognitive behavioral therapy .
BACKGROUND	In this article , we describe our ongoing research on creating internal capacity for program implementation .
BACKGROUND	We also examine the cost-effectiveness and resulting school climate when two different levels of external support are provided to personnel as they implement a two-tier SWPBIS program .
METHODS	The study follows six K - 8 schools in the School District of Philadelphia randomly assigned to consultation support or consultation-plus-coaching support .
METHODS	Participants are : approximately 48 leadership team members , 180 school staff and 3,900 students in Tier 1 , and 12 counselors , and 306 child participants in Tier 2 .
METHODS	Children who meet inclusion criteria for Tier 2 will participate in group cognitive behavioral therapy for externalizing or anxiety disorders .
METHODS	The study has three phases , baseline/training , implementation , and sustainability .
METHODS	We will measure implementation outcomes , service outcomes , child outcomes , and cost .
CONCLUSIONS	Findings from this study will provide evidence as to the appropriateness of school-wide prevention and treatment service delivery models for addressing services disparities in schools .
CONCLUSIONS	The effectiveness and cost-effectiveness analyses of the two levels of training and consultation should help urban school districts and policymakers with the planning and deployment of cost-effective strategies for the implementation of evidence-based interventions for some of the most common behavioral health problems in school children .
BACKGROUND	ClinicalTrials.gov identifier : NCT01941069 .

###25826326
OBJECTIVE	Topical nonsteroidal antiinflammatory drugs ( NSAIDs ) are administered topically for a variety of ophthalmologic conditions .
OBJECTIVE	Brand diclofenac and brand ketorolac were previously shown to have topical anesthetic effects in addition to analgesic effects .
OBJECTIVE	Using the same method , we measured similar anesthetic effects of the 4 currently available topical NSAIDs -- generic diclofenac , generic ketorolac , brand bromfenac , and brand nepafenac .
METHODS	Baseline corneal sensitivity was measured on 10 healthy adult volunteers with a Cochet-Bonnet esthesiometer .
METHODS	One drop of the agent being studied was applied to the right eye every 5 minutes for a total of 4 drops .
METHODS	Corneal sensitivity was measured immediately after the last topical application and every 15 minutes for 60 minutes .
METHODS	After a 1-week washout period , a different agent was studied until all 4 NSAIDs were evaluated .
RESULTS	Corneal sensitivity profiles over time were similar for all NSAIDs .
RESULTS	Corneal sensitivity decreased significantly from baseline immediately after topical application remaining flat from 0 to 30 minutes and then rising from 45 to 60 minutes back toward baseline in all treatment groups ( P < 0.001 ) .
RESULTS	The maximal absolute drop in corneal sensitivity as measured by pressure thresholds was greatest for diclofenac [ 28.6 mm ( 95 % confidence intervals { CI } , 19.8-37 .4 ) ] , followed by ketorolac [ 21.1 mm ( 95 % CI , 15.1-27 .1 ) ] , bromfenac [ 16.9 mm ( 10.7-23 .1 ) ] , and nepafenac [ 16.4 mm ( 95 % CI , 12.7-20 .1 ) ] .
RESULTS	Only diclofenac and nepafenac were statistically different in maximal decrease in sensitivity .
CONCLUSIONS	All 4 currently available NSAIDs demonstrated anesthetic effects similar to brand diclofenac and brand ketorolac .

###25876344
OBJECTIVE	To compare the difference in clinical efficacy on polycystic ovary syndrome ( PCOS ) between electroacupuncture ( EA ) and dyne-35 and to explore the effect mechanism .
METHODS	Sixty-five patients were randomized into an EA group ( 33 cases ) and a western medication group ( 32 cases ) .
METHODS	In the EA group , the selected acupoints were Danzhong ( CV 17 ) , Qimen ( LR 14 ) , Zhongwan ( CV 12 ) , Tianshu ( ST 25 ) , Guanyuan ( CV 4 ) , Zigong ( EX-CA 1 ) , Sanyinjiao ( SP 6 ) , Zusanli ( ST 36 ) and Taichong ( LR 3 ) , etc. .
METHODS	After the arrival of qi , electric stimulation was attached to the acupoints for 30 min .
METHODS	The treatment was given 3 times a week .
METHODS	In the western medication group , dyne-35 was prescribed on the 5th day of natural menstruation or withdrawal bleeding , one tablet a day , continuously for 21 days .
METHODS	The treatment cycle was 3 months in the two groups .
METHODS	The menstrual condition , body mass , body mass index ( BMI ) , serum testosterone ( T ) , luteinizing hormone ( LH ) , follicle-stimulating hormone ( FSH ) and LH/FSH were compared before and after treatment in the two groups .
METHODS	The clinical efficacy was assessed in the two groups .
RESULTS	The total effective rate was 90.6 % ( 29/32 ) in the EA group and was 93.3 % ( 28/30 ) in the western medication group .
RESULTS	The efficacy was similar in the two groups ( P > 0.05 ) .
RESULTS	After treatment , the levels of LH and LH/FSH were all reduced significantly in the two groups ( all P < 0.01 ) .
RESULTS	After treatment , T level in serum was reduced apparently in the western medication group ( P < 0.05 ) .
RESULTS	Before and after treatment , the differences in body mass and BMI in the EA group were more significant than those in the western medication group ( P < 0.01 , P < 0.05 ) .
CONCLUSIONS	EA is the effective method for PCOS , similar to that of dyne-35 .
CONCLUSIONS	The effect of it for weight loss is superior to dyne-35 and no apparent adverse reactions happen .
CONCLUSIONS	The effect mechanism of EA is related to the regulation of serum sexual hormone levels and their ratio , as well as to the regulation of body lipid metabolism .

###24247760
BACKGROUND	Nonpathogenic Escherichia coli strain Nissle 1917 ( EcN ) has immunomodulatory properties and can act on different cells which are important for the allergic immune response .
BACKGROUND	Herein , we investigated the efficacy and tolerability of EcN in subjects with grass pollen-dependent allergic rhinoconjunctivitis .
METHODS	Grass pollen-allergic subjects were randomly allocated to receive EcN in a double-blind , placebo-controlled manner .
METHODS	The treatment was performed from 2 months before onset until the end of one grass pollen season ( in total : 6 months ) .
METHODS	The clinical symptom score and the intake of symptomatic medications were assessed .
METHODS	A skin prick test and grass pollen-specific immunoglobulin ( Ig ) E and IgA were evaluated before and after treatment .
RESULTS	Our results show that coseasonal treatment with EcN in grass pollen-allergic subjects was not superior to placebo as assessed using the symptom-medication score ( p = 0.257 ) .
RESULTS	Interestingly , an increase [ median ( range ) ] in grass pollen-specific IgA was detectable in the EcN group [ 20,556 LU/ml ( 1,812-60 ,800 ) ] versus placebo [ 5,246 LU/ml ( 944-50 ,467 ) ] ( p = 0.048 ) .
CONCLUSIONS	The results indicate that 6 months of coseasonal nonspecific immunomodulation by EcN is not sufficient to achieve clinical efficacy in grass pollen-allergic subjects .
CONCLUSIONS	Future approaches in which such immunomodulators are combined with an allergen-specific protocol might enhance the clinical efficacy of the allergen-specific treatment .

###24800234
BACKGROUND	Evidence is accumulating that circulating tumor cells ( CTC ) out of peripheral blood can serve as prognostic marker not only in metastatic but also in early breast cancer ( BC ) .
BACKGROUND	Various methods are available to detect CTC .
BACKGROUND	Comparisons between the different techniques , however , are rare .
METHODS	We evaluate two different methods for CTC enrichment and detection in primary BC patients : the FDA-approved CellSearch System ( CSS ; Veridex , Warren , USA ) and a manual immunocytochemistry ( MICC ) .
METHODS	The cut-off value for positivity was 1 CTC .
RESULTS	The two different nonoverlapping patient cohorts evaluated with one or the other method were well balanced regarding common clinical parameters .
RESULTS	Before adjuvant CHT 21.1 % ( 416 out of 1972 ) and 20.6 % ( 247 out of 1198 ) of the patients were CTC-positive , while after CHT 22.5 % ( 359 out of 1598 ) and 16.6 % ( 177 out of 1066 ) of the patients were CTC-positive using CSS or MICC , respectively .
RESULTS	CTC positivity rate before CHT was thus similar and not significantly different ( P = 0.749 ) , while CTC positivity rate immediately after CHT was significantly lower using MICC compared to CSS ( P < 0.001 ) .
CONCLUSIONS	Using CSS or MICC for CTC detection , we found comparable prevalence of CTC before but not after adjuvant CHT .

###25163483
BACKGROUND	Older adults in nursing home and home-care are a particularly high-risk population for weight loss or poor nutrition .
BACKGROUND	One negative consequence of undernutrition is increased health care costs .
BACKGROUND	Several potentially modifiable nutritional risk factors increase the likelihood of weight loss or poor nutrition .
BACKGROUND	Hence a structured and multidisciplinary approach , focusing on the nutritional risk factors and involving e.g. dieticians , occupational therapists , and physiotherapist , may be necessary to achieve benefits .
BACKGROUND	Up till now a few studies have been done evaluating the cost-effectiveness of nutritional support among undernourished older adults and none of these have used such a multidisciplinary approach .
METHODS	An 11week cluster randomized trial to assess the cost-effectiveness of multidisciplinary nutritional support for undernutrition in older adults in nursing home and home-care , identified by screening with the Eating validation Scheme .
METHODS	Before start of the study there will be performed a train-the-trainer intervention involving educated nutrition coordinators.In addition to the nutrition coordinator , the participants assigned to the intervention group strategy will receive multidisciplinary nutrition support .
METHODS	Focus will be on treatment of the potentially modifiable nutritional risk factors identified by screening , by involving physiotherapist , registered dietician , and occupational therapist , as relevant and independent of the municipality 's ordinary assessment and referral system.The primary outcome parameter will be change in quality of life ( by means of Euroquol-5D-3L ) .
METHODS	Secondary outcomes will be : physical performance ( chair stand ) , nutritional status ( weight , Body Mass Index and hand-grip strength ) , oral care , fall incidents , hospital admissions , rehabilitation stay , moving to nursing homes ( for participants from home-care ) , use of social services and mortality.An economic evaluation will be conducted to evaluate the cost-effectiveness of the multidisciplinary support.Furthermore , interviews with nursing home and home-care management , nursing staff and nutrition coordinators in both the control and intervention groups , participants in the intervention group and the involved multidisciplinary team will be performed .
CONCLUSIONS	In this study we will evaluate in a randomized controlled trial whether multidisciplinary nutritional support is cost-effective , in undernourished older adults in home-care and nursing home and contribute to important research .
BACKGROUND	ClinicalTrials.gov 2013 NCT01873456 .

###25400470
OBJECTIVE	To investigate the effect of Lactobacillus-containing commercially available probiotic formulations in Germany during antibiotic treatment with an analysis of cost-efficiency .
METHODS	In an observational study , we analyzed the frequency of bowel movements from 258 patients with infections in a primary care hospital in western Germany ; 107 of the patients were offered a probiotic drink containing at least 10 billion cultures of Lactobacillus casei DN 114001 b.i.d.
METHODS	The economic analysis was based on the costs of patient isolation vs preventive intake of probiotics .
METHODS	In a second pilot study , two commercially available probiotic drinks with different Lactobacillus casei strains were directly compared in 60 patients in a randomized controlled fashion .
RESULTS	In the first study , the incidence of antibiotic-associated diarrhea ( AAD ) was significantly reduced in the intervention group ( 6.5 % vs 28.4 % ) , and the duration of AAD in days was significantly shorter ( 1.7 1.1 vs 3.1 2.1 ) .
RESULTS	Higher age and creatinine and lower albumin were identified as risk factors for AAD .
RESULTS	Ampicillin was the antibiotic with the highest rate of AAD ( 50 % ) and with the greatest AAD reduction in the probiotic group ( 4.2 % , relative risk reduction 92 % ) .
RESULTS	The economic analysis showed a cost advantage of nearly 60000 / year in a department of this size .
RESULTS	The second study confirmed the preventive effect of the drink with Lactobacillus casei DN114001 ; however , there were no advantages found for the other tested probiotic drink containing Lactobacillus casei Shirota .
CONCLUSIONS	In contrast to a drink containing Lactobacillus casei Shirota , a commercially available probiotic drink containing Lactobacillus casei DN 114001 cost-efficiently reduces the prevalence of AAD during antibiotic treatment .

###24388920
OBJECTIVE	In vitro data and pilot data suggest that green tea catechins may possess chemopreventive activity for cervical cancer and precursor lesions .
OBJECTIVE	We conducted a randomized , double-blind , placebo-controlled trial of Polyphenon E ( decaffeinated and enriched green tea catechin extract ) in women with persistent human papillomavirus ( HPV ) infection and low-grade cervical intraepithelial neoplasia ( CIN1 ) to evaluate the potential of Polyphenon E for cervical cancer prevention .
METHODS	Ninety-eight eligible women were randomized to receive either Polyphenon E ( containing 800 mg epigallocatechin gallate ) or placebo once daily for 4 months .
METHODS	The primary study outcome was oncogenic HPV clearance and clearance of CIN1 .
RESULTS	Polyphenon E was shown to be acceptable , safe and well tolerated .
RESULTS	There was no difference in the response rate by treatment allocation .
RESULTS	Complete response , defined as negative for high-risk HPV and normal histopathology , was noted in 7 ( 17.1 % ) and 6 ( 14.6 % ) women in the Polyphenon E and placebo arms , respectively .
RESULTS	Progression , defined as persistent oncogenic HPV with histopathologic evidence of progression , was more common in the Polyphenon E group than in the placebo group [ 6 ( 14.6 % ) vs. 3 ( 7.7 % ) ] .
CONCLUSIONS	Based on the largest randomized placebo-controlled trial of a green tea extract for HPV related cervical disease , we conclude that 4 months of Polyphenon E intervention did not promote the clearance of persistent high-risk HPV and related CIN1 .
CONCLUSIONS	Further studies may be necessary to better delineate the risk factors for persistent HPV infection and biology of the disease to facilitate the evaluation of chemopreventive strategies .

###24295613
BACKGROUND	The prevalence of central venous catheters ( CVCs ) for hemodialysis remains high and , despite infection-control protocols , predisposes to bloodstream infections ( BSIs ) .
METHODS	Stratified , cluster-randomized , quality improvement initiative .
METHODS	All in-center patients with a CVC within 211 facility pairs matched by region , facility size , and rate of positive blood cultures ( January to March 2011 ) at Fresenius Medical Care , North America .
METHODS	Incorporate the use of 2 % chlorhexidine with 70 % alcohol swab sticks for exit-site care and 70 % alcohol pads to perform `` scrub the hubs '' in dialysis-related CVC care procedures compared to usual care .
RESULTS	The primary outcome was positive blood cultures for estimating BSI rates .
METHODS	Comparison of 3-month baseline period from April 1 to June 30 and follow-up period from August 1 to October 30 , 2011 .
RESULTS	Baseline BSI rates were similar ( 0.85 vs 0.86 / 1,000 CVC-days ) , but follow-up rates differed at 0.81 / 1,000 CVC-days in intervention facilities versus 1.04 / 1,000 CVC-days in controls ( P = 0.02 ) .
RESULTS	Intravenous antibiotic starts during the follow-up period also were lower , at 2.53 / 1,000 CVC-days versus 3.15 / 1,000 CVC-days in controls ( P < 0.001 ) .
RESULTS	Cluster-adjusted Poisson regression confirmed 21 % -22 % reductions in both ( P < 0.001 ) .
RESULTS	Extended follow-up for 3 successive quarters demonstrated a sustained reduction of bacteremia rates for patients in intervention facilities , at 0.50 / 1,000 CVC-days ( 41 % reduction ; P < 0.001 ) .
RESULTS	Hospitalizations due to sepsis during 1-year extended follow-up were 0.19 / 1,000 CVC-days ( 0.069 / CVC-year ) versus 0.26 / 1,000 CVC-days ( 0.095 / CVC-year ) in controls ( 27 % difference ; P < 0.05 ) .
CONCLUSIONS	Inability to capture results from blood cultures sent to external laboratories , underestimation of sepsis-specific hospitalizations , and potential crossover adoption of the intervention protocol in control facilities .
CONCLUSIONS	Adoption of the new catheter care procedure ( consistent with Centers for Disease Control and Prevention recommendations ) resulted in a 20 % lower rate of BSIs and intravenous antibiotic starts , which were sustained over time and associated with a lower rate of hospitalizations due to sepsis .

###25414430
OBJECTIVE	Vitamin D insufficiency is common in primary hyperparathyroidism ( pHPT ) .
OBJECTIVE	Patients with pHPT frequently have a reduced health-related quality of life ( HRQoL ) .
OBJECTIVE	Our objectives were to evaluate whether HRQoL in pHPT is associated with vitamin D insufficiency and whether vitamin D supplementation after parathyroidectomy ( PTX ) could improve HRQoL .
METHODS	A randomized , double-blind study ( ClinicalTrials.gov identifier : NCT00982722 ) .
METHODS	The study included 150 pHPT patients randomized , 6 weeks after PTX , to daily treatment with either cholecalciferol 1600IU and calcium carbonate 1000mg ( D + ) or calcium carbonate alone ( D - ) .
METHODS	HRQoL was estimated with SF-36 before and after PTX and after 12 months of study medication .
RESULTS	Three-quarters ( 77 % ) of the pHPT patients had vitamin D insufficiency , defined as 25OHD < 50nmol/l .
RESULTS	The pHPT patients scored lower than a reference population in all domains of SF-36 .
RESULTS	A total of 135 patients completed the entire study period .
RESULTS	Improvements in nearly all domains were registered at the follow-up 6 weeks after PTX .
RESULTS	At the end of the study medication period , the D + group had a significantly higher median serum ( s - ) 25OHD concentration ( 76 ( 65 ; 93 ) ( lower ; upper interquartile ranges ) vs 48 ( 40 ; 62 ) nmol/l , P < 0.001 ) and a lower plasma ( p - ) parathyroid hormone concentration ( 40 ( 34 ; 52 ) vs 49 ( 38 ; 66 ) ng/l , P = 0.01 ) than the D - group .
RESULTS	The improvements in HRQoL remained unchanged at the follow-up 1 year after PTX .
RESULTS	Postoperative vitamin D supplementation had no obvious effect on HRQoL .
CONCLUSIONS	PTX resulted in significant improvements in HRQoL .
CONCLUSIONS	Despite a high prevalence of vitamin D insufficiency , 1 year of postoperative vitamin D supplementation had no obvious beneficial effect on HRQoL .

###24781517
BACKGROUND	Pilot study results suggested that a new form of nicotine oral soluble film relieved smoking cue-provoked acute craving faster than nicotine lozenge or gum .
BACKGROUND	The new nicotine film may provide smokers another choice to relieve acute craving .
OBJECTIVE	This study compared the efficacy of the 2.5 mg nicotine oral soluble film to 2mg nicotine lozenge for acute relief of smoking cue-provoked craving .
METHODS	A randomized , open label , active comparator controlled , parallel group study was conducted with 322 smokers enrolled .
METHODS	After 4h of abstinence from smoking , eligible subjects were exposed to smoking cues as provocation .
METHODS	Immediately after the post-provocation baseline craving assessment using a 0-100mm visual analogue scale ( VAS ) , subjects took a randomized single dose of either the 2.5 mg nicotine film or the 2 mg nicotine lozenge .
METHODS	Craving assessments were completed at 50s , 3min , 5min , 7min , 15min , 20min , 25min and 30min after drug administration .
RESULTS	Both treatments reduced cue-induced craving and had similar maximum effects on craving relief .
RESULTS	However , the 2.5 mg nicotine film relieved cue-induced craving to a greater degree than the 2 mg nicotine lozenge at 50s ( mean difference : -4.9 , p = 0.014 ) , 3min ( mean difference : -6.7 , p = 0.011 ) , and 5min ( mean difference : -5.6 , p = 0.049 ) post-treatment .
CONCLUSIONS	The study confirmed the results from the pilot study .
CONCLUSIONS	The 2.5 mg nicotine film relieved cue-provoked craving much quicker than the 2 mg nicotine lozenge while both having similar maximum effects .
CONCLUSIONS	Nicotine film could be useful to provide quick craving relief for low dependence smokers .

###25538270
BACKGROUND	Pneumococcal vaccination is recommended for human immunodeficiency virus-infected ( HIV + ) persons ; the best timing for immunization with respect to initiation of antiretroviral therapy ( ART ) is unknown .
METHODS	Double-blind , placebo-controlled trial in HIV + with CD4 ( + ) T cells/L ( CD4 ) 200 randomized to receive the 23-valent pneumococcal polysaccharide vaccine ( PPV23 ) or placebo at enrollment , followed by placebo or PPV23 , respectively , 9-12 months later ( after 6 months of ART ) .
METHODS	Capsular polysaccharide-specific immunoglobin ( Ig ) G and IgM levels to serotypes 1 , 3 , 4 , 6B , and 23F , and opsonophagocytic killing activity ( OPA ) to serotypes 6B and 23F were evaluated 1 month postvaccination .
RESULTS	One hundred seven subjects were enrolled , 72 ( 67.3 % ) were evaluable ( 36/group ) .
RESULTS	Both groups had significant increases in pre - to 1-month postvaccination IgG levels , but negligible to IgM , and significant increases in OPA titers to serotype 6B but not to 23F .
RESULTS	There were no significant differences between groups in serotype-specific IgM or IgG levels or OPA titers .
RESULTS	For the combined groups , there was a significant correlation between serotype-specific IgG and OPA titers to 23F but not to 6B .
RESULTS	There was no correlation between CD4 , viral load and IgG responses .
CONCLUSIONS	In HIV + with CD4 200 , delaying PPV23 until 6 months of ART does not improve responses and may lead to missed opportunities for immunization .

###24967383
BACKGROUND	The aim of this study was to explore the learning effect of engaging trainees by assessing peer performance during simulation-based training .
METHODS	Eighty-four final year medical students participated in the study .
METHODS	The intervention involved trainees assessing peer performance during training .
METHODS	Outcome measures were in-training performance and performance , both of which were measured two weeks after the course .
METHODS	Trainees ' performances were videotaped and assessed by two expert raters using a checklist that included a global rating .
METHODS	Trainees ' satisfaction with the training was also evaluated .
RESULTS	The intervention group obtained a significantly higher overall in-training performance score than the control group : mean checklist score 20.87 ( SD 2.51 ) versus 19.14 ( SD 2.65 ) P = 0.003 and mean global rating 3.25 SD ( 0.99 ) versus 2.95 ( SD 1.09 ) P = 0.014 .
RESULTS	Postcourse performance did not show any significant difference between the two groups .
RESULTS	Trainees who assessed peer performance were more satisfied with the training than those who did not : mean 6.36 ( SD 1.00 ) versus 5.74 ( SD 1.33 ) P = 0.025 .
CONCLUSIONS	Engaging trainees in the assessment of peer performance had an immediate effect on in-training performance , but not on the learning outcome measured two weeks later .
CONCLUSIONS	Trainees had a positive attitude towards the training format .

###25283070
BACKGROUND	Balance training has been demonstrated to improve postural control in patients with Parkinson 's disease ( PD ) .
BACKGROUND	The objective of this pilot randomized clinical trial was to investigate whether a balance training program using augmented visual feedback is feasible , safe , and more effective than conventional balance training in improving postural control in patients with PD .
METHODS	Thirty-three patients with idiopathic PD participated in a five-week training program consisting of ten group treatment sessions of 60min .
METHODS	Participants were randomly allocated to ( 1 ) an experimental group who trained on workstations consisting of interactive balance games with explicit augmented visual feedback ( VFT ) , or ( 2 ) a control group receiving conventional training .
METHODS	Standing balance , gait , and health status were assessed at entry , at six weeks , and at twelve weeks follow-up .
RESULTS	Sixteen patients were allocated to the control group and seventeen to the experimental group .
RESULTS	The program was feasible to apply and took place without adverse events .
RESULTS	Change scores for all balance measures favored VFT , but the change in the primary outcome measure , i.e. the Functional Reach test , did not differ between groups ( t ( 28 ) = -0.116 , p = .908 ) .
RESULTS	No other differences between groups were statistically significant .
CONCLUSIONS	VFT proved to be a feasible and safe approach to balance therapy for patients with PD .
CONCLUSIONS	In this proof-of-concept study VFT was not superior over conventional balance training although observed trends mostly favored VFT .
CONCLUSIONS	These trends approached clinical relevance only in few cases : increasing the training load and further optimization of VFT may strengthen this effect .
BACKGROUND	Controlled Trials , ISRCTN47046299 .

###24720273
OBJECTIVE	To determine whether the use of ultrasound can reduce the incidence of incorrect diagnosis of the fetal head position at instrumental delivery and subsequent morbidity .
METHODS	Two-arm , parallel , randomised trial , conducted from June 2011 to December 2012 .
METHODS	Two maternity hospitals in the Republic of Ireland .
METHODS	A cohort of 514 nulliparous women at term ( 37 weeks of gestation ) with singleton cephalic pregnancies , aiming to deliver vaginally , were recruited prior to an induction of labour or in early labour .
METHODS	If instrumental delivery was required , women who had provided written consent were randomised to receive clinical assessment ( standard care ) or ultrasound scan and clinical assessment ( ultrasound ) .
METHODS	[ Correction added on 17 April 2014 , after first online publication : Sentence was amended . ]
METHODS	Incorrect diagnosis of the fetal head position .
RESULTS	The incidence of incorrect diagnosis was significantly lower in the ultrasound group than the standard care group ( 4/257 , 1.6 % , versus 52/257 , 20.2 % ; odds ratio 0.06 ; 95 % confidence interval 0.02-0 .19 ; P < 0.001 ) .
RESULTS	The decision to delivery interval was similar in both groups ( ultrasound mean 13.8 minutes , SD 8.7 minutes , versus standard care mean 14.6 minutes , SD 10.1 minutes , P = 0.35 ) .
RESULTS	The incidence of maternal and neonatal complications , failed instrumental delivery , and caesarean section was not significantly different between the two groups .
CONCLUSIONS	An ultrasound assessment prior to instrumental delivery reduced the incidence of incorrect diagnosis of the fetal head position without delaying delivery , but did not prevent morbidity .
CONCLUSIONS	A more integrated clinical skills-based approach is likely to be required to prevent adverse outcomes at instrumental delivery .

###24954936
OBJECTIVE	To compare performance and preferences of students who were randomly allocated to classroom or online sections of an elective course on immunization .
METHODS	Students were randomly assigned to either the classroom or online section .
METHODS	All course activities ( lectures , quizzes , case discussions , vaccine administration , and final examination ) were the same for both sections , except for the delivery of lecture material .
RESULTS	Students were surveyed on their preferences at the beginning and end of the semester .
RESULTS	At the end of the semester , the majority of students in the classroom group preferred classroom or blended delivery while the majority of students in the online group preferred blended or online delivery ( p < 0.01 ) .
RESULTS	Student performance was compared at the end of the semester .
RESULTS	There was no significant difference for any of the grades in the course between the 2 sections .
CONCLUSIONS	There was no difference in student performance between the classroom and online sections , suggesting that online delivery is an effective way to teach students about immunization .

###24560135
OBJECTIVE	Assess insulin sensitivity after treatment with a selective PPAR-alpha agonist compared to an HMG CoA reductase inhibitor in human subjects with type 2 diabetes mellitus .
METHODS	Thirteen subjects with Type 2 diabetes mellitus were studied in a double-blind crossover design with 4-week placebo run-in and washout and 12-week treatment periods , randomised to micronised fenofibrate 267 mg or atorvastatin 10mg daily followed by the alternate drug in the second period .
METHODS	Insulin resistance was measured using the isoglycaemic hyperinsulinaemic clamp method with isotope dilution .
RESULTS	Weight , physical activity and other medications did not change .
RESULTS	Total cholesterol ( mean + / - standard error ) was 4.60 + / -0.21 versus 3.9 + / -0.22 mmol/L after fenofibrate and atorvastatin respectively , p < 0.05 .
RESULTS	LDL was 2.70 + / -0.19 versus 1.95 + / -0.23 mmol/L , p < 0.05 and triglyceride 1.64 + / -0.23 versus 1.84 + / -0.26 mmol/L , p < 0.05 .
RESULTS	Insulin-stimulated whole-body glucose disposal ( 35.4 + / -3.1 versus 33.2 + / -3.0 mol/kg/min ) and nadir endogenous glucose production ( 6.2 + / -1.4 versus 7.0 + / -1.1 mol/kg/min ) revealed no significant differences in effects of the treatments .
CONCLUSIONS	In human subjects with Type 2 diabetes mellitus there were characteristic differences in lipid profile changes but no difference in insulin sensitivity after treatment with micronised fenofibrate compared to atorvastatin .
CONCLUSIONS	This study finds no evidence of increased insulin sensitivity using this selective PPAR-alpha agonist over a commonly used statin at these doses .

###24232442
BACKGROUND	Decision-making involves two fundamental axes of control namely valence , spanning reward and punishment , and action , spanning invigoration and inhibition .
BACKGROUND	We recently exploited a go/no-go task whose contingencies explicitly decouple valence and action to show that these axes are inextricably coupled during learning .
BACKGROUND	This results in a disadvantage in learning to go to avoid punishment and in learning to no-go to obtain a reward .
BACKGROUND	The neuromodulators dopamine and serotonin are likely to play a role in these asymmetries : Dopamine signals anticipation of future rewards and is also involved in an invigoration of motor responses leading to reward , but it also arbitrates between different forms of control .
BACKGROUND	Conversely , serotonin is implicated in motor inhibition and punishment processing .
OBJECTIVE	To investigate the role of dopamine and serotonin in the interaction between action and valence during learning.Methods We combined computational modeling with pharmacological manipulation in 90 healthy human volunteers , using levodopa and citalopram to affect dopamine and serotonin , respectively .
RESULTS	We found that , after administration of levodopa , action learning was less affected by outcome valence when compared with the placebo and citalopram groups .
RESULTS	This highlights in this context a predominant effect of levodopa in controlling the balance between different forms of control.Citalopram had distinct effects , increasing participants ` tendency to perform active responses independent of outcome valence , consistent with a role in decreasing motor inhibition .
CONCLUSIONS	Our findings highlight the rich complexities of the roles played by dopamine and serotonin during instrumental learning .

###24602973
BACKGROUND	The clinical benefits associated with the use of the bispectral index ( BIS ) to monitor the depth of sedation during flexible fiberoptic bronchoscopy ( FFB ) are questionable .
OBJECTIVE	To evaluate the added value in terms of procedural safety and patients ' awareness of monitoring sedation depth using the BIS compared to conventional clinical judgment alone in patients undergoing FFB under propofol sedation .
METHODS	The cohort included 81 patients undergoing diagnostic or therapeutic bronchoscopy under propofol sedation that were prospectively randomized to guide the depth of sedation by BIS monitoring ( BIS group ; n = 40 ) or conventional monitoring ( control group ; n = 41 ) .
RESULTS	The mean durations of the procedure were 18 and 19 min in the BIS and control groups , respectively .
RESULTS	No significant difference was noted in the dosage of propofol used between the BIS and control groups ( 168.7 vs. 167.3 mg , respectively ) .
RESULTS	Average sedation-related oxygen saturation drop and transcutaneous CO2 rise were not significantly different between groups .
RESULTS	There was also no significant difference in the percentage of patients that required either hemodynamic support ( 5 vs. 7.5 % , respectively ) , oxygen supplementation by 100 % O2 mask ( 67.5 vs. 82.5 % , respectively ) or Ambu face mask manual ventilation ( 2.5 vs. 5 % , respectively ) between the groups .
RESULTS	No significant difference was noted in terms of patients ' awareness during the procedure , which was assessed following recovery by a structured Brice interview .
CONCLUSIONS	Using BIS to guide the depth of sedation during propofol sedation in patients undergoing FFB of relatively short duration offers no clinically significant advantages over conventional monitoring .

###25158949
OBJECTIVE	The goal of this work was to compare the demineralization of enamel associated with two different self-etching primers and traditional acid etching .
METHODS	A total of 15 volunteers ( 23-32 years , 8 male and 7 female ) were provided with a removable archwire/resin appliance to be worn 20 h/day for 28 days .
METHODS	The device was attached to the mandibular posterior teeth and included samples of human enamel ( from extracted third molars ) located in both posterior vestibules .
METHODS	Both sides featured the same distribution of samples , including one untreated control sample ( group A ) and three samples with brackets ( Victory APC II ) bonded to their surface after conditioning with a self-etching non-fluoride primer ( iBond Gluma Inside ; group B ) , a self-etching fluoride-releasing primer ( Transbond Plus ; group C ) , or traditional acid-etching with 35 % phosphoric acid and Transbond XT ( group D ) .
METHODS	Mineral loss was assessed extraorally under standardized conditions using quantitative light-induced fluorescence ( QLF ) with a specialized camera system ( Inspektor Pro ) .
METHODS	Results were expressed as relative fluorescence loss ( F in % ) .
METHODS	A baseline measurement ( T0 ) was taken before the appliance was first inserted but with the brackets already bonded .
METHODS	Fluorescence loss was analyzed after 3 ( T1 ) , 7 ( T2 ) , 14 ( T3 ) , and 28 days ( T4 ) and compared to the baseline loss ( T0 ) for each of the four study groups ( A to D ) .
METHODS	Kruskal-Wallis and Mann-Whitney U tests were used to compare the results for statistical significance .
RESULTS	The lowest percentages of fluorescence loss both at baseline and during the follow-up assessments was found in group C.
RESULTS	While all three experimental groups ( B , C , D ) presented total decreases in fluorescence loss after 28 days , indicating remineralization , the decrease in group C was the largest .
RESULTS	The Kruskal-Wallis test yielded no significant differences between the three groups other than a significantly lower percentage of fluorescence loss in group C than in group D during the last assessment ( T4 ) .
RESULTS	The untreated samples of control enamel ( group A ) revealed increasing percentages of fluorescence loss over the entire study period .
CONCLUSIONS	Use of the self-etching primers ( groups B and C ) was not associated with patterns of enamel demineralization different from those noted after traditional etching with phosphoric acid ( group D ) .
CONCLUSIONS	The only significant difference we observed was between the self-etching fluoride-releasing primer ( group C ) and traditional etching ( group D ) at the final assessment ( T4 ) .
CONCLUSIONS	Thus , the fluoride-releasing system Transbond Plus was advantageous .

###26343102
BACKGROUND	Musicians are frequently affected by playing-related musculoskeletal disorders ( PRMD ) .
BACKGROUND	Common solutions used by Western medicine to treat musculoskeletal pain include rehabilitation programs and drugs , but their results are sometimes disappointing .
OBJECTIVE	To study the effects of self-administered exercises based on Tuina techniques on the pain intensity caused by PRMD of professional orchestra musicians , using numeric visual scale ( NVS ) .
METHODS	We performed a prospective , controlled , single-blinded , randomized study with musicians suffering from PRMD .
METHODS	Participating musicians were randomly distributed into the experimental ( n = 39 ) and the control ( n = 30 ) groups .
METHODS	After an individual diagnostic assessment , specific Tuina self-administered exercises were developed and taught to the participants .
METHODS	Musicians were instructed to repeat the exercises every day for 3 weeks .
METHODS	Pain intensity was measured by NVS before the intervention and after 1 , 3 , 5 , 10 , 15 and 20 d of treatment .
METHODS	The procedure was the same for the control group , however the Tuina exercises were executed in points away from the commonly-used acupuncture points .
RESULTS	In the treatment group , but not the control group , pain intensity was significantly reduced on days 1 , 3 , 5 , 10 , 15 and 20 .
CONCLUSIONS	The results obtained are consistent with the hypothesis that self-administered exercises based on Tuina techniques could help professional musicians controlling the pain caused by PRMD .
CONCLUSIONS	Although our results are very promising , further studies are needed employing a larger sample size and double blinding designs .

###24341531
BACKGROUND	Peripheral arterial disease ( PAD ) of the lower limbs is a cardiovascular disease highly prevalent particularly in the asymptomatic form .
BACKGROUND	Its prevalence starts to be a concern in low coronary risk countries like Spain .
BACKGROUND	Few studies have analyzed the relationship between ankle-brachial index ( ABI ) and cardiovascular morbi-mortality in low cardiovascular risk countries like Spain where we observe significant low incidence of ischemic heart diseases together with high prevalence of cardiovascular risk factors .
BACKGROUND	The objective of this study is to determine the relationship between pathological ABI and incidence of cardiovascular events ( coronary disease , cerebrovascular disease , symptomatic aneurism of abdominal aorta , vascular surgery ) and death in the > 49year population-based cohort in Spain ( ARTPER ) .
METHODS	Baseline ABI was measured in 3,786 randomly selected patients from 28 Primary Health Centers in Barcelona , distributed as : ABI < 0.9 peripheral arterial disease ( PAD ) , ABI 1.4 arterial calcification ( AC ) , ABI 0.9-1 .4 healthy ; and followed during 4years .
RESULTS	3,307 subjects were included after excluding those with previous vascular events .
RESULTS	Subjects with abnormal ABI were older with higher proportion of men , smokers and diabetics .
RESULTS	260 people presented cardiovascular events ( incidence 2,117 / 100,000 person-years ) and 124 died from any cause ( incidence 978/100 ,000 person-years ) .
RESULTS	PAD had two-fold greater risk of coronary disease ( adjusted hazard ratio ( HR ) = 2.0 , 95 % confidence interval ( CI ) 1.3-3 .2 ) and increased risk of vascular surgery ( HR = 5.6 , 95 % CI 2.8-11 .5 ) and mortality ( HR = 1.8 , 95 % CI 1.4-2 .5 ) .
RESULTS	AC increased twice risk of cerebrovascular events ( HR = 1.9 , 95 % CI 1.0-3 .5 ) with no relationship with ischemic heart disease .
CONCLUSIONS	PAD increases coronary disease risk and AC cerebrovascular disease risk in low cardiovascular risk Mediterranean population .
CONCLUSIONS	ABI could be a useful tool to detect patients at risk in Primary Health Care .

###24474097
BACKGROUND	Peeling is a procedure which aims to accelerate the process of skin exfoliation .
OBJECTIVE	Development of formulations containing lactic acid at 85 % or glycolic acid at 70 % and the evaluation of these formulations on clinical efficacy in reduction of fine wrinkles .
METHODS	Preliminary stability tests were carried out and an in vivo study was performed with three groups with 9 representatives each .
METHODS	One was the control group , which used only sunscreen ; another one used lactic acid + sunscreen , and the last group used acid glycolic + sunscreen .
METHODS	Clinical efficacy was assessed with a CCD color microscope , through the digitization of images before and after treatment .
METHODS	The applications were carried out by a dermatologist , once a mont h every 30 days , during 3 months .
METHODS	The area with wrinkles was calculated by planimetry point counting , in accordance with Mandarin-de-Lacerda .
RESULTS	The formulations were stable in the visual and Ph evaluation .
RESULTS	There was no improvement in the control group ; for lactic acid , there was significant improvement after the second peeling application on the outer lateral area of the right eye and after the third application on the outer lateral area of the left eye .
RESULTS	For the glycolic acid group , there was significant improvement in the outer lateral area of the left eye after the first application , and of the right eye region , after three applications .
RESULTS	The formulations used must be kept under refrigeration and should be manipulated every 30 days .
CONCLUSIONS	Both peelings were effective in reducing fine wrinkles of the outer lateral eye area after three applications ( p 0.05 % ) .
CONCLUSIONS	It was observed that peeling efficacy in the external-lateral region of one eye might be different compared with that in skin of the external-lateral region of the other eye , relative to the speed of skin improvement .

###25078929
BACKGROUND	The Ponseti method of congenital idiopathic clubfoot correction has traditionally specified plaster of Paris ( POP ) as the cast material of choice ; however , there are negative aspects to using POP .
BACKGROUND	We sought to determine the influence of cast material ( POP v. semirigid fibreglass [ SRF ] ) on clubfoot correction using the Ponseti method .
METHODS	Patients were randomized to POP or SRF before undergoing the Ponseti method .
METHODS	The primary outcome measure was the number of casts required for clubfoot correction .
METHODS	Secondary outcome measures included the number of casts by severity , ease of cast removal , need for Achilles tenotomy , brace compliance , deformity relapse , need for repeat casting and need for ancillary surgical procedures .
RESULTS	We enrolled 30 patients : 12 randomized to POP and 18 to SRF .
RESULTS	There was no difference in the number of casts required for clubfoot correction between the groups ( p = 0.13 ) .
RESULTS	According to parents , removal of POP was more difficult ( p < 0.001 ) , more time consuming ( p < 0.001 ) and required more than 1 method ( p < 0.001 ) .
RESULTS	At a final follow-up of 30.8 months , the mean times to deformity relapse requiring repeat casting , surgery or both were 18.7 and 16.4 months for the SRF and POP groups , respectively .
CONCLUSIONS	There was no significant difference in the number of casts required for correction of clubfoot between the 2 materials , but SRF resulted in a more favourable parental experience , which can not be ignored as it may have a positive impact on psychological well-being despite the increased cost associated .

###24831401
OBJECTIVE	To evaluate whether the acute pain experienced during in-hospital recovery from thoracotomy can be effectively reduced by the use of intraoperative measures ( dissection of the neurovascular bundle prior to the positioning of the Finochietto retractor and preservation of the intercostal nerve during closure ) .
METHODS	We selected 40 patients who were candidates for elective thoracotomy in the Thoracic Surgery Department of the Federal University of So Paulo/Paulista School of Medicine , in the city of So Paulo , Brazil .
METHODS	The patients were randomized into two groups : conventional thoracotomy ( CT , n = 20 ) and neurovascular bundle preservation ( NBP , n = 20 ) .
METHODS	All of the patients underwent thoracic epidural anesthesia and muscle-sparing thoracotomy .
METHODS	Pain intensity was assessed with a visual analog scale on postoperative days 1 , 3 , and 5 , as well as by monitoring patient requests for/consumption of analgesics .
RESULTS	On postoperative day 5 , the self-reported pain intensity was significantly lower in the NBP group than in the CT group ( visual analog scale score , 1.50 vs. 3.29 ; p = 0.04 ) .
RESULTS	No significant differences were found between the groups regarding the number of requests for/consumption of analgesics .
CONCLUSIONS	In patients undergoing thoracotomy , protecting the neurovascular bundle prior to positioning the retractor and preserving the intercostal nerve during closure can minimize pain during in-hospital recovery .

###24958795
OBJECTIVE	Developmental assessment is a core paediatric competency , but research demonstrates teaching gaps .
OBJECTIVE	This single-blinded , randomised controlled study compares three teaching approaches to developmental assessment in a large group setting based on a student 's self-perception and objective competency assessment .
METHODS	Students were randomised into one of the following : a didactic lecture followed by self-study with online resources ( control group ) , a didactic lecture and small group tutorial ( small group ) a combined didactic lecture and interactive component using audio-visual equipment ( Interactive Developmental Teaching-IDT group ) .
METHODS	Competency scores ( based on the Royal College of Paediatrics and Child Health ( RCPCH ) scoring system , adapted for undergraduates ) , mean scores of self-reported confidence and degree of motivation were compared between groups .
RESULTS	114 students participated .
RESULTS	Statistically significant difference between mean assessment scores was demonstrated for the small group ( 38.0 ; 95 % CI 36.5 to 39.6 ) and the IDT group ( 37.9 ; 95 % CI 36.5 to 39.4 ) compared to the control group ( 34.8 ; 95 % CI 33.2 to 36.4 ) .
RESULTS	Students ' self-reported confidence , acquisition of knowledge and degree of motivation to practice was higher in IDT and small groups compared to the didactically taught control group .
RESULTS	Teaching costs , if measured by trainer 's time , were one-fifth in the IDT group compared to the small group teaching .
CONCLUSIONS	The IDT is an effective teaching method in large groups , improves competencies compared to didactic lecturing , and is as effective as small group teaching .
CONCLUSIONS	Adoption of the IDT appears to facilitate learning and can be easily delivered with falling ratios of teachers to students .

###25132201
BACKGROUND	Patients undergoing orthognathic surgery are at high risk of developing emergence agitation .
BACKGROUND	We hypothesised that a single-dose of dexmedetomidine would reduce emergence agitation in adults with nasotracheal intubation after orthognathic surgery .
METHODS	Seventy adults ( 20-45 years old ) undergoing orthognathic surgery were randomly assigned to two groups .
METHODS	Patients received intravenous dexmedetomidine 1g/kg ( dex group ) or normal saline ( control group ) for 10min at the end of surgery .
METHODS	Remifentanil was infused at 0.02 g/kg/min during emergence in both groups .
METHODS	The severity of emergence agitation was assessed with the Richmond agitation-sedation scale .
METHODS	Cough , haemodynamic and respiratory profiles , pain , and time to eye opening were evaluated .
RESULTS	The incidence of emergence agitation was not different between dex group and control group ( 38 % vs. 47 % , P = 0.45 ) .
RESULTS	However , severe cough during emergence was reduced in the dex group ( P = 0.04 ) .
RESULTS	Tachycardia during emergence and recovery phases was attenuated in the dex group .
RESULTS	The verbal numeric rating of pain was lower in the dex group .
RESULTS	There were no differences in respiratory rate between the two groups .
RESULTS	Time to eye opening was prolonged in the dex group .
CONCLUSIONS	The addition of a single dose of dexmedetomidine ( 1g/kg ) to low-dose remifentanil infusion did not attenuate emergence agitation in intubated patients after orthognathic surgery compared with low-dose remifentanil infusion alone .
CONCLUSIONS	However , single-dose dexmedetomidine suppressed coughing , haemodynamic changes , and pain during emergence and recovery phases , without respiratory depression .
CONCLUSIONS	Delayed awakening might be associated with this treatment .

###25201934
OBJECTIVE	The purpose of this study was to investigate the effects of a cognitive behavioral therapy-oriented anger management and stress control program on smokers ' quit rates .
METHODS	Of 2348 smokers , 350 were randomly allocated into study and control groups ( n = 175 each ) .
METHODS	An individualized therapy cessation technique was selected for each participant ( combination of behavioral counseling , nicotine replacement therapy , and/or pharmacotherapy ) .
METHODS	The participants in the control group attended a standard quit program , whereas the study group also received an additional 5-session ( 90 minutes each ) cognitive behavioral therapy-oriented program aimed at improving their anger and stress coping skills .
METHODS	At the beginning of the study , both groups were asked to complete the Trait Anger Scale ( TAS ) of the State and Trait Anger Scale and the Self-Confident ( SCS ) and Hopeless ( HS ) subscales of the Stress Coping Styles Inventory ; pretest smoking status of both groups and their coping skills were compared with each other as soon as the program ended ( post-test results ) and after 3 and 6 months ( first and second follow-up tests ) .
RESULTS	Although there was no difference between pretest scores on the TAS ( P = .234 ) , SCS ( P = .130 ) , and HS ( P = .148 ) subscales , post-test results indicate that the study groups ' TAS and HS scores decreased and SCS scores increased ( P < .001 ) , whereas there was no change in the control group ( P > .05 ) .
RESULTS	The study group had a better quit level after 6 months compared with the control group ( 44 % vs 27.4 % ; P < .001 ) .
RESULTS	The anger management and stress control program was found to have a significant effect on cessation ( odds ratio , 2.09 ; 95 % confidence interval , 1.14-3 .85 ) .
CONCLUSIONS	The anger and stress coping skills program may increase the success of quitting smoking .

###25599187
BACKGROUND	Different kinds of gums from various sources enjoy an extremely broad range of commercial and industrial use , from food and pharmaceuticals to printing and adhesives .
BACKGROUND	Although generally recognized as safe by the US Food and Drug Administration ( FDA ) , gums have a history of association with sensitive or allergic reactions .
BACKGROUND	In addition , studies have shown that gums have a structural , molecular similarity to a number of common foods .
BACKGROUND	A possibility exists for cross-reactivity .
OBJECTIVE	Due to the widespread use of gums in almost every aspect of modern life , the overall goal of the current investigation was to determine the degree of immune reactivity to various gum antigens in the sera of individuals representing the general population .
METHODS	The study was a randomized , controlled trial .
METHODS	288 sera purchased from a commercial source .
METHODS	The sera was screened for immunoglobulin G ( IgG ) and immunoglobulin E ( IgE ) antibodies against extracts of mastic gum , carrageenan , xantham gum , guar gum , gum tragacanth , locust bean gum , and - glucan , using indirect enzyme-linked immunosorbent assay ( ELISA ) testing .
METHODS	For each gum antigen , inhibition testing was performed on the 4 sera that showed the highest IgG and IgE immune reactivity against the different gums used in the study .
METHODS	Inhibition testing on these same sera for sesame albumin , lentil , corn , rice , pineapple , peanut , pea protein , shrimp , or kidney bean was used to determine the cross-reactivity of these foods with the gum .
RESULTS	Of the 288 samples , 4.2 % -27 % of the specimens showed a significant elevation in IgG antibodies against various gums .
RESULTS	Only 4 of 288 , or 1.4 % , showed a simultaneous elevation of the IgG antibody against all 7 gum extracts .
RESULTS	For the IgE antibody , 15.6 % -29.1 % of the specimens showed an elevation against the various gums .
RESULTS	A significant percentage of the specimens , 12.8 % , simultaneously produced IgE antibodies against all 7 tested extracts .
CONCLUSIONS	Overall , the percentage of elevation in IgE antibodies against different gum extracts , with the exception of carrageenan , was much higher than for the IgG antibody .
CONCLUSIONS	The results of the current study showed that a subgroup of healthy individuals who produced not only IgG but also IgE antibodies against various gums may suffer from hidden food immune reactivities and sensitivities .
CONCLUSIONS	Further study is needed to examine the clinical importance of gums and cross-reactive food antibodies in symptomatic individuals .

###24506965
OBJECTIVE	To investigate the effect of low-dose carvedilol combined with candesartan in the prevention of acute and chronic cardiotoxicity of anthracycline drugs in adjuvant chemotherapy of breast cancer .
METHODS	Forty patients were randomly divided into two groups : the experimental group with chemotherapy plus low-dose carvedilol combined with candesartan ( 20 cases ) and control group with chemotherapy alone ( 20 cases ) .
METHODS	The same chemotherapy was given to the two groups .
METHODS	All the 40 patients had no contraindication for carvedilol and candesartan .
METHODS	Patients of the experimental group received low-dose carvedilol from 2.5 mg orally twice a day at first cycle to 5 mg twice a day gradually if no side reactions , and candesartan 2.5 mg orally once a day .
METHODS	Electrocardiogram , ultrasonic cardiogram , arrhythmia , troponin and non-hematologic toxicity were recorded and compared after the second , forth and sixth cycle of chemotherapy .
METHODS	Each cycle included 21 days .
RESULTS	LVEF was decreased along with the prolongation of chemotherapy in the experimental group and control group .
RESULTS	LVEDD and LVESD showed no significant changes in the experimental group , but gradually increased in the control group .
RESULTS	After four and six cycles of chemotherapy , LVEF were ( 57.00 5.13 ) % and ( 45.95 3.68 ) % , respectively , in the control group , significantly lower than that of ( 67.00 5.13 ) % and ( 57.50 2.57 ) % , respectively , in the experimental group ( P < 0.05 ) .
RESULTS	After six cycles of chemotherapy , LVEDD and LVESD were ( 50.00 10.48 ) mm and ( 35.01 2.99 ) mm , respectively , in the control group , significantly higher than those before chemotherapy ( P < 0.05 ) and experimental group ( P < 0.001 ) .
RESULTS	The rate of ST segment and T wave abnormalities was 80.0 % in the control group after six cycles of chemotherapy , significantly higher than that of 25.0 % after four cycles of chemotherapy ( P = 0.001 ) and 10.0 % after two cycles of chemotherapy ( P < 0.001 ) .
RESULTS	The reduction of QRS voltage , arrhythmia and abnormal troponin were 55.0 % , 45.0 % and 45.0 % , respectively , in the control group , significantly higher than those in the experimental group ( 20.0 % , P < 0.05 ) , ( 10.0 % , P = 0.010 ) and ( 10.0 % , P < 0.05 ) , respectively .
RESULTS	The rate of abnormal expression of troponin was 45.0 % in the control group , significantly higher than the 10.0 % in the experimental group ( P < 0.05 ) .
CONCLUSIONS	The use of low-dose carvedilol combined with candesartan can reduce the acute and chronic cardiotoxicity of anthracycline drugs , and with tolerable toxicities .
CONCLUSIONS	This may provide a new approach to prevent cardiotoxicity of anthracycline drugs in adjuvant chemotherapy of breast cancer .

###25775881
OBJECTIVE	To compare the image quality at coronary multidetector computed tomography ( MDCT ) using low-dose and low-iodine protocol study in comparison with the standard protocol .
METHODS	In study included 60 patients undergoing coronary computed tomography angiography .
METHODS	All examinations were performed with 64-row MDCT using prospective ECG-gating and ASIR 40 % .
METHODS	30 patients were examined using a low-concentration ( Iodixanol , 270 mg I/ml ) iodinated contrast medium and low tube voltage ( 80 kV ) ( group 1 ) , 30 patients -- using of high-concentration ( Iodixanol , 320 mg I/ml ) iodinated contrast medium and standard tube voltage ( 120 kV ) ( group 2 ) .
METHODS	Image quality of coronary arteries was evaluated using a four-point grading scale , images were randomised .
METHODS	Intra-arterial density was measured for the proximal and distal segments of left anterior descending artery ( LAD ) and right coronary artery ( RCA ) .
RESULTS	Age , heart rate , BMI and scan parameters were not statistically different between the two groups .
RESULTS	Analysis of coronaries visualization revealed the same image quality for group 1 and group 2 ( image quality scores were 1.28 0.28 vs. 1.34 0.29 , p = 0.4 ) .
RESULTS	There was no significant difference between mean enhancement values in the distal segments of RCA and LAD for the two groups .
RESULTS	Intraarterial density for proximal LAD and proximal RCA for the nazpyara , umepamuenas group 2 were significantly lower ( p < 0.05 ) than those values for the group 1 .
RESULTS	Conclusion .
RESULTS	Theuse of low-dose and low-iodine protocol can be beneficial for patient safety and or image quality ithout loss of diag - stic information .

###25528621
BACKGROUND	Intertrochanteric fractures of the femur are prevalent in the elderly , and leave patients with functional restrictions after surgical treatment .
BACKGROUND	The aim of this study was to compare the functional recovery at 1-year follow-up of elderly patients with intertrochanteric fractures treated surgically with the dynamic hip screw ( DHS ) or proximal femoral nail ( PFN ) fixation techniques .
METHODS	This prospective , randomised , blinded trial included patients aged over 65 years with intertrochanteric fractures classified as AO group 31 .
METHODS	A1 or 31 .
METHODS	A2 .
METHODS	The patients were allocated into one of two treatment groups : one treated with DHS and the other with PFN .
METHODS	Data on functional recovery were obtained using the Functional Recovery Score developed by Zuckerman for elderly patients with hip fracture .
METHODS	Variables were described as means and standard deviations , and the non-parametric Kolmogorov-Smirnov test was used to verify the normality of data distribution .
METHODS	Non-normally distributed variables were compared using the non-parametric Friedman and Mann-Whitney U tests .
METHODS	Data processing and analysis were carried out in SPSS 10.0 .
METHODS	Results were deemed significant at the 5 % level ( p 0.05 ) .
RESULTS	There were no significant between-group differences in age ( p = 0.152 ) , sex ( p = 0.363 ) , or American Society of Anaesthesiologists ( ASA ) score ( p = 0.579 ) .
RESULTS	Functional recovery scores in the DHS group at 3 and 6 months after surgery were significantly reduced from preoperative baseline scores ( p = 0.007 ) compared with in the PFN group .
RESULTS	However , there were no statistically significant differences between the two groups in functional recovery scores at baseline ( p = 0.346 ) or at 3 months ( p = 0.880 ) , 6 months ( p = 0.699 ) , and 12 months ( p = 0.468 ) after surgery .
RESULTS	There was no between-group difference in mortality ( p = 0.140 ) .
CONCLUSIONS	At 1-year follow-up , functional recovery scores were similar in elderly patients treated with the DHS and PFN techniques .
CONCLUSIONS	However , DHS-treated patients exhibited significant loss of function in the first 6 months after surgery , which did not occur in the PFN-treated group .

###24256166
BACKGROUND	This is the first randomized , double-blind , placebo-controlled trial ( EUDRACT No. 2009-013923-43 ) evaluating nickel oral hyposensitizing treatment ( NiOHT ) in patients with `` systemic nickel allergy syndrome '' ( SNAS ) , characterized by Ni-allergic contact dermatitis and systemic reactions after eating Ni-rich food .
METHODS	Adults with positive Ni-patch test , who reported symptoms suggesting SNAS , which improved after Ni-poor diet , and were positive to Ni-oral challenge were eligible .
METHODS	Patients were randomly assigned to three treatments ( 1.5 g , 0.3 g , or 30 ng Ni/week ) or placebo for a year , with progressive reintroduction of Ni-rich foods form the 5 ( th ) month .
METHODS	Out of 141 patients randomized , 113 completed the trial .
METHODS	Endpoints were efficacy and tolerability of treatment .
RESULTS	During Ni-rich food re-introduction , the 1.5 g Ni/week group had a mean VAS score significantly higher than placebo ( p = 0.044 ) , with significant improvement of gastrointestinal symptoms ( p = 0.016 ;) and significantly fewer rescue medications .
RESULTS	Cutaneous manifestations also improved but without reaching statistical significance .
RESULTS	After the treatment , oral challenge with higher Ni doses than at baseline were needed to cause symptoms to flare-up in significantly more patients given 1.5 g Ni/week than placebo ( p = 0.05 ) .
RESULTS	Patients reported no side-effects .
CONCLUSIONS	NiOHT is effective in SNAS , in particular on gastrointestinal manifestations , with trend toward improvement of cutaneous symptoms .

###24952581
BACKGROUND	Surgery for subacromial impingement syndrome is often performed in working age and postoperative physiotherapy exercises are widely used to help restore function .
BACKGROUND	A recent Danish study showed that 10 % of a nationwide cohort of patients retired prematurely within two years after surgery .
BACKGROUND	Few studies have compared effects of different postoperative exercise programmes on shoulder function , and no studies have evaluated workplace-oriented interventions to reduce postoperative work disability .
BACKGROUND	This study aims to evaluate the effectiveness of physiotherapy exercises and occupational medical assistance compared with usual care in improving shoulder function and reducing postoperative work disability after arthroscopic subacromial decompression .
METHODS	The study is a mainly pragmatic multicentre randomised controlled trial .
METHODS	The trial is embedded in a cohort study of shoulder patients referred to public departments of orthopaedic surgery in Central Denmark Region .
METHODS	Patients aged 18-63 years , who still have shoulder symptoms 8-12 weeks after surgery , constitute the study population .
METHODS	Around 130 participants are allocated to : 1 ) physiotherapy exercises , 2 ) occupational medical assistance , 3 ) physiotherapy exercises and occupational medical assistance , and 4 ) usual care .
METHODS	Intervention manuals allow individual tailoring .
METHODS	Primary outcome measures include Oxford Shoulder Score and sickness absence due to symptoms from the operated shoulder .
METHODS	Randomisation is computerised with allocation concealment by randomly permuted block sizes .
METHODS	Statistical analyses will primarily be performed according to the intention-to-treat principle .
CONCLUSIONS	The paper presents the rationale , design , methods , and operational aspects of the Shoulder Intervention Project ( SIP ) .
CONCLUSIONS	SIP evaluates a new rehabilitation approach , where physiotherapy and occupational interventions are provided in continuity of surgical episodes of care .
CONCLUSIONS	If successful , the project may serve as a model for rehabilitation of surgical shoulder patients .
BACKGROUND	Current Controlled Trials ISRCTN55768749 .

###24289740
BACKGROUND	The strongest risk factor for depression is having a family history of the condition .
BACKGROUND	Many individuals with a family history of depression are concerned about their personal risk for depression and report unmet educational and psychological support needs .
BACKGROUND	No supportive and/or educational interventions are currently available that target this group of individuals .
BACKGROUND	In this study we will develop and evaluate the first online psycho-educational intervention targeted to individuals with a family history of depression .
BACKGROUND	Genetic risk information and evidence-rated information on preventive strategies for depression will be provided to such individuals in a general practice setting .
BACKGROUND	The intervention will also incorporate a risk assessment tool .
BACKGROUND	The content and delivery of the intervention will be pilot-tested .
METHODS	The proposed intervention will be evaluated in the general practitioner ( GPs ) setting , using a cluster randomized controlled trial .
METHODS	GP practices will be randomized to provide either access to the online , targeted psycho-educational intervention or brief generic information about depression ( control ) to eligible patients .
METHODS	Eligibility criteria include having at least one first-degree relative with either major depressive disorder ( MDD ) or bipolar disorder ( BD ) .
METHODS	The primary outcome measure is ` intention to adopt , or actual adoption of , risk-reducing strategies ' .
METHODS	Secondary outcome measures include : depression symptoms , perceived stigma of depression , knowledge of risk factors for development of depression and risk-reducing strategies , and perceived risk of developing depression or having a recurrence of family history .
METHODS	Over the course of the study , participants will complete online questionnaires at three time points : at baseline , and two weeks and six months after receiving the intervention or control condition .
CONCLUSIONS	This novel psycho-educational intervention will provide individuals with a family history of depression with information on evidence-based strategies for the prevention of depression , thus , we hypothesize , enabling them to make appropriate lifestyle choices and implement behaviors designed to reduce their risk for depression .
CONCLUSIONS	The online psycho-educational intervention will also provide a model for similar interventions aimed at individuals at increased familial risk for other psychiatric disorders .
BACKGROUND	The study is registered with the Australian and New Zealand Clinical Trials Group ( Registration no : ACTRN12613000402741 ) .

###24326529
OBJECTIVE	This study aimed to evaluate cervical lesions by the Swede coloscopy system , histologic finding , liquid-based cytology , and human papillomavirus ( HPV ) in women who resulted positive for visual inspection of the cervix with acetic acid ( VIA ) by using a pocket-sized battery-driven colposcope , the Gynocular ( Gynius AB , Sweden ) .
METHODS	This study was a crossover , randomized clinical trial at the colposcopy clinic of Bangabandhu Sheikh Mujib Medical University in Dhaka , Bangladesh , with 540 VIA-positive women .
METHODS	Swede scores were obtained by the Gynocular and stationary colposcope , as well as samples for liquid-based cytology , HPV , and cervical biopsies .
METHODS	The Swede scores were compared against the histologic diagnosis and used as criterion standard .
METHODS	The percentage agreement and the statistic for the Gynocular and standard colposcope were also calculated .
RESULTS	The Gynocular and stationary colposcope showed high agreement in Swede scores with a statistic of 0.998 , P value of less than 0.0001 , and no difference in detecting cervical lesions in biopsy .
RESULTS	Biopsy detected cervical intraepithelial neoplasia ( CIN ) 2 + ( CIN2 , CIN3 , and invasive cancer ) in 38 ( 7 % ) of the women , whereas liquid-based cytology detected CIN2 + in 13 ( 2.5 % ) of the women .
RESULTS	Forty-four ( 8.6 % ) women who were tested resulted positive for HPV ; 20 ( 3.9 % ) women had HPV-16 , 2 ( 0.4 % ) had HPV-18 , and 22 ( 4.3 % ) had other high-risk HPV .
CONCLUSIONS	Our study showed that few VIA-positive women had CIN2 + lesions or HPV infection .
CONCLUSIONS	Colposcopy by Swede score identified significantly more CIN2 + lesions than liquid-based cytology and could offer a more accurate screening and selection for immediate treatment of cervical lesions in low-resource settings .

###25946280
BACKGROUND	Catheter ablation is less successful for persistent atrial fibrillation than for paroxysmal atrial fibrillation .
BACKGROUND	Guidelines suggest that adjuvant substrate modification in addition to pulmonary-vein isolation is required in persistent atrial fibrillation .
METHODS	We randomly assigned 589 patients with persistent atrial fibrillation in a 1:4:4 ratio to ablation with pulmonary-vein isolation alone ( 67 patients ) , pulmonary-vein isolation plus ablation of electrograms showing complex fractionated activity ( 263 patients ) , or pulmonary-vein isolation plus additional linear ablation across the left atrial roof and mitral valve isthmus ( 259 patients ) .
METHODS	The duration of follow-up was 18 months .
METHODS	The primary end point was freedom from any documented recurrence of atrial fibrillation lasting longer than 30 seconds after a single ablation procedure .
RESULTS	Procedure time was significantly shorter for pulmonary-vein isolation alone than for the other two procedures ( P < 0.001 ) .
RESULTS	After 18 months , 59 % of patients assigned to pulmonary-vein isolation alone were free from recurrent atrial fibrillation , as compared with 49 % of patients assigned to pulmonary-vein isolation plus complex electrogram ablation and 46 % of patients assigned to pulmonary-vein isolation plus linear ablation ( P = 0.15 ) .
RESULTS	There were also no significant differences among the three groups for the secondary end points , including freedom from atrial fibrillation after two ablation procedures and freedom from any atrial arrhythmia .
RESULTS	Complications included tamponade ( three patients ) , stroke or transient ischemic attack ( three patients ) , and atrioesophageal fistula ( one patient ) .
CONCLUSIONS	Among patients with persistent atrial fibrillation , we found no reduction in the rate of recurrent atrial fibrillation when either linear ablation or ablation of complex fractionated electrograms was performed in addition to pulmonary-vein isolation .
CONCLUSIONS	( Funded by St. Jude Medical ; ClinicalTrials.gov number , NCT01203748 . )

###24476106
BACKGROUND	Psychopathology in women after childbirth represents a significant risk factor for parenting and infant mental health .
BACKGROUND	Regarding child development , these infants are at increased risk for developing unfavorable attachment strategies to their mothers and for subsequent behavioral , emotional and cognitive impairments throughout childhood .
BACKGROUND	To date , the specific efficacy of an early attachment-based parenting group intervention under standard clinical outpatient conditions , and the moderators and mediators that promote attachment security in infants of mentally ill mothers , have been poorly evaluated .
METHODS	This randomized controlled clinical trial tests whether promoting attachment security in infancy with the Circle of Security ( COS ) Intervention will result in a higher rate of securely attached children compared to treatment as usual ( TAU ) .
METHODS	Furthermore , we will determine whether the distributions of securely attached children are moderated or mediated by variations in maternal sensitivity , mentalizing , attachment representations , and psychopathology obtained at baseline and at follow-up .
METHODS	We plan to recruit 80 mother-infant dyads when infants are aged 4-9 months with 40 dyads being randomized to each treatment arm .
METHODS	Infants and mothers will be reassessed when the children are 16-18 months of age .
METHODS	Methodological aspects of the study are systematic recruitment and randomization , explicit inclusion and exclusion criteria , research assessors and coders blinded to treatment allocation , advanced statistical analysis , manualized treatment protocols and assessments of treatment adherence and integrity .
CONCLUSIONS	The aim of this clinical trial is to determine whether there are specific effects of an attachment-based intervention that promotes attachment security in infants .
CONCLUSIONS	Additionally , we anticipate being able to utilize data on maternal and child outcome measures to obtain preliminary indications about potential moderators of the intervention and inform hypotheses about which intervention may be most suitable when offered in a clinical psychiatric outpatient context .
BACKGROUND	Current Controlled Trials ISRCTN88988596 .

###24736301
OBJECTIVE	We aimed to investigate , in patients with ST-segment elevation myocardial infarction ( STEMI ) , whether the previously reported clinical benefits of sirolimus-eluting stent ( s ) ( SES ) in terms of reducing a major adverse cardiac and cerebrovascular event ( MACCE ) compared with bare-metal stent ( s ) ( BMS ) were maintained over a 5-year time period .
BACKGROUND	In the prospective single-centre randomized DEBATER trial , SES significantly reduced the rate of MACCE in STEMI patients within 1 year compared with BMS , mainly driven by a reduction of target lesion revascularization .
BACKGROUND	Randomized data on the long-term safety and efficacy of SES in STEMI patients are conflicting and limited .
METHODS	Between January 2006 and May 2008 , a total of 907 STEMI patients were randomized to receive SES or BMS .
METHODS	The primary endpoint was MACCE defined as the composite of death , myocardial infarction , stroke , repeat revascularization and bleeding .
METHODS	Five-year follow-up data were collected by reviewing hospital records , telephone calls and a written questionnaire .
RESULTS	At 5 years , the rate of MACCE between the SES group and the BMS group was no longer significantly different ( 33.3 vs. 39.3 % , P = 0.12 ) .
RESULTS	The cumulative incidence of death and myocardial infarction was similar in both groups ( 11.0 vs. 9.7 % , P = 0.51 ) .
RESULTS	Repeat revascularization was performed in 21.1 and 25.8 % of patients , respectively ( P = 0.12 ) .
RESULTS	The rate of very late stent thrombosis ( 1-5 years of follow-up ) was very low in both groups ( 2.0 vs. 0.7 % , P = 0.12 ) .
CONCLUSIONS	The benefits of SES in STEMI patients in terms of reducing MACCE faded over time .
CONCLUSIONS	We found no safety concerns in terms of SES in the long term , with extremely low rates of very late stent thrombosis .

###24315980
OBJECTIVE	The aims of the study protocol are to investigate different adapted physical training programs in patients with advanced lung cancer undergoing palliative chemo - or radiotherapy and to evaluate their effects on physical performance , quality of life , symptom burden , and efficacy of oncologic treatment .
METHODS	Patients will be randomized into three study arms : interventional group 1 performing aerobic exercise , interventional group 2 performing resistance training , and a control group without specific physical training .
METHODS	Interventional training will be performed for 12 weeks consisting of two supervised and one self-instructed training sessions per week each .
METHODS	Respiratory therapy over 12 weeks is provided in all three study arms as an established supportive therapy in lung cancer patients .
METHODS	Primary efficacy endpoint is physical performance measured by peak oxygen consumption ( VO ( 2 ) peak ) .
METHODS	Secondary efficacy endpoints include additional parameters of physical performance ( resistance , lung function , perceived exertion , level of physical activity and IPAQ-questionnaire ) , health-related quality of life ( EORTC QLQ C30-questionnaire ) , disease and treatment related symptoms ( Memorial Symptom Assessment Scale ) , biologic parameter ( e.g. body composition , blood values of immune system , chronic inflammation , glucose and lipid metabolisms ) , and parameter of efficacy of oncologic treatment .
CONCLUSIONS	The results of this study will offer an overview over possible effects of specific training interventions on health related quality of life , physical and psychological symptoms , and on the efficacy of oncologic treatment .
CONCLUSIONS	The primary aim of this study is to detect adapted intervention programs for metastatic lung cancer undergoing palliative chemotherapy .

###25965782
BACKGROUND	The purpose of the current study was to examine the effect of an oncologist 's exercise recommendation with and without an exercise motivation package on the amount of exercise participation and quality of life ( QOL ) in survivors of breast and colorectal cancer .
METHODS	A total of 162 survivors of early-stage breast and colorectal cancer who completed primary and adjuvant treatments were recruited for the current study .
METHODS	Participants were randomly assigned into 1 of 3 groups : 1 ) control ( 59 patients ) ; 2 ) those receiving an oncologist 's exercise recommendation ( 53 patients ) ; and 3 ) those receiving an oncologist 's exercise recommendation with an exercise motivation package ( 50 patients ) .
METHODS	At baseline and after 4 weeks , the level of exercise participation and QOL were assessed .
RESULTS	Of the 162 participants , 130 ( 80.2 % ) completed the trial .
RESULTS	Intention-to-treat analysis indicated that participants who received an oncologist 's exercise recommendation with an exercise motivation package significantly increased their level of exercise participation in terms of minutes ( 47.57 added minutes per week ; 95 % confidence interval , 9.62-85 .52 minutes [ P = .022 ] vs control ) and in Metabolic Equivalent of Task ( MET ) - hours per week ( 4.14 additional MET-hours per week ; 95 % confidence interval , 1.70-6 .58 MET-hours [ P = .004 ] vs control ) compared with the control group .
RESULTS	Participants who received only their oncologist 's exercise recommendation did not increase their exercise participation level .
RESULTS	Further analysis demonstrated that role functioning was significantly improved among participants who received an oncologist 's exercise recommendation with an exercise motivation package .
CONCLUSIONS	Providing an exercise motivation package in addition to the oncologist 's exercise recommendation to increase the level of exercise among survivors of breast and colorectal cancer should be considered .

###25336055
BACKGROUND	Thoracic epidural analgesia ( TEA ) is recommended for post-operative pain relief in patients undergoing major abdominal surgery via a midline incision .
BACKGROUND	However , the effectiveness of TEA is variable with high failure rates reported post-operatively .
BACKGROUND	Common side effects such as low blood pressure and motor block can reduce mobility and hinder recovery , and a number of rare but serious complications can also occur following their use.Rectus sheath catheters ( RSC ) may provide a novel alternative approach to somatic analgesia without the associated adverse effects of TEA .
BACKGROUND	The aim of this study is to compare the efficacy of both techniques in terms of pain relief , patient experience , post-operative functional recovery , safety and cost-effectiveness .
METHODS	This is a single-centre randomised controlled non-blinded trial , which also includes a nested qualitative study .
METHODS	Over a two-year period , 132 patients undergoing major abdominal surgery via a midline incision will be randomised to receive either TEA or RSC for post-operative analgesia .
METHODS	The primary outcome measures pain scores on moving from a supine to a sitting position at 24 hours post wound closure , and the patient experience between groups evaluated through in-depth interviews .
METHODS	Secondary outcomes include pain scores at rest and on movement at other time points , opiate consumption , functional recovery , morbidity and cost-effectiveness .
CONCLUSIONS	This will be the first randomised controlled trial comparing thoracic epidurals to ultrasound-guided rectus sheath catheters in adults undergoing elective midline laparotomy .
CONCLUSIONS	The standardised care provided by an Enhanced Recovery Programme makes this a comparison between two complex pain packages and not simply two analgesic techniques , in order to ascertain if RSC is a viable alternative to TEA .
BACKGROUND	Current Controlled Trials ISRCTN81223298 ( 16 January 2014 ) .

###24267010
BACKGROUND	Trigeminal neuralgia ( TN ) is a rare severe unilateral facial pain condition .
BACKGROUND	Current guidelines in trigeminal neuralgia management recommend sodium channel blockers -- carbamazepine or oxcarbazepine -- as the first-line treatment .
BACKGROUND	However , the currently available drugs are often associated with poor tolerability resulting in sub-optimal pain control .
BACKGROUND	CNV1014802 is a novel sodium channel blocker that is being assessed in the treatment of trigeminal neuralgia .
BACKGROUND	Due to the severity of the condition , it is not ethical to conduct a traditional placebo-controlled randomized controlled trial .
BACKGROUND	It is also difficult to use an active control such as carbamazepine , the current gold standard , because of its complex pharmacology and potential for drug interactions .
METHODS	The trial uses a randomized withdrawal design to assess efficacy in this rare condition .
METHODS	There is a 21-day open-label phase followed by a randomized 28-day placebo-controlled phase for responders .
METHODS	Thirty patients will be randomized .
METHODS	The primary outcome measure will be pain relief , but secondary measures of quality of life will be of significant importance given the effect of this condition on activities of daily living .
METHODS	Safety and adverse event endpoints are described .
CONCLUSIONS	There have been very few well-controlled , randomized , placebo-controlled studies in trigeminal neuralgia , and the majority of drugs have had other primary uses .
CONCLUSIONS	Due to the severity of the pain , minimizing the time a patient is administered placebo was a key factor in designing this study .
CONCLUSIONS	This study will not only provide data on the efficacy of CNV1014802 in trigeminal neuralgia , but will also provide information on the effectiveness and acceptability of a novel trial design in trigeminal neuralgia .
BACKGROUND	Trial number NCT01540630 .

###25710507
OBJECTIVE	To evaluate the therapeutic effect of UV-A/riboflavin collagen cross-linking ( CXL ) on moderate bacterial corneal ulcers .
METHODS	Thirty-two patients with moderate bacterial keratitis were selected .
METHODS	All patients were treated according to the standard medical treatment protocol .
METHODS	The patients were randomly allocated to 2 groups : case and control groups of 16 patients each using a numerical randomization table .
METHODS	The case group received CXL treatment .
METHODS	In the CLX group , corneal epithelium was removed and 0.1 % riboflavin drops were applied .
METHODS	Then the corneas were irradiated with UV-A ( 365 nm ) with an irradiance of 3 mW/cm for 30 minutes .
METHODS	The grade of ulcers , size of epithelial defects , and area of infiltrates were recorded on days 1 , 7 , and 14 of treatment .
RESULTS	There was no statistically significant difference between the groups 1 day after the treatment .
RESULTS	The mean treatment duration was 17.2 4.1 days in the CXL group and 24.7 5.5 days in the control group .
RESULTS	The epithelial defects were smaller in the CXL group at 7 days ( P = 0.001 ) and 14 days ( P = 0.001 ) after the beginning of treatment .
RESULTS	The area of infiltrates in CXL group was smaller than the control group at both 7 days ( P = 0.001 ) and 14 days ( P < 0.001 ) after the start of treatment .
CONCLUSIONS	Our results support the beneficial effect of CXL in patients with moderate bacterial keratitis .
CONCLUSIONS	In addition to accelerating epithelialization , this method shortens the course of treatment and may minimize or remove the need for surgery or other serious sequelae , such as corneal perforation .

###24521180
OBJECTIVE	Little is known about the ability of community pharmacists who are inexperienced in medication review to identify drug-related problems ( DRPs ) .
OBJECTIVE	The objective of our study was to investigate the completeness of DRPs in terms of number , type and clinical relevance identified by community pharmacists when performing home medication reviews ( HMRs ) .
METHODS	This is a cross-sectional study within the intervention arm of a randomized controlled trial among community-dwelling patients ( 65years , 5 drugs ) in ten Dutch community pharmacies .
METHODS	Community pharmacists , who were inexperienced in medication review , received 2-day training in medication review .
METHODS	These pharmacists interviewed patients at home about their medicines , identified potential DRPs and made recommendations in combination with medication and clinical records .
METHODS	Expert reviewers completed the number of potential DRPs and recommendations by reviewing all available information , including patient interview reports .
CONCLUSIONS	In 155 patients , community pharmacists identified a mean of 36 ( SD 28 ) potential DRPs per patient and expert reviewers added 65 ( SD 32 ) DRPs .
CONCLUSIONS	Community pharmacists formulated 26 ( SD 23 ) recommendations per patient and reviewers added 75 ( SD 33 ) recommendations .
CONCLUSIONS	Community pharmacists identified a higher proportion of clinically relevant DRPs compared with expert reviewers , as assessed by DRPs with high priority [ OR = 18 ( 95 % CI 14-22 ) ] , DRPs associated with recommendations for drug change [ OR = 19 ( 95 % CI 15-23 ) ] and implemented recommendations for drug change [ OR = 21 ( 95 % CI 16-27 ) ] .
CONCLUSIONS	This study shows that the completeness of medication reviews by inexperienced community pharmacists with limited training could be improved , although they identified a higher proportion of potentially clinically relevant DRPs compared with expert reviewers .
CONCLUSIONS	The results suggest that community pharmacists with limited experience in medication review may need more intensive post-graduate training .

###24577065
BACKGROUND	In 2010 , the Danish Government launched the Danish national return-to-work ( RTW ) programme to reduce sickness absence and promote labour market attainment .
BACKGROUND	Multidisciplinary teams delivered the RTW programme , which comprised a coordinated , tailored and multidisciplinary effort ( CTM ) for sickness absence beneficiaries at high risk for exclusion from the labour market .
BACKGROUND	The aim of this article was to evaluate the effectiveness of the RTW programme on self-support .
METHODS	Beneficiaries from three municipalities ( denoted M1 , M2 and M3 ) participated in a randomized controlled trial .
METHODS	We randomly assigned beneficiaries to CTM ( M1 : n = 598 ; M2 : n = 459 ; M3 : n = 331 ) or to ordinary sickness absence management ( OSM ) ( M1 : n = 393 ; M2 : n = 324 ; M3 : n = 95 ) .
METHODS	We used the Cox proportional hazards model to estimate hazard ratios ( HR ) comparing rates of becoming self-supporting between beneficiaries receiving CTM and OSM .
RESULTS	In M2 , beneficiaries from employment receiving CTM became self-supporting faster compared with beneficiaries receiving OSM ( HR = 1.32 , 95 % CI : 1.08-1 .61 ) .
RESULTS	In M3 , beneficiaries receiving CTM became self-supporting slower than beneficiaries receiving OSM ( HR = 0.72 , 95 % CI : 0.54-0 .95 ) .
RESULTS	In M1 , we found no difference between the two groups ( HR = 0.99 , 95 % CI : 0.84-1 .17 ) .
CONCLUSIONS	The effect of the CTM programme on return to self-support differed substantially across the three participating municipalities .
CONCLUSIONS	Thus , generalizing the study results to other Danish municipalities is not warranted .
BACKGROUND	ISRCTN43004323 .

###25627123
BACKGROUND	Treatment of chronic wounds using traditional surgical procedures is challenging because of the low graft take rates .
BACKGROUND	This study investigated the combination approach of split-thickness autografts with harvested skin cell suspension for chronic wound treatment .
METHODS	This randomized clinical trial enrolled patients with chronic wounds between March 2012 and December 2013 .
METHODS	Patients who were assigned randomly to the active treatment received a split-thickness autograft combined with harvested skin cell suspension .
METHODS	Control patients received the split-thickness autograft alone .
METHODS	The primary outcome was the rate of complete wound closure by postoperative day 28 .
METHODS	Analysis was by intention to treat .
METHODS	Patients who achieved wound closure were followed up for a minimum of 6 months to evaluate the quality of healing .
RESULTS	A total of 88 patients were included , 44 in each group .
RESULTS	More patients achieved complete wound closure in the skin cell group than in the control group ( 41 versus 34 patients ; P = 0035 ) .
RESULTS	Complete wound closure was observed at a median of 14 ( 95 per cent c.i. 120 to 160 ) days in the skin cell group and 20 ( 157 to 243 ) days in the control group ( P = 0001 ) .
RESULTS	The skin cell group had significantly fewer complications ( 4 versus 11 patients ; P = 0047 ) .
RESULTS	The autografted sites displayed better physical attributes and a reduced tendency for wound recurrence in the skin cell group .
CONCLUSIONS	Complementary split-thickness autologous skin grafting with autologous skin cells harvested using ReCell ( Avita Medical , Cambridge , UK ) technology improved the healing rate of chronic wounds .
BACKGROUND	UMIN000011966 ( http://www.umin.ac.jp/ctr ) .

###24864125
BACKGROUND	Prior receipt of a trivalent seasonal influenza vaccine ( TIV ) can affect hemagglutination inhibition ( HI ) antibody responses to pandemic influenza vaccines .
BACKGROUND	We investigated the effect of TIV priming on humoral responses to AS03-adjuvanted and nonadjuvanted A ( H1N1 ) pdm09 vaccines , the role of AS03 on cell-mediated immune ( CMI ) responses , and vaccine safety .
METHODS	Healthy adults ( aged 19-40 years ) were randomized 1:1:1:1 to receive TIV or saline followed 4 months later by 2 doses , 3 weeks apart , of adjuvanted or nonadjuvanted A ( H1N1 ) pdm09 vaccine and followed up to study end ( day 507 ) .
METHODS	Pre - and postvaccination responses of HI and neutralizing antibody , CD4 ( + ) / CD8 ( + ) T cells , memory B cells , and plasmablasts were assessed .
RESULTS	Ninety-nine of the 133 participants enrolled completed the study .
RESULTS	No vaccine-related serious adverse events were recorded .
RESULTS	In TIV-primed participants , A ( H1N1 ) pdm09-specific antibody and CD4 ( + ) T-cell and memory B-cell responses to the pandemic vaccine tended to be diminished .
RESULTS	Vaccine adjuvantation led to increased responses of vaccine-homologous and - heterologous HI and neutralizing antibodies and CD4 ( + ) T cells , homologous memory B cells , and plasmablasts .
CONCLUSIONS	In healthy adults , prior TIV administration decreased humoral and CMI responses to A ( H1N1 ) pdm09 vaccine .
CONCLUSIONS	Adjuvantation of A ( H1N1 ) pdm09 antigen helped to overcome immune interference between the influenza vaccines .
CONCLUSIONS	No safety concerns were observed .
BACKGROUND	Clinical Trials.gov identifier NCT00707967 .

###24428467
BACKGROUND	All-oral combination therapy is desirable for patients with chronic hepatitis C virus ( HCV ) infection .
BACKGROUND	We evaluated daclatasvir ( an HCV NS5A replication complex inhibitor ) plus sofosbuvir ( a nucleotide analogue HCV NS5B polymerase inhibitor ) in patients infected with HCV genotype 1 , 2 , or 3 .
METHODS	In this open-label study , we initially randomly assigned 44 previously untreated patients with HCV genotype 1 infection and 44 patients infected with HCV genotype 2 or 3 to daclatasvir at a dose of 60 mg orally once daily plus sofosbuvir at a dose of 400 mg orally once daily , with or without ribavirin , for 24 weeks .
METHODS	The study was expanded to include 123 additional patients with genotype 1 infection who were randomly assigned to daclatasvir plus sofosbuvir , with or without ribavirin , for 12 weeks ( 82 previously untreated patients ) or 24 weeks ( 41 patients who had previous virologic failure with telaprevir or boceprevir plus peginterferon alfa-ribavirin ) .
METHODS	The primary end point was a sustained virologic response ( an HCV RNA level of < 25 IU per milliliter ) at week 12 after the end of therapy .
RESULTS	Overall , 211 patients received treatment .
RESULTS	Among patients with genotype 1 infection , 98 % of 126 previously untreated patients and 98 % of 41 patients who did not have a sustained virologic response with HCV protease inhibitors had a sustained virologic response at week 12 after the end of therapy .
RESULTS	A total of 92 % of 26 patients with genotype 2 infection and 89 % of 18 patients with genotype 3 infection had a sustained virologic response at week 12 .
RESULTS	High rates of sustained virologic response at week 12 were observed among patients with HCV subtypes 1a and 1b ( 98 % and 100 % , respectively ) and those with CC and non-CC IL28B genotypes ( 93 % and 98 % , respectively ) , as well as among patients who received ribavirin and those who did not ( 94 % and 98 % , respectively ) .
RESULTS	The most common adverse events were fatigue , headache , and nausea .
CONCLUSIONS	Once-daily oral daclatasvir plus sofosbuvir was associated with high rates of sustained virologic response among patients infected with HCV genotype 1 , 2 , or 3 , including patients with no response to prior therapy with telaprevir or boceprevir .
CONCLUSIONS	( Funded by Bristol-Myers Squibb and Pharmasset ( Gilead ) ; A1444040 ClinicalTrials.gov number , NCT01359644 . )

###25227220
OBJECTIVE	To explore changes in current source density locations after remifentanil infusion in healthy volunteers using source localization of the electroencephalography ( EEG ) .
METHODS	EEG data was collected from 21 males using a 62-electrode system .
METHODS	Additionally , cognitive performance was evaluated by a continuous reaction time paradigm , and pain scores were obtained for experimental bone and heat stimuli .
METHODS	Data were recorded before and during treatment with remifentanil and placebo .
METHODS	Source localization was performed by sLORETA at delta ( 1-3 .9 Hz ) , theta ( 4-7 .9 Hz ) , alpha ( 8-12 Hz ) , beta1 ( 12.1-18 Hz ) , and beta2 ( 18.1-30 Hz ) frequency bands .
RESULTS	Pre-treatment recordings demonstrated reproducible source characteristics .
RESULTS	The alterations ( i.e. , pre - versus post-treatment ) due to remifentanil were significantly and robustly different from placebo infusions .
RESULTS	The results indicated that neurons in several brain areas including inferior frontal gyrus and insula at frontal lobe oscillated more strongly after remifentanil infusion compared to placebo .
RESULTS	Furthermore , the source activity at delta band was correlated with continuous reaction time index .
CONCLUSIONS	These results indicate that alterations in brain oscillations during remifentanil are mostly localized to frontal , fronto-temporal and fronto-central lobes and related to cognitive function .
CONCLUSIONS	The approach offers the potential to be used for understanding the underlying mechanism of action of remifentanil on brain activity .

###25557838
BACKGROUND	Healthcare workers may be exposed to people with respiratory viral infections more often than other working adults .
BACKGROUND	Understanding the risk and the effectiveness of different preventive measures is of great importance .
OBJECTIVE	To estimate adherence to prophylactic antiviral medication for a full influenza season , to the compare efficacy of antiviral prophylaxis to that of the seasonal influenza vaccine and to identify exposures that increase risk of acute respiratory illnesses ( ARI ) in healthy adults .
METHODS	Participants were randomized 1:2 to receive the 2008-2009 influenza vaccine or daily prophylaxis with 10 mg of zanamivir during the season .
METHODS	Web-based questionnaires collected information on demographics , symptoms , exposures , medication use and side effects .
RESULTS	Sixty-four healthy adults were recruited in November 2008 .
RESULTS	Three of 40 active participants discontinued zanamivir due to side effects ; the remaining 37 took > 85 % of scheduled doses for a median of 121 days .
RESULTS	Symptomatic , laboratory-confirmed influenza was detected in one person randomized to zanamivir ( 25 % ) and 2/20 ( 10 % ) who received the vaccine ( P = 025 ) .
RESULTS	Forty-seven participants reported 109 episodes of ARI .
RESULTS	Factors associated with an ARI were exposure to a spouse ( OR 72 ) , child ( OR 24 ) or patient ( OR 20 ) with symptoms of an ARI in the previous 7 days .
CONCLUSIONS	Breakthrough influenza infection occurred in both vaccinated participants and those receiving antiviral prophylaxis .
CONCLUSIONS	Most adults were willing and able to comply with season-long prophylaxis .
CONCLUSIONS	Report of recent exposure to family members and patients with an ARI increased the risk of developing an ARI in healthy adults .

###25956368
OBJECTIVE	To evaluate risks for adverse pregnancy outcomes by number of embryos transferred ( ET ) and fetal heartbeats ( FHB ) in assisted reproductive technology-conceived singleton live births .
METHODS	Longitudinal cohort using cycles reported to the Society for Assisted Reproductive Technology Clinic Outcomes Reporting System between 2004 and 2008 among women who were treated and gave birth in Massachusetts .
METHODS	Not applicable .
METHODS	Assisted reproductive technology data on 6,073 births between 2004 and 2008 were linked to vital records and hospital data .
METHODS	Likelihood of ET 3 vs. 1-2 , FHB > 1 vs. 1 , and risks of preterm birth ( PTB , < 37weeks ' gestation ) , low birth weight ( LBW , < 2,500 g ) , and small-for-gestational-age birth weight ( SGA , < 10th percentile ) with FHB > 1 were modeled with binary logistic regression using a backward-stepping algorithm , and presented as adjusted odds ratios ( 95 % confidence intervals ) .
METHODS	None .
METHODS	ET 3 , FHB > 1 , PTB , LBW , and SGA .
RESULTS	Higher ET was significantly more likely with older maternal age , intracytoplasmic sperm injection , assisted hatching , cleavage-stage embryos , and thawed embryos .
RESULTS	The likelihood of FHB > 1 with 3 ET vs. 1-2 ET was 2.04 ( 1.68-2 .48 ) .
RESULTS	Risks of PTB and LBW with FHB > 1 were 1.63 ( 1.27-2 .09 ) and 1.81 ( 1.36-2 .39 ) , respectively ; the risk of SGA was not significant .
RESULTS	Nulliparity was associated with higher risks of PTB ( 1.34 [ 1.12-1 .59 ] ) , LBW ( 1.48 [ 1.20-1 .83 ] ) , and SGA ( 2.17 [ 1.69-2 .78 ] ) .
CONCLUSIONS	Number of embryos transferred was strongly associated with FHBs , with twice the risk of FHB > 1 with 3 ET vs. 1-2 ET .
CONCLUSIONS	Increasing FHBs were associated with significantly greater risks for PTB and LBW outcomes .

###25662205
BACKGROUND	The study was designed to compare the effectiveness of 3 video laryngoscopes with the Miller laryngoscope during pediatric resuscitation .
METHODS	This was a randomized crossover study involving 87 paramedics and 54 nurses .
METHODS	The primary end point of the study was the success rate of blind tracheal intubation , whereas the secondary end point was defined as the time from insertion of a device to the first manual ventilation of the manikin 's lungs .
RESULTS	The median time to intubation using the Pentax , Truview , GlideScope , and Miller varied with the times being 20.6 ( interquartile range [ IQR ] , 18-27 ) vs 20.1 ( IQR , 18-23 .3 ) vs 30.2 ( IQR , 29.6-35 ) vs 41.3 ( IQR , 33-45 .2 ) seconds , respectively .
RESULTS	The overall success ratios of intubation for the devices were 100 % vs 100 % vs 100 % vs 79.4 % .
CONCLUSIONS	We concluded that , in a pediatric manikin scenario , the video laryngoscopes are safe devices and can be used for pediatric intubation during uninterrupted chest compressions .
CONCLUSIONS	Further clinical studies are necessary to confirm these initial positive findings .

###25458645
BACKGROUND	Heart failure with preserved ejection fraction ( HFpEF ) comprises a large portion of heart failure patients and portends poor prognosis with similar outcome to heart failure with reduced ejection fraction ( HFrEF ) .
BACKGROUND	Thus far , no medical therapy has been shown to improve clinical outcome in this common condition .
METHODS	The study is a randomized-controlled , multicenter clinical trial aimed to determine whether early posthospitalization comprehensive cardiac rehabilitation ( CR ) including exercise training ( ET ) in recently hospitalized HFpEF patients reduces the composite end point of all-cause mortality and hospitalizations in comparison with usual care ( UC ) .
METHODS	After undergoing baseline evaluation , patients are randomized to either UC or to ambulatory comprehensive CR program .
METHODS	Patients in the CR arm will participate in a 6-month biweekly ET program according to a predefined protocol , in addition to a complementary home exercise prescribed by a specialist in CR .
METHODS	Exercise training will include endurance and low-intensity resistance training .
METHODS	Patients in the UC arm will be followed up at the outpatient clinic , with management according to current heart failure guidelines .
METHODS	Physician follow-up visits will be conducted at 3 , 6 , and 12 months for assessment of adherence to therapy and ET , functional status , quality of life , and clinical events .
METHODS	Secondary end points will include quality-of-life questionnaire , economic end points , blood pressure , and hemoglobin A1C levels .
CONCLUSIONS	Cardiac rehabilitation and ET are relatively inexpensive and accessible and can be beneficial in HFpEF patients .
CONCLUSIONS	Our trial is designed to evaluate the impact of early posthospitalization comprehensive rehabilitation program on clinical end points of mortality , hospitalization , and quality of life in HFpEF patients .

###25624754
BACKGROUND	There is growing evidence that cognitive training ( CT ) can improve the cognitive functioning of the elderly .
BACKGROUND	CT may be influenced by cultural and linguistic factors , but research examining CT programs has mostly been conducted on Western populations .
BACKGROUND	We have developed an innovative electroencephalography ( EEG ) - based brain-computer interface ( BCI ) CT program that has shown preliminary efficacy in improving cognition in 32 healthy English-speaking elderly adults in Singapore .
BACKGROUND	In this second pilot trial , we examine the acceptability , safety , and preliminary efficacy of our BCI CT program in healthy Chinese-speaking Singaporean elderly .
METHODS	Thirty-nine elderly participants were randomized into intervention ( n = 21 ) and wait-list control ( n = 18 ) arms .
METHODS	Intervention consisted of 24 half-hour sessions with our BCI-based CT training system to be completed in 8 weeks ; the control arm received the same intervention after an initial 8-week waiting period .
METHODS	At the end of the training , a usability and acceptability questionnaire was administered .
METHODS	Efficacy was measured using the Repeatable Battery for the Assessment of Neuropsychological Status ( RBANS ) , which was translated and culturally adapted for the Chinese-speaking local population .
METHODS	Users were asked about any adverse events experienced after each session as a safety measure .
RESULTS	The training was deemed easily usable and acceptable by senior users .
RESULTS	The median difference in the change scores pre - and post-training of the modified RBANS total score was 8.0 ( 95 % confidence interval [ CI ] : 0.0-16 .0 , P = 0.042 ) higher in the intervention arm than waitlist control , while the mean difference was 9.0 ( 95 % CI : 1.7-16 .2 , P = 0.017 ) .
RESULTS	Ten ( 30.3 % ) participants reported a total of 16 adverse events - all of which were graded `` mild '' except for one graded `` moderate '' .
CONCLUSIONS	Our BCI training system shows potential in improving cognition in both English - and Chinese-speaking elderly , and deserves further evaluation in a Phase III trial .
CONCLUSIONS	Overall , participants responded positively on the usability and acceptability questionnaire .

###25845222
OBJECTIVE	To investigate short - and long-term benefits and safety of acupoint injection of kakkonein for early - or mid-stage Parkinson 's disease ( PD ) .
METHODS	A total of 135 patients with early - or mid-stage PD were enlisted and 116 cases completed the observation , including 40 cases in the acupoint-injection group , 37 cases in the acupuncture group and 39 cases in the medication group .
METHODS	Patients of the acupoint-injection group were treated by injection of kakkonein ( 2 mL ) into bilateral Fengchi ( GB 20 ) , once very other day for 8 weeks .
METHODS	For acupuncture intervention , bilateral GB 20 acupoints were punctured with filiform needles , once every other day for 8 weeks .
METHODS	Patients of the medication group were treated by oral administration of compound levodopa ( 125 mg/time , twice a day ) for 8 weeks .
METHODS	The disease severity was assessed by using Unified Parkinson 's Disease Rating Scale ( UPDRS , version 3.0 ) before and after treatment , and one month after the treatment .
RESULTS	After the treatment , scores of psychosis , behavior and emotion , daily life activity and motor function were all significantly decreased in the three groups in comparison with pre-treatment in each group ( P < 0.05 ) , suggesting an improvement of the PD patients ' conditions .
RESULTS	The therapeutic effect of acupoint-injection and acupuncture groups was markedly superior to that of the medication group ( P < 0.05 ) .
RESULTS	One-month 's follow-up showed that the scores of behavior-emotion and daily life activity were obviously lower in the acupoint-injection group than in the acupuncture and medication groups ( P < 0.05 ) .
RESULTS	No significant differences were found between the acupuncture and medication groups in down-regulating scores of behavior-emotion , daily life activity and motor function ( P > 0.05 ) .
CONCLUSIONS	Acupoint injection of kakkonein can improve patients ' behavior , emotion , and daily life activity in early - or mid-stage PD patients and has both short - and longer-term benefits .

###25295663
BACKGROUND	Because hydrogen therapy has been found beneficial for the treatment of inflammation , ischemia-reperfusion injury , and oxidative stress in humans , it seems useful to evaluate the effects of exogenously administered hydrogen as an element in the immediate management of sports-related soft tissue injuries .
BACKGROUND	The main aim of this pilot study was to examine the effects of 2-week administration of hydrogen on the biochemical markers of inflammation and functional recovery in male professional athletes after acute soft tissue injury .
METHODS	During the 2013 season ( from March to May ) , 36 professional athletes were recruited as participants and examined by a certified sports medicine specialist in the first 24 hours after an injury was sustained .
METHODS	Subjects were allocated to 3 randomly assigned trials in a single-blind design .
METHODS	Those in the control group received a traditional treatment protocol for soft tissue injury .
METHODS	Subjects in the first experimental group followed the same procedures as the control group but with additional administration throughout the study of oral hydrogen-rich tablets ( 2 g per day ) .
METHODS	Subjects in the second experimental group also followed the procedures of the control group , with additional administration throughout the study of both oral hydrogen-rich tablets ( 2 g per day ) and topical hydrogen-rich packs ( 6 times per day for 20 minutes ) .
METHODS	Participants were evaluated at the time of the injury report and at 7 and 14 days after baseline testing .
RESULTS	Oral and topical hydrogen intervention was found to augment plasma viscosity decrease as compared with the control group ( P = 0.04 ) .
RESULTS	Differences were found for range-of-motion recovery between the 3 groups ; oral and topical hydrogen intervention resulted in a faster return to normal joint range of motion for both flexion and extension of the injured limb as compared with the control intervention ( P < 0.05 ) .
CONCLUSIONS	These preliminary results support the hypothesis that the addition of hydrogen to traditional treatment protocols is potentially effective in the treatment of soft tissue injuries in male professional athletes .
CONCLUSIONS	Trial identification : Clinicaltrials.gov number NCT01759498 .

###24335178
BACKGROUND	The p53 : miR-34a : E2F positive feed-forward loop and the p53 : miR-605 : Mdm2 positive feed-back loop have been identified to be crucial oncogenesis/tumor suppressor-regulating signaling pathways .
BACKGROUND	In this study , we sought to examine the hypothesis that neoadjuvant chemotherapy ( NAC ) is a better approach with improved prognosis and outcomes after laparoscopical radical hysterectomy ( LRH ) on patients with cervical cancer and to elucidate the potential roles of the p53 : miR-34a : E2F1 and the p53 : miR-605 : Mdm2 signaling pathways in this therapy .
METHODS	Twenty-one patients with stage IIB cervical cancer were recruited to this study and they were randomly divided into two groups : LRH ( n = 10 ) and NAC+LRH ( n = 11 ) groups .
METHODS	The NAC+LRH group consisted of 4 cycles of cisplatin , paclitaxel and carboplatin .
METHODS	Complication rates and NAC outcomes ( tumor size changes , 2-year disease-free survival rate , and 2-year overall survival rate ) were compared between the two groups .
METHODS	Expression of p53 , Mdm2 , E2F1 , miR-34a , and miR-605 at mRNA and protein levels from the tumor tissues was analyzed .
RESULTS	We observed that the diameter of tumors following chemotherapy was substantially smaller in the NAC+LRH patients than in LRH patients .
RESULTS	No recurrence or metastasis after surgery was observed in the NAC+LRH patients , whereas 2 out of 10 LRH patients had recurrences and 1 had metastasis .
RESULTS	The 2-year disease-free and overall survival rates were apparently higher in the NAC+LRH group than in the LRH group .
RESULTS	Furthermore , molecular biology analyses revealed that the protein and mRNA levels of p53 were both markedly increased in patients who received NAC than those who did not , and oppositely , the levels of E2F1 and Mdm2 were significantly lower in the NAC+LRH patients than in the LRH patients .
RESULTS	The levels of miR-34a and miR-605 were considerably higher with NAC relative to without NAC .
RESULTS	Among the three anti-cancer drugs included in NAC , cisplatin was found to be the main component that caused increases in p53 protein levels , miR-34a and miR-605 miRNA levels , and decreases in Mdm2 and E2F1 protein levels .
RESULTS	Furthermore , ERK1/2 inhibitor U0126 or TAB1 siRNA mitigated these changes induced by cisplatin .
CONCLUSIONS	These findings not only indicate NAC as a rational approach for better treatment of cervical cancer with improved therapeutic outcomes , due partly to the ability of cisplatin to promote the p53 : miR-34a : E2F1 positive feed-forward loop and the p53 : miR-605 : Mdm2 positive feedback loop .

###25524543
BACKGROUND	Infliximab ( IFX ) , a monoclonal chimeric antibody against tumour necrosis factor ( TNF ) , is effective for induction and maintenance of remission in moderate to severe Crohn 's disease .
BACKGROUND	Discontinuation of IFX maintenance therapy in patients in remission should be considered in order to reduce the potential long-term side effects and lower costs .
METHODS	This is a prospective , double-blind , randomised , placebo-controlled , multicentre study of patients with luminal Crohn 's disease who have been treated with IFX for at least 1year and are in sustained complete clinical , biochemical and endoscopic remission ( ie , Crohn 's Disease Activity Index ( CDAI ) score < 150 , complete mucosal healing and biochemical markers of inflammation within the normal range ) .
METHODS	These patients are randomised to receive placebo infusions or continue IFX maintenance therapy .
METHODS	The primary end point is the proportion of patients in maintained remission after 48weeks ( def .
METHODS	CDAI < 150 ) .
BACKGROUND	It is estimated that the knowledge gained about how to optimally handle patients with Crohn 's disease in complete long-term sustained remission on IFX is proportionate to the risks and inconveniences related to participation in this study .
BACKGROUND	Prolonged exposure to IFX may cause severe side effects and increased risk of malignancies .
BACKGROUND	Conversely , IFX discontinuation should not unnecessarily create a high risk of relapse .
BACKGROUND	Thus , empirical evidence is needed concerning the safety of discontinuing IFX once a patient exhibits sustained remission .
BACKGROUND	Study results will be published in an English language scientific medical journal .
BACKGROUND	The study is approved by the Danish Medicines Agency ( EudraCT-number : 2012-002702-51 ) and the Regional Ethics Committee of Region Hovedstaden Denmark ( Approval-number : H-4-2012-099 ) .
BACKGROUND	The project is reported to the Danish Data Protection Agency ( ID-number : 2007-58-0015 / HEH.750.89-27 ) , registered at Clinicaltrials.gov , and monitored by independent GCP units for the University of Copenhagen , Odense and Aarhus .
BACKGROUND	The current approved protocol is V. 3.2 , dated 1 June 2014 .
BACKGROUND	http://clinicaltrials.gov/show/NCT01817426 .

###25166719
BACKGROUND	MK-5442 is an orally bioavailable calcium-sensing receptor antagonist that is hypothesized to stimulate bone formation by stimulating endogenous secretion of a pulse of PTH .
BACKGROUND	Earlier clinical and preclinical studies demonstrated increased bone mineral density ( BMD ) after treatment .
OBJECTIVE	Our objective was to identify a dose of MK-5442 that produces osteoanabolic effects without excessive hypercalcemia .
METHODS	This was a randomized , double-blind , placebo-controlled , parallel-group trial of private or institutional practice .
METHODS	In total , 383 postmenopausal women with osteoporosis were administered daily oral MK-5442 ( 2.5 , 5 , 7.5 , 10 , or 15 mg ) or placebo .
METHODS	Serum PTH and calcium , bone turnover markers , areal BMD , and safety were evaluated .
RESULTS	A dose-dependent transient increase in PTH occurred after an MK-5442 dose and lasted more than 3.5 hours .
RESULTS	Compared with placebo , significant increases in bone formation markers ( serum procollagen 1 N-terminal peptide and bone-specific alkaline phosphatase ) were observed by 6 months , whereas bone resorption markers ( serum C-telopeptide of type 1 collagen , urine N-telopeptides of type 1 collagen ) initially decreased but were also significantly increased by 6 months .
RESULTS	Despite the biochemical marker changes suggestive of an anabolic response , there were no statistically significant differences between any dose of MK-5442 and placebo in percent change from baseline at month 6 in any of the BMD endpoints .
RESULTS	The frequency of hypercalcemia ( trough serum calcium 10.8 mg/dL ) was greater with higher MK-5442 doses .
CONCLUSIONS	In postmenopausal women with low bone mass , treatment with MK-5442 resulted in transient pulses of PTH .
CONCLUSIONS	Bone formation markers increased quickly and bone resorption markers decreased temporarily , suggestive of an anabolic window .
CONCLUSIONS	However , there were no increases in BMD versus placebo .

###24716681
BACKGROUND	The role of fibrinolytic therapy in patients with intermediate-risk pulmonary embolism is controversial .
METHODS	In a randomized , double-blind trial , we compared tenecteplase plus heparin with placebo plus heparin in normotensive patients with intermediate-risk pulmonary embolism .
METHODS	Eligible patients had right ventricular dysfunction on echocardiography or computed tomography , as well as myocardial injury as indicated by a positive test for cardiac troponin I or troponin T.
METHODS	The primary outcome was death or hemodynamic decompensation ( or collapse ) within 7 days after randomization .
METHODS	The main safety outcomes were major extracranial bleeding and ischemic or hemorrhagic stroke within 7 days after randomization .
RESULTS	Of 1006 patients who underwent randomization , 1005 were included in the intention-to-treat analysis .
RESULTS	Death or hemodynamic decompensation occurred in 13 of 506 patients ( 2.6 % ) in the tenecteplase group as compared with 28 of 499 ( 5.6 % ) in the placebo group ( odds ratio , 0.44 ; 95 % confidence interval , 0.23 to 0.87 ; P = 0.02 ) .
RESULTS	Between randomization and day 7 , a total of 6 patients ( 1.2 % ) in the tenecteplase group and 9 ( 1.8 % ) in the placebo group died ( P = 0.42 ) .
RESULTS	Extracranial bleeding occurred in 32 patients ( 6.3 % ) in the tenecteplase group and 6 patients ( 1.2 % ) in the placebo group ( P < 0.001 ) .
RESULTS	Stroke occurred in 12 patients ( 2.4 % ) in the tenecteplase group and was hemorrhagic in 10 patients ; 1 patient ( 0.2 % ) in the placebo group had a stroke , which was hemorrhagic ( P = 0.003 ) .
RESULTS	By day 30 , a total of 12 patients ( 2.4 % ) in the tenecteplase group and 16 patients ( 3.2 % ) in the placebo group had died ( P = 0.42 ) .
CONCLUSIONS	In patients with intermediate-risk pulmonary embolism , fibrinolytic therapy prevented hemodynamic decompensation but increased the risk of major hemorrhage and stroke .
CONCLUSIONS	( Funded by the Programme Hospitalier de Recherche Clinique in France and others ; PEITHO EudraCT number , 2006-005328-18 ; ClinicalTrials.gov number , NCT00639743 . )

###24699217
OBJECTIVE	To investigate the effect of lung recruitment maneuver ( LRM ) with positive end-expiratory pressure ( PEEP ) on oxygenation and outcomes in preterm infants ventilated by proportional assist ventilation ( PAV ) for respiratory distress syndrome ( RDS ) .
METHODS	Preterm infants on PAV for RDS after surfactant randomly received an LRM ( group A , n = 12 ) or did not ( group B , n = 12 ) .
METHODS	LRM entailed increments of 0.2 cm H2O PEEP every 5 min , until fraction of inspired oxygen ( FiO2 ) = 0.25 .
METHODS	Then PEEP was reduced and the lung volume was set on the deflation limb of the pressure/volume curve .
METHODS	When saturation of peripheral oxygen fell and FiO2 rose , we reincremented PEEP until SpO2 became stable .
RESULTS	Group A and B infants were similar : gestational age 29.5 1.0 vs 29.4 0.9 weeks ; body weight 1314 96 vs 1296 88 g ; Silverman Anderson score for babies at start of ventilation 8.6 0.8 vs 8.2 0.7 ; initial FiO2 0.56 0.16 vs 0.51 0.14 , respectively .
RESULTS	The less doses of surfactant administered in group A than that in group B ( P < 0.05 ) .
RESULTS	Groups A and B showed different max PEEP during the first 12 h of life ( 8.4 0.5 vs 6.7 0.6 cm H2O , P = 0.00 ) , time to lowest FiO2 ( 101 18 versus 342 128 min ; P = 0.000 ) and O2 dependency ( 7.83 2.04 vs 9.92 2.78 days ; P = 0.04 ) .
RESULTS	FiO2 levels progressively decreased ( F = 43.240 , P = 0.000 ) and a/AO2 ratio gradually increased ( F = 30.594 , P = 0.000 ) .
RESULTS	No adverse events and no differences in the outcomes were observed .
CONCLUSIONS	LRM led to the earlier lowest FiO2 of the first 12 h of life and a shorter O2 dependency .

###25070686
OBJECTIVE	The purpose of this study was to evaluate the efficacy and safety of ( 177 ) Lu-EDTMP for pain palliation in patients with bone metastases from castration-resistant prostate and breast cancer .
OBJECTIVE	The secondary objective was to compare low-dose and high-dose ( 177 ) Lu-EDTMP in bone pain palliation .
METHODS	Included in the study were 44 patients with documented breast carcinoma ( 12 patients ; age 4713 years ) or castration-resistant prostate carcinoma ( 32 patients ; age 669 years ) and skeletal metastases .
METHODS	Patients were randomized into two equal groups treated with ( 177 ) Lu-EDTMP intravenously at a dose of 1,295 MBq ( group A ) or 2,590 MBq ( group B ) .
METHODS	Pain palliation was evaluated using a visual analogue score ( VAS ) , analgesic score ( AS ) and Karnofsky performance score ( KPS ) up to 16 weeks .
METHODS	Toxicity was assessed in terms of haematological and renal parameters .
RESULTS	The overall response rate ( in all 44 patients ) was 86 % .
RESULTS	Complete , partial and minimal responses were seen in 6 patients ( 13 % ) , 21 patients ( 48 % ) and 11 patients ( 25 % ) , respectively .
RESULTS	A favourable response was seen in 27 patients ( 84 % ) with prostate cancer and in 11 patients ( 92 % ) with breast cancer .
RESULTS	There was a progressive decrease in the VAS from baseline up to 4 weeks ( p < 0.05 ) .
RESULTS	Also , AS decreased significantly from 1.80.7 to 1.20.9 ( p < 0.0001 ) .
RESULTS	There was an improvement in quality of life of the patients as reflected by an increase in mean KPS from 565 to 757 ( p < 0.0001 ) .
RESULTS	The overall response rate in group A was 77 % compared to 95 % in group B ( p = 0.188 ) .
RESULTS	There was a significant decrease in VAS and AS accompanied by an increase in KPS in both groups .
RESULTS	Nonserious haematological toxicity ( grade I/II ) was observed in 15 patients ( 34 % ) and serious toxicity ( grade III/IV ) occurred in 10 patients ( 23 % ) .
RESULTS	There was no statistically significant difference in haematological toxicity between the groups .
CONCLUSIONS	( 177 ) Lu-EDTMP was found to be a safe and effective radiopharmaceutical for bone pain palliation in patients with metastatic prostate and breast carcinoma .
CONCLUSIONS	There were no differences in efficacy or toxicity between patients receiving low-dose and high-dose ( 177 ) Lu-EDTMP .

###25386018
OBJECTIVE	To determine whether human patient simulation ( HPS ) is superior to case-based learning ( CBL ) in teaching diabetic ketoacidosis ( DKA ) and thyroid storm ( TS ) to pharmacy students .
METHODS	In this cross-over , open-label , single center , randomized control trial , final-year undergraduate pharmacy students enrolled in an applied therapeutics course were randomized to HPS or CBL groups .
METHODS	Pretest , posttest , knowledge retention tests , and satisfaction survey were administered to students .
RESULTS	One hundred seventy-four students participated in this study .
RESULTS	The effect sizes attributable to HPS were larger than CBL in both cases .
RESULTS	HPS groups performed significantly better in posttest and knowledge retention test compared to CBL groups pertaining to TS case ( p < 0.05 ) .
RESULTS	Students expressed high levels of satisfaction with HPS sessions .
CONCLUSIONS	HPS was superior to CBL in teaching DKA and TS to final-year undergraduate pharmacy students .

###25795409
BACKGROUND	Platinum chemotherapy has a role in the treatment of metastatic triple-negative breast cancer but its full potential has probably not yet been reached .
BACKGROUND	We assessed whether a cisplatin plus gemcitabine regimen was non-inferior to or superior to paclitaxel plus gemcitabine as first-line therapy for patients with metastatic triple-negative breast cancer .
METHODS	For this open-label , randomised , phase 3 , hybrid-designed trial undertaken at 12 institutions or hospitals in China , we included Chinese patients aged 18-70 years with previously untreated , histologically confirmed metastatic triple-negative breast cancer , and an ECOG performance status of 0-1 .
METHODS	These patients were randomly assigned ( 1:1 ) to receive either cisplatin plus gemcitabine ( cisplatin 75 mg/m ( 2 ) on day 1 and gemcitabine 1250 mg/m ( 2 ) on days 1 and 8 ) or paclitaxel plus gemcitabine ( paclitaxel 175 mg/m ( 2 ) on day 1 and gemcitabine 1250 mg/m ( 2 ) on days 1 and 8 ) given intravenously every 3 weeks for a maximum of eight cycles .
METHODS	Randomisation was done centrally via an interactive web response system using block randomisation with a size of eight , with no stratification factors .
METHODS	Patients and investigator were aware of group assignments .
METHODS	The primary endpoint was progression-free survival and analyses were based on all patients who received at least one dose of assigned treatment .
METHODS	The margin used to establish non-inferiority was 12 .
METHODS	If non-inferiority of cisplatin plus gemcitabine compared with paclitaxel plus gemcitabine was achieved , we would then test for superiority .
METHODS	The trial is registered with ClinicalTrials.gov , number NCT01287624 .
RESULTS	From Jan 14 , 2011 , to Nov 14 , 2013 , 240 patients were assessed for eligibility and randomly assigned to treatment ( 120 in the cisplatin plus gemcitabine group and 120 in the paclitaxel plus gemcitabine group ) .
RESULTS	236 patients received at least one dose of assigned chemotherapy and were included in the modified intention-to-treat analysis ( 118 per group ) .
RESULTS	After a median follow-up of 163 months ( IQR 144-268 ) in the cisplatin plus gemcitabine group and 159 months ( 107-254 ) in the paclitaxel plus gemcitabine group , the hazard ratio for progression-free survival was 0692 ( 95 % CI 0523-0915 ; pnon-inferiority < 00001 , psuperiority = 0009 , thus cisplatin plus gemcitabine was both non-inferior to and superior to paclitaxel plus gemcitabine .
RESULTS	Median progression-free survival was 773 months ( 95 % CI 616-930 ) in the cisplatin plus gemcitabine group and 647 months ( 576-718 ) in the paclitaxel plus gemcitabine group .
RESULTS	Grade 3 or 4 adverse events that differed significantly between the two groups included nausea ( eight [ 7 % ] vs one [ < 1 % ] ) , vomiting ( 13 [ 11 % ] vs one [ < 1 % ] ) , musculoskeletal pain ( none vs ten [ 8 % ] ) , anaemia ( 39 [ 33 % ] vs six [ 5 % ] ) , and thrombocytopenia ( 38 [ 32 % ] vs three [ 3 % ] ) , for the cisplatin plus gemcitabine compared with the paclitaxel plus gemcitabine groups , respectively .
RESULTS	In addition , patients in the cisplatin plus gemcitabine group had significantly fewer events of grade 1-4 alopecia ( 12 [ 10 % ] vs 42 [ 36 % ] ) and peripheral neuropathy ( 27 [ 23 % ] vs 60 [ 51 % ] ) , but more grade 1-4 anorexia ( 33 [ 28 % ] vs 10 [ 8 % ] ) , constipation ( 29 [ 25 % ] vs 11 [ 9 % ] ) , hypomagnesaemia ( 27 [ 23 % ] vs five [ 4 % ] ) , and hypokalaemia ( 10 [ 8 % ] vs two [ 2 % ] ) .
RESULTS	Serious drug-related adverse events were seen in three patients in the paclitaxel plus gemcitabine group ( interstitial pneumonia , anaphylaxis , and severe neutropenia ) and four in the cisplatin plus gemcitabine group ( pathological bone fracture , thrombocytopenia with subcutaneous haemorrhage , severe anaemia , and cardiogenic syncope ) .
RESULTS	There were no treatment-related deaths .
CONCLUSIONS	Cisplatin plus gemcitabine could be an alternative or even the preferred first-line chemotherapy strategy for patients with metastatic triple-negative breast cancer .
BACKGROUND	Shanghai Natural Science Foundation .

###26062182
OBJECTIVE	To compare the efficacy differences on delayed encephalopathy after carbon monoxide poisoning ( DEACMP ) between acupuncture to restore consciousness combined with hyperbaric oxygen treatment and simple hyperbaric oxygen treatment .
METHODS	Forty-one patients with DEACMP were randomly divided into an observation group ( 21 cases ) and a control group ( 20 cases ) .
METHODS	In the observation group , acupuncture was applied at Neiguan ( PC 6 ) , Shuigou ( GV 26 ) , Baihui ( GV 20 ) , Sishencong ( EX-HN 1 ) , Fengchi ( GB 20 ) , Hegu ( LI 4 ) , Sanyinjiao ( SP 6 ) and Taichong ( LR 3 ) , and hyperbaric oxygen treatment was given as well .
METHODS	In the control group , simple hyperbaric oxygen treatment was used .
METHODS	The treatment was adopted once every day , and continuous 5 days ' treatment made one session in the two groups .
METHODS	There were two days at the interval between two sessions and 6 sessions in the two groups .
METHODS	The changes of scores of mini mental state examination ( MMSE ) and Barthel index ( BI ) for activity of daily life and routine electroencephalogram ( EEG ) before and after treatment were compared .
RESULTS	After treatment , the scores of MMSE and BI and EEG were all improved compared with those before treatment ( all P < 0.01 ) .
RESULTS	The raise of the scores of MMSE and BI in the observation group was more obvious than that in the control group ( both P < 0.05 ) and the improvement of EEG abnormal condition in the observation group was also superior to that in the control group after treatment ( P < 0.05 ) .
CONCLUSIONS	Acupuncture to restore consciousness combined with hyperbaric oxygen could obviously improve the cognitive function , activity of daily life and changes of EEG , and it is better than simple hyperbaric oxygen treatment .

###24736240
OBJECTIVE	Because the blood circulation system of retina and brain are closely related to each other , we examined whether stroke is associated with localized retinal nerve fiber layer defects ( RNFLDs ) .
METHODS	Patients with acute ischemic stroke as part of a hospital-based study group were compared with the participants of the population-based group Beijing Eye Study .
METHODS	The retina was imaged by spectral-domain optical coherence tomography for the detection of localized RNFLDs .
RESULTS	The study included 154 patients with acute ischemic stroke and 2890 subjects from the Beijing Eye Study for whom optical coherence tomographic images of the retinal nerve fiber layer and data on a previous cerebral stroke were available .
RESULTS	In logistic regression analysis , acute stroke was significantly associated with localized RNFLDs ( P < 0.001 ; odds ratio , 6.23 ; 95 % confidence interval , 4.17-9 .30 ) after adjusting for age , male sex , arterial hypertension , diabetes mellitus , and higher concentration of the C-reactive protein .
RESULTS	In a similar manner , previous stroke was associated with localized RNFLDs ( P = 0.04 ; odds ratio , 1.48 ; 95 % confidence interval , 1.02-2 .16 ) in multivariate analysis .
RESULTS	In a reverse manner , presence of localized RNFLDs was associated with cerebral stroke ( P < 0.001 ; odds ratio , 3.54 ; 95 % confidence interval , 2.68-4 .67 ) after adjusting for age , sex , and prevalence of diabetes mellitus .
CONCLUSIONS	Localized RNFLDs showed a strong association with previous or acute cerebrovascular stroke and vice versa after adjustment for other systemic and ocular factors .
CONCLUSIONS	Localized RNFLDs that can be assessed by noninvasive optical coherence tomographic imaging may be added to the panoply of retinal morphological features of stroke .

###25416723
OBJECTIVE	Few data are published on the long-term follow-up of ipilimumab-induced hypophysitis , a cytotoxic T-lymphocyte antigen 4 antibody .
OBJECTIVE	We characterized hypophysitis in terms of clinical signs , endocrinological profile , and imaging at diagnosis and during a long-term follow-up .
METHODS	Fifteen patients , treated for malignant melanoma and who presented ipilimumab-induced hypophysitis , were observed between June 2006 and August 2012 in Timone Hospital , Marseille .
METHODS	Symptoms , pituitary function , and pituitary imaging at diagnosis of hypophysitis and during the follow-up were recorded .
RESULTS	Of 131 patients treated with ipilimumab or a placebo , 15 patients ( 10mg/kg in 11/15 ) presented with hypophysitis ( 11.5 % ) at 9.55.9 weeks ( means.d . )
RESULTS	after treatment start , occurring in 66 % after the third infusion .
RESULTS	The main initial symptoms were headache ( n = 13 ) and asthenia ( n = 11 ) .
RESULTS	All patients but one had at least one hormonal defect : thyrotroph ( n = 13 ) , gonadotroph ( n = 12 ) , or corticotroph ( n = 11 ) deficiencies .
RESULTS	None had diabetes insipidus .
RESULTS	Pituitary imaging showed a moderately enlarged gland in 12 patients .
RESULTS	Clinical symptoms improved rapidly on high-dose glucocorticoids ( n = 11 ) or physiological replacement doses ( n = 4 ) .
RESULTS	At the end of follow-up ( median 33.6 months , range 7-53 .5 ) , corticotroph deficiency remained in 13 patients , 11 recovered thyrotroph and ten gonadotroph functions .
RESULTS	Pituitary imaging remained abnormal in 11 patients .
CONCLUSIONS	Ipilimumab-induced hypophysitis is a common side-effect with frequent hormonal deficiencies at diagnosis .
CONCLUSIONS	Usually , hormonal deficiencies improved , except for corticotroph function .
CONCLUSIONS	Patients receiving these immunomodulatory therapies should be closely monitored especially by systematic baseline hormone measurements after the third infusion and remain at a risk of adrenal insufficiency in the long-term .

###24709016
BACKGROUND	The growing number of web-based psychological treatments , based on textual communication , generates a wealth of data that can contribute to knowledge of online and face-to-face treatments .
BACKGROUND	We investigated whether clients ' language use predicted treatment outcomes and adherence in Master Your Mood ( MYM ) , an online group course for young adults with depressive symptoms .
METHODS	Among 234 participants from a randomised controlled trial of MYM , we tested whether their word use on course application forms predicted baseline levels of depression , anxiety and mastery , or subsequent treatment adherence .
METHODS	We then analysed chat session transcripts of course completers ( n = 67 ) to investigate whether word use changes predicted changes in treatment outcomes .
RESULTS	Depression improvement was predicted by increasing use of ` discrepancy words ' during treatment ( e.g. should ) .
RESULTS	At baseline , more discrepancy words predicted higher mastery level .
RESULTS	Adherence was predicted by more words used at application , more social words and fewer discrepancy words .
CONCLUSIONS	Many variables were included , increasing the chance of coincidental results .
CONCLUSIONS	This risk was constrained by examining only those word categories that have been investigated in relation to depression or adherence .
CONCLUSIONS	This is the first study to link word use during treatment to outcomes of treatment that has proven to be effective in an RCT .
CONCLUSIONS	The results suggest that paying attention to the length of problem articulation at application and to ` discrepancy words ' may be wise , as these seem to be psychological markers .
CONCLUSIONS	To expand knowledge of word use as psychological marker , research on web-based treatment should include text analysis .

###25306810
OBJECTIVE	To investigate the safety and efficiency of the disposable circumcision suture device ( DCSD ) in the surgical treatment of phimosis and redundant prepuce .
METHODS	We randomly assigned 249 outpatients with phimosis or redundant prepuce to be treated with DCSD ( n = 129 ) and by conventional circumcision ( CC , n = 120 ) , respectively .
METHODS	Then we compared the safety and efficiency of the two strategies .
RESULTS	Comparisons between DCSD and CC showed that the operation time was ( 4.02 + / - 0.69 ) vs ( 30.8 + / - 4.05 ) min , blood loss was ( 1.07 + / - 1.29 ) vs ( 8.72 + / - 2.15 ) ml , intraoperative pain score was 0.81 + / - 0.81 vs 2.42 + / - 1.15 , 24-hour postoperative pain score was 1.84 + / - 1.02 vs 4.99 + / - 1.36 , postoperative complication rate was 13.95 % ( 18/129 ) vs 9.17 % ( 11/120 ) , wound healing time was ( 13.99 + / - 9.06 ) vs ( 17.48 + / - 3.49 ) d , satisfaction with the penile appearance was 98.4 % ( 127/129 ) vs 95 % ( 109/120 ) , and treatment cost was ( 2215.62 + / - 17.67 ) vs ( 576.47 + 15.58 ) Y RMB .
RESULTS	DCSD exhibited obvious superiority over CC for shorter operation time , less blood loss , milder intraoperative pain , sooner wound healing , and better penile appearance , but it also had a higher rate of postoperative complications ( P > 0.05 ) and involved more treatment cost than the latter ( P < 0.05 ) .
CONCLUSIONS	The disposable circumcision suture device affords ideal clinical effects and therefore deserves clinical popularization .

###25912051
OBJECTIVE	To report tolerability findings and maintenance of seizure control from a pooled analysis of phase I open-label trial OV-1015 ( NCT01079351 ) and phase III study 13181A ( NCT01128959 ) .
METHODS	Patients receiving a stable oral dosage of carbamazepine were switched to an intravenous ( IV ) carbamazepine formulation solubilized in a cyclodextrin matrix ( at a 70 % dosage conversion ) for either a 15 - or a 30-min infusion every 6 h for up to 7 days and then switched back .
METHODS	A subset of patients who tolerated 15-min infusions also received 2 - to 5-min ( rapid ) infusions .
METHODS	Assessments included physical and laboratory evaluations , electrocardiography ( ECG ) studies , as well as adverse event ( AE ) monitoring for tolerability .
METHODS	Convulsion/seizure AE terms and data from seizure diaries were used as proxies for the assessment of consistency of seizure control between formulations .
RESULTS	Of the 203 patients exposed to IV carbamazepine ( 30 min , n = 43 ; 15 min , n = 160 ) , 113 received 149 rapid infusions .
RESULTS	During infusion , the most commonly reported AEs ( 5 % ) were dizziness ( 19 % ) , somnolence ( 6 % ) , headache ( 6 % ) , and blurred vision ( 5 % ) .
RESULTS	IV carbamazepine was not associated with clinically relevant cardiac AEs .
RESULTS	The tolerability profile appeared similar between patients who received < 1,600 mg/day ( n = 174 ) and 1,600 mg/day ( n = 29 ) carbamazepine .
RESULTS	Cyclodextrin exposure was not associated with clinically relevant changes in AEs or renal biomarkers .
RESULTS	Seizure control was maintained as patients transitioned between oral and IV carbamazepine .
CONCLUSIONS	IV carbamazepine administered as multiple 30 - or 15-min infusions every 6 h , and as a single rapid infusion , was well tolerated as a short-term replacement in adults with epilepsy receiving stable dosages of oral carbamazepine .
CONCLUSIONS	Infusion site reactions , which were generally mild , were the only unique AEs identified ; seizure control was generally unchanged when patients were switching between formulations .

###24940324
BACKGROUND	postoperative sore throat is the commonest complication after endotracheal intubation .
BACKGROUND	The efficacy of intravenous non-steroidal anti-inflammatory drugs in alleviating postoperative sore throat has not been investigated .
OBJECTIVE	To evaluate the effect of intravenous diclofenac sodium on the occurrence and severity of postoperative sore throat .
METHODS	42 in-patients scheduled for laparoscopic surgery were randomized into two equal groups to receive either a single dose of 75mg intravenous diclofenac sodium in addition to standard treatment taken at our hospital for the prevention of postoperative sore throat or to receive standard treatment only .
METHODS	All patients were interviewed postoperatively at 2 , 6 and 18 hours .
METHODS	Data of the baseline characteristics , the incidence and severity of sore throat were collected .
METHODS	If sore throat was present , a Visual Analogue Score was used to assess its severity .
RESULTS	the baseline characteristics of the participants were similar .
RESULTS	The majority of the patients undergoing laparoscopic surgery were women .
RESULTS	There was no statistically significant difference in the occurrence or severity of postoperative sore throat between the diclofenac and standard treatment groups at 2 , 6 and 18 hours postoperatively .
CONCLUSIONS	Intravenous diclofenac sodium does not reduce the occurrence or severity of postoperative sore throat .

###24787561
BACKGROUND	Several studies have demonstrated subpar chest compression ( CC ) performance by trained health care professionals .
BACKGROUND	The objective of this study was to determine the immediate and sustained effect of instantaneous audiovisual feedback on CC quality .
METHODS	A prospective , randomized , crossover study measuring the effect of audiovisual feedback training on the performance of CCs by health care providers and medical students in a simulated cardiopulmonary arrest scenario was performed .
METHODS	Compression rate , hand placement , depth , and recoil were collected using 60-second epochs of CC on a simulation mannequin .
RESULTS	Data from 200 initial enrollments and 100 tested 1 year later were analyzed by evaluators using standard criterion .
RESULTS	At initial testing , feedback trainees demonstrated significantly improved depth compliance , recoil compliance , and accuracy of hand placement .
RESULTS	One year later , the previous year 's control group now receiving feedback demonstrated immediate improvement in depth , hand placement , and rate .
RESULTS	In the feedback group , the only statistically significant improvement from initial baseline to the baseline 1 year later was an 18 % improvement in depth compliance .
RESULTS	However , the same improvement rate was seen in the control group .
RESULTS	Improved depth compliance performance was correlated to the number of cardiopulmonary resuscitation training sessions received external to the study .
CONCLUSIONS	Instantaneous audiovisual feedback training on CC quality produces immediate improvements in compression rate , hand placement , as well as depth and recoil compliance .
CONCLUSIONS	These improvements , however , are not retained 1 year later .
CONCLUSIONS	Improved depth performance may be correlated to an increased training frequency .

###25100135
OBJECTIVE	To evaluate the pharmacokinetics , safety and survival of trabectedin , metabolized primarily by cytochrome P450 ( CYP ) 3A4 enzyme , when coadministered with rifampin ( CYP3A4 inducer ) or ketoconazole ( CYP3A4 inhibitor ) in adult patients with advanced solid tumors .
METHODS	Two phase 1/2a , 2-way crossover studies were conducted .
METHODS	For rifampin study , 12 patients were randomized ( 1:1 ) to sequence of a cycle of trabectedin ( 1.3 mg/m ( 2 ) , 3 h , i.v. ) coadministered with rifampin ( 600 mg/day , 6-days ) , and a cycle of trabectedin monotherapy ( 1.3 mg/m ( 2 ) , 3 h , i.v. ) .
METHODS	In ketoconazole study , eight patients were randomized ( 1:1 ) to sequence of a cycle of trabectedin ( 0.58 mg/m ( 2 ) , 3 h , i.v. ) coadministered with ketoconazole ( 200 mg , twice-daily , 15-doses ) , and a cycle of trabectedin monotherapy ( 1.3 mg/m ( 2 ) , 3 h , i.v. ) .
RESULTS	The systemic exposure ( geometric means ) of trabectedin was decreased [ 22 % ( C max ) and 31 % ( AUClast ) ] with rifampin coadministration and increased [ 22 % ( C max ) and 66 % ( AUClast ) ] with ketoconazole coadministration .
RESULTS	This correlated with an increased clearance with rifampin ( 39.6-59 .8 L/h ) and a decreased clearance with ketoconazole ( 20.3-12 .0 L/h ) .
RESULTS	Consistent with earlier studies , the most common ( 40 % ) treatment-emergent adverse events in both studies were nausea , vomiting , diarrhea , hepatic function abnormal , anemia , neutropenia , thrombocytopenia and leukopenia .
CONCLUSIONS	Coadministration of rifampin or ketoconazole altered the pharmacokinetics of trabectedin , but no new safety signals were observed .
CONCLUSIONS	Coadministration of trabectedin with potent CYP3A4 inhibitors or inducers should be avoided if possible .
CONCLUSIONS	If coadministration of trabectedin with a strong CYP3A4 inhibitor is required , close monitoring for toxicities is recommended , so that appropriate dose reductions can be instituted as warranted .

###25304187
BACKGROUND	Anaemia in pregnancy is a major public health problem especially in the low-income countries where it is highly prevalent .
BACKGROUND	There has been no recent study in Uganda about the factors associated with anaemia in pregnancy .
BACKGROUND	We aimed to assess the current haemoglobin ( Hb ) status and factors associated with anaemia ( Hb < 11.0 g/dl ) in pregnant women in Mpigi , Uganda .
METHODS	We assessed Hb levels of 2436 pregnant women at 28 + weeks of gestation at six health facilities , who were approached to participate in a stepped-wedge cluster-randomised trial of antenatal distribution of misoprostol ( for self-administration after home birth or when oxytocin is not available ) .
METHODS	Women were administered a questionnaire and their baseline blood haemoglobin was examined using portable HemoCueR Hb 301 system .
METHODS	Predictors of anaemia were estimated using linear and logistic regression analysis .
RESULTS	The mean Hb was 11.5 ( 1.38 ) g/dl and prevalence of anaemia ( Hb < 11.0 g/dl ) was 32.5 % ( 95 % CI 30.6 % , 34.3 % ) .
RESULTS	After adjusting for measured confounders , factors associated with increased risk of anaemia in pregnancy were malaria infection ( OR : 1.32 , 95 % CI : 1.11 , 1.58 ) , Human Immuno-deficiency Virus infection ( OR : 2.13 , 95 % CI : 1.36 , 2.90 ) and lack of iron supplementation ( OR : 1.66 , 95 % CI : 1.36 , 2.03 ) .
RESULTS	Intermittent presumptive treatment of malaria , maternal age and parity showed a weak association with anaemia in pregnancy
CONCLUSIONS	The high prevalence of anaemia in pregnancy in our setting highlights the need to put more effort in the fight against malaria and HIV , and also ensure that pregnant women access iron supplements early in pregnancy .

###24793365
BACKGROUND	Cannabis is widely abused , and efficacies of therapeutics for cannabis dependence remain suboptimal .
BACKGROUND	Magnetic resonance imaging ( MRI ) may aid in the identification of biological markers for successful treatment outcomes ( i.e. , abstinence ) .
METHODS	Twenty men with cannabis dependence and twenty non-substance-using healthy comparison ( HC ) men underwent MRI scanning .
METHODS	Cannabis-dependent individuals then participated in a 12-week randomized clinical trial of behavioral treatments ( contingency management ( CM ) , cognitive behavioral therapy ( CBT ) or both ) .
METHODS	Pretreatment functional and structural data were compared between the cannabis-dependent and HC participants .
METHODS	In addition , individuals with cannabis dependence were subdivided based on the successful achievement of 21 days of consecutive abstinence during treatment to assess whether abstinent versus non-abstinent cannabis-dependent participants displayed different pretreatment functional and structural characteristics when compared to HC participants .
RESULTS	In comparison to HC participants , cannabis-dependent participants demonstrated greater ventral striatal activation during the receipt of losing outcomes and smaller putamenal volumes .
RESULTS	Cannabis-dependent participants who did not subsequently achieve 21 days of consecutive abstinence had increased activity within the striatum during the receipt of losing outcomes , relative to HC participants .
RESULTS	Cannabis-dependent participants who did not achieve 21 days of abstinence had decreased bilateral putamen volumes prior to treatment , relative to HC participants .
CONCLUSIONS	Individual differences in pretreatment striatal function and structure may relate to individual differences in treatment responses for cannabis dependence .
CONCLUSIONS	While mechanisms underlying these associations require further exploration , the striatum might mediate treatment responses via its role in associative reward-learning ( e.g. , through skills training in CBT or reinforcement of abstinence in CM ) .

###25538166
OBJECTIVE	To assess LDL subfraction phenotype and lipoprotein-associated phospholipase A2 ( Lp-PLA2 ) in naive HIV-infected patients starting atazanavir/ritonavir or darunavir/ritonavir plus tenofovir/emtricitabine .
METHODS	This was a substudy of a multicentre randomized study .
METHODS	Standard lipid parameters , LDL subfraction phenotype ( by gradient gel electrophoresis ) and Lp-PLA2 activity ( by 2-thio-PAF ) were measured at baseline and weeks 24 and 48 .
METHODS	Multivariate regression analysis was performed .
METHODS	Results are expressed as the median ( IQR ) .
RESULTS	Eighty-six ( atazanavir/ritonavir , n = 45 ; darunavir/ritonavir , n = 41 ) patients were included : age 36 ( 31-41 ) years ; 89 % men ; CD4 319 ( 183-425 ) cells/mm ( 3 ) ; and Framingham score 1 % ( 0 % -2 % ) .
RESULTS	No differences in demographics or lipid measurements were found at baseline .
RESULTS	At week 48 , a mild but significant increase in total cholesterol and HDL-cholesterol was observed in both arms , whereas LDL cholesterol increased only in the darunavir/ritonavir arm and triglycerides only in the atazanavir/ritonavir arm .
RESULTS	The apolipoprotein A-I/apolipoprotein B ratio increased only in the atazanavir/ritonavir arm .
RESULTS	At week 48 , the LDL subfraction phenotype improved in the darunavir/ritonavir arm ( increase in LDL particle size and in large LDL particles ) , whereas it worsened in the atazanavir/ritonavir arm ( increase in small and dense LDL particles , shift to a greater prevalence of phenotype B ) ; the worsening was related to the greater increase in triglycerides in the atazanavir/ritonavir arm .
RESULTS	No changes in total Lp-PLA2 activity or relative distribution in LDL or HDL particles were found at week 48 in either arm .
CONCLUSIONS	In contrast with what occurred in the atazanavir/ritonavir arm , the LDL subfraction phenotype improved with darunavir/ritonavir at week 48 .
CONCLUSIONS	This difference was associated with a lower impact on plasma triglycerides with darunavir/ritonavir .

###24522170
OBJECTIVE	To compare once - versus twice-daily insulin detemir added on OADS therapy in insulin-naive type 2 diabetes patients in terms of efficacy and safety .
METHODS	An open-label study performed at a single center , comprised a randomized , crossover 24 week with insulin-naive type 2 diabetes patients .
METHODS	Insulin detemir was initiated with mean 0.12 U/kg in all patients ( Group I once-daily , Group II twice-daily ) and titrated for 24 week .
RESULTS	A total of 50 patients completed the study ( Group I n :25 , Group II n :25 ) .
RESULTS	With use of once - and twice-daily insulin , HbA1c values were decreased by 1.8 % ( 2.0 ) and 1.5 % ( 1.4 ) within the first 12 weeks ( p < 0.01 ) , whereas increased by 0.21 % ( 0.7 ) and 0.14 % ( 0.8 ) in the second 12 weeks ( p > 0.05 ) .
RESULTS	The increases in the insulin doses were found as 0.22 U/kg and 0.35 U/kg with once - and twice-daily insulin use , respectively ( p :0.04 ) .
RESULTS	Although minor hypoglycemic events were similar in both groups in the first 12 weeks , 2-fold increase was found in the patients shifting from once - to twice-daily dose .
RESULTS	Within the first and second periods , the body weight of the patients was observed an increase of 0.4 and 1.6 kg with once-daily dose , whereas a decrease of 0.1 and 2.1 kg in the twice-daily dose , in the same period .
CONCLUSIONS	Once-daily use of insulin detemir up to 0.4 U/kg was found to have similar efficacy and safety as twice-daily use .
CONCLUSIONS	Twice dose use of insulin did not provide a prominent glycemic control advantage on 1.5-fold higher use of insulin .

###25559818
OBJECTIVE	We investigated whether mutations in the gene encoding the phosphatidylinositol 3-kinase ( PI3K ) catalytic subunit ( PIK3CA ) correlates with response to neoadjuvant human epidermal growth factor receptor 2 ( HER2 ) - targeted therapies in patients with breast cancer .
METHODS	Baseline tissue biopsies were available from patients with HER2-positive early breast cancer who were enrolled onto the Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimization trial ( NeoALTTO ) .
METHODS	Activating mutations in PIK3CA were identified using mass spectrometry-based genotyping .
RESULTS	PIK3CA mutations were identified in 23 % of HER2-positive breast tumors , and these mutations were associated with poorer outcome in all of the treatment arms .
RESULTS	Patients treated with a combination of trastuzumab and lapatinib who had wild-type PIK3CA obtained a total pathologic complete response ( pCR ) rate of 53.1 % , which decreased to 28.6 % in patients with tumors that carried PIK3CA activating mutations ( P = .012 ) .
CONCLUSIONS	Activating mutations in PIK3CA predicted poor pCR in patients with HER2-positive breast cancer treated with neoadjuvant therapies that target HER2 .
CONCLUSIONS	Consequently , the combination of anti-HER2 agents and PI3K inhibitors is being investigated .

###24521993
BACKGROUND	Intravenous rituximab is a mainstay of treatment for follicular lymphoma .
BACKGROUND	A subcutaneous formulation that achieves equivalent rituximab serum concentrations might improve convenience and save health-care resources without sacrificing clinical activity .
BACKGROUND	We aimed to assess pharmacokinetic non-inferiority of 3 week cycles of fixed-dose subcutaneous rituximab versus standard intravenous rituximab .
METHODS	In our two-stage , randomised , open-label , phase 3 trial , we enrolled patients with previously untreated grade 1-3a , CD20-positive follicular lymphoma at 67 centres in 23 countries .
METHODS	In stage 1 , we randomly allocated patients 1:1 with the Pocock and Simon algorithm to intravenous rituximab ( 375 mg/m ( 2 ) ) or fixed-dose subcutaneous rituximab ( 1400 mg ) , stratified by induction chemotherapy regimen ( cyclophosphamide , doxorubicin , vincristine , prednisone or cyclophosphamide , vincristine , prednisone ) , Follicular Lymphoma International Prognostic Index score , and region .
METHODS	After randomisation , patients received one induction dose of intravenous rituximab in cycle 1 and then allocated treatment for cycles 2-8 .
METHODS	Patients with a complete or partial response following induction therapy continued intravenous or subcutaneous rituximab as maintenance every 8 weeks .
METHODS	The primary endpoint was the ratio of observed rituximab serum trough concentrations ( Ctrough ) between groups at cycle 7 ( before cycle 8 dosing ) of induction treatment in a per-protocol population .
METHODS	Patients were analysed as treated for safety endpoints .
METHODS	Stage 2 follow-up is ongoing and is fully accrued .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01200758 .
RESULTS	Between Feb 4 , 2010 , and Oct 21 , 2011 , we enrolled 127 patients .
RESULTS	Pharmacokinetic data were available for 48 ( 75 % ) of 64 patients randomly allocated intravenous rituximab and 54 ( 86 % ) of 63 patients randomly allocated subcutaneous rituximab .
RESULTS	Geometric mean Ctrough was 8313 g/mL in the intravenous group and 13458 g/mL in the subcutaneous group ( ratio 162 , 90 % CI 136-194 ) , showing non-inferiority of subcutaneous rituximab .
RESULTS	57 ( 88 % ) of 65 patients in the intravenous rituximab safety population had adverse events ( 30 [ 46 % ] grade 3 ) , as did 57 ( 92 % ) of 62 patients in the subcutaneous rituximab safety population ( 29 [ 47 % ] grade 3 ) .
RESULTS	The most common grade 3 or worse adverse event in both groups was neutropenia ( 14 [ 22 % ] patients in the intravenous group and 16 [ 26 % ] patients in the subcutaneous group ) .
RESULTS	Adverse events related to administration were mostly grade 1-2 and occurred in 21 ( 32 % ) patients in the intravenous group and 31 ( 50 % ) patients in the subcutaneous group .
CONCLUSIONS	Stage 1 data show that the pharmacokinetic profile of subcutaneous rituximab was non-inferior to intravenous rituximab and was not associated with new safety concerns .
CONCLUSIONS	Stage 2 will provide data for efficacy and safety of the subcutaneous administration .
BACKGROUND	F Hoffmann-La Roche .

###24613094
OBJECTIVE	To evaluate mediators of resumption of menses ( ROM ) in adolescents with anorexia nervosa ( AN ) .
METHODS	Anthropometrics , body composition by dual-energy X-ray absorptiometry , hormonal studies , and responses to mental health screens were obtained at 6-month intervals for 18 months in 37 adolescents with AN randomized to the placebo arm of a double-blind treatment trial .
METHODS	Outcomes were compared between subjects with menstrual recovery and those without .
RESULTS	Twenty-four subjects ( 65 % ) had ROM .
RESULTS	Higher percentage body fat was associated with ROM ( odds ratio , 1.19 ; 95 % confidence interval , 1.06 , 1.33 ; p < .01 ) , as was body mass index and percent median body weight .
RESULTS	Estradiol 30 ng/mL alone did not predict menses ( p = .08 ) but was associated with ROM when coupled with percent mean body weight ( odds ratio , 2.49 ; 95 % confidence interval , 1.09 , 5.65 ; p = .03 ) .
RESULTS	Changes in leptin , cortisol , and mental health were not associated with return of menses .
CONCLUSIONS	Percentage body fat may be an additional , useful clinical assessment to follow in caring for adolescents with AN .

###24302596
BACKGROUND	This study aimed to analyse data from two different studies ( phase II and phase III ) regarding the safety and efficacy of treatment with alum formulated glutamic acid decarboxylase GAD65 ( GAD-alum ) at 30 months after administration to children and adolescents with type 1 diabetes .
METHODS	The phase II trial was a double-blind , randomised placebo-controlled study , including 70 children and adolescents who were followed for 30 months .
METHODS	Participants received a subcutaneous injection of either 20g of GAD-alum or placebo at baseline and 1month later .
METHODS	During a subsequent larger European phase III trial including three treatment arms , participants received two or four subcutaneous injections of either 20g of GAD-alum and/or placebo at baseline , 1 , 3 and 9 months .
METHODS	The phase III trial was prematurely interrupted at 15months , but of the 148 Swedish patients , a majority completed the 21months follow-up , and 45 patients completed the trial at 30months .
METHODS	Both studies included GAD65 auto-antibodies-positive patients with fasting C-peptide 0.10 nmol/l .
METHODS	We have now combined the results of these two trials .
RESULTS	There were no treatment related adverse events .
RESULTS	In patients treated with 2 GAD-alum doses , stimulated C-peptide area under the curve had decreased significantly less ( 9 m : p < 0.037 ; 15m : p < 0.032 ; 21m : p < 0.003 and 30 m : p < 0.004 ) , and a larger proportion of these patients were also able to achieve a peak stimulated C-peptide > 0.2 nmol/L ( p < 0.05 ) , as compared with placebo .
CONCLUSIONS	Treatment with two doses of GAD-alum in children and adolescents with recent-onset type 1 diabetes shows no adverse events and preserves residual insulin secretion .

###25409877
BACKGROUND	Studies have shown sodium restriction to have a beneficial effect on blood pressure ( BP ) of hypertensive patients .
OBJECTIVE	To evaluate the impact of light salt substitution for regular salt on BP of hypertensive patients .
METHODS	Uncontrolled hypertensive patients of both sexes , 20 to 65 years-old , on stable doses of antihypertensive drugs were randomized into Intervention Group ( IG - receiving light salt ) and Control Group ( CG - receiving regular salt ) .
METHODS	Systolic BP ( SBP ) and diastolic BP ( DBP ) were analyzed by using casual BP measurements and Home Blood Pressure Monitoring ( HBPM ) , and sodium and potassium excretion was assessed on 24-hour urine samples .
METHODS	The patients received 3 g of salt for daily consumption for 4 weeks .
RESULTS	The study evaluated 35 patients ( 65.7 % women ) , 19 allocated to the IG and 16 to the CG .
RESULTS	The mean age was 55.5 7.4 years .
RESULTS	Most participants had completed the Brazilian middle school ( up to the 8th grade ; n = 28 ; 80.0 % ) , had a family income of up to US$ 600 ( n = 17 ; 48.6 % ) and practiced regular physical activity ( n = 19 ; 54.3 % ) .
RESULTS	Two patients ( 5.7 % ) were smokers and 40.0 % consumed alcohol regularly ( n = 14 ) .
RESULTS	The IG showed a significant reduction in both SBP and DBP on the casual measurements and HBPM ( p < 0.05 ) and in sodium excretion ( p = 0.016 ) .
RESULTS	The CG showed a significant reduction only in casual SBP ( p = 0.032 ) .
CONCLUSIONS	The light salt substitution for regular salt significantly reduced BP of hypertensive patients .

###24401715
BACKGROUND	Nonalcoholic fatty liver disease ( NAFLD ) is the most common chronic liver disease in the world .
BACKGROUND	Oral administration of synbiotic has been proposed as an effective treatment of NAFLD because of its modulating effect on the gut flora , which can influence the gut-liver axis .
OBJECTIVE	The objective was to evaluate the effects of supplementation with synbiotic on hepatic fibrosis , liver enzymes , and inflammatory markers in patients with NAFLD .
METHODS	In a randomized , double-blind , placebo-controlled clinical trial conducted as a pilot study , 52 patients with NAFLD were supplemented twice daily for 28 wk with either a synbiotic or a placebo capsule .
METHODS	Both groups were advised to follow an energy-balanced diet and physical activity recommendations .
RESULTS	At the end of the study , the alanine aminotransferase ( ALT ) concentration decreased in both groups ; this reduction was significantly greater in the synbiotic group .
RESULTS	At the end of the study , the following significant differences [ means ( 95 % CIs ) ] were seen between the synbiotic and placebo groups , respectively : ALT [ -25.1 ( -26.2 , -24 ) compared with -7.29 ( -9.5 , -5.1 ) IU/L ; P < 0.001 ] , aspartate aminotransferase [ -31.33 ( -32.1 , -30.5 ) compared with -7.94 ( -11.1 , -4.8 ) IU/L ; P < 0.001 ] , - glutamyltransferase [ -15.08 ( -15.5 , -14.7 ) compared with -5.21 ( -6.6 , -3.9 ) IU/L ; P < 0.001 ] , high-sensitivity C-reactive protein [ -2.3 ( -3 , -1.5 ) compared with -1.04 ( -1.5 , -0.6 ) mmol/L ; P < 0.05 ] , tumor necrosis factor - [ -1.4 ( -1.7 , -1.1 ) compared with -0.59 ( -0.8 , -0.3 ) mmol/L ; P < 0.001 ] , total nuclear factor - B p65 [ -0.016 ( -0.022 , -0.011 ) compared with 0.001 ( -0.004 , -0.007 ) mmol/L ; P < 0.001 ] , and fibrosis score as determined by transient elastography [ - 2.98 ( -3.6 , -2.37 ) compared with -0.77 ( -1.32 , -0.22 ) kPa ; P < 0.001 ] .
CONCLUSIONS	Synbiotic supplementation in addition to lifestyle modification is superior to lifestyle modification alone for the treatment of NAFLD , at least partially through attenuation of inflammatory markers in the body .
CONCLUSIONS	Whether these effects will be sustained with longer treatment durations remains to be determined .

###24356074
OBJECTIVE	Recently , aflibercept was proposed with a protocol of a bimonthly fixed regimen .
OBJECTIVE	Our purpose was to evaluate the results of this regimen in patients treated with ranibizumab .
METHODS	We conducted a retrospective analysis of consecutive patients with nave neovascular age-related macular degeneration treated with a bimonthly fixed regimen of intravitreal injections of ranibizumab after 3 monthly injections .
METHODS	Examination was performed every 4 weeks for 52 weeks , with the possibility of unscheduled rescue injections of ranibizumab .
RESULTS	A total of 27 patients , 24 women and 3 men , aged from 68 to 90 years ( mean : 81.2 ) were analyzed ; 25 eyes ( 92.5 % ) lost < 15 letters .
RESULTS	Mean BCVA rose from 58.3 ( range 12.9 ) to 66.7 ( range 14.3 ) letters .
RESULTS	The mean visual gain was 8.40 ( range 13.2 ) letters ; 11 patients ( 40.7 % ) gained 15 letters .
RESULTS	The mean number of injections of ranibizumab was 8.77 .
CONCLUSIONS	Bimonthly intravitreal ranibizumab achieved satisfactory visual results .
CONCLUSIONS	However , patients who required additional injections did not experience significant visual gain .

###25295645
OBJECTIVE	To assess the first-dose effectiveness and tolerability of metadoxine extended release ( MDX ) in adults with predominantly inattentive attention-deficit/hyperactivity disorder ( ADHD-PI ) .
METHODS	In this double-blind , placebo-controlled , crossover study , adults with ADHD-PI were randomized 1:1:1 to receive a single dose of MDX 1400 mg , MDX 700 mg , and placebo ( ClinicalTrials.gov identifier : NCT01685281 ) .
METHODS	The primary efficacy end point was the mean change in the Test of Variables of Attention ( TOVA ) ADHD score from baseline to 3 to 5 hours after drug administration .
METHODS	Secondary assessments included TOVA subscores , TOVA response rates ( defined as an increase of 0.8 points in the TOVA ADHD score ) , and the Cambridge Neuropsychological Automated Test Battery .
METHODS	Safety assessments included adverse events and vital signs .
RESULTS	The intention-to-treat population included 36 patients ( 52.8 % men ; mean age , 32 years ) .
RESULTS	The efficacy of MDX 1400 mg was demonstrated by a statistically significant difference in the mean ( SD ) change in the TOVA ADHD score at baseline to 3 to 5 hours after drug administration compared with placebo ( 2.0 [ 4.2 ] ; P = 0.009 ) .
RESULTS	The TOVA response time variability subscore was significantly different between MDX 1400 mg and placebo ( mean difference , 7.9 [ 19.2 ] points ; P = 0.022 ) .
RESULTS	Significantly more adults responded to single-dose MDX 1400 mg versus placebo ( 97.1 % vs 71.4 % , P = 0.006 ) .
RESULTS	There were no statistically significant differences between MDX 700 mg and placebo on any measures .
RESULTS	Exploratory analyses of the Cambridge Neuropsychological Automated Test Battery did not yield significant findings .
RESULTS	Fatigue and headache were the 2 most frequently reported adverse events .
RESULTS	There were no clinically significant abnormalities in laboratory values , vital signs measurements , Columbia-Suicide Severity Rating Scale scores , or electrocardiographic parameters .
CONCLUSIONS	Single-dose MDX 1400 mg significantly improved sustained and selective attention in adults with ADHD-PI as measured by the TOVA ADHD score 3 to 5 hours after drug administration .
CONCLUSIONS	Single doses of MDX 700 and 1400 mg were well tolerated .

###25872780
BACKGROUND	The insertion of central venous access devices , such as totally implantable venous access ports ( TIVAPs ) , is routine in patients who need a safe and permanent venous access .
BACKGROUND	The number of port implantations is increasing due to the development of innovative adjuvant and neo-adjuvant therapies .
BACKGROUND	Currently , two different strategies are being routinely used : surgical cut-down of the cephalic vein ( vena section ) and direct puncture of the subclavian vein .
BACKGROUND	The aim of this trial is to identify the strategy for the implantation of TIVAPs with the lowest risk of pneumothorax and haemothorax .
METHODS	The PORTAS-3 trial is designed as a multicentre , randomised controlled trial to compare two implantation strategies .
METHODS	A total of 1,154 patients will be randomised after giving written informed consent .
METHODS	Patients must be over 18 years of age and scheduled for primary implantation of a TIVAP on the designated side .
METHODS	The primary endpoint will be the frequency of pneumothorax and haemothorax after insertion of a TIVAP by one of two different strategies .
METHODS	The experimental intervention is as follows : open strategy , defined as surgical cut-down of the cephalic vein , supported by a rescue technique if necessary , and in the case of failure , direct puncture of the subclavian vein .
METHODS	The control intervention is as follows : direct puncture of the subclavian vein using the Seldinger technique guided by sonography , fluoroscopy or landmark technique .
METHODS	The trial duration is approximately 36 months , with a recruitment period of 18 months and a follow-up period of 30 days .
CONCLUSIONS	The PORTAS-3 trial will compare two different TIVAP implantation strategies with regard to their individual risk of postoperative pneumothorax and haemothorax .
CONCLUSIONS	Since TIVAP implantation is one of the most common procedures in general surgery , the results will be of interest for a large community of surgeons as well as oncologists and general practitioners .
CONCLUSIONS	The pragmatic trial design ensures that the results will be generalizable to a wide range of patients .
BACKGROUND	The trial protocol was registered on 28 August 2014 with the German Clinical Trials Register ( DRKS00004900 ) .
BACKGROUND	The World Health Organization 's Universal Trial Number is U1111-1142-4420 .

###24257398
BACKGROUND	We performed this randomized trial to compare the recovery profile of patients receiving single injection ( SISB ) and continuous interscalene brachial plexus block ( CISB ) or general anesthesia ( GA ) for arthroscopic rotator cuff repair surgery through the first postoperative week .
BACKGROUND	Our primary hypothesis was that the highest pain numeric rating scale ( NRS ) ( worst pain score ) at the end of the study week would be lower for patients in the CISB group than for patients in the SISB or GA groups .
METHODS	Seventy-one patients scheduled for elective outpatient arthroscopic rotator cuff repair were enrolled .
METHODS	CISB patients received 20 mL of 0.5 % ropivacaine as a bolus through a catheter , whereas SISB patients received the same injection volume through a needle .
METHODS	CISB patients received an infusion of 0.2 % ropivacaine at 5 mL/h with a patient-controlled bolus of 5 mL hourly for 48 hours .
METHODS	GA-only patients received a standardized general anesthetic .
METHODS	Postoperative highest NRS pain scores through the first postoperative week , time-to-first pain , analgesic consumption , fast-tracked postoperative anesthesia care unit ( PACU ) bypass rate , length of PACU stay , time-to-discharge home , total hours of sleep , and related adverse effects were recorded in the PACU and at home on postoperative days 1 , 2 , 3 , and 7 .
RESULTS	No patient in the CISB or SISB groups reported a NRS 1 or required analgesics while in the PACU .
RESULTS	While most patients in the CISB and SISB groups were fast-tracked to PACU discharge , no patient in the GA group was fast-tracked ( P = 0.003 ) .
RESULTS	Length of stay in the PACU was significantly shorter for the CISB and SISB groups than for the GA group ( 20 31 , 30 42 , and 165 118 minutes , respectively ( CISB vs GA , P < 0.001 ; SISB vs GA , P < 0.001 ) , and time-to-discharge home was significantly shorter when compared with the GA group .
RESULTS	Time to first pain report was longer in the CISB group .
RESULTS	Mean NRS scores were lower for patients in the CISB group than in the SISB and GA groups on postoperative days 1 and 2 , and use of narcotics ( doses 1 ) was lower until postoperative day 3 .
RESULTS	Patients who received CISB slept significantly longer than patients who received SISB or GA ( P < 0.01 ) during the first 48 hours postoperatively .
RESULTS	By the end of the study week , 26 % of patients in the CISB group , 83 % in the SISB group , and 58 % of GA patients reported NRS 4 ( both P-values 0.05 ) .
CONCLUSIONS	The analgesic benefits of CISB found in the PACU and immediately after discharge extend through the intermediate recovery period ending on postoperative day 7 .

###25648341
OBJECTIVE	The present study was designed to understand the role of inflammatory cytokines secreted by corneal epithelial cells in keratoconus ( KC ) and the response to treatment with cyclosporine A ( CyA ) .
METHODS	The study involved 129 Indian KC patients clinically graded according to Amsler-Krumeich classification and 20 healthy , nonectatic subjects as controls .
METHODS	Tear levels of matrix metalloproteinase-9 ( MMP9 ) , interleukin-6 ( IL6 ) , and tumor necrosis factor - ( TNF ) were measured using ELISA kits .
METHODS	Gene expression was measured by qPCR in corneal epithelial cells obtained by debridement from subjects undergoing ocular surface surgeries .
METHODS	In addition , epithelial cells were stimulated with TNF and treated with CyA to study its role on MMP9 expression .
METHODS	Finally , 20 KC patients ( 27 eyes ) with inflammatory symptoms were treated with topical CyA application .
RESULTS	We observed that MMP9 , TNF , and IL6 levels were strongly upregulated at the mRNA level in KC patient epithelia .
RESULTS	Similarly , tears collected from KC patients exhibited high levels of MMP9 and IL6 protein .
RESULTS	Cyclosporine A treatment significantly reduced the mRNA expression levels of IL6 and TNF in both short - and long-term treatments ; however , it reduced MMP9 levels only in long-term treatment in cultured corneal epithelial cells .
RESULTS	Subsequent treatment of KC patients with CyA for approximately 6 months reduced tear MMP9 levels and led to local reduction in corneal curvatures as determined by corneal topography maps .
CONCLUSIONS	The data indicate that corneal epithelium contributes to elevated MMP9 and inflammatory cytokine expression in tears of KC patients .
CONCLUSIONS	Cyclosporine A treatment reduced MMP9 and inflammatory cytokine levels in an in vitro inflammation model system .
CONCLUSIONS	In KC patients , CyA treatment reduced MMP9 levels measured in tears with concomitant arrest of disease progression .
CONCLUSIONS	Therefore , CyA might be a novel treatment strategy in KC patients but requires additional evaluation in larger cohorts .
CONCLUSIONS	( ClinicalTrials.gov number , NCT01746823 . )

###24432622
OBJECTIVE	To evaluate the effectiveness of the monotherapy of Cardura and the combination therapy of Cardura and Tolterodine L-Tartrate Tablets for II ?
OBJECTIVE	benign prostate hyperplasia ( BPH ) with overactive bladder ( OAB ) .
METHODS	This study included 87 cases of BPH with OAB , with a disease course > or = 3 months , daily urination > or = 8 times , nocturnal urination > or = 2 times , urine volume < 200 ml per time , International Prostate Symptom Score ( IPSS ) > or = 8 , OAB symptom score ( OABS ) > or = 3 , quality of life score ( QOL ) > or = 3 , post-void residual ( PVR ) < or = 100 ml , maximum urinary flow ( Qmax ) > or = 5 ml/s , prostate weight 25-50 g , and PSA < 4 microg/L .
METHODS	We randomized the patients to a monotherapy group ( n = 44 ) and combination group ( n = 43 ) , the former treated with Cardura 4 mg qd , and the latter with Cardura 4 mg + Tolterodine L-Tartrate Tablets 4 mg qd , both for 8 weeks .
METHODS	Then we recorded the IPSS , OABS , Qmax , PVR , PSA , and adverse events .
RESULTS	The baseline parameters showed no significant differences between the two groups ( P > 0.05 ) .
RESULTS	In comparison with the baseline , both the monotherapy group and the combination therapy group showed significant decreased in the IPSS ( 16.50 + / - 4.27 vs 13.68 + / - 3.69 and 15.51 + / - 3.80 vs 11.49 + / - 2.75 ) , urine storage symptom score ( 10.48 + / - 2.75 vs 7.98 + / - 2.34 and 9.47 + / - 2.31 vs 5.74 + / - 1.66 ) , OABS ( 8.55 + / - 2.69 vs 6.32 + / - 1.97 and 8.21 + / - 2.55 vs 4.44 + / - 1.62 ) , urgent micturition score ( 4.25 + / - 1.06 vs 3.23 + / - 0.99 and 4.07 + / - 0.83 vs 2.26 + / - 1.05 ) , QOL ( 5.36 + / - 0.72 vs 3.43 + / - 0.66 and 5.07 + / - 0.86 vs 2.37 + / - 0.76 ) and PVR ( [ 44.55 + / - 22.39 ] vs [ 38.30 + / - 20.20 ] ml and [ 36.19 + / - 21.21 ] vs [ 24.98 + / - 17.60 ] ml ) ( P < 0.01 ) .
RESULTS	All the six parameters were significantly more improved in the combination therapy group than in the monotherapy group ( P < 0.01 ) , but there were no remarkable differences between the groups in Qmax and voiding symptom score ( P > 0.05 ) .
RESULTS	Neither group exhibited significant changes in the PSA level and prostate weight after treatment as compared with the baseline ( P > 0.05 ) .
RESULTS	No acute urinary retention and other severe adverse reactions were observed during the medication .
CONCLUSIONS	Both Cardura monotherapy and the combination therapy of Cardura + Tolterodine L-Tartrate Tablets can improve II ?
CONCLUSIONS	BPH with OAB , and the latter has an even better efficacy than the former .

###24952685
OBJECTIVE	This study was conducted to assess the impact of left ventricular ( LV ) lead position on longer-term survival after cardiac resynchronization therapy ( CRT ) .
BACKGROUND	An optimal LV lead position in CRT is associated with improved clinical outcome .
BACKGROUND	A strategy of speckle-tracking echocardiography can be used to guide the implanter to the site of latest activation and away from segments of low strain amplitude ( scar ) .
BACKGROUND	Long-term , prospective survival data according to LV lead position in CRT are limited .
METHODS	Data from a follow-up registry of 250 consecutive patients receiving CRT between June 2008 and July 2010 were studied .
METHODS	The study population comprised patients recruited to the derivation group and the subsequent TARGET ( Targeted Left Ventricular Lead Placement to guide Cardiac Resynchronization Therapy ) randomized , controlled trial .
METHODS	Final LV lead position was described , in relation to the pacing site determined by pre-procedure speckle-tracking echocardiography , as optimal ( concordant/adjacent ) or suboptimal ( remote ) .
METHODS	All-cause mortality was recorded at follow-up .
RESULTS	An optimal LV lead position ( n = 202 ) conferred LV remodeling response superior to that of a suboptimal lead position ( change in LV end-systolic volume : -24 15 % vs. -12 17 % [ p < 0.001 ] ; change in ejection fraction : +7 8 % vs. +4 7 % [ p = 0.02 ] ) .
RESULTS	During long-term follow-up ( median : 39 months ; range : < 1 to 61 months ) , an optimal LV lead position was associated with improved survival ( log-rank p = 0.003 ) .
RESULTS	A suboptimal LV lead placement independently predicted all-cause mortality ( hazard ratio : 1.8 ; p = 0.024 ) .
CONCLUSIONS	An optimal LV lead position at the site of latest mechanical activation , avoiding low strain amplitude ( scar ) , was associated with superior CRT response and improved survival that persisted during follow-up .

###24222009
OBJECTIVE	To determine patient recall of specific risks associated with medication prescription and whether or not handouts are an effective tool to augment the informed consent process .
METHODS	Double-blinded , randomized , controlled trial .
METHODS	Informed consent for prednisone prescriptions was studied by comparing the effect of a verbal discussion ( describing 10 specific adverse drug reactions ) in conjunction with a handout going over same , to a verbal discussion alone .
METHODS	Blinded assessments occurred by telephone interview 2 to 4 weeks following the intervention .
METHODS	Outcomes assessed were the number of risks of prednisone that patients could list and the number of risks they recalled having discussed with their physician .
METHODS	Other demographic details were also collected .
RESULTS	Twenty-five participants were randomly allocated to each group .
RESULTS	Without prompting , the median number of risks spontaneously recalled by the handout group was not significantly different than the control group , and both groups had very low recall ( two vs. one , P = .24 ) .
RESULTS	When provided a list of potential side effects , it was observed that the handout group recalled a higher median number of risks having been discussed with their physician compared to patients in the control group ( eight vs. five , P = .003 ) .
RESULTS	The groups ' demographics were otherwise identical .
CONCLUSIONS	Patients in general did not remember discussing adverse prednisone risks with their physician even a short time after the discussion took place .
CONCLUSIONS	Although the patient handout resulted in improved recall of risks following the prescription of prednisone , its importance in the informed medication consent process remains an open question .
METHODS	1b .

###24909996
OBJECTIVE	Monosymptomatic nocturnal enuresis ( MNE ) is a common sociomedical problem affecting children that may persist until adulthood despite various lines of therapy .
OBJECTIVE	The aim of this study was to assess the efficacy of combined laser acupuncture and desmopressin in managing patients with resistant MNE , compared with their efficacy when used as monotherapy .
METHODS	The study included 186 patients with a mean age of 15.7 years ( range 10-21 years ) presenting with persistent MNE .
METHODS	All patients were evaluated clinically and investigated with urine analysis , plain X-ray of the urinary tract and abdominal ultrasonography .
METHODS	They were randomized into three equal groups based on the line of management : group A , managed with laser acupuncture alone ; group B , managed with desmopressin alone ; and group C , managed with a combination of laser acupuncture and desmopressin , with a treatment course of 3 months and follow-up period of 6 months to record the efficacy of therapy , side-effects and bladder capacity .
RESULTS	A statistically significant higher cure rate was reported in group C patients , being reported in 33 , 35 and 46 patients in groups A , B and C , respectively .
RESULTS	Improvement was reported in 18 , 17 and 13 cases in groups A , B and C , respectively , but the difference was not statistically significant .
RESULTS	Bladder capacity significantly increased only in patients receiving acupuncture ( groups A and C ) .
CONCLUSIONS	Combined laser acupuncture and desmopressin is a promising and valid option to manage resistant cases of MNE .

###24373253
BACKGROUND	Obesity among Black women continues to exceed that of other women .
BACKGROUND	Most weight loss programs created without reference to specific cultural contexts are less effective for Black than White women .
BACKGROUND	Weight control approaches accessible to Black women and adapted to relevant cultural contexts are important for addressing this problem .
BACKGROUND	This paper reports the final results of SisterTalk , the randomized controlled trial of a cable TV weight control program oriented toward Black women .
METHODS	A five group design included a comparison group and a 22 factorial comparison of a ) interactive vs. passive programming and b ) telephone social support vs no telephone support , with 12 weekly initial cable TV programs followed by 4 monthly booster videos .
METHODS	At baseline , 3 , 8 , and 12months post randomization , telephone and in person surveys were administered on diet , physical activity , and physical measurements of height and weight were taken to calculate body mass index ( BMI ) .
METHODS	Analysis of variance ( ANOVA ) was used to examine differences over time , and between treatment and comparison groups .
METHODS	Dose variables reflecting use of the TV/video and written materials were also assessed .
RESULTS	At 3months , BMI , weight , and dietary fat were significantly lower and physical activity significantly higher among women exposed to the Cable TV intervention compared to the wait-list comparison group .
RESULTS	Significant dietary fat differences were still observed at 8 and 12month evaluations , but not BMI or physical activity differences .
RESULTS	Main effects were not observed for interactive programming or enhanced social support at any time point .
RESULTS	Within the intervention group , higher watching of the TV series and higher reading of educational materials were both ( separately ) associated with significantly lower dietary fat .
CONCLUSIONS	Cable TV was an effective delivery channel to assist Black women with weight control , increasing physical activity and decreasing dietary fat during an initial intervention period , but only dietary changes persisted Enhanced social support and the ability to interact with others during the show were not effective complementary intervention components as conducted in this trial .
CONCLUSIONS	Future research to strengthen the ability of this approach to achieve long term effects may offer even more promising outcomes .

###25184864
BACKGROUND	There are limited data on the efficacy of vaccination against confirmed influenza in pregnant women with and those without human immunodeficiency virus ( HIV ) infection and protection of their infants .
METHODS	We conducted two double-blind , randomized , placebo-controlled trials of trivalent inactivated influenza vaccine ( IIV3 ) in South Africa during 2011 in pregnant women infected with HIV and during 2011 and 2012 in pregnant women who were not infected .
METHODS	The immunogenicity , safety , and efficacy of IIV3 in pregnant women and their infants were evaluated until 24 weeks after birth .
METHODS	Immune responses were measured with a hemagglutination inhibition ( HAI ) assay , and influenza was diagnosed by means of reverse-transcriptase-polymerase-chain-reaction ( RT-PCR ) assays of respiratory samples .
RESULTS	The study cohorts included 2116 pregnant women who were not infected with HIV and 194 pregnant women who were infected with HIV .
RESULTS	At 1 month after vaccination , seroconversion rates and the proportion of participants with HAI titers of 1:40 or more were higher among IIV3 recipients than among placebo recipients in both cohorts .
RESULTS	Newborns of IIV3 recipients also had higher HAI titers than newborns of placebo recipients .
RESULTS	The attack rate for RT-PCR-confirmed influenza among both HIV-uninfected placebo recipients and their infants was 3.6 % .
RESULTS	The attack rates among HIV-uninfected IIV3 recipients and their infants were 1.8 % and 1.9 % , respectively , and the respective vaccine-efficacy rates were 50.4 % ( 95 % confidence interval [ CI ] , 14.5 to 71.2 ) and 48.8 % ( 95 % CI , 11.6 to 70.4 ) .
RESULTS	Among HIV-infected women , the attack rate for placebo recipients was 17.0 % and the rate for IIV3 recipients was 7.0 % ; the vaccine-efficacy rate for these IIV3 recipients was 57.7 % ( 95 % CI , 0.2 to 82.1 ) .
CONCLUSIONS	Influenza vaccine was immunogenic in HIV-uninfected and HIV-infected pregnant women and provided partial protection against confirmed influenza in both groups of women and in infants who were not exposed to HIV .
CONCLUSIONS	( Funded by the Bill and Melinda Gates Foundation and others ; ClinicalTrials.gov numbers , NCT01306669 and NCT01306682 . )

###24428912
BACKGROUND	Individuals with a personal or family history of cancer , can opt for genetic counseling and DNA-testing .
BACKGROUND	Approximately 25 % of these individuals experience clinically relevant levels of psychosocial distress , depression and/or anxiety after counseling .
BACKGROUND	These problems are frequently left undetected by genetic counselors .
BACKGROUND	The aim of this study is to evaluate the efficacy of a cancer genetics-specific screening questionnaire for psychosocial problems , the ` Psychosocial Aspects of Hereditary Cancer ( PAHC ) questionnaire ' together with the Distress Thermometer , in : ( 1 ) facilitating personalized counselor-counselee communication ; ( 2 ) increasing counselors ' awareness of their counselees ' psychosocial problems ; and ( 3 ) facilitating the management of psychosocial problems during and after genetic counseling .
METHODS	This multicenter , randomized controlled trial will include 264 individuals undergoing cancer genetic counseling in two family cancer clinics in the Netherlands .
METHODS	Participants will be randomized to either : ( 1 ) an intervention group that completes the PAHC questionnaire , the results of which are made available to the genetic counselor prior to the counseling session ; or ( 2 ) a control group that completes the PAHC questionnaire , but without feedback being given to the genetic counselor .
METHODS	The genetic counseling sessions will be audiotaped for content analysis .
METHODS	Additionally , study participants will be asked to complete questionnaires at baseline , three weeks after the initial counseling session , and four months after a telephone follow-up counseling session .
METHODS	The genetic counselors will be asked to complete questionnaires at the start of and at completion of the study , as well as a checklist directly after each counseling session .
METHODS	The questionnaires/checklists of the study include items on communication during genetic counseling , counselor awareness of their clients ' psychosocial problems , the ( perceived ) need for professional psychosocial support , cancer worries , general distress , specific psychosocial problems , satisfaction with care received , and experience using the PAHC questionnaire .
CONCLUSIONS	This study will provide empirical evidence regarding the efficacy of a relatively brief psychosocial screening questionnaire in terms of facilitating personalized communication , increasing counselors ' awareness , and optimizing management of psychosocial problems in the cancer genetic counseling setting .
BACKGROUND	This study is registered at the Netherlands Trial Register ( NTR3205 ) and ClinicalTrials.gov ( NCT01562431 ) .

###25209975
BACKGROUND	Advanced lung cancer ( LC ) patients and their families have reported low self-efficacy for self-care/caregiving and high rates of distress , yet few programs exist to address their supportive care needs during treatment .
BACKGROUND	This pilot study examined the feasibility , acceptability , and preliminary efficacy of a 6-session , telephone-based dyadic psychosocial intervention that was developed for advanced LC patients and their caregivers .
BACKGROUND	The program was grounded in self-determination theory ( SDT ) , which emphasizes the importance of competence ( self-efficacy ) , autonomy ( sense of choice/volition ) , and relatedness ( sense of belonging/connection ) for psychological functioning .
BACKGROUND	The primary outcomes were patient and caregiver psychological functioning ( depression/anxiety ) and caregiver burden .
BACKGROUND	The secondary outcomes were the SDT constructs of competence , autonomy , and relatedness .
METHODS	Thirty-nine advanced LC patients who were within 1 month of treatment initiation ( baseline ) and their caregivers ( 51 % spouses/partners ) completed surveys and were randomized to the intervention or usual medical care .
METHODS	Eight weeks after baseline , they completed follow-up surveys .
RESULTS	Solid recruitment ( 60 % ) and low attrition rates demonstrated feasibility .
RESULTS	Strong program evaluations ( mean , 8.6 / 10 ) and homework completion rates ( 88 % ) supported acceptability .
RESULTS	Participants receiving the intervention evidenced significant improvements ( P < .0001 ) in depression , anxiety , and caregiver burden in comparison with usual medical care .
RESULTS	Large effect sizes ( d1 .2 ) favoring the intervention were also found for patient and caregiver competence and relatedness and for caregiver autonomous motivation for providing care .
CONCLUSIONS	These findings support intervention feasibility , acceptability , and preliminary efficacy .
CONCLUSIONS	By empowering families with the skills to coordinate care and meet the challenges of LC together , this intervention holds great promise for improving palliative/supportive care services in cancer .

###24899464
OBJECTIVE	Emerging data support bariatric surgery as a therapeutic strategy for management of type 2 diabetes mellitus .
OBJECTIVE	To test the feasibility of methods to conduct a larger multisite trial to determine the long-term effect of Roux-en-Y gastric bypass ( RYGB ) surgery compared with an intensive diabetes medical and weight management ( Weight Achievement and Intensive Treatment [ Why WAIT ] ) program for type 2 diabetes .
METHODS	A 1-year pragmatic randomized clinical trial was conducted in an academic medical institution .
METHODS	Participants included persons aged 21 to 65 years with type 2 diabetes diagnosed more than 1 year before the study ; their body mass index was 30 to 42 ( calculated as weight in kilograms divided by height in meters squared ) and hemoglobin A1c ( HbA1c ) was greater than or equal to 6.5 % .
METHODS	All participants were receiving antihyperglycemic medications .
METHODS	RYGB ( n = 19 ) or Why WAIT ( n = 19 ) including 12 weekly multidisciplinary group lifestyle , medical , and educational sessions with monthly follow-up thereafter .
METHODS	Proportion of patients with fasting plasma glucose levels less than 126 mg/dL and HbA1c less than 6.5 % , measures of cardiometabolic health , and patient-reported outcomes .
RESULTS	At 1 year , the proportion of patients achieving HbA1c below 6.5 % and fasting glucose below 126 mg/dL was higher following RYGB than Why WAIT ( 58 % vs 16 % , respectively ; P = .03 ) .
RESULTS	Other outcomes , including HbA1c , weight , waist circumference , fat mass , lean mass , blood pressure , and triglyceride levels , decreased and high-density lipoprotein cholesterol increased more after RYGB compared with Why WAIT .
RESULTS	Improvement in cardiovascular risk scores was greater in the surgical group .
RESULTS	At baseline the participants exhibited moderately low self-reported quality-of-life scores reflected by Short Form-36 total , physical health , and mental health , as well as high Impact of Weight on Quality of Life-Lite and Problem Areas in Diabetes health status scores .
RESULTS	At 1 year , improvements in Short Form-36 physical and mental health scores and Problem Areas in Diabetes scores did not differ significantly between groups .
RESULTS	The Impact of Weight on Quality of Life-Lite score improved more with RYGB and correlated with greater weight loss compared with Why WAIT .
CONCLUSIONS	In obese patients with type 2 diabetes , RYGB produces greater weight loss and sustained improvements in HbA1c and cardiometabolic risk factors compared with medical management , with emergent differences over 1 year .
CONCLUSIONS	Both treatments improve general quality-of-life measures , but RYGB provides greater improvement in the effect of weight on quality of life .
CONCLUSIONS	These differences may help inform therapeutic decisions for diabetes and weight loss strategies in obese patients with type 2 diabetes until larger randomized trials are performed .
BACKGROUND	clinicaltrials.gov Identifier : NCT01073020 .

###24549549
OBJECTIVE	Atrial fibrillation ( AF ) is the most common rhythm disorder seen in clinical practice .
OBJECTIVE	Antiarrhythmic drugs are effective for reduction of recurrence in patients with symptomatic paroxysmal AF .
OBJECTIVE	Radiofrequency ablation is an accepted therapy in patients for whom antiarrhythmic drugs have failed ; however , its role as a first-line therapy needs further investigation .
OBJECTIVE	To compare radiofrequency ablation with antiarrhythmic drugs ( standard therapy ) in treating patients with paroxysmal AF as a first-line therapy .
METHODS	A randomized clinical trial involving 127 treatment-naive patients with paroxysmal AF were randomized at 16 centers in Europe and North America to received either antiarrhythmic therapy or ablation .
METHODS	The first patient was enrolled July 27 , 2006 ; the last patient , January 29 , 2010 .
METHODS	The last follow-up was February 16 , 2012 .
METHODS	Sixty-one patients in the antiarrhythmic drug group and 66 in the radiofrequency ablation group were followed up for 24 months .
METHODS	The time to the first documented atrial tachyarrhythmia of more than 30 seconds ( symptomatic or asymptomatic AF , atrial flutter , or atrial tachycardia ) , detected by either scheduled or unscheduled electrocardiogram , Holter , transtelephonic monitor , or rhythm strip , was the primary outcome .
METHODS	Secondary outcomes included symptomatic recurrences of atrial tachyarrhythmias and quality of life measures assessed by the EQ-5D tool .
RESULTS	Forty-four patients ( 72.1 % ) in the antiarrhythmic group and in 36 patients ( 54.5 % ) in the ablation group experienced the primary efficacy outcome ( hazard ratio [ HR ] , 0.56 [ 95 % CI , 0.35-0 .90 ] ; P = .02 ) .
RESULTS	For the secondary outcomes , 59 % in the drug group and 47 % in the ablation group experienced the first recurrence of symptomatic AF , atrial flutter , atrial tachycardia ( HR , 0.56 [ 95 % CI , 0.33-0 .95 ] ; P = .03 ) .
RESULTS	No deaths or strokes were reported in either group ; 4 cases of cardiac tamponade were reported in the ablation group .
RESULTS	In the standard treatment group , 26 patients ( 43 % ) underwent ablation after 1-year .
RESULTS	Quality of life was moderately impaired at baseline in both groups and improved at the 1 year follow-up .
RESULTS	However , improvement was not significantly different among groups .
CONCLUSIONS	Among patients with paroxysmal AF without previous antiarrhythmic drug treatment , radiofrequency ablation compared with antiarrhythmic drugs resulted in a lower rate of recurrent atrial tachyarrhythmias at 2 years .
CONCLUSIONS	However , recurrence was frequent in both groups .
BACKGROUND	clinicaltrials.gov Identifier : NCT00392054 .

###25393889
OBJECTIVE	Few studies have compared simultaneously different antidepressants in long-term treatment of major depressive disorder ( MDD ) .
OBJECTIVE	Long-term prevention of recurrences should be the main goal of MDD treatment .
OBJECTIVE	The purpose of this study was to compare antidepressants of different pharmacological classes in terms of retention in treatment ( no discontinuation for recurrences , hospitalizations , side effects ) .
METHODS	One hundred and fifty outpatients with an MDD diagnosis , treated with antidepressants in mono-therapy , were included .
METHODS	Follow-up period was set at 24 months , and information have been obtained from charts , interviews with patients and their relatives , and from the Lombardy regional register .
METHODS	A survival analysis ( Kaplan-Meier ) was performed , considering recurrences , hospitalizations , or discontinuation due to side effects as ` death ' events .
RESULTS	In our sample , 48.7 % of the patients presented a recurrence within the first 2 years of treatment .
RESULTS	Bupropion appears less effective in long-term treatment of MDD than the other compared antidepressants , with exception of fluoxetine ( p = 0.09 ) , amitriptyline ( p = 0.13 ) , fluvoxamine ( p = 0.83 ) , venlafaxine ( p = 0.5 ) , and trazodone ( p = 0.58 ) .
RESULTS	Fluvoxamine appears to be less effective than citalopram ( p = 0.036 ) , paroxetine ( p = 0.037 ) , clomipramine ( p = 0.05 ) , sertraline ( p = 0.011 ) , and duloxetine ( p = 0.024 ) .
CONCLUSIONS	Bupropion and fluvoxamine appear less effective in long-term treatment of MDD .
CONCLUSIONS	These results should be confirmed by randomized placebo-controlled prospective studies with larger samples .

###24506265
BACKGROUND	Open haemorrhoidectomy has been associated with considerable postoperative pain and discomfort .
BACKGROUND	Perianal intradermal injection of methylene blue has been shown to ablate perianal nerve endings and may bring about temporary pain relief after haemorrhoidectomy .
BACKGROUND	We hypothesized that the administration of intradermal methylene blue would reduce postoperative pain during the initial period after surgery .
METHODS	A randomized , prospective , single-blind placebo-controlled trial was conducted .
METHODS	Patients were randomized to intradermal injection at haemorrhoidectomy of either 4ml 1 % methylene blue and 16ml 0.5 % marcaine or of 16ml 0.5 % marcaine and 4ml saline prior to surgical dissection .
METHODS	Patients were asked to fill in a pain diary with a visual analogue scale .
METHODS	The primary outcome measure was pain score and analgesic use .
METHODS	Secondary outcomes were complications .
RESULTS	There were 37 patients in the methylene blue arm and 30 patients in the placebo arm .
RESULTS	There were no statistically significant differences in the sex , type of haemorrhoid , number of haemorrhoids excised , duration of surgery or hospital stay .
RESULTS	The mean pain scores were significantly lower and the use of paracetamol was also significantly less in the methylene blue group during the first three postoperative days .
RESULTS	The risk ratio of acute urinary retention occurring when methylene blue was not used was 2.320 ( 95 % CI 1.754-3 .067 ) .
RESULTS	Other complication rates were not significantly different .
CONCLUSIONS	Perianal intradermal injection of methylene blue was useful in reducing the initial postoperative pain of open haemorrhoidectomy .

###25509895
OBJECTIVE	To evaluate the efficacy of the combined drug furamag ( furasidine potassium and magnesium hydroxycarbonate ) in combination with the third-generation cephalosporin cefotaxime versus cephalosporin monotherapy for nosocomial urinary tract infections ( NUTI ) .
METHODS	The randomized open-label comparative parallel group clinical trial enrolled 52 male and female patients aged over 18 years with a documented diagnosis of NUTI .
METHODS	Group 1 ( a study group ) took oral furamag 300 mg/day in combination with intravenous cefotaxime 6 g/day ; Group 2 ( a control group ) received cefotaxime monotherapy .
METHODS	The duration of therapy in both groups was 7 to 10 days until the efficiency levels were achieved .
RESULTS	A final efficiency analysis was made in 24 and 25 patients from Groups 1 and 2 who had different forms of NUTI ( catheter-associated NUTI , cystitis , pyelonephritis ) .
RESULTS	On day 3 of treatment , most patients were noted to have a decreased systemic inflammatory response ; lower C-reactive protein and procalcitonin levels being in the study group patients .
RESULTS	The clinical efficiency of antibacterial therapy , which had been evaluated both immediately after treatment termination and during further control , did not substantially differ in the furamag/cefotaxime combination and control groups although there was an obvious tendency towards the more marked effect of combined therapy 7-14 days after treatment ( 11.8 % efficiency differences ; p > 0.05 ) .
RESULTS	Analysis of bacteriological efficacy revealed its most pronounced and clinically significant differences between the groups : the cefotaxime/furamag combination led to higher pathogen eradication in all follow-up periods : after 3 days of treatment ( 82.6 % ) and following a complete therapy cycle ( 95.8 % ) versus the cefotaxime monotherapy group ( 43.5 and 70.8 % , respectively ; p < 0.01 ) .
RESULTS	Microbiological results showed that the major NUTI pathogens ( Escherichia coli , enterococci ) were more susceptible to potassium furasidine ( furamag ) versus cefotaxime .
RESULTS	The in vitro higher activity of furamag versus cefotaxime was attended by the significantly higher eradication of one of the two important NUTI pathogens - Enterococcus faecalis .
CONCLUSIONS	Furamag used in combination with the third-generation cephalosporin cefotaxime showed a higher bacteriological efficacy and a rapider reduction in the symptoms of a systemic inflammatory response in patients with NUTI .
CONCLUSIONS	On the basis of the findings , the above combination of furamag and cefotaxime may be recommended as first-line therapy for NUTI when multidrug - resistant nosocomial infection pathogens are widely distributed now .

###24674576
OBJECTIVE	To examine myopic progression and factors connected with myopic progression .
METHODS	Myopic schoolchildren , with no previous spectacles , 119 boys and 121 girls , were recruited during 1983-1984 to a randomized 3-year clinical trial of bifocal treatment of myopia with a subsequent 20-year follow-up .
METHODS	Participants ' mean age at Baseline was 10.9 , ranging from 8.7 to 12.8 years .
METHODS	An ophthalmological examination was carried out annually for 3 years and twice thereafter at ca. 10-year intervals .
METHODS	Additional refraction values were received from prescriptions issued by different ophthalmologists and opticians .
METHODS	Altogether , 1915 refraction values were available .
METHODS	Reading distance and accommodation were measured at each control visit .
METHODS	Data on parents ' myopia , daily time spent on reading and close work , outdoor activities and watching television were gathered with a structured questionnaire .
RESULTS	Using bifocals ( +1.75 add ) or reading without glasses or accommodation stimulus during the 3-year period in childhood did not correlate with adulthood refraction .
RESULTS	Short reading distance in childhood predicted higher adulthood myopia among females .
RESULTS	The factors predicting faster myopic progression were parents ' myopia and less time spent on sports and outdoor activities at childhood .
RESULTS	Time spent on reading and close work in childhood was related to myopic progression during the first 3 years but did not predict adulthood myopia .
RESULTS	Myopia throughout follow-up was higher among those who watched television < 3 hr daily than those who spent more time watching television .
RESULTS	Mean myopic progression 8 years after age 20-24 was -0.45 D 0.71 ( SD ) , and in 45 % of cases , progression was 0.5 D.
CONCLUSIONS	In nearly half of the cases , myopia beginning at school continued to progress into adulthood .
CONCLUSIONS	Higher adulthood myopia was mainly related to parents ' myopia and less time spent on sports and outdoor activities in childhood .

###24237617
BACKGROUND	Mobile phone-based psychological interventions enable real time self-monitoring and self-management , and large-scale dissemination .
BACKGROUND	However , few studies have focussed on mild-to-moderate symptoms where public health need is greatest , and none have targeted work and social functioning .
BACKGROUND	This study reports outcomes of a CONSORT-compliant randomised controlled trial ( RCT ) to evaluate the efficacy of myCompass , a self-guided psychological treatment delivered via mobile phone and computer , designed to reduce mild-to-moderate depression , anxiety and stress , and improve work and social functioning .
METHODS	Community-based volunteers with mild-to-moderate depression , anxiety and/or stress ( N = 720 ) were randomly assigned to the myCompass program , an attention control intervention , or to a waitlist condition for seven weeks .
METHODS	The interventions were fully automated , without any human input or guidance .
METHODS	Participants ' symptoms and functioning were assessed at baseline , post-intervention and 3-month follow-up , using the Depression , Anxiety and Stress Scale and the Work and Social Adjustment Scale .
RESULTS	Retention rates at post-intervention and follow-up for the study sample were 72.1 % ( n = 449 ) and 48.6 % ( n = 350 ) respectively .
RESULTS	The myCompass group showed significantly greater improvement in symptoms of depression , anxiety and stress and in work and social functioning relative to both control conditions at the end of the 7-week intervention phase ( between-group effect sizes ranged from d = .22 to d = .55 based on the observed means ) .
RESULTS	Symptom scores remained at near normal levels at 3-month follow-up .
RESULTS	Participants in the attention control condition showed gradual symptom improvement during the post-intervention phase and their scores did not differ from the myCompass group at 3-month follow-up .
CONCLUSIONS	The myCompass program is an effective public health program , facilitating rapid improvements in symptoms and in work and social functioning for individuals with mild-to-moderate mental health problems .
BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN 12610000625077 .

###25716463
OBJECTIVE	The objective was to assess adverse outcomes in relation to the simplified Pulmonary Embolism Severity Index ( PESI ) score in patients treated with rivaroxaban or standard therapy in the phase III EINSTEIN PE study and to evaluate the utility of the simplified PESI score to identify low-risk pulmonary embolism ( PE ) patients .
METHODS	A post hoc analysis of EINSTEIN PE data was performed to assess the efficacy and safety of rivaroxaban in patients with a range of simplified PESI scores .
METHODS	Recurrent venous thromboembolism , fatal PE , all-cause mortality , and major bleeding were stratified by simplified PESI scores of 0 , 1 , or 2 and according to treatment period at 7 , 14 , 30 , and 90 days and at the end of the full intended treatment period .
RESULTS	Simplified PESI scores could be calculated in 4,831 of the 4,832 randomized patients ; of those , 53.6 , 36.7 , and 9.7 % had PESI scores of 0 , 1 , and 2 , respectively .
RESULTS	Among patients with simplified PESI scores of 0 or 1 , fatal PE , all-cause mortality , and other adverse outcomes were uncommon within the first 7 , 14 , and 30 days .
RESULTS	Patients with simplified PESI scores of 2 had more frequent adverse outcomes .
RESULTS	Major bleeding was lower in the rivaroxaban group , particularly in those with simplified PESI scores of 1 or 2 .
CONCLUSIONS	The findings support using risk stratification with the simplified PESI score to identify low-risk patients with PE .

###24412896
OBJECTIVE	This study compares moderators of initiation and maintenance of health behavior changes .
METHODS	Data come from a cluster-randomized , 12-month telephone counseling intervention for physical activity and diet , targeting type 2 diabetes or hypertension patients ( n = 434 , Australia,2005-2007 ) .
METHODS	Demographic and health-related characteristics , theoretical constructs , and baseline behavioral outcomes were considered as moderators .
METHODS	Mixed models , adjusting for baseline values , assessed moderation of intervention effects for trial outcomes ( physical activity , intakes of fat , saturated fat , fiber , fruit , vegetables ) at end-of-intervention ( 12 months/initiation ) and maintenance follow-up ( 18 months ) , and compared moderation between these periods .
RESULTS	Social support for physical activity and baseline physical activity were significant ( p < 0.05 ) moderators of physical activity at 12 months .
RESULTS	Gender , marital status , social support for healthy eating , BMI , and number of chronic conditions were significant moderators of dietary changes at 12 - and/or 18 months .
RESULTS	Instances of moderation differing significantly between 12 - and 18 months were : baseline physical activity for physical activity ( initiation ) and marital status for fat intake ( maintenance ) .
CONCLUSIONS	This exploratory study showed that moderation of physical activity and diet effects sometimes differed between initiation and maintenance .
CONCLUSIONS	To identify unique moderators for initiation and/or maintenance of behavior changes , future studies need to report on and statistically test for such differences .

###24552366
BACKGROUND	The role of a low glycemic index ( GI ) diet in the management of adolescent obesity remains controversial .
BACKGROUND	In this study , we aim to evaluate the impact of low GI diet versus a conventional Chinese diet on the body mass index ( BMI ) and other obesity indices of obese adolescents .
METHODS	Obese adolescents aged 15-18years were identified from population-recruited , territory-wide surveys .
METHODS	Obesity was defined as BMI 95th percentile of Hong Kong local age - and sex-specific references .
METHODS	Eligible subjects were randomized to either an intervention with low GI diet ( consisting of 45-50 % carbohydrate , 30-35 % fat and 15-20 % protein ) or conventional Chinese diet as control ( consisting of 55-60 % carbohydrate , 25-30 % fat and 10-15 % protein ) .
METHODS	We used random intercept mixed effects model to compare the differential changes across the time points from baseline to month 6 between the 2 groups .
RESULTS	104 obese adolescents were recruited ( 52 in low GI group and 52 in control group ; 43.3 % boys ) .
RESULTS	Mean age was 16.71.0 years and 16.8 1.0 years in low GI and control group respectively .
RESULTS	58.7 % subjects completed the study at 6months ( 65.4 % in low GI group and 51.9 % in control group ) .
RESULTS	After adjustment for age and sex , subjects in the low GI group had a significantly greater reduction in obesity indices including BMI , body weight and waist circumference ( WC ) compared to subjects in the control group ( all p < 0.05 ) .
RESULTS	After further adjustment for physical activity levels , WC was found to be significantly lower in the low GI group compared to the conventional group ( p = 0.018 ) .
CONCLUSIONS	Low GI diet in the context of a comprehensive lifestyle modification program may be an alternative to conventional diet in the management of obese adolescents .
BACKGROUND	ClinicalTrials.gov Ref .
BACKGROUND	No : NCT01278563 .

###24333089
BACKGROUND	The ( C ) ce ( s ) haplotype , mainly found in black individuals , contains two altered genes : a hybrid RHD-CE-D ( s ) gene segregated with a ce ( s ) allele of RHCE with two single nucleotide polymorphisms , c. 733C > G ( p.Leu245Val ) in exon 5 and c. 1006G > T ( Gly336Cys ) in exon 7 .
BACKGROUND	This haplotype could be responsible for false positive genotyping results in RhD-negative individuals and at a homozygous level lead to the loss of a high incidence antigen RH34 .
BACKGROUND	The aim of this study was to screen for the ( C ) ce ( s ) haplotype in Tunisian blood donors , given its clinico-biological importance .
METHODS	Blood samples were randomly collected from blood donors in the blood transfusion centre of Sousse ( Tunisia ) .
METHODS	A total of 356 RhD-positive and 44 RhD-negative samples were tested for the ( C ) ce ( s ) haplotype using two allele-specific primer polymerase chain reactions that detect c. 733C > G ( p.Leu245Val ) and c. 1006G > T ( p. Gly336Cys ) substitutions in exon 5 and 7 of the RHCE gene .
METHODS	In addition , the presence of the D-CE hybrid exon 3 was evaluated using a sequence-specific primer polymerase chain reaction .
RESULTS	Among the 400 individuals only five exhibited the ( C ) ce ( s ) haplotype in heterozygosity , for a frequency of 0.625 % .
RESULTS	On the basis of the allele-specific primer polymerase chain reaction results , the difference in ( C ) ce ( s ) haplotype frequency was not statistically significant between RhD-positive and RhD-negative blood donors .
CONCLUSIONS	These data showed the presence of the ( C ) ce ( s ) haplotype at a low frequency ( 0.625 % ) compared to that among Africans in whom it is common .
CONCLUSIONS	Nevertheless , the presence of RHD-CE-D ( s ) in Tunisians , even at a lower frequency , should be considered in the development of a molecular genotyping strategy for Rh genes , to ensure better management of the prevention of alloimmunisation .

###25582412
OBJECTIVE	To evaluate the effect of dry needling into a myofascial trigger point ( MTrP ) in the lower trapezius muscle of patients with mechanical idiopathic neck pain .
METHODS	A single-center , randomized , double-blinded controlled study .
METHODS	Patients were recruited from the student population of a local hospital by advertisement in the university clinic from January 2010 to December2011 .
METHODS	Patients ( N = 72 ) with unilateral neck pain , neck pain for 3 months , and active trigger points in the lower trapezius muscle were randomly assigned to 1 of 2 treatment groups .
METHODS	All the patients completed the study .
METHODS	Dry needling in an MTrP in the lower trapezius muscle , or dry needling in the lower trapezius muscle but not at an MTrP .
METHODS	The visual analog scale ( VAS ) , Neck Pain Questionnaire ( NPQ ) , and pressure-pain threshold ( PPT ) were assessed before the intervention and 1 week and 1 month postintervention .
RESULTS	Treatment with dry needling of the lower trapezius muscle close to the MTrP showed decreases in pain and PPT as well as an improvement in the degree of disability ( P < .001 ) compared with the baseline and control group measurements ( P < .001 ) .
RESULTS	The dry-needling technique performed in the MTrP showed more significant therapeutic effects ( P < .001 ) .
CONCLUSIONS	The application of dry needling into an active MTrP of the lower trapezius muscle induces significant changes in the VAS , NPQ , and PPT levels compared with the application of dry needling in other locations of the same muscle in patients with mechanical neck pain .

###25907176
OBJECTIVE	Assess the steady-state pharmacokinetics , pharmacodynamics and safety of once-daily ( q.d. ) versus twice-daily ( b.i.d. ) dosing with canagliflozin at the same total daily doses of 100 and 300 mg in healthy participants .
METHODS	34 participants ( 17 in each cohort ) were enrolled in this single-center , open-label , multiple-dose , 2-cohort , 2-way crossover study .
METHODS	Participants in each cohort received a total daily dose of either 100 or 300 mg canagliflozin for 5 days with q.d. then b.i.d. dosing or vice versa .
METHODS	Pharmacokinetics and pharmacodynamics were assessed on day 5 of each period .
RESULTS	The canagliflozin Cmax , ss of 100 and 300 mg q.d. dosing were higher by 66 % and 72 % than corresponding morning Cmax , ss of the 50 mg and 150 mg b.i.d. regimen , respectively .
RESULTS	The geometric mean ratios ( 90 % CI ) of b.i.d. / q.d. for AUC0-24h , ss at total doses of 100 and 300 mg were 97.08 ( 94.08 ; 99.62 ) and 99.32 ( 94.71 ; 104.16 ) respectively .
RESULTS	Median tmax and mean t1/2 were independent of dose and regimen .
RESULTS	Mean ( SE ) 24-h mean renal glucose threshold values for b.i.d. and q.d. regimens were 59.2 ( 1.03 ) and 60.2 ( 1.03 ) mg/dL for the 100 mg daily doses and 51.0 ( 1.04 ) and 52.5 ( 1.04 ) mg/dL for the 300 mg daily doses .
RESULTS	Mean ( SE ) values of 24-h urinary glucose excretion for b.i.d. and q.d. regimens were 52.8 ( 1.94 ) and 48.6 ( 1.94 ) g for the 100 mg daily doses and 58.6 ( 3.81 ) and 57.8 ( 3.81 ) g for the 300 mg daily doses .
RESULTS	Both doses were safe and well tolerated .
CONCLUSIONS	Pharmacokinetics and pharmacodynamics of canagliflozin administered q.d. relative to b.i.d. at the same 100 and 300 mg total daily doses were comparable .
CONCLUSIONS	Overall , canagliflozin was well tolerated .

###24482301
OBJECTIVE	Assess ustekinumab efficacy ( week 24/week 52 ) and safety ( week 16/week 24/week 60 ) in patients with active psoriatic arthritis ( PsA ) despite treatment with conventional and/or biological anti-tumour necrosis factor ( TNF ) agents .
METHODS	In this phase 3 , multicentre , placebo-controlled trial , 312 adults with active PsA were randomised ( stratified by site , weight ( 100 kg / > 100 kg ) , methotrexate use ) to ustekinumab 45 mg or 90 mg at week 0 , week 4 , q12 weeks or placebo at week 0 , week 4 , week 16 and crossover to ustekinumab 45 mg at week 24 , week 28 and week 40 .
METHODS	At week 16 , patients with < 5 % improvement in tender/swollen joint counts entered blinded early escape ( placebo45 mg , 45 mg90 mg , 90 mg90 mg ) .
METHODS	The primary endpoint was 20 % improvement in American College of Rheumatology ( ACR20 ) criteria at week 24 .
METHODS	Secondary endpoints included week 24 Health Assessment Questionnaire-Disability Index ( HAQ-DI ) improvement , ACR50 , ACR70 and 75 % improvement in Psoriasis Area and Severity Index ( PASI75 ) .
METHODS	Efficacy was assessed in all patients , anti-TNF-nave ( n = 132 ) patients and anti-TNF-experienced ( n = 180 ) patients .
RESULTS	More ustekinumab-treated ( 43.8 % combined ) than placebo-treated ( 20.2 % ) patients achieved ACR20 at week 24 ( p < 0.001 ) .
RESULTS	Significant treatment differences were observed for week 24 HAQ-DI improvement ( p < 0.001 ) , ACR50 ( p0 .05 ) and PASI75 ( p < 0.001 ) ; all benefits were sustained through week 52 .
RESULTS	Among patients previously treated with 1 TNF inhibitor , sustained ustekinumab efficacy was also observed ( week 24 combined vs placebo : ACR20 35.6 % vs 14.5 % , PASI75 47.1 % vs 2.0 % , median HAQ-DI change -0.13 vs 0.0 ; week 52 ustekinumab-treated : ACR20 38.9 % , PASI75 43.4 % , median HAQ-DI change -0.13 ) .
RESULTS	No unexpected adverse events were observed through week 60 .
CONCLUSIONS	The interleukin-12 / 23 inhibitor ustekinumab ( 45/90 mg q12 weeks ) yielded significant and sustained improvements in PsA signs/symptoms in a diverse population of patients with active PsA , including anti-TNF-experienced PsA patients .

###24606090
BACKGROUND	Progesterone vaginal insert ( PVI ) , an effervescent delivery system , dissolves rapidly , is absorbed through the vaginal epithelium , and achieves higher endometrial tissue concentrations than those achieved with progesterone in oil ( PIO ) given im .
OBJECTIVE	Our objective was to examine the pharmacokinetics and pharmacodynamics of PVI compared with PIO .
METHODS	Fifty-eight healthy premenopausal women were randomized to 50 , 100 , or 200 mg PVI once daily ; 100 or 200 mg PVI twice daily ; or 50 to 100 mg PIO via im injection once daily for 10 days .
METHODS	Serum samples were obtained after the first dose ; serum and endometrial tissue were obtained after the last dose .
METHODS	Maximum observed serum concentration ( Cmax ) , time to Cmax , and area under the serum-concentration time curve over the dosing interval were calculated after correcting for baseline progesterone concentrations .
METHODS	ANOVA and paired t test were used to compare results across and within groups .
RESULTS	A higher Cmax was observed after PIO than PVI administration .
RESULTS	Endometrial tissue progesterone concentrations were higher for PVI regimens .
RESULTS	Time to Cmax was 7.3 hours after PIO and 3.3 to 5.9 hours after PVI .
RESULTS	Steady state was achieved within 24 and 48 hours for PVI and PIO regimens , respectively .
RESULTS	The area under the curve increased with increasing PVI dosage ; however , the increase was not proportional to the increase in dosage .
RESULTS	Downregulation of estrogen and progesterone receptors was observed in secretory biopsy specimens .
CONCLUSIONS	The PVI system consistently allowed for rapid progesterone absorption and achieved higher endometrial tissue concentrations and lower systemic exposures than observed after im PIO .

###24592408
BACKGROUND	Pioglitazone is a thiazolidinedione ( TZD ) insulin sensitizer approved for use in human type 2 diabetes mellitus .
BACKGROUND	Therapeutic options for diabetes in cats are limited .
OBJECTIVE	To evaluate the effects of pioglitazone in obese cats , which are predisposed to insulin resistance , to assess its potential for future use in feline diabetes mellitus .
METHODS	A total of 12 obese purpose-bred research cats ( 6 neutered males and 6 spayed females , 5-7 years of age , weighing 5.4-9 .8 kg ) .
METHODS	Randomized , placebo-controlled 3-way crossover study .
METHODS	Oral placebo or pioglitazone ( Actos ; 1 or 3 mg/kg ) was administered daily for 7-week periods , with IV glucose tolerance testing before and after each period .
RESULTS	Three mg/kg pioglitazone significantly improved insulin sensitivity ( geometric mean [ 95 % CI ] 0.90 [ 0.64-1 .28 ] to 2.03 [ 1.49-2 .78 ] minpmolL ; P = .0014 versus change with placebo ) , reduced insulin area under the curve during IVGTT ( geometric mean [ range ] 27 [ 9-64 ] to 18 [ 6-54 ] minnmol/L ; P = .0031 versus change with placebo ) , and lowered serum triglyceride ( geometric mean [ range ] 71 [ 29-271 ] to 48 [ 27-75 ] mg/dL ; P = .047 versus change with placebo ) and cholesterol ( geometric mean [ range ] 187 [ 133-294 ] to 162 [ 107-249 ] mg/dL ; P = .0042 versus change with placebo ) concentrations in the obese cats .
RESULTS	No adverse effects attributable to pioglitazone were evident in the otherwise healthy obese cats at this dosage and duration .
CONCLUSIONS	Results of this study support a positive effect of pioglitazone on insulin sensitivity and lipid metabolism in obese cats , and suggest that further evaluation of the drug in cats with diabetes mellitus or other metabolic disorders might be warranted .

###24582567
OBJECTIVE	Nonalcoholic fatty liver disease ( NAFLD ) , characterized by accumulation of hepatic triglycerides ( steatosis ) , is associated with abdominal obesity , insulin resistance , and inflammation .
OBJECTIVE	Although weight loss via calorie restriction reduces features of NAFLD , there is no pharmacologic therapy .
OBJECTIVE	Resveratrol is a polyphenol that prevents high-energy diet-induced steatosis and insulin resistance in animals by up-regulating pathways that regulate energy metabolism .
OBJECTIVE	We performed a placebo-controlled trial to assess the effects of resveratrol in patients with NAFLD .
METHODS	Overweight or obese men diagnosed with NAFLD were recruited from hepatology outpatient clinics in Brisbane , Australia from 2011 through 2012 .
METHODS	They were randomly assigned to groups given 3000 mg resveratrol ( n = 10 ) or placebo ( n = 10 ) daily for 8 weeks .
METHODS	Outcomes included insulin resistance ( assessed by the euglycemic-hyperinsulinemic clamp ) , hepatic steatosis , and abdominal fat distribution ( assessed by magnetic resonance spectroscopy and imaging ) .
METHODS	Plasma markers of inflammation , as well as metabolic , hepatic , and antioxidant function , were measured ; transcription of target genes was measured in peripheral blood mononuclear cells .
METHODS	Resveratrol pharmacokinetics and safety were assessed .
RESULTS	Eight-week administration of resveratrol did not reduce insulin resistance , steatosis , or abdominal fat distribution when compared with baseline .
RESULTS	No change was observed in plasma lipids or antioxidant activity .
RESULTS	Levels of alanine and aspartate aminotransferases increased significantly among patients in the resveratrol group until week 6 when compared with the placebo group .
RESULTS	Resveratrol did not significantly alter transcription of NQO1 , PTP1B , IL6 , or HO1 in peripheral blood mononuclear cells .
RESULTS	Resveratrol was well-tolerated .
CONCLUSIONS	Eight weeks administration of resveratrol did not significantly improve any features of NAFLD , compared with placebo , but it increased hepatic stress , based on observed increases in levels of liver enzymes .
CONCLUSIONS	Further studies are needed to determine whether agents that are purported to mimic calorie restriction , such as resveratrol , are safe and effective for complications of obesity .
CONCLUSIONS	Clinical trials registration no : ACTRN12612001135808 .

###25714215
OBJECTIVE	To compare the efficacy of aspirin and warfarin for prophylaxis of thrombosis in patients undergoing total cavopulmonary anastomosis .
OBJECTIVE	Evaluate whether coagulation factors ( VII , VIII and protein C ) , clinical data , fenestration or hemodynamic factors , interfere with postoperative thrombosis .
METHODS	A prospective , randomized study of 30 patients , randomized into Group I ( Warfarin ) and Group II ( AAS ) , underwent total cavopulmonary shunt with extracardiac conduit , between 2008 and 2011 , with follow-up by clinical visits to evaluate side effects and adhesion .
METHODS	Performed transesophageal echocardiography in post operatory time , 3 , 6,12 and 24 months ; angiotomography at 6 , 12 and 24 months to evaluate changes in the internal tube wall or thrombi and pulmonary scintigraphy to evaluate possible PTE .
RESULTS	Two deaths in group I ; 33.3 % of patients had thrombus ( 46.7 % in Group II ) .
RESULTS	The previous occurrence of thrombus and low levels of coagulation protein C were the only factors that influenced the time free of thrombus ( P = 0.035 and 0.047 ) .
RESULTS	Angiotomographic evaluation : 35.7 % in group II presented material accumulation greater than 2 mm ( P = 0.082 ) .
RESULTS	Scintigraphy : two patients had PTE in group II .
RESULTS	Five patients had difficulty to comply with the treatment , 4 in group I with INR ranging from 1 to 6.4 .
CONCLUSIONS	The previous occurrence of thrombus is a risk factor for thrombosis in the postoperative period .
CONCLUSIONS	Patients using AAS tend to deposit material in the tube wall .
CONCLUSIONS	The small sample size did not allow to conclude which is the most effective drug in the prevention of thrombosis in this population .

###25605690
OBJECTIVE	This randomized trial investigated voice rest and supplemental text-to-speech communication versus voice rest alone on visual analog scale measures of communication effectiveness and magnitude of voice use .
METHODS	Randomized clinical trial .
METHODS	Multicenter outpatient voice clinics .
METHODS	Thirty-seven patients undergoing phonomicrosurgery .
METHODS	Patients undergoing phonomicrosurgery were randomized to voice rest and supplemental text-to-speech communication or voice rest alone .
METHODS	The primary outcome measure was the impact of voice rest on ability to communicate effectively over a 7-day period .
METHODS	Pre - and postoperative magnitude of voice use was also measured as an observational outcome .
RESULTS	Patients randomized to voice rest and supplemental text-to-speech communication reported higher median communication effectiveness on each postoperative day compared to those randomized to voice rest alone , with significantly higher median communication effectiveness on postoperative days 3 ( P = .03 ) and 5 ( P = .01 ) .
RESULTS	Magnitude of voice use did not differ on any preoperative ( P > .05 ) or postoperative day ( P > .05 ) , nor did patients significantly decrease voice use as the surgery date approached ( P > .05 ) .
RESULTS	However , there was a significant reduction in median voice use pre - to postoperatively across patients ( P < .001 ) with median voice use ranging from 0 to 3 throughout the postoperative week .
CONCLUSIONS	Supplemental text-to-speech communication increased patient-perceived communication effectiveness on postoperative days 3 and 5 over voice rest alone .
CONCLUSIONS	With the prevalence of smartphones and the widespread use of text messaging , supplemental text-to-speech communication may provide an accessible and cost-effective communication option for patients on vocal restrictions .

###25956366
OBJECTIVE	To assess anatomical and functional outcomes of a novel laparoscopic vaginoplasty technique using a single peritoneal flap ( SPF ) in patients with Mayer-Rokitansky-Kster-Hauser ( MRKH ) syndrome .
METHODS	Prospective follow-up study .
METHODS	University-based tertiary-care hospital .
METHODS	Patients with MRKH syndrome ( n = 83 ) and randomly selected frequency-matched age-comparable healthy women serving as controls ( n = 85 ) .
METHODS	From March 2004 to March 2014 , a total of 83 patients with MRKH syndrome underwent laparoscopic vaginoplasty using an SPF .
METHODS	Intraoperative parameters , postoperative parameters , and anatomical outcomes were recorded .
METHODS	The functional results of patients who became sexually active were assessed using the Female Sexual Function Index ( FSFI ) questionnaire and were compared with those of the controls .
RESULTS	Laparoscopic vaginoplasty using an SPF was successfully performed in all 83 patients , with no intraoperative complications .
RESULTS	The mean operative time and intraoperative blood loss were , respectively , 71.2 18.9 minutes and 88.5 57.2 ml .
RESULTS	The mean length and width of the neovagina at the 6-month follow-up examination were , respectively , 8.2 0.8 cm and 3.0 0.6 cm .
RESULTS	Anatomical success was achieved in all patients .
RESULTS	At 12months after surgery , functional success , as assessed by the FSFI questionnaire , was achieved in 95.3 % of patients .
RESULTS	The FSFI scores did not differ significantly between patients with MRKH and healthy women in a control group .
CONCLUSIONS	Laparoscopic vaginoplasty using an SPF may be a feasible and effective approach that has satisfactory anatomical and functional outcomes for patients with MRKH syndrome .

###24963611
BACKGROUND	Failure to achieve treatment targets is common among people with type 2 diabetes .
BACKGROUND	Cost-effective treatments are required to delay the onset and slow the progression of diabetes-related complications .
OBJECTIVE	This study aimed to measure the effect of a 6-month telephone coaching intervention on glycaemic control , risk factor status and adherence to diabetes management practices at the intervention 's conclusion ( 6 months ) and at 12 months .
METHODS	This randomised controlled trial recruited 94 adults with type 2 diabetes and an HbA1C > 7 % from the Diabetes Clinic of St Vincent 's Hospital Melbourne .
METHODS	People who were non-English speaking , cognitively impaired , severely hearing impaired or without telephone access were excluded .
METHODS	Participants were randomised to receive usual care plus 6 months of telephone coaching focusing on achieving treatment targets and complication screening , or usual care only .
METHODS	The primary outcome was HbA1C at 6 months ; secondary outcomes included other physiological and monitoring measures .
RESULTS	Significant interaction effects were observed between group and time at 6 months , demonstrating improvement in HbA1C , fasting glucose , diastolic blood pressure and physical activity .
RESULTS	The intervention 's effect on these parameters was not sustained at 12 months .
RESULTS	Intervention group participants also improved compliance with foot examinations and pneumococcal vaccination by 6 months and retinal screening by 12 months .
CONCLUSIONS	Telephone coaching improved glycaemic control and adherence to complication screening in people with type 2 diabetes , for the duration of its delivery , but these effects were not maintained on withdrawal of the intervention .
CONCLUSIONS	Strategies that assist patients to sustain these benefits are required .

###24910929
OBJECTIVE	To compare performance error and perceived difficulty during toe-out gait modification in people with knee osteoarthritis ( OA ) across 3 different types of visual feedback : mirror , raw video , and real-time biofeedback of toe-out angle .
METHODS	Repeated-measures , within-subject trial .
METHODS	University motion analysis laboratory .
METHODS	Individuals with knee OA ( N = 20 ; 11 women ; mean age , 65.49.8 y ) participated in this study .
METHODS	Seven participants had mild knee OA , 9 had moderate knee OA , and 4 had severe knee OA .
METHODS	Participants were trained to walk on a treadmill while matching a target indicating a 10 increase in stance phase toe-out compared with toe-out angle measured during self-selected walking .
METHODS	The target was provided visually via the 3 types of feedback listed above and were presented in a random order .
METHODS	Kinematic data were collected and used to calculate the difference between the target angle and the actual performed angle for each condition ( toe-out performance error ) .
METHODS	Difficulty was assessed using a numerical rating scale ( 0-10 ) provided verbally by participants .
RESULTS	Toe-out performance error was significantly less when using the real-time biofeedback method than when using the other 2 methods ( P = .025 ; mean difference vs mirror = 2.05 ; mean difference vs raw video = 1.51 ) .
RESULTS	Perceived difficulty was not statistically different between the groups ( P = .51 ) .
CONCLUSIONS	Although statistically significant , the 2 difference in toe-out gait performance error may not necessitate the large economic and personnel costs of real-time biofeedback as a means to modify movement in clinical or research settings .

###24457205
BACKGROUND	The prevalence of male obesity is increasing but few men take part in weight loss programmes .
BACKGROUND	We assessed the effect of a weight loss and healthy living programme on weight loss in football ( soccer ) fans .
METHODS	We did a two-group , pragmatic , randomised controlled trial of 747 male football fans aged 35-65 years with a body-mass index ( BMI ) of 28 kg/m ( 2 ) or higher from 13 Scottish professional football clubs .
METHODS	Participants were randomly assigned with SAS ( version 92 , block size 2-9 ) in a 1:1 ratio , stratified by club , to a weight loss programme delivered by community coaching staff in 12 sessions held every week .
METHODS	The intervention group started a weight loss programme within 3 weeks , and the comparison group were put on a 12 month waiting list .
METHODS	All participants received a weight management booklet .
METHODS	Primary outcome was mean difference in weight loss between groups at 12 months , expressed as absolute weight and a percentage of their baseline weight .
METHODS	Primary outcome assessment was masked .
METHODS	Analyses were based on intention to treat .
METHODS	The trial is registered with Current Controlled Trials , number ISRCTN32677491 .
RESULTS	374 men were allocated to the intervention group and 374 to the comparison group .
RESULTS	333 ( 89 % ) of the intervention group and 355 ( 95 % ) of the comparison group completed 12 month assessments .
RESULTS	At 12 months the mean difference in weight loss between groups , adjusted for baseline weight and club , was 494 kg ( 95 % CI 395-594 ) and percentage weight loss , similarly adjusted , was 436 % ( 364-508 ) , both in favour of the intervention ( p < 00001 ) .
RESULTS	Eight serious adverse events were reported , five in the intervention group ( lost consciousness due to drugs for pre-existing angina , gallbladder removal , hospital admission with suspected heart attack , ruptured gut , and ruptured Achilles tendon ) and three in the comparison group ( transient ischaemic attack , and two deaths ) .
RESULTS	Of these , two adverse events were reported as related to participation in the programme ( gallbladder removal and ruptured Achilles tendon ) .
CONCLUSIONS	The FFIT programme can help a large proportion of men to lose a clinically important amount of weight ; it offers one effective strategy to challenge male obesity .
BACKGROUND	Scottish Government and The UK Football Pools funded delivery of the programme through a grant to the Scottish Premier League Trust .
BACKGROUND	The National Institute for Health Research Public Health Research Programme funded the assessment ( 09/3010/06 ) .

###25168268
BACKGROUND	The objective of this study was to evaluate the long-term safety and efficacy of tabalumab , a monoclonal antibody that neutralizes membrane-bound and soluble B-cell-activating factor , in rheumatoid arthritis ( RA ) patients .
METHODS	Patients with RA who completed one of two 24-week randomized controlled trials ( RCTs ) participated in this 52-week , flexible-dose , open-label extension study .
METHODS	Patients in RCT1 received intravenous placebo , 30-mg tabalumab or 80-mg tabalumab every 3weeks , and patients in RCT2 received subcutaneous placebo or 1 - , 3 - , 10 - , 30 - , 60 - or 120-mg tabalumab every 4weeks ( Q4W ) .
METHODS	Regardless of prior treatment , all patients in this study received subcutaneous 60-mg tabalumab Q4W for the first 3months , then a one-time increase to 120-mg tabalumab Q4W ( 60-mg/120-mg group ) and a one-time decrease to 60-mg tabalumab Q4W per patient was allowed ( 60-mg/120-mg/60-mg group ) .
RESULTS	There were 182 patients enrolled : 60mg ( n = 60 ) , 60/120mg ( n = 121 ) and 60/120/60mg ( n = 1 ) .
RESULTS	Pretabalumab baseline disease activity was generally higher in the 60-mg/120-mg group .
RESULTS	There was a higher frequency of serious adverse events and treatment-emergent adverse events , as well as infections and injection-site reactions , in the 60-mg/120-mg group .
RESULTS	One death unrelated to the study drug occurred ( 60-mg/120-mg group ) .
RESULTS	In both groups , total B-cell counts decreased by approximately 40 % from the baseline level in the RCT originating study .
RESULTS	Both groups demonstrated efficacy through 52weeks of treatment relative to baseline pretabalumab disease activity based on American College of Rheumatology criteria improvement 20 % , 50 % and 70 % ; European League against Rheumatism Responder Index in 28 joints ; Disease Activity Score in 28 joints-C-reactive protein ; and Health Assessment Questionnaire-Disability Index .
CONCLUSIONS	With long-term , open-label tabalumab treatment , no unexpected safety signals were observed , and B-cell reductions were consistent with previous findings .
CONCLUSIONS	Despite differences in RCT originating studies , both groups demonstrated an efficacy response through the 52-week extension .
BACKGROUND	ClinicalTrials.gov Identifier : NCT00837811 ( registered 3 February 2009 ) .

###24506194
BACKGROUND	Trigeminal nerve block is widely used for trigeminal neuralgia ( TN ) , though with much painful procedure and potential serious complications .
BACKGROUND	The pain of TN occurs most frequently in the second and the third divisions of the trigeminal nerve , which are distributed in intraoral mucous membrane as well as face skin .
BACKGROUND	Here , we examined the response to intraoral application of 8 % lidocaine ( LDC ) in patients with oral TN pain in a double-blind , placebo ( PBO ) - controlled crossover study .
METHODS	Twenty-four outpatients with oral TN pain were randomized to receive intraoral application of either 8 % LDC or saline PBO to the painful area .
METHODS	Following 7-days period , patients were crossed over to receive the alternative treatment .
METHODS	The pain was assessed with a numerical rating scale ( NRS ) before and 15 minutes after treatment .
METHODS	Patients used a descriptive scale to grade pain outcome and were asked to note any recurrence and the latency for recurrence after therapy .
RESULTS	Intraoral LDC , but not PBO , significantly decreased the NRS from 5 ( 4 , 8 ) ( median [ 25 , 75 percentiles ] ) to 1 ( 0 , 4 ) ( P = 0.001 ) .
RESULTS	Of the 24 patients , 19 described marked or moderate relief of pain after LDC but only three described the same after PBO application .
RESULTS	The effect of LDC and PBO persisted for 2.8 ( 0.3 , 3.0 ) and 0 ( 0 , 0 ) hours , respectively .
CONCLUSIONS	Intraoral application of 8 % LDC produced prompt analgesia without serious side effects in patients with TN who presented with severe intraoral pain .

###24555418
BACKGROUND	Knee osteoarthritis ( OA ) is a common and disabling condition .
BACKGROUND	Abnormalities in knee loading play an important role in disease pathogenesis , yet there are few non-surgical treatments for knee OA capable of reducing knee load .
BACKGROUND	This two-arm randomised controlled trial is investigating the efficacy of specially-designed unloading shoes for the treatment of symptoms in people with knee OA .
METHODS	164 people with symptomatic medial tibiofemoral joint OA will be recruited from the community and randomly allocated to receive either unloading shoes or control shoes .
METHODS	Unloading shoes have a specially-designed triple-density midsole where the medial side is softer than normal and the lateral side harder as well as a lateral wedge between the sole and sock-liner .
METHODS	Control shoes are standard athletic shoes and do not contain these features .
METHODS	Participants will be blinded to shoe allocation and will be instructed to wear the shoes as much as possible every day for 6 months , for a minimum of 4 hours per day .
METHODS	The primary outcomes are knee pain ( numerical rating scale ) and self-reported physical function ( Western Ontario and McMaster Universities Osteoarthritis Index ) measured at baseline and 6 months .
METHODS	Secondary outcomes include additional measures of knee pain , knee stiffness , participant global ratings of change in symptoms , quality-of-life and physical activity .
CONCLUSIONS	The findings from this study will help determine whether specially-designed unloading shoes are efficacious in the management of knee OA .
BACKGROUND	Australian New Zealand Clinical Trials Registry reference : ACTRN12613000851763 .

###24646068
BACKGROUND	Tonsillectomy is one of the most common pediatric procedures in the United States .
BACKGROUND	An optimal perioperative pain control regimen remains a challenge .
BACKGROUND	Intravenous ibuprofen administered at induction of anesthesia may be a safe and efficacious option for postoperative tonsillectomy pain .
OBJECTIVE	To determine whether preoperative administration of intravenous ibuprofen ( IV-ibuprofen ) can significantly decrease the number of doses of postoperative fentanyl when compared with placebo in pediatric tonsillectomy surgical patients .
METHODS	This was a multicenter , randomized , double-blind placebo-controlled trial conducted at six hospitals in the United States .
METHODS	A total of 161 pediatric patients aged 6-17 years undergoing tonsillectomy were randomized to receive either a single preoperative dose of 10 mgkg ( -1 ) IV-ibuprofen or placebo ( normal saline ) .
METHODS	Postoperative pain was managed with intravenous fentanyl ( 0.5 gkg ( -1 ) ) on an as needed basis when the visual analog scale ( VAS ) was > 30 mm and deemed appropriate by recovery room nurse/physician .
METHODS	The primary endpoint was the number of doses and amount of postoperative fentanyl administered postoperatively for rescue analgesia .
RESULTS	There was a significant reduction in the number of postoperative doses and the amount of fentanyl administered after surgery in the IV-ibuprofen group compared with the placebo group ( P = 0.021 ) .
RESULTS	There were no differences in the time to first analgesia request or the number of patients who required postoperative analgesia .
RESULTS	There were no significant differences in the incidence of serious adverse events , surgical blood loss ( P = 0.662 ) , incidence of postoperative bleeding , or a need for surgical re-exploration between the treatment groups .
CONCLUSIONS	Administration of IV-ibuprofen , 10 mgkg ( -1 ) , significantly reduced fentanyl use in pediatric tonsillectomy patients .

###24763155
OBJECTIVE	The objective of this study is to compare the effects of mindfulness-based stress reduction ( MBSR ) versus yoga on urinary urge incontinence ( UI ) at 8 weeks , 6 months , and 1 year after beginning an 8-week program .
METHODS	Participants in this prospective randomized single-masked pilot study were women aged 18 years or older with urge-predominant incontinence , 5 or more UI episodes ( UIEs ) on a 3-day voiding diary , and no recent anticholinergic use .
METHODS	Women were randomized to MBSR or yoga .
METHODS	The primary outcome was the percent change of UIE .
RESULTS	Of 30 enrollees ( 15 in MBSR , 15 in yoga ) , 24 completed at least 5 of 8 sessions ( 13 in MBSR and 11 in yoga ) .
RESULTS	Twenty and 21 women completed the 6-month and 12-month follow-up visits , respectively .
RESULTS	At 8 weeks , 6 months , and 12 months , the median percent change from the baseline in UIE on the intention-to-treat analysis was greater for the MBSR group ( -55.6 , -71.4 , and -66.7 , respectively ) compared with that for the yoga group ( -33.3 , -11.8 , and -16.7 , respectively ) , with P values ranging from 0.01 to 0.08 .
RESULTS	On intention-to-treat analysis , the median percent change in the Overactive Bladder Symptom and Quality of Life-Short Form and the Health-Related Quality of Life was greater at each time point for MBSR than for yoga but was statistically significant only at 8 weeks ( P = 0.003 and 0.02 , respectively ) .
RESULTS	As per protocol analysis , at 8 weeks , 6/13 and 0/11 women in MBSR and yoga , respectively , reported they were very much or much better ( P = 0.02 ) , whereas at 1 year , 6/12 and 1/9 women in MBSR and yoga , respectively , did so ( P = 0.16 ) .
CONCLUSIONS	These results support larger scale trials to evaluate MBSR , which seems to be a promising treatment of UI .

###24495599
BACKGROUND	Mental health patients can feel anxious about losing the support of staff and patients when discharged from hospital and often discontinue treatment , experience relapse and readmission to hospital , and sometimes attempt suicide .
BACKGROUND	The benefits of peer support in mental health services have been identified in a number of studies with some suggesting clinical and economic gains in patients being discharged .
METHODS	This pilot randomised controlled trial with economic evaluation aimed to explore whether peer support in addition to usual aftercare for patients during the transition from hospital to home would increase hope , reduce loneliness , improve quality of life and show cost effectiveness compared with patients receiving usual aftercare only , with follow-up at one and three-months post-discharge .
RESULTS	A total of 46 service users were recruited to the study ; 23 receiving peer support and 23 in the care-as-usual arm .
RESULTS	While this pilot trial found no statistically significant benefits for peer support on the primary or secondary outcome measures , there is an indication that hope may be further increased in those in receipt of peer support .
RESULTS	The total cost per case for the peer support arm of the study was 2154 compared to 1922 for the control arm .
RESULTS	The mean difference between costs was minimal and not statistically significant .
RESULTS	However , further analyses demonstrated that peer support has a reasonably high probability of being more cost effective for a modest positive change in the measure of hopelessness .
RESULTS	Challenges faced in recruitment and follow-up are explored alongside limitations in the delivery of peer support .
CONCLUSIONS	The findings suggest there is merit in conducting further research on peer support in the transition from hospital to home consideration should be applied to the nature of the patient population to whom support is offered ; the length and frequency of support provided ; and the contact between peer supporters and mental health staff .
CONCLUSIONS	There is no conclusive evidence to support the cost effectiveness of providing peer support , but neither was it proven a costly intervention to deliver .
CONCLUSIONS	The findings support an argument for a larger scale trial of peer support as an adjunct to existing services .
BACKGROUND	Current Controlled Trials ISRCTN74852771 .

###25403211
OBJECTIVE	To assess the effectiveness of a telephone-based peer-delivered intervention in reducing distress among women with a BRCA1 or BRCA2 gene mutation .
OBJECTIVE	The intervention involved trained peer volunteers contacting women multiple times over a 4-month period to provide informational , emotional , and practical support .
METHODS	Three hundred thirty-seven participants completed the baseline questionnaire , and those reporting interest in talking to other mutation carriers were randomly assigned to either the usual care group ( UCG ; n = 102 ) or the intervention group ( IG ; n = 105 ) .
METHODS	Participants and researchers were not blinded to group allocation .
METHODS	Two follow-up questionnaires were completed , one at the end of the intervention ( 4 months after random assignment , time 2 ) and one 2 months later ( time 3 ) .
METHODS	Outcomes included breast cancer distress ( primary outcome ) , unmet information needs , cognitive appraisals about mutation testing , and feelings of isolation .
RESULTS	There was a greater decrease in breast cancer distress scores in the IG than UCG at time 2 ( mean difference , -5.96 ; 95 % CI , -9.80 to -2.12 ; P = .002 ) and time 3 ( mean difference , -3.94 ; 95 % CI , -7.70 to -0.17 ; P = .04 ) .
RESULTS	There was a greater reduction in unmet information needs in the IG than UCG ( P < .01 ) , with unmet needs being lower in the IG than UCG at time 2 .
RESULTS	There was a greater reduction in Cognitive Appraisals About Genetic Testing stress subscale scores in the IG than UCG ( P = .02 ) , with significantly lower scores among the IG than UCG at time 2 ( P < .01 ) .
CONCLUSIONS	The intervention is effective in reducing distress and unmet information needs for this group of women .
CONCLUSIONS	Identifying strategies for prolonging intervention effects is warranted .

###25338053
OBJECTIVE	To evaluate the effects of a low-sodium and high-potassium salt-substitute on lowering blood pressure ( BP ) among Tibetans living at high altitude ( 4300 meters ) .
METHODS	The study was a patient-blinded randomized controlled trial conducted between February and May 2009 in Dangxiong County , Tibetan Autonomous Region , China .
METHODS	A total of 282 Tibetans aged 40 or older with known hypertension ( systolic BP140 mmHg ) were recruited and randomized to intervention ( salt-substitute , 65 % sodium chloride , 25 % potassium chloride and 10 % magnesium sulfate ) or control ( 100 % sodium chloride ) in a 1 : 1 allocation ratio with three months ' supply .
METHODS	Primary outcome was defined as the change in BP levels measured from baseline to followed-up with an automated sphygmomanometer .
METHODS	Per protocol ( PP ) and intention to treat ( ITT ) analyses were conducted .
RESULTS	After the three months ' intervention period , the net reduction in SBP/DBP in the intervention group in comparison to the control group was -8.2 / -3.4 mmHg ( all p < 0.05 ) in PP analysis , after adjusting for baseline BP and other variables .
RESULTS	ITT analysis showed the net reduction in SBP/DBP at -7.6 / -3.5 mmHg with multiple imputations ( all p < 0.05 ) .
RESULTS	Furthermore , the whole distribution of blood pressure showed an overall decline in SBP/DBP and the proportion of patients with BP under control ( SBP/DBP < 140 mmHg ) was significantly higher in salt-substitute group in comparison to the regular salt group ( 19.2 % vs. 8.8 % , p = 0.027 ) .
CONCLUSIONS	Low sodium high potassium salt-substitute is effective in lowering both systolic and diastolic blood pressure and offers a simple , low-cost approach for hypertension control among Tibetans in China .
BACKGROUND	ClinicalTrials.gov NCT01429246 .

###25727583
OBJECTIVE	To determine the sensitivity and specificity of the Web-based vision-screening test ( WBT ) VisionForKids.org when administered by an untrained layperson in a controlled environment .
METHODS	Visual acuities were obtained by an untrained layperson using the WBT under observation and by an ophthalmic professional using the Electronic Visual Acuity ( EVA ) Tester .
METHODS	Subjects were randomized to which method was used first .
METHODS	Subjects were considered to have failed by the following criteria : in children < 48 months , 20/50 vision ; in children between 48 and 59 months , 20/40 or worse ; in children 60 months , 20/30 or worse .
METHODS	The results of the vision examinations by the WBT and the EVA Tester were compared ; sensitivity and specificity of the WBT and the correlation coefficient to detect normal and abnormal vision compared to EVA testing were determined .
RESULTS	Visual acuities were obtained on 203 children between ages 3 and 12 years ( average age , 7.4 years ) .
RESULTS	Sensitivity of the WBT was 78.7 % ( 95 % CI , 66.0 % -87.7 % ) , specificity was 89.4 % ( 95 % CI , 82.9 % -93.8 % ) .
RESULTS	The correlation coefficient of EVA testing with the WBT was 0.89 ( P < 0.001 ) .
CONCLUSIONS	This layperson-administered WBT , VisionForKids.org , is valid for identifying amblyopia in a controlled environment , making it possible for cost-effective and easily accessible vision screening to be performed by laypersons .

###25042212
BACKGROUND	Few studies have examined why smoking cessation interventions are effective .
BACKGROUND	The aim of this study was to examine the mediating processes underlying the effectiveness of cessation counseling administered by the Dutch national quitline .
METHODS	Data were used of a two-arm randomized controlled trial in which smoking parents , who were recruited through primary schools in The Netherlands , received either quitline cessation counseling ( n = 256 ) or a self-help brochure ( n = 256 ) .
METHODS	The endpoint was 6-months prolonged abstinence at 12-months follow-up , with 86.7 % outcome data retention .
METHODS	Putative psychological mediators of treatment effectiveness included smoking-related cognitions ( positive smoking outcome expectancies , self-efficacy ) , emotions ( negative affect , perceived stress , depressive symptoms ) , and smoking cue coping methods ( avoidance coping , acceptance coping ) assessed at 3-months post-measurement .
RESULTS	Quitline cessation counseling significantly decreased positive smoking outcome expectancies and negative affect and increased self-efficacy to refrain from smoking , avoidance of external cues to smoking , and acceptance of internal cues to smoking compared to self-help material .
RESULTS	Increased self-efficacy to refrain from smoking in stressful and tempting situations ( p < .001 ) and increased acceptance of cravings to smoke ( p < .001 ) significantly mediated the effect of quitline cessation counseling on prolonged abstinence at 12-months follow-up ( explained variance : 25.1 % ) .
CONCLUSIONS	Self-efficacy to refrain from smoking and acceptance of cravings represent an important source of therapeutic change in smoking cessation counseling .

###24500308
BACKGROUND	In this Phase 4 international study , efficacy and safety of paricalcitol-centred therapy were compared with that of cinacalcet-centred therapy for the treatment of chronic kidney disease ( CKD ) - associated secondary hyperparathyroidism ( SHPT ) in patients undergoing haemodialysis ( ClinicalTrials.gov identifier NCT00977080 ) .
METHODS	Patients 18 years of age with Stage 5 CKD and SHPT [ intact parathyroid hormone ( iPTH ) level of 300-800 pg/mL , calcium level of 8.4-10 .0 mg/dL and phosphate concentration of 6.5 mg/dL ] who were undergoing haemodialysis were included .
METHODS	Patients were randomized by mode of paricalcitol administration [ i.e. intravenous ( IV ) or oral strata ] to receive paricalcitol - or cinacalcet-centred therapy for 28 weeks .
METHODS	Changes in metabolic markers [ total alkaline phosphatase ( AP ) , bone-specific AP and fibroblast growth factor-23 ( FGF-23 ) ] and the proportion of patients in each treatment group who achieved an iPTH level of 150-300 pg/mL during Weeks 8 , 16 and 21-28 as a composite value were evaluated .
RESULTS	Compared with cinacalcet-centred therapy , levels of both bone turnover markers were significantly reduced from baseline with IV and oral paricalcitol-centred treatment ( P < 0.05 for both dosing strata ) at Weeks 8 , 16 and 28 .
RESULTS	Levels of FGF-23 were increased with paricalcitol versus cinacalcet-centred treatment .
RESULTS	A greater proportion of patients receiving paricalcitol-centred therapy achieved target iPTH levels ( i.e. 150-300 pg/mL ) throughout the study in the IV and oral dosing strata compared with patients receiving cinacalcet-centred treatment .
CONCLUSIONS	In patients with CKD and SHPT undergoing haemodialysis , paricalcitol-centred therapy reduced circulating bone turnover markers and iPTH levels and increased FGF-23 levels compared with cinacalcet-centred treatment .
BACKGROUND	ClinicalTrials.gov identifier NCT00977080 .

###24676204
BACKGROUND	The immunological bases for the efficacies of the 2 currently licensed influenza vaccines , live attenuated influenza vaccine ( LAIV ) and inactivated influenza vaccine ( IIV ) , are not fully understood .
BACKGROUND	The goal of this study was to identify specific B-cell responses correlated with the known efficacies of these 2 vaccines .
METHODS	We compared the B-cell and antibody responses after immunization with 2010/2011 IIV or LAIV in young adults , focusing on peripheral plasmablasts 6-8 days after vaccination .
RESULTS	The quantities of vaccine-specific plasmablasts and plasmablast-derived polyclonal antibodies ( PPAbs ) in IIV recipients were significantly higher than those in LAIV recipients .
RESULTS	No significant difference was detected in the avidity of vaccine-specific PPAbs between the 2 vaccine groups .
RESULTS	Proportionally , LAIV induced a greater vaccine-specific immunoglobulin A plasmablast response , as well as a greater plasmablast response to the conserved influenza nuclear protein , than IIV .
RESULTS	The cross-reactive plasmablast response to heterovariant strains , as indicated by the relative levels of cross-reactive plasmablasts and the cross-reactive PPAb binding reactivity , was also greater in the LAIV group .
CONCLUSIONS	Distinct quantitative and qualitative patterns of plasmablast responses were induced by LAIV and IIV in young adults ; a proportionally greater cross-reactive response was induced by LAIV .

###25367551
OBJECTIVE	This study was designed to investigate whether a priming dose of ketamine-dexmedetomidine can effectively suppress fentanyl-induced coughing ( FIC ) .
METHODS	Altogether 400 patients of ASA I and II , aged 18-70 years , undergoing various elective surgical procedures , were randomly allocated into four groups of 100 patients each .
METHODS	Patients in the placebo group received volume-matched normal saline 0.15 mL/kg + normal saline 0.05 mL/kg .
METHODS	One group of patients was given ketamine 0.15 mg/kg + normal saline 0.05 ml/kg ( KET ) , and another group dexmedetomidine 0.5 g/kg + normal saline 0.05 ml/kg ( DEX ) .
METHODS	Finally , one group of patients received ketamine 0.15 mg/kg + dexmedetomidine 0.5 g/kg ( KETODEX ) .
METHODS	After fentanyl administration , the onset time and severity of cough for 1 min were recorded .
METHODS	Cough severity was graded as mild ( grade 1-2 ) , moderate ( grade 3-5 ) , or severe ( grade > 5 ) .
RESULTS	The incidence of FIC was 53 % , 34 % , 20 % , and 9 % in the placebo , DEX , KET , and KETODEX groups , respectively .
RESULTS	The incidence of cough was significantly lower in the KETODEX group .
RESULTS	Likewise , the onset time of cough was significantly delayed in the KETODEX group .
RESULTS	Only nine patients in the KETODEX group had either mild ( 6 % ) or moderate ( 3 % ) cough , with none suffering from severe cough .
CONCLUSIONS	A priming dose of KETODEX effectively suppressed the cough reflex induced by fentanyl and delayed the onset time of cough .
CONCLUSIONS	Therefore , treatment with KETODEX may be a clinically useful method for preventing FIC .

###24942282
BACKGROUND	The provision of quality end-of-life care is increasingly on the national agenda in many countries .
BACKGROUND	In the United Kingdom , the Gold Standards Framework for Care Homes programme has been promoted as a national framework for improving end-of-life care .
BACKGROUND	While its implementation is recommended , there are no national guidelines for facilitators to follow to undertake this role .
OBJECTIVE	It was hypothesised that action learning alongside high facilitation when implementing the Gold Standards Framework for Care Homes programme will result in a reduced proportion of hospital deaths for residents and improvement in the care home staff ability to facilitate good end-of-life care .
METHODS	A cluster randomised controlled trial where 24 nursing homes received high facilitation to enable them to implement the Gold Standards Framework for Care Homes programme .
METHODS	The managers of 12 nursing homes additionally took part in action learning sets .
METHODS	A third group ( 14 nursing homes ) received the ` standard ' Gold Standards Framework for Care Homes facilitation available in their locality .
METHODS	In total , 38 nursing homes providing care for frail older people , their deceased residents and their nurse managers .
RESULTS	A greater proportion of residents died in those nursing homes receiving high facilitation and action learning but not significantly so .
RESULTS	There was a significant association between the level of facilitation and nursing homes completing the Gold Standards Framework for Care Homes programme through to accreditation .
RESULTS	Year-on-year change occurred across all outcome measures .
CONCLUSIONS	There is a danger that without national guidelines , facilitation of the Gold Standards Framework for Care Homes programme will vary and consequently so will its implementation .
CONCLUSIONS	The nurse manager of a care home must be actively engaged when implementing the Gold Standards Framework for Care Homes programme .

###25300977
BACKGROUND	The Effect of Cilostazol in Acute Lacunar Infarction Based on Pulsatility Index of the Transcranial Doppler ( ECLIPse ) study showed a significant decrease in the transcranial Doppler ( TCD ) pulsatility index ( PI ) with cilostazol treatment at 90 days after acute lacunar infarction .
BACKGROUND	The aim of the present study was to perform a subgroup analysis of the ECLIPse study in order to explore the effect of cilostazol in acute lacunar infarction based on cerebral white matter hyperintensities ( WMH ) volume .
METHODS	The ECLIPse study was a multicenter , randomized , double-blind , placebo-controlled trial that evaluated the difference between the efficacy of cilostazol and a placebo to reduce the PI in patients with acute lacunar infarction using serial TCD examinations .
METHODS	The primary outcome was changes in the PIs of the middle cerebral artery ( MCA ) and basilar artery at 14 and 90 days from the baseline TCD study .
METHODS	For this subgroup analysis , using semi-automated computerized software , the WMH volume was measured for those subjects for whom fluid-attenuated inversion recovery ( FLAIR ) images were available .
RESULTS	Of the 203 patients in eight hospitals in the ECLIPse study , 130 participants from six hospitals were included in this subgroup analysis .
RESULTS	Cilostazol was given to 63 patients ( 48.5 % ) and placebo to 67 patients ( 51.5 % ) .
RESULTS	All baseline characteristics were well balanced across the two groups , and there were no significant differences in these characteristics except in the changes of PI from the baseline to the 90-day point .
RESULTS	There was a significant decrease of TCD PIs at 90-day study from baseline in the cilostazol group ( p = 0.02 ) .
RESULTS	The mean WMH volume was 11.57 cm ( 3 ) ( 0.13-68 .45 , median 4.86 ) and the mean MCA PI was 0.95 ( 0.62-1 .50 ) .
RESULTS	The changes in PIs from the baseline to 14 days and to 90 days were 0.09 ( -0.21 to 0.33 ) and 0.10 ( -0.22 to 0.36 ) .
RESULTS	While there were no significant correlations between WMH volume and the changes in PIs , a trend of inverse correlation was observed between the WMH volume and the changes in PIs from the baseline to the 90-day point .
RESULTS	For the subgroup analysis , the WMH volume was dichotomized based on its median value ( 4.90 cm ( 3 ) ) .
RESULTS	Cilostazol decreased the TCD PIs significantly at the 90-day point in patients with WMH volumes 4.9 cm ( 3 ) ( p = 0.002 ) .
RESULTS	Significant treatment effects were observed in the cilostazol group .
CONCLUSIONS	This study showed that cilostazol decreased cerebral arterial pulsatility in patients with WMH .
CONCLUSIONS	Our findings indicate the unique effect of cilostazol in small vessel disease ( SVD ) , especially in patients with mild WMH changes .
CONCLUSIONS	Further clinical trials focusing on WMH volume and clinical outcomes are required to assess the unique efficacy of cilostazol in SVD .

###24950690
OBJECTIVE	to examine the costs and cost-effectiveness of ` second-generation ' telecare , in addition to standard support and care that could include ` first-generation ' forms of telecare , compared with standard support and care that could include ` first-generation ' forms of telecare .
METHODS	a pragmatic cluster-randomised controlled trial with nested economic evaluation .
METHODS	A total of 2,600 people with social care needs participated in a trial of community-based telecare in three English local authority areas .
METHODS	In the Whole Systems Demonstrator Telecare Questionnaire Study , 550 participants were randomised to intervention and 639 to control .
METHODS	Participants who were offered the telecare intervention received a package of equipment and monitoring services for 12 months , additional to their standard health and social care services .
METHODS	The control group received usual health and social care .
METHODS	incremental cost per quality-adjusted life year ( QALY ) gained .
METHODS	The analyses took a health and social care perspective .
RESULTS	cost per additional QALY was 297,000 .
RESULTS	Cost-effectiveness acceptability curves indicated that the probability of cost-effectiveness at a willingness-to-pay of 30,000 per QALY gained was only 16 % .
RESULTS	Sensitivity analyses combining variations in equipment price and support cost parameters yielded a cost-effectiveness ratio of 161,000 per QALY .
CONCLUSIONS	while QALY gain in the intervention group was similar to that for controls , social and health services costs were higher .
CONCLUSIONS	Second-generation telecare did not appear to be a cost-effective addition to usual care , assuming a commonly accepted willingness to pay for QALYs .
BACKGROUND	ISRCTN 43002091 .

###24762458
BACKGROUND	According to a recent survey , the 2009 North American Society for Pediatric Gastroenterology , Hepatology , and Nutrition-European Society for Pediatric Gastroenterology , Hepatology , and Nutrition gastroesophageal reflux guidelines are poorly adhered to by European primary care pediatricians .
BACKGROUND	The main issue raised from the survey was the prescription of unnecessary acid suppressive medications , especially in infants .
BACKGROUND	No inquiry into the reasons was made .
BACKGROUND	The primary objective of the present study was to assess the applicability of the guidelines in European primary care pediatricians undergoing specific trainings .
METHODS	One hundred pediatricians involved in the previous survey agreed to participate and were randomly divided into 2 groups : one group was trained in the guidelines through an online podcast and the other group was trained through a synopsis .
METHODS	During the following 3 months , each involved pediatrician was asked to enroll every consecutive infant , child , or adolescent with suggestive reflux symptoms .
METHODS	For every enrolled patient , pediatricians filled in a report concerning their diagnostic and therapeutic choices .
RESULTS	A total of 382 patients ( boys/girls 186/196 , infants/children/adolescents 194/123/65 ) were enrolled by pediatricians .
RESULTS	Infants with unexplained crying and/or distressed behavior who were prescribed proton-pump inhibitors were 3.7 % compared with 45.2 % of the survey data obtained before the training ( P < 0.05 ) .
RESULTS	Infants with uncomplicated recurrent regurgitation and vomiting who were prescribed proton-pump inhibitors were 4.5 % against 37.1 % of the baseline survey data ( P < 0.05 ) .
RESULTS	The overall rate of children managed in full compliance with the guidelines was 46.1 % after the training compared with 1.8 % before the training ( P < 0.05 ) .
RESULTS	No significant differences were seen between pediatricians from podcast and synopsis group .
CONCLUSIONS	The North American Society for Pediatric Gastroenterology , Hepatology , and Nutrition-European Society for Pediatric Gastroenterology , Hepatology , and Nutrition gastroesophageal reflux guidelines have good applicability , despite that they are presently poorly adhered to by European primary care pediatricians .
CONCLUSIONS	Simple , inexpensive trainings were proven to be effective in increasing adherence by pediatricians .
CONCLUSIONS	The increase in compliance clearly favors the role of continuous medical education through simple educational tools and subsequent assessment of practice .

###24628464
BACKGROUND	Safety of individual probiotic strains approved under Investigational New Drug ( IND ) policies in cirrhosis with minimal hepatic encephalopathy ( MHE ) is not clear .
OBJECTIVE	The primary aim of this phase I study was to evaluate the safety , tolerability of probiotic Lactobacillus GG ( LGG ) compared to placebo , while secondary ones were to explore its mechanism of action using cognitive , microbiome , metabolome and endotoxin analysis in MHE patients .
METHODS	Cirrhotic patients with MHE patients were randomised 1:1 into LGG or placebo BID after being prescribed a standard diet and multi-vitamin regimen and were followed up for 8 weeks .
METHODS	Serum , urine and stool samples were collected at baseline and study end .
METHODS	Safety was assessed at Weeks 4 and 8 .
METHODS	Endotoxin and systemic inflammation , microbiome using multi-tagged pyrosequencing , serum/urine metabolome were analysed between groups using correlation networks .
RESULTS	Thirty MHE patients ( 14 LGG and 16 placebo ) completed the study without any differences in serious adverse events .
RESULTS	However , self-limited diarrhoea was more frequent in LGG patients .
RESULTS	A standard diet was maintained and LGG batches were comparable throughout .
RESULTS	Only in the LGG-randomised group , endotoxemia and TNF - decreased , microbiome changed ( reduced Enterobacteriaceae and increased Clostridiales Incertae Sedis XIV and Lachnospiraceae relative abundance ) with changes in metabolite/microbiome correlations pertaining to amino acid , vitamin and secondary BA metabolism .
RESULTS	No change in cognition was found .
CONCLUSIONS	In this phase I study , Lactobacillus GG is safe and well-tolerated in cirrhosis and is associated with a reduction in endotoxemia and dysbiosis .

###24766981
BACKGROUND	Heart failure ( HF ) carries poor prognosis in coronary artery disease ( CAD ) patients despite advances in therapy .
BACKGROUND	Inflammation predicts recurrent cardiovascular events in CAD patients .
BACKGROUND	It is unknown whether increased levels of inflammatory markers are associated with incident HF in these patients .
OBJECTIVE	The aims of this study were to evaluate the association between inflammatory markers and future HF risk in patients with stable CAD and to explore possible mediation by myocardial infarction ( MI ) .
METHODS	The study comprised 2,945 patients with stable CAD without HF at baseline during a median follow-up of 7.9 years .
METHODS	Inflammatory baseline markers were the basis of this study .
RESULTS	Heart failure was diagnosed in 508 patients ( 17.2 % ) .
RESULTS	Patients who developed HF were older and had more often previous MI , diabetes , hypertension , and peripheral vascular disease .
RESULTS	Baseline levels of C-reactive protein ( CRP ) , fibrinogen , and white blood cells ( WBCs ) were significantly higher in patients who developed HF compared with those who did not .
RESULTS	Age-adjusted incident HF rates were related to elevated baseline inflammatory markers in a dose-response manner .
RESULTS	Adjusting for multiple confounders , the HF hazard ratios were 1.38 ( 95 % CI 1.11-1 .72 ) , 1.33 ( 95 % CI 1.07-1 .66 ) , and 1.36 ( 95 % CI 1.10-1 .68 ) for the third tertiles of CRP , fibrinogen , and WBC levels , respectively .
RESULTS	Hazard ratio for the fifth quintile of a combined `` inflammation score '' was 1.83 ( 95 % CI 1.40-2 .39 ) .
RESULTS	Mediation by MI preceding the HF onset during follow-up accounted for 10.4 % , 10.8 % , and 8.6 % of the association of subsequent HF with CRP , fibrinogen , and WBC , respectively .
CONCLUSIONS	Increased levels of CRP , fibrinogen , and WBC are independently related to the incidence of HF in patients with stable CAD .

###25277170
BACKGROUND	There is no consensus regarding resection of the primary tumour with few or absent symptoms in patients with synchronous unresectable metastatic colorectal cancer ( CRC ) .
BACKGROUND	A potential benefit of resection of the primary tumour is to prevent complications of the primary tumour in later stages of the disease .
BACKGROUND	We here propose a randomized trial in order to demonstrate that resection of the primary tumour improves overall survival .
METHODS	The CAIRO4 study is a multicentre , randomized , phase III study of the Dutch Colorectal Cancer Group ( DCCG ) .
METHODS	Patients with synchronous unresectable metastases of CRC and few or absent symptoms of the primary tumour are randomized 1:1 between systemic therapy only , and resection of the primary tumour followed by systemic therapy .
METHODS	Systemic therapy will consist of fluoropyrimidine-based chemotherapy in combination with bevacizumab .
METHODS	The primary objective of this study is to determine the clinical benefit in terms of overall survival of initial resection of the primary tumour .
METHODS	Secondary endpoints include progression free survival , surgical morbidity , quality of life and the number of patients requiring resection of the primary tumour in the control arm .
CONCLUSIONS	The CAIRO4 study is a multicentre , randomized , phase III study that will assess the benefit of resection of the primary tumour in patients with synchronous metastatic CRC .
BACKGROUND	The CAIRO4 study is registered at clinicaltrials.gov ( NCT01606098 ) .

###25457739
BACKGROUND	Despite extensive research on gender differences in addiction , there are relatively few published reports comparing treatment outcomes for women versus men based on evidence-based treatments evaluated in randomized clinical trials .
METHODS	An aggregate sample comprised of data from five randomized clinical trials of treatment for cocaine dependence ( N = 434 ) was evaluated for gender differences in clinical outcomes .
METHODS	Secondary analyses compared gender differences in outcome by medication condition ( disulfiram versus no medication ) and across multiple behavioral treatment conditions .
RESULTS	Women , compared with men , had poorer treatment outcomes on multiple measures of cocaine use during treatment and at post-treatment follow-up .
RESULTS	These results appear to be primarily accounted for by disulfiram being less effective in women compared with men .
RESULTS	There was no evidence of meaningful gender differences in outcome as a function of the behavioral therapies evaluated .
CONCLUSIONS	These findings suggest that women and men may benefit to similar degrees from some empirically validated behavioral treatments for addiction .
CONCLUSIONS	Conversely , some addiction pharmacotherapies , such as disulfiram , may be associated with poorer outcomes among women relative to men and point to the need for careful assessment of pharmacological treatments in both sexes prior to widespread clinical implementation .

###25464463
BACKGROUND	The aim of this work was to evaluate the effect of high-intensity interval exercise ( i.e. , 30s at 100 % of max workload , followed by 30s at rest , 45 min 3 days/week working-out schedule for 12 weeks ) on left ventricular function and aortic elastic properties among chronic heart failure ( CHF ) patients .
METHODS	This study is a phase III clinical trial .
METHODS	Of the 100 consecutive CHF patients ( NYHA classes II-IV , ejection fraction < 50 % ) that were randomly allocated , 72 completed the study ( exercise training group , n = 33 , 63 9 years , 88 % men , and control group , n = 39 , 56 11 years , 82 % men ) .
METHODS	All patients underwent cardiopulmonary stress test , non-invasive high-fidelity tonometry of the radial artery , pulse wave velocity measurement using a SphygmoCor device and echocardiography before and after the completion of the training program .
RESULTS	Both groups reported similar medical characteristics and physical activity status .
RESULTS	General mixed effects models revealed that the intervention group reduced pulse wave velocity by 9 % ( p = 0.05 ) ; Emv/Vp by 14 % ( p = 0.06 ) ; E to A ratio by 24 % ( p = 0.004 ) , E to Emv ratio by 8 % ( p = 0.05 ) , MLHFQ score by 66 % ( p = 0.003 ) and the depression score by 19 % ( p = 0.5 ) ; increased augmentation index by 29 % ; VTI by 4 % ( p = 0.05 ) , 6-minute-walk distance up to 13 % ( p = 0.05 ) , peak oxygen uptake by 28 % ( p = 0.001 ) and peak power by 25 % ( p = 0.005 ) .
RESULTS	There were no significant changes in the control group .
CONCLUSIONS	Interval high-intensity aerobic training , combined with strength exercise , seems to benefit aortic dilatation capacity and augmented systolic pressure in parallel with improvement in left ventricular diastolic function and quality of life .

###25396263
OBJECTIVE	To conduct two economic analyses addressing whether to : routinely monitor HIV-infected children on antiretroviral therapy ( ART ) clinically or with laboratory tests ; continue or stop cotrimoxazole prophylaxis when children become stabilized on ART .
METHODS	The ARROW randomized trial investigated alternative strategies to deliver paediatric ART and cotrimoxazole prophylaxis in 1206 Ugandan/Zimbabwean children .
METHODS	Incremental cost-effectiveness and value of implementation analyses were undertaken .
METHODS	Scenario analyses investigated whether laboratory monitoring ( CD4 tests for efficacy monitoring ; haematology/biochemistry for toxicity ) could be tailored and targeted to be delivered cost-effectively .
METHODS	Cotrimoxazole use was examined in malaria-endemic and non-endemic settings .
RESULTS	Using all trial data , clinical monitoring delivered similar health outcomes to routine laboratory monitoring , but at a reduced cost , so was cost-effective .
RESULTS	Continuing cotrimoxazole improved health outcomes at reduced costs .
RESULTS	Restricting routine CD4 monitoring to after 52 weeks following ART initiation and removing toxicity testing was associated with an incremental cost-effectiveness ratio of $ 6084 per quality-adjusted life-year ( QALY ) across all age groups , but was much lower for older children ( 12 + years at initiation ; incremental cost-effectiveness ratio = $ 769/QALY ) .
RESULTS	Committing resources to improve cotrimoxazole implementation appears cost-effective .
RESULTS	A healthcare system that could pay $ 600/QALY should be willing to spend up to $ 12.0 per patient-year to ensure continued provision of cotrimoxazole .
CONCLUSIONS	Clinically driven monitoring of ART is cost-effective in most circumstances .
CONCLUSIONS	Routine laboratory monitoring is generally not cost-effective at current prices , except possibly CD4 testing amongst adolescents initiating ART .
CONCLUSIONS	Committing resources to ensure continued provision of cotrimoxazole in health facilities is more likely to represent an efficient use of resources .

###24762958
BACKGROUND	The SHIVA trial is a multicentric randomised proof-of-concept phase II trial comparing molecularly targeted therapy based on tumour molecular profiling vs conventional therapy in patients with any type of refractory cancer .
BACKGROUND	RESULTS of the feasibility study on the first 100 enrolled patients are presented .
METHODS	Adult patients with any type of metastatic cancer who failed standard therapy were eligible for the study .
METHODS	The molecular profile was performed on a mandatory biopsy , and included mutations and gene copy number alteration analyses using high-throughput technologies , as well as the determination of oestrogen , progesterone , and androgen receptors by immunohistochemistry ( IHC ) .
RESULTS	Biopsy was safely performed in 95 of the first 100 included patients .
RESULTS	Median time between the biopsy and the therapeutic decision taken during a weekly molecular biology board was 26 days .
RESULTS	Mutations , gene copy number alterations , and IHC analyses were successful in 63 ( 66 % ) , 65 ( 68 % ) , and 87 ( 92 % ) patients , respectively .
RESULTS	A druggable molecular abnormality was present in 38 patients ( 40 % ) .
CONCLUSIONS	The establishment of a comprehensive tumour molecular profile was safe , feasible , and compatible with clinical practice in refractory cancer patients .

###25137428
BACKGROUND	Aromatase inhibitors are used off-label to treat short stature in peripubertal boys .
OBJECTIVE	To investigate short - and long-term hormonal and auxologic differences in short pubertal boys treated with letrozole ( L ) or anastrozole ( A ) .
METHODS	PATIENTS are seen for laboratory evaluation and physical examination every 6 months , bone age yearly , DEXA and spine film every 2 years .
METHODS	They will be followed until they reach their final height .
METHODS	This is a preliminary report after 1 year of treatment .
METHODS	A single academic children 's hospital outpatient clinic .
METHODS	Boys with age > 10 years , bone age 14 years , clinical and hormonal evidence of central puberty , and either height < fifth percentile or predicted adult height ( PAH ) more than 10 cm below mid-parental height ( MPH ) .
METHODS	Letrozole ( 2.5 mg ) or anastrozole ( 1 mg ) was administered orally each day .
METHODS	Hormonal and clinical parameters , growth velocity , and change in bone age and PAH .
RESULTS	Thirty-nine boys have completed 1 year of treatment .
RESULTS	Baseline means were age 14.1 years , PAH 166 cm , and testosterone 198 ng/dL .
RESULTS	At 1 year , letrozole resulted in higher LH ( L 6.1 2.5 vs A 3.2 1.7 IU/L ) and testosterone ( 1038 348 vs 536 216 ng/dL ) with lower estradiol ( 2.8 2.8 vs 5.6 2.9 pg/mL ) and IGF-1 ( 237 51 vs 331 79 ng/mL ) .
RESULTS	First year growth velocities were identical ( 7.2 cm/year ) , but an increase in PAH was greater in the anastrozole group ( 4.2 3.5 vs 1.4 4.4 cm , p = 0.03 ) after 1 year .
CONCLUSIONS	We present first-year data from a direct comparison of anastrozole and letrozole for height augmentation in short pubertal boys .
CONCLUSIONS	Letrozole was more potent in hormonal manipulation than anastrozole .
CONCLUSIONS	First-year growth velocities were comparable , but improvement in PAH was greater in the anastrozole group .
CONCLUSIONS	It remains to be seen if positive PAH trends will translate to increase in final height in either group .

###25153084
BACKGROUND	PEARLS , a large scale trial of antiretroviral therapy ( ART ) for HIV ( n = 1,571 , 9 countries , 4 continents ) , found that a once-daily protease inhibitor ( PI ) based regimen ( ATV+DDI+FTC ) , but not a once-daily non-nucleoside reverse transcriptase inhibitor/nucleoside reverse transcriptase inhibitor ( NNRTI/NRTI ) regimen ( EFV+FTC / TDF ) , had inferior efficacy compared to a standard of care twice-daily NNRTI/NRTI regimen ( EFV +3 TC/ZDV ) .
BACKGROUND	The present study examined non-adherence in PEARLS .
METHODS	Outcomes : non-adherence assessed by pill count and by self-report , and time to treatment failure .
METHODS	Longitudinal predictors : regimen , quality of life ( general health perceptions = QOL-health , mental health = QOL-mental health ) , social support , substance use , binge drinking , and sexual behaviors .
METHODS	`` Life-Steps '' adherence counseling was provided .
RESULTS	In both pill-count and self-report multivariable models , both once-a-day regimens had lower levels of non-adherence than the twice-a-day standard of care regimen ; although these associations attenuated with time in the self-report model .
RESULTS	In both multivariable models , hard-drug use was associated with non-adherence , living in Africa and better QOL-health were associated with less non-adherence .
RESULTS	According to pill-count , unprotected sex was associated with non-adherence .
RESULTS	According to self-report , soft-drug use was associated with non-adherence and living in Asia was associated with less non-adherence .
RESULTS	Both pill-count ( HR = 1.55 , 95 % CI : 1.15 , 2.09 , p < .01 ) and self-report ( HR = 1.13 , 95 % CI : 1.08 , 1.13 , p < .01 ) non-adherence were significant predictors of treatment failure over 72 weeks .
RESULTS	In multivariable models ( including pill-count or self-report nonadherence ) , worse QOL-health , age group ( younger ) , and region were also significant predictors of treatment failure .
CONCLUSIONS	In the context of a large , multi-national , multi-continent , clinical trial there were variations in adherence over time , with more simplified regimens generally being associated with better adherence .
CONCLUSIONS	Additionally , variables such as QOL-health , regimen , drug-use , and region play a role .
CONCLUSIONS	Self-report and pill-count adherence , as well as additional psychosocial variables , such QOL-health , age , and region , were , in turn , associated with treatment failure .

###24762026
BACKGROUND	Therapeutic adherence of patients with chronic obstructive pulmonary disease ( COPD ) is poor .
BACKGROUND	This study evaluated the effectiveness of a multifactorial intervention on improving the therapeutic adherence in chronic obstructive pulmonary disease ( COPD ) patients with scheduled inhalation therapy .
METHODS	The study design consisted of a randomised controlled trial in a primary care setting .
METHODS	146 patients diagnosed with COPD were randomly allocated into two groups using the block randomisation technique .
METHODS	One-year follow-ups with three visits were performed .
METHODS	The intervention consisted of motivational aspects related to adherence ( beliefs and behaviour ) in the form of group and individual interviews , cognitive aspects in the form of information about the illness and skills in the form of training in inhalation techniques .
METHODS	Cognitive-emotional aspects and training in inhalation techniques were reinforced during all visits of the intervention group .
METHODS	The main outcome measure was adherence to the medication regimen .
METHODS	Therapeutic adherence was determined by the percentage of patients classified as good adherent as evaluated by dose or pill count .
RESULTS	Of the 146 participants ( mean age 69.8 years , 91.8 % males ) , 41.1 % reported adherence ( 41.9 % of the control group and 40.3 % of the intervention group ) .
RESULTS	When multifactorial intervention was applied , the reported adherence was 32.4 % for the control group and 48.6 % for the intervention group , which showed a statistically significant difference ( p = 0.046 ) .
RESULTS	Number needed to treat is 6.37 .
RESULTS	In the intervention group , cognitive aspects increased by 23.7 % and skilled performance of inhalation techniques increased by 66.4 % .
RESULTS	The factors related to adherence when multifactorial intervention was applied were the number of exacerbations ( OR = 0.66 ) , visits to health centre ( OR = 0.93 ) and devices ( OR = 2.4 ) ; illness severity ( OR = 0.67 ) , beta-2-adrenergic ( OR = 0.16 ) and xantine ( OR = 0.19 ) treatment ; activity ( OR = 1.03 ) and impact ( OR = 1.03 ) scales of the Saint George Respiratory Questionnaire .
CONCLUSIONS	Application of the multifactorial intervention designed for this study ( COPD information , dose reminders , audio-visual material , motivational aspects and training in inhalation techniques ) resulted in an improvement in therapeutic adherence in COPD patients with scheduled inhalation therapy .
BACKGROUND	Current Controlled Trials ISRCTN18841601 .

###25088638
OBJECTIVE	To assess the bacterial contamination risk in cataract surgery associated with mechanical compression of the lid margin immediately after sterilization of the ocular surface .
METHODS	Department of Cataract , Zhongshan Ophthalmic Center , Sun Yat-sen University , Guangzhou , China .
METHODS	Prospective randomized controlled double-masked trial .
METHODS	Patients with age-related cataract were randomly assigned to 1 of 2 groups .
METHODS	In Group A ( 153 eyes ) , the lid margin was compressed and scrubbed for 360 degrees 5 times with a dry sterile cotton-tipped applicator immediately after ocular sterilization and before povidone-iodine irrigation of the conjunctival sac .
METHODS	Group B ( 153 eyes ) had identical sterilization but no lid scrubbing .
METHODS	Samples from the lid margin , liquid in the collecting bag , and aqueous humor were collected for bacterial culture .
METHODS	Primary outcome measures included the rate of positive bacterial culture for the above samples .
METHODS	The species of bacteria isolated were recorded .
RESULTS	Group A and Group B each comprised 153 eyes .
RESULTS	The positive rate of lid margin cultures was 54.24 % .
RESULTS	The positive rate of cultures for liquid in the collecting bag was significantly higher in Group A ( 23.53 % ) than in Group B ( 9.80 % ) ( P = .001 ) .
RESULTS	The bacterial species cultured from the collecting bag in Group B were the same as those from the lid margin in Group A.
RESULTS	The positive culture rate of aqueous humor in both groups was 0 % .
CONCLUSIONS	Mechanical compression of the lid margin immediately before and during cataract surgery increased the risk for bacterial contamination of the surgical field , perhaps due to secretions from the lid margin glands .
BACKGROUND	No author has a financial or proprietary interest in any material or method mentioned .

###24963599
OBJECTIVE	To evaluate the physiologic and psychological effects of an equine-assisted therapy protocol ( EAT ) in breast cancer survivors .
METHODS	Twenty women ( mean age , 45.612.71 years ) whose breast cancer treatment had concluded at least 6 months previously underwent a screening protocol to certify their eligibility to participate in noncompetitive sports .
METHODS	The patients were randomly assigned to an intervention group ( n = 10 ) or a control group ( n = 10 ) .
METHODS	Intervention patients participated in a 16-week EAT protocol consisting of 2 hours of activity per week .
METHODS	All patients were tested before and after the intervention for maximal oxygen consumption ( VO2max ) , fat mass percentage , total body water percentage , strength of principal muscular groups ( measured on five weight-lifting machines [ leg press , leg extension , leg curl , shoulder press , vertical traction ] ) , and quality of life using the Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire ( FACIT-F ) .
RESULTS	After intervention , the intervention group showed an improvement in VO2max ( 28.29 % ; p < .001 ) , a decrease in fat mass percentage ( change , -7.73 % ; p < 0.002 ) , an increase in total body water percentage ( 6.90 % ; p = 0.027 ) , and an increase in strength ( leg press , 17.75 % [ p = 0.018 ] ; leg extension , 21.55 % [ p = 0.005 ] ; leg curl , 26.04 % [ p < 0.001 ] ; shoulder press , 49.72 % [ p = 0.003 ] ; vertical traction , 19.27 % [ p = 0.002 ] ) .
RESULTS	Furthermore , the increase in the three FACIT-F scores ( FACIT-F trial outcome : 9.29 % [ p = 0.010 ] ; Functional Assessment of Cancer Therapy-General total score , 14.80 % [ p = 0.022 ] ; FACIT-F total score , 11.48 % [ p = 0.004 ] ) showed an increase in quality of life .
RESULTS	No significant changes for any variable were found for the control group .
CONCLUSIONS	EAT had positive effects on both physiologic and psychological measures , enhancing quality of life of breast cancer survivors .
CONCLUSIONS	RESULTS suggest a new method for rehabilitation intervention strategies after cancer in a nonmedical environment .

###24565127
OBJECTIVE	In our study we aimed to investigate the effect of bupivacaine and levobupivacaine on QT , corrected QT ( QTc ) , and P wave dispersion durations during spinal anesthesia in cesarean section .
METHODS	Sixty parturients scheduled for elective cesarean section in ASA I-II risk groups were included in the study .
METHODS	Baseline electrocardiographic ( ECG ) records of the patients were obtained in the operation room .
METHODS	Heart rate ( HR ) , non-invasive blood pressure ( NIBP ) , peripheral oxygen saturation ( SpO2 ) and respiration rates ( RR ) were recorded .
METHODS	Venous cannulation was performed with 18G cannula and fluid preload made with 10 mL.kg ( -1 ) .
METHODS	Lactated Ringer solution .
METHODS	After fluid preload , second ECG recordings were taken and the patients were randomly separated into two groups .
METHODS	Group B ( n = 30 ) received 10mg of bupivacaine and Group L ( n = 30 ) received 10mg of levobupivacaine for spinal anesthesia .
METHODS	ECG recordings were repeated at 1 , 5 and 10 minutes after spinal block .
METHODS	HR , NIBP , SpO2 , RR and sensory block levels were also recorded at the same time intervals .
METHODS	At predetermined time intervals of spinal anesthesia , P wave dispersion ( Pwd ) , QT dispersion ( QTd ) , and QTc dispersion ( QTcd ) durations were measured from ECG records .
METHODS	QT and QTc durations are calculated with Bazzett formula .
RESULTS	There was no difference between two groups according to block levels , hemodynamic parameters , Pwd , QTd , QTc and QTcd durations .
CONCLUSIONS	Bupivacaine and levobupivacaine may be preferred in spinal anesthesia in pregnant patients who have extended Pwd and QTcd preoperatively .

###24943252
OBJECTIVE	To compare radiation exposure and image quality in children undergoing torso helical acquisition computed tomography ( CT ) using filtered back projection ( FBP ) or adaptive iterative dose reduction ( AIDR ) 3D reconstruction algorithms .
OBJECTIVE	A secondary purpose is to compare radiation exposure and image quality in children undergoing torso CT acquired with helical or wide-detector techniques reconstructed with AIDR 3D .
METHODS	The study was approved by the institutional review board .
METHODS	Phase 1 included 200 helical torso CT studies : 100 using FBP and 100 using AIDR 3D .
METHODS	The size-specific dose estimate ( SSDE ) was calculated for each study .
METHODS	Region of interest ( ROI ) noise measurements were recorded in the thorax , abdomen , and pelvis for each study .
METHODS	Unpaired t tests compared SSDE and image noise for each group .
METHODS	Phase 2 included 100 wide-detector CT torso studies using AIDR 3D .
METHODS	Size-specific dose estimate and ROI noise measurements were calculated .
METHODS	Unpaired t tests compared helical and wide-detector SSDE and ROI .
METHODS	Additional t tests looked for age - and weight-specific differences in the helical and wide-detector groups .
RESULTS	Phase 1 : AIDR 3D showed significant reduction in SSDE ( P = 0.0001 ) and significant improvement in image quality .
RESULTS	Phase 2 : no significant difference in SSDE was observed .
RESULTS	Children younger than 6 years had a significant reduction in SSDE with wide-detector technique ( P = 0.0445 ) with no loss in image quality .
CONCLUSIONS	Adaptive iterative dose reduction 3D produces significant reduction in radiation dose without degradation to image quality compared with FBP .
CONCLUSIONS	Significant dose reduction without loss of image quality can also be obtained in younger , smaller children using wide-detector technique .

###24512461
CONCLUSIONS	The patients who underwent septoplasty with bilateral totally occlusive nasal packing had an increased risk of experiencing respiratory distress ( RD ) .
OBJECTIVE	To compare the immediate RD rates during recovery from anesthesia and surgical complications of totally occlusive nasal pack , internal nasal splint , and transseptal suture technique .
METHODS	A total of 150 patients were assigned to one of three groups according to the technique utilized following septoplasty : transseptal suturing , internal nasal splint , or Merocel ( nasal dressing without airway ) .
METHODS	To determine RD related to anesthesia in the operating theatre , the criterion was defined as any unanticipated hypoxemia , hypoventilation or upper airway obstruction ( stridor or laryngospasm ) requiring an active and specific intervention .
METHODS	Postoperative hemorrhage , infection , synechia formation , and septal perforation were evaluated .
RESULTS	Patients in the Merocel group were 3.6 times more likely to have RD than patients in the transseptal suture and internal nasal splint groups .
RESULTS	Also , patients who smoked had an increased risk of RD during the recovery phase of anesthesia after the septoplasty .
RESULTS	In addition , all three techniques resulted in similar complication rates after septoplasty , with the exception of minor hemorrhage , which had a significantly higher rate in the transseptal suture group .

###24869609
BACKGROUND	Pre-emptive intravenous lidocaine infusion is known to improve postoperative pain in abdominal surgery .
BACKGROUND	We assessed the effect of intravenous lidocaine infusion in patients who underwent subtotal gastrectomy .
METHODS	We conducted a double-blind , placebo-controlled study with patients undergoing subtotal gastrectomy for early gastric cancer divided into 2 groups : 1 group received intravenous lidocaine infusion preoperatively and throughout surgery , and the other received normal saline infusion ( placebo ) .
METHODS	We assessed postoperative outcomes , including pain scores on a visual analogue scale ( VAS ) , administration frequency of patient-controlled analgesia ( PCA ) and the amount of consumed fentanyl .
METHODS	Postoperative nausea and vomiting , length of hospital stay ( LOS ) , time to return to regular diet and patient satisfaction at discharge were evaluated .
RESULTS	There were 36 patients in our study .
RESULTS	Demographic characteristics were similar between the groups .
RESULTS	The VAS pain scores and administration frequency of PCA were significantly lower in the lidocaine group until 24 hours after surgery , and fentanyl consumption was significantly lower in this group until 12 hours postoperatively compared with the placebo group .
RESULTS	The total amount of consumed fentanyl and the total administration frequency of PCA were significantly lower in the lidocaine than the control group .
RESULTS	No significant differences were detected in terms of nausea and vomiting , return to regular diet , LOS and patient satisfaction , and there were no reported side-effects of lidocaine .
CONCLUSIONS	Intravenous lidocaine infusion reduces pain during the postoperative period after subtotal gastrectomy .

###25661906
BACKGROUND	Blood conservation using autologous platelet-rich plasma ( aPRP ) , a technique of whole blood harvest that separates red blood cells from plasma and platelets before cardiopulmonary bypass with retransfusion of the preserved platelets after completion of cardiopulmonary bypass , has not been studied extensively .
BACKGROUND	We sought to prospectively determine whether aPRP reduces blood transfusions during ascending and transverse aortic arch repair .
METHODS	We randomly assigned 80 patients undergoing elective ascending and transverse aortic arch repair using deep hypothermic circulatory arrest to receive either aPRP ( n = 38 ) or no aPRP ( n = 42 ) .
METHODS	Volume of aPRP retransfused was 726 124 mL .
METHODS	The primary end point was transfusion amount .
METHODS	Secondary end points were death , stroke , renal failure , pulmonary failure , and transfusion costs .
METHODS	Perioperative transfusion rate was defined as blood transfusions given during surgery and up to 72 hours afterward .
METHODS	The surgeon and intensivist were blinded to the treatment arm .
METHODS	Because an anesthesiologist initiated the protocol , the surgeon was not aware of aPRP collection , as this occurred only after the sterile drape was in place .
METHODS	In addition , because cell salvage was performed on all cases , differentiation in perfusionist activities ( during spinning of aPRP ) was not evident .
METHODS	Platelet , fresh frozen plasma , and cryoprecipitate intraoperative transfusions were performed only after heparin was reversed and the patient was judged as coagulopathic on the basis of associated criteria : cryoprecipitate transfusion for fibrinogen level less than 150 g/dL , platelet transfusion for platelet count less than 80,000 , and fresh frozen plasma when thromboelastogram test was suggestive or a partial thromboplastin time was greater than 55 seconds , and prothrombin time was greater than 1.6 seconds .
RESULTS	Early mortality , stroke , and respiratory complications were similar between groups .
RESULTS	Only acute renal failure was reduced in the aPRP group , 7 % versus 0 % ( p < 0.014 ) .
RESULTS	Mean transfusion rate of packed red blood cells was reduced by 34 % , fresh frozen plasma by 52.8 % , cryoprecipitate by 70 % , and platelets by 56.7 % in the aPRP group ( p < 0.02 ) .
RESULTS	Hospital length of stay ( 9.4 5.3 days versus 12.7 6.3 days ; p < 0.014 ) and transfusion costs ( $ 1,396 $ 1,755 versus $ 2,762 $ 2,267 ; p < 0.004 ) were reduced in the aPRP group .
CONCLUSIONS	The use of aPRP reduced allogeneic transfusions during ascending and transverse aortic arch repair with deep hypothermic circulatory arrest .
CONCLUSIONS	This translated to less acute renal failure , decreased length of stay , and lower transfusion costs .
CONCLUSIONS	Further studies examining the coagulation factors of aPRP are required .

###24962086
BACKGROUND	Despite 10 to % of persons living with HIV in sub-Saharan Africa having clinical depression , and the consequences of depression for key public health outcomes ( HIV treatment adherence and condom use ) , depression treatment is rarely integrated into HIV care programs .
BACKGROUND	Task-shifting , protocolized approaches to depression care have been used to overcome severe shortages of mental health specialists in developing countries , but not in sub-Saharan Africa and not with HIV clients .
BACKGROUND	The aims of this trial are to evaluate the implementation outcomes and cost-effectiveness of a task-shifting , protocolized model of antidepressant care for HIV clinics in Uganda .
METHODS	INDEPTH-Uganda is a cluster randomized controlled trial that compares two task-shifting models of depression care -- a protocolized model versus a model that relies on the clinical acumen of trained providers to provide depression care in ten public health HIV clinics in Uganda .
METHODS	In addition to data abstracted from routine data collection mechanisms and supervision logs , survey data will be collected from patient and provider longitudinal cohorts ; at each site , a random sample of 150 medically stable patients who are depressed according to the PHQ-2 screening will be followed for 12 months , and providers involved in depression care implementation will be followed over 24 months .
METHODS	These data will be used to assess whether the two models differ on implementation outcomes ( proportion screened , diagnosed , treated ; provider fidelity to model of care ) , provider adoption of treatment care knowledge and practices , and depression alleviation .
METHODS	A cost-effectiveness analysis will be conducted to compare the relative use of resources by each model .
CONCLUSIONS	If effective and resource-efficient , the task-shifting , protocolized model will provide an approach to building the capacity for sustainable integration of depression treatment in HIV care settings across sub-Saharan Africa and improving key public health outcomes .
BACKGROUND	INDEPTH-Uganda has been registered with the National Institutes of Health sponsored clinical trials registry ( 3 February 2013 ) and has been assigned the identifier NCT02056106 .

###24333009
BACKGROUND	Aromatase inhibitors effectively prevent breast cancer recurrence and development of new contralateral tumours in postmenopausal women .
BACKGROUND	We assessed the efficacy and safety of the aromatase inhibitor anastrozole for prevention of breast cancer in postmenopausal women who are at high risk of the disease .
METHODS	Between Feb 2 , 2003 , and Jan 31 , 2012 , we recruited postmenopausal women aged 40-70 years from 18 countries into an international , double-blind , randomised placebo-controlled trial .
METHODS	To be eligible , women had to be at increased risk of breast cancer ( judged on the basis of specific criteria ) .
METHODS	Eligible women were randomly assigned ( 1:1 ) by central computer allocation to receive 1 mg oral anastrozole or matching placebo every day for 5 years .
METHODS	Randomisation was stratified by country and was done with blocks ( size six , eight , or ten ) .
METHODS	All trial personnel , participants , and clinicians were masked to treatment allocation ; only the trial statistician was unmasked .
METHODS	The primary endpoint was histologically confirmed breast cancer ( invasive cancers or non-invasive ductal carcinoma in situ ) .
METHODS	Analyses were done by intention to treat .
METHODS	This trial is registered , number ISRCTN31488319 .
RESULTS	1920 women were randomly assigned to receive anastrozole and 1944 to placebo .
RESULTS	After a median follow-up of 50 years ( IQR 30-71 ) , 40 women in the anastrozole group ( 2 % ) and 85 in the placebo group ( 4 % ) had developed breast cancer ( hazard ratio 047 , 95 % CI 032-068 , p < 00001 ) .
RESULTS	The predicted cumulative incidence of all breast cancers after 7 years was 56 % in the placebo group and 28 % in the anastrozole group .
RESULTS	18 deaths were reported in the anastrozole group and 17 in the placebo group , and no specific causes were more common in one group than the other ( p = 0836 ) .
CONCLUSIONS	Anastrozole effectively reduces incidence of breast cancer in high-risk postmenopausal women .
CONCLUSIONS	This finding , along with the fact that most of the side-effects associated with oestrogen deprivation were not attributable to treatment , provides support for the use of anastrozole in postmenopausal women at high risk of breast cancer .
BACKGROUND	Cancer Research UK , the National Health and Medical Research Council Australia , Sanofi-Aventis , and AstraZeneca .

###25178312
BACKGROUND	To determine if risk stratification followed by rapid geriatric screening in an emergency department ( ED ) reduced functional decline , ED reattendance and hospitalisation .
METHODS	This was a quasi-randomised controlled trial .
METHODS	Patients were randomised by the last digit of their national registration identity card ( NRIC ) .
METHODS	Odd number controls received standard ED care ; even number patients received geriatric screening , followed by intervention and/or onward referrals .
METHODS	Patients were followed up for 12months .
RESULTS	There were 500 and 280 patients in the control and intervention groups .
RESULTS	The intervention group had higher Triage Risk Screening Tool ( TRST ) scores ( 34.3 % vs 25.4 % TRST 3 , p = 0.01 ) and lower baseline Instrumental Activity of Daily Living ( IADL ) scores ( 22.84 vs 24.18 , p < 0.01 ) .
RESULTS	82.9 % of the intervention group had unmet needs ; 62.1 % accepted our interventions .
RESULTS	Common positive findings were fall risk ( 65.0 % ) , vision ( 61.4 % ) , and footwear ( 58.2 % ) .
RESULTS	28.2 % were referred to a geriatric clinic and 11.8 % were admitted .
RESULTS	425 ( 85.0 % ) controls and 234 ( 83.6 % ) in the intervention group completed their follow-up .
RESULTS	After adjusting for TRST and baseline IADL , the intervention group had significant preservation in function ( Basic ADL -0.99 vs -0.24 , p < 0.01 ; IADL -2.57 vs +0.45 , p < 0.01 ) at 12months .
RESULTS	The reduction in ED reattendance ( OR0 .75 , CI 0.55-1 .03 , p = 0.07 ) and hospitalization ( OR0 .77 , CI0.57-1 .04 , p = 0.09 ) were not significant , however the real difference would have been wider as 21.2 % of the control group received geriatric screening at the request of the ED doctor .
RESULTS	A major limitation was that a large proportion of patients who were randomized to the intervention group either refused ( 18.8 % ) or left the ED before being approached ( 32.0 % ) .
RESULTS	These two groups were not followed up , and hence were excluded in our analysis .
CONCLUSIONS	Risk stratification and focused geriatric screening in ED resulted in significant preservation of patients ' function at 12months .
BACKGROUND	National Healthcare Group ( NHG ) Domain Specific Review Board ( DSRB ) C/09/023 .
BACKGROUND	Registered 5th March 2009 .

###25659139
BACKGROUND	Mammographic density is a strong risk factor for breast cancer and is highly variable , but , to date , few studies have examined density in Asian women , particularly those in low and middle-income Asian countries where genetic and lifestyle determinants may be significantly different .
METHODS	A total of 1,240 women who attended an opportunistic mammogram screening programme were eligible for analysis .
METHODS	Mammographic density was estimated using a fully-automated thresholding method and differences across ethnic groups were examined using linear regression in 205 randomly selected Chinese women , 138 Malay and 199 Indian women .
RESULTS	Percent density was significantly higher in Chinese women ( 28.5 % ; 95 % CI 27.0 % , 30.0 % ) compared to Malay ( 24.2 % ; 95 % CI 22.5 % , 26.0 % ) and Indian ( 24.3 % ; 95 % CI 22.8 % , 25.7 % ) women ( p < 0.001 ) , after adjustment for age , BMI , menopausal status , parity and age at first full term pregnancy .
RESULTS	Correspondingly , adjusted nondense area was significantly lower in Chinese ( 72.2 cm2 ; 95 % CI 67.9 cm2 , 76.5 cm2 ) women compared to Malay ( 92.1 cm2 ; 95 % CI 86.9 cm2 , 97.2 cm2 ) and Indian ( 97.7 cm2 ; 95 % CI 93.4 cm2 , 101.9 cm2 ) women ( p < 0.001 ) , but dense area did not differ across the three ethnic groups .
CONCLUSIONS	Our study shows that higher percent density and lower nondense area reflect the higher incidence of breast cancer in Chinese compared to Malay and Indian women in Malaysia .
CONCLUSIONS	Known lifestyle determinants of mammographic density do not fully account for the ethnic variations observed in mammographic density in this Asian cohort .

###24747996
BACKGROUND	Many workers suffer from low-back pain .
BACKGROUND	Type and severity of spinal complaints have relationship with work load .
BACKGROUND	Lack of adherence to ergonomics recommendations among the important causes of low-back pain .
OBJECTIVE	To assess the effect of 3 ergonomics training programs on the prevalence of lowback pain among workers of an Iranian automobile factory .
METHODS	In a parallel-design 4-arm randomized clinical trial , 760 active workers of an automobile factory were studied .
METHODS	503 workers were found eligible and randomized into 3 intervention groups ( n = 252 ) , and a control group ( n = 251 ) .
METHODS	The intervention groups consisted of 3 arms : 84 workers were educated by pamphlet , 84 by lectures , and 84 by workshop .
METHODS	Nordic questionnaire was used to determine the prevalence of spinal complaint before and 1-year after the interventions .
METHODS	The trial is registered with the Iranian Randomized Clinical Trial Registry , number IRCT2013061213182N2 .
RESULTS	Out of 503 workers , 52 lost to follow-up leaving 451 workers for analyses .
RESULTS	The prevalence of low-back pain at the baseline was not significantly different among the studied arms .
RESULTS	1-year after the interventions , the prevalence did not change significantly from the baseline values for the lecture and pamphlet group .
RESULTS	However , the prevalence of LBP experienced during the last year significantly ( p = 0.036 ) decreased from 42 % to 23 % in participant took part in the workshop .
CONCLUSIONS	Training of automobile factory workers in ergonomics is more effective by running workshop than giving lecture or disseminating pamphlet .

###24567279
BACKGROUND	The antiepileptic drug lacosamide has a low potential for drug-drug interactions , but is a substrate and moderate inhibitor of the cytochrome P450 ( CYP ) enzyme CYP2C19 .
OBJECTIVE	This phase I , randomized , open-label , two-way crossover trial evaluated the pharmacokinetic effects of lacosamide and omeprazole coadministration .
METHODS	Healthy , White , male volunteers ( n = 36 ) who were not poor metabolizers of CYP2C19 were randomized to treatment A ( single-dose 40 mg omeprazole on days 1 and 8 together with 6 days of multiple-dose lacosamide [ 200-600 mg/day ] on days 3-8 ) and treatment B ( single doses of 300 mg lacosamide on days 1 and 8 with 7 days of 40 mg/day omeprazole on days 3-9 ) in pseudorandom order , separated by a 7-day washout period .
METHODS	Area under the concentration-time curve ( AUC ) and peak concentration ( C ( max ) ) were the primary pharmacokinetic parameters measured for lacosamide or omeprazole administered alone ( reference ) or in combination ( test ) .
METHODS	Bioequivalence was determined if the 90 % confidence interval ( CI ) of the ratio ( test/reference ) fell within the acceptance range of 0.8-1 .25 .
RESULTS	The point estimates ( 90 % CI ) of the ratio of omeprazole + lacosamide coadministered versus omeprazole alone for AUC ( 1.098 [ 0.996-1 .209 ] ) and C ( max ) ( 1.105 [ 0.979-1 .247 ] ) fell within the acceptance range for bioequivalence .
RESULTS	The point estimates ( 90 % CI ) of the ratio of lacosamide + omeprazole coadministration versus lacosamide alone also fell within the acceptance range for bioequivalence ( AUC 1.133 [ 1.102-1 .165 ] ) ; C ( max ) 0.996 ( 0.947-1 .047 ) .
CONCLUSIONS	Steady-state lacosamide did not influence omeprazole single-dose pharmacokinetics , and multiple-dose omeprazole did not influence lacosamide single-dose pharmacokinetics .

###25490610
BACKGROUND	The prevalence of hepatitis-C-virus ( HCV ) infections is high among opioid-dependent individuals .
BACKGROUND	Prior research on the simultaneous treatment of both conditions has primarily assessed success as it pertains to HCV .
BACKGROUND	However , it has been noted that favorable substance use therapy outcomes may improve the likelihood of HCV-treatment initiation and success .
BACKGROUND	Therefore , current guidelines for the treatment of HCV among illicit drug users suggest that treatment for addiction be given the highest priority .
OBJECTIVE	To determine whether opioid-dependent participants in a clinical trial of buprenorphine-treatment tapering regimens , who tested positive for the HCV antibody , experienced significantly different levels of opioid abstinence than those not infected .
METHODS	Data came from the National Drug Abuse Treatment Clinical Trial Network study 0003.516 eligible opioid-dependent participants were randomized to either a 7-day or 28-day buprenorphine tapering schedule following a 4-week buprenorphine stabilization period .
METHODS	Generalized estimating equations were used to test the research question .
RESULTS	Participants with the HCV antibody were significantly less likely to submit opioid-negative urine analyses during and/or immediately following active treatment [ OR = 0.69 ; CI = 0.51-0 .93 ] , indicating a higher rate of opioid use among this group .
CONCLUSIONS	Individualized opioid-dependence treatment strategies may be required for opioid-dependent individuals who test positive for the HCV antibody in order to ensure resources for both opioid-dependence and HCV therapies are used efficiently .

###24629631
BACKGROUND	Crack-cocaine dependence is a complex disorder with limited treatment options .
BACKGROUND	Topiramate is one of the promising medications with reported reductions in cocaine use and craving in former studies .
BACKGROUND	The present study evaluated the acceptance and effectiveness of topiramate as an add-on to cognitive behavioral therapy ( CBT ) in crack-cocaine dependent patients .
METHODS	Seventy-four crack-cocaine dependent outpatients participated in an open-label , randomized feasibility trial .
METHODS	They were randomized to receive either 12-week CBT plus topiramate ( 200mg/day ) or 12-week CBT only .
METHODS	The primary outcome measure was treatment retention .
METHODS	Secondary outcomes included medication adherence , safety , cocaine and other substance use , health , social functioning , and patient satisfaction .
RESULTS	Adherence to topiramate treatment was low .
RESULTS	In the intent-to-treat analyses , topiramate neither improved treatment retention nor reduced cocaine and other substance use .
RESULTS	Post hoc , exploratory analyses suggested a moderation effect of comorbid opioid dependence , with a significant effect of topiramate on cocaine use reduction only in crack-cocaine dependent patients with comorbid opioid dependence .
CONCLUSIONS	Topiramate was safe and well-tolerated in this sample of crack-cocaine dependent patients , but efficacy was not supported probably due to low acceptance of the treatment .
CONCLUSIONS	Given the equivocal results of previous studies and the negative findings in our study , the potential of topiramate in the treatment of cocaine dependence seems limited .

###24733645
OBJECTIVE	Food portion size is an important determinant of intake in children .
OBJECTIVE	It remains unknown if children 's weight status and relative reinforcing value of food ( RRVF ) interact with portion size to affect intake .
METHODS	In a randomized crossover design , 25 normal-weight and 25 obese children , ages 8-10 years , consumed dinner once a week for 3 weeks .
METHODS	At each dinner , the same meal was served , but the portion size of all foods ( chicken nuggets , hash browns , ketchup , green beans , brownies ) and a sugar-sweetened beverage ( fruit punch ) varied across conditions ( 100 , 150 , and 200 % ) .
METHODS	Children 's RRVF was assessed using a behavioral choice task .
RESULTS	There was a significant main effect of portion size condition ( P = 0.003 ) and weight status ( P = 0.0005 ) and a nonsignificant trend for a portion size-by-weight status interaction ( P = 0.108 ) on intake .
RESULTS	Mean intakes across conditions ( 100 , 150 , and 200 % ) were 80157 , 96458 , and 87357 kcal for normal-weight children and 104157 , 112957 , and 121057 kcal for obese children , respectively .
RESULTS	Neither the main effect of RRVF status nor the condition-by-RRVF status interaction was significant ( P > 0.48 ) .
CONCLUSIONS	Environments that offer large portions of palatable foods affect all children 's intake irrespective of their weight status or how reinforcing they find food to be .

###24372937
OBJECTIVE	To examine the efficacy of a brief intervention delivered by a therapist ( TBI ) or a computer ( CBI ) in preventing cannabis use among adolescents in urban primary care clinics .
METHODS	A randomized controlled trial comparing : CBI and TBI versus control .
METHODS	Urban primary care clinics in the United States .
METHODS	Research staff recruited 714 adolescents ( aged 12-18 years ) who reported no life-time cannabis use on a screening survey for this study , which included a baseline survey , randomization ( stratified by gender and grade ) to conditions ( control ; CBI ; TBI ) and 3 - , 6 - and 12-month assessments .
METHODS	Using an intent-to-treat approach , primary outcomes were cannabis use ( any , frequency ) ; secondary outcomes included frequency of other drug use , severity of alcohol use and frequency of delinquency ( among 85 % completing follow-ups ) .
RESULTS	Compared with controls , CBI participants had significantly lower rates of any cannabis use over 12 months ( 24.16 % , 16.82 % , respectively , P < 0.05 ) , frequency of cannabis use at 3 and 6 months ( P < 0.05 ) and other drug use at 3 months ( P < 0.01 ) .
RESULTS	Compared with controls , TBI participants did not differ in cannabis use or frequency , but had significantly less other drug use at 3 months ( P < 0.05 ) , alcohol use at 6 months ( P < 0.01 ) and delinquency at 3 months ( P < 0.01 ) .
CONCLUSIONS	Among adolescents in urban primary care in the United States , a computer brief intervention appeared to prevent and reduce cannabis use .
CONCLUSIONS	Both computer and therapist delivered brief interventions appeared to have small effects in reducing other risk behaviors , but these dissipated over time .

###25847941
OBJECTIVE	Glycoprotein NMB ( gpNMB ) , a negative prognostic marker , is overexpressed in multiple tumor types .
OBJECTIVE	Glembatumumab vedotin is a gpNMB-specific monoclonal antibody conjugated to the potent cytotoxin monomethyl auristatin E.
OBJECTIVE	This phase II study investigated the activity of glembatumumab vedotin in advanced breast cancer by gpNMB expression .
METHODS	Patients ( n = 124 ) with refractory breast cancer that expressed gpNMB in 5 % of epithelial or stromal cells by central immunohistochemistry were stratified by gpNMB expression ( tumor , low stromal intensity , high stromal intensity ) and were randomly assigned 2:1 to glembatumumab vedotin ( n = 83 ) or investigator 's choice ( IC ) chemotherapy ( n = 41 ) .
METHODS	The study was powered to detect overall objective response rate ( ORR ) in the glembatumumab vedotin arm between 10 % ( null ) and 22.5 % ( alternative hypothesis ) with preplanned investigation of activity by gpNMB distribution and/or intensity ( Stratum 1 to Stratum 3 ) .
RESULTS	Glembatumumab vedotin was well tolerated as compared with IC chemotherapy ( less hematologic toxicity ; more rash , pruritus , neuropathy , and alopecia ) .
RESULTS	ORR was 6 % ( five of 83 ) for glembatumumab vedotin versus 7 % ( three of 41 ) for IC , without significant intertreatment differences for predefined strata .
RESULTS	Secondary end point revealed ORR of 12 % ( 10 of 83 ) versus 12 % ( five of 41 ) overall , and 30 % ( seven of 23 ) versus 9 % ( one of 11 ) for gpNMB overexpression ( 25 % of tumor cells ) .
RESULTS	Unplanned analysis showed ORR of 18 % ( five of 28 ) versus 0 % ( 0 of 11 ) in patients with triple-negative breast cancer ( TNBC ) , and 40 % ( four of 10 ) versus 0 % ( zero of six ) in gpNMB-overexpressing TNBC .
CONCLUSIONS	Glembatumumab vedotin is well tolerated in heavily pretreated patients with breast cancer .
CONCLUSIONS	Although the primary end point in advanced gpNMB-expressing breast cancer was not met for all enrolled patients ( median tumor gpNMB expression , 5 % ) , activity may be enhanced in patients with gpNMB-overexpressing tumors and/or TNBC .
CONCLUSIONS	A pivotal phase II trial ( METRIC [ Metastatic Triple-Negative Breast Cancer ] ) is underway .

###24268300
OBJECTIVE	Assess effectiveness of the Expanded Food and Nutrition Education Program on nutrition behaviors post-education and longitudinally .
METHODS	Switching replications randomized experimental design .
METHODS	Participants randomly assigned to immediate education ( IE ) or delayed education ( DE ) .
METHODS	Participants in IE received intervention the first 8 weeks , and those in DE the second 8 weeks , with no intervention during alternate periods .
METHODS	Data were collected in 3 repeated measures .
METHODS	Parents ( n = 168 randomized ; n = 134 completed ) of children in 2 Head Start and 6 low-income schools .
METHODS	Eight weekly workshops , based on Eating Right is Basic-Enhanced adapted to incorporate dialogue approach with experiential learning .
METHODS	Ten-item self-reported behavior checklist on nutrition , food resource management , food safety , and food security ; responses on a 5-point scale reporting frequency of behavior .
METHODS	Chi-square , analysis of variance , and multiple regression .
RESULTS	Groups were demographically similar .
RESULTS	Both groups reported improved behaviors pre - to post-education ( P < .05 ) .
RESULTS	There was no significant difference between groups at Time 1 ( T1 ) or DE control period ( T1 vs T2 ) .
RESULTS	Changed IE behavior was retained T2 to T3 .
RESULTS	A multiple regression model of overall change , controlling for T1 score and educator , showed significant improvement ( n = 134 , = 5.72 , P < .001 ) .
CONCLUSIONS	Positive outcomes were supported by this experimental study in a usual program context , with reported behavior changes retained at least 2 months .

###25758385
BACKGROUND	Healthcare worker attitudes toward obese individuals facilitate discrimination and contribute to poor health outcomes .
BACKGROUND	Previous studies have demonstrated medical student bias toward obese individuals , but few have examined effects of the educational environment on these prejudicial beliefs .
BACKGROUND	We sought to determine whether an innovative educational intervention ( reading a play about obesity ) could diminish obesity prejudice relative to a standard medical lecture .
METHODS	We conducted a randomized , controlled trial enrolling medical students ( n = 129 ) from three universities .
METHODS	Students were assigned to play-reading or a standard lecture .
METHODS	Explicit attitudes and implicit bias toward obese individuals were assessed prior to intervention and after four months .
RESULTS	At baseline , students demonstrated moderate explicit and implicit bias toward obese people despite high scores on empathy .
RESULTS	Students randomized to the play-reading group had significantly decreased explicit fat bias ( P = 0.01 ) at follow-up , while students in the lecture group showed increased endorsement of a prescriptive model of care at the expense of a patient-centered approach ( P = 0.03 ) .
RESULTS	There was a significant increase in empathy for those in both the theater ( P = 0.007 ) and lecture group ( P = 0.02 ) .
RESULTS	The intervention had no significant effect on implicit bias or regard for obesity as a civil rights issue .
CONCLUSIONS	Dramatic reading may be superior to traditional medical lectures for showcasing patient rights and preferences .
CONCLUSIONS	The present study demonstrates for the first time that play-reading diminishes conscious obesity bias .
CONCLUSIONS	Further research should determine whether nontraditional methods of instruction promote improved understanding of and care for obese patients .

###24268631
OBJECTIVE	To compare the thrombosis rate , ease of insertion , bleeding rate , and complications of a nontapered peripherally inserted central catheter ( PICC ) versus a reverse tapered PICC .
METHODS	This was a prospective randomized , controlled trial conducted in single center .
METHODS	All patients 18-90 years old requiring PICC insertion were considered for the study .
METHODS	All patients were followed until PICC removal .
METHODS	Ultrasound examination of the arm was performed at PICC removal or at 28 days .
METHODS	There were 332 patients randomly assigned -- 164 to the nontapered PICC group and 168 to the reverse tapered PICC group .
RESULTS	The overall thrombosis rate was 71.9 % .
RESULTS	The thrombosis rate was 70.4 % in the nontapered PICC group and 73.4 % in the reverse tapered PICC group ( P = .58 ) .
RESULTS	The symptomatic thrombosis rate was 4.3 % in the nontapered PICC group and 3.6 % in the reverse tapered PICC group ( P = .75 ) .
RESULTS	The complete thrombosis rate was 15.6 % in the nontapered PICC group compared with 20.8 % in the reverse tapered PICC group ( P = .44 ) .
RESULTS	There was a statistically significantly higher thrombosis rate in patients with cancer ( 71.9 % vs 66.7 % , P = .002 ) .
CONCLUSIONS	This study showed a high incidence of thrombosis of peripheral veins used for PICC insertion .
CONCLUSIONS	The implication of this thrombosis is significant in light of the morbidity and potential mortality associated with this condition .
CONCLUSIONS	A difference in thrombosis rate between devices could not be detected in this study .

###24822382
BACKGROUND	Four-layer bandaging is the standard treatment for venous leg ulcers but is bulky and can restrict mobility .
BACKGROUND	Two-layer compression stockings have recently been marketed but their clinical and cost effectiveness were unknown .
OBJECTIVE	To compare the clinical and cost effectiveness of four-layer bandaging with two-layer compression stockings .
METHODS	In a pragmatic , open , randomised controlled trial 454 participants were randomly allocated two-layer compression stockings or four-layer bandages and followed for up to 12 months after healing .
RESULTS	The median time to ulcer healing was almost identical ( stockings group : 99 days , bandaging group : 98 days ) .
RESULTS	More patients allocated stockings changed treatment but ulcer recurrence rates were higher in the bandaging group .
RESULTS	Stockings cost 302 sterling pounds less per participant per year and had more than 95 % probability of being the most cost-effective treatment .
CONCLUSIONS	Two-layer compression stockings are a viable , cost-effective alternative to four-layer bandaging but may not be suitable for all patients .

###25500317
OBJECTIVE	The approved use of onabotulinumtoxinA for prophylaxis of headaches in patients with chronic migraine ( CM ) involves treatment every 12weeks .
OBJECTIVE	It is currently unknown whether patients who fail to respond to the first onabotulinumtoxinA treatment cycle will respond to subsequent treatment cycles .
OBJECTIVE	To help inform decisions about treating non-responders , we examined the probability of treatment cycle 1 non-responders responding in cycle 2 , and cycle 1 and 2 non-responders responding in cycle 3 .
METHODS	Pooled PREEMPT data ( two studies : a 24-week , 2-cycle , double-blind , randomised ( 1:1 ) , placebo-controlled , parallel-group phase , followed by a 32-week , 3-cycle , open-label phase ) evaluated onabotulinumtoxinA ( 155-195U ) for prophylaxis of headaches in persons with CM ( 15days/month with headache 4h/day ) .
METHODS	End points of interest included the proportion of study patients who first achieved a 50 % reduction in headache days , moderate/severe headache days , total cumulative hours of headache on headache days , or a 5-point improvement in Headache Impact Test ( HIT ) -6 .
METHODS	For treatment cycle 1 , all eligible participants were included .
METHODS	For subsequent cycles , responders in a previous cycle were no longer considered first responders .
RESULTS	Among onabotulinumtoxinA-treated patients ( n = 688 ) 49.3 % had a 50 % reduction in headache-day frequency during treatment cycle 1 , with 11.3 % and 10.3 % of patients first responding during cycles 2 and 3 , respectively .
RESULTS	54.2 % , 11.6 % and 7.4 % of patients first responded with a 50 % reduction in cumulative hours of headache , and 56.3 % , 14.5 % and 7.7 % of patients first responded with a 5-point improvement in total HIT-6 during treatment cycles 1 , 2 and 3 , respectively .
CONCLUSIONS	A meaningful proportion of patients with CM treated with onabotulinumtoxinA who did not respond to the first treatment cycle responded in the second and third cycles of treatment .
BACKGROUND	NCT00156910 , NCT00168428 .

###24359285
BACKGROUND	Unhealthy lifestyles contribute to the development of cardiovascular risk factors , whose incidence is increasing among children and adolescents .
BACKGROUND	The Program SI !
BACKGROUND	is a long-term , multi-target behavioral intervention to promote healthy lifestyle habits in children through the school environment .
BACKGROUND	The objective of the study is to evaluate the efficacy of this intervention in its first phase , preschoolers .
METHODS	Cluster-randomized controlled trial in public schools in the city of Madrid , Spain .
METHODS	A total 24 schools , including 2062 children ( 3-5 years ) , 1949 families , and 125 teachers participated in the study .
METHODS	Schools were assigned to their usual school curriculum or to engage in an additional multi-component intervention ( Program SI ! )
METHODS	The primary outcome of this trial is 1-school year changes from baseline in scores for children 's knowledge , attitudes and habits ( KAH ) .
METHODS	Secondary outcomes are 1-school year changes from baseline in scores for knowledge , attitudes , and habits among parents , teachers , and the school environment .
RESULTS	After 1-school year , our results indicate that the Program SI !
RESULTS	intervention increases children 's KAH scores , both overall ( 3.45 , 95 % CI , 1.84-5 .05 ) and component-specific ( Diet : 0.93 , 95 % CI , 0.12-1 .75 ; Physical activity : 1.93 , 95 % CI , 1.17-2 .69 ; Human body : 0.65 , 95 % CI , 0.07-1 .24 ) score .
CONCLUSIONS	The Program SI !
CONCLUSIONS	is demonstrated as an effective and feasible strategy for increasing knowledge and improving lifestyle attitudes and habits among very young children .
BACKGROUND	NCT01579708 , Evaluation of the Program SI !
BACKGROUND	for Preschool Education : A School-Based Randomized Controlled Trial ( Preschool-SI ! )

###24462785
BACKGROUND	The Juglans regia L. leaf has been traditionally used for treatment of diabetes mellitus in Iran .
BACKGROUND	But yet , no controlled human study has determined its efficacy in diabetic patients .
BACKGROUND	The present study was designed to investigate the effects of the Juglans regia leaf extract on hyperglycemia and lipid profiles in type II diabetic patients .
METHODS	Total 61 patients , suffering from type II diabetes with fasting blood glucose ( FBG ) between 150 and 200mg/dL , glycated hemoglobin ( HbA1c ) between 7 % and 9 % and aged between 40 and 60 years were selected , and randomly divided in to two groups of Juglans regia and placebo .
METHODS	First group received 100mg Juglans regia leaf extract in capsules form two times a day for 3 months and other group received 100mg placebo capsule with the same dosage .
METHODS	The standard anti-diabetic therapy ( metformin and glibenclamide , and nutritional regimen ) was continued in both groups .
METHODS	At the baseline and after three months the FBG , insulin , HbA1c , cholesterol , triglyceride , HDL , LDL and liver and renal function tests were determined .
METHODS	In addition general satisfaction with the treatment was identified using health questionnaires .
RESULTS	The results indicated that FBG , HbA1c , total cholesterol and triglyceride levels in Juglans regia treated patients significantly decreased compared with the baseline and with placebo group .
RESULTS	Patients in Juglans regia group were significantly satisfied with Juglans regia treatment compared with the placebo group .
RESULTS	No liver , kidney and other side effects were observed in the groups , except more GI events ( specially a mild diarrhea ) associated with extract treatment at the beginning of the study .
CONCLUSIONS	In conclusion , treatment of type II diabetic patients with 100mg Juglans regia leaf extract two times a day for three months improves lipid profile and glycemic control without any tangible adverse effects .

###24905134
BACKGROUND	The use of tissue adhesives for the closure of surgical incisions is increasing .
BACKGROUND	Few studies directly compare tissue adhesives to one another or focus on the difference in wound closure time between tissue adhesives .
BACKGROUND	We compared the use of N-butyl-2 cyanoacrylate ( Histoacryl ) , octyl cyanoacrylate ( Dermabond ) , or subcuticular suture in incisions resulting from reduction mammoplasty , mastopexy , panniculectomy , and abdominoplasty .
METHODS	A 2-armed prospective randomized controlled trial was performed .
METHODS	Part 1 compared closure of surgical incisions with N-butyl-2 cyanoacrylate and octyl cyanoacrylate .
METHODS	Part 2 compared the closure of surgical incisions with N-butyl-2 cyanoacrylate and subcuticular suture .
METHODS	End points were closure time , scar width , and satisfaction ratings .
RESULTS	Both study arms revealed significantly faster closer times with N-butyl-2 cyanoacrylate [ 9/10 in part 1 ( P = 0.022 ) and 10/10 in part 2 ( P = 0.002 ) ] .
RESULTS	Scar width difference did not reach statistical significance , and there was no difference in surgeon , independent reviewer , or patient satisfaction among the materials .
CONCLUSIONS	Our results demonstrate a decreased time required for wound closure using N-butyl-2 cyanoacrylate compared to both suture and octyl cyanoacrylate regardless of incision type with no significant difference in scar width or satisfaction ratings .

###24630820
OBJECTIVE	To evaluate the effect of burn rehabilitation massage therapy on hypertrophic scar after burn .
METHODS	One hundred and forty-six burn patients with hypertrophic scar ( s ) were randomly divided into an experimental group and a control group .
METHODS	All patients received standard rehabilitation therapy for hypertrophic scars and 76 patients ( massage group ) additionally received burn scar rehabilitation massage therapy .
METHODS	Both before and after the treatment , we determined the scores of visual analog scale ( VAS ) and itching scale and assessed the scar characteristics of thickness , melanin , erythema , transepidermal water loss ( TEWL ) , sebum , and elasticity by using ultrasonography , Mexameter ( ) , Tewameter ( ) , Sebumeter ( ) , and Cutometer ( ) , respectively .
RESULTS	The scores of both VAS and itching scale decreased significantly in both groups , indicating a significant intragroup difference .
RESULTS	With regard to the scar characteristics , the massage group showed a significant decrease after treatment in scar thickness , melanin , erythema , TEWL and a significant intergroup difference .
RESULTS	In terms of scar elasticity , a significant intergroup difference was noted in immediate distension and gross skin elasticity , while the massage group significant improvement in skin distensibility , immediate distension , immediate retraction , and delayed distension .
CONCLUSIONS	Our results suggest that burn rehabilitation massage therapy is effective in improving pain , pruritus , and scar characteristics in hypertrophic scars after burn .

###24460860
BACKGROUND	This study examined how well students estimate their overall drinker type and the relation between the accuracy of this estimation with alcohol-related consequences .
BACKGROUND	The study also explored the association between psychosocial alcohol variables and underestimation or overestimation of drinker type .
METHODS	College students ( n = 1,895 ) completed questionnaires at baseline ( precollege matriculation ) assessing self-reported drinker types ( SI ) , protective and risky drinking behaviors , drinking expectancies , attitudes , and norms .
METHODS	Postbaseline assessment occurred during the fall semester sophomore year and included the number and type of alcohol consequences experienced during the previous year .
METHODS	Students ' SIs were coded as accurate , overestimated , or underestimated relative to their empirically derived latent class analytic drinker class .
METHODS	The association between drinker type accuracy and consequences and membership in the high-risk Multiple and Repeated Consequence group was assessed , as was the relationship between the psychosocial alcohol variables and accuracy .
RESULTS	Eighteen percent of students underestimated and 10 % overestimated their drinker type .
RESULTS	Students who under - or overestimated their drinker type reported experiencing more consequences , even after controlling for drinking .
RESULTS	Increases in positive alcohol expectancies , protective and risky drinking behaviors , and descriptive peer norms were positively associated with underestimation of drinker type .
RESULTS	Only protective and risky drinking behaviors were associated with overestimation .
CONCLUSIONS	This study underscores the importance of accurate estimation of drinker type and the risk of experiencing alcohol consequences .
CONCLUSIONS	Future research and intervention strategies are discussed .

###24512390
BACKGROUND	Detection of clinically relevant pain relief in cats with degenerative joint disease ( DJD ) is complicated by a lack of validated outcome measures and a placebo effect .
OBJECTIVE	To evaluate a novel approach for detection of pain relief in cats with DJD .
METHODS	Fifty-eight client-owned cats .
METHODS	Prospective , double-masked , placebo-controlled , stratified , randomized , clinical study .
METHODS	Enrolled cats were 6-21years of age , with owner-observed mobility impairment , evidence of pain in at least 2 joints during orthopedic examination , and overlapping radiographic evidence of DJD , and underwent a 2-week baseline period , 3-week treatment period with placebo or meloxicam , and 3-week masked washout period .
METHODS	Outcome measures were evaluated at days 0 , 15 , 36 , and 57 .
RESULTS	Both groups significantly improved after the treatment period ( day 36 ) on client-specific outcome measures ( CSOM ) and feline musculoskeletal pain index ( FMPI ) ( P < .0001 for both ) ; there was no difference between the groups on CSOM or FMPI score improvement .
RESULTS	After the masked washout period , more cats that received meloxicam during the treatment period had a clinically relevant decrease in CSOM score ( P = .048 ) and FMPI score ( P = .021 ) than cats that received placebo .
CONCLUSIONS	Using both a client-specific and a general clinical metrology instrument , owners of cats with DJD were able to detect evident recurrence of clinical signs after withdrawal of active medication than after withdrawal of placebo , and that this study design might be a novel and useful way to circumvent the placebo effect and detect the efficacy of pain-relieving medications .

###24360106
OBJECTIVE	To evaluate the efficacy of continuous wound infusion of ropivacaine for postoperative pain relief after open hepatectomy .
METHODS	From May 2011 to December 2012 , 60 patients undergoing open hepatectomy were randomized into normal saline continuous infusion group ( n = 30 ) and 0.3 % ropivacaine continuous infusion group ( n = 30 ) .
METHODS	The following variables were recorded for the 48 hours postoperatively : pain scores at rest and sedation score every 8 hours , total sufentanil consumption , first postoperative bowel movement , length of hospitalization , nausea and vomiting score , liver function change and other adverse events were also recorded .
RESULTS	Pain scores at rest were lower for the ropivacaine group and reached significance after 8 h ( all P < 0.05 ) .
RESULTS	The values of sufentanil consumption ( ( 43.8 21.8 ) vs ( 78.2 35.2 ) g , P < 0.01 ) , time to bowel recovery ( ( 1.2 0.4 ) vs ( 1.5 0.5 ) days , P < 0.01 ) and mean length of hospitalization ( ( 6.1 2.6 ) vs ( 7.6 2.9 ) days , P < 0.05 ) decreased significantly .
RESULTS	Sedation score and liver function recovery were better in ropivacaine group .
RESULTS	No surgical wound infection occurred in either group .
CONCLUSIONS	Surgical wound infusion with ropivacaine is safe and effective .
CONCLUSIONS	And it improves postoperative pain relief and accelerates patients recovery and discharge with less damage to liver function .

###25253539
BACKGROUND	Preliminary findings suggest that Web-based interventions may be effective in achieving significant smoking cessation .
BACKGROUND	To date , very few findings are available for primary care patients , and especially for the involvement of general practitioners .
OBJECTIVE	Our goal was to examine the short-term effectiveness of a fully automated Web-based coaching program in combination with accompanied telephone counseling in smoking cessation in a primary care setting .
METHODS	The study was an unblinded cluster-randomized trial with an observation period of 12 weeks .
METHODS	Individuals recruited by general practitioners randomized to the intervention group participated in a Web-based coaching program based on education , motivation , exercise guidance , daily short message service ( SMS ) reminding , weekly feedback through Internet , and active monitoring by general practitioners .
METHODS	All components of the program are fully automated .
METHODS	Participants in the control group received usual care and advice from their practitioner without the Web-based coaching program .
METHODS	The main outcome was the biochemically confirmed smoking status after 12 weeks .
RESULTS	We recruited 168 participants ( 86 intervention group , 82 control group ) into the study .
RESULTS	For 51 participants from the intervention group and 70 participants from the control group , follow-up data were available both at baseline and 12 weeks .
RESULTS	Very few patients ( 9.8 % , 5/51 ) from the intervention group and from the control group ( 8.6 % , 6/70 ) successfully managed smoking cessation ( OR 0.86 , 95 % CI 0.25-3 .0 ; P = .816 ) .
RESULTS	Similar results were found within the intent-to-treat analysis : 5.8 % ( 5/86 ) of the intervention group and 7.3 % ( 6/82 ) of the control group ( OR 1.28 , 95 % CI 0.38-4 .36 ; P = .694 ) .
RESULTS	The number of smoked cigarettes per day decreased on average by 9.3 in the intervention group and by 6.6 in the control group ( 2.7 mean difference ; 95 % CI -5.33 to -0.58 ; P = .045 ) .
RESULTS	After adjustment for the baseline value , age , gender , and height , this significance decreases ( mean difference 2.2 ; 95 % CI -4.7 to 0.3 ; P = .080 ) .
CONCLUSIONS	This trial did not show that the tested Web-based intervention was effective for achieving smoking cessation compared to usual care .
CONCLUSIONS	The limited statistical power and the high drop-out rate may have reduced the study 's ability to detect significant differences between the groups .
CONCLUSIONS	Further randomized controlled trials are needed in larger populations and to investigate the long-term outcome .
BACKGROUND	German Register for Clinical Trials , registration number DRKS00003067 ; http://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ ID = DRKS00003067 ( Archived by WebCite at http://www.webcitation.org/6Sff1YZpx ) .

###25035205
OBJECTIVE	To propose a random forest normal tissue complication probability ( RF-NTCP ) model to predict late rectal toxicity following prostate cancer radiation therapy , and to compare its performance to that of classic NTCP models .
METHODS	Clinical data and dose-volume histograms ( DVH ) were collected from 261 patients who received 3-dimensional conformal radiation therapy for prostate cancer with at least 5 years of follow-up .
METHODS	The series was split 1000 times into training and validation cohorts .
METHODS	A RF was trained to predict the risk of 5-year overall rectal toxicity and bleeding .
METHODS	Parameters of the Lyman-Kutcher-Burman ( LKB ) model were identified and a logistic regression model was fit .
METHODS	The performance of all the models was assessed by computing the area under the receiving operating characteristic curve ( AUC ) .
RESULTS	The 5-year grade 2 overall rectal toxicity and grade 1 and grade 2 rectal bleeding rates were 16 % , 25 % , and 10 % , respectively .
RESULTS	Predictive capabilities were obtained using the RF-NTCP model for all 3 toxicity endpoints , including both the training and validation cohorts .
RESULTS	The age and use of anticoagulants were found to be predictors of rectal bleeding .
RESULTS	The AUC for RF-NTCP ranged from 0.66 to 0.76 , depending on the toxicity endpoint .
RESULTS	The AUC values for the LKB-NTCP were statistically significantly inferior , ranging from 0.62 to 0.69 .
CONCLUSIONS	The RF-NTCP model may be a useful new tool in predicting late rectal toxicity , including variables other than DVH , and thus appears as a strong competitor to classic NTCP models .

###25433470
OBJECTIVE	A randomized clinical trial was designed to compare the efficacy , success rate and surgical complications of percutaneous nephrolithotomy ( PCNL ) and laparoscopic pyelolithotomy ( LP ) .
METHODS	Sixty patients with renal pelvic stones larger than 2 cm were randomly divided into two groups of LP and PCNL .
METHODS	All patients were followed up to three months after surgery using renal diethylenetriamine?pentaaceticacid ( DTPA ) scan and determining the glomerular filtration rate ( GFR ) .
RESULTS	Mean operation time ( 149 ?
RESULTS	31 vs. 107 ?
RESULTS	26 min ) and mean hospital stay ( 3.4 vs. 2.16 days ) were significantly higher in LP , but mean hemoglobin drop ( 0.85 vs. 1.88 g/dL ) and the rate of blood transfusion were significantly lower .
RESULTS	Stone free rate was 90 % and 86.6 % for LP and PCNL , respectively ( P = .59 ) , while the changes in GFR were not statistically significant 3 days after surgery between two groups .
RESULTS	Those in LP group showed better improvement in GFR at three months postoperatively .
RESULTS	Improvement of the affected split kidney function was significantly higher in LP group ( P = .04 ) .
RESULTS	No major complications were observed in both groups according to Clavien grading system .
CONCLUSIONS	PCNL remains the gold standard treatment for most large kidney stones , nevertheless , laparoscopic pyelolithotomy can be considered for selected cases especially in whom maximal preservation of renal function is ?
CONCLUSIONS	necessary .

###25352018
OBJECTIVE	To examine the long-term prevalence and predictors of weekly urinary incontinence in the Diabetes Prevention Program Outcomes Study , a follow-up study of the Diabetes Prevention Program randomized clinical trial of overweight adults with impaired glucose tolerance .
METHODS	This analysis included 1778 female participants of the Diabetes Prevention Program Outcomes Study who had been randomly assigned during the Diabetes Prevention Program to intensive lifestyle intervention ( n = 582 ) , metformin ( n = 589 ) or placebo ( n = 607 ) .
METHODS	The study participants completed semi-annual assessments after the final Diabetes Prevention Program visit and for 6years until October 2008 .
RESULTS	At the study entry , the prevalence of weekly urinary incontinence was lower in the intensive lifestyle intervention group compared with the metformin and placebo groups ( 44.2 % vs 51.8 % , 48.0 % urinary incontinence/week , P = 0.04 ) ; during the 6-year follow-up period , these lower rates in intensive lifestyle intervention were maintained ( 46.7 % , 53.1 % , 49.9 % urinary incontinence/week ; P = 0.03 ) .
RESULTS	Statistically adjusting for urinary incontinence prevalence at the end of the Diabetes Prevention Program , the treatment arm no longer had a significant impact on urinary incontinence during the Diabetes Prevention Program Outcomes Study .
RESULTS	Independent predictors of lower urinary incontinence during the Diabetes Prevention Program Outcomes Study included lower body mass index ( odds ratio 0.988 , 95 % confidence interval 0.982-0 .994 ) and greater physical activity ( odds ratio 0.999 , 95 % confidence interval 0.998-1 .000 ) at the Diabetes Prevention Program Outcomes Study entry , and greater reductions in body mass index ( odds ratio 0.75 , 95 % confidence interval 0.60-0 .94 ) and waist circumference ( odds ratio 0.998 , 95 % confidence interval 0.996-1 .0 ) during the Diabetes Prevention Program Outcomes Study .
RESULTS	Diabetes was not significantly related to urinary incontinence .
CONCLUSIONS	Intensive lifestyle intervention has a modest positive and enduring impact on urinary incontinence , and should be considered for the long-term prevention and treatment of urinary incontinence in overweight/obese women with glucose intolerance .

###24661681
BACKGROUND	Motor impairment is a major consequence of spinal cord injury ( SCI ) .
BACKGROUND	Earlier studies have shown that robotic gait orthosis ( e.g. , Lokomat ) can improve an SCI individual 's walking capacity .
BACKGROUND	However , little is known about the differential responses among different individuals with SCI .
BACKGROUND	The present longitudinal study sought to characterize the distinct recovery patterns of gait impairment for SCI subjects receiving Lokomat training , and to identify significant predictors for these patterns .
METHODS	Forty SCI subjects with spastic hypertonia at their ankles were randomly allocated to either control or intervention groups .
METHODS	Subjects in the intervention group participated in twelve 1-hour Lokomat trainings over one month , while control subjects received no interventions .
METHODS	Walking capacity was evaluated in terms of walking speed , functional mobility , and endurance four times , i.e. baseline , 1 , 2 , and 4 weeks after training , using the 10-Meter-Walking , Timed-Up-and-Go , and 6-Minute-Walking tests .
METHODS	Growth Mixture Modeling , an analytical framework for stratifying subjects based on longitudinal changes , was used to classify subjects , based on their gait impairment recovery patterns , and to identify the effects of Lokomat training on these improvements .
RESULTS	Two recovery classes ( low and high walking capacity ) were identified for each clinical evaluation from both the control and intervention groups .
RESULTS	Subjects with initial high walking capacity ( i.e. shorter Timed-Up-and-Go time , higher 10-Meter-Walking speed and longer 6-Minute-Walking distance ) displayed significant improvements in speed and functional mobility ( 0.033 m/s/week and-0 .41 s/week respectively ) ; however no significant change in endurance was observed .
RESULTS	Subjects with low walking capacity exhibited no significant improvement .
RESULTS	The membership in these two classes-and thus prediction of the subject 's gait improvement trajectory over time-could be determined by the subject 's maximum voluntary torque at the ankle under both plantar-and dorsi-flexion contractions determined prior to any training .
CONCLUSIONS	Our findings demonstrate that subjects responded to Lokomat training non-uniformly , and should potentially be grouped based on their likely recovery patterns using objective criteria .
CONCLUSIONS	Further , we found that the subject 's ankle torque can predict whether he/she would benefit most from Lokomat training prior to the therapy .
CONCLUSIONS	These findings are clinically significant as they can help individualize therapeutic programs that maximize patient recovery while minimizing unnecessary efforts and costs .

###24859122
OBJECTIVE	This study was to develop a breastfeeding promotion program and to test effects of the program on levels of breast discomfort , breast size , sodium in breast milk , and type of feeding in mothers with breast engorgement following cesarean birth .
METHODS	A non-synchronized non-equivalent control group pretest-posttest design was used in this study .
METHODS	The participants were 70 postpartum mothers who were admitted to a postpartum care center and experienced breast engorgement following cesarean birth .
METHODS	The planned nursing intervention was the breastfeeding promotion program consisting of breast massage and 1:1 breastfeeding education , counseling , and support focusing on individualized problem solving provided for 10 days .
METHODS	Fifty-three women completed the program ( experimental group 26 , control group , 27 ) .
METHODS	Measurements were level of breast discomfort , breast size , sodium in breast milk and type of feeding at pre and posttest .
RESULTS	Women who participated in the program experienced lower scores for breast discomfort , greater decrease in breast size , lower levels of sodium in breast milk , and practiced breastfeeding more than those in the control group .
CONCLUSIONS	Results indicate that this breastfeeding promotion program is effective in reducing breast engorgement and improving breastfeeding practices , and is therefore recommended to enhance breastfeeding promotion practice in postpartum care centers .

###24327421
OBJECTIVE	The purpose of this study was to evaluate the 1-year clinical outcomes of more complex XIENCE V USA real-world patients with small versus nonsmall vessel lesions .
BACKGROUND	Patients with small vessel lesions undergoing coronary stent placement are at higher risk of major adverse cardiac events .
BACKGROUND	Improved safety and efficacy of XIENCE V everolimus eluting stents ( EES ) have been previously demonstrated in selected low-risk small vessel populations in randomized clinical trials .
METHODS	The XIENCE V USA study was a condition of approval , single-arm study in unselected real-world patients .
METHODS	Baseline and 1-year clinical outcomes were compared between XIENCE V USA patients who received a single 2.5 mm stent ( small vessel group , N = 838 ) and patients implanted with a single > 2.5 mm stent ( non-small vessel group , N = 2,015 ) .
METHODS	Mean reference vessel diameter was 2.550.36 and 3.250.46 mm in the small and non-small vessel groups , respectively ( P < 0.001 ) .
RESULTS	Small vessel group had more females , presented with a higher rate of diabetes , and had more complex lesion characteristics .
RESULTS	The definite or probable ST rates analyzed using Kaplan-Meier method were low and not significantly different between the groups at 0.37 and 0.40 % for the small and nonsmall vessel group ( P = 0.88 ) , respectively .
RESULTS	The composite rate of cardiac death or MI was comparable at 4.5 % for the small and 5.1 % for the non-small vessel 1 groups ( P = 0.57 ) .
RESULTS	The 1-year target lesion revascularization rate was also comparable in the small vessel group ( 3.8 % vs. 3.0 % , P = 0.35 ) .
CONCLUSIONS	Despite gender difference , higher prevalence of diabetes and more complex lesions in the small vessel groups , the 1-year clinical outcomes were similar in both small and nonsmall vessel groups .
CONCLUSIONS	These results demonstrate the therapeutic benefit of XIENCE V EES in a real-world all inclusive patient population with small vessel disease .

###25098557
BACKGROUND	This pilot study examined whether the addition of a normal protein ( NP ) vs. high protein ( HP ) breakfast leads to alterations in food cravings and plasma homovanillic acid ( HVA ) , which is an index of central dopamine production , in overweight/obese ` breakfast skipping ' late-adolescent young women .
METHODS	A randomized crossover design was incorporated in which 20 girls ( age 191 y ; BMI 28.60.7 kg/m2 ) consumed 350kcal NP ( 13g protein ) breakfast meals , 350kcal HP ( 35g protein ) breakfast meals , or continued breakfast skipping ( BS ) for 6 consecutive days/pattern .
METHODS	On day 7 of each pattern , a 4h testing day was completed including the consumption of breakfast ( or no breakfast ) followed by food craving questionnaires and blood sampling for HVA concentrations throughout the morning .
RESULTS	Both breakfast meals reduced post-meal cravings for sweet and savory foods and increased HVA concentrations vs. BS ( all , p < 0.05 ) .
RESULTS	Between breakfast meals , the HP breakfast tended to elicit greater reductions in post-meal savory cravings vs. NP ( p = 0.08 ) and tended to elicit sustained increases in HVA concentrations prior to lunch vs. NP ( p = 0.09 ) .
RESULTS	Lastly , HVA concentrations were positively correlated with the protein content at breakfast ( r : 0.340 ; p < 0.03 ) .
CONCLUSIONS	Collectively , these findings suggest that the addition of breakfast reduces post-meal food cravings and increases homovanillic acid concentrations in overweight/obese young people with higher protein versions eliciting greater responses .

###25613351
BACKGROUND	Deep brain stimulation ( DBS ) is an effective treatment for patients with advanced Parkinson 's disease ( PD ) and motor symptom complications .
BACKGROUND	Recently , attention has been focused on whether offering DBS earlier in the course of PD is beneficial .
OBJECTIVE	The purpose of this study was to determine the effects of DBS on neuropsychological functioning in subjects with early stage PD .
METHODS	Thirty subjects with early PD ( Hoehn & Yahr Stage II off medication ) were randomized to optimal drug therapy ( ODT ) ( n = 15 ) or bilateral subthalamic nucleus ( STN ) DBS+ODT ( n = 15 ) after completing an expanded informed consent process specially designed for the study and administered by a medical ethicist and the study team .
METHODS	Comprehensive neuropsychological testing was completed in the treatment-withdrawn state at baseline and at 12 month and 24 month follow-ups .
RESULTS	Two serious adverse events occurred in the DBS+ODT group .
RESULTS	One subject experienced a stroke and another developed infected hardware that contributed to specific declines in cognitive functioning .
RESULTS	However , compared to the ODT group , the remaining subjects in the DBS+ODT group exhibited modest reductions on a few measures of attention , executive function , and word fluency at 12 months .
RESULTS	These differences were largely diminished at 24 months , especially when those with the adverse events were excluded .
CONCLUSIONS	The results of this trial provide novel data regarding the effects of DBS on cognitive function in early PD .
CONCLUSIONS	We believe that the findings and insights from this trial can help guide the safety analysis and risk-benefit evaluations in future discussions of DBS in early stage PD .

###24411656
BACKGROUND	The literature suggests that people delay too long prior to attending emergency departments with acute coronary syndrome ( ACS ) symptoms .
BACKGROUND	This delay is referred to as prehospital delay .
BACKGROUND	Patient decision delay contributes most significantly to prehospital delay .
OBJECTIVE	Using a randomized controlled trial , we tested an educational intervention to reduce patient prehospital delay in ACS and promote appropriate responses to symptoms .
METHODS	Eligible patients who were admitted across five emergency departments ( EDs ) in Dublin were recruited to the study ( n = 1944 ; control : 972 , intervention : 972 ) .
RESULTS	Median baseline prehospital delay times did not differ significantly between the groups at baseline ( Mann-Whitney U , p = 0.34 ) ( CONTROL : 4.28 h , 25 ( th ) percentile = 1.71 , 75 ( th ) percentile = 17.37 ; Intervention 3.96 h , 25 ( th ) percentile = 1.53 , 75 ( th ) percentile = 18.51 ) .
RESULTS	Both groups received usual in-hospital care .
RESULTS	In addition , patients randomized to the intervention group received a 40-min individualized education session using motivational techniques .
RESULTS	This was reinforced 1 month later by telephone .
RESULTS	Of the 1944 , 314 ( 16.2 % ) were readmitted with ACS symptoms : 177 ( 18.2 % ) and 137 ( 14.1 % ) of the intervention and control groups , respectively .
RESULTS	Prehospital delay times were again measured .
RESULTS	Median delay time was significantly lower in the intervention compared to the control group ( 1.7 h vs. 7.1 h ; p 0.001 ) .
RESULTS	Appropriately , those in the intervention group reported their symptoms more promptly to another person ( p = 0.01 ) and fewer consulted a general practitioner ( p = 0.02 ) .
RESULTS	There was no significant difference in ambulance use ( p = 0.51 ) or nitrate use ( p = 0.06 ) between the groups .
CONCLUSIONS	It is possible to reduce prehospital delay time in ACS , but the need for renewed emphasis on ambulance use is important .

###25052847
BACKGROUND	Central disinhibition is a mechanism involved in the physiopathology of fibromyalgia .
BACKGROUND	Melatonin can improve sleep quality , pain and pain threshold .
BACKGROUND	We hypothesized that treatment with melatonin alone or in combination with amitriptyline would be superior to amitriptyline alone in modifying the endogenous pain-modulating system ( PMS ) as quantified by conditional pain modulation ( CPM ) , and this change in CPM could be associated with serum brain-derived neurotrophic factor ( BDNF ) .
BACKGROUND	We also tested whether melatonin improves the clinical symptoms of pain , pain threshold and sleep quality .
METHODS	Sixty-three females , aged 18 to 65 , were randomized to receive bedtime amitriptyline ( 25 mg ) ( n = 21 ) , melatonin ( 10 mg ) ( n = 21 ) or melatonin ( 10 mg ) + amitriptyline ( 25 mg ) ( n = 21 ) for a period of six weeks .
METHODS	The descending PMS was assessed with the CPM-TASK .
METHODS	It was assessed the pain score on the Visual Analog Scale ( VAS 0-100 mm ) , the score on Fibromyalgia Impact Questionnaire ( FIQ ) , heat pain threshold ( HPT ) , sleep quality and BDNF serum .
METHODS	Delta values ( post - minus pre-treatment ) were used to compare the treatment effect .
METHODS	The outcomes variables were collected before , one and six weeks after initiating treatment .
RESULTS	Melatonin alone or in combination with amitriptyline reduced significantly pain on the VAS compared with amitriptyline alone ( P < 0.01 ) .
RESULTS	The delta values on the VAS scores were-12 .85 ( 19.93 ) , -17.37 ( 18.69 ) and-20 .93 ( 12.23 ) in the amitriptyline , melatonin and melatonin + amitriptyline groups , respectively .
RESULTS	Melatonin alone and in combination increased the inhibitory PMS as assessed by the Numerical Pain Scale [ NPS ( 0-10 ) ] reduction during the CPM-TASK : -2.4 ( 2.04 ) melatonin + amitriptyline,-2 .65 ( 1.68 ) melatonin , and-1 .04 ( 2.06 ) amitriptyline , ( P < 0.05 ) .
RESULTS	Melatonin + amitriptyline treated displayed better results than melatonin and amitriptyline alone in terms of FIQ and PPT improvement ( P < 0.05 , fort both ) .
CONCLUSIONS	Melatonin increased the inhibitory endogenous pain-modulating system as assessed by the reduction on NPS ( 0-10 ) during the CPM-TASK .
CONCLUSIONS	Melatonin alone or associated with amitriptyline was better than amitriptyline alone in improving pain on the VAS , whereas its association with amitriptyline produced only marginal additional clinical effects on FIQ and PPT .
BACKGROUND	Current controlled trail is registered at clinical trials.gov upon under number NCT02041455 .
BACKGROUND	Registered January 16 , 2014 .

###24589538
OBJECTIVE	Results of a study to determine potential cost benefits of substituting an alternative electrolyte solution for 0.9 % sodium chloride injection for the initial fluid resuscitation of trauma patients are presented .
METHODS	Using data from a randomized clinical trial that compared 24-hour fluid resuscitation outcomes in critically injured trauma patients treated with 0.9 % sodium chloride injection and those who received a balanced electrolyte solution ( Plasma-Lyte A , Baxter Healthcare ) , a cost-minimization analysis was performed at a large medical center .
METHODS	The outcomes evaluated included fluid and drug acquisition costs , materials and nurse labor costs , and costs associated with electrolyte replacement .
RESULTS	The use of Plasma-Lyte A was associated with a relatively higher fluid acquisition cost but a reduced need for magnesium replacement .
RESULTS	During the first 24 hours of hospitalization , 4 of 24 patients ( 17 % ) treated with 0.9 % sodium chloride injection and none of the patients who received the comparator product ( n = 22 ) required supplemental magnesium .
RESULTS	Patients treated with 0.9 % sodium chloride injection received a median of 4 g of magnesium ( interquartile range [ IQR ] , 2.5-4 .0 g ) , compared with a median of 0 g ( IQR 0-2 g ) in the comparator group .
RESULTS	Taking into account the costs of consumable supplies and nursing labor , the cost-minimization analysis indicated a 24-hour cost differential of $ 12.35 in favor of Plasma-Lyte A.
CONCLUSIONS	Substitution of Plasma-Lyte A for 0.9 % sodium chloride injection for fluid resuscitation during the first 24 hours after traumatic injury was associated with decreased magnesium replacement requirements and a net cost benefit to the institution .

###24321275
BACKGROUND	Persons with low back pain fail to show the same transition as healthy individuals from in-phase to anti-phase rotation of the thorax and pelvis as walking speed increases .
BACKGROUND	The purpose of this study was to determine if the relative phase of the thorax and pelvis during walking was a reliable ( within day test-retest ) and valid measure for persons with thoracic pain .
METHODS	The time series motion of the spine over C7 , T8 and sacrum were measured at five treadmill walking speeds ( 0.67 , 0.89 , 1.12 , 1.34 , 1.56 m/s ) in 19 persons with thoracic spine pain and 19 healthy control subjects .
METHODS	After a 20minute rest , all tests were repeated .
METHODS	The average relative phases of the transverse plane rotation between C7-T8 , C7-sacrum and T8-sacrum during a one-minute walk were calculated .
METHODS	The standard error of measurement ( SEM ) and the intra-class correlation coefficient ( ICC ) were used to estimate test-retest reliability .
METHODS	Three-way repeated measures analyses of variance were performed to determine the influence of group , walking speed and session on the relative phases .
RESULTS	The minimum transverse plane motion amplitudes , across all participants and speeds , for the C7-T8 , C7-sacrum , and T8-sacrum were 2.9 , 5.1 and 2.8 degrees , respectively .
RESULTS	The C7-T8 relative phase changed little with speed .
RESULTS	The C7-sacrum and T8-sacrum relative phases showed increases as subjects walked faster , but both groups had similar patterns of change .
RESULTS	Only the C7-T8 relative phase at 0.67 and 0.89 m/s exhibited good reliability ( ICC > 0.80 , SEM 4.2-5 .7 , no significant time effects ) for both groups .
RESULTS	The C7-T8 and T8-sacrum relative phases demonstrated significant group by speed effects .
CONCLUSIONS	The C7-T8 relative phase showed reasonable reliability and some discrimination between groups , but changes in response to walking speed were small .
CONCLUSIONS	The T8-sacrum relative phase showed some discriminative ability , but reliability was not adequate .

###25539714
BACKGROUND	Urinary incontinence ( UI ) affects half of patients hospitalised after stroke and is often poorly managed .
BACKGROUND	Cochrane systematic reviews have shown some positive impact of conservative interventions ( such as bladder training ) in reducing UI , but their effectiveness has not been demonstrated with stroke patients .
METHODS	We conducted a cluster randomised controlled feasibility trial of a systematic voiding programme ( SVP ) for the management of UI after stroke .
METHODS	Stroke services were randomised to receive SVP ( n = 4 ) , SVP plus supported implementation ( SVP + , n = 4 ) , or usual care ( UC , n = 4 ) .
METHODS	Feasibility outcomes were participant recruitment and retention .
METHODS	The main effectiveness outcome was presence or absence of UI at six and 12 weeks post-stroke .
METHODS	Additional effectiveness outcomes included were the effect of the intervention on different types of UI , continence status at discharge , UI severity , functional ability , quality of life , and death .
RESULTS	It was possible to recruit patients ( 413 ; 164 SVP , 125 SVP + , and 124 UC ) and participant retention was acceptable ( 85 % and 88 % at six and 12 weeks , respectively ) .
RESULTS	There was no suggestion of a beneficial effect on the main outcome at six ( SVP versus UC : odds ratio ( OR ) 0.94 , 95 % CI : 0.46 to 1.94 ; SVP + versus UC : OR : 0.62 , 95 % CI : 0.28 to 1.37 ) or 12 weeks ( SVP versus UC : OR : 1.02 , 95 % CI : 0.54 to 1.93 ; SVP + versus UC : OR : 1.06 , 95 % CI : 0.54 to 2.09 ) .
RESULTS	No secondary outcomes showed a strong suggestion of clinically meaningful improvement in SVP and/or SVP + arms relative to UC at six or 12 weeks .
RESULTS	However , at 12 weeks both intervention arms had higher estimated odds of continence than UC for patients with urge incontinence .
CONCLUSIONS	The trial has met feasibility outcomes of participant recruitment and retention .
CONCLUSIONS	It was not powered to demonstrate effectiveness , but there is some evidence of a potential reduction in the odds of specific types of incontinence .
CONCLUSIONS	A full trial should now be considered .
BACKGROUND	ISRCTN Registry , ISRCTN08609907 , date of registration : 7 July 2010 .

###24529292
BACKGROUND	The solubility of valsartan is dependent on pH and thus may cause patient variability in drug absorption and failure in bioequivalence studies ; thus , increasing the solubility and release of valsartan at low pH has been suggested for a more favorable pharmacokinetic profile .
BACKGROUND	However , due to this pH dependence , the change in the formulation process could alter the disintegration and/or dissolution profile of the drug , possibly making the results of bioequivalence studies misleading .
OBJECTIVE	The aim of this study was to assess the bioavailability and tolerability of a newly developed oral formulation of valsartan 160 mg ( wet-granulation tablet ) in healthy Korean male volunteers .
METHODS	This study was performed with the subjects under fasted conditions , using a randomized , single-dose , 2-period crossover design .
METHODS	Subjects were assigned to receive , in randomized order , a single dose of the test formulation and a reference formulation ( valsartan 160-mg dry-granulation tablet ) , with a washout period of 7 days between the administrations .
METHODS	Blood samples were collected up to 24 hours after dosing , and pharmacokinetic parameters were determined after the plasma valsartan concentration was analyzed using UPLC-MS/MS .
METHODS	The dissolution studies of both formulations were conducted using USP apparatus 2 at 50 rpm with 1000 mL of phosphate buffer solution ( pH , 6.8 ) at 37C 0.5 C. Bioequivalence was defined per Korean Food and Drug Administration 's regulatory criteria as 90 % CIs of the geometric mean test/reference ratios of AUC0-t and Cmax within the range of 0.8 to 1.25 .
METHODS	Tolerability was assessed using physical examination and subject interviews .
RESULTS	Sixty subjects were enrolled ( mean [ SD ] age [ range ] , 23.6 [ 2.4 ] years [ 21-31 ] ; height , 173.7 [ 6.6 ] cm [ 161-190 ] ; and weight , 68.0 [ 8.7 ] kg [ 54-85 ] ) .
RESULTS	The mean AUC0 - values with the test and reference tablets were 31,784 ( 13,844 ) and 32,714 ( 14,512 ) ng h/mL , respectively ; Cmax , 5094 ( 2061 ) and 5064 ( 1864 ) ng/mL ; Tmax , 2.92 ( 1.04 ) and 3.08 ( 1.01 ) hours .
RESULTS	The 90 % CIs for the geometric mean test/reference ratios of AUC0-t and Cmax were 0.9295 to 1.0546 and 0.9190 to 1.0848 , respectively , which met the criteria for bioequivalence .
RESULTS	The most frequently reported adverse event was dizziness after blank blood sampling , recorded in 4 subjects , 2 cases each with the test and reference formulations .
CONCLUSIONS	In this study in healthy Korean male volunteers , the test and reference formulations of 160-mg valsartan met the Korean Food and Drug Administration 's regulatory criteria for bioequivalence despite the difference in formulation ( wet granulation vs dry granulation ) .
CONCLUSIONS	Both formulations were well tolerated , with no serious adverse events reported .

###25222307
BACKGROUND	As the influenza A H1N1 pandemic emerged in 2009 , children were found to experience high morbidity and mortality and were prioritized for vaccination .
BACKGROUND	This multicenter , randomized , double-blind , age-stratified trial assessed the safety and immunogenicity of inactivated influenza A ( H1N1 ) pdm09 vaccine in healthy children aged 6 months to 17 years .
METHODS	Children received 2 doses of approximately 15 or 30 g hemagglutin antigen 21 days apart .
METHODS	Reactogenicity was assessed for 8 days after each dose , adverse events through day 42 , and serious adverse events or new-onset chronic illnesses through day 201 .
METHODS	Serum hemagglutination inhibition titers were measured on days 0 ( prevaccination ) , 8 , 21 , 29 and 42 .
RESULTS	A total of 583 children received the first dose and 571 received the second dose of vaccine .
RESULTS	Vaccinations were generally well-tolerated and no related serious adverse events were observed .
RESULTS	The 15 g dosage elicited a seroprotective hemagglutination inhibition ( 1:40 ) in 20 % , 47 % and 93 % of children in the 6-35 month , 3-9 year and 10-17 year age strata 21 days after dose 1 and in 78 % , 82 % and 98 % of children 21 days after dose 2 , respectively .
RESULTS	The 30 g vaccine dosage induced similar responses .
CONCLUSIONS	The inactivated influenza A ( H1N1 ) pdm09 vaccine exhibited a favorable safety profile at both dosage levels .
CONCLUSIONS	While a single 15 or 30 g dose induced seroprotective antibody responses in most children 10-17 years of age , younger children required 2 doses , even when receiving dosages 4 - to 6-fold higher than recommended .
CONCLUSIONS	Well-tolerated vaccines are needed that induce immunity after a single dose for use in young children during influenza pandemics .

###24946630
OBJECTIVE	To observe the difference in clinical efficacy on focal vitiligo treated with heat-sensitive moxibustion in comparison with medication , and discuss its effect mechanism .
METHODS	Sixty-eight cases were randomized into a moxibustion group ( 38 cases ) and a medication group ( 30 cases ) .
METHODS	Additionally , 20 healthy persons were selected randomly as a normal group .
METHODS	In the moxibustion group , the heat-sensitive moxibustion was applied to Hegu ( LI 4 ) , Quchi ( LI 11 ) , Yanglingquan ( GB 34 ) , Zusanli ( ST 36 ) , Xuehai ( SP 10 ) and the others , once a day .
METHODS	In the medication group , triamcinolone acetonide cream was used externally and locally , twice a day .
METHODS	In the two groups , the treatment of 15 days made one session .
METHODS	The efficacy was observed after continuous treatment for 3 sessions .
METHODS	The hemorheology test was done in all of the subjects .
METHODS	The radioimmunoassay was adopted to determine the levels of Interleukin 2 ( IL-2 ) , Interleukin 6 ( IL-6 ) , Interleukin 10 ( IL-10 ) and tumor necrosis factor ( TNF-alpha ) before and after treatment .
RESULTS	The levels of IL-6 , IL-10 and TNF-alpha in vitiligo patients were higher significantly than those in the normal group ( P < 0.01 , P < 0.05 ) , the level of IL-2 was lower significantly than that in the normal group ( P < 0.01 ) before treatment .
RESULTS	After 3 sessions treatment , IL-2 level was increased significantly in the moxibustion group and the levels of IL-6 , IL-10 and TNF-alpha were reduced , without significant differences as compared with the normal group ( all P > 0.05 ) .
RESULTS	But the differences were significant as compared with those in the medication group ( all P < 0.05 ) .
RESULTS	The curative and remarkably effective rate was 76.3 % ( 29/38 ) after treatment in the moxibustion group , which was higher significantly than 13.3 % ( 4/30 , P < 0.05 ) in the medication group .
CONCLUSIONS	Heat-sensitive moxibustion achieves very good clinical efficacy on focal vitiligo , which is probably via promoting blood circulation and regulating the levels of IL-6 , IL-10 and TNF-alpha .

###24439983
BACKGROUND	Epoprostenol sodium with arginine-mannitol excipients ( epoprostenol AM ; Veletri [ Actelion Pharmaceuticals Ltd , Allschwil , Switzerland ] ) and epoprostenol sodium with glycine-mannitol excipients ( epoprostenol GM ; Flolan [ GlaxoSmithKline , Triangle Park , NC ] ) are intravenous treatments for pulmonary arterial hypertension ( PAH ) .
BACKGROUND	Epoprostenol AM contains different inactive excipients , resulting in greater stability at room temperature compared with epoprostenol GM .
METHODS	In this prospective , multicenter , open-label , randomized , phase IV exploratory study , epoprostenol-nave patients in need of injectable prostanoid therapy were randomized 2:1 to open-label epoprostenol AM or epoprostenol GM .
METHODS	The study period was 28 days , followed by a 30-day safety follow-up .
METHODS	Study aims were to descriptively compare the safety , tolerability , drug metabolite levels , and treatment effects of epoprostenol AM and epoprostenol GM in PAH .
METHODS	Statistical analysis was descriptive only because of the exploratory nature of the study .
RESULTS	Thirty patients with PAH ( 18-70 years , 24 women , 20 idiopathic PAH ) were randomized to epoprostenol AM ( n = 20 ) or epoprostenol GM ( n = 10 ) .
RESULTS	Most frequently reported adverse events included jaw pain , headache , nausea , and flushing .
RESULTS	Two deaths occurred during the study period , and 1 death occurred during the 30-day safety follow-up period , all in patients receiving epoprostenol AM .
RESULTS	All deaths were classified by the treating physician as unrelated to epoprostenol AM .
RESULTS	The median ( range ) change from baseline to day 28 in 6-minute walk distance was 36 m ( -127 to 210 m ) and 49 m ( -44 to 110 m ) for the epoprostenol AM and epoprostenol GM groups , respectively .
CONCLUSIONS	In this randomized clinical study of epoprostenol AM in PAH , use of this novel preparation with greater room temperature stability was well tolerated .

###25462646
OBJECTIVE	Internet addiction is one of the most common problems among adolescents and effective treatment is needed .
OBJECTIVE	This research aims to test the effectiveness and underlying mechanism of multi-family group therapy ( MFGT ) to reduce Internet addiction among adolescents .
METHODS	A total of 92 participants consisting of 46 adolescents with Internet addiction , aged 12-18years , and 46 their parents , aged 35-46years , were assigned to the experimental group ( six-session MFGT intervention ) or a waiting-list control .
METHODS	Structured questionnaires were administered at pre-intervention ( T1 ) , post-intervention ( T2 ) and a three-month follow-up ( T3 ) .
RESULTS	There was a significant difference in the decline both in the average score and proportion of adolescents with Internet addiction in MFGT group at post-intervention ( MT1 = 3.40 , MT2 = 2.46 , p < 0.001 ; 100 versus 4.8 % , p < 0.001 ) maintained for three months ( MT3 = 2.06 , p < 0.001 ; 100 versus 11.1 % , p < 0.001 ) .
RESULTS	Reports from both adolescents and parents were significantly better than those in the control group .
RESULTS	Further explorations of the underlying mechanisms of effectiveness based on the changed values of measured variables showed that the improvement in adolescent Internet use was partially explained by the satisfaction of their psychological needs and improved parent-adolescent communication and closeness .
CONCLUSIONS	The six-session multi-family group therapy was effective in reducing Internet addiction behaviors among adolescents and could be implemented as part of routine primary care clinic services in similar populations .
CONCLUSIONS	As family support system is critical in maintaining the intervention effect , fostering positive parent-adolescent interaction and addressing adolescents ' psychological needs should be included in preventive programs for Internet addiction in the future .

###24800921
OBJECTIVE	To investigate the potential effect of sugammadex on anti-Xa anticoagulantactivity of enoxaparin and the activated partial thromboplastin time ( APTT ) of unfractionated heparin ( UFH ) .
METHODS	This two-part , randomized , double-blind , placebocontrolled , four-period cross-over study was performed in healthy males ( 18 - 45 years ) .
METHODS	In each period , subjects received 40 mg enoxaparin ( in part 1 ) , 5,000 units UFH ( in part 2 ) , or placebo followed by 4 or 16 mg/kg sugammadex , or placebo .
METHODS	Treatments were separated by 4 days .
METHODS	Primary endpoints were anti-Xa activity and APTT both time-averaged from 3 to 30 minutes post-dose .
METHODS	Geometric mean ratios ( GMRs ) and their two-sided 90 % confidence limits were calculated for anticoagulant plus sugammadex ( 4 or 16 mg/kg ) vs. anticoagulant plus placebo .
METHODS	The pre-specified threshold for a potential effect of clinical relevance was a 90 % upper confidence limit ( UCL ) > 1.50 .
RESULTS	In part 1 ( n = 13 ) , the 90 % UCLs were 1.07 and 1.08 for GMRs of anti-Xa activity after dosing with 4 and 16 mg/kg sugammadex , respectively .
RESULTS	In part 2 ( n = 43 ) , the 90 % UCLs for GMRs of APTT were 1.06 and 1.15 .
RESULTS	Neither sugammadex dose produced a treatment effect that met the pre-specified criterion for potential clinical relevance .
RESULTS	Treatments were generally well tolerated .
CONCLUSIONS	In healthy subjects , treatment with 4 mg/kg and 16 mg/kg sugammadex did not change either anti-Xa activity or APTT to a clinically meaningful extent following pretreatments with enoxaparin or UFH .

###25171390
BACKGROUND	Hypertension is associated with cognitive deficits , particularly executive function , and decreased cerebral microvascular responsiveness to CO2 ( CO2 vasoreactivity ) .
BACKGROUND	The relation between CO2 vasoreactivity and executive function is not known .
BACKGROUND	Protocols to assess CO2 vasoreactivity are cumbersome and require inhaling a CO2-enriched gas .
BACKGROUND	We explored the ability to measure CO2 vasoreactivity using end-tidal CO2 fluctuations during normal breathing and the association of this measure with cognitive function in hypertension .
METHODS	Executive function ( Trail-Making Test parts A/B ) , memory , attention and blood flow velocity ( BFV ) in the middle cerebral artery using transcranial Doppler were measured in hypertensive subjects who were tapered off their treatment for 3 weeks .
METHODS	BFV was measured while sitting and normally breathing for 5 min , followed by breathing 5 % CO2 gas and hyperventilation for 2 min each .
METHODS	We calculated CO2 vasoreactivity as the rate of BFV change from hypoventilation to hyperventilation , and as a model-derived measure using the normal breathing data .
METHODS	The latter was derived using nonlinear principal dynamic modes ( PDM ) , which modelled the dynamic effect of fluctuations in end-tidal CO2 and blood pressure upon BFV during normal room-air respiration .
METHODS	Multiple regression analyses were used to correlate cerebral hemodynamics with cognitive measures .
RESULTS	Data were collected from 41 individuals with hypertension ( mean age 71 years , 24 % African Americans , 61 % women , off antihypertensive therapy ) .
RESULTS	Lower CO2 vasoreactivity was associated with a worse executive function test score using both calculation methods : p value using the hyper/hypoventilation data was 0.04 and from the PDM analysis was 0.009 .
RESULTS	PDM calculations showed a stronger correlation with executive function ( 0.41 vs. 0.21 using the hyper/hypoventilation data ) .
RESULTS	There were no associations with memory or attention measures .
RESULTS	There was a weak but statistically significant correlation between the two calculation methods of CO2 vasoreactivity ( R ( 2 ) = 14 % , p = 0.02 ) .
CONCLUSIONS	This study suggests that the decrease in CO2 vasoreactivity in hypertension is associated with lower executive function .
CONCLUSIONS	This may offer new insight into the vascular underpinning of cognitive decline in hypertension .
CONCLUSIONS	We demonstrate that calculating CO2 vasoreactivity is possible during normal breathing .
CONCLUSIONS	If replicated in future studies , this may offer a more convenient clinical way to assess CO2 vasoreactivity in hypertension and cognitive disorders .

###24534207
BACKGROUND	Obsessive-compulsive disorder ( OCD ) is a highly prevalent and devastating psychiatric condition .
BACKGROUND	Repetitive transcranial magnetic stimulation ( rTMS ) is a potential and non-invasive treatment for OCD .
BACKGROUND	Diverse efficacies of rTMS have been reported in different locations or frequencies of the stimulation .
BACKGROUND	The main objective of this study was to assess the treatment effect for OCD with alpha electroencephalogram ( EEG ) - guided TMS over dorsal lateral prefrontal cortex bilaterally .
METHODS	There were 25 OCD patients in the TMS treatment group and 21 OCD patients in the sham control group .
METHODS	Each subject received 10 daily treatment sessions ( 5 days a week ) .
METHODS	The TMS group had significant reduction in scores of Yale-Brown Obsessive Compulsive Scale and Hamilton Rating Scale for Anxiety ( HAMA ) compared with the control group at the end of 2-week treatment and 1-week follow-up .
METHODS	Analysis of variance with repeated measures was used to test the effects between the two groups .
RESULTS	Significant difference in scores of obsession and HAMA were found between the two groups after treatment .
RESULTS	No significant difference in scores of Hamilton Rating Scale for Depression was found between the two groups after the treatment , but statistical significance was shown at the end of 1-week follow-up .
CONCLUSIONS	EEG-guided TMS may be an effective treatment for OCD and related anxiety .
CONCLUSIONS	Delayed response to TMS in depression suggests that it might be secondary to the improvement of primary response in OCD and anxiety .

###24641678
BACKGROUND	Dopamine is an intermediate product in the biosynthesis of melanin pigment , which is absent or reduced in albinism .
BACKGROUND	Animal research has shown that supplying a precursor to dopamine , levodopa , may improve visual acuity in albinism by enhancing neural networks .
BACKGROUND	This study examines the safety and effectiveness of levodopa on best-corrected visual acuity in human subjects with albinism .
METHODS	Prospective , randomized , placebo-controlled , double-masked clinical trial conducted at the University of Minnesota .
METHODS	Forty-five subjects with albinism .
METHODS	Subjects with albinism were randomly assigned to one of three treatment arms : levodopa 0.76 mg/kg with 25 % carbidopa , levodopa 0.51 mg/kg with 25 % carbidopa , or placebo and followed for 20 weeks , with best-corrected visual acuity measured at enrollment , and at weeks 5 , 10 , 15 , and 20 after enrollment .
METHODS	Side-effects were recorded with a symptom survey .
METHODS	Blood was drawn for genotyping .
METHODS	Side-effects and best-corrected visual acuity 20 weeks after enrolment .
RESULTS	All subjects had at least one mutation found in a gene known to cause albinism .
RESULTS	Mean age was 14.5 years ( range : 3.5 to 57.8 years ) .
RESULTS	Follow up was 100 % and compliance was good .
RESULTS	Minor side-effects were reported ; there were no serious adverse events .
RESULTS	There was no statistically significant improvement in best-corrected visual acuity after 20 weeks with either dose of levodopa .
CONCLUSIONS	Levodopa , in the doses used in this trial and for the time course of administration , did not improve visual acuity in subjects with albinism .

###24467765
OBJECTIVE	To compare tensile strength , failure location , and histologic features after acute repeat celiotomy through a ventral median ( RVM ) or a right ventral paramedian ( RVP ) celiotomy in horses .
METHODS	Ex vivo experimental study .
METHODS	Adult horses ( N = 18 ) .
METHODS	Twelve adult horses had original ventral median ( OVM ) celiotomy .
METHODS	Repeat celiotomy was performed 72hours postoperatively through the original ventral median ( RVM , N = 6 ) or a RVP ( N = 6 ) celiotomy .
METHODS	Celiotomies were scored daily for edema , drainage , and dehiscence .
METHODS	Fourteen days after repeat celiotomy , horses were euthanatized and abdominal wall containing celiotomy ( ies ) were collected for biomechanical and histological evaluation .
METHODS	The abdominal wall of control horses ( N = 6 ; no celiotomy ) was collected for biomechanical testing .
METHODS	Vital sign variables , incisional edema , and histologic scores were compared using a Wilcoxon signed-rank test .
METHODS	Incisional fibrotic depth and tensile strength per unit length ( N/cm ) was compared using repeated measures ANOVA .
RESULTS	RVM and RVP horses had significantly less tensile strength compared to control horses , but no differences were observed between RVM and RVP horses .
RESULTS	No differences in healing , inflammation , infection , or necrosis of repeat celiotomies was observed , but RVP horses accumulated more fibrin and hemorrhage within the incision .
RESULTS	RVP horses had significantly greater incisional edema scores , but incisional drainage was more frequent in RVM horses .
CONCLUSIONS	Acute repeat celiotomy through a RVM incision results in similar incisional healing and tensile strength compared with repeat celiotomy through a RVP incision .

###25986018
OBJECTIVE	To test the hypothesis that supplementation with the long chain polyunsaturated fatty acids docosahexaenoic acid ( DHA ) and arachidonic acid ( AA ) to very low birth weight ( VLBW ) infants would improve long-term cognitive functions and influence neuroanatomical volumes and cerebral cortex measured by MRI .
METHODS	The current study is a follow-up of a randomized , double-blinded , placebo-controlled study of supplementation with high-dose DHA ( 0.86 % ) and AA ( 0.91 % ) to 129 VLBW infants fed human milk .
METHODS	Ninety-eight children participated at 8 years follow-up and completed a broad battery of cognitive tests .
METHODS	Eighty-one children had cerebral MRI scans of acceptable quality .
RESULTS	There were no significant differences between the intervention group and the control group on any of the cognitive measures .
RESULTS	Equally , MRI data on segmental brain volumes and cerebral cortex volume , area , and thickness suggested no overall group effect .
CONCLUSIONS	This study is the first long-term follow-up of a randomized controlled trial with supplementation of DHA and AA to human milk fed VLBW infants investigating both cognitive functions and brain macrostructure measured by MRI .
CONCLUSIONS	No cognitive or neuroanatomical effects of the supplementation were detected at 8 years of age .

###26387392
BACKGROUND	Water extract from Malvastrum coromandelianum ( Linn . )
BACKGROUND	Garcke ( MC ) has been shown to have glucose lowering effect , short - and long-term safety in animal studies .
BACKGROUND	A preliminary study in human reveals safety and its potential use as an adjunctive treatment to antihyperglycemic medications .
OBJECTIVE	To investigate the glycemic-lowering efficacy ofMC in type 2 diabetes subjects .
METHODS	A multicenter randomized , double-blind , placebo-controlled trial was conducted .
METHODS	Seventy-one diabetes subjects , who were treated with either diet control or single oral anti-diabetic drug ( sulphonylurea or biguanide ) with HbA1C between 6.5-9 % , were recruited .
METHODS	Subjects were randomized to take MC tablets in a total dose of 1,200 mg/day or placebo for 12 weeks .
METHODS	Clinical parameters , glycemic control , HOMA-IR and HOMA - were assessed .
RESULTS	Both MC ( n = 34 ) and placebo ( n = 37 ) groups had comparable baseline characteristics with a mean baseline HbA1C of 7.6 0.82 vs. 7.5 0.8 % , respectively .
RESULTS	During the study , HbA1C did not differ statistically after 4 , 8 and 12 weeks of treatment ( 7.7 0.97 vs. 7.6 1.0 , 7.9 1.09 vs. 7.8 1.03 and 7.8 1.1 vs. 7.6 1.1 % , respectively ) .
RESULTS	The body weight , insulin resistance and insulin secretion were also similar between groups ( p > 0.05 ) .
RESULTS	No episode of hypoglycemia was reported .
CONCLUSIONS	MC in a dosage of 1,200 mg/day does not have glucose lowering efficacy in type 2 diabetes .

###24597931
BACKGROUND	This randomized Phase III trial will evaluate whether the methylene blue-assisted technique is efficient for harvesting lymph nodes after radical surgery for gastric cancer .
METHODS	Patients that undergo distal or total gastrectomy with radical nodal dissection will be randomly assigned to Group A : the standard group , the lymph nodes ( LNs ) will be harvested from the fresh specimen immediately after surgery , or Group B : the methylene blue-assisted group , where the LNs will be harvested from specimens fixed with 10 % buffered formalin with methylene blue for 48 hours after surgery .
METHODS	The primary endpoint is the ratio of the number of the harvested LNs per time ( minute ) .
METHODS	The secondary endpoint is the number of harvested LNs .
METHODS	A 25 % reduction in the ratio of harvested lymph-node/time ( minute ) was determined to be necessary for this test treatment , considering the balance between the cost and benefit .
METHODS	Retrospective data was used to estimate the ratio of the number of the harvested LNs per time ( minute ) to be 40/30 minutes in Group A.
METHODS	A 25 % risk reduction and a rate of 40/22 .5 minutes is expected in Group B. Therefore , the sample size required ensuring a two-sided alpha error of 5 % and statistical power of 80 % is 52 patients , with 26 patients per arm .
METHODS	The number of patients to be accrued was set at 60 in total , due to the likelihood of enrolling ineligible patients .
BACKGROUND	UMIN000008624 .

###26441181
OBJECTIVE	Perforated colonic diverticulitis usually requires surgical resection , which is associated with significant morbidity .
OBJECTIVE	Cohort studies have suggested that laparoscopic lavage may treat perforated diverticulitis with less morbidity than resection procedures .
OBJECTIVE	To compare the outcomes from laparoscopic lavage with those for colon resection for perforated diverticulitis .
METHODS	Multicenter , randomized clinical superiority trial recruiting participants from 21 centers in Sweden and Norway from February 2010 to June 2014 .
METHODS	The last patient follow-up was in December 2014 and final review and verification of the medical records was assessed in March 2015 .
METHODS	Patients with suspected perforated diverticulitis , a clinical indication for emergency surgery , and free air on an abdominal computed tomography scan were eligible .
METHODS	Of 509 patients screened , 415 were eligible and 199 were enrolled .
METHODS	Patients were assigned to undergo laparoscopic peritoneal lavage ( n = 101 ) or colon resection ( n = 98 ) based on a computer-generated , center-stratified block randomization .
METHODS	All patients with fecal peritonitis ( 15 patients in the laparoscopic peritoneal lavage group vs 13 in the colon resection group ) underwent colon resection .
METHODS	Patients with a pathology requiring treatment beyond that necessary for perforated diverticulitis ( 12 in the laparoscopic lavage group vs 13 in the colon resection group ) were also excluded from the protocol operations and treated as required for the pathology encountered .
METHODS	The primary outcome was severe postoperative complications ( Clavien-Dindo score > IIIa ) within 90 days .
METHODS	Secondary outcomes included other postoperative complications , reoperations , length of operating time , length of postoperative hospital stay , and quality of life .
RESULTS	The primary outcome was observed in 31 of 101 patients ( 30.7 % ) in the laparoscopic lavage group and 25 of 96 patients ( 26.0 % ) in the colon resection group ( difference , 4.7 % [ 95 % CI , -7.9 % to 17.0 % ] ; P = .53 ) .
RESULTS	Mortality at 90 days did not significantly differ between the laparoscopic lavage group ( 14 patients [ 13.9 % ] ) and the colon resection group ( 11 patients [ 11.5 % ] ; difference , 2.4 % [ 95 % CI , -7.2 % to 11.9 % ] ; P = .67 ) .
RESULTS	The reoperation rate was significantly higher in the laparoscopic lavage group ( 15 of 74 patients [ 20.3 % ] ) than in the colon resection group ( 4 of 70 patients [ 5.7 % ] ; difference , 14.6 % [ 95 % CI , 3.5 % to 25.6 % ] ; P = .01 ) for patients who did not have fecal peritonitis .
RESULTS	The length of operating time was significantly shorter in the laparoscopic lavage group ; whereas , length of postoperative hospital stay and quality of life did not differ significantly between groups .
RESULTS	Four sigmoid carcinomas were missed with laparoscopic lavage .
CONCLUSIONS	Among patients with likely perforated diverticulitis and undergoing emergency surgery , the use of laparoscopic lavage vs primary resection did not reduce severe postoperative complications and led to worse outcomes in secondary end points .
CONCLUSIONS	These findings do not support laparoscopic lavage for treatment of perforated diverticulitis .
BACKGROUND	clinicaltrials.gov Identifier : NCT01047462 .

###25310464
OBJECTIVE	We conducted a randomized trial among overweight long-distance drivers to study the effects of structured lifestyle counseling on body weight and cardiometabolic risk factors .
METHODS	Men with waist circumference > 100 cm were randomized into a lifestyle counseling ( LIFE , N = 55 ) and a reference ( REF , N = 58 ) group .
METHODS	The LIFE group participated in monthly counseling on nutrition , physical activity , and sleep for 12 months aiming at 10 % weight loss .
METHODS	After 12 months , the REF group participated in 3-month counseling .
METHODS	Assessments took place at 0 , 12 , and 24 months .
METHODS	Between-group differences in changes were analyzed by generalized linear modeling .
METHODS	Metabolic risk ( Z score ) was calculated from components of metabolic syndrome .
RESULTS	The mean body weight change after 12 months was -3.4 kg in LIFE ( N = 47 ) and 0.7 kg in REF ( N = 48 ) [ net difference -4.0 kg , 95 % confidence interval ( 95 % CI ) -1.9 - -6.2 ] .
RESULTS	Six men in LIFE reduced body weight by 10 % .
RESULTS	Changes in waist circumference were -4.7 cm in LIFE and -0.1 cm in REF ( net -4.7 cm , 95 % CI -6.6 - -2.7 ) .
RESULTS	Metabolic risk decreased more in the LIFE than REF group ( net -1.2 points , 95 % CI -0.6 - -2.0 ) .
RESULTS	After 24 months follow-up , there were no between-group differences in changes in body weight ( net -0.5 kg , 95 % CI -3.8 -2.9 ) or metabolic risk score ( net 0.1 points ; 95 % CI -0.8 -1.0 ) compared to baseline .
CONCLUSIONS	Weight reduction and decreases in cardiometabolic risk factors were clinically meaningful after 12 months of counseling .

###24319955
OBJECTIVE	To observe the therapeutic effects of Pegasys ( pegylated interferon alpha-2a ) in chronic hepatitis B ( CHB ) patients with low-level alanine transaminase ( ALT ) < 2 x upper limit of normal ( ULN ) .
METHODS	One hundred and seven CHB patients were randomized enrolled including 52 with ALT < 2 x ULN and liver tissues inflammation activity > or = G2 as observational group and 55 with ALT > 2 x ULN as control group .
METHODS	All the enrolled patients received pegasys treatment for 48 weeks and the responses between two groups were compared .
METHODS	Measurement data were analyzed using t test and numeration data were analyzed using chi square test .
RESULTS	The reductions of HBV DNA in observational group at different time points were all less than control group ( all P < 0.05 ) .
RESULTS	At the end of treatment , the HBV DNA negative rate , HBeAg seroconversion rate and HBsAg loss rate in the observational group were 51.9 % , 48.8 % and 1.9 % , respectively , which were all lower than control group ( 67.3 % , 66.7 % and 7.3 % , respectivley ) ( all P < 0.05 ) .
RESULTS	The ALT normalization rates of two groups were 75 % and 76.4 % ( P > 0.05 ) .
CONCLUSIONS	Pegasys is efficient for CHB patients with ALT < 2 x ULN and liver tissues inflammation activity > or = G2 , while it is still inferior to those with ALT > 2 x ULN .

###25266443
BACKGROUND	Adverse events associated with 5-fluorouracil ( 5FU ) based adjuvant therapy in colorectal cancer ( CRC ) patients may predict survival .
BACKGROUND	We studied whether haematological ( leucopenia , neutropenia , thrombocytopenia ) or non-haematological ( mucositis , diarrhoea , nausea/vomiting , hand-foot syndrome or other toxicity ) adverse events were associated with disease-free survival ( DFS ) or overall survival ( OS ) in a large patient material treated with 5-fluorouracil based adjuvant chemotherapy .
METHODS	Data from two prospective randomised adjuvant trials were combined to achieve a dataset of 1033 radically operated stage II and III CRC patients treated with either monthly 5FU and leucovorin ( LV ) as bolus injections ( Mayo or modified Mayo ) or bi-monthly with bolus and continuous infusion ( LV5FU2 or simplified LV5FU2 ) .
METHODS	Toxicities were recorded at each treatment cycle according to NCI-C CTC ( the Common Toxicity Criteria of the National Cancer Institute of Canada ) .
METHODS	The worst toxicity grade was taken into account .
METHODS	The median follow-up time of patients was 6.05 years .
RESULTS	47 % of patients developed neutropenia , 54 % nausea/vomiting and 43 % mucositis .
RESULTS	Any grade neutropenia was associated with improved DFS ( hazard ratio ( HR ) 0.81 ) , any grade nausea/vomiting with improved DFS ( HR 0.79 ) and OS ( HR 0.62 ) and mucositis with improved DFS ( HR 0.74 ) and OS ( HR 0.72 ) .
RESULTS	Patients experiencing no predefined toxicity had the worst outcome .
CONCLUSIONS	Specific adverse events related to adjuvant fluorouracil chemotherapy are associated with improved DFS and OS in early stage CRC patients .

###25377588
BACKGROUND	Intimate partner violence ( IPV ) violates women 's human rights , and it is a serious public health concern associated with increased HIV risk .
BACKGROUND	SASA !
BACKGROUND	, a phased community mobilization intervention , engages communities to prevent IPV and promote gender equity .
BACKGROUND	The SASA !
BACKGROUND	study assessed the community-level impact of SASA !
BACKGROUND	on reported HIV-related risk behaviours and relationship dynamics .
METHODS	Data were collected as part of a cluster randomized controlled trial conducted between 2007 and 2012 in eight communities in Kampala .
METHODS	An adjusted cluster-level intention to treat analysis , compares secondary outcomes in intervention and control communities at follow-up .
METHODS	The qualitative evaluation explored participants ' subjective experience of SASA !
METHODS	A total of 82 in-depth interviews were audio recorded at follow-up , transcribed verbatim and analyzed using thematic analysis .
RESULTS	Men in intervention communities were significantly more likely than controls to report a broad range of HIV-protective behaviours , including higher levels of condom use ( aRR 2.03 , 95 % CI 1.22-3 .39 ) , HIV testing ( aRR 1.50 , 95 % CI 1.13-2 .00 ) and fewer concurrent partners ( aRR 0.60 , 95 % CI 0.37-0 .97 ) .
RESULTS	They were also more likely to report increased joint decision-making ( aRR 1.92 , 95 % CI 1.27-2 .91 ) , greater male participation in household tasks ( aRR 1.48 , 95 % CI 1.09-2 .01 ) , more open communication and greater appreciation of their partner 's work inside ( aRR 1.31 , 95 % CI 1.04-1 .66 ) and outside ( aRR 1.49 , 95 % CI 1.08-2 .06 ) the home .
RESULTS	For women , all outcomes were in the hypothesized direction , but effect sizes were smaller .
RESULTS	Only some achieved statistical significance .
RESULTS	Women in intervention communities were significantly more likely to report being able to refuse sex with their partners ( aRR 1.16 , 95 % CI 1.00-1 .35 ) , joint decision-making ( aRR 1.37 , 95 % CI 1.06-1 .78 ) and more open communication on a number of indicators .
RESULTS	Qualitative interviews suggest that shifts operated through broader improvements in relationships , including increased trust and cooperation , participants ' greater awareness of the connections between HIV and IPV and their resultant desire to improve their relationships .
RESULTS	Barriers to change include partial uptake of SASA !
RESULTS	, partner resistance , fear and entrenched previous beliefs .
CONCLUSIONS	SASA !
CONCLUSIONS	impacted positively on reported HIV-related risk behaviours and relationship dynamics at a community level , especially among men .
CONCLUSIONS	Social change programmes focusing on IPV and gender equity could play an important role in HIV prevention efforts .

###25539586
BACKGROUND	Ceftriaxone with or without a macrolide antibiotic is a recommended treatment for patients with community-acquired pneumonia requiring hospital admission and intravenous antibiotic treatment .
BACKGROUND	We aimed to assess the efficacy and safety of ceftaroline fosamil compared with ceftriaxone in the treatment of Asian patients admitted to hospital with community-acquired pneumonia .
METHODS	In this international , randomised , controlled , double-blind , phase 3 , non-inferiority with nested superiority trial , adult Asian patients with Pneumonia Outcomes Research Team ( PORT ) risk class III-IV acute community-acquired pneumonia were randomly assigned ( 1:1 ) to receive intravenous ceftaroline fosamil ( 600 mg every 12 h ) or ceftriaxone ( 2 g every 24 h ) for 5-7 days .
METHODS	Patients were randomly assigned via centralised telephone and web-based system ; patients and treating clinicians were masked to treatment allocation .
METHODS	Investigators who did study assessments remained masked to treatment allocation until completion of the study .
METHODS	The primary endpoint was clinical cure at the test-of-cure visit ( 8-15 days after last dose of study drug ) in the clinically evaluable population .
METHODS	Non-inferiority of ceftaroline fosamil was defined as a lower limit of the two-sided 95 % CI for the difference in the proportion of patients clinically cured of -10 % or higher ; if non-inferiority was achieved , superiority was to be concluded if the lower limit of the 95 % CI was greater than 0 % .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01371838 .
RESULTS	Between Dec 13 , 2011 , and April 26 , 2013 , 847 patients were enrolled at 64 centres in China , India , South Korea , Taiwan , and Vietnam , of whom 771 were randomly assigned and 764 received study treatment .
RESULTS	In the clinically evaluable population ( n = 498 ) 217 ( 84 % ) of 258 patients in the ceftaroline fosamil group and 178 ( 74 % ) of 240 patients in the ceftriaxone group were clinically cured at the test-of-cure visit ( difference 99 % , 95 % CI 28-171 ) .
RESULTS	The superiority of ceftaroline fosamil was consistent across all preplanned patient subgroup analyses ( split by age 65 years , age 75 years , sex , PORT risk class , and previous antibiotic use ) apart from patients younger than 65 years .
RESULTS	The frequency of adverse events was similar between treatment groups and the safety results for ceftaroline fosamil were consistent with the cephalosporin class and previous clinical trial data .
CONCLUSIONS	Ceftaroline fosamil 600 mg given every 12 h was superior to ceftriaxone 2 g given every 24 h for the treatment of Asian patients with PORT III-IV community-acquired pneumonia .
CONCLUSIONS	These data suggest that ceftaroline fosamil should be regarded as an alternative to ceftriaxone in empirical treatment regimens for this patient population .
BACKGROUND	AstraZeneca .

###25711332
OBJECTIVE	HIV infection is associated with a higher prevalence of low bone mineral density ( BMD ) and fractures than that found in the general population .
OBJECTIVE	There are limited data in HIV-positive adults , nave to antiretroviral therapy ( ART ) , with which to estimate the relative contribution of untreated HIV infection to bone loss .
METHODS	The primary objective of the Strategic Timing of AntiRetroviral Treatment ( START ) Bone Mineral Density Substudy is to compare the effect of immediate versus deferred initial ART on bone .
METHODS	We evaluated traditional , demographic , HIV-related and immunological factors for their associations with baseline hip and lumbar spine BMD , measured by dual-energy X-ray absorptiometry , using multiple regression .
RESULTS	A total of 424 ART-nave participants were enrolled at 33 sites on six continents ; the mean age was 34 years [ standard deviation ( SD ) 10.1 years ] , 79.0 % were nonwhite , 26.0 % were women , and 12.5 % had a body mass index ( BMI ) < 20kg/m ( 2 ) .
RESULTS	Mean ( SD ) Z-scores were -0.41 ( 0.94 ) at the spine and -0.36 ( 0.88 ) for total hip ; 1.9 % had osteoporosis and 35.1 % had low BMD ( hip or spine T-score < -1.0 ) .
RESULTS	Factors independently associated with lower BMD at the hip and spine were female sex , Latino/Hispanic ethnicity , lower BMI and higher estimated glomerular filtration rate .
RESULTS	Longer time since HIV diagnosis was associated with lower hip BMD .
RESULTS	Current or nadir CD4 cell count and HIV viral load were not associated with BMD .
CONCLUSIONS	In this geographically and racially diverse population of ART-nave adults with normal CD4 cell counts , low BMD was common , but osteoporosis was rare .
CONCLUSIONS	Lower BMD was significantly associated with traditional risk factors but not with CD4 cell count or viral load .

###25306809
OBJECTIVE	To compare the effectiveness and safety of transurethral resection of the prostate ( TURP ) and transurethral enucleative resection of the prostate ( TUERP ) in the treatment of benign prostate hyperplasia ( BPH ) .
METHODS	A total of 630 BPH patients with indication of surgery were randomly assigned to receive TURP ( n = 305 ) and TUERP ( n = 325 ) , respectively .
METHODS	There were no significant differences preoperatively in age , prostate volume , International Prostate Symptom Score ( IPSS ) , and Qmax between the two groups ( P > 0.05 ) .
METHODS	The prostate resection rate , operation time , postoperative complications , and quality of life ( QOL ) of the patients were recorded and statistically analyzed .
RESULTS	Compared with TURP , TUERP showed a significantly higher rate of prostate resection ( [ 47.0 + / - 13.3 ] vs [ 60.1 + / - 12.3 ] % , P < 0.05 ) , shorter operation time ( [ 57.9 + / - 15.9 ] vs [ 40.4 + / - 14.2 ] min , P < 0.05 ) , and shorter bladder irrigation time ( [ 2.7 + / - 0.6 ] vs [ 2.2 + 1.1 ] d , P < 0.05 ) .
RESULTS	Significant differences were found between the pre - and post-operative levels of serum sodium and hemoglobin in the TURP group ( [ 141.2 + / - 3.5 ] vs [ 136.9 + / - 4.7 ] mmol/L , P < 0.01 ; [ 137.6 + / - 8.8 ] vs [ 124.8 + / - 9.6 ] g/L , P < 0.01 ) , but not in the TUERP group .
RESULTS	Three months after operation , IPSS , QOL , and Qmax were all markedly improved in both groups ( P < 0.01 ) , but with no significant differences between the two groups ( P > 0.05 ) .
CONCLUSIONS	TUERP is better than TURP in the treatment of BPH for its advantages of higher resection rate of the prostate , shorter operation time and bladder irrigation time , less intraoperative blood loss , fewer postoperative complications , and faster recovery .

###25408735
BACKGROUND	Eradication of helicobacter pylori is important for treatment of GU but an ideal regimen is not available .
BACKGROUND	HP is resistant to metronidazole and clarithromycin .
BACKGROUND	Clarithromycin is expensive and is not available in under developing countries .
BACKGROUND	This study aimed to compare two regimens containing clarithromycin or azithromycin .
METHODS	Totally , seventy-eight patients with GU ( confirmed with endoscopy ) and infection of HP ( Confirmed by Rapid Urease Test ( RUT ) ) were allocated to one of the groups of study ( 35 participants in each group ) .
METHODS	Two weeks regimen of Clarithromycin ( 2500 mg ) + Amoxicillin ( 21 gr ) + omeprazole ( 220 mg ) was administered for group A of patients while group B got a 10 days regimen of Azithromycin ( 1250 mg ) + 14 days Amoxicillin ( 21 gr ) + omeprazole ( 220 mg ) .
METHODS	At the end of the treatment course , the patients were evaluated according to the side effects of the drugs .
METHODS	In addition , two months after the end of therapy , patients underwent endoscopy and biopsy to evaluate HP eradication .
RESULTS	After two weeks , the side effects of the drug were : Nausea 8 patients in group A and 7 patients in group B , Diarrhea 2 patients in group A , 3 patients in group B and vomiting 2 patients in group A , 3 patients in group B.
RESULTS	There were no serious side effects in any group .
RESULTS	Eradication rate in group A was 82.9 % ( based on per protocol analysis ( PPA ) ) and 84.6 % ( intention to treat ( ITT ) ) .
RESULTS	In group B , eradication rate was 77.1 % ( PPA ) and 79.5 % ( ITT ) ( P = 0.55 ) .
CONCLUSIONS	Based on our study results , azithromycin can be used in HP eradication regimen because of its similar efficacy to clarithromycin but also have lower cost , side effects and resistance .

###25653317
BACKGROUND	The purpose of this study was to determine whether surgery is an effective option for the treatment of stenosis of the lumbar spine and degenerative spondylolisthesis in the octogenarian population .
METHODS	An as-treated analysis of patients with lumbar stenosis and degenerative spondylolisthesis enrolled in the Spine Patient Outcomes Research Trial ( SPORT ) was performed .
METHODS	Patients who were at least eighty years of age ( n = 105 ) were compared with those younger than eighty years ( n = 1130 ) .
METHODS	Baseline patient and clinical characteristics were noted , and the difference in improvement from baseline between operative and nonoperative treatment was determined for each group at each follow-up time period up to four years .
RESULTS	There were no significant baseline differences in the primary or secondary patient-reported clinical outcome measures between the two patient age groups .
RESULTS	Patients at least eighty years of age had higher prevalences of multilevel stenosis , severe stenosis , and asymmetric motor weakness .
RESULTS	Patients at least eighty years of age also had higher prevalences of hypertension , heart disease , osteoporosis , and joint problems at baseline , but they had a lower body mass index and lower prevalences of depression and smoking .
RESULTS	Fifty-eight of the 105 patients at least eighty years of age and 749 of the 1130 younger patients underwent operative management .
RESULTS	There were no differences in the rates of intraoperative or postoperative complications , reoperation , or postoperative mortality between the older and younger groups .
RESULTS	Averaged over a four-year follow-up period , operatively treated patients at least eighty years of age had significantly greater improvement in all primary and secondary outcome measures compared with nonoperatively treated patients .
RESULTS	The treatment effects in patients at least eighty years of age were similar to those in younger patients for all primary and secondary measures except the SF-36 ( Short Form-36 ) bodily pain domain and the percentage who self-rated their progress as a major improvement , in both of which the treatment effect was significantly smaller .
CONCLUSIONS	Operative treatment of lumbar stenosis and degenerative spondylolisthesis offered a significant benefit over nonoperative treatment in patients at least eighty years of age ( p < 0.05 ) .
CONCLUSIONS	There were no significant increases in the complication and mortality rates following surgery in this patient population compared with younger patients ( p > 0.05 ) .

###24650825
OBJECTIVE	This trial investigated the effects of access to an Internet-based screening and brief intervention site for illicit drug users .
OBJECTIVE	This article adds to previously published results from the 3 - and 6-month follow-ups by extending the follow-up period to 12 months and reporting changes in substance use between the 6 - and 12-month follow-ups .
METHODS	In total , 202 Internet help-seekers with illicit drug use , 15-70 years old , were randomly assigned to either an intervention group that received Internet-based screening and brief intervention via eScreen.se or to an assessment-only control group .
METHODS	The primary outcome measure was the Drug Use Disorders Identification Test consumption questions ( DUDIT-C ) score , and secondary outcome measures were the DUDIT , Alcohol Use Disorders Identification Test consumption questions ( AUDIT-C ) , and AUDIT scores , as well as the proportion of drug abstainers and participants making a clinically significant change in their alcohol and other drug use .
RESULTS	DUDIT-C , DUDIT , AUDIT-C , and AUDIT scores remained stable between the 6 - and 12-month follow-ups .
RESULTS	However , 12 months after recruitment , 34.3 % of those who used eScreen.se had changed their alcohol use to a clinically lower level compared with the 21.8 % of the controls .
RESULTS	Also , none of the eScreen.se users increased their level of alcohol use during this 12-month period , whereas 5.0 % in the control group did so .
CONCLUSIONS	Despite no changes in illicit drug use from the 6 - to 12-month follow-up for both the intervention and control group , eScreen.se seems to be more effective than assessment only for reducing alcohol use among illicit drug users over a 12-month period .

###24331545
BACKGROUND	We previously reported rapid mood elevation following an experimental magnetic resonance imaging procedure in depressed patients with bipolar disorder ( BPD ) .
BACKGROUND	This prompted the design , construction , and testing of a portable electromagnetic device that reproduces only the rapidly oscillating ( 1 kHz , < 1 V/m ) electromagnetic field of the experimental procedure , called low field magnetic stimulation ( LFMS ) .
METHODS	We used a randomized , double blind , sham controlled treatment protocol to study the effects of LFMS in a large group of stably medicated , depressed patients with either BPD ( n = 41 ) or major depressive disorder ( n = 22 ) .
METHODS	Subjects received a single , 20-minute treatment .
METHODS	Change in mood was assessed immediately afterward using a visual analog scale ( VAS ) , the 17-item Hamilton Depression Rating Scale ( HDRS-17 ) , and the Positive and Negative Affect Schedule scales .
RESULTS	Substantial improvement ( > 10 % of baseline ) in mood was observed following LFMS treatment relative to sham treatment for both diagnostic subgroups for our primary outcomes , the VAS and the HDRS-17 .
RESULTS	These differences were not statistically significant in primary analyses stratifying by diagnosis but were significant in secondary analyses combining data across the two diagnostic groups ( p = .01 VAS , p = .02 HDRS-17 ) .
RESULTS	Rapid improvement in mood was also observed using the Positive and Negative Affect Schedule scales as secondary measures ( positive affect scale p = .02 BPD , p = .002 combined group ) .
RESULTS	A finite element method calculation indicates a broad penetration of the LFMS electric field throughout the cerebral cortex .
CONCLUSIONS	Low field magnetic stimulation may produce rapid changes in mood using a previously unexplored range of electromagnetic fields .

###25605203
BACKGROUND	Older age is associated with an increase in the incidence of cancer cases .
BACKGROUND	Diagnosis and treatment of cancer in older adults can be stressful because of health decline related to age , comorbidities and inadequate treatment for pain and other symptoms of the disease .
BACKGROUND	This survey is one of the unique studies in Jordan and in the Arab world that aimed at exploring the predictors of older adult individuals awareness towards cancer .
METHODS	A stratified random sampling technique was followed to reach a representative sample of 753 participants .
METHODS	The questionnaire of the study consisted of parts regarding demographic variables , awareness about screening tests , and signs and symptoms of cancer .
METHODS	In addition , specific questions related to factors linked to cancer were included .
METHODS	Cross-sectional design was adopted with face-to-face interviews at the interviewees ' households .
RESULTS	The mean age of the participants was about 63 years ; around 44 % of them are above the age of 65 years .
RESULTS	` Being convinced that having no health problem makes the individual feel safe and not at risk of getting cancer ' was the major reason for not doing a routine health check-up .
CONCLUSIONS	The low levels of awareness about cancer , as well as the low use of the screening methods were crucial outcomes of this study .
CONCLUSIONS	Thus , raising the awareness among health care providers and policy makers in the country about older adults ' perception of cancer is a high priority .

###24554545
BACKGROUND	Patients undergoing bariatric surgery are at high risk of postoperative nausea and vomiting ( PONV ) .
BACKGROUND	Despite triple PONV prophylaxis , up to 42.7 % of patients require antiemetic rescue medication ( AERM ) .
METHODS	This prospective , randomized study was conducted from November 2011 to October 2012 .
METHODS	In the Classic group ( n = 59 ) , patients underwent general anaesthesia with volatile anaesthetics and opioids .
METHODS	In the Total i.v. anaesthesia ( TIVA ) group ( n = 60 ) , patients underwent opioid-free TIVA with propofol , ketamine , and dexmedetomidine .
METHODS	The severity of PONV was assessed using a Likert scale ( none , mild , moderate , and severe ) .
RESULTS	Patients in both groups had similar clinical characteristics , surgical procedure , and PONV risk scores and required similar amounts of postoperative opioid .
RESULTS	In the Classic group , 22 patients ( 37.3 % ) reported PONV compared with 12 patients ( 20.0 % ) in the TIVA group [ P = 0.04 ; risk 1.27 ( 1.01-1 .61 ) ] .
RESULTS	The absolute risk reduction was 17.3 % ( number-needed-to-treat = 6 ) .
RESULTS	The severity of nausea was statistically different in both groups ( P = 0.02 ) .
RESULTS	The severity of PONV was significantly worse in the Classic group .
RESULTS	There was no difference either in the number of patients requiring AERM in the postoperative period or in the number of AERM doses required .
CONCLUSIONS	This prospective randomized study demonstrates that opioid-free TIVA is associated with a large reduction in relative risk of PONV compared with balanced anaesthesia .
CONCLUSIONS	Clinical trial registration NCT 01449708 ( ClinicalTrials.gov ) .

###26308758
BACKGROUND	Helicobacter pylori ( H pylori ) is strongly associated with the development of gastritis , duodenal and gastric ulcers , gastric mucosa-associated lymphoid tissue ( MALT ) lymphomas and gastric carcinoma .
BACKGROUND	Emerging antibiotic resistance and patients ' poor compliance with modern therapies have resulted in increasing eradication failure .
OBJECTIVE	The current trial was conducted to evaluate the efficacy of current quadruple and phytomedicine-based therapies for the eradication of H pylori infection and relief of its associated symptoms in Pakistan .
METHODS	The study was a randomized , controlled , multicenter clinical trial .
METHODS	Setting The study was conducted in high-risk areas of Pakistan , including at Shifa-Ul-Mulk Memorial Hospital in Karachi , at Bahawalpur Victoria Hospital in Bahawalpur , and at Nawaz Salik Hospital in Rawalpindi .
METHODS	The study enrolled 210 patients who tested positive for H pylori , 118 males and 92 females .
METHODS	Participants were divided into 2 groups according to treatment regimens .
METHODS	One group of participants received quadruple therapy-20 mg of omeprazole , 1g of amoxicillin , 500 mg of metronidazole , and 400 mg of bismuth compound-that was prescribed for 7 d , and another group received an alternate , phytomedicine-based , quadruple formulation-500 mg of Pylorex Plus-that was prescribed for 15 d.
METHODS	The eradication rate for H pylori was the primary outcome measure .
METHODS	Eradication was considered to be achieved on the basis of a negative C-urea breath test ( UBT ) and a negative stool antigen test for H pylori ( HpSAg ) at 4 wk after the end of treatment .
METHODS	The secondary outcome measure was the improvement in the clinical features as assessed by dyspepsia scores .
RESULTS	In an intention-to-treat ( ITT ) analysis , the study found that H pylori was eradicated in 56 of the 90 participants in the quadruple therapy group who completed the study ( 62.2 % ) and in 48 of the 86 participants in the Pylorex Plus group who completed the study ( 55.8 % ) .
RESULTS	Therefore , Pylorex Plus had an eradication rate comparable with quadruple therapy .
RESULTS	However , Pylorex Plus had significantly reduced gastrointestinal ( GI ) symptoms at the second wk and at 1 mo after treatment , both for participants in whom H pylori was eradicated and for those in whom it was not eradicated .
RESULTS	The quadruple therapy group also showed reduced GI symptoms at the second wk and at 1 mo after treatment , but that result occurred only for those participants in whom H pylori was eradicated , and no significant improvement was observed for participants in whom it was not eradicated .
CONCLUSIONS	Current quadruple and alternate therapies yielded poor eradication rates ( < 70 % ) , but the latter produced marked symptomatic improvement , both for participants in whom H pylori was eradicated and for those in whom it was not eradicated , pointing out its potential use with patients with functional dyspepsia ( FD ) who are both positive and negative for H pylori .

###25099306
OBJECTIVE	Effective communication is needed for optimal cancer pain management .
OBJECTIVE	This study assessed the efficacy of a general communication skills training program for oncology nurses on communication about pain management .
METHODS	A total of 115 nurses were randomly assigned to a training group ( TG ) or control group ( CG ) .
METHODS	The assessment included the recording of interviews with a simulated cancer patient at baseline for both groups and after training ( TG ) or 3 months after baseline ( CG ) .
METHODS	Two psychologists rated the content of interview transcripts to assess cancer pain management communication .
METHODS	Group-by-time effects were measured using a generalized estimating equation .
RESULTS	Trained nurses asked the simulated patient more questions about emotions associated with pain ( relative rate [ RR ] = 4.28 , p = 0.049 ) and cognitions associated with pain treatment ( RR = 3.23 , p < 0.001 ) and used less paternalistic statements about cancer pain management ( RR = 0.40 , p = 0.006 ) compared with untrained nurses .
CONCLUSIONS	The general communication skills training program improved only a few of the communication strategies needed for optimal cancer pain management in nursing .
CONCLUSIONS	General communication skills training programs should be consolidated using specific modules focusing on communication skills related to cancer pain management .

###24810796
BACKGROUND	Early and adequate atropine administration in organophosphorus ( OP ) or carbamate insecticide poisoning improves outcome .
BACKGROUND	However , some authors advise that oxygen must be given before atropine due to the risk of inducing ventricular dysrhythmias in hypoxic patients .
BACKGROUND	Because oxygen is frequently unavailable in district hospitals of rural Asia , where the majority of patients with insecticide poisoning present , this guidance has significant implications for patient care .
BACKGROUND	The published evidence for this advice is weak .
BACKGROUND	We therefore performed a patient cohort analysis to look for early cardiac deaths in patients poisoned by anticholinesterase pesticides .
METHODS	We analysed a prospective Sri Lankan cohort of OP or carbamate-poisoned patients treated with early atropine without the benefit of oxygen for evidence of early deaths .
METHODS	The incidence of fatal primary cardiac arrests within 3 h of admission was used as a sensitive ( but non-specific ) marker of possible ventricular dysrhythmias .
RESULTS	The cohort consisted of 1957 patients .
RESULTS	The incidence of a primary cardiac death within 3 h of atropine administration was 4 ( 0.2 % ) of 1957 patients .
RESULTS	The majority of deaths occurred at a later time point from respiratory complications of poisoning .
CONCLUSIONS	We found no evidence of a high number of early deaths in an observational study of 1957 patients routinely given atropine before oxygen that might support guidance that oxygen must be given before atropine .
CONCLUSIONS	The published literature indicates that early and rapid administration of atropine during resuscitation is life-saving .
CONCLUSIONS	Therefore , whether oxygen is available or not , early atropinisation of OP - and carbamate-poisoned patients should be performed .

###25733649
BACKGROUND	Moderate acute malnutrition ( MAM ) , defined as weight-for-length z score between -3 and -2 or midupper arm circumference between 11.5 and 12.5 cm , affects 33 million children aged < 5 y worldwide .
OBJECTIVE	The objective was to compare the effects of 4 dietary supplements for the treatment of MAM .
METHODS	Twelve community health centers in rural Mali were randomly assigned to provide to 1264 MAM children aged 6-35 mo one of 4 dietary supplements containing 500 kcal/d for 12 wk : 1 ) ready-to-use , lipid-based supplementary food ( RUSF ) ; 2 ) special corn-soy blend ( CSB + + ) ; 3 ) locally processed , fortified flour ( Misola ) ; or 4 ) locally milled flours plus oil , sugar , and micronutrient powder ( LMF ) .
RESULTS	In total , 1178 children ( 93.2 % ) completed the study .
RESULTS	The adjusted mean ( 95 % CI ) change in weight ( kg ) from baseline was greater with RUSF than with the locally processed blends and was intermediate with CSB + + [ 1.16 ( 1.08 , 1.24 ) for RUSF , 1.04 ( 0.96 , 1.13 ) for CSB + + , 0.91 ( 0.82 , 0.99 ) for Misola , and 0.83 ( 0.74 , 0.92 ) for LMF ; P < 0.001 ] .
RESULTS	For length change , RUSF and CSB + + differed significantly from LMF .
RESULTS	Sustained recovery rates were higher with RUSF ( 73 % ) than with Misola ( 61 % ) and LMF ( 58 % ) , P < 0.0001 ; CSB + + recovery rates ( 68 % ) did not differ from any of the other groups .
CONCLUSIONS	RUSF was more effective , but more costly , than other dietary supplements for the treatment of MAM ; CSB + + yielded intermediate results .
CONCLUSIONS	The benefits of treatment should be considered in relation to product costs and availability .

###25102685
OBJECTIVE	To research the curative effect of Chinese herbs for clearing away heat , promoting diuresis , nourishing the kidney , and consolidating essence in children with Henoch-Schonlein purpura nephritis ( HSPN ) with internal accumulation of damp-toxin using randomized controlled observations on large samples .
OBJECTIVE	To seek the mechanism of the therapy and its scope of indications .
METHODS	Overall , 186 children with HSPN were randomly divided into two groups : treatment group ( n = 126 ) treated with Chinese herbs for clearing heat and promoting diuresis and a control group ( n = 60 ) treated with Western Medicine .
METHODS	The treatment was carried out for three courses of 4 weeks each .
METHODS	We recorded changes in patient urine routines , 24 h urinary protein , blood-coagulating series , immunoglobulin and T-cell subgroups , and improvements in main symptoms .
METHODS	We evaluated the alleviation of clinical symptoms and the improvement of proteinuria , hematuria , and other laboratory test results .
METHODS	Finally , we analyzed the patient population suitable for this therapy according to the relationship between the grouping of patient body weight and curative effect .
RESULTS	Damp-heat syndrome improved in the treatment group , with a significant difference in total effective rate after a 4-week treatment ( chi2 = 13.5220 , P = 0.0002 ) and in curative rate after a 12-week treatment ( chi2 = 6.3410 , P = 0.0118 ) , compared to those in the control group .
RESULTS	The curative effect in the treatment group was greater than that in the control group but there was no statistical difference between the two groups .
RESULTS	The curative effect after a 4-week treatment of patients in the treatment group weighing 30 kg or less based on Traditional Chinese Medicine ( TCM ) signs and urinary protein was significantly greater than that in the control group .
RESULTS	However , there was no statistical difference in the curative effect on urinary red cells and various indexes after a 12-week treatment between the two groups .
CONCLUSIONS	Therapy for clearing away heat , promoting diuresis , nourishing the kidney , and consolidating essence using TCM is effective in children with HSPN from internal accumulation of damp-toxin .
CONCLUSIONS	The therapy is especially suitable for patients weighing 30 kg or less .
CONCLUSIONS	The curative effect may be related to the improvement of immune function and blood-coagulation .

###25884922
BACKGROUND	Cognitive behavioural therapy ( CBT ) is recommended for the treatment of depression and anxiety .
BACKGROUND	However , access is limited .
BACKGROUND	Low-intensity approaches such as guided CBT self-help ( bibliotherapy ) can increase access to treatment and is recommended by UK guidelines .
BACKGROUND	No previous research has explored the provision of group-based guidance/support for a bibliotherapy approach for depression and anxiety in community settings .
BACKGROUND	The objective was to carry out a pilot study of a group guided self-help intervention , using community based recruitment methods .
METHODS	A randomised controlled trial comparing an 8week CBT group guided self-help intervention to usual care .
METHODS	Recruitment and the delivery of the intervention were carried out in Glasgow and Derry/Londonderry in partnership with national depression charities .
METHODS	Fifty-three people were randomised , however we refer only to the forty-six participants who provided baseline data : 16 males and 30 females , aged 16 or over , with a PHQ-9 score of5 , were recruited from the community .
METHODS	The mean age of the sample was 43.7 ( sd = 13 ) and 93.5 % of participants had suffered from low mood for a year or more .
RESULTS	There was effective recruitment , randomisation , uptake and adherence with 21 Immediate Access ( IA ) and 25 Delayed Access Control ( DAC ) participants .
RESULTS	The intervention was highly acceptable to participants attending on average 4.46 of the 8 sessions ( sd 3.06 ) , 65.2 % attended more than half of all sessions .
RESULTS	The mean satisfaction on the Client Satisfaction Questionnaire was 28 out of 32 ( sd 4.8 ) .
RESULTS	The provisional results in the pilot suggest the intervention may improve both anxiety and depression .
RESULTS	At three months , data collection was achieved from 74 % of participants .
RESULTS	The trial successfully provided estimates of the sample size needed for the future planned trial .
CONCLUSIONS	Low-intensity group-based classes may offer an alternative method of managing depression and anxiety and warrant further research .
BACKGROUND	Current Controlled Trials ISRCTN84893887 .
BACKGROUND	Registered 3 November 2011 .

###25285937
OBJECTIVE	To compare larvicidal regimens of fenbendazole and moxidectin for reduction and suppression of cyathostomin fecal egg counts ( FEC ) in a transient herd of embryo transfer-recipient mares .
METHODS	Randomized , complete block , clinical trial .
METHODS	120 mares from 21 states , residing on 1 farm .
METHODS	An initial fecal sample was collected from each mare ; mares with an FEC 200 eggs/g were assigned to treatment groups .
METHODS	Eighty-two horses received fenbendazole ( 10.0 mg/kg [ 4.5 mg/lb ] , PO , q 24 h for 5 days ) or moxidectin ( 0.4 mg/kg [ 0.18 mg/lb ] , PO , once ) ; FEC data were analyzed 14 , 45 , and 90 days after treatment .
RESULTS	Mean FEC reduction was 99.9 % for moxidectin-treated mares and 41.9 % for fenbendazole-treated mares 14 days after treatment .
RESULTS	By 45 days , mean FEC of fenbendazole-treated mares exceeded pretreatment counts ; however , FECs of moxidectin-treated mares remained suppressed below pretreatment values for the duration of the 90-day study .
RESULTS	Fecal egg counts were significantly different between groups at 14 , 45 , and 90 days after treatment .
CONCLUSIONS	Failure of the 5-day regimen of fenbendazole to adequately reduce or suppress FEC suggested inadequate adulticidal and larvicidal effects .
CONCLUSIONS	In contrast , a single dose of moxidectin effectively reduced and suppressed FEC for an extended period .
CONCLUSIONS	Given the diverse geographic origins of study mares , these results are likely representative of cyathostomin-infected mares in much of the United States , confirming previous findings indicating that fenbendazole resistance in cyathostomins is widespread and that moxidectin remains an effective treatment for control of these important parasites .

###24531755
OBJECTIVE	The aim of the present study was to investigate the effects of the consumption of two cloudy apple juices with different polyphenol and vitamin C contents on antioxidant status , cardiometabolic and inflammation markers in healthy young adults .
METHODS	Twenty subjects , aged 21-29 years , completed a randomized crossover study .
METHODS	At each 4-week intervention period , the volunteers randomly consumed two glasses ( 2 250 mL/day ) of either a vitamin C-rich apple juice ( VCR ) ( 60 mg/L vitamin C and 510 mg catechin equivalent/L ) or a polyphenol-rich ( PR ) juice ( 22 mg/L vitamin C and 993 mg catechin equivalent/L ) .
METHODS	Blood and urine samples were collected throughout the study , and markers of antioxidant status , glucose metabolism , lipid profile and inflammation were measured .
RESULTS	The comparison of the post-intervention minus pre-intervention change revealed differential results in HOMA index , total cholesterol , ICAM-1 and VCAM-1 ( P < 0.05 ) across juices .
RESULTS	During the VCR period , plasma antioxidant activity ( FRAP ) increased ( P = 0.031 ) , while ICAM-1 and total cholesterol showed a trend to decrease ( P = 0.060 and P = 0.094 , respectively ) .
RESULTS	During the PR period , plasma insulin and HOMA increased , and total glutathione decreased ( P < 0.05 ) .
CONCLUSIONS	A joint consumption of apple juice natural antioxidants such as vitamin C and polyphenols might provide mild favorable effects on cardiometabolic markers , as compared to apple polyphenols alone .

###26062187
OBJECTIVE	To compare the differences of clinical effects on primary hypertension between acupuncture combined with auricular point sticking and western medicine .
METHODS	Ninety patients with primary hypertension were randomly divided into a medication group and a combination group , 45 cases in each group .
METHODS	In the medication group , captopril tablets were treated with oral administration , 12.5 mg each time , twice a day ; in the combination group , acupuncture and auricular point sticking were used , and acupuncture was applied at Renying ( ST 9 ) , Fengchi ( GB 20 ) and Baihui ( GV 20 ) , while auricular point sticking was adopted at Shenmen ( TF4 ) , Xin ( CO15 ) , Jiangyagou and Jiaogan ( AH6a ) , once a day for continuous 4 weeks .
METHODS	After treatment , the changes of 24 h ambulatory blood pressure , angiotensin II ( Ang II ) level , creatinine level and syndrome scores were observed and the clinical efficacy was assessed in the two groups .
RESULTS	After 4 weeks ' treatment , the 24 h ambulatory blood pressure was both improved compared with that before treatment in the two groups ( P < 0.01 , P < 0.05 ) .
RESULTS	The reducing of 24 h ambulatory blood pressure in the combination group was superior to that in the medication group ( P < 0.05 ) .
RESULTS	There were reducing tendencies about coefficients of variation ( CVs ) of the two groups , and in the combination group , the CVs of 24 h ambulatory blood pressure and systolic pressure acquired more obvious reducing range compared with the medication group ( both P < 0.05 ) .
RESULTS	Serum Ang II level and plasma creatinine level of the patients in the two groups after treatment were both decreased ( both P < 0.05 ) and the reducing of Ang II level and creatinine level of the combination group was more obvious than that of the medication group ( both P < 0.05 ) .
RESULTS	The syndrome scores of the two groups after treatment were both remarkably decreased ( both P < 0.05 ) , and the reducing of the syndrome scores of the combination group was more marked than that of the medication group ( P < 0.05 ) .
RESULTS	The total effective rate of the combination group was 95.6 % ( 43/45 ) , which was superior to 71.1 % ( 32/45 ) of the medication group ( P < 0.05 ) .
CONCLUSIONS	Acupuncture combined with auricular point sticking for primary hypertension has reliable effect .
CONCLUSIONS	It is better than captopril for the improvement of 24 h ambulatory blood pressure , AngII level and creatinine level , and can improve dizzy , palpitation and other clinical symptoms .

###24914426
OBJECTIVE	To evaluate the effects of fluoride varnish vs a combination of chlorhexidine-thymol varnish plus a gel containing chlorhexidine and fluoride on oral hygiene and caries prevention in disabled children .
METHODS	Ninety patients aged 3-17 years who were treated under general anaesthesia were randomly assigned into three groups as follows : group 1 : Fluor Protector ( 0.1 % fluoride varnish ) ; group 2 : Cervitec Plus ( 1 % chlorhexidine - 1 % thymol varnish ) + Cervitec Gel ( 0.2 % chlorhexidine-0 .2 % sodium fluoride ) ; group 3 : control ( toothbrushing only ) .
METHODS	Mutans streptococci ( MS ) and lactobacilli ( LB ) levels , visible plaque index ( VPI ) and gingival bleeding index ( GBI ) were evaluated at four stages : T0 , before general anaesthesia ; T1 , one month after treatment ; T2 , six months after treatment ; T3 , twelve months after treatment .
METHODS	The data were evaluated using Kruskal-Wallis and Mann-Whitney U-tests ( P < 0.05 ) .
RESULTS	Groups 1 and 2 showed significantly lower scores than group 3 for all parameters at T1 and T2 .
RESULTS	No statistically significant difference was detected among any of the the groups at T3 ( P > 0.05 ) .
CONCLUSIONS	The use of materials that include both fluoride and chlorhexidine as routine treatment of children with disability may increase the success of restorations by improving oral hygiene , reduce the need for future restorative treatments and thus the need for general anaesthesia .

###25348809
BACKGROUND	The Crohn 's Disease Activity Index ( CDAI ) is a measure of disease activity based on symptoms , signs and a laboratory test .
BACKGROUND	The US Food and Drug Administration has indicated that patient reported outcomes ( PROs ) should be the primary outcome in randomised controlled trials for Crohn 's disease ( CD ) .
OBJECTIVE	As no validated PRO exists for CD , to investigate whether CDAI diary card items could be modified for this purpose .
METHODS	Data from a trial of rifaximin-extended intestinal release were used to identify cut-points for stool frequency , pain and general well-being using receiver operating characteristic curves with CDAI < 150 as criterion .
METHODS	The operating properties of 2 - and 3-item PRO were evaluated using data from a trial of methotrexate in CD .
METHODS	Regression analysis determined PRO2 and PRO3 scores that correspond to CDAI-defined thresholds of 150 , 220 and 450 and changes of 50 , 70 and 100 points .
RESULTS	Optimum cut-points for CDAI remission were mean daily stool frequency 1.5 , abdominal pain 1 , and general well-being score of 1 ( areas under the ROC curve 0.79 , 0.91 and 0.89 , respectively ) .
RESULTS	The effect estimates were similar using 2 - and 3-item PROs or CDAI .
RESULTS	PRO2 and PRO3 values corresponding to CDAI scores of 150 , 220 and 450 points were 8 , 14 , 34 and 13 , 22 , 53 .
RESULTS	The corresponding values for CDAI changes of 50 , 70 and 100 , were 2 , 5 , 8 and 5 , 9 , 14 .
RESULTS	Responsiveness to change was similar for both PROs .
CONCLUSIONS	Patient reported outcomes derived from CDAI diary items may be appropriate for use in clinical trials for CD .

###24529550
OBJECTIVE	To determine whether the use of a paclitaxel-coated balloon ( PCB ) improves patency in patients undergoing percutaneous transluminal angioplasty ( PTA ) for recurrent juxtaanastomotic stenosis of radiocephalic arteriovenous fistulas ( RCAVFs ) .
METHODS	This prospective study recruited hemodialysis patients with two short ( < 2 cm ) and separated inflow RCAVF lesions .
METHODS	After dilation of lesions using a 4-mm plain balloon ( PB ) , half of the lesions were randomly selected for treatment with PTA using PCB ( size , 4 mm ; length , 2 cm ) and PB ( size , 5-mm or 6-mm ) ( group 1 ) , and the other half were treated with PTA using PB alone ( group 2 ) .
METHODS	After the index PTA , dysfunction-driven angiography was performed to confirm target lesion restenosis ( TLR ) .
METHODS	TLR and lesion patency were compared in the two groups by ( 2 ) test , t test , and Kaplan-Meier analysis .
RESULTS	The analysis of 20 lesions in 10 patients revealed that the TLR-free duration in group 1 was significantly longer than the TLR-free duration in group 2 ( 251.2 d vs 103.2 d ; P < .01 ) .
RESULTS	The patency rate of the target lesion was significantly higher in group 1 than in group 2 at 6 months ( 70 % vs 0 % ; P < .01 ) but not at 12 months ( 20 % vs 0 % ; P > .05 ) .
CONCLUSIONS	This early study suggests that , for improving short-term patency , PTA with PCB and PB is more effective than PTA with PB alone , warranting further study .

###25637811
BACKGROUND	Olfaction plays an important role in mammalian social behavior .
BACKGROUND	Olfactory deficits are common in schizophrenia and correlate with negative symptoms and low social drive .
BACKGROUND	Despite their prominence and possible clinical relevance , little is understood about the pathological mechanisms underlying olfactory deficits in schizophrenia and there are currently no effective treatments for these deficits .
BACKGROUND	The prosocial neuropeptide oxytocin may affect the olfactory system when administered intranasally to humans and there is growing interest in its therapeutic potential in schizophrenia .
METHODS	To examine this model , we administered 40IU of oxytocin and placebo intranasally to 31 patients with a schizophrenia spectrum illness and 34 age-matched healthy control participants in a randomized , double-blind , placebo-controlled , cross-over study .
METHODS	On each test day , participants completed an olfactory detection threshold test for two different odors : ( 1 ) lyral , a synthetic fragrance compound for which patients with schizophrenia have specific olfactory detection threshold deficits , possibly related to decreased cyclic adenosine 3 ' ,5 ' - monophosphate ( cAMP ) signaling ; and ( 2 ) anise , a compound for which olfactory detection thresholds change with menstrual cycle phase in women .
RESULTS	On the placebo test day , patients with schizophrenia did not significantly differ from healthy controls in detection of either odor .
RESULTS	We found that oxytocin administration significantly and selectively improved olfactory detection thresholds for lyral but not for anise in patients with schizophrenia .
RESULTS	In contrast , oxytocin had no effect on detection of either odor in healthy controls .
CONCLUSIONS	Our data indicate that oxytocin administration may ameliorate olfactory deficits in schizophrenia and suggest the effects of intranasal oxytocin may extend to influencing the olfactory system .
CONCLUSIONS	Given that oxytocin has been found to increase cAMP signaling in vitro a possible mechanism for these effects is discussed .

###25344703
BACKGROUND	Group reminiscence therapy is a brief and structured intervention in which participants share personal past events with peers .
BACKGROUND	This approach has been shown to be promising for improving wellbeing and reducing depressive symptoms among institutionalized older adults .
BACKGROUND	However , despite the considerable interest in reminiscence group therapy , controlled studies to determine its specific benefits as compared to generic social interactions with peers ( group conversations about everyday subjects ) are still lacking .
METHODS	We have designed a randomized controlled trial aimed at comparing the effects of group reminiscence therapy with those of group recreational activity on the psychological wellbeing of an institutionalized sample of older adults .
METHODS	The study includes two groups of 20 hospitalized elderly participants : the experimental group and the control group .
METHODS	Participants included in the experimental group will receive six sessions of group reminiscence therapy , while the control group will participate in a recreational group discussion .
METHODS	A repeated-measures design will be used post-intervention and three months post-intervention to evaluate changes in self-reported outcome measures of depressive symptoms , self-esteem , life satisfaction , and quality of life from baseline .
CONCLUSIONS	The protocol of a study aimed at examining the specific effects of group reminiscence therapy on psychological wellbeing , depression , and quality of life among institutionalized elderly people is described .
CONCLUSIONS	It is expected that the outcomes of this trial will contribute to our knowledge about the process of group reminiscence , evaluate its effectiveness in improving psychological wellbeing of institutionalized individuals , and identify the best conditions for optimizing this approach .
BACKGROUND	This trial was registered with ClinicalTrials.gov ( registration number : NCT02077153 ) on 31 January 2014 .

###25411292
BACKGROUND	Elevated serum low-density lipoprotein ( LDL ) cholesterol is a predictor of cardiovascular disease events , and the quality of dietary fat is known to influence serum concentrations of LDL cholesterol in children .
BACKGROUND	Interindividual differences in response to diet exist , but the underlying genetic factors remain largely unknown .
OBJECTIVE	We aimed to identify genetic variants that modify the variation in serum lipid response to dietary fat quality .
METHODS	We used data from 2 longitudinal Finnish cohorts designed to study risk factors for cardiovascular diseases .
METHODS	Large-scale genotyping was performed with Metabochip in a long-term randomized controlled dietary intervention trial , the Special Turku Coronary Risk Factor Intervention Project ( STRIP ) , for discovery of genetic polymorphisms .
METHODS	The observational Cardiovascular Risk in Young Finns Study ( YFS ) with genome-wide genetic data was used as a replication sample for the initial findings .
METHODS	Dietary records were used to calculate the ratio of unsaturated to saturated fats .
METHODS	Interaction models and multiple follow-ups were used in the analysis .
RESULTS	In the STRIP cohort , a variant within the PARK2 locus , rs9364628 , showed moderate interaction with dietary fat quality and a consistent direction of effect in both scans on serum LDL-cholesterol concentration in children aged 5 and 7 y ( P < 0.0084 and P < 0.0057 , respectively ) .
RESULTS	In the YFS cohort , we were unable to replicate the initial discovery signal , but rs12207186 within the PARK2 locus and dietary lipid quality had a stronger interaction effect on serum LDL-cholesterol concentration ( P < 9.44 10 ( -5 ) ) than did rs9364628 in children aged 6 y.
CONCLUSIONS	This genotyping study involving 2 cohorts of healthy Finnish children indicates a possible interaction between PARK2 variants and dietary fat quality on serum LDL-cholesterol concentration .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT00223600 .

###25272318
OBJECTIVE	To compare the efficacy of panretinal photocoagulation ( PRP ) and intravitreal ranibizumab injection with PRP alone in patients with treatment-naive bilateral non-high-risk proliferative diabetic retinopathy .
METHODS	Sixty eyes of 30 patients were randomized either to the study group ( SG ) receiving PRP plus 2 ranibizumab injections or to the control group ( CG ) receiving PRP alone .
METHODS	Mean change in best-corrected visual acuity and in optical coherence tomography were compared at baseline and 1 , 3 , and 6 months .
RESULTS	Best-corrected visual acuity was significantly better at 6 months in the SG ; however , there was decrease in best-corrected visual acuity in the CG .
RESULTS	Central macula thickness decreased significantly at 6 months in SG when compared with baseline ( -47.6 m , P < 0.001 ) and did not reveal significant difference in the CG .
RESULTS	In eyes with diabetic macular edema , best-corrected visual acuity increased by 3.6 letters ( P = 0.06 ) in the SG and decreased by 4.4 letters in the CG ( P = 0.003 ) .
RESULTS	Central macula thickness decreased by 69.3 m ( P = 0.001 ) in the SG and decreased by 45.5 m ( P = 0.11 ) in the CG .
CONCLUSIONS	Intravitreal ranibizumab in combination with PRP can be an effective treatment in eyes with non-high-risk proliferative diabetic retinopathy and diabetic macular edema .

###24790069
OBJECTIVE	Central blood pressure ( CBP ) and carotid intima-media thickness ( CIMT ) are surrogate measures of cardiovascular risk .
OBJECTIVE	Allopurinol reduces serum uric acid and oxidative stress and improves endothelial function and may therefore reduce CBP and CIMT progression .
OBJECTIVE	This study sought to ascertain whether allopurinol reduces CBP , arterial stiffness and CIMT progression in patients with ischaemic stroke or transient ischaemic attack ( TIA ) .
METHODS	We performed a randomised , double-blind , placebo-controlled study , examining the effect of 1-year treatment with allopurinol ( 300mg daily ) , on change in CBP , arterial stiffness and CIMT progression at 1year and change in endothelial function and circulating inflammatory markers at 6months .
METHODS	Patients aged over 18years with recent ischaemic stroke or TIA were eligible .
RESULTS	Eighty participants were recruited , mean age 67.8 years ( SD 9.4 ) .
RESULTS	Systolic CBP [ -6.6 mmHg ( 95 % CI -13.0 to -0.3 ) , p = 0.042 ] and augmentation index [ -4.4 % ( 95 % CI -7.9 to -1.0 ) , p = 0.013 ] were each lower following allopurinol treatment compared with placebo at 12months .
RESULTS	Progression in mean common CIMT at 1year was less in allopurinol-treated patients compared with placebo [ between-group difference [ -0.097 mm ( 95 % CI -0.175 to -0.019 ) , p = 0.015 ] .
RESULTS	No difference was observed for measures of endothelial function .
CONCLUSIONS	Allopurinol lowered CBP and reduced CIMT progression at 1year compared with placebo in patients with recent ischaemic stroke and TIA .
CONCLUSIONS	This extends the evidence of sustained beneficial effects of allopurinol to these prognostically significant outcomes and to the stroke population , highlighting the potential for reduction in cardiovascular events with this treatment strategy .
BACKGROUND	ISRCTN11970568 .

###25248371
BACKGROUND	Malnutrition is a common complication in patients at the palliative stage of cancer .
BACKGROUND	During the curative phase of cancer , optimal enteral or parenteral nutrition intake can reduce morbidity and mortality , and improve quality of life .
BACKGROUND	When the main goal of treatment becomes palliative , introduction of artificial nutrition is controversial .
BACKGROUND	Although scientific societies do not recommend the introduction of artificial nutrition in all cases of malnutrition , especially in hypophagic patients if their life expectancy is shorter than 2 months , considerable differences in the use of parenteral nutrition in nonsurgical oncology practice are noted around the world .
BACKGROUND	One explanation is a paucity of well-conducted randomized controlled trials in these situations , and consequently , the risk/benefit ratio of parenteral nutrition and its impact on quality of life in palliative care remains uncertain .
METHODS	The ALIM-K study is a French national multicenter randomized controlled trial designed to evaluate the effectiveness of parenteral nutrition , versus an exclusive oral-feeding supply , on the quality of life of malnourished patients who have a functional digestive tube and who are at the palliative phase of advanced cancer with a life expectancy of more than 2 months .
CONCLUSIONS	This article presents the methodologic options chosen for our study , and in particular , the choice of the Zelen method of randomization , the definition of the main end point ( quality of life ) , the choice of comparator ( oral feeding ) , and the inclusion criteria ( life expectancy of more than 2 months ) , which are all critical points in building a randomized controlled trial in the setting of palliative care .
BACKGROUND	This study was registered with the clinical trials database ClinicalTrials.gov on May 27 , 2014 , under the number NCT02151214 .

###24240712
OBJECTIVE	Hospital cooling improves outcome after cardiac arrest , but prehospital cooling immediately after return of spontaneous circulation may result in better outcomes .
OBJECTIVE	To determine whether prehospital cooling improves outcomes after resuscitation from cardiac arrest in patients with ventricular fibrillation ( VF ) and without VF .
METHODS	A randomized clinical trial that assigned adults with prehospital cardiac arrest to standard care with or without prehospital cooling , accomplished by infusing up to 2 L of 4C normal saline as soon as possible following return of spontaneous circulation .
METHODS	Adults in King County , Washington , with prehospital cardiac arrest and resuscitated by paramedics were eligible and 1359 patients ( 583 with VF and 776 without VF ) were randomized between December 15 , 2007 , and December 7 , 2012 .
METHODS	Patient follow-up was completed by May 1 , 2013 .
METHODS	Nearly all of the patients resuscitated from VF and admitted to the hospital received hospital cooling regardless of their randomization .
METHODS	The primary outcomes were survival to hospital discharge and neurological status at discharge .
RESULTS	The intervention decreased mean core temperature by 1.20 C ( 95 % CI , -1.33 C to -1.07 C ) in patients with VF and by 1.30 C ( 95 % CI , -1.40 C to -1.20 C ) in patients without VF by hospital arrival and reduced the time to achieve a temperature of less than 34C by about 1 hour compared with the control group .
RESULTS	However , survival to hospital discharge was similar among the intervention and control groups among patients with VF ( 62.7 % [ 95 % CI , 57.0 % -68.0 % ] vs 64.3 % [ 95 % CI , 58.6 % -69.5 % ] , respectively ; P = .69 ) and among patients without VF ( 19.2 % [ 95 % CI , 15.6 % -23.4 % ] vs 16.3 % [ 95 % CI , 12.9 % -20.4 % ] , respectively ; P = .30 ) .
RESULTS	The intervention was also not associated with improved neurological status of full recovery or mild impairment at discharge for either patients with VF ( 57.5 % [ 95 % CI , 51.8 % -63.1 % ] of cases had full recovery or mild impairment vs 61.9 % [ 95 % CI , 56.2 % -67.2 % ] of controls ; P = .69 ) or those without VF ( 14.4 % [ 95 % CI , 11.3 % -18.2 % ] of cases vs 13.4 % [ 95 % CI ,10.4 % -17.2 % ] of controls ; P = .30 ) .
RESULTS	Overall , the intervention group experienced rearrest in the field more than the control group ( 26 % [ 95 % CI , 22 % -29 % ] vs 21 % [ 95 % CI , 18 % -24 % ] , respectively ; P = .008 ) , as well as increased diuretic use and pulmonary edema on first chest x-ray , which resolved within 24 hours after admission .
CONCLUSIONS	Although use of prehospital cooling reduced core temperature by hospital arrival and reduced the time to reach a temperature of 34C , it did not improve survival or neurological status among patients resuscitated from prehospital VF or those without VF .
BACKGROUND	clinicaltrials.gov Identifier : NCT00391469 .

###25516091
BACKGROUND	Improving management of patients suffering from cerebral malaria is needed to reduce the devastating mortality and morbidity of the disease in endemic areas .
BACKGROUND	Intravenous artesunate is currently the first-line treatment , but the lack of material and skills in the field make it difficult to implement in endemic areas .
BACKGROUND	Intranasal route provides a very easy and direct gateway to blood and brain to deliver medications , by-passing the brain blood barrier .
BACKGROUND	Therefore , it could be helpful and suitable to administer artesunate in the context of cerebral malaria , especially in young children .
BACKGROUND	In this study , intranasal administration of artesunate to rescue from cerebral malaria using a murine model was tested .
METHODS	CBA/J mice infected with Plasmodium berghei ANKA strain received artesunate ( 20 mg/kg ) or a placebo solution intranasally , either on day 5 , 6 or 7 post-infection , during a controlled , blinded , randomized trial .
METHODS	Primary endpoint was mortality on day 12 post-infection .
METHODS	Secondary endpoints were parasitaemia and clinical stage .
METHODS	Pharmacokinetics data following administration were collected in blood and brains of treated mice .
METHODS	Local toxicity was evaluated by histopathologic examination of brain and nasal sections in blinded manner .
RESULTS	Intranasal administration of artesunate dramatically reduced the mortality rate ( p < 0.001 ) , preventing death in most cases .
RESULTS	Parasitaemia loads decreased by 88.7 % ( 61.8-100 % ) within 24 hours after administration .
RESULTS	Symptoms of cerebral malaria were prevented or reversed .
RESULTS	Dihydroartemisinin was detected in mice blood and brain within 15 minutes of intranasal administration .
RESULTS	No direct nasal or brain toxicity was detected .
CONCLUSIONS	Intranasal delivery is an efficient route to timely and efficiently administer artesunate and therefore may contribute to decreasing malaria-related mortality .

###25167224
BACKGROUND	There is concern about public understanding of overdiagnosis in breast cancer screening , and uncertainty about the likely impact on screening participation .
METHODS	In a population-based survey of 2272 women , we assessed understanding of overdiagnosis and screening intentions before and after exposure to an explanation of overdiagnosis , and one of the three information formats providing an estimate of the rate of overdiagnosis based on the findings of the UK Independent Review .
RESULTS	Subjective and objective comprehension of overdiagnosis was moderate across information formats ( 64 % and 57 % , respectively ) .
RESULTS	Following overdiagnosis information , 7 % of women showed a decrease in screening intention , with a stronger effect among women below screening age ( < 47 years ) , and receiving the estimate of the rate of overdiagnosis in a simple ratio format ( one life saved to three overdiagnoses ) .
CONCLUSIONS	Brief written information on overdiagnosis was incompletely understood , but reduced breast screening intentions in a proportion of women , regardless of comprehension .
CONCLUSIONS	Subjective comprehension was lower among women who had not yet reached screening age but the deterrent effect was higher .

###26077176
OBJECTIVE	Tetrahydrobiopterin ( BH4 ) , a cofactor of nitric oxide synthase , might have a role in the treatment of portal hypertension ( PHT ) as its administration improves endothelial nitric oxide generation and hepatic endothelial dysfunction , and reduces portal pressure in experimental models of cirrhosis .
OBJECTIVE	Sapropterin is an oral synthetic analogue of BH4 recently approved for the treatment of phenylketonuria .
OBJECTIVE	This study evaluated the safety and effects of sapropterin on hepatic and systemic hemodynamics in patients with cirrhosis and PHT .
METHODS	Forty patients with cirrhosis and PHT ( hepatic venous pressure gradient ( HVPG ) 10mmHg ) were randomly allocated to receive sapropterin ( n = 19 ) for 2 weeks ( 5mg/kg/day increased to 10 at day 8 ) or placebo ( n = 21 ) in a double-blind multicenter clinical trial .
METHODS	Randomization was stratified according to concomitant treatment with - adrenergic blockers .
METHODS	We studied at baseline and post-treatment splanchnic ( HVPG and hepatic blood flow ( HBF ) ) and systemic hemodynamics , endothelial dysfunction and oxidative stress markers ( von Willebrand factor and malondialdehyde ) , liver function tests , and safety variables .
RESULTS	HVPG was not modified by either sapropterin ( 16.04.4 vs. 15.84.7 mmHg ) or placebo ( 16.04.6 vs. 15.54.9 mmHg ) .
RESULTS	HBF , systemic hemodynamics , endothelial dysfunction markers , and liver function tests remained unchanged .
RESULTS	Sapropterin was well tolerated ( no patient required dose adjustment or withdrawal ) , and adverse events were mild and similar between groups .
CONCLUSIONS	Sapropterin , an oral synthetic analogue of BH4 , at the used dose did not reduce portal pressure in patients with cirrhosis .
CONCLUSIONS	Sapropterin was safe and no serious adverse effects or deleterious systemic hemodynamic effects were observed .

###25946938
BACKGROUND	Multiple sclerosis ( MS ) is the most common cause of progressive neurological disability .
BACKGROUND	The prevalence of MS is much more common in women than men .
BACKGROUND	The women are exposed to a variety of symptoms including fatigue .
BACKGROUND	Acupressure is a noninvasive procedure that can be used to control symptoms including fatigue .
BACKGROUND	The aim of the study was to evaluate the effect of acupressure on fatigue in women with multiple sclerosis .
METHODS	A randomized clinical trial was conducted on 100 women with MS at Tehran MS Association .
METHODS	The subjects were equally allocated to experimental group and a placebo group ( 50 women per group ) by blocking randomization method .
METHODS	The experimental group were received acupressure , at the true points ( ST36 , SP6 , LI4 ) and the placebo group , were received touching at the same points .
METHODS	Fatigue was measured by a Fatigue Severity Scale ( FSS ) in the groups at immediately prior to , two and four weeks after the beginning of the intervention .
METHODS	The data was analyzed using descriptive and inferential statistics by SPSS version 17 .
RESULTS	The findings indicated no differences in demographic characteristics and the severity of fatigue at the baseline in two groups ( p = 0.54 ) .
RESULTS	But there were significant reductions of the mean score of fatigue in the experimental group compared to the placebo group immediately , two and four weeks after the intervention respectively ( p = 0.03 , p ?
RESULTS	0/001 , p = 0.04 ) .
CONCLUSIONS	According to the findings , the study provided an alternative method for health care providers including nurses to train acupressure to the clients with MS to managing their fatigue .

###25000437
BACKGROUND	Intra-articular injection of local anaesthetics is a technique commonly used to enhance postoperative analgesia following arthroscopic surgery .
BACKGROUND	However , the potential for cartilage damage due to toxicity of intra-articular local anaesthetics is a concern .
BACKGROUND	Most studies indicate that the toxic effect is drug and time dependent .
OBJECTIVE	The objective of this study is to compare the in-vitro chondrotoxic effect of levobupivacaine on human cartilage with saline and bupivacaine .
METHODS	An experimental study .
METHODS	University hospital .
METHODS	Adult patients undergoing knee surgery .
METHODS	Human articular cartilage was harvested and removed from five patients during knee replacement surgery .
METHODS	Chondrocytes were cultured and divided into three groups exposed to bupivacaine 0.5 % , levobupivacaine 0.5 % or physiological saline for 15 , 30 or 60min .
METHODS	Viability of human cartilage cells after contact with the different study drugs at different durations of exposure using two techniques : live/dead cell viability flow cytometry analysis and trypan blue exclusion assay .
RESULTS	At 1h of exposure , chondrocyte mortality in cartilage explants was significantly greater after treatment with levobupivacaine or bupivacaine than with saline ( 25.9 % 14.1 , 20.7 % 10.4 and 9.6 % 5.4 , respectively ) .
RESULTS	No differences between groups were found when exposure to the experimental drug was limited to 15 or 30min .
CONCLUSIONS	In-vitro 0.5 % levobupivacaine is more chondrotoxic than saline in human articular cartilage after 1h of exposure .
CONCLUSIONS	Bupivacaine seems to be less chondrotoxic than levobupivacaine .
CONCLUSIONS	With shorter exposures , no clear chondrotoxic effect was shown .

###24654699
BACKGROUND	To examine the efficacy and safety of combined phaco-trabeculectomy in patients with cataract and controlled , open-angle advanced glaucoma and to identify preoperative predictive factors of postoperative glaucoma course .
METHODS	Departments of Ophthalmology , University of Athens , and General Hospital of Lamia , Greece .
METHODS	Prospective , interventional , parallel , cluster ( units = examinations ) , randomized clinical study .
METHODS	60 patients with visually significant cataract , visual field Mean Deviation ( MD ) worse than -15.0 dB , and preoperative intraocular pressure ( IOP ) , controlled ( consistently below 22 mmHg ) on topical medications and with no previous ocular surgery , were randomly allocated ( 1:1 ) to phacoemulsification alone or phaco-trabeculectomy group .
METHODS	Intention-to-treat analysis was performed to compare the postoperative outcome and adjusted multivariate longitudinal linear regression analysis was performed to identify predictive factors of the main outcome measures , with postoperative visual field MD change up to two years postoperatively .
METHODS	Participant recruiters and data collectors were masked to group assignment .
RESULTS	31 and 29 patients were randomized to phacoemulsification alone and phaco-trabeculectomy groups , respectively .
RESULTS	Patients assigned to the phaco-trabeculectomy group experienced a 1.7 mmHg [ 95 % CI : -3.1 to -0.23 ] reduction in IOP , a 1.4 dB [ 95 % CI : -0.17 to 2.96 ] improvement in visual fields MD , a 0.6 [ 95 % CI : -1.2 to -0.05 ] reduction in the number of glaucoma medications needed postoperatively , while the visual acuity improvement was similar between the two groups .
RESULTS	Best predictors for visual field MD : degree of nuclear sclerosis , relative afferent pupilary defect ( RAPD ) , preoperative MD deviation from -19.0 dB and preoperative cup-disc ratio deviation from 0.9 .
RESULTS	The phacoemulsification group experienced more IOP spikes ( > 25 mmHg ) with Odds Ratio ( OR ) of 0.34 [ 95 % CI : 0.11-1 .02 ] .
RESULTS	No patient lost light perception .
CONCLUSIONS	Phaco-trabeculectomy in advanced , controlled , open-angle glaucoma patients with cataract results in better postoperative visual field MD with no major adverse events .

###24595942
OBJECTIVE	To evaluate the effects of orally administered dehydrated garlic powder on cytokine excretion in the urinary tract .
METHODS	A total of 60 healthy volunteers , randomized into 3 groups , were given a single oral dose of 1 g or 3 g of dehydrated garlic powder or placebo .
METHODS	Urine samples were obtained 6.0 and 24.0 h after garlic intake and assayed for interleukin-8 ( IL-8 ) , interleukin - 12 ( IL-12 ) , tumor necrosis factor-alpha ( TNF - ) , diallyl disulfide ( DADS ) and diallyl sulfide ( DAS ) .
RESULTS	Significant increases in IL-12 levels over baseline were noted in urine samples obtained after oral intake of 1 g and 3 g of garlic powder ( P < .001 ) .
RESULTS	In the 1 g and 3 g garlic powder treatment groups , time-dependent variations in IL-12 levels over the study period were significantly different from the placebo group ( P < .001 ) .
RESULTS	In both garlic treatment groups , urinary levels of IL-8 and TNF - were not significantly different from baseline and placebo levels ( P > .017 ) .
RESULTS	DADS and DAS were not detected in the urine samples at any time after garlic powder intake .
CONCLUSIONS	Oral intake of doses of garlic traditionally used for daily supplementation increases urinary levels of IL-12 , which is a potent stimulator of T helper cell 1 ( Th-1 ) immune responses .
CONCLUSIONS	This observation encourages further studies investigating the immunostimulatory role of garlic in the urinary tract .

###24854829
BACKGROUND	Greater exposure to an orosensory cue could increase habituation rate .
BACKGROUND	This investigation examined salivary habituation during 10 lemon juice trials providing exposure via olfactory , gustatory , and combined systems .
METHODS	Healthy , normal-weight , unrestrained females ( age = 20.7 2.7 year , body mass index [ BMI ] = 22.2 1.5 kg/m ( 2 ) , 70.0 % white ) were randomly assigned to 1 of 3 conditions : olfactory ( SMELL : n = 8 ) , gustatory ( TASTE : n = 10 ) , or olfactory + gustatory ( SMELL+TASTE : n = 9 ) .
METHODS	All conditions completed 12 , 2-minute , trials ( trials 1-2 : water [ baseline ] ; trials 3-12 : lemon juice ) , in which salivation was measured .
METHODS	In conditions with taste exposure , 0.05 ml of the stimulus was placed on the tongue .
METHODS	In conditions with smell exposure , 4.0 g of the stimulus was held 0.5 in from the nose .
METHODS	Salivation was measured using dental rolls and mean salivation of every two trials was the dependent variable .
RESULTS	A mixed-factor ANCOVA , controlling for baseline differences between the conditions in lemon juice hedonics , found a significant ( p < 0.05 ) interaction of condition x trial .
RESULTS	SMELL+TASTE significantly ( p < 0.05 ) increased salivation from baseline to lemon juice exposure , and decreased salivation by the last two mean trials .
RESULTS	TASTE had a significant ( p < 0.05 ) increase in salivation from baseline to lemon juice , with no decrease .
CONCLUSIONS	Repeated exposure to an orosensory cue by combined olfactory and gustatory systems produced a faster habituation rate than exposure by the gustatory system alone .
CONCLUSIONS	Thus , food cues that combine exposure to the olfactory and gustatory systems may enhance satiation .

###24511715
OBJECTIVE	To study the effectiveness of sublingual misoprostol for cervical ripening before MVA in women aged between 35 and 55 years old .
METHODS	Women aged between 35 and 55 years old who had indications for endometrial sampling were recruited .
METHODS	Exclusion criteria were gross pathology of cervix , pregnancy , allergy to misoprostol , and abnormal coagulopathy .
METHODS	Eighty women who had indication for MVA were then assigned by randomization ( block of four ) .
METHODS	Participants were treated with either sublingual 200 microg of misoprostol ( study group ) or placebo ( controlled group ) for cervical priming at two hours before procedure .
METHODS	The largest diameter of the Hegar 's dilator through internal so without any resistance before MVA was the primary collected data .
METHODS	Secondary data were operating time , immediate pain score , satisfactory score , complications , and side effects .
RESULTS	Mean age of misoprostol and controlled group were 44.8 + / - 5.2 and 45.5 + / - 5.0 years old , respectively .
RESULTS	One third of both groups had previously experienced uterine curettage .
RESULTS	The initial cervical diameter before MVA of individuals receiving misoprostol and controlled group were 6.9 + / - 2.0 and 5.5 + / - 2.4 mm , respectively .
RESULTS	The MVA time in misoprostol group was significantly shorter than controlled group ( 5.1 + / - 1.7 vs. 8.0 + / - 3.9 min , p < 0.001 ) .
RESULTS	The additional analgesia was not different in both groups .
RESULTS	Side effect before MVA were more significantly found in misoprostol group ( p = 0.001 ) .
RESULTS	Lower post MVA pain and satisfactory score were better reported in misoprostol group than placebo 's ( p < 0.001 ) .
CONCLUSIONS	Two hundred micrograms of sublingual misoprostol administration prior to MVA gave significantly effective result of cervical priming .
CONCLUSIONS	Satisfactory and pain scores were more favorable in misoprostol group with manageable side effects .

###25223181
OBJECTIVE	To observe the effect of Qingfei Peiyuan Micro-pill ( QPM ) on HIV/AIDS patients with pulmonary infection of phlegm heat obstructing lung syndrome ( PHOLS ) .
METHODS	Totally 141 HIV/AIDS patients with pulmonary infection of PHOLS were randomly assigned to the treatment group ( 94 cases ) and the control group ( 47cases ) .
METHODS	On the basis of Western medicine , patients in the treatment group took QPM .
METHODS	The therapeutic course for all was 28 days .
METHODS	The improvement of symptoms and signs was observed .
METHODS	The body temperature ( BT ) , chest X ray , and white blood cells ( WBCs ) were detected .
RESULTS	The Chinese medical syndrome score was lower in the treatment group than in the control group at the 7th , 21st , and 28th day of treatment , showing statistical difference ( P < 0.05 ) .
RESULTS	The efficacy was better in the treatment group than in the control group at the 7th , 21st , and 28th day of treatment , showing statistical difference ( P < 0.05 ) .
RESULTS	The BT was lower in the treatment group than in the control group on the 7th day .
RESULTS	There was no statistical difference in the patient number with normal WBCs on the 7th day ( P > 0.05 ) .
RESULTS	But there was statistical difference in the patient number with normal WBCs on the 14th , 21st , and 28th day of treatment ( P < 0.05 ) .
RESULTS	There was no statistical difference in the patient number with normal chest X ray on the 7th and 28th day of treatment ( P > 0.05 ) .
RESULTS	But there was statistical difference in the patient number with normal chest X ray on the 14th and 21 st day of treatment ( P < 0.05 ) .
CONCLUSIONS	QPM had certain complementary effect on HIV/AIDS patients with pulmonary infection of PHOLS .

###25360528
OBJECTIVE	Bone allografts used for interbody spinal fusion are often preserved through either freeze drying or lowtemperature freezing , each having disadvantages related to graft preparation time and material properties .
OBJECTIVE	In response , a glycerol preservation treatment has been developed to maintain the biomechanical properties of allografts at ambient temperatures , requiring no thawing or rehydration and minimal rinsing prior to implantation .
OBJECTIVE	The authors conducted a prospective randomized study to compare the clinical results of glycerol-preserved Cloward dowels and those of freezedried Cloward dowels in anterior cervical discectomy and fusion .
OBJECTIVE	The primary outcome measures were evidence of fusion and graft subsidence , and the secondary outcome measures included adverse events , pain , and neck disability scores .
METHODS	Of 106 patients , 53 ( 113 levels of surgery ) were randomly assigned to the glycerol-preserved graft group and 53 ( 114 levels of surgery ) to the freeze-dried graft group .
METHODS	Subsidence was assessed at 3 and 6 months after implantation .
METHODS	Evidence of fusion was evaluated radiographically at 6 months postimplantation .
METHODS	Subsidence was quantitatively assessed based on physical measurements obtained from radiographs by using calibrated comparators , whereas fusion was also evaluated visually .
METHODS	Surgeons were blinded to treatment type during visual and physical assessments of the patients and the radiographs .
RESULTS	No one in either group had evidence of complete nonunion according to radiographic evaluation at the 6-month follow-up .
RESULTS	Average subsidence for all graft-treated levels was 2.11 mm for the glycerol-preserved group and 2.73 mm for the freeze-dried group at the 3-month follow-up and 2.13 and 2.83 mm at the 6-month follow-up , respectively .
RESULTS	The 2 treatment groups were statistically equivalent ( p = 0.2127 and 0.1705 for the 3 - and 6-month follow-up , respectively ) .
RESULTS	No differences were noted between the graft types in terms of adverse event incidence or severity .
CONCLUSIONS	Glycerol-preserved bone allografts exhibit fusion results and subsidence values similar to those of their freeze-dried counterparts , potentially more favorable biomechanical properties , and significantly shorter preparation times .

###24300266
OBJECTIVE	To compare the variations of cardiovascular responses and vascular angiotensin II ( AngII ) in hypertensive patients during tracheal intubation with intubating laryngeal mask airway ( ILMA ) versus direct laryngoscope ( DLS ) .
METHODS	A total of 120 hypertensive patients undergoing abdominal surgery were randomly divided into 2 groups , i.e.intubating laryngeal mask airway ( Group I ) and direct laryngoscope ( Group D ) .
METHODS	Variations of invasive arterial blood pressure and angiotensin II were compared between two groups before and after intubation .
RESULTS	The variations of cardiovascular responses and vascular angiotensin II ( AngII ) during tracheal intubation used of ILMA ( T4 ) and DLS ( T4 ) in an instant , tracheal intubation were immediately accomplished in two groups ( T5 ) .
RESULTS	The variations of group I were significantly lower than those of group D ( P < 0.05 ) .
RESULTS	And statistical significance existed between two groups .
CONCLUSIONS	Tracheal intubation with intubating laryngeal mask airway ( ILMA ) can significantly reduce violent cardiovascular reactions and avoid cardiovascular accidents .

###25291116
BACKGROUND	Bacterial vaginosis ( BV ) is the most common reason for abnormal vaginal discharge in reproductive-age women and one of its most important causative agents is the gram-variable bacterium Gardnerella vaginalis .
BACKGROUND	BV is not accompanied by significant local inflammation , whereas the `` fishy odor '' test is always positive .
BACKGROUND	In contrast , aerobic vaginitis ( AV ) is predominantly associated with Escherichia coli , but Streptococcus agalactiae and Staphylococcus aureus are also involved .
BACKGROUND	Standard treatment of BV consists of oral or intravaginal antibiotics , although these are unable to spontaneously restore normal flora characterized by a high concentration of lactobacilli .
BACKGROUND	The main limitation is the inability to offer a long-term defensive barrier , thus facilitating relapses and recurrences .
BACKGROUND	This study was undertaken firstly to assess the ability of selected lactobacilli to in vitro antagonize G. vaginalis to determine an association with a strain able to inhibit E. coli , thus identifying a possible use in AV .
BACKGROUND	The second step of the study was to conduct a human pilot trial in women affected by BV using an association of the most promising and active bacteria .
METHODS	For this purpose , neutralized supernatants of individual lactobacilli were tested at percentages ranging from 0.5 % to 4 % to determine their ability to hinder the growth of G. vaginalis American Type Culture Collection 10231 .
METHODS	The bacterium that was able to exert the strongest inhibition was subsequently tested with Lactobacillus plantarum LP01 in a human intervention , placebo-controlled , pilot trial involving 34 female subjects ( aged between 18 and 50 , mean 34.78.9 , no menopausal women ) diagnosed with BV .
METHODS	The 2 microorganisms Lactobacillus fermentum LF15 ( DSM 26955 ) and L. plantarum LP01 ( LMG P-21021 ) were delivered to the vagina by means of slow-release vaginal tablets , also containing 50 mg of tara gum .
METHODS	The amount of each strain was 400 million live cells per dose .
METHODS	The women were instructed to apply a vaginal tablet once a day for 7 consecutive nights , followed by 1 tablet every 3 nights for a further 3-week application ( acute phase ) and , finally , 1 tablet per week to maintain a long-term vaginal colonization against possible recurrences .
METHODS	A clinical examination was performed and the Nugent score was quantified for each patient at enrollment ( d0 ) , after 28 days ( d28 ) , and at the end of the second month of relapse prevention ( d56 ) .
METHODS	A statistical comparison was made between d28 , or d56 , and d0 , and between d56 and d28 to quantify the efficacy against possible recurrences .
RESULTS	L. fermentum LF15 showed the strongest in vitro inhibitory activity towards G. vaginalis American Type Culture Collection ( ATCC ) 10231 after both 24 and 48 hours .
RESULTS	In the human trial , the 2 lactobacilli selected , namely L. fermentum LF15 and L. plantarum LP01 , significantly reduced the Nugent score below the threshold of 7 after 28 days in 22 patients of 24 in the active group ( 91.7 % , P < 0.001 ) .
RESULTS	Eight women ( 33.3 % ) recorded a Nugent score between 4 and 6 , evidence of an intermediate situation , whereas the remaining 14 ( 58.3 % ) showed a score < 4 , therefore suggesting the restoration of physiological vaginal microbiota .
RESULTS	At the end of the second month , only 4 women registered a Nugent score > 7 , definable as BV ( 16.7 % , P = 0.065 compared with d28 ) .
RESULTS	In the placebo group , no significant differences were recorded at any time .
CONCLUSIONS	BV , also known as vaginal bacteriosis is the most common cause of vaginal infection in women of childbearing age .
CONCLUSIONS	Furthermore , BV is often asymptomatic as about 50 % of women with this condition have no symptoms at all and the prevalence rate in apparently healthy women is around 10 % .
CONCLUSIONS	This study suggests the ability of the 2 strains L. fermentum LF15 and L. plantarum LP01 to counteract acute Gardnerella infections effectively and significantly improve the related uncomfortable symptoms in a very high percentage of women .
CONCLUSIONS	This could be partially attributed to the presence of tara gum , which is able to create a mechanical barrier against Gardnerella on the surface of vaginal mucosa as a primary mechanism .
CONCLUSIONS	Furthermore , long-term physiological protection seems to be established , thanks to the integration of the 2 lactobacilli into the vaginal microbiota and to their adhesion to the epithelial cells of the mucosa .
CONCLUSIONS	In the light of the additional in vitro inhibitory activity against E. coli , their prospective use in AV could also prove interesting .

###25819691
BACKGROUND	The mainstay of treatment for Gaucher 's disease type 1 is alternate-week infusion of enzyme replacement therapy ( ERT ) .
BACKGROUND	We investigated whether patients stable on such treatment would remain so after switching to oral eliglustat , a selective inhibitor of glucosylceramide synthase .
METHODS	In this phase 3 , randomised , multinational , open-label , non-inferiority trial , we enrolled adults ( aged 18 years ) who had received ERT for 3 years or more for Gaucher 's disease .
METHODS	Patients were randomly allocated 2:1 at 39 clinics ( stratified by ERT dose ; block sizes of four ; computer-generated centrally ) to receive either oral eliglustat or imiglucerase infusions for 12 months .
METHODS	Participants and investigators were aware of treatment assignment , but the central reader who assessed organ volumes was masked .
METHODS	The composite primary efficacy endpoint was percentage of patients whose haematological variables and organ volumes remained stable for 12 months ( ie , haemoglobin decrease not more than 15 g/L , platelet count decrease not more than 25 % , spleen volume increase not more than 25 % , and liver volume increase not more than 20 % , in multiples of normal from baseline ) .
METHODS	The non-inferiority margin was 25 % for eliglustat relative to imiglucerase , assessed in all patients who completed 12 months of treatment .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00943111 , and EudraCT , number 2008-005223-28 .
RESULTS	Between Sept 15 , 2009 , and Nov 9 , 2011 , we randomly allocated 106 ( 66 % ) patients to eliglustat and 54 ( 34 % ) to imiglucerase .
RESULTS	In the per-protocol population , 84 ( 85 % ) of 99 patients who completed eliglustat treatment and 44 ( 94 % ) of 47 patients who completed imiglucerase treatment met the composite primary endpoint ( between-group difference -88 % ; 95 % CI -176 to 42 ) .
RESULTS	The lower bound of the 95 % CI of -176 % was within the prespecified threshold for non-inferiority .
RESULTS	Dropouts occurred due to palpitations ( one patient on eliglustat ) , myocardial infarction ( one patient on eliglustat ) , and psychotic disorder ( one patient on imiglucerase ) .
RESULTS	No deaths occurred .
RESULTS	97 ( 92 % ) of 106 patients in the eliglustat group had treatment-emergent adverse events , as did 42 ( 79 % ) of 53 in the imiglucerase group ( mostly mild or moderate in severity ) .
CONCLUSIONS	Oral eliglustat maintained haematological and organ volume stability in adults with Gaucher 's disease type 1 already controlled by intravenous ERT and could be a useful therapeutic option .
BACKGROUND	Genzyme , a Sanofi company .

###24914242
OBJECTIVE	To investigate the association of the rate of weight gain ( Ratemax_wt ) between the age of 20 years and the age of maximum lifetime weight gain with indicators of subclinical coronary artery disease ( CAD ) at the time of diagnosis of type 2 diabetes ( T2D ) .
METHODS	We studied 1,724 consecutive Korean subjects aged 30 years with recently diagnosed ( within 3 months ) T2D and one or more cardiovascular risk factors to investigate the association of Ratemax_wt with subclinical CAD .
METHODS	We used 64-slice cardiac computed tomography angiography to evaluate the degree of coronary artery stenosis , multivessel involvement , plaque characteristics , and coronary artery calcium score ( CACS ) .
METHODS	Body weight at age 20 years ( Wt20y ) was obtained from participant records .
METHODS	Participants recalled their maximum weight ( Wtmax ) before T2D diagnosis and age at maximum weight ( Agemax_wt ) .
METHODS	The Ratemax_wt was calculated as ( Wtmax - Wt20y ) / ( Agemax_wt - 20 years ) .
RESULTS	The prevalence of coronary artery stenosis ( 50 % ) , multivessel involvement ( two or more vessels ) , plaque characteristics , and CACS 100 were 11.4 % , 6.6 % , 19.7 % , and 12.8 % , respectively .
RESULTS	Mean Wt20y and Wtmax were 60.1 10.5 and 73.0 11.5 kg , respectively .
RESULTS	Mean Agemax_wt was 41.3 10.7 years , and Ratemax_wt was 0.59 0.56 kg/year .
RESULTS	After adjusting for cardiovascular risk factors , including current BMI , the highest quarter of prior weight gain was significantly associated with coronary artery stenosis , multivessel involvement , and plaque characteristics , particularly mixed and noncalcified plaque .
CONCLUSIONS	The findings suggest that a greater rate of prior weight gain may accelerate the development of subclinical vascular complications in patients with newly diagnosed T2D .

###25248448
BACKGROUND	Studies suggest that the observation of others ' actions leads to enhanced motor skill learning .
OBJECTIVE	We examined whether others ' or self-action observation is effective for standing balance learning .
OBJECTIVE	In addition , we examined cortical activation during action observation using functional near-infrared spectroscopy .
METHODS	Thirty-nine healthy young subjects were assigned randomly to the Control , Other-Observation ( O-O ) , and Self-Observation ( S-O ) groups .
METHODS	The subjects learned to stand on a tilting platform while maintaining a horizontal position .
METHODS	The Control group alternated each trial with a rest period .
METHODS	The O-O and S-O groups were provided with information related to their performance during the rest period : the O-O group observed another person , while the S-O group observed their previous performance .
METHODS	Cortical activation was assessed by changes of hemoglobin oxygenation ( oxyHb ) .
RESULTS	A 2-way analysis of variance with repeated measures on balance performance revealed a significant difference in post-training ( p < 0.05 ) and retention ( p < 0.01 ) only in the S-O group .
RESULTS	And an increase of oxyHb levels at post-training in the S-O group was observed in the supplementary motor area .
CONCLUSIONS	Self-action observation improved standing balance and brain activity during training and at 24 h after training .

###24642648
OBJECTIVE	To verify the eventual efficacy of lactoferrin ( LF ) , an iron-binding glycoprotein , to decrease the amniotic concentration of interleukin-6 ( IL-6 ) .
METHODS	We prospectively enrolled 60 Caucasian patients at the 16th week of their singleton physiological gestation .
METHODS	A vaginal compound containing 300 mg of LF was administered randomly 4 or 12 h prior to amniocentesis , as to obtain 3 groups : A , 20 untreated patients ; B , 20 treated 4 h before amniocentesis ; C , 20 treated 12 h before amniocentesis .
RESULTS	A normal karyotype was registered in all cases .
RESULTS	The comparison of the distribution of IL-6 among the 3 groups showed a highly significant difference ( p = 0.001 ) .
RESULTS	The difference between mean values of group B and both groups C and A was shown to be highly significant ( p = 0.006 and p = 0.03 , respectively ) .
RESULTS	In contrast , there was no significant difference between mean values of groups A and C.
CONCLUSIONS	Vaginal LF administration decreases amniotic IL-6 concentration .
CONCLUSIONS	We therefore suggest that the glycoprotein may exert a protective role against ominous pregnancy complications linked to an increased level of the cytokine , such as abortion secondary to amniocentesis .

###25044383
BACKGROUND	Anemia is a frequent condition in patients with chronic kidney disease due to a reduction in the production of erythropoietin .
BACKGROUND	Patients with inflammation respond less well to treatment with erythropoietin , possibly because the increased production of hepcidin reduces the availability of iron for hematopoiesis .
BACKGROUND	Some studies suggest that pentoxifylline has anti-inflammatory properties and could be used as adjuvant therapy in the treatment of anemia .
OBJECTIVE	The aim of this study was to analyze the effect of pentoxifylline on serum hepcidin in chronic hemodialysis patients with inflammation .
METHODS	71 adult patients on hemodialysis with C-reactive protein ( CRP ) 0.5 mg/dl in screening tests ; patients were randomized to the treatment group ( oral pentoxifylline 400 mg/thrice-weekly ) or the control group for 3 months follow-up .
RESULTS	During the study , a decrease in hemoglobin , transferrin saturation , and hepcidin was observed in both groups .
RESULTS	However , these reductions were related to the time and not to the drug .
RESULTS	There was no difference in the concentrations of CRP , ferritin , and albumin over time in either group .
CONCLUSIONS	The use of this amount of pentoxifylline did not modify the serum levels of hepcidin in this population .

###24938529
OBJECTIVE	To investigate the quality of reporting for randomised controlled trials of acupuncture for neurological disorders conducted in China before and after the implementation of the Consolidated Standards of Reporting Trials ( CONSORT ) and Standards for Reporting Interventions in Controlled Trials of Acupuncture ( STRICTA ) guidelines .
METHODS	The quality of reporting for included papers was assessed against a subset of criteria adapted from CONSORT and STRICTA .
METHODS	CONSORT and STRICTA were developed in 1996 and 2001 , respectively .
METHODS	Thus , for the date of publication we selected 2-year periods , at 5-yearly intervals : 1994-1995 ; 1999-2000 ; 2004-2005 and 2009-2010 .
METHODS	These selections cover the periods before the publication dates of both guidelines ( 1996 , 2001 ) and at least 3years afterwards , and provide reasonably up-to-date data .
METHODS	We calculated the total score for each guideline and compared reported differences during different date ranges .
RESULTS	For CONSORT items ( maximum score 8 ) , there was evidence of a slight improvement in reporting between 1994-1995 and 1999-2000 combined ( 2.50.6 ) and 2004-2005 and 2009-2010 combined ( 3.00.9 ) ( difference 0.5 , 95 % CI 0.2 to 0.8 ) .
RESULTS	For STRICTA items ( maximum score 17 ) , there was evidence of a slight improvement in reporting between 1994-1995 and 1999-2000 combined ( 8.91.8 ) and 2004-2005 and 2009-2010 combined ( 10.31.6 ) ( difference 1.4 , 95 % CI 0.9 to 1.9 ) .
CONCLUSIONS	The quality of reporting for studies of acupuncture for neurological disorders has generally improved since the implementation of STRICTA and CONSORT guidelines .

###25444751
BACKGROUND	ADAMTS 13 , sP-Selectin and HSP27 have been investigated as potential prognostic markers in patients with hemorrhagic shock .
METHODS	This study was part of a double-blind , randomized , parallel-group , controlled trial and included seventeen trauma patients presented to ED with severe hemorrhagic .
METHODS	The sera for testing were collected from these patients at the time of admission .
METHODS	Investigators and laboratory personnel performing testing were blinded to the patients ' identity and clinical course .
RESULTS	The prognostic value of ADAMTS13 , sP-Selectin , and HSP27 was compared to prognostic value of systolic blood pressure ( SBP ) , base deficit estimation ( BD ) , heart rate ( HR ) , shock index ( SI ) and tissue oxygen saturation ( StO2 ) by constructing the receiver operation characteristics ( ROC ) .
RESULTS	The area under the curve ( AUC ) of the ROC for HSP27 ( 0.92 ) was greater than for SBP ( 0.45 ) , BD ( 0.89 ) , HR ( 0.61 ) , SI ( 0.45 ) and StO2 ( 0.46 ) .
RESULTS	AUC for sP-Selectin ( 0.86 ) and for ADAMTS13 antigen ( 0.74 ) were comparable with BD one , but greater than for the rest of currently used tests .
CONCLUSIONS	Serum concentrations of ADAMTS13 , HSP27 and sP-Selectin measured during the admission , appear to be comparable to or better than SBP , BD , SI , HR and StO2 in predicting MODS and death after hemorrhage from trauma .
CONCLUSIONS	These potential new markers deserve further investigation .

###25673013
BACKGROUND	Phone-based tobacco cessation program effectiveness has been established and randomized controlled trials have provided some support for Web-based services .
BACKGROUND	Relatively little is known about who selects different treatment modalities and how they engage with treatments in a real-world setting .
OBJECTIVE	This paper describes the characteristics , Web utilization patterns , and return rates of tobacco users who self-selected into a Web-based ( Web-Only ) versus integrated phone/Web ( Phone/Web ) cessation program .
METHODS	We examined the demographics , baseline tobacco use , Web utilization patterns , and return rates of 141,429 adult tobacco users who self-selected into a Web-Only or integrated Phone/Web cessation program through 1 of 10 state quitlines from August 2012 through July 2013 .
METHODS	For each state , registrants were only included from the timeframe in which both programs were offered to all enrollees .
METHODS	Utilization data were limited to site interactions occurring within 6 months after registration .
RESULTS	Most participants selected the Phone/Web program ( 113,019 / 141,429 , 79.91 % ) .
RESULTS	After enrollment in Web services , Web-Only were more likely to log in compared to Phone/Web ( 21,832 / 28,410 , 76.85 % vs 23,920 / 56,892 , 42.04 % ; P < .001 ) , but less likely to return after their initial log-in ( 8766/21 ,832 , 40.15 % vs 13,966 / 23,920 , 58.39 % ; P < .001 ) .
RESULTS	In bivariate and multivariable analyses , those who chose Web-Only were younger , healthier , more highly educated , more likely to be uninsured or commercially insured , more likely to be white non-Hispanic and less likely to be black non-Hispanic , less likely to be highly nicotine-addicted , and more likely to have started their program enrollment online ( all P < .001 ) .
RESULTS	Among both program populations , participants were more likely to return to Web services if they were women , older , more highly educated , or were sent nicotine replacement therapy ( NRT ) through their quitline ( all P < .001 ) .
RESULTS	Phone/Web were also more likely to return if they had completed a coaching call , identified as white non-Hispanic or `` other '' race , or were commercially insured ( all P < .001 ) .
RESULTS	Web-Only were less likely to return if they started their enrollment online versus via phone .
RESULTS	The interactive Tobacco Tracker , Cost Savings Calculator , and Quitting Plan were the most widely used features overall .
RESULTS	Web-Only were more likely than Phone/Web to use most key features ( all P < .001 ) , most notably the 5 Quitting Plan behaviors .
RESULTS	Among quitlines that offered NRT to both Phone/Web and Web-Only , Web-Only were less likely to have received quitline NRT .
CONCLUSIONS	This paper adds to our understanding of who selects different cessation treatment modalities and how they engage with the program in a real-world setting .
CONCLUSIONS	Web-Only were younger , healthier smokers of higher socioeconomic status who interacted more intensely with services in a single session , but were less likely to re-engage or access NRT benefits .
CONCLUSIONS	Further research should examine the efficacy of different engagement techniques and services with different subpopulations of tobacco users .

###24339390
OBJECTIVE	The dose-response effects of exercise training on insulin sensitivity , metabolic risk , and quality of life were examined .
METHODS	Sixty-one healthy , sedentary ( VOmax : 35 5 ml/kg/min ) , moderately overweight ( BMI : 27.9 1.8 ) , young ( age : 29 6 years ) men were randomized to sedentary living ( sedentary control group ; n = 18 ) , moderate ( moderate dose training group [ MOD ] : 300 kcal/day , n = 21 ) , or high ( high dose training group [ HIGH ] : 600 kcal/day , n = 22 ) dose physical exercise for 11 weeks .
RESULTS	The return rate for post-intervention testing was 82-94 % across groups .
RESULTS	Weekly exercise amounted to 2,004 24 and 3,774 68 kcal , respectively , in MOD and HIGH .
RESULTS	Cardiorespiratory fitness increased ( P < 0.001 ) 18 3 % in MOD and 17 3 % in HIGH , and fat percentage decreased ( P < 0.001 ) similarly in both exercise groups ( MOD : 32 1 to 29 1 % ; HIGH : 30 1 to 27 1 % ) .
RESULTS	Peripheral insulin sensitivity increased ( P < 0.01 ) ( MOD : 28 7 % ; HIGH : 36 8 % ) and the homeostasis model assessment of insulin resistance decreased ( P < 0.05 ) ( MOD : -17 7 % ; HIGH : -18 10 % ) .
RESULTS	The number of subjects meeting the criteria of the metabolic syndrome decreased by 78 % in MOD ( P < 0.01 ) and by 80 % in HIGH ( P < 0.05 ) .
RESULTS	General health assessed by questionnaire increased similarly in MOD ( P < 0.05 ) and HIGH ( P < 0.01 ) .
CONCLUSIONS	Only minor additional health benefits were found when exercising 3,800 as opposed to 2,000 kcal/week in young moderately overweight men .
CONCLUSIONS	This finding may have important public health implications .

###25488056
BACKGROUND	We aimed to evaluate clinical symptoms in subjects with irritable bowel syndrome receiving Saccharomyces cerevisiae in a randomized double-blind placebo-controlled clinical trial .
METHODS	Overall , 179 adults with irritable bowel syndrome ( Rome III criteria ) were randomized to receive once daily 500 mg of Saccharomyces cerevisiae , delivered by one capsule ( n = 86 , F : 84 % , age : 42.5 12.5 ) , or placebo ( n = 93 , F : 88 % , age : 45.4 14 ) for 8 weeks followed by a 3-week washout period .
METHODS	After a 2-week run-in period , cardinal symptoms ( abdominal pain/discomfort , bloating/distension , bowel movement difficulty ) and changes in stool frequency and consistency were recorded daily and assessed each week .
METHODS	A safety assessment was carried out throughout the study .
RESULTS	The proportion of responders , defined by an improvement of abdominal pain/discomfort , was significantly higher ( p = 0.04 ) in the treated group than the placebo group ( 63 % vs 47 % , OR = 1.88 , 95 % , CI : 0.99-3 .57 ) in the last 4 weeks of treatment .
RESULTS	A non-significant trend of improvement was observed with Saccharomyces cerevisiae for the other symptoms .
RESULTS	Saccharomyces cerevisiae was well tolerated and did not affect stool frequency and consistency .
CONCLUSIONS	Saccharomyces cerevisiae is well tolerated and reduces abdominal pain/discomfort scores without stool modification .
CONCLUSIONS	Thus , Saccharomyces cerevisiae may be a new promising candidate for improving abdominal pain in subjects with irritable bowel syndrome .

###25142619
OBJECTIVE	This study provides data on the psychometric properties of a newly developed measure of treatment fidelity in Family-Based Treatment ( FBT ) for adolescent anorexia nervosa ( AN ) .
OBJECTIVE	The Family Therapy Fidelity and Adherence Check ( FBT-FACT ) was created to evaluate therapist adherence and competency on the core interventions in FBT .
METHODS	Participants were 45 adolescents and their families sampled from three randomized clinical trials evaluating treatment for AN .
METHODS	Trained fidelity raters evaluated 19 therapists across 90 early session recordings using the FBT-FACT .
METHODS	They also rated an additional 15 session 1 recordings of an alternate form of family therapy-Systemic Family Therapy for the purpose of evaluating discriminant validity of the FBT-FACT .
METHODS	The process of development and the psychometric properties of the FBT-FACT are presented .
RESULTS	Overall fidelity ratings for each session demonstrated moderate to strong inter-rater agreement .
RESULTS	Internal consistency of the measure was strong for sessions 1 and 2 and poor for session 3 .
RESULTS	Principal components analysis suggests sessions 1 and 2 are distinct interventions .
CONCLUSIONS	The FBT-FACT demonstrates good reliability and validity as a measure of treatment fidelity in the early phase of FBT .

###24746649
OBJECTIVE	This study sought to determine the efficacy of low rate fluoroscopy at 7.5 frames/s ( FPS ) versus conventional 15 FPS for reduction of operator and patient radiation dose during diagnostic coronary angiography ( DCA ) and percutaneous coronary intervention ( PCI ) via the transradial approach ( TRA ) .
BACKGROUND	TRA for cardiac catheterization is potentially associated with increased radiation exposure .
BACKGROUND	Low rate fluoroscopy has the potential to reduce radiation exposure .
METHODS	Patients undergoing TRA diagnostic angiography ad-hoc PCI were randomized to fluoroscopy at 7.5 FPS versus 15 FPS prior to the procedure .
METHODS	Both 7.5 and 15 FPS fluoroscopy protocols were configured with a fixed dose per pulse of 40 nGy .
METHODS	Primary endpoints were operator radiation dose ( measured with dosimeter attached to the left side of the thyroid shield in Sievert [ Sv ] ) , patient radiation dose ( expressed as dose-area product in Gycm ( 2 ) ) , and fluoroscopy time .
RESULTS	From October 1 , 2012 to August 30 , 2013 , from a total of 363 patients , 184 underwent DCA and 179 underwent PCI .
RESULTS	Overall , fluoroscopy at 7.5 FPS compared with 15 FPS was associated with a significant reduction in operator dose ( 30 % relative reduction [ RR ] , p < 0.0001 ) ; and in patient 's dose-area product ( 19 % RR ; p = 0.022 ) .
RESULTS	When stratified by procedure type , 7.5 FPS compared with 15 FPS was associated with significant reduction in operator dose during both DCA ( 40 % RR ; p < 0.0001 ) and PCI ( 28 % RR ; p = 0.0011 ) .
RESULTS	Fluoroscopy at 7.5 FPS , compared with 15 FPS , was also associated with substantial reduction in patients ' dose-area product during DCA ( 26 % RR ; p = 0.0018 ) and during PCI ( 19 % RR ; p = 0.13 ) .
RESULTS	Fluoroscopy time was similar in 7.5 FPS and 15 FPS groups for DCA ( 3.4 2.0 min vs. 4.0 4.7 min ; p = 0.42 ) and PCI ( 11.9 8.4 min vs. 13.3 9.7 min ; p = 0.57 ) , respectively .
CONCLUSIONS	Fluoroscopy at 7.5 FPS , compared with 15 FPS , is a simple and effective method in reducing operator and patient radiation dose during TRA DCA and PCI .

###25410653
OBJECTIVE	The protective effect of beta-blockers , ACE inhibitors , and ARBs on anthracycline cardiotoxicity has already been demonstrated , but the effect of aldosterone antagonism , which inhibits the last step of the renin-angiotensin-aldosterone system ( RAAS ) , was questioned .
OBJECTIVE	This study sought to investigate whether spironolactone protects the heart against anthracycline-induced cardiotoxicity .
RESULTS	Eighty-three female patients who were diagnosed with breast cancer were included in the study .
RESULTS	The study population was randomized into spironolactone and control groups .
RESULTS	A dose of 25 mg/day spironolactone was administered to the patients in the spironolactone group .
RESULTS	There were 43 patients ( mean age 5011 years ) in the spironolactone group and 40 patients ( mean age 5110 years ) in the control group .
RESULTS	LVEF decreased from 67.06.1 to 65.77.4 ( P = 0.094 ) in the spironolactone group , and from 67.76.3 to 53.66.8 in the control group ( P < 0.001 ) .
RESULTS	When the general linear model was applied , the interaction of LVEF decrease between groups was significantly lower in the spironolactone group than in the control group ( P < 0.001 ) .
RESULTS	The diastolic functional grade of subjects in the spironolactone group was protected ( P = 0.096 ) , whereas it deteriorated in the control group ( P < 0.001 ) .
CONCLUSIONS	We showed that spironolactone administration used simultaneously with anthracycline group chemotherapeutics protects both myocardial systolic and diastolic functions .
CONCLUSIONS	Spironolactone can be used to protect against anthracycline-induced cardiotoxicity .
BACKGROUND	NCT02053974 .

###25205761
BACKGROUND	Foot pain is highly prevalent in older people and in many cases is associated with inappropriate footwear .
BACKGROUND	This study evaluated the effectiveness of off-the-shelf , extra-depth footwear in reducing foot pain .
METHODS	Community-dwelling older people with disabling foot pain ( 72 men and 48 women aged 65 to 96 years ; mean age 82 [ SD 8 ] ) were randomly allocated to an intervention group ( n = 59 ) or control group ( n = 61 ) .
METHODS	The intervention group was provided with off-the-shelf , extra-depth footwear .
METHODS	Participants in the control group received their footwear at the completion of the study .
METHODS	Both groups continued to receive usual podiatry care for the study period .
METHODS	The primary outcome measure was the Foot Health Status Questionnaire ( FHSQ ) , measured at baseline and 16 weeks .
RESULTS	There was a significant improvement in the FHSQ pain domain ( ANCOVA-adjusted mean difference 11.5 points , 95 % confidence interval 4.2 to 18.8 , p = .002 ) and FHSQ function domain ( 10.0 points , 0.9 to 19.1 , p = .032 ) in the intervention group compared to the control group .
RESULTS	The intervention group also developed fewer keratotic lesions ( mean difference -1.4 , -2.5 to -0.2 , p = .021 ) , were less likely to report the use of co-interventions ( relative risk [ RR ] 0.74 , 0.56 to 0.98 , p = .026 ) and were more likely to report that their foot pain had moderately or markedly improved during the study ( RR = 7.93 , 2.51 to 25.00 , p < .001 ; number needed to treat = 3 , 2 to 5 ) .
CONCLUSIONS	Off-the-shelf , extra-depth footwear significantly reduces foot pain , improves foot function and is associated with the development of fewer keratotic lesions in older people .

###24442678
BACKGROUND	Video-assisted thoracic surgery is gradually replacing conventional open thoracotomy as the method of choice for the treatment of early-stage non-small cell lung cancers , and thoracic surgical trainees must learn and master this technique .
BACKGROUND	Simulation-based training could help trainees overcome the first part of the learning curve , but no virtual-reality simulators for thoracoscopy are commercially available .
BACKGROUND	This study aimed to investigate whether training on a laparoscopic simulator enables trainees to perform a thoracoscopic lobectomy .
METHODS	Twenty-eight surgical residents were randomized to either virtual-reality training on a nephrectomy module or traditional black-box simulator training .
METHODS	After a retention period they performed a thoracoscopic lobectomy on a porcine model and their performance was scored using a previously validated assessment tool .
RESULTS	The groups did not differ in age or gender .
RESULTS	All participants were able to complete the lobectomy .
RESULTS	The performance of the black-box group was significantly faster during the test scenario than the virtual-reality group : 26.6 min ( SD 6.7 min ) versus 32.7 min ( SD 7.5 min ) .
RESULTS	No difference existed between the two groups when comparing bleeding and anatomical and non-anatomical errors .
CONCLUSIONS	Simulation-based training and targeted instructions enabled the trainees to perform a simulated thoracoscopic lobectomy .
CONCLUSIONS	Traditional black-box training was more effective than virtual-reality laparoscopy training .
CONCLUSIONS	Thus , a dedicated simulator for thoracoscopy should be available before establishing systematic virtual-reality training programs for trainees in thoracic surgery .

###24373508
BACKGROUND	A study was conducted to evaluate and compare the effectiveness of two different spot-on topical flea products to control flea infestations on naturally infested dogs and cats in Tampa , FL USA .
METHODS	Thirty-two dogs and 3 cats with natural flea infestations living in 18 homes were treated topically with a 19.53 % w/w spot-on formulation of indoxacarb .
METHODS	Another thirty dogs and 2 cats living in 19 different homes were treated topically with either fipronil ( 9.8 % w/w ) / ( s ) - methoprene ( 8.89 % w/w ) or fipronil ( 9.8 % w/w ) / ( s ) - methoprene ( 11.8 % w/w ) , respectively .
METHODS	All products were applied according to label directions by study investigators on day 0 and again between days 28 and 30 .
METHODS	Flea populations on pets were assessed using visual area counts and premise flea infestations were assessed using intermittent-light flea traps on days 0 , 7 , 14 , 21 , 28-30 , 40-45 , and 54-60 .
RESULTS	A single application of the indoxacarb or fipronil ( s ) - methoprene formulations reduced flea populations on pets by 97.8 % and 85.5 % , respectively within 7 days .
RESULTS	One month ( 28-30 days ) after treatment the indoxacarb and fipronil ( s ) - methoprene formulations reduced on-animal flea burdens by 95.0 % and 49.5 % , respectively .
RESULTS	Following two monthly applications of either the indoxacarb or fipronil ( s ) - methoprene formulations , pet flea burdens were reduced by 99.1 % and 54.8 % , respectively , by days 54-60 .
RESULTS	At the end of the two month study , 77.1 % and 15.6 % of the dogs and cats in the indoxacarb and fipronil ( s ) - methoprene treatment groups , respectively were flea free .
RESULTS	Flea numbers in the indoor-premises were markedly reduced in both treatment groups by days 54-60 , with 97.7 % and 84.6 % reductions in intermittent-light flea trap counts in the indoxacarb and fipronil ( s ) - methoprene treatment groups , respectively .
CONCLUSIONS	This in-home investigation conducted during the summer of 2013 in subtropical Tampa , FL , is the first published U.S field investigation of the indoxacarb topical formulation .
CONCLUSIONS	The indoxacarb formulation was able to effectively control flea populations in heavily flea infested pets and homes .
CONCLUSIONS	The efficacy achieved by the fipronil ( s ) - methoprene formulation against flea infestations on these pets was lower than in previous investigations using the same study design .

###25662413
BACKGROUND	Immune thrombocytopenia is characterised by immune-mediated destruction and suboptimum production of platelets .
BACKGROUND	Despite the absence of supporting evidence , rituximab is frequently used off-label in patients with immune thrombocytopenia .
BACKGROUND	We aimed to assess the efficacy of rituximab as compared with placebo as a splenectomy-sparing treatment in patients who were previously treated with corticosteroids .
METHODS	In this multicentre , randomised , double-masked , placebo-controlled trial , we enrolled corticosteroid unresponsive adult patients ( aged 18 years ) with primary immune thrombocytopenia and a platelet count of less than 3010 ( 9 ) platelets per L. Patients were randomly assigned ( 1:1 ) to four weekly infusions of 375 mg/m ( 2 ) rituximab or placebo .
METHODS	Concurrent treatment with corticosteroids only was allowed during the study .
METHODS	The primary endpoint was rate of treatment failure within 78 weeks -- a composite of splenectomy or meeting criteria for splenectomy after week 12 if splenectomy was not done , assessed in all patients who received at least one dose of study treatment .
METHODS	Secondary endpoints were response rates , relapse rates , and duration of response .
METHODS	Efficacy endpoints were assessed with the Kaplan-Meier method .
METHODS	Safety endpoints were assessed in all patients who received at least one dose .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00344149 .
RESULTS	Between Aug 17 , 2006 , and June 30 , 2011 , we enrolled 112 patients .
RESULTS	32 ( 58 % ) of 55 patients in the rituximab group and 37 ( 69 % ) of 54 patients in the placebo group had treatment failure within 78 weeks ( Kaplan-Meier cumulative incidence 46 % for rituximab vs 52 % for placebo ( hazard ratio [ HR ] 089 , 95 % CI 055-145 ; p = 065 ) .
RESULTS	The cumulative incidence of overall response was 81 % in the rituximab group versus 73 % in the placebo group ( p = 015 ) and complete response was 58 % in the rituximab group versus 50 % in the placebo group ( p = 012 ) .
RESULTS	Of those achieving an overall response , 68 % relapsed in the rituximab group and 78 % relapsed in the placebo group , and of those achieving complete response , 50 % relapsed in the rituximab group and 62 % relapsed in the placebo group .
RESULTS	Time to relapse in the rituximab group was longer in patients who achieved overall response ( 36 vs 7 weeks ; p = 001 ) but not complete response ( 76 vs 49 weeks ; p = 019 ) .
RESULTS	Rates of bleeding were similar in the two groups ( 21 [ 38 % ] in the rituximab group vs 27 [ 50 % ] in the placebo group ; p = 008 ) as were rates of infection ( 22 [ 40 % ] vs 13 [ 24 % ] ; p = 009 ) .
CONCLUSIONS	Despite no reduction in the rate of long-term treatment failure with rituximab , a small benefit can not be ruled out , as suggested by an apparently longer duration of response and numerically higher response rates with rituximab .
BACKGROUND	South-East Regional Health Authority and stfold Hospital , Norway ; Roche , France ; and Roche , Norway .

###25357148
OBJECTIVE	The aim of this study was to analyze the effects of inclined treadmill training on the kinematic characteristics of gait in subjects with hemiparesis .
METHODS	A blind , randomized , controlled study was conducted with 28 subjects divided into two groups : the control group , submitted to partial body weight-support treadmill gait training with no inclination , and the experimental group , which underwent partial body weight-support treadmill training at 10 % of inclination .
METHODS	All volunteers were assessed for functional independence , motor function , balance , and gait before and after the 12 training sessions .
RESULTS	Both groups showed posttraining alterations in balance ( P < 0.001 ) , motor function ( P < 0.001 ) , and functional independence ( P = 0.002 ) .
RESULTS	Intergroup differences in spatiotemporal differences were observed , where only the experimental group showed posttraining alterations in velocity ( P = 0.02 ) and paretic step length ( P = 0.03 ) .
RESULTS	Angular variables showed no significant differences in either group .
CONCLUSIONS	In subjects with hemiparesis , the addition of inclination is a stimulus capable of enhancing the effects of partial body weight-support treadmill gait training .

###24733880
OBJECTIVE	Sexual assault is a major cause of injury , unplanned pregnancy , HIV infection , and mental health problems worldwide .
OBJECTIVE	In parts of sub-Saharan Africa , sexual assault has reached epidemic proportions .
OBJECTIVE	This study evaluated the efficacy of an empowerment and self-defense intervention for adolescent girls to decrease the incidence of sexual assault and harassment in Nairobi 's large informal settlements .
METHODS	A prospective cohort of 1978 adolescents from 4 neighborhoods near Nairobi were taught empowerment , deescalation , and self-defense skills in six 2-hour sessions .
METHODS	The standard-of-care ( SOC ) group ( n = 428 ) received a life skills class .
METHODS	Self-reported , anonymous survey data were collected at baseline and 10.5 months after intervention .
RESULTS	Annual sexual assault rates decreased from 17.9 / 100 person-years at baseline to 11.1 at follow-up ( rate ratio = 1.61 ; 95 % confidence interval [ CI ] , 1.26-1 .86 ; P < .001 ) ; there was no significant change in the SOC group ( 14.3 to 14.0 , rate ratio = 1.02 ; 95 % CI , 0.67-1 .57 , P = .92 ) .
RESULTS	Sexual assault disclosure in the intervention group increased from 56 % to 75 % ( P = .006 ) , compared with a constant incidence of disclosure ( 53 % ) in the SOC group .
RESULTS	The majority ( 52.3 % ) of adolescents in the intervention group reported using skills learned to stop an assault .
CONCLUSIONS	This intervention decreased sexual assault rates among adolescent girls in Kenya .
CONCLUSIONS	The intervention was also associated with an increase in the disclosure of assaults , thereby enabling survivors to seek care and support and possibly leading to the identification and prosecution of perpetrators .
CONCLUSIONS	This model should be adaptable to other settings both in Africa and globally .

###24534756
OBJECTIVE	To determine the safety , tolerability and signs of efficacy of MOR103 , a human monoclonal antibody to granulocyte-macrophage colony-stimulating factor ( GM-CSF ) , in patients with rheumatoid arthritis ( RA ) .
METHODS	Patients with active , moderate RA were enrolled in a randomised , multicentre , double-blind , placebo-controlled , dose-escalation trial of intravenous MOR103 ( 0.3 , 1.0 or 1.5 mg/kg ) once a week for 4weeks , with follow-up to 16weeks .
METHODS	The primary outcome was safety .
RESULTS	Of the 96 randomised and treated subjects , 85 completed the trial ( n = 27 , 24 , 22 and 23 for pooled placebo and MOR103 0.3 , 1.0 and 1.5 mg/kg , respectively ) .
RESULTS	Treatment emergent adverse events ( AEs ) in the MOR103 groups were mild or moderate in intensity and generally reported at frequencies similar to those in the placebo group .
RESULTS	The most common AE was nasopharyngitis .
RESULTS	In two cases , AEs were classified as serious because of hospitalisation : paronychia in a placebo subject and pleurisy in a MOR103 0.3 mg/kg subject .
RESULTS	Both patients recovered fully .
RESULTS	In exploratory efficacy analyses , subjects in the MOR103 1.0 and 1.5 mg/kg groups showed significant improvements in Disease Activity Score-28 scores and joint counts and significantly higher European League Against Rheumatism response rates than subjects receiving placebo .
RESULTS	MOR103 1.0 mg/kg was associated with the largest reductions in disease activity parameters .
CONCLUSIONS	MOR103 was well tolerated and showed preliminary evidence of efficacy in patients with active RA .
CONCLUSIONS	The data support further investigation of this monoclonal antibody to GM-CSF in RA patients and potentially in those with other immune-mediated inflammatory diseases .
BACKGROUND	NCT01023256 .

###24555502
BACKGROUND	Home visiting nurses ( HVNs ) have long been part of home and community-based care interventions designed to meet the needs of functionally declining older adults .
BACKGROUND	However , only one of the studies including HVNs that have demonstrated successful impacts on Activities of Daily Living ( ADL ) has reported how those interventions affected individual ADLs such as bathing , instead reporting the effect on means of various ADL indices and scales .
BACKGROUND	Reporting impacts on means is insufficient since the same mean can consist of many different combinations of individual ADL impairments .
BACKGROUND	The purpose of our study was to identify which individual ADLs were affected by a specific HVN intervention .
METHODS	This is a secondary analysis comparing two arms of a randomized controlled study that enrolled Medicare patients ( mean age = 76.8 years ; 70 % female ) with considerable ADL impairment .
METHODS	At baseline difficulty with individual ADLs ranged from a low of 16.0 % with eating to a high of 78.0 % with walking .
METHODS	Through monthly home visits , the HVN focused on empowering patients and using behavior change approaches to facilitate chronic disease self-management .
METHODS	Three categories of analyses were used to compare difficulty with and dependence in 6 individual ADLs between the HVN ( n = 237 ) and care as usual ( n = 262 ) groups ( total N = 499 ) at 22 months after study entry : ( 1 ) unadjusted analyses that strictly depend on random assignment , ( 2 ) multinomial logistic regression analyses adjusting for baseline risk factors , and ( 3 ) multinomial regression analyses that include variables reporting post-randomization healthcare use as well as the baseline risk factors .
RESULTS	Compared to care as usual , patients receiving the HVN intervention had less difficulty performing bathing at 22 months .
RESULTS	However , there were no effects for difficulty performing the other 5 ADLs .
RESULTS	While no effects were found for lower levels of dependence for any ADLs , impacts were detected for the most dependent levels of 4 ADLs : patients experienced less dependence in walking and transferring , a substitution effect for toileting , and more dependence in eating .
CONCLUSIONS	Future research is needed to confirm these findings and determine how HVN interventions affect individual ADLs of older adults with multiple ADLs .

###24570015
BACKGROUND	Endoscopic submucosal dissection ( ESD ) is the gold standard technique for en bloc resection of large superficial tumors in the upper and lower gastrointestinal tract .
BACKGROUND	Little is known about the management of epigastric pain after ESD of gastric neoplasms .
BACKGROUND	This study investigated the utility and safety of single-dose , perioperative , intravenous dexamethasone for epigastric pain relief following ESD .
METHODS	The efficacy of intravenous dexamethasone 0.15 mg/kg ( DEXA group ) compared with saline-only placebo ( placebo ) for epigastric pain after ESD of early gastric neoplasms was assessed in a double-blinded , placebo-controlled trial .
METHODS	Patients completed a questionnaire about present pain intensity ( PPI ) and short-form McGill pain ( SF-MP ) categories for immediate and 6 - , 12 - , and 24-h postoperative periods .
METHODS	The primary outcome variable was PPI at 6 h following ESD .
METHODS	Secondary outcome variables included pain medication , SF-MP scores , complications , second-look endoscopic findings , and length of stay .
RESULTS	A total of 36 patients participated in the study .
RESULTS	The mean 6-h PPI value was lower ( p < 0.001 ) in the DEXA group ( 1.61 0.21 ) than in the placebo group ( 2.66 0.19 ) .
RESULTS	The total 6-h SF-MP score , especially the sensory domain , was higher ( p = 0.054 ) in the placebo group ( 11.56 0.75 ) than in the DEXA group ( 8.89 0.75 ) .
RESULTS	Tramadol for epigastric pain relief was more frequent ( p = 0.026 ) in the placebo group ( 44.4 % ) than in the DEXA group ( 11.1 % ) .
RESULTS	No differences were noted between groups in length of stay or complications , including acute or delayed bleeding .
RESULTS	The distribution of artificial ulcer patterns at 48-h post-ESD as determined by second-look endoscopy was similar in both groups .
CONCLUSIONS	Single-dose perioperative intravenous dexamethasone after ESD effectively relieved epigastric pain 6 h postoperatively .

###24344086
BACKGROUND	Dabigatran and warfarin have been compared for the treatment of acute venous thromboembolism ( VTE ) in a previous trial .
BACKGROUND	We undertook this study to extend those findings .
RESULTS	In a randomized , double-blind , double-dummy trial of 2589 patients with acute VTE treated with low-molecular-weight or unfractionated heparin for 5 to 11 days , we compared dabigatran 150 mg twice daily with warfarin .
RESULTS	The primary outcome , recurrent symptomatic , objectively confirmed VTE and related deaths during 6 months of treatment occurred in 30 of the 1279 dabigatran patients ( 2.3 % ) compared with 28 of the 1289 warfarin patients ( 2.2 % ; hazard ratio , 1.08 ; 95 % confidence interval [ CI ] , 0.64-1 .80 ; absolute risk difference , 0.2 % ; 95 % CI , -1.0 to 1.3 ; P < 0.001 for the prespecified noninferiority margin for both criteria ) .
RESULTS	The safety end point , major bleeding , occurred in 15 patients receiving dabigatran ( 1.2 % ) and in 22 receiving warfarin ( 1.7 % ; hazard ratio , 0.69 ; 95 % CI , 0.36-1 .32 ) .
RESULTS	Any bleeding occurred in 200 dabigatran ( 15.6 % ) and 285 warfarin ( 22.1 % ; hazard ratio , 0.67 ; 95 % CI , 0.56-0 .81 ) patients .
RESULTS	Deaths , adverse events , and acute coronary syndromes were similar in both groups .
RESULTS	Pooled analysis of this study RE-COVER II and the RE-COVER trial gave hazard ratios for recurrent VTE of 1.09 ( 95 % CI , 0.76-1 .57 ) , for major bleeding of 0.73 ( 95 % CI , 0.48-1 .11 ) , and for any bleeding of 0.70 ( 95 % CI , 0.61-0 .79 ) .
CONCLUSIONS	Dabigatran has similar effects on VTE recurrence and a lower risk of bleeding compared with warfarin for the treatment of acute VTE .
BACKGROUND	www.clinicaltrials.gov .
BACKGROUND	Unique identifiers : NCT00680186 and NCT00291330 .

###25306897
BACKGROUND	Peer teaching is now used in medical education with its value increasingly being recognised .
BACKGROUND	It is not yet established whether students differ in their satisfaction with teaching by peer-teachers compared to those taught by academic or clinical staff .
BACKGROUND	This study aimed to establish satisfaction with communication skills teaching between these three teaching groups .
METHODS	Students participated in a role-play practical facilitated either by clinicians , peer-teachers or non-clinical staff .
METHODS	A questionnaire was administered to first-year medical students after participating in a communication skills role-play session asking students to evaluate their satisfaction with the session .
METHODS	Data were analysed in SPSS 20 .
RESULTS	One hundred and ninety eight students out of 239 ( 83 % ) responded .
RESULTS	Students were highly satisfied with the teaching session with no difference in satisfaction scores found between those sessions taught by peers , clinical and non-clinical staff members .
RESULTS	158 ( 80 % ) considered the session useful and 139 ( 69 % ) strongly agreed tutors facilitated their development .
RESULTS	There was no significant difference in satisfaction scores based on tutor background .
CONCLUSIONS	Satisfaction is as high when tutored by peer-teachers compared to clinicians or non-clinical staff .
CONCLUSIONS	Constructive feedback is welcomed from a range of personnel .
CONCLUSIONS	Final-year students could play an increasing role in the teaching of pre-clinical medical students .

###25278086
BACKGROUND	The immunogenicity , reactogenicity , and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine ( PHiD-CV ) co-administered with routine childhood vaccines were evaluated among infants from Singapore and Malaysia , where PHiD-CV has been licensed .
METHODS	In the primary vaccination phase , 298 infants from Singapore and 168 infants from Malaysia were randomised to receive the Phase III Clinical ( Clin ) or the Commercial ( Com ) lot of PHiD-CV at 2 , 3 , and 5 months of age .
METHODS	In the booster vaccination phase , 238 toddlers from Singapore received one dose of the PHiD-CV Commercial lot at 18-21 months of age .
METHODS	Immune responses to pneumococcal polysaccharides were measured using 22F-inhibition enzyme-linked immunosorbent assay ( ELISA ) and functional opsonophagocytic activity ( OPA ) assay and to protein D , using ELISA .
RESULTS	Immune responses induced by primary vaccination with the PHiD-CV Commercial lot were non-inferior to the Phase III Clinical lot in terms of adjusted antibody geometric mean concentration ( GMC ) ratios for each vaccine pneumococcal serotype and protein D. For each vaccine pneumococcal serotype , 93.6 % and 88.5 % of infants from Malaysia and Singapore had post-primary vaccination antibody concentrations 0.2 g/mL and OPA titres 8 , in the Clin and Com groups , respectively .
RESULTS	For each vaccine pneumococcal serotype , 60.8 % and 98.2 % of toddlers from Singapore had pre - and post-booster antibody concentrations 0.2 g/mL , in the Clin and Com groups , respectively .
RESULTS	All children , except one , had measurable anti-protein D antibodies and the primary and booster doses of the co-administered vaccines were immunogenic .
RESULTS	The incidence of each grade 3 solicited symptom was 11.1 % in both study phases .
RESULTS	No serious adverse events considered causally related to vaccination were reported throughout the study .
CONCLUSIONS	PHiD-CV given as three-dose primary vaccination to infants in Singapore and Malaysia and booster vaccination to toddlers in Singapore was shown to be immunogenic with a clinically acceptable-safety profile.This study has been registered at http://www.clinicaltrials.govNCT00808444 and NCT01119625 .

###25277614
BACKGROUND	Recent trials of fish oil for the prevention of atrial fibrillation ( AF ) recurrence have provided mixed results .
BACKGROUND	Notable uncertainties in the existing evidence base include the roles of high-dose fish oil , inflammation , and oxidative stress in patients with paroxysmal or persistent AF not receiving conventional antiarrhythmic ( AA ) therapy .
OBJECTIVE	The aim of this study was to evaluate the influence of high-dose fish oil on AF recurrence , inflammation , and oxidative stress parameters .
METHODS	We performed a double-blind , randomized , placebo-controlled , parallel-arm study in 337 patients with symptomatic paroxysmal or persistent AF within 6 months of enrollment .
METHODS	Patients were randomized to fish oil ( 4 g/day ) or placebo and followed , on average , for 271 129 days .
RESULTS	The primary endpoint was time to first symptomatic or asymptomatic AF recurrence lasting > 30 s. Secondary endpoints were high-sensitivity C-reactive protein ( hs-CRP ) and myeloperoxidase ( MPO ) .
RESULTS	The primary endpoint occurred in 64.1 % of patients in the fish oil arm and 63.2 % of patients in the placebo arm ( hazard ratio : 1.10 ; 95 % confidence interval : 0.84 to 1.45 ; p = 0.48 ) .
RESULTS	hs-CRP and MPO were within normal limits at baseline and decreased to a similar degree at 6 months ( hs-CRP , 11 % vs.-11 % ; MPO,-5 % vs.-9 % for fish oil vs. placebo , respectively ; p value for interaction = NS ) .
CONCLUSIONS	High-dose fish oil does not reduce AF recurrence in patients with a history of AF not receiving conventional AA therapy .
CONCLUSIONS	Furthermore , fish oil does not reduce inflammation or oxidative stress markers in this population , which may explain its lack of efficacy .
CONCLUSIONS	( Multi-center Study to Evaluate the Effect of N-3 Fatty Acids [ OMEGA-3 ] on Arrhythmia Recurrence in Atrial Fibrillation [ AFFORD ] ; NCT01235130 ) .

###24985195
BACKGROUND	In patients with ulnar neuropathy at the elbow ( UNE ) , short-segment nerve conduction studies ( NCS ) are rarely performed due to unclear reference values .
BACKGROUND	We excluded controls with subclinical UNE , calculated normative values , and tested them in UNE patients .
METHODS	Clinical examination , ultrasonography ( US ) , and 2-cm short-segment ulnar motor NCS across the elbow were performed in 49 controls and 67 UNE patients .
METHODS	In controls , subclinical UNE was diagnosed if at least 2 studies were outside the reference limits in the same 2-cm segment .
RESULTS	Exclusion of controls with subclinical UNE produced less stringent normative values ( 2-cm conduction velocity : 25 to 31 m/s ; US cross-sectional area : 11.6 to 9.6 mm2 ) , which raised diagnostic sensitivity ( short-segment NCS : 76 % to 90 % ; 10-cm NCS : 72 % to 85 % , US : 43 % to 79 % ) .
CONCLUSIONS	We propose the use of our normative values in patients with clinically definite and probable UNE after exclusion of alternative diagnoses .

###24842182
BACKGROUND	Adductor canal blocks have shown promise in reducing postoperative pain in total knee arthroplasty patients .
BACKGROUND	No randomized , controlled studies , however , evaluate the opioid-sparing benefits of a continuous 0.2 % ropivacaine infusion at the adductor canal .
BACKGROUND	We hypothesized that a continuous adductor canal block would decrease postoperative opioid consumption .
METHODS	Eighty subjects presenting for primary unilateral total knee arthroplasty were randomized to receive either a continuous ultrasound-guided adductor canal block with 0.2 % ropivacaine or a sham catheter .
METHODS	All subjects received a preoperative single-injection femoral nerve block with spinal anesthesia as is standard of care at our institution .
METHODS	Cumulative IV morphine consumption 48 hours after surgery was evaluated with analysis of covariance , adjusted for baseline characteristics .
METHODS	Secondary outcomes included resting pain scores ( numeric rating scale ) , peak pain scores during physical therapy on postoperative days 1 and 2 , quadriceps maximum voluntary isometric contraction , distance ambulated during physical therapy , postoperative nausea and vomiting , and satisfaction with analgesia .
RESULTS	Eighty subjects were randomized , and 76 completed the study per-protocol .
RESULTS	The least-square mean difference in cumulative morphine consumption over 48 hours ( block-sham ) was -- 16.68 mg ( 95 % confidence interval , -29.78 to -3.59 , P = 0.013 ) .
RESULTS	Total morphine use between 24 and 48 hours ( after predicted femoral nerve block resolution ) also differed by least-square mean -11.17 mg ( 95 % confidence interval , : -19.93 to -2.42 , P = 0.013 ) .
RESULTS	Intention-to-treat analysis was similar to the per-protocol results .
RESULTS	Functional outcomes revealed subjects in the adductor canal catheter group had better quadriceps strength ( P = 0.010 ) and further distance ambulated ( P = 0.034 ) on postoperative day 2 .
CONCLUSIONS	A continuous adductor canal block for total knee arthroplasty reduces opioid consumption compared with that of placebo in the first 48 hours after surgery .
CONCLUSIONS	Other outcomes including quadriceps strength , distance ambulated , and pain scores all show benefit from an adductor canal catheter after total knee arthroplasty but require further study before being interpreted as conclusive .

###25252482
OBJECTIVE	To determine the effect of Tamsulosin , as adjunctive medical therapy after Extracorporeal Shock Wave Lithotripsy for renal stones on rate of stone clearance , clearance time , pain intensity during stone clearance , steinstrasse formation and auxiliary surgical intervention required .
METHODS	A prospective randomized controlled study was carried out in 120 patients who undeiwent ESWL for renal stones of 0.5-2 .0 cm .
METHODS	They were randomized into study and control group in which Tamsulosin 0.4 mg/day was given in former as an adjunctive medical therapy .
METHODS	All patients underwent ESWL every 2 weeks until complete stone clearance for 8 weeks .
METHODS	The parameters assessed were stone clearance , clearance time , pain intensity and effect on steinstrasse .
RESULTS	Of the 120 patients 60 were in each group .
RESULTS	The stone clearance rate was greater in study than in control group , 58 ( 96.7 % ) vs. 48 ( 80 % ) respectively , ( p < 0.004 ) .
RESULTS	The mean stone clearance time was observed earlier in study group as compared to control group with significant statistical difference in stone size between 0.6-1 .
RESULTS	Scm.The mean intensity of pain patients experienced according to Visual analogue scale ( VAS ) was significantly less in study group ( p < 0.002 ) .
RESULTS	The rate of steinstrasse formation was observed to be higher in control than in study group 15 ( 25 % ) vs 6 ( 10 % ) respectively ( p < 0.003 ) , while its spontaneous clearance was higher in study group than in control group 83.3 % vs 33.3 % ( p < 0.03 ) .
CONCLUSIONS	Tamsulosin significantly increases stone clearance after shock wave lithotripsy for renal stones .
CONCLUSIONS	It also appeared to facilitate earlier stone clearance , reduces severity of pain , reduces the incidence of steinstrasse formation and tends to facilitate its spontaneous clearance .

###24353020
BACKGROUND	Dyspnea is considered as one of the most frequent and distressing symptoms in patients with advanced cancer , and systemic administration of morphine has been reported to have beneficial effect on this complaint .
OBJECTIVE	The effect of red morphine drops ( RMD ) given orally and kept in the mouth as long as possible before swallowing to alleviate dyspnea was compared to the effect of morphine given subcutaneously ( SCM ) in a double-blind , double-dummy trial .
METHODS	Twenty consecutive terminally ill patients with primary lung cancer or lung metastases admitted to Sankt Lukas Hospice were included in the study .
METHODS	All patients had dyspnea at rest , and they received either 1/12 of their 24-hour morphine dose as RMD or 60 percent of this dose as SCM .
METHODS	Perceived breathlessness was evaluated on a Visual Analogue Scale ( VAS ) during a 60 minutes observation time , and pulse rate , respiratory rate and oxygen saturation were assessed as well .
RESULTS	Compared to baseline both RMD and SCM showed a small , but statistical significant effect on VAS ( mean decrease of 1.1 [ RMD ] and 1.7 [ SCM ] ) and pulse rate ( mean decrease of 4 per minute [ RMD ] and 6 per minute [ SCM ] ) , the effect being significantly larger after SCM .
CONCLUSIONS	The study confirms the beneficial effect of morphine on dyspnea in terminally ill patients , and we conclude that RMD is an attractive alternative to injected morphine , when self-administration is preferable .

###24293583
OBJECTIVE	Rheumatoid arthritis ( RA ) treatment recommendations suggest target attainment within the first 3 months of therapy , yet delayed clinical responses can occur .
OBJECTIVE	This analysis assessed the longterm clinical , functional , and radiographic outcomes associated with delayed responses to methotrexate ( MTX ) monotherapy or to the combination of adalimumab ( ADA ) + MTX .
METHODS	In this posthoc analysis , patients with early RA who received MTX monotherapy or ADA + MTX in the PREMIER study were categorized based on clinical responses at 3 and 6 months [ American College of Rheumatology response , 28-joint Disease Activity Score ( DAS28 ) - C-reactive protein ( CRP ) improvement and targets ] .
METHODS	`` Month 3 '' responders met the clinical measure at both months 3 and 6 , and `` Month 6 '' responders met the clinical measure only at Month 6 .
METHODS	The odds of achieving longterm outcomes [ remission ( DAS28-CRP < 2.6 ) , normal function ( Health Assessment Questionnaire-Disability Index < 0.5 ) , or rapid radiographic progression ( modified total Sharp score > 3 U/yr ) ] were modeled using logistic regression , including treatment , response , and interaction .
RESULTS	A delayed or low-level response was associated with poorer longterm outcomes .
RESULTS	Generally , MTX Month 6 responders demonstrated worse clinical , functional , and radiographic outcomes than Month 3 MTX and Month 3 or 6 ADA + MTX responders .
RESULTS	Although similar longterm benefit was observed for ADA + MTX responders , delayed ( Month 6 ) responders exhibited downward trends in clinical , functional , and radiographic outcomes that were comparable with those experienced by Month 3 MTX responders .
CONCLUSIONS	Response speed and magnitude predict longterm outcomes in patients with early RA treated with MTX or ADA + MTX .
CONCLUSIONS	MTX-treated patients failing to demonstrate a Month 3 clinical response have less-favorable outcomes than other groups , while outcomes in ADA + MTX Month 3 and Month 6 responders tended to be comparable .

###24825135
BACKGROUND	Perioral dermatitis ( POD ) is a common skin disease , and extending the range of treatments available for this condition is important .
OBJECTIVE	To evaluate the safety , efficacy and tolerability of praziquantel 3 % ointment as monotherapy .
METHODS	This was a single-centre , randomized , single-blind , vehicle-controlled pilot study in adult patients ( n = 46 ) with 4weeks of treatment and 4weeks of follow-up .
METHODS	Efficacy was assessed clinically using the Investigator 's Global Assessment ( IGA ) and the Perioral Dermatitis Severity Index ( PODSI ) .
METHODS	Quality of life ( QOL ) was determined by the Dermatology Quality of Life Index ( DLQI ) .
RESULTS	PODSI was significantly lower in the praziquantel group than in the placebo ( vehicle ) group , both during treatment and period .
RESULTS	Mean IGA score showed a statistically significant therapeutic advantage of praziquantel over placebo at week 4 ( P < 0.001 ) .
RESULTS	The praziquantel group experienced a greater improvement in mean DLQI .
RESULTS	No serious treatment-related adverse events occurred in either group .
CONCLUSIONS	Praziquantel ointment 3 % effectively improves POD symptoms and QOL .

###24578289
OBJECTIVE	The aim of this study was to determine whether an interactive computer program could improve patient knowledge regarding genetic screening and diagnostic concepts .
METHODS	In this randomized trial , women 6-26weeks ' gestation were assigned to standard care with provider-based counseling or to augmented counseling with an interactive computer program .
METHODS	The computer-based tool conveyed information about genetic testing options .
METHODS	Women were administered a 23-item test of content knowledge immediately and 2-4weeks after exposure .
METHODS	Test scores were compared between groups at both points using T-tests .
RESULTS	A total of 150 women were randomized equally between groups .
RESULTS	Groups were similar with regard to demographic characteristics .
RESULTS	Women randomized to the interactive tool correctly answered a significantly greater proportion of questions than those who received standard counseling ( 69.4 % 14.2 % vs. 46.0 % 15.2 % , p < 0.001 ) on the immediate questionnaire .
RESULTS	One hundred and twenty-three ( 82 % ) participants participated in the follow-up test .
RESULTS	Women randomized to the tool continued to correctly answer a significantly greater proportion of questions ( 60.6 % 16 % vs. 49.7 % 18.9 % , p = 0.001 ) .
RESULTS	Education , health literacy , electronic health literacy , and other discussions with providers were not associated with a differential benefit from the educational intervention .
CONCLUSIONS	A patient-directed interactive computer program may help providers to convey relevant information about genetic screening and diagnostic concepts .

###24646528
OBJECTIVE	To assess the safety and efficacy of antibiotics treatment for suspected acute uncomplicated appendicitis and to monitor the long term follow-up of non-operated patients .
BACKGROUND	Right lower quadrant abdominal pain is a common cause of emergency department admission .
BACKGROUND	The natural history of acute appendicitis nonoperatively treated with antibiotics remains unclear .
METHODS	In 2010 , a total of 159 patients [ mean AIR ( Appendicitis Inflammatory Response ) score = 4.9 and mean Alvarado score = 5.2 ] with suspected appendicitis were enrolled and underwent nonoperative management ( NOM ) with amoxicillin/clavulanate .
METHODS	The follow-up period was 2 years .
RESULTS	Short-term ( 7 days ) NOM failure rate was 11.9 % .
RESULTS	All patients with initial failures were operated within 7 days .
RESULTS	At 15 days , no recurrences were recorded .
RESULTS	After 2 years , the overall recurrence rate was 13.8 % ( 22/159 ) ; 14 of 22 patients were successfully treated with further cycle of amoxicillin/clavulanate .
RESULTS	No major side effects occurred .
RESULTS	Abdominal pain assessed by the Numeric Rating Scale and the visual analog scale ; median Numeric Rating Scale score was 3 at 5 days and 2 after 7 days .
RESULTS	Mean length of stay of nonoperatively managed patients was 0.4 days , and mean sick leave period was 5.8 days .
RESULTS	Long-term efficacy of NOM treatment was 83 % ( 118 patients recurrence free and 14 patients with recurrence nonoperatively managed ) .
RESULTS	None of the single factors forming the Alvarado or AIR score were independent predictors of failure of NOM or long-term recurrence .
RESULTS	Alvarado and AIR scores were the only independent predictive factors of NOM failure after multivariate analysis , but both did not correlate with recurrences .
RESULTS	Overall costs of NOM and antibiotics were & OV0556 ; 316.20 per patient .
CONCLUSIONS	Antibiotics for suspected acute appendicitis are safe and effective and may avoid unnecessary appendectomy , reducing operation rate , surgical risks , and overall costs .
CONCLUSIONS	After 2 years of follow-up , recurrences of nonoperatively treated right lower quadrant abdominal pain are less than 14 % and may be safely and effectively treated with further antibiotics .

###24620850
OBJECTIVE	Evidence is accumulating , predominantly among clinical trials in adults , that yoga improves blood pressure ( BP ) control , with downregulation of the hypothalamic-pituitary-adrenal ( HPA ) axis and the sympathetic nervous system ( SNS ) projected as underlying mechanisms .
OBJECTIVE	This pilot study assessed whether Hatha yoga has the potential to reduce BP among youth and whether dampening of the SNS and/or HPA activity is a likely pathway of change .
METHODS	Thirty-one seventh graders were randomly assigned to a Hatha yoga program ( HYP ) or attention control ( AC ) music or art class .
METHODS	Baseline and 3-month evaluations included resting BP ; overnight urine samples ; and saliva collected at bedtime , upon awakening , and at 30 and 60 minutes after awakening for - amylase and cortisol assays .
RESULTS	Twenty-eight ( 14 in the HYP group and 14 in the AC group ) students were assessed both before and after the intervention .
RESULTS	BP changes from pre - to post-intervention were -3.0 / -2.0 mmHg for the HYP group and -0.07 / -0.79 mmHg for the AC group ( p = 0.30 and 0.57 , respectively ) .
RESULTS	Changes in systolic BP ( SBP ) / diastolic BP ( DBP ) for the prehypertensive ( 75th-94th percentiles for SBP ) subgroup analyses were -10.75 / -8.25 mmHg for the HYP group ( n = 4 ) versus 1.8 / 1.0 mmHg for the AC group ( n = 5 ) ( p for SBP = 0.02 ; p for DBP = 0.09 ) .
RESULTS	Although no statistically significant group differences were observed with changes in SNS or HPA awakening curves ( area under curve for - amylase and cortisol , respectively ) , a small to moderate effect size was seen favoring a reduction of - amylase activation for the HYP group ( Cohen d = 0.34 ; prehypertensive d = 0.20 ) .
CONCLUSIONS	A school-based Hatha yoga program demonstrated potential to decrease resting BP , particularly among prehypertensive youth .
CONCLUSIONS	Reduced SNS drive may be an underlying neurohormonal pathway beneficially affected by the program .
CONCLUSIONS	A large-scale efficacy/effectiveness randomized clinical trial is warranted .

###25131734
BACKGROUND	To ensure that developing countries have the option to produce inactivated poliovirus vaccine ( IPV ) , the Global Polio Eradication Initiative has promoted the development of an IPV using Sabin poliovirus strains ( Sabin IPV ) .
BACKGROUND	This trial assessed the reactogenicity and immunogenicity of Sabin IPV and adjuvanted Sabin IPV in healthy adults in Cuba .
METHODS	This is a randomized , controlled phase I trial , enrolling 60 healthy ( previously vaccinated ) male human volunteers , aged 19-23 years to receive one dose of either Sabin IPV ( 20:32:64 DU/dose ) , adjuvanted Sabin IPV ( 10:16:32 DU/dose ) , or conventional Salk IPV ( 40:8:32 DU/dose ) .
METHODS	The primary endpoint for reactogenicity relied on monitoring of adverse events .
METHODS	The secondary endpoint measured boosting immune responses ( i.e. seroconversion or 4-fold rise ) of poliovirus antibody , assessed by neutralization assays .
RESULTS	Sixty subjects fulfilled the study requirements .
RESULTS	No serious adverse events reported were attributed to trial interventions during the 6-month follow-up period .
RESULTS	Twenty-eight days after vaccination , boosting immune responses against poliovirus types 1-3 were between 90 % and 100 % in all vaccination groups .
RESULTS	There was a more than 6-fold increase in median antibody titers between pre - and post-vaccination titers in all vaccination groups .
CONCLUSIONS	Both Sabin IPV and adjuvanted Sabin IPV were well tolerated and immunogenic against all poliovirus serotypes .
CONCLUSIONS	This result suggests that the aluminum adjuvant may allow a 50 % ( or higher ) dose reduction .

###25216506
OBJECTIVE	Objectives of this ancillary analysis of a prospective , prevention study among Asian Indians with impaired glucose tolerance ( IGT ) were a ) to quantify the reduction in incident diabetes at 24 months in participants who achieved normal glucose tolerance ( NGT ) at 6 months ( NGT-6 m ) compared with the other participants , b ) the factors influencing the reversal to NGT at the end of the study at 24 months ( NGT-24 m ) , and c ) to assess changes in cardiometabolic risk factors in different categories of dysglycemia at 24 months .
METHODS	Data from a 2-year primary prevention trial were used .
METHODS	Effect of reversion to NGT-6 m on incidence of type 2 diabetes mellitus ( T2DM ) was analyzed using the Cox proportional hazards model .
METHODS	Predictive variables for reversal to NGT were identified using multiple logistic regression analysis .
METHODS	Changes in cardiometabolic risk factors were estimated according to the final glycemic status using fixed-effect , mixed-linear regression modeling .
RESULTS	The risk of T2DM in 2 years was lower by 75 % in NGT-6 m group ( hazard ratio 0.25 [ 95 % CI 0.12-0 .52 ] ) .
RESULTS	Predictive variables for reversal to NGT-24 m were good baseline - cell function ( odds ratio [ OR ] 2.79 [ 95 % CI 2.30-3 .40 ] ) and its further improvement ( OR 5.70 [ 95 % CI 4.58-7 .08 ] ) , and NGT-6 m ( OR 2.10 [ 95 % CI 1.14-3 .83 ] ) .
RESULTS	BMI decreased in those who reverted to NGT .
RESULTS	Deterioration to T2DM was associated with an increase in the levels of cardiometabolic risk factors .
CONCLUSIONS	Early reversion to NGT by lifestyle intervention in prediabetic men was associated with a significant reduction in subsequent incidence of diabetes .
CONCLUSIONS	Good baseline - cell function and its further improvement and NGT-6 m were associated with reversion to NGT-24 months .
CONCLUSIONS	Reversion to NGT was associated with modest improvements , whereas conversion to T2DM was associated with significant worsening of the cardiometabolic risk profile .

###24359716
OBJECTIVE	This one-year study investigated whether the Manitoba Provincial Health Contact program for congestive heart failure ( CHF ) is a cost-effective intervention relative to the standard treatment .
METHODS	Individual patient-level , randomized clinical trial of cost-effective model using data from the Health Research Data Repository at the Manitoba Centre for Health Policy , University of Manitoba .
METHODS	A total of 179 patients aged 40 and over with a diagnosis of CHF levels II to IV were recruited from Winnipeg and Central Manitoba and randomized into three treatment groups : one receiving standard care , a second receiving Health Lines ( HL ) intervention and a third receiving Health Lines intervention plus in-house monitoring ( HLM ) .
METHODS	A cost-effectiveness study was conducted in which outcomes were measured in terms of QALYs derived from the SF-36 and costs using 2005 Canadian dollars .
METHODS	Costs included intervention and healthcare utilization .
METHODS	Bootstrap-resampled incremental cost-effectiveness ratios were computed to take into account the uncertainty related to small sample size .
RESULTS	The total per-patient mean costs ( including intervention cost ) were not significantly different between study groups .
RESULTS	Both interventions ( HL and HLM ) cost less and are more effective than standard care , with HL able to produce an additional QALY relative to HLM for $ 2,975 .
RESULTS	The sensitivity analysis revealed that there is an 85.8 % probability that HL is cost-effective if decision-makers are willing to pay $ 50,000 .
CONCLUSIONS	Findings demonstrate that the HL intervention from the Manitoba Provincial Health Contact program for CHF is an optimal intervention strategy for CHF management compared to standard care and HLM .

###24873986
BACKGROUND	Potential interactions between vaccines may compromise the immunogenicity and/or safety of individual vaccines so must be assessed before concomitant administration is recommended .
BACKGROUND	In this study , the immunogenicity and safety of travel vaccines against Japanese encephalitis ( JEV ) and rabies ( PCECV ) administered together with or without a quadrivalent meningococcal glycoconjugate ACWY-CRM vaccine were evaluated ( NCT01466387 ) .
METHODS	Healthy adults aged 18 to 60 years were randomized to one of four vaccine regimens : JEV + PCECV + MenACWY-CRM , JEV + PCECV , PCECV or MenACWY-CRM .
METHODS	Immunogenicity at baseline and 28 days post-complete vaccination was assessed by serum bactericidal assay using human complement or neutralization tests .
METHODS	Adverse events ( AEs ) were collected throughout the study period .
RESULTS	JEV + PCECV + MenACWY-CRM was non-inferior to JEV + PCECV .
RESULTS	Post-vaccination seroprotective neutralizing titers or concentrations were achieved in 98-99 % ( JE ) and 100 % ( rabies ) of subjects across the vaccine groups .
RESULTS	Antibody responses to vaccine meningococcal serogroups were in the same range for MenACWY-CRM and JEV + PCECV + MenACWY-CRM .
RESULTS	Rates of reporting of AEs were similar for JEV + PCECV and JEV + PCECV + MenACWY-CRM .
CONCLUSIONS	MenACWY-CRM was administered with an inactivated adjuvanted JE and a purified chick embryo cell-culture rabies vaccine without compromising immunogenicity or safety of the individual vaccines .
CONCLUSIONS	These data provide evidence that MenACWY-CRM could be effectively incorporated into travel vaccination programs .
BACKGROUND	NCT01466387 .

###24652518
OBJECTIVE	Individual variation in response and duration of anti-vascular endothelial growth factor ( VEGF ) therapy is seen among patients with neovascular age-related macular degeneration .
OBJECTIVE	Identification of genetic markers that affect clinical response may result in optimization of anti-VEGF therapy .
OBJECTIVE	To evaluate the pharmacogenetic relationship between genotypes of single-nucleotide polymorphisms ( SNPs ) in the VEGF signaling pathway and response to treatment with ranibizumab or bevacizumab for neovascular age-related macular degeneration .
METHODS	In total , 835 of 1149 patients ( 72.7 % ) participating in the Comparison of Age-Related Macular Degeneration Treatments Trials ( CATT ) at 43 CATT clinical centers .
METHODS	Each patient was genotyped for 7 SNPs in VEGFA ( rs699946 , rs699947 , rs833069 , rs833070 , rs1413711 , rs2010963 , and rs2146323 ) and 1 SNP in VEGFR2 ( rs2071559 ) using TaqMan SNP genotyping assays .
METHODS	Genotypic frequencies were compared with clinical measures of response to therapy at 1 year , including the mean visual acuity , mean change in visual acuity , at least a 15-letter increase , retinal thickness , mean change in total foveal thickness , presence of fluid on optical coherence tomography , presence of leakage on fluorescein angiography , mean change in lesion size , and mean number of injections administered .
METHODS	Differences in response by genotype were evaluated with tests of linear trend calculated from logistic regression models for categorical outcomes and linear regression models for continuous outcomes .
METHODS	The method of controlling the false discovery rate was used to adjust for multiple comparisons .
RESULTS	For each of the measures of visual acuity evaluated , no association was observed with any of the genotypes or with the number of risk alleles .
RESULTS	Four VEGFA SNPs demonstrated an association with retinal thickness : rs699947 ( P = .03 ) , rs833070 ( P = .04 ) , rs1413711 ( P = .045 ) , and rs2146323 ( P = .006 ) .
RESULTS	However , adjusted P values for these associations were all statistically nonsignificant ( range , P = .24 to P = .45 ) .
RESULTS	Among the participants in 2 as-needed groups , no association was found in the number of injections among the different genotypes or for the total number of risk alleles .
RESULTS	The effect of risk alleles on each clinical measure did not differ by treatment group , drug , or dosing regimen ( P > .01 for all ) .
CONCLUSIONS	This study provides evidence that no pharmacogenetic associations exist between the studied VEGFA and VEGFR2 SNPs and response to anti-VEGF therapy .
BACKGROUND	clinicaltrials.gov Identifier : NCT00593450 .

###24570490
OBJECTIVE	Atrial fibrillation after cardiac surgery is associated with increases in the risk of complications , length of intensive care unit stay , and cost of care .
OBJECTIVE	Beta blockers are effective for controlling myocardial ischemia and arrhythmia and suppressing inflammatory cytokines .
OBJECTIVE	The purpose of this study was to examine the effect of administrating a short-acting beta-adrenoceptor antagonist , landiolol , on postoperative atrial fibrillation .
METHODS	136 patients undergoing off-pump coronary artery bypass grafting were single-blindly assigned randomly to landiolol ( n = 68 ) and non-landiolol ( control , n = 68 ) groups .
METHODS	In the landiolol group , the beta blocker was administered from the beginning of the operation until postoperative day 2 .
METHODS	The primary endpoint was the incidence of atrial fibrillation until postoperative day 7 , and the secondary endpoints were the postoperative levels of troponin I , creatine kinase MB-isoenzyme , and C-reactive protein .
RESULTS	The incidence of atrial fibrillation was significantly lower in the landiolol group compared to the control group ( 13/68 , 19 % vs. 25/68 , 37 % , p = 0.02 , logrank test ) .
RESULTS	Landiolol also significantly reduced the postoperative peak C-reactive protein level compared to the control group ( 13255.4 vs. 16150.9 mgL ( -1 ) , p = 0.004 ) .
CONCLUSIONS	Low-dose continuous infusion of landiolol reduced the incidence of postoperative atrial fibrillation , and significantly suppressed inflammation .

###24649780
BACKGROUND	Magnesium sulphate ( MgSO4 ) , NMDA receptor antagonist , is known to reduce perioperative requirement of anesthetics and analgesics .
BACKGROUND	However , no studies assessed the effect of MgSO4 on onset and recovery from spinal anesthesia .
BACKGROUND	A prospective , randomised , double blind study was designed to assess the effect of intravenous ( IV ) MgSO4 on onset and recovery from spinal anesthesia and post operative analgesic requirement following below umbilical surgery .
METHODS	Sixty patients ( ASA class I & II ) were selected randomly and divided into two groups .
METHODS	Patients were given either MgSO4 50 mg kg ( -1 ) in 10 mL within 10 min , followed by an infusion of MgSO4 10 mg kg ( -1 ) hr ( -1 ) IV in 4mL ( MG group ) for 12 hrs or normal saline in same volume and rate for 12 hrs as used in MG group ( NS group ) .
METHODS	After initiating the infusion , spinal anesthesia was given with 0.5 % bupivacaine ( Hyperbaric ) 2.5 mL at L3/4 or L4/5 space .
METHODS	Time taken for sensory block at the level of T-10 and motor block ( modified Bromage Score-1 ) was noted .
METHODS	Postoperatively , time taken for recovery from spinal anesthesia , pain score and requirement of postoperative analgesic in 24 hours were observed and compared between the two groups .
RESULTS	The first rescue analgesia was required after 334 + / - 202 min in MG group and after 233 + / - 141 min in NS group with significant difference ( p < 0.05 ) .
RESULTS	The morphine required over 24 hours for analgesia was significantly less in MG group ( 3.99 + / - 1.25 mg ) as compared to NS group ( 7.13 + / - 2.68 mg ) ( p < 0.000 ) .
CONCLUSIONS	Intravenous MgSO4 improves postoperative analgesia without affecting the onset and recovery from spinal anesthesia .

###25099924
BACKGROUND	Sodium nitroprusside ( SNP ) is used to decrease arterial blood pressure ( BP ) during certain surgical procedures .
BACKGROUND	There are limited data regarding efficacy of BP control with SNP .
BACKGROUND	There are no data on patient and clinician factors that affect BP control .
BACKGROUND	We evaluated the dose-response relationship of SNP in infants and children undergoing major surgery and performed a quantitative assessment of BP control .
METHODS	One hundred fifty-three subjects at 7 sites received a blinded infusion followed by open-label SNP during operative procedures requiring controlled hypotension .
METHODS	SNP was administered by continuous infusion and titrated to maintain BP control ( mean arterial BP [ MAP ] within 10 % of clinician-defined target ) .
METHODS	BP was recorded using an arterial catheter .
METHODS	Statistical process control methodology was used to quantify BP control .
METHODS	A multivariable model assessed the effects of patient and procedural factors .
RESULTS	BP was controlled an average 45.4 % ( SD 23.9 % ; 95 % CI , 41.5 % -49.18 % ) of the time .
RESULTS	Larger changes in infusion rate were associated with worse BP control ( 7.99 % less control for 1 gkgmin increase in average titration size , P = 0.0009 ) .
RESULTS	A larger difference between a patient 's baseline and target MAP predicted worse BP control ( 0.93 % worse control per 1-mm Hg increase in MAP difference , P = 0.0013 ) .
RESULTS	Both effects persisted in multivariable models .
CONCLUSIONS	SNP was effective in reducing BP .
CONCLUSIONS	However , BP was within the target range less than half of the time .
CONCLUSIONS	No clinician or patient factors were predictive of BP control , although 2 inverse relationships were identified .
CONCLUSIONS	These relationships require additional study and may be best coupled with exposure-response modeling to propose improved dosing strategies when using SNP for controlled hypotension in the pediatric population .

###24766759
OBJECTIVE	Acamprosate has been available in the United States for treating alcohol use disorders ( AUDs ) for nearly a decade , yet few studies have examined its use within AUD treatment organizations .
OBJECTIVE	In addition to describing dissemination and adoption of acamprosate , this study provides novel data regarding organizational processes that underlie its implementation within adopting programs .
METHODS	Data were drawn from interviews with leaders of a nationally representative sample of 307 organizations delivering AUD treatment .
METHODS	Quantitative indicators of organizational characteristics , dissemination , adoption , and implementation of acamprosate , as well as qualitative measures of implementation processes , were measured during face-to-face interviews .
RESULTS	Only 18.0 % ( n = 55 ) of sampled organizations had adopted acamprosate for treating AUDs , and adoption was positively associated with accreditation , having a physician on staff , receiving information about acamprosate via pharmaceutical representatives , and learning about this medication from other treatment providers .
RESULTS	Within adopting programs , an average of 6.0 % of AUD patients were currently receiving acamprosate .
RESULTS	Numerous implementation challenges were identified , including appropriate patient selection , patient reluctance to be prescribed acamprosate , suboptimal adherence , its costs , and limited counselor training .
CONCLUSIONS	The limited adoption and implementation of acamprosate likely limits the potential public health impact of this adjunct to AUD treatment .
CONCLUSIONS	Research integrating the perspectives of organizational leaders , medical professionals , and patients is needed to determine whether specific strategies can address the implementation challenges identified in the current study and increase use of acamprosate in specialty AUD treatment settings .

###24581321
BACKGROUND	The ideal rehabilitation strategy following lumbar spinal fusion surgery has not yet been established .
BACKGROUND	This paper is a study protocol , describing the rationale behind and the details of a cognitive-behavioural rehabilitation intervention for lumbar spinal fusion patients based on the best available evidence .
BACKGROUND	Predictors of poor outcome following spine surgery have been identified to provide targets for the intervention , and the components of the intervention were structured in accordance with the cognitive-behavioural model .
BACKGROUND	The study aims to compare the clinical and economical effectiveness of a cognitive-behavioural rehabilitation strategy to that of usual care for patients undergoing lumbar spinal fusion surgery .
METHODS	The study is a randomized clinical trial including 96 patients scheduled for lumbar spinal fusion surgery due to degenerative disease or spondylolisthesis .
METHODS	Patients were recruited in the period October 2011 to July 2013 , and the follow-up period is one year from date of surgery .
METHODS	Patients are allocated on a 1:2 ratio ( control : intervention ) to either treatment as usual ( control group ) , which implies surgery and the standard postoperative rehabilitation , or in addition to this , a patient education focusing on pain behaviour and pain coping ( intervention group ) .
METHODS	It takes place in a hospital setting , and consists of six group-based sessions , managed by a multidisciplinary team of health professionals.The primary outcomes are disability ( Oswestry Disability Index ) and sick leave , while secondary outcomes include coping ( Coping Strategies Questionnaire ) , fear-avoidance belief ( Fear Avoidance Belief Questionnaire ) , pain ( Low Back Pain Rating Scale , pain index ) , mobility during hospitalization ( Cumulated Ambulation Score ) , generic health-related quality of life ( EQ-5D ) and resource use .
METHODS	Outcomes are measured using self report questionnaires , medical records and national registers .
CONCLUSIONS	It is expected that the intervention can provide better functional outcome , less pain and earlier return to work after lumbar spinal fusion surgery .
CONCLUSIONS	By combining knowledge and evidence from different knowledge areas , the project aims to provide new knowledge that can create greater consistency in patient treatment .
CONCLUSIONS	We expect that the results can make a significant contribution to development of guidelines for good rehabilitation of patients undergoing lumbar spinal fusion .
BACKGROUND	Current Controlled Trials ISRCTN42281022 .

###24943722
BACKGROUND	Artemisinin-based combination therapies ( ACTs ) are recommended for the treatment of acute uncomplicated falciparum malaria in many malaria-endemic countries .
BACKGROUND	Despite the emergence of artemisinin resistance , few alternative non-ACTs , including atovaquone-proguanil , are currently available .
METHODS	Plasmodium falciparum-infected Cameroonian children 5 years old ( n = 338 ) were randomly assigned to artesunate-amodiaquine , atovaquone-proguanil , or artesunate-atovaquone-proguanil treatment groups and followed for 28 days , according to the standard World Health Organization protocol .
METHODS	In vitro response to atovaquone and cytochrome b sequence of clinical isolates were determined .
RESULTS	Eight late failures and 16 failures ( 8 late and 8 early failures ) were observed after artesunate-amodiaquine and atovaquone-proguanil therapies , respectively .
RESULTS	Most late failures were due to reinfections .
RESULTS	Artesunate-atovaquone-proguanil was not associated with any failure .
RESULTS	After correction by genotyping , per-protocol analysis showed no difference in the efficacy of 3 drugs .
RESULTS	However , the proportion of atovaquone-proguanil-treated patients with positive smears on day 3 was much higher ( 36.0 % ; P < .05 ) than that of the artesunate-amodiaquine ( 2.9 % ) and artesunate-atovaquone-proguanil ( 1.0 % ) groups .
RESULTS	In vitro response and cytochrome b sequence did not indicate atovaquone resistance .
CONCLUSIONS	Atovaquone-proguanil was characterized by a slow blood schizontocidal action and resulted in early treatment failure in a few patients .
CONCLUSIONS	Artesunate-atovaquone-proguanil was a highly effective alternative treatment .
BACKGROUND	UMIN000003813 .

###26071347
BACKGROUND	There is some evidence to suggest that one or two doses of the HPV vaccine provides similar protection to the three-dose regimen .
BACKGROUND	The main aim of the study was to ascertain HPV-16 / 18 vaccine efficacy in both full and naive cohorts and to explore protection conferred against non-vaccine HPV types , by number of doses received .
METHODS	Summary data from the Costa Rica Vaccine Trial ( CVT ; NCT00128661 ) and ~ the PATRICIA trial ( NCT001226810 ) , two phase 3 , double-blind , randomised controlled clinical trials of the HPV-16 / 18 AS04-adjuvanted vaccine in young women , were combined in a post-hoc analysis ( GlaxoSmithKline [ GSK ] e-track number 202142 ) to investigate the efficacy of fewer than three doses of the HPV-16 / 18 vaccine after 4 years of follow-up .
METHODS	Women were randomly assigned to receive three doses of the HPV-16 / 18 vaccine or to a control vaccine ; yet , some received fewer doses .
METHODS	After exclusion of women with less than 12 months of follow-up or those who were HPV-16 / 18 DNA-positive at enrolment ( for the HPV-16 / 18 endpoint ) , we calculated vaccine efficacy against one-time detection of incident HPV infections after three , two , and one dose ( s ) .
METHODS	The primary study endpoint was one-time detection of first incident HPV-16 / 18 infections accumulated during the follow-up phase .
RESULTS	We assessed vaccine efficacy against incident HPV-16 / 18 infection in the modified total vaccinated cohort ( 22327 received three doses , 1185 two doses , 543 one dose ) .
RESULTS	Vaccine efficacy against incident HPV-16 / 18 infections for three doses was 770 % ( 95 % CI 747-791 ) , two doses was 760 % ( 620-853 ) , and one dose was 857 % ( 707-937 ) .
RESULTS	Vaccine efficacy against incident HPV-31 / 33/45 infections for three doses was 597 % ( 560-630 ) , two doses was 377 % ( 124-559 ) , and one dose was 366 % ( -54 to 622 ) .
RESULTS	Vaccine efficacy against incident HPV-16 / 18 infection for two-dose women who received their second dose at 1 month was 753 % ( 542-875 ) and 826 % ( 423-961 ) for those who received the second dose at 6 months ( CVT data only ) .
RESULTS	Vaccine efficacy against HPV-31 / 33/45 for two-dose women who received their second dose at 6 months ( 681 % , 270-870 ; CVT data only ) , but not those receiving it at one month ( 101 % , -420 to 433 ) , was similar to the three-dose group .
CONCLUSIONS	4 years after vaccination of women aged 15-25 years , one and two doses of the HPV-16 / 18 vaccine seem to protect against cervical HPV-16 / 18 infections , similar to the protection provided by the three-dose schedule .
CONCLUSIONS	Two doses separated by 6 months additionally provided some cross-protection .
CONCLUSIONS	These data argue for a direct assessment of one-dose efficacy of the HPV-16 / 18 vaccine .
BACKGROUND	US National Cancer Institute , National Institutes of Health Office of Research on Women 's Health , and Ministry of Health of Costa Rica ( CVT ) ; GlaxoSmithKline Biologicals SA ( PATRICIA ) .

###24485216
BACKGROUND	In postmenopausal women , yearly intravenous zoledronate ( ZOL ) compared to placebo ( PLB ) significantly increased bone mineral density ( BMD ) at lumbar spine ( LS ) , femoral neck ( FN ) , and total hip ( TH ) and decreased fracture risk .
BACKGROUND	The effects of ZOL on BMD at the tibial epiphysis ( T-EPI ) and diaphysis ( T-DIA ) are unknown .
METHODS	A randomized controlled ancillary study of the HORIZON trial was conducted at the Department of Osteoporosis of the University Hospital of Berne , Switzerland .
METHODS	Women with 1 follow-up DXA measurement who had received 1 dose of either ZOL ( n = 55 ) or PLB ( n = 55 ) were included .
METHODS	BMD was measured at LS , FN , TH , T-EPI , and T-DIA at baseline , 6 , 12 , 24 , and 36 months .
METHODS	Morphometric vertebral fractures were assessed .
METHODS	Incident clinical fractures were recorded as adverse events .
RESULTS	Baseline characteristics were comparable with those in HORIZON and between groups .
RESULTS	After 36 months , BMD was significantly higher in women treated with ZOL vs. PLB at LS , FN , TH , and T-EPI ( +7.6 % , +3.7 % , +5.6 % , and +5.5 % , respectively , p < 0.01 for all ) but not T-DIA ( +1.1 % ) .
RESULTS	The number of patients with 1 incident non-vertebral or morphometric fracture did not differ between groups ( 9 ZOL/11 PLB ) .
RESULTS	Mean changes in BMD did not differ between groups with and without incident fracture , except that women with an incident non-vertebral fracture had significantly higher bone loss at predominantly cortical T-DIA ( p = 0.005 ) .
CONCLUSIONS	ZOL was significantly superior to PLB at T-EPI but not at T-DIA .
CONCLUSIONS	Women with an incident non-vertebral fracture experienced bone loss at T-DIA .

###25876341
OBJECTIVE	To compare the efficacy on vertebrobasilar insufficiency ( VBI ) between auricular acupuncture therapy and oral administration of medicine .
METHODS	Sixty patients of VBI were randomized into an auricular acupuncture therapy group and a medicine group , 30 cases in each one .
METHODS	In the auricular acupuncture group , acupuncture was applied bilaterally to gan ( CO12 ) and jiejie ( HX8 ) on the ears and needles were retained for 15 min .
METHODS	After needle withdrawal , the vaccariae semen were fixed with plaster at naogan ( AT3 , 4i ) , zhen ( AT3 ) , jing ( AH12 ) , shen ( CO10 ) and pi ( CO13 ) on the ears .
METHODS	In the medicine group , flunarizine hydrochloride capsules ( Sibelium ) , 5mg were prescribed for oral administration , once every night .
METHODS	The treatment lasted continuously for 2 weeks ( 14 days ) in the two groups .
METHODS	In 2 weeks , the clinical efficacy was assessed and the transcranial doppler ( TCD ) examination was performed .
RESULTS	After treatment , the symptom scores were all apparently reduced in the patients of the two groups ( P < 0.01 , P < 0.05 ) .
RESULTS	Compared with the medicine group , the reduced score was much more obvious in the auricular acupuncture group ( P < 0.05 ) , indicating the significant difference .
RESULTS	After treatment , with TCD examination , the blood velocity was increased to different degrees in the patients of low velocity type in the auricular acupuncture group and the medicine group ; that was reduced to different degrees in the patients of high velocity type in the auricular acupuncture group and the medicine group .
RESULTS	All of them were different significantly as compared with those before treatment ( all P < 0.05 ) .
RESULTS	But the difference was not significant between the two groups ( both P > 0.05 ) .
RESULTS	In comparison of clinical efficacy between the two groups , the effective rate was 93.3 % ( 28/30 ) in the acupuncture group and better than 76.7 % ( 23/30 ) in the medicine group , indicating the significant difference in comparison ( P < 0.05 ) .
CONCLUSIONS	The auricular acupuncture therapy achieves the definite efficacy on VBI and the efficacy is better than flunarizine hydrochloride capsules .

###25091662
BACKGROUND	Post licensure studies have identified an increased risk of intussusception following vaccination with currently licensed rotavirus vaccines , raising safety concerns generic to all rotavirus vaccines .
BACKGROUND	We describe the surveillance for intussusception in a phase III clinical trial with an oral monovalent rotavirus vaccine developed from the neonatal 116E strain .
METHODS	Using broad screening criteria and active surveillance , the incidence of intussusception between 6 weeks and 2 years of age was measured in 4532 children who received three doses of vaccine and 2267 children who received a placebo in the clinical trial .
METHODS	Possible intussusceptions were evaluated with a screening ultrasonogram .
METHODS	An independent intussusception case adjudication committee reviewed all intussusceptions and graded them on Brighton Collaboration criteria for diagnostic certainty .
RESULTS	We identified twenty-three intussusceptions on ultrasound from 1361 evaluated sentinel events .
RESULTS	Eleven were of level 1 diagnostic certainty as determined by the independent intussusception case adjudication committee .
RESULTS	None required surgical intervention , and the earliest identified intussusception was at 36 days following the third dose in a placebo recipient .
RESULTS	Among vaccine recipients the first event of intussusception occurred 112 days after the third dose .
RESULTS	The incidence of ultrasound-diagnosed intussusception was 200/100 ,000 child-years ( 95 % CI , 120 , 320 ) among those receiving the vaccine and 141/100 ,000 child-years ( 95 % CI , 50 , 310 ) among those receiving the placebo .
RESULTS	The incidence rate of confirmed intussusception among vaccine recipients was 94/100 ,000 child-years ( 95 % CI , 41 , 185 ) and 71/100 ,000 child-years ( 95 % CI , 15 , 206 ) among those receiving the placebo .
CONCLUSIONS	In this licensure study , 23 cases of intussusception were identified through an active surveillance system , but there was no temporal association with rotavirus vaccination .
CONCLUSIONS	The use of active surveillance with broad criteria intended for ensuring safety of children participating in a trial , identified several transient intussusceptions that were of doubtful clinical significance .

###25348087
BACKGROUND	Intra-peritoneal adhesions are frequent following abdominal surgery and are the most common cause of small bowel obstructions .
BACKGROUND	A hyaluronic acid/carboxymethylcellulose ( HA/CMC ) film adhesion barrier has been shown to reduce adhesion formation in abdominal surgery .
BACKGROUND	An HA/CMC powder formulation was developed for application during laparoscopic procedures .
METHODS	This was an exploratory , prospective , randomised , single-blind , parallel-group , Phase IIIb , multicentre study conducted at 15 hospitals in France to assess the safety of HA/CMC powder versus no adhesion barrier following laparoscopic colorectal surgery .
METHODS	Subjects 18 years of age who were scheduled for colorectal laparoscopy ( Mangram contamination class IIII ) within 8 weeks of selection were eligible , regardless of aetiology .
METHODS	Participants were randomised 1:1 to the HA/CMC powder or no adhesion barrier group using a centralised randomisation list .
METHODS	Patients assigned to HA/CMC powder received a single application of 1 to 10 g on adhesion-prone areas .
METHODS	In the no adhesion barrier group , no adhesion barrier or placebo was applied .
METHODS	The primary safety assessments were the incidence of adverse events , serious adverse events , and surgical site infections ( SSIs ) for 30 days following surgery .
METHODS	Between-group comparisons were made using Fisher 's exact test .
RESULTS	Of those randomised to the HA/CMC powder ( n = 105 ) or no adhesion barrier ( n = 104 ) groups , one patient in each group discontinued prior to the study end ( one death in each group ) .
RESULTS	Adverse events were more frequent in the HA/CMC powder group versus the no adhesion barrier group ( 63 % vs. 39 % ; P < 0.001 ) , as were serious adverse events ( 28 % vs. 11 % ; P < 0.001 ) .
RESULTS	There were no statistically significant differences between the HA/CMC powder group and the no adhesion barrier group in SSIs ( 21 % vs. 14 % ; P = 0.216 ) and serious SSIs ( 12 % vs. 9 % ; P = 0.38 ) , or in the most frequent serious SSIs of pelvic abscess ( 5 % and 2 % ; significance not tested ) , anastomotic fistula ( 3 % and 4 % ) , and peritonitis ( 2 % and 3 % ) .
CONCLUSIONS	This exploratory study found significantly higher rates of adverse events and serious adverse events in the HA/CMC powder group compared with the no adhesion barrier group in laparoscopic colorectal resection .
BACKGROUND	ClinicalTrials.gov NCT00813397 .
BACKGROUND	Registered 19 December 2008 .

###24798767
BACKGROUND	We conducted this study to assess the immunologic effect of daily 20 mg zinc supplementation for 24 weeks in HIV-infected children older than 6 months receiving highly active antiretroviral therapy ( ART ) .
METHODS	Fifty-two HIV-infected children older than 6 months in whom ART was initiated were randomized to receive either 20 mg of zinc or placebo for a period of 24 weeks .
METHODS	Children underwent clinical examination , anthropometry , and laboratory evaluations : CD4 % and count , viral load , and serum zinc level at baseline , 12 weeks , and 24 weeks .
METHODS	The primary outcome evaluated was CD4 % value at the end of 12 and 24 weeks of study intervention in the enrolled children .
RESULTS	Of 52 children enrolled , 49 completed the study .
RESULTS	The median CD4 % value rose from 10 % to 23 % at 12 weeks and to 24.5 % at 24 weeks in the zinc group , whereas in the placebo group , the value rose from 11 % to 20 % at 12 weeks and to 22 % at 24 weeks ( P = 0.188 for comparison between the zinc and the placebo group at 12 wk and P = 0.3 for comparison at 24 wk ) .
RESULTS	The median ( interquartile range ) log reductions in the viral load at 12 weeks in the 2 arms were similar at 12 ( P = 0.84 ) and 24 weeks ( P = 0.43 ) .
CONCLUSIONS	Supplementation of 20 mg zinc daily for 24 weeks did not have any statistically significant effect on the increase in CD4 % , decrease in viral load , anthropometric indices , and morbidity profile in HIV-infected children started on ART .

###24656700
OBJECTIVE	To investigate the effects of 4-month treatment of medroxyprogesterone acetate ( MPA ) and Diane-35 on the clinical and biochemical features of hyperandrogenism and quality of life of adolescent girls with polycystic ovarian syndrome ( PCOS ) .
METHODS	A prospective , randomized , cross-over study .
METHODS	An accredited pediatric and adolescent gynecology clinic of a university-affiliated tertiary hospital .
METHODS	76 adolescents girls aged 14 to 19 years old with PCOS were recruited from July 2007 to July 2010 .
METHODS	Girls were randomized into 2 groups .
METHODS	Group 1 received oral MPA for 4 months , followed by a washout period of 4 months , and then Diane-35 for another 4 months .
METHODS	Group 2 received the same combination but in the reverse order .
METHODS	Clinical and biochemical features of hyperandrogenism and quality of life were assessed .
RESULTS	There was no significant difference between the 2 groups at baseline .
RESULTS	No significant difference was found in the clinical and biochemical parameters of hyperandrogenism before and after treatment with MPA .
RESULTS	Significant reduction of the acne score , LH/FSH ratio , and testosterone level was seen after taking Diane-35 .
RESULTS	Hirsutism was also improved but it did not reach statistical significant .
RESULTS	When comparing post-MPA and post-Diane-35 , the post-Diane-35 group had significantly improved acne score and LH/FSH ratio .
RESULTS	No significant difference was found on quality of life between both groups after treatment .
CONCLUSIONS	Diane-35 may be a more suitable treatment option in adolescent girls diagnosed with PCOS when compared to MPA .

###25083776
OBJECTIVE	The purpose of this work was to evaluate the effect of loteprednol etabonate ( LE ) before the initiation of topical cyclosporine A ( tCsA ) therapy in patients with mild-to-moderate dry eye disease .
OBJECTIVE	Prospective , multicenter randomized double-masked parallel group clinical study ( NCT00407043 ) .
METHODS	Hundred and eighteen patients with dry eye disease were randomized to receive either LE and tCsA ( n = 61 ) or artificial tears ( AT ) and tCsA ( n = 57 ) .
METHODS	Hundred and twelve patients completed the study ( LE : n = 57 , AT : n = 55 ) and are included in the data analysis .
METHODS	Patients self-administered either LE or AT for 2 weeks 4 times per day , followed by tCsA twice per day accompanied by either LE twice per day or AT twice per day for an additional 6 weeks of treatment .
METHODS	Primary outcome measures included the Ocular Surface Disease Index ( OSDI ) questionnaire , the Likert scale using standardized facial expressions , lissamine green staining , fluorescein staining , and the Schirmer test .
METHODS	Additional measures included global self-assessment , and safety outcomes included slitlamp examination , intraocular pressure , and assessment of visual acuity .
RESULTS	Loteprednol etabonate pretreatment significantly reduced tCsA stinging ( P < 0.05 ) .
RESULTS	Both groups showed significantly improved OSDI scores at the 14 - , 30 - , and 60-day visits .
RESULTS	Loteprednol etabonate showed significantly more OSDI improvement than AT .
RESULTS	Both pretreatment strategies improved global self-assessment scores , Schirmer test , fluorescein staining , lissamine staining , and adjunctive AT use .
RESULTS	Loteprednol etabonate showed superior improvement in Schirmer test , fluorescein staining , and lissamine staining .
RESULTS	Intraocular pressure did not increase in either group .
CONCLUSIONS	Loteprednol etabonate induction therapy 2 weeks before the initiation of long-term tCsA treatment for chronic dry eye disease provides more rapid relief of dry eye signs and symptoms with greater efficacy than tCsA and AT alone .

###25885323
BACKGROUND	The prevalence of obesity among children and adolescents has been rapidly rising in Mainland China in recent decades , both in urban and rural areas .
BACKGROUND	There is an urgent need to develop effective interventions to prevent childhood obesity .
BACKGROUND	Limited rigid data regarding children and adolescent overweight prevention in China are available .
BACKGROUND	A national random controlled school-based obesity intervention program was developed in the mainland of China .
METHODS	The study was designed as a national multi-centered cluster randomized controlled trial involving more than 70,000 children and adolescents aged 7-18 years from 7 provinces in China .
METHODS	In each center , about 12-16 primary and secondary schools , with totally at least 10000 participants were randomly selected ( Primary : Secondary = 1:1 ) .
METHODS	All of the selected schools were randomly allocated to either intervention or control group ( Intervention : Control = 1:1 ) .
METHODS	The multi-components school-based and family-involved scheme was conducted within the intervention group for 9month , while students in the control group followed their usual health practice .
METHODS	The intervention consisted of four components : a ) Create supportive school and family environment , b ) Health lifestyles education and related compulsory physical activities , c ) Instruct and promote school physical education , d ) Self-monitor obesity related behaviors .
METHODS	Four types of outcomes including anthropometric , behavioral , blood chemical and physical fitness were measured to assess the effectiveness of the intervention program .
CONCLUSIONS	This is the first and largest multi-centered school-based obesity intervention program with the consideration of geographical and social-demographic characteristics of the rapidly increased obesity prevalence of Chinese children and adolescent .
CONCLUSIONS	The intervention is based on Social Cognitive Theory and Social-Ecological Model of Health , and follows a stepwise approach guided by PRECEDE-PROCEED ( P-P ) Model and Intervention Map .
CONCLUSIONS	The results of and lesson learned from this study will help guide future school-based national childhood obesity prevention programs in Mainland China .
BACKGROUND	January 22 , 2015 ;
BACKGROUND	NCT02343588 .

###24962039
BACKGROUND	Our objective was to compare the effectiveness and safety of traditional Chinese moxibustion to that of sham moxibustion in patients with chronic knee osteoarthritis ( KOA ) pain .
METHODS	We conducted a randomized placebo-controlled trial involving 110 patients with KOA who met the inclusion criteria .
METHODS	These patients randomly received either active moxibustion ( n = 55 ) or sham moxibustion control ( n = 55 ) at acupoints Dubi ( ST 35 ) , extra-point Neixiyan ( EX-LE 4 ) , and an Ashi ( tender ) point three times a week for 6 weeks .
METHODS	Effects were evaluated with Western Ontario and McMaster Universities ' Osteoarthritis Index ( WOMAC VA 3.1 ) criteria at the end of the course of treatment and 3 , 12 , and 24 weeks after the initial treatment .
RESULTS	The WOMAC pain scores showed greater improvement in the active treatment group than in control at weeks 3 ( P = 0.012 ) , 6 ( P < 0.001 ) , 12 ( P = 0.002 ) , and 24 ( P = 0.002 ) as did WOMAC physical function scores of the active treatment group at week 3 ( P = 0.002 ) , 6 ( P = 0.015 ) , and 12 ( P < 0.001 ) but not 24 ( P = 0.058 ) .
RESULTS	Patients and practitioners were blinded successfully , and no significant adverse effects were found during the trial .
CONCLUSIONS	A 6-week course of moxibustion seems to relieve pain effectively and improve function in patients with KOA for up to 18 weeks after the end of treatment .
CONCLUSIONS	Moxibustion treatment appears to be safe , and the usefulness of the novel moxa device was validated .
BACKGROUND	Current controlled trial : ISRCTN68475405 .
BACKGROUND	Registered 4 April 2014 .

###25015615
OBJECTIVE	To compare the efficacy and safety of single ( tamsulosin ) and double dose ( tamsulosin + alfuzosin ) alpha-blocker therapy for treating catheterized patients with acute urinary retention ( AUR ) due to benign prostatic hyperplasia ( BPH ) .
METHODS	Seventy patients with AUR due to BPH were catheterized and randomized into two groups : the single dose group ( 0.4 mg tamsulosin , 35 patients ) and the double dose group ( 0.4 mg tamsulosin + 10 mg alfuzosin , 35 patients ) .
METHODS	The catheter was removed after 3 days , and the patients were put on trial without catheter ( TWOC ) .
RESULTS	Seventy males ( mean age , 71.2 years ) were randomly assigned to receive double or single dose alpha-blocker ( 35 patients per group ) .
RESULTS	The intent-to-treat population consisted of 70 males .
RESULTS	Twenty-seven individuals in the double dose group and 19 in the single dose group did not require re-catheterization on the day of the TWOC ( 77 % and 54 % , respectively ; P = .003 ) .
RESULTS	Success using free-flow variables was also higher in the males who received double dose alpha-blocker compared with single dose therapy ( 48 % vs. 40 % ; P = .017 ) .
CONCLUSIONS	TWOC was more successful in males treated with double dose alpha-blockers , and the subsequent need for re-catheterization was also reduced .
CONCLUSIONS	The side-effect profiles were similar in the single and double dose alpha-blocker groups and were consistent with the known pharmacology .
CONCLUSIONS	These results state that double dose alpha-blocker treatment can be recommended for treating males after catheterization for AUR , which may reduce the need for re-catheterization .

###24952057
OBJECTIVE	Vascular closure devices ( VCD ) have been introduced into clinical practice with the aim of increasing the procedural efficiency and clinical safety of coronary angiography .
OBJECTIVE	However , clinical studies comparing VCD and manual compression have yielded mixed results , and large randomised clinical trials comparing the two strategies are missing .
OBJECTIVE	Moreover , comparative efficacy studies between different VCD in routine clinical use are lacking .
RESULTS	The Instrumental Sealing of ARterial puncture site - CLOSURE device versus manual compression ( ISAR-CLOSURE ) trial is a prospective , randomised clinical trial designed to compare the outcomes associated with the use of VCD or manual compression to achieve femoral haemostasis .
RESULTS	The test hypothesis is that femoral haemostasis after coronary angiography achieved using VCD is not inferior to manual compression in terms of access-site-related vascular complications .
RESULTS	Patients undergoing coronary angiography via the common femoral artery will be randomised in a 1:1:1 fashion to receive FemoSeal VCD , EXOSEAL VCD or manual compression .
RESULTS	The primary endpoint is the incidence of the composite of arterial access-related complications ( haematoma 5 cm , pseudoaneurysm , arteriovenous fistula , access-site-related bleeding , acute ipsilateral leg ischaemia , the need for vascular surgical/interventional treatment or documented local infection ) at 30 days after randomisation .
RESULTS	According to power calculations based on non-inferiority hypothesis testing , enrolment of 4,500 patients is planned .
RESULTS	The trial is registered at www.clinicaltrials.gov ( study identifier : NCT01389375 ) .
CONCLUSIONS	The safety of VCD as compared to manual compression in patients undergoing transfemoral coronary angiography remains an issue of clinical equipoise .
CONCLUSIONS	The aim of the ISAR-CLOSURE trial is to assess whether femoral haemostasis achieved through the use of VCD is non-inferior to manual compression in terms of access-site-related vascular complications .

###25245307
OBJECTIVE	To investigate the effects of weight reduction on foot structure , gait , and dynamic plantar loading in obese adults .
METHODS	In a 3-month randomized-controlled trial , participants were randomized to receive either a weight loss intervention based on portion-controlled meals or a delayed-treatment control .
METHODS	41 adults ( 32 F , 9 M ) with a mean SD age of 56.2 4.7 years and a BMI of 35.9 4.2 kg/m ( 2 ) .
METHODS	Arch Height Index ( AHI ) , Malleolar Valgus Index ( MVI ) , spatial and temporal gait parameters , plantar peak pressure ( PP ) and weight were measured at baseline , 3 , and 6 months .
RESULTS	The intervention group experienced significantly greater weight loss than did the control group ( 5.9 4.0 kg versus 1.9 3.2 kg , p = 0.001 ) after 3 months .
RESULTS	There were no differences between the groups in anatomical foot structure or gait .
RESULTS	However , the treatment group showed a significantly reduced PP than the control group beneath the lateral arch and the metatarsals 4 ( all p values < .05 ) at 3 months .
RESULTS	The change in PP correlated significantly with the change in weight at the metatarsal 2 ( r = 0.57 , p = 0.0219 ) , metatarsal 3 ( r = 0.56 , p = 0.0064 ) and the medial arch ( r = 0.26 , p < 0.0001 ) at 6 months .
CONCLUSIONS	This was the first RCT designed to assess the effects of weight loss on foot structure , gait , and plantar loading in obese adults .
CONCLUSIONS	Even a modest weight loss significantly reduced the dynamic plantar loading in obese adults .
CONCLUSIONS	However , weight loss appeared to have no effects on foot structure and gait .

###25314641
OBJECTIVE	We sought to develop placental growth factor as a predictive pharmacodynamic biomarker for motesanib efficacy as first-line therapy in patients with advanced nonsquamous non-small-cell lung cancer .
METHODS	Placental growth factor was evaluated at baseline and study week 4 ( after 3 weeks treatment ) in an exploratory analysis of data from a randomized phase 2 study of motesanib 125 mg once daily plus carboplatin/paclitaxel and in a prespecified analysis of data from a randomized , double-blind phase 3 study of motesanib 125 mg once daily plus carboplatin/paclitaxel vs placebo plus carboplatin/paclitaxel ( MONET1 ) .
METHODS	Associations between fold-change from baseline in placental growth factor and overall survival were evaluated using Cox proportional hazards models .
RESULTS	In the phase 2 study , serum placental growth factor increased from baseline a mean 2.8-fold at study week 4 .
RESULTS	Patients with 2.2-fold change from baseline in placental growth factor ( n = 18 ) had significantly longer overall survival than those with < 2.2-fold change ( n = 19 ; 22.9 vs 7.9 months ; hazard ratio , 0.30 ; 95 % CI , 0.12-0 .74 ; P = 0.009 ) .
RESULTS	Consequently , placental growth factor was investigated as a pharmacodynamic biomarker in the phase 3 MONET1 study .
RESULTS	There was no association between log-transformed placental growth factor fold-change from baseline to week 4 ( continuous variable ) and overall survival ( hazard ratio , 0.98 ; 95 % CI , 0.79-1 .22 ; P = 0.868 ) .
RESULTS	MONET1 did not meet its primary endpoint of overall survival .
RESULTS	Likewise , median overall survival was similar among patients with 2.0-fold change in placental growth factor ( n = 229 ) compared with < 2.0-fold change ( n = 127 ; 14.8 vs 13.8 months ; hazard ratio , 0.88 ; 95 % CI , 0.67-1 .15 , P = 0.340 ) .
CONCLUSIONS	Our results illustrate the challenges of successfully translating phase 2 biomarker results into phase 3 studies .
BACKGROUND	ClinicalTrials.gov NCT00460317 , NCT00369070 .

###25567831
OBJECTIVE	The Epley particle repositioning maneuver ( PRM ) is an effective treatment for benign paroxysmal positional vertigo ( BPPV ) , the most common cause of peripheral vertigo in primary care settings .
OBJECTIVE	The goal of this study was to determine whether the use of an iPhone application ( DizzyFIX ; Clearwater Clinical Ltd , Ottawa , Ontario , Canada ) by medical students had a significant impact on the performance of the PRM .
METHODS	We recruited senior medical students who had previously been trained in the management of BPPV and asked them to perform the PRM on a healthy volunteer .
METHODS	One half of the students used a real iPhone application , whereas the others used a sham application .
METHODS	The PRM performance scores of the 2 groups were compared .
RESULTS	iPhone application users scored significantly higher on their PRM performance compared with controls ( P < .0001 ) and performed the PRM significantly more slowly ( P < .0001 ) .
CONCLUSIONS	Senior medical students performed a more correct PRM when assisted by the iPhone application .
CONCLUSIONS	This application represents a significant improvement from standard medical school training using written instructions .
CONCLUSIONS	Family physicians could also use this iPhone application for the quick and effective treatment of BPPV .

###24429536
BACKGROUND	Studies of zinc as an adjunct to treatment of severe pneumonia in children have shown mixed results , possibly because of poor information on zinc status and respiratory pathogens .
OBJECTIVE	We evaluated the effect of zinc given with standard antimicrobial treatment on the duration of respiratory signs in children with severe pneumonia .
OBJECTIVE	Zinc status and pathogens were assessed .
METHODS	Children aged 2-59 mo with severe pneumonia who were admitted to the main children 's hospital in Quito , Ecuador , were given standard antibiotics and randomly allocated to receive zinc supplements twice daily or a placebo .
METHODS	Measurements included anthropometric variables , breastfeeding , hemoglobin , plasma zinc , and common bacteria/viral respiratory pathogens .
METHODS	The primary outcome was time to resolution of respiratory signs .
METHODS	The secondary outcome was treatment failure .
RESULTS	We enrolled 225 children in each group .
RESULTS	There was no difference between groups in time to resolution of respiratory signs or treatment failure ; pathogens were not associated with outcomes .
RESULTS	Tachypnea and hypoxemia resolved faster in older children ( P = 0.0001 ) than in younger ones .
RESULTS	Higher basal zinc concentration ( P = 0.011 ) and better height-for-age z score ( HAZ ) ( P = 0.044 ) were associated with faster resolution of chest indrawing .
RESULTS	Better weight-for-height z score ( WHZ ) ( P = 0.031 ) and HAZ ( P = 0.048 ) were associated with faster resolution of tachypnea .
RESULTS	Increased C-reactive protein was associated with a longer duration of tachypnea ( P = 0.044 ) .
CONCLUSIONS	Zinc did not affect time to pneumonia resolution or treatment failure , nor did type of respiratory pathogens affect outcomes .
CONCLUSIONS	Higher basal zinc and better HAZ and WHZ were associated with reduced time to resolution of respiratory signs .
CONCLUSIONS	These results suggest the need for prevention of chronic zinc deficiency and improvement of general nutritional status among Ecuadorian children .

###24655469
BACKGROUND	Perioperative red blood cell transfusion is associated with adverse outcomes after cardiac operations .
BACKGROUND	Although restrictive transfusion protocols have been developed , their safety and efficacy are not well demonstrated , and considerable variation in transfusion practice persists .
BACKGROUND	We report our experience with a restrictive transfusion protocol .
METHODS	We analyzed the outcomes in 409 patients undergoing cardiac operations enrolled in a trial conducted at 30 centers worldwide .
METHODS	Blood products were administered on the basis of a transfusion algorithm applied across all centers , with a restrictive transfusion trigger of hemoglobin less than or equal to 6 g/dL .
METHODS	Transfusion was acceptable but not mandatory for hemoglobin 6 to 8 g/dL .
METHODS	For hemoglobin 8 to 10 g/dL , transfusion was acceptable only with evidence for end-organ ischemia .
RESULTS	The patient population was moderately complex , with 20.5 % having combined procedures and 29.6 % having nonelective operations .
RESULTS	The mean EuroSCORE for the population was 4.3 , which predicted a substantial incidence of morbidity and mortality .
RESULTS	Actual outcomes were excellent , with observed mortality of 0.49 % and rates of cerebrovascular accident , myocardial infarction , and acute renal failure 1.2 % , 6.1 % , and 0.98 % , respectively .
RESULTS	The frequency of red blood cell transfusion was 33.7 % , which varied significantly by center .
RESULTS	Most transfusions ( 71.9 % ) were administered for hemoglobin 6 to 8g/dL ; 21.4 % were administered for hemoglobin 8 to 10g/dL with evidence for end-organ ischemia ; 65.0 % of patients avoided allogeneic transfusion altogether .
CONCLUSIONS	A restrictive transfusion protocol can be safely applied in the care of moderate-risk patients undergoing cardiac operations .
CONCLUSIONS	This strategy has significant potential to reduce transfusion and resource utilization in these patients , standardize transfusion practices across institutions , and increase the safety of cardiac operations .

###25218667
OBJECTIVE	Little is known about how weight loss affects magnetic resonance imaging ( MRI ) of liver fat and volume or liver histology in patients with nonalcoholic steatohepatitis ( NASH ) .
OBJECTIVE	We measured changes in liver fat and liver volume associated with weight loss by using an advanced MRI method .
METHODS	We analyzed data collected from a previous randomized controlled trial in which 43 adult patients with biopsy-proven NASH underwent clinical evaluation , biochemical tests , and MRI and liver biopsy analyses at the start of the study and after 24 weeks .
METHODS	We compared data between patients who did and did not have at least 5 % decrease in body mass index ( BMI ) during the study period .
RESULTS	Ten of 43 patients had at least a 5 % decrease in BMI during the study period .
RESULTS	These patients had a significant decrease in liver fat , which was based on MRI proton density fat fraction estimates ( 18.3 % 7.6 % to 13.6 % 13.6 % , P = .03 ) , a relative 25.5 % reduction .
RESULTS	They also had a significant decrease in liver volume ( 5.3 % ) .
RESULTS	However , no significant changes in levels of alanine aminotransferase or aspartate aminotransferase were observed with weight loss .
RESULTS	Thirty-three patients without at least 5 % decrease in BMI had insignificant increases in estimated liver fat fraction and liver volume .
CONCLUSIONS	A reduction in BMI of at least 5 % is associated with significant decrease in liver fat and volume in patients with biopsy-proven NASH .
CONCLUSIONS	These data should be considered in assessing effect size in studies of patients with nonalcoholic fatty liver disease or obesity that use MRI-estimated liver fat and volume as end points .

###24414607
BACKGROUND	There are no robust guidelines on strategies to prevent the adverse skeletal effects of glucocorticoids in children .
OBJECTIVE	To evaluate the role of prophylactic calcium and vitamin D on bone health in children with new-onset nephrotic syndrome ( NS ) treated with short-term ( 12weeks ) , high-dose glucocorticoids .
METHODS	Prospective , randomized , controlled , single blind , interventional study conducted on 41 steroid-nave pre-pubertal children ( 29 boys , 12 girls ) .
METHODS	All children received prednisolone for 12weeks ( 60mg/m ( 2 ) / day daily for 6weeks , followed by 40mg/m ( 2 ) / day alternate days for 6weeks ) .
METHODS	Recruited children were randomized into the intervention group ( IG ; vitamin D 1,000 IU/day and elemental calcium 500mg/day ) and the control group ( CG ) .
METHODS	Bone mineral content ( BMC ) and bone mineral density ( BMD ) at the lumbar spine ( L1-L4 ) were estimated at baseline and at 12weeks .
METHODS	Mean percentage changes in BMC and BMD in IG and CG were compared .
RESULTS	Children in the IG showed an increase of 11.2 % in BMC versus the CG , who showed an 8.9 % fall ( p < 0.0001 ) .
RESULTS	Net intervention-attributable difference in BMC was 20.1 % .
RESULTS	BMD increased in both groups ( IG 2.8 % vs CG 0.74 % ) , but the difference was not statistically significant ( p = 0.27 ) .
CONCLUSIONS	Short-term , high-dose glucocorticoid therapy decreases the BMC of the lumbar spine in steroid-nave children with NS .
CONCLUSIONS	Vitamin D and calcium co-administration not only prevents this decline , but also enhances BMC of the lumbar spine .

###24568487
OBJECTIVE	To observe the short-term efficacy , long-term survival time and adverse responses with nedaplatin ( NDP ) or cisplatin ( DDP ) concomitant with other chemotherapy in treating non-small cell lung cancer .
METHODS	A retrospective , randomized , control study was conducted , in which 619 NSCLC patients in phases III and IV who were initially treated and re-treated were randomly divided into an NDP group ( n = 294 ) and a DDP group ( n = 325 ) , the latter being regarded as controls .
METHODS	Chemotherapeutic protocols ( CP/DP/GP / NP/TP ) containing NDP or DDP were given to both groups .
METHODS	Patients in both groups were further divided to evaluate the clinical efficacies according to initial and re-treatment stage , pathological pattern , type of combined chemotherapeutic protocols , tumor stage and surgery .
RESULTS	The overall response rate ( ORR ) and disease control rate ( DCR ) in the NDP group were 48.6 % and 95.2 % , significantly higher than in the DDP group at 35.1 % and 89.2 % , respectively ( P < 0.01 ) .
RESULTS	In NSCLC patients with initial treatment , squamous carcinoma and phase III , there were significant differences in ORR and DCR between the groups ( P < 0.05 ) , while ORR was significant in patients with adenocarcinoma , GP/TP and in phase IIIa ( P < 0.05 ) .
RESULTS	There was also a significant difference in DCR in patients in phase IIIb ( P < 0.05 ) .
RESULTS	According to the statistical analysis of survival time of all patients and of those in clinical phase III , the NDP group survived significantly longer than the DDP group ( P < 0.01 ) .
RESULTS	The rates of decreased hemoglobin and increased creatinine , nausea and vomiting in the NDP group were evidently lower than in DDP group ( P < 0.05 ) .
CONCLUSIONS	NDP concomitant with other chemotherapy is effective for treating NSCLC , with higher clinical efficacy than DDP concomitant with chemotherapy , with advantages in prolonging survival time and reducing toxic and adverse responses .

###24229826
BACKGROUND	Electronic monitoring of inhaled asthma medications is one method to measure medication adherence and patterns of use .
BACKGROUND	Information on the performance of monitors in a randomized controlled trial allows researchers and clinicians to understand their utility and limitations .
BACKGROUND	The Smartinhaler Tracker is an electronic monitor for metered-dose inhalers ( MDIs ) that records the date , time , and number of actuations .
OBJECTIVE	To determine the performance of the Smartinhaler monitors used in a 24-week randomized controlled trial of 303 patients with asthma in a real-world setting .
METHODS	Prestudy use checks involved 2 actuations of the MDI , with a further 2 performed 2 hours later .
METHODS	Within-study monitor checks , performed before dispensing at clinic visits 2 to 4 , included a computerized check of monitor clock function , actuation accuracy , and battery life .
METHODS	Within-study data checks involved computerized checks of monitor clock function before data upload .
RESULTS	Two thousand six hundred seventy-eight of 2728 monitors ( 98.2 % ) passed prestudy use checks .
RESULTS	Seventy-six of 2642 monitors ( 2.9 % ) dispensed to participants failed within-study monitor checks .
RESULTS	Fifty-one of 2642 monitors ( 1.9 % ) malfunctioned before data upload , mostly as a result of fluid immersion .
RESULTS	Ninety-three of 2642 monitors ( 3.5 % ) were lost or thrown away by participants .
RESULTS	Complete data was available from 2498 of 2642 dispensed monitors ( 94.5 % ) and 2498 of 2549 returned monitors ( 98.0 % ) .
CONCLUSIONS	The Smartinhaler Tracker is a reliable monitor for measuring MDI use in a real-world setting .
CONCLUSIONS	Use of extensive monitor and data-checking protocols reduces data loss .
CONCLUSIONS	In a research or clinical setting , the use of a validated and reliable electronic monitor represents the reference standard for assessing patterns of medication use .

###24582373
BACKGROUND	Cutaneous discomfort is typically reported during transcranial direct current stimulation ( tDCS ) , restricting the current intensity and duration at which tDCS can be applied .
BACKGROUND	It is commonly thought that current density is associated with the intensity of perceived cutaneous perception such that larger electrodes with a lower current density results in milder cutaneous sensations .
OBJECTIVE	The present study examined the relationship between current density , current intensity and cutaneous sensations perceived during tDCS .
METHODS	Two experiments were performed .
METHODS	In the first control experiment , the cutaneous sensations induced by varying current intensities ( 0.025 , 0.5 , 1.0 and 1.5 mA ) were examined up to 10 min .
METHODS	These data were used for optimizing inter-stimulation intervals in the second main experiment , where participants rated the intensity , spatial size and location of the cutaneous sensations experienced during tDCS using two electrodes sizes ( 16 cm2 and 35 cm2 ) .
METHODS	In the equivalent current density condition , the current density was kept constant under both electrodes ( 0.014 , 0.029 and 0.043 mA/cm2 ) , whereas in the equal current intensity condition ( 0.5 , 1.0 and 1.5 mA ) the same intensities were used for the two electrode sizes .
RESULTS	Large electrodes were associated with greater cutaneous discomfort when compared to smaller electrodes at a given current density .
RESULTS	Further , levels of cutaneous perception were similar for small and large electrodes when current intensity was kept constant .
CONCLUSIONS	Cutaneous sensations during stimulation can be minimized by reducing the electrode size from 35 cm2 to 16 cm2 .

###25245489
OBJECTIVE	We compared the efficacy and safety of the currently recommended dose of pentosan polysulfate sodium with a third of the daily dose and with placebo .
METHODS	In this multicenter , double-blind , randomized , placebo controlled study 368 adults with interstitial cystitis/bladder pain syndrome , defined as an ICSI total score of 8 or greater and a score of greater than 0 on the 4 ICSI component items , received pentosan polysulfate sodium 100 mg once daily or 3 times daily , or matching placebo for 24 weeks .
METHODS	Study eligibility was not based on cystoscopy findings .
METHODS	ICSI was administered at baseline , and at weeks 4 , 8 , 12 , 18 and 24 .
METHODS	Unblinded interim analysis performed at 6 years with 54 % of the target number of 645 patients enrolled resulted in early study termination .
RESULTS	There was no statistically significant difference between the pentosan polysulfate sodium group and the placebo group or between the 2 pentosan polysulfate sodium groups for the primary end point , defined as responder achieving a 30 % or greater reduction from the baseline ICSI total score at study end .
RESULTS	This primary end point was achieved by 48 of 118 patients ( 40.7 % ) in the placebo group , and by 51 of 128 ( 39.8 % ) and 52 of 122 ( 42.6 % ) in the pentosan polysulfate sodium 100 mg once daily and 3 times daily groups , respectively .
RESULTS	Pentosan polysulfate sodium was well tolerated with a similar percent of patients ( range 10.2 % to 13.3 % ) across the groups discontinuing due to an adverse event .
CONCLUSIONS	Results of this study in a broad population of patients with symptoms consistent with interstitial cystitis revealed no treatment effect vs placebo for pentosan polysulfate sodium at the currently established dose or at a third of the daily dose .

###25066556
BACKGROUND	To date , no randomized study has investigated the value of optical coherence tomography ( OCT ) in optimizing the results of coronary angioplasty for non-ST-segment elevation acute coronary syndromes .
METHODS	DOCTORS is a randomized , prospective , multicenter , open-label clinical trial to evaluate the utility of OCT to optimize results of angioplasty of a lesion responsible for non-ST-elevation acute coronary syndromes .
METHODS	Patients ( n = 250 ) will be randomized to undergo OCT-guided angioplasty ( use of OCT to optimize procedural result , including change to strategy with the possibility of additional interventions ) or angioplasty under fluoroscopy alone .
METHODS	The primary end point is the functional result of the angioplasty procedure as assessed by fractional flow reserve ( FFR ) measured at the end of the procedure .
METHODS	Secondary end points include safety of OCT in the context of angioplasty for ACS , percentage of patients in whom OCT reveals suboptimal result of stenting , percentage of patients in whom a change in procedural strategy is decided based on OCT data , correlation between quantitative measures by OCT and FFR , determination of a threshold for quantitative OCT measure that best predicts FFR 0.90 , and identification of OCT variables that predict postprocedure FFR .
METHODS	Adverse cardiac events ( death , recurrent myocardial infarction , stent thrombosis , and repeat target lesion revascularization ) at 6 months will be recorded .
CONCLUSIONS	The DOCTORS randomized trial ( ClinicalTrials.gov NCT01743274 ) is designed to investigate whether use of OCT yields useful additional information beyond that obtained by angiography alone and , if so , whether this information changes physician strategy and impacts on the functional result of angioplasty as assessed by FFR .

###25554556
BACKGROUND	Disposable electrocardiographic lead wires ( ECG-LWs ) may not be as durable as reusable ones .
OBJECTIVE	To examine differences in alarm events between disposable and reusable ECG-LWs .
METHODS	Two cardiac telemetry units were randomized to reusable ECG-LWs , and 2 units alternated between disposable and reusable ECG-LWs for 4 months .
METHODS	A remote monitoring team , blinded to ECG-LW type , assessed frequency and type of alarm events by using total counts and rates per 100 patient days .
METHODS	Event rates were compared by using generalized linear mixed-effect models for differences and noninferiority between wire types .
RESULTS	In 1611 patients and 9385.5 patient days of ECG monitoring , patient characteristics were similar between groups .
RESULTS	Rates of alarms for no telemetry , leads fail , or leads off were lower in disposable ECG-LWs ( adjusted relative risk [ 95 % CI ] , 0.71 [ 0.53-0 .96 ] ; noninferiority P < .001 ; superiority P = .03 ) and monitoring ( artifact ) alarms were significantly noninferior ( adjusted relative risk [ 95 % CI ] : 0.88 , [ 0.62-1 .24 ] , P = .02 ; superiority P = .44 ) .
RESULTS	No between-group differences existed in false or true crisis alarms .
RESULTS	Disposable ECG-LWs were noninferior to reusable ECG-LWs for all false-alarm events ( N [ rate per 100 patient days ] , disposable 2029 [ 79.1 ] vs reusable 6673 [ 97.9 ] ; adjusted relative risk [ 95 % CI ] : 0.81 [ 0.63-1 .06 ] , P = .002 ; superiority P = .12 . )
CONCLUSIONS	Disposable ECG-LWs with patented push-button design had superior performance in reducing alarms created by no telemetry , leads fail , or leads off and significant noninferiority in all false-alarm rates compared with reusable ECG-LWs .
CONCLUSIONS	Fewer ECG alarms may save nurses time , decrease alarm fatigue , and improve patient safety .

###24706088
OBJECTIVE	Atrial tachyarrhythmias ( AT ) commonly recur within the first 3 months after radiofrequency catheter ablation ( RFCA ) of atrial fibrillation ( AF ) , and the influence of antiarrhythmic drugs ( AADs ) on the recurrences has not been fully elucidated .
OBJECTIVE	We sought to evaluate the efficacy of a 3-month lower-dose flecainide regime on early and late recurrences of ATs .
RESULTS	We randomly assigned 126 patients , who underwent RFCA for AF , to the flecainide group ( 150 or 100 mg/day according to their body weight ) or to the control group receiving no AADs .
RESULTS	The primary endpoint was any AT lasting for 30 s during the first 3 months and the secondary endpoint was a composite of ATs lasting for 24 h or requiring cardioversion or hospitalization during the same period .
RESULTS	All AADs were stopped after the first 3 months and the late arrhythmia recurrences were also evaluated .
RESULTS	The primary endpoint rates were 37 and 41 % in the flecainide ( 143 19 mg/day ) and control groups , respectively ( log-rank P = 0.76 ) , and those of the secondary endpoint were 10 and 14 % , respectively ( log-rank P = 0.45 ) .
RESULTS	The estimated rates of maintaining sinus rhythm at 12 months after the first 3 months were 78 and 72 % , in the flecainide and control groups , respectively ( log-rank P = 0.68 ) , and the rates were 51 and 90 % in those with and without the primary endpoint , respectively ( log-rank P < 0.001 ) .
CONCLUSIONS	The 3-month lower-dose flecainide therapy after AF ablation did not reduce the early and late arrhythmia recurrences .
CONCLUSIONS	The clinically significant ATs were also not prevented .

###25318784
BACKGROUND	Motor relearning protocols should involve task-oriented movement , focused attention , and repetition of desired movements .
OBJECTIVE	To investigate the effect of intensive gait training with rhythmic auditory stimulation on postural control and gait performance in individuals with chronic hemiparetic stroke .
METHODS	Twenty patients with chronic hemiparetic stroke participated in this study .
METHODS	Subjects in the Rhythmic auditory stimulation training group ( 10 subjects ) underwent intensive gait training with rhythmic auditory stimulation for a period of 6 weeks ( 30 min/day , five days/week ) , while those in the control group ( 10 subjects ) underwent intensive gait training for the same duration .
METHODS	Two clinical measures , Berg balance scale and stroke specific quality of life scale , and a 2-demensional gait analysis system , were used as outcome measure .
METHODS	To provide rhythmic auditory stimulation during gait training , the MIDI Cuebase musical instrument digital interface program and a KM Player version 3.3 was utilized for this study .
RESULTS	Intensive gait training with rhythmic auditory stimulation resulted in significant improvement in scores on the Berg balance scale , gait velocity , cadence , stride length and double support period in affected side , and stroke specific quality of life scale compared with the control group after training .
CONCLUSIONS	Findings of this study suggest that intensive gait training with rhythmic auditory stimulation improves balance and gait performance as well as quality of life , in individuals with chronic hemiparetic stroke .

###25000669
OBJECTIVE	To assess the dentin hypersensitivity-reducing effectiveness of a 0.454 % stannous-containing dentifrice as compared to a marketed negative control dentifrice after the first brushing as well as after 3 days and 2 weeks of twice daily use .
METHODS	This was a 2-week , randomized , double-blind , parallel group , single-center clinical investigation in confirmed dentin hypersensitivity adult sufferers .
METHODS	At baseline , subjects were stratified by age , gender , and thermal sensitivity scores , and randomly assigned to a marketed 0.454 % stannous fluoride ( SnF2 ) dentifrice or a marketed sodium fluoride ( NaF ) dentifrice negative control .
METHODS	Following baseline assessment of tactile and thermal sensitivity via the Yeaple Probe and air-blast/Schiff Air Index evaluations , respectively , subjects brushed once on-site with their assigned test product following the same usage instructions .
METHODS	Post-brushing tactile and thermal sensitivity were then assessed ( ` Immediate ' evaluation ) .
METHODS	Subjects subsequently brushed twice daily at home for a 2-week period , with the same tactile and thermal efficacy evaluations repeated at Day 3 and Week 2 post-baseline .
RESULTS	All 116 enrolled subjects completed all evaluations .
RESULTS	The stannous fluoride dentifrice provided significantly ( P < 0.0001 ) superior dentin hypersensitivity reduction compared to the negative control dentifrice at each time point and by both evaluation measures : superior mean relative Yeaple Probe ( tactile ) benefits were 124.5 % after one use , 203.8 % after 3 days , and 222.5 % after 2 weeks ; and superior mean relative Schiff Air Index ( thermal ) benefits were 27.6 % after a single use , 44.6 % at Day 3 , and 74.2 % at Week 2 .
RESULTS	Both dentifrices were well-tolerated .

###24767299
OBJECTIVE	To evaluate the efficacies of modified chitosan , an adhesive prevention substance , as a biological barrier for preventing adhesion after Cesarean section .
METHODS	A total of 250 cases undergoing primary Cesarean section from January 2011 to June 2012 at our hospital were recruited .
METHODS	They were randomly divided into experiment ( n = 130 ) and control ( n = 120 ) groups .
METHODS	The experiment group received modified chitosan during Cesarean section while no adhesive prevention substance was offered for the control group .
METHODS	Postoperative flatus time , postoperative infection and pelvic adhesion were used to evaluate the clinical efficacies .
RESULTS	For the experiment group , the average postoperative flatus time was ( 25 7 ) hours .
RESULTS	Three cases had postoperative infections with a postoperative infection rate of 2.3 % .
RESULTS	There were 2 cases of pelvic adhesion ( pelvic adhesion rate : 1.5 % ) during the postoperative follow-up period .
RESULTS	For the control group , the average postoperative flatus time was ( 34 11 ) hours .
RESULTS	Five cases had postoperative infections with a postoperative infection rate of 4.2 % .
RESULTS	There were 5 cases of pelvic adhesion ( pelvic adhesion rate : 4.2 % ) during the postoperative follow-up period .
RESULTS	There were significant inter-group differences in postoperative flatus time , postoperative infection and pelvic adhesion ( P < 0.05 ) .
CONCLUSIONS	Modified chitosan can prevent pelvic adhesion after Cesarean section .

###25014615
BACKGROUND	Baseline patients ' characteristics are critical for treatment planning , as these can be moderators of treatment effects .
BACKGROUND	In Mexico , information on treatment seekers with substance use disorders is scarce and limited to demographic characteristics .
OBJECTIVE	This paper presents and analyses demographic characteristics , substance use related problems , clinical features , and addiction severity in a sample of treatment seekers from the first multi-site randomized clinical trial implemented in the Mexican Clinical Trials Network on Addiction and Mental Health .
METHODS	A total of 120 participants were assessed prior randomization .
METHODS	Chi square or F-tests were used to compare sites across variables .
METHODS	Spearman correlation was used to associate negative consequences of substance use and motivation to change .
RESULTS	The majority of participants were men , and the most prevalent substances reported were alcohol , marijuana , and cocaine .
RESULTS	Participants were predominantly on the contemplation or action stage of change , and this was correlated with the perception of the negative consequences associated with substance use .
RESULTS	Participants reported a high prevalence of substance use related problems .
CONCLUSIONS	Substance use related problems , clinical features , and addiction severity reported by treatment seekers are important characteristics to take into account when planning treatment as they facilitate tailoring treatment to meet patients ' needs .

###24981585
BACKGROUND	The aim was to compare endovenous laser ablation ( EVLA ) and endovenous steam ablation ( EVSA ) for great saphenous varicose veins in a non-inferiority study .
METHODS	Patients with primary great saphenous vein reflux were randomized to EVLA ( 940nm ) or EVSA ( SVS ) .
METHODS	Primary outcomes were treatment success ( vein obliteration or abolition of reflux ) [ corrected ] at 52weeks , and Venous Clinical Severity Score ( VCSS ) at 12weeks .
METHODS	Secondary outcomes were pain , satisfaction with treatment , duration of analgesia use and days lost from daily activities , changes in Aberdeen Varicose Vein Questionnaire ( AVVQ ) and EQ-5D scores after 12weeks , and complications at 2 and 12weeks .
RESULTS	A total of 227 legs were treated ( EVSA , 117 ; EVLA , 110 ) ; 36 legs treated with EVSA received a low dose and the remaining 81 a higher dose .
RESULTS	At 1 year , the treatment success rate after high-dose EVSA was not inferior to that of EVLA : 92 ( 95 per cent confidence interval ( c.i. ) 86 to 98 ) versus 96 ( 92 to 100 ) per cent respectively .
RESULTS	Changes in VCSS after 12weeks were similar : -269 ( 95 per cent c.i. -234 to -304 ) and -251 ( -210 to -293 ) .
RESULTS	AVVQ , EQ-5D and EQ VAS scores improved equally 12weeks after both treatments .
RESULTS	Patients treated with EVSA reported less postprocedural pain , fewer days of analgesia use , were more satisfied with therapy , and had a shorter convalescence .
RESULTS	Complication rates were comparable .
CONCLUSIONS	The 1-year treatment success of high-dose EVSA was not inferior to that of EVLA .
CONCLUSIONS	Several secondary outcomes were in favour of EVSA .
CONCLUSIONS	Registration number NCT02046967 ( http://www.clinicaltrials.gov ) .

###25909333
BACKGROUND	Recommendations for surgical , compared with lifestyle and pharmacologically based , approaches for type 2 diabetes ( T2D ) management remain controversial .
OBJECTIVE	The objective was to compare laparoscopic adjustable gastric band ( LAGB ) to an intensive medical diabetes and weight management ( IMWM ) program for T2D .
METHODS	This was designed as a prospective , randomized clinical trial .
METHODS	The setting was two Harvard Medical School-affiliated academic institutions .
METHODS	INTERVENTIONS AND PARTICIPANTS : A 12-month randomized trial comparing LAGB ( n = 23 ) vs IMWM ( n = 22 ) in persons aged 21-65 years with body mass index of 30-45 kg/m ( 2 ) , T2D diagnosed more than 1 year earlier , and glycated hemoglobin ( HbA ( 1c ) ) 6.5 % on antihyperglycemic medication ( s ) .
METHODS	The proportion meeting the prespecified primary glycemic endpoint , defined as HbA ( 1c ) < 6.5 % and fasting glucose < 7.0 mmol/L at 12 months , on or off medication .
RESULTS	After randomization , five participants did not undergo the surgical intervention .
RESULTS	Of the 40 initiating intervention ( 22 males/18 females ; age , 51 10 y ; body mass index , 36.5 3.7 kg/m ( 2 ) ; diabetes duration , 9 5 y ; HbA ( 1c ) , 8.2 1.2 % ; 40 % on insulin ) , the proportion meeting the primary glycemic endpoint was achieved in 33 % of the LAGB patients and 23 % of the IMWM patients ( P = .457 ) .
RESULTS	HbA ( 1c ) reduction was similar between groups at both 3 and 12 months ( -1.2 0.3 vs -1.0 0.3 % ; P = .496 ) .
RESULTS	Weight loss was similar at 3 months but greater 12 months after LAGB ( -13.5 1.7 vs -8.5 1.6 kg ; P = .027 ) .
RESULTS	Systolic blood pressure reduction was greater after IMWM than LAGB , whereas changes in diastolic blood pressure , lipids , fitness , and cardiovascular risk scores were similar between groups .
RESULTS	Patient-reported health status , assessed using the Short Form-36 , Impact of Weight on Quality of Life , and Problem Areas in Diabetes , all improved similarly between groups .
CONCLUSIONS	LAGB and a multidisciplinary IMWM program have similar 1-year benefits on diabetes control , cardiometabolic risk , and patient satisfaction , which should be considered in the context of other factors , such as personal preference , when selecting treatment options with obese T2D patients .
CONCLUSIONS	Longer duration studies are important to understand emergent differences .

###24824660
OBJECTIVE	Autism spectrum disorders ( ASDs ) have core impairments in social communication as well as the presence of repetitive , stereotypic behaviors and restricted interests .
OBJECTIVE	Older adolescents and young adults are particularly impacted by these deficits .
OBJECTIVE	Preclinical data implicate glutamatergic dysfunction in the pathophysiology of ASDs .
OBJECTIVE	D-Cycloserine ( DCS ) , a partial glycineB agonist at the N-methyl-D-aspartic acid receptor site , has been shown to improve sociability in mouse models and a small human study .
OBJECTIVE	The sensitivity of the obligatory glycineB co-agonist binding site may change with daily administration of DCS as a result of agonist-induced desensitization .
OBJECTIVE	The efficacy of a `` pulsed '' once-weekly administration versus `` daily '' administration of DCS was compared .
METHODS	Males and females , ages 14 to 25 years , with a Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition Text Revision diagnosis of an ASD were enrolled in a double-blind , randomized 10-week trial consisting of 8 weeks of active drug with either weekly or daily administration of 50 mg of DCS followed by a 2-week follow-up visit .
RESULTS	For the purposes of this study , no statistical or clinical differences existed between the 2 dosage groups on the Aberrant Behavior Checklist subscale 3 , which measures stereotypies/repetitive movements .
RESULTS	When combining groups , a statistically significant decrease of 37 % was found from baseline to week 8 when study drug was completed using a linear mixed effects model ( P = 0.003 ) .
CONCLUSIONS	D-Cycloserine was shown to be effective in improving stereotypic symptoms in older adolescents and young adults with ASDs measured by the Aberrant Behavior Checklist subscale 3 .
CONCLUSIONS	In addition , DCS was safe and well tolerated .

###24929429
OBJECTIVE	We estimate the effect size of hypoglycemia risk reduction on closed-loop control ( CLC ) versus open-loop ( OL ) sensor-augmented insulin pump therapy in supervised outpatient setting .
METHODS	Twenty patients with type 1 diabetes initiated the study at the Universities of Virginia , Padova , and Montpellier and Sansum Diabetes Research Institute ; 18 completed the entire protocol .
METHODS	Each patient participated in two 40-h outpatient sessions , CLC versus OL , in randomized order .
METHODS	Sensor ( Dexcom G4 ) and insulin pump ( Tandem t : slim ) were connected to Diabetes Assistant ( DiAs ) - a smartphone artificial pancreas platform .
METHODS	The patient operated the system through the DiAs user interface during both CLC and OL ; study personnel supervised on site and monitored DiAs remotely .
METHODS	There were no dietary restrictions ; 45-min walks in town and restaurant dinners were included in both CLC and OL ; alcohol was permitted .
RESULTS	The primary outcome-reduction in risk for hypoglycemia as measured by the low blood glucose ( BG ) index ( LGBI ) - resulted in an effect size of 0.64 , P = 0.003 , with a twofold reduction of hypoglycemia requiring carbohydrate treatment : 1.2 vs. 2.4 episodes/session on CLC versus OL ( P = 0.02 ) .
RESULTS	This was accompanied by a slight decrease in percentage of time in the target range of 3.9-10 mmol/L ( 66.1 vs. 70.7 % ) and increase in mean BG ( 8.9 vs. 8.4 mmol/L ; P = 0.04 ) on CLC versus OL .
CONCLUSIONS	CLC running on a smartphone ( DiAs ) in outpatient conditions reduced hypoglycemia and hypoglycemia treatments when compared with sensor-augmented pump therapy .
CONCLUSIONS	This was accompanied by marginal increase in average glycemia resulting from a possible overemphasis on hypoglycemia safety .

###24845609
OBJECTIVE	Both corticosteroid and pentoxifylline reduce short-term mortality in severe alcoholic hepatitis .
OBJECTIVE	However , few studies have directly compared the efficacy of pentoxifylline and corticosteroid in patients with this condition .
METHODS	In this multicentre , open-labelled , randomised non-inferiority trial , we assigned 121 patients with severe alcoholic hepatitis ( Maddrey 's discriminant function 32 ) to receive either pentoxifylline ( 400 mg , 3 times daily , in 62 subjects ) or prednisolone ( 40 mg daily , in 59 subjects ) .
METHODS	The primary end point was non-inferiority in survival at the 1 month time point for the pentoxifylline treatment compared with prednisolone .
RESULTS	The 1-month survival rate of patients receiving pentoxifylline was 75.8 % ( 15 deaths ) compared with 88.1 % ( 7 deaths ) in those , taking prednisolone , for a treatment difference of 12.3 % ( 95 % confidence interval , -4.2 % to 28.7 % ; p = 0.08 ) .
RESULTS	The 95 % confidence interval for the observed difference exceeded the predefined margin of non-inferiority ( 15 % ) and included zero .
RESULTS	The 6-month survival rate was not significantly different between the pentoxifylline and prednisolone groups ( 64.5 % vs. 72.9 % ; p = 0.23 ) .
RESULTS	At 7 days , the response to therapy assessed by the Lille model was significantly lower in the prednisolone group ( n = 58 ) than in the pentoxifylline group ( n = 5 9 ) : 0.35 vs. 0.50 ( p = 0.012 ) .
RESULTS	Hepatitis complications , including hepatorenal syndrome and side effects , such as infection and gastrointestinal bleeding , were similar in the two groups .
CONCLUSIONS	The findings demonstrate that the efficacy of the pentoxifylline is not statistically equivalent to the efficacy of prednisolone , supporting the use of prednisolone as a preferred treatment option in patients with severe alcoholic hepatitis .

###25117155
BACKGROUND	The potential for transmission of infectious diseases offered by the school environment are likely to be an important contributor to the rates of infectious disease experienced by children .
BACKGROUND	This study aimed to test whether the addition of hand sanitiser in primary school classrooms compared with usual hand hygiene would reduce illness absences in primary school children in New Zealand .
RESULTS	This parallel-group cluster randomised trial took place in 68 primary schools , where schools were allocated using restricted randomisation ( 1:1 ratio ) to the intervention or control group .
RESULTS	All children ( aged 5 to 11 y ) in attendance at participating schools received an in-class hand hygiene education session .
RESULTS	Schools in the intervention group were provided with alcohol-based hand sanitiser dispensers in classrooms for the winter school terms ( 27 April to 25 September 2009 ) .
RESULTS	Control schools received only the hand hygiene education session .
RESULTS	The primary outcome was the number of absence episodes due to any illness among 2,443 follow-up children whose caregivers were telephoned after each absence from school .
RESULTS	Secondary outcomes measured among follow-up children were the number of absence episodes due to specific illness ( respiratory or gastrointestinal ) , length of illness and illness absence episodes , and number of episodes where at least one other member of the household became ill subsequently ( child or adult ) .
RESULTS	We also examined whether provision of sanitiser was associated with experience of a skin reaction .
RESULTS	The number of absences for any reason and the length of the absence episode were measured in all primary school children enrolled at the schools .
RESULTS	Children , school administrative staff , and the school liaison research assistants were not blind to group allocation .
RESULTS	Outcome assessors of follow-up children were blind to group allocation .
RESULTS	Of the 1,301 and 1,142 follow-up children in the hand sanitiser and control groups , respectively , the rate of absence episodes due to illness per 100 child-days was similar ( 1.21 and 1.16 , respectively , incidence rate ratio 1.06 , 95 % CI 0.94 to 1.18 ) .
RESULTS	The provision of an alcohol-based hand sanitiser dispenser in classrooms was not effective in reducing rates of absence episodes due to respiratory or gastrointestinal illness , the length of illness or illness absence episodes , or the rate of subsequent infection for other members of the household in these children .
RESULTS	The percentage of children experiencing a skin reaction was similar ( 10.4 % hand sanitiser versus 10.3 % control , risk ratio 1.01 , 95 % CI 0.78 to 1.30 ) .
RESULTS	The rate or length of absence episodes for any reason measured for all children also did not differ between groups .
RESULTS	Limitations of the study include that the study was conducted during an influenza pandemic , with associated public health messaging about hand hygiene , which may have increased hand hygiene among all children and thereby reduced any additional effectiveness of sanitiser provision .
RESULTS	We did not quite achieve the planned sample size of 1,350 follow-up children per group , although we still obtained precise estimates of the intervention effects .
RESULTS	Also , it is possible that follow-up children were healthier than non-participating eligible children , with therefore less to gain from improved hand hygiene .
RESULTS	However , lack of effectiveness of hand sanitiser provision on the rate of absences among all children suggests that this may not be the explanation .
CONCLUSIONS	The provision of hand sanitiser in addition to usual hand hygiene in primary schools in New Zealand did not prevent disease of severity sufficient to cause school absence .
BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12609000478213 .
BACKGROUND	Please see later in the article for the Editors ' Summary .

###25119117
OBJECTIVE	To compare epidural analgesia ( EDA ) to patient-controlled opioid-based analgesia ( PCA ) in patients undergoing laparoscopic colorectal surgery .
BACKGROUND	EDA is mainstay of multimodal pain management within enhanced recovery pathways [ enhanced recovery after surgery ( ERAS ) ] .
BACKGROUND	For laparoscopic colorectal resections , the benefit of epidurals remains debated .
BACKGROUND	Some consider EDA as useful , whereas others perceive epidurals as unnecessary or even deleterious .
METHODS	A total of 128 patients undergoing elective laparoscopic colorectal resections were enrolled in a randomized clinical trial comparing EDA versus PCA .
METHODS	Primary end point was medical recovery .
METHODS	Overall complications , hospital stay , perioperative vasopressor requirements , and postoperative pain scores were secondary outcome measures .
METHODS	Analysis was performed according to the intention-to-treat principle .
RESULTS	Final analysis included 65 EDA patients and 57 PCA patients .
RESULTS	Both groups were similar regarding baseline characteristics .
RESULTS	Medical recovery required a median of 5 days ( interquartile range [ IQR ] , 3-7 .5 days ) in EDA patients and 4 days ( IQR , 3-6 days ) in the PCA group ( P = 0.082 ) .
RESULTS	PCA patients had significantly less overall complications [ 19 ( 33 % ) vs 35 ( 54 % ) ; P = 0.029 ] but a similar hospital stay [ 5 days ( IQR , 4-8 days ) vs 7 days ( IQR , 4.5-12 days ) ; P = 0.434 ] .
RESULTS	Significantly more EDA patients needed vasopressor treatment perioperatively ( 90 % vs 74 % , P = 0.018 ) , the day of surgery ( 27 % vs 4 % , P < 0.001 ) , and on postoperative day 1 ( 29 % vs 4 % , P < 0.001 ) , whereas no difference in postoperative pain scores was noted .
CONCLUSIONS	Epidurals seem to slow down recovery after laparoscopic colorectal resections without adding obvious benefits .
CONCLUSIONS	EDA can therefore not be recommended as part of ERAS pathways in laparoscopic colorectal surgery .

###26184556
BACKGROUND	To evaluate whether baseline acute and chronic prostate inflammation among men with initial negative biopsy for prostate cancer ( PC ) is associated with PC volume at the 2-year repeat prostate biopsy in a clinical trial with systematic biopsies .
METHODS	Retrospective analysis of 886 men with negative baseline prostate biopsy and positive 2-year repeat biopsy in the Reduction by Dutasteride of PC Events ( REDUCE ) study .
METHODS	Acute and chronic inflammation and tumor volume were determined by central pathology .
METHODS	The association of baseline inflammation with 2-year repeat biopsy cancer volume was evaluated with linear and Poisson regressions controlling for demographics and laboratory variables .
RESULTS	Chronic , acute inflammation , and both were detected in 531 ( 60 % ) , 12 ( 1 % ) , and 84 ( 9 % ) baseline biopsies , respectively .
RESULTS	Acute and chronic inflammation were significantly associated with each other ( P < 0.001 ) .
RESULTS	Chronic inflammation was associated with larger prostate ( P < 0.001 ) and lower pre-repeat biopsy PSA ( P = 0.01 ) .
RESULTS	At 2-year biopsy , baseline chronic inflammation was associated with lower mean tumor volume ( 2.07 l vs. 3.15 l ; P = 0.001 ) , number of biopsy cores involved ( 1.78 vs. 2.19 ; P < 0.001 ) , percent of cores involved ( 17.8 % vs. 22.8 % ; P < 0.001 ) , core involvement ( 0.21 l vs. 0.31 l ; P < 0.001 ) , and overall percent tumor involvement ( 1.40 % vs. 2.01 % ; P < 0.001 ) .
RESULTS	Results were unchanged in multivariable analysis .
RESULTS	Baseline acute inflammation was not associated with any tumor volume measurement .
CONCLUSIONS	In a cohort of men with 2-year repeat prostate biopsy positive for PC after a negative baseline biopsy , baseline chronic inflammation was associated with lower PC volume .

###24424409
BACKGROUND	To assess healthcare processes during treatment of neovascular age-related macular degeneration ( AMD ) in patients under real-life conditions and evaluate efficacy of monthly visual acuity ( VA ) assessment in a pro re nata treatment regime .
METHODS	A multicentre , prospective , non-interventional study based in Germany included neovascular AMD patients treated with intravitreal ranibizumab .
METHODS	Patients completed a 3-month loading phase with monthly intravitreal injections of 0.5 mg ranibizumab , followed by a 12-month maintenance phase during which investigators documented VA , additional injections , metamorphopsias , routine ophthalmological examinations and adverse events at monthly follow-up visits .
METHODS	Efficacy analysis included change from baseline in best-corrected VA ( BCVA ) based on descriptive statistics .
RESULTS	A total of 2,232 patients were enrolled throughout Germany and 1,729 patients ( mean age 77.8 years , 63.2 % women ) comprised the efficacy population with a complete set of data .
RESULTS	In the clinical setting recorded in our study , only a minority of patients underwent optical coherence tomography during the maintenance phase ( 71 of 1,729 patients ) .
RESULTS	Patients received a mean total of 4.5 injections ; three injections during upload phase and 1.5 additional injections during maintenance phase .
RESULTS	Over half of the patients ( 51.4 % ) did not receive additional injections .
RESULTS	Mean decimal BCVA increased during the upload phase , ( from LogMAR mean of 0.201 at baseline to 0.219 at Month 4 ) but displayed a decline over time ( 0.192 at Month 15 ) .
CONCLUSIONS	Ranibizumab treatment in a real-life setting demonstrated efficacy in neovascular AMD patients , as shown by initial gains in BCVA .
CONCLUSIONS	However , maintenance and improvement of these gains during the maintenance phase in a clinical routine setting remained below those expected compared with MARINA , ANCHOR and CATT trials , most likely due to a low number of retreatments , and the high number of patients with a poor response in regard to improvements of VA who were not investigated in these studies .
BACKGROUND	This phase IV non-interventional health services research study was conducted under the Novartis internal registration code , CRFB002ADE10 .

###24418950
OBJECTIVE	To assess whether a strategy of endovascular repair ( if aortic morphology is suitable , open repair if not ) versus open repair reduces early mortality for patients with suspected ruptured abdominal aortic aneurysm .
METHODS	Randomised controlled trial .
METHODS	30 vascular centres ( 29 UK , 1 Canadian ) , 2009-13 .
METHODS	613 eligible patients ( 480 men ) with a clinical diagnosis of ruptured aneurysm .
METHODS	316 patients were randomised to the endovascular strategy ( 275 confirmed ruptures , 174 anatomically suitable for endovascular repair ) and 297 to open repair ( 261 confirmed ruptures ) .
METHODS	30 day mortality , with 24 hour and in-hospital mortality , costs , and time and place of discharge as secondary outcomes .
RESULTS	30 day mortality was 35.4 % ( 112/316 ) in the endovascular strategy group and 37.4 % ( 111/297 ) in the open repair group : odds ratio 0.92 ( 95 % confidence interval 0.66 to 1.28 ; P = 0.62 ) ; odds ratio after adjustment for age , sex , and Hardman index 0.94 ( 0.67 to 1.33 ) .
RESULTS	Women may benefit more than men ( interaction test P = 0.02 ) from the endovascular strategy : odds ratio 0.44 ( 0.22 to 0.91 ) versus 1.18 ( 0.80 to 1.75 ) .
RESULTS	30 day mortality for patients with confirmed rupture was 36.4 % ( 100/275 ) in the endovascular strategy group and 40.6 % ( 106/261 ) in the open repair group ( P = 0.31 ) .
RESULTS	More patients in the endovascular strategy than in the open repair group were discharged directly to home ( 189/201 ( 94 % ) v 141/183 ( 77 % ) ; P < 0.001 ) .
RESULTS	Average 30 day costs were similar between the randomised groups , with an incremental cost saving for the endovascular strategy versus open repair of 1186 ( 1420 ; $ 1939 ) ( 95 % confidence interval -625 to 2997 ) .
CONCLUSIONS	A strategy of endovascular repair was not associated with significant reduction in either 30 day mortality or cost .
CONCLUSIONS	Longer term cost effectiveness evaluations are needed to assess the full effects of the endovascular strategy in both men and women .
BACKGROUND	Current Controlled Trials ISRCTN48334791 .

###24870737
OBJECTIVE	To observe the clinical efficacy of bevacizumab concomitant with pemetrexed in patients with advanced non-small cell lung cancer ( NSCLC ) .
METHODS	A total of 72 patients were randomly divided into a combination group ( pemetrexed + bevacizumab , n = 36 ) and a pemetrexed group ( n = 36 ) and assessed for disease control ( CR+PR+SD ) after 4-cycles of first-line GP chemotherapy ( gemcitabine + cisplatin ) .
METHODS	Clinical efficacy , progression-free survival time ( PFS ) , overall survival time ( OS ) , overall response rate ( ORR ) , disease control rate ( DCR ) and rate of adverse responses between two groups were observed and compared .
RESULTS	ORR and DCR were 27.8 % and 83.4 % in combination group , and 16.7 % and 69.5 % in the pemetrexed group , respectively , but there were no significant differences ( P > 0.05 ) .
RESULTS	PFS in combination group and pemetrexed group were 4.6 months and 3.9 months respectively ( P = 0.09 ) , whereas OS in the combination group was 14 months , evidently higher than in the pemetrexed group ( 11 months , P = 0.004 ) .
RESULTS	Adverse responses in both groups included high blood pressure , bleeding , thrombocytopenia , anemia , elevated transaminase , diarrhea , vomiting and proteinuria , but there were no significant differences ( P > 0.05 ) .
CONCLUSIONS	Bevacizumab concomitant with pemetrexed has better clinical efficacy and safety , giving rise to prolonged survival time in patients with advanced NSCLC .

###25906557
OBJECTIVE	To compare the differences in clinical efficacy on peripheral facial paralysis at acute stage between the opposing needling technique and routine acupuncture at the affected side so as to provide the evidence on the acupuncture treatment for peripheral facial paralysis at acute stage .
METHODS	Forty patients were rando - mized into an opposing needling technique group ( 19 cases ) and an affected side needling technique group ( 21 cases ) .
METHODS	The basic medication was same in the two groups .
METHODS	The acupoints were Fengchi ( GB 20 ) , Yangbai ( GB 14 ) to Yuyao ( EX-HN 4 ) ( penetrating needling method ) , Jingming ( BL 1 ) , Chengqi ( ST 1 ) , Xiaguan ( ST 7 ) , Jiache ( ST 6 ) to Dicang ( ST 4 ) , Hegu ( LI 4 ) and Zusanli ( ST 36 ) .
METHODS	In supplementation , in the opposing needling technique group , the acupoints were stimulated on the face of healthy side .
METHODS	In the affected side needling technique group , the acupoints were stimulated on the face of the affected side .
METHODS	The treatment was given three times a week , for 4 weeks .
METHODS	House-Brackmann ( H-B ) facial nerve function assessment was used to evaluate facial nerve function before and after treatment in the patients of the two groups .
METHODS	The efficacy was compared between the two groups .
RESULTS	The facial nerve function was recovered in the two groups and the total effective rate was 100.0 % in the two groups ( P > 0.05 ) .
RESULTS	The curative rate was 68.4 % ( 13/19 ) in the opposing needling technique group and better than 47.6 % ( 10/21 ) in the affected side needling technique group ( P < 0.05 ) .
RESULTS	On the 7th and 14th day , scores of H-B in the opposing needling technique group were better than those in the affected side needling technique group ( both P < 0.05 ) .
RESULTS	The curative time in the opposing needling technique group was apparently shorter than that in the affected side needling technique group ( ( 23.95 + / - 4.30 ) days vs. ( 29.14 + / - 5.43 ) days , P < 0.01 ) .
CONCLUSIONS	The opposing needling technique accelerates the recovery of facial nerve function in peripheral facial paralysis at acute stage and apparently shortens the curative time .
CONCLUSIONS	The efficacy is better than that in acupuncture on the affect - ed side of the face .

###25100236
OBJECTIVE	We used quantitative coronary angiography ( QCA ) to investigate whether coronary plaque progression can be inhibited by controlling lipids with rosuvastatin at Japanese standard doses following elective percutaneous coronary intervention ( PCI ) .
METHODS	A total of 143 patients who underwent elective PCI were randomized to either the rosuvastatin ( 5 or 2.5 mg/day ) or non-statin group .
METHODS	Changes from baseline in the minimal lumen diameter ( MLD ) and average lumen diameter ( ALD ) measured using QCA were analyzed in both target and non-target lesions .
RESULTS	The changes in MLD and ALD from baseline to 24 months in the non-target lesions were significantly smaller in the rosuvastatin group than in the non-statin group ( -0.079 0.014 mm vs.-0 .135 0.019 mm , p = 0.022 ; -0.062 0.012 mmvs .
RESULTS	-0.109 0.016 mm , p = 0.025 ) .
RESULTS	The changes in MLD from six to 24 months in the target lesions were significantly lower in the rosuvastatin group than in the non-statin group among the patients treated with drug-eluting stents ( -0.046 0.108 mm vs. -0.133 0.108 mm , p = 0.009 ) versus those treated with bare-metal stents ( -0.011 0.094 mm vs. -0.015 0.040 mm , p = 0.255 ) .
CONCLUSIONS	The present study demonstrated that the administration of a standard dose of rosuvastatin slows coronary plaque progression and may prevent the late catch-up phenomenon associated with drug-eluting stents in patients who undergo elective PCI .

###25237987
BACKGROUND	Naturally occurring gastrointestinal disease is an important cause of acute hypoproteinemia in adult horses and hydroxyethyl starch colloid fluid treatment is a component of supportive care in these cases to improve plasma volume and maintain colloid osmotic pressure ( COP ) .
BACKGROUND	The objectives of the present study were to compare 2 formulations of high molecular weight hydroxyethyl starch and their relative effect on COP , acid-base status , and survival of horses with acute hypoproteinemia secondary to gastrointestinal disease .
METHODS	Twenty adult horses , 1 year of age , were prospectively enrolled , with informed client consent , if they developed acute hypoproteinemia , defined as a plasma total protein < 5.0 g/dL or albumin < 2.2 g/dL during hospitalization while undergoing treatment for gastrointestinal disease .
METHODS	Horses were randomly assigned to receive a rapid infusion of either 6 % hydroxyethyl starch in 0.9 % saline or 6 % hydroxyethyl starch in lactated ringers solution at a dose of 10 ml/kg .
METHODS	Venous blood gas analysis , COP , and PCV were evaluated before and after colloid administration .
RESULTS	For both groups , average COP prior to treatment was 11.0 mmHg ( 9.7 - 12.2 mmHg ) and post colloid treatment was 13.2 mmHg ( 12.0 -14.7 mmHg ) [ Normal range 18 - 22 mmHg ] .
RESULTS	COP was significantly increased with colloid treatment ( p < 0.001 ) but this increase was not significantly different between treatment groups .
RESULTS	Venous pH did not change significantly with treatment .
RESULTS	Twelve horses survived to hospital discharge and survival did not differ significantly between treatment groups .
CONCLUSIONS	Post-treatment COP improved approximately 20 % regardless of the formulation used , however , values did not reach the normal range of COP observed in healthy horses .
CONCLUSIONS	Acid-base parameters were not significantly impacted by either treatment .
CONCLUSIONS	Further study is needed to determine how these two products compare with regards to other outcome measures .
CONCLUSIONS	Evaluation of the relative effects of colloid formulation in horses with clinical disease is a future area of interest .

###25517493
OBJECTIVE	To assess the cardiorespiratory parametes , recovery , gastrointestinal motility and serum cortisol concentrations in horses anesthetized with isoflurane with or without a continuous rate infusion ( CRI ) of butorphanol for orchiectomy .
METHODS	Twelve adult , intact , male horses weighing 332 55 kg were included in the study .
METHODS	Xilazine was administered as premedication .
METHODS	Anesthesia was induced with ketamine and midazolam and maintained with isoflurane .
METHODS	Butorphanol ( 0.025 mg kg-1 bolus ) or an equivalent volume of saline ( 0.9 % ) was given intravenously followed by a CRI of butorphanol ( BG ) ( 13 g kg-1 hour-1 ) or saline ( CG ) .
METHODS	Cardiorespiratory variables were recorded before ( T0 ) and every 15 minutes for 75 minutes after the start of infusion .
METHODS	Serum cortisol concentration was measured at T0 and 60 minutes , and 30 minutes and 19 hours after the horse stood up .
METHODS	Recovery from anesthesia was evaluated using a scoring system .
METHODS	Gastrointestinal motility was evaluated before anesthesia and during 24 hours after recovery .
RESULTS	There were no significant differences between groups in cardiopulmonary variables , or recovery scores or serum cortisol concentrations .
RESULTS	A reduction in gastrointestinal motility was recorded for 60 minutes in BG .
CONCLUSIONS	Continuous rate infusion of butorphanol in horses anesthetized with isoflurane did not adversely affect the cardiopulmonary variables monitored , or recovery scores .
CONCLUSIONS	A small but statistically significant reduction in gastrointestinal motility occurred in the butorphanol group .

###25801652
BACKGROUND	The 4 serotypes of dengue virus , DENV-1-4 , are the leading cause of arboviral disease globally .
BACKGROUND	The ideal dengue vaccine would provide protection against all serotypes after a single dose .
METHODS	Two randomized , placebo-controlled trials were performed with 168 flavivirus-naive adults to demonstrate the safety and immunogenicity of a live attenuated tetravalent dengue vaccine ( TV003 ) , compared with those of a second tetravalent vaccine with an enhanced DENV-2 component ( TV005 ) , and to evaluate the benefit of a booster dose at 6 months .
METHODS	Safety data , viremia , and neutralizing antibody titers were evaluated .
RESULTS	A single dose of TV005 elicited a tetravalent response in 90 % of vaccinees by 3 months after vaccination and a trivalent response in 98 % .
RESULTS	Compared with TV003 , the higher-dose DENV-2 component increased the observed frequency of immunogenicity to DENV-2 in the TV005 trial .
RESULTS	Both the first and second doses were well tolerated .
RESULTS	Neither vaccine viremia , rash , nor a significant antibody boost were observed following a second dose .
CONCLUSIONS	A single subcutaneous dose of TV005 dengue vaccine is safe and induces a tetravalent antibody response at an unprecedented frequency among vaccinees .
CONCLUSIONS	A second dose has limited benefit and appears to be unnecessary .
CONCLUSIONS	Studies to confirm these findings and assess vaccine efficacy will now move to populations in regions where DENV transmission is endemic .
BACKGROUND	NCT01072786 and NCT01436422 .

###25832687
OBJECTIVE	To compare survival , tumor control , toxicities , and quality of life of patients with locally advanced nasopharyngeal carcinoma ( NPC ) treated with induction chemotherapy and concurrent chemo-radiation ( CCRT ) , against CCRT alone .
METHODS	Patients were stratified by N stage and randomized to induction GCP ( 3 cycles of gemcitabine 1000mg/m ( 2 ) , carboplatin area under the concentration-time-curve 2.5 , and paclitaxel 70mg/m ( 2 ) given days 1 and 8 every 21days ) followed by CCRT ( radiation therapy 69.96 Gy with weekly cisplatin 40mg/m ( 2 ) ) , or CCRT alone .
METHODS	The accrual of 172 was planned to detect a 15 % difference in 5-year overall survival ( OS ) with a 5 % significance level and 80 % power .
RESULTS	Between September 2004 and August 2012 , 180 patients were accrued , and 172 ( GCP 86 , control 86 ) were analyzed by intention to treat .
RESULTS	There was no significant difference in OS ( 3-year OS 94.3 % [ GCP ] vs 92.3 % [ control ] ; hazard ratio 1.05 ; 1-sided P = .494 ] ) , disease-free survival ( hazard ratio 0.77 , 95 % confidence interval 0.44-1 .35 , P = .362 ) , and distant metastases-free survival ( hazard ratio 0.80 , 95 % confidence interval 0.38-1 .67 , P = .547 ) between the 2 arms .
RESULTS	Treatment compliance in the induction phase was good , but the relative dose intensity for concurrent cisplatin was significantly lower in the GCP arm .
RESULTS	Overall , the GCP arm had higher rates of grades 3 and 4 leukopenia ( 52 % vs 37 % ) and neutropenia ( 24 % vs 12 % ) , but grade 3 and 4 acute radiation toxicities were not statistically different between the 2 arms .
RESULTS	The global quality of life scores were comparable in both arms .
CONCLUSIONS	Induction chemotherapy with GCP before concurrent chemo-irradiation did not improve survival in locally advanced NPC .

###25108075
OBJECTIVE	Pregnancy-associated plasma protein A ( PAPP-A ) has prognostic impact in pregnancy and acute coronary syndrome .
OBJECTIVE	Patients with chronic kidney disease have an excessive cardiovascular risk .
OBJECTIVE	In an effort to identify novel risk factors for cardiovascular disease , we investigated the relationship of PAPP-A with specific outcomes in diabetic patients undergoing dialysis .
METHODS	PAPP-A was measured in 1098 diabetic hemodialysis patients , who participated in the German Diabetes and Dialysis Study and followed-up for a median of 4 years .
METHODS	By Cox regression analysis , we assessed the association of baseline levels of PAPP-A with all-cause mortality , combined cardiovascular events and the specific outcomes of sudden death , stroke , myocardial infarction and infectious mortality .
RESULTS	Patients had a mean age of 668 years ( 54 % male ) and median PAPP-A concentration of 17mIU/L ( IQR 13.4-20 .9 mIU/L ) .
RESULTS	Per standard deviation increase in PAPP-A the adjusted risk of sudden cardiac death increased by 23 % ( HR 1.23 , 95 % CI 1.12-1 .36 ) .
RESULTS	Categorical analyses showed that the patients in the 4 ( th ) PAPP-A quartile had an adjusted 2.6 fold increased risk of sudden death and 2.8 fold increased risk of stroke as compared to the patients in the 1st quartile .
RESULTS	Similarly , the risk of combined cardiovascular events was significantly elevated by the factor 1.5 in patients of the 4 ( th ) quartile .
RESULTS	Additionally , PAPP-A levels were associated with infectious deaths and all-cause mortality .
CONCLUSIONS	PAPP-A is associated with sudden death , stroke and infectious complications in diabetic dialysis patients .
CONCLUSIONS	PAPP-A may be useful for risk assessment and monitoring in populations at high risk of cardiovascular events .

###24293754
BACKGROUND	Home respiratory polygraphy ( HRP ) may be a cost-effective alternative to polysomnography ( PSG ) for diagnosis and treatment election in patients with high clinical probability of obstructive sleep apnea ( OSA ) , but there is conflicting evidence on its use for a wider spectrum of patients .
OBJECTIVE	To determine the efficacy and cost of OSA management ( diagnosis and therapeutic decision making ) using ( 1 ) PSG for all patients ( PSG arm ) ; ( 2 ) HRP for all patients ( HRP arm ) ; and ( 3 ) HRP for a subsample of patients with high clinical probability of being treated with continuous positive airway pressure ( CPAP ) and PSG for the remainder ( elective HRP arm ) .
METHODS	Multicentric study of 366 patients with intermediate-high clinical probability of OSA , randomly subjected to HRP and PSG .
METHODS	We explored the diagnostic and therapeutic decision agreements between the PSG and both HRP arms for several HRP cutoff points and calculated costs for equal diagnostic and/or therapeutic decision efficacy .
RESULTS	For equal diagnostic and therapeutic decision efficacy , PSG arm costs were 18 % higher than HRP arm costs and 20 % higher than elective HRP arm costs .
RESULTS	HRP arm costs tended to be lower than elective HRP arm costs , and both tended to be lower than PSG arm costs if patient costs were omitted .
CONCLUSIONS	Home respiratory polygraphy is a less costly alternative than polysomnography for the diagnosis and therapeutic decision making for patients with suspected obstructive sleep apnea .
CONCLUSIONS	We found no advantage in cost terms , however , in using home respiratory polygraphy for all patients or home respiratory polygraphy for the most symptomatic patients and polysomnography for the rest .

###24934962
OBJECTIVE	The authors assessed the efficacy and safety of combination treatment with varenicline and sustained-release bupropion for smokers who , based on an assessment of initial smoking reduction prior to the quit date , were deemed unlikely to achieve abstinence using nicotine patch treatment .
METHODS	In a randomized , double-blind , parallel-group adaptive treatment trial , the authors identified 222 cigarette smokers who failed to show a reduction of more than 50 % in smoking after 1 week of nicotine patch treatment .
METHODS	Smokers were randomly assigned to receive 12 weeks of varenicline plus bupropion or varenicline plus placebo .
METHODS	The primary outcome measure was continuous smoking abstinence at weeks 8-11 after the target quit date .
RESULTS	Both treatments were well tolerated .
RESULTS	Participants who received the combination treatment had a significantly higher abstinence rate than those who received varenicline plus placebo ( 39.8 % compared with 25.9 % ; odds ratio = 1.89 ; 95 % CI = 1.07 , 3.35 ) .
RESULTS	Combination treatment had a significantly greater effect on abstinence rate in male smokers ( odds ratio = 4.26 ; 95 % CI = 1.73 , 10.49 ) than in female smokers ( odds ratio = 0.94 ; 95 % CI = 0.43 , 2.05 ) .
RESULTS	It also had a significantly greater effect in highly nicotine-dependent smokers ( odds ratio = 3.51 , 95 % CI = 1.64 , 7.51 ) than in smokers with lower levels of dependence ( odds ratio = 0.71 , 95 % CI = 0.28 , 1.80 ) .
CONCLUSIONS	Among smokers who did not show a sufficient initial response to prequit nicotine patch treatment , combination treatment with varenicline and bupropion proved more efficacious than varenicline alone for male smokers and for smokers with a high degree of nicotine dependence .

###24583757
BACKGROUND	Nonalcoholic steatohepatitis ( NASH ) is common and severe in patients with diabetes mellitus .
BACKGROUND	Although , there are no effective treatments for NASH in diabetic patients , preliminary reports suggest that polyunsaturated fatty acids ( PUFA ) may be beneficial in these patients .
OBJECTIVE	A prospective , randomized , double-blind placebo-controlled study ( NCT 00323414 ) was performed in NASH patients with diabetes .
OBJECTIVE	Clinicaltrials.gov ( NCT 00323414 ) .
METHODS	A total of 37 patients ( 50.6 9.8 y ) with well-controlled diabetes ( HbA1C < 8.5 % ) were randomized to receive either PUFA containing eicosapentaenoic acid ( 2160 mg ) and docosahexaenoic acid ( 1440 mg ) daily or an isocaloric , identical placebo containing corn oil for 48 weeks under CONSORT guidelines .
METHODS	Clinical , demographics , biochemical laboratory tests , body composition using DEXA , and liver biopsy were performed at randomization and at the end of treatment .
METHODS	Liver biopsy was scored by the NASH CRN criteria .
METHODS	An intention-to-treat analysis was performed .
RESULTS	At inclusion , sex , age , body weight , biochemical tests , glucose control , and liver histology were similar in the 2 treatment groups .
RESULTS	There was no change in liver enzymes , body weight , or body composition during the study in either group .
RESULTS	At the end of the treatment , hepatic steatosis and the activity score improved ( P < 0.05 ) and lobular inflammation worsened ( P < 0.001 ) with placebo but was unchanged with PUFA .
RESULTS	At the end of the treatment , insulin resistance ( serum glucose and HOMA ) worsened with PUFA but not placebo .
CONCLUSIONS	PUFA provided no benefit over placebo in NASH patients with diabetes .
CONCLUSIONS	The effects of PUFA on histology and insulin resistance were inferior to placebo .
CONCLUSIONS	These data provide no support for PUFA supplements in NASH .

###25539791
BACKGROUND	Pomaglumetad methionil ( LY2140023 monohydrate ) is a potent and highly selective agonist for the metabotropic glutamate mGluR2 and mGluR3 receptors .
BACKGROUND	We present results of a pivotal clinical study H8Y-MC-HBBM assessing the efficacy of LY2140023 in improving symptoms as a monotherapy in patients with an acute exacerbation of schizophrenia .
METHODS	Enrolled adult patients ( ages 18-65 ) with schizophrenia who had experienced an exacerbation of symptoms within 2weeks prior to study entry .
METHODS	Patients ( N = 1013 ) were randomized 2:2:2:1 to treatment with placebo , LY40 mg twice daily ( BID ) , LY80 mg BID , or risperidone ( RIS ) 2mg BID for 6weeks after a one-week blinded placebo lead-in .
METHODS	The primary outcome assessed change from baseline in the Positive and Negative Syndrome Scale ( PANSS ) total score in an overall schizophrenia population and a predefined subpopulation which excluded non-Hispanic white patients with the A/A genotype at the HTR2A SNP rs7330461 .
RESULTS	Neither LY2140023 dose showed significant improvement compared to placebo on PANSS total in either population ( 1-sided p-value [ significance level ] , overall : LY40 , p = .154 [ 0.01 ] ; LY80 , p = .698 [ 0.01 ] , subpopulation : LY40 , p = .033 [ 0.0025 ] ; LY80 , p = .659 [ 0.0025 ] , MMRM analysis ) .
RESULTS	RIS statistically separated from placebo in both populations ( p < .001 [ 0.05 ] ) .
RESULTS	There were no statistically significant differences in the incidence of serious adverse events , and no seizures on LY2140023 .
CONCLUSIONS	LY2140023 treatment did not demonstrate efficacy in populations studied .
CONCLUSIONS	Overall , LY2140023 treatment was generally well tolerated with no new adverse safety findings compared to previous trials .
CONCLUSIONS	Further understanding of the role of glutamate as a therapeutic target in schizophrenia is needed .
BACKGROUND	A Phase 2 , Multicenter , Double-Blind , Placebo-Controlled Comparator Study of 2 Doses of LY2140023 Versus Placebo in Patients With DSM-IV-TR SchizophreniaClinicalTrials.gov identifier : NCT01086748 .

###25635958
OBJECTIVE	To test the hypothesis that experimental pain in the masseter muscle or temporomandibular joint ( TMJ ) will decrease the anterior maximum voluntary bite force ( MVBF ) and jaw muscle activity in relation to the perceived effort .
METHODS	Sixteen volunteers participated in two experimental sessions .
METHODS	Participants were injected with 0.2 mL of monosodium glutamate ( 1.0 M ) into either the masseter muscle or TMJ .
METHODS	The MVBF and corresponding electromyographic ( EMG ) activity of the masseter , anterior temporalis , and digastric muscles were recorded 10 times at an interval of 2 minutes before and after injection .
METHODS	Pain was measured using a visual analog scale and McGill Pain Questionnaire .
METHODS	In addition , participants were asked how they perceived the interference of pain on their biting performance .
METHODS	The data analysis included a two-way analysis of variance model and t test .
RESULTS	There was no significant difference in peak pain intensity ( P = .066 ) and duration of pain ( P = .608 ) between painful muscle and TMJ injections , but TMJ injection produced a significantly larger area under the curve ( P = .005 ) and a significantly higher pain rating index ( P = .030 ) .
RESULTS	Pain in the muscle ( P = .421 ) and TMJ ( P = .057 ) did not significantly change the MVBF from baseline levels .
RESULTS	The EMG activity also did not differ significantly from baseline levels during muscle pain .
RESULTS	However , there was a significant increase ( P = .028 ) in the EMG activity of the anterior temporalis and a significant decrease ( P = .010 ) in the EMG activity of the anterior digastric muscle compared to baseline during TMJ pain .
RESULTS	Subject-based reports also revealed that in the majority of cases ( 62.5 % ) , pain did not interfere with the MVBF task .
CONCLUSIONS	Experimental pain from either masseter muscle or TMJ did not affect the MVBF , in accordance with the subject-based reports .
CONCLUSIONS	Jaw muscle activity , except for EMG activity of the anterior temporalis and anterior digastric muscles during TMJ pain , also remained unaffected by pain .
CONCLUSIONS	The findings suggest that it is not pain in itself but rather how pain is perceived that may lead to adaptation of motor function , supporting an integrated pain adaptation model .

###24943472
BACKGROUND	Physical inactivity contributes to poor fitness and mental health disorders .
BACKGROUND	This is of concern in post-conflict low-income settings where non-communicable diseases are emerging and there is limited evidence for physical activity interventions .
BACKGROUND	We examined the effects of a sport-for-development programme on adolescent physical fitness and mental health in Gulu , Uganda .
METHODS	We conducted a single-blinded RCT nested within an observational study with three unbalanced parallel groups .
METHODS	Participants were able-bodied adolescents aged 11-14 years .
METHODS	The intervention comprised an 11-week voluntary competitive sport-for-development football league .
METHODS	Participants who did not subscribe for the intervention formed a non-registered comparison group .
METHODS	Boys who registered for the sport-for-development programme were randomly allocated to the intervention or wait-listed .
METHODS	The girls programme subscription was insufficient to form a wait-list and all registrants received the intervention .
METHODS	Physical fitness was assessed by cardiorespiratory fitness ( multi-stage fitness test ) , muscular power ( standing broad jump ) and body composition ( BMI-for-age ) .
METHODS	Mental health was measured using the Acholi Psychosocial Assessment Instrument for local depression-like ( DLS ) and anxiety-like ( ALS ) syndromes .
METHODS	All randomisation was computer generated and assessors were masked to group allocation .
METHODS	An intention-to-treat analysis of adjusted effect size ( ES ) was applied .
RESULTS	There were 1,462 adolescents in the study ( intervention : boys = 74 , girls = 81 ; wait-list : boys = 72 ; comparison : boys = 472 , girls = 763 ) .
RESULTS	At four months follow-up there was no significant effect on the boys fitness when comparing intervention vs wait-listed and intervention vs non-registered groups .
RESULTS	However , there was a negative effect on DLS when comparing boys intervention vs wait-listed ( ES = 0.67 [ 0.33 to 1.00 ] ) and intervention vs non-registered ( ES = 0.25 [ 0.00 to 0.49 ] ) .
RESULTS	Similar results were observed for ALS for boys intervention vs wait-listed ( ES = 0.63 [ 0.30 to 0.96 ] ) and intervention vs non-registered ( ES = 0.26 [ 0.01 to 0.50 ] ) .
RESULTS	There was no significant effect on the girls for any outcomes .
CONCLUSIONS	The sport-for-development league in this study had no impact on fitness and a negative effect on the mental health of participating boys .
CONCLUSIONS	From this research , there is no evidence that voluntary competitive sport-for-development interventions improve physical fitness or mental health outcomes in post-conflict settings .

###25970759
OBJECTIVE	To evaluate the effect of topical haemoglobin spray on treatment response and wound-closure rates in patients with chronic venous leg ulcers .
METHODS	A linear regression model was used to forecast healing outcomes over a 12-month period .
METHODS	Simulated data were taken from normal distributions based on post-hoc analysis of a 72-patient study in non-healing and worsening wounds ( 36 patients receiving standard care and 36 receiving standard care plus topical haemoglobin spray ) .
METHODS	Using a simulated 25,000 ` patients ' from each group , the proportion of wound closure over time was projected .
RESULTS	Simulation results predicted a 55 % wound closure rate at six months in the haemoglobin group , compared with 4 % in the standard care group .
RESULTS	Over a 12-month simulation period , a 43 % overall reduction in wound burden was predicted .
RESULTS	With the haemoglobin spray , 85 % of wounds were expected to heal in 12 months , compared with 13 % in the standard care group .
CONCLUSIONS	Topical haemoglobin spray promises a more effective treatment for chronic venous leg ulcers than standard care alone in wounds that are non-healing or worsening .
CONCLUSIONS	Further research is required to validate these predictions and to identify achievable outcomes in other chronic wound types .

###25186799
BACKGROUND	Immune globulin intravenous ( IGIV ) , 10 % is a donor-derived polyclonal human immunoglobulin G antibody mixture that has potent immune modulatory properties and contains conformation selective anti-amyloid antibodies .
BACKGROUND	We evaluated the safety and tolerability of multiple doses of IGIV , 10 % in Japanese patients with mild to moderate Alzheimer 's disease .
METHODS	Among the 16 subjects , 12 subjects were assigned to the IGIV group and 4 subjects to the placebo group .
METHODS	Subjects received a total of six infusions of either IGIV at a dose of 0.2 or 0.4 g/kg , or placebo every 2 weeks .
RESULTS	A total of 33 treatment-emergent adverse events ( TEAE ) occurred in 14 subjects : 13 TEAE in five subjects in both the IGIV 0.2 and 0.4 g/kg groups , and 7 TEAE in four subjects in the placebo group .
RESULTS	The most common TEAE in the IGIV subjects were nasopharyngitis , injection-site swelling , and erythema .
RESULTS	All 26 TEAE in the IGIV group were considered to be mild .
RESULTS	Only one mild TEAE ( rash ) was considered to be possibly related to the study drug .
RESULTS	There were no significant differences in incidence of TEAE between the treatment groups .
RESULTS	Four serious TEAE were reported , and all of these were considered to be unrelated to the study treatment .
RESULTS	Other assessments related to safety revealed neither clinically significant abnormal values nor findings in the study .
CONCLUSIONS	IGIV is generally safe and well tolerated with multiple intravenous infusions at doses of 0.2 g/kg and 0.4 g/kg in Japanese patients with mild to moderate Alzheimer 's disease .

###25599708
OBJECTIVE	Ghrelin has glucoregulatory and orexigenic actions , but its role in acute hypoglycemia remains uncertain .
OBJECTIVE	We aimed to investigate circulating levels of acylghrelin ( AG ) and unacylated ghrelin ( UAG ) in response to hyperinsulinemia and to hypoglycemia .
METHODS	A randomized , single-blind , placebo-controlled crossover study including 3 study days was performed at a university hospital clinical research center .
METHODS	Nine healthy men completed 3 study days : i ) saline control ( CTR ) , ii ) hyperinsulinemic euglycemia ( HE ) ( bolus insulin 0.1 IE/kg i.v. and glucose 20 % i.v. for 105min , plasma glucose 5mmol/l ) , and iii ) hyperinsulinemic hypoglycemia ( HH ) ( bolus insulin 0.1 IE/kg i.v. ) .
RESULTS	HH and HE suppressed AG concentrations at t = 45-60min as compared with CTR ( P < 0.05 ) .
RESULTS	At t = 90min , a rebound increase in AG was observed in response to HH as compared with both HE and CTR ( P < 0.05 ) .
RESULTS	UAG also decreased during HH and HE at t = 45min ( P < 0.05 ) , whereas the AG-to-UAG ratio remained unaffected .
CONCLUSIONS	This study demonstrates that AG and UAG are directly suppressed by hyperinsulinemia and that AG concentrations increase after a latency of 1h in response to hypoglycemia , suggesting a potential counterregulatory role of AG .

###24709470
BACKGROUND	Fluconazole prophylaxis has demonstrated efficacy in single and multicenter randomized controlled trials without side effects or emergence of resistance .
BACKGROUND	Additional evidence based on incidence of invasive Candida infections , multicenter data , resistance , and safety is desired .
METHODS	We conducted a case-control analysis of efficacy and safety of fluconazole prophylaxis from a multicenter database from a neonatal infection study that included 2017 infants < 1250 grams from 95 NICUs .
METHODS	Infants receiving intravenous antifungal prophylaxis were pre-identified during enrollment in the parent study .
METHODS	For each infant receiving antifungal prophylaxis ( case ) , three infants not receiving antifungal ( controls ) were matched by birth weight ( 50 g ) , by gestational age ( 1 week ) , gender , and study site .
RESULTS	Fluconazole prophylaxis was administered to 127 patients [ 754 163 g birth weight ( BW ) and 25.4 1.7 weeks gestational age ( GA ) ] and were compared with 399 control patients ( 756 163 g BW and 25.5 1.8 weeks GA ) .
RESULTS	Invasive Candida infection occurred in 0.8 % ( 1 of 127 ) infants who received fluconazole prophylaxis compared with 7.3 % ( 29 of 399 ) of matched controls ( p = 0.006 ) .
RESULTS	Candida bloodstream infection occurred in 0.8 % ( 1 of 127 ) fluconazole prophylaxis infants compared with 5.5 % ( 22 of 399 ) of matched controls ( p = 0.02 ) .
RESULTS	There were no differences in late-onset sepsis due to gram-positive or gram-negative organisms , focal bowel perforation , necrotizing enterocolitis , cholestasis , or overall mortality .
CONCLUSIONS	Fluconazole prophylaxis is safe and efficacious in preventing invasive Candida infections .
CONCLUSIONS	Even in NICUs with a low incidence of invasive Candida infections , antifungal prophylaxis for high-risk infants is a proven and safe opportunity for infection prevention in these patients .

###25499395
BACKGROUND	There is substantial debate regarding the development of acute coronary syndrome in patients using proton pump inhibitors ( PPIs ) combined with clopidogrel .
BACKGROUND	However , data remain limited to address the effect of PPIs alone on the subsequent risk of myocardial infarction ( MI ) .
BACKGROUND	We aimed to explore the subsequent risk of MI in PPI users who had no previous history of MI .
METHODS	The records of inpatients and outpatients with PPI prescriptions were retrieved from the Taiwan National Health Insurance Research Database between 2000 and 2009 .
METHODS	We conducted two different study designs , the first using propensity score ( PS ) - matching analyses and the second using case-crossover analyses .
METHODS	The risk of developing MI for PPI users was analyzed in the PS-matched study .
METHODS	The association between risk of MI and prior PPI exposure was further validated in the case-crossover study .
RESULTS	In the PS-matched study , we included 126,367 PPI users and 126,367 PS-matched PPI non-users .
RESULTS	After 120 days of follow-up , PPI use was associated with a 1.58-fold greater risk of MI ( adjusted hazard ratio [ HR ] = 1.58 , 95 % confidence interval [ CI ] = 1.11 to 2.25 ) .
RESULTS	In the case-crossover study , adjusted odds ratios of PPI for MI risk were 4.61 ( 95 % CI = 1.76 to 12.07 ) for the 7-day window and 3.47 ( 95 % CI = 1.76 to 6.83 ) for the 14-day window .
CONCLUSIONS	Use of PPIs may be independently associated with an increased risk of MI .
CONCLUSIONS	However , the benefits of PPIs may greatly outweigh the risks of adverse cardiovascular effects , with number needed to harm of 4357 .

###24810956
BACKGROUND	Noninvasive electrical brain stimulation ( NEBS ) with transcranial direct current ( tDCS ) or random noise stimulation ( tRNS ) applied to the primary motor cortex ( M1 ) can augment motor learning .
OBJECTIVE	We tested whether different types of stimulation alter particular aspects of learning a tracing task over three consecutive days , namely skill acquisition ( online/within session effects ) or consolidation ( offline/between session effects ) .
METHODS	Motor training on a tracing task over three consecutive days was combined with different types and montages of stimulation ( tDCS , tRNS ) .
RESULTS	Unilateral M1 stimulation using tRNS as well as unilateral and bilateral M1 tDCS all enhanced motor skill learning compared to sham stimulation .
RESULTS	In all groups , this appeared to be driven by online effects without an additional offline effect .
RESULTS	Unilateral tDCS resulted in large skill gains immediately following the onset of stimulation , while tRNS exerted more gradual effects .
RESULTS	Control stimulation of the right temporal lobe did not enhance skill learning relative to sham .
CONCLUSIONS	The mechanisms of action of tDCS and tRNS are likely different .
CONCLUSIONS	Hence , the time course of skill improvement within sessions could point to specific and temporally distinct interactions with the physiological process of motor skill learning .
CONCLUSIONS	Exploring the parameters of NEBS on different tasks and in patients with brain injury will allow us to maximize the benefits of NEBS for neurorehabilitation .

###24637998
OBJECTIVE	Combined-modality treatment is standard treatment for patients with clinical stage I/II Hodgkin lymphoma ( HL ) .
OBJECTIVE	We hypothesized that an early positron emission tomography ( PET ) scan could be used to adapt treatment .
OBJECTIVE	Therefore , we started the randomized EORTC/LYSA/FIL Intergroup H10 trial evaluating whether involved-node radiotherapy ( IN-RT ) could be omitted without compromising progression-free survival in patients attaining a negative early PET scan after two cycles of ABVD ( doxorubicin , bleomycin , vinblastine , and dacarbazine ) as compared with standard combined-modality treatment .
METHODS	Patients age 15 to 70 years with untreated clinical stage I/II HL were eligible .
METHODS	Here we report the clinical outcome of the preplanned interim futility analysis scheduled to occur after documentation of 34 events in the early PET-negative group .
METHODS	Because testing for futility in this noninferiority trial corresponds to testing the hypothesis of no difference , a one-sided superiority test was conducted .
RESULTS	The analysis included 1,137 patients .
RESULTS	In the favorable subgroup , 85.8 % had a negative early PET scan ( standard arm , one event v experimental arm , nine events ) .
RESULTS	In the unfavorable subgroup , 74.8 % had a negative early PET scan ( standard arm , seven events v experimental arm , 16 events ) .
RESULTS	The independent data monitoring committee concluded it was unlikely that we would show noninferiority in the final results for the experimental arm and advised stopping random assignment for early PET-negative patients .
CONCLUSIONS	On the basis of this analysis , combined-modality treatment resulted in fewer early progressions in clinical stage I/II HL , although early outcome was excellent in both arms .
CONCLUSIONS	The final analysis will reveal whether this finding is maintained over time .

###25624429
OBJECTIVE	Orteronel ( TAK-700 ) is an investigational , nonsteroidal , reversible , selective 17,20-lyase inhibitor .
OBJECTIVE	This study examined orteronel in patients with metastatic castration-resistant prostate cancer that progressed after docetaxel therapy .
METHODS	In our study , 1,099 men were randomly assigned in a 2:1 schedule to receive orteronel 400 mg plus prednisone 5 mg twice daily or placebo plus prednisone 5 mg twice daily , stratified by region ( Europe , North America [ NA ] , and non-Europe/NA ) and Brief Pain Inventory-Short Form worst pain score .
METHODS	Primary end point was overall survival ( OS ) .
METHODS	Key secondary end points ( radiographic progression-free survival [ rPFS ] , 50 % decrease of prostate-specific antigen [ PSA50 ] , and pain response at 12 weeks ) were to undergo statistical testing only if the primary end point analysis was significant .
RESULTS	The study was unblinded after crossing a prespecified OS futility boundary .
RESULTS	The median OS was 17.0 months versus 15.2 months with orteronel-prednisone versus placebo-prednisone ( hazard ratio [ HR ] , 0.886 ; 95 % CI , 0.739 to 1.062 ; P = .190 ) .
RESULTS	Improved rPFS was observed with orteronel-prednisone ( median , 8.3 v 5.7 months ; HR , 0.760 ; 95 % CI , 0.653 to 0.885 ; P < .001 ) .
RESULTS	Orteronel-prednisone showed advantages over placebo-prednisone in PSA50 rate ( 25 % v 10 % , P < .001 ) and time to PSA progression ( median , 5.5 v 2.9 months , P < .001 ) but not pain response rate ( 12 % v 9 % ; P = .128 ) .
RESULTS	Adverse events ( all grades ) were generally more frequent with orteronel-prednisone , including nausea ( 42 % v 26 % ) , vomiting ( 36 % v 17 % ) , fatigue ( 29 % v 23 % ) , and increased amylase ( 14 % v 2 % ) .
CONCLUSIONS	Our study did not meet the primary end point of OS .
CONCLUSIONS	Longer rPFS and a higher PSA50 rate with orteronel-prednisone indicate antitumor activity .

###24953916
OBJECTIVE	To compare the effectiveness of bupivacaine moistened dressing and conventional dressing in patients requiring split thickness skin graft for reconstruction of various defects .
METHODS	Randomized controlled trial .
METHODS	Department of Plastic Surgery and Burns Unit , Mayo Hospital , King Edward Medical University , Lahore , from January 2011 to January 2013 .
METHODS	One hundred and fifty patients requiring split thickness skin grafting for various soft tissue defects were divided into two groups A and B , with 75 patients in each group .
METHODS	In Group A , skin graft donor site dressing was kept moist with 12 mL/100 cm2 of 0.25 % bupivacaine solution and in Group B , dressing was moistened with same amount of normal saline .
METHODS	Outcome was measured by calculating rescue analgesia requirements in the two groups after 24 hours .
METHODS	Significance was determined by comparing analgesia sparing effect of each dressing using chi-square test .
RESULTS	In Group A , 5 out of 75 ( 6.7 % ) patients required rescue analgesia .
RESULTS	In Group B , 72 out of 75 ( 96 % ) patients required rescue analgesia ( p < 0.0001 ) .
RESULTS	There was 93.3 % effectiveness of bupivacaine soaked dressing while only 4 % effectiveness of conventional dressing .
CONCLUSIONS	Bupivacaine soaked dressing is much more effective in pain relief and in reducing the requirement of rescue analgesia , in early postoperative period , at split thickness skin graft donor site compared to the conventional dressing .

###24889138
BACKGROUND	Unstable steel wire cerclage following open heart surgery may result in increased pain , sternal cut-through , non-union , or dehiscence .
BACKGROUND	These complications lead to longer hospital stays , increased cost , higher morbidity , and patient dissatisfaction .
BACKGROUND	The Figure 8 FlatWire Sternal Closure System is a new construct which is a simple , intuitive , and inexpensive alternative for primary sternal repair following open heart surgery .
BACKGROUND	Prior bench-top testing of FlatWire has demonstrated superior strength and stiffness compared to traditional steel wire .
BACKGROUND	We present our initial experience in a prospective , randomized , single blinded pilot study utilizing this FDA approved system .
METHODS	Sixty-three patients undergoing elective complete sternotomies at a single institution were randomly assigned to receive either the Figure 8 FlatWire or standard steel wire cerclage .
METHODS	All surgeries were performed by a single board certified cardiothoracic surgeon .
METHODS	Data collected included : Age , BMI , pump time , off pump to surgical stop time , length of hospital stay after surgery , cost from time of surgery to discharge , and pain on a visual analog pain scale on the day of discharge , day 30 , and day 60 .
RESULTS	The groups were well matched .
RESULTS	Patients receiving the Figure 8 FlatWire ( 33 ) had a reduction in length of stay compared to patients receiving steel wire circlage ( 30 ) , but it was not statistically significant ( 6.8 vs. 7.8 days respectively , p < 0.093 ) .
RESULTS	Additionally those with the FlatWire reported significantly decreased pain at day of discharge ( 3.07 vs. 4.92 points on pain scale , p < 0.0066 ) , with similar pain scores at 30 and 60days .
RESULTS	Off pump to surgery stop time was increased by 15.9 minutes in patients receiving the FlatWire vs. steel wires ( 55.7 vs. 71.6 minutes , p = 0.00025 ) .
RESULTS	Mean cost from surgery until discharge was $ 87,820.98 in the FlatWire group vs. $ 91,930.29 in the steel wire group ( p < 0.3082 ) .
CONCLUSIONS	Early clinical results suggest that Figure 8 FlatWire provides excellent stability , which resulted in significantly diminished postoperative pain at discharge .
CONCLUSIONS	Although not significant there was a trend toward decreased length of stay , and reduced cost .
CONCLUSIONS	Further clinical research is warranted to expand upon these initial trends and validate long term outcomes .

###25827058
BACKGROUND	Insulin resistance is associated with blunted sympathetic nervous system ( SNS ) response to carbohydrate ingestion which may contribute to postprandial hypotension and impaired body weight homeostasis .
OBJECTIVE	This study was conducted to examine the effects of pharmacological insulin sensitization on whole-body norepinephrine kinetics during a standard 75-g oral glucose tolerance test ( OGTT ) in obese , insulin resistant subjects with metabolic syndrome .
METHODS	Un-medicated individuals ( n = 42 , mean age 560.8 yrs , body mass index 340.6 kg/m ( 2 ) ) were randomised to 12-weeks pioglitazone ( PIO , 15 mg for 6 weeks , then 30 mg daily ) or placebo using a double-blind , parallel group design .
METHODS	Whole-body norepinephrine kinetics ( arterial norepinephrine concentration , calculated spillover and clearance rates ) , spontaneous cardiac baroreflex sensitivity , heart rate and blood pressure were measured at times 0 , 30 , 60 , 90 and 120 minutes during OGTT .
METHODS	Insulin sensitivity was assessed by euglycemic hyperinsulinemic clamp ( M ) and Matsuda index .
RESULTS	PIO increased clamp derived glucose utilisation by 35 % ( P < 0.001 ) and there were concurrent reductions in inflammatory status and plasma triglycerides ( P < 0.05 ) .
RESULTS	Fasting norepinephrine kinetic parameters were unaltered .
RESULTS	PIO treatment was associated with lower plasma insulin incursions , greater reduction in diastolic blood pressure and enhanced baroreflex sensitivity during OGTT ( P all < 0.05 ) .
RESULTS	The overall norepinephrine spillover response ( AUC ( 0-120 ) ) increased significantly in the PIO group ( group time interaction , P = 0.04 ) , with greatest increment at 30 minutes post-glucose ( 10138 ng/min at baseline versus 24148 ng/min post treatment , P = 0.04 ) and correlated with percent improvement in M.
CONCLUSIONS	PIO enhances the early postprandial SNS response to carbohydrate ingestion .

###24433565
BACKGROUND	There is an urgent need for innovative and developmentally appropriate lifestyle interventions to promote healthy lifestyle behaviors and to prevent the early onset of type 2 diabetes and cardiovascular disease risk in obese Latino adolescents .
BACKGROUND	Guided imagery offers promise to reduce stress and promote lifestyle behavior change to reduce disease risk in obese adolescents .
BACKGROUND	Our objectives were : 1 ) To pilot test a new 12-wk lifestyle intervention using a randomized trial design in obese Latino adolescents , in order to determine the effects of the mind-body modality of Interactive Guided ImagerySM ( IGI ) , over and above those of a didactic lifestyle education , on insulin resistance , eating and physical activity behaviors , stress and stress biomarkers ; and 2 ) To explore the role of intervention-related changes in stress and stress biomarkers on changes in metabolic outcomes , particularly insulin resistance .
METHODS	Obese ( BMI > 95th percentile ) , Latino adolescents ( n = 35 , age 14-17 ) were randomized to receive either 12 weekly sessions of a lifestyle education plus guided imagery program ( GI ) , or lifestyle education plus a digital storytelling computer program ( DS ) .
METHODS	Between-group differences in behavioral , biological , and psychological outcomes were assessed using unpaired T-tests and ANCOVA in the 29 subjects who completed the intervention .
RESULTS	The GI group demonstrated significant reductions in leisure sedentary behavior ( p < .05 ) and increases in moderate physical activity ( p < .05 ) compared to DS group , and a trend toward reduced caloric intake in GI vs DS ( p = .09 ) .
RESULTS	Salivary cortisol was acutely reduced by stress-reduction guided imagery ( p < .01 ) .
RESULTS	There were no group differences in adiposity , insulin resistance , perceived stress , or stress biomarkers across the 12-week intervention , though decrease in serum cortisol over the course of the intervention was associated with improved insulin sensitivity ( p = .03 ) independent of intervention group and other relevant co-variates .
CONCLUSIONS	The improvements in physical activity and stress biomarkers following this pilot intervention support the role of guided imagery in promoting healthy lifestyle behavior change and reducing metabolic disease risk in obese Latino adolescent populations .
CONCLUSIONS	Future investigations will be needed to determine the full effects of the Imagine HEALTH intervention on insulin resistance , stress , and stress biomarkers .
BACKGROUND	Clinicaltrials.gov Registry # : NCT01895595 .

###25100424
OBJECTIVE	We examined whether a proactive care smoking cessation intervention designed to overcome barriers to treatment would be especially effective at increasing cessation among African Americans receiving care in the Veterans Health Administration .
METHODS	We analyzed data from a randomized controlled trial , the Veterans Victory over Tobacco study , involving a population-based electronic registry of current smokers ( 702 African Americans , 1569 whites ) and assessed 6-month prolonged smoking abstinence at 1 year via a follow-up survey of all current smokers .
METHODS	We also examined candidate risk adjustors for the race effect on smoking abstinence .
RESULTS	The interaction between patient race and intervention condition ( proactive care vs. usual care ) was not significant .
RESULTS	Overall , African Americans had higher quit rates than Whites ( 13 % vs. 9 % ; P < .006 ) regardless of condition .
CONCLUSIONS	African Americans quit at higher rates than Whites .
CONCLUSIONS	These findings may be a result of the large number of veterans receiving smoking cessation services and the lack of racial differences in receipt of these services as well as racial differences in smoking history , self-efficacy , and motivation to quit that favor African Americans .

###25441055
OBJECTIVE	To identify cognitive predictors of geriatric depression treatment outcome .
METHODS	Older participants completed baseline measures of memory and executive function , health , and baseline and post-treatment Hamilton Depression Scales ( HAM-D ) in a 12-week trial comparing psychotherapies ( problem-solving vs. supportive ; N = 46 ) .
METHODS	We examined cognitive predictors to identify treatment responders ( i.e. , HAM-D scores reduced by50 % ) and remitters ( i.e. , post-treatment HAM-D score10 ) .
RESULTS	Empirically derived decision trees identified poorer performance on switching ( i.e. , Trails B ) , with a cut-score of82 predicting psychotherapy responders .
RESULTS	No other cognitive or health variables predicted psychotherapy outcomes in the decision trees .
CONCLUSIONS	Psychotherapies that support or improve the executive skill of switching may augment treatment response for older patients exhibiting executive dysfunction in depression .
CONCLUSIONS	If replicated , Trails B has potential as a brief cognitive tool for clinical decision-making in geriatric depression .

###25884885
BACKGROUND	Childhood obesity has become an alarming worldwide increasing public health problem .
BACKGROUND	The earlier adiposity rebound occurs , the greater the risk of becoming obese during puberty and adolescence .
BACKGROUND	It has been speculated about the potential influence of vigorous physical activity on modifying the age of onset of adiposity rebound .
BACKGROUND	Moreover , studies aimed to evaluate the effectiveness of physical activity interventions programs on reducing adiposity and other cardiovascular risk factors in children younger than 6years are scarce .
BACKGROUND	This paper describes the rationale and methods of a study aimed to test the effectiveness of a two-years multidimensional pre-school intervention on preventing obesity and improving physical fitness during the adiposity rebound period .
METHODS	Twenty-one schools from the provinces of Cuenca and Ciudad Real , Spain , were randomised to an intervention and a control arm .
METHODS	In the first academic year , children in third grade of pre-school and first grade of primary school in the intervention group received the physical activity intervention ( MOVI-KIDS ) .
METHODS	After an academic year schools were crossed over to the alternative arm .
METHODS	According to the socio-ecological model , the intervention included children , their parents and teachers , and the school environment where MOVI-KIDS was conducted .
METHODS	MOVI-KIDS consisted of : i ) three-h/week sessions of recreational non-competitive physical activity in after-school time ; ii ) educational materials to parents and teachers about physical activity benefits and sedentary lifestyle risks ; and iii ) modifications in the playground to promote physical activity during recess .
METHODS	Baseline and post-intervention outcomes are going to be measured in both arms three times , at the beginning and at the end of first academic year , and at the end of the second academic year .
METHODS	Primary outcomes included body mass index , waist circumference , triceps skinfold thickness , percentage of both body fat and fat-free mass , and blood pressure .
METHODS	Secondary end points were physical activity , fitness , and carotid intima-media thickness .
CONCLUSIONS	This paper reports the design of a randomised cross-over cluster trial aimed at assessing the effectiveness of the multidimensional physical activity intervention ( MOVI-KIDS ) during two years in pre-school children .
BACKGROUND	Clinical trials.gov : NCT01971840 .
BACKGROUND	( Date of registration : Initial Release : 10/07/2013 ; Record Verification : 23/10/2013 ) .

###24951991
BACKGROUND	The metabolic syndrome is related to the increase in cardiovascular diseases .
BACKGROUND	Polyunsaturated fatty acids from fish oil help in reducing cardiovascular risk factors and are natural bindings of PPAR2 .
OBJECTIVE	To evaluate the impact of hypocaloric diet associated with microencapsulated fish oil supplementation in women with metabolic syndrome .
METHODS	We conducted a randomized , single-blind and placebo-controlled clinical trial with adult women who presented metabolic syndrome ( n = 30 ) for 90 days .
METHODS	The volunteers were divided into two groups : placebo group ( n = 15 ) and microencapsulated fish oil group ( n = 15 ) ( 3 g/day of microencapsulated fish oil containing 0.41 g/day of eicosapentaenoic acid and decosahexaneoic acid ) .
METHODS	Anthropometric , body composition , clinical and laboratory parameters were assessed before and after the intervention .
METHODS	Paired t-test was used for comparisons within groups and Student 's t-test for comparison between groups .
METHODS	We considered p < 0.05 as significant values .
RESULTS	The comparison between groups revealed a significant reduction of blood glucose , insulinemia and the homeostasis model assessment in the microencapsulated fish oil group after 90 days , as opposed to the placebo group .
RESULTS	We also observed reduction of the systolic arterial pressure in the microencapsulated fish oil group .
CONCLUSIONS	A hypocaloric diet associated with the consumption of microencapsulated fish oil was effective in reducing blood glucose , insulinemia and insulin resistance in women with MS.

###25667250
OBJECTIVE	Motivational interviewing ( MI ) has been shown to be an effective strategy for targeting obesity in adolescents , and parental involvement is associated with increased effectiveness .
OBJECTIVE	The aim of this study was to evaluate and compare the role of parental involvement in MI interventions for obese adolescents .
METHODS	A total of 357 Iranian adolescents ( aged 14-18 years ) were randomized to receive an MI intervention or an MI intervention with parental involvement ( MI + PI ) or assessments only ( passive control ) .
METHODS	Data regarding anthropometric , biochemical , psychosocial , and behavioral measures were collected at baseline and 12 months later .
METHODS	A series of intention-to-treat , 2-way repeated-measures analysis of covariance were performed to examine group differences in change in outcomes measures over the 12-month follow-up period .
RESULTS	Results revealed significant effects on most of the outcome parameters for MI + PI ( eg , mean SD BMI z score : 2.58 0.61 ) compared with the passive control group ( 2.76 0.70 ; post hoc test , P = .02 ) , as well as an additional superiority of MI + PI compared with MI only ( 2.81 0.76 ; post hoc test , P = .05 ) .
RESULTS	This pattern was also shown for most of the anthropometric , biochemical , psychometric , and behavioral outcome variables .
CONCLUSIONS	MI with parental involvement is an effective strategy in changing obesity-related outcomes and has additional effects beyond MI with adolescents only .
CONCLUSIONS	These findings might be important when administering MI interventions in school settings .

###24885789
BACKGROUND	Central venous catheters play an important role in patient care .
BACKGROUND	Real-time ultrasound-guided subclavian central venous ( SCV ) cannulation may reduce the incidence of complications and the time between skin penetration and the aspiration of venous blood into the syringe .
BACKGROUND	Ultrasonic diagnosis of catheter misplacement and pneumothorax related to central venous catheterization is rapid and accurate .
BACKGROUND	It is unclear , however , whether ultrasound real-time guidance and examination can reduce procedure times and complication rates when compared with landmark guidance and radiographic examination for SCV catheterization .
METHODS	The Subclavian Central Venous Catheters Guidance and Examination by UltraSound ( SUBGEUS ) study is an investigator-initiated single center , randomized , controlled two-arm trial .
METHODS	Three hundred patients undergoing SCV catheter placement will be randomized to ultrasound real-time guidance and examination or landmark guidance and radiographic examination .
METHODS	The primary outcome is the time between the beginning of the procedure and control of the catheter .
METHODS	Secondary outcomes include the times required for the six components of the total procedure , the occurrence of complications ( pneumothorax , hemothorax , or misplacement ) , failure of the technique and occurrence of central venous catheter infections .
CONCLUSIONS	The SUBGEUS trial is the first randomized controlled study to investigate whether ultrasound real-time guidance and examination for SCV catheter placement reduces all procedure times and the rate of complications .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01888094 .

###25030264
BACKGROUND	Disturbance in sleep quality is a symptom of Major Depressive Disorder ( MDD ) and Bipolar Disorder ( BD ) and thus improving quality of sleep is an important aspect of successful treatment .
BACKGROUND	Here , a prospective , double-blind , randomized , placebo-controlled study examined the effect of olanzapine ( an atypical antipsychotic ) augmentation therapy on sleep architecture , specifically slow wave sleep ( SWS ) , in the treatment of depression .
BACKGROUND	The effect of olanzapine augmentation therapy on other features of sleep ( e.g. , sleep continuity ) and depression ( e.g. , illness severity and cognitive function ) were also determined .
METHODS	Patients currently experiencing a major depressive episode and who were on a stable medication were included .
METHODS	Sleep architecture was measured by overnight ambulatory polysomnography .
METHODS	Illness severity was determined using the Montgomery-Asberg Depression Rating Scale ( MADRS ) .
METHODS	Cognitive function was examined using Cambridge Neuropsychological Test Automated Battery ( CANTAB ) : Spatial Working Memory ( SWM ) , Spatial Span ( SSP ) , and Reaction Time ( RTI ) tasks .
METHODS	Polysomnographs , clinical measures and cognitive tests were administered at baseline , after 2-4 days of treatment and after 28-31 days of treatment .
METHODS	Twenty-five patients participated in the study ( N = 10 , N = 15 for placebo and olanzapine treated groups respectively ) .
RESULTS	The primary objective of the study was to assess the objective ( polysomnographic ) changes in sleep quality , defined as changes in SWS , following olanzapine treatment for depression .
RESULTS	Latency to but not duration of SWS was found to significantly differ between olanzapine - and placebo-treated participants ( Hedge 's g : 0.97 , 0.13 respectively ) .
RESULTS	A significant improvement in olanzapine-treated participants over placebo-treated participants was observed in secondary outcome measures , including sleep efficiency , total sleep time , and sleep latency .
RESULTS	Secondary objectives assessed the subjective changes in sleep quality parameters and correlated them with measures of illness severity and changes in cognition .
RESULTS	MADRS scores were significantly improved in olanzapine-treated participants over time but not more than placebo treatment .
RESULTS	There was no significant difference between olanzapine - and placebo-treated participants in SWM , SSP or RTI tasks .
CONCLUSIONS	Olanzapine augmentation treatment generally did not improve SWS but did improve sleep continuity and depression .
CONCLUSIONS	Olanzapine may be one of few medications that improve sleep continuity , thus directly targeting symptoms of depression .
BACKGROUND	ClinicalTrials.gov , NCT00520507 .

###24755123
OBJECTIVE	To demonstrate bioequivalence of linagliptin/metformin fixed-dose combination ( FDC ) tablets and the corresponding combination of individual tablets taken together , i.e. , free-pill ( FP ) treatment .
METHODS	Three dosing combinations were evaluated in three separate randomized studies : linagliptin 2.5 mg with 500 mg , 850 mg , or 1,000 mg metformin .
METHODS	These studies used a prospective , open-label , randomized , two-way crossover design to evaluate bioequivalence in healthy volunteers ( n = 287 ) .
METHODS	After an overnight fast , participants received an FDC tablet once , and on a separate visit received the corresponding FP treatment .
METHODS	The two possible treatment sequences ( FDC/FP and FP/FDC ) were randomly allocated to the participants .
METHODS	A washout period of 35 days separated the two study treatments .
METHODS	The primary endpoints were maximum plasma concentration ( Cmax ) of linagliptin and metformin , area under the plasma concentration time curve from 0 to 72 hours ( AUC0-72 ) for linagliptin , and from 0 to infinity ( AUC0-inf ) for metformin .
RESULTS	The 90 % confidence intervals of the adjusted geometric mean ratios of Cmax and AUC ( calculated as FDC / FP ) were within the bioequivalence acceptance limits of 80 - 125 % .
RESULTS	The number of participants reporting at least one adverse event following FDC treatments was comparable to , or less than , that following FP treatments .
RESULTS	Evaluation of vital signs and clinical laboratory tests revealed no safety issues .
CONCLUSIONS	FDC tablets of linagliptin and metformin are bioequivalent to individual tablets of respective dose strengths taken together .
CONCLUSIONS	Both treatments were well tolerated .

###24485327
BACKGROUND	There are few evidence-based mobile health solutions for treating adolescent obesity .
BACKGROUND	The primary aim of this parallel non-inferiority trial is to assess the effectiveness of an experimental smartphone application in reducing obesity at 12 months , compared to the Temple Street W82GO Healthy Lifestyles intervention .
METHODS	The primary outcome measure is change in body mass index standardised deviation score at 12 months .
METHODS	The secondary aim is to compare the effect of treatment on secondary outcomes , including waist circumference , insulin sensitivity , quality of life , physical activity and psychosocial health .
METHODS	Adolescents with a body mass index at or above the 98th percentile ( 12 to 17 years ) will be recruited from the Obesity clinic at Temple Street Children 's University Hospital in Dublin , Ireland .
METHODS	W82GO is a family-based lifestyle change intervention delivered in two phases over 12 months .
METHODS	In the current study , participants will be randomised for phase two of treatment to either usual care or care delivered via smartphone application .
METHODS	One hundred and thirty-four participants will be randomised between the two study arms .
METHODS	An intention-to-treat analysis will be used to compare treatment differences between the groups at 12 months .
CONCLUSIONS	The results of this study will be disseminated via open access publication and will provide important information for clinicians , patients and policy makers regarding the use of mobile health interventions in the management of adolescent obesity .
BACKGROUND	Clinicaltrials.gov NCT01804855 .

###24349486
BACKGROUND	Degradation of the somatosensory system has been implicated in postural instability and increased falls risk for older people and Parkinson 's disease ( PD ) patients .
BACKGROUND	Here we demonstrate that textured insoles provide a passive intervention that is an inexpensive and accessible means to enhance the somatosensory input from the plantar surface of the feet .
METHODS	20 healthy older adults ( controls ) and 20 participants with PD were recruited for the study .
METHODS	We evaluated effects of manipulating somatosensory information from the plantar surface of the feet using textured insoles .
METHODS	Participants performed standing tests , on two different surfaces ( firm and foam ) , under three footwear conditions : 1 ) barefoot ; 2 ) smooth insoles ; and 3 ) textured insoles .
METHODS	Standing balance was evaluated using a force plate yielding data on the range of anterior-posterior and medial-lateral sway , as well as standard deviations for anterior-posterior and medial-lateral sway .
RESULTS	On the firm surface with eyes open both the smooth and textured insoles reduced medial-lateral sway in the PD group to a similar level as the controls .
RESULTS	Only the textured insole decreased medial-lateral sway and medial-lateral sway standard deviation in the PD group on both surfaces , with and without visual input .
RESULTS	Greatest benefits were observed in the PD group while wearing the textured insoles , and when standing on the foam surface with eyes closed .
CONCLUSIONS	Data suggested that textured insoles may provide a low-cost means of improving postural stability in high falls-risk groups , such as people with PD .

###25790846
OBJECTIVE	A randomized controlled trial was conducted to evaluate the efficacy of impedance control of a radiofrequency interstitial thermal ablation system ( RITA ) used to treat hepatocellular carcinoma ( HCC ) .
METHODS	Fifteen patients with hypervascular HCCs < 20 mm in diameter were randomly treated with radiofrequency ablation ( RFA ) using conventional temperature control ( group A ) or impedance control methods ( group B ) .
METHODS	RITA needle electrodes were used in all cases .
METHODS	We compared ablation time , extent of lesion ablation , and energy use between the two groups .
RESULTS	The median long and short diameters of the axial cross sections of radiofrequency-induced necrotic areas visualized by CT were 32 mm ( range , 26-36 ) and 25 mm ( 20-31 ) in group A and 32 mm ( 28-40 ) and 31 mm ( 24-37 ) in group B , respectively .
RESULTS	The short diameter of group B patients was significantly greater than that of group A patients ( p = 0.029 ) .
RESULTS	The median ablation time was 18.8 min in group A and 13.4 min in group B , thus significantly shorter in group B ( p = 0.001 ) .
RESULTS	The energy requirement did not differ significantly between the groups .
CONCLUSIONS	Impedance control of the RITA system resulted in an increased size of the ablation zone and a decreased ablation time .

###24820300
OBJECTIVE	To investigate clinical outcome of laparoendoscopic single-site compared with traditional three-port in treatment of ovarian cystectomy .
METHODS	From February 2012 to June 2013 , 54 patients with ovarian cyst were randomized to the single-site group ( n = 24 ) or the three-port group ( n = 30 ) in Peking Union Medical College Hospital .
METHODS	The outcome of laparoscopic single-site and three-port ovarian cystectomy were evaluated .
METHODS	Operation time , blood loss , surgical complications , postoperative pain score , postoperative analgesic requirements , length of hospital stay , cosmetic satisfaction score , postoperative recovery and total cost were compared between both groups .
RESULTS	No difference was found in blood loss , length of hospital stay , complications and total cost between the two groups ( P > 0.05 ) .
RESULTS	Operation time was ( 31 10 ) minute in three-port group and ( 40 19 ) minute in single-site group .
RESULTS	Visual analogue pain score was 5.6 1.7 in three-port group and 2.7 1.4 in single-site group , cosmetic satisfaction score was 92.5 2.5 in three-port group and 97.4 1.5 in single-site group .
RESULTS	Those clinical parameter reached statistical difference ( all P < 0.05 ) .
CONCLUSIONS	Laparoendoscopic single site surgery approach is feasible and safe to treat benign ovarian cyst disease .
CONCLUSIONS	And it offers decreased pain and offer improved cosmesis .

###25361982
BACKGROUND	Although colon cancer ( CC ) with microsatellite instability ( MSI ) has a more favorable prognosis than microsatellite stable ( MSS ) CC , the impact varies according to clinicopathological parameters .
BACKGROUND	We studied how MSI status affects prognosis in a trial-based cohort of stage II and III CC patients treated with 5-fluorouracil ( 5-FU ) / leucovorin or FOLFIRI .
METHODS	Tissue specimens of 1254 patients were tested for 10 different loci and were classified as MSI-high ( MSI-H ) when three or more loci were unstable and MSS otherwise .
METHODS	Study end points were overall survival ( OS ) and relapse-free survival ( RFS ) .
RESULTS	In stage II , RFS and OS were better for patients with MSI-H than with MSS CC [ hazard ratio ( HR ) 0.26 , 95 % CI 0.10-0 .65 , P = 0.004 and 0.16 , 95 % CI 0.04-0 .64 , P = 0.01 ) .
RESULTS	In stage III , RFS was slightly better for patients with MSI-H CC ( HR 0.67 , 95 % CI 0.46-0 .99 , P = 0.04 ) , but the difference was not statistically significant for OS ( HR 0.70 , 95 % CI 0.44-1 .09 , P = 0.11 ) .
RESULTS	Outcomes for patients with MSI-H CC were not different between the two treatment arms .
RESULTS	RFS was better for patients with MSI-H than with MSS CC in the right and left colon , whereas for OS this was significant only in the right colon .
RESULTS	For patients with KRAS - and BRAF-mutated CC , but not for double wild-type patients , RFS and OS were significantly better when the tumors were also MSI-H .
RESULTS	An interaction test was statistically significant for KRAS and MSI status ( P = 0.005 ) , but not for BRAF status ( P = 0.14 ) .
CONCLUSIONS	Our results confirm that for patients with stage II CC but less so for those with stage III MSI-H is strongly prognostic for RFS and OS .
CONCLUSIONS	In the presence of 5-FU treatment , stage II patients with MSI-H tumors maintain their survival advantage in comparison with MSS patients and adding irinotecan has no added benefit .
CONCLUSIONS	CLINICALTRIALS.GOV IDENTIFIER : NCT00026273 .

###24511914
OBJECTIVE	To evaluate the effectiveness of an eHealth intervention on recovery and return to work , after gynaecological surgery .
METHODS	Randomised multicentre trial that ran from March 2010 until September 2011 .
METHODS	Secondary care in seven general and university hospitals in The Netherlands .
METHODS	A cohort of 215 women ( aged 18-65 years ) who had a hysterectomy and/or laparoscopic adnexal surgery for a benign indication .
METHODS	The women were randomly assigned to the intervention group ( n = 110 ) or the control group ( n = 105 ) .
METHODS	The intervention group received an eHealth programme that provided personalised tailor-made pre - and postoperative instructions on the resumption of daily activities , including work , and tools to improve self-empowerment and to identify recovery problems .
METHODS	The control group was provided with access to a control website .
METHODS	The primary outcome was the duration of sick leave until a full sustainable return to work .
METHODS	Secondary outcome measures were quality of life , general recovery , and pain intensity .
RESULTS	In intention-to-treat analysis the eHealth intervention was effective on time to return to work ( hazard ratio 1.43 ; 95 % confidence interval 1.003-2 .040 ; P = 0.048 ) .
RESULTS	The median duration of sick leave until a full sustainable return to work was 39 days ( interquartile range 20-67 days ) in the intervention group and 48 days ( interquartile range 21-69 days ) in the control group .
RESULTS	After 26 weeks pain intensity was lower ( visual analogue scale , cumulative odds ratio 1.84 ; 95 % confidence interval 1.04-3 .25 ; P = 0.035 ) and quality of life was higher ( Rand-36 health survey , between-group difference 30 , 95 % confidence interval 4-57 ; P = 0.024 ) in the intervention group , compared with the control group .
CONCLUSIONS	The use of the eHealth intervention by women after gynaecological surgery results in a faster return to work , with a higher quality of life and less pain .

###25099185
OBJECTIVE	To evaluate the safety and efficacy of abiraterone acetate and prednisolone in Korean and Taiwanese patients with metastatic castration-resistant prostate cancer not responding to docetaxel-based chemotherapy .
METHODS	In this single-arm study , 82 metastatic castration-resistant prostate cancer patients who failed docetaxel-based chemotherapy were treated with abiraterone ( 1000 mg , once daily ) and prednisolone ( 5 mg , twice daily ) .
METHODS	Patients achieving a prostate-specific antigen decline 50 % were considered as responding .
RESULTS	A total of 35 patients ( 43 % ) achieved prostate-specific antigen response ( 95 % confidence interval 32-54 ) .
RESULTS	The median time to prostate-specific antigen progression was 4.7 months ( 95 % confidence interval 3.7-8 .3 ) ; the median overall survival was 11.8 months .
RESULTS	Two ( 4 % ) of 50 patients with measurable disease achieved partial response .
RESULTS	The median testosterone concentration was in the castration range ( 1.21 nmol/L ) throughout the treatment period .
RESULTS	Median dehydroepiandrosterone sulfate decreased from 0.725 mol/L ( baseline ) to 0.080 mol/L ( cycle 4 ) .
RESULTS	The most common adverse event was bone pain ( 20 % ) ; grade 3/4 adverse event of special interest were hypokalemia ( 7 % ) , fluid retention and liver function abnormalities ( 5 % each ) , hypertension ( 2 % ) , and cardiac disorders ( 1 % ) .
CONCLUSIONS	A combination of abiraterone acetate and prednisolone appears to be a favorable second-line treatment in Taiwanese and Korean patients with advanced metastatic castration-resistant prostate cancer after failed docetaxel-based chemotherapy .

###25319731
OBJECTIVE	Predictors of response to treatment with peginterferon plus ribavirin are well established .
OBJECTIVE	In these post-hoc analyses of the REALIZE study , we sought to identify predictors of response for telaprevir-based triple therapy .
METHODS	Patients from the REALIZE study with baseline data for all predictors evaluated ( including baseline disease characteristics and demographics , prior treatment response and baseline laboratory assessments ) were included in the post-hoc analyses ( n = 465 ) .
METHODS	Univariate and multivariate analyses were used to evaluate factors predicting treatment outcomes .
RESULTS	Sustained viral response ( SVR ) rates were 86 % in prior relapsers , 63 % in prior partial responders and 32 % in prior null-responders .
RESULTS	In the final multivariate analysis , baseline factors predicting SVR were prior response to treatment [ Odds ratio ( OR ) = 2.80 ; 95 % confidence interval ( CI ) , 2.13-3 .69 ] , low-density lipoprotein ( LDL ) ( 2.6 mmol/L ) ( OR = 2.11 ; 95 % CI , 1.52-2 .93 ) , HCV genotype ( OR = 0.58 ; 95 % CI , 0.36-0 .93 ) , and maximum alanine amino transferase and aspartate amino transferase ( OR = 0.62 ; 95 % CI , 0.40-0 .97 ) .
CONCLUSIONS	Prior response to peginterferon plus ribavirin treatment and LDL levels are the main independent predictive markers of response with telaprevir-based triple therapy .

###24930475
OBJECTIVE	To compare primary intra-ocular lens ( IOL ) implantation with use of press-on spherical lens for aphakia correction following unilateral infantile cataract removal .
METHODS	Sixty infants with a unilateral cataract underwent cataract surgery and were randomly assigned to the IOL ( A group ) or no IOL group ( B group ) .
METHODS	Residual refractive error was corrected with spectacles in the A group and a press-on spherical lens was used to treat aphakia in the B group .
METHODS	Grating visual acuity ( VA ) was measured and patients were followed for up to 1 year .
RESULTS	LogMAR VA in the operated eyes of both groups was significantly better 1 year than 1 month after surgery .
RESULTS	Mean logMAR VA difference between 1 year and 1 month after surgery was higher in the A group ( 0.457 0.110 ) than in the B group ( 0.323 0.114 , p < 0.0001 ) .
RESULTS	Serious inflammation occurred significantly more often in the A group than in the B group ( p = 0.007 ) .
RESULTS	Visual axis opacity occurred more often in the A group than in the B group ( pupillary membrane : A : six eyes , 20 % , B : none , p = 0.024 ; lens reproliferation : A : 10 eyes , 33 % , B : two eyes , 7 % , p = 0.021 ) .
RESULTS	Glaucoma occurred equally in both groups ( p = 0.612 ) .
RESULTS	No other complications occurred .
CONCLUSIONS	Primary IOL implantation appears to be a relatively safe , effective optical correction strategy following unilateral cataract extraction in this age group .
CONCLUSIONS	Patients for whom an IOL is not suitable can be treated with a press-on spherical lens for optical correction .

###25433572
BACKGROUND	Labor epidural analgesia is highly effective , but can be limited by slow onset and incomplete blockade .
BACKGROUND	The administration of warmed , compared to room temperature , bupivacaine has resulted in more rapid onset epidural anesthesia .
BACKGROUND	We hypothesized that the administration of bupivacaine with fentanyl at 37C versus 20C would result in improved initial and ongoing labor epidural analgesia .
METHODS	In this prospective , randomized , doubled blinded study , 54 nulliparous , laboring women were randomized to receive epidural bupivacaine 0.125 % with fentanyl 2 g/mL ( 20 mL initial and 6 mL hourly boluses ) at either 37C or 20C .
METHODS	Pain verbal rating scores ( VRS ) , sensory level , oral temperature , and side effects were assessed after epidural loading ( time 0 ) , at 5 , 10 , 15 , 20 , 30 , 60 min , and at hourly intervals .
METHODS	The primary outcome was the time to achieve initial satisfactory analgesia ( VRS 3 ) .
METHODS	Secondary outcomes included ongoing quality of sensory blockade , body temperature and shivering .
RESULTS	There were no differences between groups in patient demographics , initial pain scores , cervical dilatation , body temperature or mode of delivery .
RESULTS	Epidural bupivacaine at 37C resulted in shorter mean ( SD ) analgesic onset time ( 9.24.7 vs. 16.010.5 min , P = 0.005 ) and improved analgesia for the first 15 min after initial bolus ( P = 0.001-0 .03 ) .
RESULTS	Although patient temperature increased during the study ( P < 0.01 ) , there were no differences between the groups ( P = 0.09 ) .
RESULTS	Six ( 24 % ) and 10 ( 40 % ) patients experienced shivering in the 37C and 20C groups , respectively ( P = 0.23 ) .
CONCLUSIONS	The administration of epidural 0.125 % bupivacaine with fentanyl 2g/mL at 37C versus 20C resulted in more rapid onset and improved labor analgesia for the first 15 min .
CONCLUSIONS	There was no evidence of improved ongoing labor analgesia or differences in side effects between groups .

###25681001
OBJECTIVE	To compare the outcomes of sub-Bowman keratomileusis ( 100-m flap ) and laser in situ keratomileusis ( LASIK ) ( 120-m flap ) using 150-kHz femtosecond laser .
METHODS	Randomized , double-masked , contralateral clinical trial .
METHODS	One hundred patients ( 200 eyes ) with myopia or myopic astigmatism were included .
METHODS	Postoperative examinations were performed at week 1 and months 1 , 3 , 6 , and 12 .
METHODS	Main outcome measures included postoperative uncorrected ( UCVA ) and best-corrected distance visual acuity ( BCVA ) ; manifest refraction spherical equivalent ; efficacy and safety indices ; corneal thickness ; and complications .
RESULTS	The mean age of patients was 33.9 7.9 years .
RESULTS	Overall , the preoperative UCVA , BCVA , and manifest refraction spherical equivalent were 1.349 0.332 , -0.022 0.033 , and -5.81 1.61 diopters , respectively .
RESULTS	No significant difference was observed in preoperative ( P .226 ) or intraoperative parameters ( P .452 ) between both groups , except residual stromal thickness ( P < .001 ) .
RESULTS	The UCVA , manifest refraction spherical equivalent , and central corneal thickness stabilized by 1 week , while the thinnest corneal thickness stabilized by 3 months postoperatively .
RESULTS	There was no significant difference between both groups for any parameter during all follow-up visits ( P .132 ) except the 3-month safety index , which was better in the sub-Bowman keratomileusis group ( P = .007 ) .
RESULTS	Soft opaque bubble layer was noted intraoperatively in 12 cases ( 7 , 100-m group ; 5 , 120-m group ; P = .577 ) .
RESULTS	No postoperative complications were observed .
CONCLUSIONS	Our study did not find any differences in the visual and refractive outcomes between femtosecond-assisted sub-Bowman keratomileusis and LASIK .
CONCLUSIONS	Both surgeries resulted in quick visual recovery as early as 1 week postoperatively .

###25022724
OBJECTIVE	Developmental delays and disabilities are common in children .
OBJECTIVE	Research has indicated that intervention during the early years of a child 's life has a positive effect on cognitive development , social skills and behavior , and subsequent school performance .
OBJECTIVE	To determine whether a computerized clinical decision support system is an effective approach to improve standardized developmental surveillance and screening ( DSS ) within primary care practices .
METHODS	In this cluster randomized clinical trial performed in 4 pediatric clinics from June 1 , 2010 , through December 31 , 2012 , children younger than 66 months seen for primary care were studied .
METHODS	We compared surveillance and screening practices after adding a DSS module to an existing computer decision support system .
METHODS	The rates at which children were screened for developmental delay .
RESULTS	Medical records were reviewed for 360 children ( 180 each in the intervention and control groups ) to compare rates of developmental screening at the 9 - , 18 - , or 30-month well-child care visits .
RESULTS	The DSS module led to a significant increase in the percentage of patients screened with a standardized screening tool ( 85.0 % vs 24.4 % , P < .001 ) .
RESULTS	An additional 120 records ( 60 each in the intervention and control groups ) were reviewed to examine surveillance rates at visits outside the screening windows .
RESULTS	The DSS module led to a significant increase in the percentage of patients whose parents were assessed for concerns about their child 's development ( 71.7 % vs 41.7 % , P = .04 ) .
CONCLUSIONS	Using a computerized clinical decision support system to automate the screening of children for developmental delay significantly increased the numbers of children screened at 9 , 18 , and 30 months of age .
CONCLUSIONS	It also significantly improved surveillance at other visits .
CONCLUSIONS	Moreover , it increased the number of children who ultimately were diagnosed as having developmental delay and who were referred for timely services at an earlier age .
BACKGROUND	clinicaltrials.gov Identifier : NCT01351077 .

###24560541
BACKGROUND	The HVTN 503/Phambili study , which assessed the efficacy of the Merck Ad5 gag/pol/nef subtype B HIV-1 preventive vaccine in South Africa , was stopped when futility criteria in the Step study ( assessing the same vaccine in the Americas , Caribbean , and Australia ) were met .
BACKGROUND	Here we report long-term follow-up data .
METHODS	HVTN 503/Phambili was a double-blind , placebo-controlled , randomised trial that recruited HIV-1 uninfected , sexually active adults aged 18-35 years from five sites in South Africa .
METHODS	Eligible participants were randomly assigned ( 1:1 ) by computer-generated random numbers to either vaccine or placebo , stratified by site and sex .
METHODS	Cox proportional hazards models were used to estimate HIV-1 infection in the modified intention-to-treat cohort , all of whom were unmasked early in follow-up .
METHODS	The trial is registered with ClinicalTrials.gov , number NCT00413725 and the South African National Health Research Database , number DOH-27-0207-1539 .
RESULTS	Between Jan 24 , 2007 , and Sept 19 , 2007 , 801 participants ( 267 % ) of a planned 3000 were randomly assigned ( 400 to vaccine , 401 to placebo ) ; 216 ( 27 % ) received only one injection , 529 ( 66 % ) received only two injections , and 56 ( 7 % ) received three injections .
RESULTS	At a median follow-up of 42 months ( IQR 31-42 ) , 63 vaccine recipients ( 16 % ) had HIV-1 infection compared with 37 placebo recipients ( 9 % ; adjusted HR 170 , 95 % CI 113-255 ; p = 001 ) .
RESULTS	Risk for HIV-1 infection did not differ according to the number of vaccinations received , sex , circumcision , or adenovirus type 5 ( Ad5 ) serostatus .
RESULTS	Differences in risk behaviour at baseline or during the study , or annualised dropout rate ( 77 % [ 95 % CI 62-95 ] for vaccine recipients vs 88 % [ 71-107 ] for placebo recipients ; p = 040 ) are unlikely explanations for the increased rate of HIV-1 infections seen in vaccine recipients .
CONCLUSIONS	The increased risk of HIV-1 acquisition in vaccine recipients , irrespective of number of doses received , warrants further investigation to understand the biological mechanism .
CONCLUSIONS	We caution against further use of the Ad5 vector for HIV vaccines .
BACKGROUND	National Institute of Allergy and Infectious Diseases , Merck , and South African Medical Research Council .

###24766756
OBJECTIVE	Patients entering treatment for alcohol problems do not have uniform treatment goals , and a pretreatment drinking goal has a significant impact on treatment outcome .
OBJECTIVE	The objective of this study was to understand better how an array of individual characteristics , including factors that affect treatment , are related to treatment goals before beginning alcohol treatment in the COMBINE ( Combining Medications and Behavioral Interventions ) Study .
METHODS	Participants were alcohol-dependent individuals ( N = 1,156 ; 357 women ) recruited at 11 outpatient academic alcoholism-treatment clinics across the United States to participate in a randomized , double-blind , placebo-controlled trial that combined behavioral intervention with acamprosate and/or naltrexone .
METHODS	Treatment goal was coded as controlled drinking , conditional abstinence , or total abstinence .
METHODS	Multinomial logistic regressions assessed whether there were significant relationships between predictor variables and pretreatment goal selection .
RESULTS	Lower levels of alcohol-related consequences , lower readiness to change , higher family income , more daily drinkers in social network , and lack of prior treatment or Alcoholics Anonymous engagement predicted choice of a controlled drinking goal over a total abstinence goal .
RESULTS	Fewer alcohol-related consequences , lower readiness to change , and more daily drinkers in-network predicted choice of a conditional abstinence goal over a total abstinence goal .
CONCLUSIONS	Higher levels of functioning , lower levels of consequences , no prior involvement in treatment and Alcoholics Anonymous , and a more drinking-saturated social environment are associated with the choice of a non-abstinence goal .

###25308927
BACKGROUND	Compact and short pre-travel immunization schedules , which include several vaccinations in a single visit , are desirable for many travelers .
BACKGROUND	However , concomitant vaccination could potentially compromise immunogenicity and/or safety of the individual vaccines and , therefore , possible vaccine interferences should be carefully assessed .
BACKGROUND	This article discusses the immunogenicity and safety of travel vaccines for typhoid fever ( TF ) and yellow fever ( YF ) , when administered with or without a quadrivalent meningococcal glycoconjugate ACWY-CRM vaccine ( MenACWY-CRM ) .
METHODS	Healthy adults ( 18-60years ) were randomized to one of three vaccine regimens : TF+YF+M enACWY-CRM ( group I ; n = 100 ) , TF+YF ( group II ; n = 101 ) , or MenACWY-CRM ( group III ; n = 100 ) .
METHODS	Immunogenicity at baseline and 4weeks post-vaccination ( day 29 ) was assessed by serum bactericidal assay using human complement ( hSBA ) , enzyme-linked immunosorbent assay ( ELISA ) , or a neutralization test .
METHODS	Adverse events ( AEs ) and serious adverse events ( SAEs ) were collected throughout the study period .
RESULTS	Non-inferiority of post-vaccination geometric mean concentrations ( GMCs ) and geometric mean titers ( GMTs ) was established for TF and YF vaccines , respectively , when given concomitantly with MenACWY-CRM vaccine versus when given alone .
RESULTS	The percentages of subjects with seroprotective neutralizing titers against YF on day 29 were similar in groups I and II .
RESULTS	The antibody responses to meningococcal serogroups A , C , W-135 , and Y were within the same range when MenACWY-CRM was given separately or together with TF and YF vaccines .
RESULTS	The percentage of subjects reporting AEs was the same for TF and YF vaccines with or without MenACWY-CRM vaccine .
RESULTS	There were no reports of SAEs or AEs leading to study withdrawals .
CONCLUSIONS	These data provide evidence that MenACWY-CRM can be administered with typhoid Vi polysaccharide vaccine and live attenuated YF vaccine without compromising antibody responses stimulated by the individual vaccines .
CONCLUSIONS	MenACWY-CRM can , therefore , be incorporated into travelers ' vaccination programs without necessitating an additional clinic visit ( NCT01466387 ) .

###24827123
BACKGROUND	Treatment with escalated BEACOPP achieved a superior time to treatment failure over ABVD in patients with disseminated Hodgkin lymphoma .
BACKGROUND	However , recent clinical trials have failed to confirm BEACOPP overall survival ( OS ) superiority over ABVD .
BACKGROUND	In addition , the gain in low-risk patients is still a matter of debate .
METHODS	We randomly compared ABVD ( 8 cycles ) with BEACOPP ( escalated 4 cycles baseline 4 cycles ) in low-risk patients with an International Prognostic Score ( IPS ) of 0-2 .
METHODS	The primary end point was event-free survival ( EFS ) .
METHODS	This parallel group , open-label phase 3 trial was registered under #RECF 0219 at French National Cancer Institute .
RESULTS	One hundred and fifty patients were randomized in this trial ( ABVD 80 , BEACOPP 70 ) : 28 years was the median age , 50 % were male and IPS was 0-1 for 64 % .
RESULTS	Complete remission rate was 85 % for ABVD and 90 % for BEACOPP .
RESULTS	Progression or relapses were more frequent in the ABVD patients than in the BEACOPP patients ( 17 versus 5 patients ) .
RESULTS	With a median follow-up period of 5.5 years , seven patients died : six in the ABVD arm and one in the BEACOPP arm ( HL 3 and 0 , 2nd cancer 2 and 1 , accident 1 and 0 ) .
RESULTS	The EFS at 5 years was estimated at 62 % for ABVD versus 77 % , for BEACOPP [ hazards ratio ( HR ) = 0.6 , P = 0.07 ] .
RESULTS	The progression-free survival ( PFS ) at 5 years was 75 % versus 93 % ( HR = 0.3 , P = 0.007 ) .
RESULTS	The OS at 5 years was 92 % versus 99 % ( HR = 0.18 , P = 0.06 ) .
CONCLUSIONS	Fewer progressions/relapses were observed with BEACOPP , demonstrating the high efficacy of the more intensive regimen , even in low-risk patients .
CONCLUSIONS	However , additional considerations , balancing treatment-related toxicity and late morbidity due to salvage may help with decision-making with regard to treatment with ABVD or BEACOPP .

###24561392
OBJECTIVE	Lower levels of sex hormone-binding globulin ( SHBG ) have been associated with increased risk of diabetes among postmenopausal women ; however , it is unclear whether they are associated with glucose intolerance in younger women .
OBJECTIVE	We examined whether SHBG concentrations , measured before pregnancy , are associated with risk of gestational diabetes mellitus ( GDM ) .
METHODS	This was a nested case-control study among women who participated in the Kaiser Permanente Northern California Multiphasic Health Check-up examination ( 1984-1996 ) and had a subsequent pregnancy ( 1984-2009 ) .
METHODS	Eligible women were free of recognized diabetes .
METHODS	Case patients were 256 women in whom GDM developed .
METHODS	Two control subjects were selected for each case patient and were matched for year of blood draw , age at examination , age at pregnancy , and number of intervening pregnancies .
RESULTS	Compared with the highest quartile of SHBG concentrations , the odds of GDM increased with decreasing quartile ( odds ratio 1.06 [ 95 % CI 0.44-2 .52 ] ; 2.33 [ 1.07-5 .09 ] ; 4.06 [ 1.90-8 .65 ] ; P for trend < 0.001 ) , after adjusting for family history of diabetes , prepregnancy BMI , race/ethnicity , alcohol use , prepregnancy weight changes , and homeostasis model assessment of insulin resistance .
RESULTS	Having SHBG levels below the median ( < 64.5 nmol/L ) and a BMI 25.0 kg/m ( 2 ) was associated with fivefold increased odds of GDM compared with normal-weight women with SHBG levels at or above the median ( 5.34 [ 3.00-9 .49 ] ) .
CONCLUSIONS	Low prepregnancy SHBG concentrations were associated with increased risk of GDM and might be useful in identifying women at risk for GDM for early prevention strategies .

###25185471
OBJECTIVE	To determine whether charge awareness affects patient decisions .
BACKGROUND	Pediatric uncomplicated appendicitis can be treated with open or laparoscopic techniques .
BACKGROUND	These 2 operations are considered to have clinical equipoise .
METHODS	In a prospective , randomized clinical trial , nonobese children admitted to a children 's hospital with uncomplicated appendicitis were randomized to view 1 of 2 videos discussing open and laparoscopic appendectomy .
METHODS	Videos were identical except that only one presented the difference in surgical materials charges .
METHODS	Patients and parents then choose which operation they desired .
METHODS	Videos were available in English and Spanish .
METHODS	A postoperative survey was conducted to examine factors that influenced choice .
METHODS	The trial was registered at ClinicalTrials.gov ( NCT 01738750 ) .
RESULTS	Of 275 consecutive cases , 100 met enrollment criteria .
RESULTS	In the group exposed to charge data ( n = 49 ) , 63 % chose open technique versus 35 % not presented charge data ( P = 0.005 ) .
RESULTS	Patients were 1.8 times more likely to choose the less expensive option when charge estimate was given ( 95 % confidence interval , 1.17-2 .75 ) .
RESULTS	The median total hospital charges were $ 1554 less for those who had open technique ( P < 0.001 ) and $ 528 less for the group exposed to charge information ( P = 0.033 ) .
RESULTS	Survey found that 90 % of families valued having input in this decision and 31 % of patients exposed to charge listed it as their primary reason for their choice in technique .
CONCLUSIONS	Patients and parents tended to choose the less expensive but equally effective technique when given the opportunity .
CONCLUSIONS	A discussion of treatment options , which includes charge information , may represent an unrealized opportunity to affect change in health care spending .

###24433249
BACKGROUND	Patients with bipolar disorder experience sleep disturbance , even in euthymic phases .
BACKGROUND	Changes in sleep pattern are frequent signs of a new episode of ( hypo ) mania or depression .
BACKGROUND	Cognitive behavioral therapy for insomnia ( CBT-I ) is an effective treatment for primary insomnia , but there are no published results on the effects of CBT-I in patients with bipolar disorder .
BACKGROUND	In this randomized controlled trial , we wish to compare CBT-I and treatment as usual with treatment as usual alone to determine its effect in improving quality of sleep , stabilizing minor mood variations and preventing new mood episodes in euthymic patients with bipolar disorder and comorbid insomnia .
METHODS	Patients with euthymic bipolar I or II disorder and insomnia , as verified by the Structured Clinical Interview for DSM Disorders ( SCID-1 ) assessment , will be included .
METHODS	The patients enter a three-week run-in phase in which they complete a sleep diary and a mood diary , are monitored for seven consecutive days with an actigraph and on two of these nights with polysomnography in addition before randomization to an eight-week treatment trial .
METHODS	Treatment as usual consists of pharmacological and supportive psychosocial treatment .
METHODS	In this trial , CBT-I will consist of sleep restriction , psychoeducation about sleep , stabilization of the circadian rhythm , and challenging and correcting sleep state misperception , in three to eight sessions .
CONCLUSIONS	This trial could document a new treatment for insomnia in bipolar disorder with possible effects on sleep and on stability of mood .
CONCLUSIONS	In addition , more precise information can be obtained about the character of sleep disturbance in bipolar disorder .
BACKGROUND	ClinicalTrials.gov : NCT01704352 .

###24697278
OBJECTIVE	To prepare oral controlled-release cilostazol formulations and evaluate their pharmacokinetics and pharmacodynamics in dogs and humans compared with a commercial twice-daily immediate-release formulation ( Pletal ) , thereby showing the potential for the development of an improved once-daily cilostazol formulation .
METHODS	Six different controlled-release preparations were formulated using a micronized cilostazol , solubilizer/absorption enhancer and erodible hydrogel .
METHODS	In-vitro drug release profiles were tailored by varying hydrogel viscosity .
METHODS	Pharmacokinetics and pharmacodynamic ( antithrombotic ) efficacy were evaluated in beagle dog model of arterial thrombosis .
METHODS	Finally , their pharmacokinetics and pharmacodynamics were also evaluated in healthy human volunteers after single and multiple oral administrations .
RESULTS	Hydrogel viscosity-dependent sustained drug release profiles were observed with zero-order release kinetics during 8-12 h.
RESULTS	In dogs and humans , compared with Pletal , prolonged drug absorption profiles were observed in the two controlled-release formulations studied .
RESULTS	In dogs , the controlled-release formulations showed greater antithrombotic efficacy than twice-daily Pletal .
RESULTS	In humans , the antithrombotic efficacy of the selected once-daily cilostazol formulation was equivalent to that of twice-daily Pletal after single and multiple administrations .
CONCLUSIONS	The prepared oral controlled-release cilostazol formulation may provide prolonged drug absorption and sufficient therapeutic efficacy , potentially serving as an oral once-daily cilostazol formulation to improve patient compliance .

###25481340
BACKGROUND	Laryngeal tubes ( LT ) are often used as rescue airway devices .
BACKGROUND	Among prehospital medical personnel , the success rates are high and significantly faster compared to an endotracheal tube ( ETT ) .
BACKGROUND	Therefore , LTs are increasingly used in the prehospital setting .
BACKGROUND	The exchange of an LT for an ETT may often be desirable .
BACKGROUND	Two fiberoptic bronchoscope-facilitated techniques have been described to exchange an LT for an ETT : an intraluminal technique using an Aintree intubating catheter and an extraluminal technique using a nasal route alongside the LT. In this randomized cross-over mannequin study , we compared the intraluminal with the extraluminal exchange technique .
BACKGROUND	The primary outcome was time to achieve an effective airway through an ETT .
BACKGROUND	We hypothesized that the intraluminal technique would be significantly faster .
METHODS	Thirty anesthesia providers were recruited to the study .
METHODS	Each participant attempted both techniques in an intubation simulation model .
METHODS	The tube exchange time was recorded from picking up the fiberoptic bronchoscope until confirmation of ventilation with the ETT .
RESULTS	Four participants in each group had a failed attempt at intubation .
RESULTS	Time to establish an endotracheal intubation was significantly shorter with the intraluminal technique vs the extraluminal technique ( 77.5 vs 140 seconds ; P = .03 ) .
CONCLUSIONS	Based on the results of our study , we suggest that the intraluminal technique may be a suitable alternative for a fiberoptic-guided rapid exchange of an LT for an ETT to establish an effective airway in a challenging situation .

###25946099
OBJECTIVE	Driving is a vision-based activity of daily living that impacts safety .
OBJECTIVE	Because visual disruption can compromise driving safety , contact lens wearers with astigmatism may pose a driving safety risk if they experience residual blur from spherical lenses that do not correct their astigmatism or if they experience blur from toric lenses that rotate excessively .
OBJECTIVE	Given that toric lens stabilization systems are continually improving , this preliminary study tested the hypothesis that astigmats wearing toric contact lenses , compared with spherical lenses , would exhibit better overall driving performance and driving-specific visual abilities .
METHODS	A within-subject , single-blind , crossover , randomized design was used to evaluate driving performance in 11 young adults with astigmatism ( -0.75 to -1.75 diopters cylinder ) .
METHODS	Each participant drove a highly immersive , virtual reality driving simulator ( 210 degrees field of view ) with ( 1 ) no correction , ( 2 ) spherical contact lens correction ( ACUVUE MOIST ) , and ( 3 ) toric contact lens correction ( ACUVUE MOIST for Astigmatism ) .
METHODS	Tactical driving skills such as steering , speed management , and braking , as well as operational driving abilities such as visual acuity , contrast sensitivity , and foot and arm reaction time , were quantified .
RESULTS	There was a main effect for type of correction on driving performance ( p = 0.05 ) .
RESULTS	Correction with toric lenses resulted in significantly safer tactical driving performance than no correction ( p < 0.05 ) , whereas correction with spherical lenses did not differ in driving safety from no correction ( p = 0.118 ) .
RESULTS	Operational tests differentiated corrected from uncorrected performance for both spherical ( p = 0.008 ) and toric ( p = 0.011 ) lenses , but they were not sensitive enough to differentiate toric from spherical lens conditions .
CONCLUSIONS	Given previous research showing that deficits in these tactical skills are predictive of future real-world collisions , these preliminary data suggest that correcting low to moderate astigmatism with toric lenses may be important to driving safety .
CONCLUSIONS	Their merits relative to spherical lens correction require further investigation .

###24704800
BACKGROUND	Oncology patients with persistent pain treated in outpatient settings and their family caregivers have significant responsibility for managing pain medications .
BACKGROUND	However , little is known about their practical day-to-day experiences with pain medication management .
OBJECTIVE	The aim was to describe day-to-day pain medication management from the perspectives of oncology outpatients and their family caregivers who participated in a randomized clinical trial of a psychoeducational intervention called the Pro-Self ( ) Plus Pain Control Program .
OBJECTIVE	In this article , we focus on pain medication management by patients and family caregivers in the context of multiple complex health systems .
METHODS	We qualitatively analyzed audio-recorded intervention sessions that included extensive dialogue between patients , family caregivers , and nurses about pain medication management during the 10-week intervention .
RESULTS	The health systems context for pain medication management included multiple complex systems for clinical care , reimbursement , and regulation of analgesic prescriptions .
RESULTS	Pain medication management processes particularly relevant to this context were getting prescriptions and obtaining medications .
RESULTS	Responsibilities that fell primarily to patients and family caregivers included facilitating communication and coordination among multiple clinicians , overcoming barriers to access , and serving as a final safety checkpoint .
RESULTS	Significant effort was required of patients and family caregivers to insure safe and effective pain medication management .
CONCLUSIONS	Health systems issues related to access to needed analgesics , medication safety in outpatient settings , and the effort expended by oncology patients and their family caregivers require more attention in future research and health-care reform initiatives .

###25822100
BACKGROUND	The circadian clock coordinates numerous metabolic processes with light-dark and feeding regimens .
BACKGROUND	However , in humans it is unknown whether dietary patterns influence circadian rhythms .
OBJECTIVE	We examined the effects of switching from a high-carbohydrate , low-fat diet to a low-carbohydrate , high fat ( LC/HFD ) isocaloric diet on the central and peripheral circadian clocks in humans .
METHODS	Diurnal patterns of salivary cortisol and gene expression were analyzed in blood monocytes of 29 nonobese healthy subjects before and 1 and 6 weeks after the dietary switch .
METHODS	For this , we established a method of rhythm prediction by 3-time point data .
RESULTS	The centrally driven cortisol rhythm showed a phase delay 1 and 6 weeks after the dietary switch to a LC/HFD as well as an amplitude increase .
RESULTS	The dietary switch altered diurnal oscillations of core clock genes ( PER1 , PER2 , PER3 , and TEF ) and inflammatory genes ( CD14 , CD180 , NFKBIA , and IL1B ) .
RESULTS	The LC/HFD also affected the expression of nonoscillating genes contributing to energy metabolism ( SIRT1 ) and fat metabolism ( ACOX3 and IDH3A ) .
RESULTS	Expression of clock genes but not of salivary cortisol in monocytes tightly correlated with levels of blood lipids and with expression of metabolic and inflammatory genes .
CONCLUSIONS	Our results suggest that the modulation of the dietary fat and carbohydrate content alters the function of the central and peripheral circadian clocks in humans .

###25830422
BACKGROUND	Laparoscopic resection of colorectal cancer is widely used .
BACKGROUND	However , robust evidence to conclude that laparoscopic surgery and open surgery have similar outcomes in rectal cancer is lacking .
BACKGROUND	A trial was designed to compare 3-year rates of cancer recurrence in the pelvic or perineal area ( locoregional recurrence ) and survival after laparoscopic and open resection of rectal cancer .
METHODS	In this international trial conducted in 30 hospitals , we randomly assigned patients with a solitary adenocarcinoma of the rectum within 15 cm of the anal verge , not invading adjacent tissues , and without distant metastases to undergo either laparoscopic or open surgery in a 2:1 ratio .
METHODS	The primary end point was locoregional recurrence 3 years after the index surgery .
METHODS	Secondary end points included disease-free and overall survival .
RESULTS	A total of 1044 patients were included ( 699 in the laparoscopic-surgery group and 345 in the open-surgery group ) .
RESULTS	At 3 years , the locoregional recurrence rate was 5.0 % in the two groups ( difference , 0 percentage points ; 90 % confidence interval [ CI ] , -2.6 to 2.6 ) .
RESULTS	Disease-free survival rates were 74.8 % in the laparoscopic-surgery group and 70.8 % in the open-surgery group ( difference , 4.0 percentage points ; 95 % CI , -1.9 to 9.9 ) .
RESULTS	Overall survival rates were 86.7 % in the laparoscopic-surgery group and 83.6 % in the open-surgery group ( difference , 3.1 percentage points ; 95 % CI , -1.6 to 7.8 ) .
CONCLUSIONS	Laparoscopic surgery in patients with rectal cancer was associated with rates of locoregional recurrence and disease-free and overall survival similar to those for open surgery .
CONCLUSIONS	( Funded by Ethicon Endo-Surgery Europe and others ; COLOR II ClinicalTrials.gov number , NCT00297791 . )

###25390467
BACKGROUND	Early palliative care provides better quality of life , increased prognostic awareness , and even improved survival for patients with advanced cancer but how the integrated care model achieves these outcomes has not been completely explained .
METHODS	To better understand the clinical approach to early outpatient care from the clinicians ' perspective , we conducted focus groups with the palliative care clinicians who had participated in a randomized trial of early palliative care for metastatic lung cancer .
RESULTS	Clinicians described their role in providing early palliative care as having three distinct roles in the outpatient setting : ( 1 ) managing symptoms to improve functional status and as a bridge to other issues ; ( 2 ) engaging patients in emotional work to facilitate coping , accepting , and planning ; and ( 3 ) interpreting the oncologist for the patient and the patient for the oncologist .
CONCLUSIONS	These data lay the foundation for developing training programs for clinicians in early integrated palliative care .

###24987051
BACKGROUND	The National Institutes of Health.funded Trial to Assess Chelation Therapy ( TACT ) randomized 1708 stablecoronary disease patients aged .50 years who were .6 months post.myocardial infarction ( 2003.2010 ) to 40 infusions ofa multicomponent EDTA chelation solution or placebo .
BACKGROUND	Chelation reduced the primary composite end point of mortality , recurrent myocardial infarction , stroke , coronary revascularization , or hospitalization for angina ( hazard ratio , 0.82 ; 95 % confidence interval , 0.69.0.99 ; P = 0.035 ) .
RESULTS	In a randomly selected subset of 911 patients , we prospectively collected a battery of quality-of-life ( QOL ) instruments at baseline and at 6 , 12 , and 24 months after randomization .
RESULTS	The prespecified primary QOL measures were the Duke Activity Status Index ( Table I in the Data Supplement ) and the Medical Outcomes Study Short-Form 36 Mental Health Inventory-5 .
RESULTS	All comparisons were by intention to treat .
RESULTS	Baseline clinical and QOL variables were well balanced in the 451 patients randomized to chelation and in the 460 patients randomized to placebo .
RESULTS	The Duke Activity Status Index improved in both groups during the first 6 months of therapy , but we found no evidence for a treatment-related difference ( mean difference [ chelation.placebo ] during follow-up , 0.9 [ 95 % confidence interval , .0.7 to 2.6 ; P = 0.27 ] ) .
RESULTS	There was no statistically significant evidence of a treatment-related difference in the Mental Health Inventory-5 during follow-up ( mean difference , 1.0 ; 95 % confidence interval , .0.1 to 2.0 ; P = 0.08 ) .
RESULTS	None of the secondary QOL measures showed a consistent treatment-related difference .
CONCLUSIONS	In stable , predominantly asymptomatic coronary disease patients with a history of myocardial infarction , EDTA chelation therapy did not have a detectable effect on QOL during 2 years of follow-up .
BACKGROUND	URL : http://clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00044213 .

###24299497
BACKGROUND	Gait impairment is common in people with Parkinson 's disease .
BACKGROUND	There is a lack of effective interventions to target this debilitating complication and therefore a need to identify new therapeutic options .
BACKGROUND	An underlying cholinergic deficit contributes to both the gait and cognitive dysfunction seen in Parkinson 's disease .
BACKGROUND	The combined impact of both impairments can be assessed in gait tasks performed with concomitant cognitive tasks .
BACKGROUND	The aim of this trial is to evaluate the impact of a cholinesterase inhibitor on cognitive function and gait performance in people with established Parkinson 's disease .
METHODS	This is a single centre , double-blind , randomised placebo-controlled trial in 130 people with Hoehn and Yahr stage 2-3 idiopathic Parkinson 's disease who have fallen in the past year .
METHODS	Participants will be randomised to two groups , receiving either rivastigmine capsules or identical placebo capsules for 8months .
METHODS	Assessment will be undertaken at baseline and at the end of medication prescription ( i.e. 8months ) with participants remaining enrolled in the trial for a further 4months to monitor for falls and adverse events .
METHODS	The primary outcome is step time variability , assessed with and without the addition of concurrent cognitive tasks .
METHODS	Secondary outcomes will include other gait parameters , sensorimotor and balance performances , cognitive indices , falls and fall related injury , fear of falling , Parkinson 's symptoms and data pertaining to possible harms .
CONCLUSIONS	This randomised controlled trial will examine the effect of cholinesterase inhibitor therapy on gait , balance and falls in Parkinson 's disease .
CONCLUSIONS	If effective , it would offer a new therapeutic option to ameliorating gait and cognitive deficits in a population at high risk of falls .
BACKGROUND	ISRCTN19880883 , UTN U1111-1124-0244 .

###24908572
BACKGROUND	The impact of narrow band imaging in improving the adenoma detection rate in a screening scenario is still unclear .
OBJECTIVE	To evaluate whether narrow band imaging compared with high definition white light colonoscopy can enhance the adenoma detection rate during screening colonoscopy .
METHODS	Consecutive patients presenting for screening colonoscopy were included into this study and were randomly assigned to the narrow band imaging group ( Group 1 ) or standard colonoscopy group ( Group 2 ) .
METHODS	Primary end point was the adenoma detection rate and secondary aim was the detection rate of advanced adenomas .
RESULTS	Overall , 117 patients were allocated to Group 1 and 120 to Group 2 .
RESULTS	Both the adenoma detection rate and the detection rate of advanced adenomas were not significantly different between the two groups ( respectively , 52.1 % vs. 55 % , RR = 0.95 , 95 % CI 0.75-1 .20 ; 32.5 % vs. 44.2 % , RR = 0.74 , 95 % CI 0.53-1 .02 ) .
RESULTS	No significant difference between the proportions of polypoid and flat adenomas was found .
RESULTS	Male gender , no prior history of screening , and endoscopist 's adenoma detection rate were independent predictive factors of higher advanced adenoma detection rate .
CONCLUSIONS	In a screening scenario , narrow band imaging did not improve the adenoma nor advanced adenoma detection rates compared to high definition white light colonoscopy .

###24297945
OBJECTIVE	To prospectively determine the efficacy of combination therapy with temsirolimus plus bevacizumab versus interferon alfa ( IFN ) plus bevacizumab in metastatic renal cell carcinoma ( mRCC ) .
METHODS	In a randomized , open-label , multicenter , phase III study , patients with previously untreated predominantly clear-cell mRCC were randomly assigned , stratified by prior nephrectomy and Memorial Sloan-Kettering Cancer Center prognostic group , to receive the combination of either temsirolimus ( 25 mg intravenously , weekly ) or IFN ( 9 MIU subcutaneously thrice weekly ) with bevacizumab ( 10 mg/kg intravenously , every 2 weeks ) .
METHODS	The primary end point was independently assessed progression-free survival ( PFS ) .
RESULTS	Median PFS in patients treated with temsirolimus/bevacizumab ( n = 400 ) versus IFN/bevacizumab ( n = 391 ) was 9.1 and 9.3 months , respectively ( hazard ratio [ HR ] , 1.1 ; 95 % CI , 0.9 to 1.3 ; P = .8 ) .
RESULTS	There were no significant differences in overall survival ( 25.8 25.5 months ; HR , 1.0 ; P = .6 ) or objective response rate ( 27.0 % 27.4 % ) with temsirolimus/bevacizumab versus IFN/bevacizumab , respectively .
RESULTS	Patients receiving temsirolimus/bevacizumab reported significantly higher overall mean scores in the Functional Assessment of Cancer Therapy-Kidney Symptom Index ( FKSI ) -15 and FKSI-Disease Related Symptoms subscale compared with IFN/bevacizumab ( indicating improvement ) ; however , no differences in global health outcome measures were observed .
RESULTS	Treatment-emergent all-causality grade 3 adverse events more common ( P < .001 ) with temsirolimus/bevacizumab were mucosal inflammation , stomatitis , hypophosphatemia , hyperglycemia , and hypercholesterolemia , whereas neutropenia was more common with IFN/bevacizumab .
RESULTS	Incidence of pneumonitis with temsirolimus/bevacizumab was 4.8 % , mostly grade 1 or 2 .
CONCLUSIONS	Temsirolimus/bevacizumab combination therapy was not superior to IFN/bevacizumab for first-line treatment in clear-cell mRCC .

###24512953
BACKGROUND	Two arms with FOLFIRI , with or without cetuximab , were initially included in the randomized phase III intergroup clinical trial NCCTG ( North Central Cancer Treatment Group ) N0147 .
BACKGROUND	When other contemporary trials demonstrated no benefit to using irinotecan as adjuvant therapy , the FOLFIRI-containing arms were discontinued .
BACKGROUND	We report the clinical outcomes for patients randomized to FOLFIRI with or without cetuximab .
METHODS	After resection , patients were randomized to 12 biweekly cycles of FOLFIRI , with or without cetuximab .
METHODS	KRAS ( Kirsten rat sarcoma viral oncogene homolog ) mutation status was retrospectively determined in a central lab .
METHODS	The primary end point was disease-free survival ( DFS ) .
METHODS	Secondary end points included overall survival ( OS ) and toxicity .
RESULTS	One hundred and six patients received FOLFIRI and 40 received FOLFIRI plus cetuximab .
RESULTS	Median follow-up was 5.95 years ( range , 0.1-7 .0 years ) .
RESULTS	The addition of cetuximab showed a trend toward improved DFS ( hazard ratio [ HR ] , 0.53 ; 95 % CI , 0.26-1 .1 ; P = .09 ) and OS ( HR , 0.45 ; 95 % CI , 0.17-1 .16 ; P = .10 ) in the overall group , regardless of KRAS status , and in patients with wild type KRAS .
RESULTS	Grade 3 nonhematologic adverse effects were significantly increased in the cetuximab versus FOLFIRI-alone arm ( 68 % vs. 46 % ; P = .02 ) .
RESULTS	Adjuvant FOLFIRI resulted in a 3-year DFS less than that expected for FOLFOX .
CONCLUSIONS	In this small randomized subset of patients with resected stage III colon cancer , the addition of cetuximab to FOLFIRI was associated with a nonsignificant trend toward improved DFS and OS .
CONCLUSIONS	Nevertheless , considering the limitations of this analysis , FOLFOX without the addition of a biologic agent remains the standard of care for adjuvant therapy in resected stage III colon cancer .

###25323140
BACKGROUND	Severe depression can be a life-threatening disorder , especially in elderly patients .
BACKGROUND	A fast-acting treatment is crucial for this group .
BACKGROUND	Electroconvulsive therapy ( ECT ) may work faster than medication .
OBJECTIVE	To compare the speed of remission using ECT v. medication in elderly in-patients .
METHODS	The speed of remission in in-patients with a DSM-IV diagnosis of major depression ( baseline MADRS score 20 ) was compared between 47 participants ( mean age 74.0 years , s.d. = 7.4 ) from an ECT randomised controlled trial ( RCT ) and 81 participants ( mean age 72.2 years , s.d. = 7.6 ) from a medication RCT ( nortriptyline v. venlafaxine ) .
RESULTS	Mean time to remission was 3.1 weeks ( s.d. = 1.1 ) for the ECT group and 4.0 weeks ( s.d. = 1.0 ) for the medication group ; the adjusted hazard ratio for remission within 5 weeks ( ECT v. medication ) was 3.4 ( 95 % CI 1.9-6 .2 ) .
CONCLUSIONS	Considering the substantially higher speed of remission , ECT deserves a more prominent position in the treatment of elderly patients with severe depression .

###24841947
BACKGROUND	Parental language is associated with children 's later language development .
BACKGROUND	Parenting programmes , based on social learning theory , enhance a range of parenting behaviours , yet there is limited evidence for their effect on parental language .
OBJECTIVE	To assess the benefits of a behavioural-based parenting programme , which features components of language and communication , to enhance parental language .
METHODS	Parents of toddlers , aged 12 to 36 months , were recruited from eight Flying Start early intervention centres across Wales .
METHODS	Participants were randomised 2:1 either to a parenting programme ( n = 60 ) or to a wait-list control group ( n = 29 ) .
METHODS	Researchers were blind to participant allocation throughout the trial .
METHODS	Fifteen-minute video-recorded observations of parents and children interacting during free-play , both at a pre-intervention and at 6-month follow-up , provided the data for the study .
METHODS	Five observed measures of parental language were assessed ; quantity and variety , encouraging , critical , child-led and parent led interactions .
METHODS	The Incredible Years Parent-Toddler Programme ( IYPTP ) is a 12-week group-based behavioural intervention that teaches effective relationship and behavioural management skills including social , emotional and persistence coaching to enable parents to better support their children 's development .
RESULTS	Of 89 dyads that completed pre-intervention assessments 81 ( 54 intervention and 27 control ) met the criteria for the current study .
RESULTS	Intention to treat analysis indicated that child-led language interactions significantly benefited from the intervention [ regression coefficient ( B ) = -1.44 , 95 % confidence intervals ( CI ) = -2.59 to -0.29 , P = 0.015 , effect size ( ES ) = 0.47 ] and a positive trend for encouraging language in favour of the intervention sample was evident .
RESULTS	Per-protocol sample analysis replicated these findings with encouraging language reaching statistical significance ( B = 1.07 , 95 % CI = 0.11 to 2.03 , P = 0.03 , ES = 0.52 ) .
RESULTS	No further benefits were evident .
CONCLUSIONS	The IYPTP has limited evidence as an effective programme for enhancing some aspects of parental language .

###24492945
OBJECTIVE	The Radiation Therapy Oncology Group ( RTOG ) conducted a randomized , placebo-controlled trial evaluating the efficacy of GM-CSF in reducing mucosal injury and symptom burden from curative radiotherapy for head and neck ( H&N ) cancer .
METHODS	Eligible patients with H&N cancer receiving radiation encompassing 50 % of the oral cavity or oropharynx received subcutaneous GM-CSF or placebo .
METHODS	Quality of life ( QoL ) was assessed using the RTOG-modified University of Washington H&N Symptom Questionnaire at baseline 4 , 13 , 26 , and 48weeks from radiation initiation .
RESULTS	Of 125 eligible patients , 114 were evaluable for QoL ( 58 GM-CSF , 56 placebo ) .
RESULTS	Patient demographics , clinical characteristics , and baseline symptom scores were well balanced between the treatment arms .
RESULTS	At the end of the acute period ( 13weeks ) , patients in both arms reported negative change in total symptom score indicating increase in symptom burden relative to baseline ( mean -18.4 GM-CSF , -20.8 placebo ) .
RESULTS	There was no difference in change in total symptom score ( p > 0.05 ) or change in mucous , pain , eating , or activity domain scores ( p > 0.01 ) between patients in the GM-CSF and placebo arms .
RESULTS	Analysis limited to patients treated per protocol or with an acceptable protocol deviation also found no difference in change in total symptom score ( p > 0.05 ) or change in domain scores ( p > 0.01 ) between treatment arms .
RESULTS	Provider assessment of acute mucositis during treatment did not correlate with patient-reported mucous domain and total symptom scores ( p > 0.05 ) .
CONCLUSIONS	GM-CSF administered concurrently during head and neck radiation does not appear to significantly improve patient-reported QoL symptom burden .

###24440204
OBJECTIVE	This study sought to determine the impact that an electronic medical record ( EMR ) had on the provision of preventive health measures - including obtaining serologies for viral hepatitis and administering vaccinations to non-immune patients - to HIV patients at a hospital-based clinic .
METHODS	Using a pre-post study design , we compared rates of preventive health delivery to HIV patients at an outpatient clinic during the use of a paper medical record ( PMR ) and after implementation of an EMR .
METHODS	Retrospective chart reviews were conducted at two time points : 12-16 months prior to and 24 months following EMR implementation .
METHODS	The records of 160 active patients were randomly selected for review during both time periods .
RESULTS	There was no difference between the PMR and EMR samples with regard to the proportion of patients who had hepatitis A ( 83 % in PMR group ; 77 % in EMR ) and hepatitis C ( 94 % in both groups ) serologies measured or the proportion of eligible patients who were given hepatitis vaccinations .
RESULTS	Slightly fewer patients had a serology for hepatitis B measured in the EMR sample .
CONCLUSIONS	As EMR implementation expands , it is important to evaluate the effects that EMRs have on patient outcomes , including preventive health provision .
CONCLUSIONS	Our study showed that after implementation of an EMR , the provision of most preventive care measures did not improve .
CONCLUSIONS	This finding is in agreement with many published studies .
CONCLUSIONS	Some studies have found positive effects from EMRs that may be attributable to specific aspects of EMRs .
CONCLUSIONS	Further study of the effect of specific EMR attributes on health care outcomes is needed .

###25010882
OBJECTIVE	Fast-setting impression materials may be prone to inaccuracies due to accidental divergence from the recommended mixing protocol .
OBJECTIVE	This prospective randomized clinical trial aimed to assess three-dimensional ( 3D ) deviations in the reproduction of subgingival tooth surfaces and to determine the effect of either following or purposely diverging from the recommended mixing procedure for a fast-setting addition-curing silicone ( AS ) and fast-setting polyether ( PE ) .
METHODS	After three impressions each were taken from 96 participants , sawcut gypsum casts were fabricated with a standardized procedure and then optically digitized .
METHODS	Data were assessed with a computer-aided 3D analysis .
RESULTS	For AS impressions , multivariate analysis of variance revealed a significant influence of the individual tooth and the degree to which the recommended mixing protocol was violated .
RESULTS	For PE impressions , the ambient air temperature and individual tooth showed significant effects , while divergence from the recommended mixing protocol was not of significance .
CONCLUSIONS	The fast-setting PE material was not affected by changes in the recommended mixing protocol .
CONCLUSIONS	For the two fast-setting materials examined , no divergences from the recommended mixing protocol of less than 2 minutes led to failures in the reproduction of the subgingival tooth surfaces .

###25148231
BACKGROUND	The acute phase of the nonthyroidal illness syndrome ( NTIS ) is characterized by low T3 and high rT3 levels , affecting up to 75 % of critically ill patients .
BACKGROUND	Oxidative stress has been implicated as a causative factor of the disturbed peripheral thyroid hormone metabolism .
OBJECTIVE	The objective of the study was to investigate whether N-acetylcysteine ( NAC ) , a potent intracellular antioxidant , can prevent NTIS in patients with acute myocardial infarction .
METHODS	This was a randomized , multicenter clinical trial .
METHODS	Consecutive patients admitted to the emergency and intensive care units of two tertiary hospitals in southern Brazil were recruited .
METHODS	Patients and intervention included 67 patients were randomized to receive NAC or placebo during 48 hours .
METHODS	Baseline characteristics and blood samples for thyroid hormones and oxidative parameters were collected .
RESULTS	Variation of serum T3 and rT3 levels was measured .
RESULTS	Baseline characteristics were similar between groups ( all P > .05 ) .
RESULTS	T3 levels decreased in the placebo group at 12 hours of follow-up ( P = .002 ) but not in NAC-treated patients ( P = .10 ) .
RESULTS	Baseline rT3 levels were elevated in both groups and decreased over the initial 48 hours in the NAC-treated patients ( P = .003 ) but not in the control group ( P = .75 ) .
RESULTS	The free T4 and TSH levels were virtually identical between the groups throughout the study period ( P > .05 ) .
RESULTS	Measurement of total antioxidant status and total carbonyl content demonstrated that oxidative balance was deranged in acute myocardial infarction patients , whereas NAC corrected these alterations ( P < .001 ) .
CONCLUSIONS	NAC administration prevents the derangement in thyroid hormone concentrations commonly occurring in the acute phase of acute myocardial infarction , indicating that oxidative stress is involved in the NTIS pathophysiology .

###24861886
OBJECTIVE	The impetus of our study was to investigate the effects of a nutritional supplement Delphinol , an extract of maqui berries ( Aristotelia chilensis ) standardised to 25 % delphinidins and 35 % total anthocyanins , on postprandial blood glucose and insulin levels and identify the physiologic mechanism involved .
METHODS	Postprandial blood glucose and insulin were investigated in double-blind , placebo-controlled , cross-over fashion in ten volunteers with moderate glucose intolerance .
METHODS	Longer term effects on blood sugar levels were investigated in streptozotocin-diabetic rats over a four months period .
METHODS	Effects of maqui berry delphinidins on sodium-glucose symport were examined in rodent jejenum of the small intestine .
RESULTS	Delphinol intake prior to rice consumption statistical significantly lowered post prandial blood glucose and insulin as compared to placebo .
RESULTS	We identified an inhibition of Na + - dependant glucose transport by delphinidin , the principal polyphenol to which Delphinol is standardised .
RESULTS	In a diabetic rat model the daily oral application of Delphinol over a period of four months significantly lowered fasting blood glucose levels and reached values indistinguishable from healthy non-diabetic rats .
CONCLUSIONS	Our results suggest a potential use of Delphinol for naturally controlling post-prandial blood glucose owed to inhibition of sodium glucose co-transporter in small intestine .

###25727519
OBJECTIVE	To determine changes in spinal reflex excitability of the soleus and fibularis longus muscles before and after fibular taping intervention .
METHODS	Twenty-one individuals ( age = 23.4 2.7 y , height = 171.0 12.8 cm , mass = 69.7 11.8 kg ) with chronic ankle instability ( CAI ) and at least 5 ankle dorsiflexion asymmetry volunteered for this randomised crossover design study .
METHODS	Each participant received a fibular taping with tension or fibular taping without tension during separate sessions .
METHODS	Spinal reflex excitability of the soleus and fibularis longus was determined by obtaining maximum values for H-reflex ( Hoffmann reflex ) and maximum compound muscle action potential ( Mmax ) , which was expressed as a ratio ( H/M ratio ) .
METHODS	Measures were obtained immediately before and after a fibular taping intervention .
RESULTS	The application of tape to the fibula , regardless of tension , did not produce a change in spinal reflex excitability for the soleus ( F1 ,39 = .01 , P = .91 ) or fibularis longus ( F1 ,39 = .001 , P = .99 ) .
CONCLUSIONS	Fibular taping with and without tension did not result in an immediate change in spinal reflex excitability of the soleus or fibularis longus in individuals with CAI .
CONCLUSIONS	Although fibular taping has been shown to reduce recurrent ankle sprains in individuals with CAI , the mechanism of effectiveness may not involve an immediate increase in spinal reflex excitability .

###25437221
BACKGROUND	0.9 % saline is the most commonly used intravenous ( IV ) fluid in the world .
BACKGROUND	However , recent data raise the possibility that , compared with buffered crystalloid fluids such as Plasma-Lyte 148 , the administration of 0.9 % saline to intensive care unit patients might increase their risk of acute kidney injury ( AKI ) .
OBJECTIVE	To describe the protocol for the 0.9 % Saline v Plasma-Lyte 148 for ICU Fluid Therapy ( SPLIT ) study .
METHODS	This is a multicentre , cluster-randomised , double crossover feasibility study to be conducted in four New Zealand tertiary ICUs over a 28-week period and will enroll about 2300 participants .
METHODS	All ICU patients who need crystalloid IV fluid therapy ( except those with established renal failure needing dialysis and those admitted to the ICU for palliative care ) will be enrolled .
METHODS	Participating ICUs will be randomly assigned to 0.9 % saline or Plasma-Lyte 148 as the routine crystalloid IV fluid , in a blinded fashion , in four alternating 7-week blocks .
METHODS	The primary outcome will be the proportion of patients who develop AKI in the ICU .
METHODS	Secondary outcomes will include the difference between the most recent serum creatinine level measured before study enrollment and the peak serum creatinine level in the ICU ; use of renal replacement therapy ; and ICU and in hospital mortality .
METHODS	All analyses will be conducted on an intention-to-treat basis .
CONCLUSIONS	The SPLIT study started on 1 April 2014 and will provide preliminary data on the comparative effectiveness of using 0.9 % saline v Plasma - Lyte 148 as the routine IV fluid therapy in ICU patients .

###25421512
BACKGROUND	Effect sizes of pharmacotherapy in alcoholism are modest .
BACKGROUND	They might improve if subjects could be divided into more homogeneous subgroups and would then be treated targeted to their neurobiological profile .
BACKGROUND	In such an effort , we tested neural cue reactivity as a potential predictor of treatment response to naltrexone .
BACKGROUND	Alcohol-associated cues cause brain activations in mesocorticolimbic networks due to the positive reinforcing properties of alcohol .
BACKGROUND	These activations were reported to be associated with relapse behavior .
BACKGROUND	Naltrexone , an antagonist at the mu-opioid receptor , improves drinking behavior in some but not all patients probably by blocking the positive reinforcement of alcohol .
BACKGROUND	Conversely , acamprosate is proposed to modulate negative reinforcement ( withdrawal and cue-induced withdrawal ) .
BACKGROUND	Identifying subjects with elevated cue reactivity and testing their response to medical treatment could thus improve our understanding of some of the mechanisms underlying pharmacotherapy response .
METHODS	A picture-perception task featuring alcohol-related and neutral stimuli was presented to 64 recently detoxified alcohol-dependent patients .
METHODS	Patients came from 1 center of a larger double-blind randomized multicenter clinical trial ( the `` PREDICT Study '' ) .
METHODS	They were scanned prior to being randomized to either naltrexone or acamprosate .
METHODS	We examined the interaction between medication and functional magnetic resonance imaging ( fMRI ) cue reactivity , as measured by the percentage of voxels activated , using the time to the first severe relapse as the outcome criterion .
METHODS	Our a priori formulated hypothesis was that naltrexone but not acamprosate should be efficacious in subjects with high cue reactivity .
RESULTS	We observed an interaction effect between pretreatment brain activation induced by alcohol images and medication ( acamprosate/naltrexone ) on relapse behavior .
RESULTS	In line with our hypothesis , this interaction was driven by treatment response to naltrexone in patients with elevated pretreatment cue reactivity in the ventral striatum .
CONCLUSIONS	fMRI has the potential for predicting treatment response to naltrexone in a subgroup of alcohol-dependent patients .
CONCLUSIONS	However , this approach will be limited to researching the mechanisms and principles of treatment response .

###25073942
OBJECTIVE	This prospective randomised control study is to demonstrate whether or not there is a clinical benefit from inserting a Wallis implant on the functional recovery of patients who have undergone lumbar decompression surgery .
METHODS	Sixty consecutive patients with an average age of 58 years ( 34-81 ) who were selected for primary lumbosacral decompression were randomly assigned into two groups with equal number of patients , decompression alone or decompression with Wallis implant .
METHODS	The patients had an average follow-up of 40 months .
METHODS	Patients were assessed by visual analogue scale ( VAS ) ( Boonstra et al. , Int J Rehabil Res 31:165 -169 , 2008 ; Price et al. , Pain 17:45 -56 , 1983 ) pain score for back and leg pain , and the Oswestry Disability Index questionnaire ( ODI ) ( Smeets et al. , Arthritis Care Res ( Hoboken ) 63 : S158-S173 , 2011 ) .
RESULTS	The results in both the groups did not reveal a significant difference in the clinical outcome assessment of back pain score or ODI .
RESULTS	With the Wilcoxon two-sample test , no difference in median values was achieved ( p value 0.0787 for ODI and p value 0.1926 for back pain ) .
RESULTS	The average ODI in the Wallis group dropped from 50.93 to 29.11 .
RESULTS	The average VAS for the Wallis group back pain dropped from 7.79 to 4.22 .
CONCLUSIONS	The Wallis implant is a safe medical device .
CONCLUSIONS	This study revealed a reduction in pain and functional disability in patients treated with decompression surgery for lumbar stenosis , with or without Wallis .
CONCLUSIONS	The Wallis group improved more , but it was not statistically significant .
CONCLUSIONS	The risk of complications is lower than other interspinous devices .

###24229749
OBJECTIVE	To determine whether treatment of attention-deficit/hyperactivity disorder ( ADHD ) with osmotic-release oral system ( OROS ) methylphenidate promotes abstinence from smoking among smokers with ADHD who have greater severity of ADHD symptoms at baseline or greater improvement in ADHD during treatment .
METHODS	This is a secondary analysis of data from a randomized , double-blind , 11-week trial conducted between December 2005 and January 2008 at 6 clinical sites ; the original trial was sponsored by the National Drug Abuse Clinical Trials Network .
METHODS	Adult cigarette smokers ( aged 18-55 years ) who met DSM-IV criteria for ADHD were randomly assigned to OROS methylphenidate ( 72 mg/d ) ( n = 127 ) or matching placebo ( n = 128 ) .
METHODS	All participants received nicotine patches ( 21 mg/d ) and weekly individual smoking cessation counseling .
METHODS	Logistic regression was used to model prolonged abstinence from smoking ( ascertained by self-report and breath carbon monoxide testing ) as a function of treatment , baseline ADHD Rating Scale-IV ( ADHD-RS ) score , change in ADHD-RS score during treatment , and their interactions .
RESULTS	Treatment interacted with both ADHD-RS score at baseline ( P = .01 ) and change in ADHD-RS score during treatment ( P = .008 ) .
RESULTS	Among patients with higher ADHD-RS scores ( > 36 ) at baseline and the most improvement in ADHD during treatment ( ADHD-RS change score 24 ) , 70.0 % of those who took OROS methylphenidate achieved abstinence from smoking compared to 36.8 % of those who took placebo ( P = .02 ) .
RESULTS	In contrast , among patients with the lowest ADHD-RS baseline scores ( 30 ) , 30.3 % of those who took OROS methylphenidate achieved abstinence from smoking compared to 60.7 % of those who took placebo ( P = .02 ) .
CONCLUSIONS	OROS methylphenidate , in combination with nicotine patch , may be an effective treatment for nicotine dependence among smokers with more severe ADHD and more robust response of ADHD symptoms to medication .
CONCLUSIONS	OROS methylphenidate may be counterproductive among smokers with lower severity of ADHD .
BACKGROUND	ClinicalTrials.gov identifier : NCT00253747 .

###25973809
OBJECTIVE	We evaluated a school-based child sexual abuse ( CSA ) prevention program , Safe Touches , in a low-socioeconomic status , racially diverse sample .
METHODS	Participants were 492 second - and third-grade students at 6 public elementary schools in New York City .
METHODS	The study period spanned fall 2012 through summer 2014 .
METHODS	We cluster-randomized classrooms to the Safe Touches intervention or control groups and assessed outcomes with the Children 's Knowledge of Abuse Questionnaire .
METHODS	Hierarchical models tested change in children 's knowledge of inappropriate and appropriate touch .
RESULTS	The intervention group showed significantly greater improvement than the control group on knowledge of inappropriate touch .
RESULTS	Children in second grade and children in schools with a greater proportion of students in general ( vs special ) education showed greater gains than other participants in knowledge of inappropriate touch .
RESULTS	We observed no significant change in knowledge of appropriate touch among control or intervention groups .
CONCLUSIONS	Young children benefited from a school-based , 1-time CSA prevention program .
CONCLUSIONS	Future research should explore the efficacy of CSA prevention programs with children before the second grade to determine optimal age for participation .

###25611941
BACKGROUND	We examined the differential impact of a well-established human immunodeficiency virus ( HIV ) / sexually transmitted infections ( STIs ) curriculum , Be Proud !
BACKGROUND	Be Responsible !
BACKGROUND	, when taught by school nurses and health education classroom teachers within a high school curricula .
METHODS	Group-randomized intervention study of 1357 ninth and tenth grade students in 10 schools .
METHODS	Twenty-seven facilitators ( 6 nurses , 21 teachers ) provided programming ; nurse-led classrooms were randomly assigned .
RESULTS	Students taught by teachers were more likely to report their instructor to be prepared , comfortable with the material , and challenged them to think about their health than students taught by a school nurse .
RESULTS	Both groups reported significant improvements in HIV/STI/condom knowledge immediately following the intervention , compared to controls .
RESULTS	Yet , those taught by school nurses reported significant and sustained changes ( up to 12 months after intervention ) in attitudes , beliefs , and efficacy , whereas those taught by health education teachers reported far fewer changes , with sustained improvement in condom knowledge only .
CONCLUSIONS	Both classroom teachers and school nurses are effective in conveying reproductive health information to high school students ; however , teaching the technical ( eg , condom use ) and interpersonal ( eg , negotiation ) skills needed to reduce high-risk sexual behavior may require a unique set of skills and experiences that health education teachers may not typically have .

###24814500
BACKGROUND	Inflammation-induced pain amplification and hypersensitivity play a role in the pathophysiology of numerous clinical conditions .
BACKGROUND	Experimental endotoxemia has recently been implemented as model to analyze immune-mediated processes in human pain .
BACKGROUND	In this study , we aimed to analyze dose - and time-dependent effects of lipopolysaccharide ( LPS ) on clinically-relevant pain models for musculoskeletal and neuropathic pain as well as the interaction among LPS-induced changes in inflammatory markers , pain sensitivity and negative affect .
METHODS	In this randomized , double-blind , placebo-controlled study , healthy male subjects received an intravenous injection of either a moderate dose of LPS ( 0.8 ng/kg Escherichiacoli ) , low-dose LPS ( 0.4 ng/kg ) , or saline ( placebo control group ) .
METHODS	Pressure pain thresholds ( PPT ) , mechanical pain sensitivity ( MPS ) , and cold pain sensitivity ( CP ) were assessed before and 1 , 3 , and 6h post injection to assess time-dependent LPS effects on pain sensitivity .
METHODS	Plasma cytokines ( TNF - , IL-6 , IL-8 , IL-10 ) and state anxiety were repeatedly measured before , and 1 , 2 , 3 , 4 , and 6h after injection of LPS or placebo .
RESULTS	LPS administration induced a systemic immune activation , reflected by significant increases in cytokine levels , body temperature , and negative mood with pronounced effects to the higher LPS dose .
RESULTS	Significant decreases of PPTs were observed only 3h after injection of the moderate dose of LPS ( 0.8 ng/kg ) .
RESULTS	MPS and CP were not affected by LPS-induced immune activation .
RESULTS	Correlation analyses revealed that decreased PPTs were associated with peak IL-6 increases and negative mood .
CONCLUSIONS	Our results revealed widespread increases in musculoskeletal pain sensitivity in response to a moderate dose of LPS ( 0.8 ng/kg ) , which correlate both with changes in IL-6 and negative mood .
CONCLUSIONS	These data extend and refine existing knowledge about immune mechanisms mediating hyperalgesia with implications for the pathophysiology of chronic pain and neuropsychiatric conditions .

###24387919
OBJECTIVE	To assess the optimal scan delays and contrast injection durations for contrast-enhanced whole-body computed tomography ( CT ) .
METHODS	One hundred forty-two patients were randomized into three groups : protocol A-scan delay of 65 s after starting contrast injection over 30 s ; protocol B-105 and 70 s ; and protocol C-145 and 110 s , respectively .
METHODS	Contrast enhancement and diagnostic acceptability were assessed .
RESULTS	Qualitative assessment was subtle among the three protocols .
RESULTS	Homogenous enhancement of deep veins was more assuredly achieved with protocol C.
CONCLUSIONS	With protocol C , qualitatively acceptable enhancement can be obtained in whole-body CT. .

###25907158
BACKGROUND	Cardiorespiratory failure is the leading cause of death in Duchenne muscular dystrophy .
BACKGROUND	Based on preclinical and phase 2 evidence , we assessed the efficacy and safety of idebenone in young patients with Duchenne muscular dystrophy who were not taking concomitant glucocorticoids .
METHODS	In a multicentre phase 3 trial in Belgium , Germany , the Netherlands , Switzerland , France , Sweden , Austria , Italy , Spain , and the USA , patients ( age 10-18 years old ) with Duchenne muscular dystrophy were randomly assigned in a one-to-one ratio with a central interactive web response system with a permuted block design with four patients per block to receive idebenone ( 300 mg three times a day ) or matching placebo orally for 52 weeks .
METHODS	Study personnel and patients were masked to treatment assignment .
METHODS	The primary endpoint was change in peak expiratory flow ( PEF ) as percentage predicted ( PEF % p ) from baseline to week 52 , measured with spirometry .
METHODS	Analysis was by intention to treat ( ITT ) and a modified ITT ( mITT ) , which was prospectively defined to exclude patients with at least 20 % difference in the yearly change in PEF % p , measured with hospital-based and weekly home-based spirometry .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01027884 .
RESULTS	31 patients in the idebenone group and 33 in the placebo group comprised the ITT population , and 30 and 27 comprised the mITT population .
RESULTS	Idebenone significantly attenuated the fall in PEF % p from baseline to week 52 in the mITT ( -305 % p [ 95 % CI -708 to 097 ] , p = 0134 , vs placebo -901 % p [ -1318 to -484 ] , p = 00001 ; difference 596 % p [ 016 to 1176 ] , p = 0044 ) and ITT populations ( -257 % p [ -668 to 154 ] , p = 0215 , vs -884 % p [ -1273 to -495 ] , p < 00001 ; difference 627 % p [ 061 to 1193 ] , p = 0031 ) .
RESULTS	Idebenone also had a significant effect on PEF ( L/min ) , weekly home-based PEF , FVC , and FEV1 .
RESULTS	The effect of idebenone on respiratory function outcomes was similar between patients with previous corticosteroid use and steroid-naive patients .
RESULTS	Treatment with idebenone was safe and well tolerated with adverse event rates were similar in both groups .
RESULTS	Nasopharyngitis and headache were the most common adverse events ( idebenone , eight [ 25 % ] and six [ 19 % ] of 32 patients ; placebo , nine [ 26 % ] and seven [ 21 % ] of 34 patients ) .
RESULTS	Transient and mild diarrhoea was more common in the idebenone group than in the placebo group ( eight [ 25 % ] vs four [ 12 % ] patients ) .
CONCLUSIONS	Idebenone reduced the loss of respiratory function and represents a new treatment option for patients with Duchenne muscular dystrophy .
BACKGROUND	Santhera Pharmaceuticals .

###24702172
OBJECTIVE	To determine the influence of different volumes of resistance exercise on circulating interleukin-6 ( IL-6 ) and to explore the relationships between IL-6 and glycaemia .
METHODS	Eight participants with complication-free type 1 diabetes , whose mean SEM age was 38 ( 6 ) years , mean SEM HbA ( 1c ) concentration was 71 11 mmol/mol ( 8.7 1.0 % ) and mean SEM type 1 diabetes duration was 15 13 years , attended the research facility after an overnight fast on four separate occasions , having administered their basal insulin the night before ( glargine 27.53.1 U , n = 8 ) , but omitted morning rapid-acting insulin .
METHODS	Participants completed either a one-set ( 14-min ) , two-set ( 28-min ) , or three-set ( 42-min ) resistance exercise trial ( eight exercises 10 repetitions ) at 673 % one-repetition maximum followed by a 60-min recovery , or a resting control trial .
METHODS	Venous blood samples were taken before and after exercise .
METHODS	Data were analysed using repeated-measures ANOVA ( P0 .05 ) .
RESULTS	Whereas IL-6 levels remained similar to baseline levels after one set of resistance exercises ( 30 min , P = 0.287 ; 60 min , P = 0.318 ) , IL-6 levels were > baseline levels at 60 min post-exercise after a two-set exercise trial ( 2.94 0.94 pg/ml , P = 0.002 ) and doubled at both 30 min ( 4.01 1.00 pg/ml , P = 0.048 ) and 60 min ( 4.28 1.25 pg/ml , P = 0.084 ) post-exercise after the three-set resistance exercise trial .
RESULTS	Post-exercise blood glucose area under the curve ( mmol/l/60 min ) was greater after both the one-set ( P = 0.025 ) and two-set trials ( P = 0.008 ) , than after the control trial , but similar between the three-set trial and the control trial ( P = 0.240 ) .
RESULTS	The rise in IL-6 from baseline to peak concentration significantly correlated inversely with blood glucose area under the curve ( r = -0.65 , P = 0.041 ) .
CONCLUSIONS	Circulating IL-6 is increased by resistance exercise in a volume-dependent manner , and resistance exercise-induced increases in IL-6 correlated with reductions in post-exercise hyperglycaemia in type 1 diabetes , suggesting a role for IL-6 in improving post-resistance exercise glycaemic disturbances in type 1 diabetes .

###25946376
BACKGROUND	Ethnic minorities , especially African Americans and Latinos , bear a disproportionate burden of colorectal cancer ( CRC ) , as reflected in incidence , cancer stage , and mortality statistics .
BACKGROUND	In all ethnic groups , first-degree relatives ( FDRs ) of CRC cases are at an elevated disease risk .
BACKGROUND	However , underuse of CRC screening persists and is particularly evident among minority groups .
BACKGROUND	The current study tested a stepped intervention to increase CRC screening among an ethnically diverse sample of FDRs of CRC cases .
METHODS	A statewide cancer registry was used to recruit CRC cases and through them their FDRs .
METHODS	Relatives who were not current on CRC screening were randomized to intervention or usual-care control arms .
METHODS	The stepped intervention consisted of ethnically targeted and individually tailored print materials followed by telephone counseling for those unscreened at 6 months .
RESULTS	The study sample of 1280 individuals consisted of 403 Latino , 284 African American , 242 Asian , and 351 white FDRs .
RESULTS	Statistically significant effects were observed for the cumulative print plus telephone intervention at 12 months ( 26 % in the intervention vs 18 % in the control group ) and the print intervention alone at 6 months ( 15 % in the intervention vs 10 % in the control group ) .
RESULTS	The effect of the print intervention alone versus the cumulative interventions was not statistically significantly different .
RESULTS	Stratified analyses indicated that the intervention was effective among white , Latino , and Asian individuals , but not among African-Americans .
CONCLUSIONS	Overall , the intervention was effective in increasing screening rates .
CONCLUSIONS	Oversampling racial/ethnic minorities allowed for the examination of effects within subgroups , revealing no effect among African American individuals .
CONCLUSIONS	This finding illustrates the importance of including sufficient numbers of participants from diverse ethnic subgroups in intervention research to enable such stratified analyses .

###24363039
OBJECTIVE	To evaluate hip abductor strength-training for patients with unilateral transfemoral amputation .
METHODS	Single-blind , cross-over ( AB/BA ) trial with randomization .
METHODS	Seventeen patients with transfemoral amputation .
METHODS	Subjects completed 8-week programs of twice weekly hip abductor strength training or arm ergometry .
METHODS	Subjects were randomly assigned to receive either the experimental or active control intervention first .
METHODS	A physiotherapist blinded to group assignment conducted baseline and post-intervention assessments .
METHODS	The Timed Up & Go ( TUG ) test was selected as the primary outcome measure ; secondary measures included the 2 Minute Walk ( 2MW ) , hip abductor strength , Activities Specific Balance Confidence Scale ( ABC ) and prosthetic use .
METHODS	A two-way cross-over ANOVA was used for baseline and post-intervention treatment comparisons .
RESULTS	There were no baseline differences between treatments for TUG , 2MW , ABC , Houghton scale , sitting or side-lying abductor strength ( p > 0.05 for all ) , though supine strength was greater for the experimental treatment ( p < 0.05 ) .
RESULTS	After 8-weeks of hip abductor strength training , there were significant treatment effects for TUG , ABC ( p < 0.01 for both ) , 2MW ( p < 0.05 ) , sitting and side-lying abductor strength ( p = 0.05 for both ) , but not for supine strength , prosthetic use , nor thigh girth measures ( p > 0.05 for all ) .
CONCLUSIONS	This study suggests that patients with unilateral transfemoral amputation can improve functional performance and balance confidence following intense hip abductor strength training .

###26121894
BACKGROUND	Video-laryngoscopes have gained popularity in the recent years and have shown definite advantages over the conventional Macintosh direct laryngoscopes .
BACKGROUND	However , there is still insufficient evidence comparing the C-MAC with the Macintosh for patients during manual inline stabilization ( MILS ) .
METHODS	This prospective , randomized , single blind study was carried out to compare tracheal intubation using the C-MAC video-laryngoscope and Macintosh laryngoscope in patients during MILS .
METHODS	Ninety consented patients , without features of difficult airway , who required general anesthesia and tracheal intubation were recruited .
METHODS	Intubation was performed with either the C-MAC video-laryngoscope or the Macintosh laryngoscope by one single investigator experienced with both devices .
METHODS	Various parameters which included Cormack and Lehane score , time to intubate , intubation attempts , optimization maneuvers , complications and hemodynamic changes were recorded over the initial period of 5 minutes .
RESULTS	C-MAC video-laryngoscope performed significantly better with lower Cormack and Lehane grades , shorter time to intubate of 32.7 6.8 vs. 38.8 8.9 seconds ( p = 0.001 ) and needed less optimization maneuvers .
RESULTS	There were no significant differences seen in the intubation attempts , complications or hemodynamic status of the patients with either device .
CONCLUSIONS	The C-MAC video-laryngoscope was superior to the Macintosh laryngoscope for patients requiring intubation when manual inline neck stabilization was applied .

###25033263
OBJECTIVE	This study aimed to investigate the acute effect of intermittent walking exercise ( WE ) on blood pressure ( BP ) responses in patients with intermittent claudication ( IC ) .
OBJECTIVE	Secondly , this study aimed to gain improved insight into the physiological mechanisms controlling BP regulation after intermittent WE in this patient group .
METHODS	Twenty patients with IC participated in two experimental sessions in a random order , as follows : WE ( 15 2-min bouts of WE interpolated with 2-min rest intervals ) and control ( standing rest on a treadmill for 60 min ) .
METHODS	BP , cardiac output ( CO : CO2 rebreathing ) , and cardiovascular autonomic modulation ( spectral analysis of HR variability ) were assessed before and after both experimental sessions during supine rest , and stroke volume ( SV ) and systemic vascular resistance ( SVR ) were calculated .
METHODS	Data were analyzed using two-way ANOVA .
RESULTS	WE decreased systolic , diastolic , and mean BP , with net effects of -13 2 , -5 2 , and -7 2 mm Hg versus control , respectively ( all P < 0.05 ) .
RESULTS	WE also decreased SV ( -5.62 1.97 mL , P < 0.05 ) and CO ( -0.05 0.13 Lmin ( -1 ) , P < 0.05 ) versus preintervention and prevented the observed increase in SVR in the control condition ( +4.2 1.4 U , P < 0.05 ) .
RESULTS	HR showed a decrease ( P < 0.05 ) , consistent with evidence of increased vagal modulation , in the control condition .
RESULTS	BP measurements over the subsequent 24 h were similar between experimental conditions .
CONCLUSIONS	In patients with IC , WE induced a postexercise hypotension response that had a significant magnitude versus control but was not maintained over the next 24 h of daily activities .
CONCLUSIONS	The acute postexercise hypotension response was mediated by a decrease in CO and SV , which was not compensated by an augmentation of SVR , as observed in the control arm of the study .

###25244793
OBJECTIVE	To investigate the effects of recombinant human growth hormone on serum lipid in aged male patients with chronic heart failure ( CHF ) .
METHODS	Eighty seven patients with chronic heart failure ( > or = 60 years old ) were randomly divided into 2 groups : the CHF control group ( n = 46 ) who received regular therapy and the CHF experimental group ( n = 41 ) who received regular therapy and recombinant human growth hormone .
METHODS	The treatment would be continued for 3 months .
METHODS	Another group was normal control group ( n = 10 ) .
METHODS	The detection of serum growth hormone ( GH ) , insulin-like growth factor ( IGF-1 ) , total cholesterol ( TC ) , triglyceride ( TG ) , low-density lipoprotein cholesterol ( LDL-C ) , high density lipoprotein cholesterol ( HDL-C ) was carried out before and after treatment in the participants .
RESULTS	Before treatment , the levels of GH and IGF-1 were not significantly different among groups .
RESULTS	After treatment , the levels of GH ( 0.71 + / - 0.34 vs 0.96 + / - 0.48 ) and IGF-1 ( 95.64 + / - 21.11 vs 111.64 + / - 23.14 ) in CHF experimental group were higher than those before the treatment .
RESULTS	In CHF control group , the levels of GH ( 0.81 + / - 0.32 vs 0.79 + / - 0.29 ) and IGF-1 ( 97.82 + / - 19.74 vs 99.65 + / - 20.11 ) had no significant change after the treatment .
RESULTS	After treatment , the levels of GH ( 0.96 + / - 0.48 vs 0.79 + / - 0.29 ) and IGF-1 ( 111.64 + / - 23.14 vs 99.65 + / - 20.11 ) in CHF experimental group were higher compared with that of CHF control group .
RESULTS	Before treatment , the serum levels of LDL-C , HDL-C , TC and TG had no significant difference among groups .
RESULTS	After treatment , the levels of LDL-C ( 2.11 + / - 0.82 vs 1.76 + / - 0.51 ) and TC ( 3.78 + / - 1.34 vs 3.21 + / - 1.17 ) in CHF experimental group were lower than those before the treatment .
RESULTS	However , the levels of HDL-C ( 1.10 + / - 0.31 vs 0.99 + / - 0.28 ) and TG ( 1.89 + / - 1.07 vs 1.66 + / - 0.95 ) had no significant change after the treatment compared with before treatment .
RESULTS	In CHF control group , the serum lipid levels had no significant change after the treatment .
CONCLUSIONS	As the treatment of rhGH for aged male patients with chronic heart failure , GH influences lipid metabolism , which reduces the level of LDL-C , TC .
CONCLUSIONS	However GH has no effects on the serum HDL-C and TG level .
CONCLUSIONS	With the treatment of rhGH for long-term , lipid metabolism should be paid attention , and the treatment for blood lipid reduction should be adjusted in time .

###25254902
BACKGROUND	The purpose of this prospective , double-blinded , parallel-arm , randomized trial was to examine the effects of epidural bupivacaine on the length of the second stage of labor in nulliparous women .
METHODS	The authors assessed length of second-stage labor , degree of motor blockade , mode of delivery , and visual analog scores in 310 nulliparous women with labor epidurals randomized to receive either : ( 1 ) 0.125 % bupivacaine and fentanyl 2 g/ml or ( 2 ) fentanyl 10 g/ml alone via epidural using double blinding .
RESULTS	The median duration of the second stage was 75 min ( 41 , 128 ) in the bupivacaine/fentanyl group versus 73 min ( 42 , 120 ) in the fentanyl-only group ( P = 0.17 ) with a median difference of 6.0 ( 95 % CI , -6.0 to 18.0 ) .
RESULTS	Furthermore , there was no difference in degree of motor blockade , incidence of operative delivery , visual analog scores , or neonatal outcomes between the two groups .
RESULTS	No adverse events were reported .
CONCLUSIONS	Use of epidural bupivacaine/fentanyl or a fentanyl-only infusion during the second stage of labor did not affect the duration of the second stage of labor , degree of motor blockade , mode of delivery , pain relief , and maternal or neonatal outcomes .
CONCLUSIONS	However , in the fentanyl-only infusion group , there was a fivefold increase in opioid exposure to the fetus with unknown effects on neurobehavior , an outcome not assessed beyond the immediate postnatal period in this study .

###25775445
BACKGROUND	Botulinum toxin type A ( BoNT-A ) is widely used to improve the lower facial contour .
OBJECTIVE	To determine the difference in the changes in the lower facial contour achieved with 1 and 2 sessions of BoNT-A injections using 3-dimensional ( 3D ) laser scanning .
METHODS	Twenty volunteers were randomly divided into 2 groups .
METHODS	Group I ( n = 10 ) received a single injection , whereas Group II ( n = 10 ) received 2 sessions of injections , the second being administered 4 months after the first .
METHODS	Each injection comprised of 25 U of BoNT-A and was administered to the masseter muscle bilaterally .
METHODS	Evaluation of the effect of BoNT-A injection was performed using 3D laser scan images obtained before the injection and 6 months thereafter in Group I , and before the first injection and 6 months thereafter in the Group II .
RESULTS	The mean changes in the volume and thickness in Group I were -1,186 mm and -1.52 mm , respectively ; the corresponding changes were -4,072 mm and -3.84 mm in Group II .
RESULTS	The reductions were significantly greater in Group II than in Group I.
CONCLUSIONS	The administration of a second BoNT-A injection is effective for better aesthetic results for the lower facial contour .

###26237978
OBJECTIVE	To observe the clinical effect of acupuncture combined with neck-skin electrical stimulation ( NSES ) on dysphagia in patients with cerebral infarction ( CI ) .
METHODS	A total of 120 CI patients with dysphagia were randomly divided into acupuncture group , NSES group and acupuncture + NSES group ( combined treatment group , n = 40 in each group ) .
METHODS	Acupuncture stimulation of Fengchi ( GB20 ) , Yifeng ( TE 17 ) , etc. , and blood-letting of Jinjin ( EX-HN 12 ) and Yuye ( EX-HN 13 ) were administrated .
METHODS	NSES was applied to the bilateral sites of the neck-median line .
METHODS	The treatment was given once daily for two weeks .
METHODS	The swallow function and swallow dysfunction degree of the dysphasia patients were evaluated by water swallow test and food-intake scale , respectively .
RESULTS	After one week 's and two weeks ' treatment , the water swallow score and swallow dysfunction score were significantly improved in the acupuncture , NSES and combined treatment groups ( P < 0.01 ) , and the difference values between pre - and post-treatment of the water swallow score and swallow ability score in the combined treatment group were obviously higher than those of the acupuncture and NSES groups ( P < 0.01 , P < 0.05 ) .
RESULTS	No significant differences were found between the acupuncture and NSES groups in both the water swallow score and swallow ability score after one and two weeks ' treatment ( P > 0.05 ) .
RESULTS	Of the three 40 cases in the acupuncture , NSES and combined treatment groups , 16 , 18 and 27 were basically cured , 2 , 3 and 5 experienced marked improvement , 15 , 13 and 7 were improved , and 7 , 6 and 1 failed in the treatment , with the effective rates being 82.5 % , 85.0 % and 97.5 % , respectively .
RESULTS	The therapeutic effect of the combined treatment group was apparently superior to that of the simple acupuncture and simple NSES groups ( P < 0.01 ) .
CONCLUSIONS	Acupuncture and NSES intervention is effective in improving dysphasia in CI patients and the effect of combined treatment of acupuncture and NSES is obviously better than that of the simple acupuncture and simple NSES .

###25896330
BACKGROUND	Combustion-generated fine particulate matter ( PM2 .5 ) is associated with cardiovascular morbidity .
BACKGROUND	Both traffic-related air pollution and residential wood combustion may be important , but few studies have compared their impacts .
OBJECTIVE	To assess and compare effects of traffic-related and woodsmoke PM2 .5 on endothelial function and systemic inflammation ( C reactive protein , interleukin-6 and band cells ) among healthy adults in Vancouver , British Columbia , Canada , using high efficiency particulate air ( HEPA ) filtration to introduce indoor PM2 .5 exposure gradients .
METHODS	We recruited 83 healthy adults from 44 homes in traffic-impacted or woodsmoke-impacted areas to participate in this randomised , single-blind cross-over intervention study .
METHODS	PM2 .5 concentrations were measured during two consecutive 7-day periods , one with filtration and the other with ` placebo filtration ' .
METHODS	Endothelial function and biomarkers of systematic inflammation were measured at the end of each 7-day period .
RESULTS	HEPA filtration was associated with a 40 % decrease in indoor PM2 .5 concentrations .
RESULTS	There was no relationship between PM2 .5 exposure and endothelial function .
RESULTS	There was evidence of an association between indoor PM2 .5 and C reactive protein among those in traffic-impacted locations ( 42.1 % increase in C reactive protein per IQR increase in indoor PM2 .5 , 95 % CI 1.2 % to 99.5 % ) , but not among those in woodsmoke-impacted locations .
RESULTS	There were no associations with interleukin-6 or band cells .
CONCLUSIONS	Evidence of an association between C reactive protein and indoor PM2 .5 among healthy adults in traffic-impacted areas is consistent with the hypothesis that traffic-related particles , even at relatively low concentrations , play an important role in the cardiovascular effects of the urban PM mixture .
BACKGROUND	http://www.clinicaltrials.gov ( NCT01570062 ) .

###25372846
OBJECTIVE	Previous evidence has implicated corticostriatal abnormalities in the pathophysiology of psychosis .
OBJECTIVE	Although the striatum is the primary target of all efficacious antipsychotics , the relationship between its functional connectivity and symptomatic reduction remains unknown .
OBJECTIVE	To explore the longitudinal effect of treatment with second-generation antipsychotics on functional connectivity of the striatum during the resting state in patients experiencing a first episode of psychosis .
METHODS	This prospective controlled study took place at a clinical research center and included 24 patients with first-episode psychosis and 24 healthy participants matched for age , sex , education , and handedness .
METHODS	Medications were administered in a double-blind randomized manner .
METHODS	Patients were scanned at baseline and after 12 weeks of treatment with either risperidone or aripiprazole .
METHODS	Their symptoms were evaluated with the Brief Psychiatric Rating Scale at baseline and follow-up .
METHODS	Healthy participants were scanned twice within a 12-week interval .
METHODS	Functional connectivity of striatal regions was examined via functional magnetic resonance imaging using a seed-based approach .
METHODS	Changes in functional connectivity of these seeds were compared with reductions in ratings of psychotic symptoms .
RESULTS	Patients had a median exposure of 1 day to antipsychotic medication prior to being scanned ( mean [ SD ] = 4.5 [ 6.1 ] ) .
RESULTS	Eleven patients were treated with aripiprazole and 13 patients were treated with risperidone .
RESULTS	As psychosis improved , we observed an increase in functional connectivity between striatal seed regions and the anterior cingulate , dorsolateral prefrontal cortex , and limbic regions such as the hippocampus and anterior insula ( P < .05 , corrected for multiple comparisons ) .
RESULTS	Conversely , a negative relationship was observed between reduction in psychosis and functional connectivity of striatal regions with structures within the parietal lobe ( P < .05 , corrected for multiple comparisons ) .
CONCLUSIONS	Our results indicated that corticostriatal functional dysconnectivity in psychosis is a state-dependent phenomenon .
CONCLUSIONS	Increased functional connectivity of the striatum with prefrontal and limbic regions may be a biomarker for improvement in symptoms associated with antipsychotic treatment .

###26188742
BACKGROUND	Incisional hernia is a frequent complication of midline laparotomy and is associated with high morbidity , decreased quality of life , and high costs .
BACKGROUND	We aimed to compare the large bites suture technique with the small bites technique for fascial closure of midline laparotomy incisions .
METHODS	We did this prospective , multicentre , double-blind , randomised controlled trial at surgical and gynaecological departments in ten hospitals in the Netherlands .
METHODS	Patients aged 18 years or older who were scheduled to undergo elective abdominal surgery with midline laparotomy were randomly assigned ( 1:1 ) , via a computer-generated randomisation sequence , to receive small tissue bites of 5 mm every 5 mm or large bites of 1 cm every 1 cm .
METHODS	Randomisation was stratified by centre and between surgeons and residents with a minimisation procedure to ensure balanced allocation .
METHODS	Patients and study investigators were masked to group allocation .
METHODS	The primary outcome was the occurrence of incisional hernia ; we postulated a reduced incidence in the small bites group .
METHODS	We analysed patients by intention to treat .
METHODS	This trial is registered at Clinicaltrials.gov , number NCT01132209 and with the Nederlands Trial Register , number NTR2052 .
RESULTS	Between Oct 20 , 2009 , and March 12 , 2012 , we randomly assigned 560 patients to the large bites group ( n = 284 ) or the small bites group ( n = 276 ) .
RESULTS	Follow-up ended on Aug 30 , 2013 ; 545 ( 97 % ) patients completed follow-up and were included in the primary outcome analysis .
RESULTS	Patients in the small bites group had fascial closures sutured with more stitches than those in the large bites group ( mean number of stitches 45 [ SD 12 ] vs 25 [ 10 ] ; p < 00001 ) , a higher ratio of suture length to wound length ( 50 [ 15 ] vs 43 [ 14 ] ; p < 00001 ) and a longer closure time ( 14 [ 6 ] vs 10 [ 4 ] min ; p < 00001 ) .
RESULTS	At 1 year follow-up , 57 ( 21 % ) of 277 patients in the large bites group and 35 ( 13 % ) of 268 patients in the small bites group had incisional hernia ( p = 00220 , covariate adjusted odds ratio 052 , 95 % CI 031-087 ; p = 00131 ) .
RESULTS	Rates of adverse events did not differ significantly between groups .
CONCLUSIONS	Our findings show that the small bites suture technique is more effective than the traditional large bites technique for prevention of incisional hernia in midline incisions and is not associated with a higher rate of adverse events .
CONCLUSIONS	The small bites technique should become the standard closure technique for midline incisions .
BACKGROUND	Erasmus University Medical Center and Ethicon .

###24576514
BACKGROUND	A major limitation of primary percutaneous coronary intervention ( PPCI ) for the treatment of ST-elevation myocardial infarction ( STEMI ) is impaired microvascular perfusion due to embolization and obstruction of microcirculation with thrombus .
BACKGROUND	Manual thrombectomy has the potential to reduce distal embolization and improve microvascular perfusion .
BACKGROUND	Clinical trials have shown mixed results regarding thrombectomy .
OBJECTIVE	The objective of this study is to evaluate the efficacy of routine upfront manual aspiration thrombectomy during PPCI compared with percutaneous coronary intervention alone in patients with STEMI .
METHODS	This is a multicenter , prospective , open , international , randomized trial with blinded assessment of outcomes .
METHODS	Patients with STEMI undergoing PPCI are randomized to upfront routine manual aspiration thrombectomy with the Export catheter ( Medtronic CardioVascular , Santa Rosa , CA ) or to percutaneous coronary intervention alone .
METHODS	The primary outcome is the composite of cardiovascular death , recurrent myocardial infarction , cardiogenic shock , or new or worsening New York Heart Association class IV heart failure up to 180 days .
METHODS	The trial uses an event-driven design and will recruit 10,700 patients .
CONCLUSIONS	The TOTAL trial will determine the effect of routine manual aspiration thrombectomy during PPCI on clinically important outcomes .

###24655814
BACKGROUND	Improving adherence to ocular hypertension ( OH ) / glaucoma therapy is highly likely to prevent or reduce progression of optic nerve damage .
BACKGROUND	The present study used a behaviour change counselling intervention to determine whether education and support was beneficial and cost-effective in improving adherence with glaucoma therapy .
METHODS	A randomised controlled trial with a 13-month recruitment and 8-month follow-up period was conducted .
METHODS	Patients with OH/glaucoma attending a glaucoma clinic and starting treatment with travoprost were approached .
METHODS	Participants were randomised into two groups and adherence was measured over 8 months , using an electronic monitoring device ( Travalert dosing aid , TDA ) .
METHODS	The control group received standard clinical care , and the intervention group received a novel glaucoma education and motivational support package using behaviour change counselling .
METHODS	Cost-effectiveness framework analysis was used to estimate any potential cost benefit of improving adherence .
RESULTS	Two hundred and eight patients were recruited ( 102 intervention , 106 control ) .
RESULTS	No significant difference in mean adherence over the monitoring period was identified with 77.2 % ( CI , 73.0 , 81.4 ) for the control group and 74.8 % ( CI , 69.7 , 79.9 ) for the intervention group ( p = 0.47 ) .
RESULTS	Similarly , there was no significant difference in percentage intraocular pressure reduction ; 27.6 % ( CI , 23.5 , 31.7 ) for the control group and 25.3 % ( CI , 21.06 , 29.54 ) for the intervention group ( p = 0.45 ) .
RESULTS	Participants in the intervention group were more satisfied with information about glaucoma medication with a mean score of 14.47 / 17 ( CI , 13.85 , 15.0 ) compared with control group which was 8.51 ( CI , 7.72 , 9.30 ) .
RESULTS	The mean intervention cost per patient was GB10 .35 ( < US$ 16 ) and not cost-effective .
CONCLUSIONS	Adherence with travoprost was high and not further increased by the intervention .
CONCLUSIONS	Nevertheless , the study demonstrated that provision of information , tailored to the individual , was inexpensive and able to achieve high patient satisfaction with respect to information about glaucoma medication .
CONCLUSIONS	Measurement of adherence remains problematic since awareness of study participation may cause a change in participant behaviour .
BACKGROUND	Current Controlled Trials , ISRCTN89683704 .

###24433230
BACKGROUND	Progress towards MDG4 for child survival in South Africa requires effective prevention of mother-to-child transmission ( PMTCT ) of HIV including increasing exclusive breastfeeding , as well as a new focus on reducing neonatal deaths .
BACKGROUND	This necessitates increased focus on the pregnancy and early post-natal periods , developing and scaling up appropriate models of community-based care , especially to reach the peri-urban poor .
METHODS	We used a randomised controlled trial with 30 clusters ( 15 in each arm ) to evaluate an integrated , scalable package providing two pregnancy visits and five post-natal home visits delivered by community health workers in Umlazi , Durban , South Africa .
METHODS	Primary outcomes were exclusive and appropriate infant feeding at 12 weeks post-natally and HIV-free infant survival .
RESULTS	At 12 weeks of infant age , the intervention was effective in almost doubling the rate of exclusive breastfeeding ( risk ratio 1.92 ; 95 % CI : 1.59-2 .33 ) and increasing infant weight and length-for-age z-scores ( weight difference 0.09 ; 95 % CI : 0.00-0 .18 , length difference 0.11 ; 95 % CI : 0.03-0 .19 ) .
RESULTS	No difference was seen between study arms in HIV-free survival .
RESULTS	Women in the intervention arm were also more likely to take their infant to the clinic within the first week of life ( risk ratio 1.10 ; 95 % CI : 1.04-1 .18 ) .
CONCLUSIONS	The trial coincided with national scale up of ARVs for PMTCT , and this could have diluted the effect of the intervention on HIV-free survival .
CONCLUSIONS	We have demonstrated that implementation of a pro-poor integrated PMTCT and maternal , neonatal and child health home visiting model is feasible and effective .
CONCLUSIONS	This trial could inform national primary healthcare reengineering strategies in favour of home visits .
CONCLUSIONS	The dose effect on exclusive breastfeeding is notable as improving exclusive breastfeeding has been resistant to change in other studies targeting urban poor families .

###24495042
BACKGROUND	The NCIC CTG/AGITG CO. 17 trial demonstrated that cetuximab monotherapy improved overall and progression-free survival ( OS and PFS ) in patients previously treated for advanced colorectal cancer .
BACKGROUND	A strong relationship was observed between benefit from cetuximab and development of rash .
BACKGROUND	In this analysis , the association of rash and benefit from cetuximab is explored and presented by KRAS mutation status .
METHODS	Rash was graded by NCI CTC 2.0 criteria .
METHODS	Landmark analysis was performed by excluding patients who died or dropped out within 28 days and then grouping by worst grade of rash experienced by day 28 .
METHODS	Multivariate Cox models were conducted separately for patients with KRAS wild-type ( WT ) tumours and KRAS mutated ( MUT ) tumours .
METHODS	CO. 17 primary outcome was OS .
RESULTS	Development of grade 2 + rash on cetuximab was associated with a trend towards increased OS ( HR 0.61 with 95 % CI 0.36-1 .02 and p = 0.06 ) and PFS ( HR 0.68 with 95 % CI 0.45-1 .03 and p = 0.07 ) as compared to grade 0/1 rash in patients with WT tumours .
RESULTS	In patients with WT tumours on cetuximab both grade 0/1 and grade 2 + rash were associated with increased PFS ( HR 0.57 95 % CI 0.38-0 .86 ; p = 0.008 ; and HR 0.32 95 % CI 0.21-0 .49 ; p < 0.0001 ) respectively , in comparison with best supportive care ( BSC ) .
RESULTS	Only development of grade 2 + rash on cetuximab was associated with increased OS ( HR 0.52 with 95 % CI 0.34-0 .80 and p = 0.003 ) in comparison with BSC .
RESULTS	No significant difference was found in OS or PFS among patients on cetuximab with MUT tumours with either rash grade as compared to BSC .
RESULTS	No consistent trend was observed for the association of severity of rash and quality of life ( QoL ) .
CONCLUSIONS	As all patients with WT tumours benefitted to some extent from cetuximab regardless of the grade of rash , grade of rash was not a useful predictive marker .

###25630353
OBJECTIVE	To compare quality-of-life ( QoL ) outcomes over 2 years following initiation of treatment with a standard or newer antiepileptic drug ( AED ) in adults with new-onset epilepsy .
OBJECTIVE	To examine the impact of seizure remission and failure of initial treatment on QoL outcomes measured over 2 years .
METHODS	We conducted a pragmatic , randomized , unblinded , multicenter , parallel-group clinical trial ( the Standard and New Antiepileptic Drugs [ SANAD ] trial ) comparing clinical and cost effectiveness of initiating treatment with carbamazepine versus lamotrigine , gabapentin , oxcarbazepine and topiramate , and valproate versus lamotrigine and topiramate .
METHODS	QoL data were collected by mail at baseline , 3 months , and at 1 and 2 years using validated measures .
METHODS	These data were analyzed using longitudinal data models .
METHODS	Continuous QoL measures , time to 12-month remission and time to treatment withdrawal were explored using joint models .
RESULTS	Baseline questionnaires were returned by 1,575 adults ; 1,439 returned the 3-month questionnaire , 1,274 returned the 1-year questionnaire , and 1,121 returned the 2-year questionnaire .
RESULTS	There were few statistically significant differences between drugs over 2 years in QoL outcomes .
RESULTS	Significant association was identified between QoL scores over the 2-year time frame and the risk of experiencing a 12-month remission or treatment withdrawal over that period .
CONCLUSIONS	The choice of initial treatment had no significant effect on QoL by 2-year follow-up .
CONCLUSIONS	However , overall QoL was reduced with continued seizures , adverse events , and failure of the initial treatment .

###25033582
BACKGROUND	Ocular blood flow ( OBF ) disturbances could be involved both in the pathogenesis and in progression of glaucomatous damage .
OBJECTIVE	The aim of the study was to compare the retrobulbar hemodynamic parameters in the ophthalmic artery ( OA ) , central retinal artery ( CRA ) and short posterior cilliary arteries ( SPCA ) after decreasing the elevated intraocular pressure ( IOP ) in primary open-angle glaucoma ( POAG ) patients by using color Doppler imaging ( CDI ) .
METHODS	We examined 60 patients ( 21 male and 39 female ) with diagnosed and treated POAG .
METHODS	Thirty-nine patients had increased IOP ( > 25 mm Hg ) .
METHODS	Peak-systolic velocity ( PSV ) , end-diastolic velocity ( EDV ) , Pourcelot resistance index ( RI ) , and pulsatility index ( PI ) were assessed in the OA , CRA , and SPCA .
METHODS	IOP was measured both with the Goldmann Applanation tonometer ( GAT ) and with the Dynamic Contour tonometer ( DCT ) , three times respectively .
METHODS	Ocular pulse amplitude ( OPA ) was measured using DCT .
RESULTS	The retrobulbar parameters between the baseline and after IOP reduction showed no difference in measurements .
RESULTS	After Bonferroni correction ( p < or = 0.0056 , alpha/9 ) statistical significance was recorded only in the following retrobulbar hemodynamic parameters ; DCT ( 29.8 + / - 6.2 vs. 15.5 + / - 5.0 ) , GAT ( 33.8 + / - 9.0 vs. 15.0 + / - 6.6 ) and OPA measurements ( 4.3 + / - 1.0 vs. 3.0 + / - 1.6 ) , as compared to the baseline .
RESULTS	There was no correlation between the changes in IOP measured with either DCT or GAT and changes in the hemodynamic parameters ( p > 0.05 for all ) .
RESULTS	Pearson correlation coefficient ( 95 % CI ) showed very good correlation for IOP measurements between DCT and GAT : at baseline 0.83 ( 0.71 to 0.90 ) and at the end 0.71 ( 0.55 to 0.83 ) ; p < 0.0001 for both measurements , but without any difference between them ( p > 0.05 ) .
CONCLUSIONS	There was a lack of correlation between the changes in IOP measured with either DCT or GAT and the changes in the hemodynamic parameters .

###24472873
OBJECTIVE	Guidelines for administering amino acids to critically ill children are largely based on uncontrolled observational studies and expert opinion , without support from rigorous outcome studies .
OBJECTIVE	Also , data on circulating amino acid concentrations during critical illness are scarce .
OBJECTIVE	We thoroughly studied the time profiles of circulating amino acid concentrations in critically ill children who received standard nutritional care according to international guidelines .
METHODS	This is a subanalysis of pediatric critically ill patients included in a large ( n = 700 ) randomized controlled study on intensive insulin therapy .
METHODS	The study was conducted at a university hospital PICU .
METHODS	We studied 100 patients in PICU for at least 3 days following cardiac surgery .
METHODS	Patients were assigned to intensive insulin therapy targeting normal-for-age fasting blood glucose concentrations or insulin infusion only to prevent excessive hyperglycemia .
RESULTS	Plasma amino acid concentrations were measured at admission , day 3 , and day 7 in PICU .
RESULTS	At admission , the concentrations of most amino acids were comparable to those reported for healthy children .
RESULTS	Total amino acid concentrations remained stable during ICU stay , but individual amino acids showed different time profiles with eight of them showing an increase and five a decrease .
RESULTS	Nonsurviving children had higher total amino acid concentrations and individual amino acids compared with survivors at admission and/or during ICU stay .
RESULTS	Intensive insulin therapy lowered the concentrations of total amino acids and several individual amino acids .
RESULTS	Neonates showed somewhat different amino acid profiles with rather increased concentrations from baseline with time in ICU for total amino acids and several individual amino acids as compared with older infants and children .
CONCLUSIONS	Circulating amino acid concentrations in critically ill children after cardiac surgery differ according to survival status , blood glucose control with intensive insulin therapy , and age .

###25818061
OBJECTIVE	Bupropion was tested for efficacy to achieve methamphetamine ( MA ) abstinence in dependent , non-daily users .
METHODS	A randomized , double-blind , placebo-controlled trial , with 12-week treatment and 4-week follow-up , was conducted with 204 treatment-seeking participants having MA dependence per DSM-IV , who used MA on a less-than-daily basis .
METHODS	104 were randomized to matched placebo and 100 to bupropion , sustained-release 150mg , twice daily .
METHODS	Participants were seen three times weekly to obtain urine for MA and bupropion assays , study assessments , and thrice weekly , 90-min , group psychotherapy .
METHODS	There was no biomarker for placebo adherence .
METHODS	The primary outcome was achievement of abstinence throughout the last two weeks of treatment ; ` success ' requiring at least two urine samples during each of Weeks 11 and 12 , and all samples MA-negative ( < 300ng/mL ) .
RESULTS	Bupropion and placebo groups did not differ significantly in the percentage achieving abstinence for the last 2 weeks of treatment ( chi-square , p = 0.32 ) .
RESULTS	Subgroup analysis of participants with lower baseline MA use ( 18 of last 30 days before consent ) also revealed no difference in success between groups ( p = 0.73 ) .
RESULTS	Medication adherence per protocol ( detectable bupropion , > 5ng/mL , in 50 % of urine samples from Study Weeks 1-10 and 66 % of urine samples from Weeks 11 to 12 ) was achieved by 47 % of participants taking bupropion .
CONCLUSIONS	These data indicate that bupropion did not increase abstinence in dependent participants who were using MA less-than-daily .
CONCLUSIONS	Medication non-adherence was a limitation in this trial .
CONCLUSIONS	Psychosocial therapy remains the mainstay of treatment for MA dependence .
CONCLUSIONS	Further research on subgroups who may respond to bupropion may be warranted .

###24620386
OBJECTIVE	To observe the protective effect of Xuebijing injection pretreatment on hepatic ischemia reperfusion ( I/R ) injury and coagulopathy in liver cancer patients undergoing excision of hepatic cancer after occlusion of hepatic blood flow .
METHODS	A prospective randomly controlled study was conducted .
METHODS	Sixty patients with liver cancer classified as Child-Pugh class A undergoing hepatectomy in the Department of Hepatobiliary Surgery of Sun Yat-sen University Cancer Center from October 2011 to March 2013 were enrolled .
METHODS	The patients were randomized into control group and Xuebijing group ( each patient received 100 mL Xuebijing injection added to 0.9 % saline as a preoperative treatment for 3 days ) .
METHODS	Complete blood count , coagulation function , hepatic function , serum pro-inflammatory cytokines and alpha-fetoprotein ( AFP ) levels were determined before and after operation .
RESULTS	Forty-five out of 60 patients were enrolled eventually , with 23 patients in control group and 22 in Xuebijing group , and among them 43 patients were positive for hepatitis B surface antigen ( HBsAg ) at admission .
RESULTS	Compared with those before operation , the postoperative levels of alanine transaminase ( ALT ) , aspartate transaminase ( AST ) and lactate dehydrogenase ( LDH ) in control and Xuebijing groups were significantly elevated , prothrombin time ( PT ) and activated partial prothrombin time ( AfYIT ) were significantly prolonged , and white blood cells ( WBC ) , proportion of neutrophils ( N ) and C-reactive protein ( CRP ) were significantly increased ( P < 0.05 or P < 0.01 ) .
RESULTS	Although the above indexes in Xuebijing group after operation were lower than those in control group in different degrees [ ALT ( U/L ) : 213.1 ( 80.4-796 .6 ) vs. 265.8 ( 15.6-882 .3 ) , AST ( UIL ) : 194.1 ( 65.4-914 .2 ) vs. 264.3 ( 15.4-475 .9 ) , LDH ( lg , U/L ) : 5.69 0.72 vs. 5.71 0.72 , PT ( s ) : 15.24 2.16 vs. 14.41 1.33 , AfYIT ( s ) : 31.51 7.04 vs. 29.47 4.90 , WBC ( x 109/L ) : 13.4 7 4.66 vs. 14.58 4.40 , N : 0.87 0.06 vs. 0.87 0.04 , CRP ( mg/L ) : 40.64 ( 16.93-189 .59 ) vs. 45.64 ( 1.65-349 .40 ) J , no statistical significance was found between the groups ( all P > 0.05 ) .
RESULTS	The preoperative levels of tumor necrosis factor-a ( TNF - a ) and interleukin-6 OL-6 ) were both less than 1.0 ng/L , and the postoperative levels of TNF-a showed no significant change , and IL-6 was increased to 485.10 ( 104.00-837 .50 ) ng/L and 193.26 ( 95.10-385 .20 ) ng/L in control and Xuebijing groups respectively ( P < 0.01 ) .
RESULTS	The serum high mobility group box-1 ( HMGB1 ) protein levels after operation were higher than those of preoperative in both groups ( both P < 0.01 ) , but the postoperative HMGB1 in Xuebijing group were significantly lower than those in control group ( j.Lg / L : 268.73 5.56 vs. 277.12 2.92 , P < 0.01 ) .
RESULTS	Acute physiology and chronic health evaluation ll ( APACHE ll ) score in Xuebijing group was significantly lower than that in control group ( 4.18 3.75 vs. 4.53 2.34 , t = 5.328 , P = 0.027 ) , and the first passage of flatus and defecation after operation in Xuebijing group were significantly earlier than those in control group [ exhaust time ( days ) : 3 ( 2-4 ) vs. 3 ( 2-4 ) , U = -2.023 , P = 0.043 ; defecation time ( days ) : 4 ( 2-6 ) vs. 5 ( 3-8 ) , U = -2.926 , P = 0.003 J. However , no difference was found between two groups in the postoperative and total hospital days .
RESULTS	Spearman rank correlation analysis showed there were positive correlations between hepatitis B virus ( HBV ) - DNA levels and preoperative ALT ( r = 0.414 , P = 0.044 ) and AST ( r = 0.405 , P = 0.024 ) in 33 HBV-DNA positive patients , but there was no significant correlation between HBV - DNA levels or other preoperative liver function indicators .
CONCLUSIONS	Hepatic I/R injury and coagulopathy may occur in liver cancer patients undergoing resection of cancer with occlusion of hepatic blood flow .
CONCLUSIONS	Xuebijing injection may inhibit the release of serum pro-inflammatory cytokines , thereby alleviate hepatic I/R injury and promote the recovery of intestinal function .
CONCLUSIONS	But it does not offer protective effect on coagulopathy .

###25060690
OBJECTIVE	Muscle and fat are now recognized as metabolism-regulating endocrine organs .
OBJECTIVE	However , muscle and adipocyte-derived novel cytokines such as irisin and omentin-1 remain understudied in relation to metabolic biomarkers that are associated with cardiovascular risk .
METHODS	Thirty-nine subjects with mean ( SD ) BMI of 29.2 5.4 kg/m ( 2 ) and either diabetes or two other cardiovascular risk factors were enrolled in a 6-month randomized trial of low-dose ethanol .
METHODS	We examined cross-sectional data at baseline , 3-month , and 6-month visits to assess ( 1 ) within-person stability of novel cytokines ( irisin , omentin-1 , visfatin , resistin , and soluble tumor necrosis factor receptor II ) and ( 2 ) their associations with metabolic parameters , particularly lipoprotein subparticle profile .
RESULTS	Repeated measures of irisin and omentin-1 were highly correlated , with intra-class correlations of 0.84 ( 95 % CI : 0.74 , 0.91 ; P < 0.001 ) and 0.81 ( 0.70 , 0.89 ; P < 0.001 ) , respectively .
RESULTS	Irisin was negatively correlated with omentin-1 ( 7.4 % irisin decrease per a 1-SD increment in omentin-1 ; 95 % CI : 0.5 % , 13.9 % ; P = 0.04 ) .
RESULTS	In models adjusted for age , sex , and race , irisin was negatively associated with HDL cholesterol ( 7.3 % decrease per a 10mg/dL increment ; 1.0 % , 13.3 % ; P = 0.02 ) and large HDL particles ( 15.5 % decrease per a 1-SD or 3.5-mol / L increment ; 5.2 % , 24.7 % ; P = 0.005 ) .
RESULTS	Omentin-1 was positively associated with mean VLDL size ( 3.8 % increase per a 1-SD increment ; 0.06 % , 7.8 % ; P = 0.05 ) .
RESULTS	Adjustment for alcohol intervention , BMI , and other cytokines did not materially affect these associations .
CONCLUSIONS	Irisin and omentin-1 are stable within-person , inversely associated with each other , and closely related to lipoprotein profile .
CONCLUSIONS	These molecules may be promising markers for cardiovascular risk .

###24740408
OBJECTIVE	Epistaxis is a common complication of nasal intubation .
OBJECTIVE	Ease of insertion of the tracheal tube may be influenced by bevel orientation and tip bending .
OBJECTIVE	We examined ease of insertion and epistaxis with two tubes with different orientations and with or without a stylet to modify tip bending .
METHODS	Two hundred patients scheduled to undergo oral or maxillofacial surgery were randomized into four groups according to method of nasal intubation used after induction of anesthesia .
METHODS	In one group , a Portex ( ) tracheal tube was inserted with bevel facing left ( Portex Group ) .
METHODS	In the second group , a Parker Flex-Tip ( ) tube ( Parker Group ) was inserted with the bevel facing posteriorly , and in the last two groups , a stylet bent at 60 anteriorly was used with the Portex tube ( Stylet-Portex Group ) or Parker tube ( Stylet-Parker Group ) .
METHODS	When the tube advanced without resistance , insertion was defined as `` smooth '' , and when resistance was encountered , insertion was defined as `` impinged '' .
METHODS	Severity of epistaxis was evaluated as none , mild , moderate , or severe .
RESULTS	Smooth insertion was observed in 60 % of patients in the Portex Group ; 80 % in the Parker Group ; 100 % in the Stylet-Portex Group ; and 100 % in the Stylet-Parker Group .
RESULTS	Epistaxis was found in 50 % , 24 % , 20 % , and 4 % of patients , respectively .
RESULTS	The styletted tip ( difference : 30 % ; 95 % confidence interval [ CI ] : 20.3 to 38.5 ; P < 0.0001 ) was found to improve ease of insertion .
RESULTS	Both the posterior-facing bevel ( difference : 21 % ; 95 % CI : 9.0 to 32.1 ; P = 0.0005 ) and stylet ( difference : 25 % ; 95 % CI : 13.1 to 35.9 ; P < 0.0001 ) contributed significantly to absence of epistaxis .
CONCLUSIONS	Using a styletted tracheal tube with a posterior-facing bevel improves ease of insertion through the nasopharynx and decreases the severity of epistaxis during nasal intubation .
BACKGROUND	UMIN Clinical Trials Registry ( UMIN-CTR ) , UMIN000011327 .

###24655702
BACKGROUND	Rapid blood pressure ( BP ) control improves dyspnea in hypertensive acute heart failure ( AHF ) .
BACKGROUND	Although effective antihypertensives , calcium-channel blockers are poorly studied in AHF .
BACKGROUND	Clevidipine is a rapidly acting , arterial selective intravenous calcium-channel blocker .
BACKGROUND	Our purpose was to determine the efficacy and safety of clevidipine vs standard-of-care intravenous antihypertensive therapy ( SOC ) in hypertensive AHF .
METHODS	This is a randomized , open-label , active control study of clevidipine vs SOC in emergency department patients with AHF having systolic BP 160 mm Hg and dyspnea 50 on a 100-mm visual analog scale ( VAS ) .
METHODS	Coprimary end points were median time to , and percent attaining , a systolic BP within a prespecified target BP range ( TBPR ) at 30 minutes .
METHODS	Dyspnea reduction was the main secondary end point .
RESULTS	Of 104 patients ( mean [ SD ] age 61 [ 14.9 ] years , 52 % female , 80 % African American ) , 51 received clevidipine and 53 received SOC .
RESULTS	Baseline mean ( SD ) systolic BP and VAS dyspnea were 186.5 ( 23.4 ) mm Hg and 64.8 ( 19.6 ) mm .
RESULTS	More clevidipine patients ( 71 % ) reached TBPR than did those receiving SOC ( 37 % ; P = .002 ) , and clevidipine was faster to TBPR ( P = .0006 ) .
RESULTS	At 45 minutes , clevidipine patients had greater mean ( SD ) VAS dyspnea improvement than did SOC patients ( -37 [ 20.9 ] vs -28 mm [ 21.7 ] , P = .02 ) , a difference that remained significant up to 3 hours .
RESULTS	Serious adverse events ( 24 % vs 19 % ) and 30-day mortality ( 3 vs 2 ) were similar between clevedipine and SOC , respectively , and there were no deaths during study drug administration .
CONCLUSIONS	In hypertensive AHF , clevidipine safely and rapidly reduces BP and improves dyspnea more effectively than SOC .

###24705022
BACKGROUND	Nonadherence and medication errors are common among patients with complex drug regimens .
BACKGROUND	Apps for smartphones and tablets are effective for improving adherence , but they have not been tested in elderly patients with complex chronic conditions and who typically have less experience with this type of technology .
OBJECTIVE	The objective of this study was to design , implement , and evaluate a medication self-management app ( called ALICE ) for elderly patients taking multiple medications with the intention of improving adherence and safe medication use .
METHODS	A single-blind randomized controlled trial was conducted with a control and an experimental group ( N = 99 ) in Spain in 2013 .
METHODS	The characteristics of ALICE were specified based on the suggestions of 3 nominal groups with a total of 23 patients and a focus group with 7 professionals .
METHODS	ALICE was designed for Android and iOS to allow for the personalization of prescriptions and medical advice , showing images of each of the medications ( the packaging and the medication itself ) together with alerts and multiple reminders for each alert .
METHODS	The randomly assigned patients in the control group received oral and written information on the safe use of their medications and the patients in the experimental group used ALICE for 3 months .
METHODS	Pre and post measures included rate of missed doses and medication errors reported by patients , scores from the 4-item Morisky Medication Adherence Scale ( MMAS-4 ) , level of independence , self-perceived health status , and biochemical test results .
METHODS	In the experimental group , data were collected on their previous experience with information and communication technologies , their rating of ALICE , and their perception of the level of independence they had achieved .
METHODS	The intergroup intervention effects were calculated by univariate linear models and ANOVA , with the pre to post intervention differences as the dependent variables .
RESULTS	Data were obtained from 99 patients ( 48 and 51 in the control and experimental groups , respectively ) .
RESULTS	Patients in the experimental group obtained better MMAS-4 scores ( P < .001 ) and reported fewer missed doses of medication ( P = .02 ) .
RESULTS	ALICE only helped to significantly reduce medication errors in patients with an initially higher rate of errors ( P < .001 ) .
RESULTS	Patients with no experience with information and communication technologies reported better adherence ( P < .001 ) , fewer missed doses ( P < .001 ) , and fewer medication errors ( P = .02 ) .
RESULTS	The mean satisfaction score for ALICE was 8.5 out of 10 .
RESULTS	In all , 45 of 51 patients ( 88 % ) felt that ALICE improved their independence in managing their medications .
CONCLUSIONS	The ALICE app improves adherence , helps reduce rates of forgetting and of medication errors , and increases perceived independence in managing medication .
CONCLUSIONS	Elderly patients with no previous experience with information and communication technologies are capable of effectively using an app designed to help them take their medicine more safely .
BACKGROUND	Clinicaltrials.gov NCT02071498 ; http://clinicaltrials.gov/ct2/show/NCT02071498 .

###24341093
OBJECTIVE	To discuss the effect and safety of preventive administration of antibiotics to patients with benign prostatic hyperplasia ( BPH ) before urodynamic examination .
METHODS	A total of 256 BPH patients to undergo urodynamic examination were randomly divided into a control group ( n = 118 ) and a trial group ( n = 138 ) .
METHODS	The former received no pre-treatment while the latter were given cefoxitin sodium iv at 1.0 g 30 minutes before complete urodynamic examination .
METHODS	Then we compared the incidence rates of urinary tract infection between the two groups .
RESULTS	Statistically significant differences were found in the incidence rate of urinary tract infection between the control and trial groups ( 20.3 % [ 24/118 ] vs 7.3 % [ 10/138 ] , P < 0.01 ) , as well as in those with diabetes mellitus ( 6.7 % [ 3/45 ] vs 23.5 % [ 8/34 ] , P < 0.05 ) , those with residual urine > 50 ml ( 5.4 % [ 3/56 ] vs 18.5 % [ 10/54 ] , P < 0.05 ) , and those with both diabetes mellitus and residual urine ( 9.5 % [ 2/21 ] vs 44.4 % [ 8/18 ] , P < 0.05 ) .
RESULTS	Only 3 patients ( 2.2 % ) in the trial group had mild adverse drug reactions .
CONCLUSIONS	For BPH patients , particularly those with diabetes mellitus and residual urine , preventive administration of antibiotics before urodynamic examination is safe and can effectively protect the patients against urinary tract infection .

###24494282
OBJECTIVE	To assess the clinical efficacy of acupuncture pretreatment for the prevention of stroke based on promoting the circulation of the Governor Vessel and regulating mentality , and explore its effect mechanism .
METHODS	Seventy cases of transient ischemic attack ( TIA ) were randomized into an acupuncture group ( 35 cases ) and a western medicine group ( 35 cases ) .
METHODS	In the acupuncture group , acupuncture therapy of promoting the circulation of the Governor Vessel and regulating mentality was applied at Yaoyangguan ( GV 3 ) , Mingmen ( GV 4 ) , Zhiyang ( GV 9 ) , Shenzhu ( GV 12 ) , Dazhui ( GV 14 ) , Yamen ( GV 15 ) , Fengfu ( GV 16 ) , Baihui ( GV 20 ) and Neck-Jiaji ( EX-B 2 ) .
METHODS	Acupuncture was given 6 times a week , at the interval of one day between two weeks .
METHODS	Totally , 21 days of treatment were taken as a session .
METHODS	In the western medicine group , aspirin enteric coated tablets were prescribed , 25 mg/tablet , 100 mg/day , once a night for oral administration , and 21 days of medication were taken as 1 session .
METHODS	There were 3 days at the interval between two sessions in each group and totally 2 sessions were required .
METHODS	Transcranial Doppler ( TCD ) was adopted before treatment and in two sessions of treatment to observe , mean flow velocity ( Vm ) of middle cerebral artery ( MCA ) , vertebral artery ( VA ) , basilar arte ry ( BA ) and pulsatility index ( PI ) .
METHODS	The standard of the efficacy assessment of stroke aura was taken as the main efficacy index in the assessment of theraputic effect , the adverse reaction was observed .
RESULTS	1In TIA , MCA blood flow was accelerated in internal carotid system , and BA blood flow was accelerated in vertebral-basilar artery system .
RESULTS	The treatments in the two groups enabled the blood flow in the responsible blood vessels slow down and the results in the acupuncture group L ( 60.54 + / -11.76 ) cm/s , ( 36.17 + / -8.65 ) cm/s ] were better than those in the western medicine group [ ( 72.34 + / -9.15 ) cm/s , ( 65.23 + / -8.99 ) cm/s ] ( P < O. 05 ) .
RESULTS	2The results of clinical efficacy and adverse reactions in the acupuncture group [ 96.77 % ( 30/31 ) ,6.45 % ( 2/31 ) ] were superior to the western medicine group [ 75.76 % ( 25/33 ) ,45.46 % ( 15/33 ) ] ( both P < 0.05 ) .
RESULTS	3Concerning to the recurrence of disease at the different period after treatment , the case number of cerebral infarction was not different significantly between the two groups ( P > 0.05 ) .
CONCLUSIONS	Acupuncture intervention based on promoting the circulation of the Governor Vessel and regulating mentality achieves the superior efficacy on TIA and less adverse reactions as compared with aspirin .
CONCLUSIONS	The effect mechanism is related potentially to the improvement of cerebral vascular hemodynamic .

###25163103
BACKGROUND	Persons with severe and persistent mental disorders ( SPMD ) have extremely low earnings levels and account for 29.1 percent of all U.S. Social Security Disability Income ( SSDI ) disabled worker beneficiaries under age 50 .
BACKGROUND	Social insurance and disability policy experts pointed to several factors that may contribute to this situation , including disincentives and obstacles in the SSDI program , as well as lack of access to evidence-based behavioral-health interventions .
BACKGROUND	In response , the Social Security Administration ( SSA ) funded the Mental Health Treatment Study ( MHTS ) demonstration that included 2,238 beneficiaries of SSDI whose primary reason for disability is SPMD .
BACKGROUND	The demonstration , implemented in 23 different localities , consisted of two evidence-based services ( individual placement and support supported employment ( IPS-SE ) , systematic medication management ( SMM ) ) , and provision or coverage of additional behavioral-health services ( OBH ) .
OBJECTIVE	This study focused on estimating MHTS intervention effects on earnings in the intervention period ( two-years ) .
OBJECTIVE	The main outcome variable was self-reported average monthly earnings .
METHODS	Subjects were randomly assigned to intervention or control groups .
METHODS	Data were drawn from the baseline survey , seven follow-up quarterly surveys , a final follow-up survey , and SSA administrative data .
METHODS	In all surveys , respondents were asked about earnings prior to the interview .
METHODS	Dependent variables were average past-30-days earnings reported in all follow-up surveys , similar averages for the first four follow-ups and for the last four follow-ups , fraction of surveys with prior earnings above SSA 's substantial gainful activity ( SGA ) threshold , and final-follow-up earnings for the past 90 days .
METHODS	Regression analyses compared earnings of intervention vs. control group subjects .
METHODS	Covariates included baseline values of : ( i ) beneficiary demographic and social characteristics ; ( ii ) beneficiary physical and mental health indicators ; ( iii ) beneficiary recipiency history ; ( iv ) beneficiary pre-recruitment and baseline earnings ; and ( v ) local labor-market unemployment rates .
RESULTS	Results show significant positive MHTS earnings impacts .
RESULTS	Estimated annual increases of earnings range from USD791 ( based on the 2-year average ) to USD1 ,131 ( based on the final quarter of Year 2 ) .
RESULTS	Effects on the fraction of quarters with earnings exceeding SGA are positive and significant but very small in magnitude .
CONCLUSIONS	The consistent increase in earnings impacts over the study period suggests the possibility of even larger impacts with longer-term interventions .
CONCLUSIONS	The moderate size of the intervention impacts may partly be explained by a study population that already had an average of 9 years on SSDI , and whose labor-supply decisions continued to be affected by concerns about possible loss of benefits .
CONCLUSIONS	Limitations are that ( i ) earnings effects of specific intervention components can not be estimated since all treatment subjects received the same package of services , and ( ii ) study results may not generalize to the majority of the beneficiary population due to selection effects in beneficiaries ' participation decisions .
CONCLUSIONS	Replication of the MHTS on a broader scale should show similar positive earnings impacts for a substantial number of beneficiaries with characteristics similar to the study population .
CONCLUSIONS	Future studies should consider reducing policy barriers to labor supply of persons with SPMD .
CONCLUSIONS	Future studies should consider longer-term interventions , or at least measuring impacts for follow-up periods greater than two years .

###25674254
OBJECTIVE	To evaluate the feasibility and effectiveness of a telemedicine system based on internet in the follow-up of patients with type 2 diabetes mellitus ( T2DM ) .
METHODS	A prospective randomized telemedicine study with two parallel groups was designed .
METHODS	114 patients diagnosed T2DM were randomly divided into telemedicine group and traditional face-to-face visit group as control .
METHODS	57 cases were included for each group .
METHODS	108 patients completed the trial , in which 53 cases in telemedicine group and 55 cases in control group .
METHODS	Patients in telemedicine group were taught to use telemedicine software to upload their blood glucose and other metabolic information at home at least every 2 weeks , and the researchers gave proper advices according to patients ' key behaviors .
METHODS	The telemedicine interval is 3 months .
RESULTS	Compared to control group , telemedicine group exhibited better HbA1c and fasting blood glucose controlling ( P < 0.05 ) .
RESULTS	Moreover , telemedicine intervention decreased hypoglycemia risk ( P = 0.044 ) , and contributed to levels of HbA1c less than 7 % which is the target of our study ( P = 0.049 ) .
CONCLUSIONS	Telemedicine system can provide a tighter glycemic control for the treatment of T2DM patients , especially in cases with difficulties to access to the medical centre .

###25188444
OBJECTIVE	Staging for liver fibrosis is recommended in the management of hepatitis C as an argument for treatment priority .
OBJECTIVE	Our aim was to construct a noninvasive algorithm to predict the significant liver fibrosis ( SLF ) using common biochemical markers and compare it with some existing models .
METHODS	The study group included 104 consecutive cases ; SLF was defined as Ishak fibrosis stage greater than 2 .
METHODS	The patient population was assigned randomly to the training and the validation groups of 52 cases each .
METHODS	The training group was used to construct the algorithm from parameters with the best predictive value .
METHODS	Each parameter was assigned a score that was added to the noninvasive fibrosis score ( NFS ) .
METHODS	The accuracy of NFS in predicting SLF was tested in the validation group and compared with APRI , FIB4 , and Forns models .
RESULTS	Our algorithm used age , alkaline phosphatase , ferritin , APRI , 2 macroglobulin , and insulin and the NFS ranged from -4 to 5 .
RESULTS	The probability of SLF was 2.6 versus 77.1 % in NFS < 0 and NFS > 0 , leaving NFS = 0 in a gray zone ( 29.8 % of cases ) .
RESULTS	The area under the receiver operating curve was 0.895 and 0.886 , with a specificity , sensitivity , and diagnostic accuracy of 85.1 , 92.3 , and 87.5 % versus 77.8 , 100 , and 87.9 % for the training and the validation group .
RESULTS	In comparison , the area under the receiver operating curve for APRI = 0.810 , FIB4 = 0.781 , and Forns = 0.703 with a diagnostic accuracy of 83.9 , 72.3 , and 62 % and gray zone cases in 46.15 , 37.5 , and 44.2 % .
CONCLUSIONS	We devised an algorithm to calculate the NFS to predict SLF with good accuracy , fewer cases in the gray zone , and a straightforward clinical interpretation .
CONCLUSIONS	NFS could be used for the initial evaluation of the treatment priority .

###24721481
BACKGROUND	Nearly 80 % of substance dependent individuals also use tobacco , and smoking cessation efforts during treatment for other substance use is associated with similar or even improved outcomes .
BACKGROUND	However , smoking cessation is not routinely addressed during treatment for substance use disorders .
BACKGROUND	The present study tested a computerized brief motivational intervention ( C-BMI ) for smoking cessation in an understudied population : a cohort recruited from a recovery community organization ( RCO ) center .
METHODS	Following baseline assessment , participants were randomly assigned to either a 30-minute C-BMI plus access to free nicotine replacement therapy ( NRT ) , or an information-only control group plus NRT access .
RESULTS	Reductions in CO were observed for both groups .
RESULTS	Quit rates in the C-BMI group ( 5 % -7 % , vs. 0 % for the control group ) approximated those observed elsewhere for physician advice and minimal counseling .
RESULTS	Participants in the C-BMI group were also more likely to express a desire to quit .
CONCLUSIONS	Computer-delivered smoking cessation interventions within RCOs appear feasible .
CONCLUSIONS	These organizations treat a wide variety of individuals , and C-BMIs for smoking in this context have the potential to reduce smoking-related morbidity and mortality .

###25465809
BACKGROUND	Patients with Marfan ( MFS ) and Loeys-Dietz ( LDS ) syndromes have been shown to have abnormal aortic biophysical properties .
BACKGROUND	The purpose of this study was to compare the effects of 12-months of therapy with atenolol or losartan on vascular function in young patients with MFS and LDS .
METHODS	Seventeen patients with MFS or LDS were recruited and randomized to treatment with atenolol , 25-50mg , or losartan , 25mg daily .
METHODS	Prior to treatment and following therapy , echocardiography for left ventricular size , function and aortic root size was performed .
METHODS	Pulse wave velocity ( PWV ) , input ( Zi , ZiF ) and characteristic ( Zc , ZcF ) impedances , arterial stiffness ( Ep and - index ) , total arterial compliance ( TAC ) , mean ( Wm ) and total ( Wt ) hydraulic power , efficiency , power cost per unit of forward flow ( Wt/CI ) and brachial artery flow-mediated dilation ( FMD ) were measured .
RESULTS	The atenolol group consisted of 9 females ( 17.6 years ) and the losartan group 7 males and 1 female ( 17.0 years ) .
RESULTS	Their height , weight , BSA , BMI , systolic and diastolic blood pressures were similar .
RESULTS	Baseline to 12-month changes for atenolol and losartan were PWV ( 20 % vs -14 % ) , Zi ( -2 % vs -27 % ) , Zc ( -20 % vs -27 % ) , Ep ( 1 % , vs -13 % ) , - index ( 10 % vs 14 % ) , FMD ( 11 % vs 20 % ) , TAC ( 3 % vs 42 % ) , Wm ( -24 % vs 15 % ) , Wt ( -24 % vs 17 % ) , and Wt/CI ( 3 % vs 21 % ) .
RESULTS	There was a trend for losartan to decrease PWV and stiffness indexes while atenolol decreased power and power/unit flow .
CONCLUSIONS	This pilot study suggests that atenolol and losartan may have different mechanisms of action on vascular function .
CONCLUSIONS	A larger clinical trial is needed to confirm these effects.Clinical trials registration NCT00593710 ( ClinicalTrials.gov ) .

###25166440
BACKGROUND	Matrix metalloproteinases ( MMPs ) and cytokines play a role of extracellular matrix degradation and remodelling , and are significantly involved in the course of periodontal disease .
OBJECTIVE	The purpose of this study was to evaluate the adjunctive effect of administering an oxicam non-steroidal anti-inflammatory drug ( NSAID ) , tenoxicam , during non-surgical ( phase 1 ) periodontal treatment on clinical parameters and gingival crevicular fluid ( GCF ) levels of MMP-8 and TNF - in subjects with chronic periodontitis .
METHODS	A total of 32 subjects with chronic periodontitis were randomized into two groups : 1 ) phase I periodontal treatment + NSAID and 2 ) phase I periodontal treatment + placebo .
METHODS	Phase I periodontal therapy consisted of scaling and root planning ( SPR ) , which was provided by a single therapist masked with respect to group assignment .
METHODS	Patients in group 1 received a systemic NSAID ( 20 mg tenoxicam tablet once daily for 10 days ) .
METHODS	Clinical measures and GCF samples were obtained immediately prior to periodontal treatment and 30 days afterwards from all subjects .
METHODS	Clinical measures included a plaque index , gingival index , gingival bleeding time index , probing depth , and clinical attachment level .
METHODS	The MMP-8 and TNF - levels in the GCF were assayed using an enzyme-linked immunosorbent assay .
RESULTS	With the exception of clinical attachment level , all clinical measures showed a significant ( p < 0.05 ) improvement following non-surgical treatment in both the NSAID and placebo groups .
RESULTS	A significant decrease in MMP-8 levels ( p < 0.05 ) was observed at post-treatment in the NSAID group but not in the placebo group ( p > 0.05 ) .
RESULTS	Treatment exhibited no effect on TNF - levels ( p > 0.05 ) .
RESULTS	There was also no statistically significant difference in clinical measurements after treatment between the two groups ( p > 0.05 ) .
RESULTS	Moreover , the post treatment MMP-8 level in group 1 was statistically significant higher than the placebo group ( p < 0.05 ) .
CONCLUSIONS	The adjunctive administration of tenoxicam during phase I periodontal treatment decreases MMP-8 levels in gingival crevicular fluid in patients with chronic periodontitis .
CONCLUSIONS	But no benefits were observed .

###26101366
OBJECTIVE	Prophylactic vaccination of youngwomen aged 16 to 26 years with the 9-valent ( 6/11/16 / 18/31/33 / 45/52/58 ) human papillomavirus ( HPV ) virus-like particle ( 9vHPV ) vaccine prevents infection and disease .
OBJECTIVE	We conducted a noninferiority immunogenicity study to bridge the findings in young women to girls and boys aged 9 to 15 years .
METHODS	Subjects ( N = 3066 ) received a 3-dose regimen of 9vHPV vaccine administered at day 1 , month 2 , and month 6 .
METHODS	Anti-HPV serologic assays were performed at day 1 and month 7 .
METHODS	Noninferiority required that the lower bound of 2-sided 95 % confidence intervals of geometric mean titer ratios ( boys : young women or girls : young women ) be > 0.67 for each HPV type .
METHODS	Systemic and injection-site adverse experiences ( AEs ) and serious AEs were monitored .
RESULTS	At 4 weeks after dose 3 , > 99 % of girls , boys , and young women seroconverted for each vaccine HPV type .
RESULTS	Increases in geometric mean titers to HPV types 6/11/16 / 18/31/33 / 45/52/58 were elicited in all vaccine groups .
RESULTS	Responses in girls and boys were noninferior to those of young women .
RESULTS	Persistence of anti-HPV responses was demonstrated through 2.5 years after dose 3 .
RESULTS	Administration of the 9vHPV vaccine was generally well tolerated .
RESULTS	A lower proportion of girls ( 81.9 % ) and boys ( 72.8 % ) than young women ( 85.4 % ) reported injection-site AEs , most of which were mild to moderate in intensity .
CONCLUSIONS	These data support bridging the efficacy findings with 9vHPV vaccine in young women 16 to 26 years of age to girls and boys 9 to 15 years of age and implementing gender-neutral HPV vaccination programs in preadolescents and adolescents .

###25740691
OBJECTIVE	To evaluate safety of balugrastim , a recombinant human serum albumin and granulocyte colony-stimulating factor ( G-CSF ) , administered over a range of therapeutic doses in women with breast cancer receiving doxorubicin plus docetaxel chemotherapy .
METHODS	The phase I , sequential dose-escalation first segment compared subcutaneous balugrastim 50 , 150 , 300 , and 450g/kg during chemotherapy cycles 0-2 .
METHODS	The randomized ( 2:2:1 ) , open-label , phase IIa second segment compared balugrastim 300 or 450g/kg with pegfilgrastim 6mg during chemotherapy cycles 1 and 2 .
RESULTS	In the phase I segment , balugrastim was escalated to 450g/kg in 13 patients without dose-limiting toxicity .
RESULTS	Three ( 9.7 % ) of the 31 adverse events ( AEs ) reported in nine patients were grade 3 ( agranulocytosis , vomiting , hypertension ) ; none was grade 4 .
RESULTS	In the open-label phase IIa segment ( N = 51 ) , the majority of the 64 AEs reported in 31 ( 75.6 % ) balugrastim-treated patients were grade 1 ( 59.4 % ) , with 39.1 % grade 2 , 1.6 % grade 3 ( one AE of vomiting ) , and none grade 4 .
RESULTS	Of the 16 AEs reported in seven ( 70.0 % ) pegfilgrastim-treated patients , 87.5 % were grade 1 , 6.3 % were grade 2 , 6.3 % were grade 3 ( one AE of thrombocytopenia ) , and none were grade 4 .
RESULTS	Overall , there were six bone pain AEs reported , one in the balugrastim 300g/kg group and five in the balugrastim 450g/kg group .
RESULTS	No AEs in either study necessitated treatment interruption/discontinuation .
RESULTS	The incidence and duration of grade 3-4 neutropenia were similar between balugrastim - and pegfilgrastim-treated patients .
CONCLUSIONS	Balugrastim was well tolerated in this small population of breast cancer patients .

###25312265
OBJECTIVE	This study investigated the effects of aortic root infusion of sufentanil on myocardial ischemia/reperfusion injury in patients undergoing elective mitral valve replacement ( MVR ) with cardiopulmonary bypass ( CPB ) .
METHODS	A prospective , randomized , clinical study .
METHODS	A university-affiliated teaching hospital .
METHODS	Fifty-three adult patients undergoing elective MVR with CPB .
METHODS	Bolus infusions of sufentanil ( 0.2 g/kg , n = 24 ) or normal saline ( n = 29 ) were administered through the aortic root cardioplegia perfusion catheter 5 minutes before aortic unclamping .
RESULTS	Plasma concentrations of CK-MB and cTnI and variables including heart rate , mean arterial pressure , central venous pressure , cardiac output , stroke volume , duration of mechanical ventilation , length of ICU stay , length of hospital stay , and 24-hour postoperative inotropic scores were recorded .
RESULTS	Plasma concentrations of CK-MB and cTnI were significantly lower 4 and 8 hours after aortic unclamping in the sufentanil postconditioning group compared to control ( p < 0.05 ) .
RESULTS	Inotropic drug use , duration of mechanical ventilation , and length of ICU and hospital stays were reduced significantly in the sufentanil postconditioning group compared to control ( p < 0.05 ) .
CONCLUSIONS	The present study demonstrated that sufentanil can attenuate myocardial ischemia-reperfusion injury in patients undergoing elective MVR with CPB .

###25545744
BACKGROUND	Preclinical and epidemiologic studies suggest chemopreventive effects of green tea ( GT ) and black tea ( BT ) in prostate cancer .
BACKGROUND	In the current study we determined the effect of GT and BT consumption on biomarkers related to prostate cancer development and progression .
METHODS	In this exploratory , open label , phase II trial 113 men diagnosed with prostate cancer were randomized to consume six cups daily of brewed GT , BT or water ( control ) prior to radical prostatectomy ( RP ) .
METHODS	The primary endpoint was prostate tumor markers of cancer development and progression determined by tissue immunostaining of proliferation ( Ki67 ) , apoptosis ( Bcl-2 , Bax , Tunel ) , inflammation ( nuclear and cytoplasmic nuclear factor kappa B [ NFB ] ) and oxidation ( 8-hydroxydeoxy-guanosine [ 8OHdG ] ) .
METHODS	Secondary endpoints of urinary oxidation , tea polyphenol uptake in prostate tissue , and serum prostate specific antigen ( PSA ) were evaluated by high performance liquid chromatography and ELISA analysis .
RESULTS	Ninety three patients completed the intervention .
RESULTS	There was no significant difference in markers of proliferation , apoptosis and oxidation in RP tissue comparing GT and BT to water control .
RESULTS	Nuclear staining of NFB was significantly decreased in RP tissue of men consuming GT ( P = 0.013 ) but not BT ( P = 0.931 ) compared to water control .
RESULTS	Tea polyphenols were detected in prostate tissue from 32 of 34 men consuming GT but not in the other groups .
RESULTS	Evidence of a systemic antioxidant effect was observed ( reduced urinary 8OHdG ) only with GT consumption ( P = 0.03 ) .
RESULTS	GT , but not BT or water , also led to a small but statistically significant decrease in serum prostate-specific antigen ( PSA ) levels ( P = 0.04 ) .
CONCLUSIONS	Given the GT-induced changes in NFB and systemic oxidation , and uptake of GT polyphenols in prostate tissue , future longer-term studies are warranted to further examine the role of GT for prostate cancer prevention and treatment , and possibly for other prostate conditions such as prostatitis .

###25193416
BACKGROUND	The objective of the study was to compare the efficacy of external fixation and volar plating on the functional parameter of displaced intra-articular ( Cooney 's type IV ) distal end radius fractures using the Green and O'Brien scoring system .
METHODS	This prospective randomized study comprised 68 patients treated with external fixation and 42 patients treated with volar locking plates .
METHODS	The patients were followed up at 6 months and 1 year after surgery .
METHODS	The assessment of pain , range of motion , grip strength and activity were assessed at each follow-up visit and scored according to the Green and O'Brien scoring system .
RESULTS	At 1 year after surgery , we observed that external fixation showed significantly better results than volar locking plates using the Green and O'Brien scores for range of motion ( 22.0 4.77 vs 19.89 5.05 ) , grip strength ( 19.91 5.4 vs 16.89 4.4 ) and final outcome ( 87.36 11.62 vs 81.55 11.32 ) .
RESULTS	No difference was found in pain and activity between these two groups of patients .
RESULTS	Patients aged < 50 years treated with external fixation showed excellent results ( final score ( 91.57 9.01 ) at 1 year follow-up .
CONCLUSIONS	External fixation showed superiority over volar locked plating after 1 year of surgery .
METHODS	IV .

###24452090
OBJECTIVE	Aim of the present study was to compare the effectiveness of two renin-angiotensin-aldosterone system inhibitors in arterial stiffness reduction in previously untreated hypertensive patients .
METHODS	In this open label study , 154 nave , or not treated in the last six months hypertensive patients were randomly assigned to receive aliskiren 300 mg or ramipril 5 mg daily .
METHODS	Six weeks after the initiation of treatment , patients were evaluated for blood pressure ( BP ) control .
METHODS	Patients with SBP 140 and/or DBP 90 mmHg were assigned to an adjunct of 25 mg hydrochlorothiazide as combination treatment .
METHODS	A re-evaluation of BP control was done after another 6 weeks .
METHODS	Individuals with BP 140/90 mmHg were further administered amlodipine 5 mg .
METHODS	The final evaluation was performed six months after the start of the study .
METHODS	Twenty four-hour ambulatory blood pressure monitoring was carried out and the ambulatory arterial stiffness index ( AASI ) was calculated at baseline and after 6 months of treatment .
RESULTS	Aliskiren-based therapy , as compared with ramipril-based therapy reduced BP to a similar degree : 1311 vs. 1211 mmHg reduction in systolic ( P = 0.34 ) and 87 vs. 77 mmHg reduction in diastolic BP ( P = 0.44 ) .
RESULTS	AASI was reduced by 0.040.1 in the aliskiren group and by 0.020.2 in the ramipril group .
RESULTS	AASI reduction did not differ significantly in the two groups ( P = 0.13 ) .
CONCLUSIONS	In hypertensive patients , aliskiren-based treatment as well as ramipril-based treatment appears to have a beneficial effect on arterial stiffness .
CONCLUSIONS	As arterial stiffness is an important modifiable risk factor , our findings highlight the value of aliskiren beyond BP lowering properties .

###25734732
OBJECTIVE	Scattered-site housing with Intensive Case Management ( ICM ) may be an appropriate and less-costly option for homeless adults with mental illness who do not require the treatment intensity of Assertive Community Treatment .
OBJECTIVE	To examine the effect of scattered-site housing with ICM services on housing stability and generic quality of life among homeless adults with mental illness and moderate support needs for mental health services .
METHODS	The At Home/Chez Soi project was an unblinded , randomized trial .
METHODS	From October 2009 to July 2011 , participants ( N = 1198 ) were recruited in 4 Canadian cities ( Vancouver , Winnipeg , Toronto , and Montreal ) , randomized to the intervention group ( n = 689 ) or usual care group ( n = 509 ) , and followed up for 24 months .
METHODS	The intervention consisted of scattered-site housing ( using rent supplements ) and off-site ICM services .
METHODS	The usual care group had access to existing housing and support services in their communities .
METHODS	The primary outcome was the percentage of days stably housed during the 24-month period following randomization .
METHODS	The secondary outcome was generic quality of life , assessed by a EuroQoL 5 Dimensions ( EQ-5D ) health questionnaire .
RESULTS	During the 24 months after randomization , the adjusted percentage of days stably housed was higher among the intervention group than the usual care group , although adjusted mean differences varied across sites .
RESULTS	[ table : see text ] The mean change in EQ-5D score from baseline to 24 months among the intervention group was not statistically different from the usual care group ( 60.5 [ 95 % CI , 58.6 to 62.5 ] at baseline and 67.2 [ 95 % CI , 65.2 to 69.1 ] at 24 months for the intervention group vs 62.1 [ 95 % CI , 59.9 to 64.4 ] at baseline and 68.6 [ 95 % CI , 66.3 to 71.0 ] at 24 months for the usual care group , difference in mean changes , 0.10 [ 95 % CI , 2.92 to 3.13 ] , P = .95 ) .
CONCLUSIONS	Among homeless adults with mental illness in 4 Canadian cities , scattered site housing with ICM services compared with usual access to existing housing and community services resulted in increased housing stability over 24 months , but did not improve generic quality of life .
BACKGROUND	isrctn.org Identifier : ISRCTN42520374 .

###25151031
OBJECTIVE	Emerging evidence supports an association between metabolic risk factors and bone turnover .
OBJECTIVE	Statins and exercise independently improve metabolic risk factors ; however whether improvements in metabolic risk factor affects bone turnover is unknown .
OBJECTIVE	The purpose of the present study was to : 1 ) evaluate the relationship between metabolic risk factors and bone turnover ; and 2 ) determine if improvements in metabolic risk factors after 12 weeks of statin treatment , exercise or the combination affect bone turnover .
METHODS	Fifty participants with 2 metabolic syndrome defining characteristics were randomly assigned to one of three groups : statin ( STAT : simvastatin , 40 mg/day ) , exercise ( EX : brisk walking and/or slow jogging , 45 minutes/day , 5 days/week ) , or the combination ( STAT+EX ) .
METHODS	Body composition and whole body bone mineral density were measured with dual energy X-ray absorptiometry .
METHODS	Serum markers of bone formation ( bone specific alkaline phosphatase , BAP ; osteocalcin , OC ) , resorption ( C-terminal peptide of type I collagen , CTX ) and metabolic risk factors were determined .
METHODS	Two-factor ( time , group ) repeated-measures ANCOVA was used to examine changes of metabolic risk factors and bone turnover .
METHODS	General linear models were used to determine the effect of pre-treatment metabolic risk factors on post-treatment bone turnover marker outcomes .
RESULTS	Participants with 4 metabolic syndrome defining characteristics had lower pre-treatment OC than those with 3 or fewer .
RESULTS	OC was negatively correlated with glucose , and CTX was positively correlated with cholesterol .
RESULTS	STAT or STAT+EX lowered total and LDL cholesterol .
RESULTS	The OC to CTX ratio decreased in all groups with no other significant changes in bone turnover .
RESULTS	Higher pre-treatment insulin or body fat predicted a greater CTX reduction and a greater BAP/CTX increase .
CONCLUSIONS	Metabolic risk factors were negatively associated with bone turnover markers .
CONCLUSIONS	Short-term statin treatment with or without exercise lowered cholesterol and all treatments had a small effect on bone turnover .

###25468508
OBJECTIVE	There is insufficient evidence on which to base a recommendation for optimal antiplatelet therapy following a stroke while on aspirin .
OBJECTIVE	The objective was to compare clopidogrel initiation vs aspirin reinitiation for vascular risk reduction among patients with ischaemic stroke on aspirin at the time of their index stroke .
METHODS	Retrospective .
METHODS	We conducted a nationwide cohort study by retrieving all hospitalised patients ( 18 years ) with a primary diagnosis of ischaemic stroke between 2003 and 2009 from Taiwan National Health Insurance Research Database .
METHODS	Among 3862 patients receiving aspirin before the index ischaemic stroke and receiving either aspirin or clopidogrel after index stroke during follow-up period , 1623 were excluded due to a medication possession ratio < 80 % .
METHODS	Also , 355 were excluded due to history of atrial fibrillation , valvular heart disease or coagulopathy .
METHODS	Therefore , 1884 patients were included in our final analysis .
METHODS	Patients were categorised into two groups based on whether clopidogrel or aspirin was prescribed during the follow-up period .
METHODS	Follow-up was from time of the index stroke to admission for recurrent stroke or myocardial infarction , death or the end of 2010 .
METHODS	The primary end point was hospitalisation due to a new-onset major adverse cardiovascular event ( MACE : composite of any stroke or myocardial infarction ) .
METHODS	The leading secondary end point was any recurrent stroke .
RESULTS	Compared to aspirin , clopidogrel was associated with a lower occurrence of future MACE ( HR = 0.54 , 95 % CI 0.43 to 0.68 , p < 0.001 , number needed to treat : 8 ) and recurrent stroke ( HR = 0.54 , 95 % CI 0.42 to 0.69 , p < 0.001 , number needed to treat : 9 ) after adjustment of relevant covariates .
CONCLUSIONS	Among patients with an ischaemic stroke while taking aspirin , clopidogrel initiation was associated with fewer recurrent vascular events than aspirin reinitiation .

###24987842
BACKGROUND	Large common bile duct ( CBD ) stones remain a major challenge for endoscopists .
BACKGROUND	The capture of large CBD stones is a limiting factor for successful removal .
BACKGROUND	The aim of the study is to evaluate the efficacy and safety of stretching the basket out at the bottom of the stones to capture large CBD stones .
METHODS	Sixty-five patients with large stones ( > 20mm in diameter ) were selected and randomly divided into Group A ( 33 cases ) and Group B ( 34 cases ) .
METHODS	After appropriate sphincterotomy with balloon dilation , two different methods were used to capture stones .
METHODS	For Method A , the basket was inserted above a large stone and opened to capture it .
METHODS	For Method B , the basket was stretched out at the bottom of the large stone and opened slowly to capture it .
RESULTS	The success rate of capturing stones was 33.3 % in Group A and 94.1 % in Group B ( P < .05 ) .
RESULTS	There was no statistically significant difference in complication rate between the two groups ( P > .05 ) .
CONCLUSIONS	The success rate for capturing large CBD stones can be increased by stretching the basket out at the bottom of the stones to capture the stone .

###24634627
OBJECTIVE	To investigate the effects of botulinum toxin type A ( BoNT-A ) injection on jaw motor episodes during sleep in patients with or without orofacial pain who did not respond to oral splint treatment .
METHODS	Twenty subjects with a clinical diagnosis of SB completed this study .
METHODS	Ten subjects received bilateral BoNT-A injections ( 25 U per muscle ) into the masseter muscles only ( group A ) , and the other 10 received the injections into both the masseter and temporalis muscles ( group B ) .
METHODS	Video-polysomnographic ( vPSG ) recordings were made before and at 4 weeks after injection .
METHODS	Rhythmic masticatory muscle activity ( RMMA ) and orofacial activity ( OFA ) were scored and analyzed for several parameters ( e.g. , frequency of episodes , bursts per episode , episode duration ) .
METHODS	The peak amplitude of electromyographic ( EMG ) activity in the two muscles was also measured .
RESULTS	BoNT-A injection did not reduce the frequency , number of bursts , or duration for RMMA episodes in the two groups .
RESULTS	The injection decreased the peak amplitude of EMG burst of RMMA episodes in the injected muscles ( p < 0.001 , repeated measure ANOVA ) in both groups .
RESULTS	At 4 weeks after injection , 9 subjects self-reported reduction of tooth grinding and 18 subjects self-reported reduction of morning jaw stiffness .
CONCLUSIONS	A single BoNT-A injection is an effective strategy for controlling SB for at least a month .
CONCLUSIONS	It reduces the intensity rather than the generation of the contraction in jaw-closing muscles .
CONCLUSIONS	Future investigations on the efficacy and safety in larger samples over a longer follow-up period are needed before establishing management strategies for SB with BoNT-A .
BACKGROUND	Shim YJ ; Lee MK ; Kato T ; Park HU ; Heo K ; Kim ST. Effects of botulinum toxin on jaw motor events during sleep in sleep bruxism patients : a polysomnographic evaluation .

###25728808
BACKGROUND	Faecal microbiota transplantation ( FMT ) from healthy donors is considered an effective treatment against recurrent Clostridium difficile infection .
OBJECTIVE	To study the effect of FMT via colonoscopy in patients with recurrent C. difficile infection compared to the standard vancomycin regimen .
METHODS	In an open-label , randomised clinical trial , we assigned subjects with recurrent C. difficile infection to receive : FMT , short regimen of vancomycin ( 125mg four times a day for 3days ) , followed by one or more infusions of faeces via colonoscopy ; or vancomycin , vancomycin 125mg four times daily for 10days , followed by 125-500mg / day every 2-3days for at least 3weeks .
METHODS	The latter treatment did not include performing colonoscopy .
METHODS	The primary end point was the resolution of diarrhoea related to C. difficile infection 10weeks after the end of treatments .
RESULTS	The study was stopped after a 1-year interim analysis .
RESULTS	Eighteen of the 20 patients ( 90 % ) treated by FMT exhibited resolution of C. difficile-associated diarrhoea .
RESULTS	In FMT , five of the seven patients with pseudomembranous colitis reported a resolution of diarrhoea .
RESULTS	Resolution of C. difficile infection occurred in 5 of the 19 ( 26 % ) patients in vancomycin ( P < 0.0001 ) .
RESULTS	No significant adverse events were observed in either of the study groups .
CONCLUSIONS	Faecal microbiota transplantation using colonoscopy to infuse faeces was significantly more effective than vancomycin regimen for the treatment of recurrent C. difficile infection .
CONCLUSIONS	The delivery of donor faeces via colonoscopy has the potential to optimise the treatment strategy in patients with pseudomembranous colitis .

###24751780
BACKGROUND	In many low income countries , the delivery of quality health services is hampered by health system-wide barriers which are often interlinked , however empirical evidence on how to assess the level and scope of these barriers is scarce .
BACKGROUND	A balanced scorecard is a tool that allows for wider analysis of domains that are deemed important in achieving the overall vision of the health system .
BACKGROUND	We present the quantitative results of the 12 months follow-up study applying the balanced scorecard approach in the BHOMA intervention with the aim of demonstrating the utility of the balanced scorecard in evaluating multiple building blocks in a trial setting .
METHODS	The BHOMA is a cluster randomised trial that aims to strengthen the health system in three rural districts in Zambia .
METHODS	The intervention aims to improve clinical care quality by implementing practical tools that establish clear clinical care standards through intensive clinic implementations .
METHODS	This paper reports the findings of the follow-up health facility survey that was conducted after 12 months of intervention implementation .
METHODS	Comparisons were made between those facilities in the intervention and control sites .
METHODS	STATA version 12 was used for analysis .
RESULTS	The study found significant mean differences between intervention ( I ) and control ( C ) sites in the following domains : Training domain ( Mean I : C ; 87.5 .
RESULTS	vs 61.1 , mean difference 23.3 , p = 0.031 ) , adult clinical observation domain ( mean I : C ; 73.3 vs. 58.0 , mean difference 10.9 , p = 0.02 ) and health information domain ( mean I : C ; 63.6 vs. 56.1 , mean difference 6.8 , p = 0.01 .
RESULTS	There was no gender differences in adult service satisfaction .
RESULTS	Governance and motivation scores did not differ between control and intervention sites .
CONCLUSIONS	This study demonstrates the utility of the balanced scorecard in assessing multiple elements of the health system .
CONCLUSIONS	Using system wide approaches and triangulating data collection methods seems to be key to successful evaluation of such complex health intervention .
BACKGROUND	ClinicalTrials.gov NCT01942278 .

###24758079
OBJECTIVE	To investigate the effect of Busheng Huoxue Capsule ( BHC ) on the quality of life ( QOL ) in senile male osteoporosis ( OP ) patients , and to explore its mechanisms .
METHODS	Totally 200 senile primary OP patients were randomly assigned to two groups according to random digit table method , 100 in each group .
METHODS	Patients in the treatment group took BHC plus caltrate-D ( 600 mg CaCO3 ) , while those in the control group took alendronate ( 70 mg per week ) plus caltrate-D .
METHODS	The therapeutic course was 12 months for all .
METHODS	Chinese medical symptom score and quality of life ( QUALEFFO-41 ) score , bone mineral density ( BMD ) of lumbar vertebra ( L2 - L4 ) and left femoral neck were compared between the two groups before and after treatment .
METHODS	Serum free testosterone ( FT ) and estradiol ( E2 ) were also measured .
RESULTS	Chinese medical symptom scores and QUALEFFO-41 scores , serum FT and E2 levels increased in the two groups after treatment ( P < 0.05 , P < 0.01 ) .
RESULTS	The therapeutic effect was superior in the treatment group ( P < 0.05 , P < 0.01 ) .
RESULTS	After treatment the BMD of lumbar vertebra ( L2 - L4 ) and the left femoral neck were somewhat improved ( P < 0.05 ) , but with no statistical difference between the two groups ( P > 0.05 ) .
CONCLUSIONS	BHC could effectively improve the QOL of senile male OP patients , which might be correlated with elevating the BMD levels and regulating the levels of sex hormones .

###25027424
OBJECTIVE	To evaluate the clinical value of tube-sealing with norvancomycin and heparin saline mixture for prevention of central venous catheter-related infection ( CRI ) .
METHODS	A prospective randomized controlled trial was performed .
METHODS	120 patients who were admitted to department of critical care medicine from January 2012 to January 2014 were included , with their subclavian vein catheterization installation time longer than 48 hours , age over 18 years and younger than 80 years , and acute physiology and chronic health evaluation II ( APACHE II ) score reaching 10-29 .
METHODS	The patients were divided into two groups using a random number table , and finally 116 patients were enrolled .
METHODS	Norvancomycin and heparin saline mixture were used for tube sealing in the intervention group ( n = 56 ) , while only heparin saline was used in the control group ( n = 60 ) .
METHODS	The incidence of CRI , catheter correlated spectrum of pathogens , adverse events , mortality , hospital day , catheter retention time , and hospital costs were compared between two groups .
RESULTS	( 1 ) There was no significant difference in the incidence of CRI between intervention group and control group [ 7.14 % ( 4/56 ) vs. 8.33 % ( 5/60 ) , ( 2 ) = 0.058 , P = 1.000 ] .
RESULTS	There was no catheter pathogenic colonization in the intervention group , but there were 2 cases of catheter pathogenic colonization in control group .
RESULTS	( 2 ) A total of 7 pathogens were found in two groups .
RESULTS	Three cases with pathogenic bacteria was found in the intervention group , with 1 case of Pseudomonas aeruginosa , 1 case Acinetobacter baumannii , and 1 case fungi .
RESULTS	Staphylococcus aureus , Staphylococcus epidermidis , fungi , and Acinetobacter baumannii was found in the control group , with 1 case of each .
RESULTS	There was no significantly statistical difference between two groups ( all P > 0.05 ) , but there was a decreasing trend of Gram-positive cocci infection in the intervention group .
RESULTS	( 3 ) There was no significant difference in the catheter thrombosis , local bleeding or hematoma , catheter dislocation and other adverse events between intervention group and control group [ 21.43 % ( 12/56 ) vs. 23.33 % ( 14/60 ) , ( 2 ) = 0.060 , P = 0.806 ] .
RESULTS	( 4 ) There were no significant differences in mortality [ 7.14 % ( 4/56 ) vs. 8.33 % ( 5/60 ) , ( 2 ) = 0.058 , P = 1.000 ] , hospital day ( 35.915.2 days vs. 34.116.3 days , t = 16.330 , P = 0.620 ) , catheter retention time ( 25.04.5 days vs. 24.55.1 days , t = 26.427 , P = 2.560 ) and cost of hospitalization ( 10 thousand Yuan : 3.421.22 vs. 3.721.30 , t = 13.215 , P = 1.560 ) between intervention group and control group .
CONCLUSIONS	For patients with central venous catheter , application norvancomycin with heparin saline mixture for tube sealing did not reduce the incidence of CRI , the incidence of adverse events and mortality , does not reduce hospitalization time , catheter retention time and hospital costs , but may reduce the catheter colonization and infection of Gram-positive bacteria .

###24393852
BACKGROUND	Effective therapies after failure of treatment with anthracyclines and taxanes are needed for patients with metastatic breast cancer .
BACKGROUND	Dinaciclib ( MK-7965 , formerly SCH727965 ) , a small-molecule cyclin-dependent kinase inhibitor , has demonstrated antitumor activity in phase I studies with solid-tumor patients .
BACKGROUND	This phase II trial was designed to assess the efficacy and safety of dinaciclib compared with that of capecitabine in women with previously treated advanced breast cancer .
METHODS	Patients were randomized to receive either dinaciclib at 50mg/m ( 2 ) , administered as a 2-hour infusion every 21 days , or 1250 mg/m ( 2 ) capecitabine , administered orally twice daily in 21-day cycles .
RESULTS	An unplanned interim analysis showed that the time to disease progression was inferior with dinaciclib treatment compared with capecitabine treatment ; therefore , the trial was stopped after 30 patients were randomized .
RESULTS	Dinaciclib treatment demonstrated antitumor activity in 2 of 7 patients with estrogen receptor-positive and human epidermal growth factor receptor 2-negative metastatic breast cancer ( 1 confirmed and 1 unconfirmed partial response ) , as well as acceptable safety and tolerability .
RESULTS	Grade 3 or 4 treatment-related adverse events were common and included neutropenia , leukopenia , increase in aspartate aminotransferase , and febrile neutropenia .
RESULTS	Population pharmacokinetic model-predicted mean dinaciclib exposure ( area under the concentration-time curve extrapolated to infinity [ AUC [ I ] ] ) at 50 mg/m ( 2 ) was similar to that observed in a previous phase I trial , and no drug accumulation was observed after multiple-dose administration .
CONCLUSIONS	Although dinaciclib monotherapy demonstrated some antitumor activity and was generally tolerated , efficacy was not superior to capecitabine .
CONCLUSIONS	Future studies may be considered to evaluate dinaciclib in select patient populations with metastatic breast cancer and in combination with other agents .

###24260195
BACKGROUND	The FMP2 .1 / AS02A candidate malaria vaccine was tested in a Phase 2 study in Mali .
BACKGROUND	Based on results from the first eight months of follow-up , the vaccine appeared well-tolerated and immunogenic .
BACKGROUND	It had no significant efficacy based on the primary endpoint , clinical malaria , but marginal efficacy against clinical malaria in secondary analyses , and high allele-specific efficacy .
BACKGROUND	Extended follow-up was conducted to evaluate extended safety , immunogenicity and efficacy .
METHODS	A randomized , double-blinded trial of safety , immunogenicity and efficacy of the candidate Plasmodium falciparum apical membrane antigen 1 ( AMA1 ) vaccine FMP2 .1 / AS02A was conducted in Bandiagara , Mali .
METHODS	Children aged 1-6 years were randomized in a 11 ratio to receive FMP2 .1 / AS02A or control rabies vaccine on days 0 , 30 and 60 .
METHODS	Using active and passive surveillance , clinical malaria and adverse events as well as antibodies against P. falciparum AMA1 were monitored for 24 months after the first vaccination , spanning two malaria seasons .
RESULTS	400 children were enrolled .
RESULTS	Serious adverse events occurred in nine participants in the FMP2 .1 / AS02A group and three in the control group ; none was considered related to study vaccination .
RESULTS	After two years , anti-AMA1 immune responses remained significantly higher in the FMP2 .1 / AS02A group than in the control group .
RESULTS	For the entire 24-month follow-up period , vaccine efficacy was 7.6 % ( p = 0.51 ) against first clinical malaria episodes and 9.9 % ( p = 0.19 ) against all malaria episodes .
RESULTS	For the final 16-month follow-up period , vaccine efficacy was 0.9 % ( p = 0.98 ) against all malaria episodes .
RESULTS	Allele-specific efficacy seen in the first malaria season did not extend into the second season of follow-up .
CONCLUSIONS	Allele-specific vaccine efficacy was not sustained in the second malaria season , despite continued high levels of anti-AMA1 antibodies .
CONCLUSIONS	This study presents an opportunity to evaluate correlates of partial protection against clinical malaria that waned during the second malaria season .
BACKGROUND	Clinicaltrials.gov NCT00460525 NCT00460525 .

###24474233
BACKGROUND	Unspecified Ulcerative Rectocolitis is a chronic disease that affects between 0.5 and 24.5 / 105 inhabitants in the world .
BACKGROUND	National and international clinical guidelines recommend the use of aminosalicylates ( including mesalazine ) as first-line therapy for induction of remission of unspecified ulcerative rectocolitis , and recommend the maintenance of these agents after remission is achieved .
BACKGROUND	However , multiple daily doses required for the maintenance of disease remission compromise compliance with treatment , which is very low ( between 45 % and 65 % ) .
BACKGROUND	Use of mesalazina in granules ( 2 g sachet ) once daily -- Pentasa sachets 2 g -- can enhance treatment adherence , reflecting in an improvement in patients ' outcomes .
OBJECTIVE	To evaluate the evidence on the use of mesalazine for the maintenance of remission in patients with unspecified ulcerative rectocolitis and its effectiveness when taken once versus more than once a day .
OBJECTIVE	From an economic standpoint , to analyze the impact of the adoption of this dosage in Brazil 's public health system , considering patients ' adherence to treatment .
METHODS	A decision tree was developed based on the Clinical Protocol and Therapeutic Guidelines for Ulcerative Colitis , published by the Ministry of Health in the lobby SAS/MS n 861 of November 4 th , 2002 and on the algorithms published by the Associao Brasileira de Colite Ulcerativa e Doena de Crohn , aiming to get the cost-effectiveness of mesalazine once daily in granules compared with mesalazine twice daily in tablets .
RESULTS	The use of mesalazine increases the chances of remission induction and maintenance when compared to placebo , and higher doses are associated with greater chance of success without increasing the risk of adverse events .
CONCLUSIONS	The use of a single daily dose in the maintenance of remission is effective and related to higher patient compliance when compared to the multiple daily dose regimens , with lower costs .

###24578607
METHODS	A randomized , double-blind , active-controlled trial .
OBJECTIVE	To assess the effectiveness of cervical interlaminar epidural injections of local anesthetic with or without steroids for the management of axial or discogenic pain in patients without disc herniation , radiculitis , or facet joint pain .
BACKGROUND	Cervical discogenic pain without disc herniation is a common cause of suffering and disability in the adult population .
BACKGROUND	Once conservative management has failed and facet joint pain has been excluded , cervical epidural injections may be considered as a management tool .
BACKGROUND	Despite a paucity of evidence , cervical epidural injections are one of the most commonly performed nonsurgical interventions in the management of chronic axial or disc-related neck pain .
METHODS	One hundred and twenty patients without disc herniation or radiculitis and negative for facet joint pain as determined by means of controlled diagnostic medial branch blocks were randomly assigned to one of the 2 treatment groups .
METHODS	Group I patients received cervical interlaminar epidural injections of local anesthetic ( lidocaine 0.5 % , 5 mL ) , whereas Group II patients received 0.5 % lidocaine , 4 mL , mixed with 1 mL or 6 mg of nonparticulate betamethasone .
METHODS	The primary outcome measure was 50 % improvement in pain and function .
METHODS	Outcome assessments included numeric rating scale ( NRS ) , Neck Disability Index ( NDI ) , opioid intake , employment , and changes in weight .
RESULTS	Significant pain relief and functional improvement ( 50 % ) was present at the end of 2 years in 73 % of patients receiving local anesthetic only and 70 % receiving local anesthetic with steroids .
RESULTS	In the successful group of patients , however , defined as consistent relief with 2 initial injections of at least 3 weeks , significant improvement was illustrated in 78 % in the local anesthetic group and 75 % in the local anesthetic with steroid group at the end of 2 years .
RESULTS	The results reported at the one-year follow-up were sustained at the 2-year follow-up .
CONCLUSIONS	Cervical interlaminar epidural injections with or without steroids may provide significant improvement in pain and functioning in patients with chronic discogenic or axial pain that is function-limiting and not related to facet joint pain .

###25314652
OBJECTIVE	We determined whether U-shaped relationships exist between serum lipoprotein [ Lp ] ( a ) and cardiometabolic risk .
METHODS	In population-based nondiabetic and diabetic middle-aged adults ( n = 1428 and 241 , respectively ) who had been genotyped for the LPA rs10455872 A > G polymorphism , we adjusted the Lp ( a ) concentration for the effects of genotype and other covariates .
METHODS	Via sex-specific equations we estimated expected Lp ( a ) concentration in each participant , and the quotient between observed to expected Lp ( a ) values was determined .
METHODS	Lp ( a ) and Lp ( a ) quotient tertiles served to identify non-linear associations with outcomes .
RESULTS	Incident 81 cases of diabetes and 128 of coronary heart disease ( CHD ) developed at 5.1 years ' follow-up .
RESULTS	Lp ( a ) concentration was linearly associated with the LPA genotype , gender , total cholesterol , ( inversely ) fasting insulin , which together with age formed the variables to derive the equations .
RESULTS	In logistic regression for incident diabetes , the low Lp ( a ) quotient tertile was a predictor ( RR 1.95 [ 95 % CI 1.10 ; 3.47 ] ) alike the low Lp ( a ) tertile , additively to major confounders .
RESULTS	Cox regression models comprising sex , age , LPA genotype , smoking status , systolic pressure and serum HDL-cholesterol disclosed that , compared with the mid-tertile , both low ( HR 1.77 ) and high Lp ( a ) quotient tertiles significantly predicted incident CHD , especially in women .
CONCLUSIONS	Elevated cardiometabolic risk is conferred by apparently reduced circulating Lp ( a ) assays supporting the notion that `` low '' serum Lp ( a ) , mediating autoimmune activation , is a major determinant of cardiometabolic risk .

###24916176
BACKGROUND	Despite efforts to identify effective interventions to implement evidence-based practice ( EBP ) , uncertainty remains .
BACKGROUND	Few existing studies involve occupational therapists or resource-constrained contexts .
BACKGROUND	This study aimed to determine whether an interactive educational intervention ( IE ) was more effective than a didactic educational intervention ( DE ) in improving EBP knowledge , attitudes and behaviour at 12 weeks .
METHODS	A matched pairs design , randomised controlled trial was conducted in the Western Cape of South Africa .
METHODS	Occupational therapists employed by the Department of Health were randomised using matched-pair stratification by type ( clinician or manager ) and knowledge score .
METHODS	Allocation to an IE or a DE was by coin-tossing .
METHODS	A self-report questionnaire ( measuring objective knowledge and subjective attitudes ) and audit checklist ( measuring objective behaviour ) were completed at baseline and 12 weeks .
METHODS	The primary outcome was EBP knowledge at 12 weeks while secondary outcomes were attitudes and behaviour at 12 weeks .
METHODS	Data collection occurred at participants ' places of employment .
METHODS	Audit raters were blinded , but participants and the provider could not be blinded .
RESULTS	Twenty-one of 28 pairs reported outcomes , but due to incomplete data for two participants , 19 pairs were included in the analysis .
RESULTS	There was a median increase of 1.0 points ( 95 % CI = -4.0 , 1.0 ) in the IE for the primary outcome ( knowledge ) compared with the DE , but this difference was not significant ( P = 0.098 ) .
RESULTS	There were no significant differences on any of the attitude subscale scores .
RESULTS	The median 12-week audit score was 8.6 points higher in the IE ( 95 % CI = -7.7 , 27.0 ) but this was not significant ( P = 0.196 ) .
RESULTS	Within-group analyses showed significant increases in knowledge in both groups ( IE : T = 4.0 , P < 0.001 ; DE : T = 12.0 , P = 0.002 ) but no significant differences in attitudes or behaviour .
CONCLUSIONS	The results suggest that the interventions had similar outcomes at 12 weeks and that the interactive component had little additional effect .
BACKGROUND	Pan African Controlled Trials Register PACTR201201000346141 , registered 31 January 2012 .
BACKGROUND	Clinical Trials NCT01512823 , registered 1 February 2012 .
BACKGROUND	South African National Clinical Trial Register DOH2710093067 , registered 27 October 2009 .
BACKGROUND	The first participants were randomly assigned on 16 July 2008 .

###25348157
BACKGROUND	Neurological complications after cardiac surgery have a profound impact on postoperative survival and quality of life .
BACKGROUND	The increasing importance of strategies designed to improve neurological outcomes mirrors the growing risk burden of the contemporary cardiac surgical population .
BACKGROUND	Remote ischemic preconditioning ( RIPC ) reduces adverse sequelae of ischemia in vulnerable organs by subjecting tissues with high ischemic tolerance to brief periods of hypoperfusion .
BACKGROUND	This trial will evaluate the neuroprotective effect of RIPC in the cardiac surgical arena , by employing magnetic resonance imaging ( MRI ) and neurocognitive testing .
METHODS	Patients scheduled for elective coronary artery bypass grafting with the use of cardiopulmonary bypass will be screened for the study .
METHODS	Eligible patients will be randomized to undergo either a validated RIPC protocol or a sham procedure .
METHODS	The RIPC will be induced by inflation of a blood pressure cuff to 200 mmHg for 5 minutes , followed by a 5-minute reperfusion period .
METHODS	Three sequences of interchanging cuff inflations and deflations will be employed .
METHODS	Neurocognitive testing and MRI imaging will be performed preoperatively and on postoperative day 7 .
METHODS	Paired pre - and postoperative neurocognitive and neuroimaging data will then be compared .
METHODS	The primary composite outcome measure will consist of new ischemic lesions on brain MRI , postprocedural impairment in brain connectivity on resting-state functional MRI ( rs-fMRI ) , and significant new declines in neurocognitive performance .
METHODS	The secondary endpoint measures will be the individual components of the primary endpoint measures , expressed as continuous variables , troponin T release on postoperative day 1 and the incidence of major adverse cardiovascular events at 3 months postoperatively .
METHODS	Major adverse cardiovascular events , including accumulating cardiovascular mortality , stroke , nonfatal myocardial infarction , and rehospitalization for ischemia , will form a composite endpoint measure .
CONCLUSIONS	This trial will aim to assess whether RIPC in patients subjected to surgical myocardial revascularization employing cardiopulmonary bypass initiates a neuroprotective response .
CONCLUSIONS	Should the results of this trial indicate that RIPC is effective in reducing the incidence of adverse neurological events in patients undergoing coronary artery bypass grafting , it could impact on the current standard of care .
BACKGROUND	ClinicalTrials.gov NCT02177981 .

###24282383
OBJECTIVE	To evaluate the sustaining effects of Tai Chi Qigong ( TCQ ) in improving the psychosocial health in chronic obstructive pulmonary disease ( COPD ) patients in the sixth month .
BACKGROUND	COPD affects both physical and emotional aspects of life .
BACKGROUND	Measures to minimize patients ' suffering need to be implemented .
METHODS	206 COPD patients were randomly assigned into three groups : TCQ group , exercise group , and control group .
METHODS	The TCQ group completed a three-month TCQ program , the exercise group practiced breathing and walking exercise , and the control group received usual care .
RESULTS	Significant group-by-time interactions in quality of life ( QOL ) using St. George 's respiratory questionnaire ( P = 0.002 ) and the perceived social support from friends using multidimensional scale of perceived social support ( P = 0.04 ) were noted .
RESULTS	Improvements were observed in the TCQ group only .
CONCLUSIONS	TCQ has sustaining effects in improving psychosocial health ; it is also a useful and appropriate exercise for COPD patients .

###24687684
OBJECTIVE	Recent data suggest that chronic low-grade inflammation , a characteristic of obesity , is associated with altered tryptophan ( Trp ) and tyrosine ( Tyr ) metabolism and plays a role in neuropsychiatric symptoms .
OBJECTIVE	The present study assessed the effect of an extreme short-term diet on Trp breakdown and inflammatory biomarkers in overweight adults .
METHODS	Thirty-eight overweight participants ( 16 women , 22 men ; average body mass index : 29 kg/m , mean age 52.8 years ) were randomized into two diet groups : a very low kcal diet group ( VLCD ; 600 kcal/day , n = 21 ) and a low kcal diet group ( LCD ; 1,200 kcal/day , n = 17 ) .
METHODS	Assays included the measurement of Trp , kynurenine ( Kyn ) , and their ratio , neopterin , phenylalanine ( Phe ) , Tyr , as biologic markers ; leptin , plasma insulin , glucose , and homeostatic model assessment-insulin resistance ; and interleukin 6 , tumor necrosis factor alpha , and C-reactive protein , as biochemical and inflammatory markers at baseline and after 2 weeks of treatment .
RESULTS	Weight loss diet lowered leptin levels in both groups by 46 % , although not reaching significance .
RESULTS	Trp and Kyn decreased significantly by 21 and 16 % for VLCD and by 15 and 17 % for the LCD group , respectively .
RESULTS	A significant reduction in Phe was only seen after VLCD .
RESULTS	Inflammatory biomarkers , neopterin , and Tyr were not significantly altered during the study period .
RESULTS	Leptin was significantly correlated with Trp breakdown before and after the intervention ( P < 0.02 ) .
CONCLUSIONS	Since disturbed metabolism of Trp affects biosynthesis of serotonin and might be associated with increased susceptibility for mood disturbances and carbohydrate craving , strategies to supplement Trp while dieting could be highly useful in treating uncontrolled weight gain or in preventing neuropsychiatric symptoms .

###25091614
OBJECTIVE	To determine in patients with normal ejection fraction , undergoing permanent VVI pacing , if medial septal stimulation has lower dyssynchrony than apical stimulation assessed by echocardiography .
METHODS	A prospective trial , 19 patients > 70 years old , scheduled for VVI pacemaker implantation for complete degenerative atrioventricular block , ventricular frequency < 50beat per minute and ejection fraction45 % .
METHODS	Patients with atrial fibrillation , heart failure , left bundle branch block and QRS durations longer than 120milliseconds in surface electrocardiogram with sinus rhythm were excluded .
METHODS	Patients were randomized to apical implantation group A : 47 % and septal implantation group B : 53 % .
METHODS	Echocardiographic parameters were measured previous to the implant , 48h , 5 and 48 months after implantation .
RESULTS	No patients had diagnosis of ischemic cardiomyopathy or heart failure .
RESULTS	Echocardiographic parameters for interventricular dyssynchrony between groups were A : 14.4419.76 msec vs. B : 936.45 msec ; A : 6.1162.11 msec vs. B : 1338.31 msec ; A : 7753.51 msec vs. B : 24.2980.90 msec , P = NS ) .
RESULTS	For interventricular dyssynchrony were A : 46.4419.76 msec vs. B : 42.2029.56 msec ; A : 45.3345.67 msec vs. B : 29.8044.66 msec ; A : 46,3820 msec vs. B : 2127.20 msec , P = NS ) at 48h , 5 and 48 months , respectively .
CONCLUSIONS	Apical site of stimulation does not increase ventricular dyssynchrony rate in patients with preserved ejection fraction .
CONCLUSIONS	Septal stimulation showed decreased trend in interventricular dyssynchrony .

###24567288
BACKGROUND	Cancer is the leading cause of death among Asian Americans .
BACKGROUND	While Asian Americans are the fastest growing minority population in the United States , they are underrepresented in cancer research and report poor adherence to cancer screening guidelines .
OBJECTIVE	This study utilized data from two large randomized intervention trials to evaluate strategies to recruit first-generation Chinese American immigrants from community settings and Chinese American physician practices .
OBJECTIVE	Findings will inform effective strategies for promoting Asian American participation in cancer control research .
METHODS	Chinese Americans who were non-adherent to annual mammography screening guidelines ( Study 1 with 664 immigrant women > 40 years of age ) and to colorectal cancer screening guidelines ( Study 2 with 455 immigrants > 50 years of age ) were enrolled from the greater Washington DC , New York City ( NYC ) , and Philadelphia ( PA ) areas .
METHODS	Both studies trained bilingual staff to enroll Chinese-speaking participants with the aid of linguistically appropriate fliers and brochures to obtain consent .
METHODS	Study 1 adopted community approaches and worked with community organizations to enroll participants .
METHODS	Study 2 randomly selected potential participants through 24 Chinese American primary-care physician offices , and mailed letters from physicians to enroll patients , followed by telephone calls from research staff .
METHODS	The success of recruitment approaches was assessed by yield rates based on number of participants approached , ineligible , and consented .
RESULTS	Most participants ( 70 % ) of Study 1 were enrolled through in-person community approaches ( e.g. , Chinese schools , stores , health fairs , and personal networks ) .
RESULTS	The final yield of specific venues differed widely ( 6 % to 100 % ) due to various proportions of ineligible subjects ( 2 % -64 % ) and refusals ( 0 % -92 % ) .
RESULTS	The Study 2 recruitment approach ( physician letter followed by telephone calls ) had different outcomes in two geographic areas , partially due to differences in demographic characteristics in the DC and NYC/PA areas .
RESULTS	The community approaches enrolled more recent immigrants and uninsured Chinese Americans than the physician and telephone call approach ( p < .001 ) .
RESULTS	Enrollment cost is provided to inform future research studies .
CONCLUSIONS	Our recruitment outcomes might not be generalizable to all Chinese Americans or other Asian American populations because they may vary by study protocols ( e.g. , length of trials ) , target populations ( i.e. , eligibility criteria ) , and available resources .
CONCLUSIONS	Use of multiple culturally relevant strategies ( e.g. , building trusting relationships through face-to-face enrollment , use of bilingual and bicultural staff , use of a physician letter , and employing linguistically appropriate materials ) was crucial for successfully recruiting a large number of Chinese Americans in community and clinical settings .
CONCLUSIONS	Our data demonstrate that substantial effort is required for recruitment ; studies need to budget for this effort to ensure the inclusion of Asian Americans in health research .

###24759852
OBJECTIVE	Cognitive behavior therapy ( CBT ) has been established as efficacious for obsessive-compulsive disorder ( OCD ) among older children and adolescents , yet its effect on young children has not been evaluated sufficiently .
OBJECTIVE	To examine the relative efficacy of family-based CBT ( FB-CBT ) involving exposure plus response prevention vs an FB relaxation treatment ( FB-RT ) control condition for children 5 to 8 years of age .
METHODS	A 14-week randomized clinical trial ( Pediatric Obsessive-Compulsive Disorder Treatment Study for Young Children [ POTS Jr ] ) conducted at 3 academic medical centers between 2006 and 2011 , involving 127 pediatric outpatients 5 to 8 years of age who received a primary diagnosis of OCD and a Children 's Yale-Brown Obsessive Compulsive Scale total score of 16 or higher .
METHODS	Participants were randomly assigned to 14 weeks of ( 1 ) FB-CBT , including exposure plus response prevention , or ( 2 ) FB-RT .
METHODS	Responder status defined as an independent evaluator-rated Clinical Global Impression-Improvement scale score of 1 ( very much improved ) or 2 ( much improved ) and change in independent evaluator-rated continuous Children 's Yale-Brown Obsessive Compulsive Scale total score .
METHODS	RESULTS Family-based CBT was superior to FB-RT on both primary outcome measures .
METHODS	The percentages of children who were rated as 1 ( very much improved ) or 2 ( much improved ) on the Clinical Global Impression-Improvement scale at 14 weeks were 72 % for FB-CBT and 41 % for FB-RT .
METHODS	The effect size difference between FB-CBT and FB-RT on the Clinical Global Impression-Improvement scale was 0.31 ( 95 % CI , 0.17-0 .45 ) .
METHODS	The number needed to treat ( NNT ) with FB-CBT vs FB-RT was estimated as 3.2 ( 95 % CI , 2.2-5 .8 ) .
METHODS	The effect size difference between FB-CBT and FB-RT on the Children 's Yale-Brown Obsessive Compulsive Scale at week 14 was 0.84 ( 95 % CI , 0.62-1 .06 ) .
CONCLUSIONS	A comprehensive FB-CBT program was superior to a relaxation program with a similar format in reducing OCD symptoms and functional impairment in young children ( 5-8 years of age ) with OCD .
BACKGROUND	clinicaltrials.gov Identifier : NCT00533806 .

###26197184
OBJECTIVE	Human infections with the avian influenza A ( H7N9 ) virus were first reported in China in 2013 and continue to occur .
OBJECTIVE	Hemagglutinin H7 administered alone is a poor immunogen necessitating evaluation of adjuvanted H7N9 vaccines .
OBJECTIVE	To evaluate the immunogenicity and safety of an inactivated H7N9 vaccine with and without AS03 adjuvant , as well as mixed vaccine schedules that included sequential administration of AS03 - and MF59-containing formulations and of adjuvanted and unadjuvanted formulations .
METHODS	Double-blind , phase 2 trial at 5 US sites enrolled 980 adults aged 19 through 64 years from September 2013 through November 2013 ; safety follow-up was completed in January 2015 .
METHODS	The H7N9 vaccine was given on days 0 and 21 at nominal doses of 3.75 g , 7.5 g , 15 g , and 45 g of hemagglutinin with or without AS03 or MF59 adjuvant mixed on site .
METHODS	Proportions achieving a hemagglutination inhibition antibody ( HIA ) titer of 40 or higher at 21 days after the second vaccination ; vaccine-related serious adverse events through 12 months after the first vaccination ; and solicited signs and symptoms after vaccination through day 7 .
RESULTS	Two doses of vaccine were required to induce detectable antibody titers in most participants .
RESULTS	After 2 doses of an H7N9 formulation containing 15 g of hemagglutinin given without adjuvant , with AS03 adjuvant , or with MF59 adjuvant , the proportion achieving an HIA titer of 40 or higher was 2 % ( 95 % CI , 0 % -7 % ) without adjuvant ( n = 94 ) , 84 % ( 95 % CI , 76 % -91 % ) with AS03 adjuvant ( n = 96 ) , and 57 % ( 95 % CI , 47 % -68 % ) with MF59 adjuvant ( n = 92 ) ( P < .001 for comparison of the AS03 and MF59 schedules ) .
RESULTS	The 2 schedules alternating AS03-and MF59-adjuvanted formulations led to lower geometric mean titers ( GMTs ) of ( 41.5 [ 95 % CI , 31.7-54 .4 ] ; n = 92 ) and ( 58.6 [ 95 % CI , 44.3-77 .6 ] ; n = 96 ) than the group induced by 2 AS03-adjuvanted formulations ( n = 96 ) ( 103.4 [ 95 % CI , 78.7-135 .9 ] ; P < .001 ) but higher GMTs than 2 doses of MF59-adjuvanted formulation ( n = 94 ) ( 29.0 [ 95 % CI , 22.4-37 .6 ] ; P < .001 ) .
CONCLUSIONS	The AS03 and MF59 adjuvants augmented the immune responses to 2 doses of an inactivated H7N9 influenza vaccine , with AS03-adjuvanted formulations inducing the highest titers .
CONCLUSIONS	This study of 2 adjuvants used in influenza vaccine formulations with adjuvant mixed on site provides immunogenicity information that may be informative to influenza pandemic preparedness programs .
BACKGROUND	clinicaltrials.gov Identifier : NCT01942265 .

###24405687
OBJECTIVE	To assess the effect of red blood cell ( RBC ) transfusion on quality of life in acutely anaemic women after postpartum haemorrhage .
METHODS	Randomised non-inferiority trial .
METHODS	Thirty-seven Dutch university and general hospitals .
METHODS	Women with acute anaemia ( haemoglobin 4.8-7 .9 g/dl [ 3.0-4 .9 mmol/l ] 12-24 hours postpartum ) without severe anaemic symptoms or severe comorbidities .
METHODS	Women were allocated to RBC transfusion or non-intervention .
METHODS	Primary outcome was physical fatigue 3 days postpartum ( Multidimensional Fatigue Inventory , scale 4-20 ; 20 represents maximal fatigue ) .
METHODS	Non-inferiority was demonstrated if the physical fatigue difference between study arms was maximal 1.3 .
METHODS	Secondary outcomes were health-related quality of life and physical complications .
METHODS	Health-related quality of life questionnaires were completed at five time-points until 6 weeks postpartum .
RESULTS	In all , 521 women were randomised to non-intervention ( n = 262 ) or RBC transfusion ( n = 259 ) .
RESULTS	Mean physical fatigue score at day 3 postpartum , adjusted for baseline and mode of delivery , was 0.8 lower in the RBC transfusion arm ( 95 % confidence interval : 0.1-1 .5 , P = 0.02 ) and at 1 week postpartum was 1.06 lower ( 95 % confidence interval : 0.3-1 .8 , P = 0.01 ) .
RESULTS	A median of two RBC units was transfused in the RBC transfusion arm .
RESULTS	In the non-intervention arm , 33 women received RBC transfusion , mainly because of anaemic symptoms .
RESULTS	Physical complications were comparable .
CONCLUSIONS	Statistically , non-inferiority could not be demonstrated as the confidence interval crossed the non-inferiority boundary .
CONCLUSIONS	Nevertheless , with only a small difference in physical fatigue and no differences in secondary outcomes , implementation of restrictive management seems clinically justified .

###24868014
OBJECTIVE	The purpose of this randomized double-blinded clinical trial was to test the efficacy and tooth sensitivity promoted by the use of an in-office 15 % H ( 2 ) O ( 2 ) bleaching agent containing nanoparticles of TiO_N photocatalyzed with LED/laser light ( HP15 ) and a control of 35 % H2O2 ( HP35 ) .
METHODS	Forty healthy volunteers , both sexes , aged 18 to 25 yr , were randomly distributed in 2 groups : HP15 ( n = 20 ) was treated in 3 sessions of 48 min each , and HP35 ( n = 20 ) was treated in 3 sessions of 45 min each .
METHODS	The efficacy ( E ) was evaluated by E values measured via reflectance spectroscopy .
METHODS	The tooth sensitivity ( S ) was analyzed by visual analog scale ( low , average , high , very high ) .
METHODS	The absolute risk reduction and the number needed to treat index were calculated .
METHODS	The data were analyzed by mixed repeated measures analysis of variance with Bonferroni-correction t test ( = 0.05 ) .
RESULTS	For the efficacy , significant differences were found for number of bleaching sessions ( p = .0001 ; [ Formula : see text ] = 0.73 and = 1.000 ) and for the interaction of number of sessions and bleaching protocols ( p = .0001 ; [ Formula : see text ] = 0.319 and = 1.000 .
RESULTS	The tooth sensitivity level showed significant differences only between the bleaching protocols .
RESULTS	Absolute risk reduction calculated was 52 % and number needed to treat , 1.92 .
CONCLUSIONS	The bleaching agent with the lower concentration ( HP15 ) promoted lower levels of tooth sensitivity and presented greater efficacy compared to the control ( HP35 ) in patients between 18 and 25 yr old .
CONCLUSIONS	The limitation of short-term evaluation did not provide information about the longevity of the tooth bleaching ( Brazilian Clinical Trials Registry Re Bec no .
CONCLUSIONS	U1111-1150-4466 ) .

###24965569
BACKGROUND	Dysregulation of the hepatocyte growth factor ( HGF ) / MET pathway promotes tumour growth and metastasis .
BACKGROUND	Rilotumumab is a fully human , monoclonal antibody that neutralises HGF .
BACKGROUND	We aimed to assess the safety , efficacy , biomarkers , and pharmacokinetics of rilotumumab combined with epirubicin , cisplatin , and capecitabine ( ECX ) in patients with advanced gastric or oesophagogastric junction cancer .
METHODS	We recruited patients ( 18 years old ) with unresectable locally advanced or metastatic gastric or oesophagogastric junction adenocarcinoma , an Eastern Cooperative Oncology Group ( ECOG ) performance status of 0 or 1 , who had not received previous systemic therapy , from 43 sites worldwide .
METHODS	Phase 1b was an open-label , dose de-escalation study to identify a safe dose of rilotumumab ( initial dose 15 mg/kg intravenously on day 1 ) plus ECX ( epirubicin 50 mg/m ( 2 ) intravenously on day 1 , cisplatin 60 mg/m ( 2 ) intravenously on day 1 , capecitabine 625 mg/m ( 2 ) twice a day orally on days 1-21 , respectively ) , administered every 3 weeks .
METHODS	The phase 1b primary endpoint was the incidence of dose-limiting toxicities in all phase 1b patients who received at least one dose of rilotumumab and completed the dose-limiting toxicity assessment window ( first cycle of therapy ) .
METHODS	Phase 2 was a double-blind study that randomly assigned patients ( 1:1:1 ) using an interactive voice response system to receive rilotumumab 15 mg/kg , rilotumumab 75 mg/kg , or placebo , plus ECX ( doses as above ) , stratified by ECOG performance status and disease extent .
METHODS	The phase 2 primary endpoint was progression-free survival ( PFS ) , analysed by intention to treat .
METHODS	The study is registered with ClinicalTrials.gov , number NCT00719550 .
RESULTS	Seven of the nine patients enrolled in the phase 1b study received at least one dose of rilotumumab 15 mg/kg , only two of whom had three dose-limiting toxicities : palmar-plantar erythrodysesthesia , cerebral ischaemia , and deep-vein thrombosis .
RESULTS	In phase 2 , 121 patients were randomly assigned ( 40 to rilotumumab 15 mg/kg ; 42 to rilotumumab 75 mg/kg ; 39 to placebo ) .
RESULTS	Median PFS was 51 months ( 95 % CI 29-70 ) in the rilotumumab 15 mg/kg group , 68 months ( 45-75 ) in the rilotumumab 75 mg/kg group , 57 months ( 45-70 ) in both rilotumumab groups combined , and 42 months ( 29-49 ) in the placebo group .
RESULTS	The hazard ratio for PFS events compared with placebo was 069 ( 80 % CI 049-097 ; p = 0164 ) for rilotumumab 15 mg/kg , 053 ( 80 % CI 038-073 ; p = 0009 ) for rilotumumab 75 mg/kg , and 060 ( 80 % CI 045-079 ; p = 0016 ) for combined rilotumumab .
RESULTS	Any grade adverse events more common in the combined rilotumumab group than in the placebo group included haematological adverse events ( neutropenia in 44 [ 54 % ] of 81 patients vs 13 [ 33 % ] of 39 patients ; anaemia in 32 [ 40 % ] vs 11 [ 28 % ] ; and thrombocytopenia in nine [ 11 % ] vs none ) , peripheral oedema ( 22 [ 27 % ] vs three [ 8 % ] ) , and venous thromboembolism ( 16 [ 20 % ] vs five [ 13 % ] ) .
RESULTS	Grade 3-4 adverse events more common with rilotumumab included neutropenia ( 36 [ 44 % ] vs 11 [ 28 % ] ) and venous thromboembolism ( 16 [ 20 % ] vs four [ 10 % ] ) .
RESULTS	Serious adverse events were balanced between groups except for anaemia , which occurred more frequently in the combined rilotumumab group ( ten [ 12 % ] vs none ) .
CONCLUSIONS	Rilotumumab plus ECX had no unexpected safety signals and showed greater activity than placebo plus ECX .
CONCLUSIONS	A phase 3 study of the combination in MET-positive gastric and oesophagogastric junction cancer is in progress .
BACKGROUND	Amgen Inc. .

###24641985
BACKGROUND	Laser therapies have been Food and Drug Administration approved for temporary nail plate clearance ; however , there is minimal evidence of their long-term efficacy .
OBJECTIVE	We sought to evaluate the clinical and mycological clearance of toenails treated with 1064-nm neodymium : yttrium-aluminum-garnet laser versus no treatment .
METHODS	This was a randomized , controlled , single-center trial comparing 2 treatments with 1064-nm neodymium : yttrium-aluminum-garnet laser ( fluence of 5 J/cm ( 2 ) , rate of 6 Hz ) spaced 2 weeks apart versus no treatment in 27 patients ( N = 125 affected nails ) with clinical and mycological diagnosis of onychomycosis .
METHODS	At 3 months , patients were assessed with mycological cultures and proximal nail plate measurements .
METHODS	Patients treated with laser were also assessed with proximal nail plate measurements at 12 months .
RESULTS	At 3 months , 33 % of patients treated with laser achieved a negative mycological culture compared with 20 % of the control group ( P = .49 ) , and had more proximal nail plate clearance compared with control subjects ( 0.44 vs 0.15 mm , P = .18 ) , which was not statistically significant .
RESULTS	At 12 months , there was no difference in nail plate clearance between laser versus control subjects ( 0.24 vs 0.15 mm , P = .59 ) .
CONCLUSIONS	Our study was limited by the small sample size and number of treatments .
CONCLUSIONS	There was no significant mycological culture or clinical nail plate clearance with 1064-nm neodymium : yttrium-aluminum-garnet laser compared with control .

###25710759
OBJECTIVE	To evaluate effects of various doses of polyethylene glycol ( PEG ) - conjugated bovine granulocyte colony-stimulating factor ( bG-CSF ) on the incidence of naturally occurring clinical mastitis in periparturient dairy cattle .
METHODS	211 periparturient Holstein cows and heifers .
METHODS	Approximately 7 days before the anticipated date of parturition ( day of parturition = day 0 ) , healthy cattle received SC injections of sterile saline ( 0.9 % NaCl ) solution ( control treatment ) or PEG-bG-CSF at 5 , 10 , or 20 g/kg .
METHODS	Cattle were commingled and housed in a pen with dirt flooring , which was kept wet to maximize the incidence of naturally occurring clinical mastitis .
METHODS	Within 24 hours after parturition , each animal again received the assigned treatment .
METHODS	Mammary glands and milk were visually scored for abnormalities twice daily for 28 days after parturition .
METHODS	Milk samples were aseptically collected from mammary glands with an abnormal appearance or abnormal milk and submitted for microbial culture .
METHODS	Daily milk production was recorded , and milk composition was assessed on days 3 , 5 , 7 , and 10 .
RESULTS	Cattle treated with PEG-bG-CSF at 10 and 20 g/kg had significantly fewer cases of clinical mastitis ( 9/54 and 5/53 , respectively ) , compared with control cattle ( 18/53 ) .
RESULTS	Administration of PEG - bG-CSF did not significantly affect daily milk production or milk composition .
CONCLUSIONS	Results suggested that PEG-bG-CSF was effective for reducing the incidence of naturally occurring clinical mastitis in periparturient dairy cattle .
CONCLUSIONS	Further investigations of the use of PEG-bG-CSF as a potential preventative intervention should be conducted .

###24793816
BACKGROUND	Patients with progressive disease after two or more HER2-directed regimens for recurrent or metastatic breast cancer have few effective therapeutic options .
BACKGROUND	We aimed to compare trastuzumab emtansine , an antibody-drug conjugate comprising the cytotoxic agent DM1 linked to trastuzumab , with treatment of physician 's choice in this population of patients .
METHODS	This randomised , open-label , phase 3 trial took place in medical centres in 22 countries across Europe , North America , South America , and Asia-Pacific .
METHODS	Eligible patients ( 18 years , left ventricular ejection fraction 50 % , Eastern Cooperative Oncology Group performance status 0-2 ) with progressive HER2-positive advanced breast cancer who had received two or more HER2-directed regimens in the advanced setting , including trastuzumab and lapatinib , and previous taxane therapy in any setting , were randomly assigned ( in a 2:1 ratio ) to trastuzumab emtansine ( 36 mg/kg intravenously every 21 days ) or physician 's choice using a permuted block randomisation scheme by an interactive voice and web response system .
METHODS	Patients were stratified according to world region ( USA vs western Europe vs other ) , number of previous regimens ( excluding single-agent hormonal therapy ) for the treatment of advanced disease ( two to three vs more than three ) , and presence of visceral disease ( any vs none ) .
METHODS	Coprimary endpoints were investigator-assessed progression-free survival ( PFS ) and overall survival in the intention-to-treat population .
METHODS	We report the final PFS analysis and the first interim overall survival analysis .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01419197 .
RESULTS	From Sept 14 , 2011 , to Nov 19 , 2012 , 602 patients were randomly assigned ( 404 to trastuzumab emtansine and 198 to physician 's choice ) .
RESULTS	At data cutoff ( Feb 11 , 2013 ) , 44 patients assigned to physician 's choice had crossed over to trastuzumab emtansine .
RESULTS	After a median follow-up of 72 months ( IQR 50-101 months ) in the trastuzumab emtansine group and 65 months ( IQR 41-97 ) in the physician 's choice group , 219 ( 54 % ) patients in the trastuzumab emtansine group and 129 ( 65 % ) of patients in the physician 's choice group had PFS events .
RESULTS	PFS was significantly improved with trastuzumab emtansine compared with physician 's choice ( median 62 months [ 95 % CI 559-687 ] vs 33 months [ 289-414 ] ; stratified hazard ratio [ HR ] 0528 [ 0422-0661 ] ; p < 00001 ) .
RESULTS	Interim overall survival analysis showed a trend favouring trastuzumab emtansine ( stratified HR 0552 [ 95 % CI 0369-0826 ] ; p = 00034 ) , but the stopping boundary was not crossed .
RESULTS	A lower incidence of grade 3 or worse adverse events was reported with trastuzumab emtansine than with physician 's choice ( 130 events [ 32 % ] in 403 patients vs 80 events [ 43 % ] in 184 patients ) .
RESULTS	Neutropenia ( ten [ 2 % ] vs 29 [ 16 % ] ) , diarrhoea ( three [ < 1 % ] vs eight [ 4 % ] ) , and febrile neutropenia ( one [ < 1 % ] vs seven [ 4 % ] ) were grade 3 or worse adverse events that were more common in the physician 's choice group than in the trastuzumab emtansine group .
RESULTS	Thrombocytopenia ( 19 [ 5 % ] vs three [ 2 % ] ) was the grade 3 or worse adverse event that was more common in the trastuzumab emtansine group .
RESULTS	74 ( 18 % ) patients in the trastuzumab emtansine group and 38 ( 21 % ) in the physician 's choice group reported a serious adverse event .
CONCLUSIONS	Trastuzumab emtansine should be considered as a new standard for patients with HER2-positive advanced breast cancer who have previously received trastuzumab and lapatinib .
BACKGROUND	Genentech .

###25386965
BACKGROUND	Because inactivated trivalent influenza vaccines ( TIVs ) contain 1 influenza B strain , whereas 2 lineages may co-circulate , B lineage mismatch is frequent .
BACKGROUND	We assessed an inactivated quadrivalent influenza vaccine ( QIV ) containing both B lineages versus TIV in young children .
METHODS	Children aged 18-47 months who had received 2 doses of TIV in a study during the previous season ( primed cohort , n = 192 ) were randomized 1:1 to receive 1 dose of TIV or QIV , and a further 407 children ( unprimed cohort ) were randomized 1:1 to receive 2 doses of TIV or QIV 28 days apart .
METHODS	Immunogenicity was assessed by hemagglutination-inhibition ( HI ) prevaccination and 28 days after each vaccination .
METHODS	Immunogenic non-inferiority QIV versus TIV for shared strains , and superiority against the alternate-lineage B strain were based on HI geometric mean titers ( pooled analyses of primed and half of unprimed cohort with Day 56 immunogenicity assessment ) .
METHODS	Solicited and unsolicited adverse events were assessed during each 7 - and 28-day postvaccination period , respectively ( NCT00985790 ) .
RESULTS	Non-inferiority for shared strains and superiority for the alternate-lineage B strain unique to QIV was demonstrated for QIV versus TIV .
RESULTS	QIV was immunogenic against all 4 vaccine strains and 87.0 % , 88.6 % , 69.8 % and 97.9 % of children had postvaccination titers of 1:40 against A/H1N1 , A/H3N2 , B/Victoria and B/Yamagata , respectively .
RESULTS	Reactogenicity and safety of QIV was consistent with TIV .
CONCLUSIONS	QIV provided superior immunogenicity for the alternate-lineage B strain compared with TIV without interfering with immune responses to shared strains .
CONCLUSIONS	Further studies are warranted to assess QIVs in children and to establish the clinical benefits of QIV versus TIV .

###24710957
BACKGROUND	Succinylcholine provides rapid onset of neuromuscular blockade and short duration of action , but its administration may be associated with hyperkalemia .
BACKGROUND	Rocuronium is not known to increase potassium concentration , has fast onset of activity , and can be rapidly reversed by sugammadex .
BACKGROUND	This study evaluated changes in plasma potassium concentrations in patients randomized either to rocuronium followed by sugammadex reversal or to succinylcholine in ambulatory surgery .
METHODS	In this multicentre randomized active-controlled study , adult patients undergoing short surgical procedures in an outpatient setting received either rocuronium 0.6 mgkg ( -1 ) for intubation with sugammadex 4.0 mgkg ( -1 ) for reversal ( n = 70 ) or succinylcholine 1.0 mgkg ( -1 ) with spontaneous recovery ( n = 80 ) .
METHODS	Blood potassium concentrations were assessed at baseline ( before study drug administration ) and at intervals up to 15min after rocuronium , sugammadex , and succinylcholine .
RESULTS	At the primary endpoint , five minutes post-administration , the changes in potassium concentrations from baseline were significantly smaller in patients treated with rocuronium than in those given succinylcholine [ mean ( SD ) : -0.06 ( 0.32 ) vs 0.30 ( 0.34 ) mmolL ( -1 ) , respectively ; P < 0.0001 ] .
RESULTS	At baseline , potassium concentrations were similar in both groups , but they were greater at two , five , ten , and 15min after succinylcholine than after rocuronium ( P < 0.0001 ) for all time points .
RESULTS	After sugammadex administration , there were no significant changes in mean potassium concentration from the pre-rocuronium baseline .
RESULTS	No adverse effects related to hyperkalemia were observed .
CONCLUSIONS	Succinylcholine was associated with a modest increase in potassium concentration ; these changes were not seen after rocuronium or sugammadex (
BACKGROUND	NCT00751179 ) .

###24974075
BACKGROUND	Intrathecal morphine is used for post-cesarean analgesia , but pruritus is a common side effect .
BACKGROUND	Ondansetron would be an attractive treatment because it prevents nausea , is non-sedative or has no anti-analgesic effect .
BACKGROUND	We undertook a study to assess the efficacy of ondansetron for treatment or prophylaxis of intrathecal morphine-induced pruritus .
METHODS	Healthy paturients undergoing cesarean delivery with intrathecal morphine 250g and fentanyl 25g were randomized to receive : prophylaxis ( ondansetron 8mg at cord clamping , normal saline 4mL for treatment of pruritus in the post-anaesthesia care unit ) ; treatment ( normal saline 4mL at cord clamping , ondansetron 8mg as required in the post-anesthesia care unit ) or control ( normal saline 4mL in both ) .
METHODS	Visual analogue scale scores for pruritus , nausea and pain were recorded preoperatively , on arrival to , at 30 , 60 , and 120min and on discharge from the post-anesthesia care unit .
METHODS	The primary outcome was the peak pruritus score .
METHODS	ANOVA with Bonferroni correction or Fisher 's exact test were used to analyze data ; P < 0.05 was considered significant .
RESULTS	The study was terminated early when interim analysis indicated no effect .
RESULTS	Eighty-two of the intended 180 paturients completed the protocol ( 26 in control group , 32 in treatment group and 24 in prophylaxis ) .
RESULTS	There were no differences in the rate or severity of pruritus at any assessment point , or the request for treatment .
RESULTS	Pruritus was reduced after administration of treatment syringe .
CONCLUSIONS	Prophylactic ondansetron did not reduce pruritus when compared with placebo .
CONCLUSIONS	The use of ondansetron as a treatment did not decrease the severity of pruritus when compared with placebo .

###25012419
BACKGROUND	An important biological factor suggested in the pathophysiology of ( recurrent ) Major Depressive Disorder ( MDD ) concerns a polymorphism in a gene encoding for the MTHFR-enzyme of the one-carbon ( 1-C ) - metabolism .
BACKGROUND	Integratively investigating key 1-C-components ( folate , homocysteine , vitamin B6 and B12 ) , including the possible effects of antidepressant medication and depressive state , could provide more insight in the possible association between the MTHFR-polymorphism and recurrent MDD .
METHODS	We compared the MTHFR C677T-polymorphism together with the key 1-C-components in clinically ascertained patients with recurrent MDD ( n = 137 ) to age - and gender-matched healthy controls ( n = 73 ) .
RESULTS	First , patients had lower folate ( t = 2.25 ; p = .025 ) as compared to controls ; a difference that resolved after correction for demographics ( t = 1.22 ; p = .223 ) .
RESULTS	Second , patients that were depressed during sampling had lower vitamin B6 ( t = -2.070 ; p = .038 ) and higher homocysteine ( t = 2.404 ; p = .016 ) compared to those in remission .
RESULTS	Finally , current use of antidepressants had no influence on the 1-C-components .
CONCLUSIONS	Despite investigation of a specific recurrently depressed patient population , we found no clear associations with the 1-C-cycle , except for higher homocysteine and lower vitamin B6 during the depressed state .
CONCLUSIONS	This suggests that 1-C-cycle alterations in MDD are state-associated , possibly resulting from high levels of acute ( psychological ) stress , and may provide a treatment target to reduce cardiovascular risk in this population .

###24721903
OBJECTIVE	Although hepatitis delta is considered an immune-mediated disease , adaptive immune responses to hepatitis delta virus ( HDV ) are hardly detectable .
OBJECTIVE	Thus , the role of other immune responses , including those mediated by natural killer ( NK ) cells , must be considered in HDV pathogenesis and in treatments with immune-stimulating agents such as interferon ( IFN ) .
OBJECTIVE	However , the phenotype and function of NK cells in chronic HDV infection , or in HDV-infected individuals undergoing IFN treatment , have not been extensively studied .
METHODS	We performed an extensive analysis of NK cells in chronically HDV-infected patients before and during treatment with IFN , and compared the results with those for patients with HBV mono-infection as well as healthy controls .
RESULTS	In untreated HDV-infected patients , a higher than normal frequency of NK cells was observed in peripheral blood with unaltered phenotypic NK cell differentiation status .
RESULTS	In contrast , long-term IFN treatment of HDV-infected patients caused a significant change in NK cell differentiation status , with selective loss of terminally differentiated NK cells and , in parallel , a relative enrichment in immature NK cell subsets .
RESULTS	Treatment was associated with marked functional impairment of the NK cells , which was independent of the changes in NK cell differentiation status .
RESULTS	Furthermore , treatment polarised NK cell IFN signalling from STAT4 towards STAT1 dependency .
RESULTS	Strikingly , a high frequency of CD56 ( dim ) NK cells at baseline was positively associated with IFN treatment outcome in the patients .
CONCLUSIONS	We describe in detail how HDV infection , and IFN treatment of this infection , affects the NK cell compartment and what consequences this has for the functional capacity of NK cells .

###25008877
OBJECTIVE	To study the effects of erythropoietin ( EPO ) on serum levels of neuron-specific enolase ( NSE ) and S-100B in neonates with hypoxic-ischemic encephalopathy ( HIE ) and the underlying mechanism .
METHODS	Forty neonates with HIE were randomly divided into conventional treatment ( n = 20 ) and EPO treatment groups ( n = 20 ) .
METHODS	Twenty healthy full-term neonates born during the same period were randomly selected as the normal control group .
METHODS	The conventional treatment group received conventional treatment , while the EPO treatment group received conventional treatment as well as EPO [ 200 IU / ( kg.d ) ] which was given by intravenous infusion from the second day after birth .
METHODS	The course of treatment was 7 days .
METHODS	Blood samples of the three groups were collected on the first day after birth ( before treatment ) and the ninth day after birth ( after treatment ) .
METHODS	Serum levels of NSE and S-100B were measured by double-antibody sandwich ABC-ELISA .
RESULTS	Before treatment , the two treatment groups had significantly higher serum NSE and S-100B levels than the normal control group ( P < 0.01 ) , whereas no significant differences in the levels of NSE and S-100B were observed between the conventional treatment and EPO treatment groups ( P > 0.05 ) .
RESULTS	The serum NSE and S-100B levels on the ninth day after birth were significantly lower than those on the first day after birth in the three groups ( P < 0.01 ) .
RESULTS	After treatment , the serum NSE and S-100B levels were significantly lower in the EPO treatment group than in the conventional treatment group ( P < 0.05 ) .
CONCLUSIONS	Dynamic monitoring of serum NSE and S-100B levels may be helpful for the early diagnosis of HIE and the assessment of brain injury repair in newborns with HIE .
CONCLUSIONS	EPO may be helpful for the repair of neurons and glial cells .

###25049195
OBJECTIVE	The aim of this study was to examine the relationship between quality of life ( QoL ) , weight , and eating disorder symptoms across treatment in individuals with severe and enduring anorexia nervosa ( SE-AN ) .
METHODS	Participants were 63 adult females with SE-AN presenting to an outpatient , multisite randomized clinical trial .
METHODS	QoL was assessed using three well-validated QoL questionnaire measures , the EDQOL , SF-12 , and WSAS .
METHODS	Participants ' weight and severity of symptoms was assessed by Eating Disorder Examination ( EDE ) and weekly BMI change .
RESULTS	Predictors of QoL were evaluated in the context of concurrent , prospective ,1 and lagged mixed-effects models .
RESULTS	Changes in both BMI and EDE were found to significantly affect current and future QoL ratings .
CONCLUSIONS	Findings suggest that improvements in QoL may be dependent on symptom change and weight gain .
CONCLUSIONS	Treatments seeking solely to improve QoL may be unlikely to produce lasting change and clinicians should maintain a focus on weight and behavioral symptoms as much as on improvements in QoL .

###24659891
OBJECTIVE	To compare iron depletion to lifestyle changes alone in patients with severe nonalcoholic fatty liver disease ( NAFLD ) and hyperferritinemia , a frequent feature associated with more severe liver damage , despite at least 6 mo of lifestyle changes .
METHODS	Eligible subjects had to be 18-75 years old who underwent liver biopsy for ultrasonographically detected liver steatosis and hyperferritinemia , ferritin levels 250 ng/mL , and NAFLD activity score > 1 .
METHODS	Iron depletion had to be achieved by removing 350 cc of blood every 10-15 d according to baseline hemoglobin values and venesection tolerance , until ferritin < 30 ng/mL and/or transferrin saturation ( TS ) < 25 % .
METHODS	Thirty-eight patients were randomized 1:1 to phlebotomy ( n = 21 ) or lifestyle changes alone ( n = 17 ) .
METHODS	The main outcome of the study was improvement in liver damage according to the NAFLD activity score at 2 years , secondary outcomes were improvements in liver enzymes [ alanine aminotransferases ( ALT ) , aspartate aminotransferase ( AST ) , and gamma-glutamyl-transferases ( GGT ) ] .
RESULTS	Phlebotomy was associated with normalization of iron parameters without adverse events .
RESULTS	In the 21 patients compliant to the study protocol , the rate of histological improvement was higher in iron depleted vs control subjects ( 8/12 , 67 % vs 2/9 , 22 % , P = 0.039 ) .
RESULTS	There was a better improvement in steatosis grade in iron depleted vs control patients ( P = 0.02 ) .
RESULTS	In patients followed-up at two years ( n = 35 ) , ALT , AST , and GGT levels were lower in iron-depleted than in control patients ( P < 0.05 ) .
RESULTS	The prevalence of subjects with improvement in histological damage or , in the absence of liver biopsy , ALT decrease 20 % ( associated with histological improvement in biopsied patients ) was higher in the phlebotomy than in the control arm ( P = 0.022 ) .
RESULTS	The effect of iron depletion on liver damage improvement as assessed by histology or ALT decrease 20 % was independent of baseline AST/ALT ratio and insulin resistance ( P = 0.0001 ) .
CONCLUSIONS	Iron depletion by phlebotomy is likely associated with a higher rate of improvement of histological liver damage than lifestyle changes alone in patients with NAFLD and hyperferritinemia , and with amelioration of liver enzymes .

###24616308
OBJECTIVE	Circulating tumor cell ( CTC ) enumeration has not been prospectively validated in standard first-line docetaxel treatment for metastatic castration-resistant prostate cancer .
OBJECTIVE	We assessed the prognostic value of CTCs for overall survival ( OS ) and disease response in S0421 , a phase III trial of docetaxel plus prednisone with or without atrasentan .
METHODS	CTCs were enumerated at baseline ( day 0 ) and before cycle two ( day 21 ) using CellSearch .
METHODS	Baseline counts and changes in counts from day 0 to 21 were evaluated for association with OS , prostate-specific antigen ( PSA ) , and RECIST response using Cox regression as well as receiver operator characteristic ( ROC ) curves , integrated discrimination improvement ( IDI ) analysis , and regression trees .
RESULTS	Median day-0 CTC count was five cells per 7.5 mL , and CTCs < versus five per 7.5 mL were significantly associated with baseline PSA , bone pain , liver disease , hemoglobin , alkaline phosphatase , and subsequent PSA and RECIST response .
RESULTS	Median OS was 26 months for < five versus 13 months for five CTCs per 7.5 mL at day 0 ( hazard ratio [ HR ] , 2.74 [ adjusting for covariates ] ) .
RESULTS	ROC curves had higher areas under the curve for day-0 CTCs than for PSA , and IDI analysis showed that adding day-0 CTCs to baseline PSA and other covariates increased predictive accuracy for survival by 8 % to 10 % .
RESULTS	Regression trees yielded new prognostic subgroups , and rising CTC count from day 0 to 21 was associated with shorter OS ( HR , 2.55 ) .
CONCLUSIONS	These data validate the prognostic utility of CTC enumeration in a large docetaxel-based prospective cohort .
CONCLUSIONS	Baseline CTC counts were prognostic , and rising CTCs at 3 weeks heralded significantly worse OS , potentially serving as an early metric to help redirect and optimize therapy in this clinical setting .

###24894696
OBJECTIVE	To assess ASIR ( adaptive statistical iterative reconstruction ) technique regarding dose reduction and its impact on image quality in evaluation CTs of potential kidney donors .
METHODS	Between May and November 2013 , a prospective study of 53 assumingly healthy potential kidney donors was conducted .
METHODS	The subjects underwent abdominal evaluation CT prior to the planned explantation of a kidney and were randomly divided into 2 groups : Group A was examined with an ASIR 40 protocol ( n = 26 ) , group B ( n = 27 ) was examined using a standard FBP ( filtered back projection ) protocol .
METHODS	Image quality was assessed both quantitatively ( by obtaining attenuation values in different organ regions and calculating SNR and CNRs ) and qualitatively ( by two observers who evaluated image quality using a 5-point scale system ) .
METHODS	Applied dose was analyzed as CTDIvol ( mGy ) , total DLP ( mGycm ) and effective dose ( mSv ) .
RESULTS	Applied dose in group A was about 26 % lower than in group B ( p < 0.05 ) .
RESULTS	Between both groups , dose determining parameters such as scan length and patients ' body diameter showed no significant difference .
RESULTS	SNR ( signal-to-noise ratio ) was significantly higher in group A ( p < 0.05 ) .
RESULTS	CNRs ( contrast-to-noise ratios ) for different tissues were not significantly different .
RESULTS	Observer rated image quality showed no significant difference .
CONCLUSIONS	ASIR can contribute to a relevant dose reduction without any loss of image quality in CT scans for evaluating potential kidney donors .

###25906556
OBJECTIVE	To observe the effects of cross electro-nape-acupuncture on reflex remodeling of airway protective reflex cough in patients with tracheotomy after cerebral hemorrhage .
METHODS	With the method of completely random design , according to treatment order , 60 patients who received tracheotomy after cerebral hemorrhage accompanied with cough reflex difficulty were randomly divided into a cross electro-nape-acupuncture group and an acupuncture group , 30 cases in each group .
METHODS	Both groups were treated with basic treatment , including anti-inflammation , eliminating phlegm , improving cerebral metabolism and so on .
METHODS	The acupuncture group was treated with acupuncture at Yifeng ( TE 17 ) , Fengchi ( GB 20 ) , Lianquan ( CV 23 ) , Baihui ( GV 20 ) , Touwei ( ST 8 ) , Dicang ( ST 4 ) through Jiache ( ST 6 ) , Hegu ( LI 4 ) , Quchi ( LI 11 ) , and motor area on the affected side , and the needles were retained for 30 min .
METHODS	Based on the treatment of acupuncture group , the cross electro-nape-acupuncture group was additionally treated with cross electro-nape-acupuncture ( continuous wave ) for 30 min per treatment .
METHODS	The treatment was both given twice a day from Monday to Friday and once a day on Saturday and Sun day for 4 weeks .
METHODS	Tracheostomy cough reflex grading score ( TCRGS ) and clinical pulmonary infection score ( CPIS ) were observed before and after treatment in the two groups , and the clinical efficacy of two groups was evaluated .
RESULTS	Compared before the treatment , TCRGS and CPIS were both reduced in two groups ( both P < 0.01 ) ; after treatment , there were significant differences of TCRGS and CPIS between two groups ( both P < 0.01 ) , indicating cross electro-nape-acupuncture group was superior to acupuncture group .
RESULTS	Regarding the effects of cough reflex remodeling , the cured and markedly effective rate was 96.7 % ( 29/30 ) in the cross electro-nape-acupuncture group , which was significantly different from 55.2 % ( 16/29 ) in the acupuncture group ( P < 0.01 ) .
CONCLUSIONS	Cross electro-nape-acupuncture could effectively improve the remodeling of cough reflex and promote the recovery of lung infection in patients with tracheotomy after cerebral hemorrhage , leading to an increased quality of life .

###25671224
OBJECTIVE	The objectives of the paper are to describe characteristics of participants who chose moderation and abstinence drinking goals , and to examine post-treatment drinking outcomes based on patterns of goal choice during a Web-based alcohol intervention for returning U.S. Veterans .
METHODS	We conducted a descriptive secondary analysis of a subsample of 305 of 600 Veterans who participated in a clinical trial of VetChange , an 8-module , cognitive-behavioural intervention .
METHODS	Participants self-selected abstinence or moderation drinking goals , initially at Module 3 , and weekly during subsequent modules .
METHODS	Alcohol use and alcohol-related problems were measured using the Alcohol Use Disorders Identification Test ( AUDIT ) , Quick Drink Screen ( QDS ) , and Short Inventory of Problems ( SIP-2R ) .
RESULTS	Initial goal choices were 86.9 % moderation and 13.1 % abstinence .
RESULTS	Approximately 20 % of participants from each initial choice changed goals during the intervention ; last goal choices were 68.6 % moderation and 31.4 % abstinence .
RESULTS	Participants who initially chose moderation reported higher percent heavy drinking days at baseline ; participants who initially chose abstinence were more likely to report recent substance abuse treatment and were older .
RESULTS	Post-intervention levels of alcohol use and alcohol-related problems were significantly reduced in all goal-choice patterns ( i.e. , Moderation Only , Abstinence Only , Moderation to Abstinence , and Abstinence to Moderation ; all measures p < 0.05 or less ) .
RESULTS	Baseline drinking severity did not differentially relate to outcomes across goal-choice patterns .
CONCLUSIONS	Participants in a Web-based alcohol intervention for returning U.S. Veterans demonstrated improvements in drinking regardless of whether they chose an abstinence or moderation drinking goal , and whether the goal was maintained or changed over the course of the intervention .

###25793955
OBJECTIVE	To assess the effect of the daily ingestion of a mixture of probiotics on the amount of Streptococcus mutans in the oral cavity of preschool-age patients with a high risk of caries .
METHODS	Forty patients , aged between 4 and 6 years , with a high risk of dental caries were included in this pilot study .
METHODS	Patients were randomly assigned to two study groups : the Experimental Group ( A ) included patients who brushed their teeth and used fluoridated toothpaste in addition to consuming probiotics daily , and the Control Group ( B ) inclused patients who brushed their teeth and used fluoridated toothpaste but did not consume probiotics .
METHODS	Using the CariScreen , the microorganism count was determined at different times : baseline , 7 , 14 , 21 and 30 days .
METHODS	To identify the differences between both groups , a Mann-Whitney U test was performed , with a significance level of 0.05 .
RESULTS	It was observed that both groups showed similar microbial counts at the beginning of the trial ( p > 0.05 ) , and a significant decrease in the count at the end of the study was found in the experimental group ( p < 0.05 ) 15 days after suspending ingestion .
CONCLUSIONS	We found a significant reduction of RLU values in preschool children who ingested the tested probiotics in relation to the baseline values and 15 days after ceasing consumption .

###24293371
OBJECTIVE	Aging is associated with an impairment of blood lipids .
OBJECTIVE	The present study investigated the response of blood lipids to resistance exercise in old adults .
OBJECTIVE	The particular aim was to investigate whether the response of blood lipids is associated with changes in body composition of blood lipid medication .
METHODS	Subjects ( N = 236 , 73.7 5.7 years , 58.2 % female ) participated in a 12-week resistance exercise program ( 3 times/week ; 3 sets , 6-8 repetitions at 75-80 % of the 1-repetition maximum ) , designed to increase strength and muscle mass of major muscle groups .
METHODS	Body composition , drug use , triglycerides ( TG ) , total cholesterol ( TC ) , low-density lipoprotein ( LDL ) and high-density lipoprotein ( HDL ) were assessed at baseline and endpoint .
RESULTS	The concentrations of HDL ( -6 mg/dl ) , LDL ( -18 mg/dl ) , TC ( -26 mg/dl ) and TG ( -12 mg/g ) decreased significantly during the study period .
RESULTS	A reduction in fat mass by 1 kg predicted a reduction in TG ( 5.0 mg/dl , P = 0.017 ) and a gain in lean body mass by 1 kg predicted also a reduction in TG ( -4.5 mg/dl , P = 0.023 ) .
RESULTS	The use of blood cholesterol lowering drugs predicted greater reductions in TC ( -16.9 mg/dl , P = 0.032 ) and LDL ( -11.8 mg/dl , P = 0.038 ) during training .
CONCLUSIONS	TG , TC , LDL and HDL decreased significantly after 12 weeks of progressive resistance exercise in old adults .
CONCLUSIONS	Changes in body composition , i.e. , reduction in fat mass and gain in lean body mass improved the blood lipid profile .
CONCLUSIONS	Use of blood lipid lowering drugs was associated with greater reductions in TC and LDL after the training .

###25451897
OBJECTIVE	We explored people 's reasons for , and experiences of , using bolus advisors to determine insulin doses ; and , their likes/dislikes of this technology .
METHODS	42 people with type 1 diabetes who had received instruction in use of bolus advisors during a structured education course were interviewed post-course and 6 months later .
METHODS	Data were analysed thematically .
RESULTS	Participants who considered themselves to have poor mathematical skills highlighted a gratitude for , and heavy reliance on , advisors .
RESULTS	Others liked and chose to use advisors because they saved time and effort calculating doses and/or had a data storage facility .
RESULTS	Follow-up interviews highlighted that , by virtue of no longer calculating their doses , participants could become deskilled and increasingly dependent on advisors .
RESULTS	Some forgot what their mealtime ratios were ; others reported a misperception that , because they were pre-programmed during courses , these parameters never needed changing .
RESULTS	Use of data storage facilities could hinder effective review of blood glucose data and some participants reported an adverse impact on glycaemic control .
CONCLUSIONS	While participants liked and perceived benefits to using advisors , there may be unintended consequences to giving people access to this technology .
CONCLUSIONS	To promote effective use , on-going input and education from trained health professionals may be necessary .

###25461372
OBJECTIVE	Different gonadotropin-releasing-hormone agonist ( GnRH-a ) formulations with different potency and associated side effects , therefore , different compliance and persistence of therapy .
OBJECTIVE	This study was to evaluate the difference of hormonal profile and side effects due to hypoestrogenic status after treatment of leuprorelin and triptorelin in Chinese women with ovarian endometrioma after conservative surgical treatment .
METHODS	A total of 302 women underwent laparoscopic excision of ovarian endometriomas with rASRM III and IV were enrolled in the study.Subjects were randomized into two groups with use of a random table .
METHODS	Twenty two patients dropped out during the study .
METHODS	Thus 142 patients had three doses of i.m. leuprorelin ( group A ) and 138 patients had three doses of i.m. triptorelin ( group B ) at 4 weeks intervals after surgical treatment .
METHODS	Menopausal symptoms were evalutaed using a questionnaire and serum sex hormonal levels were also measured during the follow-up .
RESULTS	At week 4 after the treatment , most of the patients in leuprorelin group have no obvious side effects .
RESULTS	After 9 weeks , bone pain , hot flashes and sweating , and irregular bleeding were the main side effects and showed no difference between the groups .
RESULTS	Anxiety , depression , vaginal dryness , headache , and acne rates were all significantly higher in triptorelin group than in leuprorelin group .
RESULTS	A significant difference in FSH ( p = 0.003 ) , LH ( p = 0.026 ) and E2 ( p = 0.002 ) levels between the groups were observed after 21 days of the GnRHa treatment .
RESULTS	The FSH ( p = 0.021 ) and E2 ( p = 0.033 ) levels remained higher in the leuprorelin group than the triptorelin group after six weeks of treatment , but the difference of LH ( p = 0.917 ) level was no longer discernible .
CONCLUSIONS	Leuprorelin in down-regulating the pituitary-ovarian function was more moderate , and the hormonal levels decrease progressively and gradually , therefore , with lower rate of menopausal symptoms .
CONCLUSIONS	Leuprorelin acetate maybe better tolerated than triptorelin .

###25287262
OBJECTIVE	To determine whether semiautomatic volumetric software can differentiate part-solid from nonsolid pulmonary nodules and aid quantification of the solid component .
METHODS	As per reference standard , 115 nodules were differentiated into nonsolid and part-solid by two radiologists ; disagreements were adjudicated by a third radiologist .
METHODS	The diameters of solid components were measured manually .
METHODS	Semiautomatic volumetric measurements were used to identify and quantify a possible solid component , using different Hounsfield unit ( HU ) thresholds .
METHODS	The measurements were compared with the reference standard and manual measurements .
RESULTS	The reference standard detected a solid component in 86 nodules .
RESULTS	Diagnosis of a solid component by semiautomatic software depended on the threshold chosen .
RESULTS	A threshold of -300 HU resulted in the detection of a solid component in 75 nodules with good sensitivity ( 90 % ) and specificity ( 88 % ) .
RESULTS	At a threshold of -130 HU , semiautomatic measurements of the diameter of the solid component ( mean 2.4 mm , SD 2.7 mm ) were comparable to manual measurements at the mediastinal window setting ( mean 2.3 mm , SD 2.5 mm [ p = 0.63 ] ) .
CONCLUSIONS	Semiautomatic segmentation of subsolid nodules could diagnose part-solid nodules and quantify the solid component similar to human observers .
CONCLUSIONS	Performance depends on the attenuation segmentation thresholds .
CONCLUSIONS	This method may prove useful in managing subsolid nodules .
CONCLUSIONS	Semiautomatic segmentation can accurately differentiate nonsolid from part-solid pulmonary nodules Semiautomatic segmentation can quantify the solid component similar to manual measurements Semiautomatic segmentation may aid management of subsolid nodules following Fleischner Society recommendations Performance for the segmentation of subsolid nodules depends on the chosen attenuation thresholds .

###25072436
OBJECTIVE	Investigate the safety and efficacy of 6 months ' duodenal-jejunal bypass liner ( DJBL ) treatment in comparison with dietary intervention for obesity and type 2 diabetes mellitus ( T2DM ) .
BACKGROUND	The DJBL is a bariatric procedure involving an impermeable sleeve that is delivered endoscopically in the proximal intestine .
BACKGROUND	This procedure not only is less invasive than conventional surgical techniques but also has beneficial effects on obesity and T2DM .
METHODS	A multicenter randomized controlled trial was conducted .
METHODS	Seventy-seven patients with obesity and T2DM were included .
METHODS	Thirty-eight patients were randomized to 6 months ' DJBL treatment in combination with dietary intervention ( 34 successfully implanted , 31 completed the study ) , 39 patients received only dietary intervention ( controls , 35 completed the study ) .
METHODS	Total study duration for both groups was 12 months , including 6 months of post-DJBL removal follow-up .
RESULTS	After 6 months , just before DJBL removal , the DJBL group had lost 32.0 % [ 22.0 % -46.7 % ] of their excess weight versus 16.4 % [ 4.1 % -34.6 % ] in the control group ( P < 0.05 ) .
RESULTS	Glycated hemoglobin A1c levels improved to 7.0 % [ 6.4 % -7.5 % ] in the DJBL group and to 7.9 % [ 6.6 % -8.3 % ] in the control group ( P < 0.05 ) .
RESULTS	In addition , 85.3 % of DJBL patients showed decreased postprandial glucose excursions versus 48.7 % of control patients ( P < 0.05 ) .
RESULTS	At 12 months , excess weight loss of the DJBL group was 19.8 % [ 10.6 % -45.0 % ] versus 11.7 % [ 1.4 % -25.4 % ] in the control group ( P < 0.05 ) .
RESULTS	HbA1c was 7.3 % [ 6.6 % -8.0 % ] versus 8.0 % [ 6.8 % -8.8 % ] , DJBL versus control respectively ( P = ns ) .
CONCLUSIONS	The DJBL is a safe and effective alternative to invasive bariatric procedures .
CONCLUSIONS	Six months of DJBL treatment combined with diet leads to superior weight loss and improvement of T2DM when compared with diet alone .

###25096168
BACKGROUND	Weekly paclitaxel/carboplatin might improve survival in platinum-resistant epithelial ovarian cancer ( EOC ) .
BACKGROUND	We compared efficacy of first-line weekly to three-weekly paclitaxel/cis - or carboplatin ( PCw and PC3w ) induction therapy , followed by either three or six PC3w cycles .
METHODS	In this multicentre , randomised phase III trial with 22 design , patients with FIGO stage IIb-IV EOC were randomised to six cycles PCw ( paclitaxel 90mg/m ( 2 ) , cisplatin 70mg/m ( 2 ) or carboplatin AUC 4 ) or three cycles PC3w ( paclitaxel 175mg/m ( 2 ) , cisplatin 75mg/m ( 2 ) or carboplatin AUC 6 ) , followed by either three or six cycles PC3w .
METHODS	Primary endpoints were progression free survival ( PFS ) and overall survival ( OS ) .
METHODS	Secondary endpoints were response rate ( RR ) and toxicity .
RESULTS	Of 267 eligible patients , 133 received PCw and 134 PC3w .
RESULTS	The first 105 patients received cisplatin , after protocol amendment the subsequent 162 patients received carboplatin .
RESULTS	Weekly cisplatin was less well tolerated than weekly carboplatin .
RESULTS	All PC3w cycles were well tolerated .
RESULTS	At the end of all treatments , RR was 90.8 % with no differences between the treatment arms .
RESULTS	After a follow-up of median 10.3 years ( range 7.1-14 .8 ) , median PFS was 18.5 ( 95 % confidence interval ( CI ) 15.9-21 .0 ) months for PCw and 16.4 ( 95 % CI 13.5-19 .2 ) months for PC3w ( p = 0.78 ) .
RESULTS	Median OS was 44.8 ( 95 % CI 33.1-56 .5 ) months for PCw and 41.1 ( 95 % CI 34.4-47 .7 ) months for PC3w ( p = 0.98 ) .
CONCLUSIONS	There was no benefit in terms of OS , PFS or RR for a weekly regimen nor for extended chemotherapy as first-line treatment for EOC in European patients .

###25189328
OBJECTIVE	To assess the effect of the Health Belief Model ( HBM ) on the education of mothers for promoting safety and preventing injury among children aged < 5 years .
METHODS	Randomized controlled trial .
METHODS	This study was conducted in Hamadan City , West Iran in 2012 .
METHODS	One hundred and twenty mothers participated in this study , divided into intervention and control groups ( 60 mothers in each group ) .
METHODS	The intervention group participated in an educational programme consisting of four 1-hour sessions twice per week .
METHODS	The education programme was based on the HBM .
METHODS	The participants of both groups were evaluated before the intervention and two months after the intervention using a questionnaire .
METHODS	The validity and reliability of the questionnaire were tested with a pilot study .
METHODS	The questionnaire consisted of three parts : demographic characteristics ; knowledge , practices and HBM constructs ( perceived sensitivity , perceived severity , perceived benefits , perceived barriers , cues to action and self-efficacy ) ; and history of recent injuries to the child .
METHODS	Student 's t-test was used to compare the mean differences , and P < 0.05 was considered to indicate significance .
RESULTS	None of the 120 participants dropped out of the study .
RESULTS	The mean differences in knowledge , perceived susceptibility , perceived severity , perceived benefits , perceived barriers , cues to action , self-efficacy and practices after the intervention , between the two groups , were 3.98 , 3.57 , 3.97 , 1.57 , -7.08 , 0.82 , 2.95 and 2.47 , respectively .
RESULTS	All differences were statistically significant ( P = 0.001 ) .
CONCLUSIONS	Educational programmes based on the HBM can be used as an effective approach in planning and developing preventive programmes for injury prevention and safety promotion in children aged < 5 years .

###25059747
OBJECTIVE	To investigate whether surgery by open reduction and internal fixation provides benefit compared with non-operative treatment for displaced , intra-articular calcaneal fractures .
METHODS	Pragmatic , multicentre , two arm , parallel group , assessor blinded randomised controlled trial ( UK Heel Fracture Trial ) .
METHODS	22 tertiary referral hospitals , United Kingdom .
METHODS	151 patients with acute displaced intra-articular calcaneal fractures randomly allocated to operative ( n = 73 ) or non-operative ( n = 78 ) treatment .
METHODS	The primary outcome measure was patient reported Kerr-Atkins score for pain and function ( scale 0-100 , 100 being the best possible score ) at two years after injury .
METHODS	Secondary outcomes were complications ; hindfoot pain and function ( American Orthopaedic Foot and Ankle Society score ) ; general health ( SF-36 ) ; quality of life ( EQ-5D ) ; clinical examination ; walking speed ; and gait symmetry .
METHODS	Analysis was by intention to treat .
RESULTS	95 % follow-up was achieved for the primary outcome ( 69 in operative group and 74 in non-operative group ) , and a complete set of secondary outcomes were available for 75 % of participants .
RESULTS	There was no significant difference in the primary outcome ( mean Kerr-Atkins score 69.8 in operative group v 65.7 in non-operative group ; adjusted 95 % confidence interval of difference -7.1 to 7.0 ) or in any of the secondary outcomes between treatment groups .
RESULTS	Complications and reoperations were more common in those who received operative care ( estimated odds ratio 7.5 , 95 % confidence interval 2.0 to 41.8 ) .
CONCLUSIONS	Operative treatment compared with non-operative care showed no symptomatic or functional advantage after two years in patients with typical displaced intra-articular fractures of the calcaneus , and the risk of complications was higher after surgery .
CONCLUSIONS	Based on these findings , operative treatment by open reduction and internal fixation is not recommended for these fractures.Trial registration Current Controlled Trials ISRCTN37188541 .

###24973171
BACKGROUND	Discriminating neoplastic from non-neoplastic polyps can significantly reduce the cost of colonoscopy .
BACKGROUND	The American Society for Gastrointestinal Endoscopy ( ASGE ) recently set threshold levels for optical diagnostic accuracy to be acceptable for clinical use .
OBJECTIVE	In this study , we compare a novel colonoscope capable of dual-focus imaging with standard colonoscopy with respect to the ASGE guidelines .
METHODS	An academic medical center ambulatory surgical center .
METHODS	Patients at average risk were randomized to standard colonoscopy ( Olympus CF-H180 and Exera II 180 colonoscopes , Olympus America , Center Valley , Pa ) or dual-focus colonoscopy ( Olympus CF-HQ190 and Exera III 190 colonoscopes , Olympus America ) .
METHODS	All polyps were given an optical diagnosis and compared with histology .
RESULTS	A total of 600 patients were consented and 522 completed all aspects of the procedure .
RESULTS	A total of 927 polyps were analyzed .
RESULTS	Optical diagnostic accuracy was 79 % ( 95 % confidence interval , 74 % -83 % ) for the 190 and 77 % ( 95 % confidence interval , 73 % -81 % ) for the 180 colonoscope .
RESULTS	Adenoma detection rates were also similar between the 2 groups ( 50 % for the 190 vs 52 % for the 180 colonoscope ) .
RESULTS	For small distal rectosigmoid polyps with a high confidence diagnosis , the negative predictive value for adenoma was 96 % ( range 89 % -99 % ) for the 180 in the narrow-band imaging ( NBI ) mode and 97 % ( range 88 % -99 % ) for the 190 colonoscope in NBI mode .
RESULTS	Agreement of surveillance intervals by using optical diagnosis was 94 % to 95 % for all modalities ( 180 and 190 colonoscopes , white light imaging , NBI ) .
CONCLUSIONS	Our study evaluated the accuracy of the 180 and 190 colonoscopes at a center with already-established expertise in endoscopic imaging .
CONCLUSIONS	Both traditional and new dual-focus colonoscopes provide highly accurate optical polyp discrimination .
CONCLUSIONS	There was no difference between the 2 systems in terms of discrimination or adenoma detection .
CONCLUSIONS	Both systems are consistent with ASGE guidelines for optical diagnosis of selected colorectal polyps without histological confirmation .

###24982457
OBJECTIVE	A major concern with sublobar resection ( SR ) for non-small-cell lung cancer ( NSCLC ) is high local recurrence ( LR ) .
OBJECTIVE	Adjuvant brachytherapy may reduce LR This multicenter randomized trial compares SR to SR with brachytherapy ( SRB ) .
METHODS	High-risk operable patients with NSCLC 3 cm were randomly assigned to SR or SRB .
METHODS	The primary end point was time to LR , where LR included recurrence at the staple line ( local progression ) , in the primary tumor lobe away from the staple line , and in ipsilateral hilar nodes .
METHODS	The trial was designed to have a 90 % power to detect a hazard ratio ( HR ) of 0.315 in favor of SRB , using a one-sided type I error rate of 0.05 with a sample size of 100 eligible patients in each arm .
RESULTS	Two hundred twenty-four patients were randomly assigned ; 222 patients were evaluable for intent-to-treat analysis .
RESULTS	Median age was 71 years ( range , 49 to 87 years ) .
RESULTS	No differences were found in baseline characteristics .
RESULTS	Median follow-up time was 4.38 years ( range , 0.04 to 5.59 years ) .
RESULTS	There was no difference in time to LR ( HR , 1.01 ; 95 % CI , 0.51 to 1.98 ; log-rank P = .98 ) or in the types of LR .
RESULTS	Local progression occurred in only 17 ( 7.7 % ) of 222 patients .
RESULTS	In patients with potentially compromised margins ( margin < 1 cm , margin-to-tumor ratio < 1 , positive staple line cytology , wedge resection , nodule size > 2.0 cm ) , SRB did not reduce LR , although trends favored the SRB arm .
RESULTS	This was most marked in 14 patients with positive staple line cytology ( HR , 0.22 ; P = .24 ) .
RESULTS	Three-year overall survival rates were similar for patients in the SR ( 71 % ) and SRB ( 71 % ) arms ( P = .97 ) .
CONCLUSIONS	Brachytherapy did not reduce LR after SR. .
CONCLUSIONS	This finding may have been related to closer attention to parenchymal margins by surgeons participating in this study .

###25291499
OBJECTIVE	To investigate if short-term treatment with dutasteride ( 8 weeks ) before bipolar transurethral resection of the prostate ( B-TURP ) can reduce intraoperative bleeding , as dutasteride a dual 5-reductase inhibitor ( 5-ARI ) blocks the conversion of testosterone into its active form dihydrotestosterone ( DHT ) , and reduces prostate volume and prostate-specific antigen ( PSA ) levels , while increasing urinary flow rate .
METHODS	In all , 259 patients were enrolled and randomised to two groups : Group A , receiving placebo and Group B , receiving dutasteride ( 0.5 mg daily for 8 weeks ) .
METHODS	Blood samples were taken before and after B-TURP for serum chemistry evaluation .
METHODS	In particular we evaluated blood parameters associated with blood loss [ haemoglobin ( Hb ) and haematocrit ( Ht ) ] and prostate vascularity [ vascular endothelial growth factor ( VEGF ) immunoreactivity and microvessel density ( MVD ) using cluster of differentiation 34 ( CD34 ) immunoreactivity ] .
RESULTS	Total testosterone , DHT , PSA level and prostate volume were evaluated and with the exception of DHT and PSA level there was no statistically significant differences between the groups .
RESULTS	When comparing changes in Hb and Ht between Group A and Group B before and after B-TURP , there was a statistically significant difference only in patients with large prostates of 50mL ( Hb 3.86 vs 2.05 g/dL and Ht 4.98 vs 2.64 % , in Groups A and B , respectively ) .
RESULTS	There was no significant difference in MVD and VEGF index in prostates of < 50mL , conversely in large prostates the difference become statistically significant .
CONCLUSIONS	Dutasteride was able to reduce operative and perioperative bleeding only in patients with large prostates ( 50mL ) that underwent B-TURP .
CONCLUSIONS	Our findings are confirmed by Hb and Ht values reported before and after the B-TURP and reductions in the molecular markers for VEGF and CD34 in the dutasteride-treated specimens .

###25465826
BACKGROUND	Given the rising prevalence of heart failure ( HF ) , our objective is to explore the relationships between meteorological events and acute HF ( AHF ) globally .
METHODS	We used data from 30 countries participating in the ASCEND-HF trial .
METHODS	Parameters including temperature were normalized by location for the 37 days prior to the HF event .
METHODS	Meteorological events were classified as a change that occurred < 10 % compared to baseline .
METHODS	The 7 days prior to the HF event was subdivided : T1 : the day of and -1 day ; T2 : 2 and 3 days ; T3 : 4 and 5 days ; and T4 : 6 and 7 days .
METHODS	Results are reported as ratios of observed to expected weather events at the time of AHF presentation .
RESULTS	From 7141 patients , median age was 67 ( IQR 56-76 ) with 66 % male patients and 60 % of patients with ischemic cardiomyopathy .
RESULTS	In T1 , temperatures were warmer than expected with 10 % fewer decreases in average [ OR 0.91 95 % CI ( 0.83-0 .98 ) ] and minimum [ OR 0.90 95 % CI ( 0.82-0 .97 ) ] temperature .
RESULTS	In T2 , temperatures were again warmer than expected with an excess number of increases in maximum [ OR 1.18 95 % CI ( 1.06-1 .30 ) ] and average [ OR 1.21 95 % CI ( 1.10-1 .32 ) ] temperature .
RESULTS	In T4 temperatures were cooler than baseline with fewer increases [ OR 0.84 95 % CI ( 0.74-0 .95 ) ] in average temperature .
CONCLUSIONS	Meteorological fluctuations appear most relevant in the 3 days ( T1 and T2 ) prior to the HF hospitalization with temperature demonstrating a bidirectional relationship with AHF .
CONCLUSIONS	Continued validation of biometeorological trends in HF will contribute to healthcare system planning globally .

###25438394
OBJECTIVE	This study aims to determine the frequency of behaviour change and related factors generated in the population through the `` Fighting Obesity Campaign '' of the Turkish Ministry of Health .
METHODS	Twelve statistical regions from NUTS-1 and 18 provinces were selected for the study sample .
METHODS	At least one province from each region was randomly selected , and stratawere defined as urban or rural .
METHODS	Of the sample selected , 2,038 respondents completed a face-to-face survey .
METHODS	Logistic regression analysis was used to analyse the data .
METHODS	Changing behaviour as result of the campaign was defined as the dependent variable .
METHODS	Behaviour change was defined as an individual taking at least one action to increase physical activity , calculate her/his Body Mass Index ( BMI ) or minimise meal portions .
RESULTS	Of the sample selected , 84 % of participants lived in urban areas .
RESULTS	Of total sample selected , 49.8 % were men and 50.2 % were women .
RESULTS	According to BMI categorisation , 41.4 % of participants were underweight or normal weight , 34.3 % were overweight and 24.3 % were obese .
RESULTS	Of the total participants , 85.2 % learned about the `` Fighting-Obesity Campaign '' through television , 28.1 % through radio , 11.0 % from newspapers , 6.0 % from billboards , and 19.2 % from other sources .
RESULTS	This study revealed that 28.5 % of the participants adopted desired behavioural changes after exposure to the campaign .
RESULTS	Logistic regression results demonstrated that behaviour change is greater among women , individuals living in urban settings , group of persons approving public spots , obese individuals , and among the 20-39 age group .
CONCLUSIONS	Media campaigns may cause behavioural changes by increasing motivation to prevent obesity within the target population .
CONCLUSIONS	Con - tinuing these campaigns can lead to success at the national level .

###24508320
BACKGROUND	Antipsychotic drugs are usually the first line of treatment for schizophrenia ; however , many patients refuse or discontinue their pharmacological treatment .
BACKGROUND	We aimed to establish whether cognitive therapy was effective in reducing psychiatric symptoms in people with schizophrenia spectrum disorders who had chosen not to take antipsychotic drugs .
METHODS	We did a single-blind randomised controlled trial at two UK centres between Feb 15 , 2010 , and May 30 , 2013 .
METHODS	Participants aged 16-65 years with schizophrenia spectrum disorders , who had chosen not to take antipsychotic drugs for psychosis , were randomly assigned ( 1:1 ) , by a computerised system with permuted block sizes of four or six , to receive cognitive therapy plus treatment as usual , or treatment as usual alone .
METHODS	Randomisation was stratified by study site .
METHODS	Outcome assessors were masked to group allocation .
METHODS	Our primary outcome was total score on the positive and negative syndrome scale ( PANSS ) , which we assessed at baseline , and at months 3 , 6 , 9 , 12 , 15 , and 18 .
METHODS	Analysis was by intention to treat , with an ANCOVA model adjusted for site , age , sex , and baseline symptoms .
METHODS	This study is registered as an International Standard Randomised Controlled Trial , number 29607432 .
RESULTS	74 individuals were randomly assigned to receive either cognitive therapy plus treatment as usual ( n = 37 ) , or treatment as usual alone ( n = 37 ) .
RESULTS	Mean PANSS total scores were consistently lower in the cognitive therapy group than in the treatment as usual group , with an estimated between-group effect size of -6.52 ( 95 % CI -10.79 to -2.25 ; p = 0.003 ) .
RESULTS	We recorded eight serious adverse events : two in patients in the cognitive therapy group ( one attempted overdose and one patient presenting risk to others , both after therapy ) , and six in those in the treatment as usual group ( two deaths , both of which were deemed unrelated to trial participation or mental health ; three compulsory admissions to hospital for treatment under the mental health act ; and one attempted overdose ) .
CONCLUSIONS	Cognitive therapy significantly reduced psychiatric symptoms and seems to be a safe and acceptable alternative for people with schizophrenia spectrum disorders who have chosen not to take antipsychotic drugs .
CONCLUSIONS	Evidence-based treatments should be available to these individuals .
CONCLUSIONS	A larger , definitive trial is needed .
BACKGROUND	National Institute for Health Research .

###24709499
OBJECTIVE	To investigate the role of Xuebijing injection in inhibiting perioperative inflammatory responses and protecting the function of multiple organs .
METHODS	A single-blind , randomized , parallel controlled trial was conducted .
METHODS	60 patients in the First Affiliated Hospital of Zhejiang University School of Medicine , aged 18 to 80 years , ASA gradeI-III , undergoing elective abdominal surgery , were enrolled .
METHODS	The patients were randomly divided into the control group ( n = 30 ) and the treatment group ( n = 30 ) .
METHODS	In the control group , after induction of anesthesia , a continuous infusion of 0.9 % normal saline ( NS ) 200 mL was given in a speed of 2 mL/min , while a continuous infusion of Xuebijing 2 mL/kg in 100 mL of 0.9 % NS was given at 2 mL/min in the treatment group after induction of anesthesia .
METHODS	The blood sample was drawn , and body temperature , routine blood test , C-reactive protein ( CRP ) , liver and kidney function , fasting glucose ( Glu ) , and serum interleukin-6 ( IL-6 ) , high mobility group protein B1 ( HMGB1 ) levels were determined in all the patients before anesthesia ( T1 ) , at the end of operation ( T2 ) , 12 hours after operation ( T3 ) , or at 5:00 am on the third day after operation ( T4 ) .
METHODS	At the same time the adverse reactions were recorded for evaluation of the safety of Xuebijing .
RESULTS	After using Xuebijing injection , T3 body temperature and the T3-T1 temperature difference in treatment group were significantly lower than those of the control group ( 36.700.37 centigrade vs. 37.380.47 centigrade , t = 6.199 , P = 0.000 ; 0.070.50 vs. 0.850.58 , t = 5.598 , P = 0.000 ) .
RESULTS	Postoperative white blood cell count , neutrophil percentage , and CRP were significantly higher than those before the operation , but the differences between two groups were not statistically significant .
RESULTS	Compared with the control group , alanine aminotransferase ( ALT ) , aspartate transaminase ( AST ) , total bilirubin ( TBil ) levels at T3 of treatment group were significantly reduced ( ALT : 17.569.80 U/L vs. 88.60179.76 U/L , AST : 27.5313.12 U/L vs. 84.16151.14 U/L , TBil : 15.469.79 mol/L vs. 25.6325.33 mol/L , all P < 0.05 ) .
RESULTS	Difference of conjugated bilirubin ( CB ) , blood urea nitrogen ( BUN ) , creatinine ( Cr ) , Glu was not statistically significant between two groups .
RESULTS	IL-6 showed an increasing trend after the operation in both groups , and IL-6 level at T2 of the treatment group was significantly lower than that of the control group ( 41.4259.74 ng/L vs. 124.84119.66 ng/L , t = 3.405 , P = 0.001 ) .
RESULTS	The HMGB1 level of two groups at T4 were lower than those at T1 , but it decreased significantly only in treatment group ( 22.0315.73 g/L vs. 45.0933.79 g/L , P < 0.05 ) , and there was no significant difference between two groups .
RESULTS	No serious adverse events occurred during the clinical trial .
CONCLUSIONS	Application of Xuebijing injection during anesthesia can significantly diminish postoperative inflammatory injury , which plays an important role in the protection of liver function , helps restore organ function and improve prognosis , and it is safe and effective .

###25081651
BACKGROUND	Tiotropium , a once-daily long-acting anticholinergic agent , has been shown to be an efficacious and safe add-on treatment for adults with symptomatic asthma , despite treatment with inhaled corticosteroids ( ICS ) .
BACKGROUND	A large proportion of asthmatic adolescents have symptomatic disease despite a wide range of therapeutic options .
BACKGROUND	We investigated the efficacy and safety of three doses of tiotropium , administered in the evening ( via Respimat ( ) SoftMist inhaler ) , versus placebo in asthmatic adolescents symptomatic despite ICS treatment .
METHODS	This randomised , double-blind , placebo-controlled , incomplete crossover study evaluated once-daily tiotropium 5g , 2.5 g and 1.25 g versus placebo in three 4-week treatment periods .
METHODS	Primary efficacy end point was change in peak forced expiratory volume in 1swithin 3hpost-dose from baseline ( peak FEV1 ( 0-3h ) ) .
RESULTS	From 139 enrolled patients , 105 were randomised to receive one of four treatment sequences .
RESULTS	Peak FEV1 ( 0-3h ) response for tiotropium 5g was significantly greater versus placebo ( p = 0.0043 ) .
RESULTS	Trough FEV1 responses were significantly greater for tiotropium 5g ( p < 0.00001 ) and 1.25 g ( p = 0.0134 ) versus placebo , but not for 2.5 g ( p = 0.0975 ) , while FEV1 area under the curve ( 0-3h ) responses were significant for all doses ( p = 0.00001-0 .0398 ) .
RESULTS	Overall incidence of adverse events was balanced across treatment groups , with no dose-dependent observations .
RESULTS	The majority of adverse events were mild to moderate in intensity .
CONCLUSIONS	This first study of tiotropium in adolescents with symptomatic asthma demonstrates that tiotropium is well tolerated and efficacious as add-on to maintenance treatment with ICS .
CONCLUSIONS	ClinicalTrials.gov identifier ; NCT01122680 .

###24334573
OBJECTIVE	Statins prevent cardiovascular events in patients with coronary artery disease ( CAD ) .
OBJECTIVE	However , there is little information regarding the vascular effects of statins on arterial wall stiffness in CAD patients .
METHODS	A total of 36 patients were randomly assigned to receive rosuvastatin ( 10 mg per day ) or simvastatin/ezetimibe ( 10/10 mg per day ) for eight weeks .
METHODS	The aim of the present study was to determine the effects of rosuvastatin or simvastatin/ezetimibe on arterial wall stiffness measured according to the brachial and ankle pulse wave velocity ( baPWV ) in CAD patients .
RESULTS	Both treatments significantly improved the levels of total cholesterol ( TC ) , triglycerides ( TGs ) , low-density lipoprotein cholesterol ( LDL-C ) and high-sensitivity C-reactive protein ( hs-CRP ) ( p < 0.05 ) .
RESULTS	The ROCK activity and baPWV were significantly improved in the rosuvastatin group compared with that observed in the simvastatin/ezetimibe group ( p < 0.05 ) .
RESULTS	The changes in baPWV were significantly correlated with the changes in the ROCK activity ( r = 0.488 , p < 0.01 ) , but not with the changes in the lipid profile or the hs-CRP level .
CONCLUSIONS	Compared with simvastatin/ezetimibe ( 10/10 mg ) , rosuvastatin ( 10 mg ) appears to more effectively improve arterial wall stiffness that may be mediated by modulation of the ROCK activity .

###26267985
BACKGROUND	Vitamin D deficiency/insufficiency is common in chronic kidney disease ( CKD ) patients and it contributes to secondary hyperparathyroidism , which occurs early in CKD .
BACKGROUND	It is not clear whether the Kidney Disease Outcomes Quality Initiative ( K/DOQI ) recommended doses of ergocalciferol are adequate for correction of vitamin D insufficiency and hyperparathyroidism .
OBJECTIVE	To evaluate the parathyroid hormone ( PTH ) - lowering effect , safety , and tolerability of high-dose ergocalciferol compared with conventional-dose ergocalciferol in CKD subjects .
METHODS	We enrolled CKD stage III-IV patients who had 25-hydroxyvitamin D ( 25-OH-D ) level < 30 ng/mL .
METHODS	The patients were randomized into two groups , control group treated with ergocalciferol as recommended by K/DOQI guidelines , and treatment group treated with double dosage of ergocalciferol from the recommendation .
METHODS	We compared serum 25-OH-D , intact-PTH , phosphate , calcium , and bone biomarker levels , during the 8-week intervention .
RESULTS	Sixty-eight patients were included ( 34 controls and 34 treatments ) .
RESULTS	Baseline characteristics of both groups were similar except calcium level 9.12 0.56 mg/dL in control group and 9.44 0.38 mg/dL in treatment group ( p = 0.009 ) , but not clinically significant .
RESULTS	At the end of the 8-week , the mean 25-OH-D level significantly increased from 20.99 6.68 to 33.41 8.92 ng/mL in the treatment group ( p = 0.001 ) and increased from 20.84 7.21 to 23.42 7.89 ng/mL in the control group ( p = 0.026 ) .
RESULTS	There was also a significantly greater increase of 25-OH-D levels in the treatment group .
RESULTS	Additionally , PTH levels significantly decreased from 90.75 67.12 to 76.40 45.97 at 8 weeks ( p = 0.024 ) in the treatment group , and there was no change in the control group ( 97.14 83.52 vs. 101.13 95.03 pg/mL , p = 0.546 ) .
RESULTS	Serum calcium , phosphate , and adverse effects did not significantly change in either group throughout the study .
CONCLUSIONS	In addition to improving vitamin D levels , oral high-dose ergocalciferol was safe and had a beneficial effect in decreasing PTH in patients with stage III-IV of CKD .

###25378507
BACKGROUND	There is a paucity of articles in the surgical literature demonstrating transfer validity ( transfer of training ) .
BACKGROUND	The purpose of this study was to assess whether skills learned on the ArthroSim virtual-reality arthroscopic knee simulator transferred to greater skill levels in the operating room .
METHODS	Postgraduate year-3 orthopaedic residents were randomized into simulator-trained and control groups at seven academic institutions .
METHODS	The experimental group trained on the simulator , performing a knee diagnostic arthroscopy procedure to a predetermined proficiency level based on the average proficiency of five community-based orthopaedic surgeons performing the same procedure on the simulator .
METHODS	The residents in the control group continued their institution-specific orthopaedic education and training .
METHODS	Both groups then performed a diagnostic knee arthroscopy procedure on a live patient .
METHODS	Video recordings of the arthroscopic surgery were analyzed by five pairs of expert arthroscopic surgeons blinded to the identity of the residents .
METHODS	A proprietary global rating scale and a procedural checklist , which included visualization and probing scales , were used for rating .
RESULTS	Forty-eight ( 89 % ) of the fifty-four postgraduate year-3 residents from seven academic institutions completed the study .
RESULTS	The simulator-trained group averaged eleven hours of training on the simulator to reach proficiency .
RESULTS	The simulator-trained group performed significantly better when rated according to our procedural checklist ( p = 0.031 ) , including probing skills ( p = 0.016 ) but not visualization skills ( p = 0.34 ) , compared with the control group .
RESULTS	The procedural checklist weighted probing skills double the weight of visualization skills .
RESULTS	The global rating scale failed to reach significance ( p = 0.061 ) because of one extreme outlier .
RESULTS	The duration of the procedure was not significant .
RESULTS	This lack of a significant difference seemed to be related to the fact that residents in the control group were less thorough , which shortened their time to completion of the arthroscopic procedure .
CONCLUSIONS	We have demonstrated transfer validity ( transfer of training ) that residents trained to proficiency on a high-fidelity realistic virtual-reality arthroscopic knee simulator showed a greater skill level in the operating room compared with the control group .
CONCLUSIONS	We believe that the results of our study will stimulate residency program directors to incorporate surgical simulation into the core curriculum of their residency programs .

###24717713
OBJECTIVE	Dental sealant materials may intraorally release their components , including bisphenol-A ( BPA ) , but long-term health effects are uncertain .
OBJECTIVE	The New England Children 's Amalgam Trial ( NECAT ) found that composite restorations were associated with psychosocial , but not neuropsychological or physical , outcomes .
OBJECTIVE	The previous analysis did not consider sealants and preventive resin restorations ( PRRs ) , which were routinely placed .
OBJECTIVE	The purpose of this analysis was to examine sealant/PRR exposure in association with psychosocial and other health outcomes .
METHODS	NECAT recruited 534 six - to 10-year-olds and provided dental care during a five-year follow-up .
METHODS	Annually , examiners conducted psychosocial and neuropsychological tests and measured body mass index ( BMI ) and fat percentage ( BF % ) .
METHODS	Associations between surface years ( SY ) of sealants/PRRs and outcomes were tested using multivariable models .
RESULTS	Cumulative exposure level to sealants and/or PRRs was not associated with psychosocial assessments ( eg , total problems : Child Behavior Checklist , 10-SY = -0.2 0.3 , P = .60 ) or neuropsychological tests ( eg , full-scale IQ , 10-SY = 0.1 0.2 , P = .60 ) .
RESULTS	There were no associations for changes in BMI-for-age z-score ( P = .40 ) , BF % ( girls 10-SY = -0.2 0.3 ; boys 10-SY = -0.1 0.3 ) , or menarche ( 10-SY hazard ratio = 0.91 , 95 % confidence interval = 0.83-1 .01 , P = .08 ) .
CONCLUSIONS	This study showed no associations between exposure level of dental sealants or PRRs and behavioral , neuropsychological , or physical development in children over 5-years .

###25597369
OBJECTIVE	To examine the effectiveness of intramuscular ( IM ) midazolam versus intravenous ( IV ) lorazepam for the treatment of pediatric patients with status epilepticus ( SE ) in the prehospital care setting .
METHODS	This multicenter clinical trial randomized patients diagnosed with SE to receive either IM midazolam or IV lorazepam administered by paramedics in the prehospital care setting .
METHODS	Included in this secondary analysis were only patients younger than 18 years of age .
METHODS	Evaluated were the associations of the treatment group ( IM vs. IV ) with the primary outcome , defined as seizure cessation prior to emergency department ( ED ) arrival , and with patient characteristics , time to important events , and adverse events .
METHODS	Descriptive statistics and 99 % confidence intervals ( CIs ) were used for the analysis .
RESULTS	Of 893 primary study subjects , 120 met criteria for this study ( 60 in each treatment group ) .
RESULTS	There were no differences in important baseline characteristics or seizure etiologies between groups .
RESULTS	The primary outcome was met in 41 ( 68.3 % ) and 43 ( 71.7 % ) of subjects in the IM and IV groups , respectively ( risk difference [ RD ] -3.3 % , 99 % CI -24.9 % to 18.2 % ) .
RESULTS	Similar results were noted for those younger than 11 years ( RD -1.3 % , 99 % CI -25.7 % to 23.1 % ) .
RESULTS	Time from initiating the treatment protocol was shorter for children who received IM midazolam , mainly due to the shorter time to administer the active treatment .
RESULTS	Safety profiles were similar .
CONCLUSIONS	IM midazolam can be rapidly administered and appears to be safe and effective for the management of children with SE treated in the prehospital setting .
CONCLUSIONS	The results must be interpreted in the context of the secondary analysis design and sample size of the study .

###25652804
BACKGROUND	Recurrent or persistent low back pain is common after back surgery but is typically not well controlled .
BACKGROUND	Previous randomised controlled trials on non-acute pain after back surgery were flawed .
BACKGROUND	In this article , the design and protocol of a randomised controlled trial to treat pain and improve function after back surgery are described .
METHODS	This study is a pilot randomised , active-controlled , assessor-blinded trial .
METHODS	Patients with recurring or persistent low back pain after back surgery , defined as a visual analogue scale value of 50mm , with or without leg pain , will be randomly assigned to an electroacupuncture-plus-usual-care group or to a usual-care-only group .
METHODS	Patients assigned to both groups will have usual care management , including physical therapy and patient education , twice a week during a 4-week treatment period that would begin at randomisation .
METHODS	Patients assigned to the electroacupuncture-plus-usual-care group will also have electroacupuncture twice a week during the 4-week treatment period .
METHODS	The primary outcome will be measured with the 100mm pain visual analogue scale of low back pain by a blinded evaluator .
METHODS	Secondary outcomes will be measured with the EuroQol 5-Dimension and the Oswestry Disability Index .
METHODS	The primary and secondary outcomes will be measured at 4 and 8weeks after treatment .
BACKGROUND	Written informed consent will be obtained from all participants .
BACKGROUND	This study was approved by the Institutional Review Board ( IRB ) of Pusan National University Korean Hospital in September 2013 ( IRB approval number 2013012 ) .
BACKGROUND	The study findings will be published in peer-reviewed journals and presented at national and international conferences .
BACKGROUND	This trial was registered with the US National Institutes of Health Clinical Trials Registry : NCT01966250 .

###25683938
OBJECTIVE	Sorafenib , an oral multikinase inhibitor , is the proved therapy method for patients with advanced hepatocellular carcinoma ( HCC ) .
OBJECTIVE	Based on heat delivery , Radiofrequency ablation ( RFA ) has been found to achieve complete neoplasm necrosis .
OBJECTIVE	It is the most widely performed percutaneous therapy for HCC .
OBJECTIVE	However , Study associated combined Sorafenib with RFA therapy for patients with advanced HCC has never been reported .
OBJECTIVE	The aim of present study is to explore the efficacy and safety of sorafenib combined with RFA therapy for the patients with medium-sized HCC .
METHODS	A total of 62 patients diagnosed as HCC were involved in this study .
METHODS	All patients were randomly assigned to sorafenib and RFA ( n = 30 ) or RFA-alone ( n = 32 ) treatment groups .
METHODS	Treatment outcomes , including recurrence rates , time to progression ( TTP ) and adverse reactions induced by sorafenib were observed and recorded to assess the efficacy and safety of the combination method .
RESULTS	During the overall follow-up period , the recurrence rate of the combination subgroup was 56.7 % ( 17/30 ) , and that of the RFA-alone subgroup was 87.5 % ( 28/32 ) ( p < 0.01 ) .
RESULTS	The median TTP was 17.0 months in the combination therapy vs. 6.1 months in the RFA-alone ( p < 0.05 ) .
RESULTS	Hand-foot skin reactions were reported by 83.3 % ( 25/30 ) of patients and 46.7 % ( 14/30 ) reported diarrhea while the most adverse events ( AEs ) were mild to moderate in the combination subgroup .
CONCLUSIONS	Sorafenib combined with RFA significantly decreased recurrence rates and prolonged the survival time of medium-sized HCC patients .
CONCLUSIONS	The combination therapy is safer and more effective than the control without unexpected side effects .
CONCLUSIONS	Furthermore , the earlier application , the better results were .

###25724156
OBJECTIVE	To assess ibrutinib pharmacokinetics under fasted and fed conditions , impact of food-intake timing , and the safety and tolerability .
METHODS	Three studies were analyzed .
METHODS	Study 1 was a randomized , open-label , single-dose , four-way crossover study in 44 healthy participants .
METHODS	Study 2 was a randomized , repeat-dose crossover study in 16 patients with previously treated chronic lymphocytic leukemia ( CLL ) .
METHODS	Ibrutinib dose was 420mg in both studies .
METHODS	Study 3 was an open-label , sequential study to assess the effect of a standard breakfast on ibrutinib 560mg in eight healthy participants .
RESULTS	Administration of single-dose ibrutinib under fasting conditions ( study 1 ) resulted in approximately 60 % of exposure compared with drug intake either 30min before , 30min after ( fed ) , or 2h after a high-fat meal .
RESULTS	Similar food effect was observed ( study 3 ) when ibrutinib was given 30min before meal .
RESULTS	In CLL patients ( study 2 ) , the C max and AUC under fasting conditions were 43 and 61 % , respectively , relative to fed conditions .
RESULTS	When administered once-daily in uncontrolled food-intake conditions ( 30min before or 2h after ) , exposures were slightly ( 30 % ) lower than in fed condition .
RESULTS	When corrected for repeated dosing , pharmacokinetic parameters in healthy participants and patients were comparable .
RESULTS	Ibrutinib was generally well tolerated in all settings studied .
CONCLUSIONS	Ibrutinib administered in fasted condition reduces exposure to approximately 60 % as compared with dosing in proximity to food-intake , regardless of timing/type of meal .
CONCLUSIONS	Because repeated drug intake in fasted condition is unlikely , no food restrictions may be needed to administer ibrutinib .

###24815098
OBJECTIVE	We tested the effectiveness and feasibility of remote communication technologies to increase follow-up after early medical abortion .
METHODS	Women ( n = 999 ) were randomized to ` remote ' follow-up incorporating a low-sensitivity pregnancy test and standardized symptom questionnaire administered online , by text message or telephone by a non-clinical call center operator 2 weeks after treatment , or to ` clinic-based ' follow-up with ultrasound at 1 week .
METHODS	Women in the clinic-based group who could not return performed a high-sensitivity pregnancy test at 3 weeks and had a telephone call with clinic staff .
METHODS	The primary outcome was completion of follow-up .
METHODS	Rates of complications , acceptability and preferences were compared .
RESULTS	The overall follow-up rate did not differ by group { clinic-based , 73 % vs. remote , 69 % ; risk ratio ( RR ) 1.0 [ 95 % confidence interval ( CI ) 0.9-1 .2 ] } .
RESULTS	In the clinic-based group , 83 % did not return for an ultrasound scan and were followed up by phone .
RESULTS	In the remote group , follow-up by phone or text was more successful than online ( text : 75.4 % ; phone : 73.7 % ; online : 46.5 % , p < .001 ) .
RESULTS	The proportion of women receiving additional care was 9 % in the clinic-based group and was 4 % in the remote group [ RR 1.8 ( 95 % CI 1.1-3 .1 ) ] .
RESULTS	Most women found their follow-up method acceptable but would prefer follow-up by phone or text message if needed in future .
CONCLUSIONS	Follow-up after medical abortion using remote communication is feasible and , for most women , preferable to a clinic visit .
CONCLUSIONS	Medical abortion protocols typically use follow-up visits to ensure early identification of complications .
CONCLUSIONS	This study demonstrates that follow-up can be achieved using remote communication technologies .
CONCLUSIONS	This model may reduce the burden of multiple clinic visits on patients and providers .

###25364300
BACKGROUND	Carbohydrate-rich liquid drinks ( CRLDs ) have been recommended to attenuate insulin resistance by shortening the preoperative fasting interval .
BACKGROUND	The aim of our study the effect of preoperative oral administration of CRLDs on the well-being and clinical status of patients .
METHODS	A randomized , double blind , prospective study of patients undergoing open colorectal operations ( CR ) and open cholecyctectomy ( CH ) was conducted .
METHODS	Patients were divided into three groups : study , placebo , and control .
METHODS	Visual analogue scale ( VAS ) scores for seven parameters ( thirst , hunger , anxiety , mouth dryness , nausea , weakness and sleep quality ) were recorded and compared for two different time periods ( up to 24h postoperatively and from 36 to 48h postoperatively ) .
METHODS	The Simplified Acute Physiology Score changes ( SAPS ) - II between the three groups were also studied .
RESULTS	There were 142 patients American Society of Anesthesiology ( ASA ) I or II enrolled in the study ( CR = 71 and CH = 71 ) .
RESULTS	There were no significant differences in postoperative SAPS-II scores or lengths of hospital stay ( LOS ) between the groups .
RESULTS	However , in CR patients , the degree of thirst was partially improved by drinking CRLDs ( P = 0.027 ) .
RESULTS	In CH patients , on the other hand , feelings of thirst , hunger , mouth dryness , nausea and weakness showed significant improvement ( P < 0.05 ) .
CONCLUSIONS	Oral administration of carbohydrate-rich liquid drinks ( CRLDs ) improves the well-being in patients undergoing CH , but the effect is less evident in patients undergoing CR .
CONCLUSIONS	No significant improvements were seen in clinical status or in length of hospital stay in either group .
BACKGROUND	ANZCTR.org.au : ACTRN12614000995673 ( registered on 16/09/2014 ) .

###25582816
OBJECTIVE	To compare the acupuncture treatment and the medical treatment with antibiotics and nonsteroidal anti-inflammatory drugs ( NSAIDs ) on pain control , urinary symptoms , and quality of life of category IIIB chronic prostatitis-chronic pelvic pain syndrome ( CP-CPPS ) .
METHODS	From November 2008 to May 2009 , 54 male patients with category IIIB CP-CPPS were randomly divided into 2 groups : the medical treatment group ( group 1 , n = 28 ) and the acupuncture treatment group ( group 2 , n = 26 ) .
METHODS	Group 1 took levofloxacin 500 mg daily and ibuprofen 200 mg twice a day for 6 weeks .
METHODS	In the acupuncture group ( group 2 ) , bilateral BL32 ( Ciliao ) and BL33 ( Zhongliao ) acupoints were used to stimulate the sacral nerve using an electrical pulse generator , twice a week for 7 weeks .
METHODS	The change in National Institutes of Health Chronic Prostatitis Symptom Index scores from the baseline to the end of the treatment was observed .
RESULTS	The mean follow-up was 28 weeks from the baseline ( range , 20-43 weeks ) .
RESULTS	In acupuncture group , reduction of pain , urinary symptoms , quality of life , and total National Institutes of Health Chronic Prostatitis Symptom Index score was higher compared with the medical group .
CONCLUSIONS	However the treatment of CP-CPPS is challenging and difficult for the urologists .
CONCLUSIONS	This clinical study showed that the acupuncture treatment is a safe and effective treatment of category IIIB CP-CPPS .

###24488582
OBJECTIVE	To evaluate the treatment of simple endometrial hyperplasia without atypia with different gestagens .
METHODS	Sixty premenopausal women with histologically documented endometrial hyperplasia without atypia were included in this prospective controlled study .
METHODS	Patients were randomized into two groups : Group I included 30 patients who received lynestrenol ( LYN ) in a dose of 15 mg/d , while Group II included 30 patients who received micronized progesterone ( MP ) 200 mg/d for 12 days per cycle for 3 months .
METHODS	Patients were reevaluated with endometrial curettage after treatment .
METHODS	MP and LYN regimens were compared to regression , resolution or persistence rates and metabolic parameters .
RESULTS	After 3 months of treatment in both groups , none of the cases progressed .
RESULTS	In LYN group , the rate of resolution was observed to be higher compared to MP group ( p = 0.045 ) .
RESULTS	LYN was found more effective inducing resolution in patients more than 45 years compared to MP ( p = 0.036 ) .
RESULTS	When we compare both groups after 3 months of treatment , there was no statistically significant difference in BMI , total cholesterol , HDL , LDL and fibrinogen level between two groups .
RESULTS	The rate of patients without any side effects was found to be similar in both groups ( p = 0.5 ) .
CONCLUSIONS	LYN which is a synthetic progestin ensures better endometrial control compared to MP in simple hyperplasia without atypia in the patients of premenopausal age especially in ages more than 45 years .

###24691155
OBJECTIVE	The study used a randomized controlled trial to investigate the short-term and long-term effects of life-review as online-guided self-help in adults ( 40 + ) with moderate depressive symptomatology .
OBJECTIVE	We evaluated ego-integrity and rumination as mediators and assessed whether the effects of the intervention did not differ across middle-aged and older adults .
METHODS	Effects of life-review ( n = 58 ) were compared with a waiting list group ( n = 58 ) and an expressive writing intervention ( n = 58 ) on depressive symptoms ( primary outcome ) , anxiety , and well-being ( secondary outcomes ) .
METHODS	Mediator and moderator analyses were also applied .
RESULTS	Compared with the waiting list , life-review reduced depressive symptoms ( d = 0.35 ) and enhanced emotional ( d = 0.16 ) and psychological well-being ( d = 0.27 ) .
RESULTS	Life-review was not more effective than expressive writing .
RESULTS	The effects on depressive symptoms were partly related with increases in ego-integrity and decreases in rumination .
RESULTS	The intervention is applicable for middle-aged and older adults .
CONCLUSIONS	Life-review is effective as self-help for middle-aged and older adults with moderate depressive symptomatology compared with a waiting list group .
CONCLUSIONS	Future research should investigate whether stimulating ego-integrity and reducing rumination enhance the effects of the intervention .

###25145456
OBJECTIVE	The study aims to identify the association between the baseline retinal vascular calibre and visual outcome of patients with diabetic macular oedema ( DMO ) treated with intravitreal ranibizumab .
METHODS	The 1-M field ( as defined in the ETDRS study ) of the digital colour fundus photographs of DMO patients who had been treated primarily with ranibizumab in a clinical trial was assessed .
METHODS	Of the 84 patients , 25 had gradable retinal photographs that could be subjected to analyses by the Interactive Vessel Analysis ( IVAN ) software at baseline .
METHODS	The average retinal vascular calibre of the six largest venules ( CRVE ) and the six largest arterioles ( CRAE ) in the peripapillary area ( 0.5 and 1 disc diameter from the optic disc margin ) was measured .
METHODS	The relationship between CRVE and CRAE at baseline and the change in visual acuity at month 12 was assessed using the Mann-Whitney U test .
RESULTS	Ten eyes from 10 patients who had shown an improvement of 2 lines of best corrected visual acuity ( BCVA ) at month 12 had a wider baseline CRVE ( 248.324.5 m ) compared with the 15 eyes from 15 patients who did not show the improvement of 2 lines ( 226.644.8 m , P < 0.05 ) .
RESULTS	The baseline CRAE did not differ significantly in these patients ( 156.122.7 vs 14217.5 m , P = 0.17 ) .
CONCLUSIONS	A wider baseline retinal venular calibre may be a predictor of better visual outcome in DMO eyes treated with ranibizumab .
CONCLUSIONS	Further prospective studies with a larger sample size and a broader range of disease severity and visual acuity are needed to confirm this finding .

###24950841
BACKGROUND	Previous studies have shown that acupuncture can alleviate postmenopausal symptoms , such as hot flashes , but few studies have assessed symptoms during the menopausal transition ( MT ) period .
BACKGROUND	Thus , the effect of acupuncture upon MT symptoms is unclear .
BACKGROUND	We designed a large-scale trial aimed at evaluating the efficacy of electroacupuncture for MT symptoms compared with sham electroacupuncture and at observing the safety of electroacupuncture .
METHODS	In this multicenter randomized controlled trial , 360 women will be randomized to either an electroacupuncture group or a sham electroacupuncture group .
METHODS	During the 8-week-long treatment , a menopause rating scale , average 24-hour hot flash score , Menopause-Specific Quality of Life Questionnaire score , and level of female hormones will be observed .
METHODS	Follow-ups at the 20th and 32nd week will be made .
CONCLUSIONS	Though there is no completely inert placebo acupuncture and blinding is difficult in acupuncture trials , the placebo effect of EA can still be partially excluded in this study .
CONCLUSIONS	For the placebo control , we use non-points and a tailor-made sham needle .
CONCLUSIONS	This needle is different from a retractable needle , which is usually used for sham acupuncture .
CONCLUSIONS	The needle in this trial is more simply constructed and more acceptable to Chinese people .
CONCLUSIONS	We expect to evaluate the efficacy of electroacupuncture for MT symptoms and clarify its effect on these symptoms .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01849172 ( Date of registration : 05/05/2013 ) .

###24225233
BACKGROUND	Modest benefits from concurrent chemoradiotherapy in patients with locally advanced NSCLC warrant further clinical investigations to identify more effective treatment regimens .
BACKGROUND	Cetuximab , a monoclonal antibody against the epidermal growth factor receptor has shown activity in NSCLC .
BACKGROUND	We report on the safety and efficacy of the combination of daily dose Cisplatin and concurrent radiotherapy with or without weekly Cetuximab .
METHODS	Patients received high dose accelerated radiotherapy ( 66 Gy in 24 fractions ) and concurrent daily Cisplatin ( 6 mg/m ( 2 ) ) without ( Arm A ) or with ( Arm B ) weekly Cetuximab ( 400 mg/m ( 2 ) loading dose one week prior to radiotherapy followed by weekly 250 mg/m ( 2 ) ) .
METHODS	The primary endpoint of the trial was objective local control rate ( OLCR ) determined at 6-8 weeks after treatment .
METHODS	Toxicity was reported as well .
RESULTS	Between February 2009 and May 2011 , 102 patients were randomized .
RESULTS	Median follow up was 29 months .
RESULTS	The OLCR was 84 % in Arm A and 92 % in Arm B ( p = 0.36 ) .
RESULTS	The one-year local progression free interval ( LPFI ) and overall survival ( OS ) were 69 % and 82 % for Arm A and 73 % and 71 % for Arm B , respectively ( LPFI p = 0.39 ; OS p = 0.99 ) .
RESULTS	Toxicity compared equally between both groups .
CONCLUSIONS	The addition of Cetuximab to radiotherapy and concurrent Cisplatin did not improve disease control in patients with locally advanced NSCLC but increased treatment related toxicity .

###24952865
OBJECTIVE	Elevated cystatin C concentration is an independent risk factor for cardiovascular ( CV ) events in patients with acute coronary syndromes .
OBJECTIVE	Genetic polymorphisms in CST3 influence cystatin C levels , but their relationship to outcomes is unclear .
METHODS	We measured cystatin C concentrations in plasma , obtained within 24 hours of admission , in 16,279 acute coronary syndrome patients from the PLATO trial .
METHODS	In 9,978 patients , we performed a genome-wide association study with up to 2.5 million single nucleotide polymorphisms .
METHODS	Single nucleotide polymorphisms affecting cystatin C levels were evaluated in relation to the first occurrence of myocardial infarction ( MI ) or CV death within 1 year using Cox regression analysis .
RESULTS	Several single nucleotide polymorphisms were associated with cystatin C levels , most significantly rs6048952 ( P = 7.82 10 ( -16 ) ) adjacent to CST3 .
RESULTS	Median cystatin C concentrations per genotype were 0.85 mg/L ( A/A ) , 0.80 mg/L ( A/G ) , and 0.73 mg/L ( G/G ) .
RESULTS	Modeled as additive , the allelic effect , multivariable adjusted , was -0.045 mg/L per G allele for rs6048952 .
RESULTS	The multivariable adjusted c-statistic regarding the combined end point ( CV death or MI ) was 0.6735 .
RESULTS	Adding cystatin C or genotype-adjusted cystatin C levels resulted in c-statistics of 0.6761 and 0.6758 , respectively .
RESULTS	The multivariable adjusted hazard ratios per G allele at rs6048952 in the entire population were 0.94 ( 95 % CI 0.83-1 .06 ) for CV death or MI and 0.88 ( 95 % CI 0.71-1 .08 ) for CV death .
CONCLUSIONS	Genetic polymorphisms affect cystatin C concentrations independently of kidney function .
CONCLUSIONS	However , the polymorphisms were not observed to be associated with outcome , nor did they improve risk prediction or discriminative models .

###24956323
BACKGROUND	Given their high rates of uncontrolled blood pressure , urban African Americans comprise a particularly vulnerable subgroup of persons with hypertension .
BACKGROUND	Substantial evidence has demonstrated the important role of family and community support in improving patients ' management of a variety of chronic illnesses .
BACKGROUND	However , studies of multi-level interventions designed specifically to improve urban African American patients ' blood pressure self-management by simultaneously leveraging patient , family , and community strengths are lacking .
METHODS	We report the protocol of the Achieving Blood Pressure Control Together ( ACT ) study , a randomized controlled trial designed to study the effectiveness of interventions that engage patient , family , and community-level resources to facilitate urban African American hypertensive patients ' improved hypertension self-management and subsequent hypertension control .
METHODS	African American patients with uncontrolled hypertension receiving health care in an urban primary care clinic will be randomly assigned to receive 1 ) an educational intervention led by a community health worker alone , 2 ) the community health worker intervention plus a patient and family communication activation intervention , or 3 ) the community health worker intervention plus a problem-solving intervention .
METHODS	All participants enrolled in the study will receive and be trained to use a digital home blood pressure machine .
METHODS	The primary outcome of the randomized controlled trial will be patients ' blood pressure control at 12months .
CONCLUSIONS	Results from the ACT study will provide needed evidence on the effectiveness of comprehensive multi-level interventions to improve urban African American patients ' hypertension control .

###24788342
BACKGROUND	To have a better understanding of the mechanisms of exercise limitation in mild-to-moderate chronic obstructive pulmonary disease ( COPD ) , we compared detailed respiratory physiology in patients with COPD and healthy age - and sex-matched controls .
METHODS	Data were collected during the pre-treatment , patient characterization phase of a multicenter , randomized , double-blind , crossover study .
METHODS	Patients with COPD met Global Initiative for Chronic Obstructive Lung Disease ( GOLD ) 1 or 2 spirometric criteria , were symptomatic , and had evidence of gas trapping during exercise .
METHODS	All participants completed pulmonary function and symptom-limited incremental treadmill exercise tests .
RESULTS	Chronic activity-related dyspnea measured by Baseline Dyspnea Index was similarly increased in patients with GOLD 1 ( n = 41 ) and 2 ( n = 63 ) COPD compared with controls ( n = 104 ) .
RESULTS	Plethysmographic lung volumes were increased and lung diffusing capacity was decreased in both GOLD groups .
RESULTS	Peak oxygen uptake and work rate were reduced in both GOLD groups compared with controls ( p < 0.001 ) .
RESULTS	Submaximal ventilation , dyspnea , and leg discomfort ratings were higher for a given work rate in both GOLD groups compared with controls .
RESULTS	Resting inspiratory capacity , peak ventilation , and tidal volume were reduced in patients with GOLD 2 COPD compared with patients with GOLD 1 COPD and controls ( p < 0.001 ) .
CONCLUSIONS	Lower exercise tolerance in patients with GOLD 1 and 2 COPD compared with controls was explained by greater mechanical abnormalities , greater ventilatory requirements , and increased subjective discomfort .
CONCLUSIONS	Lower resting inspiratory capacity in patients with GOLD 2 COPD was associated with greater mechanical constraints and lower peak ventilation compared with patients with GOLD 1 COPD and controls .
BACKGROUND	ClinicalTrials.gov : NCT01072396 .

###24594090
BACKGROUND	Since their emergence from the operating theatre over a decade ago , supra-glottic airways ( SGA ) have become increasingly common in the management of out-of-hospital cardiac arrest ( OOHCA ) with laryngeal masks ( LM ) the most common SGA .
BACKGROUND	The proliferation of LMs in the prehospital setting has occurred despite lower than expected rates of successful insertion being reported .
METHODS	We conducted a single-centre , prospective parallel-group , ` open label ' randomised controlled trial in subjects with OOHCA ( aged greater than or equal to 12 years of age ; weighing greater than or equal to 30 kg ) were allocated to either the i-gel supraglottic airway ( IG-SGA ) or the Portex Soft Seal Laryngeal Mask ( PSS-LM ) within a large Australian ambulance service .
METHODS	Our hypothesis was that use of the IG-SGA , when compared to the Portex PSS-LM , would result in a higher rate of successful insertion in patients presenting with OOHCA .
METHODS	The primary outcome was successful insertion of the SGA .
RESULTS	There were 51 patients randomised .
RESULTS	Subjects had an average age of 65 years and 40 % were female .
RESULTS	There were no apparent differences in key demographic characteristics between groups .
RESULTS	The IG-SGA had a significantly higher success rate than the PSS-LM ( 90 % versus 57 % ; p = 0.023 ) , resulting in a 58 % greater likelihood of successful insertion than the PSS-LM ( RR 1.58 ; 95 % CI 1.11-2 .24 ) .
RESULTS	The IG-SGA was associated with significantly lower median `` ease of insertion '' scores .
CONCLUSIONS	The i-gel supraglottic airway was associated with higher successful insertion rates in subjects with out-of-hospital cardiac arrest .

###25419594
OBJECTIVE	Fat-soluble vitamin ( FSV ) deficiency is a well-recognized consequence of cholestatic liver disease and reduced intestinal intraluminal bile acid .
OBJECTIVE	We hypothesized that serum bile acid ( SBA ) would predict biochemical FSV deficiency better than serum total bilirubin ( TB ) level in infants with biliary atresia .
METHODS	Infants enrolled in the Trial of Corticosteroid Therapy in Infants with Biliary Atresia after hepatoportoenterostomy were the subjects of this investigation .
METHODS	Infants received standardized FSV supplementation and monitoring of TB , SBA , and vitamin levels at 1 , 3 , and 6 months .
METHODS	A logistic regression model was used with the binary indicator variable insufficient/sufficient as the outcome variable .
METHODS	Linear and nonparametric correlations were made between specific vitamin measurement levels and either TB or SBA .
RESULTS	The degree of correlation for any particular vitamin at a specific time point was higher with TB than with SBA ( higher for TB in 31 circumstances vs 3 circumstances for SBA ) .
RESULTS	Receiver operating characteristic curve shows that TB performed better than SBA ( area under the curve 0.998 vs 0.821 ) .
RESULTS	Including both TB and SBA did not perform better than TB alone ( area under the curve 0.998 ) .
CONCLUSIONS	We found that TB was a better predictor of FSV deficiency than SBA in infants with biliary atresia .
CONCLUSIONS	The role of SBA as a surrogate marker of FSV deficiency in other cholestatic liver diseases , such as progressive familial intrahepatic cholestasis , -1 - antitrypsin deficiency , and Alagille syndrome in which the pathophysiology is dominated by intrahepatic cholestasis , warrants further study .

###24344211
OBJECTIVE	High-dose interferon alfa-2b ( HDI ) has emerged as a potentially effective adjuvant therapy in patients with resected melanoma at high risk of recurrence .
OBJECTIVE	Evidence suggests it may be the early , very-high-dose part of the regimen that is critical .
OBJECTIVE	This pilot study sought to provide an early indication of whether the same effects can be achieved with the intravenous component of HDI alone and inform the feasibility and design of a phase III trial .
METHODS	Patients with stage 2B , 2C , 3B , and 3C melanoma were randomly assigned to receive interferon alfa-2b ( IFN -- 2b ) 20 MIU/m ( 2 ) intravenously ( IV ) daily 5 days per week for 4 weeks ( arm A ) versus the same regimen followed by IFN -- 2b 10 MIU/m ( 2 ) administered subcutaneously three times per week for 48 weeks ( arm B ) and observed for relapse-free survival ( RFS ) and overall survival .
RESULTS	Between 2003 and 2009 , 194 patients were enrolled ( arm A , 96 ; arm B , 98 ) .
RESULTS	After median follow-up of 39.5 months , RFS was 22.7 months ( 95 % CI , 14.1 to 38.1 months ) in arm A versus 33.3 months ( 95 % CI , 18.2 to not reached ) in arm B ( P = .28 ) .
RESULTS	The proportions of patients free of relapse at 2 years were 50 % and 54.1 % ( P = .569 ; hazard ratio , 0.89 ) , respectively .
RESULTS	Overall survival favored arm B ( median , 41.5 months v not reached ; P = .05 ) .
CONCLUSIONS	Clinical outcomes were better in patients who had the longer regimen .
CONCLUSIONS	Our results do not support either the use of a month of IV HDI alone in place of the year-long regimen or the initiation of a larger trial on this question .

###24549267
OBJECTIVE	To evaluate the role of the ultrasound contrast agent SonoVue in enhancing the ablation effects of ultrasound-guided high-intensity focused ultrasound ( HIFU ) on uterine fibroids .
METHODS	Eighty patients with solitary uterine fibroids at a single center were randomly assigned to a control or SonoVue group .
METHODS	Of these , 40 were treated using HIFU alone ; 40 who were pretreated with SonoVue received a bolus before the HIFU procedure .
METHODS	All patients underwent magnetic resonance imaging ( MRI ) scan before and after HIFU treatment .
RESULTS	The post-HIFU MRI showed the nonperfused volume ( NPV ) in all of the treated uterine fibroids ; the mean fractional ablation ( NPV ratio ) was 90.4 8.3 % ( range 66.4-100 % ) in the SonoVue group and 82.8 13.3 % ( range 53.4-100 % ) in the control group .
RESULTS	The frequency of massive gray-scale changes that occurred during HIFU was greater in the group that received SonoVue than the group that did not .
RESULTS	The average sonication time to reach massive gray-scale changes was significantly shorter in the group receiving SonoVue than the group without SonoVue .
RESULTS	The acoustic energy for treating 1 mm ( 3 ) of uterine fibroid was less in the SonoVue group than the control group .
RESULTS	No any major complication occurred in this study .
CONCLUSIONS	Based on the results of this randomized controlled trial , SonoVue could be safely used to enhance the effects of HIFU treatment for uterine fibroids .

###25809682
BACKGROUND	Few data exist on the ability of postmenopausal women to absorb calcium from diets habitually low in calcium .
OBJECTIVE	The objective of this study was to evaluate fractional calcium absorption from a green leafy vegetable vs. milk in relation to vitamin D status .
METHODS	We measured fractional calcium absorption from both a dairy - and plant-based source in 19 postmenopausal Thai women ( aged 52-63 y ) with low calcium consumption ( 350 207 mg/d ) in relation to serum parathyroid hormone ( PTH ) and serum 25-hydroxyvitamin D [ 25 ( OH ) D ] .
METHODS	Fractional calcium absorption was measured using a triple stable calcium isotope method based on isotope recovery in a 28-h urine collection .
METHODS	Two extrinsically labeled test meals were ingested in random order : a green leafy vegetable ( cassia ) ingested along with Ca or a glass of milk containing Ca .
METHODS	Women received intravenous Ca with the first test meal .
RESULTS	In 19 postmenopausal women studied ( mean age , 56.9 3.4 y ) , ~ 95 % were 25 ( OH ) D sufficient ( 20 g/L ) .
RESULTS	Serum 25 ( OH ) D status was positively correlated with fractional absorption from both cassia ( P = 0.05 , R = 0.21 ) and milk ( P = 0.03 , R = 0.26 ) .
RESULTS	Fractional calcium absorption from cassia was significantly lower than that measured from milk ( 42.6 % 12.3 % vs. 47.8 % 12.8 % , P = 0.03 ) , but true calcium absorption did not significantly differ ( 120 35 mg/d vs. 135 36 mg/d ) .
RESULTS	Serum PTH was significantly inversely associated with serum 25 ( OH ) D ( P = 0.006 , R = 0.37 ) even though PTH was not elevated ( > 65 pg/mL ) .
CONCLUSIONS	These findings suggest that vitamin D status is an important determinant of calcium absorption among Thai women with low calcium intakes , and cassia may be a readily available source of calcium in this population .
CONCLUSIONS	Furthermore , these data indicate that serum 25 ( OH ) D concentrations may affect PTH elevation in postmenopausal women with low calcium intakes .

###24929799
BACKGROUND	The PHARMACOP-intervention significantly improved medication adherence and inhalation technique for patients with COPD compared with usual care .
BACKGROUND	This study aimed to evaluate its cost-effectiveness .
METHODS	An economic analysis was performed from the Belgian healthcare payer 's perspective .
METHODS	A Markov model was constructed in which a representative group of patients with COPD ( mean age of 70years , 66 % male , 43 % current smokers and mean Forced Expiratory Volume in 1second of % predicted of 50 ) , was followed for either receiving the 3-month PHARMACOP-intervention or usual care .
METHODS	Three types of costs were calculated : intervention costs , medication costs and exacerbation costs .
METHODS	Outcome measures included the number of hospital-treated exacerbations , cost per prevented hospital-treated exacerbation and cost per Quality Adjusted Life-Year .
METHODS	Follow-up was 1year in the basecase analysis .
METHODS	Sensitivity and scenario analyses ( including long-term follow-up ) were performed to assess uncertainty .
RESULTS	In the basecase analysis , the average overall costs per patient for the PHARMACOP-intervention and usual care were 2,221 and 2,448 , respectively within the 1-year time horizon .
RESULTS	This reflects cost savings of 227 for the PHARMACOP-intervention .
RESULTS	The PHARMACOP-intervention resulted in the prevention of 0.07 hospital-treated exacerbations per patient ( 0.177 for PHARMACOP versus 0.244 for usual care ) .
RESULTS	Results showed robust cost-savings in various sensitivity analyses .
CONCLUSIONS	Optimization of current pharmacotherapy ( e.g. close monitoring of inhalation technique and medication adherence ) has been shown to be cost-saving and should be considered before adding new therapies .

###25504427
OBJECTIVE	To compare pain , projected breast area , radiation dose and image quality between flexible ( FP ) and rigid ( RP ) breast compression paddles .
METHODS	The study was conducted in a Dutch mammographic screening unit ( 288 women ) .
METHODS	To compare both paddles one additional image with RP was made , consisting of either a mediolateral-oblique ( MLO ) or craniocaudal-view ( CC ) .
METHODS	Pain experience was scored using the Numeric Rating Scale ( NRS ) .
METHODS	Projected breast area was estimated using computer software .
METHODS	Radiation dose was estimated using the model by Dance .
METHODS	Image quality was reviewed by three radiologists and three radiographers .
RESULTS	There was no difference in pain experience between both paddles ( mean difference NRS : 0.080.08 , p = 0.32 ) .
RESULTS	Mean radiation dose was 4.5 % lower with FP ( 0.090.01 p = 0.00 ) .
RESULTS	On MLO-images , the projected breast area was 0.79 % larger with FP .
RESULTS	Paired evaluation of image quality indicated that FP removed fibroglandular tissue from the image area and reduced contrast in the clinically relevant retroglandular area at chest wall side .
CONCLUSIONS	Although FP performed slightly better in the projected breast area , it moved breast tissue from the image area at chest wall side .
CONCLUSIONS	RP showed better contrast , especially in the retroglandular area .
CONCLUSIONS	We therefore recommend the use of RP for standard MLO and CC views .

###24460811
OBJECTIVE	To determine changes in respiratory mechanics when chest compressions are added to mask ventilation , as recommended by the International Liaison Committee on Resuscitation ( ILCOR ) guidelines for newborn infants .
METHODS	Using a Laerdal Advanced Life Support leak-free baby manikin and a 240-mL self-inflating bag , 58 neonatal staff members were randomly paired to provide mask ventilation , followed by mask ventilation with chest compressions with a 1:3 ratio , for two minutes each .
METHODS	A Florian respiratory function monitor was used to measure respiratory mechanics , including mask leak .
RESULTS	The addition of chest compressions to mask ventilation led to a significant reduction in inflation rate , from 63.9 to 32.9 breaths per minute ( p < 0.0001 ) , mean airway pressure reduced from 7.6 to 4.9 cm H2 O ( p < 0.001 ) , minute ventilation reduced from 770 to 451 mL/kg/min ( p < 0.0001 ) , and there was a significant increase in paired mask leak of 6.8 % ( p < 0.0001 ) .
CONCLUSIONS	Adding chest compressions to mask ventilation , in accordance with the ILCOR guidelines , in a manikin model is associated with a significant reduction in delivered ventilation and increase in mask leak .
CONCLUSIONS	If similar findings occur in human infants needing an escalation in resuscitation , there is a potential risk of either delay in recovery or inadequate response to resuscitation .

###25315287
BACKGROUND	We describe the design of the MERGE trial , a cluster randomised trial , to evaluate the effect of an intervention to optimise TB/HIV service integration on mortality , morbidity and retention in care among newly-diagnosed HIV-positive patients and newly-diagnosed TB patients .
METHODS	Eighteen primary care clinics were randomised to either intervention or standard of care arms .
METHODS	The intervention comprised activities designed to optimise TB and HIV service integration and supported by two new staff cadres-a TB/HIV integration officer and a TB screening officer-for 24 months .
METHODS	A process evaluation to understand how the intervention was perceived and implemented at the clinics was conducted as part of the trial .
METHODS	Newly-diagnosed HIV-positive patients and newly-diagnosed TB patients were enrolled into the study and followed up through telephonic interviews and case note abstractions at six monthly intervals for up to 18 months in order to measure outcomes .
METHODS	The primary outcomes were incidence of hospitalisations or death among newly diagnosed TB patients , incidence of hospitalisation or death among newly diagnosed HIV-positive patients and retention in care among HIV-positive TB patients .
METHODS	Secondary outcomes of the study included measures of cost-effectiveness .
CONCLUSIONS	Methodological challenges of the trial such as implementation of a complex multi-faceted health systems intervention , the measurement of integration at baseline and at the end of the study and an evolving standard of care with respect to TB and HIV are discussed .
CONCLUSIONS	The trial will contribute to understanding whether TB/HIV service integration affects patient outcomes .

###25095846
OBJECTIVE	The level of mutans streptococci ( MS ) is reduced by regularly consumption of probiotic Kefir drink .
OBJECTIVE	The present study aiming at answer to this question ` may the Kefir drink be considered an alternative to fluoride rinse ? '
METHODS	Twenty-two healthy volunteers aged 22-32 years with good oral hygiene participated in this study .
METHODS	None of participants had received any antibiotic or antimicrobial agent or professional fluoride therapy within the last month .
METHODS	None of them exhibited active caries lesions .
METHODS	Smokers and subjects who have chewing gums xylitol habit or who were undergoing orthodontic treatment were excluded .
METHODS	In a cross over design with 2 parallel groups , people in group A for 2 weeks received 100 ml of Kefir drink per day , then avoided brushing , eating and drinking for an hour .
METHODS	Simultaneously , people in group B were administered 0.05 % sodium fluoride rinse in the same manner .
METHODS	After washout period , people in groups A and B respectively used 0.05 % sodium fluoride rinse and Kefir drink .
METHODS	Saliva sampling was performed before and after interventions .
METHODS	The acidity and the count of MS were assessed and data were analyzed statistically .
RESULTS	There was no significant difference between base line pH values of saliva in study groups ( p > 0.05 ) .
RESULTS	Although , a significant difference was shown between MS counts before and after interventions ( p 0.0001 and p 0.0001 for NaF and Kefir respectively ) , but the equal inhibitory effect was found between study groups ( p > 0.05 ) .
CONCLUSIONS	Kefir drink can inhibit salivary MS as well the sodium fluoride rinse .
CONCLUSIONS	This beverage may be considered an alternative for fluoride rinse .
CONCLUSIONS	Clinical significance : Probiotics containing dairy products was known with anticariogenic properties .
CONCLUSIONS	These agents may be used in caries control strategies adjunctively .

###25022106
OBJECTIVE	To compare the therapeutic differences among scalp acupuncture combined with auricular point sticking , body acupuncture and western medication for treatment of vascular dementia ( VD ) .
METHODS	Ninety cases were randomly divided into a combined therapy group ( 31 cases ) , a body acupuncture group ( 29 cases ) and a western medication group ( 30 cases ) .
METHODS	The combined therapy group was treated with scalp acupuncture at forehead middle line , parieral middle line , temporal front line and temporal rear line as well as auricular point sticking at naogan ( AT3 ,41 ) , shen ( CO10 ) , shenmen ( TF4 ) , zhen ( AT3 ) , once a day ; the body acupuncture group was treated with acupuncture at Baihui ( GV 20 ) , Fengchi ( GB 20 ) , Zusanli ( ST 36 ) and so on , once a day ; the western medication group was treated with oral administration of aniracetam tablets , 0.2 g per time , twice a day .
METHODS	Fourteen days were considered as a treatment course , and totally 3 courses were required .
METHODS	The mini-mental state examination ( MMSE ) and activities of daily living ( ADL ) were applied to assess the changes of cognitive behavior ability before and after treatment among three groups .
METHODS	Also the efficacy among three groups were compared .
RESULTS	One case dropped out in the body acupuncture group and western medication group , respectively .
RESULTS	The total effective rate was 90.334 ( 28/31 ) in the combined therapy group , which was superior to 85.734 ( 24/28 ) in the body acupuncture group and 79.3 % ( 23/29 ) in the western medication group ( both P < 0.05 ) .
RESULTS	After the treatment , the scores of MMSE and ADL were all improved among three groups , which was the most significant in the combined therapy group ( MMSE : 23.32 + / - 4.45 vs 21.23 + / - 4.13 , P < 0.05 ; 23.32 + / - 4.45 vs 20.41 + / - 4.01 , P < 0.01 ; ADL : 53.18 + / - 21.55 vs 51.92 + / - 20.42 , P < 0.05 ; 53.18 + / - 21.55 vs 49.42 + / - 19.43 , P < 0.01 ) .
CONCLUSIONS	The scalp acupuncture combined with auricular point sticking could improve the clinical symptoms and cognitive behavior ability in patients with vascular dementia , which has superior total efficacy to body acupuncture and western medication aniracetam tablets .

###24621109
BACKGROUND	The study evaluated the efficacy of beclomethasone dipropionate/formoterol fumarate ( BDP/FF ) extrafine combination versus fluticasone propionate/salmeterol ( FP/S ) combination in COPD patients .
METHODS	The trial was a 12-week multicentre , randomised , double-blind , double dummy study ; 419 patients with moderate/severe COPD were randomised to BDP/FF 200/12 g or FP/S 500/50 g twice daily .
METHODS	The primary objective was to demonstrate the equivalence between treatments in terms of Transition Dyspnoea Index ( TDI ) score and the superiority of BDP/FF in terms of change from pre-dose in the first 30 minutes in forced expiratory volume in the first second ( FEV1 ) .
METHODS	Secondary endpoints included lung function , symptom scores , symptom-free days and use of rescue medication , St. George 's Respiratory Questionnaire , six minute walking test and COPD exacerbations .
RESULTS	BDP/FF was equivalent to FP/S in terms of TDI score and superior in terms of FEV1 change from pre-dose ( p < 0.001 ) .
RESULTS	There were no significant differences between treatments in secondary outcome measures , confirming overall comparability in terms of efficacy and tolerability .
RESULTS	Moreover , a clinically relevant improvement ( > 4 units ) in SGRQ was detected in the BDP/FF group only .
CONCLUSIONS	BDP/FF extrafine combination provides COPD patients with an equivalent improvement of dyspnoea and a faster bronchodilation in comparison to FP/S .
BACKGROUND	ClinicalTrials.gov : NCT01245569 .

###24556626
BACKGROUND	The main objective of the present study was to establish the relationships between CA-125 kinetics and tumour size changes during treatment .
METHODS	The data from the CALYPSO-randomised phase III trial , comparing two platinum-based regimens in recurrent ovarian cancer ( ROC ) patients , was randomly split into a ` learning data set ' to estimate model parameters and a ` validation data set ' to validate model performances .
METHODS	A kinetic-pharmacodynamic semi-mechanistic model was built to describe tumour size and CA-125 kinetics during chemotherapy .
METHODS	The ability of the model to predict tumour response induced by chemotherapy , based on CA-125 values , was assessed .
RESULTS	Data from 535 ROC patients were used to model CA-125 kinetics and tumour size changes during the first 513 days after treatment initiation .
RESULTS	Using the validated model , we could predict with accuracy the tumour size changes induced by chemotherapy based on the baseline imaging assessment and longitudinal CA-125 values ( mean prediction error : 0.3 % , mean absolute prediction error : 10.6 % ) .
CONCLUSIONS	Using a semi-mechanistic model , the dynamic relationships between tumour size changes and CA-125 kinetics induced by chemotherapy were established in ROC patients .
CONCLUSIONS	A modelling approach allowed CA-125 to be assessed as a biomarker for tumour size dynamics , to predict treatment efficacy for research and clinical purposes .

###24621025
OBJECTIVE	To investigate the analgesic effect of repetitive transcranial magnetic stimulation ( rTMS ) on intractable neuropathic pain in patients with spinal cord injury ( SCI ) .
METHODS	A single center , prospective , randomized , double-blinded , controlled study .
METHODS	SCI rehabilitation unit of university rehabilitation center .
METHODS	Seventeen patients with SCI and chronic neuropathic pain who met the inclusion criteria recruited between April 2010 and January 2012 .
METHODS	Ten daily treatment sessions of real or sham rTMS ( 30 trains of 10-Hz stimuli for a duration of 5 seconds ; a total of 1500 pulses at intensity equal to 110 % of the resting motor threshold ) was applied over vertex using a gure-of-8-shaped coil .
METHODS	Pain was assessed with visual analog scale ( VAS ) at baseline and 10 days , 6 weeks and 6 months after the treatment .
METHODS	Patients ' satisfactions obtained using a 5-point Likert scale at 6 months .
RESULTS	Both real and sham rTMS provided a significant reduction in the VAS scores ( real rTMS group , P = 0.004 ; sham rTMS group , P = 0.020 ) .
RESULTS	Post hoc analysis revealed the significant difference was at 10 days and 6 weeks compared to baseline in the real rTMS group and only at 10 days compared to baseline in the sham rTMS group .
RESULTS	Comparison of VAS scores and patient satisfaction did not show any significant difference at each assessment point ( P > 0.05 ) .
CONCLUSIONS	Our results demonstrated analgesic effect of rTMS on intractable neuropathic pain in SCI was not superior to placebo .
CONCLUSIONS	However , middle-term ( over 6 weeks ) pain relief by rTMS is encouraging and suggests the need for future studies with a larger sample size .

###25368252
BACKGROUND	Lymphocytes and natural killer cells ( NK ) appear to be important in colorectal cancer .
BACKGROUND	Their role in chemoradiotherapy for rectal cancers is unclear .
BACKGROUND	We evaluated T-lymphocytes ( CD3 ) , sub-groups CD4 and CD8 , and NK cells ( CD56 + CD57 ) in normal and rectal tumor tissues pre - and post-chemoradiotherapy , and investigated their relationship to tumor regression grade , disease-free survival and pathological stage .
METHODS	Tissue microarrays from colonoscopic biopsies , resection specimens and normal tissues , from 52 patients , were immunostained .
RESULTS	NK cell counts were significantly lower in tumor samples compared to normal tissues ( p = 0.007 ) .
RESULTS	T-lymphocyte counts were higher in post-treatment compared to pre-treatment samples ( p = 0.025 ) , specifically in the CD8 subgroup after long-course treatment .
RESULTS	The results suggested an association between post-treatment CD8 and NK cell counts with higher tumor regression .
RESULTS	No associations were found with regard to stage or disease-free survival .
CONCLUSIONS	NK cell counts were significantly reduced in rectal cancers compared to normal tissues , while total T-lymphocyte counts increased post-chemoradiotherapy .
CONCLUSIONS	Both appeared important in tumor regression .

###24843955
OBJECTIVE	To observe the impacts on skeletal fluorosis pain , joint motor dysfunction and urine fluoride excretion in the treatment with fire needle therapy , electroacupuncture and calcium carbonate D3 .
METHODS	The randomized controlled trial was adopted .
METHODS	Ninety-five patients were randomized into a fire needle group ( 31 cases ) , an electroacupuncture group ( 33 cases ) and a calcium carbonate D3 group ( 31 cases ) .
METHODS	In the fire needle group and the electroacupuncture group , Ashi points , Dazhui ( GV 14 ) , Geshu ( BL 17 ) , Quchi ( LI 11 ) , Hegu ( LI 4 ) , Xuehai ( SP 10 ) points were selected and stimulated with fire needle and electroacupuncture separately , three times a week .
METHODS	In the calcium carbonate D3 group , calcium carbonate D3 tablets was prescribed for oral administration , 600 mg each time , twice a day .
METHODS	The duration of treatment was 2 months in the electroacupuncture group and calcium carbonate D3 group and 1 month in the fire needle group .
METHODS	VAS score , the range of motion ( ROM ) and urine fluoride value were compared before and after treatment in the patients of the three groups .
RESULTS	After treatment , VAS value and ROM were improved significantly in the patients of the three groups ( all P < 0.05 ) , the difference was not significant in comparison of the three groups ( all P > 0.05 ) .
RESULTS	After treatment , the urine fluoride value was increased significantly in the fire needle group [ ( 7.89 + / - 3.61 ) mg/L vs ( 9.81 + / - 4.17 ) mg/L , P < 0.01 ] and was increased in the electroacupuncture group [ ( 7.53 + / - 3.46 ) mg/L vs ( 8.97 + / - 4.21 ) mg/L , P < 0.05 ] .
RESULTS	The difference was not significant in comparison before and after treatment in the calcium carbonate D3 group ( P > 0.05 ) .
CONCLUSIONS	The fire needle therapy , electroacupuncture and calcium carbonate D3 all have the clinical value in the prevention and treatment of skeletal fluorosis and the difference in the therapeutic effect has not been discovered among them yet at present .
CONCLUSIONS	But it has been found that the fire needle therapy and electroacupuncture display the active significance in the promotion of urine fluoride excretion .

###24325051
OBJECTIVE	To observe the effect of Wenxin Granule ( WG ) on brain natriuretic peptide ( BNP ) and heart rate variability ( HRV ) of acute coronary syndrome ( ACS ) patients .
METHODS	Totally 65 ACS patients were randomly assigned to the treatment group ( 35 cases ) and the control group ( 30 cases ) .
METHODS	All patients were treated with routine therapies such as angiotensin conversing enzyme inhibitors ( ACEI ) and metoprolol .
METHODS	Those in the treatment group took WG , 9 g each time , three times daily .
METHODS	All were treated for 90 days .
METHODS	Plasma samples of BNP and HRV were determined before treatment and after treatment .
RESULTS	There was no statistical difference in pre-treatment plasma BNP ( P > 0.05 ) .
RESULTS	Plasma BNP significantly decreased after treatment in the two groups when compared with before treatment ( P < 0.05 ) .
RESULTS	The decrease was more obvious in the treatment group ( P < 0.05 ) .
RESULTS	There was no statistical difference in pre-treatment HRV ( P > 0.05 ) .
RESULTS	Compared with before treatment in the same group , RMSSD , PNN50 % , and high frequency ( HF ) obviously increased , while low frequency ( LF ) and LF/HF ratio significantly decreased in the two groups , showing statistical difference ( P < 0.05 ) .
RESULTS	The aforesaid indices were obviously better in the treatment group than in the control group ( P < 0.05 ) .
CONCLUSIONS	Additional administration of WG could improve short-term clinical prognosis by down-regulating plasma BNP level ( via improving myocardial ischemia ) and modulating HRV .

###25863753
OBJECTIVE	To determine , in the setting of advanced-stage of Hodgkin lymphoma ( HL ) , whether relapses occur in the irradiated planning target volume and whether the definition of local radiation therapy ( RT ) used by the German Hodgkin Study Group ( GHSG ) is adequate , because there is no harmonization of field and volume definitions among the large cooperative groups in the treatment of advanced-stage HL .
METHODS	All patients with residual disease of 2.5 cm after multiagent chemotherapy ( CTX ) were evaluated using additional positron emission tomography ( PET ) , and those with a PET-positive result were irradiated with 30 Gy to the site of residual disease .
METHODS	We re-evaluated all sites of disease before and after CTX , as well as the PET-positive residual tumor that was treated in all relapsed patients .
METHODS	Documentation of radiation therapy ( RT ) , treatment planning procedures , and portal images were carefully analyzed and compared with the centrally recommended RT prescription .
METHODS	The irradiated sites were compared with sites of relapse using follow-up computed tomography scans .
RESULTS	A total of 2126 patients were enrolled , and 225 patients ( 11 % ) received RT. .
RESULTS	Radiation therapy documents of 152 irradiated patients ( 68 % ) were analyzed , with 28 irradiated patients ( 11 % ) relapsing subsequently .
RESULTS	Eleven patients ( 39 % ) had an in-field relapse , 7 patients ( 25 % ) relapsed outside the irradiated volume , and an additional 10 patients ( 36 % ) showed mixed in - and out-field relapses .
RESULTS	Of 123 patients , 20 ( 16 % ) with adequately performed RT relapsed , compared with 7 of 29 patients ( 24 % ) with inadequate RT. .
CONCLUSIONS	The frequency and pattern of relapses suggest that local RT to PET-positive residual disease is sufficient for patients in advanced-stage HL .
CONCLUSIONS	Insufficient safety margins of local RT may contribute to in-field relapses .

###26161609
OBJECTIVE	The purpose of this study was to investigate the remineralization activation of the application of three fissure sealants ( FSs ) , alone or with gaseous ozone ( GO ) , on non-cavitated initial caries and evaluate the clinical success of FS .
METHODS	Sixty children who had DIAGNOdent scores between 10-30 on bilateral symmetric mandibular first permanent molars were included in study .
METHODS	In a split-mouth design , teeth were assigned to experimental ( with GO ) and control ( without GO ) groups .
METHODS	GO was applied to teeth on one side and then the same brand of randomly selected FSs was applied to the teeth on both sides .
METHODS	Children were divided into 3 groups based on type of FS ( Group 1 : Aegis { Bosworth Co , North Hamlin Avenue Skokie , Illinois , USA } , Group 2 : Fuji Triage { GC , Tokyo , Japan } , Group 3 : Helioseal { Ivoclar Vivadent , Liechtenstein , Germany } ) .
METHODS	All FSs were then examined for retention rates at 1 , 3 , 6 , 9 , and 12 months ; at the end of 12 months , all FSs were removed with an air-abrasion device and DIAGNOdent scores noted to compare with the initial values .
RESULTS	The application of GO with either Fuji Triage or Aegis FS was effective on remineralization ( p < 0.05 ) ; however , the application of Helioseal FSs was not effective ( p > 0.05 ) .
RESULTS	The 1 ( st ) and 12 ( th ) months ' full retention rates of Fuji Triage FSs was a significant difference ( p < 0.05 ) from other FSs ( Aegis and Helioseal ) ( p > 0.05 ) .
CONCLUSIONS	GO+A egis FS showed the highest remineralization ; and , at the end of 12 months , its clinical success was higher than other FSs .

###25136791
OBJECTIVE	We wish to assess the clinical and cost-effectiveness of remote monitoring of heart failure patients with cardiac implanted electronic devices .
METHODS	REM-HF is a multicentre , randomized , non-blinded , parallel trial designed to compare weekly remote monitoring-driven management with usual care for patients with cardiac implanted electronic devices ( ICD , CRT-D , or CRT-P ) .
METHODS	The trial is event driven , and the final analysis will be performed when 546 events have been observed or the study is terminated at the interim analysis .
METHODS	We have randomized 1650 patients to be followed up for a minimum of 2 years .
METHODS	Patients will remain in the trial up to study termination .
METHODS	The first patient was randomized in September 2011 and the study is expected to complete in early 2016 .
METHODS	The primary combined endpoint is time to first event of all-cause death or unplanned hospitalization for cardiovascular reasons .
METHODS	An economic evaluation will be performed , estimating the cost per quality-adjusted life year , with direct costs estimated from the National Health Service perspective and quality of life assessed by the EQ-5D , Short-Form 12 , and Kansas City Cardiomyopathy Questionnaires .
METHODS	The study design has been informed by a feasibility study .
CONCLUSIONS	REM-HF is a multicentre randomized study that will provide important data on the effect of remote monitoring-driven management of implanted cardiac devices on morbidity and mortality , as well as the cost-effectiveness of this approach .

###24469903
BACKGROUND	We have previously shown that short sessions of whole body vibration ( WBV ) were not able to significantly improve fall risk among nursing home residents but some trends towards an improvement of motor capacity were observed .
OBJECTIVE	The objective of the present study was to evaluate the impact of 6-month training by WBV on functional and motor abilities among nursing home residents observed over a 12-month period .
METHODS	Patients were randomized into two groups : the WBV group which received three training sessions every week composed of five series of 15 s of vibration at 30 Hz intensity for a period of 6 months and a control group with normal daily life .
METHODS	The impact of this training on the risk of falls was assessed blindly after 6 and 12 months by the Tinetti Test , the `` Timed Up and Go '' test and a quantitative evaluation of a 10-s walk performed with a tri-axial accelerometer .
METHODS	The occurrence of falls was also observed .
RESULTS	62 elderly healthy volunteers , ( 47 women and 15 men , mean age 83.2 7.9 years ) were included in this study .
RESULTS	There was no significant difference between the two groups regarding the Tinetti test ( p = 0.75 ) , the `` Timed Up and Go '' test ( p = 0.19 ) and the Locomtrix ( ) test , except for the step length , measured by dual task ( p < 0.01 ) .
RESULTS	No significant inter-group difference in the frequency of falls was observed during the 12 months of research .
RESULTS	A total of 42 falls were recorded during the first 6 months of experimentation : 24 falls in the treated group and 18 in the control group ( p = 0.60 ) .
RESULTS	During the next 6 months , 19 falls occurred : 8 falls in the treated group and 11 in the control group ( p = 0.52 ) .
CONCLUSIONS	This study failed to establish the effectiveness of low doses of WBV , under the conditions used in our study , on functional and motor abilities of institutionalized elderly patients .
CONCLUSIONS	However , given the positive results of other studies , further investigations , with modified therapeutic protocols , seem necessary to clarify the effects of WBV in the elderly .

###24709034
OBJECTIVE	To determine the efficacy and safety of 2 doses of botulinum toxin type B ( rimabotulinumtoxinB , BoNT/B ) in spastic upper limb muscles .
METHODS	Randomized , double-blind , placebo-controlled trial with a 3-month follow-up .
METHODS	Tertiary care center .
METHODS	Referred sample of adult hemiparetic patients ( N = 24 ) with disabling elbow flexor overactivity after stroke or traumatic brain injury .
METHODS	Injection of 10,000 U of rimabotulinumtoxinB ( fixed 2500U dose into elbow flexors ; n = 8 ) , 15,000 U ( 5000U into elbow flexors ; n = 8 ) , or placebo ( n = 8 ) into overactive upper limb muscles selected as per investigator 's discretion .
METHODS	At 1 month postinjection , active range of elbow extension ( goniometry ; primary outcome ) ; active upper limb function ( Modified Frenchay Scale [ MFS ] ) ; subjective global self-assessment ( GSA ) of arm pain , stiffness , and function ; rapid alternating elbow flexion-extension movement frequency over the maximal range ; elbow flexor spasticity grade and angle ( Tardieu ) , and tone ( Ashworth ) .
RESULTS	No adverse effects were associated with either BoNT/B dose .
RESULTS	Both doses improved active elbow extension versus placebo ( +8.3 ; 95 % confidence interval , 1.1-15 .5 ; analysis of covariance , P = .028 ) .
RESULTS	The high dose of BoNT/B also improved subject-perceived stiffness ( P = .005 ) and the composite pain , stiffness , and function GSA ( P = .017 ) , effects that persisted 3 months from injection .
RESULTS	No MFS change was demonstrated , although subjects with a baseline MFS < 70/100 seemed more likely to benefit from BoNT/B .
CONCLUSIONS	In this short-term study , BoNT/B up to 15,000 U into spastic upper limb muscles , including the elbow flexors , was well tolerated and improved active elbow extension and subject-perceived stiffness .

###25856740
BACKGROUND	Posttraumatic stress disorder ( PTSD ) symptoms in individuals who have experienced repeated trauma ( sexual and/or physical ) in early childhood can lead to problems associated with emotion regulation , interpersonal functioning and self-image .
BACKGROUND	This so-called complex PTSD is often accompanied by a comorbid personality disorder .
BACKGROUND	Although ptsd is associated with structural and functional abnormalities in emotion-regulation areas in the brain , it is not known whether complex PTSD shows similar abnormalities .
BACKGROUND	Experts take the view that before individuals with complex PTSD are given appropriate therapy they should receive a course of emotion-regulation therapy such as the one tested by Zlotnick e.a. ( 1997 ) in a randomised controlled trial ( RCT ) .
OBJECTIVE	To replicate Zlotnick 's RCT in the Netherlands and to find out whether complex PTSD patients show specific structural and functional brain abnormalities and whether psychological recovery is linked to the ` normalisation ' of these abnormalities .
METHODS	In a RCT with complex PTSD patients ( n = 71 ) who had experienced trauma in early childhood , we compared normal individual treatment with treatment supported by ` Before and beyond ' , which consists of emotion-regulation therapy combined with cognitive group therapy .
METHODS	In a subsample ( n = 33 ) we also performed an mri ( repeated , n = 9 ) in which individuals were required to execute an emotional memory and attention task .
RESULTS	In complex PTSD , structural abnormalities in the brain seemed to be more extensive than in PTSD and brain activity in complex PTSD seemed to be strikingly different from the brain activity seen in PTSD patients who had experienced only single trauma .
RESULTS	The results of the RCT indicate that ` Before and beyond ' is a clinically meaningful treatment ( with minimal drop-out ) for complex PTSD patients with a variety of personality disorders .
RESULTS	The psychological recovery of patients who received the emotion regulation and cognitive group treatment was associated with normalisation of brain function .
CONCLUSIONS	Treatment guidelines for ptsd patients can not be applied directly and automatically to complex PTSD because there is no scientific evidence to justify such a step .
CONCLUSIONS	The neurobiological profile of PTSD differs from that of complex PTSD .
CONCLUSIONS	Patients with complex PTSD seem to react favourably to emotion regulation therapy .
CONCLUSIONS	This treatment therefore could be a useful addition to the current PTSD guideline for this specific group .
CONCLUSIONS	There is a need for further research that focuses on complex PTSD patients .

###25366542
BACKGROUND	Young children 's diets are currently suboptimal .
BACKGROUND	Given that mothers have a critical influence on children ' diets , they are typically a target of interventions to improve early childhood nutrition .
BACKGROUND	Understanding the maternal factors which mediate an intervention 's effect on young children 's diets is important , but has not been well investigated .
BACKGROUND	This research aimed to test whether maternal feeding knowledge , maternal feeding practices , maternal self-efficacy , and maternal dietary intakes acted as mediators of the effect of an intervention to improve child diet quality .
METHODS	The Melbourne Infant Feeding Activity and Nutrition Trial ( InFANT ) Program was a cluster-randomized controlled trial , conducted from 2008-2010 .
METHODS	This novel , low-dose , health promotion intervention was delivered quarterly over 15 months and involved educational activities , promotion of peer discussion , a DVD and written materials .
METHODS	Post-intervention , when children were approximately 18 months of age , child diets were assessed using multiple 24-hour recalls and a purpose-developed index of diet quality , the Obesity Protective Dietary Index .
METHODS	Maternal mediators were assessed using a combination of previously validated and purpose-deigned tools .
METHODS	Mediation analysis was conducted using the test of joint significance and difference of coefficients methods .
RESULTS	Across 62 parents ' groups in Melbourne , Australia , 542 parents were recruited .
RESULTS	Post - intervention , higher maternal feeding knowledge and lower use of foods as rewards was found to mediate the direct intervention effect on child diet quality .
RESULTS	While other aspects of maternal feeding practices , self-efficacy and dietary intakes did not act as mediators , they were associated with child diet quality .
CONCLUSIONS	Mediation analysis of this novel health promotion intervention showed the importance of maternal feeding knowledge and use of foods as rewards in impacting child diet quality .
CONCLUSIONS	The other maternal factors assessed were appropriate targets but further research on how to impact these in an intervention is important .
CONCLUSIONS	This evidence of intervention efficacy and mediation provides important insights for planning future interventions .
BACKGROUND	Current Controlled Trials ISRCTN81847050 , registered 23 November 2007 .

###24387929
OBJECTIVE	To present our experience of a novel technique , bladder neck sling suspension technique , in patients undergoing robot-assisted radical prostatectomy ( RARP ) and evaluate its efficacy for improving early continence outcomes after RARP in comparison with that of the standard technique .
METHODS	Fifty-seven consecutive patients underwent RARP between August 2011 and April 2012 .
METHODS	We performed RARP with and without bladder neck sling suspension technique for 27 ( sling group ) and 30 ( nonsling group ) patients , respectively , and compared the urinary outcome between the groups .
METHODS	Both subjective and objective assessments of urinary incontinence were performed before and after RARP .
RESULTS	The International Prostate Symptom Score ( P < .05 ) and International Consultation on Incontinence Questionnaire-Short Form ( P < .05 ) in the sling group were significantly lower , and Expanded Prostate Cancer Index Composite urinary incontinence score ( P < .05 ) in the sling group was higher than those in nonsling group , 4 weeks after RARP .
RESULTS	In addition , mean pad weight gain on 1-hour pad test in the sling group was significantly smaller than that in the nonsling group , 4 weeks after RARP ( P < .05 ) .
RESULTS	Both patient perception and objective data of urinary incontinence 4 weeks after RARP were better in the sling group than in the nonsling group .
RESULTS	Valsalva maneuver during cystography demonstrated that the mean posterior urethrovesical angle in the sling group was smaller than that in the nonsling group ( P < .001 ) .
CONCLUSIONS	Bladder neck sling suspension technique is a simple and feasible procedure in RARP and can improve the early return of continence after RARP , although additional larger studies are required to confirm this finding .

###24447587
OBJECTIVE	High sensitivity C-reactive protein ( hs-CRP ) , an inflammatory biomarker , has been demonstrated to contribute to the process of atherosclerosis and artery stenosis .
OBJECTIVE	The aim of this study was to evaluate whether hs-CRP level is associated with asymptomatic intracranial artery stenosis ( ICAS ) .
METHODS	A random sample of 5440 participants aged 40years or older ( 40.1 % women ) were enrolled in the Asymptomatic Polyvascular Abnormalities Community study in 2010-2011 .
METHODS	Information on the potential risk factors for ICAS was collected and the presence of ICAS was assessed by transcranial Doppler in 5309 participants .
METHODS	Participants were stratified into three groups according to hs-CRP levels .
METHODS	A multivariate logistic regression was used to examine the association between hs-CRP levels and asymptomatic ICAS .
RESULTS	The prevalence of asymptomatic ICAS was 13.2 % in this cohort .
RESULTS	The median of hs-CRP levels was positively associated with the increasing numbers of ICASs .
RESULTS	After adjusting for possible risk factors , hs-CRP 3mg/l remained significantly associated with asymptomatic ICAS ( odds ratio 1.28 , 95 % confidence interval 1.02-1 .61 ) .
CONCLUSIONS	In this large community-based study , subjects with higher hs-CRP levels showed a mild increase in the prevalence of asymptomatic ICAS , independent of traditional vascular risk factors .
CONCLUSIONS	hs-CRP is an independent predictor of asymptomatic ICAS and intracranial atherosclerotic burden .

###24898834
BACKGROUND	Diabetes and non-diabetic dysglycaemia are risk factors for accelerated cognitive decline .
BACKGROUND	In this planned substudy of the Outcome Reduction with Initial Glargine Intervention ( ORIGIN ) trial , we assessed whether normalising glucose with insulin glargine or administering omega-3 fatty acids in this population may slow this process or affect the development of cognitive impairment .
METHODS	The ORIGIN trial recruited participants older than 50 years with dysglycaemia who were taking either no or one oral glucose-lowering drug , who had additional risk factors for cardiovascular events , whose HbA1c was less than 9 % , and who were not taking insulin .
METHODS	Participants were recruited from 573 sites in 40 countries .
METHODS	Participants were randomly assigned to either titrated basal insulin glargine targeting a fasting plasma glucose concentration of 5.3 mmol/L or lower or standard care and to either omega-3 fatty acid ( 1 g ) or placebo by a factorial design .
METHODS	Outcome adjudicators and data analysts were masked to treatment allocation .
METHODS	Cognitive function was assessed by the Mini-Mental State Examination ( MMS ) and Digit Symbol Substitution ( DSS ) .
METHODS	The effect of insulin glargine or omega-3 fatty * acid on cognitive function over time , the annualised change in test scores , and the development of probable cognitive impairment were measured .
METHODS	All analyses were restricted to those participants who had a cognitive measurement at both baseline and at least one follow-up visit .
METHODS	The ORIGIN trial is registered with ClinicalTrials.gov , NCT00069784 .
RESULTS	Participants were randomly assigned between Sept 1 , 2003 , and Dec 15 , 2005 .
RESULTS	MMSE and DSS were assessed in 11,685 and 3392 ORIGIN participants ( mean age 63.4 years [ SD 7.7 ] ) , who were followed up for a median of 6.2 years ( IQR 5.8-6 .7 ) .
RESULTS	There was no difference in the rate of change of cognitive test scores between the insulin glargine and standard care groups ( for the MMSE 0.0046 , 95 % CI -0.0132 to 0.0224 , p = 0.39 ; and for the DSS -0.0362 , -0.2180 to 0.1455 , p = 0.34 ) or between the omega-3 fatty acid and placebo groups ( for the MMSE 0.0013 , 95 % CI -0.0165 to 0.0191 , p = 0.21 ; and for the DSS -0.0605 , -0.2422 to 0.1212 , p = 0.72 ) .
RESULTS	Similarly , the incidence of probable cognitive impairment did not differ between the insulin glargine and standard care groups ( p = 0.065 ) or the omega-3 fatty acid and placebo groups ( p = 0.070 ) .
RESULTS	In a subgroup analysis , allocation to insulin glargine versus standard care seemed to reduce the decline in the MMSE ( but not the DSS ) in participants with dysglycaemia but without evidence of diabetes ( pinteraction = 0.024 ) .
CONCLUSIONS	In this relatively young cohort of people with dysglycaemia , insulin mediated normoglycaemia and omega-3 fatty acid for over 6 years had a neutral effect on the rate of cognitive decline and on incident cognitive impairment .
CONCLUSIONS	Future studies should assess the effect of these interventions in an older cohort or the effect of other glucometabolic interventions on cognitive decline .
BACKGROUND	Sanofi .

###24777591
OBJECTIVE	Nomegestrol acetate ( NOMAC ) / 17-estradiol ( E2 ) is a monophasic oral contraceptive that contains a progesterone-derived progestogen ( NOMAC ) , and E2 , a bio-identical estrogen .
OBJECTIVE	The primary objective of this thorough QT/QTc study was to investigate whether once-daily administration of therapeutic ( 2.5 / 1.5 mg ) and supratherapeutic ( 12.5 / 7.5 mg ) doses of NOMAC/E2 were associated with prolongation of the mean Fridericia-corrected QT ( QTcF ) interval in electrocardiograms at steady-state concentrations of NOMAC/E2 versus placebo .
OBJECTIVE	The co-primary objective was to establish assay sensitivity after a single dose of moxifloxacin ( positive control ) .
METHODS	This was a randomized , double-blind , parallel-group trial comparing 2.5 / 1.5 mg of NOMAC/E2 ( therapeutic dose ) , 12.5 / 7.5 mg of NOMAC/E2 ( supratherapeutic dose ) , placebo , and moxifloxacin 400 mg .
METHODS	Double-blind study medication was administered from day -1 to 14 .
METHODS	Healthy women aged 18-50 years were randomized .
RESULTS	The largest time-matched mean QTcF difference compared with placebo for the therapeutic dose of NOMAC/E2 was 1.6 ms , with an upper limit ( UL ) of a one-sided 95 % confidence interval ( CI ) of 5.2 ms , and 3.1 ms with an UL 95 % CI of 7.0 ms for the supratherapeutic dose .
RESULTS	The UL for the time-matched QTcF differences compared with placebo were below the 10 ms threshold defined in the ICH E14 guideline for all time points , both for the therapeutic and the supratherapeutic dose .
RESULTS	For moxifloxacin , assay sensitivity was demonstrated .
CONCLUSIONS	This thorough QT/QTc study showed that therapeutic and supratherapeutic doses of NOMAC/E2 were not associated with clinically relevant QTc interval prolongation in healthy women after a 2-week period of dosing .

###24293993
BACKGROUND	Previous studies have demonstrated the potential beneficial effect of N-acetylcysteine ( NAC ) in chronic obstructive pulmonary disease ( COPD ) .
BACKGROUND	However , the required dose and responder phenotype remain unclear .
BACKGROUND	The current study investigated the effect of high-dose NAC on airway geometry , inflammation , and oxidative stress in COPD patients .
BACKGROUND	Novel functional respiratory imaging methods combining multislice computed tomography images and computer-based flow simulations were used with high sensitivity for detecting changes induced by the therapy .
METHODS	Twelve patients with Global Initiative for Chronic Obstructive Lung Disease stage II COPD were randomized to receive NAC 1800 mg or placebo daily for 3 months and were then crossed over to the alternative treatment for a further 3 months .
RESULTS	Significant correlations were found between image-based resistance values and glutathione levels after treatment with NAC ( P = 0.011 ) and glutathione peroxidase at baseline ( P = 0.036 ) .
RESULTS	Image-based resistance values appeared to be a good predictor for glutathione peroxidase levels after NAC ( P = 0.02 ) , changes in glutathione peroxidase levels ( P = 0.035 ) , and reduction in lobar functional residual capacity levels ( P = 0.00084 ) .
RESULTS	In the limited set of responders to NAC therapy , the changes in airway resistance were in the same order as changes induced by budesonide/formoterol .
CONCLUSIONS	A combination of glutathione , glutathione peroxidase , and imaging parameters could potentially be used to phenotype COPD patients who would benefit from addition of NAC to their current therapy .
CONCLUSIONS	The findings of this small pilot study need to be confirmed in a larger pivotal trial .

###24874549
OBJECTIVE	To describe and compare characteristics of older adults who drive after drinking and those who do not , whether an intervention addressing at-risk drinking reduces risk among those reporting driving after drinking , and reasons reported for driving after drinking .
METHODS	Secondary data analysis of a randomized trial testing the efficacy of a multifaceted intervention to reduce at-risk drinking among adults with a mean age of 68 years in primary care ( N = 631 ) .
RESULTS	Almost a quarter of at-risk drinkers reported driving after drinking ( N = 154 ) .
RESULTS	Compared to those who did not drive after drinking , those who did were more likely to be younger , male , and working .
RESULTS	They consumed a higher average number of drinks per week , had more reasons they were considered at-risk drinkers , and were more likely to meet at-risk drinking criteria due to amount of drinking and binge drinking .
RESULTS	Those driving after drinking at baseline reduced the frequency of this behavior at 3 and 12 months and there were no statistically significant differences in the proportions of persons still engaging in driving after drinking among those who were assigned to intervention or control groups .
RESULTS	Reasons for driving after drinking included not thinking that it was a problem and having to get home .
CONCLUSIONS	Driving after drinking is common in this population of older , at-risk drinkers recruited in primary care settings and , like younger adults , men and those reporting binge drinking are more likely to engage in this behavior .
CONCLUSIONS	Given that this behavior is dangerous and the population of older adults is fast growing , interventions addressing driving after drinking are needed .

###24796769
OBJECTIVE	Cost-effective guidance of therapeutic strategy in Crohn 's disease patients with secondary infliximab ( IFX ) treatment failure may be achieved by serum IFX and anti-IFX antibody ( Ab ) measurements by radioimmunoassay ( RIA ) .
OBJECTIVE	This study investigated implications of using other techniques for this purpose .
METHODS	This is a post hoc analysis of randomized clinical trial including 66 Crohn 's disease patients with IFX failure in whom IFX and anti-IFX Ab measurements by RIA had been used for therapeutic guidance .
METHODS	Samples were additionally assessed by enzyme-linked immunosorbent assay ( ELISA ) , homogeneous mobility shift assay ( HMSA ) , and functional cell-based reporter gene assay ( RGA ) .
RESULTS	IFX detection was comparable between assays ( 82 % RIA , 76 % ELISA , 88 % HMSA , and 74 % RGA ) , and it correlated significantly ( Pearson 's r = 0.91-0 .97 , P < 0.0001 ) .
RESULTS	However , IFX concentrations varied systematically between all pair of assays except RIA-RGA .
RESULTS	Anti-IFX Ab detection was variable ( 27 % RIA , 9 % ELISA , 33 % HMSA , and 11 % RGA ) , but correlated significantly ( Pearson 's r = 0.77-0 .96 ; P < 0.0001 ) .
RESULTS	Anti-IFX Abs detected by RIA and HMSA were often from sera without drug-neutralizing activity ( RGA ) .
RESULTS	Assays agreed on classification of underlying mechanism for treatment failure in most cases ( 79-94 % ) .
RESULTS	The majority ( 74-88 % ) failed IFX owing to pharmacodynamic problems , or had noninflammatory pathophysiology for symptoms resembling relapse .
RESULTS	Applied threshold for therapeutic vs. subtherapeutic IFX level influenced classifications .
RESULTS	The four different assays did not differ in terms of the ability to predict response to interventions defined by the algorithm .
CONCLUSIONS	Despite variable analytical properties , common assays result in similar classifications and interventions in patients with IFX treatment failure , and with comparable clinical outcomes .
CONCLUSIONS	Implications are , however , profound for the minority classified differently .

###24405257
METHODS	Randomized clinical trial .
OBJECTIVE	To examine the effectiveness of cervical traction in addition to exercise for specific subgroups of patients with neck pain .
BACKGROUND	Cervical traction is frequently used , but its effectiveness has not been adequately examined .
BACKGROUND	Existing studies have failed to target patients most likely to respond .
BACKGROUND	Traction is typically recommended for patients with cervical radiculopathy .
BACKGROUND	A prediction rule has been described to identify a narrower subgroup of patients likely to respond to cervical traction .
METHODS	Patients with neck pain and signs of radiculopathy were randomized to 4 weeks of treatment with exercise , exercise with mechanical traction , or exercise with over-door traction .
METHODS	Baseline assessment included subgrouping-rule status .
METHODS	The primary outcome measure ( Neck Disability Index , scored 0-100 ) and secondary outcome measure ( neck and arm pain intensity ) were assessed at 4 weeks , 6 months , and 12 months after enrollment .
METHODS	The primary analyses examined 2-way treatment-by-time interactions .
METHODS	Secondary analyses examined validity of the subgrouping rule by adding 3-way interactions .
RESULTS	Eighty-six patients ( 53.5 % female ; mean age , 46.9 years ) were enrolled in the study .
RESULTS	Intention-to-treat analysis found lower Neck Disability Index scores at 6 months in the mechanical traction group compared to the exercise group ( mean difference between groups , 13.3 ; 95 % confidence interval : 5.6 , 21.0 ) and over-door traction group ( mean difference between groups , 8.1 ; 95 % confidence interval : 0.8 , 15.3 ) , and at 12 months in the mechanical traction group compared to the exercise group ( mean difference between groups , 9.8 ; 95 % confidence interval : 0.2 , 19.4 ) .
RESULTS	Secondary outcomes favored mechanical traction at several time points .
RESULTS	The validity of the subgrouping rule was supported on the Neck Disability Index at the 6-month time point only .
CONCLUSIONS	Adding mechanical traction to exercise for patients with cervical radiculopathy resulted in lower disability and pain , particularly at long-term follow-ups .
CONCLUSIONS	The study protocol was registered at http://clinicaltrials.gov ( NCT00979108 ) .

###25660404
BACKGROUND	Nicotinic acetylcholine receptors ( nAChRs ) were identified on eosinophils and shown to regulate inflammatory responses , but nAChR expression on basophils has not been explored yet .
OBJECTIVE	We investigated surface receptor expression of nAChR 4 , 7 and 1/3/5 subunits on basophils .
OBJECTIVE	Furthermore , we examined the effects of ASM-024 , a synthetic nicotinic ligand , on in vitro anti-IgE and in vivo allergen-induced basophil activation .
METHODS	Basophils were enriched from the peripheral blood of allergic donors and the expression of nAChR subunits and muscarinic receptors was determined .
METHODS	Purified basophils were stimulated with anti-IgE in the presence of ASM-024 with or without muscarinic or nicotinic antagonists for the measurement of CD203c expression and histamine release .
METHODS	The effect of 9 days of treatment with 50 and 200 mg ASM-024 on basophil CD203c expression was examined in the blood of mild allergic asthmatics before and after allergen inhalation challenge .
RESULTS	nAChR 4 , 7 and 1/3/5 receptor subunit expression was detected on basophils .
RESULTS	Stimulation of basophils with anti-IgE increased CD203c expression and histamine release , which was inhibited by ASM-024 ( 10 ( -5 ) to 10 ( - ) ( 3 ) M , p < 0.05 ) .
RESULTS	The effect of ASM-024 was reversed in the presence of muscarinic and nicotinic antagonists .
RESULTS	In subjects with mild asthma , ASM-024 inhalation significantly inhibited basophil CD203c expression measured 24 h after allergen challenge ( p = 0.03 ) .
CONCLUSIONS	This study shows that ASM-024 inhibits IgE - and allergen-induced basophil activation through both nicotinic and muscarinic receptors , and suggests that ASM-024 may be an efficacious agent for modulating allergic asthma responses .

###25330122
OBJECTIVE	Aprepitant is a neurokinin 1 receptor antagonist approved for prevention of chemotherapy-induced and post-operative nausea and vomiting .
OBJECTIVE	Early studies demonstrated promising antidepressant activity as monotherapy , although this was unsupported by subsequent phase 3 trials .
OBJECTIVE	This phase 2 study evaluated whether aprepitant potentiated the antidepressant effects of paroxetine .
METHODS	Outpatients with major depressive disorder were randomized to aprepitant 200 mg + paroxetine 20 mg , paroxetine + placebo , or aprepitant + placebo for 6 weeks .
METHODS	The primary endpoint was change in HAMD-17 total score .
METHODS	Secondary/exploratory endpoints included changes in HAMA , CGI-S , CGI-I , and HAMD Item-1 scores at week 6 .
RESULTS	A total of 79 , 78 , and 79 patients received aprepitant + paroxetine , paroxetine + placebo , and aprepitant + placebo , respectively .
RESULTS	At week 6 , mean changes in HAMD-17 were -11.0 ( 95 % confidence interval [ CI ] : -12.7 , -9.4 ) , -11.7 ( 95 % CI : -13.3 , -10.0 ) , and -9.5 ( 95 % CI : -10.9 , -8.1 ) , respectively .
RESULTS	Pairwise comparisons of HAMD-17 change with combination therapy versus paroxetine alone demonstrated no significant difference ( p = 0.567 ) .
RESULTS	Changes in CGI-S , CGI-I , and HAMD Item-1 scores were also comparable , although there was a greater reduction in anxiety ( HAMA ) with paroxetine alone than aprepitant + paroxetine ( p = 0.045 ) .
RESULTS	Adverse events were generally more common with the combination than either monotherapy .
CONCLUSIONS	Concomitant use of aprepitant + paroxetine for 6 weeks did not provide greater antidepressant benefit compared with paroxetine + placebo in patients with major depression .

###25685075
BACKGROUND	A recent systematic review suggests that practice facilitation ( PF ) is a robust intervention for implementing evidence-based preventive care guidelines in primary care , but the ability of PF to improve chronic illness care remains unclear .
OBJECTIVE	To examine the specific activities and Chronic Care model ( CCM ) components that primary care practices implemented and sustained in response to a 12-month PF intervention .
METHODS	The ABC trial tested the effectiveness of PF to improve care for diabetes in 40 small community-based primary care practices that were randomized to `` initial '' or `` delayed '' intervention arms .
METHODS	A trained facilitator met with each practice over 12-months .
METHODS	Facilitators used interactive consensus building to help practices implement one or more of quality improvement activities based on the CCM .
METHODS	Facilitators prospectively recorded implementation activities reported by practice teams during monthly meetings and confirmed which of these were sustained at the end of the intervention .
RESULTS	37 practices implemented and sustained a total of 43 unique activities [ range 1-15 , average 6.5 ( SD = 2.9 ) ] .
RESULTS	The number ( % ) of practices that implemented 1 or more key activities in each CCM component varied : Patient Self-Management Support : 37 ( 100 % ) ; Clinical Information Systems : 24 ( 64.9 % ) , Delivery System Design : 14 ( 37.8 % ) , Decision Support : 13 ( 35.1 % ) , Community Linkages : 2 ( 5.4 % ) ; Healthcare System Support : 2 ( 2.7 % ) .
RESULTS	The majority of practices ( 59 % ) only implemented activities from 1 or 2 CCM components .
RESULTS	The number of sustained activities was associated with the number of PF visits , but not with practice characteristics .
CONCLUSIONS	In spite of the PF intervention , it was difficult for these small practices to implement comprehensive CCM changes .
CONCLUSIONS	Although practices implemented and sustained a remarkable number and variety of key activities , the majority of these focused on patient self-management support , as opposed to other components of the CCM , such as clinical information systems , decision support , delivery system redesign , and community linkages .

###24713413
OBJECTIVE	To demonstrate the superiority of estradiol valerate plus dienogest ( E ( 2 ) V/DNG ) over ethinylestradiol plus levonorgestrel ( EE/LNG ) in reducing the number of days with dysmenorrheic pain among women with primary dysmenorrhea .
METHODS	In a phase IIIb trial conducted at 44 centers worldwide between April 2009 and November 2010 , otherwise healthy women aged 14-50 years requesting contraception were randomized to daily oral administration of E ( 2 ) V/DNG ( n = 253 ) or EE/LNG ( n = 254 ) for three 28-daycycles .
METHODS	The primary efficacy variable was number of days with dysmenorrheic pain , the category of which ( none , mild , moderate , severe ) was self-assessed on a daily basis ( irrespective of menstrual bleeding status ) and recorded on diary cards .
METHODS	Notably , the women documented their pain as they experienced it before taking any ( permitted ) rescue medication .
RESULTS	Overall , 217 and 209 women receiving E ( 2 ) V/DNG and EE/LNG , respectively , completed the study .
RESULTS	The mean SD change from baseline in number of days with dysmenorrheic pain was -4.6 4.6 days and -4.2 4.2 days for the E ( 2 ) V/DNG and EE/LNG groups , respectively ( P = 0.34 ) .
CONCLUSIONS	Both E ( 2 ) V/DNG and EE/LNG led to considerable relief of dysmenorrheic complaints among women with primary dysmenorrhea , decreasing the number of days with dysmenorrheic pain from baseline to a similar extent .
CONCLUSIONS	ClinicalTrials.gov : NCT00909857 .

###24571858
BACKGROUND	Treating anaemia with red blood cell ( RBC ) transfusion is frequent , but controversial , in patients with septic shock .
BACKGROUND	Therefore we assessed characteristics and outcome associated with RBC transfusion in this group of high risk patients .
METHODS	We did a prospective cohort study at 7 general intensive care units ( ICUs ) including all adult patients with septic shock in a 5-month period .
RESULTS	Ninety-five of the 213 included patients ( 45 % ) received median 3 ( interquartile range 2-5 ) RBC units during shock .
RESULTS	The median pre-transfusion haemoglobin level was 8.1 ( 7.4-8 .9 ) g/dl and independent of shock day and bleeding .
RESULTS	Patients with cardiovascular disease were transfused at higher haemoglobin levels .
RESULTS	Transfused patients had higher Simplified Acute Physiology Score ( SAPS ) II ( 56 ( 45-69 ) vs. 48 ( 37-61 ) , p = 0.0005 ) , more bleeding episodes , lower haemoglobin levels days 1 to 5 , higher Sepsis-related Organ Failure Assessment ( SOFA ) scores ( days 1 and 5 ) , more days in shock ( 5 ( 3-10 ) vs. 2 ( 2-4 ) , p = 0.0001 ) , more days in ICU ( 10 ( 4-19 ) vs. 4 ( 2-8 ) , p = 0.0001 ) and higher 90-day mortality ( 66 vs. 43 % , p = 0.001 ) .
RESULTS	The latter association was lost after adjustment for admission category and SAPS II and SOFA-score on day 1 .
CONCLUSIONS	The decision to transfuse patients with septic shock was likely affected by disease severity and bleeding , but haemoglobin level was the only measure that consistently differed between transfused and non-transfused patients .

###25384211
BACKGROUND	For patients with neuromuscular disorders , lung insufflation with positive pressure is an accepted technique to increase inspiratory volume over VC to improve peak cough flow ( PCF ) .
OBJECTIVE	The aim of the study was to determine the pressure or volume required to achieve the highest individual PCF .
METHODS	In 40 patients dependent on noninvasive ventilation ( VC , 1611 % predicted ; age , 204 yr ) and in 20 healthy control subjects , insufflation capacity ( IC ) was measured during titration from 10 to maximum 40 mbar using intermittent positive pressure breathing ( IPPB ) or the lung insufflation assist maneuver ( LIAM ) of the VENTIlogic LS ventilator .
RESULTS	IPPB or LIAM titration resulted in a pressure-volume curve with an estimated total compliance of 0.230.11 L/kPa in the patients and 1.00.3 L/kPa in the controls and a plateau for IC at pressures between 30 and 40 mbar .
RESULTS	IPPB or LIAM improved VC from 451229 ml to a maximum IC ( ICmax ) of 1,027329 ml , and PCF improved from 10945 to 20262 L/min ( P < 0.01 for all ) .
RESULTS	The highest individual PCF was achieved with 276 mbar and an IC of 924379 ml , which was significantly below ICmax ( P < 0.01 ) .
CONCLUSIONS	A submaximal insufflation is ideal for generating the best individual PCF even in patients with severely reduced compliance of the respiratory system .
CONCLUSIONS	Optimum insufflation capacity can be achieved using IPPB or LIAM with moderate pressures .
CONCLUSIONS	Both techniques are equally effective and considered safe .

###25170796
OBJECTIVE	To increase the safety and effectiveness of treatments for overactive bladder ( OAB ) with moderate symptoms in elderly patients .
METHODS	Patients were examined at the Urodynamic Department of the Regional Diagnostic Center ( Vladivostok , Russian Federation ) from September 1 , 2012 to December 31 , 2012 .
METHODS	The assignment of patients [ n = 177 , average age 69.4 years , 98 women ( 55.4 % ) and 79 men ( 44.6 % ) ] was random and blind in this placebo-controlled study .
METHODS	Patients were distributed into subgroups according to the method of treatment as follows : group 1 : n = 57 , trospium 30 mg/day + solifenacin 10 mg/day ; group 2 : n = 61 , trospium 15 mg/day + solifenacin 5 mg/day ; group 3 : n = 59 , placebo .
METHODS	All patients underwent a urodynamic examination in accordance with international standards before and 2 months after treatment .
METHODS	ICIQ-SF questionnaires recommended by the International Continence Society ( ICS ) and bladder diaries were used to evaluate the clinical results .
METHODS	The clinical severity of the OAB symptoms and the effectiveness of the treatment were evaluated based on the frequency of episodes of incontinence ( EI ) per day .
METHODS	Three or fewer EI per day were considered moderate dysfunction of the lower urinary tract .
RESULTS	Groups of elderly patients with moderate symptoms of OAB who were treated with standard - and low-dose trospium and solifenacin demonstrated a significant increase in the median values of reflex volume , bladder capacity , and detrusor compliance and a decrease in the frequency of urination and urinary urgencies .
RESULTS	The frequency of EI in both of the main groups decreased by almost 2-fold in comparison to the initial data and reached the following values : group 1 : 1.27 ( -1.08 ) , p 0.05 ; group A2 : 1.49 ( -1.18 ) , p 0.05 .
RESULTS	The correlation with the decrease in the frequency of EI in these groups was r = 0.85 ( p 0.01 ) .
RESULTS	The percentage of patients with a significant decrease ( EI 1.0 ) among those treated with standard - and low-dose trospium and solifenacin increased synchronously , prompting us to suppose the absence of a direct correlation between medicine dose and therapeutic effect for moderate OAB symptoms .
CONCLUSIONS	The combination of low-dose trospium and solifenacin provides good clinical and urodynamic effects in elderly patients with moderate symptoms of OAB .
CONCLUSIONS	Combination of these drugs in standard doses for such patients is excessive .

###25591616
OBJECTIVE	Resistance to trastuzumab is a problem that remains to be solved in HER2-positive breast cancer .
OBJECTIVE	We aimed to characterize profiles of genetic and epigenetic alterations in cancer-related pathways in HER2-positive breast cancers , using biopsy tissue samples obtained from patients enrolled in a prospective neoadjuvant clinical trial .
METHODS	HER2-positive breast cancer tissue samples were collected and processed with the PAXgene Tissue System .
METHODS	A total of 24 breast cancers were analyzed .
METHODS	Genetic alterations of 409 cancer-related genes were analyzed by a bench-top next-generation sequencer .
METHODS	DNA methylation statuses were analyzed by a bead array with 485,512 probes .
RESULTS	The WNT pathway was potentially activated by aberrant methylation of its negative regulators , such as DKK3 and SFRP1 , in 9 breast cancers .
RESULTS	The AKT/mTOR pathway was activated by mutations of PIK3CA in 5 breast cancers .
RESULTS	The Notch pathway was potentially activated by mutations of NOTCH1 and NOTCH2 in 4 breast cancers .
RESULTS	The p53 pathway was inactivated by mutations of TP53 in 13 breast cancers and potentially by aberrant methylation of its downstream genes in 10 breast cancers .
RESULTS	Cell adhesion was affected by mutations of CDH1 in 1 breast cancer .
CONCLUSIONS	Genes involved in cancer-related pathways were frequently affected not only by genetic but also by epigenetic alterations in HER2-positive breast cancer .

###25340337
BACKGROUND	Interventions are needed to reduce poor perinatal health .
BACKGROUND	We trained community health workers ( CHWs ) as home visitors to address maternal/infant risks .
METHODS	In a cluster randomised controlled trial in Cape Town townships , neighbourhoods were randomised within matched pairs to 1 ) the control , healthcare at clinics ( n = 12 neighbourhoods ; n = 594 women ) , or 2 ) a home visiting intervention by CBW trained in cognitive-behavioural strategies to address health risks ( by the Philani Maternal , Child Health and Nutrition Programme ) , in addition to clinic care ( n = 12 neighbourhoods ; n = 644 women ) .
METHODS	Participants were assessed during pregnancy ( 2 % refusal ) and 92 % were reassessed at two weeks post-birth , 88 % at six months and 84 % at 18 months later .
METHODS	We analysed 32 measures of maternal/infant well-being over the 18 month follow-up period using longitudinal random effects regressions .
METHODS	A binomial test for correlated outcomes evaluated overall effectiveness over time .
METHODS	The 18 month post-birth assessment outcomes also were examined alone and as a function of the number of home visits received .
RESULTS	Benefits were found on 7 of 32 measures of outcomes , resulting in significant overall benefits for the intervention compared to the control when using the binomial test ( p = 0.008 ) ; nevertheless , no effects were observed when only the 18 month outcomes were analyzed .
RESULTS	Benefits on individual outcomes were related to the number of home visits received .
RESULTS	Among women living with HIV , intervention mothers were more likely to implement the PMTCT regimens , use condoms during all sexual episodes ( OR = 1.25 ; p = 0.014 ) , have infants with healthy weight-for-age measurements ( OR = 1.42 ; p = 0.045 ) , height-for-age measurements ( OR = 1.13 , p < 0.001 ) , breastfeed exclusively for six months ( OR = 3.59 ; p < 0.001 ) , and breastfeed longer ( OR = 3.08 ; p < 0.001 ) .
RESULTS	Number of visits was positively associated with infant birth weight 2500 grams ( OR = 1.07 ; p = 0.012 ) , healthy head-circumference-for-age measurements at 6 months ( OR = 1.09 , p = 0.017 ) , and improved cognitive development at 18 months ( OR = 1.02 , p = 0.048 ) .
CONCLUSIONS	Home visits to neighbourhood mothers by CHWs may be a feasible strategy for enhancing maternal/child outcomes .
CONCLUSIONS	However , visits likely must extend over several years for persistent benefits .
BACKGROUND	ClinicalTrials.gov NCT00996528 .

###24335363
OBJECTIVE	We have reported , in a randomized , controlled study , that tegafur-uracil ( UFT ) and protein-bound polysaccharide K ( PSK ) combination therapy significantly improves the 5-year disease-free survival rate and reduces the risk of recurrence compared to UFT alone for Stage II or III colorectal cancer .
OBJECTIVE	In this study , we examined the efficacy of PSK by stratifying patients according to the preoperative lymphocyte ratio ( Lym ) .
METHODS	In a randomized , controlled study , 205 patients were eligible ( 137 in the UFT/PSK group and 68 in the UFT group ) .
METHODS	Of these , 193 patients with available preoperative Lym data were analysed ( 131 in the UFT/PSK group and 62 in the UFT group ) .
RESULTS	Among patients with a preoperative Lym of < 35 % , the relapse-free survival ( RFS ) rate was 76.5 % in the UFT/PSK group and 55.8 % in the UFT group ( p = 0.008 ) .
RESULTS	However , in patients with a preoperative Lym of 35 % , the RFS rate did not differ between the 2 groups .
RESULTS	Similarly , overall survival was significantly higher in the UFT/PSK group than in the UFT group in patients with a preoperative Lym of < 35 % , whereas no intergroup difference was found among patients with a preoperative Lym of 35 % .
CONCLUSIONS	This study suggests that a low preoperative Lym is a good predictor for response to PSK in patients with Stage II or III colorectal cancer .

###24281290
OBJECTIVE	Persistent postsurgical pain ( PPP ) after thoracotomy effect 50 % to 80 % .
OBJECTIVE	Nerve damage and central sensitization involving NDMDAr activation may play an important role .
OBJECTIVE	This study evaluates the efficacy of adding intravenous ( IV ) or epidural ketamine to thoracic epidural analgesia ( TEA ) after thoracotomy .
METHODS	Double-blind randomized study on patients undergoing thoracotomy allocated to one of the following : group Kiv ( IV racemic ketamine 0.5 mg/kg preincisional +0.25 mg/kg/h for 48 h ) , group Kep ( epidural racemic ketamine 0.5 mg/kg preincisional +0.25 mg/kg/h for 48 h ) , or group S ( saline ) .
METHODS	Postoperative analgesia was ensured by TEA with ropivacaine and fentanyl .
METHODS	Pain visual analog scales ( VAS ) , Neuropathic Pain Symptom Inventory , Catastrophizing Scale , and Quantitative Sensory Testing , measuring both the peri-incisional and distant hyperalgesia area , were conducted preoperatively and postoperatively until 6 months .
METHODS	Plasma ketamine levels and stability of the analgesic solutions were analyzed .
RESULTS	A total of 104 patients were included .
RESULTS	PPP incidence was 20 % at 6 months .
RESULTS	Pain scores on coughing were significantly lower in Kiv and Kep than in S at 24 and 72 hours , but there were no differences afterwards .
RESULTS	There were no significant differences in pain at rest , Neuropathic Pain Symptom Inventory , and Catastrophizing Scale , or in the area of mechanical allodynia at any time .
RESULTS	Adverse effects were mild .
RESULTS	Plasma ketamine levels did not differ significantly between groups .
RESULTS	Analgesic solutions were stable .
CONCLUSIONS	Adding epidural or IV racemic ketamine to TEA after thoracotomy did not lead to any reduction in PPP or allodynia .
CONCLUSIONS	Epidural administration produced similar plasma ketamine levels to the IV route .

###24249538
BACKGROUND	Whether current postoperative surveillance regimes result in improved overall survival ( OS ) of patients with extremity sarcomas is unknown .
OBJECTIVE	We hypothesized that a less intensive followup protocol would not be inferior to the conventional followup protocol in terms of OS .
OBJECTIVE	We ( 1 ) assessed OS of patients to determine if less intensive followup regimens led to worsened survival and asked ( 2 ) whether chest radiograph followup group was inferior to CT scan followup group in detecting pulmonary metastasis ; and ( 3 ) whether less frequent ( 6-monthly ) followup interval was inferior to more frequent ( 3-monthly ) followup in detecting pulmonary metastasis and local recurrence .
METHODS	A prospective randomized single-center noninferiority trial was conducted between January 2006 and June 2010 .
METHODS	On the basis of 3-year survival of 60 % with intensive , more frequent followup , 500 nonmetastatic patients were randomized to demonstrate noninferiority by a margin ( delta ) of 10 % ( hazard ratio [ HR ] , 1.36 ) .
METHODS	The primary end point was OS at 3years .
METHODS	The secondary objective was to compare disease-free survival ( DFS ) ( time to recurrence ) at 3years .
METHODS	At minimum followup of 30months ( median , 42months ; range , 30-81months ) , 178 deaths were documented .
RESULTS	Three-year OS and DFS for all patients was 67 % and 52 % , respectively .
RESULTS	Three-year OS was 67 % and 66 % in chest radiography and CT groups , respectively ( HR , 0.9 ; upper 90 % confidence interval [ CI ] , 1.13 ) .
RESULTS	DFS rate was 54 % and 49 % in chest radiography and CT groups , respectively ( HR , 0.82 ; upper 90 % CI , 0.97 ) .
RESULTS	Three-year OS was 64 % and 69 % in 6-monthly and 3-monthly groups , respectively ( HR , 1.2 ; upper 90 % CI , 1.47 ) .
RESULTS	DFS was 51 % and 52 % in 6-monthly and 3-monthly groups , respectively ( HR , 1.01 ; upper 90 % CI , 1.2 ) .
RESULTS	Almost 90 % of local recurrences were identified by patients themselves .
CONCLUSIONS	Inexpensive imaging detects the vast majority of recurrent disease in patients with sarcoma without deleterious effects on eventual outcomes .
CONCLUSIONS	Patient education regarding self-examination will detect most instances of local recurrence although this was not directly assessed in this study .
CONCLUSIONS	Although less frequent visits adequately detected metastasis and local recurrence , this trial could not conclusively demonstrate noninferiority in OS for a 6-monthly interval of followup visits against 3-monthly visits .
METHODS	Level I , therapeutic study .
METHODS	See Guidelines for Authors for a complete description of levels of evidence .

###25176136
BACKGROUND	An elevated heart rate is an established marker of cardiovascular risk .
BACKGROUND	Previous analyses have suggested that ivabradine , a heart-rate-reducing agent , may improve outcomes in patients with stable coronary artery disease , left ventricular dysfunction , and a heart rate of 70 beats per minute or more .
METHODS	We conducted a randomized , double-blind , placebo-controlled trial of ivabradine , added to standard background therapy , in 19,102 patients who had both stable coronary artery disease without clinical heart failure and a heart rate of 70 beats per minute or more ( including 12,049 patients with activity-limiting angina [ class II on the Canadian Cardiovascular Society scale , which ranges from I to IV , with higher classes indicating greater limitations on physical activity owing to angina ] ) .
METHODS	We randomly assigned patients to placebo or ivabradine , at a dose of up to 10 mg twice daily , with the dose adjusted to achieve a target heart rate of 55 to 60 beats per minute .
METHODS	The primary end point was a composite of death from cardiovascular causes or nonfatal myocardial infarction .
RESULTS	At 3 months , the mean ( SD ) heart rate of the patients was 60.79.0 beats per minute in the ivabradine group versus 70.610.1 beats per minute in the placebo group .
RESULTS	After a median follow-up of 27.8 months , there was no significant difference between the ivabradine group and the placebo group in the incidence of the primary end point ( 6.8 % and 6.4 % , respectively ; hazard ratio , 1.08 ; 95 % confidence interval , 0.96 to 1.20 ; P = 0.20 ) , nor were there significant differences in the incidences of death from cardiovascular causes and nonfatal myocardial infarction .
RESULTS	Ivabradine was associated with an increase in the incidence of the primary end point among patients with activity-limiting angina but not among those without activity-limiting angina ( P = 0.02 for interaction ) .
RESULTS	The incidence of bradycardia was higher with ivabradine than with placebo ( 18.0 % vs. 2.3 % , P < 0.001 ) .
CONCLUSIONS	Among patients who had stable coronary artery disease without clinical heart failure , the addition of ivabradine to standard background therapy to reduce the heart rate did not improve outcomes .
CONCLUSIONS	( Funded by Servier ; SIGNIFY Current Controlled Trials number , ISRCTN61576291 . )

###25118146
BACKGROUND	Providing care for adolescents with type 1 diabetes is complex , demanding , and often unsuccessful .
BACKGROUND	Guided self-determination ( GSD ) is a life skills approach that has been proven effective in caring for adults with type 1 diabetes .
BACKGROUND	To improve care , GSD was revised for adolescents , their parents , and interdisciplinary healthcare providers ( HCP ) to create GSD-Youth ( GSD-Y ) .
BACKGROUND	We evaluated the impact of GSD-Y after it was integrated into pediatric outpatient visits versus treatment-as-usual , focusing on glycemic control and the development of life skills in adolescents with type 1 diabetes .
METHODS	Seventy-one adolescents ( mean age : 15 years , mean duration of diabetes : 5.7 years , mean HbA1c : 77 mmol/mol ( 9.1 % ) , upon entering the study ) from two pediatric departments were randomized into a GSD-Y group ( n = 37 , GSD-Y was provided during individual outpatient sessions ) versus a treatment-as-usual group ( n = 34 ) .
METHODS	The primary outcome was the HbA1c measurement .
METHODS	The secondary outcomes were life skills development ( assessed by self-reported psychometric scales ) , self-monitored blood glucose levels , and hypo - and hyperglycemic episodes .
METHODS	The analysis followed an intention-to-treat basis .
RESULTS	Fifty-seven adolescents ( 80 % ) completed the trial , and 53 ( 75 % ) completed a six-month post-treatment follow-up .
RESULTS	No significant effect of GSD-Y on the HbA1c could be detected in a mixed-model analysis after adjusting for the baseline HbA1c levels and the identity of the HCP ( P = 0.85 ) .
RESULTS	GSD-Y significantly reduced the amotivation for diabetes self-management after adjusting for the baseline value ( P = 0.001 ) .
RESULTS	Compared with the control group , the trial completion was prolonged in the GSD-Y group ( P < 0.001 ) , requiring more visits ( P = 0.05 ) with a higher rate of non-attendance ( P = 0.01 ) .
RESULTS	GSD-Y parents participated in fewer of the adolescents ' visits ( P = 0.05 ) compared with control parents .
CONCLUSIONS	Compared with treatment-as-usual , GSD-Y did not improve HbA1c levels , but it did decrease adolescents ' amotivation for diabetes self-management .
BACKGROUND	ISRCTN 54243636 , registered on 10 January 2010 .
BACKGROUND	Life skills for adolescents with type 1 diabetes and their parents .

###25500679
BACKGROUND	Two common general anaesthetic methods are total i.v. anaesthesia ( TIVA ) and inhalation anaesthesia , but it is unclear whether this affects the patient 's perception of their quality of recovery .
BACKGROUND	The Quality of Recovery-40 questionnaire ( QoR-40 ) is a valid and reliable method to evaluate the extent of functional recovery after surgery with general anaesthesia .
BACKGROUND	This study therefore compared patient recovery using the QoR-40 in surgical patients who received TIVA with those who received desflurane anaesthesia .
METHODS	Eighty females ( 20-65 years old ) undergoing thyroid surgery were prospectively recruited and randomized to either the TIVA ( effect-site target controlled infusion using propofol and remifentanil ) or DES ( desflurane inhalation with manual infusion of remifentanil ) groups .
METHODS	The QoR-40 was administered by an investigator blind to group allocation before surgery , and postoperative days 1 and 2 ( POD1 and POD2 ) .
METHODS	Additional data including the incidence of nausea or vomiting , the consumption of antiemetic and analgesic agents in the post-anaesthesia care unit , and the duration of the hospital stay , were collected in all cases .
RESULTS	The QoR-40 score on POD1 was significantly higher in the TIVA group compared with the DES group ( 174 vs 161 , respectively ; P = 0.004 ) , indicating a better quality of recovery in the TIVA group .
RESULTS	Among the five dimensions of the QoR-40 , physical comfort and physical independence were significantly better on POD1 and POD2 in the TIVA group .
CONCLUSIONS	This study demonstrates that the quality of recovery for female thyroid surgery patients is significantly better with TIVA compared with desflurane anaesthesia .
BACKGROUND	www.clinicaltrials.org ; ref. : NCT01760018 .

###24293405
OBJECTIVE	To determine the value of cardiac MRI for the monitoring and the prognosis of patients with acute myocarditis .
OBJECTIVE	Cardiac MRI plays an increasingly important role in the diagnosis of acute myocarditis .
OBJECTIVE	However , it is less established as a prognostic tool , which requires specific postprocessing of images .
METHODS	In a prospective pilot study , we assessed the prognostic value of the evolution in a simplified visual quantitative score ( SQS ) of late gadolinium enhancement ( LGE ) between initial hospitalization and 3 months later .
METHODS	The prognostic value was assessed at 1 year using a combination of death , heart transplant , and confirmed recurrence as main outcome .
RESULTS	Twenty-eight patients were included in this study .
RESULTS	A significant correlation was found between LGE measured by SQS and planimetry ( r = 0.95 , P < 0.001 ) .
RESULTS	Intraobserver and interobserver reproducibilities were good for SQS ( ICC = 0.95 [ 95 % CI : 0.86 to 0.98 ] , and 0.94 [ 95 % CI : 0.84 to 0.98 ] , respectively ) .
RESULTS	At initial hospitalization , patient characteristics between the two groups were similar .
RESULTS	Patients with stable or increased SQS suffered more frequently from clinical outcome events than patients with a decrease in SQS ( P = 0.02 ) .
CONCLUSIONS	Monitoring of the evolution of LGE using a simple visual score is of interest to identify patients at risk of pejorative prognosis after acute myocarditis .

###25550337
OBJECTIVE	To evaluate maintenance of response while reducing intravenous abatacept dose from ~ 10 mg/kg to ~ 5 mg/kg in patients with early rheumatoid arthritis ( RA ) who achieved disease activity score ( DAS ) 28 ( erythrocyte sedimentation rate , ESR ) < 2.6 .
METHODS	This 1-year , multinational , randomised , double-blind substudy evaluated the efficacy and safety of ~ 10 mg/kg and ~ 5 mg/kg abatacept in patients with early RA with poor prognosis who had reached DAS28 ( ESR ) < 2.6 at year 2 of the AGREE study .
METHODS	The primary outcome was time to disease relapse ( defined as additional disease-modifying antirheumatic drugs , 2 courses high-dose steroids , return to open-label abatacept ~ 10 mg/kg , or DAS28 ( C reactive protein ) 3.2 at two consecutive visits ) .
RESULTS	108 patients were randomised ( ~ 10 mg/kg , n = 58 ; ~ 5 mg/kg , n = 50 ) .
RESULTS	Three and five patients , respectively , discontinued , and four per group returned to open-label abatacept .
RESULTS	Relapse over time and the proportion of patients relapsing were similar in both groups ( 31 % ( ~ 10 mg/kg ) vs 34 % ( ~ 5 mg/kg ) ; HR : 0.87 ( 95 % CI 0.45 to 1.69 ) ) .
RESULTS	Mean steady-state trough serum concentration for the ~ 10 mg/kg group was 20.3-24 .1 g/mL , compared with 8.8-12 .0 g/mL for the ~ 5 mg/kg group .
CONCLUSIONS	This exploratory study suggests that abatacept dose reduction may be an option in patients with poor prognosis early RA who achieve DAS28 ( ESR ) < 2.6 after 1 year on abatacept ( ~ 10 mg/kg ) .
BACKGROUND	NCT00989235 .

###24307262
BACKGROUND	This study aimed to determine if delayed sodium ( 18 ) F-fluoride ( Na ( 18 ) F ) PET/CT imaging improves quantification of vascular calcification metabolism .
BACKGROUND	Blood-pool activity can disturb the arterial Na ( 18 ) F signal .
BACKGROUND	With time , blood-pool activity declines .
BACKGROUND	Therefore , delayed imaging can potentially improve quantification of vascular calcification metabolism .
RESULTS	Twenty healthy volunteers and 18 patients with chest pain were prospectively assessed by triple time-point PET/CT imaging at approximately 45 , 90 , and 180 minutes after Na ( 18 ) F administration .
RESULTS	For each time point , global uptake of Na ( 18 ) F was determined in the coronary arteries and thoracic aorta by calculating the blood-pool-corrected maximum standardized uptake value ( cSUV ( MAX ) ) .
RESULTS	A target-to-background ratio ( TBR ) was calculated to determine the contrast resolution at 45 , 90 , and 180 minutes .
RESULTS	Furthermore , we assessed whether the acquisition time-point affected the relation between cSUV ( MAX ) and the estimated 10-year risk for fatal cardiovascular disease ( SCORE % ) .
RESULTS	Coronary cSUV ( MAX ) ( P = .533 ) and aortic cSUV ( MAX ) ( P = .654 ) remained similar with time , whereas the coronary TBR ( P < .0001 ) and aortic TBR ( P < .0001 ) significantly increased with time .
RESULTS	Even though the contrast resolution improved with time , positive correlations between SCORE % and coronary cSUV ( MAX ) ( P < .020 ) and aortic cSUV ( MAX ) ( P < .005 ) were observed at all investigated time points .
CONCLUSIONS	Delayed Na ( 18 ) F PET/CT imaging does not improve quantification of vascular calcification metabolism .
CONCLUSIONS	Although contrast resolution improves with time , arterial Na ( 18 ) F avidity is invariant to the time between Na ( 18 ) F administration and PET/CT acquisition .
CONCLUSIONS	Therefore , the optimal PET/CT acquisition time-point to quantify vascular calcification metabolism is achieved as early as 45 minutes after Na ( 18 ) F administration .

###25471330
OBJECTIVE	To investigate the injection frequency and visual acuity ( VA ) outcomes with combination therapy ( ranibizumab plus verteporfin photodynamic therapy , PDT ) versus monotherapy ( ranibizumab ) .
METHODS	A total of 40 patients with exudative age-related macular degeneration were randomized 1:1 to ranibizumab 0.3 mg plus single standard verteporfin PDT or ranibizumab 0.3 mg plus sham PDT .
METHODS	Ranibizumab was administered 3 times monthly followed by ` as needed ' to month 12 based on predetermined vision/anatomical criteria .
METHODS	Retreatment rates , VA outcomes and safety were assessed .
RESULTS	During months 3-12 , combination therapy patients required fewer ranibizumab injections ( mean 1.3 ) compared with monotherapy patients ( 2.8 ) .
RESULTS	Mean VA improved by 9.0 letters with combination therapy versus 7.5 letters in the monotherapy group at month 12 .
RESULTS	Both treatment regimens were well tolerated .
CONCLUSIONS	The need for ranibizumab retreatment might be reduced by administering a single verteporfin PDT on the same day as the first ranibizumab injection , without compromising VA outcomes or safety .

###24768633
BACKGROUND	Anthrax vaccine adsorbed ( AVA ) administered intramuscularly ( IM ) results in fewer adverse events ( AEs ) than subcutaneous ( SQ ) administration .
BACKGROUND	Women experience more AEs than men .
BACKGROUND	Antibody response , female hormones , race , and body mass index ( BMI ) may contribute to increased frequency of reported injection site AEs .
METHODS	We analyzed data from the CDC AVA human clinical trial .
METHODS	This double blind , randomized , placebo controlled trial enrolled 1563 participants and followed them through 8 injections ( AVA or placebo ) over a period of 42 months .
METHODS	For the trial 's vaccinated cohort ( n = 1267 ) , we used multivariable logistic regression to model the effects of study group ( SQ or IM ) , sex , race , study site , BMI , age , and post-vaccination serum anti-PA IgG on occurrence of AEs of any severity grade .
METHODS	Also , in a women-only subset ( n = 227 ) , we assessed effect of pre-vaccination serum progesterone level and menstrual phase on AEs .
RESULTS	Participants who received SQ injections had significantly higher proportions of itching , redness , swelling , tenderness and warmth compared to the IM study group after adjusting for other risk factors .
RESULTS	The proportions of redness , swelling , tenderness and warmth were all significantly lower in blacks vs. non-black participants .
RESULTS	We found arm motion limitation , itching , pain , swelling and tenderness were more likely to occur in participants with the highest anti-PA IgG concentrations .
RESULTS	In the SQ study group , redness and swelling were more common for obese participants compared to participants who were not overweight .
RESULTS	Females had significantly higher proportions of all AEs compared to males .
RESULTS	Menstrual phase was not associated with any AEs .
CONCLUSIONS	Female and non-black participants had a higher proportion of AVA associated AEs and higher anti-PA IgG concentrations .
CONCLUSIONS	Antibody responses to other vaccines may also vary by sex and race .
CONCLUSIONS	Further studies may provide better understanding for higher proportions of AEs in women and non-black participants .

###25327732
OBJECTIVE	To compare the efficacy and safety of a new low-dose oral contraceptive pill ( YAZ ) containing drospirenone 3 mg and ethinylestradiol 20 g with placebo in reducing symptoms of premenstrual dysphoric disorder ( PMDD ) .
METHODS	This multicenter , double - blind , randomized clinical trial consisted of 2 run - in and 3 treatment cycles ( 84 days ) with daily symptom charting ; 187 women with symptoms of PMDD were randomized to either placebo group ( n = 94 ) or YAZ group ( n = 93 ) , and assessed with daily record of severity of problems scale ( DRSP ) and clinical global impressions scale ( CGI ) before , during and after the treatments .
METHODS	Hormones were administered for 24 days , followed by 4 days of inactive pills .
RESULTS	Compared with baseline level of DRSP , both groups got improvement after treatment ; the YAZ group ( median -28.7 , range : -82.5 to 2.3 ) had greater improvement than that in the placebo group ( median -23.7 , range : -86.0 to 11.8 ) , while there was not significant difference ( P > 0.05 ) .
RESULTS	The main adverse effects of YAZ included intermenstrual bleeding [ 13 % ( 12/93 ) versus 3 % ( 3/94 ) ] , menorrhagia [ 9 % ( 8/93 ) versus 1 % ( 1/94 ) ] , nausea [ 5 % ( 5/93 ) versus 4 % ( 4/94 ) ] and skin rash [ 4 % ( 4/93 ) versus 2 % ( 2/94 ) ] .
CONCLUSIONS	YAZ could improve symptoms of PMDD better than placebo , while without statistic significance in this study .
CONCLUSIONS	The most common adverse effects are intermenstrual bleeding , menorrhagia , nausea and rash .

###25733629
BACKGROUND	Complementary feeding recommendations ( CFRs ) with the use of locally available foods can be developed by using linear programming ( LP ) .
BACKGROUND	Although its potential has been shown for planning phases of food-based interventions , the effectiveness in the community setting has not been tested to our knowledge .
OBJECTIVE	We aimed to assess effectiveness of promoting optimized CFRs for improving maternal knowledge , feeding practices , and child intakes of key problem nutrients ( calcium , iron , niacin , and zinc ) .
METHODS	A community-intervention trial with a quasi-experimental design was conducted in East Lombok , West Nusa Tenggara Province , Indonesia , on children aged 9-16 mo at baseline .
METHODS	A CFR group ( n = 240 ) was compared with a non-CFR group ( n = 215 ) .
METHODS	The CFRs , which were developed using LP , were promoted in an intervention that included monthly cooking sessions and weekly home visits .
METHODS	The mother 's nutrition knowledge and her child 's feeding practices and the child 's nutrient intakes were measured before and after the 6-mo intervention by using a structured interview , 24-h recall , and 1-wk food-frequency questionnaire .
RESULTS	The CFR intervention improved mothers ' knowledge and children 's feeding practices and improved children 's intakes of calcium , iron , and zinc .
RESULTS	At the end line , median ( IQR ) nutrient densities were significantly higher in the CFR group than in the non-CFR group for iron [ i.e. , 0.6 mg/100 kcal ( 0.4-0 .8 mg/100 kcal ) compared with 0.5 mg/100 kcal ( 0.4-0 .7 mg/100 kcal ) ] and niacin [ i.e. , 0.8 mg/100 kcal ( 0.5-1 .0 mg/100 kcal ) compared with 0.6 mg/100 kcal ( 0.4-0 .8 mg/100 kcal ) ] .
RESULTS	However , median nutrient densities for calcium , iron , niacin , and zinc in the CFR group ( 23 , 0.6 , 0.7 , and 0.5 mg/100 kcal , respectively ) were still below desired densities ( 63 , 1.0 , 0.9 , and 0.6 mg/100 kcal , respectively ) .
CONCLUSIONS	The CFRs significantly increased intakes of calcium , iron , niacin , and zinc , but nutrient densities were still below desired nutrient densities .
CONCLUSIONS	When the adoption of optimized CFRs is constrained by economic access for or acceptability of nutrient-dense foods , other strategies need to be incorporated into interventions to ensure adequate intakes of these nutrients .

###25361841
BACKGROUND	The 1 year prevalence of depression in adolescents is about 2 % .
BACKGROUND	Treatment with antidepressant medication is not recommended for initial treatment in young people due to concerns over high side effects , poor efficacy and addictive potential .
BACKGROUND	Evidence suggests that cognitive behaviour therapy ( CBT ) is an effective treatment for depression and is currently one of the main treatment options recommended in adolescents .
BACKGROUND	Given the affinity young people have with information technology they may be treated effectively , more widely and earlier in their illness evolution using computer-administered CBT ( CCBT ) .
BACKGROUND	Currently little is known about the clinical and resource implications of implementing CCBT within the National Health Service for adolescents with low mood/depression .
BACKGROUND	We aim to establish the feasibility of running a fully powered randomised controlled trial ( RCT ) .
METHODS	Adolescents aged 12-18 with low mood/depression , ( scoring 20 on the Mood and Feelings Questionnaire ( MFQ ) ) , will be approached to participate .
METHODS	Consenting participants will be randomised to either a CCBT programme ( Stressbusters ) or accessing selected websites providing information about low mood/depression .
METHODS	The primary outcome measure will be the Beck Depression Inventory ( BDI ) .
METHODS	Participants will also complete generic health measures ( EQ5D-Y , HUI2 ) and resource use questionnaires to examine the feasibility of cost-effectiveness analysis .
METHODS	Questionnaires will be completed at baseline , 4 and 12-month follow-ups .
METHODS	Progress and risk will be monitored via the MFQ administered at each treatment session .
METHODS	The acceptability of a CCBT programme to adolescents ; and the willingness of clinicians to recruit participants and of participants to be randomised , recruitment rates , attrition rates and questionnaire completion rates will be collected for feasibility analysis .
METHODS	We will estimate ` numbers needed ' to plan a fully powered RCT of clinical and cost-effectiveness .
BACKGROUND	The current trial protocol received a favourable ethical opinion from Leeds ( West ) Research and Ethics Committee .
BACKGROUND	( Reference : 10/H1307/137 ) .
BACKGROUND	ISRCTN31219579 .

###24584926
OBJECTIVE	Assess longterm tolerability , safety , and efficacy of subcutaneous ( SC ) abatacept ( ABA ) in methotrexate-refractory patients with rheumatoid arthritis ( RA ) .
METHODS	The phase III , multinational Abatacept Comparison of Sub [ QU ] cutaneous Versus Intravenous in Inadequate Responders to MethotrexatE ( ACQUIRE ) trial comprised a 6-month , randomized , double-blind ( DB ) period , in which patients received intravenous ( IV ) or SC ABA , plus MTX , followed by an open-label , longterm extension ( LTE ) , in which patients received SC ABA , 125 mg/week .
METHODS	Safety and efficacy from the LTE ( 3.5 yrs of exposure ) are reported .
RESULTS	Patients who completed the DB period ( 1372/1385 , 99.1 % ) entered the LTE ; 1134 patients ( 82.7 % ) kept taking the treatment at time of reporting .
RESULTS	Mean ( SD ) was 31.9 months ( 6.8 ) ; median ( range ) exposure was 33.0 ( 8-44 ) months .
RESULTS	Patients entering the LTE had longstanding , moderate-to-severe disease [ mean 7.6 ( 7.9 ) yrs and DAS28 ( C-reactive protein ) 6.2 ( 0.9 ) ] .
RESULTS	Incidence rates ( events/100 patient-yrs ) were reported for serious adverse events ( 8.76 , 95 % CI 7.71 , 9.95 ) , infections ( 44.80 , 95 % CI 41.76 , 48.01 ) , serious infections ( 1.72 , 95 % CI 1.30 , 2.27 ) , malignancies ( 1.19 , 95 % CI 0.86 , 1.66 ) , and autoimmune events ( 1.31 , 95 % CI 0.95 , 1.79 ) .
RESULTS	Twenty-seven patients ( 2 % ) experienced injection-site reactions ; all except 1 were mild .
RESULTS	American College of Rheumatology 20 , 50 , and 70 responses achieved during the DB period were maintained through the LTE , and on Day 981 were 80.2 % ( 95 % CI 77.2 , 83.2 ) , 63.5 % ( 95 % CI 58.2 , 68.9 ) , and 39.5 % ( 95 % CI 34.0 , 44.9 ) for patients who kept taking SC ABA , and 80.0 % ( 95 % CI 77.0 , 83.0 ) , 63.2 % ( 95 % CI 57.8 , 68.7 ) , and 39.2 % ( 95 % CI 33.7 , 44.7 ) for those who switched from IV to SC ABA .
CONCLUSIONS	These findings support SC ABA as a well-tolerated and efficacious longterm treatment for patients with RA and inadequate response to MTX ( ClinicalTrials.gov identifier NCT00559585 ) .

###24285757
BACKGROUND	Alvimopan is indicated to accelerate the time to gastrointestinal recovery following partial bowel resection with primary anastomosis .
BACKGROUND	The approved dosing regimen includes an initial dose prior to surgery and 12 mg twice daily after surgery for up to 7 days ; however , there are no human studies evaluating the need for the preoperative dose .
BACKGROUND	We report our experience with gastrointestinal recovery when the preoperative dose is omitted .
OBJECTIVE	To evaluate the efficacy of alvimopan therapy when the preoperative dose is not administered .
METHODS	This retrospective study included elective surgery patients who underwent bowel resection with primary anastomosis without colostomy or ileostomy .
METHODS	The study compared ( a ) patients who received alvimopan and received a dose preoperatively , ( b ) patients who received alvimopan but did not receive a dose preoperatively , and ( c ) matched control patients who did not receive alvimopan .
METHODS	Length of stay following bowel resection , direct hospital costs , time to first bowel movement , and time to oral diet were evaluated .
RESULTS	Of 50 patients who received alvimopan , 27 received the preoperative dose and 23 did not .
RESULTS	These 50 patients were matched to similar control patients who received no alvimopan during their admission for resection .
RESULTS	Compared with controls , time to discharge was significantly shorter in patients who received alvimopan , regardless of whether the preoperative dose was administered ( P < .001 ) or omitted ( P = .03 ) .
RESULTS	Patients who did not receive the preoperative dose still experienced faster time to first bowel movement ( 71 vs 97 hours ; P = .006 ) and faster time to first diet ( 17 vs 54 hours ; P < .001 ) than non-alvimopan users .
CONCLUSIONS	Patients receiving the approved alvimopan dosing regimen experienced the most rapid recovery of gastrointestinal function .
CONCLUSIONS	However , administering alvimopan only postoperatively ( if the preoperative dose is omitted ) may still reduce the severity of postoperative ileus .

###24992975
BACKGROUND	Retrospective studies have shown that a significant number of ovarian borderline tumors , ovarian metastases , and nonepithelial tumors were erroneously diagnosed as ovarian carcinomas .
BACKGROUND	This may lead to unnecessary morbidity , suboptimal therapeutic modalities , and unintended bias in clinical trials .
BACKGROUND	The aim of this study was to investigate the frequency and clinical significance of such diagnostic discrepancies .
METHODS	Original histological slides from patients with ovarian carcinomas included in phase III chemotherapy trials of the Working Group on Gynecological Oncology ( AGO ) were reviewed by at least two specialized pathologists .
METHODS	Diagnostic discrepancies were classified as being either clinically relevant ( major ) or clinically not relevant ( minor ) .
RESULTS	A total of 454 out of 533 patients from the AGO OVAR11 ( ICON7 ) trial gave consent to the second opinion on the pathology results .
RESULTS	All of the 104 institutes of pathology responsible for the original diagnoses contributed to the study .
RESULTS	The first diagnosis and the second opinion pathology review were identical in 295 out of 454 ( 65 % ) cases .
RESULTS	In 128 cases ( 28.2 % ) a minor discrepancy was found and 31 cases ( 6.8 % ) were shown to have a major discrepancy .
CONCLUSIONS	The assumption of a significant number or erroneous diagnoses in chemotherapy trials of ovarian carcinomas was confirmed .
CONCLUSIONS	A pathology review seems therefore desirable and may help to reduce unnecessary morbidity and optimize therapeutic strategies .
CONCLUSIONS	Moreover , improvement of quality in therapy trials may become possible .
CONCLUSIONS	In another study a new concept allowing a rapid pathology review before randomization of patients has now been successfully tested and it may well have potential to form the basis for modern networking consultation pathology .

###25102297
OBJECTIVE	To compare procedure times and complication rates of preincisional ultrasonographic ( US ) evaluation and perioperative US guidance in percutaneous dilatational tracheostomy ( PDT percutaneous dilatational tracheostomy ) with those of the current standard of care , PDT percutaneous dilatational tracheostomy performed without image guidance .
METHODS	Between December 2007 and January 2011 , 341 patients were included in this institutional review board-approved study after informed consent was obtained from the patients or their relatives .
METHODS	The patients were divided randomly into two groups .
METHODS	In group A ( n = 166 ) , the possible causes of complications , such as aberrations of tracheal , thyroidal , and vascular structures , were determined with US , and tracheal measurements were performed by using US .
METHODS	The clinician 's initial considerations at physical examination were compared with the US findings .
METHODS	PDT percutaneous dilatational tracheostomy was subsequently performed with US guidance in suitable cases .
METHODS	In group B ( n = 175 ) , PDT percutaneous dilatational tracheostomy was performed solely on the basis of physical landmarks .
METHODS	The procedure times and complication rates were compared across groups by using the Fisher exact test .
RESULTS	In group A , the puncture sites designated at the physical examination were reconsidered in 39 ( 23.8 % ) of 164 cases .
RESULTS	The perioperative complication rates were slightly lower in group A ( 7.8 % [ 12 of 154 ] ) than in group B ( 15.0 % [ 25 of 167 ] ) ; however , the difference did not achieve statistical significance ( P = .054 ) .
RESULTS	The mean procedure times for groups A and B were 24.09 minutes 8.05 ( standard deviation ) ( range , 14-68 minutes ) and 18.62 minutes 6.34 ( range , 12-81 minutes ) , respectively ( P = .001 ) , and the numbers of patients in each group who required multiple puncture attempts were six ( 3.9 % ) of 154 and 23 ( 13.6 % ) of 169 ( P = .003 ) , respectively .
CONCLUSIONS	The use of US guidance before and during PDT percutaneous dilatational tracheostomy could render the procedure easier and safer , with fewer complications but a slightly longer procedure time .

###24667838
OBJECTIVE	To assess erectile function in middle-aged and older men with asexuality status and further analyze their specific reasons for this condition .
METHODS	Men who had regular sexual intercourse attempts ( sex frequency 1 time per month ) were classified into mild erectile dysfunction ( ED ) , moderate to severe ED and non-ED according to International Index of Erectile Function-5 , and men having no sexual intercourse attempts for at least 6 months were defined as having an asexuality status .
METHODS	The risk factors associated with ED were collected in a sample of 1,531 Chinese men aged 40 to 80 years , and the self-report reasons for asexuality were recorded in asexual cohort individually .
METHODS	Comparative analyses and multivariate regression models were conducted among these groups .
RESULTS	The prevalence rates of ED and asexuality status were 49.9 % and 37.2 % .
RESULTS	The asexuality status group had higher risk factors than the moderate to severe ED group in terms of old age ( age 65 , adjusted odds ratio ( OR ) 17.69 versus ( Vs. ) 7.19 ) , diabetes ( crude OR : 2.40 Vs. 2.36 ) and hypertension ( crude OR : 1.78 Vs. 1.72 ) .
RESULTS	The specific reasons for the asexuality status were `` erectile difficulty '' ( 52.9 % ) , `` do not care about sexuality '' ( 53.5 % ) '' , `` no longer necessary to have sexuality at this age '' ( 47.7 % ) , `` severe stress '' ( 44.4 % ) , `` severe fatigue '' ( 26.3 % ) and `` masturbation '' ( 26.9 % ) .
CONCLUSIONS	Men with an asexual status suffer from higher risk factors for ED than men with moderate to severe ED .
CONCLUSIONS	The majority of this asexual status could be attributed to a full ED , although the reasons for this transient asexuality also involved sexual attitudes and interests , sexual partners and masturbation .

###25714536
OBJECTIVE	The aim of this study was to evaluate the Eye Retinopathy Trainer as a teaching tool for direct ophthalmoscopy examination by comparing it with the traditional method using volunteers .
METHODS	Fourth year medical students received training in direct ophthalmoscopy using a simulation tool and human volunteers .
METHODS	Ninety students were randomized into a Simulation Group or a Control Group by the inclusion or absence of the simulation model in classroom practice .
METHODS	Differences between the groups were analyzed using unpaired Student 's t-test .
RESULTS	The Simulation Group was superior to the Control Group , with 51.06 % successful in performing fundus examination in both the anatomical model simulation and the human model in comparison with 21.15 % in the Control Group .
CONCLUSIONS	The Eye Retinopathy Trainer appears to be an effective teaching tool for practice and improvement of ophthalmologic examination among fourth year medical students .

###24373998
BACKGROUND	PT302 is a sustained-release exenatide under clinical development for the treatment of type 2 diabetes mellitus .
OBJECTIVE	The aim of this study was to evaluate the pharmacokinetic properties , pharmacodynamic properties , and tolerability of PT302 after a single subcutaneous injection in healthy individuals .
METHODS	A dose-block randomized , double-blind , placebo-controlled , dose-escalating study ( 0.5 , 1 , 2 , and 4 mg ) was performed in 34 healthy individuals .
METHODS	The plasma concentrations of exenatide in serial blood samples were quantified for 56 days after dosing with an exendin-4 fluorescent immunoassay kit .
METHODS	Noncompartmental analysis was performed to assess the pharmacokinetic characteristics of PT302 .
METHODS	Oral glucose tolerance tests were repeated weekly until day 42 ; the concentrations of serum glucose , serum C-peptide , plasma insulin , and plasma glucagon were measured for 2 hours to evaluate the pharmacodynamic characteristics of PT302 .
METHODS	Clinical laboratory tests , vital signs , physical examinations , 12-lead ECGs , and adverse events were monitored to evaluate the safety profile and tolerability .
RESULTS	PT302 exhibits a biphasic pharmacokinetic profile , with the initial peak occurring 2 hours after administration .
RESULTS	PT302 was quantifiable in the plasma until days 23 , 30 , 32 , and 55 ( median ) in the 0.5-mg , 1-mg , 2-mg , and 4-mg dosage groups of PT302 , respectively .
RESULTS	Systemic exposure increased proportionally to the dose during the entire dose range investigated .
RESULTS	The pharmacodynamic effect of PT302 on the postprandial response of insulin and C-peptide was significant on days 21 to 28 at the 4-mg dose and was positively correlated with plasma exenatide concentrations , whereas the correlations with glucose and glucagon were not significant .
RESULTS	The fasting levels of these pharmacodynamic biomarkers were not altered by PT302 .
RESULTS	The most common adverse events were injection site induration and pruritus related to inflammatory foreign body reaction , which were mild and spontaneously resolved within several weeks .
CONCLUSIONS	The pharmacokinetic characteristics of PT302 were biphasic and dose proportional .
CONCLUSIONS	A single 4-mg dose of PT302 significantly increased the insulin and C-peptide response to oral glucose loading and was well tolerated in healthy individuals .

###24767296
OBJECTIVE	To compare the effects of short-term and long-term thromboprophylaxis after total hip replacement on coagulation indicators in plasma sampled before and 1 , 7 and 35 days post-operation .
METHODS	A total of 40 patients scheduled for elective total hip replacement were randomly assigned into the short-term ( n = 20 ) or long-term ( n = 20 ) thromboprophylaxis groups on oral rivaroxaban 10 mg once daily for 7 or 35 days .
METHODS	The primary efficacy hemostatic variables included thrombin-antithrombin complexes ( TAT ) , prothrombin fragment 1 +2 ( F1t2 ) , D-dimer and fibrinogen ( Fib ) preoperatively and at Days 1 , 7 and 35 postoperatively .
METHODS	And ultrasonography was performed on all patients preoperatively and at days 7 and 35 postoperatively to exclude deep vein thrombosis of lower extremities .
RESULTS	None of them had deep vein thrombosis ( DVT ) of lower extremities .
RESULTS	Among them , TAT , F1 +2 , D-dimer and Fib post-operation were higher than those preoperative baseline values .
RESULTS	TAT and D-dimer peaked at day 1 postoperatively while the peaks of F1 +2 and Fib appeared at day 7 postoperatively .
RESULTS	At Day 35 post-operation , the levels of TAT and F1 +2 in the long-term thromboprophylaxis group were significantly lower than those of the short-term thromboprophylaxis group ( P < 0.05 ) .
CONCLUSIONS	The status of hypercoagulability may sustain at least 35 days after total hip replacement .
CONCLUSIONS	Though not completely eliminated , it can still be reduced by prolonged thromboprophylaxis .
CONCLUSIONS	However , according to ultrasonography , the effects of short-term and long-term thromboprophylaxis on the incidence rate of DVT remain to be further explored .

###24571282
BACKGROUND	Using a multidimensional approach , we assessed young women 's knowledge of oral contraceptives ( OC ) and its influence on OC continuation rates .
METHODS	We used data from 659 women aged 13-25 years participating in a randomized controlled trial of an educational text message OC continuation intervention .
METHODS	Women received 6 months of daily text messages or routine care .
METHODS	At baseline and 6 months , we administered a comprehensive 41-item questionnaire measuring knowledge of OC 's mechanism , effectiveness , use , side effects , risks , and benefits .
METHODS	We ascertained OC continuation status and reasons for discontinuation at 6 months .
METHODS	We analyzed relationships between OC knowledge and continuation with multivariable logistic regression .
RESULTS	Young women scored , on average , 22.8 out of 41 points on the OC knowledge assessment at baseline and 24.7 points at 6 months .
RESULTS	The 6-month OC continuation rate was 59 % .
RESULTS	OC continuers had > 2-points-higher OC knowledge scores at 6 months than discontinuers ( p < 0.001 ) .
RESULTS	Those who reported discontinuing their OCs for side effects and forgetfulness scored > 2 points lower than women who discontinued for other reasons ( p-values < 0.001 ) .
RESULTS	In multivariable regression models , each correct response on the baseline and 6-month knowledge assessments was associated with a 4 % and 6 % increased odds of OC continuation , respectively .
RESULTS	Six-month OC knowledge scores were negatively associated with OC discontinuation due to side effects ( odds ratio [ OR ] 0.94 ) and forgetfulness ( OR 0.88 ) .
CONCLUSIONS	OC knowledge , which was low among young women in our study , was associated with OC continuation and common reasons for discontinuation .
CONCLUSIONS	Continued efforts to characterize relationships between OC knowledge and behavior and to test the effectiveness of different components of interventions aimed at increasing knowledge , addressing side effects , and improving use of OCs are warranted .

###25149322
BACKGROUND	Fabry disease is an X-linked lysosomal storage disorder affecting both males and females with tremendous genotypic/phenotypic variability .
BACKGROUND	Concentrations of globotriaosylceramide ( Gb3 ) , globotriaosylsphingosine ( lyso-Gb3 ) / related analogues were investigated in pediatric and adult Fabry cohorts .
BACKGROUND	The aims of this study were to transfer and validate an HPLC-MS/MS methodology on a UPLC-MS/MS new generation platform , using an HPLC column , for urine analysis of treated and untreated pediatric and adult Fabry patients , to establish correlations between the excretion of Fabry biomarkers with gender , treatment , types of mutations , and to evaluate the biomarker reliability for early detection of pediatric Fabry patients .
METHODS	A UPLC-MS/MS was used for biomarker analysis .
RESULTS	Reference values are presented for all biomarkers .
RESULTS	Results show that gender strongly influences the excretion of each biomarker in the pediatric Fabry cohort , with females having lower urinary levels of all biomarkers .
RESULTS	Urinary distribution of lyso-Gb3 / related analogues in treated Fabry males was similar to the untreated and treated Fabry female groups in both children and adult cohorts .
RESULTS	Children with the late-onset p.N215S mutation had normal urinary levels of Gb3 , and lyso-Gb3 but abnormal levels of related analogues .
CONCLUSIONS	In this study , Fabry males and most Fabry females would have been diagnosed using the urinary lyso-Gb3 / related analogue profile .

###24428733
BACKGROUND	Binge drinking is responsible for over half of all alcohol-related deaths and results in significant health and economic costs to individuals and society .
BACKGROUND	Knowledge of genetic aspects of this behavior , particularly as it emerges in young adulthood , could lead to improved treatment and prevention programs .
METHODS	We have focused on the association of variation in neuronal nicotinic receptor subunit genes ( CHRNs ) in a cohort of 702 Hispanic and non-Hispanic White young adults who are part of the Social and Emotional Contexts of Adolescent Smoking Patterns ( SECASP ) study .
METHODS	Fifty-five single nucleotide polymorphisms ( SNPs ) covering the variation in 5 CHRNs ( CHRNA4 , CHRNB2 , CHRNA2 , CHRNB3A6 , and CHRNA5A3B4 ) were studied .
RESULTS	Frequency of binge drinking and other correlated alcohol consumption measures were significantly associated with SNPs in CHRNA4 ( p-values ranged from 0.0003 to 0.02 ) , but not with SNPs in other CHRNs .
RESULTS	This association was independent of smoking status in our cohort .
CONCLUSIONS	Variants in CHRNA4 may contribute to risk of binge drinking in young adults in this cohort .
CONCLUSIONS	Results will need to be confirmed in independent samples .

###24245838
OBJECTIVE	Informal caregivers ( family and friends ) of people with cancer are often unprepared for their caregiving role , leading to increased burden or distress .
OBJECTIVE	Comprehensive Health Enhancement Support System ( CHESS ) is a Web-based lung cancer information , communication , and coaching system for caregivers .
OBJECTIVE	This randomized trial reports the impact on caregiver burden , disruptiveness , and mood of providing caregivers access to CHESS versus the Internet with a list of recommended lung cancer websites .
METHODS	A total of 285 informal caregivers of patients with advanced nonsmall cell lung cancer were randomly assigned to a comparison group that received Internet or a treatment group that received Internet and CHESS .
METHODS	Caregivers were provided a computer and Internet service if needed .
METHODS	Written surveys were completed at pretest and during the intervention period bimonthly for up to 24 months .
METHODS	Analyses of covariance ( ANCOVAs ) compared the intervention 's effect on caregivers ' disruptiveness and burden ( CQOLI-C ) , and negative mood ( combined Anxiety , Depression , and Anger scales of the POMS ) at 6 months , controlling for blocking variables ( site , caregiver 's race , and relationship to patient ) and the given outcome at pretest .
RESULTS	Caregivers randomized to CHESS reported lower burden , t ( 84 ) = 2.36 , p = .021 , d = .39 , and negative mood , t ( 86 ) = 2.82 , p = .006 , d = .44 , than those in the Internet group .
RESULTS	The effect on disruptiveness was not significant .
CONCLUSIONS	Although caring for someone with a terminal illness will always exact a toll on caregivers , eHealth interventions like CHESS may improve caregivers ' understanding and coping skills and , as a result , ease their burden and mood .

###26016867
BACKGROUND	Krill is an increasingly popular source of marine n-3 ( -3 ) PUFA that is seen as a premium product .
BACKGROUND	However , to our knowledge , the effect of krill-oil supplementation on insulin sensitivity in humans has not been reported .
OBJECTIVE	We assessed whether supplementation with a blend of krill and salmon ( KS ) oil [ which is rich in eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) ] affects insulin sensitivity in overweight men .
METHODS	The design was a randomized , double-blind , controlled crossover trial .
METHODS	A total of 47 men with a mean SD age of 46.5 5.1 y , who were overweight [ body mass index ( in kg/m ( 2 ) ) from 25 to 30 ] but otherwise healthy , received 5 1-g capsules of KS oil or a control ( canola oil ) for 8 wk and crossed over to another treatment after an 8-wk washout period .
METHODS	The primary outcome was insulin sensitivity assessed by using the Matsuda method from an oral-glucose-tolerance test .
METHODS	Secondary outcomes included lipid profiles , inflammatory markers , 24-h ambulatory blood pressure , and carotid artery intimamedia thickness .
RESULTS	Unexpectedly , insulin sensitivity ( per the Matsuda index ) was 14 % lower with the KS oil than with the control oil ( P = 0.049 ) .
RESULTS	A mediation analysis showed that , after controlling for the likely positive effects of blood EPA and DHA ( i.e. , the omega-3 index ) , the reduction in insulin sensitivity after KS-oil supplementation was more marked [ 27 % lower than with the control oil ( P = 0.009 ) ] .
CONCLUSIONS	Supplementation with a blend of KS oil is associated with decreased insulin sensitivity .
CONCLUSIONS	Thus , krill-oil supplementation in overweight adults could exacerbate risk of diabetes and cardiovascular disease .
CONCLUSIONS	This trial was prospectively registered at the Australian New Zealand Clinical Trials Registry as ACTRN12611000602921 .

###24812896
OBJECTIVE	To observe the clinical efficacy of Tongfu Mixture ( TM ) for post-ERCP pancreatitis ( PEP ) .
METHODS	Totally 54 PEP patients were randomly assigned to the control group ( treated by routine therapy , 26 cases ) and the TM treatment group ( treated by TM , 28 cases ) .
METHODS	Clinical indices including the alleviation time of abdominal pain/distention , gastrointestinal function recovery time , and the post-surgical length of stay were observed .
METHODS	Blood amylase ( AMY ) , C-reactive protein ( CRP ) , plasma endotoxin ( PLS ) , TNF-alpha , and IL-6 were detected before surgery , 12 h , 48 h , and 96 h after surgery .
RESULTS	The alleviation time of abdominal pain/distention , the gastrointestinal function recovery time , and the post-surgical length of stay were obviously shorter in the TM treatment group than those in the control group ( P < 0.05 ) .
RESULTS	The recovery of AMY and CRP were better in the TM treatment group than in the control group at post-operative 48 h and 96 h ( P < 0.05 ) .
RESULTS	The levels of LPS , TNF-alpha , and IL-6 were lower in the TM group than in the control group at post-operative 96 h ( P < 0.05 ) .
CONCLUSIONS	TM showed better clinical efficacy and could significantly decrease the post-surgical length of stay .
CONCLUSIONS	post-ERCP pancreatitis ; integrative medicine ; Tongfu Mixture

###25300392
BACKGROUND	Preventive health checks may identify individuals with an unhealthy lifestyle and motivate them to change behaviour .
BACKGROUND	However , knowledge about the impact of the different components included in preventive health checks is deficient .
BACKGROUND	The aim of this trial is to evaluate whether including cardiorespiratory fitness testing in preventive health checks 1 ) increases cardiorespiratory fitness level and motivation to change physical activity behaviour and 2 ) reduces physical inactivity prevalence and improves self-rated health compared with preventive health checks without fitness testing .
METHODS	An open-label , household-cluster , randomized controlled trial with a two-group parallel design is used .
METHODS	The trial is embedded in a population-based health promotion program , `` Check your Health Preventive Program '' , in which all 30-49 year-old citizens in a Danish municipality are offered a preventive health check .
METHODS	In each arm of the trial , 750 citizens will be recruited ( 1,500 in total ) .
METHODS	The primary outcome is cardiorespiratory fitness level assessed by submaximal cycle ergometer testing after one year .
METHODS	An intermediate outcome is the percentage of participants increasing motivation for physical activity behaviour change between baseline and two-weeks follow-up assessed using the Transtheoretical Model 's stages of change .
METHODS	Secondary outcomes include changes from baseline to one-year follow-up in physical inactivity prevalence measured by a modified version of the questions developed by Saltin and Grimby , and in self-rated health measures using the Short-Form 12 , Health Survey , version 2 .
CONCLUSIONS	This trial will contribute to a critical appraisal of the value of fitness testing as part of preventive health checks .
CONCLUSIONS	The conduction in real-life community and general practice structures makes the trial findings applicable and transferable to other municipalities providing support to decision-makers in the development of approaches to increase levels of physical activity and improve health .
BACKGROUND	ClinicalTrials.gov Identifier : NCT02224248 .
BACKGROUND	Registered 8 August 2014 .

###24461665
BACKGROUND	Patients who are critically ill can develop so-called intensive-care unit acquired weakness , which delays rehabilitation .
BACKGROUND	Reduced muscle mass , quality , or both might have a role .
BACKGROUND	The Early Parenteral Nutrition Completing Enteral Nutrition in Adult Critically Ill Patients ( EPaNIC ) trial ( registered with ClinicalTrials.gov , number NCT00512122 ) showed that tolerating macronutrient deficit for 1 week in intensive-care units ( late parenteral nutrition [ PN ] ) accelerated recovery compared with early PN .
BACKGROUND	The role of weakness was unclear .
BACKGROUND	Our aim was to assess whether late PN and early PN differentially affect muscle weakness and autophagic quality control of myofibres .
METHODS	In this prospectively planned subanalysis of the EPaNIC trial , weakness ( MRC sum score ) was assessed in 600 awake , cooperative patients .
METHODS	Skeletal muscle biopsies , harvested from 122 patients 8 days after randomisation and from 20 matched healthy controls , were studied for autophagy and atrophy .
METHODS	We determined the significance of differences with Mann-Whitney U , Median , Kruskal-Wallis , or ( 2 ) ( exact ) tests , as appropriate .
RESULTS	With late PN , 105 ( 34 % ) of 305 patients had weakness on first assessment ( median day 9 post-randomisation ) compared with 127 ( 43 % ) of 295 patients given early PN ( absolute difference -9 % , 95 % CI -16 to -1 ; p = 0030 ) .
RESULTS	Weakness recovered faster with late PN than with early PN ( p = 0021 ) .
RESULTS	Myofibre cross-sectional area was less and density was lower in critically ill patients than in healthy controls , similarly with early PN and late PN .
RESULTS	The LC3 ( microtubule-associated protein light chain 3 ) II to LC3I ratio , related to autophagosome formation , was higher in patients given late PN than early PN ( p = 0026 ) , reaching values almost double those in the healthy control group ( p = 00016 ) , and coinciding with less ubiquitin staining ( p = 0019 ) .
RESULTS	A higher LC3II to LC3I ratio was independently associated with less weakness ( p = 0047 ) .
RESULTS	Expression of mRNA encoding contractile myofibrillary proteins was lower and E3-ligase expression higher in muscle biopsies from patients than in control participants ( p00006 ) , but was unaffected by nutrition .
CONCLUSIONS	Tolerating a substantial macronutrient deficit early during critical illness did not affect muscle wasting , but allowed more efficient activation of autophagic quality control of myofibres and reduced weakness .
BACKGROUND	UZ Leuven , Research Foundation-Flanders , the Flemish Government , and the European Research Council .

###25040039
BACKGROUND	SH2-containing inositol-5 ' - phosphatase 1 ( SHIP1 ) is an endogenous inhibitor of the phosphoinositide-3-kinase pathway that is involved in the activation and chemotaxis of inflammatory cells .
BACKGROUND	AQX-1125 is a first-in-class , oral SHIP1 activator with a novel anti-inflammatory mode of action .
OBJECTIVE	To evaluate the effects of AQX-1125 on airway responses to allergen challenge in mild-to-moderate asthmatic patients .
METHODS	A randomized , double-blind , placebo-controlled , two-way crossover study was performed in 22 steroid-nave mild-to-moderate asthmatics with a documented late-phase response to inhaled allergen ( LAR ) .
METHODS	AQX-1125 ( 450 mg daily ) or placebo was administered orally for 7 days .
METHODS	Allergen challenge was performed on day 6 ( 2 h postdose ) , followed by methacholine challenge ( day 7 ) , and induced sputum collection and fractional exhaled nitric oxide ( FeNO ) .
RESULTS	AQX-1125 significantly attenuated the late-phase response compared with placebo ( FEV1 4-10 h : mean difference 150 mL , 20 % ; P = 0.027 ) and significantly increased the minimum FEV1 during LAR ( mean difference 180 mL ; P = 0.014 ) .
RESULTS	AQX-1125 had no effect on the early-phase response .
RESULTS	AQX-1125 showed a trend in reduction of sputum eosinophils , neutrophils and macrophages although this did not achieve significance as there were only 11 paired samples for analysis .
RESULTS	There was no effect on methacholine responsiveness or FeNO .
RESULTS	Pharmacokinetic data showed AQX-1125 was rapidly absorbed with geometric mean Cmax and AUC0-24 h values of 1417 ng/mL and 16 727 h ng/mL , respectively .
RESULTS	AQX-1125 was well tolerated , but mild GI side-effects ( dyspepsia , nausea and abdominal pain ) were described in 4/22 subjects on active treatment .
RESULTS	These side-effects were mild self-limiting , required no further treatment and did not lead to discontinuation of therapy .
CONCLUSIONS	AQX-1125 , a novel oral SHIP1 activator , significantly reduces the late response to allergen challenge , with a trend to reduce airway inflammation .
CONCLUSIONS	AQX-1125 was safe and well tolerated and merits further investigation in inflammatory disorders .

###24879138
BACKGROUND	Endoscopic submucosal dissection ( ESD ) allows en bloc resection of superficial colorectal tumors regardless of size .
BACKGROUND	However , ESD is technically difficult , hazardous , and time consuming .
BACKGROUND	New devices may help overcome these drawbacks .
BACKGROUND	We focused on traction methods and designed a new traction device , the `` S-O clip . ''
BACKGROUND	Its main advantage is that it allows direct visualization of the cutting line during submucosal dissection .
BACKGROUND	Moreover , it can be used at any location without withdrawing the endoscope .
BACKGROUND	The purpose of this study was to evaluate the efficacy and safety of traction device-assisted ESD for large colorectal tumors using the S-O clip .
METHODS	Between August 2010 and December 2011 , ESD was performed in 70 patients with a superficial colorectal tumor 20 mm in diameter in our department .
METHODS	Patients were randomized into two groups : 27 cases in the S-O clip-assisted ESD group and 23 cases in the conventional ESD group .
METHODS	Included in the analysis were patient 's gender and age , tumor form , size , and location , rate of en bloc resection , procedure time , presence or absence of intraoperative perforation or delayed bleeding , and pathological findings .
METHODS	Subgroup analysis stratified by these factors and multivariate analyses were conducted .
RESULTS	In the S-O clip-assisted ESD group , all 27 tumors were resected en bloc without any complications .
RESULTS	Although a micro perforation occurred in one patient in the conventional ESD group , further surgical treatment was not required .
RESULTS	None of the other 22 cases in the conventional ESD group experienced complications .
RESULTS	The mean procedure time for the S-O clip-assisted ESD group was significantly shorter than for the conventional ESD group ( 37.4 32.6 vs. 67.1 44.1 min , p = 0.03 ) .
RESULTS	No significant between-group differences were found for the other factors .
CONCLUSIONS	Our results demonstrated that S-O clip-assisted ESD is safe and fast for en bloc resection of large superficial colorectal tumors .

###24678612
BACKGROUND	A mosquito repellent has the potential to prevent malaria infection , but there has been few studies demonstrating the effectiveness of combining this strategy with the highly effective long-lasting insecticidal nets ( LLINs ) .
BACKGROUND	This study aimed to determine the effect of combining community-based mosquito repellent with LLINs in the reduction of malaria .
METHODS	A community-based clustered-randomised trial was conducted in 16 rural villages with 1,235 households in southern Ethiopia between September and December of 2008 .
METHODS	The villages were randomly assigned to intervention ( mosquito repellent and LLINs , eight villages ) and control ( LLINs alone , eight villages ) groups .
METHODS	Households in the intervention villages received mosquito repellent ( i.e. , Buzz-Off petroleum jelly , essential oil blend ) applied every evening .
METHODS	The baseline survey was followed by two follow-up surveys , at one month interval .
METHODS	The primary outcome was detection of Plasmodium falciparum , Plasmodium vivax , or both parasites , through microscopic examination of blood slides .
METHODS	Analysis was by intention to treat .
METHODS	Baseline imbalances and clustering at individual , household and village levels were adjusted using a generalized linear mixed model .
RESULTS	3,078 individuals in intervention and 3,004 in control group were enrolled into the study .
RESULTS	Compared with the control arm , the combined use of mosquito repellent and LLINs significantly reduced malaria infection of all types over time [ adjusted Odds Ratio ( aOR ) = 0.66 ; 95 % CI = 0.45-0 .97 ] .
RESULTS	Similarly , a substantial reduction in P. falciparum malaria infection during the follow-up surveys was observed in the intervention group ( aOR = 0.53 , 95 % CI = 0.31-0 .89 ) .
RESULTS	The protective efficacy of using mosquito repellent and LLINs against malaria infection of both P. falciparum/P .
RESULTS	vivax and P. falciparum was 34 % and 47 % , respectively .
CONCLUSIONS	Daily application of mosquito repellent during the evening followed by the use of LLINs during bedtime at community level has significantly reduced malaria infection .
CONCLUSIONS	The finding has strong implication particularly in areas where malaria vectors feed mainly in the evening before bedtime .
BACKGROUND	ClinicalTrials.gov identifier : NCT01160809 .

###24841975
OBJECTIVE	Most patients with acute myeloid leukemia ( AML ) eventually experience relapse .
OBJECTIVE	Relapsed/refractory AML has a dismal prognosis and currently available treatment options are generally ineffective .
OBJECTIVE	The objective of this large , international , randomized clinical trial was to investigate the efficacy of elacytarabine , a novel elaidic acid ester of cytarabine , versus the investigator 's choice of one of seven commonly used AML salvage regimens , including high-dose cytarabine , multiagent chemotherapy , hypomethylating agents , hydroxyurea , and supportive care .
METHODS	A total of 381 patients with relapsed/refractory AML were treated in North America , Europe , and Australia .
METHODS	Investigators selected a control treatment for individual patients before random assignment .
METHODS	The primary end point was overall survival ( OS ) .
RESULTS	There were no significant differences in OS ( 3.5 v 3.3 months ) , response rate ( 23 % v 21 % ) , or relapse-free survival ( 5.1 v 3.7 months ) between the elacytarabine and control arms , respectively .
RESULTS	There was no significant difference in OS among any of the investigator 's choice regimens .
RESULTS	Prolonged survival was only achieved in a few patients in both study arms whose disease responded and who underwent allogeneic stem-cell transplantation .
CONCLUSIONS	Neither elacytarabine nor any of the seven alternative treatment regimens provided clinically meaningful benefit to these patients .
CONCLUSIONS	OS in both study arms and for all treatments was extremely poor .
CONCLUSIONS	Novel agents , novel clinical trial designs , and novel strategies of drug development are all desperately needed for this patient population .

###25771249
BACKGROUND	Modifiable vascular and lifestyle-related risk factors have been associated with dementia risk in observational studies .
BACKGROUND	In the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability ( FINGER ) , a proof-of-concept randomised controlled trial , we aimed to assess a multidomain approach to prevent cognitive decline in at-risk elderly people from the general population .
METHODS	In a double-blind randomised controlled trial we enrolled individuals aged 60-77 years recruited from previous national surveys .
METHODS	Inclusion criteria were CAIDE ( Cardiovascular Risk Factors , Aging and Dementia ) Dementia Risk Score of at least 6 points and cognition at mean level or slightly lower than expected for age .
METHODS	We randomly assigned participants in a 1:1 ratio to a 2 year multidomain intervention ( diet , exercise , cognitive training , vascular risk monitoring ) , or a control group ( general health advice ) .
METHODS	Computer-generated allocation was done in blocks of four ( two individuals randomly allocated to each group ) at each site .
METHODS	Group allocation was not actively disclosed to participants and outcome assessors were masked to group allocation .
METHODS	The primary outcome was change in cognition as measured through comprehensive neuropsychological test battery ( NTB ) Z score .
METHODS	Analysis was by modified intention to treat ( all participants with at least one post-baseline observation ) .
METHODS	This trial is registered at ClinicalTrials.gov , number NCT01041989 .
RESULTS	Between Sept 7 , 2009 , and Nov 24 , 2011 , we screened 2654 individuals and randomly assigned 1260 to the intervention group ( n = 631 ) or control group ( n = 629 ) .
RESULTS	591 ( 94 % ) participants in the intervention group and 599 ( 95 % ) in the control group had at least one post-baseline assessment and were included in the modified intention-to-treat analysis .
RESULTS	Estimated mean change in NTB total Z score at 2 years was 020 ( SE 002 , SD 051 ) in the intervention group and 016 ( 001 , 051 ) in the control group .
RESULTS	Between-group difference in the change of NTB total score per year was 0022 ( 95 % CI 0002-0042 , p = 0030 ) .
RESULTS	153 ( 12 % ) individuals dropped out overall .
RESULTS	Adverse events occurred in 46 ( 7 % ) participants in the intervention group compared with six ( 1 % ) participants in the control group ; the most common adverse event was musculoskeletal pain ( 32 [ 5 % ] individuals for intervention vs no individuals for control ) .
CONCLUSIONS	Findings from this large , long-term , randomised controlled trial suggest that a multidomain intervention could improve or maintain cognitive functioning in at-risk elderly people from the general population .
BACKGROUND	Academy of Finland , La Carita Foundation , Alzheimer Association , Alzheimer 's Research and Prevention Foundation , Juho Vainio Foundation , Novo Nordisk Foundation , Finnish Social Insurance Institution , Ministry of Education and Culture , Salama bint Hamdan Al Nahyan Foundation , Axa Research Fund , EVO funding for University Hospitals of Kuopio , Oulu , and Turku and for Seinjoki Central Hospital and Oulu City Hospital , Swedish Research Council , Swedish Research Council for Health , Working Life and Welfare , and af Jochnick Foundation .

###25502511
BACKGROUND	The central nervous system manifestations in Fabry disease ( FD ) include progressive white matter lesions ( WMLs ) and stroke .
BACKGROUND	Due to progressive microvascular involvement , men and women with FD over 35 years of age develop WMLs .
BACKGROUND	Moreover , the prevalence of stroke has been estimated to be 12 times higher in FD compared with the general population .
BACKGROUND	Enzyme replacement therapy ( ERT ) is available and has shown beneficial effects on renal , cardiac , and peripheral nerve function in FD , but the ERT effect on the progression of WMLs , or the reduction in cerebrovascular events , remains unknown .
METHODS	The WML burden and the effect of agalsidase beta 1 mg/kg biweekly on WML progression were assessed longitudinally in a Phase 4 agalsidase-beta placebo-controlled analysis of untreated and treated FD patients with mild-to-moderate renal involvement ( serum creatinine measurements of 1.2 mg/dl and < 3.0 mg/dl ) .
METHODS	The primary end point was the difference in the number of patients with increased WML burden between the agalsidase beta and placebo groups at the end of treatment .
METHODS	The diameters of the WMLs were determined manually using axial flow-attenuated-inversion-recovery-weighted magnetic resonance imaging ( MRI ) scans taken at baseline and follow-up .
RESULTS	MRI scans from 41 FD patients ( mean age 43.9 , age range 20-68 , 3 females ; n = 25 on ERT , n = 16 on placebo ) were analyzed .
RESULTS	WML burden was present in 63 % of patients at baseline , increased over a mean of 27 months ( range 12-33 months ) follow-up , and correlated with left ventricular hypertrophy ( LVPW ) .
RESULTS	Patients with previous or recent strokes ( n = 11 , 39-68 years ) showed an increase in the number of WMLs ( p = 0.005 ) .
RESULTS	A greater proportion of younger patients ( 50 years ) on ERT ( n = 18 ) had stable WML burden compared with younger patients in the placebo group ( n = 13 ) : 44 % ( 8 of 18 ) versus 31 % ( 4 of 13 ) , p = 0.014 .
RESULTS	The number needed to treat was 8 .
CONCLUSIONS	This FD patient cohort , with mild-to-moderate renal involvement , had a significant WML burden and high inter-individual variability associated with the degree of LVPW but not the degree of kidney dysfunction .
CONCLUSIONS	These advanced patients with increased LVPW and stroke evidence may have had a higher cerebrovascular risk .
CONCLUSIONS	The WML burden in patients on ERT was more likely to remain stable , compared with patients on placebo .
CONCLUSIONS	Thus , ERT may reduce the progression of vascular disease , even in advanced FD patients , suggesting that early treatment may stabilize WML progression and stroke risk .

###24352294
OBJECTIVE	The extent to which alterations in energy expenditure ( EE ) in response to sleep restriction contribute to the short sleep-obesity relationship is not clearly defined .
OBJECTIVE	Short sleep may induce changes in resting metabolic rate ( RMR ) , thermic effect of food ( TEF ) and postprandial substrate oxidation .
METHODS	Ten females ( age and body mass index : 22-43 years and 23.4-28kgm ( -2 ) ) completed a randomized , crossover study assessing the effects of short ( 4h per night ) and habitual ( 8h per night ) sleep duration on fasting and postprandial RMR and respiratory quotient ( RQ ) .
METHODS	Measurements were taken after three nights using whole-room indirect calorimetry .
METHODS	The TEF was assessed over a 6-h period following consumption of a high-fat liquid meal .
RESULTS	Short versus habitual sleep did not affect RMR ( 1.010.05 and 0.970.04 kcalmin ( -1 ) ; P = 0.23 ) .
RESULTS	Fasting RQ was significantly lower after short versus habitual sleep ( 0.840.01 and 0.880.01 ; P = 0.028 ) .
RESULTS	Postprandial EE ( short : 1.130.04 and habitual : 1.100.04 , P = 0.09 ) and RQ ( short : 0.880.01 and habitual : 0.880.01 , P = 0.50 ) after the high-fat meal were not different between conditions .
RESULTS	TEF was similar between conditions ( 0.240.02 kcalmin ( -1 ) in both ; P = 0.98 ) , as was the ~ 6-h incremental area under the curve ( 1.160.10 and 1.170.09 kcalmin ( -1 ) 356min after short and habitual sleep , respectively ; P = 0.92 ) .
CONCLUSIONS	Current findings observed in non-obese healthy premenopausal women do not support the hypothesis that alterations in TEF and postprandial substrate oxidation are major contributors to the higher rate of obesity observed in short sleepers .
CONCLUSIONS	In exploring a role of sleep duration on EE , research should focus on potential alterations in physical activity to explain the increased obesity risk in short sleepers .

###24645871
BACKGROUND	One form of meditation intervention , the integrative body-mind training ( IBMT ) has been shown to improve attention , reduce stress and change self-reports of mood .
BACKGROUND	In this paper we examine whether short-term IBMT can improve performance related to creativity and determine the role that mood may play in such improvement .
METHODS	Forty Chinese undergraduates were randomly assigned to short-term IBMT group or a relaxation training ( RT ) control group .
METHODS	Mood and creativity performance were assessed by the Positive and Negative Affect Schedule ( PANAS ) and Torrance Tests of Creative Thinking ( TTCT ) questionnaire respectively .
RESULTS	As predicted , the results indicated that short-term ( 30 min per day for 7 days ) IBMT improved creativity performance on the divergent thinking task , and yielded better emotional regulation than RT. .
RESULTS	In addition , cross-lagged analysis indicated that both positive and negative affect may influence creativity in IBMT group ( not RT group ) .
CONCLUSIONS	Our results suggested that emotion-related creativity-promoting mechanism may be attributed to short-term meditation .

###24568260
METHODS	Randomized clinical trial .
OBJECTIVE	To determine the effects of trigger point dry needling ( TrPDN ) on neck pain , widespread pressure pain sensitivity , and cervical range of motion in patients with acute mechanical neck pain and active trigger points in the upper trapezius muscle .
BACKGROUND	TrPDN seems to be effective for decreasing pain in individuals with upper-quadrant pain syndromes .
BACKGROUND	Potential effects of TrPDN for decreasing pain and sensitization in individuals with acute mechanical neck pain are needed .
BACKGROUND	Methods Seventeen patients ( 53 % female ) were randomly assigned to 1 of 2 groups : a single session of TrPDN or no intervention ( waiting list ) .
BACKGROUND	Pressure pain thresholds over the C5-6 zygapophyseal joint , second metacarpal , and tibialis anterior muscle ; neck pain intensity ; and cervical spine range-of-motion data were collected at baseline ( pretreatment ) and 10 minutes and 1 week after the intervention by an assessor blinded to the treatment allocation of the patient .
BACKGROUND	Mixed-model analyses of variance were used to examine the effects of treatment on each outcome variable .
RESULTS	Patients treated with 1 session of TrPDN experienced greater decreases in neck pain , greater increases in pressure pain threshold , and higher increases in cervical range of motion than those who did not receive an intervention at both 10 minutes and 1 week after the intervention ( P < .01 for all comparisons ) .
RESULTS	Between-group effect sizes were medium to large immediately after the TrPDN session ( standardized mean score differences greater than 0.56 ) and large at the 1-week follow-up ( standardized mean score differences greater than 1.34 ) .
CONCLUSIONS	The results of the current randomized clinical trial suggest that a single session of TrPDN may decrease neck pain intensity and widespread pressure pain sensitivity , and also increase active cervical range of motion , in patients with acute mechanical neck pain .
CONCLUSIONS	Changes in pain , pressure pain threshold , and cervical range of motion surpassed their respective minimal detectable change values , supporting clinically relevant treatment effects .
CONCLUSIONS	Level of Evidence Therapy , level 1b - .

###24279460
OBJECTIVE	To evaluate the applicability of single-incision laparoscopic ovariectomy ( SILOVE ) in cats using a single-incision laparoscopic port ( SILP ) ; to compare surgical time , complications , and postoperative pain after SILOVE using a LigaSure ( SILOVE-LS ) or extracorporeal suture ( SILOVE-ECS ) , and open ovariectomy ( open-OVE ) .
METHODS	Randomized , blinded , prospective study .
METHODS	Healthy , domestic female cats ( n = 24 ) .
METHODS	Cats underwent physical examination , packed cell volume , total solids and blood urea nitrogen analysis .
METHODS	Cats were randomly assigned to 1 of 3 groups : SILOVE-LS ( n = 8 ) , SILOVE-ECS ( 8 ) or open-OVE ( 8 ) .
METHODS	Surgical time , complications , and postoperative pain scores were recorded .
RESULTS	Single-incision laparoscopic ovariectomy was successful in ( n = 8 ) SILOVE-LS cats and ( n = 5 ) SILOVE-ECS cats .
RESULTS	Surgical time was significantly longer for the SILOVE-ECS group compared with the SILOVE-LS ( P < .0001 ) and open-OVE ( P < .0001 ) groups , which were not different ( P = .55 ) .
RESULTS	Complications were more frequent in the SILOVE-ECS group and removal of the SILP was required to complete ovariectomy in 3 cats .
RESULTS	Cumulative 4-hour pain scores were not different between groups .
CONCLUSIONS	Single-incision laparoscopic ovariectomy using a SILP is a feasible method for OVE in cats .
CONCLUSIONS	Single-incision laparoscopic ovariectomy using an extracorporeal suture is more time consuming and associated with more complications than either the SILOVE-LS or open-OVE methods .

###25307414
BACKGROUND	Indacaterol/glycopyrronium ( IND/GLY ) is a once-daily inhaled fixed-dose combination of indacaterol ( IND ) , a long-acting 2-adrenergic agonist ( LABA ) , and glycopyrronium ( GLY ) , a long-acting muscarinic antagonist ( LAMA ) for use as maintenance treatment to relieve symptoms of chronic obstructive pulmonary disease ( COPD ) in adults .
OBJECTIVE	To determine the economic benefits of IND/GLY compared with the free combination of indacaterol and glycopyrronium ( IND+GLY ) , and with the fixed-dose combination of salmeterol/fluticasone ( SFC ) , in a moderate-to-severe COPD population with low-exacerbation risk .
OBJECTIVE	The model-based analysis extrapolated results up to lifetime time horizon and calculated costs per quality-adjusted life year .
METHODS	Assuming equal efficacy , a cost-minimisation analysis compared IND/GLY vs IND+GLY using model inputs from the double-blind , randomised SHINE trial .
METHODS	The double-blind , randomised ILLUMINATE and TORCH trials were used to analyse cost-effectiveness versus SFC. To consider ICS-related pneumonia events , published odds ratio comparing an ICS-exposed group to a control group of COPD patients was used .
METHODS	Direct and indirect drug costs as well as drug acquisition costs ( in Swedish Krona [ SEK ] ) were derived from published Swedish sources .
METHODS	Cost and effects were discounted with 3 % .
METHODS	Uncertainty was assessed by one-way and probabilistic sensitivity analyses ( PSA ) .
RESULTS	IND/GLY was cost-saving vs IND+GLY with incremental savings of SEK ( EUR ) 768 ( 85 ) , and 3309 ( 368 ) per patient over one and five years .
RESULTS	IND/GLY was found to be less costly and more effective compared to SFC with cost savings of SEK ( EUR ) 2744 ( 303 ) , 8854 ( 976 ) , 13,938 ( 1536 ) , 27,495 ( 3031 ) and 43,033 ( 4744 ) over one , three , five , ten years and lifetime .
RESULTS	The PSA indicated that all iterations produced dominant results for IND/GLY .
CONCLUSIONS	IND/GLY is cost-minimising vs IND+GLY and dominates SFC in the maintenance treatment of COPD patients in Sweden .
CONCLUSIONS	Encouraging dual bronchodilator therapy over an ICS-containing combination results in lower total costs and better outcomes compared to combination therapy including fluticasone in moderate-to-severe COPD patients with low exacerbation risk .

###25251893
OBJECTIVE	Although the combination of midazolam-meperidine has been widely used as a sedation regimen for colonoscopy , its residual effect which is longer than the duration of a colonoscopy procedure can delay patient recovery and discharge .
OBJECTIVE	Remifentanil , an ultra-short-acting opioid , has a very brief duration of action .
OBJECTIVE	We hypothesized that using remifentanil alone for colonoscopy would provide shorter recovery time compared with the midazolam-meperidine combination .
METHODS	Time to achieve Aldrete score = 10 was determined and compared in patients who were randomly allocated to receive remifentanil alone ( group-R , n = 27 ) or a midazolam-meperidine combination ( group-MM , n = 27 ) for colonoscopy .
METHODS	Intergroup differences in sedation , recall analgesia , cardio-respiratory profiles , and satisfaction of patient and endoscopist were also determined during and after colonoscopy .
RESULTS	Group-R showed a significantly shorter recovery time than group-MM ( median [ 25-75 % ] , 0 [ 0-10 ] vs 30 [ 15-30 ] min , P < 0.001 ) .
RESULTS	Group-R showed significantly higher bispectral-index values during colonoscopy ( 92 [ 85-96 ] vs 84 [ 80-87 ] , P = 0.001 ) ; a higher incidence of recall of explanations given during and after colonoscopy ( 100 vs 48 % and 96 vs 52 % , both P < 0.001 ) ; and a lower distress score ( visual analog scale 30/100 vs 37/100mm , P = 0.002 ) , than did group-MM .
RESULTS	Neither extent of pain , incidence of hemodynamic instability nor incidence of respiratory depression differed between the groups .
CONCLUSIONS	Remifentanil for colonoscopy afforded faster recovery compared to midazolam-meperidine combination .
CONCLUSIONS	It also provided greater patient-endoscopist communication and satisfaction with comparable patient analgesia and cardiorespiratory profile during colonoscopy .

###25982972
OBJECTIVE	To define the role of increased fundus autofluorescence ( FAF ) , a surrogate for lipofuscin content , as a risk factor for progression of geographic atrophy ( GA ) .
METHODS	Prospective natural history cohort study , the GAIN ( Characterization of geographic atrophy progression in patients with age-related macular degeneration ) .
METHODS	setting : Single-center study conducted in Barcelona , Spain .
METHODS	After screening of 211 patients , 109 eyes of 82 patients with GA secondary to age-related macular degeneration and a minimum follow-up of 6 months were included .
METHODS	Lipofuscin content was classified independently by 2 masked observers according to FAF patterns described previously .
METHODS	Bivariate , stratified , and multivariable analyses were used to explore the associations between GA growth and independent variables .
METHODS	Mediation analysis was used to evaluate the contribution of FAF patterns to GA progression .
RESULTS	Progression of GA in mm ( 2 ) / year as measured with FAF .
RESULTS	Median follow-up was 18 months ( range , 6-42 ) .
RESULTS	Median GA growth was 1.61 mm ( 2 ) / year .
RESULTS	FAF , baseline area of atrophy , and time of follow-up were independently associated with GA progression ( P < .004 ) .
RESULTS	FAF patterns and baseline area of atrophy were strongly associated ( P < .0001 ) , suggesting potential confounding .
RESULTS	Mediation analysis suggested that most of the effect of FAF patterns on GA growth was actually caused by baseline area of atrophy .
CONCLUSIONS	FAF patterns , baseline area of atrophy , and time of follow-up were associated with GA progression .
CONCLUSIONS	However , FAF patterns seem to be a consequence ( not a cause ) of enlarging atrophy and their effect on GA progression seems mostly driven by baseline area of atrophy .

###24866597
OBJECTIVE	Magnetic resonance imaging guided biopsy is increasingly performed to diagnose prostate cancer .
OBJECTIVE	However , there is a lack of well controlled , prospective trials to support this treatment method .
OBJECTIVE	We prospectively compared magnetic resonance imaging guided in-bore biopsy with standard systematic transrectal ultrasound guided biopsy in biopsy nave men with increased prostate specific antigen .
METHODS	We performed a prospective study in 132 biopsy nave men with increased prostate specific antigen ( greater than 4 ng/ml ) .
METHODS	After 3 Tesla functional multiparametric magnetic resonance imaging patients were referred for magnetic resonance imaging guided in-bore biopsy of prostate lesions ( maximum 3 ) followed by standard systematic transrectal ultrasound guided biopsy ( 12 cores ) .
METHODS	We analyzed the detection rates of prostate cancer and significant prostate cancer ( greater than 5 mm total cancer length or any Gleason pattern greater than 3 ) .
RESULTS	A total of 128 patients with a mean SD age of 66.1 8.1 years metall study requirements .
RESULTS	Median prostate specific antigen was 6.7 ng/ml ( IQR 5.1-9 .0 ) .
RESULTS	Transrectal ultrasound and magnetic resonance imaging guided biopsies provided the same 53.1 % detection rate , including 79.4 % and 85.3 % , respectively , for significant prostate cancer .
RESULTS	Magnetic resonance imaging and transrectal ultrasound guided biopsies missed 7.8 % and 9.4 % of clinically significant prostate cancers , respectively .
RESULTS	Magnetic resonance imaging biopsy required significantly fewer cores and revealed a higher percent of cancer involvement per biopsy core ( each p < 0.01 ) .
RESULTS	Combining the 2 methods provided a 60.9 % detection rate with an 82.1 % rate for significant prostate cancer .
CONCLUSIONS	Magnetic resonance imaging guided in-bore and systematic transrectal ultrasound guided biopsies achieved equally high detection rates inbiopsy nave patients with increased prostate specific antigen .
CONCLUSIONS	Magnetic resonance imaging guided in-bore biopsies required significantly fewer cores and revealed a significantly higher percent of cancer involvement per biopsy core .

###24972748
OBJECTIVE	Ulcerative colitis ( UC ) is a chronic inflammatory bowel disease .
OBJECTIVE	The probiotic bacterium Escherichia coli Nissle 1917 ( EcN ) has been used to maintain and induce clinical remission in UC .
OBJECTIVE	Our aim was to test the effect of Ciprofloxacin and/or orally administered EcN as add-on to conventional therapies in patients with active UC .
METHODS	Our single center double-blinded randomized placebo controlled study included patients with a Colitis Activity Index ( CAI ) score of at least 6 .
METHODS	Patients were randomized to Ciprofloxacin or placebo for 1week followed by EcN or placebo for 7weeks .
METHODS	All 4 treatments were given as add-on treatments .
RESULTS	One hundred subjects with active UC were recruited .
RESULTS	In the per-protocol analysis we , surprisingly , found that in the group receiving placebo/EcN fewer patients , 54 % , reached remission compared to the group receiving placebo/placebo , 89 % , p < 0.05 .
RESULTS	Among patients treated with Cipro/placebo and Cipro/EcN , 78 % and 66 % reached remission , respectively .
RESULTS	Furthermore , the group receiving placebo/EcN had the largest number of withdrawals , 11 of 25 ( 44 % ) , compared to 15 of 75 ( 20 % ) in any of the other groups , p < 0.05 .
RESULTS	Indication of lack of mucosal healing was found in the group treated with placebo/Nissle , since only 4 ( 29 % ) of the 14 patients , who completed the study , reported no blood in stools at week 12 ( p < 0.02 ) , compared to 63 % , 67 % and 65 % in groups treated with Cipro/Nissle , Cipro/placebo and placebo/placebo , respectively .
CONCLUSIONS	Our data suggest that there is no benefit in the use of E. coli Nissle as an add-on treatment to conventional therapies for active ulcerative colitis .
CONCLUSIONS	Furthermore , treatment with E. coli Nissle without a previous antibiotic cure resulted in fewer patients reaching clinical remission .

###26054865
OBJECTIVE	Perirectal spacing , whereby biomaterials are placed between the prostate and rectum , shows promise in reducing rectal dose during prostate cancer radiation therapy .
OBJECTIVE	A prospective multicenter randomized controlled pivotal trial was performed to assess outcomes following absorbable spacer ( SpaceOAR system ) implantation .
METHODS	Overall , 222 patients with clinical stage T1 or T2 prostate cancer underwent computed tomography ( CT ) and magnetic resonance imaging ( MRI ) scans for treatment planning , followed with fiducial marker placement , and were randomized to receive spacer injection or no injection ( control ) .
METHODS	Patients received postprocedure CT and MRI planning scans and underwent image guided intensity modulated radiation therapy ( 79.2 Gy in 1.8-Gy fractions ) .
METHODS	Spacer safety and impact on rectal irradiation , toxicity , and quality of life were assessed throughout 15months .
RESULTS	Spacer application was rated as `` easy '' or `` very easy '' 98.7 % of the time , with a 99 % hydrogel placement success rate .
RESULTS	Perirectal spaces were 12.63.9 mm and 1.62.0 mm in the spacer and control groups , respectively .
RESULTS	There were no device-related adverse events , rectal perforations , serious bleeding , or infections within either group .
RESULTS	Pre-to postspacer plans had a significant reduction in mean rectal V70 ( 12.4 % to 3.3 % , P < .0001 ) .
RESULTS	Overall acute rectal adverse event rates were similar between groups , with fewer spacer patients experiencing rectal pain ( P = .02 ) .
RESULTS	A significant reduction in late ( 3-15months ) rectal toxicity severity in the spacer group was observed ( P = .04 ) , with a 2.0 % and 7.0 % late rectal toxicity incidence in the spacer and control groups , respectively .
RESULTS	There was no late rectal toxicity greater than grade 1 in the spacer group .
RESULTS	At 15months 11.6 % and 21.4 % of spacer and control patients , respectively , experienced 10-point declines in bowel quality of life .
RESULTS	MRI scans at 12months verified spacer absorption .
CONCLUSIONS	Spacer application was well tolerated .
CONCLUSIONS	Increased perirectal space reduced rectal irradiation , reduced rectal toxicity severity , and decreased rates of patients experiencing declines in bowel quality of life .
CONCLUSIONS	The spacer appears to be an effective tool , potentially enabling advanced prostate RT protocols .

###24866862
OBJECTIVE	In older adults reduced mobility is common and is an independent risk factor for morbidity , hospitalization , disability , and mortality .
OBJECTIVE	Limited evidence suggests that physical activity may help prevent mobility disability ; however , there are no definitive clinical trials examining whether physical activity prevents or delays mobility disability .
OBJECTIVE	To test the hypothesis that a long-term structured physical activity program is more effective than a health education program ( also referred to as a successful aging program ) in reducing the risk of major mobility disability .
METHODS	The Lifestyle Interventions and Independence for Elders ( LIFE ) study was a multicenter , randomized trial that enrolled participants between February 2010 and December 2011 , who participated for an average of 2.6 years .
METHODS	Follow-up ended in December 2013 .
METHODS	Outcome assessors were blinded to the intervention assignment .
METHODS	Participants were recruited from urban , suburban , and rural communities at 8 centers throughout the United States .
METHODS	We randomized a volunteer sample of 1635 sedentary men and women aged 70 to 89 years who had physical limitations , defined as a score on the Short Physical Performance Battery of 9 or below , but were able to walk 400 m.
METHODS	Participants were randomized to a structured , moderate-intensity physical activity program ( n = 818 ) conducted in a center ( twice/wk ) and at home ( 3-4 times/wk ) that included aerobic , resistance , and flexibility training activities or to a health education program ( n = 817 ) consisting of workshops on topics relevant to older adults and upper extremity stretching exercises .
METHODS	The primary outcome was major mobility disability objectively defined by loss of ability to walk 400 m.
RESULTS	Incident major mobility disability occurred in 30.1 % ( 246 participants ) of the physical activity group and 35.5 % ( 290 participants ) of the health education group ( hazard ratio [ HR ] , 0.82 [ 95 % CI , 0.69-0 .98 ] , P = .03 ) .
RESULTS	Persistent mobility disability was experienced by 120 participants ( 14.7 % ) in the physical activity group and 162 participants ( 19.8 % ) in the health education group ( HR , 0.72 [ 95 % CI , 0.57-0 .91 ] ; P = .006 ) .
RESULTS	Serious adverse events were reported by 404 participants ( 49.4 % ) in the physical activity group and 373 participants ( 45.7 % ) in the health education group ( risk ratio , 1.08 [ 95 % CI , 0.98-1 .20 ] ) .
CONCLUSIONS	A structured , moderate-intensity physical activity program compared with a health education program reduced major mobility disability over 2.6 years among older adults at risk for disability .
CONCLUSIONS	These findings suggest mobility benefit from such a program in vulnerable older adults .
BACKGROUND	clinicaltrials.gov Identifier : NCT01072500 .

###24906836
OBJECTIVE	This study was conducted to assess the effectiveness of combinations of Ayurvedic drugs in alleviating the toxicity of chemotherapy and improving the quality of life of cancer patients .
OBJECTIVE	The following was the research question : Can Ayurvedic drugs be used to alleviate the side effects of chemotherapy and improve the quality of life of cancer patients ?
METHODS	Random patients with malignancies of different tissues , grades , and stages were divided into two groups according to their treatment modality .
METHODS	Group 1 consisted of 15 patients treated with six cycles of chemotherapy alone and who did not receive any Ayurvedic drugs ( control group ) .
METHODS	Group 2 consisted of patients ( divided into three arms ) who received Ayurvedic drugs during chemotherapy and after chemotherapy .
METHODS	Nineteen patients in arm 1 received the Ayurvedic drugs Mauktikyukta Kamdudha ( MKD ) and Mauktikyukta Praval Panchamruta ( MPP ) along with a full course of chemotherapy .
METHODS	Fifteen patients in arm 2 received the same Ayurvedic treatment , but the treatment was started after completing the sixth cycle of chemotherapy .
METHODS	Eighteen patients in arm 3 received the Suvarnabhasmadi formulation ( SBD ) in addition to MKD and MPP after completing the sixth cycle of chemotherapy .
METHODS	Treatment was given for 16 weeks in all three arms .
METHODS	Patients from both groups were observed for a period of 6 months .
METHODS	The assessment criteria depended on Common Toxicity Criteria ( CTC designed by NIH and NCI ) : haemogram ; weight ; physical examination including Quality of Life Questionnaire ( QLQ designed by the European Organization of Research and Treatment of Cancer ( EORTC ) ) for functional , symptom and global scores ; and Karnofsky score for assessment of general well-being and activities of daily life .
METHODS	ECOG ( Eastern Cooperation Oncology Group ) score was also additionally included for assessment of symptoms .
RESULTS	From amongst the symptomatic criteria , there was significant improvement in all the three arms compared with the control group in nausea , loss of appetite , constipation , and fatigue .
RESULTS	There was significant improvement in the Karnofsky score and global score of the QLQ , which in fact incorporate symptomatic criteria , general condition , functional ability and disease-related symptoms .
RESULTS	These significant differences were observed in group 2 ( arms 1 , 2 , 3 ) in comparison with group 1 ( control ) , in spite of the fact that in arms 2 and 3 , the Ayurvedic treatment was started after completion of chemotherapy .
RESULTS	The haemogram did not show a significant difference between the control and the three arms of group 2 .
CONCLUSIONS	Adjunct treatment with herbo-mineral and metallic Ayurvedic drugs appears to have a significant effect on reducing the toxic side effects of chemotherapy drugs in cancer patients .
CONCLUSIONS	Our preliminary data suggests that Ayurvedic treatment should be given simultaneously from the beginning of chemotherapy to have the desired effect .
CONCLUSIONS	However , there is a need to extend this work by conducting a well-planned two-armed study on cancer patients with defined cancer sites with selected Ayurvedic drug combinations , and observing the patients for a longer period of time to confirm the effectiveness of Ayurvedic drugs in reducing the side effects of chemotherapy .

###24805248
BACKGROUND	There is no widely accepted treatment for non-alcoholic fatty liver disease ( NAFLD ) or its advanced form , non-alcoholic steatohepatitis ( NASH ) .
METHODS	We administered rosuvastatin ( 10 mg/day ) for 1 year in patients with metabolic syndrome ( MetS ) , NASH on liver biopsy and dyslipidaemia ( but without diabetes or arterial hypertension ) .
METHODS	Patients also received lifestyle advice .
RESULTS	We report preliminary results for 6 patients .
RESULTS	The second biopsy ( at the end of the study ) showed complete resolution of NASH in 5 patients , while the 6 ( th ) , which had no improvement , developed arterial hypertension and substantial rise in triglyceride levels during the study .
RESULTS	We suspect alcohol abuse despite advice to abstain .
RESULTS	Serum alanine transaminase ( ALT ) and aspartate transaminase ( AST ) activities were reduced by 76 and 61 % , respectively ( p < 0.001 for both ) , during treatment , while - glutamyl transpeptidase ( - GT ) , and alkaline phosphatase ( AP ) showed smaller non significant reductions .
RESULTS	Fasting plasma glucose and glycated haemoglobin ( HbA1c ) were significantly reduced ( p < 0.05 ) .
RESULTS	Lipid values were totally normalised and liver ultrasonography showed a complete resolution of NASH in 5 patients .
RESULTS	Body mass index and waist circumference remained unchanged during the study .
RESULTS	Thus , changes in liver pathology and function should be attributed to treatment with rosuvastatin .
RESULTS	A substantial limitation of the study is the small number of patients .
CONCLUSIONS	These preliminary findings suggest that rosuvastatin could ameliorate NASH within a year of treatment in MetS patients with dyslipidaemia .

###25602889
OBJECTIVE	We tested whether a structural intervention combining savings-led microfinance and HIV prevention components would achieve enhanced reductions in sexual risk among women engaging in street-based sex work in Ulaanbaatar , Mongolia , compared with an HIV prevention intervention alone .
METHODS	Between November 2011 and August 2012 , we randomized 107 eligible women who completed baseline assessments to either a 4-session HIV sexual risk reduction intervention ( HIVSRR ) alone ( n = 50 ) or a 34-session HIVSRR plus a savings-led microfinance intervention ( n = 57 ) .
METHODS	At 3 - and 6-month follow-up assessments , participants reported unprotected acts of vaginal intercourse with paying partners and number of paying partners with whom they engaged in sexual intercourse in the previous 90 days .
METHODS	Using Poisson and zero-inflated Poisson model regressions , we examined the effects of assignment to treatment versus control condition on outcomes .
RESULTS	At 6-month follow-up , the HIVSRR plus microfinance participants reported significantly fewer paying sexual partners and were more likely to report zero unprotected vaginal sex acts with paying sexual partners .
CONCLUSIONS	Findings advance the HIV prevention repertoire for women , demonstrating that risk reduction may be achieved through a structural intervention that relies on asset building , including savings , and alternatives to income from sex work .

###25257974
OBJECTIVE	This article describes the rationale , design and methodology of the Building research initiative group : chronic illness management and adherence in transplantation ( BRIGHT ) study .
OBJECTIVE	This study of heart transplant patients will : ( 1 ) describe practice patterns relating to chronic illness management ; ( 2 ) assess prevalence and variability of non-adherence to the treatment regimen ; ( 3 ) determine the multi-level factors related to immunosuppressive medication non-adherence .
BACKGROUND	The unaltered long-term prognosis after heart transplantation underscores an urgent need to identify and improve factors related to survival outcomes .
BACKGROUND	The healthcare system ( e.g. level of chronic illness management implemented ) and patient self-management are major drivers of outcome improvement .
METHODS	The study uses a survey design in 40 heart transplant centres covering 11 countries in four continents .
METHODS	Theoretical frameworks informed variable selection , which are measured by established and investigator-developed instruments .
METHODS	Heart transplant recipients , outpatient clinicians and programme 's directors complete a survey .
METHODS	A staged convenience sampling strategy is implemented in heart transplant centres , countries and continents .
METHODS	Depending on the centre 's size , a random sample of 25-60 patients is selected ( N estimated 1680 heart transplant recipients ) .
METHODS	Five randomly selected clinicians and the medical director from each centre will be invited to participate .
CONCLUSIONS	This is the first multi-centre , multi-continental study examining healthcare system and heart transplant centres chronic illness management practice patterns and potential correlates of immunosuppressive medication non-adherence .
CONCLUSIONS	The knowledge gained will inform clinicians , researchers and healthcare policy makers at which level ( s ) interventions need to be implemented to improve long-term outcomes for transplant recipients .

###24641585
BACKGROUND	Increased body mass index and weight gain are risk factors for psoriasis , and the prevalence of obesity in patients with psoriasis is higher than in the general population .
BACKGROUND	Limited data exist regarding the role of diet in psoriasis .
OBJECTIVE	To assess the impact of a dietary intervention combined with physical exercise for weight loss on improving psoriasis in overweight or obese patients .
METHODS	This study included 303 overweight or obese patients with moderate-to-severe chronic plaque psoriasis who did not achieve clearance after 4 weeks of continuous systemic treatment .
METHODS	They were randomized to receive either a 20-week quantitative and qualitative dietary plan associated with physical exercise for weight loss or simple informative counselling at baseline about the utility of weight loss for clinical control of psoriatic disease .
METHODS	The main outcome was any reduction of the Psoriasis Area and Severity Index ( PASI ) from baseline to week 20 .
RESULTS	Intention-to-treat analysis showed a median PASI reduction of 48 % ( 95 % confidence interval 33.3-58 .3 % ) in the dietary intervention arm and 25.5 % ( 95 % confidence interval 18.2-33 .3 % ) in the information-only arm ( P = 0.02 ) .
RESULTS	Among secondary outcomes , PASI score reduction of 50 % significantly differed between study arms ( 49.7 % with dietary intervention vs. 34.2 % with information only , P = 0.006 ) .
RESULTS	The weight-loss target ( a 5 % reduction from baseline ) was reached by 29.8 % of patients in the dietary intervention arm compared with 14.5 % in the information-only arm ( P = 0.001 ) .
CONCLUSIONS	A 20-week dietetic intervention associated with increased physical exercise reduced psoriasis severity in systemically treated overweight or obese patients with active psoriasis .

###25431865
BACKGROUND	According to the results of the international study Relapsed AML 2001/01 response was better after re-induction with L-DNR/FLAG ( liposomal daunorubicin , fludarabine , cytarabine , G-CSF ) compared to FLAG only but survival rate was not improved .
BACKGROUND	However , the findings might be group-specific .
METHODS	Patient characteristics , actual therapy given and long-term course of the disease in 155 pediatric patients ( including non-randomized ) with first relapse and 10 primary nonresponders treated in Germany were analyzed .
RESULTS	Overall 4-year survival rates after relapse were similar in the 2 treatment groups L-DNR/FLAG and FLAG ( 0.43 0.05 vs. 0.47 0.06 , p ( log-rank ) = 0.47 ) .
RESULTS	The rate of randomization was low ( 65 % ) and 5 % of the 101 randomized patients changed the treatment arm .
RESULTS	Therefore , induction was based in 40 % patients on an individual decision with preference for L-DNR/FLAG .
RESULTS	There were less patients with favorable cytogenetics and morphology in the L-DNR/FLAG-group ( p < 0.04 ) .
RESULTS	Response to the first re-induction course at day 28 tended to be more unfavorable with FLAG only .
RESULTS	In this patient group protocol intensifications were more frequent as compared to the L-DNR/FLAG-group ( p = 0.07 ) , and late CR could be achieved after intensification in 9/18 poor responding patients .
CONCLUSIONS	The initial selection bias of relapse patients with unfavorable risk factors to the disadvantage of the L-DNR/FLAG-group and the more drug - and time-intensive treatment after 1 ( st ) re-induction given in the FLAG-group may have nullified the initial beneficial effect of L-DNR containing re-induction therapy and led to similar and relatively favorable survival rates in both treatment groups in Germany .

###25572630
OBJECTIVE	Vitamin D insufficiency drives secondary hyperparathyroidism ( SHPT ) and is associated with increased cardiovascular mortality in patients with chronic kidney disease ( CKD ) .
OBJECTIVE	SHPT is poorly addressed by current vitamin D repletion options .
OBJECTIVE	The present study evaluated a novel investigational vitamin D repletion therapy : a modified-release ( MR ) formulation of calcifediol designed to raise serum 25-hydroxyvitamin D in a gradual manner to minimize the induction of CYP24 and , thereby , improve the SHPT control .
METHODS	This randomized , double-blind , placebo-controlled trial evaluated MR calcifediol in CKD subjects ( n = 78 ) with plasma intact parathyroid hormone ( iPTH ) > 70 pg/ml and serum total 25-hydroxyvitamin D < 30 ng/ml .
METHODS	Subjects received daily treatment for six weeks with oral MR calcifediol ( 30 , 60 or 90 g ) or a placebo .
RESULTS	More than 90 % of subjects treated with MR calcifediol achieved serum 25-hydroxyvitamin D levels 30 ng/ml versus 3 % of subjects treated with placebo ( p < 0.0001 ) .
RESULTS	Mean plasma iPTH decreased from baseline ( 140.3 pg/ml ) by 20.9 6.2 % ( SE ) , 32.8 5.7 and 39.3 4.3 % in the 30 , 60 and 90 g dose groups , respectively , and increased 17.2 7.8 % in the pooled placebo group ( p < 0.005 ) .
RESULTS	No clinically significant safety concerns arose during MR calcifediol treatment .
CONCLUSIONS	Oral MR calcifediol appears safe and highly effective in treating SHPT associated with vitamin D insufficiency in CKD .

###25315887
OBJECTIVE	Chronic autoimmune thyroiditis ( CAT ) ( chronic lymphocytic thyroiditis-Hashimoto 's thyroiditis ) , which is the most common inflammatory disorder of the thyroid gland , causes hypothyroidism .
OBJECTIVE	Ultrasound elastography is a newly developed sonographic technique that provides an estimation of tissue elasticity by measuring the degree of tissue displacement under the application of an external force .
OBJECTIVE	In this study , our aim was to evaluate the accuracy of strain index ratio with real-time ultrasound elastography and to calculate the cut-off point for the diagnosis of CAT .
OBJECTIVE	Our aim was also to lead further studies on other pathological changes such as lymphoma , malign nodules etc. based on CAT by using this cut-off point .
OBJECTIVE	The gains from this study and further studies will assist clinical diagnoses and follow-up .
METHODS	Aplio 500 ultrasound machine ( Toshiba Medical Systems Co. Ltd , Otawara , Japan ) with linear 4.8-11 .0 MHz transducers and elastography software was used .
METHODS	Routine B-mode ( dimensions and parenchymal echogenicity ) ultrasound evaluation was performed prior to the ultrasound elastography .
RESULTS	A total of 31 randomized patients ( 3 males , 28 females ) with a mean age of 39.1310.16 years ( range , 16-58 years ) with CAT and 21 healthy controls ( 6 males , 15 females ) with mean age of 34.6716.31 years ( range , 14-81 years ) were prospectively examined .
RESULTS	The mean values of thyroid-stimulating hormone ( TSH ; normal TSH value is 0.27-4 .20 IUml ( -1 ) ) and anti-thyroid peroxidase ( anti-TPO ; normal anti-TPO value is 0-34IUml ( -1 ) ) were 3.402.70 and 373.66148.94 IUml ( -1 ) , respectively .
RESULTS	No correlation was detected between serum TSH and thyroid tissue strain index ( Spearman r coefficient of TSH was -0.290 ) .
RESULTS	Positive-sided correlation was detected between anti-TPO values and thyroid tissue strain index ratio ( Spearman r coefficient of anti-TPO was 0.682 ) .
RESULTS	The median strain index ratio of patients with CAT ( 1.390.72 ) was significantly higher than the mean ratio of the controls ( 0.760.55 ) .
RESULTS	The area under the receiver operating characteristic curve was 0.775 ( 95 % confidence interval ) .
RESULTS	The optimal cut-off value ( in which the sum of sensitivity and specificity was highest ) for the prediction of diffuse thyroid pathology was 0.677 .
RESULTS	For this cut-off ratio , thyroid stiffness had 96 % sensitivity and 67 % specificity .
RESULTS	A total of 30 of 31 patients ( 96 % ) and a total of 7 of 21 healthy controls ( 33 % ) exceeded the cut-off points .
CONCLUSIONS	The strain index ratio was higher in CAT than in normal thyroid parenchyma in real-time ultrasound elastography .
CONCLUSIONS	Thus , it seems to be a useful method for the assessment of CAT with real-time ultrasound elastography , and further studies assessing the correlation of sonoelastography findings and histopathological subtypes of CAT would enrich the findings of the present study .
CONCLUSIONS	In our study , we detected the stiffness ratio of the thyroid tissue in patients with CAT .
CONCLUSIONS	The cut-off value should be helpful for diagnosis or follow-up of the recently developed lesions such as lymphoma , malign nodule , etc. based on CAT .
CONCLUSIONS	This study should also encourage new studies about CAT and ultrasound elastography .

###24738121
OBJECTIVE	The aim of the present study was to evaluate the surgical and obstetric results of laparoscopy versus laparotomy in the management of ovarian cyst during pregnancy .
METHODS	Sixty-nine eligible patients who met our criteria were randomly divided into the laparoscopy group ( n = 33 ) and the laparotomy group ( n = 36 ) .
METHODS	The two groups were compared for their surgical and obstetric outcomes and the extent of pelvic adhesion discovered in later cesarean section ( CS ) .
RESULTS	The laparoscopy group had less blood loss ( 4315 vs 5113mL , P = 0.02 ) , shorter postoperative hospital stay ( 2.90.5 vs 5.80.6 days , P < 0.001 ) , and lower postoperative pain score ( 2.71.2 vs 5.91.5 , P < 0.001 ) compared with the laparotomy group .
RESULTS	The operative time , neonates ' Apgar scores and birthweights between the two groups showed no significant differences ( P > 0.05 ) .
RESULTS	Sixteen patients in the laparoscopy group , and 15 patients in the laparotomy group underwent cesarean section .
RESULTS	The filmy and dense type adhesion rate was significantly different between the laparoscopy group and the laparotomy group ( 6.25 % vs 53.3 % , and 0 % vs 20 % , respectively ) .
CONCLUSIONS	The present results suggest that laparoscopy is a better choice than laparotomy for ovarian cyst during pregnancy , with less blood loss , less postoperative pain and less postoperative hospital stay .
CONCLUSIONS	It offers a faster recovery , results in less pelvic adhesion and does not affect the fetus ; however , studies encompassing larger numbers of cases are needed .

###24711552
OBJECTIVE	Exemestane , a steroidal aromatase inhibitor , reduced invasive breast cancer incidence by 65 % among 4,560 postmenopausal women randomly assigned to exemestane ( 25 mg per day ) compared with placebo in the National Cancer Institute of Canada ( NCIC ) Clinical Trials Group MAP .3 ( Mammary Prevention 3 ) trial , but effects on quality of life ( QOL ) were not fully described .
METHODS	Menopause-specific and health-related QOL were assessed by using the four Menopause-Specific Quality of Life Questionnaire ( MENQOL ) domains and the eight Medical Outcomes Study Short Form Health Survey ( SF-36 ) scales at baseline , 6 months , and yearly thereafter .
METHODS	MENQOL questionnaire completion was high ( 88 % to 98 % ) in both groups at each follow-up visit .
METHODS	Change scores for each MENQOL and SF-36 scale , calculated at each assessment time relative to baseline , were compared by using the Wilcoxon rank-sum test .
METHODS	Clinically important worsened QOL was defined as a MENQOL change score increase of more than 0.5 ( of 8 ) points and an SF-36 change score decrease of more than 5 ( of 100 ) points from baseline .
RESULTS	Exemestane had small negative effects on women 's self-reported vasomotor symptoms , sexual symptoms , and pain , which occurred mainly in the first 6 months to 2 years after random assignment .
RESULTS	However , these changes represented only a small excess number of women being given exemestane with clinically important worsening of QOL at one time or another ; specifically , 8 % more in the vasomotor domain and 4 % more each in the sexual domain and for pain .
RESULTS	No other between-group differences were observed .
RESULTS	Overall , slightly more women in the exemestane arm ( 32 % ) than in the placebo arm ( 28 % ) discontinued assigned treatment .
CONCLUSIONS	Exemestane given for prevention has limited negative impact on menopause-specific and health-related QOL in healthy postmenopausal women at risk for breast cancer .

###24698672
OBJECTIVE	To explore the efficacy and safty of sorafenib in Child-Pugh class B to class C hepatocellular carcinoma ( HCC ) .
METHODS	In this three-center open-label study from November 2011 to May 2013 , we randomly assigned 189 patients with advanced Child-Pugh class B or C HCC patients into two groups , one group with 95 patient to receive sorafenib ( 400 mg a time , twice a day ) and the other group with 94 patients to receive best supportive care .
METHODS	The primary end points were progression-free survival and overall survival .
RESULTS	The median progression-free survival was 2.2 months and 1.9 months in the sorafenib group and best supportive care group respectively ( Hazard ratio in the sorafenib group , 0.55 ; 95 % confidence interval , 0.40-0 .75 ; P = 0.002 ) .
RESULTS	The median overall survival was 4.0 months and 3.5 months in the sorafenib group and best supportive care group respectively ( Hazard ratio in the sorafenib group , 0.48 ; 95 % confidence interval , 0.35-0 .68 ; P < 0.001 ) .
RESULTS	The main adverse effect of sorafenib was rash and acne of the skin ( in 51.7 % patients ) .
RESULTS	The incidences of severe rash , diarrhea , and dry skin were 5.6 % , 5.6 % , and 2.2 % in the sorafenib group .
RESULTS	One patient reached partial response in the sorafenib group .
CONCLUSIONS	Sorafenib is safe in patients with liver function impaired advanced HCC .
CONCLUSIONS	It is effective in terms of progression-free survival and overall survival compared with best supportive care .
CONCLUSIONS	Liver functions are the important predictive factors .

###24341368
BACKGROUND	Cardiovascular disease ( CVD ) is an important worldwide cause of mortality .
BACKGROUND	In The Netherlands , CVD is the leading cause of death for women and the second cause of death for men .
BACKGROUND	Recommendations for diagnosis and treatment of CVD are not well implemented in primary care .
BACKGROUND	In this study , we aim to examine the effectiveness of a tailored implementation program targeted at practice nurses to improve healthcare for patients with ( high risk for ) CVD .
METHODS	A two-arm cluster randomized trial is planned .
METHODS	We offer practice nurses a tailored program to improve adherence to six specific recommendations related to blood pressure and cholesterol target values , risk profiling and lifestyle advice .
METHODS	Practice nurses are offered training and feedback on their motivational interviewing technique and an e-learning program on cardiovascular risk management ( CVRM ) .
METHODS	They are also advised to screen for the presence and severity of depressive symptoms in patients .
METHODS	We also advise practice nurses to use selected E-health options ( selected websites and Twitter-consult ) in patients without symptoms of depression .
METHODS	Patients with mild depressive symptoms are referred to a physical exercise group .
METHODS	We recommend referring patients with major depressive symptoms for assessment and treatment of depressive symptoms if appropriate before starting CVRM .
METHODS	Data from 900 patients at high risk of CVD or with established CVD will be collected in 30 general practices in several geographical areas in The Netherlands .
METHODS	The primary outcome measure is performance of practice nurses in CVRM and reflects application of recommendations for personalized counselling and education of CVRM patients .
METHODS	Patients ' health-related lifestyles ( physical exercise , diet and smoking status ) will be measured with validated questionnaires and medical record audit will be performed to document estimated CVD risk .
METHODS	Additionally , we will survey and interview participating healthcare professionals for exploration of processes of change .
METHODS	The control practices will provide usual care .
CONCLUSIONS	Tailored interventions can improve healthcare .
CONCLUSIONS	An understanding of the methods to reach the improved healthcare can be improved .
CONCLUSIONS	This research contributes a share of it .
CONCLUSIONS	Identification of the determinants of practice and developing implementation interventions were two steps which were completed .
CONCLUSIONS	The subsequent step was implementation of the tailored intervention program .
BACKGROUND	Name trial register : Nederlands trial register .
BACKGROUND	Web address of trial register : http://www.trialregister.nl .
BACKGROUND	Data of registration : 11 July 2013 .
BACKGROUND	Number of registration : NTR4069 .

###24512981
OBJECTIVE	This randomised phase III trial evaluated first-line trabectedin versus doxorubicin-based chemotherapy ( DXCT ) in patients with advanced/metastatic translocation-related sarcomas ( TRS ) .
METHODS	Patients were randomly assigned ( 1:1 ) to receive trabectedin 1.5 mg/m2 24-h intravenous ( i.v. ) infusion every 3 weeks ( q3wk ) ( Arm A ) , or doxorubicin 75 mg/m2 i.v. , q3wk , or doxorubicin 60 mg/m2 i.v. plus ifosfamide ( range , 6-9 g/m2 ) i.v. q3wk ( Arm B ) .
METHODS	Progression-free survival ( PFS ) by independent review was the primary efficacy end-point .
RESULTS	One hundred and twenty-one patients were randomised ; 88 of them had TRS confirmed by central pathology review ( efficacy population ) .
RESULTS	Twenty-nine PFS events were assessed by independent review ( 16 with trabectedin ; 13 with DXCT ) .
RESULTS	PFS showed non-significant difference between arms ( stratified log rank test , p = 0.9573 ; hazard ratio = 0.86 , p = 0.6992 ) .
RESULTS	At the time of this analysis , 63.9 % and 58.3 % of patients were alive in trabectedin and DXCT arms , respectively .
RESULTS	There was no statistically significant difference in survival curves .
RESULTS	Response rate according to Response Evaluation Criteria in Solid Tumours ( RECIST ) v. 1.0 was significantly higher in DXCT arm ( 27.0 % versus 5.9 % ) , but response according to Choi criteria showed fewer differences between treatment arms ( 45.9 % versus 37.3 % ) .
RESULTS	Safety profile was as expected for both arms , with higher incidence of severe neutropenia , alopecia and mucositis in the DXCT arm .
CONCLUSIONS	Neither trabectedin nor doxorubicin-based chemotherapy showed significant superiority in the first-line treatment of patients with advanced translocation-related sarcoma .

###25271499
METHODS	Multicenter randomized trial with patients listed as sick for 1 to 12 months due to neck or back pain and referred to secondary care .
OBJECTIVE	To compare the return-to-work ( RTW ) rate among patients offered work-focused rehabilitation or multidisciplinary rehabilitation .
BACKGROUND	A growing number of studies have focused on the RTW processes associated with patients with back pain .
BACKGROUND	Many studies have combined a workplace focus with multidisciplinary treatments ; however , this focus has not been evaluated in Norway among patients with neck and back pain thus far .
METHODS	A total of 405 patients who were referred to the spine clinics at 2 university hospitals in Norway were randomly assigned into work-focused and control intervention groups .
METHODS	The existing treatments at each hospital were used as the control interventions , which entailed either a comprehensive multidisciplinary intervention or a brief multidisciplinary intervention .
METHODS	The RTW rates and proportions were compared at 12 months .
RESULTS	During the first 12 months after inclusion , 142 ( 70 % ) participants in the work-focused rehabilitation group and 152 ( 75 % ) participants in the control group returned to work .
RESULTS	The median time to RTW was 161 days in the work-focused group and 158 days in the control group .
RESULTS	A comparison of the work-focused and control interventions revealed a relative RTW probability ( hazard ratio ) of 0.94 ( 95 % confidence interval = 0.75-1 .17 ) after adjusting for age , sex , and education .
CONCLUSIONS	The results suggest that a focus on the workplace in specialist care does not substantially alter the RTW rate compared with standard multidisciplinary treatments .

###24837215
BACKGROUND	Compared with open resection , laparoscopic resection of rectal cancers is associated with improved short-term outcomes , but high-level evidence showing similar long-term outcomes is scarce .
BACKGROUND	We aimed to compare survival outcomes of laparoscopic surgery with open surgery for patients with mid-rectal or low-rectal cancer .
METHODS	The Comparison of Open versus laparoscopic surgery for mid or low REctal cancer After Neoadjuvant chemoradiotherapy ( COREAN ) trial was an open-label , non-inferiority , randomised controlled trial done between April 4 , 2006 , and Aug 26 , 2009 , at three centres in Korea .
METHODS	Patients ( aged 18-80 years ) with cT3N0-2M0 mid-rectal or low-rectal cancer who had received preoperative chemoradiotherapy were randomly assigned ( 1:1 ) to receive either open or laparoscopic surgery .
METHODS	Randomisation was stratified by sex and preoperative chemotherapy regimen .
METHODS	Investigators were masked to the randomisation sequence ; patients and clinicians were not masked to the treatment assignments .
METHODS	The primary endpoint was 3 year disease-free survival , with a non-inferiority margin of 15 % .
METHODS	Analysis was by intention to treat .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT0040951 .
RESULTS	We randomly assigned 340 patients to receive either open surgery ( n = 170 ) or laparoscopic surgery ( n = 170 ) .
RESULTS	3 year disease-free survival was 725 % ( 95 % CI 650-786 ) for the open surgery group and 792 % ( 723-846 ) for the laparoscopic surgery group , with a difference that was lower than the prespecified non-inferiority margin ( -67 % , 95 % CI -158 to 24 ; p < 00001 ) .
RESULTS	25 ( 15 % ) patients died in the open group and 20 ( 12 % ) died in the laparoscopic group .
RESULTS	No deaths were treatment related .
CONCLUSIONS	Our results show that laparoscopic resection for locally advanced rectal cancer after preoperative chemoradiotherapy provides similar outcomes for disease-free survival as open resection , thus justifying its use .
BACKGROUND	National Cancer Center , South Korea .

###24671049
BACKGROUND	Great strides have been made in improving heart health in the United States during the last 2 decades , yet these strides have not encompassed many ethnic minority populations .
BACKGROUND	There are significant health disparity gaps stemming from both a paucity of valid research and a lack of culturally sensitive interventions .
BACKGROUND	In particular , many Korean Americans with chronic illnesses encounter difficulty navigating the healthcare system because of limited health literacy .
METHODS	The effect of a multimodal Self-Help Intervention Program on the Control of High Blood Pressure ( HBP ) was tested in a community-based clinical trial for Korean American seniors .
METHODS	Of 440 seniors enrolled , 369 completed the study ( 184 in the intervention group and 185 in the control group ; mean age = 70.95.3 years ) .
METHODS	The intervention group received 6 weekly educational sessions on HBP management skill building , including health literacy training , followed by telephone counseling and home blood pressure ( BP ) monitoring for 12 months .
RESULTS	Findings support that the Self-Help Intervention Program on the Control of HBP was effective in controlling BP in this ethnic/linguistic minority population .
RESULTS	The BP control rates for the intervention and control groups were 49.5 % vs. 43.2 % at baseline , 58.5 % vs. 42.4 % at 6 months , 67.9 % vs. 52.5 % at 12 months , and 54.3 % vs. 53.0 % at 18 months .
RESULTS	Significant changes were observed over time in some psychobehavioral outcomes , including self-efficacy for BP control , medication adherence behavior , HBP knowledge , and depression .
CONCLUSIONS	The study findings suggest that the multimodal Self-Help Intervention Program on the Control of HBP is effective at promoting optimal HBP control for this ethnic/linguistic minority population .
BACKGROUND	NCT00406614 .

###25229902
OBJECTIVE	To investigate the impact of education on the quality of life of parent of children with leukemia referred to the oncology clinic at Kerman 's Afzali-Poor hospital ( Iran ) .
METHODS	This was an interventional study with 80 parents of children with leukemia ; all of the caregivers were mothers and were included in the research .
METHODS	They were chosen using the convenience sampling method and categorized randomly into two groups ( intervention and control , each with 40 participants ) .
METHODS	Research tools included demographic information and Quality of Life ( QoL ) scale ( a specific form for first-degree family caregivers of patients with leukemia ) .
METHODS	Questionnaires were applied at the beginning of the research and after three months ; this second evaluation coincided in the study group with the end of the intervention .
METHODS	The intervention lasted four sessions of 45 - to 65-minute classes , with lectures and question and answer sessions , educational booklets , and posters in groups with 4 - 6 members .
RESULTS	In the first evaluation , mean QoL scores in the study and control groups were 224.9 and 225.7 , which , after three months changed to 338.2 and 226.7 , respectively .
RESULTS	T-test verified these increases ( p < 0.05 ) in quality of life in the intervention group .
CONCLUSIONS	According to the effectiveness of the education on the parent 's quality of life , it is recommended to implement consulting and educational programs for parents , especially parents of children with leukemia , to promote care , reduce anxiety , and consequently , enhance quality of life .

###24343824
OBJECTIVE	To determine the response of nebulized magnesium sulfate on the lung function of acetylcholine-induced asthma children .
METHODS	Three hundred and thirty children of asthma with positive bronchial provocation test were randomly divided into three groups : magnesium sulfate , albuterol , and a combination of magnesium sulfate and albuterol .
METHODS	Lung function was compared between the three groups .
RESULTS	Forced expiratory volume in one second ( FEV1 ) and peak expiratory flow ( PEF ) as percentage over predicted at 10 min and 20 min in albuterol and combination group were significantly improved when compared to magnesium group .
RESULTS	The changes in FEV1 and PEF expressed as absolute and percentage over predicted was not statistically significant from baseline to 20 min in magnesium , albuterol , and combination of magnesium sulfate and albuterol .
RESULTS	There was no significant adverse effect observed during the present study .
CONCLUSIONS	Nebulized magnesium sulfate alone has a bronchodilatory effect in Ach-induced asthmatic children .
CONCLUSIONS	The combination of MgSO4 and albuterol did not has a synergistic effect .

###24934276
BACKGROUND	Genome-wide association studies have yet to identify the majority of genetic variants involved in asthma .
BACKGROUND	We hypothesized that expression quantitative trait locus ( eQTL ) mapping can identify novel asthma genes by enabling prioritization of putative functional variants for association testing .
OBJECTIVE	We evaluated 6706 cis-acting expression-associated variants ( eSNPs ) identified through a genome-wide eQTL survey of CD4 ( + ) lymphocytes for association with asthma .
METHODS	eSNPs were tested for association with asthma in 359 asthmatic patients and 846 control subjects from the Childhood Asthma Management Program , with verification by using family-based testing .
METHODS	Significant associations were tested for replication in 579 parent-child trios with asthma from Costa Rica .
METHODS	Further functional validation was performed by using formaldehyde-assisted isolation of regulatory elements ( FAIRE ) quantitative PCR and chromatin immunoprecipitation PCR in lung-derived epithelial cell lines ( Beas-2B and A549 ) and Jurkat cells , a leukemia cell line derived from T lymphocytes .
RESULTS	Cis-acting eSNPs demonstrated associations with asthma in both cohorts .
RESULTS	We confirmed the previously reported association of ORMDL3/GSDMB variants with asthma ( combined P = 2.9 10 ( -8 ) ) .
RESULTS	Reproducible associations were also observed for eSNPs in 3 additional genes : fatty acid desaturase 2 ( FADS2 ; P = .002 ) , N-acetyl -- D-galactosaminidase ( NAGA ; P = .0002 ) , and Factor XIII , A1 ( F13A1 ; P = .0001 ) .
RESULTS	Subsequently , we demonstrated that FADS2 mRNA is increased in CD4 ( + ) lymphocytes in asthmatic patients and that the associated eSNPs reside within DNA segments with histone modifications that denote open chromatin status and confer enhancer activity .
CONCLUSIONS	Our results demonstrate the utility of eQTL mapping in the identification of novel asthma genes and provide evidence for the importance of FADS2 , NAGA , and F13A1 in the pathogenesis of asthma .

###26054203
OBJECTIVE	To observe the clinical therapeutic effect of blood-letting plus acupuncture intervention for acute facial paralysis with pain ( damp-heat type of liver and gallbladder ) .
METHODS	A total of 120 cases of acute facial paralysis with pain were randomly and equally divided into control group and treatment group .
METHODS	Patients of the control group were treated by simple acupuncture therapy only , and patients of the treatment group treated by acupuncture plus bloodletting at the ipsilateral Yangbai ( GB 14 ) and Quanliao ( SI 18 ) , and Dazhui ( GV 14 ) and Yifeng ( TE 17 ) , alternatively .
METHODS	Shallow-acupuncture stimulation of ipsilateral Cuanzhu ( BL 2 ) , Sizhukong ( TE 23 ) , Sibai ( ST 2 ) , Dicang ( ST 4 ) , Jiache ( ST 6 ) , Yingxiang ( SP 9 ) , and bilateral Hegu ( LI 4 ) , Yanglingquan ( GB 34 ) and Xingjian ( LR 2 ) was administered for 30 min , once daily for one month .
METHODS	The patients ' facial pain degree was evaluated by visual analogue scale ( VAS ) , and the pain duration during acute stage was recorded .
METHODS	The facial nerve function and facial nerve function recovery ( grade II ) time were determined by using Sunnybrook Facial Grading scale and House-Brackmann ( HB ) grading scale , respectively .
RESULTS	In comparison with pre-treatment , the post-aurem pain scores after the first treatment and after the acute stage were significantly decreased , and the facial nerve function scores after the treatment were significantly increased in both control and treatment groups ( P < 0.01 ) , and the effects of the treatment group were significantly superior to those of the control group ( P < 0.01 ) .
RESULTS	The post-aurem pain duration and the time of facial nerve function recovery ( HB ) of the treatment group were considerably lower than those of the control group ( P < 0.01 ) .
RESULTS	Of the 58 and 59 facial palsy patients in the control and treatment groups , 16 ( 27.6 % ) and 24 ( 40.7 % ) were cured , 18 ( 31.0 % ) and 23 ( 39.0 % ) experienced marked improvement , 15 ( 25.9 % ) and 10 ( 16.9 % ) were improved , and 9 ( 15.5 % ) and 2 ( 3.4 % ) were failed , with the effective rate being 85.0 % and 96.6 % , respectively .
CONCLUSIONS	Bloodletting combined acupuncture is effective in the treatment of acute facial paralysis with pain .

###24507462
BACKGROUND	Therapy for stroke prevention in older persons with atrial fibrillation ( AF ) is underutilized despite evidence to support its effectiveness .
BACKGROUND	To prevent stroke in this high-risk population , antithrombotic treatment is necessary .
BACKGROUND	Given the challenges and inherent risks of antithrombotic therapy , decision-making is particularly complex for clinicians , necessitating comprehensive risk : benefit assessments .
BACKGROUND	Targeted interventions are urgently needed to support clinicians in this context ; the Computerized Antithrombotic Risk Assessment Tool ( CARAT ) offers a unique approach to this clinical problem .
METHODS	This study ( a prospective , cluster-randomized controlled clinical trial ) will be conducted across selected regions in the state of New South Wales , Australia .
METHODS	Fifty GPs will be randomized to either the ` intervention ' or ` control ' arm , with each GP recruiting 10 patients ( aged 65 with AF ) ; target sample size is 500 patients .
METHODS	GPs in the intervention arm will use CARAT during routine patient consultations to : assess risk factors for stroke , bleeding and medication misadventure ; quantify the risk/benefit ratio of antithrombotic treatment , identify the recommended therapy , and decide on the treatment course , for an individual patient .
METHODS	CARAT will be applied by the GP at baseline and repeated at 12 months to identify any changes to treatment requirements .
METHODS	At baseline , the participant ( patients and GPs ) characteristics will be recorded , as well as relevant practice and clinical parameters .
METHODS	Patient follow up will occur at 1 , 6 , and 12 months via telephone interview to identify changes to therapy , medication side effects , or clinical events .
CONCLUSIONS	This project tests the utility of a novel decision support tool ( CARAT ) in improving the use of preventative therapy to reduce the significant burden of stroke .
CONCLUSIONS	Importantly , it targets the interface of patient care ( general practice ) , addresses the at-risk population , evaluates clinical outcomes , and offers a tool that may be sustainable via integration into prescribing software and primary care services .
CONCLUSIONS	GP support and guidance in identifying at risk patients for the appropriate selection of therapy is widely acknowledged .
CONCLUSIONS	This trial will evaluate the impact of CARAT on the prescription of antithrombotic therapy , its longer-term impact on clinical outcomes including stroke and bleeding , and clinicians perceived utility of CARAT in practice .
BACKGROUND	Australian New Zealand Clinical Trials Registry : ACTRN12613000060741 .

###24278962
OBJECTIVE	To evaluate the clinical effectiveness of indirect composite restorations in permanent molars with excessive substance loss in pediatric patients who have undergone root canal treatments .
METHODS	Molars of 29 pediatric patients underwent endodontic treatment .
METHODS	Sixteen molars were restored with an indirect posterior composite resin restoration and 13 molars were restored with a direct posterior composite resin restoration .
METHODS	The success of the restorations was evaluated for 2 years based on United States Public Health Service ( USPHS ) criteria , photographs after staining with basic fuchsine , and radiographic data .
METHODS	Data obtained from both groups were compared using the Mann-Whitney U-test and Wilcoxon signed rank test .
RESULTS	Evaluation of the clinical and radiographic data revealed no observable , statistically significant differences between the posterior and the indirect posterior composites ( p > 0.05 ) .
RESULTS	However , evaluation of photos taken of the patients ' molars after staining with basic fuchsin revealed that direct posterior composites showed increased staining on the margins of the restorations after six months ( p < 0.05 ) .
CONCLUSIONS	Considering the difficulties of restoring endodontically treated permanent teeth with excessive substance loss in child patients , indirect restorations may be seen as a better option .

###25036037
BACKGROUND	Salt intake has been implicated in the pathogenesis of abdominal aortic aneurysm ( AAA ) through studies in rodent models but not previously studied in humans .
BACKGROUND	The aim of this study was to examine the association between reported addition of salt to food and the prevalence of AAA .
METHODS	A risk factor questionnaire which contained a question about salt intake was included as part of a population screening study for AAA in 11742 older men .
METHODS	AAA presence was assessed by abdominal ultrasound imaging using a reproducible protocol .
RESULTS	The prevalence of AAA was 6.9 , 8.5 and 8.6 % in men who reported adding salt to food never , sometimes and always , respectively , p = 0.005 .
RESULTS	Addition of salt to food sometimes ( odds ratio [ OR ] : 1.22 , 95 % confidence interval [ CI ] : 1.03-1 .44 ) or always ( OR : 1.23 , 95 % CI 1.04-1 .47 ) was independently associated with AAA after adjustment for other risk factors including age , waist-hip ratio , blood pressure , history of hypertension , high cholesterol , angina , diabetes , myocardial infarction and stroke .
RESULTS	Salt intake was also independently associated with aortic diameter ( beta 0.023 , p = 0.012 ) .
RESULTS	In men with no prior history of hypertension , high cholesterol , angina , myocardial infarction or stroke ( n = 4185 ) , the association between addition of salt to food sometimes ( OR : 1.41 , 95 % CI 0.96-2 .08 ) or always ( OR : 1.52 , 95 % CI 1.04-2 .22 ) and AAA remained evident .
CONCLUSIONS	Reported salt intake is associated with AAA in older men .
CONCLUSIONS	Additional studies are needed to determine whether reducing salt intake would protect against AAA .

###24352094
OBJECTIVE	This study investigated how performance was affected after soccer players , in a postprandial state , ingested a 7 % carbohydrate ( CHO ) solution compared to a placebo ( 0 % CHO ) during a simulated soccer match .
METHODS	Using a double-blind placebo-controlled design , 22 trained male league soccer players ( age : 24 7 years , wt : 73.4 12.0 kg , VO2max : 51.8 4.3 mL O2/kg/min ) completed two trials , separated by 7 days , during which they ingested , in random order , 700 mL of either a 7 % CHO or placebo drink during a simulated soccer match .
METHODS	Ratings of perceived exertion ( RPE ) , agility , timed and run to fatigue were measured during the trials .
RESULTS	Change in agility times was not altered by CHO vs. placebo ingestion ( 0.57 1.48 vs. 0.66 1.00 , p = 0.81 ) .
RESULTS	Timed runs to fatigue were 381 267 s vs. 294 159 s for the CHO and placebo drinks , respectively ( p = 0.11 ) .
RESULTS	Body mass modified the relationship between time to fatigue and drink ingestion ( p = 0.02 for drink body mass ) , such that lower body mass was associated with increased time to fatigue when the players ingested CHO , but not placebo .
RESULTS	RPE values for the final stage of the simulated soccer match were 8.5 1.7 and 8.6 1.5 for the CHO and placebo drinks respectively ( p = 0.87 ) .
CONCLUSIONS	The group data showed that the 7 % CHO solution ( 49 g CHO ) did not significantly improve performance during a simulated soccer match in league soccer players who had normal pre-match nutrition .
CONCLUSIONS	However , when adjusting for body mass , increasing CHO intake was associated with improved time to fatigue during the simulated soccer match .

###24529580
OBJECTIVE	To show the noninferiority of silodosin 8-mg once-daily ( QD ) to 4-mg twice-daily ( BID ) in efficacy and safety in patients with lower urinary tract symptoms or benign prostatic hyperplasia in the Korean population .
METHODS	A prospective , multicenter , double-blind , randomized , comparative study was conducted .
METHODS	A total of 532 male patients aged 50 years with lower urinary tract symptoms or benign prostatic hyperplasia were included .
METHODS	All patients received silodosin QD or BID for 12 weeks .
METHODS	The primary end point was the change from baseline in total International Prostate Symptom Score ( IPSS ) at 12 weeks .
METHODS	Adverse drug reactions , vital signs , and laboratory tests were recorded .
RESULTS	A total of 424 patients were randomized to the silodosin QD or BID groups .
RESULTS	These groups were not significantly different in baseline characteristics .
RESULTS	The mean total IPSS change in QD group was not inferior to that in BID group ( -6.70 and -6.94 , respectively ; 95 % confidence interval , -0.88 to 1.36 ) .
RESULTS	The QD and BID groups did not significantly differ in the following : percentages of patients with 25 % ( 63.41 % and 67.82 % , respectively ; P = .349 ) or 4-point improvement in total IPSS ( 65.85 % and 69.31 % , respectively ; P = .457 ) , maximum urinary flow rate improvement 30 % ( 47.32 % and 40.59 % , respectively ; P = .172 ) , changes in IPSS voiding subscore ( -4.42 4.93 and -4.65 4.77 ; P = .641 ) , IPSS storage subscore ( -2.05 3.07 and -2.52 2.97 ; P = .117 ) , quality of life ( -1.19 1.49 and -1.40 1.42 ; P = .136 ) , maximum urinary flow rate ( 3.55 5.93 and 3.74 6.79 mL/s ; P = .768 ) , International Continence Society male questionnaire score , Patient Goal Achievement Score , or Treatment Satisfaction Question .
RESULTS	The 2 groups had similar frequencies of adverse drug reactions .
CONCLUSIONS	QD administration of silodosin was not inferior to BID in efficacy .
CONCLUSIONS	The 2 groups had similar adverse drug reaction profiles .

###25074885
BACKGROUND	Analgesic and wound-healing effects of cinnamon , a widely used spice , have been shown in laboratory rats .
BACKGROUND	However , we found no human studies in this area .
OBJECTIVE	The aim of this study was to assess the effect of cinnamon on perineal pain and healing of episiotomy incision .
METHODS	In this double-blind , randomized , placebo-controlled trial , 144 postpartum women were allocated into two groups , using stratified block randomization , 1 h after completion of episiotomy repair .
METHODS	They received cinnamon or placebo ointment , 2 mL every 12 h for 10 d.
METHODS	Perineal pain and wound healing were assessed using visual analogue scale ( 0-10 ) and Redness , Edema , Ecchymosis , Discharge , Approximation scale ( 0-15 ) , respectively .
METHODS	General linear model was used to compare the groups on the outcomes adjusted for baseline values and stratified factors .
RESULTS	Follow-up rate was 100 % up to the 8 h time point in both groups , and 86 % ( 62 of 72 ) in the cinnamon group and 85 % ( 61 of 72 ) in the placebo group at day 10-11 after delivery .
RESULTS	Pain score in the cinnamon group was significantly lower than that in the placebo group at ( 41 ) h ( adjusted difference : -0.6 , 95 % confidence interval : -1.0 to -0.2 ) and ( 81 ) h ( -0.9 , -1.4 to -0.3 ) after intervention , and on the 10-11th day after delivery ( -1.4 , -2.0 to -0.7 ) .
RESULTS	Also the cinnamon group showed significantly more improvement than the control group in healing score at ( 81 ) h ( -0.2 , -0.4 to -0.04 ) and the 10-11th day after delivery ( -1.6 , -2.0 to -1.1 ) .
CONCLUSIONS	Cinnamon can be used for reducing perineal pain and improving healing of episiotomy incision .

###25885704
BACKGROUND	Research suggests that the food environment influences individual eating practices .
BACKGROUND	To date , little is known about effective interventions to improve the food environment of restaurants and food stores and promote healthy eating in rural communities .
BACKGROUND	We tested `` Waupaca Eating Smart '' ( WES ) , a pilot intervention to improve the food environment and promote healthy eating in restaurants and supermarkets of a rural community .
BACKGROUND	WES focused on labeling , promoting , and increasing the availability of healthy foods .
METHODS	We conducted a randomized community trial , with two Midwestern U.S. communities randomly assigned to serve as intervention or control site .
METHODS	We collected process and outcome data using baseline and posttest owner and customer surveys and direct observation methods .
METHODS	The RE-AIM framework was used to guide the evaluation and organize the results .
RESULTS	Seven of nine restaurants and two of three food stores invited to participate in WES adopted the intervention .
RESULTS	On a 0-4 scale , the average level of satisfaction with WES was 3.14 ( SD = 0.69 ) for restaurant managers and 3 ( SD = 0.0 ) for store managers .
RESULTS	On average , 6.3 ( SD = 1.1 ) out of 10 possible intervention activities were implemented in restaurants and 9.0 ( SD = 0.0 ) out of 12 possible activities were implemented in food stores .
RESULTS	One month after the end of the pilot implementation period , 5.4 ( SD = 1.6 ) and 7.5 ( SD = 0.7 ) activities were still in place at restaurants and food stores , respectively .
RESULTS	The intervention reached 60 % of customers in participating food outlets .
RESULTS	Restaurant food environment scores improved from 13.4 to 24.1 ( p < 0.01 ) in the intervention community and did not change significantly in the control community .
RESULTS	Food environment scores decreased slightly in both communities .
RESULTS	No or minimal changes in customer behaviors were observed after a 10-month implementation period .
CONCLUSIONS	The intervention achieved high levels of reach , adoption , implementation , and maintenance , suggesting the feasibility and acceptability of restaurant-and food store-based interventions in rural communities .
CONCLUSIONS	Pilot outcome data indicated very modest levels of effectiveness , but additional research adequately powered to test the impact of this intervention on food environment scores and customer behaviors needs to be conducted in order to identify its potential to promote healthy eating in rural community settings .

###24263273
OBJECTIVE	Shortening the pulse width to 0.3 millisecond holds neurophysiological and clinical promise of making electroconvulsive therapy ( ECT ) safer by reducing cognitive adverse effects .
OBJECTIVE	The exclusive effects of pulse width on autobiographical and subjective memory are largely unstudied .
OBJECTIVE	The aim was to principally investigate during the acute ECT course and at 3 months after ECT autobiographical and subjective memory effects of 0.3-millisecond ultrabrief and 1-millisecond brief-pulse ECT .
METHODS	Patient with severe depression were randomized to 1-millisecond brief-pulse ( n = 20 ) or 0.3-millisecond ultrabrief-pulse ( n = 20 ) right unilateral ECT , both at 6 times the threshold stimulus dose given thrice weekly .
METHODS	Autobiographical Memory Interview ( Kopelman ) and Squire Subjective Memory Questionnaire were administered at baseline , after 8 sessions , end of the acute course , and 3 months later .
RESULTS	Early adult semantic memory worsened significantly over time with brief-pulse compared with ultrabrief ECT : F3 ,88 = 2.60 , P = 0.05 .
RESULTS	There was a significant decline in brief-pulse treatment vis -- vis a significant improvement with ultrabrief-pulse treatment with childhood semantic memory ( P = 0.022 ) , early adult semantic ( P = 0.03 ) , and recent semantic memory ( P = 0.018 ) only at 24 hours after the eighth ECT treatment .
CONCLUSIONS	Clinically meaningful and significant improvement in semantic autobiographical memory occurred in ultrabrief treatment vis -- vis brief-pulse ECT after 8 treatments .
CONCLUSIONS	Ultrabrief treatment offered a small but significant advantage over 1-millisecond brief-pulse high-dose right unilateral ECT with early adult semantic autobiographical memory , which persisted up to 3 months .

###24531938
BACKGROUND	Although femoral nerve block provides good analgesia after total knee arthroplasty ( TKA ) , residual posterior knee pain may decrease patient satisfaction .
BACKGROUND	We compared the efficacy of periarticular infiltration analgesia ( PIA ) and sciatic nerve block ( SNB ) for posterior knee pain .
METHODS	Forty-nine patients scheduled for TKA were prospectively randomized into the PIA group ( n = 25 ) or SNB group ( n = 24 ) and received general anesthesia with ultrasound-guided femoral nerve block ( FNB ) .
METHODS	In the PIA group , 60 ml 0.5 % ropivacaine and 0.3 mg epinephrine were injected intraoperatively into the periarticular soft tissue before inserting the components .
METHODS	In the SNB group , patients received ultrasound-guided SNB with 20 ml 0.375 % ropivacaine and periarticular infiltration with 20 ml normal saline and 0.3 mg epinephrine .
METHODS	We evaluated postoperative pain scores , posterior knee pain , frequency of rescue analgesics for 36 h , and performance time of PIA and SNB .
RESULTS	Visual analogue pain scores at 12-24 h were significantly lower in the PIA group than in the SNB group ( p < 0.05 ) .
RESULTS	The majority of patients had no posterior knee pain .
RESULTS	There were no significant differences between the groups in frequency and time of first administration of rescue analgesics and in side effects .
RESULTS	Time for performance of periarticular infiltration was significantly shorter than that for SNB ( p < 0.05 ) .
RESULTS	The dose of intraoperative remifentanil was significantly lower in the SNB group than in the PIA group ( p < 0.001 ) .
CONCLUSIONS	The combination of FNB and PIA provides sufficient analgesia after TKA .
CONCLUSIONS	The rapid and convenient periarticular infiltration technique could be a good alternative to SNB .

###25923551
BACKGROUND	In Canada , cesarean delivery rates have increased substantially over the past decade .
BACKGROUND	Effective , safe strategies are needed to reduce these rates .
METHODS	We conducted a cluster-randomized , controlled trial of a multifaceted 1.5-year intervention at 32 hospitals in Quebec .
METHODS	The intervention involved audits of indications for cesarean delivery , provision of feedback to health professionals , and implementation of best practices .
METHODS	The primary outcome was the cesarean delivery rate in the 1-year postintervention period .
RESULTS	Among the 184,952 participants , 53,086 women delivered in the year before the intervention and 52,265 women delivered in the year following the intervention .
RESULTS	There was a significant but small reduction in the rate of cesarean delivery from the preintervention period to the postintervention period in the intervention group as compared with the control group ( change , 22.5 % to 21.8 % in the intervention group and 23.2 % to 23.5 % in the control group ; odds ratio for incremental change over time , adjusted for hospital and patient characteristics , 0.90 ; 95 % confidence interval [ CI ] , 0.80 to 0.99 ; P = 0.04 ; adjusted risk difference , -1.8 % ; 95 % CI , -3.8 to -0.2 ) .
RESULTS	The cesarean delivery rate was significantly reduced among women with low-risk pregnancies ( adjusted risk difference , -1.7 % ; 95 % CI , -3.0 to -0.3 ; P = 0.03 ) but not among those with high-risk pregnancies ( P = 0.35 ; P = 0.03 for interaction ) .
RESULTS	The intervention group also had a reduction in major neonatal morbidity as compared with the control group ( adjusted risk difference , -0.7 % ; 95 % CI , -1.3 to -0.1 ; P = 0.03 ) and a smaller increase in minor neonatal morbidity ( adjusted risk difference , -1.7 % ; 95 % CI , -2.6 to -0.9 ; P < 0.001 ) .
RESULTS	Changes in minor and major maternal morbidity did not differ significantly between the groups .
CONCLUSIONS	Audits of indications for cesarean delivery , feedback for health professionals , and implementation of best practices , as compared with usual care , resulted in a significant but small reduction in the rate of cesarean delivery , without adverse effects on maternal or neonatal outcomes .
CONCLUSIONS	The benefit was driven by the effect of the intervention in low-risk pregnancies .
CONCLUSIONS	( Funded by the Canadian Institutes of Health Research ; QUARISMA Current Controlled Trials number , ISRCTN95086407 . )

###24527598
OBJECTIVE	To determine the effect of elastic taping on patients with patellofemoral pain and its impact on the onset time of vastusmedialis and vastuslateralis .
METHODS	Eligible patients were assigned into the treatment and control groups randomly .
METHODS	Patients in the treatment group received a 5-day taping with therapeutic stretch .
METHODS	Patients in the control group were give placebo taping without therapeutic stretch .
METHODS	Ultrasound therapy was applied to all of the participants as a basic treatment .
METHODS	The levels of pain and surface electromyography were evaluated before treatment , after the first taping and on the Gh day ( without taping ) .
RESULTS	Patients in the treatment group experienced immediate improvement in pain and onset time of vastusmedialis and vastuslateralis compared with the controls .
RESULTS	On the 6th day ( without taping ) , further improvement was achieved in pain and onset time of vastusmedialis and vastuslateralis in the treatment group compared with the controls ( P < 0.05 ) .
CONCLUSIONS	Elastic taping can effectively improve pain and onset time of vastusmedialis and vastuslateralis .

###25128485
BACKGROUND	Heparin is often prescribed during pregnancy with the intention of improving perinatal outcomes on the basis that it exerts an anticoagulant action in the inter-villous space .
BACKGROUND	Accumulating in-vitro and in-vivo evidence indicates that heparin 's beneficial effects in pregnancy may result from ` non-anticoagulant ' effects including the promotion of angiogenesis .
METHODS	To study the effect of heparin within the placenta , we performed secondary analyses on a pilot trial where 32 women with negative thrombophilia screens and second-trimester evidence of placental insufficiency were randomized to standard care or antenatal self-administration of unfractionated heparin ( UFH ) 7500 IU twice-daily .
METHODS	Serial placental ultrasound images were reviewed and compared with histo-pathologic findings following delivery .
RESULTS	There were no differences between the two arms in either the evolution of abnormal placental lesions on ultrasound ( p = 0.75 ) or evidence of maternal vascular under-perfusion on histopathology ( p = 0.89 ) .
RESULTS	In pregnancies considered at increased risk for adverse pregnancy outcomes based on previous history or abnormal serum marker screen , early ( second-trimester ) placental ultrasound , reflecting developmental pathology had better test characteristics ( sensitivity 77.8 % ; positive predictive value 80.8 % ) for predicting adverse pregnancy outcomes than third-trimester ultrasound that is reflective of placental thrombotic injury .
CONCLUSIONS	Administration of UFH did not prevent the development or evolution of abnormal placental lesions on placental ultrasound or evidence of maternal vascular underperfusion on placental histo-pathology .
CONCLUSIONS	Second-trimester placental ultrasound may be of value in predicting those at greatest risk of adverse outcomes .

###25733626
BACKGROUND	Benefits of plant sterols ( PS ) for cholesterol lowering are compromised by large variability in efficacy across individuals .
BACKGROUND	High fractional cholesterol synthesis measured by deuterium incorporation has been associated with nonresponse to PS consumption ; however , prospective studies that show this association have yet to be conducted .
OBJECTIVE	The goal was to test whether the lathosterol-to-cholesterol ratio ( L : C ratio ) , a surrogate marker of endogenous cholesterol synthesis , serves as an a priori predictor of cholesterol lowering in response to PS consumption .
METHODS	Sixty-three mildly hypercholesterolemic adults who were preselected as possessing either high endogenous cholesterol synthesis [ HS ; n = 24 ; L : C = 2.03 0.39 mol/mmol ( mean SD ) ] or low endogenous cholesterol synthesis ( LS ; n = 39 ; L : C = 0.99 0.28 mol/mmol ) on the basis of baseline L : C consumed 2 g PS/d or a placebo for 28 d with the use of a dual-center , single-blind , randomized crossover design .
METHODS	Plasma lipid and noncholesterol sterol concentrations were measured at the end of each phase .
RESULTS	PS consumption lowered total cholesterol ( TC ; -0.25 0.05 mmol/L ; P < 0.0001 ) and LDL cholesterol ( -0.17 0.04 mmol/L ; P < 0.0001 ) overall .
RESULTS	Specifically , LS individuals responded to PS treatment with a reduction in TC ( -0.40 0.07 mmol/L ; P < 0.0001 ) and LDL cholesterol ( -0.29 0.05 mmol/L ; P = 0.0002 ) , whereas HS individuals failed to show cholesterol lowering ( TC : -0.09 0.09 mmol/L ; P = 0.2843 ; LDL cholesterol : -0.05 0.07 mmol/L ; P = 0.4917 ) .
RESULTS	The odds of LS participants responding to PS consumption with cholesterol lowering better than the mean cholesterol lowering in all participants were 4.25 ( 95 % CI : 1.242 , 14.556 ; P = 0.0211 ) for TC and 3.36 ( 95 % CI : 1.112 , 10.161 ; P = 0.0317 ) for LDL cholesterol , which was higher than for HS participants .
CONCLUSIONS	The L : C ratio predicts the extent of reduction in circulating TC and LDL cholesterol in response to PS consumption .
CONCLUSIONS	Cholesterol synthesis assessment may thus have a use in identifying responders and nonresponders to PS therapy .

###24533515
BACKGROUND	Immunization quality improvement programs are often limited by the cost and inconvenience associated with delivering face-to-face consultations to primary care providers .
BACKGROUND	To investigate a more efficient mode of intervention delivery , we conducted a process evaluation that compared in-person consultations to those delivered via interactive webinar .
METHODS	The Centers for Disease Control and Prevention 's Assessment , Feedback , Incentives , and eXchange ( AFIX ) Program is an immunization quality improvement program implemented in all 50 states .
METHODS	In 2011 , we randomly assigned 61 high-volume primary care clinics in North Carolina to receive an in-person or webinar AFIX consultation focused on adolescent immunization .
METHODS	We used surveys of participating vaccine providers and expense tracking logs to evaluate delivery modes on participation , satisfaction , and cost .
METHODS	Clinics served 71,874 patients , ages 11 to 18 .
RESULTS	Clinics that received in-person and webinar consultations reported similar levels of participation on key programmatic activities with one exception : more webinar clinics reported improving documentation of previously administered , ` historical ' vaccine doses .
RESULTS	Both in-person and webinar clinics showed sustained improvement in confidence to use reminder/recall systems ( both p < 0.05 ) .
RESULTS	Participants rated delivery modes equally highly on satisfaction measures such as convenience ( mean = 4.6 of 5.0 ) .
RESULTS	Delivery cost per clinic was $ 152 for in-person consultations versus $ 100 for webinar consultations .
CONCLUSIONS	In-person and webinar delivery modes were both well received , but webinar AFIX consultations cost substantially less .
CONCLUSIONS	Interactive webinar delivery shows promise for considerably extending the reach of immunization quality improvement programs .
BACKGROUND	Clinicaltrials.gov , NCT01544764 .

###25733639
BACKGROUND	Recent evidence has indicated that flavanol consumption may have many health benefits in humans , including improved cognitive activities .
OBJECTIVE	The aim was to evaluate the effect of flavanol consumption on cognitive performance in cognitively intact elderly subjects .
METHODS	This was a double-blind , controlled , parallel-arm study conducted in 90 elderly individuals without clinical evidence of cognitive dysfunction who were randomly assigned to consume daily for 8 wk a drink containing 993 mg [ high flavanol ( HF ) ] , 520 mg [ intermediate flavanol ( IF ) ] , or 48 mg [ low flavanol ( LF ) ] cocoa flavanols ( CFs ) .
METHODS	Cognitive function was assessed at baseline and after 8 wk by using the Mini-Mental State Examination ( MMSE ) , the Trail Making Test ( TMT ) A and B , and the Verbal Fluency Test ( VFT ) .
RESULTS	The changes in MMSE score in response to the 3 different treatments were not different .
RESULTS	In contrast , there was a positive impact of the intervention on specific aspects of cognitive function .
RESULTS	Mean changes ( SEs ) in the time required to complete the TMT A and B after consumption of the HF ( -8.6 0.4 and -16.5 0.8 s , respectively ) and IF ( -6.7 0.5 and -14.2 0.5 s , respectively ) drinks significantly ( P < 0.0001 ) differed from that after consumption of the LF drinks ( -0.8 1.6 and -1.1 0.7 s , respectively ) .
RESULTS	Similarly , VFT scores significantly improved among all treatment groups , but the magnitude of improvement in the VFT score was significantly ( P < 0.0001 ) greater in the HF group ( 7.7 1.1 words/60 s ) than in the IF ( 3.6 1.2 words/60 s ) and LF ( 1.3 0.5 words/60 s ) groups .
RESULTS	Significantly different improvements in insulin resistance ( P < 0.0001 ) , blood pressure ( P < 0.0001 ) , and lipid peroxidation ( P = 0.001 ) were also observed for the HF and IF groups in comparison with the LF group .
RESULTS	Changes in insulin resistance explained 17 % of changes in composite z score ( partial r = 0.1703 , P < 0.0001 ) .
CONCLUSIONS	This dietary intervention study provides evidence that regular CF consumption can reduce some measures of age-related cognitive dysfunction , possibly through an improvement in insulin sensitivity .
CONCLUSIONS	These data suggest that the habitual intake of flavanols can support healthy cognitive function with age .

###24685369
BACKGROUND	Authors have reported better outcomes , by reducing surgical dissection for carpal tunnel syndromes requiring surgery .
BACKGROUND	Recently , a new sonographically guided technique for ultra minimally invasive ( Ultra-MIS ) carpal tunnel release ( CTR ) through 1mm incision has been described .
OBJECTIVE	We hypothesized that a clinical trial for comparing Ultra-MIS versus Mini-open Carpal Tunnel Release ( Mini-OCTR ) was feasible .
METHODS	To test our hypothesis , we conducted a pilot study for studying Ultra-MIS versus Mini-OCTR respectively performed through a 1mm or a 2 cm incision .
METHODS	We defined success if primary feasibility objectives ( safety and efficacy ) as well as secondary feasibility objectives ( recruitment rates , compliance , completion , treatment blinding , personnel resources and sample size calculation for the clinical trial ) could be matched .
METHODS	Score for Quick-DASH questionnaire at final follow-up was studied as the primary variable for the clinical trial .
METHODS	Turnover times were studied for assessing learning curve stability .
RESULTS	Forty patients were allotted .
RESULTS	Primary and secondary feasibility objectives were matched with the following occurrences : 70.2 % of eligible patients finally recruited ; 4.2 % of randomization refusals ; 26.6 patients/month recruited ; 100 % patients receiving a blinded treatment ; 97.5 % compliance and 100 % completion .
RESULTS	A sample size of 91 patients was calculated for clinical trial validation .
RESULTS	At final follow-up , preliminary results for Quick-Dash substantially favored Ultra-MIS over Mini-OCTR ( average 14.54 versus 7.39 ) and complication rates were lower for Ultra-MIS ( 5 % versus 20 % ) .
RESULTS	A stable learning curve was observed for both groups .
CONCLUSIONS	The clinical trial is feasible .
CONCLUSIONS	There is currently no evidence to contraindicate nor withhold the use of Ultra-MIS for CTR .
METHODS	III .

###24946636
OBJECTIVE	To investigate the effectiveness of polycystic ovary syndrome ( PCOS ) of damp-phlegm constitution treated with embedding therapy on back-shu points and front-mu points and needle-pricking therapy on Sifeng ( EX-UE 10 ) .
METHODS	Eighty-five patients were randomly divided into 2 groups of observation group ( 42 cases ) and control group ( 43 cases ) .
METHODS	Embedding therapy on back-shu points and front-mu points and needle-pricking therapy on Sifeng ( EX-UE 10 ) were applied to the observation group .
METHODS	Points such as Zhongwan ( CV 12 ) , Guanyuan ( CV 4 ) , Tianshu ( ST 25 ) , Zhangmen ( LR 13 ) , Jingmen ( GB 25 ) , Qimen ( LR 14 ) , Ganshu ( BL 18 ) , Weishu ( BL 21 ) , Pishu ( BL 20 ) , Shenshu ( BL 23 ) , Dachangshu ( BL 25 ) and Xiaochangshu ( BL 27 ) , etc. were adopted for embedding therapy .
METHODS	At the same time , needle-pricking therapy on Sifeng ( EX-UE 10 ) was also applied once a week .
METHODS	0.5 g metformin hydrochloride tablet was given to the control group , once a day for the first week , and twice a day from the second week .
METHODS	Estimation on therapeutic effect was made for both groups after 3 months treatment .
METHODS	Change of symptoms and signs scores , fasting insulin ( FINS ) , 2 hour insulin after meal ( 2hINS ) and insulin resistance index ( HOMA-IR ) of both groups before and after treatment were observed , and therapeutic effect estimated .
RESULTS	The total effective rate of the observation group is 97.6 % ( 41/42 ) , and that of the control group was 95.4 % ( 41/43 ) .
RESULTS	There was no significant difference between the two groups ( P > 0.05 ) .
RESULTS	Scores of symptoms and signs after treatment were significantly improved in both groups ( all P < 0.01 ) , and the observation group was better than the control group ( 7.01 + / -4.23 vs 8.47 + / -2.82 , P < 0.05 ) .
RESULTS	Compare with those before the treatment , FINS , 2hINS and HOMA-IR after the treatment were all decreased in both groups ( all P < 0.05 ) .
RESULTS	The comparison between the two groups showed that differences of FIN had no statistic significance ( P > 0.05 ) after the treatment , while both differences of 2hINS and HOMA-IR had statistic significance [ 2hlNS : ( 443.531 + / - 93.90 ) pmol/L vs ( 621.29 + / -93.87 ) pmol/L ; HOMA-IR : 4.88 + / -0.30 vs 5.06 + / -0.32 , both P < 0.05 ] .
RESULTS	The improvement of 2hINS and HOMA-IR in the observation group was better than that of the control group .
CONCLUSIONS	Treatment of PCOS of damp-phlegm constitution with embedding therapy on back-shu points and front-mu points and needle-pricking therapy on Sifeng ( EX-UE 10 ) have positive effect , which can effectively reduce the insulin resistance , meanwhile , reduce the side-effects of western medication .

###24734991
OBJECTIVE	To examine the use of handheld methodology to assess mechanical nociceptive threshold ( MNT ) on cows kept loose-housed .
METHODS	Prospective randomized partial cross-over experimental study .
METHODS	A one-factor ( test day ) design was used to evaluate MNT over time .
METHODS	One hundred and fifteen healthy , loose-housed Danish Holstein cattle .
METHODS	We evaluated intra-individual variation , inter-observer agreement and variation over time of MNT using two handheld devices and two stimulation sites .
METHODS	Mechanical , ramped stimulations were performed with an algometer ( 6.5 mm diameter steel probe , 0-10 .0 kgf ) or an electronic von Frey device ( plastic tip with diameter 0.8 mm , 0-1000 gf ) .
METHODS	Each cow received 5-6 consecutive stimulations within a 2 5 cm skin area on the dorsal or lateral aspect of the left third metatarsus until an avoidance reaction occurred .
METHODS	We investigated the difference in precision [ expressed as coefficient of variation ( CV ) ] between the combinations of devices and stimulation sites .
METHODS	The inter-observer agreement and the difference in MNT between test day 1 , 3 , 7 , 10 and 24 were investigated for selected combinations .
METHODS	Data were analysed in mixed models and Bland-Altman as relevant .
RESULTS	The CVs did not differ [ range 0.34-0 .52 ( p = 0.1 ) ] .
RESULTS	Difference between observers ( 95 % limits ) was 0.2 kgf ( 2.8 ) and 4 gf ( 369 ) for the algometer and von Frey device , respectively .
RESULTS	Mechanical nociceptive threshold increased from 361 on test day one to 495 gf on test day 24 ( p < 0.01 ) .
CONCLUSIONS	All methods showed a high degree of intra-individual variation , and no combination of device and stimulation site showed superior precision .
CONCLUSIONS	Mean difference between observers was low , and MNT was not consistent over time .
CONCLUSIONS	Further development of the methods is required before they can be used in research to investigate possible relations between claw lesions and hyperalgesia .

###24366401
BACKGROUND	We evaluated the effectiveness and cost-effectiveness of alternative interventions designed to promote mammography in safety-net settings .
METHODS	A three-arm , quasi-experimental evaluation was conducted among eight federally qualified health clinics in predominately rural Louisiana .
METHODS	Mammography screening efforts included : 1 ) enhanced care , 2 ) health literacy-informed education of patients , and 3 ) education plus nurse support .
METHODS	Outcomes included mammography screening completion within 6 months and incremental cost-effectiveness .
RESULTS	Overall , 1,181 female patients ages 40 and over who were eligible for routine mammography were recruited .
RESULTS	Baseline screening rates were < 10 % .
RESULTS	Post intervention screening rates were 55.7 % with enhanced care , 51.8 % with health literacy-informed education and 65.8 % with education and nurse support .
RESULTS	After adjusting for race , marital status , self-efficacy and literacy , patients receiving health-literacy informed education were not more likely to complete mammographic screening than those receiving enhanced care ; those additionally receiving nurse support were 1.37-fold more likely to complete mammographic screening than those receiving the brief education ( 95 % Confidence Interval 1.08-1 .74 , p = 0.01 ) .
RESULTS	The incremental cost per additional women screened was $ 2,457 for literacy-informed education with nurse support over literacy-informed education alone .
CONCLUSIONS	Mammography rates were increased substantially over existing baseline rates in all three arms with the educational initiative , with nurse support and follow-up being the most effective option .
CONCLUSIONS	However , it is not likely to be cost-effective or affordable in resource-limited clinics .

###25322163
BACKGROUND	Ingrown toenail ( IGTN ) is a common problem that can affect walking and can preclude daily activities .
OBJECTIVE	To compare the safety and efficacy of lateral nail avulsion with phenolization ( LNAP ) versus sleeve ( nail tube splinting ) surgical techniques in the treatment of IGTN .
METHODS	Patients older than 15 years with IGTN were included .
METHODS	Patients were evaluated for the duration and severity of pain , drainage , complete healing periods , recurrence rate , and overall success rate .
METHODS	Assessment was performed at baseline and at 1 , 3 , and 6 months .
METHODS	Complications were noted .
RESULTS	A total of 53 patients , including 46 males ( 87.8 % ) , were treated .
RESULTS	The mean age was 27.7 1.3 years .
RESULTS	Thirty patients underwent LNAP , and 23 underwent sleeve methods .
RESULTS	The surgical success rate , defined as > 90 % improvement , was found to be 80 % to 82 % for both groups .
RESULTS	Recurrence was observed in only 1 patient of each group .
RESULTS	None of the observed differences in healing , discharge , and recovery were statistically significant except in reporting shoe-wear discomfort , which was shorter in the sleeve group ( p < .05 ) .
RESULTS	Postoperative pain experience was also noted to be less in the sleeve group ( p = .057 ) .
CONCLUSIONS	Both methods , LNAP and sleeve , seem to be equally effective for the treatment of IGTNs .
CONCLUSIONS	Postoperative shoe-wearing discomfort and pain are shorter when the sleeve method was used .

###25163906
BACKGROUND	Cilengitide is a selective v3 and v5 integrin inhibitor .
BACKGROUND	Data from phase 2 trials suggest that it has antitumour activity as a single agent in recurrent glioblastoma and in combination with standard temozolomide chemoradiotherapy in newly diagnosed glioblastoma ( particularly in tumours with methylated MGMT promoter ) .
BACKGROUND	We aimed to assess cilengitide combined with temozolomide chemoradiotherapy in patients with newly diagnosed glioblastoma with methylated MGMT promoter .
METHODS	In this multicentre , open-label , phase 3 study , we investigated the efficacy of cilengitide in patients from 146 study sites in 25 countries .
METHODS	Eligible patients ( newly diagnosed , histologically proven supratentorial glioblastoma , methylated MGMT promoter , and age 18 years ) were stratified for prognostic Radiation Therapy Oncology Group recursive partitioning analysis class and geographic region and centrally randomised in a 1:1 ratio with interactive voice response system to receive temozolomide chemoradiotherapy with cilengitide 2000 mg intravenously twice weekly ( cilengitide group ) or temozolomide chemoradiotherapy alone ( control group ) .
METHODS	Patients and investigators were unmasked to treatment allocation .
METHODS	Maintenance temozolomide was given for up to six cycles , and cilengitide was given for up to 18 months or until disease progression or unacceptable toxic effects .
METHODS	The primary endpoint was overall survival .
METHODS	We analysed survival outcomes by intention to treat .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00689221 .
RESULTS	Overall , 3471 patients were screened .
RESULTS	Of these patients , 3060 had tumour MGMT status tested ; 926 patients had a methylated MGMT promoter , and 545 were randomly assigned to the cilengitide ( n = 272 ) or control groups ( n = 273 ) between Oct 31 , 2008 , and May 12 , 2011 .
RESULTS	Median overall survival was 263 months ( 95 % CI 238-288 ) in the cilengitide group and 263 months ( 239-347 ) in the control group ( hazard ratio 102 , 95 % CI 081-129 , p = 086 ) .
RESULTS	None of the predefined clinical subgroups showed a benefit from cilengitide .
RESULTS	We noted no overall additional toxic effects with cilengitide treatment .
RESULTS	The most commonly reported adverse events of grade 3 or worse in the safety population were lymphopenia ( 31 [ 12 % ] in the cilengitide group vs 26 [ 10 % ] in the control group ) , thrombocytopenia ( 28 [ 11 % ] vs 46 [ 18 % ] ) , neutropenia ( 19 [ 7 % ] vs 24 [ 9 % ] ) , leucopenia ( 18 [ 7 % ] vs 20 [ 8 % ] ) , and convulsion ( 14 [ 5 % ] vs 15 [ 6 % ] ) .
CONCLUSIONS	The addition of cilengitide to temozolomide chemoradiotherapy did not improve outcomes ; cilengitide will not be further developed as an anticancer drug .
CONCLUSIONS	Nevertheless , integrins remain a potential treatment target for glioblastoma .
BACKGROUND	Merck KGaA , Darmstadt , Germany .

###24948549
BACKGROUND	The Cappella Sideguard ( CS ) sidebranch stent is a self-expanding , thin-strut , nitinol device with anatomic flaring at the sidebranch ostium designed to treat bifurcation lesions .
OBJECTIVE	To evaluate the mechanism of long-term lumen patency of the novel , self-expanding CS sidebranch stent compared with a balloon-expandable stent in the main vessel .
METHODS	We performed intravascular ultrasound postintervention and at follow-up in 24 CS stents and in 28 balloon-expandable drug-eluting stents deployed in the corresponding main vessel .
METHODS	Thirteen patients also had optical coherence tomography ( OCT ) at follow-up to evaluate neointimal hyperplasia and strut coverage .
RESULTS	CS stent area at the sidebranch carina increased significantly from 3.8 1.2 mm ( 2 ) postintervention to 4.6 1.2 mm ( 2 ) at follow-up ( P < 0.001 ) , resulting in no change in lumen area ( 3.8 1.2 mm ( 2 ) to 3.7 1.2 mm ( 2 ) , P = 0.72 ) despite a neointimal area at follow-up of 0.9 0.8 mm ( 2 ) .
RESULTS	Volumetric changes were similar , and the distribution of neointimal hyperplasia peaked 1-2 mm distal to the carina .
RESULTS	Change of lumen volume inversely correlated to the neointimal volume ( R = -0.48 , P < 0.001 ) , but correlated positively to the change in stent volume ( R = 0.52 , P < 0.0001 ) .
RESULTS	By OCT , most CS struts were covered ( 100 % [ 98.9 , 100 ] ) at the bifurcation site , whereas 61 % of floating DES struts that crossed the sidebranch were covered by smooth tissue with a similar texture compared with neointima .
CONCLUSIONS	Although neointimal hyperplasia accumulates within the CS stent mainly 1-2 mm distal to the carina , the self-expanding CS stent may be effective in maintaining an adequate patency in the sidebranch by continued stent expansion noted at follow-up .

###24389401
OBJECTIVE	To examine upper limb physical function and adverse effects after axillary lymph node dissection ( ALND ) and sentinel lymph node biopsy ( SLNB ) in patients with breast cancer to identify impairments that can inform rehabilitation strategies .
METHODS	Prospective longitudinal cohort .
METHODS	Upper limb measurements were studied preoperatively and 2.5 years after breast cancer treatment .
METHODS	Hospital setting .
METHODS	Two groups of patients with early-stage primary breast cancer ( N = 391 ) : the ALND surgery group ( mean age , 5510y ) and the SLNB group ( mean age , 5710y ) .
METHODS	Not applicable .
METHODS	Arm lymphedema ( 10 % increased arm volume relative to control arm volume ) , grip strength ( in kilograms ) , shoulder mobility , pain intensity during isometric shoulder abduction ( on a 100-mm visual analog scale ) , and body mass index ( kg/m ( 2 ) ) .
METHODS	Parametric/nonparametric tests were used for hypothesized changes and differences , and regression analysis was used for confounding factors .
RESULTS	We observed more adverse effects in women treated with ALND than with SLNB after 2.5 years ( P < .05 ) : arm lymphedema ( 17 % vs 3 % ) , grip strength reduction ( 12 % vs 2 % ) , and shoulder abduction-provoked pain ( increase of 6 % vs decrease of 50 % ) .
RESULTS	The adverse effects were similar for affected and control upper limbs for all outcomes except arm lymphedema , which occurred only on the affected side .
CONCLUSIONS	Adverse effects in both affected and control/unaffected upper limb were observed after 2.5-year follow-up in both ALND and SLNB groups , but a higher prevalence was observed in the ALND group .
CONCLUSIONS	Thus , women going through ALND surgery may benefit from further postoperative physical therapy , including resistance and strength exercise , focusing on pain management .

###25150285
OBJECTIVE	The aim of this study was to investigate whether directional steering through a novel 32-contact electrode is safe and can modulate the thresholds for beneficial and side effects of stimulation .
METHODS	The study is a single-center , performance and safety study .
METHODS	Double-blind intraoperative evaluations of the thresholds for therapeutic benefit and for side effects were performed in 8 patients with Parkinson disease while stimulating in randomized order in spherical mode and in 4 different steering modes with the 32-contact electrode , and in monopolar mode with a commercial electrode .
METHODS	In addition , simultaneous recordings of local field potentials through all 32 contacts were performed .
RESULTS	There were no adverse events related to the experimental device .
RESULTS	For 13 of 15 side effects ( 87 % ) , the threshold could be increased by 1 mA while steering in at least one direction in comparison to conventional spherical stimulation , thereby increasing the therapeutic window by up to 1.5 mA .
RESULTS	Recording local field potentials through all 32 electrode contacts yielded spatiotemporal information on pathologic neuronal activity .
CONCLUSIONS	Controlled steering of current through the brain may improve the effectiveness of deep brain stimulation ( DBS ) , allow for novel applications , and provide a tool to better explore pathophysiologic activity in the brain .
METHODS	This study provides Class IV evidence that for patients with Parkinson disease , steering DBS current is well tolerated , increases the threshold for side effects , and may improve the therapeutic window of subthalamic nucleus DBS as compared with current standard spherical stimulation .

###25597173
OBJECTIVE	To explore the efficacy and safety of vitamin D ( VD ) in the treatment of idiopathic oligoasthenozoospermia .
METHODS	This study included 86 infertile men with idiopathic oligoasthenozoospermia , who were randomized to a VD and a control group of equal number , the former given oral VD 200 IU/d and calcium 600 mg/d , qd , while the latter administered oral vitamin E 100 mg and vitamin C 100 mg , tid .
METHODS	After 3 months of medication , we compared the semen parameters , adverse reactions , and pregnancy rate between the two groups .
RESULTS	After medication , the count of progressively motile sperm per ejaculate was increased from ( 9.82 3.72 ) x 10 ( 6 ) to ( 21.47 6.52 ) x 10 ( 6 ) ( P < 0.05 ) and the proportion of progressively motile sperm from ( 18.41 9.82 ) % to ( 28.27 4.47 ) % ( P < 0.05 ) in the VD group .
RESULTS	In comparison , the count of progressively motile sperm per ejaculate was elevated from ( 9.51 6.31 ) x 10 ( 6 ) to ( 12.36 4.43 ) x 10 ( 6 ) ( P > 0.05 ) and the proportion of progressively motile sperm from ( 17.79 5.25 ) % to ( 21.35 2.41 ) % ( P > 0.05 ) in the control group .
RESULTS	Pregnancy was achieved in 7 cases ( 16.3 % ) in the VD group , but only lease ( 2.3 % ) in the control ( P < 0.05 ) .
RESULTS	No adverse reactions were observed in either of the groups .
CONCLUSIONS	Vitamin D , as a safe option for the treatment of idiopathic oligoasthenozoospermia , can effectively improve the semen quality , especially the progressive sperm motility of the patient .

###25403347
OBJECTIVE	To evaluate the cost-effectiveness of medical yoga as an early intervention compared with evidence-based exercise therapy and self-care advice for non-specific low back pain .
METHODS	Randomized controlled trial with a cost-effectiveness analysis .
METHODS	A total of 159 participants randomized into the medical yoga group ( n = 52 ) , the exercise therapy group ( n = 52 ) and the self-care advice group ( n = 55 ) .
METHODS	The health outcome measure EQ-5D was applied to measure quality of life data combined with cost data collected from treatment groups from baseline to 12 months follow-up .
METHODS	Outcome measure was health-related quality of life ( HRQL ) .
METHODS	Incremental cost per quality adjusted life year ( QALY ) was also calculated .
METHODS	Cost-effectiveness analysis was conducted primarily from the societal and employer perspectives .
RESULTS	Medical yoga is cost-effective compared with self-care advice if an employer considers the significant improvement in the HRQL of an employee with low back pain justifies the additional cost of treatment ( i.e. in this study EUR 150 ) .
RESULTS	From a societal perspective , medical yoga is a cost-effective treatment compared with exercise therapy and self-care advice if an additional QALY is worth EUR 11,500 .
RESULTS	Sensitivity analysis suggests that medical yoga is more cost-effective than its alternatives .
CONCLUSIONS	Six weeks of uninterrupted medical yoga thera-py is a cost-effective early intervention for non-specific low back pain , when treatment recommendations are adhered to .

###26047975
BACKGROUND	Dyslipidaemia remains a significant risk factor for cardiovascular disease and additional lipid-modifying treatments are warranted to further decrease the cardiovascular disease burden .
BACKGROUND	We assessed the safety , tolerability and efficacy of a novel cholesterol esterase transfer protein ( CETP ) inhibitor TA-8995 in patients with mild dyslipidaemia .
METHODS	In this randomised , double-blind , placebo-controlled , parallel-group phase 2 trial , we recruited patients ( aged 18-75 years ) from 17 sites ( hospitals and independent clinical research organisations ) in the Netherlands and Denmark with fasting LDL cholesterol levels between 25 mmol/L and 45 mmol/L , HDL cholesterol levels between 08 and 18 mmol/L and triglyceride levels below 45 mmol/L after washout of lipid-lowering treatments .
METHODS	Patients were randomly allocated ( 1:1 ) by a computer-generated randomisation schedule to receive one of the following nine treatments : a once a day dose of 1 mg , 25 mg , 5 mg , or 10 mg TA-8995 or matching placebo ; 10 mg TA-8995 plus 20 mg atorvastatin ; 10 mg TA-8995 plus 10 mg rosuvastatin or 20 mg atorvastatin or 10 mg rosuvastatin alone .
METHODS	We overencapsulated statins to achieve masking .
METHODS	The primary outcome was percentage change in LDL cholesterol and HDL cholesterol from baseline at week 12 , analysed by intention to treat .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01970215 .
RESULTS	Between Aug 15 , 2013 , and Jan 10 , 2014 , 364 patients were enrolled .
RESULTS	At week 12 , LDL cholesterol levels were reduced by 274 % in patients assigned to the 1 mg dose , 327 % in patients given the 25 mg dose , 453 % in those given the 5 mg dose , and 453 % in those given the 10 mg dose ( p < 00001 ) .
RESULTS	LDL cholesterol levels were reduced by 682 % in patients given 10 mg TA-8995 plus atorvastatin , and by 633 % in patients given rosuvastatin plus 10 mg TA-8995 ( p < 00001 ) .
RESULTS	A daily dose of 1 mg TA-8995 increased HDL cholesterol levels by 758 % , 25 mg by 1243 % , 5 mg by 1571 % , and 10 mg dose by 1790 % ( p < 00001 ) .
RESULTS	In patients receiving 10 mg TA-8995 and 20 mg atorvastatin HDL cholesterol levels increased by 1521 % and in patients receiving 10 mg TA-8995 and 10 mg rosuvastatin by 1575 % .
RESULTS	We recorded no serious adverse events or signs of liver or muscle toxic effects .
CONCLUSIONS	TA-8995 , a novel CETP inhibitor , is well tolerated and has beneficial effects on lipids and apolipoproteins in patients with mild dyslipidaemia .
CONCLUSIONS	A cardiovascular disease outcome trial is needed to translate these effects into a reduction of cardiovascular disease events .
BACKGROUND	Dezima .

###25303029
OBJECTIVE	Addition of viscous fiber to foods has been shown to significantly reduce postprandial glucose excursions .
OBJECTIVE	However , palatability issues and the variability in effectiveness due to different methods of administration in food limits it use .
OBJECTIVE	This study explores the effectiveness of a viscous fiber blend ( VFB ) in lowering postprandial glycemia using different methods of incorporation .
METHODS	Two acute , randomized , controlled studies were undertaken : Study 1 : Twelve healthy individuals ( mean SD , age : 36 13years , body mass index [ BMI ] : 27 4kg/m ( 2 ) ) consumed 8 different breakfasts .
METHODS	All meals consisted of 50g of available carbohydrate from white bread ( WB ) and 10g margarine .
METHODS	Zero , 1 , 2 , or 4g of the VFB was baked into WB or mixed with the margarine .
METHODS	Study 2 : Thirteen healthy individuals ( mean SD , age : 39 17years , BMI : 25 5kg/m ( 2 ) ) consumed 6 test meals , consisting of 50g of available carbohydrate from WB .
METHODS	Six capsules containing either cornstarch or VFB were taken at 4 different time points during the glucose tolerance test .
METHODS	After obtaining a fasting finger-prick blood sample , volunteers consumed the test meal over a 10-minute period .
METHODS	Additional blood samples were taken at 15 , 30 , 45 , 60 , 90 , and 120 minutes from the start of the meal .
METHODS	For study 2 , an additional fasting sample was obtained at -30 minutes .
RESULTS	Study 1 : Irrespective of VFB dose , glucose levels were lower at 30 and 45 minutes when VFB was mixed into the margarine compared to the control ( p < 0.05 ) .
RESULTS	Incremental areas under the curve were significantly lower compared to control when 4g of VFB was mixed into the margarine .
RESULTS	Study 2 : There was no effect of the VFB on postprandial glucose levels when administered in capsules .
CONCLUSIONS	Incorporation of VFB into margarine was more effective in lowering postprandial glycemia than when the VFB was baked into bread and no effect when given in capsules .

###24799181
OBJECTIVE	Non-surgical therapies are needed to reduce the rate of progression of low-grade cervical intraepithelial neoplasia ( CIN 1 ) to high grade CIN ( CIN 2/3 ) .
OBJECTIVE	The aim of this study was to assess the efficacy and safety of hexaminolevulinate ( HAL ) photodynamic therapy ( PDT ) in the treatment of patients with CIN 1 .
METHODS	This phase IIa prospective double-blind study randomized patients with CIN 1 into three groups : HAL vaginal suppository , placebo vaginal suppository or follow-up only .
METHODS	Patients in the first two groups received HAL or placebo suppositories 5hours before illumination with 50J/cm ( 2 ) red coherent light ( 633nm ) using a special light catheter .
METHODS	All patients had a follow up including colposcopy , cytology and human papilloma virus ( HPV ) testing 3 and 6 months and additional biopsy 6 months after PDT .
METHODS	The main outcome measure was efficacy , defined as complete histologic remission 6 months after PDT .
METHODS	Secondary outcomes were histologic remission 3 months and HPV eradication 6 months after first PDT .
RESULTS	Seventy patients were randomized : 47 to HAL , 12 to placebo , 11 to follow up only .
RESULTS	After 6 months CIN lesions had cleared in 57 % of patients in the HAL-PDT group compared to 25 % in the combined control group ( per protocol population , P = 0.04 ) .
RESULTS	Twenty-six patients ( 37 % ) reported 44 adverse events ( AEs ) , of which 40 were mild or moderate .
RESULTS	Nineteen treatment-related AEs were reported by 15 patients ( 32 % ) in the HAL PDT group , one in the placebo PDT group ( 8 % ) , and none in the follow-up group .
RESULTS	The most common adverse events were local discomfort including mild pain/cramping ( 11 ) and leucorrhoea ( 2 ) .
CONCLUSIONS	HAL PDT shows a favorable efficacy and safety profile and represents a promising alternative to observation and surgical procedures in patients with CIN 1 .

###25146587
BACKGROUND	Low back pain is a common and disabling condition leading to large health service and societal costs .
BACKGROUND	Although there are several treatment options for back pain little is known about how to improve patient choice in treatment selection .
BACKGROUND	The purpose of this study was to pilot a decision support package to help people choose between low back pain treatments .
METHODS	This was a single-centred pilot cluster randomised controlled trial conducted in a community physiotherapy service .
METHODS	We included adults with non-specific low back pain referred for physiotherapy .
METHODS	Intervention participants were sent an information booklet prior to their first consultation .
METHODS	Intervention physiotherapists were trained to enhance their skills in shared informed decision making .
METHODS	Those in the control arm received care as usual .
METHODS	The primary outcome was satisfaction with the treatment received at four months using a five-point Likert Scale dichotomised into `` satisfaction '' ( very satisfied or somewhat satisfied ) and `` non-satisfaction '' ( neither satisfied nor dissatisfied , somewhat dissatisfied or very dissatisfied ) .
RESULTS	We recruited 148 participants .
RESULTS	In the control arm 67 % of participants were satisfied with their treatment and in the intervention arm 53 % .
RESULTS	The adjusted relative risk of being satisfied was 1.28 ( 95 % confidence interval 0.79 to 2.09 ) .
RESULTS	For most secondary outcomes the trend was towards worse outcomes in the intervention group .
RESULTS	For one measure ; the Roland Morris Disability Questionnaire , this difference was clinically important ( 2.27 , 95 % confidence interval 0.08 to 4.47 ) .
RESULTS	Mean healthcare costs were slightly lower ( 38 saving per patient ) within the intervention arm but health outcomes were also less favourable ( 0.02 fewer QALYs ) ; the estimated probability that the intervention would be cost-effective at an incremental threshold of 20,000 per QALY was 16 % .
CONCLUSIONS	We did not find that this decision support package improved satisfaction with treatment ; it may have had a substantial negative effect on clinical outcome , and is very unlikely to prove cost-effective .
CONCLUSIONS	That a decision support package might have a clinically important detrimental effect is of concern .
CONCLUSIONS	To our knowledge this has not been observed previously .
CONCLUSIONS	Decision support packages should be formally tested for clinical and cost-effectiveness , and safety before implementation .
BACKGROUND	Current Controlled Trials ISRCTN46035546 registered on 11/02/10 .

###24660759
BACKGROUND	Promising clinical outcomes have been reported with the combination of enamel matrix derivative ( EMD ) and allograft materials .
BACKGROUND	Direct comparison between EMD with a freeze-dried bone allograft ( FDBA ) and a demineralized FDBA ( DFDBA ) was evaluated in one case series study .
BACKGROUND	To date , no randomized controlled trial has been reported .
BACKGROUND	Therefore , a well-controlled randomized clinical trial was conducted to determine the relative efficacy of EMD/FDBA versus EMD/DFDBA when managing intrabony defects .
METHODS	A randomized parallel trial was conducted in a private practice from April 2004 to October 2011 .
METHODS	Sixty-nine patients were randomly assigned to one of three groups : EMD/FDBA ( EF ) intervention group ( n = 23 ) , EMD/DFDBA ( ED ) intervention group ( n = 23 ) , and EMD alone without graft material ( E ) as a negative control group ( n = 23 ) .
METHODS	All of the grafting material had minocycline added .
METHODS	Each patient had an intrabony defect .
METHODS	The primary outcomes were the absolute change in probing depth ( PD ) reduction and clinical attachment level ( CAL ) gain from baseline to 1 - and 3-year follow-up .
METHODS	Intrabony defects were surgically treated with EMD/FDBA , EMD/DFDBA , or EMD alone .
RESULTS	Sixty-seven patients ( EF , n = 21 : ED , n = 23 ; E , n = 23 ) were analyzed .
RESULTS	All groups demonstrated significant improvement in PD reduction and CAL gain from baseline .
RESULTS	The changes for PD were as follows ( mm , 95 % confidence interval [ CI ] ) : at 1 year : EF ( 4.4 mm , 4.0 to 4.7 ) , ED ( 3.7 mm , 3.4 to 4.0 ) , and E ( control ) ( 3.3 mm , 3.0 to 3.6 ) ; at 3 years : EF ( 4.4 mm , 4.1 to 4.8 ) , ED ( 3.7 mm , 3.4 to 4.0 ) , and E ( 3.1 mm , 2.8 to 3.4 ) .
RESULTS	The changes for CAL were as follows ( mm , 95 % CI ) : at 1 year : EF ( 4.1 mm , 3.8 to 4.5 ) , ED ( 3.5 mm , 3.0 to 4.0 ) , and E ( 3.0 mm , 2.5 to 3.6 ) ; at 3 years : EF ( 4.2 mm , 3.7 to 4.7 ) , ED ( 3.6 mm , 3.1 to 4.1 ) , and E ( 3.0 mm , 2.5 to 3.5 ) .
RESULTS	The intervention groups ( EF and ED ) showed better treatment outcomes than the control group at 1 and 3 years .
RESULTS	Statistically , the two bone-graft groups were not significantly different from each other at 1 and 3 years .
CONCLUSIONS	Both EMD/FDBA and EMD/DFDBA interventions resulted in greater soft tissue improvement at 1 and 3 years of follow-up compared to EMD alone .
CONCLUSIONS	Both graft materials worked well in managing deep intrabony defects when combined with EMD .

###25311633
OBJECTIVE	To test the hypothesis that chocolate consumption is associated with a lower risk of heart failure ( HF ) .
RESULTS	We prospectively studied 20 278 men from the Physicians ' Health Study .
RESULTS	Chocolate consumption was assessed between 1999 and 2002 via a self-administered food frequency questionnaire and HF was ascertained through annual follow-up questionnaires with validation in a subsample .
RESULTS	We used Cox regression to estimate multivariable adjusted relative risk of HF .
RESULTS	During a mean follow-up of 9.3 years there were 876 new cases of HF .
RESULTS	The mean age at baseline was 66.49.2 years .
RESULTS	Hazard ratios [ 95 % confidence intervals ( CI ) ] for HF were 1.0 ( ref ) , 0.86 ( 0.72-1 .03 ) , 0.80 ( 0.66-0 .98 ) , 0.92 ( 0.74-1 .13 ) , and 0.82 ( 0.63-1 .07 ) , for chocolate consumption of less than 1/month , 1-3 / week , 2-4 / week , and 5 + / week , respectively , after adjusting for age , body mass index ( BMI ) , smoking , alcohol , exercise , energy intake , and history of atrial fibrillation ( P for quadratic trend = 0.62 ) .
RESULTS	In a secondary analysis , chocolate consumption was inversely associated with risk of HF in men whose BMI was < 25kg/m ( 2 ) [ HR ( 95 % CI ) = 0.59 ( 0.37-0 .94 ) for consumption of 5 + servings/week , P for linear trend = 0.03 ) but not in those with BMI of 25 + kg/m ( 2 ) [ HR ( 95 % CI ) = 1.01 ( 0.73-1 .39 ) , P for linear trend = 0.42 , P for interaction = 0.17 ) .
CONCLUSIONS	Our data suggest that moderate consumption of chocolate might be associated with a lower risk of HF in male physicians .

###24344783
OBJECTIVE	To assess the cardiovascular changes of a continuous rate infusion of lidocaine in calves anesthetized with xylazine , midazolam , ketamine and isoflurane during mechanical ventilation .
METHODS	Prospective , randomized , cross-over , experimental trial .
METHODS	A total of eight , healthy , male Holstein calves , aged 10 1 months and weighing 114 11 kg were included in the study .
METHODS	Calves were administered xylazine followed by ketamine and midazolam , orotracheal intubation and maintenance on isoflurane ( 1.3 % ) using mechanical ventilation .
METHODS	Forty minutes after induction , lidocaine ( 2 mg kg bolus ) or an equivalent volume of saline ( 0.9 % ) was administered IV followed by a continuous rate infusion ( 100 g kg minute ) of lidocaine ( treatment L ) or saline ( treatment C ) .
METHODS	Heart rate ( HR ) , systolic , diastolic and mean arterial pressures ( SAP , DAP and MAP ) , central venous pressure ( CVP ) , mean pulmonary arterial pressure ( mPAP ) , pulmonary arterial occlusion pressure ( PAOP ) , cardiac output , end-tidal carbon dioxide ( Pe'CO 2 ) and core temperature ( CT ) were recorded before lidocaine or saline administration ( Baseline ) and at 20-minute intervals ( T20-T80 ) .
METHODS	Plasma concentrations of lidocaine were measured in treatment L.
RESULTS	The HR was significantly lower in treatment L compared with treatment C.
RESULTS	There was no difference between the treatments with regards to SAP , DAP , MAP and SVRI .
RESULTS	CI was significantly lower at T60 in treatment L when compared with treatment C. PAOP and CVP increased significantly at all times compared with Baseline in treatment L.
RESULTS	There was no significant difference between times within each treatment and between treatments with regards to other measured variables .
RESULTS	Plasma concentrations of lidocaine ranged from 1.85 to 2.06 g mL during the CRI .
CONCLUSIONS	At the studied rate , lidocaine causes a decrease in heart rate which is unlikely to be of clinical significance in healthy animals , but could be a concern in compromised animals .

###24307502
OBJECTIVE	Antimicrobial prophylaxis is still a matter of debate in ear surgeries .
OBJECTIVE	Previous studies have focused on prophylaxis in middle ear surgery alone without inclusion of mastoidectomy .
OBJECTIVE	We therefore investigated efficacy of two regimes of antimicrobial prophylaxis in tympanoplasty with cortical mastoidectomy done for mild middle ear disease in chronic otitis media .
METHODS	Prospective , randomized , controlled , double-blind study .
METHODS	Patients undergoing tympanoplasty with cortical mastoidectomy were included and randomized into two study groups .
METHODS	The group I patients received parenteral perioperative antimicrobials ; only group II patients received additional extended oral antimicrobials for 8 days more postoperatively .
METHODS	Primary outcomes evaluated were postaural wound infection and graft success , assessed weekly until 1 month .
METHODS	Adverse events and length of hospital stay were evaluated as secondary outcome .
RESULTS	Seventy-eight patients were randomized into group I ( n = 39 ) and group II ( n = 39 ) .
RESULTS	The two groups showed no difference in wound infection rate .
RESULTS	The graft success rate in both the group was comparable ( 94.87 % in group I and 97.44 % in group II , respectively ; P = 1.00 ) .
RESULTS	The length of hospital stay was significantly longer ( P = 0.00001 ) in group II ( 3.05 [ 0.72 ] , mean [ SD ] ) as compared to group I ( 2.36 [ 0.49 ] ) .
RESULTS	During the first postoperative week , a significantly higher incidence of gastrointestinal disturbances were observed in group II ( 19 [ 48.72 % ] as compared to 1 [ 2.56 % ] in group I , P = 0.00001 ) .
CONCLUSIONS	The present study shows that there is no need of extended antimicrobial prophylaxis for tympanoplasty with cortical mastoidectomy done for mild middle ear disease .
CONCLUSIONS	An indiscriminate use of antimicrobials may lead to increase incidence of adverse events and prolonged hospital stay .
METHODS	1b .

###24895810
OBJECTIVE	Acute on chronic liver failure ( AoCLF ) is associated with a high mortality rate .
OBJECTIVE	Plasma exchange ( PE ) is useful to bridge AoCLF patients to liver transplantation .
OBJECTIVE	The aim of this study was to assess the effects of PE on plasma ammonia levels ( PAL ) in AoCLF patients .
METHODS	Seventy patients with AoCLF in 2 groups ( PE plus standard medical treatment group , n = 32 ; and standard medical treatment group , n = 38 ) were enrolled in study .
METHODS	PAL was detected on admission and on days 7 , 14 , 21 , and 30 during hospitalization .
RESULTS	All AoCLF patients showed PAL more than the upper limit of the normal range .
RESULTS	More dramatic decreased in the PE survivors ( form 116.8 + / - 36.3 to 44.8 + / - 16.3 , p < 0.01 ) than the medical survivors ( form 105.7 + / - 30.2 to 57.1 + / - 20.3 , p < 0.05 ) after 30 days of treatment .
RESULTS	Furthermore , PAL after medical treatment were still higher than those of PE treatment in the survivors ( 57.1 + / - 20.3 vs. 44.8 + / - 16.3 , p < 0.05 ) .
RESULTS	Among the non-survivors in the medical group , PAL remained at high levels throughout the examination period .
RESULTS	Importantly , an increased PAL associated with high mortality and reduced survival time of AoCLF patients .
CONCLUSIONS	Ammonia may be important in the pathogenesis of the AoCLF and PE may represent a reliable hepatic support device for AoCLF .

###25601014
OBJECTIVE	In Lynch syndrome , flat and diminutive adenomas are particularly prone to malignant transformation , but they can be missed by standard colonoscopy .
OBJECTIVE	It is not known whether chromocolonoscopy is able to detect more adenomas than standard colonoscopy in patients with Lynch syndrome .
METHODS	We conducted a prospective , multicenter , randomized trial to compare standard colonoscopy with standard colonoscopy followed by pancolonic chromoscopy with indigo carmine in patients with a proven germline mutation in a mismatch-repair gene related to Lynch syndrome and who were undergoing screening or surveillance colonoscopy .
METHODS	Standard colonoscopy was used first to detect visible lesions .
METHODS	Colonoscopy with chromoscopy was then performed by a second gastroenterologist ( blinded to the findings of the first colonoscopy ) to detect additional lesions .
METHODS	The primary end point was the number of patients in whom at least one adenoma was detected .
RESULTS	A total of 78 eligible patients ( median age , 45 years ) were enrolled at 10 centers from July 2008 to August 2009 .
RESULTS	Significantly more patients with at least one adenoma were identified by chromocolonoscopy ( 32/78 ( 41 % ) ) than by standard colonoscopy ( 18/78 ( 23 % ) ; P < 0.001 ) .
RESULTS	The percentage of patients in whom at least one additional adenoma was detected during the chromoscopy was 31 % ( 24/78 ) .
RESULTS	Overall , chromocolonoscopy plus colonoscopy detected a total of 55 adenomas in 32 patients ( mean number of adenomas detected per patient : 0.7 vs. standard colonoscopy alone : 0.3 ; P < 0.001 ) .
CONCLUSIONS	The results support the proposition that chromocolonoscopy may significantly improve the detection rate of colorectal adenomas in patients undergoing screening or surveillance colonoscopy for Lynch syndrome .

###25728891
BACKGROUND	Several studies suggest that surgical manipulation of the intestine and increased intra-abdominal pressure promotes bacterial translocation ( BT ) .
BACKGROUND	This prospective randomized study has investigated the effect of surgery on BT in patients undergoing elective colectomy for colon cancer by comparing the laparoscopic with the open approach .
METHODS	One hundred nineteen consecutive patients underwent colectomy for colon cancer : 59 cases underwent open resection and 60 cases underwent laparoscopic resection .
METHODS	For bacterial identification , tissue samples were taken from the liver , spleen , and mesenteric lymph nodes .
RESULTS	The incidence of BT increased in laparoscopic and open group after bowel mobilization ( prior to ligation of the vascular pedicle ) , compared with the before mobilization ( P < .05 ) .
RESULTS	There was not a statistically significant difference in BT value between the 2 groups .
CONCLUSIONS	BT increase was observed during the open and laparoscopic resection for colon cancer , without significant statistical difference between the 2 groups .

###25516405
OBJECTIVE	To investigate the effectiveness of exercise as treatment for vasomotor menopausal symptoms .
METHODS	Three-group randomised controlled trial , two exercise interventions and a control group .
METHODS	Primary Care , West Midlands UK .
METHODS	Perimenopausal and postmenopausal women experiencing at least five hot flushes/night sweats per day and not taken MHT in previous 3 months were recruited from 23 general practices .
METHODS	Participants in both exercise interventions groups were offered two face-to-face consultations with a physical activity facilitator to support engagement in regular exercise .
METHODS	In addition , one exercise group received a menopause-specific information DVD and written materials to encourage regular exercise and the other exercise group was offered the opportunity to attend exercise social support groups in their communities .
METHODS	Interventions lasted 6 months .
METHODS	The primary outcome was frequency of hot flushes/night sweats at 6-month up .
RESULTS	Two hundred and sixty-one women were randomised ( n = 87 per group ) .
RESULTS	Neither of the exercise intervention groups reported significantly less frequent hot flushes/night sweats per week than controls ( exercise-DVD versus control : -8.9 , 95 % CI -20.0 to 2.2 ; exercise-social support versus control : -5.2 , 95 % CI -16.7 to 6.3 ) .
CONCLUSIONS	This trial indicates that exercise is not an effective treatment for hot flushes/night sweats .
CONCLUSIONS	Contrary to current clinical guidance , women should not be advised that exercise will relieve their vasomotor menopausal symptoms .

###24453807
OBJECTIVE	To fully analyze and compare BMI among Han , Tibetan , and Uygur university students , to discuss the differences in their physical properties and physical health , and thus to provide some theoretical suggestions for the improvement of students ' physical health .
METHODS	The cross-sectional random cluster sampling was used to investigate 10103 Han , Tibetan , and Uygur university students , aged 20-24 in Northwest China , and their height and weight were measured to calculate BMI .
METHODS	The BMI classification criteria for Chinese established by Work Group on Obesity in China ( WGOC ) were used for screening .
RESULTS	Han , Tibetan , and Uygur university students show low obesity rates but high overweight rates .
RESULTS	Han , Tibetan , and Uygur university students present a high rate of underweight , normal weight , and overweight , respectively .
RESULTS	Female Han students show higher underweight and normal weight rates , but lower overweight and obesity rates , than male Han students .
RESULTS	Female Tibetan students show higher normal weight rate , but lower overweight and obesity rates , than male Tibetan students .
RESULTS	BMI increases with age for male students but decreases with age for female students .
RESULTS	Male Uygur students show higher obesity rate than female Uygur students .
RESULTS	Tibetan and Uygur university students have higher BMI than other minorities in South China .

###24650819
OBJECTIVE	Although couples ' alcohol use has been associated with intimate partner aggression and poorer marital functioning , few studies have examined the proximal effects of alcohol on couple interactions .
OBJECTIVE	The current experimental study examined the effects of alcohol , administered independently to male and female intimate partners , on positive and negative interaction behaviors within a naturalistic conflict resolution paradigm .
METHODS	Married and cohabiting couples ( n = 152 ) were recruited from the community and each partner randomly assigned to receive either alcohol ( target dose : .08 mg/kg ) or no alcohol .
METHODS	They engaged in two 15-minute interactions regarding current disagreements in their relationship , one before and one after beverage administration .
METHODS	Videotaped interactions were coded by trained observers using the Rapid Marital Interaction Coding System , and positive and negative interaction behaviors were analyzed using the Actor-Partner Interdependence Model .
RESULTS	Participants displayed decreased negativity and increased positivity following alcohol consumption when their partners were sober but no differences in negativity or positivity when their partners also consumed alcohol .
RESULTS	There were no gender differences .
RESULTS	Although participants with a history of perpetrating intimate partner aggression displayed more negativity , prior aggression did not interact with beverage condition .
CONCLUSIONS	The immediate effects of alcohol consumption on couple interaction behaviors appeared more positive than negative .
CONCLUSIONS	Contrary to hypotheses , congruent partner drinking had neither particularly positive nor particularly negative effects .
CONCLUSIONS	These unique findings represent a rare glimpse into the immediate consequences of alcohol consumption on couple interaction and stand in contrast to its delayed or long-term effects .

###24435411
BACKGROUND	Colorectal cancer ( CRC ) screening is cost-effective but underused .
BACKGROUND	The objective of this study was to determine the cost-effectiveness of a mailed standard intervention ( SI ) and tailored navigation interventions ( TNIs ) to increase CRC screening use in the context of a randomized trial among primary care patients .
METHODS	Participants ( n = 945 ) were randomized either to a usual care control group ( n = 317 ) , to an SI group ( n = 316 ) , or to a TNI group ( n = 312 ) .
METHODS	The SI group was sent both colonoscopy instructions and stool blood tests irrespective of baseline preference .
METHODS	TNI group participants were sent instructions for scheduling a colonoscopy , a stool blood test , or both based on their test preference , as determined at baseline ; then , they received a navigation telephone call .
METHODS	Activity cost estimation was used to determine the cost of each intervention and to compute incremental cost-effectiveness ratios .
METHODS	Statistical uncertainty within the base case was assessed with 95 % confidence intervals derived from net benefit regression analysis .
METHODS	The effects of uncertain parameters , such as the cost of planning , training , and involvement of those receiving `` investigator salaries , '' were assessed with sensitivity analyses .
RESULTS	Program costs of the SI were $ 167 per participant .
RESULTS	The average cost of the TNI was $ 289 per participant .
CONCLUSIONS	The TNI was more effective than the SI but substantially increased the cost per additional individual screened .
CONCLUSIONS	Decision-makers need to consider cost structure , level of planning , and training required to implement these 2 intervention strategies and their willingness to pay for additional individuals screened to determine whether a tailored navigation would be justified and feasible .

###24314872
BACKGROUND	Posterior wall fractures are one of the most common acetabular fractures .
BACKGROUND	However , only 30 % of these fractures involve a single large fragment , and comminuted acetabular posterior wall fractures pose a particular surgical challenge .
BACKGROUND	The purpose of this study was to compare outcomes between patients who received fixation for comminuted posterior wall fracture using the Acetabular Tridimensional Memory Fixation System ( ATMFS ) and patients who underwent fixation with conventional screws and buttress plates ( Plates group ) .
METHODS	Between April 2003 and May 2007 , 196 consecutive patients who sustained a comminuted posterior wall fracture of acetabulum were treated with ATMFS or conventional screws and buttress plates .
METHODS	Operative time , fluoroscopy time , blood loss , and any intra-operative complications were recorded .
METHODS	Plain AP and lateral radiographs were obtained at all visits ( Matta 's criteria ) .
METHODS	Modified Merle d' Aubigne-Postel score , and Mos SF-36 score were compared between groups .
RESULTS	Fifty patients were included in the analysis with 26 in the ATMFS group and 24 in the Plates group .
RESULTS	The mean follow-up time was 57.5 months , ranging from 31 to 69 months .
RESULTS	All patients had fully healed fractures at the final follow-up .
RESULTS	There was no difference in clinical outcomes or radiological evaluations between groups .
CONCLUSIONS	Patients with comminuted posterior wall fractures of the acetabulum treated with the ATMFS or conventional screws and buttress plate techniques achieve a good surgical result .
CONCLUSIONS	Both techniques are safe , reliable , and practical .
CONCLUSIONS	Use of the ATMFS technique may reduce blood loss and improve rigid support to marginal bone impaction .
CONCLUSIONS	The use ATMFS may need additional support when fractures involve the superior roof .

###25424991
OBJECTIVE	Both valganciclovir and high-dose valacyclovir are recommended for cytomegalovirus prophylaxis after renal transplantation .
OBJECTIVE	A head-to-head comparison of both regimens is lacking .
OBJECTIVE	The objective of the study was to compare valacyclovir prophylaxis with valganciclovir , which constituted the control group .
METHODS	In a randomized , open-label , single-center trial , recipients of renal transplants ( recipient or donor cytomegalovirus-seropositive ) were randomly allocated ( 1:1 ) to 3-month prophylaxis with valacyclovir ( 2 g four times daily ) or valganciclovir ( 900 mg daily ) .
METHODS	Enrollment occurred from November of 2007 to April of 2012 .
METHODS	The primary end points were cytomegalovirus DNAemia and biopsy-proven acute rejection at 12 months .
METHODS	Analysis was by intention to treat .
RESULTS	In total , 119 patients were assigned to valacyclovir ( n = 59 ) or valganciclovir prophylaxis ( n = 60 ) .
RESULTS	Cytomegalovirus DNAemia developed in 24 ( 43 % ) of 59 patients in the valacyclovir group and 18 ( 31 % ) of 60 patients in the valganciclovir group ( adjusted hazard ratio , 1.35 ; 95 % confidence interval , 0.71 to 2.54 ; P = 0.36 ) .
RESULTS	The incidence of cytomegalovirus disease was 2 % with valacyclovir and 5 % with valganciclovir prophylaxis ( adjusted hazard ratio , 0.21 ; 95 % confidence interval , 0.01 to 5.90 ; P = 0.36 ) .
RESULTS	Significantly more patients with valacyclovir prophylaxis developed biopsy-proven acute rejection ( 18 of 59 [ 31 % ] versus 10 of 60 [ 17 % ] ; adjusted hazard ratio , 2.49 ; 95 % confidence interval , 1.09 to 5.65 ; P = 0.03 ) .
RESULTS	The incidence of polyomavirus viremia was higher in the valganciclovir group ( 18 % versus 36 % ; adjusted hazard ratio , 0.43 ; 95 % confidence interval , 0.19 to 0.96 ; P = 0.04 ) .
CONCLUSIONS	Valganciclovir shows no superior efficacy in cytomegalovirus DNAemia prevention compared with valacyclovir prophylaxis .
CONCLUSIONS	However , the risk of biopsy-proven acute rejection is higher with valacyclovir .

###24992752
OBJECTIVE	To assess the effects of using Chinese herbs in assisted reproductive technology .
METHODS	Four hundred and thirty-three subjects aged less than 42 years with infertility due to Fallopian tube or male-related factors who were willing to undertake in vitro fertilization and embryo transplantation were randomly allocated to a Chinese herb intervention group ( n = 216 ) or a conventional treatment control group ( n = 217 ) .
METHODS	All subjects received one of four routine ultra-ovulation-promoting therapies at the Reproductive Center in the Third Hospital Affiliated to Beijing University according to their physician 's assessments .
METHODS	The subjects in the intervention group received various Chinese herbs depending on their conventional treatment .
METHODS	Endometrial thickness , number of acquired eggs , and rates of normal fertility , high-quality embryos , biochemical and clnical pregnancy of subjects were assessed in both groups .
RESULTS	The high-quality embryo rate of 51.9 % , biochemical pregnancy rate of 51.0 % , clinical pregnancy rate of 44.2 % and endometrial thickness of ( 10.84 + / - 1.75 ) mm in the intervention group were all significantly higher than those in the control group [ 48.7 % , 38.9 % , 34.8 % , and ( 10.52 + / - 1.50 ) mm , respectively ; P < 0.05 ] .
RESULTS	The normal fertility rate of 58.5 % in the Chinese herb group was also significantly superior to the 54.7 % achieved in the control group ( P < 0.01 ) .
RESULTS	There were no statistically significant differences ( P > 0.05 ) in the average number of acquired eggs within a single cycle , incidence of excessive stimulation of ovary , rates of embryo transplantation or early abortion and birth of living babies between the two groups .
CONCLUSIONS	Our findings indicate that Chinese herbs increase endometrial thickness , improve the quality of fertility and embryo , and promote embryonic nidation , thus enhancing the success rate of in vitro fertilization/intracytoplasmic sperm injection-embryo transplantation cycle .
CONCLUSIONS	Using Chinese herbs improves the outcomes and safety of assisted reproductive technologies .

###25631485
OBJECTIVE	To compare the efficacy and safety of 3 % diquafosol ophthalmic solution with those of 0.1 % sodium hyaluronate ophthalmic solution in patients with dry eye in China and Singapore .
METHODS	A total of 497 patients with dry eye ( Schirmer 's test , 5mm ; fluorescein and RB score , 3 points ) from China and Singapore were randomised to receive either diquafosol ophthalmic solution ( diquafosol ) or sodium hyaluronate ophthalmic solution ( HA ) at 1:1 ratio .
METHODS	The fluorescein staining scores and rose bengal ( RB ) subjective symptom scores and tear film breakup time were evaluated before treatment and 2 and 4weeks after start of treatment .
RESULTS	In the diquafosol group , changes in fluorescein and RB scores compared with baseline at week 4 or at the time of discontinuation were -2.11.5 and -2.52.0 , respectively .
RESULTS	Compared with the HA group , changes in fluorescein score were non-inferior and changes in RB score were superior ( p = 0.019 ) .
RESULTS	In addition , diquafosol and HA improved tear film breakup time by 1.0461.797 and 0.8321.775 s , respectively ( no significant intergroup difference ) .
RESULTS	Adverse event onset rates were 16.3 % ( 40 of 246 subjects ) and 10.0 % ( 25 of 251 subjects ) in the diquafosol group and HA group , respectively , with borderline significant intergroup differences ( p = 0.046 ) , while adverse drug reaction incidence rates were 12.2 % ( 30 of 246 subjects ) and 6.0 % ( 15 of 251 subjects ) , respectively ( p = 0.019 ) .
RESULTS	Only mild adverse drug reactions ( > 2 % ) in the form of eye discharge , itching or irritation were observed .
CONCLUSIONS	Diquafosol improved fluorescein staining score in a manner similar to HA , and significantly improved RB score compared with HA .
BACKGROUND	NCT01101984 .

###25054387
BACKGROUND	Epidural injections are the most common minimally invasive intervention used to manage low back pain with lumbosacral radicular pain .
BACKGROUND	It can be delivered through either transforaminal ( TF ) , interlaminar , or caudal approaches .
BACKGROUND	The TF approach is considered more efficacious than the interlaminar approach probably because of ventral epidural spread .
BACKGROUND	However , catastrophic complications reported with the TF approach have raised concerns regarding its use .
BACKGROUND	These concerns regarding the safety of the TF approach lead to the search for a technically better route with lesser complications with drug delivery into the ventral epidural space .
BACKGROUND	The parasagittal interlaminar ( PIL ) route is reported to have good ventral epidural spread .
BACKGROUND	However , there is a paucity of literature comparing the effectiveness of PIL with TF .
OBJECTIVE	To compare effectiveness of PIL and TF epidural injections for managing low back pain with lumbosacral radicular pain .
METHODS	Randomized , double-blind , active-control study .
METHODS	Interventional pain management clinic in a tertiary care center in India .
METHODS	Sixty-two patients were randomized to receive fluoroscopically guided epidural injection of methylprednisolone ( 80 mg ) either through the PIL ( n = 32 ) or TF ( n = 30 ) approach .
METHODS	Patients were evaluated for effective pain relief ( 50 % from baseline ) by 0 - 100 visual analogue scale ( VAS ) and functional improvement by Modified Oswestry Disability Questionnaire ( MODQ ) at 2 weeks , 1 , 2 , 3 , 6 , 9 , and 12 months .
METHODS	Patients who failed to respond to the treatment or when the patient 's response deteriorated received additional injection of same injectate , dose , and approach .
METHODS	Only if the pain returns should there be a maximum of 3 injections .
METHODS	Other outcome measures were overall VAS and MODQ , number of injections , and presence of ventral and perineural spread .
RESULTS	Effective pain relief ( 50 % pain relief from baseline on VAS ) was observed in 76 % ( 90 % CI 60.6 - 88.5 % ) of patients in the TF group and 78 % ( 90 % CI 62.8 - 89.3 % ) of patients in the PIL ( P = 1.00 ) group at 3 months .
RESULTS	The pain relief survival period was comparable in both groups ( P = 0.98 ) .
RESULTS	Significant reduction in VAS and improvement in MODQ were observed at all time points post-intervention compared to baseline ( P < 0.001 ) in both groups .
RESULTS	On average , patients in the PIL group received 1.84 and patients in the TF group received 1.92 procedures annually .
RESULTS	The majority received injection at L4-L5 intervertebral level ( 24 in TF and 23 in PIL ) .
RESULTS	Ventral epidural spread was comparable in both groups ( PIL - 91.6 % and TF - 89.6 % ) .
RESULTS	No major complications were encountered in either group ; however , initial intravascular spread of contrast was observed in 3 patients in the TF group .
CONCLUSIONS	Limitations included lack of documentation of adjuvant analgesic drug therapy and procedures performed by a single experienced interventionalist .
CONCLUSIONS	Epidural injection delivered through the PIL approach is equivalent in achieving effective pain relief and functional improvement to the TF approach for the management of low back pain with lumbosacral radicular pain .
CONCLUSIONS	The PIL approach can be considered a suitable alternative to the TF approach for its equivalent effectiveness , probable better safety profile , and technical ease .
BACKGROUND	CTRI/2012/08 / 002938 .

###25194928
BACKGROUND	In recent years , virtual reality has been introduced to neurorehabilitation , in particular with the intention of improving upper-limb training options and facilitating motor function recovery .
METHODS	The proposed study incorporates a quantitative part and a qualitative part , termed a mixed-methods approach : ( 1 ) a quantitative investigation of the efficacy of virtual reality training compared to conventional therapy in upper-limb motor function are investigated , ( 2a ) a qualitative investigation of patients ' experiences and expectations of virtual reality training and ( 2b ) a qualitative investigation of therapists ' experiences using the virtual reality training system in the therapy setting .
METHODS	At three participating clinics , 60 patients at least 6 months after stroke onset will be randomly allocated to an experimental virtual reality group ( EG ) or to a control group that will receive conventional physiotherapy or occupational therapy ( 16 sessions , 45 minutes each , over the course of 4 weeks ) .
METHODS	Using custom data gloves , patients ' finger and arm movements will be displayed in real time on a monitor , and they will move and manipulate objects in various virtual environments .
METHODS	A blinded assessor will test patients ' motor and cognitive performance twice before , once during , and twice after the 4-week intervention .
METHODS	The primary outcome measure is the Box and Block Test .
METHODS	Secondary outcome measures are the Chedoke-McMaster Stroke Assessments ( hand , arm and shoulder pain subscales ) , the Chedoke-McMaster Arm and Hand Activity Inventory , the Line Bisection Test , the Stroke Impact Scale , the MiniMentalState Examination and the Extended Barthel Index .
METHODS	Semistructured face-to-face interviews will be conducted with patients in the EG after intervention finalization with a focus on the patients ' expectations and experiences regarding the virtual reality training .
METHODS	Therapists ' perspectives on virtual reality training will be reviewed in three focus groups comprising four to six occupational therapists and physiotherapists .
CONCLUSIONS	The interviews will help to gain a deeper understanding of the phenomena under investigation to provide sound recommendations for the implementation of the virtual reality training system for routine use in neurorehabilitation complementing the quantitative clinical assessments .
BACKGROUND	Cliniclatrials.gov Identifier : NCT01774669 ( 15 January 2013 ) .

###24622029
OBJECTIVE	Cochlear implants ( CIs ) are typically activated 3 to 6 weeks after the surgery .
OBJECTIVE	For some patients who live in remote areas , this waiting period could impose some personal and financial burdens .
OBJECTIVE	The current study examined whether CI recipients can be safely and effectively fitted with their speech processor five days after their implantation .
METHODS	Randomized controlled trial .
METHODS	Tertiary referral center .
METHODS	A total of 23 patients ( 2-30 yr of age ) undergoing traditional CI surgery were recruited to participate in this study .
METHODS	Participants were divided into 2 groups : an early-fit group whose devices were activated 5 days after surgery and standard-fit group whose devices were activated using the recommended waiting period .
METHODS	Measures of impedance and most comfortable levels were used to compare differences across the 2 groups of patients .
METHODS	Data were measured at the activation session and also at 4 weeks after the initial session .
RESULTS	No adverse events were reported postoperatively .
RESULTS	Electrode impedances were significantly lower for the early-fit group than that for the standard-fit group in the initial activation session but not in the 4-week follow-up session .
RESULTS	There were no significant differences between the 2 groups in the stimulation fitting levels in any of the sessions .
CONCLUSIONS	The results presented in this article demonstrated that early activation for this sample did not seem to interfere with wound healing or with the fitting parameters suggesting that early activation should be considered as viable option to better serve CI patients ' individual needs .

###24771609
OBJECTIVE	The implications of geographical variation are unknown following adjustment for hospital length of stay ( LOS ) in heart failure ( HF ) trials that included patients whether or not they had systolic dysfunction .
OBJECTIVE	We investigated regional differences in an international acute HF trial .
RESULTS	The PROTECT trial investigated 2033 patients with acute HF and renal dysfunction hospitalized at 173 sites in 17 countries with randomization to rolofylline or placebo .
RESULTS	We grouped enrolling countries into six regions .
RESULTS	Baseline characteristics , in-hospital management , and outcomes were explored by region .
RESULTS	The primary study outcome was 60-day mortality or cardiovascular/renal hospitalization .
RESULTS	Secondary outcomes included 180-day mortality .
RESULTS	Of 2033 patients , 33 % were from Eastern Europe , 19 % from Western Europe , 16 % from Israel , 15 % from North America , 14 % from Russia , and 3 % from Argentina .
RESULTS	Marked differences in baseline characteristics , HF phenotype , in-hospital diuretic and vasodilator strategies , and LOS were observed by region .
RESULTS	LOS was shortest in North America and Israel ( median 5 days ) and longest in Russia ( median 15 days ) .
RESULTS	Regional event rates varied significantly .
RESULTS	Following multivariable adjustment , region was an independent predictor of the risk of mortality/hospitalization at 60 days , with the lowest risk in Russia ( hazard ratio 0.39 , 95 % confidence interval 0.23-0 .64 vs. Western Europe ) due to lower rehospitalization ; mortality differences were attenuated by 180 days .
CONCLUSIONS	In an international HF trial , there were differences in baseline characteristics , treatments , LOS , and rehospitalization amongst regions , but little difference in longer term mortality .
CONCLUSIONS	Rehospitalization differences exist independent of LOS .
CONCLUSIONS	This analysis may help inform future trial design and should be externally validated .

###25840693
BACKGROUND	Ipilimumab is an approved treatment for patients with advanced melanoma .
BACKGROUND	We aimed to assess ipilimumab as adjuvant therapy for patients with completely resected stage III melanoma at high risk of recurrence .
METHODS	We did a double-blind , phase 3 trial in patients with stage III cutaneous melanoma ( excluding lymph node metastasis 1 mm or in-transit metastasis ) with adequate resection of lymph nodes ( ie , the primary cutaneous melanoma must have been completely excised with adequate surgical margins ) who had not received previous systemic therapy for melanoma from 91 hospitals located in 19 countries .
METHODS	Patients were randomly assigned ( 1:1 ) , centrally by an interactive voice response system , to receive intravenous infusions of 10 mg/kg ipilimumab or placebo every 3 weeks for four doses , then every 3 months for up to 3 years .
METHODS	Using a minimisation technique , randomisation was stratified by disease stage and geographical region .
METHODS	The primary endpoint was recurrence-free survival , assessed by an independent review committee , and analysed by intention to treat .
METHODS	Enrollment is complete but the study is ongoing for follow-up for analysis of secondary endpoints .
METHODS	This trial is registered with EudraCT , number 2007-001974-10 , and ClinicalTrials.gov , number NCT00636168 .
RESULTS	Between July 10 , 2008 , and Aug 1 , 2011 , 951 patients were randomly assigned to ipilimumab ( n = 475 ) or placebo ( n = 476 ) , all of whom were included in the intention-to-treat analyses .
RESULTS	At a median follow-up of 274 years ( IQR 228-322 ) , there were 528 recurrence-free survival events ( 234 in the ipilimumab group vs 294 in the placebo group ) .
RESULTS	Median recurrence-free survival was 261 months ( 95 % CI 193-393 ) in the ipilimumab group versus 171 months ( 95 % CI 134-216 ) in the placebo group ( hazard ratio 075 ; 95 % CI 064-090 ; p = 00013 ) ; 3-year recurrence-free survival was 465 % ( 95 % CI 415-513 ) in the ipilimumab group versus 348 % ( 301-395 ) in the placebo group .
RESULTS	The most common grade 3-4 immune-related adverse events in the ipilimumab group were gastrointestinal ( 75 [ 16 % ] vs four [ < 1 % ] in the placebo group ) , hepatic ( 50 [ 11 % ] vs one [ < 1 % ] ) , and endocrine ( 40 [ 8 % ] vs none ) .
RESULTS	Adverse events led to discontinuation of treatment in 245 ( 52 % ) of 471 patients who started ipilimumab ( 182 [ 39 % ] during the initial treatment period of four doses ) .
RESULTS	Five patients ( 1 % ) died due to drug-related adverse events .
RESULTS	Five ( 1 % ) participants died because of drug-related adverse events in the ipilimumab group ; three patients died because of colitis ( two with gastrointestinal perforation ) , one patient because of myocarditis , and one patient because of multiorgan failure with Guillain-Barr syndrome .
CONCLUSIONS	Adjuvant ipilimumab significantly improved recurrence-free survival for patients with completely resected high-risk stage III melanoma .
CONCLUSIONS	The adverse event profile was consistent with that observed in advanced melanoma , but at higher incidences in particular for endocrinopathies .
CONCLUSIONS	The risk-benefit ratio of adjuvant ipilimumab at this dose and schedule requires additional assessment based on distant metastasis-free survival and overall survival endpoints to define its definitive value .
BACKGROUND	Bristol-Myers Squibb .

###24562510
OBJECTIVE	To compare sedation outcomes for chloral hydrate ( CH ) and midazolam ( MD ) as sedative agents for diagnostic procedures in children .
METHODS	A prospective , randomized , double-blinded study conducted between July 2005 and October 2006 , at the Pediatric Day Care Unit ( DCU ) , King Abdulaziz Medical City , Riyadh , Saudi Arabia .
METHODS	After meeting the inclusion criteria and getting informed consent , patients were randomized , given the study drug , and monitored for sedation outcomes .
RESULTS	Two hundred and seventy-five patients who had 292 sedation sessions for diagnostic procedures were included in the study .
RESULTS	Due to missing data , 286 sedations were included in the final analysis ; 144 in the CH and 142 in the MD group .
RESULTS	Both groups were comparable with respect to demographic and baseline characteristics .
RESULTS	The CH compared to MD group , had a higher sedation success rate , shorter time to achieve sedation , shorter length of stay in DCU , and longer sedation duration .
RESULTS	In both study groups , patients who required a second dose tended to be older and heavier .
RESULTS	No major side effects were encountered .
RESULTS	The CH group had a significantly higher mean sedation scores at 15 , 30 , 45 , and 60 minutes .
CONCLUSIONS	Chloral hydrate compared to MD , had a shorter time to achieve sedation , a higher success rate , less need for a second dose , and decreased the time spent in the DCU .
CONCLUSIONS	Older and heavier patients are more likely to require a second dose of the study drug to be sedated .

###25422235
OBJECTIVE	Hapatitis B visus ( CHB ) - induced fibrosis is a precancerous condition of liver .
OBJECTIVE	To explore the influence of Chongcao Preparation ( Chongcao Yigan Capsule ) on the function of intestinal flora and chemoprevention for patients with CHB-induced liver fibrosis .
METHODS	A total of 136 patients with CHB-induced liver fibrosis were randomly divided into control group treated with lamivudine ( LAM ) and research group added with Chongcao Yigan Capsule for totally 48 weeks .
METHODS	The changes of intestinal flora , secretory immunoglobin A ( SIgA ) , serum albumin ( ALB ) , prealbumin ( PALB ) , IgA and IgG at different time points in both groups were observed .
RESULTS	Before treatment , there was no significant difference between two groups in each index ( P > 0.05 ) .
RESULTS	After treatment , the intestinal flora were evidently optimized in research group than treatment before ( P < 0.05 or P < 0.01 ) , and were apparently better than those in control group ( P < 0.05 or P < 0.01 ) ; SIgA was obviously increased and ALB , PALB , IgA and IgG were markedly improved in research group than treatment before ( P < 0.05 or P < 0.01 ) , and were significantly better than those in control group ( P < 0.05 or P < 0.01 ) .
CONCLUSIONS	Chongcao Yigan Capsule could regulate the intestinal flora , increase SIgA , serum ALB and PALB concentrations and significantly improve serum IgA and IgG as well as strengthen the immunological function and autologous repair capacity of patients with CHB-induced liver fibrosis .

###24663481
OBJECTIVE	Our objective was to evaluate the prevention of incisional hernia ( IH ) during the postoperative period of a midline laparotomy during elective surgery .
METHODS	A controlled , prospective , randomized , and blind study was carried out .
METHODS	The patients in group A ( mesh ) were fitted with a polypropylene mesh , to reinforce the standard abdominal wall closure .
METHODS	The patients in group B ( non-mesh ) underwent a standard abdominal wall closure and were not fitted with the mesh .
RESULTS	In group A , 2/80 his were diagnosed , whereas in group B the number was 30/80 .
RESULTS	The Kaplan-Meier survival curves show that the likelihood of IH at 12 months is 1.5 % in group A compared with 35.9 % in group B ( p < 0.0001 ) , which means that the differences are statistically significant .
CONCLUSIONS	Fitting a prophylactic supra-aponeurotic mesh prevents IH independently of other factors .

###25043629
OBJECTIVE	Ankle sprain is a frequently encountered traumatic injury in emergency departments and is associated with important health expenses .
OBJECTIVE	However , the appropriate care of this traumatic injury remains a matter of debate .
OBJECTIVE	We tested the hypothesis that compression stockings speed up recovery from ankle sprain .
METHODS	Recent ( < 48 hours ) cases of ankle sprain without other traumatic injury in patients aged between 18 and 55 years were included .
METHODS	Patients were randomly allocated to placebo Jersey or class II compression stockings ( Venoflex ; Thuasne , Levallois-Perret , France ) .
METHODS	The primary end point was the time to recovery of normal painless walking without requirement for analgesic drug .
METHODS	Secondary end points were time to return to sport activity , pain , analgesic consumption , and ankle edema ( bimalleolar and midfoot circumferences ) .
RESULTS	We randomized 126 patients and analyzed 117 patients ( 60 in the placebo group and 57 in the compression group ) .
RESULTS	The median time to normal painless walking was not significantly decreased ( P = .16 ) .
RESULTS	No significant differences were observed in pain , analgesic consumption , and bimalleloar and midfoot circumferences .
RESULTS	No safety issue was reported .
RESULTS	In the subgroup of patients with regular sport activity , the time to return to sport activity was shorter in patients treated with compression stockings ( P = .02 ) .
CONCLUSIONS	Compression stockings failed to significantly modify the time to return to normal painless walking in ankle sprain .
CONCLUSIONS	A beneficial effect was observed only in a subgroup of patients , as compression stockings significantly decreased the time to return to sport activity .

###25711327
OBJECTIVE	With HIV treatment prolonging survival and HIV infection now managed as a chronic illness , quality of life ( QOL ) is important to evaluate in persons living with HIV ( PLWH ) .
OBJECTIVE	We assessed at study entry the QOL of antiretroviral-nave PLWH with CD4 counts > 500 cells/L in the Strategic Timing of AntiRetroviral Treatment ( START ) clinical trial .
METHODS	QOL was assessed with : ( 1 ) a visual analogue scale ( VAS ) for self-assessment of overall current health ; ( 2 ) the Short-Form 12-Item Version 2 Health Survey ( ) ( SF-12V2 ) , for which responses are summarized into eight individual QOL domains plus component summary scores for physical health [ the Physical Health Component Summary ( PCS ) ] and mental health [ the Mental Health Component Summary ( MCS ) ] .
METHODS	The VAS and eight domain scores were scaled from 0 to 100 .
METHODS	Mean QOL measures were calculated overall and by demographic , clinical and behavioural factors .
RESULTS	A total of 4631 participants completed the VAS and 4119 the SF-12 .
RESULTS	The mean VAS score ( with standard deviation ) was 80.915.7 .
RESULTS	Mean SF-12 domain scores were lowest for vitality ( 66.326.4 ) and mental health ( 68.621.4 ) , and highest for physical functioning ( 89.323.0 ) and bodily pain ( 88.021.4 ) .
RESULTS	Using multiple linear regression , PCS scores were lower ( P < 0.001 ) for Asians , North Americans , female participants , older participants , and those with less education , longer duration of known HIV infection , alcoholism/substance dependence and body mass index 30kg/m ( 2 ) .
RESULTS	MCS scores were highest ( P < 0.001 ) for Africans , South Americans and older participants , and lowest for female participants , current smokers and those with alcoholism/substance dependence .
CONCLUSIONS	In this primarily healthy population , QOL was mostly favourable , emphasizing that it is important that HIV treatments do not negatively impact QOL .
CONCLUSIONS	Self-assessed physical health summary scores were higher than mental health scores .
CONCLUSIONS	Factors such as older age and geographical region had different effects on perceived physical and mental health .

###25467566
BACKGROUND	Mechanical chest compression devices have the potential to help maintain high-quality cardiopulmonary resuscitation ( CPR ) , but despite their increasing use , little evidence exists for their effectiveness .
BACKGROUND	We aimed to study whether the introduction of LUCAS-2 mechanical CPR into front-line emergency response vehicles would improve survival from out-of-hospital cardiac arrest .
METHODS	The pre-hospital randomised assessment of a mechanical compression device in cardiac arrest ( PARAMEDIC ) trial was a pragmatic , cluster-randomised open-label trial including adults with non-traumatic , out-of-hospital cardiac arrest from four UK Ambulance Services ( West Midlands , North East England , Wales , South Central ) .
METHODS	91 urban and semi-urban ambulance stations were selected for participation .
METHODS	Clusters were ambulance service vehicles , which were randomly assigned ( 1:2 ) to LUCAS-2 or manual CPR .
METHODS	Patients received LUCAS-2 mechanical chest compression or manual chest compressions according to the first trial vehicle to arrive on scene .
METHODS	The primary outcome was survival at 30 days following cardiac arrest and was analysed by intention to treat .
METHODS	Ambulance dispatch staff and those collecting the primary outcome were masked to treatment allocation .
METHODS	Masking of the ambulance staff who delivered the interventions and reported initial response to treatment was not possible .
METHODS	The study is registered with Current Controlled Trials , number ISRCTN08233942 .
RESULTS	We enrolled 4471 eligible patients ( 1652 assigned to the LUCAS-2 group , 2819 assigned to the control group ) between April 15 , 2010 and June 10 , 2013.985 ( 60 % ) patients in the LUCAS-2 group received mechanical chest compression , and 11 ( < 1 % ) patients in the control group received LUCAS-2 .
RESULTS	In the intention-to-treat analysis , 30 day survival was similar in the LUCAS-2 group ( 104 [ 6 % ] of 1652 patients ) and in the manual CPR group ( 193 [ 7 % ] of 2819 patients ; adjusted odds ratio [ OR ] 086 , 95 % CI 064-115 ) .
RESULTS	No serious adverse events were noted .
RESULTS	Seven clinical adverse events were reported in the LUCAS-2 group ( three patients with chest bruising , two with chest lacerations , and two with blood in mouth ) .
RESULTS	15 device incidents occurred during operational use .
RESULTS	No adverse or serious adverse events were reported in the manual group .
CONCLUSIONS	We noted no evidence of improvement in 30 day survival with LUCAS-2 compared with manual compressions .
CONCLUSIONS	On the basis of ours and other recent randomised trials , widespread adoption of mechanical CPR devices for routine use does not improve survival .
BACKGROUND	National Institute for Health Research HTA - 07/37/69 .

###25829156
BACKGROUND	The authors compared the reduction of migraine headache frequency , days , severity , and duration after surgical decompression versus avulsion of the zygomaticotemporal branch of the trigeminal nerve for treatment of temporal migraine headache .
METHODS	Twenty patients with bilateral temporal migraine headache were randomized to undergo avulsion of the zygomaticotemporal branch of the trigeminal nerve on one side and decompression via fasciotomy and removal of the zygomaticotemporal artery on the other side .
METHODS	Results were analyzed after a minimum of 12 months of follow-up .
RESULTS	Nineteen patients completed the study .
RESULTS	The patients experienced greater than 50 percent improvement in frequency , migraine days , severity , and duration in 34 of the 38 operative sites ( 89 percent ) .
RESULTS	Complete elimination of symptoms was noted in 21 of the 38 operative sites ( 55 percent ) .
RESULTS	In the decompression group , migraine frequency was reduced from 14.6 to 2.2 per month , migraine days from 14.1 to 2.3 , severity from 7.0 to 2.9 , duration from 9.6 to 4.8 hours , and Migraine Headache Index score from 42 to 2.9 .
RESULTS	In the neurectomy group , frequency decreased from 14.2 to 1.9 per month , migraine days from 14.1 to 2.3 , severity from 6.8 to 2.6 , migraine duration from 10.1 to 5.3 hours , and the Migraine Headache Index score from 41 to 2.5 .
RESULTS	There was no statistical significance in reduced migraine headache frequency , days , severity , and duration between the two groups .
CONCLUSIONS	Neurectomy and decompression of the zygomaticotemporal branch of the trigeminal nerve are both appropriate treatment for temporal migraine headache .
CONCLUSIONS	If decompression fails to provide sufficient relief , neurectomy is another option .
METHODS	Therapeutic , I.

###25697814
BACKGROUND	The success of ACL reconstruction is predicated on a variety of factors .
BACKGROUND	Tunnel placement plays one of the most significant roles in achieving knee kinematics and function .
BACKGROUND	The purposes of this study were to compare femoral tunnel position , angle , length and posterior wall blow-out after ACL reconstruction with hamstring tendons autograft through either a farmedial portal or an anteromedial portal technique .
METHODS	We evaluated 36 patients who underwent ACL reconstruction between January 2014 and July 2014 in our institute , in a prospective , randomised cohort study .
METHODS	All the surgical procedures were performed by a sports fellowship-trained orthopaedic surgeon with experience in both portal reaming .
METHODS	The operated knees were evaluated with 0.5 mm fine CT scans of 3-D CT between days 3 and 5 postoperatively .
RESULTS	According to the 3-D CT measurements , the mean femoral tunnel length was significantly longer ( p < 0.05 ) in the FAM group compared with the AM group .
RESULTS	The femoral bone tunnel length averaged 34.2 3.6 mm versus 36.6 3.0 mm ( p = 0.042 ) in AM and the FAM groups , respectively .
RESULTS	The femoral tunnel position , as evaluated with use of the quadrant method , was more anterior in the FAM transportal technique group , and the difference between the two groups was significant ( p < 0.05 ) .
CONCLUSIONS	FAM tranportal drilling of the femoral tunnel creates longer and anterior femoral tunnels with regard to the AM portal drilling techniques .
CONCLUSIONS	Additional studies with clinical outcomes are required for the clinical relevance of these techniques and to show which one is superior .
METHODS	Level I , prospective randomised comparative cohort study .

###25767938
BACKGROUND	Three-dimensional ( 3D ) laparoscopes have been developed to maintain the perception of depth in the operating field .
BACKGROUND	Two-dimensional ( 2D ) imaging relies on tactile feedback , visual cues , and previous experience .
BACKGROUND	The aim of this study was to test if 3D laparoscopic vision is superior to 2D laparoscopic vision in training novice operators in completing set laparoscopic tasks .
METHODS	The study population consisted of 20 interns and medical students .
METHODS	The participants were randomized to completing tasks using a 2D or 3D system .
METHODS	These included pegboard transfer ( PT ) , continuous suturing ( CS ) , and intracorporeal knot-tying ( IK ) .
METHODS	The time to complete the task and number of errors made were recorded .
RESULTS	Following adjustment for potential confounders , time to complete CS and IK was significantly longer among participants who used the 2D laparoscope compared with those who used the 3D laparoscope ( CS , P < .0001 ; IK , P < .0001 ) .
RESULTS	This same effect was not demonstrated in time to perform PT ( PT , P = .04 ) .
RESULTS	The 2D laparoscope was associated with a significant increase in the number of errors on the IK task ( P < .0001 ) but not on the PT or CS tasks ( PT , P = .35 ; CS , P = .26 ) .
CONCLUSIONS	The 3D system assists novice operators perform more complex laparoscopic tasks in a decreased amount of time and with fewer errors .

###25227570
BACKGROUND	Office computer workers are at increased risk for neck/upper extremity ( UE ) musculoskeletal pain .
METHODS	A seven-month office ergonomic intervention study evaluated the effect of two engineering controls plus training on neck/UE pain and mechanical exposures in 113 computer workers , including a 3-month follow-up period .
METHODS	Participants were randomised into an intervention group , who received a keyboard/mouse tray ( KBT ) , touch pad ( TP ) for the non-dominant hand and keyboard shortcuts , and a control group who received keyboard shortcuts .
METHODS	Participants continued to have available a mouse at the dominant hand .
METHODS	Outcomes were pain severity , computer rapid upper limb assessment ( RULA ) , and hand activity level .
METHODS	Prevalence ratios ( PRs ) evaluated intervention effects using dichotomised pain and exposure scores .
RESULTS	In the intervention group , the dominnt proximal UE pain PR = 0.9 , 95 % CI 0.7 to 1.2 and the dominant distal UE PR = 0.8 , 95 % CI 0.5 to 1.3 , postintervention .
RESULTS	The non-dominant proximal UE pain PR = 1.0 , 95 % CI 0.8 to 1.4 , while the non-dominant distal UE PR = 1.2 , 95 % CI 0.6 to 2.2 , postintervention .
RESULTS	Decreases in non-neutral postures were found in two RULA elements ( non-dominant UE PR = 0.9 , 95 % CI 0.8 to 0.9 and full non-dominant RULA PR = 0.8 , 95 % CI 0.8 to 0.9 ) of the intervention group .
RESULTS	Hand activity increased on the non-dominant side ( PR = 1.4 , 95 % CI 1.2 to 1.6 ) in this group .
CONCLUSIONS	While the intervention reduced non-neutral postures in the non-dominant UE , it increased hand activity in the distal region of this extremity .
CONCLUSIONS	To achieve lower hand activity , a KBT and TP used in the non-dominant hand may not be the best devices to use .

###24357105
BACKGROUND	Brassica vegetable consumption may confer a protective effect against cancer , possibly attributable to their glucosinolates .
BACKGROUND	Glucobrassicin is a predominant glucosinolate and is the precursor of indole-3-carbinol ( I3C ) , a compound with anticancer effects .
BACKGROUND	However , objective assessments of I3C uptake from Brassica vegetables have not been successful .
METHODS	We conducted a randomized , crossover trial to test whether 3,3 ' - diindolylmethane ( DIM , a metabolite of I3C ) excreted in the urine after consumption of raw Brassica vegetables with divergent glucobrassicin concentrations is a marker of I3C uptake from such foods .
METHODS	Twenty-five subjects were fed 50 g of either raw `` Jade Cross '' Brussels sprouts ( high glucobrassicin concentration ) or `` Blue Dynasty '' cabbage ( low glucobrassicin concentration ) once daily for 3 days .
METHODS	All urine was collected for 24 hours after vegetable consumption each day .
METHODS	After a washout period , subjects crossed over to the alternate vegetable .
METHODS	Urinary DIM was measured using a novel liquid chromatography-electrospray ionization-tandem mass spectrometry-selected reaction monitoring ( LC-ESI-MS/MS-SRM ) method with [ ( 2 ) H2 ] DIM as internal standard .
RESULTS	Urinary DIM was consistently and significantly higher after Brussels sprouts feeding than after cabbage feeding , as evidenced by an average difference of 8.73 pmol/mg creatinine ( 95 % confidence interval , 5.36-12 .10 ; P = 0.00002 ) .
CONCLUSIONS	We have successfully quantified urinary DIM after uptake of I3C from food , and demonstrated that differences in glucobrassicin exposure are reflected in urinary DIM levels .
CONCLUSIONS	Our LC-ESI-MS/MS-SRM method and the results of our study indicate urinary DIM is a measure of I3C uptake from Brassica vegetables , a finding that can be utilized in prospective epidemiologic and chemoprevention studies .

###25212672
CONCLUSIONS	This study seeks to investigate the effect of electrical stimulation ( ES ) at dorsal root ganglion ( DRG ) on disuse bone loss in a rat model .
CONCLUSIONS	Hindlimb unloading for 14 days resulted in significant bone loss in rat tibia while rats with ES at DRG showed a significant reduced bone loss
BACKGROUND	Mechanical unloading induces osteoporosis in both human and animals .
BACKGROUND	Previous studies demonstrated that electrical stimulation ( ES ) to dorsal root ganglion ( DRG ) could trigger secretion of calcitonin gene-related peptide ( CGRP ) which plays an important role in bone modeling and remodeling .
BACKGROUND	This study seeks to investigate the effect of ES to DRG on disuse bone loss in a rat model .
METHODS	Twenty-four rats were randomly assigned in three experimental groups : cage control ( CC ) , hindlimb unloading ( HU ) , and hindlimb unloading with ES ( HUES ) .
METHODS	ES was applied via implantable micro-electrical stimulators ( IMES ) to right DRGs at vertebral levels L4-L6 in HUES group .
RESULTS	Hindlimb unloading for 14 days resulted in 25.9 % decrease in total bone mineral content ( BMC ) , 29.2 % decrease in trabecular BMD and trabecular microarchitecture and connectivity were significantly deteriorated in the proximal tibia metaphysis in HU group , while rats with ES at DRG showed significant reduced bone loss that there was 3.8 % increase in total BMC , 2.3 % decrease in trabecular BMD , and significant improvement in trabecular microarchitecture .
RESULTS	There was a concurrent enhancement of expression of CGRP in stimulated DRGs .
CONCLUSIONS	The results confirm the effect of ES at DRG on enhancing CGRP expression and suggest potential applications of IMES for the prevention and treatment of disuse bone loss .

###25208366
OBJECTIVE	To assess the anti-plaque and anti-gingivitis effects of a dentifrice containing 0.3 % triclosan , 2 % copolymer and 0.243 % ( 1,100 ppm ) sodium fluoride in subjects with moderate plaque-induced gingivitis .
METHODS	This was a single center , monadic study .
METHODS	Subjects had at least 20 teeth remaining in the functional dentition , excluding third molars .
METHODS	Following a baseline examination for plaque , gingival inflammation and bleeding , 75 qualified healthy adult males and females , ages 18-70 were selected to participate in the study .
METHODS	Dental prophylaxis was performed and subjects were provided with two tubes of toothpaste ( Colgate Total ) and a soft-bristle toothbrush ( Colgate Wave Toothbrush ) .
METHODS	The subjects were instructed to brush twice daily using a modified Bass brushing technique .
METHODS	At the end of the 6 - to 8-week period subjects returned for collection of clinical and subjective data .
RESULTS	75 subjects completed the study .
RESULTS	Both clinical and subjective reductions were significant .
RESULTS	The results showed statistically significant reductions in plaque index , gingival inflammation and bleeding on probing .
RESULTS	The overall conclusion was that Colgate Total was a comprehensive dentifrice that produced a significant reduction in gingivitis , plaque , and bleeding .

###24312305
BACKGROUND	Antimicrobial-induced thrombocytopenia is frequently described in the literature among critically ill patients .
BACKGROUND	Several antimicrobials have been implicated , although experimental evidence to demonstrate causality is limited .
BACKGROUND	We report , using a randomized trial , the potential of antimicrobials to induce thrombocytopenia .
METHODS	Randomized trial allocated patients to antimicrobial treatment according to standard - of-care ( SOC group ) or drug-escalation in case of procalcitonin increases ( high-exposure group ) .
METHODS	Patients were followed until death or day 28 .
METHODS	Thrombocytopenia defined as absolute ( platelet count 100 x 109/L ) or relative ( 20 % decrease in platelet count ) .
METHODS	Analyses were performed in the two randomized groups and as a merged cohort .
RESULTS	Of the 1147 patients with platelet data available , 18 % had absolute thrombocytopenia within the first 24 hours after admission to intensive care unit and additional 17 % developed this complication during follow-up ; 57 % developed relative thrombocytopenia during follow-up .
RESULTS	Absolute and relative thrombocytopenia day 1-4 was associated with increased mortality ( HR : 1.67 [ 95 % CI : 1.30 to 2.14 ] ; 1.71 [ 95 % CI : 1.30 to 2.30 ] , P < 0.0001 , respectively ) .
RESULTS	Patients in the high-exposure group received more antimicrobials including piperacillin/tazobactam , meropenem and ciprofloxacin compared with the SOC group , whereas cefuroxime was used more frequently in the SOC group ( p < 0.05 ) .
RESULTS	Risk of absolute and relative thrombocytopenia ( RR : 0.9 [ 0.7-1 .3 ] , p = 0.7439 ; 1.2 [ 1.0-1 .4 ] , p = 0.06 ; respectively ) , as well as absolute platelet count ( daily difference , high-exposure vs. SOC -1.7 [ -3.8 -0.5 ] , p = 0.14 ) was comparable between groups .
RESULTS	In observational analyses , use of ciprofloxacin and piperacillin/tazobactam predicted risk of relative thrombocytopenia ( vs. cefuroxime , RR : 2.08 [ 1.48-2 .92 ] ; 1.44 [ 1.10-1 .89 ] , respectively ) , however only ciprofloxacin were associated with a reduction in absolute platelet count ( p = 0.0005 ) .
CONCLUSIONS	High exposure to broad-spectrum antimicrobials does not result in a reduction in thrombocytopenia in critically ill patients .
CONCLUSIONS	However , single use of ciprofloxacin , and less so piperacillin/tazobactam , may contribute to a lower platelet count .
BACKGROUND	ClinicalTrials.gov NCT00271752 http://clinicaltrials.gov/ct2/show/NCT00271752 .

###24767094
BACKGROUND	Severe anemia ( SA , hemoglobin < 6 g/dl ) is a leading cause of pediatric hospital admission in Africa , with significant in-hospital mortality .
BACKGROUND	The underlying etiology is often infectious , but specific pathogens are rarely identified .
BACKGROUND	Guidelines developed to encourage rational blood use recommend a standard volume of whole blood ( 20 ml/kg ) for transfusion , but this is commonly associated with a frequent need for repeat transfusion and poor outcome .
BACKGROUND	Evidence is lacking on what hemoglobin threshold criteria for intervention and volume are associated with the optimal survival outcomes .
METHODS	We evaluated the safety and efficacy of a higher volume of whole blood ( 30 ml/kg ; Tx30 : n = 78 ) against the standard volume ( 20 ml/kg ; Tx20 : n = 82 ) in Ugandan children ( median age 36 months ( interquartile range ( IQR ) 13 to 53 ) ) for 24-hour anemia correction ( hemoglobin > 6 g/dl : primary outcome ) and 28-day survival .
RESULTS	Median admission hemoglobin was 4.2 g/dl ( IQR 3.1 to 4.9 ) .
RESULTS	Initial volume received followed the randomization strategy in 155 ( 97 % ) patients .
RESULTS	By 24-hours , 70 ( 90 % ) children in the Tx30 arm had corrected SA compared to 61 ( 74 % ) in the Tx20 arm ; cause-specific hazard ratio = 1.54 ( 95 % confidence interval 1.09 to 2.18 , P = 0.01 ) .
RESULTS	From admission to day 28 there was a greater hemoglobin increase from enrollment in Tx30 ( global P < 0.0001 ) .
RESULTS	Serious adverse events included one non-fatal allergic reaction and one death in the Tx30 arm .
RESULTS	There were six deaths in the Tx20 arm ( P = 0.12 ) ; three deaths were adjudicated as possibly related to transfusion , but none secondary to volume overload .
CONCLUSIONS	A higher initial transfusion volume prescribed at hospital admission was safe and resulted in an accelerated hematological recovery in Ugandan children with SA .
CONCLUSIONS	Future testing in a large , pragmatic clinical trial to establish the effect on short and longer-term survival is warranted .
BACKGROUND	ClinicalTrials.Gov identifier : NCT01461590 registered 26 October 2011 .

###24730399
OBJECTIVE	The objective of this study was to test the hypothesis that topical tetracaine would be safe to use for 24 hours and would not affect corneal healing , that patients would experience more pain relief , and that patients would perceive tetracaine to be more effective than saline eye drops for the treatment of pain caused by corneal abrasions .
METHODS	The study was a 12-month , prospective , double-blind , randomized trial of tetracaine versus saline set in the emergency department ( ED ) of a regional tertiary care teaching hospital .
METHODS	A total of 116 patients presenting with uncomplicated corneal abrasions were included in this study .
METHODS	The intervention was either undiluted , preservative-free , topical tetracaine hydrochloride 1 % or saline , applied up to every 30 minutes while awake for 24 hours .
METHODS	Main safety outcome measures were repeat ED examinations at 48 hours with fluorescein staining and slit-lamp examination , 1-week and 1-month telephone interviews with additional examinations as needed , and monitoring of charts for complications .
METHODS	Secondary outcome measures were 100-mm visual analogue scale ( VAS ) pain scores recorded every 2 hours while awake for 48 hours and patient-perceived overall effectiveness using a numeric rating scale ( NRS ) of 0 to 10 obtained during telephone interviews .
RESULTS	At least one follow-up encounter was completed on each of the 116 patients .
RESULTS	No complications specifically attributed to topical anesthetic use occurred in the 59 patients in the tetracaine group , and the binomial probability confidence interval ( CI ) of this occurring is 0 to 6.1 .
RESULTS	There was no significant difference in corneal healing as measured by the percentage of patients with persistent fluorescein uptake at 48 hours between the two groups ( 23.9 % vs. 21.3 % , difference = 2.6 % , 95 % CI = -14 % to 20 % , p = 0.761 ) or persistent symptoms at 48 hours ( 21.7 % vs. 21.3 % , difference = 0.4 % , 95 % CI = -16 % to 17 % , p = 0.957 ) .
RESULTS	There was no clinical difference in VAS pain scores between the groups .
RESULTS	Patients in the tetracaine group rated the study drugs ' overall effectiveness significantly higher on the NRS ( 7.7 vs. 3.9 ) compared to patients in the saline group ( difference = 3.9 , 95 % CI = 2.4 to 5.3 , p < 0.0005 ) .
CONCLUSIONS	Topical tetracaine used for 24 hours is safe , and while there was no significant difference in patient VAS pain ratings over time , patient surveys on overall effectiveness showed that patients perceived tetracaine to be significantly more effective than saline .

###25733465
BACKGROUND	Food insecurity is associated with deficits in child development and health , but little is known about how children 's specific food-insecurity experiences play out through nutritional and non-nutritional pathways that may compromise well-being .
OBJECTIVE	This study used child self-reports of food insecurity to examine the types of food-insecurity experiences that were most prevalent and the relations between child food insecurity ( CFI ) , child diet , and child physical activity ( PA ) .
METHODS	A total of 3605 fourth - and fifth-grade children whose schools participated in the Network for a Healthy California-Children 's PowerPlay !
METHODS	campaign completed 24-h diary-assisted recalls and surveys including items from the Child Food Security Assessment and questions about PA. .
METHODS	Data were analyzed by using regression and logistic regression models .
RESULTS	CFI was present in 60 % of the children and included experiences of cognitive , emotional , and physical awareness of food insecurity .
RESULTS	Greater levels of CFI were associated with higher consumption of energy , fat , sugar , and fiber and a diet lower in vegetables .
RESULTS	For instance , a child at the highest level of CFI , on average , consumed 494 kJ/d ( 118 kcal ) , 8 g/d of sugar , and 4 g/d of fat more than a food-secure child .
RESULTS	Higher CFI was associated with a marginally significant difference ( P = 0.06 ) in minutes of PA ( 17 min/d less for children at the highest level of CFI vs. those who were food secure ) and with significantly greater perceived barriers to PA. .
CONCLUSIONS	CFI is a troublingly frequent , multidomain experience that influences children 's well-being through both nutritional ( dietary ) and non-nutritional ( e.g. , PA ) pathways .
CONCLUSIONS	CFI may lead to poor-quality diet and less PA and their developmental consequences .
CONCLUSIONS	Practitioners should consider CFI when assessing child health and well-being and can do so by asking children directly about their CFI experiences .

###25926416
BACKGROUND	Prenatal supplementation with docosahexaenoic acid ( DHA ) has been shown to increase birth size , but it is unclear whether these differences translate into improved postnatal growth .
OBJECTIVE	We assessed the effect of prenatal supplementation with DHA on offspring weight , length , and body mass index ( BMI ) through 60 mo of age .
METHODS	We examined growth patterns ( height , weight , and BMI ) in a cohort of 802 Mexican children whose mothers participated in a randomized , controlled trial of daily supplementation with 400 mg/d of DHA or a placebo from week 18-22 of gestation through delivery , with the use of a longitudinal multilevel model of growth .
RESULTS	Overall , means SDs of height - , weight - , and BMI-for-age z scores relative to WHO growth standards at 60 mo were -0.49 0.91 , -1.15 1.07 and 0.13 1.11 , respectively .
RESULTS	There were no significant differences by treatment group ( all P > 0.05 ) for height , weight , or BMI at any age through 60 mo. .
RESULTS	Similarly , DHA did not affect the average growth or the trajectories for these measures through 60 mo. .
CONCLUSIONS	Prenatal DHA supplementation did not affect height , weight , or BMI through 60 mo of age .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT00646360 .

###25357145
OBJECTIVE	This study investigates the clinical effects of autologous conditioned plasma ( ACP ) injections and low-level laser application as therapy options for chronic lateral epicondylitis .
METHODS	A total of 52 patients with chronic lateral epicondylitis were evaluated in this study ; 26 of these patients received three ACP injections and the control group , with 26 patients , received 12 laser applications , with standardized physical therapy for all patients afterward .
METHODS	Control examinations took place before treatment , after 2 and 6 mos , and in the 1 yr final follow-up .
METHODS	The control examination included the visual analog scale for pain and Disabilities of the Arm , Shoulder and Hand outcome measure scores .
RESULTS	The analysis at final follow-up after 1 yr showed that both treatment options resulted in successful therapy outcome for the patients .
RESULTS	In total , 63.5 % were successfully treated .
RESULTS	Successful treatment was defined as more than 30 % improvement in the visual analog score and more than 10.2 points in the Disabilities of the Arm , Shoulder and Hand score .
RESULTS	Both groups showed a significant improvement in time response .
CONCLUSIONS	This study demonstrates the beneficial effects of autologous proliferative therapies in the treatment of lateral epicondylitis .
CONCLUSIONS	The data show that laser application and ACP therapy lead to a clinical improvement in epicondylopathia .
CONCLUSIONS	Especially the new treatment with ACP can be highlighted as an alternative and as an easy-to-apply therapy option for clinical practice .

###25730652
OBJECTIVE	The purpose of the present study was to evaluate the effects of superimposed electromyostimulation ( E ) during cycling on myokines and markers of muscle damage , as E might be a useful tool to induce a high local stimulus to skeletal muscle during endurance training without performing high external workloads .
METHODS	13 subjects participated in three experimental trials each lasting 60 min in a randomized order .
METHODS	1 ) Cycling ( C ) , 2 ) Cycling with superimposed E ( C+E ) and 3 ) E. Interleukin-6 ( IL-6 ) , brain-derived neurotrophic factor ( BDNF ) , creatine kinase ( CK ) and myoglobin were determined before ( pre ) and 0 ' , 30 ' , 60 ' , 240 ' and 24h after each intervention .
RESULTS	Only C+E caused significant increases in levels of CK and myoglobin .
RESULTS	BDNF and IL-6 significantly increased after C and C+E , however increases for IL-6 were significantly higher after C+E compared to C.
CONCLUSIONS	The present study showed that superimposed E during cycling might be a useful tool to induce a high local stimulus to skeletal muscle even when performing low to moderate external workloads .
CONCLUSIONS	This effect might be due the activation of additional muscle fibers and mild eccentric work due to the concomitant activation of agonist and antagonist .
CONCLUSIONS	However the higher load to skeletal muscle has to be taken into account .

###24474552
OBJECTIVE	Energy drinks are beverages containing vasoactive metabolites , usually a combination of caffeine , taurine , glucuronolactone and sugars .
OBJECTIVE	There are concerns about the safety of energy drinks with some countries banning their sales .
OBJECTIVE	We determined the acute effects of a popular energy drink , Red Bull , on cardiovascular and hemodynamic variables , cerebrovascular parameters and microvascular endothelial function .
METHODS	Twenty-five young non-obese and healthy subjects attended two experimental sessions on separate days according to a randomized crossover study design .
METHODS	During each session , primary measurements included beat-to-beat blood pressure measurements , impedance cardiography and transcranial Doppler measurements for at least 20min baseline and for 2h following the ingestion of either 355mL of the energy drink or 355mL of tap water ; the endothelial function test was performed before and two hours after either drink .
RESULTS	Unlike the water control load , Red Bull consumption led to increases in both systolic and diastolic blood pressure ( p < 0.005 ) , associated with increased heart rate and cardiac output ( p < 0.05 ) , with no significant changes in total peripheral resistance and without diminished endothelial response to acetylcholine ; consequently , double product ( reflecting myocardial load ) was increased ( p < 0.005 ) .
RESULTS	Red Bull consumption also led to increases in cerebrovascular resistance and breathing frequency ( p < 0.005 ) , as well as to decreases in cerebral blood flow velocity ( p < 0.005 ) and end-tidal carbon dioxide ( p < 0.005 ) .
CONCLUSIONS	Our results show an overall negative hemodynamic profile in response to ingestion of the energy drink Red Bull , in particular an elevated blood pressure and double product and a lower cerebral blood flow velocity .

###24506498
OBJECTIVE	While darbepoetin alfa ( DA ) can be administered once monthly ( QM ) to maintain haemoglobin ( Hb ) concentrations in anaemic patients with chronic kidney disease not on dialysis ( CKD-ND ) , the QM use of DA for anaemia correction has not been previously investigated .
METHODS	In this randomized , double-blind , non-inferiority , active-controlled study , adult subjects with CKD-ND , Hb levels < 10g/dL , and not treated with an erythropoiesis-stimulating agent were randomized 1:1 to receive DA every 2 weeks ( Q2W ) or QM for 33 weeks with initial doses of 0.75 g/kg Q2W or 1.5 g/kg QM .
METHODS	Subjects were treated to target Hb levels of 10-12g / dL and 1g/dL increase from baseline .
METHODS	The primary end-point was Hb change between baseline and the evaluation period ( weeks 29-33 ) , with a non-inferiority margin of -0.5 g/dL .
RESULTS	Three hundred and fifty-five subjects received 1 dose of DA .
RESULTS	Mean ( 95 % confidence interval [ CI ] ) change in Hb between baseline and the evaluation period was 2.16 ( 1.98-2 .33 ) g/dL for the Q2W group and 1.97 ( 1.80-2 .14 ) g/dL for the QM group , the mean ( 95 % CI ) difference in Hb change being -0.19 ( -0.43 to 0.05 ) g/dL .
RESULTS	Most subjects ( 97.9 % Q2W ; 98.1 % QM ) achieved a Hb level 10.0 g/dL and 1.0 g/dL increase in Hb from baseline .
RESULTS	Mean DA ( SD ) weekly equivalent doses over the evaluation period were 0.20 ( 0.23 ) and 0.27 ( 0.31 ) g/kg per week for the Q2W and QM groups , respectively .
RESULTS	Safety profiles were similar between groups .
CONCLUSIONS	In subjects with CKD-ND , QM dosing was non-inferior to Q2W dosing for anaemia correction and had a similar safety profile .

###24594247
OBJECTIVE	To compare the effect of semi-recumbent and sitting positions on gas exchange , respiratory mechanics and hemodynamics in patients weaning from mechanical ventilation .
BACKGROUND	Upright positions are encouraged during rehabilitation of the critically ill but there effects have not been well described .
METHODS	A prospective , randomized , cross-over trial was conducted .
METHODS	Subjects were passively mobilized from supine into a seated position ( out of bed ) and from supine to a semi-recumbent position ( > 45 backrest elevation in bed ) .
METHODS	Arterial blood gas ( PaO2/FiO2 , PaO2 , SaO2 , PaCO2 and A-a gradient ) , respiratory mechanics ( VE , VT , RR , Cdyn , RR/VT ) and hemodynamic measurements ( HR , MABP ) were collected in supine and at 5min and 30min after re-positioning .
RESULTS	Thirty-four intubated and ventilated subjects were enrolled .
RESULTS	The angle of backrest inclination in sitting ( 675 ) was greater than gained with semi-recumbent positioning ( 505 , p < 0.001 ) .
RESULTS	There were no clinically important changes in arterial blood gas , respiratory mechanic or hemodynamic values due to either position .
CONCLUSIONS	Neither position resulted in significant changes in respiratory and hemodynamic parameters .
CONCLUSIONS	Both positions can be applied safely in patients being weaned from ventilation .

###24857299
OBJECTIVE	To explore the optimal timing of tirofiban early treatment in ST-segment elevated acute myocardial infarction ( STEMI ) undergoing elective percutaneous coronary intervention ( PCI ) .
METHODS	A total of 118 consecutive STEMI patients were enrolled in the study .
METHODS	They were randomly assigned to the tirofiban early treatment group with tirofiban administrated routinely at 4 hours prior to angiography or the control group with tirofiban provisional administrated during or after angiography .
METHODS	Thrombolysis in myocardial infarction ( TIMI ) flow , creatine kinase MB isoenzyme ( CK-MB ) levels , acute thrombus events , efficacy and safety endpoints at Day 7 , Day 30 , 6 months and 1 year ( efficacy endpoints : death , myocardial infarction , target vessel revascularization and ischemic stroke ; safety endpoints : bleeding and thrombocytopenia ) were observed and compared between the two groups .
RESULTS	A total of 104 STEMI patients underwent elective PCI with 52 patients in each group and the baseline characteristics were balanced between the two groups .
RESULTS	Tirofiban was administered ( 5.9 2.9 ) hours earlier in the tirofiban early treatment group than the control group .
RESULTS	No statistical difference was observed between the two groups in TIMI flow before [ grade 0 : 18 ( 34.6 % ) vs 19 ( 36.5 % ) , grade 3 : 28 ( 53.8 % ) vs 27 ( 51.9 % ) ] and after PCI [ grade 3 : 52 ( 100.0 % ) vs 51 ( 98.1 % ) ] .
RESULTS	No difference was shown between the two groups in CK-MB levels before PCI [ ( 12.9 5.1 ) U/L vs ( 12.0 5.2 ) U/L , P > 0.05 ] ; and the increase of CK-MB 12-24 hours after PCI [ ( 1.0 6.2 ) U/L vs ( 2.3 8.3 ) U/L , P > 0.05 ] .
RESULTS	The incidence of acute thrombus events was similar ( 7.7 % vs 15.4 % , P > 0.05 ) .
RESULTS	No statistical difference was observed between the two groups in the efficacy endpoints at Day 7 ( 0.0 % vs 7.7 % , P > 0.05 ) , Day 30 ( 0.0 % vs 7.8 % , P > 0.05 ) , 6 months ( 2.0 % vs 9.8 % , P > 0.05 ) and 1 year ( 2.2 % vs 9.8 % , P > 0.05 ) .
RESULTS	Similar incidence was shown in the slight bleeding ( 15.4 % vs 5.8 % , P > 0.05 ) and the slight thrombocytopenia ( 0.0 % vs 1.9 % , P > 0.05 ) , while no severe to moderate bleeding or severe thrombocytopenia happened in both groups .
CONCLUSIONS	Tirofiban early treatment is not better than the tirofiban bailout treatment during or after PCI in STEMI patients undergoing elective PCI .
CONCLUSIONS	Trail registration ChiCTR-TRC-10000809 .

###25440560
OBJECTIVE	To investigate whether Sudarshan Kriya and related practices ( SK&P ) can lead to increased global assessment of functioning ( GAF ) and increased feeling of wellness in male prisoners with a non psychotic psychiatric disorder .
METHODS	This is a six month parallel randomized controlled study with sample size of 230 male prisoners .
METHODS	Participants meeting inclusion and exclusion criteria were assigned to a study or control group by simple random allocation in which random allocation sequence was generated using a random number table .
METHODS	Each individual study participant was involved in a daily program of SK&P for six weeks .
METHODS	Each individual control participant was instructed to sit in an armchair with his eyes closed and gentle attention to their breath for duration of six weeks .
METHODS	To be included in this study , a participant must be a male prisoner diagnosed to be suffering from a psychiatric disorder ( except psychosis and bipolar affective disorder [ BPAD ] ) by ICD-10 ( DCR ) criteria with age between 18 and 65 years .
RESULTS	Majority of subjects were unemployed married individuals , educated until undermatric level and not having occupational skills of more than an unskilled labor level .
RESULTS	Practicing SK&P for six weeks led to improvement in meanSD score of study participants in GAF , anxiety ( ANX ) , depressed mood ( DEP ) , positive well being ( PWB ) , general health ( GH ) , self control ( SC ) , vitality ( VT ) and total positive general well being ( PGWB ) .
RESULTS	Change in meanSD score of study participants when compared with control participants was statistically significant in terms of GAF , ANX , DEP , PWB , GH and PGWB .
RESULTS	Increase in SC and VT scores was statistically insignificant when compared with control participants .
CONCLUSIONS	Practicing SK&P helps in improving GAF , PWB , GH and total PGWB of an individual .
CONCLUSIONS	SK&P also causes significant reduction in anxiety and depression levels .
CONCLUSIONS	Effect of SK&P on SC and VT is insignificant .

###25891173
BACKGROUND	The immune checkpoint inhibitor ipilimumab is the standard-of-care treatment for patients with advanced melanoma .
BACKGROUND	Pembrolizumab inhibits the programmed cell death 1 ( PD-1 ) immune checkpoint and has antitumor activity in patients with advanced melanoma .
METHODS	In this randomized , controlled , phase 3 study , we assigned 834 patients with advanced melanoma in a 1:1:1 ratio to receive pembrolizumab ( at a dose of 10 mg per kilogram of body weight ) every 2 weeks or every 3 weeks or four doses of ipilimumab ( at 3 mg per kilogram ) every 3 weeks .
METHODS	Primary end points were progression-free and overall survival .
RESULTS	The estimated 6-month progression-free-survival rates were 47.3 % for pembrolizumab every 2 weeks , 46.4 % for pembrolizumab every 3 weeks , and 26.5 % for ipilimumab ( hazard ratio for disease progression , 0.58 ; P < 0.001 for both pembrolizumab regimens versus ipilimumab ; 95 % confidence intervals [ CIs ] , 0.46 to 0.72 and 0.47 to 0.72 , respectively ) .
RESULTS	Estimated 12-month survival rates were 74.1 % , 68.4 % , and 58.2 % , respectively ( hazard ratio for death for pembrolizumab every 2 weeks , 0.63 ; 95 % CI , 0.47 to 0.83 ; P = 0.0005 ; hazard ratio for pembrolizumab every 3 weeks , 0.69 ; 95 % CI , 0.52 to 0.90 ; P = 0.0036 ) .
RESULTS	The response rate was improved with pembrolizumab administered every 2 weeks ( 33.7 % ) and every 3 weeks ( 32.9 % ) , as compared with ipilimumab ( 11.9 % ) ( P < 0.001 for both comparisons ) .
RESULTS	Responses were ongoing in 89.4 % , 96.7 % , and 87.9 % of patients , respectively , after a median follow-up of 7.9 months .
RESULTS	Efficacy was similar in the two pembrolizumab groups .
RESULTS	Rates of treatment-related adverse events of grade 3 to 5 severity were lower in the pembrolizumab groups ( 13.3 % and 10.1 % ) than in the ipilimumab group ( 19.9 % ) .
CONCLUSIONS	The anti-PD-1 antibody pembrolizumab prolonged progression-free survival and overall survival and had less high-grade toxicity than did ipilimumab in patients with advanced melanoma .
CONCLUSIONS	( Funded by Merck Sharp & Dohme ; KEYNOTE-006 ClinicalTrials.gov number , NCT01866319 . )

###24294684
OBJECTIVE	The aim of this study was to evaluate the effectiveness of specially processed cereal ( SPC ) as a suitable adjunctive treatment for Meniere 's disease .
METHODS	We performed a randomized double-blinded , placebo-controlled , crossover study in a tertiary referral center of patients who had a diagnosis of Meniere 's disease based on the guidelines of the Committee on Hearing and Equilibrium of the American Academy of Otolaryngology-Head and Neck Surgery ( AAO-HNS ) .
METHODS	The main outcome measure was the AAO-HNS Functional Level Scale ( FLS ) .
RESULTS	Thirty-nine patients completed the study without any reported complications .
RESULTS	The mean pretreatment FLS score for the entire study cohort was 3.8 ( median , 4 ; range , 1 to 6 ) .
RESULTS	The overall FLS score improved significantly ( p < 0.001 ) , to 2.8 ( median , 3 ) , after SPC treatment .
RESULTS	No patients showed worsening on the FLS during SPC or placebo treatment .
RESULTS	Of the 39 patients , 23 showed improvement on the FLS , and no change was observed in the remaining 16 .
RESULTS	The median improvement on the FLS in these 23 patients was 2 points ( mean , 1.7 ; range , 1 to 4 ) .
RESULTS	The mean FLS score after placebo cereal treatment was not significantly different from baseline ( p = 0.452 ) , but was significantly higher than that after SPC treatment ( mean , 3.7 ; p < 0.001 ) .
RESULTS	The marginal difference observed between the baseline FLS score and the placebo FLS score was due to the fact that 5 patients reported 1-point improvements on the FLS after placebo treatment .
RESULTS	Nevertheless , significantly fewer patients improved on placebo than on SPC ( p < 0.001 ) .
CONCLUSIONS	Treatment with SPC appears to be well tolerated by most patients ( 91 % ) without any complications .
CONCLUSIONS	More than half ( 59 % ) of the study cohort reported subjective improvement in functional level .

###24262620
OBJECTIVE	This study sought to randomly compare cerebral protection with ANGIOGUARD ( Cordis Corporation , Bridgewater , New Jersey ) with Mo.Ma ( Invatec/Medtronic Vascular Inc , Santa Rosa , California ) during carotid artery stenting ( CAS ) , using diffusion-weighted magnetic resonance imaging ( DW-MRI ) to detect new ischemic cerebral lesions .
OBJECTIVE	The number , size , and location of lesions were analyzed .
BACKGROUND	The choice of the type of cerebral protection during CAS is controversial .
METHODS	From July 2008 to July 2011 , 60 patients undergoing CAS were randomized to ANGIOGUARD or Mo.Ma , distributed by chance , 30 patients for each group .
METHODS	All patients underwent DW-MRI before and after CAS .
METHODS	An independent neuroradiologist blinded to the cerebral protection used analyzed the images .
METHODS	Univariate and multivariate logistic models were fitted to analyze new ischemic lesions .
METHODS	Alternatively , a propensity score approach was used to reduce the bias due to differences between the groups .
METHODS	For the number of lesions , we used Poisson regression models .
RESULTS	New ischemic lesions seen on DW-MRI were present in 63.3 % of the ANGIOGUARD group versus 66.7 % of the Mo.Ma cohort ( p = 0.787 ) .
RESULTS	The number of ischemic cerebral lesions per patient , when present , was significantly lower in the Mo.Ma group ( a median of 6 lesions per patient vs. a median of 10 in the ANGIOGUARD , p < 0.001 ) .
RESULTS	Most lesions were small ( < 0.5 mm ) and localized in the ipsilateral territory .
RESULTS	One patient in the ANGIOGUARD group had a minor stroke during CAS ( 1.66 % ) .
CONCLUSIONS	New ischemic lesions seen on DW-MRI were present in both groups in > 60 % , but the number of lesions per patient was greater in the ANGIOGUARD group .
CONCLUSIONS	No death or disabling stroke occurred during at least 1 year of follow-up in both cohorts .

###24278915
OBJECTIVE	This double-blind randomized controlled trial assessed the effect of subgingival ozone ( O3 , gaseous ozone , HealOzone MK II , KaVo ) and/or hydrogen peroxide ( H2O2 ) on the development of peri-implant mucositis .
METHODS	Twenty subjects ( mean age , 60 7.7 years ) with 80 implants ( 4 implants each ) were recruited .
METHODS	First , a 2-week pretrial phase took place to achieve healthy gingiva .
METHODS	Subsequently , partial gum shields were constructed for the experimental area ( around the 4 implants ) ; subjects were asked to refrain from brushing in that area by wearing the gum shield .
METHODS	The following treatments were randomly applied ( for 60 seconds ) to implant sites on days 0 , 7 , and 14 : ( 1 ) air ( O2 ) and saline ( 0.9 % NaCl ) ( control group ) , ( 2 ) O2 and H2O2 ( 3 % ) , ( 3 ) O3 and saline , and ( 4 ) O3 and H2O2 .
METHODS	Plaque , gingival , and bleeding indices were recorded on days 0 , 7 , 14 , and 21 .
RESULTS	Significant differences were seen among the treatments ( P < .01 ) in plaque ( F = 16.68 ) , modified gingival ( F = 7.86 ) , and bleeding ( F = 18.42 ) indices .
RESULTS	O3 + saline and O3 + H2O2 produced optimum gingival health scores and were equally effective and the most effective in controlling bleeding ( mean score = 0.05 ) , while O2 + saline was the least effective ( mean score = 0.56 ) .
CONCLUSIONS	Ozone showed great potential for management of peri-implant mucositis .

###25287767
BACKGROUND	Cardiogenic shock ( CS ) complicating acute myocardial infarction ( AMI ) is associated with high mortality .
BACKGROUND	Previous studies regarding gender-specific differences in CS are conflicting and there are insufficient data for the presence of gender-associated differences in the contemporary percutaneous coronary intervention era .
BACKGROUND	Aim of this study was therefore to investigate gender-specific differences in a large cohort of AMI patients with CS undergoing contemporary treatment .
METHODS	In the randomized Intra-aortic Balloon Pump in Cardiogenic Shock II ( IABP-SHOCK II ) trial , 600 patients with CS complicating AMI undergoing early revascularization were assigned to therapy with or without intra-aortic balloon pump .
METHODS	We compared sex-specific differences in these patients with regard to baseline and procedural characteristics as well as short - and long-term clinical outcome .
RESULTS	Of 600 patients 187 ( 31 % ) were female .
RESULTS	Women were significantly older than men and had a significantly lower systolic and diastolic blood pressure at presentation ( p < 0.05 for all ) .
RESULTS	Diabetes mellitus and hypertension were more frequent in women , whereas smoking was more frequent in men ( p < 0.05 for all ) .
RESULTS	Women showed a higher mortality within the first day after randomization ( p = 0.004 ) .
RESULTS	However , after multivariable adjustment this numerical difference was no longer statistically significant .
RESULTS	No gender-related differences in clinical outcome were observed after 1 , 6 and 12 months of follow-up .
CONCLUSIONS	In this large-scale multicenter study in patients with CS complicating AMI , women had a worse-risk profile in comparison to men .
CONCLUSIONS	No significant gender-related differences in treatment as well as short - and long-term outcome were observed .

###25595508
BACKGROUND	Performing rigorously designed clinical trials in device-based treatments is challenging .
BACKGROUND	Continuous positive airway pressure ( CPAP ) is the most effective device-based treatment for obstructive sleep apnoea .
BACKGROUND	We performed a randomised crossover trial of CPAP versus placebo therapy and did not disclose the presence of placebo .
BACKGROUND	We assessed rates of staff unblinding , the likelihood of patient unblinding and obtained patient perceptions on lack of full disclosure .
METHODS	All patients ( n = 30 ) underwent a semi-structured exit interview .
METHODS	Prior to full disclosure patients were asked questions to ascertain whether they suspected one therapy was ineffective .
METHODS	The use of placebo was then disclosed and additional questions were administered to indicate the likelihood of unblinding had full disclosure occurred during consent .
METHODS	Staff unblinding was determined by means of a questionnaire that was completed after each patient encounter .
RESULTS	While the lack of full disclosure prevented patient unblinding during the trial , patients revealed a clear preference for active CPAP .
RESULTS	After disclosing the presence of placebo , 73 % ( n = 22 ) felt they would have been unblinded had they known at the start of the trial .
RESULTS	Only one patient described unease about the lack of full disclosure .
RESULTS	Staff thought they were unblinded in 6 % ( n = 16/282 ) of encounters .
RESULTS	They correctly identified the treatment device in 69 % of cases ( n = 11/16 , p < 0.001 ) .
CONCLUSIONS	Successful patient blinding was achieved , however this was probably reliant on the lack of full disclosure .
CONCLUSIONS	Staff unblinding occurred and highlights the difficulty with investigator blinding in device-based trials .
CONCLUSIONS	Ethical challenges in this type of study are likely to compromise research feasibility .
BACKGROUND	This clinical trial is registered with the Australian and New Zealand Clinical Trials Registry at http://www.anzctr.org.au ( ACTRN 12605000066684 ) .

###25039738
BACKGROUND	Closer clinical supervision has been increasingly promoted to improve patient care .
BACKGROUND	However , the continuous bedside presence of supervisors may threaten the model of progressive independence traditionally associated with effective clinical training .
BACKGROUND	Studies have shown favourable effects of closer supervision on trainees ' learning , but have not paid specific attention to the learning processes involved .
METHODS	We conducted a simulation-based study to explore the learning opportunities created during simulated resuscitation scenarios under different levels of supervision .
METHODS	Fifty-three residents completed a supervised scenario .
METHODS	Residents were randomised to one of three levels of supervision : telephone ( distant ) ; in-person after telephone consultation ( immediately available ) , and in-person from the beginning of the simulation ( direct ) .
METHODS	These interactions were converted into 234 pages of transcripts for analysis .
METHODS	We performed an inductive thematic analysis followed by a deductive analysis using situated learning theory as a theoretical framework .
RESULTS	Learning opportunities created during simulated scenarios were identified as belonging to either of two categories , incidental and engineered opportunities .
RESULTS	The themes resulting from this framework contributed to our understanding of trainees ' contributions to patient care , supervisors ' influences on patient care , and trainee-supervisor interactions .
RESULTS	All forms of supervision offered trainees incidental opportunities for practice , although the nature of these contributions could be affected by the bedside presence of supervisors .
RESULTS	Supervisors ' involvement in patient care by telephone and in person was associated with a shift of responsibility for patient care , but represented , respectively , engineered and incidental opportunities for observation .
RESULTS	In-person supervisor-trainee interactions added value to observation and created additional opportunities for incidental feedback and engineered practice .
CONCLUSIONS	The shift of responsibility for patient care occurred during both direct and distant supervision , and did not necessarily translate into a lack of opportunities for trainee participation and practice .

###25152605
OBJECTIVE	To evaluate the effect of muscovite in preventing small bowel injury induced by nonsteroidal anti-inflammatory drugs ( NSAIDs ) .
METHODS	We recruited and screened thirty-two healthy volunteers who were randomly allocated equally into two groups : an NSAID control group , who received 75 mg slow-release diclofenac , twice daily for 14 d ; and an NSAID-muscovite group , who received 3 g of muscovite in addition to the 75 mg of slow-release diclofenac , twice daily for 14 d. For gastroprotection , both groups were administered 20 mg/d of the proton pump inhibitor omeprazole .
METHODS	All eligible subjects underwent video capsule endoscopy ( CE ) prior to and 14 d after treatment .
RESULTS	Thirty subjects ( NSAID-muscovite group , n = 16 ; NSAID control group , n = 14 ) finally completed the whole trail .
RESULTS	At the baseline CE examination , no statistically significant differences between the two groups have been observed .
RESULTS	However , after 14 d of drug treatment , a significant difference was observed in the percentage of subjects with mucosal breaks when comparing the NSAID-muscovite group with the NSAID control group .
RESULTS	While 71.4 % ( 10/14 ) of subjects in the NSAID control group had at least one mucosal break , co-administration of muscovite in the NSAID-muscovite group reduced the rate to 31.3 % ( 5/16 ) ( P = 0.028 ) .
RESULTS	Moreover , higher number of mucosal breaks was found in the NSAID control group vs that in the NSAID-muscovite group ( P < 0.05 ) .
CONCLUSIONS	Muscovite co-therapy reduced the incidence of small intestinal injury after 14 d of diclofenac administration .

###25704429
BACKGROUND	Bursectomy , a traditional operative procedure to remove the peritoneal lining covering the pancreas and the anterior plane of the transverse mesocolon , has been performed for serosa-positive gastric cancer in Japan and Eastern Asia .
BACKGROUND	We conducted a multicenter , randomized , controlled trial to demonstrate the noninferiority of the omission of bursectomy .
METHODS	Between July 2002 and January 2007 , 210 patients with cT2-3 gastric adenocarcinoma were randomized intraoperatively to D2 gastrectomy with or without bursectomy .
METHODS	The primary endpoint was overall survival ( OS ) .
METHODS	We provide the results of the final analysis of the complete 5-year follow-up data .
RESULTS	After the median follow-up of 80 months , 5-year OS was 77.5 % for the bursectomy group and 71.3 % for the nonbursectomy group ( 2-sided P = .16 for superiority ; 1-sided P = .99 for noninferiority ) .
RESULTS	The hazard ratio for death in the nonbursectomy group was 1.40 ( 95 % CI , 0.87-2 .25 ) .
RESULTS	The 5-year recurrence-free survivals were 73.7 % and 66.6 % in the bursectomy and nonbursectomy groups , respectively ( 2-sided P = .33 for superiority ; 1-sided P = .99 for noninferiority ) .
RESULTS	Cox multivariate analysis revealed that bursectomy was an independent prognostic factor of good OS ( P = .033 ) .
RESULTS	Subgroup analysis showed a trend toward improved survival after bursectomy for tumors in the middle or lower third of the stomach and for pathologically serosa-positive tumors .
CONCLUSIONS	The final analysis could not demonstrate the noninferiority of the omission of bursectomy .
CONCLUSIONS	Bursectomy should not be abandoned as a futile procedure .

###24902473
OBJECTIVE	To assess the comparative efficacy and safety of pregabalin and levetiracetam for the reduction of seizure frequency in patients with partial seizures .
METHODS	This was a randomized , double-blind , flexible-dose , parallel-group noninferiority study of pregabalin and levetiracetam ( randomized 1:1 ) as adjunctive treatment in adult patients with refractory partial seizures .
METHODS	The study included a 6-week baseline phase , 4-week dose-escalation phase , and 12-week maintenance phase .
METHODS	The primary endpoint was the proportion of patients with a 50 % reduction in 28-day seizure rate during the 12-week maintenance phase , as compared with baseline .
METHODS	Noninferiority of pregabalin was declared if the lower limit of the 95 % confidence interval ( CI ) for the difference in responder rates was greater than the prespecified noninferiority margin of -12 % .
METHODS	A key secondary endpoint was the percent change from baseline in 28-day seizure rate during the dose-escalation and maintenance phases .
RESULTS	Five hundred nine patients were randomized to pregabalin ( n = 254 ) or levetiracetam ( n = 255 ) and 418 ( 208 pregabalin , 210 levetiracetam ) completed the maintenance phase .
RESULTS	With both pregabalin and levetiracetam , the proportion of patients with a 50 % reduction in 28-day seizure rate was 0.59 ( difference between groups [ 95 % CI ] , 0.00 [ -0.08 to 0.09 ] ) .
RESULTS	Because the lower bound of the 95 % CI was greater than the prespecified noninferiority margin of -12 % , pregabalin was not inferior to levetiracetam .
RESULTS	There was no significant difference between pregabalin and levetiracetam in the percent change in 28-day seizure rate ( median difference [ 95 % CI ] , 4.1 [ -2.6 to 10.9 ] , p = 0.3571 ) .
RESULTS	In a post hoc analysis , the proportion of patients who were seizure-free for the maintenance phase was lower with pregabalin ( 8.4 % ) than with levetiracetam ( 16.2 % ) , p = 0.0155 .
RESULTS	Safety profiles were similar and consistent with prior trials .
CONCLUSIONS	These results indicate that pregabalin is noninferior , and has a similar tolerability , to levetiracetam as adjunctive therapy in reducing seizure frequency in patients with partial seizures .

###24457276
OBJECTIVE	Nicorandil , an ATP sensitive potassium channel opener , may reduce the incidence of microvascular dysfunction after percutaneous coronary intervention ( PCI ) by dilating coronary resistance vessels .
OBJECTIVE	The aim of the study was evaluation of the impact of the administration of intravenous nicorandil on measuring the index of microcirculatory resistance ( IMR ) in PCI to patients with stable angina pectoris ( SAP ) .
RESULTS	Intravascular ultrasound ( IVUS ) , fractional flow reserve ( FFR ) , IMR and blood examination ( CK-MB ) , cardiac troponin I ( cTnI ) immediately post-PCI ( and 24 hours later ) were performed in 62 consecutive patients with SAP undergoing PCI .
RESULTS	FFR and IMR were measured simultaneously with a single coronary pressure wire .
RESULTS	IMR was defined as Pd/coronary flow ( or Pd * mean transit time ) at peak hyperaemia .
RESULTS	Patients were randomised to the control ( n = 29 ) , or nicorandil group ( n = 33 ) .
RESULTS	In the nicorandil group , nicorandil was intravenously administered as a 6 mg bolus injection just before PCI and as a constant infusion at 6 mg/hour for 24 hours thereafter .
RESULTS	All volumetric IVUS parameters and FFR were similar between the two groups both pre - and post-PCI .
RESULTS	However , IMR immediately post-PCI and cTnI 24 hours post-PCI were significantly higher in the control group compared to the nicorandil group ( IMR : 25.412.1 vs. 17.99.1 units , and cTnI : 0.210.13 vs. 0.120.08 ng/mL , for control vs. nicorandil ) .
RESULTS	The incidence for cTnI elevation more than fivefold the normal range ( > 0.20 ng/mL ) was significantly larger in the control group than in the nicorandil group ( 41 % vs. 12 % , p < 0.01 ) .
RESULTS	Additionally , the control group showed a closer correlation between plaque volume reduction during stenting as assessed by volumetric IVUS , and cTnI elevation than the nicorandil group ( r = 0.55 vs. 0.42 , p < 0.001 for control vs. nicorandil ) .
CONCLUSIONS	In patients undergoing successful coronary stenting for stable angina , administration of nicorandil is associated with reduced microvascular dysfunction induced by PCI .

###24951495
BACKGROUND	Methadone maintenance treatment ( MMT ) patients have an exceedingly high prevalence of tobacco use , and interventions that have been specifically developed for this vulnerable subpopulation have struggled to attain even modest rates of cessation .
BACKGROUND	A significant barrier has been an inability to initiate a quit attempt early in the treatment process and adherence to treatment .
METHODS	This study examined the extent to which self-efficacy , medication adherence , and other demographic and smoking variables predicted an early quit day in a sample of MMT smokers ( n = 315 ) enrolled in a smoking cessation pharmacotherapy trial .
METHODS	Using logistic regression , we estimated the association of having an early quit day-24hr without smoking during the first month of treatment .
RESULTS	Only 35.2 % of participants reported a successful early quit day .
RESULTS	The likelihood of an early quit day increased significantly ( odds ratio [ OR ] = 1.39 , 95 % CI = 1.04-1 .86 , p < .05 ) with education level and if a quit attempt was made in the past year ( OR = 2.27 , 95 % CI = 1.33-3 .87 , p < .01 ) .
RESULTS	Compared to the placebo arm , those randomized to either nicotine replacement therapy ( OR = 3.25 , 95 % CI = 1.30-8 .10 , p < .01 ) or varenicline ( OR = 3.16 , 95 % CI = 1.26-7 .92 ) were significantly more likely to have an early quit day .
RESULTS	The likelihood of an early quit day was also positively associated with adherence to the medication protocol ( OR = 2.05 , 95 % CI = 1.52-2 .76 ) .
CONCLUSIONS	Difficulty in achieving an early quit attempt may help explain the very low cessation rates found in studies of MMT smokers .

###26200977
BACKGROUND	Most women with breast cancer who undergo breast-conserving surgery receive whole-breast irradiation .
BACKGROUND	We examined whether the addition of regional nodal irradiation to whole-breast irradiation improved outcomes .
METHODS	We randomly assigned women with node-positive or high-risk node-negative breast cancer who were treated with breast-conserving surgery and adjuvant systemic therapy to undergo either whole-breast irradiation plus regional nodal irradiation ( including internal mammary , supraclavicular , and axillary lymph nodes ) ( nodal-irradiation group ) or whole-breast irradiation alone ( control group ) .
METHODS	The primary outcome was overall survival .
METHODS	Secondary outcomes were disease-free survival , isolated locoregional disease-free survival , and distant disease-free survival .
RESULTS	Between March 2000 and February 2007 , a total of 1832 women were assigned to the nodal-irradiation group or the control group ( 916 women in each group ) .
RESULTS	The median follow-up was 9.5 years .
RESULTS	At the 10-year follow-up , there was no significant between-group difference in survival , with a rate of 82.8 % in the nodal-irradiation group and 81.8 % in the control group ( hazard ratio , 0.91 ; 95 % confidence interval [ CI ] , 0.72 to 1.13 ; P = 0.38 ) .
RESULTS	The rates of disease-free survival were 82.0 % in the nodal-irradiation group and 77.0 % in the control group ( hazard ratio , 0.76 ; 95 % CI , 0.61 to 0.94 ; P = 0.01 ) .
RESULTS	Patients in the nodal-irradiation group had higher rates of grade 2 or greater acute pneumonitis ( 1.2 % vs. 0.2 % , P = 0.01 ) and lymphedema ( 8.4 % vs. 4.5 % , P = 0.001 ) .
CONCLUSIONS	Among women with node-positive or high-risk node-negative breast cancer , the addition of regional nodal irradiation to whole-breast irradiation did not improve overall survival but reduced the rate of breast-cancer recurrence .
CONCLUSIONS	( Funded by the Canadian Cancer Society Research Institute and others ; MA .20 ClinicalTrials.gov number , NCT00005957 . )

###25760561
BACKGROUND	Screening for lung cancer with low-dose spiral computed tomography ( LDCT ) has been shown to reduce lung cancer mortality by 20 % compared with screening with chest X-ray ( CXR ) in the National Lung Screening Trial , but uncertainty remains concerning the efficacy of LDCT screening in a community setting .
OBJECTIVE	To explore the effect of LDCT screening on lung cancer mortality compared with no screening .
OBJECTIVE	Secondary endpoints included incidence , stage , and resectability rates .
METHODS	Male smokers of 20 + pack-years , aged 60 to 74 years , underwent a baseline CXR and sputum cytology examination and received five screening rounds with LDCT or a yearly clinical review only in a randomized fashion .
RESULTS	A total of 1,264 subjects were enrolled in the LDCT arm and 1,186 in the control arm .
RESULTS	Their median age was 64.0 years ( interquartile range , 5 ) , and median smoking exposure was 45.0 pack-years .
RESULTS	The median follow-up was 8.35 years .
RESULTS	One hundred four patients ( 8.23 % ) were diagnosed with lung cancer in the screening arm ( 66 by CT ) , 47 of whom ( 3.71 % ) had stage I disease ; 72 control patients ( 6.07 % ) were diagnosed with lung cancer , with 16 ( 1.35 % ) being stage I cases .
RESULTS	Lung cancer mortality was 543per100 ,000 person-years ( 95 % confidence interval , 413-700 ) in the LDCT arm versus 544per100 ,000 person-years ( 95 % CI , 410-709 ) in the control arm ( hazard ratio , 0.993 ; 95 % confidence interval , 0.688-1 .433 ) .
CONCLUSIONS	Because of its limited statistical power , the results of the DANTE ( Detection And screening of early lung cancer with Novel imaging TEchnology ) trial do not allow us to make a definitive statement about the efficacy of LDCT screening .
CONCLUSIONS	However , they underline the importance of obtaining additional data from randomized trials with intervention-free reference arms before the implementation of population screening .

###24450487
BACKGROUND	Migraine headaches are a significant problem for American women with many of them suffering from headaches around the time of their menstrual cycle .
BACKGROUND	Women taking oral contraceptives in the standard 21/7 cycle regimen often suffer from headaches around the time of the hormone free intervals ( HFIs ) as well .
BACKGROUND	Extended oral contraceptive regimens have been shown to decrease the frequency , but not eliminate these headaches .
BACKGROUND	This study is a double-blind , randomized , placebo-controlled pilot study of participants with menstrual-related migraines ( MRMs ) who were initiated on extended combined oral contraceptives and given frovatriptan prophylactically during HFIs .
METHODS	Participants having spontaneous menstrual cycles or taking daily combined oral contraceptives in a 21/7 regimen with MRMs were placed on a contraceptive containing levonorgestrel and ethinyl estradiol .
METHODS	Analyses compared headache scores during pre-study baseline cycles to those in a 168-day extended regimen with placebo versus frovatriptan treatments during HFIs .
RESULTS	Daily headache scores decreased ( p = 0.034 ) from 1.29 0.10 during pre-study cycles to 1.10 0.14 during extended combined oral contraceptive use .
RESULTS	Frovatriptan blocked the increase in headache score over the placebo during HFIs .
RESULTS	However , following the withdrawal of frovatriptan , headache scores increased ( p > 0.01 ) despite resuming combined oral contraceptive use .
CONCLUSIONS	Extended combined oral contraceptive regimen reduces MRM severity .
CONCLUSIONS	Frovatriptan prevents headaches during HFIs , but is associated with new headache symptoms when withdrawn .

###24576259
OBJECTIVE	To compare the anaesthetic , analgesic and cardiorespiratory effects of intramuscular ( IM ) medetomidine and ketamine administered alone or combined with morphine or tramadol , for orchiectomy in cats .
METHODS	Randomised , blinded , prospective clinical study .
METHODS	Thirty client-owned cats .
METHODS	Cats ( n = 10 in each group ) received a combination of medetomidine ( 60 gkg ( -1 ) ) and ketamine ( 10 mg kg ( -1 ) ) alone ( MedK ) ; combined with morphine ( 0.2 mg kg ( -1 ) ) ( MedKM ) , or combined with tramadol ( 2 mg kg ( -1 ) ) ( MedKT ) IM .
METHODS	Time of induction , surgical and recovery events were recorded , and physiological parameters measured and recorded .
METHODS	Analgesia was evaluated with a visual analogue scale , a composite scoring system and the von Frey mechanical threshold device , every hour from three to eight hours post-drug administration injection .
METHODS	Data were analyzed with a linear mixed model , Kruskal-Wallis or Chi-square tests ( p < 0.05 ) .
RESULTS	Median ( IQR ) induction and recovery times ( minutes ) were not significantly ( p = 0.125 ) different between groups : 5.6 ( 2.7-8 .0 ) , 7.4 ( 5.1-9 .6 ) and 8.0 ( 5.8-14 .9 ) for induction and 128.5 ( 95.1-142 .8 ) , 166.4 ( 123.1-210 .0 ) and 142.9 ( 123.4-180 .2 ) for recovery , with MedK , MedKT and MedKM , respectively .
RESULTS	Two cats ( MedKM ) required alfaxalone for endotracheal intubation .
RESULTS	In all groups , three or four cats required additional isoflurane for surgery .
RESULTS	Arterial oxygen tension overall ( mean SD : 66 2 mmHg ) was low .
RESULTS	Surgery resulted in increased systolic arterial blood pressure ( p < 0.001 ) , haemoglobin saturation ( p < 0.001 ) , respiratory ( p = 0.003 ) and heart rates ( p = 0.002 ) .
RESULTS	Pain scores did not differ significantly between groups .
RESULTS	Von Frey responses decreased over time ; changes over time varied by treatment ( p < 0.001 ) , MedK returning to baseline values more rapidly than MedKM and MedKT .
RESULTS	No cat required rescue analgesics .
CONCLUSIONS	All three protocols can provide adequate anaesthesia and analgesia for orchiectomy in cats .
CONCLUSIONS	However , rescue intervention to maintain surgical anaesthesia may be required in some cats .
CONCLUSIONS	Oxygen supplementation is advised .

###26184850
OBJECTIVE	The value of frequent Carcino-Embryonic Antigen ( CEA ) measurements and CEA-triggered imaging for detecting recurrent disease in colorectal cancer ( CRC ) patients was investigated in search for an evidence-based follow-up protocol .
METHODS	This is a randomized-controlled multicenter prospective study using a stepped-wedge cluster design .
METHODS	From October 2010 to October 2012 , surgically treated non-metastasized CRC patients in follow-up were followed in eleven hospitals .
METHODS	Clusters of hospitals sequentially changed their usual follow-up care into an intensified follow-up schedule consisting of CEA measurements every two months , with imaging in case of two CEA rises .
METHODS	The primary outcome measures were the proportion of recurrences that could be treated with curative intent , recurrences with definitive curative treatment outcome , and the time to detection of recurrent disease .
RESULTS	3223 patients were included ; 243 recurrences were detected ( 7.5 % ) .
RESULTS	A higher proportion of recurrences was detected in the intervention protocol compared to the control protocol ( OR = 1.80 ; 95 % - CI : 1.33-2 .50 ; p = 0.0004 ) .
RESULTS	The proportion of recurrences that could be treated with curative intent was higher in the intervention protocol ( OR = 2.84 ; 95 % - CI : 1.38-5 .86 ; p = 0.0048 ) and the proportion of recurrences with definitive curative treatment outcome was also higher ( OR = 3.12 , 95 % - CI : 1.25-6 .02 , p-value : 0.0145 ) .
RESULTS	The time to detection of recurrent disease was significantly shorter in the intensified follow-up protocol ( HR = 1.45 ; 95 % - CI : 1.08-1 .95 ; p = 0.013 ) .
CONCLUSIONS	The CEAwatch protocol detects recurrent disease after colorectal cancer earlier , in a phase that a significantly higher proportion of recurrences can be treated with curative intent .

###24729145
OBJECTIVE	To monitor the development of graft vascularization after pterygium excision with conjunctival autograft transplantation ( CAT ) using indocyanine green angiography ( ICGA ) and to compare the graft vascularization between 2 different fixation techniques ( fibrin glue and sutures ) .
METHODS	A total of 26 eyes of 26 patients with primary pterygium were randomly assigned after pterygium excision as having either fibrin glue ( 13 eyes ) or Vicryl sutures ( 13 eyes ) for CAT .
METHODS	Anterior segment ICGA findings were evaluated postoperatively at 1 , 7 , and 15 days and the percentages of graft vascularization in both groups were compared using pixel analysis software program .
RESULTS	The mean SD age of patients in the suture and fibrin glue groups was 52.1 12.7 years and 57.1 9.82 years , respectively .
RESULTS	There was no statistically significant difference between the groups regarding age , sex , or follow-up ( p < 0.05 for all ) .
RESULTS	Also , the mean intraoperative defect size was not significantly different between the groups , which was measured as 20.11 10.44 mm2 in the suture group and 23.44 12.34 mm2 in the fibrin glue group ( p = 0.343 ) .
RESULTS	The mean percentage of vascularized graft area at postoperative day 1 and 7 was 18.1 7.8 % and 25.3 8.6 % in the suture group and 34.8 10.2 % and 66.1 17.8 % in the fibrin glue group .
RESULTS	The difference between the groups was statistically significant ( p < 0.01 for both ) .
RESULTS	At postoperative day 15 , all grafts were 100 % perfused in both groups .
CONCLUSIONS	Fibrin glue fixation of conjunctival autografts led to more vascularization in the early postoperative period than suture fixated grafts , which in turn may have significance in terms of graft health and pterygium recurrence .

###24360107
OBJECTIVE	To explore the effects of parecoxib sodium multimode analgesia on postoperative analgesia in patients undergoing laparoscopic cholecystectomy ( LC ) .
METHODS	A prospective , double-blind , randomized and placebo-controlled study was conducted on 80 patients undergoing elective LC at Department of Endoscopic Surgery , First Affiliated Hospital , Wenzhou Medical College from March 2011 to June 2011 .
METHODS	They were randomized to receive either 40 mg parecoxib infusion 30 min preoperative and at 12 , 24 , 36 , 48 h post-operation ( treatment group ) .
METHODS	And 2 ml normal saline infusion was administered similarly as a placebo ( control group ) .
METHODS	All patients received ropivacaine infusion at port sites at the end of LC .
METHODS	The degree of postoperative pain was assessed with visual analog scale ( VAS ) at 1 , 2 , 4 , 8 , 12 , 24 , 36 , 48 h post-operation respectively .
METHODS	The consumption of pethidine in the first 24 h post-operation was also recorded .
RESULTS	The VAS pain scores at each timepoint were significantly lower in the treatment group than those in the control group ( 1 h : 1.0 0.6 vs 1.8 0.6 , t = -1.650 , P = 0.000 ; 2 h : 1.3 0.6 vs 1.9 0.7 , t = -4.302 , P = 0.000 ; 4 h : 1.6 0.7 vs 2.7 1.2 , t = -4.752 , P = 0.000 ; 8 h : 2.5 1.4 vs 5.0 1.8 , t = -6.835 , P = 0.000 ; 12 h : 2.2 1.1 vs 3.3 1.5 , t = -3.902 , P = 0.000 ; 24 h : 1.6 0.8 vs 2.5 1.4 , t = -3.649 , P = 0.000 ; 36 h : 1.2 0.6 vs 2.2 0.8 , t = -6.390 , P = 0.000 ; 48 h : 1.0 0.5 vs 1.5 0.6 , t = -3.710 , P = 0.000 ) .
RESULTS	And the amount of pethidine used in the first 24h after LC was also less in the treatment group ( 150 vs 950 mg , ( 2 ) = 16.200 , P = 0.000 ) .
CONCLUSIONS	The infusion multimode analgesia of parecoxib sodium 40 mg provides significant effect of postoperative pain relief after laparoscopic cholecystectomy .

###24597608
OBJECTIVE	In this study we aimed to assess the feasibility and safety of fast-track surgery ( FTS ) combined with laparoscopy for treating patients with rectal cancer and compare the results with those of the conventional perioperative intervention group .
METHODS	A total of 120 patients with rectal cancer were prospectively randomly assigned to the FTS combined with laparoscopy group and the conventional perioperative intervention plus laparoscopy group from November 2011 to November 2012 .
METHODS	All patients received radical anterior resection with total mesorectal excision .
METHODS	Their baseline characteristics and the perioperative outcomes were recorded for analyses .
RESULTS	Compared with the conventional perioperative intervention group , the fast-track protocol combined with laparoscopy could shorten the time to the first flatus ( 53.4423.64 h vs 67.8520.12 h , P = 0.001 ) and first defecation ( 65.2322.24 h vs 86.9824.85 h , P = 0.000 ) after operation , accelerate the decrease of white blood cell count ( P < 0.05 ) , inhibit body temperature augmentation ( P < 0.05 ) and reduce postoperative complication rate ( 16.9 % vs 3.5 % , P = 0.030 ) .
RESULTS	In addition , the length of postoperative stay was also shortened ( 5.051.38 days vs 6.982.26 days , P = 0.000 ) .
RESULTS	The medical cost of hospitalization was also reduced in the FTS group .
CONCLUSIONS	FTS in combination with laparoscopy may accelerate the clinical recovery of patients with rectal cancer after surgery .

###25240757
BACKGROUND	Plant-made biotherapeutics are gathering momentum and some plant glycoproteins are allergens .
BACKGROUND	Glycans with core 1-2xylose and 1,3 fucose motifs and antennae terminated by mannose residues ( e.g. : MMXF ) are found on several plant allergens and can cross-react with glyco-epitopes from other sources .
BACKGROUND	To date , reactivity to these cross-reactive determinants has not been associated with clinical symptoms .
OBJECTIVE	We produced VLP vaccines bearing the hemagglutinin ( HA ) of H5 ( A/Indonesia/5 / 05 ) or H1 ( A/California/07 / 09 ) influenza viruses by transfection of Nicotiana benthamiana .
OBJECTIVE	Subjects enrolled in Phase I/II trials were followed for evidence of allergy/hypersensitivity and development of antibodies against plant glyco-epitopes .
METHODS	A total of 280/349 subjects received either one ( H1 ) or 2 doses ( H5 ) of vaccine ( 5-45 g of HA/dose ) intramuscularly including 40 with pre-existing plant allergies .
METHODS	Subjects were monitored for 6 months .
METHODS	IgG and IgE to plant glyco-epitopes were measured by ELISA using corn - / egg-derived avidin and bromelain as target antigens .
RESULTS	No subject developed allergic/hypersensitivity symptoms .
RESULTS	Some ( 34 % ) developed transient IgG and , in some cases IgE , to plant glyco-epitopes but no subject mounted an IgE response to the MMXF motif .
RESULTS	Antibodies returned to baseline by 6 months in most subjects .
CONCLUSIONS	VLP vaccines bearing influenza HA glycoproteins can elicit transient IgG and , in some cases , IgE responses that are not associated with either the development or worsening of allergic/hypersensitivity symptoms .

###24385640
OBJECTIVE	Cognitive training has been shown to improve both cognitive and everyday abilities in older adults ; however , little is known concerning the amount of training needed or the characteristics of those who benefit .
OBJECTIVE	These analyses examined the longitudinal impact of dosage ( number of training sessions ) on the improvement and maintenance of cognitive and everyday function .
METHODS	ACTIVE is a longitudinal , randomized , single-blind clinical trial evaluating cognitive interventions in older adults ( aged 65-94 ) from six states in the United States .
RESULTS	Latent growth curve models indicated that initial training effects were maintained over 5 years and amplified by booster sessions .
RESULTS	A single booster session counteracted 4.92 months of age-related processing speed decline .
CONCLUSIONS	Cognitive performance improved by 2.5 standard deviations for participants who attended all 10 initial sessions and all 8 booster sessions compared to randomized participants who attended none .
CONCLUSIONS	Implications for the broader application of cognitive training interventions are discussed .

###25728731
BACKGROUND	Galectin-3 is a prognostic heart failure biomarker associated with aldosterone-induced myocardial fibrosis ; mineralocorticoid receptor antagonists ( MRAs ) may reduce such fibrosis .
BACKGROUND	We sought to examine outcomes of patients with heart failure with reduced ejection fraction ( HFrEF ) as a function of galectin-3 and MRA therapy .
METHODS	A total of 151 patients with chronic HFrEF were categorized by baseline galectin-3 and subsequent MRA therapy trends with regard to cardiovascular ( CV ) events , left ventricular remodeling , safety , and quality of life , over a mean of 10 months .
RESULTS	Although galectin-3 > 20 ng/mL was associated with doubling in adjusted risk for CV events , regardless of MRA treatment , there was no difference in CV event rates with regard to MRA use patterns , independent of galectin-3 concentrations .
RESULTS	Specifically , in patients with elevated galectin-3 treated with intensified MRA therapy , a significant difference was not detected in CV event rates ( P = .79 ) or the cumulative number of such events ( P = .76 ) .
RESULTS	Adjusted analysis revealed no difference in time to first CV event if MRA was added/intensified in those with elevated galectin-3 ( hazard ratio 0.99 , 95 % CI 0.97-1 .02 , P = .74 ) ; similarly , cumulative MRA dose was not a specific predictor of benefit .
RESULTS	In those with elevated galectin-3 , MRA therapy did not affect left ventricular remodeling indices or quality of life at follow-up ; these patients had the highest rates of treatment-related adverse events with intensified MRA use .
RESULTS	Regardless of MRA use , elevated galectin-3 was associated with more significant renal dysfunction .
CONCLUSIONS	Among patients with chronic HFrEF and elevated galectin-3 concentrations , we found no specific benefit from addition or intensification of MRA therapy .

###24992753
OBJECTIVE	To observe the curative effect of acupuncture at hour-prescriptive points , a method of midnight-noon ebb-flow , to treat female adult abdominal obesity with spleen deficiency and exuberant dampness .
METHODS	Seventy-two patients with adult abdominal obesity with spleen deficiency and exuberant dampness were randomly divided into a treatment group and a control group with 36 patients in each group .
METHODS	Patients in the treatment group were treated with acupuncture at hour-prescriptive points from 9 to 11 AM every day on the principle of taking points along channels in time .
METHODS	Patients in the control group were treated with acupuncture at any time beyond 9 to 11 AM .
METHODS	Patients in both groups were treated for three courses of treatment .
RESULTS	The total effective rate was 87.5 % in the treatment group and 78.8 % in the control group .
RESULTS	The total curative effect in the treatment group was significantly better than that in the control group in reducing body weight , body mass index , waistline , obesity level , and clinical symptoms ( P < 0.05 ) .
RESULTS	After treatment , t-test was used on two independent samples to analyze the ratio of waistline to hipline and hipline .
RESULTS	A value of 0.01 < P < 0.05 expressed a weaker outcome and similar curative effect between the two groups in reducing ratio of waistline to hipline and hipline of patients .
RESULTS	This value indicates that the treatment group has no obvious superiority to that of the control group for curative effect .
CONCLUSIONS	Because it was superior in reducing waistline and body weight of female adult patients suffering from abdominal obesity with spleen deficiency and exuberant dampness , acupuncture at hour-prescriptive points , a method of midnight-noon ebb-flow , is an effective method to treat obesity .

###24382344
OBJECTIVE	To evaluate how an intervention , which combined hand washing promotion aimed at 5-year-olds with provision of free soap , affected illnesses among the children and their families and children 's school absenteeism .
METHODS	We monitored illnesses , including diarrhoea and acute respiratory infections ( ARIs ) , school absences and soap consumption for 41 weeks in 70 low-income communities in Mumbai , India ( 35 communities per arm ) .
RESULTS	Outcomes from 847 intervention households ( containing 847 5-year-olds and 4863 subjects in total ) and 833 control households ( containing 833 5-year-olds and 4812 subjects ) were modelled using negative binomial regression .
RESULTS	Intervention group 5-year-olds had fewer episodes of diarrhoea ( -25 % , 95 % confidence intervals [ CI ] = -37 % , -2 % ) , ARIs ( -15 % , 95 % CI = -30 % , -8 % ) , school absences due to illnesses ( -27 % , 95 % CI = -41 % , -18 % ) and eye infections ( -46 % , 95 % CI = -58 % , -31 % ) .
RESULTS	Further , there were fewer episodes of diarrhoea and ARIs in the intervention group for ` whole families ' ( -31 % , 95 % CI = -37 % , -5 % ; and -14 % , 95 % CI = -23 % , -6 % , respectively ) , 6 - to 15-year-olds ( -30 % , 95 % CI = -39 % , -7 % ; and -15 % , 95 % CI = -24 % , -6 % ) and under 5 s ( -32 % , 95 % CI = -41 % , -4 % ; and -20 % , 95 % CI = -29 % , -8 % ) .
CONCLUSIONS	Direct-contact hand washing interventions aimed at younger school-aged children can affect the health of the whole family .
CONCLUSIONS	These may be scalable through public-private partnerships and classroom-based campaigns .
CONCLUSIONS	Further work is required to understand the conditions under which health benefits are transferred and the mechanisms for transference .

###24957215
BACKGROUND	Canine babesiosis due to Babesia canis is an endemic disease in many European countries .
BACKGROUND	A vaccine is available in some countries , but it does not prevent the infection and just helps in reducing the gravity of clinical signs .
BACKGROUND	Therefore , the major way to help preventing the disease is by controlling tick infestations on dogs.To assess the preventive efficacy of afoxolaner ( NexGard ) , a new oral anti- flea and tick product , against Babesia canis infected adult Dermacentor reticulatus in an experimentally controlled study .
METHODS	Sixteen healthy mixed breed adult dogs , negative for Babesia canis antibodies were included in a single centre , randomized , blinded and controlled study to evaluate the impact of treatment with afoxolaner on the transmission of Babesia canis to dogs exposed to Dermacentor reticulatus .
METHODS	The dogs were randomly allocated into two groups of 8 dogs each .
METHODS	One group remained untreated .
METHODS	In the other group , dogs were treated orally with a novel formulation of afoxolaner ( NexGard ) on day 0 .
METHODS	All dogs were infested each by 50 adult Dermacentor reticulatus ticks ( equal sex ratio ) at days 7 , 14 , 21 and 28 .
METHODS	The Dermacentor reticulatus ticks were confirmed to harbour Babesia canis by Polymerase Chain Reaction ( PCR ) .
RESULTS	The treatment was well tolerated by all dogs without any adverse effects .
RESULTS	Babesia canis was transmitted by D. reticulatus to all untreated control dogs , confirmed following demonstration of hyperthermia , detection of B. canis parasites in blood smears and PCR assay from blood and serology .
RESULTS	These confirmed infected dogs were subsequently treated with imidocarb and diminazene .
RESULTS	The treated dogs remained negative based on all criteria until the last study , Day 56 , confirming that the oral treatment of dogs with NexGard prevented transmission of Babesia canis and development of clinical babesiosis for up to 28 days .
CONCLUSIONS	This is the first demonstration that an oral acaricidal treatment may prevent the transmission of a pathogen despite the need for the tick to attach and start feeding before being killed by the acaricide .

###24405341
BACKGROUND	Medical trainees have identified stress as an important contributor to their medical errors in acute care environments .
OBJECTIVE	The objective of this study was to determine if the addition of acute stressors to simulated resuscitation scenarios would impact on residents ' simulated clinical performance .
METHODS	Fifty-four residents completed a control and a high-stress simulated scenario on separate visits .
METHODS	Stress measures were collected before and after scenarios .
METHODS	Two assessors independently evaluated residents ' videotaped performance .
RESULTS	Both control and high-stress scenarios triggered significant stress responses among participants ; however , stress responses were not significantly different between control and high-stress conditions .
RESULTS	No difference in performance was found between control and high-stress conditions ( F value = 2.84 , p = .098 ) .
CONCLUSIONS	Residents exposed to simulated resuscitation scenarios experienced significant stress responses irrespective of the presence of acute stressors during these scenarios .
CONCLUSIONS	This anticipatory stressful response could impact on resident learning and performance and should be further explored .

###24237879
BACKGROUND	This prospective , randomized , double-blind study was designed to evaluate the use of intranasally administered dexmedetomidine vs intranasal midazolam as a premedication in children undergoing complete dental rehabilitation .
METHODS	Seventy-two children of American Society of Anesthesiology classification ( ASA ) physical status ( I & II ) , aged 3-6 years , were randomly assigned to one of two equal groups .
METHODS	Group M received intranasal midazolam ( 0.2 mgkg ( -1 ) ) , and group D received intranasal dexmedetomidine ( 1 gkg ( -1 ) ) .
METHODS	The patients ' sedation status , mask acceptance , and hemodynamic parameters were recorded by an observer until anesthesia induction .
METHODS	Recovery conditions , postoperative pain , and postoperative agitation were also recorded .
RESULTS	The median onset of sedation was significantly shorter in group M 15 ( 10-25 ) min than in group D 25 ( 20-40 ) min ( P = 0.001 ) .
RESULTS	Compared with the children in group M , those in group D were significantly more sedated when they were separated from their parents ( 77.8 % vs 44.4 % , respectively ) ( P = 0.002 ) .
RESULTS	Satisfactory compliance with mask application was 58.3 % in group M vs 80.6 % in group D ( P = 0.035 ) .
RESULTS	The incidences of postoperative agitation and shivering were significantly lower in Group D compared with group M. Thirteen children ( 36.1 % ) in group M , showed signs of nasal irritation with teary eyes , and none of these signs was seen in the children in group D ( P = 0.000 ) .
RESULTS	There were no incidences of bradycardia , hypotension , in either of the groups during study observation .
CONCLUSIONS	Intranasal dexmedetomidine ( 1 gkg ( -1 ) ) is an effective and safe alternative for premedication in children ; it resulted in superior sedation in comparison to 0.2 mgkg ( -1 ) intranasal midazolam .
CONCLUSIONS	However , it has relatively prolonged onset of action .

###24736677
OBJECTIVE	To examine the effectiveness , acceptability and sustainability of interventions to reduce vitamin B12 ( B12 ) deficiency in South Asian women before conception .
METHODS	A 6-month randomised controlled trial conducted in Auckland , New Zealand .
METHODS	Participants ( 62 South Asian women , 18-50 years old ) were stratified by dietary practices , then randomised to three treatment groups : B12 Supplement ( oral cyanocobalamin 6g/day ) ( n = 21 ) , Placebo ( n = 21 ) , or B12 Dietary Advice ( n = 20 ) .
METHODS	Primary outcome measures were changes in B12 biomarkers ( serum B12 and holotranscobalamin ( holoTC ) ) at 6 months .
METHODS	Dietary B12 intake was estimated from a B12 food-specific frequency questionnaire ( B12FFQ ) .
METHODS	Intention-to-treat analysis was applied using ` last observation carried forward ' method .
METHODS	Changes in B12 biomarkers by treatment were compared using analysis of variance .
METHODS	Pearson 's correlations tested relationships between dietary B12 intake and B12 biomarkers .
RESULTS	At baseline , 48 % of women tested as insufficient or deficient in serum B12 ( < 222pmol/l ) and 51 % as insufficient or deficient in holoTC ( < 45pmol/l ) .
RESULTS	B12 status was moderately correlated with dietary B12 intake ( r = 0.5 , 95 % confidence interval ( CI ) ( 0.3-0 .7 ) ) and 44 % of women reported insufficient dietary intake ( < 2.4 g/day ) .
RESULTS	B12 Supplement was the only treatment group to record a significant increase in B12 biomarkers over 6 months : serum B12 by 30 % ( 95 % CI ( 11-48 % ) ) and holoTC by 42 % ( 12-72 % ) .
CONCLUSIONS	The prevalence of B12 insufficiency among Auckland South Asian women is high and moderately correlated with inadequate intake of foods that contain B12 .
CONCLUSIONS	Cyanocobalamin supplementation ( 6g/day ) was associated with improved B12 biomarkers , with a potential to improve preconception B12 status in South Asian women .

###24506739
OBJECTIVE	To compare the results of combined non-penetrating deep sclerectomy with phacoemulsification ( Phaco-NPDS ) to those of non-penetrating deep sclerectomy ( NPDS ) alone .
METHODS	Fifty-two eyes with cataract and primary open angle glaucoma ( POAG ) or pseudoexfoliative glaucoma ( PXG ) were randomly assigned to either Phaco-NPDS or NPDS .
METHODS	Follow-up was performed at regular intervals for up to 36 months .
METHODS	Complete success was defined as intraocular pressure ( IOP ) < 21mmHg without medication and qualified success was defined as IOP < 21mmHg with medication .
RESULTS	Mean IOP in the Phaco-NPDS group decreased from 23.07.8 mmHg to 14.12.8 mmHg and in the NPDS group from 23.5 5.1 to 14.62.2 mmHg 24 months after surgery .
RESULTS	The decreases of IOP in the postoperative period were statistically significant in both groups ( p < 0.05 ) .
RESULTS	There was no significant IOP difference between Phaco-NPDS and NPDS patients postoperatively ( p > 0.05 ) .
RESULTS	The mean number of glaucoma medications decreased from 1.81.3 to 0.150.4 and from 1.71.4 to 0.220.6 in the Phaco-NPDS and NPDS groups , respectively .
RESULTS	The decreases in the mean number of the anti-glaucoma medications at the end of the postoperative , 24-month follow-up period were found to be statistically significant for both Phaco-NPDS and NPDS groups ( p < 0.05 ) .
RESULTS	Mean BCVA increased significantly in both groups .
RESULTS	However , the visual outcome was significantly better for the Phaco-NPDS group ( p < 0.05 ) .
RESULTS	The complete and qualified success rates were 65.3 % and 88.4 % for Phaco-NPDS patients and 73.1 % and 92.3 % for NPDS patients , respectively ( p > 0.05 ) .
CONCLUSIONS	Phaco-NPDS surgery achieved excellent IOP control , while also providing immediate visual recovery .
CONCLUSIONS	The success rate was similar to that of the NPDS procedure alone .
CONCLUSIONS	It is advisable to consider Phaco-NPDS as a primary surgery for patients with coexisting cataract and open angle glaucoma , including PXG .

###25433676
BACKGROUND	Depression is a major public health problem that affects both individuals and society .
BACKGROUND	Previous studies report that university teachers are particularly susceptible to high levels of occupational stress and depressive symptoms .
BACKGROUND	The aims of this study were to explore the association between occupational stress and depressive symptoms in a group of university teachers , and assess the mediating role of psychological capital between these variables .
METHODS	A cross-sectional study was performed between November 2013 and January 2014 .
METHODS	Teachers from six universities were randomly sampled in Shenyang .
METHODS	The Center for Epidemiologic Studies Depression Scale , effort-reward imbalance scale , and psychological capital questionnaire ( PCQ-24 ) , as well as questions about demographic and working factors , were administered in questionnaires distributed to 1,500 university teachers .
METHODS	Completed questionnaires were received from 1,210 participants .
METHODS	Hierarchical linear regression analysis was used to examine the mediating role of psychological capital .
RESULTS	In the present study , 58.9 % ( 95 % CI ( Confidence Intervals ) : 56.1 % to 61.7 % ) of university teachers had a CES-D score equal to or above the cut-off of 16 .
RESULTS	Both effort-reward ratio ( ERR ) and scores of over-commitment were positively associated with depressive symptoms , whereas psychological capital was negatively associated with depressive symptoms among university teachers .
RESULTS	Psychological capital partially mediated the relationship between occupational stress and depressive symptoms .
CONCLUSIONS	Among Chinese university teachers , occupational stress may be a risk factor for depressive symptoms , whereas psychological capital might be protective against depressive symptoms .
CONCLUSIONS	Our results suggest that college administrators could support the development of psychological capital in their staff to alleviate depressive symptoms .

###26200930
OBJECTIVE	To examine the associations between amyloid - brain deposition and physical activity ( PA ) in elderly adults without dementia and to investigate whether the association has a dose-response relationship .
METHODS	Cross-sectional study .
METHODS	French community-dwelling people .
METHODS	Elderly adults with normal or mildly impaired cognition ( mean age 74.7 4.2 ; 60.4 % female ) with available information on current self-reported PA and amyloid - brain deposition measured using positron emission tomography ( PET ) using the PET-ligand florbetapir F 18 ( n = 268 ) .
METHODS	A standardized uptake value ratio ( SUVR ) was obtained for each subject .
METHODS	Participants were divided according to amyloid plaque cortical retention defined according to a SUVR cutoff of 1.10 ( SUVR + vs SUVR - ) .
RESULTS	Bivariate and multivariate analyses showed that PA was not significantly associated with SUVR .
RESULTS	SUVR + and SUVR - participants did not differ in terms of volume ( continuous PA variables ) and levels ( categorical PA variables ) of PA. .
RESULTS	PA was not correlated with SUVR in apolipoprotein E 4 carriers or noncarriers .
RESULTS	PA was not associated with cognitive function .
CONCLUSIONS	Although PA protects against dementia , there is no solid evidence that this protection involves a reduction in amyloid - brain deposition .
CONCLUSIONS	Further studies are needed to determine whether PA ( ideally measured at several time-points using objective measures ) is involved in the pathophysiology of Alzheimer 's disease .

###24813581
BACKGROUND	Forearm blood pressures have been suggested as an alternative site to measure blood pressures when the upper arm is unavailable .
BACKGROUND	However there is little evidence utilising clinical populations to support this substitution .
OBJECTIVE	To determine agreement between blood pressures measured in the left upper arm and forearm using a singular oscillometric non-invasive device in adult Emergency Department patients .
OBJECTIVE	The secondary objective was to explore the relationship of blood pressure differences with age , sex , ethnicity , smoking history and obesity .
METHODS	Single centre comparison study .
METHODS	Adult Emergency Department , Tertiary Trauma Centre .
METHODS	Forty-four participants who met inclusion/exclusion criteria selected sequentially from the Emergency Department arrival board .
METHODS	A random assignment of order of measurement for left upper arm and forearm blood pressures was utilised .
METHODS	Participants were eligible if they were aged 18 years or older , had been assigned an Australasian Triage Scale code of 2 , 3 , 4 , or 5 , were able to consent , and able to have blood pressures measured on their left arm whilst lying at a 45 angle .
METHODS	The Bland-Altman method of statistical analysis was used , with the level of agreement for clinical acceptability for the systolic , diastolic and mean arterial pressure defined as 10 mmHg .
RESULTS	The forearm measure overestimated systolic ( mean difference 2.2 mmHg , 95 % limits of agreement 19 mmHg ) , diastolic ( mean difference 3.4 mmHg , 95 % limits of agreement 14.4 mmHg ) , and mean arterial pressures ( mean difference 4.1 mmHg , 95 % limits of agreement 13.7 mmHg ) .
RESULTS	The systolic measure was not significantly different from zero .
RESULTS	Evidence of better agreement was found with upper arm/forearm systolic measures below 140 mmHg compared to systolic measures above 140 mmHg using the Levene 's test ( p = 0.002 , F-statistic = 11.09 ) .
RESULTS	Blood pressure disparity was not associated with participant characteristics .
CONCLUSIONS	Forearm measures can not routinely replace upper arm measures for blood pressure measurement .
CONCLUSIONS	If the clinical picture requires use of forearm blood pressure , the potential variance from an upper arm measure is 19 mmHg for systolic pressure , although the variability may be close to 10 mmHg if the systolic blood pressure is below 140 mmHg .

###24552980
OBJECTIVE	This study compared the effects of a 2-week program of low-volume high-intensity interval training ( HIT ) with the effects of higher-volume moderate-intensity continuous training ( CT ) on cardiopulmonary and vascular functions in postmenopausal women .
METHODS	Twenty-two postmenopausal women were randomly assigned to undertake six HIT ( n = 12 ) or CT ( n = 10 ) sessions for 2 weeks .
METHODS	HIT sessions consisted of ten 1-minute intervals of cycling exercise at 100 % of peak power output separated by 1 minute of active recovery .
METHODS	CT sessions involved 40 minutes of continuous cycling at 65 % of peak power output .
METHODS	Variables assessed at baseline and 2 weeks included cardiopulmonary function ( ventilatory threshold , peak oxygen uptake ) , macrovascular endothelial function ( flow-mediated dilation of the brachial artery ) , and microvascular function ( reactive hyperemia and local thermal hyperemia of forearm skin ) .
RESULTS	Eighteen participants completed the study ( HIT , 11 ; CT , 7 ) .
RESULTS	Adherence to the exercise programs was excellent , with 107 of 108 sessions completed .
RESULTS	Despite substantially lower total time commitment ( 2.5 vs. 5 h ) and training volume ( 558 vs. 1,237 kJ ) for HIT versus CT , increases from baseline in peak oxygen uptake achieved significance ( P = 0.01 ) for the HIT group only ( = 2.2 mL kg min ; P for interaction = 0.688 ) .
RESULTS	Improvements in exercise test duration were observed in both groups ( HIT , 13 % ; CT , 5 % ; P for interaction = 0.194 ) .
RESULTS	There were no significant changes in macrovascular or microvascular function in either group .
CONCLUSIONS	The findings suggest that low-volume HIT is feasible and can lead to rapid improvements in cardiopulmonary function in postmenopausal women .

###25462702
BACKGROUND	Breast cancer surgery with axillary lymphadenectomy may be associated with prolonged stay of the drain in the axilla due to high wound output , which may require further treatments and prolong the length of stay , impairing quality of life .
BACKGROUND	No definitive data are available concerning how to prevent this complication .
BACKGROUND	Our aim was to assess the efficacy of a new low-thrombin fibrin glue in reducing the serous output from the axillary surgical wound in patients undergoing axillary node dissection for breast cancer , and its long-term effects on lymphedema .
METHODS	Sixty patients undergoing surgery between September 2012 and June 2013 were enrolled .
METHODS	Thirty patients received Artiss ( Baxter , UK ) fibrin glue plus drainage , and 30 drainage alone .
METHODS	A multivariate analysis was performed to identify predictors of seroma , and subgroup analyses were performed .
METHODS	Lymphedema was assessed 12 months after surgery .
RESULTS	Patients who received fibrin glue had reduced serum output collected in the drain after surgery ( 94.3 22.4 vs 176 24.6 ml p < 0.001 ) and shorter length of postoperative hospital stay ( p = 0.001 ) .
RESULTS	Incidence of seroma at 4-week follow-up did not differ between groups .
RESULTS	At multivariate analysis , BMI 30 kg/m ( 2 ) was the only independent predictor of seroma formation ( OR = 2.7 , 95 % CI 1.4-5 .3 ; p = 0.002 ) .
RESULTS	Overweight patients receiving Artiss had fewer seroma at 4-week follow-up compared with control overweight patients ( 0 % vs 55.6 % , p = 0.03 ) .
RESULTS	No differences were observed in lymphedema between groups ( 6.7 % vs 10 % , p > 0.99 ) .
CONCLUSIONS	Low-thrombin fibrin glue reduced the amount of fluid produced in the axilla after breast surgery .
CONCLUSIONS	Overweight patients may be the ideal candidates for this treatment .
CONCLUSIONS	Such sealant did not increase the rates of lymphedema .

###25108611
BACKGROUND	Ecological intervention programs are recommended to prevent overweight and obesity in children .
BACKGROUND	The National Institute of Public Health ( INSP ) in Mexico implemented a successful ecological intervention program to promote healthy lifestyle behaviors in school age children .
BACKGROUND	This study assessed the integration of ecological principles and Social Cognitive Theory ( SCT ) constructs in this effective school-based obesity prevention program implemented in 15 elementary schools in Mexico City .
METHODS	Two coders applied the Intervention Analysis Procedure ( IAP ) to `` map '' the program 's integration of ecological principles .
METHODS	A checklist gauged the use of SCT theory in program activities .
RESULTS	Thirty-two distinct intervention strategies were implemented in one setting ( i.e. , school ) to engage four different target-groups ( students , parents , school representatives , government ) across two domains ( Nutrition and Physical Activity ) .
RESULTS	Overall , 47.5 % of the strategies targeted the school infrastructure and/or personnel ; 37.5 % of strategies targeted a key political actor , the Public Education Secretariat while fewer strategies targeted parents ( 12.5 % ) and children ( 3 % ) .
RESULTS	More strategies were implemented in the Nutrition domain ( 69 % ) than Physical Activity ( 31 % ) .
RESULTS	The most frequently used SCT construct within both intervention domains was Reciprocal Determinism ( e.g. , where changes to the environment influence changes in behavior and these behavioral changes influence further changes to the environment ) ; no significant differences were observed in the use of SCT constructs across domains .
CONCLUSIONS	Findings provide insight into a promising combination of strategies and theoretical constructs that can be used to implement a school-based obesity prevention program .
CONCLUSIONS	Strategies emphasized school-level infrastructure/personnel change and strong political engagement and were most commonly underpinned by Reciprocal Determinism for both Nutrition and Physical Activity .

###25708022
BACKGROUND	Intradialytic hypotension ( IDH ) is the most common complication of hemodialysis ( HD ) , and it plays a significant role in the morbidity and mortality associated with maintenance HD .
METHODS	This was a placebo-controlled , parallel-group study evaluating efficacy and safety of droxidopa in improving intradialytic blood pressure ( BP ) responses in 85 adults with end-stage renal disease ( ESRD ) and prone to IDH .
METHODS	Following screening and baseline periods , patients received 400 mg or 600 mg droxidopa , or placebo , orally 1 hour before HD for 4 weeks .
METHODS	Primary outcome endpoint was the change between baseline and last 2 treatment weeks in average mean arterial pressure ( MAP ) during HD .
METHODS	Also assessed were changes from baseline in systolic BP ( SBP ) and diastolic BP ( DBP ) during and after HD ; number of hypotension-induced interventions and symptoms ; and adverse events .
RESULTS	Increase in droxidopa intra-HD MAP were not significantly different from placebo , although droxidopa groups showed significant improvements in mean SBP after HD of +4.8 11.6 mm Hg ( 600-mg ) and +3.4 13.1 ( 400-mg ) compared with -4.4 17.9 mm Hg in placebo , and the drop seen in mean nadir SBP pre - to intra-HD was also reduced .
RESULTS	Changes in mean DBP pre - and post-HD , changes in mean nadir SBP post-HD , or intra-HD SBP were not significant over the treatment period .
RESULTS	HD terminations decreased 5-fold in the 600-mg group and 2-fold in the 400-mg group , whereas the number of discontinuations stayed unchanged in the placebo group .
RESULTS	Overall , treatment with 600-mg or 400-mg droxidopa was well tolerated in this population .
CONCLUSIONS	These data suggest that droxidopa may have a role in reducing IDH complications in patients with ESRD on chronic HD .

###24942540
OBJECTIVE	The efficacy and safety of subcutaneous tocilizumab ( TCZ-SC ) versus subcutaneous placebo ( PBO-SC ) was evaluated in patients with rheumatoid arthritis who had an inadequate response to disease-modifying antirheumatic drugs in the BREVACTA study .
METHODS	Patients ( n = 656 ) were randomized 2:1 to receive TCZ-SC 162 mg every other week or PBO-SC every other week for 24 weeks ; 20 % previously received anti-tumor necrosis factor treatment .
METHODS	Escape therapy with TCZ-SC 162 mg weekly was offered from week 12 for inadequate response .
METHODS	The primary end point was the American College of Rheumatology 20 % improvement ( ACR20 ) response at week 24 .
METHODS	The key secondary outcomes were radiographic progression and safety .
RESULTS	TCZ-SC was superior to PBO-SC for ACR20 response at week 24 ( 60.9 % versus 31.5 % ; P < 0.0001 ) .
RESULTS	All secondary end points showed TCZ-SC to be superior to PBO-SC , including ACR50 and ACR70 response ( 40 % and 20 % for TCZ-SC , respectively , and 12 % and 5 % for PBO-SC , respectively ; P < 0.0001 for both ) and Disease Activity Score in 28 joints ( DAS28 ) remission ( DAS28 < 2.6 ; 32 % versus 4 % [ P < 0.0001 ] ) .
RESULTS	The mean change in modified Sharp/van der Heijde score was significantly lower in the TCZ-SC group than the PBO-SC group ( 0.62 versus 1.23 ; P = 0.0149 ) .
RESULTS	Adverse events ( AEs ) and serious AEs ( SAEs ) were comparable between the TCZ-SC and PBO-SC groups ; 4.6 % and 3.7 % of patients had at least 1 SAE , respectively , and infection was the most common SAE in 2.1 % and 1.8 % of patients , respectively .
RESULTS	More injection site reactions occurred with TCZ-SC than PBO-SC ( 7.1 % versus 4.1 % ) .
RESULTS	No anaphylaxis or serious hypersensitivity reactions occurred .
RESULTS	There were 3 deaths in the TCZ-SC group and 0 in the PBO-SC group .
CONCLUSIONS	TCZ-SC every other week had significantly greater efficacy , including ACR end points and inhibition of joint damage , compared with PBO-SC .
CONCLUSIONS	TCZ-SC was well tolerated and its safety profile was comparable with that of previous intravenous TCZ studies .

###25438482
OBJECTIVE	Impaired nitric oxide synthesis has been implicated as one of the underlying causes of diabetic painful neuropathy ( DPN ) .
OBJECTIVE	Hence , effects of a cutaneous , nitric oxide releasing patch ( NitroSense Derma Protect ) were evaluated in subjects with DPN .
METHODS	Fifty diabetics were randomised to active/placebo arms after a 2 wk wash-out period .
METHODS	Patients received 24 mg patches ( each patch releases around 9 nmol/cm2/min of nitric oxide ) for 3 hrs , every other day during a 3 wks period , or indistinguishable placebo patches .
METHODS	The extent of pain was recorded at start , at each visit and following completion of the study .
METHODS	Changes in pain from baseline were measured using the 11 point lickert scale ( PLS ) , visual analogue scale ( VAS ) , short form mcgill , pain questionnaire ( SF-MPQ ) , present pain intensity ( PPI ) scale .
RESULTS	Subjects treated with patch experienced a statistically significant reduction in pain from baseline when compared to placebo ( PLS scale ; p = 0.05 ) .
RESULTS	Defining responders as subjects with a > 50 % reduction in PLS score from baseline , the number needed to treat ( NNT ) was calculated as 3.0 .
RESULTS	A significant post-treatment decrease ( p = 0.009 ) in vibration perception threshold ( VPT ) for left foot after active treatment was observed .
CONCLUSIONS	Present results highlight utility of NitroSense Derma Protect as controllable nitric oxide source for patients with DPN .

###25192777
BACKGROUND	Exercise-induced adaptations of the human atria remain understudied , particularly early in the training process .
BACKGROUND	We examined the effects of short-term high-intensity interval training ( HIT ) and continuous moderate-intensity training ( CMT ) on left atrial ( LA ) systolic and diastolic function , relative to left ventricular ( LV ) function in young , healthy men , by speckle tracking echocardiography ( STE ) .
METHODS	Fourteen untrained men ( mean age = 25 4 years ) were randomized to HIT or CMT , and assessed before and after six training sessions over a 12-day period .
METHODS	HIT included 8-12 intervals of cycling for 60 s at 95-100 % of maximal aerobic power ( VOMAX ) , interspersed by 75 s of cycling at 10 % VOMAX .
METHODS	CMT consisted of 90-120 min of cycling at 65 % VOMAX .
RESULTS	VOMAX increased following HIT and CMT by 11.5 and 5.5 % , respectively ( p < 0.05 ) .
RESULTS	Calculated plasma volume expanded 11 % following HIT and 10 % following CMT ( p < 0.005 ) .
RESULTS	Resting LV volumes and ejection fraction were unaltered following training .
RESULTS	Peak atrial longitudinal strain increased following HIT ( 41.8 5.2 % -47.1 3.7 % , p < 0.01 ) and CMT ( 38.5 4.6 % -41.7 6.0 % , p < 0.01 ) .
RESULTS	Atrial systolic strain rate increased following HIT ( 1.6 0.2 % / s-2 .0 0.3 % / s , p < 0.01 ) and CMT ( 1.6 0.2 % / s-1 .9 0.2 % / s , p < 0.01 ) .
CONCLUSIONS	LA function assessed by STE improves rapidly during short-term intensive exercise training .

###24272830
OBJECTIVE	To compare the effects of three methods of values clarification ( VCM ) : balance sheet ; rating and ranking ; and a discrete choice experiment ( DCE ) on decision-making about colorectal cancer ( CRC ) screening among adults in the US and Australia .
METHODS	Using online panels managed by a survey research organization in the US and Australia , we recruited adults ages 50-75 at average risk for CRC for an online survey .
METHODS	Those eligible were randomized to one of the three VCM tasks .
METHODS	CRC screening options were described in terms of five key attributes : reduction in risk of CRC incidence and mortality ; nature of the screening test ; screening frequency ; complications from screening ; and chance of requiring a colonoscopy ( as initial or follow-up testing ) .
METHODS	Main outcomes included self-reported most important attribute and unlabeled screening test preference by VCM and by country , assessed after the VCM .
RESULTS	A total of 920 participants were enrolled ; 51 % were Australian ; mean age was 59.0 ; 87.0 % were white ; 34.2 % had a 4-year college degree ; 42.8 % had household incomes less than $ 45,000 USD per year ; 44.9 % were up to date with CRC screening .
RESULTS	Most important attribute differed across VCM groups : the rating and ranking group was more likely to choose risk reduction as most important attribute ( 69.8 % ) than the balance sheet group ( 54.7 % ) or DCE ( 49.3 % ) , p < 0.0001 ; most important attribute did not vary by country ( p = 0.236 ) .
RESULTS	The fecal occult blood test ( FOBT ) - like test was the most frequently preferred test overall ( 55.9 % ) .
RESULTS	Unlabeled test choice did not differ meaningfully by VCM .
RESULTS	Australians were more likely to prefer the FOBT ( AU 66.2 % vs. US 45.1 % , OR 2.4 , 95 % CI 1.8 , 3.1 ) .
RESULTS	Few participants favored no screening ( US : 9.2 % , AU : 6.2 % ) .
CONCLUSIONS	Screening test attribute importance varied by VCM , but not by country .
CONCLUSIONS	FOBT was more commonly preferred by Australians than by Americans , but test preferences were heterogeneous in both countries .

###25460258
OBJECTIVE	Given the ubiquity of worrying as a consuming and distressing activity at both clinical and sub-clinical levels , it is important to develop theory-driven procedures that address worrying and allow worriers to manage this activity .
OBJECTIVE	This paper describes the development and testing of a psychoeducation procedure based on mood-as-input hypothesis , which is a transdiagnostic model that describes a proximal mechanism for perseverative worrying .
OBJECTIVE	The study used nonclinical participants meeting IAPT criteria indicating GAD symptomatology .
METHODS	In 4 sessions , participants in experimental groups received psychoeducation about the basic principles of the mood-as-input hypothesis and received guidance on how to identify and change worry-relevant goal-directed decision rules and negative moods .
METHODS	Participants in the psychoeducation conditions were compared with participants in a befriending control group .
RESULTS	Psychoeducation about the model significantly reduced PSWQ scores at follow-up compared with the befriending control condition ( a between-groups large effect size , Cohen 's d = 1.05 ) , and the homework tasks undertaken by the psychoeducation groups raised mood and reduced worry immediately .
RESULTS	At follow up 48.2 % of participants in the psychoeducation groups were below the recommended cut-off for identifying GAD symptomatology compared with 20 % of participants in the control condition .
CONCLUSIONS	This study was conducted on a small sample , high-worry student population , without a formal diagnosis .
CONCLUSIONS	This brief , low-intensity procedure is potentially adaptable to online or self-help procedures , and can be integrated into fuller cognitive therapy packages .

###24793366
OBJECTIVE	We evaluated the immunogenicity , efficacy , and safety of succinylnorcocaine conjugated to cholera toxin B protein as a vaccine for cocaine dependence .
METHODS	This 6-site , 24 week Phase III randomized double-blind placebo-controlled trial assessed efficacy during weeks 8 to 16 .
METHODS	We measured urine cocaine metabolites thrice weekly as the main outcome .
RESULTS	The 300 subjects ( 76 % male , 72 % African-American , mean age 46 years ) had smoked cocaine on average for 13 days monthly at baseline .
RESULTS	We hypothesized that retention might be better and positive urines lower for subjects with anti-cocaine IgG levels of 42 g/mL ( high IgG ) , which was attained by 67 % of the 130 vaccine subjects receiving five vaccinations .
RESULTS	Almost 3-times fewer high than low IgG subjects dropped out ( 7 % vs 20 % ) .
RESULTS	Although for the full 16 weeks cocaine positive urine rates showed no significant difference between the three groups ( placebo , high , low IgG ) , after week 8 , more vaccinated than placebo subjects attained abstinence for at least two weeks of the trial ( 24 % vs 18 % ) , and the high IgG group had the most cocaine-free urines for the last 2 weeks of treatment ( OR = 3.02 ) , but neither were significant .
RESULTS	Injection site reactions of induration and tenderness differed between placebo and active vaccine , and the 29 serious adverse events did not lead to treatment related withdrawals , or deaths .
CONCLUSIONS	The vaccine was safe , but it only partially replicated the efficacy found in the previous study based on retention and attaining abstinence .

###25087012
BACKGROUND	There is strong evidence of the efficacy of family psychosocial interventions for schizophrenia , but evidence of the role played by the attitudes of relatives in the therapeutic process is lacking .
METHODS	To study the effect of a family intervention on family attitudes and to analyse their mediating role in the therapeutic process 50 patients with schizophrenia and their key relatives undergoing a trial on the efficacy of a family psychosocial intervention were studied by means of the Affective Style Coding System , the Scale of Empathy , and the Relational Control Coding System .
METHODS	Specific statistical methods were used to determine the nature of the relationship of the relatives ' attitudes to the outcome of family intervention .
RESULTS	Family psychosocial intervention was associated with a reduction in relatives ' guilt induction and dominance and an improvement in empathy .
RESULTS	Empathy and lack of dominance were identified as independent mediators of the effect of family psychosocial intervention .
RESULTS	The change in empathy and dominance during the first 9months of the intervention predicted the outcome in the following 15months .
CONCLUSIONS	Relatives ' empathy and lack of dominance are mediators of the beneficial effect of family psychosocial intervention on patient 's outcome .

###24469611
OBJECTIVE	Cognitive-behavioral ( CB ) interventions improve outcomes for many pediatric health conditions , but little is known about which mechanisms mediate these outcomes .
OBJECTIVE	The goal of this study was to identify whether changes in targeted process variables from baseline to 1 week posttreatment mediate improvement in outcomes in a randomized controlled trial of a brief CB intervention for idiopathic childhood abdominal pain .
METHODS	Two hundred children with persistent functional abdominal pain and their parents were randomly assigned to 1 of 2 conditions : a 3-session social learning and CB treatment ( N = 100 ) , or a 3-session educational intervention controlling for time and attention ( N = 100 ) .
METHODS	Outcomes were assessed at 3 - , 6 - , and 12-month follow-ups .
METHODS	The intervention focused on altering parental responses to pain and on increasing adaptive cognitions and coping strategies related to pain in both parents and children .
RESULTS	Multiple mediation analyses were applied to examine the extent to which the effects of the social learning and CB treatment condition on child gastrointestinal ( GI ) symptom severity and pain as reported by children and their parents were mediated by changes in targeted cognitive process variables and parents ' solicitous responses to their child 's pain symptoms .
RESULTS	Reductions in parents ' perceived threat regarding their child 's pain mediated reductions in both parent-reported and child-reported GI symptom severity and pain .
RESULTS	Reductions in children 's catastrophic cognitions mediated reductions in child-reported GI symptom severity but no other outcomes .
RESULTS	Reductions in parental solicitousness did not mediate outcomes .
CONCLUSIONS	Results suggest that reductions in reports of children 's pain and GI symptoms after a social learning and CB intervention were mediated at least in part by decreasing maladaptive parent and child cognitions .

###25448024
OBJECTIVE	To assess the nasal functions , nasal resistance , and olfactory function in middle turbinate surgery .
METHODS	Randomized controlled trial .
METHODS	This prospective controlled study was carried out on patients who underwent laminectomy for aeration of the middle turbinate .
METHODS	Patients participating in the study were divided into two groups-group 1 : medial laminectomy ( n = 34 ) and group 2 : lateral laminectomy ( n = 38 ) .
METHODS	Patients underwent the preoperative visual analogue score , sinonasal outcome test-22 ( SNOT-22 ) , peak nasal inspiratory flowmeter , and Connecticut Chemosensory Clinical Research Center smell test .
METHODS	All patients were reevaluated 3 months after the operation .
RESULTS	The study group comprised 72 consecutive patients .
RESULTS	The mean age of the patients was 31.039.7 , with a range of 17 to 54 years .
RESULTS	A total of 47.2 % ( n = 34 ) had medial and 52.8 % ( n = 38 ) had lateral laminectomy .
RESULTS	Bilateral turbinate intervention was performed in 27.8 % ( n = 20 ) , whereas unilateral middle turbinate intervention was performed in 72.3 % ( n = 52 ) .
RESULTS	Overall , both groups showed strong significant improvement over time in visual analogue scale results , SNOT-22 scores , peak flowmeter results , and olfactory function between preoperative and postoperative scores ( P < 0.001 ) .
RESULTS	There was no significant difference between the groups for all parameters ( P > 0.05 ) .
CONCLUSIONS	This study revealed that medial laminectomy for aeration of the middle turbinate was as effective as lateral laminectomy .
METHODS	1b .
METHODS	Laryngoscope , 125:1062 -1066 , 2015 .

###24290737
BACKGROUND	Gabapentin enacarbil ( GEn ) is a prodrug of gabapentin and is approved in the United States in adults for the management of postherpetic neuralgia and in the United States and Japan for the treatment of moderate-to-severe primary restless legs syndrome .
OBJECTIVE	This study examined the lack of effect of GEn on cardiac repolarization in accordance with International Conference on Harmonisation E14 guidance .
METHODS	This was a randomized , double-blind , double-dummy , placebo - and active - controlled , crossover study in healthy adults ( age range , 18-50 years ) .
METHODS	Study participants received the following in randomized order with a minimum 7-day washout period between treatments : placebo at 0 hours and GEn 1200 mg at 2 hours ( GEn 1200 mg group ) , placebo at 0 hours and GEn 6000 mg at 2 hours ( GEn 6000 mg group ) , placebo at 0 and 2 hours ( placebo group ) , moxifloxacin 400 mg ( active control group ) at 0 hours , and placebo at 2 hours ( moxifloxacin group ) .
METHODS	Dose offsetting permitted moxifloxacin to be administered in the fasted state and GEn to be administered in the fed state .
METHODS	Assessments included continuous ECG monitoring , pharmacokinetic parameters , and safety and tolerability profiles .
METHODS	The primary end point was the change from baseline in the Fridericia corrected QT interval , at each time point , for the GEn 6000 mg and placebo groups .
RESULTS	Of 52 adults enrolled ( mean [ SD ] age , 30.8 [ 8.55 ] years ; 50 % women ) , 44 adults ( 85 % ) completed the study .
RESULTS	Forty-nine adults received GEn 1200 mg , 47 received GEn 6000 mg , 48 received placebo , and 47 received moxifloxacin .
RESULTS	The highest estimated ( upper limit of the 95 % CI ) model-adjusted difference in mean change from baseline in the Fridericia corrected QT interval between GEn and placebo was 3.55 ( 5.66 ) msec for 1200 mg and 1.20 ( 3.32 ) msec for 6000 mg .
RESULTS	Assay sensitivity was confirmed with moxifloxacin 400 mg .
RESULTS	The geometric mean ( % CV ) Cmax ( between-subject coefficient of variation ) was 7.49 ( 21.2 ) g/mL for GEn 1200 mg , 32.46 ( 23.9 ) g/mL for GEn 6000 mg , and 2.08 ( 24.5 ) g/mL for moxifloxacin 400 mg .
RESULTS	The most frequently reported adverse events with GEn 6000 mg were dizziness ( 30 % ) , feeling drunk ( 26 % ) , nausea ( 15 % ) , headache ( 13 % ) , and vomiting ( 13 % ) .
CONCLUSIONS	Single doses of GEn , up to 6000 mg , had no effect on cardiac repolarization in this thorough-QT study and are unlikely to cause clinically relevant QT prolongation in clinical use .
CONCLUSIONS	Assay sensitivity was confirmed with moxifloxacin as an active control .
CONCLUSIONS	ClinicalTrials.gov identifier : NCT01516372 .

###24755162
OBJECTIVE	Coronary vasodilator dysfunction has been reported after drug-eluting stent ( DES ) implantation .
OBJECTIVE	Recent ESC guidelines suggest that transthoracic echocardiography ( TTE ) may be considered for assessment of coronary flow reserve ( CFR ) and microvascular disease in patients with stable angina , but its reliability has not been tested in patients with DES .
OBJECTIVE	We sought to assess the agreement between TTE ( CFRTTE ) and invasive thermodilution-derived CFR ( CFRThermodilution ) as well as their association with index of microcirculatory resistance ( IMR ) in mid-term follow-up after percutaneous coronary intervention for acute coronary syndrome .
RESULTS	CFRTTE and CFRThermodilution were assessed 3 months after DES implantation in the left anterior descending artery in 24 patients .
RESULTS	Patients with haemodynamically significant epicardial stenosis ( fractional flow reserve < 0.75 ) were excluded .
RESULTS	Correlation between the two methods was good ( r = 0.71 , P < 0.001 ) , but CFRThermodilution ( mean SD ) tended to be higher ( 3.17 1.00 vs. 2.87 0.72 ; mean difference 0.29 , 95 % confidence interval -0.06 to 0.59 ) .
RESULTS	In Bland-Altman analysis , there was a trend towards a greater difference in the range of higher invasive values .
RESULTS	Nevertheless , TTE was successful in discriminating moderately impaired CFR ( 2.5 ) ( P = 0.001 ) and severely impaired CFR ( 2.0 ) ( P < 0.001 ) when compared with an invasive method .
RESULTS	No association between either CFR measurements vs. IMR measurement was detected , suggesting that in addition to microcirculatory function , CFR also accounts for epicardial vasodilator function in the absence of haemodynamically significant stenosis .
CONCLUSIONS	TTE is a feasible and reliable method for the assessment of CFR and vasodilator dysfunction after DES implantation .
CONCLUSIONS	Values obtained with this method successfully find abnormal CFR confirmed with the invasive thermodilution method .

###25496178
CONCLUSIONS	Daily intake of 480 mg of BNO 1016 for 15 days is an effective treatment in acute viral rhinosinusitis .
OBJECTIVE	The pooled efficacy data of two similar randomized placebo-controlled clinical trials were analyzed .
OBJECTIVE	Safety was evaluated on the basis of the individual trials .
METHODS	The efficacy analysis was based on 589 patients .
METHODS	Treatment was performed orally with either 3 160 mg BNO 1016 ( n = 294 ) or 3 placebo ( n = 295 ) for 15 days .
METHODS	In both trials patients underwent five visits to the investigational sites .
METHODS	Symptoms were evaluated according to the EPOS 2012 guideline .
METHODS	Ultrasonography was used to confirm the diagnosis at onset of treatment and the remission of symptoms at the last visit .
METHODS	Efficacy was evaluated by the investigator as the mean major symptom score ( MSS ) at the end of treatment ( visit 5 , day 14 ) .
METHODS	Patients reported symptoms and social/emotional consequences of rhinosinusitis using a quality of life questionnaire ( SNOT-20 GAV ) .
RESULTS	MSS improved during the treatment period by a mean of 10.02 1.61 score points to 2.47 2.55 for BNO 1016 and of 9.87 1.52 to 3.63 3.63 for placebo .
RESULTS	Differences between treatment groups at end of therapy ( 1.16 3.14 score points ; p < 0.0001 ) and patient-assessed quality of life ( p = 0.0015 ) were statistically significant in favor of BNO 1016 .

###25038542
BACKGROUND	Rectal cancer continues to be devastating malignancy worldwide .
BACKGROUND	Sphincter preservation is the need of the hour .
BACKGROUND	Distal anastomosis is more prone to leaks .
BACKGROUND	Proximal diversion in form of ileostomy may be used to protect distal anastomosis .
OBJECTIVE	To compare two groups of low anterior resection with and without diversion ileostomy in rectal cancer patients .
METHODS	A prospective , hospital based study of 78 rectal carcinoma patients were taken for the study .
METHODS	Inclusion criteria was operable rectal cancer 4-12 cm from anal verge .
METHODS	Patients were randomized into two groups .
METHODS	Group - A ( 34 patient ) patients with low anterior resection with ileostomy ( LAR with ileostomy ) ; Group - B ( 44 patients ) patients with low anterior resection without ileostomy ( LAR without ileostomy ) .
METHODS	Quality of life was assessed by scoring done by self designed method .
METHODS	A total score of 0-20 given for various parameters .
RESULTS	Skin excoriation was the commonest complication .
RESULTS	Stomal retraction and stomal obstruction was seen in 1 patient each ( 3 % ) .
RESULTS	Hypokalemia was the commonest electrolyte imbalance present in ileostomy group .
RESULTS	Anastomotic leak was present in 6 % of Group A and 11 % of Group B patients .
RESULTS	Mean time of closure of ileostomy was 16 4.3 weeks .
CONCLUSIONS	LAR with ileostomy has certain advantages over LAR without ileostomy in terms of anastomotic leak , postoperative ileus , resumption of diet , wound infection , small bowel obstruction and in terms mortality and recurrence .
CONCLUSIONS	However stoma related complications were main disadvantage in LAR with ileostomy .

###24679046
BACKGROUND	Currently few evidence based interventions are available for the prevention of PTSD within the first weeks after trauma .
BACKGROUND	Increased risk for PTSD development is associated with dysregulated fear and stress responses prior to and shortly after trauma , as well as with a lack of perceived social support early after trauma .
BACKGROUND	Oxytocin is a potent regulator of these processes .
BACKGROUND	Therefore , we propose that oxytocin may be important in reducing adverse consequences of trauma .
BACKGROUND	The ` BONDS ' study is conducted in order to assess the efficacy of an early intervention with intranasal oxytocin for the prevention of PTSD .
METHODS	In this multicenter double-blind randomized placebo-controlled trial we will recruit 220 Emergency Department patients at increased risk of PTSD .
METHODS	Trauma-exposed patients are screened for increased PTSD risk with questionnaires assessing peri-traumatic distress and acute PTSD symptoms within 7 days after trauma .
METHODS	Baseline PTSD symptom severity scores and neuroendocrine and psychophysiological measures will be collected within 10 days after trauma .
METHODS	Participants will be randomized to 7.5 days of intranasal oxytocin ( 40 IU ) or placebo twice a day .
METHODS	Follow-up measurements at 1.5 , 3 and 6 months post-trauma are collected to assess PTSD symptom severity ( the primary outcome measure ) .
METHODS	Other measures of symptoms of psychopathology , and neuroendocrine and psychophysiological disorders are secondary outcome measures .
CONCLUSIONS	We hypothesize that intranasal oxytocin administered early after trauma is an effective pharmacological strategy to prevent PTSD in individuals at increased risk , which is both safe and easily applicable .
CONCLUSIONS	Interindividual and contextual factors that may influence the effects of oxytocin treatment will be considered in the analysis of the results .
BACKGROUND	Netherlands Trial Registry : NTR3190 .

###25457173
OBJECTIVE	To evaluate whether the transillumination method increased the probability of appropriate tracheal tube ( TT ) placement compared with the main-stem method .
METHODS	Prospective , randomized , controlled study .
METHODS	Operating room , university hospital .
METHODS	Eighty children < 2 years old scheduled for elective surgery undergoing general anesthesia .
METHODS	Trachlight was used for the transillumination method .
METHODS	After intubation , patients were randomly assigned to 1 of 2 groups : ( 1 ) deliberate bronchial intubation with subsequent withdrawal of the TT to 2 cm above the carina ( main-stem group ) or ( 2 ) transmitted visual signal from a bright light at the TT tip on the skin at the suprasternal notch after inserting the Trachlight into the TT ( transillumination group ) .
METHODS	The TT tip position was assessed by chest radiograph after the procedure .
METHODS	Appropriate TT placement was defined when the TT tip was located between the sternoclavicular junction and 1 cm above the carina .
RESULTS	Appropriate TT placement was found in 31 ( 80 % ) of 39 patients in the transillumination group and 26 ( 65 % ) of 40 in the main-stem group .
RESULTS	The transillumination method had higher rate of appropriate TT placement than the main-stem method ( P = .15 ; risk ratio , 1.22 ; 95 % confidence interval , 0.93-1 .61 ) .
RESULTS	Seven patients ( 18 % ) had proximal TT placement , and 1 ( 3 % ) had distal TT placement in the transillumination group .
RESULTS	In the main-stem group , 7 patients ( 18 % ) had proximal TT placement , and 7 ( 18 % ) had distal TT placement .
CONCLUSIONS	The transillumination method was reliable for appropriate TT placement in small children < 2 years old undergoing general anesthesia , although the transillumination method was not found to be better compared with the main-stem method .

###25280761
OBJECTIVE	Myocardial blood flow ( MBF ) quantification with dynamic SPECT could lead to widespread utilization of MBF imaging in clinical practice with little cost increase over current standard SPECT myocardial perfusion imaging .
OBJECTIVE	This work evaluates the feasibility and operator-dependent variability of MBF and flow reserve measurements with ( 99m ) Tc-sestamibi ( MIBI ) dynamic SPECT imaging using a standard dual-head SPECT camera .
METHODS	Twenty-eight patients underwent dipyridamole-stress and rest imaging with dynamic SPECT/CT acquisition .
METHODS	Quantitative images were iteratively reconstructed with all physical corrections and then myocardial and arterial blood regions of interest ( ROI ) were defined semi-automatically .
METHODS	A compartmental model was fitted to these ROI-sampled time-activity-curves , and flow-dependent MIBI extraction correction was applied to derive regional MBF values .
METHODS	Myocardial flow reserve ( MFR ) was estimated as stress/rest MBF ratio .
METHODS	MBF and MFR in low and high risk populations were evaluated for ability to detect disease .
METHODS	Images were each processed twice ( 7 days apart ) by one expert and one novice operator to evaluate intra - and inter-operator variability of MBF and MFR measurement in the three coronary artery vascular territories .
RESULTS	Mean rest flow , stress flow , and MFR values were 0.83 , 1.82 mLminute ( -1 ) g ( -1 ) , and 2.45 , respectively .
RESULTS	For stress/rest MFR , the inter-operator reproducibility was r ( 2 ) = 0.86 with RPC = 1.1 .
RESULTS	Stress MBF and MFR were significantly reduced ( P < .05 ) in high risk ( n = 9 ) vs low risk populations ( n = 19 ) , indicating ability to detect disease .
RESULTS	For expert and novice operators very good intra-operator correlations of r ( 2 ) = 0.98 and 0.95 ( n = 168 , P < .001 ) were observed for combined rest and stress regional flow values .
RESULTS	Bland-Altman reproducibility coefficients ( RPC ) were 0.25 and 0.47 mLminute ( -1 ) g ( -1 ) for the expert and novice operators , respectively ( P < .001 ) .
RESULTS	Inter-operator correlation was r ( 2 ) = 0.91 and Bland-Altman RPC = 0.58 mLminute ( -1 ) g ( -1 ) ( n = 336 ) .
CONCLUSIONS	MBF and reserve measurements using ( 99m ) Tc-sestamibi on a traditional , two-headed camera with fast rotation and with quantitative dynamic SPECT appears to be feasible , warranting further investigation .

###25062593
OBJECTIVE	Cognitive impairment is an enduring and functionally relevant feature of early-onset schizophrenia ( EOS ) .
OBJECTIVE	Cognitive remediation therapy ( CRT ) improves cognition and functional outcome in adults with schizophrenia , although data in adolescents with EOS remain scarce .
OBJECTIVE	The purpose of this study is to examine the efficacy of CRT in improving cognition and functional outcomes in a sample of symptomatically stable but cognitively disabled adolescents with EOS .
METHODS	We performed a randomized , controlled trial of individually delivered CRT plus treatment-as-usual compared with treatment-as-usual ( TAU ) .
METHODS	Fifty adolescents with EOS were randomly assigned to receive CRT ( n = 25 ) or TAU ( n = 25 ) and were included in an intention-to-treat analysis .
METHODS	Clinical symptoms and cognitive and functional performance were assessed before and after treatment in both groups and after 3 months in the CRT group .
METHODS	Cognitive domains were defined according to the Measurement and Treatment Research to Improve Cognition in Schizophrenia ( MATRICS ) consensus battery and averaged in a global cognitive composite score .
RESULTS	After CRT , significant improvements were found in verbal memory and executive functions , with medium-to-large effect sizes ( ES ) .
RESULTS	The derived cognitive composite score showed an improvement after the treatment , with a large ES .
RESULTS	This change was reliable in more than two-thirds of the treated patients .
RESULTS	Medium-sized ES were found for improvements after CRT in daily living and adaptive functioning , whereas large ES were observed for improvements in family burden .
RESULTS	With the exception of functional gains , these changes were maintained after 3 months .
CONCLUSIONS	CRT appears to be a useful intervention strategy for adolescents with EOS .
CONCLUSIONS	Cognitive improvements can be achieved through CRT , although further research is warranted to determine the durability of functional gains .
CONCLUSIONS	Clinical trial registration information-Cognitive Remediation Therapy ( CRT ) in Adolescents With EOS ; www.clinicaltrials.gov ; NCT01701609 .

###25822674
BACKGROUND	Sentinel lymph node biopsy ( SLNB ) has become the gold standard for axillary staging .
BACKGROUND	Debate remains as to the optimal method of SLN detection .
OBJECTIVE	Determine whether patients undergoing an SLNB required the addition of isosulfan blue dye to radioisotope when an SLN was identified on a preoperative lymphoscintigram .
METHODS	A prospective randomized controlled trial comparing the combination of radioisotope and blue dye versus radioisotope alone was performed between March 2010 and September 2012 .
METHODS	The trial protocol was registered with Current Controlled Trials .
METHODS	Women with clinically and radiologically node-negative breast cancer with a positive preoperative lymphoscintigram were eligible for inclusion .
RESULTS	A total of 667 patients were included in the analysis with 342 patients receiving the combination ( blue dye and radioisotope ) and 325 patients receiving radioisotope alone .
RESULTS	The groups were evenly matched both demographically and pathologically .
RESULTS	The mean age was 48 years ( 48.3 vs 47.7 years ; P = 0.47 ) , the mean tumour size was 24.2 mm ( 24.3 mm vs 24.1 mm ; P = 0.7 ) and there was no statistically significant difference in the grade of the tumors between the 2 groups ( P = 0.58 ) .
RESULTS	There was no difference in the identification rate , nor was that in the number of nodes retrieved between the 2 groups ( P = 0.30 ) .
RESULTS	There was no difference in the number of positive lymph nodes that were identified between the 2 groups ( 23.8 % vs 22.1 % ; P = 0.64 ) .
CONCLUSIONS	This study failed to demonstrate an advantage with the addition of isosulfan blue dye to radioisotope in the identification of the SLN in the presence of a positive preoperative lymphoscintigram .

###25085539
BACKGROUND	Substance misuse in those with severe mental health problems is common and associated with poor engagement in treatment and treatment outcomes .
BACKGROUND	Up to 44 % of those admitted into psychiatric inpatient facilities have coexisting substance-misuse problems .
BACKGROUND	However , this is not routinely addressed as part of their treatment plan .
BACKGROUND	A mental health admission may present a window of opportunity for inpatients to reevaluate the impact of their substance use .
BACKGROUND	This study will aim to evaluate the effectiveness of a targeted brief motivational intervention in improving engagement in treatment and to assess how feasible and acceptable this intervention is to inpatients and staff as a routine intervention .
METHODS	This randomized controlled trial will use concealed randomization ; blind , independent assessment of outcome at 3 months ; characterization of refusers and dropouts ; and be analyzed according to the intention-to-treat principle .
METHODS	After baseline assessments , eligible participants will be randomized either to the Brief Integrated Motivational Intervention plus Treatment As Usual , or Treatment as Usual alone .
METHODS	Eligible participants will be those who are new admissions ; > 18 years ; ICD-10 diagnosis of - schizophrenia or related disorder , bipolar affective disorder , recurrent depressive disorder , and DSM-IV diagnosis of substance abuse or dependence over the last 3 months .
METHODS	The primary outcome is engagement in treatment for substance misuse , and secondary outcomes include readiness to change substance misuse together with a cost-effectiveness analysis .
METHODS	Qualitative interviews with staff and participants will assess the acceptability of the intervention .
CONCLUSIONS	This pilot randomized trial will provide the first robust evidence base for inpatient care of people with severe mental health problems and co-morbid substance misuse and provide the groundwork for confirmatory trials to evaluate a potentially feasible , cost-effective , and easy-to-implement treatment option that may be readily integrated into standard inpatient and community-based care .
BACKGROUND	ISRCTN43548483 Date of ISRCTN assignation : 4/17/2014 .

###24743431
OBJECTIVE	To assess whether adding a fibrate to statin therapy reduces residual cardiovascular risk associated with elevated triglycerides and low high-density lipoprotein cholesterol , The Evaluation of Choline Fenofibrate ( ABT-335 ) on Carotid Intima-Media Thickness ( cIMT ) in Subjects with Type IIb Dyslipidemia with Residual Risk in Addition to Atorvastatin Therapy ( FIRST ) trial evaluated the effects of fenofibric acid ( FA ) treatment on cIMT in patients with mixed dyslipidemia on atorvastatin .
RESULTS	This multicenter , double-blind , placebo-controlled study was performed in patients with mixed dyslipidemia ( fasting triglycerides , 150 mg/dL ; high-density lipoprotein cholesterol , 45 [ men ] or 55 mg/dL [ women ] ; low-density lipoprotein cholesterol , 100 mg/dL once and averaging 105 mg/dL ) and a history of coronary heart disease or risk equivalent .
RESULTS	Patients on background atorvastatin ( continued on starting dose or titrated to 40 mg , if needed ) were randomized to FA 135 mg or placebo .
RESULTS	The primary end point was rate of change from baseline through week 104 of the mean posterior-wall cIMT , measured by ultrasound .
RESULTS	In patients with controlled low-density lipoprotein cholesterol while on atorvastatin background therapy , rate of change in posterior-wall cIMT was similar with FA plus atorvastatin ( -0.006 mm/y ) versus atorvastatin monotherapy ( 0.000 mm/y ; P = 0.22 ) .
RESULTS	FA plus atorvastatin was favored ( P < 0.05 ) in 5 of 24 prespecified subgroups : age 60 years , history of coronary artery disease , cIMT > 0.795 mm , triglycerides 170 to 235 mg/dL , and statin use at entry .
RESULTS	Adverse events were consistent with the known safety profiles of both drugs ; however , FA plus atorvastatin was associated with a greater incidence of renal-related adverse events compared with atorvastatin monotherapy ( 6.5 % versus 0.9 % ) .
CONCLUSIONS	Compared with atorvastatin monotherapy , FA plus atorvastatin did not further decrease cIMT progression in high-risk patients with mixed dyslipidemia .

###25302575
BACKGROUND	The role of glycemic index ( GI ) and foods with negative attributes related to GI as part of a weight loss regimen has not been thoroughly assessed in free-living individuals .
BACKGROUND	This study examined the effects of a dietary prescription for energy intake modification , GI , and potato consumption on weight loss , dietary prescription adherence , body composition , and glucose control in a free-living , self-selecting overweight population .
METHODS	Ninety overweight ( body mass index [ BMI ] 29.6 3.9 ) men and women were randomly assigned to one of 3 groups for 12 weeks .
METHODS	Two groups were counseled to reduce their energy intake by 500 kcal/day and consume diets that were predominantly composed of either low - or high-GI foods ( low glycemic index energy reduced [ LGI-ER ] or high glycemic index energy reduced [ HGI-ER ] diet , respectively ) .
METHODS	The third group received no energy restriction , GI provision , or nutritional counseling .
METHODS	All groups were instructed to consume 5-7 servings of potatoes per week .
METHODS	Changes in weight , body composition , glucose tolerance , and triglycerides were determined at baseline and 12 weeks .
RESULTS	There were no significant differences in weight loss or changes in body composition between the groups ; however , modest weight loss and body composition changes were seen from week 0 to week 12 for all groups ( p < 0.05 ) .
RESULTS	Difficulty achieving the prescribed GI diets was evident in this free-living setting .
RESULTS	There were no significant changes within or among treatments for fasting concentrations of triglycerides , glucose tolerance , insulin , or insulin sensitivity .
CONCLUSIONS	The results indicate that in a free-living population of men and women , weight loss is associated with energy intake reduction .
CONCLUSIONS	Potato intake did not cause weight gain and following either a high - or low-GI dietary prescription was difficult for free-living subjects , emphasizing the complex nature of changing dietary patterns .

###24682079
OBJECTIVE	This prospective , randomized , single-blinded study evaluates the effectiveness of the ultrasound-guided bilateral thoracic paravertebral ( BTPV ) block for providing postoperative pain control in children undergoing the Nuss procedure .
METHODS	Thirty American Society of Anesthesiologists I-II children with pectus excavatum , scheduled for the Nuss procedure , were enrolled at West China Hospital of Sichuan University .
METHODS	The patients were randomly allocated into the BTPV block group or the control group .
METHODS	In the BTPV group , 0.25 % ropivacaine 0.5 mL/kg with 1:200,000 epinephrine was injected under ultrasound guidance on each side at the level of the fifth thoracic vertebra .
METHODS	Postoperative pain was evaluated in both groups for the first 48 hours .
METHODS	Total opioid administered and cumulative attempts on the patient/parent-controlled intravenous analgesia ( PCA ) pump were recorded .
METHODS	Postoperative negative behavioral changes in the children were evaluated on postoperative days 1 , 7 , and 30 , respectively , using the posthospital behavior questionnaire .
RESULTS	The pain scores were significantly reduced in the postanesthesia care unit and for the first 48 hours postoperatively in the BTPV group compared to the control group ( P < 0.01 ) .
RESULTS	The sufentanil use in the postanesthesia care unit was significantly greater in the control group [ mean ( SD ) , 0.2 ( 0 ) mcg/kg ] compared to the BTPV group [ mean ( SD ) , 0.05 ( 0.06 ) mcg/kg ] ( P < 0.01 ) .
RESULTS	The postoperative sufentanil use was significantly higher in the control group during the first 24 hours ( P < 0.01 ) .
RESULTS	Numbers of attempts on the PCA pump were significantly greater in the control group ( P < 0.01 ) .
RESULTS	The posthospital behavior questionnaire score was lower in the BTPV group on day 1 , day 7 , and 1 month , respectively ( P < 0.01 ) .
CONCLUSIONS	Ultrasound-guided BTPV block provides improved postoperative analgesia for children undergoing the Nuss procedure as compared with intravenous PCA and decreases the incidence of postoperative behavioral disturbance .

###25956209
BACKGROUND	Tumour shrinkage ( TS ) increases the possibility of resection in metastatic colorectal cancer ( mCRC ) and may improve tumour-related symptoms .
BACKGROUND	Here we report prespecified secondary response-related end-points and exploratory TS/resection outcomes for patients with RAS wild-type ( WT ) tumours ( no mutations in KRAS/NRAS exons 2/3/4 ) from the PRIME study ( NCT00364013 ) .
METHODS	PRIME was a randomised phase 3 study comparing first-line panitumumab + FOLFOX4 versus FOLFOX4 in mCRC patients .
METHODS	Tumour response analyses were conducted to compare response rates and their impact on survival outcomes .
RESULTS	Overall , 505 patients had RAS WT mCRC .
RESULTS	More patients receiving panitumumab + FOLFOX4 versus FOLFOX4 had 30 % ( 59 % versus 38 % ; P < 0.001 ) or 20 % ( 72 % versus 57 % ; P < 0.001 ) TS at week 8 ( early TS ) ; consistent TS benefits were observed over the first 40weeks of treatment .
RESULTS	Objective response rate ( P = 0.003 ) , duration of response ( P = 0.0027 ) , depth of response ( P = 0.0149 ) , progression-free survival ( PFS ; P = 0.0015 ) and overall survival ( OS ; P = 0.0057 ) were improved in the panitumumab + FOLFOX4 group .
RESULTS	Both early TS and resection were associated with improved PFS and OS .
RESULTS	2-year OS rates for patients who did ( n = 64 ) versus did not ( n = 441 ) undergo resection were 88 % versus 40 % ; 2-year OS rates for patients who did ( n = 45 ) versus did not ( n = 460 ) undergo complete resection were 96 % versus 41 % .
CONCLUSIONS	More patients receiving panitumumab + FOLFOX4 versus FOLFOX4 had 30 % or 20 % TS at week 8 ; PFS and OS were also improved with panitumumab + FOLFOX4 .
CONCLUSIONS	The clinical value of achieving early TS in mCRC warrants further investigation .

###24725442
OBJECTIVE	This was a randomized , placebo-controlled , double-blind , sequential , ascending-dose study to assess the safety , tolerability , pharmacokinetics , and pharmacodynamics of multiple oral doses of apixaban in healthy Japanese male subjects .
METHODS	The study was conducted using three sequential dose panels : apixaban 2.5 mg , 5 mg , and 10 mg given twice daily .
METHODS	For each dose panel , subjects were randomly assigned to receive oral apixaban ( n = 6 ) or matching placebo ( n = 2 ) for 7 days .
METHODS	The pharmacokinetics of apixaban and effect on pharmacodynamic variables ( clotting assays and anti-Xa activity ) were assessed on day 1 and day 7 of treatment .
METHODS	Safety was assessed throughout the study .
METHODS	Only after the preceding dose was confirmed to be safe and well-tolerated subjects were enrolled into the next-higher-dose panel .
RESULTS	Apixaban was safe and well-tolerated in these healthy Japanese male subjects across the doses evaluated .
RESULTS	On day 7 , peak plasma concentrations were reached ~ 3 hours postdose , and increases in peak plasma concentration ( C ( max ) ) , trough plasma concentration , and area under the plasma concentration-time curve across one dosing interval ( 12 hours ) were tested dose-proportional across the dose range .
RESULTS	A modest degree of accumulation was observed that was similar for all doses ( accumulation index of 1.7 to 2.0 ) , and renal clearance was consistent across doses ( 0.91 L/h - 1.07 L/h ) .
RESULTS	Exposure-dependent prolongation of prothrombin time , activated partial thromboplastin time , modified prothrombin time , and increases in anti-Xa activity were observed after single and multiple doses of apixaban .
CONCLUSIONS	Apixaban was safe and well-tolerated in healthy Japanese subjects .
CONCLUSIONS	The pharmacokinetic profile of apixaban following multiple twice-daily doses was linear , and exposure parameters such as C ( max ) , observed at ~ 3 hours post-dose , and area under the plasma concentration-time curve increased in a dose-proportional manner .
CONCLUSIONS	Pharmacodynamic profiles closely followed the apixaban plasma concentration-time profiles .

###25069975
BACKGROUND	An intervention was designed to introduce rapid diagnostics tests for malaria ( mRDTs ) into registered drug shops in Uganda to encourage rational and appropriate treatment of malaria with artemisinin-based combination therapy ( ACT ) .
BACKGROUND	We conducted participatory training of drug shop vendors and implemented supporting interventions to orientate local communities ( patients ) and the public sector ( health facility staff and district officials ) to the behavioral changes in diagnosis , treatment and referral being introduced in drug shops .
BACKGROUND	The intervention was designed to be evaluated through a cluster randomized trial .
BACKGROUND	In this paper , we present detailed design , implementation and evaluation experiences in order to help inform future studies of a complex nature .
METHODS	Three preparatory studies ( formative , baseline and willingness-to-pay ) were conducted to explore perceptions on diagnosis and treatment of malaria at drug shops , and affordable prices for mRDTs and ACTs in order to inform the design of the intervention and implementation modalities .
METHODS	The intervention required careful design with the intention to be acceptable , sustainable and effective .
METHODS	Critical components of intervention were : community sensitization and creating awareness , training of drug shop vendors to diagnose malaria with mRDTs , treat and refer customers to formal health facilities , giving pre-referral rectal artesunate and improved record-keeping .
METHODS	The primary outcome was the proportion of patients receiving appropriately-targeted treatment with ACT , evaluated against microscopy on a research blood slide .
RESULTS	Introducing mRDTs in drug shops may seem simple , but our experience of intervention design , conduct and evaluation showed this to be a complex process requiring multiple interventions and evaluation components drawing from a combination of epidemiological , social science and health economics methodologies .
RESULTS	The trial was conducted in phases sequenced such that each benefited from the other .
CONCLUSIONS	The main challenges in designing this trial were maintaining a balance between a robust intervention to support effective behaviour change and introducing practices that would be sustainable in a real-life situation in tropical Africa ; as well as achieving a detailed evaluation without inadvertently influencing prescribing behaviour .
BACKGROUND	NCT01194557 registered with ClinicalTrials.gov 2 September 2010 .

###26055855
OBJECTIVE	To identify risk factors for recurrent urinary tract infection ( UTI ) and renal scarring in children who have had 1 or 2 febrile or symptomatic UTIs and received no antimicrobial prophylaxis .
METHODS	This 2-year , multisite prospective cohort study included 305 children aged 2 to 71 months with vesicoureteral reflux ( VUR ) receiving placebo in the RIVUR ( Randomized Intervention for Vesicoureteral Reflux ) study and 195 children with no VUR observed in the CUTIE ( Careful Urinary Tract Infection Evaluation ) study .
METHODS	Primary exposure was presence of VUR ; secondary exposures included bladder and bowel dysfunction ( BBD ) , age , and race .
METHODS	Outcomes were recurrent febrile or symptomatic urinary tract infection ( F/SUTI ) and renal scarring .
RESULTS	Children with VUR had higher 2-year rates of recurrent F/SUTI ( Kaplan-Meier estimate 25.4 % compared with 17.3 % for VUR and no VUR , respectively ) .
RESULTS	Other factors associated with recurrent F/SUTI included presence of BBD at baseline ( adjusted hazard ratio : 2.07 [ 95 % confidence interval ( CI ) : 1.09-3 .93 ] ) and presence of renal scarring on the baseline ( 99m ) Tc-labeled dimercaptosuccinic acid scan ( adjusted hazard ratio : 2.88 [ 95 % CI : 1.22-6 .80 ] ) .
RESULTS	Children with BBD and any degree of VUR had the highest risk of recurrent F/SUTI ( 56 % ) .
RESULTS	At the end of the 2-year follow-up period , 8 ( 5.6 % ) children in the no VUR group and 24 ( 10.2 % ) in the VUR group had renal scars , but the difference was not statistically significant ( adjusted odds ratio : 2.05 [ 95 % CI : 0.86-4 .87 ] ) .
CONCLUSIONS	VUR and BBD are risk factors for recurrent UTI , especially when they appear in combination .
CONCLUSIONS	Strategies for preventing recurrent UTI include antimicrobial prophylaxis and treatment of BBD .

###24833648
BACKGROUND	Exercise intolerance is a hallmark of heart failure , but factors associated with impaired exercise capacity in heart failure with preserved ejection fraction are unclear .
BACKGROUND	We hypothesized that in heart failure with preserved ejection fraction , the severity of resting ventricular and vascular dysfunction are associated with impairment in exercise tolerance as assessed by peak oxygen consumption .
RESULTS	Subjects with heart failure with preserved ejection fraction enrolled in the PhosphodiesteRasE-5 Inhibition to Improve CLinical Status And EXercise Capacity in Diastolic Heart Failure ( RELAX ) clinical trial ( n = 216 ) underwent baseline Doppler echocardiography , cardiopulmonary exercise testing , and cardiac MRI .
RESULTS	RELAX participants were elderly ( median age 69 years ) and 48 % were women .
RESULTS	Ejection fraction ( 60 % ) and stroke volume ( 77 mL ) were normal , while diastolic dysfunction ( medial E/e ' , 16 ; deceleration time , 185 ms ; left atrial volume , 44 mL/m ( 2 ) ) and increased arterial load ( arterial elastance , 1.51 mm Hg/mL ) were evident .
RESULTS	Peak oxygen consumption was reduced ( 11.7 mLkg ( -1 ) min ( -1 ) , 1141 mL/min ) and age , sex , body mass index , hemoglobin , and chronotropic response collectively explained 64 % of the variance in raw peak oxygen consumption ( mL/min ) .
RESULTS	After adjustment for these variables , left ventricular structure ( diastolic dimension [ 1.5 % , P = 0.008 ] and left ventricular mass [ 1.6 % , P = 0.008 ] ) , resting stroke volume ( 2.0 % , P = 0.002 ) , left ventricular diastolic dysfunction ( deceleration time [ 0.9 % , P = 0.03 ] and E/e ' [ 1.4 % , P = 0.009 ] ) , and arterial function ( arterial elastance [ 2.1 % , P = 0.002 ] and systemic arterial compliance [ 1.5 % , P = 0.007 ] ) , each explained only a small additional portion of the variance in peak oxygen consumption .
CONCLUSIONS	In heart failure with preserved ejection fraction , potentially modifiable factors ( obesity , anemia , and chronotropic incompetence ) are strongly associated with exercise capacity , whereas resting measures of ventricular and vascular structure and function are not .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00763867 .

###24585406
BACKGROUND	Epidermal growth factor receptor tyrosine kinase inhibitors ( EGFR-TKIs ) show great efficacy in patients with advanced non-small cell lung cancer ( NSCLC ) with EGFR mutations .
BACKGROUND	The efficacy and safety of gefitinib following adjuvant chemotherapy in patients with EGFR mutation are unknown .
METHODS	In this open-label , phase II study , patients with resected stage IIIA-N2 NSCLC harbouring EGFR mutations ( either exon 19 deletion or L858R point mutation ) were assigned randomly to receive pemetrexed ( 500mg/m ( 2 ) ) and carboplatin ( AUC = 5 ) , administered every 21days for 4 cycles , followed with or without gefitinib ( 250mg/day ) for 6months .
METHODS	The primary end point was disease-free survival ( DFS ) .
RESULTS	From August 2008 to September 2011 , 60 patients were included in our center .
RESULTS	DFS was significantly longer among those who received pemetrexed and carboplatin ( PC ) - gefitinib than among those who received PC alone [ hazard ratio ( HR ) , 0.37 ; 95 % confidence interval ( CI ) 0.16-0 .85 ; P = 0.014 ; median , 39.8 vs. 27.0 months ] .
RESULTS	The rates of 2-year DFS were 78.9 % in the PC-gefitinib group and 54.2 % in the PC alone group .
RESULTS	The rates of 2-year overall survival ( OS ) were 92.4 % in the PC-gefitinib group and 77.4 % in the PC alone group ( HR , 0.37 ; 95 % CI 0.12-1 .11 , P = 0.076 ) .
RESULTS	The most common adverse event was rash ( 43.3 % , 13/30 ) in the PC-gefitinib group and the administration of gefitinib following chemotherapy was well tolerated .
CONCLUSIONS	The administration of gefitinib following PC adjuvant therapy shows significant improvement in DFS in patients with resected stage IIIA-N2 NSCLC harbouring EGFR mutations .

###24390146
BACKGROUND	Inflammation is fundamental to the development of atherosclerosis .
BACKGROUND	We examined the effect of anti-inflammatory doses of salicylate on endothelium-dependent vasodilation , a biomarker of cardiovascular risk , in a broad range of subjects .
RESULTS	We performed a randomized , double-blind , placebo-controlled crossover trial evaluating the effects of 4 weeks of high-dose salsalate ( disalicylate ) therapy on endothelium-dependent flow-mediated and endothelium-independent vasodilation .
RESULTS	Fifty-eight subjects , including 17 with metabolic syndrome , 13 with atherosclerosis , and 28 healthy controls , were studied .
RESULTS	Among all subjects , endothelium-dependent flow-mediated vasodilation decreased after salsalate compared with placebo therapy ( P = 0.01 ) , whereas nitroglycerin-mediated , endothelium-independent vasodilation was unchanged ( P = 0.97 ) .
RESULTS	Endothelium-dependent flow-mediated vasodilation after salsalate therapy was impaired compared with placebo therapy in subjects with therapeutic salicylate levels ( n = 31 , P < 0.02 ) but not in subjects with subtherapeutic levels ( P > 0.2 ) .
CONCLUSIONS	Salsalate therapy , particularly when therapeutic salicylate levels are achieved , impairs endothelium-dependent vasodilation in a broad range of subjects .
CONCLUSIONS	These data raise concern about the possible deleterious effects of anti-inflammatory doses of salsalate on cardiovascular risk .
BACKGROUND	www.clinicaltrials.gov .
BACKGROUND	Unique Identifiers : NCT00760019 and NCT00762827 .

###24646165
BACKGROUND	Effective strategies to address risk factors of non-communicable diseases are required to curtail the expanding costs of health care .
BACKGROUND	This trial tested the effectiveness over one year of a minimal intervention targeting multiple health behaviours ( diet , physical activity , alcohol and smoking ) in a general practice setting , through the provision of personalised , computer-tailored feedback .
METHODS	Patients who had attended a general practice in the previous 6 months were recruited from 21 general practitioners in Brisbane , Australia .
METHODS	Baseline data were collected using self-reports on adherence to ten health behaviours and summarised into a health score from 0 to 10 .
METHODS	This randomised controlled trial used a 22 factorial design , with one arm randomising subjects to the intervention or control group .
METHODS	The other arm was either feedback at baseline ( single contact ) or an additional assessment with feedback at 3 months ( dual contact ) .
METHODS	As such , 4 study groups created were , to which participants were randomised blindly : A. Intervention with single contact ; B. Intervention with dual contact ; C. Control with single contact and D. Control with dual contact .
METHODS	All participants were assessed again at 12 months .
RESULTS	Of the 4676 participants randomised , 3065 completed questionnaires at 12 months .
RESULTS	Both single and dual contact groups improved their 10 item health scores ( +0.31 and +0.49 respectively ) relative to control group outcomes ( +0.02 ; p < 0.01 ) .
RESULTS	Improvement in adherence to guidelines for fish intake , type of milk consumed , vegetable and fruit intake , and alcohol intake were observed in single and dual contact intervention groups ( p < 0.01 ) .
RESULTS	Both intervention groups showed greater improvement than controls for individual health behaviours , apart from red meat intake , smoking behaviour , physical activity and body weight .
RESULTS	Interestingly , there was an improvement in reported non-smoking rates in both intervention and control groups ( 3 % single contact ; 4.5 % dual contact ) .
CONCLUSIONS	Small but meaningful long-term changes in health behaviours can be achieved with a low-intensity intervention , which may reduce health care costs if implemented on a large scale .
CONCLUSIONS	Further research is needed to better understand the mechanism by which maintenance of behaviour change can be achieved .
BACKGROUND	The Australian New Zealand Clinical Trials Registry : ACTRN12611001213932 .

###25548107
BACKGROUND	( 9 ) - Tetrahydrocannabinol has been shown to modulate anxiety and facilitate the extinction of fear by inhibiting amygdala reactivity .
BACKGROUND	Since functional coupling between the amygdala and prefrontal cortex is implicated in affective processes , it is possible that ( 9 ) - tetrahydrocannabinol affects amygdala-prefrontal cortex functional connectivity in ways that differ across amygdala subregions : basolateral , centromedial , and superficial .
METHODS	The aim of the study was to examine the effects of ( 9 ) - tetrahydrocannabinol on functional connectivity between amygdala subregions and the prefrontal cortex during socio-emotional threat in healthy adults using a double-blind , placebo-controlled , within-subjects design .
METHODS	Sixteen subjects completed a functional magnetic resonance imaging task designed to probe amygdala responses to social threat .
METHODS	Amygdala subregion-prefrontal cortex functional connectivity was compared between ( 9 ) - tetrahydrocannabinol and placebo using generalized psychophysiological interaction analyses .
RESULTS	Findings indicated that ( 9 ) - tetrahydrocannabinol enhanced basolateral and superficial amygdala connectivity to the rostral anterior cingulate/medial prefrontal cortex .
CONCLUSIONS	These effects , including ( 9 ) - tetrahydrocannabinol 's potential ability to reduce threat perception or enhance socio-emotional regulation , may help understand the neurocircuitry of affect .

###25249397
BACKGROUND	A key phenomenon in rheumatoid arthritis is the formation of lymphoid follicles in the inflamed synovial membrane .
BACKGROUND	C-X-C motif chemokine 13 ( CXCL13 ) is central in this process as it attracts C-X-C chemokine receptor type 5 ( CXCR5 ) - expressing B cells and T follicular helper cells to the follicle .
BACKGROUND	We here examine the role of CXCL13 and its association with disease in patients with treatment-nave early rheumatoid arthritis .
METHODS	Plasma samples from patients in the OPERA trial were examined for CXCL13 at treatment initiation and after 6 months of treatment with either methotrexate plus placebo ( DMARD ) ( n = 37 ) or methotrexate plus adalimumab ( DMARD + ADA ) ( n = 39 ) .
METHODS	Treatment outcome was evaluated after 1 and 2 years .
METHODS	CXCL13 plasma levels in healthy volunteers ( n = 38 ) were also examined .
RESULTS	Baseline CXCL13 plasma levels were increased in early rheumatoid arthritis patients in comparison with healthy volunteers .
RESULTS	Also , plasma CXCL13 correlated positively with disease activity parameters ; swollen joint count 28 ( rho = 0.34 ) and 40 ( rho = 0.39 ) , visual analog score ( rho = 0.38 ) and simplified disease activity index ( rho = 0.25 ) ( all P < 0.05 ) .
RESULTS	CXCL13 levels decreased a significantly twofold more in the DMARD + ADA group than in the DMARD group .
RESULTS	Baseline CXCL13 plasma levels in the DMARD group correlated inversely with disease activity parameters ; disease activity score in 28 joints , four variables , C-reactive protein based ( DAS28CRP ) ( rho = 0.58 , P < 0.05 ) at 12 months .
RESULTS	High baseline CXCL13 was associated with remission ( DAS28CRP less than 2.6 ) after 2 years .
CONCLUSIONS	In treatment-nave early rheumatoid arthritis patients , plasma CXCL13 levels were associated with joint inflammation .
CONCLUSIONS	Furthermore , patients with high baseline plasma CXCL13 levels had an improved chance of remission after 2 years .
CONCLUSIONS	We propose that high CXCL13 concentrations indicate recent onset of inflammation that may respond better to early aggressive treatment .
CONCLUSIONS	Thus , high levels of CXCL13 could reflect the ` the window of opportunity ' for optimal treatment effect .
BACKGROUND	Clinicaltrial.gov NCT00660647 .
BACKGROUND	Registered 10 April 2008 .

###25239484
BACKGROUND	Strategies to implement post exposure prophylaxis ( PEP ) in case of an anthrax bioterror event are needed .
BACKGROUND	To increase the number of doses of vaccine available we evaluated reducing the amount of vaccine administered at each of the vaccinations , and reducing the number of doses administered .
METHODS	Healthy male and non-pregnant female subjects between the ages of 18 and 65 were enrolled and randomized 1:1:1:1 to one of four study arms to receive 0.5 mL ( standard dose ) of vaccine subcutaneously ( SQ ) at : ( A ) days 0 , 14 ; ( B ) days 0 and 28 ; ( C ) days 0 , 14 , and 28 ; or ( D ) 0.25 mL at days 0 , 14 , and 28 .
METHODS	A booster was provided on day 180 .
METHODS	Safety was assessed after each dose .
METHODS	Blood was obtained on days 0 , 7 , 14 , 21 , 28 , 35 , 42 , 49 , 56 , 63 , 70 , 84 , 100 , 180 , and 201 and both Toxin Neutralizing antibody and anti-PA IgG antibody measured .
RESULTS	Almost all subjects developed some local reactions with 46-64 % reported to be of moderate severity and 3.3 % severe during the primary series .
RESULTS	Vaccine groups that included a day 14 dose induced a 4 fold antibody rise in more subjects on days 21 , 28 , and 35 than the arm without a day 14 dose .
RESULTS	However , schedules with a full day 28 dose induced higher peak levels of antibody that persisted longer .
RESULTS	The half dose regimen did not induce antibody as well as the full dose study arms .
CONCLUSIONS	Depending on the extent of the outbreak , effectiveness of antibiotics and availability of vaccine , the full dose 0 , 28 or 0 , 14 , 28 schedules may have advantages .

###25461801
BACKGROUND	The development of specific screening programs for individuals with a family history of colorectal cancer ( CRC ) is a priority .
BACKGROUND	This study evaluates the diagnostic performance of serum soluble CD26 ( sCD26 ) in family-risk individuals and compares this marker with the faecal immunochemical test for the detection of advanced neoplasia ( AN ) ( CRC or advanced adenomas ; AA ) .
METHODS	Five hundred and sixteen asymptomatic individuals with at least one first-degree relative with CRC were included .
METHODS	Serum sCD26 was measured in all the individuals who also underwent a colonoscopy ( 53 AA and four cancer cases were found ) and a faecal immunochemical test .
RESULTS	Setting specificity to 90 % and 95 % , respectively , sCD26 showed a sensitivity of 39.6 % and 28.3 % for AA , and of 42.1 % and 28.1 % for AN .
RESULTS	The combination of sCD26 and the faecal test detected AA and AN with a 52.8 % and 56.1 % sensitivity , corresponding to 93.5 % specificity .
CONCLUSIONS	The combination of serum sCD26 and the faecal blood test could result a valuable strategy for detecting AN in familial-risk CRC screening .

###25436296
OBJECTIVE	Ramosetron is a new selective 5-hydroxytryptamine type 3 ( 5-HT3 ) receptor antagonist that reportedly has more potent antiemetic effects than other 5-HT3 receptor antagonists .
OBJECTIVE	The aim of this study was to determine the effect of ramosetron pretreatment on gastric emptying using the 13C-acetic acid breath test .
METHODS	Ten healthy male and female volunteers participated in this randomized , twoway crossover study .
METHODS	After they had fasted overnight , the subjects were randomly assigned to receive 0.1 mg ramosetron 1 hour before ingestion of a test meal ( 200 kcal per 200 mL , containing 100 mg 13C acetate ) or to receive the test meal alone .
METHODS	Under both conditions , breath samples were collected for 150 min following ingestion of the meal .
METHODS	Statistical comparison of the parameters between the two test conditions was performed .
RESULTS	No significant differences in the calculated parameters , including T 1/2 , T lag , GEC or and , were observed between the two test conditions .
CONCLUSIONS	The present study revealed that 0.1 mg ramosetron had no significant effect on the rate of gastric emptying .
CONCLUSIONS	Thus , our results suggest that ramosetron can be administered safely , without gastrointestinal adverse effects , even to terminal cancer patients with delayed or accelerated gastric emptying abnormality .

###24249544
BACKGROUND	Although children with acute lymphoblastic leukemia ( ALL ) mount immune responses after vaccination with the trivalent influenza vaccine ( TIV ) , these responses are lower compared to controls .
BACKGROUND	Recently , a high dose ( HD ) TIV was found to increase the level of antibody response in elderly patients compared to the standard dose ( SD ) TIV .
BACKGROUND	We hypothesized that the HD TIV would be well-tolerated and more immunogenic compared to the SD TIV in pediatric subjects with ALL .
METHODS	This was a randomized , double-blind , phase I safety trial comparing the HD to the SD TIV in children with ALL .
METHODS	Our secondary objective was immunogenicity .
METHODS	Subjects were randomized 2:1 to receive either the HD ( 60 g ) or the SD ( 15 g ) TIV .
METHODS	Local and systemic reactions were solicited , hemagglutinin inhibition titers to influenza virus antigens were measured , and monitoring labs were collected prior to and/or after each vaccination .
RESULTS	Fifty subjects were enrolled ( 34 HD , 16 SD ) .
RESULTS	Mean age was 8.5 years ; 63 % were male , and 80 % were in maintenance therapy .
RESULTS	There were no significant differences reported in local or systemic symptoms .
RESULTS	No severe adverse events were attributed to vaccination .
RESULTS	No significant differences between the HD and SD TIV groups were noted for immune responses .
CONCLUSIONS	No differences were noted between the HD and SD TIV groups for solicited systemic and local reactions .
CONCLUSIONS	Since this study was not powered for immunogenicity , a phase II trial is needed to determine the immunogenicity of HD versus SD TIV in the pediatric ALL population .

###26161612
OBJECTIVE	The objective of this study was to evaluate the efficacy of subcutaneous ( SC ) sedation using midazolam with and without ketamine in non-cooperative pediatric patients undergoing dental treatment .
METHODS	A prospective , randomized , controlled , double-blind , crossover pilot clinical trial was carried out in 13 children , aged between 17-46 months , ASA l , Frankl 1 .
METHODS	Two sedation schemes were administered SC : Midazolam alone ( M ) , and a combination of Midazolam-Ketamine ( MK ) .
METHODS	Both regimens were administered to the same patient in two consecutive treatment sessions , in accordance with a random assignment .
METHODS	Overall behavior , movement , and crying were assessed according to the modified Houpt scale .
METHODS	Heart rate , blood pressure , blood oxygen saturation , and possible side effects were also monitored .
RESULTS	The percentage of non-crying children was always higher in the treatment with MK compared with the treatment with M , but without a significant statistical difference .
RESULTS	Regarding variable body movement , the percentage of children without movement was higher in the MK group , although only up to minute 10 ; no significant differences were found at 20 , 30 , and 40 minutes , and from minute 40 , body movement was lower in the M group .
CONCLUSIONS	Midazolam alone and the midazolam-ketamine combination administered subcutaneously resulted in a safe and efficient pharmacological method for providing moderate sedation to non-cooperative pediatric patients undergoing dental treatment .

###25362163
OBJECTIVE	During atrial fibrillation ( AF ) , conventional electrophysiological techniques for assessment of refractory period or conduction velocity of the atrioventricular ( AV ) node can not be used .
OBJECTIVE	We aimed at evaluating changes in AV nodal properties during administration of metoprolol from electrocardiogram data , and to support our findings with simulated data based on results from an electrophysiological study .
RESULTS	Sixty patients ( age 71 9 years , 42 men ) with permanent AF were included in the RATe control in Atrial Fibrillation ( RATAF ) study .
RESULTS	Two 15 min segments , during baseline and metoprolol administration , starting at 2 pm were analysed in this study .
RESULTS	Atrial fibrillatory rate ( AFR ) , heart rate ( HR ) , and AV nodal parameters were assessed .
RESULTS	The AV nodal parameters account for the probability of an impulse not taking the fast pathway , the absolute refractory periods of the slow and fast pathways ( aRPs and aRPf ) , representing the functional refractory period , and their respective prolongation in refractory period .
RESULTS	In addition , simulated RR series were generated that mimic metoprolol administration through prolonged AV conduction interval and AV node effective refractory period .
RESULTS	During metoprolol administration , AFR and HR were significantly decreased and aRP was significantly prolonged in both pathways ( aRPs : 337 60 vs. 398 79 ms , P < 0.01 ; aRPf : 430 91 vs. 517 100 ms , P < 0.01 ) .
RESULTS	Similar results were found for the simulated RR series , both aRPs and aRPf being prolonged with metoprolol ( aRPs : 413 33 vs. 437 43 ms , P = 0.01 ; aRPf : 465 40 vs. 502 69 ms , P = 0.02 ) .
CONCLUSIONS	The AV nodal parameters reflect expected changes after metoprolol administration , i.e. a prolongation in functional refractory period .
CONCLUSIONS	The simulations confirmed that aRPs and aRPf may serve as an estimate of the functional refractory period .

###25450525
OBJECTIVE	Early handling alters adult behavioral responses to palatable food and to its withdrawal following a period of chronic exposure .
OBJECTIVE	However , the central mechanisms involved in this phenomenon are not known .
OBJECTIVE	Since neonatal handling has persistent effects on stress and anxiety responses , we hypothesized that its involvement in the aforementioned association may be associated with differential neuroadaptations in the amygdala during withdrawal periods .
METHODS	Litters were randomized into two groups : handled ( H , removed from their dam for 10min per day from the first to the tenth postnatal day and placed in an incubator at 32C ) and non-handled ( NH ) .
METHODS	Experiment 1 : on PNDs 80-100 , females were assigned to receive palatable food + rat chow for 15 or 30 days , and these two groups were compared in terms of palatable food preference , body weight and abdominal fat deposition .
METHODS	In Experiment 2 , H and NH rats were exposed to a chronic diet of palatable food + rat chow for 15 days , followed by ( a ) no withdrawal , ( b ) 24h withdrawal from palatable food ( receiving only rat chow ) or ( c ) 7-day withdrawal from palatable food ( receiving only rat chow ) .
METHODS	Body weight , 10-min rebound palatable food intake , abdominal fat deposition , serum corticosterone as well as TH and pCREB levels in the amygdala were then compared between groups .
RESULTS	Experiment 1-chronic exposure to palatable food induces comparable metabolic effects after 15 and 30 days .
RESULTS	Experiment 2-neonatal handling is associated with a peculiar response to palatable food withdrawal following chronic exposure for 15 days .
RESULTS	Rats exposed to early handling ingested less of this food after a 24h withdrawal period , and displayed increased amygdala TH and pCREB levels .
CONCLUSIONS	Variations in the neonatal environment affect both behavioral responses and amygdala neuroadaptation to acute withdrawal from a palatable diet .
CONCLUSIONS	These findings contribute to the comprehension of the mechanisms that link early life events and altered feeding behavior and related morbidities such as obesity in adulthood .

###24433285
BACKGROUND	Hyperuricemia is a risk factor for the onset of chronic kidney disease ( CKD ) and is significantly associated with the progression of CKD .
BACKGROUND	However , there is no sufficient evidence by interventional research supporting a cause-effect relationship .
BACKGROUND	Hyperuricemic patients without gouty arthritis , whose serum urate ( SUA ) concentration is 8.0 mg/dL and who have a complication , are treated by pharmacotherapy in addition to lifestyle guidance .
BACKGROUND	Nevertheless , there is no evidence that rationalizes pharmacotherapy for patients with hyperuricemia who have no complication and whose SUA concentration is below 9.0 mg/dL .
METHODS	The FEATHER ( FEbuxostat versus placebo rAndomized controlled Trial regarding reduced renal function in patients with Hyperuricemia complicated by chRonic kidney disease stage 3 ) study is a prospective , multicenter , double-blind , randomized , placebo-controlled trial of febuxostat-a novel , nonpurine , selective , xanthine oxidase inhibitor .
METHODS	The present study will enroll , at 64 medical institutions in Japan , 400 Japanese patients aged 20 years or older who have hyperuricemia without gouty arthritis , who present CKD stage 3 , and whose SUA concentration is 7.1-10 .0 mg/dL .
METHODS	Patients are randomly assigned to either the febuxostat or the control group , in which febuxostat tablets and placebo are administered orally , respectively .
METHODS	The dosage of the study drugs should be one 10-mg tablet/day at weeks 1 to 4 after study initiation , increased to one 20-mg tablet/day at weeks 5 to 8 , and elevated to one 40-mg tablet/day at week 9 and then maintained until week 108 .
METHODS	The primary endpoint is estimated glomerular filtration rate ( eGFR ) slope .
METHODS	The secondary endpoints include the amount and percent rate of change in eGFR from baseline to week 108 , the amount and percent rate of change in SUA concentration from baseline to week 108 , the proportion of patients who achieved an SUA concentration6 .0 mg/dL , and the incidence of renal function deterioration .
CONCLUSIONS	The present study aims to examine whether febuxostat prevents a further reduction in renal function as assessed with eGFR in subjects and will ( 1 ) provide evidence to indicate the inverse association between a reduction in SUA concentration and an improvement in renal function and ( 2 ) rationalize pharmacotherapy for subjects and clarify its clinical relevance .
BACKGROUND	UMIN Identifier : UMIN000008343 .

###24315548
OBJECTIVE	To compare the efficacy and safety of cutting balloon angioplasty ( CBA ) versus high-pressure balloon angioplasty ( HPBA ) for the treatment of hemodialysis autogenous fistula stenoses resistant to conventional percutaneous transluminal angioplasty ( PTA ) .
METHODS	In a prospective , randomized clinical trial involving patients with dysfunctional , stenotic hemodialysis arteriovenous fistulas ( AVFs ) , patients were randomized to receive CBA or HPBA if conventional PTA had suboptimal results ( ie , residual stenosis > 30 % ) .
METHODS	A total of 516 patients consented to participate in the study from October 2008 to September 2011 , 85 % of whom ( n = 439 ) had technically successful conventional PTA .
METHODS	The remaining 71 patients ( mean age , 60 y ; 49 men ) with suboptimal PTA results were eventually randomized : 36 to the CBA arm and 35 to the HPBA arm .
METHODS	Primary and secondary target lesion patencies were determined by Kaplan-Meier analysis .
RESULTS	Clinical success rates were 100 % in both arms .
RESULTS	Primary target lesion patency rates at 6 months were 66.4 % and 39.9 % for CBA and HPBA , respectively ( P = .01 ) .
RESULTS	Secondary target lesion patency rates at 6 months were 96.5 % for CBA and 80.0 % for HPBA ( P = .03 ) .
RESULTS	There was a single major complication of venous perforation following CBA .
RESULTS	The 30-day mortality rate was 1.4 % , with one non-procedure-related death in the HPBA group .
CONCLUSIONS	Primary and secondary target lesion patency rates of CBA were statistically superior to those of HPBA following suboptimal conventional PTA .
CONCLUSIONS	For AVF stenoses resistant to conventional PTA , CBA may be a better second-line treatment given its superior patency rates .

###24417987
OBJECTIVE	To assess the efficacy and safety of aranidipine versus retard-released felodipine in Chinese patients with mild-to-moderate essential hypertension .
METHODS	This was a multicenter , randomized , double-blind , placebo and active antihypertensive drug parallel-controlled study .
METHODS	After 2 weeks of placebo run-in period , 315 patients at 6 centers with diastolic blood pressure ( DBP ) between 95 to 109 mm Hg ( 1 mm Hg = 0.133 kPa ) while systolic blood pressure ( SBP ) below 180 mm Hg were randomized to receive aranidipine 5-20 mg/d ( n = 126 ) or retard-released felodipine 5-10 mg/d ( n = 126 ) for 12 weeks .
METHODS	Others ( n = 63 ) received placebo for 4 weeks .
METHODS	Their blood pressures were evaluated at baseline and the end of Weeks 4 , 8 and 12 .
RESULTS	After a 12-week treatment , SBP decreased from 148.8 10.7 mm Hg to ( 132.8 11.2 ) mm Hg while DBP dropped from ( 98.4 2.8 ) mm Hg to ( 83.9 7.5 ) mm Hg .
RESULTS	There were significant differences with the baseline values ( P < 0.0001 ) .
RESULTS	After a 4-week treatment , the reductions of SBP in aranidipine and retard-released felodipine groups were ( 12.1 11.0 ) mm Hg and ( 12.2 11.2 ) mm Hg while the reductions of DBP in two groups ( 11.8 6.9 ) mm Hg and ( 12.1 7.9 ) mm Hg respectively .
RESULTS	The reductions of SBP and DBP in two groups were ( 2.3 8.4 ) mm Hg and ( 4.0 5.1 ) mm Hg and they were significantly superior to that in placebo group ( P < 0.0001 ) .
RESULTS	But no significant difference existed between aranidipine and retard-released felodipine groups .
RESULTS	Also no significant differences were found between these two antihypertensive therapy groups at the end of Weeks 4 , 8 and 12 in the reduction of blood pressure , total response rate and blood pressure control rate .
RESULTS	But 20 mg daily aranidipine was significantly superior to 10 mg daily retard-released felodipine in the control rates of SBP and DBP .
RESULTS	Adverse events occurred at 24.22 % and 29.92 % in aranidipine and retard-released felodipine groups respectively ( P = 0.305 ) .
CONCLUSIONS	Administration of aranidipine 5-20 mg/d can effectively control blood pressure and is not inferior to retard-released felodipine 5-10 mg/d .
CONCLUSIONS	The efficacy of 20 mg/d aranidipine is superior to that of retard-released felodipine 5-10 mg/d .
CONCLUSIONS	And the effectiveness and safety of aranidipine are similar to those of retard-released felodipine .

###24889273
OBJECTIVE	The Tisseel/Tissucol for mesh fixation in Lichtenstein hernia repair ( TIMELI ) study showed that mesh fixation with human fibrin sealant during inguinal hernia repair significantly reduced moderate-severe complications of pain 12months post-operatively compared with sutures .
OBJECTIVE	Further analyses may assist surgeons by investigating predictors of post-surgical complications and identifying patients that may benefit from Tisseel/Tissucol intervention .
METHODS	Univariate and multivariate analyses identified risk factors for combined pain , numbness and groin discomfort ( PND ) visual analogue scale ( VAS ) score 12months post-operatively .
METHODS	Variables tested were : fixation method , age , employment status , physical activity , nerve handling , PND VAS score at pre-operative visit and 1week post-operatively .
METHODS	The effect of fixation technique on separate PND outcomes 12months post-surgery was also assessed .
METHODS	Analyses included the intention-to-treat ( ITT ) population and a subpopulation with pre-operative PND VAS > 30mm .
RESULTS	316 patients were included in the ITT , with 130 patients in the subpopulation with pre-operative PND VAS > 30 .
RESULTS	Multivariate analysis identified mesh fixation with sutures , worsening pre-operative PND and worsening PND 1week post-surgery as significant predictors of 12-month PND in the ITT population ; mesh fixation with sutures was a significant predictor of 12-month PND in the pre-operative PND VAS > 30 subpopulation ( p < 0.05 ) .
RESULTS	Mesh fixation with Tisseel/Tissucol resulted in significantly less numbness and a lower intensity of groin discomfort compared with sutures at 12months ; there was no difference in pain between the treatment groups .
CONCLUSIONS	Pre-operative discomfort may be an important predictor of post-operative pain , numbness and discomfort .
CONCLUSIONS	Tisseel/Tissucol may improve long-term morbidity over conventional sutures in these patients .

###24952307
OBJECTIVE	To determine whether abagovomab induces protective immune responses in ovarian cancer patients in first clinical remission .
OBJECTIVE	The present analysis is a substudy of monoclonal antibody immunotherapy for malignancies of the ovary by subcutaneous abagovomab trial ( NCT00418574 ) .
METHODS	The study included 129 patients , 91 in the abagovomab arm and 38 in the placebo arm .
METHODS	Circulating CA125-specific cytotoxic T lymphocytes ( CTL ) were measured by a flow cytometry-based interferon - producing assay .
METHODS	Human antimouse antibody and anti-anti-idiotypic ( Ab3 ) were assessed by ELISA .
METHODS	Patients were evaluated before starting the treatment and at different time points during induction and maintenance phases .
RESULTS	A similar percentage of patients in both the placebo and abagovomab arms had CA125-specific CTL ( 26.3 and 31.8 % , respectively ; p = 0.673 by Fisher 's exact test ) .
RESULTS	Patients with CA125-specific CTL in both arms tended to have an increased relapse-free survival ( RFS , log-rank test p = 0.095 ) compared to patients without .
RESULTS	Patients ( n = 27 ) in the abagovomab arm without CA125-specific CTL but that developed Ab3 above the cutoff ( defined as median Ab3 level at week 22 ) had a prolonged RFS compared to patients ( n = 24 ) that did not develop Ab3 above the cutoff ( log-rank test p = 0.019 ) .
CONCLUSIONS	Abagovomab does not induce CA125-specific CTL .
CONCLUSIONS	However , patients with CA125-specific CTL perform better than patients without , irrespective of abagovomab treatment .
CONCLUSIONS	Abagovomab-induced Ab3 associate with prolonged RFS in patients without CA125-specific CTL .
CONCLUSIONS	Further studies are needed to confirm these data and to assess the potential utility of these immunological findings as a tool for patient selection in clinical trial .

###26022815
BACKGROUND	Indoor exposure to fine particulate matter ( PM2 .5 ) from outdoor sources is a major health concern , especially in highly polluted developing countries such as China .
BACKGROUND	Few studies have evaluated the effectiveness of indoor air purification on the improvement of cardiopulmonary health in these areas .
OBJECTIVE	This study sought to evaluate whether a short-term indoor air purifier intervention improves cardiopulmonary health .
METHODS	We conducted a randomized , double-blind crossover trial among 35 healthy college students in Shanghai , China , in 2014 .
METHODS	These students lived in dormitories that were randomized into 2 groups and alternated the use of true or sham air purifiers for 48 h with a 2-week washout interval .
METHODS	We measured 14 circulating biomarkers of inflammation , coagulation , and vasoconstriction ; lung function ; blood pressure ( BP ) ; and fractional exhaled nitric .
METHODS	We applied linear mixed-effect models to evaluate the effect of the intervention on health outcome variables .
RESULTS	On average , air purification resulted in a 57 % reduction in PM2 .5 concentration , from 96.2 to 41.3 g/m3 , within hours of operation .
RESULTS	Air purification was significantly associated with decreases in geometric means of several circulating inflammatory and thrombogenic biomarkers , including 17.5 % in monocyte chemoattractant protein-1 , 68.1 % in interleukin-1 , 32.8 % in myeloperoxidase , and 64.9 % in soluble CD40 ligand .
RESULTS	Furthermore , systolic BP , diastolic BP , and fractional exhaled nitrous oxide were significantly decreased by 2.7 % , 4.8 % , and 17.0 % in geometric mean , respectively .
RESULTS	The impacts on lung function and vasoconstriction biomarkers were beneficial but not statistically significant .
CONCLUSIONS	This intervention study demonstrated clear cardiopulmonary benefits of indoor air purification among young , healthy adults in a Chinese city with severe ambient particulate air pollution .
CONCLUSIONS	( Intervention Study on the Health Impact of Air Filters in Chinese Adults ; NCT02239744 ) .

###24513442
OBJECTIVE	To determine the effect of antenatal dietary and lifestyle interventions on health outcomes in overweight and obese pregnant women .
METHODS	Multicentre randomised trial .
METHODS	We utilised a central telephone randomisation server , with computer generated schedule , balanced variable blocks , and stratification for parity , body mass index ( BMI ) category , and hospital .
METHODS	Three public maternity hospitals across South Australia .
METHODS	2212 women with a singleton pregnancy , between 10 +0 and 20 +0 weeks ' gestation , and BMI 25 .
METHODS	1108 women were randomised to a comprehensive dietary and lifestyle intervention delivered by research staff ; 1104 were randomised to standard care and received pregnancy care according to local guidelines , which did not include such information .
METHODS	Incidence of infants born large for gestational age ( birth weight 90th centile for gestation and sex ) .
METHODS	Prespecified secondary outcomes included birth weight > 4000 g , hypertension , pre-eclampsia , and gestational diabetes .
METHODS	Analyses used intention to treat principles .
RESULTS	2152 women and 2142 liveborn infants were included in the analyses .
RESULTS	The risk of the infant being large for gestational age was not significantly different in the two groups ( lifestyle advice 203/1075 ( 19 % ) v standard care 224/1067 ( 21 % ) ; adjusted relative risk 0.90 , 95 % confidence interval 0.77 to 1.07 ; P = 0.24 ) .
RESULTS	Infants born to women after lifestyle advice were significantly less likely to have birth weight above 4000 g ( lifestyle advice 164/1075 ( 15 % ) v standard care 201/1067 ( 19 % ) ; 0.82 , 0.68 to 0.99 ; number needed to treat ( NNT ) 28 , 15 to 263 ; P = 0.04 ) .
RESULTS	There were no differences in maternal pregnancy and birth outcomes between the two treatment groups .
CONCLUSIONS	For women who were overweight or obese , the antenatal lifestyle advice used in this study did not reduce the risk delivering a baby weighing above the 90th centile for gestational age and sex or improve maternal pregnancy and birth outcomes .
BACKGROUND	Australian and New Zealand Clinical Trials Registry ( ACTRN12607000161426 ) .

###24302542
BACKGROUND	Observationally lower testosterone is associated with an unhealthier cardiovascular ( CVD ) risk profile , but this association is open to confounding and reverse causality .
BACKGROUND	The authors examined the association of testosterone with well-established cardiovascular disease ( CVD ) risk factors ( blood pressure , low-density lipoprotein ( LDL ) cholesterol , high-density lipoprotein ( HDL ) cholesterol and fasting glucose ) and the Framingham score using a Mendelian randomization analysis with a separate-sample instrumental variable estimator .
METHODS	To minimize reverse causality , a genetic score predicting testosterone was developed in 289 young Chinese men from Hong Kong , based on three selected testosterone-related single nucleotide polymorphisms ( rs10046 , rs1008805 and rs1256031 ) .
METHODS	Multivariable censored and linear regressions were used to examine the association of genetically predicted testosterone levels with CVD risk factors and Framingham score among 4212 older Chinese men from the Guangzhou Biobank Cohort Study .
RESULTS	Predicted testosterone was unrelated to systolic blood pressure [ -0.11 mmHg , 95 % confidence interval ( CI ) -0.70 to 0.48 ] , diastolic blood pressure ( 0.04 mmHg , 95 % CI -0.27 to 0.36 ) , fasting glucose ( 0.02 mmol/l , 95 % CI -0.02 to 0.06 ) or Framingham score ( 0.02 , 95 % CI -0.0001 to 0.03 ) but associated with higher LDL-cholesterol ( 0.02 mmol/l , 95 % CI 0.01 to 0.04 ) and lower HDL-cholesterol ( -0.01 mmol/l , 95 % CI -0.02 to -0.001 ) , after adjustment for potential confounders ( age , education , smoking status , use of alcohol and body mass index ) .
CONCLUSIONS	Our findings did not corroborate observed protective effects of testosterone on cardiovascular risk factors or risk of ischaemic heart disease among men , but raises the possibility that higher testosterone may be associated with an unhealthier lipid profile .

###24947578
BACKGROUND	Rehabilitation of impaired cognitive functions begins to be considered a standard component of medical care after acquired brain injury .
BACKGROUND	Indeed , many evidences support the effectiveness of the two major categories of techniques , i.e. the traditional and computer-assisted ones , which are widely used in cognitive rehabilitative treatment .
OBJECTIVE	Aim of this study is to evaluate the effects of pc - cognitive training in brain injury patients .
METHODS	We studied 35 subjects ( randomly divided into two groups ) , affected by traumatic or vascular brain injury , having attended from January 2010 to December 2012 the Laboratory of Robotic and Cognitive Rehabilitation of IRCCS Neurolesi of Messina .
METHODS	Cognitive impairment was investigated through psychometric battery , administered before ( T0 ) and two months ( T1 ) after the cognitive pc-training , which was performed only by the experimental group , in addition to conventional treatment .
METHODS	Statistical analysis was performed using Wilcoxon test with a p < 0.01 .
RESULTS	At time T0 , all patients showed language deficits and cognitive alterations in visual attention and memory abilities .
RESULTS	After the rehabilitation program we noted a global improvement in both the groups .
RESULTS	However , at T1 , the experimental group showed a greater cognitive improvement than the control group , with significant differences in nearly all the neuropsychological tests performed .
CONCLUSIONS	Our data suggest that cognitive pc-training may be a promising methodology to optimize the rehabilitation outcomes following brain injury .

###24886541
BACKGROUND	Study C210 was a Phase IIa , exploratory trial to assess the activity of telaprevir on hepatitis C virus ( HCV ) early viral kinetics in treatment-nave patients infected with genotype 4 ( G4 ) HCV .
METHODS	Patients were randomized to receive peginterferon and ribavirin alone , telaprevir monotherapy ( T arm ) , or telaprevir in combination with peginterferon/ribavirin ( TPR arm ) for 15days , followed by a 46 - or 48-week standard treatment phase .
METHODS	The current analysis aimed to characterize the genotype and phenotype of HCV G4 variants emerging during telaprevir treatment .
RESULTS	Five of the 8 ( 62.5 % ) patients in the telaprevir ( T ) arm had viral breakthrough ( vBT ) during the investigational treatment phase ( between baseline and Day 15 ) , compared to no patients in the TPR arm .
RESULTS	HCV G4 viral variants with a T54A/T mutation were detected in two of these patients , as well as two other patients with detectable HCV RNA at the end of telaprevir treatment .
RESULTS	Emergence of the T54A/T mutation was associated with a 2 - to 4-fold decreased susceptibility to telaprevir .
RESULTS	All patients with vBT during the investigational treatment phase or with a T54A/T mutation achieved undetectable HCV RNA 12 or 24weeks after end of treatment with subsequent peginterferon/ribavirin treatment .
CONCLUSIONS	In this analysis in G4 HCV-infected patients , more patients in the telaprevir monotherapy arm experienced vBT with resistant variants compared to none with telaprevir combination therapy .
CONCLUSIONS	The most commonly selected mutation T54A in telaprevir-treated G4 HCV patients was previously described in the context of G1 infection .
BACKGROUND	The trial was registered with ClinicalTrials.gov ( NCT00580801 ) .

###25459097
OBJECTIVE	The objective was to assess associations between tenofovir disoproxil fumarate-emtricitabine ( TDF-FTC ) exposure and levonorgestrel ( LNG ) concentrations among Kenyan HIV prevention trial participants using Sino-implant ( II ) LNG implants for contraception .
METHODS	Women were offered implants among other contraceptive methods , were randomized to daily TDF-FTC or placebo , and followed monthly up to 56weeks .
METHODS	Associations between TDF-FTC exposure and mean LNG values were analyzed with linear mixed models .
RESULTS	Of 739 women , 29 ( 3.9 % ) received implants with no incident pregnancies and one discontinuation .
RESULTS	Mean LNG concentrations over 56weeks among 28 women contributing data ranged between 214.0 and 659.8 pg/mL with no significant difference between TDF-FTC and placebo arms or between variable levels of TDF-FTC adherence .
CONCLUSIONS	Concomitant TDF-FTC use was not associated with a significant change in plasma LNG concentrations among women using Sino-implant ( II ) in the first year of use .

###25154829
OBJECTIVE	In low-tumor burden follicular lymphoma ( FL ) , maintenance rituximab ( MR ) has been shown to improve progression-free survival when compared with observation .
OBJECTIVE	It is not known whether MR provides superior long-term disease control compared with re-treatment rituximab ( RR ) administered on an as-needed basis .
OBJECTIVE	E4402 ( RESORT ) was a randomized clinical trial designed to compare MR against RR .
METHODS	Eligible patients with previously untreated low-tumor burden FL received four doses of rituximab , and responding patients were randomly assigned to either RR or MR. Patients receiving RR were eligible for re-treatment at each disease progression until treatment failure .
METHODS	Patients assigned to MR received a single dose of rituximab every 3 months until treatment failure .
METHODS	The primary end point was time to treatment failure .
METHODS	Secondary end points included time to first cytotoxic therapy , toxicity , and health-related quality of life ( HRQOL ) .
RESULTS	A total of 289 patients were randomly assigned to RR or MR. With a median follow-up of 4.5 years , the estimated median time to treatment failure was 3.9 years for patients receiving RR and 4.3 years for those receiving MR ( P = .54 ) .
RESULTS	Three-year freedom from cytotoxic therapy was 84 % for those receiving RR and 95 % for those receiving MR ( P = .03 ) .
RESULTS	The median number of rituximab doses was four patients receiving RR and 18 for those receiving MR. There was no difference in HRQOL .
RESULTS	Grade 3 to 4 toxicities were infrequent in both arms .
CONCLUSIONS	In low-tumor burden FL , a re-treatment strategy uses less rituximab while providing disease control comparable to that achieved with a maintenance strategy .

###24402842
BACKGROUND	The impact of perioperative synbiotics on bacterial translocation and subsequent bacteraemia after oesophagectomy is unclear .
BACKGROUND	This study investigated the effect of perioperative synbiotic administration on the incidence of bacterial translocation to mesenteric lymph nodes ( MLNs ) and the occurrence of postoperative bacteraemia .
METHODS	Patients with oesophageal cancer were randomized to receive perioperative synbiotics or no synbiotics ( control group ) .
METHODS	MLNs were harvested from the jejunal mesentery before dissection ( MLN-1 ) and after the restoration of digestive tract continuity ( MLN-2 ) .
METHODS	Blood and faeces samples were taken before and after operation .
METHODS	Microorganisms in each sample were detected using a bacterium-specific ribosomal RNA-targeted reverse transcriptase-quantitative polymerase chain reaction ( RT-qPCR ) method .
RESULTS	Some 42 patients were included .
RESULTS	There was a significant difference between the two groups in detection levels of microorganisms in the MLN-1 samples .
RESULTS	Microorganisms were more frequently detected in MLN-2 samples in the control group than in the synbiotics group ( 10 of 18 versus 3 of 18 ; P = 0035 ) .
RESULTS	In addition , bacteraemia detected using RT-qPCR 1day after surgery was more prevalent in the control group than in the synbiotics group ( 12 of 21 versus 4 of 21 ; P = 0025 ) .
RESULTS	Neutrophil counts on postoperative days 1 , 2 and 7 after surgery were all significantly higher in the control group than in the synbiotics group .
CONCLUSIONS	Perioperative use of synbiotics reduces the incidence of bacteria in the MLNs and blood .
CONCLUSIONS	These beneficial effects probably contribute to a reduction in the inflammatory response after oesophagectomy .
BACKGROUND	ID 000003262 ( University Hospital Medical Information Network , http://www.umin.ac.jp ) .

###24943725
BACKGROUND	Population sequencing ( PS ) has shown that telaprevir-resistant variants are not typically detectable at baseline ( prevalence , 5 % of patients ) , and most variants present at the time of treatment failure are no longer detectable at the end of the study .
METHODS	To gain insight into the evolution of telaprevir-resistant variants , their baseline prevalence and persistence after treatment was investigated using a more sensitive , deep-sequencing ( DS ) technique in a large number of treatment-experienced patients from the REALIZE study who were infected with hepatitis C virus genotype 1 .
RESULTS	Before treatment initiation , telaprevir-resistant variants ( T54A , T54S , or R155K in 1 % -2 % of the viral population ) were detected by DS in a fraction ( 2 % ) of patients for whom PS failed to detect resistance ; these variants were not necessarily detected at the time of treatment failure .
RESULTS	Of 49 patients in whom telaprevir-resistant variants were detected by PS at the time of treatment failure but not at the end of the study , DS revealed the presence of variants ( V36A/L/M , T54S , or R155K in 1 % -36 % of the viral population ) in 16 patients ( 33 % ) at the end of the study .
CONCLUSIONS	Similar to PS findings , DS analysis revealed that the frequency of telaprevir-resistant variants before treatment was also low , and variants detected at the time of treatment failure were no longer detectable in the majority of patients during follow-up .

###25082115
BACKGROUND	Abnormal forms of grief , currently referred to as complicated grief or prolonged grief disorder , have been discussed extensively in recent years .
BACKGROUND	While the diagnostic criteria are still debated , there is no doubt that prolonged grief is disabling and may require treatment .
BACKGROUND	To date , few interventions have demonstrated efficacy .
METHODS	We investigated whether outpatients suffering from prolonged grief disorder ( PGD ) benefit from a newly developed integrative cognitive behavioural therapy for prolonged grief ( PG-CBT ) .
METHODS	A total of 51 patients were randomized into two groups , stratified by the type of death and their relationship to the deceased ; 24 patients composed the treatment group and 27 patients composed the wait list control group ( WG ) .
METHODS	Treatment consisted of 20-25 sessions .
METHODS	Main outcome was change in grief severity ; secondary outcomes were reductions in general psychological distress and in comorbidity .
RESULTS	Patients on average had 2.5 comorbid diagnoses in addition to PGD .
RESULTS	Between group effect sizes were large for the improvement of grief symptoms in treatment completers ( Cohens d = 1.61 ) and in the intent-to-treat analysis ( d = 1.32 ) .
RESULTS	Comorbid depressive symptoms also improved in PG-CBT compared to WG .
RESULTS	The completion rate was 79 % in PG-CBT and 89 % in WG .
CONCLUSIONS	The major limitations of this study were a small sample size and that PG-CBT took longer than the waiting time .
CONCLUSIONS	PG-CBT was found to be effective with an acceptable dropout rate .
CONCLUSIONS	Given the number of bereaved people who suffer from PGD , the results are of high clinical relevance .

###25720622
BACKGROUND	The first CE-approved bioresorbable vascular scaffold ( BVS ) is effective at treating simple lesions and stable coronary artery disease , but it has yet to be assessed versus the best-in-class drug-eluting stents ( DES ) .
OBJECTIVE	This study sought to compare the performance of a BVS with that of everolimus-eluting stents ( EES ) and biolimus-eluting stents ( BES ) in all-comer patients .
METHODS	The EVERBIO II ( Comparison of Everolimus - and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents II ) trial was a single-center , assessor-blinded study of 240 patients randomly assigned in a 1:1:1 ratio to EES , BES , or BVS .
METHODS	The only exclusion criterion was a reference vessel diameter > 4.0 mm , which precluded treatment with BVS .
METHODS	The primary endpoint was angiographic late lumen loss ( LLL ) at 9 months .
METHODS	Secondary endpoints included patient-oriented major acute coronary events ( MACE ) ( death , myocardial infarction [ MI ] , and any revascularization ) , device-oriented MACE ( cardiac death , MI , and target lesion revascularization ) , and stent thrombosis at the 9-month clinical follow-up .
RESULTS	Follow-up angiography was performed in 216 patients ( 90.7 % ) at 9 months .
RESULTS	In-stent LLL was similar between patients treated with BVS ( 0.28 0.39 mm ) and those treated with EES/BES ( 0.25 0.36 mm ; p = 0.30 ) .
RESULTS	Clinical outcomes were similar at 9 months : the patient-oriented MACE rate was 27 % in BVS and 26 % in the EES/BES group ( p = 0.83 ) and the device-oriented MACE rate was 12 % in BVS and 9 % in the EES/BES group ( p = 0.6 ) .
CONCLUSIONS	New-generation metallic DES ( EES/BES ) were not superior to BVS in terms of angiographic LLL and clinical outcomes .
CONCLUSIONS	( Comparison of Everolimus - and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents [ EVERBIO II ] ; NCT01711931 ) .

###24809922
BACKGROUND	Common clinical practice recommends dual antiplatelet therapy ( DAPT ) for transcatheter aortic valve implantation ( TAVI ) .
BACKGROUND	The aim of the study was to evaluate , in a double blind randomized study , the safety of TAVI , with adjunctive pharmacotherapy consisting of single antiplatelet therapy .
RESULTS	From April 2010 to April 2011 , 120 consecutive patients , undergoing TAVI , have been enrolled in the study .
RESULTS	Patients were randomly assigned to DAPT group ( aspirin and clopidogrel 75 mg/qd or ticlopidine 500 mg/bid ) or ASA group ( aspirin only ) .
RESULTS	TAVI device was the Sapien XT-Novaflex Delivery System ( Edwards Lifesciences , Inc. ) .
RESULTS	All patients were followed up to 6 months .
RESULTS	Device success was achieved in 100 % of patients .
RESULTS	No difference in the VARC combined 30 day safety endpoint , all cause and cardiovascular mortality was observed .
RESULTS	At 30 days vascular complications were reduced in the ASA group ( p < 0.05 ) .
RESULTS	No differences in the clinical status were detected between the groups up to 6 months .
CONCLUSIONS	This study suggests that TAVI procedures can be performed without DAPT without increasing the morbidity and mortality .
CONCLUSIONS	These findings , if confirmed in a larger multicenter randomized trial , will no longer support the use of DAPT for TAVI .

###24516018
OBJECTIVE	Patients with 1p/19q codeleted anaplastic oligodendroglial tumors who participated in RTOG ( Radiation Therapy Oncology Group ) 9402 lived much longer after chemoradiotherapy ( CRT ) than radiation therapy ( RT ) alone .
OBJECTIVE	However , some patients with noncodeleted tumors also benefited from CRT ; survival curves separated after the median had been reached , and significantly more patients lived 10 years after CRT than RT. .
OBJECTIVE	Thus , 1p/19q status may not identify all responders to CRT .
METHODS	Using trial data , we inquired whether an IDH mutation or germ-line polymorphism associated with IDH-mutant gliomas identified the patients in RTOG 9402 who benefited from CRT .
RESULTS	IDH status was evaluable in 210 of 291 patients ; 156 ( 74 % ) had mutations .
RESULTS	rs55705857 was evaluable in 245 patients ; 76 ( 31 % ) carried the G risk allele .
RESULTS	Both were associated with longer progression-free survival after CRT , and mutant IDH was associated with longer overall survival ( 9.4 v 5.7 years ; hazard ratio [ HR ] , 0.59 ; 95 % CI , 0.40 to 0.86 ; P = .006 ) .
RESULTS	For those with wild-type tumors , CRT did not prolong median survival ( 1.3 v 1.8 years ; HR , 1.14 ; 95 % CI , 0.63 to 2.04 ; P = .67 ) or 10-year survival rate ( CRT , 6 % v RT , 4 % ) .
RESULTS	Patients with codeleted mutated tumors ( 14.7 v 6.8 years ; HR , 0.49 ; 95 % CI , 0.28 to 0.85 ; P = .01 ) and noncodeleted mutated tumors ( 5.5 v 3.3 years ; HR , 0.56 ; 95 % CI , 0.32 to 0.99 ; P < .05 ) lived longer after CRT than RT. .
CONCLUSIONS	IDH mutational status identified patients with oligodendroglial tumors who did ( and did not ) benefit from alkylating-agent chemotherapy with RT. .
CONCLUSIONS	Although patients with codeleted tumors lived longest , patients with noncodeleted IDH-mutated tumors also lived longer after CRT .

###24284080
BACKGROUND	Despite the widespread use and advancements of mobile technology that facilitate rich communication modes , there is little evidence demonstrating the value of smartphones for effective interclinician communication and knowledge processes .
OBJECTIVE	The objective of this study was to determine the effects of different synchronous smartphone-based modes of communication , such as ( 1 ) speech only , ( 2 ) speech and images , and ( 3 ) speech , images , and image annotation ( guided noticing ) on the recall and transfer of visually and verbally represented medical knowledge .
METHODS	The experiment was conducted from November 2011 to May 2012 at the University Hospital Basel ( Switzerland ) with 42 medical students in a master 's program .
METHODS	All participants analyzed a standardized case ( a patient with a subcapital fracture of the fifth metacarpal bone ) based on a radiological image , photographs of the hand , and textual descriptions , and were asked to consult a remote surgical specialist via a smartphone .
METHODS	Participants were randomly assigned to 3 experimental conditions/groups .
METHODS	In group 1 , the specialist provided verbal explanations ( speech only ) .
METHODS	In group 2 , the specialist provided verbal explanations and displayed the radiological image and the photographs to the participants ( speech and images ) .
METHODS	In group 3 , the specialist provided verbal explanations , displayed the radiological image and the photographs , and annotated the radiological image by drawing structures/angle elements ( speech , images , and image annotation ) .
METHODS	To assess knowledge recall , participants were asked to write brief summaries of the case ( verbally represented knowledge ) after the consultation and to re-analyze the diagnostic images ( visually represented knowledge ) .
METHODS	To assess knowledge transfer , participants analyzed a similar case without specialist support .
RESULTS	Data analysis by ANOVA found that participants in groups 2 and 3 ( images used ) evaluated the support provided by the specialist as significantly more positive than group 1 , the speech-only group ( group 1 : mean 4.08 , SD 0.90 ; group 2 : mean 4.73 , SD 0.59 ; group 3 : mean 4.93 , SD 0.25 ; F2 ,39 = 6.76 , P = .003 ; partial ( 2 ) = 0.26 , 1 - = .90 ) .
RESULTS	However , significant positive effects on the recall and transfer of visually represented medical knowledge were only observed when the smartphone-based communication involved the combination of speech , images , and image annotation ( group 3 ) .
RESULTS	There were no significant positive effects on the recall and transfer of visually represented knowledge between group 1 ( speech only ) and group 2 ( speech and images ) .
RESULTS	No significant differences were observed between the groups regarding verbally represented medical knowledge .
CONCLUSIONS	The results show ( 1 ) the value of annotation functions for digital and mobile technology for interclinician communication and medical informatics , and ( 2 ) the use of guided noticing ( the integration of speech , images , and image annotation ) leads to significantly improved knowledge gains for visually represented knowledge .
CONCLUSIONS	This is particularly valuable in situations involving complex visual subject matters , typical in clinical practice .

###25069747
BACKGROUND	This study investigated whether maintenance temozolomide ( TMZ ) after definitive therapy for locally advanced non-small-cell lung cancer ( NSCLC ) could decrease the incidence of brain metastasis ( BM ) .
METHODS	Eligible patients included those with stage IIIA , IIIB , or IV ( for stage IV , only with malignant pleural/pericardial effusion ) NSCLC with no BM at diagnosis and stable disease , partial response , or complete response after first-line chemotherapy using at least 2 agents .
METHODS	Patients were randomized to observation or TMZ ( 75 mg/m ( 2 ) for 21 consecutive days followed by a 7-day rest for up to 6 cycles or progression ) .
METHODS	The primary end point was incidence of radiographically diagnosed BM within 12 months from day 1 of first-line chemotherapy .
METHODS	Secondary end points included overall survival ( OS ) , time to progression , incidence of BM at first progression , and toxicity .
RESULTS	The study was closed early on the basis of a futility analysis ; 45 of 53 enrolled patients were evaluable from an original target of 100 .
RESULTS	No difference was noted in the incidence of BM at 1 year in the TMZ and observation groups ( 18 % and 13 % , respectively ) , in median time to progression ( 11.7 and 10.7 months , respectively ) , or in median OS ( 27.1 and 22.5 months , respectively ) .
RESULTS	Common Terminology Criteria for Adverse Events grade 3 or 4 adverse events were 46 % in the TMZ group and 19 % in the observation group .
CONCLUSIONS	TMZ monotherapy does not appear to decrease the incidence of BM in patients with locally advanced NSCLC .
CONCLUSIONS	These results considered in the context of the existing literature have implications for future clinical trial design .

###24560401
OBJECTIVE	The international multicentre FAME Study ( n = 1,005 ) demonstrated significant health benefits for patients undergoing multivessel percutaneous coronary intervention ( PCI ) guided by fractional flow reserve ( FFR ) measurement compared with angiography guidance alone ( ANGIO ) .
OBJECTIVE	We determined the cost-effectiveness and the public health/budget impact for Australia .
METHODS	We performed a prospective economic evaluation comparing FFR vs. ANGIO in patients with multivessel disease based on original patient-level FAME data .
METHODS	We used Australian utilities ( EQ-5D ) and costs to calculate quality-adjusted life years ( QALYs ) and incremental cost-effectiveness adopting the societal perspective .
METHODS	The public health and budget impact from the payer 's perspective was based on Australian PCI registries .
METHODS	Uncertainty was explored using deterministic sensitivity analyses and the bootstrap method ( n = 5,000 samples ) .
RESULTS	The cost-effectiveness analysis showed that FFR was cost-saving and reduces costs by 1,776 AUD per patient during one year .
RESULTS	Over a two-year time horizon , the public health impact ranged from 7.8 to 73.9 QALYs gained and the budget impact from 1.8 to 14.5 million AUD total cost savings .
RESULTS	Sensitivity analyses demonstrated that FFR was cost-saving over a wide range of assumptions .
CONCLUSIONS	FFR-guided PCI in patients with multivessel coronary disease substantially reduces cardiac events , improves QALYs and is cost-saving in the Australian health care system .

###24526141
BACKGROUND	This study aimed to evaluate the feasibility of non-contrast-enhanced 4D magnetic resonance angiography ( NCE 4D MRA ) with signal targeting with alternative radiofrequency ( STAR ) spin labeling and variable flip angle ( VFA ) sampling in the assessment of dural arteriovenous fistula ( DAVF ) in the transverse sinus .
METHODS	Nine patients underwent NCE 4D MRA for the evaluation of DAVF in the transverse sinus at 3T .
METHODS	One patient was examined twice , once before and once after the interventional treatment .
METHODS	All patients also underwent digital subtraction angiography ( DSA ) and/or contrast-enhanced magnetic resonance angiography ( CEMRA ) .
METHODS	For the acquisition of NCE 4D MRA , a STAR spin tagging method was used , and a VFA sampling was applied in the data readout module instead of a constant flip angle .
METHODS	Two readers evaluated the NCE 4D MRA data for the diagnosis of DAVF and its type with consensus .
METHODS	The results were compared with those from DSA and/or CEMRA .
RESULTS	All patients underwent NCE 4D MRA without any difficulty .
RESULTS	Among seven patients with patent DAVFs , all cases showed an early visualization of the transverse sinus on NCE 4D MRA .
RESULTS	Except for one case , the type of DAVF of NCE 4D MRA was agreed with that of reference standard study .
RESULTS	Cortical venous reflux ( CVR ) was demonstrated in two cases out of three patients with CVR .
CONCLUSIONS	NCE 4D MRA with STAR tagging and VFA sampling is technically and clinically feasible and represents a promising technique for assessment of DAVF in the transverse sinus .
CONCLUSIONS	Further technical developments should aim at improvements of spatial and temporal coverage .

###24773830
BACKGROUND	Non-cystic fibrosis bronchiectasis is characterized by the irreversible dilatation of the medium-sized bronchi as a result of airway injury from recurrent or chronic inflammation and lower respiratory tract infections .
BACKGROUND	Bronchiectasis airways are commonly colonized with bacterial species .
BACKGROUND	Infections of the airways play important role in bronchiectasis exacerbations .
BACKGROUND	The non-specific prevention of recurrent airway infections by immunostimulating agents has gained growing interest .
BACKGROUND	OM-85 , consisting of extracts of eight kinds of bacteria important in respiratory infections , could support the respiratory tract resistance to the pathogens .
BACKGROUND	OM-85 has been shown to be a benefit by decreasing the risk of acute exacerbation of chronic obstructive pulmonary disease ( COPD ) in several perspective clinical trials .
BACKGROUND	Exacerbation of bronchiectasis substantially contributes to a more rapid decline in lung function , reduced quality of life , and healthcare costs .
BACKGROUND	In this context , we plan to conduct a clinical trial to investigate the PReventive effect of OM-85 on Bronchiectasis Exacerbation in Chinese patients ( iPROBE ) .
METHODS	This study is designed as a prospective , randomized , double blind , placebo-controlled multicenter trial .
METHODS	A total of 244 patients with bronchiectasis , who have had at least one exacerbation of bronchiectasis in the previous year , will be included .
METHODS	The subjects will randomly receive two courses of 7 mg of OM-85 or a matching placebo .
METHODS	The treatment dose of OM-85 will be one daily capsule taken orally for 10 days each month for 3 consecutive months at the beginning of the study , followed by 3 months of no drug .
METHODS	This schedule will repeat until the patient has been seen for one year .
CONCLUSIONS	We will investigate whether long-term treatment with an oral immunostimulant ( OM-85 ) could decrease exacerbations of bronchiectasis over a one-year period .
CONCLUSIONS	We will also assess other relevant outcomes , including the rate of event-based exacerbation , lung function parameters , and total scores judged by the St George 's respiratory questionnaire , Leicester cough questionnaire , and inflammatory index .
CONCLUSIONS	We hope that this study will provide new information on the preventive effects of OM-85 on bronchiectasis exacerbations and will address a knowledge gap for this understudied disease .
BACKGROUND	This study is registered at http://www.clinicaltrials.gov ( identifier NCT01968421 ) on 19 October 2013 .

###24889731
BACKGROUND	Dipeptidyl peptidase ( DPP ) -4 inhibitors and sulfonylureas may have different effects on islet function .
BACKGROUND	We designed a new two-step hyperglycemic clamp to further compare the effects of sitagliptin , saxagliptin , and glimepiride on - cell function and the incretin effect .
METHODS	The present study was a four-way cross-over open label randomized study .
METHODS	Twelve healthy male subjects were administered a single dose of sitagliptin ( 100mg ) , saxagliptin ( 5mg ) , glimepiride ( 2mg ) or blank control 2h before undergoing a two-step hyperglycemic clamp ( Step 1 : only intravenous glucose was administered ; Step 2 : i.v. glucose loading was combined with oral glucose consumption ) .
METHODS	Two-phase insulin secretion , glucagon secretion , and incretin levels were measured during the clamp .
RESULTS	In Step 1 , with i.v. glucose only , there were no differences between the effects of the three drugs on insulin secretion , except that saxagliptin increased second-phase insulin secretion more than glimepiride ( P = 0.007 ) .
RESULTS	In Step 2 , oral glucose consumption led to an approximate two fold increase in insulin secretion and both gliptins significantly increased first-phase insulin secretion compared with glimepiride ( P = 0.003 for both ) .
RESULTS	Saxagliptin further increased second-phase insulin secretion compared with glimepiride ( P = 0.005 ) and sitagliptin ( P < 0.001 ) .
RESULTS	Both gliptins significantly decreased glucagon secretion and increased active glucagon-like peptide-1 ( GLP-1 ) compared with glimepiride , especially in Step 2 .
CONCLUSIONS	The two-step hyperglycemic clamp appears to be a precise method to assess - cell function by taking the effect of incretins into consideration .
CONCLUSIONS	The oral glucose consumption adds to the i.v. glucose infusion , amplifying the differences in the effects of DPP-4 inhibitors and glimepiride on insulin secretion .

###24643755
OBJECTIVE	Exercise induces oxidative stress and causes adaptations in antioxidant defenses .
OBJECTIVE	The aim of the present study was to determine the effects of a 2-month diet supplementation with docosahexaenoic acid ( DHA ) on the pro-oxidant and antioxidant status of peripheral blood mononuclear cells ( PBMCs ) during football training and after acute exercise .
METHODS	Fifteen male football players , in a randomized double-blind trial , ingested a beverage enriched with DHA or a placebo for 8 weeks .
METHODS	Blood samples were collected in basal conditions before and after the training period and after an acute and intense exercise .
RESULTS	The training season increased the carbonyl and nitrotyrosine index but decreased the malondialdehyde ( MDA ) levels .
RESULTS	Basal catalase activity decreased in both groups after 8 weeks of training , whereas glutathione peroxidase activity increased mainly in the placebo group .
RESULTS	Protein levels of uncoupling proteins ( UCP2 and UCP3 ) and inducible nitric oxide synthase significantly increased after the training period .
RESULTS	Acute exercise induced redistribution in the number of circulating cells , increased the MDA levels and nitrotyrosine index , and decreased the levels of nitrate .
RESULTS	Acute exercise also increased PBMCs reactive oxygen species ( ROS ) production after immune stimulation .
RESULTS	Diet supplementation with DHA significantly increased the UCP3 levels after training and the superoxide dismutase protein levels after acute exercise , and reduced the production of ROS after acute exercise .
CONCLUSIONS	Docosahexaenoic acid increased the antioxidant capabilities while reducing the mitochondrial ROS production in a regular football training period and reduced the oxidative damage markers in response to acute exercise .

###24503679
METHODS	Prospective randomized study .
OBJECTIVE	To compare autologous bone marrow concentrate mixed with allograft cancellous bone to iliac crest autograft in lumbar fusions .
BACKGROUND	Bone marrow has been shown to be a rich source of osteoprogenitor cells .
BACKGROUND	Osteoprogenitor cells have been shown in animals , and some human studies , to have potential in use as a bone graft substitute .
METHODS	Twenty-five patients underwent from 1 - to 3-level lumbar fusions .
METHODS	One patient was lost to follow-up .
METHODS	On one half of the spine , allograft plus autologous bone marrow concentrate was used , whereas on the other half , autologous iliac crest bone was used .
METHODS	Cellular analysis , consisting of nucleated cell count , mononuclear cell count , CD34 + count , and colony-forming-units-fibroblast count , was done on marrow aspirates and concentrates .
METHODS	At 1 year postoperation , computed tomographic scans of the fusions were evaluated on a blinded basis by 2 neuroradiologists independent of each other .
METHODS	Radiographical fusion was the primary outcome measure .
RESULTS	There was no statistical difference in fusion scores between allograft and autograft in the lateral gutters , interbody cages , or facet joints .
RESULTS	There was a positive trend between CD34 + counts and radiographical fusion .
CONCLUSIONS	The study shows equivalence between cancellous allograft mixed with bone marrow concentrate and autologous iliac crest bone for lumbar fusions .
METHODS	2 .

###24318743
BACKGROUND	Platinum-resistant ovarian cancer ( PROC ) constitutes a therapeutic dilemma with limited efficacy from traditional cytotoxic agents .
BACKGROUND	Based on prior data suggesting that scheduling alterations of platinum would increase activity , the aim of the present study was to assess the potential therapeutic benefit of phenoxodiol ( PXD ) , a novel biomodulator shown to have chemoresistance reversing potential , when combined with weekly AUC2-carboplatin in PROC patients .
METHODS	A multicenter randomized double-blind placebo controlled phase-III-study was conducted to compare oral PXD plus AUC2-carboplatin ( group 1 ) versus placebo plus AUC2-carboplatin ( group 2 ) weekly in PROC patients .
METHODS	The primary end point was progression-free-survival ( PFS ) .
METHODS	Secondary objectives included overall survival ( OS ) , response rates , duration of response and quality of life .
RESULTS	The study was terminated early 14 April 2009 , after recruitment of 142 patients due to feasibility and recruitment challenges .
RESULTS	A total of 142 patients were randomized .
RESULTS	The groups were well balanced in terms of important baseline characteristics .
RESULTS	The median PFS for group 1 was 15.4 weeks [ 95 % confidence interval ( CI ) 11.1-21 .0 ] versus 20.1 weeks for group 2 ( 95 % CI = 13.1-33 .4 ) ; P = 0.3 .
RESULTS	The objective response rate and median survival in group 1 versus group 2 was 0 % versus 1 % and 38.3 weeks ( 95 % CI 32.0-45 .3 ) versus 45.7 weeks ( 95 % CI 35.6-58 .0 ) , respectively .
RESULTS	PXD appeared to be well tolerated .
RESULTS	The main reason for dose modification in both groups was hematologic toxicity .
CONCLUSIONS	Orally delivered PXD showed no evidence of clinical activity , when combined with weekly AUC2-carboplatin in PROC .
CONCLUSIONS	In addition , single-agent weekly AUC2-carboplatin appeared to be inactive by response criteria in a homogenously defined population of PROC .
CONCLUSIONS	This has implications for the design of future studies .

###25181918
BACKGROUND	Left-ventricular ejection fraction ( LVEF ) is regarded as a strong predictor for morbidity and mortality in heart failure patients .
BACKGROUND	The aim of the analysis was to assess the relationship between pre-implant LVEF and outcome of patients with advanced heart failure who received cardiac resynchronization therapy ( CRT ) .
METHODS	We analysed the two-year follow-up of 366 patients who had been enrolled in the MASCOT study which included NYHA class III/IV patients with a class I CRT indication .
METHODS	Pre-implant LVEF was stratified by tertile .
RESULTS	The boundaries for pre-implant LVEF were < 22 % ( n = 128 ; 18.2 + / - 3.1 % ; T ( low ) ) , 22 % to 28 % ( n = 121 ; 25.4 + / - 1.4 % ; T ( middle ) ) and > 28 % ( n = 117 ; 32.6 + / - 3.9 % ; T ( high ) ) for each tertile.Two-year post-implant LVEF was 32.0 + / - 11.5 % ( T ( low ) ) , 33.7 + / - 10.8 % ( T ( middle ) ) and 36.4 + / - 9.9 % ( T ( high ) ) .
RESULTS	T ( Iow ) had a greater increase between pre - and post-implant LVEF compared to T ( middle ) ( P = 0.03 ) and T ( high ) ( P = 0.0001 ) .
RESULTS	NYHA class improved similarly among the three groups as well as the quality of life score .
RESULTS	No significant differences were detected between the three groups for all-cause mortality , cardiac death , all-cause hospitalization , and hospitalization due to worsening heart failure .
CONCLUSIONS	Symptomatic heart failure patients with a wide QRS complex and a severe impaired LV function had a better improvement of their pre-implant LVEF than patients with a more preserved LVEF .
CONCLUSIONS	This may be one reason that in these patient groups long-term morbidity and mortality were not related to their pre-implant LVEF .
CONCLUSIONS	Pre-implant LVEF was in symptomatic CRT patients not predictive for their long-term cardiovascular morbidity and mortality .

###25518506
OBJECTIVE	To examine the antihypertensive effect of the synthetic analogue of the endogenous nitric oxide donors in patients with grades 2-3 hypertension and uncomplicated hypertensive crisis ( HC ) .
METHODS	The study included 30 male patients aged 35 to 73 years ( mean age 55.5 10.8 years ) .
METHODS	All the patients had grades 2-3 essential or secondary hypertension .
METHODS	Thirteen ( 43.3 % ) patients were observed to have signs of HC ; 17 ( 56.7 % ) patients had persistent blood pressure ( BP ) elevation .
METHODS	A dinitrosyl iron complex was injected in a dose of 1.5 or 3 mg per kg of body weight .
METHODS	The purpose of its administration was to lower BP by at least 20 % of its baseline level .
RESULTS	No significant side effects associated with the administration of the test drug were recorded when the clinical trial protocol was implemented .
RESULTS	All the patients reported fever and facial hyperemia during and 10-20 minutes after injection .
RESULTS	They all ( 100 % ) showed efficient blood pressure reduction of at least 20 % of the baseline level .
RESULTS	Blood pressure changes were similar when the agent was administered in doses of 1.5 or 3 mg/kg .
RESULTS	At 6-8 minutes after the drug was injected , there was a maximal decrease in blood pressure , then its gradual rise and stabilization at a lower level than the baseline one within the following 8 hours .
RESULTS	There were no significant differences in the magnitude of a blood pressure reduction after administration of 1.5 and 3 mg/kg .
CONCLUSIONS	The findings suggest that the dinitrosyl iron complex is highly effective in treating uncomplicated HC .
CONCLUSIONS	The antihypertensive effect of the drug persists for 8 hours after its injection , which is very important during prehospital therapy .
CONCLUSIONS	The drug is well tolerated by patients and causes an insignificant number of side effects .

###24246458
OBJECTIVE	1 .
OBJECTIVE	Determine whether stress in preterm infants , measured with salivary cortisol , decreases after five days of Kangaroo Care ( KC ) compared to five days of Standard Care ( SC ) .
OBJECTIVE	2 .
OBJECTIVE	To determine whether kangaroo care provides sustainable pain relief beyond the period of skin-to-skin holding .
METHODS	Preterm infants ( n = 38 ) born at 27-30 weeks gestational age were randomized to either the KC or the SC group and received the allocated intervention starting on day of life ( DOL ) five and continuing for five days .
METHODS	Salivary cortisol was collected on DOL five and again on DOL ten .
METHODS	Differences were analyzed using repeated measures ANOVA and t tests .
METHODS	Pain during nasal suctioning over five days was assessed using the Premature Infant Pain Profile ( PIPP ) .
RESULTS	1 .
RESULTS	Adequate saliva samples for salivary cortisol were collected for 13 KC infants and 11 SC infants .
RESULTS	There was no main effect of group ( p = 0.49 ) , but there was a significant main effect of age ( DOL five versus DOL ten ) , with salivary cortisol levels decreasing in both groups ( p = 0.02 ) .
RESULTS	2 .
RESULTS	Pain scores for both groups ( n = 38 ) indicted mild to moderate pain during suctioning , with no significant difference in pain scores between groups .
CONCLUSIONS	1 .
CONCLUSIONS	KC did not affect salivary cortisol levels in preterm neonates , but levels in both the KC and SC groups decreased over time from DOL five to ten .
CONCLUSIONS	Salivary cortisol may vary with age of infant .
CONCLUSIONS	2 .
CONCLUSIONS	Infants experience pain during routine suctioning and may require pain management .

###25093611
BACKGROUND	Dexamethasone ( DEXA ) is commonly used to reduce brain swelling during neurosurgical procedures .
BACKGROUND	DEXA , however , has many side-effects that can increase the risks of post-operative complications .
BACKGROUND	In contrast , progesterone ( PRO ) has fewer side-effects and has been found to be neuroprotective on traumatic brain injury ( TBI ) .
BACKGROUND	Whether PRO may be used as an alternative to DEXA during routine procedures has not been fully explored .
OBJECTIVE	To compare the effects of DEXA and PRO on surgical brain injury ( SBI ) .
METHODS	Seventy-five adult male Sprague Dawley rats were randomized into five groups : ( 1 ) SBI + drug vehicle ( peanut oil , 1ml kg ( -1 ) ) ; ( 2 ) SBI + DEXA ( 1mg kg ( -1 ) ) ; ( 3 ) SBI + low-dose PRO ( 10mg kg ( -1 ) ) ; ( 4 ) SBI + high-dose PRO ( 20mg kg ( -1 ) ) ; and ( 5 ) sham SBI + drug vehicle .
METHODS	Magnetic resonance imaging study and assessments of brain water content ( BWC ) , blood-brain barrier ( BBB ) permeability , cellular inflammatory responses and matrix metalloproteinase 9 ( MMP-9 ) expression were conducted .
RESULTS	This model consistently resulted in increased BWC and BBB disruption .
RESULTS	PRO reduced astrocyte and microglia responses and attenuated brain oedema with preservation of BBB .
RESULTS	A significant down-regulation of MMP-9 expression occurred in the PRO 20 group .
CONCLUSIONS	PRO is as effective as DEXA in reducing brain oedema and inflammation following SBI ; 10mg kg ( -1 ) of PRO was demonstrated to be more effective in relieving acute cellular inflammatory responses .

###25672923
OBJECTIVE	To assess in multiple sclerosis ( MS ) the effect of intense immunosuppression followed by autologous hematopoietic stem cells transplantation ( AHSCT ) vs mitoxantrone ( MTX ) on disease activity measured by MRI .
METHODS	We conducted a multicenter , phase II , randomized trial including patients with secondary progressive or relapsing-remitting MS , with a documented increase in the last year on the Expanded Disability Status Scale , in spite of conventional therapy , and presence of one or more gadolinium-enhancing ( Gd + ) areas .
METHODS	Patients were randomized to receive intense immunosuppression ( mobilization with cyclophosphamide and filgrastim , conditioning with carmustine , cytosine-arabinoside , etoposide , melphalan , and anti-thymocyte globulin ) followed by AHSCT or MTX 20 mg every month for 6 months .
METHODS	The primary endpoint was the cumulative number of new T2 lesions in the 4 years following randomization .
METHODS	Secondary endpoints were the cumulative number of Gd + lesions , relapse rate , and disability progression .
METHODS	Safety and tolerability were also assessed .
METHODS	Twenty-one patients were randomized and 17 had postbaseline evaluable MRI scans .
RESULTS	AHSCT reduced by 79 % the number of new T2 lesions as compared to MTX ( rate ratio 0.21 , p = 0.00016 ) .
RESULTS	It also reduced Gd + lesions as well as the annualized relapse rate .
RESULTS	No difference was found in the progression of disability .
CONCLUSIONS	Intense immunosuppression followed by AHSCT is significantly superior to MTX in reducing MRI activity in severe cases of MS. These results strongly support further phase III studies with primary clinical endpoints .
CONCLUSIONS	The study was registered as EUDRACT No. 2007-000064-24 .

###25458726
BACKGROUND	Antenatal corticosteroids for pregnant women at risk of preterm birth are among the most effective hospital-based interventions to reduce neonatal mortality .
BACKGROUND	We aimed to assess the feasibility , effectiveness , and safety of a multifaceted intervention designed to increase the use of antenatal corticosteroids at all levels of health care in low-income and middle-income countries .
METHODS	In this 18-month , cluster-randomised trial , we randomly assigned ( 1:1 ) rural and semi-urban clusters within six countries ( Argentina , Guatemala , India , Kenya , Pakistan , and Zambia ) to standard care or a multifaceted intervention including components to improve identification of women at risk of preterm birth and to facilitate appropriate use of antenatal corticosteroids .
METHODS	The primary outcome was 28-day neonatal mortality among infants less than the 5th percentile for birthweight ( a proxy for preterm birth ) across the clusters .
METHODS	Use of antenatal corticosteroids and suspected maternal infection were additional main outcomes .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01084096 .
RESULTS	The ACT trial took place between October , 2011 , and March , 2014 ( start dates varied by site ) .
RESULTS	51 intervention clusters with 47,394 livebirths ( 2520 [ 5 % ] less than 5th percentile for birthweight ) and 50 control clusters with 50,743 livebirths ( 2258 [ 4 % ] less than 5th percentile ) completed follow-up .
RESULTS	1052 ( 45 % ) of 2327 women in intervention clusters who delivered less-than-5th-percentile infants received antenatal corticosteroids , compared with 215 ( 10 % ) of 2062 in control clusters ( p < 00001 ) .
RESULTS	Among the less-than-5th-percentile infants , 28-day neonatal mortality was 225 per 1000 livebirths for the intervention group and 232 per 1000 livebirths for the control group ( relative risk [ RR ] 096 , 95 % CI 087-106 , p = 065 ) and suspected maternal infection was reported in 236 ( 10 % ) of 2361 women in the intervention group and 133 ( 6 % ) of 2094 in the control group ( odds ratio [ OR ] 167 , 133-209 , p < 00001 ) .
RESULTS	Among the whole population , 28-day neonatal mortality was 274 per 1000 livebirths for the intervention group and 239 per 1000 livebirths for the control group ( RR 112 , 102-122 , p = 00127 ) and suspected maternal infection was reported in 1207 ( 3 % ) of 48,219 women in the intervention group and 867 ( 2 % ) of 51,523 in the control group ( OR 145 , 133-158 , p < 00001 ) .
CONCLUSIONS	Despite increased use of antenatal corticosteroids in low-birthweight infants in the intervention groups , neonatal mortality did not decrease in this group , and increased in the population overall .
CONCLUSIONS	For every 1000 women exposed to this strategy , an excess of 35 neonatal deaths occurred , and the risk of maternal infection seems to have been increased .
BACKGROUND	Eunice Kennedy Shriver National Institute of Child Health and Human Development .

###24490152
OBJECTIVE	This study investigates the acute and longitudinal effects of resistance training on occupational muscle activity in office workers with chronic pain .
METHODS	30 female office workers with chronic neck and shoulder pain participated for 10 weeks in high-intensity elastic resistance training for 2 minutes per day ( n = 15 ) or in control receiving weekly email-based information on general health ( n = 15 ) .
METHODS	Electromyography ( EMG ) from the splenius and upper trapezius was recorded during a normal workday .
RESULTS	Adherence to training and control interventions were 86 % and 89 % , respectively .
RESULTS	Compared with control , training increased isometric muscle strength 6 % ( P < 0.05 ) and decreased neck/shoulder pain intensity by 40 % ( P < 0.01 ) .
RESULTS	The frequency of periods with complete motor unit relaxation ( EMG gaps ) decreased acutely in the hours after training .
RESULTS	By contrast , at 10-week follow-up , training increased average duration of EMG gaps by 71 % , EMG gap frequency by 296 % and percentage time below 0.5 % , and 1.0 % EMGmax by 578 % and 242 % , respectively , during the workday in m. splenius .
CONCLUSIONS	While resistance training acutely generates a more tense muscle activity pattern , the longitudinal changes are beneficial in terms of longer and more frequent periods of complete muscular relaxation and reduced pain .

###24308190
OBJECTIVE	To observe the curative effect of acupuncture intervention combined with hyperbaric oxygen chamber treatment for delayed encephalopathy in 32 carbon monoxide ( CO ) poisoning patients .
METHODS	A total of 62 CO poisoning encephalopathy patients were randomized into control group ( n = 30 ) and acupuncture group ( n = 32 ) .
METHODS	Patients of the two groups were all treated with medicines ( energy mixture solution , hormones , brain cell activators , calcium ion blockers , anti-inflammatory agents , etc. ) and hyperbaric oxygen treatment ( oxygen-inhaling for 90 min/time ) .
METHODS	Moreover , patients of the acupuncture group received acupuncture stimulation of bilateral Taixi ( KI 3 ) , Xuanzhong ( GB 39 ) , Hegu ( LI 4 ) , Taichong ( LR 3 ) , and Fengchi ( GB 20 ) .
METHODS	All the treatments were conducted once daily for 30 days .
METHODS	The therapeutic effect of the treatments for neurological function was assessed by NIH Stroke Scale ( NIHSS , 34 points in total ; including 15 items as consciousness , horizontal eye movement , visual power , visual field , facial muscular motion , limb movement , coordination movement , sensory and language levels , etc. ) .
RESULTS	After the treatment , of the 30 and 32 cases in the control and acupuncture groups , 1 and 4 were cured , 3 and 8 experienced marked improvement , 4 and 11 were improved , and 22 and 9 invalid , with the effective rates being 26.1 % and 72.3 % , respectively .
RESULTS	The therapeutic effect of the acupuncture group was significantly superior to that of the control group ( P < 0.05 ) .
RESULTS	The average NIHSS score was 5.01 + / - 0.72 in the acupuncture group , being significantly lower than that ( 8.30 + / - 0.45 ) in the control group ( P < 0.05 ) .
CONCLUSIONS	Acupuncture treatment can effectively strengthen the efficacy of hyperbaric oxygen therapy in the treatment of delayed encephalopathy caused by carbon monoxide poisoning .

###25499545
BACKGROUND	Results of randomised controlled trials of newborn ( age 1-3 days ) vitamin A supplementation have been inconclusive .
BACKGROUND	The WHO is coordinating three large randomised trials in Ghana , India , and Tanzania ( Neovita trials ) .
BACKGROUND	We present the findings of the Neovita trial in Ghana .
METHODS	This study was a population-based , individually randomised , double-blind , placebo-controlled trial in the Brong Ahafo region of Ghana .
METHODS	The trial participants were infants aged at least 2 h , identified at home or facilities on the day of birth or in the next 2 days , able to feed orally , and likely to stay in the study area for at least 6 months .
METHODS	They were randomly assigned ( ratio 1:1 ) to receive either one oral dose of vitamin A ( 50,000 IU ) or placebo immediately after recruitment .
METHODS	The research team and parents of the infants were masked to treatment assignment .
METHODS	Follow-up home visits were undertaken every 4 weeks , when data were recorded for deaths , facility use , and care seeking .
METHODS	The primary outcome was post-supplementation mortality to 6 months of age .
METHODS	Analysis was by intention to treat .
METHODS	Potential adverse events were recorded at 1 and 3 days after supplementation .
METHODS	This trial is registered with the Australian New Zealand Clinical Trials Registry ( ANZCTR ) CTRN12610000582055 .
RESULTS	We assessed 26,414 livebirths for eligibility between Aug 16 , 2010 , and Nov 7 , 2011 .
RESULTS	We recruited 22,955 newborn infants , with 11,474 randomly assigned to receive vitamin A and 11,481 to receive placebo .
RESULTS	Loss to follow-up was low with vital status at 6 months of age reported for 22,698 ( 989 % ) infants .
RESULTS	We recorded 278 post-supplementation deaths to 6 months of age in the vitamin A group ( mortality risk 245 in 1000 supplemented infants ) and 248 deaths in the placebo group ( mortality risk 218 per 1000 supplemented infants ) , relative risk ( RR ) 112 ( 95 % CI 095-133 ; p = 0183 ) and risk difference ( RD ) 266 ( 95 % CI -125 to 657 ; p = 018 ) .
RESULTS	Adverse events within 3 days of supplementation did not differ by trial group .
RESULTS	122 infants died in the first 3 days after supplementation ; 70 ( 06 % ) in the vitamin A and 52 ( 05 % ) in the placebo group ( risk ratio [ RR ] 135 , 95 % CI 094-193 , p = 0102 ) .
RESULTS	53 infants were reported to have a bulging fontanelle ; 32 ( 03 % ) in the vitamin A group and 21 ( 02 % ) in the placebo group ( RR 153 , 088-262 , p = 0130 ) .
CONCLUSIONS	The results of this trial do not support inclusion of newborn vitamin A supplementation as a child survival strategy in Ghana .
BACKGROUND	Bill & Melinda Gates Foundation grant to the WHO .

###24788209
OBJECTIVE	To assess the efficacy of two embolic agents in the treatment of symptomatic uterine leiomyomas .
METHODS	A randomized , prospective , single-center study enrolled 60 women with symptomatic uterine leiomyomas .
METHODS	Uterine artery embolization ( UAE ) with spherical polyvinyl alcohol ( SPVA ) microspheres ( n = 30 ; 700-900 m and 900-1 ,200 m ; near-stasis or stasis endpoint ) and tris-acryl gelatin ( TAG ) microspheres ( n = 30 ; 500-700 m ; `` pruned-tree '' endpoint ) was performed .
METHODS	Infarction rates were calculated for the dominant tumor and for small ( < 2 cm ) and large ( > 2 cm ) nondominant tumors .
METHODS	The primary endpoint was tumor infarction at 24 hours measured by contrast-enhanced magnetic resonance imaging assessed by a blinded reviewer .
RESULTS	Baseline characteristics were similar between groups .
RESULTS	The primary endpoint was similar in both treatments ( 91 % dominant tumor infarction ; SPVA .
RESULTS	86.2 % ; TAG , 93.3 % , P = .35 ) .
RESULTS	Complete infarction ( 100 % ) was also similar between arms at 24 hours and 3 months .
RESULTS	Symptom severity was reduced and quality of life improved equally at 3 and 12 months in each treatment group .
RESULTS	Complications were minor in both groups .
CONCLUSIONS	Uterine leiomyoma infarction at 24 hours and 3 months after treatment with SPVA or TAG microspheres was comparable when using near-stasis as a procedural endpoint with SPVA microspheres .
CONCLUSIONS	Symptom relief was maintained for as long as 12 months for both embolic agents .

###25012265
BACKGROUND	Whereas routine prophylaxis for venous thromboembolism ( VTE ) is frequently utilized in the West , Asian physicians employ it much less often , based on its recorded rarity amongst their patients .
BACKGROUND	This study was designed to examine the incidence of VTE and to determine the optimal method of thromboembolic prophylaxis following gastrectomy for cancer .
METHODS	In this prospective , randomized trial , patients were assigned to either an intermittent pneumatic compression ( IPC ) only or an IPC plus enoxaparin .
METHODS	The primary end point of this study was to determine the VTE incidence rate within 30 days of surgery .
METHODS	A history with physical examinations for VTE and a serum d-dimer test was scheduled on postoperative days ( POD ) 0 , 1 , 4 , and 7 .
METHODS	Duplex ultrasonography ( DUS ) was performed as an objective test for deep vein thrombosis at POD 4 .
METHODS	An interim analysis was performed to determine if it was ethical to continue the study .
METHODS	This clinical trial was registered at www.clinicaltrials.gov ( NCT01448746 ) .
RESULTS	Among the 220 patients , 3 ( all from the IPC group ) were diagnosed with VTE ; these cases were asymptomatic , having been detected only on DUS 4 days after surgery .
RESULTS	Postoperative bleeding occurred in 12 cases , among which 11 patients were in the IPC plus enoxaparin group .
CONCLUSIONS	This interim analysis showed a higher incidence of VTE in the IPC group but a higher bleeding rate in the IPC plus enoxaparin group .
CONCLUSIONS	We expect that this study , once completed , will provide information key to the determination of the optimal method for preventing VTE in Korean gastric cancer patients .

###24703685
BACKGROUND	A number of trials have shown improved radiological alignment following total knee arthroplasty using computer-assisted surgery ( CAS ) compared with conventional surgery .
BACKGROUND	Few studies , however , have looked at functional outcomes .
METHODS	We prospectively studied a cohort of 107 patients that underwent TKA by a single surgeon .
METHODS	Patients were randomised into 3 groups : computer-assisted surgery for both the femur and the tibia , intramedullary guides for both the femur and the tibia , and an intramedullary guide for the femur and an extramedullary guide for the tibia .
METHODS	Patients were followed-up post-operatively with the Short Form Health Survey ( SF-12 ) and Oxford Knee Score ( OKS ) questionnaires .
RESULTS	At a median follow-up of 46 months ( range 30-69 months ) , there was a trend towards higher OKS results in the CAS group , with a mean score of 40.6 in the CAS group compared to 37.6 in the extramedullary group and 36.8 in the intramedullary group .
RESULTS	The difference seen in the OKS between CAS and the conventional groups had a significant unadjusted p-value ( 0.024 ) , and approached significance when adjusted for age and sex ( 0.054 ) .
RESULTS	There was a significant improvement in the OKS when the mechanical axis was within 3 of neutral , versus those outside this range ( median of 41.0 compared to 38.3 , p = 0.045 ) .
CONCLUSIONS	This study shows that clinically significant differences are being seen in functional scores of patients treated with CAS versus conventional guides , at medium-term follow up .
CONCLUSIONS	Our findings reinforce the tenet that a coronal mechanical axis of within 3 of neutral equates to significantly better functional outcomes .

###24885545
BACKGROUND	We aimed to compare patient-controlled thoracic or lumbar epidural analgesia methods after thoracotomy operations .
METHODS	One hundred and twenty patients were prospectively randomized to receive either thoracic epidural analgesia ( TEA group ) or lumbar epidural analgesia ( LEA group ) .
METHODS	In both groups , epidural catheters were administered .
METHODS	Hemodynamic measurements , visual analog scale scores at rest ( VAS-R ) and after coughing ( VAS-C ) , analgesic consumption , and side effects were compared at 0 , 2 , 4 , 8 , 16 , and 24 hours postoperatively .
RESULTS	The VAS-R and VAS-C values were lower in the TEA group in comparison to the LEA group at 2 , 4 , 8 , and 16 hours after surgery ( for VAS-R , P = 0.001 , P = 0.01 , P = 0.008 , and P = 0.029 , respectively ; and for VAS-C , P = 0.035 , P = 0.023 , P = 0.002 , and P = 0.037 , respectively ) .
RESULTS	Total 24-hour analgesic consumption was different between groups ( 175 + / - 20 mL versus 185 + / - 31 mL ; P = 0.034 ) .
RESULTS	The comparison of postoperative complications revealed that the incidence of hypotension ( 21/57 , 36.8 % versus 8/63 , 12.7 % ; P = 0.002 ) , bradycardia ( 9/57 , 15.8 % versus 2/63 , 3.2 % ; P = 0.017 ) , atelectasis ( 1/57 , 1.8 % versus 7/63 , 11.1 % ; P = 0.04 ) , and the need for intensive care unit ( ICU ) treatment ( 0/57 , 0 % versus 5/63 , 7.9 % ; P = 0.03 ) were lower in the TEA group in comparison to the LEA group .
CONCLUSIONS	TEA has beneficial hemostatic effects in comparison to LEA after thoracotomies along with more satisfactory pain relief profile .

###24385283
BACKGROUND	Gemifloxacin is a synthetic fluoroquinolone antimicrobial agent , which has potent activity against most Gram-negative and Gram-positive organisms .
BACKGROUND	It is indicated for the treatment of community-acquired pneumonia and acute bacterial exacerbation of chronic bronchitis .
OBJECTIVE	The aim of this study was to assess the clinical potential of a new gemifloxacin 200 mg intravenous formulation by comparing its pharmacokinetic characteristics with those of the branded Factive ( ) gemifloxacin tablet .
METHODS	A single-dose , open-label , randomized-sequence , two-period crossover study was performed with 17 healthy male volunteers .
METHODS	The two treatment periods were separated by a 1-week washout period .
METHODS	Blood samples were taken for up to 48 h post-dose .
METHODS	Plasma gemifloxacin concentrations were determined by a validated high-performance liquid chromatography-tandem mass spectrometry method .
METHODS	To calculate the pharmacokinetic parameters , noncompartmental analysis was performed .
METHODS	The two formulations were considered to be pharmacokinetically equivalent if the 90 % confidence intervals ( CIs ) of the log-transformed ratios ( intravenous/oral formulations ) of the area under the plasma concentration-time curve ( AUC ) from time zero to the time of the last measurable concentration ( AUClast ) and the AUC from time zero to infinity ( AUC ) were within the standard bioequivalence range ( 0.8-1 .25 ) .
METHODS	Safety and tolerability were evaluated on the basis of physical examinations , vital signs , electrocardiograms , clinical laboratory tests and adverse event monitoring .
RESULTS	Seventeen subjects were enrolled , and 15 subjects completed the study .
RESULTS	Sixteen subjects received intravenous 200 mg gemifloxacin and 15 received oral 320 mg gemifloxacin .
RESULTS	The 15 subjects in the pharmacokinetic analysis set had a mean ( standard deviation [ SD ] ) age , height and weight of 27.2 ( 5.3 ) years , 173.5 ( 4.4 ) cm and 67.3 ( 7.4 ) kg , respectively .
RESULTS	Both formulations had similar pharmacokinetic profiles .
RESULTS	For the intravenous formulation , the mean ( SD ) AUClast , AUC and maximum plasma concentration ( C max ) values were 9.12 ( 4.03 ) gh/mL , 9.26 ( 4.07 ) gh/mL and 2.90 ( 1.65 ) g/mL , respectively , while these values for the oral formulation were 9.44 ( 3.34 ) gh/mL , 9.60 ( 3.49 ) gh/mL and 2.03 ( 0.95 ) g/mL , respectively .
RESULTS	For the intravenous and oral formulations , the median ( range ) time to reach C max ( t max ) values were 0.9 ( 0.7-1 .0 ) and 1.0 ( 0.5-2 .0 ) h , respectively .
RESULTS	The mean relative bioavailability was 68.99 % .
RESULTS	The 90 % CI of the ratios of the log-transformed values of AUClast and AUC was 0.82-1 .07 .
RESULTS	There were no serious adverse events .
RESULTS	The intravenous and oral formulations were associated with treatment-emergent adverse event incidences of 63 % ( 10/16 ) and 13 % ( 2/15 ) , respectively .
RESULTS	After the intravenous formulation was administered , application site pain and paraesthesia were the most frequently reported adverse events ( 31 and 25 % , respectively ) .
RESULTS	All adverse events resolved spontaneously without treatment .
CONCLUSIONS	Intravenous 200 mg and oral 320 mg formulations of gemifloxacin are equivalent in terms of AUC following a single dose in healthy male subjects .

###26137616
OBJECTIVE	To explore the changes of goiter prevalence of children living in areas with high iodine in drinking water after removing iodized salt from their diet .
METHODS	Three towns with median water iodine of 150 - 300 g/L were selected randomly in Hengshui city of Hebei province of China .
METHODS	A total of 452 and 459 children in the 3 towns were randomly selected to measure thyroid volume by ultrasound before and after removing iodized salt , respectively .
METHODS	Their goiter status was judged using the criteria of age-specific thyroid volume recommended by the WHO .
RESULTS	After removing iodized salt , the overall goiter prevalence in the three towns significantly decreased from 24.56 % ( 111/452 ) to 5.88 % ( 27/459 ) ( P < 0.01 ) .
RESULTS	The goiter prevalence in 8 , 9 and 10 year-old children decreased respectively from 33.70 % ( 31/92 ) , 23.32 % ( 45/193 ) and 20.96 % ( 35/167 ) to 6.10 % ( 10/164 ) , 5.52 % ( 9/163 ) and 6.06 % ( 8/132 ) .
RESULTS	The goiter prevalence in boys and girls decreased from 27.05 % ( 66/244 ) and 21.63 % ( 45/208 ) to 6.66 % ( 15/226 ) and 5.15 % ( 12/233 ) , respectively .
RESULTS	The decreases in children 's goiter prevalence across gender and age group were all significant .
CONCLUSIONS	Children 's goiter prevalence decreased significantly after removing iodized salt from their diet for about one and half years in the HIA in Hebei province .

###24308188
OBJECTIVE	To observe the clinical effect and safety of Sulfasalazine ( SASP ) combined with ZHUANG medicine mediated thread moxibustion ( ZMMTM ) for patients with mild and moderate ulcerative colitis ( UC ) .
METHODS	A total of 46 UC patients were randomly and equally divided into moxibustion group ( SASP combined with ZMMTM ) and SASP medication group .
METHODS	Patients of both groups were treated by oral administration of SASP ( 1 g , tid ) for six weeks .
METHODS	For patients of the moxibustion group , ZMMTM was applied to points Tianshu ( ST 25 ) , Qihai ( CV 6 ) , Guanyuan ( CV 4 ) , and Dachangshu ( BL 25 ) , once a day , for 20 times .
METHODS	The therapeutic effect was assessed according to Schroeder and colleagues ' method ( 1987 ) , scores of Baron ' s endoscope scale ( 0 - 9 scoring standards , 1964 ) , 0 - 3 scoring standards of activity indexes ( including 4 items of diarrhea , hemorrhage , mucosal appearance and doctors ' evaluation ) , respectively .
RESULTS	Of the two 32 UC patients in the medication and moxibustion groups , 6 and 9 had a complete remission in their symptoms , 6 and 7 experienced a remarkable improvement , 5 and 6 were effective , and 6 and 1 was invalid , with the effective rates being 73.91 % and 95.65 % , respectively .
RESULTS	Following the treatment , both endoscopic score and activity index in the moxibustion group were significantly lower than those of the medication group ( P < 0.05 ) .
CONCLUSIONS	ZMMTM combined with medication is significantly superior to simple medication in relieving clinical symptoms of mild and moderate UC patients .

###24251641
OBJECTIVE	Any differences observed between natural glucagon-like peptide-1 ( GLP-1 ) and studies obtained with analogues might call for renewed considerations concerning the use and design of such analogues .
OBJECTIVE	Thus , we aimed to evaluate the dose-response relationship of recombinant glucagon-like peptide-1 ( 7-36 ) amide ( rGLP-1 ) administered by continuous subcutaneous infusion ( CSCI ) in subjects with type 2 diabetes .
METHODS	We compared the efficacy and safety of three doses of recombinant GLP-1 , ranging from 1.25 to 5.0 pmol/kg/min ( pkm ) and placebo , given by continuous subcutaneous infusion over 3months in combination with metformin and sulphonylurea ( SU ) , to lower haemoglobin A1c ( HbA1c ) , fasting plasma glucose and weight in 95 type 2 diabetes patients with inadequate glycaemic control .
RESULTS	The mean decreases in HbA1c at endpoint ( week 12 ) were significantly greater for all three rGLP-1 dose groups when each was compared with the placebo group , with the greatest decrease occurring in the 5.0 pkm dose group ( -1.3 % , s.d. 0.18 , p < 0.001 ) .
RESULTS	The mean decreases in fasting plasma glucose from baseline to endpoint were significantly greater for all three rGLP-1 dose groups than for the placebo group , with the greatest decrease occurring in the 5.0 pkm dose group ( -26.0 mg/dl , s.d. 8.5 , p = 0.02 ) .
RESULTS	Body weight was significantly reduced by 1.8 kg ( s.d. 1.3 ) in the 1.25 pkm dose group only ( p = 0.04 ) .
CONCLUSIONS	Administration of rGLP-1 by CSCI over a 12-week period in combination with metformin and an SU had a dose dependent effect in lowering HbA1c and fasting plasma glucose .
CONCLUSIONS	However , administration of rGLP-1 by CSCI may be less effective with respect to lowering of body weight compared with the daily and once weekly analogues .

###24337079
BACKGROUND	BMS-820836 , a novel triple monoamine reuptake inhibitor , is an experimental monotherapy for sufferers of major depressive disorder who have had an inadequate response to an existing antidepressant treatment .
OBJECTIVE	This study was conducted to evaluate the safety and tolerability , pharmacokinetics ( PK ) , and serotonin transporter ( SERT ) and dopamine transporter ( DAT ) occupancy for single doses of BMS-820836 in healthy subjects .
METHODS	Healthy subjects were assigned to seven BMS-820836 dose panels ( 0.025 , 0.1 , 0.5 , 1 , 2 , 3 , and 5 mg ; n = 8 each ) , in which subjects were randomly allocated 3:1 to a single BMS-820836 dose or matched placebo .
METHODS	Serial blood samples were collected on Days 1 , 2 , 3 , 4 , 7 , and 14 to characterize the PK of BMS-820836 .
METHODS	Following evaluation of the maximum tolerated dose , SERT occupancy was determined by applying [ ( 11 ) C ] DASB positron emission tomography ( PET ) after single-dose BMS-820836 ( 0.5 or 3 mg ; n = 3 each ) and DAT occupancy by applying [ ( 11 ) C ] PE2I PET after single-dose BMS-820836 ( 3 mg ; n = 6 ) .
RESULTS	Single oral doses of BMS-820836 ( 0.025-3 mg ) were generally safe and well tolerated .
RESULTS	BMS-820836 had a median T max of 5.0-7 .2 h and a mean apparent terminal T 1/2 of 34-57 h. Mean striatal SERT occupancies were 19 9 % and 82 8 % after single doses of 0.5 and 3 mg BMS-820836 , respectively .
RESULTS	The mean striatal DAT occupancy was 19 9 % after a single 3 mg BMS-820836 dose .
CONCLUSIONS	Single doses of BMS-820836 have meaningful SERT and DAT occupancy and demonstrate an acceptable safety and tolerability profile in healthy control subjects .

###24872136
OBJECTIVE	To evaluate the safety and efficacy of the novel tenofovir prodrug , tenofovir alafenamide ( TAF ) , as part of a single-tablet regimen ( STR ) for the initial treatment of HIV-1 infection .
METHODS	Phase 2 , randomized , double-blind , double-dummy , multicenter , active-controlled study .
METHODS	Antiretroviral naive adults with HIV-1 RNA 5000 copies per milliliter and a CD4 count 50 cells per microliter were randomized 2:1 to receive an STR of elvitegravir/cobicistat/emtricitabine / tenofovir alafenamide ( E/C/F / TAF ) or elvitegravir/cobicistat/emtricitabine / tenofovir disoproxil fumarate ( E/C/F / TDF ) , plus placebo for 48 weeks .
RESULTS	Patients on both E/C/F / TAF ( n = 112 ) and E/C/F / TDF ( n = 58 ) had high rates of virologic suppression ( < 50 HIV copies per milliliter ) at week 24 ( 86.6 % ; 89.7 % ) and at week 48 ( 88.4 % ; 87.9 % ) , and had similar improvements in CD4 at week 48 ( 177 ; 204 ) , respectively .
RESULTS	Both treatments were well tolerated , and most adverse events were self-limiting and of mild to moderate severity .
RESULTS	Compared with patients on E/C/F / TDF , patients on E/C/F / TAF had smaller reductions in estimated creatinine clearance ( -5.5 vs. -10.1 mL/min , P = 0.041 ) , significantly less renal tubular proteinuria , and smaller changes in bone mineral density for hip ( -0.62 % vs. -2.39 % , P < 0.001 ) and spine ( -1.00 % vs. -3.37 % , P < 0.001 ) .
RESULTS	Patients on E/C/F / TAF had higher increases in total cholesterol , low-density lipoprotein , and high-density lipoprotein , but the total cholesterol/high-density lipoprotein ratio was unchanged for both .
CONCLUSIONS	Treatment-naive patients given the STR that contained either TAF or TDF achieved a high rate of virologic success .
CONCLUSIONS	Compared with those receiving TDF , patients on E/C/F / TAF experienced significantly smaller changes in estimated creatinine clearance , renal tubular proteinuria , and bone mineral density .

###25269896
BACKGROUND	Large-scale clinical trials have shown that routine monitoring of the platelet function in patients after percutanous coronary intervention ( PCI ) is not necessary .
BACKGROUND	However , it is still unclear whether patients received high-risk PCI would benefit from a therapy which is guided by a selective platelet function monitoring .
BACKGROUND	This explanatory study sought to assess the benefit of a therapy guided by platelet function monitoring for these patients .
METHODS	Acute coronary syndrome ( ACS ) patients ( n = 384 ) who received high-risk , complex PCI were randomized into two groups .
METHODS	PCI in the two types of lesions described below was defined as high-risk , complex PCI : lesions that could result in severe clinical outcomes if stent thrombosis occurred or lesions at high risk for stent thrombosis .
METHODS	The patients in the conventionally treated group received standard dual antiplatelet therapy .
METHODS	The patients in the platelet function monitoring guided group received an antiplated therapy guided by a modified thromboelastography ( TEG ) platelet mapping : If inhibition of platelet aggregation ( IPA ) induced by arachidonic acid ( AA ) was less than 50 % the aspirin dosage was raised to 200 mg/d ; if IPA induced by adenosine diphosphate ( ADP ) was less than 30 % the clopidogrel dosage was raised to 150 mg/d , for three months .
METHODS	The primary efficacy endpoint was a composite of myocardial infarction , emergency target vessel revascularization ( eTVR ) , stent thrombosis , and death in six months .
RESULTS	This study included 384 patients ; 191 and 193 in the conventionally treated group and platelet function monitoring guided group , respectively .
RESULTS	No significant differences were observed in the baseline clinical characteristics and interventional data between the two groups .
RESULTS	In the platelet function monitoring guided group , the mean IPA induced by AA and ADP were ( 69.2 24.5 ) % ( range , 4.8 % to 100.0 % ) and ( 51.4 29.8 ) % ( range , 0.2 % to 100.0 % ) , respectively .
RESULTS	The AA-induced IPA of forty-three ( 22.2 % ) patients was less than 50 % and the ADP-induced IPA of fifty-seven ( 29.5 % ) patients was less than 30 % ; therefore , their drug dosages were adjusted .
RESULTS	The TEG was rechecked one to four weeks after PCI , and the results indicated that the IPAs had significantly improved ( P < 0.01 ) .
RESULTS	However , no significant differences were found in the rates of the primary efficacy endpoint .
RESULTS	Rates in the conventionally treated group and platelet function monitoring guided group were 4.7 % and 5.2 % , respectively ( hazard ratio : 1.13 ; P = 0.79 ) .
CONCLUSIONS	An antiplatelet therapy guided by TEG monitored platelet function could not improve clinical efficacy even in ACS patients treated with high-risk complex PCI .

###25229980
BACKGROUND	This study was conducted to determine the effect of oral midazolam ( OM ) or intranasal dexmedetomidine ( IND ) on the EC50 of sevoflurane for successful laryngeal mask airway placement in children .
BACKGROUND	We hypothesize that premedication with either agent might reduce the sevoflurane EC50 for laryngeal mask airway placement in children to a similar extent .
METHODS	Fifty-two American Society of Anesthesiologists ( ASA ) I children ( aged 1-6 years ) scheduled for general anesthesia with laryngeal mask airway were randomized to one of the three groups : group M received 0.5 mg kg ( -1 ) OM with honey and intranasal saline , group D received 2 g kg ( -1 ) IND along with oral honey , and group P received oral honey and intranasal saline at least 30 min prior to induction of anesthesia .
METHODS	Anesthesia was induced with incremental sevoflurane up to 8 % in 100 % O2 .
METHODS	A predetermined target endtidal sevoflurane ( ETsevo ) concentration ( 2 % in the first child of all three groups ) was sustained for 10 min before the attempt of laryngeal mask airway insertion by adjusting dial concentration .
METHODS	No intravenous anesthetic or neuromuscular blockade was used .
METHODS	ETsevo was increased/decreased ( step size 0.2 % ) using Dixon 's and Massey 's up and down method in next patient depending upon previous patient 's response .
METHODS	Placement of the laryngeal mask airway without movement , coughing , biting , or bucking was considered as successful .
METHODS	EC50 of sevoflurane was calculated as the average of the crossover midpoints in each group , which was further confirmed by probit analysis .
RESULTS	The EC50 of sevoflurane for laryngeal mask airway placement after OM ( 1.66 0.31 ) and IND ( 1.57 0.14 ) premedications was significantly lower than the placebo group ( 2.00 0.17 , P < 0.0001 ) .
RESULTS	The EC95 ( 95 % CI ) derived from probit regression analysis was 2.34 % ( 2.22-2 .51 % ) with OM , 1.88 % ( 1.77-2 .04 % ) with IND , and 2.39 % ( 2.25-2 .35 % ) with placebo group .
CONCLUSIONS	Oral midazolam and IND premedications significantly reduce the sevoflurane EC50 for laryngeal mask airway insertion in children by 17 % and 21 % , respectively .

###24923077
OBJECTIVE	To evaluate the safety of different doses of subconjunctival bevacizumab and their effects on the recurrence rate after primary pterygium excision .
METHODS	This prospective randomized placebo-controlled clinical study was conducted on 59 eyes ( 59 patients ) .
METHODS	The visual acuity , refractive astigmatism , horizontal length of the pterygium , and recurrence risk factors were recorded .
METHODS	There were no statistically significant differences between the groups for age , sex , horizontal length of pterygium , preoperative visual acuity , astigmatism , and recurrence risk factors .
METHODS	The pterygium was excised from the conjunctival side and then peeled off the cornea .
METHODS	The bare sclera was covered with a rotational conjunctival flap from the superonasal area .
METHODS	After surgery , Group 1 ( 22 patients ) , Group 2 ( 17 patients ) and Group 3 ( 20 patients ) received 7.5 mg bevacizumab , 2.5 mg bevacizumab , and Balanced Salt Solution ( BSS ) subconjunctivally , respectively .
METHODS	Postoperatively , horizontal length of corneal epithelial defect , conjunctival congestion , and lacrimation were checked on the first and seventh day .
METHODS	The rate of recurrence ( > 1.5 mm fibrovascular overgrowth on the cornea ) at month 6 was compared between the groups .
RESULTS	There were no statistically significant differences between the groups for all measured variables except for moderate conjunctival congestion on the first postoperative day which was more common in the bevacizumab groups ( P = 0.002 ) .
RESULTS	Four eyes in Groups 1 ( 20 % ) and 2 ( 26.7 % ) and 3 in Group 3 ( 15.8 % ) experienced recurrence ( p = 0.73 ) .
RESULTS	All recurrences occurred at month 3 and subsequently thereafter .
CONCLUSIONS	In our study , perioperative injections of subconjunctival bevacizumab had no effect on primary pterygium recurrence and were not associated with any specific local complications .

###25498847
BACKGROUND	Although many malaria control programmes in sub-Saharan Africa use indoor residual spraying with long-lasting insecticidal nets ( LLINs ) , the two studies assessing the benefit of the combination of these two interventions gave conflicting results .
BACKGROUND	We aimed to assess whether the addition of indoor residual spraying to LLINs provided a significantly different level of protection against clinical malaria in children or against house entry by vector mosquitoes .
METHODS	In this two-arm cluster , randomised , controlled efficacy trial we randomly allocated clusters of Gambian villages using a computerised algorithm to LLINs alone ( n = 35 ) or indoor residual spraying with dichlorodiphenyltrichloroethane plus LLINs ( n = 35 ) .
METHODS	In each cluster , 65-213 children , aged 6 months to 14 years , were surveyed at the start of the 2010 transmission season and followed in 2010 and 2011 by passive case detection for clinical malaria .
METHODS	Exposure to parasite transmission was assessed by collection of vector mosquitoes with both light and exit traps indoors .
METHODS	Primary endpoints were the incidence of clinical malaria assessed by passive case detection and number of Anopheles gambiae sensu lato mosquitoes collected per light trap per night .
METHODS	Intervention teams had no role in data collection and the data collection teams were not informed of the spray status of villages .
METHODS	The trial is registered at the ISRCTN registry , number ISRCTN01738840 .
RESULTS	LLIN coverage in 2011 was 3510 ( 93 % ) of 3777 children in the indoor residual spraying plus LLIN group and 3622 ( 95.5 % ) of 3791 in the LLIN group .
RESULTS	In 2010 , 7845 children were enrolled , 7829 completed passive case detection , and 7697 ( 98 % ) had complete clinical and covariate data .
RESULTS	In 2011 , 7009 children remained in the study , 648 more were enrolled , 7657 completed passive case detection , and 7545 ( 98.5 % ) had complete data .
RESULTS	Indoor residual spraying coverage per cluster was more than 80 % for both years in the indoor residual spraying plus LLIN group .
RESULTS	Incidence of clinical malaria was 0.047 per child-month at risk in the LLIN group and 0.044 per child-month at risk in the indoor residual spraying plus LLIN group in 2010 , and 0.032 per child-month at risk in the LLIN group and 0.034 per child-month at risk in the indoor residual spraying plus LLIN group in 2011 .
RESULTS	The incident rate ratio was 1.08 ( 95 % CI 0.80-1 .46 ) controlling for confounders and cluster by mixed-effect negative binomial regression on all malaria attacks for both years .
RESULTS	No significant difference was recorded in the density of vector mosquitoes caught in light traps in houses over the two transmission seasons ; the mean number of A gambiae sensu lato mosquitoes per trap per night was 6.7 ( 4.0-10 .1 ) in the LLIN group and 4.5 ( 2.4-7 .4 ) in the indoor residual spraying plus LLIN group ( p = 0.281 in the random-effects linear regression model ) .
CONCLUSIONS	We identified no significant difference in clinical malaria or vector density between study groups .
CONCLUSIONS	In this area with high LLIN coverage , moderate seasonal transmission , and susceptible vectors , indoor residual spraying did not provide additional benefit .
BACKGROUND	UK Medical Research Council .

###24572139
OBJECTIVE	The purpose of the study was to examine changes in quality of life measures in patients who have undergone an intensive exercise program following a single level microdiskectomy .
METHODS	Randomized controlled trial with blinded examiners .
METHODS	The study was conducted in outpatient physical therapy clinics .
METHODS	Ninety-eight participants ( 53 male , 45 female ) who had undergone a single-level lumbar microdiskectomy allocated to receive exercise and education or education only .
METHODS	A 12-week periodized exercise program of lumbar extensor strength and endurance training , and mat and upright therapeutic exercises was administered .
METHODS	Quality of life was tested with the Short Form 36 ( SF-36 ) .
METHODS	Measurements were taken 4-6 weeks postsurgery and following completion of the 12-week intervention program .
METHODS	Since some participants selected physical therapy apart from the study , analyses were performed for both an as-randomized ( two-group ) design and an as-treated ( three-group ) design .
RESULTS	In the two-group analyses , exercise and education resulted in a greater increase in SF-36 scales , role physical ( 17.8 vs. 12.1 ) and bodily pain ( 13.4 vs. 8.4 ) , and the physical component summary ( 13.2 vs. 8.9 ) .
RESULTS	In the three-group analyses , post-hoc comparisons showed exercise and education resulted in a greater increase in the SF-36 scales , physical function ( 10.4 vs. 5.6 ) and bodily pain ( 13.7 vs. 8.2 ) , and the physical component summary ( 13.7 vs. 8.9 ) when compared with usual physical therapy .
CONCLUSIONS	An intensive , progressive exercise program combined with education increases quality of life in patients who have recently undergone lumbar microdiskectomy .

###24798072
OBJECTIVE	To analyze the impact of the eSET followed by single-embryo cryotransfer versus double embryo transfer in older women ( < 38 years ) without taking into account embryo quality .
METHODS	This is a prospective randomised clinical trial performed on 194 couples attempting a first IVF cycle in a Public Hospital in Spain .
METHODS	The women in Group 1 received eSET plus a single-embryo cryotransfer , and those in Group 2 received a double embryo transfer ( DET ) .
RESULTS	In the intention-to-treat analysis , the cumulative live birth delivery rate in the eSET group was similar to the results obtained for the DET group ( 45.2 % vs. 41.8 % ; p = 0.60 ) .
RESULTS	The rate of multiple gestation was significantly lower in the eSET group than in the DET group ( 0 % vs. 26.4 % ; p < 0.05 ) .
RESULTS	The findings obtained in the per-protocol analysis were similar to those obtained in the intention-to-treat analysis .
RESULTS	The per-protocol analysis revealed no significant differences in the rate of implantation ( 29.8 % in eSET vs. 29.7 % in DET ; p = 0.98 ) , in cumulative pregnancy rates per transfer ( 49.1 % in eSET vs. 46.9 % in DET ; p = 0.80 ) or in the cumulative live birth delivery rate ( 38.6 % in eSET vs. 42.2 % in DET ; p = 0.69 ) .
RESULTS	In the cycles with eSET , there were no twin pregnancies ( 0 % in eSET vs. 27.6 in DET ; p < 0.05 ) .
CONCLUSIONS	For women aged under 38 years with good prognosis , without taking embryo quality as a criterion for inclusion , an eSET policy can be applied , achieving acceptable cumulative clinical pregnancy rates and birth rates .

###24490369
OBJECTIVE	To evaluate the effect of nursing intervention on the quality of life of patients with advanced schistosomiasis .
METHODS	A total of 226 cases of advanced schistosomiasis were randomly divided into a control group and an experimental group ( 113 cases each ) .
METHODS	The patients in the control group received the conventional nursing , while the patients in the experimental group received the conventional nursing plus other interventions such as the health education , psychological counseling and diet guidance .
METHODS	The complications and scores of life quality of the patients in the 2 groups were observed and compared .
RESULTS	The awareness of knowledge about the disease improved from 67.7 % to 98.9 % , the incidence of complications decreased from 28.3 % to 13.3 % , and the scores of life quality improved significantly in the experimental group , which were much better than those in the control group .
CONCLUSIONS	The nursing intervention on the quality of life of patients with advanced schistosomiasis is effective .

###24911301
OBJECTIVE	Mentorship within academic institutions influences research productivity ; no published studies have addressed whether encouragement on a national level would have similar effects .
OBJECTIVE	We studied whether contact by a journal 's editorial board members would affect submission rates or journal selection by authors .
METHODS	Authors of potentially publishable conference materials presented at national conferences sponsored by the Society of Teachers of Family Medicine were randomized to receive an invitation to submit work to Family Medicine or to receive no contact .
METHODS	After 2 years , we surveyed authors regarding whether a manuscript had been attempted and , if completed , where it had been submitted and eventually published .
RESULTS	A total of 345 submissions were reviewed , 72 met inclusion criteria , and 41 authors responded to the survey ( 57 % ) .
RESULTS	There were no differences in demographics , scholarly activity in general , or faculty status between study groups .
RESULTS	There was no significant difference in whether manuscripts based on targeted projects had been written , completed , submitted , or published .
RESULTS	There was a significant difference in where manuscripts were submitted with the inviting journal receiving proportionately more submissions from the group of authors that had been contacted ( 90 % Contacted group , 43 % No-Contact ) .
CONCLUSIONS	Simple encouragement from editorial board members of a national peer-reviewed journal in the form of a single e-mail invitation did not increase the scholarly production of authors .
CONCLUSIONS	Encouragement may , however , increase the likelihood that completed works are submitted to the inviting journal , which is a useful finding for journals interested in soliciting scholarly works of interest .

###24841647
OBJECTIVE	The objective of this multicenter , randomized study was to investigate the efficacy of the hydrophilic resorbable film PREVADH in preventing postoperative adhesions following myomectomy .
METHODS	Women scheduled for laparotomic myomectomy with intramural and/or subserous myomas of > 60mm in diameter , and who wished to preserve fertility , were eligible .
METHODS	Patients were randomized immediately prior to abdominal wall closure to receive either hydrophilic resorbable film applied directly to the incisions ( P-Group , n = 33 ) or 500mL Ringer 's lactate solution instilled into the pelvic cavity ( R-Group , n = 28 ) .
METHODS	Incidence , severity , and extent of postoperative adhesions to the uterine incisions and adnexal and abdominopelvic adhesions were assessed during second-look laparoscopy 10-20 weeks after the initial surgery .
METHODS	Unedited videotapes of this second-look procedure were reviewed by two blinded independent surgeons .
RESULTS	Fifty-four patients ( P-Group , n = 28 ; R-Group , n = 26 ) underwent second-look laparoscopy .
RESULTS	Significantly fewer P-Group patients developed adhesions to uterine incisions than R-Group patients ( 43 % vs. 92 % , P = 0.001 ) .
RESULTS	Adhesions , which were confirmed by independent reviewers , were found in significantly fewer P-Group sites than R-Group sites ( 29 % vs. 76 % , P = 0.001 ) .
RESULTS	No serious adverse events related to the barriers used or adhesion-related complications were reported in either group .
CONCLUSIONS	The hydrophilic resorbable anti-adhesion film PREVADH significantly reduced adhesion incidence and severity after laparotomic myomectomy .
BACKGROUND	NCT01388907 ( www.clinicaltrials.gov ) .

###24642379
BACKGROUND	Elevated plasma concentrations of liver function tests are prevalent in patients with chronic heart failure ( HF ) .
BACKGROUND	Little is known about liver function in patients with acute HF .
BACKGROUND	We aimed to assess the prevalence and prognostic value of serial measurements of liver function tests in patients admitted with acute decompensated HF .
METHODS	We investigated liver function tests from all 234 patients from the Relaxin for the Treatment of Patients With Acute Heart Failure study at baseline and during hospitalization .
METHODS	The end points were worsening HF through day 5 , 60-day mortality or rehospitalization , and 180-day mortality .
RESULTS	Mean age was 70 10 years , 56 % were male , and most patients were in New York Heart Association functional class III/IV ( 73 % ) .
RESULTS	Abnormal liver function tests were frequently found for alanine transaminase ( ALT ; 12 % ) , aspartate transaminase ( AST ; 21 % ) , alkaline phosphatase ( 12 % ) , and total bilirubin ( 19 % ) , and serum albumin ( 25 % ) and total protein ( 9 % ) were decreased .
RESULTS	In-hospital changes were very small .
RESULTS	On a continuous scale , baseline ALT and AST were associated with 180-day mortality ( hazard ratios [ HRs ; per doubling ] 1.52 [ P = .030 ] and 1.97 [ P = .013 ] , respectively ) and worsening HF through day 5 ( HRs [ per doubling ] 1.72 [ P = .005 ] and 1.95 [ P = .008 ] , respectively ) .
RESULTS	Albumin was associated with 180-day mortality ( HR 0.86 ; P = .001 ) but not with worsening HF ( HR 0.95 ; P = .248 ) .
RESULTS	Total protein was associated with only worsening HF ( HR 0.91 ; P = .004 ) .
CONCLUSIONS	Abnormal liver function tests are often present in patients with acute HF and are associated with an increased risk for mortality , rehospitalization , and in-hospital worsening HF .

###25468590
OBJECTIVE	To evaluate the effects of epinephrine ( 1:200,000 ) in the epidural space on the incidence of blood vessel injury by epidural catheter insertion for cesarean section .
METHODS	Prospective observational study .
METHODS	University-affiliated teaching hospital .
METHODS	Four hundred laboring women with singleton cephalic presentations at term who underwent cesarean section and requested continuous epidural analgesia .
METHODS	Predistension of 5 mL of isotonic sodium chloride solution containing epinephrine ( 1:200,000 ) or 5 mL of isotonic sodium chloride solution through an epidural needle before catheter insertion .
METHODS	Cases with bloody fluid in the epidural needle or catheter during catheter insertion , aspiration of frank blood from the epidural catheter , and blood noted in the caudal end of the epidural catheter upon removal were recorded .
RESULTS	Eight parturients were excluded from the analysis for technical reasons .
RESULTS	There were no significant differences between patients in the 2 groups with respect to cases with bloody fluid in the epidural needle during catheter insertion ( 7.6 % vs 9.8 % , P = .44 ) , the epidural catheter during catheter placement ( 6.0 % vs 6.7 % , P = .80 ) , aspiration of frank blood in the epidural catheter ( 1.0 % vs 1.0 % , P = .98 ) , and blood noted in the caudal end of the epidural catheter upon removal ( 27.3 % vs 30.4 % ; P > .49 ) .
CONCLUSIONS	Twenty-five micrograms of epinephrine ( 1:200,000 ) in the epidural space does not reduce the incidence of blood vessel injury induced by insertion of an epidural catheter .

###24374880
BACKGROUND	The incidence of vaccine-preventable disease is increasing .
BACKGROUND	Several guidelines recommend annual influenza vaccination for patients with inflammatory bowel disease .
METHODS	Using the Business Objects database of Clalit Health Services in the Tel Aviv district we identified all patients older than 18 years with a diagnosis of Crohn 's disease ( CD ) on December 31 , 2005 .
METHODS	This cohort was followed until December 31 , 2012 .
METHODS	Subjects without inflammatory bowel disease older than 50 years served as controls .
METHODS	The uptake of annual influenza vaccination was recorded .
RESULTS	The study included 515 patients with CD ( 267 [ 51.8 % ] men , age 48.9 17.5 years , disease duration 142.7 56.9 months ) and 2960 controls ( 1262 [ 42.6 % ] men , P < 0.01 , age 68.9 11.1 years , P < 0.01 ) .
RESULTS	The mean number of influenza vaccines received from 2006 to 2012 was 2.08 2.46 and 3.40 2.71 in CD and controls , respectively ( P < 0.01 ) .
RESULTS	Uptake was higher in patients with CD aged 50 to 59 years and 60 to 69 years , compared with controls ( 0.45 0.04 versus 0.24 0.01 , P < 0.01 and 0.64 0.06 versus 0.50 0.01 , P = 0.04 , respectively ) .
RESULTS	Vaccination uptake increased significantly over time in both groups ( P < 0.01 ) .
RESULTS	Predictors of vaccination in CD included age , female sex , immunosuppression , and cardiovascular disease .
CONCLUSIONS	Uptake of influenza vaccination in CD has increased over the past 7 years , and among subjects older than 50 years , uptake remains higher in age-matched controls .
CONCLUSIONS	Nevertheless , overall uptake remains low , particularly in young males .

###25189855
BACKGROUND	Environmental enteric dysfunction ( EED ) is an acquired syndrome of impaired gastrointestinal mucosal barrier function that is thought to play a key role in the pathogenesis of stunting in early life .
BACKGROUND	It has been conceptualized as an adaptive response to excess environmental pathogen exposure .
BACKGROUND	However , it is clinically similar to other inflammatory enteropathies , which result from both host and environmental triggers , and for which immunomodulation is a cornerstone of therapy .
METHODS	In this pilot double-blind randomized placebo-controlled trial , 44 children with severe acute malnutrition and evidence of EED were assigned to treatment with mesalazine or placebo for 28 days during nutritional rehabilitation .
METHODS	Primary outcomes were safety and acceptability of the intervention .
RESULTS	Treatment with mesalazine was safe : there was no excess of adverse events , evidence of deterioration in intestinal barrier integrity or impact on nutritional recovery .
RESULTS	There were modest reductions in several inflammatory markers with mesalazine compared to placebo .
RESULTS	Depression of the growth hormone -- insulin-like growth factor-1 axis was evident at enrollment and associated with inflammatory activation .
RESULTS	Increases in the former and decreases in the latter correlated with linear growth .
CONCLUSIONS	Intestinal inflammation in EED is non-essential for mucosal homeostasis and is at least partly maladaptive .
CONCLUSIONS	Further trials of gut-specific immunomodulatory therapies targeting host inflammatory activation in order to optimize the growth benefits of nutritional rehabilitation and to address stunting are warranted .
CONCLUSIONS	Funded by The Wellcome Trust .
BACKGROUND	Registered at Clinicaltrials.gov NCT01841099 .

###24919727
BACKGROUND	Attenuating postreperfusion syndrome during orthotopic liver transplant is very important for transplant anesthesiologists because of the syndrome 's complications .
BACKGROUND	Oxygen-derived free radicals play an important role in the genesis of postreperfusion syndrome , but the effect of mannitol ( a free radical scavenger ) on attenuating the syndrome is unclear.OBJECTIVES-To investigate the effectiveness of infusing mannitol during the anhepatic phase in preventing postreperfusion syndrome , as indicated by postreperfusion cardiac output and central venous oxygen saturation .
METHODS	In a randomized clinical trial , 53 patients who had undergone orthotopic liver transplant were allocated to 2 groups .
METHODS	During the anhepatic phase , patients in the mannitol group received 1g/kg mannitol , whereas those in the control group received physiological saline .
METHODS	Mean arterial pressure , cardiac output , and central venous oxygen saturation were measured before and after the portal vein was declamped .
METHODS	Serum levels of sodium and potassium were recorded at baseline and after portal vein declamping.Setting-Shiraz Organ Transplant Center , Shiraz , Iran .
RESULTS	In the mannitol group , no significant change was found in mean arterial pressure , cardiac output , and central venous oxygen saturation before and after declamping of the portal vein ( P = .78 , P = .59 , and P = .83 , respectively ) .
RESULTS	However , after declamping in the control group , mean arterial pressure , cardiac output , and central venous oxygen saturation were significantly lower than before declamping ( P = .003 , P = .001 , and P < .001 , respectively ) .
RESULTS	No significant change in serum levels of sodium and potassium from baseline to after declamping were found in either group .
CONCLUSIONS	Infusion of mannitol 1 g/kg during the anhepatic phase was effective in attenuating postreperfusion syndrome without stress about hyperkalemia or hyponatremia during anesthesia .

###24529135
BACKGROUND	Prior studies have found that smokers with STEMI have lower mortality rates and a more favorable response to fibrinolytic therapy than nonsmokers , phenomenon defined as `` the smoker 's paradox '' .
BACKGROUND	Still poorly explored is the impact of cigarette smoking in patients undergoing primary percutaneous coronary intervention .
BACKGROUND	Aim of the current study was to evaluate the impact of cigarette smoking on scintigraphic infarct size in STEMI patients undergoing primary PCI .
METHODS	Our population is represented by 830 STEMI patients undergoing primary PCI .
METHODS	Infarct size was evaluated at 30 days by technetium-99m-sestamibi .
RESULTS	Smoking was associated with younger age ( p < 0.001 ) , a lower prevalence of female gender ( p < 0.001 ) , hypertension ( p < 0.001 ) , diabetes ( p = 0.003 ) , shorter ischemia time ( p = 0.037 ) , but higher rates of previous PCI ( p = 0.016 ) .
RESULTS	No differences were observed in other clinical or angiographic characteristics .
RESULTS	In particular , smoking did not affect the rate of postprocedural TIMI 3 flow .
RESULTS	As shown in Fig. 1 , smoking did not affect infarct size ( 12.5 % [ 3.3 % -23.7 % ] vs 12.7 % [ 4.9 % -25.9 % ] , p = 0.12 ) .
RESULTS	Similar results were observed in subanalyses according to infarct location ( anterior STEMI , p int = 0.33 ) , gender ( p int = 0.95 ) age , ( p Int = 0.96 ) , diabetes ( p int = 0.85 ) .
RESULTS	The absence of any impact of smoking on infarct size was confirmed after correction for baseline characteristics , such as age , gender , hypertension , diabetes , previous PCI , ischemia time ( OR [ 95 % CI ] = 0.80 [ 0.59-1 .09 ] , p = 0.15 ) .
CONCLUSIONS	This study shows that among STEMI patients undergoing primary PCI smoking status does not affect infarct size .

###25102205
OBJECTIVE	Continuous intraoperative norepinephrine infusion combined with restrictive deferred hydration improves surgical field visibility , and significantly decreases intraoperative blood loss and postoperative complications in patients undergoing radical cystectomy and urinary diversion .
OBJECTIVE	We determined whether the intraoperative fluid regimen would affect functional results ( continence and erectile function ) 1 year after orthotopic ileal bladder substitution .
METHODS	We analyzed a subgroup of 93 patients who received an ileal orthotopic bladder substitute .
METHODS	The subgroup was part of a randomized trial in 167 patients initially allocated to continuous norepinephrine administration starting with 2 g/kg per hour combined with 1 ml/kg per hour initially and 3 ml/kg per hour crystalloid infusion after cystectomy ( norepinephrine/low volume group of 51 ) or a standard crystalloid infusion of 6 ml/kg per hour throughout surgery ( 42 controls ) .
METHODS	We prospectively assessed daytime and nighttime continence , and erectile function 1 year postoperatively in the 93-patient subgroup .
RESULTS	Daytime continence was reported by 44 of 51 patients ( 86 % ) in the norepinephrine/low volume group and by 27 of 42 controls ( 64 % ) ( p = 0.016 ) , and nighttime continence was reported by 38 ( 75 % ) and 25 ( 60 % ) , respectively ( p = 0.077 ) .
RESULTS	Erectile function recovery was reported by 26 of 33 preoperatively potent patients ( 79 % ) in the norepinephrine/low volume group and by 11 of 29 controls ( 38 % ) ( p = 0.002 ) .
CONCLUSIONS	Patients who undergo radical cystectomy and orthotopic bladder substitution with continuous norepinephrine infusion and restrictive hydration during surgery have significantly better daytime continence and erectile function 1 year postoperatively .

###25234606
BACKGROUND	Women with depression in pregnancy are faced with difficult treatment decisions .
BACKGROUND	Untreated , antenatal depression has serious negative implications for mothers and children .
BACKGROUND	While antidepressant drug treatment is likely to improve depressive symptoms , it crosses the placenta and may pose risks to the unborn child .
BACKGROUND	Transcranial direct current stimulation is a focal brain stimulation treatment that improves depressive symptoms within 3 weeks of treatment by inducing changes to brain areas involved in depression , without impacting any other brain areas , and without inducing changes to heart rate , blood pressure or core body temperature .
BACKGROUND	The localized nature of transcranial direct current stimulation makes it an ideal therapeutic approach for treating depression during pregnancy , although it has never previously been evaluated in this population .
METHODS	We describe a pilot randomized controlled trial of transcranial direct current stimulation among women with depression in pregnancy to assess the feasibility of a larger , multicentre efficacy study .
METHODS	Women over 18 years of age and between 14 and 32 weeks gestation can be enrolled in the study provided they meet diagnostic criteria for a major depressive episode of at least moderate severity and have been offered but refused antidepressant medication .
METHODS	Participants are randomized to receive active transcranial direct current stimulation or a sham condition that is administered in 15 30-minute treatments over three weeks .
METHODS	Women sit upright during treatment and receive obstetrical monitoring prior to , during and after each treatment session .
METHODS	Depressive symptoms , treatment acceptability , and pregnancy outcomes are assessed at baseline ( prior to randomization ) , at the end of each treatment week , every four weeks post-treatment until delivery , and at 4 and 12 weeks postpartum .
CONCLUSIONS	Transcranial direct current stimulation is a novel therapeutic option for treating depression during pregnancy .
CONCLUSIONS	This protocol allows for assessment of the feasibility of , acceptability of and adherence with a clinical trial protocol to administer this treatment to pregnant women with moderate to severe depression .
CONCLUSIONS	Results from this pilot study will guide the development of a larger multicentre trial to definitively test the efficacy and safety of transcranial direct current stimulation for pregnant women with depression .
BACKGROUND	Clinical Trials Gov NCT02116127 .

###25093663
OBJECTIVE	To compare the analgesic effect of ultrasound-guided Transversus Abdominis Plane ( TAP ) block versus Continuous Wound Infusion ( CWI ) with levobupivacaine after caesarean delivery .
METHODS	We recruited parturients undergoing elective caesareans for this multicenter study .
METHODS	Following written informed consent , they received a spinal anaesthetic without intrathecal morphine for their caesarean section .
METHODS	The postoperative analgesia was randomized to either a bilateral ultrasound guided TAP block ( levobupivicaine = 150 mg ) or a CWI through an elastomeric pump for 48 hours ( levobupivacaine = 150 mg the first day and 12.5 mg/h thereafter ) .
METHODS	Every woman received regular analgesics along with oral morphine if required .
METHODS	The primary outcome was comparison of the 48-hour area under the curve ( AUC ) pain scores .
METHODS	Secondary outcomes included morphine consumption , adverse events , and persistent pain one month postoperatively .
RESULTS	Recruitment of 120 women was planned but the study was prematurely terminated due to the occurrence of generalized seizures in one patient of the TAP group .
RESULTS	By then , 36 patients with TAP and 29 with CWI had completed the study .
RESULTS	AUC of pain at rest and during mobilization were not significantly different : 50 [ 22.5-80 ] in TAP versus 50 [ 27.5-130 ] in CWI ( P = 0.4 ) and 190 [ 130-240 ] versus 160 [ 112.5-247 .5 ] ( P = 0.5 ) , respectively .
RESULTS	Morphine consumption ( 0 [ 0-20 ] mg in the TAP group and 10 [ 0-32 .5 ] mg in the CWI group ( P = 0.09 ) ) and persistent pain at one month were similar in both groups ( respectively 29.6 % and 26.6 % ( P = 0.73 ) ) .
CONCLUSIONS	In cases of morphine-free spinal anesthesia for cesarean delivery , no difference between TAP block and CWI for postoperative analgesia was suggested .
CONCLUSIONS	TAP block may induce seizures in this specific context .
CONCLUSIONS	Consequently , such a technique after a caesarean section can not be recommended .
BACKGROUND	ClinicalTrials.gov NCT01151943 .

###24585701
OBJECTIVE	The objective was to determine whether adding a self-regulatory intervention ( SRI ) focused on self-monitoring of spontaneous physical activity ( SPA ) and sedentary behavior to a standard weight loss intervention improved maintenance of lost weight .
METHODS	Older ( 65-79 years ) , obese ( BMI = 30-40 kg/m ( 2 ) ) adults ( n = 48 ) were randomized to a 5-month weight loss intervention involving a hypocaloric diet ( DIET ) and aerobic exercise ( EX ) with or without the SRI to promote SPA and decrease sedentary behavior ( SRI+DIET+EX compared with DIET+EX ) .
METHODS	Following the weight loss phase , both groups transitioned to self-selected diet and exercise behavior during a 5-month follow-up .
METHODS	Throughout the 10-months , the SRI+DIET+EX group utilized real-time accelerometer feedback for self-monitoring .
RESULTS	There was an overall group by time effect of the SRI ( P < 0.01 ) ; DIET+EX lost less weight and regained more weight than SRI+DIET+EX .
RESULTS	The average weight regain during follow-up was 1.3 kg less in the SRI+DIET+EX group .
RESULTS	Individuals in this group maintained approximately 10 % lower weight than baseline compared with those in the DIET+EX group whom maintained approximately 5 % lower weight than baseline .
CONCLUSIONS	Addition of a SRI , designed to increase SPA and decrease sedentary behavior , to a standard weight loss intervention enhanced successful maintenance of lost weight .

###24299932
BACKGROUND	Phenylephrine infusion is used to reduce hypotension during spinal anesthesia for cesarean delivery .
BACKGROUND	A prophylactic fixed rate infusion regimen may not improve hemodynamic control ; a variable rate regimen adjusted in response to changes in arterial blood pressure and heart rate may allow more accurate maintenance of baseline blood pressure .
BACKGROUND	We hypothesized that a combination of crystalloid solution coload with a variable rate phenylephrine infusion and phenylephrine rescue boluses may be associated with fewer physician interventions needed to maintain maternal systolic blood pressure within 20 % of baseline and greater hemodynamic stability than crystalloid solution coload with phenylephrine rescue boluses alone .
METHODS	In this prospective , double-blind study , 80 patients received a coload with 15 mL/kg lactated Ringer 's solution immediately after the initiation of spinal anesthesia .
METHODS	Patients were randomized to receive a prophylactic variable rate phenylephrine infusion starting at 0.75 g/kg/min ( group P ) or infusion of normal saline ( group S ) .
METHODS	Maternal systolic blood pressure was maintained within 20 % of baseline with rescue phenylephrine boluses using a preset algorithm .
METHODS	During the predelivery period , the number of physician interventions ( primary outcome ) , hemodynamic performance , nausea/vomiting , and umbilical cord blood gas values were compared between the groups .
RESULTS	One patient from group S was excluded due to protocol violation .
RESULTS	Therefore , group P included 40 patients and group S 39 patients .
RESULTS	The median ( range ) number of physician interventions needed to maintain maternal hemodynamics within the target range ( 0 [ 0-6 ] vs 3 [ 0-9 ] , difference in median : 3 , 95 % confidence interval of difference : 2-4 ) and incidence of hypotension ( 8/40 [ 20 % ] vs 35/39 [ 90 % ] ) were lower in group P compared with group S ( P < 0.001 ) .
RESULTS	Group P had a higher incidence of hypertension compared with group S ( 6/40 [ 15 % ] vs 0/39 [ 0 % ] , P = 0.026 ) .
RESULTS	The median performance error was closer to baseline ( P < 0.001 ) with a smaller median absolute performance error ( P = 0.001 ) in group P versus group S.
RESULTS	In group P , 4/40 ( 10 % ) patients had nausea/vomiting compared with 17/39 ( 44 % ) in group S ( P = 0.001 ) .
RESULTS	The number needed to treat was 1.4 women to prevent 1 case of hypotension , and 3 women to prevent 1 case of nausea/vomiting ; the rate of hypertension was 1 case per 6.7 women treated .
RESULTS	Neonatal outcomes were not different between the 2 groups .
CONCLUSIONS	Prophylactic variable rate phenylephrine infusion and rescue phenylephrine bolus dosing is more effective than relying on rescue phenylephrine bolus dosing with respect to limiting clinician workload and maternal symptoms during spinal anesthesia for cesarean delivery .

###24674853
OBJECTIVE	The aim of this study is to describe implementation of a randomized controlled trial of community-based participatory research ( CBPR ) approaches to increase park use and physical activity across 33 diverse neighborhoods in Los Angeles .
METHODS	Fifty parks were randomly assigned based on park size , facilities and programs , and neighborhood socio-demographic characteristics to : park director ( PD , 17 parks ) ; PD and park advisory board of interested community members ( PD+PAB , 16 parks ) ; and no-intervention control ( 17 parks ) arms .
METHODS	Between 2007 and 2012 , PDs and PABs from the 33 intervention parks participated in community engagement , baseline assessment , marketing training , intervention design and implementation , and follow-up assessment .
RESULTS	Intervention parks ( PD and PD+PAB ) invested in new and diversified signage , promotional items , outreach or support for group activities like fitness classes and walking clubs , and various marketing strategies .
RESULTS	Scaling up CBPR methods across parks in 33 diverse neighborhoods was challenging .
RESULTS	Working with departmental management and established structures for community input ( PABs ) and park policy ( PDs ) facilitated implementation and sustainability .
CONCLUSIONS	Scaling up CBPR methods across diverse communities involved tradeoffs .
CONCLUSIONS	CBPR is useful for tailoring research and enhancing community impact and sustainability , but more work is needed to understand how to conduct multi-site trials across diverse settings using CBPR .

###24384945
OBJECTIVE	Posterior-cruciate-ligament-retaining ( PCR ) and posterior-cruciate-ligament-stabilized ( PS ) arthroplasties are two major common practices in total knee arthroplasty ( TKA ) .
OBJECTIVE	The hypothesis of the present study was that compared with the PCR technique , the PS technique is associated with a higher amount of postoperative blood loss and greater need for blood transfusion in cemented TKA .
METHODS	In this prospective , randomized study , 100 patients diagnosed with primary knee osteoarthritis were randomly assigned to either the PCR group ( Group I ) or the PS group ( Group II ) .
METHODS	The exclusion criteria were rheumatological joint disease , previous knee surgery , anticoagulant therapy and hypertension .
METHODS	There were no significant differences in age , body mass index and gender , between the groups .
METHODS	The haemoglobin and haematocrit levels of each patient were recorded preoperatively and on postoperative days 1 , 3 and 5 .
METHODS	The postoperative suction drainage and blood transfusion volumes were also recorded .
RESULTS	There were no statistically significant differences in haemoglobin or haematocrit levels between the groups on postoperative days 1 , 3 and 5 .
RESULTS	There were also no statistically significant differences in the total measured blood loss volume , postoperative drainage amounts or transfusion rates between the groups .
CONCLUSIONS	Use of the PS technique during cemented TKA does not appear to influence the amount of perioperative blood loss or the need for postoperative blood transfusion in general .
CONCLUSIONS	The clinical relevance of this study is that the difference in blood loss between the PCR and PS techniques does not need to be considered by surgeons when performing TKA .

###24851943
BACKGROUND	Radical retropubic prostatectomy ( RRP ) is associated with an increased risk of intraoperative blood loss and the necessity of transfusions .
BACKGROUND	This prospective randomised clinical study evaluates the influence of thoracic epidural analgesia ( TEA ) on blood loss in RRP .
METHODS	235 patients were randomised : TEA in group 1 ( n = 116 ; general anaesthesia + TEA ) comprised continuous administration of 0.25 % bupivacaine , while group 2 ( n = 119 ; general anaesthesia alone ) received intravenous analgesia with fentanyl ( intubation : 2 g/kg ; maintenance : 0.1-0 .3 mg ) .
METHODS	A restrictive infusion regimen ( < 1,000 ml until specimen removal ) was administered in both groups .
METHODS	Blood loss , infusion rates and anaesthesiological parameters were recorded and analysed using regression models and analyses of variance .
RESULTS	Haemoglobin difference between the pre - and the first postoperative day ( group 1 : 3.35 1.16 g/dl ; group 2 : 3.56 1.42 g/dl ; p = 0.19 ) , overall blood loss ( group 1 : 665 431.5 ml ; group 2 : 705 881 ml ; p = 0.73 ) and transfusion rates ( 0.4 % intraoperatively ; 2.55 % postoperatively ; p = 1.0 ) did not show group differences .
RESULTS	In regression analysis blood loss was influenced by preoperative haemoglobin levels ( p < 0.0001 ) , patients ' weight ( p = 0.018 ) and duration of the operation ( p = 0.017 ) .
CONCLUSIONS	This study did not demonstrate a direct impact of TEA on intraoperative blood loss and transfusion rates in RRP .
CONCLUSIONS	Further randomised clinical trials are needed to evaluate an impact of the different anaesthetic procedures presented alone or in combination on blood loss .

###24806143
BACKGROUND	Currently , short-axis out-of-plane ( SA-OOP ) and long-axis in-plane ( LA-IP ) ultrasound techniques are used to guide radial artery cannulation .
BACKGROUND	In this study , we compared the success rate of a modified SA-OOP technique with that of traditional LA-IP .
METHODS	One hundred sixty-four patients who were to undergo liver surgery or splenic resection under general anesthesia were included .
METHODS	Using a sealed envelope method , patients were randomly divided into 2 groups : the modified SA-OOP or the LA-IP ultrasound guidance approaches .
METHODS	The number of cannula insertion attempts until success was recorded in both groups .
METHODS	The primary end point to compare the groups was the rate of cannula insertion successes on the first attempt .
METHODS	The secondary end points were also recorded and compared : insertion failure rate , inner diameter of the radial artery , depth of artery from the skin , ultrasonic location time , cannulation time , and vascular complications including thrombosis , hematoma , edema , and vasospasm .
RESULTS	The cannula insertion success rate on the first attempt was significantly higher in the modified SA-OOP group compared with the LA-IP group ( proportion difference 15.7 % , 95 % confidence interval [ CI ] , 0.6 % -30.7 % , P = 0.0158 ) .
RESULTS	However , the insertion failure rate was not different between groups ( 95 % CI , -17.7 % to 12.8 % , P = 0.4969 ) .
RESULTS	The ultrasonic location time was significantly decreased in the modified SA-OOP group compared with the LA-IP group ( mean difference -9.5 seconds , 95 % CI , -10.6 to -8.5 seconds , P < 0.0001 ) .
RESULTS	However , there was no significant difference between groups for cannulation time ( 95 % CI , -0.6 to 7.6 seconds , P = 0.1152 ) , depth of artery ( 95 % CI , -0.07 to 0.57 mm , P = 0.1050 ) , and the diameter of the radial artery ( 95 % CI , -0.30 to 0.03 mm , P = 0.1153 ) .
CONCLUSIONS	The modified SA-OOP technique may improve the success rate of cannula insertion into the radial artery on the first attempt .

###24516038
OBJECTIVE	Chemotherapy-induced diarrhea ( CID ) is a relatively common adverse event in the treatment of patients with colorectal cancer .
OBJECTIVE	The LAR for Chemotherapy-Induced Diarrhea ( LARCID ) trial evaluated the efficacy and safety of long-acting release octreotide ( octreotide LAR ) for the prevention of CID in this population .
METHODS	Patients with colorectal cancer starting adjuvant or first-line treatment with a chemotherapy combination containing fluorouracil , capecitabine , and/or irinotecan were randomly assigned to receive octreotide LAR 30 mg intramuscularly every 4 weeks ( experimental arm ) or the physician 's treatment of choice in case of diarrhea ( control arm ) .
RESULTS	A total of 139 patients were randomly assigned , most of whom received fluorouracil - and oxaliplatin-containing chemotherapy regimens .
RESULTS	The rate of diarrhea was 76.1 % in the experimental group ( n = 68 ) and 78.9 % in the control group ( n = 71 ) .
RESULTS	Treatment with octreotide LAR did not prevent or reduce the severity of CID .
RESULTS	Treatment choices for diarrhea management included loperamide in the majority of patients .
RESULTS	No benefit from octreotide LAR was identified in terms of need for diarrhea treatment , opioids , or intravenous hydration or in the rate of hospitalization or quality of life .
CONCLUSIONS	This study could not prove the efficacy of octreotide LAR in the prevention of CID .

###25675201
BACKGROUND	Treatment with rituximab may be accompanied by a systemic cytokine release .
BACKGROUND	We studied the effects of a single dose of rituximab on cytokine levels in transplant patients and examined the underlying mechanism .
METHODS	Twenty renal transplant recipients ( 10 rituximab-treated , 10 placebo-treated ) were recruited from a randomized clinical trial .
METHODS	Rituximab or placebo was infused during surgery , and blood samples were taken before , during , and after surgery and analyzed for interleukin ( IL ) -2 , IL-4 , IL-6 , IL-10 , IL-12 , IL-17 , interferon - , macrophage inflammatory protein ( MIP ) -1 , transforming growth factor - , and tumor necrosis factor - .
METHODS	in vitro , healthy donor peripheral blood mononuclear cells , purified B cells , monocytes , natural killer ( NK ) cells , or combinations thereof were incubated with rituximab , rituximab-F ( ab ' ) 2 , or medium and MIP-1 , IL-10 , interferon - , and tumor necrosis factor - levels were measured in the supernatant .
RESULTS	Rituximab-treated patients had higher serum levels of IL-10 ( 101 35 pg/mL vs 41 9 pg/mL ; P < 0.01 ) and MIP-1 ( 950 418 pg/mL vs 125 32 pg/mL ; P < 0.001 ) compared to placebo-treated patients at 2 hours after start of infusion .
RESULTS	There was no difference in the level of other cytokines .
RESULTS	In vitro , the addition of rituximab , but not rituximab-F ( ab ' ) 2 fragments , only led to significantly increased levels of MIP-1 in co-cultures of B and NK cells .
RESULTS	Levels of MIP-1 were higher in patients with a high affinity Fc-receptor compared to those with a lower affinity FcRIIIa ( 1356 184 pg/mL vs 679 273 pg/mL ; P < 0.01 ) .
CONCLUSIONS	In addition to B-cell depletion , rituximab can modulate the immune response by inducing cytokine secretion , especially IL-10 and MIP-1 .
CONCLUSIONS	Rituximab-induced MIP-1 secretion depends on the combined presence of B cells and FcR-bearing cells , especially NK cells .

###24402597
OBJECTIVE	To compare a new low-dose levonorgestrel and ethinyl estradiol contraceptive patch ( Patch ) with a combination oral contraceptive ( Pill ; 100 micrograms levonorgestrel , 20 micrograms ethinyl estradiol ) regarding efficacy , safety , compliance , and unscheduled uterine bleeding .
METHODS	Women ( 17-40 years ; body mass index 16-60 ) were randomized in a 3:1 ratio to one of two groups : Patch only ( 13 cycles ) or Pill ( six cycles ) followed by Patch ( seven cycles ) .
METHODS	Investigators evaluated adverse events during cycles 2 , 4 , 6 , 9 , and 13 .
METHODS	Participants recorded drug administration and uterine bleeding on daily diary cards .
METHODS	Compliance was assessed by measuring levonorgestrel and ethinyl estradiol plasma levels .
METHODS	Pearl Index ( pregnancies per 100 woman-years ) was calculated to evaluate efficacy .
RESULTS	Participants ( N = 1,504 ) were randomized to Patch ( n = 1,129 ) or Pill ( n = 375 ) .
RESULTS	Approximately 30 % were obese , more than 40 % were racial or ethnic minorities , and more than 55 % were new users of hormonal contraceptives .
RESULTS	Laboratory-verified noncompliance ( undetectable plasma drug levels ) was 11 % of Patch and 12.6 % of Pill users at cycle 6 .
RESULTS	Pearl Indices ( 95 % confidence intervals ) for the intention-to-treat population ( cycles 1-6 ) were 4.45 ( 2.34-6 .57 ) for Patch and 4.02 ( 0.50-7 .53 ) for Pill ; excluding laboratory-verified noncompliant participants , Pearl Indices were 2.82 ( 0.98-4 .67 ) for Patch and 3.80 ( 0.08-7 .52 ) for Pill ( differences not statistically significant ) .
RESULTS	Incidence of unscheduled bleeding and incidence and severity of adverse events were similar for both contraceptives ( no statistically significant difference ) .
CONCLUSIONS	Efficacy and safety of the new contraceptive Patch are comparable to those of a Pill .
CONCLUSIONS	Laboratory-verified noncompliance and bleeding profile are similar between the two treatments .
CONCLUSIONS	The Patch was well tolerated .
BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT01181479 .
METHODS	I.

###24916694
OBJECTIVE	Endocrine therapies include aromatase inhibitors and the selective estrogen receptor ( ER ) downregulator fulvestrant .
OBJECTIVE	This study aimed to determine whether the reported efficacy of fulvestrant over anastrozole , and high - over low-dose fulvestrant , reflect distinct transcriptional responses .
METHODS	Global gene expression profiles from ER-positive breast carcinomas before and during presurgical treatment with fulvestrant ( n = 22 ) or anastrozole ( n = 81 ) , and corresponding in vitro models , were compared .
METHODS	Transcripts responding differently to fulvestrant and estrogen deprivation were identified and integrated using Gene Ontology , pathway and network analyses to evaluate their potential significance .
RESULTS	The overall transcriptional response to fulvestrant and estrogen deprivation was correlated ( r = 0.61 in presurgical studies , r = 0.87 in vitro ) , involving downregulation of estrogen-regulated and proliferation-associated genes .
RESULTS	The transcriptional response to fulvestrant was of greater magnitude than estrogen deprivation ( slope = 0.62 in presurgical studies , slope = 0.63 in vitro ) .
RESULTS	Comparative analyses identified 28 genes and 40 Gene Ontology categories affected differentially by fulvestrant .
RESULTS	Seventeen fulvestrant-specific genes , including CAV1/2 , SNAI2 , and NRP1 , associated with ER , androgen receptor ( AR ) , and TP53 , in a network regulating cell cycle , death , survival , and tumor morphology .
RESULTS	Eighteen genes responding differently to fulvestrant specifically predicted antiproliferative response to fulvestrant , but not anastrozole .
RESULTS	Transcriptional effects of low-dose fulvestrant correlated with high-dose treatment , but were of lower magnitude ( ratio = 0.29 ) .
CONCLUSIONS	The transcriptional response to fulvestrant has much in common with estrogen deprivation , but is stronger with distinctions potentially attributable to arrest of estrogen-independent ER activity and involvement of AR signaling .
CONCLUSIONS	Genes responding differently to fulvestrant may have predictive utility .
CONCLUSIONS	These data are consistent with the clinical efficacy of fulvestrant versus anastrozole and higher dosing regimens .

###25325894
OBJECTIVE	To compare the impact of varying fluidic parameters on intraoperative intraocular pressure ( IOP ) fluctuations and postoperative outcomes .
METHODS	Prospective randomized study of 80 eyes undergoing cataract surgery that were randomly assigned to low ( aspiration flow rate : 20 cc/min ; bottle height : 90 cm ; vacuum : 400 mm Hg ) and high ( aspiration flow rate : 40 cc/min ; bottle height : 110 cm ; vacuum : 400 mm Hg ) fluidic parameter groups .
METHODS	Real-time dynamic intraoperative IOP was measured during nuclear fragment removal .
METHODS	Mean maximum and minimum IOP and percentage reduction in IOP from maximum were compared between groups .
METHODS	Postoperatively , the rate of change in central corneal thickness and anterior chamber inflammation at days 1 and 7 , endothelial cell density at 3 months , and corneal clarity on day 1 were compared .
RESULTS	Minimum IOP in the low and high parameters groups was 35 4.0 and 34.5 6.8 mm Hg , respectively .
RESULTS	Maximum IOP in the low and high parameters groups was 69 3.0 and 85 1.2 mm Hg , respectively ( P < .002 ) .
RESULTS	Mean percent reduction from maximum was 59 % in the high parameters group compared to 41 % in the low parameters group , with the difference being statistically significant ( P < .002 ) .
RESULTS	Rate of change in central corneal thickness was greater in the high parameters group at postoperative days 1 and 7 ( P < .001 ) .
RESULTS	Anterior chamber inflammation and corneal clarity on the first postoperative day were significantly better in the low parameters group .
CONCLUSIONS	Higher aspiration flow rate and bottle heights are associated with high intraoperative IOPs of up to 85 mm Hg .
CONCLUSIONS	Prolonged elevated IOP during cataract surgery was found to have more anterior segment inflammation and more edematous corneas .

###25464004
OBJECTIVE	We compare monopolar vs bipolar transurethral resection of the prostate in patients with benign prostatic hyperplasia , focusing on functional outcomes as well as rates of bleeding complications and the transurethral resection syndrome .
METHODS	A total of 137 patients with benign prostatic hyperplasia ( mean age 67 years , range 47 to 91 ) were prospectively randomly assigned to undergo monopolar ( 67 ) or bipolar ( 70 ) transurethral resection of the prostate .
METHODS	Patient characteristics of the 2 groups were similar .
METHODS	Hemoglobin ( as a marker of blood loss ) was measured preoperatively and perioperatively .
METHODS	I-PSS , I-PSS-QoL score , maximal flow rate and post-void residual urine volume were assessed preoperatively and 3 and 12 months postoperatively .
METHODS	Duration of surgery , indwelling catheter use and hospitalization were also documented , as were postoperative clot retention requiring removal by catheterization or surgery , and rates of bladder neck and/or urethral strictures .
RESULTS	No significant perioperative differences were found in duration of surgery , catheterization or hospitalization , or in blood loss or rates of blood transfusion and transurethral resection syndrome .
RESULTS	Postoperatively there were no significant differences in I-PSS or I-PSS-QoL scores , or rates of rehospitalization , clot retention , blood transfusions , reoperation or urethral strictures .
RESULTS	However , bladder neck stricture occurred significantly more often in the bipolar group ( 8.5 % vs 0 % , p = 0.02 ) .
RESULTS	The 3 and 12-month followup showed significant and equal improvement in micturition in the 2 groups .
CONCLUSIONS	Bipolar and monopolar transurethral resection of the prostate are effective and safe techniques for the surgical treatment of benign prostatic hyperplasia .
CONCLUSIONS	The only significant difference between them was a significantly higher rate of bladder neck strictures with bipolar resection of the prostate .

###24237728
OBJECTIVE	This study aimed ( 1 ) to determine whether scanner arm rotation causes significant movement of the head restraint and ( 2 ) to measure patient movement and its variation during the scan .
METHODS	The iCAT scanner and a high-speed camera were used .
METHODS	The 40 patients were divided into 2 groups : the open-eyed group and the blindfolded group .
RESULTS	The mean level of head restraint movement was 0.130 mm , with a significantly higher level at the beginning , probably owing to the accelerating arm .
RESULTS	Mean movement of patients was 1.135 mm and 1.119 mm in the open-eyed and blindfolded groups , respectively .
RESULTS	Patient movement was also significantly higher at the beginning of the scan , when noise and vibrations are likely to surprise the patient .
CONCLUSIONS	Patient instruction and a dry-run scan should be done by clinicians .
CONCLUSIONS	Manufacturers should consider separating the seat and head restraint from the rest of the scanner to avoid vibration transfer .

###24499441
BACKGROUND	The objective of this prospectively randomized phase II trial ( Trial registration : EUCTR2004-004007-37-DE ) was to compare the clinical response of primary breast cancer patients to neoadjuvant therapy with letrozole alone ( LET ) or letrozole and zoledronic acid ( LET + ZOL ) .
METHODS	Patients were randomly assigned to receive either LET 2.5 mg/day ( n = 79 ) or the combination of LET 2.5 mg/day and a total of seven infusions of ZOL 4 mg every 4 weeks ( n = 89 ) for 6 months .
METHODS	Primary endpoint was clinical response rate as assessed by mammogram readings .
METHODS	The study was terminated prematurely due to insufficient recruitment .
METHODS	We report here on an exploratory analysis of this data .
RESULTS	Central assessment of tumor sizes during the treatment period was available for 131 patients ( 66 LET , 65 LET + ZOL ) .
RESULTS	Clinical responses ( complete or partial ) were seen in 54.5 % ( 95 % CI : 41.8-66 .9 ) of the patients in the LET arm and 69.2 % ( 95 % CI : 56.6-80 .1 ) of those in the LET + ZOL arm ( P = 0.106 ) .
RESULTS	A multivariate model showed an OR of 1.72 ( 95 % CI : 0.83-3 .59 ) for the experimental arm .
CONCLUSIONS	No increase in the clinical response rate was observed with the addition of ZOL to a neoadjuvant treatment regimen with LET .
CONCLUSIONS	However a trend towards a better reponse in the LET + ZOL arm could be observed .
CONCLUSIONS	This trend is consistent with previous studies that have investigated the addition of ZOL to chemotherapy , and it may support the evidence for a direct antitumor action of zoledronic acid .

###24915838
OBJECTIVE	To evaluate the efficacy and safety of conversion to lacosamide 400 mg/day monotherapy in adults with focal epilepsy .
METHODS	This historical-controlled , double-blind study ( NCT00520741 ) enrolled patients aged 16-70 years on stable doses of 1-2 antiepileptic drugs ( AEDs ) and experiencing 2-40 partial-onset seizures per 28 days during the 8-week prospective Baseline .
METHODS	Patients were randomized to lacosamide 400 or 300 mg/day ( 3:1 ratio ) , starting at 200 mg/day and titrated over 3 weeks to randomized dose .
METHODS	Patients then withdrew background AEDs over 6 weeks and entered a 10-week Monotherapy Phase .
METHODS	The primary assessment was the Kaplan-Meier-predicted percentage of patients on 400 mg/day in the full analysis set ( FAS ) meeting 1 predefined seizure-related exit criterion by day 112 , compared with the historical-control threshold ( 65.3 % ) .
RESULTS	Four hundred twenty-five patients were enrolled and were eligible for safety analyses ( 400 mg/day , n = 319 ; 300 mg/day , n = 106 ) .
RESULTS	A total of 271 ( 63.8 % ) of 425 patients completed the Lacosamide Maintenance Phase ( combined AED Withdrawal and Monotherapy Phases ) .
RESULTS	Among 284 patients in the 400 mg/day group in the FAS , 82 ( 28.9 % ) met 1 exit criterion ; the Kaplan-Meier-predicted exit percentage at day 112 for 400 mg/day ( 30.0 % ; 95 % confidence interval [ CI ] 24.6-35 .5 % ) was lower than the historical control .
RESULTS	When exit events , withdrawal due to treatment-emergent adverse events ( TEAEs ) , and withdrawal due to lack of efficacy were summed ( n = 90 ) , the predicted exit percentage ( 32.3 % ; 95 % CI 26.8-37 .8 % ) was also lower than the historical control .
RESULTS	Most patients receiving 400 mg/day reported some improvement on the Clinical Global Impression of Change ( 75.4 % ) and Patient Global Impression of Change ( 74.3 % ) .
RESULTS	Overall , the most common ( > 10 % ) TEAEs were dizziness ( 24.0 % ) , headache ( 14.4 % ) , nausea ( 13.4 % ) , convulsion ( 11.5 % ) , somnolence ( 10.4 % ) , and fatigue ( 10.1 % ) ; most ( 74.1 % ) were mild-to-moderate in intensity .
RESULTS	Seventy-two patients ( 16.9 % ) discontinued due to TEAEs .
RESULTS	Seventeen patients ( 4 % , all receiving 400 mg/day ) experienced serious AEs .
CONCLUSIONS	Lacosamide 400 mg/day monotherapy was effective , with a favorable safety profile in patients with focal epilepsy .

###25291960
BACKGROUND	Prolonged sitting time is detrimental for health .
BACKGROUND	Individuals with desk-based occupations tend to sit a great deal and sit-stand workstations have been identified as a potential strategy to reduce sitting time .
BACKGROUND	Hence , the objective of the current study was to examine the effects of using sit-stand workstations on office workers ' sitting time at work and over the whole day .
METHODS	We conducted a randomized controlled trial pilot with crossover design and waiting list control in Sydney , Australia from September 2011 to July 2012 ( n = 42 ; 86 % female ; mean age 3811 years ) .
METHODS	Participants used a sit-stand workstation for four weeks in the intervention condition .
METHODS	In the time-matched control condition , participants received nothing and crossed over to the intervention condition after four weeks .
METHODS	The primary outcomes , sitting , standing and walking time at work , were assessed before and after using the workstations with ActivPALs and self-report questionnaires .
METHODS	Secondary outcomes , domain-specific sitting over the whole day , were assessed by self-report .
METHODS	Linear mixed models estimated changes in outcomes adjusting for measurement time , study grouping and covariates .
RESULTS	Intervention participants significantly reduced objectively assessed time spent sitting at work by 73 min/workday ( 95 % CI : -106 , -39 ) and increased standing time at work by 65 min/workday ( 95 % CI : 47 , 83 ) ; these changes were significant relative to controls ( p = 0.004 and p < 0.001 , respectively ) .
RESULTS	Total sitting time significantly declined in intervention participants ( -80 min/workday ; 95 % CI : -155 , -4 ) .
CONCLUSIONS	This study shows that introducing sit-stand workstations in the office can reduce desk-based workers ' sitting time at work in the short term .
CONCLUSIONS	Larger scale studies on more representative samples are needed to determine the public health impact of sit-stand workstations .
BACKGROUND	ACTRN12612000072819 .

###25552576
OBJECTIVE	To determine whether falls can be prevented with minimally supervised exercise targeting potentially remediable fall risk factors , i.e. , poor balance , reduced leg muscle strength , and freezing of gait , in people with Parkinson disease .
METHODS	Two hundred thirty-one people with Parkinson disease were randomized into exercise or usual-care control groups .
METHODS	Exercises were practiced for 40 to 60 minutes , 3 times weekly for 6 months .
METHODS	Primary outcomes were fall rates and proportion of fallers during the intervention period .
METHODS	Secondary outcomes were physical ( balance , mobility , freezing of gait , habitual physical activity ) , psychological ( fear of falling , affect ) , and quality-of-life measures .
RESULTS	There was no significant difference between groups in the rate of falls ( incidence rate ratio [ IRR ] = 0.73 , 95 % confidence interval [ CI ] 0.45-1 .17 , p = 0.18 ) or proportion of fallers ( p = 0.45 ) .
RESULTS	Preplanned subgroup analysis revealed a significant interaction for disease severity ( p < 0.001 ) .
RESULTS	In the lower disease severity subgroup , there were fewer falls in the exercise group compared with controls ( IRR = 0.31 , 95 % CI 0.15-0 .62 , p < 0.001 ) , while in the higher disease severity subgroup , there was a trend toward more falls in the exercise group ( IRR = 1.61 , 95 % CI 0.86-3 .03 , p = 0.13 ) .
RESULTS	Postintervention , the exercise group scored significantly ( p < 0.05 ) better than controls on the Short Physical Performance Battery , sit-to-stand , fear of falling , affect , and quality of life , after adjusting for baseline performance .
CONCLUSIONS	An exercise program targeting balance , leg strength , and freezing of gait did not reduce falls but improved physical and psychological health .
CONCLUSIONS	Falls were reduced in people with milder disease but not in those with more severe Parkinson disease .
METHODS	This study provides Class III evidence that for patients with Parkinson disease , a minimally supervised exercise program does not reduce fall risk .
METHODS	This study lacked the precision to exclude a moderate reduction or modest increase in fall risk from exercise .
BACKGROUND	Australian New Zealand Clinical Trials Registry ( ACTRN12608000303347 ) .

###24548114
OBJECTIVE	Platelet aggregation is enhanced in firefighters following short bouts of work in thermal protective clothing ( TPC ) .
OBJECTIVE	We sought to determine if aspirin therapy before and/or following exertion in TPC prevents platelet activation .
METHODS	In a double-blind , placebo-controlled study , 102 firefighters were randomized to receive daily therapy ( 81 mg aspirin or placebo ) for 14 days before and a single dose ( 325 mg aspirin or placebo ) following exercise in TPC resulting in four potential assignments : aspirin before and after exercise ( AA ) , placebo before and after exercise ( PP ) , aspirin before and placebo after exercise ( AP ) , and placebo before and aspirin after exercise ( PA ) .
METHODS	Platelet closure time ( PCT ) was measured with a platelet function analyzer before the 2-week treatment , after the 2 week treatment period , immediately after exercise , and 30 , 60 , and 90 minutes later .
RESULTS	Baseline PCT did not differ between groups .
RESULTS	PCT changed over time in all four groups ( p < 0.001 ) rising to a median of > 300 seconds [ IQR 99 , 300 ] in AA and > 300 [ 92 , 300 ] in AP prior to exercise .
RESULTS	Following exercise , median PCT decreased to in all groups .
RESULTS	Median PCT returned to > 300 seconds 30 minutes later in AA and AP and rose to 300 seconds in PA 60 minutes after exercise .
CONCLUSIONS	Daily aspirin therapy blunts platelet activation during exertional heat stress and single-dose aspirin therapy following exertional heat stress reduces platelet activation within 60 minutes .

###25458830
OBJECTIVE	Hyperglycemia improves when patients with type 2 diabetes are placed on a weight-loss diet .
OBJECTIVE	Improvement typically occurs soon after diet implementation .
OBJECTIVE	This rapid response could result from low fuel supply ( calories ) , lower carbohydrate content of the weight-loss diet , and/or weight loss per se .
OBJECTIVE	To differentiate these effects , glucose , insulin , C-peptide and glucagon were determined during the last 24 h of a 3-day period without food ( severe calorie restriction ) and a calorie-sufficient , carbohydrate-free diet .
METHODS	Seven subjects with untreated type 2 diabetes were studied .
METHODS	A randomized-crossover design with a 4-week washout period between arms was used .
METHODS	Results from both the calorie-sufficient , carbohydrate-free diet and the 3-day fast were compared with the initial standard diet consisting of 55 % carbohydrate , 15 % protein and 30 % fat .
RESULTS	The overnight fasting glucose concentration decreased from 196 ( standard diet ) to 160 ( carbohydrate-free diet ) to 127 mg/dl ( fasting ) .
RESULTS	The 24 h glucose and insulin area responses decreased by 35 % and 48 % on day 3 of the carbohydrate-free diet , and by 49 % and 69 % after fasting .
RESULTS	Overnight basal insulin and glucagon remained unchanged .
CONCLUSIONS	Short-term fasting dramatically lowered overnight fasting and 24 h integrated glucose concentrations .
CONCLUSIONS	Carbohydrate restriction per se could account for 71 % of the reduction .
CONCLUSIONS	Insulin could not entirely explain the glucose responses .
CONCLUSIONS	In the absence of carbohydrate , the net insulin response was 28 % of the standard diet .
CONCLUSIONS	Glucagon did not contribute to the metabolic adaptations observed .

###26132687
OBJECTIVE	Exposure therapy in anorexia nervosa has preliminarily been shown to be effective for increasing food intake .
OBJECTIVE	D-Cycloserine is a glutamatergic N-methyl-d-aspartate receptor agonist that has been shown to facilitate the benefits of exposure therapy for anxiety disorders by enhancing the emotional learning in the exposures ; therefore , we examined D-cycloserine-facilitation of exposure therapy to increase body mass index ( BMI ) in patients with anorexia nervosa .
METHODS	Participants ( N = 36 ) with anorexia nervosa ( diagnosed via DSM-IV ) were recruited from a partial hospitalization eating disorder clinic between February 2013 and November 2013 .
METHODS	Participants were randomly assigned to receive exposure therapy plus D-cycloserine ( n = 20 ) or placebo ( n = 16 ) .
METHODS	Participants completed psychoeducation and 4 sessions of exposure therapy , with medication ( D-cycloserine vs placebo ) given prior to the first 3 exposure sessions .
METHODS	They also completed a 1-month follow-up .
RESULTS	As hypothesized , participants in the D-cycloserine group showed a significantly greater increase in BMI than those in the placebo group ( Wilk = 0.86 , F3 ,32 = 2.20 , P = .043 , p ( 2 ) = 0.12 ) .
RESULTS	D-Cycloserine participants gained 3 pounds relative to 0.5 pounds in the placebo group .
RESULTS	Both groups experienced significantly decreased anxiety over the course of therapy ( Wilk = 0.80 , F3 ,32 = 3.32 , P = .023 , p ( 2 ) = 0.20 ) .
CONCLUSIONS	This study preliminarily demonstrates that D-cycloserine facilitates exposure therapy for anorexia nervosa , leading to increased weight gain .
CONCLUSIONS	A potential mechanism is that participants who receive D-cycloserine may generalize learning from within-session exposures to food intake during other similar meals , resulting in sustained increases in BMI .
CONCLUSIONS	Further research is needed to confirm these findings and test the putative mechanism that generalized learning from exposure therapy can increase BMI and stabilize a healthy weight .
BACKGROUND	ClinicalTrials.gov identifier : NCT01996644 .

###25190523
BACKGROUND	A fixed-ratio combination of the basal insulin analogue insulin degludec and the glucagon-like peptide-1 ( GLP-1 ) analogue liraglutide has been developed as a once-daily injection for the treatment of type 2 diabetes .
BACKGROUND	We aimed to compare combined insulin degludec-liraglutide ( IDegLira ) with its components given alone in insulin-naive patients .
METHODS	In this phase 3 , 26-week , open-label , randomised trial , adults with type 2 diabetes , HbA1c of 7-10 % ( inclusive ) , a BMI of 40 kg/m ( 2 ) or less , and treated with metformin with or without pioglitazone were randomly assigned ( 2:1:1 ) to daily injections of IDegLira , insulin degludec , or liraglutide ( 18 mg per day ) .
METHODS	IDegLira and insulin degludec were titrated to achieve a self-measured prebreakfast plasma glucose concentration of 4-5 mmol/L .
METHODS	The primary endpoint was change in HbA1c after 26 weeks of treatment , and the main objective was to assess the non-inferiority of IDegLira to insulin degludec ( with an upper 95 % CI margin of 03 % ) , and the superiority of IDegLira to liraglutide ( with a lower 95 % CI margin of 0 % ) .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01336023 .
RESULTS	1663 adults ( mean age 55 years [ SD 10 ] , HbA1c 83 % [ 09 ] , and BMI 312 kg/m ( 2 ) [ 48 ] ) were randomly assigned , 834 to IDegLira , 414 to insulin degludec , and 415 to liraglutide .
RESULTS	After 26 weeks , mean HbA1c had decreased by 19 % ( SD 11 ) to 64 % ( 10 ) with IDegLira , by 14 % ( 10 ) to 69 % ( 11 ) with insulin degludec , and by 13 % ( 11 ) to 70 % ( 12 ) with liraglutide .
RESULTS	IDegLira was non-inferior to insulin degludec ( estimated treatment difference -047 % , 95 % CI -058 to -036 , p < 00001 ) and superior to liraglutide ( -064 % , -075 to -053 , p < 00001 ) .
RESULTS	IDegLira was generally well tolerated ; fewer participants in the IDegLira group than in the liraglutide group reported gastrointestinal adverse events ( nausea 88 vs 197 % ) , although the insulin degludec group had the fewest participants with gastrointestinal adverse events ( nausea 36 % ) .
RESULTS	We noted no clinically relevant differences between treatments with respect to standard safety assessments , and the safety profile of IDegLira reflected those of its component parts .
RESULTS	The number of confirmed hypoglycaemic events per patient year was 18 for IDegLira , 02 for liraglutide , and 26 for insulin degludec .
RESULTS	Serious adverse events occurred in 19 ( 2 % ) of 825 patients in the IDegLira group , eight ( 2 % ) of 412 in the insulin degludec group , and 14 ( 3 % ) of 412 in the liraglutide group .
CONCLUSIONS	IDegLira combines the clinical advantages of basal insulin and GLP-1 receptor agonist treatment , resulting in improved glycaemic control compared with its components given alone .
BACKGROUND	Novo Nordisk .

###24906582
OBJECTIVE	This pilot study explores the feasibility of yoga as part of a treatment program for alcohol dependence .
METHODS	Eighteen alcohol dependent patients were randomized to receive either treatment as usual or treatment as usual plus yoga .
METHODS	Assessments were taken at baseline and six month follow-up .
METHODS	` Riddargatan 1 ' : an outpatient alcohol treatment clinic located in Stockholm , Sweden .
METHODS	Treatment as usual consisted of psychological and pharmacological interventions for alcohol dependence .
METHODS	The 10-week yoga intervention included a weekly group yoga session .
METHODS	Participants were encouraged to practice the yoga movements at home once per day .
METHODS	Alcohol consumption ( timeline follow-back method , DSM-IV criteria for alcohol dependence , and the Short Alcohol Dependence Data questionnaire ) , affective symptoms ( the Hospital Anxiety and Depression Scale ) , quality of life ( Sheehan Disability Scale ) and stress ( the Perceived Stress Scale and saliva cortisol ) .
RESULTS	Yoga was found to be a feasible and well accepted adjunct treatment for alcohol dependence .
RESULTS	Alcohol consumption reduced more in the treatment as usual plus yoga group ( from 6.32 to 3.36 drinks per day ) compared to the treatment as usual only group ( from 3.42 to 3.08 drinks per day ) .
RESULTS	The difference was , however , not statistically significant ( p = 0.17 ) .
CONCLUSIONS	Larger studies are needed to adequately assess the efficacy and long-term effectiveness of yoga as an adjunct treatment for alcohol dependence .

###25892647
BACKGROUND	The optimal timing of endocrine therapy in non-metastatic prostate cancer ( PCa ) is still an issue of debate .
METHODS	A randomised , double-blind , parallel-group trial comparing bicalutamide 150mg once daily with placebo in addition to standard care in patients with hormone-nave , non-metastatic PCa .
METHODS	Kaplan-Meier analysis was used to estimate overall survival ( OS ) and multivariate Cox proportional hazard model was performed to analyse time-to-event ( death ) .
RESULTS	A total of 1218 patients were included into the Scandinavian Prostate Cancer Group ( SPCG ) -6 study of which 607 were randomised to receive bicalutamide in addition to their standard care and 611 to receive placebo .
RESULTS	Median follow-up was 14.6 years .
RESULTS	Overall , 866 ( 71.1 % ) patients died , 428 ( 70.5 % ) in the bicalutamide arm and 438 ( 71.7 % ) in the placebo arm , p = 0.87 .
RESULTS	Bicalutamide significantly improved OS in patient with locally advanced disease ( hazard ratios ( HR ) = 0.77 ( 95 % confidence interval ( CI ) : 0.63-0 .94 , p = 0.01 ) , regardless of baseline prostate-specific antigen ( PSA ) , with a survival benefit which was apparent throughout the study period .
RESULTS	In contrast , survival favoured randomisation to the placebo arm in patients with localised disease ( HR = 1.19 ( 95 % CI : 1.00-1 .43 ) , p = 0.056 ) .
RESULTS	However , a survival gain from bicalutamide therapy was present in patients with localised disease and a baseline PSA greater than 28ng/mL at randomisation .
RESULTS	In multivariate Cox proportional hazard model , only including patients managed on watchful waiting as their standard of care ( n = 991 ) OS depended on age , World Health Organisation ( WHO ) grade , baseline PSA , clinical stage and randomised treatment .
CONCLUSIONS	Throughout the 14.6 year follow-up period the addition of early bicalutamide to standard of care resulted in a significant OS benefit in patients with locally advanced PCa .
CONCLUSIONS	In contrast , patients with localised PCa and low PSA derived no survival benefit from early bicalutamide .
CONCLUSIONS	The optimal timing for initiating bicalutamide in non-metastatic PCa patients is dependent on disease stage and baseline PSA .

###25145323
OBJECTIVE	Epidemiological studies suggest the existence of a relationship between aircraft noise exposure and increased risk for myocardial infarction and stroke .
OBJECTIVE	Patients with established coronary artery disease and endothelial dysfunction are known to have more future cardiovascular events .
OBJECTIVE	We therefore tested the effects of nocturnal aircraft noise on endothelial function in patients with or at high risk for coronary artery disease .
METHODS	60 Patients ( 50p 1-3 vessels disease ; 10p with a high Framingham Score of 23 % ) were exposed in random and blinded order to aircraft noise and no noise conditions .
METHODS	Noise was simulated in the patients ' bedroom and consisted of 60 events during one night .
METHODS	Polygraphy was recorded during study nights , endothelial function ( flow-mediated dilation of the brachial artery ) , questionnaires and blood sampling were performed on the morning after each study night .
RESULTS	The mean sound pressure levels L eq ( 3 ) measured were 46.9 2.0 dB ( A ) in the Noise 60 nights and 39.2 3.1 dB ( A ) in the control nights .
RESULTS	Subjective sleep quality was markedly reduced by noise from 5.8 2.0 to 3.7 2.2 ( p < 0.001 ) .
RESULTS	FMD was significantly reduced ( from 9.6 4.3 to 7.9 3.7 % ; p < 0.001 ) and systolic blood pressure was increased ( from 129.5 16.5 to 133.6 17.9 mmHg ; p = 0.030 ) by noise .
RESULTS	The adverse vascular effects of noise were independent from sleep quality and self-reported noise sensitivity .
CONCLUSIONS	Nighttime aircraft noise markedly impairs endothelial function in patients with or at risk for cardiovascular disease .
CONCLUSIONS	These vascular effects appear to be independent from annoyance and attitude towards noise and may explain in part the cardiovascular side effects of nighttime aircraft noise .

###24435069
BACKGROUND	Providing advice to wear good quality shoes with appropriate fit is one of the possibilities GPs have when treating patients with foot problems .
OBJECTIVE	The aims of this study are to ( i ) determine which shoe characteristics are important when providing shoe advice ; ( ii ) develop a shoe advice leaflet and ( iii ) evaluate if women choose better shoes with the aid of the leaflet .
METHODS	We performed a literature search on the effect of separate shoe characteristics on foot pathologies and kinematics and developed an information leaflet with the aid of multidisciplinary experts .
METHODS	The leaflet was tested in a group of women aged 50 years or over who did not receive podiatric treatment or shoe advice in the year prior to the study .
METHODS	The women were asked to select shoes ; half of them were provided with the leaflet .
METHODS	Shoe characteristics were scored blinded for the condition by two podiatrists .
METHODS	Data were analysed using a t-test for independent measures .
RESULTS	The developed leaflet contains nine shoe characteristics .
RESULTS	A total of 57 women ranging from 54 to 86 years old ( average 69 ) consented to participate in testing the efficacy of the leaflet .
RESULTS	Women using the leaflet ( n = 29 ) selected better shoes than without ( P = 0.049 ) .
CONCLUSIONS	Based on a literature search and expert opinion , we have developed an information leaflet for GPs to provide as a supplement to oral shoe advice .
CONCLUSIONS	Women using this leaflet were able to select shoes of better quality and better fit than women selecting shoes without using the leaflet .

###25668998
BACKGROUND	Ideal anesthetic technique for renal allograft recipients should provide hemodynamic stability , optimum graft reperfusion and adequate analgesia .
BACKGROUND	Balanced anesthesia is preferred because renal nociception is conducted multi-segmentally and chronically ill ESRD patients have labile psychological profile .
BACKGROUND	Present study compared the efficacy ofdexmedetomidine with fentanyl administered via intravenous and epidural route before induction of general anesthesia .
METHODS	Prospective , double blind randomized study , recruited sixty hemo-dynamically stable ESRD adults , 18-55 years , scheduled for elective live related renal transplantation .
METHODS	Patients randomly received intravenous dexmedetomidine 0.5 g/kg followed by epidural dexmedetomidine 0.5 g/kg alongwith 5 ml ; 0.25 % ropivacaine or intravenous fentanyl 1 g/kg followed by epiduralfentanyl 1 g/kg alongwith 5 ml ; 0.25 % ropivacaine .
METHODS	All patients received standardized general anaesthesia and continuous epidural ropivacaine 0.25 % ; 4-8 ml/hr .
METHODS	Preoperative sedation , peri-operative haemodynamics , end tidal anaesthetic agent requirement , peri-operative fluid requirement , need for vasopressors , blood loss and early graft function was assessed .
RESULTS	80 % patients receiving intravenous dexmedetomidine did not require rescue midazolam for achieving satisfactory sedation before induction of general anaesthesia .
RESULTS	Dexmedetomidine significantly reduced propofol and end tidal inhalational agents requirement and need for rescue analgesics .
RESULTS	Early renal graft function ( onset time of diuresis after declamping , 24 hours urine output and serum creatinine levels ) was comparable .
RESULTS	There were no adverse sequelae .
CONCLUSIONS	Dexmedetomidine-based anaesthetic regimen versus fentanyl-based anaesthesia provided appropriate anxiolysis and analgesia for conducting invasive procedures and subsequent epidural administration of these agents reduced anaesthetic requirement and prolonged postoperative analgesia without compromising hemodynamics and respiratory parameters .
CONCLUSIONS	Further dose finding studies can be conducted in kidney transplant recipients .

###24532106
BACKGROUND	The effect of the surgical site of DBS on balance and gait in Parkinson 's Disease ( PD ) is uncertain .
BACKGROUND	This is the first double-blind study of subjects randomized to either the STN ( N = 14 ) or GPi ( N = 14 ) who were assessed on a range of clinical balance measures .
METHODS	Balance testing occurred before and 6 months postsurgery .
METHODS	A control PD group was tested over the same period without surgery ( N = 9 ) .
METHODS	All subjects were tested on and off medication and DBS subjects were also tested on and off DBS .
METHODS	The Postural Instability and Gait Disability items of the UPDRS and additional functional tests , which we call the Balance and Gait scale , were assessed .
METHODS	Activities of Balance Confidence and Activities of Daily Living questionnaires were also recorded .
RESULTS	Balance was not different between the best-treated states before and after DBS surgery for both sites .
RESULTS	Switching DBS on improved balance scores , and scores further improved with medication , compared to the off state .
RESULTS	The GPi group showed improved performance in the postsurgery off state and better ratings of balance confidence after surgery , compared to the STN group .
CONCLUSIONS	Clinical measures of balance function for both the STN and GPi sites showed that balance did not improve beyond the best medically treated state before surgery .
CONCLUSIONS	Both clinical balance testing in the off/off state and self-reported balance confidence after surgery showed better performance in the GPi than the STN group .

###25103303
BACKGROUND	The scale-up of malaria rapid diagnostic tests ( RDTs ) is intended to improve case management of fever and targeting of artemisinin-based combination therapy .
BACKGROUND	Habitual presumptive treatment has hampered these intentions , suggesting a need for strategies to support behaviour change .
BACKGROUND	We aimed to assess the introduction of RDTs when packaged with basic or enhanced clinician training interventions in Cameroon .
METHODS	We did a three-arm , stratified , cluster-randomised trial at 46 public and mission health facilities at two study sites in Cameroon to compare three approaches to malaria diagnosis .
METHODS	Facilities were randomly assigned by a computer program in a 9:19:19 ratio to current practice with microscopy ( widely available , used as a control group ) ; RDTs with a basic ( 1 day ) clinician training intervention ; or RDTs with an enhanced ( 3 days ) clinician training intervention .
METHODS	Patients ( or their carers ) and fieldworkers who administered surveys to obtain outcome data were masked to study group assignment .
METHODS	The primary outcome was the proportion of patients treated in accordance with WHO malaria treatment guidelines , which is a composite indicator of whether patients were tested for malaria and given appropriate treatment consistent with the test result .
METHODS	All analyses were by intention to treat .
METHODS	This study is registered at ClinicalTrials.gov , number NCT01350752 .
RESULTS	The study took place between June 7 and Dec 14 , 2011 .
RESULTS	The analysis included 681 patients from nine facilities in the control group , 1632 patients from 18 facilities in the basic-training group , and 1669 from 19 facilities in the enhanced-training group .
RESULTS	The proportion of patients treated in accordance with malaria guidelines did not improve with either intervention ; the adjusted risk ratio ( RR ) for basic training compared with control was 104 ( 95 % CI 053-207 ; p = 090 ) , and for enhanced training compared with control was 117 ( 061-225 ; p = 062 ) .
RESULTS	Inappropriate use of antimalarial drugs after a negative test was reduced from 84 % ( 201/239 ) in the control group to 52 % ( 413/796 ) in the basic-training group ( unadjusted RR 063 , 028-143 ; p = 025 ) and to 31 % ( 232/759 ) in the enhanced-training group ( 029 , 011-077 ; p = 002 ) .
CONCLUSIONS	Enhanced clinician training , designed to translate knowledge into prescribing practice and improve quality of care , has the potential to halve overtreatment in public and mission health facilities in Cameroon .
CONCLUSIONS	Basic training is unlikely to be sufficient to support the behaviour change required for the introduction of RDTs .

###24865132
OBJECTIVE	To investigate individual patient data from a comprehensive trials programme to evaluate the safety and efficacy of the dipeptidyl peptidase-4 ( DPP-4 ) inhibitor linagliptin across a range of glucose-lowering regimens in a large elderly population with type 2 diabetes mellitus ( T2DM ) .
METHODS	Data were pooled from individuals aged 65 years , who participated in seven phase III , placebo-controlled clinical trials of linagliptin ( 24-52 weeks ) .
METHODS	Safety was assessed by incidence and severity of adverse events ( AEs ) with a focus on hypoglycaemia .
METHODS	The primary efficacy endpoint was change in glycated haemoglobin ( HbA1c ) .
RESULTS	In total , 841 subjects received linagliptin 5 mg once a day and 490 received placebo .
RESULTS	At baseline , the population had a mean s.d. age of 71.0 4.6 years and a mean HbA1c concentration of 8.0 0.8 % ; 63.5 % of subjects received 2 antidiabetes drugs .
RESULTS	Overall AEs and drug-related AEs were experienced by similar proportions of patients ( linagliptin 71.3 , placebo 73.3 ; linagliptin 18.1 , placebo 19.8 % , respectively ) .
RESULTS	The incidence of investigator-reported hypoglycaemia was 21.4 % with linagliptin and 25.7 % with placebo .
RESULTS	Severe hypoglycaemic events were rare and there were fewer in the linagliptin group ( 1.0 vs. 1.8 % ) .
RESULTS	At week 24 , the placebo-corrected adjusted mean s.e. reduction in HbA1c with linagliptin was -0.62 0.06 % ( 95 % CI : -0.73 , -0.51 ) .
CONCLUSIONS	Data from this large cohort show that linagliptin is a well-tolerated and efficacious therapy for elderly patients with T2DM .
CONCLUSIONS	Treatment with linagliptin may support individualized treatment goals , while effectively managing the risk of hypoglycaemia or drug-related side effects .

###24340029
BACKGROUND	We presented the pattern of health care consumption , and the utilization of available resources by describing the ecology of medical care in Beijing on a monthly basis and by describing the socio-demographic characteristics associated with receipt care in different settings .
METHODS	A cohort of 6,592 adults , 15 years of age and older were sampled to estimate the number of urban-resident adults per 1,000 who visited a medical facility at least once in a month , by the method of three-stage stratified and cluster random sampling .
METHODS	Separate logistic regression analyses assessed the association between those receiving care in different types of setting and their socio-demographic characteristics .
RESULTS	On average per 1,000 adults , 295 had at least one symptom , 217 considered seeking medical care , 173 consulted a physician , 129 visited western medical practitioners , 127 visited a hospital-based outpatient clinic , 78 visited traditional Chinese medical practitioners , 43 visited a primary care physician , 35 received care in an emergency department , 15 were hospitalized .
RESULTS	Health care seeking behaviors varied with socio-demographic characteristics , such as gender , age , ethnicity , resident census register , marital status , education , income , and health insurance status .
RESULTS	In term of primary care , the gate-keeping and referral roles of Community Health Centers have not yet been fully established in Beijing .
CONCLUSIONS	This study represents a first attempt to map the medical care ecology of Beijing urban population and provides timely baseline information for health care reform in China .

###24293660
BACKGROUND	Vitamin E ( VE ) bonded polysulfone dialysis membranes have putative erythropoiesis stimulating agent ( ESA ) - sparing and anti-inflammatory properties based on data from a small number of studies .
BACKGROUND	We sought to investigate this in a large , prospective 12-month randomized controlled trial .
METHODS	Two-hundred and sixty prevalent haemodialysis ( HD ) patients were randomized to dialysis with VE-bonded polysulfone membranes or non-VE-bonded equivalents .
METHODS	All ESA-dosing was performed by means of a computer-based anaemia management decision support system .
METHODS	Monthly data were used to calculate the ESA resistance index ( ERI ) and blood tests were performed at baseline , 6 and 12 months for measurement of C-reactive protein ( CRP ) levels .
RESULTS	Of the 260 patients , 123 were randomized to dialysis with the VE-membrane and 12-month data was available for 220 patients .
RESULTS	At the study population level , no beneficial effect of the VE membranes on the ERI or CRP levels was observed .
RESULTS	Post hoc analyses indicated that there was a significant fall in ERI for patients with the highest baseline ESA resistance dialysed with the VE ( 9.28 [ 7.70-12 .5 ] versus 7.70 [ 5.34-12 .7 ] IU/week/kg / g/dL Hb , P = 0.01 ) but not the control membranes ( 9.45 [ 7.62-12 .3 ] versus 8.14 [ 4.44-15 .6 ] IU/week/kg / g/dL Hb , P = 0.41 ) ; this was not attributable to changes in CRP levels .
CONCLUSIONS	Wholesale switching of all chronic HD patients to dialysis with VE-bonded polysulfone membranes appears not to be associated with improvements in ESA-responsiveness or CRP .
CONCLUSIONS	These membranes may have utility in patients with heightened ESA resistance .

###25304947
OBJECTIVE	Radiation Therapy Oncology Group ( RTOG ) 9508 showed a survival advantage for patients with 1 but not 2 or 3 brain metastasis ( BM ) treated with whole-brain radiation therapy ( WBRT ) and stereotactic radiosurgery ( SRS ) versus WBRT alone .
OBJECTIVE	An improved prognostic index , the graded prognostic assessment ( GPA ) has been developed .
OBJECTIVE	Our hypothesis was that if the data from RTOG 9508 were poststratified by the GPA , the conclusions may vary .
METHODS	In this analysis , 252 of the 331 patients were evaluable by GPA .
METHODS	Of those , 211 had lung cancer .
METHODS	Breast cancer patients were excluded because the components of the breast GPA are not in the RTOG database .
METHODS	Multiple Cox regression was used to compare survival between treatment groups , adjusting for GPA .
METHODS	Treatment comparisons within subgroups were performed with the log-rank test .
METHODS	A free online tool ( brainmetgpa.com ) simplified GPA use .
RESULTS	The fundamental conclusions of the primary analysis were confirmed in that there was no survival benefit overall for patients with 1 to 3 metastases ; however , there was a benefit for the subset of patients with GPA 3.5 to 4.0 ( median survival time [ MST ] for WBRT + SRS vs WBRT alone was 21.0 versus 10.3 months , P = .05 ) regardless of the number of metastases .
RESULTS	Among patients with GPA 3.5 to 4.0 treated with WBRT and SRS , the MST for patients with 1 versus 2 to 3 metastases was 21 and 14.1 months , respectively .
CONCLUSIONS	This secondary analysis of predominantly lung cancer patients , consistent with the original analysis , shows no survival advantage for the group overall when treated with WBRT and SRS ; however , in patients with high GPA ( 3.5-4 ) , there is a survival advantage regardless of whether they have 1 , 2 , or 3 BM .
CONCLUSIONS	This benefit did not extend to patients with lower GPA .
CONCLUSIONS	Prospective validation of this survival benefit for patients with multiple BM and high GPA when treated with WBRT and SRS is warranted .

###25240761
BACKGROUND	Drug development and clinical decision making for patients with metastatic prostate cancer ( PC ) have been hindered by a lack of quantitative methods of assessing changes in bony disease burden that are associated with overall survival ( OS ) .
BACKGROUND	Bone scan index ( BSI ) , a quantitative imaging biomarker of bone tumor burden , is prognostic in men with metastatic PC .
BACKGROUND	We evaluated an automated method for BSI calculation for the association between BSI over time with clinical outcomes in a randomized double-blind trial of tasquinimod ( TASQ ) in men with metastatic castration-resistant PC ( mCRPC ) .
METHODS	Bone scans collected during central review from the TASQ trial were analyzed retrospectively using EXINIbone ( BSI ) , an automated software package for BSI calculation .
METHODS	Associations between BSI and other prognostic biomarkers , progression-free survival , OS , and treatment were evaluated over time .
RESULTS	Of 201 men ( 57 TASQ and 28 placebo ) , 85 contributed scans at baseline and week 12 of sufficient quality .
RESULTS	Baseline BSI correlated with prostate-specific antigen and alkaline phosphatase levels and was associated with OS in univariate ( hazard ratio [ HR ] = 1.42 , P = 0.013 ) and multivariate ( HR = 1.64 , P < 0.001 ) analyses .
RESULTS	BSI worsening at 12 weeks was prognostic for progression-free survival ( HR = 2.14 per BSI doubling , P < 0.001 ) and OS ( HR = 1.58 , P = 0.033 ) in multivariate analyses including baseline BSI and TASQ treatment .
RESULTS	TASQ delayed BSI progression .
CONCLUSIONS	BSI and BSI changes over time were independently associated with OS in men with mCRPC .
CONCLUSIONS	A delay in objective radiographic bone scan progression with TASQ is suggested ; prospective evaluation of BSI progression and response criteria in phase 3 trials of men with mCRPC is warranted .

###24344672
BACKGROUND	Mortality following hip hemiarthroplasty is in the range of 10-40 % in the first year , with much attributed to post-operative complications .
BACKGROUND	One such complication is surgical site infection ( SSI ) , which at the start of this trial affected 4.68 % of patients in the UK having this operation .
BACKGROUND	Compared to SSI rates of elective hip surgery , at less than 1 % , this figure is elevated .
BACKGROUND	The aim of this quasi randomised controlled trial ( RCT ) is to determine if high dose antibiotic impregnated cement can reduce the SSI in patients at 12-months after hemiarthroplasty for intracapsular fractured neck of femur .
METHODS	848 patients with an intracapsular fractured neck of femur requiring a hip hemiarthroplasty are been recruited into this two-centre double-blind quasi RCT .
METHODS	Participants were recruited before surgery and quasi randomised to standard care or intervention group .
METHODS	Participants , statistician and outcome assessors were blind to treatment allocation throughout the study .
METHODS	The intervention consisted of high dose antibiotic impregnated cement consisting of 1 gram Clindamycin and 1 gram of Gentamicin .
METHODS	The primary outcome is Health Protection Agency ( HPA ) defined deep surgical site infection at 12 months .
METHODS	Secondary outcomes include HPA defined superficial surgical site infection at 30 days , 30 and 90-day mortality , length of hospital stay , critical care stay , and complications .
CONCLUSIONS	Large randomised controlled trials assessing the effectiveness of a surgical intervention are uncommon , particularly in the speciality of orthopaedics .
CONCLUSIONS	The results from this trial will inform evidence-based recommendations for antibiotic impregnated cement in the management of patients with a fractured neck of femur undergoing a hip hemiarthroplasty .
CONCLUSIONS	If high dose antibiotic impregnated cement is found to be an effective intervention , implementation into clinical practice could improve long-term outcomes for patients undergoing hip hemiarthroplasty .
BACKGROUND	Current Controlled Trials : ISRCTN25633145 .

###24499763
OBJECTIVE	To examine the influence of mechanical bowel preparation on surgical field visualization during laparoscopic hysterectomy .
METHODS	The study 's primary outcome was the percentage of operations rated `` good '' or `` excellent '' in terms of surgical field visualization at the outset of the case by the primary surgeon .
METHODS	Additional measures included assessment of visualization during the case and patient perioperative comfort .
METHODS	The study was powered to detect a 20 % absolute difference in the proportion of cases rated as `` good '' or `` excellent . ''
RESULTS	Seventy-three patients were assigned to mechanical bowel preparation and 73 to no mechanical bowel preparation .
RESULTS	The groups were comparable regarding patient and surgery characteristics .
RESULTS	No differences were found for this rating between groups ( mechanical bowel preparation , 64 of 73 patients [ 87.7 % ] , compared with no mechanical bowel preparation , 60 of 73 patients [ 82.2 % ] , P = .36 ) .
RESULTS	Surgeons guessed patient assignment correctly 59 % of the time ( 42 of 71 patients ) with mechanical bowel preparation and 55 % of the time ( 41 of 75 patients ) with no mechanical bowel preparation .
CONCLUSIONS	Mechanical bowel preparation is well-tolerated but does not influence surgical field visualization for laparoscopic hysterectomy .
BACKGROUND	ClinialTrials.gov , www.clinicaltrials.gov , NCT01576965 .

###24799467
OBJECTIVE	Idiotypes ( Ids ) , the unique portions of tumor immunoglobulins , can serve as targets for passive and active immunotherapies for lymphoma .
OBJECTIVE	We performed a multicenter , randomized trial comparing a specific vaccine ( MyVax ) , comprising Id chemically coupled to keyhole limpet hemocyanin ( KLH ) plus granulocyte macrophage colony-stimulating factor ( GM-CSF ) to a control immunotherapy with KLH plus GM-CSF .
METHODS	Patients with previously untreated advanced-stage follicular lymphoma ( FL ) received eight cycles of chemotherapy with cyclophosphamide , vincristine , and prednisone .
METHODS	Those achieving sustained partial or complete remission ( n = 287 [ 44 % ] ) were randomly assigned at a ratio of 2:1 to receive one injection per month for 7 months of MyVax or control immunotherapy .
METHODS	Anti-Id antibody responses ( humoral immune responses [ IRs ] ) were measured before each immunization .
METHODS	The primary end point was progression-free survival ( PFS ) .
METHODS	Secondary end points included IR and time to subsequent antilymphoma therapy .
RESULTS	At a median follow-up of 58 months , no significant difference was observed in either PFS or time to next therapy between the two arms .
RESULTS	In the MyVax group ( n = 195 ) , anti-Id IRs were observed in 41 % of patients , with a median PFS of 40 months , significantly exceeding the median PFS observed in patients without such Id-induced IRs and in those receiving control immunotherapy .
CONCLUSIONS	This trial failed to demonstrate clinical benefit of specific immunotherapy .
CONCLUSIONS	The subset of vaccinated patients mounting specific anti-Id responses had superior outcomes .
CONCLUSIONS	Whether this reflects a therapeutic benefit or is a marker for more favorable underlying prognosis requires further study .

###25481791
BACKGROUND	The poly ( ADP-ribose ) polymerase inhibitor olaparib has shown antitumour activity in patients with platinum-sensitive , recurrent , high-grade serous ovarian cancer with or without BRCA1 or BRCA2 mutations .
BACKGROUND	The aim of this study was to assess the efficacy and tolerability of olaparib in combination with chemotherapy , followed by olaparib maintenance monotherapy , versus chemotherapy alone in patients with platinum-sensitive , recurrent , high-grade serous ovarian cancer .
METHODS	In this randomised , open-label , phase 2 study , adult patients with platinum-sensitive , recurrent , high-grade serous ovarian cancer who had received up to three previous courses of platinum-based chemotherapy and who were progression free for at least 6 months before randomisation received either olaparib ( 200 mg capsules twice daily , administered orally on days 1-10 of each 21-day cycle ) plus paclitaxel ( 175 mg/m ( 2 ) , administered intravenously on day 1 ) and carboplatin ( area under the curve [ AUC ] 4 mg/mL per min , according to the Calvert formula , administered intravenously on day 1 ) , then olaparib monotherapy ( 400 mg capsules twice daily , given continuously ) until progression ( the olaparib plus chemotherapy group ) , or paclitaxel ( 175 mg/m ( 2 ) on day 1 ) and carboplatin ( AUC 6 mg/mL per min on day 1 ) then no further treatment ( the chemotherapy alone group ) .
METHODS	Randomisation was done by an interactive voice response system , stratified by number of previous platinum-containing regimens received and time to disease progression after the previous platinum regimen .
METHODS	The primary endpoint was progression-free survival according to Response Evaluation Criteria in Solid Tumors version 1.1 , analysed by intention to treat .
METHODS	Prespecified exploratory analyses included efficacy by BRCA mutation status , assessed retrospectively .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01081951 , and has been completed .
RESULTS	Between Feb 12 and July 30 , 2010 , 173 patients at 43 investigational sites in 12 countries were enrolled into the study , of whom 162 were eligible and were randomly assigned to the two treatment groups ( 81 to the olaparib plus chemotherapy group and 81 to the chemotherapy alone group ) .
RESULTS	Of these randomised patients , 156 were treated in the combination phase ( 81 in the olaparib plus chemotherapy group and 75 in the chemotherapy alone group ) and 121 continued to the maintenance or no further treatment phase ( 66 in the olaparib plus chemotherapy group and 55 in the chemotherapy alone group ) .
RESULTS	BRCA mutation status was known for 107 patients ( either at baseline or determined retrospectively ) : 41 ( 38 % ) of 107 had a BRCA mutation ( 20 in the olaparib plus chemotherapy group and 21 in the chemotherapy alone group ) .
RESULTS	Progression-free survival was significantly longer in the olaparib plus chemotherapy group ( median 12.2 months [ 95 % CI 9.7-15 .0 ] ) than in the chemotherapy alone group ( median 9.6 months [ 95 % CI 9.1-9 .7 ) ( HR 0.51 [ 95 % CI 0.34-0 .77 ] ; p = 0.0012 ) , especially in patients with BRCA mutations ( HR 0.21 [ 0.08-0 .55 ] ; p = 0.0015 ) .
RESULTS	In the combination phase , adverse events that were reported at least 10 % more frequently with olaparib plus chemotherapy than with chemotherapy alone were alopecia ( 60 [ 74 % ] of 81 vs 44 [ 59 % ] of 75 ) , nausea ( 56 [ 69 % ] vs 43 [ 57 % ] ) , neutropenia ( 40 [ 49 % ] vs 29 [ 39 % ] ) , diarrhoea ( 34 [ 42 % ] vs 20 [ 27 % ] ) , headache ( 27 [ 33 % ] vs seven [ 9 % ] ) , peripheral neuropathy ( 25 [ 31 % ] vs 14 [ 19 % ] ) , and dyspepsia ( 21 [ 26 % ] vs 9 [ 12 % ] ) ; most were of mild-to-moderate intensity .
RESULTS	The most common grade 3 or higher adverse events during the combination phase were neutropenia ( in 35 [ 43 % ] of 81 patients in the olaparib plus chemotherapy group vs 26 [ 35 % ] of 75 in the chemotherapy alone group ) and anaemia ( seven [ 9 % ] vs five [ 7 % ] ) .
RESULTS	Serious adverse events were reported in 12 ( 15 % ) of 81 patients in the olaparib plus chemotherapy group and 16 of 75 ( 21 % ) patients in the chemotherapy alone group .
CONCLUSIONS	Olaparib plus paclitaxel and carboplatin followed by maintenance monotherapy significantly improved progression-free survival versus paclitaxel plus carboplatin alone , with the greatest clinical benefit in BRCA-mutated patients , and had an acceptable and manageable tolerability profile .
BACKGROUND	AstraZeneca .

###24449682
BACKGROUND	Budesonide is a potent corticosteroid commonly prescribed for management of inflammation in chronic rhinosinusitis ( CRS ) .
BACKGROUND	The standard for prescribing budesonide is via impregnated nasal saline irrigation ( INSI ) , although recently the mucosal atomization device ( MAD ) has emerged as a theoretically superior method of distributing medication into the sinuses .
BACKGROUND	The MAD atomizes medication into small droplets and this is thought to enhance absorption and improve bioavailability .
BACKGROUND	However , no studies have shown whether enhanced absorption and improved bioavailability of budesonide via MAD causes adrenal suppression .
BACKGROUND	The objective of this study is to determine whether budesonide via MAD affects the hypothalamic-pituitary-adrenal ( HPA ) axis .
METHODS	Twenty CRS patients were recruited from a tertiary rhinology clinic and randomized to take budesonide ( 1 mg ) via MAD or via INSI twice a day for 60 days .
METHODS	The adrenocorticotropic hormone ( ACTH ) stimulation test and 22-item Sinonasal Outcomes Test ( SNOT-22 ) questionnaire were administered on days 1 , 30 , and 60 of the study .
METHODS	Plasma budesonide and cortisol levels were simultaneously quantified using a high-performance liquid chromatography-tandem mass spectrometry technique .
RESULTS	There was no indication of adrenal suppression in either group ( n = 20 ) based on ACTH stimulation test results nor was there significant plasma budesonide levels detected in either group .
RESULTS	Quality of life , as indicated by SNOT-22 , did not differ between groups at 60 days ( p = 0.404 ; 95 % confidence interval [ CI ] , -37.2 to 15.9 ) , but SNOT-22 scores for patients using MAD did show statistically significant improvement at 60 days compared to baseline ( p = 0.02 ) .
CONCLUSIONS	The MAD is likely a safe and effective method of delivering budesonide to the sinuses in the short term .

###25453534
OBJECTIVE	The purpose of this study was to investigate the predictive values of baseline and changes in cystatin C ( CysC ) and its derived equations for short-term adverse outcomes and the effect of nesiritide therapy on CysC in acute decompensated heart failure ( ADHF ) .
BACKGROUND	Newer renal biomarkers or their derived estimates of renal function have demonstrated long-term prognostic value in chronic heart failure .
METHODS	CysC levels were measured in sequential plasma samples from 811 subjects with ADHF who were enrolled in the ASCEND-HF ( Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure ) biomarker sub-study ( randomized to nesiritide therapy vs. placebo ) , and followed for all-cause death ( 180 days ) and recurrent hospital stay ( 30 days ) .
RESULTS	Median CysC levels were 1.49 ( interquartile range [ IQR ] : 1.20 to 1.96 ) mg/l at baseline , 1.56 ( IQR : 1.28 to 2.13 ) mg/l at 48 to 72 h , and 1.58 ( IQR : 1.24 to 2.11 ) mg/l at 30 days .
RESULTS	Higher baseline ( but not follow-up ) CysC levels were associated with increased risk of 30-day adverse events and less improvement in dyspnea after 24 h as well as 180-day mortality , although not incremental to blood urea nitrogen .
RESULTS	Worsening renal function ( defined as a 0.3 mg/l increase in CysC ) occurred in 161 of 701 ( 23 % ) patients , but it was not predictive of adverse events .
RESULTS	Changes in CysC levels were similar between the nesiritide and placebo groups .
CONCLUSIONS	Our findings confirmed the prognostic value of baseline CysC levels in the setting of ADHF .
CONCLUSIONS	However , worsening renal function based on CysC rise was not predictive of adverse events .
CONCLUSIONS	Nesiritide did not worsen renal function compared with placebo .

###25515698
BACKGROUND	Pharmacokinetic ( PK ) and pharmacodynamic ( PD ) data are limited for artesunate ( AS ) and amodiaquine ( AQ ) in uncomplicated Plasmodium falciparum .
METHODS	From 2007-8 , 54 P. falciparum-infected , Kenyan adults were assigned randomly fixed dose ( FD ) ASAQ ( n = 26 ) or non-fixed ( NF ) ASAQ ( n = 28 ) .
METHODS	Total doses were 600 mg AS ( both arms ) + 1,620 mg ( FD ) or 1,836 mg ( NF ) AQ .
METHODS	Follow-up extended over 28 days .
METHODS	PK data were collected for AS , dihydroartemisinin ( DHA ) , AS + DHA combined as DHA equivalents ( DHAeq ) , AQ , desethylamodiaquine ( DAQ ) , and their relationships assessed against the PD collected data consisting of parasitological efficacy , adverse events ( AEs ) , and the Bazett 's corrected QTinterval ( QTcB ) .
RESULTS	Mean AUC 0-72 of dihydroartemisinin equivalents ( DHAeq ) when administered as a fixed dose ( FD ) compared to NF dose were similar : 24.2 4.6 vs 26.46.9 mol * h/L ( p = 0.68 ) Parasite clearance rates were also similar after 24 hrs : 17/25 ( 68 % ) vs 18/28 ( 64.3 % ) ( p = 0.86 ) , as well as at 48 hrs : 25/8 ( 100 % ) vs 26 ( 92.9 % ) / 28 ( p = 0.49 ) .
RESULTS	Mean FD vs NF DAQ AUC0-28 were 27.63.19 vs 32.75.53 mg * h/L ( p = 0.0005 ) .
RESULTS	Two PCR-proven new infections occurred on Day ( D ) 28 for estimated , in vivo , DAQ minimum inhibitory concentrations of 15.2 and 27.5 ng/mL .
RESULTS	Combining the FD and NF arms , the mean QTcB at D2 +4 hrs increased significantly ( p = 0.0059 ) vs baseline : 420 vs410 ms ( = 9.02 ( 95 % confidence interval 2.72-15 .31 ms ) , explained by falling heart rates , increasing DAQ concentrations and female sex in a general linear mixed effects model .
RESULTS	Ten of 108 ( 9.26 % ) AEs ( 5/arm ) reported by 37/54 ( 68.5 % ) patients were possibly or probably drug related .
RESULTS	Severe , asymptomatic neutropaenia developed in 2/47 ( 4.25 % ) patients on D28 : 574/L ( vsD0 : 5,075 / L ) , and 777/L ( vsD0 : 3,778 / L ) .
CONCLUSIONS	Tolerability of both formulations was good .
CONCLUSIONS	For QTcB , a parameter for ECG modifications , increases were modest and due to rising DAQ concentrations and falling heart rates as malaria resolved .
CONCLUSIONS	Rapid parasite clearance rates and no resistant infections suggest effective pharmacokinetics of both formulations .

###25757810
OBJECTIVE	To compare the operative outcomes of patients undergoing either single-port or multiport laparoscopic hysterectomy ( LH ) .
METHODS	Two hundred fifty-six women scheduled for LH for symptomatic myoma and/or adenomyosis from 8 tertiary teaching hospitals were randomized to single-port or multiport groups .
METHODS	Primary outcome was conversion and/or complication proportion of the planned procedure to determine whether the success proportion of the single-port approach was not inferior to that of the multiport approach .
METHODS	Secondary outcomes were postoperative pain and operative scar .
RESULTS	Demographic parameters including age , body mass index , parity , and history of vaginal and cesarean delivery were comparable between the 2 groups .
RESULTS	The primary outcome of a combined conversion and/or complication rate was similar between the single-port and multiport groups at 8 % and 10.3 % , respectively .
RESULTS	Conversions were similar between the groups with 4 % of single-port cases and .8 % of multiport cases .
RESULTS	Transfusions were the most frequent complication required in 4.0 % of single-port cases and 7.9 % of multiport cases , with no difference between the groups .
RESULTS	Concerning secondary outcomes , postoperative pain score and patient and observer scar assessment were not different between the 2 groups .
RESULTS	Although not a specific outcome measure , there was no difference between the groups in blood loss , operative time , and postoperative hospital stay .
CONCLUSIONS	Single-port LH is not inferior to multiport LH in terms of conversion and/or complications rates , including transfusion .
CONCLUSIONS	However , the single-port approach did not have any advantage over multiport LH with regard to pain or cosmetic outcomes .
CONCLUSIONS	These findings were demonstrated by multi-institutional surgeons in Korea .

###24628950
BACKGROUND	In Europe , gastric cancer remains diagnosed at advanced stage ( serosal and/or lymph node involvement ) .
BACKGROUND	Despite curative management combining perioperative systemic chemotherapy and gastrectomy with D1-D2 lymph node dissection , 5-year survival rates of T3 and/or N + patients remain under 30 % .
BACKGROUND	More than 50 % of recurrences are peritoneal and/or locoregional .
BACKGROUND	The use of adjuvant hyperthermic intraperitoneal chemotherapy that eliminates free cancer cells that can be released into peritoneal cavity during the gastrectomy and prevents peritoneal carcinomatosis recurrences , was extensively evaluated by several randomized trials conducted in Asia .
BACKGROUND	Two meta-analysis reported that adjuvant hyperthermic intraperitoneal chemotherapy significantly reduces the peritoneal recurrences and significantly improves the overall survival .
BACKGROUND	As it was previously done for the evaluation of the extension of lymph node dissection , it seems very important to validate on European or caucasian patients the results observed in trials performed in Asia .
METHODS	GASTRICHIP is a prospective , open , randomized multicenter phase III clinical study with two arms that aims to evaluate the effects of hyperthermic intraperitoneal chemotherapy with oxaliplatin on patients with gastric cancer involving the serosa and/or lymph node involvement and/or with positive cytology at peritoneal washing , treated with perioperative systemic chemotherapy and D1-D2 curative gastrectomy .
METHODS	Peroperatively , at the end of curative surgery , patients will be randomized after preoperatively written consent has been given for participation .
METHODS	Primary endpoint will be overall survival from the date of surgery to the date of death or to the end of follow-up ( 5 years ) .
METHODS	Secondary endpoint will be 3 - and 5-year recurrence-free survival , site of recurrence , morbidity , and quality of life .
METHODS	An ancillary study will compare the incidence of positive peritoneal cytology pre - and post-gastrectomy in two arms of the study , and assess its impact on 5-year survival .
METHODS	The number of patients to be randomized was calculated to be 306 .
BACKGROUND	EudraCT number : 2012-005748-12 , ClinicalTrials.gov identifier : NCT01882933 .

###25448925
OBJECTIVE	Transoral esophagogastric fundoplication ( TF ) can decrease or eliminate features of gastroesophageal reflux disease ( GERD ) in some patients whose symptoms persist despite proton pump inhibitor ( PPI ) therapy .
OBJECTIVE	We performed a prospective , sham-controlled trial to determine if TF reduced troublesome regurgitation to a greater extent than PPIs in patients with GERD .
METHODS	We screened 696 patients with troublesome regurgitation despite daily PPI use with 3 validated GERD-specific symptom scales , on and off PPIs .
METHODS	Those with at least troublesome regurgitation ( based on the Montreal definition ) on PPIs underwent barium swallow , esophagogastroduodenoscopy , 48-hour esophageal pH monitoring ( off PPIs ) , and high-resolution esophageal manometry analyses .
METHODS	Patients with GERD and hiatal hernias 2 cm were randomly assigned to groups that underwent TF and then received 6 months of placebo ( n = 87 ) , or sham surgery and 6 months of once - or twice-daily omeprazole ( controls , n = 42 ) .
METHODS	Patients were blinded to therapy during follow-up period and reassessed at 2 , 12 , and 26 weeks .
METHODS	At 6 months , patients underwent 48-hour esophageal pH monitoring and esophagogastroduodenoscopy .
RESULTS	By intention-to-treat analysis , TF eliminated troublesome regurgitation in a larger proportion of patients ( 67 % ) than PPIs ( 45 % ) ( P = .023 ) .
RESULTS	A larger proportion of controls had no response at 3 months ( 36 % ) than subjects that received TF ( 11 % ; P = .004 ) .
RESULTS	Control of esophageal pH improved after TF ( mean 9.3 % before and 6.3 % after ; P < .001 ) , but not after sham surgery ( mean 8.6 % before and 8.9 % after ) .
RESULTS	Subjects from both groups who completed the protocol had similar reductions in GERD symptom scores .
RESULTS	Severe complications were rare ( 3 subjects receiving TF and 1 receiving the sham surgery ) .
CONCLUSIONS	TF was an effective treatment for patients with GERD symptoms , particularly in those with persistent regurgitation despite PPI therapy , based on evaluation 6 months after the procedure .
CONCLUSIONS	Clinicaltrials.gov no : NCT01136980 .

###24958585
OBJECTIVE	To compare 2 short-term , community caregiver training interventions for preschool-aged children with Autism Spectrum Disorder who had low resources .
OBJECTIVE	Low resource was defined by the US Department of Housing and Urban Development low-income index or 1 `` indicator , '' ( e.g. , Medicaid eligibility ) .
OBJECTIVE	Child outcomes focused on joint engagement , joint attention , and play .
METHODS	Participants included 112 families of a child who had Autism Spectrum Disorder who met criteria for being low-resourced and who were randomly assigned to 1 of 2 3-month interventions , group caregiver education or individualized caregiver-mediated intervention ( CMM ) .
METHODS	Children were assessed for social communication skills pre - and post-treatment , and followed up at 3 months .
RESULTS	All children improved in joint engagement and initiating joint attention , with significantly greater improvement by the CMM group .
RESULTS	Outcomes on play skills were mixed , with improvement of symbolic play for the CMM group and no change in functional play skills .
RESULTS	Joint engagement maintained over time for the CMM group , and initiating joint attention maintained for both groups over time .
CONCLUSIONS	This study is among the first randomized trials comparing 2 active interventions with a large sample of low-resourced families .
CONCLUSIONS	Results suggest improvements in core autism deficits of joint engagement , joint attention , and symbolic play with relatively brief , caregiver-mediated interventions , but additional support is necessary to maintain and generalize these gains over time .

###24923987
BACKGROUND	Appetitive and aversive processes share a number of features such as their relevance for action and learning .
BACKGROUND	On a neural level , reward and its predictors are associated with increased firing of dopaminergic neurons , whereas punishment processing has been linked to the serotonergic system and to decreases in dopamine transmission .
BACKGROUND	Recent data indicate , however , that the dopaminergic system also responds to aversive stimuli and associated actions .
OBJECTIVE	In this pharmacological functional magnetic resonance imaging study , we investigated the contribution of the dopaminergic system to reward and punishment processing in humans .
METHODS	Two groups of participants received either placebo or the dopamine precursor levodopa and were scanned during alternating reward and punishment anticipation blocks .
RESULTS	Levodopa administration increased striatal activations for cues presented in punishment blocks .
RESULTS	In an interaction with individual personality scores , levodopa also enhanced striatal activation for punishment-predictive compared with neutral cues in participants scoring higher on the novelty-seeking dimension .
CONCLUSIONS	These data support recent indications that dopamine contributes to punishment processing and suggest that the novelty-seeking trait is a measure of susceptibility to drug effects on motivation .
CONCLUSIONS	These findings are also consistent with the possibility of an inverted U-shaped response function of dopamine in the striatum , suggesting an optimal level of dopamine release for motivational processing .

###25682378
BACKGROUND	Internet-based interventions ( IBI ) are effective in treating depression .
BACKGROUND	However , uptake rates in routine care are still limited .
BACKGROUND	Hence , this study aimed to ( 1 ) assess the acceptance of IBIs in primary care patients with depressive symptoms and to ( 2 ) examine the effects of a brief acceptance facilitating intervention in the form of an informational video on patients ' acceptance of IBIs .
METHODS	Primary care patients ( N = 128 ) with Minor or Major Depression were randomly assigned to an intervention ( IG ) or control group ( CG ) .
METHODS	Patients in the IG were shown a brief informational video about IBIs before receiving a questionnaire that assessed their acceptance of IBIs and other secondary outcomes .
METHODS	Patients of the CG filled out the questionnaire immediately .
RESULTS	Baseline acceptance of IBIs in the CG was high for 6.3 % , moderate for 53.1 % and low for 40.6 % of patients .
RESULTS	Acceptance of IBIs was significantly higher in the IG when compared to the CG ( d = .71 , 95 % - CI : .09 -2.91 ) .
RESULTS	Except for social influence and the general attitude towards psychological treatment , all secondary outcomes were also significantly improved ( e.g. effort - ( d = .40 ) and performance-expectancy : d = .65 ; knowledge about Internet interventions d = .35 ) .
CONCLUSIONS	Depression of the participants was only assessed using a self-report measure ( PHQ-9 ) .
CONCLUSIONS	Primary care patients ' acceptance of IBIs for depressive symptoms was low but could be increased significantly using a brief acceptance facilitating intervention on the basis of an informational video .
CONCLUSIONS	Future studies should further examine the potential of acceptance facilitating interventions for patients and health care providers to exploit the public health impact of IBIs .

###25323203
BACKGROUND	Dissemination of psychotherapeutic modules to local counselors seems a key requirement for coping with mental health disasters in conflict regions .
BACKGROUND	We tested a train-the-trainer ( TTT ) dissemination model for the treatment of posttraumatic stress disorder ( PTSD ) .
METHODS	We randomly assigned widowed or orphaned survivors of the 1994 Rwandan genocide with a PTSD diagnosis to narrative exposure therapy ( NET ) treatment ( NET-1 , n = 38 ) or to a 6-month waiting list ( WL ) condition to be followed by treatment ( WL/NET -2 , n = 38 ) .
METHODS	Expert therapists trained a first dissemination generation of local Rwandan psychologists in NET complemented by 2 sessions of interpersonal psychotherapy modules .
METHODS	Under the supervision of the experts , these Rwandan psychologists ( a ) provided NET to the NET-1 participants and ( b ) subsequently trained and supervised a second generation of local psychologists .
METHODS	This second dissemination generation provided treatment to the WL/NET -2 group .
METHODS	The primary outcome measure was the Clinician-Administered PTSD Scale total score before therapy and at 3 - and 12-month follow-ups .
RESULTS	At the 3-month follow-up , the NET-1 participants suffered significantly and substantially less from PTSD symptoms than the participants in the WL group .
RESULTS	The treatment gains of NET-1 were maintained and increased at follow-up , with a within-group effect size of Cohen 's d = 1.47 at the 12-month follow-up .
RESULTS	After treatment by the second dissemination generation of therapists , the WL/NET -2 participants improved to an extent similar to that of the NET-1 group at follow-ups , with an effect size of Cohen 's d = 1.37 at the 12-month follow-up .
CONCLUSIONS	A TTT model of PTSD treatment dissemination can be effective in resource-poor postconflict societies .

###24366937
OBJECTIVE	This trial evaluated the efficacy of maintenance erlotinib , an epidermal growth factor receptor ( EGFR ) tyrosine kinase inhibitor , after first-line chemotherapy .
METHODS	Eligible patients had high-risk International Federation of Gynecology and Obstetrics stage I or stage II to IV epithelial ovarian , primary peritoneal , or fallopian tube cancer and were not selected for EGFR expression .
METHODS	All patients underwent first-line platinum-based chemotherapy ( CT ) and showed no signs of progression at the end of CT. .
METHODS	Patients were randomly assigned to maintenance erlotinib 150 mg orally daily for 2 years or to observation .
METHODS	EGFR immunohistochemistry ( IHC ) , fluorescent in situ hybridization ( FISH ) , and mutation analyses were performed in 318 patients .
RESULTS	Between October 2005 and February 2008 , 835 patients were randomly assigned ( median follow-up , 51 months ) .
RESULTS	Twenty-six percent of the patients stopped erlotinib as a result of adverse effects ( of these , 67 % were due to rash ) .
RESULTS	For erlotinib and observation , respectively , the median progression-free survival was 12.7 and 12.4 months ( hazard ratio [ HR ] , 1.05 ; 95 % CI , 0.90 to 1.23 ) , and the median overall survival was 50.8 and 59.1 months ( HR , 0.99 ; 95 % CI , 0.81 to 1.20 months ) , respectively .
RESULTS	No subgroup could be identified with improved effect of erlotinib , based on IHC or FISH for EGFR , or mutations in genes related to the EGFR pathway , or on rash during erlotinib therapy .
RESULTS	However , patients with a positive FISH EGFR score had a worse overall survival ( 46.1 months ) than those with a negative score ( 67.0 months ; HR , 1.56 ; 95 % CI , 1.01 to 2.40 ; P = .044 ) .
RESULTS	Global health/quality-of-life scores showed a significant difference during the first year ( P = .0102 ) in favor of the observation arm .
CONCLUSIONS	Maintenance erlotinib after first-line treatment in ovarian cancer did not improve progression-free or overall survival .

###25832689
OBJECTIVE	To evaluate factors associated with adverse cosmesis outcome in breast cancer patients randomized to accelerated partial breast irradiation ( APBI ) using 3-dimensional conformal radiation therapy or whole-breast irradiation in the RAPID ( Randomized Trial of Accelerated Partial Breast Irradiation ) trial .
METHODS	Subjects were trial participants with nurse-assessed global cosmetic scores at baseline and at 3years .
METHODS	Adverse cosmesis was defined as a score of fair or poor .
METHODS	Cosmetic deterioration was defined as any adverse change in score from baseline to 3years .
METHODS	The analysis is based on data from the previously reported interim analysis .
METHODS	Logistic regression models were used to assess the association ofrisk factors for these outcomes among all patients and those treated with APBI only .
RESULTS	Clinicopathologic characteristics were similar between subjects randomized to APBI ( n = 569 ) or whole-breast irradiation ( n = 539 ) .
RESULTS	For all subjects , factors associated with adverse cosmesis at 3years were older age , central/inner tumor location , breast infection , smoking , seroma volume , breast volume , and use of APBI ; factors associated with cosmetic deterioration were smoking , seroma volume , and use of APBI ( P < .05 ) .
RESULTS	For APBI subjects , tumor location , smoking , age , and seroma volume were associated with adverse cosmesis ( P < .05 ) , and smoking was associated with cosmetic deterioration ( P = .02 ) .
RESULTS	An independent association between the V95/whole-breast volume ratio and adverse cosmesis ( P = .28 ) or cosmetic deterioration ( P = .07 ) was not detected .
RESULTS	On further exploration a V95/whole-breast volume ratio < 0.15 was associated with a lower risk of cosmetic deterioration ( p = .04 ) , but this accounted for only 11 % of patients .
CONCLUSIONS	In the RAPID trial , a number of patient tumor and treatment-related factors , including the use of APBI , were associated with adverse cosmesis and cosmetic deterioration .
CONCLUSIONS	For patients treated with APBI alone , the high-dose treatment volume was not independently associated with an adverse cosmetic outcome , and a useful clinical threshold could not be identified .

###25151488
OBJECTIVE	Oral mucositis ( OM ) is a painful complication of radiation therapy ( RT ) for head and neck cancer ( H&NC ) .
OBJECTIVE	OM can compromise nutrition , require opioid analgesics and hospitalization for pain control , and lead to treatment interruptions .
OBJECTIVE	Based on the role of inflammatory pathways in OM pathogenesis , we investigated effect of cyclooxygenase-2 ( COX-2 ) inhibition on severity and morbidity of OM .
METHODS	In this double-blind placebo-controlled trial , 40 H&NC patients were randomized to daily use of 200 mg celecoxib or placebo , for the duration of RT. .
METHODS	Clinical OM , normalcy of diet , pain scores , and analgesic use were assessed 2-3 times/week by blinded investigators during the 6-7 week RT period , using validated scales .
RESULTS	Twenty subjects were randomized to each arm , which were similar with respect to tumor location , radiation dose , and concomitant chemotherapy .
RESULTS	In both arms , mucositis and pain scores increased over course of RT. .
RESULTS	Intention-to-treat analyses demonstrated no significant difference in mean Oral Mucositis Assessment Scale ( OMAS ) scores at 5000 cGy ( primary endpoint ) .
RESULTS	There was also no difference between the two arms in mean OMAS scores over the period of RT , mean worst pain scores , mean normalcy of diet scores , or mean daily opioid medication use in IV morphine equivalents .
RESULTS	There were no adverse events attributed to celecoxib use .
CONCLUSIONS	Daily use of a selective COX-2 inhibitor , during period of RT for H&NC , did not reduce the severity of clinical OM , pain , dietary compromise or use of opioid analgesics .
CONCLUSIONS	These findings also have implications for celecoxib use in H&NC treatment regimens ( NCT00698204 ) .

###25711325
OBJECTIVE	A proportion of HIV-positive people have condomless sex .
OBJECTIVE	Antiretroviral treatment ( ART ) reduces infectiousness , but a substantial proportion of HIV-diagnosed people are not yet on ART .
OBJECTIVE	We describe baseline self-reported risk behaviours in ART-nave Strategic Timing of AntiRetroviral Treatment ( START ) trial participants .
METHODS	All START participants completed a risk behaviour questionnaire .
METHODS	Data were collected on sociodemographics , lifestyle factors , health and wellbeing status and clinical status .
METHODS	Recent sexual behaviour and HIV transmission beliefs in the context of ART were also assessed .
METHODS	The primary interest was in condomless sex with serodifferent partners ( CLS-D ) in the past two months .
RESULTS	A total of 4601 of 4685 HIV-positive participants ( 98 % ) completed the questionnaire [ 2559 men who have sex with men ( MSM ) , 803 heterosexual men and 1239 women ] .
RESULTS	Region of recruitment was Europe/Israel , 33 % ; South America/Mexico , 25 % ; Africa , 22 % ; other , 21 % .
RESULTS	Median age was 36 years [ interquartile range ( IQR ) 29 , 44 years ] .
RESULTS	Forty-five per cent reported white ethnicity and 31 % black ethnicity .
RESULTS	Two per cent had HIV viral load < 50 HIV-1 RNA copies/mL .
RESULTS	Seventeen per cent ( 767 of 4601 ) reported CLS-D ; 20 % of MSM compared with 10 % of heterosexual men and 14 % of women .
RESULTS	MSM were also more likely to report multiple CLS-D partners .
RESULTS	Possible risk limitation measures ( reported by more than half of those who had CLS-D ) were seropositioning ( receptive anal CLS-D only ) or withdrawal ( insertive anal CLS-D always without ejaculation ) .
RESULTS	CLS-D was more commonly reported by participants from South America/Mexico and North America compared with Europe ; among heterosexual men and women CLS-D was also more commonly reported among participants from Africa compared with Europe .
RESULTS	Knowledge of ART impact on transmission risk was low .
CONCLUSIONS	A substantial minority recruited to the START study reported CLS-D at baseline .
CONCLUSIONS	CLS-D reporting was higher in MSM than heterosexuals and varied significantly according to region of recruitment .
CONCLUSIONS	A substantial proportion of MSM reporting CLS-D appear to take transmission risk limitation measures .

###24933238
OBJECTIVE	It has been shown that the myocutaneous latissimus dorsi flap volume and consistency remain mainly the same regardless the nerve is cut or not in breast reconstruction .
OBJECTIVE	It is controversial how big an impact the flap innervation has on the muscle activity of the flap .
OBJECTIVE	The aim of the study was to prospectively evaluate the influence of latissimus dorsi flap innervation on the functional and aesthetic outcome of delayed breast reconstruction .
METHODS	Between 2007 and 2008 , 28 breast reconstructions were performed and randomly divided into denervation group ( surgical denervation by excision of 1 cm of proximal thoracodorsal nerve , n = 14 ) and innervation group ( thoracodorsal nerve saved intact , n = 14 ) .
METHODS	Patients were clinically evaluated and a questionnaire considering functional and aesthetic outcome was filled 1-year after operation .
METHODS	Muscular twitching , pain , tightness , shape and symmetry of the breasts were evaluated .
METHODS	In addition , the mobility of the shoulder joint on the operated side was evaluated and the patients self-estimated the activities of daily living .
RESULTS	There was no significant difference in latissimus dorsi flap twitching , pain and tightness of the breast and symmetry and shape of the breasts between denervated and innervated groups .
RESULTS	The shoulder joint mobility was not found to be changed significantly in either of the groups and there were no limitations in activities of daily living .
CONCLUSIONS	Thoracodorsal nerve division or preservation does not significantly affect muscle contraction activity of the latissimus dorsi flap and distortion of the breast when latissimus dorsi muscle humeral insertion is also detached .
CONCLUSIONS	Therefore , both cutting and saving the nerve are justified in latissimus dorsi flap breast reconstruction depending on whether the humeral insertion of the muscle is preserved intact or divided and the flap islanded .
CONCLUSIONS	The study shows that there is no tangible benefit in dividing the nerve when the flap is islanded .
CONCLUSIONS	Clinical trial has been registered in public trials registry .
CONCLUSIONS	Trial registry name is ` The significance of latissimus dorsi flap innervation in delayed breast reconstruction ' .
CONCLUSIONS	Registration number is NCT01239524 and URL is https://register.clinicaltrials.gov .

###24435882
BACKGROUND	We examined the effect of caffeine ingestion on muscle torque production and muscle activity at different contraction speeds in trained men .
METHODS	10 men ( mean age SD = 22 1.1 years ) volunteered to participate .
METHODS	A double-blind , randomized cross-over design was used .
METHODS	Sixty minutes postingestion of caffeine ( 6 mg kg ( -1 ) ) or placebo , participants completed 6 repetitions of isokientic knee extension at 3 angular velocities ( 30s ( -1 ) , 150s ( -1 ) , 300s ( -1 ) ) from which peak torque was determined .
METHODS	Electromyographic activity of the vastus medialis was also collected .
RESULTS	Repeated measures analysis of variance indicated that muscle torque production was significantly higher ( P = 0.02 ) with caffeine compared with placebo .
RESULTS	A significant ( P = 0.02 ) substance by velocity interaction for muscle activity indicated significantly higher vastus medialis muscle activity in the presence of caffeine versus placebo , and this difference was amplified as angular velocity increased .
CONCLUSIONS	Acute caffeine ingestion improves muscle performance and increases muscle activity during short-duration maximal dynamic contractions .

###25134002
OBJECTIVE	Performance improvements after caffeine ( CAF ) ingestion are well documented when using a 1-d protocol .
OBJECTIVE	In numerous competitions such as the Tour de France , Tour de Ski , world championships , and National College Athletic Association championships , athletes compete for several days in a row .
OBJECTIVE	To date , no studies have investigated the effects of CAF when competing for consecutive days in a row .
OBJECTIVE	This study aimed to investigate the effects of placebo ( PLA ) and two different CAF doses ( 3 and 4.5 mgkg body mass ) on performance in a 10-min all-out , cross-country , double poling ergometer test ( C-PT ) 2 d in a row .
METHODS	Eight highly trained male cross-country skiers ( VO2max-run , 78.5 1.6 mLkgmin ) participated in the study , which was a randomized , double-blind , PLA-controlled , crossover design .
METHODS	Performance was assessed as distance covered during a 10-min all-out C-PT .
METHODS	Oral ingestion of CAF or PLA was consumed 75 min before the all-out C-PT .
RESULTS	Poling distance was improved after CAF ingestions compared with that after PLA on both days .
RESULTS	The improvements on day 1 were 4.0 % ( 90 % confidence limits , 3.3 ) and 4.0 % 2.9 % for both CAF doses , respectively ( P < 0.05 ) , whereas improvements on day 2 were 5.0 % 3.6 % and 5.1 % 2.8 % for CAF3 and CAF4 .5 , respectively , compared with those for PLA .
RESULTS	Improved performance was associated with increased HR , adrenaline concentration , blood lactate concentration , and VO2 consumption after CAF ingestion .
RESULTS	Furthermore , performance was elevated despite higher creatine kinase concentration and muscular pain at arrival on day 2 for both CAF doses .
CONCLUSIONS	Both CAF doses improved performance in the 10-min all-out C-PT compared with PLA over two consecutive days .
CONCLUSIONS	Therefore , CAF seems useful for athletes competing over consecutive days despite higher muscle damage occurring after enhanced performance on the first day .

###24349257
BACKGROUND	When compared with more traditional instructional methods , Game-based e-learning ( GbEl ) promises a higher motivation of learners by presenting contents in an interactive , rule-based and competitive way .
BACKGROUND	Most recent systematic reviews and meta-analysis of studies on Game-based learning and GbEl in the medical professions have shown limited effects of these instructional methods .
OBJECTIVE	To compare the effectiveness on the learning outcome of a Game-based e-learning ( GbEl ) instruction with a conventional script-based instruction in the teaching of phase contrast microscopy urinalysis under routine training conditions of undergraduate medical students .
METHODS	A randomized controlled trial was conducted with 145 medical students in their third year of training in the Department of Urology at the University Medical Center Freiburg , Germany .
METHODS	82 subjects where allocated for training with an educational adventure-game ( GbEl group ) and 69 subjects for conventional training with a written script-based approach ( script group ) .
METHODS	Learning outcome was measured with a 34 item single choice test .
METHODS	Students ' attitudes were collected by a questionnaire regarding fun with the training , motivation to continue the training and self-assessment of acquired knowledge .
RESULTS	The students in the GbEl group achieved significantly better results in the cognitive knowledge test than the students in the script group : the mean score was 28.6 for the GbEl group and 26.0 for the script group of a total of 34.0 points with a Cohen 's d effect size of 0.71 ( ITT analysis ) .
RESULTS	Attitudes towards the recent learning experience were significantly more positive with GbEl .
RESULTS	Students reported to have more fun while learning with the game when compared to the script-based approach .
CONCLUSIONS	Game-based e-learning is more effective than a script-based approach for the training of urinalysis in regard to cognitive learning outcome and has a high positive motivational impact on learning .
CONCLUSIONS	Game-based e-learning can be used as an effective teaching method for self-instruction .

###24886179
BACKGROUND	Depression is a high prevalence disorder , displaying high rates of lifetime incidence , early age onset , high chronicity , and role impairment .
BACKGROUND	In Ireland 12-month prevalence of depression has been reported to be 10.3 % .
BACKGROUND	A large percentage of affected individuals have no medical diagnosis nor seek treatment .
BACKGROUND	Cognitive Behavior Therapy ( CBT ) has established itself as an option for the treatment of depression .
BACKGROUND	Many Irish adults with depression find it difficult to access evidence-based CBT , this is due to several factors , like stigma and costs .
BACKGROUND	However , systematic factors including the shortage of trained professionals and the relative underdevelopment of services also make access difficult.Stepped-care can increase access to evidence-based CBT .
BACKGROUND	One option is tailored internet-delivered treatment programs .
BACKGROUND	Preliminary research from Ireland needs now to include large-scale studies on effectiveness .
BACKGROUND	Thus the current study seeks to examine the potential of an internet-delivered low-intensity treatment for symptoms of depression in an Irish adult community sample .
METHODS	The study is a randomized controlled trial of an online CBT ( iCBT ) program for the treatment of adults with depressive symptoms .
METHODS	The trial will include an active treatment group and a waiting-list control group .
METHODS	The active condition will consist of 8 weekly modules of iCBT , with post-session feedback support .
METHODS	Participants in the waiting list will receive access to the treatment at week 8 .
METHODS	Participants will complete the Beck Depression Inventory ( BDI-II ) and eligibility criteria will also apply .
METHODS	Primary outcomes are depressive symptoms .
METHODS	Secondary outcomes include quality of life indicators , significant events and satisfaction with online treatment .
METHODS	Data will be collected at baseline and at post-treatment , week 8 , and at follow-up week 20 ( 3-months ) and week 32 ( 6-months ) .
METHODS	Analysis will be conducted on the intention-to-treat basis .
CONCLUSIONS	The study seeks to evaluate the effectiveness of an online delivered treatment for depression in a community sample of Irish adults with symptoms of depression .
CONCLUSIONS	The study will be a first contribution and depending on the sample recruited the results may be generalizable to people with similar difficulties in Ireland and may therefore give insight into the potential of low-intensity interventions for Irish people with depressive symptoms .
BACKGROUND	Current Controlled Trials ISRCTN03704676 .
BACKGROUND	DOI : 10.1186 / ISRCTN03704676 .

###25181492
BACKGROUND	Regular breakfast consumption may protect against type 2 diabetes risk in adults but little is known about its influence on type 2 diabetes risk markers in children .
BACKGROUND	We investigated the associations between breakfast consumption ( frequency and content ) and risk markers for type 2 diabetes ( particularly insulin resistance and glycaemia ) and cardiovascular disease in children .
RESULTS	We conducted a cross-sectional study of 4,116 UK primary school children aged 9-10 years .
RESULTS	Participants provided information on breakfast frequency , had measurements of body composition , and gave fasting blood samples for measurements of blood lipids , insulin , glucose , and glycated haemoglobin ( HbA1c ) .
RESULTS	A subgroup of 2,004 children also completed a 24-hour dietary recall .
RESULTS	Among 4,116 children studied , 3,056 ( 74 % ) ate breakfast daily , 450 ( 11 % ) most days , 372 ( 9 % ) some days , and 238 ( 6 % ) not usually .
RESULTS	Graded associations between breakfast frequency and risk markers were observed ; children who reported not usually having breakfast had higher fasting insulin ( percent difference 26.4 % , 95 % CI 16.6 % -37.0 % ) , insulin resistance ( percent difference 26.7 % , 95 % CI 17.0 % -37.2 % ) , HbA1c ( percent difference 1.2 % , 95 % CI 0.4 % -2.0 % ) , glucose ( percent difference 1.0 % , 95 % CI 0.0 % -2.0 % ) , and urate ( percent difference 6 % , 95 % CI 3 % -10 % ) than those who reported having breakfast daily ; these differences were little affected by adjustment for adiposity , socioeconomic status , and physical activity levels .
RESULTS	When the higher levels of triglyceride , systolic blood pressure , and C-reactive protein for those who usually did not eat breakfast relative to those who ate breakfast daily were adjusted for adiposity , the differences were no longer significant .
RESULTS	Children eating a high fibre cereal breakfast had lower insulin resistance than those eating other breakfast types ( p for heterogeneity < 0.01 ) .
RESULTS	Differences in nutrient intakes between breakfast frequency groups did not account for the differences in type 2 diabetes markers .
CONCLUSIONS	Children who ate breakfast daily , particularly a high fibre cereal breakfast , had a more favourable type 2 diabetes risk profile .
CONCLUSIONS	Trials are needed to quantify the protective effect of breakfast on emerging type 2 diabetes risk .
CONCLUSIONS	Please see later in the article for the Editors ' Summary .

###24978090
OBJECTIVE	The goal of this study was to determine if a robotic dry laboratory curriculum for gynecology and urology residents improved their basic robotic skills .
METHODS	After the institution-specific institutional review board approval or exemption , 165 residents from 8 gynecology and/or urology programs were enrolled .
METHODS	Residents underwent standardized robotic orientation followed by dry laboratory testing on 4 unique robotic tasks .
METHODS	Residents were block randomized by program to unstructured or structured training programs .
METHODS	Regardless of group , residents were expected to practice for 15 minutes twice monthly over 7 months .
METHODS	Errors , time to completion , and objective structured assessment of technical skills global rating scores were recorded for each task before and after the training period .
METHODS	Statistics were calculated using the Student t tests , Pearson correlation , and analysis of variance with STATA systems ( version 11.2 ) .
RESULTS	A total of 99 residents completed both the pretraining and posttraining testing .
RESULTS	A mean of 4 ( range , 0-15 ) 15-minute training sessions per resident was self-reported .
RESULTS	The structured group had faster posttraining times on the transection task , although the unstructured group had higher posttraining scores on the knot-tying task .
CONCLUSIONS	Overall , the residents ' robotic skills improved after participating in a dry laboratory curriculum ; however , robotic availability , duty hour restrictions , and clinical responsibilities limit the curriculum implementation .

###25902591
BACKGROUND	More than 50 % of children in Nepal are malnourished .
BACKGROUND	Economic growth and poverty reduction are not always sufficient to improve the health and nutritional status of children .
BACKGROUND	Heifer Nepal uses livestock training as a tool for community development and poverty alleviation but does not directly address child health and nutrition .
OBJECTIVE	To systematically assess the effects of Heifer activities on child health and nutrition .
METHODS	The study was a 2-year , longitudinal , randomized , controlled trial in six communities in Nepal ( both Terai and hills ) , pair-matched for specific characteristics , randomly assigned to receive Heifer community development activities at baseline ( intervention ) or 1 year ( control ) .
METHODS	At 6-month intervals over a period of 2 years , child anthropometric and comprehensive household surveys were performed .
RESULTS	Four hundred fifteen households were enrolled containing 607 children 6 months to 5 years of age .
RESULTS	The intervention and control communities were equivalent for baseline socioeconomic status , household size , ownership of land and animals , and child nutrition and health .
RESULTS	At 12 months ( prior to animal donations ) , the Terai intervention group had improved child weight ( p = .04 ) , improved child height ( p = .05 ) , and reduced sick days ( p = .03 ) , as well as increased household income ( p = .004 ) , increased ownership of animals ( p = .04 ) and land ( p = .04 ) , and improved sanitation practices ( p < .01 ) .
RESULTS	In all districts , longer participation in Heifer activities corresponded to more improvement in child height-for-age z-scores .
CONCLUSIONS	Heifer interventions resulted in improved socioeconomic status and household income per family member .
CONCLUSIONS	Children under 60 months of age in the intervention group had greater incremental improvement in height-for-age and weight-for-age z-scores than children in the control group , and longer participation in Heifer activities was associated with better growth .
CONCLUSIONS	Poverty alleviation programs , such as Heifer , may indirectly benefit child growth .

###25746580
OBJECTIVE	To evaluate whether anticholinergic medication contributes to early recovery of continence and improvement of other voiding symptoms after radical prostatectomy ( RP ) .
METHODS	A total of 78 patients with clinically localized prostate cancer who had incontinence at 1 week after RP were enrolled prospectively .
METHODS	The patients were allocated to one of the 2 groups : group 1 ( - adrenergic agonist [ midodrine ] plus an anticholinergic [ solifenacin ] ) or group 2 ( - adrenergic agonist only ) .
METHODS	A urodynamic study and the International Continence Society male Short Form questionnaire were completed preoperatively and 4 months after RP .
METHODS	One-hour pad test and 3-day frequency volume chart at 1 and 4 months after medication were also analyzed .
RESULTS	The rate of continence , defined as being pad free , did not differ between the groups at 4 months ( both 71.8 % ; P > .05 ) .
RESULTS	However , the decreased value of mean weight of daily pads worn by groups 1 and 2 were 51.5 vs 11.7 g , respectively ( P = .005 ) .
RESULTS	The incontinence ( P = .008 ) and quality of life ( P = .044 ) subscale scores significantly worsened in group 2 , whereas they remained unchanged in group 1 .
RESULTS	Maximal detrusor pressure and maximal urethral closure pressure significantly decreased in both groups , whereas maximal cystometric capacity increased significantly in group 1 only ( 290.8-332 .0 cm H2O ; P < .001 ) .
CONCLUSIONS	Anticholinergics may facilitate early recovery from incontinence and prevent worsening of quality of life , which might be attributed to increased cystometric capacity after their use .

###24287639
OBJECTIVE	Endoscopic biliary sphincterotomy ( EBS ) results in permanent loss of sphincter function and its long-term complications are unknown .
OBJECTIVE	Endoscopic papillary balloon dilation ( EPBD ) is an alternative procedure that preserves sphincter function , although it is associated with a higher risk of pancreatitis than is EBS .
OBJECTIVE	The aim of this study was to evaluate the safety and outcomes of EPBD with limited indications for removal of common bile duct ( CBD ) stones combined with gallstones in patients younger than 40 years .
METHODS	Young ( age < 40 years ) patients who had CBD stones combined with gallstones on imaging studies were enrolled in this study .
METHODS	A total of 132 patients were randomly divided into the EPBD group ( n = 62 ) or the EBS group ( n = 70 ) for extraction of CBD stones .
METHODS	The ballooning size of EPBD ranged from 6 to 10 mm .
RESULTS	Complete bile duct clearance was achieved in 98.4 % ( 61/62 ) of the EPBD group and 100 % ( 70/70 ) of the EBS group .
RESULTS	Mechanical lithotripsy was required in 8.1 % ( 5/62 ) of the EPBD group and 8.6 % ( 6/70 ) of the EBS group .
RESULTS	The early complication rates were 8.1 % ( 5/62 ) ( five pancreatitis ) in the EPBD group and 11.4 % ( 8/70 ) ( five [ 7.1 % ] pancreatitis , two bleeding and one perforation ) in the EBS group .
RESULTS	The recurrence rates of CBD stones were 1.6 % ( 1/62 ) in the EPBD group and 5.7 % ( 4/70 ) in the EBS group .
CONCLUSIONS	EPBD with limited indications was safe and effective as EBS for removal of CBD stones combined with gallstones in young patients who had a longer life expectancy .

###25211714
OBJECTIVE	We tested the efficacy of an adapted evidence-based HIV-sexually transmitted infection ( STI ) behavioral intervention ( Providing Opportunities for Women 's Empowerment , Risk-Reduction , and Relationships , or POWER ) among incarcerated women .
METHODS	We conducted a randomized trial with 521 women aged 18 to 60 years in 2 correctional facilities in North Carolina in 2010 and 2011 .
METHODS	Intervention participants attended 8 POWER sessions ; control participants received a single standard-of-care STI prevention session .
METHODS	We followed up at 3 and 6 months after release .
METHODS	We examined intervention efficacy with mixed-effects models .
RESULTS	POWER participants reported fewer male sexual partners than did control participants at 3 months , although this finding did not reach statistical significance ; at 6 months they reported significantly less vaginal intercourse without a condom outside of a monogamous relationship and more condom use with a main male partner .
RESULTS	POWER participants also reported significantly fewer condom barriers , and greater HIV knowledge , health-protective communication , and tangible social support .
RESULTS	The intervention had no significant effects on incident STIs .
CONCLUSIONS	POWER is a behavioral intervention with potential to reduce risk of acquiring or transmitting HIV and STIs among incarcerated women returning to their communities .

###24523483
OBJECTIVE	We compared the efficacy of IV valproate with metoclopramide and with ketorolac in patients presenting to an emergency department ( ED ) with acute migraine .
METHODS	This was a double-blind comparative efficacy trial .
METHODS	Patients were randomized to 1,000 mg sodium valproate , 10 mg metoclopramide , or 30 mg ketorolac , each administered as an IV drip over 15 minutes .
METHODS	The primary outcome was improvement in headache by 1 hour , measured on a verbal 0 to 10 scale , at baseline and 60 minutes later .
METHODS	Important secondary outcomes included ( 1 ) need for rescue medication in the ED , and ( 2 ) sustained headache freedom .
RESULTS	Three hundred thirty patients were enrolled over 30 months beginning in October 2010 .
RESULTS	Baseline characteristics were comparable among the 3 arms .
RESULTS	On the primary outcome , patients receiving IV valproate improved by a mean of 2.8 ( 95 % confidence interval [ CI ] : 2.3 , 3.3 ) on the 0 to 10 scale ; those receiving IV metoclopramide improved by 4.7 ( 95 % CI : 4.2 , 5.2 ) ; and those receiving IV ketorolac improved by 3.9 ( 95 % CI : 3.3 , 4.5 ) .
RESULTS	On the secondary endpoints , 69 % ( 95 % CI : 60 % , 78 % ) of patients receiving valproate required rescue medication , compared with 33 % ( 95 % CI : 24 % , 42 % ) of metoclopramide patients and 52 % ( 95 % CI : 42 % , 63 % ) of those assigned to ketorolac .
RESULTS	Sustained headache freedom was achieved in 4 % ( 95 % CI : 0 % , 7 % ) of those randomized to valproate , 11 % ( 95 % CI : 5 % , 17 % ) of metoclopramide patients , and 16 % ( 95 % CI : 9 % , 23 % ) receiving ketorolac .
RESULTS	In the metoclopramide arm , 6 % ( 95 % CI : 3 % , 12 % ) of patients reported feeling `` very restless '' after investigational medication administration .
CONCLUSIONS	Valproate was less efficacious than either metoclopramide or ketorolac .
CONCLUSIONS	Metoclopramide demonstrated superiority to ketorolac on several endpoints .
METHODS	This study provides Class I evidence that in ED patients with acute migraine , IV valproate is inferior to metoclopramide or ketorolac in improving headache outcomes .

###24703523
OBJECTIVE	To evaluate the effect of a combined hospital plus home exercise programme following curative surgery for non-small cell lung cancer ( NSCLC ) .
METHODS	Randomised controlled trial .
METHODS	Teaching hospital .
METHODS	One hundred and thirty-one subjects with NSCLC admitted for curative surgery .
METHODS	Participants were randomised to usual care or a hospital plus home exercise programme .
RESULTS	The primary outcome was the between-group difference in physical activity 4 weeks after surgery .
RESULTS	Secondary outcomes were the difference in quadriceps strength , exercise tolerance and quality of life [ Short Form-36 ( SF-36 ) and European Organisation for Research and Treatment of Cancer ( EORTC ) QLQ-LC13 ] from pre-operatively ( baseline ) to 4 weeks after surgery .
RESULTS	The participants ( n = 131 ) had a mean age of 68 [ standard deviation ( SD ) 11 ] years and mean forced expiratory volume in 1 second of 2.4 ( SD 1.1 ) l.
RESULTS	There were no significant differences in physical activity between the groups 4 weeks after surgery [ mean difference adjusted for baseline 12minutes/day , 95 % confidence interval ( CI ) -20.2 to 44.1 ] .
RESULTS	In addition , there were no significant differences in total SF-36 or EORTC QLQ-LC13 scores from baseline to 4 weeks after surgery .
RESULTS	Both groups had recovered their pre-operative walking distance 4 weeks after surgery , and there were no differences between the groups ( mean difference in Incremental Shuttle Walk Test from baseline to 4 weeks after surgery ( -26 m , 95 % CI -94.2 to 42.3 ) .
CONCLUSIONS	A hospital plus home exercise programme showed little benefit in unselected patients with NSCLC following surgery .
CONCLUSIONS	Regardless of group allocation , the patients had recovered their pre-operative exercise tolerance levels by 4 weeks after surgery .

###24476416
BACKGROUND	The aim of this study was to investigate the influence of symptom duration on treatment response and on the correlation between improvements in patient reported outcomes ( PRO ) and objective inflammation in patients with axial spondylarthritis ( SpA ) treated with etanercept ( ETA ) or adalimumab ( ADA ) .
METHODS	Data from 112 patients with axial SpA originally enrolled in two randomized controlled clinical trials were pooled and analyzed after one year of treatment with ETA ( n = 66 ) or ADA ( n = 46 ) .
METHODS	Patients with < 4 years and 4 years of disease were compared for improvement in Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) , Bath Ankylosing Spondylitis Functional Index ( BASFI ) , Ankylosing Spondylitis Disease Activity Score ( ASDAS ) , C-reactive protein ( CRP ) and magnetic resonance imaging ( MRI ) score for sacroiliac joints ( SIJ ) .
RESULTS	Patients with < 4 years of disease showed a significantly better improvement than longer diseased patients in BASDAI ( 3.2 ( 95 % confidence interval ( CI ) : 2.7 to 3.7 ) vs. 1.7 ( 1.1 to 2.2 ) ) , BASFI , BASMI and ASDAS ( 1.6 ( 1.4 to 1.8 ) vs. 0.9 ( 0.7 to 1.1 ) ) .
RESULTS	The change in BASDAI showed a significant correlation with the change in SIJ score ( Spearman 's rank correlation coefficient ( rho ) = 0.37 , P = 0.01 ) and the change in CRP ( rho = 0.45 , P = 0.001 ) in patients with < 4 years of disease .
RESULTS	For long diseased patients this correlation was poor and did not achieve statistical significance ( rho = 0.13 , P = 0.46 ; rho = 0.22 , P = 0.13 respectively ) .
CONCLUSIONS	The low correlation between change of PROs and change of objective signs of inflammation seen in axial SpA patients with longer symptom duration treated with tumor necrosis factor-blocker seems to indicate that inflammation is not the only cause of the patients ' symptoms , while inflammation seems to be the major cause in short diseased patients .
BACKGROUND	Clinical Trials.gov NCT00844142 ( Trial 1 ) ; NCT00235105 ( Trial 2 ) .

###24280479
BACKGROUND	Patients scheduled to invasive medical procedures experience high levels of anxiety , which may lead to increased perceptions of pain and vital sign instability throughout .
OBJECTIVE	To examine the effect of a music intervention ( MI ) on stress hormones , physiologic parameters , pain , and anxiety state before and during port catheter placement procedures ( PCPPs ) .
METHODS	We conducted a prospective , randomized , controlled study in 100 oncology patients , who were randomly assigned to an MI group ( n = 50 ) or a control group ( n = 50 ) .
METHODS	The effects of music were assessed by determination of serum cortisol and adrenocorticotropic hormone ( ACTH ) levels , heart and respiratory rate ( HR , RR ) and systolic and diastolic blood pressure ( SBP , DBP ) , on arrival in the surgical intervention room , as well as immediately prior to and immediately after the PCPP , in both groups .
METHODS	Furthermore , pain and anxiety levels were identified using visual analogue scale and state-trait anxiety inventory scales .
RESULTS	On arrival , there were no differences between the patients in terms of serum cortisol and ACTH levels , HR , RR , SBP , DBP and anxiety levels .
RESULTS	There were significant reductions in hormone levels ( p < 0.05 for all ) , HR ( p < 0.001 ) , RR ( p < 0.001 ) , SBP ( p < 0.05 ) and DBP ( p < 0.05 ) , immediately prior to and immediately after the PCPP in participants in the MI group compared to those in the control group .
RESULTS	Furthermore , music led to a significant reduction in pain ( p < 0.05 ) and anxiety scores ( p < 0.05 ) in the MI group compared to control group .
CONCLUSIONS	During invasive medical procedures , MI significantly decreases stress hormone levels , physiological parameters , acute procedural pain and anxiety .

###25211285
OBJECTIVE	To assess development of fatigue during chest compressions ( CCs ) in simulated neonatal cardiopulmonary resuscitation ( CPR ) .
METHODS	Prospective randomized manikin crossover study .
METHODS	Thirty neonatal healthcare professionals who successfully completed the Neonatal Resuscitation Program performed CPR using ( i ) 3:1 compression : ventilation ( C : V ) ratio , ( ii ) continuous CC with asynchronous ventilation ( CCaV ) at a rate of 90 CC per min and ( iii ) CCaV at 120 CC per min for a duration of 10 min on a neonatal manikin .
METHODS	Changes in peak pressure ( a surrogate of fatigue ) and CC rate were continuously recorded and fatigue among groups was compared .
METHODS	Participants were blinded to pressure tracings and asked to rate their level of comfort and fatigue for each CPR trial .
RESULTS	Compared with baseline , a significant decrease in peak pressure was observed after 72 , 96 and 156 s in group CCaV-120 , CCaV-90 and 3:1 C : V , respectively .
RESULTS	CC depth decreased by 50 % within the first 3 min during CCaV-120 , 30 % during CCaV-90 and 20 % during 3:1 C : V. Moreover , 3:1 C : V and CCaV were similarly preferred by healthcare professionals .
CONCLUSIONS	Similarly , 3:1 C : V and CCaV CPR were also fatiguing .
CONCLUSIONS	We recommend that rescuers should switch after every second cycle of heart rate assessment during neonatal CPR .

###24794368
OBJECTIVE	Biliary atresia is the most common cause of end-stage liver disease in children .
OBJECTIVE	Controversy exists as to whether use of steroids after hepatoportoenterostomy improves clinical outcome .
OBJECTIVE	To determine whether the addition of high-dose corticosteroids after hepatoportoenterostomy is superior to surgery alone in improving biliary drainage and survival with the native liver .
METHODS	The multicenter , double-blind Steroids in Biliary Atresia Randomized Trial ( START ) was conducted in 140 infants ( mean age , 2.3 months ) between September 2005 and February 2011 in the United States ; follow-up ended in January 2013 .
METHODS	Participants were randomized to receive intravenous methylprednisolone ( 4 mg/kg/d for 2 weeks ) and oral prednisolone ( 2 mg/kg/d for 2 weeks ) followed by a tapering protocol for 9 weeks ( n = 70 ) or placebo ( n = 70 ) initiated within 72 hours of hepatoportoenterostomy .
METHODS	The primary end point ( powered to detect a 25 % absolute treatment difference ) was the percentage of participants with a serum total bilirubin level of less than 1.5 mg/dL with his/her native liver at 6 months posthepatoportoenterostomy .
METHODS	Secondary outcomes included survival with native liver at 24 months of age and serious adverse events .
RESULTS	The proportion of participants with improved bile drainage was not statistically significantly improved by steroids at 6 months posthepatoportoenterostomy ( 58.6 % [ 41/70 ] of steroids group vs 48.6 % [ 34/70 ] of placebo group ; adjusted relative risk , 1.14 [ 95 % CI , 0.83 to 1.57 ] ; P = .43 ) .
RESULTS	The adjusted absolute risk difference was 8.7 % ( 95 % CI , -10.4 % to 27.7 % ) .
RESULTS	Transplant-free survival was 58.7 % in the steroids group vs 59.4 % in the placebo group ( adjusted hazard ratio , 1.0 [ 95 % CI , 0.6 to 1.8 ] ; P = .99 ) at 24 months of age .
RESULTS	The percentage of participants with serious adverse events was 81.4 % [ 57/70 ] of the steroids group and 80.0 % [ 56/70 ] of the placebo group ( P > .99 ) ; however , participants receiving steroids had an earlier time of onset of their first serious adverse event by 30 days posthepatoportoenterostomy ( 37.2 % [ 95 % CI , 26.9 % to 50.0 % ] of steroids group vs 19.0 % [ 95 % CI , 11.5 % to 30.4 % ] of placebo group ; P = .008 ) .
CONCLUSIONS	Among infants with biliary atresia who have undergone hepatoportoenterostomy , high-dose steroid therapy following surgery did not result in statistically significant treatment differences in bile drainage at 6 months , although a small clinical benefit could not be excluded .
CONCLUSIONS	Steroid treatment was associated with earlier onset of serious adverse events in children with biliary atresia .
BACKGROUND	clinicaltrials.gov Identifier : NCT00294684 .

###24440221
OBJECTIVE	A previous randomized , placebo-controlled study showed that infliximab maintenance therapy prevented recurrence of Crohn 's disease 1 year after an ileocolonic resection .
OBJECTIVE	We evaluated recurrence of Crohn 's disease , on the basis of endoscopic examination and/or the need for additional surgical resection , beyond the first postoperative year .
METHODS	In a prospective , open-label , long-term follow-up study , 24 patients previously randomly assigned to receive infliximab for 1 year after an ileocolonic resection were given the option to continue , stop , or start infliximab therapy .
METHODS	The primary end point was the time to recurrence of Crohn 's disease , on the basis of endoscopic evidence ( endoscopic recurrence ) , from the initial assignment to postoperative infliximab or placebo .
METHODS	Secondary end points were rate of endoscopic recurrence , time to reoperation , and rate of surgical recurrence in relation to the total time on infliximab .
RESULTS	All patients were followed for at least 5 years after surgery .
RESULTS	Patients assigned to the infliximab group in the first year after surgery had a longer mean time to first endoscopic recurrence ( 1231 747 days ) than patients originally assigned to the placebo group ( 460 121 days , P = .003 ) .
RESULTS	Colonoscopies identified Crohn 's disease recurrence in 22.2 % of patients who received long-term infliximab and in 93.9 % of those not on infliximab ( P < .0001 ) .
RESULTS	Compared with no infliximab , the adjusted rate ratio for being in endoscopic remission while on infliximab was 13.47 ( 95 % confidence interval , 3.52-61 .53 ; P = .0001 ) .
RESULTS	Patients originally assigned to the infliximab group had a mean longer time to surgery ( 1798 359 days ) than patients originally assigned to the placebo group ( 1058 529 days , P = .04 ) .
RESULTS	The rate of surgical recurrence ( required additional surgical resection ) was significantly lower among patients who received infliximab for most of the follow-up period than patients who received it for shorter periods ( 20.0 % vs 64.3 % , P = .047 ) .
CONCLUSIONS	Postoperative infliximab maintenance beyond 1 year prevents recurrence of Crohn 's disease .

###24562873
BACKGROUND	A web-based followup assessment may be a feasible , cost-saving alternative of tracking patient outcomes after total joint arthroplasty .
BACKGROUND	However , before implementing a web-based program , it is important to determine patient satisfaction levels with the new followup method .
BACKGROUND	Satisfaction with the care received is becoming an increasingly important metric , and we do not know to what degree patients are satisfied with an approach to followup that does not involve an in-person visit with their surgeons .
OBJECTIVE	We determined ( 1 ) patient satisfaction and ( 2 ) patients ' preferences for followup method ( web-based or in-person ) after total joint arthroplasty .
METHODS	We randomized patients who were at least 12 months after primary THA or TKA to complete a web-based followup or to have their appointment at the clinic .
METHODS	There were 410 eligible patients contacted for the study during the recruitment period .
METHODS	Of these , 256 agreed to participate , and a total of 229 patients completed the study ( 89 % of those enrolled , 56 % of those potentially eligible ; 111 in the usual-care group , 118 in the web-based group ) .
METHODS	Their mean age was 69 years ( range , 38-86 years ) .
METHODS	There was no crossover between groups .
METHODS	All 229 patients completed a satisfaction questionnaire at the time of their followup appointments .
METHODS	Patients in the web-based group also completed a satisfaction and preference questionnaire 1 year later .
METHODS	Only patients from the web-based group were asked to indicate preference as they had experienced the web-based and in-person followup methods .
METHODS	We used descriptive statistics to summarize the satisfaction questionnaires and compared results using Pearson 's chi-square test .
RESULTS	Ninety-one patients ( 82.0 % ) in the usual-care group indicated that they were either extremely or very satisfied with the followup process compared with 90 patients ( 75.6 % ) who were in the web-based group ( p < 0.01 ; odds ratio [ OR ] = 3.95 ; 95 % CI , 1.79-8 .76 ) .
RESULTS	Similarly , patients in the usual care group were more satisfied with the care they received from their surgeon , compared with patients in the web-based group ( 92.8 % versus 73.9 % ; p < 0.01 , OR = 1.37 ; 95 % CI , 0.73-2 .57 ) .
RESULTS	Forty-four percent of patients preferred the web-based method , 36 % preferred the usual method , and 16 % had no preference ( p = 0.01 ) .
CONCLUSIONS	Our results show moderate to high satisfaction levels with a web-based followup assessment .
CONCLUSIONS	Patients who completed the usual method of in-person followup assessment reported greater satisfaction ; however , the difference was small and may not outweigh the additional cost and time-saving benefits of the web-based followup method .
METHODS	Level I , therapeutic study .
METHODS	See the Instructions for Authors for a complete description of levels of evidence .

###24616451
OBJECTIVE	Endocannabinoid system ( ECS ) activation promotes obesity-associated metabolic disease .
OBJECTIVE	Increased dietary fat intake increases blood endocannabinoids and alters adipose and skeletal muscle ECS gene expression in human .
METHODS	Two weeks isocaloric low - ( LFD ) and high-fat diets ( HFD ) in obese ( n = 12 ) and normal-weight ( n = 17 ) subjects in a randomized cross-over study were compared .
METHODS	Blood endocannabinoids were measured in the fasting condition and after food intake using mass spectrometry .
METHODS	Adipose and skeletal muscle gene expression was determined using real-time RT-PCR .
RESULTS	Baseline fasting plasma endocannabinoids were similar with both diets .
RESULTS	Anandamide decreased similarly with high - or low-fat test meals in both groups .
RESULTS	Baseline arachidonoylglycerol plasma concentrations were similar between groups and diets , and unresponsive to eating .
RESULTS	In subcutaneous adipose tissue , DAGL - mRNA was upregulated and fatty acid amide hydrolase ( FAAH ) and monoacylglycerol lipase ( MAGL ) mRNAs were down-regulated in obese subjects , but the diets had no influence .
RESULTS	In contrast , the HFD produced pronounced reductions in skeletal muscle CB1-R and MAGL mRNA expression , whereas obesity did not affect muscular gene expression .
CONCLUSIONS	Weight-neutral changes in dietary fat intake can not explain excessive endocannabinoid availability in human obesity .
CONCLUSIONS	Obesity and dietary fat intake affect ECS gene expression in a tissue-specific manner .

###24463131
OBJECTIVE	To study protective effect of ulinastatin on perioperative cardiac function in elderly patients undergoing major gastrointestinal surgery .
METHODS	Sixty elderly patients ( 32 male and 28 female patients ) aged 60-82 years scheduled for major gastrointestinal surgery were randomized into ulinastatin group and control group .
METHODS	The patients in ulinastatin group received 210 ( 5 ) U ulinastatin rapidly administered via a intravenous pump immediately before operation with subsequent continuous infusion at the rate of 110 ( 5 ) U until the completion of surgery , and those in the control group received the same amount of saline instead .
METHODS	In both groups , the mean arterial pressure ( MAP ) , heart rate ( HR ) , left ventricular ejection fraction ( LVEF ) , and cardiac output ( CO ) were monitored immediately before surgery ( T0 ) and at 1 h ( T1 ) , 2 h ( T2 ) and 3 h ( T3 ) after the start of surgery .
METHODS	The total dopamine dose used was recorded at the end of surgery , and blood samples were collected at T0 and at 6 h ( T4 ) and 12 h ( T5 ) after the operation for determination of serum levels of cTn , CK-MB and BNP .
RESULTS	In both groups , MAP , LVEF and CO were significantly decreased at T2 and T3 ( P < 0.05 ) and serum levels of cTn , CK-MB and BNP significantly increased at T4 and T5 compared to those at T0 ( P < 0.05 ) .
RESULTS	Compared with the control group , the patients in ulinastatin group showed significantly higher MAP , LVEF and CO at T2 and T3 and lower serum levels of cTn , CK-MB and BNP at T4 and T5 .
CONCLUSIONS	Ulinastatin offers effective perioerative cardiac protection in elderly patients undergoing major gastrointestinal surgery .

###24973911
OBJECTIVE	To determine the 12-month cost-effectiveness of a collaborative care ( CC ) program for treating depression following coronary artery bypass graft ( CABG ) surgery versus physicians ' usual care ( UC ) .
METHODS	We obtained 12 continuous months of Medicare and private medical insurance claims data on 189 patients who screened positive for depression following CABG surgery , met criteria for depression when reassessed by telephone 2 weeks following hospitalization ( nine-item Patient Health Questionnaire 10 ) and were randomized to either an 8-month centralized , nurse-provided and telephone-delivered CC intervention for depression or to their physicians ' UC .
RESULTS	At 12 months following randomization , CC patients had $ 2068 lower but statistically similar estimated median costs compared to UC ( P = .30 ) and a variety of sensitivity analyses produced no significant changes .
RESULTS	The incremental cost-effectiveness ratio of CC was - $ 9889 ( - $ 11,940 to - $ 7838 ) per additional quality-adjusted life-year ( QALY ) , and there was 90 % probability it would be cost-effective at the willingness to pay threshold of $ 20,000 per additional QALY .
RESULTS	A bootstrapped cost-effectiveness plane also demonstrated a 68 % probability of CC `` dominating '' UC ( more QALYs at lower cost ) .
CONCLUSIONS	Centralized , nurse-provided and telephone-delivered CC for post-CABG depression is a quality-improving and cost-effective treatment that meets generally accepted criteria for high-value care .

###25230081
OBJECTIVE	To evaluate the relative pain and the relative amount of contact lens loss experienced using two different base curvatures ( BCs ) of the Acuvue Oasys bandage soft contact lens ( BSCL ) after photorefractive keratectomy ( PRK ) .
METHODS	One hundred forty patients undergoing PRK on either the Allegretto or the VISX laser at the Joint Warfighter Refractive Surgery Center in Lackland AFB , TX , were randomized to one of the two different BCs of the Acuvue Oasys BSCL : 8.4 or 8.8 mm .
METHODS	Patients were evaluated on postoperative days 1 and 4 during which they completed a survey rating absolute pain in each eye on a visual analog pain scale .
METHODS	Lens loss was recorded throughout the study .
RESULTS	Patients treated on the Allegretto laser preferred the 8.4-mm BC lens , whereas comfort after treatment on the VISX depended on corneal shape .
RESULTS	For VISX , patients with very flat corneas ( steep K 42 preoperative or 38 postoperatively ) preferred an 8.8-mm BC lens while patients with very steep corneas ( steep K > 45 preoperative or > 42 postoperative ) preferred an 8.4-mm BC lens , though these results were largely not statistically significant .
RESULTS	Patients who lost their lenses prematurely tended to be those whose corneal curvature did not match their contact lens BC .
CONCLUSIONS	Individuals treated with the Allegretto laser or individuals with more prolate corneas should likely be fit with an 8.4-mm BC Acuvue Oasys BSCL while individuals with more oblate corneas should likely be fit with an 8.8-mm BC lens to minimize postoperative pain and premature BSCL loss .

###25211749
OBJECTIVE	We tested the efficacy of a brief intervention to promote correct and consistent use of condoms among Black male youths attending sexually transmitted infection ( STI ) clinics in 3 southern US cities .
METHODS	In 2010 to 2012 , we screened ( n = 1102 ) and enrolled ( n = 702 ) youths aged 15 to 23 years who identified as Black and reported recent ( past 2 months ) sexual activity and randomized them to a private , brief , interactive intervention ( n = 349 ) or an attention-equivalent control condition ( n = 353 ) .
METHODS	Assessments occurred at baseline and 2 and 6 months after the intervention .
RESULTS	At 6 months , with adjustment for age and pretest nonequivalence of the outcome variable , an estimated odds ratio ( EOR ) of 1.63 ( 95 % confidence interval [ CI ] = 1.07 , 2.49 ; P = .02 ) indicated efficacy for correct condom use .
RESULTS	An adjusted generalized estimating equations model with both 2 - and 6-month condom use variables produced an EOR of 1.49 ( 95 % CI = 1.06 , 2.08 ; P = .02 ) .
RESULTS	We did not observe significant effects on chlamydia and gonorrhea incidence .
CONCLUSIONS	This brief intervention , delivered as part of STI clinical care , could help alleviate the disproportionate STI-HIV burden among young Black men .

###24276838
OBJECTIVE	Vaso-occlusive episodes ( VOEs ) are the most common complication of sickle cell disease in children .
OBJECTIVE	Treatment with magnesium seems to improve cellular hydration and may result in reduced vaso-occlusion .
OBJECTIVE	This study aimed to determine if intravenous ( IV ) magnesium sulfate ( MgSO4 ) reduces length of stay ( LOS ) in hospital , pain scores , and cumulative analgesia when compared with placebo .
METHODS	Randomized , double-blind , placebo-controlled trial in children aged 4 to 18 years requiring admission to hospital with a sickle cell disease VOE requiring IV analgesia .
METHODS	Participating children received IV MgSO4 ( 100 mg/kg ) every 8 hours or placebo in addition to standard therapy .
METHODS	We used a t test or Mann-Whitney test ( continuous variables ) , Fisher 's exact test , or 2 test ( frequencies ) .
METHODS	P values were considered significant if < .05 , and 95 % confidence intervals were calculated for the difference between groups .
RESULTS	One hundred six children were randomly assigned to the study , and 104 were included .
RESULTS	Fifty-one ( 49 % ) received MgSO4 .
RESULTS	Children 's mean age was 12.4 years ( range : 4-18 years ; SD : 3.8 years ) , and 56 ( 54 % ) were females .
RESULTS	There was no significant difference in the primary outcome measure , LOS in hospital , with a mean of 132.6 and 117.7 hours in the MgSO4 and placebo groups , respectively ( P = .41 ) .
RESULTS	There was no significant difference between groups for the secondary outcomes of mean pain scores ( 4.9 2.6 vs 4.8 2.6 , respectively ; P = .92 ) or analgesic requirements ( continuous morphine infusion [ P = .928 ] , boluses of IV morphine [ P = .82 ] , acetaminophen [ P = .34 ] , ibuprofen [ P = .15 ] , naproxen [ P = .10 ] ) .
RESULTS	Only minor adverse events were recorded in both groups .
RESULTS	Pain at the infusion site was more common in the MgSO4 group .
CONCLUSIONS	IV MgSO4 was well tolerated but had no effect on the LOS in hospital , pain scores , or cumulative analgesia use in admitted children with a VOE .

###25262252
BACKGROUND	Detecting paroxysmal atrial fibrillation ( AF ) in patients with ischemic strokes presenting in sinus rhythm is challenging because episodes are often short , occur randomly , and are frequently asymptomatic .
BACKGROUND	If AF is detected , recurrent thromboembolism can be prevented efficiently by oral anticoagulation .
BACKGROUND	Numerous uncontrolled studies using various electrocardiogram ( ECG ) devices have established that prolonged ECG monitoring increases the yield of AF detection , but most established procedures are time-consuming and costly .
BACKGROUND	The few randomized trials are mostly limited to cryptogenic strokes .
BACKGROUND	The optimal method , duration , and patient selection remain unclear .
BACKGROUND	Repeated prolonged continuous Holter ECG monitoring to detect paroxysmal AF within an unspecific stroke population may prove to be a widely applicable , effective secondary prevention strategy .
METHODS	Find-AFRANDOMISED is a randomized and controlled prospective multicenter trial .
METHODS	Four hundred patients 60 years or older with manifest ( symptoms 24 hours or acute computed tomography/magnetic resonance imaging lesion ) and acute ( symptoms 7 days ) ischemic strokes will be included at 4 certified stroke centers in Germany .
METHODS	Those with previously diagnosed AF/flutter , indications/contraindications for oral anticoagulation , or obvious causative blood vessel pathologies will be excluded .
METHODS	Patients will be randomized 1:1 to either enhanced and prolonged Holter ECG monitoring ( 10 days at baseline and after 3 and 6 months ) or standard of care ( 24-hour continuous ECG monitoring , according to current stroke guidelines ) .
METHODS	All patients will be followed up for at least 12 months .
RESULTS	The primary end point is newly detected AF ( 30 seconds ) after 6 months , confirmed by an independent adjudication committee .
RESULTS	We plan to complete recruitment in autumn 2014 .
RESULTS	First results can be expected by spring 2016 .

###24293773
OBJECTIVE	Newcomers at high altitude ( > 3,000 m ) experience periodic breathing , sleep disturbances , and impaired cognitive performance .
OBJECTIVE	Whether similar adverse effects occur at lower elevations is uncertain , although numerous lowlanders travel to moderate altitude for professional or recreational activities .
OBJECTIVE	We evaluated the hypothesis that nocturnal breathing , sleep , and cognitive performance of lowlanders are impaired at moderate altitude .
METHODS	Randomized crossover trial .
METHODS	University hospital at 490 m , Swiss mountain villages at 1,630 m and 2,590 m.
METHODS	Fifty-one healthy men , median ( quartiles ) age 24 y ( 20-28 y ) , living below 800 m.
METHODS	Studies at Zurich ( 490 m ) and during 4 consecutive days at 1,630 m and 2,590 m , respectively , 2 days each .
METHODS	The order of altitude exposure was randomized .
METHODS	Polysomnography , psychomotor vigilance tests ( PVT ) , the number back test , several other tests of cognitive performance , and questionnaires were evaluated .
RESULTS	The median ( quartiles ) apnea-hypopnea index at 490 m was 4.6 / h ( 2.3 ; 7.9 ) , values at 1,630 and 2,590 m , day 1 and 2 , respectively , were 7.0 / h ( 4.1 ; 12.6 ) , 5.4 / h ( 3.5 ; 10.5 ) , 13.1 / h ( 6.7 ; 32.1 ) , and 8.0 / h ( 4.4 ; 23.1 ) ; corresponding values of mean nocturnal oxygen saturation were 96 % ( 95 ; 96 ) , 94 % ( 93 ; 95 ) , 94 % ( 93 ; 95 ) , 90 % ( 89 ; 91 ) , 91 % ( 90 ; 92 ) , P < 0.05 versus 490 m , all instances .
RESULTS	Slow wave sleep on the first night at 2,590 m was 21 % ( 18 ; 25 ) versus 24 % ( 20 ; 27 ) at 490 m ( P < 0.05 ) .
RESULTS	Psychomotor vigilance and various other measures of cognitive performance did not change significantly .
CONCLUSIONS	Healthy men acutely exposed during 4 days to hypoxemia at 1,630 m and 2,590 m reveal a considerable amount of periodic breathing and sleep disturbances .
CONCLUSIONS	However , no significant effects on psychomotor reaction speed or cognitive performance were observed .
BACKGROUND	Clinicaltrials.gov : NCT01130948 .

###25464897
BACKGROUND	Low-volume bowel preparations have been shown to provide an equivalent cleansing effect as that of a standard 4 L polyethylene glycol .
BACKGROUND	However , studies comparing the efficacy of low-volume bowel preparations are few , and the results have been controversial .
BACKGROUND	This study aimed to compare the bowel cleansing quality and tolerability between sodium picosulfate/magnesium citrate and polyethylene glycol with ascorbic acid .
METHODS	A randomized study was performed with two hundred outpatients who were prospectively enrolled .
METHODS	The Boston Bowel Preparation Scale and the Aronchick scale were used to evaluate the bowel cleansing quality , and bubble scoring was also performed to back up both results .
METHODS	To investigate patients ' preferences and tolerability , a questionnaire was administered .
RESULTS	Sodium picosulfate/magnesium citrate was not inferior to polyethylene glycol with ascorbic acid in terms of successful bowel preparation ( 6 Boston scale score : 80 % vs. 82 % ; p = 0.718 , adequate Aronchick grade : 93 % vs. 96 % ; p = 0.352 ) .
RESULTS	In addition , sodium picosulfate/magnesium citrate caused fewer gastrointestinal symptoms , and tasted better than polyethylene glycol with ascorbic acid .
CONCLUSIONS	Sodium picosulfate/magnesium citrate was not inferior to polyethylene glycol with ascorbic acid in cleansing efficacy , and was found to have higher tolerability .

###24746581
BACKGROUND	Multimorbidity and declining performance in elderly cancer patients may result in less treatment benefit .
BACKGROUND	We investigated whether age is a predictor for pain response and quality of life ( QoL ) after radiotherapy in patients with painful bone metastases .
METHODS	The database of the Dutch Bone Metastasis Study was used ( 1996-1999 ) .
METHODS	1157 patients , irradiated for painful bone metastases , rated their pain , QoL-domains and overall health at baseline and during follow-up .
METHODS	Response was calculated taking into account changes in pain score and medication .
METHODS	Patients were grouped into three age cohorts : A : < 65 ( n = 520 ) , B : 65-74 ( n = 410 ) and C : 75years ( n = 227 ) .
RESULTS	No significant difference existed in pain response between cohorts : 78 % in cohort A , 74 % in B and 67 % in C.
RESULTS	When assessing baseline QoL , a significant difference in activity level was noticed , with more impairment in elderly compared to younger patients ( C versus B ( p = 0.01 ) , C versus A ( p < 0.001 ) ) .
RESULTS	Other QoL-domains were similar at baseline and during follow-up among cohorts .
RESULTS	A pain response was significantly associated with improvement of health-related QoL ( OR 3.74 , 95 % CI 2.66-5 .25 ) .
CONCLUSIONS	The majority of elderly patients with painful bone metastases responded to radiotherapy and showed comparable overall QoL compared to their younger counterparts .
CONCLUSIONS	Age is not a predictor for pain response or QoL .

###24448329
OBJECTIVE	to investigate the efficacy of zinc supplementation in chronic prostatitis treatment .
METHODS	present randomized clinical trial was conducted on 120 patients with diagnosis of chronic prostatitis ( IIIA NIH ) after preliminary evaluation and ruling out other conditions .
METHODS	The study group received oral zinc sulfate 220 mg daily as capsule without any other supplements .
METHODS	The control group received placebo .
METHODS	Subjects were examined for NIH-CPSI scores every 4 weeks for 12 weeks .
RESULTS	101 subjects completed the study .
RESULTS	There were no statistically significant differences in scores and sub-scores of NIH-CPSI between groups before intervention .
RESULTS	Decline in the score and sub-scores were more prominent in case group after beginning of the study ; though the differences were not statistically significant .
RESULTS	Furthermore , the differences in total score and pain score at 12 weeks follow was statistically significant ( p = 0.003 and p = 0.02 , respectively ) .
CONCLUSIONS	zinc supplements may benefit in management of patients with chronic prostatitis NIH-IIIA .
CONCLUSIONS	It can be attributable to anti-bacterial and immuno-modulatory functions of organic zinc in the body .

###24952697
OBJECTIVE	This study sought to examine the effect of statin therapy hospitalizations for heart failure ( HFH ) in patients in the CORONA ( Controlled Rosuvastatin Multinational Trial in Heart Failure ) trial .
BACKGROUND	HFH is an important , frequently recurrent event .
BACKGROUND	Conventional time-to-first event analyses do not take account repeat events .
BACKGROUND	We used a number of statistical approaches to examine the effect of treatment on first and repeat HFH in the CORONA trial .
METHODS	In the CORONA trial , 5,011 patients 60 years of age with chronic New York Heart Association functional classes II to IV systolic heart failure resulting from ischemia were randomized to receive rosuvastatin or placebo .
METHODS	Poisson , Andersen-Gill , and negative binomial methods ( NB ) were used to analyze the effect of rosuvastatin on HFH , and the NB and a parametric joint frailty model ( JF ) were used to examine this effect while accounting for the competing risk of cardiovascular ( CV ) death .
METHODS	Rosuvastatin/placebo rate ratios were calculated , both unadjusted and adjusted .
RESULTS	A total of 1,291 patients had 1 or more HFH ( 750 of these had a single HFH only ) , and there were a total of 2,408 HFHs .
RESULTS	The hazard ratio for the conventional time-to-first event analysis for HFH was 0.91 ( 95 % confidence interval [ CI ] : 0.82 to 1.02 , p = 0.105 ) .
RESULTS	In contrast , the NB on repeat hospitalizations gave an unadjusted RR ( RR ) for HFH of 0.86 ( 95 % CI : 0.75 to 0.99 , p = 0.030 ) , adjusted 0.82 ( 95 % CI : 0.72 to 0.92 , p = 0.001 ) , and after including CV death as the last event , adjusted RR of 0.85 ( 95 % CI : 0.77 to 0.94 , p = 0.001 ) .
RESULTS	The JF gave an adjusted RR of 0.82 ( 95 % CI : 0.73 to 0.92 , p = 0.001 ) .
RESULTS	Similar results were found in analyses of all CV hospitalizations and all-cause hospitalizations .
CONCLUSIONS	When repeat events were included , rosuvastatin was shown to reduce the risk of HFH by approximately 15 % to 20 % , equating to approximately 76 fewer admissions per 1,000 patients treated over a median 33 months of follow-up .
CONCLUSIONS	Including repeat events could increase the ability to detect treatment effects in heart failure trials .

###24835760
OBJECTIVE	To determine agreement between spectral-domain ( SD ) and time-domain ( TD ) optical coherence tomography ( OCT ) image assessments by certified readers in eyes treated for neovascular age-related macular degeneration ( AMD ) .
METHODS	Cross-sectional study within the Comparison of AMD Treatments Trials ( CATT ) .
METHODS	During year 2 of CATT , 1213 pairs of SD OCT and TD OCT scans were compared from a subset of 384 eyes .
METHODS	Masked readers independently graded OCT scans for presence of intraretinal fluid ( IRF ) , subretinal fluid ( SRF ) , and sub-retinal pigment epithelium ( RPE ) fluid and performed manual measurements of retinal , SRF , and subretinal tissue complex thicknesses at the foveal center .
METHODS	Presence of fluid was evaluated with percent agreement , coefficients with 95 % confidence intervals ( CIs ) , and McNemar tests .
METHODS	Thickness measurements were evaluated with mean difference ( ) 95 % limits of agreement and intraclass correlation coefficients ( ICCs ) with 95 % CIs .
RESULTS	Between SD OCT and TD OCT , agreement on presence of any fluid was 82 % ( = 0.46 ; 95 % CI , 0.40-0 .52 ) , with 5 % more SD OCT scans demonstrating fluid ( P < 0.001 ) .
RESULTS	Agreement on presence of SRF was 87 % and sub-RPE fluid was 80 % , with more SD OCT scans demonstrating fluid ( both P < 0.001 ) .
RESULTS	Agreement on IRF was 73 % ( = 0.47 ; 95 % CI , 0.42-0 .52 ) , with 6 % more TD OCT scans demonstrating fluid ( P < 0.001 ) .
RESULTS	Between SD OCT and TD OCT , mean thickness of the retina was = 567 m , SRF was = 1.535 m , and subretinal tissue complex was = 586 m. Thickness measurements were reproducible for retina ( ICC = 0.84 ; 95 % CI , 0.83-0 .86 ) , SRF ( ICC = 0.88 ; 95 % CI , 0.86-0 .89 ) , and subretinal tissue complex ( ICC = 0.91 ; 95 % CI , 0.89-0 .92 ) , with 25-m difference in these measurements in 71 % , 94 % , and 61 % of paired scans , respectively .
CONCLUSIONS	Agreement on fluid presence and manual thickness measurements between paired scans from each OCT modality was moderate , providing a reasonable basis to compare CATT results with future SD OCT-based trials .
CONCLUSIONS	Fluid was detected 5 % more frequently with SD OCT , which may increase frequency of fluid-based treatment .
CONCLUSIONS	Lower-resolution and artifactual interpretation of dark areas as cystoid edema may explain the greater frequency of IRF detected with TD OCT. .

###24282511
OBJECTIVE	To evaluate the cost-effectiveness of post-diagnosis dementia treatment and coordination of care by memory clinics compared to general practitioners ' care .
METHODS	A multicentre randomised trial with 175 community dwelling patients newly diagnosed with mild to moderate dementia , and their informal caregivers , with twelve months ' follow-up .
METHODS	Cost-effectiveness was evaluated from a societal point of view and presented as incremental cost per quality adjusted life year .
METHODS	To establish cost-effectiveness , a cost-utility analysis was conducted using utilities based on the EQ-5D .
METHODS	Uncertainty surrounding the incremental cost-effectiveness ratio ( difference in costs divided by difference in effects ) was calculated by bootstrapping from the original data .
RESULTS	Compared to general practitioners ' care , treatment by the memory clinics was on average 1024 ( 95 % CI : -7723 to 5674 ) cheaper , and showed a non-significant decrease of 0.025 ( 95 % CI : -0.114 to 0.064 ) quality adjusted life years .
RESULTS	The incremental cost-effectiveness point estimate from the bootstrap simulation was 41 442 per QALY lost if one would use memory clinic care instead of general practitioner care .
CONCLUSIONS	No evidence was found that memory clinics were more cost-effective compared to general practitioners with regard to post-diagnosis treatment and coordination of care of patients with dementia in the first year after diagnosis .
BACKGROUND	ClinicalTrials.gov NCT00554047 .

###24983446
OBJECTIVE	Methotrexate ( MTX ) is recognised as the cornerstone of treatment for rheumatoid arthritis .
OBJECTIVE	For some patients , oral MTX demonstrates variable bioavailability , especially at higher doses .
OBJECTIVE	Such concerns may be mitigated by subcutaneous ( SC ) MTX administration .
OBJECTIVE	This study investigated the relative bioavailability , safety , and tolerability of MTX administered either by SC injection with a prefilled autoinjector pen ( MTX pen ) or orally .
METHODS	This single-centre , open-label , randomised , 2-period , 2-sequence , single-dose , crossover study enrolled healthy subjects aged 18 to 55 years into 1 of 4 dose groups ( 7.5 mg , 15 mg , 22.5 mg , and 30 mg ) , where they received a single dose of SC MTX and of the oral MTX tablets .
METHODS	Blood samples were collected from subjects predose and at prespecified time points postdose for pharmacokinetic analyses .
METHODS	Adverse events ( AEs ) were recorded to assess differences in safety and tolerability .
RESULTS	Bioavailability , as measured by maximum plasma concentrations ( Cmax ) and area under the plasma-concentration curves ( AUC0-t ) , was generally higher with the SC MTX pen compared with oral administration for all dose groups .
RESULTS	AUC0-t ratios increased with ascending doses ; Cmax ratios did not increase .
RESULTS	A total of 80 AEs were reported in 35/62 subjects ; none were severe .
RESULTS	Differences in the safety profiles were related to the route of administration .
RESULTS	Single administrations with the MTX pen were well tolerated at the injection site .
CONCLUSIONS	Single-dose administration with the SC MTX pen resulted in a higher relative bioavailability compared with oral administration .
CONCLUSIONS	SC MTX pen administration was associated with fewer gastrointestinal AEs than oral MTX .

###24997616
BACKGROUND	Degenerative spondylolisthesis is a well-recognized source of low back pain mainly induced by facet joint pain .
BACKGROUND	Pulsed radiofrequency ( PRF ) allows heat dissipation , thus producing a temporary injury that affects only type C fibers responsible for pain conduction .
OBJECTIVE	We attempted to test whether PRF is a better choice for facet pain due to spondylolisthesis compared to routine steroid injection .
METHODS	Patients were randomly assigned to one of two groups : group one received pulsed RF , and group 2 received injection by steroids ( triamcinolone ) and bupivacaine .
METHODS	Multiple outcome measures were utilized which included the numeric rating scale ( NRS ) , the Oswestry Disability Index ( ODI ) , satisfaction status , and analgesic intake with assessment at 3 , 6 , and 12 months post-treatment .
METHODS	Significant pain relief was defined as 50 % or more , whereas significant improvement in disability score was defined as reduction of 40 % or more .
RESULTS	Eighty patients were enrolled in the study and were divided into the two groups of study .
RESULTS	PRF significantly reduced NRS at 6-month follow-up compared to steroid + bupivacaine .
RESULTS	75.6 14.3 % at pre-treatment and 19.3 9.5 % at 6 months ( p = 0.001 ) in PRF group .
RESULTS	The mean ODI is depicted in two groups of study ( Fig. 1 ) .
RESULTS	Interestingly , ODI % was significantly lower in PRF group at 12 weeks and 6 months compare to steroid + bupivacaine group ( p = 0.022 and 0.03 , respectively ) , but it was not significantly different at 6 weeks ( p = 0.31 ) .
RESULTS	Proportion of patients who did not require analgesics were significantly higher in PRF group compared to other group ( p = 0.001 ) in Log-rank ( Mantel-Cox ) test .
CONCLUSIONS	Our results demonstrated that the application of PRF might be more effective than steroid and bupivacaine injection in decreasing back pain due to degenerative facet pain and improvement in function of patients .

###25487172
OBJECTIVE	To evaluate if ibuprofen 800mg reduces pain with intrauterine device ( IUD ) insertion among U.S. women .
METHODS	We conducted a randomized , double-blind , placebo-controlled trial of women undergoing IUD insertion approximately 2-6weeks following first-trimester uterine aspiration .
METHODS	Subjects were randomized to receive ibuprofen 800mg or placebo 30-45min prior to IUD insertion .
METHODS	A 100-mm visual analog scale ( VAS ) was administered to measure pain after speculum insertion ( baseline ) and immediately following IUD insertion .
RESULTS	A total of 202 women were enrolled , with 101 randomized to each group ( ibuprofen or placebo ) .
RESULTS	Sociodemographic characteristics and baseline VAS scores were similar between groups .
RESULTS	The median pain score with IUD insertion was 41.5 mm in the placebo group and 38.0 mm in the ibuprofen group ( p = .50 ) .
RESULTS	Mean and median pain scores did not differ between placebo and ibuprofen when nulliparous and parous women were analyzed independently .
RESULTS	Overall , median pain scores were 17.5 mm higher in nulliparous women than parous women ( p = .004 ) .
RESULTS	Median pain scores did not differ by age , IUD-type , history of dysmenorrhea or time since aspiration .
CONCLUSIONS	Administration of ibuprofen 800mg prior to IUD insertion does not reduce pain associated with the procedure for U.S. women .
CONCLUSIONS	Overall , nulliparous women report more pain with IUD insertion than multiparous women .

###24627256
OBJECTIVE	This prospective randomized controlled trial was conducted to compare the safety , tolerability and outcome of early oral feeding vs. traditional feeding in patients undergoing elective open bowel surgery .
METHODS	A total of 120 consecutive patients who underwent elective open bowel surgeries were randomized into either early feeding ( n = 60 ) or traditional feeding group ( n = 60 ) .
METHODS	Patients in the early feeding group were started on oral fluids on post-operative day 1 , while those in the traditional feeding group were started orals after the resolution of ileus .
METHODS	Patient characteristics , surgical procedures , co-morbidity , first flatus , first defecation , time of starting solid diet , complications and length of hospitalization were assessed between the two groups .
RESULTS	The two groups were similar in demographic and baseline data .
RESULTS	The number of days to first flatus ( p < 0.0001 ) , first defecation ( p < 0.0001 ) , length of post-operative stay ( p = 0.011 ) and time of starting solid diet ( p < 0.0001 ) were significantly earlier in the early feeding group .
RESULTS	Anastomotic leak , wound infection , fever , vomiting , abdominal distention and other complications were similar .
RESULTS	Multivariate analysis showed that patients in the early oral feeding group were discharged 3.4 days earlier ( p = 0.037 ) .
CONCLUSIONS	In patients undergoing elective open bowel surgeries , early post-operative feeding is safe , is well tolerated and reduces the length of hospitalization .

###25365893
OBJECTIVE	The aim of the present study was to determine the effectiveness of parent manipulation on newborns with postural clubfoot , as compared to newborns that receive no treatment in a randomized controlled trial .
METHODS	Ninety-two healthy newborns , including 40 boys and 52 girls , ( 169 postural clubfeet , including 77 with bilaterally involvement ) were included and categorized into two groups by simple randomization using the sealed opaque envelope technique .
METHODS	In Group A , the parent manipulation group , there were 14 boys and 33 girls in 85 postural clubfeet with 38 bilateral involvements .
METHODS	Manipulations were performed at least 20 times per day and the stimulation of the newborn 's foot / feet byparent finger was performed at least 100 times per day .
METHODS	In Group B , the group of newborns receiving no treatment , there were 26 boys and 19 girls in 84 postural clubfeet with 39 bilateral involvements .
METHODS	The follow-up periods for both groups were one , three , and four months after starting the manipulation .
METHODS	The success of the manipulation was measured by the foot appearance , which was normally performed by physical examination .
RESULTS	A comparison of the characteristics of newborns and parents in both groups showed no statistical differences , except the sex of the newborn .
RESULTS	All newborns in both groups were one to six days old .
RESULTS	The success rate after 4 months of manipulation in Group A was 71.8 % , but it was 81 % in Group B with no manipulation ; results indicate no statistically significant difference ( p = 0.16 ) .
RESULTS	The severity of the postural clubfeet indicated no statistical difference in the results of either group ( p = 0.3 ) .
RESULTS	All cases were followed up at one year with 14 % of the studyparticipants dropping out in Group A and 11 % dropping out of the study in Group B. All postural clubfeet disappeared in every case within one year of birth except one case in Group A that required casting and one case in Group B that required a prescription for orthopaedic shoes .
CONCLUSIONS	No clinical or statistical differences were found between newborns who received parent manipulation for the treatment of postural clubfoot and newborns who received no treatment .
CONCLUSIONS	Spontaneous recovery occurred in most of the cases within four months of birth or not more than one year after birth .

###24614832
OBJECTIVE	The aim of this trial was to investigate the effect of therapeutic microwave diathermy ( MD ) on pain , disability , trunk muscle strength , walking performance , mobility , quality of life ( QOL ) , and depression in the patients with chronic low back pain ( CLBP ) .
METHODS	A total of 39 patients were included in this study .
METHODS	The patients were randomized into two groups .
METHODS	Group 1 ( n = 19 ) received MD treatment and exercises .
METHODS	Group 2 ( n = 20 ) was given only exercises .
METHODS	The pain ( visual analog scale ) , disability ( Oswestry Disability Questionnaire and pain disability index ) , walking performance ( 6 minute walking test , 6MWT ) , depression and QOL ( Short Form 36 ) of all participants were evaluated .
METHODS	Patients were assessed before treatment ( BT ) , after treatment ( AT ) , and at a 1-month follow-up ( F ) .
RESULTS	The patients with CLBP in each group had significant improvements in pain , disability , muscle strength , endurance , 6MWT , mobility , QOL , and depression AT and F when compared with their initial status .
RESULTS	There was no statistically significant difference between the groups regarding the change scores between AT-BT test and F-BT test .
CONCLUSIONS	Since a 2,450-MHz MD showed no beneficial effects on clinical parameters , exercise program could be preferable for the treatment of patients with CLBP alone .

###25624756
BACKGROUND	Exercise intolerance is a common development in patients with chronic obstructive pulmonary disease ( COPD ) .
BACKGROUND	There is little data on the use of an isolated program using vibration platform training on functional capacity in these patients , which is an area that deserves investigation .
OBJECTIVE	To investigate the effect of training on a vibrating platform ( whole-body vibration [ WBV ] ) on functional performance and quality of life of subjects with COPD .
METHODS	A randomized controlled crossover pilot study with eleven subjects with COPD ( forced expiratory volume in 1 second [ FEV1 ] % predicted = 14.6311.14 ; forced vital capacity [ FVC ] % predicted = 48.8415.21 ; FEV1/FVC = 47.3911.63 ) underwent a 12-week WBV training program .
METHODS	Participants were randomized into the intervention group ( IG ) undergoing three sessions per week for a total of 12 weeks and control group ( CG ) without intervention .
METHODS	We evaluated the 6-minute walk test ( 6MWT ) , distance walked ( DW ) , duration of the walk ( TW ) , and index of perceived exertion ( IPE ) , quality of life using St George 's Respiratory Questionnaire ( SGRQ ) and developed a 12-week program of training on a vibrating platform .
RESULTS	The mean age was 62.918.82 years old ( 72.7 % male ) .
RESULTS	The DW increased at the end of training with a difference between groups of 75 m ; all domains of the SGRQ improved at the end of training .
RESULTS	The effect size Cohen 's d ranged from small to large for all the measured results .
CONCLUSIONS	These preliminary results suggest that WBV may potentially be a safe and feasible way to improve functional capacity in the 6MWT of patients with COPD undergoing a training program on the vibrating platform as well as in all domains of the SGRQ quality of life .
CONCLUSIONS	However , further studies with a larger number of patients are needed to establish the long-term effect on functional capacity and quality of life in these patients .

###25623343
OBJECTIVE	Insomnia is prevalent among patients with knee osteoarthritis ( OA ) .
OBJECTIVE	Research indicates that sleep disruption may amplify clinical pain by altering central pain modulation , suggesting that treatment of insomnia may improve pain .
OBJECTIVE	The aims of this study were to evaluate the efficacy of cognitive-behavioral therapy for insomnia ( CBT-I ) in patients with knee OA , to determine whether improvements in sleep predict reduced pain , and to determine whether alterations in pain modulation mediate improvements in clinical pain .
METHODS	We conducted a randomized , double-blind , active placebo-controlled clinical trial of CBT-I in 100 patients with knee OA and insomnia ( meanSD age 59.49.5 years ) .
METHODS	Patients were randomized ( 1:1 ) to receive either 8 sessions of CBT-I or behavioral desensitization ( placebo ) .
METHODS	We conducted in-home polysomnography ( PSG ) , diary assessment , and sensory tests of pain modulation at baseline , posttreatment , 3 months , and 6 months .
RESULTS	Intent-to-treat analyses demonstrated substantial improvement in sleep in both groups of patients .
RESULTS	Patients in the CBT-I group had significantly greater reductions in wake after sleep onset ( WASO ) , as measured by patient diary and PSG .
RESULTS	Patients in both groups reported significant and comparable reductions in pain over 6 months , with one-third reporting a 30 % reduction in pain severity .
RESULTS	Baseline-to-posttreatment reductions in WASO as measured by diary and PSG predicted subsequent decreases in clinical pain .
RESULTS	This effect was significantly greater for CBT-I compared with behavioral desensitization .
RESULTS	No significant changes in laboratory measures of pain modulation were observed .
CONCLUSIONS	Compared with active placebo , CBT-I was efficacious in reducing sleep maintenance insomnia .
CONCLUSIONS	CBT-I decreased clinical pain , but not pain modulation , suggesting that it has the potential to augment pain management in knee OA .
CONCLUSIONS	Future work is needed to identify the mechanisms by which improved sleep reduces clinical pain .

###24321619
OBJECTIVE	The aim of our study was to characterize the neurophysiologic outcomes in a randomized clinical trial comparing local corticosteroid injection and decompressive surgery in idiopathic carpal tunnel syndrome .
METHODS	Clinical and neurophysiologic assessments were done at baseline and 12 months after treatment .
METHODS	Four parameters were evaluated in the nerve conduction study ( NCS ) : distal motor latency , motor amplitude , sensory conduction velocity and sensory amplitude .
METHODS	Statistic signification was established by the Student 's t test , independent and paired samples , and Mann-Whitney test .
METHODS	Repeated measures analysis of variance was used by the three domains of symptoms .
METHODS	Correlations between the changes showed in clinical parameters and those evidenced by electromyography were calculated by the Pearson 's test .
RESULTS	Both groups of therapy were comparable at baseline .
RESULTS	In 95 wrists , a second NCS was done 12 months post-treatment .
RESULTS	Although clinical outcome improved in a similar way in both groups , we found statistically significant improvement in three ( distal motor latency , sensory conduction velocity and sensory amplitude ) of four neurophysiologic parameters only in the surgery group , when compared to baseline values .
CONCLUSIONS	Although local corticosteroid injection and decompressive surgery are clinically effective in reducing symptoms of carpal tunnel syndrome , only surgery results in an improvement of the neurophysiologic parameters , at 12-months follow-up .
CONCLUSIONS	Only decompressive surgery allows resolution of neurophysiologic changes .
CONCLUSIONS	The symptoms of the syndrome are resolved with corticosteroid injections .

###25958714
OBJECTIVE	To compare changes of heart rate and blood pressure in patients that underwent LMA anesthesia with VIMA or TIVA technique .
METHODS	A hundred healthy patients , age 16 to 60 years were enrolled .
METHODS	They were randomized into two groups .
METHODS	Patients in group V ( VIMA ) were induced with 8 % sevoflurane until loss of eyelash reflexes then controlled ventilation for five minutes before LMA insertion .
METHODS	Group T ( TIVA ) patients were given propofol to reach the affected site concentration of eight mcg/mlfor the LMA insertion .
METHODS	Bloodpressure and heart rate were recorded before induction , immediately before and after LMA insertion then every two minutes until surgical incision .
RESULTS	Decreased SBP from baseline in group T was significantly more than group V in each period of time ( D1-D7 ) .
RESULTS	DBP in group T decreased more than group V significantly only at eight and ten minutes after LMA insertion .
RESULTS	The incidence of decreasing SBP > 20 % from baseline was more significant in group T than group V. No significant difference of changed HR was found .
RESULTS	Coughing during LMA insertion occurred in eight patients ( 16 % ) in group T and in three patients ( 6 % ) in group V ( p = 0.11 ) .
CONCLUSIONS	Induction with propofol by effective site concentration of eight mcg/ml significantly decreased SBP more than with 8 % sevoflurane .
CONCLUSIONS	Both techniques provided smooth LMA insertion without serious complication .

###25588587
BACKGROUND	Postpartum haemorrhage can lead to iron deficiency with and without anaemia , the clinical consequences of which include physical fatigue .
BACKGROUND	Although oral iron is the standard treatment , it is often associated with gastrointestinal side effects and poor compliance .
BACKGROUND	To date , no published randomised controlled studies have compared the clinical efficacy and safety of standard medical care with intravenous administration of iron supplementation after postpartum haemorrhage.The primary objective of this study is to compare the efficacy of an intravenous high single-dose of iron isomaltoside 1000 with standard medical care on physical fatigue in women with postpartum haemorrhage .
METHODS	In a single centre , open-labelled , randomised trial , women with postpartum haemorrhage exceeding 700 mL will be allocated to either a single dose of 1,200 mg of iron isomaltoside 1000 or standard medical care .
METHODS	Healthy parturients with a singleton pregnancy will be included within 48 hours after delivery.Participants will complete structured questionnaires that focus on several dimensions of fatigue and mental health ( Multidimensional Fatigue Inventory , Edinburgh Postnatal Depression Scale and the Postpartum Questionnaire ) , at inclusion and at follow-up visits after three days , one week , three weeks , eight weeks , and 12 weeks postpartum .
METHODS	The primary endpoint is the aggregated change in physical fatigue score within 12 weeks postpartum , as measured by a subscale of the Multidimensional Fatigue Inventory .
METHODS	The primary objective will be considered to have been met if an intravenous high single dose of iron isomaltoside 1000 is shown to be superior to standard medical care in women after postpartum haemorrhage regarding physical fatigue.For claiming superiority , we set the minimal clinically relevant difference between the mean scores at 1.8 , and the assumed standard deviation at 4.2 .
METHODS	Hence , 87 participants per treatment group are needed in order to demonstrate superiority ; to provide an extra margin for missing data and dropouts , 200 women will be included .
CONCLUSIONS	The study will provide evidence on relevant clinical outcomes beyond biochemical parameters for intravenous iron isomaltoside 1000 compared to standard medical care in women after postpartum haemorrhage .
BACKGROUND	This trial is registered with Clinicaltrials.gov ( identifier : NCT01895218 ) on 26 June 2013 .

###24248184
BACKGROUND	The effect of vitamin D on muscle strength in adults is not established .
OBJECTIVE	Our objective was to test whether vitamin D supplementation increases muscle strength and power compared with placebo .
METHODS	We conducted a randomized , double-blind , placebo-controlled trial .
METHODS	The setting was immigrants ' activity centers .
METHODS	Two hundred fifty-one healthy adult males and females aged 18-50 years with non-Western immigrant background performed the baseline test and 86 % returned to the follow-up test .
METHODS	Sixteen weeks of daily supplementation with 25 g ( 1000 IU ) vitamin D3 , 10 g ( 400 IU ) vitamin D3 , or placebo .
METHODS	Difference in jump height between pre - and postintervention .
METHODS	Secondary outcomes were differences in handgrip strength and chair-rising test .
RESULTS	Percentage change in jump height did not differ between those receiving vitamin D ( 25 or 10 g vitamin D3 ) and those receiving placebo ( mean difference -1.4 % , 95 % confidence interval : -4.9 % to 2.2 % , P = .44 ) .
RESULTS	No significant effect was detected in the subgroup randomized to 25 g vitamin D or in other preplanned subgroup analyses nor were there any significant differences in handgrip strength or the chair-rising test .
RESULTS	Mean serum 25-hydroxyvitamin D3 concentration increased from 27 to 52 nmol/L and from 27 to 43 nmol/L in the 25 and 10 g supplementation groups , respectively , whereas serum 25-hydroxyvitamin D3 did not change in the placebo group .
CONCLUSIONS	Daily supplementation with 25 or 10 g vitamin D3 for 16 weeks did not improve muscle strength or power measured by the jump test , handgrip test , or chair-rising test in this population with low baseline vitamin D status .

###24994571
OBJECTIVE	To evaluate the influence of stroke volume variation ( SVV ) - based goal-directed therapy ( GDT ) on splanchnic organ functions and postoperative complications in orthopedic patients .
METHODS	Eighty patients scheduled for major orthopedic surgery under general anesthesia were randomly allocated to one of two equal groups to receive either intraoperative volume therapy guided by SVV ( GDT ) or standard fluid management ( control ) .
METHODS	In the SVV group , patients received colloid boluses of 4 ml/kg to maintain an SVV < 10 % when in the supine position or an SVV < 14 % if prone .
METHODS	In the control group , fluids were given to maintain a mean arterial pressure > 65 mm Hg , a heart rate < 100 bpm , a central venous pressure of 8-14 mm Hg , and a urine output > 0.5 ml/kg/h .
METHODS	Intraoperative organ perfusion , hemodynamic data , hospitalization , postoperative complications , and mortality were recorded .
RESULTS	The heart rate at the end of surgery was significantly lower ( p < 0.05 ) , there were fewer hypotensive episodes ( p < 0.05 ) , the arterial and gastric intramucosal pH were higher ( p < 0.05 for both ) , the gastric intramucosal PCO2 was lower ( p < 0.05 ) , the intraoperative infused colloids and the total infused volume were lower ( p < 0.05 for both ) , and the postoperative time to flatus was shorter ( p < 0.05 ) in the GDT group than in the control group .
RESULTS	No differences in the length of hospital stay , complications , or mortality were found between the groups .
CONCLUSIONS	SVV-based GDT during major orthopedic surgery reduced the volume of the required intraoperative infused fluids , maintained intraoperative hemodynamic stability , and improved the perioperative gastrointestinal function .

###25004347
OBJECTIVE	To estimate the effectiveness of office-based bipolar radiofrequency ablation compared with thermal balloon ablation of the endometrium for the treatment of heavy menstrual bleeding at 5-year follow-up .
METHODS	A single blind randomized controlled trial was conducted in an office hysteroscopy clinic in a university teaching hospital .
METHODS	A total of 81 women were randomly allocated to either bipolar radiofrequency ablation or thermal balloon ablation in an office setting avoiding use of general anesthesia or conscious sedation .
METHODS	The primary outcome for the trial was amenorrhea at 6 months follow-up .
METHODS	In this planned secondary analysis , the main outcome measures were amenorrhea rates , patient satisfaction , health-related quality of life , and incidence of further uterine surgery at 5-year follow-up .
RESULTS	At 5-year follow-up , 59 ( 73 % ) women responded to postal questionnaires .
RESULTS	Amenorrhea was reported in 60 % of thermal balloon ablation and 62 % of bipolar radiofrequency ablation ( odds ratio [ OR ] 1.09 [ 0.38-3 .11 ] ) and satisfaction with treatment outcome in 96 % of thermal balloon ablation and 96 % of bipolar radiofrequency ablation ( OR 0.92 [ 0.05-25 .59 ] ) .
RESULTS	Further surgical intervention was needed in three of 29 ( 10 % ) women treated with bipolar radiofrequency ablation compared with four of 30 ( 13 % ) of women treated with thermal balloon ablation ( P = .7 ) .
RESULTS	There was no significant difference in either condition-specific or generic health-related quality-of-life measures .
CONCLUSIONS	There was no difference in the effectiveness of bipolar radiofrequency ablation and thermal balloon ablation performed in an office setting at 5-year follow-up .
BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT01124357 .
METHODS	I.

###24247022
BACKGROUND	Evidence supports a role of 42 receptors in Alzheimer 's disease ( AD ) .
METHODS	This Korean , multicenter , double-blind , two-period ( 6 weeks each ) , crossover study randomized participants to the order in which they received varenicline ( 1 mg twice daily ) and placebo .
METHODS	Assessments included AD Assessment Scale-Cognitive Subscale ( ADAS-Cog ) 75 , Neuropsychiatric Inventory ( NPI ) , adverse events ( AEs ) and Columbia-Suicide Severity Rating Scale ( C-SSRS ) .
RESULTS	For varenicline versus placebo ( n = 66 randomized ) , there was no significant difference in the week 6 least square ( LS ) mean ADAS-Cog 75 total score ( primary endpoint ; 18.07 vs. 18.49 ; p = 0.3873 ) and a slight worsening in the week 6 LS mean NPI ( 3.82 vs. 2.55 ; p = 0.0468 ) , primarily driven by decreased appetite/eating .
RESULTS	Common treatment-related AEs were nausea ( 23.3 ; 3.4 % ) , vomiting ( 15.0 % ; 0 ) and decreased appetite ( 15.0 ; 6.8 % ) .
CONCLUSIONS	Varenicline did not improve cognition , behavior or global change in this population .
CONCLUSIONS	The most frequent varenicline-associated AEs were gastrointestinal ; psychiatric AEs were rare and similar between the groups .

###25200513
BACKGROUND	Socioeconomic disadvantage is associated with shorter adult stature .
BACKGROUND	Few studies have examined socioeconomic differences in stature from birth to childhood and the mechanisms involved , particularly in middle-income former Soviet settings .
METHODS	The sample included 12,463 Belarusian children ( 73 % of the original cohort ) born in 1996-1997 , with up to 14 stature measurements from birth to 7 years .
METHODS	Linear spline multi-level models with 3 knots at 3 , 12 and 34 months were used to analyse birth length and growth velocity during four age-periods by parental educational achievement ( up to secondary school , advanced secondary/partial university , completed university ) and occupation ( manual , non-manual ) .
RESULTS	Girls born to the most ( versus least ) educated mothers were 0.43 cm ( 95 % confidence interval ( CI ) : 0.28 , 0.58 ) longer at birth ; for boys , the corresponding difference was 0.30 cm ( 95 % CI : 0.15 , 0.46 ) .
RESULTS	Similarly , children of the most educated mothers grew faster from birth-3 months and 12-34 months ( p-values for trend 0.08 ) , such that , by age 7 years , girls with the most ( versus least ) educated mothers were 1.92 cm ( 95 % CI : 1.47 , 2.36 ) taller ; after controlling for urban/rural and East/West area of residence , this difference remained at 1.86 cm ( 95 % CI : 1.42 , 2.31 ) , but after additionally controlling for mid-parental height , attenuated to 1.10 cm ( 95 % CI : 0.69 , 1.52 ) .
RESULTS	Among boys , these differences were 1.95 cm ( 95 % CI : 1.53 , 2.37 ) , 1.89 cm ( 95 % CI : 1.47 , 2.31 ) and 1.16 cm ( 95 % CI : 0.77 , 1.55 ) , respectively .
RESULTS	Additionally controlling for breastfeeding , maternal smoking and older siblings did not substantively alter these findings .
RESULTS	There was no evidence that the association of maternal educational attainment with growth differed in girls compared to boys ( p for interaction = 0.45 ) .
RESULTS	Results were similar for those born to the most ( versus least ) educated fathers , or who had a parent with a non-manual ( versus manual ) occupation .
CONCLUSIONS	In Belarus , a middle-income former Soviet country , socioeconomic differences in offspring growth commence in the pre-natal period and generate up to approximately 2 cm difference in height at age 7 years .
CONCLUSIONS	These associations are partly explained by genetic or other factors influencing parental stature .
BACKGROUND	Current Controlled Trials : NCT01352247 assigned 9 Sept 2005 ; ClinicalTrials.gov .
BACKGROUND	Identifier : NCT01561612 received 20 Mar 2012 .

###24314842
OBJECTIVE	To determine whether severe intraoperative floppy iris syndrome ( IFIS ) is more or equally likely with tamsulosin or alfuzosin .
METHODS	Prospective , masked , multicenter , cross-sectional study .
METHODS	Consecutive patients taking systemic tamsulosin or alfuzosin and scheduled for routine cataract surgery ( case group ) and patients with no history of systemic 1-antagonists scheduled for routine cataract surgery ( control group ) .
METHODS	Phacoemulsification with intraocular lens implantation was performed and recorded on video .
METHODS	Intracameral phenylephrine or epinephrine , either by direct injection or placement in the irrigation bottle , was not permitted .
METHODS	Every surgical video subsequently was reviewed remotely by 2 masked investigators who diagnosed the presence or absence of IFIS and graded the severity of IFIS as follows : none , mild ( billowing only ) , moderate ( billowing and either iris prolapse or 2 mm of pupil constriction ) , or severe ( billowing accompanied by iris prolapse and 2 mm of pupil constriction ) .
METHODS	Rate and severity of IFIS and surgical complication rate .
RESULTS	A total of 226 eyes ( 70 in the tamsulosin group , 43 in the alfuzosin group , and 113 in the control group ) were enrolled .
RESULTS	Severe IFIS was noted in 34.3 % ( 24/70 ) of the tamsulosin eyes and in 16.3 % ( 7/43 ) of the alfuzosin eyes compared with 4.4 % ( 5/113 ) of the control eyes .
RESULTS	The differences between each of the 3 groups were statistically significant .
RESULTS	In the absence of epinephrine in the irrigation bottle , 12.4 % of control eyes had moderate to severe IFIS .
RESULTS	There were no instances of posterior capsular rupture or significant surgical complications in either the case or control groups .
CONCLUSIONS	Moderate to severe IFIS can occur in low-risk eyes when epinephrine is omitted from the irrigation bottle .
CONCLUSIONS	Although both tamsulosin and alfuzosin significantly increase the risk of IFIS compared with patients without prior 1-antagonist intake , severe IFIS statistically was more likely with tamsulosin than with alfuzosin ( P = 0.036 ) .
CONCLUSIONS	Patients with symptomatic benign prostatic hyperplasia and cataracts requiring a uroselective 1-antagonist may consider trying alfuzosin first .

###24286115
BACKGROUND	Jet injectors allow needle-free insulin delivery .
BACKGROUND	The study objective was to compare the tolerability and device preference of subcutaneous insulin aspart delivery by jet injector ( InsuJet ; European Pharma Group , Schiphol-Rijk , The Netherlands ) with pen injection in an open-label , randomized , crossover pilot study .
METHODS	Ten participants with type 1 diabetes underwent two meal tolerance tests 1 week apart .
METHODS	Plasma glucose and serum insulin levels were sampled from 10 min preceding to 240 min after insulin aspart administration by InsuJet or FlexPen ( ) ( Novo Nordisk Pharmaceuticals Pty. Ltd. , Baulkham Hills , NSW , Australia ) .
METHODS	Insulin dose was calculated using participants ' insulin-to-carbohydrate ratios .
METHODS	Immediately after insulin administration , participants drank 500 mL of Ensure ( ) ( Abbott Australasia Pty. Ltd. , Botany , NSW , Australia ) ( providing 2,240 kJ of energy , 18.6 g of protein , 96 g of carbohydrate , and 3 g of fat ) .
RESULTS	In this small pilot study , the devices were similar in glucose excursion ( median [ quartile 1 , quartile 3 ] , InsuJet vs. FlexPen , 9.4 [ 4.8 , 12.8 ] vs. 8.1 [ 5.4 , 10.6 ] mmol/L ; P = 0.43 ) , in the area under the glucose concentration-time curve for 0-240 min corrected for baseline glucose level ( InsuJet vs. FlexPen , 1,230 [ 623 , 2,012 ] vs. 1,175 [ 91 , 1,774 ] mmol min/L ; P = 0.4 ) , and in insulin absorption over the 240-min period .
RESULTS	Devices were similar for participant preference and relative injection pain .
CONCLUSIONS	Subcutaneous jet injection of aspart insulin was well tolerated .

###26062622
BACKGROUND	Malnutrition in head and neck cancer ( HNC ) patients decreases survival , quality of life ( QOL ) and oncological outcomes .
BACKGROUND	The aim of the prospective three-year study was to compare QOL , clinical symptoms and variables ( complications , survival and mortality rates in HNC patients ) .
METHODS	A total of 726 patients aged 55 to 72 years with treatable HNC were included from January 2004 to December 2009 ; these patients were randomized to either group with PEG and enteral nutrition and nonPEG group with nutritional counselling according to nutritional care .
METHODS	We used EORTC questionnaires QOL C-30 and Head and neck module ( HN-35 ) for measuring of QOL .
METHODS	The following variables due to expectable influence on QOL ( demographic data , oncological data , nutritional screening , Clinical symptom score , Karnofsky performance status score , Charlson comorbidity index ) were included .
METHODS	Monitoring was done five times in three years .
RESULTS	In the first six months , we found decrease of weight and body mass index ( BMI ) .
RESULTS	After this critical time point and finish of oncological treatment , a marked difference in the development of patients treated with PEG .
RESULTS	Negative factors influencing patients survival , QOL , clinical status were males aged > 63 years , hypopharyngeal cancer ( stage III-IV ) , smoking , weight loss > 10 % , BMI < 21 and disallowance of PEG .
CONCLUSIONS	QOL is an essential factor for cancer patients .
CONCLUSIONS	Our study showed that nutritional intervention with early enteral nutrition may improve QOL and survival in HNC patients .
CONCLUSIONS	The PEG group better tolerated oncological treatment , had lower incidence of complications , shorter time to re-entry of permanent increase in weight , lower rate of rehospitalization and its shorter length .
CONCLUSIONS	We found QOL questionnaires to be very important for better understanding and communication and a key instrument for improving solution of patients difficulties during their therapy in multidisciplinary approach .

###25961184
OBJECTIVE	Oxidative stress and vascular impairment are believed to partly mediate age-related cognitive decline , a strong risk factor for development of dementia .
OBJECTIVE	Epidemiologic studies suggest that a Mediterranean diet , an antioxidant-rich cardioprotective dietary pattern , delays cognitive decline , but clinical trial evidence is lacking .
OBJECTIVE	To investigate whether a Mediterranean diet supplemented with antioxidant-rich foods influences cognitive function compared with a control diet .
METHODS	Parallel-group randomized clinical trial of 447 cognitively healthy volunteers from Barcelona , Spain ( 233 women [ 52.1 % ] ; mean age , 66.9 years ) , at high cardiovascular risk were enrolled into the Prevencin con Dieta Mediterrnea nutrition intervention trial from October 1 , 2003 , through December 31 , 2009 .
METHODS	All patients underwent neuropsychological assessment at inclusion and were offered retesting at the end of the study .
METHODS	Participants were randomly assigned to a Mediterranean diet supplemented with extravirgin olive oil ( 1 L/wk ) , a Mediterranean diet supplemented with mixed nuts ( 30 g/d ) , or a control diet ( advice to reduce dietary fat ) .
METHODS	Rates of cognitive change over time based on a neuropsychological test battery : Mini-Mental State Examination , Rey Auditory Verbal Learning Test ( RAVLT ) , Animals Semantic Fluency , Digit Span subtest from the Wechsler Adult Intelligence Scale , Verbal Paired Associates from the Wechsler Memory Scale , and the Color Trail Test .
METHODS	We used mean z scores of change in each test to construct 3 cognitive composites : memory , frontal ( attention and executive function ) , and global .
RESULTS	Follow-up cognitive tests were available in 334 participants after intervention ( median , 4.1 years ) .
RESULTS	In multivariate analyses adjusted for confounders , participants allocated to a Mediterranean dietplus olive oil scored better on the RAVLT ( P = .049 ) and Color Trail Test part 2 ( P = .04 ) compared with controls ; no between-group differences were observed for the other cognitive tests .
RESULTS	Similarly adjusted cognitive composites ( mean z scores with 95 % CIs ) for changes above baseline of the memory composite were 0.04 ( -0.09 to 0.18 ) for the Mediterranean diet plus olive oil , 0.09 ( -0.05 to 0.23 ; P = .04 vs controls ) for the Mediterranean diet plus nuts , and -0.17 ( -0.32 to -0.01 ) for the control diet .
RESULTS	Respective changes from baseline of the frontal cognition composite were 0.23 ( 0.03 to 0.43 ; P = .003 vs controls ) , 0.03 ( -0.25 to 0.31 ) , and -0.33 ( -0.57 to -0.09 ) .
RESULTS	Changes from baseline of the global cognition composite were 0.05 ( -0.11 to 0.21 ; P = .005 vs controls ) for the Mediterranean diet plus olive oil , -0.05 ( -0.27 to 0.18 ) for the Mediterranean diet plus nuts , and -0.38 ( -0.57 to -0.18 ) for the control diet .
RESULTS	All cognitive composites significantly ( P < .05 ) decreased from baseline in controls .
CONCLUSIONS	In an older population , a Mediterranean diet supplemented with olive oil or nuts is associated with improved cognitive function .
BACKGROUND	isrctn.org Identifier : ISRCTN35739639 .

###25303950
OBJECTIVE	To evaluate the effect of transcutaneous electrical acupuncture point stimulation ( TEAS ) on endometrial HOXA10 protein expression and three-dimensional ( 3D ) power Doppler ultrasound parameters as markers of endometrial receptivity in women undergoing frozen-thawed embryo transfer ( FET ) .
METHODS	A total of 68 women undergoing FET were randomised to receive TEAS or mock TEAS at acupuncture points CV3 , CV4 and SP6 and Zigong bilaterally .
METHODS	Both groups had six sessions per cycle for three menstrual cycles prior to the scheduled FET .
METHODS	Each session lasted 30min and was repeated every other day .
METHODS	3D power Doppler ultrasound parameters , HOXA10 protein expression and rates of embryo implantation , clinical pregnancy and live birth were compared .
RESULTS	There were no significant differences between the two groups in endometrial thickness or endometrial volume .
RESULTS	The ultrasonographic endometrial triple-line pattern was present more often in the TEAS group ( p = 0.002 ) .
RESULTS	The TEAS group had a greater endometrial and subendometrial vascularisation index ( VI ) than the mock TEAS group ( p = 0.001 and p < 0.001 , respectively ) on 3D ultrasound and increased endometrial HOXA10 expression ( p = 0.001 ) immediately prior to FET .
RESULTS	Subsequently , the rates of embryo implantation , clinical pregnancy and live birth rates were all higher in the TEAS group than in the mock TEAS group ( p = 0.024 , p = 0.038 and p = 0.033 , respectively ) .
CONCLUSIONS	In patients undergoing FET , TEAS may have beneficial effects on endometrial HOXA10 expression and ultrasound markers of endometrial receptivity .
CONCLUSIONS	These findings may explain the improvement in clinical outcome of FET associated with the use of TEAS .
BACKGROUND	ChiCTR-TRC-14004448 .

###25238873
BACKGROUND	Malignant pleural mesothelioma is an incurable cancer caused by exposure to asbestos .
BACKGROUND	The United Kingdom has the highest death rate from mesothelioma in the world and this figure is increasing .
BACKGROUND	Median survival is 8 to 12 months , and most patients have symptoms at diagnosis .
BACKGROUND	The fittest patients may be offered chemotherapy with palliative intent .
BACKGROUND	For patients not fit for systemic anticancer treatment , best supportive care remains the mainstay of management .
BACKGROUND	A study from the United States examining advanced lung cancer showed that early specialist palliative care input improved patient health related quality of life and depression symptoms 12 weeks after diagnosis .
BACKGROUND	While mesothelioma and advanced lung cancer share many symptoms and have a poor prognosis , oncology and palliative care services in the United Kingdom , and many other countries , vary considerably compared to the United States .
BACKGROUND	The aim of this trial is to assess whether regular early symptom control treatment provided by palliative care specialists can improve health related quality of life in patients newly diagnosed with mesothelioma .
METHODS	This multicentre study is an non-blinded , randomised controlled , parallel group trial .
METHODS	A total of 174 patients with a new diagnosis of malignant pleural mesothelioma will be minimised with a random element in a 1:1 ratio to receive either 4 weekly regular early specialist symptom control care , or standard care .
METHODS	The primary outcome is health related quality of life for patients at 12 weeks .
METHODS	Secondary outcomes include health related quality of life for patients at 24 weeks , carer health related quality of life at 12 and 24 weeks , patient and carer mood at 12 and 24 weeks , overall survival and analysis of healthcare utilisation and cost .
CONCLUSIONS	Current practice in the United Kingdom is to involve specialist palliative care towards the final weeks or months of a life-limiting illness .
CONCLUSIONS	This study aims to investigate whether early , regular specialist care input can result in significant health related quality of life gains for patients with mesothelioma and if this change in treatment model is cost-effective .
CONCLUSIONS	The results will be widely applicable to many institutions and patients both in the United Kingdom and internationally .
BACKGROUND	Current controlled trials ISRCTN18955704 .
BACKGROUND	Date ISRCTN assigned : 31 January 2014 .

###24684966
OBJECTIVE	To compare toric intraocular lens ( IOL ) implantation and astigmatic keratotomy ( AK ) in correction of astigmatism during phacoemulsification .
METHODS	Tertiary care hospital .
METHODS	Prospective randomized trial .
METHODS	Consecutive patients with visually significant cataract and moderate astigmatism ( 1.25 to 3.00 diopters [ D ] ) were randomized into 2 groups .
METHODS	Temporal clear corneal 2.75 mm phacoemulsification with toric IOL implantation was performed in the toric IOL group and with 30-degree coupled AK at the 7.0 mm optic zone in the keratotomy group .
METHODS	The uncorrected ( UDVA ) and corrected ( CDVA ) distance visual acuities , refraction , keratometry , topography , central corneal thickness , and endothelial cell density were evaluated preoperatively and 1 day , 1 week , and 1 and 3 months postoperatively .
RESULTS	The study enrolled 34 eyes ( 34 patients ) , 17 in each group .
RESULTS	There was no difference in UDVA or CDVA between the 2 groups at any follow-up visit .
RESULTS	The mean preoperative and postoperative refractive cylinder was 2.00 D 0.49 ( SD ) and 0.33 0.17 D , respectively , in the toric IOL group and 1.95 0.47 D and 0.57 0.41 D , respectively , in the keratotomy group ( P = .10 ) .
RESULTS	The mean residual astigmatism at 3 months was 0.44 1.89 @ 160 in the toric IOL group and 0.77 1.92 @ 174 in the keratotomy group ( P = .61 ) .
RESULTS	All eyes in the toric IOL group and 14 eyes ( 84 % ) in the keratotomy group achieved a residual refractive cylinder of 1.00 D or less ( P = .17 ) .
CONCLUSIONS	Toric IOL implantation was comparable to AK in eyes with moderate astigmatism having phacoemulsification .

###26130119
BACKGROUND	Impairment in left ventricular systolic function has been described in heart failure ( HF ) with preserved ejection fraction ( HFpEF ) , but its prognostic relevance is not known .
BACKGROUND	We determined whether left ventricular longitudinal strain ( LS ) is predictive of cardiovascular outcomes in HFpEF beyond clinical and conventional echocardiographic measures .
RESULTS	LS was assessed by 2-dimensional speckle-tracking echocardiography at baseline in 447 patients with HFpEF enrolled in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist ( TOPCAT ) trial .
RESULTS	At a median follow-up of 2.6 years ( interquartile range , 1.5-3 .9 years ) , 115 patients experienced the primary composite outcome of cardiovascular death , HF hospitalization , or aborted cardiac arrest .
RESULTS	Impaired LS , defined as an absolute LS < 15.8 % , was present in 52 % of patients and was predictive of the composite outcome ( adjusted hazard ratio , 2.14 ; 95 % confidence interval , 1.26-3 .66 ; P = 0.005 ) , cardiovascular death alone ( adjusted hazard ratio , 3.20 ; 95 % confidence interval , 1.44-7 .12 ; P = 0.004 ) , and HF hospitalization alone ( adjusted hazard ratio , 2.23 ; 95 % confidence interval , 1.16-4 .28 ; P = 0.016 ) after adjustment for clinical and conventional echocardiographic variables .
RESULTS	LS was the strongest echocardiographic predictor of the composite outcome .
RESULTS	Exploratory analysis in a subset of 131 patients with follow-up LS assessed after 12 to 18 months demonstrated a trend toward improvement in LS associated with spironolactone in patients enrolled in the Americas but not in Russia or Georgia .
CONCLUSIONS	Impaired left ventricular systolic function is a powerful predictor of HF hospitalization , cardiovascular death , or aborted cardiac arrest in HFpEF independent of clinical predictors .
CONCLUSIONS	Impaired LS represents a novel imaging biomarker to identify patients with HFpEF at particularly high risk for cardiovascular morbidity and mortality .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00094302 .

###24500238
OBJECTIVE	We evaluated the effect of different dose hydration protocols , with normal saline or bicarbonate , on the incidence of contrast-induced acute kidney injury ( CI-AKI ) in patients with ST-elevation myocardial infarction ( STEMI ) treated with primary percutaneous coronary intervention ( PPCI ) .
METHODS	We considered 592 STEMI patients treated with PPCI in 5 Italian centers .
METHODS	Patients were randomized to receive standard or high-dose infusions of normal saline or sodium bicarbonate started immediately before contrast medium administration and continued for the following 12h .
RESULTS	The cumulative incidence of CI-AKI was 18.1 % without any difference among treatment groups .
RESULTS	Shock , age , ejection fraction 35 % or less , and basal serum creatinine were significantly associated with an increased risk of CI-AKI .
RESULTS	Follow-up at 12 months was complete in 573 patients .
RESULTS	Overall , 25 out of 573 patients died ( 4.3 % ) .
RESULTS	We observed higher short-term mortality rates in patients receiving high-volume hydration .
RESULTS	Otherwise , only age , shock and CI-AKI were significantly associated with 1-year mortality .
CONCLUSIONS	In patients with STEMI undergoing PPCI , high-volume hydration with normal saline or sodium bicarbonate administrated at the time of contrast media administration was not associated with any significant advantage in terms of CI-AKI prevention .

###24743802
OBJECTIVE	The authors examined the effectiveness of virtual reality exposure augmented with D-cycloserine or alprazolam , compared with placebo , in reducing posttraumatic stress disorder ( PTSD ) due to military trauma .
METHODS	After an introductory session , five sessions of virtual reality exposure were augmented with D-cycloserine ( 50 mg ) or alprazolam ( 0.25 mg ) in a double-blind , placebo-controlled randomized clinical trial for 156 Iraq and Afghanistan war veterans with PTSD .
RESULTS	PTSD symptoms significantly improved from pre - to posttreatment across all conditions and were maintained at 3 , 6 , and 12 months .
RESULTS	There were no overall differences in symptoms between D-cycloserine and placebo at any time .
RESULTS	Alprazolam and placebo differed significantly on the Clinician-Administered PTSD Scale score at posttreatment and PTSD diagnosis at 3 months posttreatment ; the alprazolam group showed a higher rate of PTSD ( 82.8 % ) than the placebo group ( 47.8 % ) .
RESULTS	Between-session extinction learning was a treatment-specific enhancer of outcome for the D-cycloserine group only .
RESULTS	At posttreatment , the D-cycloserine group had the lowest cortisol reactivity and smallest startle response during virtual reality scenes .
CONCLUSIONS	A six-session virtual reality treatment was associated with reduction in PTSD diagnoses and symptoms in Iraq and Afghanistan veterans , although there was no control condition for the virtual reality exposure .
CONCLUSIONS	There was no advantage of D-cycloserine for PTSD symptoms in primary analyses .
CONCLUSIONS	In secondary analyses , alprazolam impaired recovery and D-cycloserine enhanced virtual reality outcome in patients who demonstrated within-session learning .
CONCLUSIONS	D-cycloserine augmentation reduced cortisol and startle reactivity more than did alprazolam or placebo , findings that are consistent with those in the animal literature .

###24268861
OBJECTIVE	To test whether long-term multivitamin supplementation affects the incidence of cataract or age-related macular degeneration ( AMD ) in a large cohort of men .
METHODS	Randomized , double-blind , placebo-controlled trial .
METHODS	A total of 14,641 US male physicians aged 50 years .
METHODS	Daily multivitamin or placebo .
METHODS	Incident cataract and visually significant AMD responsible for a reduction in best-corrected visual acuity to 20/30 or worse based on self-reports confirmed by medical record review .
RESULTS	During an average of 11.2 years of treatment and follow-up , a total of 1817 cases of cataract and 281 cases of visually significant AMD were confirmed .
RESULTS	There were 872 cataracts in the multivitamin group and 945 cataracts in the placebo group ( hazard ratio [ HR ] , 0.91 ; 95 % confidence interval [ CI ] , 0.83-0 .99 ; P = 0.04 ) .
RESULTS	For visually significant AMD , there were 152 cases in the multivitamin group and 129 cases in the placebo group ( HR , 1.19 ; 95 % CI , 0.94-1 .50 ; P = 0.15 ) .
CONCLUSIONS	These randomized trial data from a large cohort of middle-aged and older US male physicians indicate that long-term daily multivitamin use modestly and significantly decreased the risk of cataract but had no significant effect on visually significant AMD .

###24639438
BACKGROUND	Despite numerous population-based randomized intervention trials , the impact of such interventions on socioeconomic inequalities has rarely been examined .
BACKGROUND	We used data from a large cluster-randomized trial to assess the impact of a breastfeeding promotion intervention on socioeconomic inequalities in breastfeeding ( exclusivity and duration ) and in child cognitive ability at early school age .
METHODS	The Promotion of Breastfeeding Intervention Trial ( PROBIT ) randomized 31 Belarusian maternity hospitals and their affiliated polyclinics either to receive a breastfeeding promotion intervention modelled on the WHO/UNICEF Baby-Friendly Hospital Initiative or to continue the standard practices in effect at the time of randomization .
METHODS	We estimated and compared inequalities in discontinuation of exclusive breastfeeding before 3 months and of any breastfeeding before 12 months and in child verbal IQ at age 6.5 years , across maternal education strata between the two intervention arms .
RESULTS	Socioeconomic inequalities in discontinuing exclusive breastfeeding before 3 months were negligible in the control group .
RESULTS	However , graded inequalities by maternal education emerged in the intervention group { relative risk [ RR ] = 1.12 [ 95 % confidence interval ( CI ) : 1.04 , 1.20 ] for partial university and RR = 1.20 [ 95 % CI : 1.11 , 1.31 ] for secondary education or less vs complete university ; risk difference [ RD ] = 0.06 [ 95 % CI : 0.03 , 0.09 ] and 0.10 [ 95 % CI : 0.06 , 0.14 ] , respectively } .
RESULTS	For discontinuing any breastfeeding before 12 months , small socioeconomic gradients in the control group were widened in the intervention group ( RR = 1.04 and 1.16 , respectively , for mothers with secondary education or less ) .
RESULTS	Despite these differential effects on breastfeeding , however , we observed a small , nonsignificant reduction in socioeconomic inequalities in child verbal IQ at age 6.5 years .
CONCLUSIONS	A population-based intervention to promote breastfeeding slightly widened socioeconomic inequalities in breastfeeding but not those in child cognitive ability .

###24728035
BACKGROUND	Some trial have demonstrated a benefit of adjuvant fluoropirimidine with or without platinum compounds compared with surgery alone .
BACKGROUND	ITACA-S study was designed to evaluate whether a sequential treatment of FOLFIRI [ irinotecan plus 5-fluorouracil/folinic acid ( 5-FU/LV ) ] followed by docetaxel plus cisplatin improves disease-free survival in comparison with 5-FU/LV in patients with radically resected gastric cancer .
METHODS	Patients with resectable adenocarcinoma of the stomach or gastroesophageal junction were randomly assigned to either FOLFIRI ( irinotecan 180 mg/m ( 2 ) day 1 , LV 100 mg/m ( 2 ) as 2 h infusion and 5-FU 400 mg/m ( 2 ) as bolus , days 1 and 2 followed by 600 mg/m ( 2 ) / day as 22 h continuous infusion , q14 for four cycles ) followed by docetaxel 75 mg/m ( 2 ) day 1 , cisplatin 75 mg/m ( 2 ) day 1 , q21 for three cycles ( sequential arm ) or De Gramont regimen ( 5-FU/LV arm ) .
RESULTS	From February 2005 to August 2009 , 1106 patients were enrolled , and 1100 included in the analysis : 562 in the sequential arm and 538 in the 5-FU/LV arm .
RESULTS	With a median follow-up of 57.4 months , 581 patients recurred or died ( 297 sequential arm and 284 5-FU/LV arm ) , and 483 died ( 243 and 240 , respectively ) .
RESULTS	No statistically significant difference was detected for both disease-free [ hazard ratio ( HR ) 1.00 ; 95 % confidence interval ( CI ) : 0.85-1 .17 ; P = 0.974 ] and overall survival ( OS ) ( HR 0.98 ; 95 % CI : 0.82-1 .18 ; P = 0.865 ) .
RESULTS	Five-year disease-free and OS rates were 44.6 % and 44.6 % , 51.0 % and 50.6 % in the sequential and 5-FU/LV arm , respectively .
CONCLUSIONS	A more intensive regimen failed to show any benefit in disease-free and OS versus monotherapy .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01640782 .

###24374073
BACKGROUND	Brain metastases are often accompanied by edema .
BACKGROUND	Endostatin therapy can prevent tumor tissue edema .
BACKGROUND	Therefore , we investigated the therapeutic effects of endostatin combined with radiotherapy in the treatment of brain metastases of non-small cell lung cancer ( NSCLC ) and assessed the relations between the effect and vascular endothelial growth factor receptor 2 ( VEGFR2 ) expression .
METHODS	Eighty patients with brain metastases of NSCLC were randomly divided into a combination therapy group and a radiotherapy-alone group , each group with 40 patients .
METHODS	The short-term effective rate , overall survival time , cerebral edema index , and adverse reactions were observed , and the expressions of VEGFR2 protein and KDR gene in primary lesions were detected via immunohistochemical methods and fluorescence in-situ hybridization ( FISH ) in all patients .
RESULTS	Compared with the radiotherapy-alone group , brain edema was significantly relieved ( P = .003 ) and there were no marked adverse reactions in the combination therapy group .
RESULTS	Regarding the short-term effective rate , there was no statistical significance in the total population ( n = 80 , 90 % vs. 75 % , P = .07 ) , but there was statistical significance in cases of positive VEGFR2 ( 93 % vs. 67.7 % , P = .012 ) or positive KDR gene ( 94.4 % vs. 47.3 % , P = .002 ) in both groups .
RESULTS	For overall survival time , there was no statistical significance in total population ( n = 80 , P = .35 ) , positive VEGFR2 patients ( P = .109 ) , and positive KDR gene patients ( P = .147 ) .
CONCLUSIONS	Compared with radiotherapy alone , endostatin combined with radiotherapy can relieve brain edema in patients with brain metastases of NSCLC and can obtain a better short-term effective rate in patients with positive VEGFR2 or positive KDR gene , but endostatin therapy does not significantly improve overall survival time .

###25926415
BACKGROUND	It has been demonstrated that protein ingestion before sleep increases muscle protein synthesis rates during overnight recovery from an exercise bout .
BACKGROUND	However , it remains to be established whether dietary protein ingestion before sleep can effectively augment the muscle adaptive response to resistance-type exercise training .
OBJECTIVE	Here we assessed the impact of dietary protein supplementation before sleep on muscle mass and strength gains during resistance-type exercise training .
METHODS	Forty-four young men ( 22 1 y ) were randomly assigned to a progressive , 12-wk resistance exercise training program .
METHODS	One group consumed a protein supplement containing 27.5 g of protein , 15 g of carbohydrate , and 0.1 g of fat every night before sleep .
METHODS	The other group received a noncaloric placebo .
METHODS	Muscle hypertrophy was assessed on a whole-body ( dual-energy X-ray absorptiometry ) , limb ( computed tomography scan ) , and muscle fiber ( muscle biopsy specimen ) level before and after exercise training .
METHODS	Strength was assessed regularly by 1-repetition maximum strength testing .
RESULTS	Muscle strength increased after resistance exercise training to a significantly greater extent in the protein-supplemented ( PRO ) group than in the placebo-supplemented ( PLA ) group ( +164 11 kg and +130 9 kg , respectively ; P < 0.001 ) .
RESULTS	In addition , quadriceps muscle cross-sectional area increased in both groups over time ( P < 0.001 ) , with a greater increase in the PRO group than in the PLA group ( +8.4 1.1 cm ( 2 ) vs. +4.8 0.8 cm ( 2 ) , respectively ; P < 0.05 ) .
RESULTS	Both type I and type II muscle fiber size increased after exercise training ( P < 0.001 ) , with a greater increase in type II muscle fiber size in the PRO group ( +2319 368 m ( 2 ) ) than in the PLA group ( +1017 353 m ( 2 ) ; P < 0.05 ) .
CONCLUSIONS	Protein ingestion before sleep represents an effective dietary strategy to augment muscle mass and strength gains during resistance exercise training in young men .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT02222415 .

###24472402
BACKGROUND	The transient receptor potential vanilloid 1 ( TRPV1 ) - expressing sensory C-fibers may play a role in the development of nasal hyper-responsiveness and symptoms of non-allergic rhinitis ( NAR ) .
OBJECTIVE	To evaluate the effects of a TRPV1-antagonist , SB-705498 , on cold dry air ( CDA ) - induced symptoms in patients with NAR .
METHODS	This randomized , double-blind , placebo-controlled , crossover study evaluated 14 days of once daily , topical intranasal SB-705498 12 mg in 40 patients with NAR using a CDA challenge experimental model in an environmental exposure chamber ( EEC , Cetero Research , Mississauga , Ontario ) .
METHODS	The primary endpoint was total symptom score ( TSS ) , expressed as weighted mean over 60 minutes ( WM0-60 ) or maximum TSS at 1 hour and 24 hours postdosing .
RESULTS	Treatment with SB-705498 , relative to placebo , did not improve WM0-60 or maximum TSS at 1 hour and 24 hours post-dosing on days 1 or 14 .
RESULTS	Mean ( 95 % CI ) treatment differences ( SB-705498 - placebo ) on day 14 were , for WM0-60 at 1 hour : -0.12 ( -0.60 , 0.36 ) ; for maximum TSS at 1 hour : -0.03 ( -0.58 , 0.51 ) .
RESULTS	SB-705498 had no impact on any other efficacy parameters .
RESULTS	SB-705498 was well tolerated and pharmacokinetics analysis supported the dosing regimen .
CONCLUSIONS	SB-705498 12 mg for 14 days did not alleviate the CDA-induced symptoms of NAR .
CONCLUSIONS	Despite engagement of the TRPV1 receptor , there was no translation to clinical efficacy , suggesting redundancy in symptom pathways .

###25055938
OBJECTIVE	A prospective randomized clinical trial was conducted to evaluate the efficacy of tamoxifen plus doxorubicin and cyclophosphamide compared to tamoxifen plus tegafur-uracil as an adjuvant therapy to treat node-positive premenopausal breast cancer ( PreMBC ) .
METHODS	Eligibility criteria included pathologically node-positive ( n = 1-9 ) preMBC with curative resection , in stages I-IIIA .
METHODS	Patients were randomized to receive either tamoxifen 20 mg/day plus tegafur-uracil 400 mg/day ( TU ) for 2 years or six courses of a 28-day cycle of doxorubicin 40 mg/m ( 2 ) plus cyclophosphamide 500 mg/m ( 2 ) on day 1 along with tamoxifen ( ACT ) given for 2 years as adjuvant therapy .
METHODS	Primary endpoint was overall survival ( OS ) , and secondary endpoint was recurrence-free survival ( RFS ) .
RESULTS	In total , 169 patients were recruited ( TU arm 87 , ACT arm 82 ) between October 1994 and September 1999 .
RESULTS	The HR for OS was 0.76 ( 95 % CI 0.35 , 1.66 , log-rank p = 0.49 ) and that for RFS was 0.77 ( 95 % CI 0.44 , 1.36 , log-rank p = 0.37 ) , with ACT resulting in a better HR .
RESULTS	The 5-year OS was 79.7 % for patients in the TU arm and 83 % for those in the ACT arm .
RESULTS	The 5-year RFS was 66.1 % for patients in the TU arm and 70.6 % for those in the ACT arm .
RESULTS	A higher proportion of patients in the ACT arm experienced grade 3 leucopenia ( 0 % in the TU arm , 4 % in the ACT arm ) .
CONCLUSIONS	There were no significant differences in the efficacy of TU and ACT as adjuvant therapy .

###24655212
BACKGROUND	Obesity runs in families , and family-based behavioral treatment ( FBT ) is associated with weight loss in overweight/obese children and their overweight/obese parents .
BACKGROUND	This study was designed to estimate the costs and cost-effectiveness of FBT compared to separate group treatments of the overweight/obese parent and child ( PC ) .
METHODS	Fifty overweight/obese 8 - to 12-year-old children with overweight/obese parents were randomly assigned to 12 months of either FBT or PC treatment program .
METHODS	Assessment of societal costs ( payer plus opportunity costs ) were completed based on two assumptions : ( 1 ) programs for parent and child were available on separate days ( PC-1 ) or ( 2 ) interventions for parent and child were available in the same location at sequential times on the same day ( PC-2 ) .
METHODS	Cost-effectiveness was calculated based on societal cost per unit of change using percent overBMI for children and weight for parents .
RESULTS	The average societal cost per family was $ 1,448 for FBT and $ 2,260 for PC-1 ( p < 0.001 ) and $ 2,124 for PC-2 ( p < 0.001 ) .
RESULTS	Child cost-effectiveness for FBT was $ 209.17 / percent overBMI , compared to $ 1,036.50 / percent overBMI for PC-1 and $ 973.98 / percent overBMI for PC-2 .
RESULTS	Parent cost-effectiveness was $ 132.97 / pound ( lb ) for FBT and $ 373.53 / lb ( PC-1 ) or $ 351.00 / lb ( PC-2 ) .
CONCLUSIONS	For families with overweight/obese children and parents , FBT presents a lower cost per unit of weight loss for parents and children than treating the parent and child separately .
CONCLUSIONS	Given the high rates of pediatric and adult obesity , FBT may provide a unique cost-effective platform for obesity intervention that alters weight in overweight/obese parents and their overweight/obese children .

###26218826
BACKGROUND	Pseudogynecomastia refers to benign male breast enlargement due to excess subareolar fat .
BACKGROUND	Standard treatment is surgical excision under general anesthesia , liposuction , or a combination of both .
OBJECTIVE	The safety and efficacy of cryolipolysis was investigated for nonsurgical treatment of pseudogynecomastia .
METHODS	Enrollment consisted of 21 males with pseudogynecomastia .
METHODS	Subjects received a first treatment consisting of a 60-minute cryolipolysis cycle , followed by a two-minute massage , and a second 60-minute cycle with 50 % treatment area overlap .
METHODS	At 60 days of follow-up , subjects received a second 60-minute treatment .
METHODS	Safety was evaluated by monitoring side effects and adverse events .
METHODS	Efficacy was assessed by ultrasound , clinical photographs , and subject surveys .
RESULTS	Surveys revealed that 95 % of subjects reported improved visual appearance and 89 % reported reduced embarrassment associated with pseudogynecomastia .
RESULTS	Ultrasound showed mean fat layer reduction of 1.6 1.2 mm .
RESULTS	Blinded reviewers correctly identified 82 % of baseline photographs .
RESULTS	Side effects included mild discomfort during treatment and transient paresthesia and tenderness .
RESULTS	One case of paradoxical hyperplasia ( PH ) occurred but likelihood of PH in the male breast is not believed to be greater than in any other treatment area .
CONCLUSIONS	This study demonstrated feasibility of cryolipolysis for safe , effective , and well-tolerated nonsurgical treatment of pseudogynecomastia .

###25077452
BACKGROUND	Although fatigue , sleep disturbance , depression , and anxiety are associated with pain in breast cancer patients , it is unknown whether acupuncture can decrease these comorbid symptoms in cancer patients with pain .
BACKGROUND	The objective of this study was to evaluate the effect of electroacupuncture ( EA ) on fatigue , sleep , and psychological distress in breast cancer survivors who experience joint pain related to aromatase inhibitors ( AIs ) .
METHODS	The authors performed a randomized controlled trial of an 8-week course of EA compared with a waitlist control ( WLC ) group and a sham acupuncture ( SA ) group in postmenopausal women with breast cancer who self-reported joint pain attributable to AIs .
METHODS	Fatigue , sleep disturbance , anxiety , and depression were measured using the Brief Fatigue Inventory ( BFI ) , the Pittsburgh Sleep Quality Index ( PSQI ) , and the Hospital Anxiety and Depression Scale ( HADS ) .
METHODS	The effects of EA and SA versus WLC on these outcomes were evaluated using mixed-effects models .
RESULTS	Of the 67 randomly assigned patients , baseline pain interference was associated with fatigue ( Pearson correlation coefficient [ r ] = 0.75 ; P < .001 ) , sleep disturbance ( r = 0.38 ; P = .0026 ) , and depression ( r = 0.58 ; P < .001 ) .
RESULTS	Compared with the WLC condition , EA produced significant improvements in fatigue ( P = .0095 ) , anxiety ( P = .044 ) , and depression ( P = .015 ) and a nonsignificant improvement in sleep disturbance ( P = .058 ) during the 12-week intervention and follow-up period .
RESULTS	In contrast , SA did not produce significant reductions in fatigue or anxiety symptoms but did produce a significant improvement in depression compared with the WLC condition ( P = .0088 ) .
CONCLUSIONS	Compared with usual care , EA produced significant improvements in fatigue , anxiety , and depression ; whereas SA improved only depression in women experiencing AI-related arthralgia .

###25452050
BACKGROUND	The present study examined self-affirmation theory , cigarette smoking , and health-related images depicting adverse effects of smoking .
BACKGROUND	Previous research examining self-affirmation and negative health-related images has shown that individuals who engage in a self-affirmation activity are more receptive to messages when compared to those who do not affirm .
BACKGROUND	We were interested in examining the extent to which self-affirmation would reduce defensive responding to negative health images related to cigarette smoking .
METHODS	Participants included 203 daily smokers who were undergraduate students at a large southern university .
METHODS	Participants completed a battery of questionnaires and were then randomly assigned to one of four conditions ( non-smoking image control , smoking image control , low affirmation , and high affirmation ) .
METHODS	Analyses evaluated the effectiveness of affirmation condition as it related to defensive responding .
RESULTS	Results indicated that both affirmation conditions were effective in reducing defensive responding for those at greatest risk ( heavier smokers ) and those more resistant to health benefits associated with quitting .
CONCLUSIONS	Findings are discussed in terms of potential public health implications as well as the role defensive responding plays in the evaluation and processing of negative health messages .

###24612260
OBJECTIVE	Ketamine is one of the most commonly used sedatives for facilitating painful procedures for paediatric patients in the emergency department ( ED ) .
OBJECTIVE	However , the use of ketamine is associated with a common , though not serious , adverse event usually called ketamine-associated vomiting ( KAV ) .
OBJECTIVE	The purpose of this study is to evaluate the anti-emetic effect of adjunctive ondansetron in paediatric patients receiving ketamine sedation in the ED .
METHODS	We conducted a prospective , randomised , open , controlled study in children from 1 to 18 years of age who had undergone intramuscular ketamine sedation in the ED .
METHODS	The patients were randomised into two groups : a ketamine-only group and a ketamine/ondansetron group .
METHODS	The patients in the first group received ketamine alone , while those in the second group received ketamine with oral ondansetron .
METHODS	The incidence of KAV was estimated in the ED and after discharge , and the time to resumption of a normal diet was measured after sedation .
RESULTS	A total of 237 patients were analysed .
RESULTS	The incidence of KAV was 29.7 % in the ketamine-only group and 25.2 % in the ketamine/ondansetron group ( P = 0.47 ) .
RESULTS	After administration of ketamine , the mean time to resumption of a normal diet was 8 h 54 min in the ketamine-only group and 8 h 39 min in the ketamine/ondansetron group ( P = 0.67 ) .
CONCLUSIONS	A relatively high rate of KAV ( 29.7 % ) was observed , and the time to resumption of a normal diet after ketamine sedation was rather long .
CONCLUSIONS	It turned out that , however , the adjunctive administration of ondansetron did not effectively reduce the incidence of KAV .

###24902475
OBJECTIVE	Neurologic diseases such as stroke are risk factors for new-onset epilepsy in older adults .
OBJECTIVE	Recent evidence suggests that psychiatric disorders independently predict epilepsy in older male veterans .
OBJECTIVE	Our aim was to examine the relationship between these disorders in a population-based study of older adults that also included women and minorities .
METHODS	We used a national 5 % random sample of 2005 Medicare beneficiaries including all 50 US states and Washington , DC .
METHODS	Beneficiaries were 65 years of age or older , with continuous Medicare Part A and Part B coverage and not in managed care plans .
METHODS	Epilepsy cases were identified from claims for physician visits , hospitalizations , and outpatient procedures .
METHODS	We used logistic regressions for the overall sample and stratified by gender to determine whether risk of new-onset epilepsy was associated with prior history of psychiatric ( i.e. , depression , psychosis , bipolar disorder , schizophrenia , posttraumatic stress disorder ( PTSD ) , adjustment disorder , and substance abuse/dependence ) and neurologic conditions ( i.e. , cerebrovascular disease , dementia , traumatic brain injury , brain tumor , metastatic cancer ) .
RESULTS	Preexisting psychiatric disorders were significantly associated with new-onset epilepsy in the study population as were the neurologic conditions evaluated .
RESULTS	Five of the seven psychiatric disorders examined were independently associated with new-onset epilepsy ; substance abuse , psychosis , bipolar disorder , schizophrenia , and depression .
RESULTS	Gender interaction effects were found for substance abuse/dependence and brain tumors .
CONCLUSIONS	Both neurologic and psychiatric factors significantly predicted new-onset epilepsy in a population-based sample of male and female older adults .
CONCLUSIONS	These results support earlier findings and extend the understanding of risk models for new-onset epilepsy in broader older adult populations .

###24917060
OBJECTIVE	Whereas it is established that endothelin-1 elicits sustained deleterious effects on the cardiovascular system during cardiopulmonary bypass ( CPB ) , presently it remains unknown whether the inhaled administration of the dual ETA and ETB antagonist tezosentan prevents the development of pulmonary endothelial dysfunction .
METHODS	A prospective , randomized laboratory investigation .
METHODS	University research laboratory .
METHODS	Landrace swine .
METHODS	Three groups of animals underwent a 90-minute period of full bypass followed by a 60-minute period of reperfusion .
METHODS	Among treated groups , one received tezosentan through inhalation prior to CPB , whereas the other one received it intravenously at weaning from CPB ; the third group remained untreated .
METHODS	Pulmonary vascular reactivity studies , realized on a total of 285 rings , were performed in all groups , including 1 sham .
RESULTS	The contractility of pulmonary arteries to prostaglandin F2 and to the thromboxane A2 mimetic U46619 was preserved in animals submitted to CPB .
RESULTS	By contrast , there were significant increases both in the maximal contraction to endothelin-1 and in the plasma levels of the peptide 60minutes after reperfusion .
RESULTS	Tezosentan administered by inhalation or intravenously did not prevent the development of pulmonary CPB-associated endothelial dysfunction .
RESULTS	However , while hemodynamic disturbances were improved with both routes , the inhaled administration had a beneficial effect on oxygen parameters over intravenous administration .
CONCLUSIONS	Despite the blockade of the endothelin-1 pathway with tezosentan , the development of the pulmonary endothelial dysfunction associated with CPB still occurred .
CONCLUSIONS	However , only the inhalation route had a significant impact on gas exchange during CPB .

###25431866
BACKGROUND	Recently , the UK CCLG and COG reported that an intrachromosomal amplification of chromosome 21 ( iAMP21 ) in acute lymphoblastic leukemia ( ALL ) loses its adverse prognostic impact with intensified therapy .
METHODS	We evaluated the prognosis of iAMP21 among patients from the ALL-BFM ( Berlin-Frankfurt-Mnster ) 2000 trial with 46 of 2637 ( 2 % ) patients iAMP21 + .
RESULTS	8-year event-free-survival ( EFS , 64 8 % vs. 81 1 % , p = 0.0026 ) and cumulative incidence of relapse ( CIR , 29 8 % vs. 14 1 % , p = 0.008 ) of the iAMP21 cases were significantly worse compared with non-iAMP21 patients .
RESULTS	Within the MRD low-risk group , iAMP21 cases ( n = 14 ) had an inferior 8-year EFS ( 76 12 % vs. 92 1 % , p = 0.0081 ) , but no increased CIR ( 10 10 % vs. 6 1 % , p = 0.624 ) .
RESULTS	Within the MRD intermediate-risk group , iAMP21 cases ( n = 27 ) had a worse 8-year EFS ( 56 11 % vs. 78 2 % , p = 0.0077 ) and CIR ( 44 11 % vs. 20 2 % , p = 0.003 ) with 6/10 relapses occurring after 2 years .
CONCLUSIONS	Conclusively , we believe that there is no necessity for enrolling all iAMP21 patients into the high-risk arm of ongoing ALL-BFM trials because MRD low-risk patients have a moderate relapse risk under current therapy .
CONCLUSIONS	Whether the increased relapse risk in MRD intermediate-risk patients can be avoided by late treatment intensification remains to be answered by the AIEOP-BFM ALL 2009 trial randomly using protracted pegylated L-asparaginase during delayed intensification and early maintenance .

###24628498
OBJECTIVE	We investigated which factors can best predict relapse in older patients with major depressive disorder ( MDD ) who have achieved remission with escitalopram .
METHODS	A total of 405 patients who were 65 years or older with a primary diagnosis of MDD received 12 week , open-label escitalopram 10 or 20mg/day .
METHODS	Patients in remission ( MADRS 12 ) at Week 12 were randomized to 24 weeks of double-blind treatment with either placebo or escitalopram ( fixed dose from Week 6 ) .
RESULTS	After randomization of 312 patients in remission , patients whose dose had been increased to 20mg escitalopram after 2 weeks of open-label treatment had a high escitalopram relapse rate ( 16.7 % ) and a placebo relapse rate of 32.5 % with a hazard ratio ( HR ) of 2.2 , whereas patients titrated to 20mg escitalopram at Weeks 4 or 6 had a high placebo relapse rate ( 41.2 % ) and an escitalopram relapse rate of 5.7 % with a HR = 8.9 .
RESULTS	A high placebo relapse rate was also observed for patients with a baseline MADRS below median , while low escitalopram relapse rates were characteristic of patients who had achieved remission by Week 6 or 8 ( HR = 8.9 ) , had a current depressive episode length below median , baseline MADRS below median ( HR = 11.8 ) , or received 10mg for 12 weeks ( HR = 6.3 ) .
RESULTS	A key limitation of the study was that some analyses were post-hoc and that none of the comparisons between complementary subgroups had nominal p-values < 0.05 .
CONCLUSIONS	In this post-hoc analysis of elderly patients with MDD , several factors , including female gender , early remission , low baseline MADRS score , major depressive episode ( MDE ) duration , and escitalopram dosage , significantly affected the relapse rate after randomization to escitalopram or placebo .

###25174846
OBJECTIVE	The study aims to compare the stress shielding effects of implantable anatomical and traditional prostheses after in vitro total hip joint replacement simulation .
OBJECTIVE	The study serves as a biomechanical basis for novel artificial prostheses and for clinical hip joint replacements .
METHODS	Sixteen femoral specimens from adult male corpses were randomly divided into two groups : the traditional prosthesis group implanted into femur specimens using simulated total hip joint replacement ( n = 8 ) and the femoral neck-preserved anatomical prosthesis implantation group that used a collum femoris preserving stem/trabeculae oriented pattern ( CFP/TOP ) acetabular cup ( n = 8 ) .
METHODS	The strain values in the two groups before and after prosthesis implantation were measured at different test points using electric resistance strain gauges .
METHODS	The stress shielding rate was calculated according to the related formula .
RESULTS	The results showed that the rates of proximal femoral stress shielding were significantly higher at test points 1-10 in the traditional femoral prosthesis transplantation group than in the anatomical prosthesis group ( p < 0.05 ) .
CONCLUSIONS	There were different effects of stress shielding between the anatomical and traditional prostheses .
CONCLUSIONS	Retained femoral anatomical implants should reduce stress shielding and increase the stability of anatomical prosthesis implants .

###24325574
OBJECTIVE	The self-control strength model suggests that exertion of self-control leads to poorer subsequent self-control performance .
OBJECTIVE	Failure of self-control has been suggested as an important underlying mechanism of excessive drinking .
OBJECTIVE	This study tested the effects of self-control failure on ad libitum drinking , and the potential moderating role of glucose and self-awareness on this relationship .
METHODS	The current research examined in two experiments whether the effects of self-control failure were different for males and females , and whether glucose ( experiment 1 ) and self-awareness ( experiment 2 ) would counteract the effects of self-control failure .
METHODS	A between-participants design with four conditions was employed in each experiment .
METHODS	A semi-naturalistic drinking setting in the form of a laboratory bar .
METHODS	Undergraduate students recruited at Radboud University Nijmegen , the Netherlands ( experiment 1 : n = 106 ; experiment 2 : n = 108 ) .
METHODS	The total amount of alcohol consumed during an experimental break ( observational data ) and questionnaire data on drinking patterns .
RESULTS	Self-control failure led to increased levels of drinking in males ( P < 0.05 ) , whereas females drank less after being depleted ( P < 0.01 ) .
RESULTS	Self-awareness , but not glucose , was found to counteract the effects of self-control failure among males ( P < 0.05 ) .
CONCLUSIONS	Self-control failure leads to increased drinking of alcohol in males and decreased levels of drinking alcohol in females .
CONCLUSIONS	However , increasing self-awareness appears to be a promising strategy in facing the temptation to drink when cognitive resources to inhibit intake are low .

###25881262
BACKGROUND	Access to fruit and vegetables ( FV ) is associated with adolescents ' FV consumption .
BACKGROUND	However , little is known about implementation of strategies to increase access to FV at schools .
BACKGROUND	We examined the implementation of two environmental components designed to increase access to FV at Danish schools .
METHODS	We used data from 20 intervention schools involved in the school-based multicomponent Boost trial targeting 13-year-olds ' FV consumption .
METHODS	The environmental components at school included daily provision of free FV and promotion of a pleasant eating environment .
METHODS	Questionnaire data was collected by the end of the nine-month intervention period among 1,121 pupils ( 95 % ) , from all school principals ( n = 20 ) and half way through the intervention period and by the end of the intervention among 114 teachers ( 44 % ) .
METHODS	The implementation of the components was examined descriptively using the following process evaluation measures ; fidelity , dose delivered , dose received and reach .
METHODS	Schools with stable high implementation levels over time were characterised by context , intervention appreciation and implementation of other components .
RESULTS	For all process evaluation measures , the level of implementation varied by schools , classes and over time .
RESULTS	Dose received : 45 % of pupils ( school range : 13-72 % , class range : 7-77 % ) ate the provided FV daily ; 68 % of pupils ( school range : 40-93 % , class range : 24-100 % ) reported that time was allocated to eating FV in class .
RESULTS	Reach : The intake of FV provided did not differ by SEP nor gender , but more girls and low SEP pupils enjoyed eating FV together .
RESULTS	Dose delivered : The proportion of teachers offering FV at a daily basis decreased over time , while the proportion of teachers cutting up FV increased over time .
RESULTS	Schools in which high proportions of teachers offered FV daily throughout the intervention period were characterized by being : small ; having a low proportion of low SEP pupils ; having a school food policy ; high teacher - and pupil intervention appreciation ; having fewer teachers who cut up FV ; and having high implementation of educational components .
CONCLUSIONS	The appliance of different approaches and levels of analyses to describe data provided comprehension and knowledge of the implementation process .
CONCLUSIONS	This knowledge is crucial for the interpretation of intervention effect .
BACKGROUND	Current Controlled Trials ISRCTN11666034 .

###24308540
OBJECTIVE	Garlic is effective against Candida species invitro , and along with other alternative therapies , is used by women with vulvovaginal candidiasis .
OBJECTIVE	The objective of this study was to ascertain whether oral garlic reduced vaginal candida counts during the second half of the menstrual cycle in asymptomatic women colonised with Candida species .
METHODS	A simple randomised double-blinded controlled trial .
METHODS	Melbourne , Australia .
METHODS	Sixty-three asymptomatic women who were culture-positive for Candida species at screening .
METHODS	Participants were randomised to three garlic tablets or placebo orally , twice daily , for 14days .
METHODS	The primary outcome was the proportion of women with colony counts of candida > 100 colony-forming units per ml in any given day during the last 7days before menstruation , defined as a ` case ' .
METHODS	Secondary outcomes included the mean quantitative colony counts of candida over 14days prior to menses .
RESULTS	There was no evidence of a difference between the proportion of cases in the garlic and placebo groups ( 76 versus 90 % ; relative risk , RR0 .85 ; 95 % confidence interval , 95 % CI 0.67-1 .08 ) , in the mean colony counts in both groups ( ratio of geometric means of candidal colony counts 0.63 ; 95 % CI 0.39-10 .03 ; P = 0.74 ) , or difference in the number of women reporting abnormal vaginal symptoms during the 2weeks before menstruation ( RR1 .03 ; 95 % CI 0.67-1 .58 ; P = 0.91 ) .
RESULTS	The garlic group reported more adverse effects ( 83 % compared 43 % in the placebo group ; difference in proportions 39 % ; 95 % CI 17 - % ; P < 0.01 ) .
CONCLUSIONS	This study provided data for sample size calculations in future studies on the antifungal effect of garlic , but provided no evidence to inform clinical practice regarding the use of garlic in vaginal candidiasis .
CONCLUSIONS	Further studies might investigate longer courses or topical formulations .

###25417130
OBJECTIVE	Evaluate the performance of a robotic system for CT-guided lung biopsy in comparison to the conventional manual technique .
METHODS	One hundred patients referred for CT-guided lung biopsy were randomly assigned to group A ( robot-assisted procedure ) or group B ( conventional procedure ) .
METHODS	Size , distance from entry point and position in lung of target lesions were evaluated to assess homogeneity differences between the two groups .
METHODS	Procedure duration , dose length product ( DLP ) , precision of needle positioning , diagnostic performance of the biopsy and rate of complications were evaluated to assess the clinical performance of the robotic system as compared to the conventional technique .
RESULTS	All biopsies were successfully performed .
RESULTS	The size ( p = 0.41 ) , distance from entry point ( p = 0.86 ) and position in lung ( p = 0.32 ) of target lesions were similar in both groups ( p = 0.05 ) .
RESULTS	Procedure duration and radiation dose were significantly reduced in group A as compared to group B ( p = 0.001 ) .
RESULTS	Precision of needle positioning , diagnostic performance of the biopsy and rate of complications were similar in both groups ( p = 0.05 ) .
CONCLUSIONS	Robot-assisted CT-guided lung biopsy can be performed safely and with high diagnostic accuracy , reducing procedure duration and radiation dose in comparison to the conventional manual technique .
CONCLUSIONS	CT-guided biopsy is the main procedure to obtain diagnosis in lung tumours .
CONCLUSIONS	The robotic device facilitates percutaneous needle placement under CT guidance .
CONCLUSIONS	Robot-assisted CT-guided lung biopsy reduces procedure duration and radiation dose .

###24744082
OBJECTIVE	To pilot-test the feasibility and preliminary effect of a community health worker ( CHW ) intervention to reduce hospital readmissions .
METHODS	Patient-level randomized quality improvement intervention .
METHODS	An academic medical center serving a predominantly low-income population in the Boston , Massachusetts area and 10 affiliated primary care practices .
METHODS	Medical service patients with an in-network primary care physician who were discharged to home ( n = 423 ) and had one of five risk factors for readmission within 30 days .
METHODS	Inpatient introductory visit and weekly post-discharge telephonic support for 4 weeks to assist patient in coordinating medical visits , obtaining and using medications , and in self-management .
METHODS	Number of completed CHW contacts ; CHW-reported barriers and facilitators to assisting patients ; primary care , emergency department and inpatient care use .
RESULTS	Roughly 70 % of patients received at least one post-discharge CHW call ; only 38 % of patients received at least four calls as intended .
RESULTS	Hospital readmission rates were lower among CHW patients ( 15.4 % ) compared with usual care ( 17.9 % ) ; the difference was not statistically significant .
CONCLUSIONS	Under performance-based payment systems , identifying cost-effective solutions for reducing hospital readmissions will be crucial to the economic survival of all hospitals , especially safety-net systems .
CONCLUSIONS	This pilot study suggests that with appropriate supportive infrastructure , hospital-based CHWs may represent a feasible strategy for improving transitional care among vulnerable populations .
CONCLUSIONS	An ongoing , randomized , controlled trial of a CHW intervention , developed according to the lessons of this pilot , will provide further insight into the utility of this approach to reducing readmissions .

###25104915
BACKGROUND	Fluid management in the perioperative period has been extensively studied but , despite that , `` the right amount '' still remains uncertain .
BACKGROUND	The purpose of this paper is to summarize the state of the art of intraoperative fluid approach today .
CONCLUSIONS	In the current medical literature there are only heterogeneous viewpoints that gives the idea of how confusing the situation is .
CONCLUSIONS	The approach to the intraoperative fluid management is complex and it should be based on human physiology and the current evidence .
CONCLUSIONS	An intraoperative restrictive fluid approach in major surgery may be beneficial while Goal-directed Therapy should be superior to the liberal fluid strategy .
CONCLUSIONS	Finally , we propose a rational approach currently used at our institution .

###24650024
OBJECTIVE	High primary stability is important for long-term survival of uncemented femoral stems .
OBJECTIVE	Different stem designs are currently in use .
OBJECTIVE	The ABG-I is a well-documented anatomical stem with a press-fit design .
OBJECTIVE	The Unique stem is designed for a tight customized fit to the cortical bone of the upper femur .
OBJECTIVE	This implant was initially developed for patients with abnormal anatomy , but the concept can also be used in patients with normal femoral anatomy .
OBJECTIVE	We present 5-year radiostereometric analysis ( RSA ) results from a randomized study comparing the ABG-I anatomical stem with the Unique femoral stem .
METHODS	100 hips with regular upper femur anatomy were randomized to either the ABG-I stem or the Unique femoral stem .
METHODS	RSA measurements were performed postoperatively and after 3 , 6 , 12 , 24 , and 60 months .
RESULTS	RSA measurements from 80 hips were available for analysis at the 5-year follow-up .
RESULTS	Small amounts of movement were observed for both stems , with no statistically significant differences between the 2 types .
CONCLUSIONS	No improvement in long-term stability was found from using a customized stem design .
CONCLUSIONS	However , no patients with abnormal geometry of the upper femur were included in this study .

###25392117
OBJECTIVE	Paracetamol / codeine has shown a strong analgesic activity in several studies conducted among different kind of subjects , including those with trauma .
OBJECTIVE	Nevertheless , its efficacy in patients accessing the Emergency Department ( ED ) for different kind of pain has never been tested .
METHODS	This is a cross-sectional , observational , prospective , cohort study .
METHODS	Inclusion criteria were patients > 18 year old presenting to the ED for localized traumatic or inflammatory pain involving only extremities .
METHODS	Numeric scale ( NRS ) was recorded thirty minutes and two hours after the administration of the analgesic therapy , consisting of 15 mg of ketorolac or 1000 mg/60 mg of paracetamol / codeine , both orally .
RESULTS	Two-hundred patients were consecutively enrolled ; 87 were treated with paracetamol/codeine and 113 with ketorolac .
RESULTS	The combination paracetamol/codeine resulted to be not inferior to ketorolac in non-traumatic pain group and trauma group ( p = 0.635 and p = 0.482 , respectively ) .
RESULTS	Compared to ketorolac , the combination paracetamol/codeine exerted a significantly higher analgesic activity in patients with fractures and muscular pain ( p = 0.044 ) and was more effective in acute pain ( p = 0.002 ) , with a significant effect two hours after the administration ( p = 0.029 ) .
CONCLUSIONS	Paracetamol/codeine is equivalent to ketorolac in non-traumatic pain and post-traumatic pain , but is superior in acute pain and in patients with fractures and muscular pain .
CONCLUSIONS	Those results play in favor of the use of the combination paracetamol/codeine in patients accessing the ED for non-traumatic or traumatic pain of the extremities .

###24574278
BACKGROUND	The purpose of this study was to objectively determine and compare the efficacy and effectiveness of xylitol solution ( Xlear Nasal Sprey ) compared with xylometazoline and physiological saline with respect to quality of life ( QoL ) in patients with nasal congestion .
METHODS	A prospective , randomized study was performed in 42 patients who had nasal obstruction and hypertrophied turbinate mucosa that was refractory to medical treatment .
METHODS	The study population was randomized into 3 groups according to the application of xylometazoline , physiological saline , and xylitol hyperosmolar solution .
METHODS	The efficacy of treatment was evaluated objectively ( 4-phase rhinomanometry ) and subjectively ( visual analogue scale VAS . )
METHODS	before and after the application of the nasal solutions .
METHODS	QoL was evaluated by means of Rhinoconjunctivitis Quality of Life Questionnaire ( RQLQ ) .
RESULTS	VAS scores and 4-phase rhinomanometry scores were better in the group treated with xylometazoline compared to those treated with xylitol or saline .
RESULTS	The xylitol procedure yielded better results than the saline procedure , but differences were not statistically significant in both objective and subjective evaluation methods .
RESULTS	For overall QoL , there was a significant improvement from baseline for the xylometazoline and xylitol groups .
RESULTS	However , the improvement in the xylometazoline group was significantly greater than that obtained in the xylitol group .
CONCLUSIONS	Xlear Nasal Spray is an effective modality in the treatment of nasal congestion and has positive effect on the QoL of patients .
CONCLUSIONS	Further studies are needed in order to plan an ongoing treatment of Xlear Nasal Sprey at certain intervals for continuous relief of symptoms and a better and longstanding QoL .

###24916786
OBJECTIVE	Frequent use and serious adverse effects related to non-steroidal anti-inflammatory drugs ( NSAIDs ) underscore the need to raise patient awareness about potential risks .
OBJECTIVE	Partial success of patient - or provider-based interventions has recently led to interest in combined approaches focusing on both patient and physician .
OBJECTIVE	This research tested a shared decision-making intervention for increasing patient-reported awareness of NSAID risk .
METHODS	A group randomized trial was performed in Alabama from 2005 to 2007 .
METHODS	Intervention group doctor practices received continuing medical education ( CME ) about NSAIDs and patient activation tools promoting risk assessment and communication during visits .
METHODS	Comparison group doctor practices received only CME .
METHODS	Cross-sectional data were collected before and after the intervention .
METHODS	Generalized linear latent and mixed models with logistic link tested relationships among the intervention , study phase , intervention by study phase interaction and patient-reported awareness of risks with either prescription or over-the-counter ( OTC ) NSAIDs .
RESULTS	Three hundred and forty-seven patients at baseline and 355 patients at follow-up participated in this study .
RESULTS	The intervention [ adjusted odds ratio ( AOR ) = 0.74 , P = 0.248 ] , follow-up study phase ( AOR = 1.31 , P = 0.300 ) and intervention by study phase interaction ( AOR = 0.98 , P = 0.942 ) were not significantly associated with patient-reported awareness of any prescription NSAID risk .
RESULTS	Follow-up study phase was associated with increased odds of reporting any OTC NSAID risk awareness ( AOR = 2.99 , P < 0.001 ) , but the patient activation intervention and intervention by study phase interaction were not significantly associated with patient-reported awareness of any OTC NSAID risk ( AOR = 0.98 , P = 0.929 ; AOR = 0.87 , P = 0.693 , respectively ) .
CONCLUSIONS	Our point-of-care intervention encouraging shared decision making did not increase NSAID risk awareness .

###24810262
BACKGROUND	Delirium is common after cardiac surgery and may be partly related to the systemic inflammatory response triggered by the surgery and the use of cardiopulmonary bypass .
BACKGROUND	We hypothesized that intraoperative administration of high-dose dexamethasone , a drug with potent anti-inflammatory effects , would reduce the incidence of delirium at any time point during the first 4 postoperative days after cardiac surgery .
METHODS	This was a single-center substudy within a larger , multicenter placebo-controlled randomized clinical trial , the Dexamethasone for Cardiac Surgery ( DECS ) trial that randomized patients 18 years , undergoing cardiac surgery with cardiopulmonary bypass , to receive , in a double-blind fashion , either dexamethasone 1 mg/kg or placebo at the induction of anesthesia .
METHODS	Over the first 4 postoperative days , we compared between groups the incidence of delirium ( based on the Confusion Assessment Method adapted for the intensive care unit , or after intensive care unit discharge , by the Confusion Assessment Method , accompanied by chart review ) , restraint use , and administered haloperidol , benzodiazepines , and opioids .
METHODS	Data were analyzed according to the intention-to-treat principle .
METHODS	The proportion of patients with delirium in the dexamethasone versus the placebo group was compared using the odds ratio ( OR ) with a 95 % confidence interval ( CI ) .
METHODS	The proportion also was compared using logistic regression to adjust for common baseline variables that might confound the presence of delirium between the 2 groups .
RESULTS	Of 768 eligible patients , 737 subjects ( 96.0 % ) had complete data .
RESULTS	The incidence of delirium was similar between the dexamethasone ( 14.2 % ) and placebo ( 14.9 % ) groups ( crude OR = 0.95 , 95 % CI , 0.63-1 .43 ; adjusted OR = 0.85 , 95 % CI , 0.55-1 .31 ) .
RESULTS	Among patients who developed delirium , the median ( interquartile range ) duration of delirium was similar between the dexamethasone and placebo groups ( 2 [ 1-3 ] vs 2 [ 1-2 ] days , respectively , P = 0.45 ; WMWodds 0.98 , 95 % CI , 0.83-1 .17 ) .
RESULTS	Restraint use and the administration of haloperidol , benzodiazepines , and opioids were also similar between the 2 groups .
CONCLUSIONS	The intraoperative administration of dexamethasone did not reduce the incidence or duration of delirium in the first 4 days after cardiac surgery .

###24407896
BACKGROUND	Intraoperative awareness ( IA ) is diagnosed when patients can recall their surroundings or an event related to the surgery that occurred while they were under general anaesthesia .
BACKGROUND	The female gender and Caesarean section are considered to be contributing factors .
BACKGROUND	The aim of the present study was to analyse the frequency of IA in patients undergoing general anaesthesia either for Caesarean section or gynaecological procedures .
METHODS	ASA I and II women were included into the study .
METHODS	Patients were randomly allocated to 4 groups : A , B and C included patients qualified for elective gynaecological surgery , and group D comprised Caesarean section patients .
METHODS	Premedication was not given .
METHODS	Group A received total intravenous anaesthesia with TCI , and groups B , C and D received balanced anaesthesia .
METHODS	The depth of anaesthesia was monitored with an AEP monitor .
METHODS	Blinded structured interviews were conducted 2 hours after anaesthesia and on postoperative days 7 and 30 .
RESULTS	337 patients were enrolled into the study .
RESULTS	45 patients reported diverse sensations connected to the anaesthesia ( Group A - 7 patients , B - 9 patients , C - 2 patients , D - 28 patients ) .
RESULTS	There were mainly dream sensations , but IA was present in 3 cases .
RESULTS	In all of the cases , IA was recognised during the first interview .
RESULTS	One episode of awareness appeared in group B , and the other two appeared in group D.
RESULTS	One Caesarean section was complicated by intraoperative haemorrhage .
RESULTS	The patient from group B had similar sensations during previous anaesthesia .
RESULTS	Two women enrolled in the study reported awareness in the past , which did not occur this time .
CONCLUSIONS	Awareness during general anaesthesia occurs occasionally .
CONCLUSIONS	The frequency of occurrence in a group of patients undergoing general anaesthesia for uncomplicated Caesarean section is not higher than for other procedures .
CONCLUSIONS	The anaesthesia for Caesarean section , as well as for other procedures , may be accompanied by pleasant dreams .

###25073833
BACKGROUND	This study tests whether the genetic predictor ( CHRNA5 nicotine receptor gene variants ) and an environmental risk factor ( partner smoking ) interact in the prediction of smoking reduction .
METHODS	Subjects were from a community-based , longitudinal study of women ( n = 1856 ) who smoked before pregnancy , and a randomized comparative effectiveness smoking cessation trial ( n = 1065 ) .
METHODS	Smoking reduction was defined as the trajectory of self-reported smoking quantities over time in the observational study , and as the trajectory of alveolar CO levels in the cessation trial .
RESULTS	In the pregnancy study , rs16969968 genotype and partner smoking status interacted such that the smoking reduction was lowest for expectant mothers with high genetic risk and partner smoking , and highest for those with high genetic risk but not partner smoking ( interaction of genotypepartner smoking on smoking quantity trajectory slope = 0.071 , 95 % CI = 0.013 , 0.13 , p = 0.017 ) .
RESULTS	In the clinical trial , a similar interaction was found ( interaction = 0.20 , 95 % CI = 0.049 , 0.36 , p = 0.010 ) .
RESULTS	Furthermore , these associations were moderated by pharmacotherapy such that the interactive relation of genetic and environmental factors occurred in the placebo group , but not in the active pharmacotherapy group ( interaction of genotypepartner smokingpharmacotherapy on CO trajectory slope = -0.25 , 95 % CI = -0.42 , -0.091 , p = 0.0023 ) .
CONCLUSIONS	The CHRNA5 genetic risk synergized the effect of partner smoking , producing an especially low likelihood of successful smoking reduction in two complementary studies .
CONCLUSIONS	This suggests that the genetic vulnerability may be mitigated by altering environmental factors .
CONCLUSIONS	In addition , cessation pharmacotherapy neutralizes the increase in cessation failure associated with combined genetic and environmental risks , which has possible relevance to treatment algorithms .

###24284470
BACKGROUND	Considering the extensive neural network of the oculomotor subsystems , traumatic brain injury ( TBI ) could affect oculomotor control and related reading dysfunction .
OBJECTIVE	To evaluate comprehensively the effect of oculomotor-based vision rehabilitation ( OBVR ) in individuals with mTBI .
METHODS	Twelve subjects with mTBI participated in a cross-over , interventional study involving oculomotor training ( OMT ) and sham training ( ST ) .
METHODS	Each training was performed for 6 weeks , 2 sessions a week .
METHODS	During each training session , all three oculomotor subsystems ( vergence/accommodation/version ) were trained in a randomized order across sessions .
METHODS	All laboratory and clinical parameters were determined before and after OMT and ST. In addition , nearvision-related symptoms using the Convergence Insufficiency Symptom Survey ( CISS ) scale and subjective visual attention using the Visual Search and Attention Test ( VSAT ) were assessed .
RESULTS	Following the OMT , over 80 % of the abnormal parameters significantly improved .
RESULTS	Reading rate , along with the amplitudes of vergence and accommodation , improved markedly .
RESULTS	Saccadic eye movements demonstrated enhanced rhythmicity and accuracy .
RESULTS	The improved reading-related oculomotor behavior was reflected in reduced symptoms and increased visual attention .
RESULTS	None of the parameters changed with ST.
CONCLUSIONS	OBVR had a strong positive effect on oculomotor control , reading rate , and overall reading ability .
CONCLUSIONS	This oculomotor learning effect suggests considerable residual neuroplasticity following mTBI .

###24720399
BACKGROUND	Epidemiological studies of the association between bisphenol A ( BPA ) exposure and diabetes have been inconsistent .
BACKGROUND	The present study determined serum BPA concentrations in the Thai population and their association with hyperglycemia and diabetes .
METHODS	In all , 2581 serum samples from the Thai National Health Examination Survey ( 2009 ) were used to determine BPA levels .
METHODS	Impaired fasting glucose ( IFG ) was defined as fasting plasma glucose 100 and < 126mg/dL .
METHODS	Diabetes was defined as a history of a physician 's diagnosis or fasting plasma glucose 126mg/dL .
METHODS	Multinomial logistic regression was used to examine the association of serum BPA with IFG and diabetes .
RESULTS	Of 2581 samples tested , BPA was detected in 2135 samples ( weighted percentage 78.1 % ) , with a geometric mean concentration of 0.34 ng/mL BPA .
RESULTS	Serum BPA levels were significantly higher among those with diabetes or IFG compared with normoglycemic individuals ( 0.52 and 0.38 vs 0.33 ng/mL , respectively ; P < 0.001 ) .
RESULTS	After adjusting for potential confounders , compared with the first quartile ( 0.071 ng/mL ) , the overall adjusted odds ratios ( OR ) of serum BPA concentration in the third and fourth quartiles ( 0.319-0 .745 and 0.746 ng/mL , respectively ) for IFG were 1.72 ( 95 % confidence interval [ CI ] 1.19 , 2.49 ) and 1.23 ( 95 % CI 0.80 , 1.89 ) , respectively ; for diabetes , the adjusted OR were 1.88 ( 95 % CI 1.18 , 2.99 ) and 1.83 ( 95 % CI 1.12 , 2.95 ) , respectively , with a slightly stronger association among men than in women .
CONCLUSIONS	Serum BPA concentrations were not associated with IFG , but were positively associated with diabetes in the Thai population .
CONCLUSIONS	Further prospective studies are needed to confirm the relationship .

###24955610
BACKGROUND	Reduced arterial elasticity contributes to an obesity-related increase in cardiovascular risk in adults .
OBJECTIVE	To evaluate the effect of fat loss on arterial elasticity in obese adolescents at risk of type 2 diabetes .
METHODS	A secondary data analysis of the RESIST study was performed in two hospitals in Sydney , Australia .
METHODS	The study included 56 subjects ( ages , 10 to 17 y ; 25 males ) with prediabetes and/or clinical features of insulin resistance .
METHODS	A 12-month lifestyle plus metformin intervention .
RESULTS	Arterial elasticity and systemic vascular resistance were measured using radial tonometry pulse contour analysis , percentage body fat ( % BF ) was measured by dual-energy x-ray absorptiometry , and insulin sensitivity index was derived from an oral glucose tolerance test and lipids .
RESULTS	Adolescents ( n = 31 ) with decreased % BF ( mean change [ range ] , -4.4 % [ -18.3 to -0.01 % ] ) after the intervention had significant increases in the mean large arterial elasticity index ( mean change [ 95 % CI ] , 5.1 [ 1.9 to 8.2 ] mL/mm Hg * 10 ; P = .003 ) and insulin sensitivity index ( 0.5 [ 0.1 to 0.9 ] ; P = .010 ) and a decrease in systemic vascular resistance ( -82 [ -129 to -35 ] dyne * s * cm ( -5 ) ; P = .001 ) .
RESULTS	There were no significant changes in these parameters in adolescents who increased their % BF .
RESULTS	Nor was there any significant change in the mean small arterial elasticity index in either group .
CONCLUSIONS	Long-term follow-up of these adolescents is warranted to assess whether the observed changes in vascular elasticity will lead to a clinical benefit including reduced cardiovascular morbidity and mortality .

###24989831
OBJECTIVE	The Lifestyle in Pregnancy intervention in obese pregnant women resulted in significantly lower gestational weight gain compared with the control group , but without improvement in rates of clinical pregnancy complications .
OBJECTIVE	The impact of the lifestyle intervention on metabolic measurements in the study participants is now reported .
METHODS	The Lifestyle in Pregnancy study was a randomized controlled trial among 360 obese women ( BMI 30-45 kg/m ) who were allocated in early pregnancy to lifestyle interventions with diet counselling and physical activities or to the control group .
METHODS	Fasting blood samples , including plasma glucose , insulin , lipid profile and capillary blood glucose during a 2-h oral glucose tolerance test were carried out three times throughout pregnancy .
METHODS	Insulin resistance was estimated with the homeostasis model assessment of insulin resistance .
RESULTS	Three hundred and four women ( 84 % ) were followed until delivery .
RESULTS	Women in the intervention group had a significantly lower change in insulin resistance ( HOMA-IR ) from randomization to 28-30 weeks ' gestation compared with control subjects ( mean SD : 0.7 1.3 vs. 1.0 1.3 , P = 0.02 ) .
RESULTS	Despite a significantly lower gestational weight gain in the intervention group , there was no difference between the groups with respect to total cholesterol , HDL , LDL or triglycerides .
CONCLUSIONS	Lifestyle intervention in obese pregnant women resulted in attenuation of the physiologic pregnancy-induced insulin resistance .
CONCLUSIONS	Despite restricted gestational weight gain , there were no changes in glucose or lipid metabolism between the groups .

###26035199
OBJECTIVE	Phototherapy , ie , bright light therapy , is an effective and safe treatment of major depressive disorder ( MDD ) .
OBJECTIVE	It exerts rapid mood-elevating activity , similar to antidepressant medications , most likely mediated through both monoaminergic and circadian system melatonergic mechanisms .
OBJECTIVE	We assessed the efficiency of bright light therapy as an adjuvant treatment to antidepressant pharmacotherapy in patients with severe MDD randomized by Hamilton Depression Rating Scale ( HDRS ) score to either ( 1 ) 150 mg venlafaxine hydrochloride daily at 7:00 AM or ( 2 ) 150 mg venlafaxine plus 60-minute light of 7000 lux the initial week of clinical management ( venlafaxine + bright light therapy ) daily at 7:00 AM .
METHODS	50 inpatients with severe MDD at the Psychiatry Clinic of Yznc Yl University Training and Education Hospital participated .
METHODS	The study , which was conducted from January 2013 through June 2014 , entailed patients diagnosed with severe MDD based on DSM-IV-TR for the first time .
METHODS	Mood states were assessed by the HDRS , Profile of Mood States ( POMS ) , and Beck Depression Inventory ( BDI ) before treatment and at 1 , 2 , 4 , and 8 weeks of treatment .
RESULTS	On the basis of the HDRS score as the primary outcome variable , both strategies significantly improved depression and negative mood states already at the first treatment week ( P < .001 ) .
RESULTS	Differences in therapeutic effects by treatment strategy were remarkable at the second and fourth weeks of clinical management ( P = .018 and P = .011 , respectively ) , with beneficial effects continuing until trial conclusion .
RESULTS	Those treated with venlafaxine + bright light therapy evidenced significantly lower HDRS depression scores ( P < .05 ) as well as BDI scores ( P < .05 ) and POMS negative mood states scores ( depression-dejection , tension-anxiety , anger-hostility , fatigue-inertia , and confusion-bewilderment subscales ; all P < .05 ) after the second week .
RESULTS	At week 4 of the trial , 19 ( 76 % ) of the 25 venlafaxine + bright light therapy patients versus just 11 ( 44 % ) of the 25 venlafaxine patients ( P < .05 ) attained the target goal of treatment , a HDRS score 13 , indicative of mild depression , and , although not statistically significant in our small sample study ( P = .36 ) , at week 8 , 76 % of venlafaxine + bright light therapy patients ( n = 19 ) versus just 64 % of the venlafaxine patients ( n = 16 ) experienced complete remission of depression ( HDRS score 7 ) .
CONCLUSIONS	Both venlafaxine and venlafaxine + bright light therapy treatment strategies significantly reversed the depressive mood of patients with severe MDD ; however , the latter induced significantly stronger and more rapid beneficial effects .
CONCLUSIONS	Future longer-term studies with large sample sizes , nonetheless , are required to confirm and generalize these results to patients of diverse ethnicities and cultures with both severe and mild MDD .
BACKGROUND	ANZCTR.org.au registration number : ACTRN12614001061628 .

###24589724
BACKGROUND	Diabetic nephropathy ( DN ) is one of the major late complications of diabetes .
BACKGROUND	Treatment aimed at slowing down the progression of DN is available but methods for early and definitive detection of DN progression are currently lacking .
BACKGROUND	The ` Proteomic prediction and Renin angiotensin aldosterone system Inhibition prevention Of early diabetic nephRopathy In TYpe 2 diabetic patients with normoalbuminuria trial ' ( PRIORITY ) aims to evaluate the early detection of DN in patients with type 2 diabetes ( T2D ) using a urinary proteome-based classifier ( CKD273 ) .
METHODS	In this ancillary study of the recently initiated PRIORITY trial we aimed to validate for the first time the CKD273 classifier in a multicentre ( 9 different institutions providing samples from 165 T2D patients ) prospective setting .
METHODS	In addition we also investigated the influence of sample containers , age and gender on the CKD273 classifier .
RESULTS	We observed a high consistency of the CKD273 classification scores across the different centres with areas under the curves ranging from 0.95 to 1.00 .
RESULTS	The classifier was independent of age ( range tested 16-89 years ) and gender .
RESULTS	Furthermore , the use of different urine storage containers did not affect the classification scores .
RESULTS	Analysis of the distribution of the individual peptides of the classifier over the nine different centres showed that fragments of blood-derived and extracellular matrix proteins were the most consistently found .
CONCLUSIONS	We provide for the first time validation of this urinary proteome-based classifier in a multicentre prospective setting and show the suitability of the CKD273 classifier to be used in the PRIORITY trial .

###24486687
OBJECTIVE	To compare the analgesic efficacy and rate of wound healing of combination of 0.2 % Glyceryl Trinitrate and 2 % lignocaine ointments with 0.2 % Glyceryl Trinitrate and 2 % lignocaine ointment separately after Milligan Morgan hemorrhoidectomy .
METHODS	Randomized control trial .
METHODS	Combined Military Hospital , Kharian , Malir and Bannu .
METHODS	November 2007 to August 2011 .
METHODS	Patients undergoing Milligan Morgan hemorrhoidectomy were randomized into 3 groups by using computer generated table .
METHODS	Group A received combination of 0.2 % Glyceryl Trinitrate and 2 % lignocaine ointment , Group B 2 % lignocaine and Group C received 0.2 % Glyceryl Trinitrate ointment .
METHODS	These ointments were given on twice daily basis .
METHODS	Pain scores were measured on a 100mm Visual Analog Scale .
METHODS	Pain scores and quantity of oral analgesics used were compared daily until the 7th post-operative day .
METHODS	The time required for complete healing ( in weeks ) was also compared .
RESULTS	Out of 210 patients , 192 ( 67 Group A , 64 Group B and 61 Group C ) completed the study .
RESULTS	Demographic data were comparable in all three groups .
RESULTS	There were statistically significant reductions in pain scores and quantity of analgesics used from the first to the fourth post-operative days in Group A.
RESULTS	The time required for complete healing was also significantly reduced in the combination group .
RESULTS	There were no significant side effects in any group .
CONCLUSIONS	The combination of 0.2 % GTN and 2 % lignocaine showed better pain relief resulting in less use of oral analgesics and faster healing of the wound after Milligan Morgan hemorrhoidectomy .

###24652170
BACKGROUND	Iron depleted deposits are the first link in the chain of events leading to iron deficiency which is the most prevalent nutritional shortage and main cause of anemia worldwide .
BACKGROUND	This situation can be prevented through food fortification .
OBJECTIVE	To compare the efficacy of amino acid chelate iron with ferrous sulfate as fortifier of a dietary complement in preschoolers with iron deficiency .
METHODS	This study was a blinded clinical trial with randomized groups .
METHODS	We analyzed 56 preschoolers with iron deficiency ( ferritin < 24 ng/ml ) that received 13 g of milk with 12.5 mg of iron , either amino acid chelate or in the ferrous sulfate form .
METHODS	After two months , hemoglobin , hematocrit and serum ferritin concentrations were measured .
RESULTS	In the ferrous sulfate group , ferritin concentration increased from 18.8 ng/ml to 24.1 ng/ml , while the variation was of 18.4 ng/ml to 29.7 ng/ml in the amino acid chelate group , with statistically differences in both cases .
RESULTS	Serum ferritin was different between groups , being higher in iron amino acid chelate group ( p = 0.022 ) .
RESULTS	Hemoglobin and hematocrit levels did not change after the intervention .
RESULTS	Adverse reactions in the ferrous sulfate group were 35.7 % , compared with 42.9 % in the iron amino acid chelate group ; 5 children had respiratory tract infection , without statistical differences .
CONCLUSIONS	Both compounds increased serum ferritin concentration , with a higher increase in those who were given milk with iron amino acid chelate .
CONCLUSIONS	There were no differences in the adverse reactions and infections incidences between the groups .

###25560821
OBJECTIVE	The purpose of this pilot study was to begin to examine the effect of dietary protein source ( soy protein versus non-soy protein ) during weight loss on body composition , and cardiometabolic and functional decline risk factors in older , abdominally obese adults .
METHODS	Two-arm , single-blind , randomized , controlled trial .
METHODS	Wake Forest School of Medicine , Winston-Salem NC 27157 , USA .
METHODS	25 older ( 68.45.5 years , 88 % female ) , abdominally obese ( BMI : 35.14.3 kg/m2 ; WC : 101.413.1 cm ) men and women were randomized to participate in the study .
METHODS	A 12-week weight loss intervention , with participants randomized to consume soy protein-based meal replacements ( S ; n = 12 ) or non-soy protein-based meal replacements ( NS ; n = 12 ) , in addition to prepared meals , and all participants targeted to receive an individualized caloric deficit of 500 kcal/day .
METHODS	Body weight and composition ( assessed via DXA and CT ) , conventional biomarkers of cardiometabolic risk , and physical performance measures were assessed pre - and post-intervention .
METHODS	Additional endpoints of feasibility ( accrual , participation , retention , compliance , and safety ) are reported .
RESULTS	A total of 24 participants ( 87 % female ) completed the study ( 96 % retention ) and lost an average of 7.83.0 kg over the 12-week period , with no difference seen between groups ( p = 0.83 ) .
RESULTS	Although nearly all measures of global and regional body composition were significantly reduced following the 12-week intervention , differences were not observed between groups .
RESULTS	Among cardiometabolic risk factors and physical performance measures , only diastolic blood pressure was significantly lower in the NS group compared to the S group ( 66.72.7 mmHg vs 73.52.7 mmHg , respectively ; p = 0.04 ) .
RESULTS	Interestingly , in groups combined , despite significant reductions in body weight and lean mass , no significant changes in 400-meter walk time ( +5.343.4 s ) , short physical performance battery score ( +0.11.0 ) , grip strength ( -0.33.2 kg ) , or relative knee extensor strength ( -0.00.0 N/m/cm3 thigh muscle volume ) were observed .
CONCLUSIONS	Data presented here suggest that a 12-week weight loss intervention , which incorporates S and NS meal replacement products , is associated with clinically significant weight loss and improvements in several parameters of cardiometabolic risk and unchanged physical function and strength .
CONCLUSIONS	RESULTS do not differ by protein source and suggest that soy protein is at least as good as other protein sources for weight loss during low-calorie dietary interventions in older adults .

###25129515
BACKGROUND	Long-lasting insecticidal nets ( LLINs ) have limited effect on malaria transmitted outside of sleeping hours .
BACKGROUND	Topical repellents have demonstrated reduction in the incidence of malaria transmitted in the early evening .
BACKGROUND	This study assessed whether 15 % DEET topical repellent used in combination with LLINs can prevent greater malaria transmission than placebo and LLINs , in rural Tanzania .
METHODS	A cluster-randomized , placebo-controlled trial was conducted between July 2009 and August 2010 in a rural Tanzanian village .
METHODS	Sample size calculation determined that 10 clusters of 47 households with five people/household were needed to observe a 24 % treatment effect at the two-tailed 5 % significance level , with 90 % power , assuming a baseline malaria incidence of one case/person/year .
METHODS	Ten clusters each were randomly assigned to repellent and control groups by lottery .
METHODS	A total of 4,426 individuals older than six months were enrolled .
METHODS	All households in the village were provided with an LLIN per sleeping space .
METHODS	Repellent and placebo lotion was replaced monthly .
METHODS	The main outcome was rapid diagnostic test ( RDT ) - confirmed malaria measured by passive case detection ( PCD ) .
METHODS	Incidence rate ratios were estimated from a Poisson model , with adjustment for potential confounders , determined a priori .
METHODS	According-to-protocol approach was used for all primary analyses .
RESULTS	The placebo group comprised 1972.3 person-years with 68.29 ( 95 % C.I 37.05-99 .53 ) malaria cases/1 ,000 person-years .
RESULTS	The repellent group comprised 1,952.8 person-years with 60.45 ( 95 % C.I 48.30-72 .60 ) cases/1 ,000 person-years , demonstrating a non-significant 11.44 % reduction in malaria incidence rate in this group , ( Wilcoxon rank sum z = 0.529 , p = 0.596 ) .
RESULTS	Principal components analysis ( PCA ) of the socio-economic status ( SES ) of the two groups demonstrated that the control group had a higher SES ( Pearson 's chi square = 13.38 , p = 0.004 ) .
CONCLUSIONS	Lack of an intervention effect was likely a result of lack of statistical power , poor capture of malaria events or bias caused by imbalance in the SES of the two groups .
CONCLUSIONS	Low malaria transmission during the study period could have masked the intervention effect and a larger study size was needed to increase discriminatory power .
CONCLUSIONS	Alternatively , topical repellents may have no impact on malaria transmission in this scenario .
CONCLUSIONS	Design and implementation of repellent intervention studies is discussed .
BACKGROUND	The trial was registered ISRCTN92202008 -- http://www.controlled-trials.com/ISRCTN92202008 .

###24861540
BACKGROUND	Considerable evidence suggests that performance across a variety of cognitive tasks is effectively supported by the use of verbal and nonverbal strategies .
BACKGROUND	Studies exploring the usefulness of such strategies in children with specific language impairment ( SLI ) are scarce and report inconsistent findings .
OBJECTIVE	To examine the effects of induced labelling and auditory cues on the performance of children with and without SLI during a categorization task .
METHODS	Sixty-six school-age children ( 22 with SLI , 22 age-matched controls , 22 language-matched controls ) completed three versions of a computer-based categorization task : one baseline , one requiring overt labelling and one with auditory cues ( tones ) on randomized trial blocks .
RESULTS	Labelling had no effect on performance for typically developing children but resulted in lower accuracy and longer reaction time in children with SLI .
RESULTS	The presence of tones had no effect on accuracy but resulted in faster reaction time and post-error slowing across groups .
CONCLUSIONS	Verbal strategy use was ineffective for typically developing children and negatively affected children with SLI .
CONCLUSIONS	All children showed faster performance and increased performance monitoring as a result of tones .
CONCLUSIONS	Overall , effects of strategy use in children appear to vary based on task demands , strategy domain , age and language ability .
CONCLUSIONS	Results suggest that children with SLI may benefit from auditory cues in their clinical intervention but that further research is needed to determine when and how verbal strategies might similarly support performance in this population .

###25539255
OBJECTIVE	The unenhanced MR angiography ( MRA ) technique time-spatial labeling inversion pulse ( time-SLIP ) may provide a safe alternative for evaluating the renal arteries for stenosis .
OBJECTIVE	This international multicenter trial tested the hypothesis that time-SLIP unenhanced MRA is accurate and robust for assessing the renal arteries for stenosis in comparison with contrast-enhanced CT angiography ( CTA ) .
METHODS	Four centers ( United States , Europe , Asia ) enrolled 75 patients ( average age SD , 58 13 years ; 41 [ 55 % ] men and 34 [ 45 % ] women ) .
METHODS	Each patient underwent abdominal contrast-enhanced CTA and abdominal unenhanced MRA using time-SLIP with balanced steady-state free precession .
METHODS	All images were visually assessed for quality ( arterial signal intensity ) and for the absence or presence of renal artery stenosis ( 50 % or > 50 % stenosis , respectively ) .
METHODS	In addition , for arteries with any visible disease , the severity of the stenosis was quantified .
METHODS	Two blinded readers evaluated each study .
METHODS	No arteries were excluded from analysis .
RESULTS	Unenhanced MRA image quality was excellent for 56 of 75 patients ( 75 % ) and good for 16 of 75 patients ( 21 % ) .
RESULTS	CTA was used as the reference standard and showed that 23 of 161 renal arteries ( 14.3 % ) had stenosis > 50 % .
RESULTS	Unenhanced MRA correctly classified 17 of the 23 renal arteries with > 50 % stenosis and correctly classified 128 of the 138 renal arteries as not having disease ( 50 % stenosis ) to yield a sensitivity of 74 % , specificity of 93 % , and accuracy of 90 % ( ( 2 ) = 0.56 ; p = 0.45 , no statistically significant difference ) .
RESULTS	Of the 16 misclassified arteries , only three had a clinically relevant misclassification ( CTA 70 % stenosis and unenhanced MRA 50 % stenosis or unenhanced MRA 70 % stenosis and CTA 50 % stenosis ) .
RESULTS	On average , measured stenotic severity ( n = 28 arteries ) was similar for unenhanced MRA ( 64 % 17 % ) and CTA ( 62 % 16 % ) ( p = 0.51 ) .
CONCLUSIONS	Compared with contrast-enhanced CTA , the unenhanced MRA technique time-SLIP shows promise for assessing the renal arteries for stenosis .
CONCLUSIONS	The unenhanced MRA technique time-SLIP may provide a safe alternative for evaluating the renal arteries for stenosis .

###24988203
OBJECTIVE	Although previous studies assessed the effects of Serenoa repens , quercetin and - sitosterol on inflammatory parameters , no randomized studies have tested the combination of these agents neither on BPH symptoms nor on the inflammatory pattern .
OBJECTIVE	The aim of this trial was to evaluate the effects of Difaprost on voiding dysfunction , histological inflammatory alterations and apoptotic molecular mechanisms in BPH patients .
METHODS	We included 36 patients affected by BPH with obstructive symptoms eligible for surgery .
METHODS	Patients were randomly assigned to two groups : 18 patients received Difaprost for three months before surgery , and 18 patients did not receive any additional therapy and were scheduled for surgery .
METHODS	All patients receiving Difaprost were evaluated with uroflowmetry with post-void residual volume ( PVR ) evaluation , serum PSA , and IPSS questionnaire before and after treatment .
METHODS	Moreover , we evaluated inflammatory patterns in prostatic specimens at final pathology .
RESULTS	Even without statistically significant differences on inflammatory pattern between patients receiving Difaprost and controls , patients receiving Difaprost had lower presence of edema and angiectasia at histological evaluation of prostate specimens .
RESULTS	Moreover , patients included in the treatment group had a clinically significant reduction of PVR ( 46.1 vs. 25.2 mL ; P = 0.1 ) and a slight increase in Qmed ( 5.6 vs. 6.5 mL/s ; P = 0.9 ) after three months of chronic treatment with Difaprost .
RESULTS	No statistically significant differences were recorded in other clinical parameters between patients receiving Difaprost and controls .
CONCLUSIONS	Although not statistically significant , patients treated with Difaprost showed an improvement in voiding function compared to controls ( namely , an increase in Qmed and a reduction of PVR ) .
CONCLUSIONS	Future trials with a larger number of patients and a longer treatment period could be necessary to evaluate the clinical efficacy of Difaprost .

###24961647
OBJECTIVE	To compare the long-term outcomes of a tension-free vaginal tape ( TVT ; Gynecare , Somerville , NJ , USA ) , autologous fascial sling ( AFS ) and xenograft sling ( porcine dermis , Pelvicol ; Bard , Murray Hill , NJ , USA ) in the management of female stress urinary incontinence ( SUI ) .
METHODS	A multicentre randomised controlled trial carried out in four UK centres from 2001 to 2006 involving 201 women requiring primary surgery for SUI .
METHODS	The women were randomly assigned to receive TVT , AFS or Pelvicol .
METHODS	The primary outcome was surgical success defined as ` women reporting being completely ` dry ' or ` improved ' at the time of follow-up ' .
METHODS	The secondary outcomes included ` completely dry ' rates , changes in the Bristol Female Lower Urinary Tract Symptoms ( BFLUTS ) and EuroQoL EQ-5D questionnaire scores .
RESULTS	In all , 162 ( 80.6 % ) women were available for follow-up with a median ( range ) duration of 10 ( 6.6-12 .6 ) years .
RESULTS	` Success ' rates for TVT , AFS and Pelvicol were 73 % , 75.4 % and 58 % , respectively .
RESULTS	Comparing the 1 - and 10-year ` success ' rates , there was deterioration from 93 % to 73 % ( P < 0.05 ) in the TVT arm and 90 % to 75.4 % ( P < 0.05 ) in the AFS arm ; ` dry ' rates were 31.7 % , 50.8 % and 15.7 % , respectively .
RESULTS	Overall , the ` dry ' rates favoured AFS when compared with Pelvicol ( P < 0.001 ) and TVT ( P = 0.036 ) .
RESULTS	The re-operation rate for persistent SUI was 3.2 % ( two patients ) in the TVT arm , 13.1 % ( five ) in the Pelvicol arm , while none of the patients in the AFS arm required further intervention .
CONCLUSIONS	Our study indicates there is not enough evidence to suggest a difference in long-term success rates between AFS and TVT .
CONCLUSIONS	However , there is some evidence that ` dry ' rates for AFS may be more durable than TVT .

###25842559
OBJECTIVE	To evaluate and compare the long-term outcome of unstable thoracolumbar burst fractures treated using anterior , posterior or combined anterior and posterior approaches .
METHODS	The prospective randomised controlled study was conducted at the Tianjin 4th Centre Hospital , Tianjin , China , and comprised patients of unstable thoracolumbar burst fracture operated between July 2004 and July 2006 and followed up for five years .
METHODS	The patients were divided randomly into three groups of anterior , posterior and combined anterior and posterior approaches .
METHODS	Clinical data was analysed using SPSS 17 .
RESULTS	Of the 66 cases in the study , 45 ( 68.18 % ) were male and 21 ( 31.8 % ) were female , with overall age ranging from 19 to 69 years .
RESULTS	There were 22 ( 33.3 % ) patients in the anterior group , 23 ( 35 % ) in the posterior group , and 21 ( 32 % ) in the combined anterior and posterior group .
RESULTS	Comparison was made between two respective groups .
RESULTS	The combined group was found to have the longest operation time ( p < 0.02 ; p < 0.01 , respectively ) , larger blood loss ( p < 0.006 ; p < 0.005 , respectively ) , longer hospital stay ( p < 0.01 ; p < 0.003 , respectively ) and higher hospitalisation costs ( p < 0.004 ; p < 0.001 , respectively ) .
RESULTS	The postoperative kyphotic angle was significantly smaller than preoperative one in all groups ( p < 0.01 ; p < 0.02 ; p < 0.01 ) .
CONCLUSIONS	The anterior approach or combined anterior and posterior approach were better options in managing unstable thoracolumbar burst fracture , while the latter should be used only for the burst fracture with a significant posterior column injury .

###24563518
BACKGROUND	Cervical cancer is the leading cause of cancer mortality among women in India .
BACKGROUND	Because Pap smear screening is not feasible in India , we need to develop effective alternatives .
METHODS	A cluster-randomized controlled study was initiated in 1998 in Mumbai , India , to investigate the efficacy of visual inspection with acetic acid ( VIA ) performed by primary health workers in reducing cervical cancer mortality .
METHODS	Four rounds of cancer education and VIA screening were conducted at 24-month intervals in the screening group , whereas cancer education was offered once at entry to the control group .
METHODS	The study was planned for 16 years to include four screening rounds followed by four monitoring rounds .
METHODS	We present results after 12 years of follow-up .
METHODS	Poisson regression method was used to calculate the rate ratios ( RRs ) ; two-sided ( 2 ) was used to calculate the probability .
RESULTS	We recruited 75360 women from 10 clusters in the screening group and 76178 women from 10 comparable clusters in the control group .
RESULTS	In the screening group , we achieved 89 % participation for screening and 79.4 % compliance for diagnosis confirmation .
RESULTS	The incidence of invasive cervical cancer was 26.74 per 100000 ( 95 % confidence interval [ CI ] = 23.41 to 30.74 ) in the screening group and 27.49 per 100000 ( 95 % CI = 23.66 to 32.09 ) in the control group .
RESULTS	Compliance to treatment for invasive cancer was 86.3 % in the screening group and 72.3 % in the control group .
RESULTS	The screening group showed a statistically significant 31 % reduction in cervical cancer mortality ( RR = 0.69 ; 95 % CI = 0.54 to 0.88 ; P = .003 ) .
CONCLUSIONS	VIA screening by primary health workers statistically significantly reduced cervical cancer mortality .
CONCLUSIONS	Our study demonstrates the efficacy of an easily implementable strategy that could prevent 22000 cervical cancer deaths in India and 72600 deaths in resource-poor countries annually .

###25646883
BACKGROUND	In a randomized controlled trial ( RCT ) in a blood bank in So Paulo , we tested the hypotheses that offering client-centered human immunodeficiency virus ( HIV ) counseling and testing to blood donors would : 1 ) reduce the risk of HIV contamination in the blood supply by diverting higher-risk , test-seeking donors away from donation and 2 ) increase return for results and referrals to care .
METHODS	We randomly selected weeks between August 2012 and May 2013 when donors were offered HIV counseling and testing ( n = 6298 ) , leaving usual procedure weeks as control ( n = 5569 ) .
RESULTS	Few candidate donors chose HIV testing ( n = 81 , 1.3 % ) .
RESULTS	There was no significant difference in herpes simplex virus Type 2 ( HSV-2 ) prevalence ( a marker of sexual risk ) among donors during intervention weeks compared to control ( 10.4 % vs. 11.1 % , p = 0.245 ) .
RESULTS	No donor choosing testing was HIV infected , and there was no difference in HSV-2 prevalence between testers and donors ( 9.9 % vs. 10.4 % , p = 0.887 ) .
RESULTS	Returning for positive results did not differ between testers and donors ( three of three vs. 58 of 80 , p = 0.386 ) .
RESULTS	A higher proportion of donors acknowledged that HIV testing was a strong motivation to donate during intervention weeks compared to control ( 2.6 % vs. 2.0 % , p = 0.032 ) .
CONCLUSIONS	The evidence of our RCT is that offering HIV counseling and testing at the time of donation would not change the risk of contamination in the blood supply , nor improve results disclosure and referral to care .

###24963110
OBJECTIVE	To evaluate the feasibility of day and night closed-loop insulin delivery in adults with type 1 diabetes under free-living conditions .
METHODS	Seventeen adults with type 1 diabetes on insulin pump therapy ( means SD age 34 9 years , HbA1c 7.6 0.8 % , and duration of diabetes 19 9 years ) participated in an open-label multinational three-center crossover study .
METHODS	In a random order , participants underwent two 8-day periods ( first day at the clinical research facility followed by 7 days at home ) of sensor-augmented insulin pump therapy ( SAP ) or automated closed-loop insulin delivery .
METHODS	The primary end point was the time when sensor glucose was in target range between 3.9 and 10.0 mmol/L during the 7-day home phase .
RESULTS	During the home phase , the percentage of time when glucose was in target range was significantly higher during closed-loop compared with SAP ( median 75 % [ interquartile range 61-79 ] vs. 62 % [ 53-70 ] , P = 0.005 ) .
RESULTS	Mean glucose ( 8.1 vs. 8.8 mmol/L , P = 0.027 ) and time spent above target ( P = 0.013 ) were lower during closed loop , while time spent below target was comparable ( P = 0.339 ) .
RESULTS	Increased time in target was observed during both daytime ( P = 0.017 ) and nighttime ( P = 0.013 ) .
CONCLUSIONS	Compared with SAP , 1 week of closed-loop insulin delivery at home reduces mean glucose and increases time in target without increasing the risk of hypoglycemia in adults with relatively well-controlled type 1 diabetes .

###24882549
BACKGROUND	Elevated homocysteine ( Hcy ) levels might play a role in the development of essential hypertension ( EH ) .
BACKGROUND	Telomere dynamics provide valuable insight into the pathogenesis of age-related diseases .
BACKGROUND	The contribution of Hcy to leukocyte telomere length ( LTL ) shortening in EH and the underlying mechanism was examined .
RESULTS	LTL ( ratio of the copy number of telomere [ T ] repeats to that of a single [ S ] gene , T/S ratio ) was inversely associated with age in patients with EH ( n = 258 ) and healthy controls ( n = 137 ) , but significantly decreased with the Hcy level only in patients with hypertension after adjustment for age and sex .
RESULTS	Age , hypertension and levels of Hcy and low-density lipoprotein combined contributed to LTL shortening ; an increased serum folate level could reverse the Hcy effect seen on multivariate regression analysis .
RESULTS	In addition , qPCR and methylation-specic PCR assay revealed that LTL shortening and mRNA expression and the methylation ratio of human telomerase reverse transcriptase ( hTERT ) were lower in patients with EH than in controls , and gradually decreased with increasing Hcy level , but not with blood pressure , in EH patients ( Ptrend < 0.0001 , 0.004 and 0.012 , respectively ) .
RESULTS	Furthermore , Hyperhomocysteinemia , but not hypertension , promoted telomerase reverse transcriptase DNA hypomethylation and reduced mRNA levels , which contributed to shortened LTL in the hypertension rat model .
CONCLUSIONS	Elevated Hcy but not hypertension was related to hTERT DNA hypomethylation and reduced mRNA level , thus contributing to the shortening of LTL hypertension .

###25541524
OBJECTIVE	This study aimed to evaluate differences in transcranial electrical motor evoked potential ( tcMEP ) amplitudes between desflurane/remifentanil and propofol/remifentanil anesthesia treatment plans in patients without preexisting motor deficits ( PMDs ) undergoing carotid endarterectomy ( CEA ) .
METHODS	This prospective trial included 21 patients who were randomly assigned to an effect group ( Group ( DESFLURANE ) ; n = 14 ) or a control group ( Group ( STANDARD-PROPOFOL ) ; n = 7 ) .
METHODS	tcMEP amplitudes were measured 35 min post-induction ( T1 ) either with desflurane or propofol .
METHODS	Treatment was then changed to propofol in Group ( DESFLURANE ) .
METHODS	After an additional 35 min , the tcMEP amplitudes were reevaluated ( T2 ) .
METHODS	Differences in amplitudes ( DW ) between T1 and T2 were calculated for each patient , and the means of these differences were compared between groups .
RESULTS	tcMEPs were recorded in all 21 patients .
RESULTS	At T1 , the mean amplitude was 840.1 ( SD 50.3 ) V and 358.9 ( SD 74 ) V for Group ( STANDARD-PROPOFOL ) and Group ( DESFLURANE ) , respectively .
RESULTS	The absolute mean difference ( T1-T2 ) between groups was -496.75 V ( p = 0.0006 ) .
CONCLUSIONS	Desflurane reduces the tcMEP amplitude significantly more than propofol in patients without PMDs undergoing CEA .
CONCLUSIONS	TcMEPs were recorded in all patients regardless of the anesthesia regimen .
CONCLUSIONS	In patients with initially small amplitudes , desflurane may limit tcMEP recording because it produces a remarkable amplitude reduction , even in patients without PMDs .

###25692915
BACKGROUND	The relative efficacy and safety of intravitreous aflibercept , bevacizumab , and ranibizumab in the treatment of diabetic macular edema are unknown .
METHODS	At 89 clinical sites , we randomly assigned 660 adults ( mean age , 6110 years ) with diabetic macular edema involving the macular center to receive intravitreous aflibercept at a dose of 2.0 mg ( 224 participants ) , bevacizumab at a dose of 1.25 mg ( 218 participants ) , or ranibizumab at a dose of 0.3 mg ( 218 participants ) .
METHODS	The study drugs were administered as often as every 4 weeks , according to a protocol-specified algorithm .
METHODS	The primary outcome was the mean change in visual acuity at 1 year .
RESULTS	From baseline to 1 year , the mean visual-acuity letter score ( range , 0 to 100 , with higher scores indicating better visual acuity ; a score of 85 is approximately 20/20 ) improved by 13.3 with aflibercept , by 9.7 with bevacizumab , and by 11.2 with ranibizumab .
RESULTS	Although the improvement was greater with aflibercept than with the other two drugs ( P < 0.001 for aflibercept vs. bevacizumab and P = 0.03 for aflibercept vs. ranibizumab ) , it was not clinically meaningful , because the difference was driven by the eyes with worse visual acuity at baseline ( P < 0.001 for interaction ) .
RESULTS	When the initial visual-acuity letter score was 78 to 69 ( equivalent to approximately 20/32 to 20/40 ) ( 51 % of participants ) , the mean improvement was 8.0 with aflibercept , 7.5 with bevacizumab , and 8.3 with ranibizumab ( P > 0.50 for each pairwise comparison ) .
RESULTS	When the initial letter score was less than 69 ( approximately 20/50 or worse ) , the mean improvement was 18.9 with aflibercept , 11.8 with bevacizumab , and 14.2 with ranibizumab ( P < 0.001 for aflibercept vs. bevacizumab , P = 0.003 for aflibercept vs. ranibizumab , and P = 0.21 for ranibizumab vs. bevacizumab ) .
RESULTS	There were no significant differences among the study groups in the rates of serious adverse events ( P = 0.40 ) , hospitalization ( P = 0.51 ) , death ( P = 0.72 ) , or major cardiovascular events ( P = 0.56 ) .
CONCLUSIONS	Intravitreous aflibercept , bevacizumab , or ranibizumab improved vision in eyes with center-involved diabetic macular edema , but the relative effect depended on baseline visual acuity .
CONCLUSIONS	When the initial visual-acuity loss was mild , there were no apparent differences , on average , among study groups .
CONCLUSIONS	At worse levels of initial visual acuity , aflibercept was more effective at improving vision .
CONCLUSIONS	( Funded by the National Institutes of Health ; ClinicalTrials.gov number , NCT01627249 . )

###25503265
BACKGROUND	Pre-exposure prophylaxis ( PrEP ) with daily oral emtricitabine ( FTC ) / tenofovir disoproxil fumarate may select for drug resistance if there is low adherence .
METHODS	Plasma viral HIV-1 RNA level , CD4 + T-cell counts , and drug resistance were evaluated among seroconverting women in the FEM-PrEP trial ( clinicaltrials.gov NCT00625404 ) using standard clinical tests , allele-specific PCR ( ASPCR ) , and by deep sequencing .
METHODS	Tenofovir , FTC , and their intracellular metabolites were measured in plasma and cells .
RESULTS	There was no difference in plasma HIV-1 RNA level or CD4 + cell count among seroconverters in the active arm versus those receiving placebo .
RESULTS	Tenofovir resistance was not observed .
RESULTS	FTC resistance was detected using clinical assays in five seroconverters ( four in the active arm and one in the placebo arm ) ; two in the active arm occurred among women having moderate concentrations of PrEP drugs in the blood .
RESULTS	The first evidence of infection occurred at the first postenrollment visit in three of the four with FTC resistance , although none had detectable viral nucleic acids at enrollment .
RESULTS	FTC-resistant minor variants were detected in an additional four seroconverters ( one in the active arm and three in the placebo arm ) .
CONCLUSIONS	Drug resistance detected during ineffective PrEP use had characteristics suggesting transmitted infection or incubating infection prior to starting PrEP .

###24317204
BACKGROUND	The authors sought to determine the level of inspiratory pressure minimizing the risk of gastric insufflation while providing adequate pulmonary ventilation .
BACKGROUND	The primary endpoint was the increase in incidence of gastric insufflation detected by ultrasonography of the antrum while inspiratory pressure for facemask pressure-controlled ventilation increased from 10 to 25 cm H2O .
METHODS	In this prospective , randomized , double-blind study , patients were allocated to one of the four groups ( P10 , P15 , P20 , and P25 ) defined by the inspiratory pressure applied during controlled-pressure ventilation : 10 , 15 , 20 , and 25 cm H2O .
METHODS	Anesthesia was induced using propofol and remifentanil ; no neuromuscular-blocking agent was administered .
METHODS	Once loss of eyelash reflex occurred , facemask ventilation was started for a 2-min period while gastric insufflation was detected by auscultation and by real-time ultrasonography of the antrum .
METHODS	The cross-sectional antral area was measured using ultrasonography before and after facemask ventilation .
METHODS	Respiratory parameters were recorded .
RESULTS	Sixty-seven patients were analyzed .
RESULTS	The authors registered statistically significant increases in incidences of gastric insufflation with inspiratory pressure , from 0 % ( group P10 ) to 41 % ( group P25 ) according to auscultation , and from 19 to 59 % according to ultrasonography .
RESULTS	In groups P20 and P25 , detection of gastric insufflation by ultrasonography was associated with a statistically significant increase in the antral area .
RESULTS	Lung ventilation was insufficient for group P10 .
CONCLUSIONS	Inspiratory pressure of 15 cm H2O allowed for reduced occurrence of gastric insufflation with proper lung ventilation during induction of anesthesia with remifentanil and propofol in nonparalyzed and nonobese patients .
CONCLUSIONS	( Anesthesiology 2014 ; 120:326 -34 ) .

###24743455
OBJECTIVE	Chronic lymphedema occurs frequently in breast cancer patients and is associated with significant morbidity and reduced quality-of-life .
OBJECTIVE	In this pilot study , the authors ( 1 ) addressed whether conducting a larger randomized controlled trial of aqua lymphatic therapy ( ALT ) would be feasible and ( 2 ) estimated the extent to which ALT combined with home-based exercise compared with home-based exercise alone would reduce arm disability in patients with breast cancer-related lymphedema .
METHODS	Twenty-five women with breast cancer-related lymphedema were randomized to either ALT in addition to a home land-based exercise program ( ALT group ; n = 13 ) or to a home land-based exercise program alone ( control group ; n = 12 ) .
METHODS	The participants were evaluated before and after a 12-wk intervention period composed of weekly pool exercise sessions .
METHODS	Main outcome measures were arm volume , arm disability , pain , and quality-of-life .
RESULTS	At follow-up , there was no statistical difference between the control and ALT groups in any of the outcomes , except for present pain intensity .
RESULTS	At the end of the study period , there was no change in the lymphedematous limb volume in either group .
RESULTS	Grip strength was improved in both groups .
RESULTS	Only the ALT group showed a statistically significant difference with a reduction in pain intensity score and arm disability .
RESULTS	Furthermore , quality-of-life significantly improved only in the ALT group .
CONCLUSIONS	Conducting a larger randomized controlled trial would be feasible .
CONCLUSIONS	In comparison with the beginning of the intervention , the participants in the ALT group showed significant beneficial changes after 12 wks of treatment , whereas the control group did not improve .
CONCLUSIONS	ALT did not make the lymphedema volume worse and therefore may serve as a safe alternative to land-based treatments of breast cancer-related lymphedema .

###25525601
OBJECTIVE	The aim of the study was to elicit the safety and efficacy of breast stimulation as an intervention to prevent postdatism and as an aid in spontaneous onset of labour .
METHODS	Primigravidas with cephalic presentation , without any high-risk factor , were recruited between 36 to 38 weeks of gestation .
METHODS	200 patients were recruited and randomized into two groups ( n = 100 ) .
METHODS	Breast stimulation was advised to one group but not to the other group .
METHODS	Bishop 's scoring was done at 38 weeks and repeated at 39 weeks of gestation .
METHODS	Maternal and fetal outcomes were compared in two groups .
RESULTS	Bishop 's score changed from 3.12 ( 1.01 ) to 3.9 ( 1.08 ) in control group and from 3.02 ( 0.82 ) to 6.08 ( 1.29 ) in breast stimulation group after one week ( P value < 0.0001 ) .
RESULTS	The period of gestation at delivery was 39.5 ( 2.3 ) weeks in control group and 39.2 ( 2.8 ) weeks in intervention group ( P value : 0.044 ) .
RESULTS	There were increased chances of vaginal delivery in intervention group ( P value : 0.046 ) .
RESULTS	Duration of labor , hyperstimulation , presence of meconium stained liquor , postpartum hemorrhage , and neonatal outcomes were similar in both groups .
CONCLUSIONS	Breast stimulation in low-risk primigravidas helps in cervical ripening and increases chances of vaginal delivery .

###25367835
OBJECTIVE	We examined whether an empirically based , randomised controlled trial of a preventive intervention for divorced mothers and children had a long-term impact on offspring cortisol regulation .
METHODS	Divorced mothers and children ( age 9-12 ) were randomly assigned to a literature control condition or the 11-week New Beginnings Program , a family-focused group preventive intervention for mothers and children in newly divorced families .
METHODS	Fifteen years after the trial , offspring salivary cortisol ( n = 161 ) was measured before and after a social stress task .
RESULTS	Multilevel mixed models were used to predict cortisol from internalizing symptoms , externalizing symptoms , group assignment and potential moderators of intervention effects .
RESULTS	Across the sample , higher externalizing symptoms were associated with lower cortisol reactivity .
RESULTS	There was a significant group-by-age interaction such that older offspring in the control group had higher reactivity relative to the intervention group , and younger offspring in the control group exhibited a decline across the task relative to younger offspring in the intervention group .
CONCLUSIONS	Preventive interventions for youth from divorced families may have a long-term impact on cortisol reactivity to stress .
CONCLUSIONS	Results highlight the importance of examining moderators of program effects .

###24613436
OBJECTIVE	The aim of this study was to compare the effect of administration of probiotics on feeding tolerance and growth outcomes of HIV-exposed ( but uninfected ) versus HIV non-exposed preterm infants .
OBJECTIVE	The null hypothesis of this study states that there will be no difference in the feeding tolerance and growth outcomes for both probiotic-exposed and unexposed premature very low birth weight infants .
METHODS	A randomized , double-blind , placebo-controlled trial was conducted during the period from July 2011 to August 2012 .
METHODS	HIV-exposed and non-exposed premature ( < 34 wk gestation ) infants with a birth weight of 500 g and 1250 g were randomized to receive either a probiotic mixture or placebo .
METHODS	The multispecies probiotic mixture consisted of 1 10 ( 9 ) CFU , Lactobacillus rhamnosus GG and Bifidobacterium infantis per day and was administered for 28 d. Anthropometrical parameters , daily intakes , and feeding tolerance were monitored .
RESULTS	Seventy-four HIV-exposed and 110 unexposed infants were enrolled and randomized ( mean birth weight 987 g 160 g , range , 560-1244 g ; mean gestational age 28.7 wk ) .
RESULTS	In all 4227 probiotic doses were administered ( mean 22.9 / infant ) .
RESULTS	There was no difference in the average daily weight gain for treatment groups or HIV exposure .
RESULTS	The HIV-exposed group achieved significantly higher z scores for length and head circumference at day 28 than the unexposed group ( P < 0.01 and P = 0.03 , respectively ) .
RESULTS	There were no differences in the incidence of any signs of feeding intolerance and abdominal distension between the groups .
CONCLUSIONS	Probiotic supplementation did not affect growth outcomes or the incidence of any signs of feeding intolerance in HIV exposure .

###25174321
OBJECTIVE	The use of evidence-based guidelines can improve the care for asthma patients .
OBJECTIVE	We implemented a computerized asthma management system in a pediatric emergency department ( ED ) to integrate national guidelines .
OBJECTIVE	Our objective was to determine whether patient eligibility identification by a probabilistic disease detection system ( Bayesian network ) combined with an asthma management system embedded in the workflow decreases time to disposition decision .
METHODS	We performed a prospective , randomized controlled trial in an urban , tertiary care pediatric ED .
METHODS	All patients 2-18 years of age presenting to the ED between October 2010 and February 2011 were screened for inclusion by the disease detection system .
METHODS	Patients identified to have an asthma exacerbation were randomized to intervention or control .
METHODS	For intervention patients , asthma management was computer-driven and workflow-integrated including computer-based asthma scoring in triage , and time-driven display of asthma-related reminders for re-scoring on the electronic patient status board combined with guideline-compliant order sets .
METHODS	Control patients received standard asthma management .
METHODS	The primary outcome measure was the time from triage to disposition decision .
RESULTS	The Bayesian network identified 1339 patients with asthma exacerbations , of which 788 had an asthma diagnosis determined by an ED physician-established reference standard ( positive predictive value 69.9 % ) .
RESULTS	The median time to disposition decision did not differ among the intervention ( 228 min ; IQR = ( 141 , 326 ) ) and control group ( 223 min ; IQR = ( 129 , 316 ) ) ; ( p = 0.362 ) .
RESULTS	The hospital admission rate was unchanged between intervention ( 25 % ) and control groups ( 26 % ) ; ( p = 0.867 ) .
RESULTS	ED length of stay did not differ among intervention ( 262 min ; IQR = ( 165 , 410 ) ) and control group ( 247 min ; IQR = ( 163 , 379 ) ) ; ( p = 0.818 ) .
CONCLUSIONS	The control and intervention groups were similar in regards to time to disposition ; the computerized management system did not add additional wait time .
CONCLUSIONS	The time to disposition decision did not change ; however the management system integrated several different information systems to support clinicians ' communication .

###25207513
OBJECTIVE	Understanding the characteristics of young adults who have difficulty achieving a healthy weight may help develop more effective interventions .
METHODS	Signal detection was conducted to identify subgroups of overweight/obese young adults more or less likely to lose weight ( 5 % weight loss ) over 6 months .
METHODS	Data were collected from a diverse sample involved in a randomized controlled behavioral weight loss intervention ( N = 404 ) .
RESULTS	Overall , 15 % ( N = 57 ) of participants achieved < 5 % weight loss .
RESULTS	Change in self-monitoring weight , baseline score of gym attendance/participating in exercise classes , and change in eating less fat were the best predictors of weight loss .
CONCLUSIONS	These strategies may be particularly helpful to promote short-term weight loss in overweight/obese young adults .

###24621122
OBJECTIVE	The Central Retinal Enrichment Supplementation Trials ( CREST ) aim to investigate the potential impact of macular pigment ( MP ) enrichment , following supplementation with a formulation containing 10mg lutein ( L ) , 2mg zeaxanthin ( Z ) and 10mg meso-zeaxanthin ( MZ ) , on visual function in normal subjects ( Trial 1 ) and in subjects with early age-related macular degeneration ( AMD ; Trial 2 ) .
METHODS	CREST is a single center , double-blind , randomized clinical trial .
METHODS	Trial 1 ( 12-month follow-up ) subjects are randomly assigned to a formulation containing 10mgL , 10mg MZ and 2mg Z ( n = 60 ) or placebo ( n = 60 ) .
METHODS	Trial 2 ( 24-month follow-up ) subjects are randomly assigned to a formulation containing 10mgL , 10mg MZ , 2mg Z plus 500mg vitamin C , 400IU vitamin E , 25mg zinc and 2mg copper ( Intervention A ; n = 75 ) or 10mgL and 2mg Z plus 500mg vitamin C , 400IU vitamin E , 25mg zinc and 2mg copper ( Intervention B ; n = 75 ) .
METHODS	Contrast sensitivity ( CS ) at 6 cycles per degree represents the primary outcome measure in each trial .
METHODS	Secondary outcomes include : CS at other spatial frequencies , MP , best-corrected visual acuity , glare disability , photostress recovery , light scatter , cognitive function , foveal architecture , serum carotenoid concentrations , and subjective visual function .
METHODS	For Trial 2 , AMD morphology , reading speed and reading acuity are also being recorded .
CONCLUSIONS	CREST is the first study to investigate the impact of supplementation with all three macular carotenoids in the context of a large , double-blind , randomized clinical trial .

###25642687
OBJECTIVE	This randomized double blind controlled study is aimed at determining the effect of repeated vibratory stimuli focally applied to the contracted quadriceps muscles ( repeated muscle vibration = rMV ) on bone mineral density , leg power and balance of postmenopausal osteoporotic women .
METHODS	The study has been conducted on 40 voluntary postmenopausal osteoporotic women , randomised at 2 groups for rMV treatment and for control .
METHODS	The treatment group underwent rMV ( 100Hz , 300-500 m ; three applications per day , each lasting 10-minutes , for 3 consecutive days ) applied to voluntary contracted quadriceps ( VC = vibrated and contracted group ) .
METHODS	The control group , received a sham stimulation on contracted quadriceps ( NV = non vibrated group ) .
METHODS	Bone mineral density T-score of proximal femur of the participants , was evaluated in two weeks before and 360 days after intervention ; body balance and explosive leg power were measured 1 day before , 30 days and 360 days after treatment .
RESULTS	VC group T-score at one year did n't change significantly relative to baseline values ( pretreatment : -2.610.11 , post-treatment -2.620.13 ) ; conversely in NV subjects T-score decreased significantly from -2.64 0.15 SD down to -2.99 0.28 SD .
RESULTS	A significant improvement of balance and explosive leg power was observed only in VC group at 30 and 360 days after the intervention .
CONCLUSIONS	We conclude that rMV is a safe , short-lasting and non-invasive treatment that can significantly and persistently improve muscle performance and can effectively counteract progressive demineralisation in postmenopausal and osteoporotic women .

###24661523
OBJECTIVE	To evaluate the efficacy of calf pulmonary surfactant ( PS ) in the treatment of respiratory distress syndrome ( RDS ) in late preterm and full-term infants .
METHODS	A randomized controlled trial was designed to evaluate the efficacy of calf PS intratracheally given at different times and doses in infants with RDS who had a gestational age of 35 weeks and an oxygenation index ( OI ) of 10-20 .
METHODS	The subjects were randomly assigned to treatment group 1 ( n = 58 ) , treatment group 2 ( n = 58 ) , and control group ( n = 59 ) .
METHODS	Treatment group 1 was given PS ( 50 mg/kg ) within 6 hours after admission .
METHODS	Treatment group 2 was given PS ( 70 mg/kg ) within 6 hours after admission .
METHODS	The control group was not given PS within 6 hours after admission and was given PS ( 50 mg/kg ) over 6 hours after admission if having no remission by conventional therapy including mechanical ventilation .
METHODS	For each group , a second dose of PS ( 50 mg/kg ) was given if no remission was observed within 12 hours after the first administration .
RESULTS	There were no significant differences in mortality between the three groups .
RESULTS	Treatment group 2 had lower hospitalization expense and shorter duration of mechanical ventilation compared with treatment group 1 , and treatment group 1 had lower hospitalization expense and shorter duration of mechanical ventilation compared with the control group .
RESULTS	The incidence of ventilator-associated pneumonia and length of hospital stay in treatment group 2 was lower than those in treatment group 1 and control group .
RESULTS	Compared with the control group , Treatment groups 1 and 2 showed decreases in 2 or more times of PS use , maximum OI , duration of continuous positive airway pressure treatment , and incidence of air leak syndrome and pulmonary hypertension .
CONCLUSIONS	Early use of sufficient PS in late preterm and full-term infants with RDS can reduce complications , secondary use of PS , duration of mechanical ventilation and length of hospital stay , and hospitalization expense .

###25425651
OBJECTIVE	To determine the association of arterial partial pressure of carbon dioxide PaCO2 with severe intraventricular haemorrhage ( sIVH ) , bronchopulmonary dysplasia ( BPD ) , and neurodevelopmental impairment ( NDI ) at 18-22months in premature infants .
METHODS	Secondary exploratory data analysis of Surfactant , Positive Pressure , and Oxygenation Randomised Trial ( SUPPORT ) .
METHODS	Multiple referral neonatal intensive care units .
METHODS	1316 infants 24 0/7 to 27 6/7 weeks gestation randomised to different oxygenation ( SpO2 target 85-89 % vs 91-95 % ) and ventilation strategies .
METHODS	Blood gases from postnatal day 0 to day14 were analysed .
METHODS	Five PaCO2 variables were defined : minimum ( Min ) , maximum ( Max ) , SD , average ( time-weighted ) , and a four level categorical variable ( hypercapnic ( highest quartile of Max PaCO2 ) , hypocapnic ( lowest quartile of Min PaCO2 ) , fluctuators ( hypercapnia and hypocapnia ) , and normocapnic ( middle two quartiles of Max and Min PaCO2 ) ) .
METHODS	PaCO2 variables were compared for infants with and without sIVH , BPD and NDI ( death ) .
METHODS	Multivariable logistic regression models were developed for adjusted results .
RESULTS	sIVH , BPD and NDI ( death ) were associated with hypercapnic infants and fluctuators .
RESULTS	Association of Max PaCO2 and outcomes persisted after adjustment ( per 10mmHg increase : sIVH/death : OR 1.27 ( 1.13 to 1.41 ) ; BPD/death : OR 1.27 ( 1.12 to 1.44 ) ; NDI/death : OR 1.23 ( 1.10 to 1.38 ) , death : OR 1.27 ( 1.12 to 1.44 ) , all p < 0.001 ) .
RESULTS	No interaction was found between PaCO2 category and SpO2 treatment group for sIVH/death , NDI/death or death .
RESULTS	Max PaCO2 was positively correlated with maximum FiO2 ( rs0 .55 , p < 0.0001 ) and ventilator days ( rs0 .61 , p < 0.0001 ) .
CONCLUSIONS	Higher PaCO2 was an independent predictor of sIVH/death , BPD/death and NDI/death .
CONCLUSIONS	Further trials are needed to evaluate optimal PaCO2 targets for high-risk infants .

###25363175
BACKGROUND	Peyronie 's disease described as penile curvature , fibromathosis and pain that occur most often in men aged 40 to 60 years .
BACKGROUND	The main complaint that caused the patient to visit the clinic is nodules on the upper surface of the penis , causing curvature and distortion particularly during erection , but they do n't have any urinary problem .
BACKGROUND	In this study , we evaluated the effect of verapamil compared to pentoxifylline in Peyronie 's disease .
METHODS	In this study , 90 patients with signs and symptoms of Peyronie 's disease which were diagnosed and were in the age range 40 to 70 years enrolled .
METHODS	The patients were randomly divided into 3 groups .
METHODS	First group received pentoxifylline orally at a dose of 400 mg three times a day , in the second group verapamil ( 10 mg every other week for up to 12 sessions ) was injected into the lesion and the third group received both treatments in combination .
RESULTS	In patients , who received pentoxifylline , curvature reduction was 26.7 % , plaque size reduction was 30 % , the recovery rate of erectile dysfunction was 46.7 % and pain reduced was 73.3 % .
RESULTS	Each of these cases in patients , who used beta-blockers , was 36.7 % , 33.3 % , 66.7 % and 76.6 % .
RESULTS	In combination therapy , curvature reduction was 36.7 % , plaque size reduction was 33.3 % , the recovery rate of erectile dysfunction was 86.7 % and pain reduced was 80 % .
CONCLUSIONS	In our study there was no significant difference between two groups using verapamil or pentoxifylline , but there was a significant improvement in combination therapy group .
CONCLUSIONS	Due to our results we propose that combination therapy can improve results and should be considered as a choice in treatment of Peyronie 's disease .

###25008857
BACKGROUND	Magnesium deficiency is associated with poor physical performance , but no trials are available on how magnesium supplementation affects elderly people 's physical performance .
OBJECTIVE	The aim of our study was to investigate whether 12 wk of oral magnesium supplementation can improve physical performance in healthy elderly women .
METHODS	In a parallel-group , randomized controlled trial , 139 healthy women ( mean SD age : 71.5 5.2 y ) attending a mild fitness program were randomly allocated to a treatment group ( 300 mg Mg/d ; n = 62 ) or a control group ( no placebo or intervention ; n = 77 ) by using a computer-generated randomization sequence , and researchers were blinded to their grouping .
METHODS	After assessment at baseline and again after 12 wk , the primary outcome was a change in the Short Physical Performance Battery ( SPPB ) ; secondary outcomes were changes in peak torque isometric and isokinetic strength of the lower limbs and handgrip strength .
RESULTS	A total of 124 participants allocated to the treatment ( n = 53 ) or control ( n = 71 ) group were considered in the final analysis .
RESULTS	At baseline , the SPPB scores did not differ between the 2 groups .
RESULTS	After 12 wk , the treated group had a significantly better total SPPB score ( = 0.41 0.24 points ; P = 0.03 ) , chair stand times ( = -1.31 0.33 s ; P < 0.0001 ) , and 4-m walking speeds ( = 0.14 0.03 m/s ; P = 0.006 ) than did the control group .
RESULTS	These findings were more evident in participants with a magnesium dietary intake lower than the Recommended Dietary Allowance .
RESULTS	No significant differences emerged for the secondary outcomes investigated , and no serious adverse effects were reported .
CONCLUSIONS	Daily magnesium oxide supplementation for 12 wk seems to improve physical performance in healthy elderly women .
CONCLUSIONS	These findings suggest a role for magnesium supplementation in preventing or delaying the age-related decline in physical performance .

###24807330
OBJECTIVE	To evaluate whether perioperative indomethacin and antibiotic administration at the time of examination-indicated cerclage placement prolongs gestation .
METHODS	This is a randomized controlled trial performed at a single tertiary care hospital between March 2010 and November 2012 .
METHODS	Women older than 18 years of age with a singleton pregnancy between 16 0/7 and 23 6/7 weeks of gestation undergoing an examination-indicated cerclage were eligible .
METHODS	Women were randomly assigned to receive either perioperative indomethacin and antibiotics or no perioperative prophylactic medications .
METHODS	The primary outcome was gestational latency after cerclage placement .
METHODS	Fifty women were required to be randomized to show , with 80 % power , a 28-day improvement in latency assuming a latency without intervention of 5035 days .
RESULTS	Fifty-three patients were enrolled with three lost to follow-up .
RESULTS	A greater proportion of pregnancies were prolonged by at least 28 days among women who received indomethacin and perioperative antibiotics ( 24 [ 92.3 % ] compared with 15 [ 62.5 % ] , P = .01 ) .
RESULTS	However , gestational age at delivery and neonatal outcomes were statistically similar between groups .
CONCLUSIONS	Among women receiving an examination-indicated cerclage in the second trimester , gestation was significantly more likely to be prolonged by 28 days among women who received perioperative indomethacin and antibiotics .
BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT01114516 .
METHODS	I.

###24283160
OBJECTIVE	The aim of this prospective randomized study was to evaluate a red clover based isoflavones supplementation in the treatment of climacteric syndrome and its effects on cardiovascular risk serum profile .
METHODS	The study included 150 healthy postmenopausal women that were randomly assigned to receive phytoestrogens tablets , amounting in a total daily intake of 60.8 mg red clover isoflavones plus 19.2 mg soy isoflavones ( n = 75 ) , or placebo ( n = 75 ) .
METHODS	The authors evaluated teh following : daily number of hot flushes and Kupperman Index at baseline and after one and three months ; serum total , high-density lipoprotein ( HDL ) and low-density lipoprotein ( LDL ) cholesterol , triglycerides , prothrombin time ( PT ) , partial thromboplastin time ( PTT ) , fibrinogen , and antithrombin III ( ATIII ) at baseline and after three and six months .
RESULTS	One hundred twenty-eight patients completed the study : 67 in the active group and 61 in the placebo group .
RESULTS	The treatment led to a progressive significant reduction ( p < 0.05 ) of the number of hot flushes in the active group compared to placebo already after one month , while Kupperman Index was statistically reduced after three months .
RESULTS	No significant variation in total cholesterol , LDL-cholesterol , HDL-cholesterol , triglycerides , PT , PTT , fibrinogen , and ATIII were found .
CONCLUSIONS	The present findings suggest that a red clover based isoflavones supplementation in healthy postmenopausal women is promptly effective on climacteric syndrome , improves neurovegetative symptoms , safe on cardiovascular risk serum profile , and does not modify lipids and coagulation .

###24842179
BACKGROUND	Myofascial pain syndrome is a regional condition of muscle pain and stiffness and is classically characterized by the presence of trigger points in affected musculature .
BACKGROUND	Botulinum toxin type A ( BoNT-A ) has been shown to have antinociceptive properties and elicit sustained muscle relaxation , thereby possibly affording even greater relief than traditional strategies .
BACKGROUND	Our goal was to determine whether direct injection of BoNT-A into painful muscle groups is effective for cervical and shoulder girdle myofascial pain .
METHODS	An enriched protocol design was used , wherein 114 patients with cervical and shoulder girdle myofascial pain underwent injection of BoNT-A to determine their response to the drug .
METHODS	Fifty-four responders were then enrolled in a 12-week , randomized , double-blind , placebo-controlled trial .
METHODS	Pain scales and quality of life measures were assessed at baseline and at routine follow-up visits until completion of the study after 26 weeks .
RESULTS	Injection of BoNT-A into painful muscle groups improved average visual numerical pain scores in subjects who received a second dose of BoNT-A compared to placebo ( P = 0.019 [ 0.26 , 2.78 ] ) .
RESULTS	Subjects who received a second dose of BoNT-A had a reduced number of headaches per week ( P = 0.04 [ 0.07 , 4.55 ] ) .
RESULTS	Brief Pain Inventory interference scores for general activity and sleep were improved ( P = 0.046 [ 0.038 , 3.700 ] and 0.02 [ 0.37 , 4.33 ] , respectively ) in those who received a second dose of BoNT-A .
CONCLUSIONS	BoNT-A injected directly into painful muscle groups improves average pain scores and certain aspects of quality of life in patients experiencing severe cervical and shoulder girdle myofascial pain .

###25042700
BACKGROUND	A prospective randomized trial was conducted to compare the impact of systemic chemotherapy versus multi-modality therapy ( complete cytoreductive surgery ( CRS ) , hyperthermic intraperitoneal chemotherapy ( HIPEC ) , and systemic chemotherapy ) on overall survival ( OS ) in patients with gastric carcinomatosis .
METHODS	Patients with measurable metastatic gastric adenocarcinoma involving the peritoneum , and resectable to `` no evidence of disease '' were randomized to gastrectomy , metastasectomy , HIPEC , and systemic FOLFOXIRI ( GYMS arm ) or FOLFOXIRI alone ( SA arm ) .
RESULTS	Seventeen patients were enrolled ( 16 evaluable ) ; 7 of 9 patients in the multi-modality GYMS arm achieved complete cytoreduction ( CCR0 ) .
RESULTS	Median OS was 11.3 months in the GYMS arm and 4.3 months in the SA arm .
RESULTS	Four patients in the GYMS arm survived > 12 months , 2 patients close to 2 years at last follow-up , and 1 patient more than 4 years , with 2 of these patients still alive .
RESULTS	No patient in the SA arm lived beyond 11 months .
RESULTS	All patients surviving beyond 12 months in the surgery arm achieved complete cytoreduction and had an initial Peritoneal Cancer Index ( PCI ) of 15 .
CONCLUSIONS	Maximal cytoreductive surgery combined with regional ( HIPEC ) and systemic chemotherapy in selected patients with gastric carcinomatosis and limited disease burden can achieve prolonged survival .

###25172198
OBJECTIVE	To report additional ocular outcomes of intensive treatment of hyperglycemia , blood pressure , and dyslipidemia in the Action to Control Cardiovascular Risk in Diabetes ( ACCORD ) study .
METHODS	Double 22 factorial , multicenter , randomized clinical trials in people with type 2 diabetes who had cardiovascular disease or cardiovascular risk factors .
METHODS	In the glycemia trial , targets of intensive and standard treatment were : hemoglobin A1c < 6.0 % and 7.0 % to 7.9 % , respectively , and in the blood pressure trial : systolic blood pressures of < 120 and < 140 mmHg , respectively .
METHODS	The dyslipidemia trial compared fenofibrate plus simvastatin with placebo plus simvastatin .
METHODS	Of the 3472 ACCORD Eye Study participants enrolled , 2856 had 4-year data ( 85 % of survivors ) .
METHODS	Eye examinations and fundus photographs were taken at baseline and year 4 .
METHODS	Photographs were graded centrally for retinopathy severity and macular edema using the Early Treatment Diabetic Retinopathy Study ( ETDRS ) methods .
METHODS	Three or more steps of progression on the ETDRS person scale or treatment of retinopathy with photocoagulation or vitrectomy .
RESULTS	As previously reported , there were significant reductions in the primary outcome in the glycemia and dyslipidemia trials , but no significant effect in the blood pressure trial .
RESULTS	Results were similar for retinopathy progression by 1 , 2 , and 4 or more steps on the person scale and for 2 steps on the eye scale .
RESULTS	In the subgroup of patients with mild retinopathy at baseline , effect estimates were large ( odds ratios , 0.30 ; P < 0.001 ) , but did not reach nominal significance for participants with no retinopathy or for those with moderate to severe retinopathy at baseline .
CONCLUSIONS	Slowing of progression of retinopathy by intensive treatment of glycemia was observed in ACCORD participants , whose average age and diabetes duration were 62 and 10 years , respectively , and who had cardiovascular disease or cardiovascular risk factors .
CONCLUSIONS	The effect seemed stronger in patients with mild retinopathy .
CONCLUSIONS	Similar slowing of progression was observed in patients treated with fenofibrate , with no effect observed with intensive blood pressure treatment .
CONCLUSIONS	This is the second study to confirm the benefits of fenofibrate in reducing diabetic retinopathy progression , and fenofibrate should be considered for treatment of diabetic retinopathy .

###25885780
BACKGROUND	Cooking over open fires using solid fuels is both common practice throughout much of the world and widely recognized to contribute to human health , environmental , and social problems .
BACKGROUND	The public health burden of household air pollution includes an estimated four million premature deaths each year .
BACKGROUND	To be effective and generate useful insight into potential solutions , cookstove intervention studies must select cooking technologies that are appropriate for local socioeconomic conditions and cooking culture , and include interdisciplinary measurement strategies along a continuum of outcomes .
METHODS	REACCTING ( Research on Emissions , Air quality , Climate , and Cooking Technologies in Northern Ghana ) is an ongoing interdisciplinary randomized cookstove intervention study in the Kassena-Nankana District of Northern Ghana .
METHODS	The study tests two types of biomass burning stoves that have the potential to meet local cooking needs and represent different `` rungs '' in the cookstove technology ladder : a locally-made low-tech rocket stove and the imported , highly efficient Philips gasifier stove .
METHODS	Intervention households were randomized into four different groups , three of which received different combinations of two improved stoves , while the fourth group serves as a control for the duration of the study .
METHODS	Diverse measurements assess different points along the causal chain linking the intervention to final outcomes of interest .
METHODS	We assess stove use and cooking behavior , cooking emissions , household air pollution and personal exposure , health burden , and local to regional air quality .
METHODS	Integrated analysis and modeling will tackle a range of interdisciplinary science questions , including examining ambient exposures among the regional population , assessing how those exposures might change with different technologies and behaviors , and estimating the comparative impact of local behavior and technological changes versus regional climate variability and change on local air quality and health outcomes .
CONCLUSIONS	REACCTING is well-poised to generate useful data on the impact of a cookstove intervention on a wide range of outcomes .
CONCLUSIONS	By comparing different technologies side by side and employing an interdisciplinary approach to study this issue from multiple perspectives , this study may help to inform future efforts to improve health and quality of life for populations currently relying on open fires for their cooking needs .

###24503927
BACKGROUND	The mean follow-up in the clinical trials of antiplatelet drugs in the secondary prevention of ischemic atherothrombotic stroke ranges from 1 to 5.5 years .
BACKGROUND	Thus , the safety and efficacy of these drugs in the very long term is not totally documented .
BACKGROUND	We have assessed the safety and effectiveness of triflusal and aspirin for a very long-term period in the secondary prevention of patients with ischemic atherothrombotic stroke .
METHODS	Patients with atherothrombotic ischemic stroke , including TIA , who participated in randomized clinical trials of triflusal versus aspirin were included in the study .
METHODS	The period of recruitment was between 1983 and 1999 .
METHODS	After finishing their participation in the clinical trials , patients were followed up in the Neurology Department of our hospital .
METHODS	All patients were treated with aspirin or triflusal during a mean period of 17.2 years .
METHODS	Groups were comparable with respect to sex , age , risk factor and etiology of the stroke .
METHODS	Adverse events and vascular events ( including stroke recurrence , ischemic heart disease and vascular death ) that appeared throughout the study were registered .
METHODS	Statistical analysis was performed using the statistical package SPSS 15.0 for Windows .
METHODS	Kaplan-Meier curves and the log-rank test were used to compare treatments .
RESULTS	A total of 441 patients ( 305 men ) with a mean age ( SD ) of 51.112.4 years were included in the study ; 288 patients ( 65.3 % ) were treated with triflusal and 153 with aspirin .
RESULTS	There were no statistically significant differences between aspirin and triflusal concerning new vascular events ( 72.5 vs. 60.4 % ; p = 0.28 ) , stroke recurrence ( 49.7 vs. 46.5 % ; p = 0.53 ) , ischemic heart events ( 54.9 vs. 55.6 % ; p = 0.90 ) , vascular death ( 25.5 vs. 24 % ; p = 0.73 ) and global mortality ( 42.5 vs. 42 % ; p = 0.92 ) .
RESULTS	The incidence of serious bleeding ( upper digestive tract hemorrhage and cerebral hemorrhage ) was 18.3 % in aspirin-treated patients and 5.5 % in triflusal-treated patients ( p < 0.001 ) .
RESULTS	In reference to other adverse events , no significant differences were found between aspirin and triflusal .
CONCLUSIONS	In the secondary prevention of ischemic stroke , very long-term treatment with triflusal or aspirin seems to have a similar efficacy , but triflusal is safer with a lower hemorrhagic risk .
CONCLUSIONS	Triflusal may be an alternative therapy , particularly in patients who present aspirin resistance .

###25881037
BACKGROUND	Low caste adolescent girls living in rural northern Karnataka are at increased risk of school drop-out , child marriage , and entry into sex-work , which enhances their vulnerability to HIV , early pregnancy and adverse maternal and child health outcomes .
BACKGROUND	This protocol describes the evaluation of Samata , a comprehensive , multi-level intervention designed to address these structural drivers of HIV risk and vulnerability .
METHODS	The Samata study is a cluster randomised controlled trial that will be conducted in eighty village clusters ( 40 intervention ; 40 control ) in Bijapur and Bagalkot districts in northern Karnataka .
METHODS	The intervention seeks to reach low caste girls and their families ; adolescent boys ; village communities ; high school teachers and school governing committees ; and local government officials .
METHODS	All low caste ( scheduled caste/tribe ) adolescent girls attending 7th standard ( final year of primary school ) will be recruited into the study in two consecutive waves , one year apart .
METHODS	Girls ( n = 2100 ) , their families ( n = 2100 ) and school teachers ( n = 650 ) will be interviewed at baseline and at endline .
METHODS	The study is designed to assess the impact of the intervention on four primary outcomes : the proportion of low caste girls who ( i ) enter into secondary school ; ( ii ) complete secondary school ; ( iii ) marry before age 15 ; and ( iv ) engage in sex before age 15 .
METHODS	Observers assessing the outcomes will be blinded to group assignment .
METHODS	The primary outcome will be an adjusted , cluster-level intention to treat analysis , comparing outcomes in intervention and control villages at follow-up .
METHODS	We will also conduct survival analyses for the following secondary outcomes : marriage , sexual debut , pregnancy and entry into sex work .
METHODS	Complementary monitoring and evaluation , qualitative and economic research will be used to explore and describe intervention implementation , the pathways through which change occurs , and the cost-effectiveness of the intervention .
CONCLUSIONS	This is an innovative trial of a comprehensive intervention to improve the quality of life and reduce HIV vulnerability among marginalised girls in northern Karnataka .
CONCLUSIONS	The findings will be of interest to programme implementers , policy makers and evaluation researchers working in the development , education , and sexual and reproductive health fields .
BACKGROUND	ClinicalTrials.Gov NCT01996241 .
BACKGROUND	16th November 2013 .

###25261884
BACKGROUND	Individuals with serious mental illness have high rates of obesity and a need for specialized weight loss intervention programs .
BACKGROUND	This study examines the efficacy of the RENEW weight loss intervention and examines the impact of the intervention setting on outcomes .
METHODS	136 individuals with serious mental illness from 4 different settings were randomly assigned to receive the RENEW weight loss intervention or a control condition of treatment as usual .
METHODS	The RENEW intervention is a one year program that includes an intensive , maintenance and intermittent supports phase .
RESULTS	The intervention group experienced a modest weight loss of 4.8 lbs at 3 months , 4.1 lbs at 6 months and a slight weight gain of 1.5 lbs at 12 months .
RESULTS	The control group gained a total of 6.2 lbs at 12 months .
RESULTS	However when settings were examined separately the responder sites had a weight loss of 9.4 lbs at 3 months , 10.9 lbs at 6 months and 7 lbs at 12 months .
CONCLUSIONS	These results suggest that the settings in which individuals receive services may act as a support or hindrance toward response to weight loss interventions .
CONCLUSIONS	The concept of the obesogenic environment deserves further examination as a factor in the success of weight loss programs .

###24617242
OBJECTIVE	To observe the impacts of different frequencies of electroacupuncture ( EA ) on post-operative cognitive function and the change in serum S-100beta protein under the compound anesthesia of acupuncture and drugs .
METHODS	One hundred and twenty-four patients of abdominal operation at selective time were randomized into a routine drug anesthesia group ( group A , 24 cases ) , a meridian point 2 Hz group ( group B , 26 cases ) , a me ridian point 2 Hz/100 Hz group ( group C , 25 cases ) , a meridian point 100 Hz group ( group D , 24 cases ) and a transcutaneous acupoint electric stimulation 2 Hz/100 Hz group ( group E , 25 cases ) .
METHODS	In group A , the endotrachea-lgeneral anesthesia was applied .
METHODS	In the rest groups , the acupuncture anesthesia was induced for 30 min before the endotracheal general anesthesia , at Baihui ( GV 20 ) , Yintang ( GV 29 ) and Neiguan ( PC 6 ) , with G6805-2 electric acupuncture apparatus used .
METHODS	In group B , the continuous wave and 2Hz in frequency were selected .
METHODS	In group C , the disperse-dense wave and 2 Hz/100 Hz in frequency were selected .
METHODS	In group D , the continuous wave and 100 Hz in frequency were selected .
METHODS	In group E , the disperse-dense wave and 2 Hz/100 Hz in frequency were selected , and the electrode pads were stick on the acupoints and connected with the electric stimulation till the end of operation .
METHODS	Mini-mental state examination ( MMSE ) was adopted to evaluate and record the changes in cognitive function 1 day before operation and on the 3rd day after operation .
METHODS	The conditions of post-operative cognitive dysfunction ( POCD ) in the patients and the changes in serum S-100beta protein were monitored before and at the end of operation .
RESULTS	The incidence rate of POCD on the 3rd day after operation was 41.7 % ( 10/24 ) in group A.
RESULTS	The incidence rates of POCD were 26.9 % ( 7/26 ) , 16.0 % ( 4/25 ) , 33.3 % ( 8/24 ) and 16.0 % ( 4/25 ) in group B , C , D and E separately .
RESULTS	Compared with group A , the incidence rate of PCOD in group B , C , D and E were reduced ( all P < 0.05 ) , the incidence rate in group C and E were lower than that in groups B and D ( all P < 0.05 ) .
RESULTS	At the end of operation , the level of serumS-100beta protein was ( 0.186 + / - 0.027 ) microg/L in group A , the levels were ( 0.165 + / - 0.028 ) microg/L , ( 0.166 + / - 0.027 ) microg/L , ( 0.163 + / - 0.025 ) microg/L and ( 0.164 + / - 0.025 ) microg/L in group B , C , D and E separately .
RESULTS	The levels of serum S-100beta protein in group B , C , D and E were lower than that in group A separately ( all P < 0.05 ) .
CONCLUSIONS	The general anesthesia assisted with EA at different frequencies reduces the incidence of cognitive dysfunctionand , decreases the level of serum S-100beta protein after intestinal cancer resection .
CONCLUSIONS	The effects of the meridian point electric stimulation at 2 Hz/100 Hz and the transcutaneous electric stimulation at 2 Hz/100 Hz are the best .
CONCLUSIONS	Hence , these two approaches of anesthesia deserve to be recommended practically .

###25141831
OBJECTIVE	Many features can influence the choice of a supraglottic airway device ( SAD ) , including ease of insertion , adequate ventilation pressures and lack of adverse effects .
OBJECTIVE	The goal of this randomized prospective trial was to compare the performance of the i-gel with that of the LMA-Supreme .
METHODS	One hundred adult patients ( American Society of Anesthesiologists I-III ) scheduled to undergo elective surgery under general anesthesia were randomized to either an i-gel ( n = 50 ) or an LMA-Supreme ( n = 50 ) .
METHODS	The primary objective was to compare ventilation pressures .
METHODS	Secondary objectives included time and number of attempts needed to introduce the device , adverse effects , and repositioning .
METHODS	The endoscopic view of the glottic aperture and the position of the drain tubes in relation to the esophagus were also evaluated .
RESULTS	The devices were inserted successfully in 46 ( 92 % ) patients in both groups .
RESULTS	There was no significant difference in the [ mean ( SD ) ] leak pressure [ i-gel : 23 ( 7 ) cm H2O vs LMA-Supreme : 21 ( 8 ) cm H2O ; P = 0.14 ] or peak inspiratory pressure between both devices .
RESULTS	Insertion time was shorter with the i-gel than with the LMA-Supreme [ 19 ( 7 ) sec vs 27 ( 17 ) sec , respectively ; P = 0.003 ] .
RESULTS	The vocal cords were completely visualized more often through the i-gel ( 70 % ) than through the LMA-Supreme ( 50 % ) ( P = 0.007 ) .
RESULTS	Esophageal mucosa was easily visualized through the drain port in all but four patients , two patients in each group .
RESULTS	There was no difference between groups regarding preoperative or postoperative complications .
RESULTS	Postoperative patient discomfort was generally mild and comparable between both devices .
CONCLUSIONS	Both the LMA-Supreme and the i-gel offer similar performance for positive pressure ventilation in paralyzed patients during general anesthesia .
CONCLUSIONS	The i-gel was associated with a slightly faster insertion time and better fibrescopic visualization of the glottis .
CONCLUSIONS	This trial was registered at Clinicaltrials.gov : NCT01001078 .

###25596096
OBJECTIVE	To test the efficacy of probiotic and prebiotic , alone or combined ( synbiotic ) , on the prevention of necrotizing enterocolitis ( NEC ) in very low birth weight ( VLBW ) infants .
METHODS	A prospective , randomized , controlled trial was conducted at 5 neonatal intensive care units in Turkey .
METHODS	VLBW infants ( n = 400 ) were assigned to a control group and 3 study groups that were given probiotic ( Bifidobacterium lactis ) , prebiotic ( inulin ) , or synbiotic ( Bifidobacterium lactis plus inulin ) added to breastmilk or formula for a maximum of 8 weeks before discharge or death .
METHODS	The primary outcome was NEC ( Bell stage 2 ) .
RESULTS	The rate of NEC was lower in probiotic ( 2.0 % ) and synbiotic ( 4.0 % ) groups compared with prebiotic ( 12.0 % ) and placebo ( 18.0 % ) groups ( P < .001 ) .
RESULTS	The times to reach full enteral feeding were faster ( P < .001 ) , the rates of clinical nosocomial sepsis were lower ( P = .004 ) , stays in the neonatal intensive care unit were shorter , ( P = .002 ) , and mortality rates were lower ( P = .003 ) for infants receiving probiotics , prebiotics , or synbiotic than controls .
RESULTS	The use of antenatal steroid ( OR 0.5 , 95 % CI 0.3-0 .9 ) and postnatal probiotic ( alone or in synbiotic ) ( OR 0.5 , 95 % CI 0.2-0 .8 ) decreased the risk of NEC , and maternal antibiotic exposure increased this risk ( OR 1.9 , 95 % CI 1.1-3 .6 ) .
CONCLUSIONS	In VLBW infants , probiotic ( Bifidobacterium lactis ) and synbiotic ( Bifidobacterium lactis plus inulin ) but not prebiotic ( inulin ) alone decrease NEC .

###25646809
OBJECTIVE	To examine whether behavioural strategies designed to improve children 's sleep problems could also improve the symptoms , behaviour , daily functioning , and working memory of children with attention deficit hyperactivity disorder ( ADHD ) and the mental health of their parents .
METHODS	Randomised controlled trial .
METHODS	21 general paediatric practices in Victoria , Australia .
METHODS	244 children aged 5-12 years with ADHD attending the practices between 2010 and 2012 .
METHODS	Sleep hygiene practices and standardised behavioural strategies delivered by trained psychologists or trainee paediatricians during two fortnightly consultations and a follow-up telephone call .
METHODS	Children in the control group received usual clinical care .
METHODS	At three and six months after randomisation : severity of ADHD symptoms ( parent and teacher ADHD rating scale IV-primary outcome ) , sleep problems ( parent reported severity , children 's sleep habits questionnaire , actigraphy ) , behaviour ( strengths and difficulties questionnaire ) , quality of life ( pediatric quality of life inventory 4.0 ) , daily functioning ( daily parent rating of evening and morning behavior ) , working memory ( working memory test battery for children , six months only ) , and parent mental health ( depression anxiety stress scales ) .
RESULTS	Intervention compared with control families reported a greater decrease in ADHD symptoms at three and six months ( adjusted mean difference for change in symptom severity -2.9 , 95 % confidence interval -5.5 to -0.3 , P = 0.03 , effect size -0.3 , and -3.7 , -6.1 to -1.2 , P = 0.004 , effect size -0.4 , respectively ) .
RESULTS	Compared with control children , intervention children had fewer moderate-severe sleep problems at three months ( 56 % v 30 % ; adjusted odds ratio 0.30 , 95 % confidence interval 0.16 to 0.59 ; P < 0.001 ) and six months ( 46 % v 34 % ; 0.58 , 0.32 to 1.0 ; P = 0.07 ) .
RESULTS	At three months this equated to a reduction in absolute risk of 25.7 % ( 95 % confidence interval 14.1 % to 37.3 % ) and an estimated number needed to treat of 3.9 .
RESULTS	At six months the number needed to treat was 7.8 .
RESULTS	Approximately a half to one third of the beneficial effect of the intervention on ADHD symptoms was mediated through improved sleep , at three and six months , respectively .
RESULTS	Intervention families reported greater improvements in all other child and family outcomes except parental mental health .
RESULTS	Teachers reported improved behaviour of the children at three and six months .
RESULTS	Working memory ( backwards digit recall ) was higher in the intervention children compared with control children at six months .
RESULTS	Daily sleep duration measured by actigraphy tended to be higher in the intervention children at three months ( mean difference 10.9 minutes , 95 % confidence interval -19.0 to 40.8 minutes , effect size 0.2 ) and six months ( 9.9 minutes , -16.3 to 36.1 minutes , effect size 0.3 ) ; however , this measure was only completed by a subset of children ( n = 54 at three months and n = 37 at six months ) .
CONCLUSIONS	A brief behavioural sleep intervention modestly improves the severity of ADHD symptoms in a community sample of children with ADHD , most of whom were taking stimulant medications .
CONCLUSIONS	The intervention also improved the children 's sleep , behaviour , quality of life , and functioning , with most benefits sustained to six months post-intervention .
CONCLUSIONS	The intervention may be suitable for use in primary and secondary care.Trial registration Current Controlled Trials ISRCTN68819261 .

###24308310
BACKGROUND	The physical and mental health of college students tends to continuously decline around the world .
BACKGROUND	Since they are in a significant transition period which presents opportunities and challenges in health promotion , it is important to improve their health in this period .
BACKGROUND	As a traditional Chinese exercise form which combines movements with breath and mind , Baduanjin may be one of the selectable effective exercises .
BACKGROUND	However , evidence of Baduanjin exercise for college students has not been completely established .
BACKGROUND	The primary aim of this trial is to evaluate the effectiveness and safety of Baduanjin exercise for physical and mental health of college students through a rigorous randomization , parallel-controlled design .
METHODS	We will conduct a randomized , single-blind , parallel-controlled trial .
METHODS	A total of 222 college students from Fujian University of Traditional Chinese Medicine who meet the eligibility criteria will be recruited and randomly allocated into Baduanjin training or usual exercise control group .
METHODS	Baduanjin training will last 12 weeks ( 1 h per day , 5 days per week ) .
METHODS	The physical and psychological outcomes , including lumbar muscle strength , lumbar proprioception function , physical fitness , as well as self-reported symptom intensity , stress , self-esteem , mood , quality of life , quality of sleep , and adverse events , will be evaluated by blinded outcome assessors at baseline , 13 weeks ( at the end of intervention ) , and 25 weeks ( after the 12-week follow-up period ) .
CONCLUSIONS	This protocol presents an objective design of a randomized , single-blind trial that aims to evaluate the effectiveness and safety of Baduanjin exercise for physical and mental health of college students .
CONCLUSIONS	If the outcome is positive , the results will provide higher-quality evidence to better inform the college students regarding their selection about whether to receive such exercise .
BACKGROUND	Chinese Clinical Trial Registry : ChiCTR-TRC-13003329 .
BACKGROUND	Registration date : 18 July , 2013 .

###25156227
BACKGROUND	Methamphetamine use has been previously associated with poor medication adherence , but , to date , there have been no studies that have conducted event-level analyses on correlates of medication adherence in studies of pharmacologic agents for methamphetamine dependence .
METHODS	We pooled data from two previous , randomized controlled trials ( using bupropion and mirtazapine , respectively ) for methamphetamine dependence and used a mixed effects logistic model to examine correlates of daily opening of the medication event monitoring system ( MEMS ) cap as a repeated measure .
METHODS	We explored whether periods of observed methamphetamine use via urine testing were associated with study medication adherence based on MEMS cap openings .
RESULTS	We found a significant negative association between methamphetamine-urine positivity and event-level study medication adherence as measured by MEMS cap openings ( AOR : 0.69 ; 95 % CI : 0.49-0 .98 ) .
RESULTS	In addition , age ( AOR : 1.07 ; 95 % CI : 1.02-1 .11 ) and depressive symptoms ( AOR : 0.78 ; 95 % CI : 0.64-0 .90 ) were significantly associated with adherence .
RESULTS	Finally , participants were more likely to open their study medication bottles on days when they presented for in-person urine testing .
CONCLUSIONS	Our event-level analysis shows that methamphetamine use can be associated with reduced medication adherence as measured by MEMS cap openings in pharmacologic trials , which corroborates prior research .
CONCLUSIONS	These findings may suggest that medication adherence support in pharmacologic trials among methamphetamine users may be needed to improve study compliance and could be targeted towards periods of time when there are more likely to not open their study medication pill bottles .

###25292137
BACKGROUND	Chronic venous disease is a group of symptoms caused by functional and structural defects of the venous vessels .
BACKGROUND	One of the most common aspects of this disease is the occurrence of varicose veins .
BACKGROUND	There are many ways of prevention and treatment of varicose veins , but in Poland the leading one is still surgery .
BACKGROUND	As in every medical procedure there is the possibility of some complications .
BACKGROUND	One of them is deep vein thrombosis ( DVT ) .
BACKGROUND	The diagnosis of DVT can be difficult , especially when access to a specialist is limited , such as in case of rural patients .
BACKGROUND	The aim of the study .
BACKGROUND	The aim of the study was estimation of the influence of LMWH primary prophylaxis on the formation of postoperative DVT , as well as sensitivity and specificity of clinical examination and D-dimer value in diagnosis of postoperative DVT in women .
METHODS	The study was conducted in a group of 93 women operated on in the Department of General , Vascular Surgery and Angiology at the Karol Marcinkowski University of Medical Sciences in Pozna , Poland .
METHODS	The patients had undergone a varicose vein operation and were randomly divided into two groups : A - 48 women receiving LMWH during two days of the perioperative period , B - 45 women receiving LMWH during seven days of the perioperative period .
RESULTS	There was no significant difference in the postoperative DVT complications in both groups .
RESULTS	The value of D-dimer > 0.987 mcg/ml and swelling > 1.5 cm of shin ( in comparison to the preoperative period ) plays a significant role in diagnosis of DVT .
CONCLUSIONS	The extended primary prophylaxis with LMWH does not affect the amount or quality of thrombotic complications after varicose vein operation .
CONCLUSIONS	If the DVT occurs , the evaluation of the D - dimer and careful clinical examination can be a useful method for its diagnosis .

###25494967
BACKGROUND	Preliminary studies have shown that rituximab ( RTX ) is effective in the treatment of active Graves ' orbitopathy ( GO ) .
METHODS	We conducted a double-blind , randomized trial ( European Clinical Trials Database [ EudraCT ] 2007-003910-33 ) to compare RTX with iv methylprednisolone ( ivMP ) in patients with active moderate to severe GO .
METHODS	Thirty-two patients were randomized to receive either ivMP ( 7.5 g ) or RTX ( 2000 or 500 mg ) .
METHODS	The primary end point was the decrease of the clinical activity score of 2 points or to less than 3 at week 24 .
METHODS	Changes of proptosis , lid fissure , diplopia and eye muscle motility , and quality of life score were secondary end points .
METHODS	The number of therapeutic responses , disease reactivation , and surgical procedures required during follow-up and the patients ' quality of life were also assessed .
RESULTS	The clinical activity score decreased with both treatments but more after RTX at 16 , 20 , and 24 weeks ( P < .04 , P < .02 , P < .006 , respectively ) , whether 1000 mg RTX twice or 500 mg RTX once was used ( P = NS ) .
RESULTS	At 24 weeks 100 % of RTX patients improved compared with 69 % after ivMP ( P < .001 ) .
RESULTS	Disease reactivation was never observed in RTX patients but was observed in five after ivMP .
RESULTS	Patients treated with RTX scored better motility at 52 weeks in both the right ( P = .014 ) and the left eye ( P = .026 ) .
RESULTS	Overall rehabilitative surgical procedures carried out during follow-up ( at 76 wk ) were 12 in 16 ivMP patients and 5 in 15 RTX patients ( P = .049 ) .
CONCLUSIONS	The results of this trial confirm preliminary reports on a better therapeutic outcome of RTX in active moderate to severe GO , when compared with ivMP , even after a lower RTX dose .
CONCLUSIONS	The better eye motility outcome , visual functioning of the quality of life assessment , and the reduced number of surgical procedures in patients after RTX seem to suggest a disease-modifying effect of the drug .

###24401555
BACKGROUND	Web-based brief alcohol interventions are effective in reducing alcohol use among students when measured at limited follow-up time points .
BACKGROUND	To date , no studies have tested Web-based brief alcohol intervention effectiveness over time by using a large number of measurements .
OBJECTIVE	Testing whether the What Do You Drink ( WDYD ) Web-based brief alcohol intervention can sustain a reduction in alcohol use among heavy-drinking students aged 18-24 years at 1 - , 3 - , and 6-month follow-up intervals .
METHODS	A purely Web-based , 2-arm , parallel-group randomized controlled trial applying an ecological momentary assessment approach with 30 weekly measurements was conducted in the Netherlands ( 2010-2011 ) .
METHODS	Participants were recruited offline and online .
METHODS	A total of 907 participants were randomized into the experimental condition ( n = 456 ) including the single-session and fully automated WDYD intervention , or into the control condition ( n = 451 ) including assessment only .
METHODS	Weekly alcohol consumption and frequency of binge drinking were the self-assessed outcome measures .
RESULTS	Attrition rates of the 907 participants were 110 ( 12.1 % ) , 130 ( 14.3 % ) , and 162 ( 17.9 % ) at 1 - , 3 - , and 6-month follow-up intervals , respectively .
RESULTS	Latent growth curve analyses according to the intention-to-treat principle revealed that participants in the experimental condition had significantly lower weekly alcohol consumption compared to participants in the control condition that was sustained at 3-month follow-up ( intercept = -2.60 , P < .001 ; slope = 0.16 , P = .08 ) .
RESULTS	Additional linear regression analyses indicated that this intercept difference resulted from significantly higher levels of alcohol units per week for participants in the control condition compared to those in the experimental condition at 1-month ( beta = -2.56 , SE 0.74 , Cohen 's d = 0.20 , P = .001 ) , 3-month ( beta = -1.76 , SE 0.60 , Cohen 's d = 0.13 , P = .003 ) , and 6-month ( beta = -1.21 , SE 0.58 , Cohen 's d = 0.09 , P = .04 ) follow-up intervals .
RESULTS	Latent growth curve analyses further indicated that participants in the experimental condition had a significantly lower frequency of binge drinking compared to participants in the control condition that was sustained at 6-month follow-up ( intercept = -0.14 , P = .01 ; slope = 0.004 , P = .19 ) .
RESULTS	This intercept difference resulted from higher levels in this outcome for participants in the control condition relative to participants in the experimental condition at 1-month ( beta = -1.15 , SE 0.06 , Cohen 's d = 0.16 , P = .01 ) , 3-month ( beta = -0.12 , SE 0.05 , Cohen 's d = 0.09 , P = .01 ) , and 6-month ( beta = -0.09 , SE 0.05 , Cohen 's d = 0.03 , P = .045 ) follow-up intervals .
CONCLUSIONS	The WDYD intervention was shown to be effective in preventing an increase in weekly alcohol consumption and frequency of binge drinking directly after the intervention .
CONCLUSIONS	This effect was sustained 3 and 6 months after the intervention .
BACKGROUND	Netherlands Trial Register NTR2665 ; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2665 ( Archived by WebCite at http://webcitation.org/6LuQVn12M ) .

###25651409
OBJECTIVE	To determine whether increased elimination of gadobenate ion via the hepatobiliary pathway might compensate for reduced/absent elimination via the urinary pathway in the event of compromised renal function , as a possible protective mechanism against nephrogenic systemic fibrosis ( NSF ) .
METHODS	15 male Crl : CD ( ) R ( SD ) Br rats ( Charles River Italia , Como , Italy ) randomized to three treatment groups : ( 1 ) animals with occluded bile ducts , ( 2 ) animals with occluded renal vessels and ( 3 ) control animals , each received 0.25 mmol kg ( -1 ) of bodyweight of gadobenate dimeglumine ( MultiHance ( ) ; Bracco Imaging SpA , Milan , Italy ) .
METHODS	Urine and bile were collected from 0-30 , 30-60 , 60-120 , 120-240 and 240-480 min after gadobenate dimeglumine administration prior to exsanguination .
METHODS	Determinations of gadobenate ion in blood , bile and urine were performed by high-performance liquid chromatography .
METHODS	Gadolinium ( Gd ( 3 + ) ) levels in excised liver and kidneys were determined by X-ray fluorescence .
RESULTS	The recovery of gadobenate ion in the urine of rats with bile duct occlusion was significantly higher than that in the urine of normal rats ( 89.1 4.2 % vs 60.6 2.8 % ; p < 0.0001 ) .
RESULTS	Conversely , mean recovery in the bile of rats with renal vessel occlusion was significantly higher than that in the bile of normal rats ( 96.16 0.55 % vs 33.5 4.7 % ; p < 0.0001 ) .
RESULTS	Gadobenate ion was not quantifiable in any group 8 h post-injection .
CONCLUSIONS	Compensatory elimination may be an effective means to overcome compromised renal or hepatobiliary elimination .
CONCLUSIONS	The absence of NSF in at-risk patients administered with gadobenate dimeglumine may in part reflect greater Gd ( 3 + ) elimination via the hepatobiliary route .

###25693013
BACKGROUND	Oral propranolol has been used to treat complicated infantile hemangiomas , although data from randomized , controlled trials to inform its use are limited .
METHODS	We performed a multicenter , randomized , double-blind , adaptive , phase 2-3 trial assessing the efficacy and safety of a pediatric-specific oral propranolol solution in infants 1 to 5 months of age with proliferating infantile hemangioma requiring systemic therapy .
METHODS	Infants were randomly assigned to receive placebo or one of four propranolol regimens ( 1 or 3 mg of propranolol base per kilogram of body weight per day for 3 or 6 months ) .
METHODS	A preplanned interim analysis was conducted to identify the regimen to study for the final efficacy analysis .
METHODS	The primary end point was success ( complete or nearly complete resolution of the target hemangioma ) or failure of trial treatment at week 24 , as assessed by independent , centralized , blinded evaluations of standardized photographs .
RESULTS	Of 460 infants who underwent randomization , 456 received treatment .
RESULTS	On the basis of an interim analysis of the first 188 patients who completed 24 weeks of trial treatment , the regimen of 3 mg of propranolol per kilogram per day for 6 months was selected for the final efficacy analysis .
RESULTS	The frequency of successful treatment was higher with this regimen than with placebo ( 60 % vs. 4 % , P < 0.001 ) .
RESULTS	A total of 88 % of patients who received the selected propranolol regimen showed improvement by week 5 , versus 5 % of patients who received placebo .
RESULTS	A total of 10 % of patients in whom treatment with propranolol was successful required systemic retreatment during follow-up .
RESULTS	Known adverse events associated with propranolol ( hypoglycemia , hypotension , bradycardia , and bronchospasm ) occurred infrequently , with no significant difference in frequency between the placebo group and the groups receiving propranolol .
CONCLUSIONS	This trial showed that propranolol was effective at a dose of 3 mg per kilogram per day for 6 months in the treatment of infantile hemangioma .
CONCLUSIONS	( Funded by Pierre Fabre Dermatologie ; ClinicalTrials.gov number , NCT01056341 . )

###25186159
BACKGROUND	People with type 1 diabetes ( T1DM ) require insulin therapy to sustain life , and need optimal glycaemic control to prevent diabetic ketoacidosis and serious long-term complications .
BACKGROUND	Insulin is generally administered using multiple daily injections but can also be delivered using an infusion pump ( continuous subcutaneous insulin infusion ) , a more costly option with benefits for some patients .
BACKGROUND	The UK National Institute for Health and Care Excellence ( NICE ) recommend the use of pumps for patients with the greatest need , citing insufficient evidence to approve extension to a wider population .
BACKGROUND	Far fewer UK adults use pumps than in comparable countries .
BACKGROUND	Previous trials of pump therapy have been small and of short duration and failed to control for training in insulin adjustment .
BACKGROUND	This paper describes the protocol for a large randomised controlled trial comparing pump therapy with multiple daily injections , where both groups are provided with high-quality structured education .
METHODS	A multicentre , parallel group , cluster randomised controlled trial among 280 adults with T1DM .
METHODS	All participants attended the week-long dose adjustment for normal eating ( DAFNE ) structured education course , and receive either multiple daily injections or pump therapy for 2years .
METHODS	The trial incorporates a detailed mixed-methods psychosocial evaluation and cost-effectiveness analysis .
METHODS	The primary outcome will be the change in glycosylated haemoglobin ( HbA1c ) at 24months in those participants whose baseline HbA1c is at or above 7.5 % ( 58mmol/mol ) .
METHODS	The key secondary outcome will be the proportion of participants reaching the NICE target of an HbA1c of 7.5 % ( 58mmol/mol ) or less at 24months .
BACKGROUND	The protocol was approved by the Research Ethics Committee North West , Liverpool East and received Medicines and Healthcare products Regulatory Agency ( MHRA ) clinical trials authorisation .
BACKGROUND	Each participating centre gave National Health Service R&D approval .
BACKGROUND	We shall disseminate study findings to study participants and through peer reviewed publications and conference presentations , including lay user groups .
BACKGROUND	ISRCTN 61215213 .

###26163093
BACKGROUND	To optimize palliation in incurable locally advanced non-small cell lung cancer ( NSCLC ) , the International Atomic Energy Agency conducted a prospective randomized study ( NCT00864331 ) comparing protracted palliative radiotherapy ( RT ) course with chemotherapy ( CHT ) followed by short-course palliative RT. .
METHODS	Treatment-naive patients with histologically confirmed NSCLC , stage IIIA/IIIB , received either 39Gy in 13 fractions as RT alone ( arm A , n = 31 ) or 2-3 platinum-based CHT cycles followed by 10Gy in a single fraction or 16Gy in 2 fractions separated by one week ( arm B , n = 34 ) .
METHODS	Primary outcome was overall survival .
RESULTS	Treatment groups were balanced with respect to various variables .
RESULTS	Median survival for all 65 patients was 8months , while median survival was 7.1 and 8.1 months for the two arms , respectively ( log-rank p = 0.4 by study arm , and p = 0.6 by Cox regression and stratified by country and sub-stage ) .
RESULTS	One and three year survival rates for the two arms were 29 % , and 9 % and 41 % , and 6 % , respectively .
RESULTS	There were no differences in any of the following endpoints : any failure , local failure , regional failure , contralateral thoracic failure , and distant failure between the two arms .
RESULTS	High-grade ( 3 ) toxicity was similar between the two arms .
RESULTS	Symptoms , adverse events of any kind , KPS and body-mass index , were not different during treatment and during follow-up .
RESULTS	There was no grade 5 toxicity .
CONCLUSIONS	This incomplete and underpowered trial only hinted similar outcome between the treatment arms .
CONCLUSIONS	Therefore , combined CHT-RT can perhaps be considered , in limited resource setting , where access to RT remains inadequate .

###24372674
OBJECTIVE	Medical expulsive therapy ( MET ) using alpha-blockers is effective for distal ureteral calculi ( UC ) .
OBJECTIVE	We aimed to evaluate the efficacy of tamsulosin for proximal UC expulsion .
METHODS	An open-label randomized controlled trial was conducted with 108 patients who agreed to conservative management for single , radiopaque , proximal UC 6 mm and were randomized into group A ( n = 54 , conservative managements only ) or B ( n = 54 , 0.2 mg tamsulosin once a day ) .
METHODS	The primary end-point was stone passage rates ( SPR ) in the intention-to-treat population in 4 treatment weeks .
METHODS	The secondary end-points were estimated in per-protocol population and were time to stone passage , post-trial Euro-quality-of-life ( EuroQOL ) score , oral analgesic requirements , and willingness to undergo conservative treatment again .
RESULTS	The two groups were well balanced in terms of baseline patient and stone characteristics .
RESULTS	Seventy nine patients ( 73.2 % ; 35 of group A and 44 of group B ) completed the study protocol .
RESULTS	The overall SPR was 60.2 % ( 65/108 ) .
RESULTS	Group B had a higher SPR ( 74.1 % ; 40/54 ) than group A ( 46.3 % ; 25/54 ; p = 0.003 ) and a significantly shorter time to stone passage ( mean days , A : 19.6 vs. B : 14.3 , p = 0.005 ) .
RESULTS	The groups did not differ in post-trial EuroQOL score or oral analgesic requirements , whereas 74.3 % ( 26/35 ) of group A and 90.9 % ( 40/44 ) of group B were willing to undergo conservative treatment again ( p = 0.048 ) .
RESULTS	Univariate logistic regression analysis showed that stone size ( OR = 1.447 , p = 0.045 ) and tamsulosin treatment ( OR = 3.314 , p = 0.004 ) significantly predicted stone expulsion .
RESULTS	On multivariate analysis , only tamsulosin was statistically significant ( OR = 3.198 , p = 0.021 ) .
CONCLUSIONS	Tamsulosin was associated with significantly higher stone expulsion rate and shorter expulsion time in proximal UC 6 mm compared with conservative managements only .
CONCLUSIONS	Our results indicate that similar to patients with distal UC , MET using tamsulosin is a reasonable treatment option for patients with proximal UC .

###24580983
BACKGROUND	To address the public health crisis of overweight and obese preschool-age children , the Nutrition And Physical Activity Self Assessment for Child Care ( NAP SACC ) intervention was delivered by nurse child care health consultants with the objective of improving child care provider and parent nutrition and physical activity knowledge , center-level nutrition and physical activity policies and practices , and children 's body mass index ( BMI ) .
METHODS	A seven-month randomized control trial was conducted in 17 licensed child care centers serving predominantly low income families in California , Connecticut , and North Carolina , including 137 child care providers and 552 families with racially and ethnically diverse children three to five years old .
METHODS	The NAP SACC intervention included educational workshops for child care providers and parents on nutrition and physical activity and consultation visits provided by trained nurse child care health consultants .
METHODS	Demographic characteristics and pre - and post-workshop knowledge surveys were completed by providers and parents .
METHODS	Blinded research assistants reviewed each center 's written health and safety policies , observed nutrition and physical activity practices , and measured randomly selected children 's nutritional intake , physical activity , and height and weight pre - and post-intervention .
RESULTS	Hierarchical linear models and multiple regression models assessed individual - and center-level changes in knowledge , policies , practices and age - and sex-specific standardized body mass index ( zBMI ) , controlling for state , parent education , and poverty level .
RESULTS	Results showed significant increases in providers ' and parents ' knowledge of nutrition and physical activity , center-level improvements in policies , and child-level changes in children 's zBMI based on 209 children in the intervention and control centers at both pre - and post-intervention time points .
CONCLUSIONS	The NAP SACC intervention , as delivered by trained child health professionals such as child care health consultants , increases provider knowledge , improves center policies , and lowers BMI for children in child care centers .
CONCLUSIONS	More health professionals specifically trained in a nutrition and physical activity intervention in child care are needed to help reverse the obesity epidemic .
BACKGROUND	National Clinical Trials Number NCT01921842 .

###25218689
BACKGROUND	Chronic disease management presents enormous challenges to the primary care workforce because of the rising epidemic of cardiovascular risk factors .
BACKGROUND	The chronic care model was proven effective in improving chronic disease outcomes in developed countries , but there is little evidence of its effectiveness in developing countries .
BACKGROUND	The aim of this study was to evaluate the effectiveness of the EMPOWER-PAR intervention ( multifaceted chronic disease management strategies based on the chronic care model ) in improving outcomes for type 2 diabetes mellitus and hypertension using readily available resources in the Malaysian public primary care setting .
BACKGROUND	This paper presents the study protocol .
METHODS	A pragmatic cluster randomised controlled trial using participatory action research is underway in 10 public primary care clinics in Selangor and Kuala Lumpur , Malaysia .
METHODS	Five clinics were randomly selected to provide the EMPOWER-PAR intervention for 1 year and another five clinics continued with usual care .
METHODS	Each clinic consecutively recruits type 2 diabetes mellitus and hypertension patients fulfilling the inclusion and exclusion criteria over a 2-week period .
METHODS	The EMPOWER-PAR intervention consists of creating/strengthening a multidisciplinary chronic disease management team , training the team to use the Global Cardiovascular Risks Self-Management Booklet to support patient care and reinforcing the use of relevant clinical practice guidelines for management and prescribing .
METHODS	For type 2 diabetes mellitus , the primary outcome is the change in the proportion of patients achieving HbA1c < 6.5 % .
METHODS	For hypertension without type 2 diabetes mellitus , the primary outcome is the change in the proportion of patients achieving blood pressure < 140/90 mmHg .
METHODS	Secondary outcomes include the proportion of patients achieving targets for serum lipid profile , body mass index and waist circumference .
METHODS	Other outcome measures include medication adherence levels , process of care and prescribing patterns .
METHODS	Patients ' assessment of their chronic disease care and providers ' perceptions , attitudes and perceived barriers in care delivery and cost-effectiveness of the intervention are also evaluated .
CONCLUSIONS	Results from this study will provide objective evidence of the effectiveness and cost-effectiveness of a multifaceted intervention based on the chronic care model in resource-constrained public primary care settings .
CONCLUSIONS	The evidence should instigate crucial primary care system change in Malaysia .
BACKGROUND	ClinicalTrials.gov NCT01545401 .

###25371275
OBJECTIVE	This study compared the therapeutic effect of monotherapy with a nonsteroidal anti-inflammatory drug ( NSAID ) patch vs an NSAID patch combined with transcutaneous electric nerve stimulation ( TENS ) , a heating pad , or topical capsaicin in the treatment of patients with myofascial pain syndrome ( MPS ) of the upper trapezius .
METHODS	A randomized , single-blind , controlled study of combination therapy for patients with MPS was performed .
METHODS	Ninety-nine patients were randomly assigned to one of four different self-management methods for treatment : NSAID patch ( N = 25 ) , NSAID patch + TENS ( N = 24 ) , NSAID patch + heating pad ( N = 25 ) , and NSAID patch + topical capsaicin ( N = 25 ) .
METHODS	The NSAID patch used in this study was a ketoprofen patch .
METHODS	All treatment groups were observed for 2 weeks , and the numeric rating scale ( NRS ) pain score , cervical active range of motion , pressure pain threshold , and Neck Disability Index were assessed .
RESULTS	There was no significant difference between the NSAID patch alone group and the three combination therapy groups with respect to decrease in NRS score from baseline ( day 0 ) to each period of observation .
RESULTS	In covariate analysis , although there was no difference among the groups in most of the periods , the data at day 14 indicated a trend ( P = 0.057 ) .
RESULTS	There were no significant differences in the other variables .
CONCLUSIONS	We did not observe a statistical difference in improvements to the clinical variables among the four different methods .
CONCLUSIONS	However , further studies regarding the effectiveness of a mixture of topical capsaicin and ketoprofen in patients with MPS should be considered .

###24405757
BACKGROUND	In view of freezing of gait 's circumstances of occurrence in Parkinson 's disease , attentional resources appear to be involved in step initiation failure .
BACKGROUND	Anticipatory postural adjustments ( APAs ) are essential because they allow unloading of the stepping leg and so create the conditions required for progression .
BACKGROUND	Our main objective was to establish whether or not a change in attentional load during step initiation modulates APAs differently in patients with vs. without freezing of gait .
METHODS	Three groups of 15 subjects were recruited : elderly people and parkinsonian patients with or without freezing of gait .
METHODS	Attention was modulated before step execution by means of an auditory oddball discrimination task with event-related potential recording .
METHODS	The primary endpoint was the occurrence of inappropriate APAs following the attentional task , i.e. APAs not followed by a step after an intercurrent auditory stimulus .
RESULTS	In parkinsonian patients with freezing of gait , inappropriate APAs were recorded in 63 % of the trials and were observed more frequently than in patients without freezing of gait ( 51 % ) and elderly controls ( 48 % ) .
RESULTS	Furthermore , inappropriate APAs in freezers were longer and more ample than in parkinsonian non-freezers and controls .
RESULTS	Lastly , postural preparation was impaired in the parkinsonian patients .
CONCLUSIONS	Our results indicate that allocation of attentional resources during step preparation influences the release of APAs differently in freezers and non-freezers .
CONCLUSIONS	Modulating attentional load is partly responsible for triggering an inappropriate motor program .
CONCLUSIONS	This difficulty in focusing attention or resisting interference may contribute ( at least in part ) to the gait initiation failure observed in parkinsonian freezers .

###24440364
OBJECTIVE	To determine whether nonparetic arm force overinhibits the paretic arm in patients with chronic unilateral poststroke hemiparesis .
METHODS	Case-control neurophysiological and behavioral study of patients with chronic stroke .
METHODS	Research institution .
METHODS	Eighty-six referred patients were screened to enroll 9 participants ( N = 9 ) with a > 6 month history of 1 unilateral ischemic infarct that resulted in arm hemiparesis with residual ability to produce 1Nm of wrist flexion torque and without contraindication to transcranial magnetic stimulation .
METHODS	Eight age - and handedness-matched healthy volunteers without neurologic diagnosis were studied for comparison .
METHODS	Not applicable .
METHODS	Change in interhemispheric inhibition targeting the ipsilesional primary motor cortex ( M1 ) during nonparetic arm force .
METHODS	We hypothesized that interhemispheric inhibition would increase more in healthy controls than in patients with hemiparesis .
RESULTS	Healthy age-matched controls had significantly greater increases in inhibition from their active to resting M1 than patients with stroke from their active contralesional to resting ipsilesional M1 in the same scenario ( 20 % 7 % vs -1 % 4 % , F1 ,12 = 6.61 , P = .025 ) .
RESULTS	Patients with greater increases in contralesional to ipsilesional inhibition were better performers on the 9-hole peg test of paretic arm function .
CONCLUSIONS	Our findings reveal that producing force with the nonparetic arm does not necessarily overinhibit the paretic arm .
CONCLUSIONS	Though our study is limited in generalizability by the small sample size , we found that greater active contralesional to resting ipsilesional M1 inhibition was related with better recovery in this subset of patients with chronic poststroke .

###25514106
BACKGROUND	For many patients , adhering to postmenopausal osteoporosis treatment is a challenge .
BACKGROUND	Higher treatment satisfaction is associated with greater persistence with these therapies , which is associated with better outcomes .
OBJECTIVE	This study aimed to evaluate the change in treatment satisfaction in postmenopausal women who were suboptimally adherent to daily or weekly oral bisphosphonates and who transitioned to denosumab vs a monthly oral bisphosphonate .
METHODS	Pooled data of outpatients from two international , multicenter , randomized , open-label studies were analyzed .
METHODS	Postmenopausal women ( n = 1703 ) age 55 years or greater with low bone mineral density who were suboptimally adherent with prior oral bisphosphonate therapy , as assessed by the Osteoporosis-Specific Morisky Medication Adherence Scale , were included in the study .
METHODS	Patients received denosumab , a fully human monoclonal antibody to receptor activator of nuclear factor-kappa B ligand , 60 mg s.c. every 6 months vs the oral bisphosphonates ibandronate or risedronate , 150 mg once monthly for 12 months .
METHODS	Change in treatment satisfaction scores from baseline to months 6 and 12 were measured using the Treatment Satisfaction Questionnaire for Medication ( TSQM ) .
METHODS	The TSQM is a validated tool that measures perception of four domains of treatment satisfaction : effectiveness , side effects , convenience , and global satisfaction .
RESULTS	Patients in both treatment groups showed improvement from baseline for all four TSQM domains at 6 and 12 months .
RESULTS	However , the denosumab group had significantly ( all P < .001 ) greater improvements among all four TSQM domains at 6 and 12 months compared with the oral bisphosphonate group .
CONCLUSIONS	Women with low adherence to oral bisphosphonates reported greater treatment satisfaction when transitioned to denosumab vs switching to a monthly oral bisphosphonate .

###24684940
BACKGROUND	Mild hypoxia is common in stroke patients and may have significant adverse effects on the ischemic brain after stroke .
BACKGROUND	The use of oxygen treatment is rapidly increasing in European stroke units but is not without side effects .
BACKGROUND	It impedes early mobilization , could pose an infection risk , and may encourage the formation of toxic free radicals , leading to further damage to the ischemic brain .
BACKGROUND	In the Stroke Oxygen Pilot Study ( 2 or 3L/min for 72hours ) neurological recovery at one week was better in the oxygen group than in controls , and after correction for difference in baseline stroke severity and prognostic factors , there was a trend to better outcome with oxygen at six months .
BACKGROUND	Oxygen was as effective in mild as in severe strokes.Oxygen saturation is lower at night than during the day , and episodes of oxygen desaturation are common during sleep .
BACKGROUND	Nocturnal oxygen supplementation is likely to reduce the burden of hypoxia without interfering with daytime mobilization and rehabilitation.Before wider use of oxygen supplementation becomes established it is important to obtain better evidence on which patients benefit from such treatment .
METHODS	Participants will be randomized to one of three groups : the first will receive continuous oxygen for 72hours ( at a rate of 2 or 3L/min depending on baseline oxygen saturation ) , the second group will receive nocturnal oxygen only ( at a rate of 2 or 3L/min depending on baseline oxygen saturation ) and the third group will not receive any oxygen ( control ) .
METHODS	A baseline assessment is performed at randomization and a one-week follow-up completed .
METHODS	Outcome data at three , six and twelve months will be obtained via a questionnaire sent to the patient by the trial center .
CONCLUSIONS	This study will provide evidence on the effectiveness of oxygen supplementation for the treatment of stroke and whether nocturnal oxygen is a potentially beneficial therapy regimen .
BACKGROUND	This trial is registered with the ISRCTN register ID number ISRCTN52416964 .

###24675911
OBJECTIVE	To investigate the blood pressure ( BP ) responses to cardiovascular stress test after a combined exercise circuit session at moderate intensity .
METHODS	Twenty individuals ( 10 male/10 fem ; 33.4 6.9 years ; 70.2 15.8 kg ; 170.4 11.5 cm ; 22.3 6.8 % body fat ) were randomized in a different days to control session with no exercise or exercise session consisting of 3 laps of the following circuit : knee extension , bench press , knee flexion , rowing in the prone position , squats , shoulder press , and 5 min of aerobic exercise at 75-85 % of age-predicted maximum heart rate and/or 13 on the Borg Rating of Perceived Exertion [ scale of 6 to 20 ] .
METHODS	The sets of resistance exercise consisted of 15 repetitions at ~ 50 % of the estimated 1 repetition maximum test .
METHODS	Systolic blood pressure ( SBP ) and diastolic blood pressure ( DBP ) were measured at rest and during 1h of recovery in both experimental sessions .
METHODS	After that , blood pressure reactivity ( BPR ) was evaluated using the Cold Pressor Test .
RESULTS	During 1h of exercise recovery , there was a reduction in SBP ( 3-6 mmHg ) and DBP ( 2-5 mmHg ) in relation to pre-session rest ( p < 0.01 ) , while this reduction was not observed in the control session .
RESULTS	A decline in BPR ( 4-7 mmHg ; p < 0.01 ) was observed 1h post-exercise session , but not in the control session .
RESULTS	Post-exercise reductions in SBP and DBP were significantly correlated with BPR reductions ( r = 0.50-0 .45 ; p < 0.05 ) .
CONCLUSIONS	A combined exercise circuit session at moderate intensity promoted subsequent post-exercise hypotension and acutely attenuated BPR in response to a cardiovascular stress test .
CONCLUSIONS	In addition , the post-exercise BP reduction was correlated with BPR attenuation in healthy adults of both genders .

###24612825
BACKGROUND	Major depressive disorder ( MDD ) is the leading cause of disability in the developed world , yet broadly effective treatments remain elusive .
BACKGROUND	Up to 40 % of patients with depression are unresponsive to at least two trials of antidepressant medication and thus have `` treatment-resistant depression '' ( TRD ) .
BACKGROUND	There is an urgent need for cost-effective , non-pharmacologic , evidence-based treatments for TRD .
BACKGROUND	Mindfulness-Based Cognitive Therapy ( MBCT ) is an effective treatment for relapse prevention and residual depression in major depression , but has not been previously studied in patients with TRD in a large randomized trial .
METHODS	The purpose of this study was to evaluate whether MBCT is an effective augmentation of antidepressants for adults with MDD who failed to respond to standard pharmacotherapy .
METHODS	MBCT was compared to an active control condition , the Health-Enhancement Program ( HEP ) , which incorporates physical activity , functional movement , music therapy and nutritional advice .
METHODS	HEP was designed as a comparator condition for mindfulness-based interventions to control for non-specific effects .
METHODS	Originally investigated in a non-clinical sample to promote stress reduction , HEP was adapted for a depressed population for this study .
METHODS	Individuals age 18 and older with moderate to severe TRD , who failed to respond to at least two trials of antidepressants in the current episode , were recruited to participate .
METHODS	All participants were taking antidepressants ( Treatment as usual ; TAU ) at the time of enrollment .
METHODS	After signing an informed consent , participants were randomly assigned to either MBCT or HEP condition .
METHODS	Participants were followed for 1year and assessed at weeks 1-7 , 8 , 24 , 36 , and 52 .
METHODS	Change in depression severity , rate of treatment response and remission after 8weeks were the primary outcomes measured by the clinician-rated Hamilton Depression Severity Rating ( HAM-D ) 17-item scale .
METHODS	The participant-rated Quick Inventory of Depression Symptomology ( QIDS-SR ) 16-item scale was the secondary outcome measure of depression severity , response , and remission .
CONCLUSIONS	Treatment-resistant depression entails significant morbidity and has few effective treatments .
CONCLUSIONS	We studied the effect of augmenting antidepressant medication with MBCT , compared with a HEP control , for patients with TRD .
CONCLUSIONS	Analyses will focus on clinician and patient assessment of depression , participants ' clinical global impression change , employment and social functioning scores and quality of life and satisfaction ratings .
BACKGROUND	ClincalTrials.gov identifier : NCT01021254 .

###25350223
OBJECTIVE	To assess the long-term effect on symptoms and quality of life of esomeprazole 20mg once daily , a recommended dose for maintenance therapy of gastroesophageal reflux disease ( GERD ) .
METHODS	This is a post hoc analysis of 5 year data from patients in the LOTUS trial ( ClinicalTrials.gov identifier : NCT00251927 ) who were randomized to esomeprazole 20mg once daily .
METHODS	All participants had chronic , symptomatic GERD responsive to treatment .
METHODS	Gastrointestinal symptoms were assessed by physicians and by using patient-reported outcome instruments .
METHODS	Investigations included gastrointestinal endoscopy ( with biopsy sampling ) , 24 hour esophageal pH monitoring and laboratory measurements .
RESULTS	In total , 157 of 256 patients randomized to esomeprazole 20mg once daily remained on this dose until the end of follow-up or study discontinuation , whereas 99 patients had their dose increased because of inadequate symptom control ( of these , 29 subsequently returned to the allocated dose ) .
RESULTS	On logistic regression , a long objectively defined GERD history , smoking , female sex , absence of Helicobacter pylori infection and high supine baseline acid reflux into the esophagus were associated with an increased likelihood of requiring dose escalation to esomeprazole 40mg daily ( all p < 0.05 ) .
RESULTS	Symptoms were fairly stable and quality of life was normal throughout follow-up in patients remaining on esomeprazole 20mg once daily , with no more than mild symptom severity , and mean ( standard deviation ) percentage time with intraesophageal pH < 4 was reduced from 10.7 ( 10.7 ) pre-randomization to 6.3 ( 10.2 ) at 6 months and 4.9 ( 7.3 ) at 5 years .
RESULTS	The number of serious adverse events was low ( 0.079 per patient per year ) .
CONCLUSIONS	Post hoc analysis with no control group .
CONCLUSIONS	Esomeprazole at a maintenance dose of 20mg once daily offers effective long-term treatment for chronic GERD in patients initially responsive to the medication , with durable symptom control and sustained reductions in intraesophageal acid exposure .

###25090617
BACKGROUND	In the Systolic Hypertension in Europe trial ( NCT02088450 ) , we investigated whether systolic blood pressure variability determines prognosis over and beyond level .
METHODS	Using a computerised random function and a double-blind design , we randomly allocated 4695 patients ( 60 years ) with isolated systolic hypertension ( 160-219 / < 95 mm Hg ) to active treatment or matching placebo .
METHODS	Active treatment consisted of nitrendipine ( 10-40 mg/day ) with possible addition of enalapril ( 5-20 mg/day ) and/or hydrochlorothiazide ( 12.5-25 .0 mg/day ) .
METHODS	We assessed whether on-treatment systolic blood pressure level ( SBP ) , visit-to-visit variability independent of the mean ( VIM ) or within-visit variability ( WVV ) predicted total ( n = 286 ) or cardiovascular ( n = 150 ) mortality or cardiovascular ( n = 347 ) , cerebrovascular ( n = 133 ) or cardiac ( n = 217 ) endpoints .
RESULTS	At 2 years , mean between-group differences were 10.5 mm Hg ( p < 0.0001 ) for SBP , 0.29 units ( p = 0.20 ) for VIM , and 0.07 mm Hg ( p = 0.47 ) for WVV .
RESULTS	Active treatment reduced ( p0 .048 ) cardiovascular ( -28 % ) , cerebrovascular ( -40 % ) and cardiac ( -24 % ) endpoints .
RESULTS	In analyses dichotomised by the median , patients with low vs. high VIM had similar event rates ( p0 .14 ) .
RESULTS	Low vs. high WVV was not associated with event rates ( p0 .095 ) , except for total and cardiovascular mortality on active treatment , which were higher with low WVV ( p0 .0003 ) .
RESULTS	In multivariable-adjusted Cox models , SBP predicted all endpoints ( p0 .0043 ) , whereas VIM did not predict any ( p0 .058 ) .
RESULTS	Except for an inverse association with total mortality ( p = 0.042 ) , WVV was not predictive ( p0 .15 ) .
RESULTS	Sensitivity analyses , from which we excluded blood pressure readings within 6 months after randomisation , 6 months prior to an event or both were confirmatory .
CONCLUSIONS	The double-blind placebo-controlled Syst-Eur trial demonstrated that blood-pressure lowering treatment reduces cardiovascular complications by decreasing level but not variability of SBP .
CONCLUSIONS	Higher blood pressure level , but not higher variability , predicted risk .
BACKGROUND	ClinicalTrials.gov NCT02088450 .

###24838678
OBJECTIVE	The aim of the study was to compare the effect of six ( A6 regimen ) vs two meals a day , breakfast and lunch ( B2 regimen ) , on body weight , hepatic fat content ( HFC ) , insulin resistance and beta cell function .
METHODS	In a randomised , open , crossover , single-centre study ( conducted in Prague , Czech Republic ) , we assigned 54 patients with type 2 diabetes treated with oral hypoglycaemic agents , both men and women , age 30-70 years , BMI 27-50kg / m ( 2 ) and HbA1c 6-11 .8 % ( 42-105mmol / mol ) , to follow two regimens of a hypoenergetic diet , A6 and B2 , each for 12weeks .
METHODS	Randomisation and allocation to trial groups ( n = 27 and n = 27 ) were carried out by a central computer system .
METHODS	Individual calculations of energy requirements for both regimens were based on the formula : ( resting energy expenditure1 .5 ) -2,092 kJ .
METHODS	The diet in both regimens had the same macronutrient and energy content .
METHODS	HFC was measured by proton magnetic resonance spectroscopy .
METHODS	Insulin sensitivity was measured by isoglycaemic-hyperinsulinaemic clamp and calculated by mathematical modelling as oral glucose insulin sensitivity ( OGIS ) .
METHODS	Beta cell function was assessed during standard meal tests by C-peptide deconvolution and was quantified with a mathematical model .
METHODS	For statistical analysis , 22 crossover ANOVA was used .
RESULTS	The intention-to-treat analysis included all participants ( n = 54 ) .
RESULTS	Body weight decreased in both regimens ( p < 0.001 ) , more for B2 ( -2.3 kg ; 95 % CI -2.7 , -2.0 kg for A6 vs -3.7 kg ; 95 % CI -4.1 , -3.4 kg for B2 ; p < 0.001 ) .
RESULTS	HFC decreased in response to both regimens ( p < 0.001 ) , more for B2 ( -0.03 % ; 95 % CI -0.033 % , -0.027 % for A6 vs -0.04 % ; 95 % CI -0.041 % , -0.035 % for B2 ; p = 0.009 ) .
RESULTS	Fasting plasma glucose and C-peptide levels decreased in both regimens ( p < 0.001 ) , more for B2 ( p = 0.004 and p = 0.04 , respectively ) .
RESULTS	Fasting plasma glucagon decreased with the B2 regimen ( p < 0.001 ) , whereas it increased ( p = 0.04 ) for the A6 regimen ( p < 0.001 ) .
RESULTS	OGIS increased in both regimens ( p < 0.01 ) , more for B2 ( p = 0.01 ) .
RESULTS	No adverse events were observed for either regimen .
CONCLUSIONS	Eating only breakfast and lunch reduced body weight , HFC , fasting plasma glucose , C-peptide and glucagon , and increased OGIS , more than the same caloric restriction split into six meals .
CONCLUSIONS	These results suggest that , for type 2 diabetic patients on a hypoenergetic diet , eating larger breakfasts and lunches may be more beneficial than six smaller meals during the day .
CONCLUSIONS	Trial registration ClinicalTrials.gov number , NCT01277471 , completed .
CONCLUSIONS	Funding Grant NT/11238 -4 from Ministry of Health , Prague , Czech Republic and the Agency of Charles University - GAUK No 702312 .

###25189626
BACKGROUND	Invasive treatment ( coronary angiography and intervention if feasible ) of patients with acute coronary syndrome ( ACS ) has been shown to lead to better outcomes than medical therapy alone , but the elderly have been under-represented in many of the studies .
BACKGROUND	In the elderly , medical therapy is common in ACS .
BACKGROUND	Fear of complications related to the procedure and unclear benefit in older patients are common reasons for invasive procedures being withheld .
BACKGROUND	Our hypothesis is that invasive treatment of elderly patients with ACS will lead to a better outcome in terms of survival and quality of life than medical therapy alone , with acceptable risk .
METHODS	This multicenter , randomized controlled trial of patients 80 years of age and over has two parallel treatment arms , a medical group and an invasive group .
METHODS	In Swedish hospitals , 200 patients with non-ST elevation myocardial infarction or unstable angina will be randomized to medical or invasive treatment strategy .
METHODS	The primary outcome measure is the combined endpoint major adverse cardiac or cerebrovascular event ( MACCE ) within one year .
METHODS	Secondary outcome measures include quality of life , angina , and adverse events such as bleeding .
METHODS	Assessments will be conducted during hospitalization , at 1 month after allocation , and at 12 months .
CONCLUSIONS	This study seeks to determine the efficacy and safety of invasive and medical treatment strategies in the elderly with ACS .
CONCLUSIONS	The study is currently recruiting .
BACKGROUND	ClinicalTrials.gov trial identifier : NCT02126202 .
BACKGROUND	Registered on 7 January 2014 .

###25277997
BACKGROUND	Elevated high-sensitivity troponin is associated with increasing disease severity in patients with stable heart failure with reduced ejection fraction , but less is known about the association in heart failure with preserved ejection fraction .
RESULTS	We examined the prevalence of elevated high-sensitivity troponin T ( hs-TnT ) in 298 patients with heart failure with preserved ejection fraction enrolled in the Prospective comparison of angiotensin receptor neprilysin inhibitor with angiotensin receptor blocker on Management Of heart failUre with preserved ejectioN fracTion ( PARAMOUNT ) trial , in which the angiotensin receptor neprilysin inhibitor LCZ696 reduced markers of heart failure severity compared with valsartan .
RESULTS	We assessed the association between hs-TnT and cardiac structure and function , and the effect of LCZ696 , compared with valsartan , on hs-TnT over 36 weeks .
RESULTS	Elevated hs-TnT in the myocardial injury range ( > 0.014 g/L ) was found in 55 % of patients and was associated with older age , history of diabetes mellitus , higher N-terminal pro-brain natriuretic peptide , lower estimated glomerular filtration rate , and larger left atrial size , left ventricular volume , and mass .
RESULTS	LCZ696 treatment reduced hs-TnT to a greater extent at 12 weeks ( 12 % reduction ; P = 0.05 ) and at 36 weeks ( 14 % reduction ; P = 0.03 ) compared with valsartan .
CONCLUSIONS	Troponin T was elevated in a substantial number of patients enrolled in a heart failure with preserved ejection fraction clinical trial and was associated with abnormalities of cardiac structure , function , and elevated baseline N-terminal pro-brain natriuretic peptide .
CONCLUSIONS	Decreases in hs-TnT with LCZ696 in parallel with improvement in N-terminal pro-brain natriuretic peptide and left atrial size suggest that the angiotensin receptor neprilysin inhibitor LCZ696 may reduce this measure of myocardial injury in heart failure with preserved ejection fraction .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00887588 .

###24797423
BACKGROUND	Investigations meeting current standards are limited for the effect of house dust mite ( HDM ) allergy immunotherapy in asthmatic patients .
OBJECTIVE	This trial investigated the efficacy and safety of a standardized quality ( SQ ; allergen standardization method proprietary to the trial sponsor ) HDM SLIT-tablet ( ALK , Hrsholm , Denmark ) in adults and adolescents with HDM respiratory allergic disease .
OBJECTIVE	This publication reports the results of the endpoints related to asthma .
METHODS	Six hundred four subjects 14 years or older with HDM allergic rhinitis and mild-to-moderate asthma were randomized 1:1:1:1 to double-blind daily treatment with one of 3 active doses ( 1 , 3 , or 6 SQ-HDM ) or placebo .
METHODS	Their use of inhaled corticosteroid ( ICS ) was standardized and adjusted at baseline and the end of treatment to the lowest dose providing asthma control .
METHODS	The primary end point was a reduction in ICS dose from the individual subject 's baseline dose after 1 year of treatment .
RESULTS	The primary analysis revealed a mean difference between 6 SQ-HDM and placebo in the reduction in daily ICS dose of 81 g ( P = .004 ) .
RESULTS	Relative mean and median reductions were 42 % and 50 % for 6 SQ-HDM and 15 % and 25 % for placebo , respectively .
RESULTS	No statistically significant differences were observed for the other assessed asthma parameters , reflecting the intended controlled status of the trial subjects .
RESULTS	The most common adverse events were local reactions in the mouth .
RESULTS	The rate and severity of adverse events were higher for 3 and 6 SQ-HDM than for 1 SQ-HDM and placebo .
CONCLUSIONS	Efficacy in mild-to-moderate asthma of 6 SQ-HDM relative to placebo was demonstrated by a moderate statistically significant reduction in the ICS dose required to maintain asthma control .
CONCLUSIONS	All active doses were well tolerated .

###25213159
BACKGROUND	Pill-taking , expectations and therapeutic alliance may account for much of the benefit of medication and placebo treatment for major depressive disorder ( MDD ) .
BACKGROUND	Aims To examine the effects of medication , placebo and supportive care on treatment outcome , and the relationships of expectations and therapeutic alliance to improvement .
METHODS	A total of 88 participants were randomised to 8 weeks of treatment with supportive care alone or combined with double-blind treatment with placebo or antidepressant medication .
METHODS	Expectations of medication effectiveness , general treatment effectiveness and therapeutic alliance were measured ( trial registration at ClinicalTrials.gov : NCT00200902 ) .
RESULTS	Medication or placebo plus supportive care were not significantly different but had significantly better outcome than supportive care alone .
RESULTS	Therapeutic alliance predicted response to medication and placebo ; expectations of medication effectiveness at enrolment predicted only placebo response .
CONCLUSIONS	Pill treatment yielded better outcome than supportive care alone .
CONCLUSIONS	Medication expectations uniquely predicted placebo treatment outcome and were formed by time of enrolment , suggesting that they were shaped by prior experiences outside the clinical trial .

###25795408
BACKGROUND	Adrenocortical carcinoma is a rare , aggressive cancer for which few treatment options are available .
BACKGROUND	Linsitinib ( OSI-906 ) is a potent , oral small molecule inhibitor of both IGF-1R and the insulin receptor , which has shown acceptable tolerability and preliminary evidence of anti-tumour activity .
BACKGROUND	We assessed linsitinib against placebo to investigate efficacy in patients with advanced adrenocortical carcinoma .
METHODS	In this international , double-blind , placebo-controlled phase 3 study , adult patients with histologically confirmed locally advanced or metastatic adrenocortical carcinoma were recruited at clinical sites in nine countries .
METHODS	Patients were randomly assigned ( 2:1 ) twice-daily 150 mg oral linsitinib or placebo via a web-based , centralised randomisation system and stratified according to previous systemic cytotoxic chemotherapy for adrenocortical carcinoma , Eastern Cooperative Oncology Group performance status , and use of one or more oral antihyperglycaemic therapy at randomisation .
METHODS	Allocation was concealed by blinded block size and permuted block randomisation .
METHODS	The primary endpoint was overall survival , calculated from date of randomisation until death from any cause .
METHODS	The primary analysis was done in the intention-to-treat population .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00924989 .
RESULTS	Between Dec 2 , 2009 , and July 11 , 2011 , 139 patients were enrolled , of whom 90 were assigned to linsitinib and 49 to placebo .
RESULTS	The trial was unblinded on March 19 , 2012 , based on data monitoring committee recommendation due to the failure of linsitinib to increase either progression-free survival or overall survival .
RESULTS	At database lock and based on 92 deaths , no difference in overall survival was noted between linsitinib and placebo ( median 323 days [ 95 % CI 256-507 ] vs 356 days [ 249-556 ] ; hazard ratio 094 [ 95 % CI 061-144 ] ; p = 077 ) .
RESULTS	The most common treatment-related adverse events of grade 3 or worse in the linsitinib group were fatigue ( three [ 3 % ] patients vs no patients in the placebo group ) , nausea ( two [ 2 % ] vs none ) , and hyperglycaemia ( two [ 2 % ] vs none ) .
RESULTS	No adverse events in the linsitinib group were deemed to be treatment related ; one death ( due to sepsis and megacolon ) in the placebo group was deemed to be treatment related .
CONCLUSIONS	Linsitinib did not increase overall survival and so can not be recommended as treatment for this general patient population .
CONCLUSIONS	Further studies of IGF-1R and insulin receptor inhibitors , together with genetic profiling of responders , might pave the way toward individualised and improved therapeutic options in adrenocortical carcinoma .
BACKGROUND	Astellas .

###24310050
OBJECTIVE	Many patients experience moderate to severe postoperative pain .
OBJECTIVE	Nitrous oxide ( NO ) exerts analgesia by inhibition of N-methyl-D-aspartate receptors .
OBJECTIVE	Ketamine , another N-methyl-D-aspartate receptor antagonist , reduces postoperative opioid consumption and pain .
OBJECTIVE	A similar effect of NO is plausible , yet understudied .
OBJECTIVE	The goal of this study was to determine the effects of NO anesthesia on early postsurgical opioid consumption and pain .
METHODS	This was a retrospective , secondary analysis of the Vitamins In Nitrous Oxide trial , where 500 patients undergoing general anesthesia for noncardiac surgery received 60 % NO and 125 received no NO ( otherwise , inclusion/exclusion criteria were identical ) .
METHODS	Exclusion criteria for this study were regional anesthesia , not extubated after surgery , transfer to intensive care unit , no available postanesthesia care unit record , postsurgical sedation , or treated with naloxone .
METHODS	Primary outcomes were cumulative opioid consumption measured in morphine equivalents and pain scores during the immediate recovery phase .
RESULTS	Four hundred forty-two patients met inclusion criteria .
RESULTS	No difference in intraoperative and postoperative opioid consumption was observed between patients who received NO ( n = 353 ) and patients who did not ( n = 89 ) .
RESULTS	The median [ interquartile range ] postoperative morphine equivalent dose was 6.7 mg [ 1.7-14 .1 mg ] for patients who received NO and 6.7 mg [ 2.1-15 .4 mg ] for patients who did not ( P = 0.73 ) .
RESULTS	The maximum pain score was 6 [ 4-8 ] for patients who received NO versus 6 [ 3-8 ] for patients who received NO-free anesthesia ( P = 0.52 ) .
RESULTS	The prevalence of moderate to severe pain was 69 % for patients who received NO and 68 % for patients who did not ( P = 0.90 ) .
CONCLUSIONS	Nitrous oxide anesthesia was not associated with decreased opioid administration , pain , or incidence of moderate to severe pain in the early postoperative phase .

###24684103
OBJECTIVE	To determine whether electroacupuncture ( EA ) intervention combined with general anesthesia ( GA ) strategy can reduce early post-operative morbidity and medical costs in patients undergoing heart valve replacement operation under cardiopulmonary bypass .
METHODS	A total of 160 heart valve replacement surgery patients undergoing cardiopulmonary bypass were randomly divided into GA and EA + GA groups ( n = 80 in each group ) .
METHODS	Patients of the GA group were given with intravenous injection of Fentanyl , Midazolam , Vecuronium Bromide , etc. and routine tracheal intubation .
METHODS	EA ( 3-4 Hz , 2.0-2 .2 mA ) was applied to bilateral Zhongfu ( LU 1 ) , Chize ( LU 5 ) and Ximen ( PC 4 ) beginning about 20 mm before the surgery in the EA + GA group .
METHODS	Endotracheal intubation was not employed but only prepared as a standby for patients of the EA + GA group .
METHODS	The dosage of narcotic drugs , duration of surgery , duration of aertic blockage , rate of cardiac re-beating , volumes of post-operative blood transfusion , discharge volume , cases of post-operative pulmonary infection , vocal cord injury , and the time of first bed-off , first eating and duration in intensive care unit ( IOU ) residence .
METHODS	etc. were recorded .
RESULTS	The successful rates of heart valve replacement surgery were similar in both GA and EA + GA groups .
RESULTS	Compared with the GA group , the dosages of Fentanyl , Midazolam and Vecuronium of the EA + GA group were significantly lower ( P < 0.05 , P < 0.01 ) , the numbers of patients needing blood-transfusion , antibiotics treatment , and suffering from pulmonary infection were fewer , the time of first bed-off and duration of hospitalizetion and IOU residence were considerably shorter ( P < 0.05 , P < 0.01 ) and the total medical cost was obviously lower ( P < 0.05 ) in the EA + GA group .
CONCLUSIONS	EA combined with general anesthesia strategy for heart valve replacement surgery without endotracheal intubation is safe and can reduce post-operative morbidity and medical costs in patients undergoing heart valve replacement surgery under cardiopulmonary bypass .

###24559909
OBJECTIVE	To assess the cost-effectiveness of a nurse facilitated , cognitive behavioural self-management programme for patients with heart failure compared with usual care including the un-facilitated access to the same manual , from the perspective of the NHS .
METHODS	Data were obtained from a pragmatic , multi-centre , randomized controlled ` open ' trial conducted in seven centres in the UK between 2006 and 2008 .
METHODS	Effectiveness was estimated as Quality-Adjusted Life Years .
METHODS	Resource use was measured prospectively on all patients using information provided by patients in postal questionnaires , case-note review , electronic record review and interviews with patients .
METHODS	Unit costs were obtained from the literature and applied to the relevant resource use to estimate total costs .
METHODS	Multiple imputation was used to handle missing data .
RESULTS	There were no substantial differences in the utility scores between treatment groups in all follow-up assessments , in the use of medication or outpatient visits and both groups report a similar frequency of contact with health care professionals .
RESULTS	After controlling for baseline utility and using imputed dataset , treatment was associated with a reduction in QALY of 0.004 and a additional cost of 69.49 .
RESULTS	The probability that the intervention is cost-effective for thresholds between 20,000 and 30,000 is around 45 % .
CONCLUSIONS	There is little evidence that the addition of the intervention had any effect on costs or outcomes .
CONCLUSIONS	The uncertainty around both estimates of cost and effectiveness mean that it is not reasonable to make recommendations based on cost-effectiveness alone .

###24486425
BACKGROUND	Major depressive disorder ( MDD ) is frequently associated with underactivity of the dorsolateral prefrontal cortex ( DLPFC ) which has led to this brain region being identified as an important target for the development of neurobiological treatments .
BACKGROUND	Transcranial direct current stimulation ( tDCS ) administered to the DLPFC has antidepressant efficacy , however the magnitude of antidepressant outcomes are limited .
BACKGROUND	Concurrent cognitive activity has been shown to enhance tDCS induced stimulation effects .
BACKGROUND	Cognitive control training ( CCT ) is a new cognitive therapy for MDD that aims to enhance DLPFC activity via behavioral methods .
OBJECTIVE	We tested the hypothesis that co-administration of DLPFC tDCS and CCT would result in a greater reduction in depressive symptomology than administration of tDCS or CCT alone .
METHODS	27 adult participants with MDD were randomized into a three-arm sham-controlled between-groups pilot study comparing the efficacy of 2 mA tDCS + CCT , sham tDCS + CCT and sham CCT + 2 mA tDCS ( 5 sessions administered on consecutive working days ) .
METHODS	Blinded assessments of depression severity and cognitive control were conducted at baseline , end of treatment and a three week follow up review .
RESULTS	All three treatment conditions were associated with a reduction in depression severity at the end of five treatment sessions .
RESULTS	However , only administration of tDCS + CCT resulted in sustained antidepressant response at follow up , the magnitude of which was greater than that observed immediately following conclusion of the treatment course .
CONCLUSIONS	The results provide preliminary evidence that concurrent CCT enhances antidepressant outcomes from tDCS .
CONCLUSIONS	In the current sample , participants receiving concurrent tDCS and CCT continued to improve following cessation of treatment .
CONCLUSIONS	The clinical superiority of a combined therapeutic approach was apparent even in a small sample and following a relatively short treatment course .

###24228894
BACKGROUND	Isolated systolic hypertension is a highly prevalent disease among the elderly .
BACKGROUND	The little available evidence on the efficacy of nitrates for treating the disease is based on small experimental studies .
METHODS	We performed a multicenter , randomized , double-blind , phase III , placebo-controlled trial in 154 patients aged over 65 years with refractory isolated systolic hypertension .
METHODS	Patients were randomized to placebo or 40 mg/day of extended-release isosorbide mononitrate added to standard therapy and titrated to 60 mg/day at week 6 if blood pressure exceeded 140/90 mmHg.The primary objective was to assess the effect on clinical pulse pressure of extended-release isosorbide mononitrate added to standard therapy in patients aged over 65 years with refractory isolated systolic hypertension after 3 months of treatment.The secondary objectives were as follows : to quantify the effect of adding the study drug on central blood pressure and vascular compliance using the augmentation index and pulse wave velocity ; to evaluate the safety profile by recording adverse effects ( frequency , type , severity ) and the percentage of patients who had to withdraw from the trial because of adverse events ; to quantify the percentage of patients who reach a clinical systolic blood pressure < 140 mmHg or < 130 mmHg measured by ambulatory blood pressure monitoring ; and to quantify the change in pulse pressure measured by ambulatory blood pressure monitoring .
CONCLUSIONS	Few clinical trials have been carried out to test the effect of oral nitrates on isolated systolic hypertension , even though these agents seem to be effective .
CONCLUSIONS	Treatment with extended-release isosorbide mononitrate could improve control of systolic blood pressure without severe side effects , thus helping to reduce the morbidity and mortality of the disease .
BACKGROUND	EUDRACT Number : 2012-002988-10 .

###24725475
BACKGROUND	Acne scarring remains a stubborn clinical problem .
BACKGROUND	Few treatments have been shown to bedefinitely effective for this problem .
BACKGROUND	Polymethylmethacrylate ( PMMA ) microspheres in collagen ( ArteFill , Suneva Medical Inc , Santa Barbara , CA ) have shown long-term benefit for nasolabial fold treatment .
BACKGROUND	A pilot study has shown benefit for PMMA-collagen in atrophic acne scarring .
OBJECTIVE	We sought to demonstrate the safety and effectiveness of PMMA-collagen for acne scarring in a controlled , blinded trial .
METHODS	Subjects with at least 4 moderate to severe rolling , atrophic scars randomly received PMMA-collagen or saline injections .
METHODS	Subjects underwent up to 2 injection sessions and were followed up for 6 months .
METHODS	Efficacy was assessed using a validated rating scale for each scar .
RESULTS	In all , 147 subjects underwent injections .
RESULTS	Success was achieved by 64 % of those treated with PMMA-collagen compared with 33 % of control subjects ( P = .0005 ) .
RESULTS	The treatment showed excellent safety with generally mild , reversible adverse events .
RESULTS	No significant differences in efficacy or safety were noted between genders , for darker skin types , or in older age groups .
CONCLUSIONS	Subjects were followed up for only 6 months .
CONCLUSIONS	PMMA-collagen demonstrates substantial effectiveness in the treatment of atrophic acne scars of the face while maintaining an excellent safety profile .
CONCLUSIONS	Further follow-up should be undertaken to demonstrate longer-term benefit and safety .

###24376273
BACKGROUND	Parenteral artesunate is recommended as first-line therapy for severe malaria .
BACKGROUND	While its efficacy is firmly established , data on safety are still incomplete .
BACKGROUND	Delayed hemolysis has been described in hyperparasitemic nonimmune travelers , but it is unknown if African children are equally at risk .
METHODS	Children aged 6 to 120 months with severe malaria were followed up after treatment with parenteral artesunate in Lambarn , Gabon , and Kumasi , Ghana .
METHODS	The primary outcome was incidence of delayed hemolysis on day 14 .
RESULTS	In total , 72 children contributed complete data sets necessary for primary outcome assessment .
RESULTS	Delayed hemolysis was detected in 5 children ( 7 % ) , with 1 child reaching a nadir in hemoglobin of 2.8 g/dL .
RESULTS	Patients with delayed hemolysis had higher parasite counts on admission ( geometric mean parasite densities ( GMPD ) 306 968/L vs 92 642/L , P = .028 ) and were younger ( median age : 24 months vs 43 months , P = .046 ) than the rest of the cohort .
RESULTS	No correlation with sickle cell trait or glucose-6-phosphate-dehydrogenase deficiency was observed .
CONCLUSIONS	Delayed hemolysis is a frequent and relevant complication in hyperparasitemic African children treated with parenteral artesunate for severe malaria .
CONCLUSIONS	Physicians should be aware of this complication and consider prolonged follow-up .
BACKGROUND	Pan-African Clinical Trials Registry : PACTR201102000277177 ( www.pactr.org ) .

###25058845
BACKGROUND	Increased arterial stiffness as measured by aortic pulse wave velocity ( aPWV ) predicts cardiovascular events and mortality and is elevated in patients with COPD .
BACKGROUND	Prior investigation suggests that a long-acting - agonist ( LABA ) / inhaled corticosteroid ( ICS ) lowers aPWV in patients with baseline aPWV 11 m/s .
BACKGROUND	This study compared the effect of the ICS/LABA fluticasone furoate/vilanterol ( FF/VI ) , 100/25 g , delivered via the ELLIPTA dry powder inhaler , with tiotropium bromide ( TIO ) , 18 g , on aPWV .
METHODS	This multicenter , randomized , blinded , double-dummy , parallel-group , 12-week study compared FF/VI and TIO , both administered once daily .
METHODS	The primary end point was aPWV change from baseline at 12 weeks .
METHODS	Safety end points included adverse events ( AEs ) , vital signs , and clinical laboratory tests .
RESULTS	Two hundred fifty-seven patients with COPD and aPWV 11 m/s were randomized ; 87 % had prior cardiovascular events and/or risk .
RESULTS	The mean difference in aPWV between FF/VI and TIO at week 12 was not significant ( P = .484 ) .
RESULTS	Because the study did not contain a placebo arm , a post hoc analysis was performed to show that both treatments lowered aPWV by an approximate difference of 1 m/s compared with baseline .
RESULTS	The proportion of patients reporting AEs was similar with FF/VI ( 24 % ) and TIO ( 18 % ) .
RESULTS	There were no changes in clinical concern for vital signs or clinical laboratory tests .
CONCLUSIONS	No differences on aPWV were observed between FF/VI and TIO .
CONCLUSIONS	However , further studies with a placebo arm are required to establish definitively whether long-acting bronchodilators lower aPWV .
CONCLUSIONS	Both treatments demonstrated an acceptable tolerability profile .
BACKGROUND	ClinicalTrials.gov ; No. : NCT01395888 ; URL : www.clinicaltrials.gov .

###25117183
OBJECTIVE	Vandetanib is a selective inhibitor of vascular endothelial growth factor receptor ( VEGFR ) , epidermal growth factor receptor ( EGFR ) and rearranged during transfection ( RET ) signalling , indicated for the treatment of medullary thyroid cancer .
OBJECTIVE	We investigated potential drug-drug interactions between vandetanib and metformin [ organic cation transporter 2 ( OCT2 ) substrate ; NCT01551615 ] ; digoxin [ P-glycoprotein ( P-gp ) substrate ; NCT01561781 ] ; midazolam [ cytochrome P450 ( CYP ) 3A4 substrate ; NCT01544140 ] ; omeprazole ( proton pump inhibitor ) or ranitidine ( histamine H2-receptor antagonist ; both NCT01539655 ) .
METHODS	Four open-label , phase I studies were conducted in healthy volunteers : n = 14 ( metformin ) , n = 14 ( digoxin ) , n = 17 ( midazolam ) , n = 16 ( omeprazole ) , n = 18 ( ranitidine ) .
METHODS	Three of these comprised the following regimens : metformin 1000mgvandetanib 800mg , midazolam 7.5 mgvandetanib 800mg , or digoxin 0.25 mgvandetanib 300mg .
METHODS	The randomized study comprised vandetanib 300mg alone and then either ( i ) omeprazole 40mg ( days 1-4 ) , and omeprazole + vandetanib ( day 5 ) ; or ( ii ) ranitidine 150mg ( day 1 ) , and ranitidine + vandetanib ( day 2 ) .
METHODS	The primary objective assessed metformin , digoxin , midazolam and vandetanib pharmacokinetics .
RESULTS	Vandetanib + metformin increased metformin area under the plasma concentration-time curve from zero to infinity ( AUC0 - ) and maximum observed plasma concentration ( Cmax ) by 74 and 50 % , respectively , and decreased the geometric mean metformin renal clearance ( CLR ) by 52 % versus metformin alone .
RESULTS	Vandetanib + digoxin increased digoxin area under the concentration-time curve from zero to the last quantifiable concentration ( AUC0-last ) and Cmax by 23 and 29 % , respectively , versus digoxin alone , with only a 9 % decrease in CLR .
RESULTS	Vandetanib had no effect on midazolam exposure .
RESULTS	Vandetanib exposure was unchanged during co-administration with omeprazole/ranitidine .
RESULTS	Treatment combinations were generally well tolerated .
CONCLUSIONS	Patients receiving vandetanib with metformin/digoxin may require additional monitoring of metformin/digoxin , with dose adjustments where necessary .
CONCLUSIONS	Vandetanib with CYP3A4 substrates or omeprazole/ranitidine is unlikely to result in clinically relevant drug-drug interactions .

###24669876
OBJECTIVE	To compare efficacy and safety of hydroxychloroquine with pioglitazone in type 2 diabetes mellitus ( T2DM ) .
METHODS	This double-blind study randomized 267 uncontrolled type 2 diabetes patients ( HbA1c 7.5 % and 11.5 % ) , post 3 months ' treatment with glimepiride/gliclazide and metformin , to additionally receive hydroxychloroquine 400mg/day ( n = 135 ) or pioglitazone 15mg/day ( n = 132 ) for 24 weeks .
METHODS	Efficacy was assessed by changes in HbA1c , fasting ( FBG ) and post-prandial ( PPG ) blood glucose at Week 12 and Week 24 .
RESULTS	At Week 12 and Week 24 , HbA1c , FBG and PPG significantly reduced from baseline in both groups .
RESULTS	Mean reduction in glycemic parameters at Week 12 ( HbA1c : -0.56 % vs -0.72 % , p = 0.394 ; FBG : -0.99 mmol/L vs -1.05 mmol/L , p = 0.878 ; PPG : -1.93 mmol/L vs -1.52 mmol/L , p = 0.423 ) and Week 24 ( HbA1c : -0.87 % vs -0.90 % , p = 0.909 ; FBG : -0.79 mmol/L vs -1.02 mmol/L , p = 0.648 ; PPG : -1.77 mmol/L vs -1.36 mmol/L , p = 0.415 ) was not significantly different between the hydroxychloroquine and pioglitazone groups .
RESULTS	Change in total cholesterol ( TC ) and LDL-C was significant in favor of hydroxychloroquine ( TC : -0.37 mmol/L vs 0.03 mmol/L , p = 0.002 ; LDL-C : -0.23 mmol/L vs 0.09 mmol/L , p = 0.003 ) .
RESULTS	Triglycerides significantly reduced in both groups at Week 24 .
RESULTS	Mean HDL-C remained unchanged .
RESULTS	Study treatments were well tolerated .
CONCLUSIONS	With favorable effects on glycemic parameters and lipids , hydroxychloroquine may emerge as well tolerated therapeutic option for T2DM .
CONCLUSIONS	The sample size for this study was small .
CONCLUSIONS	However , based on the encouraging results of this proof-of-concept study , longer duration studies in larger population can be conducted to further confirm these findings .
CONCLUSIONS	TRIAL REGISTRATION DETAILS : Clinical Trial Registry-India URL : http://ctri.nic.in , Registration Number : CTRI/2009/091 / 001036 .

###24661050
BACKGROUND	Swirling flow , organized in vortices , contributes to adequate left ventricular function .
BACKGROUND	In this study , we apply a novel echocardiographic flow-mapping technique , vector flow mapping ( VFM ) , to evaluate the main characteristics of left ventricular vortices and its relation to filling parameters .
METHODS	Forty-eight subjects underwent conventional transthoracic echocardiographic examination with additional intracardiac flow assessment with VFM using a Aloka Alpha-10 system and experimental VFM analysis software .
METHODS	To analyze vortex behavior , its rotation direction , duration , location inside the left ventricle , size , and intensity were assessed in apical long-axis view .
METHODS	Its relation to conventional left ventricular filling parameters was then analyzed .
RESULTS	Two vortex components were consistently identified following each transmitral filling wave .
RESULTS	The anterior component of these visualized vortices was analyzed , due to its higher significance in the cardiac cycle , following early filling ( V1 ) and atrial contraction ( V2 ) .
RESULTS	Differences were observed in several aspects of vortex behavior between V1 and V2 , particularly in patients with normal left ventricular filling parameters .
RESULTS	These differences may be related to varying roles of vortices in different periods of the cardiac cycle .
CONCLUSIONS	Vector flow mapping allowed visualization and measurement of several parameters defining vortex behavior inside the cardiac cycle .
CONCLUSIONS	The differences observed in these parameters between vortices in different phases of the cardiac cycle may be related to their role in optimizing cardiac function .

###25387477
OBJECTIVE	Assess golimumab efficacy/safety through 5years in patients with active ankylosing spondylitis ( AS ) .
METHODS	356 patients with AS were randomly assigned to placebo , golimumab 50mg or 100mg every 4weeks .
METHODS	At week 16 , patients with inadequate response early escaped with blinded dose adjustments ( placebo to 50mg , 50mg to 100mg ) .
METHODS	At week 24 , all patients receiving placebo crossed over to 50mg .
METHODS	Blinded active therapy continued through week 104 ; from week 104 to week 252 , the golimumab dose could be adjusted .
METHODS	Intent-to-treat and observed efficacy data were assessed by randomised treatment groups .
RESULTS	At week 256 , and with > 4.5 years of golimumab , overall intent-to-treat Assessment in SpondyloArthritis international Society criteria for 20 % improvement ( ASAS20 ) and ASAS40 response rates were 66.0 % ( 235/356 ) and 57.0 % ( 203/356 ) , respectively ; Bath AS Disease Activity Index 50 % improvement response was 55.9 % ( 199/356 ) .
RESULTS	Observed response rates among the 255 ( 72 % ) patients who continued golimumab through week 252 were consistent , albeit somewhat higher .
RESULTS	Among patients who increased golimumab from 50 to 100mg , 60.6 % ( 20/33 ) and 44.7 % ( 17/38 ) achieved ASAS20/ASAS40 responses , respectively , following 2 consecutive doses of golimumab 100mg .
RESULTS	Golimumab safety through week 268 was similar to that through week 24 regardless of dose .
CONCLUSIONS	Clinical improvements observed in patients treated with golimumab through week 24 were sustained through week 256 ( 5years ) .
CONCLUSIONS	Long-term golimumab safety is consistent with that of other established tumour-necrosis-factor-antagonists .
BACKGROUND	ClinicalTrials.gov : NCT00265083 .

###25428140
BACKGROUND	Attention-Deficit/Hyperactivity Disorder ( ADHD ) in adults is one of the predictive and treatable risk factors for delinquency , including intimate partner violence ( IPV ) .
BACKGROUND	Effective treatment of IPV needs to address personal dynamic risk factors , offender typology , and dynamics of the domestic violence .
BACKGROUND	It is unknown whether treatment of ADHD symptoms contributes to a decrease in IPV .
BACKGROUND	The ITAP study aims to investigate the relationship between treatment of ADHD symptoms and IPV in patients in forensic mental health care .
BACKGROUND	Moreover , this study examines the role of comorbid psychopathology , subtype of the offender , and dynamics of the domestic violence .
METHODS	The ITAP study is a longitudinal observational study .
METHODS	Participants are followed one year through various assessments : one before starting treatment ( t0 ) , and four during treatment ( 8 , 16 , 24 and 52 weeks after start of the treatment ) .
METHODS	All participants receive treatment for IPV , ADHD , and comorbid psychopathology , if present .
METHODS	The primary outcome measure is the change in severity of IPV ; the primary predictive variable is the change in severity of ADHD symptoms .
METHODS	The secondary outcome measure is the observation of the therapist about change in the offender 's general violent behaviour , within and outside the partner relationship .
METHODS	Data are analysed in a multiple regression model with change in severity of IPV as the dependent variable and change in severity of ADHD symptoms as the primary predictor .
METHODS	Other predictive variables taken into account in the analyses are presence of comorbid psychopathology and personality disorder , subtype of the offender , and dynamics of the domestic violence .
METHODS	In addition , compliance with treatment and content of the treatment are documented .
CONCLUSIONS	Research on the treatment process of IPV offenders and victims is complicated by many factors .
CONCLUSIONS	This observational design will not allow inferences about causality but may reveal clinically important factors that contribute to more effective treatment of IPV .
BACKGROUND	The Netherlands National Trial Register ( NTR ) , trial ID NTR3887 .

###24747297
BACKGROUND	Nitrogen dioxide ( NO2 ) , a ubiquitous atmospheric pollutant , may enhance the asthmatic response to allergens through eosinophilic activation in the airways .
BACKGROUND	However , the effect of NO2 on inflammation without allergen exposure is poorly studied .
OBJECTIVE	We investigated whether repeated peaks of NO2 , at various realistic concentrations , induce changes in airway inflammation in asthmatics .
METHODS	Nineteen nonsmokers with asthma were exposed at rest in a double-blind , crossover study , in randomized order , to 200 ppb NO2 , 600 ppb NO2 , or clean air once for 30 min on day 1 and twice for 30 min on day 2 .
METHODS	The three series of exposures were separated by 2 weeks .
METHODS	The inflammatory response in sputum was measured 6 hr ( day 1 ) , 32 hr ( day 2 ) , and 48 hr ( day 3 ) after the first exposure , and compared with baseline values measured twice 10-30 days before the first exposure .
RESULTS	Compared with baseline measurements , the percentage of eosinophils in sputum increased by 57 % after exposure to 600 ppb NO2 ( p = 0.003 ) but did not change significantly after exposure to 200 ppb .
RESULTS	The slope of the association between the percentage of eosinophils and NO2 exposure level was significant ( p = 0.04 ) .
RESULTS	Eosinophil cationic protein in sputum was highly correlated with eosinophil count and increased significantly after exposure to 600 ppb NO2 ( p = 0.001 ) .
RESULTS	Lung function , which was assessed daily , was not affected by NO2 exposure .
CONCLUSIONS	We observed that repeated peak exposures of NO2 performed without allergen exposure were associated with airway eosinophilic inflammation in asthmatics in a dose-related manner .

###25012813
BACKGROUND	Musculoskeletal pain is a major contributor to short and long term work absence .
BACKGROUND	Patients seek care from their general practitioner ( GP ) and yet GPs often feel ill-equipped to deal with work issues .
BACKGROUND	Providing a vocational case management service in primary care , to support patients with musculoskeletal problems to remain at or return to work , is one potential solution but requires robust evaluation to test clinical and cost-effectiveness .
METHODS	This protocol describes a cluster randomised controlled trial , with linked qualitative interviews , to investigate the effect of introducing a vocational advice service into general practice , to provide a structured approach to managing work related issues in primary care patients with musculoskeletal pain who are absent from work or struggling to remain in work .
METHODS	General practices ( n = 6 ) will be randomised to offer best current care or best current care plus a vocational advice service .
METHODS	Adults of working age who are absent from or struggling to remain in work due to a musculoskeletal pain problem will be invited to participate and 330 participants will be recruited .
METHODS	Data collection will be through patient completed questionnaires at baseline , 4 and 12 months .
METHODS	The primary outcome is self-reported work absence at 4 months .
METHODS	Incremental cost-utility analysis will be undertaken to calculate the cost per additional QALY gained and incremental net benefits .
METHODS	A linked interview study will explore the experiences of the vocational advice service from the perspectives of GPs , nurse practitioners ( NPs ) , patients and vocational advisors .
CONCLUSIONS	This paper presents the rationale , design , and methods of the Study of Work And Pain ( SWAP ) trial .
CONCLUSIONS	The results of this trial will provide evidence to inform primary care practice and guide the development of services to provide support for musculoskeletal pain patients with work-related issues .
BACKGROUND	Current Controlled Trials ISRCTN52269669 .

###24292873
OBJECTIVE	To investigate whether prophylactic postoperative NIV prevents respiratory complications following lung resection surgery in COPD patients .
METHODS	In seven thoracic surgery departments , 360 COPD patients undergoing lung resection surgery were randomly assigned to two groups : conventional postoperative treatment without ( n = 179 ) or with ( n = 181 ) prophylactic NIV , applied intermittently during 6 h per day for 48 h following surgery .
METHODS	The primary endpoint was the rate of acute respiratory events ( ARE ) at 30 days postoperatively ( ITT analysis ) .
METHODS	Secondary endpoints were acute respiratory failure ( ARF ) , intubation rate , mortality rate , infectious and non-infectious complications , and duration of ICU and hospital stay .
RESULTS	ARE rates did not differ between the prophylactic NIV and control groups ( 57/181 , 31.5 vs. 55/179 , 30.7 % , p = 0.93 ) .
RESULTS	ARF rate was 18.8 % in the prophylactic NIV group and 24.5 % in controls ( p = 0.20 ) .
RESULTS	Re-intubation rates were similar in the prophylactic NIV and control group [ 10/181 ( 5.5 % ) and 13/179 ( 7.2 % ) , respectively , p = 0.53 ] .
RESULTS	Mortality rates were 5 and 2.2 % in the control and prophylactic NIV groups , respectively ( p = 0.16 ) .
RESULTS	Infectious and non-infectious complication rates , and duration of ICU and hospital stays were similar between groups .
CONCLUSIONS	Prophylactic postoperative NIV did not reduce the rate of ARE in COPD patients undergoing lung resection surgery and did not influence other postoperative complications rates , mortality rates , and duration of ICU and hospital stay .

###25344589
OBJECTIVE	Aspirin exacerbated respiratory disease ( AERD ) is comprised of aspirin/acetylsalicylic acid ( ASA ) sensitivity , bronchial asthma , and nasal polyposis .
OBJECTIVE	Treatment of this condition is challenging and may include topical/systemic steroids , endoscopic sinus surgery , and/or aspirin desensitization .
METHODS	A prospective crossover pilot study ( n = 10 ) was conducted in which patients were randomized into either of 2 groups with 6 weeks of regular diet ( R ) or 6 weeks of a low salicylate diet ( LS ) .
METHODS	The study was conducted in a tertiary otolaryngology clinic .
METHODS	Patients with AERD were enrolled in the study .
METHODS	Subjective ( Sino-nasal Outcome Test-22 [ SNOT-22 ] , Nasal Sinus Symptom Scale [ NSSS ] , and the Asthma Control Questionnaire-7 [ ACQ-7 ] ) and objective outcome instruments ( Peri-Operative Sinus Evaluation [ POSE ] and Lund-Kennedy Endoscopic Score [ LKES ] ) were used to evaluate patients at baseline , 6 weeks ( at crossover ) , and 12 weeks .
RESULTS	Wilcoxon rank sum tests demonstrated that patients on the low salicylate diet had improved scores compared to their regular diet when evaluated by 4 of the 5 outcome measures ( SNOT-22 pLS = 0.0059 , NSSS pLS = 0.0195 , LKES pLS = 0.0039 , POSE pLS = 0.005 ) .
CONCLUSIONS	Results of the pilot study indicate that implementation of a low salicylate diet improves the nasal symptoms and nasal endoscopy findings of individuals with AERD .
CONCLUSIONS	Further research is required to support these findings .

###24506834
BACKGROUND	Although the standard treatment for venous ulcers is compression , drugs may be used as adjunctive therapy .
BACKGROUND	Simvastatin has shown potential wound-healing properties ; however , no studies have investigated its use in venous ulcers .
OBJECTIVE	To assess the efficacy and safety of simvastatin in venous ulcer healing when combined with standard treatment for ulcers .
METHODS	This was a randomized , double-blind , placebo-controlled trial .
METHODS	Outcome measures were the proportion of healed ulcers , healing time , total surface area healed and Dermatology Life Quality Index ( DLQI ) scores .
RESULTS	Sixty-six patients were randomized into two groups : a simvastatin ( n = 32 ) and a control ( n = 34 ) group .
RESULTS	Among ulcers 5cm , 100 % were healed in the simvastatin group , and 50 % were healed in the control group [ relative risk ( RR ) 010 , 95 % confidence interval ( CI ) 00141-0707 ] .
RESULTS	The average healing times for ulcers 5cm were 689078weeks and 840113weeks for the simvastatin and control groups , respectively ( P < 0001 ) .
RESULTS	Among ulcers > 5cm , 67 % closed in the simvastatin group , with a mean healing time of 917107weeks .
RESULTS	No ulcers of this size closed in the control group ( RR 033 , 95 % CI 0132-0840 ) .
RESULTS	The simvastatin group had lower DLQI scores ( P < 0001 ) post-treatment .
RESULTS	No adverse effects were documented .
CONCLUSIONS	Simvastatin 40mg daily , in addition to standard wound care and compression , is associated with a significant improvement in healing rate and time , as well as an improved patient quality of life when compared with placebo in the management of venous ulcers .

###25065959
BACKGROUND	How platelet ( PLT ) product characteristics such as dose , source ( whole blood derived [ WBD ] vs. apheresis ) , storage duration , and ABO matching status affect the risks of transfusion-related adverse events ( TRAEs ) is unclear .
BACKGROUND	Similarly , more information is needed to define how recipient characteristics affect the frequency of TRAEs after PLT transfusion .
METHODS	In the multicenter Platelet Dose ( `` PLADO '' ) study , pediatric and adult hematology-oncology patients with hypoproliferative thrombocytopenia were randomized to receive low-dose ( LD ) , medium-dose ( MD ) , or high-dose ( HD ) PLT prophylaxis for a pretransfusion PLT count of not more than 1010 ( 9 ) / L. All PLT units ( apheresis or WBD ) were leukoreduced .
METHODS	Post hoc analyses of PLADO data were performed using multipredictor models .
RESULTS	A total of 5034 PLT transfusions to 1102 patients were analyzed .
RESULTS	A TRAE occurred with 501 PLT transfusions ( 10.0 % ) .
RESULTS	The most common TRAEs were fever ( 6.6 % of transfusions ) , allergic or hypersensitivity reactions ( 1.9 % ) , and sinus tachycardia ( 1.8 % ) .
RESULTS	Patients assigned HD PLTs were more likely than LD or MD patients to experience any TRAE ( odds ratio for HD vs. MD , 1.50 ; 95 % confidence interval , 1.10-2 .05 ; three-group comparison p = 0.02 ) .
RESULTS	PLT source and ABO matching status were not significantly related to overall TRAE risk .
RESULTS	Compared to a patient 's first PLT transfusion , subsequent PLT transfusions were less likely to have a TRAE reported , primarily due to a lower risk of allergic or hypersensitivity reactions .
CONCLUSIONS	The most important PLT unit characteristic associated with TRAEs was PLT dose per transfusion .
CONCLUSIONS	HD PLTs may increase the risk of TRAEs , and LD PLTs may reduce the risk .

###25358723
BACKGROUND	Epilepsy is a complex chronic disorder which affects health-related quality of life ( HRQOL ) , especially in women .
METHODS	This study is a pragmatic randomised controlled trial involving women with epilepsy ( WWE ) over 18 years of age .
RESULTS	One hundred eighty-two WWE entered the study and 144 ( 79.1 % ) completed it .
RESULTS	The t-test for comparing the final QOLIE-31 scores between groups yielded a t = -2.166 and confidence interval ( CI ) ( 95 % ) : -10.125 ; -0.4625 , p-value = 0.0319 .
RESULTS	The change ( ) in the QOLIE-31 score for the IG was 12.45 points ( p-value < 0.001 ) and for the control group it was 2.61 ( p-value = 0.072 ) .
RESULTS	With 10.7 as the minimally important change we found a relative risk of 2.17 ( CI : 1.37 ; 3.43 ) and a number needed to treat ( NNT ) of 3.5 .
CONCLUSIONS	The study demonstrated that the application of a pharmaceutical care programme significantly improves HRQOL in WWE .
CONCLUSIONS	The NNT we found allows a recommendation to implement the PC programme for the additional benefit that would be obtained in patients ' HRQOL .
BACKGROUND	Current Controlled Trials ISRCTN46864306 IPHIWWE study .

###25313756
OBJECTIVE	To determine the effect of moderate-intensity aerobic exercise on the quality of life ( QOL ) and physical functioning in breast cancer survivors .
METHODS	We randomly assigned 62 breast cancer survivors to an exercise ( N = 30 ) or control group ( N = 32 ) .
METHODS	The exercise group trained at a moderate intensity progressing from 25 to 40 min over a 10-week period .
METHODS	The control group did not train .
METHODS	Outcomes were assessed at baseline and postintervention .
METHODS	The primary outcomes were overall QOL -- as assessed by the functional assessment of cancer therapy-breast ( FACT-B ) scale .
METHODS	Secondary outcomes were changes in various subscales of overall QOL , and changes in body composition outcomes : body weight , body mass index , and changes in performance in a 12 min walk test ( 12MWT ) .
RESULTS	Sixty-two of 73 women randomized ( 84.9 % ) completed the study .
RESULTS	There were no significant differences amongst the two groups at baseline for any variable .
RESULTS	In the exercise group significant improvements were demonstrated for the FACT-B ( 13.4 points , P < 0.003 ) , functional assessment of cancer therapy-general ( FACT-G ) ( 9.16 points , P < 0.008 ) , the functional well-being subscale ( P < 0.010 ) , and the emotional well-being subscale ( P < 0.035 ) compared to the control group .
RESULTS	No significant changes in body weight or BMI were observed .
RESULTS	Exercise group showed a significant increase in 12MWT ( P < 0.009 ) .
CONCLUSIONS	We conclude that 10 week of moderate-intensity aerobic exercise program significantly improves QOL and physical functioning in breast cancer survivors .
CONCLUSIONS	Future studies are needed to evaluate the effectiveness of similar exercise programs over longer periods of time and involving a greater number of breast cancer survivors .

###25288624
BACKGROUND	The most common technique for posterior cruciate ligament ( PCL ) reconstruction is transtibial or tibial inlay .
BACKGROUND	However , few studies have reported long-term outcome comparisons between the 2 techniques .
OBJECTIVE	Tibial inlay PCL reconstruction with patellar tendon autograft will exhibit better clinical and radiographic outcomes than transtibial PCL reconstruction with hamstring autograft .
METHODS	Cohort study ; Level of evidence , 3 .
METHODS	A total of 66 patients ( 66 knees ) treated with PCL reconstruction for chronic injuries constituted the study cohort .
METHODS	Patients were divided into 2 groups : transtibial with hamstring ( 36 patients ) and tibial inlay with patellar tendon ( 30 patients ) .
METHODS	The mean time from injury to reconstruction was 12.2 months ( range , 2-60 months ) , and the mean follow-up was 148 months ( range , 98-196 months ) .
METHODS	Outcomes were measured by use of Lysholm knee scores , Tegner activity scores , return to preinjury sports activity , posterior drawer test , laxity test with a Telos device , and development of osteoarthritis .
RESULTS	The preoperative mean Lysholm knee score was 59.9 ( range , 37-70 ) in the transtibial group and 54.5 ( range , 22-76 ) in the tibial inlay group , improving postoperatively to 89.9 ( range , 74-100 ) and 92.1 ( range , 80-100 ) , respectively .
RESULTS	The mean Tegner activity scores increased from 2.5 ( range , 2-5 ) to 5.9 ( range , 4-7 ) in the transtibial group and 2.3 ( range , 2-4 ) to 6.0 ( range , 3-8 ) in the tibial inlay group .
RESULTS	Twenty-one patients ( 58.3 % ) in the transtibial group and 19 patients ( 63.3 % ) in the tibial inlay group were able to return to preinjury sports activity .
RESULTS	In the posterior drawer test , 6 patients in the transtibial group and 4 patients in the tibial inlay group showed grade II laxity .
RESULTS	The mean side-to-side difference was 10.1 mm ( range , 7-12 mm ) in the transtibial group and 10.4 mm ( range , 9-13 mm ) in the tibial inlay group , improving postoperatively to 4.1 mm ( range , 0-8 mm ) and 4.2 mm ( range , 1-8 mm ) , respectively .
RESULTS	There was significant improvement between preoperative and final follow-up values .
RESULTS	However , there were no significant differences between the 2 groups in final follow-up outcomes .
RESULTS	Final follow-up radiographs showed that 6 patients ( 16.7 % ) in the transtibial group and 3 patients ( 10.0 % ) in the tibial inlay group were rated grade C according to International Knee Documentation Committee guidelines .
CONCLUSIONS	Clinical and radiographic outcomes between the 2 PCL reconstruction techniques were comparable .
CONCLUSIONS	Osteoarthritis was observed in patients , with a significant proportion presenting loss of joint space .
CONCLUSIONS	Examined factors , excluding meniscectomy , were not correlated with the development of osteoarthritis .

###24714660
OBJECTIVE	Vitamin D supplementation during pregnancy is a well-accepted recommendation worldwide ; however , the debate about the correct dose is ongoing .
OBJECTIVE	We aimed to compare daily doses of 600 , 1,200 , and 2,000 IU in this randomized , controlled study .
METHODS	The study group consisted of 91 pregnant women aged 16-42 years admitted to Kocaeli Maternity and Children Hospital between April 2011 and April 2012 .
METHODS	The participants were randomly divided into 3 groups .
METHODS	600 , 1,200 , and 2,000 IU/day of vitamin D was supplemented to group 1 ( control group , n = 31 ) , group 2 ( n = 31 ) , and group 3 ( n = 32 ) , respectively .
METHODS	Serum calcium , 25-hydroxyvitamin D ( 25OHD ) , and the calcium/creatinine ratio in spot urine samples were measured in the follow-up period .
METHODS	The serum calcium and 25OHD levels of the mothers ' infants were measured as well .
RESULTS	The frequency of vitamin D sufficiency after supplementation was 80 % in group 3 and it was significantly higher than in groups 1 ( 42 % ) and 2 ( 39 % ) ( p = 0.03 ) .
RESULTS	The frequency of vitamin D sufficiency in the infants of the participants was 91 % in group 3 and it was significantly higher than in groups 1 ( 36 % ) and 2 ( 52 % ) ( p = 0.006 ) .
CONCLUSIONS	At least 2,000 IU/day of vitamin D is needed to ensure adequate vitamin D status in pregnancy and early infancy .

###25252600
BACKGROUND	Microvascular obstruction ( MVO ) secondary to ischaemic-reperfusion injury is an important but underappreciated determinant of short - and longer-term outcome following percutaneous coronary intervention ( PCI ) treatment of ST-elevation myocardial infarction ( STEMI ) .
BACKGROUND	Several small studies have demonstrated a reduction in the degree of MVO utilising a variety of vasoactive agents , with adenosine and sodium nitroprusside ( SNP ) being most evaluated .
BACKGROUND	However , the evidence base remains weak as the trials have had variable endpoints , differing drug doses and delivery .
BACKGROUND	As such , the results regarding benefit are conflicting .
METHODS	The REperfusion Facilitated by LOcal adjunctive therapy in STEMI ( REFLO-STEMI ) trial is a multicentre , prospective , randomised , controlled , open label , study with blinded endpoint analysis : Patients presenting within 6 h of onset of STEMI and undergoing planned primary PCI ( P-PCI ) with TIMI 0/1 flow in the infarct-related artery ( IRA ) and no significant bystander coronary artery disease on angiography , are randomised into one of three groups : PCI with adjunctive pharmacotherapy ( intracoronary adenosine or SNP ) or control ( standard PCI ) .
METHODS	All receive Bivalirudin anticoagulation and thrombus aspiration .
METHODS	The primary outcome is infarct size ( IS ) ( determined as a percentage of total left ventricular mass ) measured by cardiac magnetic resonance imaging ( CMRI ) undertaken at 48 to 72 h post P-PCI .
METHODS	Secondary outcome measures include MVO ( hypoenhancement within infarct core ) on CMRI , angiographic markers of microvascular perfusion and MACE during 1-month follow-up .
METHODS	The study aims to recruit 240 patients ( powered at 80 % to detect a 5 % absolute reduction in IS ) .
CONCLUSIONS	The REFLO-STEMI study has been designed to address the weaknesses of previous trials , which have collectively failed to demonstrate whether adjunctive pharmacotherapy with adenosine and/or SNP can reduce measures of myocardial injury ( infarct size and MVO ) and improve clinical outcome , despite good basic evidence that they have the potential to attenuate this process .
CONCLUSIONS	The REFLO-STEMI study will be the most scientifically robust trial to date evaluating whether adjunctive therapy ( intracoronary adenosine or SNP following thrombus aspiration ) reduces CMRI measured IS and MVO in patients undergoing P-PCI within 6 h of onset of STEMI .
BACKGROUND	Trial registered 20th November 2012 : ClinicalTrials.gov Identifier NCT01747174 .

###26054138
OBJECTIVE	To compare the difference in the clinical efficacy on mild and moderate female stress urinary incontinence ( FSUI ) between transcutaneous acupoint electrical stimulation and oral administration of midodrine hydrochloride tablets .
METHODS	Ninety cases of mild and moderate FSUI were randomized into an observation group and a control group , 45 cases in each one .
METHODS	In the observation group , the transcutaneous acupoint electrical stimulation was applied to Ciliao ( BL 32 ) , Shenshu ( BL 23 ) , Zigong ( EX-CA 1 ) , Guanyuan ( CV 4 ) and Qihai ( CV 6 ) , once a day .
METHODS	In the control group , midodrine hydrochloride tablets were prescribed for oral administration , 2.5 mg per treatment , three times each day .
METHODS	The duration of treatment was 4 weeks .
METHODS	The score of international consultation on incontinence questionnaire-urinary incontinence short form ( ICI-Q-SF ) and leakage of urine in 1 h urinal pad test were observed before and after treatment in the patients of the two groups , and the efficacy was compared between the two groups .
RESULTS	The score of ICI-Q-SF and leakage of urine in urinal pad test after treatment were all improved apparently as compared with those before treatment in the two groups ( all P < 0.01 ) , and the results in the observation group were better than those in the control group ( both P < 0.01 ) .
RESULTS	The total effective rate was 86.7 % ( 39/45 ) in the observation group , which was better than 68.9 % ( 31/45 , P < 0.05 ) in the control group .
CONCLUSIONS	The transcutaneous acupoint electrical stimulation achieves the better efficacy on FSUI as compared with the oral administration of midodrine hydrochloride tablets .
CONCLUSIONS	This therapy effectively improves the patient 's urine control ability and reduces leakage of urine .

###25803256
OBJECTIVE	The aim of this study was to examine the level of compliance and persistence in patients with postmenopausal osteoporosis ( OP ) receiving daily risedronate ( 5 mg ) with either fixed dosing of three different timing regimens ( A : before breakfast ; B : in-between meals ; C : before bedtime ) or with flexible dosing and the effect on urinary N-terminal telopeptide of Type 1 collagen ( NTX-1 ) .
METHODS	The study included 448 patients with postmenopausal OP .
METHODS	Patients were randomly assigned into six treatment groups each with a permutation of the treatment sequence ( ABC , BCA , etc. ) in the crossover phase ( 3 x 1 week ) and randomized to 23 weeks of either the daily flexible ( either regimen A , B or C ) or fixed timing ( only regimen A , B , or C ) in the patient 's preference phase .
METHODS	Urinary NTX-1 was tested .
RESULTS	A total of 433 patients participated in the patient 's preference phase ( 49.7 % preferred flexible and 50.3 % fixed timing ) .
RESULTS	There was no significant difference between the proportion of responders who were both compliant and persistent in the flexible ( 54.4 % ) and fixed regimens ( 53.7 % ) ( p = 0.8803 ) .
RESULTS	A significant difference between the flexible and fixed regimens was seen in persistence in favor of the flexible regimen ( p = 0.0306 ) .
RESULTS	There was no significant difference between the flexible and fixed regimens in terms of compliance ( p = 0.4611 ) .
RESULTS	Change in urinary NTX-1 did not show any difference between the two regimens .
RESULTS	At the final visit , 51 % of patients in the flexible and 55 % in the fixed regimen group considered the used risedronate regimen as excellent or very good ( p = 0.1440 ) .
CONCLUSIONS	A flexible dosing with daily risedronate appears be a valuable option in terms of compliance and persistence for patients with postmenopausal OP .

###25931244
BACKGROUND	Treatment of complicated urinary-tract infections is challenging due to rising antimicrobial resistance .
BACKGROUND	We assessed the efficacy and safety of ceftolozane-tazobactam , a novel antibacterial with Gram-negative activity , in the treatment of patients with complicated lower-urinary-tract infections or pyelonephritis .
METHODS	ASPECT-cUTI was a randomised , double-blind , double-dummy , non-inferiority trial done in 209 centres in 25 countries .
METHODS	Between July , 2011 , and September , 2013 , hospital inpatients aged 18 years or older who had pyuria and a diagnosis of a complicated lower-urinary-tract infection or pyelonephritis were randomly assigned in a 1:1 ratio to receive intravenous 15 g ceftolozane-tazobactam every 8 h or intravenous high-dose ( 750 mg ) levofloxacin once daily for 7 days .
METHODS	The randomisation schedule was computer generated in blocks of four and stratified by study site .
METHODS	The next allocation was obtained by the study site pharmacist via an interactive voice-response system .
METHODS	The primary endpoint was a composite of microbiological eradication and clinical cure 5-9 days after treatment in the microbiological modified intention-to-treat ( MITT ) population , with a non-inferiority margin of 10 % .
METHODS	This study is registered with ClinicalTrials.gov , numbers NCT01345929 and NCT01345955 .
RESULTS	Of 1083 patients enrolled , 800 ( 739 % ) , of whom 656 ( 820 % ) had pyelonephritis , were included in the microbiological MITT population .
RESULTS	Ceftolozane-tazobactam was non-inferior to levofloxacin for composite cure ( 306 [ 769 % ] of 398 vs 275 [ 684 % ] of 402 , 95 % CI 23-146 ) and , as the lower bound of the two-sided 95 % CI around the treatment difference was positive and greater than zero , superiority was indicated .
RESULTS	Adverse event profiles were similar in the two treatment groups and were mainly non-serious .
CONCLUSIONS	Treatment with ceftolozane-tazobactam led to better responses than high-dose levofloxacin in patients with complicated lower-urinary-tract infections or pyelonephritis .
BACKGROUND	Cubist Pharmaceuticals .

###24370760
OBJECTIVE	The validity of the Talk Test ( TT ) is well documented , but the reliability of the test is not clear .
OBJECTIVE	The aim of this study was to assess the absolute and relative intertester reliability of the TT in cardiac patients .
METHODS	Cardiac patients ( n = 64 ) who had completed an exercise rehabilitation program were consecutively included in the study .
METHODS	Patients performed a submaximal ramp cycle ergometer test with the TT as intensity indicator .
METHODS	Every patient was tested twice on the same day by 2 different physiotherapists with a break of maximum 45 minutes between tests .
METHODS	Physiotherapists were randomized to tests .
METHODS	Workload in watts at the first negative stage of the TT was registered as the test result .
METHODS	Patients and physiotherapists were blinded to test results of the first test .
METHODS	Absolute reliability of the TT was assessed with Bland-Altman plot , standard error of measurement , and minimal detectable change .
METHODS	Relative reliability was assessed using the intraclass correlation coefficient ( ICC ) .
RESULTS	Mean difference in peak workload between test and retest was 0.8 W ( 95 % CI : -4.8 to 3.3 ) .
RESULTS	Limit of agreement was estimated to be +31 / -32 W. Standard error of measurement was 11 W ( 95 % CI : 10-14 ) , and minimal detectable change was 32 W.
RESULTS	The ICC was 0.85 ( 95 % CI : 0.78 to 0.91 ) .
CONCLUSIONS	Although the ICC was acceptable , we found a weak absolute intertester reliability of the TT and that the test is an insufficient measure to monitor exercise intensity and safety of cardiac patients when 2 or more physiotherapists may be administering the TT .

###25002002
BACKGROUND	Advances in information technology ( IT ) now permit population-based preventive screening , but the best methods remain uncertain .
BACKGROUND	We evaluated whether involving primary care providers ( PCPs ) in a visit-independent population management IT application led to more effective cancer screening .
METHODS	We conducted a cluster-randomized trial involving 18 primary care practice sites and 169 PCPs from June 15 , 2011 , to June 14 , 2012 .
METHODS	Participants included adults eligible for breast , cervical , and/or colorectal cancer screening .
METHODS	In practices randomized to the intervention group , PCPs reviewed real-time rosters of their patients overdue for screening and provided individualized contact ( via a letter , practice delegate , or patient navigator ) or deferred screening ( temporarily or permanently ) .
METHODS	In practices randomized to the comparison group , overdue patients were automatically sent reminder letters and transferred to practice delegate lists for follow-up .
METHODS	Intervention patients without PCP action within 8 weeks defaulted to the automated control version .
METHODS	The primary outcome was adjusted average cancer screening completion rates over 1-year follow-up , accounting for clustering by physician or practice .
RESULTS	Baseline cancer screening rates ( 80.8 % vs 80.3 % ) were similar among patients in the intervention ( n = 51,071 ) and comparison group ( n = 52,799 ) .
RESULTS	Most intervention providers used the IT application ( 88 of 101 , 87 % ) and users reviewed 7984 patients overdue for at least 1 cancer screening ( 73 % sent reminder letter , 6 % referred directly to a practice delegate or patient navigator , and 21 % deferred screening ) .
RESULTS	In addition , 6128 letters were automatically sent to patients in the intervention group ( total of 12,002 letters vs 16,378 letters in comparison practices ; P < .001 ) .
RESULTS	Adjusted average cancer screening rates did not differ among intervention and comparison practices for all cancers combined ( 81.6 % vs 81.4 % ; P = .84 ) nor breast ( 82.7 % vs 82.7 % ; P = .96 ) , cervical ( 84.1 % vs 84.7 % ; P = .60 ) , or colorectal cancer ( 77.8 % vs 76.2 % ; P = .33 ) .
CONCLUSIONS	Involving PCPs in a visit-independent population management IT application resulted in similar cancer screening rates compared with an automated reminder system , but fewer patients were sent reminder letters .
CONCLUSIONS	This suggests that PCPs were able to identify and exclude from contact patients who would have received automated reminder letters but not undergone screening .

###24385141
OBJECTIVE	Providing long-term follow-up of the natural history of age-related macular degeneration ( AMD ) and associated risk factors will facilitate future epidemiologic studies and clinical trials .
OBJECTIVE	To describe 10-year progression rates to intermediate or advanced AMD .
METHODS	We observed the Age-Related Eye Disease Study ( AREDS ) participants for an additional 5 years after a randomized clinical trial of antioxidant vitamins and minerals was completed .
METHODS	Observation occurred at 11 clinical sites of medical retinal practices from academic institutions and community medical centers .
METHODS	Participants aged 55 to 80 years with no AMD or AMD of varying severity ( n = 4757 ) were followed up in the AREDS trial for a median duration of 6.5 years .
METHODS	When the trial ended , 3549 of the 4203 surviving participants were followed for 5 additional years .
METHODS	Treatment with antioxidant vitamins and minerals .
METHODS	Development of varying stages of AMD and changes in visual acuity .
METHODS	The rates of progression to large drusen and advanced AMD ( neovascular AMD or central geographic atrophy ) were evaluated using annual fundus photographs assessed centrally .
METHODS	Best-corrected visual acuity was measured at annual study visits .
RESULTS	The risk of progression to advanced AMD increased with increasing age ( P = .01 ) and severity of drusen .
RESULTS	Women ( P = .005 ) and current smokers ( P < .001 ) were at increased risk of neovascular AMD .
RESULTS	In the oldest participants with the most severe AMD status at baseline , the risks of developing neovascular AMD and central geographic atrophy by 10 years were 48.1 % and 26.0 % , respectively .
RESULTS	Similarly , rates of progression to large drusen increased with increasing severity of drusen at baseline , with 70.9 % of participants with bilateral medium drusen progressing to large drusen and 13.8 % to advanced AMD in 10 years .
RESULTS	Median visual acuity at 10 years in eyes that had large drusen at baseline but never developed advanced AMD was 20/25 ; eyes that developed advanced AMD had a median visual acuity of 20/200 .
CONCLUSIONS	The natural history of AMD demonstrates relentless loss of vision in persons who developed advanced AMD .
CONCLUSIONS	These progression data and the risk factor analyses may be helpful to investigators conducting research in clinic populations .

###24556343
BACKGROUND	Non-alcoholic fatty liver disease ( NAFLD ) represents a range of liver conditions from simple fatty liver to progressive end stage liver disease requiring liver transplantation .
BACKGROUND	NAFLD is common in the population and in certain sub groups ( e.g. type 2 diabetes ) up to 70 % of patients may be affected .
BACKGROUND	NAFLD is not only a cause of end stage liver disease and hepatocellular carcinoma , but is also an independent risk factor for type 2 diabetes and cardiovascular disease .
BACKGROUND	Consequently , effective treatments for NAFLD are urgently needed .
OBJECTIVE	The WELCOME study is testing the hypothesis that treatment with high dose purified long chain omega-3 fatty acids will have a beneficial effect on a ) liver fat percentage and b ) two histologically validated algorithmically-derived biomarker scores for liver fibrosis .
METHODS	In a randomised double blind placebo controlled trial , 103 participants with NAFLD were randomised to 15-18months treatment with either 4g/day purified long chain omega-3 fatty acids ( Omacor ) or 4g/day olive oil as placebo .
METHODS	Erythrocyte percentage DHA and EPA enrichment ( a validated proxy for hepatic enrichment ) was determined by gas chromatography .
METHODS	Liver fat percentage was measured in three discrete liver zones by magnetic resonance spectroscopy ( MRS ) .
METHODS	We also measured body fat distribution , physical activity and a range of cardiometabolic risk factors .
METHODS	Recruitment started in January 2010 and ended in June 2011 .
METHODS	We identified 178 potential participants , and randomised 103 participants who met the inclusion criteria .
METHODS	The WELCOME study was approved by the local ethics committee ( REC : 08/H0502/165 ; www.clinicalTrials.gov registration number NCT00760513 ) .

###24279907
BACKGROUND	Nasya/Prevalin is a natural , drug-free nasal spray for treatment and prevention of allergic rhinitis .
BACKGROUND	Because of its thixotropic property , it forms a barrier on the nasal mucosa , preventing allergen contact .
BACKGROUND	This study assesses the clinical efficacy and safety of Nasya/Prevalin in a nasal provocation test with house dust mite allergens .
RESULTS	In this randomised , double-blind , placebo-controlled trial , 20 subjects suffering from allergic rhinitis because of house dust mite allergens received a single dose of Nasya/Prevalin or saline spray before allergen challenge .
RESULTS	Total nasal symptom score and total ocular symptom score were assessed 15 , 30 , 60 , 75 , 90 , 120 and 240min after challenge .
RESULTS	Further , the appearance of the mucosa was examined by rhinoscopy .
RESULTS	A single treatment with Nasya/Prevalin led to a significant reduction of TNSS at 60 , 75 and 90min after dust mite allergen challenge as compared with placebo ( pVCAS = 0.021 , pVCAS = 0.035 , pVCAS = 0.036 , respectively ) .
RESULTS	Mucosa changes assessed by the rhinoscopic score ( on swelling , secretion and colour ) were significantly worse in the placebo group compared with the Nasya/Prevalin group ( P = 0.033 ) .
RESULTS	Nasya/Prevalin was well tolerated , and the safety was comparable with placebo .
CONCLUSIONS	Treatment with Nasya/Prevalin was effective in preventing allergic reactions induced by dust mite allergen challenge .

###25335330
OBJECTIVE	To assess the efficacy of Yishen Jiejing Decoction ( YJD ) in treating poststroke shoulder-hand syndrome ( SHS ) patients of yin deficiency yang hyperactivity with blood stasis stagnation collaterals syndrome .
METHODS	Totally 60 SHS patients of yin deficiency yang hyperactivity with blood stasis stagnation collaterals syndrome were randomly assigned to two groups , the treatment group and the control group , 30 cases in each group .
METHODS	Conventional rehabilitation training and therapeutics were applied in all patients .
METHODS	Besides , patients in the treatment group took 50 mL YJD , twice a day .
METHODS	One month without interruption consisted of one course of treatment .
METHODS	The curative effects of each group were evaluated respectively before treatment and at one month after treatment .
METHODS	The neurologic impairment , TCM syndrome , and the improvement of upper limbs movement were assessed by the neurologic impairment integral , scoring for TCM syndrome diagnostics , Fugl-Meyer Assessment ( U-FMA ) .
METHODS	Adverse reactions were observed at the same time .
RESULTS	The effective rate of stroke was 86.67 % and the effective rate of SHS was 90.00 % in the treatment group , higher than those of the control group ( P < 0.05 ) .
RESULTS	Both groups got improvement in neurologic impairment , stroke induced blood stasis syndrome , yin deficiency yang hyperactivity syndrome , and the improvement of upper limbs movement after treatment ( all P < 0.05 ) .
RESULTS	Besides , all the improvement was obviously superior in the treatment group ( P < 0.05 ) .
RESULTS	No adverse reaction occurred during the course of treatment .
CONCLUSIONS	The curative effect of YJD combined with conventional rehabilitation training was confirmative and superior to the control group .

###24608228
OBJECTIVE	Polyphonic music ( music consisting of several instruments playing in parallel ) is an intuitive way of embedding multiple information streams .
OBJECTIVE	The different instruments in a musical piece form concurrent information streams that seamlessly integrate into a coherent and hedonistically appealing entity .
OBJECTIVE	Here , we explore polyphonic music as a novel stimulation approach for use in a brain-computer interface .
METHODS	In a multi-streamed oddball experiment , we had participants shift selective attention to one out of three different instruments in music audio clips .
METHODS	Each instrument formed an oddball stream with its own specific standard stimuli ( a repetitive musical pattern ) and oddballs ( deviating musical pattern ) .
RESULTS	Contrasting attended versus unattended instruments , ERP analysis shows subject - and instrument-specific responses including P300 and early auditory components .
RESULTS	The attended instrument can be classified offline with a mean accuracy of 91 % across 11 participants .
CONCLUSIONS	This is a proof of concept that attention paid to a particular instrument in polyphonic music can be inferred from ongoing EEG , a finding that is potentially relevant for both brain-computer interface and music research .

###24411424
BACKGROUND	Laparoscopic surgery requires certain specific skills .
BACKGROUND	There have been several attempts to minimize the learning curve with training outside the operation room .
BACKGROUND	Although simulators have been well validated as tools to teach technical skills , their integration into comprehensive curricula is lacking .
BACKGROUND	Several randomized controlled trials and systematic reviews have demonstrated that the technical skills learned on these simulators transfer to the operating room .
BACKGROUND	Currently , however , the integration of these simulated models into formal residency training curricula is lacking .
BACKGROUND	In our institute , we have adopted the Tuebingen Trainer devised by Professor GF Buess from Germany .
BACKGROUND	The purpose of this study was to evaluate the training of surgical residents on an ex vivo phantom model for basic laparoscopic skill acquisition and its transferability to the OR performance .
METHODS	Seventeen general surgery residents were randomized into 2 groups : Laparoscopic Training Group ( n = 9 , Group A ) and Standard Training Group ( n = 8 , Group B ) .
METHODS	Group A underwent training in the Minimally Invasive Surgery Training Centre on the porcine phantom model and did 10 laparoscopic cholecystectomies , whereas Group B did not undergo training in the Minimally Invasive Surgery Training Centre .
METHODS	All the participants performed a laparoscopic cholecystectomy in the operation theater in the presence of a consultant who was blinded to the training status of the participants .
METHODS	The performance of the residents in both groups in the operation theater was assessed using GOALS criteria , surgical performance assessment parameters , task-specific checklists , and visual analog scale for gallbladder perforation difficulty and overall competence .
RESULTS	The Laparoscopic Training Group had better performance than the Standard Training Group regarding operation time , GOALS criteria , and Task-specific checklists .
RESULTS	Although the surgical performance assessments , i.e. cystic duct and artery identification scores , gallbladder perforation scores , and liver injury scores , were better in the Laparoscopic Training Groups , they were not statistically significant .
RESULTS	The overall difficulty of the surgery was comparable in both the groups .
RESULTS	The Laparoscopic Training Group exhibited significant overall competence on visual analog scale scores .
CONCLUSIONS	Our study has clearly shown that training on the Tuebingen Trainer with integrated porcine organs results in a statistically significant improvement in the operating room performance of surgical residents as compared with the nontrained residents , thereby indicating a transfer of skills from training to the operating room .

###24304715
BACKGROUND	Physical activity during childhood and adolescence is associated with substantial health benefits and tracks into adulthood .
BACKGROUND	Nevertheless , only 22.7 % of German adolescents are sufficiently physically active .
BACKGROUND	Thus , the promotion of an active lifestyle in youth is an essential issue of public health.This study will evaluate the implementation and efficacy of the `` luft . ''
BACKGROUND	program to enhance physical activity in adolescence .
BACKGROUND	`` luft . ''
BACKGROUND	is a multicomponent school-based program developed on the basis of effective strategies for health interventions and behavioral change .
METHODS	The `` luft . ''
METHODS	physical activity program targets four different levels .
METHODS	( a ) Each student receives a pedometer and documents his/her steps over 12 weeks using an interactive user account on the `` luft . ''
METHODS	homepage .
METHODS	( b ) For classes there will be different competitions , with achieving the most steps in selected weeks , the highest increases of steps and developing the most inventive ideas to promote physical activity in school .
METHODS	Besides , the intervention includes four educational lessons .
METHODS	( c ) The headmasters and teaching staff of the participating schools will get information material with suggestions and encouragement to enhance physical activity in school .
METHODS	Participating teachers will be invited to an introductory seminar .
METHODS	( d ) Parents will be provided with informational material about the program and will be invited to a parent-teacher conference about the benefits of being physically active and how they can support their children in engaging in a physically active lifestyle.To evaluate the efficacy of the `` luft . ''
METHODS	physical activity program , a two-arm cluster randomized controlled trial will be conducted in three waves : ( 1 ) baseline assessment , January/February 2014 , ( 2 ) post assessment , June/July 2014 and ( 3 ) 12-month follow-up assessment , June/July 2015 .
METHODS	Data collection will include physical and medical testing , self-administered questionnaires , group discussions and document analyses .
CONCLUSIONS	`` luft . ''
CONCLUSIONS	aims at fostering a physically active lifestyle in adolescence while a considerable decline of physical activity is present .
CONCLUSIONS	Physical activity programs based in the school setting and following a multicomponent approach have been proven to be most successful .
CONCLUSIONS	Furthermore , the use of pedometers is promising to enhance physical activity during the entire day and targets a wide range of adolescents regarding fitness and weight .
BACKGROUND	Current Controlled Trials ISRCTN49482118 .

###25609940
BACKGROUND	Glycopyrronium is a once-daily ( od ) long-acting muscarinic antagonist for the maintenance treatment of chronic obstructive pulmonary disease ( COPD ) .
BACKGROUND	The GLOW7 study evaluated the efficacy and safety of od glycopyrronium 50 g in predominantly Chinese patients with moderate-to-severe COPD .
METHODS	In this 26-week , multi-center , double-blind , placebo-controlled , parallel-group study , men and women 40 years with moderate-to-severe COPD were randomized to glycopyrronium 50 g od or placebo ( 2:1 ) .
METHODS	The primary objective was to confirm the significant improvement of trough forced expiratory volume in 1 second ( FEV1 ) following 12 weeks of treatment with glycopyrronium compared with placebo .
METHODS	Secondary objectives included the effect of glycopyrronium on health status ( St George 's Respiratory Questionnaire ) , breathlessness ( Transition Dyspnea Index ) , other lung function parameters , rescue medication use , and COPD exacerbations .
METHODS	Safety and tolerability were also evaluated .
RESULTS	Of the 460 patients randomized , 459 were included in the full analysis set ( glycopyrronium , n = 306 ; placebo , n = 154 ; mean age 64.7 years ; mean post-bronchodilator FEV1 : 50.8 % predicted ) ; 425 ( 92.4 % ) completed the study .
RESULTS	At Week 12 , glycopyrronium signifcantly improved trough FEV1 with a least square means treatment difference of 141 mL ( 95 % confidence interval 111 mL , 171 mL ; P < 0.001 ) compared with placebo .
RESULTS	The mean treatment effect of glycopyrronium was greater than the minimum clinically important difference versus placebo in both St George 's Respiratory Questionnaire total score ( -4.92 ; P < 0.001 ) and Transition Dyspnea Index focal score ( 1.0 ; P < 0.001 ) at week 26 .
RESULTS	Glycopyrronium reduced the risk of exacerbations in terms of time to first moderate or severe exacerbation by 28 % ( P = 0.153 ) and rate of moderate or severe COPD exacerbation by 29 % ( P = 0.119 ) compared with placebo .
RESULTS	Incidence of death was 1.3 % with glycopyrronium and 0 % in placebo during the treatment period .
RESULTS	Overall incidence of adverse events ( glycopyrronium 43.6 % ; placebo 47.4 % ) and serious adverse events ( glycopyrronium 5.6 % ; placebo 9.1 % ) were similar .
CONCLUSIONS	In predominantly Chinese patients with moderate-to-severe COPD , od glycopyrronium 50 g significantly improved lung function , dyspnea , and health status compared with placebo .
CONCLUSIONS	The safety and tolerability profile of glycopyrronium was comparable to placebo .

###24509120
OBJECTIVE	Blood pressure normally declines during the night ( ` dipping ' ) ; a blunted nocturnal decline is an important cardiovascular risk factor .
OBJECTIVE	Marriage may be associated with lower ambulatory blood pressure , although this may be confounded by socio-economic and dietary factors .
OBJECTIVE	We examined the association of marital status with nocturnal dipping and night-time SBP amongst individuals on a controlled diet .
METHODS	We analysed 325 individuals enrolled in the Dietary Approaches to Stop Hypertension trial who had available 24-h SBP data and who ingested a control diet .
METHODS	Logistic and linear regression models were fit to estimate the association of marital status with nocturnal dipping and mean night-time SBP .
RESULTS	Of the 325 individuals , 52.9 % were men , the average age was 45.1 years and 48.9 % reported being married .
RESULTS	Compared with nonmarried individuals , those who were married had greater adjusted odds of dipping [ odds ratio ( OR ) 2.26 ; 95 % confidence interval ( CI ) 1.26-4 .03 ; P = 0.01 ] .
RESULTS	In adjusted models , being married was associated with lower night-time SBP ( -2.4 mmHg ; 95 % CI -3.8 to -0.9 mmHg ; P = 0.002 ) , with the suggestion of a greater association in married men compared with married women ( -3.1 vs. -1.7 mmHg ) ; there was less difference for married nonblacks compared with married blacks ( -2.7 and -2.4 mmHg , respectively ) .
CONCLUSIONS	Being married is independently associated with a greater likelihood of nocturnal dipping and with lower night-time SBP among individuals participating in a controlled dietary intervention ; the association was particularly strong in married men .
CONCLUSIONS	Marital status is a variable that may be considered in future analyses of ambulatory blood pressure .

###24220487
OBJECTIVE	This study aimed to determine if preoperative oral administration of metoclopramide , chlorpromazine , gabapentin , or dexamethasone would effectively reduce postoperative nausea and vomiting ( PONV ) in the first 24 hours after surgery in patients undergoing maxillofacial trauma surgery .
METHODS	One hundred fifty patients with maxillofacial skeletal trauma that need open reduction and internal fixation were randomly assigned to receive one of the following drugs orally , 1 hour preoperative : 10 mg metoclopramide ( group A ) , 300 mg gabapentin ( group B ) , 100 mg chlorpromazine ( group C ) , 5 mg dexamethasone ( group D ) , and placebo ( group E ) .
METHODS	All patients were observed in the first 24 hours for PONV .
METHODS	Data analysis was done with the SPSS software ( version 19 ) , using chi-square test , Fisher exact test , and multiple logistic regression methods .
RESULTS	The incidence of vomiting was significantly lower in groups A ( 2/30 ) , B ( 3/30 ) , and C ( 2/30 ) compared with the placebo group ( 9/30 ) ( P < 0.05 ) .
RESULTS	Also , the incidence of postoperative nausea was significantly high in the placebo group ( 11/30 ) as compared to treatment groups A ( 2/30 ) , B ( 3/30 ) , and C ( 3/30 ) ( P < 0.05 ) .
RESULTS	No significant differences in the incidence of PONV were found between groups D ( 7/30 ) and E ( P > 0.05 ) .
RESULTS	Of all demographic variables , anesthesia time ( P = 0.034 ) and surgery time ( P = 0.047 ) were predictors of PONV .
CONCLUSIONS	Our results demonstrated that premedication with oral metoclopramide , gabapentin , or chlorpromazine can significantly decrease the incidence of PONV in patients undergoing maxillofacial trauma surgery .

###24457632
BACKGROUND	To understand whether combination antiretroviral therapy ( cART ) has been optimized , we asked whether 3-drug protease inhibitor ( PI ) - based cART intensified with raltegravir and maraviroc and initiated during early infection would improve outcomes when compared with similarly applied 3-drug PI-based cART .
METHODS	Forty newly HIV-1-infected patients were randomized 1:2 to receive 3-drug ( N = 14 ) or 5-drug ( N = 26 ) therapy .
METHODS	The primary end point was the percent of subjects with undetectable plasma viremia using standard reverse transcriptase-polymerase chain reaction and the single copy assay after 48 weeks .
METHODS	Secondary end points included levels of cell-associated HIV-1 DNA and RNA and levels of infectious virus in resting CD4 T cells at week 96 and quantitative and qualitative immunologic responses .
RESULTS	At 48 weeks , 34 subjects remained on study and are included in the as-treated analysis .
RESULTS	Three of 11 ( 27.3 % ) in the 3-drug arm and 9 of 21 ( 42.9 % ) in the 5-drug arm had plasma HIV-1 RNA levels below detection by both standard reverse transcriptase-polymerase chain reaction and single copy assay ( P = 0.46 , Fisher exact test ) .
RESULTS	No significant differences in absolute levels of proviral DNA or changes in cell-associated RNA were seen during 96 weeks of therapy .
RESULTS	Mean levels of infectious HIV-1 in resting CD4 T cells at week 96 in 7 subjects treated with 3-drugs and 13 with 5-drugs were 0.67 and 0.71 infectious units per million , respectively ( P = 0.81 ) .
RESULTS	No differences were seen in quantitative or qualitative immunologic determinations including markers of immune activation .
CONCLUSIONS	Intensified 5-drug cART initiated during early infection fails to significantly further impact virologic or immunologic responses beyond those achieved with standard 3-drug PI-based cART .

###25492571
BACKGROUND	To investigate the effects of different target plasma remifentanil concentrations on the minimum alveolar concentration of sevoflurane ( MAC ) for blocking adrenergic response ( BAR ) during laparoscopic gynaecological surgery with carbon dioxide insufflation .
METHODS	Seventy-five gynaecological patients with ASA I-II undergoing laparoscopic surgery were randomly assigned to three groups .
METHODS	Anaesthesia was induced by sevoflurane , and 0.1 mg kg ( -1 ) of vecuronium i.v. was injected to facilitate tracheal intubation .
METHODS	After intubation the target plasma concentrations of remifentanil in Groups 1 , 2 , and 3 were adjusted to 0 , 1 , and 2 ng ml ( -1 ) , respectively .
METHODS	The changes in haemodynamics were observed before and after the creation of carbon dioxide pneumoperitoneum .
METHODS	The MAC BAR of sevoflurane in each group was determined by using an up-and-down sequential-allocation technique , and blood samples were collected at corresponding time points to determine the concentrations of remifentanil , norepinephrine , and epinephrine .
RESULTS	In Groups 1 , 2 and 3 , the MAC BAR of sevoflurane was 4.6 % ( CI 95 % : 4.3-4 .9 % ) , 2.4 % ( CI 95 % : 2.2-2 .6 % ) , and 1.7 % ( CI 95 % : 1.4-2 .1 % ) , respectively .
RESULTS	No significant differences were found in the increase of norepinephrine , epinephrine , and mean arterial pressure after compared with before insufflation of pneumoperitoneum among the three groups .
CONCLUSIONS	Remifentanil can effectively decrease the sevoflurane concentration to block sympathetic adrenergic response to CO2 pneumoperitoneum stimulus .
CONCLUSIONS	At similar MAC BAR the haemodynamic and adrenergic response is not affected by the infused remifentanil concentration .
BACKGROUND	The number of this clinical trial registry is ChiCTR-TRC-13004005 , and the Universal Trial Number is U1111-1151-5630 .

###25607117
BACKGROUND	Anesthesiologists use various medications to provide surgical patients with pain relief in the postoperative period .
BACKGROUND	Other modalities , such as music , could be used in conjunction with opioids and nonsteroidal anti-inflammatory drugs ( NSAIDs ) to decrease pain and lower heart rate and blood pressure .
BACKGROUND	Our hypothesis was that patients listening to jazz in a postanesthesia care unit ( PACU ) would have lower heart rates and blood pressures and reduced pain and anxiety .
OBJECTIVE	The study objective was to determine if listening to jazz music in the PACU , when compared to wearing noise-canceling headphones with no music playing , would decrease heart rate , blood pressure , pain , or anxiety in patients undergoing a hysterectomy .
METHODS	The research design was a prospective , randomized study .
METHODS	The study was conducted in the PACU at the Penn State Hershey Medical Center in Hershey , PA , USA .
METHODS	A total of 56 patients , aged 18-75 y , who were categorized as status 1 or 2 according to the American Society of Anesthesiologists ( ASA ) Physical Status Classification System , and who were undergoing elective laparoscopic or abdominal hysterectomies , were enrolled in the study .
METHODS	Patients were randomly assigned either to listen to jazz music where the beats per min ( BPM ) was < 100 ( experimental group , n = 28 ) or to wear noise-canceling headphones ( control group , n = 28 ) for 30 min while in the PACU after their surgery .
METHODS	Heart rate was the primary outcome , and secondary outcomes included systolic and diastolic blood pressure , an anxiety score , and a pain score .
METHODS	All outcome measures were initially recorded at baseline upon the patient 's arrival in the PACU .
METHODS	Heart rate and blood pressure were recorded postoperatively every 5 min for the initial 30 min that a patient was in the PACU .
METHODS	Pain was checked every 10 min during the 30-min period ; anxiety was checked at 30 min .
RESULTS	Heart rates of patients in the noise-cancellation group were significantly lower when compared with baseline ( P < .05 ) , at all time points .
RESULTS	For patients in the jazz group , heart rates were significantly lower at 15 , 20 , 25 , and 30 min when compared with baseline .
RESULTS	The pain scores were significantly lower ( P < .05 ) in the noise-cancellation group compared with the jazz group at 10 min into the recovery period .
CONCLUSIONS	Overall , the results showed that patients responded not only to music but also to silence in the PACU .
CONCLUSIONS	Using music and/or noise reduction could decrease opioid administration , promote relaxation , and improve patient satisfaction .

###24768476
BACKGROUND	Cold Water Immersion ( CWI ) is commonly used to manage delayed onset muscle soreness ( DOMS ) resulting from exercise .
BACKGROUND	Scientific evidence for an optimal dose of CWI is lacking and athletes continue to use a range of a treatment protocols and water temperatures .
OBJECTIVE	To compare the effectiveness of four different water immersion protocols and a passive control intervention in the management of DOMS .
METHODS	Randomised controlled trial with blinded outcome assessment .
METHODS	University Research Laboratory .
METHODS	50 healthy participants with laboratory induced DOMS randomised to one of five groups : Short contrast immersion ( 1min 38C/1min 10C3 ) , Short intermittent CWI ( 1min3 at 10C ) ; 10min CWI in 10C ; 10min CWI in 6C ; or control ( seated rest ) .
METHODS	muscle soreness , active range of motion , pain on stretch , muscle strength and serum creatine kinase .
RESULTS	10min of CWI in 6C was associated with the lowest levels of muscle soreness and pain on stretch however values were not statistically different to any of the other groups .
RESULTS	There were no statistically significant differences between groups for any other outcomes .
CONCLUSIONS	Altering the treatment duration , water temperature or dosage of post exercise water immersion had minimal effect on outcomes relating to DOMS .

###24535455
BACKGROUND	The aim of this study was to investigate the efficacy of rikkunshito ( RKT ) , a traditional Japanese medicine , combined with proton pump inhibitor ( PPI ) in patients with PPI-refractory non-erosive reflux disease ( NERD ) .
METHODS	Patients with PPI-refractory NERD ( n = 242 ) were randomly assigned to the RKT group [ rabeprazole ( 10 mg/day ) + RKT ( 7.5 g/t .
METHODS	i.d. ) for 8 weeks ] or the placebo group ( rabeprazole + placebo ) .
METHODS	After the 4 - and 8-week treatments , we assessed symptoms and quality of life ( QOL ) using the Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease ( FSSG ) , Gastrointestinal Symptom Rating Scale ( GSRS ) , and Short-Form Health Survey-8 ( SF-8 ) .
RESULTS	There were no significant differences in FSSG and GSRS score improvement between these groups after the 4 - and 8-week treatments .
RESULTS	The mental component summary ( MCS ) scores of the SF-8 improved more in the RKT group ( from 45.8 8.1 to 48.5 7.4 ) than in the placebo group ( from 47.7 7.1 to 48.4 7.5 ) after the 4-week treatment ( P < 0.05 ) .
RESULTS	The 8-week treatment with RKT was more effective for improvement of the degree of MCS score in patients with a low body mass index ( < 22 ) ( P < 0.05 ) and significantly improved the acid-related dysmotility symptoms of FSSG in female and elderly patients ( 65 years ) .
CONCLUSIONS	There were no significant differences in improvement of GERD symptoms in patients with PPI-refractory NERD between these groups .
CONCLUSIONS	However , RKT may be useful for improving mental QOL in non-obese patients and acid-related dyspeptic symptoms , especially in women and the elderly .

###25248944
BACKGROUND	Beta-adrenergic blockade has been shown to improve left ventricular function , reduce hospital admissions and improve survival in chronic heart failure with reduced ejection fraction ( HFrEF ) , with mortality reduction starting early after beta-adrenergic receptor blocker initiation and being dose-related .
BACKGROUND	The aim of this pilot study was to determine the effectiveness of a nurse-led titration clinic in improving the time required for patients to reach optimal doses of the beta-adrenergic receptor blocking agents .
METHODS	We conducted a prospective pilot randomized controlled trial .
METHODS	Twenty eight patients with CHF were randomized to optimisation of beta-adrenergic receptor blocker therapy over six months by either a nurse-led titration ( NLT ) clinic , led by a nurse specialist with the support of a cardiologist in a CHF clinic , or by their primary care physician ( usual care ( UC ) ) .
METHODS	The primary endpoint was time to maximal beta-adrenergic receptor blocker dose .
METHODS	The secondary end-point was the proportion of patients reaching the target dose of beta-adrenergic receptor blocker by six months .
RESULTS	The patients were predominantly men ( 72 % ) , age 67 16 years ; New York Heart Association ( NYHA ) functional class I ( 32 % ) , II ( 44 % ) and III ( 20 % ) ; baseline left ventricular ejection fraction 33 10 % , and a low mean Charlson co-morbidity score of 2.5 1.4 .
RESULTS	The time to maximum dose was shorter in the NLT group compared to the UC group ( 90 14 vs 166 8 days , p < 0.0005 ) .
RESULTS	At six months , in the NLT group there were nine patients ( 82 % ) on high dose and one patient ( 9 % ) on low dose beta-adrenergic receptor blocker compared to the UC group with five ( 42 % ) patients reaching maximum dose and five ( 42 % ) patients on low dose ( p = 0.04 ) .
RESULTS	The patients allocated to the NLT group also had significantly less worsening of depression between baseline and six months ( p = 0.006 ) .
CONCLUSIONS	A NLT clinic improves optimisation of beta-adrenergic receptor blocker therapy through increasing the proportion of patients reaching maximal dose and facilitating rapid up-titration of beta-adrenergic receptor blocker agents in patients with chronic HFrEF .
BACKGROUND	Australian Clinical Trials Registry ( ACTRN012606000383561 ) .

###25148234
BACKGROUND	Recombinant leptin ( metreleptin ) treatment restores bone mineral density in women with hypothalamic amenorrhea ( HA ) , a condition characterized by hypoleptinemia , which has adverse impact on bone health .
OBJECTIVE	The objective of the study was to investigate how metreleptin exerts its positive effect on bone metabolism in humans .
METHODS	This was a randomized , double-blinded , placebo-controlled study .
METHODS	The study was conducted at Beth Israel Deaconess Medical Center ( Boston , Massachusetts ) .
METHODS	Women ( n = 18 ) with HA and hypoleptinemia for at least 6 months were randomized to receive either metreleptin or placebo for 36 weeks .
METHODS	Serum samples were obtained at baseline and 12 , 24 , and 36 weeks of treatment .
METHODS	Circulating levels of leptin , intact PTH ( iPTH ) , receptor activator of nuclear factor-B ligand ( RANKL ) , osteoprotegerin ( OPG ) , sclerostin , dickkopf-1 , and fibroblast growth factor-23 .
RESULTS	Metreleptin administration significantly increased leptin levels throughout the treatment period ( P = .001 ) .
RESULTS	iPTH decreased over the 36 weeks of treatment ( P = .01 ) .
RESULTS	There was a trend toward a decrease in serum RANKL and increase in serum OPG in the metreleptin-treated group .
RESULTS	The RANKL to OPG ratio was significantly decreased within the metreleptin ( P = .04 ) but not the placebo group .
RESULTS	Metreleptin had no effect on serum sclerostin , dickkopf-1 , and fibroblast growth factor-23 .
CONCLUSIONS	Metreleptin treatment over 36 weeks decreases iPTH and RANKL to OPG ratio levels in hypoleptinemic women with HA .

###24612097
OBJECTIVE	We have previously found that sarcosine , a glycine transporter I inhibitor , can improve the psychiatric symptoms of schizophrenia .
OBJECTIVE	In this study , we aimed to investigate whether the agent can also ameliorate neuropsychiatric symptoms of Parkinson 's disease ( PD ) patients with dementia .
METHODS	An 8-week , double-blind , placebo-controlled trial was conducted in patients who had PD with dementia ( PD-D ) .
METHODS	Neuropsychiatric manifestations were measured before and at week 2 ( V1 ) , week 4 ( V2 ) and week 8 ( V3 ) after treatment .
METHODS	Linear regression with the generalized estimating equations was applied for data analysis .
RESULTS	Fifteen patients were randomized into a sarcosine group ; the other 15 into a placebo group .
RESULTS	The generalized estimating equations model revealed significant differences in Hamilton Depression Rating Scale score ( P = 0.049 ) at V1 and Neuropsychiatry Inventory ( P = 0.039 ) at V2 between the treatment and placebo groups .
RESULTS	By excluding the advanced patients from analysis , there were significant differences in Unified Parkinson 's Disease Rating Scale V2 ( P = 0.004 ) and V3 ( P = 0.040 ) , Hamilton Depression Rating Scale V1 ( P = 0.014 ) and V2 ( P = 0.047 ) , Neuropsychiatry Inventory V1 ( P = 0.002 ) and V2 ( P < 0.001 ) and Behavior Pathology in Alzheimer 's Disease Rating Scale V2 ( P = 0.025 ) in favor of sarcosine .
CONCLUSIONS	Sarcosine temporally improved depression and neuropsychiatric symptoms in PD-D patients without exacerbating the motor or cognitive features ; the beneficial effects were more prominent in patients with mild-moderate severity .
CONCLUSIONS	Enhancement of N-methyl-D-aspartate receptor-glycine cascade may lead to a novel path for the management of PD-D .

###25974971
OBJECTIVE	To compare the astigmatic outcomes of LASIK with a single excimer laser platform using either wavefront-guided ( WFG ) or wavefront-optimized ( WFO ) modes .
METHODS	Sixty-eight eyes of 34 patients underwent LASIK for myopia with the Wavelight Allegretto Eye-Q 400-Hz laser platform ( Alcon Laboratories , Inc. , Henberg , Switzerland ) .
METHODS	One eye underwent WFG-LASIK and the contralateral eye underwent WFO-LASIK .
METHODS	Alpins vector analysis of astigmatism was performed using manifest refraction measured preoperatively and 12 months postoperatively and vertexed to the corneal plane .
METHODS	Eyes were stratified for subgroup analysis based on preoperative manifest astigmatism .
RESULTS	WFG-LASIK and WFO-LASIK were similar with regard to surgically induced astigmatism , difference vector , magnitude of error , correction index , flattening index , and index of success .
RESULTS	The angle of error was 80 % less in the WFG group compared to the WFO group ( 1.92 0.67 vs 9.66 3.7 , P = .04 ) .
CONCLUSIONS	WFG-LASIK and WFO-LASIK using the Alcon WaveLight Allegretto Eye-Q 400-Hz excimer laser platform produce similar astigmatic results in myopic patients ; however , the WFG mode may produce slightly more predictable astigmatic corrections .

###24733799
OBJECTIVE	Painful oral mucositis ( OM ) is a significant toxicity during radiotherapy for head and neck cancers .
OBJECTIVE	The aim of this randomized , double-blind , placebo-controlled trial was to test the efficacy of doxepin hydrochloride in the reduction of radiotherapy-induced OM pain .
METHODS	In all , 155 patients were randomly allocated to a doxepin oral rinse or a placebo for the treatment of radiotherapy-related OM pain .
METHODS	Patients received a single dose of doxepin or placebo on day 1 and then crossed over to receive the opposite agent on a subsequent day .
METHODS	Pain questionnaires were administered at baseline and at 5 , 15 , 30 , 60 , 120 , and 240 minutes .
METHODS	Patients were then given the option to continue doxepin .
METHODS	The primary end point was pain reduction as measured by the area under the curve ( AUC ) of the pain scale using data from day 1 .
RESULTS	Primary end point analysis revealed that the AUC for mouth and throat pain reduction was greater for doxepin ( -9.1 ) than for placebo ( -4.7 ; P < .001 ) .
RESULTS	Crossover analysis of patients completing both phases confirmed that patients experienced greater mouth and throat pain reduction with doxepin ( intrapatient changes of 4.1 for doxepin-placebo arm and -2.8 for placebo-doxepin arm ; P < .001 ) .
RESULTS	Doxepin was associated with more stinging or burning , unpleasant taste , and greater drowsiness than the placebo rinse .
RESULTS	More patients receiving doxepin expressed a desire to continue treatment than did patients with placebo after completion of each of the randomized phases of the study .
CONCLUSIONS	A doxepin rinse diminishes OM pain .
CONCLUSIONS	Further studies are warranted to determine its role in the management of OM .

###24508492
BACKGROUND	Biomarkers may contribute to risk stratification in coronary heart disease ( CHD ) .
BACKGROUND	We examined whether plasma midregional proadrenomedullin ( MR-proADM ) concentration at baseline and its change over one year predicts long-term outcomes in stable CHD patients .
METHODS	The LIPID study randomised patients 3-36 months after an acute coronary syndrome with total cholesterol 4.0-7 .0 mmol/L ( 155-271 mg/dL ) , to placebo or pravastatin 40 mg .
METHODS	Follow-up was 6.0 years .
METHODS	MR-proADM plasma concentrations at baseline and one year later were determined in 7863 and 6658 patients , respectively .
METHODS	These were categorised into quartiles to perform Cox regression analysis , adjusting for baseline parameters .
RESULTS	Baseline MR-proADM concentrations predicted major CHD events ( non-fatal myocardial infarction or CHD death ; hazard ratio ( HR ) 1.52 , 1.26-1 .84 for Q4-Q1 ) , CHD death ( HR 2.21 , 1.67-2 .92 ) , heart failure ( HR 2.30 , 1.78-2 .97 ) and all-cause mortality ( HR 1.82 , 1.49-2 .23 ) .
RESULTS	Associations were still significant after adjustment for baseline B-type natriuretic peptide ( BNP ) concentration .
RESULTS	Increase in MR-proADM after one year was associated with increased risk of subsequent CHD events ( HR 1.34 , 1.08-1 .66 ) , non-fatal myocardial infarction ( HR 1.50 , 1.12-2 .03 ) , heart failure ( HR 1.78 , 1.37-2 .30 ) and all-cause mortality ( HR 1.31 , 1.04-1 .64 ) .
RESULTS	Associations with heart failure and all-cause mortality remained significant after adjusting for baseline and change in BNP concentration .
RESULTS	Change in MR-proADM moderately improved risk reclassification for major CHD events ( net reclassification improvement ( NRI ) 3.48 % ) but strongly improved risk reclassification for heart failure ( NRI 5.60 % ) .
CONCLUSIONS	Baseline and change in MR-proADM concentrations over one year are associated with risk of major clinical events , even after adjustment for BNP concentrations .

###25495887
BACKGROUND	Developing efficacious medications to treat methamphetamine dependence is a global challenge in public health .
BACKGROUND	Topiramate ( TPM ) is undergoing evaluation for this indication .
BACKGROUND	The molecular mechanisms underlying its effects are largely unknown .
BACKGROUND	Examining the effects of TPM on genome-wide gene expression in methamphetamine addicts is a clinically and scientifically important component of understanding its therapeutic profile .
METHODS	In this double-blind , placebo-controlled clinical trial , 140 individuals who met the DSM-IV criteria for methamphetamine dependence were randomized to receive either TPM or placebo , of whom 99 consented to participate in our genome-wide expression study .
METHODS	The RNA samples were collected from whole blood for 50 TPM - and 49 placebo-treated participants at three time points : baseline and the ends of weeks 8 and 12 .
METHODS	Genome-wide expression profiles and pathways of the two groups were compared for the responders and non-responders at Weeks 8 and 12 .
METHODS	To minimize individual variations , expression of all examined genes at Weeks 8 and 12 were normalized to the values at baseline prior to identification of differentially expressed genes and pathways .
RESULTS	At the single-gene level , we identified 1054 , 502 , 204 , and 404 genes at nominal P values < 0.01 in the responders vs. non-responders at Weeks 8 and 12 for the TPM and placebo groups , respectively .
RESULTS	Among them , expression of 159 , 38 , 2 , and 21 genes was still significantly different after Bonferroni corrections for multiple testing .
RESULTS	Many of these genes , such as GRINA , PRKACA , PRKCI , SNAP23 , and TRAK2 , which are involved in glutamate receptor and GABA receptor signaling , are direct targets for TPM .
RESULTS	In contrast , no TPM drug targets were identified in the 38 significant genes for the Week 8 placebo group .
RESULTS	Pathway analyses based on nominally significant genes revealed 27 enriched pathways shared by the Weeks 8 and 12 TPM groups .
RESULTS	These pathways are involved in relevant physiological functions such as neuronal function/synaptic plasticity , signal transduction , cardiovascular function , and inflammation/immune function .
CONCLUSIONS	Topiramate treatment of methamphetamine addicts significantly modulates the expression of genes involved in multiple biological processes underlying addiction behavior and other physiological functions .

###25403238
BACKGROUND	We explored psychometric properties of the Osteoporosis Assessment Questionnaire 2.0 in terms of reliability , validity , and responsiveness with generic , clinical , demographic , and preference-based data collected from a population of postmenopausal women with osteoporosis .
METHODS	The Multiple Outcomes of Raloxifene Evaluation study was a randomized , placebo-controlled , multinational clinical trial evaluating efficacy and safety of raloxifene .
METHODS	The Osteoporosis Assessment Questionnaire 2.0 , a generic quality of life measure ( Nottingham Health Profile ) , and a preference-based measure ( Health Utilities Index ) were administered at baseline and annually .
METHODS	Psychometric properties of the 14 Osteoporosis Assessment Questionnaire 2.0 domains were evaluated by standard statistical techniques .
RESULTS	This study included a subset of 1477 women from the Multiple Outcomes of Raloxifene Evaluation study population completing the questionnaires .
RESULTS	Mean ( standard deviation ) age was 68.4 ( 6.8 ) years .
RESULTS	Prevalent vertebral fractures were found in 70 % ( n = 1038 ) of women .
RESULTS	Internal consistency was > 0.7 in 9 Osteoporosis Assessment Questionnaire 2.0 domains .
RESULTS	Correlations were moderate and significant for similar Osteoporosis Assessment Questionnaire 2.0 domain scores , Nottingham Health Profile domains , and Health Utilities Index scores .
RESULTS	All but 2 Osteoporosis Assessment Questionnaire 2.0 domains distinguished between patients with or without prevalent vertebral fractures and detected worsening with increased number of vertebral fractures .
RESULTS	Women with 1 incident vertebral fracture generally had a greater worsening in Osteoporosis Assessment Questionnaire 2.0 scores ( excluding social activity and support of family and friends ) from baseline to study endpoint compared with women without incident vertebral fractures .
CONCLUSIONS	Most domains in the Osteoporosis Assessment Questionnaire 2.0 demonstrated robust psychometric properties ; however , several domains not showing these criteria may need to be reassessed and removed for a potentially shorter and validated version of the Osteoporosis Assessment Questionnaire .

###24597534
BACKGROUND	There is growing evidence suggesting that prolonged sitting has negative effects on people 's weight , chronic diseases and mortality .
BACKGROUND	Interventions to reduce sedentary time can be an effective strategy to increase daily energy expenditure .
BACKGROUND	The purpose of this study is to evaluate the effectiveness of a six-month primary care intervention to reduce daily of sitting time in overweight and mild obese sedentary patients .
METHODS	The study is a randomized controlled trial ( RCT ) .
METHODS	Professionals from thirteen primary health care centers ( PHC ) will randomly invite to participate mild obese or overweight patients of both gender , aged between 25 and 65 years old , who spend 6 hours at least daily sitting .
METHODS	A total of 232 subjects will be randomly allocated to an intervention ( IG ) and control group ( CG ) ( 116 individuals each group ) .
METHODS	In addition , 50 subjects with fibromyalgia will be included.Primary outcome is : ( 1 ) sitting time using the activPAL device and the Marshall questionnaire .
METHODS	The following parameters will be also assessed : ( 2 ) sitting time in work place ( Occupational Sitting and Physical Activity Questionnaire ) , ( 3 ) health-related quality of life ( EQ-5D ) , ( 4 ) evolution of stage of change ( Prochaska and DiClemente 's Stages of Change Model ) , ( 5 ) physical inactivity ( catalan version of Brief Physical Activity Assessment Tool ) , ( 6 ) number of steps walked ( pedometer and activPAL ) , ( 7 ) control based on analysis ( triglycerides , total cholesterol , HDL , LDL , glycemia and , glycated haemoglobin in diabetic patients ) and ( 8 ) blood pressure and anthropometric variables .
METHODS	All parameters will be assessed pre and post intervention and there will be a follow up three , six and twelve months after the intervention .
METHODS	A descriptive analysis of all variables and a multivariate analysis to assess differences among groups will be undertaken .
METHODS	Multivariate analysis will be carried out to assess time changes of dependent variables .
METHODS	All the analysis will be done under the intention to treat principle .
CONCLUSIONS	If the SEDESTACTIV intervention shows its effectiveness in reducing sitting time , health professionals would have a low-cost intervention tool for sedentary overweight and obese patients management .
BACKGROUND	A service of the U.S. National Institutes of Health .
BACKGROUND	Developed by the National Library of Medicine .
BACKGROUND	ClinicalTrials.gov NCT01729936 .

###24569324
OBJECTIVE	This study investigated the effects of low-dose tranexamic acid on post-coronary artery bypass surgery bleeding .
BACKGROUND	Diffuse microvascular bleeding is still a common problem after cardiac procedures .
BACKGROUND	This study was designed to evaluate the hemostatic effects of low-dose tranexamic acid in on-pump coronary artery bypass graft surgery .
METHODS	In this prospective randomized placebo-controlled study , 150 patients who were candidates for coronary artery bypass were enrolled and randomly assigned to 1 of 2 groups ( tranexamic acid or placebo ) .
METHODS	Total drainage volume and the need for transfusion as well as surgical complications were recorded and compared in the 2 groups .
RESULTS	There was significantly less mediastinal chest tube drainage up to 48h in the tranexamic acid group ( 432210mL ) compared to the placebo group ( 649235mL , p = 0.006 ) .
RESULTS	In the placebo group , 43 ( 58 % ) patients were given allogeneic blood during hospital stay compared to 22 ( 25 % ) in the tranexamic acid group ( p < 0.001 ) .
RESULTS	No significant difference in postoperative complications was seen .
CONCLUSIONS	The use of low-dose tranexamic acid can significantly reduce blood loss and need for transfusion , with no increase in complications .

###25440643
OBJECTIVE	The aim of this study was to investigate the relationship between intraoperative vasopressin infusion and postoperative cardiac enzymes .
METHODS	A prospective , double-blind , randomized , controlled study .
METHODS	A single tertiary cardiac center .
METHODS	One hundred consecutive patients undergoing cardiac surgery with or without cardiopulmonary bypass .
METHODS	The study was approved by the Institutional Review Board , and patients provided informed consent to participate .
METHODS	Patients were randomized by computer into 2 equal groups : Vasopressin or control .
METHODS	The blinded study included vasopressin administered at a dose of 1.8 U/h or 1.8 mL/h of normal saline , along with catecholamines .
METHODS	The drug was administered continually during surgery while patients needed catecholamines .
METHODS	The intervention was discontinued upon admission to the intensive care unit when information regarding the true character of the drug was reported to the doctor in charge of patients in the intensive care unit by one of the investigators .
METHODS	Primary outcomes were CK-MB and troponin T levels measured at 0 , 6 , and 12 hours postoperatively .
RESULTS	Of the 100 patients , 8 were excluded ; the remaining 92 were randomized to either the vasopressin ( n = 47 ) or control ( n = 45 ) group .
RESULTS	There were no significant differences in demographic data between the groups .
RESULTS	Postoperatively at 0 , 6 , and 12 hours , there were no differences in CK-MB ( U/l ) ( 37.5 57.9 v 32.0 21.5 , 29.4 41.1 v 24.4 23.1 , and 21.4 21.3 v. 21.8 32.4 , respectively ) and troponin T ( 752.4 638.2 v 762.7 557.1 , 753.8 507.3 v 777.6 515.0 , and 774.6 572.6 v 698.7 540.2 , respectively ) values .
CONCLUSIONS	Vasopressin infusion has been used to treat catecholamine-unresponsive shock .
CONCLUSIONS	In this study , intraoperative vasopressin was used safely as a possible first-line drug for treating hypotension ; however , it did not increase the levels of cardiac enzymes after cardiac surgery .

###25118156
BACKGROUND	Functional Strength Training ( FST ) could enhance recovery late after stroke .
BACKGROUND	The aim of this study was to evaluate the feasibility of a subsequent fully powered , randomized controlled trial .
METHODS	The study was designed as a randomized , observer-blind trial .
METHODS	Both interventions were provided for up to one hour a day , four days a week , for six weeks .
METHODS	Evaluation points were before randomization ( baseline ) , after six weeks intervention ( outcome ) , and six weeks thereafter ( follow-up ) .
METHODS	The study took place in participants ' own homes .
METHODS	Participants ( n = 52 ) were a mean of 24.4 months after stroke with a mean age of 68.3 years with 67.3 % male .
METHODS	All had difficulty using their paretic upper ( UL ) and lower limb ( LL ) .
METHODS	Participants were allocated to FST-UL or FST-LL by an independent randomization service .
METHODS	The outcome measures were recruitment rate , attrition rate , practicality of recruitment strategies , occurrence of adverse reactions , acceptability of FST , and estimation of sample size for a subsequent trial .
METHODS	Primary clinical efficacy outcomes were the Action Research Arm Test ( ARAT ) and the Functional Ambulation Categories ( FAC ) .
METHODS	Analysis was conducted using descriptive statistics and thematic analysis of participants ' views of FST .
METHODS	A power calculation used estimates of clinical efficacy variance to estimate sample size for a subsequent trial .
RESULTS	The screening process identified 1,127 stroke survivors of whom 52 ( 4.6 % ) were recruited .
RESULTS	The recruitment rate was higher for referral from community therapists than for systematic identification of people discharged from an acute stroke unit .
RESULTS	The attrition rate was 15.5 % at the outcome and follow-up time-points .
RESULTS	None of the participants experienced an adverse reaction .
RESULTS	The participants who remained in the study at outcome had received 68 % of the total possible amount of therapy .
RESULTS	Participants reported that their experience of FST provided a sense of purpose and involvement and increased their confidence in performing activities .
RESULTS	The power calculation provides estimation that 150 participants in each group will be required for a subsequent clinical trial .
CONCLUSIONS	This study found that a subsequent clinical trial was feasible with modifications to the recruitment strategy to be used .
BACKGROUND	Controlled-trials .
BACKGROUND	com ISCTN71632550 , 30 January 2009 .

###24765827
OBJECTIVE	To evaluate the usefulness of antibiotic + steroid irrigation of the middle ear in patients with otitis media with small perforation and pulsatile discharge .
METHODS	A prospective , randomised , evaluator-blinded study was carried at a single tertiary care centre over eight years , looking at 100 patients with chronic suppurative otitis media involving small tympanic membrane perforations and pulsatile mucopurulent discharge .
METHODS	The patients were randomised and divided into two groups .
METHODS	In group A , the examination under microscope , with suction cleaning of the external canal , was followed by irrigation of the middle ear with antibiotic + steroid solution for up to one week , while group B was prescribed self-administration of the same drops with systemic antibiotics .
METHODS	The patients were followed up daily for 10 days to monitor otorrhoea relief and on a weekly basis subsequently to monitor the healing of the tympanic membrane .
RESULTS	Forty-nine patients in group A had a dry ear after 3-7 days of daily suction and the irrigation of middle ear with the antibiotic + steroid solution and 44 had a healed tympanic membrane after an average three months of follow-up .
RESULTS	Five patients with dry ear but persistent perforation underwent tympanoplasty , while only one patient with a persistent ear discharge underwent mastoid exploration .
RESULTS	In group B , eight patients on oral antibiotics and self-administration of the same drops had dry ear while 34 had dry ear after receiving intravenous antibiotics .
RESULTS	Thirty perforations healed spontaneously and 12 required tympanoplasty .
RESULTS	In 8 patients , the tympano-mastoid was explored and these patients had dry , hearing ears only after surgery .
CONCLUSIONS	Patients with chronic suppurative otitis media involving small perforations and pulsatile discharge can be managed conservatively with simple suction cleaning + middle ear irrigation with antibiotics + steroid drops .

###24655407
BACKGROUND	Nutrients such as -3 fatty acids including fish oil components eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) suppress the growth and promote apoptosis of tumor cells , improve immune function and reduce the effects of systemic inflammatory response syndrome .
BACKGROUND	We sought to investigate the effect of -3 fish oil fat emulsion-based parenteral nutrition ( PN ) on nutritional state , immune function , inflammatory reaction , expression of tumor factors and complication incidence in patients after surgical resection of gastric cancer .
METHODS	Forty-eight patients after surgical operation of gastric tumor in hospital were randomly divided into the control group and intervention group .
METHODS	Patients in both groups were treated with iso-nitrogen and iso-caloric parenteral nutrition support .
METHODS	In addition , the intervention group received -3 fish oil fat emulsion and the control group received soybean oil .
METHODS	The indicators of nutrition , immune function and inflammation in the two groups were detected on the day before the operation and postoperative day 6 .
METHODS	The rate of complication was compared between the two groups .
RESULTS	There was no significant difference in nutritional state , liver function and renal function between the two groups ( P > 0.05 ) .
RESULTS	However , the levels of inflammatory markers were significantly decreased ( P < 0.01 ) , and the rate of complication was also decreased in the intervention group as compared with the control group .
CONCLUSIONS	-3 fish oil fat emulsion-based parenteral nutrition alleviates the inflammatory reaction and reduces the rate of inflammatory complications .

###24535759
OBJECTIVE	Cryolipolysis is a noninvasive and well-tolerated treatment for reduction of localized subcutaneous fat .
OBJECTIVE	Although several studies demonstrate the safety and efficacy of this procedure , volumetric fat reduction from this treatment has not been quantified .
OBJECTIVE	This prospective study investigated the change in volume of fat after cryolipolysis treatment using three-dimensional ( 3D ) photography .
METHODS	A prospective study of subjects treated with cryolipolysis on the flank ( love handle ) was performed at Massachusetts General Hospital .
METHODS	Volume measurements were performed with a Canfield Scientific Vectra three-dimensional camera and software to evaluate the amount of post procedure volume change .
METHODS	Clinical outcomes were assessed with caliper measurements , subject surveys , and blinded physician assessment of photographs .
RESULTS	Eleven subjects were enrolled in this study .
RESULTS	Each subject underwent a single cycle of cryolipolysis to one flank .
RESULTS	The untreated flank served as an internal control .
RESULTS	The follow-up time after treatment was 2 months .
RESULTS	The mean amount of calculated absolute fat volume loss using 3D photography from baseline to 2 months follow-up visit was 56.225.6 from the treatment site and 16.617.6 cc from the control ( P < 0.0001 ) .
RESULTS	A mean absolute difference of 39.6 cc between the treated and untreated sides was calculated at 2 months post-treatment .
RESULTS	Comparison of caliper measurements from baseline to 2 months post-treatment demonstrated significant reduction of the treated flank from 45.65.8 mm at baseline to 38.64.6 mm at 2 months post-treatment ( P < 0.001 ) .
RESULTS	The untreated flank did not show significant reduction with caliper measurements demonstrating 45.35.0 mm at baseline and 44.65.1 mm at 2 months post-treatment ( P = 0.360 ) .
RESULTS	No unexpected side effects or adverse events were reported .
RESULTS	Post-treatment satisfaction surveys demonstrated 82 % of subjects were satisfied with the results .
CONCLUSIONS	Cryolipolysis is a safe , well-tolerated , and effective noninvasive fat removal methodology that on average leads to 39.6 cc of fat loss of the treated flank at 2 months after a single treatment cycle .

###24434503
OBJECTIVE	Samatasvir is a pan-genotypic inhibitor of the hepatitis C ( HCV ) non-structural protein 5A ( NS5A ) .
OBJECTIVE	This study evaluated the antiviral activity , pharmacokinetics and safety of samatasvir monotherapy in treatment-nave subjects infected with HCV genotype 1-4 .
METHODS	Thirty-four genotype 1 and thirty genotype 2 , 3 or 4 subjects were randomized to receive for 3days placebo or samatasvir 25-100mg per day .
METHODS	Plasma samples for HCV RNA , pharmacokinetics and sequencing were collected up to day 10 .
RESULTS	Samatasvir achieved potent antiviral activity across genotypes : mean maximum reductions from baseline were 3.2-3 .6 ( genotype 1a ) , 3.0-4 .3 ( genotype 1b ) , 3.2-3 .4 ( genotype 3 ) , and 3.6-3 .9 ( genotype 4 ) log10/ml respectively ; no viral rebound was observed during the 3-day treatment period .
RESULTS	For genotype 2 HCV , samatasvir was active in subjects with NS5A L31 polymorphism at baseline ( individual range 2.5-4 .1 log10/ml ) , but showed minimal activity in those with baseline M31 polymorphism .
RESULTS	Samatasvir exhibited a long plasma half-life of approximately 20h which supports once daily dosing .
RESULTS	Samatasvir was well tolerated in all subjects with no safety-related discontinuations or serious adverse events .
RESULTS	The most common adverse events included constipation , nausea and headache and occurred at similar frequency in active and placebo subjects .
RESULTS	All events were mild or moderate in intensity .
RESULTS	There were no patterns or dose dependence of adverse events , vital signs , laboratory parameters or electrocardiograms .
CONCLUSIONS	Samatasvir 25-100mg monotherapy for 3days was well tolerated and induced a rapid and profound reduction in plasma HCV RNA in subjects infected with HCV genotype 1-4 .
CONCLUSIONS	Samatasvir is being evaluated in combination with other direct-acting antiviral agents in subjects with HCV infection .

###26215525
BACKGROUND	Hospital to Home ( H2H ) is a national quality improvement ( QI ) initiative composed of three recommended hospital interventions to improve the transition of care for hospitalized patients with heart disease .
BACKGROUND	A study was conducted to determine if enrollment of Department of Veterans Affairs ( VA ) hospitals in H2H and adoption of the recommended interventions would both increase following facilitation of an existing Heart Failure ( HF ) provider-based community of practice ( COP ) within the VA health care system .
BACKGROUND	The VA HF COP includes more than 800 VA providers and other VA staff from VA inpatient medical centers .
METHODS	In 2010 , 122 VA hospitals were randomized to facilitation using the VA HF COP ( intervention ) or no facilitation ( control ) .
METHODS	COP members from intervention hospitals were invited to periodic teleconferences promoting H2H and received multiple e-mails asking members to report interest and then progress in H2H implementation .
RESULTS	Among the 61 hospitals randomized to HF COP facilitation , 33 ( 54 % ) enrolled in H2H , compared with 6 ( 10 % ) of 61 control hospitals ( p < .001 ) at five months after randomization .
RESULTS	Of 38 intervention hospitals responding to the follow-up survey , 13 stated they had initiated 22 QI projects as a result of the H2H campaign .
RESULTS	Another 7 hospitals had planned H2H projects .
RESULTS	Of 20 control hospitals that responded , 5 had initiated 9 projects as a result of H2H , and no additional hospitals had plans to do so .
CONCLUSIONS	Facilitation using the VA HF COP was successful in increasing enrollment in the H2H initiative and providing implementation support for recommended QI projects .
CONCLUSIONS	Multihospital provider groups are a potentially valuable tool for implementation of national QI campaigns .

###24413262
OBJECTIVE	To assess the relationship between infant feeding , triple-antiretroviral prophylaxis and weight from 2 weeks ( baseline ) to 6 months postpartum among HIV-infected mothers in a mother-to-child transmission ( MTCT ) of HIV-prevention trial in five sub-Saharan African sites .
METHODS	HIV-infected pregnant women with CD4 cell counts of 200-500cells / l were counselled to choose breastfeeding to 6 months or replacement feeding from delivery .
METHODS	They were randomized to receive perinatal zidovudine and single-dose nevirapine or triple-antiretroviral MTCT prophylaxis until breastfeeding cessation .
METHODS	Mixed-effect linear models were used to compare maternal weight trajectories over time by infant feeding mode .
METHODS	Antiretroviral prophylaxis and BMI at baseline were examined as potential effect modifiers .
RESULTS	Among 797 mothers , 620 ( 78 % ) initiated breastfeeding .
RESULTS	Wasting ( BMI < 18.5 ) was rare at baseline ( 2 % ) , whereas overweight/obesity ( BMI25 ) was common ( 40 % ) .
RESULTS	In the model including all women , breastfeeding was not associated with weight loss up to 6 months , irrespective of baseline BMI and antiretroviral prophylaxis .
RESULTS	Triple-antiretroviral prophylaxis was associated with weight gain among replacement-feeding mothers with baseline BMI at least 25 ( +0.54 kg/month ; P < 0.0001 ) .
RESULTS	In the model including breastfeeding mothers only , triple-antiretroviral prophylaxis was associated with weight gain among mothers with baseline BMI at least 25 who ceased breastfeeding before 3 months postpartum ( +0.33 kg/month ; P = 0.03 ) .
CONCLUSIONS	The results suggest that breastfeeding up to 6 months postpartum is not detrimental for postpartum weight among well nourished HIV-infected mothers at intermediate-disease stage .
CONCLUSIONS	In the absence of breastfeeding or after weaning , triple-antiretroviral prophylaxis is associated with weight gain among women with high BMI , even after cessation of prophylaxis .

###24822235
OBJECTIVE	To compare the effectiveness of adding cyclobenzaprine , tizanidine , or placebo to patient education and a self-care management program for patients with myofascial pain and specifically presenting with jaw pain upon awakening .
METHODS	Forty-five patients with a diagnosis of myofascial pain based on the guidelines of the American Academy of Orofacial Pain participated in this 3-week study .
METHODS	The subjects were randomly assigned into one of three groups : placebo group , TZA group ( tizanidine 4 mg ) , or CYC group ( cyclobenzaprine 10 mg ) .
METHODS	Patients were evaluated for changes in pain intensity , frequency , and duration by using the modified Severity Symptoms Index and changes in sleep quality with the use of the Pittsburgh Sleep Quality Index .
METHODS	Data were analyzed by ANOVA and post-hoc or nonparametric statistical tests as appropriate .
RESULTS	All three groups had a reduction in pain symptoms and improvement of sleep quality based on a comparison of pretreatment and treatment scores .
RESULTS	However , no significant differences among the groups were observed at the posttreatment evaluation .
CONCLUSIONS	The use of tizanidine or cyclobenzaprine in addition to self-care management and patient education was not more effective than placebo for the management of patients with myofascial jaw pain upon awakening .

###25122980
OBJECTIVE	A controlled , clinical , double blind study was conducted to assess the efficacy of a sugar-free chewing gum containing calcium hydroxyapatite on dentin hypersensitivity , versus a placebo chewing gum with no active ingredients , after one and two weeks .
METHODS	One hundred and seven subjects joined the trial and were allocated into the test or the control ( placebo ) group by a random table .
METHODS	The test chewing gum contained calcium hydroxyapatite and dicalcium phosphate dihydrate ; the control chewing gum was identical , but without those ingredients .
METHODS	Participants were required to chew two pieces of their assigned chewing gum three times a day .
METHODS	Dentin hypersensitivity was evaluated following three clinical test indexes ( tactile , air blast , cold water ) and one subjective index .
RESULTS	One hundred subjects completed the study with 50 allocated to each group .
RESULTS	The clinical test index reductions after one and two weeks in the test group were , respectively , 36 % and 54 % for tactile , 35 % and 66 % for air blast , and 24 % and 49 % for cold water .
RESULTS	The clinical test index reductions after one and two weeks in the control group were , respectively , 16 % and 30 % for tactile , 11 % and 25 % for air blast , and 14 % and 31 % for cold water .
RESULTS	These reductions at one and two weeks were significant for the test group ( p < 0.01 ) .
RESULTS	For the control group they were significant ( p < 0.01 ) only at two weeks .
RESULTS	The comparisons between the groups at two weeks showed a significant statistical difference between the test and the control gum for tactile ( p < 0.01 ) , for air blast ( p < 0.001 ) , for cold water ( p < 0.05 ) , and for the subjective index ( p < 0.05 ) .
CONCLUSIONS	In this trial , the group using the chewing gum containing calcium hydroxyapatite had a statistically significant reduction in all clinical test indexes for dentin hypersensitivity after one and two weeks , and a statistically significant reduction compared to the control gum group .

###25764613
OBJECTIVE	To compare the effectiveness ofradial extracorporeal shock wave therapy ( rSWET ) and ultrasound therapy ( US ) in the treatment of chronic plantar fasciitis .
METHODS	Randomized controlled trial .
METHODS	Department of Rehabilitation Medicine , King Chulalongkorn Memorial Hospital .
METHODS	Thirty patients who were diagnosed with plantar fasciitis for at least 3 months and who had not responded to other forms of conservative treatment were recruited for this study .
METHODS	They were randomly divided into two groups of 15 patients .
METHODS	The rESWT group was treated with 1 session per week and the US group with 3 sessions per week , with both groups undergoing a total of 6 consecutive weeks of treatment .
METHODS	Visual analog scale ( VAS ) assessments were performed before and after treatment at 1 , 3 , 6 , 12 , and 24 weeks .
METHODS	The mobility subscale of the plantar fasciitis pain and disability scale ( PFPS ) was measured before and after treatment .
METHODS	Patient satisfaction was evaluated at the conclusion of the 6-week treatment protocol .
RESULTS	VAS pain intensity scores were significantly decreased in both groups ( p < 0.001 ) , when measured after treatment at 1 , 3 , 6 , 12 , and 24 weeks .
RESULTS	The VAS pain scores for the rESWT group dropped significantly more than those of the US group ( p < 0.001 ) .
RESULTS	At the end of treatment , the PFPS mobility subscale scores in both groups were significantly decreased ( p < 0.001 ) .
RESULTS	Similar to the VAS pain score outcome , the PFPS mobility subscale score for the rESWT group decreased significantly more than that of the US group ( p < 0.001 ) .
RESULTS	Patient satisfaction was significantly higher in the rESWT group , relative to the US group ( p = 0.025 ) .
CONCLUSIONS	In chronic plantar fasciitis treatment , both rESWT and US were found to be effective in reducing pain and increasing mobility ; however , statistical analysis showed that rESWT is significantly more effective than US .

###24682001
BACKGROUND	For older adults , the damaging effects of aging and stress can impair the ability to learn and sustain memory .
BACKGROUND	Humor , with its associated mirthful laughter , can reduce stress and cortisol , a stress hormone .
BACKGROUND	Chronic release of cortisol can damage hippocampus neurons , leading to impairment of learning and memory .
OBJECTIVE	The primary goal of this study was to determine whether watching a humorous video had an effect on short-term memory in an older population .
METHODS	The research team designed a randomized , controlled trial .
METHODS	The study took place at Loma Linda University in Loma Linda , California .
METHODS	The research team recruited 20 normal , healthy , older adults , 11 males and 9 females .
METHODS	The humor group ( n = 10 , mean = 69.3 3.7 y ) self-selected 1 of 2 humorous videos -- a Red Skelton comedy or a montage of America 's Funniest Home Videos -- and watched it for 20 min .
METHODS	A control group ( n = 10 , mean = 68.7 5.5 y ) sat calmly for 20 min and were not allowed to read , sleep , or talk on a cell phone .
METHODS	The Rey Auditory Verbal Learning Test was used to assess short-term memory -- learning ability , delayed recall , and visual recognition .
METHODS	Salivary cortisol levels were measured at predetermined times .
RESULTS	Learning ability improved by 38.5 % and 24.0 % in the humor and control groups , respectively ( P = .014 ) .
RESULTS	Delayed recall improved by 43.6 % and 20.3 % in the humor and control groups , respectively ( P = .029 ) .
RESULTS	Within the humor group , delayed recall ( 43.6 % ) was significant compared with learning ability ( 38.5 % ) ( P = .002 ) .
RESULTS	At 3 predetermined time points , significant decreases in salivary cortisol were observed in the humor group ( P = .047 , P = .046 , and P = .062 , respectively ) .
CONCLUSIONS	The study 's findings suggest that humor can have clinical benefits and rehabilitative implications and can be implemented in programs that support whole-person wellness for older adults .
CONCLUSIONS	Learning ability and delayed recall are important to these individuals for a better quality of life -- considering mind , body , spirit , social , and economic aspects .
CONCLUSIONS	Older adults may have age-associated memory deficiencies .
CONCLUSIONS	However , medical practitioners now can offer positive , enjoyable , and beneficial humor therapies to improve these deficiencies .

###25079040
OBJECTIVE	The purpose of this study was to investigate whether probiotics had an effect on proinflammatory markers and cytokines in overweight and obese individuals and whether they could have synergistic effects with weight-loss diets .
METHODS	A total of 75 healthy overweight and obese individuals completed this randomized doubled-blind controlled clinical trial .
METHODS	Participants were randomly assigned to groups consuming regular yogurt with a low-calorie diet ( LCD , RLCD ; n = 25 ) or receiving probiotic yogurt with LCD ( PLCD ; n = 25 ) or consuming probiotic yogurt without LCD ( PWLCD ; n = 25 ) for 8 weeks .
METHODS	The pribiotic regimen contained 200 g/day yogurt , enriched by Lactobacillus acidophilus La5 , Bifidobacterium BB12 , and Lactobacillus casei DN001 10 ( 8 ) colony-forming units/g .
METHODS	Body fat percentage , high-sensitive C-reactive protein ( hs-CRP ) , tumor necrosis factor-alpha ( TNF - ) , leptin , and mRNA levels of inflammation-related genes ( TNF - and RAR-related orphan receptor gamma [ ROR-t ] ) in peripheral blood mononuclear cells ( PBMCs ) were measured .
RESULTS	A reduction in body mass index ( BMI ) , fat percentage , and leptin level was observed that was more obvious in groups who received the weight-loss diet with probiotic yogurt .
RESULTS	Reduction in the gene expression of ROR-t was significant in the PLCD group ( p < 0.001 ) .
RESULTS	The expression of TNF - did not change among all groups after intervention .
RESULTS	The mean concentration of leptin was significantly decreased in all groups after the dietary intervention , but the mean changes in leptin level in the PLCD group was more prominent compared to the other two groups ( -2.38 , p < 0.001 [ PLCD ] vs -1.75 , p = 0.002 [ RLCD ] and -0.55 ng/mL , p = 0.12 [ PWLCD ] ) .
RESULTS	The reduction in serum levels of hs-CRP was more evident in the PWLCD group compared to the PLCD and RLCD groups after the 8-week intervention ( -3.4 , p = 0.03 vs -1.76 , p < 0.001 and -2.98 pg/mL , p < 0.001 , respectively ) .
CONCLUSIONS	Our results suggested that the weight-loss diet and probiotic yogurt had synergistic effects on T-cells subset specific gene expression in PBMCs , fat percentage , and body weight among overweight and obese individuals .

###25099425
BACKGROUND	Media literacy programs have shown potential for reduction of adolescent tobacco use .
BACKGROUND	We aimed to determine if an anti-smoking media literacy curriculum improves students ' media literacy and affects factors related to adolescent smoking .
METHODS	We recruited 1170 9th-grade students from 64 classrooms in 3 public urban high schools .
METHODS	Students were randomized by classroom to a media literacy curriculum versus a standard educational program .
METHODS	In an intent-to-treat analysis , we used multilevel modeling to determine if changes in study outcomes were associated with the curricular intervention , controlling for baseline student covariates and the clustering of students within classrooms .
RESULTS	Among participants , mean age was 14.5 years and 51 % were male , with no significant differences in baseline characteristics between groups .
RESULTS	Smoking media literacy changed more among intervention participants compared with control participants ( 0.24 vs. 0.08 , p < .001 ) .
RESULTS	Compared with controls , intervention students exhibited a greater reduction in the perceived prevalence of smoking ( -14.0 % vs. -4.6 % , p < .001 ) .
RESULTS	Among those initially susceptible to smoking , intervention participants more commonly reverted to being nonsusceptible post-intervention ( 24 % vs. 16 % , p = .08 ) .
CONCLUSIONS	A school-based media literacy curriculum is more effective than a standard educational program in teaching media literacy and improving perceptions of the true prevalence of smoking among adolescents .

###25156847
OBJECTIVE	We sought to determine and compare clinical profile and management of outpatients with heart failure with reduced ejection fraction ( HFREF ) treated by cardiologists and general practitioners ( GPs ) in Poland .
METHODS	All the 790 randomly selected cardiologists and GPs in the DATA-HELP registry , which included 5563 patients , filled out questionnaires about 10 consecutive outpatients with HFREF .
RESULTS	Outpatients managed by GPs were older ( 6910 vs 6612 years ) , and the prevalence of men was less marked ( 58 % vs 67 % ) .
RESULTS	They also had higher left ventricular ejection fraction ( 386 % vs 358 % ) and had more pulmonary congestion ( 63 % vs 49 % ) and peripheral oedema ( 66 % vs 51 % ) , compared with those treated by cardiologists ( all p < 0.001 ) .
RESULTS	Hypertension ( 74 % vs 66 % ) , previous stroke and/or transient ischaemic attack ( 21 % vs 16 % ) , diabetes ( 40 % vs 30 % ) , and chronic obstructive pulmonary disease ( 14 % vs 11 % ) were more common in outpatients of GPs ( all p < 0.001 ) .
RESULTS	GPs were less likely to prescribe - blocker ( 95 % vs 97 % , p < 0.01 ) , mineralocorticoid receptor antagonist ( MRA ) ( 56 % vs 64 % , p < 0.001 ) , and loop diuretic ( 61 % vs 64 % , p < 0.05 ) or use PCI ( 33 % vs 44 % , p < 0.001 ) , CABG ( 11 % vs 16 % , p < 0.001 ) , ICD ( 4 % vs 10 % , p < 0.001 ) , or CRT ( 1 % vs 5 % , p < 0.001 ) .
RESULTS	Prescription of renin-angiotensin system inhibitors ( 94 % vs 94 % , p > 0.2 ) and digoxin ( 20 % vs 21 % , p > 0.2 ) by GPs and cardiologists was similar .
CONCLUSIONS	In contemporary Poland , most outpatients with HFREF receive drugs that improve survival and undergo revascularisation procedures , although devices are rare , but the clinical profiles and management of those treated by GPs and cardiologists differ .
CONCLUSIONS	Outpatients treated by GPs are older and have more co-morbidities .
CONCLUSIONS	Outpatients treated by cardiologists more commonly receive - blocker , MRA , ICD , and CRT , and undergo coronary revascularisations .

###25453134
OBJECTIVE	Robust clinical data evaluating fibrosis progression in hepatitis C virus ( HCV ) liver transplant patients receiving an mTOR inhibitor vs. calcineurin inhibitor ( CNI ) are lacking .
OBJECTIVE	To evaluate fibrosis progression in maintenance liver transplant patients receiving everolimus - or CNI-based immunosuppression .
METHODS	In a randomised , multicentre , open-label study , 43 maintenance liver transplant patients with recurrent HCV infection were randomised to continue CNI-based immunosuppression or switch to everolimus .
RESULTS	For patients with biopsy data at month 12 , mean Ishak-Knodell fibrosis score at baseline was 2.6 0.9 ( n = 14 ) with everolimus vs. 1.9 1.1 ( n = 18 ) with CNI ( P = 0.043 ) , and 1.9 1.2 vs. 2.2 1.3 at month 12 .
RESULTS	Ishak-Knodell fibrosis score decreased from baseline to month 12 by a mean of -0.7 1.1 with everolimus , but increased by 0.2 1.2 with CNI ( P = 0.046 ) .
RESULTS	No acute rejection or graft losses occurred up to month 12 .
RESULTS	Estimated GFR at month 12 was 65.6 ml/min/1 .73 m with everolimus and 62.2 ml/min/1 .73 m with CNI [ mean difference 3.4 ml/min/1 .73 m compared to CNI control group , 95 % CI -4.9 , 11.8 ml/min/1 .73 m , P = 0.411 ( analysis of covariance adjusting for baseline GFR ) ] .
RESULTS	Adverse events occurred in 95.5 % of everolimus patients and 71.4 % of CNI patients ( serious adverse events 31.8 % and 0.0 % , respectively ) .
RESULTS	Adverse events led to everolimus discontinuation in five patients ( 22.7 % ) .
CONCLUSIONS	This exploratory study suggests that conversion from CNI to everolimus reduces progression of liver fibrosis , and preserves renal function without jeopardising efficacy in liver transplant recipients with recurrent HCV , but is associated with a higher incidence of adverse events and serious adverse events .
CONCLUSIONS	These preliminary findings merit examination in a larger trial .

###24436135
BACKGROUND	In this study , we evaluated the effect on cognitive function of memantine , behavioral and psychological symptoms of dementia , and the care burden , in patients with moderate-to-severe Alzheimer 's disease ( AD ) .
BACKGROUND	Furthermore , with near-infrared spectroscopy ( NIRS ) , we examined the association between effect of memantine and brain blood flow .
METHODS	We evaluated the effect of memantine administration from baseline on Clinical Global Impression-Improvement scale , mini mental state examination ( MMSE ) , Clock Drawing Test ( CDT ) , Neuropsychiatric Inventory ( NPI ) , Japanese version of the Zarit Burden Interview ( J-ZBI ) and NIRS in two groups , donepezil administration memantine combination group ( combination group , n = 19 ) donepezil administration memantine non-administration group ( control group , n = 18 ) were assessed at weeks 0 , 4 , 12 , and 24 .
RESULTS	Significant difference was found between the combination group and the control group in the score variation of Clinical Global Impression-Improvement scale , MMSE , CDT , NPI , and J-ZBI .
RESULTS	In the NIRS measurements , trend oxyhemoglobin reduced suppression was observed in some channels centered on the superior frontal gyrus .
RESULTS	A significant correlation was observed in the scores of MMSE , CDT , NPI , and J-ZBI .
RESULTS	In addition , a significant positive correlation was also observed between the number of words in NIRS and scores of MMSE and CDT .
CONCLUSIONS	In this study , by administering memantine in AD patients that inhibit the reduction of cerebral blood flow in the prefrontal area and improve clinical symptoms overall cognitive function , behavioral and psychological symptoms of dementia , thereby reducing the care burden of caregivers was suggested .

###25616919
OBJECTIVE	This study compared the timing of onset of antiplatelet action after treatment with clopidogrel and prasugrel at first medical contact in patients with ST-segment elevation myocardial infarction ( STEMI ) scheduled for primary percutaneous coronary intervention ( PPCI ) .
BACKGROUND	Little is known about the timing of onset of antiplatelet action after a pre-percutaneous coronary intervention ( PCI ) loading dose of clopidogrel or prasugrel in patients with STEMI .
METHODS	This double-blind , prospective study randomized 62 patients with STEMI scheduled for PPCI in the ambulance or the emergency department to 60 mg prasugrel ( n = 31 ) or 600 mg clopidogrel ( n = 31 ) .
METHODS	The primary endpoint was the platelet reactivity index ( PRI ) measured with the vasodilator-stimulated phosphoprotein assay 2 h after intake of the study medication .
METHODS	Secondary endpoints were PRI after 4 h , TIMI ( Thrombolysis In Myocardial Infarction ) patency of the infarct-related artery before and after PCI , and clinical events until day 30 .
RESULTS	The PRI after 2 h ( 50.4 32.7 % vs. 66.3 22.2 % ; p = 0.035 ) and after 4 h ( 39.1 27.5 % vs. 54.5 49.3 % ; p = 0.038 ) were significantly lower with prasugrel compared with clopidogrel .
RESULTS	In addition , the rate of patients with a PRI < 50 % tended to be higher with prasugrel compared with clopidogrel after 2 h ( 46.7 % vs. 28.6 % ; p = 0.15 ) and after 4 h ( 63.0 % vs. 38.9 % ; p = 0.06 ) .
RESULTS	There were no significant differences in TIMI 2/3 patency before PCI ( 39.2 % vs. 31.0 % ; p = 0.43 ) and TIMI 3 patency after PCI ( 88.5 % vs. 89.3 % ; p = 0.92 ) .
CONCLUSIONS	The pre-PCI administration of prasugrel in patients with STEMI undergoing PPCI was associated with a significant faster platelet inhibition compared with clopidogrel .
CONCLUSIONS	Therefore , prasugrel should be preferred to clopidogrel in this setting .
CONCLUSIONS	( ETAMI-Study : Early Thienopyridine Treatment to Improve Primary PCI in Patients With Acute Myocardial Infarction ; NCT01327534 ) .

###25583916
OBJECTIVE	To test the effectiveness of cognitive-behavioral counseling on the rate and duration of exclusive breastfeeding ( EBF ) during the first 6 months of an infant 's life compared with routine counseling .
METHODS	A single blind cluster-randomized controlled trial was undertaken in 40 Union Councils of a rural district in the northwest province of Pakistan between May 2009 and April 2010 .
METHODS	By simple unmatched randomization , 20 Union Councils were each allocated to intervention and control arms .
METHODS	Two hundred twenty-four third trimester pregnant women in the intervention and 228 third trimester pregnant women in the control arm were enrolled and followed-up biweekly until 6 months postpartum .
METHODS	Analyses were by intention to treat .
METHODS	Mothers in the intervention group received 7 sessions of cognitive-behavioral counseling from antenatal to 6 months postpartum , whereas the control group received an equal number of routine sessions .
METHODS	Proportion of mothers exclusively breastfeeding at 6 months postpartum and duration of EBF through these 6 months was assessed .
RESULTS	At 6 months postpartum , 59.6 % of mothers in the intervention arm and 28.6 % in the control arm were exclusively breastfeeding .
RESULTS	This translates into a 60 % reduced risk of stopping exclusively breastfeeding during the first 6 months ( adjusted hazard ratio , 0.40 [ 95 % confidence interval : 0.27-0 .60 ] , P < .001 ) .
RESULTS	Mothers in the intervention group were half as likely to use prelacteal feeds with their infants ( adjusted relative risk , 0.51 [ 95 % confidence interval : 0.34-0 .78 ] ) .
CONCLUSIONS	Compared with routine counseling , cognitive-behavioral counseling significantly prolonged the duration of EBF , doubling the rates of EBF at 6 months postpartum .

###24475198
BACKGROUND	The aim of this study was to determine the incidence and seasonal pattern of malaria in children in South-West Burkina Faso , and to compare , in a randomized trial , characteristics of cases detected by active and passive surveillance .
BACKGROUND	This study also enabled the planning of a malaria vaccine trial .
METHODS	Households with young children , located within 5 kilometers of a health facility , were randomized to one of two malaria surveillance methods .
METHODS	In the first group , children were monitored actively .
METHODS	Each child was visited twice weekly ; tympanic temperature was measured , and if the child had a fever or history of fever , a malaria rapid diagnostic test was performed and a blood smear collected .
METHODS	In the second group , children were monitored passively .
METHODS	The child 's parent or caregiver was asked to bring the child to the nearest clinic if he was unwell .
METHODS	Follow up lasted 13 months from September 2009 .
RESULTS	Incidence of malaria ( Fever with parasitaemia 5,000 / L ) was 1.18 episodes/child/year in the active cohort and 0.89 in the passive cohort ( rate ratio 1.32 , 95 % CI 1.13-1 .54 ) .
RESULTS	Malaria cases in the passive cohort were more likely to have high grade fever ; but parasite densities were similar in the two groups .
RESULTS	Incidence was highly seasonal ; when a specific case definition was used , about 60 % of cases occurred within the 4 months June-September .
CONCLUSIONS	Passive case detection required at least a 30 % -40 % increase in the sample size for vaccine trials , compared to active detection , to achieve the same power .
CONCLUSIONS	However we did not find any evidence that parasite densities were higher with passive than with active detection .
CONCLUSIONS	The incidence of malaria is highly seasonal and meets the WHO criteria for Seasonal Malaria Chemoprevention ( SMC ) .
CONCLUSIONS	At least half of the malaria cases in these children could potentially be prevented if SMC was effectively deployed .

###25151658
OBJECTIVE	To study the effects of topical intranasal mometasone furoate nasal spray for management of otitis media with effusion in children aged 2-12 years with adenoidal hypertrophy and its impact on change in quality of life .
METHODS	A prospective randomized double blind interventional placebo control study was conducted .
METHODS	Hundred patients of endoscopic grade 3 or 4 adenoidal hypertrophy aged 2-12 years were enrolled in this study .
METHODS	Among these sixty two patients had persistent bilateral otitis media with effusion more than three months .
METHODS	These were randomly divided into two groups , group A and group B. Group A received mometasone nasal spray for six months and group B received saline nasal spray for the same period .
METHODS	Patients were evaluated with symptom , pure tone audiometry wherever possible , pneumatic otoscopic examination and tympanogram at 0 , 8 and 24 weeks .
RESULTS	Resolution of otitis media with effusion in study group ( 28 out of 30 ) was significantly higher as compared control group ( 16 out of 32 ) ( p value 0.0004 ) .
RESULTS	A significant improvement in hearing and symptoms was seen in the study group ( p < 0.04 ) .
RESULTS	Statistically significant change in quality of life was seen with mometasone nasal spray ( 37.11 ) as compared to saline nasal spray ( 11.02 ) ( p value 0.0001 ) .
CONCLUSIONS	Mometasone nasal spray appears to be effective for the treatment of otitis media with effusion in patients of adenoidal hypertrophy .

###25823480
BACKGROUND	Conventional methods of caries removal are commonly associated with pain , fear and discomfort .
BACKGROUND	Chemomechanical methods were introduced to instill a positive dental attitude .
BACKGROUND	Agents like GK-101 , Caridex , Carisolv did not prove effective alternatives owing to their high cost , need of special instruments and taste of chlorine .
BACKGROUND	A new chemomechanical agent , Papacarie , has been introduced to overcome these deficiencies .
OBJECTIVE	This study was aimed to compare the effectiveness and tolerance of Papacrie with the conventional method .
METHODS	25 children with at least two primary teeth with broad cavitated occlusal or cervical lesion were selected .
METHODS	One carious tooth from each patient was randomly treated with each of Papacarie and conventional drilling method , one after the other .
METHODS	Time taken for caries excavation , child 's pain perception , change in anxiety levels , microbial flora and child 's preference of treatment were recorded separately for both the methods .
RESULTS	Although the mean time taken for caries removal by the Papacarie method was slightly longer ( P0 .05 ) but it led to reduction in pain and anxiety ( p < 0.05 ) .
RESULTS	The viable bacterial counts were significantly reduced by either of the two methods ( P < 00001 ) .
RESULTS	More patients preferred Papacarie over conventional method of treatment ( P < 0.05 ) .
CONCLUSIONS	Papacrie method seems to be a better alternative to conventional method of caries removal .

###25449195
OBJECTIVE	To determine whether functional electrical stimulation ( FES ) - assisted active cycling is more effective than active cycling without FES concerning walking and balance .
OBJECTIVE	Specifically , walking ability was classified as to the amount of personal assistance needed to be able to walk and balance was evaluated for static and dynamic balance tasks .
METHODS	Monocentric , randomized , single-blinded , controlled trial .
METHODS	Neurologic rehabilitation hospital .
METHODS	Patients with severe hemiparesis due to stroke ( N = 40 ) .
METHODS	Twenty minutes of active leg cycling with or without FES applied to the paretic vastus medialis and rectus femoris of quadriceps and to the biceps femoris and semitendinosus muscles , 3 times/wk for 4 weeks .
METHODS	Functional ambulation classification ( FAC ) and performance-oriented mobility assessment ( POMA ) were the primary outcome measures .
METHODS	The leg subscale of the motricity index ( MI ) and the modified Ashworth scale were the secondary outcome measures .
METHODS	Evaluation was done before and after the intervention period and after an additional 2 weeks .
RESULTS	After the intervention , the FAC , POMA , and the MI ( P < .016 ) for both intervention groups improved significantly .
RESULTS	The FAC of the control group increased by a median of 1 category and that of the FES group by 2 categories .
RESULTS	The median change in POMA was 2 and 4 points for the control group and the FES group , respectively .
RESULTS	The Mann-Whitney U test between-group comparisons revealed that these gains were significantly better in the FES group for both the FAC ( U = 90 ; z = -2.58 ; P = .013 ; r = -.42 ) and the POMA ( U = 60 ; z = -3.43 ; P < .0004 ; r = -.56 ) .
RESULTS	Because of missing data and slightly decreased effect sizes during the follow-up phase ( FAC , r = -.33 ; POMA , r = -.41 ) , differences did not reach statistically significant P values .
RESULTS	The MI leg subscale showed significant improvements in both groups .
RESULTS	However , there were no significant differences between the groups at any time .
RESULTS	No changes were observed on the modified Ashworth scale .
CONCLUSIONS	FES-assisted active cycling seems to be a promising intervention during rehabilitation in patients with stroke .

###25656999
BACKGROUND	We previously reported the initial results of the first multicenter , randomized , double-blind , placebo-controlled clinical trial of peanut sublingual immunotherapy ( SLIT ) , observing a favorable safety profile associated with modest clinical and immunologic effects in the first year .
OBJECTIVE	We sought to provide long-term ( 3-year ) clinical and immunologic outcomes for our peanut SLIT trial .
OBJECTIVE	Key end points were ( 1 ) percentage of responders at 2 years ( ie , could consume 5 g of peanut powder or a 10-fold increase from baseline ) , ( 2 ) percentage reaching desensitization at 3 years , ( 3 ) percentage attaining sustained unresponsiveness after 3 years , ( 4 ) immunologic end points , and ( 5 ) assessment of safety parameters .
METHODS	Response to treatment was evaluated in 40 subjects aged 12 to 40 years by performing a 10-g peanut powder oral food challenge after 2 and 3 years of daily peanut SLIT therapy .
METHODS	At 3 years , SLIT was discontinued for 8 weeks , followed by another 10-g oral food challenge and an open feeding of peanut butter to assess sustained unresponsiveness .
RESULTS	Approximately 98 % of the 18,165 doses were tolerated without adverse reactions beyond the oropharynx , with no severe symptoms or uses of epinephrine .
RESULTS	A high rate ( > 50 % ) discontinued therapy .
RESULTS	By study 's end , 4 ( 10.8 % ) of 37 SLIT-treated participants were fully desensitized to 10 g of peanut powder , and all 4 achieved sustained unresponsiveness .
RESULTS	Responders at 2 years showed a significant decrease in peanut-specific basophil activation and skin prick test titration compared with nonresponders .
CONCLUSIONS	Peanut SLIT induced a modest level of desensitization , decreased immunologic activity over 3 years in responders , and had an excellent long-term safety profile .
CONCLUSIONS	However , most patients discontinued therapy by the end of year 3 , and only 10.8 % of subjects achieved sustained unresponsiveness .

###25141250
OBJECTIVE	To compare the safety and efficacy of U.S. Food and Drug Administration ( FDA ) - recommended doses of labetalol and nicardipine for hypertension ( HTN ) management in a subset of patients with renal dysfunction ( RD ) .
METHODS	Randomized , open label , multicenter prospective clinical trial .
METHODS	Thirteen United States tertiary care emergency departments .
METHODS	Subgroup analysis of the Evaluation of IV Cardene ( Nicardipine ) and Labetalol Use in the Emergency Department ( CLUE ) clinical trial .
METHODS	The subjects were 104 patients with RD ( i.e. , creatinine clearance < 75 mL/min ) who presented to the emergency department with a systolic blood pressure ( SBP ) 180 mmHg on 2 consecutive readings and for whom the emergency physician felt intravenous antihypertensive therapy was desirable .
METHODS	The FDA recommended doses of either labetalol or nicardipine for HTN management .
METHODS	The number of patients achieving the physician 's predefined target SBP range within 30 minutes of treatment .
RESULTS	Patients treated with nicardipine were within target range more often than those receiving labetalol ( 92 % vs. 78 % , P = 0.046 ) .
RESULTS	On 6 SBP measures , patients treated with nicardipine were more likely to achieve the target range on either 5 or all 6 readings than were patients treated with labetalol ( 46 % vs. 25 % , P = 0.024 ) .
RESULTS	Labetalol patients were more likely to require rescue medication ( 27 % vs. 17 % , P = 0.020 ) .
RESULTS	Adverse events thought to be related to either treatment group were not reported in the 30-minute active study period , and patients had slower heart rates at all time points after 5 minutes ( P < 0.01 ) .
CONCLUSIONS	In severe HTN with RD , nicardipine-treated patients are more likely to reach a target blood pressure range within 30 minutes than are patients receiving labetalol .
CONCLUSIONS	Within 30 minutes of administration , nicardipine is more efficacious than labetalol for acute blood pressure control in patients with RD. .

###24886353
BACKGROUND	Dementia affects 35 million people worldwide and is currently incurable .
BACKGROUND	Many cases may be preventable because regular participation in physical , mental and social leisure activities during middle age is associated with up to 47 % dementia risk reduction .
BACKGROUND	However , the majority of middle-aged adults are not active enough .
BACKGROUND	MCI is therefore a clear target for activity interventions aimed at reducing dementia risk .
BACKGROUND	An active lifestyle during middle age reduces dementia risk but it remains to be determined if increased activity reduces dementia risk when MCI is already evident .
BACKGROUND	Before this can be investigated conclusively , complex multimodal activity programmes are required that ( 1 ) combine multiple health promoting activities , ( 2 ) engage people with MCI , and ( 3 ) result in sufficient adherence rates .
METHODS	We designed the ThinkingFit programme to engage people with MCI in a complex intervention comprised of three activity components : physical activity , group-based cognitive stimulation ( GCST ) and individual cognitive stimulation ( ICST ) .
METHODS	Engagement and adherence was promoted by applying specific psychological techniques to enhance behavioural flexibility in an early pre-phase and during the course of the intervention .
METHODS	To pilot the intervention , participants served as their own controls during a 6 - to 12-week run-in period , which was followed by 12weeks of activity intervention .
RESULTS	Out of 212 MCI patients screened , 163 were eligible , 70 consented and 67 completed the intervention ( mean age 74years ) .
RESULTS	Activity adherence rates were high : physical activity = 71 % ; GCST = 83 % ; ICST = 67 % .
RESULTS	Significant treatment effects ( p < .05 ) were evident on physical health outcomes ( decreased BMI and systolic blood pressure , [ pre/post values of 26.3 / 25.9 kg/m2 and 145/136mmHg respectively ] ) , fitness ( decreased resting and recovery heart rate [ 68/65bpm and 75/69bpm ] ) , and cognition ( improved working memory [ 5.3 / 6.3 items ] ) .
CONCLUSIONS	We found satisfactory recruitment , retention and engagement rates , coupled with significant treatment effects in elderly MCI patients .
CONCLUSIONS	It appears feasible to conduct randomized controlled trials of the dementia prevention potential of complex multimodal activity programmes like ThinkingFit .
BACKGROUND	ClinicalTrials.gov registration nr : NCT01603862 ; date : 17/5/2012 .

###25654959
OBJECTIVE	To evaluate the clinical and microbiological effects of systemic levofloxacin ( LFX ) in subjects with Aggregatibacter actinomycetemcomitans-associated chronic periodontitis ( AA-ACP ) .
METHODS	Subjects with severe periodontitis with subgingival detection of A. actinomycetemcomitans were randomly divided into two treatment groups ; a test group ( n = 35 ) that received scaling and root planing ( SRP ) and LFX ( 500 mg o.d. ) and a control group ( n = 34 ) that received SRP and placebo ( o.d. ) for 10 days .
METHODS	Plaque index ( PI ) , gingival index ( GI ) , percent of sites with bleeding on probing ( % BoP ) , probing depth ( PD ) and clinical attachment level ( CAL ) were recorded and subgingival plaque samples were cultivated for detection of A. actinomycetemcomitans at baseline to 6 months at various intervals .
RESULTS	Subjects receiving LFX showed the greatest improvements in mean PD and CAL .
RESULTS	The difference in the reduction of PD and CAL in the two groups was significant at 1 , 3 and 6 months for PD and 3 and 6 months for CAL ( p < 0.05 ) .
RESULTS	The inter-group difference in PI , GI and % BoP was not significant at any interval .
RESULTS	Detectable levels of A. actinomycetemcomitans were significantly less in the test group 3 and 6 months post-therapy .
CONCLUSIONS	Systemic LFX as an adjunct to SRP improves clinical outcomes and suppresses A. actinomycetemcomitans below detectable levels .

###24372492
OBJECTIVE	Driving under the influence ( DUI ) enforcement practices and sanctions contribute differentially to the certainty , swiftness , and severity of punishment , which are the key components of general deterrence theory .
OBJECTIVE	This study used a conjoint experiment to understand the decision-making process of potential DUI offenders and tested how variation in enforcement and legal punishment affects drinking and driving decisions .
OBJECTIVE	It sought to verify and quantify the unique deterrent effects of certainty , severity , and swiftness and to predict the rates of drinking and driving in different legal environments .
METHODS	One hundred twenty-one college seniors and graduate students at the University of Maryland participated in the Web-based conjoint experiment .
METHODS	They were randomly assigned to 4 blocks , each of which included 9 hypothetical scenarios composed of different levels of DUI enforcement and penalties .
METHODS	Respondents were asked to state their likelihood of drinking and driving under each scenario , as well as their estimated chance of being caught by the police for DUI .
RESULTS	Intensified enforcement , harsh jail penalty , and immediate long license suspension were found to be the strongest deterrents to drinking and driving .
RESULTS	Alternative ways to get home were also important in reducing people 's willingness to drive .
RESULTS	These factors accounted for most of the attribute effect on the DUI decision , whereas delayed punishment due to judicial processing , fine penalty , and legal blood alcohol concentration ( BAC ) limit had negligible effects .
RESULTS	For the personal characteristics , college seniors and those who had previously driven after drinking were more likely to choose to drink and drive , whereas those who expect a jail penalty for a DUI offense were less likely to drive .
CONCLUSIONS	Our research confirmed and quantified certainty of punishment as the greatest deterrent to DUI , but it also indicated the equally important effect of a severe jail penalty .
CONCLUSIONS	It provides evidence on the feasibility of using a conjoint experiment in future studies to understand the general driver population and , with the help of a simulation tool , to predict DUI decisions in different legal environments .
CONCLUSIONS	Such predictions can be used to better inform policy decisions on developing targeted general deterrence programs in different communities .

###25170104
BACKGROUND	Infant responses to vaccines can be impeded by maternal antibodies and immune system immaturity .
BACKGROUND	It is therefore unclear whether human immunodeficiency virus type 1 ( HIV-1 ) vaccination would elicit similar responses in adults and infants .
METHODS	HIV-1 Env-specific antibody responses were evaluated in 2 completed pediatric vaccine trials .
METHODS	In the Pediatric AIDS Clinical Trials Group ( PACTG ) 230 protocol , infants were vaccinated with 4 doses of Chiron rgp120 with MF59 ( n = 48 ) , VaxGen rgp120 with aluminum hydroxide ( alum ; n = 49 ) , or placebo ( n = 19 ) between 0 and 20 weeks of age .
METHODS	In PACTG 326 , infants received 4 doses of ALVAC-HIV-1 / AIDSVAX B/B with alum ( n = 9 ) or placebo ( n = 13 ) between 0 and 12 weeks of age .
RESULTS	By 52 weeks of age , the majority of maternally acquired antibodies had waned and vaccine Env-specific immunoglobulin G ( IgG ) responses in vaccinees were higher than in placebo recipients .
RESULTS	Chiron vaccine recipients had higher and more-durable IgG responses than VaxGen vaccine recipients or ALVAC/AIDSVAX vaccinees , with vaccine-elicited IgG responses still detectable in 56 % of recipients at 2 years of age .
RESULTS	Remarkably , at peak immunogenicity , the concentration of anti-V1V2 IgG , a response associated with a reduced risk of HIV-1 acquisition in the RV144 adult vaccine trial , was 22-fold higher in Chiron vaccine recipients , compared with RV144 vaccinees .
CONCLUSIONS	As exemplified by the Chiron vaccine regimen , vaccination of infants against HIV-1 can induce robust , durable Env-specific IgG responses , including anti-V1V2 IgG .

###24557963
OBJECTIVE	Adverse events during colonoscopy are more likely to occur in elderly .
OBJECTIVE	To avoid the adverse events without decreasing the bowel cleanliness is still an unsolved problem .
OBJECTIVE	The aim of this study was to determine the effect of enteral nutrition before colonoscopy in a randomized controlled trail .
METHODS	A total of 108 patients over sixty-five years of age and indicated for colonoscopy were randomized into four groups .
METHODS	Group 1 received a solution of two packages of polyethylene glycol electrolyte powder dissolved in 2000 mL water .
METHODS	Group 2 received 500 mL of enteral nutrition plus polyethylene glycol of the same dosage as in group 1 .
METHODS	Group 3 received 200 mL of 25 % magnesium sulfate solution .
METHODS	Group 4 received 500 mL of enteral nutrition plus 25 % magnesium sulfate solution of the same dosage as in group 3 .
METHODS	The intestinal cleaning and various physiological indications were measured before , after bowel preparation , and during colonoscopy .
RESULTS	No significant difference in the quality of colon cleansing was found among the four groups .
RESULTS	The incidence of adverse effects in groups 2 and 4 was less than in groups 1 and 3 .
CONCLUSIONS	Additional enteral nutrition in elderly patients before bowel preparation did not affect the quality of colon cleansing .
CONCLUSIONS	However , the process can significantly reduce the incidence of adverse effects .

###24955452
BACKGROUND	Endoscopic variceal ligation ( EVL ) is effective in preventing esophageal variceal rebleeding .
BACKGROUND	However , the optimal EVL interval remains unclear .
OBJECTIVE	To investigate the effectiveness and safety of EVL using two intersession intervals .
OBJECTIVE	methods : From January 2009 to October 2012 , 214 patients with acute esophageal variceal bleeding were screened .
OBJECTIVE	Emergency ligation was performed for patients with acute variceal bleeding .
OBJECTIVE	After achieving hemodynamic stability , eligible patients ( n = 70 ) were randomized to either the monthly group or the biweekly group .
RESULTS	Median time from randomization to variceal obliteration was 2.7 months in the monthly group and 1.7 months in the biweekly group , at a mean of 2.3 2.0 and 3.0 1.8 sessions , respectively .
RESULTS	After a median follow up of 23 months , six patients ( 17 % ) in the monthly group and nine patients ( 26 % ) in the biweekly group developed upper gastrointestinal rebleeding ( P = 0.382 ) .
RESULTS	Esophageal variceal rebleeding occurred in six patients ( 17 % ) in the monthly group and in seven patients ( 20 % ) in the biweekly group ( P = 0.759 ) .
RESULTS	No rebleeding from EVL ulcers occurred in the monthly group and was 5.7 % ( n = 2 ) for the biweekly group .
RESULTS	Both treatment groups had similar rates of esophageal variceal recurrence and mortality .
RESULTS	Notably , the incidence of post-EVL ulcers in the monthly group was lower than that in the biweekly group ( 11 % vs 57 % , P < 0.001 ) .
CONCLUSIONS	Patients receiving EVL monthly had similar rebleeding rate , variceal recurrence , and mortality to those receiving EVL biweekly for secondary prophylaxis of variceal bleeding ; however , the monthly interval was associated with fewer post-EVL ulcers found at follow-up endoscopies .

###25542604
OBJECTIVE	The aim of this pilot study was to evaluate the effect of low-level laser therapy on pain , mandibular movements , and occlusal contacts in adolescents and young adults with temporomandibular disorder .
METHODS	Individuals aged 14 to 23 years were evaluated .
METHODS	The Research Diagnostic Criteria for Temporomandibular Disorders were used for the diagnosis of temporomandibular disorders .
METHODS	Pain was assessed with a visual analog scale .
METHODS	Occlusal contacts were recorded using the T-Scan III program ( Tekscan , Boston , MA ) .
METHODS	The participants were randomly allocated to 2 groups : active or placebo laser treatment .
METHODS	The laser parameters were as follows : wavelength of 780 nm , energy density of 33.5 J/cm ( 2 ) , power of 50 mW , power density of 1.67 W/cm ( 2 ) , and 20-second exposure time .
METHODS	The Kolmogorov-Smirnov test was used to determine the normality of the data distribution .
METHODS	The paired t test was used for the comparisons of the pretreatment and post-treatment results .
METHODS	The SPSS program for Windows ( version 15.0 ; SPSS , Chicago , IL ) was used for all analyses , with the level of significance set at 5 % ( P < .05 ) .
RESULTS	No statistically significant differences between groups were found for the right and left anterior temporal muscles ( P = .3801 and P = .5595 , respectively ) , superior masseter muscles ( P = .087 and P = .1969 , respectively ) , medial masseter muscles ( P = .2241 and P = .076 , respectively ) , or inferior masseter muscles ( P = .5589 and P = .3268 , respectively ) after treatment .
CONCLUSIONS	No statistically significant differences were found regarding pain , mandibular range of motion , or the distribution of occlusal contacts after treatment with low-level laser therapy .
CONCLUSIONS	These preliminary results need to be verified in a larger sample of patients to confirm the lack of response to low-level laser therapy .

###25886810
BACKGROUND	External stents inhibit saphenous vein graft ( SVG ) intimal hyperplasia in animal studies .
BACKGROUND	We investigated whether external stenting inhibits SVG diffuse intimal hyperplasia 1 year after coronary artery bypass graft surgery .
METHODS	Thirty patients with multivessel disease undergoing coronary artery bypass graft surgery were enrolled .
METHODS	In addition to an internal mammary artery graft , each patient received one external stent to a single SVG randomly allocated to either the right or left coronary territories ; and one or more nonstented SVG served as the control .
METHODS	Graft patency was confirmed at the end of surgery in all patients .
METHODS	The primary endpoint was SVG intimal hyperplasia ( mean area ) assessed by intravascular ultrasonography at 1 year .
METHODS	Secondary endpoints were SVG failure , ectasia ( > 50 % initial diameter ) , and overall uniformity as judged by Fitzgibbon classification .
RESULTS	One-year follow-up angiography was completed in 29 patients ( 96.6 % ) .
RESULTS	All internal mammary artery grafts were patent .
RESULTS	Overall SVG failure rates did not differ significantly between the two groups ( 30 % stented versus 28.2 % nonstented SVG , p = 0.55 ) .
RESULTS	The SVG mean intimal hyperplasia area , assessed in 43 SVGs , was significantly reduced in the stented group ( 4.37 1.40 mm ( 2 ) ) versus nonstented group ( 5.12 1.35 mm ( 2 ) , p = 0.04 ) .
RESULTS	In addition , stented SVGs demonstrated marginally significant improvement in lumen uniformity ( p = 0.08 ) and less ectasia ( 6.7 % versus 28.2 % , p = 0.05 ) .
RESULTS	There was some evidence that ligation of side branches with metallic clips increased SVG failure in the stented group .
CONCLUSIONS	External stenting has the potential to improve SVG lumen uniformity and reduce diffuse intimal hyperplasia 1 year after coronary artery bypass graft surgery .

###24435244
BACKGROUND	This study aims at investigating the effect of a single pre-operative oral administration of morphine sulphate ( Oramorph ) on pain after laparoscopic cholecystectomy ( LC ) .
METHODS	Forty-one ASA I-III patients , aged 18-65 years , undergoing LC were randomly , double-blindly allocated to treatment ( N. = 20 , 30mg Oramorph , group M ) or placebo ( N. = 21 , group P ) .
METHODS	General anesthesia was maintained with propofol and remifentanil .
METHODS	All patients received ketamine 0.2 mg/kg iv at induction , intraoperative ketorolac 30mg iv and tramadol postoperatively ( iv PCA : bolus 50 mg , lock-out 30 min , max 100 mg/4 hours ) .
METHODS	Numerical rating scale for pain ( NRS ) , White 's fast track and PADSS scores , tramadol consumption and adverse events were recorded for the first 24h .
METHODS	All patients underwent State Trait Anxiety Inventory ( STAI ) and Mini Mental State Examination ( MMSE ) .
RESULTS	Anthropometric characteristics , MMSE , STAI , ASA status , NRS rest , White 's and PADDS scores , PONV incidence were similar .
RESULTS	Group M showed significantly lower NRS on movement during the first 3 hours after awakening .
RESULTS	Cumulative tramadol consumption was lower in group M than in group P ( 185142 mg versus 263199 mg , P = 0.199 ) .
CONCLUSIONS	Within a multimodal approach , a single preoperative oral administration of 30 mg of morphine sulphate in patients undergoing LC did not improve pain at rest , but improved NRS on movement during the first 3 hours after awakening .
CONCLUSIONS	Group P required a higher mean dose of tramadol compared to Group M , although not significantly .
CONCLUSIONS	The safety profile of Oramorph allowed fast extubation and awakening times as well as prompt home discharge within 6 hours from surgery .

###25323601
OBJECTIVE	Further survival benefits may be gained from low-dose chest computed tomography ( CT ) by assessing vertebral fractures and bone density .
OBJECTIVE	We sought to assess the association between CT-measured vertebral fractures and bone density with all-cause mortality in lung cancer screening participants .
METHODS	Following a case-cohort design , lung cancer screening trial participants ( N = 3,673 ) who died ( N = 196 ) during a median follow-up of 6 years ( inter-quartile range : 5.7-6 .3 ) were identified and added to a random sample of N = 383 from the trial .
METHODS	We assessed vertebral fractures using Genant 's semiquantative method on sagittal reconstructions and measured bone density ( Hounsfield Units ( HU ) ) in vertebrae .
METHODS	Cox proportional hazards modelling was used to determine if vertebral fractures or bone density were independently predictive of mortality .
RESULTS	The prevalence of vertebral fractures was 35 % ( 95 % confidence interval 30-40 % ) among survivors and 51 % ( 44-58 % ) amongst cases .
RESULTS	After adjusting for age , gender , smoking status , pack years smoked , coronary and aortic calcium volume and pulmonary emphysema , the adjusted hazard ratio ( HR ) for vertebral fracture was 2.04 ( 1.43-2 .92 ) .
RESULTS	For each 10 HU decline in trabecular bone density , the adjusted HR was 1.08 ( 1.02-1 .15 ) .
CONCLUSIONS	Vertebral fractures and bone density are independently associated with all-cause mortality .
CONCLUSIONS	Lung cancer screening chest computed tomography contains additional , potentially useful information .
CONCLUSIONS	Vertebral fractures and bone density are independently predictive of mortality .
CONCLUSIONS	This finding has implications for screening and management decisions .

###25002196
BACKGROUND	Irritable bowel syndrome ( IBS ) is a common gastrointestinal functional disorder with no effective therapy .
BACKGROUND	Traditional Chinese medicine ( TCM ) is one of the most common complementary therapies in China .
BACKGROUND	We designed this study to evaluate the efficacy and safety of Shun-Qi-Tong-Xie Granule ( SQTX Granule ) , a TCM treatment , in patients with IBS with diarrhea ( IBS-D ) .
METHODS	A randomised , double-blinded , placebo-controlled , multi-centre , superiority clinical trial to evaluate the efficacy and safety of SQTX Granule is proposed .
METHODS	Eligible patients ( Rome III ) with IBD-S will be randomly assigned into SQTX Granule group and the placebo group .
METHODS	Patients will receive a 28-day treatment and a 2-month follow-up .
METHODS	The primary outcome measures include the scores of IBS-quality of life ( IBS-QOL ) rating scale and IBS-symptom severity scale ( IBS-SSS ) rating scale .
METHODS	The secondary outcome measures include the improvement of symptom scores , and the duration of abdominal pain and diarrhea .
CONCLUSIONS	According to TCM theory , SQTX Granule has a regulating effect on abdominal pain , diarrhea and the syndrome of liver-spleen disharmony , which is similar to the symptoms of IBS-D .
CONCLUSIONS	This study will provide objective evidence to evaluate the efficiency and safety of SQTX Granule in IBS-D treatment .
BACKGROUND	ChiCTR-TRC-14004241 .
BACKGROUND	Date of registration : 9 February 2014 .

###25790670
OBJECTIVE	To explore changes of B and T lymphocyte attenuator ( BTLA ) , superoxide dismutase ( SOD ) , catalase ( CAT ) , total antioxidant capacity ( TAOC ) , reactive oxygen species ( ROS ) , reactive nitrogen species ( RNS ) , malondialdehyde ( MDA ) in ankylosing spondylitis ( AS ) patients , and the effect of Xinfeng Capsule ( XFC ) on them .
METHODS	Totally 120 AS patients were assigned to two groups according to random digit table method , the XFC group ( 3 XFC pills each time , 3 times a day ) and the SASP group ( 4 SASP tablets each time , twice a day ) , 60 in each group .
METHODS	All patients were treated for 3 months .
METHODS	Another 60 healthy subjects were recruited as a healthy control group .
METHODS	The expression frequency and activation levels of BTLA were detected using flow cytometry .
METHODS	Serum oxidative stress indices ( such as SOD and CAT , TAOC , ROS , RNS , MDA ) and contents of cytokines [ tumor necrosis factor ( TNF - ) , IL-1 , IL-4 , and IL-10 ] were detected using enzyme-linked immunoassay ( ELISA ) .
METHODS	Erythrocyte sedimentation rate ( ESR ) was detected using Westergren method .
METHODS	High-sensitivity C-reactive protein ( Hs-CRP ) was detected using HITACHI 7060 type automatic biochemical analyzer .
METHODS	Clinical efficacies of ASAS 20 and BASDAI50 were assessed using VAS .
METHODS	Correlation analysis between scoring for quality of life and BTLA expression frequency was performed .
RESULTS	( 1 ) Clinical efficacies of ASAS 20 and BASDAI50 were significantly better in the XFC group than in the SASP group ( P < 0.01 ) .
RESULTS	( 2 ) Compared with the healthy control group , BTLA expressions in the peripheral blood of AS patients decreased significantly ( P < 0.05 ) ; SOD , CAT , and TAOC values significantly decreased ( P < 0.01 , P < 0.05 ) ; ROS , RNS , and MDA values significantly increased ( P < 0.01 , P < 0.05 ) ; TNF - , IL-1 , ESR , and Hs-CRP values significantly increased ( P < 0.01 ) ; IL-4 and IL-10 values decreased significantly ( P < 0.01 , P < 0.05 ) .
RESULTS	( 3 ) Compared with pre-treatment in the same group , BTLA/CD19 + B , BTLA/CD24 + B , SOD , TAOC , IL-4 , SF-36 [ physical functioning ( PF ) , social functioning ( SF ) , role limitation due to physical problems ( RP ) , role limitation due to emotional problems ( RE ) , body pain ( BP ) , mental health ( MH ) , vitality ( VT ) , general health ( GH ) ] were significantly elevated ; ROS , MDA , TNF - , ESR , Hs - CRP , VAS , BASDAI and BASFI , BAS-G were significantly lower in the peripheral blood of the two groups after treatment ( P < 0.01 , P < 0.05 ) .
RESULTS	Better effect was shown in the XFC group in elevating BTLA/CD19 + B , BTLA/CD24 + B , SOD , TAOC , IL-10 , BP , MH , VT , and SF ; and lowering ROS , IL-1 , MDA , TNF - , ESR , Hs-CRP , VAS , BASDAI , BASFI , and BAS-G ( P < 0.01 , P < 0.05 ) .
RESULTS	( 4 ) Pearson correlation analysis showed , BTLA/CD19 + B expression of the peripheral blood was positively correlated with SOD , CAT , TAOC , IL-4 , IL-10 , GH , RP , BP , and SF ( r = 0.431 , 0.325 , 0.318 , 0.316 , 0.348 , 0.314 , 0.358 , 0.318 , 0.326 , respectively , P < 0.05 , P < 0.01 ) , while it was negative correlated with ROS , MDA , TNF - , IL-1 , ESR , VAS , and BASDAI ( r = -0.342 , -0.368 , -0.334 , -0.354 , -0.324 , -0.372 , -0.342 , respectively , P < 0.05 , P < 0.01 ) .
RESULTS	BTLA/CD24 B expression of the peripheral blood was positively correlated with SOD , TAOC , IL-4 , IL-10 , GH , RP , BP , SF , RE , MH , VT ( r = 0.358 , 0.352 , 0.372 , 0.436 , 0.435 , 0.326 , 0.352 , 0.345 , 0.326 , 0.343 , 0.332 , respectively , P < 0.05 , P < 0.01 ) , while it was negative correlated with ROS , RNS , MDA , ESR , Hs-CRP , VAS , BASDAI , and BASFI ( r = -0.447 , -0.336 , -0.405 , -0.395 , -0.358 , -0.436 , -0.338 , -0.425 , respectively , P < 0.05 , P < 0.01 ) .
CONCLUSIONS	XFC could improve BTLA expression in the peripheral blood of AS patients , negatively regulate activation and proliferation of B cells , and reduce abnormal immune responses and oxidative stress injury , thereby effectively alleviating joint stiffness and pain .

###24796042
OBJECTIVE	To evaluate the impacts on the short-term efficacy and the long-term prevention of recurrence of allergic rhinitis treated with the triple-strong stimulation at Dazhui ( GV 14 ) so as to provide the convenient and long-term effective therapy of acupuncture and moxibustion for allergic rhinitis .
METHODS	One hundred and twenty cases of allergic rhinitis were randomized into an acupuncture group , an acupuncture + medication group and a triple-strong stimulation group , 40 cases in each one .
METHODS	In the acupuncture group , acupuncture was applied at Dazhui ( GV 14 ) , Fengchi ( GB 20 ) , Baihui ( GV 20 ) , Yintang ( GV 29 ) and the others , stimulating with reinforcing manipulation for the deficiency and reducing manipulation for the excess , once every day .
METHODS	In the acupuncture + medication group , on the basis of acupuncture therapy , claritin ( loratadine tablets ) was supplemented for oral administration , 10 mg , once every two days , continuously for 30 days .
METHODS	In the triple-strong stimulation group , on the basis of acupuncture therapy , the strong needling , strong cupping and strong moxibustion were applied at Dazhui ( GV 14 ) .
METHODS	This combined therapy was given once every day in the first 3 days and once every two days afterwards .
METHODS	The 10 day treatment made one session , at the interval of 3 days between the sessions and totally 3 sessions were required in the three groups .
METHODS	Separately , before treatment , after treatment and in 6 months after treatment , the changes of symptom and physical sign score and value of single item symptom including nasal itching , nasal blockage , sneezing and rhinorrhea were observed in the patients of the three groups .
METHODS	And the long-term clinical efficacy was compared among the three groups .
RESULTS	The symptom and physical sign score and the value of single item symptom were all reduced in the three groups after treatment and in 6 months after treatment ( P < 0.001 , P < 0.01 , P < 0.05 ) .
RESULTS	The results in the triple-strong stimulation group were superior to the other two groups ( all P < 0.05 ) .
RESULTS	In the triple-strong stimulation group , the total effective rate was 92.5 % ( 36/40 ) in the follow-up of 6 months after treatment , which was better than 60.5 % ( 23/38 ) in the acupuncture group and 69.2 % ( 27/39 ) in the acupuncture + medication group ( both P < 0.01 ) .
CONCLUSIONS	The combined therapy of acupuncture and the triple-strong stimulation at Dazhui ( GV 14 ) achieves the reliable and effective result in the clinical treatment of allergic rhinitis and displays the good role on the prevention from long-term recurrence .

###24417563
OBJECTIVE	To analyse change in selected bone markers in peri-implant sulcus fluid ( PISF ) sampled before treatment and after 12 months and test correlation with change in disease progression .
METHODS	Peri-implant sulcus fluid was sampled from 32 patients in a randomized , clinical study comparing peri-implant defect re-construction with or without porous titanium granules .
METHODS	Matrix metalloproteinase 8 levels were measured using the Quantikine Human Total MMP-8 ( DMP800 ) ELISA .
METHODS	Multianalyte profiling of the level of bone markers [ interleukin-6 , osteprotegerin ( OPG ) , osteocalcin , leptin , osteopontin , parathyroid hormone , tumour necrosis factor - , adiponectin and insulin ] was performed by Luminex using Human Bone Panel IB .
METHODS	Changes in bone marker levels were compared and correlation with clinical findings was tested .
RESULTS	No differences in clinical parameter or bone marker levels between test and control group were found .
RESULTS	When comparing bone marker levels irrespective of treatment allocation between baseline and 12 months , a significant reduction in total protein , matrix metalloproteinase -8 , interleukin-6 , OPG , leptin and adiponectin were demonstrated .
RESULTS	Positive correlations were found between the reduction in interleukin-6 ( r = 0.43 ) , insulin ( r = 0.38 ) and matrix metalloproteinase-8 ( r = 0.47 ) concentration , and probing pocket depth reduction .
CONCLUSIONS	Peri-implantitis surgical treatment induced some reduction of the studied bone markers .
CONCLUSIONS	Conclusive evidence for correlation between change in bone marker concentrations with disease resolution was not found .

###25228478
BACKGROUND	Screening of natural compounds for the development of anti-acne therapeutic agents has been steadily required considering various side effects of acne medications .
BACKGROUND	However , previous studies have mainly focused on experimental tests without clinical trials and histopathological analysis .
OBJECTIVE	To compare the clinical efficacy , safety and histopathological changes between Lactobacillus-fermented Chamaecyparis obtusa ( LFCO ) and existing tea tree oil ( TTO ) .
METHODS	A total of 34 patients were instructed to apply 5 % LFCO to the involved areas of a randomly allocated side and 5 % TTO extract to the other side for 8 weeks in a double-blind split-face clinical trial .
RESULTS	After 8 weeks , inflammatory acne lesions were reduced by 65.3 % on the LFCO side and by 38.2 % on the TTO side .
RESULTS	LFCO was also superior to TTO in the onset time of efficacy ( p < 0.05 ) .
RESULTS	The LFCO side further demonstrated improvement for non-inflammatory lesions ( 52.6 % , p < 0.05 ) , decreased size of sebaceous glands and sebum output reductions .
RESULTS	Patients ' subjective satisfaction was also higher without severe adverse reactions .
RESULTS	Protein expressions of nuclear factor B decreased earlier on the LFCO side , and those of interleukin-1 ( IL-1 ) , IL-8 , insulin-like growth factor 1 receptor and sterol regulatory element-binding protein 1 decreased subsequently .
RESULTS	Ultra-performance liquid chromatography/high-resolution mass spectrometry further demonstrated that the contents of dihydroxybenzoic acid , taxifolin and quercetin were increased in LFCO after fermentation .
CONCLUSIONS	LFCO treatment was rapid and effective for treating acne lesions compared to TTO .
CONCLUSIONS	Histopathological findings correlated well with the clinical acne grade and treatment response .
CONCLUSIONS	This novel natural compound appears to be effective and safe for acne treatment .

###24731903
OBJECTIVE	This study aims to investigate the possible differences in skin temperature and blood perfusion changes between single and triple moxibustion .
METHODS	Thirty healthy volunteers were randomly divided into two groups : a triple moxibustion group ( n = 15 ) received indirect moxibustion on CV12 for 30min and a single moxibustion group ( n = 15 ) for 10min .
METHODS	After 10min of bed rest , skin temperature and blood perfusion were measured by digital infrared thermal imaging and laser Doppler perfusion imaging eight times in total , pre-moxibustion and 0 , 5 , 10 , 15 , 20 , 25 and 30min post moxibustion .
METHODS	The changes in the skin temperature and blood perfusion in an area 5cm in diameter around CV12 at 0min post treatment compared to baseline was the main outcome measurement .
RESULTS	The difference of changes in skin temperature and blood perfusion on CV12 between the two groups remained statistically significant for 30min in an area 5cm in diameter around CV12 and for 25min in a 15-cm-diameter area .
RESULTS	No adverse events were reported .
CONCLUSIONS	Triple moxibustion with large , indirect moxa appeared to induce greater increases in skin temperature and blood perfusion than single moxibustion .

###25453412
BACKGROUND	Published correlations between histological abnormalities and right ventricular ( RV ) function , as evaluated by speckle tracking echocardiography ( STE ) , are scarce in patients with tetralogy of Fallot ( TOF ) .
BACKGROUND	The purpose of the study is to assess age-associated differences in the effect of RV myocardial remodeling on ventricular function in patients with TOF .
METHODS	Operatively resected crista supraventricularis muscle from 30 patients ( median age 12months ) undergoing intracardiac repair of TOF were studied by light microscopy .
METHODS	The patients were divided into younger ( age at surgery 12months ) and older ( age at surgery > 12months ) subgroups .
METHODS	The RV global longitudinal peak systolic strain ( GLS ) , strain rate ( GLSRs ) and early diastolic strain rate ( GLSRe ) were measured by two-dimensional STE before and 6months after repair .
RESULTS	The histopathological data revealed hypertrophy of the cardiomyocytes , a thickened endocardium , and increased interstitial and perivascular collagen in RV , which were associated with older age at the time of repair .
RESULTS	The RV global systolic and diastolic functions in patients with repaired TOF were increased compared with the preoperative values .
RESULTS	The RV cardiomyocyte diameter and collagen volume fraction ( CVF ) correlated with the preoperative GLS , GLSRs and GLSRe , respectively , in the younger patients ( r1 = -0.566 , P1 = 0.018 ; r2 = -0.493 , P2 = 0.004 ; r3 = -0.504 , P3 = 0.039 ) .
RESULTS	The RV cardiomyocyte diameter and CVF correlated with preoperative GLS , GLSRs and GLSRe , respectively , in the older patients ( r1 = -737 , P1 = 0.004 ; r2 = -0.588 , P2 = 0.035 ; r3 = -0.812 , P3 = 0.001 ) .
RESULTS	The correlation of the RV cardiomyocyte diameter with the postoperative GLS and GLSRe ( r1 = -665 , P1 = 0.036 ; r2 = -0.787 , P2 = 0.007 ) and the CVF with the postoperative GLSRs and GLSRe ( r1 = -762 , P1 = 0.002 ; r2 = -0.713 , P2 = 0.004 ) were identified only in the older patients .
RESULTS	Multivariate analysis indicated that the age at repair was an independent predictor of postoperative GLSRs and GLSRe in all of the patients ( = -0.449 , P = 0.041 ; = -0.607 , P = 0.004 ) .
CONCLUSIONS	The effect of RV myocardial remodeling on preoperative RV function was more pronounced in the older patients with TOF than in the younger ones .
CONCLUSIONS	Preoperative myocardial remodeling affected the postoperative RV function in the older but not in the younger patients .
CONCLUSIONS	The age at the time of surgical repair was the independent determinant of the postoperative RV myocardial function .

###24324084
OBJECTIVE	While meta-analyses and clinical trials show improved survival in advanced NSCLC treated with platinum-containing chemotherapy , there are few data concerning front-line platinum-free ifosfamide-based regimens .
OBJECTIVE	We aimed to compare cisplatin-based chemotherapy to ifosfamide-gemcitabine ( IG ) with pre-defined second-line docetaxel .
METHODS	693 Untreated advanced inoperable NSCLC cases were randomised to either GIP ( gemcitabine , ifosfamide , cisplatin ) , DP ( docetaxel , cisplatin ) or IG .
METHODS	Primary outcome was overall survival .
RESULTS	Median age of the patients was 58 years with a predominance of males ( 75 % ) , adenocarcinoma ( 56 % ) , Karnofsky PS 80-100 ( 77 % ) and stage-IV disease ( 81 % ) .
RESULTS	Median survival times were 8.7 , 8.8 and 8.3 months for IG , GIP and DP ( p = 0.79 ) .
RESULTS	GIP presented with ( p < 0.05 ) greater neutropenia , thrombopenia , vomiting , while greater cardiotoxicity , diarrhea , peripheral neuropathy were observed for DP and encephalopathy for IG .
CONCLUSIONS	In advanced NSCLC , cisplatin-based CT is not superior to a platinum-free regimen ( ifosfamide-gemcitabine ) with a favourable toxicity profile .

###24351572
OBJECTIVE	The aim of this study was to compare the antiinflammatory effect and ocular surface toxicity of topical nonpreserved methylprednisolone sodium succinate 1 % and preserved prednisolone acetate suspension 1 % for the management of acute anterior uveitis ( AAU ) .
METHODS	In this prospective , randomized , investigator-masked , comparative clinical trial , patients with mild-to-moderate noninfectious AAU were assigned randomly to receive either hourly nonpreserved methylprednisolone 1 % ( group A ) or preserved prednisolone 1 % ( group B ) eye drops followed by a 2-week tapering regimen .
METHODS	Anterior chamber cells and flare were clinically evaluated for the objective comparison of the antiinflammatory effect .
METHODS	The main outcome measure was the percentage of patients with a resolution of inflammation ( anterior chamber cells < 1 + ) on day 14 .
METHODS	Ocular surface toxicity was assessed by means of the corneal fluorescein staining score , tear breakup time , Schirmer I test , and questionnaire-based grading of ocular discomfort parameters .
RESULTS	Seventy-two eyes of 68 patients were studied , of which 38 eyes were enrolled in group A and 34 eyes were enrolled in group B. On day 14 , 76.3 % of the patients in group A had resolution of inflammation compared with 70.6 % of the patients in group B , proving noninferiority ( = 0.303 , P = 0.582 ) .
RESULTS	The mean anterior chamber cell grade reduction for patients in group A was similar to that in group B ( 2.52 vs. 2.86 , respectively ; P = 0.92 ) .
RESULTS	Group A patients showed significantly lower corneal fluorescein staining scores ( P < 0.001 ) and reported milder subjective ocular discomfort ( 0.55 vs. 1.43 , P = 0.01 ) as compared with group B.
CONCLUSIONS	Both preparations demonstrated equal antiinflammatory effects for the treatment of AAU .
CONCLUSIONS	Nonpreserved methylprednisolone eye drops exhibited a significantly lower ocular surface toxicity profile and milder subjective discomfort when compared with that exhibited by preserved prednisolone .

###24655936
OBJECTIVE	To determine whether 30 head-down tilt ( HDT ) used for secretion clearance is safe for acute trauma patients .
BACKGROUND	There are concerns that HDT may lead to cardiac irregularities in intubated patients in the ICU .
METHODS	Eleven mechanically ventilated trauma patients ( 25-42 yrs ) without cardiovascular problems received two interventions , one supine HDT for 10 min and a control in the horizontal supine position ( HS ) , in a crossover design .
RESULTS	Compared to baseline there were statistically significant ( p < 0.05 ) increases in SBP ( 6.3 mm Hg ; 95 % CI 2.5 , 12.7 ) and CVP ( 7.3 cm H2O ; 5.7 , 10.0 ) during 10 min HDT although these were not of clinical concern .
RESULTS	Heart rate and oxygen saturation were unchanged .
RESULTS	No episodes of arrhythmia or hypoxemia were observed .
RESULTS	All values returned close to baseline during 10 min horizontal recovery .
RESULTS	There were no significant changes during the control HS intervention .
CONCLUSIONS	30 HDT entails minimal risk for trauma patients who have no underlying cardiovascular disease .

###25302456
OBJECTIVE	To examine whether or not the combination of diclofenac suppository with peri-prostatic nerve block ( PPNB ) was effective in reducing the degree of pain experienced during transrectal ultrasound ( TRUS ) - guided prostate biopsy in a randomised single-blind placebo-controlled trial .
METHODS	In all , 96 patients having a planned TRUS-guided prostate biopsy were randomised into one of the following arms on a 1:1 basis : 10mL 1 % lignocaine PPNB and placebo suppository ( control ) or 10mL 1 % lignocaine PPNB and 100mg diclofenac suppository ( treatment ) .
METHODS	Pain scores were recorded using the Numerical Rating Scale for pain ( 0-10 ) at the following time-points : ( i ) introduction of probe , ( ii ) during biopsy , ( iii ) 1h after biopsy , ( iv ) later that evening ( 6h after biopsy ) and ( v ) 1 day after biopsy .
METHODS	Patients were asked about their preferred method for pain control if a repeat TRUS-guided prostate biopsy was required : local anaesthetic ( LA ) again or intravenous sedation .
RESULTS	There were no significant differences in age ( P = 0.653 ) or PSA level ( P = 0.584 ) between either study arm .
RESULTS	The differences in pain scores between the control and treatment groups were not significant at Time 1 ( probe insertion ; P = 0.299 ) , Time 2 ( biopsy ; P = 0.983 ) , Time 4 ( evening after ; P = 0.231 ) and Time 5 ( 1 day after biopsy ; P = 0.384 ) .
RESULTS	At Time 3 ( 1h after biopsy ) , the control pain scale scores were statistically significantly higher than the treatment pain scale scores ( P = 0.044 ) .
RESULTS	There was no difference between treatment ( 87 % ) and control ( 80 % ) groups as to whether they would prefer to repeat the biopsy under LA ( P = 0.373 ) .
CONCLUSIONS	The use of a diclofenac suppository with PPNB did not show any clinically meaningful effect in decreasing pain or improving tolerability of TRUS-guided prostate biopsy and is not recommended .
CONCLUSIONS	PPNB TRUS-guided biopsy is extremely well tolerated , with > 80 % of patients electing for subsequent LA biopsy if required .

###25670362
BACKGROUND	In the Determining the Efficacy and Tolerability of cholesteryl ester transfer protein ( CETP ) INhibition with AnacEtrapib ( DEFINE ) trial , anacetrapib added to statin produced robust low-density lipoprotein cholesterol ( LDL-C ) - lowering and high-density lipoprotein cholesterol ( HDL-C ) - raising vs placebo in patients with coronary heart disease ( CHD ) .
BACKGROUND	Predictors of the degree of LDL-C and HDL-C responses to anacetrapib , however , are poorly understood .
OBJECTIVE	Lipid effects of anacetrapib in patient subgroups within the DEFINE trial ( clinicaltrials.gov : NCT00685776 ) are reported .
METHODS	The percent of placebo-corrected changes from baseline for LDL-C ( estimated by Friedewald calculation [ Fc-LDL-C ] ) and HDL-C after 24weeks of anacetrapib 100mg/day were compared among patients by age , gender , race , diabetes status , type of concomitant statin with or without other lipid therapies , and baseline HDL-C , Fc-LDL-C , and triglyceride ( TG ) levels .
RESULTS	Percent decreases in Fc-LDL-C and increases in HDL-C with anacetrapib were similar ( magnitude of difference generally < 1/5 of the overall treatment effect ) across subgroups by age , gender , diabetes status , lipid-modifying regimen , and baseline Fc-LDL-C , HDL-C , or TG .
RESULTS	On the other hand , anacetrapib effects on Fc-LDL-C ( -24 % vs -41 % ) and HDL-C ( +75 % vs +139 % ) appeared to be less in black vs white patients , respectively .
CONCLUSIONS	Effects of anacetrapib on Fc-LDL-C and HDL-C were generally comparable across subgroups , including being relatively independent of baseline Fc-LDL-C , HDL-C , or TG levels .
CONCLUSIONS	The clinical impact of the lipid-modifying effects of anacetrapib is being evaluated in the cardiovascular disease outcomes trial , Randomized EValuation of the Effects of Anacetrapib though Lipid-modification ( REVEAL ) .

###25580725
OBJECTIVE	Three months of a once-weekly combination of rifapentine and isoniazid for treatment of latent tuberculosis infection is safe and effective for persons 12 years or older .
OBJECTIVE	Published data for children are limited .
OBJECTIVE	To compare treatment safety and assess noninferiority treatment effectiveness of combination therapy with rifapentine and isoniazid vs 9 months of isoniazid treatment for latent tuberculosis infection in children .
METHODS	A pediatric cohort nested within a randomized , open-label clinical trial conducted from June 11 , 2001 , through December 17 , 2010 , with follow-up through September 5 , 2013 , in 29 study sites in the United States , Canada , Brazil , Hong Kong ( China ) , and Spain .
METHODS	Participants were children ( aged 2-17 years ) who were eligible for treatment of latent tuberculosis infection .
METHODS	Twelve once-weekly doses of the combination drugs , given with supervision by a health care professional , for 3 months vs 270 daily doses of isoniazid , without supervision by a health care professional , for 9 months .
METHODS	We compared rates of treatment discontinuation because of adverse events ( AEs ) , toxicity grades 1 to 4 , and deaths from any cause .
METHODS	The equivalence margin for the comparison of AE-related discontinuation rates was 5 % .
METHODS	Tuberculosis disease diagnosed within 33 months of enrollment was the main end point for testing effectiveness .
METHODS	The noninferiority margin was 0.75 % .
RESULTS	Of 1058 children enrolled , 905 were eligible for evaluation of effectiveness .
RESULTS	Of 471 in the combination-therapy group , 415 ( 88.1 % ) completed treatment vs 351 of 434 ( 80.9 % ) in the isoniazid-only group ( P = .003 ) .
RESULTS	The 95 % CI for the difference in rates of discontinuation attributed to an AE was -2.6 to 0.1 , which was within the equivalence range .
RESULTS	In the safety population , 3 of 539 participants ( 0.6 % ) who took the combination drugs had a grade 3 AE vs 1 of 493 ( 0.2 % ) who received isoniazid only .
RESULTS	Neither arm had any hepatotoxicity , grade 4 AEs , or treatment-attributed death .
RESULTS	None of the 471 in the combination-therapy group developed tuberculosis vs 3 of 434 ( cumulative rate , 0.74 % ) in the isoniazid-only group , for a difference of -0.74 % and an upper bound of the 95 % CI of the difference of +0.32 % , which met the noninferiority criterion .
CONCLUSIONS	Treatment with the combination of rifapentine and isoniazid was as effective as isoniazid-only treatment for the prevention of tuberculosis in children aged 2 to 17 years .
CONCLUSIONS	The combination-therapy group had a higher treatment completion rate than did the isoniazid-only group and was safe .
BACKGROUND	clinicaltrials.gov Identifier : NCT00023452 .

###25080450
OBJECTIVE	To evaluate the safety and efficacy of daclatasvir , an HCV NS5A inhibitor with pangenotypic activity , administered with peginterferon-alfa-2a / ribavirin .
METHODS	In this Phase 2b double-blind , placebo-controlled study , treatment-naive adults with HCV genotype 1 ( N = 365 ) or 4 ( N = 30 ) infection were randomly assigned ( 2:2:1 ) to daclatasvir 20mg or 60mg , or placebo once daily plus weekly peginterferon-alfa-2a and twice-daily ribavirin .
METHODS	Daclatasvir recipients achieving protocol-defined response ( PDR ; HCV-RNA < lower limit of quantitation at Week 4 and undetectable at Week 10 ) were rerandomised at Week 12 to continue daclatasvir/peginterferon-alfa -2 a/ribavirin for 24weeks total duration or to placebo/peginterferon-alfa -2 a/ribavirin for another 12weeks .
METHODS	Patients without PDR and placebo patients continued peginterferon-alfa/ribavirin through Week 48 .
METHODS	Primary efficacy endpoints were undetectable HCV-RNA at Weeks 4 and 12 ( extended rapid virologic response , eRVR ) and at 24weeks post-treatment ( sustained virologic response , SVR24 ) among genotype 1-infected patients .
RESULTS	Overall , eRVR was achieved by 54.4 % ( 80/147 ) of genotype 1-infected patients receiving daclatasvir 20mg , 54.1 % ( 79/146 ) receiving 60mg versus 13.9 % ( 10/72 ) receiving placebo .
RESULTS	SVR24 was achieved among 87 ( 59.2 % ) , 87 ( 59.6 % ) , and 27 ( 37.5 % ) patients in these groups , respectively .
RESULTS	Higher proportions of genotype 4-infected patients receiving daclatasvir 20mg ( 66.7 % ; 8/12 ) or 60mg ( 100.0 % ; 12/12 ) achieved SVR24 versus placebo ( 50.0 % ; 3/6 ) .
RESULTS	A majority of daclatasvir-treated patients achieved PDR and experienced less virologic failure and higher SVR24 rates with a shortened 24-week treatment duration .
RESULTS	Adverse events occurred with similar frequency across all treatment groups .
CONCLUSIONS	The combination of daclatasvir/peginterferon-alfa/ribavirin was generally well tolerated and achieved higher SVR24 rates compared with placebo/peginterferon-alfa/ribavirin among patients infected with HCV genotype 1 or 4 .
BACKGROUND	NCT01125189 .

###24497661
OBJECTIVE	Examine whether cognitive behavioral therapy for insomnia ( CBT-I ) improves sleep in posttraumatic stress disorder ( PTSD ) as well as nightmares , nonsleep PTSD symptoms , depression symptoms , and psychosocial functioning .
METHODS	RANDOMIZED CONTROLLED TRIAL WITH TWO ARMS : CBT-I and monitor-only waitlist control .
METHODS	Department of Veterans Affairs ( VA ) Medical Center .
METHODS	Forty-five adults ( 31 females : [ mean age 37 y ( 22-59 y ) ] with PTSD meeting research diagnostic criteria for insomnia , randomly assigned to CBT-I ( n = 29 ; 22 females ) or monitor-only waitlist control ( n = 16 ; nine females ) .
METHODS	Eight-session weekly individual CBT-I delivered by a licensed clinical psychologist or a board-certified psychiatrist .
RESULTS	Measures included continuous monitoring of sleep with diary and actigraphy ; prepolysomnography and postpolysomnography and Clinician-Administered PTSD Scale ( CAPS ) ; and pre , mid , and post self-report questionnaires , with follow-up of CBT-I participants 6 mo later .
RESULTS	CBT-I was superior to the waitlist control condition in all sleep diary outcomes and in polysomnography-measured total sleep time .
RESULTS	Compared to waitlist participants , CBT-I participants reported improved subjective sleep ( 41 % full remission versus 0 % ) , disruptive nocturnal behaviors ( based on the Pittsburgh Sleep Quality Index-Addendum ) , and overall work and interpersonal functioning .
RESULTS	These effects were maintained at 6-mo follow-up .
RESULTS	Both CBT-I and waitlist control participants reported reductions in PTSD symptoms and CAPS-measured nightmares .
CONCLUSIONS	Cognitive behavioral therapy for insomnia ( CBT-I ) improved sleep in individuals with posttraumatic stress disorder , with durable gains at 6 mo. .
CONCLUSIONS	Overall psychosocial functioning improved following CBT-I .
CONCLUSIONS	The initial evidence regarding CBT-I and nightmares is promising but further research is needed .
CONCLUSIONS	Results suggest that a comprehensive approach to treatment of posttraumatic stress disorder should include behavioral sleep medicine .
BACKGROUND	TRIAL NAME : Cognitive Behavioral Treatment Of Insomnia In Posttraumatic Stress Disorder .
BACKGROUND	URL : http://clinicaltrials.gov/ct2/show/NCT00881647 .
BACKGROUND	NCT00881647 .

###24979556
BACKGROUND	Irritable bowel syndrome ( IBS ) is a common disorder in Iran with challenging treatment .
BACKGROUND	Although trials have suggested that probiotics alleviate the complaints of patients with minimal side effects , they have not been investigated in Iranian adults .
METHODS	In a randomized double-blind study , 108 eligible IBS patients ( Rome III Criteria ) aged 20 - 70 years who referred consecutively to a clinical center in Tehran with abdominal bloating from 2010 to 2012 received a combination probiotics or placebo twice daily for 4 weeks .
METHODS	The objective was to evaluate the efficacy and safety of a multi-strain probiotics combination .
METHODS	One week prior to and throughout the treatment , the participants recorded their abdominal symptoms on a daily basis , using visual analogue scale and reported satisfactory relief of general symptoms at the end of each week .
METHODS	Adverse events were evaluated by self-reporting and physical examination .
METHODS	Continuous variables were analyzed by independent t-test and chi-square was used for binomials .
RESULTS	The baseline characteristics were balanced ( 60 % female , mean age 36.7 11.5 ) .
RESULTS	A total of 97 ( 51 intervention , 46 control ) completed the treatment .
RESULTS	Intention to treat analysis was done on 108 allocated subjects .
RESULTS	85 % of the probiotic group reported satisfactory relief of general symptoms compared with 47 % in the control group ( P < 0.01 ) .
RESULTS	A reduction in abdominal bloating and pain with probiotic was superior to placebo [ -13.0 vs. -3.7 ( P < 0.01 ) , -8.2 vs. -2.1 ( P = 0.02 ) , respectively ] .
RESULTS	No severe adverse drug reaction was seen in either group .
CONCLUSIONS	A 4-week period of treatment with the combination probiotics twice daily was safe , well tolerated , and effective in our patients .
CONCLUSIONS	Further investigation is recommended for other subgroups of IBS .
CONCLUSIONS	Trial Registration : IRCT.ir IRCT2012071010230N1 .

###24799480
OBJECTIVE	Laparoscopic resection and a multimodal approach known as an enhanced recovery program ( ERP ) have been major changes in colorectal perioperative care that have improved clinical outcomes for colorectal cancer resection .
OBJECTIVE	EnROL ( Enhanced Recovery Open Versus Laparoscopic ) is a multicenter randomized controlled trial examining whether the benefits of laparoscopy still exist when open surgery is optimized within an ERP .
METHODS	Adults with colorectal cancer suitable for elective resection were randomly assigned at a ratio of 1:1 to laparoscopic or open surgery within an ERP , stratified by center , cancer site ( colon v rectum ) , and age group ( < 66 v 66-75 v > 75 years ) using minimization .
METHODS	The primary outcome was physical fatigue at 1 month postsurgery .
METHODS	Secondary outcomes included hospital stay , complications , other patient-reported outcomes ( PROs ) , and physical function .
METHODS	Patients and outcome assessors were blinded until 7 days postsurgery or discharge if earlier .
METHODS	Central independent and blinded pathologic assessment of surgical quality was undertaken .
RESULTS	A total of 204 patients ( laparoscopy , n = 103 ; open surgery , n = 101 ) were recruited from 12 UK centers from July 2008 to April 2012 .
RESULTS	One-month physical fatigue scores were similar in both groups ( mean : laparoscopy , 12.28 ; 95 % CI , 11.37 to 13.19 v open surgery , 12.05 ; 95 % CI , 11.14 to 12.96 ; adjusted mean difference , -0.23 ; 95 % CI , -1.52 to 1.07 ) .
RESULTS	Median total hospital stay was significantly shorter after laparoscopic surgery ( median : laparoscopy , 5 ; interquartile range [ IQR ] , 4 to 9 v open surgery , 7 ; IQR , 5 to 11 days ; P = .033 ) .
RESULTS	There were no differences in other secondary outcomes or in specimen quality after central pathologic review .
CONCLUSIONS	In patients treated by experienced surgeons within an ERP , physical fatigue and other PROs were similar in both groups , but laparoscopic surgery significantly reduced length of hospital stay .

###24722500
OBJECTIVE	This 12-week study assessed the efficacy and tolerability of imeglimin as add-on therapy to the dipeptidyl peptidase-4 inhibitor sitagliptin in patients with type 2 diabetes inadequately controlled with sitagliptin monotherapy .
METHODS	In a multicenter , randomized , double-blind , placebo-controlled , parallel-group study , imeglimin ( 1,500 mg b.i.d. ) or placebo was added to sitagliptin ( 100 mg q.d. ) over 12 weeks in 170 patients with type 2 diabetes ( mean age 56.8 years ; BMI 32.2 kg/m ( 2 ) ) that was inadequately controlled with sitagliptin alone ( A1C 7.5 % ) during a 12-week run-in period .
METHODS	The primary efficacy end point was the change in A1C from baseline versus placebo ; secondary end points included corresponding changes in fasting plasma glucose ( FPG ) levels , stratification by baseline A1C , and percentage of A1C responders .
RESULTS	Imeglimin reduced A1C levels ( least-squares mean difference ) from baseline ( 8.5 % ) by 0.60 % compared with an increase of 0.12 % with placebo ( between-group difference 0.72 % , P < 0.001 ) .
RESULTS	The corresponding changes in FPG were -0.93 mmol/L with imeglimin vs. -0.11 mmol/L with placebo ( P = 0.014 ) .
RESULTS	With imeglimin , the A1C level decreased by 0.5 % in 54.3 % of subjects vs. 21.6 % with placebo ( P < 0.001 ) , and 19.8 % of subjects receiving imeglimin achieved a decrease in A1C level of 7 % compared with subjects receiving placebo ( 1.1 % ) ( P = 0.004 ) .
RESULTS	Imeglimin was generally well tolerated , with a safety profile comparable to placebo and no related treatment-emergent adverse events .
CONCLUSIONS	Imeglimin demonstrated incremental efficacy benefits as add-on therapy to sitagliptin , with comparable tolerability to placebo , highlighting the potential for imeglimin to complement other oral antihyperglycemic therapies .

###25047900
BACKGROUND	There is a need for effective population-based physical activity interventions .
BACKGROUND	The internet provides a good platform to deliver physical activity interventions and reach large numbers of people at low cost .
BACKGROUND	Personalised advice in web-based physical activity interventions has shown to improve engagement and behavioural outcomes , though it is unclear if the effectiveness of such interventions may further be improved when providing brief video-based coaching sessions with participants .
BACKGROUND	The purpose of this study is to determine the effectiveness , in terms of engagement , retention , satisfaction and physical activity changes , of a web-based and computer-tailored physical activity intervention with and without the addition of a brief video-based coaching session in comparison to a control group .
METHODS	Participants will be randomly assigned to one of three groups ( tailoring + online video-coaching , tailoring-only and wait-list control ) .
METHODS	The tailoring + video-coaching participants will receive a computer-tailored web-based physical activity intervention ( ` My Activity Coach ' ) with brief coaching sessions with a physical activity expert over an online video calling program ( e.g. Skype ) .
METHODS	The tailoring-only participants will receive the intervention but not the counselling sessions .
METHODS	The primary time point 's for outcome assessment will be immediately post intervention ( week 9 ) .
METHODS	The secondary time points will be at 6 and 12months post-baseline .
METHODS	The primary outcome , physical activity change , will be assessed via the Active Australia Questionnaire ( AAQ ) .
METHODS	Secondary outcome measures include correlates of physical activity ( mediators and moderators ) , quality of life ( measured via the SF-12v2 ) , participant satisfaction , engagement ( using web-site user statistics ) and study retention .
CONCLUSIONS	Study findings will inform researchers and practitioners about the feasibility and effectiveness of brief online video-coaching sessions in combination with computer-tailored physical activity advice .
CONCLUSIONS	This may increase intervention effectiveness at an acceptable cost and will inform the development of future web-based physical activity interventions .
BACKGROUND	ACTRN12614000339651Date : 31/03/2014 .

###26044872
BACKGROUND	Asthma exacerbations lead to frequent emergency visits and hospitalizations , and are associated with high morbidity and occasionally mortality .
BACKGROUND	New therapeutic strategies are needed .
BACKGROUND	We sought to investigate whether the addition of high-dose inhaled budesonide to standard therapy would shorten the length of stay ( LOS ) in hospital of children admitted for asthma exacerbations .
METHODS	The study was designed as a single-center , double-blind , placebo-controlled and parallel-group trial .
METHODS	Children aged 7-72 months and admitted with an asthma exacerbation clinical asthma score ( CAS ) of between 3 and 9 were allocated to either the budesonide ( n = 50 ) or the placebo ( n = 50 ) group .
METHODS	Hospital LOS was compared between children who received 2 mg/day of budesonide versus placebo in addition to standard management of asthma exacerbation involving oxygen inhalation and 2-agonist , anticholinergic and oral corticosteroid therapy .
METHODS	All patients were assessed every 4 h. Children with a CAS < 3 , a peripheral oxygen saturation > 95 % and normal pulmonary function , and those with a symptom-free period of at least 4 h after salbutamol treatment were discharged .
RESULTS	Total hospital LOS was significantly shorter in the budesonide group than in the placebo group ( median : 44 vs. 80 h , respectively ; p = 0.01 ) .
RESULTS	When compared with placebo , the number of inpatients was significantly less in the budesonide group at all the assessed end points ( Kaplan-Meier ; p = 0.022 ) .
RESULTS	Additionally , nebulized budesonide was found to reduce the overall cost of treatment .
CONCLUSIONS	We demonstrated that , for children hospitalized for asthma exacerbations , an additional 2 mg/day of nebulized budesonide significantly reduced hospital LOS as well as the overall cost of treatment .

###24668102
OBJECTIVE	Barrett esophagus containing low-grade dysplasia is associated with an increased risk of developing esophageal adenocarcinoma , a cancer with a rapidly increasing incidence in the western world .
OBJECTIVE	To investigate whether endoscopic radiofrequency ablation could decrease the rate of neoplastic progression .
METHODS	Multicenter randomized clinical trial that enrolled 136 patients with a confirmed diagnosis of Barrett esophagus containing low-grade dysplasia at 9 European sites between June 2007 and June 2011 .
METHODS	Patient follow-up ended May 2013 .
METHODS	Eligible patients were randomly assigned in a 1:1 ratio to either endoscopic treatment with radiofrequency ablation ( ablation ) or endoscopic surveillance ( control ) .
METHODS	Ablation was performed with the balloon device for circumferential ablation of the esophagus or the focal device for targeted ablation , with a maximum of 5 sessions allowed .
METHODS	The primary outcome was neoplastic progression to high-grade dysplasia or adenocarcinoma during a 3-year follow-up since randomization .
METHODS	Secondary outcomes were complete eradication of dysplasia and intestinal metaplasia and adverse events .
RESULTS	Sixty-eight patients were randomized to receive ablation and 68 to receive control .
RESULTS	Ablation reduced the risk of progression to high-grade dysplasia or adenocarcinoma by 25.0 % ( 1.5 % for ablation vs 26.5 % for control ; 95 % CI , 14.1 % -35.9 % ; P < .001 ) and the risk of progression to adenocarcinoma by 7.4 % ( 1.5 % for ablation vs 8.8 % for control ; 95 % CI , 0 % -14.7 % ; P = .03 ) .
RESULTS	Among patients in the ablation group , complete eradication occurred in 92.6 % for dysplasia and 88.2 % for intestinal metaplasia compared with 27.9 % for dysplasia and 0.0 % for intestinal metaplasia among patients in the control group ( P < .001 ) .
RESULTS	Treatment-related adverse events occurred in 19.1 % of patients receiving ablation ( P < .001 ) .
RESULTS	The most common adverse event was stricture , occurring in 8 patients receiving ablation ( 11.8 % ) , all resolved by endoscopic dilation ( median , 1 session ) .
RESULTS	The data and safety monitoring board recommended early termination of the trial due to superiority of ablation for the primary outcome and the potential for patient safety issues if the trial continued .
CONCLUSIONS	In this randomized trial of patients with Barrett esophagus and a confirmed diagnosis of low-grade dysplasia , radiofrequency ablation resulted in a reduced risk of neoplastic progression over 3 years of follow-up .
BACKGROUND	trialregister.nl Identifier : NTR1198 .

###24748338
OBJECTIVE	The aim of this study was to compare the efficiency of dopamine agonist , Cabergoline , in decreasing the size of endometrioma , with that of luteinizing hormone releasing hormone ( LHRH ) agonist , triptorelin acetate .
METHODS	This was a prospective , randomized study .
METHODS	The setting was in two private medical centers in the UAE , from January 2011 to February 2012 .
METHODS	One hundred and forty patients complaining of endometrioma , and fulfilling the eligibility criteria , were chosen and divided into two groups as follows : Group I comprised 71 patients ; all of them received Cabergoline tablets , 0.5 mg tablets , twice per week for 12weeks .
METHODS	Group II comprised 69 patients ; all of them received LHRH agonist , decapeptyl , 3.75 mg subcutaneous , single injection , once a month for 3months .
METHODS	All patients underwent vaginal ultrasound before and after the treatment period to compare the change in the size of endometrioma by the same sonography team in each hospital that was blind to the treatment groups .
RESULTS	The outcome was measured by the changes in the endometrioma size by vaginal ultrasound after completion of the 3months ' treatment period .
RESULTS	The management line was considered to be significantly effective if the endometrioma size was reduced by more than 25 % of its original pretreatment size .
RESULTS	Group I : 46 out of the 71 patients ( 64.7 % ) had significant decrease in endometrioma size .
RESULTS	Group II : 15 out of 69 patients ( 21.7 % ) had significant decrease in endometrioma size .
RESULTS	Paired t test to compare the means of the two groups was highly significant ( p < 0.05 ) CONCLUSION : Cabergoline ( dostinex ) yields better results in decreasing the size of endometrioma , compared to LHRH-agonist by exerting antiangiogenic effects through vascular endothelial growth factor receptor-2 ( VEGFR-2 ) inactivation .
RESULTS	It has no major side effects , easier to administer , and cheaper than LHRH agonists .

###25519844
BACKGROUND	Among laboratory technicians , the prevalence of neck and shoulder pain is widespread possibly due to typical daily work tasks such as pipetting , preparing vial samples for analysis , and data processing on a computer including mouse work - all tasks that require precision in motor control and may result in extended periods of time spent in static positions.In populations characterized by intense chronic musculoskeletal pain and diagnosed conditions in conjunction with psycho-physiological symptoms such as stress-related pain and soreness and other disabling conditions , multifactorial approaches applying a combination of individually tailored physical and cognitive strategies targeting the areas most needed , may be an effective solution to the physical and mental health challenges.The aim of this study is therefore to investigate the effect of an individually tailored biopsychosocial intervention strategy on musculoskeletal pain , stress and work disability in lab technicians with a history of musculoskeletal pain at a single worksite in Denmark .
METHODS	In this single-blind two-armed parallel-group randomized controlled trial with allocation concealment , participants receive either an individualized multifactorial intervention or `` usual care '' for 10 weeks at the worksite .
METHODS	1 ) female laboratory technician ( 18-67 years of age ) and 2 ) Pain intensity3 ( 0-10 Visual Analogue Scale ) lasting 3 months with a frequency of3 days per week in one or more of the following regions : i ) upper back i ) low back iii ) neck , iv ) shoulder , v ) elbow and/or vi ) hand .
METHODS	1 ) life-threatening disease and 2 ) pregnancy .
METHODS	Stress , as measured by Cohens perceived stress questionnaire is not an inclusion criteria , thus participants can participate regardless of their stress level.We will implement an individualized intervention addressing biopsychosocial elements of musculoskeletal pain with the following components ; i ) increasing physical capacity through strength - and motor control training ; ii ) lowering or preventing development of stress through mindfulness practice and learning de-catastrophizing pain management strategies through cognitive training.The primary outcome at 10-week follow-up is the between-group difference in intensity of perceived musculoskeletal pain during the last week ( average value of back , neck , shoulder , elbow and hand ) assessed by questionnaire ( modified visual analogue scale 0-10 ) .
CONCLUSIONS	This study will provide experimental evidence to guide workplace initiatives designed towards reducing chronic musculoskeletal pain and stress .
BACKGROUND	ClinicalTrials.gov NCT02047669 .

###24445087
OBJECTIVE	Because of the increasing number of interventional endovascular procedures with fluoroscopy and the corresponding high annual dose for interventionalists , additional dose-protecting measures are desirable .
OBJECTIVE	The purpose of this study was to evaluate the effect of disposable radiation-absorbing surgical drapes in reducing scatter radiation exposure for interventionalists and supporting staff during an endovascular aneurysm repair ( EVAR ) procedure .
METHODS	This was a randomized control trial in which 36 EVAR procedures were randomized between execution with and without disposable radiation-absorbing surgical drapes ( Radpad : Worldwide Innovations & Technologies , Inc. , Kansas City , US , type 5511A ) .
METHODS	Dosimetric measurements were performed on the interventionalist ( hand and chest ) and theatre nurse ( chest ) with and without the use of the drapes to obtain the dose reduction and effect on the annual dose caused by the drapes .
RESULTS	Use of disposable radiation-absorbing surgical drapes resulted in dose reductions of 49 % , 55 % , and 48 % , respectively , measured on the hand and chest of the interventionalist and the chest of the theatre nurse .
CONCLUSIONS	The use of disposable radiation-absorbing surgical drapes significantly reduces scatter radiation exposure for both the interventionalist and the supporting staff during EVAR procedures .

###25189430
OBJECTIVE	Clonidine may help prevent cardiac complications in patients undergoing non-cardiac surgery and receiving chronic beta-blocker therapy .
OBJECTIVE	We conducted a multicentre pilot randomized trial to estimate recruitment rates for a full-scale trial and to assess the safety and tolerability of combining clonidine with chronic beta-blockade .
METHODS	Patients who were at elevated perioperative cardiac risk , receiving chronic beta-blockade , and scheduled for major non-cardiac surgery were recruited in a blinded ( participants , clinicians , outcome assessors ) placebo-controlled randomized trial at three Canadian hospitals .
METHODS	Participants were randomized to clonidine ( 0.2 mg oral tablet one hour before surgery , plus 0.2 mgday ( -1 ) transdermal patch placed one hour before surgery and removed four days after surgery or hospital discharge , whichever came first ) or matching placebo .
METHODS	Feasibility was evaluated based on recruitment rates , with each centre being required to recruit 50 participants within 12-18 months .
METHODS	Additionally , we reviewed study drug withdrawals and safety outcomes , including clinically significant hypotension or bradycardia .
RESULTS	Eighty-two of the 168 participants were randomized to receive clonidine and 86 to receive placebo .
RESULTS	The average time to recruit 50 participants at each centre was 14.3 months .
RESULTS	Six patients ( 7 % ) withdrew from clonidine , while four ( 5 % ) withdrew from placebo .
RESULTS	Based on qualitative review , there were no major safety concerns related to clonidine .
RESULTS	There was a moderate overall rate of cardiac morbidity , with 18 participants ( 11 % ) suffering postoperative myocardial infarction .
CONCLUSIONS	This pilot randomized trial confirmed the feasibility , safety , and tolerability of a full-scale trial of oral and transdermal clonidine for reducing the risk of cardiac complications during non-cardiac surgery .
CONCLUSIONS	This trial was registered at www.clinicaltrials.gov : NCT00335582 .

###25509737
OBJECTIVE	To explore the effect and feasibility of acupuncture in uterine involution after cesarean section .
METHODS	Seventy cases of cesarean section in primipara were randomized into an observation group ( 33 cases ) and a control group ( 37 cases ) .
METHODS	In the control group , the conventional treatment was adopted after cesarean section .
METHODS	In the observation group , on the basic treatment as the control group , acupuncture was applied at Sanyinjiao ( SP 6 ) , Hegu ( LI 4 ) , Qihai ( CV 6 ) and Guanyuan ( CV 4 ) .
METHODS	In 2 h after operation , acupuncture started , once a day , continuously for five times .
METHODS	The daily height of uterine fundus , daily uterine fundus decreasing degree , postpartum blood loss , lochia duration and ultrasonic B test in 42 days of postpartum were compared between the two groups .
RESULTS	The therapeutic methods of the two groups all promoted uterine contraction .
RESULTS	The postpartum height of uterine fundus in the observation group was lower than that in the control group ( all P < 0.05 ) and the uterine fundus decreasing degree was higher than that in the control group ( all P < 0.05 ) .
RESULTS	The blood loss in 2 h , 6 to 12 h and 24 to 48 h of postpartum was less than that in the control group ( all P < 0.05 ) .
RESULTS	The lochia duration in the observation group was shorter than that in the control group ( P < 0.05 ) .
CONCLUSIONS	Acupuncture promotes uterine contraction , reduces postpartum blood loss and lochia duration and benefits uterine involution after cesarean section .

###24461613
BACKGROUND	We compared the efficacy and safety of indacaterol and tiotropium in patients with severe chronic obstructive pulmonary disease ( COPD ) and a history of at least one moderate to severe exacerbation in the previous 12 months .
METHODS	In this multicentre , randomised , blinded , double-dummy , parallel group study , we enrolled patients aged 40 years or older with severe COPD and at least one exacerbation within the previous year .
METHODS	We used a computer-generated sequence to randomly allocate patients ( 1:1 ; stratified by baseline inhaled corticosteroid use , with the balance of treatments maintained at country level ) to receive either indacaterol ( 150 g ) or tiotropium ( 18 g ) once-daily for 52 weeks .
METHODS	Our primary and key secondary objectives were to investigate whether indacaterol was non-inferior to tiotropium for trough forced expiratory volume in 1 s ( FEV1 ) at week 12 ( primary endpoint ) , and for rate of exacerbations at week 52 ( secondary endpoint ) .
METHODS	Analysis populations for the primary and key secondary endpoints were per-protocol sets .
METHODS	The safety set included all patients who received at least one dose of study drug .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00845728 .
RESULTS	Between March 16 , 2009 , and July 5 , 2012 , we enrolled and randomly allocated 3444 patients : 1723 to indacaterol and 1721 to tiotropium .
RESULTS	At week 12 , the estimated least squares mean trough FEV1 difference between the groups was -0.011 L ( least squares mean with indacaterol [ n = 1450 ] 1.134 L [ SE 0.008 ] vs tiotropium [ n = 1467 ] 1.145 L [ 0.008 ] ; one-sided 97.5 % CI lower limit -0.026 L ; p < 0.0001 ) .
RESULTS	The lower limit of the 97.5 % CI was above the prespecified non-inferiority margin of -0.055 L , suggesting that indacaterol was non-inferior to tiotropium .
RESULTS	Indacaterol did not show non-inferiority in terms of annualised exacerbation rates : 0.79 ( indacaterol , n = 1529 ) versus 0.61 ( tiotropium , n = 1543 ) ; ratio 1.29 ( one-sided 97.5 % CI upper limit 1.44 ) .
RESULTS	In the safety set , we recorded no between-group difference in the number of patients who had adverse events ( indacaterol 1119 [ 65 % ] of 1721 patients vs tiotropium 1065 [ 62 % ] of 1718 patients ) or serious adverse events ( indacaterol , 263 [ 15 % ] of 1721 patients vs tiotropium , 255 [ 15 % ] of 1718 patients ) .
RESULTS	Respiratory disorders , particularly worsening of COPD , were the most common adverse events ( COPD : indacaterol , 747 [ 43 % ] of 1721 patients and tiotropium , 665 [ 39 % ] of 1718 patients ) and serious adverse events ( COPD : indacaterol , 147 [ 9 % ] of 1721 patients and tiotropium , 121 [ 7 % ] of 1718 patients ) .
CONCLUSIONS	Indacaterol and tiotropium provided clinically relevant improvements in lung function with comparable safety profiles .
CONCLUSIONS	Tiotropium afforded greater protection from exacerbations , although the absolute number of events was small and the difference between treatments is of uncertain clinical importance .
CONCLUSIONS	The present data offer evidence consistent with current guidelines .
BACKGROUND	Novartis Pharma AG .

###25298575
OBJECTIVE	To estimate and compare the cost-effectiveness and safety of nebivolol with sustained-release metoprolol in reducing blood pressure by 1 mm of Hg per day in hypertensive patients .
METHODS	This was a prospective , randomized , open label , observational analysis of cost-effectiveness , in a questionnaire-based fashion to compare the cost of nebivolol ( 2.5 mg , 5 mg , 10 mg ) and sustained released metoprolol succinate ( 25 mg , 50 mg , 100 mg ) in hypertensive patients using either of the two drugs .
METHODS	A total of 60 newly detected drug nave hypertensive patients were considered for the comparison , of which 30 patients were prescribed nebivolol and the other 30 were prescribed metoprolol succinate as per the recommended dosage .
METHODS	Based on the data , statistical analysis was carried out using GraphPad Prism 5 and MS Excel Spreadsheet 2007 .
RESULTS	The cost of reducing 1 mm of Hg blood pressure per day with nebivolol was 0.60 , 0.70 , and 1.06 INR , whereas that of metoprolol succinate was 0.93 , 1.18 , and 1.25 INR at their respective equivalent doses , hence significantly lower with the nebivolol group as compared to the metoprolol group ( P < 0.05 ) .
CONCLUSIONS	This pharmacoeconomic analysis shows that nebivolol is more cost-effective as compared to metoprolol when the cost per reduction in blood pressure per day is considered .
CONCLUSIONS	This may affect the patients economically during their long-term use of these molecules for the treatment of hypertension .

###24423928
BACKGROUND	Female breast cancer patients with a BRCA1/2 mutation have an increased risk of contralateral breast cancer .
BACKGROUND	We investigated the effect of rapid genetic counselling and testing ( RGCT ) on choice of surgery .
METHODS	Newly diagnosed breast cancer patients with at least a 10 % risk of a BRCA1/2 mutation were randomised to an intervention group ( offer of RGCT ) or a control group ( usual care ; ratio 2:1 ) .
METHODS	Primary study outcomes were uptake of direct bilateral mastectomy ( BLM ) and delayed contralateral prophylactic mastectomy ( CPM ) .
RESULTS	Between 2008 and 2010 , we recruited 265 women .
RESULTS	On the basis of intention-to-treat analyses , no significant group differences were observed in percentage of patients opting for a direct BLM ( 14.6 % for the RGCT group vs 9.2 % for the control group ; odds ratio ( OR ) 2.31 ; confidence interval ( CI ) 0.92-5 .81 ; P = 0.08 ) or for a delayed CPM ( 4.5 % for the RGCT group vs 5.7 % for the control group ; OR 0.89 ; CI 0.27-2 .90 ; P = 0.84 ) .
RESULTS	Per-protocol analysis indicated that patients who received DNA test results before surgery ( 59 out of 178 women in the RGCT group ) opted for direct BLM significantly more often than patients who received usual care ( 22 % vs 9.2 % ; OR 3.09 , CI 1.15-8 .31 , P = 0.03 ) .
CONCLUSIONS	Although the large majority of patients in the intervention group underwent rapid genetic counselling , only a minority received DNA test results before surgery .
CONCLUSIONS	This may explain why offering RGCT yielded only marginally significant differences in uptake of BLM .
CONCLUSIONS	As patients who received DNA test results before surgery were more likely to undergo BLM , we hypothesise that when DNA test results are made routinely available pre-surgery , they will have a more significant role in surgical treatment decisions .

###25556022
OBJECTIVE	To assess links between comorbid health status , severe excess weight , and weight-related quality of life ( WRQOL ) in adolescents with severe obesity and undergoing weight-loss surgery ( WLS ) to inform clinical care .
METHODS	Baseline ( preoperative ) data from Teen Longitudinal Assessment of Bariatric Surgery , a prospective multicenter observational study of 242 adolescents with severe obesity ( MedianBMI = 50.5 kg/m ( 2 ) ; Meanage = 17.1 ; 75.6 % female ; 71.9 % white ) undergoing WLS , were used to examine the impact of demographics , body mass index ( BMI ) , presence/absence of 16 comorbid conditions , and a cumulative comorbidity load ( CLoad ) index on WRQOL scores ( Impact of Weight on Quality of Life-Kids ) .
RESULTS	WRQOL was significantly lower than reference samples of healthy weight , overweight , and obese samples .
RESULTS	Of 16 comorbid conditions , the most prevalent were dyslipidemia ( 74.4 % ) , chronic pain ( 58.3 % ) , and obstructive sleep apnea ( 56.6 % ) .
RESULTS	Male subjects had a greater CLoad ( P = .01 ) and BMI ( P = .01 ) , yet less impairment in total WRQOL ( P < .01 ) than females .
RESULTS	CLoad was a significant predictor of male WRQOL .
RESULTS	For females , psychosocial ( vs physical ) comorbidities , BMI , and white race were significant predictors of WRQOL impairment .
RESULTS	Less prevalent conditions ( eg , stress urinary incontinence ) also emerged as contributors to lower WRQOL .
CONCLUSIONS	WRQOL impairment is substantial for adolescents with severe obesity undergoing WLS , with predictors varying by sex .
CONCLUSIONS	These patient-data highlight targets for education , support , and adjunctive care referrals before WLS .
CONCLUSIONS	Furthermore , they provide a comprehensive empirical base for understanding heterogeneity in adolescent WRQOL outcomes after WLS , as weight and comorbidity profiles change over time .

###24298766
OBJECTIVE	To evaluate the effects and safety of penetrating needling on head acupoints for perennial allergic rhinitis ( PAR ) .
METHODS	Eighty-one cases of PAR were randomly divided into an acupuncture group ( 41 cases ) and a medication group ( 40 cases ) .
METHODS	Penetrating needling at head acupoints was adopted from Baihui ( GV 20 ) to Qianding ( GV 21 ) and from Shangxing ( GV 23 ) to Shenting ( GV 24 ) in the acupuncture group .
METHODS	A to tal 4-week treatment was given to the patients with 3 treatments a week .
METHODS	Loratadine tablet and azelastine hydrochloride nasal spray were given to the medication group continuously for 12 days .
METHODS	A follow-up was carried out 3 months after the treatment .
METHODS	The efficacy , symptom score and physical sign score , and side accidents were observed in both groups .
RESULTS	The total effective rate was 95.1 % ( 39/41 ) in the acupuncture group , which was better than 82.5 % ( 33/40 ) in the medication group ( P < 0.05 ) .
RESULTS	The total scores of clinical symptoms and each partial scores after the treatment , and total scores of clinical symptoms in follow-up were obviously decreased in both groups ( all P < 0.01 ) , the nasal obstruction score and the total scores of clinical symptoms in the acupuncture group were better than those in the medication group ( P < 0.01 , P < 0.05 ) .
RESULTS	Obvious side-effect had not been found during the treatment .
CONCLUSIONS	Penetrating needling at head acupoints is a safe therapy for patients with PAR , and favorable effects can be found in both short term and long term .

###24701663
OBJECTIVE	Skin fragments during lumbar punctures may develop intraspinal epidermoid tumors .
OBJECTIVE	The aim of this study was to determine the incidence of epithelial cells that reflow along with the fi rst and third drops of CSF of patients undergoing spinal anesthesia .
METHODS	Samples of the fi rst and third drops of cerebrospinal fluid were collected from 39 adult patients undergoing spinal anesthesia with a 25G Quincke needle .
METHODS	Four microscope slides were prepared : one for the fi rst drop , one for third drop , one for the needle , and one with a drop of saline for control .
METHODS	A pathologist examined the slides randomly .
RESULTS	Squamous epithelial cells were identified in 35 ( 89.7 % ) samples from the fi rst drop , 34 ( 87.2 % ) from the third drop , and 24 ( 61.5 % ) from spinal needle .
RESULTS	The third drop showed a mean number of cells larger than the fi rst drop ( p = 0.046 ) .
RESULTS	Nucleated epithelial cells were found in a sample of the fi rst drop ( 2.56 % ) , in four samples of third drop ( 10.25 % ) , and in one spinal needle ( 2.56 % ) .
RESULTS	Third drop showed a mean number of nucleated cells higher than fi rst drop with no statistical difference ( p = 0.257 ) .
CONCLUSIONS	High percentage of epithelial cells was found in the fi rst ( 89.7 % ) and third ( 87.2 % ) drops of CSF reflow and in used needles ( 61.5 % ) .
CONCLUSIONS	Skin cells were found even using small gauge disposable needles with well-adapted mandrel .

###24281905
BACKGROUND	Omega-3 fatty acids ( n-3 FAs ) may have beneficial clinical effects , and n-3 FA supplements may improve outcome after surgery .
METHODS	In a randomized double-blind placebo-controlled trial in single centre , patients referred for elective colorectal cancer surgery received either an n-3 FA-enriched oral nutritional supplement ( ONS ) ( Supportan , 200 ml twice daily ) providing 2.0 g eicosapentaenoic acid ( EPA ) and 1.0 g docosahexaenoic acid ( DHA ) per day , or a standard isocaloric and isonitrogenous ONS , for 7 days before and 7 days after surgery .
METHODS	The primary endpoint was infectious and non-infectious complications within 30 days of surgery .
METHODS	Secondary endpoints were length of hospital stay , intensive care unit admission , readmissions , and concentrations of marine n-3 FAs and arachidonic acid in granulocyte membranes .
RESULTS	Some 148 consecutive patients ( 68 women , 80 men ; mean age 71 ( range 41-89 ) years ) were randomized .
RESULTS	There was no significant difference between groups in infectious or non-infectious postoperative complications ( P = 1.000 ) .
RESULTS	Granulocyte levels of EPA , DHA and docosapentaenoic acid ( DPA ) were significantly higher in the n-3 FA-enriched supplement group compared with the control group ( P < 0.001 ) .
RESULTS	The arachidonic acid level in granulocytes was significantly lower in the enriched group than in the control group ( P < 0.001 ) .
CONCLUSIONS	EPA , DHA and DPA were incorporated into granulocytes in patients receiving n-3 FAs , but this was not associated with improved postoperative outcomes .
BACKGROUND	NCT00488904 ( http://www.clinicaltrials.gov ) .

###25367691
BACKGROUND	The aim of this study was to investigate and evaluate the efficacy of Rheum emodi in the management of primary dysmenorrhoea .
METHODS	A randomized , single-blind , standard controlled trial compared efficacy of R. emodi against mefenamic acid on diagnosed subjects of primary dysmenorrhoea for three consecutive cycles .
METHODS	Experimental group ( n = 30 ) received capsules of R. emodi powder two times a day , two days before the expected date of menstruation , and continued first three days of menstruation , while control group ( n = 15 ) participants received mefenamic acid capsules three times a day on the same protocol .
METHODS	The primary outcome measures were reduced in severity and duration of pain , assessed by visual analogue scale ( VAS ) and verbal multidimensional scoring system ( VMSS ) , and secondary outcome measures were overall improvement of dysmenorrhoea and improved in quality of life ( QOL ) .
METHODS	Statistical analysis was done by repeated measures analysis of variance and Chi-square/Fisher Exact test .
RESULTS	The menstrual pain was significantly decreased in both groups after three-cycle intervention .
RESULTS	Significant changes were observed in VAS ( p < 0.001 ) and VMSS ( p < 0.001 ) in the experimental group .
RESULTS	There is a significant ( p < 0.001 ) reduction in duration of pain in both the groups .
RESULTS	Associated symptoms and QOL were markedly improved after treatment ( p < 0.001 ) .
CONCLUSIONS	It has been clear from the above result that R. emodi is an effective herb in alleviating symptoms of primary dysmenorrhoea .
CONCLUSIONS	It can serve as an alternative treatment without any apparent side effects .
CONCLUSIONS	These results deserve further investigations .

###24608204
OBJECTIVE	To compare the efficacy and complication rates of two different techniques for inferior alveolar nerve blocks ( IANB ) .
METHODS	A randomized , triple-blind clinical trial comprising 109 patients who required lower third molar removal was performed .
METHODS	In the control group , all patients received an IANB using the conventional Halsted technique , whereas in the experimental group , a modified technique using a more inferior injection point was performed .
RESULTS	A total of 100 patients were randomized .
RESULTS	The modified technique group showed a significantly higher onset time in the lower lip and chin area , and was frequently associated to a lingual electric discharge sensation .
RESULTS	Three failures were recorded , 2 of them in the experimental group .
RESULTS	No relevant local or systemic complications were registered .
CONCLUSIONS	Both IANB techniques used in this trial are suitable for lower third molar removal .
CONCLUSIONS	However , performing an inferior alveolar nerve block in a more inferior position ( modified technique ) extends the onset time , does not seem to reduce the risk of intravascular injections and might increase the risk of lingual nerve injuries .

###25222305
BACKGROUND	In a randomized trial comparing nevirapine ( NVP ) - based versus lopinavir/ritonavir ( LPV/r ) - based antiretroviral therapy ( ART ) in HIV-infected children [ primary endpoint discontinuation of study treatment for any reason or virologic failure by week 24 ] aged 2 months to 3 years , we assessed whether clinical , virologic , immunologic and safety outcomes varied by prior single-dose NVP exposure ( PrNVP ) for prevention of mother-to-child HIV transmission and other covariates .
METHODS	Efficacy was assessed by time to ART discontinuation or virologic failure , virologic failure/death and death ; safety by time to ART discontinuation because of a protocol-defined toxicity and first grade 3 adverse event ; immunology and growth by changes in CD4 % , weight/height World Health Organization z-scores from entry to week 48 .
METHODS	Cox proportional hazards and linear regression models were used to test whether treatment differences depended on PrNVP exposure and other covariates .
RESULTS	Over a median follow up of 48 ( PrNVP ) and 72 ( no PrNVP ) weeks , there was no evidence of differential treatment effects by PrNVP exposure or any other covariates .
RESULTS	LPV/r-based ART was superior to NVP-based ART for efficacy and safety outcomes ; however , those on NVP had larger improvements in CD4 % , weight and height z-scores .
RESULTS	Lower pretreatment CD4 % and higher HIV-1 RNA levels were associated with reduced efficacy , lower pretreatment CD4 % with shorter time to ART discontinuation because of a protocol-defined toxicity , and no PrNVP with shorter time to first grade 3 adverse event .
CONCLUSIONS	Differences between LPV/r and NVP ART in efficacy , safety , immunologic and growth outcomes did not depend on PrNVP exposure , prior breast-feeding , sex , HIV-1 subtype , age , pretreatment CD4 % , HIV-1 RNA or World Health Organization disease stage .
CONCLUSIONS	This finding should be considered when selecting an ART regimen for young children .

###25529832
OBJECTIVE	To describe characteristics associated with neurotoxicity ( NT ) in advanced ovarian cancer patients treated on Gynecologic Oncology Group 218 and examine effect of substituting docetaxel for paclitaxel in these patients .
METHODS	The development of NT was defined as Common Toxicity Criteria grade ( G ) 1 .
METHODS	The association between substitution with docetaxel and NT improvement was explored with generalized estimating equations adjusting for treatment cycle and NT grading at previous cycle .
RESULTS	Of 1864 evaluable patients , 1329 ( 71 % ) developed G1 NT during the study .
RESULTS	Nearly half appeared within the first two cycles of chemotherapy , with 31 % experiencing G2 .
RESULTS	Older patients or those with worse quality of life ( QoL ) scores at baseline ( p < 0.05 ) were more likely to experience NT .
RESULTS	One-hundred-six patients received docetaxel as substitute for paclitaxel .
RESULTS	Of them , 47 patients started with docetaxel at cycle one due to reaction to paclitaxel ( n = 32 ) , fear of NT ( n = 4 ) , and other reasons ( n = 11 ) , whereas 59 patients switched to docetaxel during cycle 2-6 due to NT ( n = 32 ) , reaction to paclitaxel ( n = 19 ) , and other reasons ( n = 8 ) .
RESULTS	Although the protocol instructed otherwise , the majority continued paclitaxel despite G2 NT symptoms .
RESULTS	There was no evidence that substitution with docetaxel improved NT ( Odds Ratio : 1.57 ; 95 % CI 0.98-2 .54 ; p > 0.05 ) .
RESULTS	Of 59 patients who switched to docetaxel , only seven ( 12 % ) discontinued taxane prior to chemotherapy completion .
RESULTS	A roughly equal chance of worsening NT was reported on paclitaxel ( 6 % ) as on docetaxel ( 5 % ) .
CONCLUSIONS	Age and worse QoL at baseline are associated with NT .
CONCLUSIONS	Substitution of docetaxel did not improve NT symptoms .

###24504441
BACKGROUND	In a randomized phase III study , trametinib prolonged progression-free survival and improved overall survival versus chemotherapy in patients with BRAF V600 mutation-positive melanoma .
METHODS	Patients ' quality of life ( QOL ) was assessed at baseline and follow-up visits using the European Organisation for Research and Treatment of Cancer Core QOL questionnaire .
RESULTS	In the primary efficacy population ( BRAF V600E + , no brain metastases ) from baseline to weeks 6 and 12 , patients ' global health status scores worsened by 4-5 points with chemotherapy but improved by 2-3 points with trametinib .
RESULTS	Rapid and substantive reductions in QOL functionality ( e.g. role functioning , 8-11 points at weeks 6 and 12 ) and symptom exacerbation ( e.g. fatigue , 4-8 points ; nausea and vomiting , 5 points , both at weeks 6 and 12 ) were observed in chemotherapy-treated patients .
RESULTS	In contrast , trametinib-treated patients reported small improvements or slight worsening from baseline at week 12 , depending on the functional dimension and symptom .
RESULTS	The mean symptom-scale scores for chemotherapy-treated patients increased from baseline ( symptoms worsened ) for seven of eight symptoms at week 6 ( except insomnia ) and six of eight symptoms at week 12 ( except dyspnea and insomnia ) .
RESULTS	In contrast , at weeks 6 and 12 , the mean symptom-scale scores for trametinib decreased from baseline ( symptoms improved ) for pain ( 11-12 points ) , insomnia ( 10-12 points ) , and appetite loss ( 1-5 points ) , whereas those for diarrhea worsened ( 15-16 points ) .
RESULTS	Mixed-model repeated-measures analyses showed significant ( P < 0.05 ) and/or clinically meaningful improvements ( small to moderate ) from baseline in favor of trametinib for global health ; physical , role , and social functioning ; fatigue ; pain ; insomnia ; nausea and vomiting ; constipation ; dyspnea ; and appetite at weeks 6 and/or 12 .
RESULTS	QOL results for the intent-to-treat population were consistent .
CONCLUSIONS	This first QOL assessment for a MEK inhibitor in metastatic melanoma demonstrated that trametinib was associated with less functional impairment , smaller declines in health status , and less exacerbation of symptoms versus chemotherapy .

###24779680
BACKGROUND	Daily azithromycin decreases acute exacerbations of chronic obstructive pulmonary disease ( AECOPD ) , but long-term side effects are unknown .
OBJECTIVE	To identify the types of exacerbations most likely to be reduced and clinical subgroups most likely to benefit from azithromycin , 250 mg daily , added to usual care .
METHODS	Enrollment criteria included irreversible airflow limitation and AECOPD requiring corticosteroids , emergency department visit , or hospitalization in the prior year or use of supplemental oxygen .
METHODS	Recurrent events and cumulative incidence analyses compared treatment received for AECOPD by randomization group , stratified by subgroups of interest .
METHODS	Cox proportional hazards models estimated treatment effects in subgroups adjusted for age , sex , smoking status , FEV1 % predicted , concomitant COPD medications , and oxygen use .
RESULTS	Azithromycin was most effective in reducing AECOPD requiring both antibiotic and steroid treatment ( n = 1,113 ; cumulative incidence analysis , P = 0.0002 ; recurrent events analysis , P = 0.002 ) .
RESULTS	No difference in treatment response by sex ( P = 0.75 ) , presence of chronic bronchitis ( P = 0.19 ) , concomitant inhaled therapy ( P = 0.29 ) , or supplemental oxygen use ( P = 0.23 ) was observed .
RESULTS	Older age and milder Global Initiative for Chronic Obstructive Lung Disease stage were associated with better treatment response ( P = 0.02 and 0.04 , respectively ) .
RESULTS	A significant interaction between treatment and current smoking was seen ( P = 0.03 ) and azithromycin did not reduce exacerbations in current smokers ( hazard ratio , 0.99 ; 95 % confidence interval , 0.71-1 .38 ; P = 0.95 ) .
CONCLUSIONS	Azithromycin is most effective in preventing AECOPD requiring both antibiotic and steroid treatment .
CONCLUSIONS	Adjusting for confounders , we saw no difference in efficacy by sex , history of chronic bronchitis , oxygen use , or concomitant COPD therapy .
CONCLUSIONS	Greater efficacy was seen in older patients and milder Global Initiative for Chronic Obstructive Lung Disease stages .
CONCLUSIONS	We found little evidence of treatment effect among current smokers .
CONCLUSIONS	Clinical trial registered with www.clinicaltrials.gov ( NCT0011986 and NCT00325897 ) .

###24517156
BACKGROUND	Current osteoporosis medications increase bone mineral density ( BMD ) modestly and reduce , but do not eliminate , fracture risk .
BACKGROUND	Attempts to improve efficacy by administering anabolic agents and bisphosphonates concomitantly have been unsuccessful .
BACKGROUND	Conversely , 12 months of concomitant denosumab and teriparatide therapy increases BMD more than either drug alone .
OBJECTIVE	The purpose of this study was to determine whether 24 months of combined denosumab and teriparatide will increase hip and spine BMD more than either individual agent .
METHODS	Preplanned continuation of the Denosumab and Teriparatide Administration ( DATA ) randomized controlled trial in which postmenopausal osteoporotic women received teriparatide ( 20 g daily ) , denosumab ( 60 mg every 6 months ) , or both medications for 24 months .
METHODS	Participants were 94 postmenopausal women with osteoporosis .
METHODS	Lumbar spine , femoral neck , total hip , and distal radius BMD and serum markers of bone turnover were measured .
RESULTS	At 24 months , lumbar spine BMD increased more in the combination group ( 12.9 5.0 % ) than in either the teriparatide ( 9.5 5.9 % , P = .01 ) or denosumab ( 8.3 3.4 % , P = .008 ) groups .
RESULTS	Femoral neck BMD also increased more in the combination group ( 6.8 3.6 % ) than in either the teriparatide ( 2.8 3.9 % , P = .003 ) or denosumab ( 4.1 3.8 % , P = .008 ) groups .
RESULTS	Similarly , total hip BMD increased more in the combination group ( 6.3 2.6 % ) than in the teriparatide ( 2.0 3.0 % ) or denosumab ( 3.2 2.5 % ) groups ( P < .001 for both ) .
RESULTS	Although spine and hip BMD continued to increase in the second year in all groups , these year 2 increases did not differ among groups .
RESULTS	Serum C-telopeptide and N-terminal propeptide of type 1 procollagen were equally suppressed in the denosumab and combination groups , whereas osteocalcin decreased more in the denosumab group than in the combination group , a difference that persisted , but lessened , in the second year of therapy .
CONCLUSIONS	Two years of concomitant teriparatide and denosumab therapy increases BMD more than therapy with either medication alone and more than has been reported with any current therapy .
CONCLUSIONS	The combination of these agents may prove to be an important treatment option in patients at high risk of fracture .

###25746151
BACKGROUND	Biocompatible solutions may lower peritonitis rates , but are more costly than conventional solutions .
BACKGROUND	The aim of the present study was to assess the additional costs and health outcomes of biocompatible over conventional solutions in incident peritoneal dialysis patients to guide practice decisions .
METHODS	Secondary economic evaluation of a randomized controlled trial .
METHODS	185 participants in the balANZ trial .
METHODS	Cost-effectiveness of biocompatible compared to standard solution over the 2 years using an Australian health care funder perspective .
METHODS	Intervention group received biocompatible solutions and control group received standard solutions over 2 years .
RESULTS	Costs included dialysis charges , costs of treating peritonitis , non-peritonitis-related hospital stays , and medication .
RESULTS	Peritonitis was the health outcome of interest ; incremental cost-effectiveness ratios were reported in terms of the additional cost per additional patient avoiding peritonitis at 2 years .
RESULTS	Mean total per-patient costs were A$ 57,451 and A$ 53,930 for the biocompatible and standard-solution groups , respectively .
RESULTS	The base-case analysis indicated an incremental cost of A$ 17,804 per additional patient avoiding peritonitis at 2 years for biocompatible compared to standard solution .
RESULTS	In a sensitivity analysis excluding extreme outliers for non-peritonitis-related hospitalizations , mean per-patient costs were A$ 49,159 and A$ 52,009 for the biocompatible and standard-solution groups , respectively .
RESULTS	Consequently , the incremental cost-effectiveness ratio also was reduced significantly : biocompatible solution became both less costly and more effective than standard solution and , in economic terms , was dominant over standard solution .
CONCLUSIONS	Peritonitis was a secondary outcome of the balANZ trial .
CONCLUSIONS	Health outcomes measured only in terms of patients avoiding peritonitis over 2 years may underestimate the longer term benefits ( eg , prolonged technique survival ) .
CONCLUSIONS	Biocompatible dialysis solutions may offer a cost-effective alternative to standard solutions for peritoneal dialysis patients .
CONCLUSIONS	Reductions in peritonitis-related hospital costs may offset the higher costs of biocompatible solution .

###24274215
BACKGROUND	Nasal polyposis ( NP ) is defined as a specific form of chronic rhinosinusitis ( CRS ) , characterized by bilateral and multifocal polyps .
BACKGROUND	Functional endoscopic sinus surgery represents the gold standard therapy when medical treatment fails .
BACKGROUND	The availability of different tools raises the question of which one provides significant advances in technique and surgical outcome .
BACKGROUND	This study considered the outcome of the surgical treatment of NP in relation to several comorbidities and the surgical device used : the microdebrider versus the Blakesley traditional forceps .
BACKGROUND	Other studies compared the two instruments but did not evaluate the clinical relevance of history of comorbidities such as asthma , allergy , and eosinophilia .
METHODS	A prospective randomized single-blind study was designed to analyze 311 cases of bilateral CRS with NP .
METHODS	Each patient served as his/her own control , meaning that one side was operated on using the Blakesley forceps and the opposite side using the microdebrider .
METHODS	The follow-up period was 13.3 1.2 months .
RESULTS	The Blakesley forceps caused a significantly lower NP recurrence rate than the microdebrider ( p < 0.001 ) , which was more effective in preventing synechia formation ( p < 0.05 ) .
RESULTS	Only asthma was significantly associated with a higher recurrence rate , without being influenced by the instrument used ( p < 0.001 ) .
CONCLUSIONS	The manual instrument allowed for a significantly lower recurrence incidence but yielded a higher rate of synechia formation compared with the microdebrider .
CONCLUSIONS	Only asthma was significantly associated with a poorer clinical outcome , and gender , age , allergy , and eosinophilia did not affect the surgical prognosis .

###24524385
OBJECTIVE	We assessed the effectiveness of a worksite management intervention ( the 3W program ) for overweight and obese hotel employees .
METHODS	The program was tested in a 2-year cluster-randomized trial involving 30 hotels that employed nearly 12,000 individuals .
METHODS	All participating hotels were on Oahu , Hawaii .
METHODS	The intervention was implemented within hotel worksites .
METHODS	Participants were included in the analysis if they had an initial body mass index ( BMI ) 25 , were assessed at least twice , were not missing other data needed for the analysis , and did not switch to employment at a hotel in a different experimental condition .
METHODS	Of the 6519 employees we assessed , data from 1207 individuals ( intervention : 598 ; control : 610 ) met these criteria and contributed to the analysis .
METHODS	The intervention had two components : ( 1 ) group meetings and ( 2 ) a workplace environment intervention .
METHODS	Weight and waist to height ratio ( WHtR ) were measured at three annual assessments .
METHODS	The effect of the intervention on change in BMI and WHtR was estimated in hierarchical mixed regression models using full maximum likelihood to estimate model parameters .
RESULTS	The effects on change in BMI and WHtR were in the expected direction but were not statistically significant .
CONCLUSIONS	The 3W program was not effective .
CONCLUSIONS	The low intensity of the intervention may have contributed to its ineffectiveness .

###24480604
OBJECTIVE	To determine whether kangaroo holding of healthy preterm infants over the first eight weeks of an infant 's life facilitates co-regulation of salivary cortisol between mother and infant .
METHODS	Randomized control trial .
METHODS	Infants were assigned to receive 1h of daily kangaroo ( skin-to-skin contact on the chest of mother ) or blanket holding ( dressed and held in mother 's arms ) .
METHODS	A registered nurse visited mothers weekly for eight weeks to encourage holding and provide information about infant development .
METHODS	A control group had no holding restrictions and received weekly brief social visits .
METHODS	The study included 79 preterm infants , born between 32 and 35weeks gestational age and were a mean of 15days ( 5.7 ) at enrollment .
METHODS	Co-regulation was conceptualized as progressive reduction in the absolute difference between mother and infant cortisol levels across 60min of holding at each holding session .
METHODS	Mother and infant cortisol levels were measured before holding and at 30 and 60min after holding began during three holding sessions ( baseline and at two and eight weeks after study initiation ) .
METHODS	Primary analyses were conducted using hierarchical linear models .
RESULTS	There was much variability in cortisol levels .
RESULTS	Levels of mother and infant cortisol decreased during holding .
RESULTS	No significant co-regulation occurred in any group at any holding session or over time .
CONCLUSIONS	Decreasing level of cortisol in both mothers and infants suggests that holding promoted the expected decline in stress hormone levels .
CONCLUSIONS	However , supported holding methods did not differentially affect co-regulation compared to controls .
CONCLUSIONS	Holding is pleasurable and stress may need to be present in order for mothers and infants to demonstrate co-regulation in cortisol levels .

###24359174
BACKGROUND	The drug treatments of choice for obsessive-compulsive disorder ( OCD ) are serotonin reuptake inhibitors ( SRIs ) .
BACKGROUND	However , a correlation between the neuropeptide oxytocin in cerebrospinal fluid and the severity of OCD has previously been shown , and oxytocin and serotonin are interconnected within the brain .
BACKGROUND	Few studies have investigated whether SRIs have any effect on oxytocin ; thus , our aim was to explore the possibility that oxytocinergic mechanisms contribute to the anti-obsessive effect of SRIs .
METHODS	In a randomized , double-blind trial , comparing SRIs ( clomipramine and paroxetine ) with placebo in 36 adults with OCD ( characterized for subtypes ) , plasma oxytocin was measured with radioimmunoassay after plasma extraction , at baseline , after 1 week , and after 4 weeks of treatment , and related to baseline severity and clinical response after 12 weeks , as measured by the Yale-Brown Obsessive Compulsive Scale ( Y-BOCS ) .
RESULTS	Baseline oxytocin levels correlated positively with baseline Y-BOCS ratings , but only among the future SRI responders .
RESULTS	Patients with early onset of OCD had higher baseline oxytocin .
RESULTS	During treatment , plasma oxytocin did not differ between SRI and placebo treatment .
RESULTS	In SRI responders , plasma oxytocin first decreased and then increased ; in non-responders ( to SRI as well as to placebo ) , the reverse was the case .
RESULTS	After 4 weeks , treatment responders had attained higher oxytocin levels compared to non-responders .
RESULTS	The intra-individual range ( i.e. , the variability ) of plasma oxytocin between measurements was the measure that best differentiated responders from non-responders .
RESULTS	This range was higher in responders than non-responders , and lower in patients with autistic traits .
CONCLUSIONS	SRIs have highly variable effects on plasma oxytocin between individuals .
CONCLUSIONS	The associations between baseline oxytocin and OCD severity and between oxytocin changes and treatment response support the notions that oxytocin is involved in OCD pathophysiology , and that the anti-obsessive effects of SRIs are partly exerted through oxytocinergic mechanisms .

###25487877
OBJECTIVE	To investigate the intra-ocular pressure ( IOP ) - lowering effects of a selective Rho kinase inhibitor , ripasudil ( K-115 ) , over 24 hr in patients with primary open-angle glaucoma ( POAG ) or ocular hypertension ( OHT ) .
METHODS	In this multicenter , prospective , randomized , open-label , 3-period , Latin-square crossover clinical study , 28 patients with POAG or OHT whose IOP level was 21 mmHg or higher were subdivided into three groups .
METHODS	Each patient was treated with placebo and ripasudil in concentrations of 0.2 and 0.4 % , at 9:00 and 21:00 on day 1 through a total of 3 periods separated by washout periods .
METHODS	IOP was measured at 9:00 , 10:00 , 11:00 , 13:00 , 16:00 , 19:00 , 21:00 , 22:00 and 23:00 on day 1 , and 1:00 , 4:00 , 7:00 and 9:00 on day 2 in sitting position using Goldmann applanation tonometer .
METHODS	Main outcome measure was the IOP reduction of placebo and ripasudil from baseline .
RESULTS	The mean IOP reduction was -5.2 mmHg for 0.2 % , -6.4 mmHg for 0.4 % and -2.0 mmHg for placebo at 2 hr after the first instillation .
RESULTS	Also , the corresponding values were -6.8 mmHg for 0.2 % , -7.3 mmHg for 0.4 % and -4.1 mmHg for placebo at 2 hr after the second instillation .
RESULTS	Statistically significant IOP reduction , compared with placebo , was found for both 0.2 and 0.4 % from 1 through 7 hr after each instillation .
RESULTS	In safety , conjunctival hyperaemia was observed in 22 patients ( 79 % ) for 0.2 % , 27 patients ( 96 % ) for 0.4 % and three patients ( 11 % ) for placebo .
CONCLUSIONS	Ripasudil is a promising new topical medication to lower IOP for at least 7 hr after instillations in patients with POAG or OHT .

###24576799
BACKGROUND	Extremely preterm babies ( delivered at < 28 completed weeks of gestation ) are frequently diagnosed with hypotension and treated with inotropic and pressor drugs in the immediate postnatal period .
BACKGROUND	Dopamine is the most commonly used first-line drug .
BACKGROUND	Babies who are treated for hypotension more frequently sustain brain injury , have long-term disability or die compared to those who are not .
BACKGROUND	Despite the widespread use of drugs to treat hypotension in such infants , evidence for efficacy is lacking , and the effect of these agents on long-term outcomes is unknown .
OBJECTIVE	In extremely preterm babies , restricting the use of dopamine when mean blood pressure ( BP ) values fall below a nominal threshold and using clinical criteria to determine escalation of support ( ` restricted ' approach ) will result in improved neonatal and longer-term developmental outcomes .
OBJECTIVE	RESEARCH PLAN : In an international multi-centre randomised trial , 830 infants born at < 28 weeks of gestation , and within 72 h of birth , will be allocated to 1 of 2 alternative treatment options ( dopamine vs. restricted approach ) to determine the better strategy for the management of BP , using a conventional threshold to commence treatment .
OBJECTIVE	The first co-primary outcome of survival without brain injury will be determined at 36 weeks ' postmenstrual age and the second co-primary outcome ( survival without neurodevelopmental disability ) will be assessed at 2 years of age , corrected for prematurity .
CONCLUSIONS	It is essential that appropriately designed trials be performed to define the most appropriate management strategies for managing low BP in extremely preterm babies .

###25369488
OBJECTIVE	Cytotoxic T-lymphocyte-associated antigen 4 ( CTLA-4 ) blockade with ipilimumab prolongs survival in patients with metastatic melanoma .
OBJECTIVE	CTLA-4 blockade and granulocyte-macrophage colony-stimulating factor ( GM-CSF ) - secreting tumor vaccine combinations demonstrate therapeutic synergy in preclinical models .
OBJECTIVE	A key unanswered question is whether systemic GM-CSF ( sargramostim ) enhances CTLA-4 blockade .
OBJECTIVE	To compare the effect of ipilimumab plus sargramostim vs ipilimumab alone on overall survival ( OS ) in patients with metastatic melanoma .
METHODS	The Eastern Cooperative Oncology Group ( ECOG ) conducted a US-based phase 2 randomized clinical trial from December 28 , 2010 , until July 28 , 2011 , of patients ( N = 245 ) with unresectable stage III or IV melanoma , at least 1 prior therapy , no central nervous system metastases , and ECOG performance status of 0 or 1 .
METHODS	Patients were randomized to receive ipilimumab , 10 mg/kg , intravenously on day 1 plus sargramostim , 250 g subcutaneously , on days 1 to 14 of a 21-day cycle ( n = 123 ) vs ipilimumab alone ( n = 122 ) .
METHODS	Ipilimumab treatment included induction for 4 cycles followed by maintenance every fourth cycle .
METHODS	Primary end point : comparison of length of OS .
METHODS	Secondary end point : progression-free survival ( PFS ) , response rate , safety , and tolerability .
RESULTS	Median follow-up was 13.3 months ( range , 0.03-19 .9 ) .
RESULTS	Median OS as of December 2012 for ipilimumab plus sargramostim was 17.5 months ( 95 % CI , 14.9-not reached ) vs 12.7 months ( 95 % CI , 10.0-not reached ) for ipilimumab .
RESULTS	The 1-year survival rate for ipilimumab plus sargramostim was 68.9 % ( 95 % CI , 60.6 % -85.5 % ) compared to 52.9 % ( 95 % CI , 43.6 % -62.2 % ) for ipilimumab alone ( stratified log-rank 1-sided P = .01 ; mortality hazard ratio 0.64 [ 1-sided 90 % repeated CI , not applicable-0 .90 ] ) .
RESULTS	A planned interim analysis was conducted at 69.8 % of expected events ( 104 observed with 149 expected deaths ) .
RESULTS	Planned interim analysis using the O'Brien-Fleming boundary was crossed for improvement in OS .
RESULTS	There was no difference in PFS .
RESULTS	Median PFS for ipilimumab plus sargramostim was 3.1 months ( 95 % CI , 2.9-4 .6 ) vs 3.1 months ( 95 % CI , 2.9-4 .0 ) for ipilimumab alone .
RESULTS	Grade 3 to 5 adverse events occurred in 44.9 % ( 95 % CI ; 35.8 % -54.4 % ) of patients in the ipilimumab plus sargramostim group vs 58.3 % ( 95 % CI , 49.0 % -67.2 % ) of patients in the ipilimumab-alone group ( 2-sided P = .04 ) .
CONCLUSIONS	Among patients with unresectable stage III or IV melanoma , treatment with ipilimumab plus sargramostim vs ipilimumab alone resulted in longer OS and lower toxicity , but no difference in PFS .
CONCLUSIONS	These findings require confirmation in larger studies with longer follow-up .
BACKGROUND	clinicaltrials.gov Identifier : NCT01134614 .

###24911576
OBJECTIVE	This paper aimed to evaluate the effects of coadministered immediate-release morphine and ethanol on safety , pharmacokinetic , and pharmacodynamic measures .
METHODS	In the first stage of a randomized , double-blind , placebo-controlled , crossover study , 16 healthy men with a history of moderate drinking received morphine 50 mg + ethanol 0.7 g/kg , morphine 50 mg + ethanol placebo , and morphine placebo + ethanol 0.7 g/kg .
METHODS	In the second stage , participants received either a lower ( 30 mg ) or higher ( 80 mg ) morphine dose ( alone and in combination with ethanol ) depending on their tolerability to treatments in stage 1 .
METHODS	Safety , pharmacodynamic ( including visual analog scales , pupillometry , capnography , and psychomotor and cognitive measures ) , and pharmacokinetic assessments were conducted .
RESULTS	With the exception of one severe adverse event ( AE ) , all others were mild or moderate in intensity .
RESULTS	Morphine resulted in dose-related increases in AEs .
RESULTS	When morphine was administered with ethanol , similar AEs were observed ( dizziness , headache , somnolence , nausea , and vomiting ) , but these were sometimes more frequent compared with those observed with either drug alone .
RESULTS	No consistent additive or interaction effects were observed on pharmacodynamic measures .
RESULTS	Ethanol had no apparent effects on the pharmacokinetics of morphine or its metabolites .
CONCLUSIONS	Coadministration of single doses of morphine and ethanol tested in this study did not affect the safety , pharmacodynamics , or pharmacokinetics of morphine or ethanol administered alone .
CONCLUSIONS	Copyright 2014 John Wiley & Sons , Ltd. .

###24902407
OBJECTIVE	To assess the plaque removal efficacy of an oscillating-rotating power brush relative to a newly-introduced sonic power brush .
METHODS	This study used a randomized , examiner-blind , single-center , two-treatment , parallel group 4-week design .
METHODS	Subjects with pre-existing plaque scores of at least 1.75 on the Turesky Modification of the Quigley-Hein Plaque Index ( TMQHPI ) were evaluated for baseline whole mouth and approximal plaque scores .
METHODS	They received either the oscillating-rotating brush ( Oral-B Professional Care 1000 , sold as Oral-B Professional Care 600 in some regions , with the Oral-B Precision Clean brush head , D16u/EB20 ) or the sonic brush ( Colgate ProClinical C200 with Colgate Triple Clean brush head ) and brushed twice-daily with the assigned brush and a standard fluoride dentifrice for 4 weeks before returning for plaque measurements .
METHODS	Prior to baseline and the Week 4 measurements , participants abstained from oral hygiene for 12 hours and from eating , chewing gum and drinking for 4 hours .
RESULTS	A total of 131 subjects were enrolled in the study at baseline , with all completing the study : 65 in the oscillating-rotating group , and 66 in the sonic group .
RESULTS	Both brushes significantly reduced plaque over the 4-week study period .
RESULTS	The oscillating-rotating brush was statistically significantly more effective in reducing plaque ( P < 0.001 ) than the sonic brush .
RESULTS	Compared to the sonic power brush , the adjusted mean plaque reduction scores for the oscillating-rotating power brush were more than five times greater for whole mouth and approximal areas .

###25802966
OBJECTIVE	The objective of this study was to evaluate possible mechanisms for functional improvement and compare ambulation training with surface peroneal nerve stimulation vs. usual care via quantitative gait analysis .
METHODS	This study is a randomized controlled clinical trial .
METHODS	The setting of this study is a teaching hospital of an academic medical center .
METHODS	One hundred ten chronic stroke survivors ( > 12 wks poststroke ) with unilateral hemiparesis participated in this study .
METHODS	The subjects were randomized to a surface peroneal nerve stimulation device or usual care intervention .
METHODS	The subjects were treated for 12 wks and followed up for 6-mo posttreatment .
METHODS	Spatiotemporal , kinematic , and kinetic parameters of gait were the main outcome measures .
RESULTS	Cadence ( F3 ,153 = 5.81 , P = 0.012 ) , stride length ( F3 ,179 = 20.01 , P < 0.001 ) , walking speed ( F3 ,167 = 18.2 , P < 0.001 ) , anterior-posterior ground reaction force ( F3 ,164 = 6.61 , P = 0.004 ) , peak hip power in preswing ( F3 ,156 = 8.76 , P < 0.001 ) , and peak ankle power at push-off ( F3 ,149 = 6.38 , P = 0.005 ) all improved with respect to time .
RESULTS	However , peak ankle ankle dorsiflexion in swing ( F3 ,184 = 4.99 , P = 0.031 ) worsened .
RESULTS	In general , the greatest change for all parameters occurred during the treatment period .
RESULTS	There were no significant treatment group time interaction effects for any of the spatiotemporal , kinematic , or kinetic parameters .
CONCLUSIONS	Gait training with peroneal nerve stimulation and usual care was associated with improvements in peak hip power in preswing and peak ankle power at push-off , which may have resulted in improved cadence , stride length , and walking speed ; however , there were no differences between treatment groups .
CONCLUSIONS	Both treatment groups also experienced a decrease in peak ankle ankle dorsiflexion in swing , although the clinical implications of this finding are unclear .

###25114907
OBJECTIVE	To investigate the effectiveness of four-channel FES based on a normal gait pattern on improving functional ability in subjects early after ischemic stroke .
METHODS	Forty-five subjects were randomly assigned into a four-channel FES group ( n = 16 ) , a placebo group ( n = 15 ) , or a dual-channel group ( n = 14 ) .
METHODS	Stimulation lasted for 30min in each session with 1 session/day , 5 days a week for 3 weeks .
METHODS	All subjects were assessed at baseline , at 3 weeks of treatment , and at 3 months after the treatment had finished .
METHODS	The assessments included Fugl-Meyer Assessment ( FMA ) , the Postural Assessment Scale for Stroke Patients ( PASS ) , Berg Balance Scale ( BBS ) , Functional Ambulation Category ( FAC ) , and the Modified Barthel Index ( MBI ) .
RESULTS	All 3 groups demonstrated significant improvements in all outcome measurements from pre - to posttreatment and further gains at followup .
RESULTS	The score of FMA and MBI improved significantly in the four-channel group at the end of the 3 weeks of training .
RESULTS	And the scores of PASS , BBS , MBI , and FAC in the four-channel group were significantly higher than those of the placebo group .
CONCLUSIONS	This study indicated that four-channel FES can improve motor function , balance , walking ability , and performance of activities of daily living in subjects with early ischemic stroke .

###25541338
BACKGROUND	Topical application of tranexamic acid to the knee joint before closure in total knee arthroplasty reduces postoperative bleeding without increase in complication .
BACKGROUND	However , it is unknown the effectiveness of topic TXA performed with other topical medications , like povidone-iodine solution .
METHODS	One hundred and twenty-five patients were randomized to receive 100mL of povidone-iodine solution ( control : group A ) or 1.5 ( group B ) and 3.0 g ( group C ) of topical TXA in povidone-iodine solution applied into the knee before closure in total knee arthroplasty .
RESULTS	The patients in the TXA groups had higher mean postoperative hemoglobin levels ( P = 0.01 and P = 0.03 in groups B and C , respectively ) and a reduced postoperative blood loss in the TXA groups ( P = 0.07 and P = 0.09 in groups B and C , respectively ) .
RESULTS	No significant complications were observed .
CONCLUSIONS	In this study , topical application of tranexamic acid after total knee arthroplasty together with povidone-iodine solution results in higher postoperative hemoglobin levels and lower blood loss compared with those in the control group without other complications .
METHODS	I - I : high-powered prospective randomized trial .

###24251378
BACKGROUND	Identifying pretreatment dietary habits that are associated with weight-loss intervention outcomes could help guide individuals ' selection of weight-loss approach among competing options .
BACKGROUND	A pretreatment factor that may influence weight-loss outcomes is macronutrient intake .
METHODS	Overweight and obese Durham Veterans Affairs outpatients were randomised to a weight-loss intervention with a low-carbohydrate diet ( n = 71 ) or orlistat medication therapy plus a low-fat diet ( n = 73 ) .
METHODS	Percentage fat , carbohydrate and protein intake prior to treatment were measured using 4-day food records .
METHODS	Linear mixed-effects models were used to determine whether pretreatment percentage macronutrient intake influenced weight trajectories and weight loss in each weight-loss condition .
RESULTS	Participant 's mean age was 53 years , baseline body mass index was 39.3 kg m ( -2 ) and 72 % were male .
RESULTS	A higher pretreatment percentage carbohydrate intake was associated with less rapid initial weight loss ( P = 0.02 ) and less rapid weight regain ( P = 0.03 ) in the low-carbohydrate diet condition but was not associated with weight trajectories in the orlistat plus low-fat diet condition .
RESULTS	In both conditions , a higher pretreatment percentage fat intake was associated with more rapid weight regain ( P < 0.01 ) .
RESULTS	Pretreatment percentage protein intake was not associated with weight trajectories .
RESULTS	None of the pretreatment macronutrients were associated with weight loss on study completion in either condition .
CONCLUSIONS	Selection of a weight-loss approach on the basis of pretreatment macronutrient intake is unlikely to improve weight outcomes at the end of a 1-year treatment .
CONCLUSIONS	However , pretreatment macronutrient intake may have implications for tailoring of interventions to slow weight regain after weight loss .

###25017670
BACKGROUND	Chronic severe tinnitus can be greatly detrimental to quality of life .
BACKGROUND	Some authors have reported benefit of repetitive transcranial magnetic stimulation , others of electrical cortical stimulation by stimulating the Heschl 's gyrus or secondary auditory areas .
OBJECTIVE	To evaluate the efficacy of chronic electrical epidural stimulation of the auditory cortex on severe and disabling tinnitus .
METHODS	In this double-blind randomized cross-over , patients with chronic ( at least 2 years ) , severe ( Strukturierte Tinnitus-Interview , STI score > 19 ) , unilateral or strongly lateralized tinnitus were included .
METHODS	After open-phase stimulation for 4 months , patients were randomized into 2 groups for double-blind stimulation with cross-over between significant and non-significant phases and wash-out in between .
METHODS	Each of the 3 phases was 2 weeks in duration .
METHODS	Patients were chronically stimulated and followed if not explanted .
METHODS	A decrease of STI score > 35 % was considered as clinically significant .
RESULTS	None of the 9 patients included achieved significant improvement during the double-blind phase .
RESULTS	Four were explanted , 2 owing to lack of effect , one for breast cancer under the stimulator , and another for psychiatric decompensation .
RESULTS	Five are still stimulated .
RESULTS	Three felt slight to great subjective effectiveness , the remaining 2 reported benefits and still requested stimulation .
CONCLUSIONS	This study did not find an objective efficiency of chronic cortical stimulation for severe and resistant tinnitus .
CONCLUSIONS	The discordance between the results in double-blind and open evaluations could be related to a placebo effect of surgery , but may also be explained by a poorly defined target , a too short randomized phase , or inappropriate outcome measures .
CONCLUSIONS	Clinical trial reference : NCT00486577 .

###24727262
OBJECTIVE	To evaluate critically visual field ( VF ) improvement in participants in the Collaborative Initial Glaucoma Treatment Study ( CIGTS ) .
METHODS	Prospective , comparative case series from a randomized clinical trial comparing trabeculectomy and topical medications in treating open-angle glaucoma ( OAG ) .
METHODS	A total of 607 subjects with newly diagnosed OAG were identified for study .
METHODS	Baseline and follow-up VF tests were obtained and mean deviation ( MD ) change from baseline over follow-up was analyzed .
METHODS	Clinically substantial change ( loss or improvement ) was defined as change from baseline of 3 decibels in MD. .
METHODS	Baseline factors were inspected to determine their association with VF improvement in repeated measures regression models .
RESULTS	The percentage of participants showing substantial VF improvement over time was similar to that showing VF loss through 5 years after initial treatment , after which VF loss became more frequent .
RESULTS	Measures of better intraocular pressure ( IOP ) control during treatment were significantly predictive of VF improvement , including a lower mean IOP , a lower minimum IOP , and lower sustained levels of IOP over follow-up .
RESULTS	Other predictive factors included female sex ( odds ratio [ OR ] = 1.73 ) , visits 1 year prior to cataract extraction ( OR = 0.11 ) , and an interaction between treatment and baseline MD wherein surgically treated subjects with worse baseline VF loss were more likely to show VF improvement .
CONCLUSIONS	In the CIGTS , substantial VF loss and improvement were comparable through 5 years of follow-up , after which VF loss became more frequent .
CONCLUSIONS	Predictive factors for VF improvement included several indicators of better IOP control , which supports the postulate that VF improvement was real .

###25632091
OBJECTIVE	To examine the effect of cost , a traditionally `` inactive '' trait of intervention , as contributor to the response to therapeutic interventions .
METHODS	We conducted a prospective double-blind study in 12 patients with moderate to severe Parkinson disease and motor fluctuations ( mean age 62.4 7.9 years ; mean disease duration 11 6 years ) who were randomized to a `` cheap '' or `` expensive '' subcutaneous `` novel injectable dopamine agonist '' placebo ( normal saline ) .
METHODS	Patients were crossed over to the alternate arm approximately 4 hours later .
METHODS	Blinded motor assessments in the `` practically defined off '' state , before and after each intervention , included the Unified Parkinson 's Disease Rating Scale motor subscale , the Purdue Pegboard Test , and a tapping task .
METHODS	Measurements of brain activity were performed using a feedback-based visual-motor associative learning functional MRI task .
METHODS	Order effect was examined using stratified analysis .
RESULTS	Although both placebos improved motor function , benefit was greater when patients were randomized first to expensive placebo , with a magnitude halfway between that of cheap placebo and levodopa .
RESULTS	Brain activation was greater upon first-given cheap but not upon first-given expensive placebo or by levodopa .
RESULTS	Regardless of order of administration , only cheap placebo increased activation in the left lateral sensorimotor cortex and other regions .
CONCLUSIONS	Expensive placebo significantly improved motor function and decreased brain activation in a direction and magnitude comparable to , albeit less than , levodopa .
CONCLUSIONS	Perceptions of cost are capable of altering the placebo response in clinical studies .
METHODS	This study provides Class III evidence that perception of cost is capable of influencing motor function and brain activation in Parkinson disease .

###24859111
OBJECTIVE	To compare two strategies for colorectal cancer screening : one-time colonoscopy versus fecal immunochemical testing ( FIT ) ( and colonoscopy for positive ) every 2 years , in order to determine which strategy provides the highest participation and detection rates in groups of sex and age .
METHODS	This analysis was performed with data from the first screening round within the COLONPREV study , a population-based , multicenter , nationwide trial carried out in Spain .
METHODS	Several logistic regression models were applied to identify the influence of the screening test on participation rates and detection of proximal and distal neoplasms , as well to identify the influence of age and sex : women aged 50-59 years , women aged 60-69 years , men aged 50-59 years , and men aged 60-69 years .
RESULTS	Participation was higher in women than in men , especially among women aged 50-59 years ( 25.91 % for colonoscopy and 35.81 % for FIT ) .
RESULTS	Crossover from colonoscopy to FIT was higher among women than men , especially among those aged 60-69 years ( 30.37 % ) .
RESULTS	In general , detection of any neoplasm and advanced adenoma was higher with colonoscopy than with FIT , but no significant differences were found between the two strategies for colorectal cancer detection .
RESULTS	Detection of advanced adenoma in both arms was lower in women [ specifically in women aged 50-59 years ( OR 0.31 ; 95 % CI 0.25-0 .38 ) than in men aged 60-69 years ] .
RESULTS	Women aged 50-59 years in the colonoscopy arm had a higher probability of detection of advanced adenoma ( OR 4.49 ; 95 % CI 3.18-6 .35 ) , as well as of detection of neoplasms in proximal and distal locations ( proximal OR 19.34 ; 95 % CI 12.07-31 .00 ; distal OR 11.04 ; 95 % CI 8.13-15 .01 ) than women of the same age in the FIT arm .
RESULTS	These differences were also observed in the remaining groups but to a lesser extent .
CONCLUSIONS	Women were more likely to participate in a FIT-based strategy , especially those aged 50-59 years .
CONCLUSIONS	The likelihood of detection of any neoplasm was higher in the colonoscopy arm for all the population groups studied , especially in women aged 50-59 years .
CONCLUSIONS	Distinct population groups should be informed of the benefits of each screening strategy so that they may take informed decisions .

###24859868
BACKGROUND	The inverse association between physical activity and cancer risk may be mediated by higher melatonin levels .
BACKGROUND	However , few studies have examined the effect of increased physical activity on melatonin levels .
METHODS	The parent study was a randomized controlled trial that randomized 51 men and 49 women to a 12-month moderate-to-vigorous aerobic exercise intervention ( `` exercisers '' ) and 51 men and 51 women to a stretching control ( `` controls '' ) .
METHODS	Participants were of ages 40 to 75 years , and previously sedentary .
METHODS	Levels of the principal urinary metabolite of melatonin , 6-sulfatoxymelatonin ( aMT6s ) , corrected for creatinine levels , were measured in spot morning urine samples by immunoassay at baseline and 12 months .
METHODS	Changes in levels between exercisers and controls were compared using generalized estimating equations for linear regression .
RESULTS	We observed no statistically significant difference in the change in aMT6s levels from baseline to 12 months in exercisers compared with controls ( change in aMT6s levels : exercisers , +6.5 % ; controls , +13 % ; P = 0.66 ) .
RESULTS	There was no evidence of effect modification by age , sex , or body mass index .
CONCLUSIONS	A 12-month moderate-intensity exercise intervention did not affect levels of aMT6s .
CONCLUSIONS	Further research needs to focus on other potential mechanisms through which physical activity may reduce the risk of cancer .
CONCLUSIONS	Cancer Epidemiol Biomarkers Prev ; 23 ( 8 ) ; 1696-9 .2014 AACR .

###24827934
BACKGROUND	Studies from European-American cultures consistently reported that expressive suppression was associated with worse emotional consequence ( e.g. depression ) in comparison with acceptance .
BACKGROUND	However , this conclusion may not apply to Chinese , as suppressing emotional displays to maintain relational harmony is culturally valued in East Asian countries .
BACKGROUND	Thus , the present study examined the effects of suppression and acceptance on the depressive mood induced by a frustrating task in a Chinese sample .
METHODS	Sixty-four subjects were randomly assigned to one of three instructions : suppression , acceptance or no-regulation during a frustrating arithmetic task .
METHODS	The experience of depressive emotion and skin conductance response ( SCR ) were recorded during pre-frustration baseline , frustration induction and post-frustration recovery phases , respectively .
RESULTS	Compared with the control and acceptance instructions , suppression instruction was associated with decreased depressive experiences and smaller SCR activity during frustration .
RESULTS	There were no significant differences between acceptance and control groups in both subjective depression and SCR activity during frustration .
RESULTS	Moreover , the suppression group showed a better emotional recovery after the frustrating task , in comparison with the acceptance and control groups .
RESULTS	Correlation analyses verified that SCR reactivity was a reliable index of experienced depression during the frustration .
CONCLUSIONS	Expressive suppression is effective in reducing depressive experiences and depression-related physiological activity ( SCR ) when Chinese people are involved .
CONCLUSIONS	By contrast , the acceptance of depressive emotion in Chinese people does not produce a similar regulation effect .
CONCLUSIONS	These findings suggest that cultural context should be considered in understanding the emotional consequences of suppression and acceptance strategies .

###25500425
OBJECTIVE	We evaluated the efficacy and safety of obeticholic acid ( OCA , - ethylchenodeoxycholic acid ) in a randomized controlled trial of patients with primary biliary cirrhosis who had an inadequate response to ursodeoxycholic acid therapy .
METHODS	We performed a double-blind study of 165 patients with primary biliary cirrhosis ( 95 % women ) and levels of alkaline phosphatase ( ALP ) 1.5 - to 10-fold the upper limit of normal .
METHODS	Patients were randomly assigned to groups given 10 mg , 25 mg , or 50 mg doses of OCA or placebo , once daily for 3 months .
METHODS	Patients maintained their existing dose of ursodeoxycholic acid throughout the study .
METHODS	The primary outcome was change in level of ALP from baseline ( day 0 ) until the end of the study ( day 85 or early termination ) .
METHODS	We also performed an open-label extension of the trial in which 78 patients were enrolled and 61 completed the first year .
RESULTS	OCA was superior to placebo in achieving the primary end point .
RESULTS	Subjects given OCA had statistically significant relative reductions in mean ALP from baseline to the end of the study ( P < .0001 all OCA groups vs placebo ) .
RESULTS	Levels of ALP decreased 21 % -25 % on average from baseline in the OCA groups and 3 % in the placebo group .
RESULTS	Sixty-nine percent ( 68 of 99 ) of patients given OCA had at least a 20 % reduction in ALP compared with 8 % ( 3 of 37 ) of patients given placebo ( P < .0003 ) .
RESULTS	Among secondary end points , levels of - glutamyl transpeptidase decreased 48 % -63 % , on average , among subjects given OCA , vs a 7 % decrease in the group given placebo ; levels of alanine aminotransferase decreased 21 % -35 % on average among subjects given OCA vs none of the patients given placebo .
RESULTS	Pruritus was the principal adverse event ; incidence values in the OCA 10 mg , 25 mg , and 50 mg groups were 47 % ( not significantly different ) , 87 % ( P < .0003 ) , and 80 % ( P < .006 ) , respectively , vs 50 % in the placebo group .
RESULTS	In the extension study , levels of ALP continued to decrease to a mean level of 202 11 U/L after 12 months vs 285 15 U/L at baseline .
CONCLUSIONS	Daily doses of OCA , ranging from 10 to 50 mg , significantly reduced levels of ALP , - glutamyl transpeptidase , and alanine aminotransferase , compared with placebo , in patients with primary biliary cirrhosis who had inadequate responses to ursodeoxycholic acid .
CONCLUSIONS	The incidence and severity of pruritus were lowest among patients who received 10 mg/d OCA .
CONCLUSIONS	Biochemical responses to OCA were maintained in a 12-month open-label extension trial .
CONCLUSIONS	ClinicalTrials.gov ID : NCT00550862 .

###25427289
BACKGROUND	Functional endoscopic sinus surgery ( FESS ) is the mainstay of surgical treatment for sinonasal disease .
BACKGROUND	This surgery carries certain risks .
BACKGROUND	Most of these risks relate to the quality of the surgical field .
BACKGROUND	Thus , mechanisms by which the surgical field can be improved are important to study .
BACKGROUND	We sought to determine whether positive end-expiratory pressure ( PEEP ) had a deleterious effect on the quality of the surgical field in patients undergoing primary FESS .
METHODS	Forty-seven patients were randomized to a ventilation strategy using either 5 cm H2O of PEEP or zero added PEEP .
METHODS	The quality of the surgical field was measured every 15 minutes using a validated surgical scoring method .
RESULTS	The addition of PEEP did not have any measurable effect on the surgical field scores after onset of surgery ( odds ratio [ OR ] ( 95 % confidence interval [ CI ] ) = 1.06 ( 0.44-2 .58 ) , P = 0.895 for side 1 ; OR ( 95 % CI ) = 0.56 ( 0.16-1 .93 ) , P = 0.356 for side 2 ) .
RESULTS	The peak inspiratory pressure did have an effect on surgical grades .
RESULTS	Every cm H2O of added pressure over 15 cm H2O total pressure contributing to increased odds of higher surgical field score .
RESULTS	For each cm H2O increase in inspiratory pressure above 15cm H2O increased the surgical field score ( OR [ 95 % CI ] 1.13 [ 1.04-1 .22 ] , P = 0.002 ) .
CONCLUSIONS	During FESS surgery if PEEP is added , it is important to keep the mean inspiratory pressure below 15cm H2O to avoid worsening surgical field conditions .

###25886635
BACKGROUND	In Japan , a traditional herbal medicine , Tokishigyakukagoshuyushokyoto ( TJ-38 ) , is often used for the treatment of peripheral coldness , which is a common complaint among Japanese women .
BACKGROUND	However , the effects of this herbal medicine have yet to be examined in a randomized controlled trial .
BACKGROUND	In the current study , the effect of TJ-38 on the peripheral blood flow in women experiencing peripheral coldness was investigated using a parallel-group randomized controlled trial .
METHODS	Fifty-eight women aged 23 to 79 years with peripheral coldness were randomly divided into the intervention or control group .
METHODS	They were examined using cold bathing tests , physical examinations , and questionnaires in January 2010 for the baseline and in March 2010 for the follow-up , and January 2011 and March 2011 , respectively .
RESULTS	At the baseline , there were no differences in clinical characteristics between the two groups .
RESULTS	In the intervention group , peripheral coldness improved after the intervention term ; however , it persisted in the control group .
RESULTS	Mean values of percentage recovery of the peripheral blood flow after cold bathing tests were 17.2 % and -28.2 % for the intervention and control groups , respectively ( p = 0.007 ) , and the proportions for percentage recovery of > 50 % were 32 % and 0 % , respectively ( p = 0.0007 ) .
RESULTS	Mean values of percent recovery of skin temperature did not differ between the two groups .
CONCLUSIONS	The present clinical trial supports that a traditional herbal medicine relieves peripheral coldness in women probably through the improvement of peripheral blood flow .

###24337589
OBJECTIVE	The aim of this study was to compare CKD-810 ( test docetaxel ) with Taxotere ( ) ( reference docetaxel ) in terms of pharmacokinetics and safety for patients with advanced or metastatic carcinoma .
METHODS	A randomized , open-label , two-way crossover study was conducted in eligible patients .
METHODS	Patients received with reference or test drugs of 75 mg/m ( 2 ) docetaxel by intravenous infusion for 60 min in the first period and the alternative drug in the second period with a washout of 3 weeks .
METHODS	Plasma concentrations of docetaxel were determined by validated high-performance liquid chromatography coupled to tandem mass spectrometry detection .
METHODS	Pharmacokinetic parameters , including the maximum plasma concentration ( C ( max ) ) and the area under the concentration-time curve ( AUC ) , were determined by non-compartmental analysis .
RESULTS	A total of 44 patients were included in the study , 21 patients received test drug and 23 received reference drug for the first cycle .
RESULTS	The C ( max ) of docetaxel was 2,658.77 ng/mL for test drug and 2,827.60 ng/mL for reference drug , and two drugs showed no difference with a statistical significance .
RESULTS	Time to reach C ( max ) ( T ( max ) ) of CKD-810 ( 0.94 h ) versus reference docetaxel ( 0.97 h ) was also not significantly different .
RESULTS	Other pharmacokinetic parameters including the plasma AUC , elimination half-life , and total body clearance exhibited similar values without a significant difference .
RESULTS	The most common grade 3 or 4 toxicity was neutropenia ( CKD-810 19.5 or 29.3 % ; reference docetaxel 14.6 or 41.5 % ) .
RESULTS	Febrile neutropenia was experienced by only one patient in each group .
RESULTS	Two patients died of progression of disease during the study .
CONCLUSIONS	Docetaxel anhydrous CKD-810 use with patients suffering advanced or metastatic solid malignancies was equivalent to reference docetaxel in terms of pharmacokinetic parameters and safety profile .
CONCLUSIONS	Additionally , the test and reference drug met the regulatory criteria for pharmacokinetic equivalence .

###24395994
BACKGROUND	Young adulthood is a critical transition period for the development of health behaviors .
BACKGROUND	We present here the results of a randomized controlled trial of an online avatar-hosted personal health makeover program designed for young adult smokers .
METHODS	We conducted a three-group randomized trial comparing delivery of general lifestyle content ( Tx1 ) , personally tailored health information ( Tx2 ) , and personally tailored health information plus online video-based peer coaching ( Tx3 ) as part of a 6-week online health program .
METHODS	Participants were asked to set weekly goals around eating breakfast , exercise , alcohol use , and cigarette smoking .
METHODS	Eligibility criteria included age ( 18-30 years ) and smoking status ( any cigarette use in the previous 30 days ) .
METHODS	The primary outcome was self-reported 30-day abstinence measured 12 weeks postenrollment .
RESULTS	Participant ( n = 1698 ) characteristics were balanced across the groups ( 72 % women , mean age 24 , 26 % nonwhite , 32 % high school education or less , and 50 % daily smokers ) .
RESULTS	Considering intention to treat , 30-day smoking abstinence rates were statistically significantly higher in the intervention groups ( Tx1 = 11 % , Tx2 = 23 % , Tx3 = 31 % , P < .001 ) .
RESULTS	Participants in the intervention groups were also more likely to reduce their number of days spent on binge drinking and increase their number of days eating breakfast and exercising .
RESULTS	Overall , intervention group participants were much more likely to make positive changes in at least three or four of the target behaviors ( Tx1 = 19 % , Tx2 = 39 % , Tx3 = 41 % , P < .001 ) .
CONCLUSIONS	This online avatar-hosted personal health makeover `` show '' increased smoking abstinence and induced positive changes in multiple related health behaviors .
CONCLUSIONS	Addition of the online video-based peer coaching further improved behavioral outcomes .

###25462664
BACKGROUND	Baseline abstinence goal is a robust predictor of cigarette abstinence .
BACKGROUND	However , important questions about goal remain unanswered .
BACKGROUND	These include variables correlating with goal , changes in goal , relationship of goal and abstinence status over time , and predictors of change .
BACKGROUND	The current study aimed to address these questions .
METHODS	Participants were treatment-seeking volunteers in two clinical trials .
METHODS	In Clinical Trial 1 ( N = 402 ) , participants smoked 10 cigarettes per day ( CPD ) and were 50years of age .
METHODS	In Clinical Trial 2 ( N = 406 ) , participants smoked 10 CPD , smoked within 30min of arising , and were 18years of age .
METHODS	The outcome variables were biochemically verified 7-day abstinence from cigarettes at weeks 12 , 24 , 52 , and 104 .
METHODS	Abstinence goal , demographic , psychological , and smoking related variables were assessed via standard instruments .
RESULTS	At baseline , the greater the desire to quit and one 's expectations of success , and the lesser the educational level , the more likely participants were to have a quit forever goal .
RESULTS	Throughout the two-year study , abstinence from cigarettes and a lower educational level were correlated with a goal of quit forever ; 37 % of participants changed goal .
RESULTS	There were no predictors of goal change .
RESULTS	Abstinence goal was related to abstinence status across the study period .
RESULTS	The goal predicted abstinence status at subsequent assessments , even when status was controlled .
CONCLUSIONS	Lesser educational levels were consistent predictors of a more stringent goal .
CONCLUSIONS	Abstinence goal changes over time .
CONCLUSIONS	These findings suggest that repeated counseling about goal is advisable and participants would benefit from such counseling , independent of demographic characteristics and smoking status .

###24973875
BACKGROUND	We investigated the satisfaction of patients and endoscopists and concurrently safety aspects of an `` alfentanil only '' and two clinically routinely used sedation regimes in patients undergoing colonoscopy in a teaching hospital .
METHODS	One hundred and eighty patients were prospectively randomized in three groups : M ( midazolam/fentanyl ) , A ( alfentanil ) , and P ( propofol/alfentanil ) ; M and A were administered by an endoscopy nurse , P by an anesthesia nurse .
METHODS	Interventions , heart rate , saturation , electrocardiogram , noninvasive blood pressure , and expiratory CO were monitored using video assistance .
METHODS	After endoscopy , patients and gastroenterologists completed questionnaires about satisfaction .
RESULTS	A high level of satisfaction was found in all groups , with patients in group P being more satisfied with their sedation experience ( median 1.75 , p < 0.001 ) .
RESULTS	Gastroenterologist satisfaction varied not significantly between the three alternatives .
RESULTS	Patients in group A felt less drowsy , could communicate more rapidly than patients in both other groups , and met discharge criteria immediately after the end of the procedure .
RESULTS	Respiratory events associated with sedation were observed in 43 % patients in group M , 47 % in group P , but only 13 % in group A ( p < 0.001 ) .
CONCLUSIONS	These results suggest that alfentanil could be an alternative for sedation in colonoscopy even in the setting of a teaching hospital .
CONCLUSIONS	It results in satisfied patients easily taking up information , and recovering rapidly .
CONCLUSIONS	Although one might expect to observe more respiratory depression with an `` opioid only '' sedation technique without involvement of anesthesia partners , respiratory events were less frequent than when other methods were used .

###25373836
BACKGROUND	`` Difficult visits '' are common in primary care and may contribute to primary care provider ( PCP ) career dissatisfaction and burnout .
BACKGROUND	Patient requests occur in approximately half of primary care visits and may be a source of clinician-patient miscommunication or conflict , contributing to perceived visit difficulty .
OBJECTIVE	We aimed to determine associations between types of patient requests and PCP-perceived visit difficulty .
METHODS	This was an observational study , nested in a multicenter randomized trial of depression engagement interventions .
METHODS	We included 824 patient visits within 135 PCP practices in Northern California occurring from June 2010 to March 2012 .
METHODS	PCP-perceived visit difficulty was quantified using a three-item scale ( relative visit difficulty , amount of effort required , and amount of time required ; Cronbach 's = 0.81 ) .
METHODS	Using linear regression , the difficulty scale ( score range 0-2 from least to most difficult ) was modeled as a function of : patient requests for diagnostics tests , pain medications , and specialist referrals ; PCP perception of likely depression or likely substance abuse ; patient sociodemographics , comorbidity , depression ; PCP characteristics and practice setting .
RESULTS	Patients requested diagnostic tests , pain medications , and specialist referrals in 37.2 , 20.0 and 30.0 % of visits , respectively .
RESULTS	After adjustment for patient medical and psychiatric complexity , perceived difficulty was significantly higher when patients requested diagnostic tests [ parameter estimate ( PE ) 0.11 , ( 95 % CI : 0.03 , 0.20 ) ] but not when patients requested pain medications [ PE -0.04 ( 95 % CI : -0.15 , 0.08 ) ] or referrals [ PE 0.04 ( 95 % CI : -0.07 , 0.25 ) ] .
CONCLUSIONS	PCP-perceived visit difficulty is associated with patient requests for diagnostic tests , but not requests for pain medications or specialist referrals .
CONCLUSIONS	In this era of `` choosing wisely , '' PCPs may be challenged to respond to diagnostic test requests in an evidence-based manner , while maintaining the provider-patient relationship and PCP career satisfaction .

###24617818
OBJECTIVE	To determine whether the Canine Orthopedic Index ( COI ) can detect changes in dogs with osteoarthritis ( OA ) treated with either non-steroidal anti-inflammatory drugs ( NSAID ) or placebo .
METHODS	Double blind randomized placebo controlled trial .
METHODS	Dogs ( n = 80 ) with OA .
METHODS	Owners completed the COI on Day 0 .
METHODS	Dogs were administered either carprofen or placebo on days 1 through 14 .
METHODS	Owners completed the COI again on Day 14 .
METHODS	The change in total instrument , stiffness , gait , function , and quality of life scores were assessed between groups .
RESULTS	Dogs administered carprofen had significant decreases in the total instrument score ( P = .002 ) as well as 3 of the 4 factor scores compared to dogs treated with placebo ( stiffness score P = .015 ; gait score P = .001 ; and function score = 0.008 ) .
RESULTS	The change in quality of life score was not significantly different between carprofen and placebo treated dogs ( P = .124 ) .
CONCLUSIONS	The COI delivered the decreases in total instrument , stiffness , gait , and function scores that one would expect in dogs with OA treated with an NSAID compared with placebo administration .
CONCLUSIONS	In this cohort of dogs , the quality of life score was not sensitive to the changes associated with NSAID administration .

###24566875
BACKGROUND	Various voice therapy techniques include not only phonation exercises but also measure to regulate tonus of non-larynx related muscles .
BACKGROUND	This is based on the belief that the use of non-laryngeal muscles may affect laryngeal muscle action during phonation onset und phonation .
BACKGROUND	Here we raised the question if indeed a well defined activation of muscles distant to the larynx may effect phonation onset time and the vibratory cycles following thereafter .
METHODS	Prospective partly randomized single center pilot study with 8 healthy volunteers .
METHODS	Analysed variables were time of phonation onset and closed quotient ( Qx ) derived via electroglottgraphy .
METHODS	According to a randomization protocol volunteers had to press a training device ( + condition ) or to keep the hand quiet ( - condition ) .
RESULTS	Comparism of both conditions did not reveal any significant difference , however Qx tended to be higher in the + condition .
CONCLUSIONS	The data presented here does not confirm that activation of hand muscles influences phonation onset time .
CONCLUSIONS	However the preceding vibratory cycles may be altered towards a higher tone of intralaryngeal muscles regulating vocal fold tension .
CONCLUSIONS	Further studies including more volunteers or patients with functional voice disorders and protocols employing the activation of other muscle groups are warranted in order to shed more light into the interrelationship between larynx and other muscle activation during phonation .

###24733000
OBJECTIVE	This study was aimed to evaluate the accuracy of `` True Fast Imaging with Steady-State Precession '' ( TrueFISP ) MR angiography ( MRA ) for diagnosis of renal arterial stenosis ( RAS ) in hypertensive patients .
METHODS	Twenty-two patients underwent both TrueFISP MRA and contrast-enhanced MRA ( CE-MRA ) on a 1.5-T MR imager .
METHODS	Volume of main renal arteries , length of maximal visible renal arteries , number of visualized branches , stenotic grade , and subjective quality were compared .
METHODS	Paired 2-tailed Student t test and Wilcoxon signed rank test were applied to evaluate the significance of these variables .
RESULTS	Volume of main renal arteries , length of maximal visible renal arteries , and number of branches indicated no significant difference between the 2 techniques ( P > 0.05 ) .
RESULTS	Stenotic degree of 10 RAS was greater on CE-MRA than on TrueFISP MRA .
RESULTS	Qualitative scores from TrueFISP MRA were higher than those from CE-MRA ( P < 0.05 ) .
CONCLUSIONS	TrueFISP MRA is a reliable and accurate method for evaluating RAS .

###25236992
OBJECTIVE	The Roland Morris Questionnaire ( RMQ ) is a widely used health status measure for low back pain ( LBP ) .
OBJECTIVE	It is not preference-based , and there are currently no established algorithms for mapping between the RMQ and preference-based health-related quality-of-life measures .
OBJECTIVE	Using data from randomized controlled trials of treatment for LBP , we sought to develop algorithms for mapping between RMQ scores and health utilities derived using either the EuroQol five-dimensional questionnaire ( EQ-5D ) or the six-dimensional health state short form ( derived from Medical Outcomes Study 36-Item Short-Form Health Survey ) ( SF-6D ) .
METHODS	This study is based on data from the Back Skills Training Trial in which data were collected from 701 patients at baseline and subsequently at 3 , 6 , and 12 months postrandomization using a range of outcome measures , including the RMQ , the EQ-5D , and the Short Form 12 item Health Survey ( SF-12 ) ( from which SF-6D utilities can be derived ) .
METHODS	We used baseline trial data to estimate models using both direct and response mapping approaches to predict EQ-5D and SF-6D health utilities and dimension responses .
METHODS	A multistage model selection process was used to assess the predictive accuracy of the models .
METHODS	We then explored different techniques and mapping models that made use of repeated follow-up observations in the data .
METHODS	The estimated mapping algorithms were validated using external data from the UK Back Pain Exercise and Manipulation trial .
RESULTS	A number of models were developed that accurately predict health utilities in this context .
RESULTS	The best performing model for RMQ to EQ-5D mapping was a beta regression with Bayesian quasi-likelihood estimation that included 24 dummy variables for RMQ responses , age , and sex as covariates ( mean squared error 0.0380 ) based on repeated data .
RESULTS	The model selected for RMQ to SF-6D mapping was a finite mixture model that included the overall RMQ score , age , sex , RMQ score squared , age squared , and an interaction term for age and RMQ score as covariates ( mean squared error 0.0114 ) based on repeated data .
CONCLUSIONS	It is possible to reasonably predict EQ-5D and SF-6D health utilities from RMQ scores and responses using regression methods .
CONCLUSIONS	Our regression equations provide an empirical basis for estimating health utilities when EQ-5D or SF-6D data are not available .
CONCLUSIONS	They can be used to inform future economic evaluations of interventions targeting LBP .

###24924278
OBJECTIVE	To investigate the role of preoperative biometry for selecting initial contact lens power .
METHODS	Patients randomized to receive contact lenses in the Infant Aphakia Treatment Study ( IATS ) were retrospectively analyzed .
METHODS	Inclusion criteria were availability of both a preoperative immersion axial length measurement and a 1-month postoperative refractive value .
METHODS	The target contact lens power for distance was determined using 1-month postoperative spherical equivalent refraction ( after adjusting for a vertex distance ) over the known contact lens power .
METHODS	We compared targeted contact lens power for distance with three other treatment techniques : ( 1 ) 30 D contact lens ( 32 D minus 2 D overcorrection for near vision based on IATS protocol ) ; ( 2 ) regression-estimated contact lens power of 84.4 - 3.2 axial length ; and ( 3 ) IOL power calculated using the Sanders-Retzlaff-Kraff ( SRK/T ) regression formula with a modified A-constant ( 112.176 ) .
METHODS	Prediction error ( targeted minus estimated contact lens power ) and its absolute values were calculated .
RESULTS	A total of 34 eyes of 34 patients met inclusion criteria .
RESULTS	Age at the time of cataract surgery was 2.4 1.7 months .
RESULTS	Follow-up refraction was performed at 31 3 days after surgery .
RESULTS	Target contact lens power for distance was 26.0 4.5 D for the IATS cohort ( which excluded infants with corneal diameter < 9 mm ) .
RESULTS	The mean prediction error was -4.0 , -1.0 , and -2.0 D and mean absolute prediction error was 4.4 , 2.2 , and 2.9 D , respectively , for 30 D contact lens , regression , and SRK/T-estimated power .
CONCLUSIONS	Preoperative biometry can be used to estimate contact lens power for distance if an accurate refraction can not be obtained initially .

###25267385
BACKGROUND	Despite the availability of psychosocial evidence-based practices ( EBPs ) , treatment and outcomes for persons with mental disorders remain suboptimal .
BACKGROUND	Replicating Effective Programs ( REP ) , an effective implementation strategy , still resulted in less than half of sites using an EBP .
BACKGROUND	The primary aim of this cluster randomized trial is to determine , among sites not initially responding to REP , the effect of adaptive implementation strategies that begin with an External Facilitator ( EF ) or with an External Facilitator plus an Internal Facilitator ( IF ) on improved EBP use and patient outcomes in 12 months .
METHODS	This study employs a sequential multiple assignment randomized trial ( SMART ) design to build an adaptive implementation strategy .
METHODS	The EBP to be implemented is life goals ( LG ) for patients with mood disorders across 80 community-based outpatient clinics ( N = 1,600 patients ) from different U.S. regions .
METHODS	Sites not initially responding to REP ( defined as < 50 % patients receiving 3 EBP sessions ) will be randomized to receive additional support from an EF or both EF/IF .
METHODS	Additionally , sites randomized to EF and still not responsive will be randomized to continue with EF alone or to receive EF/IF .
METHODS	The EF provides technical expertise in adapting LG in routine practice , whereas the on-site IF has direct reporting relationships to site leadership to support LG use in routine practice .
METHODS	The primary outcome is mental health-related quality of life ; secondary outcomes include receipt of LG sessions , mood symptoms , implementation costs , and organizational change .
CONCLUSIONS	This study design will determine whether an off-site EF alone versus the addition of an on-site IF improves EBP uptake and patient outcomes among sites that do not respond initially to REP. It will also examine the value of delaying the provision of EF/IF for sites that continue to not respond despite EF .
BACKGROUND	ClinicalTrials.gov identifier : NCT02151331 .

###24661479
BACKGROUND	Tonsillectomy causes discomfort in children .
BACKGROUND	Positive therapeutic suggestions ( TS ) may be given to patients while they are emerging from general anesthesia as a potential tool to decrease distress .
OBJECTIVE	This study examined impact of TS on outcomes , when delivered to children emerging from general anesthesia post tonsillectomy .
METHODS	A double blinded randomized controlled trial was conducted with 94 patient/parent pairs .
METHODS	TS and noise recordings were played via headphones post tonsillectomy upon arrival to the Post Anesthesia Care Unit until the child showed signs of waking .
RESULTS	Pain scores at 30 minutes post extubation show significantly lower pain in the TS group , P = .04 ( Mann Whitney U for independent samples ) .
RESULTS	The TS group had 70 % increased likelihood of receiving less intravenous ( IV ) opioid .
CONCLUSIONS	TS may help lower pain in children post tonsillectomy and decrease demand for IV opioid pain management in the 4 - to 8-year-old tonsillectomy population .

###25468459
BACKGROUND	Hemorrhage and liver failure are the two major complications in partial hepatectomy .
BACKGROUND	The finger fracture or clamp crushing technique has been a standard technique used for transection of liver parenchyma .
BACKGROUND	Hepatic vascular Inflow occlusion ( Pringle maneuver , PM ) is often used to minimize blood loss , but hepatic ischemia-reperfusion may result with an increased risk of post-operative liver failure .
BACKGROUND	The Harmonic scalpel ( HS ) has been shown to be effective in reducing blood loss during liver parenchymal transection without any hepatic vascular inflow occlusion .
METHODS	A randomized controlled trial was carried out to evaluate the impact of the two different hepatic transection techniques .
METHODS	The post-operative short-term results were compared .
RESULTS	During the study period , 160 of 212 patients who received partial hepatectomy in our hospital were randomized into 2 groups : the PM group ( n = 80 ) and the HS group ( n = 80 ) .
RESULTS	The numbers of patient who had a poor liver function on post-operative day 5 ( ISLGS Grade B ) were 30 , and 18 , respectively ( p < 0.05 ) .
RESULTS	The post-operative complication rate was significantly higher in the PM group ( 41.3 % versus 22.5 % , p < 0.05 ) .
RESULTS	The HS group had significantly less blood loss and blood transfusion requirements than the PM group ( p < 0.05 ) .
CONCLUSIONS	In conclusion , liver resection carried out using HS without hepatic vascular occlusion was better than using finger fracture or clamp crushing technique with Pringle maneuver .
CONCLUSIONS	The use of HS allowed liver resection to be safely performed , with earlier recovery of liver function , and less surgical complication .

###25437480
OBJECTIVE	To evaluate the rotational stability of a new one-piece hydrophobic acrylic toric intraocular lens ( IOL ) using a custom-developed software for analysis of slit-lamp photographs .
METHODS	In a prospective , multicenter study , 174 eyes were implanted with the TECNIS Toric IOL ( Abbott Medical Optics , Inc. , Santa Ana , CA ) .
METHODS	A custom-developed software was used to analyze high-resolution slit-lamp photographs of 156 eyes taken at day 1 ( baseline ) and 1 , 3 , and 6 months postoperatively .
METHODS	The software uses iris and sclera landmarks to align the baseline image and later images for comparison .
METHODS	Validation of software was performed through repeated analyses of protractor images rotated from 0.1 to 10.0 and randomly selected photographs of 20 eyes .
RESULTS	Software validation showed precision ( repeatability plus reproducibility variation ) of 0.02 using protractor images and 2.22 using slit-lamp photographs .
RESULTS	Good quality slit-lamp images and clear landmarks were necessary for precise measurements .
RESULTS	At 6 months , 94.2 % of eyes had 5 or less change in IOL orientation versus baseline ; only 2 eyes ( 1.4 % ) had axis shift greater than 30 .
RESULTS	Most eyes were within 5 or less of rotation between 1 and 3 months ( 92.9 % ) and 3 and 6 months ( 94.1 % ) .
RESULTS	Mean absolute axis change ( standard deviation ) from 1 day to 6 months was 2.70 5.51 .
CONCLUSIONS	The new custom software was precise and quick in analyzing slit-lamp photographs to determine postoperative toric IOL rotation .

###24910149
OBJECTIVE	The aim was to compare real-time language/cognitive processing in picture naming in adults who stutter ( AWS ) versus typically-fluent adults ( TFA ) .
METHODS	Participants named pictures preceded by masked prime words .
METHODS	Primes and target picture labels were identical or mismatched .
METHODS	Priming effects on naming and picture-elicited ERP activity were analyzed .
METHODS	Vocabulary knowledge correlations with these measures were assessed .
RESULTS	Priming improved naming RTs and accuracy in both groups .
RESULTS	RTs were longer for AWS , and correlated positively with receptive vocabulary in TFA .
RESULTS	Electrophysiologically , posterior-P1 amplitude negatively correlated with expressive vocabulary in TFA versus receptive vocabulary in AWS .
RESULTS	Frontal/temporal-P 1 amplitude correlated positively with expressive vocabulary in AWS .
RESULTS	Identity priming enhanced frontal/posterior-N 2 amplitude in both groups , and attenuated P280 amplitude in AWS .
RESULTS	N400 priming was topographically-restricted in AWS .
CONCLUSIONS	Results suggest that conceptual knowledge was perceptually-grounded in expressive vocabulary in TFA versus receptive vocabulary in AWS .
CONCLUSIONS	Poorer expressive vocabulary in AWS was potentially associated with greater suppression of irrelevant conceptual information .
CONCLUSIONS	Priming enhanced N2-indexed cognitive control and visual attention in both groups .
CONCLUSIONS	P280-indexed focal attention attenuated with priming in AWS only .
CONCLUSIONS	Topographically-restricted N400 priming suggests that lemma/word form connections were weaker in AWS .
CONCLUSIONS	Real-time language/cognitive processing in picture naming operates differently in AWS .

###24372613
OBJECTIVE	l-Theanine ( N-ethyl-l-glutamine ) is an amino acid uniquely found in green tea .
OBJECTIVE	Growing evidence has suggested the possible effects of l-theanine on cognition .
OBJECTIVE	Previously , we found that l-theanine attenuates MK-801-induced deficit in prepulse inhibition ( PPI ) in mice .
OBJECTIVE	In this study , we examined the effect of l-theanine in increasing the PPI in healthy humans .
METHODS	The subjects were 14 healthy adults who underwent PPI testing as a measure of sensorimotor gating 90min after an oral intake of l-theanine ( 0 , 200 , 400 , or 600mg ) .
METHODS	PPI tests were done by examiners who were blind to the dose .
RESULTS	The administration of 200mg of l-theanine and that of 400mg , but not 600mg , significantly increased the % PPI compared to the baseline ( 0mg ) .
RESULTS	There was no significant relation between the dose of l-theanine and the startle magnitude or the habituation of startle response .
RESULTS	The plasma concentrations of l-theanine correlated with the dose of l-theanine .
CONCLUSIONS	The observed effect with 200-400mg of l-theanine on PPI suggested that l-theanine at a particular dose range increases sensorimotor gating in humans .

###25748415
OBJECTIVE	Estimate the efficacy of amoxicillin for acute uncomplicated lower-respiratory-tract infection ( LRTI ) in primary care and demonstrate the use of randomisation-based efficacy estimators .
METHODS	Secondary analysis of a two-arm individually-randomised placebo-controlled trial .
METHODS	Primary care practices in 12 European countries .
METHODS	Patients aged 18 or older consulting with an acute LRTI in whom pneumonia was not suspected by the clinician .
METHODS	Amoxicillin ( two 500mg tablets three times a day for 7days ) or matched placebo .
METHODS	Clinician-rated symptom severity between days 2-4 ; new/worsening symptoms and presence of side effects at 4-weeks .
METHODS	Adherence was captured using self-report and tablet counts .
RESULTS	2061 participants were randomised to the amoxicillin or placebo group .
RESULTS	On average , 88 % of the prescribed amoxicillin was taken .
RESULTS	The original analysis demonstrated small increases in both benefits and harms from amoxicillin .
RESULTS	Minor improvements in the benefits of amoxicillin were observed when an adjustments for adherence were made ( mean difference in symptom severity -0.08 , 95 % CI -0.17 to 0.01 , OR for new/worsening symptoms 0.81 , 95 % CI 0.66 to 0.98 ) as well as minor increases in harms ( OR for side effects 1.32 , 95 % CI 1.12 to 1.57 ) .
CONCLUSIONS	Adherence to amoxicillin was high , and the findings from the original analysis were robust to non-adherence .
CONCLUSIONS	Participants consulting to primary care with an acute uncomplicated LRTI can on average expect minor improvements in outcome from taking amoxicillin .
CONCLUSIONS	However , they are also at an increased risk of experiencing side effects .
BACKGROUND	Eudract-CT 2007-001586-15 and ISRCTN52261229 .
BACKGROUND	The trial was registered at EudraCT in 2007 due to an administrative misunderstanding that EudraCT was a suitable registry -- which it was not in 2007 , but has become since .
BACKGROUND	On discovery of this error , the trial was also registered at ISRCTN ( January 2009 ) .
BACKGROUND	Trial procedures did not change between the two registrations .

###25193424
OBJECTIVE	To determine whether an online support tool can impact anxiety in women experiencing an abnormal mammogram .
METHODS	We developed an online support system using the Comprehensive Health Enhancement Support System ( CHESS ) designed for women experiencing an abnormal mammogram as a model .
METHODS	Our trial randomized 130 of these women to online support ( the intervention group ) or to a list of five commonly used Internet sites ( the comparison group ) .
METHODS	Surveys assessed anxiety and breast cancer worry , and patient satisfaction at three important clinical time points : when women were notified of their abnormal mammogram , at the time of diagnostic imaging , and at the time of biopsy ( if biopsy was recommended ) .
RESULTS	Study participants in the intervention group showed a significant decrease in anxiety at the time of biopsy compared to the comparison group ( p = 0.017 ) .
RESULTS	However , there was no significant difference in anxiety between the intervention group and the comparison group at the time of diagnostic work-up .
RESULTS	We discontinued assessment of patient satisfaction after finding that many women had substantial difficulty answering the questions that referenced their physician , because they did not understand who their physician was for this process of care .
CONCLUSIONS	The combination of the inability to identify the physician providing care during the mammography work-up and anxiety effects seen only after an interaction with the breast imaging team may indicate that online support only decreases the anxiety of women in concert with direct interpersonal support from the healthcare team .

###24559581
BACKGROUND	Patients with advanced cancer have reduced quality of life , which tends to worsen towards the end of life .
BACKGROUND	We assessed the effect of early palliative care in patients with advanced cancer on several aspects of quality of life .
METHODS	The study took place at the Princess Margaret Cancer Centre ( Toronto , ON , Canada ) , between Dec 1 , 2006 , and Feb 28 , 2011.24 medical oncology clinics were cluster randomised ( in a 1:1 ratio , using a computer-generated sequence , stratified by clinic size and tumour site [ four lung , eight gastrointestinal , four genitourinary , six breast , two gynaecological ] ) , to consultation and follow-up ( at least monthly ) by a palliative care team or to standard cancer care .
METHODS	Complete masking of interventions was not possible ; however , patients provided written informed consent to participate in their own study group , without being informed of the existence of another group .
METHODS	Eligible patients had advanced cancer , European Cooperative Oncology Group performance status of 0-2 , and a clinical prognosis of 6-24 months .
METHODS	Quality of life ( Functional Assessment of Chronic Illness Therapy -- Spiritual Well-Being [ FACIT-Sp ] scale and Quality of Life at the End of Life [ QUAL-E ] scale ) , symptom severity ( Edmonton Symptom Assessment System [ ESAS ] ) , satisfaction with care ( FAMCARE-P16 ) , and problems with medical interactions ( Cancer Rehabilitation Evaluation System Medical Interaction Subscale [ CARES-MIS ] ) were measured at baseline and monthly for 4 months .
METHODS	The primary outcome was change score for FACIT-Sp at 3 months .
METHODS	Secondary endpoints included change score for FACIT-Sp at 4 months and change scores for other scales at 3 and 4 months .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01248624 .
RESULTS	461 patients completed baseline measures ( 228 intervention , 233 control ) ; 393 completed at least one follow-up assessment .
RESULTS	At 3-months , there was a non-significant difference in change score for FACIT-Sp between intervention and control groups ( 356 points [ 95 % CI -027 to 740 ] , p = 007 ) , a significant difference in QUAL-E ( 225 [ 001 to 449 ] , p = 005 ) and FAMCARE-P16 ( 379 [ 174 to 585 ] , p = 00003 ) , and no difference in ESAS ( -170 [ -526 to 187 ] , p = 033 ) or CARES-MIS ( -066 [ -225 to 094 ] , p = 040 ) .
RESULTS	At 4 months , there were significant differences in change scores for all outcomes except CARES-MIS .
RESULTS	All differences favoured the intervention group .
CONCLUSIONS	Although the difference in quality of life was non-significant at the primary endpoint , this trial shows promising findings that support early palliative care for patients with advanced cancer .
BACKGROUND	Canadian Cancer Society , Ontario Ministry of Health and Long Term Care .

###25842461
OBJECTIVE	To evaluate the 6-month clinical effects of one scaling and root planing ( SRP ) procedure alone or combined with local administration of hydrogen peroxide gel ( with or without inclusion of doxycycline for 2 weeks ) using periodontal medicament carriers in the form of customized prescription trays for treatment of subjects with chronic periodontitis .
METHODS	Using a randomized controlled design , 61 subjects with moderate to advanced periodontitis were assigned to three parallel treatment groups : 1 ) SRP combined with prescription-tray ( Perio Tray ) application of 1.7 % hydrogen peroxide gel ( Perio Gel ) and , for the first 2 weeks , doxycycline , 2 ) SRP combined with prescription-tray application of peroxide gel , and 3 ) SRP alone .
METHODS	All subjects brushed twice daily with standard dentifrice and toothbrush for a 4-week acclimation phase , and continued this regimen throughout the 6-month treatment phase .
METHODS	Pocket probing depth ( PPD ) and bleeding index ( BI ) were assessed on natural and restored sites at baseline and after 2 , 5 , 13 , and 26 weeks .
METHODS	SRP was performed 3 weeks after baseline .
METHODS	Clinical variables were compared by ANCOVA and paired t-tests after each treatment interval , analyzing natural and restored sites separately .
RESULTS	57 subjects completed the trial .
RESULTS	Analysis of pockets > 5 mm at baseline showed that mean PPD for both test groups significantly decreased from baseline approximately 0.50 mm prior to SRP .
RESULTS	Two weeks following SRP , mean PPD significantly decreased from baseline by > 0.90 mm for both test groups and 0.29 mm for the control .
RESULTS	By 26 weeks , mean PPD decreased > 1.10 mm for both test groups compared to 0.38 mm for the SRP-only control ( P < 0.001 for test versus control at all post-SRP comparisons ) .
RESULTS	Analysis of pockets 5 mm at baseline showed the same relationship between groups ( P < 0.001 for test versus control ) .
RESULTS	Mean BI dropped significantly only for test groups before SRP , and the tray/peroxide-doxycycline group was significantly different from the control ( P = 0.033 ) .
RESULTS	Two weeks post-SRP , mean BI reductions for test groups were significantly greater than the control , and remained so for most comparisons .
RESULTS	For restored sites , mean PPDs of both test groups were significantly better ( P < 0.05 ) than the control for all post-baseline comparisons .

###25633544
OBJECTIVE	To identify the effectiveness of rational-emotive-behavior-based therapy ( REBT-based therapy ) on improved mental health and antiretroviral ( ART ) therapeutic adherence in women infected with HIV/AIDS ( female subjects with HIV/AIDS ) .
METHODS	A randomized and single-blinded clinical trial in women infected with HIV/AIDS who had their treatment at the outpatient clinic of Pokdiksus AIDS RSCM and at the AIDS Comprehensive Diagnostic Unit of Dharmais Hospital was conducted between October 2011 and March 2012 .
METHODS	A block randomization of 160 female subjects with AIDS was performed that resulted in a REBT-based treatment group ( n = 80 ) and a control group ( n = 80 ) .
METHODS	The treatment group received REBT-based intervention of 8 sessions weekly including 6 individual-therapeutic sessions/week and 2 group-therapeutic sessions/week .
METHODS	Instruments used in the study were questionnaires on demography , ART adherence ( measured by self report and pill count ) , and mental health ( SRQ-20 ) .
METHODS	Data were analyzed using Chi-Square test , Generalized Linear Model , and Generalized Estimating Equations .
RESULTS	There were 148 respondents analyzed including in the REBT-based group ( n = 72 ) and in the control group ( n = 76 ) with mean age of 33-34 years .
RESULTS	After 8 weeks of REBT-based intervention , there was improved ( increased ) mean value of the self-reported adherence score ( self-report ) compared to control group ( 100 % ; CI 95 % ,83.3 -96.7 vs. 84 % ; CI 95 % ,77.5 -87.8 ) and improved ( decreased ) SRQ-20 mean score in REBT-based treatment group compared to control group ( 2.9 ; CI 95 % , 2.7-13 .0 vs. 5.4 ; CI 95 % : 5.0-13 .6 ) .
RESULTS	ART adherence based on viral load titer was not analyzed in both group since most of VL titer were undetected ( < 400 copies/mL ) .
RESULTS	GLM analysis showed decreased SRQ-20 mean score and increased mean value of self-reported ART adherence ( self-report ) in the REBT-based treatment group , which were more significant ( p < 0.000 ) than control group on the 8th week .
RESULTS	GEE analysis showed that 1 point decrement of SRQ-20 would increase self-reported ART adherence as much as 0.722 point and the correlation was statistically significant ( p < 0.00 ) .
CONCLUSIONS	After 8 weeks of REBT-based intervention to female subjects with HIV/AIDS , there is a decrease of SRQ-20 mean score which may result in increased ART adherence mean score in the treatment group compared to the control .

###26411223
OBJECTIVE	To compare the effects of ultrasonography with laparoscopy on transcervical resection of septa ( TCRS ) .
METHODS	The study included 126 patients with uterine septum at the present hospital between January 2010 and August 2012 that were randomly divided into two groups .
METHODS	Seventy patients had TCRS monitored by ultrasound ( ultrasound group ) while 56 patients were monitored by laparoscope ( laparoscope group ) .
METHODS	Both groups were followed up for six to 24 months .
METHODS	The intraoperative status , short-term and long-term complications after operation , and pregnancy outcome of two groups were compared .
RESULTS	The operations of both groups were successfully completed .
RESULTS	The operating time , the first time to get out of bed , postoperative 24hNRS ( numeric rating scale ) values , postoperative hospital stay , and the incidence of postoperative septum residue of ultrasound group were significantly less than laparoscope group ( p < 0.05 ) .
RESULTS	No statistical differences were observed in intraoperative complications and pregnancy ratio between the two groups .
CONCLUSIONS	Both ultrasound and laparoscope monitored TCRS were safe and effective in the treatment of uterine septum .
CONCLUSIONS	Ultrasound monitored TCRS was more simple , economical , accurate , and non-invasive .
CONCLUSIONS	For patients without abnormal lesions in pelvic cavity , the present authors tend to choose the ultrasound monitored TCRS .

###25007405
OBJECTIVE	To investigate the cost-effectiveness of a rapid response team ( RRT ) , compared with usual care ( UC ) , for treating suicidal adolescents .
METHODS	Suicidal adolescents ( n = 286 ) presenting at an emergency department were enrolled in a trial to compare UC with enhanced outpatient care provided by an RRT of health professionals .
METHODS	Functioning ( Child Global Assessment Scale ) and suicidality ( Spectrum of Suicidal Behavior Scale ) scores were measured at baseline and 6 months later .
METHODS	Resource use and cost data were collected from several sources during the same period .
RESULTS	As previously reported , there was no statistically or clinically significant difference in either functioning or suicidality between the groups .
RESULTS	Costs of the RRT were lower by $ 1886 , thus - $ 1886 ( 95 % CI - $ 4238 to $ 466 ) , from the perspective of the treating hospital , and by $ 991 , thus - $ 991 ( 95 % CI - $ 5580 to $ 3598 ) , from the perspective of society .
RESULTS	If decision makers are not willing to pay for any improvement in functioning or suicidality , the RRT has a 95 % probability of being cost-effective from the perspective of the treating hospital .
RESULTS	From the point of view of society , the probability of the intervention being cost-effective is about 70 % for functioning and 63 % for suicidality .
RESULTS	The difference between the 2 perspectives is mainly attributable to the cost of hospitalizations outside the treating hospital .
CONCLUSIONS	An RRT intervention appears to be cost-effective , compared with UC , from the point of view of the treating hospital , but there is no difference from the point of view of society .

###24464960
OBJECTIVE	The cardio-renal syndrome plays a critical role in acute heart failure ( HF ) .
OBJECTIVE	Levosimendan , an inodilator drug , has a positive but controversial effect on kidney .
OBJECTIVE	Our aim was to evaluate its effects on both renal and systemic haemodynamic parameters as well as on renal function , explaining the possible mechanisms involved .
RESULTS	Patients with acute decompensated HF , moderate renal impairment , wedge pressure > 20mmHg and EF < 40 % were eligible .
RESULTS	Twenty-one patients were randomized to infusion of levosimendan or placebo , on top of standard therapy .
RESULTS	Systemic haemodynamic parameters ( wedge and cardiac output ) were evaluated at baseline and at 8 , 16 , 24 , 48 , and 72h .
RESULTS	An intravascular renal artery Doppler exam was performed at baseline , after levosimendan bolus , and 1h thereafter .
RESULTS	Renal blood flow , glomerular filtration rate ( GFR ) , cystatin C , blood urea nitrogen ( BUN ) , urinary output , sodium excretion , and plasma sodium were measured .
RESULTS	The effect of levosimendan was beneficial and significantly different from placebo on several renal and cardiac parameters .
RESULTS	Specifically , the levosimendan and placebo group exhibited significantly different changes over time in GFR ( P = 0.037 ) , renal blood flow ( P = 0.037 ) , and renal artery diameter ( P = 0.033 ) , with ensuing improvements in serum levels of BUN ( P = 0.014 ) , creatinine ( P = 0.042 ) , and cystatin C ( P = 0.05 ) .
RESULTS	Concomitantly , levosimendan provided a significant increase in urine output up to 72h ( P = 0.02 ) .
RESULTS	These beneficial results on renal parameters were accompanied by similarly significant and favourable changes in cardiac index ( P = 0.029 ) and PCWP ( P < 0.001 ) .
CONCLUSIONS	Levosimendan , in acute decompensated HF , has an immediate renoprotective effect , mediated by an increase in renal blood flow , due to a selective renal arterial and venous vasodilating action .
BACKGROUND	NCT00527059 .

###25675570
OBJECTIVE	To compare the efficacy between elongated needle therapy and regular needle therapy at Tiantu ( CV 22 ) on the basis of xingnao kaiqiao ( activiting brain and regaining consciousness ) acupuncture therapy so as to explore the effective therapeutic method in treatment of dysphagia induced by bulbar palsy .
METHODS	Seventy one cases of dysphagia induced by bulbar palsy were randomized into two groups .
METHODS	The xingnao kaiqiao acupuncture therapy was applied at Shuigou ( GV 26 ) , Neiguan ( PC 6 ) , Sanyinjiao ( SP 6 ) and the others in the two groups .
METHODS	In the elongated needle therapy group , on the basis of xingnao kaiqiao acupuncture therapy , the elongated needle was used to puncture Tiantu ( CV 22 ) .
METHODS	In the regular needle therapy , the regular acupuncture technique was used at Tiantu ( CV 22 ) .
METHODS	In both groups , the treatment was given once a day in a week except Sunday and lasted for 4 weeks totally .
METHODS	Before and after treatment , the swallowing condition and the standardized swallowing assessment ( SSA ) were observed in the patients and the efficacy was compared between the two groups .
RESULTS	The total effective rate was 97.2 % ( 35/36 ) in the elongated needle therapy group , which was better than 77.1 % ( 27/35 ) in the regular needle therapy group ( P < 0.05 ) .
RESULTS	After treatment , SSA score was reduced significantly as compared with that before treatment in the two groups ( both P < 0.05 ) .
RESULTS	SSA score in the elongated needle therapy group was reduced much more apparently as compared with that in the regular needle therapy group after treatment ( P < 0.05 ) .
CONCLUSIONS	On the basis of the xingnao kaiqiao acupuncture therapy , the elongated needle therapy at Tiantu ( CV 22 ) achieves the superior effect on bulbar palsy-induced dysphagia as compared with the regular acu - puncture at Tiantu ( CV 22 ) .

###25548849
BACKGROUND	Botulinum toxin Type A ( BoNT A ) for the treatment of facial wrinkles is delivered through local injection .
BACKGROUND	We previously demonstrated that topical surface application of BoNT A has negligible cutaneous bioavailability and is not effective in treating wrinkles .
OBJECTIVE	To determine the effect of BoNT A solution applied topically on the skin surface immediately after ablative fractional CO2 laser treatment .
METHODS	We conducted a randomized controlled trial for patients with periorbital wrinkles ( crow 's feet ) ( n = 10 ) .
METHODS	Treatment was performed on both sides of the face with fractional ablative CO2 laser followed by the application of topical solutions of BoNT A on one side and normal saline as control on the other side .
METHODS	Pretreatment assessment was performed , and at 1 and 4 weeks after treatment .
RESULTS	There was a clinically significant greater degree of improvement in wrinkles after treatment with CO2 laser , on the topically applied BoNT A side .
RESULTS	Also , the difference between the 2 treatment types ( laser followed by topical BoNT A vs laser followed by saline ) at 1 week and at 1 month was statistically significant .
CONCLUSIONS	Topically , noninjectable form of BoNT A applied on the surface of the skin after ablative fractional CO2 laser is effective in the treatment of lateral periorbital wrinkles .

###24866067
OBJECTIVE	To evaluate the incidence of surgical site infection ( SSI ) based on the type of scalpel used for incisions in the skin and in subcutaneous tissues .
METHODS	Observer-blind , randomized equivalence clinical trial with two arms ( electrocautery versus conventional scalpel ) which evaluated 133 women undergoing elective abdominal gynecologic oncology surgery .
METHODS	A simple randomization stratified by body mass index ( BMI : 30 kg/m ( 2 ) ) was carried out .
METHODS	Women were evaluated at 14 and 30 days following the operation .
METHODS	A multivariate analysis was performed in order to check whether the type of scalpel would be a risk factor for SSI .
RESULTS	Group arms were balanced for all variables , excepted for surgical time , which was significantly higher in the electrocautery group ( mean : 161.1 versus 203.5 min , P = 0.029 ) .
RESULTS	The rates of SSI were 7.4 % and 9.7 % , respectively , for the conventional scalpel and electrocautery groups ( P = 0.756 ) .
RESULTS	The exploratory multivariate model identified body mass index 30 kg/m ( 2 ) ( OR = 24.2 , 95 % CI : 2.8-212 .1 ) and transverse surgical incision ( OR = 8.1 , 95 % CI : 1.5-42 .6 ) as independent risk factors for SSI .
RESULTS	The type of scalpel used in surgery , when adjusted for these variables and the surgery time , was not a risk factor for SSI .
CONCLUSIONS	This study showed that the SSI rates for conventional scalpel and electrocautery were not significantly different .
CONCLUSIONS	These results were consistent with others reported in the literature and would not allow a surgeon to justify scalpel choice based on SSI .
BACKGROUND	NCT01410175 ( Clinical Trials - NIH ) .

###24961903
BACKGROUND	Photophobia and phonophobia are the most prominent symptoms in patients with migraine without aura .
BACKGROUND	Hypersensitivity to visual stimuli can lead to greater hypersensitivity to auditory stimuli , which suggests that the interaction between visual and auditory stimuli may play an important role in the pathogenesis of migraine .
BACKGROUND	However , audiovisual temporal interactions in migraine have not been well studied .
BACKGROUND	Therefore , our aim was to examine auditory and visual interactions in migraine .
METHODS	In this study , visual , auditory , and audiovisual stimuli with different temporal intervals between the visual and auditory stimuli were randomly presented to the left or right hemispace .
METHODS	During this time , the participants were asked to respond promptly to target stimuli .
METHODS	We used cumulative distribution functions to analyze the response times as a measure of audiovisual integration .
RESULTS	Our results showed that audiovisual integration was significantly elevated in the migraineurs compared with the normal controls ( p < 0.05 ) ; however , audiovisual suppression was weaker in the migraineurs compared with the normal controls ( p < 0.05 ) .
CONCLUSIONS	Our findings further objectively support the notion that migraineurs without aura are hypersensitive to external visual and auditory stimuli .
CONCLUSIONS	Our study offers a new quantitative and objective method to evaluate hypersensitivity to audio-visual stimuli in patients with migraine .

###24504804
OBJECTIVE	To evaluate whether chloroquine ( CQ ) is more effective than meloxicam for treating early musculoskeletal pain and arthritis following acute chikungunya ( CHIK ) virus infection .
METHODS	During the 2006 CHIK epidemic , 509 rural community cases of acute CHIK virus infection were identified in the district of Sholapur in India .
METHODS	Seventy consenting adult patients ( seropositive for IgM/IgG anti-CHIK antibody ) with early persistent musculoskeletal pain and arthritis were randomized into a 24-week , 2-arm , parallel efficacy trial of CQ ( 250 mg/day ) and meloxicam ( 7.5 mg/day ) .
METHODS	Assessors completed a rheumatology evaluation in a blinded manner and collected blood samples in the patients ' homes , as per protocol .
METHODS	Laboratory parameters included serum cytokine assay ( interleukin-6 [ IL-6 ] , interferon - [ IFN ] , tumor necrosis factor , CXCL10/IFN-inducible protein 10 , and IL-13 ) .
METHODS	Twenty-two patients who failed to meet the eligibility criteria ( low pain cohort ) were also followed up with similar evaluations .
METHODS	An intent-to-treat analysis was completed .
METHODS	At baseline , the 2 groups ( 38 patients randomized to receive CQ and 32 patients randomized to receive meloxicam ) were well matched .
RESULTS	There were no significant efficacy differences between the meloxicam group and the CQ group ( mean changes in the visual analog scale score for pain -3.9 and -4.2 , respectively ) .
RESULTS	Patients improved significantly .
RESULTS	Cytokine levels remained several-fold increased , were disproportionate to the clinical response , and were not different from those in the low pain cohort .
RESULTS	Seven patients withdrew .
RESULTS	Adverse events were mild and infrequent .
CONCLUSIONS	This exploratory community intervention trial failed to identify an advantage of CQ over meloxicam to treat early musculoskeletal pain and arthritis following acute CHIK virus infection , but therapeutic efficacy of CQ was not ruled out .
CONCLUSIONS	The inflammatory cytokine response was intense and was not consistent with clinical status .

###26011337
OBJECTIVE	This study investigated the impact of early enteral nutrition ( EEN ) on the clinical outcomes of gastric cancer patients after radical gastrectomy .
METHODS	Four hundred gastric cancer patients undergoing radical gastrectomy of any extend with D2 nodal dissection were randomly divided into an experimental and a control group with 200 cases in each group .
METHODS	Patients in the control group received postoperative parenteral nutrition ( PN ) , while patients in the experimental group received postoperative EEN .
METHODS	After treatment , the clinical outcomes , postoperative immune function , and nutritional status of the two groups were evaluated .
RESULTS	The postoperative fever time , intestinal function recovery time , anal exhaust time , and the length of hospital stay for patients in the experimental group were significantly shorter than those of the control group .
RESULTS	We did not find significant differences in anastomotic leak , postoperative ileus and regurgitation between the two groups .
RESULTS	The activities of multiple immune cell types , including CD3 , CD4 , CD4/CD8 , and natural killer ( NK ) cells , were significantly lower in both groups on postoperative day 1 when compared with the preoperative levels ( p < 0.05 ) .
RESULTS	The level of CD8 was not significantly different between the two groups ( p > 0.05 ) .
RESULTS	After treatment , levels of CD3 , CD4 , CD4/CD8 , and NK cells in the experimental group patients were 35.6 4.2 , 42.2 3.0 , 1.7 0.3 , and 27.3 5.3 % , respectively , on postoperative day 7 , which were similar to the preoperative levels .
RESULTS	The immune cell levels from the control group patients remained significantly lower when compared with preoperative values ; in addition , these values were also significantly lower when compared with the EEN patients ( p < 0.05 ) CONCLUSION : For gastric cancer patients undergoing radical gastrectomy , the clinical outcome , immune function and nutritional status after EEN were significantly improved .
RESULTS	These data suggest the widespread use of EEN in clinical practice .

###25422085
BACKGROUND	Severe mentally ill ( SMI ) patients have a reduced life expectancy of 13-30 years compared to the general population , largely due to an increased risk of cardiovascular mortality .
BACKGROUND	Unhealthy lifestyle behaviours in SMI patients contribute to this increased risk .
BACKGROUND	The obesogenic living environment of patients in residential facilities may even pose an extra risk .
BACKGROUND	Although several studies have shown positive effects of lifestyle interventions on SMI patients ' weight status , studies including residential patients and their obesogenic environment are scarce .
BACKGROUND	This paper describes the Effectiveness of Lifestyle Interventions in PSychiatry trial ( ELIPS ) .
BACKGROUND	The goal of this trial is to improve cardiometabolic health in severe mentally ill residential patients by addressing the obesogenic environment .
METHODS	The ELIPS study is a multi-site cluster randomised controlled trial ( RCT ) based on the principles of a pragmatic RCT .
METHODS	All residential and long-term clinical care teams of two large mental health care organisations in the North of the Netherlands serving SMI patients are invited to participate .
METHODS	The intervention is aimed at team level .
METHODS	Lifestyle coaches first develop a team specific lifestyle plan that tailors the ELIPS goals and protocol and then train teams on how to create a healthy environment and stimulate healthy behaviours in patients .
METHODS	After three months , teams take over the intervention after they have set out goals to achieve in the following nine months .
METHODS	In this phase , adherence to the lifestyle plan and pre-set goals is monitored .
METHODS	Patients in the control arm receive care as usual .
METHODS	Primary outcome measure is waist circumference at three and 12months after baseline .
CONCLUSIONS	ELIPS is different from previously published lifestyle intervention studies in three ways .
CONCLUSIONS	First , it follows the principles of a pragmatic design , which enables the examination of effects in everyday practice .
CONCLUSIONS	Second , by implementing the intervention at team level , we expect lifestyle activities to be maintained when interventionists leave .
CONCLUSIONS	Last , by targeting the obesogenic environment we create a prerequisite for any sustainable health improvement , as patients can only make healthy choices in a healthy living environment .
BACKGROUND	Nederlands Trialregister NTR2720 ( Dutch Trial Register , www.trialregister.nl ) .
BACKGROUND	Registered 27 January 2011 .

###25361165
BACKGROUND	Crotalidae Polyvalent Immune Fab ( Ovine ) has been the only antivenom commercially available in the US since 2007 for treatment of Crotalinae envenomation .
BACKGROUND	Late coagulopathy can occur or recur after clearance of Fab antivenom , often after hospital discharge , lasting in some cases more than 2 weeks .
BACKGROUND	There have been serious , even fatal , bleeding complications associated with recurrence phenomena .
BACKGROUND	Frequent follow-up is required , and additional intervention or hospitalization is often necessary .
BACKGROUND	F ( ab ' ) 2 immunoglobulin derivatives have longer plasma half life than do Fab .
BACKGROUND	We hypothesized that F ( ab ' ) 2 antivenom would be superior to Fab in the prevention of late coagulopathy following treatment of patients with Crotalinae envenomation .
METHODS	We conducted a prospective , double-blind , randomized clinical trial , comparing late coagulopathy in snakebitten patients treated with F ( ab ' ) 2 with maintenance doses [ F ( ab ' ) 2/F ( ab ' ) 2 ] , or F ( ab ' ) 2 with placebo maintenance doses [ F ( ab ' ) 2/placebo ] , versus Fab with maintenance doses [ Fab/Fab ] .
METHODS	The primary efficacy endpoint was coagulopathy ( platelet count < 150 K/mm ( 3 ) , fibrinogen level < 150 mg/dL ) between end of maintenance dosing and day 8 .
RESULTS	121 patients were randomized at 18 clinical sites and received at least one dose of study drug .
RESULTS	114 completed the study .
RESULTS	Of these , 11/37 ( 29.7 % ) in the Fab/Fab cohort experienced late coagulopathy versus 4/39 ( 10.3 % , p < 0.05 ) in the F ( ab ' ) 2/F ( ab ' ) 2 cohort and 2/38 ( 5.3 % , p < 0.05 ) in the F ( ab ' ) 2/placebo cohort .
RESULTS	The lowest heterologous protein exposure was with F ( ab ' ) 2/placebo .
RESULTS	No serious adverse events were related to study drug .
RESULTS	In each study arm , one patient experienced an acute serum reaction and one experienced serum sickness .
CONCLUSIONS	In this study , management of coagulopathic Crotalinae envenomation with longer-half-life F ( ab ' ) 2 antivenom , with or without maintenance dosing , reduced the risk of subacute coagulopathy and bleeding following treatment of envenomation .

###25547064
OBJECTIVE	Efficacy of the conventional - versus high-dose vancomycin regimen in patients with acute bacterial meningitis was compared .
METHODS	In a randomized clinical trial 44 patients with acute bacterial meningitis were randomly assigned to the conventional - or high-dose vancomycin groups .
METHODS	Clinical and laboratory parameters were used for evaluation of response to the treatment regimens .
RESULTS	In the high-dose group , leukocytosis and fever resolved significantly faster than those in the conventional group .
RESULTS	Furthermore , the length of hospitalization was shorter and Glasgow Coma Scale at the end of 10th day was significantly lower in the high dose compared to the conventional group .
RESULTS	Trend of creatinine clearance changes did not differ significantly between the two groups .
CONCLUSIONS	In comparison to the conventional-dose regimen , the high-dose vancomycin regimen was associated with significantly more favorable clinical response without increase in the incidence of nephrotoxicity in patients with acute bacterial meningitis .

###24760537
OBJECTIVE	Cushing 's disease ( CD ) can significantly impair patients ' health-related quality of life ( HRQOL ) .
OBJECTIVE	This study investigated the treatment effectiveness of pasireotide on HRQOL of CD patients , and assessed the relationships between HRQOL and urinary free cortisol ( UFC ) and CD-related signs and symptoms .
METHODS	In this phase III , randomized , double-blind study , patients with UFC 1.5 upper limit of normal ( ULN ) received s.c. pasireotide 600 or 900g twice daily .
METHODS	The trial primary endpoint was UFC at or below ULN at month 6 without dose titration .
METHODS	Open-label treatment continued through month 12 .
METHODS	HRQOL was measured using the Cushing 's Quality of Life Questionnaire ( CushingQoL ) instrument at baseline and follow-up visits until month 12 during which clinical signs and features of CD , and the Beck Depression Inventory II ( BDI-II ) , were also collected .
METHODS	Pearson 's / Spearman 's correlations between changes in CushingQoL and changes in clinical signs and symptoms were assessed .
METHODS	Changes in CushingQoL and the proportion of patients achieving a clinically meaningful improvement in CushingQoL were also compared among patients stratified by mean UFC ( mUFC ) control status ( controlled , partially controlled , and uncontrolled ) at month 6 .
METHODS	Analyses were also conducted at month 12 , with multivariable adjustment for baseline characteristics and CushingQoL .
RESULTS	Change in CushingQoL was significantly correlated with changes in mUFC ( r = -0.40 ) , BMI ( r = -0.39 ) , weight ( r = -0.41 ) , and BDI-II ( r = -0.54 ) at month 12 but not at month 6 .
RESULTS	The percentage of CushingQoL responders at month 12 based on month 6 mUFC control status were as follows : 63 , 58.8 , and 37.9 % in the controlled , partially controlled , and uncontrolled groups respectively .
RESULTS	Adjusted CushingQoL scores at month 12 were 58.3 for controlled patients ( = 11.5 vs uncontrolled , P = 0.012 ) and 54.5 for partially controlled patients ( = 7.7 vs uncontrolled , P = 0.170 ) .
CONCLUSIONS	Pasireotide treatment can result in a meaningful HRQOL improvement among those who complete a 12-month treatment period , most often among patients achieving biochemical control .

###24731890
BACKGROUND	Prenatal maternal stress is associated with adverse birth outcomes .
BACKGROUND	Relaxation techniques might be effective in reducing stress during that period .
BACKGROUND	The purpose of this study was to evaluate the effects of applied relaxation in reducing anxiety and stress in pregnant women in their second trimester , as well as raising their sense of control .
BACKGROUND	Also we expected to see a difference in some lifestyle factors associated with stress .
BACKGROUND	A randomized control trial with a prospective pretest-posttest experimental design was used .
METHODS	Sixty primigravida women in their second trimester were assigned randomly to receive a 6-week stress management programme ( N = 31 ) ( relaxation breathing and progressive muscle relaxation , RB-PMR , twice a day ) or not ( N = 29 ) .
METHODS	Self-reported validated measures were used to evaluate perceived stress , health locus of control and anxiety at baseline and at the end of the 6-weeks follow-up .
RESULTS	The results of the study demonstrated significant benefits from the use of the techniques in the psychological state of the pregnant women .
RESULTS	The systematic implementation of the proposed relaxation techniques contributed in the reduction of perceived stress ( mean change -3.23 , 95 % CI : -4.29 to -0.29 ) and increased the sense of control ( mean change 1.99 , 95 % CI : 0.02-3 .7 ) .
CONCLUSIONS	The findings suggest beneficial effects of relaxation on reducing perceived stress as well as increment of sense of control in pregnant women .
CONCLUSIONS	The results of this study support the claim that training in the proposed relaxation techniques may constitute an ideal , non-pharmaceutical , intervention that can promote well-being , at least during pregnancy .
CONCLUSIONS	Longer studies will be necessary in the future , in order to examine the long-term effects of relaxation techniques .

###25156528
BACKGROUND	This study examined mediators and moderators of short-term treatment effectiveness from the iQUITT Study ( Quit Using Internet and Telephone Treatment ) , a 3-arm randomized trial that compared an interactive smoking cessation Web site with an online social network ( enhanced Internet ) alone and in conjunction with proactive telephone counseling ( enhanced Internet plus phone ) to a static Internet comparison condition ( basic Internet ) .
METHODS	The analytic sample was N = 1,236 participants with complete 3-month data on all mediating variables .
METHODS	The primary outcome was 30-day point prevalence abstinence ( ppa ) at 3 months .
METHODS	Recognizing the importance of temporal precedence in mediation analyses , we also present findings for 6-month outcomes .
METHODS	Purported mediators were treatment utilization and changes in psychosocial constructs .
METHODS	Proposed moderators included baseline demographic , smoking , and psychosocial variables .
METHODS	Mediation analyses examined the extent to which between-arm differences in 30-day ppa could be attributed to differential Web site utilization , telephone counseling , and associated changes in smoking self-efficacy and social support for quitting .
METHODS	Effect modification analyses fitted interactions between treatment and prespecified moderators on abstinence .
RESULTS	Significant mediators of 30-day ppa were changes in smoking temptations , quitting confidence , and positive and negative partner support , which were strongly associated with increased Web site utilization .
RESULTS	The addition of telephone counseling to an enhanced Web site further improved abstinence rates , partly via an association with increased quitting confidence .
RESULTS	Baseline smoking rate was the only significant moderator .
CONCLUSIONS	Increased treatment utilization and associated changes in several psychosocial measures yielded higher abstinence rates .
CONCLUSIONS	Findings validate the importance of treatment utilization , smoking self-efficacy , and social support to promote abstinence .

###25219946
BACKGROUND	Ayurveda ( Indian-complimentary and alternative medicine ) is still most sought after in India and has promising potential in management of Vishada [ major depressive disorder ( MDD ) ] .
BACKGROUND	But , systematic research is lacking .
BACKGROUND	In this study we evaluated of influence of ayurvedic treatment ( Panchakarma and Ayushman-15 ) on psychopathology , heart rate variability ( HRV ) and endocrinal parameters in patients with major depression .
METHODS	81 drug naive patients diagnosed as Vishada by ayurvedic physician and MDD according to DSM IV-TR were given ayurvedic Virechana module ( therapeutic purgation ) and were randomized into two groups .
METHODS	Patients in group A ( n = 41 ) received Ayushman-15A while group B ( n = 40 ) received Ayushman-15B for two months and Shirodhara ( forehead-oil pouring therapy ) .
METHODS	Patients were assessed with Hamilton Depression Rating Scale ( HDRS ) , Montgomery Asberg Depression Rating Scale ( MADRS ) , Heart Rate Variability ( HRV ) .
METHODS	Cortisol and adrenocorticotropic hormone ( ACTH ) were estimated at baseline and after ayurvedic therapy .
METHODS	HRV and endocrinal parameters were compared with age and gender matched healthy volunteers .
RESULTS	HRV parameters showed significant sympathetic dominance in patients compared to healthy volunteers .
RESULTS	Two months of ayurvedic treatment significantly decreased psychopathology , showed increase in vagal tone , decrease in sympathetic tone and reduced cortisol levels .
RESULTS	However , there was no significant difference between groups receiving Ayushman A and B.
CONCLUSIONS	This study provides evidence for antidepressant , cardiac ( HRV ) and beneficial neuroendocrine modulatory influence of Ayurveda therapy in patients of Vishada ( MDD ) .
CONCLUSIONS	Further studies are needed to confirm these findings .
CONCLUSIONS	Greater insight into the neurobiology behind this therapy might provide valuable information about newer drug target .

###24461045
BACKGROUND	Gestational diabetes mellitus ( GDM ) is a risk factor for the development of type 2 diabetes .
BACKGROUND	Lifestyle intervention can prevent progression to type 2 diabetes in high risk populations .
BACKGROUND	We designed a randomised controlled trial ( RCT ) to evaluate the effectiveness of an established lifestyle intervention compared to standard care for delaying diabetes onset in European women with recent GDM .
BACKGROUND	Recruitment into the RCT was more challenging than anticipated with only 89 of 410 ( 22 % ) women agreeing to participate .
BACKGROUND	This paper identifies factors that could enhance participation of the target population in future interventions .
METHODS	We hypothesised that women who agreed to participate would have higher diabetes risk profiles than those who declined , and secondly that it would be possible to predict participation on the bases of those risk factors .
METHODS	To test our hypothesis , we identified the subset of women for whom we had comprehensive data on diabetes risks factors 3-5 years following GDM , reducing the sample to 43 participants and 73 decliners .
METHODS	We considered established diabetes risk factors : smoking , daily fruit and vegetable intake , participation in exercise , family history of diabetes , glucose values and BMI scores on post-partum re-screens , use of insulin during pregnancy , and age at delivery .
METHODS	We also analysed narrative data from 156 decliners to further understand barriers to and facilitators of participation .
RESULTS	Two factors differentiated participants and decliners : age at delivery ( with women older than 34 years being more likely to participate ) and insulin use during pregnancy ( with women requiring the use of insulin in pregnancy less likely to participate ) .
RESULTS	Binary logistic regression confirmed that insulin use negatively affected the odds of participation .
RESULTS	The most significant barriers to participation included the accessibility , affordability and practicality of the intervention .
CONCLUSIONS	Women with recent GDM face multiple barriers to lifestyle change .
CONCLUSIONS	Intervention designers should consider : ( i ) the practicalities of participation for this population , ( ii ) research designs that capitalise on motivational differences between participants , ( iii ) alleviating concerns about long-term diabetes management .
CONCLUSIONS	We hope this work will support future researchers in developing interventions that are more relevant , effective and successful in recruiting the desired population .
BACKGROUND	Current Controlled Trials ISRCTN41202110 .

###24780946
OBJECTIVE	This study aimed to evaluate the effects of phyto-supplements on hyperlipidemia .
METHODS	For this study 191 patients , affected by hyperlipidemia , attending the Outpatient Clinics of Clinical Medicine Department , were recruited .
METHODS	The patients were divided in two groups .
METHODS	The first group ( 80 ) has been treated with hypolipidic diet for six months ( group D ) .
METHODS	The second one ( 111 ) has been administered with hypolipidic diet and supplement ( red yeast , guggulsterones , flavonoid , sylimarin ) ( group E ) .
METHODS	Anthropometric measurements and bioimpedance analysis were evaluated before and after treatment .
METHODS	Moreover , total cholesterol , LDL , HDL , triglycerides ( TG ) and hepatic transaminases ( AST , ALT ) were measured before , after 3 and 6 months of treatment .
RESULTS	D group showed a significant reduction in BMI ( 32.6 0.7 vs. 34.3 0.7 kg/m ) , waist circumference ( 104.4 1.6 vs. 108.3 1.5 cm ) , hip circumference ( 107.9 1.1 vs. 111.2 1.1 cm ) , total cholesterol ( 214.2 3.7 vs. 236.6 2.2 mg/dL , -9.4 68.2 % ) , LDL cholesterol ( 133 3 vs. 152.9 2.8 mg/dL , -13 7.1 % ) .
RESULTS	E group showed a significant reduction in BMI ( 30.2 0.7 vs. 32.6 0.6 kg/m ) , waist circumference ( 94.5 1.6 vs. 101.3 1.3 cm ) , hip circumference ( 106.6 1.1 vs. 110.5 1 cm ) , total cholesterol ( 212.4 3.7 vs. 256.9 2.1 mg/dL , -17.3 76.2 % ) , LDL cholesterol ( 133.4 3.4 vs. 168.4 2.3 mg/dL , -20.8 47.8 % ) .
CONCLUSIONS	Low fat diet , associated to phyto-substance supplement , have been proven useful to decrease serum cholesterol level and to improve nutritional status .

###24557326
OBJECTIVE	Long-lasting low back pain is an increasing problem , and for some patients surgery is the final option for improvement .
OBJECTIVE	Several techniques for spinal fusion are available and the optimal technique remains uncertain .
OBJECTIVE	The objective of this study was to assess the cost-effectiveness and cost-utility of transforaminal lumbar interbody fusion ( TLIF ) compared to posterolateral instrumented fusion ( PLF ) from the societal perspective .
METHODS	100 Patients were randomized to TLIF or PLF ( 51/49 ) and followed for 2years .
METHODS	Cost data were acquired from national registers , and outcomes were measured using the Oswestry Disability Index and SF-6D questionnaires .
METHODS	Conventional cost-effectiveness methodology was employed to estimate net benefit and to illustrate cost-effectiveness acceptability curves .
METHODS	The statistical analysis was based on means and bootstrapped confidence intervals .
RESULTS	Results showed no statistically significant difference in either cost or effects although a tendency for the TLIF regimen being more costly on bed days ( <euro> 2,554 ) and production loss ( <euro> 1,915 ) was observed .
RESULTS	The probability that TLIF would be cost-effective did not exceed 30 % for any threshold of willingness to pay per quality-adjusted life year .
RESULTS	Sensitivity analysis was conducted and supported the statistical model for handling of missing data .
CONCLUSIONS	TLIF does not seem to be a relevant alternative to PLF from a socioeconomic , societal point of view .

###24321801
BACKGROUND	According to international treatment guidelines , inhaled rapid-acting 2 agonists should be used for the control of symptoms in patients with asthma .
BACKGROUND	We compared the efficacy and safety of an extrafine combination inhaler containing a corticosteroid ( beclometasone ) plus a rapid-onset , long-acting 2 agonist ( formoterol ) with a short-acting 2 agonist ( salbutamol ) as reliever strategies in patients taking beclometasone-formoterol combination as maintenance treatment .
METHODS	In a double-blind trial undertaken in 183 centres in 14 European countries over 48 weeks , patients ( aged 18 years ) with asthma that was not fully controlled , with a forced expiratory volume in 1 s ( FEV1 ) of at least 60 % predicted , had a 2-week run in .
METHODS	During this period , patients were treated with a combination of beclometasone 100 g and formoterol 6 g per one inhalation twice daily plus salbutamol 100 g as required delivered by use of a pressurised metered-dose inhaler .
METHODS	They were then randomly assigned in a 1:1 ratio with a computer-generated randomisation list to receive beclometasone 100 g plus formoterol 6 g or salbutamol 100 g as reliever in addition to maintenance with beclometasone 100 g plus formoterol 6 g twice daily .
METHODS	Primary outcome was the time to first severe exacerbation ( admission to hospital or visit to emergency department , or use of systemic steroids for 3 consecutive days ) .
METHODS	Secondary outcomes were number of severe exacerbations ( events per 100 patients per year ) , time to and number of mild exacerbations , additional exacerbation variables , lung function , symptom scores , and asthma control .
METHODS	Analysis was by intention to treat .
METHODS	The study is registered with ClinicalTrials.gov , number NCT00861926 .
RESULTS	1714 patients were randomly assigned to the as-needed beclometasone-formoterol ( n = 857 ) and as-needed salbutamol groups ( n = 857 ) , and 1701 were analysed ( 852 and 849 , respectively ) .
RESULTS	326 severe exacerbations were reported by 251 patients during the study , and 99 versus 152 patients had at least one exacerbation during the 48 weeks , respectively .
RESULTS	Compared with beclometasone-formoterol plus salbutamol as needed , beclometasone-formoterol for both maintenance and reliever treatment significantly increased the time to first exacerbation ( 209 days vs 134 days ) by 75 days , with a 36 % reduction in risk ( hazard ratio 064 [ 95 % CI 049 to 082 ] ; p = 00005 ) , and the estimated probability was 12 % and 18 % , respectively ( p = 00003 ) .
RESULTS	The number of days with mild asthma exacerbations was also lower with as-needed beclometasone-formoterol than with as-needed salbutamol ( 5604 days per patient per year vs 6511 days per patient per year ; 086 [ 076 to 098 ] ; p = 0021 ) .
RESULTS	From the run-in period to week 48 , both treatments improved symptoms ( mean change -159 [ -194 to -125 ] in the as-needed beclometasone-formoterol group vs -144 [ -178 to -110 ] in the as-needed salbutamol group , difference -015 [ -060 to 030 ] ; p = 0507 ) , percentage of asthma control days ( 95 % [ 73 to 118 ] vs 109 % [ 87 to 131 ] , respectively , -14 [ -43 to 16 ] ; p = 0359 ) , use of reliever ( -029 [ -038 to -020 ] vs -027 [ -036 to -019 ] , respectively , -002 [ -013 to 010 ] ; p = 0794 ) , and lung function ( FEV1 , 0090 [ 0060 to 0120 ] vs 0090 [ 0060-0120 ] , respectively , 0001 [ -0040 to 0040 ] ; p = 0969 ) , and were well tolerated ( patients with serious adverse events , 32 [ 4 % ] and 41 [ 5 % ] , respectively ) .
CONCLUSIONS	Our results lend support to the use of the combination of a single inhaled corticosteroid plus a rapid-onset , long-acting 2 agonist for maintenance and relief in patients with moderate to severe asthma and provide encouraging data for the formulation of beclometasone-formoterol for this use .
BACKGROUND	Chiesi Farmaceutici .

###24282872
OBJECTIVE	To compare the delivery and retention of triclosan in dental plaque , and to compare the antibacterial efficacy of a newly developed toothpaste to a marketed calcium carbonate toothpaste .
METHODS	Two clinical delivery/retention studies were carried out to determine the concentration of triclosan in plaque 10 minutes , and two and four hours after brushing with a new triclosan-containing toothpaste with magnesium aluminium silicate or a marketed triclosan-containing toothpaste .
METHODS	Both studies had a double-blind , randomized , complete cross-over design .
METHODS	Supragingival plaque samples ( minimum 2 microg ) were taken from smooth surfaces of all teeth ( 1-7 ) in all four quadrants for the 10-minute plaque measurements and in two randomly allocated quadrants at the two - and four-hour time points .
METHODS	Triclosan concentration was measured by HPLC .
METHODS	Antibacterial efficacy was evaluated in vitro using a biofilm formation approach .
METHODS	Three replicate experiments were carried out to check for repeatability and consistency of the assay .
METHODS	Toothpaste slurries were prepared by stirring one part by weight of each toothpaste with two parts by weight of deionized water .
METHODS	An overnight culture suspension of Streptococcus mutans ( ATCC 25175 ) was prepared and then adjusted to give a bacterial count of approximately 10 ( 7 ) CFU/ml .
METHODS	Sterile HAP discs were used as substrate and treated with the toothpaste slurry before inoculation with the standardized culture suspension of S. mutans .
METHODS	Following incubation in brain heart infusion ( BHI ) broth containing 2 % sucrose for four hours , standard Total Viable Count ( TVC ) procedures were carried out and colonies counted ( log10 values ) .
RESULTS	Brushing with the new calcium carbonate/triclosan toothpaste resulted in a higher triclosan concentration in plaque after 10 minutes , and two and four hours compared to a marketed triclosan toothpaste .
RESULTS	The increase ranged from 14 % to 35 % and was statistically significant ( p < 0.05 ) .
RESULTS	The antibacterial efficacy of the new calcium carbonate/triclosan toothpaste , measured four hours after application , was greater than that of a marketed toothpaste with 0.3 % triclosan .
RESULTS	The difference was statistically significant ( p < 0.05 ) .
CONCLUSIONS	The new calcium carbonate toothpaste with 0.3 % triclosan and magnesium aluminium silicate demonstrated significantly greater efficacy four hours post-brushing both in terms of in vivo delivery and in vitro antibacterial action compared to a marketed calcium carbonate toothpaste with 0.3 % triclosan .

###24325594
OBJECTIVE	Children with congenital hemiparesis have unilateral upper extremity involvement , limiting their ability in unilateral or bilateral manual tasks , thus negatively influencing their participation in daily activities .
OBJECTIVE	Constraint-induced movement therapy ( CIMT ) has been shown to be promising for improving upper-limb functions in children with cerebral palsy .
OBJECTIVE	Clinical assessments may be needed to quantify and qualify changes in children 's performance following its application .
METHODS	This study investigated the effectiveness of a child-friendly form of CIMT to improve upper extremity functional performance .
METHODS	Thirty congenitally hemiparetic children aged 4-8 years were randomly assigned to receive either a CIMT program ( study group ) or a conventional non-structured therapy program ( control group ) .
METHODS	The programs were applied for both groups for six hours daily , five days weekly for four successive weeks .
METHODS	The Pediatric Arm Function Test , Quality of Upper Extremity Skills Test , and isokinetic muscular performances of shoulder flexors , extensors , and abductors expressed as peak torque were used to evaluate immediate and long-lasting efficacy of CIMT .
RESULTS	The results showed improvement in the involved upper extremity performances in different evaluated tasks immediately post-CIMT program application compared with the control group .
RESULTS	These improvements continued three months later .
CONCLUSIONS	Pediatric CIMT with shaping produced considerable and sustained improvement in the involved upper extremity movements and functions in children with congenital hemiparesis .

###25346155
BACKGROUND	While opioids provide effective analgesia , opioid-induced constipation ( OIC ) can severely impact quality of life and treatment compliance .
BACKGROUND	This pooled analysis evaluated the maintenance of efficacy and safety during long-term treatment with combined oxycodone/naloxone prolonged-release tablets ( OXN PR ) in adults with moderate-to-severe chronic pain .
METHODS	Patients ( N = 474 ) received open-label OXN PR during 52-week extension phases of two studies , having completed 12-week , double-blind , randomized treatment with oxycodone prolonged-release tablets ( Oxy PR ) or OXN PR .
METHODS	Analgesia and bowel function were assessed at each study visit using ` Average pain over last 24h scale and Bowel Function Index ( BFI ) , respectively .
METHODS	Treatment Satisfaction Questionnaire for Medication was assessed at study end only .
RESULTS	Improvement in bowel function was particularly marked in patients who switched from Oxy PR in the double-blind phase to OXN PR during the extension phase , resulting in a clinically meaningful reduction ( 12 points ) in BFI score : at the start of the extension phases , mean ( SD ) BFI score was 44.3 ( 28.13 ) , and was 29.8 ( 26.36 ) for patients who had received OXN PR in the double-blind phase .
RESULTS	One week later , BFI scores were similar for the two groups ( 26.5 [ 24.40 ] and 27.5 [ 25.60 ] , respectively ) , as was observed throughout the following months .
RESULTS	Fewer than 10 % of patients received laxatives regularly .
RESULTS	Mean 24-h pain scores were low and stable throughout the extension phases .
RESULTS	No unexpected adverse events were observed .
CONCLUSIONS	Pooled data demonstrate OXN PR is an effective long-term therapy for patients with chronic non-cancer pain , and can address symptoms of OIC .
CONCLUSIONS	No new safety issues were observed which were attributable to the long-term administration of OXN PR .

###24344160
OBJECTIVE	To assess pooled golimumab safety up to year 3 of rheumatoid arthritis ( RA ) , psoriatic arthritis ( PsA ) and ankylosing spondylitis ( AS ) trials .
METHODS	Golimumab 50 and 100 mg , administered subcutaneously ( SC ) every 4 weeks ( q4wk ) , were assessed in patients with active RA ( methotrexate-nave , methotrexate-experienced and anti-TNF ( tumour necrosis factor ) - experienced ) , PsA or AS , despite conventional therapy .
METHODS	Placebo control continued up to week ( wk ) 24 ( wk 52 , methotrexate-nave ) , with early escape at wk 16 ( wk 28 , methotrexate-nave ) ; subsequently , all patients received golimumab 50 or 100 mg q4wk .
METHODS	After the blinded controlled period , golimumab doses could be adjusted per investigator discretion .
METHODS	Pooled safety analyses reported herein include data from placebo-controlled and uncontrolled study periods up to wk 160 .
METHODS	Determinations of incidences/100 patient-years ( pt-yrs ) for rare events also included RA patients from a phase IIb trial .
RESULTS	Across five phase III trials of SC golimumab , 639 patients received placebo and 2226 received golimumab 50 mg ( n = 1249 ) and/or 100 mg ( n = 1501 ) up to wk 160 ( patients may be included in more than one group because non-responders were allowed early escape ) ; 1179 patients were treated for 156 weeks .
RESULTS	For placebo , golimumab 50 mg and golimumab 100 mg , respective adverse event incidences/100 pt-yrs ( 95 % CIs ) up to wk 160 were : 0.28 ( 0.01 to 1.56 ) , 0.30 ( 0.12 to 0.62 ) , 0.41 ( 0.23 to 0.69 ) for death ; 5.31 ( 3.20 to 8.30 ) , 3.03 ( 2.36 to 3.82 ) , 5.09 ( 4.36 to 5.90 ) for serious infection ; 0.00 ( 0.00 to 0.84 ) , 0.17 ( 0.05 to 0.44 ) , 0.35 ( 0.18 to 0.62 ) for tuberculosis ; 0.00 ( 0.00 to 0.84 ) , 0.13 ( 0.03 to 0.38 ) , 0.24 ( 0.10 to 0.46 ) for opportunistic infection ; 0.00 ( 0.00 to 0.84 ) , 0.00 ( 0.00 to 0.13 ) , 0.12 ( 0.03 to 0.30 ) for demyelination ; and 0.00 ( 0.00 to 0.84 ) , 0.04 ( 0.00 to 0.24 ) , 0.18 ( 0.06 to 0.38 ) for lymphoma .
CONCLUSIONS	SC golimumab safety up to 3 years remained consistent with that of other TNF antagonists .
CONCLUSIONS	Golimumab 100 mg showed numerically higher incidences of serious infections , demyelinating events and lymphoma than 50 mg ; safety follow-up up to year 5 continues .

###24320690
OBJECTIVE	This study investigates the effect of aerobic interval training on diastolic function at rest and during exercise in stable heart transplant ( HTx ) recipients .
METHODS	Twenty-three stable HTx recipients ( 74 % males , mean age 50 14.9 years ) were recruited to a training programme .
METHODS	Intervention was 8 weeks intensive training or control in a randomized controlled design .
RESULTS	At baseline , participants had normal or mild diastolic dysfunction at rest .
RESULTS	During exercise , mean E/e ' increased from 9.0 ( 2.8 ) to 12.8 ( 7.7 ) ( p = 0.09 ) , E/A increased from 2.1 ( 0.6 ) to 2.6 ( 0.7 ) ( p = 0.02 ) , and deceleration time decreased by over 50 ms , all markers of increased filling pressure .
RESULTS	There were no correlations between diastolic function and VO 2 peak at baseline .
RESULTS	After intervention VO 2 peak increased from 23.9 ( 4.5 ) to 28.3 ( 6 ) ml/kg/min in the training group ( difference between groups p = 0.0018 ) .
RESULTS	No consistent pattern of improvement in diastolic function at rest or during exercise was seen .
CONCLUSIONS	The study does not support a role of diastolic dysfunction in the limited exercise capacity of HTx recipients and suggests that in these patients peripheral factors are of greater importance .

###24235824
BACKGROUND	Pulmonary rehabilitation ( PR ) is a multidisciplinary program of care for patients with chronic obstructive pulmonary disease ( COPD ) with the goal of improving the functional capacity and quality of life , as well as maintaining the clinical stability of COPD sufferers .
BACKGROUND	However , not all patients are available for such a program despite discomfort with their condition .
BACKGROUND	The aim of this study was to evaluate the effects of a home-based PR ( HBPR ) program on functional ability , quality of life , and respiratory muscle strength and endurance .
METHODS	Patients with COPD according to the Global Initiative of Chronic Obstructive Lung Disease were randomized ( double-blind ) into two groups .
METHODS	One group performed a protocol at home with aerobic and muscle strength exercises and was called the intervention group ; the other group received only instructions to perform breathing and stretching exercises , characterizing it as the control group ( CG ) .
METHODS	We assessed the following variables at baseline and 2 months : exercise tolerance ( incremental shuttle walk test and upper limb test ) , respiratory muscle ( strength and endurance test ) , and health-related quality of life ( Airways Questionnaire 20 ) .
RESULTS	There were no significant changes after the intervention in either of the two groups in exercise tolerance and quality of life .
RESULTS	However , the intervention group had improved respiratory endurance compared with the CG , while the CG presented a decrease in the load sustained by the respiratory muscles after the HBPR .
CONCLUSIONS	A program of HBPR with biweekly supervision ( although not enough to provide significant improvements in physical capacity or quality of life ) played an important role in maintaining the stability of the clinical features of patients with COPD ; the patients had no worsening of symptoms during the intervention period according to the daily log .

###25187524
OBJECTIVE	The pattern of atrial fibrillation ( AF ) occurrence-paroxysmal , persistent , or permanent-is associated with progressive stages of atrial dysfunction and structural changes and may therefore be associated with progressively higher stroke risk .
OBJECTIVE	However , previous studies have not consistently shown AF pattern to predict stroke but have been hampered by methodological shortcomings of low power , variable event ascertainment , and variable anticoagulant use .
RESULTS	We analysed the rates of stroke and systemic embolism in 6563 aspirin-treated patients with AF from the ACTIVE-A/AVERROES databases .
RESULTS	There was thorough searching for events and adjudication .
RESULTS	Multivariable analyses were performed with the adjustment for known risk factors for stroke .
RESULTS	Mean age of patients with paroxysmal , persistent , and permanent AF was 69.0 9.9 , 68.6 10.2 , and 71.9 9.8 years ( P < 0.001 ) .
RESULTS	The CHA2DS2-VASc score was similar in patients with paroxysmal and persistent AF ( 3.1 1.4 ) , but was higher in patients with permanent AF ( 3.6 1.5 , P < 0.001 ) .
RESULTS	Yearly ischaemic stroke rates were 2.1 , 3.0 , and 4.2 % for paroxysmal , persistent , and permanent AF , respectively , with adjusted hazard ratio of 1.83 ( P < 0.001 ) for permanent vs. paroxysmal and 1.44 ( P = 0.02 ) for persistent vs. paroxysmal .
RESULTS	Multivariable analysis identified age 75 year , sex , history of stroke or TIA , and AF pattern as independent predictors of stroke , with AF pattern being the second strongest predictor after prior stroke or TIA .
CONCLUSIONS	In a large population of non-anticoagulated AF patients , pattern of AF was a strong independent predictor of stroke risk and may be helpful to assess the risk/benefit for anticoagulant therapy , especially in lower risk patients .

###24620828
OBJECTIVE	In the process of behaviour change , intonation of speech is an important aspect that may influence persuasion when auditory messages are used .
OBJECTIVE	In two experiments , we tested to what extent different levels of intonation are related to persuasion and whether for some recipients the threat posed by the message information might become too strong to face .
METHODS	In Study 1 , 130 respondents listened to a health message with either a low , moderate or high level of intonation .
METHODS	In Study 2 ( N = 143 ) , the same manipulations of intonation were applied but half of the respondents were affirmed before they listened to the persuasive message .
METHODS	Intention to increase fruit and vegetable intake was used as a dependent variable .
RESULTS	Both studies showed that high intonation led to a significant drop in intention among respondents who perceived their own health as good .
RESULTS	After self-affirmation , persuasion was increased .
CONCLUSIONS	A high level of intonation seems to induce self-regulatory defences in people who do not see the necessity to change their health behaviour , whereas people with poor perceived health might perceive potential to change .
CONCLUSIONS	The use of a normal level of intonation in auditory health messages is recommended .

###24282871
OBJECTIVE	The aim of this randomized clinical trial was to evaluate the efficacy of a mouthrinse containing 1.4 % potassium oxalate ( Listerine Advanced Defence Sensitive ; LADS ) plus Colgate Cavity Protection Regular toothpaste , in reducing dentin sensitivity .
METHODS	This was an observer - and examiner-blinded , randomized , parallel-group , single-center , controlled , five-day clinical trial .
METHODS	Healthy adults were randomized ( 2:1:1 ) to LADS plus Colgate Cavity Protection Regular toothpaste , or to one of the two negative-control toothpastes alone : Crest Cavity Protection Regular or Colgate Cavity Protection Regular .
METHODS	The subjects carried out supervised and unsupervised brushing and rinsing twice a day .
METHODS	Dentin sensitivity was assessed at baseline and during treatment by Yeaple probe ( tactile pressure ; patient-reported discomfort by visual analogue scale [ VAS ] ) , as well as response to air blasts ( VAS ) .
RESULTS	All sensitivity assessments were similar at baseline in the 56 randomized subjects .
RESULTS	By the third day , the Yeaple probe sensitivity scores for subjects treated with Colgate toothpaste plus LADS improved significantly compared to Crest toothpaste alone ( p < 0.05 ) .
RESULTS	By the fifth day , the mean scores for subjects treated with Colgate toothpaste plus LADS were significantly improved compared with subjects treated with either toothpaste alone ( p < 0.05 ) .
RESULTS	The other sensitivity assessments showed that Colgate toothpaste plus LADS achieved statistically significant improvements compared with Colgate and/or Crest toothpaste alone from the third day .
CONCLUSIONS	The 1.4 % potassium oxalate mouthrinse ( LADS ) was associated with a reduction in dentinal sensitivity within a five-day period .
CONCLUSIONS	Statistically significant reductions in all sensitivity variables were achieved by Day 3 and even greater reductions in dentin sensitivity scores were observed after five days .

###25224097
BACKGROUND	The COPE-ICD ( Copenhagen Outpatient ProgrammE-implantable cardioverter defibrillator ) trial studied comprehensive cardiac rehabilitation for patients with ICDs .
BACKGROUND	The purpose of this paper was to explore : ( 1 ) gender differences in self-rated health and quality of life ( QoL ) at hospital discharge after ICD implantation , ( 2 ) gender differences in effect of cardiac rehabilitation , and ( 3 ) predictors of effect of cardiac rehabilitation .
METHODS	Patients with first-time ICD implantation were randomized to comprehensive cardiac rehabilitation versus usual care .
METHODS	Gender differences in self-rated health and QoL and effect of rehabilitation were tested using t-tests .
METHODS	Predictors of effect of rehabilitation were tested using logistic regression .
RESULTS	A total of 196 patients ( mean age 58 13 years ; 155 men , 41 women ) were included .
RESULTS	At hospital discharge , significant differences were found in physical component scale , mental component scale , social functioning , physical functioning , bodily pain , vitality , mental health , and QoL with men having higher scores .
RESULTS	Among men only , significant differences were found in VO2 ( rehabilitation : 20.9 mL/min/kg [ standard deviation ( SD ) 8.1 ] vs 23.4 mL/min/kg [ SD 9.5 ] and usual care : 22.1 mL/min/kg [ SD 8.1 ] vs 21.8 mL/min/kg [ SD 8.3 ] , P = 0.01 ) , total exercise time ( rehabilitation : 587.0 seconds [ SD 249.6 ] vs 650.7 seconds [ SD 279.8 ] and usual care : 613.8 seconds [ SD 264.7 ] vs 606.1 seconds [ SD 277.3 ] , P = 0.01 ) , and the mental component scale ( rehabilitation : 47.7 points [ SD 10.1 ] vs 54.8 points [ 7.1 ] and usual care : 48.1 points [ SD 10.9 ] vs 51.9 points [ SD 9.6 ] , P = 0.05 ) .
CONCLUSIONS	After ICD implantation , significant gender differences were found in physical health , mental health , and QoL .
CONCLUSIONS	Effects of rehabilitation were found among men only and gender predicted effect of rehabilitation on the mental component scale .

###24846429
OBJECTIVE	To compare the analgesic effects of intra-articularly administered saline ( 0.9 % NaCl ) solution , morphine , dexmedetomidine , and a morphine-dexmedetomidine combination in dogs undergoing stifle joint surgery for cranial cruciate ligament rupture .
METHODS	Randomized , controlled , clinical trial .
METHODS	44 dogs with cranial cruciate ligament rupture that underwent tibial tuberosity advancement ( TTA ) or tibial plateau leveling osteotomy ( TPLO ) .
METHODS	Dogs received intra-articular injections of saline solution ( 0.2 mL/kg [ 0.09 mL/lb ] ) , morphine ( 0.1 mg/kg [ 0.045 mg/lb ] ) , dexmedetomidine ( 2.5 g/kg [ 1.14 g/lb ] ) , or a combination of morphine ( 0.1 mg/kg ) and dexmedetomidine ( 2.5 g/kg ) .
METHODS	Intra-articular injections of the stifle joint were performed after completion of the corrective osteotomy procedure , just prior to skin closure .
METHODS	Signs of pain were assessed every 2 hours thereafter on the basis of mean behavioral and objective pain scores .
METHODS	Dogs with pain scores exceeding predetermined thresholds were given hydromorphone ( 0.05 mg/kg [ 0.023 mg/lb ] , SC ) as rescue analgesia .
RESULTS	Time to rescue analgesia did not significantly differ between dogs that underwent TTA versus TPLO .
RESULTS	No significant difference in time to rescue analgesia was found among dogs receiving intra-articular injections of dexmedetomidine ( median , 6 hours ; range , 2 to 10 hours ) , morphine ( median , 7 hours ; range , 4 to 10 hours ) , or saline solution ( median , 5 hours ; range , 4 to 10 hours ) .
RESULTS	However , time to rescue analgesia for dogs receiving intra-articular injection of the morphine-dexmedetomidine combination ( median , 10 hours ; range , 6 to 14 hours ) was significantly longer than the time to rescue analgesia for other treatment groups .
CONCLUSIONS	Intra-articular administration of the morphine-dexmedetomidine combination provided longer-lasting postoperative analgesia , compared with either morphine or dexmedetomidine alone , in dogs undergoing TTA or TPLO .

###25842727
METHODS	Ninety lower-limb stage II or worse TAO patients were randomly divided into three groups : group A ( 30 cases ) treated by intervention and oral administration of Chinese medicine ; group B ( 30 cases ) treated by intervention alone ; and group C ( 30 cases ) treated only with oral administration of Chinese medicine .
METHODS	Therapeutic effects were observed , including the cure rate ; the recurrence rate after one month , three months , six months , nine months , and one year ; the ankle brachial indexes ; the incidence of complications ; and the level of C-reactive protein and erythrocyte sedimentation rate .
RESULTS	Group A had significantly better clinically curative effects , related indexes , and outcomes during the long-term follow-up survey , than that of groups B and C.
CONCLUSIONS	Integrated treatment is more effective for treating lower-limb stage II or worse TAO .
OBJECTIVE	To observe if integrated treatment is better than other therapies for lower-limb stage II thromboangiitis obliterans ( TAO ) .

###25835443
BACKGROUND	Results of the SYMPLICITY HTN-3 ( Renal Denervation in Patients With Uncontrolled Hypertension ) trial confirmed the safety but not the efficacy of renal denervation for treatment-resistant hypertension at 6 months post procedure .
OBJECTIVE	This study sought to analyze the 12-month SYMPLICITY HTN-3 results for the original denervation group , the sham subjects who underwent denervation after the 6-month endpoint ( crossover group ) , and the sham subjects who did not undergo denervation after 6 months ( non-crossover group ) .
METHODS	Eligible subjects were randomized 2:1 to denervation or sham procedure .
METHODS	Subjects were unblinded to their treatment group after the 6-month primary endpoint was ascertained ; subjects in the sham group meeting eligibility requirements could undergo denervation .
METHODS	Change in blood pressure ( BP ) at 12 months post randomization ( 6 months for crossover subjects ) was analyzed .
RESULTS	The 12-month follow-up was available for 319 of 361 denervation subjects and 48 of 101 non-crossover subjects ; 6-month denervation follow-up was available for 93 of 101 crossover subjects .
RESULTS	In denervation subjects , the 12-month office systolic BP ( SBP ) change was greater than that observed at 6 months ( -15.5 24.1 mm Hg vs.-18 .9 25.4 mmHg , respectively ; p = 0.025 ) , but the 24-h SBP change was not significantly different at 12 months ( p = 0.229 ) .
RESULTS	Thenon-crossover group office SBP decreased by-32 .9 28.1 mmHg at 6 months , but this response regressed to-21 .4 19.9 mmHg ( p = 0.01 ) at 12 months , increasing to 11.5 29.8 mmHg .
CONCLUSIONS	These data support no further reduction in office or ambulatory BP after 1-year follow-up .
CONCLUSIONS	Loss of BPreduction in the non-crossover group may reflect decreased medication adherence or other related factors .
CONCLUSIONS	( Renal Denervation in Patients With Uncontrolled Hypertension [ SYMPLICITY HTN-3 ] ; NCT01418261 ) .

###25176317
BACKGROUND	Effective interventions to improve immunosuppressive medication adherence among adolescent and young adult kidney transplant recipients are desperately needed .
BACKGROUND	This paper describes the aims , design , and methods of the Teen Adherence in Kidney transplant , Effectiveness of Intervention Trial ( TAKE-IT ) study .
METHODS	TAKE-IT is a multicentre , prospective , open-label , parallel arm randomized controlled trial that aims to determine the effectiveness of a clinic-based intervention , including educational , organizational , and behavioural components , in improving immunosuppressive medication adherence among adolescent and young adult kidney transplant recipients .
METHODS	Individuals between 11 and 24 years of age who are at least 3 months post-transplant and followed in one of the eight participating pediatric kidney transplant programs , or their affiliated adult transplant programs are eligible to participate .
METHODS	All participating centers are tertiary care pediatric hospitals in Canada or the United States .
METHODS	Adherence is monitored using an electronic multi-dose pillbox for all participants during a 3-month run-in period , followed by a 12-month intervention interval .
METHODS	The primary outcome is ` taking adherence ' , defined as the proportion of prescribed doses of immunosuppressive medications that were taken , as measured using electronic monitoring.All participants meet with the study ` Coach ' at 3 month intervals .
METHODS	The intervention , administered by trained lay personnel , targets common adherence barriers .
METHODS	In addition to forming an Adherence Support Team , intervention participants identify personal barriers to adherence and use Action-focused problem-solving to address them , have their electronic adherence data fed back to them , and have the option to receive email , text message , or visual cue dose reminders .
METHODS	Participants in the control group meet with the coach but do not receive the other components of the intervention .
METHODS	The study aims to have 75 participants in each group complete the study .
CONCLUSIONS	Since recruitment began in Feb. 2012 , 198 adolescents have been approached to participate , of whom 130 have completed a baseline visit .
CONCLUSIONS	As of March 31 , 2014 , 125 had been randomized , and 86 , 68 , 61 , and 50 participants had completed 6-month , 9-month , 12-month , and 15-month visits respectively .
BACKGROUND	Clinicaltrials.gov registration NCT01356277 ( May 17 , 2011 ) .

###24530680
OBJECTIVE	The aim of the study was to investigate 4-year outcomes and predictors of repeat revascularization in patients treated with the Resolute zotarolimus-eluting stent ( R-ZES ) ( Medtronic , Minneapolis , Minnesota ) and XIENCE V everolimus-eluting stent ( EES ) ( Abbott Vascular , Abbott Park , Illinois ) in the RESOLUTE ( A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention ) All-Comers trial .
BACKGROUND	Data on long-term outcomes of new-generation drug-eluting stents are limited , and predictors of repeat revascularization due to restenosis and/or progression of disease are largely unknown .
METHODS	Patients were randomly assigned to treatment with the R-ZES ( n = 1,140 ) or the EES ( n = 1,152 ) .
METHODS	We assessed pre-specified safety and efficacy outcomes at 4 years including target lesion failure and stent thrombosis .
METHODS	Predictors of revascularization at 4 years were identified by Cox regression analysis .
RESULTS	At 4 years , the rates of target lesion failure ( 15.2 % vs. 14.6 % , p = 0.68 ) , cardiac death ( 5.4 % vs. 4.7 % , p = 0.44 ) , and target vessel myocardial infarction ( 5.3 % vs. 5.4 % , p = 1.00 ) , clinically-indicated target lesion revascularization ( TLR ) ( 7.0 % vs. 6.5 % , p = 0.62 ) , and definite/probable stent thrombosis ( 2.3 % vs. 1.6 % , p = 0.23 ) were similar with the R-ZES and EES .
RESULTS	Independent predictors of TLR were age , insulin-treated diabetes , SYNTAX ( Synergy between PCI with Taxus and Cardiac Surgery ) score , treatment of saphenous vein grafts , ostial lesions , and in-stent restenosis .
RESULTS	Independent predictors of any revascularization were age , diabetes , previous percutaneous coronary intervention , absence of ST-segment elevation myocardial infarction , smaller reference vessel diameter , SYNTAX score , and treatment of left anterior descending , right coronary artery , saphenous vein grafts , ostial lesions , or in-stent restenosis .
CONCLUSIONS	R-ZES and EES demonstrated similar safety and efficacy throughout 4 years .
CONCLUSIONS	TLR represented less than one-half of all repeat revascularization procedures .
CONCLUSIONS	Patient - and lesion-related factors predicting the risk of TLR and any revascularization showed considerable overlap .
CONCLUSIONS	( A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention [ RESOLUTE-AC ] ; NCT00617084 ) .

###24643911
BACKGROUND	This was a randomized , open-label , three-way crossover study to assess the effects of AST-120 ( an orally administered spherical carbon adsorbent acting in the gastrointestinal tract without systemic circulation ) on the single-dose pharmacokinetics of metoprolol in an extended-release formulation ( metoprolol ER ) in healthy volunteers .
METHODS	A total of 34 subjects were singly administered metoprolol ER alone ( A ) , and metoprolol ER in combination with AST-120 simultaneously ( B ) and 1 h later ( C ) .
RESULTS	The total exposure was more significantly reduced in both treatments B and C than that in treatment A ; the geometric mean ratios of area under the curve extrapolated to infinity ( AUC0 - ) for B/A and C/A were reduced by approximately 30 % in both treatments B and C. Maximum observed plasma concentration ( Cmax ) of metoprolol in treatment B significantly decreased , whereas Cmax in treatment C was slightly decreased .
RESULTS	AST-120 treatment was unlikely to affect apparent first-order terminal elimination half-life ( T1/2 ) of metoprolol significantly .
RESULTS	Reduction in heart rate and blood pressure readings were similar across the treatment periods .
RESULTS	Coadministration of AST-120 and metoprolol ER was safe and was well tolerated .
CONCLUSIONS	Because AST-120 reduced gastrointestinal absorption of metoprolol ER , careful monitoring of heart rate and blood pressure is recommended in coadministration of AST-120 with metoprolol ER .

###25275701
BACKGROUND	The purpose of this study was to compare the tolerance , efficacy , and safety of endobronchial ultrasound-guided transbronchial needle aspiration ( EBUS-TBNA ) with transesophageal endoscopic ultrasound-guided fine-needle aspiration ( EUS-FNA ) with an endobronchial ultrasound scope for the first pathologic diagnosis of lesions accessible by both procedures .
METHODS	Patients who had lesions accessible by both EBUS-TBNA and EUS-FNA were enrolled and were randomized to undergo either procedure .
METHODS	Patients quantified tolerance , and operators charted the quality of examination using a 100-mm visual analog scale ( VAS ) .
RESULTS	A specific diagnosis was made in 50 of 55 patients ( 91 % ) in the EBUS-TBNA group and in 48 of 55 patients ( 87 % ) in the EUS-FNA group ( P = .76 ) .
RESULTS	Compared with EBUS-TBNA , EUS-FNA was associated with a shorter duration of procedure ( median , 15.3 min vs 11.3 min ; P < .001 ) , lower doses of IV midazolam ( mean , 4.4 mg vs 4 mg ; P = .02 ) and intraairway lidocaine ( mean , 303 mg vs 189 mg ; P < .001 ) , less frequent oxygen desaturations ( 23 of 55 vs two of 55 , P < .001 ) , and higher operator satisfaction ( P < .001 ) .
RESULTS	There was no significant difference in patient tolerance according to the patients ' VAS .
RESULTS	Lymph node infection occurred in one patient in the EBUS-TBNA group and in two patients in the EUS-FNA group .
CONCLUSIONS	Both EBUS-TBNA and EUS-FNA provide high accuracy with good tolerance , although the occurrence of infectious complications should be monitored carefully .
CONCLUSIONS	EUS-FNA has the advantage of comparable tolerance with fewer doses of anesthetics and sedatives , a shorter procedure time , and fewer oxygen desaturations during the procedure .
BACKGROUND	UMIN Clinical Trials Registry ; No. : UMIN000005757 ; URL : http://www.umin.ac.jp/ctr/ .

###24720924
OBJECTIVE	The objective of this study was to determine the impact of nonfatal cardiovascular ( CV ) events on changes in health-related quality of life ( HRQL ) .
BACKGROUND	There is limited understanding of the impact of nonfatal CV events on long-term changes in HRQL in survivors ofmyocardial infarction ( MI ) .
METHODS	The VALIANT ( Valsartan In Acute Myocardial Infarction ) trial enrolled 14,703 patients post-MI complicated by Killip class II or higher ( scale measuring heart failure severity post-MI ranging from class I to IV ) and/or reduced ejection fraction .
METHODS	The HRQL substudy included 2,556 ( 17.4 % ) patients who completed the EQ-5D with 5 questions , with responses mapped to utility weight on a scale of 0 to 1 and a visual analog scale ( VAS ) ranging from 0 ( worst ) to 100 ( best ) imaginable health state .
METHODS	EQ-5D was administered at baseline and 6 , 12 , 20 , and 24 months .
METHODS	The trajectory of EQ-5D scores was developed by using linear mixed effects regression models with calculation of deviation from this trajectory after nonfatal CV events .
METHODS	Patients who died before the next EQ-5D assessment were excluded .
RESULTS	Over a 2-year period , 597 patients experienced a nonfatal CV event and survived to have another EQ-5D assessment .
RESULTS	Their baseline EQ-5D scores were lower than patients without a subsequent nonfatal CV event ( VAS 61.0 19 vs 68.2 18 [ p < 0.001 ] and US-based utility score 0.76 0.22 vs 0.83 0.17 [ p < 0.001 ] ) .
RESULTS	These patients with CVevents experienced a trajectory-adjusted 6.6 point decrease ( p < 0.001 ) in VAS scores and a 0.07 decrease ( p < 0.001 ) in utility score after the nonfatal CV event .
CONCLUSIONS	MI survivors suffering a CV event experienced significantly worse HRQL than their previous trajectory , suggesting that generic instruments can be responsive to nonfatal events .
CONCLUSIONS	Reduction in nonfatal CV events may affect longitudinal changes in HRQL .

###25053129
BACKGROUND	Vaccination with dendritic cells ( DC ) loaded with tumor antigens elicits tumor-specific immune responses capable of killing cancer cells without inducing meaningful side-effects .
BACKGROUND	Patients with advanced melanoma enrolled onto our phase II clinical studies have been treated with autologous DC loaded with autologous tumor lysate/homogenate matured with a cytokine cocktail , showing a clinical benefit ( PR+SD ) in 55.5 % of evaluable cases to date .
BACKGROUND	The beneficial effects of the vaccine were mainly restricted to patients who developed vaccine-specific immune response after treatment .
BACKGROUND	However , immunological responses were only induced in about two-thirds of patients , and treatments aimed at improving immunological responsiveness to the vaccine are needed .
METHODS	This is a phase II , `` proof-of-principle '' , randomized , open-label trial of vaccination with autologous DC loaded with tumor lysate or homogenate in metastatic melanoma patients combined with immunomodulating RT and/or preleukapheresis IFN - .
METHODS	All patients will receive four bi-weekly doses of the vaccine during the induction phase and monthly doses thereafter for up to a maximum of 14 vaccinations or until confirmed progression .
METHODS	Patients will be randomized to receive : ( 1 . )
METHODS	three daily doses of 8Gy up to 12Gy radiotherapy delivered to one non-index metastatic field between vaccine doses 1 and 2 and , optionally , between doses 7 and 8 , using IMRT-IMAT techniques ; ( 2 . )
METHODS	daily 3 MU subcutaneous IFN - for 7days before leukapheresis ; ( 3 . )
METHODS	both 1 and 2 ; ( 4 . )
METHODS	neither 1 nor 2 .
METHODS	At least six patients eligible for treatment will be enrolled per arm .
METHODS	Daily 3 MU IL-2 will be administered subcutaneously for 5days starting from the second day after each vaccine dose .
METHODS	Serial DTH testing and blood sampling to evaluate treatment-induced immune response will be performed .
METHODS	Objective response will be evaluated according to immune-related response criteria ( irRC ) .
CONCLUSIONS	Based upon the emerging role of radiotherapy as an immunologic modifier , we designed a randomized phase II trial adding radiotherapy and/or preleukapheresis IFN - to our DC vaccine in metastatic melanoma patients .
CONCLUSIONS	Our aim was to find the best combination of complementary interventions to enhance anti-tumor response induced by DC vaccination , which could ultimately lead to better survival and milder toxicity .

###24992751
OBJECTIVE	To compare two therapeutic methods : electroacupuncture + massage + blocking therapy , and blocking therapy alone in the treatment of external humeral epicondylitis .
METHODS	Eighty-six patients were randomized into two groups with 43 in each .
METHODS	The treatment group received electroacupuncture + massage + blocking therapy , while the control group received blocking therapy only .
METHODS	A course of electroacupuncture treatment included therapy once a day for 10 days .
METHODS	There were 10 treatments in a massage course and massage was given once a day , with a 1-week interval given before the next course .
METHODS	A course of blocking treatment included therapy once a week , for two total treatments , and generally no more than three times .
METHODS	The therapeutic effects were evaluated with the visual analog scale ( VAS ) , grip strength index ( GSI ) score , and Mayo elbow performance score ( MEPS ) before treatment and at 0 , 6 , 12 , and 24 months after treatment to observe the total effective rate .
RESULTS	In the treatment and control groups before treatment and at 0 , 6 , 12 , and 24 months after treatment , the VAS scores were : 6.5 + / - 1.9 and 6.4 + / - 1.6 ; 4.6 + / - 1.3 and 4.6 + / - 1.7 ; 4.8 + / - 1.3 and 4.8 + / - 1.2 ; 4.6 + / - 1.2 and 6.6 + / - 1.6 ; and 6.5 + / - 1.6 and 6.5 + / - 1.3 , respectively .
RESULTS	The GSI scores were 63 + / - 8 and 63 + / - 8 ; 84 + / - 6 and 82 + / - 7 ; 82 + / - 7 and 82 + / - 6 ; 84 + / - 6 and 62 + / - 8 ; and 64 + / - 6 and 64 + / - 7 , respectively .
RESULTS	The MEPS of both groups were 65 + / - 7 and 66 + / - 8 ; 85 + / - 6 and 84 + / - 7 ; 84 + / - 5 and 84 + / - 7 ; 80 + / - 7 and 66 + / - 6 ; and 65 + / - 6 and 65 + / -7 , respectively .
RESULTS	The total effective rates of the treatment and control groups at 0 , 6 , 12 , and 24 months after treatment were 87.5 % and 85.0 % ; 85.0 % and 82.5 % ; 80.0 % and 12.5 % ; and 2.5 % and 5.0 % , respectively .
RESULTS	Compared with the treatment group , the control group had greater joint function , better therapeutic effect , and lower pain intensity ( P < 0.01 ) , indicating a high recurrence rate in the 12th month after treatment .
RESULTS	There were no differences in VAS , GSI , or MEPS at 0 , 6 , and 24 months after treatment ( P > 0.05 ) between the two groups .
CONCLUSIONS	We found that both methods were effective for external humeral epicondylitis .
CONCLUSIONS	After 6 months of treatment , the effects were good in both groups .
CONCLUSIONS	However , in the 12th month , the control group had a relatively severe relapse .
CONCLUSIONS	After 24 months , both groups relapsed .
CONCLUSIONS	The effect of electroacupuncture , massage , and blocking therapy used in combination lasted longer , delaying the recurrence of the disease .

###24518149
BACKGROUND	The change in volume of anatomic structures is as a sensitive indicator of Alzheimer disease ( AD ) progression .
BACKGROUND	Although several methods are available to measure brain volumes , improvements in speed and automation are required .
BACKGROUND	Our objective was to develop a fully automated , fast , and reliable approach to measure change in medial temporal lobe ( MTL ) volume , including primarily hippocampus .
METHODS	The MTL volume defined in an atlas image was propagated onto each baseline image and a level set algorithm was applied to refine the shape and smooth the boundary .
METHODS	The MTL of the baseline image was then mapped onto the corresponding follow-up image to measure volume change ( MTL ) .
METHODS	Baseline and 24 months 3D T1-weighted images from the Alzheimer Disease Neuroimaging Initiative ( ADNI ) were randomly selected for 50 normal elderly controls ( NECs ) , 50 subjects with mild cognitive impairment ( MCI ) and 50 subjects with AD to test the algorithm .
METHODS	The method was compared to the FreeSurfer segmentation tools .
RESULTS	The average MTL ( meanSEM ) was 6835mm ( 3 ) in NEC , 18738mm ( 3 ) in MCI and 30034mm ( 3 ) in the AD group and was significantly different ( p < 0.0001 ) between all three groups .
RESULTS	The MTL was correlated with cognitive decline .
CONCLUSIONS	Results for the FreeSurfer software were similar but did not detect significant differences between the MCI and AD groups .
CONCLUSIONS	This novel segmentation approach is fully automated and provides a robust marker of brain atrophy that shows different rates of atrophy over 2 years between NEC , MCI , and AD groups .

###24905296
BACKGROUND	Although spironolactone has been shown to decrease morbidity and mortality in patients with heart failure and reduced left ventricular ejection fraction , its role in patients with heart failure and preserved left ventricular ejection fraction ( HFpEF ) is not well defined .
BACKGROUND	In this study we investigated the mechanisms involved when elderly women with HFpEF are treated with spironolactone .
RESULTS	Forty-eight women with HFpEF were enrolled in a randomized placebo-controlled trial and were assigned to 25 mg spironolactone daily ( n = 24 ) or placebo ( n = 24 ) for 6 months .
RESULTS	Six-minute walk distance , clinical composite score , Doppler echocardiography , and biomarkers were determined at baseline and after 3 and 6 months of therapy .
RESULTS	Six months of spironolactone treatment stabilized clinical symptoms , as demonstrated by significant worsening of the clinical composite score in the placebo group ( P = .02 ) .
RESULTS	In addition , spironolactone treatment improved diastolic function by significantly increasing early diastolic tissue Doppler velocity of the lateral mitral annulus ( lateral e ' ; P = .003 ) and significantly reducing the mitral peak E velocity to lateral e ' ratio ( lateral E/e ' ; P = .0001 ) .
RESULTS	Finally , spironolactone favorably affected remodeling through a reduction in myocardial fibrosis measured by a reduction in type III procollagen levels ( P = .035 ) .
RESULTS	Six-minute walk distance did not significantly improve with spironolactone treatment compared with placebo .
CONCLUSIONS	Spironolactone stabilizes functional capacity and symptoms and improves diastolic function , possibly through its ability to suppress type III procollagen synthesis .

###25063274
OBJECTIVE	Orexin A ( OXA ) modulates food intake , energy expenditure , and lipid and glucose metabolism .
OBJECTIVE	OXA regulates the secretion of insulin and glucagon , while glucose regulates OXA release .
OBJECTIVE	Here , we evaluate the role of glucagon in regulating OXA release both in vivo and in vitro .
METHODS	In a double-blind crossover study , healthy volunteers and type 1 diabetic patients received either intramuscular glucagon or placebo .
METHODS	Patients newly diagnosed with type 2 diabetes underwent hyperinsulinaemic-euglycaemic clamp experiments , and insulin-hypoglycaemia tests were performed on healthy volunteers .
METHODS	The primary endpoint was a change in OXA levels after intramuscular glucagon or placebo administration in healthy participants and patients with type 1 diabetes .
METHODS	Secondary endpoints included changes in OXA in healthy participants during insulin tolerance tests and in patients with type 2 diabetes under hyperinsulinaemic-euglycaemic conditions .
METHODS	Participants and staff conducting examinations and taking measurements were blinded to group assignment .
METHODS	OXA secretion in response to glucagon treatment was assessed in healthy and obese mice , the streptozotocin-induced mouse model of type 1 diabetes , and isolated rat pancreatic islets .
RESULTS	Plasma OXA levels declined in lean volunteers and in type 1 diabetic patients injected with glucagon .
RESULTS	OXA levels increased during hyperinsulinaemic hypoglycaemia testing in healthy volunteers and during hyperinsulinaemic euglycaemic conditions in type 2 diabetic patients .
RESULTS	Plasma OXA concentrations in healthy lean and obese mice and in a mouse model of type 1 diabetes were lower after glucagon treatment , compared with vehicle control .
RESULTS	Glucagon decreased OXA secretion from isolated rat pancreatic islets at both low and high glucose levels .
RESULTS	OXA secretion declined in pancreatic islets exposed to diazoxide at high and low glucose levels , and after exposure to an anti-insulin antibody .
RESULTS	Glucagon further reduced OXA secretion in islets pretreated with diazoxide or an anti-insulin antibody .
CONCLUSIONS	Glucagon inhibits OXA secretion in humans and animals , irrespective of changes in glucose or insulin levels .
CONCLUSIONS	Through modifying OXA secretion , glucagon may influence energy expenditure , body weight , food intake and glucose metabolism .

###24848492
OBJECTIVE	This study aimed to determine the interaction between a high-fructose diet and PA levels on postprandial lipidemia and inflammation in normal-weight , recreationally active individuals .
METHODS	Twenty-two men and women ( age , 21.2 0.6 yr ; body mass index , 22.5 0.6 kg m ( -2 ) ) consumed an additional 75 g of fructose for 14 d on two separate occasions : high physical activity ( PA ) ( approximately 12,500 steps per day ) ( FR + active ) and low PA ( approximately 4500 steps per day ) ( FR + inactive ) .
METHODS	A fructose-rich test meal was given before and at the end of each intervention .
METHODS	Blood was sampled at baseline and for 6 h after the meal for triglycerides ( TG ) , VLDL , total cholesterol , glucose , insulin , tumor necrosis factor - , interleukin 6 , and C-reactive protein .
RESULTS	Log-transformed TG area under the curve ( AUC ) significantly increased from before ( 10.1 0.1 mg dL ( -1 ) min for 6 h ) to after ( 10.3 0.08 mg dL ( -1 ) min for 6 h , P = 0.04 ) the FR + inactive intervention , with an 88 % increase in peak TG ( P = 0.009 ) and an 84 % increase in peak VLDL ( P = 0.002 ) .
RESULTS	Peak interleukin 6 also increased by 116 % after the FR + inactive intervention ( P = 0.009 ) .
RESULTS	Insulin total AUC significantly decreased after FR + active intervention ( P = 0.04 ) , with no change in AUC after the FR + inactive intervention .
RESULTS	No changes were observed in glucose , tumor necrosis factor - , and C-reactive protein concentrations ( P > 0.05 ) .
CONCLUSIONS	Low PA during a period of high fructose intake augments fructose-induced postprandial lipidemia and inflammation , whereas high PA minimizes these fructose-induced metabolic disturbances .
CONCLUSIONS	Even within a young healthy population , maintenance of high PA ( > 12,500 steps per day ) decreases susceptibility to cardiovascular risk factors associated with elevated fructose consumption .

###25171195
BACKGROUND	Apnea of prematurity is a common condition that is usually treated with caffeine , an adenosine receptor blocker that has powerful influences on the central nervous system .
BACKGROUND	However , little is known about the long-term effects of caffeine on sleep in the developing brain .
OBJECTIVE	We hypothesized that neonatal caffeine use resulted in long-term abnormalities in sleep architecture and breathing during sleep .
METHODS	A total of 201 ex-preterm children aged 5-12 years who participated as neonates in a double-blind , randomized , controlled clinical trial of caffeine versus placebo underwent actigraphy , polysomnography , and parental sleep questionnaires .
METHODS	Coprimary outcomes were total sleep time on actigraphy and apnea-hypopnea index on polysomnography .
RESULTS	There were no significant differences in primary outcomes between the caffeine group and the placebo ( adjusted mean difference of -6.7 [ 95 % confidence interval ( CI ) = -15.3 to 2.0 min ] ; P = 0.13 for actigraphic total sleep time ; and adjusted rate ratio [ caffeine/placebo ] for apnea-hypopnea index of 0.89 [ 95 % CI = 0.55-1 .43 ] ; P = 0.63 ) .
RESULTS	Polysomnographic total recording time and total sleep time were longer in the caffeine group , but there was no difference in sleep efficiency between groups .
RESULTS	The percentage of children with obstructive sleep apnea ( 8.2 % of caffeine group versus 11.0 % of placebo ; P = 0.22 ) or elevated periodic limb movements of sleep ( 17.5 % in caffeine group versus 11 % in placebo group ) was high , but did not differ significantly between groups .
CONCLUSIONS	Therapeutic neonatal caffeine administration has no long-term effects on sleep duration or sleep apnea during childhood .
CONCLUSIONS	Ex-preterm infants , regardless of caffeine status , are at risk for obstructive sleep apnea and periodic limb movements in later childhood .

###24355050
OBJECTIVE	To determine whether increased antioxidant intake in women is associated with shorter time to pregnancy ( TTP ) among a cohort of couples being treated for unexplained infertility .
METHODS	Secondary data analysis of a randomized controlled trial .
METHODS	Academic medical center associated with a private infertility center .
METHODS	Females with unexplained infertility .
METHODS	None .
METHODS	The time it took to establish a pregnancy that led to a live birth .
RESULTS	Mean nutrient intake exceeded the estimated average requirement ( EAR ) for vitamins C and E. No differences in mean intake of any of the antioxidants were noted between women who delivered a live-born infant during the study period vs. those who did not .
RESULTS	In multivariable models , intake of - carotene from dietary supplements was associated with shorter TTP among women with body mass index ( BMI ) 25 kg/m ( 2 ) ( hazard ratio [ HR ] 1.29 , 95 % confidence interval [ CI ] 1.09-1 .53 ) and women < 35 y ( HR 1.19 , 95 % CI 1.01-1 .41 ) .
RESULTS	Intake of vitamin C from dietary supplements was associated with shorter TTP among women with BMI < 25 kg/m ( 2 ) ( HR 1.09 , 95 % CI 1.03-1 .15 ) and women < 35 y ( HR 1.10 , 95 % CI 1.02-1 .18 ) .
RESULTS	Intake of vitamin E from dietary supplements among women 35 y also was associated with shorter TTP ( HR 1.07 , 95 % CI 1.01-1 .13 ) .
CONCLUSIONS	Shorter TTP was observed among women with BMI < 25 kg/m ( 2 ) with increasing vitamin C , women with BMI 25 kg/m ( 2 ) with increasing - carotene , women < 35 y with increasing - carotene and vitamin C , and women 35 y with increasing vitamin E.
BACKGROUND	NCT00260091 .

###24781074
OBJECTIVE	Bivalirudin ( Angiox , The Medicine 's Company , Parsippany , NJ ) , a synthetic direct thrombin inhibitor , when compared with standard antithrombotic therapy ( including unfractionated heparin [ UFH ] alone or plus a glycoprotein IIb/IIIa inhibitor ) determines a significant decrease of major and minor bleeding and similar protection against ischemic events both in elective and in urgent percutaneous coronary intervention ( PCI ) .
OBJECTIVE	There is a lack of prospective clinical trial assessing the safety and the efficacy of bivalirudin compared with UFH alone in the subset of biomarker negative patients at high risk of bleeding undergoing to elective PCI through the femoral approach .
METHODS	This is a single-center , investigator-driven , randomized , double-blind , controlled trial ( www.clinicaltrial.gov registration : NCT01465503 ) .
METHODS	Consecutive patients at high bleeding risk ( score 10 according to Nikolsky et al. ) undergoing elective PCI through the femoral approach will be screened for eligibility .
METHODS	Included patients will be randomized ( ratio 1.1 ) to bivalirudin ( Bivalirudin group ) and UFH ( UFH group ) .
METHODS	The primary endpoint will be the rate of major bleeding ( REPLACE 2 criteria ) .
METHODS	We expect a major bleeding rate 5 % in the UFH group versus a 3 % event rate in the Bivalirudin group .
METHODS	Aiming for a 0.05 alpha and 0.80 power , a total of 662 patients will be needed .
METHODS	This number will be increased by about 25 % ( leading to a total of 830 patients ) because of uncertainty about expected endpoint rates .
CONCLUSIONS	The present trial will give important information on what is the best anticoagulation regimen when performing PCI through the femoral approach in patients at high risk for bleeding .

###25436819
BACKGROUND	Sexual and reproductive health ( SRH ) services for HIV-positive women and men often neglect their fertility desires .
BACKGROUND	We examined factors associated with pregnancy intent among recently diagnosed HIV-positive women ( N = 106 ) and men ( N = 91 ) who reported inconsistent condom use and were enrolled in an SRH intervention conducted in public sector HIV care clinics in Cape Town .
METHODS	Participants were recruited when receiving their first CD4 results at the clinic .
METHODS	All reported unprotected sex in the previous 3 months .
METHODS	Logistic regression identified predictors of pregnancy intent for the total sample and by gender .
RESULTS	About three fifths of men and one fifth of women reported intent to conceive in the next 6 months .
RESULTS	In the full-sample multiple regression analysis , men [ adjusted odds ratio ( AOR = 6.62 ) ] and those whose main partner shared intent to conceive ( AOR = 3.80 ) had significantly higher odds of pregnancy intent ; those with more years of education ( AOR = 0.81 ) and more biological children ( AOR = 0.62 ) had lower odds of intending pregnancy .
RESULTS	In gender-specific analyses , partner sharing pregnancy intent was positively associated with intent among both men ( AOR = 3.53 ) and women ( AOR = 13.24 ) .
RESULTS	Among men , odds were lower among those having more biological children ( AOR = 0.71 ) and those unemployed ( AOR = 0.30 ) .
RESULTS	Among women , relying on hormonal contraception was negatively associated with intent ( AOR = 0.08 ) , and main partner knowing her HIV status ( AOR = 5.80 ) was positively associated with intent to conceive .
CONCLUSIONS	Findings underscore the importance of providing integrated SRH services , and we discuss implications for clinical practice and care .

###26158927
OBJECTIVE	To compare posterior capsule opacification ( PCO ) of a hydrophobic acrylic heparin surface modified intraocular lens ( HSM-IOL ) and an uncoated IOL ( UC-IOL ) 1 year after implantation .
METHODS	One hundred two eyes of 51 patients underwent routine phacoemulsification with randomized implantation of a HSM-IOL in one eye ( the HSM-IOL group ) and a UC-IOL in the fellow eye ( the UC-IOL group ) .
METHODS	Morphologic PCO evaluation was performed comparing digital photographs in retroillumination using the Evaluation of Posterior Capsule Opacification ( EPCO ) system , grading the density of the opacification from 0 to 4 ( 0 = none , 1 = minimal , 2 = mild , 3 = moderate , and 4 = severe ) .
METHODS	Distance visual acuities , subjective manifest refraction , pupil size , straylight measurements , flare in the anterior chamber using a laser flare meter , and contrast sensitivity were also evaluated .
RESULTS	The mean total EPCO score was slightly higher in the HSM-IOL group ( 0.50 0.45 ) compared to the UC-IOL group ( 0.45 0.46 ) , but did not reach statistical significance .
RESULTS	No statistically significant differences were found in the other main outcome parameters ( straylight measurement , distance visual acuities , flare in the anterior chamber , and mesopic and photopic contrast sensitivity ) when comparing both IOLs .
CONCLUSIONS	Although the HSM-IOL showed decreased flare 1 day postoperatively , no statistically significant differences regarding PCO were found 1 year postoperatively .

###24255945
BACKGROUND	Unsupervised segmentation of multi-spectral images plays an important role in annotating infrared microscopic images and is an essential step in label-free spectral histopathology .
BACKGROUND	In this context , diverse clustering approaches have been utilized and evaluated in order to achieve segmentations of Fourier Transform Infrared ( FT-IR ) microscopic images that agree with histopathological characterization .
RESULTS	We introduce so-called interactive similarity maps as an alternative annotation strategy for annotating infrared microscopic images .
RESULTS	We demonstrate that segmentations obtained from interactive similarity maps lead to similarly accurate segmentations as segmentations obtained from conventionally used hierarchical clustering approaches .
RESULTS	In order to perform this comparison on quantitative grounds , we provide a scheme that allows to identify non-horizontal cuts in dendrograms .
RESULTS	This yields a validation scheme for hierarchical clustering approaches commonly used in infrared microscopy .
CONCLUSIONS	We demonstrate that interactive similarity maps may identify more accurate segmentations than hierarchical clustering based approaches , and thus are a viable and due to their interactive nature attractive alternative to hierarchical clustering .
CONCLUSIONS	Our validation scheme furthermore shows that performance of hierarchical two-means is comparable to the traditionally used Ward 's clustering .
CONCLUSIONS	As the former is much more efficient in time and memory , our results suggest another less resource demanding alternative for annotating large spectral images .

###25351455
OBJECTIVE	Breast cancer survivors who make preference-sensitive decisions about postmastectomy breast reconstruction often have large gaps in knowledge and undergo procedures that are misaligned with their treatment goals .
OBJECTIVE	We evaluated the feasibility and effect of a pre-consultation educational group intervention on the decision-making process for breast reconstruction .
METHODS	We conducted a pilot randomized controlled trial ( RCT ) where participants were randomly assigned to the intervention with routine education or routine education alone .
METHODS	The outcomes evaluated were decisional conflict , decision self-efficacy , satisfaction with information , perceived involvement in care , and uptake of reconstruction following surgical consultation .
METHODS	Trial feasibility and acceptability were evaluated , and effect sizes were calculated to determine the primary outcome for the full-scale RCT .
RESULTS	Of the 41 patients enrolled , recruitment rate was 72 % , treatment fidelity was 98 % , and retention rate was 95 % .
RESULTS	The Cohen 's d effect size in reduction of decisional conflict was moderate to high for the intervention group compared to routine education ( 0.69 , 95 % CI = 0.02-1 .42 ) , while the effect sizes of increase in decision self-efficacy ( 0.05 , 95 % CI = -0.60 -0.71 ) and satisfaction with information ( 0.11 , 95 % CI = -0.53 -0.76 ) were small .
RESULTS	A higher proportion of patients receiving routine education signed informed consent to undergo breast reconstruction ( 14/20 or 70 % ) compared to the intervention group ( 8/21 or 38 % ) P = 0.06 .
CONCLUSIONS	A pre-consultation educational group intervention improves patients ' shared decision-making quality compared to routine preoperative patient education .
CONCLUSIONS	A full-scale definitive RCT is warranted based on high feasibility outcomes , and the primary outcome for the main trial will be decisional conflict .

###26027627
BACKGROUND	The incremental prognostic value of admission measurements of biomarkers beyond clinical characteristics and extent of coronary artery disease ( CAD ) in patients treated with primary percutaneous coronary intervention ( PPCI ) for ST-elevation myocardial infarction ( STEMI ) is unclear .
METHODS	Centrally analyzed plasma for biomarker measurements was available in 5,385 of the STEMI patients treated with PPCI in the PLATO trial .
METHODS	Extent of CAD was graded by operators in association with PPCI .
METHODS	We evaluated the prognostic value of high-sensitivity cardiac troponin T , N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) , and growth differentiation factor 15 ( GDF-15 ) beyond clinical characteristics and extent of CAD using Cox proportional hazards analyses , C-index , and net reclassification improvement ( NRI ) .
METHODS	Outcomes were cardiovascular death ( CVD ) and spontaneous myocardial infarction ( MI ) .
RESULTS	Angiographic data on extent of CAD improved the prediction of CVD compared to clinical risk factors alone , increasing the C-index from 0.760 to 0.778 , total NRI of 0.31 .
RESULTS	Biomarker information provided additional prognostic value for CVD beyond clinical risk factors and extent of CAD , C-indices ranging from 0.792 to 0.795 for all biomarkers , but with a higher NRI for NT-proBNP .
RESULTS	Extent of CAD and high-sensitivity cardiac troponin T were not associated with spontaneous MI .
RESULTS	The prediction of spontaneous MI beyond clinical characteristics and extent of CAD ( C-index 0.647 ) was improved by both NT-proBNP ( C-index 0.663 , NRI 0.22 ) and GDF-15 ( C-index 0.652 , NRI 0.05 ) .
CONCLUSIONS	Biomarker measurement on admission is feasible and provides incremental risk stratification in patients with STEMI treated with PPCI , with NT-proBNP and GDF-15 being most valuable due to the association with both CVD and spontaneous MI .

###25053385
OBJECTIVE	Use of the patient 's body surface area ( mg m ( -2 ) ) as a basis for dosing does not take individual variation in metabolic capacity and rate of clearance into account .
OBJECTIVE	Here , we evaluated a novel approach for individual monitoring of short-lived cytotoxic agents formed from cytostatic drugs such as cyclophosphamide ( CP ) .
METHODS	The accumulated blood dose of the cytotoxic active agent phosphoramide mustard ( PAM ) formed from CP was measured as a reaction product with hemoglobin ( Hb adduct ) .
METHODS	This adduct , N - [ 2 - ( 2-oxazolidonyl ) ethyl ] - valyl Hb ( OzVal-Hb ) , was detached from Hb with the adduct FIRE procedure , and the formed analyte was quantified using LC-MS/MS .
METHODS	This dose biomarker for PAM and the analytical procedure was evaluated in accordance with the guidelines on bioanalytical method validation formulated by the European Medicine Agency .
METHODS	The evaluated method was applied to quantify blood dose levels of PAM in female breast cancer patients ( n = 12 ) before and after three cycles of polychemotherapy regimes containing CP .
RESULTS	OzVal-Hb , a specific and stable biomarker , could be measured with great sensitivity ( lower limit of quantification = 33 pmol g ( -1 ) Hb ) , high accuracy ( within 20 % ) and good repeatability ( CV < 20 % ) .
RESULTS	The inter-individual variability in the blood level of this adduct in women with breast cancer ( n = 12 ) who received three doses of CP in combination with one or two other cytostatic drugs was 250 % following the first dose and approximately 150 % after each subsequent dose .
CONCLUSIONS	Measurement of the biomarker OzVal-Hb can be used to quantify the short-lived cytotoxic agent PAM in a single blood sample drawn several days after therapy .
CONCLUSIONS	This procedure may aid in individualizing doses of CP , thereby improving efficacy while both reducing the risk of and increasing the predictability of side-effects .

###24667430
OBJECTIVE	The objective of this study was to evaluate the effect of platelet-rich plasma ( PRP ) , platelet-rich fibrin ( PRF ) , and concentrated growth factor ( CGF ) on bone healing .
METHODS	Twelve rabbits were included in this randomized , blinded , prospective study .
METHODS	15-mm10-mm-sized defects were created in the parietal bone , filled with PRP , PRF , CGF , and void .
METHODS	The bone mineral density and bone volume were analyzed with microscopic computed tomography ( micro-CT ) and histomorphometrics at the 6th and 12th week .
RESULTS	In micro-CT analysis , bone mineral density and bone volume were greater in the experimental group than in controls at both 6th and 12th week , but not among the experimental groups .
RESULTS	Similarly , histomorphometric examination revealed that more bone formation was seen in the experimental group .
CONCLUSIONS	The addition of PRP , PRF , and CGF had significantly increased bone formation at the 6th week .
CONCLUSIONS	The effect of PRP , PRF , and CGF was similar and may be useful in the future to increase the success rate of bone grafting .

###25906565
OBJECTIVE	To evaluate the short-term efficacy and long-term preventive effect on recurrence in prevention and treatment of children allergic rhinitis treated with the multiple therapy at Dazhui ( GV 14 ) as the main acupoint and acupoint plaster therapy .
METHODS	One hundred and twenty cases of children allergic rhinitis were randomized into a triple-strong stimulation therapy group and an acupoint plaster therapy group , 60 cases in each one .
METHODS	In the triple-strong stimulation therapy group , Dazhui ( GV 14 ) was the main acupoint , combined with one of Feishu ( BL 13 ) , Zhiyang ( GV 9 ) and Shenshu ( BL 23 ) accordingly .
METHODS	The heavy needling technique was adopted with the three-edged needle , followed by heavy cupping and heavy moxibustion .
METHODS	The treatment was given once every 3 days , continuously for 10 times .
METHODS	In the acupoint plaster therapy group , the acupoints selected were same as the triple-strong stimulation therapy group .
METHODS	The self-prepared Chinese herbal plaster was used , 4 h to 8 h each one time , once every 3 days , continuously for 10 times .
METHODS	The changes in the symptom and physical sign scores were observed before treatment , after treatment and in 6 months follow-up visit after treatment in the two groups .
METHODS	The clinical efficacy was compared between the two groups .
RESULTS	After treatment and in 6 months follow-up visit after treatment , the symptom scores , physical sign scores and symptom scores of each item were different signi ficantly as compared with those before treatment in the triple-strong stimulation therapy group ( P < 0.01 , P < 0.05 ) , and the results in the triple-strong stimulation therapy group were better than those in the acupoint plaster therapy group ( all P < 0.01 ) .
RESULTS	In 6 months follow-up visit , the total effective rate was 94.6 % ( 53/56 ) in the triple-strong stimulation therapy group and was 25.9 % ( 15/58 ) in the acupoint plaster therapy group , indicating the significant difference ( P < 0.001 ) .
CONCLUSIONS	The triple-strong stimulation therapy at Dazhui ( GV 14 ) achieves the superior effect on the prevention and treatment of children allergic rhinitis as compared with the acupoint plas ter therapy and has good long-term effect of the prevention from recurrence .

###24445560
OBJECTIVE	Postoperative pain is an important health-care issue .
OBJECTIVE	Patient-controlled analgesia ( PCA ) is considered the gold standard for systemic postoperative pain treatment .
OBJECTIVE	Methadone PCA is used for patients with chronic pain and those in the palliative care setting .
OBJECTIVE	However , its efficacy as a first-line drug for acute postoperative pain is unknown .
OBJECTIVE	This study evaluated the use of postoperative methadone PCA after total hip arthroplasty ( THA ) compared with morphine PCA .
METHODS	This was a randomized , double-blind , controlled , parallel-group study .
METHODS	Patients were randomized into two groups : group methadone -- methadone PCA , and group morphine -- morphine PCA , for postoperative analgesia .
METHODS	Drugs were delivered through PCA pumps throughout the first 24 h after surgery ( T1 :6 , T2 :12 , T3 :18 , T4 :24 h ) .
RESULTS	Opioid consumption in 24 h was significantly lower for group methadone than for group morphine .
RESULTS	Group methadone patients experienced significantly less pain than group morphine at rest .
RESULTS	Pain after movement was significantly lower in group methadone at T1 and T3 and marginally lower at T2 and T4 .
RESULTS	Adverse events more frequently reported were sleepiness , nausea , and vomiting , but no statistical difference between groups was found .
CONCLUSIONS	This study demonstrated that methadone PCA prompted less opioid consumption and lower pain scores at rest and at motion in comparison with morphine PCA as postoperative analgesia after THA .

###24739896
BACKGROUND	The anti-EGFR monoclonal antibodies panitumumab and cetuximab are effective in patients with chemotherapy-refractory wild-type KRAS exon 2 metastatic colorectal cancer .
BACKGROUND	We assessed the efficacy and toxicity of panitumumab versus cetuximab in these patients .
METHODS	For this randomised , open-label , phase 3 head-to-head study , we enrolled patients ( from centres in North America , South America , Europe , Asia , Africa , and Australia ) aged 18 years or older with chemotherapy-refractory metastatic colorectal cancer , an Eastern Cooperative Oncology Group ( ECOG ) performance status of 2 or less , and wild-type KRAS exon 2 status .
METHODS	Using a computer-generated randomisation sequence , we assigned patients ( 1:1 ; stratified by geographical region and ECOG performance status , with a permuted block method ) to receive panitumumab ( 6 mg/kg once every 2 weeks ) or cetuximab ( initial dose 400 mg/m ( 2 ) ; 250 mg/m ( 2 ) once a week thereafter ) .
METHODS	The primary endpoint was overall survival assessed for non-inferiority ( retention of 50 % of the cetuximab treatment effect ; historical hazard ratio [ HR ] for cetuximab plus best supportive care vs best supportive care alone of 0.55 ) .
METHODS	The primary analysis included patients who received one or more dose of panitumumab or cetuximab , analysed per allocated treatment .
METHODS	Recruitment for this trial is closed .
METHODS	The trial is registered with ClinicalTrials.gov , number NCT01001377 .
RESULTS	Between Feb 2 , 2010 , and July 19 , 2012 , we enrolled and randomly allocated 1010 patients , 999 of whom began study treatment : 499 received panitumumab and 500 received cetuximab .
RESULTS	For the primary analysis of overall survival , panitumumab was non-inferior to cetuximab ( Z score -3.19 ; p = 0.0007 ) .
RESULTS	Median overall survival was 10.4 months ( 95 % CI 9.4-11 .6 ) with panitumumab and 10.0 months ( 9.3-11 .0 ) with cetuximab ( HR 0.97 ; 95 % CI 0.84-1 .11 ) .
RESULTS	Panitumumab retained 105.7 % ( 81.9-129 .5 ) of the effect of cetuximab on overall survival seen in this study .
RESULTS	The incidence of adverse events of any grade and grade 3-4 was similar across treatment groups .
RESULTS	Grade 3-4 skin toxicity occurred in 62 ( 13 % ) patients given panitumumab and 48 ( 10 % ) patients given cetuximab .
RESULTS	The occurrence of grade 3-4 infusion reactions was lower with panitumumab than with cetuximab ( one [ < 0.5 % ] patient vs nine [ 2 % ] patients ) , and the occurrence of grade 3-4 hypomagnesaemia was higher in the panitumumab group ( 35 [ 7 % ] vs 13 [ 3 % ] ) .
RESULTS	We recorded one treatment-related fatal adverse event : a lung infection in a patient given cetuximab .
CONCLUSIONS	Our findings show that panitumumab is non-inferior to cetuximab and that these agents provide similar overall survival benefit in this population of patients .
CONCLUSIONS	Both agents had toxicity profiles that were to be expected .
CONCLUSIONS	In view of the consistency in efficacy and toxicity seen , small but meaningful differences in the rate of grade 3-4 infusion reactions and differences in dose scheduling can guide physician choice of anti-EGFR treatment .

###25386630
OBJECTIVE	The present study was conducted to assess the effectiveness of Terminalia chebula on plaque and gingival inflammation and compare it with the gold standard chlorhexidine ( CHX 0.2 % ) and distilled water as control ( placebo ) .
METHODS	A double-blind randomised control trial was conducted among undergraduate students who volunteered .
METHODS	They were randomly allocated into three study groups : 1 ) Terminalia chebula mouthwash ( n = 30 ) ; 2 ) chlorhexidine ( active control ) ( n = 30 ) ; 3 ) distilled water ( placebo ) ( n = 30 ) .
METHODS	Assessment was carried out according to plaque score and gingival score .
METHODS	Statistical analysis was carried out to compare the effect of both mouthwashes .
METHODS	ANOVA and post-hoc LSD tests were performed using SPSS version 17 with p 0.05 considered statistically significant .
RESULTS	Our result showed that Terminalia chebula mouthrinse is as effective as chlorhexidine in reducing dental plaque and gingival inflammation .
RESULTS	The results demonstrated a significant reduction of gingival bleeding and plaque indices in both groups over a period of 15 and 30 days as compared to the placebo .
CONCLUSIONS	The results of the present study indicate that Terminalia chebula may prove to be an effective mouthwash .
CONCLUSIONS	Terminalia chebula extract mouthrinse can be used as an alternative to chlorhexidine mouthrinse as it has similar properties without the side-effects of the latter .

###25683116
OBJECTIVE	Celiac disease ( CeD ) is a prevalent autoimmune condition .
OBJECTIVE	Recurrent signs and symptoms are common despite treatment with a gluten-free diet ( GFD ) , yet no approved or proven nondietary treatment is available .
METHODS	In this multicenter , randomized , double-blind , placebo-controlled study , we assessed larazotide acetate 0.5 , 1 , or 2 mg 3 times daily to relieve ongoing symptoms in 342 adults with CeD who had been on a GFD for 12 months or longer and maintained their current GFD during the study .
METHODS	The study included a 4-week placebo run-in , 12 weeks of treatment , and a 4-week placebo run-out phase .
METHODS	The primary end point was the difference in average on-treatment Celiac Disease Gastrointestinal Symptom Rating Scale score .
RESULTS	The primary end point was met with the 0.5-mg dose of larazotide acetate , with fewer symptoms compared with placebo by modified intention to treat ( n = 340 ) ( analysis of covariance , P = .022 ; mixed model for repeated measures , P = .005 ) .
RESULTS	The 0.5-mg dose showed an effect on exploratory end points including a 26 % decrease in celiac disease patient-reported outcome symptomatic days ( P = .017 ) , a 31 % increase in improved symptom days ( P = .034 ) , a 50 % or more reduction from baseline of the weekly average abdominal pain score for 6 or more of 12 weeks of treatment ( P = .022 ) , and a decrease in the nongastrointestinal symptoms of headache and tiredness ( P = .010 ) .
RESULTS	The 1 - and 2-mg doses were no different than placebo for any end point .
RESULTS	Safety was comparable with placebo .
CONCLUSIONS	Larazotide acetate 0.5 mg reduced signs and symptoms in CeD patients on a GFD better than a GFD alone .
CONCLUSIONS	Although results were mixed , this study was a successful trial of a novel therapeutic agent targeting tight junction regulation in patients with CeD who are symptomatic despite a GFD .
CONCLUSIONS	Clinicaltrials.gov : NCT01396213 .

###24289920
OBJECTIVE	To evaluate the effect of eculizumab , a systemic inhibitor of complement component ( C5 ) , on the growth of geographic atrophy ( GA ) in patients with age-related macular degeneration ( AMD ) .
METHODS	Prospective , double-masked , randomized clinical trial .
METHODS	Patients with GA measuring from 1.25 to 18 mm ( 2 ) based on spectral-domain optical coherence tomography imaging .
METHODS	Patients were randomized 2:1 to receive intravenous eculizumab or placebo over 6 months .
METHODS	In the eculizumab treatment arm , the first 10 patients received a low-dose regimen of 600 mg weekly for 4 weeks followed by 900 mg every 2 weeks until week 24 , and the next 10 patients received a high-dose regimen of 900 mg weekly for 4 weeks followed by 1200 mg every 2 weeks until week 24 .
METHODS	The placebo group was infused with saline .
METHODS	Patients were observed off treatment for an additional 26 weeks .
METHODS	Both normal-luminance and low-luminance visual acuities were measured throughout the study , and the low-luminance deficits were calculated as the difference between the letter scores .
METHODS	Change in area of GA at 26 weeks .
RESULTS	Thirty eyes of 30 patients were enrolled .
RESULTS	Eighteen fellow eyes also met inclusion criteria and were analyzed as a secondary endpoint .
RESULTS	For the 30 study eyes , mean square root of GA area measurements standard deviation at baseline were 2.55 0.94 and 2.02 0.74 mm in the eculizumab and placebo groups , respectively ( P = 0.13 ) .
RESULTS	At 26 weeks , GA enlarged by a mean of 0.19 0.12 and 0.18 0.15 mm in the eculizumab and placebo groups , respectively ( P = 0.96 ) .
RESULTS	At 52 weeks of follow-up , GA enlarged by a mean of 0.37 0.22 mm in the eculizumab-treated eyes and by a mean of 0.37 0.21 mm in the placebo group ( P = 0.93 , 2 sample t test ) .
RESULTS	None of the eyes converted to wet AMD .
RESULTS	No drug-related adverse events were identified .
CONCLUSIONS	Systemic complement inhibition with eculizumab was well tolerated through 6 months but did not decrease the growth rate of GA significantly .
CONCLUSIONS	However , there was a statistically significant correlation between the low-luminance deficit at baseline and the progression of GA over 6 months .

###24702135
BACKGROUND	We present a clinical trial establishing the feasibility of a control-to-range ( CTR ) closed-loop system informed by heart rate ( HR ) and assess the effect of HR information added to CTR on the risk for hypoglycemia during and after exercise .
METHODS	Twelve subjects with type 1 diabetes ( five men , seven women ; weight , 68.9 3.1 kg ; age , 38 3.3 years ; glycated hemoglobin , 6.9 0.2 % ) participated in a randomized crossover clinical trial comparing CTR versus CTR+HR in two 26-h admissions , each including 30 min of mild exercise .
METHODS	The CTR algorithm was implemented in the DiAs portable artificial pancreas platform based on an Android ( ) ( Google , Mountainview , CA ) smartphone .
METHODS	We assessed blood glucose ( BG ) decline during exercise , the Low BG Index ( LBGI ) ( a measure of hypoglycemic risk ) , number of hypoglycemic episodes ( BG < 70 mg/dL ) and overall glucose control ( percentage time within the target range 70 mg/dL BG 180 mg/dL ) .
RESULTS	Using HR to inform the CTR algorithm reduced significantly the BG decline during exercise ( P = 0.022 ) , indicated marginally lower LBGI ( P = 0.3 ) and fewer hypoglycemic events during exercise ( none vs. two events ; P = 0.16 ) , and resulted in overall higher percentage time within the target range ( 81 % vs. 75 % ; P = 0.2 ) .
RESULTS	LBGI and average BG remained unchanged overall , during recovery , and overnight .
CONCLUSIONS	HR-informed closed-loop control can be implemented in a portable artificial pancreas .
CONCLUSIONS	Although closed loop has been shown to reduce hypoglycemia , adding HR signal may further limit the risk for hypoglycemia during and immediately after exercise .
CONCLUSIONS	The most prominent effect of adding HR information is reduced BG decline during exercise , without deterioration of overall glycemic control .

###25219389
OBJECTIVE	Electroconvulsive therapy ( ECT ) is regarded by many clinicians as the most effective treatment for treatment-resistant bipolar depression , but no randomized controlled trials have been conducted , to the authors ' knowledge .
OBJECTIVE	They compared efficacy measures of ECT and algorithm-based pharmacological treatment in treatment-resistant bipolar depression .
METHODS	This multicenter , randomized controlled trial was carried out at seven acute-care psychiatric inpatient clinics throughout Norway and included 73 bipolar disorder patients with treatment-resistant depression .
METHODS	The patients were randomly assigned to receive either ECT or algorithm-based pharmacological treatment .
METHODS	ECT included three sessions per week for up to 6 weeks , right unilateral placement of stimulus electrodes , and brief pulse stimulation .
RESULTS	Linear mixed-effects modeling analysis revealed that ECT was significantly more effective than algorithm-based pharmacological treatment .
RESULTS	The mean scores at the end of the 6-week treatment period were lower for the ECT group than for the pharmacological treatment group : by 6.6 points on the Montgomery-sberg Depression Rating Scale ( SE = 2.05 , 95 % CI = 2.5-10 .6 ) , by 9.4 points on the 30-item version of the Inventory of Depressive Symptomatology-Clinician-Rated ( SE = 2.49 , 95 % CI = 4.6-14 .3 ) , and by 0.7 points on the Clinical Global Impression for Bipolar Disorder ( SE = 0.31 , 95 % CI = 0.13-1 .36 ) .
RESULTS	The response rate was significantly higher in the ECT group than in the group that received algorithm-based pharmacological treatment ( 73.9 % versus 35.0 % ) , but the remission rate did not differ between the groups ( 34.8 % versus 30.0 % ) .
CONCLUSIONS	Remission rates remained modest regardless of treatment choice for this challenging clinical condition .

###24219842
OBJECTIVE	To determine whether the Pediatric Asthma Control and Communication Instrument for the Emergency Department ( PACCI-ED ) , a 12-item questionnaire , can help ED attendings accurately assess a patient 's asthma control and morbidity .
METHODS	This was a randomized-controlled trial performed at an urban pediatric ED of children aged 1-17 years presenting with an asthma exacerbation .
METHODS	Parents answered PACCI-ED questions about their children 's asthma .
METHODS	Attendings were randomized to view responses to the PACCI-ED ( intervention group ) or to be blinded to the completed PACCI-ED ( control group ) .
METHODS	The two groups were compared on their empirical clinical assessment of : ( 1 ) chronic asthma control categories , ( 2 ) asthma trajectory ( stable , worsening or improving ) , ( 3 ) patient adherence to controller medications , and ( 4 ) burden of disease for the patient 's family .
METHODS	The validated PACCI algorithm was used as the criterion standard for these four outcomes .
METHODS	Accuracy of clinical assessment was compared between intervention and control groups using chi-squared tests and an intention-to-treat approach .
RESULTS	Seventeen ED attendings were enrolled in the study and 77 children visits were included in the analysis .
RESULTS	There were no significant differences between the intervention and the control groups for child 's gender , age , race , and asthma characteristics .
RESULTS	Intervention group attendings were more accurate than control group attendings in assessing the category of chronic asthma control ( 43 % versus 19 % ; p = 0.03 ) , disease trajectory ( 72 % versus 45 % ; p = 0.02 ) , and the disease burden for families ( 74 % versus 35 % ; p = 0.001 ) over the past 12 months .
RESULTS	There was a trend towards more accuracy of intervention versus control attendings for estimating patient adherence to controller medications ( 72 % versus 48 % ; p = 0.06 ) .
CONCLUSIONS	The PACCI-ED improves the assessment of asthma control , trajectory , and burden by ED attendings , and may help assessment of asthma medication adherence and prior asthma exacerbations .
CONCLUSIONS	The PACCI-ED can be used to improve provider assessment of asthma morbidity during pediatric ED visits for asthma exacerbations , and to identify children who may benefit from interventions to reduce asthma morbidity .

###24565591
BACKGROUND	Remote ischemic preconditioning by transient limb ischemia reduces myocardial ischemia-reperfusion injury in patients undergoing percutaneous coronary intervention .
BACKGROUND	The aim of the study we report here was to assess the effect of remote ischemic preconditioning on endothelial function in patients with acute myocardial infarction who underwent primary percutaneous coronary intervention .
METHODS	Forty-eight patients with acute myocardial infarction were enrolled .
METHODS	All participants were randomly divided into 2 groups .
METHODS	In Group I ( n = 23 ) , remote ischemic preconditioning was performed before primary percutaneous coronary intervention ( intermittent arm ischemia-reperfusion through 4 cycles of 5-minute inflation and 5-minute deflation of a blood-pressure cuff to 200 mm Hg ) .
METHODS	In Group II ( n = 25 ) , standard percutaneous coronary intervention without preconditioning was performed .
METHODS	We assessed endothelial function using the flow-mediated dilation test on baseline , then within 1-3 hours after percutaneous coronary intervention , and again on days 2 and 7 after percutaneous coronary intervention .
RESULTS	The brachial artery flow-mediated dilation results were significantly higher on the first day after primary percutaneous coronary intervention in the preconditioning group ( Group I ) than in the control group ( Group II ) ( 12.1 % vs 0.0 % , P = .03 , and 11.1 % vs 6.3 % , P = .016 , respectively ) , and this difference remained on the seventh day ( 12.3 % vs 7.4 % , P = .0005 , respectively ) .
CONCLUSIONS	We demonstrated for the first time that remote ischemic preconditioning before primary percutaneous coronary intervention significantly improves endothelial function in patients with acute myocardial infarction , and this effect remains constant for at least a week .
CONCLUSIONS	We suppose that the improvement of endothelial function may be one of the possible explanations of the effect of remote ischemic preconditioning .

###24800383
BACKGROUND	The use of email and website as channels for workplace health information delivery is not fully explored .
BACKGROUND	This study aims to describe the rationale , design , and baseline findings of an email-linked website intervention to improve modifiable cancer risk factors .
METHODS	Employees of a Malaysian public university were recruited by systematic random sampling and randomised into an intervention ( n = 174 ) or control group ( n = 165 ) .
METHODS	A website was developed for the intervention and educational modules were uploaded onto the website .
METHODS	The intervention group received ten consecutive weekly emails with hypertext links to the website for downloading the modules and two individual phone calls as motivational support whilst the control group received none .
METHODS	Diet , lifestyle , anthropometric measurements , psychosocial factors and stages of change related to dietary fat , fruit and vegetable intake , and physical activity were assessed .
RESULTS	Participants were predominantly female and in non-academic positions .
RESULTS	Obesity was prevalent in 15 % and 37 % were at risk of co-morbidities .
RESULTS	Mean intake of fats was 31 % , fruit was -1 serving/day and vegetable was < 1 serving/day .
RESULTS	Less than 20 % smoked and drank alcohol and about 40 % were physically inactive .
RESULTS	The majority of the participants fell into the Preparation stage for decreasing fat intake , eating more fruit and vegetables , and increasing physical activity .
RESULTS	Self-efficacy and perceived benefits were lowest among participants in the Precontemplation/Contemplation stage compared to the Preparation and Action/Maintenance stages .
CONCLUSIONS	Baseline data show that dietary and lifestyle practices among the employees did not meet the international guidelines for cancer prevention .
CONCLUSIONS	Hence the findings warrant the intervention planned .

###25065293
BACKGROUND	The TACT trial ( CRUK/01/001 ) compared adjuvant sequential FEC-docetaxel ( FEC-D ) chemotherapy with standard anthracycline-based chemotherapy of similar duration in women with early breast cancer .
BACKGROUND	Results at a median of 5 years suggested no improvement in disease-free survival with FEC-D .
BACKGROUND	Given differing toxicity profiles of the regimens , the impact on quality of life ( QL ) was explored .
METHODS	Patients from 44 centres completed standardised QL questionnaires before chemotherapy , after cycles 4 and 8 , at 9 , 12 , 18 and 24 months and at 6 years follow-up .
METHODS	Patient diaries assessed frequency , associated distress and impact on daily activity of 15 treatment related side effects .
RESULTS	830 patients ( 415 FEC-D ; 415 controls ) contributed assessments during 0-24 months ; 362 of whom participated again at 6 years .
RESULTS	During chemotherapy , FEC-D impaired global health/QL and depression rates and significantly more QL domains than standard regimens .
RESULTS	Novel diary card ratings highlighted significantly more distress and interference with daily activities due to FEC-D side effects compared with standard treatment .
RESULTS	In both groups , most QL parameters returned to baseline levels by 2 years and were unchanged at 6 years .
CONCLUSIONS	Within expected negative effects of chemotherapy on wide ranging QL domains FEC-D patients reported greater toxicity , disruption and distress during treatment with no improvement in disease outcome at 5 years than patients receiving standard anthracycline-based chemotherapy .
CONCLUSIONS	Findings should inform future patients of relative costs and benefits of adjuvant chemotherapy .

###26092816
BACKGROUND	The combined efficacy analysis of the TEXT and SOFT trials showed a significant disease-free survival benefit with exemestane plus ovarian function suppression ( OFS ) compared with tamoxifen plus OFS .
BACKGROUND	We present patient-reported outcomes from these trials .
METHODS	Between Nov 7 , 2003 , and April 7 , 2011 , 4717 premenopausal women with hormone-receptor positive breast cancer were enrolled in TEXT or SOFT to receive unmasked adjuvant treatment with 5 years of exemestane plus OFS or tamoxifen plus OFS .
METHODS	Gonadotropin-releasing hormone analogue triptorelin , bilateral oophorectomy , or bilateral ovarian irradiation were used to achieve OFS .
METHODS	Chemotherapy use was optional .
METHODS	Randomisation with permuted blocks was done with the International Breast Cancer Study Group 's internet-based system and was stratified by chemotherapy use and status of lymph nodes .
METHODS	Patients completed a quality of life ( QoL ) form comprising several global and symptom indicators at baseline , every 6 months for 24 months , and then every year during years 3 to 6 .
METHODS	Differences in the change of QoL from baseline between the two treatments were tested at 6 months , 24 months , and 60 months with mixed-models for repeated measures for each trial with and without chemotherapy and overall .
METHODS	The analysis was by intention to treat .
METHODS	At the time of analysis , the median follow-up was 57 years ( IQR 37-69 ) ; treatment and follow-up of patients continue .
METHODS	The trials are registered with ClinicalTrials.gov , as NCT00066703 ( TEXT ) and NCT00066690 ( SOFT ) .
RESULTS	Patients on tamoxifen plus OFS were more affected by hot flushes and sweats over 5 years than were those on exemestane plus OFS , although these symptoms improved .
RESULTS	Patients on exemestane plus OFS reported more vaginal dryness , greater loss of sexual interest , and difficulties becoming aroused than did patients on tamoxifen plus OFS ; these differences persisted over time .
RESULTS	An increase in bone or joint pain was more pronounced , particularly in the short term , in patients on exemestane plus OFS than patients on tamoxifen plus OFS .
RESULTS	Changes in global QoL indicators from baseline were small and similar between treatments over the 5 years .
CONCLUSIONS	Overall , from a QoL perspective , there is no strong indication to favour either exemestane plus OFS or tamoxifen plus OFS .
CONCLUSIONS	The distinct effects of the two treatments on the burden of endocrine symptoms need to be addressed with patients individually .
BACKGROUND	Pfizer , International Breast Cancer Study Group , and US National Cancer Institute .

###24274806
OBJECTIVE	Coaction refers to the extent to which taking action on one behavior increases the odds of taking action on a second behavior .
OBJECTIVE	This integrative study examines the generalization of coaction in three studies on weight-related behaviors .
METHODS	Data from three randomized trials of tailored interventions ( n = 1,277 , n = 1,800 , and n = 6,000 ) were examined to determine if coaction of behavior change occurred differentially in treatment and control groups .
METHODS	In each analysis , the likelihood of progressing to the Action or Maintenance stages for the target behaviors was evaluated using logistic regression .
RESULTS	Despite differences in populations , targeted behaviors , levels of tailoring in interventions , and timing of follow-up assessments , 17 out of 24 ( 70.8 % ) logistic regressions revealed significant coaction in the treatment group as opposed to only three out of 24 ( 12.5 % ) in the control condition .
RESULTS	In 23/24 analyses , coaction of behavior change was larger on an absolute basis in the treatment group .
RESULTS	Individuals in the treatment group progressing to Action/Maintenance for one behavior were 1.4-5 times more likely to make progress on another behavior compared to those in the treatment group who did not make such progress on the first behavior .
CONCLUSIONS	This study demonstrates that despite considerable variability in study design , coaction reliably occurs more in the presence of Transtheoretical-Model based multiple behavior change interventions .
CONCLUSIONS	Additional studies are needed to replicate these results in other behavioral areas and to examine the predictors of differential coaction .
CONCLUSIONS	The ability to consistently create coaction within multiple behavior interventions can increase the efficacy and cost-effectiveness of multiple behavior change interventions .

###24552306
BACKGROUND	Routine tuberculosis culture remains unavailable in many high-burden areas , including Tanzania .
BACKGROUND	This study sought to determine the impact of providing mycobacterial culture results over standard of care [ unconcentrated acid-fast ( AFB ) smears ] on management of persons with suspected tuberculosis .
METHODS	Adults and children with suspected tuberculosis were randomized to standard ( direct AFB smear only ) or intensified ( concentrated AFB smear and tuberculosis culture ) diagnostics and followed for 8weeks .
METHODS	The primary endpoint was appropriate treatment ( i.e. antituberculosis therapy for those with tuberculosis , no antituberculous therapy for those without tuberculosis ) .
RESULTS	Seventy participants were randomized to standard ( n = 37 , 53 % ) or intensive ( n = 33 , 47 % ) diagnostics .
RESULTS	At 8weeks , 100 % ( n = 22 ) of participants in follow up randomized to intensive diagnostics were receiving appropriate care , vs. 22 ( 88 % ) of 25 participants randomized to standard diagnostics ( p = 0.14 ) .
RESULTS	Overall , 18 ( 26 % ) participants died ; antituberculosis therapy was associated with lower mortality ( 9 % who received antiuberculosis treatment died vs. 26 % who did not , p = 0.04 ) .
CONCLUSIONS	Under field conditions in a high burden setting , the impact of intensified diagnostics was blunted by high early mortality .
CONCLUSIONS	Enhanced availability of rapid diagnostics must be linked to earlier access to care for outcomes to improve .

###25052708
OBJECTIVE	Patients with frontal lobe epilepsy ( FLE ) commonly demonstrate motor impairments , suggesting that frontal lobe seizures affect motor function .
OBJECTIVE	However , the underlying mechanisms of these deficits are not known , nor has any study systematically examined motor organization in these patients .
OBJECTIVE	We therefore examined cortical motor organization in a group of adult patients with FLE , using task-based fMRI .
METHODS	Eleven right FLE patients , six left FLE patients , and ten control subjects underwent task-based fMRI .
METHODS	Two tasks were performed using the right and left hands separately , and both hands together .
METHODS	The first task was a finger-tapping task and the second task was a more complex coordination task .
METHODS	Functional MR data were compared between patient groups and controls .
METHODS	A laterality index of brain activation was also calculated between the epileptic and healthy hemisphere to determine hemispheric dominance during task performance to explore its relationship with a variety of patient-specific epilepsy factors .
RESULTS	Overall , right FLE patients demonstrated decreased BOLD activity in the epileptic hemisphere and increased BOLD activity in the healthy hemisphere compared to controls ( p < 0.05 ) .
RESULTS	The comparison of left FLE patients to controls provided less conclusive differences , possibly due to the low number of left FLE patients studied .
RESULTS	Laterality indices of the coordination task were positively correlated to the number of months since the last seizure in both patient groups ( right FLE : rs = 0.779 , left FLE : rs = 0.943 ) .
RESULTS	Patients that had experienced a recent seizure relied more on the sensorimotor cortex of the healthy hemisphere during task performance , compared to those that were relatively seizure free ( p < 0.05 ) .
CONCLUSIONS	Patients with FLE exhibited changes in motor BOLD activity that was dependent on the duration of seizure freedom .
CONCLUSIONS	These results demonstrate the presence of seizure-related alteration of cortical motor organization in FLE , which may underlie the motor deficits seen in these patients .

###24865441
OBJECTIVE	To examine the psychological sequelae associated with abnormal screening in the United Kingdom Collaborative Trial of Ovarian Cancer Screening ( UKCTOCS ) .
METHODS	Prospective , longitudinal randomised control trial .
METHODS	Sixteen UKCTOCS centres .
METHODS	Women aged 50-70 years randomised to annual multimodal screening , ultrasound screening or control groups .
METHODS	Two groups were followed for 7 years : ( 1 ) a random sample ( n = 1339 ) , taken from all three study groups ; and ( 2 ) an events sample ( n = 22,035 ) of women with abnormal screens resulting in the need for repeat testing of either low or higher level intensity .
METHODS	Patient-reported measures of anxiety ( scores ranging from 20 to 80 ) and psychological morbidity .
RESULTS	In the random sample the mean difference between anxiety scores after a repeat screening and those following an annual screening was 0.4 ( 95 % CI -0.46 , 1.27 ) , and in the events sample it was 0.37 ( 95 % CI 0.23 , 0.51 ) .
RESULTS	The risk of psychological morbidity was only increased in the event sample for women requiring higher level repeat screening ( OR 1.28 ; 95 % CI 1.18 , 1.39 ) .
RESULTS	The risk of psychological morbidity in women with ovarian cancer was higher at both 6 weeks ( OR 16.2 ; 95 % CI 9.19 , 28.54 ) and 6 months ( OR 3.32 ; 95 % CI 1.91 , 5.77 ) following surgery .
CONCLUSIONS	Screening does not appear to raise anxiety but psychological morbidity is elevated by more intense repeat testing following abnormal annual screens , and in women after surgical treatment for ovarian cancer .

###24684807
BACKGROUND	Lactate is a marker of hypoperfusion and may be used for risk assessment in critically ill patients .
BACKGROUND	Although evidence suggests that repeated lactate measurements are of clinical interest , how and when lactate should be analyzed is controversial .
BACKGROUND	Intravascular microdialysis provides a novel method for the continuous monitoring of lactate , which may be clinically beneficial in critically ill patients .
METHODS	Circulating lactate levels were continuously monitored in 80 patients undergoing cardiac surgery using either a separate single-lumen microdialysis catheter or a triple-lumen central venous catheter with an integrated microdialysis function .
METHODS	The catheter was placed with the tip positioned in the superior vena cava .
METHODS	Arterial blood gas samples were taken every hour to obtain reference values , and the lactate levels were analyzed in a blood gas analyzer .
RESULTS	A total of 1,601 paired microdialysis-arterial blood gas lactate samples were obtained .
RESULTS	Bland-Altman analysis showed a bias ( mean difference ) limits of agreement ( 1.96 SD ) of 0.020.42 mmol/L .
RESULTS	The regression coefficient was 0.98 ( P = 0.0001 ) .
CONCLUSIONS	Central venous microdialysis is an accurate and reliable method for continuous blood lactate monitoring in patients undergoing cardiac surgery .
CONCLUSIONS	The system may be useful for early lactate-guided therapy in critically ill patients .

###24710641
OBJECTIVE	The objective of this study was to evaluate and compare the effects of gliclazide-modified release ( gliclazide-MR ) , metformine ( MET ) and pioglitazone ( PIO ) monotherapies on glycemic control and conventional/non-conventional cardiovascular risk factors in patients with newly diagnosed type 2 diabetes mellitus ( T2DM ) .
METHODS	A single center , randomized , 52-wk comparator-controlled clinical study was carried out in patients with newly diagnosed uncontrolled T2DM .
METHODS	A total of 57 patients were randomized into gliclazide-MR , metformin and pioglitazone groups .
METHODS	Drugs were administered for 12 months .
METHODS	Anthropometric measurements , fasting plasma glucose ( FPG ) , postprandial plasma glucose ( PPG ) , HbA1c , insulin , HOMA-IR , lipid parameters , the markers of coagulation/fibrinolysis , inflammation and endothelial dysfunction were measured at baseline and at months 3 , 6 , and 12 .
RESULTS	In the gliclazide-MR group , HC , FPG , HbA1c , insulin , HOMA-IR , TC , trigylcerides , Lp ( a ) , E-selectin and Hcy were significantly decreased after treatment compared to baseline .
RESULTS	In the MET group , BMI , WC , FPG , PPG , HbA1c , ICAM-1 and Hcy significantly decreased after treatment compared to baseline .
RESULTS	In PIO group , WC , HC , FPG , PPG , HbA1c , C-peptid , HOMA-IR , trigylcerides , vWF , IL-6 , ICAM-1 , E-selectin and Hcy significantly decreased after treatment compared to baseline , whereas , HDL-C increased .
RESULTS	At the end of the month 12 , the decreases in insulin and HOMA-IR score were more pronounced with PIO compared to gliclazide .
CONCLUSIONS	Gliclazide-MR , MET and PIO monotherapies , were equally effective in proving glycemic control in patients with newly diagnosed , oral antidiabetic ( OAD ) - naive T2DM .
CONCLUSIONS	But , improvements in conventional/non-conventional cardiovascular risk factors were more pronounced in patients on PIO therapy compared to gliclazide and MET therapies .
CONCLUSIONS	Also , all of the 3 drugs represent effective and safe first-line pharmacological treatment options in these patients .

###26109580
BACKGROUND	In our increasingly obesogenic environment , in which high-calorie convenience foods are readily available , food choices can drastically affect weight and overall health .
BACKGROUND	Learned food preferences , which are developed through repeated pairings with positively and negatively valenced stimuli , can contribute to obesity susceptibility if positive attitudes toward high-calorie foods are developed .
BACKGROUND	Thus , the modification of automatic associations with food may be a viable strategy to promote healthier eating behaviors .
OBJECTIVE	In this study , we investigated the ability of an implicit priming ( IP ) intervention to alter responses to visual food cues by using an evaluative conditioning approach .
OBJECTIVE	The main objective was to implicitly ( i.e. , below conscious perception ) associate disgust with high-calorie foods with the aim of reducing liking of these foods .
METHODS	Participants were randomly assigned to active or control IP .
METHODS	In active IP ( n = 22 ) , high-calorie food images were implicitly primed with negatively valenced images , and low-calorie food images were implicitly primed with positively valenced images .
METHODS	In control IP ( n = 20 ) , all food images were primed with neutral images of fixation crosses .
METHODS	Food images were rated on the desire to eat immediately before and after IP .
RESULTS	A significant main effect of calorie ( high compared with low ; P < 0.001 ) and a significant calorie-by-group ( active compared with control ) interaction ( P = 0.025 ) were observed .
RESULTS	Post hoc tests identified a significantly greater high-calorie rating decline after active IP than after control IP ( P = 0.036 ) .
RESULTS	Furthermore , there was significantly greater change in high-calorie ratings than in low-calorie ratings in the active group ( P = 0.001 ) .
RESULTS	Active IP effects extended to high-calorie foods not specifically included in the intervention , which suggested an effect generalization .
RESULTS	Moreover , a greater change in high-calorie ratings than in low-calorie ratings persisted 3-5 d after active IP ( P < 0.007 ) , which suggested lasting effects .
CONCLUSIONS	This study provides initial evidence that IP can be used to alter high-calorie food preferences , which could promote healthier eating habits .

###24768240
OBJECTIVE	To compare 3-year outcomes and complications of the Ahmed FP7 Glaucoma Valve ( AGV ) ( New World Medical , Cucamonga , CA ) and the Baerveldt Glaucoma Implant ( BGI ) 101-350 ( Abbott Medical Optics , Abbott Park , IL ) for the treatment of refractory glaucoma .
METHODS	Multicenter , randomized , controlled clinical trial .
METHODS	A total of 276 patients : 143 in the AGV group and 133 in the BGI group .
METHODS	Patients aged 18 to 85 years with refractory glaucoma and intraocular pressures ( IOPs ) 18 mmHg in whom an aqueous shunt was planned were randomized to an AGV or a BGI .
METHODS	The IOP , visual acuity ( VA ) , supplemental medical therapy , complications , and failure ( IOP > 21 mmHg or not reduced by 20 % from baseline , IOP < 5 mmHg , reoperation for glaucoma or removal of implant , or loss of light perception vision ) .
RESULTS	At 3 years , IOP ( mean standard deviation ) was 14.3 4.7 mmHg ( AGV group ) and 13.1 4.5 mmHg ( BGI group ) ( P = 0.086 ) on 2.0 1.4 and 1.5 1.4 glaucoma medications , respectively ( P = 0.020 ) .
RESULTS	The cumulative probabilities of failure were 31.3 % ( standard error [ SE ] , 4.0 % ) ( AGV ) and 32.3 % ( 4.2 % ) ( BGI ) ( P = 0.99 ) .
RESULTS	Postoperative complications associated with reoperation or vision loss of > 2 Snellen lines occurred in 24 patients ( 22 % ) ( AGV ) and 38 patients ( 36 % ) ( BGI ) ( P = 0.035 ) .
RESULTS	The mean change in the logarithm of the minimum angle of resolution VA at 3 years was similar ( AGV : 0.21 0.88 , BGI : 0.26 0.74 ) in the 2 treatment groups at 3 years ( P = 0.66 ) .
RESULTS	The cumulative proportion of patients ( SE ) undergoing reoperation for glaucoma before the 3-year postoperative time point was 14.5 % ( 3.0 % ) in the AGV group compared with 7.6 % ( 2.4 % ) in the BGI group ( P = 0.053 , log rank ) .
RESULTS	The relative risk of reoperation for glaucoma in the AGV group was 2.1 times that of the BGI group ( 95 % confidence interval , 1.0-4 .8 ; P = 0.045 , Cox proportional hazards regression ) .
CONCLUSIONS	Implantation of the AGV was associated with the need for significantly greater adjunctive medication to achieve equal success relative to implantation of the BGI and resulted in a greater relative risk of reoperation for glaucoma .
CONCLUSIONS	More subjects experienced serious postoperative complications in the BGI group than in the AGV group .

###24260106
OBJECTIVE	A new treatable venous disorder , chronic cerebrospinal venous insufficiency ( CCSVI ) , has been proposed in patients with multiple sclerosis .
OBJECTIVE	The natural course of CCSVI has not been examined yet .
OBJECTIVE	This is crucial given the fact that surgical procedures are increasingly offered to MS patients to treat venous stenosis .
METHODS	To document the natural course of venous haemodynamics we performed extra - and transcranial echo colour Doppler ( ECD ) in 52 multiple sclerosis patients and 28 healthy controls ( HC ) and re-examined this group after a median period of 16 weeks .
METHODS	The reexamination was done being blinded to the initial findings and the patients did not undergo any intervention .
RESULTS	The ECD examination at baseline showed CCSVI in 5 ( 9.6 % ) of the 52 multiple sclerosis patients and 0 HC ( P = 0.26 ) .
RESULTS	At follow-up the diagnosis CCSVI could not be reconfirmed in 3 out of 5 patients at follow-up , while 2 new CCSVI-positive multiple sclerosis patients were detected .
CONCLUSIONS	ECD examination shows a fluctuating natural course of the extracranial venous haemodynamics , which makes determination of CCSVI by ECD examination unreliable .

###25543426
OBJECTIVE	To explore the effective method of the prevention and treatment of procedural pain in dressing changes of burn wounds .
METHODS	Ninety patients of burn injury were randomized into 3 groups , 30 cases in each one .
METHODS	In the group A , fentanyl citrate injection was used at corresponding injury area , jiaogan ( AH6a , sympathetic nerve ) , fei ( CO14 , lung ) , neifenmi ( CO18 , endocrine ) on ear , 0.25 mL at each point .
METHODS	In the group B , fentanyl citrate injection was applied subcutaneously in the deltoid muscle , 1 mL .
METHODS	In the group C , 0.9 % sodium chloride injection was applied subcutaneously in the deltoid muscle , 1 mL .
METHODS	The visual analogue scale ( VAS ) was used to evaluate the analgesic effect before , during and 10 min after dressing change in the patients of the three groups separately .
RESULTS	It was not different in VAS score before dressing change among the three groups ( P > 0.05 ) .
RESULTS	Compared with that before dressing change , the pain was not significant and VAS score was not different during and after dressing change in the patients of the group A ( both P > 0.05 ) , but the score in the patients of the group B and C was different significantly ( all P < 0.05 ) .
RESULTS	The VAS score during and after dressing change in the group A was lower than that in the group B and C ( all P < 0.05 ) , and the score in the group B was lower than that in the group C ( P < 0.05 ) .
CONCLUSIONS	Fentanyl injection of small dose at auricular points achieves definite analgesic effect on procedural pain in dressing changes of burn wounds , superior to subcutaneous injection of fentanyl .

###24735134
BACKGROUND	In insulin-requiring type 2 diabetes patients , current insulin therapy approaches such as basal-alone or basal-bolus multiple daily injections ( MDI ) have not consistently provided achievement of optimal glycemic control .
BACKGROUND	Previous studies have suggested a potential benefit of continuous subcutaneous insulin infusion ( CSII ) in these patients .
BACKGROUND	The OpT2mise study is a multicenter , randomized , trial comparing CSII with MDI in a large cohort of subjects with evidence of persistent hyperglycemia despite previous MDI therapy .
METHODS	Subjects were enrolled into a run-in period for optimization of their MDI insulin regimen .
METHODS	Subjects showing persistent hyperglycemia ( glycated hemoglobin [ HbA1c ] 8 % and 12 % ) were then randomly assigned to CSII or continuing an MDI regimen for a 6-month phase followed by a single crossover of the MDI arm , switching to CSII .
METHODS	The primary end point is the between-group difference in mean change in HbA1c from baseline to 6 months .
METHODS	Secondary end points include change in mean 24-h glucose values , area under the curve and time spent in hypoglycemia and hyperglycemia , measures of glycemic excursions , change in postprandial hyperglycemia , and evaluation of treatment satisfaction .
METHODS	Safety end points include hypoglycemia , hospital admissions , and emergency room visits .
RESULTS	When subject enrollment was completed in May 2013 , 495 subjects had been enrolled in the study .
RESULTS	The study completion for the primary end point is expected in January 2014 .
CONCLUSIONS	OpT2mise will represent the largest studied homogeneous cohort of type 2 diabetes patients with persistent hyperglycemia despite optimized MDI therapy .
CONCLUSIONS	OpT2mise will help define the role of CSII in insulin intensification and define its safety , rate of hypoglycemia , patient adherence , and patient satisfaction .

###24378099
OBJECTIVE	To explore the effect of autologous cytokine-induced killer cells on the quality of life in patient with breast cancer who have already finished the adjuvant chemotherapy .
METHODS	One hundred and twenty-eight postoperative patients with breast cancer who underwent anthracycline-based adjuvant chemotherapy were enrolled in this prospective study , and they were randomized into 2 groups , i.e. , treatment group , which received the therapy of CIK cells transfusion , and control group , which was given regular follow-up .
METHODS	Meanwhile , patients with positive hormone receptor in the two groups were given endocrine therapy , and the patients with positive axillary lymph nodes were given radiotherapy to the chest wall and regional lymph nodes .
METHODS	The difference of quality of life between the two groups was analyzed according to the EORTC QLQ-BR53 quality of life questionnaire , and the adverse reactions were monitored .
RESULTS	As regarding the functional evaluation , the physical function scores of patients of the treatment group were ( 83.43 14.87 ) and ( 88.55 11.62 ) at 3 and 6 months after the CIK cell therapy , respectively , significantly higher than the baseline value [ ( 74.83 13.82 ) , P < 0.05 ) ] .
RESULTS	Global health status/QOL scores were ( 83.30 19.09 ) and ( 89.68 10.81 ) , significantly higher than the baseline value [ ( 77.72 21.05 ) , P < 0.05 ] .
RESULTS	As regarding symptoms , the scores of fatigue , nausea , vomiting and loss of appetite of patients in the treatment group were higher than the baseline value , with significant differences ( P < 0.05 ) .
RESULTS	The nausea and vomiting scores in the control group at 3 and 6 months of followed-up were ( 26.67 22.56 ) and ( 21.47 21.06 ) , significantly lower than the baseline values [ ( 33.31 27.07 ) , P < 0.05 ] .
RESULTS	The scores of worrying about the future in the patients of treatment group were ( 47.56 30.84 ) and ( 42.33 26.95 ) after 3 and 6 months , significantly better than the baseline value [ ( 57.41 30.63 ) , P < 0.05 ] .
RESULTS	The systematic therapy side effects scores were ( 31.95 27.52 ) and ( 23.72 22.87 ) , significantly better than the baseline value [ ( 40.56 26.28 ) , P < 0.05 ] .
RESULTS	The scores of arm edema were ( 45.26 25.42 ) and ( 36.61 20.51 ) , significantly milder than the baseline value [ ( 55.11 22.82 ) , P < 0.05 ] .
RESULTS	In the control group , the scores of arm edema were ( 44.85 28.94 ) and ( 38.64 23.68 ) , significantly lower than the baseline values [ ( 53.26 23.84 ) points , P < 0.05 ] .
RESULTS	Alopecia scores were ( 29.93 24.72 ) and ( 24.18 22.66 ) , significantly lower than the baseline values [ ( 35.92 22.08 ) , P < 0.05 ] .
RESULTS	In the treatment group , the patients ' physical function , social function and global health status/QOL , fatigue , insomnia , and worrying about the future rates were significantly higher than that of the control group ( P < 0.05 for all ) .
RESULTS	Three patients after CIK reinfusion had transient fever , and 6 cases felt pain in the lower limb , but the symptoms were relieved after symptomatic treatment .
CONCLUSIONS	Therapy of autologous CIK cells transfusion can significantly improve the quality of life of breast cancer patients , and the adverse reactions during the treatment can be alleviated by symptomatic treatment .

###24297971
BACKGROUND	In this partially randomised intervention study , we assessed the effect of social networks on the improvement of type 2 diabetes management in a largely African-American population in Baltimore .
METHODS	Patients in the intervention group ( n = 68 ) were asked to recruit peers , form small groups , and attend monthly diabetes education sessions , emphasising peer support .
METHODS	Patients in the control group ( n = 70 ) were recruited individually to attend standard diabetes education sessions .
METHODS	The primary outcomes were changes in haemoglobin A1C ( HbA1c ) and blood glucose .
METHODS	Secondary outcomes included blood pressure , weight , functional status , self-efficacy , perceived cohesion , social network connectedness and diabetes knowledge .
METHODS	General linear mixed models were built to assess mean absolute changes in primary and secondary outcomes at 3 and 6 months .
RESULTS	At 6 months from baseline , the social network intervention group achieved a larger reduction in HbA1c of -0.32 % ( p < 0.0001 ) and blood glucose of -10.6 mg/dL , ( p < 0.0001 ) compared to the control group .
RESULTS	In analyses of secondary endpoints , the intervention group had more favourable outcomes over time for weight , quality of life , self-efficacy , social network scores and diabetes knowledge , compared to the control group .
RESULTS	While blood pressure decreased , and perceived cohesion increased in both groups over the duration of the study , the difference between groups was not statistically significant .
CONCLUSIONS	The social networks intervention showed improved integration of patients within their existing networks leading to a greater reduction in HbA1c and blood glucose , as well as improved behaviour mediating outcomes .

###25137221
OBJECTIVE	While there is a dose-response relationship between physical activity ( PA ) and health benefit , little is known about the effectiveness of different PA prescriptions on total daily PA. .
OBJECTIVE	To test , under real-life conditions and using an objective , non-invasive measurement technique ( accelerometry ) , the effect of prescribing additional physical activity ( walking only ) of different durations ( 30 , 60 and 90 min/day ) on compliance ( to the activity prescribed ) and compensation ( to total daily PA ) .
OBJECTIVE	Participants in each group were prescribed 5 sessions of walking per week over 4 weeks .
METHODS	55 normal-weight and overweight women ( mean BMI 25 5 kg/m ( 2 ) , height 165 1 cm , weight 68 2 kg and mean age 27 1 years ) were randomly assigned to 3 prescription groups : 30 , 60 or 90 min/day PA. .
RESULTS	Walking duration resulted in an almost linear increase in the number of steps per day during the prescription period from an average of about 10,000 steps per day for the 30-min prescription to about 14,000 for the 90-min prescription .
RESULTS	Compliance was excellent for the 30-min prescription but decreased significantly with 60-min and 90-min prescriptions .
RESULTS	In parallel , degree of compensation subsequent to exercise increased progressively as length of prescription increased .
CONCLUSIONS	A 30-min prescription of extra walking 5 times per week was well tolerated .
CONCLUSIONS	However , in order to increase total PA further , much more than 60 min of walking may need to be prescribed in the majority of individuals .
CONCLUSIONS	While total exercise ` volume ' increased with prescriptions longer than 30 min , compliance to the prescription decreased and greater compensation was evident .

###25128051
OBJECTIVE	Many national colorectal cancer screening campaigns have a similar structure .
OBJECTIVE	First , individuals are invited to take a noninvasive screening test , and , second , in the case of a positive screening test result , they are advised to undergo a more invasive follow-up test .
OBJECTIVE	The objective of this study was to investigate how much individuals ' participation decision in noninvasive screening is affected by the presence or absence of detailed information about invasive follow-up testing and how this effect varies over screening tests .
METHODS	We used a labeled discrete choice experiment of three noninvasive colorectal cancer screening types with two versions that did or did not present respondents with detailed information about the possible invasive follow-up test ( i.e. , colonoscopy ) and its procedure .
METHODS	We used data from 631 Dutch respondents aged 55 to 75 years .
METHODS	Each respondent received only one of the two versions ( N = 310 for the invasive follow-up test information specification version , and N = 321 for the no-information specification version ) .
RESULTS	Mixed logit model results show that detailed information about the invasive follow-up test negatively affects screening participation decisions .
RESULTS	This effect can be explained mainly by a decrease in choice shares for the most preferred screening test ( a combined stool and blood sample test ) .
RESULTS	Choice share simulations based on the discrete choice experiment indicated that presenting invasive follow-up test information decreases screening participation by 4.79 % .
CONCLUSIONS	Detailed information about the invasive follow-up test has a negative effect on individuals ' screening participation decisions in noninvasive colorectal cancer screening campaigns .
CONCLUSIONS	This result poses new challenges for policymakers who aim not only to increase uptake but also to provide full disclosure to potential screening participants .

###25440215
OBJECTIVE	The purpose of this study was to examine the influence of instrument assisted soft tissue techniques ( IASTT ) on myofascial trigger points ( MTrP ) .
METHODS	Randomized , controlled study with the researcher assessing the MTrP sensitivity blinded to the treatment rendered .
METHODS	Phase 1 = 27 ; Phase 2 = 22 .
METHODS	MTrPs were identified in the upper back .
METHODS	In phase 1 , two MTrPs ( right & left ) were identified .
METHODS	One was treated with IASTT , the other was a control .
METHODS	In phase 2 , one MTrP was identified in a treatment and a control group .
METHODS	In each phase , the treatment groups received six treatments of IASTT .
METHODS	Sensitivity threshold of the MTrP was assessed with a dolorimeter .
RESULTS	There was a significant improvement in both groups over time but there was no difference between the treatment and control groups .
CONCLUSIONS	The use of a pressure dolorimeter may have served as a form of ischemic compression treatment .
CONCLUSIONS	This assessment tool may have been a mitigating factor in the over-shadowing any potential influence of the IASTT on the MTrP .
CONCLUSIONS	Thus , another assessment tool needs to be identified for MTrP assessment .
CONCLUSIONS	Until that technique is identified , the effect of IASTT on MTrPs in inconclusive .

###24246414
OBJECTIVE	Nowadays , advanced irradiation techniques make it possible to escalate safely the dose in prostate cancer .
OBJECTIVE	We studied the effect of a higher dose on tumor control in a randomized trial with a median follow-up of 110 months .
METHODS	Patients with T1b-T4N0 prostate cancer ( n = 664 ) were randomized between 78 Gy and 68 Gy .
METHODS	Primary endpoint was biochemical and/or clinical failure ( BCF ) according to the American Society for Therapeutic Radiology and Oncology ( ASTRO ) guidelines ( 3 consecutive rises ) , and to Phoenix ( nadir plus 2 g/L ) .
METHODS	Secondary endpoints were clinical failure ( CF ) , local failure ( LF ) , prostate cancer death ( PCD ) , and overall survival ( OS ) .
METHODS	Explorative subgroup analyses were performed .
RESULTS	BCF rate ( HR = 0.8 ; 20 % less events ) and LF rate ( HR = 0.5 ; 50 % less events ) were significantly lower in the 78 Gy arm ( p < 0.05 ) .
RESULTS	CF , PCD and OS were similar in both arms .
RESULTS	A significant heterogeneity of treatment effect was found for PSA cutoffs between 7 and 10 g/L .
CONCLUSIONS	We observed significantly less BCF and LF in the high-dose arm .
CONCLUSIONS	This suggests improvement of the therapeutic ratio .
CONCLUSIONS	However , we observed similar rates of CF and PCD at the current update .
CONCLUSIONS	More follow-up is needed to investigate which patients benefit in terms of prolonged OS .

###24957550
BACKGROUND	Breast cancer is characterized by great molecular heterogeneity demonstrated , e.g. by the intrinsic subtypes .
BACKGROUND	Administration of post-mastectomy radiotherapy ( PMRT ) does , however , not reflect this heterogeneity .
BACKGROUND	A gene profile ( DBCG-RT profile ) has recently been developed and validated , and has shown prognostic impact in terms of loco-regional failure and predictive impact for PMRT .
BACKGROUND	Reports have also shown predictive value in terms of benefit of PMRT from intrinsic subtypes and derived approximations .
BACKGROUND	The aim of this study was to examine : 1 ) the agreement between various methods for determining the intrinsic subtypes ; and 2 ) the relationship between the prognostic and predictive impact of the DBCG-RT profile and the intrinsic subtypes .
METHODS	Intrinsic subtypes and the DBCG-RT profile was determined from microarray analysis based on fresh frozen tissue from 191 patients included in the Danish Breast Cancer Cooperative Group ( DBCG ) 82bc trial .
METHODS	Corresponding formalin-fixed , paraffin-embedded tissue was available from 146 of these patients and from another 890 DBCG82bc patients .
METHODS	Estrogen receptor , progesterone receptor , HER2 , CK5/6 , Ki-67 and EGFR were combined into immunohistochemical approximations of the intrinsic subtypes .
METHODS	Endpoint considered was loco-regional recurrence ( LRR ) .
RESULTS	The DBCG-RT profile identified a group of patients with low risk of LRR and no additional benefit from PMRT among all subtypes .
RESULTS	Combining six immunohistochemical markers identified a subgroup of triple negative patients with high risk of LRR and significant benefit from PMRT .
RESULTS	Agreement in the different assignments of tumors to the subtypes was suboptimal , and the clinical outcome and predicted benefit from PMRT varied according to the method used for assignment .
CONCLUSIONS	The prognostic and predictive information obtained from the DBCG-RT profile can not be substituted by any approximation of the tumors intrinsic subtype .
CONCLUSIONS	The predictive value of the intrinsic subtypes in terms of PMRT was influenced by the method used for assignment to the intrinsic subtypes .

###24560435
OBJECTIVE	Investigate the effect of ankle taping on plantar-flexion strength , angle matching and force matching .
METHODS	Single group , repeated measures .
METHODS	Laboratory of an educational institution .
METHODS	Twenty uninjured females ( 22.93.6 years ) .
METHODS	Tape was applied to the ankle using a conventional hindfoot technique .
METHODS	Angle and force matching , and plantar-flexor strength were assessed using the purpose built dual ankle dynamometer , and measures were taken prior to and following taping .
METHODS	Angle matching was assessed passively and actively at 10 , 15 and 20 of plantar-flexion .
METHODS	Participants were required to match the angle of the reference leg with the contralateral leg .
METHODS	Force matching was assessed at 10 of plantar-flexion and participants matched the torque of the reference leg with the contralateral leg .
RESULTS	Taping had no effect on absolute errors during active or passive angle matching .
RESULTS	Regardless of taping , the ankle angle tested had a significant effect on passive angle matching ( p < 0.001 ) ; subjects were most accurate at matching a plantar-flexion angle of 20 .
RESULTS	Ankle taping had no effect on force matching .
RESULTS	Taping significantly improved peak plantar-flexion strength by 20 % ( p = 0.028 ) .
CONCLUSIONS	Ankle taping has little effect on contralateral force and angle matching , but it can enhance peak plantar-flexion strength .

###24339309
OBJECTIVE	Dexmedetomidine , a potent selective 2-adrenergic agonist , produces sedation and analgesia .
OBJECTIVE	This study was conducted to assess the effect of dexmedetomidine infusion on sevoflurane requirements , recovery profiles , and emergence agitation in children undergoing ambulatory surgery .
METHODS	Forty children undergoing ambulatory hernioplasty or orchiopexy were randomized into two groups .
METHODS	The dexmedetomidine group ( Group D , n = 20 ) received dexmedetomidine 1 g/kg , followed by 0.1 g/kg/h until the end of surgery , whereas the saline group ( Group S , n = 20 ) received volume-matched normal saline .
METHODS	Sevoflurane was used for induction and maintenance of anesthesia and caudal block was performed in all children .
METHODS	End-tidal sevoflurane concentration ( ET-sevo ) , the incidence of emergence agitation , pain scores , and sedation scores were recorded .
METHODS	Hemodynamic changes and other adverse effects were assessed in the perioperative period .
RESULTS	ET-sevo of Group D was significantly reduced in 23.8-67 % compared to Group S during surgery .
RESULTS	The incidence of emergence agitation was lower in Group D than in Group S ( 5 % vs. 55 % , p = 0.001 ) .
RESULTS	Postoperative pain was comparable , and discharge time was not different between the groups .
RESULTS	Mean arterial pressure and heart rate were significantly lower in Group D during surgery .
CONCLUSIONS	Intraoperative infusion of dexmedetomidine reduced sevoflurane requirements and decreased emergence agitation without delaying discharge in children undergoing ambulatory surgery .
CONCLUSIONS	However , caution should be taken in regard to bradycardia and hypotension .

###24951357
OBJECTIVE	To investigate the effects of oxytocin on high-intensity focused ultrasound ( HIFU ) ablation for the treatment of adenomyosis .
METHODS	Eighty-six patients with adenomyosis from three hospitals were randomly assigned to the oxytocin group or control group for HIFU treatment .
METHODS	During HIFU treatment , 80 units of oxytocin was added in 500ml of 0.9 % normal saline running at the rate of 2ml/min ( 0.32 U/min ) in the oxytocin group , while 0.9 % normal saline was used in the control group .
METHODS	Both patients and HIFU operators were blinded to oxytocin or saline application .
METHODS	Treatment results , adverse effects were compared .
RESULTS	When using oxytocin , the non-perfused volume ( NPV ) ratio was 80.711.6 % , the energy-efficiency factor ( EEF ) was 8.19.9 J/mm ( 3 ) , and the sonication time required to ablate 1cm ( 3 ) was 30.036.0 s/cm ( 3 ) .
RESULTS	When not using oxytocin , the non-perfused volume ratio was 70.816.7 % , the EEF was 15.819.6 J/mm ( 3 ) , and the sonication time required to ablate 1cm ( 3 ) was 58.272.7 S/cm ( 3 ) .
RESULTS	Significant difference in the NPV ratio , EEF , and the sonication time required to ablate 1cm ( 3 ) between the two groups was observed .
RESULTS	No oxytocin related adverse effects occurred .
CONCLUSIONS	Oxytocin could significantly decrease the energy for ablating adenomyosis with HIFU , safely enhance the treatment efficiency .

###24690309
OBJECTIVE	To assess agreement between meter and diary self monitoring of blood glucose ( SMBG ) records , over a year , in a sample of patients with type 2 diabetes .
METHODS	Meter and diary records were available , for 95 individuals , who took part in the Efficacy of self monitoring of blood glucose in patients with newly diagnosed type 2 diabetes study .
METHODS	Pearson 's correlation coefficient was used to explore the relationships between the types of error .
METHODS	Maximum likelihood estimation was used to explore changes over time through a structural equation modelling approach .
METHODS	Paired samples t-tests were used to determine if the presence of errors led to a significant difference between the mean diary and meter SMBG concentrations or coefficients of variation .
METHODS	Multiple regression was used to explore possible predictors of the error indices .
RESULTS	Mean over-reporting , under-reporting , concordance and overall reliability were 8.4 % , 10.0 % , 83.5 % and 71.3 % , respectively .
RESULTS	The first week of monitoring had significantly more under-reporting , over-reporting and less concordance and overall reliability than subsequent weeks .
RESULTS	The majority of concordance errors were not clinically significant .
RESULTS	Those that were , tended to occur during the first three months of monitoring .
RESULTS	Participants ' at one trial site were significantly more likely to have recording errors than those at the largest site .
CONCLUSIONS	Error levels were similar to those described previously in type 1 diabetes and there was a suggestion of an initial learning curve for record keeping .
CONCLUSIONS	For some individuals diary records would not be considered acceptable if held to the same standards as blood glucose meters .

###25132411
BACKGROUND	Secukinumab , a fully human anti-interleukin-17A monoclonal antibody , demonstrated efficacy and safety in moderate-to-severe plaque psoriasis when administered via subcutaneous injection .
BACKGROUND	Self-administration by pre-filled syringe ( PFS ) can offer patients clinical benefits of a drug , with increased convenience .
OBJECTIVE	To assess efficacy , safety and usability of secukinumab administration via PFS in subjects with moderate-to-severe plaque psoriasis .
METHODS	Subjects in this phase 3 trial were randomized 1:1:1 to secukinumab 300 or 150mg or matching placebo .
METHODS	Results to week 12 are presented here .
METHODS	Each treatment was delivered using a PFS once weekly to week 4 , and again at week 8 .
METHODS	Co-primary endpoints were secukinumab superiority over placebo for week 12 PASI 75 ( 75 % reduction in Psoriasis Area and Severity Index ) and IGA mod 2011 ( 2011 modified Investigator 's Global Assessment ) 0/1 response rates .
METHODS	Secondary endpoints included PFS usability , determined by observer rating of successful , hazard-free self-injection and subject rating of acceptability by the Self-Injection Assessment Questionnaire ( SIAQ ) .
RESULTS	Co-primary endpoints were met , with demonstration of superiority for each secukinumab dose vs. placebo at week 12 ( PASI 75 : 759 % , 695 % and 0 % for secukinumab 300mg , 150mg and placebo ; IGA mod 2011 0/1 : 690 % , 525 % and 0 % , respectively ; P < 00001 for all comparisons vs. placebo ) .
RESULTS	PFS usability was high : 100 % of subjects successfully self-administered treatment at week 1 , and subjects reported high SIAQ-assessed acceptability of the PFS throughout the trial .
RESULTS	No new/unexpected safety signals were observed .
CONCLUSIONS	Secukinumab administration by PFS was effective , with an acceptable safety profile and high usability .
CONCLUSIONS	The PFS provides a reliable , convenient form of secukinumab administration in subjects with moderate-to-severe plaque psoriasis .

###25432467
BACKGROUND	Exercise is an essential component of contemporary cardiac rehabilitation programs for the secondary prevention of coronary heart disease .
BACKGROUND	Despite the benefits associated with regular exercise , adherence with supervised exercise-based cardiac rehabilitation remains low .
BACKGROUND	Increasingly powerful mobile technologies , such as smartphones and wireless physiological sensors , may extend the capability of exercise-based cardiac rehabilitation by enabling real-time exercise monitoring for those with coronary heart disease .
BACKGROUND	This study compares the effectiveness of technology-assisted , home-based , remote monitored exercise-based cardiac rehabilitation ( REMOTE ) to standard supervised exercise-based cardiac rehabilitation in New Zealand adults with a diagnosis of coronary heart disease .
METHODS	A two-arm , parallel , non-inferiority , randomised controlled trial will be conducted at two sites in New Zealand .
METHODS	One hundred and sixty two participants will be randomised at a 1:1 ratio to receive a 12-week program of technology-assisted , home-based , remote monitored exercise-based cardiac rehabilitation ( intervention ) , or an 8-12 program of standard supervised exercise-based cardiac rehabilitation ( control ) .
METHODS	The primary outcome is post-treatment maximal oxygen uptake ( VO2max ) .
METHODS	Secondary outcomes include cardiovascular risk factors ( blood lipid and glucose concentrations , blood pressure , anthropometry ) , self-efficacy , intentions and motivation to be active , objectively measured physical activity , self-reported leisure time exercise and health-related quality of life .
METHODS	Cost information will also be collected to compare the two modes of delivery .
METHODS	All outcomes are assessed at baseline , post-treatment , and 6 months , except for VO2max , blood lipid and glucose concentrations , which are assessed at baseline and post-treatment only .
CONCLUSIONS	This novel study will compare the effectiveness of technology-supported exercise-based cardiac rehabilitation to a traditional supervised approach .
CONCLUSIONS	If the REMOTE program proves to be as effective as traditional cardiac rehabilitation , it has potential to augment current practice by increasing access for those who can not utilise existing services .
BACKGROUND	Australian New Zealand Clinical Trials RegistryStudy ID number : ACTRN12614000843651 .
BACKGROUND	Registered 7 August 2014 .

###24668315
OBJECTIVE	Acute pain after open abdominal hysterectomy limits the function of patients in the postoperative period , but data regarding the analgesic efficacy of a low dose of pregabalin ( 75 or 150 mg ) have been conflicting .
OBJECTIVE	This study was performed to determine if a low dose of pregabalin could decrease postoperative opioid use following abdominal hysterectomy when compared with placebo .
METHODS	American Society of Anesthesiologists I-II patients older than 18 yr and scheduled for open elective abdominal hysterectomy were recruited for participation and randomized to one of three groups : pregabalin 75 mg ( P75 ) , pregabalin 150 mg ( P150 ) , or placebo .
METHODS	The study drug was administered two hours prior to surgery and 12 hr following the initial dose .
METHODS	Anesthetic technique and postoperative analgesia were standardized .
METHODS	Postoperative pain was managed using patient-controlled analgesia with morphine .
METHODS	Pain at rest and movement as well as nausea were assessed with an 11-point numeric rating scale .
RESULTS	One hundred and one patients were recruited , and 89 patients completed the study .
RESULTS	Mean ( SD ) cumulative morphine consumption at 24 hr postoperatively was 54.0 ( 26.2 ) mg for the placebo group , 53.1 ( 22.7 ) mg for the P75 group , and 44.3 ( 20.9 ) mg for the P150 group .
RESULTS	Independent Student 's t tests indicated no difference between the placebo group and either the P75 group ( 95 % confidence interval [ CI ] : -11.75 to 13.44 ; P = 0.8937 ) or the P150 group ( 95 % CI : -2.74 to 22.15 ; P = 0.1238 ) .
CONCLUSIONS	At the doses used in this study , pregabalin treatment may not be effective in reducing opioid use up to 24 hr postoperatively following abdominal hysterectomy .
CONCLUSIONS	This trial was registered at www.ClinicalTrials.gov : NCT00781131 .

###24701581
OBJECTIVE	To investigate the effect of workplace neck/shoulder strength training with and without regular supervision on neck/shoulder pain and headache among office workers .
METHODS	A 20-week cluster randomized controlled trial among 351 office workers was randomized into three groups : two training groups with the same total amount of planned exercises three times per week ( 1 ) with supervision ( 3WS ) throughout the intervention period , ( 2 ) with minimal supervision ( 3MS ) only initially , and ( 3 ) a reference group ( REF ) .
METHODS	Main outcome is self-reported pain intensity in neck and shoulder ( scale 0-9 ) and headache ( scale 0-10 ) .
RESULTS	Intention-to-treat analyses showed a significant decrease in neck pain intensity the last 7 days in 3MS compared with REF : -0.5 0.2 ( P < 0.02 ) and a tendency for 3WS versus REF : -0.4 0.2 ( P < 0.07 ) .
RESULTS	Intensity of headache the last month decreased in both training groups : 3WS versus REF : -1.1 0.2 ( P < 0.001 ) and 3MS versus REF : -1.1 0.2 ( P < 0.001 ) .
RESULTS	Additionally , days of headache decreased 1.0 0.5 in 3WS and 1.3 0.5 in 3MS versus REF .
RESULTS	There were no differences between the two training groups for any of the variables .
CONCLUSIONS	Neck/shoulder training at the workplace reduced neck pain and headache among office workers independently of the extent of supervision .
CONCLUSIONS	This finding has important practical implications for future workplace interventions .

###25338498
OBJECTIVE	Preclinical data indicate anti-invasive activity of APG101 , a CD95 ligand ( CD95L ) - binding fusion protein , in glioblastoma .
METHODS	Patients ( N = 91 ) with glioblastoma at first or second progression were randomized 1:2 between second radiotherapy ( rRT ; 36 Gy ; five times 2 Gy per week ) or rRT + APG101 ( 400 mg weekly i.v. ) .
METHODS	Patient characteristics [ N = 84 ( 26 patients rRT , 58 patients rRT + APG101 ) ] were balanced .
RESULTS	Progression-free survival at 6 months ( PFS-6 ) rates were 3.8 % [ 95 % confidence interval ( CI ) , 0.1-19 .6 ] for rRT and 20.7 % ( 95 % CI , 11.2-33 .4 ) for rRT + APG101 ( P = 0.048 ) .
RESULTS	Median PFS was 2.5 ( 95 % CI , 2.3-3 .8 ) months and 4.5 ( 95 % CI , 3.7-5 .4 ) months with a hazard ratio ( HR ) of 0.49 ( 95 % CI , 0.27-0 .88 ; P = 0.0162 ) adjusted for tumor size .
RESULTS	Cox regression analysis adjusted for tumor size revealed a HR of 0.60 ( 95 % CI , 0.36-1 .01 ; P = 0.0559 ) for rRT + APG101 for death of any cause .
RESULTS	Lower methylation levels at CpG2 in the CD95L promoter in the tumor conferred a stronger risk reduction ( HR , 0.19 ; 95 % CI , 0.06-0 .58 ) for treatment with APG101 , suggesting a potential biomarker .
CONCLUSIONS	CD95 pathway inhibition in combination with rRT is an innovative concept with clinical efficacy .
CONCLUSIONS	It warrants further clinical development .
CONCLUSIONS	CD95L promoter methylation in the tumor may be developed as a biomarker .

###24988555
BACKGROUND	Epidural glucocorticoid injections are widely used to treat symptoms of lumbar spinal stenosis , a common cause of pain and disability in older adults .
BACKGROUND	However , rigorous data are lacking regarding the effectiveness and safety of these injections .
METHODS	In a double-blind , multisite trial , we randomly assigned 400 patients who had lumbar central spinal stenosis and moderate-to-severe leg pain and disability to receive epidural injections of glucocorticoids plus lidocaine or lidocaine alone .
METHODS	The patients received one or two injections before the primary outcome evaluation , performed 6 weeks after randomization and the first injection .
METHODS	The primary outcomes were the score on the Roland-Morris Disability Questionnaire ( RMDQ , in which scores range from 0 to 24 , with higher scores indicating greater physical disability ) and the rating of the intensity of leg pain ( on a scale from 0 to 10 , with 0 indicating no pain and 10 indicating `` pain as bad as you can imagine '' ) .
RESULTS	At 6 weeks , there were no significant between-group differences in the RMDQ score ( adjusted difference in the average treatment effect between the glucocorticoid-lidocaine group and the lidocaine-alone group , -1.0 points ; 95 % confidence interval [ CI ] , -2.1 to 0.1 ; P = 0.07 ) or the intensity of leg pain ( adjusted difference in the average treatment effect , -0.2 points ; 95 % CI , -0.8 to 0.4 ; P = 0.48 ) .
RESULTS	A prespecified secondary subgroup analysis with stratification according to type of injection ( interlaminar vs. transforaminal ) likewise showed no significant differences at 6 weeks .
CONCLUSIONS	In the treatment of lumbar spinal stenosis , epidural injection of glucocorticoids plus lidocaine offered minimal or no short-term benefit as compared with epidural injection of lidocaine alone .
CONCLUSIONS	( Funded by the Agency for Healthcare Research and Quality ; ClinicalTrials.gov number , NCT01238536 . )

###24623104
OBJECTIVE	GC1113 , a hybrid Fc-fused erythropoietin , is a novel erythropoiesis-stimulating agent that is expected to have an extended duration of action .
OBJECTIVE	The preclinical data showed that the hemoglobin increase lasted longer following GC1113 administration than it did following the administration of darbepoetin alfa ( NESP ) .
OBJECTIVE	This study aimed to investigate the pharmacodynamic and pharmacokinetic characteristics and tolerability profiles of GC1113 in humans after single intravenous or subcutaneous administration and to compare the results with those for darbepoetin alfa .
METHODS	A dose-block randomized , placebo - and active-controlled , dose-escalation phase I clinical trial was conducted in 96 healthy volunteers .
METHODS	Blood samples were collected before and up to 672 h after drug administration and the serum erythropoietin concentration following the GC1113 or darbepoetin alfa administration was measured by an ELISA .
METHODS	The reticulocyte counts were measured for pharmacodynamic assessments .
METHODS	Pharmacokinetic and pharmacodynamic parameters were determined using non-compartmental methods .
RESULTS	The reticulocyte count-time profiles in the intravenous GC1113 3-5 g/kg groups were comparable with those of the darbepoetin alfa 30 g group .
RESULTS	After subcutaneous administration of GC1113 , reticulocyte count peaked later and decreased more slowly than it did following darbepoetin alfa administration .
RESULTS	GC1113 ( 0.3-5 g/kg intravenous , 1-8 g/kg subcutaneous ) was well-tolerated in the volunteers , and no immunogenicity was observed .
CONCLUSIONS	GC1113 was tolerated and effective in the studied dose range ; these findings could be applied to further clinical studies with patients .

###24670520
OBJECTIVE	To evaluate the efficacy and safety of antiretroviral simplification from a ritonavir-boosted protease inhibitor-based regimen [ protease inhibitor + RTV + two nucleos ( t ) ide reverse transcriptase inhibitors ( NRTIs ) ; 6 months of exposure prior to study entry with no prior treatment failure ] to the single-tablet regimen ( STR ) rilpivirine/emtricitabine/tenofovir disoproxil fumarate ( RPV/FTC/TDF ) in virologically suppressed , HIV-1-infected participants .
METHODS	Phase 3b , randomized , open-label , international , 48-week switch study .
METHODS	Participants were randomized 2:1 to switch to RPV/FTC/TDF immediately or stay on their baseline protease inhibitor + RTV +2 NRTIs regimen with a delayed switch to RPV/FTC/TDF at week 24 .
METHODS	The primary endpoint was noninferiority ( 12 % margin ) of RPV/FTC/TDF compared with protease inhibitor + RTV + two NRTIs in maintaining plasma HIV-1 RNA less than 50copies/ml at week 24 by Snapshot analysis .
RESULTS	A total of 476 participants were randomized and received at least one dose of study drug .
RESULTS	Demographics and baseline characteristics were similar between arms .
RESULTS	The primary objective of noninferiority at week 24 was met : HIV-1 RNA less than 50copies/ml by Snapshot analysis , 93.7 % of RPV/FTC/TDF versus 89.9 % of protease inhibitor + RTV + two NRTIs ( difference 3.8 % , 95 % confidence interval -1.6 to 9.1 % ) .
RESULTS	Through week 48 , 89.3 % of participants in the immediate switch group maintained virologic suppression .
RESULTS	High rates of suppression were maintained with RPV/FTC/TDF regardless of participant 's pre-antiretroviral HIV-1 RNA level .
RESULTS	Overall development of resistance mutations after switching to RPV/FTC/TDF was low .
RESULTS	Decreases in total cholesterol , low-density lipoprotein ( LDL ) , and triglycerides were significantly greater among RPV/FTC/TDF recipients than those in the protease inhibitor + RTV + two NRTIs group .
CONCLUSIONS	Switching to the STR RPV/FTC/TDF from an RTV-boosted protease inhibitor regimen in virologically suppressed , HIV-1-infected participants maintained virologic suppression with a low risk of virologic failure , while improving total cholesterol , LDL , and triglycerides .

###25083759
BACKGROUND	Chronic pain caused by myofascial pain syndrome ( MPS ) results in generalized and debilitating conditions .
BACKGROUND	Trigger-point injection ( TPI ) is the mainstay of MPS management to reduce acute and localized pain .
BACKGROUND	Other adjunctive intervention to modulate the central pain pathway might be helpful if they are combined with TPI .
BACKGROUND	Transcranial direct-current stimulation ( tDCS ) , which is a form of neurostimulation , has been reported to be safe and effective in treating chronic pain by changing cortical excitability .
OBJECTIVE	To determine whether there is an additional effect of tDCS and TPI to reduce pain in patients with MPS .
METHODS	Twenty-one patients with newly diagnosed MPS of shoulder girdle muscles .
METHODS	Patients were randomly assigned into 1 of 3 groups ( 2 active and 1 sham stimulation groups ) and received TPI .
METHODS	Immediately after TPI , tDCS ( 2 mA for 20 minutes on 5 consecutive days ) was administered .
METHODS	For the active stimulation groups , tDCS was applied over 2 different locations ( primary motor cortex and dorsolateral prefrontal cortex [ DLPFC ] ) .
METHODS	Visual analogue scale ( VAS ) , Pain Threshold Test , and short form of the McGill Pain Questionnaire were measured before and immediately after stimulation for 5 consecutive days .
RESULTS	The mean VAS values were decreased in all three groups after 5 days .
RESULTS	There was a significant change between before and after stimulation only in the DLPFC group .
RESULTS	The significant change in the mean VAS value was shown from after the second stimulation session ( p = 0.031 ) , and this remained significant until the last stimulation session ( p = 0.027 ) .
CONCLUSIONS	This study suggests that tDCS over DLPFC may have additional effects with TPI to reduce pain in patients with MPS .
CONCLUSIONS	tDCS over DLPFC can be used to reverse central pain pathway by modulating cortical plasticity .

###24787968
BACKGROUND	Docetaxel or AA are therapeutic options for mCRPC .
BACKGROUND	We retrospectively analyzed clinical outcomes with subsequent docetaxel in patients with mCRPC after disease progression ( DP ) with AA to evaluate cross resistance between these therapies .
METHODS	Patients with chemotherapy-naive mCRPC who were treated with AA in previously reported phase I to III trials , who had DP , and were subsequently treated ( not on study ) with docetaxel , were included .
METHODS	Acquired AA resistance was defined as : PSA decline > 50 % from baseline or radiographically stable disease for 8 months , with subsequent DP .
METHODS	All other patients were defined as having primary AA resistance .
METHODS	Efficacy outcomes after docetaxel therapy were analyzed .
RESULTS	We identified 23 patients who were treated with docetaxel after DP with AA , including 14 ( 61 % ) with acquired and 9 ( 39 % ) with primary AA resistance .
RESULTS	Median duration between discontinuation of AA and docetaxel initiation was 2.7 months ( range , 0.2-14 .7 months ) .
RESULTS	Subsequent docetaxel therapy led to 30 % PSA decline in 15 patients ( 65 % ) and 50 % PSA decline in 11 patients ( 48 % ) .
RESULTS	Median OS from date of first docetaxel dose was 12.4 months ( 95 % confidence interval , 8.2-19 .6 ) .
RESULTS	Patients with previous primary versus acquired AA resistance had similar outcomes with subsequent docetaxel therapy .
CONCLUSIONS	In this retrospective analysis , the type of AA resistance did not appear to affect outcomes with subsequent docetaxel .
CONCLUSIONS	The PSA response rates observed suggest a lack of cross-resistance between docetaxel and AA , but prospective studies are needed to evaluate for potential cross-resistance and optimize sequences of therapy in patients with mCRPC .

###24725237
BACKGROUND	Interferon-containing regimens for the treatment of hepatitis C virus ( HCV ) infection are associated with increased toxic effects in patients who also have cirrhosis .
BACKGROUND	We evaluated the interferon-free combination of the protease inhibitor ABT-450 with ritonavir ( ABT-450 / r ) , the NS5A inhibitor ombitasvir ( ABT-267 ) , the nonnucleoside polymerase inhibitor dasabuvir ( ABT-333 ) , and ribavirin in an open-label phase 3 trial involving previously untreated and previously treated adults with HCV genotype 1 infection and compensated cirrhosis .
METHODS	We randomly assigned 380 patients with Child-Pugh class A cirrhosis to receive either 12 or 24 weeks of treatment with ABT-450 / r-ombitasvir ( at a once-daily dose of 150 mg of ABT-450 , 100 mg of ritonavir , and 25 mg of ombitasvir ) , dasabuvir ( 250 mg twice daily ) , and ribavirin administered according to body weight .
METHODS	The primary efficacy end point was a sustained virologic response 12 weeks after the end of treatment .
METHODS	The rate of sustained virologic response in each group was compared with the estimated rate with a telaprevir-based regimen ( 47 % ; 95 % confidence interval [ CI ] , 41 to 54 ) .
METHODS	A noninferiority margin of 10.5 percentage points established 43 % as the noninferiority threshold ; the superiority threshold was 54 % .
RESULTS	A total of 191 of 208 patients who received 12 weeks of treatment had a sustained virologic response at post-treatment week 12 , for a rate of 91.8 % ( 97.5 % CI , 87.6 to 96.1 ) .
RESULTS	A total of 165 of 172 patients who received 24 weeks of treatment had a sustained virologic response at post-treatment week 12 , for a rate of 95.9 % ( 97.5 % CI , 92.6 to 99.3 ) .
RESULTS	These rates were superior to the historical control rate .
RESULTS	The three most common adverse events were fatigue ( in 32.7 % of patients in the 12-week group and 46.5 % of patients in the 24-week group ) , headache ( in 27.9 % and 30.8 % , respectively ) , and nausea ( in 17.8 % and 20.3 % , respectively ) .
RESULTS	The hemoglobin level was less than 10 g per deciliter in 7.2 % and 11.0 % of patients in the respective groups .
RESULTS	Overall , 2.1 % of patients discontinued treatment owing to adverse events .
CONCLUSIONS	In this phase 3 trial of an oral , interferon-free regimen evaluated exclusively in patients with HCV genotype 1 infection and cirrhosis , multitargeted therapy with the use of three new antiviral agents and ribavirin resulted in high rates of sustained virologic response .
CONCLUSIONS	Drug discontinuations due to adverse events were infrequent .
CONCLUSIONS	( Funded by AbbVie ; TURQUOISE-II ClinicalTrials.gov number , NCT01704755 . )

###24383855
BACKGROUND	The role played by T helper cytokines under chronic , low grade inflammation as seen in type-2 Diabetes Mellitus ( T2DM ) and Coronary Artery Disease ( CAD ) co-morbidity is less well studied .
BACKGROUND	In the present study , we measured the serum levels of both Th1 and Th2 cytokines and correlated it with clinical risk factors for T2DM ( Insulin Resistance ( IR ) , Glycated haemoglobin ( HbA1c ) ) and CAD ( C-Reactive Protein ( CRP ) , Intima Media Thickness ( IMT ) and Augmentation index ( AGI ) ) in T2DM subjects with/without CAD .
METHODS	The study subjects were recruited from Chennai Urban Rural Epidemiology Study ( CURES ) .
METHODS	Serum cytokine profile was determined by multiplex cytokine assay in Control ( n = 61 ) , T2DM ( n = 60 ) , CAD ( n = 23 ) and T2DM-CAD ( n = 21 ) subjects .
RESULTS	T2DM subjects showed a mixed Th1-Th2 profile .
RESULTS	CAD subjects presented a Th1 profile with modest Th2 suppression while T2DM-CAD subjects showed enhanced Th1 profile with strong suppression of Th2 cytokines .
RESULTS	Both Th1 and Th2 cytokines showed a positive correlation with FPG , HbA1c , hsCRP , IMT and AGI .
RESULTS	Logistic regression analysis revealed a significant association of IL-12 ( OR = 9.3 ; 95 % CI = 3.2-70 .7 ; p = 0.016 ) , IFN - ( OR = 2.8 ; 95 % CI = 2.7-2 .9 , p = 0.010 ) , IL-4 ( OR = 2.7 ; 95 % CI 2.7-2 .7 , p = 0.010 ) , IL-5 ( OR = 1.1 ; 95 % CI = 1.0-1 .4 ; p = 0.003 ) and IL-13 ( OR = 2 ; 95 % CI = 1.7-2 .6 ; p = 0.017 ) with T2DM-CAD .
CONCLUSIONS	In conclusion , from the present study it appears that transition from T2DM or CAD to T2DM-CAD co-morbidity is associated with strong down regulation of Th2 cytokines and enhancement of Th1 responses .

###24565386
BACKGROUND	We aimed to investigate the effects of metoclopramide and ondansetrone on mivacurium neuromuscular blockade .
METHODS	Seventy five , ASA I-II patients , aged 18-65 and scheduled for elective surgery requiring tracheal intubation were included in the study .
METHODS	The patients received metoclopramide 10 mg , ondansetrone 4 mg or normal saline 5 mL ; group M , group O , group NS ( n = 25 ) , respectively .
METHODS	Before anesthesia study drugs were administered in a volume of 5 mL .
METHODS	The level of plasma cholinesterase were obtained before and 5 minutes after the administration of study drugs and 5 minutes after the administration of mivacurium .
METHODS	Onset time , T25 , T75 , T25-75 , T90 levels were compared with each other and differences between each patients were investigated .
METHODS	After recording T90 , the study was terminated and surgery was started .
RESULTS	Onset time was significantly shorter in group M , than the other two groups .
RESULTS	Onset time in group O was significantly shorter than in group NS .
RESULTS	In Group M T25 , T75 , T90 and recovery indices were significantly greater than in Group NS ( p < 0.001 ) .
RESULTS	In Group O T25 , T75 were greater than Group NS ( p < 0.01 and p < 0.05 , respectively ) .
RESULTS	In Group M T75 , T90 and emergence indices were significantly higher than Group O ( p < 0.001 , p < 0.01 , p < 0.001 , respectively ) .
RESULTS	In Groups M and O , plasma cholinesterase levels decreased significantly ( p < 0.001 ) after administration of study drugs and mivacurium .
RESULTS	Plasma cholinesterase also was reduced in Group NS 5 minutes after the administration of mivacurium ( p < 0.001 ) .
CONCLUSIONS	Ondansetrone is believed to be more reliable agent than metoclopramide when used with mivacurium .

###24671945
BACKGROUND	Our previous randomized , clinical trial showed that postoperative tight glycemic control ( TGC ) for children undergoing cardiac surgery did not reduce the rate of health care-associated infections compared with standard care ( STD ) .
BACKGROUND	Heterogeneity of treatment effect may exist within this population .
RESULTS	We performed a post hoc exploratory analysis of 980 children from birth to 36 months of age at the time of cardiac surgery who were randomized to postoperative TGC or STD in the intensive care unit .
RESULTS	Significant interactions were observed between treatment group and both neonate ( age 30 days ; P = 0.03 ) and intraoperative glucocorticoid exposure ( P = 0.03 ) on the risk of infection .
RESULTS	The rate and incidence of infections in subjects 60 days old were significantly increased in the TGC compared with the STD group ( rate : 13.5 versus 3.7 infections per 1000 cardiac intensive care unit days , P = 0.01 ; incidence : 13 % versus 4 % , P = 0.02 ) , whereas infections among those > 60 days of age were significantly reduced in the TGC compared with the STD group ( rate : 5.0 versus 14.1 infections per 1000 cardiac intensive care unit days , P = 0.02 ; incidence : 2 % versus 5 % , P = 0.03 ) ; the interaction of treatment group by age subgroup was highly significant ( P = 0.001 ) .
RESULTS	Multivariable logistic regression controlling for the main effects revealed that previous cardiac surgery , chromosomal anomaly , and delayed sternal closure were independently associated with increased risk of infection .
CONCLUSIONS	This exploratory analysis demonstrated that TGC may lower the risk of infection in children > 60 days of age at the time of cardiac surgery compared with children receiving STD .
CONCLUSIONS	Meta-analyses of past and ongoing clinical trials are necessary to confirm these findings before clinical practice is altered .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00443599 .

###25185593
BACKGROUND	Recent studies have shown a decline in glomerular filtration rate and increased renal vasoconstriction after administration of normal saline when compared with IV solutions with less chloride .
BACKGROUND	In this study , we investigated the impact of normal saline versus a chloride-reduced , acetate-buffered crystalloid on the incidence of hyperkalemia during cadaveric renal transplantation .
BACKGROUND	The incidence of metabolic acidosis and kidney function were secondary aims .
METHODS	In this prospective randomized controlled trial , 150 patients received normal saline or an acetate-buffered balanced crystalloid during and after cadaveric renal transplantation .
METHODS	Venous blood gases were obtained at the start of anesthesia and every 30 minutes until discharge from the postoperative surveillance unit .
METHODS	Serum creatinine and 24-hour urine output were obtained on postoperative days 1 , 3 , and 7 .
RESULTS	Patients received a similar amount of fluid ( median : 2625mL [ interquartile range : 2000 to 3100 ] vs 2500 mL [ 2000 to 3050 ] , P = 0.83 ) .
RESULTS	Hyperkalemia , defined as serum potassium > 5.9 mmol/L , occurred in 13 patients ( 17 % ) in the saline and 15 ( 21 % ) in the balanced group ( P = 0.56 ; difference between proportions -0.037 [ -16.5 % to 8.9 % ] ) .
RESULTS	Minimum base excess was lower in the saline group compared with the balanced regimen ( -4.5 mmol/L [ -6 to -2.4 ] vs -2.6 mmol/L [ -4 to -1 ] , P < 0.001 ) and maximum chloride was significantly higher in the saline group ( 109 mmol/L [ 107 to 111 ] vs 107 mmol/L [ 105 to 109 ] , P < 0.001 ) .
RESULTS	No difference in creatinine or urine output was seen postoperatively .
RESULTS	Significantly more patients needed catecholamines in the saline group ( 30 % vs 15 % , P = 0.03 ) .
CONCLUSIONS	The incidence of hyperkalemia differed by less than 17 % between groups .
CONCLUSIONS	Use of balanced crystalloid resulted in less hyperchloremia and metabolic acidosis .
CONCLUSIONS	Significantly more patients in the saline group required administration of catecholamines for circulatory support .

###25234605
OBJECTIVE	To examine changes in intake across food groups during a weight loss trial that produced significant and sustainable weight loss in lactating women receiving dietary treatment .
METHODS	At 10-14 wk postpartum , 61 overweight and obese lactating Swedish women were randomized to a 12-wk dietary ( D ) , exercise ( E ) , combined ( DE ) , or control ( C ) treatment .
METHODS	Food intake was assessed by 4-d weighed diet records which were used to examine changes in intake across seven food groups from baseline to 12 wk and 1 y after randomization .
METHODS	Differences in changes in food choice between women receiving dietary treatment ( D+DE ) and no dietary treatment ( E+C ) were examined using multivariate linear regression .
RESULTS	At baseline , sweets and salty snacks contributed to 2110 percent of total energy intake ( E % ) .
RESULTS	During the intervention period , women receiving dietary treatment reduced their E % from sweets and salty snacks and caloric drinks and increased their E % from vegetables more than did women not receiving dietary treatment ( all P < 0.010 ) .
RESULTS	At 1 y , the increased E % from vegetables was maintained significantly higher among women receiving dietary treatment ( P = 0.002 ) .
CONCLUSIONS	Lactating women receiving dietary treatment achieved sustainable weight loss through changes in food choice in line with current dietary guidelines .

###24890527
BACKGROUND	Suspected coronary artery disease ( CAD ) is one of the most common , potentially life-threatening diagnostic problems clinicians encounter .
BACKGROUND	However , no large outcome-based randomized trials have been performed to guide the selection of diagnostic strategies for these patients .
METHODS	The PROMISE study is a prospective , randomized trial comparing the effectiveness of 2 initial diagnostic strategies in patients with symptoms suspicious for CAD .
METHODS	Patients are randomized to either ( 1 ) functional testing ( exercise electrocardiogram , stress nuclear imaging , or stress echocardiogram ) or ( 2 ) anatomical testing with 64-slice multidetector coronary computed tomographic angiography .
METHODS	Tests are interpreted locally in real time by subspecialty certified physicians , and all subsequent care decisions are made by the clinical care team .
METHODS	Sites are provided results of central core laboratory quality and completeness assessment .
METHODS	All subjects are followed up for 1 year .
METHODS	The primary end point is the time to occurrence of the composite of death , myocardial infarction , major procedural complications ( stroke , major bleeding , anaphylaxis , and renal failure ) , or hospitalization for unstable angina .
RESULTS	More than 10,000 symptomatic subjects were randomized in 3.2 years at 193 US and Canadian cardiology , radiology , primary care , urgent care , and anesthesiology sites .
CONCLUSIONS	Multispecialty community practice enrollment into a large pragmatic trial of diagnostic testing strategies is both feasible and efficient .
CONCLUSIONS	The PROMISE trial will compare the clinical effectiveness of an initial strategy of functional testing against an initial strategy of anatomical testing in symptomatic patients with suspected CAD .
CONCLUSIONS	Quality of life , resource use , cost-effectiveness , and radiation exposure will be assessed .

###24965902
BACKGROUND	Tolvaptan is a selective vasopressin receptor antagonist ( V2R ) that increases free water excretion .
BACKGROUND	We wanted to test the hypotheses that tolvaptan changes both renal handling of water and sodium and systemic hemodynamics during basal conditions and during nitric oxide ( NO ) - inhibition with L-NG-monomethyl-arginine ( L-NMMA ) .
METHODS	Nineteen healthy subjects were enrolled in a randomized , placebo-controlled , double-blind , crossover study of two examination days .
METHODS	Tolvaptan 15 mg or placebo was given in the morning .
METHODS	L-NMMA was given as a bolus followed by continuous infusion during 60 minutes .
METHODS	We measured urine output ( UO ) , free water clearance ( CH2O ) , fractional excretion of sodium ( FENa ) , urinary aquaporin-2 channels ( u-AQP2 ) and epithelial sodium channels ( u-ENaC ) , plasma vasopressin ( p-AVP ) , central and brachial blood pressure ( cBP , bBP ) .
RESULTS	During baseline conditions , tolvaptan caused a significant increase in UO , CH2O and p-AVP , and FENa was unchanged .
RESULTS	During L-NMMA infusion , UO and CH2O decreased more pronounced after tolvaptan than after placebo ( -54 vs.-42 % and -34 vs.-9 % respectively ) .
RESULTS	U-AQP2 decreased during both treatments , whereas u-ENaC decreased after placebo and increased after tolvaptan .
RESULTS	CBP and bBP were unchanged .
CONCLUSIONS	During baseline conditions , tolvaptan increased renal water excretion .
CONCLUSIONS	During NO-inhibition , the more pronounced reduction in renal water excretion after tolvaptan indicates that NO promotes water excretion in the principal cells , at least partly , via an AVP-dependent mechanism .
CONCLUSIONS	The lack of decrease in u-AQP2 by tolvaptan could be explained by a counteracting effect of increased plasma vasopressin .
CONCLUSIONS	The antagonizing effect of NO-inhibition on u-ENaC suggests that NO interferes with the transport via ENaC by an AVP-dependent mechanism .

###26187227
OBJECTIVE	To assess whether shared medical appointments ( SMAs ) for neuromuscular patients represent a way of using clinicians ' time efficiently without compromising quality of care for patients .
METHODS	Patients with a chronic neuromuscular disease ( NMD ) ( n = 272 ) were randomly allocated to either an SMA or a regular individual annual appointment and followed up for a period of 6 months .
METHODS	Data on resource utilization and quality of life ( EQ-5D ) were collected prospectively , using a health care perspective .
METHODS	Incremental costs and changes in quality-adjusted life-years ( QALYs ) were computed using a probabilistic decision model .
METHODS	Factors critical to the incremental cost-effectiveness of SMAs were explored in sensitivity analyses .
RESULTS	No substantial differences between SMAs and individual visits in terms of costs per QALY were found ( incremental cost-effectiveness ratio -960.00 ; 95 % confidence interval -34,600.00 , +36,800.00 ) .
RESULTS	Sensitivity analyses showed that the cost-effectiveness ratio was particularly sensitive to SMA group size and proportion of patients seeing their treating neurologist .
CONCLUSIONS	Cost-effectiveness of SMAs did not show a significant difference vs that of individual appointments based on data from our randomized controlled trial .
CONCLUSIONS	On the other hand , we were able to show that a minimum of 6 patients per SMA and 75 % of patients attending their treating neurologist are specific conditions under which SMAs qualify as a cost-effective alternative .
CONCLUSIONS	This implies that SMAs may be a means to increase productivity of the physician without compromising quality of care .
METHODS	This study provides Class III evidence that SMAs are not significantly more cost-effective than individual appointments for patients with NMDs .
METHODS	The study lacks the precision to exclude important differences in cost-effectiveness between SMAs and individual appointments .

###25223266
BACKGROUND	Non-adjuvanted seasonal influenza vaccines show only modest efficacy in young children .
BACKGROUND	This study compared the immunogenicity , reactogenicity and safety of the MF59-adjuvanted trivalent subunit vaccine ( aTIV ) with two non-adjuvanted trivalent vaccines , TIV-1 , the non-adjuvanted version of aTIV , and TIV-2 , a split virion vaccine .
METHODS	6078 children received two doses of aTIV ( n = 3125 ) , TIV-1 ( n = 1479 ) , or TIV-2 ( n = 1474 ) four weeks apart ( Days 1 and 29 ) .
METHODS	Children aged 6 to < 36 months and 36 to < 72 months received 0.25 mL and 0.50 mL doses , respectively .
METHODS	Immunogenicity was assessed by hemagglutination inhibition ( HI ) assay ( n = 2435 ) on Days 1 , 29 , 50 and 209 .
METHODS	Safety was assessed up to Day 394 .
RESULTS	After the second vaccination ( Day 50 ) , the aTIV group showed significantly higher geometric mean HI titers and seroconversion rates than the TIV-1 or TIV-2 groups against all homologous and heterologous strains .
RESULTS	The difference was enhanced at HI titers 110 .
RESULTS	aTIV elicited a faster , more persistent antibody response , with significantly higher titers in the aTIV group after one vaccination ( Day 29 ) and after six months ( Day 209 ) than in either TIV group .
RESULTS	aTIV was more reactogenic than were TIV-1 and TIV-2 but rates of severe adverse events were very low for all three vaccines .
CONCLUSIONS	In infants and young children , the MF59-adjuvanted vaccine induced substantially faster ( after one dose ) , higher , persistent HI titers than the non-adjuvanted vaccines , with consistently higher seroprotection rates at increased threshold HI titers .
CONCLUSIONS	This trial is registered at clinicaltrials.gov : NCT01346592 .

###24731672
BACKGROUND	When patients with type 2 diabetes start their first injectable therapy , clinicians can choose between glucagon-like peptide-1 ( GLP-1 ) receptor agonists and basal insulins .
BACKGROUND	In DURATION-3 , exenatide once weekly was compared with insulin glargine ( henceforth , glargine ) as first injectable therapy .
BACKGROUND	Here , we report the results of the final 3-year follow-up .
METHODS	DURATION-3 was an open-label randomised trial done between May 13 , 2008 , and Jan 30 , 2012 .
METHODS	Patients with type 2 diabetes aged 18 years or older were enrolled at 72 sites worldwide .
METHODS	They were eligible when they had suboptimum glycaemic control ( HbA1c 7.1-11 .0 % [ 54-97 mmol/mol ] ) despite maximum tolerated doses of metformin alone or with a sulfonylurea for at least 3 months , a stable bodyweight for at least 3 months , and a BMI of 25-45 kg/m ( 2 ) ( 23-45 kg/m ( 2 ) in South Korea and Taiwan ) .
METHODS	Patients were randomly assigned ( 1:1 ) by computer-generated random sequence with an interactive voice-response system ( block size four , stratified by country and concomitant therapy ) to once-weekly exenatide ( 2 mg subcutaneous injection ) or once-daily glargine ( titrated to target ) to be given in addition to their existing oral glucose-lowering regimens .
METHODS	The primary efficacy measure at 3 years was change in HbA1c from baseline in patients given at least one dose of the assigned drug ( ie , analyses by modified intention to treat ) .
METHODS	Patients , investigators , and data analysts were not masked to treatment assignment .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00641056 .
RESULTS	456 patients underwent randomisation and received at least one dose of the assigned drug ( 233 given exenatide , 223 glargine ) .
RESULTS	At 3 years , least-squares mean HbA1c change was -1.01 % ( SE 0.07 ) in the exenatide group versus -0.81 % ( 0.07 ) in the glargine group ( least-squares mean difference -0.20 % , SE 0.10 , 95 % CI -0.39 to -0.02 ; p = 0.03 ) .
RESULTS	Transient gastrointestinal adverse events characteristic of GLP-1 receptor agonists were more frequent with exenatide than glargine ( nausea : 36 [ 15 % ] of 233 patients vs five [ 2 % ] of 223 ; vomiting : 15 [ 6 % ] vs six [ 3 % ] ; diarrhoea : 32 [ 14 % ] vs 15 [ 7 % ] ) , although frequency of these events did decrease after week 26 in the exenatide group .
RESULTS	The proportion of patients who reported serious adverse events in the exenatide group ( 36 patients [ 15 % ] ) was the same as that in the glargine group ( 33 [ 15 % ] ) .
RESULTS	The exposure-adjusted rate of overall hypoglycaemia was three times higher in patients given glargine ( 0.9 events per patient per year ) than in those given exenatide ( 0.3 events per patient per year ) .
CONCLUSIONS	Efficacy of once-weekly exenatide is sustained for 3 years .
CONCLUSIONS	GLP-1 receptor agonists could be a viable long-term injectable treatment option in patients with type 2 diabetes who have not yet started taking insulin .
BACKGROUND	Amylin Pharmaceuticals and Eli Lilly .

###24439981
BACKGROUND	In the major trials of cardiac resynchronization therapy ( CRT ) , the survival benefit of the therapy , relative to control subjects , increases with QRS duration .
BACKGROUND	In the non-CRT heart failure population , however , a wide QRS duration is associated with a shorter survival .
BACKGROUND	Relative survival benefit from a therapy , however , is not synonymous with a longer absolute survival .
BACKGROUND	We sought to determine whether baseline QRS duration relates to the absolute survival after CRT .
RESULTS	In this prospective , longitudinal , observational study , 3,319 consecutive patients undergoing CRT ( QRS 120-149 ms 26 % , QRS 150-199 ms 58 % , and QRS 200 ms 16 % ) were assessed in relation to mortality over 10 years .
RESULTS	Overall mortality rates ( per 100 patient-years ) were 9.2 % , 9.3 % , and 13.3 % in the 3 groups , respectively ( all P < .001 ) .
RESULTS	Cardiac mortality rates were 6.2 , 6.0 , and 9.9 per 100 patient-years , respectively ( all P < .001 ) .
RESULTS	Compared with the QRS 120-149 ms group , cardiac mortality was highest in the QRS 200 ms group ( hazard ratio [ HR ] 1.72 [ 95 % CI 1.35-2 .19 ] , P < .001 ) , independent of age , gender , New York Heart Association class , presence of atrial fibrillation , heart failure etiology , and left ventricular ejection fraction .
RESULTS	Median survival after CRT was longest in patients with a width of QRS 120-149 ms and shortest in patients with a QRS 200 ms ( P < .001 ) .
RESULTS	In multivariable analyses , a QRS 200 ms emerged as a powerful independent predictor of both overall ( HR 1.44 [ 95 % CI 1.07-1 .94 ] , P = .017 ) and cardiac mortality ( HR 1.59 [ 95 % CI 1.14-2 .24 ] , P = .007 ) .
CONCLUSIONS	At long-term follow-up , absolute overall and cardiac survival after CRT is similar in patients with a preimplant QRS duration of 120 to 149 ms and 150 to 199 ms but markedly shorter in patients with a QRS 200 ms.

###25022113
OBJECTIVE	To compare the clinical efficacy in the treatment of allergic rhinitis ( AR ) of lung qi deficiency and cold syndrome between Jin 's three-needle therapy and western medication .
METHODS	Sixty-six patients were randomized into an acupuncture group and a western medication group , 33 cases in each one .
METHODS	In the acupuncture group , acupuncture was applied at three-nose points [ Yingxiang ( LI 20 ) , Shangyingxiang ( EX-HN 8 ) and Yintang ( GV 29 ) ; Cuanzhu ( BL 2 ) was added for frontal headache ] and three-back points [ Dazhu ( BL 11 ) , Fengmen ( BL 12 ) and Feishu ( BL 13 ) ] , once every day .
METHODS	Ten treatments made one session .
METHODS	Two sessions of treatment were required .
METHODS	In the western medication group , desloratadine oral suspension was prescribed , 5 mg each time , once a day , for 20 days .
METHODS	The scores of the symptoms and physical signs in AR patients as well as the clinical efficacy were observed between the two groups .
RESULTS	The total effective rate was 93.9 % ( 31/33 ) in the acupuncture group , which was better than 72.7 % ( 24/33 ) in the western medication group ( P < 0.05 ) .
RESULTS	After treatment , the scores of AR symptoms and physical signs as well as the total score were all reduced compared with those before treatment in the two groups ( all P < 0.01 ) .
RESULTS	The score of every item in the acupuncture group was lower than that in the western medication group after treatment ( score of symptoms : 4.70 + / - 2.07 vs 6.55 + / - 2.69 , score of physical signs : 0.85 + / - 0.67 vs 1.45 + / - +0.62 , total score : 5.36 + / - 2.70 vs 8.00 + / - 2.91 , all P < 0.01 ) .
CONCLUSIONS	Jin 's three-needle therapy achieves superior efficacy on AR of lung-qi deficiency and cold syndrome , which is better than desloratadine oral suspension .

###25139257
OBJECTIVE	To assess the efficacy of a psychoeducational intervention , Wide Awake Parenting ( WAP ) , to decrease symptoms of postnatal fatigue .
METHODS	A randomized controlled trial .
METHODS	Local government areas within the Australian state of Victoria .
METHODS	Two hundred and two mothers were randomly allocated to either the professionally-led telephone support intervention ( n = 63 ) , self-directed written intervention ( n = 67 ) , or waitlist control ( n = 72 ) .
METHODS	The professionally-led group received a workbook , home visit , and three telephone support calls .
METHODS	The self-directed written group received the workbook only , and the control group received usual health care services .
METHODS	Primary outcomes were symptoms of fatigue , depression , anxiety and stress , and health care beliefs and behaviors .
METHODS	Mothers were followed up at 2 - and 6-weeks postintervention .
RESULTS	Mothers in the professionally-led group reported fewer symptoms of fatigue than mothers in the control condition at 6 weeks postintervention .
RESULTS	Mothers in either intervention had more positive attitudes toward their health - and self-care behaviors at postintervention and follow-up .
RESULTS	Mothers in the professionally-led intervention reported fewer symptoms of depression , anxiety , and stress than mothers in the other conditions at postintervention .
CONCLUSIONS	Wide Awake Parenting is effective in promoting mothers ' self-efficacy to prioritize , plan for , and engage in health and self-care behaviors to promote mental health and manage fatigue .
CONCLUSIONS	Implications and future opportunities for WAP are discussed .

###24555723
BACKGROUND	Filgrastim or methionyl-granulocyte colony-stimulating factor ( Met-G-CSF ) , is a recombinant therapeutic protein widely used to treat severe neutropenia caused by myelosuppressive drugs in patients with nonmyeloid malignancies .
BACKGROUND	In addition to its role in the regulation of granulopoiesis , treatment with G-CSF is considered the standard approach to mobilize CD34 positive ( CD34 + ) mononuclear cells for reconstituting hemopoietic ability for bone marrow transplantation .
BACKGROUND	An intended biosimilar filgrastim ( coded BK0023 ) was produced in GMP conditions by E.coli fermentation according to an original recombinant process and showed physico-chemical properties and purity profile similar to Neupogen , a commercial preparation of filgrastim .
BACKGROUND	The aim of the present study was to demonstrate the comparability of BK0023 to Neupogen in terms of both in vitro biological activities and in vivo toxicology , pharmacokinetics and pharmacodynamics .
METHODS	Cell proliferation and radioligand binding assays were conducted in NFS-60 cells to compare the biological activity and functional interaction with the G-CSF receptor in vitro , while preclinical in vivo studies , including pharmacokinetics and pharmacodynamics after repeated dose were performed in normal and neutropenic rats .
METHODS	A phase I study was carried out in healthy male volunteers treated by multiple-dose subcutaneous administration of BK0023 and Neupogen to evaluate their pharmacodynamic effects as well as their pharmacokinetic and safety profile and to demonstrate their pharmacodynamic equivalence and pharmacokinetic bioequivalence .
RESULTS	The results reported in this work demonstrate that BK0023 is comparable in terms of biological activity , efficacy and safety to Neupogen .
CONCLUSIONS	BK0023 has the same pharmacokinetic profile , efficacy and safety as the reference commercial filgrastim Neupogen and therefore could be further developed to become a convenient option to treat neutropenia in oncological patients .

###25010237
BACKGROUND	Healthcare technologies and patient care have evolved rapidly .
BACKGROUND	Healthcare communication techniques and technologies have lagged .
OBJECTIVE	This pilot study was conducted at Duke University Hospital to investigate the benefits of using smartphones among healthcare team members to promote efficient and effective patient care .
METHODS	This study used a pre-post implementation survey with an educational intervention .
METHODS	Teams ( physicians , patient resource managers , physician assistants , and nurses ) from medicine and surgery were randomly assigned a smartphone .
METHODS	A validated 28-question survey was used to assess user experience ( 7-point Likert scale , with 7 indicating more reliable , strongly agree , and faster ) .
METHODS	Participants were encouraged to attend focus groups to provide feedback on survey content and overall experience .
METHODS	Facilitators used guiding questions and transcripts were used for qualitative analysis .
RESULTS	Eighty-nine matched pre - and postsurveys were analyzed .
RESULTS	Postimplementation data results declined for a majority of items , although remained favorable .
RESULTS	This suggests the reality of smartphone use did not live up to expectations but was still considered an improvement over the current paging system .
RESULTS	Differences by device and user were found , such as the iPhone being easier to use and the BlackBerry more professional ; nonphysicians were more concerned about training and the sterility of the device .
RESULTS	Themes elicited from focus groups included challenges of the current paging system , text message content , device ease of use and utility , service coverage , and professionalism .
CONCLUSIONS	Participants in this study recognized the benefit of using smartphones to reach team members in a timely and convenient manner while having access to beneficial applications .
CONCLUSIONS	Lessons were learned for future implementations with more favorable experiences for participants .
CONCLUSIONS	Perhaps most striking was the shared acknowledgment that the current system does n't work well and an understanding of why .

###24354675
BACKGROUND	Cold hypersensitivity in the hands and feet ( CHHF ) is one of the most common complaints among Asians , especially in women .
BACKGROUND	Korean red ginseng ( KRG ) , which is a steamed form of Panax ginseng , has vasodilating action in the peripheral vessels and increases blood flow under cold stress .
BACKGROUND	However , few studies have evaluated the effect of KRG on cold hypersensitivity .
METHODS	This trial is a randomized , double-blind , placebo-controlled trial in 80 CHHF patients .
METHODS	The trial will be implemented at Kyung Hee University Hospital at Gangdong in Seoul , Korea .
METHODS	The participants will take KRG or a placebo for eight weeks , after which they will be followed-up for four weeks .
METHODS	During the administration period , six capsules of 500 mg KRG or placebo will be provided twice a day .
METHODS	The primary outcome is change of skin temperature in the hands between baseline and after treatment .
METHODS	The secondary outcomes include the visual analogue scale scores of cold hypersensitivity in the hands , change of skin temperature and the VAS scores of cold hypersensitivity in the feet , the recovery rate of the skin temperature by the cold stress test of the hands , the distal-dorsal difference of the hands , power variables of heart rate variability , and the 36-item short form health survey .
CONCLUSIONS	This study is the first trial to evaluate the efficacy of KRG on CHHF by using infrared thermography .
CONCLUSIONS	Our study will provide basic evidence regarding CHHF .
BACKGROUND	CliniacalTrials.gov NCT01664156 .

###25210879
BACKGROUND	Studies relating to the cardiovascular effects of glucagon-like peptide-1 ( GLP-1 ) and its agonists , which slow gastric emptying , have not discriminated between fasting and postprandial , blood pressure ( BP ) and heart rate ( HR ) .
OBJECTIVE	To determine whether exogenous GLP-1 modulates the effects of an intraduodenal ( ID ) glucose infusion on BP , HR , and splanchnic blood flow in healthy older subjects .
METHODS	A double-blind randomized trial was conducted .
METHODS	Community-dwelling residents attended a clinical research laboratory .
METHODS	Ten healthy `` older '' subjects ( 9 male , 1 female ; age 73.2 1.5 y ) were studied .
METHODS	Intravenous infusion of GLP-1 ( 0.9 pmol/kg/min ) , or saline ( 0.9 % ) for 90 min ( t = -30 -60 min ) .
METHODS	Between t = 0-60 min , ID glucose was infused at 3 kcal/min .
METHODS	BP , HR , superior mesenteric artery ( SMA ) flow , blood glucose , and serum insulin were measured .
RESULTS	During the fasting period ( t = -30 -0 min ) , GLP-1 had no effect on BP or HR .
RESULTS	In response to ID glucose ( t = 0-60 min ) , systolic BP decreased ( P < .001 ) , and both HR ( P < .001 ) and SMA flow ( P < .05 ) increased , on both days .
RESULTS	GLP-1 attenuated the maximum decrease in systolic BP ( P < .05 ) , tended to increase HR ( P = .09 ) , and increased SMA flow ( P < .01 ) .
RESULTS	GLP-1 diminished the glycemic response ( P < .05 ) .
CONCLUSIONS	In healthy older subjects , acute administration of GLP-1 attenuates the hypotensive response to ID glucose , and potentiates the increase in SMA flow .

###24745197
OBJECTIVE	The objective of the paper is to understand leadership in an online community , specifically , Wikipedia .
BACKGROUND	Wikipedia successfully aggregates millions of volunteers ' efforts to create the largest encyclopedia in human history .
BACKGROUND	Without formal employment contracts and monetary incentives , one significant question for Wikipedia is how it organizes individual members with differing goals , experience , and commitment to achieve a collective outcome .
BACKGROUND	Rather than focusing on the role of the small set of people occupying a core leadership position , we propose a shared leadership model to explain the leadership in Wikipedia .
BACKGROUND	Members mutually influence one another by exercising leadership behaviors , including rewarding , regulating , directing , and socializing one another .
METHODS	We conducted a two-phase study to investigate how distinct types of leadership behaviors ( transactional , aversive , directive , and person-focused ) , the legitimacy of the people who deliver the leadership , and the experience of the people who receive the leadership influence the effectiveness of shared leadership in Wikipedia .
RESULTS	Our results highlight the importance of shared leadership in Wikipedia and identify trade-offs in the effectiveness of different types of leadership behaviors .
RESULTS	Aversive and directive leadership increased contribution to the focal task , whereas transactional and person-focused leadership increased general motivation .
RESULTS	We also found important differences in how newcomers and experienced members responded to leadership behaviors from peers .
CONCLUSIONS	These findings extend shared leadership theories , contribute new insight into the important underlying mechanisms in Wikipedia , and have implications for practitioners who wish to design more effective and successful online communities .

###24694358
OBJECTIVE	The study objective was to assess the effectiveness of a turmeric - and sandal wood oil-containing cream [ Vicco ( ) turmeric cream ( VTC ) ; Vicco Laboratories , Parel , India ] on radiodermatitis in patients with head and neck cancer undergoing radiotherapy .
METHODS	A total of 50 patients with head and neck cancer requiring > 60 Gy of curative radiotherapy/chemoradiotherapy were enrolled in the study .
METHODS	The volunteers were randomly divided into two groups of 25 patients .
METHODS	Group 1 was assigned to a topical application of Johnson 's ( ) baby oil ( Johnson & Johnson Ltd , Baddi , India ) and Group 2 for VTC .
METHODS	Prophylactic application of the cream was initiated on Day 1 and continued every day until 2 weeks after the end of treatment .
METHODS	Both agents were symmetrically applied within the irradiated field five times a day , and the acute skin reactions were assessed twice weekly in accordance with the Radiation Therapy Oncology Group scores by an investigator who was unaware of the details .
RESULTS	The incidence of radiodermatitis increased with the exposure to radiation and was the highest in both groups at Week 7 .
RESULTS	However , a significant reduction in grades of dermatitis were seen in cohorts applying VTC at all time points , including 2 weeks post radiotherapy ( p < 0.015 to p < 0.001 ) .
RESULTS	The occurrence of Grade 3 dermatitis was lower in the cohorts using VTC and was statistically significant ( p < 0.01 ) .
RESULTS	Additionally , follow-up observations 2 weeks after the completion of radiotherapy also showed a reduced degree of radiodermatitis in cohorts applying VTC , which was significant ( p = 0.015 ) .
CONCLUSIONS	VTC is shown to be effective in preventing radiodermatitis and needs to be validated in larger double-blind trials .
CONCLUSIONS	For the first time , this study shows that the turmeric - and sandal oil-based cream was effective in preventing radiation-induced dermatitis .

###24703574
BACKGROUND	Pemetrexed and erlotinib have been approved as second-line monotherapy for locally advanced or metastatic non-small cell lung cancer ( NSCLC ) .
BACKGROUND	This multicentre , randomised , open-label , parallel phase II study assessed efficacy and safety of pemetrexed versus pemetrexed + erlotinib in patients with advanced non-squamous NSCLC .
METHODS	NSCLC stage III-IV patients who failed one prior platinum-based chemotherapy regimen , 1 measurable lesion by Response Evaluation Criteria in Solid Tumors , and Eastern Cooperative Oncology Group performance status 2 were eligible .
METHODS	Patients received pemetrexed 500 mg/m ( 2 ) with vitamin B12 and folic acid q3w alone or combined with erlotinib 150 mg daily .
METHODS	The primary end-point was progression-free survival ( PFS ) .
METHODS	Secondary end-points were overall survival ( OS ) , time-to-treatment failure ( TTTF ) , response and toxicity .
RESULTS	Of 165 randomised non-squamous patients , 159 were treated ( pemetrexed : 83 ; pemetrexed + erlotinib : 76 ) .
RESULTS	The median PFS ( months ; 95 % CI ) was 2.89 ( 1.94 , 3.38 ) for pemetrexed versus 3.19 ( 2.86 , 4.70 ) for pemetrexed + erlotinib ( hazard ratio [ HR ] 0.63 ; 95 % CI : ( 0.44 , 0.90 ) ; P = 0.0047 ) .
RESULTS	The median OS ( months ; 95 % CI ) was 7.75 ( 5.29 , 10.41 ) for pemetrexed versus 11.83 ( 8.18 , 16.66 ) for pemetrexed + erlotinib ( HR : 0.68 ; 95 % CI : 0.46 , 0.98 ; P = 0.019 ) .
RESULTS	The median TTTF ( months : 95 % CI ) was 2.4 ( 1.74 , 2.99 ) for pemetrexed versus 3.0 ( 2.23 , 4.07 ) for pemetrexed + erlotinib ( HR 0.64 ; 95 % CI : 0.46 , 0.89 ; P = 0.0034 ) .
RESULTS	One patient died in pemetrexed + erlotinib arm due to febrile neutropenia .
RESULTS	Grades 3/4 drug-related toxicities ( in 5 % of patients ) in pemetrexed/pemetrexed + erlotinib were febrile neutropenia ( 2.4 % / 10.5 % ) , diarrhoea ( 1.2 % / 5.3 % ) , rash ( 1.2 % / 9.2 % ) ; anaemia ( 6 % / 11.8 % ) , leukopenia ( 9.6 % / 23.7 % ) , neutropenia ( 9.6 % / 25.0 % ) , and thrombocytopenia ( 4.8 % / 14.5 % ) .
CONCLUSIONS	Pemetrexed + erlotinib treatment significantly improved PFS , OS and TTTF in 2nd line non-squamous NSCLC and was associated with an increase in grade 3/4 toxicities compared with pemetrexed alone .

###24953578
OBJECTIVE	To determine the efficacy of oral zinc for treatment of idiopathic neonatal hyperbilirubinemia in near-term and term ( 35-41 weeks ) neonates .
METHODS	Randomized placebo-controlled trial .
METHODS	Tertiary-care teaching hospital .
METHODS	Eighty newborns with idiopathic neonatal hyperbilirubinemia .
METHODS	Neonates were randomized to receive either oral zinc sulfate ( 10 mg/d ) or placebo for 7 days .
METHODS	Primary : total serum bilirubin levels at 48 ( 12 ) h , 96 ( 12 ) h and 144 ( 12 ) h after intervention .
METHODS	Secondary : duration of phototherapy , and serum zinc and copper levels .
RESULTS	Baseline mean ( SD ) total serum bilirubin levels were 14.8 ( 3.8 ) and 14.4 ( 3.5 ) mg/dL in zinc and placebo groups , respectively .
RESULTS	No significant differences were observed in total bilirubin levels between the two groups after the intervention .
RESULTS	Mean ( SD ) total serum bilirubin levels in zinc and placebo groups were 13.9 ( 2.5 ) vs. 13.4 ( 1.9 ) mg/dL ( mean difference 0.566 ; 95 % CI -0.535 , 1.668 , P = 0.038 ) at 48 h , 13.1 ( 2.7 ) vs. 12.8 ( 2.3 ) mg/dL ( mean difference 0.234 ; 95 % CI -1.011 , 1.479 , P = 0.708 ) at 96 h and 8.0 ( 2.0 ) vs. 8.6 ( 1.2 ) mg/dL ( mean difference -0.569 , 95 % CI -1.382 , 0.242 , P = 0.166 ) at 144 h. Although the mean duration of phototherapy in the zinc group was less by 21.3 h ( 95 % CI 11.6 , 30.9 , P = 0.052 ) , the difference was not significant .
RESULTS	Post-intervention , serum zinc levels were significantly higher in the zinc-supplemented group while serum copper levels were comparable between the two groups .
CONCLUSIONS	Oral zinc sulfate , in a dose of 10 mg/day , is not effective in the management of idiopathic neonatal hyperbilirubinemia .

###25498742
BACKGROUND	Enteral nutrition is one of the major risk factors for ventilator-associated pneumonia .
BACKGROUND	Abdominal massage is assumed to prevent the development of ventilator-associated pneumonia by reducing residual gastric volume .
OBJECTIVE	To identify the effect of abdominal massage administered to critically ill patients with mechanical ventilation and continuous enteral feeding on the development of ventilator-associated pneumonia .
METHODS	A randomized controlled design was used in this study .
METHODS	This study was performed in a critical care unit of a university hospital in Turkey .
METHODS	The sample of the study consisted of a total of 32 patients , selected randomly to receive abdominal massage ( n = 16 ) and a control group ( n = 16 ) .
METHODS	The stratified randomization was used in this study .
METHODS	Patients were stratified according to age and gender .
METHODS	A fifteen-minute abdominal massage was administered to the patients in the intervention group twice daily .
METHODS	No intervention was administered to the patients in the control group .
RESULTS	At the end of monitoring days a reduction , compared to the control patients , was identified .
RESULTS	The amount of gastric residual volume and abdominal circumference measurement of the patients in the intervention group had decreased .
RESULTS	This reduction was found to be significant in the statistical analysis ( p < 0.05 ) .
RESULTS	Also , although not reaching the statistical significance level , ventilator-associated pneumonia decreased in the intervention group with a ratio of 6.3 % compared to the control group ( 31.3 % ) ( p > 0.05 ) .
CONCLUSIONS	This study revealed that abdominal massage administered to intubated and enterally fed patients reduced gastric residual volume and abdominal distension .
CONCLUSIONS	In addition , a decrease in the ratio of ventilator-associated pneumonia was determined .

###24285618
OBJECTIVE	To study the effect of case management on quality of life , caregiver strain , and perceived quality of care ( QOC ) in patients with amyotrophic lateral sclerosis ( ALS ) and their caregivers .
METHODS	We conducted a multicenter cluster randomized controlled trial with the multidisciplinary ALS care team as the unit of randomization .
METHODS	During 12 months , patients with ALS and their caregivers received case management plus usual care or usual care alone .
METHODS	Outcome measures were the 40-item ALS Assessment Questionnaire ( ALSAQ-40 ) , Emotional Functioning domain ( EF ) ; the Caregiver Strain Index ( CSI ) ; and the QOC score .
METHODS	These measures were assessed at baseline and at 4 , 8 , and 12 months .
RESULTS	Case management resulted in no changes in ALSAQ-40 EF , CSI , or QOC from baseline to 12 months .
RESULTS	ALSAQ-40 EF scores in both groups were similar at baseline and did not change over time ( p = 0.331 ) .
RESULTS	CSI scores in both groups increased significantly ( p < 0.0001 ) .
RESULTS	Patients with ALS from both groups rated their perceived QOC at baseline with a median score of 8 , which did not change significantly during follow-up .
CONCLUSIONS	Within the context of multidisciplinary ALS care teams , case management appears to confer no benefit for patients with ALS or their caregivers .
METHODS	This study provides Class III evidence that case management in addition to multidisciplinary ALS care does not significantly improve health-related quality of life of patients with ALS .

###24632572
BACKGROUND	Supraglottic airway devices such as the LMA-Supreme ( LMA-S ) and I-gel , which have an additional lumen for the insertion of a gastric tube , can be useful in the management of the difficult airway .
OBJECTIVE	To test the performance of these two devices in the difficult paediatric airway .
METHODS	Randomised double-blind study .
METHODS	Anaesthesia department , university hospital .
METHODS	Sixty American Society of Anesthesiologists ( ASA ) I-II children undergoing elective surgery .
METHODS	After obtaining ethical approval and written informed consent from the parents , we compared the size 2 LMA-S with the I-gel in a simulated airway scenario made more difficult by using a cervical collar to limit mouth opening and neck movement .
METHODS	The primary aim was to compare the oropharyngeal leak pressure of the LMA-S and the I-gel .
METHODS	The secondary aims were to compare success rate , insertion time , time to pass a gastric tube and fibreoptic view of the larynx .
RESULTS	Oropharyngeal leak pressure ( meanSD ) for the LMA-S was significantly higher than with the I-gel ( 20.93.2 versus 18.93.2 cmH2O , P = 0.019 ) .
RESULTS	First attempt success rate for the LMA-S was 100 and 90 % for the I-gel ( P > 0.05 ) .
RESULTS	Insertion time of the LMA-S was shorter than I-gel ( 11.21.8 versus 13.52.4 s , P = 0.001 ) .
RESULTS	Gastric tube placement was possible in all patients .
RESULTS	The mean insertion time of the gastric tube was shorter with the LMA-S than with the I-gel ( 10.33.6 versus 12.73.2 s , P = 0.009 ) .
RESULTS	Fibreoptic laryngeal views were similar in both groups .
CONCLUSIONS	In the simulated difficult airway in children , both airway devices provided effective ventilation .
CONCLUSIONS	Paediatric size 2 LMA-S sustained a higher airway pressure before leaking and was quicker to insert than the I-gel equivalent .
CONCLUSIONS	These differences may not be clinically significant .

###24372884
BACKGROUND	Little evidence exists for the effectiveness of therapy for children with receptive language difficulties , particularly those whose difficulties are severe and persistent .
OBJECTIVE	To establish the effectiveness of explicit speech and language therapy with visual support for secondary school-aged children with language impairments focusing on comprehension of coordinating conjunctions in a randomized control trial with an assessor blind to group status .
METHODS	Fourteen participants ( aged 11 ; 3-16 ; 1 ) with severe RELI ( mean standard scores : CELF4 ELS = 48 , CELF4 RLS = 53 and TROG-2 = 57 ) , but higher non-verbal ( Matrices = 83 ) and visual perceptual skills ( Test of Visual Perceptual Skills ( TVPS ) = 86 ) were randomly assigned to two groups : therapy versus waiting controls .
METHODS	In Phase 1 , the therapy group received eight 30-min individual sessions of explicit teaching with visual support ( Shape Coding ) with their usual SLT .
METHODS	In Phase 2 , the waiting controls received the same therapy .
METHODS	The participants ' comprehension was tested pre - , post-Phase 1 and post-Phase 2 therapy on ( 1 ) a specific test of the targeted conjunctions , ( 2 ) the TROG-2 and ( 3 ) a test of passives .
RESULTS	After Phase 1 , the therapy group showed significantly more progress than the waiting controls on the targeted conjunctions ( d = 1.6 ) and overall TROG-2 standard score ( d = 1.4 ) .
RESULTS	The two groups did not differ on the passives test .
RESULTS	After Phase 2 , the waiting controls made similar progress to those in the original therapy group , who maintained their previous progress .
RESULTS	Neither group showed progress on passives .
RESULTS	When the two groups were combined , significant progress was found on the specific conjunctions ( d = 1.3 ) and TROG-2 raw ( d = 1.1 ) and standard scores ( d = 0.9 ) .
RESULTS	Correlations showed no measures taken ( including Matrices and TVPS ) correlated significantly with progress on the targeted conjunctions or the TROG-2 .
CONCLUSIONS	Four hours of Shape Coding therapy led to significant gains on comprehension of coordinating conjunctions which were maintained after 4 months .
CONCLUSIONS	Given the significant progress at a group level and the lack of reliable predictors of progress , this approach could be offered to other children with similar difficulties to the participants .
CONCLUSIONS	However , the intervention was delivered one-to-one by speech and language therapists , thus the effectiveness of this therapy method with other methods of delivery remains to be evaluated .

###24549027
OBJECTIVE	Few studies have used biomarkers of whole-grain intake to study its relation to glucose metabolism .
OBJECTIVE	We aimed to investigate the association between plasma alkylresorcinols ( AR ) , a biomarker of whole-grain rye and wheat intake , and glucose metabolism in individuals with metabolic syndrome ( MetS ) .
METHODS	Participants were 30-65 years of age , with body mass index 27-40 kg/m ( 2 ) and had MetS without diabetes .
METHODS	Individuals were recruited through six centers in the Nordic countries and randomized to a healthy Nordic diet ( ND , n = 96 ) , rich in whole-grain rye and wheat , or a control diet ( n = 70 ) , for 18-24 weeks .
METHODS	In addition , associations between total plasma AR concentration and C17 :0 / C21 :0 homolog ratio as an indication of the relative whole-grain rye intake , and glucose metabolism measures from oral glucose tolerance tests were investigated in pooled ( ND + control ) regression analyses at 18/24 weeks .
RESULTS	ND did not improve glucose metabolism compared with control diet , but the AR C17 :0 / C21 :0 ratio was inversely associated with fasting insulin concentrations ( P = 0.002 ) and positively associated with the insulin sensitivity indices Matsuda ISI ( P = 0.026 ) and disposition index ( P = 0.022 ) in pooled analyses at 18/24 weeks , even after adjustment for confounders .
RESULTS	The AR C17 :0 / C21 :0 ratio was not significantly associated with insulin secretion indices .
RESULTS	Total plasma AR concentration was not related to fasting plasma glucose or fasting insulin at 18/24 weeks .
CONCLUSIONS	The AR C17 :0 / C21 :0 ratio , an indicator of relative whole-grain rye intake , is associated with increased insulin sensitivity in a population with MetS .

###24228531
OBJECTIVE	To discuss the drug intervention in diversity changes of TCRVbeta gene in AIDS patients with incomplete immune reconstitution .
METHODS	PBMCs were isolated from 37 cases of AIDS patients failure to immune reconstitution before and after treatment with Immune 2 and 15 cases of HIV negative healthy donors .
METHODS	The human gene TCRVbeta CDR3 diversity quantitative detection reagent box were used , and mapped the distribution of gene scanning and calculated different CDR3 fragme of each Vbeta family size .
RESULTS	( 1 ) Gaussian distribution of TCRVbeta families in patients with incomplete immune reconstitution after one year of HAART , had been broken with the occurrence of the offset TCR lineage .
RESULTS	After six months of treatment of traditional Chinese medicine combined HAART , the TCR lineage has been partially restored .
RESULTS	( 2 ) Evaluated by the D ( distance ) value calculated by a quantitative analysis software which the kit provides , there were no significant difference in D value change between the two groups , but with traditional Chinese medicine can reduce the data variability .
RESULTS	( 3 ) CD4 + T cell counts had a significant correlation ( r = -0.772 , P = 0.000 ) with TCRVbeta genetic diversity .
CONCLUSIONS	Study of the mechanism showed oligoclonal of TCRVbeta family can get recovery in some degrees after treated by Immune 2 plus HAART , suggesting that the medicine may promote T-cell receptor gene rearrangement , helping immune cells to effectively identify the virus to reduce T-cell apoptosis .

###26200182
BACKGROUND	Studies examining the efficacy of a single preoperative dose of gabapentin for analgesia after cesarean delivery ( CD ) have been inconclusive .
BACKGROUND	The authors hypothesized that a perioperative course of gabapentin would improve analgesia after CD .
METHODS	This single-center , randomized , double-blind , placebo-controlled , parallel-group , superiority trial was designed to determine the analgesic efficacy of a perioperative course of gabapentin when added to a multimodal analgesic regimen .
METHODS	Women scheduled for elective CD during spinal anesthesia were randomized to receive a perioperative oral course of either gabapentin ( 600mg preoperatively followed by 200mg every 8h for 2 days ) or placebo .
METHODS	Postoperative pain was measured at 24 and 48h , at rest and on movement , on a visual analogue scale ( VAS , 0 to 100mm ) .
METHODS	The primary outcome was pain on movement at 24h .
METHODS	Neonatal outcomes , opiate consumption , VAS satisfaction ( 0 to 100mm ) , adverse effects , and persistent pain were also assessed .
RESULTS	Baseline characteristics were similar between groups .
RESULTS	There was a statistically significant but small reduction in VAS pain score ( mean [ 95 % CI ] ) on `` movement '' ( 40mm [ 36 to 45 ] vs. 47mm [ 42 to 51 ] ; difference , -7 mm [ -13 to 0 ] ; P = 0.047 ) at 24h in the gabapentin ( n = 100 ) compared with control group ( n = 97 ) .
RESULTS	There was more sedation in the gabapentin group at 24h ( 55 vs. 39 % , P = 0.026 ) but greater patient VAS satisfaction ( 87 vs. 77mm , P = 0.003 ) .
CONCLUSIONS	A perioperative course of gabapentin produces a clinically insignificant improvement in analgesia after CD and is associated with a higher incidence of sedation .

###24369953
OBJECTIVE	To evaluate the performance of the first years since the beginning of a mammographic population-based screening program .
METHODS	Women aged 49-69 were invited biennially for two-view film-screen mammography and double reading without arbitration was performed .
METHODS	Interval cancers ( ICs ) from 2001 to 2006 were identified using screening archives , local pathology archives , and hospital discharge records .
METHODS	The proportional incidence of IC was determined considering breast cancers expected without screening .
METHODS	Three offsite radiologists experienced in breast cancer screening blindly evaluated mammograms prior to diagnosis , randomly mixed with negative mammograms ( 1:2 ratio ) .
METHODS	Cases unrecalled at review were considered as true ICs , those recalled by only one reviewer as minimal signs , and those recalled by two or three reviewers as missed cancers .
METHODS	T and N stage of the reviewed ICs were evaluated and compared .
RESULTS	A total of 86,276 first level mammograms were performed .
RESULTS	Mean recall rate was 6.8 % at first and 4.6 % at repeat screening .
RESULTS	We had 476 screen-detected cancers and 145 ICs ( 10 of them ductal carcinomas in situ ) .
RESULTS	Absolute incidence was 17 per 10,000 screening examinations .
RESULTS	Invasive proportional incidence was 19 % ( 44/234 ) in the first year , 39 % ( 91/234 ) in the second year , and 29 % ( 135/468 ) in the two-year interval .
RESULTS	Of 145 ICs , 130 ( 90 % ) were reviewed mixed with 287 negative controls : 55 % ( 71/130 ) resulted to be true ICs , 24 % ( 31/130 ) minimal signs , and 22 % ( 28/130 ) missed cancers .
RESULTS	The rate of ICs diagnosed in the first year interval was 21 % ( 15/71 ) for true ICs , 46 % ( 13/28 ) for missed cancers , and 39 % ( 12/31 ) for minimal signs , with a significant difference of true ICs rate compared to missed cancers rate ( p = 0.012 ) .
RESULTS	A higher rate of T3 and T4 stages was found for missed cancers ( 18 % , 5/28 ) compared to minimal signs ( 6 % , 2/31 ) or true ICs ( 8 % , 6/71 ) , while the rate of N2 and N3 stage for both minimal signs ( 19 % , 6/31 ) or missed cancers ( 25 % , 7/28 ) was higher than that for true ICs ( 10 % , 7/71 ) , although all these differences were not significant ( p 0.480 ) .
CONCLUSIONS	These results showed the possibility to comply with European Community standards in the first years of a screening program implementation .

###24684867
BACKGROUND	Proponents of single-incision laparoscopic surgery ( SILS ) claim patients have less pain , faster recovery , and better long-term cosmetic results than patients who undergo multiport laparoscopy .
BACKGROUND	However , randomized comparisons are lacking .
BACKGROUND	This study presents the results of a prospective randomized trial of SILS or 3-port laparoscopic appendectomy .
METHODS	Adults with uncomplicated acute appendicitis were randomized 1:1 to either SILS or 3-port laparoscopic appendectomy .
METHODS	The primary end point was early postoperative pain ( measured by opiate usage and pain score in the first 12 hours ) .
METHODS	Secondary end points were operative time , complication rate ( including conversions ) , and recovery time ( days of oral opiate usage and return to work ) .
METHODS	After 6 months , body image and cosmetic appearance were assessed using a validated survey .
RESULTS	The trial was planned for 150 patients , but was halted after 75 patients when planned interim analysis showed that SILS patients had more postoperative pain ( pain score : 4.4 1.6 vs 3.5 1.5 ; p = 0.01 ) and higher inpatient opiate usage ( hydromorphone use : 3.9 1.9 mg vs 2.8 1.7 mg ; p = 0.01 ) than 3-port laparoscopy .
RESULTS	Operative time for SILS averaged 40 % longer ( 54 17 minutes vs 38 11 minutes ; p < 0.01 ) .
RESULTS	Only 1 SILS case was converted to 3-port .
RESULTS	There were no significant differences in length of stay , complications , oral pain medication usage after discharge , or return to work .
RESULTS	After 6 months , body image and cosmetic appearance were excellent for both groups and indistinguishable by most measures .
RESULTS	However , 3-port patients reported better physical attractiveness ( 4.0 0.4 vs 3.8 0.4 ; p = 0.04 ) and SILS patients reported better scars ( score 18.4 2.7 vs 16.4 3.0 ; p < 0.01 ) .
RESULTS	Results are reported as mean SD .
CONCLUSIONS	Single-incision laparoscopic surgery appendectomy resulted in more pain and longer operative times without improving short-term recovery or complications .
CONCLUSIONS	Long-term body image and cosmetic appearance were excellent in both groups .

###25356596
OBJECTIVE	Primary hyperuricemia , an excess of uric acid in the blood , is a major public health problem .
OBJECTIVE	In addition to the morbidity that is attributable to gout , hyperuricemia is also associated with metabolic syndrome , hypertension , and cardiovascular disease .
OBJECTIVE	This study aims to assess the genetic associations between Apolipoprotein E ( APOE ) polymorphisms and hyperuricemia in a Chinese population .
METHODS	A total of 770 subjects ( 356 hyperuricemic cases and 414 normouricemic controls ) were recruited from the Ningxia Hui Autonomous Region , China .
METHODS	A physical examination was performed and fasting blood was collected for biochemical tests , including determination of the levels of serum lipid , creatinine , and uric acid .
METHODS	Multi-ARMS PCR was applied to determine the APOE genotypes , followed by an investigation of the distribution of APOE genotypes and alleles frequencies in the controls and cases .
RESULTS	The frequencies of the APOE-23 genotype ( 17.70 % vs. 10.39 % , P = 0.003 ) and the APOE-2 allele ( 10.53 % vs. 5.80 % , P = 0.001 ) were significantly higher in the hyperuricemic group than in the normouricemic group .
RESULTS	Furthermore , male cases were more likely to have the APOE-23 genotype and APOE-2 allele , compared with male controls .
RESULTS	In both Han and Hui subjects , cases were more likely to have the APOE-23 genotype and the APOE-2 allele compared with controls .
RESULTS	Furthermore , multivariate logistic regression showed that carriers of the APOE-23 genotype ( P = 0.001 , OR = 2.194 ) and the 2 allele ( P = 0.001 , OR = 2.099 ) were significantly more likely to experience hyperuricemia than carriers of the 3/3 genotype and the 3 allele after adjustment for sex , body mass index ( BMI ) , diastolic blood pressure ( DBP ) , triglyceride ( TG ) , low density lipoprotein cholesterol ( LDL-C ) , creatinine ( Cr ) and fasting blood glucose ( FBG ) .
CONCLUSIONS	The APOE-23 genotype and the APOE-2 allele are associated with serum uric acid levels in Chinese subjects , indicating that individuals carrying the APOE-2 allele have a higher risk of hyperuricemia than non-carriers .

###26078236
OBJECTIVE	To investigate the clinical application of the fast track surgery ( FTS ) model based on preoperative nutritional risk screening ( NRS ) in patients with esophageal cancer .
METHODS	180 patients with esophageal cancer who underwent surgery between January 2008 and April 2014 were randomly divided into study and control groups based on matched-pairs .
METHODS	The study group underwent assessment using the NRS 2002 and received treatment before surgery and the control group was treated by the conventional method .
METHODS	Postoperative indicators including time to first exsufflation , time to defecation , time to chest tube removal , hospitalization duration , and postoperative complications were examined after surgery .
RESULTS	Compared with the control group , the postoperative indicators including time to first exsufflation ( 88.42.76 vs 57.832.68 hours ) , time to first defecation ( 4.681.71 vs 3.281.34 days ) , time to chest tube removal ( 4.300.25 vs 2.700.33 days ) , postoperative hospitalization durations ( 11.711.39 vs 9.000.78 days ) , and total complication rate ( 18.9 % [ 17/90 ] vs 6.67 % [ 6/90 ] ) were all significantly reduced in the study group ( p < 0.05 ) .
CONCLUSIONS	The FTS model based on NRS can effectively promote postoperative rehabilitation of patients , reduce the incidence of postoperative complications , and shorten hospital stay .

###24568171
OBJECTIVE	A randomized , controlled clinical trial was conducted to compare the safety and whitening efficacy of high-adhesion tooth-whitening strips with a marketed in-office professional tooth-whitening system .
METHODS	This open-label study was conducted in a private dental practice , and adult volunteers were assigned ( 2:1 ) to either 9.5 percent hydrogen-peroxide whitening strips ( Strip group ) or an in-office light plus 25 percent hydrogen-peroxide whitening gel treatment ( In-office group ) .
METHODS	The Strip group was instructed to treat the maxillary arch once daily for 30 minutes over a 20-day period , while the In-office group underwent professional application of light plus whitening gel in a single office visit .
METHODS	Whitening response was measured as change in yellowness ( b * ) and lightness ( L * ) at Day 21 using standardized digital images of the maxillary anterior teeth , while safety was assessed as tooth sensitivity and oral irritation occurrence .
METHODS	A total of 45 subjects enrolled , were randomized , and received treatment ; 44 completed the study .
RESULTS	At Day 21 , significant improvement in b * and L * was noted in both groups ( P0 .001 ) .
RESULTS	The adjusted mean ( SE ) L * in the Strip group ( 1.72 ( 0.104 ) ) was significantly greater than that in the In-office group ( 1.17 ( 0.153 ) ) ( P = 0.005 ) .
RESULTS	Both test products were well tolerated .
RESULTS	Overall , both the strip and in-office treatments resulted in significant tooth whitening .

###24518002
OBJECTIVE	To evaluate the High Five for Kids intervention effect on television within subgroups , examine participant characteristics associated with process measures and assess perceived helpfulness of television intervention components .
METHODS	High Five ( randomized controlled trial of 445 overweight/obese 2-7 year-olds in Massachusetts [ 2006-2008 ] ) reduced television by 0.36 h/day .
METHODS	1-year effects on television viewing , stratified by subgroup , were assessed using linear regression .
METHODS	Among intervention participants ( n = 253 ) , associations of intervention component helpfulness with television reduction were examined using linear regression and associations of participant characteristics with processes linked to television reduction ( choosing television and completing intervention visits ) were examined using logistic regression .
RESULTS	High Five reduced television across subgroups .
RESULTS	Parents of Latino ( versus white ) children had lower odds of completing 2 study visits ( Odds Ratio : 0.39 [ 95 % Confidence Interval : 0.18 , 0.84 ] ) .
RESULTS	Parents of black ( versus white ) children had higher odds of choosing television ( Odds Ratio : 2.23 [ 95 % Confidence Interval : 1.08 , 4.59 ] ) , as did parents of obese ( versus overweight ) children and children watching 2 h/day ( versus < 2 ) at baseline .
RESULTS	Greater perceived helpfulness was associated with greater television reduction .
CONCLUSIONS	Clinic-based motivational interviewing reduces television viewing in children .
CONCLUSIONS	Low cost education approaches ( e.g. , printed materials ) may be well-received .
CONCLUSIONS	Parents of children at higher obesity risk could be more motivated to reduce television .

###25107900
OBJECTIVE	To evaluate efficacy and safety of intravitreal aflibercept ( IVT-AFL ) in Japanese patients with wet age-related macular degeneration ( wAMD ) from the VIEW 2 trial .
METHODS	In this double-masked study , patients were randomised to : 0.5 mg IVT-AFL every 4weeks ( 0.5 q4 ) ; 2mg IVT-AFL every 4weeks ( 2q4 ) ; 2mg IVT-AFL every 8weeks ( 2q8 ) after 3 monthly injections ; or 0.5 mg ranibizumab every 4weeks ( Rq4 ) .
METHODS	Main efficacy outcomes included vision maintenance and best-corrected visual acuity ( BCVA ) at week 52 .
RESULTS	At week 52 , all Japanese patients in the IVT-AFL groups ( n = 70 ) maintained vision , compared with 96 % of Japanese patients ( n = 23/24 ) treated with ranibizumab .
RESULTS	Japanese patients in all treatment groups showed improvement in BCVA after treatment .
RESULTS	The Rq4 , 2q4 and 2q8 groups experienced similar gains in BCVA from baseline .
RESULTS	The 0.5 q4 group had higher gains due to an unexpected drop in BCVA between screening and baseline .
RESULTS	Central retinal thickness and mean area of choroidal neovascularisation decreased in all treatment groups with similar magnitude .
RESULTS	Ocular treatment-emergent adverse events were balanced across treatment groups .
CONCLUSIONS	IVT-AFL was effective and well tolerated in Japanese patients .
CONCLUSIONS	Outcomes in this population were consistent with those in the overall VIEW 2 population .
BACKGROUND	NCT00637377 .

###25232809
OBJECTIVE	Observational studies suggest a role for dietary nutrients such as vitamin E and selenium in cataract prevention .
OBJECTIVE	However , the results of randomized clinical trials of vitamin E supplements and cataract have been disappointing and are not yet available for selenium .
OBJECTIVE	To test whether long-term supplementation with selenium and vitamin E affects the incidence of cataract in a large cohort of men .
METHODS	The Selenium and Vitamin E Cancer Prevention Trial ( SELECT ) Eye Endpoints Study was an ancillary study of the Southwest Oncology Group-coordinated SELECT , a randomized placebo-controlled 4-arm trial of selenium and vitamin E conducted among 35,533 men , 50 years and older for African American participants and 55 years and older for all other men , at 427 participating sites in the United States , Canada , and Puerto Rico .
METHODS	A total of 11,267 SELECT participants from 128 SELECT sites participated in the SELECT Eye Endpoints ancillary study .
METHODS	Individual supplements of selenium ( 200 g per day from L-selenomethionine ) and vitamin E ( 400 IU per day of all rac -- tocopheryl acetate ) .
METHODS	Incident cataract was defined as a lens opacity , age related in origin , and responsible for a reduction in best-corrected visual acuity to 20/30 or worse based on self-reports confirmed by medical record review .
METHODS	Cataract extraction was defined as the surgical removal of an incident cataract .
RESULTS	During a mean ( SD ) of 5.6 ( 1.2 ) years of treatment and follow-up , 389 cases of cataract were documented .
RESULTS	There were 185 cataracts in the selenium group and 204 in the no selenium group ( hazard ratio , 0.91 ; 95 % CI , 0.75-1 .11 ; P = .37 ) .
RESULTS	For vitamin E , there were 197 cases in the treated group and 192 in the placebo group ( hazard ratio , 1.02 ; 95 % CI , 0.84-1 .25 ; P = .81 ) .
RESULTS	Similar results were observed for cataract extraction .
CONCLUSIONS	These data from a large cohort of apparently healthy men indicate that long-term daily supplementation with selenium and/or vitamin E is unlikely to have a large beneficial effect on age-related cataract .
BACKGROUND	ClinicalTrials.gov Identifier : NCT00784225 .

###25066366
BACKGROUND	The course of bipolar disorder progressively worsens in some patients .
BACKGROUND	Although responses to pharmacotherapy appear to diminish with greater chronicity , less is known about whether patients ' prior courses of illness are related to responses to psychotherapy .
METHODS	Embedded in the Systematic Treatment Enhancement Program for Bipolar Disorder ( STEP-BD ) was a randomized controlled trial of psychotherapy for bipolar depression comparing the efficacy of intensive psychotherapy with collaborative care ( a three-session psycho-educational intervention ) .
METHODS	We assessed whether the number of previous mood episodes , age of illness onset , and illness duration predicted or moderated the likelihood of recovery and time until recovery from a depressive episode in patients in the two treatments .
RESULTS	Independently of treatment condition , participants with one to nine prior depressive episodes were more likely to recover and had faster time to recovery than those with 20 or more prior depressive episodes .
RESULTS	Participants with fewer than 20 prior manic episodes had faster time to recovery than those with 20 or more episodes .
RESULTS	Longer illness duration predicted a longer time to recovery .
RESULTS	Participants were more likely to recover in intensive psychotherapy than collaborative care if they had 10-20 prior episodes of depression [ number needed to treat ( NNT ) = 2.0 ] , but equally likely to respond to psychotherapy and collaborative care if they had one to nine ( NNT = 32.0 ) or > 20 ( NNT = 9.0 ) depressive episodes .
CONCLUSIONS	Number of previous mood episodes and illness duration are associated with the likelihood and speed of recovery among bipolar patients receiving psychosocial treatments for depression .

###24924798
BACKGROUND	This article reports on patient-reported sexual dysfunction and micturition symptoms following a randomized trial of laparoscopic and open surgery for rectal cancer .
METHODS	Patients in the COLOR II randomized trial , comparing laparoscopic and open surgery for rectal cancer , completed the European Organization for Research and Treatment of Cancer ( EORTC ) QLQ-CR38 questionnaire before surgery , and after 4weeks , 6 , 12 and 24months .
METHODS	Adjusted mean differences on a 100-point scale were calculated using changes from baseline value at the various time points in the domains of sexual functioning , sexual enjoyment , male and female sexual problems , and micturition symptoms .
RESULTS	Of 617 randomized patients , 385 completed this phase of the trial .
RESULTS	Their mean age was 671years .
RESULTS	Surgery caused an anticipated reduction in genitourinary function after 4weeks , with no significant differences between laparoscopic and open approaches .
RESULTS	An improvement in sexual dysfunction was seen in the first year , but some male sexual problems persisted .
RESULTS	Before operation 645 per cent of men in the laparoscopic group and 556 per cent in the open group reported some degree of erectile dysfunction .
RESULTS	This increased to 811 and 805 per cent respectively 4weeks after surgery , and 763 versus 755 per cent at 12months , with no significant differences between groups .
RESULTS	Micturition symptoms were less affected than sexual function and gradually improved to preoperative levels by 6months .
RESULTS	Adjusting for confounders , including radiotherapy , did not change these results .
CONCLUSIONS	Sexual dysfunction is common in patients with rectal cancer , and treatment ( including surgery ) increases the proportion of patients affected .
CONCLUSIONS	A laparoscopic approach does not change this .
BACKGROUND	NCT0029779 ( http://www.clinicaltrials.gov ) .

###24335762
OBJECTIVE	Rates of obesity are greatest in middle age .
OBJECTIVE	Obesity is associated with altered activity of brain networks sensing food-related stimuli and internal signals of energy balance , which modulate eating behaviour .
OBJECTIVE	The impact of healthy mid-life ageing on these processes has not been characterised .
OBJECTIVE	We therefore aimed to investigate changes in brain responses to food cues , and the modulatory effect of meal ingestion on such evoked neural activity , from young adulthood to middle age .
METHODS	Twenty-four healthy , right-handed subjects , aged 19.5-52 .6 years , were studied on separate days after an overnight fast , randomly receiving 50ml water or 554kcal mixed meal before functional brain magnetic resonance imaging while viewing visual food cues .
RESULTS	Across the group , meal ingestion reduced food cue-evoked activity of amygdala , putamen , insula and thalamus , and increased activity in precuneus and bilateral parietal cortex .
RESULTS	Corrected for body mass index , ageing was associated with decreasing food cue-evoked activation of right dorsolateral prefrontal cortex ( DLPFC ) and precuneus , and increasing activation of left ventrolateral prefrontal cortex ( VLPFC ) , bilateral temporal lobe and posterior cingulate in the fasted state .
RESULTS	Ageing was also positively associated with the difference in food cue-evoked activation between fed and fasted states in the right DLPFC , bilateral amygdala and striatum , and negatively associated with that of the left orbitofrontal cortex and VLPFC , superior frontal gyrus , left middle and temporal gyri , posterior cingulate and precuneus .
RESULTS	There was an overall tendency towards decreasing modulatory effects of prior meal ingestion on food cue-evoked regional brain activity with increasing age .
CONCLUSIONS	Healthy ageing to middle age is associated with diminishing sensitivity to meal ingestion of visual food cue-evoked activity in brain regions that represent the salience of food and direct food-associated behaviour .
CONCLUSIONS	Reduced satiety sensing may have a role in the greater risk of obesity in middle age .

###24745692
OBJECTIVE	To determine whether the addition of spa therapy to home exercises provides any benefit over exercises and the usual treatment alone in the management of generalised osteoarthritis associated with knee osteoarthritis .
METHODS	This study was a post-hoc subgroup analysis of our randomised multicentre trial ( www.clinicaltrial.gov : NCT00348777 ) .
METHODS	Participants who met the inclusion criteria of generalized osteoarthritis ( Kellgren , American College of Rheumatology , or Dougados criteria ) were extracted from the original randomised controlled trial .
METHODS	They had been randomised using Zelen randomisation .
METHODS	The treatment group received 18days of spa treatment in addition to a home exercise programme .
METHODS	Main outcome was number of patients achieving minimal clinically important improvement at six months ( MCII ) ( -19.9 mm on the VAS pain scale and/or -9.1 points in a WOMAC function subscale ) , and no knee surgery .
METHODS	Secondary outcomes included the `` patient acceptable symptom state '' ( PASS ) defined as VAS pain 32.3 mm and/or WOMAC function subscale 31 points .
RESULTS	From the original 462 participants , 214 patients could be categorized as having generalised osteoarthritis .
RESULTS	At sixth month , 182 ( 88 in control and 94 in SA group ) patients , were analysed for the main criteria .
RESULTS	MCII was observed more often in the spa group ( n = 52/94 vs. 38/88 , P = 0.010 ) .
RESULTS	There was no difference for the PASS ( n = 19/88 vs. 26/94 , P = 0.343 ) .
CONCLUSIONS	This study indicates that spa therapy with home exercises may be superior to home exercise alone in the management of patients with GOA associated with knee OA .

###25164315
OBJECTIVE	This study compared the efficacy of intravenous magnesium sulphate , terbutaline and aminophylline for children with acute , severe asthma poorly responsive to standard initial treatment .
METHODS	We enrolled 100 children , aged one to 12 years , who had failed to respond to initial standard treatment for acute , severe asthma , in this randomised controlled trial .
METHODS	They received either intravenous magnesium sulphate , terbutaline or aminophylline .
METHODS	Responses were monitored using a modified Clinical Asthma Severity ( CAS ) score .
METHODS	The primary outcome was treatment success , defined as a reduction in the CAS of four points or more 1 h after starting the intervention .
RESULTS	The magnesium sulphate group had higher treatment success ( 33/34 , 97 % ) than the terbutaline and aminophylline groups ( both 23/33 , 70 % ) ( p = 0.006 ) and faster resolution of retractions , wheeze and dyspnoea ( p < 0.001 ) .
RESULTS	No adverse events occurred among patients receiving magnesium sulphate , but two patients receiving terbutaline had hypokalemia and nine patients receiving aminophylline had nausea and , or , vomiting .
CONCLUSIONS	Adding a single dose of Intravenous magnesium sulphate to inhaled beta2-agonists and corticosteroids was more effective , and safer , than using terbutaline or aminophylline when treating a child with acute severe asthma poorly responsive to initial treatment .

###25132459
OBJECTIVE	To evaluate the efficacy and adverse effects of an i.v. infusion of paracetamol during the active phase of labor as compared with sterile water ( placebo ) as a method for intrapartum analgesia .
METHODS	In a triple-blind , randomized , placebo-controlled trial , 120 low-risk primiparous women presenting in active labor at Ain Shams University Maternity Hospital , Cairo , Egypt , between August 2011 and October 2012 , were allocated to receive either 1000 mg i.v. of paracetamol ( n = 60 ) or sterile water ( n = 60 ) .
METHODS	The primary outcomes were the efficacy of the drug to supply adequate analgesia as measured by a change in the visual analog scale ( VAS ) pain intensity score at various time points after drug administration and the need for additional rescue analgesia .
METHODS	The secondary outcomes included the presence of adverse maternal or fetal events .
RESULTS	Compared to controls , i.v. infusion of paracetamol was associated with significantly lower VAS score 15 and 30 min after the start of medication ; also , there was a significantly lower incidence of need for rescue medication ( 8/57 [ 14 % ] vs 49/59 [ 83.1 % ] , P < 0.001 ) at 60 min after the start of medication .
RESULTS	There were no recorded maternal adverse effects in either group .
RESULTS	There were no differences in occurrence of intrapartum fetal distress or neonatal Apgar scores between both groups .
CONCLUSIONS	Paracetamol appears to be a safe and effective medicine that can be used during the intrapartum period .

###25251676
OBJECTIVE	Alternate day fasting ( ADF ; 24-h feeding/24-h 25 % energy intake at lunchtime ) , is effective for weight loss , but diet tolerability is questionable .
OBJECTIVE	Moving the fast day meal to dinnertime , or dividing it into smaller meals , may improve tolerability .
OBJECTIVE	Accordingly , this study compared the effects of ADF with three meal times on body weight and heart disease risk .
METHODS	Obese subjects ( n = 74 ) were randomized to 1 of 3 groups for 8 weeks : 1 ) ADF-L : lunch , 2 ) ADF-D : dinner , or 3 ) ADF-SM : small meals .
RESULTS	Body weight decreased similarly ( P < 0.001 ) in all groups ( ADF-L : 3.50.4 kg , ADF-D 4.10.5 kg , ADF-SM 4.00.5 kg ) .
RESULTS	Reductions ( P < 0.001 ) in fat mass and visceral fat were also comparable .
RESULTS	Plasma lipids remained unchanged , and low density lipoprotein ( LDL ) particle size increased ( P < 0.05 ) in all groups ( 1.30.5 ) .
RESULTS	Systolic blood pressure decreased ( P < 0.05 ) by ADF-SM only .
RESULTS	Fasting glucose , insulin , and HOMA-IR remained unchanged .
CONCLUSIONS	Thus , allowing individuals to consume the fast day meal at dinner or small meals produces similar weight loss and cardio-protection as consuming the meal at lunch .
CONCLUSIONS	This flexibility in meal timing may increase tolerability and long-term adherence to ADF protocols .

###25161026
OBJECTIVE	To determine whether aminophylline reduced the duration of respiratory support in children admitted to intensive care with bronchiolitis .
METHODS	A multicentre , randomised , double-blind , placebo controlled trial .
METHODS	Paediatric intensive care units in teaching hospitals .
METHODS	Forty-five children with severe bronchiolitis .
METHODS	Patients were randomly assigned to receive an infusion of aminophylline ( 23 ) or placebo ( 22 ) .
METHODS	The primary outcome measure was the number of hours of respiratory support required in the 120 hours after randomisation ; respiratory support was defined as either nasal continuous positive airways pressure or mechanical ventilation .
RESULTS	The trial was stopped early due to poor recruitment .
RESULTS	Respiratory support was required for a median of only 1.5 days ( interquartile range [ IQR ] , 0.4-3 .5 days ) in the aminophylline group compared with 1.9 days ( IQR , 0.3-3 .5 ) days in the placebo group .
RESULTS	However , more patients in the placebo group were receiving respiratory support at the time of randomisation and , after adjustment for this , there was no suggestion of a beneficial effect of aminophylline among the small number of patients studied ( P = 0.54 , exact log-rank test stratified by respiratory support at the time of randomisation and censored at the time of death in one child in the aminophylline group ) .
CONCLUSIONS	Not enough children were recruited for the study to test the hypothesis that aminophylline reduces the need for respiratory support in severe bronchiolitis .
CONCLUSIONS	Consequently , the role of aminophylline in the management of severe bronchiolitis remains unknown .

###24725898
BACKGROUND	We aimed to compare the effectiveness of immobilization in abduction and external rotation vs immobilization in adduction and internal rotation after primary anterior dislocation of the shoulder .
METHODS	The study randomized 102 patients ( age range , 15-55 years ) with the diagnosis of primary anterior dislocation of the shoulder to receive immobilization in adduction and internal rotation ( AdIR , n = 51 ) using sling and swathe bandage or immobilization in abduction and external rotation ( AbER , n = 51 ) with a stabilizer brace .
METHODS	Patients received a rehabilitation program 3 weeks after the intervention .
RESULTS	After a 24-month follow-up , 33.3 % in the AdIR group and 3.9 % in the AbER group had recurrence ( P < .001 ) .
RESULTS	The difference in the recurrence rate was greater in the subgroup aged between 31 and 40 years ( 44.8 % in the AdIR group and 3.8 % in the AbER group , P < .001 ) .
RESULTS	Ten patients in the AbER group ( 19.6 % ) and 3 in the AdIR group ( 5.8 % ) discontinued shoulder immobilization before 3 weeks ( P = .03 ) .
RESULTS	In patients without recurrence , the anterior apprehension test was positive in 6 of 34 in the AdIR group ( 17.6 % ) and in 4 of 49 in the AbER group ( 8.1 % , P = .19 ) .
CONCLUSIONS	Immobilization with the shoulder joint in abduction and external rotation is an effective method to reduce the risk of recurrence after primary anterior shoulder dislocations and should be preferred to the traditional method of immobilization in adduction and internal rotation in clinical practice .

###25882029
BACKGROUND	Deep brain stimulation ( DBS ) has been proposed as a treatment option for severe Tourette 's syndrome on the basis of findings from open-label series and small double-blind trials .
BACKGROUND	We aimed to further assess the safety and efficacy of bilateral globus pallidus internus ( GPi ) DBS in patient 's with severe Tourette 's syndrome .
METHODS	In a randomised , double-blind , crossover trial , we recruited eligible patients ( severe medically refractory Tourette 's syndrome , age 20 years ) from two clinics for tertiary movement disorders in the UK .
METHODS	Enrolled patients received surgery for GPi DBS and then were randomly assigned in a 1:1 ratio ( computer-generated pairwise randomisation according to order of enrolment ) to receive either stimulation on-first or stimulation off-first for 3 months , followed by a switch to the opposite condition for a further 3 month period .
METHODS	Patients and rating clinicians were masked to treatment allocation ; an unmasked clinician was responsible for programming the stimulation .
METHODS	The primary endpoint was difference in Yale Global Tic Severity Scale ( YGTSS ) total score between the two blinded conditions , assessed with repeated measures ANOVA , in all patients who completed assessments during both blinded periods .
METHODS	After the end of the blinded crossover phase , all patients were offered continued DBS and continued to have open-label stimulation adjustments and objective assessments of tic severity until database lock 1 month after the final patient 's final trial-related visit .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01647269 .
RESULTS	Between Nov 5 , 2009 , and Oct 16 , 2013 , we enrolled 15 patients ( 11 men , four women ; mean age 347 years [ SD 100 ] ) .
RESULTS	14 patients were randomly assigned and 13 completed assessments in both blinded periods ( seven in the on-first group , six in the off-first group ) .
RESULTS	Mean YGTSS total score in these 13 patients was 879 ( SD 92 ) at baseline , 807 ( SD 120 ) for the off-stimulation period , and 683 ( SD 186 ) for the on-stimulation period .
RESULTS	Pairwise comparisons in YGTSS total scores after Bonferroni correction were significantly lower at the end of the on-stimulation period compared with the off-stimulation period , with a mean improvement of 124 points ( 95 % CI 01-247 , p = 0048 ) , equivalent to a difference of 153 % ( 95 % CI 53-253 ) .
RESULTS	All 15 patients received stimulation in the open-label phase .
RESULTS	Overall , three serious adverse events occurred ( two infections in DBS hardware at 2 and 7 weeks postoperatively , and one episode of deep-brain-stimulation-induced hypomania during the blinded on-stimulation period ) ; all three resolved with treatment .
CONCLUSIONS	GPi stimulation led to a significant improvement in tic severity , with an overall acceptable safety profile .
CONCLUSIONS	Future research should concentrate on identifying the most effective target for DBS to control both tics and associated comorbidities , and further clarify factors that predict individual patient response .
BACKGROUND	UK National Health Service .

###25047825
BACKGROUND	The Sodium Lowering in Dialysate ( SoLID ) trial is an ongoing a multi-center , prospective , randomised , single-blind ( assessor ) , controlled , parallel assignment clinical trial , enrolling 96 home and self-care hemodialysis ( HD ) patients from 7 centers in New Zealand .
BACKGROUND	The trial will evaluate the hypothesis that lower dialysate [ Na + ] during HD results in lower left ventricular ( LV ) mass .
BACKGROUND	Since it 's inception , observational evidence has suggested increased mortality risk with lower dialysate [ Na + ] , possibly due to exacerbation of intra-dialytic hypotension and subsequent myocardial micro-injury .
BACKGROUND	The Myocardial Micro-injury and Cardiac Remodeling Extension Study in the Sodium Lowering In Dialysate Trial ( Mac-SoLID study ) aims to determine whether lower dialysate [ Na + ] results in ( i ) increased levels of high-sensitivity Troponin T ( hsTnT ) , a well-established marker of intra-dialytic myocardial micro-injury in HD populations , and ( ii ) increased fixed LV segmental wall motion abnormalities , a marker of recurrent myocardial stunning and micro-injury , and ( iii ) detrimental changes in LV geometry due to maladaptive homeostatic mechanisms .
METHODS	The SoLID trial and the Mac-SoLID study are funded by the Health Research Council of New Zealand .
METHODS	Key exclusion criteria : patients who dialyse > 3.5 times per week , pre-dialysis serum sodium < 135 mM , and maintenance haemodiafiltration .
METHODS	In addition , some medical conditions , treatments or participation in other dialysis trials that contraindicate the study intervention or confound its effects , will be exclusion criteria .
METHODS	The intervention and control groups will receive dialysate sodium 135 mM and 140 mM respectively , for 12 months .
METHODS	The primary outcome measure for the Mac-SOLID study is repeated measures of [ hsTnT ] at 0 , 3 , 6 , 9 , and 12 months .
METHODS	The secondary outcomes will be assessed using cardiac magnetic resonance imaging ( MRI ) , and comprise LV segmental wall motion abnormality scores , LV mass to volume ratio and patterns of LV remodeling at 0 and 12 months .
CONCLUSIONS	The Mac-SoLID study enhances and complements the SoLID trial .
CONCLUSIONS	It tests whether potential gains in cardiovascular health ( reduced LV mass ) which low dialysate [ Na + ] is expected to deliver , are counteracted by deterioration in cardiovascular health through alternative mechanisms , namely repeated LV stunning and micro-injury .
BACKGROUND	Australian and New Zealand Clinical Trials Registry number : ACTRN12611000975998 .

###25280420
OBJECTIVE	The role of saturated fatty acids ( SFAs ) in chronic disease remains controversial ; inflammation is one pathway by which SFAs influence the risk for chronic disease .
OBJECTIVE	The aim of this study was to investigate the associations between red blood cell ( RBC ) phospholipid SFAs and systemic inflammation .
METHODS	As part of a randomized controlled trial , we measured RBC phospholipid FA composition in 55 generally healthy adults twice at 3-mo intervals .
METHODS	We estimated associations of RBC total SFAs and two major SFA subtypes , palmitic and stearic acids , with C-reactive protein ( CRP ) , interleukin ( IL ) -6 , white blood count ( WBC ) , and a composite inflammation measure using generalized estimating equations in multivariable FA substitution models .
RESULTS	Mean ( SD ) SFA level across both visits was 45 % 3 % of the total RBC FAs , mainly palmitic ( 21 % 1 % ) and stearic ( 17 % 3 % ) acids .
RESULTS	In models adjusted for age , sex , race , smoking , body mass index , statin use , aspirin use , transunsaturated FAs , and -3 FAs , SFAs were significantly associated with IL-6 ( 20 % increase per 1 SD increment ; 95 % confidence interval [ CI ] , 0.03 % -43 % ; P = 0.05 ) and the composite inflammation measure ( P = 0.05 ) and marginally associated with CRP ( 34 % increase ; 95 % CI , -1 % to 81 % ; P = 0.06 ) , but not associated with WBC .
RESULTS	Stearic acid was positively associated with CRP ( 35 % increase ; 95 % CI , 2 % -79 % ; P = 0.04 ) .
RESULTS	Palmitic acid was marginally associated with the composite inflammation measure ( P = 0.06 ) and , upon additional -6 FA adjustment , significantly associated with IL-6 ( 15 % increase ; 95 % CI , 0.4 % -27 % ; P = 0.006 ) .
CONCLUSIONS	RBC SFAs , which represent longer-term dietary intake , are positively associated with inflammation .
CONCLUSIONS	In particular , palmitic acid was associated with IL-6 , and stearic acid was associated with CRP after multivariable adjustment .

###24725616
OBJECTIVE	To compare the efficacy and safety of two insulin intensification strategies in patients with type 2 diabetes inadequately controlled on basal insulin glargine with metformin and/or pioglitazone .
METHODS	A multinational , randomized , open-label trial that compared insulin lispro low mixture ( LM25 ; n = 236 ) twice daily with a basal-prandial regimen of insulin glargine once daily and insulin lispro once daily ( IGL ; n = 240 ) over 24 weeks in patients with HbA1c 7.5-10 .5 % and fasting plasma glucose 6.7 mmol/l .
METHODS	The primary objective was to assess non-inferiority [ per-protocol ( PP ) population ] , and then superiority [ intention-to-treat ( ITT ) population ] , of LM25 versus IGL according to change in HbA1c after 24 weeks ( non-inferiority margin 0.4 % , two-sided significance level 0.05 ) .
RESULTS	Estimated change [ least squares ( LS ) mean ( 95 % CI ) ] in HbA1c after 24 weeks : -1.30 ( -1.44 , -1.16 ) % with LM25 and -1.08 ( -1.22 , -0.94 ) % with IGL .
RESULTS	Non-inferiority was shown [ LS mean ( 95 % CI ) HbA1c treatment difference -0.21 ( -0.38 , -0.04 ) ( PP population ) ] ; gated superiority assessment showed a statistically significant advantage for LM25 ( p = 0.010 ; ITT population ) .
RESULTS	Mean blood glucose , glycaemic variability , overall tolerability and hypoglycaemic episodes per patient-year did not show significant differences between treatments during the study .
CONCLUSIONS	In patients with type 2 diabetes inadequately controlled on once-daily basal insulin glargine and metformin and/or pioglitazone , intensification with LM25 was superior to a basal-prandial approach in terms of reduction in HbA1c after 24 weeks and did not increase hypoglycaemia episodes .

###24478238
BACKGROUND	Prototyping technologies for reconstructions consist of obtaining a 3-dimensional model of the object of interest .
BACKGROUND	Solid models are constructed by the deposition of materials in successive layers .
BACKGROUND	The purpose of this study was to perform a double-blind , randomized , prospective study to evaluate the efficacy of prototype use in head and neck surgeries .
METHODS	Thirty-seven cases were randomized into prototype and nonprototype groups .
METHODS	The following factors were recorded : the time of plate and locking screw apposition , flap size , time for reconstruction , and an aesthetic evaluation .
RESULTS	The prototype group exhibited a reduced surgical time ( 43.7 minutes vs 127.7 minutes , respectively ; p = .001 ) , a tendency to reduce the size of the bone flap taken for reconstruction , and better aesthetic results than the group that was not prototyped .
CONCLUSIONS	The use of prototyping demonstrated a trend toward a reduced surgical time , smaller bone flaps , and better aesthetic results .

###25082304
OBJECTIVE	This study 's objective was to determine the efficacy of benefits counseling in a clinical trial .
OBJECTIVE	There has been concern that disability payments for psychiatric disorders reduce incentives for employment and rehabilitation .
OBJECTIVE	Benefits counseling , with education about opportunities to work and the financial implications of work on receipt of disability benefits , may counter these disincentives .
METHODS	This single-blind , six-month randomized clinical trial enrolled 84 veterans who had applied for service-connected compensation for a psychiatric condition .
METHODS	Veterans were randomly assigned to either four sessions of benefits counseling or of a control condition involving orientation to the U.S Department of Veterans Affairs health care system and services .
METHODS	Days of paid work and work-related activities were assessed at follow-up visits by using a timeline follow-back calendar .
RESULTS	Veterans assigned to benefits counseling worked for pay for significantly more days than did veterans in the control group ( effect size = .69 , p < .05 ) , reflecting an average of three more days of paid employment during the 28 days preceding the six-month follow-up .
RESULTS	Benefits counseling was associated with increased use of mental health services , but this correlation did not mediate the effect of benefits counseling on working .
CONCLUSIONS	Barriers to employment associated with disability payments are remediable with basic counseling .
CONCLUSIONS	More research is needed to understand the active ingredient of this counseling and to strengthen the intervention .

###25675650
BACKGROUND	Many believe that the regular treatment for multibacillary ( MB ) leprosy cases could be shortened .
BACKGROUND	A shorter treatment allowing uniformity in treatment for all cases renders case classification superfluous and therefore simplifies leprosy control .
OBJECTIVE	To evaluate the association between treatment duration and the trend in bacteriological index ( BI ) decrease over time among patients given Uniform MDT ( UMDT ) compared to those given regular MDT ( RMDT ) .
METHODS	An open-label randomised clinical trial to compare the present routine treatment with one lasting six month .
METHODS	Patient intake was from March 2007 to February 2012 .
METHODS	To evaluate the trend of BI as a function of time , a multilevel linear with mixed effects model was fixed to the two study groups and also four groups after stratification by BI , less than 3 and 3 or more .
RESULTS	The BI fall was higher among those taking RMDT , this difference however was not statistically significant .
CONCLUSIONS	The results presented here support the possibility of use of UMDT in the field , but further follow up is still needed for a final conclusion .

###25142791
BACKGROUND	To assess whether the Multidisciplinary Risk Assessment and Management Program for Patients with Diabetes Mellitus ( RAMP-DM ) led to improvements in biomedical outcomes , observed cardiovascular events and predicted cardiovascular risks after 12-month intervention in the primary care setting .
METHODS	A random sample of 1,248 people with diabetes enrolled to RAMP-DM for at least 12months was selected and 1,248 people with diabetes under the usual primary care were matched by age , sex , and HbA1c level at baseline as the usual care group .
METHODS	Biomedical and cardiovascular outcomes were measured at baseline and at 12-month after the enrollment .
METHODS	Difference-in-differences approach was employed to measure the effect of RAMP-DM on the changes in biomedical outcomes , proportion of subjects reaching treatment targets , observed and predicted cardiovascular risks .
RESULTS	Compared to the usual care group , RAMP-DM group had lower cardiovascular events incidence ( 1.21 % vs 2.89 % , P = 0.003 ) , and net decrease in HbA1c ( -0.20 % , P < 0.01 ) , SBP ( -3.62 mmHg , P < 0.01 ) and 10-year cardiovascular disease ( CVD ) risks ( total CVD risk , -2.06 % , P < 0.01 ; coronary heart disease ( CHD ) risk , -1.43 % , P < 0.01 ; stroke risk , -0.71 % , P < 0.01 ) .
RESULTS	The RAMP-DM subjects witnessed significant rises in the proportion of reaching treatment targets of HbA1c , and SBP/DBP .
RESULTS	After adjusting for confounding variables , the significance remained for HbA1c , predicted CHD and stroke risks .
CONCLUSIONS	The RAMP-DM resulted in greater improvements in HbA1c and reduction in observed and predicted cardiovascular risks at 12months follow-up , which indicated a risk-stratification multidisciplinary intervention was an effective strategy for managing Chinese people with diabetes in the primary care setting .
BACKGROUND	ClinicalTrials.gov , NCT02034695 .

###25403703
BACKGROUND	The incidence of sick sinus syndrome will increase due to population ageing .
BACKGROUND	Consequently , this will result in an increase in the number of pacemaker implantations .
BACKGROUND	The atrial lead is usually implanted in the right atrial appendage , but this position may be ineffective for prevention of atrial fibrillation .
BACKGROUND	It has been suggested that pacing distally in the coronary sinus might be more successful in preventing atrial fibrillation episodes .
BACKGROUND	The aim of this trial is to study the efficacy of distal coronary sinus versus right atrial appendage pacing in preventing atrial fibrillation episodes in patients with sick sinus syndrome .
METHODS	This study is designed as a multicenter , randomized controlled trial .
METHODS	Patients with sick sinus syndrome and at least one atrial fibrillation episode of 30 seconds or more in the six months before recruitment will be eligible for participation in this study.All participants will be randomized between pacing distally in the coronary sinus and right atrial appendage .
METHODS	Randomization is stratified for all participating centers .
METHODS	Conventional dual-chamber pacemakers with advanced home monitoring functionality will be implanted .
METHODS	The ventricular lead will be implanted in the right ventricular apex .
METHODS	The first three months of the 36-month follow-up period are considered as run-in time .
METHODS	During the pre-randomization visit and follow-up , an interview , electrocardiogram and pacemaker assessment will be performed , prescribed antiarrhythmic medication will be reviewed and patients will be asked to complete an SF-36 questionnaire .
METHODS	An echocardiographic examination will be conducted in the pre-randomization phase and at the end of each follow-up year .
METHODS	Home monitoring will be used to send daily reports in case of atrial fibrillation episodes .
CONCLUSIONS	This randomized controlled trial is the first in which home monitoring will be used to compare atrial fibrillation recurrences between pacing in the distal coronary sinus or right atrial appendage .
CONCLUSIONS	Home monitoring gives the opportunity to accurately detect atrial fibrillation episodes and to study characteristics of atrial fibrillation episodes .
CONCLUSIONS	Should distal coronary sinus pacing significantly diminish atrial fibrillation recurrences , this study will redefine the preferential location of an atrial lead for preventive pacing .
BACKGROUND	Current Controlled Trials ISRCTN65911661 , registered on 8 July 2013 .

###25249036
OBJECTIVE	Negative lifestyle factors are known to be associated with increased cardiovascular risk ( CVR ) in children , but research on their combined impact on a general population of children is sparse .
OBJECTIVE	Therefore , we aimed to quantify the combined impact of easily assessable negative lifestyle factors on the CVR scores of randomly selected children after 4 years .
METHODS	Of the 540 randomly selected 6 - to 13-year-old children , 502 children participated in a baseline health assessment , and 64 % were assessed again after 4 years .
METHODS	Measures included anthropometry , fasting blood samples , and a health assessment questionnaire .
METHODS	Participants scored one point for each negative lifestyle factor at baseline : overweight ; physical inactivity ; high media consumption ; little outdoor time ; skipping breakfast ; and having a parent who has ever smoked , is inactive , or overweight .
METHODS	A CVR score at follow-up was constructed by averaging sex - and age-related z-scores of waist circumference , blood pressure , glucose , inverted high-density lipoprotein , and triglycerides .
RESULTS	The age - , sex - , pubertal stage - , and social class-adjusted probabilities ( 95 % confidence interval ) for being in the highest CVR score tertile at follow-up for children who had at most one ( n = 48 ) , two ( n = 64 ) , three ( n = 56 ) , four ( n = 41 ) , or five or more ( n = 14 ) risky lifestyle factors were 15.4 % ( 8.9-25 .3 ) , 24.3 % ( 17.4-32 .8 ) , 36.0 % ( 28.6-44 .2 ) , 49.8 % ( 38.6-61 .0 ) , and 63.5 % ( 47.2-77 .2 ) , respectively .
CONCLUSIONS	Even in childhood , an accumulation of negative lifestyle factors is associated with higher CVR scores after 4 years .
CONCLUSIONS	These negative lifestyle factors are easy to assess in clinical practice and allow early detection and prevention of CVR in childhood .

###25285987
BACKGROUND	Transcranial direct current stimulation ( tDCS ) and auditory residual inhibition ( RI ) are short lasting non-invasive techniques that can suppress tinnitus in some people .
BACKGROUND	A pilot study was undertaken to evaluate methods to measure a potential additive effect of these treatments .
METHODS	Ten participants ( mean age 59 years ) with chronic tinnitus underwent four sessions of anodal tDCS of the left temporoparietal area ( LTA ) combined with 1min of auditory stimulation ( broadband noise presented at tinnitus minimum masking level [ MML ] +10 dB ) , either before , during or immediately after tDCS and in a sham controlled session .
METHODS	Participants continuously monitored and recorded their MML on custom software prior to stimulation , during 20 min of tDCS , and 30 min following tDCS .
METHODS	A tinnitus loudness rating was undertaken before and after completion of testing .
RESULTS	Nine out of ten participants completed the study , one participant dropped out after two sessions due to self-reported worsening in tinnitus symptoms .
RESULTS	Seven out of nine participants reported transient tinnitus suppression when sound stimulation was presented along with tDCS .
RESULTS	No reliable change in MML was observed .
CONCLUSIONS	This is the first study to examine the feasibility of continuously measuring MML while providing a combination of auditory and noninvasive brain stimulation simultaneously .
CONCLUSIONS	We propose modifications in the protocol used , to find ways to increase the duration of auditory RI and investigate its underlying mechanisms .
CONCLUSIONS	Recommendations for further research are discussed .

###24268564
OBJECTIVE	Apathy in the context of treated major depressive disorder ( MDD ) is a frequently observed phenomenon in clinical practice .
OBJECTIVE	This study aimed to assess the validity of the Rothschild Scale for Antidepressant Tachyphylaxis ( RSAT ) and the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire ( CPFQ ) for measuring apathy , and to assess the relationship between apathy and possible contributing factors , in patients with MDD and residual apathy in the absence of depressed mood .
METHODS	The underlying structure and validity of the RSAT and CPFQ were assessed via factor analysis and correlation with the Apathy Evaluation Scale-Clinician rated version ( AES-C ) in 483 patients who had previously responded to treatment with a selective serotonin reuptake inhibitor .
METHODS	The relationship between apathy and contributing variables was investigated via structural equation modeling .
METHODS	Correlation and regression analyses were conducted to examine the relationship between the Sheehan Disability Scale ( SDS ) and the RSAT , CPFQ , and AES-C .
RESULTS	The RSAT and CPFQ were validated with the AES-C with respect to energy and motivation .
RESULTS	The latent variable `` Energy and Interest '' , based on the energy , motivation , and interest items ( RSAT and CPFQ ) , was a major contributing factor to apathy .
RESULTS	Improvements in function ( SDS ) were significantly correlated with , and predicted by , improvements in apathy and cognitive and physical functioning ( assessed by the RSAT , CPFQ , and AES-C ) .
CONCLUSIONS	These analyses provide further information on apathy and its assessment in the context of treated MDD .
CONCLUSIONS	A better understanding of apathy will aid further investigation of this phenomenon and , ultimately , determination of the most appropriate approach for its clinical management .

###25458804
BACKGROUND	Caring for people with dementia in dementia special care units is a demanding job .
BACKGROUND	Challenging behaviour is one of the factors influencing the job satisfaction and burnout of care staff .
BACKGROUND	A care programme for the challenging behaviour of nursing home residents with dementia might , next to diminishing the challenging behaviour of residents , improve job satisfaction and reduce the care staff 's feelings of burnout .
OBJECTIVE	To determine the effects of a care programme for the challenging behaviour of nursing home residents with dementia on the burnout , job satisfaction and job demands of care staff .
METHODS	The care programme was implemented according to a stepped wedge design in which care units were randomly divided over five groups with different time points of starting with implementation .
METHODS	17 Dutch dementia special care units .
METHODS	Care staff members of the 17 units .
METHODS	The care programme consists of an education package and of various structured assessment tools that guide professionals through the multidisciplinary detection , analysis , treatment and evaluation of treatment of challenging behaviour .
METHODS	Burnout , job satisfaction and job demands were measured before implementation , halfway through the implementation process and after all the care units had implemented the care programme .
METHODS	Burnout was measured with the Dutch version of the Maslach burnout inventory ( UBOS-C , three subscales ) ; job satisfaction and job demands were measured with subscales of the Leiden Quality of Work Questionnaire .
METHODS	Mixed model analyses were used to determine effects .
METHODS	Care staff could not be blinded for the intervention .
RESULTS	Of the 1441 questionnaires , 645 were returned ( response 45 % , 318 control measurements , 327 intervention measurements ) by 380 unique care staff members .
RESULTS	Significant effects were found on job satisfaction ( 0.93 , 95 % CI 0.48-1 .38 ) .
RESULTS	On the other outcomes , no significant changes in the scores were found .
CONCLUSIONS	Positive effects of using the Grip on Challenging behaviour care programme were found on job satisfaction , without an increase in job demands .

###25103358
BACKGROUND	Novel strategies are required to increase school-based physical activity levels of children .
BACKGROUND	Integrating physical activity in mathematics lessons may lead to improvements in students ' physical activity levels as well as enjoyment , engagement and learning .
BACKGROUND	The primary aim of this study is to evaluate the impact of a curriculum-based physical activity integration program known as EASY Minds ( Encouraging Activity to Stimulate Young Minds ) on children 's daily school time physical activity levels .
BACKGROUND	Secondary aims include exploring the impact of EASY Minds on their engagement and ` on task ' behaviour in mathematics .
METHODS	Grade 5/6 classes from eight public schools in New South Wales , Australia will be randomly allocated to intervention ( n = 4 ) or control ( n = 4 ) groups .
METHODS	Teachers from the intervention group will receive one day of professional development , a resource pack and asked to adapt their lessons to embed movement-based learning in their daily mathematics program in at least three lessons per week over a six week period .
METHODS	Intervention support will be provided via a weekly email and three lesson observations .
METHODS	The primary outcomes will be children 's physical activity levels ( accelerometry ) across both the school day and during mathematics lessons ( moderate-to-vigorous physical activity and sedentary time ) .
METHODS	Children 's ` on-task ' behaviour , enjoyment of mathematics and mathematics attainment will be assessed as secondary outcomes .
METHODS	A detailed process evaluation will be undertaken .
CONCLUSIONS	EASY Minds is an innovative intervention that has the potential to improve key physical and academic outcomes for primary school aged children and help guide policy and practice regarding the teaching of mathematics .
BACKGROUND	Australian and New Zealand Clinical Trials Register ACTRN12613000637741 13/05/2013 .

###24921074
BACKGROUND	Daily diaries are a useful way of measuring fluctuations in pain-related symptoms .
BACKGROUND	However , traditional diaries do not assure the gathering of data in real time , not solving the problem of retrospective assessment .
BACKGROUND	Ecological momentary assessment ( EMA ) by means of electronic diaries helps to improve repeated assessment .
BACKGROUND	However , it is important to test its feasibility in specific populations in order to reach a wider number of people who could benefit from these procedures .
METHODS	The present study compares the compliance and acceptability of an electronic diary running on a smartphone using a crossover design for a sample with a specific pain condition , fibromyalgia and low familiarity with technology .
METHODS	Forty-seven participants were randomly assigned to one of two conditions : ( 1 ) paper diary - smartphone diary and ( 2 ) smartphone diary - paper diary , using each assessment method for 1 week .
RESULTS	The findings of this study showed that the smartphone diary made it possible to gather more accurate and complete ratings .
RESULTS	Besides , this method was well accepted by a sample of patients with fibromyalgia referred by a public hospital , with an important proportion of participants with low level of education and low familiarity with technology .
CONCLUSIONS	The findings of this study support the use of smartphones for EMA even in specific populations with a specific pain condition , fibromyalgia and with low familiarity with technology .
CONCLUSIONS	These methods could help clinicians and researchers to gather more accurate ratings of relevant pain-related variables even in populations with low familiarity with technology .

###24377218
OBJECTIVE	To compare the difference in the efficacy on post-stroke constipation between acupuncture therapy of regulating qi circulation of fe-organ and Shengxue Tongbian Capsules .
METHODS	Seventy-five patients of post-stroke constipation were randomized into an acupuncture group ( 39 cases ) and a Chinese medicine group ( 36 cases ) .
METHODS	The unit mode comprehensive therapy of stroke was adopted as basic treatment in the two groups .
METHODS	In the acupuncture group , acupuncture therapy of regulating qi circulation of fu-organ was added at Tianshu ( ST 25 ) , Zhigou ( TE 6 ) , Qihai ( CV 6 ) and Zusanli ( ST 36 ) , once every day .
METHODS	In the Chinese medicine group , Shengrue Tongbian Capsules were supplemented for oral administration , once every day , 10 g each time .
METHODS	The clinical symptom score of constipation was observed before treatment , after 1 and 2 weeks treatment in the two groups , respectively .
METHODS	The efficacy in 1 week and 2 weeks of treatment and the adverse reaction were observed .
RESULTS	In 1 and 2 weeks of treatment , the clinical symptom score of constipation was reduced significantly as compared with that before treatment in the two groups ( all P < 0.05 ) .
RESULTS	The improvements in the acupuncture group were significant than those in the Chinese medicine group in 2 weeks of treatment ( 8.03 + / - 2.38 vs 9.20 + / - 2.45 , P < 0.05 ) .
RESULTS	Concerning to the occurrence of adverse reaction , there was 1 case of local bruises in needling local site in the acupuncture group ; and there were 1 case of abdominal pain , 3 cases of diarrhea and 2 cases of nausea and vomiting in the Chinese medicine group .
CONCLUSIONS	Both the acupuncture therapy of regulating qi circulation of fu-organ and Shengxue Tongbian Capsules achieve the significant efficacy on post-stroke constipation .
CONCLUSIONS	The efficacy of the acupuncture therapy of regulating qi circulation of fe-organ is better and the adverse reaction is less after long-term persistent treatment .

###24722498
OBJECTIVE	Diabetes-associated autoantibodies can be detected in adult-onset diabetes , even when initially non-insulin requiring , i.e. , with latent autoimmune diabetes .
OBJECTIVE	We aimed to identify adult-onset autoimmune diabetes in patients with established `` type 2 diabetes '' participating in the Collaborative Atorvastatin Diabetes Study ( CARDS ) to characterize their phenotype and clinical outcome .
METHODS	We prospectively studied 2,425 European patients with presumed type 2 diabetes ( mean age 62 years , diabetes duration 7.9 years ) for outcomes at 3.9 years after randomization to either atorvastatin or placebo .
METHODS	Subjects were screened for autoantibodies to GAD ( GADA ) , insulinoma-associated antigen-2 ( IA-2A ) , and zinc-transporter 8 ( ZnT8A ) .
RESULTS	A total of 173 patients ( 7.1 % ) had GADA , of whom 11 ( 0.5 % ) and 5 ( 0.2 % ) were also positive for IA-2A and ZnT8A , respectively .
RESULTS	At baseline , 44 % of GADA-positive patients were not on insulin .
RESULTS	Fewer autoantibody-positive than autoantibody-negative patients had metabolic syndrome ( 64 vs. 80 % ) , and more were on insulin ( 56 vs. 17 % ) ( P < 0.0001 for each ) without lower HbA1c ( 69 mmol/mol [ 8.5 % ] vs. 62 mmol/mol [ 7.8 % ] ) .
RESULTS	The frequency of microvascular and macrovascular events was similar in both cohorts , independent of atorvastatin .
CONCLUSIONS	Adult-onset autoimmune diabetes was prevalent , even in patients with established diabetes presumed to have type 2 diabetes .
CONCLUSIONS	After 11.8 years ' diabetes duration , nearly half the patients with autoimmune diabetes were not on insulin treatment and almost two-thirds had metabolic syndrome .
CONCLUSIONS	The type of diabetes , whether autoimmune diabetes or type 2 diabetes , did not impact the risk of microvascular disease .

###25064721
OBJECTIVE	To compare the intraocular pressure ( IOP ) - lowering efficacy and safety of brinzolamide 1 % and brimonidine 0.2 % fixed combination ( BBFC ) with that of brinzolamide 1 % or brimonidine 0.2 % monotherapy , all dosed 2 times per day ( BID ) .
METHODS	Six-month , phase 3 , randomized , multicenter , double-masked clinical trial .
METHODS	A total of 560 patients with primary open-angle glaucoma or ocular hypertension who had insufficient IOP reduction with their current therapeutic regimen or who were receiving 2 IOP-lowering medications .
METHODS	Patients received BBFC ( n = 193 ) , brinzolamide 1 % ( n = 192 ) , or brimonidine 0.2 % ( n = 175 ) BID .
METHODS	The primary end point was mean change in diurnal IOP from baseline to month 3 .
METHODS	Supportive end points included mean diurnal IOP change from baseline at week 2 , week 6 , and month 6 ; and mean IOP , mean IOP change from baseline , mean percentage IOP change from baseline , and percentage of patients with IOP < 18 mmHg at week 2 , week 6 , month 3 , and month 6 at each assessment time point ( i.e. , 9 am , 11 am , and 4 pm ) .
METHODS	Adverse events were recorded throughout the study .
RESULTS	Baseline diurnal IOP was similar among groups ( mean standard deviation : BBFC , 25.9 0.19 mmHg ; brinzolamide , 25.9 0.20 mmHg ; brimonidine , 26.0 0.19 mmHg ) .
RESULTS	At month 3 , BBFC lowered mean diurnal IOP from baseline to a significantly greater extent than brinzolamide ( least squares [ LS ] mean difference : -1.4 mmHg ; P < 0.0001 ; t test ) and brimonidine ( LS mean difference : -1.5 mmHg ; P < 0.0001 ) .
RESULTS	All supportive end points corroborated the results of the primary efficacy analysis .
RESULTS	Mean percentage reductions in IOP from baseline were 26.7 % to 36.0 % with BBFC , 22.4 % to 27.9 % with brinzolamide , and 20.6 % to 31.3 % with brimonidine .
RESULTS	The most common adverse drug reactions were ocular side effects , including hyperemia , blurred vision , allergic-type reactions , and discomfort .
RESULTS	The incidence of hyperemia of the eye was slightly lower with brinzolamide than with BBFC and brimonidine , whereas blurred vision and ocular discomfort were slightly more common with BBFC than with brinzolamide or brimonidine .
CONCLUSIONS	Brinzolamide 1 % and brimonidine 0.2 % fixed combination administered BID had a significantly greater IOP-lowering effect than either brinzolamide or brimonidine alone and displayed a safety profile consistent with its individual components .

###24571824
BACKGROUND	Femoroacetabular impingement is a common cause of hip/groin symptoms and impaired functional performance in younger sporting populations and results from morphological abnormalities of the hip in which the proximal femur abuts against the acetabular rim .
BACKGROUND	Many people with symptomatic femoroacetabular impingement undergo arthroscopic hip surgery to correct the bony abnormalities .
BACKGROUND	While many case series over the past decade have reported favourable surgical outcomes , it is not known whether formal rehabilitation is needed as part of the management of patients undergoing this surgical procedure .
BACKGROUND	This randomised controlled trial will investigate the efficacy of a progressive physiotherapist-supervised rehabilitation program ( Takla-O'Donnell Protocol ) in improving health-related quality of life , physical function and symptoms in individuals undergoing arthroscopic management of femoroacetabular impingement .
METHODS	100 people aged 16-35 years undergoing hip arthroscopy for symptomatic femoroacetabular impingement will be recruited from surgical practices in Melbourne , Australia and randomly allocated to either a physiotherapy or control group .
METHODS	Both groups will receive written information and one standardised post-operative physiotherapy visit whilst in hospital as per usual care .
METHODS	Those in the physiotherapy group will also receive seven individual 30-minute physiotherapy sessions , including one pre-operative visit ( within 2 weeks of surgery ) and six post-operative visits at fortnightly intervals ( commencing two weeks after surgery ) .
METHODS	The physiotherapy intervention will incorporate education and advice , manual techniques and prescription of a progressive rehabilitation program including home , aquatic and gym exercises .
METHODS	The control group will not receive additional physiotherapy management .
METHODS	Measurements will be taken at baseline ( 2 weeks pre-operatively ) and at 14 and 24 weeks post-surgery .
METHODS	Primary outcomes are the International Hip Outcome Tool and the sports subscale of the Hip Outcome Score at 14 weeks post-surgery .
METHODS	Secondary outcomes include the Copenhagen Hip and Groin Outcome Score , the activities of daily living subscale of the Hip Outcome Score , the Heidelberg Sports Activity Score , a modified Tegner Activity Scale and participant-perceived overall change .
CONCLUSIONS	The findings from this randomised controlled trial will provide evidence for the efficacy of a specific physiotherapist-supervised rehabilitation program in improving outcomes following arthroscopic management of symptomatic femoroacetabular impingement .
BACKGROUND	Australian New Zealand Clinical Trials Registry reference number : ACTRN12613000282785 .

###24318788
OBJECTIVE	Injury prevention effects of neuromuscular training have been partly attributed to postural control adaptations .
OBJECTIVE	Uncertainty exists regarding the magnitude of these adaptations and on how they can be adequately monitored .
OBJECTIVE	The objective was to determine the time course of neuromuscular training effects on functional , dynamic and static balance measures .
METHODS	Thirty youth ( 14.9 3 years ) field hockey athletes were randomised to an intervention or control group .
METHODS	The intervention included a 20-min neuromuscular warm-up program performed twice weekly for 10 weeks .
METHODS	Balance assessments were performed at baseline , week three , week six and post-intervention .
METHODS	They included the star excursion balance test ( SEBT ) , balance error scoring system ( BESS ) , jump-landing time to stabilization ( TTS ) and center of pressure ( COP ) sway velocity during single-leg standing .
RESULTS	No baseline differences were found between groups in demographic data and balance measures .
RESULTS	Adherence was at 86 % .
RESULTS	All balance measures except the medial-lateral TTS improved significantly over time ( p < 0.05 ) in both groups .
RESULTS	Significant group by time interactions were found for the BESS score ( p < 0.001 ) .
RESULTS	The intervention group showed greater improvements ( 69.3 10.3 % ) after 10 weeks in comparison to controls ( 31.8 22.1 % ) .
RESULTS	There were no significant group by time interactions in the SEBT , TTS and COP sway velocity .
CONCLUSIONS	Neuromuscular training was effective in improving postural control in youth team athletes .
CONCLUSIONS	However , this effect was not reflected in all balance measures suggesting that the neuromuscular training did not influence all dimensions of postural control .
CONCLUSIONS	Further studies are needed to confirm the potential of specific warm-up programs to improve postural control .

###25601535
OBJECTIVE	To evaluate the effect of monthly intravitreal ranibizumab on hard exudate ( HE ) area and the impact of HE on visual acuity ( VA ) outcomes in diabetic macular edema ( DME ) patients using data from 2 phase III clinical trials .
METHODS	Exploratory analyses of phase III , randomized , double-masked , sham-controlled , multicenter clinical trials .
METHODS	Adults with DME , baseline best-corrected VA 20/40 to 20/320 Snellen equivalent , and central foveal thickness of 275 m.
METHODS	Between the 2 studies , 759 patients with DME were randomized to receive monthly 0.3 or 0.5 mg intravitreal ranibizumab ( Lucentis ; Genentech , Inc. , South San Francisco , CA ) or sham injections .
METHODS	Hard exudate area was assessed from color fundus stereophotographs both on an ordinal scale and using continuous estimates of areas within the Early Treatment Diabetic Retinopathy Study grid .
RESULTS	Data from 739 eyes were available for analysis .
RESULTS	Mean baseline HE area was similar across treatment groups , ranging from 0.65 to 0.82 mm ( 2 ) .
RESULTS	Through month 24 , the percentage of eyes without HE increased from 20.9 % to 36.3 % in the sham group and from 22.1 % to 61.3 % and 23.6 % to 62.0 % in the ranibizumab 0.3-mg and 0.5-mg groups , respectively .
RESULTS	Resolution of HE became apparent sometime after month 6 in ranibizumab-treated eyes .
RESULTS	At baseline , there was no meaningful correlation between VA and presence or absence of HE .
RESULTS	After baseline , there also was no consistent correlation between presence or absence of HE and change in VA over time .
CONCLUSIONS	In this exploratory analysis , monthly intravitreal ranibizumab resulted in significantly greater reduction of HE area compared with sham ( P < 0.0001 ) .
CONCLUSIONS	In contrast to the rapid effects of ranibizumab on macular edema , changes in HE area were more gradual .
CONCLUSIONS	Contrary to prior expectations , the presence and area of HE did not increase as DME resolved ( either in the ranibizumab or sham groups ) .
CONCLUSIONS	Importantly , baseline VA was not correlated with presence of HE , nor was the therapeutic benefit of ranibizumab on VA affected negatively by the presence of HE .
CONCLUSIONS	These data suggest that in the context of intravitreal anti-vascular endothelial growth factor therapy , the presence of HE is not a prognostic indicator of poor visual outcomes .

###24823925
OBJECTIVE	This study aims to assess the extent to which accelerometers can be used to determine the effect of robot-supported task-oriented arm-hand training , relative to task-oriented arm-hand training alone , on the actual amount of arm-hand use of chronic stroke patients in their home situation .
METHODS	This single-blind randomized controlled trial included 16 chronic stroke patients , randomly allocated using blocked randomization ( n = 2 ) to receive task-oriented robot-supported arm-hand training or task-oriented ( unsupported ) arm-hand training .
METHODS	Training lasted 8 weeks , 4 times/week , 2 30 min/day using the ( T - ) TOAT ( ( Technology-supported ) - Task-Oriented-Arm-Training ) method .
METHODS	The actual amount of arm-hand use , was assessed at baseline , after 8 weeks training and 6 months after training cessation .
METHODS	Duration of use and intensity of use of the affected arm-hand during unimanual and bimanual activities were calculated .
RESULTS	Duration and intensity of use of the affected arm-hand did not change significantly during and after training , with or without robot-support ( i.e. duration of use of unimanual use of the affected arm-hand : median difference of -0.17 % in the robot-group and -0.08 % in the control group between baseline and after training cessation ; intensity of the affected arm-hand : median difference of 3.95 % in the robot-group and 3.32 % in the control group between baseline and after training cessation ) .
RESULTS	No significant between-group differences were found .
CONCLUSIONS	Accelerometer data did not show significant changes in actual amount of arm-hand use after task-oriented training , with or without robot-support .
CONCLUSIONS	Next to the amount of use , discrimination between activities performed and information about quality of use of the affected arm-hand are essential to determine actual arm-hand performance .
BACKGROUND	Controlled-trials .
BACKGROUND	com ISRCTN82787126 .

###24923623
BACKGROUND	Cancer survivorship rates have increased in developed countries largely due to population ageing and improvements in cancer care .
BACKGROUND	Survivorship is a neglected phase of cancer treatment and is often associated with adverse physical and psychological effects .
BACKGROUND	There is a need for broadly accessible , non-pharmacological measures that may prolong disease-free survival , reduce or alleviate co-morbidities and enhance quality of life .
BACKGROUND	The aim of the Steps TowaRd Improving Diet and Exercise ( STRIDE ) study is to evaluate the effectiveness of an online-delivered physical activity intervention for increasing walking in cancer survivors living in metropolitan and rural areas of South Australia .
METHODS	This is a quasi-randomised controlled trial .
METHODS	The intervention period is 12-weeks with 3-month follow-up .
METHODS	The trial will be conducted at a university setting and community health services in South Australia .
METHODS	Participants will be insufficiently active and aged 18 years or older .
METHODS	Participants will be randomly assigned to either the intervention or control group .
METHODS	All participants will receive a pedometer but only the intervention group will have access to the STRIDE website where they will report steps , affect and ratings of perceived exertion ( RPE ) during exercise daily .
METHODS	Researchers will use these variables to individualise weekly step goals to increase walking.The primary outcome measure is steps per day .
METHODS	The secondary outcomes are a ) health measures ( anthropometric and physiological ) , b ) dietary habits ( consumption of core foods and non-core foods ) and c ) quality of life ( QOL ) including physical , psychological and social wellbeing .
METHODS	Measures will be collected at baseline , post-intervention and 3-month follow-up .
CONCLUSIONS	This protocol describes the implementation of a trial using an online resource to assist cancer survivors to become more physically active .
CONCLUSIONS	It is an innovative tool that uses ratings of perceived exertion and daily affect to create individualised step goals for cancer survivors .
CONCLUSIONS	The research findings may be of relevance to public health policy makers as an efficacious and inexpensive online-delivered intervention can have widespread application and may improve physical and psychological outcomes among this vulnerable population .
CONCLUSIONS	Findings may indicate directions for the implementation of future physical activity interventions with this population .
BACKGROUND	Australian New Zealand Clinical Trials Registry : ACTRN12613000473763 .

###24247559
OBJECTIVE	It was the aim of this study to evaluate maintenance therapy with bevacizumab + capecitabine following induction with bevacizumab + capecitabine + oxaliplatin ( XELOX ) versus bevacizumab + XELOX until progression as first-line therapy in metastatic colorectal cancer ( mCRC ) .
METHODS	Patients received either bevacizumab ( 7.5 mg/kg ) + XELOX ( capecitabine 1,000 mg/m ( 2 ) twice daily on days 1-14 + oxaliplatin 130 mg/m ( 2 ) on day 1 every 3 weeks ) until disease progression ( arm A ) or the same doses of bevacizumab + XELOX for 6 cycles followed by bevacizumab + capecitabine until disease progression ( arm B ) .
METHODS	The primary endpoint was progression-free survival ( PFS ) ; secondary endpoints included overall survival ( OS ) , objective response rate ( ORR ) and safety .
RESULTS	One hundred and twenty-three patients were randomized .
RESULTS	Treatment compliance was similar in both groups .
RESULTS	Median PFS was significantly longer for arm B than for arm A ( 11.0 vs. 8.3 months ; p = 0.002 ) .
RESULTS	There was no significant difference between the two arms for ORR ( 66.7 vs. 59.0 % ; p = 0.861 ) or median OS ( 23.8 vs. 20.2 months ; p = 0.100 ) .
RESULTS	Tolerability was acceptable in both treatment arms ; the most frequent grade 3/4 treatment-related adverse events ( arm B vs. arm A ) were fatigue ( 6.6 vs. 16.1 % ) , diarrhoea ( 3.3 vs. 11.3 % ) , anorexia ( 3.3 vs. 11.3 % ) , and neuropathy ( 1.6 vs. 8.1 % ) .
CONCLUSIONS	Maintenance therapy with bevacizumab + capecitabine can be considered an appropriate option following induction bevacizumab + XELOX in patients with mCRC instead of continuation of bevacizumab + XELOX .

###24374517
OBJECTIVE	The aim of the present study was to compare the frequency of readmissions due to small bowel obstruction ( SBO ) after open versus laparoscopic surgery performed for suspected acute appendicitis .
BACKGROUND	Appendicitis is a common disease , with a lifetime risk of approximately 7 % .
BACKGROUND	Appendectomy is the treatment of choice for most patients .
BACKGROUND	Postoperative adhesions are common after abdominal surgery , including appendectomy .
METHODS	Consecutive patients , 16 years or older , operated on because of suspected appendicitis at 2 university hospitals between 1992 and 2007 were included .
METHODS	The prime approach was open at one hospital and laparoscopic at the other hospital .
METHODS	Open and laparoscopic procedures were compared retrospectively , reviewing the patients ' charts until the middle of 2012 .
METHODS	Hospitalization for SBO after index surgery was registered .
RESULTS	A total of 2333 patients in the open group and 2372 patients in the laparoscopic group were included .
RESULTS	The frequency of hospitalization for SBO was low in both groups , although a difference between the groups was identified ( 1.0 % in the open group and 0.4 % in the laparoscopic group ) ( P = 0.015 ) .
CONCLUSIONS	Hospitalization due to SBO , between open and laparoscopic procedures , in patients operated on because of suspected appendicitis demonstrated a significant difference , favoring the laparoscopic approach .
CONCLUSIONS	The frequency of SBO after the index surgery was , though , low in both groups .

###25005652
OBJECTIVE	Behavioral approaches and pharmacotherapy are of proven benefit in assisting smokers to quit , but it is unclear whether combining nicotine replacement therapy ( NRT ) with varenicline to improve abstinence is effective and safe .
OBJECTIVE	To evaluate the efficacy and safety of combining varenicline and a nicotine patch vs varenicline alone in smoking cessation .
METHODS	Randomized , blinded , placebo-controlled clinical trial with a 12-week treatment period and a further 12-week follow-up conducted in 7 centers in South Africa from April 2011 to October 2012 .
METHODS	Four hundred forty-six generally healthy smokers were randomized ( 1:1 ) ; 435 were included in the efficacy and safety analyses .
METHODS	Nicotine or placebo patch treatment began 2 weeks before a target quit date ( TQD ) and continued for a further 12 weeks .
METHODS	Varenicline was begun 1 week prior to TQD , continued for a further 12 weeks , and tapered off during week 13 .
METHODS	Tobacco abstinence was established and confirmed by exhaled carbon monoxide measurements at TQD and at intervals thereafter up to 24 weeks .
METHODS	The primary end point was the 4-week exhaled carbon monoxide-confirmed continuous abstinence rate for weeks 9 through 12 of treatment , ie , the proportion of participants able to maintain complete abstinence from smoking for the last 4 weeks of treatment , as assessed using multiple imputation analysis .
METHODS	Secondary end points included point prevalence abstinence at 6 months , continuous abstinence rate from weeks 9 through 24 , and adverse events .
METHODS	Multiple imputation also was used to address loss to follow-up .
RESULTS	The combination treatment was associated with a higher continuous abstinence rate at 12 weeks ( 55.4 % vs 40.9 % ; odds ratio [ OR ] , 1.85 ; 95 % CI , 1.19-2 .89 ; P = .007 ) and 24 weeks ( 49.0 % vs 32.6 % ; OR , 1.98 ; 95 % CI , 1.25-3 .14 ; P = .004 ) and point prevalence abstinence rate at 6 months ( 65.1 % vs 46.7 % ; OR , 2.13 ; 95 % CI , 1.32-3 .43 ; P = .002 ) .
RESULTS	In the combination treatment group , there was a numerically greater incidence of nausea , sleep disturbance , skin reactions , constipation , and depression , with only skin reactions reaching statistical significance ( 14.4 % vs 7.8 % ; P = .03 ) ; the varenicline-alone group experienced more abnormal dreams and headaches .
CONCLUSIONS	Varenicline in combination with NRT was more effective than varenicline alone at achieving tobacco abstinence at 12 weeks ( end of treatment ) and at 6 months .
CONCLUSIONS	Further studies are needed to assess long-term efficacy and safety .
BACKGROUND	clinicaltrials.gov Identifier : NCT01444131 .

###24825371
BACKGROUND	Intensive care unit ( ICU ) - acquired weakness is a frequent complication of critical illness .
BACKGROUND	It is unclear whether it is a marker or mediator of poor outcomes .
OBJECTIVE	To determine acute outcomes , 1-year mortality , and costs of ICU-acquired weakness among long-stay ( 8 d ) ICU patients and to assess the impact of recovery of weakness at ICU discharge .
METHODS	Data were prospectively collected during a randomized controlled trial .
METHODS	Impact of weakness on outcomes and costs was analyzed with a one-to-one propensity-score-matching for baseline characteristics , illness severity , and risk factor exposure before assessment .
METHODS	Among weak patients , impact of persistent weakness at ICU discharge on risk of death after 1 year was examined with multivariable Cox proportional hazards analysis .
RESULTS	A total of 78.6 % were admitted to the surgical ICU ; 227 of 415 ( 55 % ) long-stay assessable ICU patients were weak ; 122 weak patients were matched to 122 not-weak patients .
RESULTS	As compared with matched not-weak patients , weak patients had a lower likelihood for live weaning from mechanical ventilation ( hazard ratio [ HR ] , 0.709 [ 0.549-0 .888 ] ; P = 0.009 ) , live ICU ( HR , 0.698 [ 0.553-0 .861 ] ; P = 0.008 ) and hospital discharge ( HR , 0.680 [ 0.514-0 .871 ] ; P = 0.007 ) .
RESULTS	In-hospital costs per patient ( +30.5 % , +5,443 Euro per patient ; P = 0.04 ) and 1-year mortality ( 30.6 % vs. 17.2 % ; P = 0.015 ) were also higher .
RESULTS	The 105 of 227 ( 46 % ) weak patients not matchable to not-weak patients had even worse prognosis and higher costs .
RESULTS	The 1-year risk of death was further increased if weakness persisted and was more severe as compared with recovery of weakness at ICU discharge ( P < 0.001 ) .
CONCLUSIONS	After careful matching the data suggest that ICU-acquired weakness worsens acute morbidity and increases healthcare-related costs and 1-year mortality .
CONCLUSIONS	Persistence and severity of weakness at ICU discharge further increased 1-year mortality .
CONCLUSIONS	Clinical trial registered with www.clinicaltrials.gov ( NCT 00512122 ) .

###25079920
OBJECTIVE	As parents of young children are often unaware their child is overweight , screening provides the opportunity to inform parents and provide the impetus for behaviour change .
OBJECTIVE	We aimed to determine if parents could recall and understand the information they received about their overweight child after weight screening .
METHODS	Randomised controlled trial of different methods of feedback .
METHODS	Participants were recruited through primary and secondary care but appointments took place at a University research clinic .
METHODS	1093 children aged 4-8years were screened .
METHODS	Only overweight children ( n = 271 , 24.7 % ) are included in this study .
METHODS	Parents of overweight children were randomised to receive feedback regarding their child 's weight using best practice care ( BPC ) or motivational interviewing ( MI ) at face-to-face interviews typically lasting 20-40min .
METHODS	244 ( 90 % ) parents participated in a follow-up interview 2weeks later to assess recall and understanding of information from the feedback session .
METHODS	Interviews were audio-taped and transcribed verbatim before coding for amount and accuracy of recall .
METHODS	Scores were calculated for total recall and sub-categories of interest .
RESULTS	Overall , 39 % of the information was recalled ( mean score 6.3 from possible score of 16 ) .
RESULTS	Parents given feedback via BPC recalled more than those in the MI group ( difference in total score 0.48 ; 95 % CI 0.05 to 0.92 ) .
RESULTS	Although 94 % of parents were able to correctly recall their child 's weight status , fewer than 10 parents could accurately describe what the measurements meant .
RESULTS	Maternal education ( 0.81 ; 0.25 to 1.37 ) and parental ratings of how useful they found the information ( 0.19 ; 0.04 to 0.35 ) were significant predictors of recall score in multivariate analyses .
CONCLUSIONS	While parents remember that their child 's body mass index is higher than recommended , they are unable to remember much of the information and advice provided about the result .
BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12609000749202 .

###24434091
OBJECTIVE	The limitations of antipsychotic therapy in schizophrenia and schizoaffective disorder led to the investigation of the putative utility of pharmacologic augmentation strategies .
OBJECTIVE	The antitumor agent bexarotene via nuclear retinoid X receptor ( RXR ) activation might modulate numerous metabolic pathways involved in the pathogenesis of schizophrenia and schizoaffective disorder .
OBJECTIVE	This trial aimed to investigate efficacy and safety of add-on bexarotene to ongoing antipsychotic treatment of patients with schizophrenia or schizoaffective disorder .
METHODS	Ninety inpatients and outpatients that met DSM-IV-TR criteria for schizophrenia or schizoaffective disorder participated in a 6-week , double-blind , randomized , placebo-controlled multicenter study .
METHODS	Bexarotene ( 75 mg/d ) was added to ongoing antipsychotic treatment from October 2008 to December 2010 .
METHODS	The reduction in the severity of symptoms on the Positive and Negative Syndrome Scale ( PANSS ) was a primary outcome .
METHODS	Secondary outcomes included general functioning , quality of life , and side effect scales .
RESULTS	Seventy-nine participants ( 88 % ) completed the protocol .
RESULTS	Controlling for antipsychotic agents , a mixed model showed that patients who received adjunctive bexarotene had significantly lower PANSS positive scale scores compared to patients who received placebo ( F = 8.6 , P = .003 ; treatment arms time , F = 2.7 , P = .049 ) , with moderate effect size ( d = 0.48 ; 95 % CI,0.04-0 .93 ) .
RESULTS	Patients with mean or higher baseline PANSS positive scale scores and patients who did not take lipid-reducing agents revealed greater amelioration of positive symptoms ( F = 7.4 , P = .008 ) .
RESULTS	Other symptoms and secondary outcome measures were not affected by adjunctive bexarotene .
RESULTS	Bexarotene was well tolerated , though 2 reversible side effects were reported : a significant increase in total cholesterol levels ( P < .001 ) and a decrease in total thyroxine levels ( P < .001 ) .
CONCLUSIONS	Bexarotene might potentially be a novel adjuvant therapeutic strategy for schizophrenia , particularly for the reduction of positive symptoms .
CONCLUSIONS	The potential benefits and risks of ongoing administration of bexarotene warrant further evaluation .
BACKGROUND	ClinicalTrials.gov identifier : NCT00535574 .

###24251361
BACKGROUND	The clinical utility of genotype-guided ( pharmacogenetically based ) dosing of warfarin has been tested only in small clinical trials or observational studies , with equivocal results .
METHODS	We randomly assigned 1015 patients to receive doses of warfarin during the first 5 days of therapy that were determined according to a dosing algorithm that included both clinical variables and genotype data or to one that included clinical variables only .
METHODS	All patients and clinicians were unaware of the dose of warfarin during the first 4 weeks of therapy .
METHODS	The primary outcome was the percentage of time that the international normalized ratio ( INR ) was in the therapeutic range from day 4 or 5 through day 28 of therapy .
RESULTS	At 4 weeks , the mean percentage of time in the therapeutic range was 45.2 % in the genotype-guided group and 45.4 % in the clinically guided group ( adjusted mean difference , [ genotype-guided group minus clinically guided group ] , -0.2 ; 95 % confidence interval , -3.4 to 3.1 ; P = 0.91 ) .
RESULTS	There also was no significant between-group difference among patients with a predicted dose difference between the two algorithms of 1 mg per day or more .
RESULTS	There was , however , a significant interaction between dosing strategy and race ( P = 0.003 ) .
RESULTS	Among black patients , the mean percentage of time in the therapeutic range was less in the genotype-guided group than in the clinically guided group .
RESULTS	The rates of the combined outcome of any INR of 4 or more , major bleeding , or thromboembolism did not differ significantly according to dosing strategy .
CONCLUSIONS	Genotype-guided dosing of warfarin did not improve anticoagulation control during the first 4 weeks of therapy .
CONCLUSIONS	( Funded by the National Heart , Lung , and Blood Institute and others ; COAG ClinicalTrials.gov number , NCT00839657 . )

###25329821
BACKGROUND	Calcium supplements are widely used among older adults for osteoporosis prevention and treatment .
BACKGROUND	However , their effect on creatinine levels and kidney function has not been well studied .
METHODS	We investigated the effect of calcium supplementation on blood creatinine concentration in a randomized controlled trial of colorectal adenoma chemoprevention conducted between 2004-2013 at 11 clinical centers in the United States .
METHODS	Healthy participants ( N = 1,675 ) aged 45-75 with a history of colorectal adenoma were assigned to daily supplementation with calcium ( 1200 mg , as carbonate ) , vitamin D3 ( 1000 IU ) , both , or placebo for three or five years .
METHODS	Changes in blood creatinine and total calcium concentration were measured after one year of treatment and multiple linear regression was used to estimate effects on creatinine concentrations .
RESULTS	After one year of treatment , blood creatinine was 0.0130.006 mg/dL higher on average among participants randomized to calcium compared to placebo after adjustment for other determinants of creatinine ( P = 0.03 ) .
RESULTS	However , the effect of calcium treatment appeared to be larger among participants who consumed the most alcohol ( 2-6 drinks/day ) or whose estimated glomerular filtration rate ( eGFR ) was less than 60 ml/min/1 .73 m2 at baseline .
RESULTS	The effect of calcium treatment on creatinine was only partially mediated by a concomitant increase in blood total calcium concentration and was independent of randomized vitamin D treatment .
RESULTS	There did not appear to be further increases in creatinine after the first year of calcium treatment .
CONCLUSIONS	Among healthy adults participating in a randomized clinical trial , daily supplementation with 1200 mg of elemental calcium caused a small increase in blood creatinine .
CONCLUSIONS	If confirmed , this finding may have implications for clinical and public health recommendations for calcium supplementation .
BACKGROUND	ClinicalTrials.gov NCT00153816 .

###25889066
BACKGROUND	Example-based learning using worked examples can foster clinical reasoning .
BACKGROUND	Worked examples are instructional tools that learners can use to study the steps needed to solve a problem .
BACKGROUND	Studying worked examples paired with completion examples promotes acquisition of problem-solving skills more than studying worked examples alone .
BACKGROUND	Completion examples are worked examples in which some of the solution steps remain unsolved for learners to complete .
BACKGROUND	Providing learners engaged in example-based learning with self-explanation prompts has been shown to foster increased meaningful learning compared to providing no self-explanation prompts .
BACKGROUND	Concept mapping and concept map study are other instructional activities known to promote meaningful learning .
BACKGROUND	This study compares the effects of self-explaining , completing a concept map and studying a concept map on conceptual knowledge and problem-solving skills among novice learners engaged in example-based learning .
METHODS	Ninety-one physiotherapy students were randomized into three conditions .
METHODS	They performed a pre-test and a post-test to evaluate their gains in conceptual knowledge and problem-solving skills ( transfer performance ) in intervention selection .
METHODS	They studied three pairs of worked/completion examples in a digital learning environment .
METHODS	Worked examples consisted of a written reasoning process for selecting an optimal physiotherapy intervention for a patient .
METHODS	The completion examples were partially worked out , with the last few problem-solving steps left blank for students to complete .
METHODS	The students then had to engage in additional self-explanation , concept map completion or model concept map study in order to synthesize and deepen their knowledge of the key concepts and problem-solving steps .
RESULTS	Pre-test performance did not differ among conditions .
RESULTS	Post-test conceptual knowledge was higher ( P < .001 ) in the concept map study condition ( 68.821.8 % ) compared to the concept map completion ( 52.817.0 % ) and self-explanation ( 52.221.7 % ) conditions .
RESULTS	Post-test problem-solving performance was higher ( P < .05 ) in the self-explanation ( 63.216.0 % ) condition compared to the concept map study ( 53.316.4 % ) and concept map completion ( 51.013.6 % ) conditions .
RESULTS	Students in the self-explanation condition also invested less mental effort in the post-test .
CONCLUSIONS	Studying model concept maps led to greater conceptual knowledge , whereas self-explanation led to higher transfer performance .
CONCLUSIONS	Self-explanation and concept map study can be combined with worked example and completion example strategies to foster intervention selection .

###24469138
OBJECTIVE	To evaluate the effectiveness and safety of nitrous oxide/oxygen inhalation sedation in the treatment of acute pulpitis .
METHODS	The study population comprised 72 patients of acute pulpitis treated from September 2012 to March 2013 .
METHODS	They were randomly divided into 2 groups , which included experimental group ( 37 cases ) and control group ( 35 cases ) .
METHODS	Venham clinical anxiety , cooperative behavior level and WHO clinical pain level evaluation were conducted for the patients .
METHODS	Wilcoxon and Chi-square test were used respectively for statistical analysis with SPSS 14.0 software package .
RESULTS	In the experimental group , 86.5 % cases behaved comfortable , while in the control group the rate was only 42.9 % .
RESULTS	94.6 % of the patients in the experimental group felt painless after therapy .
RESULTS	The proportion of that in the control group was 68.6 % .
RESULTS	There was significant difference between the 2 groups ( P < 0.01 ) .
CONCLUSIONS	The technique of nitrous oxide/oxygen inhalation sedation provides a safe and effective way to release pain and anxiety during treatment of acute pulpitis , while the long-term clinical result still needs further investigation .

###24660580
OBJECTIVE	To observe the influence of moxibustion temperature on blood lipids , endothelin-1 ( ET-1 ) , nitric oxide ( NO ) , and ET-1 / NO in hyperlipidemia patients .
METHODS	Forty-two primary hyperlipidemia patients were randomly divided into two groups of 21 and treated with moxibustion at different temperatures .
METHODS	Moxibustion was performed with the moxa roll 2.5-3 .0 cm from the skin in the treatment group and 4 cm in the control group , 10 min per point , once every other day .
METHODS	Skin temperature was precisely measured with a thermometer during moxibustion .
METHODS	After a 12-week treatment , seven measurements of blood lipids , ET-1 , and NO were recorded .
RESULTS	Total cholesterol and triglyceride , were lower in the treatment group than in the control group ( P < 0.05 ) .
RESULTS	Serum ET-1 and ET-1 / NO was obviously lowered in the treatment group ( P < 0.001 ) .
RESULTS	Moxibustion regulated NO and ET-1 / NO in the treatment group much better than in the control group .
CONCLUSIONS	Moxibustion can regulate blood lipids and clear blood vessels .
CONCLUSIONS	Moxibustion at 45 degrees C has a better effect than moxibustion at 38 degrees C on regulating blood lipids and protecting vascular endothelial function , indicating that suitable temperature influences the curative effect of moxibustion .

###25656287
BACKGROUND	In 2007 , we began the randomised phase 3 multicentre HYPRO trial to investigate the effect of hypofractionated radiotherapy compared with conventionally fractionated radiotherapy on relapse-free survival in patients with prostate cancer .
BACKGROUND	Here , we examine whether patients experience differences in acute gastrointestinal and genitourinary adverse effects .
METHODS	In this randomised non-inferiority phase 3 trial , done in seven radiotherapy centres in the Netherlands , we enrolled intermediate-risk or high-risk patients aged between 44 and 85 years with histologically confirmed stage T1b-T4 NX-0MX-0 prostate cancer , a PSA concentration of 60 ng/mL or lower , and WHO performance status of 0-2 .
METHODS	A web-based application was used to randomly assign ( 1:1 ) patients to receive either standard fractionation with 39 fractions of 2 Gy in 8 weeks ( five fractions per week ) or hypofractionation with 19 fractions of 34 Gy in 65 weeks ( three fractions per week ) .
METHODS	Randomisation was done with minimisation procedure , stratified by treatment centre and risk group .
METHODS	The primary endpoint is 5-year relapse-free survival .
METHODS	Here we report data for the acute toxicity outcomes : the cumulative incidence of grade 2 or worse acute and late genitourinary and gastrointestinal toxicity .
METHODS	Non-inferiority of hypofractionation was tested separately for genitourinary and gastrointestinal acute toxic effects , with a null hypothesis that cumulative incidences of each type of adverse event were not more than 8 % higher in the hypofractionation group than in the standard fractionation group .
METHODS	We scored acute genitourinary and gastrointestinal toxic effects according to RTOG-EORTC criteria from both case report forms and patients ' self-assessment questionnaires , at baseline , twice during radiotherapy , and 3 months after completion of radiotherapy .
METHODS	Analyses were done in the intention-to-treat population .
METHODS	Patient recruitment has been completed .
METHODS	This study is registered with www.controlled-trials.com , number ISRCTN85138529 .
RESULTS	Between March 19 , 2007 , and Dec 3 , 2010 , 820 patients were randomly assigned to treatment with standard fractionation ( n = 410 ) or hypofractionation ( n = 410 ) .
RESULTS	3 months after radiotherapy , 73 ( 22 % ) patients in the standard fractionation group and 75 ( 23 % ) patients in the hypofractionation group reported grade 2 or worse genitourinary toxicity ; grade 2 or worse gastrointestinal toxicity was noted in 43 ( 13 % ) patients in the standard fractionation group and in 42 ( 13 % ) in the hypofractionation group .
RESULTS	Grade 4 acute genitourinary toxicity was reported for two patients , one ( < 1 % ) in each group .
RESULTS	No grade 4 acute gastrointestinal toxicities were observed .
RESULTS	We noted no significant difference in cumulative incidence by 120 days after radiotherapy of grade 2 or worse acute genitourinary toxicity ( 578 % [ 95 % CI 529-627 ] in the standard fractionation group vs 605 % ( 558-653 ) in the hypofractionation group ; difference 27 % , 90 % CI -299 to 848 ; odds ratio [ OR ] 112 , 95 % CI 084-149 ; p = 043 ) .
RESULTS	The cumulative incidence of grade 2 or worse acute gastrointestinal toxicity by 120 days after radiotherapy was higher in patients given hypofractionation ( 312 % [ 95 % CI 266-358 ] in the standard fractionation group vs 420 % [ 372-469 ] in the hypofractionation group ; difference 108 % , 90 % CI 525-1643 ; OR 16 ; p = 00015 ; non-inferiority not confirmed ) .
CONCLUSIONS	Hypofractionated radiotherapy was not non-inferior to standard fractionated radiotherapy in terms of acute genitourinary and gastrointestinal toxicity for men with intermediate-risk and high-risk prostate cancer .
CONCLUSIONS	In fact , the cumulative incidence of grade 2 or worse acute gastrointestinal toxicity was significantly higher in patients given hypofractionation than in those given standard fractionated radiotherapy .
CONCLUSIONS	Patients remain in follow-up for efficacy endpoints .
BACKGROUND	The Dutch Cancer Society .

###24366792
OBJECTIVE	To compare the outcome in patients who underwent surgery for unstable intertrochanteric femoral fractures using the proximal femoral locking plate versus the dynamic hip screw ( DHS ) .
METHODS	15 men and 5 women aged 32 to 78 ( mean , 55 ) years were randomised to the proximal femoral locking plate group , whereas 14 men and 6 women aged 38 to 75 ( mean , 59 ) years were randomised to the conventional 135-degree DHS group .
METHODS	The time to union , medialisation of the shaft , neck-shaft angle , limb shortening , varus collapse , and functional outcome ( using the Hospital for Special Surgery Hip Rating System ) were assessed .
RESULTS	Respectively in the locking plate and DHS groups , the mean times to union were 14.6 and 16.5 weeks ( p = 0.067 ) and the mean limb shortenings were 0.3 and 1.4 cm ( p < 0.001 ) .
RESULTS	Medialisation of the shaft occurred in 0 and 15 patients ( p < 0.0001 ) ; varus collapse occurred in 2 and 5 patients ( p = 0.408 ) ; the functional hip score was good-to-excellent in 18 and 11 patients ( p = 0.031 ) ; deep wound infection occurred in 3 and 2 patients ; and implant cut-out occurred in one patient each group .
CONCLUSIONS	A non-collapsing locking plate achieved bone union in unstable intertrochanteric fractures with lower risks of limb shortening and medialisation of the shaft .

###25189113
BACKGROUND	The 360 fusion of lumbar segments is a common and well-researched therapy to treat various diseases of the spine .
BACKGROUND	But it changes the biomechanics of the spine and may cause adjacent segment disease ( ASD ) .
BACKGROUND	Among the many techniques developed to avoid this complication , one appears promising .
BACKGROUND	It combines a rigid fusion with a flexible pedicle screw system ( hybrid instrumentation , `` topping off '' ) .
BACKGROUND	However , its clinical significance is still uncertain due to the lack of conclusive data .
METHODS	The study is a randomized , therapy-controlled , two-centre trial conducted in a clinical setting at two university hospitals .
METHODS	If they meet the criteria , outpatients presenting with degenerative disc disease , facet joint arthrosis or spondylolisthesis will be included in the study and randomized into two groups : a control group undergoing conventional fusion surgery ( PLIF - posterior lumbar intervertebral fusion ) , and an intervention group undergoing fusion surgery using a new flexible pedicle screw system ( PLIF + `` topping off '' ) , which was brought on the market in 2013 .
METHODS	Follow-up examination will take place immediately after surgery , after 6 weeks and after 6 , 12 , 24 and 36 months .
METHODS	An ongoing assessment will be performed every year.Outcome measurements will include quality of life and pain assessments using validated questionnaires ( ODI - Ostwestry Disability Index , SF-36 - Short Form Health Survey 36 , COMI - Core Outcome Measure Index ) .
METHODS	In addition , clinical and radiologic ASD , sagittal balance parameters and duration of work disability will be assessed .
METHODS	Inpatient and 6-month mortality , surgery-related data ( e.g. , intraoperative complications , blood loss , length of incision , surgical duration ) , postoperative complications ( e.g. implant failure ) , adverse events , and serious adverse events will be monitored and documented throughout the study .
CONCLUSIONS	New hybrid `` topping off '' systems might improve the outcome of lumbar spine fusion .
CONCLUSIONS	But to date , there is a serious lack of and a great need of convincing data on safety or efficacy , including benefits and harms to the patients , of these systems .
CONCLUSIONS	Health care providers are particularly interested in such data as these implants are much more expensive than conventional implants .
CONCLUSIONS	In such a case , randomized clinical trials are the best way to evaluate benefits and risks .
BACKGROUND	NCT01852526 .

###24509551
BACKGROUND	There is insufficient evidence of a relationship between acupuncture needle sensations ( de qi ) and hypoalgesia .
BACKGROUND	The aim of this study was to investigate the effects of bidirectional needle rotation at LI10 on acupuncture needle sensations and heat pain thresholds .
METHODS	Twenty-two healthy participants received one acupuncture needle at LI10 with bidirectional rotation of the needle in one experimental session and one acupuncture needle at LI10 with mock rotation in a separate session , in a randomised order .
METHODS	Measurements of heat pain thresholds were taken before needle insertion , during needle retention and 15min after needle removal .
METHODS	At each measurement time point , participants rated needle sensations using the Massachusetts Acupuncture Sensation Scale ( MASS ) and a visual analogue scale ( VAS ) of overall intensity of needle sensation .
RESULTS	Bidirectional needle rotation produced significantly higher scores for VAS , MASStotal , MASSpain and MASSsensation compared with mock rotation ( all p < 0.001 ) .
RESULTS	There were significantly higher pain thresholds relative to pre-intervention baseline during ( p = 0.014 ) and after ( p < 0.001 ) bidirectional needle rotation but not during ( p = 0.1 ) or after ( p = 0.62 ) mock bidirectional needle rotation .
RESULTS	Bidirectional needle rotation increased the pain threshold relative to baseline 15min after the needles were removed ( p = 0.009 ) .
RESULTS	A significant but low correlation between needle sensation and change in pain threshold after needling was only found when data from mock and rotation interventions were combined .
CONCLUSIONS	Needle rotation increases the magnitude of hypoalgesia .
CONCLUSIONS	There is tentative evidence that needle sensation may be associated with the amount of change in pain threshold .

###24326079
OBJECTIVE	This study investigated the relationship of gratitude to wisdom .
OBJECTIVE	Both constructs are conceptually related to self-reflectivity , but they differ in their emphasis on extrapersonal resources .
OBJECTIVE	Previous wisdom research has focused mainly on intrapersonal capacities .
METHODS	In Study 1 , 47 wisdom nominees and 47 control participants were interviewed about their most difficult and best life event and filled out a questionnaire on sources of gratitude .
METHODS	Study 2 was a quantitative study ( N = 443 ) of the relationship between a wisdom scale and scale measures and individual sources of gratitude .
RESULTS	Significantly more wisdom nominees expressed feelings of gratitude spontaneously in their interview .
RESULTS	Wisdom nominees reported gratitude for their life in general , religion , and partner more often than control participants .
RESULTS	In Study 2 , wisdom was related to all gratitude scales and to similar sources of gratitude as in Study 1 .
RESULTS	Both studies found gender differences in gratitude but not wisdom .
CONCLUSIONS	Two important implications of these findings are that wisdom entails an appreciation of life and its experiences , especially the growth opportunities that may result from negative events , and that there may be substantial differences between male and female pathways to wisdom .

###25494657
OBJECTIVE	To investigate the impact of including fluorine-18 fludeoxyglucose ( ( 18 ) F-FDG ) positron emission tomography ( PET ) scanning in the planning of paediatric radiotherapy ( RT ) .
METHODS	Target volumes were first delineated without and subsequently re-delineated with access to ( 18 ) F-FDG PET scan information , on duplicate CT sets .
METHODS	RT plans were generated for three-dimensional conformal photon RT ( 3DCRT ) and intensity-modulated proton therapy ( IMPT ) .
METHODS	The results were evaluated by comparison of target volumes , target dose coverage parameters , normal tissue complication probability ( NTCP ) and estimated risk of secondary cancer ( SC ) .
RESULTS	Considerable deviations between CT - and PET/CT-guided target volumes were seen in 3 out of the 11 patients studied .
RESULTS	However , averaging over the whole cohort , CT or PET/CT guidance introduced no significant difference in the shape or size of the target volumes , target dose coverage , irradiated volumes , estimated NTCP or SC risk , neither for IMPT nor 3DCRT .
CONCLUSIONS	Our results imply that the inclusion of PET/CT scans in the RT planning process could have considerable impact for individual patients .
CONCLUSIONS	There were no general trends of increasing or decreasing irradiated volumes , suggesting that the long-term morbidity of RT in childhood would on average remain largely unaffected .
CONCLUSIONS	( 18 ) F-FDG PET-based RT planning does not systematically change NTCP or SC risk for paediatric cancer patients compared with CT only .
CONCLUSIONS	3 out of 11 patients had a distinct change of target volumes when PET-guided planning was introduced .
CONCLUSIONS	Dice and mismatch metrics are not sufficient to assess the consequences of target volume differences in the context of RT. .

###24384429
BACKGROUND	High success rate of intubation and short intubation time have been needed to endoscopists for a complete and comfortable colonoscopy , if possible .
BACKGROUND	The purpose of present study was to compare procedure efficiencies according to adult-colonoscope length .
METHODS	This was a prospective , randomized , single-blinded controlled trial .
METHODS	A total of 239 healthy Korean subjects were randomly assigned to two groups : one group receiving intermediate-length adult-colonoscope ( n = 119 ) , and the other group receiving long-length adult-colonoscope ( n = 120 ) .
METHODS	Cecal intubation time and rate , and terminal ileal intubation time and rate as well as other procedure-related outcomes ( adenoma detection rate , withdrawal time , and total procedure time ) were evaluated .
RESULTS	There were significant differences in cecal intubation time and terminal ileal intubation rate according to colonoscope length .
RESULTS	The time of cecal intubation was shorter in the intermediate-scope group than that in the long-scope group ( ( 222.13 101.67 ) s vs. ( 253.85 109.40 ) s , P = 0.014 ) .
RESULTS	However , the rate of terminal ileal intubation was higher in the long-scope group than that in the intermediate-scope group ( 94.2 % vs. 83.2 % , P = 0.007 ) .
RESULTS	In addition , terminal ileal intubation time was also shorter in the long-scope group than that in the intermediate-scope group ( ( 35.21 38.89 ) s vs. ( 44.09 33.87 ) s , P < 0.001 ) .
RESULTS	There were no significant differences in other procedure-related outcomes between the two groups .
CONCLUSIONS	The intermediate-length adult-colonoscope had an advantage over the long-length adult-colonoscope regarding cecal intubation time , whereas the long-scope had an advantage over the intermediate-scope regarding the rate and time of terminal ileal intubation .
CONCLUSIONS	These results suggest that it is rational to prepare and use these two types of colonoscope properly , instead of employing only one type of colonoscope .

###25533774
BACKGROUND	No medical treatment has been reliably shown to halt or reverse disease progression in hypertrophic cardiomyopathy , but the results of several pilot studies have suggested beneficial effects of angiotensin II receptor blockers on left ventricular hypertrophy and fibrosis , which are predictive of an adverse outcome .
BACKGROUND	We aimed to assess the effect of the angiotensin II receptor blocker losartan on left ventricular hypertrophy and fibrosis in patients with hypertrophic cardiomyopathy .
METHODS	In this single-centre , randomised , double-blind , placebo-controlled trial , adult patients ( aged 18 years and older ) with obstructive or non-obstructive hypertrophic cardiomyopathy were randomly assigned via computer-based system to losartan ( 100 mg per day ) or placebo for 12 months .
METHODS	Patients and investigators were masked to assigned treatment .
METHODS	The primary endpoint was change in left ventricular mass as assessed by cardiac magnetic resonance imaging ( CMR ) or CT. .
METHODS	Efficacy analyses were done in the modified intention-to-treat population ( all patients with data available at the 12-month follow-up ) .
METHODS	The trial is registered with ClinicalTrials.gov , number NCT01447654 .
RESULTS	Between Dec 1 , 2011 , and May 1 , 2013 , 318 patients were screened .
RESULTS	133 patients ( mean age 52 years [ SD 13 ] , 35 % women ) consented and were randomly assigned to placebo ( n = 69 ) or losartan ( n = 64 ) .
RESULTS	124 ( 93 % ) patients completed the study and were included in the modified intention-to-treat analysis for the primary endpoint .
RESULTS	After 12 months we noted no significant difference in the change in left ventricular mass between the placebo group and the losartan group ( mean difference 1 g/m ( 2 ) , 95 % CI -3 to 6 ; p = 060 ) .
RESULTS	A decrease in systolic blood pressure in the losartan group ( from mean 127 mm Hg [ SD 12 ] to 121 mm Hg [ 14 ] ; p = 00001 ) confirmed drug compliance ; blood pressure did not decrease in the placebo group .
RESULTS	Two ( 2 % ) patients , both in the placebo group , died from sudden cardiac death during follow-up .
RESULTS	In the losartan group , one ( 1 % ) patient had angioedema , one ( 1 % ) had deterioration of renal function , and one ( 1 % ) had hyperkalaemia .
RESULTS	Treatment was well tolerated by patients with left ventricular outflow obstruction at baseline .
CONCLUSIONS	Our findings challenge the generally held view that angiotensin II receptor blockers reduce cardiac hypertrophy .
CONCLUSIONS	Treatment with losartan was safe , suggesting that it can be used for other indications in patients with hypertrophic cardiomyopathy , irrespective of obstructive physiology .
CONCLUSIONS	Additional studies are needed to assess the effect of angiotensin II receptor blockers in preclinical hypertrophic cardiomyopathy-eg , in genotype-positive but phenotype-negative individuals .

###24843973
OBJECTIVE	To evaluate electroacupuncture on the efficacy and the safety of gastric and systemic functional recovery in patients with carbon dioxide pneumoperitoneum undergoing gynaecological laparoscopic surgery .
METHODS	Sixty patients undergoing gynaecological laparoscopic surgery were randomly divided into a regular anesthesia group ( group A ) and a combination electroacupuncture anesthesia group ( group B ) , 30 cases in each group .
METHODS	The group A were treated with regular general anesthesia , and on the basis of general anesthesia , the group B were treated with electroacupuncture at bilateral Zusanli ( ST 36 ) and Liangqiu ( ST 34 ) by continuous wave and a frequency of 2 Hz 30 minutes before the surgery until the end of the operation .
METHODS	Sedation scale by Ramsay , nausea , vomiting and mental state scores of postoperative were evaluated and compared between the two groups .
RESULTS	Compared with the group A , the sedation scale ( 1.19 + / - 0.56 vs 1.96 + / - 0.90 ) , nausea score ( 0.59 + / - 0.80 vs 1.81 + / - 0.88 ) , vomiting score ( 0.48 + / - 0.94 vs 1.89 + / - 0.93 ) and mental state score ( 0.96 + / - 0.73 vs 1.69 + / - 0.75 ) were all decreased significantly in the group B ( all P < 0.01 ) .
CONCLUSIONS	Combination electroacupuncture anesthesia can relieve postoperative irritable , nausea and vomiting , improve mental state after the operation and promote the gastric and systemic functional recovery .
CONCLUSIONS	It is a good method for the adjustment of carbon dioxide pneumoperitoneum during laparoscopic surgery .

###24704135
OBJECTIVE	To examine whether an efficacious voucher-based incentives intervention for decreasing smoking during pregnancy and increasing fetal growth could be improved without increasing costs .
OBJECTIVE	The strategy was to redistribute the usual incentives so that higher values were available early in the quit attempt .
METHODS	118 pregnant smokers in greater Burlington , Vermont ( studied December , 2006-June , 2012 ) were randomly assigned to the revised contingent voucher ( RCV ) or usual contingent voucher ( CV ) schedule of abstinence-contingent vouchers , or to a non-contingent voucher ( NCV ) control condition wherein vouchers were provided independent of smoking status .
METHODS	Smoking status was biochemically verified ; serial sonographic estimates of fetal growth were obtained at gestational weeks 30-34 .
RESULTS	RCV and CV conditions increased point-prevalence abstinence above NCV levels at early ( RCV : 40 % , CV : 46 % , NCV : 13 % , p = .007 ) and late-pregnancy ( RCV : 45 % ; CV : 36 % ; NCV , 18 % ; p = .04 ) assessments , but abstinence levels did not differ between the RCV and CV conditions .
RESULTS	The RCV intervention did not increase fetal growth above control levels while the CV condition did so ( p < .05 ) .
CONCLUSIONS	This trial further supports the efficacy of CV for increasing antepartum abstinence and fetal growth , but other strategies ( e.g. , increasing overall incentive values ) will be necessary to improve outcomes further .

###25278226
BACKGROUND	The surgical resection of lung disrupts glucose homeostasis and causes hyperglycemia , as in any other major surgery or critical illness .
BACKGROUND	We performed a prospective study where we carefully lowered hyperglycemia by insulin administration during the surgery , and for the first time we monitored immediate insulin effects on lung physiology and gene transcription .
METHODS	The levels of blood gases ( pH , pCO2 , pO2 , HCO3 - , HCO3 - std , base excess , FiO2 , and pO2/FiO2 ) were measured at the beginning of surgery , at the end of surgery , and two hours after .
METHODS	Samples of healthy lung tissue surrounding the tumour were obtained during the surgery , anonymized and sent for subsequent blinded qPCR analysis ( mRNA levels of surfactant proteins A1 , A2 , B , C and D were measured ) .
METHODS	This study was done on a cohort of 64 patients who underwent lung resection .
METHODS	Patients were randomly divided , and half of them received insulin treatment during the surgery .
RESULTS	We demonstrated for the first time that insulin administered intravenously during lung resection does not affect levels of blood gases .
RESULTS	Furthermore , it does not induce immediate changes in the expression of surfactant proteins .
CONCLUSIONS	According to our observations , short insulin treatment applied intravenously during resection does not affect the quality of breathing .

###25714213
OBJECTIVE	Postoperative atrial fibrillation is a common complication after cardiac surgery , with an incidence as high as 20-50 % .
OBJECTIVE	Increased age is associated with a significant increase in postoperative atrial fibrillation risk .
OBJECTIVE	This common complication is associated with higher morbidity and mortality rates .
OBJECTIVE	The aim of this study was to assess the efficacy of nebivolol in preventing atrial fibrillation following coronary artery bypass surgery in patients over 60 years of age .
METHODS	In this prospective randomized study , 200 patients who were candidates for elective coronary artery bypass surgery were divided into two groups .
METHODS	The first group was administered with nebivolol and the second group was administered with metoprolol .
METHODS	Treatment was initiated four days prior to surgery , and patients were monitored for atrial fibrillation until discharge .
METHODS	Forty-one patients received 50 mg metoprolol succinate daily , which was initiated minimum 4 days before surgery .
RESULTS	Demographic data were similar in both groups .
RESULTS	The incidence of postoperative atrial fibrillation in both groups was similar , with no significant difference being identified [ n = 20 ( 20 % ) ; n = 18 ( 18 % ) , P = 0.718 ; respectively ] .
RESULTS	There were not any mortality at both groups during study .
RESULTS	Inotropic agent requirement at ICU was similar for both groups [ n = 12 ( 12 % ) , n = 18 ( 18 % ) , P = 0.32 ] .
CONCLUSIONS	We compared the effectiveness of nebivolol and metoprolol in decreasing the incidence of postoperative atrial fibrillation , and determined that nebivolol was as effective as metoprolol in preventing postoperative atrial fibrillation at patients .
CONCLUSIONS	Nebivolol may be the drug of choice due to its effects , especially after elective coronary artery bypass surgery .

###24912568
BACKGROUND	As a part of nationwide healthcare reforms , the Chinese government launched web-based appointment systems ( WAS ) to provide a solution to problems around outpatient appointments and services .
BACKGROUND	These have been in place in all Chinese public tertiary hospitals since 2009 .
METHODS	Questionnaires were collected from both patients and doctors in one large tertiary public hospital in Shanghai , China.Data were analyzed to measure their satisfaction and views about the WAS .
RESULTS	The 1000 outpatients randomly selected for the survey were least satisfied about the waiting time to see a doctor .
RESULTS	Even though the WAS provided a much more convenient booking method , only 17 % of patients used it .
RESULTS	Of the 197 doctors surveyed , over 90 % thought it was necessary to provide alternative forms of appointment booking systems for outpatients .
RESULTS	However , about 80 % of those doctors who were not associated professors would like to provide an ` on-the-spot ' appointment option , which would lead to longer waits for patients .
CONCLUSIONS	Patients were least satisfied about the waiting times .
CONCLUSIONS	To effectively reduce appointment-waiting times is therefore an urgent issue .
CONCLUSIONS	Despite the benefits of using the WAS , most patients still registered via the usual method of queuing , suggesting that hospitals and health service providers should promote and encourage the use of the WAS .
CONCLUSIONS	Furthermore , Chinese health providers need to help doctors to take others ' opinions or feedback into consideration when treating patients to minimize the gap between patients ' and doctors ' opinions .
CONCLUSIONS	These findings may provide useful information for both practitioners and regulators , and improve recognition of this efficient and useful booking system , which may have far-reaching and positive implications for China 's ongoing reforms .

###24798080
OBJECTIVE	To examine the prediction of gestational diabetes in obese women using routine clinical measures and measurement of biomarkers related to insulin resistance in the early second trimester .
METHODS	A total of 117 obese pregnant women participating in a pilot trial of a complex intervention of dietary advice and physical activity were studied .
METHODS	Blood samples were obtained at recruitment ( 15-17 weeks ' gestation ) and demographic , clinical history and anthropometric measures recorded .
METHODS	The biomarkers analysed were plasma lipids ( HDL cholesterol , LDL cholesterol , triglycerides ) , high-sensitivity C-reactive protein , alanine transaminase , aspartate transaminase , ferritin , fructosamine , insulin , adiponectin , tissue plasminogen activator , interleukin-6 , visfatin and leptin .
METHODS	Univariate and logistic regression analyses were performed to determine independent predictors and area under the receiver-operating curve was calculated for the model .
RESULTS	Of the 106 participants included in the analysis , 29 ( 27.4 % ) developed gestational diabetes .
RESULTS	Participants with gestational diabetes were older ( P = 0.002 ) , more often of parity 2 , had higher systolic ( P = 0.02 ) and diastolic blood pressure ( P = 0.02 ) and were more likely to be black ( P = 0.009 ) .
RESULTS	Amongst the blood biomarkers measured , plasma adiponectin alone remained independently associated with gestational diabetes in adjusted models ( P = 0.002 ) .
RESULTS	The area under the receiver-operating curve for clinical factors alone ( 0.760 ) increased significantly ( area under the curve 0.834 , chi-square statistic ( 1 ) = 4.00 , P = 0.046 ) with the addition of adiponectin .
CONCLUSIONS	A combination of routinely measured clinical factors and adiponectin measured in the early second trimester in obese women may provide a useful approach to the prediction of gestational diabetes .
CONCLUSIONS	Validation in a large prospective study is required to determine the usefulness of this algorithm in clinical practice .

###24909636
BACKGROUND	Cyclooxygenase-2 ( COX-2 ) is expressed in all female reproductive organs .
BACKGROUND	Therefore , inhibitors of COX-2 may affect reproductive function .
BACKGROUND	We evaluated the effect of extended administration of meloxicam on ovulation and the menstrual cycle .
BACKGROUND	Our hypothesis was that meloxicam administered from menstrual cycle day 5 - 22 could interfere with follicular rupture , without disrupting the menstrual cycle , and could be a potential non-hormonal contraceptive method .
METHODS	The study was conducted in 56 healthy sterilized women .
METHODS	Before the onset of treatment and after the end of treatment , participants were observed during a control cycle to ensure that they had progesterone ( P ) serum levels ( > 12 nmol/l ) consistent with ovulation .
METHODS	Participants were treated for 18 days , during three consecutive cycles .
METHODS	They were randomized to 15 or 30 mg/day .
METHODS	The menstrual cycle was monitored with serial ultrasound and hormone assays in blood .
RESULTS	Fifty-six volunteers completed the study .
RESULTS	In 55 % of cycles treated with 15 mg/day and in 78 % of cycles treated with 30 mg/day ( p < 0.001 ) we observed dysfunctional ovulation defined as follicular rupture not preceded 24-48 h earlier by an LH peak or preceded by a blunted LH peak ( < 21 IU/l ) or not followed by an elevated serum P level > 12 nmol/l .
RESULTS	Ovulation was observed in 44.6 % and in 21.7 % of women in the lower dose group and the higher dose group , respectively .
RESULTS	There were no differences between the two doses in other parameters measured .
RESULTS	There were no serious adverse events and adverse events were not different between doses or between control and treated cycles .
CONCLUSIONS	Although administration of meloxicam on menstrual cycle days 5 - 22 resulted in a dose-dependent inhibition of ovulation , more than 20 % of subjects had normal ovulation with the highest dose .
CONCLUSIONS	Previous studies have shown that oral meloxicam can delay follicle rupture .
CONCLUSIONS	This study investigated daily oral meloxicam as a non-hormonal contraceptive .
CONCLUSIONS	Since ovulation occurs in over 20 % of cycles even with a high dose of 30 mg daily , it is not likely that the approach would be a highly effective contraceptive strategy .

###25512817
OBJECTIVE	Urodynamic studies are commonly performed as part of the preoperative work-up of patients undergoing surgery for stress urinary incontinence ( SUI ) .
OBJECTIVE	We aimed to assess the extent to which these urodynamic parameters influence patient selection and postoperative outcomes .
METHODS	Patients presenting with SUI were randomly assigned to two groups : one undergoing office evaluation only and the other with a preoperative urodynamic work-up .
METHODS	Patients with unfavorable urodynamic parameters ( detrusor overactivity [ DO ] and/or Valsalva leak point pressure [ VLPP ] < 60 cm H2O and/or maximum urethral closure pressure [ MUCP ] < 20 cm H2O ) were excluded from the urodynamic testing group .
METHODS	All patients in both groups underwent the transobturator midurethral sling procedure .
METHODS	Evaluation for treatment success ( reductions in urogenital distress inventory and incontinence impact questionnaire scoring along with absent positive stress test ) was done at 6 months and 1 year postoperatively .
RESULTS	A total of 72 patients were evaluated .
RESULTS	After 12 patients with any one or more of the abnormal urodynamic parameters were excluded , 30 patients were finally recruited in each of the `` urodynamic testing '' and `` office evaluation only '' groups .
RESULTS	At both the 6 - and the 12-month follow-ups , treatment outcomes ( reduction in scores and positive provocative stress test ) were significantly better in the urodynamic testing group than in the office evaluation only group ( p-values significant for all outcomes ) .
CONCLUSIONS	Our findings showed statistically significantly better treatment outcomes in the urodynamic group ( after excluding those with poor prognostic indicators such as DO , low VLPP , and MUCP ) than in the office evaluation only group .
CONCLUSIONS	We recommend exploiting the prognostic value of these urodynamic parameters for patient counseling and treatment decisions .

###24885915
BACKGROUND	Total hip replacement ( THR ) is a common elective surgical procedure and can be effective for reducing chronic pain .
BACKGROUND	However , waiting times can be considerable .
BACKGROUND	A pain self-management intervention may provide patients with skills to more effectively manage their pain and its impact during their wait for surgery .
BACKGROUND	This study aimed to evaluate the feasibility of conducting a randomized controlled trial to assess the effectiveness and cost-effectiveness of a group-based pain self-management course for patients undergoing THR .
METHODS	Patients listed for a THR at one orthopedic center were posted a study invitation pack .
METHODS	Participants were randomized to attend a pain self-management course plus standard care or standard care only .
METHODS	The lay-led course was delivered by Arthritis Care and consisted of two half-day sessions prior to surgery and one full-day session after surgery .
METHODS	Participants provided outcome and resource-use data using a diary and postal questionnaires prior to surgery and one month , three months and six months after surgery .
METHODS	Brief telephone interviews were conducted with non-participants to explore barriers to participation .
RESULTS	Invitations were sent to 385 eligible patients and 88 patients ( 23 % ) consented to participate .
RESULTS	Interviews with 57 non-participants revealed the most common reasons for non-participation were views about the course and transport difficulties .
RESULTS	Of the 43 patients randomized to the intervention group , 28 attended the pre-operative pain self-management sessions and 11 attended the post-operative sessions .
RESULTS	Participant satisfaction with the course was high , and feedback highlighted that patients enjoyed the group format .
RESULTS	Retention of participants was acceptable ( 83 % of recruited patients completed follow-up ) and questionnaire return rates were high ( 72 % to 93 % ) , with the exception of the pre-operative resource-use diary ( 35 % return rate ) .
RESULTS	Resource-use completion rates allowed for an economic evaluation from the health and social care payer perspective .
CONCLUSIONS	This study highlights the importance of feasibility work prior to a randomized controlled trial to assess recruitment methods and rates , barriers to participation , logistics of scheduling group-based interventions , acceptability of the intervention and piloting resource use questionnaires to improve data available for economic evaluations .
CONCLUSIONS	This information is of value to researchers and funders in the design and commissioning of future research .
BACKGROUND	Current Controlled Trials ISRCTN52305381 .

###24704893
OBJECTIVE	Evaluate curricular changes related to health literacy and determine impact on independent-living senior residents as part of an introductory pharmacy practice experience for third-year student pharmacists .
METHODS	Students were randomly assigned a resident whom they visited multiple times to conduct assessments and provide various services using three methods : Ask Me 3 Four Habits Model , and Teach-back .
METHODS	The study was conducted at independent-living apartments within a 24-mile radius from the St. Louis College of Pharmacy , St. Louis , Missouri .
METHODS	Participants ( n = 147 to 173 , across all three years ) were volunteer , elderly residents , living at a facility that collaborated with the research .
METHODS	Within one academic year , students collected medical and medication histories , conducted household safety checks , performed screening assessments , assessed adherence , and provided general recommendations to a resident .
METHODS	Outcomes included resident satisfaction , student satisfaction , and correlations between student use of health literacy tools and resident satisfaction .
RESULTS	Exit surveys indicated resident overall satisfaction with the program , increased understanding of health-related information , increased confidence in asking health care professionals questions about their health , and greater commitment to medication adherence as a result of the experience .
RESULTS	Students were highly satisfied with the program .
RESULTS	Analyses reveal some correlations between a previously determined performance level of student communication and resident satisfaction .
CONCLUSIONS	Students ' use of health literacy communication tools during encounters with independent-living senior residents can result in greater patient understanding and empowerment , which may in turn help improve medication adherence .

###25727806
OBJECTIVE	Recent research has pointed to the cardiovascular benefits of providing social support to others in times of stress ; however , little is known about what factors influence such benefits .
METHODS	In a between-groups design , we investigated the possible interaction between intimacy ( friend vs. stranger ) and support type ( active vs. passive ) in determining the cardiovascular responses of support providers .
METHODS	Eighty participants had their blood pressure and heart rate monitored while providing either active or passive social support to a friend or a stranger who completed a stress task .
RESULTS	Although there was no interaction effect , a significant main effect showed that those who provided passive support showed larger decreases relative to those in the active support condition .
RESULTS	There was no effect of intimacy .
RESULTS	Further , these effects withstood adjustment for a number of potential confounds ( e.g. sex and body mass index ) .
CONCLUSIONS	It appears that the greatest physiological benefit for social support providers may come from providing passive , rather than active support , regardless of whether the support receiver is a friend or a stranger .

###25228971
OBJECTIVE	Many authors recommend performing a second-look endoscopy ( SLE ) to reduce the frequency of delayed bleeding after endoscopic submucosal dissection ( ESD ) for gastric neoplasms , but these recommendations have been made despite a lack of reliable evidence supporting the effectiveness of SLE .
METHODS	From January 2012 to May 2013 , we investigated 441 gastric neoplasms treated by ESD to assess the risk factors for delayed bleeding .
METHODS	Delayed bleeding occurred in four of these lesions within 1 postoperation day .
METHODS	Therefore , we enrolled the patients with the remaining 437 lesions to determine the utility of SLE performed on the morning of postoperative day 2 .
METHODS	All lesions were randomly assigned to SLE ( 220 lesions ) groups or non-SLE ( 217 lesions ) groups .
RESULTS	Delayed bleeding occurred in 18 lesions ( 4.1 % ) .
RESULTS	A large tumor size ( > 20 mm ) was the only independent risk factor for delayed bleeding ( p = 0.007 ) .
RESULTS	The chance of delayed bleeding was not significantly different between the patients receiving a SLE ( eight cases ) and those patients not receiving a SLE ( six cases , p = 0.787 ) .
RESULTS	Furthermore , SLE for lesions with a large tumor size did not significantly decrease delayed bleeding ( p = 0.670 ) .
CONCLUSIONS	SLE had little or no influence on the prevention of delayed bleeding , irrespective of the risk factors .

###25562457
BACKGROUND	Chronic ankle instability ( CAI ) occurs in some people after a lateral ankle sprain and often results in residual feelings of instability and episodes of the ankle 's giving way .
BACKGROUND	Compared with healthy people , patients with CAI demonstrated poor postural control and used a more anteriorly and laterally positioned center of pressure ( COP ) during a single-limb static-balance task on a force plate .
BACKGROUND	Balance training is an effective means of altering traditional COP measures ; however , whether the overall location of the COP distribution under the foot also changes is unknown .
OBJECTIVE	To determine if the spatial locations of COP data points in participants with CAI change after a 4-week balance-training program .
METHODS	Randomized controlled trial .
METHODS	Laboratory .
METHODS	Thirty-one persons with self-reported CAI .
METHODS	Participants were randomly assigned to a 4-week balance-training program or no balance training .
METHODS	We collected a total of 500 COP data points while participants balanced using a single limb on a force plate during a 10-second trial .
METHODS	The location of each COP data point relative to the geometric center of the foot was determined , and the frequency count in 4 sections ( anteromedial , anterolateral , posteromedial , posterolateral ) was analyzed for differences between groups .
RESULTS	Overall , COP position in the balance-training group shifted from being more anterior to less anterior in both eyes-open trials ( before trial = 319.1 165.4 , after trial = 160.5 149.5 ; P = .006 ) and eyes-closed trials ( before trial = 387.9 123.8 , after trial = 189.4 102.9 ; P < .001 ) .
RESULTS	The COP for the group that did not perform balance training remained the same in the eyes-open trials ( before trial = 214.1 193.3 , after trial = 230.0 176.3 ; P = .54 ) and eyes-closed trials ( before trial = 326.9 134.3 , after trial = 338.2 126.1 ; P = .69 ) .
CONCLUSIONS	In participants with CAI , the balance-training program shifted the COP location from anterolateral to posterolateral .
CONCLUSIONS	The program may have repaired some of the damaged sensorimotor system pathways , resulting in a more optimally functioning and less constrained system .

###24317234
OBJECTIVE	Research suggests that the addition of dexmedetomidine to local anesthetics can prolong peripheral nerve blocks ; however , clinical safety data are limited , and interscalene blocks have not been studied .
OBJECTIVE	The present study was designed to test the hypothesis that dexmedetomidine added to ropivacaine would safely enhance the duration of analgesia without adverse effects when compared with ropivacaine alone .
METHODS	We conducted a single-center , prospective , randomized , triple-blind , controlled trial of 62 patients undergoing elective shoulder surgery under general anesthesia with an interscalene block .
METHODS	Patients underwent ultrasound-guided interscalene blocks using either 12 mL of 0.5 % ropivacaine or 0.5 % ropivacaine plus 150-g dexmedetomidine .
METHODS	The primary outcomes were self-reported duration of the nerve block and safety assessment ( adverse effects and neurological sequelae ) .
METHODS	Data were analyzed in a blinded fashion .
RESULTS	The median duration of the nerve block was 18 hours ( 95 % confidence interval , 18-20 ) in the dexmedetomidine group and 14 hours ( 95 % confidence interval , 14-16 ) in the ropivacaine group ( P = 0.0001 ) .
RESULTS	Dexmedetomidine also lowered pain scores for the first 14 hours postoperatively and significantly hastened the time to sensory ( P = 0.04 ) and motor ( P = 0.002 ) block onset .
RESULTS	Dexmedetomidine lowered heart rate but blood pressures were stable .
RESULTS	Plasma levels of ropivacaine were not different between groups , and plasma dexmedetomidine levels were relatively low .
RESULTS	There were no adverse events or neurological sequelae .
CONCLUSIONS	Dexmedetomidine added to ropivacaine for interscalene blocks increased the duration of the nerve block and improved postoperative pain .
CONCLUSIONS	These additional efficacy and safety data should encourage further study of peripheral perineural dexmedetomidine in humans .

###24824415
OBJECTIVE	We hypothesized reduction of 30 days ' in-hospital morbidity , mortality , and length of stay postimplementation of the World Health Organization 's Surgical Safety Checklist ( SSC ) .
BACKGROUND	Reductions of morbidity and mortality have been reported after SSC implementation in pre - / postdesigned studies without controls .
BACKGROUND	Here , we report a randomized controlled trial of the SSC .
METHODS	A stepped wedge cluster randomized controlled trial was conducted in 2 hospitals .
METHODS	We examined effects on in-hospital complications registered by International Classification of Diseases , Tenth Revision codes , length of stay , and mortality .
METHODS	The SSC intervention was sequentially rolled out in a random order until all 5 clusters-cardiothoracic , neurosurgery , orthopedic , general , and urologic surgery had received the Checklist .
METHODS	Data were prospectively recorded in control and intervention stages during a 10-month period in 2009-2010 .
RESULTS	A total of 2212 control procedures were compared with 2263 SCC procedures .
RESULTS	The complication rates decreased from 19.9 % to 11.5 % ( P < 0.001 ) , with absolute risk reduction 8.4 ( 95 % confidence interval , 6.3-10 .5 ) from the control to the SSC stages .
RESULTS	Adjusted for possible confounding factors , the SSC effect on complications remained significant with odds ratio 1.95 ( 95 % confidence interval , 1.59-2 .40 ) .
RESULTS	Mean length of stay decreased by 0.8 days with SCC utilization ( 95 % confidence interval , 0.11-1 .43 ) .
RESULTS	In-hospital mortality decreased significantly from 1.9 % to 0.2 % in 1 of the 2 hospitals post-SSC implementation , but the overall reduction ( 1.6 % -1.0 % ) across hospitals was not significant .
CONCLUSIONS	Implementation of the WHO SSC was associated with robust reduction in morbidity and length of in-hospital stay and some reduction in mortality .

###25099962
OBJECTIVE	To analyse the muscle adaptations induced by two protocols of isometric training performed at different muscle lengths .
METHODS	Twenty-eight subjects were divided into three groups : one ( K90 ) performed isometric training of the knee extensors at long muscle lengths ( 90 of knee flexion ) for 8 weeks , and the second group ( K50 ) at short muscle lengths ( 50 ) .
METHODS	The subjects of the third group acted as controls .
METHODS	Isokinetic dynamometry was utilized to analyse the net moment-angle relationship and vastus lateralis muscle thickness at three different locations , and pennation angles and fascicle length at 50 % of thigh length were measured at rest with ultrasonography .
RESULTS	Only subjects from K90 group showed significant increases in isokinetic strength ( 23.5 % , P < 0.001 ) , while K50 group showed no increases in isokinetic strength : ( 10 % , P > 0.05 ) .
RESULTS	There was a shift in the angle of peak torque of the K90 group to longer muscle lengths ( +14.6 % , P = 0.002 ) with greater increases in isokinetic strength , while the K50 angle shifted to shorter muscle lengths ( -7.3 % , P = 0.039 ) .
RESULTS	Both training groups showed significant increases in muscle thickness , ( K90 9-14 % vs. K50 5-9 % ) but only K90 significantly increased their pennation angles ( 11.7 % , P = 0.038 ) .
RESULTS	Fascicle lengths remained unchanged .
CONCLUSIONS	Isometric training at specific knee angles led to significant shifts of peak torque in the direction of the training muscle lengths .
CONCLUSIONS	The greater strength gains and the architectural changes with training at long muscle lengths probably come from a combination of different factors , such as the different mechanical stresses placed upon the muscle-tendon complex .

###24657033
BACKGROUND	The renoprotective effect of N-acetylcystein in patients undergoing coronary artery bypass graft surgery is controversial .
METHODS	We assessed the renoprotective effect of the highest dose of N-acetylcystein sanctioned for clinical use in a prospective , double-blind , placebo-controlled study including 70 chronic kidney disease patients , stage 3 or 4 , who underwent coronary artery bypass graft surgery , on cardiopulmonary bypass ( CPB ) and off CPB , and were randomly allocated to receive either N-acetylcystein 150 mg/kg followed by 50 mg/kg for 6 hours in 0.9 % saline or only 0.9 % saline .
METHODS	Acute kidney injury was defined by the Acute Kidney Injury Network classification .
RESULTS	The incidence of kidney injury was reduced in the N-acetylcystein group ( 57.1 % versus 28.6 % , p = 0.016 ) .
RESULTS	Nonuse of N-acetylcystein ( relative risk 3.58 , 95 % confidence interval : 1.04 to 12.33 , p = 0.04 ) and cardiopulmonary bypass ( relative risk 4.55 , 95 % confidence interval : 1.28 to 16.15 , p = 0.02 ) were independent predictors of kidney injury .
RESULTS	In patients treated with CPB , N-acetylcystein reduced the incidence of kidney injury from 63 % to 46 % .
RESULTS	Oxidative stress was increased in control subjects ( p = 0.01 ) and abolished in patients receiving N-acetylcystein .
CONCLUSIONS	Maximum intravenous doses of N-acetylcystein reduce the incidence of acute kidney injury in patients with kidney disease undergoing coronary artery bypass graft surgery , abolish oxidative stress , and mitigate the negative effect of CPB on renal function .

###24563922
BACKGROUND	This randomised , double blind prospective study compares intrathecal lidocaine with chloroprocaine in day-case surgery and the influence of a 500 ml pre-load intravenously .
BACKGROUND	We tested the hypothesis that chloroprocaine provides faster recovery and discharge in day-case surgery .
BACKGROUND	Secondary we studied the influence of a preload compared with fluid restriction on discharge time and micturition problems .
METHODS	One hundred patients undergoing day-case arthroscopy were randomised to receive either lidocaine ( L ) 60 mg or chloroprocaine ( CP ) 40 mg intrathecally and this with ( L + , CP + ) or without ( L , CP ) a 500 ml pre-load of crystalloid .
METHODS	Block characteristics , micturition and discharge times were registered .
METHODS	Bladder volumes were monitored by ultrasound .
METHODS	Micturition problems received a micturition score .
RESULTS	Onset and quality of the block were comparable between groups .
RESULTS	Time to regain Bromage 1 and L2 regression were shorter for the CP group compared with the L group .
RESULTS	Voiding ( 168 44 min ) and discharge ( 178 52 min ) were approximately 40 min faster for the CP group compared with the L group .
RESULTS	Pre-load provided faster bladder filling but there were no differences in voiding time within the CP or L group .
RESULTS	The CP + group ( 166 36 min ) was discharged faster than both L groups ( 226 57 min , 227 59 min ) .
RESULTS	More serious micturition problems occurred in the L + group compared with both CP groups .
CONCLUSIONS	Chloroprocaine is suitable for day-case surgery because of faster block regression and discharge than lidocaine .
CONCLUSIONS	A 500 ml pre-load may not affect discharge but did not increase micturition problems for chloroprocaine .

###24304990
OBJECTIVE	To compare the efficacy of metformin with insulin in the management of pregnancy with diabetes .
METHODS	Randomized clinical trial .
METHODS	Department of Obstetrics and Gynaecology , Maternal and Child Health Centre ( MCH ) , Pakistan Institute of Medical Sciences , Islamabad , from May 2010 to January 2011 .
METHODS	A total of 68 pregnant patients with diabetes were included in this study .
METHODS	Patients were randomly divided in to two groups of each 34 patients based on table of random numbers .
METHODS	One was labelled as group-A and other was labelled as group-B .
METHODS	Group-A received insulin and group-B received metformin for the management of diabetes .
RESULTS	The mean age was 29.82 4.58 and 29.35 4.97 years in groups-A and B respectively .
RESULTS	Fasting blood sugar level after 1 month was controlled in 22 ( 64.7 % ) patients in group-A and in 27 ( 79.4 % ) in group-B ( p > 0.05 ) .
RESULTS	Fasting blood sugar level at term , remained controlled in 30 ( 88.2 % ) patients in group-A and 27 ( 79.4 % ) in group-B ( p > 0.05 ) .
RESULTS	Comparison of random blood sugar levels within normal limits after 1 month in 25 ( 73.5 % ) in group-A and in 24 ( 70.6 % ) in group-B .
RESULTS	At term , random blood sugar level was controlled in 28 ( 82.4 % ) and 27 ( 79.4 % ) patients in group-A and B , respectively .
RESULTS	Comparison of post-treatment HBA1C level depicts that diabetes controlled in 27 ( 79.4 % ) patients in group-A while in 28 ( 82.3 % ) patients of group-B .
RESULTS	The efficacy of metformin and insulin in controlling diabetes was equal in two groups .
CONCLUSIONS	There was no marked difference in efficacy of metformin and insulin in controlling diabetes in pregnant patients in two groups .

###24641778
BACKGROUND	Depression is estimated to become the leading cause of disease burden globally by 2030 .
BACKGROUND	Despite existing efficacious treatments ( both medical and psychotherapeutic ) , a large proportion of patients do not respond to therapy .
BACKGROUND	Recent insights from evolutionary psychology suggest that , in addition to targeting the proximal causes of depression ( for example , targeting dysfunctional beliefs by cognitive behavioral therapy ) , the distal or evolutionary causes ( for example , inclusive fitness ) should also be addressed .
BACKGROUND	A randomized superiority trial is conducted to develop and test an evolutionary-driven cognitive therapy protocol for depression , and to compare its efficacy against standard cognitive therapy for depression .
METHODS	Romanian-speaking adults ( 18 years or older ) with elevated Beck Depression Inventory ( BDI ) scores ( > 13 ) , current diagnosis of major depressive disorder or major depressive episode ( MDD or MDE ) , and MDD with comorbid dysthymia , as evaluated by the Structured Clinical Interview for DSM-IV ( SCID ) , are included in the study .
METHODS	Participants are randomized to one of two conditions : 1 ) evolutionary-driven cognitive therapy ( ED-CT ) or 2 ) cognitive therapy ( CT ) .
METHODS	Both groups undergo 12 psychotherapy sessions , and data are collected at baseline , mid-treatment , post-treatment , and the 3-month follow-up .
METHODS	Primary outcomes are depressive symptomatology and a categorical diagnosis of depression post-treatment .
CONCLUSIONS	This randomized trial compares the newly proposed ED-CT with a classic CT protocol for depression .
CONCLUSIONS	To our knowledge , this is the first attempt to integrate insights from evolutionary theories of depression into the treatment of this condition in a controlled manner .
CONCLUSIONS	This study can thus add substantially to the body of knowledge on validated treatments for depression .
BACKGROUND	Current Controlled Trials ISRCTN64664414The trial was registered in June 2013 .
BACKGROUND	The first participant was enrolled on October 3 , 2012 .

###24266497
OBJECTIVE	This study aimed to examine healthcare provider ( HCP ) recommendations and patient preferences for the insulin pen versus vial-and-syringe in patients with type 2 diabetes mellitus ( T2DM ) and to assess clinical end points and safety outcomes .
METHODS	Using a randomized , open-label , crossover design , in total , 405 insulin-naive adults with T2DM from 60 centers received basal insulin glargine in one of two device treatment sequences ( 2 weeks of pen followed by 2 weeks of vial-and-syringe , or vice versa ) .
METHODS	The primary end point , patient device preference , was evaluated at Week 4 ( end of the crossover period ) using the Insulin Injection Preference Questionnaire .
METHODS	Patient preference and HCP recommendation were assessed with one global item and three subscale items ( blood glucose control , reluctance to use insulin , and long-term insulin use ) using a 5-point scale ranging from 1 = not preferred or not recommended to 5 = preferred or recommended .
METHODS	Patients were then re-randomized to either pen or vial-and-syringe for further observation ( 6 , 10 , and 30 weeks ) to evaluate clinical end points ( glycosylated hemoglobin [ A1C ] and fasting blood glucose levels ) and safety outcomes ( hypoglycemia and adverse events ) .
RESULTS	Patients reported a significant preference for pens over vial-and-syringe , and HCPs strongly recommended pens over vial-and-syringe ( both P < 0.001 ) .
RESULTS	Consistent response patterns were observed by HCPs and patients for the three subscale items .
RESULTS	Fasting blood glucose , A1C levels , and the incidence of hypoglycemia were comparable in the two groups .
CONCLUSIONS	Patients preferred pens over vial-and-syringe , with the pen device also recommended by HCPs , when initiating basal insulin treatment in insulin-naive patients with T2DM .

###25176944
OBJECTIVE	Rejection is one of the major causes of late cardiac allograft failure and at present can only be diagnosed by invasive endomyocardial biopsies .
OBJECTIVE	We sought to determine whether microRNA profiling could serve as a non-invasive biomarker of cardiac allograft rejection .
METHODS	We included 113 heart transplant recipients from four referral French institutions ( test cohort , n = 60 , validation cohort , n = 53 ) .
METHODS	In the test cohort , we compared patients with acute biopsy-proven allograft rejection ( n = 30 ) to matched control patients without rejection ( n = 30 ) , by assessing microRNAs expression in the heart allograft tissue and patients concomitant serum using RNA extraction and qPCR analysis .
METHODS	Fourteen miRNAs were selected on the basis of their implication in allograft rejection , endothelial activation , and inflammation and tissue specificity .
RESULTS	We identified seven miRNAs that were differentially expressed between normal and rejecting heart allografts : miR-10a , miR-21 , miR-31 , miR-92a , miR-142-3p miR-155 , and miR-451 ( P < 0.0001 for all comparisons ) .
RESULTS	Four out of seven miRNAs also showed differential serological expression ( miR-10a , miR-31 , miR-92a , and miR-155 ) with strong correlation with their tissular expression .
RESULTS	The receiver-operating characteristic analysis showed that these four circulating miRNAs strongly discriminated patients with allograft rejection from patients without rejection : miR-10a ( AUC = 0.975 ) , miR-31 ( AUC = 0.932 ) , miR-92a ( AUC = 0.989 ) , and miR-155 ( AUC = 0.998 , P < 0.0001 for all comparisons ) .
RESULTS	We confirmed in the external validation set that these four miRNAs highly discriminated patients with rejection from those without .
RESULTS	The discrimination capability of the four miRNAs remained significant when stratified by rejection diagnosis ( T-cell-mediated rejection or antibody-mediated rejection ) and time post-transplant .
CONCLUSIONS	This study demonstrates that a differential expression of miRNA occurs in rejecting allograft patients , not only at the tissue level but also in the serum , suggesting their potential relevance as non-invasive biomarkers in heart transplant rejection .

###24889103
BACKGROUND	There has been little robust evaluation of the outcome of speech and language therapy ( SLT ) intervention for post-stroke dysarthria .
BACKGROUND	Non-speech oro-motor exercises ( NSOMExs ) are a common component of dysarthria intervention .
BACKGROUND	A feasibility study was designed and executed , with participants randomized into two groups , in one of which NSOMExs were a component of the intervention programme .
OBJECTIVE	To examine ( 1 ) operational feasibility of the programme ; ( 2 ) participants ' views of the programme ; and ( 3 ) speech intelligibility , communication effectiveness and tongue and lip movement at four points ( A1 and A2 before , and A3 and A4 after intervention ) .
METHODS	Thirty-nine participants were randomized into Group A ( n = 20 ) and Group B ( n = 19 ) .
METHODS	Groups were equivalent at enrolment in demographic variables and A1 measures .
METHODS	Intervention was behavioural , delivered in eight home-based SLT sessions , and included practise of individually appropriate words , sentences and conversation , and for Group B also NSOMExs .
METHODS	Between-session practice was recorded in a diary .
METHODS	Data on speech intelligibility , effectiveness of communication in conversation , self-rated situational communication effectiveness , and tongue and lip movement were collected at 8-week intervals , twice before and twice after intervention .
METHODS	Anonymous evaluation ( AE ) questionnaires were completed .
RESULTS	The recruited number was 20 % below the target of 50 .
RESULTS	Thirty-six participants completed the intervention and 32 were followed through to A4 .
RESULTS	The programme was delivered to protocol and fidelity was verified .
RESULTS	Thirty-four AEs were returned .
RESULTS	These showed high satisfaction with the programme and its outcome .
RESULTS	According to diary records from 32 participants , 59 % carried out at least the recommended practice amount .
RESULTS	Outcome measure performance across the four assessment points did not indicate any group effect .
RESULTS	For the whole sample both externally rated and self-rated communication effectiveness measures showed statistically significant gains across the intervention period ( A2/A3 ) , which were maintained for 2 months after intervention ( A2/A4 ) .
RESULTS	Non-intervention period changes ( A1/A2 and A3/A4 ) were not present .
RESULTS	There were no intervention-related gains in tongue and lip movement or speech intelligibility , but the latter is likely to be attributable to a ceiling effect on scores .
CONCLUSIONS	The results indicate positive outcomes associated with a short period of behavioural SLT intervention in the post-stroke dysarthria population .
CONCLUSIONS	The inclusion of NSOMExs , delivered in accordance with standard clinical practice , did not appear to influence outcomes .
CONCLUSIONS	The results must be viewed in relation to the nature of feasibility study and provide a foundation for suitably powered trials .

###25539792
BACKGROUND	Pulmonary dysfunction complicates cardiac surgery that includes cardiopulmonary bypass .
BACKGROUND	The pulmonary protection trial evaluates effect of pulmonary perfusion on pulmonary function in patients suffering from chronic obstructive pulmonary disease .
BACKGROUND	This paper presents the statistical plan for the main publication to avoid risk of outcome reporting bias , selective reporting , and data-driven results as an update to the published design and method for the trial .
RESULTS	The pulmonary protection trial is a randomized , parallel group clinical trial that assesses the effect of pulmonary perfusion with oxygenated blood or Custodiol HTK ( histidine-tryptophan-ketoglutarate ) solution versus no pulmonary perfusion in 90 chronic obstructive pulmonary disease patients .
RESULTS	Patients , the statistician , and the conclusion drawers are blinded to intervention allocation .
RESULTS	The primary outcome is the oxygenation index from 10 to 15 minutes after the end of cardiopulmonary bypass until 24 hours thereafter .
RESULTS	Secondary outcome measures are oral tracheal intubation time , days alive outside the intensive care unit , days alive outside the hospital , and 30 - and 90-day mortality , and one or more of the following selected serious adverse events : pneumothorax or pleural effusion requiring drainage , major bleeding , reoperation , severe infection , cerebral event , hyperkaliemia , acute myocardial infarction , cardiac arrhythmia , renal replacement therapy , and readmission for a respiratory-related problem .
CONCLUSIONS	The pulmonary protection trial investigates the effect of pulmonary perfusion during cardiopulmonary bypass in chronic obstructive pulmonary disease patients .
CONCLUSIONS	A preserved oxygenation index following pulmonary perfusion may indicate an effect and inspire to a multicenter confirmatory trial to assess a more clinically relevant outcome .
BACKGROUND	ClinicalTrials.gov identifier : NCT01614951 , registered on 6 June 2012 .

###25370504
BACKGROUND	Recently , internet-based interventions have been proposed as effective treatments for people with panic disorder ( PD ) .
BACKGROUND	However , little is known about the clinical effects of integrating mobile technology into these interventions .
BACKGROUND	Because users carry their smartphones with them throughout the day , we hypothesize that this technology can be used to significantly support individuals with monitoring and overcoming their PD symptoms .
BACKGROUND	The aim of the present study is to evaluate the efficacy and cost-effectiveness of a newly developed hybrid intervention that combines internet/PC with smartphone delivery to treat the symptoms of PD .
BACKGROUND	The intervention is based on cognitive behavioral therapy and consists of six modules over a total of six weeks .
METHODS	A two-arm randomized controlled trial ( RCT ) will be conducted to evaluate the effects of a hybrid online training module for PD .
METHODS	Based on a power calculation ( d = 0.60 ; 1 - of 80 % ; = 0.05 ) , 90 participants with mild to moderate panic symptoms with or without agoraphobia ( as assessed by the Panic and Agoraphobia Scale ) will be recruited from the general population and randomly assigned to either the intervention group or a six-month waitlist control group .
METHODS	The primary outcome measure will be the severity of panic symptoms .
METHODS	Secondary outcomes will include depression , quality of life , and an observer-based rating of panic severity .
METHODS	Furthermore , data regarding acceptance and the usability of the smartphone app will be assessed .
METHODS	Assessments will take place at baseline as well as eight weeks , three months , and six months after randomization .
METHODS	Moreover , a cost-effectiveness analysis will be performed from a societal perspective .
METHODS	Data will be analyzed on an intention-to-treat basis and per protocol .
CONCLUSIONS	To our knowledge , this RCT is one of the first to examine the efficacy of a hybrid online training for adult PD .
CONCLUSIONS	This study seeks to contribute to the emerging field of hybrid online training .
CONCLUSIONS	If the intervention is efficacious , then research on this hybrid online training should be extended .
CONCLUSIONS	The cost-effectiveness analysis will also indicate whether online training is an economical tool for treating PD among adults .
BACKGROUND	German Clinical Trial Register : DRKS00005223 ( registered on 15 August 2013 ) .

###25284194
BACKGROUND	Heart disease progression occurs in 30 % of patients with chronic Trypanosoma cruzi infection .
BACKGROUND	Supplementation with selenium ( Se ) in animal model of T. cruzi infection produced promising results .
BACKGROUND	There is evidence that patients with Chagas heart disease have lower Se levels than healthy individuals and patients with T. cruzi infection without of cardiac disease .
BACKGROUND	The aim of this investigation is to estimate the effect of Se treatment on prevention of heart disease progression in patients with chagasic cardiopathy .
METHODS	The Selenium Treatment and Chagasic Cardiopathy trial is a superiority , double-blind , placebo-controlled , randomized clinical trial .
METHODS	The eligibility criteria are as follows : ( 1 ) a Chagas disease diagnosis confirmed by serology ; ( 2 ) segmental , mild or moderate global left ventricular systolic dysfunction ; and ( 3 ) age between 18 and 65 years .
METHODS	The exclusion criteria are as follows : ( 1 ) pregnancy , ( 2 ) diabetes mellitus , ( 3 ) tobacco use , ( 4 ) alcohol abuse , ( 5 ) evidence of nonchagasic heart disease , ( 6 ) depression , ( 7 ) dysphagia with evidence of food residues in the esophagus , ( 8 ) dysphagia with weight loss higher than 15 % of usual weight in the last four months and/or ( 9 ) conditions that may result in low protocol adherence .
METHODS	The intervention will be 100 g of sodium selenite once daily for 365 consecutive days compared to placebo .
METHODS	The following are the primary outcomes to be measured : ( 1 ) the trajectories of the left ventricular ejection fraction in the follow-up period ; ( 2 ) reduction of heart disease progression rates , with progression defined as a 10 % decrease in left ventricular ejection fraction ; and ( 3 ) rate of hospital admissions attributable to dysrhythmia , heart failure or stroke due to Chagas disease .
METHODS	One hundred thirty patients will be randomly allocated into either the intervention or placebo group at a ratio of 1:1 .
METHODS	The sequence allocation concealment and blinding were planned to be conducted with the strategy of numbered boxes .
METHODS	Both patients and health-care providers will remain blinded to the intervention groups during the 5 years of follow-up .
CONCLUSIONS	If Se treatment reduces the progression of Chagas cardiopathy , the inclusion of this micronutrient in the daily diet can improve the therapeutic regimen for this neglected tropical disease at low cost .
BACKGROUND	Clinical Trials.gov ID : NCT00875173 ( registered 20 October 20 2008 ) .

###25540305
OBJECTIVE	To study whether 60-Hz stimulation , compared with routine 130 Hz , improves swallowing function and freezing of gait ( FOG ) in patients with Parkinson disease ( PD ) who undergo bilateral subthalamic nucleus ( STN ) deep brain stimulation ( DBS ) .
METHODS	We studied 7 patients with PD who experienced FOG that persisted despite routine 130-Hz stimulation and dopaminergic medication .
METHODS	Each patient received 3 modified barium swallow ( MBS ) studies in a single day under 3 DBS conditions in the medication-on state : 130 Hz , 60 Hz , or DBS off , in a randomized double-blind manner .
METHODS	The laryngeal penetration and aspiration events were cautiously assessed , and a swallowing questionnaire was completed .
METHODS	The Unified Parkinson 's Disease Rating Scale , Part III motor score , axial subscore , tremor subscore , and FOG by a questionnaire and stand-walk-sit test were also assessed .
METHODS	The best DBS condition ( 60 Hz here ) producing the least FOG was maintained for 3 to 8 weeks , and patients were assessed again .
METHODS	Changes in measurements between the 60 Hz and 130 Hz were analyzed using paired t test , with swallowing function as primary and the remainder as secondary outcomes .
METHODS	Changes between other DBS conditions were further explored with Bonferroni correction .
RESULTS	Compared with the routine 130 Hz , 60-Hz stimulation significantly reduced aspiration frequency by 57 % on MBS study and perceived swallowing difficulty by 80 % on questionnaire .
RESULTS	It also significantly reduced FOG , and axial and parkinsonian symptoms .
RESULTS	The benefits at 60-Hz stimulation persisted over the average 6-week assessment .
CONCLUSIONS	Compared with the routine 130 Hz , the 60-Hz stimulation significantly improved swallowing function , FOG , and axial and parkinsonian symptoms in patients with PD treated with bilateral STN-DBS , which persisted over the 6-week study period .
METHODS	This study provides Class IV evidence that for patients with PD who experience FOG , STN-DBS at 60 Hz decreases aspiration events observed during MBS compared with DBS at 130 Hz .

###24977459
OBJECTIVE	This study aims to assess the endometrial safety of ospemifene based on phase 2/3 clinical trials of postmenopausal women with up to 52 weeks of exposure to ospemifene 60 mg/day versus placebo .
METHODS	Endometrial safety was evaluated in a development program of six randomized , double-blind , placebo-controlled , parallel-group studies of postmenopausal women aged between 40 and 80 years who had vulvar and vaginal atrophy .
METHODS	Participants were randomized 1:1 to ospemifene 60 mg/day or placebo in one 6-week trial and three 12-week trials ; one of the 12-week trials had a 40-week extension study .
METHODS	In a separate 52-week trial , women were randomized 6:1 to ospemifene 60 mg/day or placebo .
METHODS	Endometrial safety was assessed by endometrial histology ( biopsy ) , transvaginal ultrasound , and gynecologic examination .
RESULTS	In these trials , 1,242 women who received ospemifene 60 mg/day and 924 women who received placebo were evaluable for safety .
RESULTS	Endometrial hyperplasia occurred in less than 1 % of women treated with ospemifene ; no endometrial cancer was reported .
RESULTS	The mean ( SD ) increase in endometrial thickness among women treated with ospemifene was 0.51 ( 1.54 ) mm at 12 weeks , 0.56 ( 1.61 ) mm at 6 months , and 0.81 ( 1.54 ) mm at 12 months .
RESULTS	Women who received placebo had a mean ( SD ) increase of 0.07 ( 1.23 ) mm at 12 months .
CONCLUSIONS	These clinical trial data indicate that up to 52 weeks of treatment with oral ospemifene 60 mg/day was safe for the endometrium .
CONCLUSIONS	There was no increase in the incidence of endometrial cancer or hyperplasia among postmenopausal women treated with ospemifene compared with placebo .

###25209122
BACKGROUND	We conducted a prospective randomized trial to compare the most popular osteotomy types of operative treatment of hallux valgus ( HV ) used in Norway , Mitchell 's osteotomy ( MO ) and chevron osteotomy ( CO ) .
METHODS	One hundred twenty adult female patients were prospectively randomized to treatment with either MO or CO. .
METHODS	All operative procedures were performed with ankle block and with tourniquet applied .
METHODS	None of the patients received any antibiotic or antithrombotic prophylaxis .
METHODS	The follow-up period was 3 years .
METHODS	Clinical results were rated according to the American Orthopaedic Foot and Ankle Society ( AOFAS ) Clinical Rating System ( CRS ) .
RESULTS	HV in the MO group was reduced from 30 ( range , 20 to 44 ) to 15 ( range , 8 to 24 ) degrees and IM angle from 11 ( range , 6 to 14 ) to 7 ( range , 4 to 11 ) degrees .
RESULTS	HV in the CO group was reduced from 31 ( range , 22 to 42 ) to 16 ( range , 6 to 24 ) degrees and IM angle from 14 ( range , 8 to 20 ) to 6 ( range , 2 to 10 ) degrees .
RESULTS	Transfer metatarsalgia occurred in 36 ( 60 % ) patients and hammertoe in 6 ( 10 % ) patients in the MO group .
RESULTS	In the CO group , metatarsalgia occurred in 5 patients .
RESULTS	The median loss of postoperative HV correction was 4 ( range , 2 to 10 ) degrees in mild deformity and 6 ( 6 to 10 ) degrees in moderate deformity .
CONCLUSIONS	Patients treated with CO had significantly better results for AOFAS CRS , number of postoperative complications , patient satisfaction , and length of sick leave for the employed patients .
CONCLUSIONS	Based on our results , we consider that in female patients CO should be regarded as the first-line procedure for treatment of mild and moderate HV .
METHODS	Level I , prospective randomized study .

###24464788
OBJECTIVE	Comorbidities are frequent in heart failure and impact outcomes .
OBJECTIVE	It is not known whether comorbidities are associated with outcomes in asymptomatic left ventricular dysfunction compared to clinical heart failure and whether comorbidities interfere with treatment effects .
OBJECTIVE	Our objective was to assess comorbidities and their effects on outcomes in predominantly asymptomatic populations without previous heart failure treatment of the SOLVD prevention trial , compared to symptomatic heart failure patients of SOLVD treatment and to evaluate associations to the effect of enalapril .
RESULTS	This post hoc analysis from the SOLVD prevention and SOLVD treatment trials includes 4228 patients with left ventricular dysfunction and 2569 patients with heart failure .
RESULTS	The preexisting comorbidities hypertension , diabetes mellitus , pulmonary disease , angina pectoris , renal impairment , and anaemia were similar in SOLVD treatment and SOLVD prevention , with a higher prevalence in SOLVD treatment .
RESULTS	Comorbidities are significantly associated with the primary composite of SOLVD time to death or heart failure hospitalization ( SOLVD prevention : HR 4.8 , CI : 3.2-7 .18 , P < 0.0001 ; SOLVD treatment : HR 2.9 , CI : 2.12-3 .95 , P < 0.0001 for more than four comorbidities vs. no comorbidities ) , and to death , heart failure hospitalization , and cardiovascular death where the effect of the number of coexisting comorbidities was additive .
RESULTS	There was no significant interaction of comorbidities with treatment effects of enalapril .
CONCLUSIONS	Comorbidities increased events in asymptomatic left ventricular dysfunction and in symptomatic heart failure , but did not interfere with the effects of enalapril .
CONCLUSIONS	Comorbidities need to be adequately addressed in clinical trials , which should also involve non-cardiac treatments in order to improve outcome for heart failure patients .

###24962529
BACKGROUND	The goal of this study was to report the results of selective open reduction and internal fixation of fractures of the posterior malleolus with a posterolateral approach and to compare the results of the 2 techniques .
METHODS	We prospectively evaluated 40 patients who underwent posterior malleolar fracture fixation between 2008 and 2012 .
METHODS	The patients were treated with a posterolateral approach .
METHODS	We assigned alternating patients to receive plate fixation and the next screw fixation , consecutively , based on the order in which they presented to our institution .
METHODS	Fixation of the posterior malleolus was made with lag screws in 20 patients and a buttress plate in 20 patients .
METHODS	We used American Orthopaedic Foot and Ankle Society ( AOFAS ) scores , range of motion ( ROM ) of the ankle , and radiographic evaluations as the main outcome measurements .
METHODS	The mean follow-up was 38.2 ( range , 24-51 ) months .
RESULTS	Full union without any loss of reduction was obtained in 38 of the 40 patients .
RESULTS	We detected a union with a step-off of 3 mm in 1 patient in the screw group and a step-off of 2 mm in 1 patient in the plate group .
RESULTS	At the final follow-up , the mean AOFAS score of the patients regardless of fixation type was 94.1 ( range , 85-100 ) .
RESULTS	The statistical results showed no significant difference between the patients regardless of the fixation type of the posterior malleolus in terms of AOFAS scores and ROM of the ankle ( P > .05 ) .
CONCLUSIONS	Good ( AOFAS score of 94/100 ) and equivalent ( within 3 points ) results were obtained using the 2 techniques ( screws or plate ) for fixation after open reduction of posterior malleolar fragments .
METHODS	Level II , prospective case series .

###24610807
BACKGROUND	This study reports the impact of cardiac resynchronization therapy ( CRT ) on hospitalizations in patients randomized to implantable cardioverter-defibrillator ( ICD ) or ICD-CRT in the Resynchronization-Defibrillation for Ambulatory Heart Failure Trial ( RAFT ) .
RESULTS	Hospitalization rates and lengths of hospital stay were compared between the 2 groups .
RESULTS	At the 18-month follow-up , the numbers of patients hospitalized for any cause were similar in the ICD ( n = 351 , 38.8 % ) and ICD-CRT ( n = 331 , 30.0 % ) groups .
RESULTS	The number of patients hospitalized for heart failure was significantly lower in the ICD-CRT ( n = 101 , 11.3 % ) compared with the ICD ( n = 141 , 15.6 % ; P = 0.003 ) group .
RESULTS	The number of patients hospitalized for a device-related indication was similar in the ICD-CRT group ( n = 147 , 16.4 % ) and ICD group ( n = 126 , 13.9 % ; P = 0.148 ) .
RESULTS	The total number of hospitalizations for any cause ( n = 1448 versus n = 1553 ; P = 0.042 ) , any cardiovascular cause ( n = 667 versus n = 790 ; P = 0.017 ) , and any heart failure cause ( n = 385 versus n = 505 ; P < 0.0001 ) was significantly lower in ICD-CRT group compared with the ICD group , whereas the number of hospitalizations for device-related causes was significantly higher in the ICD-CRT group compared with the ICD group ( 246 versus 159 ; P < 0.001 ) .
RESULTS	Although the reduction in hospitalizations for heart failure in the CRT-ICD group was offset by an increased number of hospitalizations for device-related indications , the length of hospital stay for any cause was significantly shorter in the ICD-CRT group ( 8.8313.30 days ) compared with the ICD group ( 9.5914.40 days ; P = 0.005 ) .
CONCLUSIONS	ICD-CRT therapy significantly reduces hospitalizations and total days in hospital in patients with New York Heart Association class II/III heart failure compared with ICD therapy despite increased admissions for device-related indications .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00251251 .

###24645687
BACKGROUND	BMT CTN 1101 is a Phase III randomized controlled trial evaluating the comparative effectiveness of double unrelated umbilical cord blood ( dUCB ) versus HLA-haploidentical related donor bone marrow ( haplo-BM ) donor cell sources for blood or bone marrow transplantation ( BMT ) in patients with hematologic malignancies .
BACKGROUND	Herein , we present the rationale , design and methods of the first cost-effectiveness analysis to be conducted alongside a BMT trial .
METHODS	Consenting patients will provide health insurance information to allow calculation of direct medical costs from reimbursement records , and will provide out-of-pocket costs , time costs and health-related quality of life measures through an online survey .
METHODS	These outcomes will inform a cost-effectiveness analysis comparing dUCB and haplo-BM donor cell sources from patient , payer and societal perspectives .
CONCLUSIONS	Novel approaches may significantly change the cost , outcomes or availability of BMT .
CONCLUSIONS	The results of this analysis will be the first to provide a comprehensive evaluation of the comparative effectiveness of these approaches from multiple perspectives .

###25027229
BACKGROUND	Although hypercholesterolemia is considered a cardiovascular risk factor , in isolation it is not necessarily sufficient cause for a cardiovascular event .
BACKGROUND	To improve event prediction , cardiovascular risk calculators have been developed ; the REGICOR calculator has been validated for use in our population .
BACKGROUND	The objective of this project is to develop an intervention with general practitioners ( GPs ) and evaluate its impact on prescription adequacy of cholesterol-lowering drugs in primary prevention of cardiovascular disease and in controlling the costs associated with this disease .
METHODS	This nonblinded , cluster-randomized clinical trial analyzes data from primary care electronic medical records ( ECAP ) and other databases .
METHODS	Inclusion criteria are patients aged 35 to 74years with no known cardiovascular disease and a new prescription for cholesterol-lowering drugs during the 2-year study period .
METHODS	Dependent variables include the following : RETIRA , defined as new cholesterol-lowering drugs initiated during the year preceding the intervention , considered inadequate , and withdrawn during the study period ; EVITA , defined as new cholesterol-lowering drugs initiated during the study period and considered inadequate ; COST , defined as the total cost of inadequate new treatments prescribed ; and REGISTER , defined as the recording of cardiovascular risk factors .
METHODS	Independent variables include the GP 's quality-of-care indicators and randomly assigned study group ( intervention vs control ) , patient demographics , and clinical variables .
METHODS	Aggregated descriptive analysis will be done at the GP level and multilevel analysis will be performed to estimate the intervention effect , adjusted for individual and GP variables .
CONCLUSIONS	The study objective is to generate evidence about the effectiveness of implementing feedback information programs directed to GPs in the context of Primary Care .
CONCLUSIONS	The goal is to improve the prescription adequacy of lipid-lowering therapies for primary prevention .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01997671 .
BACKGROUND	November 28 , 2013 .

###25877495
BACKGROUND	Increased brain atrophy rates are common in older people with cognitive impairment , particularly in those who eventually convert to Alzheimer disease .
BACKGROUND	Plasma concentrations of omega-3 ( -3 ) fatty acids and homocysteine are associated with the development of brain atrophy and dementia .
OBJECTIVE	We investigated whether plasma -3 fatty acid concentrations ( eicosapentaenoic acid and docosahexaenoic acid ) modify the treatment effect of homocysteine-lowering B vitamins on brain atrophy rates in a placebo-controlled trial ( VITACOG ) .
METHODS	This retrospective analysis included 168 elderly people ( 70 y ) with mild cognitive impairment , randomly assigned either to placebo ( n = 83 ) or to daily high-dose B vitamin supplementation ( folic acid , 0.8 mg ; vitamin B-6 , 20 mg ; vitamin B-12 , 0.5 mg ) ( n = 85 ) .
METHODS	The subjects underwent cranial magnetic resonance imaging scans at baseline and 2 y later .
METHODS	The effect of the intervention was analyzed according to tertiles of baseline -3 fatty acid concentrations .
RESULTS	There was a significant interaction ( P = 0.024 ) between B vitamin treatment and plasma combined -3 fatty acids ( eicosapentaenoic acid and docosahexaenoic acid ) on brain atrophy rates .
RESULTS	In subjects with high baseline -3 fatty acids ( > 590 mol/L ) , B vitamin treatment slowed the mean atrophy rate by 40.0 % compared with placebo ( P = 0.023 ) .
RESULTS	B vitamin treatment had no significant effect on the rate of atrophy among subjects with low baseline -3 fatty acids ( < 390 mol/L ) .
RESULTS	High baseline -3 fatty acids were associated with a slower rate of brain atrophy in the B vitamin group but not in the placebo group .
CONCLUSIONS	The beneficial effect of B vitamin treatment on brain atrophy was observed only in subjects with high plasma -3 fatty acids .
CONCLUSIONS	It is also suggested that the beneficial effect of -3 fatty acids on brain atrophy may be confined to subjects with good B vitamin status .
CONCLUSIONS	The results highlight the importance of identifying subgroups likely to benefit in clinical trials .
CONCLUSIONS	This trial was registered at www.controlled-trials.com as ISRCTN94410159 .

###25362220
BACKGROUND	There are some clinical trials showing that short-term ischemia in one organ can protect different organs against higher intensity and longer ischemic insult .
BACKGROUND	We designed a study to assess whether remote ischemic preconditioning ( RIPC ) on one organ can decrease the rate of contrast-induced acute kidney injury ( AKI ) in diabetic patients who undergo coronary artery angiography ( CAA ) .
METHODS	This randomized control trial included 96 diabetic patients who were candidates for CAA .
METHODS	Exclusion criteria were congestive heart failure and complications during CAA .
METHODS	All of the patients received 1000 mL of normal saline before CAA .
METHODS	The RIPC group underwent 3 cycles of 5-minute ischemia in their right arm .
METHODS	Serum creatinine was measured before and 24 hours after CAA .
RESULTS	Contrast-induced AKI was reported in 5 cases in the control group and 1 case in the RIPC group ( P = .13 , odds ratio , 5.4 ) .
RESULTS	The differences in serum creatinine level before and after the procedure was significantly lower in RIPC group than that in the control group ( P = .04 , odds ratio , 0.08 ) .
RESULTS	Serum creatinine rise significantly correlated with contrast dose ( P = .02 ) and a history of hypertension ( P = .02 ) in both groups .
CONCLUSIONS	Ischemic preconditioning had a protective effect on contrast-induced AKI in our study .
CONCLUSIONS	Since this method is harmless and cost effective , further studies on patients with chronic kidney disease is required to evaluate addition of ischemic preconditioning to our clinical practice for prevention of contrast-induced AKI .

###25163498
BACKGROUND	Cardiovascular diseases ( CVDs ) are an increasing health problem all over the world .
BACKGROUND	The search for natural hypolipidemic agents that can be used besides the synthetic drugs is still in its experimental stage .
BACKGROUND	Plant seeds , particularly flaxseed ( Linum usitatissimum ) , which is a rich source of n-3 fatty acids , lignans and phenolic compounds , have also received increasing attention for their potential role in preventing lipid disorders .
BACKGROUND	The present study was undertaken to evaluate the therapeutic potential of flaxseeds in dyslipidemia .
METHODS	The study included 50 dyslipidemic subjects selected by purposive random sampling and were divided into two groups , a control and an experimental group .
METHODS	Both the groups were prescribed similar dietary guidelines .
METHODS	Subjects in the experimental group received 30 g of roasted flaxseed powder for 3 months .
METHODS	Anthropometric parameters , blood pressure , and blood lipid profile were estimated before the study and after completion of the study .
RESULTS	Flaxseed supplementation resulted in a remarkable improvement in anthropometric measurements , blood pressure , and lipid profile in the experimental group .
RESULTS	Body weight and body mass index ( BMI ) of the experimental group were significantly reduced ( p < 0.01 ) .
RESULTS	A lowering of systolic and diastolic blood pressure ( p < 0.05 ) was also recorded in the dyslipidemic subjects .
RESULTS	Concomitantly , a highly significant reduction ( p < 0.01 ) in total cholesterol , triglycerides , low density lipoprotein-cholesterol ( LDL-C ) , and very low density lipoprotein-cholesterol ( VLDL-C ) levels , with simultaneous elevation ( p < 0.01 ) in high density lipoprotein-cholesterol ( HDL-C ) levels was observed .
RESULTS	Improvement in lipid levels resulted in reduction of atherogenic indices .
CONCLUSIONS	The supplementation of roasted flaxseed powder for 3 months improved the BMI , blood pressure , and lipid profile of dyslipidemic subjects , thus exhibiting cardio protective effect .

###24953333
BACKGROUND	In the Iressa Pan-ASia Study ( IPASS ) , gefitinib claimed improved progression-free survival ( PFS ) versus carboplatin-paclitaxel in clinically selected lung cancer patients .
BACKGROUND	The primary objective of this study was to assess the PFS of pemetrexed-cisplatin ( PC ) followed by gefitinib maintenance versus gefitinib monotherapy in an IPASS-like population .
METHODS	In this open-label , randomised , phase 3 trial , eligible patients were 18 years , chemonave , East Asian , light ex-smokers/never-smokers with advanced non-squamous non-small cell lung cancer , an Eastern Cooperative Oncology Group ( ECOG ) performance status 0-1 and unknown epidermal growth factor receptor ( EGFR ) mutation status who enrolled at 12 sites in Asia .
METHODS	Patients randomly received ( 1:1 ) pemetrexed ( 500 mg/m ( 2 ) ) plus cisplatin ( 75mg/m ( 2 ) ) for six 21-day cycles , followed by gefitinib maintenance or gefitinib monotherapy ( 250 mg/day ) .
METHODS	Patient tissue was retrospectively analysed for EGFR mutations .
METHODS	This study is registered with ClinicalTrials.gov , NCT01017874 .
RESULTS	Between 23rd November 2009 and 27th April 2012 , 253 patients entered , and 236 patients were randomly assigned to and treated with PC therapy ( N = 114 ) and gefitinib monotherapy ( N = 118 ) .
RESULTS	Between-arm baseline characteristics were balanced .
RESULTS	PFS was not significantly different between treatment arms ( p = 0.217 ) .
RESULTS	The unadjusted hazard ratio ( HR ) was 0.85 ( 95 % confidence interval ( CI ) 0.63-1 .13 ) .
RESULTS	The HR should be cautiously interpreted as it was not constant .
RESULTS	EGFR mutation status was determined for 74 tissue samples ; 50 ( 67.6 % ) had mutations .
RESULTS	In a pre-specified subgroup analysis , only the treatment-by-EGFR mutation interaction was significant ( p = 0.008 ) for PFS .
RESULTS	For the entire treatment period , a higher proportion of patients in the PC/gefitinib arm versus gefitinib experienced possibly drug-related grade 3-4 treatment-emergent adverse events ( 39 of 114 [ 34 % ] versus 19 of 118 [ 16 % ] ; p = 0.002 ) .
CONCLUSIONS	In the intention-to-treat ( ITT ) population , PFS was not significantly different .
CONCLUSIONS	In the biomarker-assessable population , front-line EGFR tyrosine kinase inhibitor monotherapy was not efficacious in patients with wild-type EGFR .
CONCLUSIONS	Identification of EGFR mutation status is key in the management of advanced non-squamous non-small cell lung cancer .
BACKGROUND	Eli Lilly and Company .

###24894651
OBJECTIVE	To determine whether EMD 1201081 , a TLR9 agonist , added to cetuximab had antitumor activity in second-line recurrent/metastatic squamous cell carcinoma of the head and neck ( R/M SCCHN ) .
METHODS	This was a phase 2 , open-label , randomized trial of EMD 1201081 0.32 mg/kg subcutaneously weekly plus cetuximab ( combination ) vs cetuximab monotherapy ( control ) in cetuximab-nave patients with R/M SCCHN who progressed on 1 cytotoxic regimen .
METHODS	Crossover to combination was permitted after progression .
RESULTS	Objective response rate in both arms was 5.7 % ( 95 % CI 1.2-15 .7 % ) by independent assessment .
RESULTS	Disease control was 37.7 % for patients on combination ( 24.8-52 .1 % ) and 43.4 % on control ( 29.8-57 .7 % ) .
RESULTS	Neither independent nor investigator assessments showed significant differences between study arms .
RESULTS	Median progression-free survival was 1.5 months ( 1.3-2 .6 ) for patients on combination , and 1.9 months ( 1.5-2 .9 ) on control .
RESULTS	The most frequent adverse events in the combination arm were rash ( 29.6 % ) , acneiform dermatitis ( 22.2 % ) , and injection site reactions ( 20.4 % ) .
RESULTS	Grade 3/4 dyspnea and hypokalemia were more frequent with cetuximab monotherapy ( 7.5 % and 5.7 % vs 1.9 % each , respectively ) , and grade 3/4 respiratory failure and disease progression were more frequent with combination ( 5.6 % each vs 1.9 % each ) .
CONCLUSIONS	EMD 1201081 was well tolerated combined with cetuximab , but there was no incremental clinical efficacy .

###25701273
BACKGROUND	Mammography screening can reduce breast cancer mortality .
BACKGROUND	However , most women are unaware that inconsequential disease can also be detected by screening , leading to overdiagnosis and overtreatment .
BACKGROUND	We aimed to investigate whether including information about overdetection of breast cancer in a decision aid would help women aged around 50 years to make an informed choice about breast screening .
METHODS	We did a community-based , parallel-group , randomised controlled trial in New South Wales , Australia , using a random cohort of women aged 48-50 years .
METHODS	Recruitment to the study was done by telephone ; women were eligible if they had not had mammography in the past 2 years and did not have a personal or strong family history of breast cancer .
METHODS	With a computer program , we randomly assigned 879 participants to either the intervention decision aid ( comprising evidence-based explanatory and quantitative information on overdetection , breast cancer mortality reduction , and false positives ) or a control decision aid ( including information on breast cancer mortality reduction and false positives ) .
METHODS	Participants and interviewers were masked to group assignment .
METHODS	The primary outcome was informed choice ( defined as adequate knowledge and consistency between attitudes and screening intentions ) , which we assessed by telephone interview about 3 weeks after random allocation .
METHODS	The primary outcome was analysed in all women who completed the relevant follow-up interview questions fully .
METHODS	This trial is registered with the Australian New Zealand Clinical Trials Registry , number ACTRN12613001035718 .
RESULTS	Between January , 2014 , and July , 2014 , 440 women were allocated to the intervention group and 439 were assigned to the control group .
RESULTS	21 women in the intervention group and 20 controls were lost to follow-up ; a further ten women assigned to the intervention and 11 controls did not answer all questions on attitudes .
RESULTS	Therefore , 409 women in the intervention group and 408 controls were analysed for the primary outcome .
RESULTS	99 ( 24 % ) of 409 women in the intervention group made an informed choice compared with 63 ( 15 % ) of 408 in the control group ( difference 9 % , 95 % CI 3-14 ; p = 00017 ) .
RESULTS	Compared with controls , more women in the intervention group met the threshold for adequate overall knowledge ( 122/419 [ 29 % ] vs 71/419 [ 17 % ] ; difference 12 % , 95 % CI 6-18 ; p < 00001 ) , fewer women expressed positive attitudes towards screening ( 282/409 [ 69 % ] vs 340/408 [ 83 % ] ; 14 % , 9-20 ; p < 00001 ) , and fewer women intended to be screened ( 308/419 [ 74 % ] vs 363/419 [ 87 % ] ; 13 % , 8-19 ; p < 00001 ) .
RESULTS	When conceptual knowledge alone was considered , 203 ( 50 % ) of 409 women in the intervention group made an informed choice compared with 79 ( 19 % ) of 408 in the control group ( p < 00001 ) .
CONCLUSIONS	Information on overdetection of breast cancer provided within a decision aid increased the number of women making an informed choice about breast screening .
CONCLUSIONS	Becoming better informed might mean women are less likely to choose screening .
BACKGROUND	Australian National Health and Medical Research Council .

###24958910
BACKGROUND	Vaccine efficacy ( VE ) against vulvar human papillomavirus ( HPV ) infection has not been reported and data regarding its epidemiology are sparse .
METHODS	Women ( n = 5404 ) age 22-29 present at the 4-year study visit of the Costa Rica Vaccine Trial provided vulvar and cervical samples .
METHODS	A subset ( n = 1044 ) was tested for HPV DNA ( SPF10/LiPA25 version 1 ) .
METHODS	VE against 1-time detection of vulvar HPV16/18 among HPV vaccinated versus unvaccinated women was calculated and compared to the cervix .
METHODS	Prevalence of and risk factors for HPV were evaluated in the control arm ( n = 536 ) .
RESULTS	Vulvar HPV16/18 VE ( 54.1 % ; 95 % confidence interval [ CI ] , 4.9 % -79.1 % ) was comparable to cervix ( 45.8 % ; 95 % CI , 6.4 % -69.4 % ) .
RESULTS	Vulvar and cervical HPV16 prevalence within the control arm was 3.0 % and 4.7 % , respectively .
RESULTS	Independent risk factors for vulvar HPV were similar to cervix and included : age ( adjusted odds ratio [ aOR ] 0.5 [ 95 % CI , .3 -.9 ] 28 vs 22-23 ] ) ; marital status ( aOR 2.3 [ 95 % CI , 1.5-3 .5 ] single vs married/living-as-married ) ; and number of sexual partners ( aOR 3.6 [ 95 % CI , 1.9-7 .0 ] 6 vs 1 ) .
CONCLUSIONS	In this intention-to-treat analysis , VE against vulvar and cervical HPV16/18 were comparable 4 years following vaccination .
CONCLUSIONS	Risk factors for HPV were similar by anatomic site .
BACKGROUND	NCT00128661 .

###24996573
BACKGROUND	Forty percent of in-hospital deaths among injured patients involve massive truncal haemorrhage .
BACKGROUND	These deaths may be prevented with rapid haemorrhage control and improved resuscitation techniques .
BACKGROUND	The Pragmatic Randomized Optimal Platelet and Plasma Ratios ( PROPPR ) Trial was designed to determine if there is a difference in mortality between subjects who received different ratios of FDA approved blood products .
BACKGROUND	This report describes the design and implementation of PROPPR .
METHODS	PROPPR was designed as a randomized , two-group , Phase III trial conducted in subjects with the highest level of trauma activation and predicted to have a massive transfusion .
METHODS	Subjects at 12 North American level 1 trauma centres were randomized into one of two standard transfusion ratio interventions : 1:1:1 or 1:1:2 , ( plasma , platelets , and red blood cells ) .
METHODS	Clinical data and serial blood samples were collected under Exception from Informed Consent ( EFIC ) regulations .
METHODS	Co-primary mortality endpoints of 24h and 30 days were evaluated .
RESULTS	Between August 2012 and December 2013 , 680 patients were randomized .
RESULTS	The overall median time from admission to randomization was 26min .
RESULTS	PROPPR enrolled at higher than expected rates with fewer than expected protocol deviations .
CONCLUSIONS	PROPPR is the largest randomized study to enrol severely bleeding patients .
CONCLUSIONS	This study showed that rapidly enrolling and successfully providing randomized blood products to severely injured patients in an EFIC study is feasible .
CONCLUSIONS	PROPPR was able to achieve these goals by utilizing a collaborative structure and developing successful procedures and design elements that can be part of future trauma studies .

###24221839
BACKGROUND	The benefits of medication adherence to control cardiovascular disease ( CVD ) are well defined , yet multiple studies have identified poor adherence .
BACKGROUND	The influence of life chaos on medication adherence is unknown .
BACKGROUND	Because this is a novel application of an instrument , our preliminary objective was to understand patient factors associated with chaos .
BACKGROUND	The main objective was to evaluate the extent to which an instrument designed to measure life chaos is associated with CVD-medication nonadherence .
RESULTS	Using baseline data from an ongoing randomized trial to improve postmyocardial infarction ( MI ) management , multivariable logistic regression identified the association between life chaos and CVD-medication nonadherence .
RESULTS	Patients had hypertension and a myocardial infarction in the past 3 years ( n = 406 ) .
RESULTS	Nearly 43 % reported CVD-medication nonadherence in the past month .
RESULTS	In simple linear regression , the following were associated with higher life chaos : medication nonadherence ( = 1.86 ; 95 % confidence interval [ CI ] , 0.96-2 .76 ) , female sex ( = 1.22 ; 95 % CI [ 0.22-2 .24 ] ) , minority race ( = 1.72 ; 95 % CI [ 0.78-2 .66 ] ) , having less than high school education ( = 2.05 ; 95 % CI [ 0.71-3 .39 ] ) , low health literacy ( = 2.06 ; 95 % CI [ 0.86-3 .26 ] ) , and inadequate financial status ( = 1.93 ; 95 % CI [ 0.87-3 .00 ] ) .
RESULTS	Being married ( = -2.09 , 95 % CI [ -3.03 to -1.15 ] ) was associated with lower life chaos .
RESULTS	As chaos quartile increased , patients exhibited more nonadherence .
RESULTS	In logistic regression , adjusting for sex , race , marital status , employment , education , health literacy , and financial status , a 1-unit life chaos increase was associated with a 7 % increase ( odds ratio , 1.07 ; 95 % CI [ 1.02-1 .12 ] ) in odds of reporting medication nonadherence .
CONCLUSIONS	Our results suggest that life chaos may be an important determinant of medication adherence .
CONCLUSIONS	Life chaos screenings could identify those at risk for nonadherence .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT000901277 .

###24977293
OBJECTIVE	The principal study objective was to investigate the pharmacokinetic characteristics of a new sublingual ketamine wafer and to establish its absolute bioavailability and local tolerability .
METHODS	The study was of open label , two way randomized crossover design in eight healthy male volunteers .
METHODS	Each participant received either a single 10 mg intravenous dose as a constant rate 30 min infusion or a 25mg sublingual dose of ketamine wafer in two treatment periods with a 7 day wash out .
METHODS	Pharmacokinetic blood sampling and local tolerability and safety assessments were carried out during 24 h following both dosing occasions .
METHODS	Plasma concentrations were analyzed by non-compartmental methods and local tolerability was assessed using modified Likert scales .
RESULTS	The median ( 90 % CI lower , upper limit ) absolute bioavailability of sublingual ketamine was 29 % ( 27 , 31 % ) .
RESULTS	The first quantifiable plasma ketamine concentration was observed within 5 min for all eight participants for both routes of administration and the median ( minmax ) time of the peak plasma concentration was 0.75 h ( 0.251.0 h ) after sublingual administration .
RESULTS	The ketamine wafer had very good local tolerability .
CONCLUSIONS	Sublingual administration of the ketamine wafer resulted in rapid absorption .
CONCLUSIONS	The ketamine wafer has comparable bioavailability with other oral transmucosal formulations of ketamine but with markedly reduced inter-subject variability , warranting further evaluation as an analgesic adjunct .

###25576215
BACKGROUND	Many patients with chronic kidney disease ( CKD ) are hyporesponsive to currently licensed alum-adjuvanted hepatitis B vaccines , including Engerix-B ( ) ( HBsAg-Eng ) .
BACKGROUND	Seroprotection rates ( SPRs ) are further reduced in CKD patients with diabetes mellitus .
BACKGROUND	Three doses of an investigational hepatitis B vaccine ( HBsAg-1018 ) that uses a Toll-like receptor 9 agonist demonstrated superior SPRs to 4 double doses of HBsAg-Eng in a large phase 3 trial of CKD patients .
METHODS	A prespecified subgroup analysis of immunogenicity was conducted in CKD participants with type 2 diabetes in the phase 3 trial .
RESULTS	In 328 participants , the peak SPR in the HBsAg-1018 group met criteria for noninferiority and superiority to the peak SPR in the HBsAg-Eng group .
RESULTS	The peak geometric mean concentration of antibody against hepatitis B surface antigen in the HBsAg-1018 group was statistically significantly higher than in the HBsAg-Eng group .
CONCLUSIONS	HBsAg-1018 induced significantly higher seroprotection than HBsAg-Eng in CKD patients with diabetes .

###25526873
OBJECTIVE	Autologous blood transfusion from the placenta to the neonate at birth has been proven beneficial .
OBJECTIVE	Transfusion can be accomplished by either delayed cord clamping or cord stripping .
OBJECTIVE	Both are equally effective in previous randomized trials .
OBJECTIVE	We hypothesized that combining these 2 techniques would further improve outcomes in preterm neonates .
METHODS	This was a prospective randomized trial for singleton deliveries with estimated gestational ages between 22 and 31 6/7 weeks .
METHODS	The control protocol required a 30-second delayed cord clamping , whereas the test protocol instructed a concurrent cord stripping during the delay .
METHODS	The primary outcome was initial fetal hematocrit .
METHODS	We also examined secondary outcomes of neonatal mortality , length of time on the ventilator , days to discharge , peak bilirubin , number of phototherapy days , and neonatal complication rates .
RESULTS	Of the 67 patients analyzed , 32 were randomized to the control arm and 35 were randomized to the test arm .
RESULTS	The gestational ages and fetal weights were similar between the arms .
RESULTS	Mean hematocrit of the control arm was 47.75 % , and the mean hematocrit for the test arm was 47.71 % ( P = .98 ) .
RESULTS	These results were stratified by gestational age , revealing the infants less than 28 weeks had an average hematocrit of 41.2 % in the control arm and 44.7 % in the test arm ( P = .12 ) .
RESULTS	In the infants with gestational ages of 28 weeks or longer , the control arm had an average hematocrit of 52.9 % , which was higher than the test arm , which averaged 49.5 % ( P = .04 ) .
RESULTS	The control arm received an average of 1.53 blood transfusions , whereas the test arm received 0.97 ( P = .33 ) .
RESULTS	The control arm had 3 neonatal deaths , and the test arm had none ( P = .10 ) .
RESULTS	The average number of days until discharge was 71.2 for the control arm and 67.8 for the test arm ( P = .66 ) .
RESULTS	The average number of days on the ventilator was 4.86 for the control arm and 3.06 for the test arm ( P = .34 ) .
CONCLUSIONS	Adding cord stripping to the delayed cord clamp does not result in an increased hematocrit .
CONCLUSIONS	Data suggest trends in lower mortality and higher hematocrit in neonates born less than 28 weeks , but these were not statistically significant .

###24345385
OBJECTIVE	Patients with diabetes mellitus have a higher risk of adverse events after percutaneous coronary intervention ( PCI ) .
OBJECTIVE	This study aimed to elucidate the relative efficacy of everolimus-eluting stents ( EES ) versus sirolimus-eluting stents ( SES ) according to diabetic status .
RESULTS	Data from the EXCELLENT randomised trial and registry were pooled in a per protocol analysis manner .
RESULTS	The primary endpoint was target lesion failure ( TLF ) , a composite of cardiac death , target vessel-related myocardial infarction , or target vessel revascularisation .
RESULTS	Among a total of 6,524 patients , 2,404 ( 36.8 % ) had diabetes mellitus .
RESULTS	Patients with diabetes were shown to have a higher rate of TLF after PCI , which was mainly driven by differences in cardiac death and myocardial infarction , while the rate of repeat revascularisation and stent thrombosis did not differ significantly .
RESULTS	TLF occurred at a similar rate between patients treated with EES versus SES in each subgroup stratified by diabetic status ( interaction p = 0.384 ) .
RESULTS	In addition , no significant interactions were present with regard to any pre-specified clinical endpoints .
RESULTS	The results were corroborated by analysis with inverse probability of treatment weighting ( interaction p = 0.329 ) .
RESULTS	We also found that insulin-dependent diabetes imposed an even greater risk of TLF on patients treated with PCI .
CONCLUSIONS	Despite the recent advances in drug-eluting stent technology , diabetic patients are still at higher risk of adverse clinical events after PCI than those without diabetes mellitus .
CONCLUSIONS	Whether a patient was treated with EES or SES had no significant interaction with diabetic status in terms of clinical outcome after PCI .

###25087837
OBJECTIVE	To evaluate the effectiveness of an interactive videogame ( IV ) system in addition to a supervised pulmonary rehabilitation programme ( PRP ) in patients with chronic respiratory diseases .
METHODS	Randomised Controlled Trial comparing standard PRP ( 20 patients , control group : CG ) , and PRP + sessions of interactive videogame-aided exercises ( 20 patients , experimental group : EG ) .
METHODS	Lung and respiratory muscle function , arterial blood gases , exercise capacity , dyspnoea , health status and health-related quality of life ( HRQL ) and emotional response were measured before and after PRP .
METHODS	A questionnaire on acceptability of the PRP was administered .
RESULTS	Exercise capacity , dyspnoea and HRQL significantly improved in both groups after the PRP , whereas the EG showed a greater improvement in six-minute walk test and transitional dyspnoea index than the CG .
RESULTS	No difference in psychological status or acceptability of PRP was observed between the two groups .
CONCLUSIONS	The addition of IV training was more effective for improving some parameters of exercise tolerance and dyspnoea , although did not result in better psychological status nor it was better accepted than the standard PRP in patients with chronic respiratory diseases .

###24736093
OBJECTIVE	High attendance rates in cervical screening are essential for effective cancer prevention .
OBJECTIVE	Offering HPV self-sampling to non-responders increases participation rates .
OBJECTIVE	The objectives of this study were to determine why non-responders do not attend regular screening , and why they do or do not participate when offered a self-sampling device .
METHODS	A questionnaire study was conducted in the Netherlands from October 2011 to December 2012 .
METHODS	A total of 35,477 non-responders were invited to participate in an HPV self-sampling study ; 5347 women did opt out .
METHODS	Finally , 30,130 women received a questionnaire and self-sampling device .
RESULTS	The analysis was based on 9484 returned questionnaires ( 31.5 % ) with a self-sample specimen , and 682 ( 2.3 % ) without .
RESULTS	Among women who returned both , the main reason for non-attendance to cervical screening was that they forgot to schedule an appointment ( 3068 ; 32.3 % ) .
RESULTS	The most important reason to use the self-sampling device was the opportunity to take a sample in their own time-setting ( 4763 ; 50.2 % ) .
RESULTS	A total of 30.9 % of the women who did not use the self-sampling device preferred after all to have a cervical smear taken instead .
CONCLUSIONS	Organisational barriers are the main reason for non-attendance in regular cervical screening .
CONCLUSIONS	Important reasons for non-responders to the regular screening to use a self-sampling device are convenience and self-control .

###24699551
OBJECTIVE	Myocardial injury commonly occurs during percutaneous coronary intervention ( PCI ) .
OBJECTIVE	Several agents that mimic ischemic preconditioning could help minimize this phenomenon .
OBJECTIVE	This study evaluated the cardio-protective role of intracoronary Adenosine in elective PCI .
METHODS	A total of 100 diabetic patients with chronic stable angina were prospectively enrolled , then randomly assigned to undergo PCI with intracoronary Adenosine ; 100 g/stented vessel ( group-A , 50 patients ) or standard PCI ( group-B , 50 patients ) .
METHODS	Cardiac troponin I ( cTnI ) and creatine kinase-MB ( CK-MB ) levels were measured before and 6 , 12 and 24 hours post-PCI .
RESULTS	Mean age of the study cohort was 578 years ( males = 63 % ) .
RESULTS	cTnI level was significantly lower in group-A ( 6 hours : 7.50.2 vs. 15.50.5 pg/mL , 12 hours : 13.70.7 vs. 25.50.6 pg/mL and 24 hours : 7.60.5 vs. 160.3 pg/mL , P < 0.001 ) .
RESULTS	After 3 months , the same group showed significantly higher left ventricle ejection fraction ( LVEF % ) , i.e. 64.55.7 vs. 56.55.3 ( P < 0.05 ) .
RESULTS	There was no statistically significant difference between both groups of patients regarding incidence of major adverse cardiac events ( MACE ) .
CONCLUSIONS	In diabetic patients undergoing elective PCI , intracoronary Adenosine was associated with decreased incidence of PCI-related myocardial injury & improvement of LVEF % after 3 months .

###24915562
OBJECTIVE	Since probiotics modulate intestinal functions and enterohepatic circulation ; they might have an effect on neonatal hyperbilirubinemia treatment .
OBJECTIVE	The objective of this study was to investigate the efficacy of Saccharomyces boulardii supplementation on hyperbilirubinemia .
METHODS	A prospective , double-blind , placebo controlled trial was performed on 35 to 42 gestational weeks ' neonates .
METHODS	They were randomized either to receive feeding supplementation with S. boulardii 125mg every 12 hours or placebo during phototherapy .
METHODS	Serum bilirubin levels were measured at 0 , 24th , 48th , 72nd , and 96th hour of phototherapy .
RESULTS	A total of 119 infants ( 61 in the control group and 58 in the study group ) were enrolled .
RESULTS	The duration of phototherapy ( 2 [ 1-3 ] vs. 2 [ 1-3 ] , p : 0.22 ) was not different between groups .
RESULTS	The levels of bilirubin during phototherapy ( [ 24th hour ; 14.1 { 12.8-15 .7 } vs. 13.5 { 12.4-14 .9 } , p : 0.085 ] ; [ 48th hour ; 14.1 { 12-15 .3 } vs. 13.4 { 12.4-14 .5 } , p : 0.41 ] ; [ 72nd hour ; 13.9 { 12.2-15 .6 } vs. 13.5 { 12.5-14 .5 } , p : 0.41 ] ; [ 96th hour ; 14.7 { 11.4-15 .5 } vs. 13.4 { 10.7-14 .1 } , p : 0.24 ] ) or the duration of rebound phototherapy ( 1 [ 1-1 ] vs. 1.5 [ 1-2 ] , p : 0.40 ) were lower in the study group than in the controls , but none of the values were statistically significant .
CONCLUSIONS	S. boulardii did not influence the clinical course of hyperbilirubinemia significantly .

###24355115
OBJECTIVE	This study sought to investigate the impact of left main coronary artery ( LMCA ) 3-dimensional ( 3D ) bifurcation angle ( BA ) parameters on 5-year clinical outcomes of patients randomized to LMCA percutaneous coronary intervention ( PCI ) in the SYNTAX ( Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery ) trial .
BACKGROUND	BA can affect outcome after bifurcation PCI ; 3D angiographic analysis provides reliable BA measurements .
METHODS	The diastolic distal BA ( between left anterior descending and left circumflex ) and its systolic-diastolic range were explored .
METHODS	A stratified post-hoc survival analysis was performed for 5-year major adverse cardiac and cardiovascular events ( MACCE ) ( all-cause death , cerebrovascular accident , myocardial infarction , or repeat revascularization ) , a safety endpoint ( all-cause death , cerebrovascular accident , or myocardial infarction ) , and repeat revascularization .
METHODS	Analysis was performed in patients where 3D BA was available pre - and post-PCI .
RESULTS	Of 266 patients eligible for analysis , 185 underwent bifurcation PCI ( group B ) ; 1 stent was used in 75 patients ( group B1 ) , whereas 2 stents were used in 110 patients ( group B2 ) .
RESULTS	Stratification across pre-PCI diastolic distal BA tertiles ( < 82 , 82 to 106 , 107 ) failed to show any difference in MACCE rates either in the entire study population ( p = 0.99 ) or in group B patients ( p = 0.78 ) .
RESULTS	Group B patients with post-PCI systolic-diastolic range < 10 had significantly higher MACCE rates ( 50.8 % vs. 22.7 % , p < 0.001 ) ; repeat revascularization and safety endpoint rates were also higher ( 37.4 % vs. 15.5 % , p = 0.002 , and 25.4 % vs. 14.1 % , p = 0.055 , respectively ) .
RESULTS	Post-PCI systolic-diastolic range < 10 was an independent predictor of MACCE ( hazard ratio : 2.65 ; 95 % confidence interval : 1.55 to 4.52 ; p < 0.001 ) in group B patients .
CONCLUSIONS	A restricted post-procedural systolic-diastolic distal BA range resulted in higher 5-year adverse event rates after LMCA bifurcation PCI .
CONCLUSIONS	Pre-PCI BA value did not affect the clinical outcome .

###24282209
OBJECTIVE	To examine with a parallel group study design the performance and physiological responses to a 14-day off-season ` live high-train low in the heat ' training camp in elite football players .
METHODS	Seventeen professional Australian Rules Football players participated in outdoor football-specific skills ( 32 1C , 11.5 h ) and indoor strength ( 23 1C , 9.3 h ) sessions and slept ( 12 nights ) and cycled indoors ( 4.3 h ) in either normal air ( NORM , n = 8 ) or normobaric hypoxia ( 14 1 h/day , FiO2 15.2-14 .3 % , corresponding to a simulated altitude of 2500-3000 m , hypoxic ( HYP ) , n = 9 ) .
METHODS	They completed the Yo-Yo Intermittent Recovery level 2 ( Yo-YoIR2 ) in temperate conditions ( 23 1C , normal air ) precamp ( Pre ) and postcamp ( Post ) .
METHODS	Plasma volume ( PV ) and haemoglobin mass ( Hb ( mass ) ) were measured at similar times and 4 weeks postcamp ( 4WPost ) .
METHODS	Sweat sodium concentration ( ( Na ( + ) ) ( sweat ) ) was measured Pre and Post during a heat-response test ( 44C ) .
RESULTS	Both groups showed very large improvements in Yo-YoIR2 at Post ( +44 % ; 90 % CL 38 , 50 ) , with no between-group differences in the changes ( -1 % ; -9 , 9 ) .
RESULTS	Postcamp , large changes in PV ( +5.6 % ; -1.8 , 5.6 ) and ( Na ( + ) ) sweat ( -29 % ; -37 , -19 ) were observed in both groups , while Hb ( mass ) only moderately increased in HYP ( +2.6 % ; 0.5 , 4.5 ) .
RESULTS	At 4WPost , there was a likely slightly greater increase in Hb ( mass ) ( +4.6 % ; 0.0 , 9.3 ) and PV ( +6 % ; -5 , 18 , unclear ) in HYP than in NORM .
CONCLUSIONS	The combination of heat and hypoxic exposure during sleep/training might offer a promising ` conditioning cocktail ' in team sports .

###25526951
BACKGROUND	Probably related to immune dysfunction , psoriasis vulgaris is a chronic , painful , disfiguring and disabling dermatological disease , carrying an increased risk of serious comorbidities .
BACKGROUND	Current conventional therapies can be costly , show risks of side effects and have limited efficacy , with relapse common on treatment cessation .
BACKGROUND	Chinese herbal medicine is effective in treating psoriasis vulgaris .
BACKGROUND	However , any benefit of adding Chinese herbal medicine to conventional treatments when treating psoriasis vulgaris is yet to be determined .
METHODS	This is a pilot randomized , placebo controlled , double-blinded trial .
METHODS	The pilot is primarily to determine the feasibility of undertaking a full size randomized trial .
METHODS	Thirty participants with psoriasis vulgaris and Psoriasis Area Severity Index ( PASI ) scores 7 and 12 will be included .
METHODS	Participants will be randomized ( in a 1:1 ratio ) to receive oral granulated Chinese herbal medicine YXBCM01 plus topical calcipotriol 0.005 % or oral YXBCM01 placebo plus topical calcipotriol 0.005 % treatment for 12 weeks , with a 12-week follow-up phase .
METHODS	The Chinese herbal medicine or placebo will be administered orally as dissolvable granules .
METHODS	The primary outcome measure will be PASI change ( % ) from baseline to the end of treatment phase .
METHODS	Secondary outcomes will include safety , key psoriasis-related cytokine changes ( for example , IL12 , IL17 and IL 23 ) during the entire trial and symptom relapse rates at the end of the follow-up phase .
CONCLUSIONS	The study will evaluate the feasibility of a randomized controlled trial investigating combined conventional and Chinese herbal medicine therapy for psoriasis vulgaris .
CONCLUSIONS	The ingredients of YXBCM01 were selected based on literature , the expert opinion on herbal medicine and pre-clinical evidence , for instance Chinese herbal medicine possesses anti-inflammatory or antiproliferative properties .
BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12614000493640 .

###24285428
BACKGROUND	Haemodialysis patients suffer from accelerated vascular calcification .
BACKGROUND	The vitamin K-dependent matrix Gla protein ( MGP ) is one of the most powerful inhibitors of vascular calcification .
BACKGROUND	Haemodialysis patients have high levels of the inactive form of MGP ( desphosphorylated-uncarboxylated-MGP , dp-uc-MGP ) and may benefit from pharmacological doses of vitamin K2 ( menaquinone ) to improve the calcification inhibitory activity of MGP .
METHODS	To determine the optimal dose of menaquinone-7 ( MK-7 ) for MGP activation , 200 chronic haemodialysis patients were recruited to randomly receive 360 , 720 or 1080 g of MK-7 thrice weekly for 8 weeks .
METHODS	Dp-uc-MGP was measured at baseline and after 8 weeks .
METHODS	Dietary intake of vitamin K1 ( phylloquinone ) and menaquinone was estimated based on a detailed questionnaire .
RESULTS	At baseline , dp-uc-MGP was not associated with phylloquinone intake ( P = 0.92 ) , but correlated inversely with menaquinone intake ( P = 0.023 ) .
RESULTS	MK-7 supplementation dose dependently reduced dp-uc-MGP .
RESULTS	The levels decreased by 17 , 33 and 46 % in the respective groups .
RESULTS	Drop-outs were mainly due to gastrointestinal side-effects related to the unpleasant smell of the tablets .
CONCLUSIONS	Chronic haemodialysis patients have high levels of inactive MGP , possibly related to a low dietary vitamin K intake .
CONCLUSIONS	Pharmacological doses of MK-7 dose-dependently reduce dp-uc-MGP .
CONCLUSIONS	Menaquinone supplementation may be a novel approach to prevent vascular calcifications in chronic haemodialysis patients .

###25980148
OBJECTIVE	To evaluate short term quality of life of patients with chronic rhinosinusitis by using Chinese version of the sinonasal outcome test-22 ( SNOT-22 ) and to formulate an ideal therapy system for patients with chronic rhinosinusitis .
METHODS	Using prospective randomized controlled design , we chose the SNOT-22 to evaluate and compare 78 CRS patients ' quality of life ( QOL ) before surgery , at 1-month ,3 - month , 6-month and 9-month after functional endoscopic sinus surgery ( FESS ) .
METHODS	At the same time , we randomly chose 100 healthy controls to compare their QOL with those of CRS patients after FESS .
RESULTS	We found that except for 5 items ( cough , ear expanding , otalgia , facail pain and weary ) , the grade of 17 other items of CRS patients were significantly higher than those of the healthy controls ( P < 0.05 ) .
RESULTS	There was no significant difference in 7 items ( olfactory sensation , hypogeusis , backflow of nasal discharge , difficult to fall asleep , bad sleep , bad work efficiency , depression , embarrassment ) at 3 months after FESS between chronic rhinosinusitis patients and healthy controls ( P > 0.05 ) .
RESULTS	There was no significant difference in 9 items ( blow noses , sneeze , rhinorrhea , nasal discharge thickness , dizziness , night wake , tired of wake , attention deficit , sense of loss ) at 6 months after FESS between chronic rhinosinusitis patients and healthy controls ( P > 0.05 ) .
RESULTS	There was no significant difference in nasal obstruction at 6 months after FESS between chronic rhinosinusitis patients and healthy controls ( P > 0.05 ) , at this time the totle grade was normal ( P > 0.05 ) .
RESULTS	The recovery period of QOL in patients was about 9 months ( P > 0.05 ) .
RESULTS	The 5 great items were nasal obstruction , olfactory sensation , hypogeusis , nasal discharge , nasal discharge thickness and blow noses .
RESULTS	There was no difference in items except for bad sleep replacing nasal discharge thickness between 1-month and 9-month after surgery .
CONCLUSIONS	The Chinese vesion of SNOT-22 could evaluate QOL of CRS patients in this area .
CONCLUSIONS	The recovery of QOL of CRS patients needs about 6 months after FESS , but problems of olfactory sensation , hypogeusis , nasal discharge and difficult to sleeep still needs to be resolved .

###24628753
OBJECTIVE	Altered mental status ( AMS ) is a common presentation in the emergency department ( ED ) .
OBJECTIVE	A previous study revealed 78 % electroencephalogram ( EEG ) abnormalities , including nonconvulsive seizure ( NCS ; 5 % ) , in ED patients with AMS .
OBJECTIVE	The objective of this study was to assess the impact of EEG on clinical management and outcomes of ED patients with AMS .
METHODS	This was a randomized controlled trial at two urban teaching hospitals .
METHODS	Adult patients ( 18 years old ) with AMS were included .
METHODS	Excluded patients had immediately correctable AMS ( e.g. , hypoglycemia ) or were admitted before enrollment .
METHODS	Patients were randomized to routine care ( control ) or routine care plus EEG ( intervention ) .
METHODS	Research assistants used a scalp electrode set with a miniature , wireless EEG device ( microEEG ) to record standard 30-minute EEGs at presentation , and results were reported to the ED attending physician by an off-site epileptologist within 30 minutes .
METHODS	Primary outcomes included changes in ED management ( differential diagnosis , diagnostic work-up , and treatment plan from enrollment to disposition ) as determined by surveying the treating physicians .
METHODS	Secondary outcomes were length of ED and hospital stay , intensive care unit ( ICU ) requirement , and in-hospital mortality .
RESULTS	A total of 149 patients were enrolled ( 76 control and 73 intervention ) .
RESULTS	Patients in the two groups were comparable at baseline .
RESULTS	EEG in the intervention group revealed abnormal findings in 93 % ( 95 % confidence interval [ CI ] = 85 % to 97 % ) , including NCS in 5 % ( 95 % CI = 2 % to 13 % ) .
RESULTS	Using microEEG was associated with change in diagnostic work-up in 49 % ( 95 % CI = 38 % to 60 % ) of cases and therapeutic plan in 42 % ( 95 % CI = 31 % to 53 % ) of cases immediately after the release of EEG results .
RESULTS	Changes in probabilities of differential diagnoses and the secondary outcomes were not statistically significant between the groups .
CONCLUSIONS	An EEG can be obtained in the ED with minimal resources and can affect clinical management of AMS patients .

###25122976
OBJECTIVE	To compare the efficacy of an oscillating-rotating power toothbrush with a novel brush head incorporating angled CrissCross bristles ( Oral-B Triumph with SmartGuide with Oral-B CrossAction brush head ) versus a sonic toothbrush ( Sonicare DiamondClean ) for plaque and gingivitis reduction over a six-week period .
METHODS	This was a single-center , randomized , examiner-blind , two-treatment , parallel group study involving 65 subjects per group .
METHODS	Subjects presenting with mild-to-moderate gingivitis at Baseline were randomly assigned to either the oscillating-rotating brush or the sonic brush .
METHODS	They were instructed to use their assigned toothbrush and a standard fluoride dentifrice for two minutes twice daily at home for six weeks .
METHODS	Gingivitis and plaque were assessed at Baseline and Week 6 using the Modified Gingival Index ( MGI ) , Gingival Bleeding Index ( GBI ) , and Rustogi Modified Navy Plaque Index ( RMNPI ) .
METHODS	Data were analyzed using an Analysis of Covariance ( ANCOVA ) , with baseline as the covariate .
METHODS	Subjects also completed a consumer perception questionnaire to evaluate their brushing experience .
RESULTS	One-hundred and thirty subjects were enrolled in the study and randomized to treatment .
RESULTS	Sixty-four subjects per group completed the trial .
RESULTS	Both brushes produced statistically significant reductions in gingivitis and plaque measures at Week 6 relative to Baseline ( p < 0.001 for all ) .
RESULTS	The oscillating-rotating brush with the novel brush head demonstrated statistically significantly greater reductions in all gingivitis and plaque measures compared to the sonic toothbrush .
RESULTS	The benefits for the oscillating-rotating brush over the sonic brush were 32.6 % for gingivitis , 35.4 % for gingival bleeding , 32 % for number of bleeding sites , 22 % for whole mouth plaque , 24.2 % for gingival margin plaque , and 33.3 % for approximal plaque ( p < or = 0.001 for all measures except gingival margin plaque , where p = 0.018 ) .
RESULTS	Analysis of the consumer perception questionnaire results showed subjects using the oscillating-rotating brush rated it higher for overall use experience and key attributes related to cleaning , gentleness , and brush head shape/size versus subjects in the sonic brush group .
RESULTS	There were no adverse events reported or observed for either brush .
CONCLUSIONS	This six-week randomized , examiner-blind , comparative clinical study showed the oscillating-rotating toothbrush , with a novel brush head incorporating angled CrissCross bristles , was significantly better than an advanced sonic power toothbrush at reducing gingival inflammation and bleeding , as well as reducing whole mouth plaque , plaque along the gumline , and in the approximal regions .

###25022120
OBJECTIVE	To compare the differences in the efficacy on distant version of naked eye in the patients of juvenile myopia between rotating manipulation and lifting-thrusting manipulation of acupuncture .
METHODS	One hundred and twenty cases ( 240 eyes ) were randomized into a rotating manipulation group and a lifting-thrusting manipulation group , 60 cases ( 120 eyes ) in each group .
METHODS	Additionally , a corrective lenses group , 60 cases ( 120 eyes ) , was set up as the control .
METHODS	In both manipulation groups , Cuanzhu ( BL 2 ) , Yuyao ( EX-HN 4 ) , Sizhukong ( TE 23 ) , Taiyang ( EX-HN 5 ) , Fengchi ( GB 20 ) , Zusanli ( ST 36 ) , Guangming ( GB 37 ) and Sanyinjiao ( SP 6 ) were punctured , but stimulated with rotating manipulation and lifting-thrusting manipulation respectively three times per week , 10 times as a treatment session and totally one session was required .
METHODS	In the corrective lenses group , the glasses were applied at daytime .
METHODS	The clinical efficacy and the changes in distant vision of naked eye before and after treatment were compared among the three groups .
RESULTS	The total effective rate was 87.5 % ( 105/120 ) in the rotating manipulation group , which was better than 69.2 % ( 83/120 ) in the lifting-thrusting manipulation group ( P < 0.05 ) .
RESULTS	The distant vision of naked eye was improved apparently in the rotating manipulation group and the lifting-thrusting manipulation group after treatment ( both P < 0.05 ) .
RESULTS	But it was not improved in the corrective lenses group ( P > 0.05 ) .
RESULTS	The distant vision of naked eye was improved more apparently after treatment in the rotating manipulation group as compared with that in the lifting-thrusting manipulation group ( 0.75 + / - 0.23 vs 0.68 + / - 0.24 , P < 0.05 ) .
RESULTS	For 96 cases ( 192 eyes ) with acupuncture treatment , in 3-month follow-up , 87.0 % ( 167/192 ) of the cases maintained the stable vision as the original level and 13.0 % ( 25/192 ) of them were reduced in the vision In the acupuncture groups , it was found that the improvement of distant vision of naked eye was more obvious after treatment with younger age , better basic vision and shorter duration of sickness ( all P < 0.05 ) .
CONCLUSIONS	Acupuncture achieves the positive and sustainable clinical effect on juvenile myopia , and the results of rotating manipulation are superior to that of lifting-thrusting manipulation .
CONCLUSIONS	Age , basic vision and duration of sickness impact the clinical efficacy .

###25255587
OBJECTIVE	To evaluate the efficacy of pomegranate juice supplementation on matrix metalloproteinases2 and 9 serum levels and improving antioxidant function in young healthy males during exhaustive exercise .
METHODS	The study was conducted at Ardabil University of Medical Sciences , Iran , in 2010-11 and comprised 28 healthy subjects in 18-24 age bracket .
METHODS	They were randomly divided into control and supplemented groups .
METHODS	One cup of pomegranate juice and one cup of tap water were given to supplemented and control groups daily for two weeks respectively .
METHODS	Fasting blood samples were taken at baseline and at the end of two weeks of intervention .
METHODS	The subjects were given one exhaustive exercise and then fasting blood samples were taken for testing blood glutathione peroxidase and superoxide dismutase and serum levels of high sensitivity C-reactive protein , zinc , ceruloplasmin , matrix metalloproteinases 2 and 9 , malondialdehyde and total antioxidant capacity .
METHODS	Data was analysed using descriptive statistical tests , paired and independent sample t-test .
RESULTS	The blood levels of glutathione peroxidase and superoxide dismutase and serum levels of total antioxidant capacity after exhaustive exercise in the supplemented group were significantly increased ( p < 0.05 ) , while the content of matrix metalloproteinases 2 and 9 , ceruloplasmin and malondialdehyde showed a significant decrease in comparison to the control group ( p < 0.05 ) .
RESULTS	Besides , there were no significant changes in other biochemical factors .
CONCLUSIONS	Regular intake of pomegranate juice significantly modulates matrix metalloproteinases 2 and 9and serum levels of some inflammatory factors and thus protects against exhaustive exercise-induced oxidative injury in young healthy males .

###24430578
OBJECTIVE	Chronic postoperative pain is probably the most significant complication of tension-free inguinal hernia repair as its presence can considerably affect the life quality of the patient .
OBJECTIVE	Different mesh materials and different surgical techniques for mesh fixation have been applied to reduce chronic postoperative pain , with controversial , nevertheless , results .
OBJECTIVE	The aim of this prospective randomized study was to evaluate the effect of a relatively new mesh with self-fixating properties , used to repair inguinal hernia with the Lichtenstein technique , on early and chronic postoperative pain .
METHODS	Between June 2009 and June 2010 , 50 patients with primary unilateral inguinal hernia were treated using the Lichtenstein technique .
METHODS	Patients were randomly assigned to receive either a polypropylene mesh , fixed with polypropylene sutures ( n = 25 ; group A ) , or a self-fixating polypropylene mesh with resorbable polylactic acid microgrips ( n = 25 ; group B ) .
METHODS	Demographic data were recorded .
METHODS	Early and chronic postoperative pain was evaluated using the visual analog scale ( VAS ) .
METHODS	Duration of surgery , complications , length of hospitalization and recurrence were also recorded .
RESULTS	No statistical difference was found between the two groups in association to demographic data .
RESULTS	Operating time was 53.4 12.5 and 44.4 7.2 min in groups A and B , respectively , and the difference was statistically significant ( p < 0.001 ) .
RESULTS	No difference was observed between the groups regarding the postoperative complications .
RESULTS	The VAS of early postoperative pain was 1.7 1.9 in group A and 1.3 1.6 in group B , with the difference being not statistically significant ( p = 0.21 ) .
RESULTS	Concerning chronic pain , no remarkable statistically significant difference was observed between the two groups at 3-month , 1 - and 2-year follow-up period .
RESULTS	At the end of the study , no recurrence was reported in either group .
CONCLUSIONS	Self-fixating mesh can be safely and effectively used in inguinal hernia repair with the additional advantage of reducing the operative time compared to the classic Lichtenstein technique .
CONCLUSIONS	However , its use is not accompanied by reduced rates in early or chronic postoperative pain .

###24887239
BACKGROUND	It has been shown that nasal saline irrigation ( NSI ) alone can be effective in children with infectious and/or allergic respiratory problems , but no study has assessed the awareness or clinical use of NSI among practising pediatricians .
BACKGROUND	The main aim of this study was to evaluate the use of NSI in pre-school children by primary care pediatricians working in northern Italy .
METHODS	Nine hundred randomly selected National Health Service primary care pediatricians with an e-mail address were sent an e-mail asking whether they were willing to respond to a questionnaire regarding the use of NSI .
METHODS	The 870 who answered positively were sent an anonymous questionnaire by post and e-mail that had 17 multiple-choice items .
RESULTS	Completed questionnaires were received from 860 of the 870 primary care pediatricians ( 98.8 % ) .
RESULTS	NSI was used by almost all the respondents ( 99.3 % ) , although with significant differences in frequency .
RESULTS	It was considered both a prophylactic and a therapeutic measure by most of the respondents ( 60.3 % ) , who prescribed it every day for healthy children and more frequently when they were ill .
RESULTS	Most of the primary care pediatricians ( 87 % ) indicated an isotonic solution as the preferred solution , and the most frequently recommended administration devices were a nasal spray ( 67.7 % ) and bulb syringe ( 20.6 % ) .
RESULTS	Most of the pediatricians ( 75.6 % ) convinced parents to use NSI by explaining it could have various beneficial effects , and two-thirds ( 527/854 ; 61.7 % ) thought that most of the parents agreed about the importance of NSI .
RESULTS	Analysis of possible associations between NSI prescribing behaviour and the demographic data revealed an associations with age and gender , with pediatricians aged < 50 years prescribing NSI more frequently than their older counterparts ( p < 0.01 ) , and females prescribing NSI more frequently than males ( p < 0.01 ) .
CONCLUSIONS	In Northern Italy , most primary care pediatricians prescribe NSI for both the prophylaxis and therapy of upper respiratory tract problems in pre-school children .
CONCLUSIONS	However , many aspects of the procedure are not clarified , and this reduces parental compliance .
CONCLUSIONS	Given the medical and economic advantages of NSI , this situation should be changed as soon as possible .

###24360138
OBJECTIVE	To determine whether the use and adjustment of antidepressant pharmacotherapy accounted for the beneficial effects of collaborative care treatment on the improvement of mood symptoms and health-related quality of life ( HRQoL ) after coronary artery bypass graft ( CABG ) surgery .
METHODS	In a post-hoc analysis of data from the Bypassing the Blues ( BtB ) trial we tested the impact of antidepressant medication on changes in depression and HRQoL from the early postoperative period to 8-month follow-up .
METHODS	Two hundred fifty-nine depressed post-CABG patients scoring 10 on the Patient Health Questionnaire-9 were classified in four groups according to whether or not they received antidepressants at baseline and 8-months following randomization .
RESULTS	Patients using antidepressant pharmacotherapy at baseline and follow-up tended to be younger and female ( p0 .01 ) , but were similar in various clinical characteristics .
RESULTS	Just 24 % ( 63/259 ) of patients were on an antidepressant at baseline which increased to 36 % at follow-up ( 94/259 ) .
RESULTS	Compared to other groups , patients on antidepressants at both baseline and follow-up assessment showed the smallest improvement in mood symptoms and HRQoL .
RESULTS	While multivariate analyses confirmed that randomization to collaborative care was associated with greater improvement in mood symptoms ( odds ratio [ OR ] = 3.1 ; 95 % - confidence interval [ CI ] = 1.8-5 .4 , p < 0.0001 ) and mental HRQoL ( OR = 3.6 , CI = 1.4-9 .3 , p = 0.01 ) , use of antidepressant medication had no differential impact on either measure ( p = 0.06 and p = 0.92 , respectively ) .
CONCLUSIONS	The beneficial effects of collaborative care for post-CABG depression were not generated by adjustments in antidepressant medication .
BACKGROUND	Clinicaltrials.gov Identifier : NCT00091962 .
BACKGROUND	( http://clinicaltrials.gov/ct2/show/NCT00091962?term=rollman+cabg&rank=1 ) .

###25457928
OBJECTIVE	Many adolescents with obsessive-compulsive disorder ( OCD ) do not have access to evidence-based treatment .
OBJECTIVE	A randomized controlled non-inferiority trial was conducted in a specialist OCD clinic to evaluate the effectiveness of telephone cognitive-behavioral therapy ( TCBT ) for adolescents with OCD compared to standard clinic-based , face-to-face CBT .
METHODS	Seventy-two adolescents , aged 11 through 18 years with primary OCD , and their parents were randomized to receive specialist TCBT or CBT .
METHODS	The intervention provided differed only in the method of treatment delivery .
METHODS	All participants received up to 14 sessions of CBT , incorporating exposure with response prevention ( E/RP ) , provided by experienced therapists .
METHODS	The primary outcome measure was the Children 's Yale-Brown Obsessive-Compulsive Scale ( CY-BOCS ) .
METHODS	Blind assessor ratings were obtained at midtreatment , posttreatment , 3-month , 6-month , and 12-month follow-up .
RESULTS	Intent-to-treat analyses indicated that TCBT was not inferior to face-to-face CBT at posttreatment , 3-month , and 6-month follow-up .
RESULTS	At 12-month follow-up , there were no significant between-group differences on the CY-BOCS , but the confidence intervals exceeded the non-inferiority threshold .
RESULTS	All secondary measures confirmed non-inferiority at all assessment points .
RESULTS	Improvements made during treatment were maintained through to 12-month follow-up .
RESULTS	Participants in each condition reported high levels of satisfaction with the intervention received .
CONCLUSIONS	TCBT is an effective treatment and is not inferior to standard clinic-based CBT , at least in themidterm .
CONCLUSIONS	This approach provides a means of making a specialized treatment more accessible to many adolescents with OCD .
CONCLUSIONS	Clinical trial registration information-Evaluation of telephone-administered cognitive-behaviour therapy ( CBT ) for young people with obsessive-compulsive disorder ( OCD ) ; http://www.controlled-trials.com; ISRCTN27070832 .

###24281276
BACKGROUND	Many cannabinoid medications are approved in North America or in phase III trials , such as dronabinol , nabilone , or nabiximols .
BACKGROUND	Little is known about their subjective psychoactive effects when used for pain management .
BACKGROUND	We hypothesized that when used for pain , dronabinol has psychoactive effects in a dose-response relationship , whose peak effects are comparable with smoking marijuana .
METHODS	This was a randomized controlled trial of single dose placebo , 10 or 20 mg dronabinol in 30 chronic noncancer pain patients taking opioids and not using marijuana .
METHODS	Participants completed the Addiction Research Center Inventory ( ARCI ) hourly for 8 hours during 3 monitored sessions .
METHODS	Comparison sample was the ARCI ratings in participants with no pain ( N = 20 ) , monitored every 30 minutes after smoking a 1.99 % THC ( low ) and a 3.51 % ( high strength ) marijuana cigarette .
RESULTS	The 10 and 20 mg dronabinol doses had significantly elevated scores over time on 4/5 subscales versus placebo ( P < 0.05 ) .
RESULTS	Average daily morphine use , total pain relief ( TOTPAR ) , age , sex , and baseline pain level were not significant covariates .
RESULTS	ARCI peak effects at 2 hours were similar to peak effects of smoked marijuana at 30 minutes ( P = 0.80 , 10 mg = low strength , 20 mg = high strength ) .
CONCLUSIONS	In pain patients , oral dronabinol has similar psychoactive effects to smoking marijuana .
CONCLUSIONS	This risk must be considered in any decision to prescribe cannabinoid medications for pain .

###24676964
BACKGROUND	Self-harm is a major risk factor for completed suicide .
OBJECTIVE	To determine the efficacy of a brief psychological intervention - culturally adapted manual-assisted problem-solving training ( C-MAP ) - delivered following an episode of self-harm compared with treatment as usual ( TAU ) .
METHODS	The study was a randomised controlled assessor-masked clinical trial ( trial registration : ClinicalTrials.gov NCT01308151 ) .
METHODS	All patients admitted after an episode of self-harm during the previous 7 days to the participating medical units of three university hospitals in Karachi , Pakistan , were included in the study .
METHODS	A total of 250 patients were screened and 221 were randomly allocated to C-MAP plus treatment as usual ( TAU ) or to TAU alone .
METHODS	All patients were assessed at baseline , at 3 months ( end of intervention ) and at 6 months after baseline .
METHODS	The primary outcome measure was reduction in suicidal ideation at 3 months .
METHODS	The secondary outcome measures included hopelessness , depression , coping resources and healthcare utilisation .
RESULTS	A total of 108 patients were randomised to the C-MAP group and 113 to the TAU group .
RESULTS	Patients in the C-MAP group showed statistically significant improvement on the Beck Scale for Suicide Ideation and Beck Hopelessness Inventory , which was sustained at 3 months after the completion of C-MAP .
RESULTS	There was also a significant reduction in symptoms of depression compared with patients receiving TAU .
CONCLUSIONS	The positive outcomes of this brief psychological intervention in patients attempting self-harm are promising and suggest that C-MAP may have a role in suicide prevention .

###24807502
OBJECTIVE	Bladder pain syndrome/interstitial cystitis ( BPS/IC ) is a chronic disease that highly degrades the quality of life for patients .
OBJECTIVE	In the present study , Internet intervention was used to care for bladder pain syndrome/interstitial cystitis patients to alleviate their pain and bothering symptoms .
METHODS	Healthcare education was carried out through the Internet by asking the patients , who were randomly divided into study ( 40 patients ) and control ( 40 patients ) groups , to check possible sensitive foods , habits , and behaviors weekly to remind and consolidate important rules for promoting quality of life .
METHODS	The symptom flares consultation through short message service with the Internet used to elevate healthcare efficiency was undertaken .
METHODS	Questionnaires , including Short Form 36 health survey , O'Leary-Sant symptom and problem indices , as well as visual analog scales pain and urgency scales , were used to evaluate quality of life and disease severity improvements before and after information and communication technology intervention .
METHODS	The outcome was evaluated at week 8 .
RESULTS	The quality of life of both the control and study groups was significantly improved .
RESULTS	The quality of life and visual analog scales for the patients in the study group with information and communication technology intervention showed a much greater improvement compared with the patients in the control group ( P < 0.05 ) .
CONCLUSIONS	The E-health system was shown to be effective in improving quality of life of bladder pain syndrome/interstitial cystitis patients through intervention of Internet healthcare education and short message service for the consolidation of healthy behavior and lifestyle in the 8-week follow up .

###26271059
BACKGROUND	Bleeding limits anticoagulant treatment in patients with acute coronary syndromes ( ACS ) .
OBJECTIVE	We investigated whether background concomitant antiplatelet therapy influences the effects of apixaban after ACS .
METHODS	This study examined high-risk ACS patients who were treated with aspirin or aspirin plus clopidogrel and who were randomized to apixaban 5 mg twice daily or placebo .
METHODS	In a post-hoc analysis , we assessed whether the effect of apixaban on efficacy and safety outcomes varied by the concomitant antiplatelet regimen by using simple Cox modeling and marginal structural models with propensity scores and antiplatelet therapy as a time-dependent covariate .
RESULTS	At baseline , of 7,364 patients , 16.3 % ( n = 1,202 ) were on aspirin alone , and 79.0 % ( n = 5,814 ) were on aspirin plus clopidogrel .
RESULTS	A total of 19.2 % ( n = 1,415 ) switched antiplatelet therapy during follow-up .
RESULTS	No differential effect of apixaban versus placebo was observed for the composite endpoint of cardiovascular death , myocardial infarction , and ischemic stroke in patients taking aspirin ( 12.21 per 100 patient-years vs. 13.21 per 100 patient-years ; adjusted hazard ratio [ HR ] : 0.91 ; 95 % confidence interval [ CI ] : 0.62 to 1.32 ) or aspirin plus clopidogrel ( 13.22 vs. 14.24 ; adjusted HR : 0.95 ; 95 % CI : 0.78 to 1.14 ; p ( interaction ) = 0.84 ) .
RESULTS	Compared with placebo , apixaban increased Thrombolysis In Myocardial Infarction major bleeding in patients taking aspirin ( 1.48 vs. 0.25 ; adjusted HR : 6.62 ; 95 % CI : 0.75 to 51.73 ) and in patients taking aspirin plus clopidogrel ( 2.58 vs. 1.02 ; adjusted HR : 2.44 ; 95 % CI : 1.34 to 4.45 ; p ( interaction ) = 0.41 ) .
RESULTS	Similar results were obtained with marginal structural models and in patients treated with and without percutaneous coronary intervention .
CONCLUSIONS	Post-ACS treatment with apixaban versus placebo showed no efficacy , but it increased bleeding regardless of concomitant therapy with aspirin alone or aspirin plus clopidogrel .
CONCLUSIONS	( Apixaban for Prevention of Acute Ischemic Events 2 [ APPRAISE-2 ] ; NCT00831441 ) .

###24504431
OBJECTIVE	Cold water immersion ( CWI ) may be beneficial for acute recovery from exercise , but it may impair long-term performance by attenuating the stimuli responsible for adaptation to training .
OBJECTIVE	We compared effects of CWI and passive rest on cycling performance during a simulated cycling grand tour .
METHODS	Thirty-four male endurance-trained competitive cyclists were randomized to CWI for four times per week for 15 min at 15C or control ( passive recovery ) groups for 7 d of baseline training , 21 d of intensified training , and an 11-d taper .
METHODS	Criteria for completion of training and testing were satisfied by 10 cyclists in the CWI group ( maximal aerobic power , 5.13 0.21 Wkg ; mean SD ) and 11 in the control group ( 5.01 0.41 Wkg ) .
METHODS	Each week , cyclists completed a high-intensity interval cycling test and two 4-min bouts separated by 30 min .
METHODS	CWI was performed four times per week for 15 min at 15C .
RESULTS	Between baseline and taper , cyclists in the CWI group had an unclear change in overall 4-min power relative to control ( 2.7 % 5.7 % ) , although mean power in the second effort relative to the first was likely higher for the CWI group relative to control ( 3.0 % 3.8 % ) .
RESULTS	The change in 1-s maximum mean sprint power in the CWI group was likely beneficial compared with control ( 4.4 % 4.2 % ) .
RESULTS	Differences between groups for the 10-min time trial were unclear ( -0.4 % 4.3 % ) .
CONCLUSIONS	Although some effects of CWI on performance were unclear , data from this study do not support recent speculation that CWI is detrimental to performance after increased training load in competitive cyclists .

###24678572
OBJECTIVE	While self-report methods to collect exposure information have large practical advantages in many research contexts , little research has specifically investigated the reliability and validity of motorcyclists ' self-reported exposure .
OBJECTIVE	The present study aimed to examine the reliability and validity of different self-report exposure measures and to provide recommendations on best practice self-report riding exposure questions .
METHODS	The reliability and validity of different self-report exposure measures were examined amongst novice motorcyclists through t-tests , Bland Altman plots , coefficients of variation , and correlations .
RESULTS	The most valid and reliable data was provided when riding exposure was asked for the current average week rather than earlier and longer periods , and in units of time rather than distance or number of trips .
RESULTS	The greater reliability of riding exposure found amongst commuting and rural riders compared to recreational and metropolitan riders respectively and at the second interview compared to the first suggests that factors such as riding purposes , geographical locations , and riding experience can contribute to measurement error .
CONCLUSIONS	If self-reported odometer readings are used , questions on whether the respondents share their own bike or ride more than one bike , and a built-in process to ensure respondents report the exact odometer reading on their bike are recommended .
CONCLUSIONS	It is recommended that self-report riding exposure questions ask about the hours of riding for the current average week , and data on riding purposes , locations , and experience are also collected .

###24782192
OBJECTIVE	To determine whether gene expression profiles identified in peripheral whole blood samples could be used to determine therapeutic outcome in a cohort of children with newly diagnosed polyarticular juvenile idiopathic arthritis ( JIA ) .
METHODS	Whole blood samples from the Trial of Early Aggressive Therapy ( TREAT ) in JIA patients were analyzed on Illumina microarrays , and differential gene expression was compared to expression in healthy controls .
METHODS	Microarray results were validated by real-time quantitative polymerase chain reaction in an independent cohort of samples .
METHODS	Pathway analysis software was used to characterize gene expression profiles .
METHODS	Support vector machines were used to develop predictive models for different patient classes .
RESULTS	Differential gene expression profiles for rheumatoid factor ( RF ) - positive and RF-negative patients were remarkably similar .
RESULTS	Pathway analysis revealed a broad range of affected pathways , consistent with current mechanistic theories .
RESULTS	Modeling showed that the prognosis at 6 months was strongly linked to gene expression at presentation , irrespective of treatment .
CONCLUSIONS	Gene expression is linked to therapeutic outcome , and gene expression in the peripheral blood may be a suitable target for a prognostic test .

###25092686
OBJECTIVE	To examine counterregulatory glucose kinetics and test the hypothesis that - adrenergic blockade impairs these in patients with type 2 diabetes mellitus ( T2DM ) and advanced - failure .
METHODS	Nine insulin-requiring T2DM subjects and six matched nondiabetic control subjects were studied .
METHODS	- Cell function was assessed by the C-peptide response to arginine stimulation .
METHODS	Counterregulatory hormonal responses and glucose kinetics were assessed by hyperinsulinemic euglycemic-hypoglycemic clamps with [ 3 - ( 3 ) H ] glucose infusion .
METHODS	T2DM subjects underwent two clamp experiments in a randomized crossover fashion : once with infusion of the - adrenergic antagonist propranolol and once with infusion of normal saline .
RESULTS	Compared with the control subjects , T2DM subjects had threefold reduced C-peptide responses to arginine stimulation .
RESULTS	During the hypoglycemic clamp , glucagon responses were markedly diminished ( 16.0 4.2 vs. 48.6 6.0 ng/L , P < 0.05 ) , but other hormonal responses and the decrement in the required exogenous glucose infusion rate ( GIR ) from the euglycemic clamp were normal ( -10.4 1.1 vs. -7.8 1.9 mol kg ( -1 ) min ( -1 ) in control subjects ) ; however , endogenous glucose production ( EGP ) did not increase ( -0.8 1.0 vs. 2.2 0.7 mol kg ( -1 ) min ( -1 ) in control subjects , P < 0.05 ) , whereas systemic glucose disposal decreased normally .
RESULTS	- Adrenergic blockade in the T2DM subjects increased GIR 20 % during the euglycemic clamp ( P < 0.01 ) , but neither increased GIR during the hypoglycemic clamp or decreased its decrement from the euglycemic clamp to the hypoglycemic clamp .
CONCLUSIONS	Overall glucose counterregulation is preserved in advanced T2DM , but the contribution of EGP is diminished .
CONCLUSIONS	- Adrenergic blockade may increase insulin sensitivity at normoglycemia but does not impair glucose counterregulation in T2DM patients , even those with advanced - cell failure .

###24909532
BACKGROUND	Medical simulation training requires effective and efficient training strategies .
BACKGROUND	Dyad practice may be a training strategy worth pursuing because it has been proven effective and efficient in motor skills learning .
BACKGROUND	In dyad practice two participants collaborate in learning a task they will eventually perform individually .
BACKGROUND	In order to explore the effects of dyad practice in a medical simulation setting , this study examined the effectiveness and efficiency of dyad practice compared with individual practice in the learning of bronchoscopy through simulation-based training .
METHODS	A total of 36 students of medicine were randomly assigned to either individual practice or dyad practice .
METHODS	The training setting included video-based instruction , 10 bronchoscopy simulator cases and instructor feedback .
METHODS	Participants in the dyad practice group alternated between physical and observational practice and hence physically undertook only half of the training cases undertaken by participants who practised individually .
METHODS	Pre - , post - and delayed ( 3weeks ) retention tests were used to assess skills according to previously validated simulator measures .
METHODS	Data were analysed using repeated-measures analysis of variance ( anova ) on each dependent measure .
RESULTS	A significant main effect of test was found for all measures ( F2 ,67 > 23.32 , p < 0.001 ) , indicating improvement in performance from pre-tests to post-tests and retention tests .
RESULTS	No interaction was found between test and group ( F2 ,67 < 0.26 , p > 0.49 ) , indicating parallel learning curves .
RESULTS	Most importantly , no main effect of group was found for any of the measures , indicating no difference between learning curves ( F1 ,34 = 2.08 , p < 0.16 ) .
CONCLUSIONS	Individual practice and dyad practice did not differ in their effectiveness for the acquisition of bronchoscopy skills through supervised simulation training .
CONCLUSIONS	However , dyad practice proved more efficient than individual practice because two participants practising in dyads learned as much as one participant practising individually but required the same instructor resources and training time as the single learner .

###24698485
BACKGROUND	Dolutegravir has been shown to be non-inferior to an integrase inhibitor and superior to a non-nucleoside reverse transcriptase inhibitor ( NNRTI ) .
BACKGROUND	In FLAMINGO , we compared dolutegravir with darunavir plus ritonavir in individuals naive for antiretroviral therapy .
METHODS	In this multicentre , open-label , phase 3b , non-inferiority study , HIV-1-infected antiretroviral therapy-naive adults with HIV-1 RNA concentration of 1000 copies per mL or more and no resistance at screening were randomly assigned ( 1:1 ) to receive either dolutegravir 50 mg once daily or darunavir 800 mg plus ritonavir 100 mg once daily , with investigator-selected tenofovir-emtricitabine or abacavir-lamivudine .
METHODS	Randomisation was stratified by screening HIV-1 RNA ( 100,000 or > 100,000 copies per mL ) and nucleoside reverse transcriptase inhibitor ( NRTI ) selection .
METHODS	The primary endpoint was the proportion of patients with HIV-1 RNA concentration lower than 50 copies per mL ( Food and Drug Administration [ FDA ] snapshot algorithm ) at week 48 with a 12 % non-inferiority margin .
METHODS	This trial is registered with ClinicalTrials.gov , NCT01449929 .
RESULTS	Recruitment began on Oct 31 , 2011 , and was completed on May 24 , 2012 , in 64 research centres in nine countries worldwide .
RESULTS	Of 595 patients screened , 484 patients were included in the analysis ( 242 in each group ) .
RESULTS	At week 48 , 217 ( 90 % ) patients receiving dolutegravir and 200 ( 83 % ) patients receiving darunavir plus ritonavir had HIV-1 RNA of less than 50 copies per mL ( adjusted difference 71 % , 95 % CI 09-132 ) , non-inferiority and on pre-specified secondary analysis dolutegravir was superior ( p = 0025 ) .
RESULTS	Confirmed virological failure occurred in two ( < 1 % ) patients in each group ; we recorded no treatment-emergent resistance in either group .
RESULTS	Discontinuation due to adverse events or stopping criteria was less frequent for dolutegravir ( four [ 2 % ] patients ) than for darunavir plus ritonavir ( ten [ 4 % ] patients ) and contributed to the difference in response rates .
RESULTS	The most commonly reported ( 10 % ) adverse events were diarrhoea ( dolutegravir 41 [ 17 % ] patients vs darunavir plus ritonavir 70 [ 29 % ] patients ) , nausea ( 39 [ 16 % ] vs 43 [ 18 % ] ) , and headache ( 37 [ 15 % ] vs 24 [ 10 % ] ) .
RESULTS	Patients receiving dolutegravir had significantly fewer low-density lipoprotein values of grade 2 or higher ( 11 [ 2 % ] vs 36 [ 7 % ] ; p = 00001 ) .
CONCLUSIONS	Once-daily dolutegravir was superior to once-daily darunavir plus ritonavir .
CONCLUSIONS	Once-daily dolutegravir in combination with fixed-dose NRTIs represents an effective new treatment option for HIV-1-infected , treatment-naive patients .
BACKGROUND	ViiV Healthcare and Shionogi & Co. .

###25482466
BACKGROUND	Nerve-preserving surgery has been provided for patients with rectal cancer ; however , sexual dysfunction remains a common complication of rectal cancer surgery .
BACKGROUND	This study explored the efficacy of udenafil to treat erectile dysfunction in male patients who underwent total mesorectal excision ( TME ) for rectal cancer .
METHODS	We conducted a randomized , double-blind , placebo-controlled clinical trial involving 80 male patients who had decreased International Index of Erectile Function-5 ( IIEF-5 ) scores after TME for rectal cancer .
METHODS	Patients received placebo ( 50 mg ) or udenafil ( 50 mg ) for 12 weeks .
METHODS	The primary outcome variable was the change in IIEF-5 scores .
METHODS	The secondary outcome variables were Sexual Encounter Profile ( SEP ) questions 2 ( Q2 ) and 3 ( Q3 ) , and the Global Assessment Question ( GAQ ) .
RESULTS	Baseline IIEF-5 scores , SEP Q2 and Q3 responses , and spontaneous erection rates were consistent in both groups .
RESULTS	At the end of treatment , the change in IIEF-5 scores from the baseline was significantly higher in the udenafil group than it was in the placebo group ( mean IIEF-5 score , 4.8 4.0 vs 2.0 1.7 ; P < .05 ) .
RESULTS	Responses to SEP Q2 , SEP Q3 , and GAQ were significantly higher in the udenafil group than they were in the placebo group ( SEP Q2 , P = .025 ; SEP Q3 , P = .044 ; GAQ , P < .001 ) .
RESULTS	Treatment-related adverse events ( n = 4 ) were all mild in severity .
CONCLUSIONS	Oral udenafil was deemed safe and effective for the treatment of erectile dysfunction in patients who underwent TME for rectal cancer .

###24685737
BACKGROUND	The aim of this study was to compare the effect of continuous care model with routine care on the quality of life among patients who receive a kidney transplant .
METHODS	In a randomized clinical trial , 90 kidney transplant patients were selected from 4 hospitals in Tehran , Iran , and were randomly assigned to 2 group .
METHODS	In the experimental group , continuous care model was applied for 3 months and the control group received routine care .
METHODS	The scale scores of the Kidney Transplant Questionnaire concerning quality of life were monthly compared between the two groups .
RESULTS	Of 90 patients , 4 in the experimental and 8 in the control group were excluded from the study .
RESULTS	Final analysis was performed on 41 in the experimental and 37 in the control groups .
RESULTS	No significant difference was found between the two groups in terms of demographic variables .
RESULTS	Although the quality of life scores increased in both groups , the mean scores of the experimental group were significantly higher than those in the control group at 1 , 2 , and 3 months .
CONCLUSIONS	Continuous care model may improve the kidney transplant patients ' quality of life .

###24485665
BACKGROUND	Hilar cholangiocarcinoma is an uncommon cancer and its overall incidence is increasing .
BACKGROUND	Photodynamic therapy ( PDT ) has been proposed as palliative management for unresectable hilar cholangiocarcinoma ( UHC ) .
BACKGROUND	To date , little is known about the role of the addition of systemic chemotherapy to PDT for UHC .
BACKGROUND	We performed a prospective , randomised , phase II trial to compare PDT plus S-1 and PDT alone for UHC .
METHODS	Patients with UHC were randomly assigned ( in a 1:1 ratio ) to PDT plus S-1 or PDT alone .
METHODS	The primary end-point was overall survival .
METHODS	The secondary end-points were progression-free survival , complications , re-intervention rate and quality of life .
METHODS	This trial is registered with clinicalTrials.gov , number NCT00869635 .
RESULTS	Between February 2009 and May 2012 , we randomly assigned 21 patients to receive PDT plus S-1 and 22 to receive PDT alone .
RESULTS	The UHC patients treated with PDT plus S-1 showed higher 1-year survival rate compared with the patients treated with PDT alone ( 76.2 % versus 32 % , P = 0.003 ) and prolonged overall survival ( median 17 months , 95 % confidence interval [ CI ] : 12.6-21 .4 , versus 8 months , 95 % CI : 6-10 , P = 0.005 , hazard ratio [ HR ] , 0.36 ; 95 % CI : 0.17-0 .75 ) .
RESULTS	Regarding the secondary end-points , PDT plus S-1 was associated with prolonged progression-free survival compared with PDT alone ( median 10 months [ 95 % CI : 4.1-16 ] versus 2 months [ 95 % CI : 0.4-3 .5 ] , P = 0.009 ( HR for progression 0.39 , 95 % CI : 0.19-0 .83 ) .
RESULTS	There were no differences in the number of PDT sessions , the frequency of cholangitis , overall adverse events or the quality of life in either group .
CONCLUSIONS	PDT plus S-1 was well tolerated and was associated with a significant improvement of overall survival and progression-free survival compared with PDT alone in patients with UHC .
CONCLUSIONS	These findings warrant further clinical investigation of PDT plus S-1 in patients with UHC .

###25416486
BACKGROUND	Patient centred and individually-tailored counselling of older people with a chronic condition who live at home is a useful intervention to support their independence .
OBJECTIVE	The paper presents the development and psychometric testing of the APN-BQ Instrument , to measure patient-centeredness .
METHODS	To measure the quality of an in-home counselling intervention , a 23-item questionnaire was developed and tested with 206 people 80 years and older .
METHODS	Principal component analysis with Varimax Rotation was conducted ( n = 206 ) .
RESULTS	Analysis revealed a four factor ( fs = 0.91 ) model scoring in 19 items .
RESULTS	All factors loaded > 0.45 .
RESULTS	Cronbach 's alpha was 0.86 .
RESULTS	The utility and acceptance of the instrument was confirmed by the high response rate ( 100 % ) and the fact that participants answered 98.8 % of all questions .
CONCLUSIONS	The APN-BQ has shown to be a reliable Instrument with good content and construct validity .
CONCLUSIONS	It is a tool for APNs to measure structure , process , and outcome quality of a patient-centred and individually-tailored counselling program , including the degree of patient participation , and patient empowerment .

###25032771
OBJECTIVE	To compare the efficacy of two different techniques for vertical bone regeneration at implant placement with particulate autogenous bone at 6 years after loading by means of a double-blind , superiority , parallel-group randomized clinical trial .
METHODS	The study was conducted in a private center in Italy between April 2004 and December 2011 .
METHODS	Patients in whom vertical bone augmentation was indicated in combination with the placement of single or multiple implants were eligible for inclusion in this trial .
METHODS	Patients were randomized to receive either resorbable collagen barriers supported by an osteosynthesis plate ( test group ) or nonresorbable titanium-reinforced expanded polytetrafluoroethylene barriers ( control group ) .
METHODS	The outcome variables-radiographic bone variation at implant sites , implant failures , and complications - were evaluated 6 years after loading .
METHODS	Randomization was done by computer , with allocation concealed by opaque sequentially numbered sealed envelopes .
METHODS	The patients and the radiographic examiner were blinded to group assignment .
RESULTS	Twenty-two patients were randomized : 11 to the resorbable barrier group and 11 to the nonresorbable ( control ) group .
RESULTS	One control group patient dropped out .
RESULTS	The mean bone level 6 years after surgery was 1.33 mm for the resorbable group and 1.00 mm for the nonresorbable group .
RESULTS	The adjusted difference in bone changes between groups was 0.15 mm ( 95 % confidence interval , -0.39 to 0.69 , P = .5713 ) .
RESULTS	No implant failures or complications occurred after loading .
CONCLUSIONS	No differences were observed in this comparison of resorbable and nonresorbable barriers with simultaneous implant placement for vertical ridge augmentation .

###24331154
BACKGROUND	Effective maintenance therapies after chemoradiotherapy for lung cancer are lacking .
BACKGROUND	Our aim was to investigate whether the MUC1 antigen-specific cancer immunotherapy tecemotide improves survival in patients with stage III unresectable non-small-cell lung cancer when given as maintenance therapy after chemoradiation .
METHODS	The phase 3 START trial was an international , randomised , double-blind trial that recruited patients with unresectable stage III non-small-cell lung cancer who had completed chemoradiotherapy within the 4-12 week window before randomisation and received confirmation of stable disease or objective response .
METHODS	Patients were stratified by stage ( IIIA vs IIIB ) , response to chemoradiotherapy ( stable disease vs objective response ) , delivery of chemoradiotherapy ( concurrent vs sequential ) , and region using block randomisation , and were randomly assigned ( 2:1 , double-blind ) by a central interactive voice randomisation system to either tecemotide or placebo .
METHODS	Injections of tecemotide ( 806 g lipopeptide ) or placebo were given every week for 8 weeks , and then every 6 weeks until disease progression or withdrawal .
METHODS	Cyclophosphamide 300 mg/m ( 2 ) ( before tecemotide ) or saline ( before placebo ) was given once before the first study drug administration .
METHODS	The primary endpoint was overall survival in a modified intention-to-treat population .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00409188 .
RESULTS	From Feb 22 , 2007 , to Nov 15 , 2011 , 1513 patients were randomly assigned ( 1006 to tecemotide and 507 to placebo ) .
RESULTS	274 patients were excluded from the primary analysis population as a result of a clinical hold , resulting in analysis of 829 patients in the tecemotide group and 410 in the placebo group in the modified intention-to-treat population .
RESULTS	Median overall survival was 25.6 months ( 95 % CI 22.5-29 .2 ) with tecemotide versus 22.3 months ( 19.6-25 .5 ) with placebo ( adjusted HR 0.88 , 0.75-1 .03 ; p = 0.123 ) .
RESULTS	In the patients who received previous concurrent chemoradiotherapy , median overall survival for the 538 ( 65 % ) of 829 patients assigned to tecemotide was 30.8 months ( 95 % CI 25.6-36 .8 ) compared with 20.6 months ( 17.4-23 .9 ) for the 268 ( 65 % ) of 410 patients assigned to placebo ( adjusted HR 0.78 , 0.64-0 .95 ; p = 0.016 ) .
RESULTS	In patients who received previous sequential chemoradiotherapy , overall survival did not differ between the 291 ( 35 % ) patients in the tecemotide group and the 142 ( 35 % ) patients in the placebo group ( 19.4 months [ 95 % CI 17.6-23 .1 ] vs 24.6 months [ 18.8-33 .0 ] , respectively ; adjusted HR 1.12 , 0.87-1 .44 ; p = 0.38 ) .
RESULTS	Grade 3-4 adverse events seen with a greater than 2 % frequency with tecemotide were dyspnoea ( 49 [ 5 % ] of 1024 patients in the tecemotide group vs 21 [ 4 % ] of 477 patients in the placebo group ) , metastases to central nervous system ( 29 [ 3 % ] vs 6 [ 1 % ] ) , and pneumonia ( 23 [ 2 % ] vs 12 [ 3 % ] ) .
RESULTS	Serious adverse events with a greater than 2 % frequency with tecemotide were pneumonia ( 30 [ 3 % ] in the tecemotide group vs 14 [ 3 % ] in the placebo group ) , dyspnoea ( 29 [ 3 % ] vs 13 [ 3 % ] ) , and metastases to central nervous system ( 32 [ 3 % ] vs 9 [ 2 % ] ) .
RESULTS	Serious immune-related adverse events did not differ between groups .
CONCLUSIONS	We found no significant difference in overall survival with the administration of tecemotide after chemoradiotherapy compared with placebo for all patients with unresectable stage III non-small-cell lung cancer .
CONCLUSIONS	However , tecemotide might have a role for patients who initially receive concurrent chemoradiotherapy , and further study in this population is warranted .
BACKGROUND	Merck KGaA ( Darmstadt , Germany ) .

###24783914
OBJECTIVE	To determine efficacy and safety of treatment with Rituximab and Etanercept plus Methotrexate in patients with active Rheumatoid Arthritis ( RA ) , who had an inadequate response to nonbiologic DMARDS therapies and to explore the pharmacogenetics and pharmacodynamics of Rituximab and Etanercept in our populations .
OBJECTIVE	Study was done at Rheumatology Clinic of University Clinical Centre in Prishtina during 2009-2011 years .
METHODS	We evaluated primary efficacy and safety at 24 weeks in patients enrolled in the study of long-term efficacy of Rituximab and Etanercept .
METHODS	Patients with active Rheumatoid Arthritis and an inadequate response to 1 or more non biologic DMARDS were randomized to receive intravenous Rituximab ( 1 course consisting of 2 infusions of 1.000 mg each - one group , and Etanercept 25 mg twice weekly - second group , but both groups with background MTX .
METHODS	The primary efficacy end point was a response on the ACR 20 % , improvement criteria at 24 weeks , Secondary end points were responses on the ACR 50 and ACR 70 , improvement criteria , the DAS 28 , and EULAR response criteria at 24 weeks .
RESULTS	During our investigations we treated 20 patients , 15 females and 5 males , in the treated group with RTX and 13 patients 8 females and 5 males in the treated group with ETN .
RESULTS	Patients of group 1 and group 2 were of ages 37-69 years old and 19-69 years old ( average 47-44 ) Most of the patients belong in 2nd and 3rd functional stage according to Steinbrocker .
RESULTS	All ACR response parameters were significantly improved in RTX treated patients who also had clinically meaningful improvement in fatigue , disability and quality of life .
RESULTS	Patients showed a trend less progression in radiographic end points .
RESULTS	Most adverse events occurred with the first RTX infusion and were mild to moderate severity .
CONCLUSIONS	At 24 weeks , a single course of RTX and ETN provided significant and clinically meaningful improvements in disease activity in patients with active , longstanding RA who had an inadequate response to 1 or more nonbiologic DMARDS .

###25247319
BACKGROUND	Oesophageal squamous cell carcinoma ( ESCC ) is a fatal disease with 5-year survival rates of < 5 % in Northern Iran .
BACKGROUND	Oesophageal squamous dysplasia ( ESD ) is the precursor histologic lesion of ESCC .
BACKGROUND	This pilot study was conducted to assess the feasibility , safety , and acceptability of non-endoscopic cytological examination of the oesophagus and to provide initial data on the accuracy of cytological atypia for identifying patients with ESD in this very-high-risk area .
METHODS	Randomly selected asymptomatic participants of the Golestan Cohort Study were recruited .
METHODS	A cytological specimen was taken using a capsule sponge device and evaluated for atypical cells .
METHODS	Sections of the cytological specimen were also stained for p53 protein .
METHODS	Patient acceptability was assessed using a visual analogue scale .
METHODS	The cytological diagnosis was compared with a chromoendoscopic examination using Lugol 's solution .
RESULTS	Three hundred and forty-four subjects ( 43 % male , mean ( s.d. ) age 55.6 ( 7.9 ) years ) were referred to the study clinic .
RESULTS	Three hundred and twelve met eligibility criteria and consented , of which 301 subjects ( 96.5 % ) completed both cytological and endoscopic examinations .
RESULTS	There were no complications .
RESULTS	Most of the participants ( 279 ; 92.7 % ) were satisfied with the examination .
RESULTS	The sensitivity and specificity of the cytological examination for identifying subjects with high-grade ESD were 100 and 97 % , respectively .
RESULTS	We found an accuracy of 100 % ( 95 % CI = 99-100 % ) for a combination of cytological examination and p53 staining to detect high-grade ESD .
CONCLUSIONS	The capsule sponge methodology seems to be a feasible , safe , and acceptable method for diagnosing precancerous lesions of the oesophagus in this population , with promising initial accuracy data for the detection of high-grade ESD .

###26148362
OBJECTIVE	To study the possibility of desflurane use for induction of anesthesia .
METHODS	We analysed the intra - and immediate postoperative periods in 125 patients .
METHODS	Depending on the intended anesthesia method patients were randomised ( the method of the envelopes ) and included in one of two study groups : 1 -- volatile desflurane-based anesthesia ( n = 62 ) ; 2 -- volatile sevoflurane-based anesthesia ( n = 63 ) .
RESULTS	Desflurane based anesthesia led to apnea until the installation of laryngeal mask in 94.5 % of patients ( of 54 ) , for whom a completion of inhalation induction was possible , whereas sevoflurane based anesthesia.led to apnea occurred only in one patient ( 1.6 % ) .
CONCLUSIONS	`` Step up '' desflurane-based inhalational induction and sevoflurane-based maximum concentration inhalational induction `` without primaryfilling of the circuit '' showed no significant in time necessary for achieving an anesthetic concentration essential for LMA installation .
CONCLUSIONS	In both groups it was 3-5 min .
CONCLUSIONS	desflurane-based volatile induction with addition of fentanyl led to apnea in 97 % of patients and associates with a higher risk of bronchospasm .

###24482093
OBJECTIVE	Social psychological theories provide bases for understanding how social comparison processes may impact peer influence .
OBJECTIVE	This study examined two peer characteristics that may impact peer influence on adolescent girls ' weight-related behavior intentions : body size and popularity .
METHODS	A school-based sample of 66 9th grade girls ( 12-15 years old ) completed an experimental paradigm in which they believed they were interacting with other students ( i.e. , `` e-confederates '' ) .
METHODS	The body size and popularity of the e-confederates were experimentally manipulated .
METHODS	Participants were randomly assigned to one of the three experimental conditions in which they were exposed to identical maladaptive weight-related behavior norms communicated by ostensible female peers who were either : ( 1 ) Thin and Popular ; ( 2 ) Thin and Average Popularity ; or ( 3 ) Heavy and Average Popularity .
METHODS	Participants ' intent to engage in weight-related behaviors was measured pre-experiment and during public and private segments of the experiment .
RESULTS	A significant effect of condition on public conformity was observed .
RESULTS	Participants exposed to peers ' maladaptive weight-related behavior norms in the Heavy and Average condition reported significantly less intent to engage in weight-related behaviors than participants in either of the thin-peer conditions ( F ( 2 ) = 3.93 , p = .025 ) .
RESULTS	Peer influence on private acceptance of weight-related behavior intentions was similar across conditions ( F ( 2 ) = .47 , p = .63 ) .
CONCLUSIONS	Body size comparison may be the most salient component of peer influence processes on weight-related behaviors .
CONCLUSIONS	Peer influence on weight-related behavior intention also appears to impact private beliefs .
CONCLUSIONS	Considering peer norms in preventive interventions combined with dissonance-based approaches may be useful .

###24475840
OBJECTIVE	To compare the capability to aid prediction of clinical outcome measures , including progression-free survival ( PFS ) and overall survival ( OS ) , between volumetric estimates from contrast material-enhanced ( CE ) T1-weighted subtraction maps and traditional segmentation in a randomized multicenter clinical trial of recurrent glioblastoma ( GBM ) patients treated with bevacizumab .
METHODS	All patients participating in this study signed institutional review board-approved informed consent at their respective institutions prior to enrolling in the multicenter clinical trial .
METHODS	One-hundred sixty patients with recurrent GBM enrolled as part of a HIPAA-compliant , multicenter clinical trial ( AVF3708 g , BRAIN trial ) .
METHODS	Contrast-enhancing tumor volumes and change in volumes as a response to therapy were quantified by using either conventional segmentation or CE T1-weighted subtraction maps created by voxel-by-voxel subtraction of intensity-normalized nonenhanced T1-weighted images from CE T1-weighted images .
METHODS	These volumes were then tested as predictors of PFS and OS by using log-rank univariate analysis , the multivariate Cox proportional hazards regression model , and receiver operating characteristic analysis .
RESULTS	Use of CE T1-weighted subtraction maps qualitatively improved visualization and improved quantification of tumor volume after bevacizumab treatment .
RESULTS	Significant trends between the volume of tumor and change in tumor volume after therapy on CE T1-weighted subtraction maps were found for both PFS and OS ( pretreatment volume < 15 cm ( 3 ) , P < .003 ; posttreatment volume < 7.5 cm ( 3 ) , P < .05 ; percentage change in volume > 25 % , P = .004 for PFS and P = .053 for OS ) .
RESULTS	CE T1-weighted subtraction maps were significantly better at aiding prediction of 6-month PFS and 12-month OS compared with conventional segmentation by using receiver operating characteristic analysis ( P < .05 ) .
CONCLUSIONS	Use of CE T1-weighted subtraction maps improved visualization and aided better prediction of patient survival in recurrent GBM treated with bevacizumab compared with conventional segmentation of CE T1-weighted images .
CONCLUSIONS	Clinical trial registration no .
CONCLUSIONS	NCT00345163 .
CONCLUSIONS	Online supplemental material is available for this article .

###24272788
OBJECTIVE	The objective was to explore the role of specific patient-related and operator-related factors in pain perception during flexible laryngoscopy , which is one of the most common ENT procedures .
METHODS	Monocentric , randomized , individual prospective study .
METHODS	A total of 532 patients ( 145 men and 387 women ) , without any relevant ENT diseases , underwent laryngoscopy performed by otolaryngologists with various degrees of experience .
METHODS	Patient discomfort was reported using visual analog scores , and willingness to repeat the experience was also recorded .
RESULTS	Statistical analysis showed that greater pain was significantly associated with female patients and female otolaryngologists , whereas the pain was less severe in the cases of experienced laryngologists and older patients .
RESULTS	Pain plays an important role in determining the willingness to repeat the examination ; in fact , patients who experienced lower levels of pain during laryngoscopy were more prone to repeat the experience .
CONCLUSIONS	This article explores the importance of the extrinsic factors that are related to the patient and the otolaryngologist in determining the level of pain associated with laryngoscopy .
CONCLUSIONS	Our study indicated that laryngoscopy is generally a well-tolerated procedure , causing little overall discomfort , but that a subgroup of patients may experience more pain than others , which may affect the patient 's perspective toward undergoing a similar future experience .
CONCLUSIONS	Our analysis may be helpful for clinicians in understanding pain perception during a routine procedure , enabling them to focus more on that subgroup of patients who are more prone to pain .
METHODS	1b .

###25056584
BACKGROUND	The efficacy and safety of sublingual immunotherapy in house dust mite-induced asthma have yet to be firmly established .
BACKGROUND	We report the results of a double-blind , placebo-controlled , randomized clinical trial performed in mainland China .
METHODS	After a three-month baseline period , 484 asthmatic adults were randomized 2:1 to 12months of daily treatment with either an aqueous , standardized , 300 index of reactivity mixture of Dermatophagoides pteronyssinus and Dermatophagoides farinae extracts or a placebo .
METHODS	The primary efficacy criterion was well-controlled asthma for at least 16 of the last 20weeks of treatment .
RESULTS	In the active ( n = 308 ) and placebo ( n = 157 ) groups , well-controlled asthma was achieved by 85.4 % and 81.5 % of the patients , respectively ( P = 0.244 ) .
RESULTS	A subsequent post hoc analysis by asthma severity revealed significant clinical benefits in actively treated subjects with moderate , persistent asthma at baseline [ 401-800g budesonide/day ( n = 175 ) ] , with greater achievement of well-controlled asthma ( 80.5 % and 66.1 % for the active treatment and placebo groups , respectively ; P = 0.021 ) and totally controlled asthma ( 54.0 % and 33.9 % , respectively , P = 0.008 ) , a higher percentage of patients with an asthma control questionnaire score < 0.75 ( 56.6 % and 40.0 % , respectively ; P = 0.039 ) and a greater mean reduction in inhaled corticosteroid use ( 218.5 g and 126.2 g , respectively ; P = 0.004 ) .
RESULTS	The active vs placebo differences in disease control and corticosteroid use were not significant for mild , persistent asthma .
RESULTS	No treatment-related serious adverse events were reported .
CONCLUSIONS	Sublingual mite allergen immunotherapy was well tolerated in adult asthmatics and effectively controlled disease in patients with moderate ( but not mild ) persistent asthma ( ClinicalTrials.gov : NCT00660452 ) .

###25240070
BACKGROUND	The high prevalence and incidence of obesity and eating disorders in US adolescent girls are serious health problems .
BACKGROUND	Because of the shared risk factors for obesity and eating disorders , a targeted prevention of both conditions is a priority .
OBJECTIVE	We determined whether an adapted interpersonal psychotherapy prevention program is more efficacious for reducing excess weight gain and worsening disordered eating than health education in adolescent girls at high risk of obesity and eating disorders .
METHODS	A parallel-group , randomized controlled trial was conducted between September 2008 and January 2013 in a university-based laboratory and a federal research hospital .
METHODS	The study included 113 adolescent ( 12-17-y-old ) girls deemed at high risk of adult obesity and eating disorders because of a body mass index ( BMI ) between the 75th and 97th percentiles and reports of episodes of a loss of control over their eating .
METHODS	Girls were randomly assigned to participate in an adapted interpersonal psychotherapy or a health-education group program for 12 weekly 90-min group sessions .
METHODS	Follow-up assessments occurred immediately after group programs and at 6 and 12 mo. .
RESULTS	Participation in both conditions was associated with decreases in expected BMI gain , age-adjusted BMI metrics , the percentage of fat by using dual-energy X-ray absorptiometry , symptoms of depression and anxiety , and the frequency of loss-of-control eating over 12 mo of follow-up ( Ps < 0.001 ) with no group difference .
RESULTS	In follow-up analyses , interpersonal psychotherapy was more efficacious than health education at reducing objective binge eating at the 12-mo follow-up ( P < 0.05 ) .
CONCLUSIONS	The intervention with adolescent girls with loss-of-control eating is associated with lower age-adjusted BMI and percentage of adiposity as well as improved mood symptoms over 1 y. Interpersonal psychotherapy further reduced objective binge eating .
CONCLUSIONS	Additional research is needed to elucidate the mechanisms by which physical and psychological improvements were observed .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT00680979 .

###25156178
BACKGROUND	Conservative orthotic treatments rely on different mechanisms , such as three-point bending systems or hinges forcing external rotation of the leg and knee stabilization , to alter the biomechanics of the lower limbs and thus reduce knee loading on the affected compartment in patients with knee osteoarthritis ( KOA ) .
BACKGROUND	No previous study had compared the effects of these mechanisms on external loading and leg kinematics in patients with KOA .
METHODS	Twenty-four patients with medial KOA ( Kellgren-Lawrence grade II or III ) wore three custom knee braces : a valgus brace with a three-point bending system ( V3P-brace ) , an unloader brace with valgus and external rotation functions ( VER-brace ) and a functional knee brace used in ligament injuries ( ACL-brace ) .
METHODS	Pain relief , comfort , lower extremity kinematics and kinetics during walking were compared with and without each knee brace .
RESULTS	Knee pain was alleviated with all three braces ( p < 0.01 ) .
RESULTS	The VER - and ACL-braces allowed a significant reduction in peak knee adduction moment ( KAM ) during terminal stance from 0.313 to 0.280 Nm/BwHt ( p < 0.001 ) and 0.293 to 0.268 ( p < 0.05 ) , respectively , while no significant reduction was observed with the V3P-brace ( p = 0.52 ) .
RESULTS	Reduced knee adduction and lower ankle and knee external rotation were observed with the V3P-brace but not with the VER-brace .
RESULTS	The ACL-brace did not modify lower limb kinematics .
CONCLUSIONS	No difference between the knee braces was found for pain reduction , discomfort or KAM .
CONCLUSIONS	The VER-brace was slightly more comfortable , which could ensure better compliance with treatment over the long term .

###25065093
BACKGROUND	Preoperative oral carbohydrate ( CHO ) drink may improve patients ' comfort .
BACKGROUND	However , whether it prevents or reduces postoperative nausea and vomiting ( PONV ) is questionable .
OBJECTIVE	Evaluate the effect of oral rehydration with 10 % CHO drink before anesthesia on incidence and severity of postoperative nausea and vomiting ( PONV ) after spinal morphine injection .
METHODS	One hundred patients scheduled for unilateral total knee replacement ( TKR ) were randomly divided into two equal groups ( n = 50 each ) .
METHODS	Group I patients received 400 ml 10 % CHO drink the preoperative night and 2-hour before anesthesia , whereas Group II patients served as control .
METHODS	Spinal anesthesia for all patients contained 0.5 % bupivacaine 2.0 to 3.5 ml plus morphine 0.2 mg .
METHODS	Pain therapy was standardized with femoral nerve block , local infiltration , intravenous parecoxib , and oral paracetamol .
METHODS	Incidence and severity of PONV within 24 hours were recorded In addition , preoperative intensity of thirst and hunger , dry lips and throat , and anxiety was also recorded
RESULTS	Incidence and severity of PONV ( 81.2 % vs. 72.0 % , p = 0.536 ) as well as preoperative thirst , hunger dry lips , and throat were not different between the groups .
CONCLUSIONS	Preoperative oral rehydration with carbohydrate drinks had no positive effect on PONV nor patients ' comfort .

###25091714
BACKGROUND	Vitamin D is hypothesized to have some roles in innate and adaptive immunity , inflammation reduction , and remodeling ; therefore , it is supposed to affect the asthma phenotype , severity , and response to inhaled corticosteroid ( ICS ) .
OBJECTIVE	To explore the synergistic effects of vitamin D supplementation in addition to asthma controllers ( ICS or ICS plus long-acting - agonist ) on airway functions .
METHODS	A randomized clinical trial was conducted in 130 individuals aged 10 to 50 years who lived in Tehran during a 24-week period .
METHODS	Data on age , sex , body mass index , stage of asthma , serum total IgE , history of allergic rhinitis , atopic dermatitis , food allergy , and urticaria were collected .
METHODS	Spirometric parameters ( forced expiratory volume in 1 second [ FEV1 ] and ratio of FEV1 to forced vital capacity ) and serum vitamin D measurement were obtained before and 8 and 24 weeks after the intervention .
METHODS	Patients were divided in 2 groups randomly .
METHODS	Both groups received asthma controllers ( budesonide or budesonide plus formoterol ) according to their stage , but the intervention group received vitamin D supplementation ( 100,000-U bolus intramuscularly plus 50,000 U orally weekly ) in addition to asthma controllers .
RESULTS	FEV1 improved significantly in both groups after 8 weeks , but no significant difference was found between the 2 groups at baseline ( P = .20 ) or after 8 weeks ( P = .99 ) ; however , a significant improvement was seen in the intervention group in the last 16 weeks , and FEV1 was significantly better in the intervention group than the other group after 24 weeks ( P < .001 ) .
CONCLUSIONS	Vitamin D supplementation associated with asthma controllers could significantly improve FEV1 in mild to moderate persistent asthma after 24 weeks .
BACKGROUND	irct.ir Identifier : IRCT201302079608N1 .

###24719474
BACKGROUND	We report the first-in-human safety and immunogenicity assessment of a prototype hexon chimeric adenovirus ( Ad ) serotype 5 ( Ad5 ) vector containing the hexon hypervariable regions of Ad serotype 48 ( Ad48 ) and expressing human immunodeficiency virus ( HIV ) type 1 EnvA .
METHODS	Forty-eight Ad5 and Ad48 seronegative , HIV-uninfected subjects were enrolled in a randomized , double-blind , placebo-controlled , dose escalation phase 1 study .
METHODS	Four groups of 12 subjects received 10 ( 9 ) to 10 ( 11 ) viral particles ( vp ) of the Ad5HVR48.EnvA .01 vaccine ( n = 10 per group ) or placebo ( n = 2 per group ) at week 0 or weeks 0 , 4 , and 24 .
METHODS	Safety and immunogenicity were assessed .
RESULTS	Self-limited reactogenicity was observed after the initial immunization in the highest ( 10 ( 11 ) vp ) dose group .
RESULTS	Responses in vaccinees included Ad48 neutralizing antibody ( nAb ) titers higher than Ad5 nAb titers , EnvA-specific enzyme-linked immunosorbent assay titers , and EnvA-specific enzyme-linked immunospot assay responses , and these responses generally persisted at week 52 .
RESULTS	At week 28 in the 10 ( 9 ) , 10 ( 10 ) , and 10 ( 11 ) vp 3-dose groups , geometric mean EnvA enzyme-linked immunosorbent assay titers were 5721 , 10 929 , and 3420 , respectively , and Ad48 nAb titers were a median of 1.7-fold higher than for Ad5 .
CONCLUSIONS	Ad5HVR48.ENVA .01 was safe , well tolerated , and immunogenic at all doses tested .
CONCLUSIONS	Vector-elicited nAb responses were greater for Ad48 than Ad5 , confirming that Ad-specific nAbs in humans are primarily , but not exclusively , directed against the hexon hypervariable regions .
CONCLUSIONS	Clinical Trials Registration.NCT00695877 .

###24347261
OBJECTIVE	This study compared two methods of expanding the uterine incision at the time of cesarean delivery , which is associated with the risk of unintended extension .
METHODS	This randomized trial included 1,076 women who underwent elective cesarean delivery .
METHODS	The primary outcome measure was the incidence of unintended extension related to the method used for expanding the uterine incision .
RESULTS	Participants in both groups ( blunt vs. sharp ) had similar demographic and clinical characteristics .
RESULTS	The incidence of unintended extension ( 8.8 % vs. 4.8 % ; p = 0.009 ) , mean estimated blood loss ( 853.67 42 mL vs. 664.80 38 mL ; p = 0.001 ) , and blood loss > 1000 mL ( 11.4 % vs. 6.8 % ; p = 0.009 ) was significantly higher in the sharp group compared with the blunt group .
RESULTS	No difference in transfusions ( 7.5 % vs. 6.3 % ; p = 0.440 ) or the need for additional supertonic agents ( 16 % vs. 12.9 % ; p = 0.144 ) was noted .
CONCLUSIONS	Sharp expansion of the uterine incision was related to a higher risk of unintended extension and maternal blood loss .
CONCLUSIONS	Because blunt expansion is associated with a lower risk for unintended extension and maternal blood loss , it should be the first option during elective cesarean delivery .

###24973840
BACKGROUND	There is limited available information for treatment of acute coronary syndrome ( ACS ) with respect to outcomes , therapeutic agents and treatment practices .
BACKGROUND	Our retrospective registry study collected and evaluated varying anti-platelet treatment strategies and outcomes of ACS patients who were admitted to 9 different tertiary care hospitals in India .
BACKGROUND	This study was carried out to provide an insight to anti-platelet treatment patterns and analyze outcomes of ACS patients in India .
METHODS	All the relevant data , including anti-platelet treatment strategies , outcomes and patient treatment compliance were collected from 500 ACS ( defined as STEMI , NSTEMI and unstable angina [ UA ] ) cases from January 2007 to December 2009 .
METHODS	These ACS cases were randomly collected from the hospital records and included in the analysis .
METHODS	The patient follow up data was acquired either from the hospital records or via telephonic contact for a period of one year following the event .
RESULTS	Out of 500 ACS patients , 59.8 % had UA/NSTEMI and 40.2 % had STEMI .
RESULTS	On hospital admission , aspirin , clopidogrel , statins , beta-blockers and angiotensin converting enzyme inhibitors ( ACE-Is ) were used by 83 % , 83 % , 68 % , 43.2 % and 31.6 % patients , respectively .
RESULTS	On discharge , aspirin , clopidogrel , statins and beta-blockers were used by 90.2 % , 88 % , 80.6 % , and 59 % patients , respectively .
RESULTS	The average patient compliance to statins , clopidogrel and aspirin was recorded as 74.28 % , 69.7 % and 68.66 % , respectively during discharge and follow-up visits .
RESULTS	Greater than 50 % of ACS patients after discharge were lost to follow-up and as a result there was significant drop in the number of clinical events reported .
CONCLUSIONS	This pilot study conducted in tertiary care centers in India showed that patients with ACS were more often diagnosed with UA/NSTEMI as compared to STEMI and reported maximum compliance to statins , clopidogrel and aspirin after discharge over 1 year follow-up .
CONCLUSIONS	More ACS patients were lost to follow up that resulted in low reporting of clinical outcomes , following discharge upto 1 year .

###24650022
OBJECTIVE	To our knowledge , there is no evidence to support the use of local infiltration analgesia ( LIA ) for postoperative pain relief after periacetabular osteotomy ( PAO ) .
OBJECTIVE	We investigated the effect of wound infiltration with a long-acting local anesthetic ( ropivacaine ) for postoperative analgesia after PAO .
METHODS	We performed a randomized , double-blind , placebo-controlled trial ( ClinicalTrials.gov : NCT00815503 ) in 53 patients undergoing PAO to evaluate the effect of local anesthetic infiltration on postoperative pain and on postoperative opioid consumption .
METHODS	All subjects received intraoperative infiltration followed by 5 postoperative injections in 10-hour intervals through a multi-holed catheter placed at the surgical site .
METHODS	26 patients received ropivacaine and 27 received saline .
METHODS	The intervention period was 2 days and the observational period was 4 days .
METHODS	All subjects received patient-controlled opioid analgesia without any restrictions on the total daily dose .
METHODS	Pain was assessed at specific postoperative time points and the daily opioid usage was registered .
RESULTS	Infiltration with 75 mL ( 150 mg ) of ropivacaine did not reduce postoperative pain or opioid requirements during the first 4 days .
CONCLUSIONS	The clinical importance of ropivacaine as single component in postoperative treatment of pain is questionable , and we are planning further studies to explore the potential of LIA in larger volume-and also a multimodal regimen-to treat pain in this category of patients .

###25042931
OBJECTIVE	Patients with Becker muscular dystrophy ( BMD ) and Duchenne muscular dystrophy lack neuronal nitric oxide synthase ( nNOS ) .
OBJECTIVE	nNOS mediates physiological sympatholysis , thus ensuring adequate blood supply to working muscle .
OBJECTIVE	In mice lacking dystrophin , restoration of nNOS effects by a phosphodiesterase 5 ( PDE5 ) inhibitor ( sildenafil ) improves skeletal and cardiac muscle performance .
OBJECTIVE	Sildenafil also improves blood flow in patients with BMD .
OBJECTIVE	We therefore hypothesized that sildenafil would improve blood flow , maximal work capacity , and heart function in patients with BMD .
METHODS	A randomized , double-blind , placebo-controlled crossover design with two 4-week periods of treatment , separated by 2-week washout was used .
METHODS	We assessed brachial artery blood flow during maximal handgrip exercise , 6-minute walk test , maximal oxidative capacity , and life quality ; cardiac function was evaluated by magnetic resonance imaging ( MRI ) at rest and during maximal handgrip exercise .
METHODS	Muscle nNOS and PDE5 were tested with Western blotting in 5 patients .
RESULTS	Sixteen patients completed all skeletal muscle evaluations , and 13 completed the cardiac MRI investigations .
RESULTS	Sildenafil had no effect on any of the outcome parameters .
RESULTS	No serious adverse effects were recorded .
RESULTS	PDE5 and nNOS were deficient in 5 of 5 biopsies .
CONCLUSIONS	Despite positive evidence from animal models of dystrophinopathy and physiological findings in patients with BMD , this double-blind , placebo-controlled clinical study showed no effect of sildenafil on blood flow , maximal work capacity , and heart function in adults with BMD .
CONCLUSIONS	This discrepancy may be explained by a significant downregulation of PDE5 in muscle .

###24570327
OBJECTIVE	Contrast-induced nephropathy ( CIN ) is an important complication in the use of iodinated contrast media .
OBJECTIVE	The present study aimed to assess the safety and efficacy of prostaglandin E1 ( PGE1 ) in prevention of CIN in patients with high-risk factors undergoing percutaneous coronary intervention ( PCI ) .
METHODS	The study group consisted of 163 patients who had undergone a coronary intervention procedure between January 1 , 2012 and October 31 , 2012 .
METHODS	Study participants were randomly assigned to either the PGE1 group ( 82 patients ) or the control group ( 81 patients ) .
METHODS	Patients in the PGE1 group received PGE1 intravenous infusion of 20 ng/kg/min for 6 h before and after the administration of contrast media .
METHODS	The control group received 0.9 % sodium chloride solution for routine hydration only .
METHODS	A nonionic , low-osmolality contrast agent was used in our laboratory at this time .
METHODS	Serum creatinine ( Scr ) values and estimated glomerular filtration rate were measured before and within 48 h of the administration of contrast agents .
METHODS	CIN was defined as an increase of 0.5 mg/dL or a 25 % increase in Scr concentrations over baseline within 48 h of angiography .
RESULTS	The amount of contrast agent administered was similar for the PGE1 and control groups ( 156 63 vs. 161 68 mL , P > 0.05 ) .
RESULTS	The incidence of CIN was lower in the PGE1 group than in the control group ( 3.7 vs. 11.1 % , P < 0.05 ) .
RESULTS	No serious adverse effects were observed .
CONCLUSIONS	In patients with high-risk factors undergoing PCI , the use of PGE1 for prevention of CIN is safe and efficacious .

###24843954
OBJECTIVE	To explore the efficacy and the reproductive endocrinal mechanism of herbal-partitioned moxibustion in the treatment of primary dysmenorrhea .
METHODS	One hundred and seventy-one cases of primary dysmenorrhea were randomized into an herbal-partitioned moxibustion group ( group A ) , an starch-partitioned moxibustion group ( group B ) and an acupuncture group ( group C ) , 57 cases in each one .
METHODS	In the group A , moxibustion isolated with herbal medicine was applied to Shenque ( CV 8 ) .
METHODS	In the group B , moxibustion isolated with starch was used at Shenque ( CV 8 ) .
METHODS	In the group C , acupuncture was given at Sanyinjiao ( SP 6 ) .
METHODS	The changes of estradiol ( E2 ) , progesterone ( P ) and prostaglandin levels ( PGF2alpha ) were observed before and after treatment , and the therapeutic effects were compared among the 3 groups .
RESULTS	The therapeutic effect in the group A was better than those in the other two groups [ compared the cured rate : 89.8 % ( 44/49 ) vs 60.0 % ( 30/50 ) , 60.4 % ( 32/53 ) , both P < 0.05 ] .
RESULTS	In the group A , E2 level [ ( 110.99 + / - 12.90 ) pg/mL vs ( 83.94 + / - 8.91 ) pg/mL , P < 0.05 ] and PGF2alpha level [ ( 24.58 + / - 3.01 ) pg/mL vs ( 14.34 + / - 1.48 ) pg/mL , P < 0.01 ] were decreased and P level was increased [ ( 4.65 + / - 0.68 ) ng/mL vs ( 6.68 + / - 0.95 ) pg/mL , P < 0.05 ] .
RESULTS	In the group B and C , PGF2alpha level were reduced .
RESULTS	Concerning to the regulating of E2 and PGF2alpha levels , the results in the group A were better than those in the group B and C [ ( -30.16 + / - 10.20 ) pg/mL vs ( 10.79 + / - 15.01 ) pg/mL , ( 22.81 + / - 12.22 ) pg/mL ; ( -13.10 + / - 2.40 ) pg/mL vs ( -6.52 + / - 1.88 ) pg/mL , ( -3.14 + / - 1.19 ) pg/mL , ( see text ) P < 0.05 ] .
RESULTS	Concerning to the regulation of P level , the results in the group A and B were better than that in the group C ( all P < 0.05 ) .
CONCLUSIONS	The herbal-partitioned moxibustion achieves the significant efficacy on primary dysmenorrhea , which could be related to regulating the reproductive endocrinal level .
CONCLUSIONS	It decreases E2 and PGF2alpha levels and increases P level .

###25437218
OBJECTIVE	To determine if using freshest available rather than standard-issue red blood cells ( RBCs ) can reduce mortality in critically ill intensive care unit patients .
OBJECTIVE	Our study is the largest ongoing randomised controlled trial ( RCT ) of RBC age in critically ill patients and will help determine if the use of the freshest available RBCs should become standard policy for the critically ill .
METHODS	A double-blind , multicentre , Phase III RCT of 5000 adult ICU patients in Australia , New Zealand , Europe and the Middle East .
METHODS	Transfusion of the freshest available RBCs in place of standard-care RBCs until hospital discharge .
METHODS	The primary outcome measure is 90-day all-cause mortality .
METHODS	Secondary outcome measures are time to death , 28-day and 180-day mortality , persistent organ dysfunction combined with death , days alive and free of mechanical ventilation and renal replacement therapy , bloodstream infection in the ICU , length of stay in the ICU and in hospital , proportion of patients with febrile non-haemolytic transfusion reactions , and quality of life at Day 180 .
RESULTS	A detailed statistical analysis plan with predefined subgroups and secondary analyses has been finalised before results being available , to ensure an unbiased final analysis .
CONCLUSIONS	The pragmatic protocol design has been chosen to facilitate translation of the trial results into practice .
CONCLUSIONS	The TRANSFUSE trial will have important clinical and policy implications , regardless of the outcome .

###24839251
OBJECTIVE	To investigate whether acute total sleep deprivation ( TSD ) leads to decreased cognitive control when food cues are presented during a task requiring active attention , by assessing the ability to cognitively inhibit prepotent responses .
METHODS	Fourteen males participated in the study on two separate occasions in a randomized , crossover within-subject design : one night of TSD versus normal sleep ( 8.5 hours ) .
METHODS	Following each nighttime intervention , hunger ratings and morning fasting plasma glucose concentrations were assessed before performing a go/no-go task .
RESULTS	Following TSD , participants made significantly more commission errors when they were presented `` no-go '' food words in the go/no-go task , as compared with their performance following sleep ( +56 % ; P < 0.05 ) .
RESULTS	In contrast , response time and omission errors to `` go '' non-food words did not differ between the conditions .
RESULTS	Self-reported hunger after TSD was increased without changes in fasting plasma glucose .
RESULTS	The increase in hunger did not correlate with the TSD-induced commission errors .
CONCLUSIONS	Our results suggest that TSD impairs cognitive control also in response to food stimuli in healthy young men .
CONCLUSIONS	Whether such loss of inhibition or impulsiveness is food cue-specific as seen in obesity-thus providing a mechanism through which sleep disturbances may promote obesity development-warrants further investigation .

###25377966
OBJECTIVE	Our objective was to demonstrate the effects of platelet-rich fibrin ( PRF ) for the healing of acute ear drum perforation .
METHODS	Thirty-two patients with acute traumatic ear drum perforations were randomly separated into 2 groups .
METHODS	In group 1 ( n = 14 ) , PRF was used for the repair of ear drum perforation ; in group 2 ( n = 18 ) , we did not make any intervention .
RESULTS	At initial inspection , perforation sizes were measured as 10.93 3.58 mm in group 1 and 10.05 4.02 mm in group 2 .
RESULTS	After 1 month , perforation sizes were 1.35 2.53 mm in group 1 and 4.44 3.34 mm in group 2 ( P < 0.01 ) .
RESULTS	In the study group , the rate of ear drum closure was 64.3 % and in the control group it was 22.2 % ( P < 0.05 ) .
CONCLUSIONS	Here we found that PRF is a biomaterial that quickens the healing of ear drum which is autogenous and simply prepared .

###25093728
OBJECTIVE	To investigate the effectiveness of educational poster on improving secondary school students ' knowledge of emergency management of dental trauma .
METHODS	A cluster randomised controlled trial was conducted .
METHODS	16 schools with total 671 secondary students who can read Chinese or English were randomised into intervention ( poster , 8 schools , 364 students ) and control groups ( 8 schools , 305 students ) at the school level .
METHODS	Baseline knowledge of dental trauma was obtained by a questionnaire .
METHODS	Poster containing information of dental trauma management was displayed in a classroom for 2 weeks in each school in the intervention group whereas in the control group there was no display of such posters .
METHODS	Students of both groups completed the same questionnaire after 2 weeks .
RESULTS	Two-week display of posters improved the knowledge score by 1.25 ( p-value = 0.0407 ) on average .
CONCLUSIONS	Educational poster on dental trauma management significantly improved the level of knowledge of secondary school students in Hong Kong .
BACKGROUND	HKClinicalTrial.com HKCTR-1343 ClinicalTrials.gov NCT01809457 .

###24715012
OBJECTIVE	To describe the design , methods , and challenges encountered during a randomized clinical trial aimed to promote water intake for reducing risks of metabolic syndrome in Mexican women .
METHODS	In a randomized clinical trial in Cuernavaca , Mexico , overweight and obese ( body mass index [ BMI ] 25 < 39 ) women , 18 - < 45 years old with an intake of sugar-sweetened beverages 250 kilocalories per day ( kcal/day ) were randomly allocated to the water and education provision group ( n = 120 ) or the education provision only group ( n = 120 ) .
RESULTS	We screened 1 756 women .
RESULTS	The main difficulties encountered were identifying participants with the recruitment criteria , delivering water to participants , and the time demanded from the study participants .
CONCLUSIONS	The trial 's main challenges were difficulties surrounding recruitment , delivery of the intervention , and the time demanded from the study participants .
CONCLUSIONS	Modifications were effectively implemented without jeopardizing the original protocol .

###24645942
BACKGROUND	Early decompressive hemicraniectomy reduces mortality without increasing the risk of very severe disability among patients 60 years of age or younger with complete or subtotal space-occupying middle-cerebral-artery infarction .
BACKGROUND	Its benefit in older patients is uncertain .
METHODS	We randomly assigned 112 patients 61 years of age or older ( median , 70 years ; range , 61 to 82 ) with malignant middle-cerebral-artery infarction to either conservative treatment in the intensive care unit ( the control group ) or hemicraniectomy ( the hemicraniectomy group ) ; assignments were made within 48 hours after the onset of symptoms .
METHODS	The primary end point was survival without severe disability ( defined by a score of 0 to 4 on the modified Rankin scale , which ranges from 0 [ no symptoms ] to 6 [ death ] ) 6 months after randomization .
RESULTS	Hemicraniectomy improved the primary outcome ; the proportion of patients who survived without severe disability was 38 % in the hemicraniectomy group , as compared with 18 % in the control group ( odds ratio , 2.91 ; 95 % confidence interval , 1.06 to 7.49 ; P = 0.04 ) .
RESULTS	This difference resulted from lower mortality in the surgery group ( 33 % vs. 70 % ) .
RESULTS	No patients had a modified Rankin scale score of 0 to 2 ( survival with no disability or slight disability ) ; 7 % of patients in the surgery group and 3 % of patients in the control group had a score of 3 ( moderate disability ) ; 32 % and 15 % , respectively , had a score of 4 ( moderately severe disability [ requirement for assistance with most bodily needs ] ) ; and 28 % and 13 % , respectively , had a score of 5 ( severe disability ) .
RESULTS	Infections were more frequent in the hemicraniectomy group , and herniation was more frequent in the control group .
CONCLUSIONS	Hemicraniectomy increased survival without severe disability among patients 61 years of age or older with a malignant middle-cerebral-artery infarction .
CONCLUSIONS	The majority of survivors required assistance with most bodily needs .
CONCLUSIONS	( Funded by the Deutsche Forschungsgemeinschaft ; DESTINY II Current Controlled Trials number , ISRCTN21702227 . )

###24370303
OBJECTIVE	To observe the clinical efficacy of tetrandrine combined with acetylcysteine effervescent tablets in the treatment of silicosis .
METHODS	A total of 96 patients with silicosis were randomly divided into treatment group ( 49 cases ) and control group ( 47 cases ) .
METHODS	Both groups were given routine therapy including anti-inflammatory , antitussive , and antiasthmatic drugs , and the patients in treatment group were given tetrandrine combined with acetylcysteine effervescent tablets at the same time .
METHODS	Tetrandrine ( 100 mg ) was orally administrated twice a day , and there was a one-day interval between every 6 days ' continuous administration ; totally , there were four courses of treatment , with 3 months for each course , and there was a one-month break between each course .
METHODS	Acetylcysteine effervescent tablets ( 600 mg ) were taken twice a day ; each course of treatment was 12 days , and there were four courses ; for the first two months , there was one course per month , and then one course every other two months for the rest of time .
METHODS	Clinical symptoms , pulmonary ventilation function , serum superoxide dismutase ( SOD ) and changes in X-ray findings were observed .
RESULTS	After treatment , the treatment group had significantly increased rates of improvements in cough , expectoration , chest congestion and pain , and dyspnea compared with the control group ( P < 0.05 ) .
RESULTS	Compared with the control group ( serum SOD level : 70.46620.261 U/ml ) and the treatment group before therapy ( serum SOD level : 68.18221.414 U/ml ) , the treatment group after therapy had significantly increased serum SOD level ( 77.38921.315 U/ml ?
RESULTS	, forced vital capacity , and forced expiratory volume in one second ( P < 0.05 ) .
RESULTS	Eight patients in treatment group showed improvement in the chest X-ray findings of silicosis .
CONCLUSIONS	The combination of tetrandrine and acetylcysteine effervescent tablets show some effect in the treatment of silicosis .
CONCLUSIONS	It can be an effective option for treating silicosis as there are no other specific remedies .

###24393328
BACKGROUND	Chronic subdural hematoma ( cSDH ) is a common neurosurgical disease .
BACKGROUND	It is often considered to be a rather benign entity .
BACKGROUND	In spite of well established surgical procedures cSDH is complicated by a recurrence rate up to 30 % .
BACKGROUND	Since glucocorticoids have been used for treatment of cSDH in 1962 their role is still discussed controversially in lack of evident data .
BACKGROUND	On the basis of the ascertained inflammation cycle in cSDH dexamethasone will be an ideal substance for a short lasting , concomitant treatment protocol .
OBJECTIVE	to test the efficacy of dexamethasone on reduction inthe reoperation rate of cSDH .
METHODS	The study is designed as a double-blind randomized placebo-controlled trial 820 patients who are operated for cSDH and from the age of 25 years are included after obtaining informed consent .
METHODS	They are randomized for administration of dexamethasone ( 16-16-12-12-8-4mg / d ) or placebo ( maltodextrin ) during the first 48 hours after surgery .
METHODS	The type I error is 5 % and the type II error is 20 % .
METHODS	The primary endpoint is the reoperation within 12 weeks postoperative .
CONCLUSIONS	This study tests whether dexamethasone administered over 6 days is a safe and potent agent in relapse prevention for evacuated cSDH .
BACKGROUND	EudraCT 201100354442 .

###25263143
BACKGROUND	In this randomized , placebo-controlled clinical trial , we investigated the effect of noninvasive extracorporeal shock waves on the stability of temporary anchorage devices ( TADs ) under orthodontic loading .
METHODS	Thirty adult orthodontic patients of the Bernhard Gottlieb University Clinic in Vienna , Austria , were enrolled in this clinical trial and allocated by block randomization ( size , 4 ) in a 1:1 ratio to either the treatment or the placebo group .
METHODS	Randomization was performed with software , and the allocations were concealed in sealed envelopes .
METHODS	Eligibility criteria included healthy adult patients with mesially directed orthodontic movement of the mandibular second molar into the extraction site of the mandibular first molar .
METHODS	The fixed orthodontic devices included active superelastic coil springs ( 200cN ) and TADs in the mandibular alveolar bone .
METHODS	Blinding was performed for the subjects and the outcome assessor .
METHODS	The treatment group received 1 shock-wave application with 1000 impulses at 0.19 to 0.23 mJ per square millimeter in the region of the TADs .
METHODS	The placebo group was treated with a deactivated shock-wave applicator and acoustic sham .
METHODS	The TADs positions were evaluated at placement and after 4months .
METHODS	The reliability and precision of the impression process of the TADs were evaluated in an in-vitro model .
RESULTS	Thirteen participants finished the investigation successfully in the treatment group but only 12 finished in the placebo group because 1 TAD loosened .
RESULTS	The difference of the total TAD displacement for the 4-month time period between the placebo and treatment groups was 0.170.95 mm ( 95 % CI : -0.96 , 0.62 ) .
RESULTS	No statistically significant difference between the 2 groups was found when sex was evaluated .
RESULTS	Primary stability of the TADs as measured by placement torque , amount of tooth movement , and age of the patients did not influence displacement of the TADs .
RESULTS	The reliability and precision of TAD impressions were confirmed .
RESULTS	No unintended pernicious effects occurred after shock-wave treatment during the study period .
CONCLUSIONS	A single application of extracorporeal shock-wave treatment did not improve the stability of the TADs during orthodontic loading .
CONCLUSIONS	Sufficient interradicular space should be provided to minimize the risk of periodontal and dental root defects .
BACKGROUND	This trial was registered at https://clinicaltrials.gov .
METHODS	The protocol was published before trial commencement , NCT01695928 .
BACKGROUND	No funding or conflict of interest to be declared .

###25103138
OBJECTIVE	To investigate the reliability and agreement of measures of lower extremity muscle strength , power and functional performance in patients with hip osteoarthritis at different time intervals , and to compare these with the same measures in healthy peers .
METHODS	Intra-rater test-retest separated by 1 , 2 , or 2.5 weeks in patients , and 1 week in healthy peers .
METHODS	Patients with hip osteoarthritis ( age range 61-83 years ) with 1 ( n = 37 ) , 2 ( n = 35 ) , or 2.5 weeks ( n = 15 ) between tests , and 35 healthy peers ( age range 63-82 years ) .
METHODS	Maximal isometric hip and thigh strength , leg extensor power , and functional performance ( 8-foot Up & Go , stair climbing , chair stand and 6-min walk ) were measured in patients , and quadriceps strength , leg extensor power and functional performance were measured in healthy peers .
METHODS	Systematic error , reliability and agreement were calculated .
RESULTS	Most hip strength measurements for the most symptomatic extremity , and nearly all strength measurements for the least symptomatic lower extremity , declined after 1 week ( p < 0.05 ) , but not after a 2.5-week interval .
RESULTS	In healthy peers , quadriceps strength was unchanged .
RESULTS	Regardless of the time interval , leg extensor power was unchanged , while functional performances improved at retest for all participants .
CONCLUSIONS	In patients with hip osteoarthritis leg extensor power is unaffected by the time interval between tests , in contrast to muscle strength and functional performance .

###24972577
OBJECTIVE	To observe the efficacy and the influence on quality of life ( QOL ) of syndrome differentiation treatment with Chinese medicine ( CM ) for opioid-induced constipation as well as the safety and influence on analgesic effect of opioids .
METHODS	Totally 406 cases enrolled from 53 collaborating medical centers were randomly assigned to a CM group and a control group .
METHODS	The CM group were treated with CM decoction based on syndrome differentiation , and the control group were treated with Phenolphthalein Tablet .
METHODS	Both groups were treated for 14 days .
METHODS	Cleveland constipation score ( CCS ) , numerical rating scale ( NRS ) of pain and Chinese version of European Organisation for Research and Treatment of Cancer , Quality of Life Questionnaire-C30 V3 .0 ( EORTC QLQ-C30 V3 .0 ) were used to evaluate the efficacy , pain controlled and QOL status .
RESULTS	The comparisons of CCS score reduction and QOL between the two groups after treatment suggested that the improvements of constipation and QOL in the CM group were better than that in the control group ( P < 0.05 ) .
RESULTS	The total efficiency of the CM group was better than the control group ( 93.5 % vs. 86.4 % , P < 0.05 ) .
RESULTS	There was no significant difference in NRS scores between before and after treatment in both groups .
RESULTS	There was no serious drug-related adverse event during the course of study .
CONCLUSIONS	CM decoction could effectively treat opioid-induced constipation and improve patients ' QOL at the same time .
CONCLUSIONS	It is safe and does n't affect the analgesic effect of opioids when treating constipation .

###24961816
OBJECTIVE	To compare safety and efficacy of pantoprazol , metoclopramide , ondansetron , as compared to placebo , in controlling gastrointestinal ( GI ) complaints of thyroid cancer patients treated with I-131these patients .
METHODS	Four-armed , parallel group , single blind , randomized controlled clinical trial , setting : A university hospital , registration : database for clinical trials IRCT2013061713705N1 .
METHODS	85 patients with differentiated thyroid cancer who received 131I .
METHODS	Postradioiodine nausea and vomiting within three days of therapy ( primary endpoint ) ; occurrence of adverse reaction .
RESULTS	The patients ' characteristics were similar within the study groups .
RESULTS	Among the study variables , age , sex , administered dosage , history of previous GI complaints , and history of hyperemesis gravidarum in female patients were not statistically different among the groups ( p > 0.05 ) .
RESULTS	The results revealed that only ondansetron shows a therapeutic benefit over the placebo in controlling nausea ( p < 0.05 ) ; however , it does not prevent vomiting ( p > 0.05 ) .
RESULTS	The other two drugs , pantoprazole and metoclopramide , did not control nausea ( p > 0.05 ) or vomiting ( p > 0.05 ) .
CONCLUSIONS	This study may demonstrate that the therapeutic dose of ondansetron could be an effective prophylactic agent in controlling GI complaints in differential thyroid carcinoma ( DTC ) patients following RAI therapy ; however , these preliminary findings should be validated in larger studies .

###24678571
OBJECTIVE	To conduct a process and impact evaluation of a multifaceted education-based pilot program targeting correct use of age-appropriate restraints in a regional setting with a high proportion of Aboriginal and Torres Strait Islander families .
METHODS	The program was delivered in 2010 in 3 early learning centers where 31 percent of the children were of Aboriginal and Torres Strait Islander descent .
METHODS	Each component of the program was assessed for message consistency and uptake .
METHODS	To measure program effectiveness , participating children were matched 1:1 by age , language spoken at home , and annual household income with 71 children from the control arm of a contemporaneous trial .
METHODS	The outcome measure in the control and program centers ( a 4-category ordinal scale of restraint use ) was compared using ordinal logistic regression accounting for age of the parent .
RESULTS	Process evaluation found that though program components were delivered with a consistency of message , uptake was affected by turnover of all staff at one center and by parents experiencing difficulty in paying for subsidized restraints at each of the centers .
RESULTS	Impact evaluation found that children from the centers receiving the program had nearly twice the odds of being in a better restraint category than children matched from the control group ( adjusted odds ratio [ ORadj ] = 2.06 , 95 % confidence interval [ CI ] , 1.09-3 .90 ) .
CONCLUSIONS	This was a pragmatic study reflecting the real-life issues of implementing a program in preschools where 57 percent of families had a low income and turnover of staff was high .
CONCLUSIONS	Despite these issues , impact evaluation showed that the integrated educational program showed promise in increasing correct use of age-appropriate restraints .
CONCLUSIONS	The findings from this pilot study support the use of an integrated educational program that includes access to subsidized restraints to promote best practice child restraint use among communities that include a high proportion of Aboriginal and Torres Strait Islander families in New South Wales .
CONCLUSIONS	Future trials in similar settings should consider offering more support in centers with high turnover of staff and offering alternative methods of payment when families experience financial difficulties in purchasing the subsidized restraints .
CONCLUSIONS	If proven in larger trials , this approach could reduce death and injuries in child passengers in this vulnerable group .

###24812891
OBJECTIVE	To evaluate the anginal attack-relieving efficacy and safety of Kuanxiong Aerosol ( KA ) in patients with coronary heart disease ( CHD ) .
METHODS	A total of 780 patients confirmatively diagnosed as CHD angina from November 2011 to December 2012 in 13 medical centers in the mainland area were assigned to 2 groups by blocked randomization , the treatment group ( 376 cases ) and the control group ( 374 cases ) .
METHODS	When the angina attacked , patients in the treatment group received sublingual spray three times , 0.6 mL each time , while those in the control group sublingually dissolved Nitroglycerin Tablet ( NT ) , 0.5 mg each tablet .
METHODS	The effective rate of angina relief , efficacy of electrocardiogram ( ECG ) , and the incidence of adverse reactions were observed .
RESULTS	The 3 min and 5 min remission rates of angina attack were 53.72 % ( 202/376 ) and 94.41 % ( 355/376 ) in the treatment group , and 47.86 % ( 179/374 ) and 90.64 % ( 339/374 ) in the control group .
RESULTS	The 95 % confidence interval ( CI ) of the difference between the 2 groups of 3 min and 5 min remission rates of angina attacks were [ ( -1.84 % , 12.32 % ) and ( -1.33 % , 6.85 % ) respectively , P > 0.05 ] .
RESULTS	The total improvement rates of ST-T changes in the treatment group and the control group after treatment were 74.07 % and 73.13 % respectively ( P > 0.05 ) .
RESULTS	The adverse reaction rate was 9.31 ( 35/376 cases ) in the treatment group and 22.46 % ( 84/374 cases ) in the control group ( P < 0.01 ) .
CONCLUSIONS	KA was not inferior to NT in relieving anginal attacks and improving ischemic ECG changes , and had obviously less adverse reaction .

###24650219
BACKGROUND	Research directed to optimizing maternal nutrition commencing prior to conception remains very limited , despite suggestive evidence of its importance in addition to ensuring an optimal nutrition environment in the periconceptional period and throughout the first trimester of pregnancy .
METHODS	This is an individually randomized controlled trial of the impact on birth length ( primary outcome ) of the time at which a maternal nutrition intervention is commenced : Arm 1 : 3 mo preconception vs. Arm 2 : 12-14 wk gestation vs. Arm 3 : none .192 ( derived from 480 ) randomized mothers and living offspring in each arm in each of four research sites ( Guatemala , India , Pakistan , Democratic Republic of the Congo ) .
METHODS	The intervention is a daily 20 g lipid-based ( 118 kcal ) multi-micronutient ( MMN ) supplement .
METHODS	Women randomized to receive this intervention with body mass index ( BMI ) < 20 or whose gestational weight gain is low will receive an additional 300 kcal/d as a balanced energy-protein supplement .
METHODS	Researchers will visit homes biweekly to deliver intervention and monitor compliance , pregnancy status and morbidity ; ensure prenatal and delivery care ; and promote breast feeding .
METHODS	The primary outcome is birth length .
METHODS	Secondary outcomes include : fetal length at 12 and 34 wk ; incidence of low birth weight ( LBW ) ; neonatal/infant anthropometry 0-6 mo of age ; infectious disease morbidity ; maternal , fetal , newborn , and infant epigenetics ; maternal and infant nutritional status ; maternal and infant microbiome ; gut inflammatory biomarkers and bioactive and nutritive compounds in breast milk .
METHODS	The primary analysis will compare birth Length-for-Age Z-score ( LAZ ) among trial arms ( independently for each site , estimated effect size : 0.35 ) .
METHODS	Additional statistical analyses will examine the secondary outcomes and a pooled analysis of data from all sites .
CONCLUSIONS	Positive results of this trial will support a paradigm shift in attention to nutrition of all females of child-bearing age .
BACKGROUND	ClinicalTrials.gov NCT01883193 .

###25637849
OBJECTIVE	The objective of the study was to evaluate objective and subjective outcomes of MiniArc and Monarc ( American Medical Systems , Minnetonka , MN ) midurethral sling ( MUS ) in women with stress incontinence at 12 months .
METHODS	A total of 225 women were randomized to receive MiniArc or Monarc .
METHODS	Women with intrinsic sphincter deficiency , previous MUS , or untreated detrusor overactivity were excluded .
METHODS	Objective cure was defined as negative cough stress test with a comfortably full bladder .
METHODS	Subjective cure was defined as no report of leakage with coughing or exercise on questionnaire .
METHODS	Validated questionnaires , together with urodynamic and clinical cough stress test , were used to evaluate the objective and subjective outcomes following surgery .
METHODS	Participants and clinicians were not masked to treatment allocation .
METHODS	Outcomes were compared with exact binomial tests ( eg , Fisher exact test for dichotomous data ) for categorical data and Student t tests or exact versions of Wilcoxon tests for numerical data as appropriate .
RESULTS	There was no statistically significant difference in the subjective ( 92.2 % vs 94.2 % ; P = .78 ; difference , 2.0 % ; 95 % confidence interval , -2.7 % to +6.7 % ) or objective ( 94.4 % vs 96.7 % ; P = .50 ; difference , 2.3 % ; 95 % confidence interval , -1.5 % to +6.1 % ) cure rates between MiniArc and Monarc at 12 m , respectively , with a significant improvement in overactive bladder outcomes and incontinence impact from baseline in both arms .
CONCLUSIONS	MiniArc outcomes are not inferior to Monarc MUS outcomes at 12 months ' follow-up in women without intrinsic sphincter deficiency .

###25645164
OBJECTIVE	Examine the efficacy of a parent-augmented One-Session Treatment ( A-OST ) in treating specific phobias ( SP ) in youth by comparing this novel treatment to child-focused OST , a well-established treatment .
METHODS	A total of 97 youth ( ages 6-15 , 51.5 % female , 84.5 % White ) who fulfilled diagnostic criteria for SP were randomized to either A-OST or OST .
METHODS	SPs were assessed with semistructured diagnostic interviews , clinician improvement ratings , and parent and child improvement ratings .
METHODS	In addition , measures of treatment satisfaction and parental self-efficacy were obtained .
METHODS	Blind assessments were completed pretreatment , posttreatment , and 1month and 6months following treatment .
METHODS	Analyses were undertaken using mixed models .
METHODS	In addition , gender , age , internalizing/externalizing problems , parent overprotection , and parent anxiety were examined as potential predictors and moderators of treatment outcome .
RESULTS	Both treatment conditions produced similar outcomes with approximately 50 % of youth in both treatments diagnosis free and judged to be much or very much improved at posttreatment and 1-month follow-up .
RESULTS	At 6-month follow-up , however , the treatments diverged with OST resulting in marginally superior outcomes to A-OST , contrary to predictions .
RESULTS	Only age of child predicted treatment outcome across the two treatments ( older children did better ) ; unexpectedly , none of the variables moderated treatment outcomes .
CONCLUSIONS	Parent augmentation of OST produced no appreciable gains in treatment outcomes .
CONCLUSIONS	Directions for future research are highlighted .

###24330472
BACKGROUND	In northern Vietnam the Neonatal health - Knowledge Into Practice ( NeoKIP , Current Controlled Trials ISRCTN44599712 ) trial has evaluated facilitation as a knowledge translation intervention to improve neonatal survival .
BACKGROUND	The results demonstrated that intervention sites , each having an assigned group including local stakeholders supported by a facilitator , lowered the neonatal mortality rate by 50 % during the last intervention year compared with control sites .
BACKGROUND	This process evaluation was conducted to identify and describe mechanisms of the NeoKIP intervention based on experiences of facilitators and intervention group members .
METHODS	Four focus group discussions ( FGDs ) were conducted with all facilitators at different occasions and 12 FGDs with 6 intervention groups at 2 occasions .
METHODS	Fifteen FGDs were audio recorded , transcribed verbatim , translated into English , and analysed using thematic analysis .
RESULTS	Four themes and 17 sub-themes emerged from the 3 FGDs with facilitators , and 5 themes and 18 sub-themes were identified from the 12 FGDs with the intervention groups mirroring the process of , and the barriers to , the intervention .
RESULTS	Facilitators and intervention group members concurred that having groups representing various organisations was beneficial .
RESULTS	Facilitators were considered important in assembling the groups .
RESULTS	The facilitators functioned best if coming from the same geographical area as the groups and if they were able to come to terms with the chair of the groups .
RESULTS	However , the facilitators ' lack of health knowledge was regarded as a deficit for assisting the groups ' assignments .
RESULTS	FGD participants experienced the NeoKIP intervention to have impact on the knowledge and behaviour of both intervention group members and the general public , however , they found that the intervention was a slow and time-consuming process .
RESULTS	Perceived facilitation barriers were lack of money , inadequate support , and the function of the intervention groups .
CONCLUSIONS	This qualitative process evaluation contributes to explain the improved neonatal survival and why this occurred after a latent period in the NeoKIP project .
CONCLUSIONS	The used knowledge translation intervention , where facilitators supported multi-stakeholder coalitions with the mandate to impact upon attitudes and behaviour in the communes , has low costs and potential for being scaled-up within existing healthcare systems .

###26363164
OBJECTIVE	To compare normal saline ( NS ) vs. NS + budesonide irrigations in post - functional endoscopic sinus surgery ( FESS ) patients with chronic rhinosinusitis with polyposis ( CRSwNP ) .
OBJECTIVE	Currently , no evidence exists for NS + budesonide irrigation over NS irrigation alone .
METHODS	Prospective , single-blind , randomized controlled trial .
METHODS	Subjects were prospectively enrolled to NS or NS + budesonide arms .
METHODS	Patients were evaluated at pre-operative and three post-operative visits ( POV ) : POV1 ( 1-2 weeks post-op ) , POV2 ( 3-8 weeks post-op ) , and POV3 ( 3-6 months post-op ) .
METHODS	Patients were evaluated by three quality of life ( QOL ) questionnaires ( SNOT-22 , RSOM-31 , and RSDI ) and two olfaction scores ( UPSIT and the PEA test ) .
RESULTS	Fifty patients were randomized , with 25 patients in the NS arm and 25 patients in the NS + budesonide arm .
RESULTS	Two patients had unexpected pathology and were excluded from the study .
RESULTS	By POV2 and POV3 , patients experienced a significant improvement in all three QOL surveys , although the degree of improvement between arms was not significant up through POV3 .
RESULTS	Neither arm experienced significant olfactory improvement up through POV3 .
CONCLUSIONS	While both NS and NS + budesonide treatments improve QOL for post-FESS patients , neither intervention significantly increases QOL as compared to the other .
CONCLUSIONS	Olfaction was not significantly improved in either treatment group .

###26156901
OBJECTIVE	The aim of this study was to evaluate the effectiveness of Quetiapine versus Risperidone in control of acute psychotic signs and symptoms in hospitalized patients during four weeks .
METHODS	In this double-blind , randomized controlled study , a total of 90 patients with a confirmed diagnosis acute psychosis and were hospitalized in Zare Hospital , Sari , Iran , and they were treated with Quetiapine ( mean 500 mg/day ) or Risperidone ( mean 5.2 mg/day ) , in a 4 week period .
METHODS	The positive and negative symptoms scale ( PANSS ) and Clinical Global Impression-Severity scale ( CGI-s ) were used to assess psychotic symptoms and severity of illness in first and the last day of the study .
RESULTS	No significant difference found between two groups in decreasing positive and negative sub-scores in the PANSS .
RESULTS	Risperidone was superior to Quetiapine in decreasing the PANSS general psychopathology sub-scores and total score ( p < 0.05 ) .
RESULTS	No significant difference found between two groups in decreasing CGI-s score .

###25501100
OBJECTIVE	This study aimed to investigate the feasibility and effects of intramuscular injections of autologous bone marrow cells ( BMC ) combined with off-pump coronary artery bypass grafts ( OPCAB ) on improving cardiac function in chronic myocardial infarction patients .
METHODS	Ninety patients with chronic myocardial infarction were prospectively enrolled and randomized to an OPCAB with saline or an OPCAB with BMC-treatment group .
METHODS	After finishing CABG , patients received injections of BMC or saline into the marginal area of the infarct .
METHODS	The primary endpoint was incidence of emergent adverse events within 6 months .
RESULTS	There were no differences between the control and BMC-treated groups in baseline ejection fractions ( EF ) or wall motion score indices ( WMSI ) in the affected segments .
RESULTS	At the 6-month follow-up , the ejection fraction was significantly increased in the BMC-treated group compared to controls ( 47.58 6.34 vs. 40.11 7.42 ; p < 0.05 ) , whereas the WMSI were significantly decreased ( 1.25 0.32 vs. 1.54 0.53 ; p < 0.05 ) , with no occurrences of life-threatening arrhythmias or death .
RESULTS	The addition of BMC injections to OPCAB treatment increased regional perfusion to the marginal infarct area .
CONCLUSIONS	These results demonstrate that BMC transplant is beneficial to the cardiac function with no adverse effects , and therefore a safe and feasible adjunct therapy providing beneficial effects in clinical practice .

###24576877
OBJECTIVE	To evaluate the influence of topographic profiles ( i.e. , inner directional angle and angular width ) of localized retinal nerve fiber layer ( RNFL ) defects on the diagnostic performance of macular ganglion cell-inner plexiform layer ( GCIPL ) thickness in discriminating preperimetric glaucoma ( PPG ) eyes from normal control eyes .
METHODS	The ganglion cell analysis algorithm in Cirrus OCT was performed to determine the macular GCIPL thickness .
METHODS	Areas under the receiver operating characteristic curves ( AUROCs ) and the sensitivities/specificities based on an internal normative database were evaluated .
METHODS	The effect of the inner directional angle and the angular width of localized RNFL defects on the diagnostic performance of macular GCIPL parameters were evaluated by using linear-by-linear association analysis and logistic regression analysis .
RESULTS	Ninety-two patients with PPG and 92 age-matched healthy control subjects were enrolled in this study .
RESULTS	The AUROC of the best parameters in macular GCIPL was 0.823 ( inferotemporal sector ) , which showed no significant difference in comparison to the best parameters of peripapillary RNFL ( 7 o'clock sector , 0.764 ) and optic nerve head ( rim area , 0.767 ) ( for all comparisons , P > 0.05 ) .
RESULTS	A significant linear association was observed between the inner directional angle of RNFL defects and the sensitivity of macular GCIPL parameters for detecting RNFL defects .
RESULTS	The angular width of RNFL defects was not significantly associated with the sensitivity of macular GCIPL parameters .
CONCLUSIONS	The diagnostic ability of macular GCIPL parameters was comparable to that of peripapillary RNFL and ONH parameters in PPG .
CONCLUSIONS	The inner directional angle of RNFL defects , but not the angular width , affects the diagnostic sensitivity of macular GCIPL parameters .

###24766179
OBJECTIVE	To evaluate the effectiveness of group education , led by health promoters using a guiding style , for people with type 2 diabetes in public sector community health centres in Cape Town .
METHODS	This was a pragmatic clustered randomized controlled trial with 17 randomly selected intervention and 17 control sites .
METHODS	A total of 860 patients with type 2 diabetes , regardless of therapy used , were recruited from the control sites and 710 were recruited from the intervention sites .
METHODS	The control sites offered usual care , while the intervention sites offered a total of four monthly sessions of group diabetes education led by a health promoter .
METHODS	Participants were measured at baseline and 12 months later .
METHODS	Primary outcomes were diabetes self-care activities , 5 % weight loss and a 1 % reduction in HbA ( 1c ) levels .
METHODS	Secondary outcomes were self-efficacy , locus of control , mean blood pressure , mean weight loss , mean waist circumference , mean HbA1c and mean total cholesterol levels and quality of life .
RESULTS	A total of 422 ( 59.4 % ) participants in the intervention group did not attend any education sessions .
RESULTS	No significant improvement was found in any of the primary or secondary outcomes , apart from a significant reduction in mean systolic ( -4.65 mmHg , 95 % CI 9.18 to -0.12 ; P = 0.04 ) and diastolic blood pressure ( -3.30 mmHg , 95 % CI -5.35 to -1.26 ; P = 0.002 ) .
RESULTS	Process evaluation suggested that there were problems with finding suitable space for group education in these under-resourced settings , with patient attendance and with full adoption of a guiding style by the health promoters .
CONCLUSIONS	The reported effectiveness of group diabetes education offered by more highly trained professionals , in well-resourced settings , was not replicated in the present study , although the reduction in participants ' mean blood pressure is likely to be of clinical significance .

###25456370
BACKGROUND	In the EXIST-1 trial , initiated on Aug 10 , 2009 , more than 35 % of patients with subependymal giant cell astrocytoma ( SEGA ) associated with tuberous sclerosis complex had at least 50 % reduction in SEGA volume after 96 months of treatment with everolimus .
BACKGROUND	In this Article , we report interim data ( up to Jan 11 , 2013 ) to support longer-term tolerability and efficacy of everolimus from the continuing 4-year extension phase of EXIST-1 .
METHODS	We assessed data from a prospective , open-label extension of a multicentre , phase 3 , randomised , double-blind , placebo-controlled study in patients with tuberous sclerosis complex who had SEGA that was growing and needed treatment .
METHODS	In this extension study , we included all patients who had been assigned everolimus during the double-blind , randomised phase of the trial and those patients who crossed over from the placebo group to receive everolimus during the randomised phase or at the start of the extension phase .
METHODS	All patients received oral everolimus at a starting dose of 45 mg/m ( 2 ) per day .
METHODS	Everolimus dose was subsequently adjusted subject to tolerability to attain blood trough concentrations of 5-15 ng/mL .
METHODS	An independent central radiology review team assessed SEGA response ( at least a 50 % reduction from baseline in total volume of all target SEGAs ; the primary endpoint ) by MRI at 12 , 24 , and 48 weeks , then every year thereafter in all patients who received at least one dose of everolimus .
METHODS	This study was registered with ClinicalTrials.gov , number NCT00789828 .
RESULTS	Of the original 117 randomly assigned patients , 111 were given everolimus between Aug 20 , 2009 , and Jan 11 , 2013 ( date of data cutoff ) ; we included these patients in our longer-term analysis .
RESULTS	Median duration of everolimus exposure was 293 months ( IQR 194-338 ) .
RESULTS	Median follow-up was 283 months ( IQR 193-330 ) .
RESULTS	54 ( 49 % ) patients had a response of 50 % or greater reduction in SEGA volume ( 95 % CI 390-583 ) , and duration of response was between 21 and 311 months ( median not reached ) .
RESULTS	SEGA volume was reduced by 50 % or more in 39 ( 37 % ) of 105 patients at 24 weeks , 48 ( 46 % ) of 104 patients at 48 weeks , 36 ( 47 % ) of 76 patients at 96 weeks , and 11 ( 38 % ) of 29 patients at 144 weeks .
RESULTS	Stomatitis ( 48 [ 43 % ] patients ) and mouth ulceration ( 33 [ 30 % ] patients ) were the most frequent treatment-related adverse events ; infections were the most commonly reported treatment-related serious adverse event , occurring in 15 ( 14 % ) patients .
RESULTS	35 ( 32 % ) patients reported treatment-related grade 3 or 4 adverse events , the most common of which were stomatitis ( nine [ 8 % ] ) and pneumonia ( nine [ 8 % ] ) .
RESULTS	18 ( 16 % ) patients had treatment-related serious adverse events .
RESULTS	Six ( 5 % ) patients withdrew because of adverse events .
CONCLUSIONS	These results support the longer-term use of everolimus in patients who have few treatment options and who need continued treatment for tuberous sclerosis complex and its varied manifestations .
CONCLUSIONS	Reduction or stabilisation of tumour volume with everolimus will hopefully provide long-term clinical benefit in patients with SEGA .
BACKGROUND	Novartis Pharmaceuticals .

###24517291
OBJECTIVE	Noncontrast computed tomography ( NCCT ) has high sensitivity , specificity , and is able to predict stone composition using Hounsfield units ( HU ) but is associated with high radiation exposure .
OBJECTIVE	In an attempt to reduce radiation exposure , low-dose stone protocols have been developed that provide excellent detection of stones .
OBJECTIVE	It is not known , however , whether these protocols are equally effective in determining HU stone density .
OBJECTIVE	The purpose of this study is to compare stone HU attenuation between low - and conventional-dose NCCT .
METHODS	In this prospective randomized , single blinded study , 7-mm calcium oxalate stones were placed randomly into nine intact urinary systems and scanned in three different cadaveric vehicles .
METHODS	Holding other parameters constant , NCCT was performed at varying mAs levels ranging from 5 to 140 .
METHODS	Identical magnified images at each mAs setting were reviewed in a blinded fashion to determine HU attenuation .
METHODS	Statistical analyses were performed using a Kruskal-Wallis test and the Levene test , with P < 0.05 considered significant .
RESULTS	In 19 different stone configurations with 133 stones , median attenuation levels were 614 , 674 , 681 , 669 , 670 , 674 , and 667 HU at 5 , 7.5 , 15 , 30 , 50 , 70 , and 140 mAs , respectively .
RESULTS	The differences in median attenuation levels were not significantly different ( P = 0.998 ) .
RESULTS	An increasing trend of attenuation variability was noticed as the radiation dose decreased ; however , this was not significant ( P = 1.0 ) .
CONCLUSIONS	Low-dose NCCT results in similar HU attenuation compared with conventional-dose NCCT .
CONCLUSIONS	Although there is a slight increase in variability , low-dose NCCT provides similar information to assist in determining stone composition as conventional-dose NCCT .

###24790277
OBJECTIVE	Rapid eye movement ( REM ) sleep is considered critical to the consolidation of procedural memory - the memory of skills and habits .
OBJECTIVE	Many antidepressants strongly suppress REM sleep , however , and procedural memory consolidation has been shown to be impaired in depressed patients on antidepressant therapy .
OBJECTIVE	As a result , it is important to determine whether antidepressive therapy can lead to amnestic impairment .
OBJECTIVE	We thus investigated the effects of the anticholinergic antidepressant amitriptyline on sleep-dependent memory consolidation .
METHODS	Double-blind , placebo-controlled , randomized , parallel-group study .
METHODS	Sleep laboratory .
METHODS	Twenty-five healthy men ( mean age : 26.8 5.6 y ) .
METHODS	75 mg amitriptyline versus placebo .
RESULTS	To test memory consolidation , a visual discrimination task , a finger-tapping task , the Rey-Osterrieth Complex Figure Test , and the Rey Auditory-Verbal Learning Test were performed .
RESULTS	Sleep was measured using polysomnography .
RESULTS	Our findings show that amitriptyline profoundly suppressed REM sleep and impaired perceptual skill learning , but not motor skill or declarative learning .
CONCLUSIONS	Our study is the first to demonstrate that an antidepressant can affect procedural memory consolidation in healthy subjects .
CONCLUSIONS	Moreover , considering the results of a recent study , in which selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors were shown not to impair procedural memory consolidation , our findings suggest that procedural memory consolidation is not facilitated by the characteristics of REM sleep captured by visual sleep scoring , but rather by the high cholinergic tone associated with REM sleep .
CONCLUSIONS	Our study contributes to the understanding of potentially undesirable behavioral effects of amitriptyline .

###25304725
BACKGROUND	Risk factors for first stroke are well established , but less is known about risk factors for recurrent stroke .
BACKGROUND	In the present analysis , we aimed to assess the effect of heart rate and other possible predictors of stroke in a hypertensive population with previous stroke or transient ischemic attack ( TIA ) .
METHODS	The Valsartan Antihypertensive Long-Term Use Evaluation trial was a multicentre , double-masked , randomized controlled , parallel group trial comparing the effects of an angiotensin receptor blocker ( valsartan ) and a calcium channel blocker ( amlodipine ) in patients with hypertension and high cardiovascular risk .
METHODS	We used Cox proportional hazard models to investigate the effect of baseline variables on the risk of stroke .
METHODS	Quadratic terms of the continuous variables were entered in the models to test for linearity .
RESULTS	Of 15,245 patients included in the trial , 3014 had a previous stroke or TIA at baseline and were included in the present analysis .
RESULTS	Stroke recurrence occurred in 239 patients ( 7.9 % ) during a median of 4.5 years of follow-up .
RESULTS	Resting heart rate ( per 10 beats per minute ; hazard ratio [ HR ] , 2.78 ; 95 % confidence interval [ CI ] , 1.18-6 .58 ) and diabetes mellitus at baseline ( HR , 1.47 ; 95 % CI , 1.03-2 .10 ) were significantly associated with an increased risk of stroke recurrence in the multivariable analysis .
CONCLUSIONS	In high-risk , hypertensive patients with previous stroke or TIA , resting heart rate was the strongest predictor of recurrent stroke .

###25376140
OBJECTIVE	Arthrocentesis ( AC ) is an acceptable treatment modality in the treatment of internal derangement ( ID ) pain .
OBJECTIVE	This study evaluated outcomes of AC on pain relief of ID pain with or without corticosteroids .
METHODS	This single-blind clinical trial was conducted on 60 patients with ID pain who were randomly assigned to 2 groups ( 30 in each group ) for AC .
METHODS	The AC of the upper joint space was then performed by using Ringer lactate under local anesthesia in both groups .
METHODS	In the second group , the procedure was followed by the administration of a single-dose intra-articular dexamethasone ( 8 mg ) .
METHODS	Assessments were made at baseline ( T0 ) , 1 month ( T1 ) , and 6 months ( T6 ) after AC ; pain , maximum mouth opening , and joint sounds before and after treatment up to 6 months were evaluated .
METHODS	Pain severity was documented according to Visual Analogue Scale .
METHODS	Age , sex , and skeletal maxillomandibular relationship were considered as variable factors , and irrigation with or without corticosteroids was a predictive factor of the study .
METHODS	Pain , click , and maximum mouth opening were other assessment outcomes of the study .
RESULTS	Comparison of age , sex , and skeletal relationship did not show any significant differences between the 2 groups .
RESULTS	Results did not demonstrate any difference for click between the 2 groups .
RESULTS	Comparison of pain severity in T0 , T1 , and T2 between the 2 groups did not show any significant differences ( P < 0.05 ) .
RESULTS	The repeat measure test revealed a significant change in T0 , T1 , and T2 for both groups ( P < 0.001 ) .
RESULTS	MMO significantly changed between T0 and T1 and T0 and T6 in the 2 groups without any significant differences between them .
CONCLUSIONS	The AC is an effective procedure for a short-term reduction of pain in temporomandibular disorder cases .
CONCLUSIONS	It seems that AC using Ringer solution with or without corticosteroids may have the same effect on pain relief .

###24711548
OBJECTIVE	Cytogenetically normal ( CN ) acute myeloid leukemia ( AML ) is the largest and most heterogeneous cytogenetic AML subgroup .
OBJECTIVE	For the practicing clinician , it is difficult to summarize the prognostic information of the growing number of clinical and molecular markers .
OBJECTIVE	Our purpose was to develop a widely applicable prognostic model by combining well-established pretreatment patient and disease characteristics .
METHODS	Two prognostic indices for CN-AML ( PINA ) , one regarding overall survival ( OS ; PINAOS ) and the other regarding relapse-free survival ( RFS ; PINARFS ) , were derived from data of 572 patients with CN-AML treated within the AML Cooperative Group 99 study ( www.aml-score.org ) .
RESULTS	On the basis of age ( median , 60 years ; range , 17 to 85 years ) , performance status , WBC count , and mutation status of NPM1 , CEBPA , and FLT3-internal tandem duplication , patients were classified into the following three risk groups according to PINAOS and PINARFS : 29 % of all patients and 32 % of 381 responding patients had low-risk disease ( 5-year OS , 74 % ; 5-year RFS , 55 % ) ; 56 % of all patients and 39 % of responding patients had intermediate-risk disease ( 5-year OS , 28 % ; 5-year RFS , 27 % ) , and 15 % of all patients and 29 % of responding patients had high-risk disease ( 5-year OS , 3 % ; 5-year RFS , 5 % ) , respectively .
RESULTS	PINAOS and PINARFS stratified outcome within European LeukemiaNet genetic groups .
RESULTS	Both indices were confirmed on independent data from Cancer and Leukemia Group B/Alliance trials .
CONCLUSIONS	We have developed and validated , to our knowledge , the first prognostic indices specifically designed for adult patients of all ages with CN-AML that combine well-established molecular and clinical variables and that are easily applicable in routine clinical care .
CONCLUSIONS	The integration of both clinical and molecular markers could provide a basis for individualized patient care through risk-adapted therapy of CN-AML .

###26001033
BACKGROUND	Postoperative apnea is a complication in young infants .
BACKGROUND	Awake regional anesthesia ( RA ) may reduce the risk ; however , the evidence is weak .
BACKGROUND	The General Anesthesia compared to Spinal anesthesia study is a randomized , controlled trial designed to assess the influence of general anesthesia ( GA ) on neurodevelopment .
BACKGROUND	A secondary aim is to compare rates of apnea after anesthesia .
METHODS	Infants aged 60 weeks or younger , postmenstrual age scheduled for inguinal herniorrhaphy , were randomized to RA or GA. .
METHODS	Exclusion criteria included risk factors for adverse neurodevelopmental outcome and infants born less than 26 weeks gestation .
METHODS	The primary outcome of this analysis was any observed apnea up to 12 h postoperatively .
METHODS	Apnea assessment was unblinded .
RESULTS	Three hundred sixty-three patients were assigned to RA and 359 to GA. .
RESULTS	Overall , the incidence of apnea ( 0 to 12 h ) was similar between arms ( 3 % in RA and 4 % in GA arms ; odds ratio [ OR ] , 0.63 ; 95 % CI , 0.31 to 1.30 , P = 0.2133 ) ; however , the incidence of early apnea ( 0 to 30 min ) was lower in the RA arm ( 1 vs. 3 % ; OR , 0.20 ; 95 % CI , 0.05 to 0.91 ; P = 0.0367 ) .
RESULTS	The incidence of late apnea ( 30 min to 12 h ) was 2 % in both RA and GA arms ( OR , 1.17 ; 95 % CI , 0.41 to 3.33 ; P = 0.7688 ) .
RESULTS	The strongest predictor of apnea was prematurity ( OR , 21.87 ; 95 % CI , 4.38 to 109.24 ) , and 96 % of infants with apnea were premature .
CONCLUSIONS	RA in infants undergoing inguinal herniorrhaphy reduces apnea in the early postoperative period .
CONCLUSIONS	Cardiorespiratory monitoring should be used for all ex-premature infants .

###25720930
BACKGROUND	This randomized clinical trial compared endovenous laser ablation ( EVLA ) and surgical ligation with attempted stripping in the treatment of small saphenous vein ( SSV ) insufficiency .
BACKGROUND	The early results demonstrated that EVLA was more likely to eradicate axial reflux and was also associated with a faster recovery , lower periprocedural pain , and fewer sensory complications .
BACKGROUND	The aim of this 2-year follow-up was to establish whether these benefits remained stable over time and whether these improved technical outcomes were associated with less clinical recurrence .
METHODS	Patients with primary saphenopopliteal junction and SSV reflux were randomized to EVLA or saphenopopliteal junction ligation and attempted stripping/excision .
METHODS	Outcomes assessed at 2 years included the presence of residual or recurrent reflux , clinical recurrence , sensory complications , the need for secondary intervention , and patient-reported quality of life on the Aberdeen Varicose Veins Questionnaire , SF-36 , and EuroQol .
RESULTS	Of 106 patients who were equally randomized and successfully treated according to the protocol , 88 ( 83 % ) were successfully assessed at 2 years .
RESULTS	The groups were comparable at baseline .
RESULTS	At 2 years , EVLA remained superior to surgery in eradicating axial reflux in 36 patients ( 81.2 % ) compared with 29 ( 65.9 % ) in the surgery group ( P = .002 ) .
RESULTS	There was no significant difference in clinical recurrence ( EVLA : seven of 44 [ 16 % ] vs surgery : 10 of 44 [ 23 % ] ; P = .736 ) , sensory disturbance ( EVLA : one [ 2.4 % ] vs surgery vs three [ 6.8 % ] ; P = 1.000 ) or any quality of life domain .
CONCLUSIONS	The results of treatment of SSV insufficiency with EVLA appear durable up until 2 years .
CONCLUSIONS	The study does not appear to suggest that the improved abolition of reflux after EVLA compared with surgery is associated with superior outcomes than those seen after surgery by this time point , because equal effect was shown in both groups .
CONCLUSIONS	The sensory disturbance associated with surgery appears to settle over this time frame .
CONCLUSIONS	EVLA is therefore superior in the short-term and not inferior by 2 years .

###24976452
BACKGROUND	Neutralizing antibodies in breast milk may adversely influence the immune response to live oral vaccines .
BACKGROUND	Withholding breastfeeding around the time of vaccine administration has been suggested for improving vaccine performance .
BACKGROUND	However , we do not know whether mothers find withholding breastfeeding around the time of vaccination acceptable and how they perceive this recommendation .
METHODS	In a clinical study designed to examine predictors of poor immune response to rotavirus vaccine in infants in India , Rotarix was administered to infants at 6 and 10 weeks with other childhood vaccines .
METHODS	For the study , 400 mother-infant pairs were randomized into two groups in a 1:1 ratio .
METHODS	Mothers were either recommended to withhold breastfeeding or were encouraged to breastfeed half an hour before and after administration of Rotarix .
METHODS	The mother-infant pairs were observed and the breastfeeding intervals were recorded during this period .
METHODS	Mothers were administered a questionnaire about their perception of the intervention after the infants received the second dose of Rotarix .
RESULTS	Almost 98 % ( 391/400 ) of the infants received both doses of Rotarix .
RESULTS	Adherence to the recommendations was high in both groups .
RESULTS	All mothers in the group who were asked to withhold breastfeeding did so , except one who breastfed her infant before the recommended time after the first dose of Rotarix .
RESULTS	Of the mothers , 4 % ( 7/195 ) reported that the recommendation to withhold breastfeeding was difficult to follow .
RESULTS	All mothers in this group reported that they would withhold breastfeeding at the time of vaccination if they were asked to by a health-care provider .
RESULTS	Only one mother responded that withholding breastfeeding would be a reason for not giving rotavirus vaccine to her infant .
CONCLUSIONS	Withholding breastfeeding half an hour before and after vaccination appears to be acceptable to mothers in this setting .
CONCLUSIONS	If withholding breastfeeding produces an improvement in the performance of the vaccine , it could be used to increase the public health impact of rotavirus immunization .
BACKGROUND	Clinical Trial Registry , India ( CTRI/2012/10 / 003057 ) , Clinicaltrials.gov ( NCT01700127 ) .
BACKGROUND	Date of Registration : Clinical Trial Registry , India : 28 September 2012 , Clinicaltrials.gov : 3 October 2012 .

###25822691
OBJECTIVE	The aim of the study was to determine whether individualized coaching improved surgical technical skill in the operating room to a higher degree than current residency training .
BACKGROUND	Clinical training in the operating room is a valuable opportunity for surgeons to acquire skill and knowledge ; however , it often remains underutilized .
BACKGROUND	Coaching has been successfully used in various industries to enhance performance , but its role in surgery has been insufficiently investigated .
METHODS	This randomized controlled trial was conducted at one surgical training program .
METHODS	Trainees undergoing a minimally invasive surgery rotation were randomized to either conventional training ( CT ) or comprehensive surgical coaching ( CSC ) .
METHODS	CT included ward and operating room duties , and regular departmental teaching sessions .
METHODS	CSC comprised performance analysis , debriefing , feedback , and behavior modeling .
METHODS	Primary outcome measures were technical performance as measured on global and procedure-specific rating scales , and surgical safety parameters , measured by error count .
METHODS	Operative performance was assessed by blinded video analysis of the first and last cases recorded by the participants during their rotation .
RESULTS	Twenty residents were randomized and 18 completed the study .
RESULTS	At posttraining the CSC group ( n = 9 ) scored significantly higher on a procedure-specific skill scale compared with the CT group ( n = 9 ) [ median , 3.90 ( interquartile range , 3.68-4 .30 ) vs 3.60 ( 2.98-3 .70 ) , P = 0.017 ] , and made fewer technical errors [ 10 ( 7-13 ) vs 18 ( 13-21 ) , P = 0.003 ] .
RESULTS	Significant within-group improvements for all skill metrics were only noted in the CSC group .
CONCLUSIONS	Comprehensive surgical coaching enhances surgical training and results in skill acquisition superior to conventional training .

###24481893
OBJECTIVE	To compare and contrast three different training modalities for fit testing N-95 respirator face masks .
METHODS	Block randomized interventional study .
METHODS	Urban university .
METHODS	Two hundred eighty-nine medical students .
METHODS	Students were randomly assigned to video , lecture , or slide show to evaluate the effectiveness of the methods for fit testing large groups of people .
METHODS	Ease of fit and success of fit for each instructional technique .
RESULTS	Mask 1 was a Kimberly-Clark duckbill N-95 respirator mask , and mask 2 was a 3M carpenters N-95 respirator mask .
RESULTS	`` Ease of fit '' was defined as the ability to successfully don a mask in less than 30 seconds .
RESULTS	`` Success of fit '' was defined as the ability to correctly don a mask in one try .
RESULTS	There were no statistical differences by training modality for either mask regarding ease of fit or success of fit .
CONCLUSIONS	There were no differences among video presentation , small group demonstration , and self-directed slide show just-in-time training modalities for ease of fit or success of fit N-95 respirator mask fitting .
CONCLUSIONS	Further study is needed to explore more effective fit training modalities .

###25025610
BACKGROUND	In TRITON-TIMI 38 , patients with acute coronary syndromes were treated with prasugrel or clopidogrel , with aspirin , for a median of 14.5 ( maximum of 15 ) months .
BACKGROUND	Based on this trial , the EU label for prasugrel recommends treatment for up to 12 months and excludes patients with prior stroke/transient ischemic attack ( TIA ) .
BACKGROUND	Furthermore , the EU label recommends the 10mg maintenance dose ( MD ) for patients with body weight 60kg and age < 75 years .
BACKGROUND	A lower MD of 5mg is recommended for those with body weight < 60kg ; although generally not recommended , 5mg can be prescribed to patients 75 years after individual risk-benefit evaluation .
BACKGROUND	This paper presents the one-year outcome data for this ' 10mg indicated cohort ' .
RESULTS	From the overall cohort of 13,608 patients in TRITON-TIMI 38 , 10,804 fulfilled inclusion criteria for the 10mg indicated cohort , of whom 22 % had a history of diabetes , 73 % an index diagnosis of unstable angina/non-ST-segment - elevation myocardial infarction ( UA/NSTEMI ) , and 27 % an index diagnosis of ST-segment-elevation myocardial infarction ( STEMI ) .
RESULTS	In this cohort at 12 months , those given prasugrel experienced significantly fewer ischemic events ( cardiovascular death , non-fatal myocardial infarction , or non-fatal stroke , 7.8 % vs 10.5 % , hazard ratio ( HR ) = 0.73 , p < 0.001 , than those given clopidogrel , with a non-significant increase in non-coronary artery bypass graft ( CABG ) TIMI major bleeding , 1.7 % vs 1.5 % , HR = 1.15 , p = 0.40 ; similarly , in the overall cohort these frequencies were 9.4 % vs 11.4 % , HR = 0.81 , p < 0.001 , for cardiovascular death , non-fatal myocardial infarction , or non-fatal stroke , and 2.2 % vs 1.8 % , HR = 1.24 , p = 0.10 , for non-CABG TIMI major bleeding .
RESULTS	There was a significant reduction in stent thrombosis in the prasugrel group , with similar mortality rates and no excess of strokes .
CONCLUSIONS	Treatment with prasugrel according to EU label recommendations results in a significant 27 % and 57 % relative risk reduction ( absolute risk reductions of 2.7 % and 1.2 % ) in ischemic events and stent thromboses respectively compared with clopidogrel , with a 15 % relative risk increase ( absolute risk increase of 0.2 % ) for major bleeds ( p = 0.40 ) , and no excess of strokes .
CONCLUSIONS	Although restricted to 365 days of follow-up , this analysis encapsulates 1366 of 1424 ( 95.9 % ) of all primary endpoint events and 244 of 257 ( 94.9 % ) of all first non-CABG TIMI major bleeds reported in the pivotal manuscript .
CONCLUSIONS	Furthermore , the 10mg indicated cohort was not a pre-specified subgroup in the study protocol , but due to European labeling restrictions , results for all outcomes in this cohort are presented through 12 months .

###24708781
BACKGROUND	The aim of this study was to evaluate the usefulness of the APACHE II ( Acute Physiology and Chronic Health Evaluation II ) , SAPS II ( Simplified Acute Physiology Score II ) and SOFA ( Sequential Organ Failure Assessment ) scores compared to simpler models based on age and Glasgow Coma Scale ( GCS ) in predicting long-term outcome of patients with moderate-to-severe traumatic brain injury ( TBI ) treated in the intensive care unit ( ICU ) .
METHODS	A national ICU database was screened for eligible TBI patients ( age over 15 years , GCS 3-13 ) admitted in 2003-2012 .
METHODS	Logistic regression was used for customization of APACHE II , SAPS II and SOFA score-based models for six-month mortality prediction .
METHODS	These models were compared to an adjusted SOFA-based model ( including age ) and a reference model ( age and GCS ) .
METHODS	Internal validation was performed by a randomized split-sample technique .
METHODS	Prognostic performance was determined by assessing discrimination , calibration and precision .
RESULTS	In total , 1,625 patients were included .
RESULTS	The overall six-month mortality was 33 % .
RESULTS	The APACHE II and SAPS II-based models showed good discrimination ( area under the curve ( AUC ) 0.79 , 95 % confidence interval ( CI ) 0.75 to 0.82 ; and 0.80 , 95 % CI 0.77 to 0.83 , respectively ) , calibration ( P > 0.05 ) and precision ( Brier score 0.166 to 0.167 ) .
RESULTS	The SOFA-based model showed poor discrimination ( AUC 0.68 , 95 % CI 0.64 to 0.72 ) and precision ( Brier score 0.201 ) but good calibration ( P > 0.05 ) .
RESULTS	The AUC of the SOFA-based model was significantly improved after the insertion of age and GCS ( AUC +0.11 , P < 0.001 ) .
RESULTS	The performance of the reference model was comparable to the APACHE II and SAPS II in terms of discrimination ( AUC 0.77 ; compared to APACHE II , AUC -0.02 , P = 0.425 ; compared to SAPS II , AUC -0.03 , P = 0.218 ) , calibration ( P > 0.05 ) and precision ( Brier score 0.181 ) .
CONCLUSIONS	A simple prognostic model , based only on age and GCS , displayed a fairly good prognostic performance in predicting six-month mortality of ICU-treated patients with TBI .
CONCLUSIONS	The use of the more complex scoring systems APACHE II , SAPS II and SOFA added little to the prognostic performance .

###25490958
BACKGROUND	Pomaglumetad methionil ( LY2140023 monohydrate ) is a potent and highly selective agonist for the metabotropic glutamate mGluR2 and mGluR3 receptors .
BACKGROUND	We present results of a pivotal clinical study H8Y-MC-HBBM assessing the efficacy of LY2140023 in improving symptoms as a monotherapy in patients with an acute exacerbation of schizophrenia .
METHODS	Enrolled adult patients ( ages 18-65 ) with schizophrenia who had experienced an exacerbation of symptoms within 2 weeks prior to study entry .
METHODS	Patients ( N = 1013 ) were randomized 2:2:2:1 to treatment with placebo , LY40 mg twice daily ( BID ) , LY80 mg BID , or risperidone ( RIS ) 2 mg BID for 6 weeks after a one-week blinded placebo lead-in .
METHODS	The primary outcome assessed change from baseline in the Positive and Negative Syndrome Scale ( PANSS ) total score in an overall schizophrenia population and a predefined subpopulation which excluded non-Hispanic white patients with the A/A genotype at the HTR2A SNP rs7330461 .
RESULTS	Neither LY2140023 dose showed significant improvement compared to placebo on PANSS total in either population ( 1-sided p-value [ significance level ] , overall : LY40 , p = .154 [ 0.01 ] ; LY80 , p = .698 [ 0.01 ] , subpopulation : LY40 , p = .033 [ 0.0025 ] ; LY80 , p = .659 [ 0.0025 ] , MMRM analysis ) .
RESULTS	RIS statistically separated from placebo in both populations ( p < .001 [ 0.05 ] ) .
RESULTS	There were no statistically significant differences in the incidence of serious adverse events , and no seizures on LY2140023 .
CONCLUSIONS	LY2140023 treatment did not demonstrate efficacy in populations studied .
CONCLUSIONS	Overall , LY2140023 treatment was generally well tolerated with no new adverse safety findings compared to previous trials .
CONCLUSIONS	Further understanding of the role of glutamate as a therapeutic target in schizophrenia is needed .
BACKGROUND	A Phase 2 , Multicenter , Double-Blind , Placebo-Controlled Comparator Study of 2 Doses of LY2140023 Versus Placebo in Patients With DSM-IV-TR Schizophrenia ClinicalTrials.gov identifier : NCT01086748 .

###25218397
BACKGROUND	The aim of the present study was to investigate the effects of mindfulness-based cognitive therapy ( MBCT ) on suicidal ideation in an open-label randomised controlled trial of patients with residual depressive symptoms .
BACKGROUND	Furthermore , this study aimed at examining whether an effect of MBCT on suicidal ideation was dependent on a reduction in depression severity , worry and rumination , or an increase in mindfulness .
METHODS	One hundred and thirty participants were randomised to a treatment arm ( treatment as usual plus MBCT ) or a wait list arm .
METHODS	Change in depression , change in worry , change in rumination and change in mindfulness were entered as covariates in a repeated measures ANOVA in order to assess to what degree MBCT-induced changes in suicidal ideation were independent from changes in these parameters .
RESULTS	There was a significant grouptime ( pre vs. post ) interaction on suicidal ideation indicating a significant reduction of suicidal ideation in the MBCT group , but not in the control group .
RESULTS	The interaction remained significant after addition of the above covariates .
RESULTS	Change in worry was the only covariate associated with change in suicidal ideation , causing a moderate reduction in the interaction effect size .
CONCLUSIONS	The results suggest that MBCT may affect suicidal ideation in patients with residual depressive symptoms and that this effect may be mediated , in part , by participants ' enhanced capacity to distance themselves from worrying thoughts .

###25380894
BACKGROUND	The aim of this study was to show the preliminary outcomes of transplantation in patients treated with the generic formulation of mycophenolate mofetil ( Myfenax , Teva ) .
METHODS	Over the past 4 years , 60 patients received generic mycophenolate mofetil ( Myfenax ) after renal transplantation at the Gdansk Transplantology Center .
METHODS	During the same time period , another 273 kidney transplantations were performed in our department , and these patients were treated with other formulations of mycophenolate ( CellCept [ Roche ] , Myfortic , or mycophenolate mofetil-Apotex ) as a part of the immunosuppressive plan .
METHODS	Thirty of the Myfenax patients received a pair of kidneys from the same donor and received original mycophenolate mofetil CellCept with observation for at least 12 months .
RESULTS	The outcomes of the renal transplantations in both groups ( Myfenax vs pair ) were good , with satisfactory function of grafts .
RESULTS	One case of graft loss was reported in the Myfenax group ( renal vein thrombosis , graftectomy 5 days after transplantation ) .
RESULTS	There was no difference in the incidence of acute renal graft rejection in either group .
RESULTS	Moderate adverse reactions to immunosuppression were observed in both groups .
RESULTS	On the other hand , a comparison between the 60 patients with Myfenax and the 273 other patients with other formulations of mycophenolate revealed no differences in the incidence of acute renal graft rejection , delayed graft function , graft loss , and death .
CONCLUSIONS	There were no differences in the incidence of acute renal graft rejection , delayed graft function , graft loss , and death in patients with Myfenax vs original CellCept and other formulations of mycophenolate .
CONCLUSIONS	To confirm its complete biological and pharmacokinetic equivalence with the reference medicine , long-term , randomized observations carried out on larger renal transplant patients groups are needed .

###24748637
OBJECTIVE	To determine whether children with calcium-deficiency rickets have a better response to treatment with vitamin D and calcium than with calcium alone .
METHODS	Randomised controlled trial .
METHODS	Jos University Teaching Hospital , Jos , Nigeria .
METHODS	Nigerian children with active rickets treated with calcium carbonate as limestone ( approximately 938 mg elemental calcium twice daily ) were , in addition , randomised to receive either oral vitamin D2 50,000 IU ( Ca + D , n = 44 ) or placebo ( Ca , n = 28 ) monthly for 24weeks .
METHODS	Achievement of a 10-point radiographic severity score 1.5 and serum alkaline phosphatase 350U/L .
RESULTS	The median ( range ) age of enrolled children was 46 ( 15-102 ) months , and baseline characteristics were similar in the two groups .
RESULTS	Mean ( SD ) 25-hydroxyvitamin D ( 25 ( OH ) D ) was 30.213.2 nmol/L at baseline , and 29 ( 43 % ) had values < 30nmol/L .
RESULTS	Baseline alkaline phosphatase and radiographic scores were unrelated to vitamin D status .
RESULTS	Of the 68 children ( 94 % of original cohort ) who completed 24weeks of treatment , 29 ( 67 % ) in the Ca + D group and 11 ( 44 % ) in the Ca group achieved the primary outcome ( p = 0.06 ) .
RESULTS	Baseline 25 ( OH ) D did not alter treatment group effects ( p = 0.99 for interaction ) .
RESULTS	At the end of 24weeks , 25 ( OH ) D values were 55.417.0 nmol/L and 37.920.0 nmol/L in the Ca + D and Ca groups , respectively , ( p < 0.001 ) .
RESULTS	In the Ca + D and Ca groups , the final 25 ( OH ) D concentration was greater in those who achieved the primary outcome ( 56.417.2 nmol/L ) than in those who did not ( 37.718.5 nmol/L , p < 0.001 ) .
CONCLUSIONS	In children with calcium-deficiency rickets , there is a trend for vitamin D to improve the response to treatment with calcium carbonate as limestone , independent of baseline 25 ( OH ) D concentrations .
BACKGROUND	ClinicalTrials.gov NCT00949832 .

###24831918
BACKGROUND	Patient-reported outcomes are increasingly incorporated in drug evaluation trials .
BACKGROUND	Whether new immunosuppressive drugs result in an improved health-related quality of life ( HRQoL ) and a reduced side effect experiences remains unknown .
BACKGROUND	Moreover , the relationship between HRQoL and kidney function has never been investigated in kidney transplant recipients .
METHODS	Using the BENEFIT and BENEFIT-EXT trials , we investigated the following : ( a ) evolution of HRQoL , assessed by the Medical Outcomes Short Form Health Survey ( SF-36 ) in the first 3 years ( baseline , 12 , 24 , and 36 months ) after kidney transplantation ; ( b ) association among kidney function ( chronic kidney disease stage ) , HRQoL , and patient-reported side effects ( Modified Transplant Symptom Occurrence and Symptom Distress Scale-59R ; BENEFIT trial only ) ; and ( c ) impact of belatacept and cyclosporine on side effect experience and HRQoL .
RESULTS	In the BENEFIT trial , all subjects reported clinically meaningful improvements compared with baseline and returned to general population scores , both for physical composite score ( PCS ) and mental composite score Short Form ( 36 ) Health Survey at 12 to 36 months after transplantation .
RESULTS	In the BENEFIT-EXT trial , this was observed for PCS only .
RESULTS	Belatacept-treated patients reported better absolute PCSs compared with cyclosporine-treated patients .
RESULTS	The differences were small but statistically significant at all times .
RESULTS	Belatacept-treated patients tended to experience less side effects compared with cyclosporine-treated patients , except for dry skin .
RESULTS	Worsening kidney function was associated with a significant decrease in HRQoL .
CONCLUSIONS	Worsening in kidney function was associated with lower HRQoL .
CONCLUSIONS	Compared with cyclosporine , belatacept was associated with improved HRQoL , suggesting that use of non-nephrotoxic immunosuppressants may affect the patient 's side effect experience and improve their HRQoL .

###24350692
OBJECTIVE	To examine the impact of prescription on predicted speech intelligibility and loudness for children .
METHODS	A between-group comparison of speech intelligibility index ( SII ) and loudness , based on hearing aids fitted according to NAL-NL1 , DSL v4 .1 , or DSL m [ i/o ] prescriptions .
METHODS	A within-group comparison of gains prescribed by DSL m [ i/o ] and NAL-NL2 for children in terms of SII and loudness .
METHODS	Participants were 200 children , who were randomly assigned to first hearing-aid fitting with either NAL-NL1 , DSL v4 .1 , or DSL m [ i/o ] .
METHODS	Audiometric data and hearing-aid data at 3 years of age were used .
RESULTS	On average , SII calculated on the basis of hearing-aid gains were higher for DSL than for NAL-NL1 at low input level , equivalent at medium input level , and higher for NAL-NL1 than DSL at high input level .
RESULTS	Greater loudness was associated with DSL than with NAL-NL1 , across a range of input levels .
RESULTS	Comparing NAL-NL2 and DSL m [ i/o ] target gains revealed higher SII for the latter at low input level .
RESULTS	SII was higher for NAL-NL2 than for DSL m [ i/o ] at medium - and high-input levels despite greater loudness for gains prescribed by DSL m [ i/o ] than by NAL-NL2 .
CONCLUSIONS	The choice of prescription has minimal effects on speech intelligibility predictions but marked effects on loudness predictions .

###24693988
BACKGROUND	Femorotibial knee osteoarthritis is associated with muscle weakness in the lower limbs , particularly in the quadriceps , which results in disease progression .
BACKGROUND	The interest of having muscular strengthening as part of the therapeutic arsenal for the medical treatment of knee osteoarthritis is now well established.The functional disability induced by knee osteoarthritis manifests itself principally when walking , notably downhill , during which the muscles are called upon to contract eccentrically.We can therefore think that eccentric muscular strengthening could bring a functional benefit that is superior to concentric muscular strengthening .
METHODS	This is a prospective , randomized , bicenter , parallel-group , international study .
METHODS	Eighty patients aged from 40 to 75 years old , suffering from medical-stage knee osteoarthritis , will undertake 6 weeks of isokinetic muscular strengthening .
METHODS	Randomization determines the mode of muscular strengthening : either exclusively eccentric or exclusively concentric.The principal objective is to demonstrate the superiority of the improvement in the quadriceps isokinetic torque after isokinetic muscular strengthening by the eccentric mode compared to the concentric mode.The following parameters are also evaluated : the variations in the level of pain , the parameters of walking ( maximum speed over 10 and 200 meters , analysis on a computerized Gaitrite treadmill ) , static equilibrium ( on a FUSYO force platform ) , and the functional status of the patient using the Western Ontario and MacMaster Universities osteoarthritis index ( WOMAC ) questionnaire after the strengthening period and at 6 months .
CONCLUSIONS	A better knowledge of the most effective mode of muscular strengthening is needed to optimize the functional benefits to the patients .
CONCLUSIONS	In case of superiority in terms of efficacy of the eccentric mode , the latter could be given priority in the rehabilitation treatment of knee osteoarthritis patients .
BACKGROUND	Clinical trials.gov number : NCT01586130 .

###25052844
BACKGROUND	We developed the iTrainer ( iT ) as a portable laparoscopic trainer , which incorporates the iPad tablet .
BACKGROUND	We then compared the iT with a standard pelvic trainer ( SPT ) to assess surgical skills as well as its image quality , resolution , brightness , comfort , and overall performance .
METHODS	We designed and constructed the iT to be compatible with the Apple iPad 3 and standard laparoscopic instruments .
METHODS	Participants were assigned to perform the thread-the-loops task on both trainers and were prospectively randomized to start on either the iT or the SPT .
METHODS	Each participant was allowed a 2-minute warm-up before the 2-minute testing period .
METHODS	We scored participants using the product of skill quality ( 0-4 scale ) and quantity of loops threaded ( 0-10 scale ) .
METHODS	Participants then rated each trainer on image quality , resolution , brightness , comfort , and overall performance on a 5-point Likert scale .
RESULTS	A total of 45 subjects including 10 undergraduates , 10 medical students , 10 general surgery and urology residents , and 15 experts ( fellows and attending surgeons ) participated in this study .
RESULTS	There was no significant difference between thread-the-loops task scores completed on the iT when compared with the SPT for all groups tested ( p > 0.05 ) with the exception of the medical student group , who performed better on the SPT ( p < 0.05 ) .
RESULTS	On evaluation of each trainer , participants rated the iT as having superior image quality and resolution when compared with the SPT ( p < 0.05 ) but rated the SPT higher in overall performance ( p < 0.05 ) .
RESULTS	Brightness and comfort were rated similarly for both trainers .
CONCLUSIONS	We have demonstrated face validity and criterion validity for the thread-the-loops task on the iT .
CONCLUSIONS	The iT rated superior in image quality and resolution but inferior in overall performance compared with the SPT .
CONCLUSIONS	The iT provides trainees a unique advantage over SPT as an additional resource to laparoscopic training as it is inexpensive , portable , and can be readily available for training .

###24479254
BACKGROUND	Simulator sickness causes vestibulo-autonomic responses that increase sympathetic activity and decrease parasympathetic activity .
BACKGROUND	The purpose of the study was to quantify these responses through electrogastrography and cardiac interbeat intervals during flight simulation .
METHODS	There were 29 subjects that were randomly assigned to 2 parallel arms : ( 1 ) oculovestibular recoupling , where galvanic vestibular stimulation was synchronous with the visual field ; and ( 2 ) control .
METHODS	Electrogastrography and interbeat interval data were collected during baseline , simulation , and post-simulation periods .
METHODS	A simulator sickness questionnaire was administered .
RESULTS	Statistically significant differences were observed in percentage of recording time with the dominant frequency of electrogastrography in normogastric and bradygastric domains between the oculovestibular recoupling and control groups .
RESULTS	Normogastria was dominant during simulation in the oculovestibular recoupling group .
RESULTS	In the control group , the percentage of recording time with the dominant frequency decreased by 22 % in normogastria and increased by 20 % in bradygastria .
RESULTS	The percentage change of the dominant power instability coefficient from baseline to simulation was 26 % in the oculovestibular recoupling group vs. 108 % in the control group .
RESULTS	The power of high-frequency components for interbeat intervals did not change significantly in the oculovestibular recoupling group and was decreased during simulation in the control group .
CONCLUSIONS	Electrogastrography and interbeat intervals are sensitive indices of autonomic changes in subjects undergoing flight simulation .
CONCLUSIONS	These data demonstrate the potential of oculovestibular recoupling to stabilize gastric activity and cardiac autonomic changes altered during simulator and motion sickness .

###24507659
BACKGROUND	The inability of current vaccines to provide effective protection against porcine reproductive and respiratory syndrome virus ( PRRSV ) infection is not fully understood .
BACKGROUND	One of the reasons might be the presence of anti-idiotypic antibodies ( Ab2s ) to the envelope glycoprotein GP5 induced by PRRSV infection since our previous studies demonstrated the presence of auto-Ab2s ( aAb2s ) in pigs infected with PRRSV .
BACKGROUND	To test this hypothesis , PRRSV negative piglets were injected with a monoclonal Ab2 ( Mab2-5G2 ) and aAb2s that are specific for anti-GP5 antibody , vaccinated with the attenuated PRRSV vaccine CH-1R and then challenged with the highly pathogenic PRRSV HuN4 strain .
BACKGROUND	The animals were evaluated for clinical signs , pathological changes of the thymus and lungs , viremia , levels of serum antibodies and cytokines .
RESULTS	The piglets injected with Mab2-5G2 or aAb2 , and who received the attenuated PRRSV vaccine CH-1R before challenge , produced high levels of anti-N antibodies , IL-2 and IL-4 , but low levels of neutralizing antibodies .
RESULTS	After PRRSV HuN4 challenge , the animals showed obvious clinical signs , including lung lesions , severe thymus atrophy and decreased production of IL-4 and higher level of viremia .
CONCLUSIONS	When anti-GP5 Ab2s are present , the use of attenuated PRRSV vaccine CH-1R against HP-PRRSV infection is not recommended .
CONCLUSIONS	It can result in poor health status with pneumonia and thymus atrophy .

###26062881
BACKGROUND	Problems associated with lifelong antiretroviral therapy , such as need for strict adherence , drug-related toxic effects , difficulties with treatment schedules , and cost , mean that simplification strategies should be sought .
BACKGROUND	We aimed to explore the efficacy and safety of dual treatment with atazanavir-ritonavir plus lamivudine as an option to switch to from standard combination antiretroviral therapy in patients with an HIV-1 infection who are virologically suppressed .
METHODS	In this randomised , open-label , non-inferiority trial , we recruited patients aged 18 years and older with chronic HIV-1 infection and no previous treatment failure or resistance , and with HIV-1 RNA of less than 50 copies per mL for at least 6 months , negative hepatitis B virus surface antigen , and good general health , from 30 hospitals in Spain .
METHODS	Exclusion criteria were switch in antiretroviral therapy during the previous 4 months , previous virological failure , pregnancy or breastfeeding , Gilbert 's syndrome , use of contraindicated drugs , grade 4 laboratory abnormalities , and previous intolerance to any of the study drugs .
METHODS	We randomly assigned patients ( 1:1 ; stratified by active hepatitis C virus infection and previous treatment ; computer-generated random number sequence ) to dual treatment with oral atazanavir ( 300 mg once daily ) and ritonavir ( 100 mg once daily ) plus lamivudine ( 300 mg once daily ) or triple treatment with oral atazanavir ( 300 mg once daily ) and ritonavir ( 100 mg once daily ) plus two nucleos ( t ) ide reverse transcriptase inhibitors at the discretion of the investigators .
METHODS	The primary endpoint was virological response , defined as HIV-1 RNA of less than 50 copies per mL at week 48 , in the per-protocol population , with a non-inferiority margin of 12 % .
METHODS	We included patients who received at least one dose of the study drug in the safety analysis .
METHODS	This study is registered at ClinicalTrials.gov , number NCT01307488 .
RESULTS	Between Sept 29 , 2011 , and May 2 , 2013 , we randomly assigned 286 patients ( 143 [ 50 % ] to each group ) .
RESULTS	At week 48 in the per-protocol population , 112 ( 84 % ) of 133 patients had virological response in the dual-treatment group versus 105 ( 78 % ) of 135 in the triple-treatment group ( difference 6 % [ 95 % CI -5 to 16 % ) , showing non-inferiority at the prespecified level .
RESULTS	14 ( 5 % ) patients developed severe adverse events ( dual treatment six [ 4 % ] ; triple treatment eight [ 6 % ] ) , none of which we deemed related to the study drug .
RESULTS	Grade 3-4 adverse events were similar between groups ( dual treatment 77 [ 55 % ] of 140 ; triple treatment 78 [ 55 % ] of 141 ) .
RESULTS	Treatment discontinuations were less frequent in the dual-treatment group ( three [ 2 % ] ) than in the triple-treatment group ( ten [ 7 % ] ; p = 0047 ) .
CONCLUSIONS	In our trial , dual treatment was effective , safe , and non-inferior to triple treatment in patients with an HIV-1 infection who are virologically suppressed who switch antiretroviral therapy because of toxic effects , intolerance , or simplification .
CONCLUSIONS	This combination has the potential to suppress some of the long-term toxic effects associated with nucleos ( t ) ide reverse transcriptase inhibitors , preserve future treatment options , and reduce the cost of antiretroviral therapy .
BACKGROUND	Bristol Myers-Squibb and Fundacin SEIMC-GESIDA .

###24521887
OBJECTIVE	To observe the efficacy of Jinghuaweikang gelatin pearls plus proton pump inhibitor ( PPI ) - based triple regimen in the treatment of chronic atrophic gastritis ( CAG ) patients with Helicobacter pylori ( H.pylori ) infection .
METHODS	For this multicenter , randomized , controlled clinical study , 90 patients of endoscopically confirmed CAG with positive H.pylori ( ( 13 ) C or ( 14 ) C-urea breath test ( UBT ) or rapid urease test ) were enrolled .
METHODS	There were 46 males and 44 females with an age range of ( 54 10 ) years .
METHODS	None of them had H.pylori eradication background .
METHODS	They were randomly divided into 2 groups , Group LACJ ( n = 45 ) received lansoprazole 30 mg + amoxicillin 1000 mg + clarithromycin 500 mg + jinghuaweikang gelatin pearls 240 mg , twice daily , for 10 days ( d1-10 ) plus another 14 days ( d11-24 ) only with jinghuaweikang gelatin pearls 240 mg , twice daily .
METHODS	Group LACB ( n = 45 ) had standard quadruple regimen treatment : lansoprazole 30 mg + amoxicillin 1000 mg + clarithromycin 500 mg + bismuth potassium citrate 220 mg , twice daily for 10 days ( d1-10 ) .
METHODS	The status of H.pylori was detected by ( 13 ) C-UBT at least 28 days after therapy .
RESULTS	The eradication rates in Groups LACJ and LACB were as follows : per-protocol ( PP ) : 70.5 % ( 31/44 ) and 83.3 % ( 35/42 ) , intention-to-treat ( ITT ) : 68.9 % ( 31/45 ) and 77.8 % ( 35/45 ) ( both P > 0.05 ) .
RESULTS	The symptomatic improvements of bloating in upper abdomen , belching and epigastric pain after treatment in both groups .
RESULTS	And those in Group LACJ was higher than those of Group LACB , but no statistical difference existed between two groups ( all P > 0.05 ) .
CONCLUSIONS	The efficacy of LACJ for the treatment of CAG patients with H.pylori infection is similar to LACB .
CONCLUSIONS	And the symptomatic improvement of patients is better than LACB .

###25901477
OBJECTIVE	To determine the independent and combined effects of pain and opioids on the activation of an early marker of inflammation , nuclear factor-B ( NF-B ) .
METHODS	NF-B activation was compared within-subjects following four randomly ordered experimental sessions of opioid-only ( intravenous fentanyl 1 g/kg ) , painonly ( cold-pressor ) , opioid + pain , and a resting condition .
METHODS	University General Clinical Research Center .
METHODS	Twenty-one ( 11 female ) healthy controls .
METHODS	Following exposure to treatment ( fentanyl administration and/or cold-pressor pain ) , blood samples for NF-B analysis were obtained .
METHODS	Intracellular levels of activated NF-B , in unstimulated and stimulated peripheral blood mononuclear cells at 15 and 30 minutes .
RESULTS	Neither pain nor opioid administration alone effected NF-B levels in cell populations ; however , the combination of treatments induced significant increases of NF-B in stimulated peripheral blood mononuclear cell , lymphocytes , and monocytes .
CONCLUSIONS	The combination of acute pain with opioids , as occurs in clinical situations , activates a key transcription factor involved in proinflammatory responses .

###25326008
BACKGROUND	Hemodynamic disturbances are common during continuous epidural anesthesia in elderly patients undergoing total hip arthroplasty .
BACKGROUND	This study aimed to investigate the effects of methoxamine on the intraoperative hemodynamics in elderly patients undergoing total hip arthroplasty under epidural anesthesia .
METHODS	This prospective study included 150 elderly patients undergoing elective total hip arthroplasty under epidural anesthesia .
METHODS	Patients were randomly assigned into 5 groups ( n = 30 per group ) : a control group receiving saline ( Group C ) , a dopamine group receiving 7 g/kg/min dopamine ( Group D ) , and methoxamine groups receiving 1 , 2 , or 3 g/kg/min methoxamine ( Groups M1 , M2 , and M3 , respectively ) .
METHODS	Hemodynamic parameters were assessed 10 min before anesthesia ( T1 ) ; 10 min ( T2 ) , 20 min , ( T3 ) , 30 min ( T4 ) , and 60 min ( T5 ) after anesthesia ; and at the conclusion of surgery ( T6 ) .
RESULTS	At T2-T6 , the mean arterial pressure , central venous pressure , cardiac output , stroke volume , stroke volume ratio , and pulmonary vascular resistance were higher in Groups D , M2 , and M3 compared to Group C ( p < 0.05 ) .
RESULTS	Compared to Group D , the heart rate and rate pressure product were significantly lower in Groups M1-M3 .
RESULTS	Infusion volume , ephedrine dose , and postoperative 24-h urine volume were significantly lower and intraoperative urine volume was significantly greater in Groups D , M2 , and M3 compared with Group C. Hypertension occurred more frequently in Group M3 than in any other group .
CONCLUSIONS	Continuous intravenous infusion of 2 g/kg/min methoxamine is safe and effective in maintaining hemodynamic stability in elderly patients undergoing total hip arthroplasty .

###24313633
OBJECTIVE	This study aimed at evaluating the safety and efficacy of an improved dosage regimen of sertraline in patients with premature ejaculation ( PE ) and to examine whether the premature ejaculation diagnostic tool ( PEDT ) can be used as a measure of treatment response in these patients .
METHODS	A total of 218 PE patients were randomized into control ( n = 61 ) and treatment ( n = 157 ) groups to receive mycelium of cordyceps sinensis C4 and sertraline 50mg daily for 8weeks , respectively .
METHODS	Following this blinded stage , sixty-three patients chose to take sertraline 100mg daily for an additional 4-week period , and 80 other patients continued treatment with sertraline 50mg .
METHODS	Main outcome measures include intravaginal ejaculatory latency time ( IELT ) , PEDT score and Clinical Global Impression of Change ( CGIC ) score .
RESULTS	At weeks 4 and 8 , mean IELT of patients who subsequently chose to take 100mg of sertraline was significantly lower than that of patients who continued taking 50mg of sertraline , although the IELT value was comparable between the two groups of patients at baseline .
RESULTS	However , with an additional 4-week treatment , the mean IELT increased significantly more in the 100-mg group than in the 50-mg continuation group .
RESULTS	Similar results were also obtained in the analyses of the PEDT and CGIC scores .
RESULTS	Both regimens were well tolerated , and relapse rate did not differ significantly between the two groups .
CONCLUSIONS	These findings suggest that PE patients not responding to an 8-week treatment with sertraline 50mg can benefit from an additional 4-week treatment with sertraline 100mg and that the PEDT may be a valid measure of treatment response in PE patients .

###25015176
BACKGROUND	The long-acting muscarinic antagonist ( LAMA ) umeclidinium ( UMEC ) and the combination of UMEC with the long-acting 2-agonist ( LABA ) vilanterol ( UMEC/VI ) are approved maintenance treatments for chronic obstructive pulmonary disease ( COPD ) in the US and EU .
BACKGROUND	They are not indicated for the treatment of asthma .
METHODS	In this 52-week , double-blind , placebo-controlled , parallel-group safety study ( GSK study DB2113359 ; NCT01316887 ) , patients were randomized 2:2:1 to UMEC/VI 125/25 mcg , UMEC 125 mcg , or placebo .
METHODS	Study endpoints included adverse events ( AEs ) , clinical chemistry and hematology parameters , vital signs , 12-lead , and 24-hour Holter electrocardiograms .
METHODS	COPD exacerbations and rescue medication use were assessed as safety parameters ; lung function was also evaluated .
RESULTS	The incidence of on-treatment AEs , serious AEs ( SAEs ) , and drug-related AEs was similar between treatment groups ( AEs : 52-58 % ; SAEs : 6-7 % ; drug-related AEs : 12-13 % ) .
RESULTS	Headache was the most common AE in each treatment group ( 8-11 % ) .
RESULTS	AEs associated with the LAMA and LABA pharmacologic classes occurred at a low incidence across treatment groups .
RESULTS	No clinically meaningful effects on vital signs or laboratory assessments were reported for active treatments versus placebo .
RESULTS	The incidences of atrial arrhythmias with UMEC/VI 125/25 mcg were similar to placebo ; for UMEC 125 mcg , the incidences of ectopic supraventricular beats , sustained supraventricular tachycardia , and ectopic supraventricular rhythm were 2 % greater than placebo .
RESULTS	With active treatments , COPD exacerbations were fewer ( 13-15 % of patients reporting 1 exacerbation ) and on average less rescue medication was required ( 1.6-2 .2 puffs/day ) versus placebo ( 24 % reporting 1 exacerbation , 2.6 puffs/day ) .
RESULTS	Both active treatments improved lung function versus placebo .
CONCLUSIONS	UMEC/VI 125/25 mcg and UMEC 125 mcg were well tolerated over 12months in patients with COPD .

###24761912
BACKGROUND	Retinoblastoma is a rare malignant intraocular neoplasm .
BACKGROUND	About 90 % of cases feature a germline mutation in the RB1 gene and these will develop retinoblastoma during their early childhood .
BACKGROUND	An association between mutations in germline cells and aging has been demonstrated .
BACKGROUND	This suggests a higher incidence of childhood cancer including retinoblastoma among children of older parents .
METHODS	In the present study we aimed to determine the association of paternal and maternal age with an increased risk of retinoblastoma in a case-control study in Iranian population .
METHODS	The study was carried out on 240 persons who were born during 1984-2012 in Mahak and Mofid hospitals in Tehran , Iran .
METHODS	The statistical analysis included studying the mean age of parents and in order to know whether parental age of patients is different from parental age of control group , ( t-test ) compare averages test is used perfectly .
METHODS	By binary logistic regression , odds ratios ( ORs ) and 95 % confidence intervals ( CIs ) were calculated .
RESULTS	The results of statistical analysis including the study of mean parental age by the use of ( t-test ) compare averages test showed a significant difference between parental ages of patients and controls .
RESULTS	Logistic regression showed that coefficients were significant for maternal but not paternal age .
CONCLUSIONS	Our findings indicate that advanced maternal age can increase the risk of retinoblastoma in offspring , but the paternal age has no significant effect .

###25845224
OBJECTIVE	To observe the curative effect of acupoint-injection and intramuscular-injection of Bacillus Calmette-Guerin ( BCG ) Polysaccharide Nucleic Acid for bronchial asthma .
METHODS	Sixty patients with bronchial asthma were equally randomized into acupoint-injection group and intramuscular-injection group .
METHODS	For patients of the acupoint-injection group , 2 mL of BCG was injected into bilateral Feishu ( BL 13 , 1 mL for one side ) once per day in the first 15 days , and once every other day in the rest 2.5 months except weekends .
METHODS	Intramuscular-injection was conducted at the lateral sites of the left or right buttock , 2 mL/time for each site , and the injection frequency was the same to that of the acupoint-injection .
METHODS	The therapeutic effect was assessed according to the standards of Guide Principles for Clinical Research of New Chinese Herbal Drugs ( 2002 ) and Asthma Group of Breathing Diseases of China Medical Association ( 2008 ) .
METHODS	Changes of FEV 1 ( forced expiratory volume in the first second ) / FVC ( forced vital capacity ) and PEF % ( peak expiratory flow ) were detected using a pulmonary function detector .
METHODS	Serum IgA , IgM , IgG and IgE contents were assayed by using an autonomic biochemical analyzer .
RESULTS	After 3 months ' treatment , the scores of patients ' symptoms and signs and serum IgE and IgG levels were significantly decreased in both muscular-injection and acupoint-injection groups ( P < 0.01 ) , while asthma controlled test ( ACT ) scores FEV 1/FVC % and PEF % values were considerably increased in both groups compared to pre-treatment in the same one group ( P < 0.01 ) .
RESULTS	The effects of acupoint-injection were markedly superior to those of the intramuscular-injection in reducing clinical symptom-sign score , and serum IgE content , and in up-regulating ACT score , FEV 1/FVC % and PEF % levels ( P < 0.05 , P < 0.01 ) .
RESULTS	There were no significant differences in serum IgG , IgA and IgM levels between the two groups 3 months following the treatment ( P > 0.05 ) .
CONCLUSIONS	Acupoint-injection of BCG polysaccharide nucleic acid can effectively improve bronchial asthma patients ' clinical symptoms and sings and pulmonary function , which may be closely associated with its function in down-regulating serum IgE and IgG levels .

###24707021
BACKGROUND	Omega-3 fatty acids supplements lower triglyceride ( TG ) levels in adults ; little pediatric information is available .
BACKGROUND	We evaluated their effect in hypertriglyceridemic adolescents .
METHODS	Twenty-five patients aged 10 to 19 years with TG levels 150 to 1000 mg/dL were randomized to 6 months double-blind trial of Lovaza ( ~ 3360 mg docosahexaenoic acid + eicosapentaenoic acid per day ) versus placebo .
RESULTS	Baseline mean TG levels were 227 mg/dL ( standard deviation = 49 ) .
RESULTS	TG levels declined at 3 months in the Lovaza group by 54 27 mg/dL ( mean standard error ; P = .02 ) and by 34 26 mg/dL ( P = .16 ) in the placebo group .
RESULTS	The difference in TG lowering between groups was not significant ( P = .52 ) .
RESULTS	There were no between-group differences in endothelial function , blood pressure , body mass index , C-reactive protein , or side effects .
CONCLUSIONS	High-dose omega-3 fatty acid supplements are well tolerated in adolescents .
CONCLUSIONS	However , declines in TG levels did not differ significantly from Placebo in this small study .

###24962230
OBJECTIVE	The objective of this study was to ascertain whether clinicians can reliably distinguish between spasmodic dysphonia ( SD ) / vocal tremor and other voice disorders by telephone , despite this modality 's limited frequency response .
METHODS	Randomized , single-blinded , and prospective study .
METHODS	Voice-disordered patients with ( n = 22 ) and without ( n = 17 ) SD and/or vocal tremor recorded standardized utterances via landline telephone .
METHODS	A laryngologist and two speech-language pathologists blinded to the diagnoses rated each recording as `` yes '' or `` no '' to `` SD or tremor present ?
METHODS	, '' and if `` yes '' categorized into adductor , abductor , tremor only , or adductor with tremor subtypes .
METHODS	Twenty-one recordings were presented twice at random so intrarater reliability could be assessed .
METHODS	All ratings were compared with gold standard diagnosis by a second laryngologist who performed a full examination , including videostroboscopy , on each patient .
RESULTS	For the comparison `` SD or tremor '' yes versus no , sensitivity , specificity , positive predictive value , and negative predictive value are 90 % , 95 % , 96 % , and 89 % , respectively .
RESULTS	Interrater reliability ( Cohen kappa ) compared with the gold standard ranged from 0.70 to 0.93 ( substantial to almost perfect agreement ) .
RESULTS	Cronbach alpha among three raters was 0.90 for this comparison .
RESULTS	Intrarater reliability ( number matched/number inspected ) was very high , ranging from0 .97 to 1.0 .
RESULTS	Comparing gold standard and telephone rating of SD/tremor subtypes , kappa ranged from 0.48 to 0.60 ( moderate agreement ) .
RESULTS	Cronbach alpha among three raters was 0.88 for this comparison .
RESULTS	Intrarater reliability ranged from 0.84 to 0.97 .
CONCLUSIONS	SD and tremor can be reliably distinguished from other voice disorders over the telephone .

###24292557
BACKGROUND	Contrast-induced nephropathy ( CIN ) , an acute kidney injury resulting from the administration of intravascular iodinated contrast media , is an important cause of morbidity/mortality following coronary angiographic procedures in high-risk patients .
BACKGROUND	Despite preventative measures intended to mitigate the risk of CIN , there remains a need for an effective intervention .
BACKGROUND	Remote ischaemic conditioning ( RIC ) , where non-injurious ischaemia is applied to an arm prior to the administration of contrast , has shown promise in attenuating CIN but its effectiveness in preserving long-term renal function is unknown , which will be studied as part of the effect of remote ischaemic conditioning against contrast-induced nephropathy ( ERICCIN ) trial .
BACKGROUND	( http://Controlled-trials.com Identifier : ISRCTN49645414 . )
METHODS	The ERICCIN trial is a single-centre , randomised double-blinded placebo-controlled trial which plans to recruit 362 patients who are at risk of CIN , defined by pre-existent renal impairment ( estimated glomerular filtration rate < 60 ml/min/1 .73 m2 ) , over a period of 2 years .
METHODS	Patients will be randomised to either control or RIC consisting of 4 , 5 min 200 mmHg balloon-cuff inflation/deflations , to the upper arm .
METHODS	The primary endpoint will be the development of CIN ( > 25 % of eGFR , or rise of creatinine of > 44 mol/l ) at 48 h.
METHODS	A key secondary endpoint will be whether RIC impacts upon persistent renal impairment over the 3-month follow-up period .
METHODS	Additional secondary endpoints include the measurement of serum neutrophil gelatinase-associated lipocalin and urinary albumin at 6 , 48 h and 3 months following administration of contrast .
CONCLUSIONS	Findings from ERICCIN trial will potentially demonstrate that RIC attenuates contrast-induced acute and chronic kidney injury and influence future clinical practice guidelines in at-risk patients undergoing coronary angiographic procedures .

###25059982
OBJECTIVE	To investigate the effects of sitagliptin therapy on the kinetics of triglyceride-rich lipoprotein ( TRL ) apolipoprotein ( apo ) B-48 , VLDL apoB-100 , apoE and apoC-III in patients with type 2 diabetes .
METHODS	Twenty-two subjects with type 2 diabetes were recruited in this double-blind crossover study , during which the subjects received sitagliptin ( 100 mg/day ) or placebo for a 6-week period each .
METHODS	At the end of each phase of treatment , the in vivo kinetics of the different apolipoproteins were assessed using a primed-constant infusion of l - [ 5,5,5-D3 ] leucine for 12 h , with the participants in a constantly fed state .
RESULTS	Sitagliptin therapy significantly reduced fasting plasma triglyceride ( -15.4 % , p = 0.03 ) , apoB-48 ( -16.3 % , p = 0.03 ) and free fatty acid concentrations ( -9.5 % , p = 0.04 ) , as well as plasma HbA1c ( placebo : 7.0 % 0.8 vs. sitagliptin : 6.6 % 0.7 , p < 0.0001 ) and plasma glucose levels ( -13.5 % , p = 0.001 ) , without any significant effect on insulin levels .
RESULTS	Kinetic results showed that treatment with sitagliptin significantly reduced the pool size of TRL apoB-48 by -20.8 % ( p = 0.03 ) , paralleled by a reduction in the production rate of these particles ( -16.0 % , p = 0.03 ) .
RESULTS	The VLDL apoB-100 pool size was also significantly decreased by sitagliptin therapy ( -9.3 % , p = 0.03 ) , mainly because of a reduction in the hepatic secretion of these lipoproteins , although this difference did not reach statistical significance ( -9.2 % , p = 0.06 ) .
CONCLUSIONS	Treatment with sitagliptin for 6 weeks reduced triglyceride-rich apoB-containing lipoprotein levels by reducing the synthesis of these particles .

###25146067
BACKGROUND	It has previously been reported that increased level of serum heat shock proteins ( Hsps ) antibody in patients with metabolic syndrome .
BACKGROUND	It is possible that the expression of Hsp and inflammatory markers can be affected by cupping and traditional Chinese medicine .
BACKGROUND	There is a little data investigating the effects of cupping on markers of inflammation and Hsp proteins , hence , the objective of this study was evaluation of the effects of wet cupping on serum high-sensitivity C-reactive protein ( hs-CRP ) and Hsp27 antibody titers in patients with metabolic syndrome .
METHODS	Serum Hs-CRP and Hsp27 antibody titers were assessed in samples from 126 patients with metabolic syndrome ( 18-65 years of age ) at baseline , and after 6 and 12 weeks after treatment .
METHODS	One hundred and twenty-six patients were randomly divided into the experimental group treated with wet cupping combined with dietary advice , and the control group treated with dietary advice alone using a random number table .
METHODS	Eight patients in case group and five subjects in control groups were excluded from the study .
METHODS	Data were analyzed using SPSS 15.0 software and a repeated measure ANCOVA .
RESULTS	Serum hs-CRP titers did not change significantly between groups ( p > 0.05 ) and times ( p = 0.27 ) .
RESULTS	The same result was found for Hsp27 titers ( p > 0.05 ) .
CONCLUSIONS	Wet-cupping on the interscapular region has no effect on serum hs-CRP and Hsp27 patients with metabolic syndrome .

###25957143
BACKGROUND	The aim of this study was to ascertain if a modified carotid sinus massage ( CSM ) using ultrasonography is superior to the conventional CSM for vagal tone generation .
METHODS	This was a prospective , crossover , clinical trial including 30 subjects with sinus rhythm .
METHODS	Participants were paired , and they performed 2 types of CSM to each other .
METHODS	To perform the conventional technique , pressure was exerted at the point where the maximal impulse of the carotid pulse was palpated .
METHODS	In the modified technique , participants localized the point of maximal diameter just above the bifurcation of the common carotid artery using ultrasonography and applied pressure to that point .
METHODS	Mean differences between premaneuver and postmaneuver R-R intervals and heart rates were compared .
METHODS	The distance from the midline of the neck ( x distance ) to the angle of the mandible ( y distance ) was measured , and the mean distance between the 2 techniques was compared .
RESULTS	The baseline mean premaneuver R-R interval and heart rate did not differ significantly between the 2 techniques .
RESULTS	The postmaneuver R-R interval and heart rate as well as the mean R-R interval and heart rate differences were significantly greater in the modified CSM .
RESULTS	The mean location determined using the modified CSM was located 0.8 cm lateral and 0.8 cm superior to the mean location of the conventional CSM .
CONCLUSIONS	The modified CSM using ultrasonography might be more useful than the conventional CSM in reverting episodes of paroxysmal supraventricular tachycardia and may be a suitable alternative for treating the same in the emergency department .

###24516695
OBJECTIVE	Flumazenil was administered after the completion of endoscopy under sedation to reduce recovery time and increase patient safety .
OBJECTIVE	We evaluated patient satisfaction after endoscopy under sedation according to the timing of a postprocedural flumazenil injection .
METHODS	In total , 200 subjects undergoing concurrent colonoscopy and upper endoscopy while sedated with midazolam and meperidine were enrolled in our investigation .
METHODS	We randomly administered 0.3 mg of flumazenil either immediately or 15 minutes after the endoscopic procedure .
METHODS	A postprocedural questionnaire and next day telephone interview were conducted to assess patient satisfaction .
RESULTS	Flumazenil injection timing did not affect the time spent in the recovery room when comparing the two groups of patients .
RESULTS	However , the subjects in the 15 minutes injection group were more satisfied with undergoing endoscopy under sedation than the patients in the immediate injection group according to the postprocedural survey ( p = 0.019 ) .
RESULTS	However , no difference in overall satisfaction , memory , or willingness to undergo a future endoscopy was observed between the two groups when the telephone survey was conducted on the following day .
CONCLUSIONS	This study demonstrated that a delayed flumazenil injection after endoscopic sedation increased patient satisfaction without prolonging recovery time , even though the benefit of the delayed flumazenil injection did not persist into the following day .

###25750540
BACKGROUND	The degree of glycemic control in patients with type 2 diabetes mellitus ( T2DM ) may alter lipid levels and may alter the efficacy of lipid-modifying agents .
OBJECTIVE	Evaluate the lipid-modifying efficacy of extended-release niacin/laropiprant ( ERN/LRPT ) in subgroups of patients with T2DM with better or poorer glycemic control .
METHODS	Post hoc analysis of clinical trial data from patients with T2DM who were randomized 4:3 to double-blind ERN/LRPT or placebo ( n = 796 ) , examining the lipid-modifying effects of ERN/LRPT in patients with glycosylated hemoglobin or fasting plasma glucose levels above and below median baseline levels .
RESULTS	At Week 12 of treatment , ERN/LRPT significantly improved low-density lipoprotein cholesterol , high-density lipoprotein cholesterol ( HDL-C ) , non-high-density lipoprotein cholesterol , triglycerides , and lipoprotein ( a ) , compared with placebo , with equal efficacy in patients above or below median baseline glycemic control .
RESULTS	Compared with placebo , over 36 weeks of treatment more patients treated with ERN/LRPT had worsening of their diabetes and required intensification of antihyperglycemic medication , irrespective of baseline glycemic control .
RESULTS	Incidences of other adverse experiences were generally low in all treatment groups .
CONCLUSIONS	The lipid-modifying effects of ERN/LRPT are independent of the degree of baseline glycemic control in patients with T2DM ( NCT00485758 ) .

###25626066
BACKGROUND	A combination of scintigraphy and a lymphotropic dye ( patent blue dye ( BD ) ) is the recommended technique to detect the sentinel lymph node ( SLN ) in early breast cancer .
BACKGROUND	This study determined the effect of clinical factors on SLN identification in the sentinel node biopsy versus axillary clearance ( SNAC ) trial .
METHODS	A total of 1088 women were registered .
METHODS	Lymphatic mapping was performed using preoperative lymphoscintigraphy ( LSG ) and gamma probe ( GP ) combined with peritumoural injection of patent BD ( 971 patients ) or BD alone ( 106 patients ) .
RESULTS	SLNs were identified in 1024 women ( 94 % ) , localized with LSG in 779 ( 81.4 % ) , and were identified by GP in 879 ( 91.8 % ) .
RESULTS	The BD identified SLNs in 890 of 1073 ( 82 % ) women .
RESULTS	Three patients had allergic reactions .
RESULTS	BD detected the SLNs in 141 of 178 women with negative LSG mapping and in 44 of 79 women with no hot SLNs detected intraoperatively .
RESULTS	Age , body mass index ( BMI ) and tumour presentation ( screen detected versus symptomatic ) were significantly related to the identification of the SLN .
RESULTS	For BD , the primary tumour location was significantly related to identification rate .
RESULTS	The detection of blue SLN was significantly lower in women with inner quadrant tumours .
CONCLUSIONS	The combined technique resulted in a high identification rate .
CONCLUSIONS	BD contributed to the identification of the SLNs in patients where LSG and GP failed to identify the sentinel node .
CONCLUSIONS	Special attention to these techniques is needed in particular groups of patients such as those with high BMI , screen-detected primary tumours and tumour located in the inner quadrants .

###25384473
BACKGROUND	To compare the clinical , analytical and graft maturation effects of two different platelet-rich plasma ( PRP ) preparations applied during anterior cruciate ligament ( ACL ) reconstruction .
METHODS	A total of 150 patients with ACL disruption were included in the study .
METHODS	Arthroscopic ACL reconstruction with patellar tendon allograft was conducted on all knees using the same protocol .
METHODS	One hundred patients were prospectively randomised to either a group to receive double-spinning platelet-enriched gel ( PRP ) with leukocytes ( n = 50 ) or to a non-gel group ( n = 50 ) .
METHODS	Finally , we included 50 patients treated with a platelet-rich preparation from a single-spinning procedure ( PRGF Endoret ( ) Technology ) without leukocytes .
METHODS	Inflammatory parameters , including C-reactive protein ( CRP ) and knee perimeters ( PER ) , were measured 24 hours and 10 days after surgery .
METHODS	Postoperative pain score ( visual analogue score [ VAS ] ) was recorded the day after surgery .
METHODS	Follow-up visits occurred postoperatively at 3 , 6 , and 12 months .
METHODS	The International Knee Documentation Committee scale ( IKDC ) was included to compare functional state , and MRI was conducted 6 months after surgery .
RESULTS	The PRGF group showed a statistically significant improvement in swelling and inflammatory parameters compared with the other two groups at 24 hours after surgery ( p < 0.05 ) .
RESULTS	The results did not show any significant differences between groups for MRI and clinical scores .
CONCLUSIONS	PRGF used in ACL allograft reconstruction was associated with reduced swelling ; however , the intensity and uniformity of the graft on MRI were similar in the three groups , and there was no clinical or pain improvement compared with the control group .
METHODS	II .

###25387783
BACKGROUND	Despite calls to expand measurement of acute myocardial infarction ( AMI ) outcomes to include symptom burden , little has been done to describe hospital-level variation in this patient-centered outcome , or its association with mortality .
BACKGROUND	Understanding the relationship between symptoms and longer-term mortality could inform the importance of these outcomes for monitoring quality of care .
RESULTS	Among 4316 patients with AMI treated at 24 hospitals participating in the Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction Patients ' Health Status ( TRIUMPH ) study , we assessed risk-standardized 1-year symptom burden as measured by the Seattle Angina Questionnaire Angina Frequency Score and mortality attributed to the hospital that provided AMI care .
RESULTS	Median odds ratios were used to assess outcome variation and reflect the relative odds of an outcome for 2 patients with identical covariates at different , randomly selected , hospitals .
RESULTS	We then evaluated the correlation between hospital-level mortality and angina .
RESULTS	Finally , we determined the extent to which variation in mortality and angina was explained by achievement of AMI performance measures .
RESULTS	We observed hospital variation in risk-adjusted 1-year mortality ( range , 4.9 % -8.6 % ; median odds ratio , 1.30 ; P = 0.01 ) and angina ( range , 17.7 % -29.4 % ; median odds ratio , 1.34 ; P < 0.001 ) .
RESULTS	At the hospital level , mortality and angina at 1 year were weakly correlated ( r = 0.40 ; 95 % confidence interval , 0.00-0 .68 ; P = 0.05 ) .
RESULTS	Accounting for the quality of AMI care did not attenuate variation in risk-adjusted 1-year mortality or angina .
CONCLUSIONS	Symptom burden and mortality vary at the hospital level after AMI and are only weakly correlated .
CONCLUSIONS	These findings suggest that symptom burden should be considered a separate quality domain that is not well captured by current quality metrics .

###25238860
BACKGROUND	Forty to sixty percent of MS patients suffer from cognitive impairments .
BACKGROUND	Cognitive deficits are a great burden for patients affected .
BACKGROUND	In particular they may lead to a reduced quality of life , loss of work and problems with the social environment .
OBJECTIVE	The aim of this study was to evaluate a specific neuropsychological rehabilitation program for MS patients according to the ICF to be able to meet more properly individual requirements on the therapy level of function as well as of activities and participation .
METHODS	Forty patients with MS were randomised in an intervention ( IG ) - and a control group ( CG ) .
METHODS	The outcome measure of the IG , who started an intensive computer based home training of attention and attended psychological counselling was compared to the untrained CG .
RESULTS	In specific domains of attention ( simple and cued alertness and divided attention ) significant group differences between CG and IG could be found .
RESULTS	The IG reported an improvement of mental fatigue and retardation .
CONCLUSIONS	These findings support the idea that a neuropsychological rehabilitation program , which based on the model of ICF , could improve cognitive impairment and could also have a positive influence of activities and participation .

###24236573
BACKGROUND	The results of weight maintenance after initial weight loss are reported infrequently , although , when they have been reported , the outcomes are generally poor and weight regain is common .
METHODS	After an initial 12-week randomised intervention comparing all meal provision against a self-directed energy restriction , participants re-consented to participate in a follow-on study .
METHODS	Participants were given the option to choose to continue with the same dietary intervention ( either all meal provision ( provided free of charge ) or self-directed diet ) or change to the other diet for a further 12 weeks .
METHODS	Participants were followed up at 4-weekly intervals during both intervention periods ( a total of 24 weeks ) , with a final follow up at 12 months .
RESULTS	Eighty-five out of 86 individuals who completed the original 12-week randomised phase chose to continue on to the follow-up study .
RESULTS	No significant differences in further weight loss between groups ( P = 0.138 ) [ mean ( SEM ) : -3.4 % ( 1.1 % ) for all meal provision only ; -3.4 % ( 0.6 % ) self-directed then all meal provision ; -1.1 % ( 1.2 % ) all meal provision then self-directed ] were seen after a further 12 weeks .
RESULTS	Meal provision for a total of 24 weeks resulted in 67 % of individuals losing at least 10 % body weight .
RESULTS	The groups switching from self-directed dieting to meal provision ( or vice versa ) were the only groups to have a lower mean weight at 12 months than at the start of the follow-on study .
CONCLUSIONS	Structured support for 24 weeks followed by 28 weeks of self-care can result in weight maintenance , with initial weight loss maintained at 12 months from enrolling on a 12-week weight loss intervention , with a 12-week follow-on period .

###24238346
BACKGROUND	A diagnosis of diabetes mellitus types 1 or 2 doubles the odds of a comorbid depressive disorder .
BACKGROUND	The combined diseases have a wide range of adverse outcomes , such as a lower quality of life , poorer diabetes outcomes and increased healthcare utilisation .
BACKGROUND	Diabetes patients with depression can be treated effectively with psychotherapy , but access to psychological care is limited .
BACKGROUND	In this study we will examine the efficacy and cost-effectiveness of a newly developed web-based intervention ( GET.ON Mood Enhancer Diabetes ) for people with diabetes and comorbid depressive symptoms .
METHODS	A two-arm randomised controlled trial will be conducted .
METHODS	Adults with diabetes ( type 1 or type 2 ) with increased depression scores ( > 22 on the German version of the Center for Epidemiological Studies Depression Scale ( CES-D ) ) will be included .
METHODS	Eligible participants will be recruited through advertisement in diabetes patient journals and via a large-scale German health insurance company .
METHODS	The participants will be randomly assigned to either a 6-week minimally guided web-based self-help program or an online psychoeducation program on depression .
METHODS	The study will include 260 participants , which will enable us to detect a statistically significant difference with a group effect size of d = 0.35 at a power of 80 % and a significance level of p = 0.05 .
METHODS	The primary outcome measure will be the level of depression as assessed by the CES-D .
METHODS	The secondary outcome measures will be : diabetes-specific emotional distress , glycaemic control , self-management behaviour and the participants ' satisfaction with the intervention .
METHODS	Online self-assessments will be collected at baseline and after a 2 months period , with additional follow-up measurements 6 and 12 months after randomisation .
METHODS	The data will be analysed on an intention-to-treat basis and per protocol .
METHODS	In addition , we will conduct an economic evaluation from a societal perspective .
CONCLUSIONS	If this intervention is shown to be cost-effective , it has considerable potential for implementing psychological care for large numbers of people with diabetes and comorbid depression in routine practice and improve health outcomes .
BACKGROUND	German Clinical Trial Register ( DRKS ) : DRKS00004748 .

###25121804
OBJECTIVE	Determine efficacy and safety of acetaminophen extended release ( ER ) 1300mg given three times daily compared to placebo for relieving signs and symptoms of hip or knee osteoarthritis .
METHODS	Sixty investigators at 58 private , ambulatory , primary care sites in the US enrolled 542 outpatient adults 40 years old with moderate to severe idiopathic osteoarthritis pain into a randomized , placebo-controlled , double-blind 12 week clinical trial .
METHODS	Patients were randomly assigned to treatment given three times daily of acetaminophen 1300mg ( n = 267 ) or placebo ( n = 275 ) .
RESULTS	The three primary endpoints measured through week 12 favored acetaminophen ER as follows : least squares ( LS ) mean change from baseline for WOMAC physical function subscale score was significantly greater for acetaminophen ER than for placebo ( P = 0.011 ) ; LS mean patient 's global assessment of response to therapy was significantly greater for acetaminophen ER than for placebo ( P = 0.010 ) ; and LS mean change from baseline for WOMAC pain subscale score was marginally greater for acetaminophen ER than for placebo ( P = 0.054 ) .
RESULTS	LS mean change from baseline for secondary endpoints through week 12 also favored acetaminophen ER compared with placebo : significantly for WOMAC stiffness subscale score ( P = 0.004 ) , significantly for WOMAC total index score ( P = 0.013 ) , and marginally for Nottingham Health Profile energy subscale score ( P = 0.057 ) .
RESULTS	The percentage of patients with any adverse event was similar for both treatment groups .
RESULTS	Hepatic transaminases exceeded 3ULN in seven acetaminophen ER patients and one placebo patient .
RESULTS	Elevations were attributed to health conditions in three of seven acetaminophen ER patients ; elevations in the remaining four patients returned to or toward normal .
CONCLUSIONS	Acetaminophen ER 1300mg , a nonprescription drug , given three times daily , can provide effective relief of signs and symptoms of osteoarthritis of the hip or knee and was well tolerated .
CONCLUSIONS	ClinicalTrials.gov registration number : NCT00240799 .

###25741842
BACKGROUND	Hypotension is a common complication following spinal anesthesia for cesarean delivery .
BACKGROUND	Techniques to prevent hypotension include preloading intravenous fluid .
OBJECTIVE	To compare the effect of two preloading regimens : 6 % hydroxyethyl starch ( HES ) and 9 saline solution , to prevent hypotension after spinal anesthesia in cesarean delivery .
METHODS	105 patients undergoing intrathecal anesthesia for elective cesarean delivery were randomized and allocated to receive a preload of 500 ml HES 130/0 .4 ( HES Group ) or a preload of 1500 ml 9 saline solution ( CR group ) .
METHODS	Blood pressure and heart rate were recorded at baseline and after spinal anesthesia ( every minute for the first 10 min , every 3 min for the next 10 min , and then every 5 min for the last 20 min ) .
METHODS	The primary outcome was to compare the incidence of hypotension ( defined as a 20 % reduction in systolic arterial pressure from baseline ) between the two preloading regimens .
METHODS	Vasopressor requirements ( i.v. bolus of 6 mg ephedrine ) were also compared .
RESULTS	The incidence of hypotension was 87 % in the CR group and 69 % in the HES group ( p = 0.028 ) .
RESULTS	Ephedrine requirement , incidence of nausea , and/or vomiting and neonatal outcome did not significantly differ between the two groups .
CONCLUSIONS	The incidence of hypotension was lower after preloading of 500 mL of HES 130/0 .4 than preloading with 1500 mL of 9 saline solution .

###24389416
OBJECTIVE	Osteoporosis and atherosclerosis are interconnected entities and share also some pathophysiological mechanisms .
OBJECTIVE	Moreover , recent literature data have supported the hypothesis that bisphosphonates ( BPs ) may have some antiatherogenic actions .
OBJECTIVE	This study aimed to evaluate the effects of one year with zoledronate or ibandronate given intravenously on lipid profile and on carotid artery intima-media thickness ( CA-IMT ) .
METHODS	Sixty postmenopausal osteoporotic women ( mean age : 66.67.8 years ) were randomly assigned to 1-year treatment with zoledronate 5mg i.v. annually or ibandronate 3mg i.v. every 3 months .
METHODS	In all patients at baseline and after 12months we measured CA-IMT , total cholesterol ( TC ) , high-density lipoprotein cholesterol ( HDL-C ) , low-density lipoprotein cholesterol ( LDL-C ) , 25-hydroxyvitamin D ( 25OHD ) , bone alkaline phosphatase ( B-ALP ) , type I collagen carboxy telopeptide ( CTX ) , osteocalcin ( OC ) , fibroblast growth factor 23 ( FGF-23 ) and sclerostin .
RESULTS	The osteoporotic women treated with zoledronate showed a greater reduction in CA-IMT than those treated with ibandronate .
RESULTS	HDL-C and HDL-C/LDL-C ratio showed a significant ( p < 0.01 ) increase in the 2 groups , whereas , LDL-C showed a reduction in the two groups which , however , reached statistical significance ( p < 0.05 ) only in the zoledronate group .
RESULTS	FGF-23 serum levels showed a similar and significant decrease in both the women treated with zoledronate and in those treated with ibandronate .
RESULTS	At the end of the study period sclerostin serum levels showed a higher increase in the patients treated with zoledronate than in those treated with ibandronate .
CONCLUSIONS	In osteoporotic women both zoledronate and ibandronate given intravenously resulted in an increase in HDL-C/LDL-C ratio and a reduction of CA-IMT which was significant only for zoledronate .
CONCLUSIONS	Further prospective studies are needed to clarify whether the change in FGF-23 and sclerostin levels is a marker or a potential mechanism of the action of BPs at a vascular level .

###25639864
BACKGROUND	The current study was performed to report the long-term results of a trial comparing concurrent chemotherapy and radiotherapy ( CCRT ) with surgery and adjuvant radiotherapy ( RT ) in patients with stage III/IV nonmetastatic head and neck squamous cell carcinoma .
METHODS	Patients with stage III/IV resectable head and neck squamous cell carcinoma were randomized to surgery followed by RT or CCRT .
METHODS	The trial was halted prematurely due to poor accrual .
METHODS	Human papillomavirus status was tested on archival material using polymerase chain reaction sequencing .
RESULTS	Of the total of 119 patients , 60 patients were randomized to primary surgery ( S arm ) and 59 patients were randomized to CCRT ( C arm ) .
RESULTS	Human papillomavirus status was tested in 75 patients , and only 3 were found to be positive .
RESULTS	The median follow-up for surviving patients was 13 years .
RESULTS	Analysis of the entire cohort demonstrated no statistically significant difference in overall survival and disease-specific survival ( DSS ) : 5-year rates were 45 % versus 35 % for overall survival ( P = .262 ) and 56 % versus 46 % for DSS ( P = .637 ) for the S arm and C arm , respectively .
RESULTS	Analysis by subsites indicated that this difference favoring the S arm was mainly driven by survival data among patients with cancers of the oral cavity and maxillary sinus .
RESULTS	For patients with oral cavity cancer , survival was significantly better in those who underwent primary surgery compared with CCRT ; the 5-year DSS rate was 68 % versus 12 % for the S arm and C arm , respectively ( P = .038 ) .
RESULTS	For patients with cancers of the maxillary sinus , the 5-year DSS rate was 71 % for patients on the S arm and 0 % for patients on the C arm ( P = .05 ) .
CONCLUSIONS	These long-term results demonstrate a significant advantage for primary surgery in patients with cancers of the oral cavity or maxillary sinus , providing strong support for primary surgery as the main modality of treatment for these subsites .
CONCLUSIONS	In other subsites , CCRT and surgery with adjuvant RT were found to demonstrate similar efficacy for survival in patients with advanced resectable tumors .

###25711331
OBJECTIVE	Liver disease is increasingly recognized in HIV-positive individuals , even among those without viral hepatitis , partly as a result of the recent availability of noninvasive methods of liver fibrosis assessment .
OBJECTIVE	The objective of this substudy is to compare the effects of early versus deferred antiretroviral therapy ( ART ) on liver fibrosis progression .
METHODS	Sites in the Strategic Timing of AntiRetroviral Treatment ( START ) study with access to FibroScan were invited to participate in the Liver Fibrosis Progression Substudy .
METHODS	All substudy participants underwent FibroScan at baseline , and two noninvasive serum algorithms , APRI and FIB-4 , were calculated .
METHODS	Demographic and liver-related information was collected for all START participants at baseline .
RESULTS	A total of 230 participants were enrolled in the substudy ( 11.5 % with hepatitis B or C virus coinfection ) , of whom 221 had a valid transient elastography ( TE ) result .
RESULTS	The median TE score was 4.9 kPa [ interquartile range ( IQR ) 4.3-6 .0 kPa ] .
RESULTS	Seventeen patients ( 7.8 % ) [ 95 % confidence interval ( CI ) 5.1-12 .1 % ] had a TE score of > 7.2 kPa , indicating significant liver fibrosis .
RESULTS	Baseline factors associated with higher TE scores in multivariate analysis were higher alanine aminotransferase ( ALT ) per 10 U/L ( P = 0.045 ) , higher log10 HIV RNA ( P < 0.001 ) and Hispanic/Latino ethnicity ( P = 0.01 ) .
RESULTS	TE correlated weakly with noninvasive markers .
CONCLUSIONS	At baseline , significant liver fibrosis was observed in approximately 8 % of participants , with higher ALT and HIV RNA the only clinical factors associated with increasing TE score .
CONCLUSIONS	TE will be used annually to monitor fibrosis and evaluate the role of ART in further fibrosis progression .

###24518280
BACKGROUND	The study aim was to determine the effect of a dietary intervention on growth , body composition and resting energy expenditure ( REE ) in children with cystic fibrosis ( CF ) and pancreatic insufficiency ( PI ) in a randomized , double blind , placebo-controlled trial .
METHODS	Subjects ( 5 to 17 yrs ) participated in a 12-month trial of the organized lipid matrix LYM-X-SORB ( LXS ) vs. placebo dietary supplements with similar calories , total fat and fatty acids .
METHODS	Dietary intake was assessed using 3-day weighed food records .
METHODS	Height ( HAZ ) , weight ( WAZ ) , BMI ( BMIZ ) , mid-upper arm muscle ( UAMAZ ) and fat area ( UAFAZ ) Z-scores were calculated .
METHODS	Fat mass ( FM ) and fat-free mass ( FFM ) were obtained by whole body DXA .
METHODS	REE ( kcal/d ) was evaluated by indirect calorimetry at baseline , 3 and 12 months and % REE calculated using Schofield equations .
METHODS	No growth or REE differences were observed between LXS and placebo groups so data were pooled for analysis .
RESULTS	63 children ( 57 % males , age 10.6 2.9 yr , 43 % receiving LXS ) completed REE measurements .
RESULTS	Caloric intake increased from a median of 2502 [ 1478 , 4909 ] to 2616 [ 1660 , 4125 ] kcal/d at 12 months .
RESULTS	HAZ , WAZ and UAMAZ increased ( p < 0.05 ) over 12 months .
RESULTS	Mean REE was 109 8 % predicted at baseline and 107 9 % at 12 months ( p < 0.05 ) .
RESULTS	REE ( kcal/d ) adjusted for FFM and FM decreased over 12 months ( [ mean SE ] -31 12 kcals , p < 0.01 ) , significant only in males ( -49 16 kcals , p < 0.01 ) .
CONCLUSIONS	Over a 12 month nutrition intervention with either LXS or placebo , the growth status , muscle stores and REE improved .
CONCLUSIONS	Sustained increased energy intake improved energy metabolism , growth and nutritional status in school age children with CF , PI and mild lung disease .

###25178520
OBJECTIVE	In a randomized clinical trial , short - and long-term psychodynamic group psychotherapy ( STG and LTG , respectively ) schedules were equally effective for the ` typical ' patient during a 3-year study period .
OBJECTIVE	Although several studies have reported good effects for patients with personality disorders ( PD ) in diverse forms of psychotherapy , the significance of treatment duration is unclear .
OBJECTIVE	Therefore , we tested the hypothesis that PD patients would improve more during and after LTG than STG .
METHODS	A randomized , longitudinal , prospective study contrasting the outcomes during and after short - and long-term dynamic group psychotherapies .
METHODS	One hundred and sixty-seven outpatients with mood disorders , anxiety disorders , or PD were randomized to STG or LTG ( respectively , 20 or 80 weekly sessions of 90 min each ) .
METHODS	Outcome measures are as follows : symptoms ( SCL-90-R ) , interpersonal problems ( IIP-C ) , and psychosocial functioning ( GAF split version : GAF-Symptom and GAF-Function ) .
METHODS	PD pathology ( number of PD criteria items ) was selected a priori as a putative moderator of treatment effects .
METHODS	Change during the 3-year study period was assessed using linear mixed models .
METHODS	The study was registered at ClinicalTrials.gov as NCT 00021417 .
RESULTS	Our hypothesis was supported , as patients with PD improved significantly more regarding all outcome variables in LTG than STG .
RESULTS	For patients without PD , the rate of change was similar across 3 years ; however , the rate of change in symptoms and interpersonal problems was higher in STG during the first 6 months .
CONCLUSIONS	The effectiveness of LTG is higher for patients with co-morbid PD .
CONCLUSIONS	Patients without PD do not appear to experience additional gain from LTG .
CONCLUSIONS	Clinical implications : LTG demonstrates better effectiveness than STG for patients with personality disorder co-morbidity ( PD ) .
CONCLUSIONS	Patients without PD do not appear to experience additional gain from attending LTG .
CONCLUSIONS	Correct initial allocation to treatment duration may prevent disruptive breaks in relationships and lead to both human and economic cost savings .
CONCLUSIONS	Limitations : Trials on mixed diagnostic samples may limit the ability to fully assess change for specific diagnostic groups .
CONCLUSIONS	Therapists were unable to select patients and compose their own groups .
CONCLUSIONS	Although this condition might increase the generalizability of the results , it may also have restricted the therapists and the clinical situation inadvertently .

###24626998
BACKGROUND	Because data on contrast-induced acute kidney injury ( CI-AKI ) in patients undergoing cardiac resynchronization therapy ( CRT-D ) are scarce , we aimed to assess the incidence , natural course and prognostic importance of this syndrome in CRT recipients .
METHODS	Study population consisted of 100 consecutive patients enrolled into the Triple Site Versus Standard Cardiac Resynchronization ( TRUST CRT ) trial , who were treated with CRT-D .
METHODS	Two patients were excluded up to 3 months after randomization and not analysed further .
METHODS	CI-AKI was defined as a rise in serum creatinine of at least 26.5 mol/L ( 0.3 mg/dL ) within 48 h after contrast exposure , or at least 50 % increase from the baseline value during index hospital stay with CRT-D implantation according to KDIGO Clinical Practice Guideline for Acute Kidney Injury .
RESULTS	Among 98 subjects of TRUST CRT trial , 10 patients ( 10.2 % ) developed CI-AKI after CRT-D implantation .
RESULTS	In patients with glomerular filtration rate ( GFR ) < 60 mL/min/1 .73 m ( 2 ) on admission , the incidence of CI-AKI was almost twofold ( 15.4 % ) higher than in subjects with GFR 60 ( 8.3 % ) .
RESULTS	CRT-D recipients with CI-AKI had significantly higher mortality rate ( 50.0 % ) compared to those without CI-AKI ( 17.0 % ) during 30 months of follow-up ( logrank p = 0.012 ) .
RESULTS	Multivariate Cox regression analysis showed CI-AKI as significant and independent risk factor for death in CRT-D recipients ( hazard ratio 5.71 ; 95 % CI 5.16-6 .26 ; p = 0.001 ) .
CONCLUSIONS	Contrast-induced acute kidney injury is a serious and frequent procedural complication of CRT-D implantation with a significant negative influence on long-term survival .
CONCLUSIONS	The results suggest that clinical evaluation regarding renal function should be considered in CRT-D recipients , both before and after device implantation .

###24611925
OBJECTIVE	Previous analyses showed that a telephone-based intervention to increase physical activity in individuals with multiple sclerosis ( MS ) and depression resulted in significantly improved depressive symptoms compared to a wait-list control group .
OBJECTIVE	The aim of this study was to test positive affect and negative affect as mediators of the effect of the physical activity counseling on depressive symptoms .
METHODS	Ninety-two adults with MS , who met diagnostic criteria for either major depression or dysthymia and who reported low levels of physical activity , were randomized 1:1 to a 12-week telephone-based motivational interviewing ( MI ) intervention to improve physical activity ( n = 44 ) or to a 12-week wait-list control group ( n = 48 ) .
METHODS	Self-reported positive and negative affect , physical activity , and depressive symptoms were gathered at baseline and postintervention .
METHODS	Path-analysis was used to test whether positive affect and negative affect mediated the positive effects of the intervention on depressive symptoms .
RESULTS	Both positive and negative affect were significant mediators of the effects of the intervention on depressive symptoms ; however , only positive affect mediated the association between changes in physical activity and improved depressive symptoms .
CONCLUSIONS	Findings support physical activity and positive affect as key mediators of the MI treatment effect on improved mood .
CONCLUSIONS	Decreases in negative affect were also evident in the treatment group , but were not related to improved physical activity .
CONCLUSIONS	Findings may suggest the use of exercise-based interventions in conjunction with treatments that specifically target negative affective mechanisms for depression .

###24652221
BACKGROUND	Treatment with folic acid and vitamin B12 appears capable of reducing total plasma homocysteine levels ( tHcy ) , but it is unknown whether vitamin B12 alone reduces tHcy values .
BACKGROUND	In this study we investigate the effects of alternate vitamins supplementation on homocysteine levels in patients treated by diffusive and convective dialysis techniques .
METHODS	74 patients were randomized blindly into two groups of 37 subjects each .
METHODS	The first group was treated initially with vitamin B12 for 2 months and with folic acid for the following 2 months .
METHODS	The second group was treated initially with folic acid .
METHODS	A wash out period of 2 months followed the treatment in both groups .
RESULTS	Total homocysteine levels decreased in both groups following the alternate vitamins therapy and dialysis , without significant difference between diffusive and convective techniques .
RESULTS	Surprisingly , after the wash-out period , tHcy increased remarkably , regardless of the dialysis procedure used .
RESULTS	At the end of the study , folate levels showed a higher reduction with haemodialysis compared to haemodiafiltration .
RESULTS	In contrast , vitamin B12 levels showed a significant increase using diffusive haemodialysis , confirming a decisive role of membrane performance .
CONCLUSIONS	In conclusion we show for the first time that , even if total homocysteine levels decreased in both dialysis procedures , the convective techniques demonstrate a superior capacity on the reduction of tHcy levels compared to the diffusive method .
CONCLUSIONS	Moreover , the lower depletion of vitamin B12 by diffusive techniques could determine a higher reduction of folate levels , demonstrating the decisive role of the membrane performance in the treatment of this patients .

###25196930
BACKGROUND	Turning is a common activity for older people , and is one of the activities commonly associated with falls during walking .
BACKGROUND	Falls that occur while walking and turning have also been associated with an increased risk of hip fracture in older people .
BACKGROUND	Despite the importance of stability during turning , there has been little focus on identifying this impairment in at risk older people , or in evaluating interventions aiming to improve this outcome .
BACKGROUND	This study will evaluate the effectiveness of a 16 week tailored home based exercise program in older adults aged ( 50 years and above ) who were identified as having unsteadiness during turning .
METHODS	A single blind randomized controlled trial will be conducted , with assessors blind to group allocation .
METHODS	Study participants will be aged 50 years and above , living in the community and have been identified as having impaired turning ability [ outside of age and gender normal limits on the Step Quick Turn ( 180 degree turn ) task on the Neurocom Balance Master with long plate ] .
METHODS	After a comprehensive baseline assessment , those classified as having balance impairment while turning will be randomized to intervention or control group .
METHODS	The intervention group will receive a 16 week individualized balance and strength home exercise program , based on the Otago Exercise Program with additional exercises focused on improving turning ability .
METHODS	Intervention group will attend four visit to the assessment centre over 16 weeks period , for provision , monitoring , modification of the exercise and encourage ongoing participation .
METHODS	Participants in the control group will continue with their usual activities .
METHODS	All participants will be re-assessed on completion of the 16 week program .
METHODS	Primary outcome measures will be the Step Quick Turn Test and Timed-Up and Go test .
METHODS	Secondary outcomes will include other clinical measures of balance , psychological aspects of falls , incidence of falls and falls risk factors .
CONCLUSIONS	Results of this study will provide useful information for clinicians on the types of exercises to improve turning ability in older people with increased falls risk and the effectiveness of these exercises in improving outcomes .
BACKGROUND	ACTRN12613000855729 .

###25472724
BACKGROUND	Trauma such as hip fracture initiates a neurohumoral stress response that changes the balance between anabolism and catabolism resulting in muscle breakdown and reduced mobilisation .
BACKGROUND	Various studies have demonstrated a reduction in catabolism with pre-operative carbohydrate loading but only in an elective setting .
METHODS	This is a two-centre , randomised double-blinded trial in the United Kingdom .
METHODS	Sample size will be 30 patients ( approximately 15 from each centre ) .
METHODS	Randomisation will be web based using computer-generated concealed tables .
METHODS	Both participants and investigators will be blinded to group allocation .
METHODS	Participants will be > 70 years of age , cognitively intact ( Abbreviated Mental Score 7 ) , able to give informed consent , and admitted directly through the emergency department with fractured neck of femur requiring hemiarthroplasty .
METHODS	Intervention will consist of two carbohydrate drinks ( Nutricia pre-Op ) given the night before , and the morning of the surgery .
METHODS	The control will receive two placebo drinks of equal volume .
METHODS	All participants will receive standard hospital care at the discretion of the clinical team .
METHODS	The primary outcome is the difference between groups in insulin resistance calculated by a glucose tolerance test administered pre-operatively and 24 hours postoperatively .
METHODS	Secondary endpoints will be changes in muscle carbohydrate metabolism ( biopsy ) , mobility ( Cumulative Ambulation Score ) and subjective measures of tolerability .
CONCLUSIONS	This is a small-scale pilot study , investigating the benefits and tolerability of carbohydrate loading in an emergency setting in a frail elderly group with known high morbidity and mortality .
CONCLUSIONS	Positive findings will provide the basis for a larger scale study .
BACKGROUND	Current Controlled Trials ISRCTN91109766 ( 7 April 2014 ) ; NRES ref : 13/EM/0214Trial Sponsor : University of Nottingham Ref .13036 .

###25447348
OBJECTIVE	This study examined the effects of a cardiac rehabilitation ( CR ) program on functional capacity and health status ( HS ) in patients with newly implanted left ventricular assist devices ( LVADs ) .
BACKGROUND	Reduced functional capacity and HS are independent predictors of mortality in patients with heart failure .
BACKGROUND	CR improves both , and is related to improved outcomes in patients with heart failure ; however , there is a paucity of data that describe the effects of CR in patients with LVADs .
METHODS	Enrolled subjects ( n = 26 ; 7 women ; age 55 13 years ; ejection fraction 21 8 % ) completed a symptom-limited cardiopulmonary exercise test , the Kansas City Cardiomyopathy Questionnaire ( KCCQ ) , a 6-min walk test ( 6MW ) , and single-leg isokinetic strength test before 2:1 randomization to CR versus usual care .
METHODS	Subjects in the CR group underwent 18 visits of aerobic exercise at 60 % to 80 % of heart rate reserve .
METHODS	Within-group changes from baseline to follow-up were analyzed with a paired t-test , whereas an independent t-test was used to determine differences in the change between groups .
RESULTS	Within-group improvements were observed in the CR group for peak oxygen uptake ( 10 % ) , treadmill time ( 3.1 min ) , KCCQ score ( 14.4 points ) , 6MW distance ( 52.3 m ) , and leg strength ( 17 % ) .
RESULTS	Significant differences among groups were observed for KCCQ , leg strength , and total treadmill time .
CONCLUSIONS	Indicators of functional capacity and HS are improved in patients with continuous-flow LVADs who attend CR .
CONCLUSIONS	Future trials should examine the mechanisms responsible for these improvements , and if such improvements translate into improved clinical outcomes .
CONCLUSIONS	( Cardiac Rehabilitation in Patients With Continuous Flow Left Ventricular Assist Devices : Rehab VAD Trial [ RehabVAD ] ; NCT01584895 ) .

###25137863
BACKGROUND	Postoperative pain is one of the most important problems that confront surgical patients .
BACKGROUND	The aim of this work is to compare pain control using intravenous patient controlled analgesia ( PCA ) and patient controlled epidural analgesia ( PCEA ) in cirrhotic patients undergoing elective hepatic resection .
METHODS	Thirty four adult patients ASAI and II scheduled for liver resection were randomly allocated into two groups-Group ( P ) with I.V ( PCA ) with fentanyl and Group ( E ) ( PCEA ) via epidural catheter using Bubivacaine 0.125 % plus 2 microgram per ml fentanyl .
METHODS	Coagulation changes were followed and pain score was compared in both groups .
RESULTS	34 child A cirrhotic patients , undergoing liver resection were studied .
RESULTS	The demographic data were comparable in both groups .
RESULTS	There was a significant decrease in pain score in both groups during the follow up period when compared to their initial score .
RESULTS	When comparing average pain score between both groups , the PCEA group had significantly lower values .
RESULTS	The changes in prothrombin time ( PT ) , INR , and hemoglobin ( Hb ) , were significant all over the follow up period compared to their corresponding base line values .
RESULTS	2 cases needed FFP to normalize the INR for epidural removal .
RESULTS	There was no significant difference regarding postoperative nausea and vomiting ( PONV ) in both groups , no clinical manifestation suggesting epidural hematoma , and no cases were recorded to have respiratory depression .
RESULTS	There were no significant differences in patient satisfaction and ICU stay .
CONCLUSIONS	The two modalities of pain control seems to be nearly equivalent , but considering the risk of epidural catheter insertion and removal in cirrhotic patients who are further exposed to hepatectomy with subsequent additional coagulopathy , it may be wise to consider IVPCA technique as a policy for pain management in cirrhotic patient undergoing hepatectomy .

###24484450
OBJECTIVE	We studied the response to high doses of egg yolk containing antisecretory factor ( B221 , Salovum ) in young children with acute diarrhoea , presenting to the Children 's Hospital , Lahore , Pakistan .
METHODS	In a randomised , placebo-controlled trial , 36 children aged 7 to 60 months with acute diarrhoea of unknown aetiology , with mild-to-moderate dehydration , were randomised to the Salovum or placebo groups .
METHODS	Initially , 16 grams of Salovum or ordinary egg yolk ( placebo ) mixed in oral rehydration salts was given , followed by 8 g every 5 h until recovery .
METHODS	The number and consistency of stools were recorded .
RESULTS	The two groups were comparable in age , gender , duration of diarrhoea , hydration and nutritional status , although the proportion with watery stools was higher in the Salovum group ( p = 0.04 ) .
RESULTS	Reduction in the frequency of stools was seen at 7 versus 18 h ( p < 0.0001 ) and normalising of stool consistency was 10 versus 18 h , p < 0.03 ) in the Salovum and placebo groups .
RESULTS	The overall effect was 35 versus 70 h in the two groups ( p = 0.001 ) .
RESULTS	No side effects were reported .
CONCLUSIONS	High doses of AF in the form of Salovum effectively and safely reduce childhood diarrhoea of a likely broad aetiology .

###24461877
OBJECTIVE	An anabolic state can be achieved upon intravenous amino acid administration during the immediate postnatal phase despite a low energy intake .
OBJECTIVE	The optimal dosing of amino acid and energy intake has yet to be established .
OBJECTIVE	The aim was to quantify the efficacy of early initiation of parenteral lipids and increased amounts of amino acids on metabolism and protein accretion in very low birth weight infants .
METHODS	28 very low birth weight infants were randomized to receive parenteral nutrition with glucose and either 2.4 gamino acids / ( kgd ) ( control group ) , 2.4 gamino acids / ( kgd ) plus 2-3glipid / ( kgd ) ( AA + lipid group ) , or 3.6 gamino acids / ( kgd ) plus 2-3glipid / ( kgd ) ( high AA + lipid group ) from birth onward .
METHODS	On postnatal day 2 , we performed a stable isotope study with [ 1 - ( 13 ) C ] phenylalanine , [ ring-D4 ] tyrosine , [ U - ( 13 ) C6 , ( 15 ) N ] leucine , and [ methyl-D3 ] - ketoisocaproic acid to quantify intermediate amino acid metabolism .
RESULTS	The addition of lipids only had no effect on phenylalanine metabolism , whereas the addition of both lipids and additional amino acids increased the amount of phenylalanine used for protein synthesis .
RESULTS	In addition , high amino acid intake significantly increased the rate of hydroxylation of phenylalanine to tyrosine , increasing the availability of tyrosine for protein synthesis .
RESULTS	However , it also increased urea concentrations .
RESULTS	Increasing energy intake from 40 to 60kcal / ( kgd ) did not increase protein efficiency as measured by phenylalanine kinetics .
RESULTS	The leucine data were difficult to interpret due to the wide range of results and inconsistency in the data between the phenylalanine and leucine models .
CONCLUSIONS	High amino acid and energy intakes from birth onwards result in a more anabolic state in very low birth weight infants , but at the expense of higher urea concentrations , which reflects a higher amino acid oxidation .
CONCLUSIONS	Long-term outcome data should reveal whether this policy deserves routine implementation .
CONCLUSIONS	This trial was registered at www.trialregister.nl , trial number NTR1445 , name Nutritional Intervention for Preterm Infants-2 .

###25815575
OBJECTIVE	To characterize the postprandial nutrient profiles of exercise-conditioned dogs fed a supplemental carbohydrate and protein bar with or without astaxanthin from Haematococcus pluvialis immediately after exercise .
METHODS	34 exercise-conditioned adult Husky-Pointer dogs .
METHODS	The study had 2 phases .
METHODS	During phase 1 , postprandial plasma glucose concentration was determined for dogs fed a bar containing 25 % protein and 18.5 % or 37.4 % maltodextrin plus dextrin ( rapidly digestible carbohydrate ; RDC ) , or dry kibble ( 30 % protein and 0 % RDC ) immediately after exercise .
METHODS	During phase 2 , dogs were exercised for 3 days and fed a bar ( 25 % protein and 37.4 % RDC ) with ( CPA ; n = 8 ) or without ( CP ; 8 ) astaxanthin or no bar ( control ; 8 ) immediately after exercise .
METHODS	Pre - and postexercise concentrations of plasma biochemical analytes and serum amino acids were determined on days 1 and 3 .
RESULTS	Phase 1 postexercise glucose concentration was increased when dogs were provided the 37.4 % RDC bar , but not 0 % or 18.5 % RDC .
RESULTS	On day 3 of phase 2 , the CPA group had the highest pre-exercise triglyceride concentration and significantly less decline in postexercise glucose concentration than did the CP and control groups .
RESULTS	Mean glucose concentration for the CP and CPA groups was significantly higher than that for the control group between 15 and 60 minutes after bar consumption .
RESULTS	Compared to immediately after exercise , branched-chain amino acid , tryptophan , leucine , and threonine concentrations 15 minutes after exercise were significantly higher for the CP and CPA groups , but were lower for the control group .
CONCLUSIONS	Dogs fed a bar with 37.4 % RDCs and 25 % protein immediately after exercise had increased blood nutrient concentrations for glycogen and protein synthesis , compared with control dogs .

###24404992
BACKGROUND	Anger and aggression among adults with intellectual disability ( ID ) are associated with a range of adverse consequences for their well-being and that of their family or staff carers .
BACKGROUND	The aims were to evaluate the effectiveness of an anger management intervention for adults with mild to moderate ID and to evaluate the costs of the intervention and its impact on health and social care resource use .
BACKGROUND	This paper is concerned with the latter aim .
METHODS	A cluster-randomised controlled trial was conducted involving day services for adults with ID in Scotland , England and Wales .
METHODS	Incremental costs of delivering the intervention and its impact on subsequent total health and social care package costs were calculated .
METHODS	Full data comparing costs between baseline and follow-up 10 months later were collected for 67 participants in the intervention arm and 62 participants in the control arm .
METHODS	Cost differences between the groups at follow-up , adjusted for baseline levels , were calculated using non-parametric bootstrapping controlling for clustering .
RESULTS	The mean hourly excess cost of intervention over treatment as usual was 12.34 .
RESULTS	A mean adjusted cost difference of 22.46 per person per week in favour of the intervention group was found but this was not statistically significant .
CONCLUSIONS	The baseline-adjusted cost difference at follow-up would result in a fairly immediate compensation for the excess costs of intervention , provided the difference is not a statistical artefact .
CONCLUSIONS	Further research is needed to clarify the extent to which it might represent a real saving in service support costs .

###24906822
BACKGROUND	Data on risk associated with 24-hour ambulatory diastolic ( DBP24 ) versus systolic ( SBP24 ) blood pressure are scarce .
RESULTS	We recorded 24-hour blood pressure and health outcomes in 8341 untreated people ( mean age , 50.8 years ; 46.6 % women ) randomly recruited from 12 populations .
RESULTS	We computed hazard ratios ( HRs ) using multivariable-adjusted Cox regression .
RESULTS	Over 11.2 years ( median ) , 927 ( 11.1 % ) participants died , 356 ( 4.3 % ) from cardiovascular causes , and 744 ( 8.9 % ) experienced a fatal or nonfatal cardiovascular event .
RESULTS	Isolated diastolic hypertension ( DBP2480 mmHg ) did not increase the risk of total mortality , cardiovascular mortality , or stroke ( HRs1 .54 ; P0 .18 ) , but was associated with a higher risk of fatal combined with nonfatal cardiovascular , cardiac , or coronary events ( HRs1 .75 ; P0 .0054 ) .
RESULTS	Isolated systolic hypertension ( SBP24130 mmHg ) and mixed diastolic plus systolic hypertension were associated with increased risks of all aforementioned end points ( P0 .0012 ) .
RESULTS	Below age 50 , DBP24 was the main driver of risk , reaching significance for total ( HR for 1-SD increase , 2.05 ; P = 0.0039 ) and cardiovascular mortality ( HR , 4.07 ; P = 0.0032 ) and for all cardiovascular end points combined ( HR , 1.74 ; P = 0.039 ) with a nonsignificant contribution of SBP24 ( HR0 .92 ; P0 .068 ) ; above age 50 , SBP24 predicted all end points ( HR1 .19 ; P0 .0002 ) with a nonsignificant contribution of DBP24 ( 0.96 HR1 .14 ; P0 .10 ) .
RESULTS	The interactions of age with SBP24 and DBP24 were significant for all cardiovascular and coronary events ( P0 .043 ) .
CONCLUSIONS	The risks conferred by DBP24 and SBP24 are age dependent .
CONCLUSIONS	DBP24 and isolated diastolic hypertension drive coronary complications below age 50 , whereas above age 50 SBP24 and isolated systolic and mixed hypertension are the predominant risk factors .

###24708204
OBJECTIVE	To evaluate efficacy and safety of subcutaneous ( SC ) and intravenous ( IV ) abatacept and background methotrexate ( MTX ) in Japanese patients with rheumatoid arthritis ( RA ) and inadequate response to MTX ( MTX-IR ) .
METHODS	Double-dummy , double-blind study ( NCT01001832 ) ; 118 adults with 10 swollen joints , 12 tender joints and C-reactive protein ( CRP ) 0.8 mg/dL randomized 1:1 to SC abatacept ( 125 mg weekly ) with IV loading ( 10 mg/kg on Day 1 ) , or IV abatacept ( 10 mg/kg monthly ) for 169 days , both also receiving MTX ( 6-8 mg/week ) .
METHODS	Primary endpoint was Day 169 American College of Rheumatology ( ACR ) 20 response ; other efficacy endpoints , safety and immunogenicity were assessed .
RESULTS	Similar proportions of patients achieved ACR20 responses at Day 169 with SC ( 91.5 % [ 95 % CI 81.3 , 97.2 ] ) and IV abatacept ( 83.1 % [ 71.0 , 91.6 ] ) .
RESULTS	ACR50/70 responses , adjusted mean changes from baseline in Health Assessment Questionnaire-Disability Index scores and remission rates ( 28-joint Disease Activity Score [ CRP ] < 2.6 ) were also comparable between groups .
RESULTS	Serious adverse event frequencies ( 5.1 % vs. 3.4 % ) were similar with both formulations .
RESULTS	One patient per group tested seropositive for immunogenicity .
RESULTS	Weekly SC abatacept dosing achieved mean serum concentrations > 10 g/mL ( minimum therapeutic target ) .
CONCLUSIONS	SC abatacept demonstrated comparable efficacy and safety to IV abatacept , with low immunogenicity rates , in MTX-IR Japanese patients with RA .

###24474176
OBJECTIVE	To measure the change in the minimum alveolar concentration of isoflurane ( EtISO ) associated with epidural nalbuphine and the postoperative analgesic requirements in dogs after ovariohysterectomy .
METHODS	Twenty four healthy female dogs were randomly assigned to receive saline or nalbuphine at 0.3 or 0.6 mg/kg ( n = 8 for each group ) administered via lumbosacral epidural catheter introduced cranially into the epidural canal .
METHODS	Changes in heart and respiratory rates and arterial blood pressure during surgery were recorded along with the corresponding EtISO .
METHODS	Immediately after tracheal extubation , analgesia , sedation , heart rate , respiratory rate , and arterial blood pressure were measured at predetermined intervals and every 60 min thereafter until the first rescue analgesic .
RESULTS	A significant decrease in EtISO was associated with epidural nalbuphine at 0.3 mg/kg ( 26.3 % ) and 0.6 mg/kg ( 38.4 % ) but not with saline in ovariohysterectomized dogs .
RESULTS	In the postoperative period , VAS and Colorado analgesic scores were lower for the dogs that received the higher nalbuphine dose , which only required supplemental analgesia 10 h following its administration , compared with dogs that received the lower dose .
CONCLUSIONS	Epidural nalbuphine significantly reduces the intra-operative isoflurane requirement and provides prolonged postoperative analgesia after ovariohysterectomy in dogs .

###25222850
BACKGROUND	Parental smoking is associated with an increased risk of smoking among youth .
BACKGROUND	Epidemiological research has shown that parental smoking cessation can attenuate this risk .
BACKGROUND	This study examined whether telephone counselling for parents and subsequent parental smoking cessation affect smoking-related cognitions and smoking initiation among children of smoking parents .
METHODS	Data of a two-arm randomized controlled trial were used in which 512 smoking parents were recruited into cessation support through their children 's primary schools .
METHODS	After the baseline assessment , smoking parents were randomly assigned to tailored telephone counselling or a standard self-help brochure .
METHODS	Parental cessation was measured as 6-month prolonged abstinence at the 12-month follow-up .
METHODS	Children 's smoking-related cognitions and smoking initiation were examined at 3-month , 12-month , and 30-month follow-up .
RESULTS	No statistical evidence was found that children of parents who received telephone counselling tailored to smoking parents or children of parents who achieved prolonged abstinence differ in smoking-related cognitions ( i.e. , smoking outcome expectancies , perceived safety of smoking , self-efficacy to refrain from smoking , susceptibility to smoking ) or smoking initiation rate on any follow-up assessment .
CONCLUSIONS	This study is the first to examine the effects of an evidence-based smoking cessation treatment for parents and treatment-induced parental smoking cessation on cognitive and behavioural outcomes among children .
CONCLUSIONS	Although descriptive statistics showed lower smoking initiation rates among children of parents who achieved prolonged abstinence , there was no statistical evidence that telephone counselling tailored to parents or treatment-induced parental smoking cessation affects precursors of smoking or smoking initiation among youth .

###26281285
BACKGROUND	Increasing rates of obesity and associated diseases and their consequences make the implementation of preventive and counteracting measures necessary .
BACKGROUND	The aim of this study was the examination of the long-term effects of financial incentives on weight loss in obese patients and the identification of influencing factors .
METHODS	700 obese patients were randomly assigned to one of three study conditions : For reaching a pre-defined target weight within 4 months they were rewarded with Euro 150 , Euro 300 or not at all .
METHODS	The effect of the incentives on weight loss in different subgroups was compared .
METHODS	After 18 months , other possible influences on weight loss were analyzed by comparing responders and non-responders .
RESULTS	Financial rewards led to significant weight loss in all subgroups , whereupon the height of the incentive only mattered in some .
RESULTS	After 22 months , for several subgroups , the incentive 's effect was still visible .
RESULTS	Furthermore , responders showed more healthy behaviour , were better informed and reported more social support .
CONCLUSIONS	Especially for patient groups who do not lose weight in orthodox treatments alone , financial incentives can be an effective supplement .
CONCLUSIONS	In addition it became clear that this kind of reward programme can be implemented area-wide .

###24889086
OBJECTIVE	Older adults have increased visual impairment , including refractive blur from presbyopic multifocal spectacle corrections , and are less able to extract visual information from the environment to plan and execute appropriate stepping actions ; these factors may collectively contribute to their higher risk of falls .
OBJECTIVE	The aim of this study was to examine the effect of refractive blur and target visibility on the stepping accuracy and visuomotor stepping strategies of older adults during a precision stepping task .
METHODS	Ten healthy , visually normal older adults ( mean age 69.45.2 years ) walked up and down a 20m indoor corridor stepping onto selected high and low contrast targets while viewing under three visual conditions : best-corrected vision , +2.00 DS and +3.00 DS blur ; the order of blur conditions was randomised between participants .
METHODS	Stepping accuracy and gaze behaviours were recorded using an eyetracker and a secondary hand-held camera .
RESULTS	Older adults made significantly more stepping errors with increasing levels of blur , particularly exhibiting under-stepping ( stepping more posteriorly ) onto the targets ( p < 0.05 ) , while visuomotor stepping strategies did not significantly alter .
RESULTS	Stepping errors were also significantly greater for the low compared to the high contrast targets and differences in visuomotor stepping strategies were found , including increased duration of gaze and increased interval between gaze onset and initiation of the leg swing when stepping onto the low contrast targets .
CONCLUSIONS	These findings highlight that stepping accuracy is reduced for low visibility targets , and for high levels of refractive blur at levels typically present in multifocal spectacle corrections , despite significant changes in some of the visuomotor stepping strategies .
CONCLUSIONS	These findings highlight the importance of maximising the contrast of objects in the environment , and may help explain why older adults wearing multifocal spectacle corrections exhibit an increased risk of falling .

###24338990
BACKGROUND	Chemoradiotherapy has become the standard of care for head and neck squamous cell carcinoma ; however , those patients often experience multiple treatment-related symptoms or symptom clusters .
BACKGROUND	Two symptom clusters have been identified for this population .
BACKGROUND	Little is known about the risk factors of these symptom clusters .
METHODS	Subjects comprised 684 patients who were treated with concurrent chemoradiotherapy in a phase 3 randomized clinical trial .
METHODS	This trial compared standard fractionation radiotherapy to accelerated fractionation radiotherapy .
METHODS	Symptom clusters were evaluated at the end of the first and the second cycle of chemotherapy , and 3 months after the start of radiotherapy .
METHODS	Mixed-effect modeling was used to observe risk factors for symptom clusters .
RESULTS	Race and education were independent predictors for the head and neck cluster , whereas sex and history of tobacco use were independent predictors for the gastrointestinal cluster .
RESULTS	Primary cancer site was only significant for the head and neck cluster when other factors were not controlled : patients with oropharyngeal cancer had more severe symptoms in the head and neck clusters than did patients with laryngeal cancer .
RESULTS	In addition , patients receiving accelerated fractionation radiotherapy experienced more symptoms of radiomucositis , pain , and nausea at 3 months after the start of radiotherapy than those receiving standard fractionation radiotherapy .
CONCLUSIONS	Demographic characteristics were more predictive to symptom clusters , whereas clinical characteristics , such as cancer site and treatment arms , were more significant for individual symptoms .
CONCLUSIONS	Knowing the risk factors will enhance the capability of clinicians to evaluate patients ' risk of severe symptom clusters and to personalize management strategies .

###24434951
OBJECTIVE	To determine the physiological impact of exposure to weight stigma by examining alterations in salivary cortisol among lean and overweight women .
METHODS	Participants were 123 lean and overweight adult women ( mean body mass index = 26.99 [ 7.91 ] kg/m ( 2 ) ) .
METHODS	Participants ' salivary cortisol was assessed both before and after either a weight stigmatizing or a neutral video .
METHODS	Participants completed self-report measures of mood and reactions to the video .
METHODS	Height and weight were obtained at the conclusion of the study .
RESULTS	Participants in the stigmatizing condition exhibited significantly greater cortisol reactivity when compared with those in the neutral condition , irrespective of weight status ( Pillai trace = 0.077 ; F ( 1,85 ) = 7.22 , p = .009 ) .
RESULTS	Lean and overweight women in the stigmatizing condition were equally likely to find the video upsetting and were equally likely to report that they would rather not see obese individuals depicted in a stigmatizing manner in the media .
CONCLUSIONS	Exposure to weight-stigmatizing stimuli was associated with greater cortisol reactivity among lean and overweight women .
CONCLUSIONS	These findings highlight the potentially harmful physiological consequences of exposure to weight stigma .

###24883300
BACKGROUND	This study aimed to compare the effects of rectal midazolam addition after applying bupivacaine and caudal anesthesia on postoperative analgesia time , the need for additional analgesics , postoperative recovery , and sedation and to find out its adverse effects in children having lower abdominal surgery .
METHODS	40 children between 2 and 10 years of ASA I-II were randomized , and they received caudal anesthesia under general anesthesia .
METHODS	Patients underwent the application of caudal block in addition to saline and 1 mL/kg bupivacaine 0.25 % .
METHODS	In the postoperative period , Group C ( n = 20 ) was given 5 mL saline , and Group M ( n = 20 ) was given 0.30 mg/kg rectal midazolam diluted with 5 mL saline .
METHODS	Sedation scale and postoperative pain scale ( CHIPPS ) of the patients were evaluated .
METHODS	The patients were observed for their analgesic need , first analgesic time , and adverse effects for 24 hours .
RESULTS	Demographic and hemodynamic data of the two groups did not differ .
RESULTS	Postoperative sedation scores in both groups were significantly lower compared with the preoperative period .
RESULTS	There was no significant difference between the groups in terms of sedation and sufficient analgesia .
CONCLUSIONS	We conclude that caudal anesthesia provided sufficient analgesia in peroperative and postoperative periods , and rectal midazolam addition did not create any differences .
CONCLUSIONS	This trial is registered with ClinicalTrials.gov NCT02127489 .

###24359098
CONCLUSIONS	Bleeding control with epinephrine hydrochloride-soaked cotton packing in the maxillary sinus after canine fossa puncture ( CFP ) during operation is a simple method for reducing complications , especially those associated with blood leakage from the maxillary sinus into the subcutaneous tissue .
OBJECTIVE	Although CFP is a useful method for extensive maxillary sinus disease , complications can occur associated with nerve injuries or mucosal bleeding .
OBJECTIVE	We evaluated whether maxillary sinus packing with epinephrine hydrochloride-soaked cotton pledgets would reduce complications after CFP .
METHODS	Patients who met the inclusion criteria were randomly allocated to groups 1 ( packing ) and 2 ( no packing ) .
METHODS	Patients underwent unilateral or bilateral CFP .
METHODS	We compared the disease entities , complication incidence , and average symptom duration between the groups .
RESULTS	A total of 57 patients were included .
RESULTS	Group 1 underwent 36 CFPs , and complications occurred in 20 sides of 17 patients .
RESULTS	Group 2 had 39 CFPs , and 20 patients experienced complications in 26 sides .
RESULTS	The total number of complications was 40 and 73 in groups 1 and 2 , respectively .
RESULTS	Incidence or duration of facial , dental , or gum numbness did not differ between groups .
RESULTS	Tingling sensation , facial pain , facial swelling , and bruising showed significantly lower occurrence rates and shorter duration in group 1 .

###24740588
OBJECTIVE	Coffee consumption has been reported to decrease oxidative damage in peripheral white blood cells ( WBC ) .
OBJECTIVE	However , effects on the level of spontaneous DNA strand breaks , a well established marker of health risk , have not been specifically reported yet .
OBJECTIVE	We analyzed the impact of consuming a dark roast coffee blend on the level of spontaneous DNA strand breaks .
METHODS	Healthy men ( n = 84 ) were randomized to consume daily for 4 weeks either 750 ml of fresh coffee brew or 750 ml of water , subsequent to a run in washout phase of 4 weeks .
METHODS	The study coffee was a blend providing high amounts of both caffeoylquinic acids ( 10.18 0.33 mg/g ) and the roast product N-methylpyridinium ( 1.10 0.05 mg/g ) .
METHODS	Before and after the coffee/water consumption phase , spontaneous strand breaks were determined by comet assay .
RESULTS	At baseline , both groups exhibited a similar level of spontaneous DNA strand breaks .
RESULTS	In the intervention phase , spontaneous DNA strand breaks slightly increased in the control ( water only ) group whereas they significantly decreased in the coffee group , leading to a 27 % difference within both arms ( p = 0.0002 ) .
RESULTS	Food frequency questionnaires indicated no differences in the overall diet between groups , and mean body weight during the intervention phases remained stable .
RESULTS	The consumption of the study coffee substantially lowered the level of spontaneous DNA strand breaks in WBC .
CONCLUSIONS	We conclude that regular coffee consumption contributes to DNA integrity .

###24390799
BACKGROUND	Clinical trials of radiation after radical cystectomy ( RC ) and chemotherapy for bladder cancer are in development , but inclusion and stratification factors have not been clearly established .
BACKGROUND	In this study , the authors evaluated and refined a published risk stratification for locoregional failure ( LF ) by applying it to a multicenter patient cohort .
METHODS	The original stratification , which was developed using a single-institution series , produced 3 subgroups with significantly different LF risk based on pathologic tumor ( pT ) classification and the number of lymph nodes identified .
METHODS	This model was then applied to patients in Southwest Oncology Group ( SWOG ) 8710 , a randomized trial of RC with or without chemotherapy .
METHODS	LF was defined as any pelvic failure before or within 3 months of distant failure .
RESULTS	Patients in the development cohort and the SWOG cohort had significantly different baseline characteristics .
RESULTS	The original risk model was not fully validated in the SWOG cohort , because lymph node yield was not as strongly associated with LF as in the development cohort .
RESULTS	Regression analysis indicated that margin status could improve the model .
RESULTS	A revised stratification using pT classification , margin status , and the number of lymph nodes identified produced 3 subgroups with significantly different LF risk in both cohorts : low risk ( pT2 ) , intermediate risk ( pT3 with negative margins AND 10 lymph nodes identified ) , and high risk ( pT3 with positive margins OR < 10 lymph nodes identified ) with 5-year LF rates of 8 % , 20 % , and 41 % , respectively , in the SWOG cohort and 8 % , 19 % , and 41 % , respectively , in the development cohort .
CONCLUSIONS	A model incorporating pT classification , margin status , and the number of lymph nodes identified stratified LF risk in 2 different RC populations and may inform the design of future trials .

###24489014
OBJECTIVE	Our primary purpose was to evaluate the efficacy of the high-potency 2C-adrenoceptor antagonist ORM-12741 in the attenuation of a cold-induced reduction in finger blood flow and temperature in patients with RP secondary to SSc .
OBJECTIVE	Secondary objectives were to assess safety and tolerability .
METHODS	This was a phase IIa , randomized , double-blind , crossover , single-dose , placebo-controlled , single-centre study .
METHODS	Patients attended five times : initial screening , treatment visits 1-3 ( each at least 1 week apart ) and 1-2 weeks after the last treatment .
METHODS	At each treatment visit , each subject received a single oral dose of 30 mg or 100 mg of ORM-12741 or placebo .
METHODS	Thirty minutes later the subject underwent a cold challenge .
METHODS	Blood flow to the fingers was assessed by three methods [ temperature by probe , laser Doppler imaging ( LDI ) and infrared thermography ] performed before , during and after the cold challenge .
RESULTS	Twelve patients ( 10 female , mean age 58 years ) were included .
RESULTS	The area under the rewarming curve ( LDI ) of the right index finger ( arbitrary flux units time ) was lower for both 30 mg ( P = 0.043 ) and 100 mg ( P = 0.025 ) of ORM-12741 compared with placebo , indicating delayed reperfusion .
RESULTS	The time to 70 % temperature recovery ( middle finger probe ) was longer with active than placebo treatment : mean ( s.d. ) values for placebo , 30 mg of ORM-12741 and 100 mg of ORM-12741 were 21.4 min ( 12.4 ) , 25.7 min ( 12.2 ) and 26.9 min ( 13.9 ) , respectively .
RESULTS	Overall ORM-12741 was well tolerated .
CONCLUSIONS	ORM-12741 did not expedite recovery from a cold challenge in the fingers of patients with SSc .
BACKGROUND	https://www.clinicaltrialsregister.eu/; no. 2010-024005-13 .

###25409545
BACKGROUND	Approximal surfaces are a challenge to caries lesions control .
BACKGROUND	Silver diamine fluoride ( SDF ) is a simple,low-cost and promisor intervention for arresting caries lesions , but it has never been tested on approximal surfaces .
BACKGROUND	Our aim is to evaluate the efficacy and cost-efficacy of SDF in arresting initial lesions compared to resin infiltration and exclusively flossing ( control group ) .
BACKGROUND	Our second aim is to assess discomfort and satisfaction regarding interventions .
METHODS	This is a randomized clinical trial , double-blinded , placebo-controlled study .
METHODS	Children/adolescents presenting at least one approximal initial caries lesion in primary molars/permanent premolars and molars will be included .
METHODS	Surfaces with advanced dentine lesions identified by radiography and participants who refuse to participate or present negative behaviors will be excluded .
METHODS	A minimum sample size of 504 surfaces will be required for each subgroup .
METHODS	Individuals will be randomly allocated in three groups of interventions : SDF , resin infiltration , and control group .
METHODS	Depending on the allocation , the patients will receive the active treatment and respective placebo therapies .
METHODS	All patients will be oriented to daily flossing the included surfaces .
METHODS	Our primary outcome will be caries progression by clinical and radiographic examinations .
METHODS	Appointments will be timed and costs of materials will be considered to calculate cost-efficacy .
METHODS	Patient discomfort will be assessed after interventions .
METHODS	Parent and patient satisfaction with the treatment will be collected after treatment and in the last follow-up visit .
METHODS	Individuals will be assessed at 1 and 3 months after treatment to evaluate dental biofilm and at 6 , 12 , and 24 months to assess caries progression by visual examination and/or radiography .
METHODS	Multilevel analyses will be used to verify if the type of treatment influenced on the tested outcomes .
METHODS	Costs will be compared and analyses of cost-efficacy will be performed .
METHODS	Poisson analysis will test the association between intervention and reported discomfort and satisfaction .
CONCLUSIONS	Our hypothesis is that SDF is the most cost-efficacious option from all tested interventions .
CONCLUSIONS	If our hypothesis is confirmed , the use of SDF in private and public contexts could represent an easier and effective option in the treatment of enamel approximal caries in children/adolescents .
BACKGROUND	ClinicalTrials.gov ( NCT01477385 ) , Initial release : 11/16/2011 : last update : 06/02/2014 .

###24726066
BACKGROUND	There is insufficient evidence to support use of occupational therapy interventions for patients with Parkinson 's disease .
BACKGROUND	We aimed to assess the efficacy of occupational therapy in improving daily activities of patients with Parkinson 's disease .
METHODS	We did a multicentre , assessor-masked , randomised controlled clinical trial in ten hospitals in nine Dutch regional networks of specialised health-care professionals ( ParkinsonNet ) , with assessment at 3 months and 6 months .
METHODS	Patients with Parkinson 's disease with self-reported difficulties in daily activities were included , along with their primary caregivers .
METHODS	Patients were randomly assigned ( 2:1 ) to the intervention or control group by a computer-generated minimisation algorithm .
METHODS	The intervention consisted of 10 weeks of home-based occupational therapy according to national practice guidelines ; control individuals received usual care with no occupational therapy .
METHODS	The primary outcome was self-perceived performance in daily activities at 3 months , assessed with the Canadian Occupational Performance Measure ( score 1-10 ) .
METHODS	Data were analysed using linear mixed models for repeated measures ( intention-to-treat principle ) .
METHODS	Assessors monitored safety by asking patients about any unusual health events during the preceding 3 months .
METHODS	This trial is registered with ClinicalTrials.gov , NCT01336127 .
RESULTS	Between April 14 , 2011 , and Nov 2 , 2012 , 191 patients were randomly assigned to the intervention group ( n = 124 ) or the control group ( n = 67 ) .
RESULTS	117 ( 94 % ) of 124 patients in the intervention group and 63 ( 94 % ) of 67 in the control group had a participating caregiver .
RESULTS	At baseline , the median score on the Canadian Occupational Performance Measure was 43 ( IQR 35-50 ) in the intervention group and 44 ( 38-50 ) in the control group .
RESULTS	At 3 months , these scores were 58 ( 50-64 ) and 46 ( 46-66 ) , respectively .
RESULTS	The adjusted mean difference in score between groups at 3 months was in favour of the intervention group ( 12 ; 95 % CI 08-16 ; p < 00001 ) .
RESULTS	There were no adverse events associated with the study .
CONCLUSIONS	Home-based , individualised occupational therapy led to an improvement in self-perceived performance in daily activities in patients with Parkinson 's disease .
CONCLUSIONS	Further work should identify which factors related to the patient , environmental context , or therapist might predict which patients are most likely to benefit from occupational therapy .
BACKGROUND	Prinses Beatrix Spierfonds and Parkinson Vereniging .

###25465191
BACKGROUND	The UKW3 trial compared biopsy/pre-operative chemotherapy versus immediate nephrectomy and afforded the opportunity to examine the influence of percutaneous retroperitoneal biopsy and other factors on local and distant relapse of Wilms tumour ( WT ) .
METHODS	Patients with unilateral WT ( stages I-IV ) excluding metachronous relapse or early progressive disease were eligible .
METHODS	Metastatic and ` inoperable ' tumours were biopsied electively .
METHODS	` Local ' was defined as relapse within the abdomen , except for liver metastases considered as ` distant ' relapse , together with other haematogenous routes .
METHODS	Uni - and multivariable analyses estimated the risk factors for relapse .
RESULTS	Overall , 285/635 ( 44.9 % ) patients had a biopsy .
RESULTS	With a median follow-up of 10.1 years , 35 ( 5.5 % ) patients experienced a ` local ' , 15 a combined ( 2.4 % ) and 60 ( 9.4 % ) a ` distant ' relapse .
RESULTS	On univariate analysis , biopsy , anaplasia and tumour size were associated with an increased risk of local relapse .
RESULTS	On multivariable analysis , anaplasia and tumour size remained significant for local relapse whereas the elevated risk of biopsy ( hazards ratio ( HR ) = 1.80 : 95 % confidence interval ( CI ) 0.97-3 .32 , p = 0.060 ) was marginal .
RESULTS	Age , anaplasia , tumour size , lymph nodes metastases and stage , but not biopsy , were individually associated with increased risk of distant relapse but only age and anaplasia remained significant following multivariable analysis .
CONCLUSIONS	The UKW3 trial provides some reassurance that biopsy should not automatically lead to ` upstaging ' of WT .
CONCLUSIONS	Further assessment of this controversial area is required .
CONCLUSIONS	Comparison of local relapse rates in a multinational trial in which the United Kingdom ( UK ) continued the practice of routinely biopsying all patients in contrast to the standard European approach will afford this opportunity and is planned .

###25154844
OBJECTIVE	To evaluate the usefulness and safety of bronchoscopy by the laryngeal mask airway ( LMA ) compared with by nose and by mouth .
METHODS	Between April 2009 and Dec 2012 , we prospectively studied 150 analgesia brochoscopy in the operating theater of the our hospital .
METHODS	All the patients were randomly assigned by computer to LMA group , non-LMA by nose group ( NLBN ) and non-LMA by mouth group ( NLBM ) according the way of bronchoscopy .
METHODS	Each group had 50 cases .
METHODS	We recorded the time of bronchoscopy just through subglottic , total operation time , the times of blood oxygen less than 80 % so as to suspend procedure and so on .
RESULTS	Intergroup comparisons showed no difference in gender , age , and the successful rate of biopsy ( P > 0.05 ) .
RESULTS	The time of bronchoscopy just through subglottic in LMA group was lower than that in NLBN group and in NLBM group significantly ( P < 0.01 ) , and no difference between two latter groups ( P > 0.05 ) .
RESULTS	Also , total operation time of LMA group was higher than that of others ( P < 0.05 ) , but no difference between the latter two groups .
RESULTS	There were 18 cases in NLBN group and 15 cases in NLBM group respectively , which were suspended procedure during operation due to low oxygen , and the difference did not reach statistical sense ( P > 0.05 ) .
RESULTS	There were 19 patients presented with nasal discomfort after operations in NLBN Group .
RESULTS	The patients in all the three groups had no bad memory or fear , and the acceptance rate of reoperation was all 100 % .
RESULTS	In general , as to the cases of the patients who presented with pharyngeal discomfort and abnormal pronunciation , there was significance difference between LMA Group and NLBN Group and also between LMA Group and NLBM Group , while the difference between NLBN Group and NLBM Group was not statistically significan .
CONCLUSIONS	The use of the LMA during FFB is safe , provides excellent patient comfort , reduces the time of bronchoscopy just through subglottic so as to decrease the total operation time , and is better to control the situation of patient in operation .

###26124486
OBJECTIVE	We investigated whether thymidylate synthase ( TS ) expression is a predictive marker for the clinical outcome of pemetrexed/cisplatin in patients with nonsquamous non-small-cell lung cancer .
METHODS	Eligible patients were tested for TS expression by immunohistochemistry and stratified into either a TS-negative or a TS-positive group .
METHODS	After stratification , patients in each group were randomly assigned ( 1:1 ratio ) to receive either pemetrexed/cisplatin or gemcitabine/cisplatin for a maximum of six cycles until disease progression .
METHODS	The primary end point was evaluation of the interaction between TS groups and treatment allocation for objective response rate .
RESULTS	Of 321 enrolled patients with nonsquamous non-small-cell lung cancer , 315 received at least one dose of study chemotherapy and were analyzed .
RESULTS	By investigator assessment , response rates were 47 % for the pemetrexed/cisplatin arm and 21 % for the gemcitabine/cisplatin arm in the TS-negative group and 40 % and 39 % , respectively , for the TS-positive group ( interaction P = .0084 ) .
RESULTS	By independent reviewers , response rates of pemetrexed/cisplatin and gemcitabine/cisplatin were 39 % and 21 % , respectively , in the TS-negative group and 40 % and 48 % in the TS-positive group ( interaction P = .0077 ) .
RESULTS	The median progression-free survival times for the pemetrexed/cisplatin and the gemcitabine/cisplatin arms were 6.4 and 5.5 months , respectively , in the TS-negative group and 5.9 and 5.3 months in the TS-positive group ( interaction P = .07 ) .
CONCLUSIONS	With regard to response rate and progression-free survival , pemetrexed/cisplatin was superior to gemcitabine/cisplatin in the TS-negative group but not in the TS-positive group , indicative of TS expression as a potential predictive marker .
CONCLUSIONS	Additional prospective studies involving larger cohorts are warranted to confirm the predictive role of TS expression .

###24220660
BACKGROUND	It is difficult to foster research utilization among allied health professionals ( AHPs ) .
BACKGROUND	Tailored , multifaceted knowledge translation ( KT ) strategies are now recommended but are resource intensive to implement .
BACKGROUND	Employers need effective KT solutions but little is known about ; the impact and viability of multifaceted KT strategies using an online KT tool , their effectiveness with AHPs and their effect on evidence-based practice ( EBP ) decision-making behavior .
BACKGROUND	The study aim was to measure the effectiveness of a multifaceted KT intervention including a customized KT tool , to change EBP behavior , knowledge , and attitudes of AHPs .
METHODS	This is an evaluator-blinded , cluster randomized controlled trial conducted in an Australian community-based cerebral palsy service .
METHODS	135 AHPs ( physiotherapists , occupational therapists , speech pathologists , psychologists and social workers ) from four regions were cluster randomized ( n = 4 ) , to either the KT intervention group ( n = 73 AHPs ) or the control group ( n = 62 AHPs ) , using computer-generated random numbers , concealed in opaque envelopes , by an independent officer .
METHODS	The KT intervention included three-day skills training workshop and multifaceted workplace supports to redress barriers ( paid EBP time , mentoring , system changes and access to an online research synthesis tool ) .
METHODS	Primary outcome ( self - and peer-rated EBP behavior ) was measured using the Goal Attainment Scale ( individual level ) .
METHODS	Secondary outcomes ( knowledge and attitudes ) were measured using exams and the Evidence Based Practice Attitude Scale .
RESULTS	The intervention group 's primary outcome scores improved relative to the control group , however when clustering was taken into account , the findings were non-significant : self-rated EBP behavior [ effect size 4.97 ( 95 % CI -10.47 , 20.41 ) ( p = 0.52 ) ] ; peer-rated EBP behavior [ effect size 5.86 ( 95 % CI -17.77 , 29.50 ) ( p = 0.62 ) ] .
RESULTS	Statistically significant improvements in EBP knowledge were detected [ effect size 2.97 ( 95 % CI 1.97 , 3.97 ( p < 0.0001 ) ] .
RESULTS	Change in EBP attitudes was not statistically significant .
CONCLUSIONS	Improvement in EBP behavior was not statistically significant after adjusting for cluster effect , however similar improvements from peer-ratings suggest behaviorally meaningful gains .
CONCLUSIONS	The large variability in behavior observed between clusters suggests barrier assessments and subsequent KT interventions may need to target subgroups within an organization .
BACKGROUND	Registered on the Australian New Zealand Clinical Trials Registry ( ACTRN12611000529943 ) .

###24929936
BACKGROUND	Functional dysphonias are commonly associated with reduced treatment attendance leading to variable treatment outcomes .
BACKGROUND	Preliminary research has proposed that intensive treatment may improve client adherence and outcomes ; however , further research into the application of intensive models in functional dysphonia in comparison with standard intensity models is warranted .
OBJECTIVE	The present study evaluated the impact of intensive and standard treatments on functional , well-being , and service outcome measures in clients with functional dysphonia .
METHODS	Participants with a functional dysphonia were randomly allocated to one of two treatment groups : ( 1 ) intensive treatment ( n = 7 ) or ( 2 ) standard treatment ( n = 9 ) .
METHODS	Participants completed the voice handicap index ( VHI ) and the Australian therapy outcome measures voice assessment ( conducted by a blinded assessor ) before and after treatment and 4weeks after treatment .
METHODS	Satisfaction questionnaires were completed after treatment and data pertaining to attendance and duration of intervention were collected throughout treatment .
METHODS	In addition to a vocal hygiene education session , all participants received a total of 8hours of treatment ; intensive treatment consisted of four 1-hour treatment sessions per week over 2weeks , whereas the standard group received one 1-hour treatment session per week over 8weeks .
RESULTS	High satisfaction and statistically significant improvements on the VHI ratings were found after treatment in the intensive group .
RESULTS	Significantly greater attendance rates were found in the intensive group .
RESULTS	Intensive treatment is a potentially viable service delivery option for functional dysphonia and warrants further larger scale investigation .

###25208233
BACKGROUND	Previous studies show a prolongation of activated partial thromboplastin time and prothrombin time in healthy volunteers after treatment with sugammadex .
BACKGROUND	The authors investigated the effect of sugammadex on postsurgical bleeding and coagulation variables .
METHODS	This randomized , double-blind trial enrolled patients receiving thromboprophylaxis and undergoing hip or knee joint replacement or hip fracture surgery .
METHODS	Patients received sugammadex 4 mg/kg or usual care ( neostigmine or spontaneous recovery ) for reversal of rocuronium - or vecuronium-induced neuromuscular blockade .
METHODS	The Cochran-Mantel-Haenszel method , stratified by thromboprophylaxis and renal status , was used to estimate relative risk and 95 % confidence interval ( CI ) of bleeding events with sugammadex versus usual care .
METHODS	Safety was further evaluated by prespecified endpoints and adverse event reporting .
RESULTS	Of 1,198 patients randomized , 1,184 were treated ( sugammadex n = 596 , usual care n = 588 ) .
RESULTS	Bleeding events within 24 h ( classified by an independent , blinded Adjudication Committee ) were reported in 17 ( 2.9 % ) sugammadex and 24 ( 4.1 % ) usual care patients ( relative risk [ 95 % CI ] , 0.70 [ 0.38 to 1.29 ] ) .
RESULTS	Compared with usual care , increases of 5.5 % in activated partial thromboplastin time ( P < 0.001 ) and 3.0 % in prothrombin time ( P < 0.001 ) from baseline with sugammadex occurred 10 min after administration and resolved within 60 min .
RESULTS	There were no significant differences between sugammadex and usual care for other blood loss measures ( transfusion , 24-h drain volume , drop in hemoglobin , and anemia ) , or risk of venous thromboembolism , and no cases of anaphylaxis .
CONCLUSIONS	Sugammadex produced limited , transient ( < 1 h ) increases in activated partial thromboplastin time and prothrombin time but was not associated with increased risk of bleeding versus usual care .

###24409779
OBJECTIVE	To compare the therapeutic effect of traditional and modified apocrine gland removal surgery with the combination of high radiofrequency knife for axillary osmidrosis .
METHODS	105 cases ( 210 sides ) were randomly divided into traditional group A ( 38 cases , 76 sides ) and modified group B ( 67 cases , 134 sides ) .
METHODS	The wound healing and complications were recorded .
METHODS	The clinical effect was followed up for 6-12 months after operation .
RESULTS	No flap necrosis happened in both groups .
RESULTS	The cure rate was 82.89 % ( 63/76 ) ) and 92.54 % ( 124/134 ) in group A and B , respectively , which was significantly different ( P < 0.05 ) .
RESULTS	The effective rate of hair removal in group A and B was 42.1 % , 59.7 % ( P < 0.05 ) .
RESULTS	There is no markedly difference between the two groups in postoperative hematoma ( P > 0.05 ) .
RESULTS	The recurrence rate in group A and B was 9.21 % and 1.49 % respectively , with a statistically difference between them ( P < 0.05 ) .
CONCLUSIONS	Modified apocrine gland removal surgery with the combination of high radiofrequency knife can expose the apocrine gland better and the gland , as well as hair , can be removed in the most .
CONCLUSIONS	The residue hair and recurrency of osmidrosis are very lower .

###25741666
OBJECTIVE	Minimal information exists regarding the long-term comparative effectiveness of telemedicine to provide diabetic retinopathy screening examinations .
OBJECTIVE	To compare telemedicine to traditional eye examinations in their ability to provide diabetic retinopathy screening examinations .
METHODS	From August 1 , 2006 , through September 31 , 2009 , 567 participants with diabetes were randomized and followed up to 5 years of follow-up ( last date of patient follow-up occurred on August 6 , 2012 ) as part of a multicenter randomized clinical trial with an intent to treat analysis .
METHODS	We assigned participants to telemedicine with a nonmydriatic camera in a primary care medical clinic ( n = 296 ) or traditional surveillance with an eye care professional ( n = 271 ) .
METHODS	Two years after enrollment , we offered telemedicine to all participants .
METHODS	Percentage of participants receiving annual diabetic retinopathy screening examinations , percentage of eyes with worsening diabetic retinopathy during the follow-up period using a validated scale from stage 0 ( none ) to stage 4 ( proliferative diabetic retinopathy ) , and percentage of telemedicine participants who would require referral to an eye care professional for follow-up care using a cutoff of moderate diabetic retinopathy or worse , the presence of macular edema , or an unable-to-determine result for retinopathy or macular edema .
RESULTS	The telemedicine group was more likely to receive a diabetic retinopathy screening examination when compared with the traditional surveillance group during the 6-month or less ( 94.6 % [ 280/296 ] vs 43.9 % [ 119/271 ] ; 95 % CI , 46.6 % -54.8 % ; P < .001 ) and greater than 6-month through 18-month ( 53.0 % [ 157/296 ] vs 33.2 % [ 90/271 ] ; 95 % CI , 16.5 % -23.1 % ; P < .001 ) time bins .
RESULTS	After we offered telemedicine to both groups , we could not identify a difference between the groups in the percentage of diabetic retinopathy screening examinations .
RESULTS	Diabetic retinopathy worsened by 2 stages or more in 35 ( 8.6 % ) of 409 participants ( 95 % CI , 5.8 % -11.2 % ) and improved by 2 stages or more in 5 ( 1.2 % ) of 409 participants ( 95 % CI , 0.1 % -2.3 % ) during the 4-year period .
RESULTS	The percent of telemedicine participants requiring referral ranged from 19.2 % ( 52/271 ) to 27.9 % ( 58/208 ) .
CONCLUSIONS	Telemedicine increased the percentage of diabetic retinopathy screening examinations , most participants did not require referral to an eye care professional , and diabetic retinopathy levels were generally stable during the study period .
CONCLUSIONS	This finding suggests that primary care clinics can use telemedicine to screen for diabetic retinopathy and monitor for disease worsening over a long period .
BACKGROUND	clinicaltrials.gov Identifier : NCT01364129 .

###25371536
BACKGROUND	In this randomized trial , strut coverage and neointimal proliferation of a therapy of bare metal stents ( BMSs ) postdilated with the paclitaxel drug-eluting balloon ( DEB ) was compared with everolimus drug-eluting stents ( DESs ) at 6-month follow-up using optical coherence tomography .
BACKGROUND	We hypothesized sufficient stent coverage at follow-up .
RESULTS	A total of 105 lesions in 90 patients were treated with either XIENCE V DES ( n = 51 ) or BMS postdilated with the SeQuent Please DEB ( n = 54 ) .
RESULTS	At follow-up , comparable results on the primary optical coherence tomography end point ( percentage uncovered struts 5.649.65 % in BMS+DEB versus 4.939.29 % in DES ; P = 0.366 ) were found .
RESULTS	Thus , BMS+DEB achieved the prespecified noninferiority margin of 5 % uncovered struts versus DES ( difference between treatment means , 0.71 % ; one-sided upper 95 % confidence interval , 4.14 % ; noninferiority P = 0.04 ) .
RESULTS	Optical coherence tomography analysis showed significantly more global neointimal proliferation in the BMS+DEB group ( 15.77.8 versus 11.05.2 mm ( 3 ) proliferation volume/cm stent length ; P = 0.002 ) .
RESULTS	No significant focal in-stent stenosis analyzed with angiography ( percentage diameter stenosis at follow-up , 22.811.9 versus 16.910.4 ; P = 0.014 ) and optical coherence tomography ( peak local area stenosis , 39.513.8 % versus 36.815.6 % ; P = 0.409 ) was found .
CONCLUSIONS	Good stent strut coverage of > 94 % was found in both therapy groups .
CONCLUSIONS	Despite greater suppression of global neointimal growth in DES , both DES and BMS+DEB effectively prevented clinically relevant focal restenosis at 6-month follow-up .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01056744 .

###24804802
BACKGROUND	Few studies to date have used the cancer diagnosis as a teachable moment to promote healthy behavior changes in survivors of cancer and their family members .
BACKGROUND	Given the role of obesity in the primary and tertiary prevention of breast cancer , the authors explored the feasibility of a mother-daughter weight loss intervention .
METHODS	A randomized controlled trial of a mailed weight loss intervention was undertaken among 68 mother-daughter dyads ( n = 136 ) , each comprised of a survivor of breast cancer ( AJCC stage 0-III ) and her adult biological daughter .
METHODS	All women had body mass indices 25 kg/m ( 2 ) and underwent in-person assessments at baseline , 6 months , and 12 months , with accelerometry and exercise capacity performed on a subset of individuals .
METHODS	All women received a personalized workbook and 6 newsletters over a 1-year period that promoted weight loss ; exercise ; and a nutrient-rich , low-energy density diet .
METHODS	A total of 25 dyads received individually tailored instruction ( individual ) , 25 dyads received team-tailored instruction ( TEAM ) , and 18 dyads received standardized brochures ( control ) .
RESULTS	The trial met its accrual target , experienced 90 % retention , and caused no serious adverse events .
RESULTS	Significant differences in baseline to 12-month changes were observed between individual versus control mothers for body mass index , weight , and waist circumference ( WC ) ; significant differences also were observed in the WC of corresponding daughters ( P < .05 ) .
RESULTS	Significant differences were found between individual versus control and team versus control dyads for WC ( P = .0002 and .018 , respectively ) , minutes per week of physical activity ( P = .031 and .036 , respectively ) , and exercise capacity ( P = .047 for both ) .
CONCLUSIONS	Significant improvements in lifestyle behaviors and health outcomes are possible with tailored print interventions directed toward survivors of cancer and their family members .
CONCLUSIONS	For greater impact , more research is needed to expand this work beyond the mother-daughter dyad .

###25886009
BACKGROUND	Childhood obesity is an increasing health problem globally .
BACKGROUND	Overweight and obesity may be established as early as 2-5 years of age , highlighting the need for evidence-based effective prevention and treatment programs early in life .
BACKGROUND	In adults , mobile phone based interventions for weight management ( mHealth ) have demonstrated positive effects on body mass , however , their use in child populations has yet to be examined .
BACKGROUND	The aim of this paper is to report the study design and methodology of the MINSTOP ( Mobile-based Intervention Intended to Stop Obesity in Preschoolers ) trial .
METHODS	A two-arm , parallel design randomized controlled trial in 300 healthy Swedish 4-year-olds is conducted .
METHODS	After baseline measures , parents are allocated to either an intervention - or control group .
METHODS	The 6 - month mHealth intervention consists of a web-based application ( the MINSTOP app ) to help parents promote healthy eating and physical activity in children .
METHODS	MINISTOP is based on the Social Cognitive Theory and involves the delivery of a comprehensive , personalized program of information and text messages based on existing guidelines for a healthy diet and active lifestyle in pre-school children .
METHODS	Parents also register physical activity and intakes of candy , soft drinks , vegetables as well as fruits of their child and receive feedback through the application .
METHODS	Primary outcomes include body fatness and energy intake , while secondary outcomes are time spent in sedentary , moderate , and vigorous physical activity , physical fitness and intakes of fruits and vegetables , snacks , soft drinks and candy .
METHODS	Food and energy intake ( Tool for Energy balance in Children , TECH ) , body fatness ( pediatric option for BodPod ) , physical activity ( Actigraph wGT3x-BT ) and physical fitness ( the PREFIT battery of five fitness tests ) are measured at baseline , after the intervention ( six months after baseline ) and at follow-up ( 12 months after baseline ) .
CONCLUSIONS	This novel study will evaluate the effectiveness of a mHealth program for mitigating gain in body fatness among 4-year-old children .
CONCLUSIONS	If the intervention proves effective it has great potential to be implemented in child-health care to counteract childhood overweight and obesity .
BACKGROUND	ClinicalTrials.gov NCT02021786 ; 20 Dec 2013 .

###24427348
OBJECTIVE	Sevoflurane and propofol are both widely used in clinical anesthesia .
OBJECTIVE	The aim of this study is to compare the effects of sevoflurane and propofol on right ventricular function and pulmonary circulation in patients receiving esophagectomy .
METHODS	Forty adult patients undergoing an elective open-chest thoracotomy for esophagectomy were randomized to receive either propofol ( n = 20 ) or sevoflurane ( n = 20 ) as the main anesthetic agent .
METHODS	The study was performed in Changzheng Hospital .
METHODS	Hemodynamic data were recorded at specific intervals : before the surgery ( T0 ) , BIS values reaching 40 after anesthesia induction ( T1 ) , two-lung ventilation ( T2 ) , ten minutes after one-lung ventilation ( T3 ) , the end of the operation ( T4 ) using PiCCO2 and Swan-Ganz catheter .
RESULTS	CI , RVEF , RVSWI and RVEDVI were significantly smaller in propofol group than those in sevoflurane group throughout the surgery ( P < 0.05 ) .
RESULTS	However , SVRI was significantly greater in propofol group than that in sevoflurane group ( P < 0.05 ) .
RESULTS	Compared with the patients in propofol group , the patients who received sevoflurane had a greater reduction in OI and increase in Os/Ot ( P < 0.05 ) .
RESULTS	And , PVRI was significantly smaller in sevoflurane group than in propofol group ( P < 0.05 ) .
CONCLUSIONS	Anesthesia with sevoflurane preserved better right ventricular function than propofol in patients receiving esophagectomy .
CONCLUSIONS	However , propofol improved oxygenation and shunt fraction during one-lung ventilation compared with sevoflurane anesthesia .
CONCLUSIONS	To have the best effect , anesthesiologists can choose the two anesthetics flexibly according to the monitoring results .

###24930587
BACKGROUND	Chlorophyll-a is a novel photosensitizer recently tested for the treatment of acne vulgaris .
OBJECTIVE	We sought to evaluate the clinical efficacy and safety of chlorophyll-a photodynamic therapy used for acne treatment .
METHODS	Subjects with acne on both sides of the face were included .
METHODS	Eight treatment sessions were performed over a 4-week duration .
METHODS	Half of the face was irradiated using a blue and red light-emitting diode after topical application of chlorophyll-lipoid complex .
METHODS	The other half underwent only light-emitting diode phototherapy .
METHODS	The lesion counts and acne severity were assessed by a blinded examiner .
METHODS	Sebum secretion , safety , and histologic changes were also evaluated .
RESULTS	In total , 24 subjects completed the study .
RESULTS	Facial acne improved on both treated sides .
RESULTS	On the chlorophyll-a photodynamic therapy-treated side , there were significant reductions in acne lesion counts , acne severity grades , and sebum levels compared with the side treated with light-emitting diode phototherapy alone .
RESULTS	The side effects were tolerable in all the cases .
CONCLUSIONS	All the subjects were of Asian descent with darker skin types , which may limit the generalizability of the study .
CONCLUSIONS	A chlorophyll-a arm alone is absent , as is a no-treatment arm .
CONCLUSIONS	We suggest that chlorophyll-a photodynamic therapy for the treatment of acne vulgaris can be effective and safe with minimal side effects .

###25223172
OBJECTIVE	To observe the effect of Kuntai Capsule ( KC ) on the number of retrieved oocytes , the quality of high-quality oocytes and embryos in in vitro fertilization of poor ovarian response ( POR ) patients .
METHODS	Totally 70 POR patients preparing for in vitro fertilization-embryo transfer ( IVF-ET ) were randomly assigned to the observation group and the control group , 35 cases in each group .
METHODS	KC was administered to patients in the observation group in the preparation cycle ( i.e. , three menstrual cycles before IVF-ET ) and during the superovulation process .
METHODS	Those in the control group took placebo during this period .
METHODS	Before and after medication the improvement of Shen yin deficiency syndrome ( SYDS ) was observed in the two groups .
METHODS	The basal follicle-stimulating hormone ( bFSH ) , luteinizing hormone ( LH ) , estradiol ( E2 ) , anti-Mullerian hormone ( AMH ) , the ratio of FSH to LH , and antral follicle count ( AFC ) were observed .
METHODS	Besides , the E2 level of a single ovum on the day of HCG injection , the number of retrieved oocytes , the high-quality oocyte rate , and the high-quality embryos were observed .
RESULTS	Compared with the control group , the SYDS , decreased bFSH and LH levels , increased ACF numbers , the E2 level of a single ovum on the day of HCG injection , the number of retrieved oocytes , high-quality oocytes , and high-quality embryos were superior in the observation group ( P < 0.05 ) .
RESULTS	There was no statistical difference in the decreased FSH/LH level ( P > 0.05 ) .
RESULTS	E2 and AMH increased after medication of KC in the observation group , while they decreased after administration of placebos in the control group .
RESULTS	There was statistical difference in the post-pre treatment difference of E2 and AMH between the two groups ( P < 0.05 ) .
CONCLUSIONS	KC could increase the number of retrieved oocytes , and elevate the quality of occytes and embryos in the IVF-ET .

###25534151
BACKGROUND	Post-visit `` booster '' sessions have been recommended to augment the impact of brief interventions delivered in the emergency department ( ED ) .
BACKGROUND	This paper , which focuses on implementation issues , presents descriptive information and interventionists ' qualitative perspectives on providing brief interventions over the phone , challenges , `` lessons learned '' , and recommendations for others attempting to implement adjunctive booster calls .
METHODS	Attempts were made to complete two 20-minute telephone `` booster '' calls within a week following a patient 's ED discharge with 425 patients who screened positive for and had recent problematic substance use other than alcohol or nicotine .
RESULTS	Over half ( 56.2 % ) of participants completed the initial call ; 66.9 % of those who received the initial call also completed the second call .
RESULTS	Median number of attempts to successfully contact participants for the first and second calls were 4 and 3 , respectively .
RESULTS	Each completed call lasted an average of about 22 minutes .
RESULTS	Common challenges/barriers identified by booster callers included unstable housing , limited phone access , unavailability due to additional treatment , lack of compensation for booster calls , and booster calls coming from an area code different than the participants ' locale and from someone other than ED staff .
CONCLUSIONS	Specific recommendations are presented with respect to implementing a successful centralized adjunctive booster call system .
CONCLUSIONS	Future use of booster calls might be informed by research on contingency management ( e.g. , incentivizing call completions ) , smoking cessation quitlines , and phone-based continuing care for substance abuse patients .
CONCLUSIONS	Future research needs to evaluate the incremental benefit of adjunctive booster calls on outcomes over and above that of brief motivational interventions delivered in the ED setting .

###24439986
BACKGROUND	There are conflicting data on the use of cilostazol as triple antiplatelet therapy ( TAPT ) for improving clinical outcomes after drug-eluting stent implantation .
BACKGROUND	We aimed to evaluate whether 3-month use of cilostazol in addition to dual antiplatelet therapy ( DAPT ) improved clinical outcomes in patients with long or multivessel coronary artery disease ( CAD ) after biolimus-eluting stent ( BES ) implantation .
METHODS	Patients ( n = 630 ) who had been successfully treated with BES implantation for lesions with 28 mm in stent length or 2 stents for different coronary arteries were enrolled in this prospective randomized multicenter trial .
METHODS	All patients were randomly assigned to receive either DAPT ( aspirin and clopidogrel for 12 months , n = 314 ) or TAPT ( DAPT plus 3-month cilostazol use , n = 316 ) .
METHODS	The primary end point was a device-oriented composite consisting of cardiac death , myocardial infarction ( not clearly attributable to a nontarget vessel ) , and ischemia-driven target lesion revascularization at 1-year follow-up .
RESULTS	A total of 314 patients in DAPT and 308 patients in TAPT were analyzed .
RESULTS	Multivessel CAD was present in 65.7 % of patients .
RESULTS	Stents 28 mm in length were implanted in 58.1 % of lesions .
RESULTS	There were no significant differences in baseline and angiographic characteristics between the 2 groups .
RESULTS	The primary end point was similar between the 2 groups ( 2.3 % in DAPT vs 1.9 % in TAPT , log-rank P = .799 ) .
CONCLUSIONS	In patients treated with BES implantation for long or multivessel CAD , 3 months of cilostazol use in addition to DAPT did not improve clinical outcome at 1-year follow-up .

###24642191
BACKGROUND	The major side-effect of photodynamic therapy ( PDT ) on port wine stains ( PWS ) is pain during the treatment .
BACKGROUND	Although several strategies for controlling the pain during topical PDT achieve a reduction in the levels of pain , none were completely effective and convenient .
BACKGROUND	This randomized , double-blind , placebo-controlled clinical trial was designed to evaluate the efficacy and safety of an oral analgesic for the treatment of pain in PDT on PWS .
METHODS	Fifty-eight patients with PWS on the face were included .
METHODS	The treatment and placebo groups were selected by computer randomization .
METHODS	The patients , doctor and statistician were blinded to the patients ' groups .
METHODS	The analgesic contained 5mg of oxycodone in combination with 325 mg of acetaminophen .
METHODS	The patient took the tablet orally 30 min before PDT .
METHODS	The patient was injected intravenously with 4-5mg / kg photosensitizer PSD-007 within 5 min , and then the lesion was exposed to a 532 nm laser immediately for 30-60 min at 100 mW/cm ( 2 ) .
METHODS	The intensity of the pain during irradiation , the characteristic and beginning time of pain , and adverse effects were recorded .
METHODS	A visual analog scale ( VAS ) was used to assess the pain .
CONCLUSIONS	The time of the pain beginning was 8.31 4.58 min in the treatment group and 7.10 3.54 min in the placebo group , which was not significantly different ( P = 0.266 ) .
CONCLUSIONS	The VAS score in the treatment group was 7.88 1.52 compared with 8.17 1.12 in the placebo group , with no significant difference ( P = 0.422 ) .
CONCLUSIONS	The subgroup of age , gender , lesion location and classification between two groups had similar VAS score ( P > 0.05 ) .
CONCLUSIONS	No serious adverse events were reported .
CONCLUSIONS	This study found that oral oxycodone 5mg/acetaminophen 325 mg was completely ineffective for pain relief , and age , gender , lesion location and classification did not influence the pain perception and the analgesic effect .
CONCLUSIONS	The challenge of controlling pain during PDT on PWS remains .

###25622149
BACKGROUND	New regimens to shorten tuberculosis treatment and manage patients with drug-resistant tuberculosis who are infected with HIV are urgently needed .
BACKGROUND	Experimental and clinical evidence suggests that the new drugs bedaquiline ( B ) and pretomanid ( Pa ) , combined with an existing drug , pyrazinamide ( Z ) , and a repurposed drug , clofazimine ( C ) , may assist treatment shortening of drug-susceptible and drug-resistant tuberculosis .
OBJECTIVE	To evaluate the 14-day bactericidal activity of C and Z in monotherapy and in combinations with Pa and B.
METHODS	Groups of 15 treatment-naive , sputum smear-positive patients with pulmonary tuberculosis were randomized to receive combinations of B with Z-C , Pa-Z , Pa-Z-C , and Pa-C , or C or Z alone , or standard combination treatment for 14 days .
METHODS	The primary endpoint was the mean daily fall in log10 Mycobacterium tuberculosis CFU per milliliter sputum estimated by joint nonlinear mixed-effects Bayesian regression modeling .
RESULTS	Estimated activities were 0.167 ( 95 % confidence interval [ CI ] , 0.075-0 .257 ) for B-Pa-Z , 0.151 ( 95 % CI , 0.071-0 .232 ) for standard treatment , 0.124 ( 95 % CI , 0.035-0 .214 ) for B-Z-C , 0.115 ( 95 % CI , 0.039-0 .189 ) for B-Pa-Z-C , and 0.076 ( 95 % CI , 0.005-0 .145 ) for B-Pa-C .
RESULTS	Z alone had modest activity ( 0.036 ; 95 % CI , -0.026 to 0.099 ) .
RESULTS	C had no activity alone ( -0.017 ; 95 % CI , -0.085 to 0.053 ) or in combinations .
RESULTS	Treatments were well tolerated and safe .
CONCLUSIONS	B-Pa-Z , including two novel agents without resistance in prevalent M. tuberculosis strains , is a potential new tuberculosis treatment regimen .
CONCLUSIONS	C had no measurable activity in the first 14 days of treatment .
CONCLUSIONS	Clinical trial registered with www.clinicaltrials.gov ( NCT 01691534 ) .

###24643486
OBJECTIVE	To evaluate the impact of an 18-month school obesity prevention intervention on the health behaviors of 4th and 5th grade students based on ecological principles and formative research conducted in Mexico .
METHODS	A Randomized Control Trial ( RCT ) , design was used to assign 27 schools to one of three conditions : basic or plus interventions and control .
METHODS	School environment measures , children 's eating and physical activity behaviors , and body mass index were assessed four times over a 2-year period in a sample of 830 students .
RESULTS	In the intervention schools , the availability of healthy foods increased with a concomitant decrease in unhealthy food availability .
RESULTS	Food intake showed the same trend .
RESULTS	In the intervention schools , children did not engage in more moderate to vigorous physical activity ( MVPA ) in physical education ( PE ) class or recess but increased steps taken .
RESULTS	Obesity prevalence did not change .
CONCLUSIONS	The intervention improved the school food environment and child healthy behaviors .

###25069201
OBJECTIVE	To evaluate the therapeutic effect of warm acupuncture ( moxa-heated acupuncture ) needle stimulation of Waiguan ( TE 5 ) acupoint in the treatment of shoulder-hand syndrome ( phase I ) in patients with stroke .
METHODS	Sixty stroke patients with shoulder-hand syndrome ( phase I ) were equally randomized into control group and warm acupuncture group .
METHODS	Patients of the warm acupuncture group were treated by warm acupuncture stimulation of the affected TE 5 in combination with routine acupuncture stimulation of Jianyu ( LI 15 ) , Jianjing ( GB 21 ) , Quchi ( LI 11 ) , Wangu ( SI 4 ) , Yangchi ( TE 4 ) and Hegu ( LI 4 ) , and rehabilitation training ( passive and active upper-limb motion exercise for 30 min , once daily ) , and patients of the control group treated with routine acupuncture stimulation of the same acupoints mentioned above , and rehabilitation training .
METHODS	The treatment was conducted once daily , 5 times per week for two weeks .
METHODS	The patients ' clinical conditions were evaluated by using Visual Analogue Scale ( VAS , 0-10 points , shoulder pain degree ) , edema severity score ( 0 point : normal , 2 points : mild , 4 points : moderate , and 6 points : severe ) and simplified Fugl-Meyer motor assessment scale ( 0 , 1 and 2 points , upper-limb motor function ) before and after the treatment .
RESULTS	After the treatment , the scores of VAS and edema severity of the two groups were significantly decreased in comparison with pre-treatment in the same one group ( P < 0.01 ) , and the Fugl-Meyer motor scores were considerably increased ( P < 0.01 ) , suggesting an improvement of the shoulder-hand syndrome after two weeks ' treatment .
RESULTS	Of the two 30 patients in the control group and warm acupuncture group , 0 and 2 ( 6.7 % ) were cured , 7 ( 23.3 % ) and 25 ( 83.3 % ) experienced marked improvement , 17 ( 56.7 % ) and 2 ( 6.7 % ) were effective , 6 ( 20.0 % ) and 1 ( 3.3 % ) invalid , with the effective rates being 80.0 % and 96.7 % , respectively .
RESULTS	The effect of warm acupuncture group was superior to that of the control group ( P < 0.05 ) .
CONCLUSIONS	Warm acupuncture combined with routine acupuncture and rehabilitation training is effective in improving shoulder pain , hand edema and limb motor function in stroke patients with shoulder-hand syndrome at phase I.

###25247995
BACKGROUND	Intermittent preventive treatment in pregnancy ( IPTp ) with sulfadoxine-pyrimethamine ( SP ) is recommended for malaria prevention in HIV-negative pregnant women , but it is contraindicated in HIV-infected women taking daily cotrimoxazole prophylaxis ( CTXp ) because of potential added risk of adverse effects associated with taking two antifolate drugs simultaneously .
BACKGROUND	We studied the safety and efficacy of mefloquine ( MQ ) in women receiving CTXp and long-lasting insecticide treated nets ( LLITNs ) .
RESULTS	A total of 1,071 HIV-infected women from Kenya , Mozambique , and Tanzania were randomized to receive either three doses of IPTp-MQ ( 15 mg/kg ) or placebo given at least one month apart ; all received CTXp and a LLITN .
RESULTS	IPTp-MQ was associated with reduced rates of maternal parasitemia ( risk ratio [ RR ] , 0.47 [ 95 % CI 0.27-0 .82 ] ; p = 0.008 ) , placental malaria ( RR , 0.52 [ 95 % CI 0.29-0 .90 ] ; p = 0.021 ) , and reduced incidence of non-obstetric hospital admissions ( RR , 0.59 [ 95 % CI 0.37-0 .95 ] ; p = 0.031 ) in the intention to treat ( ITT ) analysis .
RESULTS	There were no differences in the prevalence of adverse pregnancy outcomes between groups .
RESULTS	Drug tolerability was poorer in the MQ group compared to the control group ( 29.6 % referred dizziness and 23.9 % vomiting after the first IPTp-MQ administration ) .
RESULTS	HIV viral load at delivery was higher in the MQ group compared to the control group ( p = 0.048 ) in the ATP analysis .
RESULTS	The frequency of perinatal mother to child transmission of HIV was increased in women who received MQ ( RR , 1.95 [ 95 % CI 1.14-3 .33 ] ; p = 0.015 ) .
RESULTS	The main limitation of the latter finding relates to the exploratory nature of this part of the analysis .
CONCLUSIONS	An effective antimalarial added to CTXp and LLITNs in HIV-infected pregnant women can improve malaria prevention , as well as maternal health through reduction in hospital admissions .
CONCLUSIONS	However , MQ was not well tolerated , limiting its potential for IPTp and indicating the need to find alternatives with better tolerability to reduce malaria in this particularly vulnerable group .
CONCLUSIONS	MQ was associated with an increased risk of mother to child transmission of HIV , which warrants a better understanding of the pharmacological interactions between antimalarials and antiretroviral drugs .
BACKGROUND	ClinicalTrials.gov NCT 00811421 ; Pan African Clinical Trials Registry PACTR 2010020001813440 Please see later in the article for the Editors ' Summary .

###25022109
OBJECTIVE	To compare the efficacy difference in the treatment of functional dyspepsia between acupuncture at the acupoints selected by pattern/syndrome differentiation and domperidone .
METHODS	Seventy cases were randomized into an acupuncture group ( 35 cases ) and a western medication group ( 35 cases ) .
METHODS	In the acupuncture group , Zusanli ( ST 36 ) and Neiguan ( PC 6 ) were selected .
METHODS	Taichong ( LR 3 ) and Neiting ( ST 44 ) were added for excess syndrome while Gongsun ( SP 4 ) and Yinlingquan ( SP 9 ) were added for deficiency syndrome .
METHODS	A pair of electrodes was attached to one acupoint and an assistant point ( 2 mm next to the acupoint centripetally ) and stimulated with disperse-dense wave at 2 Hz/100 Hz , once a day .
METHODS	In the western medication group , domperidone was prescribed for oral administration , 10 mg each time , three times a day .
METHODS	In the two groups , the treatment of 5 days made one session and 4 sessions were required totally .
METHODS	Nepean dyspepsia index ( NDI ) was compared after treatment , 1 , 2 , 3 , 4 and 5 months after treatment between the two groups respectively .
RESULTS	The score of symptom and score of life quality in NDI after treatment and at each follow-up time point were improved obviously in the acupuncture group as compared with those before treatment ( all P < 0.01 ) .
RESULTS	In the western mediation group , the score of symptom and the score of life quality in NDI after treatment and in follow-up of 1 , 2 and 3 months were improved obviously as compared with those before treatment ( all P < 0.01 ) , but the differences were not significant in follow-up of 4 and 5 months ( both P > 0.05 ) .
RESULTS	Compared with the western medication group , the symptom score of NDI was reduced obviously after treatment and in each time point of follow-up in the acupuncture group ( P < 0.05 , P < 0.01 ) , and the score of life quality was increased obviously ( P < 0.05 , P < 0.01 ) .
CONCLUSIONS	Acupuncture at the acupoints selected by pattern/syndrome differentiation and domperidone are effective in the treatment of functional dyspepsia .
CONCLUSIONS	Domperidone is unsatisfactory in the long-term effect , but acupuncture achieves the positive short-term and long-term effects on functional dyspepsia .

###25340832
OBJECTIVE	We compared the efficacy and safety of ozenoxacin ( a new nonfluorinated quinolone ) 1 % cream with placebo in the treatment of impetigo .
METHODS	In a randomized , double-blind , multicenter study , patients received ozenoxacin cream or placebo cream twice daily for 5 days ( a third group received retapamulin 1 % ointment as a control ) .
METHODS	Clinical , microbiological and laboratory evaluations were performed during follow-up ( over 2 weeks ) .
RESULTS	Ozenoxacin was superior to placebo ( success rate 34.8 vs 19.2 % ; p = 0.003 ) .
RESULTS	Microbiological success was 70.8 % for ozenoxacin and 38.2 % for placebo after 3-4 days and 79.2 % versus 56.6 % after 6-7 days .
RESULTS	Ozenoxacin produced more rapid microbiological clearance than retapamulin .
RESULTS	All treatments were well tolerated .
CONCLUSIONS	Ozenoxacin 1 % cream was effective and safe in the treatment of impetigo .

###25536639
OBJECTIVE	Anemia is the most common adverse event in patients with chronic hepatitis C virus ( HCV ) treated with telaprevir ( TVR ) combined triple therapy .
OBJECTIVE	We examined the effects of drug dose adjustment on anemia and a sustained viral response ( SVR ) during combination therapy .
METHODS	This study enrolled 62 patients treated with TVR ( 2,250 mg ) for 12 weeks plus pegylated interferon-alpha-2b and ribavirin for 24 weeks .
METHODS	The patients were assigned randomly to the TVR-standard or - reduced groups before treatment .
METHODS	At the occurrence of anemia ( hemoglobin < 12 g/dL ) , the TVR-reduced group received 1500 mg TVR plus the standard dose of ribavirin , whereas the TVR-standard group received the standard TVR dose ( 2,250 mg ) and a reduced dose of ribavirin ( 200 mg lower than prescribed originally ) .
METHODS	The safety and SVR at 24 weeks were compared between the TVR-standard ( n = 28 ) and TVR-reduced ( n = 25 ) groups .
RESULTS	No differences in the proportion of patients who became HCV RNA-negative were detected between the TVR-standard and - reduced groups ( 72 and 72 % at week 4 , 79 and 84 % at the end of treatment , and 76 and 80 % at SVR24 , respectively ) .
RESULTS	Two groups had comparable numbers of adverse events , which led to the discontinuation of TVR in 14 patients of TVR-standard group and in 14 of TVR-reduced group .
RESULTS	A lower incidence of renal impairment was observed in the TVR-reduced group ( 6 % ) than the TVR-standard group ( 11 % , not statistically significant ) .
CONCLUSIONS	TVR dose adjustment could prevent anemia progression without weakening the anti-viral effect during triple therapy in HCV-patients .

###25257450
OBJECTIVE	To compare the temporomandibular joint changes in adolescent Class II division 1 malocclusion patients with mandibular retrusion treated with Twin - block and Class II elastics .
METHODS	Sixty Class II division 1 malocclusion patients with mandibular retrusion were divided into 3 groups ( Twin - block group , Class II elastic group and control group , 20 patients in each group ) randomly .
METHODS	Differences of condylar process morphology were compared using cone - beam CT ( CBCT ) before and after treatment .
RESULTS	Condylar largest anteroposterior diameter and upper condylar height increased after treatment in both Twin-block group and Class II elastic group .
RESULTS	The condylar largest anteroposterior diameter and upper condylar height were longer in both Twin - block group [ ( 8.51 1.48 ) and ( 7.39 1.42 ) mm ] and Class II elastic group [ ( 8.44 1.03 ) and ( 7.24 0.89 ) mm ] than those in the control group [ ( 7.47 1.27 ) and ( 6.47 1.56 ) mm ] ( P < 0.05 ) .
RESULTS	No significant difference was found in other measurements ( P > 0.05 ) .
CONCLUSIONS	Condylar largest anteroposterior diameter and upper condylar height in Class II division 1 malocclusion patients increased after treatment using Twin - block and Class II elastics .
CONCLUSIONS	There was no significant difference between two groups .

###24305788
OBJECTIVE	During total knee arthroplasty ( TKA ) blood loss can be significant and in spite of all techniques for reducing blood loss there is still a significant possibility for blood transfusions .
OBJECTIVE	For blood loss management during TKA , pre-operative autologous blood donation ( PABD ) is still a standard of care .
OBJECTIVE	In this prospective randomised study we have evaluated the efficacy of PABD in patients undergoing TKA to answer the question whether there is any need for autologous blood donations during TKA and , if yes , for which group of patients .
METHODS	Patients were randomised to three groups .
METHODS	In group 1 patients did not donate autologous blood , in group 2 patients donated 1 dose 72hours prior to TKA and in group 3 patients donated autologous blood 14days prior to TKA .
METHODS	In all patients haemoglobin , haematocrit , thrombocyte and reticulocyte values , iron concentrations ( Fe , unsaturated iron binding capacity , total iron binding capacity ) , activated partial thromboplastin time , prothrombin time , and intra-operative and post-operative blood loss were measured and compared .
RESULTS	With PABD there was no reduction in allogeneic blood transfusions and a large number of taken doses of autologous blood was discarded , which significantly increased the cost of treatment for these patients .
RESULTS	For patients undergoing TKA , PABD can provoke iatrogenic anaemia and thereby increase the likelihood of the need for allogeneic blood transfusion .
CONCLUSIONS	Results of our study showed that PABD in non-anaemic patients is not justified and is not economically feasible .

###25029917
METHODS	Randomized clinical trial .
METHODS	Objectives To compare the blood pressure ( BP ) and heart rate ( HR ) response of healthy volunteers to posteriorly directed ( anterior-to-posterior [ AP ] ) pressure applied to the cervical spine versus placebo .
BACKGROUND	Manual therapists employ cervical spine AP mobilizations for various cervical-shoulder pain conditions .
BACKGROUND	However , there is a paucity of literature describing the procedure , cardiovascular response , and safety profile .
METHODS	Thirty-nine ( 25 female ) healthy participants ( mean SD age , 24.7 1.9 years ) were randomly assigned to 1 of 2 groups .
METHODS	Group 1 received a placebo , consisting of light touch applied to the right C6 costal process .
METHODS	Group 2 received AP pressure at the same location .
METHODS	Blood pressure and HR were measured prior to , during , and after the application of AP pressure .
METHODS	One-way analysis of variance and paired-difference statistics were used for data analysis .
RESULTS	There was no statistically significant difference between groups for mean systolic BP , mean diastolic BP , and mean HR ( P > .05 ) for all time points .
RESULTS	Within-group comparisons indicated statistically significant differences between baseline and post-AP pressure HR ( -2.8 bpm ; 95 % confidence interval : -4.6 , -1.1 ) and between baseline and post-AP pressure systolic BP ( -2.4 mmHg ; 95 % confidence interval : -3.7 , -1.0 ) in the AP group , and between baseline and postplacebo systolic BP ( -2.6 mmHg ; 95 % confidence interval : -4.2 , -1.0 ) in the placebo group .
RESULTS	No participants reported any adverse reactions or side effects within 24 hours of testing .
CONCLUSIONS	AP pressure caused a statistically significant physiologic response that resulted in a minor drop in HR ( without causing asystole or vasodepression ) after the procedure , whereas this cardiovascular change did not occur for those in the placebo group .
CONCLUSIONS	Within both groups , there was a small but statistically significant reduction in systolic BP following the procedure .

###24658389
OBJECTIVE	To examine whether improvements in health behaviors are associated with reduced risk of cardiovascular disease ( CVD ) in individuals with newly diagnosed type 2 diabetes .
METHODS	Population-based prospective cohort study of 867 newly diagnosed diabetic patients aged between 40 and 69 years from the treatment phase of the ADDITION-Cambridge study .
METHODS	Because the results for all analyses were similar by trial arm , data were pooled , and results were presented for the whole cohort .
METHODS	Participants were identified via population-based stepwise screening between 2002 and 2006 , and underwent assessment of physical activity ( European Prospective Investigation into Cancer-Norfolk Physical Activity Questionnaire ) , diet ( plasma vitamin C and self-report ) , and alcohol consumption ( self-report ) at baseline and 1 year .
METHODS	A composite primary CVD outcome was examined , comprised of cardiovascular mortality , nonfatal myocardial infarction , nonfatal stroke , and revascularization .
RESULTS	After a median ( interquartile range ) follow-up period of 5.0 years ( 1.3 years ) , 6 % of the cohort experienced a CVD event ( 12.2 per 1,000 person-years ; 95 % CI 9.3-15 .9 ) .
RESULTS	CVD risk was inversely related to the number of positive health behaviors changed in the year after diabetes diagnosis .
RESULTS	The relative risk for primary CVD event in individuals who did not change any health behavior compared with those who adopted three/four healthy behaviors was 4.17 ( 95 % CI 1.02-17 .09 ) , adjusting for age , sex , study group , social class , occupation , and prescription of cardioprotective medication ( P for trend = 0.005 ) .
CONCLUSIONS	CVD risk was inversely associated with the number of healthy behavior changes adopted in the year after the diagnosis of diabetes .
CONCLUSIONS	Interventions that promote early achievement of these goals in patients with newly diagnosed diabetes could help reduce the burden of diabetes-related morbidity and mortality .

###24520906
OBJECTIVE	Several studies have found that brief interventions ( BIs ) for drug misuse have superior effectiveness to no-treatment controls .
OBJECTIVE	However , many health centers do not provide BIs for drug use consistently due to insufficient behavioral health staff capacity .
OBJECTIVE	Computerized BIs for drug use are a promising approach , but their effectiveness compared with in-person BIs has not been established .
OBJECTIVE	This study compared the effectiveness of a computerized brief intervention ( CBI ) to an in-person brief intervention ( IBI ) delivered by a behavioral health counselor .
METHODS	Two-arm randomized clinical trial , conducted in two health centers in New Mexico , United States .
METHODS	Participants were 360 adult primary care patients with moderate-risk drug scores on the Alcohol , Smoking , and Substance Involvement Screening Test ( ASSIST ) who were randomly assigned on a 1:1 basis to a computerized brief intervention ( CBI ) or to an in-person brief intervention ( IBI ) delivered by a behavioral health counselor .
METHODS	Assessments were conducted at baseline and 3-month follow-up , and included the ASSIST and drug testing on hair samples .
RESULTS	The IBI and CBI conditions did not differ at 3 months on global ASSIST drug scores [ b = -1.79 ; 95 % confidence interval ( CI ) = -4.37 , 0.80 ] or drug-positive hair tests [ odds ratio ( OR ) = 0.97 ; 95 % CI = 0.47 , 2.02 ] .
RESULTS	There was a statistically significant advantage of CBI over IBI in substance-specific ASSIST scores for marijuana ( b = -1.73 ; 95 % CI = -2.91 , -0.55 ; Cohen 's d = 0.26 ; P = 0.004 ) and cocaine ( b = -4.48 ; 95 % CI = -8.26 , -0.71 ; Cohen 's d = 0.50 ; P = 0.021 ) at 3 months .
CONCLUSIONS	Computerized brief intervention can be an effective alternative to in-person brief intervention for addressing moderate drug use in primary care .

###25402578
OBJECTIVE	To examine the relationship between inflammatory and coagulation biomarkers and cardiac autonomic function ( CAF ) as measured by heart rate variability in persons with HIV .
METHODS	This analysis included 4073 HIV-infected persons from the Strategies for Management of Antiretroviral Therapy study .
METHODS	We examined the association between IL-6 , high-sensitivity C-reactive protein ( hsCRP ) and D-dimer with heart rate variability measures ( SDNN and rMSSD ) , both cross-sectionally and longitudinally .
RESULTS	Cross-sectional analysis revealed significant inverse associations between IL-6 , hsCRP and d-dimer with SDNN and rMSSD ( p < 0.01 for all comparisons ) .
RESULTS	However , longitudinal analysis failed to show a significant association between baseline IL-6 , hsCRP and d-dimer with change in CAF over time .
CONCLUSIONS	Cross-sectionally , higher levels of inflammatory and coagulation biomarkers were associated with lower levels of CAF in the Strategies for Management of Antiretroviral Therapy trial .
CONCLUSIONS	Although deterioration in CAF was observed during followup , baseline levels of inflammatory and coagulation markers were not predictive of the decline in CAF over time .

###25112096
OBJECTIVE	To compare the difference in the efficacy on low back pain of cold-damp pattern between electric-thermal Bian-stone therapy and moxibustion box therapy .
METHODS	Forty-one cases of low back pain of cold-damp pattern were randomized into an electric-thermal Bian-stone therapy group ( group A , 26 cases ) and a box moxibustion therapy group ( group B , 15 cases ) .
METHODS	In the group A , the electric-thermal Bian-stone was placed over Shenshu ( BL 23 ) and Weizhong ( BL 40 ) .
METHODS	The temperature of stone was adjusted in accordance with patient 's comfort .
METHODS	In the group B , moxibustion box was used over Shenshu ( BL 23 ) and Weizhong ( BL 40 ) .
METHODS	The treatment was given once every day or every two days .
METHODS	Ten treatments made one session .
METHODS	The symptom and physical signs score of low back pain and the score of cold-damp syndrome were observed before and after treatment in the patients .
RESULTS	The symptom and physical signs score of low back pain and the score of cold-damp syndrome were all improved in the two groups ( all P < 0.01 ) .
RESULTS	The changing rate of symptom and physical signs and syndrome were ( 37.04 + / - 32.68 ) % and ( 22.85 + / - 29.95 ) % in the group A , and were ( 47.29 + / - 22.08 ) % and ( 23.89 + / - 22.53 ) % in the group B , respectively , without significant difference in comparison between the two groups ( all P > 0.05 ) .
CONCLUSIONS	The efficacy on low back pain of cold-damp pattern treated with the electric-thermal Bian-stone therapy is similar to that of moxibustion box therapy .
CONCLUSIONS	This therapy is characterized as more convenient , safer operation and less pollution .

###24952576
BACKGROUND	Omega-3 fatty acids confer beneficial health effects , but North Americans are lacking in their dietary omega-3-rich intake .
BACKGROUND	Supplementation is an alternative to consumption of fish ; however , not all omega-3 products are created equal .
BACKGROUND	The trial objective was to compare the increases in blood levels of omega-3 fatty acids after consumption of four different omega-3 supplements , and to assess potential changes in cardiovascular disease risk following supplementation .
METHODS	This was an open-label , randomized , cross-over study involving thirty-five healthy subjects .
METHODS	Supplements and daily doses ( as recommended on product labels ) were : Concentrated Triglyceride ( rTG ) fish oil : EPA of 650mg , DHA of 450mgEthyl Ester ( EE ) fish oil : EPA of 756mg , DHA of 228mgPhospholipid ( PL ) krill oil : EPA of 150mg , DHA of 90mgTriglyceride ( TG ) salmon oil : EPA of 180mg , DHA of 220mg .
METHODS	Subjects were randomly assigned to consume one of four products , in random order , for a 28-day period , followed by a 4-week washout period .
METHODS	Subsequent testing of the remaining three products , followed by 4-week washout periods , continued until each subject had consumed each of the products .
METHODS	Blood samples before and after supplementation were quantified for fatty acid analysis using gas chromatography , and statistically analysed using ANOVA for repeated measures .
RESULTS	At the prescribed dosage , the statistical ranking of the four products in terms of increase in whole blood omega-3 fatty acid levels was concentrated rTG fish oil > EE fish oil > triglyceride TG salmon oil > PL krill oil .
RESULTS	Whole blood EPA percentage increase in subjects consuming concentrated rTG fish oil was more than four times that of krill and salmon oil .
RESULTS	Risk reduction in several elements of cardiovascular disease was achieved to a greater extent by the concentrated rTG fish oil than by any other supplement .
RESULTS	Krill oil and ( unconcentrated ) triglyceride oil were relatively unsuccessful in this aspect of the study .
CONCLUSIONS	For the general population , the form and dose of omega-3 supplements may be immaterial .
CONCLUSIONS	However , given these results , the form and dose may be important for those interested in reducing their risk of cardiovascular disease .
BACKGROUND	ClinicalTrials.gov : NCT01960660 .

###24343388
OBJECTIVE	The purpose of this study was to compare cosmesis at 3 to 4 months and infection in simple lacerations irrigated with normal saline ( NS ) versus activated chlorine dioxide ( CD ) .
METHODS	This was a prospective , randomized trial of a convenience sample of patients .
METHODS	This study was approved by the institutional review board and Food and Drug Administration as a physician-sponsored trial ( FDA investigational new drug no. 68762 ) .
METHODS	The study was conducted in a large urban , academic emergency department .
METHODS	Patients aged 18 to 100 with simple , uncomplicated lacerations requiring repair that were less than 8 hours old were enrolled .
METHODS	Patients were randomized to receive either NS or CD wound irrigation .
METHODS	Demographics , infection , and cosmesis were analyzed and assessed .
METHODS	Cosmetic outcome was assessed at 3 to 4 months using a visual analog scale ( VAS ) , wound evaluation score ( WES ) , patient VAS ( VASPt ) , and digital imaging VAS by 2 plastic surgeons ( VASPlast ) .
RESULTS	One hundred ninety-three patients were enrolled .
RESULTS	Data analysis was available for 175 cases ( 86 NS and 89 CD ) .
RESULTS	Wound infection follow-up was obtained in 74.9 % of the patients .
RESULTS	The 3 - to 4-month cosmesis follow-up was 37.7 % for VAS/WES , 40.0 % for VASPt , and 37.7 % for VASPlast .
RESULTS	There were no significant differences in demographics , key wound characteristics , infection , adverse reactions , and cosmesis .
CONCLUSIONS	The authors report the use of a novel antimicrobial irrigation solution .
CONCLUSIONS	Chlorine dioxide appears to be a safe biologically acceptable antiseptic wound irrigant that does not appear to interfere with cosmetic outcomes .

###24386491
BACKGROUND	A reduced exercise capacity is associated with increased morbidity and mortality in patients with advanced non-small cell lung cancer ( NSCLC ) .
BACKGROUND	Therapeutic exercise can be beneficial and neuromuscular electrical stimulation ( NMES ) of the quadriceps muscles may represent a practical approach .
BACKGROUND	The primary aim of this study was to determine the acceptability of NMES of the quadriceps to patients with NSCLC used alongside palliative chemotherapy .
BACKGROUND	Secondary aims explored aspects of safety and efficacy of NMES in this setting .
METHODS	Patients with advanced NSCLC due to receive first-line palliative chemotherapy were randomized to usual care with or without NMES .
METHODS	They were asked to undertake 30 minute sessions of NMES , ideally daily , but as a minimum , three times weekly .
METHODS	For NMES to be considered acceptable , it was predetermined that 80 % of patients should achieve this minimum level of adherence .
METHODS	Qualitative interviews were held with a subset of patients to explore factors influencing adherence .
METHODS	Safety was assessed according to the Common Terminology Criteria for Adverse Events .
METHODS	Quadriceps muscle strength , thigh lean mass , and physical activity level were assessed at baseline and after three cycles of chemotherapy .
RESULTS	49 patients ( 28 male , median ( IQR ) age 69 ( 64-75 ) years ) participated .
RESULTS	Of 30 randomized to NMES , 18 were eligible for the primary endpoint , of whom 9 ( 50 % [ 90 % CI , 29 to 71 ] ) met the minimum level of adherence .
RESULTS	Adherence was enhanced by incorporating sessions into a daily routine and hindered by undesirable effects of chemotherapy .
RESULTS	There were no serious adverse events related to NMES , nor significant differences in quadriceps muscle strength , thigh lean mass or physical activity level between groups .
CONCLUSIONS	NMES is not acceptable in this setting , nor was there a suggestion of benefit .
CONCLUSIONS	The need remains to explore NMES in patients with cancer in other settings .
BACKGROUND	Current Controlled Trials ISRCTN 42944026 www.controlled-trials.com/ISRCTN42944026 .

###25842051
OBJECTIVE	To compare the effectiveness of virtual reality-based balance exercises to conventional balance exercises during vestibular rehabilitation in patients with unilateral peripheral vestibular loss ( UVL ) .
METHODS	Assessor-blind , randomized controlled trial .
METHODS	Two acute care university teaching hospitals .
METHODS	Patients with UVL ( N = 71 ) who had dizziness/vertigo , and gait and balance impairment .
METHODS	Patients with UVL were randomly assigned to receive 6 weeks of either conventional ( n = 36 ) or virtual reality-based ( n = 35 ) balance exercises during vestibular rehabilitation .
METHODS	The virtual reality-based group received an off-the-shelf virtual reality gaming system for home exercise , and the conventional group received a foam balance mat .
METHODS	Treatment comprised weekly visits to a physiotherapist and a daily home exercise program .
METHODS	The primary outcome was self-preferred gait speed .
METHODS	Secondary outcomes included other gait parameters and tasks , Sensory Organization Test ( SOT ) , dynamic visual acuity , Hospital Anxiety and Depression Scale , Vestibular Rehabilitation Benefits Questionnaire , and Activities Balance Confidence Questionnaire .
METHODS	The subjective experience of vestibular rehabilitation was measured with a questionnaire .
RESULTS	Both groups improved , but there were no significant differences in gait speed between the groups postintervention ( mean difference , -.03 m/s ; 95 % confidence interval [ CI ] , -.09 to .02 m/s ) .
RESULTS	There were also no significant differences between the groups in SOT scores ( mean difference , .82 % ; 95 % CI , -5.00 % to 6.63 % ) or on any of the other secondary outcomes ( P > .05 ) .
RESULTS	In both groups , adherence to exercise was high ( 77 % ) , but the virtual reality-based group reported significantly more enjoyment ( P = .001 ) , less difficulty with ( P = .009 ) and less tiredness after ( P = .03 ) balance exercises .
RESULTS	At 6 months , there were no significant between-group differences in physical outcomes .
CONCLUSIONS	Virtual reality-based balance exercises performed during vestibular rehabilitation were not superior to conventional balance exercises during vestibular rehabilitation but may provide a more enjoyable method of retraining balance after unilateral peripheral vestibular loss .

###25393603
BACKGROUND	Feedback is a critical component of any educational intervention .
BACKGROUND	When it comes to feedback associated with inhaler technique education , there is a lack of knowledge on its role or its potential to solve the major issue of poor inhaler technique .
OBJECTIVE	This study aims to explore the role of feedback in inhaler technique education and its impact on the inhaler technique of patients over time .
METHODS	A parallel-group , repeated-measures study was conducted in the community pharmacy in which the effectiveness of current best practice inhaler technique education utilising qualitative visual feedback ( Group 1 ) was compared with a combination of qualitative and quantitative visual feedback ( Group 2 ) .
METHODS	The impact of these two interventions on inhaler technique maintenance was evaluated .
METHODS	Community pharmacists were randomly allocated to recruit people with asthma who were using a dry powder inhaler .
METHODS	At Visit 1 their inhaler technique was evaluated and education delivered and they were followed up at Visit 2 ( 1 month later ) .
RESULTS	Both educational interventions resulted in an increase in the proportion of patients with correct inhaler technique : from 4 % to 51 % in Group 1 and from 6 % to 83 % in Group 2 ( Pearson 's Chi-Squared , P = 0.03 , n = 49 , and Pearson 's Chi-Squared , P = 0.01 , n = 48 , respectively ) .
RESULTS	The magnitude of improvement was statistically significantly higher for Group 2 compared with Group 1 ( n = 97 , P = 0.02 , Pearson 's Chi-Square test ) .
CONCLUSIONS	The nature of feedback has an impact on the effectiveness of inhaler technique education with regard to correct inhaler technique maintenance over time .

###25135364
BACKGROUND	Viability seems to be important in preventing ventricular remodeling after acute myocardial infarction ( AMI ) .
BACKGROUND	We investigated the influence of viability , as demonstrated with low-dose dobutamine echocardiography , and the role of early revascularization on the process of left ventricular ( LV ) remodeling after AMI .
METHODS	We retrospectively investigated 224 patients who were initially included in the viability-guided angioplasty after acute myocardial infarction-trial ( VIAMI-trial ) .
METHODS	Patients in the VIAMI-trial did not undergo a primary or rescue percutaneous coronary intervention and were stable in the early in-hospital phase .
METHODS	Patients underwent viability testing within 72hours after AMI .
METHODS	Patients with viability were randomized to an invasive strategy or an ischemia-guided strategy .
METHODS	Follow-up echocardiography was performed at a mean of 205days .
METHODS	In this echocardiographic substudy , patients were divided into three new groups : group 1 , viable and revascularized before follow-up echocardiogram ; group 2 , viable , but medically treated ; and group 3 , non-viable patients .
RESULTS	Group 1 showed preservation of LV volume indices .
RESULTS	The ejection fraction ( EF ) increased significantly from 54.0 % to 57.5 % ( P = 0.047 ) .
RESULTS	Group 2 showed a significant increase in LV volume indices with no improvement in EF ( 53.3 % versus 53.0 % , P = 0.86 ) .
RESULTS	Group 3 showed a significant increase in LV volume indices , with a decrease in EF from 53.5 % to 49.1 % ( P = 0.043 ) .
RESULTS	Multivariate logistic regression analysis indicated the number of viable segments and revascularization during follow-up as independent predictors for EF improvement , especially in patients with lower EF at baseline .
CONCLUSIONS	Viability early after AMI is associated with improvement in LV function after revascularization .
CONCLUSIONS	When viable myocardium is not revascularized , the LV tends to remodel with increased LV volumes , without improvement of EF .
CONCLUSIONS	Absence of viability results in ventricular dilatation and deterioration of EF , irrespective of revascularization status .
BACKGROUND	NCT00149591 ( assigned : 6 September 2005 ) .

###25657106
OBJECTIVE	To evaluate the clinical efficacy of an established programme of occupational therapy in maintaining functional activity and reducing further health risks from inactivity in care home residents living with stroke sequelae .
METHODS	Pragmatic , parallel group , cluster randomised controlled trial .
METHODS	228 care homes ( > 10 beds each ) , both with and without the provision of nursing care , local to 11 trial administrative centres across the United Kingdom .
METHODS	1042 care home residents with a history of stroke or transient ischaemic attack , including those with language and cognitive impairments , not receiving end of life care .
METHODS	114 homes ( n = 568 residents , 64 % from homes providing nursing care ) were allocated to the intervention arm and 114 homes ( n = 474 residents , 65 % from homes providing nursing care ) to standard care ( control arm ) .
METHODS	Participating care homes were randomised between May 2010 and March 2012 .
METHODS	Targeted three month programme of occupational therapy , delivered by qualified occupational therapists and assistants , involving patient centred goal setting , education of care home staff , and adaptations to the environment .
METHODS	Primary outcome at the participant level : scores on the Barthel index of activities of daily living at three months post-randomisation .
METHODS	Secondary outcome measures at the participant level : Barthel index scores at six and 12 months post-randomisation , and scores on the Rivermead mobility index , geriatric depression scale-15 , and EuroQol EQ-5D-3L questionnaire , at all time points .
RESULTS	64 % of the participants were women and 93 % were white , with a mean age of 82.9 years .
RESULTS	Baseline characteristics were similar between groups for all measures , personal characteristics , and diagnostic tests .
RESULTS	Overall , 2538 occupational therapy visits were made to 498 participants in the intervention arm ( mean 5.1 visits per participant ) .
RESULTS	No adverse events attributable to the intervention were recorded .
RESULTS	162 ( 11 % ) died before the primary outcome time point , and 313 ( 30 % ) died over the 12 months of the trial .
RESULTS	The primary outcome measure did not differ significantly between the treatment arms .
RESULTS	The adjusted mean difference in Barthel index score at three months was 0.19 points higher in the intervention arm ( 95 % confidence interval -0.33 to 0.70 , P = 0.48 ) .
RESULTS	Secondary outcome measures also showed no significant differences at all time points .
CONCLUSIONS	This large phase III study provided no evidence of benefit for the provision of a routine occupational therapy service , including staff training , for care home residents living with stroke related disabilities .
CONCLUSIONS	The established three month individualised course of occupational therapy targeting stroke related disabilities did not have an impact on measures of functional activity , mobility , mood , or health related quality of life , at all observational time points .
CONCLUSIONS	Providing and targeting ameliorative care in this clinically complex population requires alternative strategies.Trial registration Current Controlled Trials ISRCTN00757750 .

###24829038
OBJECTIVE	To evaluate the cost-effectiveness of specialized multidisciplinary tinnitus treatment based on cognitive behavioral therapy , compared with care as usual .
METHODS	Randomized controlled trial including an economic evaluation from a health-care and societal perspective , using a one-year time horizon .
METHODS	Audiologic center .
METHODS	A referred sample of 626 patients with tinnitus were eligible for participation .
METHODS	Approximately 492 patients were included in the study .
METHODS	Eighty-six ( 35 % ) of 247 patients in the usual care group , and 74 ( 30 % ) of 245 patients in the specialized care group were lost to follow-up by month 12 .
METHODS	Quality adjusted life years ( QALYs ) as measured with the Health Utilities Index Mark III and cost in US dollars .
RESULTS	Compared with patients receiving usual care , patients who received specialized care gained on average 0.015 QALYs ( 95 % bootstrapped confidence interval [ BCI ] , -0.03 to 0.06 ) .
RESULTS	The incremental costs from a societal perspective are $ 357 ( 95 % BCI , - $ 1,034 to $ 1,785 ) .
RESULTS	The incremental cost per QALY from a societal perspective amounted to $ 24,580 .
RESULTS	The probability that SC is cost-effective from a societal perspective is 58 % for a willingness to pay for a QALY of $ 45,000 .
CONCLUSIONS	Specialized multidisciplinary tinnitus treatment based on cognitive behavioral therapy is cost-effective as compared with usual care .
CONCLUSIONS	Although uncertainty surrounding the incremental costs and effects is considerable , sensitivity analysis indicated that cost-effectiveness results were robust .

###25451017
BACKGROUND	The brain serotonin level is decreased in individuals with autism .
BACKGROUND	Buspirone is a 5-HT ( 1A ) receptor agonist with antiaggressive effects increasing prosocial behaviors .
METHODS	We conducted an 8-week randomized double-blind placebo-controlled clinical trial .
METHODS	Participants included 40 outpatient children and adolescents with autism .
METHODS	The patients took buspirone plus risperidone or risperidone plus placebo during 8 weeks .
METHODS	The patients were assessed at baseline , week 4 , and week 8 using the Aberrant Behavior Checklist-Community Rating Scale .
RESULTS	Eighteen patients in the placebo group and 16 patients in the buspirone group completed this trial .
RESULTS	The mean dose of buspirone was 6.7 ( SD 2.7 ) mg/day .
RESULTS	Irritability subscale score significantly decreased during this trial in both groups ( buspirone group : declined from 25.7 [ SD 5.7 ] to 16.3 [ SD 8.5 ] ; placebo group : declined from 24.7 [ SD 7.6 ] to 18.2 [ SD 7.7 ] ) .
RESULTS	The Cohen d effect size was .45 .
RESULTS	Thirteen ( 81.2 % ) of 16 patients in the buspirone group and 7 ( 38.9 % ) of 18 patients in the placebo group showed a 30 % decline in irritability score .
RESULTS	The relative risk for treatment was 2.1 .
RESULTS	There were no serious adverse effects .
RESULTS	The most common adverse effects in the buspirone group were increased appetite , drowsiness , and fatigue .
CONCLUSIONS	This clinical trial supports that low dose buspirone plus risperidone is more effective than risperidone plus placebo for treating irritability in individuals with autism .

###24975233
OBJECTIVE	To identify which training approach , if any , is most effective for improving perception of frequency-compressed speech .
METHODS	A between-subject design using repeated measures .
METHODS	Forty young adults with normal hearing were randomly allocated to one of four groups : a training group ( sentence or consonant ) or a control group ( passive exposure or test-only ) .
METHODS	Test and training material differed in terms of material and speaker .
RESULTS	On average , sentence training and passive exposure led to significantly improved sentence recognition ( 11.0 % and 11.7 % , respectively ) compared with the consonant training group ( 2.5 % ) and test-only group ( 0.4 % ) , whilst , consonant training led to significantly improved consonant recognition ( 8.8 % ) compared with the sentence training group ( 1.9 % ) , passive exposure group ( 2.8 % ) , and test-only group ( 0.8 % ) .
CONCLUSIONS	Sentence training led to improved sentence recognition , whilst consonant training led to improved consonant recognition .
CONCLUSIONS	This suggests learning transferred between speakers and material but not stimuli .
CONCLUSIONS	Passive exposure to sentence material led to an improvement in sentence recognition that was equivalent to gains from active training .
CONCLUSIONS	This suggests that it may be possible to adapt passively to frequency-compressed speech .

###25234274
BACKGROUND	Clinical practice guidelines ( CPGs ) are not readily implemented in clinical practice .
BACKGROUND	One of the impeding factors is that physical therapists do not hold realistic perceptions of their adherence to CPGs .
BACKGROUND	Peer assessment ( PA ) is an implementation strategy that aims at improving guideline adherence by enhancing reflective practice , awareness of professional performance , and attainment of personal goals .
OBJECTIVE	The purpose of this study was to compare the effectiveness of PA with the usual case discussion ( CD ) strategy on adherence to CPGs for physical therapist management of upper extremity complaints .
METHODS	A single-masked , cluster-randomized controlled trial with pretest-posttest design was conducted .
METHODS	Twenty communities of practice ( n = 149 physical therapists ) were randomly assigned to groups receiving PA or CD , with both interventions consisting of 4 sessions over 6 months .
METHODS	Both PA and CD groups worked on identical clinical cases relevant to the guidelines .
METHODS	Peer assessment focused on individual performance observed and evaluated by peers ; CD focused on discussion .
RESULTS	Guideline adherence was measured with clinical vignettes , reflective practice was measured with the Self-Reflection and Insight Scale ( SRIS ) , awareness of performance was measured via the correlation between perceived and assessed improvement , and attainment of personal goals was measured with written commitments to change .
RESULTS	The PA groups improved more on guideline adherence compared with the CD groups ( effect = 22.52 ; 95 % confidence interval [ 95 % CI ] = 2.38 , 42.66 ; P = .03 ) .
RESULTS	The SRIS scores did not differ between PA and CD groups .
RESULTS	Awareness of performance was greater for the PA groups ( r = .36 ) than for the CD groups ( r = .08 ) ( effect = 14.73 ; 95 % CI = 2.78 , 26.68 ; P = .01 ) .
RESULTS	The PA strategy was more effective than the CD strategy in attaining personal goals ( effect = 0.50 ; 95 % CI = 0.04 , 0.96 ; P = .03 ) .
CONCLUSIONS	Limited validity of clinical vignettes as a proxy measure of clinical practice was a limitation of the study .
CONCLUSIONS	Peer assessment was more effective than CD in improving adherence to CPGs .
CONCLUSIONS	Personal feedback may have contributed to its effectiveness .
CONCLUSIONS	Future research should address the role of the group coach .

###24521364
OBJECTIVE	To examine the relationship between performance on executive function measures and subsequent mobility outcomes in community-dwelling older adults .
METHODS	Randomized controlled clinical trial .
METHODS	Champaign-Urbana , Illinois .
METHODS	Community-dwelling older adults ( N = 179 ; mean age 66.4 ) .
METHODS	A 12-month exercise trial with two arms : an aerobic exercise group and a stretching and strengthening group .
METHODS	Established cognitive tests of executive function ( flanker task , task switching , and a dual-task paradigm ) and the Wisconsin card sort test .
METHODS	Mobility was assessed using the timed 8-foot up and go test and times to climb up and down a flight of stairs .
METHODS	Participants completed the cognitive tests at baseline and the mobility measures at baseline and after 12 months of the intervention .
METHODS	Multiple regression analyses were conducted to determine whether baseline executive function predicted postintervention functional performance after controlling for age , sex , education , cardiorespiratory fitness , and baseline mobility levels .
RESULTS	Selective baseline executive function measurements , particularly performance on the flanker task ( = 0.15-0 .17 ) and the Wisconsin card sort test ( = 0.11-0 .16 ) consistently predicted mobility outcomes at 12 months .
RESULTS	The estimates were in the expected direction , such that better baseline performance on the executive function measures predicted better performance on the timed mobility tests independent of intervention .
CONCLUSIONS	Executive functions of inhibitory control , mental set shifting , and attentional flexibility were predictive of functional mobility .
CONCLUSIONS	Given the literature associating mobility limitations with disability , morbidity , and mortality , these results are important for understanding the antecedents to poor mobility function that well-designed interventions to improve cognitive performance can attenuate .

###24395992
BACKGROUND	Despite the growing penetration of the Internet , little is known about the usage and browsing patterns of those in poverty .
BACKGROUND	We report on a randomized controlled trial that sheds light on the Internet use and browsing patterns among the urban poor .
METHODS	The data come from 312 participants in Boston , Massachusetts , from Click to Connect , a study that examined the impact of an intervention that provided computers , Internet , and training to people from lower socioeconomic position ( SEP ) .
METHODS	Data were gathered through pre - and posttest surveys and Internet use tracking software that generated approximately 13 million network activity files and more than 5.5 million records .
RESULTS	Internet use increased among intervention participants , with most of their time spent on social and participatory media sites or Internet portals .
RESULTS	Differential patterns of use by gender and race/ethnicity were observed .
RESULTS	Purposive searching for health information was low among all participants .
RESULTS	Most of the visits to health-related sites were to local hospitals ' sites suggesting the influence of possible preexisting relationships and trust .
RESULTS	Social networking sites were frequently visited , with three sites enjoying similar popularity among all groups .
CONCLUSIONS	Our data show that the availability of Internet can lead to significant increase in its use among low SEP groups .
CONCLUSIONS	Low SEP members used the Internet for participation and engagement , but the sites visited differed by group .
CONCLUSIONS	Harnessing the power of social networking sites and shareware sites may be a way to increase access to health information .

###24297796
BACKGROUND	The role of human chorionic gonadotropin ( hCG ) supplementation on the intrafollicular steroid milieu has been studied .
OBJECTIVE	The objective of the study was to assess the impact on steroid levels in follicular fluids ( FFs ) after different doses of hCG supplementation to recombinant FSH for controlled ovarian stimulation .
METHODS	This was a prospective randomized dose-response study conducted at Copenhagen University Hospital , Rigshospitalet , Denmark .
METHODS	From 62 in vitro fertilization patients , 334 FFs were selected for analyses .
METHODS	Patients were treated using a GnRH agonist protocol with recombinant FSH 150 IU/d and randomized from stimulation day 1 to supplementation with hCG : D0 , 0 IU/d ; D50 , 50 IU/d ; D100 , 100 IU/d ; and D150 , 150 IU/d .
METHODS	Intrafollicular hormone concentrations in relation to treatment groups , follicular sizes , and embryo quality were measured .
RESULTS	In large follicles , hCG supplementation induced a nearly 3-fold increase of estradiol ( nanomoles per liter ) [ D0 : 1496 ; D50 : 3138 ; D100 : 4338 ; D150 : 4009 ( P < .001 ) ] , a significant 3-fold increase of androstenedione , and a 5-fold increase of T ( nanomoles per liter ) [ D0 : 15 ; D50 : 38 ; D100 : 72 ; D150 : 56 ( P < .001 ) ] .
RESULTS	The estradiol to T ratio decreased significantly , with the lowest ratio in D100 and the highest in D0 .
RESULTS	Large follicles giving rise to good-quality embryos had significantly higher estradiol and progesterone levels and estradiol to T , estradiol to androstenedione , and progesterone to estradiol ratios , compared with small follicles , leading to poor-quality embryos .
CONCLUSIONS	Increasing doses of hCG supplementation markedly stimulated the intrafollicular concentration of both estradiol and androgens , with a shift toward a more androgenic milieu .
CONCLUSIONS	In large follicles with oocytes giving rise to good-quality embryos , the FFs were significantly more estrogenic than in small follicles with oocytes developing into poor quality embryos .

###24939677
OBJECTIVE	The aim of this study was to describe dose regimens , dose escalation and clinical outcomes in TNF - inhibitor ( TNFi ) - naive patients with PsA treated with infliximab in routine rheumatology care .
METHODS	We conducted an observational cohort study based on the nationwide Danish Rheumatologic Database ( DANBIO ) and Center for Rheumatology Research ( ICEBIO ) registries .
METHODS	Stratified by country , characteristics of patients treated with 3 mg infliximab/kg body weight , 3-5 mg/kg or 5 mg/kg every 8 weeks were described .
METHODS	Outcomes were evaluated by ACR 20 % , 50 % and 70 % ( ACR20/50/70 ) responses and European League Against Rheumatism good response after 6 months , disease activity after 12 months , Kaplan-Meier plots and regression analyses .
RESULTS	Four hundred and sixty-two patients ( 376 Danish , 86 Icelandic ) received treatment with infliximab .
RESULTS	In Danish patients , the starting dose was 3 mg/kg in 110 patients ( 29 % ) , 3-5 mg/kg in 157 ( 42 % ) , 5 mg/kg in 38 ( 10 % ) and unregistered in 71 ( 19 % ) .
RESULTS	In Icelandic patients , corresponding numbers were 64 ( 74 % ) , 17 ( 27 % ) , 0 ( 0 % ) and 5 ( 6 % ) .
RESULTS	Patients with a higher body weight received lower doses per kilogram .
RESULTS	Danish patients received higher doses than Icelandic patients at baseline [ median 3.1 ( interquartile range 3.0-3 .8 ) vs 2.3 ( 2.1-2 .9 ) mg/kg , P < 0.05 ] and after 12 months [ 3.3 ( 3.0-4 .5 ) vs 2.9 ( 2.2-3 .5 ) mg/kg , P < 0.0001 ] .
RESULTS	After 12 months , 58 % of Danish and 66 % of Icelandic patients maintained treatment .
RESULTS	Danish patients had shorter drug survival than Icelandic patients ( 1183 vs 483 days ) .
RESULTS	In univariate analyses stratified by country , time until dose escalation , response rates , drug survival and 1-year 's disease activity were independent of starting dose .
RESULTS	Drug survival was shorter among patients not receiving concomitant MTX .
CONCLUSIONS	In clinical practice , > 70 % of Icelandic and Danish PsA patients treated with infliximab received sustained doses below the 5 mg/kg every 8 weeks recommended in international guidelines .
CONCLUSIONS	Lower starting doses did not affect drug survival or response .

###26353424
BACKGROUND	Many studies comparing different intravenous fluid types usually do not use equipotent volumes of 3:1 crystalloid : colloid ratio in such comparisons .
BACKGROUND	Conflicting results emanate from such studies .
BACKGROUND	This study was designed to compare the efficacy of equipotent volumes of crystalloid , colloid and combination of crystalloid/colloid in spinal anaesthesia-induced hypotension prophylaxis .
METHODS	Pregnant women scheduled for elective Caesarean section were prospectively randomized to three groups to each received either 1 500 ml of Ringers lactate , or 500 ml of 6 % pentastarch or a combination of 250 ml of 6 % pentastarch and 750 ml of Ringers lactate intravenous fluid preload , before spinal anaesthesia .
METHODS	Hemodynamic variables were monitored .
RESULTS	First 10 minutes , crystalloid showed better efficacy in hypotension prophylaxis over the other regimen .
RESULTS	In the next 30 minutes however , there were no significant differences between the groups .
CONCLUSIONS	Crystalloids proved more effective than colloid or their combination in hypotension prophylaxis in the first 10 minutes after spinal anaesthesia .

###25471255
OBJECTIVE	Current U.S. guidelines suggest that pregnant women should exercise regularly during pregnancy , and we examined the neurodevelopment of the children whose mothers had taken that advice .
METHODS	This Norwegian study included 188 children whose mothers had followed a structured exercise protocol and 148 control children whose mothers had not .
METHODS	Their cognitive , language and motor skills were assessed at 18 months of age by the Bayley Scales of Infant Development-III and daily life functioning with the Ages and Stages Questionnaire .
RESULTS	No significant differences were found between the two groups .
RESULTS	Subgroup analyses revealed that the children whose mothers had exercised had a slightly lower motor composite score ( mean : 97.6 , 95 % CI : 96.0-99 .2 ) than the control group ( mean : 100.0 , 95 % CI : 98.6-101 .5 ) ( p = 0.03 ) .
RESULTS	Boys in the intervention group had lower fine motor scores ( mean : 10.6 , 95 % CI : 10.3-11 .0 ) than boys in the control group ( mean : 11.5 , 95 % CI : 11.0-11 .9 ) ( p = 0.01 ) .
CONCLUSIONS	Our main finding was that regular moderate exercise during pregnancy does not adversely affect neurodevelopment in children .
CONCLUSIONS	The lower motor scores in the subgroup analyses are probably clinically insignificant , but the lower fine motor scores for boys in the intervention group warrant further research .

###25109096
BACKGROUND	Intimate Partner Violence ( IPV ) is prevalent among recent mothers and negatively impacts their physical and emotional health .
BACKGROUND	Furthermore , the negative influence of IPV on parenting capacity and children 's development is well described .
BACKGROUND	However , it is unclear whether there is any relationship between IPV and method of infant feeding .
BACKGROUND	Little is known about how women who are subjected to IPV make decisions about infant feeding or whether living in this context impacts on their experience of breastfeeding .
BACKGROUND	With what is known about the importance of breastfeeding , particularly for vulnerable populations , research is essential to inform clinical practice and to develop appropriate community support strategies .
METHODS	This paper describes an analysis of data from a pragmatic cluster randomised controlled trial : Improving maternal and child health nurse care for vulnerable mothers ( MOVE ) .
METHODS	The MOVE trial was conducted in the north-western suburbs of Melbourne , Australia from April 2010-April 2011 and involved 80 maternal and child health centres , 160 nurses and 2621 women who completed a survey .
METHODS	Intimate partner violence was measured using the Composite Abuse Scale .
RESULTS	Ninety-six per cent ( n = 2111 ) of participating women initiated breastfeeding , with 80 % ( n = 1776 ) and 74 % ( n = 1537 ) indicating ` any ' breastfeeding at 3 and 6 months respectively .
RESULTS	Respondents tended to be older , well-educated with a household income > $ 70,000 per annum compared to the general population .
RESULTS	The characteristics of women from the IPV and non-IPV groups were similar and together were comparable to all women who gave birth in north-west Melbourne .
RESULTS	The reported prevalence of IPV in this survey was 6.3 % ( n = 138 ) , which may be an underestimate .
RESULTS	Breastfeeding rates did not significantly differ between IPV and non-IPV groups .
CONCLUSIONS	Our findings suggest that women who experience IPV are just as likely to breastfeed as the broader population of women .
CONCLUSIONS	While this analysis provide 's a snapshot of breastfeeding rates for this group of women , it does not capture women 's experience of IPV as it relates to feeding a baby .
CONCLUSIONS	In order to better identify infant feeding in the context of IPV , qualitative research is also necessary to investigate in a way that fully engages victims/survivors , giving them the opportunity to give voice to their experiences .

###24836866
OBJECTIVE	To evaluate efficacy and safety of intravitreal aflibercept injection ( IAI ) in subjects who were previously treated with ranibizumab and/or bevacizumab for active exudative age-related macular degeneration ( AMD ) .
METHODS	Patients ( n = 26 ) were enrolled in a 12-month prospective , interventional , single arm , investigator-initiated study with planned 6-month interim analysis .
METHODS	Patients with active exudative AMD , previously treated with ranibizumab and/or bevacizumab , were treated with 2mg IAI every month for the first 3months , followed by a fixed dosing schedule of 2mg IAI every 2months .
METHODS	The primary study endpoint was the mean absolute change from baseline central subfield thickness ( CST ) at month 12 as measured by SDOCT .
METHODS	Secondary outcomes included mean change from baseline best-corrected visual acuity ( BCVA ) score , percentage of subjects who gained or lost greater than or equal to 15 letters of vision , percentage of subjects who are 20/40 or better , percentage of subjects who are 20/200 or worse , and the incidence of adverse events ( AE ) and serious AEs .
RESULTS	Planned 6-month interim analysis demonstrated a mean decrease in CST of 38.6 m ( p < 0.001 ) and a mean increase in ETDRS BCVA of +5.9 letters ( p < 0.001 ) .
RESULTS	Fifteen percent of subjects experienced a greater than 15-letter improvement in visual acuity , 84.6 % of patients gained visual acuity , and no patient lost 3 lines of vision from baseline .
RESULTS	Forty-two percent of subjects were 20/40 or better , and 11.5 % of subjects were 20/200 or worse at month 6 .
RESULTS	No serious ocular or systemic AEs were encountered .
CONCLUSIONS	IAI-treated eyes demonstrated improved short-term functional and anatomic endpoints in subjects with active exudative AMD switching from previous anti-VEGF treatment when given in a fixed dosing scheme for 6months .
BACKGROUND	NCT01617148 .

###24518147
BACKGROUND	In the immediate postoperative period surgical breast cancer patients can face many problems including functional limitation of the shoulder , edema , pain and depression .
BACKGROUND	Although those symptoms can alleviate during the stages of the therapeutic route , most of the time concur significantly to the everyday life discomforts decreasing sharply the quality of life .
BACKGROUND	Therefore , is essential to pay attention to the functional problems of breast cancer patients in order to ensure a quick and complete physical and psychosocial recovery .
OBJECTIVE	Aim of this study , comparing 2 groups of patients , one that underwent to early physical rehabilitation program ( EPRP ) and one as a control group , is to evaluate : functional improvements of the glenohumeral joint mobility , antalgic effect of EPRP , improvements and/or worsening of quality of life .
METHODS	Randomized controlled study .
METHODS	Inpatient and outpatient clinic , Breast Unit , `` San Giuseppe Moscati '' Hospital , Avellino , Italy .
METHODS	Seventy women planned for Madden 's modified radical mastectomy or for segmental mastectomy with axillary dissection in the period from March 2010 to February 2011 .
METHODS	Patients were randomly assigned to treated and control group .
METHODS	All participants were evaluated before surgery and postoperatively at fifth day , first , sixth and twelfth month .
METHODS	Patients of the treated group , underwent first , to assisted cautious mobilization of hand , wrist and elbow and after drainage removal , to twenty physiotherapy sessions under the guide of a physiotherapist .
RESULTS	Within group statistical analysis evidenced that TG regained normal function at 1 year after surgery while CG was unable to do so for flexion , abduction and internal rotation movements .
RESULTS	TG manifested general and statistically significative improvements in QoL .
RESULTS	Improvements in the grade of pain perceived were observed starting from the first postoperative month .
CONCLUSIONS	Postoperative early physical rehabilitation programme in surgical breast cancer patients surgically treated significantly improves glenohumeral joint mobility , reduces pain and widely improves the quality of life .
CONCLUSIONS	Early rehabilitation plays a key role in the physical and psycho-social recovery for breast cancer patients surgically treated with axillary dissection .

###24863086
OBJECTIVE	To evaluate the effect of sibutramine on weight loss in obese adolescents .
METHODS	A double-blind controlled study lasting 13 months .
METHODS	The study included 73 obese adolescents of both sexes aged between 10 and 18 years .
METHODS	Laboratory tests and imaging studies were performed before , during wash-out , and at the end of 13 months .
RESULTS	The percentage of patients who lost 10 % of their initial weight in the placebo group was 46 % , and in the sibutramine group was 75 % .
RESULTS	When placebo was used , average weight rose by 1.61 kg , and BMI decreased by 0.24 kg/m ( 2 ) whereas with the use of sibutramine , weight decreased by 4.47 kg , and average BMI decreased , 2.38 kg/m ( 2 ) , with p < 0.001 .
CONCLUSIONS	Sibutramine induced significantly more weight loss in obese adolescents compared with placebo , without significant side effects .
CONCLUSIONS	The weight loss curve was different depending on the moment sibutramine was introduced .
CONCLUSIONS	This finding indicates that the best time to start sibutramine is when adhesion begins to fail .

###25560444
OBJECTIVE	To determine if recommending strict rest improved concussion recovery and outcome after discharge from the pediatric emergency department ( ED ) .
METHODS	Patients aged 11 to 22 years presenting to a pediatric ED within 24 hours of concussion were recruited .
METHODS	Participants underwent neurocognitive , balance , and symptom assessment in the ED and were randomized to strict rest for 5 days versus usual care ( 1-2 days rest , followed by stepwise return to activity ) .
METHODS	Patients completed a diary used to record physical and mental activity level , calculate energy exertion , and record daily postconcussive symptoms .
METHODS	Neurocognitive and balance assessments were performed at 3 and 10 days postinjury .
METHODS	Sample size calculations were powered to detect clinically meaningful differences in postconcussive symptom , neurocognitive , and balance scores between treatment groups .
METHODS	Linear mixed modeling was used to detect contributions of group assignment to individual recovery trajectory .
RESULTS	Ninety-nine patients were enrolled ; 88 completed all study procedures ( 45 intervention , 43 control ) .
RESULTS	Postdischarge , both groups reported a 20 % decrease in energy exertion and physical activity levels .
RESULTS	As expected , the intervention group reported less school and after-school attendance for days 2 to 5 postconcussion ( 3.8 vs 6.7 hours total , P < .05 ) .
RESULTS	There was no clinically significant difference in neurocognitive or balance outcomes .
RESULTS	However , the intervention group reported more daily postconcussive symptoms ( total symptom score over 10 days , 187.9 vs 131.9 , P < .03 ) and slower symptom resolution .
CONCLUSIONS	Recommending strict rest for adolescents immediately after concussion offered no added benefit over the usual care .
CONCLUSIONS	Adolescents ' symptom reporting was influenced by recommending strict rest .

###24986781
BACKGROUND	Data on the efficacy of Peg-interferon/ribavirin therapy for chronic hepatitis C are mostly derived from treatment of selected patients enrolled in clinical trials .
BACKGROUND	This study aimed to assess the effectiveness of Peg-interferon/ribavirin therapy in `` real world '' chronic hepatitis C patients in Italy .
METHODS	Independent observational multicentre study including consecutive patients receiving Peg-interferon/ribavirin in the 18 months before ( retrospective phase ) and after ( prospective phase ) the start of the study .
RESULTS	4176 patients were eligible .
RESULTS	The final study population consisted of 2051 patients in the retrospective and 2073 in the prospective phase .
RESULTS	Sustained virological response was achieved by 1036 patients ( 50.5 % ) during the retrospective phase : 325 were genotypes 1/4 ( 34.1 % ) and 684 were genotypes 2/3 ( 67.2 % ) and by 800 patients ( 38.6 % ) during the prospective phase : 300 were genotypes 1/4 ( 28.4 % ) and 473 were genotypes 2/3 ( 51.5 % ) .
RESULTS	During multivariate analysis genotypes 2/3 were significantly associated with higher sustained virological response rates ; cirrhosis and - glutamil-transpeptidase > 2 times the normal limit were associated with poorer response .
CONCLUSIONS	The response to Peg-interferon/ribavirin therapy in `` real world '' clinical practice is distinctly lower than in registration trials .
CONCLUSIONS	The difference in response rates was more pronounced among easy-to-treat than among difficult-to-treat hepatitis C virus genotypes .

###24450890
BACKGROUND	Alzheimer 's disease is characterized by amyloid-beta plaques , neurofibrillary tangles , gliosis , and neuronal loss .
BACKGROUND	Solanezumab , a humanized monoclonal antibody , preferentially binds soluble forms of amyloid and in preclinical studies promoted its clearance from the brain .
METHODS	In two phase 3 , double-blind trials ( EXPEDITION 1 and EXPEDITION 2 ) , we randomly assigned 1012 and 1040 patients , respectively , with mild-to-moderate Alzheimer 's disease to receive placebo or solanezumab ( administered intravenously at a dose of 400 mg ) every 4 weeks for 18 months .
METHODS	The primary outcomes were the changes from baseline to week 80 in scores on the 11-item cognitive subscale of the Alzheimer 's Disease Assessment Scale ( ADAS-cog11 ; range , 0 to 70 , with higher scores indicating greater cognitive impairment ) and the Alzheimer 's Disease Cooperative Study-Activities of Daily Living scale ( ADCS-ADL ; range , 0 to 78 , with lower scores indicating worse functioning ) .
METHODS	After analysis of data from EXPEDITION 1 , the primary outcome for EXPEDITION 2 was revised to the change in scores on the 14-item cognitive subscale of the Alzheimer 's Disease Assessment Scale ( ADAS-cog14 ; range , 0 to 90 , with higher scores indicating greater impairment ) , in patients with mild Alzheimer 's disease .
RESULTS	Neither study showed significant improvement in the primary outcomes .
RESULTS	The modeled difference between groups ( solanezumab group minus placebo group ) in the change from baseline was -0.8 points for the ADAS-cog11 score ( 95 % confidence interval [ CI ] , -2.1 to 0.5 ; P = 0.24 ) and -0.4 points for the ADCS-ADL score ( 95 % CI , -2.3 to 1.4 ; P = 0.64 ) in EXPEDITION 1 and -1.3 points ( 95 % CI , -2.5 to 0.3 ; P = 0.06 ) and 1.6 points ( 95 % CI , -0.2 to 3.3 ; P = 0.08 ) , respectively , in EXPEDITION 2 .
RESULTS	Between-group differences in the changes in the ADAS-cog14 score were -1.7 points in patients with mild Alzheimer 's disease ( 95 % CI , -3.5 to 0.1 ; P = 0.06 ) and -1.5 in patients with moderate Alzheimer 's disease ( 95 % CI , -4.1 to 1.1 ; P = 0.26 ) .
RESULTS	In the combined safety data set , the incidence of amyloid-related imaging abnormalities with edema or hemorrhage was 0.9 % with solanezumab and 0.4 % with placebo for edema ( P = 0.27 ) and 4.9 % and 5.6 % , respectively , for hemorrhage ( P = 0.49 ) .
CONCLUSIONS	Solanezumab , a humanized monoclonal antibody that binds amyloid , failed to improve cognition or functional ability .
CONCLUSIONS	( Funded by Eli Lilly ; EXPEDITION 1 and 2 ClinicalTrials.gov numbers , NCT00905372 and NCT00904683 . )

###24408336
OBJECTIVE	To explore the effect of caffeine on voice , as evidenced by acoustic and aerodynamic measures , based on the fact that caffeine is considered to be a systemic dehydrating agent .
METHODS	The participants in this investigation were 58 females ranging in age from 18 to 35 years , who self-reported normal vocal production .
METHODS	The participants abstained from caffeine ingestion for 24 hours and from ingesting foods and liquids for 12 hours prior to the test .
METHODS	They were randomly assigned to one of two groups , control and experimental , and were individually tested .
METHODS	After the preliminary phase , participants in the experimental group ingested a 100 mg caffeine tablet ; participants in the control group ingested placebo , and followed the same protocol as the experimental group .
METHODS	All participants were retested 30 minutes after ingesting caffeine or placebo .
RESULTS	Differences were not identified in any of the acoustic or aerodynamic measures across both groups .
CONCLUSIONS	These results suggest that a conservative ( 100 mg ) dosage of caffeine may not have an impact on vocal acoustics and aerodynamics .

###24983280
OBJECTIVE	To evaluate the efficacy and safety of carbamazepine , pregabalin , and venlafaxine in patients with painful diabetic neuropathy ( PDN ) .
METHODS	Our study was performed as a randomized , double-blind , parallel-group clinical trial between December 2012 and December 2013 at Kermanshah University of Medical Sciences , Kermanshah , Iran .
METHODS	Two hundred and fifty-seven patients with clinically definite PDN were randomized to receive , carbamazepine , venlafaxine , or pregabalin .
METHODS	The primary outcome was subjective pain as assessed by the visual analogue scale ( VAS ) .
METHODS	Secondary outcomes consisted of sleep , mood , and work interference assessments , and a percentage of patients achieving at least 50 % reduction in pain intensity .
RESULTS	Means of VAS scores for carbamazepine , pregabalin , and venlafaxine treatment groups at the baseline ( 74.5 , 82.3 , and 74.5 ) and endpoint ( 39.6 , 33.4 , and 46.6 ) revealed significant reduction , although pregabalin was more efficacious than carbamazepine , and venlafaxine .
RESULTS	Improvements in means scores of sleep , mood , and work interferences were identified in all treatment groups .
CONCLUSIONS	This study showed the efficacy of venlafaxine , pregabalin , and carbamazepine in pain reduction in patients with diabetic neuropathy , although pregabalin was shown to be superior to carbamazepine , and venlafaxine in relieving pain , no significant superiority was shown between carbamazepine , and venlafaxine .

###24528987
OBJECTIVE	To compare outcomes of thoracoscopic clipping ( TC ) versus transcatheter occlusion ( TO ) for patent ductus arteriosus ( PDA ) .
METHODS	One hundred patients were enrolled in the study from May 2010 to December 2011 .
METHODS	Those patients were randomized into 2 groups : group one received TC , group two received TO .
RESULTS	There were no significant differences concerning width or length of the ductus ( P > 0.05 ) .
RESULTS	However the median age and median weight of patients in the TO group were greater than in the TC group ( P < 0.05 ) .
RESULTS	Mean operative time was 32 12 min in the TC group versus 20 3 min in the TO group ( P < 0.05 ) .
RESULTS	There were no deaths in either group .
RESULTS	There were no complications in the TC group whereas three patients in the TO group had complications and required subsequent operation .
RESULTS	Median postoperative stay was 3.5 days ( IQR : 3.0-4 .3 ) in the TC group versus 3 days ( IQR : 2.0-4 .0 ) in the TO group ( P < 0.05 ) .
RESULTS	There was no residual shunting in either group .
RESULTS	Average cost for one patient was $ 645 232 in the TC group versus $ 1,260 204 in the TO group ( P < 0.001 ) .
CONCLUSIONS	Thoracoscopic clipping is safer than transcatheter occlusion for PDA repair , with the same effectiveness and lower cost .

###24931249
BACKGROUND	Acute effects of physical exercise on the deformational behavior of knee articular cartilage and changes in cartilage volume are definite .
BACKGROUND	However , conclusive effects of different exercises on the loss of articular cartilage volume have not been proved .
BACKGROUND	In this parallel-group randomized controlled trial , we tested whether 12 weeks of swimming , powerstriding , cycling , and running exercises would decrease the cartilage volume significantly and whether there would be a difference in the loss of cartilage volume after different types of exercises .
METHODS	From October 2012 to January 2013 we evaluated 120 healthy volunteer students in Biomechanics Laboratory of Tongji University .
METHODS	Body mass index ( BMI ) , right lower limb strength , and right knee cartilage magnetic resonance imaging ( MRI ) were obtained before exercise .
METHODS	MRI were conducted in East Hospital .
METHODS	The study was approved by Tongji University Ethical Committee , all subjects were randomly assigned to the running , powerstriding , cycling , swimming , and control groups by a drawing of lots .
METHODS	Each group contained 24 samples .
METHODS	At the end of 12 weeks of regular exercises , the same measurement procedures were applied .
METHODS	Cartilage volume was calculated with OSIRIS software based on the quantitative-MRI .
METHODS	Pre - and post-exercise comparisons were carried out using paired t-tests and one-way analysis of variance ( ANOVA ) was used to compare differences of cartilage volume loss between groups with Student-Newman-Keuls procedure for multiple comparisons .
RESULTS	Running , cycling , and swimming groups resulted in a significant decrease in BMI .
RESULTS	The quadriceps peak torque increased significantly in the swimming and cycling groups .
RESULTS	Total cartilage volume significantly decreased in the running and cycling groups after 12 weeks of training , without any significant change in the nonimpact swimming , low-impact powerstriding , and control groups .
RESULTS	Loss of total cartilage volume in the running and cycling groups were 2.21 % ( 3.03 ) and 1.50 % ( 0.42 ) .
CONCLUSIONS	Twelve weeks of regular physical exercises ( i.e. , running and cycling ) decrease the total knee cartilage volume .
CONCLUSIONS	Swimming and powerstriding are recommended for the healthy youth .
CONCLUSIONS	This finding suggests that articular cartilage has the functional adaptation for exercises , and some sports could be the risk factors for the initiation of osteoarthritis ( OA ) in young healthy adults .

###24318654
BACKGROUND	Sleep disruption and fatigue are ubiquitous among cancer patients and are sources of stress that may compromise treatment outcomes .
BACKGROUND	Previously , we showed that a cognitive behavioral stress management ( CBSM ) intervention reduced anxiety and other stress-related processes in women undergoing primary treatment for breast cancer .
OBJECTIVE	This study examined secondary outcomes from a CBSM intervention trial for women with early-stage breast cancer to test if CBSM would improve sleep quality and fatigue among these patients at a single site in southern Florida .
OBJECTIVE	CBSM-related effects have already been demonstrated for indicators of psychosocial adaptation ( e.g. , general and cancer-related anxiety ) .
METHODS	Patients were randomized to CBSM ( n = 120 ) or a 1-day psychoeducation control group ( n = 120 ) .
METHODS	The Pittsburgh Sleep Quality Index ( PSQI ) and Fatigue Symptom Inventory were completed prior to randomization and 6 and 12months after the baseline assignment .
RESULTS	In latent growth analyses , women in CBSM reported greater improvements in PSQI sleep quality scores than controls , although there were no significant differences between conditions on PSQI total scores .
RESULTS	Women in CBSM also reported greater reductions in fatigue-related daytime interference than controls , though there were no significant differences in changes in fatigue intensity .
RESULTS	Changes in sleep quality were associated with changes in fatigue .
CONCLUSIONS	Future work may consider integrating sleep and fatigue content into stress management interventions for women with early-stage breast cancer .

###25134860
BACKGROUND	Glycemic control in the perioperative period decreases mortality and morbidity , but data are scarce with regard to the effects of glucose control approaches on survival .
BACKGROUND	We assessed long-term survival in patients treated with 2 strategies of glucose control after first-time isolated coronary artery bypass graft .
METHODS	In a previously published trial , patients were prospectively randomized to strict ( 90-120 mg/dL ) or liberal ( 121-180 mg/dL ) glucose control protocols .
METHODS	The aim of this study was to assess long-term data on survival and health-related quality of life based on the original prospective randomized study population .
RESULTS	No differences were found in cumulative survival between the strict ( 95.5 % ) and liberal ( 93.5 % ) target range groups ( log-rank = 0.32 , p = 0.57 ) over a mean follow-up of 40.0 4.4 months .
RESULTS	Physical health-related quality of life significantly improved in all patients from baseline to 6 months after surgery ( F = 17.73 , p < 0.001 ) , and there were no differences in improvement of health-related quality of life between the 2 target range groups ( F = 0.15 , p = 0.70 ) .
CONCLUSIONS	These results support our previous findings and indicate that a liberal glycemic control strategy after coronary artery bypass leads to survival rates and improvements in health-related quality of life that are similar to those achieved with a strict target range .
CONCLUSIONS	In addition , the liberal strategy is superior in glucose control and target range management .

###25419871
OBJECTIVE	Asthma is often poorly controlled .
OBJECTIVE	Home visitation by community health workers ( CHWs ) to improve control among adults has not been adequately evaluated .
OBJECTIVE	To test the hypothesis that CHW home visits for adults with uncontrolled asthma improve outcomes relative to usual care .
METHODS	Randomized parallel group study with 1-year follow-up , conducted 2008 through 2011 at homes of low-income adults aged 18 to 65 years with uncontrolled asthma living in King County , Washington .
METHODS	The CHWs provided a mean of 4.9 home visits during a 1-year period to assess asthma control , self-management , and home environment and to support asthma self-management practices .
METHODS	Primary prespecified outcomes were symptom-free days ( number of 24-hour periods in prior 2 weeks without asthma symptoms ) , asthma-related quality of life ( Mini Asthma Quality of Life Questionnaire ) , and asthma-related unscheduled health care use .
RESULTS	Of 463 individuals who completed eligibility screening , 443 were eligible , 366 participated ( 177 in intervention and 189 in control groups ) , and 333 completed the study ( 91 % ) .
RESULTS	The intervention group had significantly greater increases in mean symptom-free days per 2 weeks ( 2.02 [ 95 % CI , 0.94-3 .09 ] ; P < .001 ) and quality of life ( 0.50 [ 95 % CI , 0.28-0 .71 ] points ; P < .001 ) relative to the control group , adjusted for age , sex , race/ethnicity , and education level .
RESULTS	The number needed to treat to increase symptom-free days by 2 days per 2 weeks was 7.4 and to improve quality of life by 0.5 points was 2.6 .
RESULTS	Mean urgent health care use episodes in the past 12 months decreased significantly and similarly in both groups , from a mean of 3.46 to 1.99 episodes in the intervention group ( mean change , -1.47 [ 95 % CI , -2.28 to -0.67 ] ; P < .001 ) and from a mean of 3.30 to 1.96 episodes in the control group ( mean change , -1.34 [ 95 % CI , -2.00 to -0.72 ] ; P < .001 ) ( P = .83 comparing groups ) .
CONCLUSIONS	The provision of in-home asthma self-management support by CHWs to low-income adults with uncontrolled asthma improves asthma control and quality of life but not unscheduled health care use .
CONCLUSIONS	Additional studies are needed to confirm these findings and determine the value of wider implementation of this approach .
BACKGROUND	clinicaltrials.gov Identifier : NCT01783028 .

###24838476
OBJECTIVE	Maternal smoking during pregnancy adversely affects offspring lung development , with lifelong decreases in pulmonary function and increased asthma risk .
OBJECTIVE	In a primate model , vitamin C blocked some of the in-utero effects of nicotine on lung development and offspring pulmonary function .
OBJECTIVE	To determine if newborns of pregnant smokers randomized to receive daily vitamin C would have improved results of pulmonary function tests ( PFTs ) and decreased wheezing compared with those randomized to placebo .
METHODS	Randomized , double-blind trial conducted in 3 sites in the Pacific Northwest between March 2007 and January 2011 .
METHODS	One hundred fifty-nine newborns of randomized pregnant smokers ( 76 vitamin C treated and 83 placebo treated ) and 76 newborns of pregnant nonsmokers were studied with newborn PFTs .
METHODS	Follow-up assessment including wheezing was assessed through age 1 year , and PFTs were performed at age 1 year .
METHODS	Pregnant women were randomized to receive vitamin C ( 500 mg/d ) ( n = 89 ) or placebo ( n = 90 ) .
METHODS	The primary outcome was measurement of newborn pulmonary function ( ratio of the time to peak tidal expiratory flow to expiratory time [ TPTEF : TE ] and passive respiratory compliance per kilogram [ Crs/kg ] ) within 72 hours of age .
METHODS	Secondary outcomes included incidence of wheezing through age 1 year and PFT results at age 1 year .
METHODS	A subgroup of pregnant smokers and nonsmokers had genotyping performed .
RESULTS	Newborns of women randomized to vitamin C ( n = 76 ) , compared with those randomized to placebo ( n = 83 ) , had improved pulmonary function as measured by TPTEF : TE ( 0.383 vs 0.345 [ adjusted 95 % CI for difference , 0.011-0 .062 ] ; P = .006 ) and Crs/kg ( 1.32 vs 1.20 mL/cm H2O/kg [ 95 % CI , 0.02-0 .20 ] ; P = .01 ) .
RESULTS	Offspring of women randomized to vitamin C had significantly decreased wheezing through age 1 year ( 15/70 [ 21 % ] vs 31/77 [ 40 % ] ; relative risk , 0.56 [ 95 % CI , 0.33-0 .95 ] ; P = .03 ) .
RESULTS	There were no significant differences in the 1-year PFT results between the vitamin C and placebo groups .
RESULTS	The effect of maternal smoking on newborn lung function was associated with maternal genotype for the 5 nicotinic receptor ( rs16969968 ) ( P < .001 for interaction ) .
CONCLUSIONS	Supplemental vitamin C taken by pregnant smokers improved newborn PFT results and decreased wheezing through 1 year in the offspring .
CONCLUSIONS	Vitamin C in pregnant smokers may be an inexpensive and simple approach to decrease the effects of smoking in pregnancy on newborn pulmonary function and respiratory morbidities .
BACKGROUND	clinicaltrials.gov Identifier : NCT00632476 .

###25902613
BACKGROUND	Researchers face myriad challenges in the design and implementation of randomized , controlled trials .
BACKGROUND	Apart from summaries on limitations , these challenges are rarely documented in detail to inform future research projects .
OBJECTIVE	To describe methodological challenges encountered during randomized , controlled trials ( WinFood Study ) designed to assess the efficacy of locally produced complementary foods based on traditional animal-source foods ( edible termites and spiders ) to support growth and nutritional status in Kenyan and Cambodian infants .
METHODS	In a randomized , controlled design , infants received WinFood or corn-soy blend ( CSB ) for 9 months from 6 to 15 months of age .
METHODS	Lean mass accrual and blood nutrition indicators ( lipid profile , iron and zinc status ) were measured cross-sectionally at 9 and 15 months of age , respectively .
METHODS	Lean mass was determined by measuring deuterium oxide enrichment in saliva samples following a standard dose of deuterium solution ( 0.5 g/kg body weight ) to infants .
METHODS	Blood nutrition indicators were determined following the drawing of 3 mL of blood by venipuncture .
RESULTS	Challenges included rapid depletion of food rations , high rate of loss to follow-up , delayed ethical approval , lack of local food-processing capacity , low capacity among staff to draw blood , and lack of laboratory capacity to perform both deuterium oxide and micronutrient status measurements .
RESULTS	Spillage of deuterium oxide solution during dosing was a major challenge in the Kenya context .
RESULTS	A high rate of morbidity among infants made some assessments very difficult , especially drawing of blood and saliva samples .
CONCLUSIONS	The challenges were largely contextual .
CONCLUSIONS	Improvement of local laboratory capacity , training of staff and sensitization of the communities and the Ethics Review Committee are highly recommended .

###25468946
OBJECTIVE	To identify novel metabolic markers for diabetes development in American Indians .
METHODS	Using an untargeted high-resolution liquid chromatography-mass spectrometry , we conducted metabolomics analysis of study participants who developed incident diabetes ( n = 133 ) and those who did not ( n = 298 ) from 2,117 normoglycemic American Indians followed for an average of 5.5 years in the Strong Heart Family Study .
METHODS	Relative abundances of metabolites were quantified in baseline fasting plasma of all 431 participants .
METHODS	Prospective association of each metabolite with risk of developing type 2 diabetes ( T2D ) was examined using logistic regression adjusting for established diabetes risk factors .
RESULTS	Seven metabolites ( five known and two unknown ) significantly predict the risk of T2D .
RESULTS	Notably , one metabolite matching 2-hydroxybiphenyl was significantly associated with an increased risk of diabetes , whereas four metabolites matching PC ( 22:6 / 20:4 ) , ( 3S ) -7 - hydroxy-2 ' ,3 ' ,4 ' ,5 ' ,8 - pentamethoxyisoflavan , or tetrapeptides were significantly associated with decreased risk of diabetes .
RESULTS	A multimarker score comprising all seven metabolites significantly improved risk prediction beyond established diabetes risk factors including BMI , fasting glucose , and insulin resistance .
CONCLUSIONS	The findings suggest that these newly detected metabolites may represent novel prognostic markers of T2D in American Indians , a group suffering from a disproportionately high rate of T2D .

###24731301
BACKGROUND	Cervical radicular syndrome ( CRS ) due to a herniated disc can be safely treated by surgical decompression of the spinal root .
BACKGROUND	In the vast majority of cases this relieves pain in the arm and restores function .
BACKGROUND	However , conservative treatment also has a high chance on relieving symptoms .
BACKGROUND	The objective of the present study is to evaluate the ( cost - ) effectiveness of surgery versus prolonged conservative care during one year of follow-up , and to evaluate the timing of surgery .
BACKGROUND	Predisposing factors in favour of one of the two treatments will be evaluated .
METHODS	Patients with disabling radicular arm pain , suffering for at least 2 months , and an MRI-proven herniated cervical disc will be randomised to receive either surgery or prolonged conservative care with surgery if needed .
METHODS	The surgical intervention will be an anterior discectomy or a posterior foraminotomy that is carried out according to usual care .
METHODS	Surgery will take place within 2-4 weeks after randomisation .
METHODS	Conservative care starts immediately after randomisation .
METHODS	The primary outcome measure is the VAS for pain or tingling sensations in the arm one year after randomisation .
METHODS	In addition , timing of surgery will be studied by correlating the primary outcome to the duration of symptoms .
METHODS	Secondary outcome measures encompass quality of life , costs and perceived recovery .
METHODS	Predefined prognostic factors will be evaluated .
METHODS	The total follow-up period will cover two years .
METHODS	A sample size of 400 patients is needed .
METHODS	Statistical analysis will be performed using a linear mixed model which will be based on the ` intention to treat ' principle .
METHODS	In addition , a new CRS questionnaire for patients will be developed , the Leiden Cervical Radicular Syndrome Functioning ( LCRSF ) scale .
CONCLUSIONS	The outcome will contribute to better decision making for the treatment of cervical radicular syndrome .
BACKGROUND	NTR3504 .

###24446539
BACKGROUND	There are no direct comparisons of paliperidone extended-release ( ER ) , aripiprazole and ziprasidone in efficacy and metabolic influence in patients with first-episode schizophrenia .
OBJECTIVE	The present study examined the efficacy and metabolic influence of paliperidone ER , aripiprazole and ziprasidone in patients with first-episode schizophrenia in China .
METHODS	Subjects were recruited from outpatient and 254 patients entered the trial .
METHODS	These patients received treatment randomly with paliperidone ER , aripiprazole and ziprasidone and were assessed at baseline , 13 , 26 and 52 weeks , respectively with Positive and Negative Syndrome Scale ( PANSS ) , 7-item Clinical Global Impressions-Severity ( CGI-S ) , anthropometric ( weight , body mass index and waist circumference ) and metabolic ( fasting blood glucose , HbA1c , cholesterol , high density lipoproteins ( HDL ) , low density lipoproteins and triglycerides ) measures .
RESULTS	A total of 203 patients completed the trial .
RESULTS	Paliperidone group had significant greater reduction in PANSS than aripiprazole group and ziprasidone group from 13 weeks , although the a reduction in PANSS of each group was more than 20 % .
RESULTS	There was no difference in CGI-S among the three groups , and all three groups had a significant reduction from baseline in CGI-S .
RESULTS	Aripiprazole group increased in weight and body mass index despite no statistical change in waist circumference .
RESULTS	Other two groups showed no changes in anthropometric measure .
RESULTS	At the end of the study , two glucose metabolic indices ( fasting blood glucose and HbA1c ) of aripiprazole group were significantly higher than that of baseline .
RESULTS	In lipid metabolism , aripiprazole group reduced triglycerides significantly and had no changes in other indices .
RESULTS	Paliperidone group reduced HDL and increased triglycerides despite no changes in glucose metabolism .
RESULTS	Ziprasidone group also had no significant changes in glucose metabolism , but reduced cholesterol , low density lipoproteins and increased HDL .
RESULTS	Furthermore , 22 subjects in three groups reached the diagnostic criteria of metabolic syndrome .
CONCLUSIONS	Paliperidone ER , aripiprazole and ziprasidone are effective in treating first-episode schizophrenia , and the ranking of efficacy from high to low is paliperidone ER > aripiprazole > ziprasidone .
CONCLUSIONS	Paliperidone ER can impair lipid metabolism potentially but had no influence on glucose metabolism .
CONCLUSIONS	Aripiprazole can damage glucose metabolism and has little influence on lipid metabolism .
CONCLUSIONS	Ziprasidone is considered an atypical antipsychotic with no evidence of harm to glucose and lipid metabolism .

###25401417
BACKGROUND	Several studies have indicated that a restrictive erythrocyte transfusion strategy is as safe as a liberal one in critically ill patients , but there is no clear evidence to support the superiority of any perioperative transfusion strategy in patients with cancer .
METHODS	In a randomized , controlled , parallel-group , double-blind ( patients and outcome assessors ) superiority trial in the intensive care unit of a tertiary oncology hospital , the authors evaluated whether a restrictive strategy of erythrocyte transfusion ( transfusion when hemoglobin concentration < 7 g/dl ) was superior to a liberal one ( transfusion when hemoglobin concentration < 9 g/dl ) for reducing mortality and severe clinical complications among patients having major cancer surgery .
METHODS	All adult patients with cancer having major abdominal surgery who required postoperative intensive care were included and randomly allocated to treatment with the liberal or the restrictive erythrocyte transfusion strategy .
METHODS	The primary outcome was a composite endpoint of mortality and morbidity .
RESULTS	A total of 198 patients were included as follows : 101 in the restrictive group and 97 in the liberal group .
RESULTS	The primary composite endpoint occurred in 19.6 % ( 95 % CI , 12.9 to 28.6 % ) of patients in the liberal-strategy group and in 35.6 % ( 27.0 to 45.4 % ) of patients in the restrictive-strategy group ( P = 0.012 ) .
RESULTS	Compared with the restrictive strategy , the liberal transfusion strategy was associated with an absolute risk reduction for the composite outcome of 16 % ( 3.8 to 28.2 % ) and a number needed to treat of 6.2 ( 3.5 to 26.5 ) .
CONCLUSIONS	A liberal erythrocyte transfusion strategy with a hemoglobin trigger of 9 g/dl was associated with fewer major postoperative complications in patients having major cancer surgery compared with a restrictive strategy .

###25407020
BACKGROUND	Opioid substitution treatment ( OST ) has multiple benefits for heroin injectors and is an evidence-based major component of international treatment .
BACKGROUND	The current qualitative study sought to explore participants ' attitudes to and reasons for participating in a feasibility randomised trial in primary care offering ` same day ' OST ( methadone ) for injecting heroin users compared to usual care .
METHODS	Twenty injecting heroin users ( 8 intervention and 12 controls ; 16 males and 4 females ) were interviewed ; purposive sampling was used to select a maximum variation sample from those who agreed ; and analysis used thematic methods .
RESULTS	Motivation to join the trial included the need to secure treatment set against some ambivalence due to previous negative experiences of trying to obtain OST .
RESULTS	Positive effects of securing methadone via the trial , included self-reported improvements in health and self-care ; reduction in crime , stress and drug use .
RESULTS	Completing the baseline questionnaires at recruitment appeared to enhance motivation for treatment for all participants .
RESULTS	For some control participants , this motivation seemed to increase a sense of self-efficacy and cognitive dissonance generated was resolved by seeking treatment from their GP .
RESULTS	Self-determination theory suggests that behaviour change may have been initiated during the recruitment appointment , resulting in an increased determination to seek treatment amongst control participants .
CONCLUSIONS	Taking part in the ` script in a day ' trial enabled participants in the intervention arm to gain same-day access to methadone and reduce their drug use .
CONCLUSIONS	For those in the control arm , completing the baseline questionnaires at recruitment appeared to create cognitive dissonance between their current health state and own aspirations , so increasing motivation for treatment .
CONCLUSIONS	Over 50 % obtained and were still in receipt of OST ( methadone or buprenorphine ) at the 3month follow-up .
CONCLUSIONS	We suggest that a regular ` health evaluation ' for injecting heroin users not in treatment , paired with low-barrier access to treatment , may be a way of exploring this and encouraging more into obtaining OST more quickly and at the best time for them .
CONCLUSIONS	This intervention should be delivered without pressure for change .
BACKGROUND	This trial is registered with International Standard Randomised Controlled Trial Number Register : SCript In a Day for injecting drug users : feasibility trial : ISRCTN16846554 .

###25126036
OBJECTIVE	A variety of sensory stimuli relieve restless legs syndrome symptoms .
OBJECTIVE	Because systematic evaluations of sensory stimulation in restless legs syndrome are largely lacking , we performed a randomized crossover study to evaluate the effect of external sensory stimulation on restless legs syndrome symptoms .
METHODS	Eighteen patients underwent 3 consecutive suggestive immobilization tests with the order of the following 3 conditions randomly assigned : no electrical stimulation ( condition 1 ) , tactile and proprioceptive sensory stimulation ( condition 2 ) , and tactile sensory stimulation only ( condition 3 ) .
METHODS	Restless legs syndrome symptoms were quantified by visual analog scales , and periodic leg movements during wake were measured .
RESULTS	Baseline visual analogue scale score was 4.5 ( range 0-60 ) in condition 1 , 10.5 ( range 0-96 ) in condition 2 , and 8.5 in condition 3 ( p = 0.21 ) .
RESULTS	There was a tendency towards a higher maximum visual analogue scale score and visual analogue scale score at the end of the suggested immobilization test in the conditions with tactile sensory stimulation , though not significant ( p = 0.74 and p = 0.29 , respectively ) .
RESULTS	Fifteen patients suffered from periodic leg movements during wake .
RESULTS	Median indices were 18 ( range 0-145 ) in condition 1 , 26 ( range 0-190 ) in condition 2 , and 49 ( range 0-228 ) in condition 3 ( p = 0.76 ) .
CONCLUSIONS	We found a tendency towards less leg discomfort in the conditions in which an external sensory input was applied .
CONCLUSIONS	This potential benefit of sensory stimuli on restless legs syndrome severity merits further investigation as this could open new ways towards a better pathophysiological understanding and non-pharmacological treatments .

###25692781
OBJECTIVE	It is unclear whether an intensive program of weight loss combined with exercise prevents the onset of knee pain among those at high risk .
OBJECTIVE	We examined whether an intensive lifestyle intervention ( ILI ) prevents incident knee pain compared with a diabetes mellitus support and education ( DSE ) comparison group among overweight adults with diabetes mellitus .
METHODS	We conducted a secondary analysis of the Action for Health in Diabetes ( Look AHEAD ) study , which is a randomized intervention trial of adults who were obese and had type 2 diabetes mellitus starting in 2001 .
METHODS	We studied a subcohort of 2,889 subjects who reported no knee pain at baseline but were at high risk due to obesity .
METHODS	Risk ratios ( RRs ) were calculated to examine the association of ILI versus DSE with incident knee pain at year 1 and year 4 .
METHODS	All analyses were adjusted for potential confounders .
RESULTS	Age , sex , and body mass index were similar among ILI and DSE participants with no knee pain at baseline .
RESULTS	At year 1 , ILI participants were 15 % less likely to develop knee pain compared with DSE participants ( RR 0.85 , 95 % confidence interval 0.74-0 .98 ) .
RESULTS	At year 4 , this difference decreased to 5 % and was no longer statistically significant .
CONCLUSIONS	An ILI of diet and exercise may prevent the development of knee pain among those at high risk in the short term .
CONCLUSIONS	Health care providers may consider recommending diet and exercise as a means to prevent the development of knee pain among those at high risk .

###24475275
BACKGROUND	The effect of maraviroc on the maintenance and the function of HIV-1-specific T cell responses remains unknown .
METHODS	Subjects recently infected with HIV-1 were randomized to receive anti-retroviral treatment with or without maraviroc intensification for 48 weeks , and were monitored up to week 60 .
METHODS	PBMC and in vitro-expanded T cells were tested for responses to the entire HIV proteome by ELISpot analyses .
METHODS	Intracellular cytokine staining assays were conducted to monitor the ( poly ) - functionality of HIV-1-specific T cells .
METHODS	Analyses were performed at baseline and week 24 after treatment start , and at week 60 ( 3 months after maraviroc discontinuation ) .
RESULTS	Maraviroc intensification was associated with a slower decay of virus-specific T cell responses over time compared to the non-intensified regimen in both direct ex-vivo as well as in in-vitro expanded cells .
RESULTS	The effector function profiles of virus-specific CD8 T cells were indistinguishable between the two arms and did not change over time between the groups .
CONCLUSIONS	Maraviroc did not negatively impact any of the measured parameters , but was rather associated with a prolonged maintenance of HIV-1-specific T cell responses .
CONCLUSIONS	Maraviroc , in addition to its original effect as viral entry inhibitor , may provide an additional benefit on the maintenance of virus-specific T cells which may be especially important for future viral eradication strategies .

###25124964
OBJECTIVE	Low level laser ( light ) therapy ( LLLT ) has been demonstrated to promote hair growth in males .
OBJECTIVE	A double-blind randomized controlled trial was undertaken to define the safety and physiologic effects of LLLT on females with androgenic alopecia .
METHODS	Forty-seven females ( 18-60 years old , Fitzpatrick I-IV , and Ludwig-Savin Baldness Scale I-2 , I-3 , I-4 , II-1 , II-2 baldness patterns ) were recruited .
METHODS	A transition zone scalp site was selected ; hairs were trimmed to 3mm height ; the area was tattooed and photographed .
METHODS	The active group received a `` TOPHAT655 '' unit containing 21 , 5mW diode lasers ( 6555nm ) and 30 LEDS ( 65520nm ) , in a bicycle-helmet like apparatus .
METHODS	The placebo group unit appeared identical , containing incandescent red lights .
METHODS	Patients treated at home every other day16 weeks ( 60 treatments , 67J/cm ( 2 ) irradiance/25minute treatment , 2.9 J dose ) , with follow up and photography at 16 weeks .
METHODS	A masked 2.85 cm ( 2 ) photographic area was evaluated by another blinded investigator .
METHODS	The primary endpoint was the percent increase in hair counts from baseline .
RESULTS	Forty-two patients completed the study ( 24 active , 18 sham ) .
RESULTS	No adverse events or side effects were reported .
RESULTS	Baseline hair counts were 228.2133.4 ( N = 18 ) in the sham and 209.6118.5 ( N = 24 ) in the active group ( P = 0.642 ) .
RESULTS	Post Treatment hair counts were 252.1143.3 ( N = 18 ) in the sham group and 309.9166.6 ( N = 24 ) in the active group ( P = 0.235 ) .
RESULTS	The change in hair counts over baseline was 23.930.1 ( N = 18 ) in the sham group and 100.353.4 ( N = 24 ) in the active group ( P < 0.0001 ) .
RESULTS	The percent hair increase over the duration of the study was 11.0548.30 ( N = 18 ) for the sham group and 48.0717.61 ( N = 24 ) for the active group ( P < 0.001 ) .
RESULTS	This demonstrates a 37 % increase in hair growth in the active treatment group as compared to the placebo group .
CONCLUSIONS	LLLT of the scalp at 655nm significantly improved hair counts in women with androgenetic alopecia at a rate similar to that observed in males using the same parameters .

###24886036
BACKGROUND	Idiopathic interstitial pneumonias such as idiopathic pulmonary fibrosis or fibrotic nonspecific interstitial pneumonia are irreversible progressive pulmonary diseases that often have fatal outcomes .
BACKGROUND	Although the etiology of idiopathic interstitial pneumonias is not yet fully understood , anti-fibrotic and anti-inflammatory agents have shown limited therapeutic effectiveness .
BACKGROUND	Reactive oxygen species and their cytotoxic effects on the lung epithelial cells have been reported to participate in the pathophysiology of the disease .
BACKGROUND	Because superoxide dismutase catalyzes the detoxification of reactive oxygen species , we developed lecithinized superoxide dismutase for the treatment of patients with idiopathic interstitial pneumonias .
METHODS	A multicenter , randomized , placebo-controlled trial was conducted as a pilot study to investigate the safety and effectiveness of 40 or 80 mg lecithinized superoxide dismutase in patients with progressive idiopathic interstitial pneumonias who presented with either idiopathic pulmonary fibrosis or corticosteroid-resistant fibrotic nonspecific interstitial pneumonia and showed arterial oxygen tension compatible with stage III or IV on the Japanese severity grading scale for idiopathic interstitial pneumonias .
METHODS	Before and following infusion of lecithinized superoxide dismutase for 28 days , the primary endpoint of forced vital capacity and the secondary endpoints of lactate dehydrogenase , surfactant protein-A , surfactant protein-D and Krebs von den Lungen-6 levels were measured in the serum .
RESULTS	The primary endpoint of forced vital capacity did not improve significantly in the lecithinized superoxide dismutase groups in comparison with the placebo group .
RESULTS	The secondary endpoints of lactate dehydrogenase and surfactant protein-A levels were significantly attenuated by 28 days in the higher-dose ( 80 mg ) group .
RESULTS	However , these changes returned to the baseline levels by 56 days after the cessation of lecithinized superoxide dismutase .
RESULTS	Adverse events and mortality in the drug-treated groups did not differ from those in the placebo group .
CONCLUSIONS	Treatment with lecithinized superoxide dismutase is safe and improves the levels of serum markers such as lactate dehydrogenase and surfactant protein-A in patients with advanced idiopathic interstitial pneumonias with severe respiratory dysfunction .
CONCLUSIONS	Considering the results of the current study , further investigations into the effects and treatment potential of long-term administration of lecithinized superoxide dismutase may be warranted .
BACKGROUND	University hospital Medical Information Network ( UMIN ) clinical trials registry no. 000000752 .

###24693632
OBJECTIVE	To evaluate the desensitizing efficacy of 2 % sodium fluoride solution ( NaF ) , diode laser ( DL ) , a DL and NaF association and a solution of hydroxyl-ethyl-methacrylate and glutaraldehyde ( HEMA-G : Gluma desensitizer ) in cervical dentin hypersensitivity ( CDH ) .
METHODS	262 teeth of 24 subjects ( 16 females and eight males ; age 21 to 64 years , mean 38 years ) , each having at least two CHD teeth for each quadrant , were included in this prospective , split mouth , clinical study .
METHODS	Teeth of each oral quadrant were randomized in four groups ( SG ) to study the effectiveness of NaF ( SG-1 ) , of DL ( SG-2 ) NaF-DL combination ( SG-3 ) and HEMA-G ( SG-4 ) .
METHODS	The subjects were asked to rate the sensitivity experienced during air stimulation by placing a mark on a visual analogue scale ( VAS ) before treatment ( baseline ) , immediately after treatment , and after 1 , and 6 months .
RESULTS	The outcomes showed a significant reduction of discomfort compared to baseline values for teeth of SG-3 immediately post treatment ( 82.6 % ) ( P < 0.001 ) , after 1 month ( 69.5 % ) ( P < 0.001 ) and after 6 months ( 60.8 % ) ( P < 0.001 ) , respectively , compared with the reduction scores of 51.6 % ( P < 0.001 ) , 29.7 % ( P < 0.05 ) and 4.7 % ( P > 0.05 ) , recorded for SG-1 ; 72.2 % , ( P < 0.001 ) , 62.5 % ( P < 0.001 ) , and 47.2 % ( P < 0.05 ) , recorded for SG-2 ; 77.4 % ( P < 0.001 ) , 56.1 % ( P < 0.001 ) , and 27.3 % ( P < 0.05 ) , recorded for SG-4 .

###24489841
BACKGROUND	NIMH Project Accept ( HPTN 043 ) is a community - randomized trial to test the safety and efficacy of a community-level intervention designed to increase testing and lower HIV incidence in Tanzania , Zimbabwe , South Africa and Thailand .
BACKGROUND	The evaluation design included a longitudinal study with community members to assess attitudinal and behavioral changes in study outcomes including HIV testing norms , HIV-related discussions , and HIV-related stigma .
METHODS	A cohort of 657 individuals across all sites was selected to participate in a qualitative study that involved 4 interviews during the study period .
METHODS	Baseline and 30-month data were summarized according to each outcome , and a qualitative assessment of changes was made at the community level over time .
RESULTS	Members from intervention communities described fewer barriers and greater motivation for testing than those from comparison communities .
RESULTS	HIV-related discussions in intervention communities were more grounded in personal testing experiences .
RESULTS	A change in HIV-related stigma over time was most pronounced in Tanzania and Zimbabwe .
RESULTS	Participants in the intervention communities from these two sites attributed community-level changes in attitudes to project specific activities .
CONCLUSIONS	The Project Accept intervention was associated with more favorable social norms regarding HIV testing , more personal content in HIV discussions in all study sites , and qualitative changes in HIV-related stigma in two of five sites .

###24382970
OBJECTIVE	To evaluate the efficacy of autologous cytokine-induced killer ( CIK ) cells in patients with renal cell carcinoma ( RCC ) .
METHODS	20 patients diagnosed with TNM stage I or II RCC were randomly divided into two groups , a CIK cell treatment group and a control group .
METHODS	The endpoint was progression-free survival ( PFS ) evaluated by Kaplan-Meier analyses .
RESULTS	CD3 ( + ) , CD3 ( + ) / CD8 ( + ) , CD3 ( + ) / CD4 ( + ) , and CD3 ( + ) / CD56 ( + ) levels increased after CIK cell culture ( P < 0.01 ) .
RESULTS	The median PFS in CIK cell treatment group was significantly longer than that in control group ( PFS , 32.2 months versus 21.6 months ; log-rank , P = 0.032 ) , all patients were alive during the course of followup , and there are no statistically significant differences between two groups in OS ( log-rank , P = 0.214 ) .
RESULTS	Grade III or greater adverse events were not observed .
CONCLUSIONS	CIK cells treatment could prolong survival in patients with RCC after radical nephrectomy and showed acceptable curative effect with potential enhancement of cellular immune function .
CONCLUSIONS	This trial is registered with Clinicaltrials.gov NCT01799083 .

###25104527
BACKGROUND	At the end of 2 previous trials , an excess of stroke and bleeding was observed in patients with AF randomized to a new oral anticoagulant ( NOAC ) who transitioned to a vitamin K antagonist ( VKA ) .
OBJECTIVE	The ENGAGE AF-TIMI 48 ( Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48 ) trial compared once-daily edoxaban to warfarin for stroke prevention in patients with AF .
OBJECTIVE	An end-of-trial transition plan was developed to minimize the risks of stroke due to inadequate anticoagulation and bleeding from excessive anticoagulation during this critical period .
METHODS	All patients on the blinded study drug at the trial 's conclusion were included in this analysis .
METHODS	In pre-specified analyses , stroke , bleeding , and death that occurred through 30 days after the end-of-trial visit were stratified by randomized treatment allocation and open-label anticoagulant selected post-trial .
RESULTS	Of the 13,642 patients taking the blinded study drug at the end of the trial , 9,304 ( 68.2 % ) were transitioned to open-label VKA and 4,258 patients ( 31.2 % ) to an NOAC .
RESULTS	There were 21 strokes evenly distributed across the 3 randomized treatment arms : warfarin 7 ( 1.90 % / year ) , edoxaban high dose 7 ( 1.89 % / year ) , edoxaban low dose 7 ( 1.85 % / year ) .
RESULTS	Major bleeding was also similar across the 3 treatment arms : warfarin 11 ( 2.98 % / year ) , edoxaban high dose 10 ( 2.69 % / year ) , edoxaban low dose 18 ( 4.76 % / year ) .
RESULTS	In patients transitioned to VKA , 85 % of patients had at least 1 INR 2 by day 14 after the transition and 99 % by day 30 .
CONCLUSIONS	The ENGAGE AF-TIMI 48 transition plan protected patients from an excess of thrombotic and bleeding events and should be helpful in clinical practice when patients are transitioned between oral anticoagulants .
CONCLUSIONS	( Global Study to Assess the Safety and Effectiveness of Edoxaban [ DU-176b ] vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation [ EngageAFTIMI48 ] ; NCT00781391 ) .

###25052347
OBJECTIVE	This prospective multicenter study examined whether elevated fecal calprotec tin ( FC ) concentrations after stopping TNF-blocking therapy can predict clinical or endoscopic relapse .
OBJECTIVE	In addition , we evaluated the impact of histological remission on the relapse risk .
METHODS	We enrolled inflammatory bowel disease ( IBD ) patients who were in clinical , endoscopic , and FC-based ( < 100 g/g ) remission after a minimum 11 months of TNF-blocking therapy .
METHODS	The patients were followed-up for 12 months after the discontinuation of TNF-blocking therapy .
METHODS	FC was collected monthly for the first 6 months and thereafter every second month .
METHODS	Ileocolonoscopy was performed at inclusion , at 4 months , at the study end , and at the time of clinical relapse .
RESULTS	Of 52 enrolled patients , 49 ( 16 Crohn 's disease , 33 ulcerative colitis/IBD unclassified ) provided the stool samples requested and comprised the study group .
RESULTS	During the follow-up , 15/49 ( 31 % ) relapsed , whereas 34 ( 69 % ) remained in remission .
RESULTS	Patients relapsing showed constantly elevated FC levels for a median of 94 ( 13-317 ) days before the relapse .
RESULTS	Significant increase in median FC levels was seen 2 ( p = 0.0014 ) , 4 ( p = 0.0056 ) , and 6 ( p = 0.0029 ) months before endoscopic relapse .
RESULTS	Constantly normal FC concentrations during the follow-up were highly predictive for clinical and endoscopic remission .
RESULTS	Normal FC concentrations in patients with remission were associated with histological remission .
CONCLUSIONS	FC seems to increase and remain elevated before clinical or endoscopic relapse , suggesting that it can be used as a surrogate marker for predicting and identifying patients requiring close follow-up in clinical practice .

###25298573
OBJECTIVE	Experimental pain models in human healthy volunteers are advantageous for early evaluation of analgesics .
OBJECTIVE	All efforts to develop nonsteroidal anti-inflammatory drugs ( NSAIDs ) which are devoid of gastrointestinal and cardiovascular system effects are still far from achieving a breakthrough .
OBJECTIVE	Hence we evaluated the analgesic activity of an ayurvedic drug , Boswellia serrata by using validated human pain models which has shown its analgesic activity both in-vitro and preclinical studies to evaluate the analgesic activity of single oral dose ( 125 mg , 2 capsules ) of Boswellia serrata compared to placebo using mechanical pain model in healthy human subjects .
METHODS	After taking written informed consent , twelve healthy subjects were randomized ( 1:1 ) to receive single oral dose of Boswellia serrata ( Shallaki ( ) ) 125 mg , 2 capsules or identical placebo in a crossover design .
METHODS	Mechanical pain was assessed using Ugo basile analgesymeter ( by Randall Selitto test ) at baseline and at 1 hr , 2 hrs and 3 hrs after test drug administration .
METHODS	Pain Threshold force and time and Pain Tolerance force and time were evaluated .
METHODS	Statistical analysis was done by paired t-test .
RESULTS	Twelve healthy volunteers have completed the study .
RESULTS	Mean percentage change from baseline in Pain Threshold force and time with Boswellia serrata when compared to placebo had significantly increased [ Force : 9.7 11.0 vs 2.9 3.4 ( P = 0.05 ) and time : 9.7 10.7 vs 2.8 3.4 ( P = 0.04 ) ] at third hr .
RESULTS	Mean Percentage change from baseline in Pain Tolerance force and time with Boswellia serrata when compared to placebo had significantly ( P 0.01 ) increased at 1 hr , 2 hrs and 3 hrs .
CONCLUSIONS	In the present study , Boswellia serrata significantly increased the Pain Threshold and Pain Tolerance force and time compared to placebo .
CONCLUSIONS	Both study medications were well tolerated .
CONCLUSIONS	Further multiple dose studies may be needed to establish the analgesic efficacy of the drug .

###24909348
BACKGROUND	First - and second-year medical students have limited exposure to basic surgical skills .
BACKGROUND	An introductory , comprehensive , simulation-based curriculum in basic laparoscopic skills may improve medical students ' knowledge and technical and nontechnical skills and may raise their interest in a career in surgery .
BACKGROUND	The purpose of this study was to ( 1 ) design a comprehensive , simulation-based training curriculum ( STC ) aimed to introduce junior medical students to basic laparoscopic skills and ( 2 ) compare structured and supervised learning and practice to a self-directed approach .
METHODS	Twenty-four , pre-clerkship medical students were allocated randomly to either a supervised ( STC ) or a self-directed learning and practice ( SDL ) group .
METHODS	Participants in the STC group received structured training in cognitive , and basic technical and nontechnical domains of laparoscopic surgery , whereas the SDL group was invited to engage in SDL in the same domains .
RESULTS	At post-training assessment , basic knowledge about laparoscopic surgery , and attitudes toward nontechnical skills were equivalent between STC and SDL groups .
RESULTS	The STC group outperformed ( meanstandard deviation ) the SDL group on a peg transfer task ( 5813 vs 8119seconds ; P = .005 ) .
RESULTS	Participants in the STC group showed significant within-group improvements in knowledge , technical skill , and in 4 of 5 domains of nontechnical skills , whereas participants in the SDL group showed significant within-group improvement in technical skill and in 1 of 5 domains of nontechnical skills .
CONCLUSIONS	Participation in the STC resulted in significant gains in knowledge , technical skill , and attitudes toward nontechnical skills .
CONCLUSIONS	Exposure of junior medical students to this curriculum before their clinical rotations is expected to enhance learning , maintain motivation , and increase interest in surgery as a future career .

###24304365
BACKGROUND	Tricuspid annular plane systolic excursion ( TAPSE ) is a widely used clinical measure of right ventricular ( RV ) systolic performance .
BACKGROUND	However , postsurgical changes in the pattern of RV contraction may limit the utility of TAPSE for assessing global RV function .
BACKGROUND	We retrospectively examined pre - and postoperative TAPSE and RV fractional area change ( FAC ) in patients undergoing 3 different types of aortic valve replacement ( AVR ) .
METHODS	Fifty-two patients enrolled in the Placement of AoRTic TraNscathetER Valve Trial at our institution were randomized to receive open AVR or transcatheter AVR ( TAVR ) by either the transapical or transfemoral access routes .
METHODS	Thirty-seven of these patients had analyzable transthoracic echocardiography ( TTE ) before and after AVR .
METHODS	Using M-mode echocardiography , TAPSE was measured in the apical four-chamber view .
METHODS	Using two-dimensional echocardiography , RV FAC was measured in the apical four-chamber view .
RESULTS	The mean change in TAPSE was -0.70.6 cm for open AVR ( P = 0.002 ) , -0.20.4 cm for transapical TAVR ( P = 0.26 ) , and 0.10.5 cm for transfemoral TAVR ( P = 0.64 ) .
RESULTS	The mean change in RV FAC was -15 % for open AVR ( P = 0.91 ) , 24 % for transapical TAVR ( P = 0.37 ) , and 710 % for transfemoral TAVR ( P = 0.07 ) .
CONCLUSIONS	The normal pattern of RV contraction was unchanged by transapical and transfemoral TAVR , while open AVR led to a significant decrease in TAPSE with preserved RV FAC .
CONCLUSIONS	Thus , RV FAC is a preferable method for assessing RV function in the postoperative patient .

###25432250
BACKGROUND	The objective of this 2-arm parallel single-center trial was to compare placement time and numbers of failures of mandibular lingual retainers bonded with an indirect procedure vs a direct bonding procedure .
METHODS	Sixty-four consecutive patients at the postgraduate orthodontic clinic of the University of Geneva in Switzerland scheduled for debonding and mandibular fixed retainer placement were randomly allocated to either an indirect bonding procedure or a traditional direct bonding procedure .
METHODS	Eligibility criteria were the presence of the 4 mandibular incisors and the 2 mandibular canines , and no active caries , restorations , fractures , or periodontal disease of these teeth .
METHODS	The patients were randomized in blocks of 4 ; the randomization sequence was generated using an online randomization service ( www.randomization.com ) .
METHODS	Allocation concealment was secured by contacting the sequence generator for treatment assignment ; blinding was possible for outcome assessment only .
METHODS	Bonding time was measured for each procedure .
METHODS	Unpaired t tests were used to assess differences in time .
METHODS	Patients were recalled at 1 , 2 , 4 , and 6months after bonding .
METHODS	Mandibular fixed retainers having at least 1 composite pad debonded were considered as failures .
METHODS	The log-rank test was used to compare the Kaplan-Meier survival curves of both procedures .
METHODS	A test of proportion was applied to compare the failures at 6months between the treatment groups .
RESULTS	Sixty-four patients were randomized in a 1:1 ratio .
RESULTS	One patient dropped out at baseline after the bonding procedure , and 3 patients did not attend the recalls at 4 and 6months .
RESULTS	Bonding time was significantly shorter for the indirect procedure ( 32131seconds , meanSD ) than for the direct procedure ( 40140seconds ) ( per protocol analysis of 63 patients : mean difference = 80seconds ; 95 % CI = 62.4-98 .1 ; P < 0.001 ) .
RESULTS	The 6-month numbers of failures were 10 of 31 ( 32 % ) with the indirect technique and 7 of 29 ( 24 % ) with the direct technique ( log rank : P = 0.35 ; test of proportions : risk difference = 0.08 ; 95 % CI = -0.15 to 0.31 ; P = 0.49 ) .
RESULTS	No serious harm was observed except for plaque accumulation .
CONCLUSIONS	Indirect bonding was statistically significantly faster than direct bonding , with both techniques showing similar risks of failure .
BACKGROUND	This trial was not registered .
METHODS	The protocol was not published before trial commencement .
BACKGROUND	No funding or conflict of interest to be declared .

###24717890
BACKGROUND	Internal nasal valve collapse is a preventable complication of rhinoplasty , for which the spreader graft is the gold standard .
BACKGROUND	More recently , the spreader flap technique has been espoused as an alternative to spreader grafting .
BACKGROUND	Here , we evaluated the efficacy of this technique in a randomized trial setting .
METHODS	The autospreader was used in 32 patients who were candidates for primary rhinoplasty ; 34 who did not undergo a spreader flap procedure were recruited as a control group .
METHODS	Acoustic rhinometry was used in every patient preoperatively and 1 year postoperatively .
METHODS	Average volume and minimal cross-sectional area ( MCA ) of the nose and findings were collected .
METHODS	Also , the pre - and postoperative patients ' subjective assessment about their satisfaction from their appearance and nasal obstruction were evaluated according to visual analog scale ( VAS ) .
RESULTS	Among the study group patients , 46 ( 69.7 % ) were female and 20 ( 30.3 % ) were male subjects .
RESULTS	Their mean age was 50/5 6/24 years .
RESULTS	The difference in MCA in the control group was -0.1 and +0.6 ( on right and left sides , respectively ) , and in the spreader flap group it was -0.03 and +0.05 , which showed an increase in MCA in the left side and a decrease in the opposite side of both groups .
RESULTS	However , their difference was not statistically significant ( p = 0.50 ) .
RESULTS	Also , the differences between preoperative and postoperative VAS were not significant in either nasal obstruction ( p = 0.68 ) and cosmetic satisfaction ( p = 0.38 ) .
CONCLUSIONS	Spreader flap is an attractive technique in preserving the middle vault in nasal plastic surgery .
CONCLUSIONS	However , its effect needs more evaluation .

###24289512
BACKGROUND	The Protocolized Care for Early Septic Shock study is a randomised , multicentre , prospective , three-arm , parallel-group trial of alternative resuscitation strategies for early septic shock .
OBJECTIVE	To state our analysis plan for trial data .
METHODS	Our plan is to guide data collection and analysis using pre-existing definitions and testing , with local consensus-based efforts where needed .
METHODS	We examine protocolised care ( two experimental approaches ) and compare this to usual `` wild type '' care .
RESULTS	Our plan is to address three aims ( clinical efficacy , biology of illness and recovery , and costs and cost-effectiveness ) and four hypotheses , and we specify rules for handling data and determining outcomes .
CONCLUSIONS	By using measures to maintain study conduct and analysis rigour , we hope to improve understanding of early septic shock resuscitation and care of patients .

###25440230
OBJECTIVE	Cluster randomized trials ( CRTs ) are increasingly used to evaluate quality improvement interventions aimed at health care providers .
OBJECTIVE	In trials testing emergency department ( ED ) interventions , migration of emergency physicians ( EPs ) between hospitals is an important concern , as contamination may affect both internal and external validity .
OBJECTIVE	We hypothesized that geographically isolating EDs would prevent migratory contamination in a CRT designed to increase ED delivery of tissue plasminogen activator ( tPA ) in stroke ( the INSTINCT trial ) .
METHODS	INSTINCT was a prospective , cluster randomized , controlled trial .
METHODS	Twenty-four Michigan community hospitals were randomly selected in matched pairs for study .
METHODS	Contamination was defined at the cluster level , with substantial contamination defined a priori as greater than 10 % of EPs affected .
METHODS	Nonadherence , total crossover ( contamination + nonadherence ) , migration distance , and characteristics were determined .
RESULTS	Three hundred seven EPs were identified at all sites .
RESULTS	Overall , 7 ( 2.3 % ) changed study sites .
RESULTS	One moved between control sites , leaving 6 ( 2.0 % ) total crossovers .
RESULTS	Of these , 2 ( 0.7 % ) moved from intervention to control ( contamination ) ; and 4 ( 1.3 % ) moved from control to intervention ( nonadherence ) .
RESULTS	Contamination was observed in 2 of 12 control sites , with 17 % and 9 % contamination of the total site EP workforce at follow-up , respectively .
RESULTS	Average migration distance was 42 miles for all EPs moving in the study and 35 miles for EPs moving from intervention to control sites .
CONCLUSIONS	The mobile nature of EPs should be considered in the design of quality improvement CRTs .
CONCLUSIONS	Increased reporting of contamination in CRTs is encouraged to clarify thresholds and facilitate CRT design .

###24842200
OBJECTIVE	To investigated the effect of a hyperoncotic CPB-prime with hydroxyethyl starch ( HES ) 6 % ( 130/0 .4 ) on extravascular lung water ( EVLW ) and post-pump cardiac and pulmonary functions .
METHODS	This study plan approved by the hospital ethics committee review .
METHODS	In 40 randomized patients undergoing elective coronary artery bypass graft surgery ( CABG ) , a colloid prime ( COP :42.5 mmHg , HES-group , n = 20 ) and a crystalloid prime ( Ringer 's lactate , crystalloid group , n = 20 ) of equal volume were compared with respect to the effects on cardiopulmonary function .
METHODS	Cardiac index ( CI ) , mean arterial pressure ( MAP ) , pulmonary capillary wedge pressure ( PCWP ) , systemic vascular resistance index ( SVRI ) , pulmonary artery pressure ( PAP ) , pulmonary vascular resistance index ( PVRI ) , alveolo-arterial oxygen difference ( AaDO2 ) , pulmonary shunt fraction ( Qs/QT ) , extravascular lung water ( EVLW ) , COP , fluid balance and body weight were evaluated peri-operatively .
RESULTS	Pre-operative demographic and clinical data , CPB-time , crossclamp time and the number of anastomoses were comparable for both groups .
RESULTS	During CPB , COP was reduced by 22 % in the HES-group [ ( 16.7 3.9 ) vs ( 21.5 2.2 ) mmHg , P < 0.05 ] while it was reduced by more than 50 % of the pre-CPB value [ 10.7 2.0 vs ( 22.7 1.9 ) mmHg , P < 0.05 ] in the crystalloid group ( P < 0.05 HES-group vs. crystalloid group ) .
RESULTS	Post-CPB EVLW was unchanged in the HES-group but it was elevated by 21 % in the crystalloid group ( P < 0.05 HES-group vs crystalloid group ) , CI was higher in the HES-group [ ( 3.3 0.3 ) vs ( 2.7 0.7 ) L/min , P < 0.05 ] .
RESULTS	Fluid balance was less in the HES-group ( 715 544 vs 1 951 487 , P < 0.05 ) .
RESULTS	Post-operative weight gain could be prevented in the HES-group but not in the crystalloid group ( 1.4 1.1 vs -0.3 1.3 , P < 0.05 ) .
RESULTS	No significant differences were seen for MAP , PAP , PCWP , SVRI , PVRI , AaDO2 and ( Qs/QT ) between the two groups at any time .
CONCLUSIONS	Hyperoncotic CPB-prime using HES 6 % improves CI and prevents EVLW accumulation in the early post-pump period , while pulmonary function is unchanged .

###24283222
BACKGROUND	Schizophrenia is a highly heterogeneous disorder with positive and negative symptoms being characteristic manifestations of the disease .
BACKGROUND	While these two symptom domains are usually construed as distinct and orthogonal , little is known about the longitudinal pattern of negative symptoms and their linkage with the positive symptoms .
BACKGROUND	This study assessed the temporal interplay between these two symptom domains and evaluated whether the improvements in these symptoms were inversely correlated or independent with each other .
METHODS	This post hoc analysis used data from a multicenter , randomized , open-label , 1-year pragmatic trial of patients with schizophrenia spectrum disorder who were treated with first - and second-generation antipsychotics in the usual clinical settings .
METHODS	Data from all treatment groups were pooled resulting in 399 patients with complete data on both the negative and positive subscale scores from the Positive and Negative Syndrome Scale ( PANSS ) .
METHODS	Individual-based growth mixture modeling combined with interplay matrix was used to identify the latent trajectory patterns in terms of both the negative and positive symptoms .
METHODS	Pearson correlation coefficients were calculated to examine the relationship between the changes of these two symptom domains within each combined trajectory pattern .
RESULTS	We identified four distinct negative symptom trajectories and three positive symptom trajectories .
RESULTS	The trajectory matrix formed 11 combined trajectory patterns , which evidenced that negative and positive symptom trajectories moved generally in parallel .
RESULTS	Correlation coefficients for changes in negative and positive symptom subscale scores were positive and statistically significant ( P < 0.05 ) .
RESULTS	Overall , the combined trajectories indicated three major distinct patterns : ( 1 ) dramatic and sustained early improvement in both negative and positive symptoms ( n = 70 , 18 % ) , ( 2 ) mild and sustained improvement in negative and positive symptoms ( n = 237 , 59 % ) , and ( 3 ) no improvement in either negative or positive symptoms ( n = 82 , 21 % ) .
CONCLUSIONS	This study of symptom trajectories over 1 year shows that changes in negative and positive symptoms were neither inversely nor independently related with each other .
CONCLUSIONS	The positive association between these two symptom domains supports the notion that different symptom domains in schizophrenia may depend on each other through a unified upstream pathological disease process .

###24481570
OBJECTIVE	Depression symptoms are now recognized to be the predominant cause of disability for bipolar disorder ( BD ) patients .
OBJECTIVE	The treatment strategies for the depressed phase of BD remain more anecdotal than data-based .
OBJECTIVE	Olanzapine has been investigated as an alternative to antidepressants and a mood stabilizer for acute bipolar depression .
OBJECTIVE	The purpose of this study was to assess the efficacy of olanzapine monotherapy for bipolar I depression .
METHODS	Sixty-eight patients with bipolar I depression were randomly assigned to treatment with olanzapine ( mean final dose 14.4 mg/day ) ( n = 34 ) or placebo ( n = 34 ) in a double-blind parallel-group study design .
METHODS	Planned assessments included Montgomery-Asberg Depression Rating Scale ( MADRS ) , Young Mania Rating Scale ( YMRS ) , Clinical Global Impressions-Severity of Illness scale ( CGI-S ) , Clinical Global Impressions-Improvement scale ( CGI-I ) , Hamilton Depression scale ( HAMD ) , Hamilton Anxiety scale ( HAMA ) , and Treatment Emergent Symptom Scale ( TESS ) .
RESULTS	Of the 68 patients who were randomly assigned , 57 ( 83.8 % ) completed treatments .
RESULTS	Improvements in MADRS total score , CGI-S , CGI-I , and HAMD in the olanzapine group were significantly greater relative to those in the placebo group during the 8-week follow-up period ( p < 0.001 , p = 0.0017 , p = 0.007 , and p < 0.001 , respectively ) .
RESULTS	Rates of categorical treatment response and remission in the olanzapine group ( 50.0 % and 35.3 % , respectively ) were significantly higher than those in the placebo group ( 20.6 % , p = 0.011 and 11.8 % , p = 0.022 , respectively ) .
RESULTS	At the 8-week treatment , the mean weight and the total cholesterol , triglyceride , and low-density lipoprotein cholesterol levels increased significantly in the olanzapine group ( p = 0.037 , p = 0.029 , p = 0.030 , and p = 0.028 , respectively ) .
CONCLUSIONS	Olanzapine is effective in the treatment of bipolar I depression but is associated with significant metabolic side effects .

###24687169
OBJECTIVE	Metformin treatment is associated with improved outcome after myocardial infarction in patients with diabetes .
OBJECTIVE	In animal experimental studies metformin preserves left ventricular function .
OBJECTIVE	To evaluate the effect of metformin treatment on preservation of left ventricular function in patients without diabetes presenting with ST-segment elevation myocardial infarction ( STEMI ) .
METHODS	Double-blind , placebo-controlled study conducted among 380 patients who underwent primary percutaneous coronary intervention ( PCI ) for STEMI at the University Medical Center Groningen , The Netherlands , between January 1 , 2011 , and May 26 , 2013 .
METHODS	Metformin hydrochloride ( 500 mg ) ( n = 191 ) or placebo ( n = 189 ) twice daily for 4 months .
METHODS	The primary efficacy measure was left ventricular ejection fraction ( LVEF ) after 4 months , assessed by magnetic resonance imaging .
METHODS	A secondary efficacy measure was the N-terminal pro-brain natriuretic peptide ( NT-proBNP ) concentration after 4 months .
METHODS	The incidence of major adverse cardiac events ( MACE ; the combined end point of death , reinfarction , or target-lesion revascularization ) was recorded until 4 months as a secondary efficacy measure .
RESULTS	At 4 months , all patients were alive and none were lost to follow-up .
RESULTS	LVEF was 53.1 % ( 95 % CI , 51.6 % -54.6 % ) in the metformin group ( n = 135 ) , compared with 54.8 % ( 95 % CI , 53.5 % -56.1 % ) ( P = .10 ) in the placebo group ( n = 136 ) .
RESULTS	NT-proBNP concentration was 167 ng/L in the metformin group ( interquartile range [ IQR ] , 65-393 ng/L ) and 167 ng/L in the placebo group ( IQR , 74-383 ng/L ) ( P = .66 ) .
RESULTS	MACE were observed in 6 patients ( 3.1 % ) in the metformin group and in 2 patients ( 1.1 % ) in the placebo group ( P = .16 ) .
RESULTS	Creatinine concentration ( 79 mol/L [ IQR , 70-87 mol/L ] vs 79 mol/L [ IQR , 72-89 mol/L ] , P = .61 ) and glycated hemoglobin ( 5.9 % [ IQR , 5.6 % -6.1 % ] vs 5.9 % [ IQR , 5.7 % -6.1 % ] , P = .15 ) were not significantly different between both groups .
RESULTS	No cases of lactic acidosis were observed .
CONCLUSIONS	Among patients without diabetes presenting with STEMI and undergoing primary PCI , the use of metformin compared with placebo did not result in improved LVEF after 4 months .
CONCLUSIONS	The present findings do not support the use of metformin in this setting .
BACKGROUND	clinicaltrials.gov Identifier : NCT01217307 .

###25223724
OBJECTIVE	This phase III , 52-week study compared fostamatinib with placebo ( for 24 weeks ) in patients with active rheumatoid arthritis ( RA ) and an inadequate response to methotrexate ( MTX ) therapy .
METHODS	Patients taking MTX were randomized ( 1:1:1 ) to receive fostamatinib 100 mg twice daily for 52 weeks ( group A ) , fostamatinib 100 mg twice daily for 4 weeks and then 150 mg once daily ( group B ) , or placebo for 24 weeks and then fostamatinib 100 mg twice daily ( group C ) .
METHODS	At week 24 , the co-primary end points were change from baseline in the American College of Rheumatology 20 % ( ACR20 ) improvement response rates and change in the modified total Sharp/van der Heijde score of radiographic damage ( SHS ) .
RESULTS	In this study , 918 patients were randomized and received 1 dose of study drug ( fostamatinib or placebo ) ; the demographic and baseline clinical characteristics were well balanced .
RESULTS	Following treatment with both fostamatinib regimens , a statistically significant difference in the ACR20 improvement response was achieved at week 24 as compared with that in patients receiving placebo ( 49.0 % [ group A ] and 44.4 % , [ group B ] versus 34.2 % ; P < 0.001 and P = 0.006 , respectively ) , but there was no statistically significant difference in the SHS between either fostamatinib group and placebo ( P = 0.25 and P = 0.17 , respectively ) .
RESULTS	The most common adverse events in patients in groups A , B , and C were hypertension ( 15.8 % , 15.1 % , and 3.9 % , respectively ) and diarrhea ( 13.9 % , 15.1 % , and 3.9 % , respectively ) .
RESULTS	Elevated blood pressure ( 140/90 mm Hg ) occurred at 1 visit in 44.2 % , 41.6 % , and 19.3 % of patients in each respective group .
CONCLUSIONS	With the use of either fostamatinib regimen in patients with RA , statistically significant , but not clinically significant , improvements in the ACR20 improvement response over placebo were achieved at 24 weeks , whereas a significant difference in the SHS was not seen .
CONCLUSIONS	The overall level of response to treatment with fostamatinib was lower than had been observed in the phase II program , but similar adverse events were reported .

###25073881
BACKGROUND	Despite the use of evidence-based preventive measures , delirium affects about 40 % of patients following cardiac surgery with the potential for serious clinical complications and anxiety for caregivers .
BACKGROUND	There is some evidence that family involvement as a core component of delirium management may be beneficial since familiarity helps patients stay in contact with reality , however , this merits further investigation .
BACKGROUND	There is also currently a gap in the scientific literature regarding objective indicators that could enhance early detection and monitoring of delirium .
BACKGROUND	Therefore , this randomized pilot trial examines the acceptability , feasibility , and preliminary efficacy of an experimental nursing intervention to help family caregivers manage post-cardiac surgery delirium in their relatives .
BACKGROUND	It also explores the validity of a new and innovative measure that has potential as an indicator for delirium .
METHODS	In this two-group randomized pilot study ( n = 30 ) , the control group will receive usual care and the intervention group will receive the experimental intervention aimed at reducing delirium severity .
METHODS	The intervention nurse 's objective will be to foster the family caregiver 's self-efficacy in behaving in a supportive manner during delirium episodes .
METHODS	Data will be collected from standard delirium assessment scales and a novel measure of delirium , i.e. , cerebral oximetry obtained using near infrared spectroscopy , as well as medical records and participants ' responses to questionnaires .
CONCLUSIONS	New strategies for early detection , monitoring , and management of delirium are needed in order to improve outcomes for both patients and families .
CONCLUSIONS	The present article exposes feasibility issues based on the first few months of the empirical phase of the study that may be useful to the scientific community interested in improving the care of patients with delirium .
CONCLUSIONS	Another potentially important contribution is in the exploration of cerebral oximetry , a promising measure as an objective indicator for early detection and continuous monitoring of delirium .
CONCLUSIONS	The proposed pilot study will build towards a larger trial with the potential to improve knowledge about delirium management and monitoring .
BACKGROUND	This pilot study was registered at Controlled Trials on March 27th 2013 and was assigned #ISRCTN 95736036 .

###24283283
OBJECTIVE	To compare the effect of 40 seconds versus 2 minutes brushing on saliva and dental biofilm fluid fluoride in children ages 4-5 years over 1 hour .
METHODS	This was a single-blind , cross-over , randomised , two-period clinical study in healthy children .
METHODS	Three days before the start of each treatment subjects received a thorough brushing and then refrained from all oral hygiene procedures .
METHODS	At treatment visits , after collecting baseline biofilm and saliva samples , staff brushed the occlusal surfaces of the subject 's posterior teeth with a pea-sized amount ( 0.25 g ) of NaF/silica toothpaste for the randomised time .
METHODS	Samples were taken at 5 minutes , 15 minutes , 30 minutes and 60 minutes after brushing and analysed for fluoride using a microanalytical methodology .
METHODS	There was a minimum 4-day washout period between treatments .
RESULTS	Log changes from baseline biofilm fluid and saliva fluoride were statistically significant ( P < 0.05 ) for both brushing times at all post-brushing time-points [ except 60 minutes saliva where P = 0.06 ( t-test ) ] .
RESULTS	Statistically significantly greater ln-AUC ( area under the curve ) was found for biofilm fluid and salivary fluoride after brushing for 2 minutes compared with brushing for 40 seconds over the 1-hour test period .
RESULTS	There was a statistically significantly higher concentration of fluoride in the log change from baseline saliva levels after 5 , 15 , 30 and 60 minutes for the 2-minute brushing time compared with 40 seconds brushing time .
RESULTS	There was no statistically significant difference in concentration of log change from baseline fluoride levels in biofilm fluid at each individual time-point ( 5 , 15 , 30 and 60 minutes ) for the 2-minute brushing time compared with the 40-second brushing time , but significant differences were observed for 15 , 30 and 60 minutes in favour of 2-minute brushing time when log biofilm fluid value was analysed .
CONCLUSIONS	The findings provide further evidence for the benefits of increased duration of brushing with respect to fluoride delivery .

###25469720
OBJECTIVE	Repeated blood donation produces iron deficiency .
OBJECTIVE	Changes in dietary iron intake do not prevent donation-induced iron deficiency .
OBJECTIVE	Prolonging the interdonation interval or using oral iron supplements can mitigate donation-induced iron deficiency .
OBJECTIVE	The most effective operational methods for reducing iron deficiency in donors are unknown .
METHODS	` Strategies To Reduce Iron Deficiency ' ( STRIDE ) was a two-year , randomized , placebo-controlled study in blood donors .
METHODS	692 donors were randomized into one of two educational groups or one of three interventional groups .
METHODS	Donors randomized to educational groups either received letters thanking them for donating , or , suggesting iron supplements or delayed donation if they had low ferritin .
METHODS	Donors randomized to interventional groups either received placebo , 19-mg or 38-mg iron pills .
RESULTS	Iron deficient erythropoiesis was present in 527 % of males and 746 % of females at enrolment .
RESULTS	Adverse events within 60 days of enrolment were primarily mild gastrointestinal symptoms ( 64 % ) .
RESULTS	The incidence of de-enrolment within 60 days was more common in the interventional groups than in the educational groups ( P = 0002 ) , but not more common in those receiving iron than placebo ( P = 068 ) .
CONCLUSIONS	The prevalence of iron deficient erythropoiesis in donors enrolled in the STRIDE study is comparable to previously described cohorts of regular blood donors .
CONCLUSIONS	De-enrolment within 60 days was higher for donors receiving tablets , although no more common in donors receiving iron than placebo .

###24837306
OBJECTIVE	We investigated whether screen-detected and apparently asymptomatic adults with endomysial antibodies ( EmA ) benefit from a gluten-free diet ( GFD ) .
METHODS	We performed a prospective trial of 3031 individuals at risk for celiac disease based on screens for EmA .
METHODS	Of 148 seropositive individuals , 40 fulfilled inclusion criteria and were assigned randomly to groups placed on a GFD or gluten-containing diets .
METHODS	We evaluated ratios of small-bowel mucosal villous height : crypt depth , serology and laboratory test results , gastrointestinal symptom scores , physiologic well-being , perception of health by a visual analog scale , bone mineral density , and body composition at baseline and after 1 year .
METHODS	Thereafter , the group on the gluten-containing diet started a GFD and was evaluated a third time ; subjects in the GFD group remained on this diet .
RESULTS	After 1 year on the GFD , the mean mucosal villous height : crypt depth values increased ( P < .001 ) , levels of celiac-associated antibodies decreased ( P < .003 ) , and gastrointestinal symptoms improved to a greater extent than in patients on gluten-containing diets ( P = .003 ) .
RESULTS	The GFD group also had reduced indigestion ( P = .006 ) , reflux ( P = .05 ) , and anxiety ( P = .025 ) , and better health , based on the visual analog scale ( P = .017 ) , than the gluten-containing diet group .
RESULTS	Only social function scores improved more in the gluten-containing diet group than in the GFD group ( P = .031 ) .
RESULTS	There were no differences between groups in laboratory test results , bone mineral density , or body composition .
RESULTS	Most measured parameters improved when patients in the gluten-containing diet group were placed on GFDs .
RESULTS	No subjects considered their experience to be negative and most expected to remain on GFDs .
CONCLUSIONS	GFDs benefit asymptomatic EmA-positive patients .
CONCLUSIONS	The results support active screening of patients at risk for celiac disease .
CONCLUSIONS	Clinicaltrials.gov no : NCT01116505 .

###26039521
BACKGROUND	Statin therapy reduces low-density lipoprotein ( LDL ) cholesterol levels and the risk of cardiovascular events , but whether the addition of ezetimibe , a nonstatin drug that reduces intestinal cholesterol absorption , can reduce the rate of cardiovascular events further is not known .
METHODS	We conducted a double-blind , randomized trial involving 18,144 patients who had been hospitalized for an acute coronary syndrome within the preceding 10 days and had LDL cholesterol levels of 50 to 100 mg per deciliter ( 1.3 to 2.6 mmol per liter ) if they were receiving lipid-lowering therapy or 50 to 125 mg per deciliter ( 1.3 to 3.2 mmol per liter ) if they were not receiving lipid-lowering therapy .
METHODS	The combination of simvastatin ( 40 mg ) and ezetimibe ( 10 mg ) ( simvastatin-ezetimibe ) was compared with simvastatin ( 40 mg ) and placebo ( simvastatin monotherapy ) .
METHODS	The primary end point was a composite of cardiovascular death , nonfatal myocardial infarction , unstable angina requiring rehospitalization , coronary revascularization ( 30 days after randomization ) , or nonfatal stroke .
METHODS	The median follow-up was 6 years .
RESULTS	The median time-weighted average LDL cholesterol level during the study was 53.7 mg per deciliter ( 1.4 mmol per liter ) in the simvastatin-ezetimibe group , as compared with 69.5 mg per deciliter ( 1.8 mmol per liter ) in the simvastatin-monotherapy group ( P < 0.001 ) .
RESULTS	The Kaplan-Meier event rate for the primary end point at 7 years was 32.7 % in the simvastatin-ezetimibe group , as compared with 34.7 % in the simvastatin-monotherapy group ( absolute risk difference , 2.0 percentage points ; hazard ratio , 0.936 ; 95 % confidence interval , 0.89 to 0.99 ; P = 0.016 ) .
RESULTS	Rates of prespecified muscle , gallbladder , and hepatic adverse effects and cancer were similar in the two groups .
CONCLUSIONS	When added to statin therapy , ezetimibe resulted in incremental lowering of LDL cholesterol levels and improved cardiovascular outcomes .
CONCLUSIONS	Moreover , lowering LDL cholesterol to levels below previous targets provided additional benefit .
CONCLUSIONS	( Funded by Merck ; IMPROVE-IT ClinicalTrials.gov number , NCT00202878 . )

###25181937
OBJECTIVE	Short-term physical activity ( PA ) has beneficial effects on symptom management and quality of life , however , longer-term adherence is likely needed for improved disease outcomes in breast cancer survivors ( BCS ) .
OBJECTIVE	This study examined the effects of a supervised group exercise program on motivational outcomes and PA among BCS at 5-year follow-up .
METHODS	The original study was a two-armed , randomized controlled trial comparing a 12-week supervised group exercise program to usual care among 203 BCS .
METHODS	BCS for this follow-up study were contacted at 60 months postintervention and asked to complete assessments of motivational outcomes from the Theory of Planned Behavior and PA behavior using the Scottish Physical Activity Questionnaire .
RESULTS	Overall , 87 participants provided 5-year follow-up data with no differences in participation by group .
RESULTS	Analyses of covariance ( ANCOVAs ) revealed that supervised exercise had a significant positive effect on descriptive norm at 5-year follow-up ( mean = +0.6 ; 95 % CI = +0.1 to +1.1 ; d = +0.48 ; p = 0.021 ) .
RESULTS	Small positive effects were also noted for perceived behavioral control ( d = +0.18 ) , instrumental attitude ( d = +0.26 ) , and injunctive norm ( d = +0.35 ) , although they were not statistically significant .
RESULTS	Moreover , BCS who were more active at 5-year follow-up also reported more favorable perceived behavioral control ( d = +0.16 ) , instrumental attitude ( d = +0.28 ) , injunctive norm ( d = +0.24 ) , and descriptive norm ( d = +0.31 ) , although these differences were not statistically significant .
CONCLUSIONS	This trial provides suggestive evidence that a supervised exercise program has positive effects on motivational outcomes even after 5 years .
CONCLUSIONS	Additional intervention strategies during follow-up may further improve long-term adherence and health outcomes in BCS .

###24807327
OBJECTIVE	To assess efficacy of the Foley catheter compared with the dinoprostone vaginal insert for beginning labor inductions at or near term .
METHODS	We performed a multicenter randomized controlled trial .
METHODS	We enrolled women at 36 weeks of gestation or greater with a singleton live fetus in cephalic presentation , intact membranes , an unfavorable cervix ( dilation less than 3 cm ; if 2 cm , less than 80 % effaced ) , and no contraindication to labor or either study agent .
METHODS	Women were allocated to either a cervical Foley catheter inflated to 30 mL or dinoprostone for up to 12 hours .
METHODS	Oxytocin was allowed only after study agent removal .
METHODS	The primary outcome was time from agent placement to delivery .
METHODS	Secondary outcomes included delivery by 24 hours , vaginal delivery by 24 hours , time to vaginal delivery , cesarean delivery rate , and rate of tachysystole .
METHODS	Analysis was by intent-to-treat .
RESULTS	We enrolled 376 patients , 185 allocated to Foley catheter and 191 to dinoprostone .
RESULTS	In the Foley catheter group , time to delivery was shorter ( median 21.6 compared with 26.6 hours ; P = .003 ) , more patients delivered within 24 hours ( 56 % compared with 40 % ; P = .003 ) , more delivered vaginally within 24 hours ( 44 % compared with 30 % ; P = .004 ) , and time to vaginal delivery was shorter ( median 20.1 compared with 24.3 hours ; P = .005 ) .
RESULTS	The cesarean delivery rates were 29 % compared with 39 % ( P = .07 ) .
RESULTS	Uterine tachysystole occurred in 0 % compared with 3 % ( P = .06 ) .
CONCLUSIONS	Starting labor inductions with a Foley catheter , compared with the dinoprostone vaginal insert , results in a shorter time to delivery and a higher proportion of women delivered and delivered vaginally within 24 hours .
CONCLUSIONS	Cesarean delivery rates were not statistically significantly different .
BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT01402050 .
BACKGROUND	LEVEL OF EVIEDENCE : I.

###25431484
OBJECTIVE	The aim of this study was to explore the clinical utility of the clinical disease activity index ( CDAI ) .
OBJECTIVE	We compared the disease control with protocolized treatment adjustment following a tight control strategy utilizing either the simplified disease activity index ( SDAI ) or the CDAI .
METHODS	In a prospective 12 month study , DMARD-naive RA patients were randomized to either a CDAI or SDAI arm and were treated with traditional DMARDs , increased on a monthly basis according to a predefined protocol to achieve low disease activity .
RESULTS	Of 102 patients ( 84 females , 96 Black Africans ) , the mean symptom duration was 3.0 years ( s.d. 3.8 ) and the mean 28-joint DAS ( DAS28 ) at baseline was 6.2 ( s.d. 1.2 ) .
RESULTS	By 12 months , the proportion of patients in the CDAI and SDAI groups achieving low disease activity ( 30 % and 32 % ) and remission ( 33 and 34 % ) were similar .
RESULTS	There were no significant differences in the mean DAS28 or its components or in HAQ Disability Index or health-related quality of life scores .
RESULTS	Baseline predictors of low disease activity at 12 months were shorter symptom duration ( P = 0.03 ) and lower HAQ-DI score ( P = 0.04 ) .
CONCLUSIONS	Given that the CDAI performed as well as the SDAI , and considering the cost savings and convenience because no acute phase reactant test is necessary , we suggest the CDAI may be an appropriate tool for monthly disease activity monitoring as part of a tight control strategy in developing countries .

###25071062
BACKGROUND	Levels of measles in England and Wales are at their highest for 18 years , and strategies targeting the different groups of parents who do not vaccinate their children continue to be needed .
BACKGROUND	Decision aids for decisions regarding childhood immunisation appear to be effective in achieving an increase in vaccine uptake but their cost effectiveness is unknown .
OBJECTIVE	To assess the cost effectiveness of a web-based decision aid to increase uptake of the MMR vaccine .
METHODS	Economic evaluation conducted alongside a cluster randomised controlled trial using urban GP practices in the north of England .
METHODS	Fifty GP practices in the north of England were randomised to one of three trial arms : decision aid , leaflet , usual practice .
METHODS	A total of 220 first-time parents ( child aged 3-12 months ) were recruited .
METHODS	Parents self-reported their contacts with the NHS and other previous/expected resource utilisation ; associated costs were calculated .
METHODS	Vaccine-uptake data were collected from GP practices .
METHODS	A cost-effectiveness analysis was undertaken and provided the incremental cost per first-vaccine uptake .
METHODS	Multiple imputation was used to account for missing data and findings were adjusted for baseline differences in parents ' levels of decisional conflict regarding MMR vaccination .
RESULTS	Of the 220 first-time parents recruited to the study , 179 completed the baseline and post-intervention questionnaires .
RESULTS	MMR uptake was highest for those receiving the decision aid ( 42 out of 42 , 100 % ) versus usual practice ( 61 out of 62 , 98 % ) and leaflet arm ( 69 out of 75 , 92 % ) , and was associated with lower cost ( -9.20 versus usual practice and -7.17 versus leaflet ) .
CONCLUSIONS	The decision aid has a high chance of being cost effective , regardless of the value placed on obtaining additional vaccinations .
CONCLUSIONS	It also appears to offer an efficient means of decision support for parents .

###24799484
OBJECTIVE	The optimal chemotherapy regimen administered concurrently with preoperative radiation therapy ( RT ) for patients with rectal cancer is unknown .
OBJECTIVE	National Surgical Adjuvant Breast and Bowel Project trial R-04 compared four chemotherapy regimens administered concomitantly with RT. .
METHODS	Patients with clinical stage II or III rectal cancer who were undergoing preoperative RT ( 45 Gy in 25 fractions over 5 weeks plus a boost of 5.4 Gy to 10.8 Gy in three to six daily fractions ) were randomly assigned to one of the following chemotherapy regimens : continuous intravenous infusional fluorouracil ( CVI FU ; 225 mg/m ( 2 ) , 5 days per week ) , with or without intravenous oxaliplatin ( 50 mg/m ( 2 ) once per week for 5 weeks ) or oral capecitabine ( 825 mg/m ( 2 ) twice per day , 5 days per week ) , with or without oxaliplatin ( 50 mg/m ( 2 ) once per week for 5 weeks ) .
METHODS	Before random assignment , the surgeon indicated whether the patient was eligible for sphincter-sparing surgery based on clinical staging .
METHODS	The surgical end points were complete pathologic response ( pCR ) , sphincter-sparing surgery , and surgical downstaging ( conversion to sphincter-sparing surgery ) .
RESULTS	From September 2004 to August 2010 , 1,608 patients were randomly assigned .
RESULTS	No significant differences in the rates of pCR , sphincter-sparing surgery , or surgical downstaging were identified between the CVI FU and capecitabine regimens or between the two regimens with or without oxaliplatin .
RESULTS	Patients treated with oxaliplatin experienced significantly more grade 3 or 4 diarrhea ( P < .001 ) .
CONCLUSIONS	Administering capecitabine with preoperative RT achieved similar rates of pCR , sphincter-sparing surgery , and surgical downstaging compared with CVI FU .
CONCLUSIONS	Adding oxaliplatin did not improve surgical outcomes but added significant toxicity .
CONCLUSIONS	The definitive analysis of local tumor control , disease-free survival , and overall survival will be performed when the protocol-specified number of events has occurred .

###25694068
BACKGROUND	Dietary flaxseed lowers cholesterol in healthy subjects with mild biomarkers of cardiovascular disease ( CVD ) .
OBJECTIVE	The aim was to investigate the effects of dietary flaxseed on plasma cholesterol in a patient population with clinically significant CVD and in those administered cholesterol-lowering medications ( CLMs ) , primarily statins .
METHODS	This double-blind , randomized , placebo-controlled trial examined the effects of a diet supplemented for 12 mo with foods that contained either 30 g of milled flaxseed [ milled flaxseed treatment ( FX ) group ; n = 58 ] or 30 g of whole wheat [ placebo ( PL ) group ; n = 52 ] in a patient population with peripheral artery disease ( PAD ) .
METHODS	Plasma lipids were measured at 0 , 1 , 6 , and 12 mo. .
RESULTS	Dietary flaxseed in PAD patients resulted in a 15 % reduction in circulating LDL cholesterol as early as 1 mo into the trial ( P = 0.05 ) .
RESULTS	The concentration in the FX group ( 2.1 0.10 mmol/L ) tended to be less than in the PL group ( 2.5 0.2 mmol/L ) at 6 mo ( P = 0.12 ) , but not at 12 mo ( P = 0.33 ) .
RESULTS	Total cholesterol also tended to be lower in the FX group than in the PL group at 1 mo ( 11 % , P = 0.05 ) and 6 mo ( 11 % , P = 0.07 ) , but not at 12 mo ( P = 0.24 ) .
RESULTS	In a subgroup of patients taking flaxseed and CLM ( n = 36 ) , LDL-cholesterol concentrations were lowered by 8.5 % 3.0 % compared with baseline after 12 mo. .
RESULTS	This differed from the PL + CLM subgroup ( n = 26 ) , which increased by 3.0 % 4.4 % ( P = 0.030 ) to a final concentration of 2.2 0.1 mmol/L .
CONCLUSIONS	Milled flaxseed lowers total and LDL cholesterol in patients with PAD and has additional LDL-cholesterol-lowering capabilities when used in conjunction with CLMs .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT00781950 .

###24227801
OBJECTIVE	To evaluate pazopanib eye drops in patients with subfoveal choroidal neovascularisation secondary to age-related macular degeneration .
METHODS	70 patients with minimally classic or occult subfoveal choroidal neovascularisation were randomly assigned to 5 mg/mL TID , 2 mg/mL TID , and 5 mg/mL QD pazopanib eye drops for 28 days in a multicentre , double-masked trial with an optional safety extension for up to 5 additional months .
METHODS	The primary outcomes were central retinal thickness ( CRT ) and best-corrected visual acuity ( BCVA ) at Day 29 .
RESULTS	No significant decrease from baseline in CRT was observed overall ; however , an exploratory analysis showed improvement in CRT ( mean decrease of 89 m ) in patients with the CFH TT genotype who received 5 mg/mL TID ( p = 0.01 , n = 5 ) .
RESULTS	Mean increases in BCVA were observed in the 5 mg/mL TID overall ( 4.32 letters ( p = 0.002 , n = 26 ) ) and in those that with CFH Y402H TT ( 6.96 letters ( p = 0.02 , n = 5 ) ) and CT ( 4.09 letters ( p = 0.05 , n = 9 ) ) genotypes .
RESULTS	No safety signals that precluded continued investigation were detected .
CONCLUSIONS	5 mg/mL pazopanib eye drops resulted in mean improvement in BCVA at Day 29 and improvements in vision .
CONCLUSIONS	However , improvement in macular oedema for age-related macular degeneration was found only in the subset of subjects with the CFH Y402H TT genotype , warranting further investigation .

###24873720
BACKGROUND	In preclinical studies , davunetide promoted microtubule stability and reduced tau phosphorylation .
BACKGROUND	Because progressive supranuclear palsy ( PSP ) is linked to tau pathology , davunetide could be a treatment for PSP .
BACKGROUND	We assessed the safety and efficacy of davunetide in patients with PSP .
METHODS	In a double-blind , parallel group , phase 2/3 trial , participants were randomly assigned with permuted blocks in a 1:1 ratio to davunetide ( 30 mg twice daily , intranasally ) or placebo for 52 weeks at 48 centres in Australia , Canada , France , Germany , the UK , and the USA .
METHODS	Participants met the modified Neuroprotection and Natural History in Parkinson Plus Syndrome study criteria for PSP .
METHODS	Primary endpoints were the change from baseline in PSP Rating Scale ( PSPRS ) and Schwab and England Activities of Daily Living ( SEADL ) scale at up to 52 weeks .
METHODS	All participants and study personnel were masked to treatment assignment .
METHODS	Analysis was by intention to treat .
METHODS	The trial is registered with Clinicaltrials.gov , number NCT01110720 .
RESULTS	313 participants were randomly assigned to davunetide ( n = 157 ) or to placebo ( n = 156 ) , and 241 ( 77 % ) completed the study ( 118 and 156 in the davunetide and placebo groups , respectively ) .
RESULTS	There were no differences in the davunetide and placebo groups in the baseline PSPRS and SEADL .
RESULTS	The davunetide and placebo groups did not differ in the change from baseline in PSPRS ( median 118 [ 95 % CI 105 to 130 ] vs 118 [ 105 to 130 ] , respectively , p = 041 ) or SEADL ( -020 [ -020 to -017 ] vs -020 [ -022 to -017 ] , respectively , p = 092 ) .
RESULTS	54 serious adverse events were reported in each of the treatment groups , including 11 deaths in the davunetide group and ten in the placebo group .
RESULTS	The frequency of nasal adverse events was greater in the davunetide group than in the placebo group ( epistaxis 18 [ 12 % ] of 156 vs 13 [ 8 % ] of 156 , rhinorrhoea 15 [ 10 % ] vs eight [ 5 % ] , and nasal discomfort 15 [ 10 % ] vs one [ < 1 % ] ) .
CONCLUSIONS	Davunetide is not an effective treatment for PSP .
CONCLUSIONS	Clinical trials of disease-modifying treatment are feasible in patients with PSP and should be pursued with other promising tau-directed treatments .
BACKGROUND	Allon Therapeutics .

###24603353
OBJECTIVE	To evaluate the efficacy and safety of intratympanic AM-101 in patients with persistent acute inner ear tinnitus after acute acoustic trauma , idiopathic sudden sensorineural hearing loss ( ISSNHL ) , or acute otitis media .
METHODS	Prospective , double-blind , randomized , placebo-controlled study with follow-up visits on Days 7 , 30 , and 90 .
METHODS	Twenty-eight European sites ( academic tertiary referral centers and private ENT practices ) .
METHODS	248 patients aged 16 to 65 years .
METHODS	Three intratympanic injections of AM-101 ( 0.27 or 0.81 mg/ml ) or placebo over 3 consecutive days .
METHODS	Efficacy was assessed by changes in minimum masking level ( MML ; primary end point ) , loudness match , tinnitus loudness , tinnitus annoyance , and sleep difficulties on a 0 to 100 numerical rating scale , THI-12 questionnaire , and patient global impression of change .
METHODS	Safety was evaluated using the frequency of clinically relevant hearing deterioration and adverse events .
RESULTS	The study overall failed to demonstrate a treatment benefit based on the change in MML .
RESULTS	However , AM-101 0.81 mg/ml showed statistically significantly better improvement for tinnitus loudness , annoyance , sleep difficulties , and tinnitus impact in patients with tinnitus after noise trauma or otitis media .
RESULTS	The subgroup of ISSNHL-related tinnitus patients did not show conclusive results .
RESULTS	The study drug and I.T. injections were well tolerated .
CONCLUSIONS	The study established proof of concept for AM-101 in the treatment of tinnitus arising from cochlear glutamate excitotoxicity .
CONCLUSIONS	Patient-reported outcomes seem to be more relevant and reliable efficacy measures for assessing treatment-related changes in tinnitus than psychoacoustic tests .

###24713285
OBJECTIVE	To explore the effect of vitamin A ( VA ) combined iron supplements on iron metabolic homeostasis for preschoolers .
METHODS	About 445 preschoolers with aged 3-6 years old from eight kindergartens in Pixian county , Chengdu were recruited into this trial from March to September , 2011 .
METHODS	All subjects met the inclusion criteria were randomly divided into four groups using random number table : sole VA supplementation group ( VA group , a single oral dose of VA at about 200 000 units ) , sole iron supplementation group ( FE group , daily oral supplementation with the element iron 1-2 mgkg ( -1 ) d ( -1 ) for five days a week , lasting for 6 months ) , the combined supplementation of VA and iron group ( VF group ) and control group ( CO group , no VA and iron supplementation ) .
METHODS	The concentration of serum VA , serum ferritin ( SF ) , serum transferring receptor ( sTfR ) , C-reactive protein ( CRP ) and hemoglobin ( Hb ) were measured from 3 ml vein blood .
METHODS	The sTfR-SF index ( TFR-F index ) and total body iron content ( TBIC ) before and after intervention were calculated .
METHODS	The differences of these indexes between groups before and after intervention were analyzed .
RESULTS	The level of sTfR before intervention in VA group ( ( 1.78 0.17 ) mg/L ) was significantly higher than that of after intervention ( ( 1.18 0.11 ) mg/L ) ( t = 28.88 , P < 0.01 ) .
RESULTS	The levels of TFR-F index and TBIC in FE and VF groups before intervention ( ( 1.59 0.37 ) , ( 1.63 0.40 ) and ( 9.04 2.71 ) , ( 9.26 2.33 ) mg/kg , respectively ) were all lower than those of after intervention ( TFR-F index : ( 1.84 0.51 ) , ( 1.87 0.45 ) and TBIC : ( 12.42 3.49 ) , ( 13.01 2.98 ) mg/kg ) ( t values were 3.93 , 3.78 , 7.57 and 9.41 , respectively , all P values were < 0.01 ) .
RESULTS	The incidence of iron deficiency in VA , FE , and VF groups before intervention were 26 % ( 25/95 ) , 31 % ( 30/98 ) and 31 % ( 28/90 ) and were 41 % ( 39/95 ) , 10 % ( 10/98 ) and 18 % ( 16/90 ) for after intervention , respectively .
RESULTS	The difference of this index in VA , FE and VF groups were significant ( ( 2 ) values were 4.59 , 12.50 and 4.31 , respectively , all the P values were < 0.05 ) .
CONCLUSIONS	Combined VA and iron was as effective as VA alone or iron alone in decreasing the iron deficiency , the impact of VA intervention on iron metabolic homeostasis was mainly manifested in iron usage and mobilization , but showed no effect on total body iron content .

###25040850
OBJECTIVE	To examine the effects of two factors on the transmission of clinical information at nursing handover .
OBJECTIVE	These factors were : ( i ) an affective statement expressing concern about the information ; and ( ii ) verbal reference to a written summary of the information .
BACKGROUND	Quality of communication at patient handover is inconsistent , compromising patient safety .
BACKGROUND	Little is known about the nuances of communication that lead to effective handovers .
BACKGROUND	Furthermore , effective information transmission during handovers is seldom evaluated using experimental research designs .
METHODS	A randomized , single-blind , controlled experiment .
METHODS	Postanaesthesia care unit or surgical ward nurses and final-year nursing students were randomly assigned to watch one of four versions of a video-recorded handover .
METHODS	In each version , one piece of information was presented as either a simple statement ( control ) , with an affective qualifier , with a written summary of the information , or with both an affective qualifier and a written summary .
METHODS	Primary outcome was assessed by questionnaire following a task directing attention away from the handover .
METHODS	Data were collected July-October , 2013 and analysed using 22 anova .
RESULTS	A total of 157 nurses participated .
RESULTS	Successful transmission of the clinical information did not significantly differ across the experimental conditions .
RESULTS	Subgroup analysis revealed significantly higher transmission success among more experienced nurses when the affective statement was present compared to when it was absent ( Kruskal-Wallis P = 0002 ) .
CONCLUSIONS	Expressing concern about information or directing attention to written notes may not improve information transfer at handover .
CONCLUSIONS	However , affective qualifiers may have differential receiver-specific influences on information retention .

###24805282
BACKGROUND	Ultrasound guidance is still a young method in regional anesthesia when compared to nerve stimulation and only a few studies exist comparing these two techniques in an axillary multiple injection approach .
OBJECTIVE	This prospective , randomized , observer-blinded study compared an ultrasound-guided ( SONO ) quadruple injection axillary block ( out of plane , perineural ) with a nerve stimulation-guided ( STIM ) triple injection axillary block for upper limb surgery .
METHODS	A total of 60 patients were randomized to either the SONO ( n = 30 ) or STIM ( n = 30 ) group .
METHODS	For the block 40-50ml mepivacaine 1.5 % ( plexus ) and 5-10ml mepivacaine 0.5 % ( subcutaneous in the medial skin of the arm ) was used .
METHODS	Anesthesia time was recorded as the primary end point .
METHODS	After evaluation of block-related pain using a visual analog scale ( VAS ) a blinded observer tested sensory and motor function of the median nerve ( MED ) , ulnar nerve ( ULN ) , radial nerve ( RAD ) , musculocutaneous nerve of the upper limb ( MUC ) and medial cutaneous nerve of the forearm ( CAM ) at defined times .
METHODS	The main outcome variable was onset time ( defined loss of sensory/motor function ) .
RESULTS	No differences were observed between the groups in terms of onset time ( single nerves 10-20min , plexus 20-25min ) and success rate ( SONO 90 % , STIM 89 % ) .
RESULTS	Patient satisfaction as measured by block-related pain score ( VAS 2cm ) , complications ( vascular puncture SONO 7 % , STIM 11 % ; paresthesia SONO 21 % , STIM 22 % ) and patient acceptance ( SONO 92 % , STIM 91 % ) showed no differences .
RESULTS	Performance time was shorter in the SONO group ( 6.681.72 min vs. 8.052.58 , p = 0.02 ) .
CONCLUSIONS	Nerve stimulation-guided axillary plexus blocks performed by trained anesthesiologists may result in similar onset times and success rates compared to ultrasound-guided blocks .

###25171742
BACKGROUND	Multidisciplinary , age-related , structured , group educational programmes for children with atopic dermatitis ( AD ) and their parents have shown positive long-term outcomes with respect to quality of life and coping behaviour of the participants .
BACKGROUND	We aimed to identify predictors of favourable long-term outcome of an education measure for parents of children with AD aged 3months to 7years in the framework of The German Atopic Dermatitis Intervention Study ( GADIS ) .
METHODS	In an exploratory approach , the data of 274 child-parent pairs were analysed with respect to the influence of various somatic and psychological variables as possible predictors of treatment success .
METHODS	Changes in parents ' QoL , SCORAD ( Scoring Atopic Dermatitis ) , topical corticosteroid use and parents ' knowledge about AD between baseline and 12-months ' follow-up were chosen as measures of long-term treatment success ( outcome ) .
RESULTS	Psychological rather than somatic parameters were identified as predictors of treatment success .
RESULTS	Parents who had negative treatment experiences in the past and possessed only poor coping abilities with regard to scratch control benefitted the most from the training programme .
RESULTS	The outcome of the education measure was independent of parents ' schooling , vocational level and income .
CONCLUSIONS	Parents of children with AD who lack adequate coping abilities should be particularly encouraged to take part in such an education programme .

###24840774
BACKGROUND	Surgical site infections ( SSI ) after vascular surgery are related to substantial morbidity .
BACKGROUND	Restriction of bacterial access to the site of surgery with a cyanoacrylate sealant is a new concept .
BACKGROUND	We performed a randomized clinical trial to assess the effect of the sealing of skin with a cyanoacrylate preparation at the site of surgery on the incidence of SSI after arterial reconstruction .
METHODS	Patients scheduled for vascular reconstruction in or distal to the groin were randomized into a treatment and a control group .
METHODS	Standard measures for preventing contamination of the surgical field were taken in the control group , whereas cyanoacrylate was used as a skin sealant at the surgical site in the patients in the treatment group .
METHODS	We hypothesized that the incidence of SSI with the use of cyanoacrylate would be two-thirds ( 67 % ) lower than that with standard preparation of the surgical site , and performed an interim analysis of 50 patients to assess this .
RESULTS	Risk factors among the 50 patients in the study included smoking ( 28 % ) , hypertension ( 77 % ) , diabetes mellitus ( 36 % ) , and hypercholesterolemia ( 74 % ) .
RESULTS	Indications for surgery were invalidating claudication ( Fontaine IIb ) , pain at rest , or tissue necrosis .
RESULTS	The overall incidence of SSI was 3/47 ( 6 % ) , without differences between groups ; 9 % SSIs in the control group versus 4 % SSIs in the intervention group .
CONCLUSIONS	We could not confirm a reduction in the incidence of SSI after inguinal vascular surgery with the use of a cyanoacrylate skin sealant as compared with conventional means for preparing the surgical site .

###25303988
BACKGROUND	Thromboelastometric evaluation of coagulation might be useful for prediction and management of bleeding after paediatric cardiac surgery .
BACKGROUND	We tested the hypothesis that the use of a thromboelastometry-guided algorithm for blood product management reduces blood loss and transfusion requirements .
METHODS	We studied 78 patients undergoing paediatric cardiac surgery with cardiopulmonary bypass ( CPB ) for the initial 12 h after operation .
METHODS	Stepwise multiple linear regression was used to develop an algorithm to guide blood product transfusions .
METHODS	Thereafter , we randomly assigned 100 patients to conventional or algorithm-guided blood product management , and assessed bleeding and red cell transfusion requirements .
RESULTS	CPB time , post-bypass rotational thromboelastometry ( ROTEM ( ) ) EXTEM amplitude at 10 min ( A10 ) , and FIBTEM-A10 were independently associated with chest tube drainage volume during the initial 12 h after operation .
RESULTS	Discriminative analysis determined cut-off values of 30 mm for EXTEM-A10 and 5 mm for FIBTEM-A10 , and estimated optimal intraoperative fresh-frozen plasma and platelet concentrate transfusion volumes .
RESULTS	Thromboelastometry-guided post-bypass blood product management significantly reduced postoperative bleeding ( 9 vs 16 ml kg ( -1 ) , P < 0.001 ) and packed red cell transfusion requirement ( 11 vs 23 ml kg ( -1 ) , P = 0.005 ) at 12 h after surgery , and duration of critical care stay ( 60 vs 71 h , P = 0.014 ) .
CONCLUSIONS	Rotational thromboelastometry-guided early haemostatic intervention by rapid intraoperative correction of EXTEM-A10 and FIBTEM-A10 reduced blood loss and red cell transfusion requirements after CPB , and reduced critical care duration in paediatric cardiac surgical patients .
BACKGROUND	UMIN Clinical Trials Registry UMIN000006832 ( December 4 , 2011 ) .

###25453536
OBJECTIVE	The goal of this study was to assess the safety and tolerability of omecamtiv mecarbil treatment during symptom-limited exercise in patients with ischemic cardiomyopathy and angina .
OBJECTIVE	These patients may have increased vulnerability to prolongation of the systolic ejection time .
BACKGROUND	Omecamtiv mecarbil is a selective cardiac myosin activator that augments cardiac contractility in patients with systolic heart failure through a dose-dependent increase in systolic ejection time .
METHODS	In this double-blind , placebo-controlled study , patients with chronic heart failure were randomized 2:1 to receive omecamtiv mecarbil or placebo in 2 sequential cohorts of escalating doses designed to achieve plasma concentrations previously shown to increase systolic function .
METHODS	Patients underwent 2 symptom-limited exercise treadmill tests ( ETTs ) at baseline ( ETT1 and ETT2 ) and again before the end of a 20-h infusion of omecamtiv mecarbil ( ETT3 ) .
RESULTS	The primary pre-defined safety endpoint ( i.e. , the proportion of patients who stopped ETT3 because of angina at a stage earlier than baseline ) was observed in 1 patient receiving placebo and none receiving omecamtiv mecarbil .
RESULTS	No dose-dependent differences emerged in the proportion of patients stopping ETT3 for any reason or in the pattern of adverse events .
CONCLUSIONS	Doses of omecamtiv mecarbil producing plasma concentrations previously shown to increase systolic function were well tolerated during exercise in these study patients with ischemic cardiomyopathy and angina .
CONCLUSIONS	There was no indication that treatment increased the likelihood of myocardial ischemia in this high-risk population .
CONCLUSIONS	( Pharmacokinetics [ PK ] and Tolerability of Intravenous [ IV ] and Oral CK-1827452 in Patients With Ischemic Cardiomyopathy and Angina ; NCT00682565 ) .

###24595613
BACKGROUND	There is currently a trend toward minimally invasive total knee arthroplasty ( TKA ) to decrease the morbidity related to the standard approach .
BACKGROUND	The aim of our study was to clarify whether the mini-subvastus surgical had an advantage over the standard in term of pain level , blood loss , and postoperative recovery , whether the mini-subvastus surgical was prone to radiographic malalignment , prolonged operative time , and increased complications .
METHODS	In a prospective randomized study , we compared the clinical and radiological results of primary TKA using a mini-subvastus approach or a standard approach in 68 patients .
METHODS	The mini-subvastus approach was used on 35 patients ( group I ) and the standard approach on 33 patients ( group II ) .
RESULTS	The mean follow-up was 28 months ( range 24-36 months ) .
RESULTS	Patients in group I had less blood loss and better visual analogue scale score at 1 day postoperatively .
RESULTS	They achieved active straight leg raise earlier and underwent less lateral retinacular releases .
RESULTS	The mean Knee Society function score , Oxford knee score , and range of movement were significantly better in group I up to 9 months after surgery ( all , p < 0.05 ) .
RESULTS	However , there were no significant differences in these parameters between the groups at final follow-up .
RESULTS	Reduced access and visibility in group I prolonged tourniquet time by an average of 22 min and resulted in five technical errors on radiographic evaluation .
CONCLUSIONS	Patients can receive marked but temporary benefits from the mini-subvastus technique , with a definite cost : that of component malposition and prolongation of operative time .

###24296869
OBJECTIVE	Ivabradine ( IVA ) , a selective If current inhibitor decreasing the heart rate ( HR ) in patients with sinus rhythm , has been added to the most recent European Guidelines on heart failure .
OBJECTIVE	This selective treatment reduces HR exclusively while fully preserving myocardial contractility and relaxation , atrioventricular conduction , and ventricular repolarization , as well as blood pressure .
OBJECTIVE	The aim of this study was to evaluate the improvement of quality of life ( QOL ) in patients with chronic heart failure ( CHF ) treated with IVA versus two - blockers ( bisoprolol and carvedilol ) .
METHODS	We evaluated if a 1-month treatment with IVA ( 5 mg b.i.d. ) or - blockers ( carvedilol 6.25 mg b.i.d. or bisoprolol 1.25 mg b.i.d. ) improves the QOL ( assessed by SF-36 questionnaire ) in patients with CHF with reduced left ventricular ejection fraction ( < 50 % ) .
METHODS	SF-36 was tested in 221 CHF patients ( mean age 64 6 years ) randomized into two groups ( IVA group - 110 patients ; - blockers group - 111 patients ) .
METHODS	Data of QOL questionnaire and HR were collected by an interview during a clinical visit both at prescription time ( basal ) and after 1 month of therapy with IVA or - blockers .
METHODS	QOL life and HR results after 1-month of therapy ( T1 ) with IVA were compared with basal values ( T0 ) .
RESULTS	The IVA versus - blockers treatment was associated with a significant improvement of physical functioning ( p < 0.001 vs. p < 0.01 ) , physical role functioning ( p < 0.001 vs. p < 0.01 ) , emotional role functioning ( p < 0.01 vs. p < 0.85 ) , and mental health scales ( p < 0.001 vs. p < 0.01 ) .
RESULTS	HR in the IVA group was significantly lower compared to the group of patients treated with - blockers ( 63 vs. 67 bpm ; p < 0.001 ) .
CONCLUSIONS	IVA treatment significantly improves the QOL in patients with CHF without any deleterious impact on hemodynamics , and may be beneficial in these patients without other adverse effects associated with - blockers .

###25318999
BACKGROUND	Lyme borreliosis , a potentially severe tick-borne infection caused by Borrelia burgdorferi , can cause multi-system inflammatory disease .
BACKGROUND	The incidence has been increasing , as has the number of patients with persistent symptoms attributed to Borrelia .
BACKGROUND	These symptoms , also referred to as post-Lyme disease syndrome , may follow an erythema migrans or other Lyme manifestations , and include pain , fatigue , and cognitive disturbances .
BACKGROUND	The optimal duration of treatment for these symptoms is a subject of controversy .
BACKGROUND	The PLEASE study is designed to determine whether prolonged antibiotic treatment leads to better patient outcome than standard treatment .
METHODS	The PLEASE study is a double-blind , randomized , placebo-controlled trial .
METHODS	Based on power analysis and compensating for possible loss to follow-up , a minimum of 255 patients with borreliosis-attributed persistent symptoms are included .
METHODS	These symptoms are either ( a ) temporally related to an erythema migrans or otherwise proven symptomatic borreliosis , or ( b ) accompanied by a positive B. burgdorferi IgG or IgM immunoblot .
METHODS	All patients receive open-label ceftriaxone for two weeks .
METHODS	Patients are then randomized ( ratio 1:1:1 ) to blinded oral follow-up treatment for 12 weeks with ( I ) doxycycline , ( II ) clarithromycin combined with hydroxychloroquine , or ( III ) placebo .
METHODS	The primary outcome is the physical component summary score ( PCS ) of the RAND-36 Health Status Inventory ( RAND SF-36 ) at week 14 .
METHODS	Secondary outcomes include physical and mental aspects of health-related quality of life ( assessed by the subscales of the RAND SF-36 ) , fatigue , neuropsychological evaluation , physical activity , and cost-effectiveness .
CONCLUSIONS	This article describes the background and design issues of the PLEASE study protocol .
CONCLUSIONS	The results of this study may provide evidence for prescribing or withholding prolonged antibiotic treatment .
BACKGROUND	ClinicalTrials.gov : NCT01207739 , Netherlands Trial Register : NTR2469 .

###24657428
BACKGROUND	Contact force ( CF ) monitoring could be useful in accomplishing circumferential pulmonary vein ( PV ) isolation ( CPVI ) for atrial fibrillation ( AF ) .
OBJECTIVE	The purpose of this study was to compare procedure parameters and outcomes between CF-guided and non-guided CPVI .
METHODS	Thirty-eight consecutive AF patients ( mean age 60 11 years , 28 paroxysmal AF ) undergoing CPVI were randomized to non-CF-guided ( n = 19 ) and CF-guided ( n = 19 ) groups .
METHODS	CPVI was performed with the ThermoCool SmartTouch catheter in both groups .
METHODS	The end-point was bidirectional block between the left atrium ( LA ) and PV .
METHODS	In the CF group , CF was kept between 10 and 20 g during CPVI , whereas in the non-CF group , all CF information was blanked .
METHODS	Radiofrequency energy at 30 W in the anterior and 25 W in the posterior LA wall was applied for 20-25 seconds at each point .
RESULTS	CPVI was successfully accomplished without any major complications in both groups .
RESULTS	Mean CF in the non-CF and CF groups were 5.9 4.5 g and 11.1 4.3 g , respectively , for left-side CPVI , and 9.8 6.6 g and 12.1 4.8 g , respectively , for right-side CPVI ( both P < .001 ) .
RESULTS	The procedure and fluoroscopy times for CPVI in the non-CF and CF groups were 96 39 minutes and 59 16 minutes , respectively ( P < .001 ) , and 22 63 seconds and 9 20 seconds ( P = NS ) , respectively .
RESULTS	Total number of residual conduction gaps was 6.3 3.0 in the non-CF group and 2.8 1.9 in the CF group ( P < .001 ) .
RESULTS	During 6-month follow-up , 84.2 % of patients in the non-CF group and 94.7 % in the CF group were free from any atrial tachyarrhythmias ( P = .34 ) .
CONCLUSIONS	CF-guided CPVI is effective in reducing procedure time and additional touch-up ablation and may improve long-term outcome .

###24952712
OBJECTIVE	To measure neurodevelopment at 3 years of age in children with single right-ventricle anomalies and to assess its relationship to Norwood shunt type , neurodevelopment at 14 months of age , and patient and medical factors .
METHODS	All subjects in the Single Ventricle Reconstruction Trial who were alive without cardiac transplant were eligible for inclusion .
METHODS	The Ages and Stages Questionnaire ( ASQ , n = 203 ) and other measures of behavior and quality of life were completed at age 3 years .
METHODS	Medical history , including measures of growth , feeding , and complications , was assessed through annual review of the records and phone interviews .
METHODS	The Bayley Scales of Infant Development , Second Edition ( BSID-II ) scores from age 14 months were also evaluated as predictors .
RESULTS	Scores on each ASQ domain were significantly lower than normal ( P < .001 ) .
RESULTS	ASQ domain scores at 3 years of age varied nonlinearly with 14-month BSID-II .
RESULTS	More complications , abnormal growth , and evidence of feeding , vision , or hearing problems were independently associated with lower ASQ scores , although models explained < 30 % of variation .
RESULTS	Type of shunt was not associated with any ASQ domain score or with behavior or quality-of-life measures .
CONCLUSIONS	Children with single right-ventricle anomalies have impaired neurodevelopment at 3 years of age .
CONCLUSIONS	Lower ASQ scores are associated with medical morbidity , and lower BSID-II scores but not with shunt type .
CONCLUSIONS	Because only a modest percentage of variation in 3-year neurodevelopmental outcome could be predicted from early measures , however , all children with single right-ventricle anomalies should be followed longitudinally to improve recognition of delays .

###24709166
BACKGROUND	Community-acquired pneumonia ( CAP ) is a common infectious disease throughout the world and the incidence continues to grow as the population ages .
BACKGROUND	Aspiration is an important pathogenic mechanism for pneumonia in the elderly and the management of patients with community-acquired pneumonia with aspiration factors is a major medical problem .
BACKGROUND	Our study aimed to assess whether moxifloxacin in comparison to levofloxacin plus metronidazole are effective and safe in the treatment of community-acquired pneumonia with aspiration factors .
METHODS	In this prospective , multicenter , open-label , randomized controlled trial , 77 patients with mild-to-moderate community-acquired pneumonia with aspiration factors were enrolled and randomly assigned to receive moxifloxacin or levofloxacin plus metronidazole .
METHODS	The primary efficacy variables were clinical outcomes in evaluable patients at a follow-up visit 7 to 14 days after the end of therapy .
RESULTS	Seven days after the end of therapy a clinical cure was achieved for 76.7 % ( 23 of 37 ) of efficacy-evaluable patients in the moxifloxacin group and 51.7 % ( 15 of 40 ) of patients in the levofloxacin plus metronidazole group .
RESULTS	There was a significant difference between the two groups ( ( 2 ) = 4.002 , P < 0.05 ) .
RESULTS	Bacteriological success rates were similar in the moxifloxacin group ( 93.3 % ) and levofloxacin plus metronidazole group ( 96.4 % ) , there was no significant difference between the two groups ( P > 0.05 ) .
RESULTS	The overall adverse event rate was 10.8 % ( 4/37 ) in the moxifloxacin group versus 17.5 % ( 7/40 ) in the levofloxacin plus metronidazole group , there was no significant difference between the two groups ( P > 0.05 ) .
RESULTS	No serious adverse events were observed .
CONCLUSIONS	Moxifloxacin is effective and safe for treatment of community-acquired pneumonia with aspiration factors .
CONCLUSIONS	And the regimen of moxifloxacin monotherapy is more convenient compared with levofloxacin plus metronidazole .

###24266524
OBJECTIVE	Premature infants respond more intensively to pain compared with term infants .
OBJECTIVE	Facilitated tucking position as a non-pharmacological method of pain in infants has been suggested ; however , its effect on acute procedural pain such as endotracheal suctioning remains to be studied .
OBJECTIVE	This study examined the effect of facilitated tucking position during suctioning on physiological responses and coping with stress in premature infants .
METHODS	This was a randomized controlled crossover study .
METHODS	Thirty-four premature infants received an order of either suctioning with intervention - suctioning without intervention , or suctioning without intervention - suctioning with intervention .
METHODS	Neonatal Infant Pain Scale ( NIPS ) was used to collect the data .
RESULTS	No statistical significant difference was seen between intervention and non-intervention cases in terms of the average time duration to reach the pain score to one or zero , and also , in the average of changes in oxygen saturation .
RESULTS	However , changes in heart rate were less in intervention cases .
CONCLUSIONS	The effect of facilitated tucking position on coping with stress was not found in this study .
CONCLUSIONS	This non-pharmacological strategy can be suggested because of its effect on reducing changes in heart rate during painful procedure .
CONCLUSIONS	It is suggested to replicate the study with larger number of samples .

###25745875
OBJECTIVE	To evaluate intravitreal aflibercept 2 mg in patients with myopic choroidal neovascularization ( CNV ) .
METHODS	An international , phase III , multicenter , randomized , double-masked , sham-controlled study .
METHODS	Patients aged 18 years with high myopia ( -6.0 diopters or axial length of 26.5 mm ) , active myopic CNV , and best-corrected visual acuity ( BCVA ) of 73-35 Early Treatment Diabetic Retinopathy Study letters in the study eye were included .
METHODS	Patients were randomized 3:1 to intravitreal aflibercept or sham .
METHODS	In the intravitreal aflibercept arm , patients received 1 injection at baseline .
METHODS	Additional injections were performed in case of CNV persistence or recurrence at monthly visits through week 44 .
METHODS	In the sham arm , patients received sham injections through week 20 .
METHODS	At week 24 , after assessment of the primary efficacy end point , sham patients received a mandatory intravitreal aflibercept injection followed by intravitreal aflibercept ( if disease persisted/recurred ) or sham injection every 4 weeks .
METHODS	Mean change in BCVA from baseline to week 24 .
RESULTS	A total of 122 patients were randomized to intravitreal aflibercept ( n = 91 ) or sham ( n = 31 ) .
RESULTS	Baseline demographics were similar across groups .
RESULTS	At week 24 , patients in the intravitreal aflibercept and sham groups gained 12.1 and lost 2 letters , respectively ( P < 0.0001 ) .
RESULTS	By week 48 , patients in the intravitreal aflibercept and sham/intravitreal aflibercept groups gained 13.5 and 3.9 letters .
RESULTS	Patients in the intravitreal aflibercept group received 2 injections ( median ) in the first study quarter ( week 0-8 ) .
RESULTS	Median number of injections in quarters 2 to 4 was 0 .
RESULTS	Patients in the `` sham/intravitreal aflibercept '' group received 2 and 1 ( median ) intravitreal aflibercept injections in quarters 3 and 4 .
RESULTS	Central retinal thickness improved in parallel with visual gains .
RESULTS	Incidence of ocular adverse events was similar in both groups through week 48 ( 37.4 % vs. 38.7 ) ; most were assessed by investigators as mild .
RESULTS	No deaths occurred .
CONCLUSIONS	Intravitreal aflibercept 2 mg was effective for treatment of myopic CNV with clinically important visual and anatomic benefits achieved with a limited number of injections given in the first 8 weeks of treatment .
CONCLUSIONS	No new safety concerns occurred with treatment .
CONCLUSIONS	Intravitreal aflibercept should be considered as a treatment option for myopic CNV .

###24243931
OBJECTIVE	The aim of this study was to compare the pain perception and side effects during and after endovenous laser ablation with a 1470 nm diode laser using cold or room temperature tumescence anesthesia .
METHODS	One hundred and one patients were randomly assigned in two groups .
METHODS	Group A received room temperature ( +24 ) and Group B received cold ( +4 ) tumescence fluid , which was used for local anesthesia in the track of great saphenous vein .
METHODS	A visual analog score was recorded immediately after the procedure .
METHODS	Patients were asked to register pain scores and the amount of pain medication consumed during the week .
RESULTS	There was no significant difference concerning gender , age , Clinical Etiological Anatomical Pathological Classification , body mass index , or diameter of the treated vein .
RESULTS	In Group A , the mean linear endovenous energy density was 59.5 J/cm and in Group B , it was 60.4 J/cm .
RESULTS	The average visual analog score after the endovenous laser ablation procedure in Group A was 5 and in Group B was 2 .
RESULTS	Third day after the procedure , the average visual analog score in Group A was 3 and in Group B was 1 .
RESULTS	Patients in Group B needed significantly less analgesics compared with patients in Group A ( p < 0.05 ) .
RESULTS	The most frequent side effects in both groups were ecchymosis , induration , and minor paraesthesia , all of which were more common in Group A ( p < 0.001 ) .
CONCLUSIONS	To date , most published endovenous laser ablation series describe the use of room temperature tumescence fluid infiltration of the perivenous stroma for tumescent analgesia and protection against thermal injury to the nearby structures .
CONCLUSIONS	We describe an alternative technique using cold tumescence fluid infiltration , which is equally effective as , but safer than , room temperature tumescence fluid infiltration , and which yields better visual analog scores .

###25269655
BACKGROUND	Although several studies have compared a conventional transtibial technique with an anteromedial ( AM ) portal technique for single-bundle ( SB ) anterior cruciate ligament ( ACL ) reconstruction , no study to date has investigated whether the modified transtibial technique results in the femoral tunnel being in a similar anatomic position and produces similar clinical outcomes with those of the AM portal technique .
OBJECTIVE	To compare the clinical outcomes and femoral tunnel position of SB ACL reconstruction using a modified transtibial technique ( creating a femoral tunnel with varus and internal rotation of the tibia as well as modification of the tibial tunnel orientation ) with those of SB ACL reconstruction using an AM portal technique .
METHODS	Randomized controlled trial ; Level of evidence , 1 .
METHODS	A total of 40 patients ( 40 knees ) who underwent arthroscopic SB ACL reconstruction were included in this study .
METHODS	Patients were randomized using a computer-generated sequence into 2 groups : 20 patients by the modified transtibial technique ( group 1 ) and 20 patients by the AM portal technique ( group 2 ) .
METHODS	Clinical evaluations included the 2000 International Knee Documentation Committee ( IKDC ) subjective knee score , Lysholm knee score , Tegner activity scale , Lachman test , pivot-shift test , 2000 IKDC knee examination , and KT-1000 arthrometer measurement .
METHODS	Three-dimensional computed tomography scans were analyzed according to the quadrant method , and the obliquity of the femoral tunnels in the coronal and sagittal planes and the size of the tunnel orifice were measured .
RESULTS	All clinical parameters improved significantly after SB ACL reconstruction , with no between-group differences .
RESULTS	The mean distance of the femoral tunnel center location from the posterior condylar surface ( 0.8 % difference ; P = .167 ) and from the Blumensaat line ( 2.1 % difference ; P = .067 ) was similar in groups 1 and 2 .
RESULTS	The mean coronal obliquity of the femoral tunnel was significantly lower in group 1 than in group 2 ( 42.5 6.1 vs 49.3 7.2 , respectively ; P = .001 ) , but the mean sagittal obliquity was similar between the 2 groups ( 41.9 6.1 vs 43.3 5.4 , respectively ; P = .303 ) .
RESULTS	The mean area of the tunnel orifice was significantly greater in group 1 than in group 2 ( 11.6 1.4 9.2 1.6 mm vs 10.3 1.1 9.1 1.4 mm , respectively ; P = .013 ) .
CONCLUSIONS	The modified transtibial technique for SB ACL reconstruction showed good clinical results and anatomic placement of the femoral tunnel , similar with those of the AM portal technique .

###24979519
BACKGROUND	Vernal keratoconjunctivitis ( VKC ) is a chronic , bilateral inflammation of the conjunctiva that mostly affects children and young adult males .
BACKGROUND	Management of VKC is primarily aimed at reducing symptoms and preventing serious vision threatening sequelae .
OBJECTIVE	To assess the efficacy of topical cyclosporine A ( CsA ) 0.05 % on the signs and symtomps in the management of VKC .
METHODS	This is a placebo-controlled , randomized prospective study .
METHODS	Sixty-two patients with VKC were included in this study .
METHODS	Patients were randomly assigned ( 1 : 1 ) to treatment with topical 0.05 % CsA eyedrops or a placebo ( artificial tears ) for a period of 4 weeks , 4 times daily .
METHODS	Ocular signs and symptoms were in all patients scored at entry and at the end of 4 weeks .
RESULTS	When pre-treatment mean signs and symptoms scores were compared in both groups , there was no significant difference ( p > 0.05 ) .
RESULTS	However , mean post-treatment scores as regards signs and symptoms were found to be lower in cyclosporine group than those in placebo group ( p < 0.001 ) .
RESULTS	No side effects of the treatment with CsA 0.05 % eyedrops were observed .
CONCLUSIONS	It was found that topical CsA 0.05 % eyedrops were safe and effective in the treatment of patients with VKC .

###26136584
BACKGROUND	There is minimal information on the impact of replacing sugar-sweetened beverage ( SSB ) consumption with water on diet quality from randomized controlled trials .
OBJECTIVE	We evaluated the effect of a water intake intervention on diet quality in overweight Mexican women .
METHODS	Women with a body mass index 25 and < 39 , 18-45 y old , and a self-reported high intake of SSBs ( 250 kcal/d ) were randomly allocated to either the water and education provision ( WEP ) group ( n = 120 ) or the education provision ( EP ) only group ( n = 120 ) .
METHODS	Each group received monthly nutrition counseling , and the WEP group received biweekly water deliveries for 9 mo. .
METHODS	Three 24-h recalls , anthropometry , and demographic information were collected at baseline , and 3 , 6 , and 9 mo. .
METHODS	Energy , macronutrient , sugar , SSB , fruit and vegetable , salty snack , cake and cookie , and fast food intakes were assessed in study completers ( n = 189 ) classified by intervention assignment and by actual water intake at every time point ( low < 1200 vs. high 1200 mL/d ) .
RESULTS	The WEP group reported greater decreases in SSB intake than the EP group ( from 20.9 % to 10.3 % of energy/d vs. from 20.1 % to 17.8 % ) .
RESULTS	Thirty-eight percent of the EP group and 84.3 % of the WEP group reported attaining a water intake 1200 mL/d .
RESULTS	Reductions in energy intake and food groups were similar across intervention groups .
RESULTS	However , the high actual water intake group reported greater increases vs. the lower intake group in intake of fruits and vegetables ( 117 vs. 47 g/d ) , as well as larger reductions in salty snacks ( 4.6 vs. 0.7 g/d ) and cakes and cookies ( 31.7 vs. 14.7 g/d ) .
CONCLUSIONS	Other than SSBs , improvements in food group intake did not differ by intervention group in overweight Mexican women .
CONCLUSIONS	However , post hoc analyses suggested that achieving a high actual water intake was associated with additional beneficial changes in food group intake .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01245010 .

###25460341
OBJECTIVE	This study aims to describe the process of conducting a randomized clinical trial of elderly with chronic dizziness subjected to vestibular rehabilitation ( VR ) and to verify its effectiveness on dizziness intensity .
METHODS	Older adults ( 65 years ) with chronic dizziness from vestibular disorders referred to VR were enrolled to the trial .
METHODS	The control group ( n = 40 ) was submitted to the Cawthorne & Cooksey protocol and the experimental group ( n = 42 ) to the modified Cawthorne & Cooksey protocol which included multiple components .
METHODS	Protocols were performed during individual 50-minute sessions , twice-weekly , for eight weeks .
METHODS	Main measures were : recruitment data ( refusal and eligibility ) , baseline characteristics , dropout rate , session attendance , protocol adherence , adverse effects , exercise adaptation and follow-up events .
METHODS	The Visual Analog Scale ( VAS ) was used to measure dizziness intensity .
RESULTS	144 elderly were referred to VR , 26.4 % declined to participate and 16.7 % were ineligible .
RESULTS	There were 51 session non-attendances , with disease being the most frequent reason .
RESULTS	Regardless of VR protocol , VAS dizziness intensity diminished along sessions ( p < 0.001 ) .
RESULTS	88.6 % of the participants reported improvement after treatment , and 22.9 % mentioned an increase in dizziness on follow-up .
RESULTS	Home exercises were no longer being performed by 21.4 % of the subjects after 3 months from discharge .
RESULTS	The final dropout rate was 14.6 % .
RESULTS	There were no differences between VR protocols on recruitment , dropout , session 's attendance , adherence to protocol and treatment effects .
CONCLUSIONS	Our results revealed many challenges in conducting a rehabilitation trial with an elderly sample .
CONCLUSIONS	The VR protocols showed to be feasible and suitable to reduce dizziness in older adults .

###25332065
BACKGROUND	Mental practice , the cognitive rehearsal of a task without physical movement , is known to enhance performance in sports and music .
BACKGROUND	Investigation of this technique in surgery has been limited to basic operations .
BACKGROUND	The purpose of this study was to develop mental practice scripts , and to assess their effect on advanced laparoscopic skills and surgeon stress levels in a crisis scenario .
METHODS	Twenty senior surgical trainees were randomized to either conventional training or mental practice groups , the latter being trained by an expert performance psychologist .
METHODS	Participants ' skills were assessed while performing a porcine laparoscopic jejunojejunostomy as part of a crisis scenario in a simulated operating room , using the Objective Structured Assessment of Technical Skill ( OSATS ) and bariatric OSATS ( BOSATS ) instruments .
METHODS	Objective and subjective stress parameters were measured , as well as non-technical skills using the Non-Technical Skills for Surgeons rating tool .
RESULTS	An improvement in OSATS ( P = 0.003 ) and BOSATS ( P = 0.003 ) scores was seen in the mental practice group compared with the conventional training group .
RESULTS	Seven of ten trainees improved their technical performance during the crisis scenario , whereas four of the ten conventionally trained participants deteriorated .
RESULTS	Mental imagery ability improved significantly following mental practice training ( P = 0.011 ) , but not in the conventional group ( P = 0.083 ) .
RESULTS	No differences in objective or subjective stress levels or non-technical skills were evident .
CONCLUSIONS	Mental practice improves technical performance for advanced laparoscopic tasks in the simulated operating room , and allows trainees to maintain or improve their performance despite added stress .

###25503617
OBJECTIVE	To determine the safety and tolerability of 3 doses of intranasal oxytocin ( Syntocinon ; Novartis , Bern , Switzerland ) administered to patients with frontotemporal dementia ( FTD ) .
METHODS	We conducted a randomized , parallel-group , double-blind , placebo-controlled study using a dose-escalation design to test 3 clinically feasible doses of intranasal oxytocin ( 24 , 48 , or 72 IU ) administered twice daily for 1 week to 23 patients with behavioral variant FTD or semantic dementia ( clinicaltrials.gov registration number NCT01386333 ) .
METHODS	Primary outcome measures were safety and tolerability at each dose .
METHODS	Secondary measures explored efficacy across the combined oxytocin vs placebo groups and examined potential dose-related effects .
RESULTS	All 3 doses of intranasal oxytocin were safe and well tolerated .
CONCLUSIONS	A multicenter trial is warranted to determine the therapeutic efficacy of long-term intranasal oxytocin for behavioral symptoms in FTD .
METHODS	This study provides Class I evidence that for patients with FTD , intranasal oxytocin is not significantly associated with adverse events or significant changes in the overall neuropsychiatric inventory .

###24886516
BACKGROUND	There is a need for cost-effective weight management interventions that primary care can deliver to reduce the morbidity caused by obesity .
BACKGROUND	Automated web-based interventions might provide a solution , but evidence suggests that they may be ineffective without additional human support .
BACKGROUND	The main aim of this study was to carry out a feasibility trial of a web-based weight management intervention in primary care , comparing different levels of nurse support , to determine the optimal combination of web-based and personal support to be tested in a full trial .
METHODS	This was an individually randomised four arm parallel non-blinded trial , recruiting obese patients in primary care .
METHODS	Following online registration , patients were randomly allocated by the automated intervention to either usual care , the web-based intervention only , or the web-based intervention with either basic nurse support ( 3 sessions in 3months ) or regular nurse support ( 7 sessions in 6months ) .
METHODS	The main outcome measure ( intended as the primary outcome for the main trial ) was weight loss in kg at 12months .
METHODS	As this was a feasibility trial no statistical analyses were carried out , but we present means , confidence intervals and effect sizes for weight loss in each group , uptake and retention , and completion of intervention components and outcome measures .
RESULTS	All randomised patients were included in the weight loss analyses ( using Last Observation Carried Forward ) .
RESULTS	At 12months mean weight loss was : usual care group ( n = 43 ) 2.44 kg ; web-based only group ( n = 45 ) 2.30 kg ; basic nurse support group ( n = 44 ) 4.31 kg ; regular nurse support group ( n = 47 ) 2.50 kg .
RESULTS	Intervention effect sizes compared with usual care were : d = 0.01 web-based ; d = 0.34 basic nurse support ; d = 0.02 regular nurse support .
RESULTS	Two practices deviated from protocol by providing considerable weight management support to their usual care patients .
CONCLUSIONS	This study demonstrated the feasibility of delivering a web-based weight management intervention supported by practice nurses in primary care , and suggests that the combination of the web-based intervention with basic nurse support could provide an effective solution to weight management support in a primary care context .
BACKGROUND	Current Controlled Trials ISRCTN31685626 .

###24709874
OBJECTIVE	To determine the time-wise effect of specific resistance training on neck pain among industrial technicians with frequent neck pain symptoms .
METHODS	Secondary analysis of a parallel-group cluster randomized controlled trial of 20 weeks performed at two large industrial production units in Copenhagen , Denmark .
METHODS	Women with neck pain > 30 mm VAS ( N = 131 ) were included in the present analysis .
METHODS	The training group ( N = 77 ) performed specific resistance training for the neck/shoulder muscles three times a week , and the control group ( N = 54 ) received advice to stay active .
METHODS	Participants of both groups registered neck pain intensity ( 0-100 mm VAS ) once a week .
RESULTS	Neck pain intensity was 55 mm ( SD 23 ) at baseline .
RESULTS	There was a significant group by time interaction for neck pain ( F-value 2.61 , P < 0.001 , DF = 19 ) .
RESULTS	Between-group differences in neck pain reached significance after 4 weeks ( 11 mm , 95 % CI 2 to 20 ) .
RESULTS	The time-wise change in pain showed three phases ; a rapid decrease in the training group compared with the control group during the initial 7 weeks , a slower decrease in pain during the following weeks ( week 8-15 ) , and a plateau during the last weeks ( week 16-20 ) .
RESULTS	Adherence to training followed a two-phase pattern , i.e. weekly participation rate was between 70-86 % during the initial 7 weeks , dropping towards 55-63 % during the latter half of the training period .
CONCLUSIONS	Four weeks of specific resistance training reduced neck pain significantly , but 15 weeks is required to achieve maximal pain reduction .
CONCLUSIONS	The time-wise change in pain followed a three-phase pattern with a rapid effect during the initial 7 weeks followed by a slower but still positive effect , and finally a plateau from week 15 and onwards .
CONCLUSIONS	Decreased participation rate may explain the decreased efficacy during the latter phase of the intervention .

###24687764
OBJECTIVE	The authors of this quasi-experimental design study explored the effect of an educational documentary video that presented factual and emotional aspects of stuttering on changing attitudes toward stuttering of preservice trainees and in-service public school teachers in Kuwait .
METHODS	Participants were 99 preservice trainees ( 48 control , 51 experimental ) and 103 in-service teachers ( 49 control , 54 experimental ) .
METHODS	All participants completed 22 items from the Public Opinion Survey of Human Attributes-Stuttering ( POSHA-S ; St. Louis , 2005 ; translated into Arabic ) and 17 additional items pre and post treatment .
METHODS	Participants in the experimental group viewed the awareness video .
RESULTS	Pretreatment comparisons confirmed that the control and experimental groups did not differ on their attitudes toward stuttering .
RESULTS	As predicted , the posttreatment ratings for the control group were not different from the pretreatment ratings .
RESULTS	A significant shift in attitudes ( mostly in a positive direction ) from pre to post treatment was observed for the experimental group of preservice trainees but not for the experimental group of in-service teachers .
RESULTS	Interpretation of the difference in outcomes for the experimental preservice group as compared to the experimental in-service group is confounded by gender differences across groups .
CONCLUSIONS	The authors of this study demonstrated that it is possible to positively modify preservice trainees ' attitudes of people who stutter by using an educational documentary video .

###25482330
BACKGROUND	We did a phase 3 study in previous non-responders with chronic hepatitis C virus ( HCV ) genotype 1 infection and compensated liver disease that related to the standard of care for these patients at the time this study was initiated .
BACKGROUND	We investigated whether simeprevir is non-inferior in terms of efficacy to telaprevir , each in combination with peginterferon alfa-2a and ribavirin .
METHODS	We did this randomised , double-blind , phase 3 trial at 169 investigational sites in 24 countries .
METHODS	We enrolled adults ( 18 years ) with chronic HCV genotype 1 infection , compensated liver disease , and plasma HCV RNA higher than 10000 IU/mL who were null or partial responders during at least one previous course of peginterferon alfa-2a and ribavirin treatment .
METHODS	We randomly assigned ( 1:1 ) patients ( stratified by HCV genotype 1 subtype [ 1a plus other/1b ] and previous treatment response [ partial or null ] ) to receive simeprevir ( 150 mg once a day ) plus telaprevir placebo ( three times a day 7-9 h apart ) or telaprevir ( 750 mg three times a day ) plus simeprevir placebo ( once a day ) in combination with peginterferon alfa-2a and ribavirin for 12 weeks followed by 36 weeks of peginterferon alfa-2a and ribavirin alone .
METHODS	The primary efficacy endpoint was sustained virological response 12 weeks after end of treatment ( SVR12 ) in the intention-to-treat and the per-protocol population .
METHODS	We compared groups with the Cochran-Mantel-Haenszel test .
METHODS	We established a non-inferiority margin of 12 % .
METHODS	Adverse events were reported descriptively .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01485991 .
RESULTS	Patient screening began on Jan 19 , 2012 , and the last visit was on April 7 , 2014 .
RESULTS	We included 763 patients ( 472 previous null responders [ 62 % ] ) .
RESULTS	Simeprevir and peginterferon alfa-2a and ribavirin was non-inferior to telaprevir and peginterferon alfa-2a and ribavirin for SVR12 ( 54 % [ 203/379 ] vs 55 % [ 210/384 ] ; difference -11 % , 95 % CI -78 to 55 ; p = 00007 ) .
RESULTS	SVR12 was achieved in 70 % ( 101/145 ) versus 68 % ( 100/146 ) of previous partial responders and 44 % ( 102/234 ) versus 46 % ( 110/238 ) of previous null responders with simeprevir and peginterferon alfa-2a and ribavirin and telaprevir and peginterferon alfa-2a and ribavirin treatment , respectively .
RESULTS	We recorded differences between treatment groups in simeprevir or telaprevir-related adverse events ( 69 % [ 261/379 ] in the simeprevir group vs 86 % [ 330/384 ] in the telaprevir group ) , serious adverse events ( 2 % [ 8/379 ] vs 9 % [ 33/384 ] ) , and adverse events leading to simeprevir or telaprevir discontinuation ( 2 % [ 7/379 ] vs 8 % [ 32/384 ] ) .
CONCLUSIONS	Simeprevir once a day with peginterferon alfa-2a and ribavirin was well tolerated in HCV genotype 1-infected previous non-responders and was non-inferior to telaprevir , thus providing an alternative treatment in areas of the world where all-oral HCV regimens are not available or accessible .
BACKGROUND	Janssen .

###24746224
BACKGROUND	Chronic neck pain ( CNP ) is a common painful medical condition with a significant socioeconomic impact .
BACKGROUND	In spite of widespread usage , the effectiveness and safety of combined treatments between conventional and complementary alternative medical treatment modalities has not been fully established in a rigorous randomized clinical trial ( RCT ) .
BACKGROUND	This pilot study will provide the clinical evidence to evaluate the feasibility and refine the protocol for a full-scale RCT on combined treatment of bee venom acupuncture ( BVA ) and non-steroidal anti-inflammatory drugs ( NSAIDs ) in patients with CNP .
METHODS	This is a randomized , single-blind clinical trial with three parallel arms .
METHODS	Sixty patients between 18 and 65years of age with non-specific , uncomplicated neck pain lasting for at least three months will be enrolled .
METHODS	Participants will be randomly allocated into the BVA , NSAIDs or combined treatment group .
METHODS	Assessors and statisticians will be blinded to the random allocation .
METHODS	All researchers will receive training to ensure their strict adherence to the study protocol .
METHODS	Patients from the BVA and combined treatment group will be treated with a bee venom increment protocol into predefined acupoints for six sessions over a three week period .
METHODS	BVA intervention is developed through a comprehensive discussion among interdisciplinary spine disorder experts , according to the guidelines of Standards for Reporting Interventions in Clinical Trials of Acupuncture ( STRICTA ) .
METHODS	Patients from the NSAIDs and combined treatment groups will be prescribed loxoprofen ( one tablet to be taken orally , three times a day for three weeks ) .
METHODS	Bothersomeness from CNP measured using a visual analogue scale ( VAS ) will be the primary outcome assessed at screening , visit two ( baseline ) , four , six , eight ( 4th week assessment ) and nine ( 8th week assessment ) follow-up session .
METHODS	VAS for pain intensity , neck disability index ( NDI ) , quality of life , depressive status and adverse experiences will also be analyzed .
CONCLUSIONS	Our study results will contribute to feasibility evaluation and to relevant RCT protocol development for a full-scale RCT on combined treatment of BVA and NSAIDs for CNP patients .
BACKGROUND	This study is registered with the United States ( US ) National Institutes of Health Clinical Trials Registry : NCT01922466 .

###24946626
OBJECTIVE	To discuss the impacts of moxibustion for regulating spleen and stomach function on the survival quality of the patients of end stage renal disease ( ESRD ) with maintenance hemodialysis ( MHD ) .
METHODS	One hundred and nine cases of uremia with MHD from 3 hemodialysis centers were randomized into an observation group ( 58 cases ) and a control group ( 51 cases ) .
METHODS	The regular hemodialysis and conventional medication were used in the two groups .
METHODS	In the observation group , on the basis of the common treatment , moxibustion was applied to Zusanli ( ST 36 ) and Sanyinjiao ( SP 6 ) , 2-3 times a day , the treatment of 4 weeks made one session .
METHODS	Totally , 3 sessions were required and the follow-up lasted for 3 months .
METHODS	KDQOL-SF ( kidney disease quality of life short form,KDQOL-SFTM 1.3 ) was adopted for the questionnaire investigation on survival quality before treatment , after treatment and at the end of follow-up separately in the two groups .
RESULTS	After treatment , the survival quality scores in terms of physical functioning ( 83.62 + / -13.27 vs 79.32 + / - 22.17 ) , general health ( 58.88 + / - 20.24 vs 48.82 + / -20.89 ) and vitality ( 77.07 + / -15.56 vs 70.59 + / -22.61 ) in the observation group were higher than those in the control group ( all P < 0.05 ) .
RESULTS	In comparison before and after treatment in the same group , the survival quality scores in terms of physical functioning , general health , vitality and symptoms/problems were all improved in the observation group ( all P < 0.05 ) .
RESULTS	At the end of follow-up , the survival quality scores in terms of physical functioning , general health , mental health , social functioning , vitality , effects of kidney disease and cognitive function were higher in the observation group as compared with those in the control group ( all P < 0.05 ) .
RESULTS	In comparison of the results at the end of follow-up with those before treatment , the survival quality scores in terms of vitality , symptoms/problems and cognitive function in the observation group were improved ( all P < 0.05 ) .
RESULTS	The differences were not significant in all of the 19 fields of survival quality evaluation before and after treatment , and after follow-up in the control group ( all P > 0.05 ) .
CONCLUSIONS	Moxibustion for regulating spleen and stomach function improves the survival quality of the patients with hemodialysis in terms of physical functioning , general health and vitality , which benefits the psychological condition of the patients , resulting in the improvements of the survival quality in the fields of mental health , social functioning , effects of kidney disease and cognitive function .

###25311554
OBJECTIVE	The optimal duration of a public heart failure ( HF ) clinic programme is unknown .
OBJECTIVE	This substudy of the NT-proBNP stratified follow-up in outpatient heart failure clinics ( NorthStar ) trial was designed to evaluate the effect of extended follow-up in an outpatient HF clinic on long-term adherence to guideline-based therapy .
RESULTS	Patients with HF with reduced EF on optimal medical therapy ( n = 921 ) were randomized to either extended follow-up in the HF clinic ( n = 461 ) or discharge to primary care ( n = 460 ) and followed for a median of 4.1 years ( range : 13 months to 6.1 years ) .
RESULTS	The effect of the HF clinic intervention on treatment adherence ( time to at least a 90 day break in treatment ) was estimated by drug dispensing from pharmacies of an ACE inhibitor/ARB , beta-blocker ( BB ) , or mineralocorticoid receptor antagonist ( MRA ) .
RESULTS	Median age was 69 years , 25 % were females , LVEF was 30 % , and 90 % were in NYHA class II-III .
RESULTS	The HF clinic intervention did not reduce time to a 90 day break in treatment with either an ACE inhibitor/ARB [ hazard ratio ( HR ) 0.82 , 95 % confidence interval ( CI ) 0.34-1 .97 , P = 0.650 ] , a BB ( HR 1.09 , 95 % CI 0.53-2 .66 , P = 0.820 ) , or an MRA ( HR 1.30 , 95 % CI 0.85-2 .00 , P = 0.238 ) .
CONCLUSIONS	Extended follow-up in an outpatient HF clinic did not improve long-term adherence to guideline-based therapy , and adherence did not deteriorate when follow-up was shifted from the HF clinic to primary care .

###25247318
BACKGROUND	This phase II , open-label , randomised study evaluated whether patients with metastatic pancreatic cancer receiving erlotinib/gemcitabine derived survival benefits from increasing the erlotinib dose .
METHODS	After a 4-week run-in period ( gemcitabine 1000 mg m ( -2 ) once weekly plus erlotinib 100 mg per day ) , patients with metastatic pancreatic cancer who developed grade 0/1 rash were randomised to receive gemcitabine plus erlotinib dose escalation ( 150 mg , increasing by 50 mg every 2 weeks ( maximum 250 mg ) ; n = 71 ) or gemcitabine plus standard-dose erlotinib ( 100 mg per day ; n = 75 ) .
METHODS	The primary end point was to determine whether overall survival ( OS ) was improved by increasing the erlotinib dose .
METHODS	Secondary end points included progression-free survival ( PFS ) , incidence of grade 2 rash , and safety .
RESULTS	Erlotinib dose escalation induced grade 2 rash in 29 out of 71 ( 41.4 % ) patients compared with 7 out of 75 ( 9.3 % ) patients on standard dose .
RESULTS	Efficacy was not significantly different in the dose-escalation arm compared with the standard-dose arm ( OS : median 7.0 vs 8.4 months , respectively , hazard ratio ( HR ) , 1.26 , 95 % confidence interval ( CI ) : 0.88-1 .80 ; P = 0.2026 ; PFS : median 3.5 vs 4.5 months , respectively , HR , 1.09 , 95 % CI : 0.77-1 .54 ; P = 0.6298 ) .
RESULTS	Incidence of adverse events was comparable between randomised arms .
CONCLUSIONS	The erlotinib dose-escalation strategy induced rash in some patients ; there was no evidence that the higher dose translated into increased benefit .

###25885862
BACKGROUND	Globally , non-attendance for immunization appointments remains a challenge to healthcare providers .
BACKGROUND	A review of the 2011 immunization coverage for Kadoma City , Zimbabwe was 74 % for Oral Polio Vaccine ( OPV ) , Pneumococcal and Pentavalent antigens .
BACKGROUND	The immunization coverage was less than 90 % , which is the target for Kadoma City .
BACKGROUND	Adoption of short message services ( SMS ) reminders has been shown to enhance attendance in some medical settings .
BACKGROUND	The study was conducted to determine the effectiveness of SMS reminders on immunization programme for Kadoma City .
METHODS	A randomized controlled trial was conducted at Kadoma City clinics in Zimbabwe .
METHODS	Women who delivered and were residents of Kadoma City were recruited into the study .
METHODS	In the intervention group , SMS reminders were sent at 6 , 10 and 14weeks in addition to routine health education .
METHODS	In the non-intervention no SMS reminders were used , however routine health education was offered .
METHODS	Data were collected using interviewer administered questionnaire .
METHODS	Data were analyzed using Epi Info 7 , where frequencies , means , risk ratios and risk differences were generated .
RESULTS	A total of 304 participants were recruited , 152 for the intervention group and 152 for the non-intervention group .
RESULTS	The immunization coverage at 6weeks was 97 % in the intervention group and 82 % in the non-intervention group ( p < 0.001 ) .
RESULTS	At 14weeks immunization coverage was 95 % for intervention and 75 % for non-intervention group ( p < 0.001 ) .
RESULTS	Those who did not delay receiving immunization at 14weeks was 82 % for the intervention and 8 % for non-intervention group .
RESULTS	Median delay for intervention was 0days ( Q1 = 0 ; Q3 = 0 ) and 10days ( Q1 = 6 ; Q3 = 17 ) for non-intervention group .
RESULTS	The risk difference ( RD ) for those who received SMS reminders than those in the non intervention group was 16.3 % ( 95 % CI : 12.5-28 .0 ) at 14weeks .
CONCLUSIONS	Immunization coverage in the intervention group was significantly higher than in non-intervention group .
CONCLUSIONS	Overall increase in immunization coverage can be attributed to use of SMS .
BACKGROUND	ISRCTN70918594 .
BACKGROUND	Registration Date : 28 August 2014 .

###25091090
BACKGROUND	Psoriasis and psoriatic arthritis ( PsA ) impair quality of life , including reduction in employment or job duties .
BACKGROUND	The PRESTA ( Psoriasis Randomized Etanercept STudy in Patients with Psoriatic Arthritis ) study , a randomized , double-blind , two-dose trial , examined the efficacy of etanercept treatment in patients with moderate-to-severe plaque psoriasis and PsA and the main results have been presented previously .
BACKGROUND	This analysis examined employment status , job duties and sick days , pre-defined endpoints in PRESTA , among this patient population .
METHODS	Participants ( N = 752 ) were randomized to receive etanercept 50 mg twice weekly ( BIW ; n = 379 ) or 50 mg once weekly ( QW ; n = 373 ) for 12 weeks by subcutaneous injection .
METHODS	All participants then received open-label etanercept 50 mg QW for 12 additional weeks , while remaining blinded to the randomization .
METHODS	A pharmacoeconomic questionnaire was administered at baseline , week 12 and week 24 of treatment .
METHODS	The questionnaire included employment status and changing job responsibilities and sick time taken due to psoriasis or PsA .
METHODS	The statistical methods included analysis of covariance , t-test , Fisher 's exact test and McNemar 's test .
METHODS	Last-observation-carried-forward imputation was used for missing data .
RESULTS	Employment was at least maintained from baseline to week 24 in both dose groups ( 56 % [ BIW/QW ] and 60 % [ QW/QW ] at baseline , 61 % and 60 % , respectively , at week 24 ) .
RESULTS	Among employed participants , the proportion of patients whose job responsibilities changed due to PsA decreased significantly from baseline to week 24 ( 17-23 % to 5-8 % ; p < 0.01 ) .
RESULTS	Similar results were seen with job responsibility changes due to psoriasis ( 11-14 % to 4 % ; p < 0.01 ) .
RESULTS	The number of monthly sick days also decreased from baseline to week 24 ( 2.4 days for both treatment groups to 0.7 ( BIW/QW ) and 1.1 ( QW/QW ) ; p0 .03 for each ) .
RESULTS	No significant differences between the treatment groups were observed for any economic endpoint at any time point .
CONCLUSIONS	For patients with moderate-to-severe plaque psoriasis and PsA , etanercept treatment resulted in reducing job responsibility changes due to disease and in reducing sick time .
CONCLUSIONS	Effective treatment of psoriasis and PsA may reduce missed work days .

###24252551
BACKGROUND	A decision of the Federal Joint Committee Germany in 2008 stated that negative pressure wound therapy is not accepted as a standard therapy for full reimbursement by the health insurance companies in Germany .
BACKGROUND	This decision is based on the final report of the Institute for Quality and Efficiency in Health Care in 2006 , which demonstrated through systematic reviews and meta-analysis of previous study projects , that an insufficient state of evidence regarding the use of negative pressure wound therapy for the treatment of acute and chronic wounds exists .
BACKGROUND	Further studies were therefore indicated .
METHODS	The study is designed as a multinational , multicenter , prospective randomized controlled , adaptive design , clinical superiority trial , with blinded photographic analysis of the primary endpoint .
METHODS	Efficacy and effectiveness of negative pressure wound therapy for wounds in both medical sectors ( in - and outpatient care ) will be evaluated .
METHODS	The trial compares the treatment outcome of the application of a technical medical device which is based on the principle of negative pressure wound therapy ( intervention group ) and standard conventional wound therapy ( control group ) in the treatment of subcutaneous abdominal wounds after surgery .
METHODS	The aim of the SAWHI-VAC study is to compare the clinical , safety and economic results of both treatment arms .
CONCLUSIONS	The study project is designed and conducted with the aim of providing solid evidence regarding the efficacy of negative pressure wound therapy .
CONCLUSIONS	Study results will be provided until the end of 2014 to contribute to the final decision of the Federal Joint Committee Germany regarding the general admission of negative pressure wound therapy as a standard of performance within both medical sectors .
BACKGROUND	Clinical Trials.gov NCT01528033German Clinical Trials Register DRKS00000648 .

###25503549
OBJECTIVE	Cough protects the lungs from aspiration .
OBJECTIVE	We investigated whether respiratory muscle training may improve respiratory muscle and cough function , and potentially reduce pneumonia risk in acute stroke .
METHODS	We conducted a single-blind randomized placebo-controlled trial in 82 patients with stroke ( mean age , 6414 years ; 49 men ) within 2 weeks of stroke onset .
METHODS	Participants were masked to treatment allocation and randomized to 4 weeks of daily expiratory ( n = 27 ) , inspiratory ( n = 26 ) , or sham training ( n = 25 ) , using threshold resistance devices .
METHODS	Primary outcome was the change in peak expiratory cough flow of maximal voluntary cough .
METHODS	Intention-to-treat analyses were conducted using ANCOVA , adjusting for baseline prognostic covariates .
RESULTS	There were significant improvements in the mean maximal inspiratory ( 14 cmH2O ; P < 0.0001 ) and expiratory ( 15 cmH2O ; P < 0.0001 ) mouth pressure and peak expiratory cough flow of voluntary cough ( 74 L/min ; P = 0.0002 ) between baseline and 28 days in all groups .
RESULTS	Peak expiratory cough flow of capsaicin-induced reflex cough was unchanged .
RESULTS	There were no between-group differences that could be attributed to respiratory muscle training .
RESULTS	There were also no differences in the 90-day incidence of pneumonia between the groups ( P = 0.65 ) .
CONCLUSIONS	Respiratory muscle function and cough flow improve with time after acute stroke .
CONCLUSIONS	Additional inspiratory or expiratory respiratory muscle training does not augment or expedite this improvement .
BACKGROUND	http://www.controlled-trials.com .
BACKGROUND	Unique identifier : ISRCTN40298220 .

###25534388
OBJECTIVE	To determine whether prolonged androgen suppression ( AS ) duration before radiotherapy improves survival and disease control in prostate cancer .
METHODS	One thousand five hundred seventy-nine men with intermediate-risk prostate cancer were randomly assigned to 8 weeks of AS followed by radiotherapy with an additional 8 weeks of concurrent AS ( 16 weeks total ) or to 28 weeks of AS followed by radiotherapy with an additional 8 weeks of AS ( 36 weeks total ) .
METHODS	The trial sought primarily to detect a 33 % reduction in the hazard of prostate cancer death in the 28-week assignment .
METHODS	Time-to-event end points are reported for up to 10 years of follow-up .
RESULTS	There were no between-group differences in baseline characteristics of 1,489 eligible patients with follow-up .
RESULTS	For the 8 - and 28-week assignments , 10-year disease-specific survival rates were 95 % ( 95 % CI , 93.3 % to 97.0 % ) and 96 % ( 95 % CI , 94.6 % to 98.0 % ; hazard ratio [ HR ] , 0.81 ; P = .45 ) , respectively , and 10-year overall survival rates were 66 % ( 95 % CI , 62.0 % to 69.9 % ) and 67 % ( 95 % CI , 63.0 % to 70.8 % ; HR , 0.95 ; P = .62 ) , respectively .
RESULTS	For the 8 - and 28-week assignments , 10-year cumulative incidences of locoregional progression were 6 % ( 95 % CI , 4.3 % to 8.0 % ) and 4 % ( 95 % CI , 2.5 % to 5.7 % ; HR , 0.65 ; P = .07 ) , respectively ; 10-year distant metastasis cumulative incidences were 6 % ( 95 % CI , 4.0 % to 7.7 % ) and 6 % ( 95 % CI , 4.0 % to 7.6 % ; HR , 1.07 ; P = .80 ) , respectively ; and 10-year prostate-specific antigen-based recurrence cumulative incidences were 27 % ( 95 % CI , 23.1 % to 29.8 % ) and 27 % ( 95 % CI , 23.4 % to 30.3 % ; HR , 0.97 ; P = .77 ) , respectively .
CONCLUSIONS	Extending AS duration from 8 weeks to 28 weeks before radiotherapy did not improve outcomes .
CONCLUSIONS	A lower than expected prostate cancer death rate reduced ability to detect a between-group difference in disease-specific survival .
CONCLUSIONS	The schedule of 8 weeks of AS before radiotherapy plus 8 weeks of AS during radiotherapy remains a standard of care in intermediate-risk prostate cancer .

###24408116
OBJECTIVE	Angiotensin-converting enzyme inhibitors and angiotensin receptor blockers are the cornerstones of pharmacologic therapy in diabetic nephropathy .
OBJECTIVE	Mineralocorticoid receptor blockers reduce proteinuria as single agents or add-on therapy to other renin-angiotensin-aldosterone system-inhibiting drugs in these patients .
OBJECTIVE	The long-term benefits and ultimate role of mineralocorticoid receptor blockers in diabetic nephropathy remain unknown .
OBJECTIVE	A clinical trial previously showed that the kalemic effect of spironolactone is higher than losartan when added to lisinopril in patients with diabetic nephropathy .
OBJECTIVE	The purpose of this study was to investigate if renal potassium handling was primarily responsible for that observation .
METHODS	In a blinded , randomized , three-arm placebo-controlled clinical trial , 80 participants with diabetic nephropathy taking lisinopril ( 80 mg ) were randomized to spironolactone ( 25 mg daily ) , losartan ( 100 mg daily ) , or placebo ( trial dates from July of 2003 to December of 2006 ) .
METHODS	Serum potassium , aldosterone , and 24-hour urine sodium , potassium , and creatinine were measured over 48 weeks .
METHODS	Differences were analyzed with repeated measures mixed models .
RESULTS	Mean follow-up serum potassium was 5.0 mEq/L for spironolactone , 4.7 mEq/L for losartan ( P = 0.05 versus spironolactone ) , and 4.5 mEq/L for placebo ( P < 0.001 versus spironolactone ; P = 0.03 versus losartan ) .
RESULTS	The difference in serum potassium was 0.23 mEq/L for losartan versus placebo ( P = 0.02 ) , 0.43 mEq/L for spironolactone versus placebo ( P < 0.001 ) , and 0.2 mEq/L for spironolactone versus losartan ( P = 0.05 ) .
RESULTS	Serum and urine potassium excretion and secretion rates were similar between groups throughout the study .
CONCLUSIONS	Spironolactone raised serum potassium more than losartan in patients with diabetic nephropathy receiving lisinopril , despite similar renal sodium and potassium excretion .
CONCLUSIONS	This finding suggests that extrarenal potassium homeostasis contributes to hyperkalemia in these patients .
CONCLUSIONS	A better understanding of extrarenal potassium homeostasis will provide an opportunity to use this drug more safely in patients with diabetic nephropathy as well as other patient populations .

###25899736
BACKGROUND	The management of postoperative pain is paramount to facilitate the delivery of day case surgical programs .
BACKGROUND	In recent years , the complexity of procedures carried out has increased to include laparoscopic cholecystectomy .
BACKGROUND	The aim of this study was to evaluate the impact of laparoscopic-assisted 4-quadrant transversus abdominis plane ( TAP ) block vs periportal local anesthetic wound infiltration in managing postoperative pain .
METHODS	A prospective , randomized , double-blinded trial was conducted with patients undergoing elective laparoscopic cholecystectomy .
METHODS	Patients were randomized using computerized `` random number table '' into a test group that received laparoscopic-assisted TAP block with bupivacaine with periportal saline injection and a control group that received a laparoscopic-assisted TAP block with saline and periportal bupivacaine .
METHODS	All patients received intraperitoneal instillation of bupivacaine in the gallbladder bed .
METHODS	Postoperative pain scores were recorded using numerical rating scores at rest and coughing at dedicated time points .
METHODS	Statistical analysis was carried out using GraphPad Prism software , version 5 ( GraphPad Software ) and p < 0.05 was considered significant .
RESULTS	Eighty patients ( 70 female and 10 male ) were enrolled ; 40 patients were randomized to each group .
RESULTS	Age , American Society of Anesthesiologists score , operative time , and BMI were comparable between the groups .
RESULTS	No adverse events were encountered with the administration of TAP blocks .
RESULTS	Numerical rating scores were significantly reduced in the test group at 1 , 3 , and 6 hours at rest ( p = 0.025 , p = 0.03 , and p = 0.007 , respectively ) .
RESULTS	Numerical rating score was significantly reduced at 1 , 3 , and 6 hours during coughing ( p = 0.026 , p = 0.02 , and p = 0.03 , respectively ) .
RESULTS	Difference in postoperative analgesic requirements between both groups was statistically insignificant ( p = 0.17 ) .
CONCLUSIONS	This analysis has confirmed the therapeutic benefit of laparoscopically delivered TAP blocks in elective laparoscopic cholecystectomy .

###25486269
BACKGROUND	Sex differences in Parkinson disease clinical features have been reported , but few studies have examined sex influences on use of dopaminergic medication in early Parkinson disease .
BACKGROUND	The objective of this study was to test if there are differences in the type of dopaminergic medication used and levodopa equivalent daily dose between men and women with early Parkinson disease enrolled in a large multicenter study of Creatine as a potential disease modifying therapy - the National Institute of Neurological Disorders and Stroke Exploratory Trials in Parkinson Disease Long-Term Study-1 .
METHODS	Baseline data of 1,741 participants from 45 participating sites were analyzed .
METHODS	Participants from the United States and Canada were enrolled within five years of Parkinson Disease diagnosis .
METHODS	Two outcome variables were studied : type of dopaminergic medication used and levodopa equivalent daily dose at baseline in the Long-Term Study-1 .
METHODS	Chi-square statistic and linear regression models were used for statistical analysis .
RESULTS	There were no statistically significant differences in the frequency of use of different types of dopaminergic medications at baseline between men and women with Parkinson Disease .
RESULTS	A small but statistically significant difference was observed in the median unadjusted levodopa equivalent daily dose at baseline between women ( 300 mg ) and men ( 325 mg ) , but this was not observed after controlling for disease duration ( years since Parkinson disease diagnosis ) , disease severity ( Unified Parkinson 's Disease Rating Scale Motor and Activities of Daily Living Scores ) , and body weight .
CONCLUSIONS	In this large multicenter study , we did not observe sex differences in the type and dose of dopaminergic medications used in early Parkinson Disease .
CONCLUSIONS	Further research is needed to evaluate the influence of male or female sex on use of dopaminergic medication in mid - and late-stage Parkinson Disease .

###24794451
OBJECTIVE	to evaluate the clinical , hemodynamic , gas analysis and metabolic repercussions of high transient pressures of pneumoperitoneum for a short period of time to ensure greater security for introduction of the first trocar .
METHODS	sixty-seven patients undergoing laparoscopic procedures were studied and randomly distributed in P12 group : n = 30 ( intraperitoneal pressure [ IPP ] 12mmHg ) and P20 group : n = 37 ( IPP of 20mmHg ) .
METHODS	Mean arterial pressure ( MAP ) was evaluated by catheterization of the radial artery ; and through gas analysis , pH , partial pressure of oxygen ( PaO2 ) , partial pressure of CO2 ( PaCO2 ) , bicarbonate ( HCO3 ) and alkalinity ( BE ) were evaluated .
METHODS	These parameters were measured in both groups at time zero before pneumoperitoneum ( TP0 ) ; at time 1 ( TP1 ) when IPP reaches 12mmHg in both groups ; at time 2 ( TP2 ) after five min with IPP = 12mmHg in P12 and after 5min with IPP = 20mmHg at P20 ; and at time 3 ( TP3 ) after 10min with IPP = 12mmHg in P12 and with return of IPP from 20 to 12mmHg , starting 10min after TP1 in P20 .
METHODS	Different values from those considered normal for all parameters assessed , or the appearance of atypical organic phenomena , were considered as clinical changes .
RESULTS	there were statistically significant differences in P20 group in MAP , pH , HCO3 and BE , but within normal limits .
RESULTS	No clinical and pathological changes were observed .
CONCLUSIONS	high and transient intra-abdominal pressure causes changes in MAP , pH , HCO3 and BE , but without any clinical impact on the patient .

###25291409
OBJECTIVE	To evaluate the effect of oral prednisolone on recovery from tonsillectomy .
METHODS	Prospective , randomized , controlled trial of 198 consecutive patients , aged 4 years and older , with no previous or known contraindications to steroid therapy .
METHODS	All 198 patients scheduled for elective tonsillectomy with or without adenoidectomy from April 2013 to April 2014 were included .
METHODS	The participants were then randomly assigned to receive a postoperative course of prednisolone 0.25 mg/kg/d or no prednisolone over 7 days .
METHODS	During the first postoperative day , pain , type of diet ( none , fluid , soft , normal ) , type of activity ( none , bed rest , quiet , restricted , normal ) , presence of nausea and vomiting , postoperative bleeding rate , and sleep disturbance were assessed using questionnaires .
METHODS	All patients were followed up on days 7 and 14 by endoscopic photographic examination of both tonsillar fossa and by completion of questionnaires .
RESULTS	No statistically significant differences in pain , diet , activity , rate of minor bleeding , nausea/vomiting , fever , or sleep disturbance were observed between the groups on day 1 .
RESULTS	On day 7 , however , in pediatric patients , differences in pain ( P = .001 ) , diet ( P = .001 ) , activity ( P = .004 ) , mean area of re-epithelialization ( P = .000 ) , fever ( P = .04 ) , and sleep disturbance ( P = .04 ) were observed .
RESULTS	On day 14 , differences in the mean area of re-epithelialization ( P = .000 , .001 ) remained in both pediatric and adult patients .
CONCLUSIONS	Oral prednisolone may be beneficial during recovery from tonsillectomy without causing any serious complications .

###25147225
BACKGROUND	Advanced glycation end products and their cell-bound receptors are thought to mediate the adverse effects of vascular disease through oxidative stress , inflammation and endothelial dysfunction .
BACKGROUND	We examined the association between the soluble form of receptor for advanced glycation end products ( sRAGE ) and kidney disease .
METHODS	In this case-cohort study nested within the Atherosclerosis Risk in Communities ( ARIC ) study , baseline sRAGE levels were measured in a cohort random sample of participants without kidney disease ( n = 1218 ) , and among participants who developed incident chronic kidney disease ( CKD ) [ estimated glomerular filtration rate ( eGFR ) < 60 mL/min/1 .73 m ( 2 ) and 25 % eGFR decline , n = 151 ] and end-stage renal disease ( ESRD ) [ entry in the US Renal Data System ( USRDS ) registry , n = 152 ] .
RESULTS	Baseline sRAGE levels were inversely related to baseline eGFR ( r = -0.13 ) .
RESULTS	After adjusting for age , sex and race , one interquartile range higher log10-transformed sRAGE was associated with development of CKD [ odds ratio : 1.39 ; 95 % confidence interval ( 95 % CI ) 1.06-1 .83 ; P = 0.02 ] and ESRD ( hazard ratio : 1.97 ; 95 % CI 1.47-2 .64 ; P < 0.001 ) .
RESULTS	These associations were not significant after eGFR adjustment .
CONCLUSIONS	High sRAGE levels are associated with incident CKD and ESRD risk , but not after adjustment for kidney function at baseline .
CONCLUSIONS	Future studies are needed to investigate specific mechanisms underlying the association of sRAGE with kidney disease risk .

###26193339
OBJECTIVE	The continuous progress in treatment options for pancreatic adenocarcinoma has lead to a re-evaluation of prognostic markers .
OBJECTIVE	In this study the prognostic relevance of DNA Index and classical histopathological parameters with regard to disease-free ( DFS ) and overall survival ( OS ) was analyzed within the CONKO-001 patient population .
METHODS	One hundred forty three fresh-frozen paraffin-embedded tissue samples of the resected tumor specimen of the CONKO-001 patient population were available for DNA index analysis to evaluate its impact on patient outcome .
RESULTS	Median DFS ( 7.3 vs. 14.3 months ; P = 0.004 ) and median OS ( 16.6 vs. 29.2 months ; P = 0.011 ) were significantly decreased in patients with a high DNA index ( > 1.4 ) .
RESULTS	Multivariate analysis revealed both DNA index ( DFS : P = 0.002 ; OS : P = 0.019 ) and tumor grading ( DFS : P = 0.004 ; OS : P = 0.004 ) as individual prognostic markers for DFS and OS .
RESULTS	The following prognostic subgroups were identified : good ( low DNA Index + G1/2 tumor grading ) , intermediate ( low DNA Index + G3 tumor grading or high DNA Index + G1/2 tumor grading ) , poor ( high DNA Index + G3 tumor grading ) .
CONCLUSIONS	The DNA index/tumor grading constellation may serve as a helpful guide for personalized treatment recommendations for adjuvant therapy of patients with pancreatic adenocarcinoma .

###24511726
BACKGROUND	Lung cancer has high mortality rates , with up to 90 % of patients dying within one to two years of its onset .
BACKGROUND	It is essential to carry out research to attempt to solve the problems .
BACKGROUND	Most patients suffer serious fatigue resulting from various symptoms and its long-term treatment .
BACKGROUND	Furthermore , the other related complications such as underlying disease , anemia , malnutrition , nausea , and vomiting can reduced tolerance of chemotherapy .
BACKGROUND	Study showed that nurses are the only hospital staff involved in managing fatigue .
BACKGROUND	As it remains unclear to how fatigue should be managed , it is important to devise a strategy for providing a better service to help these patients survive longer .
OBJECTIVE	To examine fatigue scores in patients with lung cancer after chemotherapy treatment , and to compare the scores of the group receiving the multidisciplinary education program in self-care group with those of the control group .
METHODS	A randomized controlled trial was conducted in two groups .
METHODS	The control group and the trial group were 30 patients in each .
METHODS	Studied aged from 45 to 65 years old who were receiving chemotherapy at the Chemotherapy Unit in the Out-Patients Department , Rajavithi Hospital .
METHODS	For a nine-week period , the control group received the hospital 's normal care program while the trial group received the multidisciplinary education program in self-care on fatigue .
METHODS	Scores were allocated to each individual to reflect their levels of fatigue , nutrition , physical fitness , and depression , compared using Independent t-test , Fisher exact test , and Mann-Whitney U-test .
RESULTS	Sixty patients were enrolled into the study ( mean age = 56.10 ( 45-65 ) , male = 68.33 % ) .
RESULTS	The basic characteristics of each individual were not significantly different between the two groups .
RESULTS	The mean ( + / - SD ) fatigue scores were 2.98 + / - 1.96 and 3.99 + / - 1.64 for the control and the trial group respectively , and these figures were statistically significant ( p = 0.036 ) .
RESULTS	Nutrition scores were significantly higher in the trial group than in the control group ( p = 0.002 ) , but the other scores weight , albumin , physical fitness , and depression were not significantly different between the two groups .
CONCLUSIONS	The multidisciplinary education program in self-care results in decreased fatigue in patients with lung cancer who are receiving chemotherapy .
CONCLUSIONS	Therefore , it is recommended that more health professionals and specialists participate actively inpatient care to respond directly to patients ' needs .
CONCLUSIONS	This strategy should be adopted as the standard guideline for caring for patients with cancer who are receiving chemotherapy , and for patients with other conditions .

###25424121
BACKGROUND	The present study aimed to determine that whether L-carnitine infusion could ameliorate fasting-induced adverse effects and improve outcomes .
METHODS	In this 7-day , randomized , single-blind , placebo-controlled , pilot study , 15 metabolic syndrome ( MetS ) patients ( 11/4 F/M ; age 46.9 9.14 years ; body mass index [ BMI ] 28.2 1.8 kg/m2 ) were in the L-carnitine group ( LC ) and 15 ( 10/5 F/M ; age 46.8 10.9 years ; BMI 27.1 2.3 kg/m2 ) were in the control group ( CT ) .
METHODS	All participants underwent a 5-day modified fasting therapy introduced with 2-day moderate calorie restriction .
METHODS	Patients in the LC group received 4 g/day of intravenous L-carnitine , while patients in the CT group were injected with saline .
METHODS	Blood pressure ( BP ) , anthropometric characteristics , markers of liver function , metabolic indices ( plasma glucose , lipid profiles , uric acid , free fatty acid and insulin ) and hypersensitivity C-reactive protein were measured .
METHODS	Perceived hunger was recorded daily by self-rating visual analogue scales .
METHODS	Fatigue was evaluated by Wessely and Powell scores .
RESULTS	In contrast to the CT group , total cholesterol , alanine aminotransferase , systolic and diastolic BP did not change significantly in the LC group after prolonged fasting .
RESULTS	There were significant differences in weight loss ( LC -4.6 0.9 vs. CT -3.2 1.1 kg , P = 0.03 ) , and waist circumference ( LC -5.0 2.2 vs. CT -1.7 1.16 cm , P < 0.001 ) , waist hip ratio ( LC -0.023 0.017 vs. CT 0.012 0.01 , P < 0.001 ) , insulin concentration ( LC -9.9 3.58 vs. CT -6.32 3.44 U/mL , P = 0.046 ) , and - glutamyltransferase concentration ( LC -7.07 6.82 vs. CT -2.07 4.18 , P = 0.024 ) .
RESULTS	Perceived hunger scores were significantly increased ( P < 0.05 ) in the CT group during starvation , which was alleviated with L-carnitine administration in the LC group .
RESULTS	Physical fatigue ( LC -3.2 3.17 vs. CT 1.8 2.04 , P < 0.001 ) and fatigue severity ( LC -11.6 8.38 vs. CT 8.18 7.32 , P < 0.001 ) were significantly reduced in the LC group but were aggravated in the CT group .
CONCLUSIONS	Intravenous L-carnitine can ameliorate fasting-induced hunger , fatigue , cholesterol abnormalities and hepatic metabolic changes and facilitate fasting-induced weight loss in MetS patients .
BACKGROUND	ChiCTR-TNRC-12002835 .

###24864182
OBJECTIVE	Caustic substance ingestion in childhood is a public health issue in developing countries , and several management protocols have been proposed to prevent the resulting esophageal strictures .
OBJECTIVE	The role of corticosteroids in preventing corrosive-induced strictures is controversial .
OBJECTIVE	Our aim was to study the influence of high doses of corticosteroids in preventing esophageal strictures .
METHODS	Eighty-three children with a mean age of 4.10 6 2.63 years and with grade IIb esophageal burns ( an esophagogastroscopy was performed within 2448 hours of injury ) due to corrosive substance ingestion were enrolled in our study between 2005 and 2008 .
METHODS	Forty-two children ( study group ) received methylprednisolone ( 1 g/1 .73 m2 per day for 3 days ) , ranitidine , ceftriaxone , and total parenteral nutrition .
METHODS	Forty-one children ( control group ) were administered the same regimen excluding methylprednisolone .
METHODS	Stricture development was compared between groups based on endoscopic and radiologic findings .
RESULTS	During the endoscopic examination , stricture development was observed in 4 patients ( 10.8 % ) in the study group and in 12 patients ( 30 % ) in the control group .
RESULTS	The difference was statistically significant ( P = .038 ) .
RESULTS	The stricture development rate in the upper gastrointestinal system with barium meal was 14.3 % and 45.0 % in the study and control groups , respectively .
RESULTS	The difference was statistically significant ( P = .004 ) .
RESULTS	The duration of total parenteral nutrition was shorter in the study group compared with the control group ( P = .001 ) .
RESULTS	High doses of methylprednisolone were well tolerated in the study group without any side effects .
CONCLUSIONS	High doses of methylprednisolone used for the management of grade IIb esophageal burns may reduce stricture development .

###26427112
OBJECTIVE	To study the protective effects of Dongchongxiacao ( Cordyceps ) ( DCXC ) on contrast-induced nephropathy ( CIN ) in patients with type 2 diabetes and renal insufficiency undergoing coronary angiography .
METHODS	A total of 120 patients with type 2 diabetes whose estimated glomerular filtration rater ( eGFR ) was 60 mL/min 1.73 in2 , were divided randomly into three groups , basic treatment group ( n = 41 ) , standard DCXC therapy group ( n = 39 , 2-g corbrin capsules , 3 times/d , 3 days before and after angiography ) , and intensive DCXC therapy group ( n = 40 , 3-g corbrin capsules , 3 times/d , 3 days before and after angiography ) .
METHODS	Serum creatinine ( cr ) and eGFR were assessed at the time of admission to hospital , and on days 1 , 2 and 3 after angiography .
METHODS	Urine neutrophil-gelatinase-associated-lipo - calin ( NGAL ) , kidney injury molecule-1 ( KIM-1 ) and interleukin-18 ( IL-18 ) were measured before angiography and at day 1 after angiography for all patients .
METHODS	The primary end point was the prevalence of CIN .
METHODS	The secondary end point was a 25 % or greater reduction in eGFR .
RESULTS	CIN occurred in 11 of 120 patients ( 9.17 % ) .
RESULTS	The prevalence of CIN was lower in the DCXC treatment groups than in the basic treatment group ( P < 0.05 ) , with a more significant decrease in the prevalence of CIN in the intensive DCXC therapy group ( P < 0.01 ) .
RESULTS	Compared with the basic treatment group , a lower proportion of patients in the DCXC treatment groups had an eGFR decrease of 25 % or greater ( P < 0.05 ) ; patients with an eGFR decrease of 25 % or greater accounted for an even lower proportion in the intensive DCXC therapy group ( P < 0.01 ) .
RESULTS	Within 1 day of the procedure , urine levels of KIM-1 , NGAL and IL-18 in patients in the intensive DCXC therapy group were lower than those in the basic treatment group and standard therapy group ( P < 0.05 ) .
CONCLUSIONS	DCXC treatment may protect against CIN in patients with type 2 diabetes and renal insufficiency undergoing coronary angiography , with intensive DCXC therapy being more effective .

###25042661
BACKGROUND	Carotid intima-media thickness ( CIMT ) is a marker for atherosclerosis .
BACKGROUND	Adult post-coarctectomy patients ( CoA ) demonstrate an increased cardiovascular risk and increased CIMT compared to controls .
BACKGROUND	This study evaluates the effect of high dose statins on the change in CIMT and cardiovascular risk .
METHODS	We designed a multicenter , prospective , randomized , open label trial with blinded endpoint ( PROBE design ) to evaluate the effect of three year treatment with atorvastatin 80 mg on CIMT and cardiovascular risk .
METHODS	Primary endpoint was CIMT measured by B mode ultrasonography .
METHODS	Secondary endpoints were mortality and morbidity due to cardiovascular disease and serum lipids .
RESULTS	155 patients ( 36.3 11.8 years , 96 ( 62 % ) male ) were randomized ( atorvastatin = 80 , no treatment = 75 ) .
RESULTS	There was no significant effect of atorvastatin on the change in CIMT ( treatment effect -0.005 , 95 % CI , -0.039 -0.029 ; P = 0.76 ) .
RESULTS	A significant effect on serum cholesterol and LDL levels was found ( - 0.71 , 95 % CI , - 1.16 to - 0.26 ; P = 0.002 vs - 0.66 , 95 % CI - 1.06 to - 0.26 ; P = 0.001 ) .
RESULTS	There was no difference in secondary outcome measures .
RESULTS	Baseline CIMT was higher in hypertensive compared to normotensive CoA .
RESULTS	( 0.69 0.16 mm vs 0.61 0.98 mm ; P = 0.002 ) .
RESULTS	Hypertension ( = 0.043 , P = 0.031 ) was the strongest determinant CIMT .
CONCLUSIONS	Three year treatment with atorvastatin does not lead to a reduction of CIMT and secondary outcome measures , despite a decrease in total cholesterol and LDL levels .
CONCLUSIONS	Hypertensive CoA demonstrate the highest CIMT and the largest CIMT progression .
CONCLUSIONS	Blood pressure control should be the main focus in CoA to decrease cardiovascular risk .

###25391196
BACKGROUND	The problem of image quality in a large number of upper airway obstructed patients is the superimposition of the airway over the bone of the spine on the AP view .
BACKGROUND	This problem was resolved by increasing KVp to high KVp technique and adding extra radiographic filters ( copper filter ) to reduce the sharpness of the bone and increase the clarity of the airway .
BACKGROUND	However , this raises a concern that patients might be receiving an unnecessarily higher dose of radiation , as well as the effectiveness of the invented filter compared to the traditional filter .
OBJECTIVE	To evaluate the level of radiation dose that patients receive with the use of multi-layer filter compared to non-filter and to evaluate the image quality of the upper airways between using the radiographic filter ( multi-layer filter ) and the traditional filter ( copperfilter ) .
METHODS	The attenuation curve of both filter materials was first identified .
METHODS	Then , both the filters were tested with Alderson Rando phantom to determine the appropriate exposure .
METHODS	Using the method described , a new type of filter called the multi-layer filter for imaging patients was developed .
METHODS	A randomized control trial was then performed to compare the effectiveness of the newly developed multi-layer filter to the copper filter .
METHODS	The research was conducted in patients with upper airway obstruction treated at Queen Sirikit National Institute of Child Health from October 2006 to September 2007 .
METHODS	A total of 132 patients were divided into two groups .
METHODS	The experimental group used high kVp technique with multi-layer filter , while the control group used copper filter .
METHODS	A comparison of film interpretation between the multi-layer filter and the copper filter was made by a number of radiologists who were blinded to both to the technique and type of filter used .
RESULTS	Patients had less radiation from undergoing the kVp technique with copper filter and multi-layer filter compared to the conventional technique , where no filter is used .
RESULTS	Patients received approximately 65.5 % less radiation dose using high kVp technique with multi-layer filter compared to the conventional technique , and 25.9 % less than using the traditional copper filter 45 % of the radiologists who participated in this study reported that the high kVp technique with multi-layer filter was better for diagnosing stenosis , or narrowing of the upper airways .
RESULTS	33 % reported that , both techniques were equal , while 22 % reported that the traditional copper filter allowed for better details of airway obstruction .
RESULTS	These findings showed that the multi-layered filter was comparable to the copper filter in terms of film interpretation .
CONCLUSIONS	Using the multi-layer filter resulted in patients receiving a lower dose of radiation , as well as similar film interpretation when compared to the traditional copper filter .

###24419112
OBJECTIVE	The objective of this study was to test the efficacy of cognitive-behavioral therapy plus hypnosis ( CBTH ) to control fatigue in patients with breast cancer undergoing radiotherapy .
OBJECTIVE	We hypothesized that patients in the CBTH group receiving radiotherapy would have lower levels of fatigue than patients in an attention control group .
METHODS	Patients ( n = 200 ) were randomly assigned to either the CBTH ( n = 100 ; mean age , 55.59 years ) or attention control ( n = 100 ; mean age , 55.97 years ) group .
METHODS	Fatigue was measured at four time points ( baseline , end of radiotherapy , 4 weeks , and 6 months after radiotherapy ) .
METHODS	Fatigue was measured using the Functional Assessment of Chronic Illness Therapy ( FACIT ) - Fatigue subscale and Visual Analog Scales ( VASs ; Fatigue and Muscle Weakness ) .
RESULTS	The CBTH group had significantly lower levels of fatigue ( FACIT ) at the end of radiotherapy ( z , 6.73 ; P < .001 ) , 4-week follow-up ( z , 6.98 ; P < .001 ) , and 6-month follow-up ( z , 7.99 ; P < .001 ) assessments .
RESULTS	Fatigue VAS scores were significantly lower in the CBTH group at the end of treatment ( z , 5.81 ; P < .001 ) and at the 6-month follow-up ( z , 4.56 ; P < .001 ) , but not at the 4-week follow-up ( P < .07 ) .
RESULTS	Muscle Weakness VAS scores were significantly lower in the CBTH group at the end of treatment ( z , 9.30 ; P < .001 ) and at the 6-month follow-up ( z , 3.10 ; P < .02 ) , but not at the 4-week follow-up ( P < .13 ) .
CONCLUSIONS	The results support CBTH as an evidence-based intervention to control fatigue in patients undergoing radiotherapy for breast cancer .
CONCLUSIONS	CBTH is noninvasive , has no adverse effects , and its beneficial effects persist long after the last intervention session .
CONCLUSIONS	CBTH seems to be a candidate for future dissemination and implementation .

###24846909
BACKGROUND	The use of mobile phone technologies for health promotion and disease prevention has advanced rapidly in recent years .
BACKGROUND	Text4baby is a theory-based mobile health ( mHealth ) program in which text messages are delivered to pregnant women and new mothers to improve their health care beliefs and behaviors and improve health status and clinical outcomes .
BACKGROUND	Recent evaluations of Text4baby have found that it improves targeted health attitudes and beliefs , but effects on behavior have not yet been determined .
OBJECTIVE	In this study , investigators aimed to evaluate Text4baby in the military women 's population .
METHODS	Investigators conducted a randomized controlled trial at Madigan Army Medical Center in Tacoma , Washington , from December 2011 through September 2013 .
METHODS	All participants were pregnant women first presenting for care at Madigan .
METHODS	Investigators conducted a baseline assessment using a 24-item , self-administered online survey of attitudes and behaviors related to Text4baby message content .
METHODS	Participants were randomized to Text4baby plus usual care ( intervention ) or usual care alone ( control ) .
METHODS	Investigators analyzed treatment effects of Text4baby on short-term targeted outcomes 4 weeks post enrollment .
RESULTS	For this study , 943 patients were randomized and completed a baseline assessment .
RESULTS	The average patient age was 28 years and nearly 70 % self-identified as Caucasian .
RESULTS	48.7 % of enrollees ( 459/943 ) completed the first follow-up assessment .
RESULTS	Higher rates of single and working/in-school patients dropped out of the intervention arm of the study , and we adjusted for this finding in subsequent models .
RESULTS	However , while investigators were unable to re-survey these participants , only 1.9 % of Text4baby enrollees ( 18/943 ) dropped the service during the study period .
RESULTS	Adjusted and unadjusted logistic generalized estimating equation models were developed to assess intervention effects on measured outcomes .
RESULTS	In the model adjusting for age , marital status , having had a previous baby , and race/ethnicity , there was a significant effect of Text4baby intervention exposure on increased agreement with belief in the importance of taking prenatal vitamins ( OR 1.91 , 95 % CI 1.08-3 .34 , P = .024 ) .
RESULTS	All of these attitudes had been targeted by at least one text message during the 4-week evaluation period examined in this study .
RESULTS	In unadjusted models , there was a significant effect of intervention exposure on belief in the importance of visiting a health care provider to be a healthy new mother ( OR 1.52 , 95 % CI 1.01-2 .31 , P = .046 ) and in the health risks of alcohol during pregnancy ( OR 2.06 , 95 % CI 1.00-4 .31 , P = .05 ) .
RESULTS	No behavioral effects of the intervention were observed in this analysis .
CONCLUSIONS	Text4baby is a promising program that offers lessons for future mHealth activities .
CONCLUSIONS	This large-scale study demonstrated initial effects of the program on attitudes and beliefs targeted by the messages received by women during the study period .
CONCLUSIONS	Results confirm previous findings from Text4baby studies and other mHealth research .
CONCLUSIONS	Future analyses will examine dosage effects of the intervention on behaviors and clinical outcomes .

###24382719
BACKGROUND	The influence of rehabilitation on the outcomes after arthroscopic rotator cuff repair remains unknown .
BACKGROUND	The purpose of this study was to compare clinical results and tendon healing rates following arthroscopic rotator cuff repair utilizing two distinct rehabilitation protocols .
METHODS	Over a thirty-month period , 124 patients under the age of sixty-five years underwent arthroscopic repair of a full-thickness rotator cuff tear measuring < 30 mm in width .
METHODS	Postoperatively , patients were randomized either to a traditional rehabilitation program with early range of motion or to an immobilization group with delayed range of motion for six weeks .
METHODS	Clinical outcomes assessment included visual analog pain scale score , American Shoulder and Elbow Surgeons ( ASES ) score , Simple Shoulder Test ( SST ) , relative Constant score , and strength measurements at six , twelve , and twenty-four months .
METHODS	Tendon integrity was assessed with ultrasonography at a minimum of twelve months postoperatively .
RESULTS	There were no significant differences in patient age , tear size , or measures of preoperative function between groups at baseline .
RESULTS	Final clinical follow-up was available for 114 subjects ( 92 % ) .
RESULTS	Active elevation and external rotation were better in the traditional rehabilitation group at three months .
RESULTS	No significant differences were seen in functional scores , active motion , and shoulder strength between rehabilitation groups at later time points .
RESULTS	Functional outcomes plateaued at six or twelve months except for the relative Constant score , which improved up to twenty-four months following surgery .
RESULTS	Ninety-two percent of the tears were healed , with no difference between rehabilitation protocols ( p = 0.46 ) .
CONCLUSIONS	Arthroscopic repair of small and medium full-thickness rotator cuff tears results in reliable improvements in clinical outcomes and a high rate of tendon integrity using a double-row repair technique in patients under the age of sixty-five years .
CONCLUSIONS	There is no apparent advantage or disadvantage of early passive range of motion compared with immobilization with regard to healing or functional outcome .

###25332327
BACKGROUND	Micronutrients play an important role in immune function .
BACKGROUND	To our knowledge , there have been no comprehensive studies on the role of micronutrient supplementation in children with tuberculosis .
OBJECTIVE	We assessed the effect of micronutrient supplementation in children treated with antituberculosis therapy ( ATT ) .
METHODS	A randomized , double-blind , placebo-controlled trial that used a 2 2 factorial design was undertaken at 2 teaching hospitals in Delhi .
METHODS	Children with newly diagnosed intrathoracic tuberculosis were enrolled , and they received ATT together with daily supplementation for 6 mo with either zinc alone , micronutrients without zinc , micronutrients in combination with zinc , or a placebo .
METHODS	Main outcomes were weight gain and an improvement in a chest X-ray ( CXR ) lesion assessed at 6 mo of treatment .
RESULTS	A total of 403 children were enrolled and randomly assigned .
RESULTS	A microbiological diagnosis of tuberculosis was confirmed in 179 children ( 44.4 % ) .
RESULTS	The median ( 95 % CI ) increase in weight-for-age z score at 6 mo was not significantly different between subjects who received micronutrients [ 0.75 ( 0.66 , 0.84 ) ] and those who did not receive micronutrients [ 0.76 ( 0.67 , 0.85 ) ] and between subjects who received zinc [ 0.76 ( 0.68 , 0.85 ) ] and those who did not receive zinc [ 0.75 ( 0.66 , 0.83 ) ] .
RESULTS	An improvement in CXR was observed in 285 children , but there was no difference between those receiving zinc and no zinc or between those receiving micronutrients and no micronutrients after 6 mo of ATT .
RESULTS	However , children who received micronutrients had a faster gain in height over 6 mo than did those who did not receive micronutrients ( height-for-age z score = 0.08 ; P = 0.014 ) .
CONCLUSIONS	Micronutrient supplementation did not modify the weight gain or clearance of lesions on CXR in children with intrathoracic tuberculosis .
CONCLUSIONS	However , micronutrient supplementation during treatment may improve height gain in children with intrathoracic tuberculosis .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT00801606 .

###24862395
OBJECTIVE	To modify the Prostate Cancer Prevention Trial risk calculator ( PCPTRC ) to predict low - vs high-grade ( Gleason grade7 ) prostate cancer and incorporate percent free-prostate-specific antigen ( PSA ) .
METHODS	Data from 6664 Prostate Cancer Prevention Trial placebo arm biopsies ( 5826 individuals ) , where prostate-specific antigen and digital rectal examination results were available within 1 year before the biopsy and PSA was 10 ng/mL , were used to develop a nominal logistic regression model to predict the risk of no vs low-grade ( Gleason grade < 7 ) vs high-grade cancer ( Gleason grade7 ) .
METHODS	Percent free-PSA was incorporated into the model based on likelihood ratio analysis of a San Antonio Biomarkers of Risk cohort .
METHODS	Models were externally validated on 10 Prostate Biopsy Collaborative Group cohorts and 1 Early Detection Research Network reference set .
RESULTS	Of all the Prostate Cancer Prevention Trial biopsies , 5468 ( 82.1 % ) were negative for prostate cancer , 942 ( 14.1 % ) detected low-grade , and 254 ( 3.8 % ) detected high-grade disease .
RESULTS	Significant predictors were ( log base 2 ) PSA ( odds ratio for low-grade vs no cancer , 1.29 * ; high-grade vs no cancer , 2.02 * ; high-grade vs low-grade cancer , 1.57 * ) , digital rectal examination ( 0.96 , 1.49 * , 1.55 * , respectively ) , age ( 1.02 * , 1.05 * , 1.03 * , respectively ) , African American race ( 1.13 , 2.83 * , 2.51 * , respectively ) , prior biopsy ( 0.63 * , 0.81 , 1.27 , respectively ) , and family history ( 1.31 * , 1.25 , 0.95 , respectively ) , where * indicates P value < .05 .
RESULTS	The new PCPTRC 2.0 either with or without percent free-PSA ( also significant by the likelihood ratio method ) validated well externally .
CONCLUSIONS	By differentiating the risk of low - vs high-grade disease on biopsy , PCPTRC 2.0 better enables physician-patient counseling concerning whether to proceed to biopsy .

###24450858
BACKGROUND	Phosphatidylinositol-3-kinase delta ( PI3K ) mediates B-cell receptor signaling and microenvironmental support signals that promote the growth and survival of malignant B lymphocytes .
BACKGROUND	In a phase 1 study , idelalisib , an orally active selective PI3K inhibitor , showed antitumor activity in patients with previously treated indolent non-Hodgkin 's lymphomas .
METHODS	In this single-group , open-label , phase 2 study , 125 patients with indolent non-Hodgkin 's lymphomas who had not had a response to rituximab and an alkylating agent or had had a relapse within 6 months after receipt of those therapies were administered idelalisib , 150 mg twice daily , until the disease progressed or the patient withdrew from the study .
METHODS	The primary end point was the overall rate of response ; secondary end points included the duration of response , progression-free survival , and safety .
RESULTS	The median age of the patients was 64 years ( range , 33 to 87 ) ; patients had received a median of four prior therapies ( range , 2 to 12 ) .
RESULTS	Subtypes of indolent non-Hodgkin 's lymphoma included follicular lymphoma ( 72 patients ) , small lymphocytic lymphoma ( 28 ) , marginal-zone lymphoma ( 15 ) , and lymphoplasmacytic lymphoma with or without Waldenstrm 's macroglobulinemia ( 10 ) .
RESULTS	The response rate was 57 % ( 71 of 125 patients ) , with 6 % meeting the criteria for a complete response .
RESULTS	The median time to a response was 1.9 months , the median duration of response was 12.5 months , and the median progression-free survival was 11 months .
RESULTS	Similar response rates were observed across all subtypes of indolent non-Hodgkin 's lymphoma , though the numbers were small for some categories .
RESULTS	The most common adverse events of grade 3 or higher were neutropenia ( in 27 % of the patients ) , elevations in aminotransferase levels ( in 13 % ) , diarrhea ( in 13 % ) , and pneumonia ( in 7 % ) .
CONCLUSIONS	In this single-group study , idelalisib showed antitumor activity with an acceptable safety profile in patients with indolent non-Hodgkin 's lymphoma who had received extensive prior treatment .
CONCLUSIONS	( Funded by Gilead Sciences and others ; ClinicalTrials.gov number , NCT01282424 . )

###25371077
BACKGROUND	PRONOUNCE compared the efficacy and safety of pemetrexed + carboplatin followed by pemetrexed ( Pem + Cb ) with paclitaxel + carboplatin + bevacizumab followed by bevacizumab ( Pac + Cb + Bev ) in patients with advanced nonsquamous non-small-cell lung cancer ( NSCLC ) .
METHODS	Patients 18 years of age with stage IV nonsquamous NSCLC ( American Joint Committee on Cancer v7 .0 ) , and Eastern Cooperative Oncology Group performance status 0/1 were randomized ( 1:1 ) to four cycles of induction Pem + Cb ( pemetrexed , 500 mg/m , carboplatin , area under the curve = 6 ) followed by Pem maintenance or Pac + Cb + Bev ( paclitaxel , 200 mg/m , carboplatin , area under the curve = 6 , and bevacizumab , 15 mg/kg ) followed by Bev maintenance in the absence of progressive disease or discontinuation .
METHODS	The primary objective was progression-free survival ( PFS ) without grade 4 toxicity ( G4PFS ) .
METHODS	Secondary end points were PFS , overall survival ( OS ) , overall response rate ( ORR ) , disease control rate ( DCR ) , and safety .
METHODS	Resource utilization was also assessed .
RESULTS	Baseline characteristics of the patients randomized to Pem + Cb ( N = 182 ) and Pac + Cb + Bev ( N = 179 ) were well balanced between the arms .
RESULTS	Median ( months ) G4PFS was 3.91 for Pem + Cb and 2.86 for Pac + Cb + Bev ( hazard ratio = 0.85 , 90 % confidence interval , 0.7-1 .04 ; p = 0.176 ) ; PFS , OS , ORR , or DCR did not differ significantly between the arms .
RESULTS	Significantly more drug-related grade 3/4 anemia ( 18.7 % versus 5.4 % ) and thrombocytopenia ( 24.0 % versus 9.6 % ) were reported for Pem + Cb .
RESULTS	Significantly more grade 3/4 neutropenia ( 48.8 % versus 24.6 % ) , grade 1/2 alopecia ( 28.3 % versus 8.2 % ) , and grade 1/2 sensory neuropathy were reported for Pac + Cb + Bev .
RESULTS	Number of hospitalizations and overall length of stay did not differ significantly between the arms .
CONCLUSIONS	Pem + Cb did not produce significantly better G4PFS compared with Pac + Cb + Bev .
CONCLUSIONS	Pem + Cb was not superior in PFS , OS , ORR , or DCR compared with Pac + Cb + Bev .
CONCLUSIONS	Both regimens were well tolerated , although , toxicity profiles differed .

###24336837
BACKGROUND	Hamstring injuries are the most common muscle injury in male amateur soccer players and have a high rate of recurrence , often despite extensive treatment and long rehabilitation periods .
BACKGROUND	Eccentric strength and flexibility are recognised as important modifiable risk factors , which have led to the development of eccentric hamstring exercises , such as the Nordic hamstring exercise .
BACKGROUND	As the effectiveness of the Nordic hamstring exercise in reducing hamstring injuries has never been investigated in amateur soccer players , the aim of this study is to investigate the effect of this exercise on the incidence and severity of hamstring injuries in male amateur soccer players .
BACKGROUND	An additional aim is to determine whether flexibility is associated with hamstring injuries .
METHODS	Cluster-randomised controlled trial with soccer teams as the unit of cluster .
METHODS	Dutch male amateur soccer players , aged 18-40years , were allocated to an intervention or control group .
METHODS	Both study groups continued regular soccer training during 2013 , but the intervention group additionally performed the Nordic hamstring exercise ( 25 sessions over 13weeks ) .
METHODS	Primary outcomes are the incidence of initial and recurrent hamstring injury and injury severity .
METHODS	Secondary outcomes are hamstring-and-lower-back flexibility and compliance .
METHODS	Compliance to the intervention protocol was also monitored .
CONCLUSIONS	Eccentric hamstring strength exercises are hypothesised to reduce the incidence of hamstring injury among male amateur soccer players by 70 % .
CONCLUSIONS	The prevention of such injuries will be beneficial to soccer players , clubs , football associations , health insurance companies and society .
BACKGROUND	NTR3664 .

###24630751
OBJECTIVE	To evaluate computed tomography ( CT ) perfusion for assessment of early treatment response after transarterial radioembolization of patients with liver malignancy .
METHODS	Dynamic contrast-enhanced CT liver perfusion was performed before and 4 weeks after transarterial radioembolization in 40 patients ( 25 men and 15 women ; mean age , 64 y 11 ; range , 35-80 y ) with liver metastases ( n = 27 ) or hepatocellular carcinoma ( HCC ) ( n = 13 ) .
METHODS	Arterial perfusion ( AP ) of tumors derived from CT perfusion and tumor diameters were measured on CT perfusion before and after transarterial radioembolization .
METHODS	Success of transarterial radioembolization was evaluated on morphologic follow-up imaging ( median follow-up time , 4 mo ) based on Response Evaluation Criteria in Solid Tumors ( Version 1.1 ) .
METHODS	CT perfusion parameters before and after transarterial radioembolization for different response groups were compared .
METHODS	Kaplan-Meier curves were plotted to illustrate overall 1-year survival rates .
RESULTS	Liver metastases showed significant differences in AP before and after transarterial radioembolization in responders ( P < .05 ) but not in nonresponders ( P = .164 ) .
RESULTS	In HCC , AP values before and after transarterial radioembolization were not significantly different in responders and nonresponders ( P = .180 and P = .052 ) .
RESULTS	Tumor diameters were not significantly different on CT perfusion before and after transarterial radioembolization in responders and nonresponders with liver metastases and HCC ( P = .654 , P = .968 , P = .148 , P = .164 ) .
RESULTS	In patients with significant decrease of AP in liver metastases after transarterial radioembolization , 1-year overall survival was significantly higher than in patients showing no reduction of AP .
CONCLUSIONS	CT perfusion showed early reduction of AP in liver metastases responding to transarterial radioembolization ; tumor diameter remained unchanged early after treatment .
CONCLUSIONS	No significant early treatment response to transarterial radioembolization was found in patients with HCC .
CONCLUSIONS	In patients with liver metastases , a decrease of AP after transarterial radioembolization was associated with a higher 1-year overall survival rate .

###25824259
OBJECTIVE	To assess the intraocular penetration of 0.5 % moxifloxacin hydrochloride into aqueous humour after oral and topical administration .
METHODS	A prospective , interventional study of 42 patients scheduled to undergo cataract surgery was carried out .
METHODS	Out of the 42 subjects , 21 were randomly categorised into Group I and received one drop of 0.5 % topical moxifloxacin four times , at 15min intervals starting 75min before the surgery .
METHODS	Another 21 subjects were categorised into Group II and all subjects in this group were administered a single tablet of 400mg of moxifloxacin , 12h before the surgery .
METHODS	Estimation of moxifloxacin in aqueous samples was carried out using high-performance liquid chromatography .
METHODS	Results were analysed using Student unpaired ` t ' test and analysis of variance .
METHODS	The value of p < 0.05 was considered to be significant .
RESULTS	Mean aqueous concentration of moxifloxacin attained in the oral group ( n = 21 ) was 0.5040.30 g/mL while that in the topical group ( n = 21 ) was 2.040.72 g/mL , and this difference in levels was statistically significant ( p < 0.005 ) .
RESULTS	The levels attained by both the groups well exceeded the MIC90 ( minimum inhibitory concentration of antibiotic required to inhibit growth of 90 % of bacteria strains ) levels for most of the organisms causing endophthalmitis .
RESULTS	Penetration of moxifloxacin in aqueous in both the groups was not affected by gender , intraocular pressure or comorbidities significantly .
RESULTS	However , aqueous levels were found to be higher among the younger subjects within the topical group .
CONCLUSIONS	Moxifloxacin has an impressive spectrum of coverage and this pharmacokinetic study reinforces its potential as a prophylactic drug against intraocular infections , given the high aqueous levels post topical administration .

###25365892
OBJECTIVE	To evaluate the postoperative analgesic effect and postoperative nausea and vomiting ( PONV ) after using epidural low-dose morphine-soaked microfibrillar collagen sponge ( MMCS ) , as compared with placebo .
METHODS	A prospective randomized double-blind placebo-controlled study was performed on patients under-going single-level posterior lumbar spinal decompression and instrumented fusion at the Department of Orthopedic Surgery , Siriraj Hospital , between August 2012 and December 2013 .
METHODS	Patients were randomly allocated into two groups to receive either an epidural MMCS or an epidural normal saline-soaked microfibrillar collagen sponge ( placebo ) .
METHODS	Intensity ofpain , PONV and total amount of morphine were recorded at 4 , 24 , 48 , and 72 hours , postoperatively .
RESULTS	The analgesic effect was enhanced significantly in the epidural MMCS group , as the amount ofmorphine used was statistically less than in the placebo group at 4 and 24 hours ( p < 0.05 ) .
CONCLUSIONS	A single low-dose epidural MMCS is effectiveforpain control after posterior lumbar spinal surgery with a low incidence of PONV .

###24935221
BACKGROUND	Massive resources are expended every year on cross-cultural communication training for physicians .
BACKGROUND	Such training is a focus of continuing medical education nationwide and is part of the curriculum of virtually every medical school in America .
BACKGROUND	There is a pressing need for evidence regarding the effects on patients of cross-cultural communication training for physicians .
BACKGROUND	There is a need to understand the added benefit of such training compared to more general communication .
BACKGROUND	We know of no rigorous study that has assessed whether cross-cultural communication training for physicians results in better health outcomes for their patients .
BACKGROUND	The current study aims to answer this question by enhancing the Physician Asthma Care Education ( PACE ) program to cross cultural communication ( PACE Plus ) , and comparing the effect of the enhanced program to PACE on the health outcomes of African American and Latino/Hispanic children with asthma .
METHODS	A three-arm randomized control trial is used to compare PACE Plus , PACE , and usual care .
METHODS	Both PACE and PACE Plus are delivered in two , two-hour sessions over a period of two weeks to 5-10 primary care physicians who treat African American and Latino/Hispanic children with asthma .
METHODS	One hundred twelve physicians and 1060 of their pediatric patients were recruited who self-identify as African American or Latino/Hispanic and experience persistent asthma .
METHODS	Physicians were randomized into receiving either the PACE Plus or PACE intervention or into the control group .
METHODS	The comparative effectiveness of PACE and PACE Plus on clinician 's therapeutic and communication practices with the family/patient , children 's urgent care use for asthma , asthma control , and quality of life , and parent/caretaker satisfaction with physician performance will be assessed .
METHODS	Data are collected via telephone survey and medical record review at baseline , 9 months following the intervention , and 21 months following the intervention .
CONCLUSIONS	This study aims to reduce disparities in asthma outcomes among African American and Latino/Hispanic children through cross-cultural communication training of their physicians and assessing the added value of this training compared to general communication .
CONCLUSIONS	The results of this study will provide important information about the value of cross-cultural training in helping to address persistent racial disparities in outcomes .
BACKGROUND	ClinicalTrials.gov : NCT01251523 December 1 , 2010 .

###25165394
BACKGROUND	Isothiocyanates in cruciferous vegetables modulate signaling pathways critical to carcinogenesis , including nuclear factor kappa-light-chain-enhancer of activated B cells ( NF-B ) , a central regulator of inflammation .
BACKGROUND	Glutathione S-transferase ( GST ) M1 and GSTT1 metabolize isothiocyanates ; genetic variants may result in differences in biologic response .
OBJECTIVE	The objective of this study was to test whether consumption of cruciferous or cruciferous plus apiaceous vegetables altered serum concentrations of interleukin ( IL ) -6 , IL-8 , C-reactive protein ( CRP ) , tumor necrosis factor ( TNF ) , and soluble TNF receptor ( sTNFR ) I and II , and whether this response was GSTM1/GSTT1 genotype dependent .
METHODS	In a randomized crossover trial , healthy men ( n = 32 ) and women ( n = 31 ) aged 20-40 y consumed 4 14-d controlled diets : basal ( vegetable-free ) , single-dose cruciferous ( 1xC ) [ 7 g vegetables/kg body weight ( BW ) ] , double-dose cruciferous ( 2xC ) ( 14 g/kg BW ) , and cruciferous plus apiaceous ( carrot family ) ( 1xC + A ) vegetables ( 7 and 4 g/kg BW , respectively ) , with a 21-d washout period between each intervention .
METHODS	Urinary isothiocyanate excretion was also evaluated as a marker of systemic isothiocyanate exposure .
METHODS	Fasting morning blood and urine samples were collected on days 0 and 14 and analyzed .
RESULTS	IL-6 concentrations were significantly lower on day 14 of the 2xC and 1xC + A diets than with the basal diet [ -19 % ( 95 % CI : -30 % , -0.1 % ) and -20 % ( 95 % CI : -31 % , -0.7 % ) , respectively ] .
RESULTS	IL-8 concentrations were higher after the 1xC + A diet ( +16 % ; 95 % CI : 4.2 % , 35.2 % ) than after the basal diet .
RESULTS	There were no effects of diet on CRP , TNF - , or sTNFRI or II .
RESULTS	There were significant differences between GSTM1-null/GSTT1 + individuals for several biomarkers in response to 1xC + A compared with basal diets ( CRP : -37.8 % ; 95 % CI : -58.0 % , -7.4 % ; IL-6 : -48.6 % ; 95 % CI : -49.6 % , -12.0 % ; IL-8 : 16.3 % ; 95 % CI : 6.7 % , 57.7 % ) and with the 2xC diet compared with the basal diet ( IL-8 : -33.2 % ; 95 % CI : -43.0 % , -1.4 % ; sTNFRI : -7.5 % ; 95 % CI : -12.7 % , -2.3 % ) .
RESULTS	There were no significant reductions in biomarker concentrations in response to diet among GSTM1 + / GSTT1 + or GSTM1-null/GSTT1-null individuals .
RESULTS	Twenty-four-hour urinary isothiocyanate excretion was not associated with any of the inflammation markers overall ; however , IL-6 was inversely associated with total isothiocyanate excretion in GSTM1-null/GSTT1-null individuals ( = -0.12 ; 95 % CI : -0.19 , -0.05 ) .
CONCLUSIONS	In this young , healthy population , consumption of cruciferous and apiaceous vegetables reduced circulating IL-6 ; however , results for other biomarkers of inflammation were not consistent .

###25427568
BACKGROUND	Frailty is a highly prevalent condition in old age leading to vulnerability and greater risk of adverse health outcomes and disability .
BACKGROUND	Detecting and tackling frailty at an early stage can prevent disability .
BACKGROUND	The purpose of this study is to evaluate the effectiveness of a multifactorial intervention program to modify frailty parameters , muscle strength , and physical and cognitive performance in people aged 65 years or more .
BACKGROUND	It also assesses changes from baseline in falls , hospitalizations , nutritional risk , disability , institutionalization , and home-care .
METHODS	The current study is a randomised single-blind , parallel-group clinical trial , with a one and a half year follow-up , conducted in eight Primary Health Care Centres located in the city of Barcelona .
METHODS	Inclusion criteria are to be aged 65 years or older with positive frailty screening , timed get-up-and-go test between 10 to 30 seconds , and Cognition Mini-Exam ( MEC-35 ) of Lobo greater than or equal to 18 .
METHODS	A total of 352 patients have been equally divided into two groups : intervention and control .
METHODS	Sample size calculated to detect a 0.5 unit difference in the Short Physical Performance Battery ( Common SD : 1.42 , 20 % lost to follow-up ) .
METHODS	In the intervention group three different actions on frailty dimensions : rehabilitative therapy plus intake of hyperproteic nutritional shakes , memory workshop , and medication review are applied to sets of 16 patients .
METHODS	Participants in both intervention and control groups receive recommendations on nutrition , healthy lifestyles , and home risks.Evaluations are blinded and conducted at 0 , 3 , and 18 months .
METHODS	Intention to treat analyses will be performed .
METHODS	Multivariate analysis will be carried out to assess time changes of dependent variables .
CONCLUSIONS	It is expected that this study will provide evidence of the effectiveness of a multidisciplinary intervention on delaying the progression from frailty to disability in the elderly .
CONCLUSIONS	It will help improve the individual 's quality of life and also reduce the rates of falls , hospital admissions , and institutionalizations , thus making the health care system more efficient .
CONCLUSIONS	This preventive intervention can be adapted to diverse settings and be routinely included in Primary Care Centres as a Preventive Health Programme .
BACKGROUND	ClinicalTrials.gov PRS : NCT01969526 .
BACKGROUND	Date of registration : 10/21/2013 .

###24964164
BACKGROUND	According to a recent report from the European Brain Council and the European Colleague of Neuropsychopharmacology the one year prevalence of some kind of mental disorder is around 27 % among the adult population in Europe .
BACKGROUND	Research has shown a lack of mental health literacy in the population in general and it is thus important to find ways to improve the public 's knowledge and skills to provide first hand support to people with mental disorders .
BACKGROUND	Mental Health First Aid ( MHFA ) is a training program that has shown positive changes in knowledge and helping behavior .
BACKGROUND	This study investigates if MHFA training in a Swedish context provides a sustained improvement in knowledge about mental disorders , a better ability to be helpful in contacts with people who are ill and if it changes attitudes in a positive direction .
RESULTS	The introduction of the training program was made in accordance with the constructor 's instructions .
RESULTS	Participants were mainly public sector employees from a county in the west of Sweden .
RESULTS	The study was a randomized controlled trial with an experiment group ( n = 199 ) and a control group ( n = 207 ) placed on a waiting list during a 6-month follow-up .
RESULTS	A two-year follow-up was conducted for participants ( n = 155 ) from both the intervention and waiting list group who had completed the training and during the follow-up been in contact with persons with mental disorders .
RESULTS	The intervention group improved in knowledge as well as in confidence in providing help for someone in need .
RESULTS	The two-year follow-up showed that the improvements were to a great extent maintained .
CONCLUSIONS	Mental Health First Aid might raise the level of awareness of mental disorders and have an influence on the number of people who can receive professional treatment for their problems .

###25527749
BACKGROUND	Olive oil ( OO ) consumption is associated with cardiovascular disease prevention because of both its oleic acid and phenolic contents .
BACKGROUND	The capacity of OO phenolics to protect against low-density lipoprotein ( LDL ) oxidation is the basis for a health claim by the European Food Safety Authority .
BACKGROUND	Proteomic biomarkers enable an early , presymptomatic diagnosis of disease , which makes them important and effective , but understudied , tools for primary prevention .
OBJECTIVE	We evaluated the impact of supplementation with OO , either low or high in phenolics , on urinary proteomic biomarkers of coronary artery disease ( CAD ) , chronic kidney disease ( CKD ) , and diabetes .
METHODS	Self-reported healthy participants ( n = 69 ) were randomly allocated ( stratified block random assignment ) according to age and body mass index to supplementation with a daily 20-mL dose of OO either low or high in phenolics ( 18 compared with 286 mg caffeic acid equivalents per kg , respectively ) for 6 wk .
METHODS	Urinary proteomic biomarkers were measured at baseline and 3 and 6 wk alongside blood lipids , the antioxidant capacity , and glycation markers .
RESULTS	The consumption of both OOs improved the proteomic CAD score at endpoint compared with baseline ( mean improvement : -0.3 for low-phenolic OO and -0.2 for high-phenolic OO ; P < 0.01 ) but not CKD or diabetes proteomic biomarkers .
RESULTS	However , there was no difference between groups for changes in proteomic biomarkers or any secondary outcomes including plasma triacylglycerols , oxidized LDL , and LDL cholesterol .
CONCLUSIONS	In comparison with low-phenolic OO , supplementation for 6 wk with high-phenolic OO does not lead to an improvement in cardiovascular health markers in a healthy cohort .

###25330194
BACKGROUND	Non-steroidal anti-inflammatory drugs ( NSAIDs ) may cause gastrointestinal damage in dogs .
OBJECTIVE	To determine the extent to which lansoprazole , liquorice extract , and a herbal solution exhibit protective effects on colonic mucosa when administered to dogs concurrently with the NSAIDs carprofen or robenacoxib .
METHODS	Thirty-five healthy beagle dogs ( 15 male and 20 female ) aged 13-14 weeks and weighing 4.3-5 .5 kg at the beginning of the experiment were included .
METHODS	Endoscopy and biopsy of the caudal gastrointestinal tract were performed pretreatment and on the last day of a 21-day treatment period with ( 1 ) oral carprofen ; ( 2 ) carprofen and the proton-pump inhibitor lansoprazole ; ( 3 ) carprofen , liquorice extract , and a herbal solution that contained extracts of thyme , icelandic lichen , hyssop , and saponariae root ; ( 4 ) robenacoxib ; ( 5 ) robenacoxib and lansoprazole ; ( 6 ) robenacoxib , liquorice extract , and herbal solution ; or ( 7 ) an empty gelatin capsule .
METHODS	Statistical analyses were performed with the Kruskal-Wallis , Cochran 's Q , and chi-squared test with p < 0.05 considered significant .
RESULTS	Both carprofen and robenacoxib tested damaged the colonic mucosa with most severe microscopic lesions following administration of robenacoxib with lansoprazole .
RESULTS	The risk of histopathological lesions in the colon increased most rapidly in robenacoxib with lansoprazole ( absolute risk increase -0.85 ) similar to robenacoxib only ( -0.75 ) , whereas the best result was recorded following the plant remedies together with carprofen ( -0.15 ) and the plant remedies together with robenacoxib ( -0.2 ) .
CONCLUSIONS	Concurrent administration of liquorice extract and an herbal solution with robenacoxib was associated with decreased severity of the NSAID-induced mucosal lesions .

###24270165
OBJECTIVE	To compare 2 different training paradigms , massed vs interval training , when novice students learn a surgical procedure , myringotomy with ventilation tube insertion , on a validated surgical simulator .
METHODS	Medical students were randomized into 2 training groups : the interval group ( n = 19 ) was trained to perform the procedure in 5 trials/d over 3 days , and the massed group ( n = 21 ) was trained to perform the procedure in 15 trials all in 1 session .
METHODS	One week later , all students were tested in 5 additional final trials .
METHODS	Pre - and posttest surveys were administered .
METHODS	Academic medical center .
METHODS	Forty medical students : 19 students in the interval group were compared with 21 students in the massed group .
METHODS	Time to complete the procedure and number and type of error made were recorded and compared between groups .
METHODS	Pre - and poststudy surveys examined confidence levels working under a microscope and with the procedure .
RESULTS	Students in both groups had a significant decrease in time between practice and final trials .
RESULTS	In the final 5 trials , there was no difference in average time to complete the procedure between the massed and interval training groups .
RESULTS	No difference was observed in the number of errors committed per trial between initial and final trials ( both groups ) or between massed and interval training groups .
RESULTS	The students ' confidence levels significantly increased across the trials , regardless of group .
CONCLUSIONS	Surgical training improves proficiency , but method of training had little impact on proficiency in performing a simulated surgical procedure in this setting .

###24503784
BACKGROUND	The incretin hormone , glucagon-like peptide-1 , promotes myocardial glucose uptake and may improve myocardial tolerance to ischemia .
BACKGROUND	Endogenous glucagon-like peptide-1 ( 7-36 ) is augmented by pharmacological inhibition of dipeptidyl peptidase-4 .
BACKGROUND	We investigated whether chronic dipeptidyl peptidase-4 inhibition by sitagliptin protected against ischemic left ventricular dysfunction during dobutamine stress in patients with type 2 diabetes mellitus and coronary artery disease .
RESULTS	A total of 19 patients with type 2 diabetes mellitus underwent dobutamine stress echocardiography with tissue Doppler imaging on 2 separate occasions : the first ( control ) while receiving oral hypoglycemic agents , and the second after the addition of sitagliptin ( 100 mg once daily ) for 4 weeks .
RESULTS	Sitagliptin increased plasma glucagon-like peptide-1 ( 7-36 ) levels and , at peak stress , enhanced both global ( ejection fraction , 70.57.0 versus 65.78.0 % ; P < 0.0001 ; mitral annular systolic velocity , 11.72.6 versus 10.92.3 cm/s ; P = 0.01 ) and regional left ventricular function , assessed by peak systolic velocity and strain rate in 12 paired , nonapical segments .
RESULTS	This was predominantly because of a cardioprotective effect on ischemic segments ( strain rate in ischemic segments , -2.270.65 versus -1.980.58 s ( -1 ) ; P = 0.001 ) , whereas no effect was seen in nonischemic segments ( -2.190.48 versus -2.180.54 s ( -1 ) ; P = 0.87 ) .
RESULTS	At 30 minutes recovery , dipeptidyl peptidase-4 inhibition mitigated the postischemic stunning seen in the control scan .
CONCLUSIONS	The addition of dipeptidyl peptidase-4 inhibitor therapy with sitagliptin to the treatment regime of patients with type 2 diabetes mellitus and coronary artery disease is associated with a sustained improvement in myocardial performance during dobutamine stress and a reduction in postischemic stunning .
BACKGROUND	URL : http://www.isrctn.org .
BACKGROUND	Unique identifier ISRCTN61646154 .

###25187104
OBJECTIVE	Several reports have investigated amino acid administration in premature infants during the early postnatal phase .
OBJECTIVE	Most of these previous studies , however , have only evaluated short-term in-hospital outcomes .
OBJECTIVE	Our aim was to describe long-term outcomes in premature infants previously subjected to different nutritional regimens in a randomized controlled trial .
OBJECTIVE	The primary outcome was survival without major disabilities , and the secondary outcomes included anthropometry and mental development .
METHODS	Infants born < 32 weeks ' gestation and < 1500 g were randomized to receive glucose ( n = 69 ) or glucose with 2.4 g kg ( -1 ) day ( -1 amino acids ) ( n = 63 ) from birth .
METHODS	From postnatal day 3 onward , the nutritional intake was similar .
METHODS	At 2 years of corrected age , the surviving infants were assessed for neurodevelopmental outcome and anthropometry .
RESULTS	Ninety-seven percent of the surviving infants were examined at follow-up , with no overall effect on survival without major disabilities .
RESULTS	Boys , however , had a normal outcome significantly more often if amino acids were administered from birth onward ( crude odds ratio 3.8 , 95 % confidence interval 1.3-11 .4 ) and following adjustment for confounders ( odds ratio 6.2 , 95 % confidence interval 1.0-38 .0 ) .
RESULTS	The secondary outcomes exhibited no differences in anthropometric data .
RESULTS	The mental developmental index was lower in the small number of girls who survived without major disabilities following the early administration of amino acids .
CONCLUSIONS	In this hypothesis-generating outcome study , premature boys , but not girls , benefited from amino acid administration directly following birth .
CONCLUSIONS	The observed lower mental developmental index in a subgroup of girls , however , warrants further studies .

###24599578
BACKGROUND	Exercise may improve psychosocial distress in patients with cancer ; however , few studies have examined the effects of different types or doses of exercise , or whether exercise effects are related to baseline depression levels .
METHODS	In a multicenter trial in Canada , we randomized 301 patients with breast cancer initiating chemotherapy to thrice weekly , supervised exercise consisting of either a standard dose of 25 to 30 minutes of aerobic exercise ( STAN ; n = 96 ) , a higher dose of 50 to 60 minutes of aerobic exercise ( HIGH ; n = 101 ) , or a combined dose of 50 to 60 minutes of aerobic and resistance exercise ( COMB ; n = 104 ) .
METHODS	The primary endpoint was depression assessed by the Center for Epidemiological Studies-Depression scale at baseline , twice during chemotherapy , and postchemotherapy .
METHODS	Secondary endpoints were anxiety , perceived stress , and self-esteem .
RESULTS	Repeated measures ANOVA indicated that neither HIGH [ mean difference = -0.9 ; 95 % confidence interval ( CI ) , +0.0 to -1.8 ; P = 0.061 ] nor COMB ( mean difference = -0.4 ; 95 % CI , +0.5 to -1.3 ; P = 0.36 ) was superior to STAN for managing depressive symptoms .
RESULTS	In a planned subgroup analysis , there was a significant interaction with baseline depression levels ( P interaction = 0.027 ) indicating that COMB and HIGH were effective for managing depressive symptoms in patients with clinical levels of depressive symptoms at baseline .
CONCLUSIONS	Compared with a standard volume of aerobic exercise , higher volumes of exercise did not help manage depressive symptoms in unselected patients with breast cancer receiving chemotherapy , but they were effective in patients with clinical levels of depressive symptoms at baseline .
CONCLUSIONS	A phase III exercise trial targeting depressed patients with breast cancer is warranted .

###25428176
OBJECTIVE	To investigate the topical effect of dorzolamide versus ketorolac on retinitis pigmentosa ( RP ) and Usher 's syndrome ( US ) macular edema .
METHODS	Prospective , randomized and interventional study .
METHODS	A total of 28 eyes of 18 patients were included .
METHODS	Five eyes had US , 23 had RP .
METHODS	Fifteen eyes were allocated to ketorolac tromethamine 0.5 % ( 4 drops daily regimen ) and 13 eyes to dorzolamide hydrochloride 2 % ( 3 drops daily regimen ) treatment groups .
METHODS	Snellen 's best-corrected visual acuity ( BCVA ) , foveal thickness ( FT ) and foveal zone thickness ( FZT ) measured by Stratus optical coherence tomography ( OCT ) were evaluated at baseline , 1 , 3 , 6 and 12 months after treatment .
RESULTS	Patients assigned to ketorolac had a baseline BCVA of 0.37 0.17 logMAR which improved at the end of 1 year to 0.28 0.16 ( p = 0.02 ) .
RESULTS	Three eyes ( 20 % ) of 2 patients improved by 7 letters or more .
RESULTS	Mean FT and FZT did not change significantly during the study follow-up .
RESULTS	After 1 year of treatment , 4 eyes ( 27 % ) of 3 patients showed an improvement of at least 16 % of FT and 11 % of FZT .
RESULTS	Patients assigned to dorzolamide had a baseline BCVA of 0.48 0.34 logMAR which improved in the first 6 months ( 0.40 0.30 ; p = 0.01 ) , with a decrease at 1 year ( 0.42 0.27 ; p = 0.20 ) .
RESULTS	Seven eyes ( 54 % ) of 5 patients had an improvement of 7 letters or more .
RESULTS	Mean FT and FZT did not change significantly either .
RESULTS	After 1 year of treatment , 3 eyes ( 23 % ) of 2 patients showed an improvement of at least 16 % on FT and 11 % on FZT .
CONCLUSIONS	RESULTS suggest that dorzolamide and ketorolac might improve visual acuity and therefore be of interest in selected cases .
CONCLUSIONS	No relationship between retinal thickness fluctuation and visual acuity was found .
CONCLUSIONS	Sample size was a limitation to the study .

###24699259
BACKGROUND	Public health research on sedentary behavior ( SB ) in youth has heavily relied on accelerometers .
BACKGROUND	However , it has been limited by the lack of consensus on the most accurate accelerometer cut-points as well as by unknown effects caused by accelerometer position ( wrist vs. hip ) and output ( single axis vs. multiple axes ) .
BACKGROUND	The present study systematically evaluates classification accuracy of different Actigraph cut-points for classifying SB using hip and wrist-worn monitors and establishes new cut-points to enable use of the 3-dimensional vector magnitude data ( for both hip and wrist placement ) .
METHODS	A total of 125 children ages 7-13 yrs performed 12 randomly selected activities ( from a set of 24 different activities ) for 5 min each while wearing tri-axial Actigraph accelerometers on both the hip and wrist .
METHODS	The accelerometer data were categorized as either sedentary or non-sedentary minutes using six previously studied cut-points : 100 counts-per-minute ( CPM ) , 200 CPM , 300 CPM , 500 CPM , 800 CPM and 1100 CPM .
METHODS	Classification accuracy was evaluated with Cohen 's Kappa ( ) and new cut-points were identified from Receiver Operating Characteristic ( ROC ) .
RESULTS	Of the six cut-points , the 100 CPM value yielded the highest classification accuracy ( = 0.81 ) for hip placement .
RESULTS	For wrist placement , all of the cut-points produced low classification accuracy ( ranges of from 0.44 to 0.67 ) .
RESULTS	Optimal sedentary cut-points derived from ROC were 554.3 CPM ( ROC-AUC of 0.99 ) for vector magnitude for hip , 1756 CPM ( ROC-AUC of 0.94 ) for vertical axis for wrist , and 3958.3 CPM ( ROC-AUC of 0.93 ) for vector magnitude for wrist placement .
CONCLUSIONS	The 100 CPM was supported for use with vertical axis for hip placement , but not for wrist placement .
CONCLUSIONS	The ROC-derived cut-points can be used to classify youth SB with the wrist and with vector magnitude data .

###24770501
BACKGROUND	Fractional non-ablative lasers keep the epidermis intact , while fractional ablative lasers remove it , making them theoretically more effective .
OBJECTIVE	To evaluate the clinical and histological alterations induced by fractional photothermolysis for treating photoaging , comparing the possible equivalence of multiple sessions of 1540nm Erbium , to one session of 2940nm Erbium .
METHODS	Eighteen patients ( mean age 55.9 ) completed the treatment with three sessions of 1540nm fractional Erbium laser on one side of the face ( 50 mJ/mB , 15ms , 2 passes ) , and one session of 2940nm on the other side ( 5mJ/mB , 0.25 ms , 2 passes ) .
METHODS	Biopsies were performed before and 3 months after treatment .
METHODS	Clinical , histological and morphometric evaluations were carried out .
RESULTS	All patients presented clinical improvement with no statistically significant difference ( p > 0.05 ) between the treated sides .
RESULTS	Histopathology revealed a new organization of collagen and elastic fibers , accompanied by edema , which was more evident with the 2940nm laser .
RESULTS	This finding was confirmed by morphometry , which showed a decrease in collagen density for both treatments , with a statistical significance for the 2940nm laser ( p > 0.001 ) .
CONCLUSIONS	Three 1540nm sessions were clinically equivalent to one 2940nm session .
CONCLUSIONS	The edema probably contributed to the positive results after three months , togheter with the new collagen and elastic fibers organization .
CONCLUSIONS	The greater edema after the 2940nm session indicates that dermal remodeling takes longer than with 1540nm .
CONCLUSIONS	It is possible that this histological superiority relates to a more prolonged effect , but a cohort longer than three months is needed to confirm that supposition .

###25530603
OBJECTIVE	We examine effects of school support as a structural HIV prevention intervention for adolescent female orphans in Zimbabwe after 5years .
METHODS	Three hundred twenty-eight orphan adolescent girls were followed in a clustered randomized controlled trial from 2007 to 2010 .
METHODS	The experimental group received school fees , uniforms , and school supplies and were assigned a school-based `` helper . ''
METHODS	In 2011-2012 , the control group received delayed partial treatment of school fees only .
METHODS	At the final data point in 2012 , survey , HIV , and Herpes Simplex Virus Type 2 ( HSV-2 ) biomarker data were collected from approximately 88 % of the sample .
METHODS	Bivariate and multivariate analyses were conducted on end point outcomes , controlling for age , religious affiliation , and baseline socioeconomic status .
RESULTS	The two groups did not differ on HIV or HSV-2 biomarkers .
RESULTS	The comprehensive 5-year intervention continued to reduce the likelihood of marriage , improve school retention , improve socioeconomic status ( food security ) , and marginally maintain gains in quality of life , even after providing school fees to the control group .
CONCLUSIONS	Paying school fees and expenses resulted in significant improvements in life outcomes for orphan adolescent girls .
CONCLUSIONS	Biological evidence of HIV infection prevention , however , was not observed .
CONCLUSIONS	Our study adds to the growing body of research on school support as HIV prevention for girls in sub-Saharan Africa , but as yet , no clear picture of effectiveness has emerged .

###25411293
BACKGROUND	Elevated plasma homocysteine concentrations are a risk factor for osteoporotic fractures .
BACKGROUND	Lowering homocysteine with combined vitamin B-12 and folic acid supplementation may reduce fracture risk .
OBJECTIVE	This study [ B-vitamins for the PRevention Of Osteoporotic Fractures ( B-PROOF ) ] aimed to determine whether vitamin B-12 and folic acid supplementation reduces osteoporotic fracture incidence in hyperhomocysteinemic elderly individuals .
METHODS	This was a double-blind , randomized , placebo-controlled trial in 2919 participants aged 65 y with elevated homocysteine concentrations ( 12-50 mol/L ) .
METHODS	Participants were assigned to receive daily 500 g vitamin B-12 plus 400 g folic acid or placebo supplementation for 2 y. Both intervention and placebo tablets also contained 600 IU vitamin D3 .
METHODS	The primary endpoint was time to first osteoporotic fracture .
METHODS	Exploratory prespecified subgroup analyses were performed in men and women and in individuals younger than and older than age 80 y. Data were analyzed according to intention-to-treat and per-protocol principles .
RESULTS	Osteoporotic fractures occurred in 61 persons ( 4.2 % ) in the intervention group and 75 persons ( 5.1 % ) in the placebo group .
RESULTS	Osteoporotic fracture risk was not significantly different between groups in the intention-to-treat analyses ( HR : 0.84 ; 95 % CI : 0.58 , 1.21 ) or per-protocol analyses ( HR : 0.81 ; 95 % CI : 0.54 , 1.21 ) .
RESULTS	For persons aged > 80 y , in per-protocol analyses , osteoporotic fracture risk was lower in the intervention group than in the placebo group ( HR : 0.27 ; 95 % CI : 0.10 , 0.74 ) .
RESULTS	The total number of adverse events ( including mortality ) did not differ between groups .
RESULTS	However , 63 and 42 participants in the intervention and placebo groups , respectively , reported incident cancer ( HR : 1.56 ; 95 % CI : 1.04 , 2.31 ) .
CONCLUSIONS	These data show that combined vitamin B-12 and folic acid supplementation had no effect on osteoporotic fracture incidence in this elderly population .
CONCLUSIONS	Exploratory subgroup analyses suggest a beneficial effect on osteoporotic fracture prevention in compliant persons aged > 80 y. However , treatment was also associated with increased incidence of cancer , although the study was not designed for assessing cancer outcomes .
CONCLUSIONS	Therefore , vitamin B-12 plus folic acid supplementation can not be recommended at present for fracture prevention in elderly people .
CONCLUSIONS	The B-PROOF study was registered with the Netherlands Trial Register ( trialregister.nl ) as NTR1333 and at clinicaltrials.gov as NCT00696414 .

###25055492
OBJECTIVE	To assess the role of migraine history in the development of postoperative nausea and vomiting ( PONV ) in patients undergoing general and combined general-epidural anaesthesia .
METHODS	127 women with oncogynecological pathology were randomized into 3 groups according to anaesthesia method .
METHODS	Patients of the group C ( comparative group ; n = 43 ; 18 with migraine ) received general anaesthesia .
METHODS	Patients of the Group CA ( n = 40 ; 19 with migraine ) received combined general-epidural anaesthesia .
METHODS	Patients of the group D ( n = 44 ; 19 with migraine ) received general anaesthesia with adding of Droperidolum .
METHODS	All patients received standard prophylactics of PONV - Ondansetronum 8 mg and dexamethasone 8 mg intravenous .
RESULTS	In the group C a PONV occurred in 15 of 43 women ( 34.9 % ) .
RESULTS	PONV occurred in 6 of 18 women with migraine ( 33.3 % ) and in 9 of 25 women without migraine ( 36 % ) .
RESULTS	In the group CA a PONV occurred in 10 of 40 women ( 25 % ) .
RESULTS	PONV occurred in 8 of 19 women with migraine ( 42.1 % ) and in 2 of 21 women without migraine ( 9.5 % ; p = 0.036 in comparison with group C ) .
RESULTS	In the group D a PONV occurred in 8 of 44 women ( 18.2 % ) .
RESULTS	PONV occurred in 1 of 19 women with migraine ( 5.3 % p = 0.03 in comparison with group C and p = 0.008 with group CA ) and in 7 of 25 women without migraine ( 28 % ; there was no significant difference with groups C and CA ) .
CONCLUSIONS	Migraine history is a significant risk factor of PONV .
CONCLUSIONS	Epidural component of anaesthesia does not effect on frequency of PONV in women with migraine , but Droperidolum use allows increasing the frequency of PONV .

###24650843
BACKGROUND	Mobile technologies have wide-scale reach and disseminability , but no known studies have examined mobile technologies as a stand-alone tool to improve obesity-related behaviors of at-risk youth .
OBJECTIVE	To test a 12-week mobile technology intervention for use and estimate effect sizes for a fully powered trial .
METHODS	Fifty-one low-income , racial/ethnic-minority girls aged 9-14 years were randomized to a mobile technology ( n = 26 ) or control ( n = 25 ) condition .
METHODS	Both conditions lasted 12 weeks and targeted fruits/vegetables ( FVs ; Weeks 1-4 ) ; sugar-sweetened beverages ( SSBs ; Weeks 5-8 ) , and screen time ( Weeks 9-12 ) .
METHODS	The mobile intervention prompted real-time goal setting and self-monitoring and provided tips , feedback , and positive reinforcement related to the target behaviors .
METHODS	Controls received the same content in a written manual but no prompting .
METHODS	Outcomes included device utilization and effect size estimates of FVs , SSBs , screen time , and BMI .
METHODS	Data were collected and analyzed in 2011-2012 .
RESULTS	Mobile technology girls used the program on 63 % of days and exhibited trends toward increased FVs ( +0.88 , p = 0.08 ) and decreased SSBs ( -0.33 , p = 0.09 ) .
RESULTS	The adjusted difference between groups of 1.0 servings of FVs ( p = 0.13 ) and 0.35 servings of SSBs ( p = 0.25 ) indicated small to moderate effects of the intervention ( Cohen 's d = 0.44 and -0.34 , respectively ) .
RESULTS	No differences were observed for screen time or BMI .
CONCLUSIONS	A stand-alone mobile app may produce small to moderate effects for FVs and SSBs .
CONCLUSIONS	Given the extensive reach of mobile devices , this pilot study demonstrates the need for larger-scale testing of similar programs to address obesity-related behaviors in high-risk youth .

###24388010
BACKGROUND	Preliminary studies have suggested the efficacy of sublingual tablets of house dust mite ( HDM ) extracts in adults with allergic rhinitis .
OBJECTIVE	We sought to assess the efficacy and safety of 2 doses of HDM sublingual tablets over 1 treatment year and the subsequent immunotherapy-free year .
METHODS	Adults with HDM-associated allergic rhinitis were randomized in a double-blind , placebo-controlled study to receive 500 index of reactivity ( IR ) tablets , 300IR tablets , or placebo administered once daily for 1 year and were followed for the subsequent year .
METHODS	The primary efficacy variable was the Average Adjusted Symptom Score over the year 1 primary period ( ie , October 1 to December 31 ) .
METHODS	Symptoms and rescue medication scores , onset of action , patient-reported outcomes , and safety were secondary variables .
METHODS	The same end points were evaluated during the immunotherapy-free year .
METHODS	The primary efficacy end point was analyzed by using analysis of covariance .
RESULTS	Five hundred nine participants were randomized , and 427 continued in the immunotherapy-free year .
RESULTS	Both the 500IR and 300IR HDM sublingual tablets significantly reduced mean Average Adjusted Symptom Scores compared with placebo by -20.2 % ( P = .0066 ) and -17.9 % ( P = .0150 ) , respectively .
RESULTS	Efficacy of both doses was maintained during the treatment-free follow-up phase .
RESULTS	The onset of action was at 4 months .
RESULTS	Participants ' global evaluation of treatment success was significantly higher in the 500IR and 300IR groups compared with the placebo group ( P = .0206 and P = .0001 , respectively ) .
RESULTS	Adverse events were generally application-site reactions .
RESULTS	There were no reports of anaphylaxis .
CONCLUSIONS	Twelve months of treatment with 500IR and 300IR sublingual tablets of HDM allergen extracts was efficacious and well tolerated .
CONCLUSIONS	Efficacy was maintained during the treatment-free follow-up year .

###25319251
BACKGROUND	Advanced imaging may refine patient selection for ischemic stroke treatment but delays to acquire and process the imaging have limited implementation .
OBJECTIVE	We examined the feasibility of imaging selection in clinical practice using fully automated software in the EXTEND trial program .
METHODS	CTP and perfusion-diffusion MRI data were processed using fully-automated software to generate a yes/no ` mismatch ' classification that determined eligibility for trial therapies .
METHODS	The technical failure/mismatch classification error rate and time to image and treat with CT vs. MR-based selection were examined .
RESULTS	In a consecutive series of 776 patients from five sites over six-months the technical failure rate of CTP acquisition/processing ( uninterpretable maps ) was 34 % ( 26/776 , 95 % CI 22-49 % ) .
RESULTS	Mismatch classification was overruled by expert review in an additional 90 % ( 70/776 , 95 % CI 71-113 % ) due to artifactual ` perfusion lesion ' .
RESULTS	In 154 consecutive patients at one site , median additional time to acquire CTP after non-contrast CT was 65min .
RESULTS	Subsequent RAPID processing time varied from 3-10min across 20 trial centers ( median 5min 20s ) .
RESULTS	In the EXTEND trial , door-to-needle times in patients randomized on the basis of CTP ( n = 47 ) were median 78min shorter than MRI-selected ( n = 16 ) patients ( P < 0001 ) .
CONCLUSIONS	Automated CTP-based mismatch selection is rapid , robust in clinical practice , and associated with faster treatment decisions than MRI .
CONCLUSIONS	This technological advance has the potential to improve the standardization and reproducibility of interpretation of advanced imaging and extend use to practice settings beyond highly specialized academic centers .

###25355620
BACKGROUND	home visits and telephone calls are two often used approaches in transitional care , but their differential economic effects are unknown .
OBJECTIVE	to examine the differential economic benefits of home visits with telephone calls and telephone calls only in transitional discharge support .
METHODS	cost-effectiveness analysis conducted alongside a randomised controlled trial ( RCT ) .
METHODS	patients discharged from medical units randomly assigned to control ( control , N = 210 ) , home visits with calls ( home , N = 196 ) and calls only ( call , N = 204 ) .
METHODS	cost-effectiveness analyses were conducted from the societal perspective comparing monetary benefits and quality-adjusted life years ( QALYs ) gained .
RESULTS	the home arm was less costly but less effective at 28 days and was dominating ( less costly and more effective ) at 84 days .
RESULTS	The call arm was dominating at both 28 and 84 days .
RESULTS	The incremental QALY for the home arm was -0.0002 / 0.0008 ( 28/84 days ) , and the call arm was 0.0022 / 0.0104 ( 28/84 days ) .
RESULTS	When the three groups were compared , the call arm had a higher probability being cost-effective at 84 days but not at 28 days ( home : 53 % , call : 35 % ( 28 days ) versus home : 22 % , call : 73 % ( 84 days ) ) measuring against the NICE threshold of 20,000 .
CONCLUSIONS	the original RCT showed that the bundled intervention involving home visits and calls was more effective than calls only in the reduction of hospital readmissions .
CONCLUSIONS	This study adds a cost perspective to inform policymakers that both home visits and calls only are cost-effective for transitional care support , but calls only have a higher chance of being cost-effective for a sustained period after intervention .

###25880012
BACKGROUND	We conducted a phase 1 trial in patients with locally advanced cervical cancer by injecting 0.5 ml of the CK2-antagonist CIGB-300 in two different sites on tumours to assess tumour uptake , safety , pharmacodynamic activity and identify the recommended dose .
METHODS	Fourteen patients were treated with intralesional injections containing 35 or 70 mg of CIGB-300 in three alternate cycles of three consecutive days each before standard chemoradiotherapy .
METHODS	Tumour uptake was determined using ( 99 ) Tc-radiolabelled peptide .
METHODS	In situ B23/nucleophosmin was determined by immunohistochemistry .
RESULTS	Maximum tumour uptake for CIGB-300 70-mg dose was significantly higher than the one observed for 35 mg : 16.1 8.9 vs 31.3 12.9 mg ( P = 0.01 ) .
RESULTS	Both , AUC24h and biological half-life were also significantly higher using 70 mg of CIGB-300 ( P < 0.001 ) .
RESULTS	Unincorporated CIGB-300 diffused rapidly to blood and was mainly distributed towards kidneys , and marginally in liver , lungs , heart and spleen .
RESULTS	There was no DLT and moderate allergic-like reactions were the most common systemic side effect with strong correlation between unincorporated CIGB-300 and histamine levels in blood .
RESULTS	CIGB-300 , 70 mg , downregulated B23/nucleophosmin ( P = 0.03 ) in tumour specimens .
CONCLUSIONS	Intralesional injections of 70 mg CIGB-300 in two sites ( 0.5 ml per injection ) and this treatment plan are recommended to be evaluated in phase 2 studies .

###25379844
OBJECTIVE	To determine whether circular plastic wound edge protectors ( CWEPs ) significantly reduce the rate of surgical site infections ( SSIs ) in comparison to standard surgical towels in patients undergoing laparotomy .
BACKGROUND	SSIs cause substantial morbidity , prolonged hospitalization , and costs and remain one of the most frequent surgical complications .
BACKGROUND	CWEPs have been proposed as a measure to reduce the incidence of SSIs .
METHODS	In this randomized controlled , multicenter , 2-arm , parallel-group design , patient - and observer-blinded trial patients undergoing open elective abdominal surgery were assigned to either intraoperative wound coverage with a CWEP or standard coverage with surgical towels .
METHODS	Primary endpoint was superiority of intervention over control in terms of the incidence of SSIs within a 30-day postoperative period .
RESULTS	Between September 2010 and November 2012 , 608 patients undergoing laparotomy were randomized at 16 centers across Germany .
RESULTS	Three patients in the device group and 11 patients in the control group did not undergo laparotomy .
RESULTS	Patients ' and procedural characteristics were well balanced between the 2 groups .
RESULTS	Forty-eight patients discontinued the study prematurely , mainly because of relaparotomy ( control , n = 9 ; intervention , n = 9 ) and death ( control , n = 4 ; intervention , n = 7 ) .
RESULTS	A total of 79 patients experienced SSIs within 30 days of surgery , 27 of 274 ( 9.9 % ) in the device group and 52 of 272 ( 19.1 % ) in the control group ( odds ratio = 0.462 , 95 % confidence interval : 0.281-0 .762 ; P = 0.002 ) .
RESULTS	Subgroup analyses indicate that the effect could be more pronounced in colorectal surgery , and in clean-contaminated/contaminated surgeries .
CONCLUSIONS	Our trial shows that CWEPs are effective at reducing the incidence of SSIs in elective and clean or clean-contaminated open abdominal surgery .

###24660582
OBJECTIVE	To evaluate the curative effect of external application of the Chinese drug , Sanjierupi Gao , on mastalgia caused by mammary gland hyperplasia .
METHODS	This randomized , double-blinded , and placebo controlled study enrolled 260 patients with mammary gland hyperplasia from five hospitals .
METHODS	Patients were randomly and equally divided into a Sanjierupi Gao treatment group and a placebo control group .
METHODS	An adhesive plaster was applied to the most painful area on either breast for 7 h a day .
METHODS	Treatment lasted for two menstrual cycles without application during menstruation .
METHODS	Mastalgia was used as the main index of curative effect .
METHODS	The change before and after treatment in days of mastalgia , the time to alleviate pain , pain extent , and severe pain scores were observed .
RESULTS	Compared to the control group , the treatment group had significantly fewer days of mastalgia ( P < 0.01 ) , a significantly lower severe pain score ( P < 0.01 ) , and significantly less subjective pain and tenderness ( P < 0.05 and P < 0.01 , respectively ) .
RESULTS	Three days before the follow-up visit , the pain score in the treatment group was significantly lower than that in the control group ( P < 0.05 ) .
RESULTS	A non-parametric test was used to compare the time to alleviate mastalgia between the two groups and found no statistical difference ( Z = -0.313 , P = 0.754 ) .
CONCLUSIONS	Application of Sanjierupi Gao can decrease mastalgia duration in patients with mammary gland hyperplasia during menstruation and alleviate the extent of mastalgia .
CONCLUSIONS	The time to alleviate pain is psychologically influenced .

###24679362
OBJECTIVE	To compare the effect of two manual therapy techniques , mobilization with movement ( WB-MWM ) and talocrural manipulation ( HVLA ) , for the improvement of ankle dorsiflexion in people with chronic ankle instability ( CAI ) over 48 h.
METHODS	Randomized controlled clinical trial .
METHODS	University research laboratory .
METHODS	Fifty-two participants ( mean SD age , 20.7 3.4 years ) with CAI were randomized to WB-MWM ( n = 18 ) , HVLA ( n = 19 ) or placebo group ( n = 15 ) .
METHODS	Weight-bearing ankle dorsiflexion measured with the weight-bearing lunge .
METHODS	Measurements were obtained prior to intervention , immediately after intervention , and 10 min , 24 h and 48 h post-intervention .
RESULTS	There was a significant effect time ( F4 ,192 = 20.65 ; P < 0.001 ) and a significant time group interactions ( F8 ,192 = 6.34 ; P < 0.001 ) .
RESULTS	Post hoc analysis showed a significant increase of ankle dorsiflexion in both WB-MWM and HVLA groups with respect to the placebo group with no differences between both active treatment groups .
CONCLUSIONS	A single application of WB-MWM or HVLA manual technique improves ankle dorsiflexion in people with CAI , and the effects persist for at least two days .
CONCLUSIONS	Both techniques have similar effectiveness for improving ankle dorsiflexion although WB-MWM demonstrated greater effect sizes .

###25052710
OBJECTIVE	This cross-sectional study examined whether growth parameters were associated with epilepsy in children living in a rural community in sub-Saharan Africa ( SSA ) .
METHODS	A cross-sectional study was performed in the Hai District Demographic Surveillance Site ( HDSS ) , Tanzania in which 6-14 year old children with epilepsy ( CWE ) were identified .
METHODS	Age matched controls were randomly selected from the Hai census database for comparison .
METHODS	Anthropometric measurements were used to assess the nutritional status of the children and body mass index ( BMI ) calculated .
METHODS	Associations between social , demographic and nutritional factors and epilepsy were assessed using multivariable logistic regression .
RESULTS	112 CWE were identified and were compared with 113 controls .
RESULTS	There was no significant difference in the BMI between cases and controls ( T-test , p-value of 0.117 ) .
RESULTS	Amongst cases , there were no significant associations between BMI and motor difficulties , antiepileptic drug use , cognitive or behavioural problems , early-onset epilepsy or seizure frequency .
RESULTS	In the whole group , BMI was significantly associated with socio-economic status ( p = 0.037 ) and age .
CONCLUSIONS	There was no significant difference found between CWE and matched controls with respect to nutritional status .
CONCLUSIONS	This suggests that there is no causal association between under nutrition and epilepsy in this community .
CONCLUSIONS	Nutritional assessment is still important as part of the comprehensive care of CWE .

###24492949
OBJECTIVE	The objective of this study was to evaluate the effects of an exercise program focusing on muscle stretching and endurance training on the 12-month incidence of low back pain ( LBP ) in office workers .
METHODS	A 12-month prospective cluster-randomized controlled trial was conducted in healthy office workers with lower-than-normal trunk extension flexibility or trunk muscle endurance .
METHODS	Healthy office workers ( n = 563 ) were randomly assigned at the cluster level into either intervention ( n = 282 ) or control ( n = 281 ) groups .
METHODS	Participants in the intervention group received an exercise program that included daily stretching exercise and twice-a-week muscle endurance training .
METHODS	Those in the control group received no intervention .
METHODS	The 12-month incidence of LBP was the primary outcome .
METHODS	Secondary outcome were pain intensity , disability level , and quality of life and health status .
METHODS	Analyses were performed using the Cox proportional hazard models .
RESULTS	Over the 12-month follow-up , 8.8 % of participants in the intervention group and 19.7 % in the control group developed incidence of LBP .
RESULTS	Hazard rate ratios showed a protective effect of the exercise program for LBP ( HR = 0.37 , 95 % CI 0.22-0 .64 ) after adjusting for biopsychosocial factors .
RESULTS	There was no significant difference in pain intensity , disability , and quality of life and health status between those who reported incidence of LBP in the intervention and control groups .
CONCLUSIONS	An exercise program consisting of muscle stretching and endurance training is an effective intervention to reduce incident LBP for office workers with lower-than-normal trunk extension flexibility or trunk muscle endurance .

###24413845
BACKGROUND	Surgical treatment for displaced proximal humeral fractures is widely used .
BACKGROUND	However , there are very few randomized controlled studies comparing surgical treatment to conservative treatment , and the evidence is debated .
BACKGROUND	The aim of this study was to describe patients with displaced proximal humeral fractures in a 2-years extension of a randomized controlled trial , their functional outcome and quality of life .
METHODS	Patients from a single-center randomized controlled study of fifty patients aged 60 or above with displaced proximal humeral fracture ( AO/OTA group B2 or C2 ) were randomized to surgical or conservative treatment .
METHODS	Surgery was performed with an angular stable implant .
METHODS	The main outcome was Constant score at 2-year follow-up .
METHODS	Secondary outcomes were an ASES self-assessment form , the 15D quality of life assessment and radiographs at 2 years .
RESULTS	A marked improvement of shoulder function and health-related quality of life for both surgically and conservatively treated patients occurs between 6 and 12 months .
RESULTS	Almost no change was observed between 1 and 2 year .
RESULTS	There were no significant differences between the two treatments at 2-year follow-up .
CONCLUSIONS	In this randomized controlled trial , surgical treatment proved no better results than conservative treatment for patients with displaced proximal humeral fracture at 2-year follow-up .

###24919561
BACKGROUND	Workers without a permanent employment contract represent a vulnerable group within the working population .
BACKGROUND	Mental disorders are a major cause of sickness absence within this group .
BACKGROUND	Common mental disorders are stress-related , depressive and anxiety disorders .
BACKGROUND	To date , little attention has been paid to effective return to work interventions for this type of sick-listed workers .
BACKGROUND	Therefore , a participatory supportive return to work program has been developed .
BACKGROUND	It combines elements of a participatory return to work program , integrated care and direct placement in a competitive job.The objective of this paper is to describe the design of a randomised controlled trial to evaluate the cost-effectiveness of this program compared to care as usual .
METHODS	The cost-effectiveness of the participatory supportive return to work program will be examined in a randomised controlled trial with a follow-up of twelve months.The program strongly involves the sick-listed worker in the identification of obstacles for return to work and possible solutions , resulting in a consensus based action plan .
METHODS	This plan will be used as a starting point for the search of suitable competitive employment with support of a rehabilitation agency .
METHODS	During this process the insurance physician of the sick-listed worker contacts other caregivers to promote integrated care.Workers eligible to participate in this study have no permanent employment contract , have applied for a sickness benefit at the Dutch Social Security Agency and are sick-listed between two and fourteen weeks due to mental health problems.The primary outcome measure is the duration until first sustainable return to work in a competitive job .
METHODS	Outcomes are measured at baseline and after three , six , nine and twelve months .
CONCLUSIONS	If the participatory supportive return to work program proves to be cost-effective , the social security system , the sick-listed worker and society as a whole will benefit .
CONCLUSIONS	A cost-effective return to work program will lead to a reduction of costs related to sickness absence .
CONCLUSIONS	For the sick-listed worker a cost-effective program results in earlier sustainable return to work , which can be associated with both social and health benefits .
BACKGROUND	The trial registration number and date is NTR3563 , August 7 , 2012 .

###25493153
BACKGROUND	Mounting evidence suggests that high-fidelity mannequin-based ( HFMBS ) and computer-based simulation are useful adjunctive educational tools for advanced cardiac life support ( ACLS ) instruction .
BACKGROUND	We sought to determine whether access to a supplemental , online computer-based ACLS simulator would improve students ' performance on a standardized Mega Code using high-fidelity mannequin based simulation ( HFMBS ) .
METHODS	Sixty-five third-year medical students were randomized .
METHODS	Intervention group subjects ( n = 29 ) each received a two-week access code to the online ACLS simulator , whereas the control group subjects ( n = 36 ) did not .
METHODS	Primary outcome measures included students ' time to initiate chest compressions , defibrillate ventricular fibrillation , and pace symptomatic bradycardia .
METHODS	Secondary outcome measures included students ' subjective self-assessment of ACLS knowledge and confidence .
RESULTS	Students with access to the online simulator on average defibrillated ventricular fibrillation in 112 seconds , whereas those without defibrillated in 149.9 seconds , an average of 38 seconds faster [ p < .05 ] .
RESULTS	Similarly , those with access to the simulator paced symptomatic bradycardia on average in 95.14 seconds whereas those without access paced on average 154.9 seconds a difference of 59.81 seconds [ p < .05 ] .
RESULTS	On a subjective 5-point scale , there was no difference in self-assessment of ACLS knowledge between the control ( mean 3.3 ) versus intervention ( mean 3.1 ) [ p-value = .21 ] .
RESULTS	Despite having outperformed the control group subjects in the standardized Mega Code test scenario , the intervention group felt less confident on a 5-point scale ( mean 2.5 ) than the control group .
RESULTS	( mean 3.2 ) [ p < .05 ] .
CONCLUSIONS	The reduction in time to defibrillate ventricular fibrillation and to pace symptomatic bradycardia among the intervention group subjects suggests that the online computer-based ACLS simulator is an effective adjunctive ACLS instructional tool .

###25568388
BACKGROUND	Studies comparing operative with nonoperative treatment of a stable burst fracture of the thoracolumbar junction in neurologically intact patients have not shown a meaningful difference at early follow-up .
BACKGROUND	To our knowledge , longer-term outcome data have not before been presented .
METHODS	From 1992 to 1998 , forty-seven consecutive patients with a stable thoracolumbar burst fracture and no neurological deficit were evaluated and randomized to one of two treatment groups : operative treatment ( posterior or anterior arthrodesis ) or nonoperative treatment ( a body cast or orthosis ) .
METHODS	We previously reported the results of follow-up at an average of forty-four months .
METHODS	The current study presents the results of long-term follow-up , at an average of eighteen years ( range , sixteen to twenty-two years ) .
METHODS	As in the earlier study , patients at long-term follow-up indicated the degree of pain on a visual analog scale and completed the Roland and Morris disability questionnaire , the Oswestry Disability Index ( ODI ) questionnaire , and the Short Form-36 ( SF-36 ) health survey .
METHODS	Work and health status were obtained , and patients were evaluated radiographically .
RESULTS	Of the original operatively treated group of twenty-four patients , follow-up data were obtained for nineteen ; one patient had died , and four could not be located .
RESULTS	Of the original nonoperatively treated group of twenty-three patients , data were obtained for eighteen ; two patients had died , and three could not be located .
RESULTS	The average kyphosis was not significantly different between the two groups ( 13 for those who received operative treatment compared with 19 for those treated nonoperatively ) .
RESULTS	Median scores for pain ( 4 cm for the operative group and 1.5 cm for the nonoperative group ; p = 0.003 ) , ODI scores ( 20 for the operative group and 2 for the nonoperative group ; p < 0.001 ) and Roland and Morris scores ( 7 for the operative group and 1 for the nonoperative group ; p = 0.001 ) were all significantly better in the group treated nonoperatively .
RESULTS	Seven of eight SF-36 scores also favored nonoperative treatment .
CONCLUSIONS	While early analysis ( four years ) revealed few significant differences between the two groups , at long-term follow-up ( sixteen to twenty-two years ) , those with a stable burst fracture who were treated nonoperatively reported less pain and better function compared with those who were treated surgically .

###24436209
BACKGROUND	To evaluate the role of sonography ( US ) in assessing hypopharyngeal carcinoma when compared with CT. .
METHODS	A randomized prospective study was performed on 40 biopsy-proven cases of hypopharyngeal carcinoma.Contrast-enhanced CT of the neck was performed in all patients , followed by US .
METHODS	Sonographic identification of any tumor extension into the extralaryngeal soft tissues , postcricoid space , subglottis , thyroid gland , esophagus , and across the midline was recorded .
METHODS	US observations and CT findings were compared and then correlated with the histopathologic findings in 14 operative cases .
METHODS	In the remaining 26 inoperable cases , US was compared only with CT. .
RESULTS	Our cohort was composed of 38 men and 2 women ranging in age from 36 to 59 years .
RESULTS	In a subset of 14 operative patients , US had a sensitivity of 71.4 % ( 10/14 ) , while CT achieved a sensitivity of 92.8 % ( 13/14 ) , and the difference was not statistically significant ( p > 0.05 ) .
RESULTS	US and CT findings concurred in 67.5 % ( 27/40 ) of cases .
CONCLUSIONS	Even though small tumors are difficult to visualize , US can play a significant role in the assessment of tumor extension within and beyond the larynx , especially when cross-sectional imaging is either unavailable or unaffordable .

###24815326
OBJECTIVE	We investigated the effects of the fatty acid-bile acid conjugate 3-arachidyl-amido , 7-12-dihydroxy , 5-cholan-24-oic acid ( Aramchol ; Trima Israel Pharmaceutical Products Ltd , Maabarot , Israel ) in a phase 2 trial of patients with nonalcoholic fatty liver disease ( NAFLD ) .
METHODS	We performed a randomized , double-blind , placebo-controlled trial of 60 patients with biopsy-confirmed NAFLD ( 6 with nonalcoholic steatohepatitis ) at 10 centers in Israel .
METHODS	Patients were given Aramchol ( 100 or 300 mg ) or placebo once daily for 3 months ( n = 20/group ) .
METHODS	The main end point was the difference between groups in the change in liver fat content according to magnetic resonance spectroscopy .
METHODS	The secondary end points focused on the differences between groups in alterations of liver enzyme levels , levels of adiponectin , homeostasis model assessment scores , and endothelial function .
RESULTS	No serious or drug-related adverse events were observed in the 58 patients who completed the study .
RESULTS	Over 3 months , liver fat content decreased by 12.57 % 22.14 % in patients given 300 mg/day Aramchol , but increased by 6.39 % 36.27 % in the placebo group ( P = .02 for the difference between groups , adjusted for age , sex , and body mass index ) .
RESULTS	Liver fat content decreased in the 100-mg Aramchol group , by 2.89 % 28.22 % , but this change was nonsignificant ( P = .35 ) , indicating a dose-response relationship ( P for trend = .01 ) .
RESULTS	Groups given Aramchol had nonsignificant improvements over time in endothelial function and levels of alanine aminotransferase and adiponectin , but homeostasis model assessment scores did not change .
RESULTS	The appropriateness of a single daily dose was confirmed by pharmacokinetic analysis .
CONCLUSIONS	Three months ' administration of the fatty acid-bile acid conjugate Aramchol is safe , tolerable , and significantly reduces liver fat content in patients with NAFLD .
CONCLUSIONS	The reduction in liver fat content occurred in a dose-dependent manner and was associated with a trend of metabolic improvements , indicating that Aramchol might be used for the treatment of fatty liver disease .
CONCLUSIONS	ClinicalTrials.gov number : NCT01094158 .

###24891067
BACKGROUND	The 5-HT4 receptor agonist prucalopride is a prokinetic drug which improves colonic motility .
BACKGROUND	Animal data and in vitro studies suggest that prucalopride also affects gastric and esophageal motor function .
BACKGROUND	We aimed to assess the effect of prucalopride on gastric emptying , esophageal motility , and gastro-esophageal reflux in man .
METHODS	In this double-blind , placebo-controlled , randomized , crossover study , we included 21 healthy volunteers who received 4mg prucalopride or placebo per day for 6days .
METHODS	We performed high-resolution manometry ( HRM ) followed by 120-min HRM-pH-impedance monitoring after a standardized meal , ambulatory 24-h pH-impedance monitoring , and gastric emptying for solids .
RESULTS	Prucalopride decreased ( median [ IQR ] ) total acid exposure time ( 3.4 [ 2.5-5 .6 ] vs 1.7 [ 0.8-3 .5 ] % , p < 0.05 ) .
RESULTS	The total number of reflux events was unaffected by prucalopride , however , the number of reflux events extending to the proximal esophagus was reduced by prucalopride ( 15.5 [ 9.8-25 .5 ] vs 10.5 [ 5.3-17 .5 ] , p < 0.05 ) .
RESULTS	Furthermore , prucalopride improved acid clearance time ( 77.5 [ 47.8-108 .8 ] vs 44.0 [ 30.0-67 .8 ] s , p < 0.05 ) .
RESULTS	Prucalopride did not affect the number of transient lower esophageal sphincter ( LES ) relaxations or their association with reflux events .
RESULTS	Esophageal motility and basal pressure of the LES were not affected by prucalopride .
RESULTS	Prucalopride increased gastric emptying ( T1/2 ; 32.7 [ 27.9-44 .6 ] vs 49.8 [ 37.7-55 .0 ] min , p < 0.05 ) and decreased residue after 120min ( 8.8 [ 4.4-14 .8 ] vs 2.7 [ 1.3-5 .4 ] % , p < 0.05 ) .
CONCLUSIONS	Prucalopride reduces esophageal acid exposure and accelerates gastric emptying in healthy male volunteers .
CONCLUSIONS	These findings suggest that the drug could be effective for treatment of patients with reflux disease and functional dyspepsia .

###24557009
OBJECTIVE	The primary therapeutic goals in ulcerative colitis ( UC ) are to maintain excellent quality of life ( QOL ) by treating flare-ups when they occur , and preventing flare-ups .
OBJECTIVE	Since stress can trigger UC flare-ups , we investigated the efficacy of mindfulness-based stress reduction ( MBSR ) to reduce flare-ups and improve QOL .
METHODS	Patients with moderately severe UC , in remission , were randomized to MBSR or time/attention control .
METHODS	Primary outcome was disease status .
METHODS	Secondary outcomes were changes in markers of inflammation and disease activity , markers of stress and psychological assessments .
RESULTS	55 subjects were randomized .
RESULTS	Absence of flares , time to flare and severity of flare over 1 year were similar between the two groups .
RESULTS	However , post hoc analysis showed that MBSR decreased the proportion of participants with at least one flare-up among those with top tertile urinary cortisol and baseline perceived stress ( 30 vs. 70 % ; p < 0.001 ) .
RESULTS	MBSR patients who flared demonstrated significantly lower stress at the last visit compared to flared patients in the control group ( p = 0.04 ) .
RESULTS	Furthermore , MBSR prevented a drop in the Inflammatory Bowel Disease Quality of Life Questionnaire during flare ( p < 0.01 ) .
CONCLUSIONS	MBSR did not affect the rate or severity of flare-ups in UC patients in remission .
CONCLUSIONS	However , MBSR might be effective for those with high stress reactivity ( high perceived stress and urinary cortisol ) during remission .
CONCLUSIONS	MBSR appears to improve QOL in UC patients by minimizing the negative impact of flare-ups on QOL .
CONCLUSIONS	Further studies are needed to identify a subset of patients for whom MBSR could alter disease course .

###24687538
OBJECTIVE	Monitoring patient-reported symptoms is necessary to adjust and improve supportive care during chemotherapy .
OBJECTIVE	Continuing advances in computerized approaches to symptom monitoring can enhance communication about unrelieved symptoms between patients and oncology providers and may facilitate intensified symptom treatment .
METHODS	An automated IT-based telephone monitoring system was developed to enable oncology providers to receive and act on alert reports from patients about unrelieved symptoms during chemotherapy treatment .
METHODS	Daily , 250 participants ( randomized to treatment or attentional control ) were asked to call the automated system to report presence , severity , and distress for common chemotherapy-related symptoms ( 1-10 scale if present ) .
METHODS	For the treatment group , symptoms exceeding preset thresholds for moderate-to-severe intensity levels generated emailed alert reports to both the patient 's oncologist and oncology nurse .
RESULTS	Patients reported high satisfaction and ease of use of the automated system .
RESULTS	Over 80 % of providers reported usefulness of the symptom alert reports .
RESULTS	Ten monitored symptoms resulted in , on average , nine moderate-to-severe intensity alerts per patient over 45 study days .
RESULTS	However , providers rarely contacted patients after receiving alerts .
RESULTS	There were no significant differences in change of symptom severity between the two groups ( mean difference = 0.06 , p = 0.58 ) .
CONCLUSIONS	Despite patients ' use of a daily symptom monitoring system and providers ' receipt of information about unrelieved symptoms of moderate-to-severe intensity , oncology physicians and nurses did not contact patients to intensify symptom treatment nor did symptoms improve .
CONCLUSIONS	Further research is indicated to determine if oncology providers initiated follow-up to intensify symptom treatment , whether symptom outcomes would improve .

###25599538
OBJECTIVE	To compare the influence of femtosecond lenticule extraction ( FLEx ) and small incision lenticule extraction ( SMILE ) on corneal nerve density and the ocular surface for equivalent degrees of correction of myopia .
METHODS	Sixty eyes of 30 patients ( 8 males and 22 females , mean age : 31.0 6.0 years ) were included in the study .
METHODS	The patients underwent FLEx in 1 eye and SMILE in the other eye by random assignment .
METHODS	Subbasal nerve density was measured using confocal microscopy preoperatively and at 1 week , 1 and 3 months , and 1 year postoperatively .
METHODS	Ocular surface parameters such as Schirmer 's test results , tear film break-up time , and corneal sensation were performed preoperatively and at 1 and 3 months postoperatively .
RESULTS	In the FLEx group , subbasal nerve density was 18,390 6,090 m/mm ( 2 ) preoperatively and 5,770 3,490 m/mm ( 2 ) at 1 year postoperatively ( P < .001 , Dunnett 's test ) .
RESULTS	In the SMILE group , subbasal nerve density was 16,810 6,220 m/mm ( 2 ) preoperatively and 11,870 8,200 m/mm ( 2 ) at 1 year postoperatively ( P = .21 ) .
RESULTS	The decrease in corneal nerve density was significantly less after SMILE than after FLEx at all postoperative visits ( Mann-Whitney U test , P < .05 ) .
RESULTS	FLEx resulted in a significant decrease in Schirmer 's test results , tear film break-up time , and corneal sensation at all postoperative visits , whereas SMILE induced no significant changes in these parameters ( P > .05 ) .
CONCLUSIONS	There was less damage to the sub-basal nerve plexus of the cornea and less effect on the ocular surface parameters after SMILE than after FLEx .

###24826474
OBJECTIVE	To compare statics characteristics between anterior transpedicular screws ( ATPS ) system and vertebral body screws ( VBS ) system in lower cervical spine .
METHODS	Sixteen fresh cervical specimens were collected and dissected into 32 different units ( functional spinal unit , FSU ) , 8 units in C3 ,4 , C4 ,5 , C5 ,6 and C6 ,7 each .
METHODS	The subjects were randomly divided into group A and B.
METHODS	The anterior transpedicular screw-plate system and anterior vertebral body screw-plate system were implanted separately in group A and B. Then , the maximum axial pull out strength was tested and compared between two fixation system .
RESULTS	Maximum pull out strength was ( 604.68 + / - 48.76 ) N in group A and ( 488.24 + / - 32.42 ) N in group B , and there was significant difference between two groups ( t = 2.147 , P < 0.05 ) .
RESULTS	There was no statistically significant difference in all FSU between anterior transpedicular screws system and vertebral body screws system ( F ( A ) = 2.27 , F ( B ) = 2.05 , P > 0.05 ) .
CONCLUSIONS	The pull out strength of anterior transpedicular screws system is better than vertebral body screws system , and the anterior transpedicular screws has the biomechanical feasibility in clinic .

###25675384
BACKGROUND	Activation of the melanocortin-4 receptor ( MC4R ) with the synthetic agonist RM-493 decreases body weight and increases energy expenditure ( EE ) in nonhuman primates .
BACKGROUND	The effects of MC4R agonists on EE in humans have not been examined to date .
OBJECTIVE	In a randomized , double-blind , placebo-controlled , crossover study , we examined the effects of the MC4R agonist RM-493 on resting energy expenditure ( REE ) in obese subjects in an inpatient setting .
METHODS	Twelve healthy adults ( 6 men and 6 women ) with body mass index of 35.7 2.9 kg/m ( 2 ) ( mean SD ) received RM-493 ( 1 mg/24 h ) or placebo by continuous subcutaneous infusion over 72 hours , followed immediately by crossover to the alternate treatment .
METHODS	All subjects received a weight-maintenance diet ( 50 % carbohydrate , 30 % fat , and 20 % protein ) and performed 30 minutes of standardized exercise daily .
METHODS	Continuous EE was measured on the third treatment day in a room calorimeter , and REE in the fasting state was defined as the mean of 2 30-minute resting periods .
RESULTS	RM-493 increased REE vs placebo by 6.4 % ( 95 % confidence interval , 0.68-13 .02 % ) , on average by 111 kcal/24 h ( 95 % confidence interval , 15-207 kcal , P = .03 ) .
RESULTS	Total daily EE trended higher , whereas the thermic effect of a test meal and exercise EE did not differ significantly .
RESULTS	The 23-hour nonexercise respiratory quotient was lower during RM-493 treatment ( 0.833 0.021 vs 0.848 0.022 , P = .02 ) .
RESULTS	No adverse effect on heart rate or blood pressure was observed .
CONCLUSIONS	Short-term administration of the MC4R agonist RM-493 increases REE and shifts substrate oxidation to fat in obese individuals .

###26041849
BACKGROUND	Conventional total knee arthroplasty is performed with use of an intramedullary alignment guide , which produces elevated intramedullary pressure that can create fat emboli .
BACKGROUND	Total knee arthroplasty performed via computer-assisted surgery does not require an intramedullary femoral rod , raising the question of whether computer-assisted surgery generates less embolic material than conventional total knee arthroplasty .
BACKGROUND	The purpose of this study was to compare the emboli produced in the two techniques .
METHODS	Fifty-seven patients were randomized into two groups : the computer-assisted surgery group ( n = 29 ) and the conventional total knee arthroplasty group ( n = 28 ) .
METHODS	An intramedullary femoral alignment jig was used in the conventional total knee arthroplasty group but not in the computer-assisted surgery group .
METHODS	Intraoperative invasive monitoring was performed with use of transesophageal echocardiography and a pulmonary artery catheter .
RESULTS	The mean embolic score was 6.21 points for the conventional technique group and 5.48 points for the computer-assisted surgery group ( p = 0.0161 ) .
RESULTS	After tourniquet deflation , fat emboli were observed in the blood of five patients in the conventional surgery group and one patient in the computer-assisted surgery group .
CONCLUSIONS	The patients in the computer-assisted surgery group had lower embolic loads compared with the patients in the conventional total knee arthroplasty group .
CONCLUSIONS	In patients with an uncompromised cardiopulmonary system , the embolic load difference between the techniques was not clinically relevant .
METHODS	Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence .

###25366037
BACKGROUND	Cardiovascular disease , endothelial dysfunction , and oxidative stress are common complications among patients with type 2 diabetes ( T2DM ) .
BACKGROUND	In addition to the average blood glucose concentration , glycemic variability may be an important factor for the development of chronic diabetes complications .
BACKGROUND	Patients with T2DM are treated with various types of oral glucose-lowering drugs .
BACKGROUND	Exercise is considered to benefit the health of both healthy and unhealthy individuals , which has been confirmed by a number of scientific research studies in which the participants ' health improved .
BACKGROUND	Our general aim in this study will be to evaluate glucose variability after submaximal exercise test in patients receiving treatment with either vildagliptin or glibenclamide .
BACKGROUND	The specific aims of this study are to evaluate the oxidative stress , endothelial function , and metabolic and cardiovascular responses to exercise under treatment with vildagliptin or glibenclamide .
BACKGROUND	All these responses are important in patients with T2DM .
METHODS	This study is a PROBE ( Prospective , Randomized , Open-label , Blinded-Endpoint ) design clinical trial .
METHODS	The estimated sample needed is 20 patients with T2DM .
METHODS	In addition to the routine treatment ( metformin ) , patients will receive a second drug orally for 12 weeks : the METV group will receive metformin plus vildagliptin ( 50 mg twice daily ) , and the METG group will receive metformin plus glibenclamide ( 5 to 10 mg twice daily . )
METHODS	Before and after intervention , evaluation of glycemic variability , endothelial function , oxidative stress , and metabolic and cardiovascular response will be performed at rest , during and after a submaximal exercise test ( 30 minutes , with an intensity based at 10 % under the heart rate at the second threshold ) .
CONCLUSIONS	In addition to drug treatment , exercise is recommended for treatment of glycemic control in patients with T2DM , especially for its beneficial effects on blood glucose and HbA1c .
CONCLUSIONS	Few studies have determined the effects of the association between exercise and oral glucose-lowering drugs .
CONCLUSIONS	The study will be conducted to assess the metabolic and cardiovascular responses at rest , and during and after submaximal exercise in patients receiving one of two oral glucose-lowering drugs ( vildagliptin or glibenclamide ) .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01867502 study release date : May-17-2013 .

###24928848
BACKGROUND	Injury knowledge and beliefs influence uptake of prevention programmes , but the relationship between knowledge , beliefs and adherence remains unclear .
OBJECTIVE	To describe injury knowledge and beliefs among youth female soccer coaches and players , and to identify the relationship between these factors , different delivery strategies of the FIFA 11 + programme and adherence .
METHODS	A subcohort analysis from a cluster-randomised controlled trial of 31 female soccer teams ( coaches n = 29 , players ( ages 13-18 ) n = 258 ) .
METHODS	Preseason and postseason questionnaires were used to assess knowledge and beliefs .
METHODS	Teams recorded FIFA 11 + adherence during the season .
RESULTS	At baseline , 62.8 % ( 95 % CI 48.4 % to 77.3 % ) of coaches and 75.8 % ( 95 % CI 71.5 % to 80.1 % ) of players considered ` inadequate warm-up ' a risk factor for injury .
RESULTS	There was no effect of delivery method ( OR = 1.1 ; 95 % CI 0.8 to 1.5 ) or adherence ( OR = 1.0 ; 95 % CI 0.9 to 1.1 ) on this belief .
RESULTS	At baseline , 13.8 % ( 95 % CI 1.3 % to 26.4 % ) of coaches believed a warm-up could prevent muscle injuries , but none believed it could prevent knee and ankle injuries .
RESULTS	For players , 9.7 % ( 95 % CI 6.1 % to 13.3 % ) , 4.7 % ( 95 % CI 2.1 % to 7.3 % ) and 4.7 % ( 95 % CI 2.1 % to 7.3 % ) believed a warm-up would prevent muscle , knee and ankle injuries , respectively .
RESULTS	Years of playing experience were negatively associated with high adherence for coaches ( OR = 0.93 ; 0.88 to 0.99 ) and players ( OR = 0.92 ; 0.85 to 0.98 ) .
CONCLUSIONS	There were gaps in injury knowledge and beliefs , which differed for coaches and players .
CONCLUSIONS	Beliefs did not significantly affect adherence to the FIFA 11 + , suggesting additional motivational factors should be considered .

###24616241
OBJECTIVE	Social network analysis was used to examine whether peer influence from one 's social networks moderates obesity prevention program effects on obesity-related behaviors : healthful and unhealthful .
METHODS	Participants included 557 children residing in Southern California .
METHODS	The survey assessed health-promoting behaviors ( i.e. , physical activity at school , physical activity outside of school , and fruit and vegetable intake ) , as well as unhealthful behaviors ( high-calorie , low-nutrient intake and sedentary activity ) , and peer exposure calculated from social network nominations as indicators of peer influence .
METHODS	Multilevel models were conducted separately on outcomes predicted by program participation , peer exposure , and program participation by peer exposure .
RESULTS	Results indicated that peer exposure was positively associated with one 's own healthful and unhealthful behaviors .
RESULTS	Program participation effects were moderated by peer influence , but only when unhealthful peer influence was present .
RESULTS	Results suggest that peer influence can diminish or amplify prevention programs
CONCLUSIONS	Future interventions should consider peer-led components to promote healthful influence of peers on healthful and unhealthful behaviors , and programs should be mindful that their effects are moderated by social networks .

###24708623
BACKGROUND	Chronic obstructive pulmonary disease ( COPD ) remains a major health problem , strongly related to smoking .
BACKGROUND	Despite the publication of practice guidelines on prevention and treatment , not all patients with the disease receive the recommended healthcare , particularly with regard to smoking cessation advice where applicable .
BACKGROUND	We have developed a tailored implementation strategy for enhancing general practitioners ' adherence to the disease management guidelines .
BACKGROUND	The primary aim of the study is to evaluate the effects of this tailored implementation intervention on general practitioners ' adherence to guidelines .
METHODS	A pragmatic two-arm cluster randomized trial has been planned to compare care following the implementation of tailored interventions of four recommendations in COPD patients against usual care .
METHODS	The study will involve 18 general practices ( 9 in the intervention group and 9 in the control group ) in Poland , each with at least 80 identified ( at the baseline ) patients with diagnosed COPD .
METHODS	The nine control practices will provide usual care without any interventions .
METHODS	Tailored interventions to implement four recommendations will be delivered in the remaining nine practices .
METHODS	At follow-up after nine months , data will be collected for all 18 general practices .
METHODS	The primary outcome measure is physicians ' adherence to all four recommendations : brief anti-smoking advice , dyspnea assessment , care checklist utilization and demonstration to patients of correct inhaler use .
METHODS	This measurement will be based on data extracted from identified patients ' records .
METHODS	Additionally , we will survey and interview patients with chronic obstructive pulmonary disease about the process of care .
CONCLUSIONS	The results of this trial will be directly applicable to primary care in Poland and add to the growing body of evidence on interventions to improve chronic illness care .
BACKGROUND	This trial has been registered with Clinical Trials Protocol Registration System .
BACKGROUND	NCT01893476 .

###25495209
OBJECTIVE	Despite widespread use internationally , there is no convincing evidence that community treatment orders ( CTO ) ( legal regimes making out-patient treatment compulsory ) , reduce readmission rates or have wider patient benefit .
OBJECTIVE	The primary and secondary outcomes of the Oxford Community Treatment Order Evaluation Trial ( OCTET ) ( hospitalisation ) showed no benefit .
OBJECTIVE	This article will , first , test the effect of community compulsion on wider clinical and social outcomes and on patients ' experiences of services and the use of treatment pressure and second , explore differential effects in different groups of patients .
METHODS	OCTET is a RCT of CTO effectiveness .
METHODS	Three hundred and thirty-six patients were randomised and data for the 333 eligible patients were collected from interviews and medical records at baseline , 6 and 12months .
RESULTS	There was no significant difference at 12 months between the two arms in any of the reported outcomes , except a small difference in patients ' view of the effectiveness of treatment pressure , which is unlikely to be clinically meaningful .
RESULTS	Two statistically significant interactions were found in the subgroup analysis : symptoms interacted with age and with education , but no pattern was demonstrated .
CONCLUSIONS	CTOs do not have benefit on any of the tested outcomes , or for any subgroup of patients .
CONCLUSIONS	Their continued use should be carefully reconsidered .

###25920384
OBJECTIVE	Tobacco use is common among emergency department ( ED ) patients , many of whom have low income .
OBJECTIVE	Our objective is to study the efficacy of an intervention incorporating motivational interviewing , nicotine replacement , and quitline referral for adult smokers in an ED .
METHODS	This was a 2-arm randomized clinical trial conducted from October 2010 to December 2012 in a northeastern urban US ED with 90,000 visits per year .
METHODS	Eligible subjects were aged 18 years or older , smoked , and were self-pay or had Medicaid insurance .
METHODS	Intervention subjects received a motivational interview by a trained research assistant , 6 weeks ' worth of nicotine patches and gum initiated in the ED , a faxed referral to the state smokers ' quitline , a booster call , and a brochure .
METHODS	Control subjects received the brochure , which provided quitline information .
METHODS	The primary outcome was biochemically confirmed tobacco abstinence at 3 months .
METHODS	Secondary endpoints included quitline use .
RESULTS	Of 778 enrolled subjects , 774 ( 99.5 % ) were alive at 3 months .
RESULTS	The prevalence of biochemically confirmed abstinence was 12.2 % ( 47/386 ) in the intervention arm versus 4.9 % ( 19/388 ) in the control arm , for a difference in quit rates of 7.3 % ( 95 % confidence interval 3.2 % to 11.5 % ) .
RESULTS	In multivariable logistic modeling controlling for age , sex , and race or ethnicity , study subjects remained more likely to be abstinent than controls ( odds ratio 2.72 ; 95 % confidence interval 1.55 to 4.75 ) .
CONCLUSIONS	An intensive intervention improved tobacco abstinence rates in low-income ED smokers .
CONCLUSIONS	Because approximately 20 million smokers , many of whom have low income , visit US EDs annually , these results suggest that ED-initiated treatment may be an effective technique to treat this group of smokers .

###25227981
OBJECTIVE	We evaluated the cross-time association between midlife dietary vitamin D intake and subsequent cognitive performance in a French general-population sample .
METHODS	Data from participants in both the SU.VI.MAX trial ( 1994-2002 ) and the SU.VI.MAX 2 observational study ( 2007-2009 ) were used .
METHODS	Dietary intake was estimated at baseline from 6 or more 24-hour records .
METHODS	Cognitive performance was evaluated 13 years later with a comprehensive neuropsychological battery .
METHODS	Parameter estimates of cognitive performance according to quartiles ( Q ) of vitamin D intake were estimated via ANCOVA .
RESULTS	In a sample of 1,990 aging adults , principal component analyses yielded two cognitive factors - for episodic/semantic memory and short-term memory/executive function ; however , neither one displayed associations with dietary vitamin D intake .
RESULTS	Midlife vitamin D intake was significantly and positively associated with scores on the forward digit span task measuring short-term memory ( fully adjusted model : mean difference , Q4 vs. Q1 = 1.95 ; 95 % CI 0.37-3 .53 ; p ( trend ) = 0.03 ) .
RESULTS	No significant interaction with either sex or lifetime sun exposure was found .
CONCLUSIONS	Midlife vitamin D intake exhibited a cross-time and domain-specific association with cognition in the context of aging .
CONCLUSIONS	Further investigations in this area of prevention are warranted given the rapidly expanding elderly population and the absence of curative treatment for dementia .

###25089931
BACKGROUND	Death from infection is a highly heritable trait , yet there are few genetic variants with known mechanism influencing survival during septic shock .
OBJECTIVE	We hypothesized that a synonymous coding variant in the IL-1 receptor antagonist gene ( IL1RN ) , rs315952 , previously associated with reduced risk for acute respiratory distress syndrome , would be functional and associate with improved survival in septic shock .
METHODS	We used a human endotoxin ( LPS ) model of evoked inflammatory stress to measure plasma IL-1 receptor antagonist ( IL1RA ) following low-dose Food and Drug Administration-grade LPS injection ( 1 ng/kg ) in 294 human volunteers .
METHODS	RNA sequencing of adipose tissue pre - and post-LPS was used to test for allelic imbalance at rs315952 .
METHODS	In the Vasopressin and Septic Shock Trial cohort , we performed a genetic association study for survival , mortality , and organ failure-free days .
RESULTS	Adipose tissue displayed significant allelic imbalance favoring the rs315952C allele in subjects of European ancestry .
RESULTS	Consistent with this , carriers of rs315952C had slightly higher plasma IL1RA at baseline ( 0.039 ) and higher evoked IL1RA post-LPS ( 0.011 ) .
RESULTS	In the Vasopressin and Septic Shock Trial cohort , rs315952C associated with improved survival ( P = 0.028 ) , decreased adjusted 90-day mortality ( P = 0.044 ) , and faster resolution of shock ( P = 0.029 ) .
CONCLUSIONS	In European ancestry subjects , the IL1RN variant rs315952C is preferentially transcribed and associated with increased evoked plasma IL1RA and with improved survival from septic shock .
CONCLUSIONS	It may be that genetically determined IL1RA levels influence survival from septic shock .

###24282870
OBJECTIVE	The aim of this investigation was to assess the comparative gingivitis and plaque reduction efficacy of a leading oscillating-rotating power toothbrush and a recently introduced sonic toothbrush in adults with gingivitis .
METHODS	This was a 12-week , randomized and controlled , parallel group , examiner-blind , single-center clinical study of 130 adults with pre-existing gingivitis and plaque .
METHODS	At baseline , the Modified Gingival Index ( MGI ) , Gingival Bleeding Index ( GBI ) , and total number of bleeding sites were assessed , along with plaque levels ( whole mouth , gingival margin , and interproximal ) via the Rustogi Modified Navy Plaque Index ( RMNPI ) .
METHODS	Qualified subjects were randomly assigned to one of two power toothbrush test groups : the Oral-B Triumph with SmartGuide ( marketed in the United States as the Oral-B Professional Care SmartSeries 5000 [ D34 ] ) oscillating-rotating brush , or the Colgate ProClinical A1500 ( also marketed as elmex ProClinical ) sonic brush .
METHODS	Subjects brushed at home for two minutes twice daily with their assigned power toothbrush and a marketed sodium fluoride dentifrice , and were reevaluated for gingivitis at Week 4 and Week 12 via the MGI , GBI , and total number of bleeding sites , and for plaque reduction via the RMNPI .
RESULTS	Ninety-seven percent ( 97 % ) of the 130 enrolled subjects completed the trial and 62 and 65 subjects in the oscillating-rotating and sonic brush groups , respectively , had evaluable data for analysis .
RESULTS	Statistically significant mean reductions in all three gingivitis parameters and plaque relative to baseline were seen at both Weeks 4 and 12 with unsupervised use of both test toothbrushes ( p < 0.001 ) .
RESULTS	The oscillating-rotating power brush provided statistically significantly superior reductions compared to the sonic brush in mean adjusted MGI ( 31 % and 29 % at Weeks 4 and 12 , respectively ; p < 0.001 ) , GBI ( 17 % at Week 12 ; p = 0.047 ) , and total number of bleeding sites ( 48 % and 30 % at Weeks 4 and 12 , respectively ; p = 0.002 ) , and produced statistically significantly greater relative mean adjusted plaque reductions for RMNPI whole mouth plaque ( 38 % and 24 % at Weeks 4 and 12 , respectively ; p < 0.001 ) , gingival margin plaque ( 36 % at Week 4 ; p = 0.004 ) , and interproximal plaque ( 39 % and 26 % at Weeks 4 and 12 , respectively ; p < 0.001 ) .
RESULTS	Both power toothbrushes were well-tolerated .
CONCLUSIONS	An advanced oscillating-rotating power toothbrush produced substantial , statistically superior reductions in plaque and gingivitis via multiple outcome measures compared to a new sonic toothbrush after both four weeks and 12 weeks of tooth brushing .

###25247944
OBJECTIVE	The objective of our study was to determine the feasibility of using Metal Artifact Reduction ( MAR ) software for abdominopelvic dual-energy CT in patients with metal hip prostheses .
METHODS	This retrospective study included 33 patients ( male-female ratio , 19:14 ; mean age , 63.7 years ) who received total hip replacements and 20 patients who did not have metal prostheses as the control group .
METHODS	All of the patients underwent dual-energy CT. .
METHODS	The quality of the images reconstructed using the MAR algorithm and of those reconstructed using the standard reconstruction was evaluated in terms of the visibility of the bladder wall , pelvic sidewall , rectal shelf , and bone-prosthesis interface and the overall diagnostic image quality with a 4-point scale .
METHODS	The mean and SD attenuation values in Hounsfield units were measured in the bladder , pelvic sidewall , and rectal shelf .
METHODS	For validation of the MAR interpolation algorithm , pelvis phantoms with small bladder `` lesions '' and metal hip prostheses were made , and images of the phantoms both with and without MAR reconstruction were evaluated .
RESULTS	Image quality was significantly better with MAR reconstruction than without at all sites except the rectal shelf , where the image quality either had not changed or had worsened after MAR reconstruction .
RESULTS	The mean attenuation value was changed after MAR reconstruction to its original expected value at the pelvic sidewall ( p < 0.001 ) and inside the bladder ( p < 0.001 ) .
RESULTS	The SD attenuation value was significantly decreased after MAR reconstruction at the pelvic sidewall ( p = 0.019 ) but did not show significant differences at the bladder ( p = 0.173 ) or rectal shelf ( p = 0.478 ) .
RESULTS	In the phantom study , all lesions obscured by metal artifacts on the standard reconstruction images were visualized after MAR reconstruction ; however , new artifacts had developed in other parts of the MAR reconstruction images .
CONCLUSIONS	The use of MAR software with dual-energy CT decreases metal artifacts and increases diagnostic confidence in the assessment of the pelvic cavity but also introduces new artifacts that can obscure pelvic structures .

###24252050
OBJECTIVE	To obtain safety and efficacy data on combination treatment with iguratimod and methotrexate ( MTX ) in an open-label extension study in patients with active rheumatoid arthritis ( RA ) .
METHODS	Following a 28-week , randomized , double-blind trial of adding iguratimod or placebo to stable MTX therapy , patients entered a 24-week extension .
METHODS	Patients randomized to the iguratimod + MTX group continued treatment .
METHODS	Patients treated with placebo + MTX switched to iguratimod + MTX [ the ( placebo/iguratimod ) + MTX group ] .
RESULTS	In the iguratimod + MTX group , the rate of 20 % improvement in American College of Rheumatology criteria ( ACR20 ) at week 52 ( 71.3 % ) was similar to that at week 24 ( 69.5 % ) .
RESULTS	ACR50 , ACR70 and Health Assessment Questionnaire Disability Index at week 52 significantly improved compared with the values at week 24 .
RESULTS	In the ( placebo/iguratimod + MTX ) group , the switch to iguratimod treatment significantly improved ACR20 from 30.7 % at week 24 to 72.1 % at week 52 .
RESULTS	Frequent adverse events for 52 weeks in the iguratimod + MTX group were nasopharyngitis , upper respiratory tract inflammation , stomatitis , lymphocyte decrease , AST increase , ALT increase and blood iron decrease .
RESULTS	These adverse events were predominantly mild or moderate in severity .
RESULTS	No deaths occurred .
CONCLUSIONS	Efficacy and tolerance of iguratimod + MTX therapy was maintained to 52 weeks in patients with active RA with inadequate response to MTX .

###25198417
BACKGROUND	Bystander intervention approaches offer promise for reducing rates of sexual violence on college campuses .
BACKGROUND	Most interventions are in-person small-group formats , which limit their reach and reduce their overall public health impact .
OBJECTIVE	This study evaluated the efficacy of RealConsent , a Web-based bystander approach to sexual violence prevention , in enhancing prosocial intervening behaviors and preventing sexual violence perpetration .
METHODS	A random probability sample of 743 male undergraduate students ( aged 18 to 24 years ) attending a large , urban university located in the southeastern United States was recruited online and randomized to either RealConsent ( n = 376 ) or a Web-based general health promotion program ( n = 367 ) .
METHODS	Participants were surveyed online at baseline , postintervention , and 6-months postintervention .
METHODS	RealConsent was delivered via a password-protected Web portal that contained six 30-minute media-based and interactive modules covering knowledge of informed consent , communication skills regarding sex , the role of alcohol and male socialization in sexual violence , empathy for rape victims , and bystander education .
METHODS	Primary outcomes were self-reported prosocial intervening behaviors and sexual violence perpetration .
METHODS	Secondary outcomes were theoretical mediators ( eg , knowledge , attitudes ) .
RESULTS	At 6-month follow-up RealConsent participants intervened more often ( P = .04 ) and engaged in less sexual violence perpetration ( P = .04 ) compared to controls .
RESULTS	In addition , RealConsent participants reported greater legal knowledge of sexual assault ( P < .001 ) , greater knowledge of effective consent ( P < .001 ) , less rape myths ( P < .001 ) , greater empathy for rape victims ( P < .001 ) , less negative date rape attitudes ( P < .001 ) , less hostility toward women ( P = .01 ) , greater intentions to intervene ( P = .04 ) , less hyper-gender ideology ( P < .001 ) , less positive outcome expectancies for nonconsensual sex ( P = .03 ) , more positive outcome expectancies for intervening ( P < .001 ) , and less comfort with other men 's inappropriate behaviors ( P < .001 ) .
CONCLUSIONS	Our results support the efficacy of RealConsent .
CONCLUSIONS	Due to its Web-based format , RealConsent has potential for broad-based dissemination thereby increasing its overall public health impact on sexual violence .
BACKGROUND	Clinicaltrials.gov : NCT01903876 ; http://clinicaltrials.gov/show/NCT01903876 ( Archived by WebCite at http://www.webcitation.org/6S1PXxWKt ) .

###24667938
BACKGROUND	HIV spread rapidly among people who inject drugs in Bangkok in the late 1980s .
BACKGROUND	In recent years , changes in drug use and HIV-associated risk behaviors have been reported .
BACKGROUND	We examined data from the Bangkok Tenofovir Study , an HIV pre-exposure prophylaxis trial conducted among people who inject drugs , to assess participant risk behavior and drug use , and to identify risk factors for HIV infection .
METHODS	The Bangkok Tenofovir Study was a randomized , double-blind , placebo-controlled trial .
METHODS	HIV status was assessed monthly and risk behavior every 3 months .
METHODS	We used generalized estimating equations logistic regression to model trends of injecting , needle sharing , drugs injected , incarceration , and sexual activity reported at follow-up visits ; and proportional hazards models to evaluate demographic characteristics , sexual activities , incarceration , drug injection practices , and drugs injected during follow-up as predictors of HIV infection .
RESULTS	The proportion of participants injecting drugs , sharing needles , and reporting sex with more than one partner declined during follow-up ( p < 0.001 ) .
RESULTS	Among participants who reported injecting at enrollment , 801 ( 53.2 % ) injected methamphetamine , 559 ( 37.1 % ) midazolam , and 527 ( 35.0 % ) heroin .
RESULTS	In multivariable analysis , young age ( i.e. , 20-29 years ) ( p = 0.02 ) , sharing needles ( p < 0.001 ) , and incarceration in prison ( p = 0.002 ) were associated with incident HIV infection .
RESULTS	Participants reporting sex with an opposite sex partner , live-in partner , casual partner , or men reporting sex with male partners were not at a significantly higher risk of HIV infection compared to those who did not report these behaviors .
CONCLUSIONS	Reports of HIV-associated risk behavior declined significantly during the trial .
CONCLUSIONS	Young age , needle sharing , and incarceration were independently associated with HIV infection .
CONCLUSIONS	Sexual activity was not associated with HIV infection , suggesting that the reduction in HIV incidence among participants taking daily oral tenofovir compared to those taking placebo was due to a decrease in parenteral HIV transmission .

###25527750
BACKGROUND	In our published randomized , double-blind , placebo-controlled , 3-period crossover trial , healthy adult men ( n = 21 ) consumed bars containing no supplemental fiber ( placebo ; NFC ) , polydextrose ( 21 g/d ) , and soluble corn fiber ( SCF ; 21 g/d ) for 21 d each .
BACKGROUND	Fecal specimens were collected between days 16 and 21 for fermentative end-product analysis and 16S ribosomal RNA bacterial gene amplification for bacterial taxa identification .
BACKGROUND	Fiber supplementation decreased fecal putrefaction compounds and shifted abundances of several bacterial taxa .
OBJECTIVE	The objective was to perform whole-genome shotgun 454 pyrosequencing on the same fecal specimens collected in that clinical trial to obtain comprehensive fecal bacterial genome sequencing coverage and explore the full range of bacterial genetic information in the fecal microbiome , thereby using a systematic approach to study the impact of dietary fiber supplementation on fecal metabolites , bacterial taxa , and bacterial metagenomes .
METHODS	Fecal samples were subjected to whole-genome shotgun 454 pyrosequencing to identify both fecal bacterial populations present and their functional genetic capacity .
RESULTS	Whole-genome shotgun sequencing results revealed that fiber consumption shifted the Bacteroidetes : Firmicutes ratio , increasing the relative abundance of Bacteroidetes 12 2 % and 13 2 % with polydextrose and SCF , respectively , compared with NFC .
RESULTS	Bivariate correlations showed a positive correlation between the Bacteroidetes : Firmicutes ratio and total dietary fiber intake but not body mass index .
RESULTS	Principal coordinates analysis of Bray-Curtis distances indicated that bacterial gene composition was more similar in participants consuming fibers ( polydextrose and SCF combined ) in comparison with NFC .
RESULTS	Shifts in bacterial gene abundances after polydextrose and SCF supplementation included genes associated with carbohydrate , amino acid , and lipid metabolism , as well as metabolism of cofactors and vitamins .
CONCLUSIONS	This study conveys novel information about the impact of dietary fiber supplementation on the phylogenetic structure and functional capacity of the fecal microbiome of healthy adults .

###25487353
BACKGROUND	Intermediate care is intended to reduce hospital admissions and facilitate early discharge .
BACKGROUND	In Norway , a model was developed with transfer to intermediate care shortly after hospital admission .
BACKGROUND	Efficacy and safety of this model have not been studied previously.In a parallel-group randomized controlled trial , patients over 70 years living at home before admission were eligible if clinically stable , without need for surgical treatment and deemed suited for intermediate care by attending physician .
BACKGROUND	Intervention group patients were transferred to a nursing home unit with increased staff and multidisciplinary assessment , for a maximum stay of three weeks .
BACKGROUND	Patients in the control group received usual care in hospital .
BACKGROUND	Blinding to group assignment was not possible.The primary outcome was number of days living at home in a follow-up period of 365 days .
BACKGROUND	Secondary outcomes were mortality , hospital admissions , need for residential care and home care services .
BACKGROUND	Data were obtained from patient records and registers .
RESULTS	376 patients were included , 74 % female and mean age 84 years .
RESULTS	There was no significant differences between intervention ( n = 190 ) and control group ( n = 186 ) for number of days living at home ( 253.7 vs 256.5 , p = 0.80 ) or days in hospital ( 10.4 vs 10.5 , p = 0.748 ) .
RESULTS	Intervention group patients spent less time in nursing home ( 40.6 days vs. 55.0 , p = 0.046 ) , and more patients lived independently without home health care services ( 31.6 % vs 19.9 % , p = 0.007 ) .
RESULTS	For orthopaedic patients ( n = 128 ) , mortality was higher in the intervention group ; 15 intervention patients and 7 controls died ( 25.1 % vs 10.3 % , p = 0.049 ) .
RESULTS	There was no significant difference in one-year mortality for medical patients ( n = 150 ) or the total study population .
CONCLUSIONS	This model of rapid transfer to intermediate care did not significantly influence number of days living at home during one year follow-up , but reduced demand for nursing home care and need for home health care services .
CONCLUSIONS	In post-hoc analysis mortality was increased for orthopedic patients .
BACKGROUND	The trial was registered 26 .
BACKGROUND	July 2013 at Current Controlled Trials and assigned with registration number ISRCTN21608185 .

###24281361
BACKGROUND	Individuals with eating disorders show deficits in neuropsychological functioning which might preexist and underlie the etiology of the eating disorders and influence relapse .
BACKGROUND	Deficits in cognitive flexibility , i.e. , set-shifting and central coherence , might perpetuate the symptoms .
BACKGROUND	Cognitive remediation therapy ( CRT ) was developed to improve cognitive flexibility , thereby increasing the likelihood of improved outcome .
BACKGROUND	The focus of CRT is on how patients think , rather than on what patients think .
BACKGROUND	The present study investigated the effectiveness of CRT for patients with a severe or enduring eating disorder by means of a randomized controlled trial comparing intensive treatment as usual ( TAU ) to CRT plus TAU .
METHODS	Eighty-two patients were randomly assigned to CRT plus TAU ( n = 41 ) or TAU alone ( n = 41 ) .
METHODS	Outcome measures were set-shifting , central coherence , eating disorder and general psychopathology , motivation , quality of life and self-esteem .
METHODS	Assessments were performed at baseline ( n = 82 ) and after 6 weeks ( T1 ; n = 75 ) and 6 months ( T2 ; n = 67 ) .
METHODS	Data were analyzed by means of linear mixed model analyses .
RESULTS	Patients who received CRT in addition to TAU improved significantly more with regard to eating disorder-related quality of life at the end of treatment ( T1 ) and eating disorder psychopathology at follow-up ( T2 ) , compared to those who received TAU only .
RESULTS	Moreover , moderator analyses revealed that patients with poor baseline set-shifting abilities benefited more from CRT than patients with no deficits in set-shifting abilities at baseline ; the quality of life of the former group was higher than that of the latter at follow-up .
CONCLUSIONS	CRT seems to be promising in enhancing the effectiveness of concurrent treatment .

###25269863
BACKGROUND	Depression is one of the most common psychiatric illnesses worldwide , but is nevertheless preventable .
BACKGROUND	Since the children of parents who have depression are at greatest risk of developing depression themselves , prevention programmes for this population are a major public health priority .
BACKGROUND	Here we report the study protocol of a randomised controlled trial of a group-based psychological intervention for families with i ) at least one parent who suffers ( or has suffered ) from depression and ii ) at least one child who has no current or previous psychiatric diagnosis .
METHODS	Eligible families will be randomly allocated to receive either a German adaptation of the 12-session cognitive-behavioural Raising Healthy Children intervention ( Gesund und glcklich aufwachsen ; N = 50 ) , or no intervention ( usual care ; N = 50 ) .
METHODS	The primary outcome ( child diagnosis of an episode of depression ) will be assessed at 15-month follow-up .
METHODS	The secondary outcomes ( child psychopathological symptoms ) will be assessed immediately following completion of the intervention ( 6-months ) , as well as at 9 - and 15-month follow-up .
METHODS	We hypothesise that children in the intervention condition , compared with those who do not receive the intervention , will show fewer symptoms of psychopathology , and be less likely to meet diagnostic criteria for a depressive episode , at follow-up .
CONCLUSIONS	Despite their elevated risk of developing depression , there is little formal support available for the children of parents with depression .
CONCLUSIONS	This study provides an important step in the development of more effective depression prevention measures , which are needed if the personal , social and economic burden of depression is to be reduced .
BACKGROUND	Clinical Trials NCT02115880 .
BACKGROUND	Registered April 7 2014 .

###25522681
BACKGROUND	The choice of anaesthetic technique for patients undergoing joint arthroplasty is debatable .
BACKGROUND	The hypothesis of this study was that general anaesthesia would generate a more favourable recovery profile than spinal anaesthesia .
METHODS	We randomly allocated 120 patients to either intrathecal bupivacaine or general anaesthesia with target-controlled infusion of remifentanil and propofol .
METHODS	Length of hospital stay assessed as meeting discharge criteria was the primary outcome parameter .
METHODS	Other outcome parameters were actual time of discharge , pain , use of rescue pain medication , blood loss , length of stay in the post-operative care unit , dizziness , post-operative nausea , need of urinary catheterisation and patient satisfaction .
RESULTS	General anaesthesia resulted in slightly reduced length of hospital stay ( 26 vs. 30h , P = 0.004 ) , less nausea ( P = 0.043 ) and dizziness ( P < 0.001 ) .
RESULTS	General anaesthesia patients had higher pain scores during the first two post-operative hours ( P < 0.001 ) but lower after 6h compared with the spinal anaesthesia group ( P < 0.01 and P < 0.05 ) .
RESULTS	General anaesthesia patients had better orthostatic function compared with spinal anaesthesia patients ( P = 0.008 ) .
RESULTS	Patients in the spinal anaesthesia group fulfilled the discharge criteria from the post-operative care unit earlier compared with the general anaesthesia patients ( P = 0.004 ) .
RESULTS	General anaesthesia patients requested a change in the method of anaesthesia for a subsequent operation less often than the spinal anaesthesia patients ( 5 vs. 13 , P = 0.022 ) .
CONCLUSIONS	General anaesthesia resulted in a more favourable recovery profile compared with spinal anaesthesia .

###25811584
BACKGROUND	Why do limb tourniquets cause pain ?
BACKGROUND	If ischemia is the mechanism , can supplemental oxygen reduce pain ?
BACKGROUND	The Reducing Tourniquet Associated Pain study investigated whether this simple treatment could extend tourniquet tolerance time to facilitate hand surgery under local or regional anesthesia .
METHODS	The Reducing Tourniquet Associated Pain study was a double-blind , randomized , controlled trial of healthy volunteers .
METHODS	Participants received either 50 % inhaled oxygen or air placebo via a face mask for 3 minutes before and up to 30 minutes after upper arm tourniquet inflation to 250 mmHg .
METHODS	Pain scores were recorded at 2-minute intervals using a validated 100-mm visual analogue scale .
METHODS	The primary outcomes were ( 1 ) difference in visual analogue scale score and ( 2 ) difference in time taken to reach visual analogue score of 40 mm or more in oxygen and air groups .
RESULTS	Fifty participants enrolled and , after exclusion criteria were applied , 46 were analyzed ( oxygen , n = 23 ; air , n = 23 ) .
RESULTS	Oxygen supplementation was associated with a 29 percent mean reduction in pain on visual analogue scoring compared with air placebo over the entire period of inhalation ( p = 0.027 ) .
RESULTS	Oxygen also extended the time to visual analogue scale score of 40 mm or more by a mean of 6 minutes compared with air placebo ( p = 0.008 ) .
CONCLUSIONS	Oxygen is a readily available , low-risk , low-cost treatment that significantly reduced tourniquet-associated pain in this study and significantly increased the time taken to reach visual analogue scale score of 40 or more .
CONCLUSIONS	The authors recommend oxygen to facilitate hand surgery under a tourniquet and when a regional block fails to control tourniquet pain .

###24581322
BACKGROUND	Pruritus is the hallmark clinical sign of atopic dermatitis ( AD ) in dogs .
BACKGROUND	Preliminary study results suggest that oclacitinib , a selective Janus kinase inhibitor , could reduce pruritus and associated inflammatory skin lesions in dogs with AD .
OBJECTIVE	The objective was to evaluate efficacy and safety of oclacitinib ( Apoquel ) for the control of AD in a randomized , double-blind , placebo-controlled trial .
METHODS	Clinicians at 18 specialty clinics enrolled client-owned dogs ( n = 299 ) with a history of chronic AD .
METHODS	Dogs were randomized to receive either oclacitinib ( 0.4-0 .6 mg/kg twice daily for 14 days and then once daily for up to 112 days ) or an excipient-matched placebo .
METHODS	Owners assessed visual analog scale ( VAS ) scores of pruritus on days 0 , 1 , 2 , 7 , 14 , 28 , 56 , 84 and 112 .
METHODS	Clinicians assessed Canine AD Extent and Severity Index ( CADESI-02 ) scores on days 0 , 14 , 28 , 56 , 84 and 112 .
RESULTS	On days 1 , 2 , 7 , 14 and 28 , oclacitinib-treated dogs had a 29.5 , 42.3 , 61.5 , 66.7 and 47.4 % reduction from baseline in owner-assessed pruritus scores , respectively , compared with a 6.5 , 9.1 , 6.5 , 3.9 and 10.4 % reduction in placebo-treated dogs .
RESULTS	On days 14 and 28 , dermatologists recorded a 48.4 % reduction in CADESI-02 scores in oclacitinib-treated dogs compared with a 1.7 % reduction and a 3.6 % increase in placebo-treated dogs .
RESULTS	After day 28 , > 86 % of all placebo-treated dogs had moved to an open-label study , making between-group comparisons biased .
RESULTS	Differences were significant at all time points assessed ( P < 0.0001 ) .
CONCLUSIONS	Oclacitinib provided rapid , effective and safe control of AD , with substantial improvement in VAS and CADESI-02 scores .

###24702571
BACKGROUND	Systemic administration of dexmedetomidine has been shown to reduce opioid consumption and improve analgesia satisfaction .
BACKGROUND	The purpose of this study was to investigate the effect of intrathecal dexmedetomidine on spinal morphine analgesia in patients with refractory cancer pain .
METHODS	A double-blinded crossover study was designed and performed .
METHODS	Patients were randomly allocated in one of the two phases .
METHODS	Phase M received intrathecal morphine administration .
METHODS	Phase M+D received intrathecal morphine plus dexmedetomidine administration .
METHODS	All patients were monitored for 7 days and crossed over to alternate phase for another 1-week observation .
METHODS	Daily average visual analog scale ( VAS ) pain score , pain frequency , sleep deprivation , daily morphine consumption , bolus dose injection times , and side effects were all recorded .
RESULTS	Pain intensity and frequency were significantly decreased in both phases compared with baseline .
RESULTS	Daily morphine consumption and bolus dose injection times during phase M+D were significantly decreased compared with phase M.
RESULTS	The incidences of constipation were significantly reduced in both phases compared with baseline administration , but nausea and vomiting were significantly increased .
RESULTS	No serious side effects such as respiratory inhibition were observed in this study .
CONCLUSIONS	Intrathecal administration of dexmedetomidine and morphine reduced the morphine consumption in patients with refractory cancer pain .
CONCLUSIONS	There were no serious side effects .

###24461278
OBJECTIVE	With little scientific evidence to support use of aromatherapy for postoperative nausea and/or vomiting ( PONV ) symptoms , this study evaluated controlled breathing with peppermint aromatherapy ( AR ) and controlled breathing alone ( CB ) for PONV relief .
METHODS	A single blind randomized control trial design was used .
METHODS	On initial PONV complaint , symptomatic subjects received either CB ( n = 16 ) or AR ( n = 26 ) intervention based on randomization at enrollment .
METHODS	A second treatment was repeated at 5 minutes if indicated .
METHODS	Final assessment occurred 10 minutes post initial treatment .
METHODS	Rescue medication was offered for persistent symptoms .
RESULTS	Among eligible subjects , PONV incidence was 21.4 % ( 42/196 ) .
RESULTS	Gender was the only risk factor contributing to PONV symptoms ( P = .0024 ) .
RESULTS	Though not statistically significant , CB was more efficacious than AR , 62.5 % versus 57.7 % , respectively .
CONCLUSIONS	CB can be initiated without delay as an alternative to prescribed antiemetics .
CONCLUSIONS	Data also support use of peppermint AR in conjunction with CB for PONV relief .

###24285635
BACKGROUND	This randomized crossover trial aimed to compare the effects of 2 different protocols using pedometers and informative booklets to increase physical activity in daily life ( PADL ) in smokers .
METHODS	PADL level was assessed at baseline ( A1 ) , and subjects were randomly assigned to 2 groups for a month : booklet + pedometer ( GB + P ; n = 13 ) , which started the protocol receiving a booklet with encouragement to walk as much as possible in everyday life ; pedometer + booklet ( GP + B ; n = 18 ) , which started the protocol wearing a pedometer aiming to achieve 10,000 steps/day .
METHODS	PADL was reassessed ( A2 ) , and the interventions were crossed over for 1 month , followed by PADL reassessment ( A3 ) .
METHODS	After A3 , both groups used pedometers for 3 months aiming to reach 10,000 steps/day , and final PADL assessment was performed ( A4 ) .
METHODS	For the analysis , each group was subdivided according to baseline PADL as physically active or inactive , according to having reached or not reached 10,000 steps/day at baseline .
RESULTS	The physically active subgroups of GB + P and GP + B showed no change in steps/day .
RESULTS	The physically inactive subgroup of GP + B significantly increased steps/day at A2 and maintained this increase until A4 .
RESULTS	The physically inactive subgroup of GB + P initially increased to a lesser extent , reaching borderline statistical significance at A2 and A3 ( p = .06 ) and statistically significant increase only at A4 ( p = .02 ) .
CONCLUSIONS	Both strategies were effective in increasing the number of steps/day in physically inactive smokers after 5 months , although the increase was more quickly obtained in smokers who used pedometers as the first intervention .

###25301853
OBJECTIVE	To clarify the effectiveness of second-look endoscopy ( SLE ) at preventing bleeding after gastric endoscopic submucosal dissection ( ESD ) .
METHODS	A multicentre prospective randomised controlled non-inferiority trial was conducted at five referral institutions across Japan .
METHODS	Patients with a solitary gastric neoplasm were enrolled .
METHODS	Exclusion criteria were previous oesophagogastric surgery or radiation therapy ; perforation and the administration of antithrombotics , steroids or non-steroidal anti-inflammatory drugs .
METHODS	Patients were assigned to the SLE group or the non-SLE group by a computer-generated random sequence after ESD and were treated perioperatively with a proton pump inhibitor .
METHODS	SLE was performed one day after ESD .
METHODS	The primary endpoint was post-ESD bleeding , defined as an endoscopically proven haemorrhage .
METHODS	The trial had the power to detect a non-inferiority criterion of 7 % between the groups .
RESULTS	From February 2012 to February 2013 , 130 and 132 patients were assigned to the SLE and the non-SLE groups , respectively .
RESULTS	All patients were included in the intention-to-treat analysis of the primary endpoint .
RESULTS	Post-ESD bleeding occurred in seven patients with ( 5.4 % ) SLE and five patients with ( 3.8 % ) non-SLE ( risk difference -- 1.6 % ( 95 % CI -6.7 to 3.5 ) ; pnon-inferiority < 0.001 ) , meeting the non-inferiority criterion .
RESULTS	All 12 patients with post-ESD bleeding and one patient with a delayed perforation were successfully managed with conservative treatment .
CONCLUSIONS	SLE after gastric ESD is not routinely recommended because it does not contribute to the prevention of post-ESD bleeding for patients with an average bleeding risk .
BACKGROUND	UMIN-CTR000007170 .

###25087079
BACKGROUND	The response of diastolic Doppler indices to exercise is not well defined for young subjects .
BACKGROUND	The aims of this study were to evaluate this in nonathletic and endurance-trained probands and to correlate echocardiographic data with maximal oxygen consumption .
METHODS	In this prospective study , Doppler echocardiography was performed at rest and after exercise in 40 nonathletes ( NAs ) and 20 endurance-trained athletes ( ETs ) aged < 40 years , matched for age and gender .
METHODS	Diastolic function was assessed by mitral inflow and early diastolic velocities of the septal ( e ' septal ) and lateral ( e ' lateral ) mitral annulus .
METHODS	Maximal oxygen consumption quantification was performed simultaneously .
RESULTS	All cardiac chambers were larger in ETs than NAs .
RESULTS	ETs had higher e ' lateral at rest ( 18.1 2.7 vs 16.3 3.3 cm/sec , P = .02 ) and higher mitral E ( 141 15 vs 132 15 cm/sec , P = .02 ) and e ' lateral ( 23.5 2.5 vs 21.4 3.0 cm/sec , P = .01 ) with exercise than NAs .
RESULTS	There was a slight increase in E/e ' septal ( overall , from 6.8 1.3 to 7.2 1.2 ; P = .02 ) and E/e ' lateral ( overall , from 5.0 0.8 to 6.2 0.9 ; P < .0001 ) with exercise .
RESULTS	Changes in diastolic parameters with exercise were similar in ETs and NAs .
RESULTS	Percentage of predicted maximal oxygen consumption was correlated with exertional E ( r = 0.28 , P = .03 ) and e ' lateral ( r = 0.32 , P = .01 ) , but the strongest predictor was indexed left ventricular end-diastolic volume ( r = 0.66 , P < .0001 ) .
CONCLUSIONS	During exercise , E/e ' increases but remains within normal ranges in healthy young subjects , and the response to exercise does not differ between ETs and NAs .
CONCLUSIONS	These data help define the normal diastolic stress echocardiographic response in the young .
CONCLUSIONS	Exercise capacity shows a correlation with enhanced exertional early diastolic velocities but is more closely related to cardiac structural adaption to endurance training .

###24909530
BACKGROUND	Concept maps have been used to promote meaningful learning and critical thinking .
BACKGROUND	Although these are crucially important in all disciplines , evidence for the benefits of concept mapping for learning in medicine is limited .
METHODS	We performed a randomised crossover study to assess the benefits of online testable concept maps for learning in pathology by volunteer junior medical students .
METHODS	Participants ( n = 65 ) were randomly allocated to either of two groups with equivalent mean prior academic performance , in which they were given access to either online maps or existing online resources for a 2-week block on renal disease .
METHODS	Groups then crossed over for a 2-week block on hepatic disease .
METHODS	Outcomes were assessed using timed online quizzes , which included questions unrelated to topics in the pathogenesis maps as an internal control .
METHODS	Questionnaires were administered to evaluate students ' acceptance of the maps .
RESULTS	In both blocks , the group with access to pathogenesis maps achieved significantly higher average scores than the control group on quiz questions related to topics covered by the maps ( Block 1 : p < 0.001 , Cohen 's d = 0.9 ; Block 2 : p = 0.008 , Cohen 's d = 0.7 ) .
RESULTS	However , mean scores on unrelated questions did not differ significantly between the groups .
RESULTS	In a third block on pancreatic disease , both groups received pathogenesis maps and collectively performed significantly better on quiz topics related to the maps than on unrelated topics ( p < 0.01 , Cohen 's d = 0.5 ) .
RESULTS	Regression analysis revealed that access to pathogenesis maps was the dominant contributor to variance in performance on map-related quiz questions .
RESULTS	Responses to questionnaire items on pathogenesis maps were overwhelmingly positive in both groups .
CONCLUSIONS	These results indicate that online testable pathogenesis maps are well accepted and can improve learning of concepts in pathology by medical students .

###25515276
OBJECTIVE	Positional therapy ( PT ) is an effective therapy in positional obstructive sleep apnea syndrome ( POSAS ) when used , but the compliance of PT is low .
OBJECTIVE	The objective of this study was to investigate whether a new kind of PT is effective and can improve compliance .
METHODS	29 patients were treated with the Sleep Position Trainer ( SPT ) , 26 patients with the Tennis Ball Technique ( TBT ) .
METHODS	At baseline and 1 month polysomnography , Epworth Sleepiness Scale ( ESS ) and the Quebec Sleep Questionnaire ( QSQ ) were taken .
METHODS	Daily compliance was objectively measured in both groups .
RESULTS	Both therapies prevent supine sleep position to a median of 0 % ( min-max : SPT 0.0 % to 67 % , TBT 0.0 % to 38.9 % ) , resulting in a treatment success ( AHI < 5 ) in 68.0 % of the SPT and 42.9 % of the TBT patients .
RESULTS	The ESS at baseline was < 10 in both groups .
RESULTS	Sleep quality parameters as wake after sleep onset ( WASO ; p = 0.001 ) and awakenings ( p = 0.006 ) improved more in the SPT group .
RESULTS	Total QSQ scores ( 0.40.2 , p = 0.03 ) and the QSQ domains nocturnal symptoms ( 0.70.2 , p = 0.01 ) and social interactions ( 0.80.3 , p = 0.02 ) changed in favor of the SPT group .
RESULTS	Effective compliance ( 4 h/night + 5 days/week ) was 75.9 % for the SPT and 42.3 % for the TBT users ( p = 0.01 ) .
CONCLUSIONS	In mild POSAS with normal EES the new SPT device and the standard TBT are equally effective in reducing respiratory indices .
CONCLUSIONS	However , compared to the TBT , sleep quality , quality of life , and compliance improved significantly more in the SPT group .

###24503762
BACKGROUND	Uric acid has been linked to the progression of native kidney disease .
BACKGROUND	Studies evaluating its contribution to allograft function in kidney transplant recipients , among whom hyperuricemia is common , have yielded mixed results .
METHODS	We evaluated the association between baseline uric acid and the primary composite outcome of doubling of interstitium or ESRD from interstitial fibrosis and tubular atrophy ( IF/TA ) in the Angiotensin II Blockade for Chronic Allograft Nephropathy ( ABCAN ) Trial participants .
METHODS	Subjects underwent uric acid , iothalamte GFR , and urine albumin to creatinine ( ACR ) measurements annually for 5 years in addition to an allograft biopsy at baseline and 5 years .
RESULTS	Baseline uric acid was 5.571.48 mg/dL ; male sex , higher BMI , diuretic use , and lower GFR were associated with higher uric acid , whereas older age , less than 3 HLA matches and having a female donor were associated with lower levels .
RESULTS	In multivariate analysis adjusting for baseline GFR , uric acid was associated with doubling of interstitium or ESRD from IF/TA ( OR 1.83 , 95 % CI , 1.06-3 .17 , P = 0.03 ) .
RESULTS	Over time , a 1 mg/dL increase in time-varying uric acid was associated with a 2.39 mL/min lower final GFR ( P < 0.001 ) but not with the secondary outcome of creatinine doubling , ESRD , or death .
CONCLUSIONS	These data suggest that uric acid is associated with IF/TA and thus may be a viable target for intervention .

###25162332
BACKGROUND	Most orthodontists believe that fixed retainers are necessary to maintain ideal dental relationships .
BACKGROUND	However , untoward side effects might result from their long-term placement .
BACKGROUND	The aim of this study was to evaluate the clinical and radiographic effect of two commonly used fixed retainers on the health of the periodontium .
METHODS	Thirty patients were randomly divided into two groups to receive either a fiber-reinforced composite retainer or a spiral wire retainer extended on the lingual surfaces of both maxillary and mandibular arches from canine to canine .
METHODS	Periapical radiographs were obtained from the patients at the time of placement of the retainers and after the 6-month period to assess the radiographic conditions of the periodontium .
METHODS	Clinical examination was carried out at the same two time intervals .
RESULTS	Even though there were no significant differences between the two groups of study at the beginning of the trial , there were statistically significant differences after the 6-month follow-up regarding the main outcomes of the study .
RESULTS	Nearly all indices showed to deteriorate after 6 months in the fiber-reinforced group , while in the spiral wire group , this was not the case .
RESULTS	As for the secondary outcomes , radiographic examination did not reveal any statistically significant differences after 6 months or between the two groups .
CONCLUSIONS	It can be concluded that spiral wire retainers elicit less detrimental periodontal response in the short-term follow-up compared to fiber-reinforced composite retainers as revealed by the primary outcomes of the study .
BACKGROUND	ClinicalTrials.gov : NCT01314729 .

###25733633
BACKGROUND	Muscle weakness and fatigue are common symptoms in multiple sclerosis ( MS ) .
BACKGROUND	Green tea catechins such as ( - ) epigallocatechin-3-gallate ( EGCG ) are known to improve energy metabolism at rest and during exercise .
OBJECTIVE	We tested the hypothesis that EGCG improves energy metabolism and substrate utilization in patients with MS.
METHODS	Eighteen patients ( 8 men ) with relapsing-remitting MS ( expanded disability status scale score < 4.5 , all receiving glatiramer acetate ) participated in this randomized , double-blind , placebo-controlled , crossover trial at a clinical research center .
METHODS	All patients received EGCG ( 600 mg/d ) and placebo over 12 wk ( 4-wk washout in between ) .
METHODS	After each intervention , fasting and postprandial energy expenditure ( EE ) , as well as fat oxidation ( FAOx ) and carbohydrate oxidation ( CHOx ) rates , were measured either at rest or during 40 min of exercise ( 0.5 W/kg ) .
METHODS	At rest , blood samples and microdialysates from adipose tissue and skeletal muscle were also taken .
RESULTS	At rest , postprandial EE and CHOx , as well as adipose tissue perfusion and glucose supply , were significantly lower in men but higher in women receiving EGCG compared with placebo .
RESULTS	During exercise , postprandial EE was lower after EGCG than after placebo , indicating an increased working efficiency ( men > women ) .
RESULTS	After placebo , exercise EE was mainly fueled by FAOx in both men and women .
RESULTS	After EGCG , there was a shift to a higher and more stable CHOx during exercise in men but not in women .
CONCLUSIONS	Our data indicate that EGCG given to patients with MS over 12 wk improves muscle metabolism during moderate exercise to a greater extent in men than in women , possibly because of sex-specific effects on autonomic and endocrine control .

###24349496
BACKGROUND	Observational evidence suggests that improving fetal growth may improve adult health .
BACKGROUND	Experimental evidence from nutritional supplementation trials undertaken amongst pregnant women in the less developed world does not show strong or consistent effects on adult disease risk and no trials from the more developed world have previously been reported .
OBJECTIVE	To test the hypothesis that nutritional supplementation during pregnancy influences offspring disease risk in adulthood .
METHODS	Clinical assessment of a range of established diseases risk markers in young adult offspring of 283 South Asian mothers who participated in two trials of nutritional supplementation during pregnancy ( protein/energy/vitamins ; energy/vitamins or vitamins only ) at Sorrento Maternity Hospital in Birmingham UK either unselected or selected on the basis of nutritional status .
RESULTS	236 ( 83 % ) offspring were traced and 118 ( 50 % ) of these were assessed in clinic .
RESULTS	Protein/energy/vitamins supplementation amongst undernourished mothers was associated with increased infant birthweight .
RESULTS	Nutritional supplementation showed no strong association with any one of a comprehensive range of markers of adult disease risk and no consistent pattern of association with risk across markers in offspring of either unselected or undernourished mothers .
CONCLUSIONS	We found no evidence that nutritional supplements given to pregnant women are an important influence on adult disease risk however our study lacked power to estimate small effects .
CONCLUSIONS	Our findings do not provide support for a policy of nutritional supplementation for pregnant women as an effective means to improve adult health in more developed societies .

###24622121
OBJECTIVE	Impaired cardiac isoform of sarco ( endo ) plasmic reticulum Ca ( 2 + ) ATPase ( SERCA2a ) activity is a key abnormality in heart failure patients with reduced ejection fraction .
OBJECTIVE	The CUPID 2 ( Calcium Up-Regulation by Percutaneous Administration of Gene Therapy in Cardiac Disease Phase 2b ) trial is designed to evaluate whether increasing SERCA2a activity via gene therapy improves clinical outcome in these patients .
BACKGROUND	Intracoronary delivery of recombinant adeno-associated virus serotype 1 ( AAV1 ) / SERCA2a improves intracellular Ca ( 2 + ) handling by increasing SERCA2a protein levels and , as a consequence , restores systolic and diastolic function .
BACKGROUND	In a previous phase 2a trial , this therapy improved symptoms , functional status , biomarkers , and left ventricular function , and reduced cardiovascular events in advanced heart failure patients .
METHODS	CUPID 2 is a phase 2b , double-blind , placebo-controlled , multinational , multicenter , randomized event-driven study in up to 250 patients with moderate-to-severe heart failure with reduced ejection fraction and New York Heart Association functional class II to IV symptoms despite optimal therapy .
METHODS	Enrolled patients will be at high risk for recurrent heart-failure hospitalizations by virtue of having elevated N-terminal pro-B-type natriuretic peptide/BNP ( > 1,200 pg/ml , or > 1,600 pg/ml if atrial fibrillation is present ) and/or recent heart failure hospitalization .
METHODS	The primary endpoint of time-to-recurrent event ( heart failure-related hospitalizations in the presence of terminal events [ all-cause death , heart transplant , left ventricular assist device implantation or ambulatory worsening heart failure ] ) will be assessed using the joint frailty model .
METHODS	This ongoing trial is expected to complete recruitment in 2014 , with the required number of 186 recurrent events estimated to occur by mid 2015 .
RESULTS	Available data indicate that calcium up-regulation by AAV1/SERCA2a gene therapy is safe and of potential benefit in advanced heart failure patients .
CONCLUSIONS	The CUPID 2 trial is designed to study the effects of this therapy on clinical outcome in these patients .
CONCLUSIONS	( Calcium Up-Regulation by Percutaneous Administration of Gene Therapy in Cardiac Disease Phase 2b [ CUPID-2b ] ; NCT01643330 ) .

###24727329
OBJECTIVE	The EGF receptor ( EGFR ) and COX2 pathways are upregulated in head and neck squamous cell carcinoma ( HNSCC ) .
OBJECTIVE	Preclinical models indicate synergistic antitumor activity from dual blockade .
OBJECTIVE	We conducted a randomized , double-blind , placebo-controlled window trial of erlotinib , an EGFR inhibitor ; erlotinib plus sulindac , a nonselective COX inhibitor ; versus placebo .
METHODS	Patients with untreated , operable stage II-IVb HNSCC were randomized 5:5:3 to erlotinib , erlotinib-sulindac , or placebo .
METHODS	Tumor specimens were collected before and after seven to 14 days of treatment .
METHODS	The primary endpoint was change in Ki67 proliferation index .
METHODS	We hypothesized an ordering effect in Ki67 reduction : erlotinib-sulindac > erlotinib > placebo .
METHODS	We evaluated tissue microarrays by immunohistochemistry for pharmacodynamic modulation of EGFR and COX2 signaling intermediates .
RESULTS	From 2005-2009 , 47 patients were randomized for the target 39 evaluable patients .
RESULTS	Thirty-four tumor pairs were of sufficient quality to assess biomarker modulation .
RESULTS	Ki67 was significantly decreased by erlotinib or erlotinib-sulindac ( omnibus comparison , two-sided Kruskal-Wallis , P = 0.04 ) .
RESULTS	Wilcoxon pairwise contrasts confirmed greater Ki67 effect in both erlotinib groups ( erlotinib-sulindac vs. placebo , P = 0.043 ; erlotinib vs. placebo , P = 0.027 ) .
RESULTS	There was a significant trend in ordering of Ki67 reduction : erlotinib-sulindac > erlotinib > placebo ( two-sided exact Jonckheere-Terpstra , P = 0.0185 ) .
RESULTS	Low baseline pSrc correlated with greater Ki67 reduction ( R ( 2 ) = 0.312 , P = 0.024 ) .
CONCLUSIONS	Brief treatment with erlotinib significantly decreased proliferation in HNSCC , with additive effect from sulindac .
CONCLUSIONS	Efficacy studies of dual EGFR-COX inhibition are justified .
CONCLUSIONS	pSrc is a potential resistance biomarker for anti-EGFR therapy , and warrants investigation as a molecular target .

###24968210
OBJECTIVE	This study was conducted to determine whether installation of sit-stand desks ( SSDs ) could lead to decreased sitting time during the workday among sedentary office workers .
METHODS	A randomized cross-over trial was conducted from January to April , 2012 at a business in Minneapolis .
METHODS	28 ( nine men , 26 full-time ) sedentary office workers took part in a 4 week intervention period which included the use of SSDs to gradually replace 50 % of sitting time with standing during the workday .
METHODS	Physical activity was the primary outcome .
METHODS	Mood , energy level , fatigue , appetite , dietary intake , and productivity were explored as secondary outcomes .
RESULTS	The intervention reduced sitting time at work by 21 % ( 95 % CI 18 % -25 % ) and sedentary time by 4.8 min/work-hr ( 95 % CI 4.1-5 .4 min/work-hr ) .
RESULTS	For a 40 h work-week , this translates into replacement of 8 h of sitting time with standing and sedentary time being reduced by 3.2 h. Activity level during non-work hours did not change .
RESULTS	The intervention also increased overall sense of well-being , energy , decreased fatigue , had no impact on productivity , and reduced appetite and dietary intake .
RESULTS	The workstations were popular with the participants .
CONCLUSIONS	The SSD intervention was successful in increasing work-time activity level , without changing activity level during non-work hours .

###24361322
OBJECTIVE	This study sought to determine whether red blood cell ( RBC ) transfusion increases in vivo platelet aggregation and inflammation in coronary and noncoronary patients .
BACKGROUND	RBC transfusion increases in vitro platelet activation and aggregation in healthy volunteers , providing a possible explanation for the increase in recurrent ischemic events and mortality reported after RBC transfusion in patients with acute coronary syndromes ( ACS ) .
METHODS	Platelet reactivity was measured before and after RBC transfusion in 61 patients ( 33 with ACS patients and 28 without ACS ) .
METHODS	Relative changes between baseline and post-transfusion measurements of maximal and residual platelet aggregation were considered with different agonists as well as changes in vasodilator-stimulated phosphoprotein platelet reactivity index and P-selectin expression .
METHODS	Inflammatory and thrombotic biomarkers were also measured before and after transfusion .
RESULTS	After RBC transfusion , platelet reactivity was increased when measured using adenosine diphosphate-induced light transmission aggregometry ( 11.6 % relative increase in maximal platelet aggregation , p = 0.004 ; 10.8 % increase in residual platelet aggregation , p = 0.005 ) and vasodilator-stimulated phosphoprotein platelet reactivity index ( 20.7 % relative increase , p = 0.002 ) , and there was a nonsignificant trend toward an increase in P-selectin expression .
RESULTS	Similar results were found with the nonspecific agonist thrombin receptor-activated peptide ( relative increases of 11.7 % for maximal platelet aggregation , p = 0.04 , and 12.7 % for residual platelet aggregation , p = 0.02 ) but not with collagen or arachidonic acid agonists .
RESULTS	There were no significant differences in inflammatory and thrombotic biomarkers before and after transfusion .
CONCLUSIONS	After RBC transfusion , there is an increase in platelet reactivity , especially with tests measuring the adenosine diphosphate-P2Y12 receptor pathway , without significant variations in inflammatory or thrombotic biomarkers .
CONCLUSIONS	This in vivo effect may account for the excess of ischemic events observed in the context of patients with ACS treated using percutaneous coronary intervention and P2Y12 inhibitors .

###24642779
OBJECTIVE	To evaluate the short-term digestive tolerance and glycaemic response of several associations of maltitol and short-chain fructo-oligosaccharides ( scFOS ) used to replace sugars ( for example , dextrose ) in foods .
METHODS	Thirty-six healthy subjects aged 18-60 years were recruited for the study and 32 completed it .
METHODS	The subjects consumed six different mixtures of dextrose , maltitol and scFOS added in a chocolate dairy dessert at a dosage of 35g .
METHODS	The test days were separated by 2-week washout periods .
METHODS	The subjects reported the intensity of four individual gastrointestinal ( GI ) symptoms , number of bowel movements and stool frequency for the 48h following consumption of the dessert .
METHODS	A subgroup of 18 subjects also provided blood samples 2h after intake to evaluate the postprandial glycaemic and insulinaemic responses .
RESULTS	The composite score calculated from the intensity of flatulence , borborygmi , bloating and discomfort was significantly higher ( P < 0.0001 ) for all the desserts containing maltitol and/or scFOS than for the control dessert containing dextrose , but remains at the level of mild effects .
RESULTS	The number of bowel movements was also slightly increased ( P = 0.0006 ) and the stools were softer ( P = 0.0045 ) for the first 24h but not after ( P = 0.1373 and 0.5420 , respectively ) .
RESULTS	Blood glycaemic and insulinaemic responses were lower for all the sugar-free recipes containing maltitol and scFOS in comparison to the control one ( P < 0.0001 ) .
CONCLUSIONS	This study has shown that maltitol and scFOS can be used jointly when formulating sugar-free foods with the benefit to lower postprandial glycaemic response with only a small and transient increase in non-serious GI symptoms .

###24291193
BACKGROUND	Endemic malaria and helminth infections in sub-Saharan Africa can act as immunological modulators and impact responses to standard immunizations .
BACKGROUND	We conducted a cohort study to measure the influence of malaria and helminth infections on the immunogenicity of the bivalent HPV-16 / 18 vaccine .
METHODS	We evaluated the association between malaria and helminth infections , and HPV-16 / 18 antibody responses among 298 Tanzanian females aged 10-25 years enrolled in a randomized controlled trial of the HPV-16 / 18 vaccine .
METHODS	Malaria parasitaemia was diagnosed by examination of blood smears , and helminth infections were diagnosed by examination of urine and stool samples , respectively .
METHODS	Geometric mean antibody titres ( GMT ) against HPV-16 / 18 antibodies were measured by enzyme-linked immunosorbent assay .
RESULTS	Parasitic infections were common ; one-third ( 30.4 % ) of participants had a helminth infection and 10.2 % had malaria parasitaemia .
RESULTS	Overall , the vaccine induced high HPV-16 / 18 GMTs , and there was no evidence of a reduction in HPV-16 or HPV-18 GMT at Month 7 or Month 12 follow-up visits among participants with helminths or malaria .
RESULTS	There was some evidence that participants with malaria had increased GMTs compared to those without malaria .
CONCLUSIONS	The data show high HPV immunogenicity regardless of the presence of malaria and helminth infections .
CONCLUSIONS	The mechanism and significance for the increase in GMT in those with malaria is unknown .

###24283388
BACKGROUND	Polymorphic light eruption ( PLE ) is the most common photodermatosis .
BACKGROUND	Little is known about the efficacy of systemic photoprotection provided by nutritional supplements in PLE patients .
OBJECTIVE	The purpose of this study was to assess efficacy of nutritional supplement containing lycopene , - carotene , and Lactobacillus johnsonii to diminish skin lesions induced by ` photoprovocation ' testing in PLE patients .
METHODS	In this randomized , placebo-controlled , double-blinded study , 60 PLE patients were supplemented with the nutritional supplement or placebo .
METHODS	For inducing skin lesions , patient skin was exposed to single daily doses of 100J/cm2 ultraviolet A1 ( UVA1 ) for two consecutive days .
METHODS	Skin lesions were evaluated using a PLE score .
METHODS	Skin biopsies were taken before and after supplementation from unexposed and exposed skin , and intercellular adhesion molecule 1 ( ICAM-1 ) mRNA expression was assessed by real-time polymerase chain reaction .
RESULTS	Prior to supplementation , skin lesions were induced in all patients with comparable PLE scores .
RESULTS	After 12 weeks , intake of the supplement significantly reduced the PLE score after one exposure as compared with patients taking placebo ( P < 0.001 ) .
RESULTS	After two exposures , these differences were no longer significant .
RESULTS	At a molecular level , the development of skin lesions was associated with an increased expression of ICAM-1 mRNA , which was significantly reduced after supplementation ( P = 0.022 ) , but not with placebo .
CONCLUSIONS	The nutritional supplement provides protection against the development of UVA-induced PLE lesions at clinical and molecular levels .

###24369771
BACKGROUND	DECISION + 2 , a training program for physicians , is designed to implement shared decision making ( SDM ) in the context of antibiotics use for acute respiratory tract infections ( ARTIs ) .
BACKGROUND	We evaluated the impact of DECISION + 2 on SDM implementation as assessed by patients and physicians , and on physicians ' intention to engage in SDM .
METHODS	From 2010 to 2011 , a multi-center , two-arm , parallel randomized clustered trial appraised the effects of DECISION + 2 on the decision to use antibiotics for patients consulting for ARTIs .
METHODS	We randomized 12 family practice teaching units ( FPTUs ) to either DECISION + 2 or usual care .
METHODS	After the consultation , both physicians and patients independently completed questionnaires based on the D-Option scale regarding SDM behaviors during the consultation .
METHODS	Patients also answered items assessing the role they assumed during the consultation ( active/collaborative/passive ) .
METHODS	Before and after the intervention , physicians completed a questionnaire based on the Theory of Planned Behavior to measure their intention to engage in SDM .
METHODS	To account for the cluster design , we used generalized estimating equations and generalized linear mixed models to assess the impact of DECISION + 2 on the outcomes of interest .
RESULTS	A total of 270 physicians ( 66 % women ) participated in the study .
RESULTS	After DECISION + 2 , patients ' D-Option scores were 80.1 1.1 out of 100 in the intervention group and 74.9 1.1 in the control group ( p = 0.001 ) .
RESULTS	Physicians ' D-Option scores were 79.7 1.8 in the intervention group and 76.3 1.9 in the control group ( p = 0.2 ) .
RESULTS	However , subgroup analyses showed that teacher physicians D-Option scores were 79.7 1.5 and 73.0 1.4 respectively ( p = 0.001 ) .
RESULTS	More patients reported assuming an active or collaborative role in the intervention group ( 67.1 % ) , than in the control group ( 49.2 % ) ( p = 0.04 ) .
RESULTS	There was a significant relation between patients ' and physicians ' D-Option scores ( p < 0.01 ) and also between patient-reported assumed roles and both D-Option scores ( as assessed by patients , p < 0.01 ; and physicians , p = 0.01 ) .
RESULTS	DECISION + 2 had no impact on the intention of physicians to engage in SDM .
CONCLUSIONS	DECISION + 2 positively influenced SDM behaviors as assessed by patients and teacher physicians .
CONCLUSIONS	Physicians ' intention to engage in SDM was not affected by DECISION + 2 .
BACKGROUND	ClinicalTrials.gov trials register no .
BACKGROUND	NCT01116076 .

###25558983
OBJECTIVE	To compare the efficacy of fentanyl administered via the subcutaneous ( s.c. ) or intranasal ( i.n. ) route with intramuscular ( i.m. ) pethidine in labouring women requesting analgesia .
METHODS	A randomised controlled trial three-armed , parallel-design .
METHODS	A regional hospital and the largest tertiary maternity centre in South Australia .
METHODS	One hundred and fifty-six healthy parturients birthing at term .
METHODS	Women were randomised to receive s.c. fentanyl ( n = 53 ) , i.n. fentanyl ( n = 52 ) , or i.m. pethidine ( n = 51 ) .
METHODS	The outcomes were analysed by intention-to-treat .
METHODS	Pain scores measured before and 30 minutes after opioid administration .
RESULTS	All groups reported clinically significant reductions in pain scores ( mean range 1.2-1 .6 ; P < 0.001 ) , with no significant differences between groups .
RESULTS	Significantly more women in the fentanyl groups reported satisfaction with using the study drug again , compared with women receiving i.m. pethidine ( 82.9 % i.n. fentanyl , 80.6 % s.c. fentanyl , and 44.0 % i.m. pethidine ; P < 0.01 ) .
RESULTS	Women in the fentanyl groups experienced less sedation ( i.n. fentanyl 7.3 % , s.c. fentanyl 2.9 % , i.m. pethidine 44 % ; P 0.03 ) , shorter labours by at least 2 hours ( P < 0.05 ) , and fewer difficulties establishing breastfeeding ( 78.8 % i.m. pethidine , 39.4 % i.n. fentanyl , and 44.0 % s.c. fentanyl ; P < 0.01 ) .
RESULTS	Neonates in the pethidine group were more likely to require nursery admission ( P < 0.02 ) .
CONCLUSIONS	Fentanyl administered by s.c. and i.n. routes is as efficacious in relieving labour pain as i.m. pethidine , but resulted in greater satisfaction , less sedation , shorter labour , fewer nursery admissions , and fewer difficulties in establishing breastfeeding .
CONCLUSIONS	Fentanyl appears to be a suitable alternative to pethidine when providing parenteral pain relief to labouring women .

###25581661
BACKGROUND	Prior studies adjusting self-reported measures of alcohol intake for drink size and ethanol ( EtOH ) content have relied on single-point assessments .
METHODS	A prospective 28-day diary study investigated magnitudes of drink-EtOH adjustments and factors associated with these adjustments .
METHODS	Transdermal alcohol sensor ( TAS ) readings and prediction of alcohol-related problems by number of drinks versus EtOH-adjusted intake were used to validate drink-EtOH adjustments .
METHODS	Self-completed event diaries listed up to 4 beverage types and 4 drinking events/d .
METHODS	Eligible volunteers had weekly drinking and 3 + drinks per occasion with 26 reported days and pre - and postsummary measures ( n = 220 ) .
METHODS	Event reports included drink types , sizes , brands or spirits contents , venues , drinks consumed , and drinking duration .
RESULTS	Wine drinks averaged 1.19 , beer 1.09 , and spirits 1.54 U.S. standard drinks ( 14g EtOH ) .
RESULTS	Mean-adjusted alcohol intake was 22 % larger using drink size and strength ( brand/EtOH concentration ) data .
RESULTS	Adjusted drink levels were larger than `` raw '' drinks in all quantity ranges .
RESULTS	Individual-level drink-EtOH adjustment ratios ( EtOH adjusted/unadjusted amounts ) averaged across all days drinking ranged from 0.73 to 3.33 ( mean 1.22 ) .
RESULTS	Adjustment ratio was only marginally ( and not significantly ) positively related to usual quantity , frequency , and heavy drinking ( all ps < 0.10 ) , independent of gender , age , employment , and education , but those with lower incomes ( both p < 0.01 ) drank stronger/bigger drinks .
RESULTS	Controlling for raw number of drinks and other covariates , degree of adjustment independently predicted alcohol dependence symptoms ( p < 0.01 ) and number of consequences ( p < 0.05 ) .
RESULTS	In 30 respondents with sufficiently high-quality TAS readings , higher correlations ( p = 0.04 ) were found between the adjusted versus the raw drinks/event and TAS areas under the curve .
CONCLUSIONS	Absent drink size and strength data , intake assessments are downward biased by at least 20 % .
CONCLUSIONS	Between-subject variation in typical drink content and pour sizes should be addressed in treatment and epidemiological research .

###25441397
OBJECTIVE	T-cell activation independently predicts mortality , poor immune recovery and non-AIDS illnesses during combination antiretroviral therapy ( cART ) .
OBJECTIVE	Atorvastatin showed anti-immune activation effects among HIV-infected cART-nave individuals .
OBJECTIVE	We investigated whether adjunct atorvastatin therapy reduces T-cell activation among cART-treated adults with suboptimal immune recovery .
METHODS	A randomised double-blind placebo-controlled crossover trial , of atorvastatin 80 mg daily vs. placebo for 12 weeks , was conducted among individuals with CD4 increase < 295 cells/l after seven years of suppressive cART .
METHODS	Change in T-cell activation ( CD3 + CD4 + / CD8 + CD38 + HLADR + ) and in T-cell exhaustion ( CD3 + CD4 + / CD8 + PD1 + ) was measured using flow cytometry .
RESULTS	Thirty patients were randomised , 15 to each arm .
RESULTS	Atorvastatin resulted in a 28 % greater reduction in CD4 T-cell activation ( 60 % reduction ) than placebo ( 32 % reduction ) ; P = 0.001 .
RESULTS	Atorvastatin also resulted in a 35 % greater reduction in CD8-T-cell activation than placebo ( 49 % vs. 14 % , P = 0.0009 ) , CD4 T-cell exhaustion ( 27 % vs. 17 % in placebo ) , P = 0.001 and CD8 T-cell exhaustion ( 27 % vs. 16 % ) , P = 0.004 .
RESULTS	There was no carry-over/period effect .
RESULTS	Expected adverse events were comparable in both groups , and no serious adverse events were reported .
CONCLUSIONS	Atorvastatin reduced T-cell immune activation and exhaustion among cART-treated adults in a Ugandan cohort .
CONCLUSIONS	Atorvastatin adjunct therapy should be explored as a strategy to improve HIV treatment outcomes among people living with HIV in sub-Saharan Africa .

###24885889
BACKGROUND	Among the multiple conservative modalities , physiotherapy is a commonly utilized treatment modality in managing chronic non-specific spinal pain .
BACKGROUND	Despite the scientific progresses with regard to pain and motor control neuroscience , treatment of chronic spinal pain ( CSP ) often tends to stick to a peripheral biomechanical model , without targeting brain mechanisms .
BACKGROUND	With a view to enhance clinical efficacy of existing physiotherapeutic treatments for CSP , the development of clinical strategies targeted at ` training the brain ' is to be pursued .
BACKGROUND	Promising proof-of-principle results have been reported for the effectiveness of a modern neuroscience approach to CSP when compared to usual care , but confirmation is required in a larger , multi-center trial with appropriate evidence-based control intervention and long-term follow-up .
BACKGROUND	The aim of this study is to assess the effectiveness of a modern neuroscience approach , compared to usual care evidence-based physiotherapy , for reducing pain and improving functioning in patients with CSP .
BACKGROUND	A secondary objective entails examining the effectiveness of the modern neuroscience approach versus usual care physiotherapy for normalizing brain gray matter in patients with CSP .
METHODS	The study is a multi-center , triple-blind , two-arm ( 1:1 ) randomized clinical trial with 1-year follow-up .
METHODS	120 CSP patients will be randomly allocated to either the experimental ( receiving pain neuroscience education followed by cognition-targeted motor control training ) or the control group ( receiving usual care physiotherapy ) , each comprising of 3 months treatment .
METHODS	The main outcome measures are pain ( including symptoms and indices of central sensitization ) and self-reported disability .
METHODS	Secondary outcome measures include brain gray matter structure , motor control , muscle properties , and psychosocial correlates .
METHODS	Clinical assessment and brain imaging will be performed at baseline , post-treatment and at 1-year follow-up .
METHODS	Web-based questionnaires will be completed at baseline , after the first 3 treatment sessions , post-treatment , and at 6 and 12-months follow-up .
CONCLUSIONS	Findings may provide empirical evidence on : ( 1 ) the effectiveness of a modern neuroscience approach to CSP for reducing pain and improving functioning , ( 2 ) the effectiveness of a modern neuroscience approach for normalizing brain gray matter in CSP patients , and ( 3 ) factors associated with therapy success .
CONCLUSIONS	Hence , this trial might contribute towards refining guidelines for good clinical practice and might be used as a basis for health authorities ' recommendations .
BACKGROUND	ClinicalTrials.gov Identifier : NCT02098005 .

###25498738
BACKGROUND	Stroke is a major cause of long-term adult disability with many survivors living in the community relying on family members for on-going support .
BACKGROUND	However , reports of inadequate understanding of rehabilitation techniques are common .
BACKGROUND	A self-management DVD-based observational learning tool may help improve functional outcomes for survivors of stroke and reduce caregivers ' burden .
OBJECTIVE	This article describes the methodology of the stroke self-management rehabilitation trial .
OBJECTIVE	The overall aim of this pilot trial is to assess the feasibility and preliminary efficacy of a DVD-based intervention for improving functional outcomes of survivors of stroke 2 months postrandomization to inform the design of a full-scale randomized clinical trial .
METHODS	Recruitment of a minimum of 20 survivors of stroke and their informal caregivers ( where available ) in each of the participating centers will occur across multiple international sites .
METHODS	After baseline assessments , participants will be randomly assigned to an intervention or standard care group .
METHODS	The intervention comprises a structured DVD observation and practice schedule over 8 weeks .
METHODS	All participants will complete follow-up assessments .
RESULTS	The outcome measures will include a global shift in the Rankin Scale scores and dichotomized scores , changes in quality of life , general health , depression , and caregiver burden at 2 months postrandomization .
RESULTS	A qualitative analysis of the effects of the intervention will also be undertaken .
CONCLUSIONS	The results of the pilot study will provide knowledge of whether observational learning techniques delivered via DVD can effectively improve recovery after stroke and reduce caregiver burden .

###24398222
BACKGROUND	Ankle sprain is the most common sports-related injury with a high rate of recurrence and associated costs .
BACKGROUND	Recent studies have emphasised the effectiveness of both neuromuscular training and bracing for the secondary prevention of ankle sprains .
OBJECTIVE	To evaluate the effectiveness of combined bracing and neuromuscular training , or bracing alone , against the use of neuromuscular training on recurrences of ankle sprain after usual care .
METHODS	384 athletes , aged 18-70 , who had sustained a lateral ankle sprain , were included ( training group n = 120 ; brace group n = 126 ; combi group n = 138 ) .
METHODS	The training group received an 8-week home-based neuromuscular training programme , the brace group received a semirigid ankle brace to be worn during all sports activities for 12months , and the combi group received both the training programme , as well as the ankle brace , to be worn during all sports activities for 8 weeks .
METHODS	The main outcome measure was self-reported recurrence of the ankle sprain .
RESULTS	During the 1-year follow-up , 69 participants ( 20 % ) reported a recurrent ankle sprain : 29 ( 27 % ) in the training group , 17 ( 15 % ) in the brace group and 23 ( 19 % ) in the combi group .
RESULTS	The relative risk for a recurrent ankle sprain in the brace group versus the training group was 0.53 ( 95 % CI 0.29 to 0.97 ) .
RESULTS	No significant differences were found for time losses or costs due to ankle sprains between the intervention groups .
CONCLUSIONS	Bracing was superior to neuromuscular training in reducing the incidence but not the severity of self-reported recurrent ankle sprains after usual care .

###24690533
BACKGROUND	Recruiting cancer patients is a barrier often encountered in research trials .
BACKGROUND	However , very few randomized trials explore strategies to improve participation rates .
BACKGROUND	The purpose of this study was to evaluate the effectiveness of a pre-recruitment primer letter to recruit persons diagnosed with colorectal cancer for a research trial .
METHODS	Potentially eligible participants were identified by the Victorian Cancer Registry .
METHODS	A total of 1,062 participants were randomized to receive either a mailed explanatory primer letter designed to encourage research participation , or no primer letter .
METHODS	Two weeks after the intervention , the Victorian Cancer Registry sought permission from patients to release their contact details to researchers .
METHODS	Those who agreed were contacted and invited to the study .
RESULTS	Pre-recruitment encouragement was not effective at increasing recruitment , with no significant differences demonstrated between experimental groups .
RESULTS	Overall , 40 % ( n = 425 ) consented to participate , 25 % ( n = 243 ) refused and 35 % ( n = 394 ) did not respond .
CONCLUSIONS	While this study demonstrated disappointing outcomes , pre-recruitment letters should not be ruled out as an approach altogether .
CONCLUSIONS	Rather , future research should explore whether other factors to increase motivation , such as intensity and timing , are feasible and acceptable for contacting cancer patients .
BACKGROUND	Australian and New Zealand Clinical Trials Registry , ACTRN12609000628246 .

###25823765
OBJECTIVE	Endoscopic retrograde cholangiopancreatography ( ERCP ) is associated with radiation exposure to the endoscopist and staff that may be significant in high-volume centers .
OBJECTIVE	We investigated whether a radiation-attenuating drape over the fluoroscopy image intensifier reduces radiation exposure during ERCP .
METHODS	We performed a prospective , randomized , double-blind trial of 100 therapeutic ERCPs at a tertiary-care university center .
METHODS	Procedures were randomly assigned to groups receiving lead-free radiation-attenuating drapes ( n = 50 ) or identical sham drapes ( n = 50 ) .
METHODS	The drapes were suspended around the fluoroscopy image intensifier during ERCP .
METHODS	The primary end point was the effective dose of radiation measured at the endoscopist 's eye and neck , and at the assisting nurse 's neck .
METHODS	The cumulative annual radiation exposure was also estimated .
RESULTS	Fluoroscopy time , absorbed radiation dose , and dose area product were similar in the study groups .
RESULTS	Mean effective dose for sham vs. radiation-attenuating drape was 0.210.27 vs. 0.020.02 mSv at the endoscopist 's eye , 0.350.44 vs. 0.030.03 mSv at the endoscopist 's neck , and 0.270.34 vs. 0.020.02 mSv at the nurse 's neck ( P < 0.0001 for all comparisons ) .
RESULTS	The relative risk reduction in radiation was 90 % , 91 % , and 93 % at the three sites .
RESULTS	At a high-volume center in which an endoscopist performs 500 therapeutic ERCPs per year , the estimated cumulative annual effective dose at the endoscopist 's eye level is 126mSv with conventional protection and 12mSv with a radiation-attenuating drape , with the recommended limit being 20mSv .
CONCLUSIONS	The addition of a radiation-attenuating drape around the image intensifier during ERCP significantly decreases radiation exposure to endoscopists and staff by 90 % .

###24550171
OBJECTIVE	The ALIGN study ( NCT01061723 ) evaluated the efficacy and safety of sarilumab , the first fully human monoclonal antibody against interleukin-6 receptor - ( IL-6R ) , in patients with ankylosing spondylitis ( AS ) .
METHODS	Patients with active AS despite conventional treatment were randomised to placebo , or one of five subcutaneous dose regimens of sarilumab ( 100 , 150 or 200mg every other week , or 100 or 150mg every week ) , for 12weeks .
METHODS	The primary efficacy end point was the percentage of patients achieving the Axial SpondyloArthritis international Society ( ASAS ) 20 response criteria at week 12 .
METHODS	Secondary endpoints included ASAS40 response , ASAS partial remission , AS Disease Activity Score , high-sensitivity C-reactive protein ( hs-CRP ) value , and safety .
RESULTS	Baseline demographic and disease characteristics of the 301 patients enrolled were similar across treatment groups .
RESULTS	At week 12 , there was no statistically significant difference in ASAS20 response rate between placebo ( ASAS20 = 24.0 % ) and any sarilumab dose group .
RESULTS	A significantly greater reduction in hs-CRP value was achieved with the higher sarilumab doses versus placebo .
RESULTS	No other statistically significant differences were evident for secondary efficacy endpoints .
RESULTS	The most common treatment-emergent adverse events reported for sarilumab included infections ( non-serious ) , neutropenia , and increase in alanine aminotransferase .
RESULTS	No cases of tuberculosis , opportunistic , or fungal infections , or bowel perforations were reported .
RESULTS	Seven patients experienced a treatment-emergent serious adverse event ( all in sarilumab treatment groups ) .
RESULTS	No deaths occurred .
CONCLUSIONS	The ALIGN study shows that IL-6R blockade with sarilumab was not an effective treatment for AS .
CONCLUSIONS	Sarilumab was generally well tolerated with a manageable safety profile .

###24949728
BACKGROUND	A new formulation of tacrolimus that is characterized by prolonged release has been developed to facilitate treatment and patient compliance .
BACKGROUND	Initial therapy with prolonged release formula in heart transplantation is not widely accepted .
METHODS	We enrolled 19 patients into a randomized analysis divided into 2 groups with different initial regimens .
METHODS	There were 8 patients with a mean age of 44 13 years treated by Advagraf , and 11 patients with a mean age of 41 9 years treated by Prograf .
METHODS	Serum concentration of immunosuppressive drug was followed by its oral dosage and endomyocardial biopsy results .
METHODS	Arterial hypertension , kidney function , and incidence of diabetes mellitus were recorded .
RESULTS	There were no perioperative deaths .
RESULTS	The risk of acute rejection within 6 months following surgery was 1 ( 2 % ) in the Advagraf group and 1 ( 1.5 % ) in the Prograf group .
RESULTS	Although the serum tacrolimus results were comparable between groups , the drug 's daily dosages were different after 6 months of therapy ( 3 1 mg in the Advagraf group and 6 2 mg in the Prograf group ( p < 0.05 ) .
RESULTS	The low rate of adverse effects throughout the study was noted .
CONCLUSIONS	Prolonged-release tacrolimus formula is an efficient immunosuppressant in heart transplantation .
CONCLUSIONS	Its initial application after surgery has low risk of adverse effects with similar results to conventional formula .

###24365194
BACKGROUND	This small study has determined the effect of vitamin C on myocardial reperfusion in patients undergoing elective percutaneous coronary intervention ( PCI ) .
BACKGROUND	This study was to explore whether antioxidant vitamin C infusion before the procedure is able to affect the incidence of periprocedural myocardial injury ( PMI ) in patients undergoing PCI .
METHODS	In this prospective single-centre randomized study , 532 patients were randomized into 2 groups : the vitamin C group , which received a 3-g vitamin C infusion within 6 hours before PCI , and a control group , which received normal saline .
METHODS	The primary end point was the troponin I-defined PMI , and the second end point was the creatine kinase ( CK ) - MB-defined PMI .
METHODS	Separate analyses using both end points were performed .
METHODS	PMI was defined as an elevation of cardiac biomarker values ( CK-MB or troponin I ) > 5 times the upper limit of normal ( ULN ) , alone or associated with chest pain or ST-segment or T-wave changes .
RESULTS	After PCI , the incidence of PMI was reduced , whether defined by troponin or by CK-MB , compared with the control group ( troponin I , 10.9 % vs 18.4 % ; P = 0.016 ; CK-MB , 4.2 % vs 8.6 % ; P = 0.035 ) .
RESULTS	Logistic multivariate analysis showed that preprocedure use of vitamin C is an independent predictor of PMI either defined by troponin I ( odds ratio [ OR ] , 0.56 ; 95 % confidence interval [ CI ] , 0.33-0 .97 ; P = 0.037 ) or by CK-MB ( OR , 0.37 ; 95 % CI , 0.14-0 .99 ; P = 0.048 ) .
CONCLUSIONS	In patients undergoing elective PCI , preprocedure intravenous treatment with vitamin C is associated with less myocardial injury .

###25711324
OBJECTIVE	HIV infection has been associated with an increased risk of chronic kidney disease ( CKD ) .
OBJECTIVE	Little is known about the prevalence of CKD in individuals with high CD4 cell counts prior to initiation of antiretroviral therapy ( ART ) .
OBJECTIVE	We sought to address this knowledge gap .
METHODS	We describe the prevalence of CKD among 4637 ART-nave adults ( mean age 36.8 years ) with CD4 cell counts > 500 cells/L at enrolment in the Strategic Timing of AntiRetroviral Treatment ( START ) study .
METHODS	CKD was defined by estimated glomerular filtration rate ( eGFR ) < 60mL/min/1 .73 m ( 2 ) and/or dipstick urine protein 1 + .
METHODS	Logistic regression was used to identify baseline characteristics associated with CKD .
RESULTS	Among 286 [ 6.2 % ; 95 % confidence interval ( CI ) 5.5 % , 6.9 % ] participants with CKD , the majority had isolated proteinuria .
RESULTS	A total of 268 participants had urine protein 1 + , including 41 with urine protein 2 + .
RESULTS	Only 22 participants ( 0.5 % ) had an estimated glomerular filtration rate < 60mL/min/1 .73 m ( 2 ) , including four who also had proteinuria .
RESULTS	Baseline characteristics independently associated with CKD included diabetes [ adjusted odds ratio ( aOR ) 1.73 ; 95 % CI 1.05 , 2.85 ] , hypertension ( aOR 1.82 ; 95 % CI 1.38 , 2.38 ) , and race/ethnicity ( aOR 0.59 ; 95 % CI 0.37 , 0.93 for Hispanic vs. white ) .
CONCLUSIONS	We observed a low prevalence of CKD associated with traditional CKD risk factors among ART-nave clinical trial participants with CD4 cell counts > 500 cells/L .

###24399428
OBJECTIVE	Most patients remain symptomatic after an initial intervention with approved treatments for generalized social anxiety disorder .
OBJECTIVE	This randomized controlled trial provides systematic , prospectively derived data on the relative benefits of `` next-step '' pharmacotherapies to improve outcomes for individuals with generalized social anxiety disorder who remain symptomatic after initial treatment .
METHODS	This three site , 12-week , double-blind randomized controlled trial compared the relative benefits of three strategies for patients remaining symptomatic ( Liebowitz Social Anxiety Scale [ LSAS ] score > 50 ) after a 10-week trial of sertraline alone : the addition of up to 3.0 mg/day of clonazepam ( sertraline plus clonazepam ) , a switch to up to 225 mg/day of venlafaxine , or prolonged sertraline treatment with placebo ( sertraline plus placebo ) .
RESULTS	A total of 397 participants received at least one dose of sertraline ; 181 nonresponders ( LSAS score > 50 ) at week 10 were randomly assigned to sertraline plus clonazepam , switch to venlafaxine , or sertraline plus placebo .
RESULTS	Overall , 21 % of patients achieved remission ( LSAS score 30 ) at the endpoint , and 27 % of patients assigned to sertraline plus clonazepam achieved remission compared with patients assigned to sertraline plus placebo ( 17 % ) or venlafaxine ( 19 % ) , but the differences did not reach significance .
RESULTS	Sertraline plus clonazepam was associated with a significantly greater drop in LSAS severity ( p = 0.020 ) and disability ( p = 0.0028 ) compared with sertraline plus placebo ; no significant differences were observed on these parameters between venlafaxine and either sertraline plus placebo or sertraline plus clonazepam .
RESULTS	In supplemental analysis , the overall response rate ( LSAS score 50 ) was 46 % , including a significantly greater proportion of patients in the sertraline plus clonazepam group ( 56 % ) compared with the sertraline plus placebo group responding ( 36 % ; p = 0.027 ) ; differences did not reach significance between venlafaxine and sertraline plus placebo or sertraline plus clonazepam .
CONCLUSIONS	The findings suggest that the clonazepam augmentation strategy provides relative benefits for sertraline nonresponders in social anxiety disorder .

###24579355
OBJECTIVE	To observe the effects of transcutaneous acupoint electrical stimulation ( TAES ) combined with general anesthesia ( acupuncture analgesia combined with general anesthesia ) on postoperative pain , nausea and vomiting and exhausted defecation symptoms in patients undergoing gynecological laparoscopic operation .
METHODS	Sixty patients with gynecological laparoscopic operation were randomly divided into TAES group and control group , with 30 cases in each group .
METHODS	Patients of the control group received simple general anesthesia and those of the TAES group were treated with general anesthesia and TAES of bilateral Zusanli ( ST 36 ) and Liangqiu ( ST 34 ) .
METHODS	Visual Analogue Scale ( VAS ) was used for measuring the patients ' pain reaction at 8 h , 24 h and 72 h after surgery .
METHODS	Symptoms of patients ' nausea and vomiting , post-operation exhaust and defecation time were recorded after operation .
RESULTS	The VAS scores at time-points of 8 h , 24 h and 72 h and nausea level in the TAES group were significantly lower than those of the control group ( P < 0.01 , P < 0.05 ) .
RESULTS	The vomiting severity of the TAES group was also relatively lower in comparison with the control group , but without significant difference between the two groups ( P > 0.05 ) .
RESULTS	The post-operation exhaust and defecation time of patients in the TAES group apparently appeared earlier than those of patients in the control group ( P < 0.01 ) .
CONCLUSIONS	TAES combined with general anesthesia is effective in reducing post-operative pain and nausea , and improving gastrointestinal function in patients undergoing laparoscopic operation .

###24267730
BACKGROUND	Postmenopausal women with hormone receptor-positive ( HR ( + ) ) breast cancer in whom disease progresses or there is recurrence while taking a nonsteroidal aromatase inhibitor ( NSAI ) are usually treated with exemestane ( EXE ) , but no single standard of care exists in this setting .
BACKGROUND	The BOLERO-2 trial demonstrated that adding everolimus ( EVE ) to EXE improved progression-free survival ( PFS ) while maintaining quality of life when compared with EXE alone .
BACKGROUND	Because many women with HR ( + ) advanced breast cancer are elderly , the tolerability profile of EVE plus EXE in this population is of interest .
METHODS	BOLERO-2 , a phase III randomized trial , compared EVE ( 10mg/d ) and placebo ( PBO ) , both plus EXE ( 25 mg/d ) , in 724 postmenopausal women with HR ( + ) advanced breast cancer recurring/progressing after treatment with NSAIs .
METHODS	Safety and efficacy data in elderly patients are reported at 18-month median follow-up .
RESULTS	Baseline disease characteristics and treatment histories among the elderly subsets ( 65 years , n = 275 ; 70 years , n = 164 ) were generally comparable with younger patients .
RESULTS	The addition of EVE to EXE improved PFS regardless of age ( hazard ratio , 0.59 [ 65 years ] and 0.45 [ 70 years ] ) .
RESULTS	Adverse events ( AEs ) of special interest ( all grades ) that occurred more frequently with EVE than with PBO included stomatitis , infections , rash , pneumonitis , and hyperglycemia .
RESULTS	Elderly EVE-treated patients had similar incidences of these AEs as did younger patients but had more on-treatment deaths .
CONCLUSIONS	Adding EVE to EXE offers substantially improved PFS over EXE and was generally well tolerated in elderly patients with HR ( + ) advanced breast cancer .
CONCLUSIONS	Careful monitoring and appropriate dose reductions or interruptions for AE management are recommended during treatment with EVE in this patient population .

###24490648
OBJECTIVE	The current study tested whether self-affirmation in the context of a threatening health message helps promote a health behavior ( fruit and vegetable consumption ) over a 3-month period , and whether adding a manipulation to support the translation of intentions into behavior ( an implementation intentions induction ) enhances the impact of self-affirmation .
METHODS	Participants ( N = 332 , 71 % women ) reported their baseline consumption and were randomly assigned to condition in a 2 ( self-affirmation : yes , no ) 2 ( implementation intentions : formed , not formed ) between-subjects factorial design .
METHODS	They completed a self-affirmation/control task and then read a health communication advising eating at least 5 portions of fruit and vegetables daily .
METHODS	Next participants reported intentions for behavior change , after which they formed/did not form relevant implementation intentions .
METHODS	Consumption was measured again 7 days and 3 months postintervention .
RESULTS	Self-affirmed ( vs. nonaffirmed ) participants reported eating more fruit and vegetables at both follow-ups .
RESULTS	Forming ( vs. not forming ) implementation intentions was also beneficial for consumption .
RESULTS	At 7 days , there was also a significant self-affirmation implementation intentions interaction : consumption was highest when self-affirmed participants also formed implementation intentions .
CONCLUSIONS	The present study offers new evidence concerning the impact and durability of self-affirmation on health behaviors and the role of implementation intentions in enhancing the impact of self-affirmation .

###24776785
BACKGROUND	Classical conditioning of the eyeblink reflex is a simple form of motor learning which depends on the integrity of the cerebellum .
BACKGROUND	Acquisition of conditioned eyeblink responses is markedly reduced in patients with cerebellar disorders .
BACKGROUND	Noninvasive transcranial direct current stimulation ( tDCS ) has been reported to modify the excitability of the cerebellar cortex .
OBJECTIVE	The aim of the study was to assess whether acquisition of conditioned eyeblink responses ( CR ) is altered by cerebellar tDCS .
METHODS	A standard delay conditioning paradigm with a 540 ms tone as conditioned stimulus ( CS ) coterminating with a 100 ms air puff as unconditioned stimulus ( US ) was used in a total of 30 healthy subjects ( 18 female , 12 male , mean age 23.4 1.9 years ) .
METHODS	One hundred paired CS-US trials and 30 extinction CS alone trials were given .
METHODS	tDCS ( 2 mA intensity , ramp like onset ) was applied over the right cerebellar hemisphere ipsilaterally to the US during the acquisition phase .
METHODS	Subjects were randomly assigned to three groups ( n = 10 ) using anodal , cathodal or sham stimulation .
METHODS	The investigator as well as the participants was blinded to the stimulation modality .
RESULTS	CR acquisition was significantly enhanced by anodal tDCS ( mean total CR incidence 73.4 25.2 % ) and significantly reduced by cathodal stimulation ( 12.6 17.2 % ) compared to sham stimulation ( 43.8 24.1 % ) .
RESULTS	During anodal tDCS CR onset occurred significantly earlier , that is mean onset of responses was shifted closer to CS onset .
CONCLUSIONS	Acquisition and timing of conditioned eyeblink responses is modified by cerebellar tDCS in a polarity dependent manner .

###25453516
OBJECTIVE	This study aimed to test the effects of boiled Anethum Graveolens seeds on pain intensity and duration of labor stages .
METHODS	A randomized clinical trial was conducted on 153 eligible participants who had regular uterine contractions .
METHODS	Participants were allocated to either intervention or control group receiving boiled Anethum Graveolens seeds or routine care , respectively .
METHODS	Preparation of Anethum Graveolens boiled solution was as follows : 10g ( two tablespoons ) of seed in 100cc water boiled for 10min .
METHODS	After filtration , this solution used by intervention group only once after starting active phase ( 3-4cm of cervix dilatation ) .
METHODS	Participants were followed up to the delivery time .
METHODS	Data were analyzed using T , and Chi square tests .
RESULTS	Findings showed that the length of the all stages of labor were significantly lower in intervention compared to control group in except for second stage in primiparous .
RESULTS	The second stage of labor in primiparous participants in intervention group was shorter than control group , although the difference is not significant .
RESULTS	Moreover , intervention group had a significantly better dilatation and effacement scores after 1 , 2 , 3 and 4h following the intervention compared to control group .
CONCLUSIONS	Results supported the boiled Anethum Graveolens seeds as an effective way to progress of the labor .

###24645944
BACKGROUND	Results from an observational study involving neonates suggested that high-frequency oscillatory ventilation ( HFOV ) , as compared with conventional ventilation , was associated with superior small-airway function at follow-up .
BACKGROUND	Data from randomized trials are needed to confirm this finding .
METHODS	We studied 319 adolescents who had been born before 29 weeks of gestation and had been enrolled in a multicenter , randomized trial that compared HFOV with conventional ventilation immediately after birth .
METHODS	The trial involved 797 neonates , of whom 592 survived to hospital discharge .
METHODS	We compared follow-up data from adolescents who had been randomly assigned to HFOV with follow-up data from those who had been randomly assigned to conventional ventilation , with respect to lung function and respiratory health , health-related quality of life , and functional status , as assessed with the use of questionnaires completed when the participants were 11 to 14 years of age .
METHODS	The primary outcome was forced expiratory flow at 75 % of the expired vital capacity ( FEF75 ) .
RESULTS	The HFOV group had superior results on a test of small-airway function ( z score for FEF75 , -0.97 with HFOV vs. -1.19 with conventional therapy ; adjusted difference , 0.23 [ 95 % confidence interval , 0.02 to 0.45 ] ) .
RESULTS	There were significant differences in favor of HFOV in several other measures of respiratory function , including forced expiratory volume in 1 second , forced vital capacity , peak expiratory flow , diffusing capacity , and impulse-oscillometric findings .
RESULTS	As compared with the conventional-therapy group , the HFOV group had significantly higher ratings from teachers in three of eight school subjects assessed , but there were no other significant differences in functional outcomes .
CONCLUSIONS	In a randomized trial involving children who had been born extremely prematurely , those who had undergone HFOV , as compared with those who had received conventional ventilation , had superior lung function at 11 to 14 years of age , with no evidence of poorer functional outcomes .
CONCLUSIONS	( Funded by the National Institute for Health Research Health Technology Assessment Programme and others . )

###25496415
BACKGROUND	There is a metabolic pathway by which mammals can convert the omega-3 ( n-3 ) essential fatty acid - linolenic acid ( ALA ) into longer-chain n-3 polyunsaturated fatty acids ( LC n-3 PUFA ) including eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) .
BACKGROUND	As far as we know there are currently no studies that have specifically examined sex differences in the LC n-3 PUFA response to increased dietary ALA intake in humans , although acute studies with isotope-labelled ALA identified that women have a significantly greater capacity to synthesise EPA and DHA from ALA compared to men .
RESULTS	Available data from a placebo-controlled , randomised study were re-examined to identify whether there are sex differences in the LC n-3 PUFA response to increased dietary ALA intake in humans .
RESULTS	There was a significant difference between sexes in the response to increased dietary ALA , with women having a significantly greater increase in the EPA content of plasma phospholipids ( mean +2.0 % of total fatty acids ) after six months of an ALA-rich diet compared to men ( mean +0.7 % , P = 0.039 ) .
RESULTS	Age and BMI were identified as predictors of response to dietary ALA among women .
CONCLUSIONS	Women show a greater increase in circulating EPA than men during increased dietary ALA consumption .
CONCLUSIONS	Further understanding of individual variation in the response to dietary ALA could inform nutrition advice , with recommendations being specifically tailored according to habitual diet , sex , age and BMI .

###24919974
OBJECTIVE	Persistent use of guideline-recommended drugs after acute myocardial infarction ( AMI ) is frequently reported to be inadequate in the elderly and scarce knowledge exists about factors that influence persistence in outpatient care .
OBJECTIVE	Our aim was to evaluate drug use and its predictors in survivors of AMI above 64 years from hospital discharge to 1-year post-AMI .
METHODS	In a single-centre randomised controlled trial , discharge medication of 259 patients with AMI was obtained from medical records at hospital stay .
METHODS	Follow-up drug use and use of the healthcare system were self-reported to study nurses over 1 year in 3-month intervals .
METHODS	Predictors for persistence were modelled with multivariate logistic regression analysis considering demographics , co-morbidities and treatment characteristics .
RESULTS	At discharge , 99.2 % of the patients used anti-platelets , 86.5 % beta blockers , 95.0 % statins and 90.4 % angiotensin-converting enzyme inhibitors or angiotensin receptor blockers .
RESULTS	Use of the combination of all four drug classes decreased from discharge to 1 year post-AMI from 74.1 to 37.8 % and was significantly reduced by age 75 years ( odds ratio [ OR ] 0.49 ; 95 % confidence interval [ CI ] 0.29-0 .85 ) and ten or more visits with general practitioners ( GPs ) over 1 year ( OR 0.29 ; 95 % CI 0.17-0 .51 ) .
RESULTS	Persistence from month 3 to 12 was significantly associated with drug use at discharge for the single drug classes , but not for the drug combination .
CONCLUSIONS	Older age and frequent GP visits are associated with decreased use of the guideline-recommended drug combination after AMI .
CONCLUSIONS	Further research is needed to specify underlying reasons and develop measures to improve persistence .

###24647231
BACKGROUND	Abiraterone acetate ( an androgen biosynthesis inhibitor ) plus prednisone is approved for treating patients with metastatic castration-resistant prostate cancer ( mCRPC ) .
BACKGROUND	Study COU-AA-302 evaluated abiraterone acetate plus prednisone versus prednisone alone in mildly symptomatic or asymptomatic patients with progressive mCRPC without prior chemotherapy .
OBJECTIVE	Report the prespecified third interim analysis ( IA ) of efficacy and safety outcomes in study COU-AA-302 .
METHODS	Study COU-AA-302 , a double-blind placebo-controlled study , enrolled patients with mCRPC from April 2009 to June 2010 .
METHODS	A total of 1088 patients were stratified by Eastern Cooperative Oncology Group performance status ( 0 vs 1 ) .
METHODS	Patients were randomised 1:1 to abiraterone 1000mg plus prednisone 5mg twice daily by mouth versus prednisone .
METHODS	Co-primary end points were radiographic progression-free survival ( rPFS ) and overall survival ( OS ) .
METHODS	Median times to event outcomes were estimated using the Kaplan-Meier method .
METHODS	Hazard ratios ( HRs ) and 95 % confidence intervals ( CIs ) were derived using the Cox model , and treatment comparison used the log-rank test .
METHODS	The O'Brien-Fleming Lan-DeMets - spending function was used for OS .
METHODS	Adverse events were summarised descriptively .
CONCLUSIONS	With a median follow-up duration of 27.1 mo , improvement in rPFS was statistically significant with abiraterone treatment versus prednisone ( median : 16.5 vs 8.2 mo ; HR : 0.52 [ 95 % CI , 0.45-0 .61 ] ; p < 0.0001 ) .
CONCLUSIONS	Abiraterone improved OS ( median : 35.3 vs 30.1 mo ; HR : 0.79 [ 95 % CI , 0.66-0 .95 ] ; p = 0.0151 ) but did not reach the prespecified statistical efficacy boundary ( - level : 0.0035 ) .
CONCLUSIONS	A post hoc multivariate analysis for OS using known prognostic factors supported the primary results ( HR : 0.74 [ 95 % CI , 0.61-0 .89 ] ; p = 0.0017 ) , and all clinically relevant secondary end points and patient-reported outcomes improved .
CONCLUSIONS	While the post hoc nature of the long-term safety analysis is a limitation , the safety profile with longer treatment exposure was consistent with prior reports .
CONCLUSIONS	The updated IA of study COU-AA-302 in patients with mCRPC without prior chemotherapy confirms that abiraterone delays disease progression , pain , and functional deterioration and has clinical benefit with a favourable safety profile , including in patients treated for 24 mo. .
BACKGROUND	Study COU-AA-302 , ClinicalTrials.gov number , NCT00887198 .
RESULTS	The updated results of this ongoing study showed that disease progression was delayed in patients with advanced prostate cancer who were treated with abiraterone acetate and prednisone , and there was a continued trend in prolongation of life compared with patients treated with prednisone alone .
RESULTS	Treatment with abiraterone acetate and prednisone was well tolerated by patients who were treated for > 2 yr .

###24690084
BACKGROUND	Both Miller and Macintosh blades are widely used for laryngoscopy in small children , though the Miller blade is more commonly recommended in pediatric anesthetic literature .
BACKGROUND	The aim of this study was to compare laryngoscopic views and ease and success of intubation with Macintosh and Miller blades in small children under general anesthesia .
METHODS	One hundred and twenty children aged 1-24 months were randomized for laryngoscopy to be performed in a crossover manner with either the Miller or the Macintosh blade first , following induction of anesthesia and neuromuscular blockade .
METHODS	The tips of both the blades were placed at the vallecula .
METHODS	Intubation was performed following the second laryngoscopy .
METHODS	The glottic views with and without external laryngeal maneuver ( ELM ) and ease of intubation were observed .
RESULTS	Similar glottic views with both blades were observed in 52/120 ( 43 % ) children , a better view observed with the Miller blade in 35/120 ( 29 % ) children , and with the Macintosh blade in 33/120 ( 28 % ) .
RESULTS	Laryngoscopy was easy in 65/120 ( 54 % ) children with both the blades .
RESULTS	Restricted laryngoscopy was noted in 55 children : in 27 children with both the blades , 15 with Miller , and 13 with Macintosh blade .
RESULTS	Laryngoscopic view improved following ELM with both the blades .
CONCLUSIONS	In children aged 1-24 months , the Miller and the Macintosh blades provide similar laryngoscopic views and intubating conditions .
CONCLUSIONS	When a restricted view is obtained , a change of blade may provide a better view .
CONCLUSIONS	Placing the tip of the Miller blade in the vallecula provides satisfactory intubating conditions in this age group .

###24408514
BACKGROUND	Topical Cyperus rotundus oil is an effective and safe method to decrease hair growth .
BACKGROUND	The oil 's flavonoids have antiandrogenic activity on androgenic hair .
BACKGROUND	To date , there have been no randomized controlled trials comparing topical C rotundus oil to the available allopathic modalities , such as laser-assisted hair removal .
OBJECTIVE	In an open-label pilot study , the author prospectively evaluated the efficacy of C rotundus essential oil , compared with the Alexandrite laser ( GentleLase ; Candela Laser Corp , Wayland , Massachusetts ) and saline , for reducing unwanted axillary hair .
METHODS	Eligible participants ( n = 65 ) with unwanted axillary hair were assigned randomly to 1 of 3 study groups : topical C rotundus oil ( group 1 ) , saline ( group 2 ) , and Alexandrite laser ( group 3 ) .
METHODS	Sixty patients completed the entire study .
METHODS	Three methods were used to evaluate the results : hair counts , observations of independent professionals , and patient self-assessments .
RESULTS	Overall results did not differ significantly between C rotundus oil and the Alexandrite laser ( P > .05 ) .
RESULTS	However , statistically significant differences were noted with respect to decreased growth of white hair ( P < .05 ) , favoring the oil .
RESULTS	This finding was evident by all 3 methods of assessment .
RESULTS	No side effects were detected .
CONCLUSIONS	Cyperus rotundus essential oil is as effective as the Alexandrite laser for decreasing the growth of axillary hair ( both dark and white ) .
METHODS	3 .

###24865696
OBJECTIVE	To determine the optimal iodine mass ( IM ) to achieve a 50-HU increase in hepatic attenuation for the detection of liver metastasis based on total body weight ( TBW ) or body surface area ( BSA ) at 80-kVp computed tomography ( CT ) imaging of the liver .
METHODS	One-hundred and fifty patients who underwent contrast-enhanced CT at 80-kVp were randomised into three groups : 0.5 gI/kg , 0.4 gI/kg and 0.3 gI/kg .
METHODS	Portal venous phase images were evaluated for hepatic parenchymal enhancement ( HU ) and visualisation of liver metastasis .
METHODS	Iodine mass per BSA ( gI/m ( 2 ) ) calculated in individual patients were evaluated .
RESULTS	Mean HU for the 0.5 gI/kg group ( 84.2 HU ) was higher than in the 0.4 gI/kg ( 66.1 HU ) and 0.3 gI/kg ( 53.7 HU ) groups ( P < 0.001 ) .
RESULTS	Linear correlation equations between HU and IM per TBW or BSA are HU = 7.0 +153.0 IM/TBW ( r = 0.73 , P < 0.001 ) and HU = 11.4 +4.0 IM/BSA ( r = 0.75 , P < 0.001 ) , respectively .
RESULTS	The three groups were comparable for the visualisation of hepatic metastases .
CONCLUSIONS	The iodine mass to achieve a 50-HU increase in hepatic attenuation at 80-kVp CT was estimated to be 0.28 gI/kg of body weight or 9.6 gI/m ( 2 ) of body surface area .
CONCLUSIONS	Hepatic enhancement is expressed as HU = 7.0 +153.0 IM [ g ] / TBW [ kg ] .
CONCLUSIONS	Hepatic enhancement is expressed as HU = 11.4 +4.0 IM [ g ] / BSA [ m ( 2 ) ] .
CONCLUSIONS	Essential iodine dose at 80-kVp CT was 0.28 gI/kg or 9.6 gI/m ( 2 ) .

###24930168
OBJECTIVE	The objective of this study was to investigate if a verbal task can improve alertness and if performance changes are associated with changes in alertness as measured by EEG .
BACKGROUND	Previous research has shown that a secondary task can improve performance on a short , monotonous drive .
BACKGROUND	The current work extends this by examining longer , fatiguing drives .
BACKGROUND	The study also uses EEG to confirm that improved driving performance is concurrent with improved driver alertness .
METHODS	A 90-min , monotonous simulator drive was used to place drivers in a fatigued state .
METHODS	Four secondary tasks were used : no verbal task , continuous verbal task , late verbal task , and a passive radio task .
RESULTS	When engaged in a secondary verbal task at the end of the drive , drivers showed improved lane-keeping performance and had improvements in neurophysiological measures of alertness .
CONCLUSIONS	A strategically timed concurrent task can improve performance even for fatiguing drives .
CONCLUSIONS	Secondary-task countermeasures may prove useful for enhancing driving performance across a range of driving conditions .

###25323062
BACKGROUND	The evidence base for the efficacy of cognitive behaviour therapy ( CBT ) for treating body dysmorphic disorder ( BDD ) is weak .
OBJECTIVE	To determine whether CBT is more effective than anxiety management ( AM ) in an outpatient setting .
METHODS	This was a single-blind stratified parallel-group randomised controlled trial .
METHODS	The primary endpoint was at 12 weeks , and the Yale-Brown Obsessive Compulsive Scale for BDD ( BDD-YBOCS ) was the primary outcome measure .
METHODS	Secondary measures for BDD included the Brown Assessment of Beliefs Scale ( BABS ) , the Appearance Anxiety Inventory ( AAI ) and the Body Image Quality of Life Inventory ( BIQLI ) .
METHODS	The outcome measures were collected at baseline and week 12 .
METHODS	The CBT group , unlike the AM group , had 4 further weekly sessions that were analysed for their added value .
METHODS	Both groups then completed measures at their 1-month follow-up .
METHODS	Forty-six participants with a DSM-IV diagnosis of BDD , including those with delusional BDD , were randomly allocated to either CBT or AM .
RESULTS	At 12 weeks , CBT was found to be significantly superior to AM on the BDD-YBOCS [ = -7.19 ; SE ( ) = 2.61 ; p < 0.01 ; 95 % CI = -12.31 to -2.07 ; d = 0.99 ] as well as the secondary outcome measures of the BABS , AAI and BIQLI .
RESULTS	Further benefits occurred by week 16 within the CBT group .
RESULTS	There were no differences in outcome for those with delusional BDD or depression .
CONCLUSIONS	CBT is an effective intervention for people with BDD even with delusional beliefs or depression and is more effective than AM over 12 weeks .

###25322923
BACKGROUND	The medical food Souvenaid , containing the specific nutrient combination Fortasyn Connect , is designed to improve synapse formation and function in patients with Alzheimer 's disease ( AD ) .
BACKGROUND	Two double-blind randomized controlled trials ( RCT ) with Souvenaid of 12 and 24 week duration ( Souvenir I and Souvenir II ) showed that memory performance was improved in drug-nave mild AD patients , whereas no effects on cognition were observed in a 24-week RCT ( S-Connect ) in mild to moderate AD patients using AD medication .
BACKGROUND	Souvenaid was well-tolerated in all RCTs .
OBJECTIVE	In this 24-week open-label extension ( OLE ) study to the 24-week Souvenir II RCT , long-term safety and intake adherence of the medical food Souvenaid was evaluated .
METHODS	Patients with mild AD ( n = 201 ) received Souvenaid once-daily during the OLE .
METHODS	Main outcome parameters were safety and product intake adherence .
METHODS	The memory domain z-score from a revised neuropsychological test battery was continued as exploratory parameter .
RESULTS	Compared to the RCT , a similar ( low ) incidence and type of adverse events was observed , being mainly ( 68.3 % ) of mild intensity .
RESULTS	Pooled data ( RCT and OLE ) showed that 48-week use of Souvenaid was well tolerated with high intake adherence ( 96.1 % ) .
RESULTS	Furthermore , a significant increase in the exploratory memory outcome was observed in both the active-active and control-active groups during Souvenaid intervention .
CONCLUSIONS	Souvenaid use for up to 48-weeks was well tolerated with a favorable safety profile and high intake adherence .
CONCLUSIONS	The findings in this OLE study warrant further investigation toward the long-term safety and efficacy of Souvenaid in a well-controlled , double-blind RCT .

###24426817
BACKGROUND	Numerous studies have demonstrated that sleep promotes memory consolidation , but there is little research on the effect of hypnotics on sleep-dependent memory consolidation .
BACKGROUND	We compared bedtime administration of zolpidem-ER 12.5 mg ( 6 - to 8-h duration of action ) , middle-of-the-night administration of zaleplon 10 mg ( 3 - to 4-h duration of action ) , and placebo to examine the effect of different durations of hypnotic drug exposure on memory consolidation during sleep .
METHODS	Twenty-two participants with no sleep complaints underwent 3 conditions in a counterbalanced crossover study : ( 1 ) zolpidem-ER 12.5 mg ( bedtime dosing ) , ( 2 ) zaleplon 10 mg ( middle-of-the-night dosing ) , and ( 3 ) placebo .
METHODS	Memory testing was conducted before and after an 8-h sleep period , using a word pair association task ( WPT ; declarative memory ) and a finger-tapping task ( FTT ; procedural memory ) .
RESULTS	ANOVA revealed a significant condition effect for the WPT ( p = 0.025 ) and a trend for the FTT ( p = 0.067 ) , which was significant when sex was added to the model ( p = 0.014 ) .
RESULTS	Improvement in memory performance following sleep was lower with bedtime dosing of zolpidem-ER compared to placebo and middle-of-the-night dosing of zaleplon .
RESULTS	There were no differences between placebo and zaleplon .
CONCLUSIONS	The results suggest that in some circumstances hypnotics may have the potential to reduce the degree of sleep-dependent memory consolidation and that drug-free sleep early in the night may ameliorate this effect .

###24597906
BACKGROUND	The aim of this study was to ascertain whether individual atrioventricular delay ( AVD ) optimization using impedance cardiography ( ICG ) offers beneficial hemodynamic effects as well as improved exercise tolerance and quality of life in patients with requiring constant right ventricular pacing .
METHODS	There were 37 patients with advanced AV block included in the study .
METHODS	Several examinations were performed at the beginning .
METHODS	Next , the optimization of AVD by ICG was done .
METHODS	The next step of the study patients have been randomized into optimal AVD group ( AVDopt ) or factory setting group ( AVDfab ) .
METHODS	After 3 months , the follow-up all data were collected again and crossover was performed .
METHODS	After another 3 months , during the final follow-up all these measures were repeated .
RESULTS	In 87.5 % patients , AVDopt were different than factory value .
RESULTS	Cardiac output ( CO ) , cardiac index ( CI ) , and stroke volume ( SV ) were significantly ( P < 0.001 ) higher in AVDopt group than in AVDfab group ( CO : 6.0 1.4 L/minute vs. 5.3 1.2 L/minute ; SV : 85.8 25.7 mL vs. 76.9 22.5 mL ; CI : 3.2 0.7 L/minute/m ( 2 ) vs. 2.7 0.6 L/minute/m ( 2 ) ) .
RESULTS	There was a statistical significant ( P < 0.05 ) reduction of proBNP and NYHA class in patients with AVDopt compared to AVDfab ( proBNP : 196.4 144.7 pg/mL vs. 269.4 235.8 pg/mL ; NYHA class : 1.7 0.5 vs. 2.3 0.6 ) .
RESULTS	Six-minute walking test was significantly ( P < 0.05 ) higher in AVDopt group ( 409 90 m ) than in AVDfab group ( 362 93 m ) .
RESULTS	There were no statistically significant differences in echocardiographic parameters between AVDopt and AVDfab settings .
CONCLUSIONS	Our study results suggest that AVD optimization in patients with DDD pacemaker with ICG improves hemodynamic when compared to the default factory settings .
CONCLUSIONS	Furthermore , optimally programmed AVD reduces BNP and improves exercise tolerance and functional class .

###25059499
BACKGROUND	The prevalence of smoke-free policies in multiunit housing ( MUH ) in South Dakota was examined .
BACKGROUND	Owner beliefs about smoke-free policies were identified .
METHODS	Stratified random sampling included 27 South Dakota counties classified as frontier , large rural , or urban .
METHODS	Data collection with MUH owners in selected counties employed a telephone survey with mailed backup .
RESULTS	The owner response rate was 41.5 % ( 324/780 ) .
RESULTS	A written smoke-free policy was reported by 175 ( 54.0 % ) owners , and 31 ( 10 % ) reported a verbal smoke-free policy .
RESULTS	Owners in large rural counties ( 57.4 % ) had more written smoke-free policies than owners in urban ( 52.2 % ) and frontier ( 53.5 % ) counties .
RESULTS	Only 8.5 % of properties had policies covering both buildings and grounds .
RESULTS	Owners without policies were more than twice as likely to manage U.S. Department of Housing and Urban Development subsidized units and were three times as likely to be current smokers .
RESULTS	Owners without a smoke-free policy anticipated that a policy would decrease maintenance costs but increase turnover and vacancy rates .
RESULTS	Nearly one-half ( 47.9 % ) of owners with no smoke-free policy had previously considered implementing a policy .
RESULTS	Owners self-reported beliefs about smoke-free policies identified perceived benefits such as decreased maintenance and costs , improved tenant safety and health , and conscientious tenants .
RESULTS	Perceived drawbacks included increased outdoor maintenance , enforcement problems , concerns about long-term tenants who smoke , and freedom/rights of smokers .
CONCLUSIONS	This study provides a baseline assessment of smoke-free polices in MUH settings .
CONCLUSIONS	Perceptions of owners without smoke-free policies focused on economic concerns that were inconsistent with reports from those owners with smoke-free policies .

###24568228
BACKGROUND	As evidence-based practice ( EBP ) becomes a necessity in athletic training , Web-based modules have been developed and made available to the National Athletic Trainers ' Association membership as a mechanism to educate athletic trainers ( ATs ) on concepts of EBP .
OBJECTIVE	To assess the effect of an educational intervention on enhancing knowledge of EBP among ATs .
METHODS	Randomized controlled trial .
METHODS	Web-based modules and knowledge assessment .
METHODS	A total of 164 of 473 ATs ( 34.7 % response rate ) , including professional athletic training students , graduate students , clinical preceptors , educators , and clinicians , were randomized into a control group ( 40 men , 42 women ) or experimental group ( 33 men , 49 women ) .
METHODS	Ten Web-based modules were developed that covered concepts involved in the EBP process .
METHODS	Both groups completed the Evidence-Based Practice Knowledge Assessment before and after the intervention phase .
METHODS	During the intervention phase , the experimental group had access to the Web-based modules for 4 weeks , whereas the control group had no direct responsibilities for the investigation .
METHODS	The knowledge assessment consisted of 60 multiple choice questions pertaining to concepts presented in the 10 modules .
METHODS	Test-retest reliability was determined to be good ( intraclass correlation coefficient [ 2,1 ] = 0.726 , 95 % confidence interval = 0.605 , 0.814 ) .
METHODS	Independent variables consisted of group ( control , experimental ) and time ( preassessment , postassessment ) .
METHODS	Knowledge scores were tabulated by awarding 1 point for each correct answer ( maximum = 60 ) .
METHODS	Between-group and within-group differences were calculated using a 2 2 repeated-measures analysis of variance ( P .05 ) , post hoc t tests , and Hedges g effect size with 95 % confidence intervals .
RESULTS	We found a group time interaction ( F , = 26.29 , P < .001 ) .
RESULTS	No differences were identified between the control ( 30.12 5.73 ) and experimental ( 30.65 5.93 ) groups during the preassessment ( t = 0.58 , P = .84 ) .
RESULTS	The experimental group ( 36.35 8.58 ) obtained higher scores on the postassessment than the control group ( 30.99 6.33 ; t162 = 4.55 , P = .01 ) .
RESULTS	No differences were identified among time instances within the control group ( t = 1.77 , P = .08 ) ; however , the experimental group obtained higher scores on the postassessment than the preassessment ( t = 7.07 , P < .001 ) .
CONCLUSIONS	An educational intervention consisting of 10 Web-based modules was an effective mechanism to increase knowledge of foundational EBP concepts among ATs .
CONCLUSIONS	However , it is not known whether ATs are integrating EBP into daily clinical practice .
CONCLUSIONS	Researchers should determine whether increased knowledge of EBP affects the daily clinical decision making of ATs .

###25555877
OBJECTIVE	The aim of this studywas to observe the effects of stellate ganglion block ( SGB ) on hemodynamic changes and intrapulmonary shunt during one-lung ventilation ( OLV ) .
METHODS	Thirty ASA class I-II patients undergoing elective esophageal surgery were randomly divided into two groups : general anesthesia group ( group N , n = 15 ) and general anesthesia combined SGB group ( group S , n = 15 ) , patients in group S were received left SGB before induction .
METHODS	Radial artery was cannulated for arterial blood pressure ( ABP ) monitoring and blood sampling and Swan-Ganz catheter was position in the pulmonary artery via right internal jugular vein under local anesthesia .
METHODS	ECG , MAP , HR , CVP , continuous cardiac output ( CCO ) index and BIS were continuously monitored during anesthesia .
METHODS	General anesthesia was induced with propofol 1.5-2 .0 mg/kg , sufentanil 0.4 g/kg , and Rocuronium 0.6-0 .9 mg/kg .
METHODS	Endobronchial occluder was placed blindly after tracheal indubation and the correct position was verified by auscultation and fiberoptic bronchoscopy .
METHODS	The patients were mechanically ventilated .
METHODS	The ventilation conditions were Fio2 = 100 % , VT = 8-10 ml/kg , I : E = 1:2 and respiratory rate was adjusted to maintained PETCO2 at 35-45 mmHg during both two-lung ventilation ( TLV ) and OLV .
METHODS	Anesthesia was maintained with continuous infusion of propofol 4-10 mg/kgh , sufentanil 0.2 g/kgh , vecuronium o. 1 mg/kgh , BIS was maintained at 45-55 .
METHODS	Blood samples were taken from radial artery and S-G catheter for blood gas analysis at following intervals : during spontaneous breathing when the patient was awake ( T0 ) , 1 min after tracheal indubation ( T1 ) , 1 min after patient was placed in lateral position ( T2 ) and 15 min after it ( T3 ) , 1 min after ribs was braced ( T4 ) , 30 , 60 , 120 min during the course of OLV ( T5 , T6 , T7 ) , the two lungs were ventilated again for 30 min ( T8 ) and Qs/Qt was calculated .
RESULTS	SVRI , MAP , HR in group N increased significantly at T1 , T2 , T4 compared with group S ( p < 0.05 ) .
RESULTS	Qs/Qt was significantly increased after patient was placed in lateral position and increased further during OLV ; the calculated Qs/Qt values were highest at T5 PaO2 was significantly lower after OLV was started and reached the lowest level at T6 then was gradually increasing .
RESULTS	There was no significant difference in Qs/Qt and PaO2 at all time points between two groups .
CONCLUSIONS	SGB before induction effectively suppress the stress response work as stable blood dynamics and does not affect Qs/Qt and arterial oxygenation during OLV , SGB is a safe technique of anesthesia for general thoracic surgery .

###25728724
BACKGROUND	Acute coronary syndromes ( ACSs ) are a major cause of morbidity and mortality , yet effective ACS treatments are frequently underused in clinical practice .
BACKGROUND	Randomized trials including the CPACS-2 study suggest that quality improvement initiatives can increase the use of effective treatments , but whether such programs can impact hard clinical outcomes has never been demonstrated in a well-powered randomized controlled trial .
METHODS	The CPACS-3 study is a stepped-wedge cluster-randomized trial conducted in 104 remote level 2 hospitals without PCI facilities in China .
METHODS	All hospitalized ACS patients will be recruited consecutively over a 30-month period to an anticipated total study population of more than 25,000 patients .
METHODS	After a 6-month baseline period , hospitals will be randomized to 1 of 4 groups , and a 6-component quality improvement intervention will be implemented sequentially in each group every 6months .
METHODS	These components include the following : establishment of a quality improvement team , implementation of a clinical pathway , training of physicians and nurses , hospital performance audit and feedback , online technical support , and patient education .
METHODS	All patients will be followed up for 6months postdischarge .
METHODS	The primary outcome will be the incidence of in-hospital major adverse cardiovascular events comprising all-cause mortality , myocardial infarction or reinfarction , and nonfatal stroke .
CONCLUSIONS	The CPACS-3 study will be the first large randomized trial with sufficient power to assess the effects of a multifaceted quality of care improvement initiative on hard clinical outcomes , in patients with ACS .

###26121900
BACKGROUND	Strabismus surgery in children is often associated with undesirable intraoperative and postoperative side effects including pain , postoperative nausea and vomiting ( PONV ) , and occulocardiac reflex ( OCR ) .
BACKGROUND	Systemic analgesics have side effects and are contraindicated in some cases .
BACKGROUND	We hypothesized that the preoperative subtenon injection of bupivacaine would reduce postoperative pain and the incidence of side effects adverse effects .
METHODS	Sixty children ( 2 to 6 years of age , ASA status I to II ) were randomized to receive either subtenon bupivacaine 0.5 % or a saline injection before the beginning of surgery in a double-blind manner .
METHODS	Pain scores using the Face , Legs , Cry , Activity , and Consolability ( FLACC ) scale , incidence of OCR and PONV , requirement of additional systemic analgesia , and time to discharge from the recovery room were compared .
RESULTS	The pain scores were significantly lower in the subtenon bupivacaine group at 0 min ( p = 0.0056 ) and at 30 min ( p = 0.013 ) .
RESULTS	There was no significant difference between the two groups at the other time intervals .
RESULTS	There was a significant reduction in the incidence of occulocardiac reflex and the incidence of vomiting in the subtenon bupivacaine group .
RESULTS	Eight of the 27 patients in the subtenon bupivacaine group required additional systemic analgesia compared to 19 of 29 controls .
RESULTS	The time to discharge from recovery room was lower in the subtenon bupivacaine group .
CONCLUSIONS	These data provide some evidence that a preoperative subtenon block with bupivacaine combined with general anesthesia allows efficient control of postoperative pain as well as a reduction in the incidence of OCR and PONV in young children undergoing strabismus surgery .

###25196152
BACKGROUND	The aim of this study was to compare the diagnostic performances of multi-detector computed tomography ( MDCT ) reconstruction at two different slice thicknesses ( 1mm , ` high resolution ' vs. 5mm , ` routine ' ) with respect to the detection of blebs and bullae ( BBs ) in patients with primary spontaneous pneumothorax ( PSP ) .
METHODS	Thirty-one patients underwent wedge resection of BBs ( 29 unilateral and 2 bilateral ) for PSP from January 2010 to January 2013 .
METHODS	Two observers assessed the presence and locations of BBs independently using high-resolution CT ( HRCT ) and routine CT reconstruction , and compared the sensitivities of each reconstruction method for BB detection using operative findings as a standard reference .
METHODS	In addition , the number of BBs in each CT image set was recorded and inter-observer agreements were evaluated .
RESULTS	Sensitivity for the detection of BBs was significantly better for HRCT than routine CT ( 97.0 % vs. 63.6 % for observer 1 and 94.0 % vs. 57.6 % for observer 2 , respectively , both P-values < 0.001 ) .
RESULTS	On a per-bleb and a per-bulla basis , inter-observer agreements regarding BBs by HRCT were good and very good ( k = 0.66 and 0.94 , respectively ) and superior to those determined by routine CT ( k = 0.59 and 0.60 , respectively ) .
CONCLUSIONS	Different slice thickness reconstructions influence the diagnostic efficacy of MDCT for the detection of BBs in patients with PSP .
CONCLUSIONS	High-resolution thin slice CT reconstruction was found to have a significantly greater sensitivity than routine thicker slice thickness reconstruction for the detection of BBs .

###25113056
OBJECTIVE	The aim of this study is to conduct a preliminary examination of long-term outcomes on a broad range of affective disorder symptoms treated with a newly developed intervention : The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders ( UP ) .
METHODS	Maintenance of treatment gains at long-term follow-up ( LTFU ) were explored in patients ( N = 15 , mean age = 32.27 ; 60 % female ) who completed a clinical trial of the UP .
RESULTS	Treatment gains observed at 6-month follow-up ( 6MFU ) on measures of clinical severity , general symptoms of depression and anxiety , and a measure of symptom interference in daily functioning were largely maintained 12months later ( at an average of 18months posttreatment ) , and any significant changes from 6MFU to LTFU reflected small increases in symptoms that remained , on average , in the subclinical range .
CONCLUSIONS	These findings provide the first initial support for the durability of broad treatment gains following transdiagnostic treatment .

###24417404
BACKGROUND	High-density lipoprotein ( HDL ) particles perform numerous vascular-protective functions .
BACKGROUND	Animal studies demonstrate that exposure to fine or ultrafine particulate matter ( PM ) can promote HDL dysfunction .
BACKGROUND	However , the impact of PM on humans remains unknown .
OBJECTIVE	We aimed to determine the effect of exposure to coarse concentrated ambient particles ( CAP ) on several metrics of HDL function in healthy humans .
METHODS	Thirty-two adults ( 25.96.6 years ) were exposed to coarse CAP [ 76.251.5 gm ( -3 ) ] in a rural location and filtered air ( FA ) for 2h in a randomized double-blind crossover study .
METHODS	Venous blood collected 2 - and 20-h post-exposures was measured for HDL-mediated efflux of [ ( 3 ) H ] - cholesterol from cells and 20-h exposures for HDL anti-oxidant capacity by a fluorescent assay and paraoxonase activity .
METHODS	The changes [ median ( first , third quartiles ) ] between exposures among 29 subjects with available results were compared by matched Wilcoxon tests .
RESULTS	HDL-mediated cholesterol efflux capacity did not differ between exposures at either time point [ 16.60 % ( 15.17 , 19.19 ) 2-h post-CAP versus 17.56 % ( 13.43 , 20.98 ) post-FA , p = 0.768 and 14.90 % ( 12.47 , 19.15 ) 20-h post-CAP versus 17.75 % ( 13.22 , 23.95 ) post-FA , p = 0.216 ] .
RESULTS	HOI [ 0.26 ( 0.24 , 0.35 ) versus 0.28 ( 0.25 , 0.40 ) , p = 0.198 ] and paraoxonase activity [ 0.54 ( 0.39 , 0.82 ) versus 0.60 molmin ( -1 ) mlplasma ( -1 ) ( 0.40 , 0.85 ) , p = 0.137 ] did not differ 20-h post-CAP versus FA , respectively .
CONCLUSIONS	Brief inhalation of coarse PM from a rural location did not acutely impair several facets of HDL functionality .
CONCLUSIONS	Whether coarse PM derived from urban sites , fine particles or longer term PM exposures can promote HDL dysfunction warrant future investigations .

###25185277
OBJECTIVE	To compare the symptoms and lower airway inflammatory factors of patients with allergic rhinitis ( AR ) , and to observe the effect of nasal irrigation in the treatment of allergic rhinitis .
METHODS	Sixty-one cases diagnosed as AR after skin prick test ( SPT ) were selected and randomly divided into three groups : 17 patients in group A used nasal steroid spray ; 21 cases in group B used nasal irrigation ; 23 patients in group C combined ir rigation with nasal steroid .
METHODS	Before and after 3 months treatment , nasal visual analogue scale ( VAS ) score , rhino conjunctivtis quality of life questionnaire ( RQLQ ) score , fractional exhaled nitric oxide ( FENO ) values were observed and compared in each group .
RESULTS	Before treatment , there is no statistically difference between three groups ( P > 0.05 ) .
RESULTS	After 3 months of treatment , VAS , RQLQ , FENO of all patients was significantly decreased ( P < 0.05 ) ; VAS , RQLQ score was not significantly different among the three groups ( P > 0.05 ) , FENO value has no statistically significant difference between group A and group B ( P > 0.05 ) , but were less than that in group C ( P < 0.05 ) .
CONCLUSIONS	Nasal irrigation can ameliorate nasal symptoms , improve quality of life , decrease lower airway inflammation of allergic rhinitis patients .
CONCLUSIONS	Nasal irrigation is an effective treatment of allergic rhinitis .
CONCLUSIONS	Nasal irrigation combined with nasal steroid can achieve more significant efficacy .

###25246629
OBJECTIVE	The US public is increasingly using online rating sites to make decisions about a variety of consumer goods and services , including physicians .
OBJECTIVE	We sought to understand , within the context of other types of rating sites , parents ' awareness , perceptions , and use of physician-rating sites for choosing primary care physicians for their children .
METHODS	This cross-sectional , nationally representative survey of 3563 adults was conducted in September 2012 .
METHODS	Participants were asked about rating Web sites in the context of finding a primary care physician for their children and about their previous experiences with such sites .
RESULTS	Overall , 2137 ( 60 % ) of participants completed the survey .
RESULTS	Among these respondents , 1619 were parents who were included in the present analysis .
RESULTS	About three-quarters ( 74 % ) of parents were aware of physician-rating sites , and about one-quarter ( 28 % ) had used them to select a primary care physician for their children .
RESULTS	Based on 3 vignettes for which respondents were asked if they would follow a neighbor 's recommendation about a primary care physician and using multivariate analyses , respondents exposed to a neighbor 's recommendation and positive online physician ratings were significantly more likely to choose the recommended physician ( adjusted odds ratio : 3.0 [ 95 % confidence interval : 2.1-4 .4 ] ) than respondents exposed to the neighbor 's recommendation alone .
RESULTS	Conversely , respondents exposed to the neighbor 's recommendation and negative online ratings were significantly less likely to choose the neighbor children 's physician ( adjusted odds ratio : 0.09 [ 95 % confidence interval : 0.03-0 .3 ] ) .
CONCLUSIONS	Parents are beginning to use online physician ratings , and these ratings have the potential to influence choices of their children 's primary care physician .

###24231216
OBJECTIVE	To evaluate the efficacy and safety of duloxetine hydrochloride in the treatment of patients affected by chronic prostatitis/chronic pelvic pain syndrome ( CP/CPPS ) .
METHODS	Thirty-eight CP/CPPS patients completed the National Institutes of Health Chronic Prostatitis Symptom Index ( NIH-CPSI ) and International Index of Erectile Function-Erectile Function-5 ( IIEF-5 ) questionnaires , uroflowmetry , and evaluation of psychologic status using Hamilton Anxiety Scale ( HAM-A ) and Hamilton Depression Scale ( HAM-D ) .
METHODS	Patients were randomly assigned to 2 treatments groups .
METHODS	Treatment in group 1 consisted of a simultaneous oral administration of tamsulosin ( 0.4 mg/d , 60 mg/d ) , saw palmetto ( 320 mg/d ) , and duloxetine ( 60 mg/d ) .
METHODS	Treatment in group 2 consisted of tamsulosin ( 0.4 mg/d ) and saw palmetto ( 320 mg/d ) .
METHODS	NIH-CPSI and IIEF-5 questionnaires , uroflowmetry , and evaluation of the psychological status were repeated at 16 weeks of follow-up .
RESULTS	At 16 weeks , a significant improvement in NIH-CPSI pain subscore , NIH-CPSI quality of life subscore , and NIH-CPSI total score were observed in group 1 patients compared with those in group 2 ( P < .01 , respectively ) , together with a significant improvement in HAM-A and HAM-D scores ( P < .01 , respectively ) .
RESULTS	Patients in group 2 showed a significant improvement in NIH-CPSI total score , in the urinary symptoms subscore , and in the HAM-A total score .
RESULTS	No significant differences were observed in IIEF-5 scores in the 2 groups .
RESULTS	Maximum flow rate significantly increased in both groups .
RESULTS	In group 1 , 20 % of patients stopped the study due to adverse effects .
CONCLUSIONS	The use of duloxetine in a multimodal treatment with an - blocker medication and a saw palmetto extract allowed better results in controlling clinical symptoms , psychologic status and quality of life patients affected by CP/CPPS .

###24700145
OBJECTIVE	Artificial language learning studies have demonstrated that learners exposed to many different nonword combinations representing a grammatical form demonstrate rapid learning of that form without explicit instruction .
OBJECTIVE	However , learners presented with few exemplars , even when they are repeated frequently , fail to learn the underlying grammar .
OBJECTIVE	This study translated this experimental finding in a therapeutic context .
METHODS	Eighteen preschool children with language impairment received conversational recast treatment for morpheme errors .
METHODS	Over a 6-week period , half heard 12 unique verbs twice each during recasts ( low-variability condition ) , and half heard 24 unique verbs ( high-variability condition ) .
METHODS	Children 's use of trained and untrained morphemes on generalization probes as well as spontaneous use of trained morphemes was tracked throughout treatment .
RESULTS	The high-variability condition only produced significant change in children 's use of trained morphemes , but not untrained morphemes .
RESULTS	Data from individual children confirmed that more children in the high - than the low-variability condition showed a strong treatment effect .
RESULTS	Children in the high-variability condition also produced significantly more unique utterances containing their trained morpheme than children in the low-variability condition .
CONCLUSIONS	The results support the use of highly variable input in a therapeutic context to facilitate grammatical morpheme learning .

###25516024
OBJECTIVE	To determine factors mediating the effects of a depression intervention for older African Americans on functional disability and , secondarily , whether functional improvements mediate intervention effects on depressive symptoms .
METHODS	Structural equation modeling to examine mediators in a secondary analysis of a randomized trial with 4-month follow-up .
METHODS	Philadelphia region .
METHODS	Community-dwelling African Americans ( 55 ) with depressive symptoms living in an urban area ( N = 208 ) .
METHODS	Up to 10 one-hour sessions over 4 months conducted by licensed social workers who provided care management , referrals and linkages , stress reduction techniques , depression knowledge and symptom recognition , and behavioral activation techniques .
METHODS	Main outcome was self-reported functional difficulty level for 18 basic activities .
METHODS	Mediators included depression severity ( Patient Health Questionnaire ) , depression knowledge and symptom recognition , behavioral activation , and anxiety .
RESULTS	At 4 months , the intervention had positive effects on functional difficulty and all mediators ( P < .001 ) .
RESULTS	Separate structural equation models indicated that two factors ( reduced depressive symptoms ( 23.5 % mediated ) and improved depression knowledge and symptom recognition ( 52.9 % mediated ) ) significantly mediated the intervention 's effect on functional disability .
RESULTS	Enhancing behavioral activation and decreasing anxiety were not found to mediate improvements in functional disability .
RESULTS	The two significant mediators jointly explained 62.5 % of the intervention 's total effect on functional disability .
RESULTS	Functional improvement was not found to mediate the intervention 's effect on depressive symptoms .
CONCLUSIONS	This multicomponent depression intervention for African Americans has an effect on functional disability that is driven primarily by enhancing symptom recognition and decreasing depressive symptoms .
CONCLUSIONS	Reduction of functional difficulties did not account for improvements in depressive symptoms .
CONCLUSIONS	Nonpharmacological treatments for depressive symptoms that enhance symptom recognition in older African Americans can also reduce their functional difficulties with daily living activities .

###25150151
BACKGROUND	Studies suggest that MRI is an accurate means for assessing tumor size after neoadjuvant chemotherapy ( NAC ) .
BACKGROUND	However , accuracy might be dependent on the receptor status of tumors .
BACKGROUND	MRI accuracy for response assessment after homogenous NAC in a relative large group of patients with stage II/III HER2-negative breast cancer has not been reported before .
METHODS	250 patients from 26 hospitals received NAC ( docetaxel , adriamycin and cyclophosphamide ) in the context of the NEOZOTAC trial .
METHODS	MRI was done after 3 cycles and post-NAC .
METHODS	Imaging ( RECIST 1.1 ) and pathological ( Miller and Payne ) responses were recorded .
METHODS	Accuracy measures were calculated and MRI and pathologically assessed tumor sizes were correlated .
METHODS	Tumor size over - and underestimation were quantified .
RESULTS	Accuracy of MRI for determining pathological complete response ( pCR ) was 76 % .
RESULTS	The ROC-curve of MRI response and pCR had an area under the curve value of 0.63 ( 95 % C.I. 0.52-0 .74 ) .
RESULTS	The correlation coefficient of MRI and histopathological tumor measurements was 0.46 ( p < 0.001 ) .
RESULTS	Correlations were different for ER-positive ( r = 0.40 , p < 0.001 ) and ER-negative ( r = 0.76 , p < 0.001 ) breast tumors .
RESULTS	MRI under - and overestimated the tumor size in 47 % and 40 % of all patients .
RESULTS	In cases of substantial tumor size underestimation ( > 2 cm ) , surgical margins were more often tumor positive compared to the rest of the patients ( 33 % vs. 12 % , p = 0.005 ) .
CONCLUSIONS	MRI measurements correlated moderately with tumor size on the surgical specimen .
CONCLUSIONS	Only in ER-negative breast tumors , MRI tumor sizes correlated sufficiently with residual tumor size on the pathological specimen .
CONCLUSIONS	Therefore , post-NAC MRI should be interpreted with caution .

###25128922
OBJECTIVE	To evaluate the efficacy of alveolar corticotomy on orthodontic tooth movement when retracting upper canines compared with the conventional technique and to evaluate patients ' pain and discomfort levels after corticotomy .
METHODS	A split-mouth design randomized controlled trial at the Department of Orthodontics ( University Al-Baath Dental School ) was performed .
METHODS	A total of 30 patients whose orthodontic treatment required canine retraction were included .
METHODS	The predictor variable was the use of corticotomy to facilitate tooth movement .
METHODS	The velocity of space closure was evaluated as the primary outcome variable by measuring the distance between the canine and first molar on each side of the mouth immediately after corticotomy and at 1 , 2 , 4 , 8 , and 12 weeks after corticotomy .
METHODS	The levels of pain and discomfort were evaluated as the secondary outcome variables using a questionnaire administered 4 times during the first week after corticotomy .
METHODS	Paired t tests or Wilcoxon matched-pairs signed-rank tests were used to detect significant differences .
RESULTS	A total of 30 patients ( 15 males and 15 females ) were recruited with a mean age of 20.04 3.63 years ( range 15 to 24 ) .
RESULTS	The space closure velocity after corticotomy was significantly faster on the experimental side than on the control side ( mean = 0.74 mm/week vs 0.20 mm/week between 1 week after and immediately after corticotomy , respectively ; P < .001 ) .
RESULTS	The pain encountered during eating was high , with 50 % and 30 % of patients reporting severe pain at 1 and 3 days postoperatively , respectively .
RESULTS	No significant differences were detected between the male and female patients regarding the tooth movement velocity on the experimental side .
CONCLUSIONS	Alveolar corticotomy increased orthodontic tooth movement and was accompanied by moderate degrees of pain and discomfort .

###25442243
OBJECTIVE	The purpose of this study was to determine the effect of amoxicillin/clavulanic acid to prevent infection following completely bone-impacted lower third molar removal .
METHODS	A random , double-blind placebo-controlled clinical trial including 118 adults randomly allocated to placebo ( 60 patients ) or antibiotic treatment ( 58 patients ) : 2g amoxicillin/125mg clavulanic acid 2hours before the surgery and post-operatively twice a day for 4days .
METHODS	Infection was clinically assessed until 8weeks after surgery .
METHODS	Adverse events , as well as clinical and surgical variables , were recorded .
METHODS	Analysis was by intention to treat .
RESULTS	Infections developed in five patients in the placebo group , all in the first postoperative week , and in two in the antibiotic group , both after the first week , the difference not being statistically significant ( P = .278 , number needed to treat 19 [ 8 - ] ) .
RESULTS	There were no relationships between any variables studied and infection .
RESULTS	No serious adverse events were reported .
CONCLUSIONS	There is insufficient evidence to recommend routine use of this antibiotic treatment .

###24565455
BACKGROUND	Treatment regimens for omalizumab are guided by a dosing table that is based on total serum IgE and body weight .
BACKGROUND	Limited data exist about onset and offset of omalizumab efficacy in children and adolescents or subgroups that most benefit from treatment .
OBJECTIVE	Post hoc analyses were conducted to ( 1 ) examine patient characteristics of those eligible and ineligible for omalizumab , ( 2 ) describe onset of effect after initiation of omalizumab and offset of treatment effect after stopping therapy , and ( 3 ) determine whether the efficacy differs by age , asthma severity , dosing regimen , and prespecified biomarkers .
METHODS	Inner-city children and adolescents with persistent allergic asthma were enrolled in the Inner-City Anti-IgE Therapy for Asthma trial that compared omalizumab with placebo added to guidelines-based therapy for 60 weeks .
RESULTS	Two hundred ninety-three of 889 participants ( 33 % ) clinically suitable for omalizumab were ineligible for dosing according to a modified dosing table specifying IgE level and body weight criteria .
RESULTS	Baseline symptoms were comparable among those eligible and ineligible to receive omalizumab , but other characteristics ( rate of health care utilization and skin test results ) differed .
RESULTS	The time of onset of omalizumab effect was < 30 days and time of offset was between 30 and 120 days .
RESULTS	No difference in efficacy was noted by age or asthma severity , but high exhaled nitric oxide , blood eosinophils , and body mass index predicted efficacy .
CONCLUSIONS	A significant portion of children and adolescents particularly suited for omalizumab because of asthma severity status may be ineligible due to IgE > 1300 IU/mL .
CONCLUSIONS	Omalizumab reduced asthma symptoms and exacerbations rapidly ; features associated with efficacy can be identified to guide patient selection .

###25129681
BACKGROUND	Rhinovirus-induced wheezing is an important risk factor for recurrent wheezing .
BACKGROUND	There are no randomized controlled trials on the effect of systemic corticosteroids in patients with this disease .
OBJECTIVE	We sought to study the short - and long-term effects of prednisolone treatment of the first acute , moderate-to-severe , rhinovirus-induced wheezing episode in young children .
METHODS	After confirming rhinovirus from nasopharyngeal aspirate by using PCR , 79 children with a first wheezing episode at age 3 to 23 months were randomized to receive oral prednisolone ( first dose of 2 mg/kg , followed by 2 mg/kg/d in 2 divided doses for 3 days ) or placebo .
METHODS	The trial was double blind throughout the 12-month follow-up .
METHODS	The primary outcomes were long term : new physician-confirmed wheezing episode within 2 months , number of physician-confirmed wheezing episodes within 12 months , and initiation of regular controller medication for asthma symptoms within 12 months .
METHODS	The primary interaction analysis examined rhinovirus load .
RESULTS	Seventy-four patients completed the study ( mean age , 13 months ; 28 % atopic ) .
RESULTS	Long-term outcomes did not differ between groups ( all P .30 ) .
RESULTS	For short-term outcomes , the prednisolone group had less cough , rhinitis , noisy breathing , severe breathing difficulties , and nocturnal respiratory symptoms at home within 2 weeks ( all P < .05 ) .
RESULTS	The 25 children with greater than 7000 rhinovirus copies/mL ( most sensitive cutoff ) benefitted from prednisolone in terms of less risk of physician-confirmed recurrence within 2 and 12 months compared with placebo ( both P < .05 ) .
CONCLUSIONS	Prednisolone can not be routinely recommended for all young children experiencing their first acute , moderate-to-severe , rhinovirus-induced wheezing episode .
CONCLUSIONS	Prednisolone might be beneficial in a subgroup of children with high viral loads .

###25030489
OBJECTIVE	This study aims to investigate two different distraction methods , distraction cards and kaleidoscope , on pain and anxiety relief of children during phlebotomy .
METHODS	This study is a prospective , randomized and controlled trial .
METHODS	The sample consisted of 7-11 year-old children who required blood tests .
METHODS	Children were randomized into three groups : the distraction cards group , the kaleidoscope group , and the control group .
METHODS	Data were obtained by interviewing the children with their parents and the observer before and after the procedure .
METHODS	The pain levels of the children were assessed by the parent and observer reports as well as self report using the Wong Baker FACES Pain Rating Scale .
METHODS	The anxiety levels of children were assessed by parent and observer reports using Children Fear Scale .
RESULTS	One hundred and eighty-eight children ( mean age , 8.81.5 years ) were included .
RESULTS	The pain levels of children showed significant differences among the groups ( p = .005 ) .
RESULTS	Both the distraction card group ( 2.412.49 ) and the kaleidoscope group ( 3.102.16 ) had lower pain levels than the control group did ( 4.443.64 ) .
RESULTS	The distraction card group had the lowest pain levels ( 2.412.49 ) among all groups .
RESULTS	The procedural anxiety levels of children were significantly different among the groups ( p = < .001 ) .
RESULTS	Both the distraction card group ( 1.101.20 ) and the kaleidoscope group ( 1.611.12 ) had lower anxiety levels than the control group did ( 2.411.30 ) .
RESULTS	The distraction card group had the lowest anxiety levels ( p = < .001 ) .
CONCLUSIONS	The distraction cards were the most effective method for pain and anxiety relief of children during phlebotomy .
CONCLUSIONS	Also the distraction method with kaleidoscope was an effective method for pain and anxiety relief during phlebotomy in children .

###24885672
BACKGROUND	Chronic obstructive pulmonary disease ( COPD ) affects millions worldwide .
BACKGROUND	Although many therapies exist and are being developed to relieve symptoms and reduce mortality , few data are available to understand which of the therapeutic alternatives is the most cost-effective for COPD patients in everyday clinical practice , especially for traditional Chinese medicine ( TCM ) .
BACKGROUND	Comparative effectiveness research can help patients , clinicians , and decision-makers make best informed treatment decisions where such evidence was previously lacking .
BACKGROUND	This study aims to compare the effectiveness and economic evaluation of three treatments : ( 1 ) conventional Western medicine ; ( 2 ) TCM treatments , which have been evaluated and have certain effect ; and ( 3 ) a combination of both conventional Western medicine and TCM treatments , and then determine which treatment is the most suitable for COPD patients .
METHODS	A multicenter , pragmatic , randomized , controlled trial is adopted .
METHODS	A total of 360 patients will be recruited and randomly assigned to one of the three treatments group , with 120 in each group .
METHODS	Patients in the conventional Western medicine group will be given Salbutamol , Formoterol , Salmeterol/fluticasone , respectively , according to the guidelines .
METHODS	For the TCM group , patients will be given Bufei granule , Bu-Fei Jian-Pi granule , Bu-Fei Yi-Shen granule , and Yi-Qi Zi-Shen granule based on their corresponding TCM syndrome patterns , respectively .
METHODS	For the combination of conventional medicine and TCM treatments group , patients will be given a combination of conventional Western medicine and TCM granules .
METHODS	Treatments in each group are recognized as a whole comprehensive intervention .
METHODS	After the 26-week treatment , another 26weeks will be followed up .
METHODS	The outcome measures including the frequency and duration of acute exacerbations , lung function , dyspnea , exercise capacity , quality of life , and economic evaluation will be assessed .
CONCLUSIONS	It is hypothesized that each of the three treatments will have beneficial effects in reducing the frequency and duration of acute exacerbations , improving exercise capacity and psychosocial function of COPD patients .
CONCLUSIONS	In addition , the combination of conventional medicine and TCM treatments may be most suitable for COPD patients with better effectiveness and economic evaluation .
BACKGROUND	ClinicalTrials.gov NCT01836016 .

###25270901
BACKGROUND	The objective was to evaluate the effects of aortic annulus size on valve hemodynamics and clinical outcomes in those patients included in the Placement of Aortic Transcatheter Valves ( PARTNER ) randomized controlled trial cohort A and the nonrandomized continued access cohort .
RESULTS	Patients included the randomized controlled trial ( n = 574 ) and nonrandomized continued access ( n = 1358 ) cohorts were divided in tertiles according to aortic annulus diameter ( small aortic annulus tertile , medium aortic annulus tertile , and large aortic annulus tertile [ LAA ] , respectively ) as measured by transthoracic echocardiography .
RESULTS	Severe prosthesis-patient mismatch was defined as an effective aortic orifice area of < 0.65 cm ( 2 ) / m ( 2 ) .
RESULTS	In the randomized controlled trial cohort , patients in the small aortic annulus tertile who underwent transcatheter aortic valve replacement had a lower incidence of severe prosthesis-patient mismatch ( 19.7 % versus 37.5 % ; P = 0.03 ) and only a trend toward a higher incidence of moderate-to-severe paravalvular leaks compared with surgical aortic valve replacement ( 5.7 % versus 0 % ; P = 0.06 ) .
RESULTS	In the LAA tertile , there were no differences in the rate of prosthesis-patient mismatch between groups , and a significant increase in moderate-to-severe paravalvular leaks was associated with transcatheter aortic valve replacement ( 9 % versus 0 % ; P = 0.01 ) .
RESULTS	There were no differences in mortality between transcatheter aortic valve replacement and surgical aortic valve replacement .
RESULTS	In the nonrandomized continued access cohort , there were no differences in prosthesis-patient mismatch between the small aortic annulus and LAA tertiles , but a higher rate of moderate-to-severe paravalvular leaks was observed in the LAA tertile ( 5.9 % versus 11.5 % ; P = 0.009 ) .
RESULTS	Patients in the LAA tertile had a higher mortality rate at 1-year follow-up ( P = 0.02 ) , and differences persisted in multivariable analysis ( P = 0.048 for LAA versus medium aortic annulus tertile , P = 0.035 for LAA versus small aortic annulus tertile ) .
CONCLUSIONS	Aortic annulus size had a major impact on valve hemodynamics and clinical outcomes after transcatheter aortic valve replacement and surgical aortic valve replacement .
CONCLUSIONS	This study highlights the importance of considering aortic annulus size in the evaluation of high-risk patients who are candidates for aortic valve replacement .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00530894 .

###24674307
BACKGROUND	The survival benefits of colon cancer surveillance programs are well delineated , but less is known about the magnitude of false positive testing .
BACKGROUND	The objective of this study was to estimate the false positive rate and positive predictive value of testing as part of a surveillance program based on national guidelines , and to estimate the degree of testing and resource use needed to identify a curable recurrence .
METHODS	Analysis of clinically significant events leading to suspicion of cancer recurrence , false positive events , true cancer recurrences , time to confirmation of diagnosis , and resource use ( radiology , blood samples , colonoscopies , consultations ) among patients included in a randomised colon cancer surveillance trial .
RESULTS	110 patients surgically treated for colon cancer were followed according to national guidelines for 1884 surveillance months .
RESULTS	1105 tests ( 503 blood samples , 278 chest x-rays , 209 liver ultrasounds , 115 colonoscopies ) and 1186 health care consultations were performed .
RESULTS	Of the 48 events leading to suspicion of cancer recurrence , 34 ( 71 % ) represented false positives .
RESULTS	Thirty-one ( 65 % ) were initiated by new symptoms , and 17 ( 35 % ) were initiated by test results .
RESULTS	Fourteen patients had true cancer recurrence ; 7 resections of recurrent disease were performed , 4 of which were successful R0 metastasis Resections .
RESULTS	276 tests and 296 healthcare consultations were needed per R0 resection ; the cost per R0 surgery was 103207 .
RESULTS	There was a 29 % probability ( positive predictive value ) of recurrent cancer when a diagnostic work-up was initiated based on surveillance testing or patient complaints .
CONCLUSIONS	We observed a high false positive rate and low positive predictive value for significant clinical events suggestive of possible colorectal cancer relapse in the setting of a post-treatment surveillance program based on national guidelines .
CONCLUSIONS	Providers and their patients should have an appreciation for the modest positive predictive value inherent in colorectal cancer surveillance programs in order to make informed choices , which maximize quality of life during survivorship .
CONCLUSIONS	Better means of tailoring surveillance programs based on patient risk would likely lead to more effective and cost-effective post-treatment follow-up .
BACKGROUND	ClinicalTrials.gov identifier NCT00572143 .
BACKGROUND	Date of trial registration : 11th of December 2007 .

###24462850
OBJECTIVE	There are many instruments with different energy modalities or with different properties that are available for use in total laparoscopic hysterectomy .
OBJECTIVE	The aim of the study was to compare the use of LigaSure ( Valleylab , Boulder , CO ) , HALO PKS cutting forceps ( Gyrus-ACMI , Maple Grove , MA ) , and ENSEAL tissue sealer ( SurgRx , Inc. .
OBJECTIVE	Redwood City , CA ) in total laparoscopic hysterectomy with respect to operation time and blood loss as main outcomes .
OBJECTIVE	Perioperative complications , return of gastrointestinal activity , and hospitalization time were assessed as secondary outcomes .
METHODS	Randomized prospective study ( Canadian Task Force classification I ) .
METHODS	Adana Numune Training and Research Hospital .
METHODS	Forty-five patients with the indication of hysterectomy were randomized into 3 groups for total laparoscopic hysterectomy .
METHODS	Patients with malignancies , having 3 or more previous abdominal surgeries , a uterus larger than 12weeks of gestation , and who had to undergo additional surgical procedures during the same operation were excluded .
METHODS	Total laparoscopic hysterectomy .
RESULTS	Operations were completed in all 15 patients in the LigaSure and HALO PKS Cutting Forceps groups with the planned instruments .
RESULTS	In 2 patients in the ENSEAL group , bleeding could not be controlled with ENSEAL , and additional instruments were used .
RESULTS	One patient in the ENSEAL group had bladder injury .
RESULTS	The mean operation time and blood loss were 52.412.8 , 51.8614.11 , and 55.715.7 minutes ( p > .05 ) and 13854.3 , 11863.3 , and 218115.9 mL ( p < .05 ) in the LigaSure , HALO PKS , and ENSEAL groups , respectively .
RESULTS	Changes in hemoglobin/hematocrit levels , return of gastrointestinal activity , and hospitalization time did not differ between groups .
CONCLUSIONS	These 3 novel bipolar platforms had similar results in total laparoscopic hysterectomy .
CONCLUSIONS	These instruments were not determined to be independent predictors of operating time and amount of blood loss .

###25350539
BACKGROUND	Parents often want to provide support to their children during medical procedures , but not all parents are effective in providing distraction after brief training .
OBJECTIVE	The aim of this study was to investigate the effects of three doses of distraction intervention for children at high and medium risk for procedure-related distress .
METHODS	Children undergoing scheduled intravenous insertions for diagnostic or treatment purposes and their parents participated .
METHODS	A computerized application , Children , Parents and Distraction , was used to predict distress risk .
METHODS	Doses of intervention were basic ( parents trained on providing distraction ) , enhanced ( basic training plus tailored instructions , environmental modifications , and support and guidance from the research assistant ) , and professional ( a trained research assistant provided distraction ) .
METHODS	Outcome measures were Observational Scale of Behavioral Distress-Revised for behavioral distress , Oucher for self-reported pain , parent report of child distress , and salivary cortisol for physiological distress .
RESULTS	A total of 574 children , ages 4-10 , and their parents participated .
RESULTS	The Children , Parents and Distraction predicted that the risk for distress was high for 156 children , medium for 372 , and low for 46 .
RESULTS	Children predicted to have higher risk for distress displayed more behavioral distress ( p < .01 ) .
RESULTS	Children in the medium-risk group who had the professional intervention displayed significantly less behavioral distress ( p < .001 ) .
RESULTS	Children in the high-risk group tended to have less behavioral distress when receiving the professional intervention ( p = .07 ) .
RESULTS	There were no significant group differences for self-report of pain , parent report of distress , or cortisol levels .
CONCLUSIONS	Some parents may need additional training in providing distraction to their children during procedures , and some children at medium and high risk for distress may need professional support .
CONCLUSIONS	Parents should be asked about their preferences in acting as the distraction coach and , if willing , be provided as much training and support as possible in the clinical situation .

###24480156
OBJECTIVE	The purposes of this study were to evaluate the reproducibility for measuring the cold pressor test ( CPT ) - induced myocardial blood flow ( MBF ) alteration using phase-contrast ( PC ) cine MRI , and to determine if this approach could detect altered MBF response to CPT in smokers .
METHODS	After obtaining informed consent , ten healthy male non-smokers ( mean age : 285 years ) and ten age-matched male smokers ( smoking duration 5 years , mean age : 283 years ) were examined in this institutional review board approved study .
METHODS	Breath-hold PC cine MR images of the coronary sinus were obtained with a 3T MR imager with 32 channel coils at rest and during a CPT performed after immersing one foot in ice water .
METHODS	MBF was calculated as coronary sinus flow divided by the left ventricular ( LV ) mass which was given as a total LV myocardial volume measured on cine MRI multiplied by the specific gravity ( 1.05 g/mL ) .
RESULTS	In non-smokers , MBF was 0.860.25 mL/min/g at rest , with a significant increase to 1.200.36 mL/min/g seen during CPT ( percentage change of MBF ( MBF ( % ) ) ; 39.2 % 14.4 % , p < 0.001 ) .
RESULTS	Inter-study reproducibility for MBF ( % ) measurements by different MR technologist was good , as indicated by the intraclass correlation coefficient of 0.93 and reproducibility coefficient of 10.5 % .
RESULTS	There was no significant difference between smokers and non-smokers for resting MBF ( 0.850.32 mL/min/g , p = 0.91 ) .
RESULTS	However , MBF ( % ) in smokers was significantly reduced ( -4.032.2 % vs. 39.214.4 % , p = 0.011 ) .
CONCLUSIONS	PC cine MRI can be used to reproducibly quantify MBF response to CPT and to detect impaired flow response in smokers .
CONCLUSIONS	This MR approach may be useful for monitoring the sequential change of coronary blood flow in various potentially pathologic conditions and for investigating its relationship with cardiovascular risk .

###24286360
OBJECTIVE	We compared the efficacy of melatonin and placebo as adjuvants in the withdrawal of patients from long term temazepam , zopiclone or zolpidem ( here ` BZD ' ) use .
METHODS	A double-blind , placebo-controlled , randomized trial was conducted in a primary health care outpatient clinic .
METHODS	Ninety-two men or women ( 55 years ) with primary insomnia and chronic BZD use received controlled release melatonin 2 mg ( CRM ) ( n = 46 ) or placebo ( n = 46 ) during the 1 month withdrawal from BZDs .
METHODS	Psychosocial support was provided .
METHODS	Follow-up continued for up to 6 months .
METHODS	Successful BZD withdrawal by the end of 1 month was confirmed by BZD plasma determinations , while reduction in BZD use and abstinence continuing for 6 months were noted .
RESULTS	There were two drop-outs on CRM and one on placebo .
RESULTS	After a 1 month withdrawal , 31 participants ( 67 % ; 95 % CI 54 , 81 ) on CRM and 39 ( 85 % ; 74 , 95 ) on placebo had withdrawn completely ( intention-to-treat analysis between groups , P = 0.051 ; per protocol P = 0.043 ) .
RESULTS	Reduction in BZD use was similar or even more rare in the CRM than in the placebo group ( P = 0.052 per protocol ) .
RESULTS	After 6 months , 14 participants in the CRM group and 20 in the placebo group remained non-users of BZD ( NS between groups ) .
RESULTS	BZD doses were higher in the CRM than in the placebo group at the end of the 6 month follow-up ( P = 0.025 ) .
RESULTS	Withdrawal symptoms did not differ between the groups .
CONCLUSIONS	Gradual dose reduction of BZDs combined with CRM or placebo , and psychosocial support produced high short term and moderate long term BZD abstinence .
CONCLUSIONS	CRM showed no withdrawal benefit compared with placebo .

###24760791
BACKGROUND	Pain due to bone metastases is a common cause of cancer-related morbidity , with few options available for patients refractory to medical therapies and who do not respond to radiation therapy .
BACKGROUND	This study assessed the safety and efficacy of magnetic resonance-guided focused ultrasound surgery ( MRgFUS ) , a noninvasive method of thermal tissue ablation for palliation of pain due to bone metastases .
METHODS	Patients with painful bone metastases were randomly assigned 3:1 to receive MRgFUS sonication or placebo .
METHODS	The primary endpoint was improvement in self-reported pain score without increase of pain medication 3 months after treatment and was analyzed by Fisher 's exact test .
METHODS	Components of the response composite , Numerical Rating Scale for pain ( NRS ) and morphine equivalent daily dose intake , were analyzed by t test and Wilcoxon rank-sum test , respectively .
METHODS	Brief Pain Inventory ( BPI-QoL ) , a measure of functional interference of pain on quality of life , was compared between MRgFUS and placebo by t test .
METHODS	Statistical tests were two-sided .
RESULTS	One hundred forty-seven subjects were enrolled , with 112 and 35 randomly assigned to MRgFUS and placebo treatments , respectively .
RESULTS	Response rate for the primary endpoint was 64.3 % in the MRgFUS arm and 20.0 % in the placebo arm ( P < .001 ) .
RESULTS	MRgFUS was also superior to placebo at 3 months on the secondary endpoints assessing worst score NRS ( P < .001 ) and the BPI-QoL ( P < .001 ) .
RESULTS	The most common treatment-related adverse event ( AE ) was sonication pain , which occurred in 32.1 % of MRgFUS patients .
RESULTS	Two patients had pathological fractures , one patient had third-degree skin burn , and one patient suffered from neuropathy .
RESULTS	Overall 60.3 % of all AEs resolved on the treatment day .
CONCLUSIONS	This multicenter phase III trial demonstrated that MRgFUS is a safe and effective , noninvasive treatment for alleviating pain resulting from bone metastases in patients that have failed standard treatments .

###25018120
BACKGROUND	Intestinal immunity induced by oral poliovirus vaccine ( OPV ) is imperfect and wanes with time , permitting transmission of infection by immunised children .
BACKGROUND	Inactivated poliovirus vaccine ( IPV ) does not induce an intestinal mucosal immune response , but could boost protection in children who are mucosally primed through previous exposure to OPV .
BACKGROUND	We aimed to assess the effect of IPV on intestinal immunity in children previously vaccinated with OPV .
METHODS	We did an open-label , randomised controlled trial in children aged 1-4 years from Chinnallapuram , Vellore , India , who were healthy , had not received IPV before , and had had their last dose of OPV at least 6 months before enrolment .
METHODS	Children were randomly assigned ( 1:1 ) to receive 05 mL IPV intramuscularly ( containing 40 , 8 , and 32 D antigen units for serotypes 1 , 2 , and 3 ) or no vaccine .
METHODS	The randomisation sequence was computer generated with a blocked randomisation procedure with block sizes of ten by an independent statistician .
METHODS	The laboratory staff did blinded assessments .
METHODS	The primary outcome was the proportion of children shedding poliovirus 7 days after a challenge dose of serotype 1 and 3 bivalent OPV ( bOPV ) .
METHODS	A second dose of bOPV was given to children in the no vaccine group to assess intestinal immunity resulting from the first dose .
METHODS	A per-protocol analysis was planned for all children who provided a stool sample at 7 days after bOPV challenge .
METHODS	This trial is registered with Clinical Trials Registry of India , number CTRI/2012/09 / 003005 .
RESULTS	Between Aug 19 , 2013 , and Sept 13 , 2013 , 450 children were enrolled and randomly assigned into study groups .
RESULTS	225 children received IPV and 225 no vaccine .
RESULTS	222 children in the no vaccine group and 224 children in the IPV group had stool samples available for primary analysis 7 days after bOPV challenge .
RESULTS	In the IPV group , 27 ( 12 % ) children shed serotype 1 poliovirus and 17 ( 8 % ) shed serotype 3 poliovirus compared with 43 ( 19 % ) and 57 ( 26 % ) in the no vaccine group ( risk ratio 062 , 95 % CI 040-097 , p = 00375 ; 030 , 018-049 , p < 00001 ) .
RESULTS	No adverse events were related to the study interventions .
CONCLUSIONS	The substantial boost in intestinal immunity conferred by a supplementary dose of IPV given to children younger than 5 years who had previously received OPV shows a potential role for this vaccine in immunisation activities to accelerate eradication and prevent outbreaks of poliomyelitis .
BACKGROUND	Bill & Melinda Gates Foundation .

###24552524
OBJECTIVE	It is unclear how much the length of a cardiopulmonary resuscitation ( CPR ) training program can be reduced without ruining its effectiveness .
OBJECTIVE	The authors aimed to compare CPR skills 6 months and 1 year after training between shortened chest compression-only CPR training and conventional CPR training .
METHODS	Participants were randomly assigned to either the compression-only CPR group , which underwent a 45-minute training program consisting of chest compressions and automated external defibrillator ( AED ) use with personal training manikins , or the conventional CPR group , which underwent a 180-minute training program with chest compressions , rescue breathing , and AED use .
METHODS	Participants ' resuscitation skills were evaluated 6 months and 1 year after the training .
METHODS	The primary outcome measure was the proportion of appropriate chest compressions 1 year after the training .
RESULTS	A total of 146 persons were enrolled , and 63 ( 87.5 % ) in the compression-only CPR group and 56 ( 75.7 % ) in the conventional CPR group completed the 1-year evaluation .
RESULTS	The compression-only CPR group was superior to the conventional CPR group regarding the proportion of appropriate chest compression ( mean SD = 59.8 % 40.0 % vs. 46.3 % 28.6 % ; p = 0.036 ) and the number of appropriate chest compressions ( mean SD = 119.5 80.0 vs. 77.2 47.8 ; p = 0.001 ) .
RESULTS	Time without chest compression in the compression-only CPR group was significantly shorter than that in the conventional CPR group ( mean SD = 11.8 21.1 seconds vs. 52.9 14.9 seconds ; p < 0.001 ) .
CONCLUSIONS	The shortened compression-only CPR training program appears to help the general public retain CPR skills better than the conventional CPR training program .
BACKGROUND	UMIN-CTR UMIN000001675 .

###25983022
OBJECTIVE	Hangeshashinto ( TJ-14 , a Kampo medicine ) , which reduces the level of prostaglandin E2 and affects the cyclooxygenase activity , alleviates chemotherapy-induced oral mucositis ( COM ) .
OBJECTIVE	We conducted a double-blind , placebo-controlled , randomized comparative trial to investigate whether TJ-14 prevents and controls COM in patients with colorectal cancer .
METHODS	Ninety-three patients with colorectal cancer who developed moderate-to-severe COM ( WHO grade 1 ) during any cycle of chemotherapy using FOLFOX , FOLFIRI , and/or XELOX treatment were randomly assigned to receive either TJ-14 ( n = 46 ) or placebo ( n = 47 ) .
METHODS	Patients received the administration of placebo or TJ-14 for 2weeks at the start of the next course of chemotherapy .
METHODS	Patients were assessed three times per week for safety and for COM incidence and its severity using the WHO grading .
RESULTS	Ninety eligible patients ( TJ-14 ; 43 , placebo ; 47 ) per protocol set analysis were included in the analysis after the key-opening .
RESULTS	Although the incidence of grade 2 oral mucositis was lower for patients treated with TJ-14 compared to those treated with placebo , there was no significant difference ( 48.8 vs. 57.4 % ; p = 0.41 ) .
RESULTS	The median duration of grade 2 mucositis was 5.5 versus 10.5 days ( p = 0.018 ) .
RESULTS	No difference in other treatment toxicity was observed between the two groups , and patients exhibited high compliance in dosing administration .
CONCLUSIONS	The present study results did not meet the primary endpoint .
CONCLUSIONS	However , TJ-14 demonstrated a significant effect in the treatment of grade 2 mucositis in patients with colorectal cancer compared to the placebo .

###24722560
BACKGROUND	This preliminary study aimed to investigate the effects of the probiotic Saccharomyces boulardii on proinflammatory and anti-inflammatory cytokines in patients with diarrhea-dominant irritable bowel syndrome ( IBS-D ) .
BACKGROUND	The other objectives were to document any clinical improvement as judged by symptoms , quality of life , and histology .
METHODS	This was a randomized , double blind , placebo-controlled trial in which S. boulardii , 750 mg/day , or placebo was administered for 6 weeks in IBS-D patients , in addition to ispaghula husk standard treatment .
RESULTS	Thirty-seven patients received S. boulardii and 35 patients received the placebo .
RESULTS	As compared with placebo , the S. boulardii group showed a significant decrease in blood and tissue levels of proinflammatory cytokines interleukin-8 ( IL-8 ) and tumor necrosis factor - ( P < 0.001 ) and an increase in anti-inflammatory IL-10 levels , as well as an increase in the tissue IL-10 / IL-12 ratio ( P < 0.001 ) .
RESULTS	No significant change in the blood and tissue levels of cytokines was found in the placebo group .
RESULTS	Bowel-related IBS-D symptoms reported in the patients ' daily diary improved in both groups .
RESULTS	However , overall improvement in the quality of life was more marked in the S. boulardii group .
RESULTS	Although baseline histological findings were mild , an improvement was observed in the probiotic group in the lymphocyte and neutrophil infiltrates ( P = 0.017 and 0.018 ) , epithelial mitosis ( P = 0.003 ) , and intraepithelial lymphocytes ( P = 0.024 ) .
RESULTS	No serious adverse events were found in either group .
CONCLUSIONS	S. boulardii with ispaghula husk was superior to placebo with ispaghula husk in improving the cytokine profile , histology , and quality of life of patients with IBS-D .
CONCLUSIONS	These preliminary results need to be confirmed in a well-powered trial .

###24576068
BACKGROUND	Intermittent preventive treatment with sulphadoxine-pyrimethamine ( IPTp-SP ) is being implemented in most malaria endemic countries as a standard two-doses regimen as it reduces the risk of low birth weight ( LBW ) and the prevalence of maternal anaemia .
BACKGROUND	Nevertheless , where the risk of infection close to delivery is high because of intense transmission , a third IPTp-SP dose may further reduce the negative effects of malaria on pregnancy outcome .
METHODS	Pregnant women in the 2nd or 3rd trimester were randomized to receive either 2 ( SP2 ) or 3 doses ( SP3 ) of SP .
METHODS	Trained field workers paid home visits to the women for drug administration according to a predefined drug delivery schedule .
METHODS	Women were encouraged to attend their scheduled ANC visits and to deliver at the health facilities where the new-born was weighed .
METHODS	The prevalence of LBW ( < 2500 g ) , severe anaemia ( Hb < 8 g/dL ) and premature birth was analysed using intention-to-treat ( ITT ) and per-protocol ( PP ) analysis .
RESULTS	Data from 1274 singleton pregnancies were analysed ( 641 in the SP3 and 633 in the SP2 group ) .
RESULTS	The uptake of the intervention appeared to be low .
RESULTS	Though the prevalence of LBW in both intervention groups was similar ( adjusted Incident Rate Ratio , AIRR = 0.92 , 95 % CI : 0.69-1 .24 ) in the ITT analysis , the risk of severe anaemia was significantly lower in the SP3 group compared to the SP2 group ( AIRR = 0.38 , 95 % CI : 0.16 - 0.90 ) .
RESULTS	The PP analysis showed a trend of reduced risk of LBW , severe anaemia and premature delivery in the SP3 group , albeit the difference between two and three IPTp-SP did not reach statistical significance .
CONCLUSIONS	The risk of LBW and severe anaemia tended to be lower in the SP3 group , though this was not statistically significant , probably due to the low uptake of the intervention which reduced the power of the study .
CONCLUSIONS	Further studies are needed for establishing whether a third SP dose has a real benefit in preventing the negative effects of malaria in pregnancy in settings where transmission is markedly seasonal .

###24417745
OBJECTIVE	Safety and efficacy of long-term olanzapine treatment in Japanese patients with bipolar depression were assessed .
METHODS	An integrated analysis of data from two studies was performed in olanzapine-treated patients ( n = 165 ) with bipolar depression .
METHODS	Study 1 was a 6-week , double-blind , global study .
METHODS	Patients were randomly assigned to olanzapine or placebo followed by 18 weeks of open-label treatment .
METHODS	Study 2 was an open-label extension of Study 1 involving only Japanese patients .
METHODS	Patients assigned to Pre-olanzapine and Pre-placebo in Study 1 were treated for 24 weeks ( total olanzapine exposure 42 or 48 weeks ) and newly recruited patients ( New-olanzapine ) were treated for 48 weeks .
METHODS	Safety outcomes included treatment-emergent adverse events and changes in metabolic parameters .
METHODS	Efficacy outcome was assessed with Montgomery-sberg Depression Rating Scale score .
RESULTS	Forty-three percent of patients completed the 42 - or 48-week olanzapine treatment period .
RESULTS	The most common treatment-emergent adverse event was weight increased ( 47.9 % ) .
RESULTS	Significant increases were seen in weight ( 3.5 kg ) , and in fasting glucose ( 3.5 mg/dL ) , fasting total cholesterol ( 8.1 mg/dL ) , and fasting triglycerides ( 35.1 mg/dL ) .
RESULTS	Remission rates ( Montgomery-sberg Depression Rating Scale total score 12 at any time ) were 79.8 % for the Pre-olanzapine group , 90.2 % for the Pre-placebo group , and 85.0 % for the New-olanzapine group .
RESULTS	No patents developed mania during treatment .
CONCLUSIONS	Long-term use of olanzapine in a Japanese population with bipolar depression is associated with increases in weight and fasting metabolic measures , and also with improved depressive symptoms with avoidance of mania .
CONCLUSIONS	Clinicians must carefully consider the benefits and risks of long-term therapy with olanzapine .

###25171970
OBJECTIVE	To evaluate the prevalence of significant aortic valve stenosis ( AS ) in a randomly selected study population of elderly individuals representing the general population of Iceland .
OBJECTIVE	Furthermore , to predict the number of individuals likely to have severe AS in the future .
RESULTS	Echocardiography and computed tomography ( CT ) data from individuals who participated in the AGES-Reykjavik study were used .
RESULTS	Echocardiography data from 685 individuals ( 58 % females ) aged 67-95 years were available .
RESULTS	In both sexes combined , the prevalence for severe AS , defined as an aortic valve area index of < 0.6 cm2/m2 , in the age groups < 70 , 70-79 and 80 years was 0.92 % , 2.4 % and 7.3 % , respectively .
RESULTS	A ROC analysis on the relation between the echocardiography data and the aortic valve calcium score on CT defined a score500 to be indicative of severe AS .
RESULTS	Subsequently , in a CT study cohort of 5256 individuals the prevalence of severe AS in the same age groups was 0.80 % , 4.0 % and 9.5 % , respectively .
RESULTS	Overall , the prevalence of severe AS by echocardiography and CT in individuals70 years was 4.3 % and 5.9 % , respectively .
RESULTS	A prediction on the number of elderly70 years for the coming decades demonstrated that patients with severe AS will have increased 2.4 fold by the year 2040 and will more than triple by the year 2060 .
CONCLUSIONS	This study , in a cohort of elderly individuals representative of the general population in a Nordic country , predicts that AS will be a large health problem in the coming decades .

###24283179
OBJECTIVE	Endometrial hyperplasia is clinically important , because it can lead to abnormal uterine bleeding ( AUB ) which itself can precede endometrial cancer .
OBJECTIVE	Endometrial carcinoma is the most common malignancy of the female genital tract , occurring in about 75 % -85 % younger , perimenopausal women as endometrial hyperplasia .
OBJECTIVE	The treatment is hysterectomy or hormone therapy with progesterone .
OBJECTIVE	The aim of this study was , therefore , to compare the effect of levonorgestrel intrauterine device ( LNG-IUD ) with medroxyprogesterone acetate ( MPA ) on simple endometrial hyperplasia for fertility preservation .
METHODS	Forty women in reproductive age ( 22-47 years ) with AUB with endometrial biopsies confirming simple hyperplasia , were enrolled in this study and then randomly divided into two groups .
METHODS	All patients presented with designed special checklist which was filled with satisfaction .
METHODS	Complete history and physical examination especially blood pressure ( BP ) , body mass index ( BMI ) , breast examination , bimanual vaginal examination , and transvaginal sonography ( to measure the thickness of endometrial and exclude the other pathologic lesions ) were performed .
METHODS	In the first group , treatment was performed with MPA ( 20 mg/daily ) for ten days and in other group with LNG-IUD was prescribed .
METHODS	After three months , transvaginal sonography and biopsy of endometrium were done .
METHODS	The status of AUB and side-effects of two methods , along with the rate of satisfactory were evaluated .
RESULTS	The findings showed the significant differences in the treatment of simple hyperplasia between two groups ( LNG-IUD group vs. MPA group ) ( p < 0.047 ) .
RESULTS	Recovery of AUB in the group LNG was enhanced ( p < 0.047 ) .
RESULTS	Endometrial thickness was reduced in both groups ( p < 0.001 ) , but further reduction in LNG group was seen .
RESULTS	Also , LNG was tolerated more than MPA .
RESULTS	Side-effects of MPA were more and reached significance ( p < 0.003 ) .
RESULTS	The rate of satisfaction with LNG was higher than MPA and reached significance ( p < 0.048 ) .
CONCLUSIONS	The results of this study show that LNG-IUD is more effective than MPA in treatment of simple endometrial hyperplasia and can be helpful in young women who want to preserve their fertilities .

###25098587
BACKGROUND	Evidence of the effectiveness of printed educational messages in narrowing the gap between guideline recommendations and practice is contradictory .
BACKGROUND	Failure to screen for retinopathy exposes primary care patients with diabetes to risk of eye complications .
BACKGROUND	Screening is initiated by referral from family practitioners but adherence to guidelines is suboptimal .
BACKGROUND	We aimed to evaluate the ability of printed educational messages aimed at family doctors to increase retinal screening of primary care patients with diabetes .
METHODS	Design : Pragmatic 23 factorial cluster trial randomized by physician practice , involving 5,048 general practitioners ( with 179,833 patients with diabetes ) .
METHODS	Setting : Ontario family practitioners .
METHODS	Interventions : Reminders ( that retinal screening helps prevent diabetes-related vision loss and is covered by provincial health insurance for patients with diabetes ) with prompts to encourage screening were mailed to each physician in conjunction with a widely-read professional newsletter .
METHODS	Alternative printed materials formats were an ` outsert ' ( short , directive message stapled to the outside of the newsletter ) , and/or a two-page , evidence-based article ( ` insert ' ) and a pre-printed sticky note reminder for patients .
METHODS	Main Outcome Measure : A successful outcome was an eye examination ( which includes retinal screening ) provided to a patient with diabetes , not screened in the previous 12 months , within 90 days after visiting a family practitioner .
METHODS	Analysis accounted for clustering of doctors within practice groups .
RESULTS	No intervention effect was detected ( eye exam rates were 31.6 % for patients of control physicians , 31.3 % for the insert , 32.8 % for the outsert , 32.3 % for those who received both , and 31.2 % for those who received both plus the patient reminder with the largest 95 % confidence interval around any effect extending from -1.3 % to 1.1 % ) .
CONCLUSIONS	This large trial conclusively failed to demonstrate any impact of printed educational messages on screening uptake .
CONCLUSIONS	Despite their low cost , printed educational messages should not be routinely used in attempting to close evidence-practice gaps relating to diabetic retinopathy screening .
BACKGROUND	ISRCTN72772651 .

###25853935
BACKGROUND	Individually , levosimendan and nesiritide have been associated with substantial clinical benefits for the treatment of acute decompensated heart failure ( ADHF ) .
BACKGROUND	The aim of this study was to evaluate the efficacy of the combination of levosimendan and nesiritide for the treatment of ADHF .
METHODS	One hundred and twenty patients were randomly assigned to control , levosimendan , nesiritide or combination groups .
METHODS	The patients received 2 drugs : 1 was levosimendan or placebo A and the other was nesiritide or placebo B.
METHODS	The primary end points were rates of clinical effectiveness at 1 , 3 , 5 and 9 days after the start of therapy .
RESULTS	Nine days after the initiation of drug infusion , the clinical effectiveness rate in the combination group was better than that in the control group ( odds ratio : 1.43 , 95 % confidence interval : 0.46-2 .41 , P = 0.004 ) .
RESULTS	The combination treatment also resulted in higher rates of clinical effectiveness than individually provided levosimendan or nesiritide at 1 day ( both P = 0.04 ) or placebo at 1 , 3 or 5 days ( P = 0.002 , 0.006 and 0.009 , respectively ) .
RESULTS	The combination method was associated with fewer deaths and readmissions , as compared with the rate observed in the placebo group during the 3-month follow-up ( hazard ratio : 0.43 , 95 % confidence interval : 0.19-0 .96 , P = 0.038 ) .
CONCLUSIONS	Among patients with ADHF , intravenous infusion of levosimendan and nesiritide was superior to placebo and single-drug therapies in terms of improvements in clinical conditions during the early stages of therapy .

###25421703
BACKGROUND	The aim of the study was to compare ligation anopexy ( LA ) and conventional hemorrhoidectomy ( CH ) in treatment of second - and third-degree hemorrhoids .
METHODS	A prospective controlled randomized clinical trial included 100 patients who underwent CH ( CH group ) and 100 patients who underwent LA ( LA group ) .
METHODS	A detailed history was taken from all the patients .
METHODS	The effectiveness , safety , postoperative complications , operative time , length of hospital stay , time until first bowel movement , time until return to work , and postoperative pain score were assessed .
RESULTS	There was no significant difference between groups regarding age , sex , and preoperative symptoms .
RESULTS	The LA group had significantly shorter operative times , earlier first bowel movement , and an earlier return to work/activities .
RESULTS	The postoperative pain score in the LA group was significantly lower than that in the CH group on days 1 , 3 , 7 , and 14 after surgery .
RESULTS	There was no significant difference between groups as regards postoperative complications .
CONCLUSIONS	LA is safe , and as effective as CH in the treatment of grade II and grade III hemorrhoids , with shorter operative times , earlier mobilization , and lower postoperative pain scores .

###25329799
BACKGROUND	Repetitive transcranial magnetic stimulation of the left temporo-parietal junction area has been studied as a treatment option for auditory verbal hallucinations .
BACKGROUND	Although the right temporo-parietal junction area has also shown involvement in the genesis of auditory verbal hallucinations , no studies have used bilateral stimulation .
BACKGROUND	Moreover , little is known about durability effects .
BACKGROUND	We studied the short and long term effects of 1 Hz treatment of the left temporo-parietal junction area in schizophrenia patients with persistent auditory verbal hallucinations , compared to sham stimulation , and added an extra treatment arm of bilateral TPJ area stimulation .
METHODS	In this randomized controlled trial , 51 patients diagnosed with schizophrenia and persistent auditory verbal hallucinations were randomly allocated to treatment of the left or bilateral temporo-parietal junction area or sham treatment .
METHODS	Patients were treated for six days , twice daily for 20 minutes .
METHODS	Short term efficacy was measured with the Positive and Negative Syndrome Scale ( PANSS ) , the Auditory Hallucinations Rating Scale ( AHRS ) , and the Positive and Negative Affect Scale ( PANAS ) .
METHODS	We included follow-up measures with the AHRS and PANAS at four weeks and three months .
RESULTS	The interaction between time and treatment for Hallucination item P3 of the PANSS showed a trend for significance , caused by a small reduction of scores in the left group .
RESULTS	Although self-reported hallucination scores , as measured with the AHRS and PANAS , decreased significantly during the trial period , there were no differences between the three treatment groups .
CONCLUSIONS	We did not find convincing evidence for the efficacy of left-sided rTMS , compared to sham rTMS .
CONCLUSIONS	Moreover , bilateral rTMS was not superior over left rTMS or sham in improving AVH .
CONCLUSIONS	Optimizing treatment parameters may result in stronger evidence for the efficacy of rTMS treatment of AVH .
CONCLUSIONS	Moreover , future research should consider investigating factors predicting individual response .
BACKGROUND	Dutch Trial Register NTR1813 .

###25106094
BACKGROUND	The period from the mid-1990s to the mid-2000s saw a rapid increase in long-term sick leave in Sweden , primarily due to mental illness and often related to job burnout .
BACKGROUND	This led to an urge for effective treatment programs that could prevent the often long sick leaves .
BACKGROUND	In 2010 we presented a newly developed work-place intervention method , showing that 89 % of the intervention group had returned to work at a 1.5 year follow-up , compared to 73 % of the control group .
BACKGROUND	The main aim of this study was to assess the long-term stability of these promising results .
METHODS	Sick leave registry data from the Regional Social Insurance Office were analyzed for an additional year ( 50weeks ) beyond the original 1.5 year period ( 80weeks ) .
METHODS	Data from 68 matched pairs of intervention participants ( IP ) and controls were available .
METHODS	The proportions of participants being on full-time sick leave versus having returned to work to any extent were computed for every 10th week .
METHODS	Generalized estimating equations were used with GROUP ( IP versus controls ) as between-subjects factor , WEEKS and AGE as covariates , and return-to-work ( RTW ) as dependent variable .
METHODS	Significant differences ( Wald 2 with .05 ) was followed up with polynomial contrasts .
METHODS	Individual relapses to higher degrees of sick leave ( e.g. from 50 % to 100 % ) and whether partial RTW led to later full-time RTW , were also analyzed .
RESULTS	The omnibus test over all 130weeks showed a GROUP * WEEKS interaction effect ( p = .02 ) , indicating differential group developments in RTW , though similarly high at week 130 in both groups with 82.4 % of the IP and 77.9 % of the controls having RTW ( p = .22 ; 2-test ) .
RESULTS	A significant interaction with age led to separate analyses of the younger and older subgroups , indicating a stable pattern of superior RTW only among younger IP ( week 130 : 88.6 % vs. 69.7 % , p = .054 ; 2-test ) .
RESULTS	There was no group difference in relapses into increased degree of sick leave .
RESULTS	Part-time sick leave did not predict a later stable full-time RTW .
CONCLUSIONS	The previously reported improvement in RTW with the newly developed workplace-oriented intervention showed a long-term stability only among younger participants .

###24243927
OBJECTIVE	To assess the effectiveness of nasal saline irrigation in adult patients with chronic rhinosinusitis .
METHODS	PubMed , EMBASE , the Cochrane Library .
METHODS	A comprehensive search was performed , and 2 authors independently screened publications .
METHODS	The design of selected studies was assessed on directness of evidence and risk of bias .
RESULTS	Of 1596 publications , 1 open-label randomized trial with high directness of evidence and moderate risk of bias was included .
RESULTS	In this study , 127 patients were randomly allocated to isotonic nasal saline irrigation or isotonic nasal saline spray , as added to their usual medication .
RESULTS	The mean 20-Item Sinonasal Outcome Test ( SNOT-20 ) scores of those treated with nasal irrigation improved more than those allocated to nasal spray .
RESULTS	While the authors consider an improvement of 16 or more to be clinically meaningful , the changes from baseline in mean SNOT-20 scores of those treated with irrigation ( and the differences with those treated with nasal spray ) at 2 , 4 , and 8 weeks were 12.2 ( difference 5.5 , [ 95 % confidence interval -0.04 to 11.0 ] ) , 16.2 ( difference 8.8 [ 3.2 to 14.4 ] ) , and 15.0 ( difference 6.5 [ 0.4 to 12.6 ] ) , respectively .
RESULTS	Side effects of posttreatment nasal dripping were common but minor and did not lead to discontinuation of treatment .
CONCLUSIONS	It should be explained to adult patients with chronic rhinosinusitis that there is limited information on the relative effect of nasal saline irrigation and nasal saline spray on subjective symptom improvement , since there is only 1 trial available with a moderate risk of bias showing limited benefit of irrigation over spray .

###24734338
BACKGROUND	The paper presents clinical-radiological research on the impact of the new semi-cement luting agent in the immediately loaded implant-supported restoration on alveolar ridge resorption .
METHODS	25 patients with a partially edentulous alveolar ridge in the anterior section of the maxilla or mandible were included in the study .
METHODS	The implants were inserted with the application of traditional burs or with a Piezosurgery device supplied by Mectron .
METHODS	Taking into account the method of implant bed preparation , the scientific material was divided into two groups .
METHODS	The implants were loaded immediately with single crown restorations cemented with the Implantlink semi cement application .
METHODS	The following indices were taken into consideration : pocket depth around implant calculated at four measuring points , marginal alveolar bone loss measured using radio-visiography , the 3-degree Wachtel scale of healing of the soft tissue .
METHODS	In addition , the presence and possible width or height of any recession around the implants was measured .
METHODS	The success of the implant treatment was assessed according to the Albrektsson success criteria .
METHODS	The research results were subjected to statistical analysis .
RESULTS	The results of our study revealed no influence of the Implant-link semi cement on the crestal bone level , regardless of the bone bed preparation technique .

###24664356
BACKGROUND	We developed and validated a Patient Satisfaction with Cancer-Related Care ( PSCC ) measure using classical test theory methods .
BACKGROUND	The present study applied item response theory ( IRT ) analysis to determine item-level psychometric properties , facilitate development of short forms , and inform future applications for the PSCC .
METHODS	We applied unidimensional IRT models to PSCC data from 1,296 participants ( 73 % female ; 18 to 86 years ) .
METHODS	An unconstrained graded response model ( GRM ) and a Rasch Model were fitted to estimate indices for model comparison using likelihood ratio ( LR ) test and information criteria .
METHODS	We computed item and latent trait parameter estimates , category and operating characteristic curves , and tested information curves for the better fitting model .
RESULTS	The GRM fitted the data better than the Rasch Model ( LR = 828 , df = 17 , p < 0.001 ) .
RESULTS	The log-likelihood ( -17,390.38 vs. -17,804.26 ) was larger , and the AIC and BIC were smaller for the GRM compared to the Rash Model ( AIC = 34,960.77 vs. 35,754.73 ; BIC = 35,425.80 vs. 36,131.92 ) .
RESULTS	Item parameter estimates ( IPEs ) showed substantial variation in items ' discriminating power ( 0.94 to 2.18 ) .
RESULTS	Standard errors of the IPEs were small ( threshold parameters mostly around 0.1 ; discrimination parameters 0.1 to 0.2 ) , confirming the precision of the IPEs .
CONCLUSIONS	The GRM provides precise IPEs that will enable comparable scores from different subsets of items , and facilitate optimal selections of items to estimate patients ' latent satisfaction level .
CONCLUSIONS	Given the large calibration sample , the IPEs can be used in settings with limited resources ( e.g. , smaller samples ) to estimate patients ' satisfaction .

###24791752
OBJECTIVE	Glutathione ( GSH ) , the most abundant endogenous antioxidant , is a critical regulator of oxidative stress and immune function .
OBJECTIVE	While oral GSH has been shown to be bioavailable in laboratory animal models , its efficacy in humans has not been established .
OBJECTIVE	Our objective was to determine the long-term effectiveness of oral GSH supplementation on body stores of GSH in healthy adults .
METHODS	A 6-month randomized , double-blinded , placebo-controlled trial of oral GSH ( 250 or 1,000 mg/day ) on GSH levels in blood , erythrocytes , plasma , lymphocytes and exfoliated buccal mucosal cells was conducted in 54 non-smoking adults .
METHODS	Secondary outcomes on a subset of subjects included a battery of immune markers .
RESULTS	GSH levels in blood increased after 1 , 3 and 6 months versus baseline at both doses .
RESULTS	At 6 months , mean GSH levels increased 30-35 % in erythrocytes , plasma and lymphocytes and 260 % in buccal cells in the high-dose group ( P < 0.05 ) .
RESULTS	GSH levels increased 17 and 29 % in blood and erythrocytes , respectively , in the low-dose group ( P < 0.05 ) .
RESULTS	In most cases , the increases were dose and time dependent , and levels returned to baseline after a 1-month washout period .
RESULTS	A reduction in oxidative stress in both GSH dose groups was indicated by decreases in the oxidized to reduced glutathione ratio in whole blood after 6 months .
RESULTS	Natural killer cytotoxicity increased > twofold in the high-dose group versus placebo ( P < 0.05 ) at 3 months .
CONCLUSIONS	These findings show , for the first time , that daily consumption of GSH supplements was effective at increasing body compartment stores of GSH .

###25751829
OBJECTIVE	To compare femtosecond laser-assisted cataract surgery without the use of ophthalmic viscosurgical device ( OVD ) with standard phacoemulsification using OVD .
METHODS	This was a prospective , randomized , single-center trial of 37 patients ( 74 eyes ) diagnosed as having significant cataract in both eyes .
METHODS	Randomly , one eye underwent standard phacoemulsification with OVD ( the OVD group ) ; this group acted as controls .
METHODS	The other eye was treated with the femtosecond laser ; the subsequent manual part of the procedure was performed without OVD ( non-OVD group ) .
METHODS	Time of surgery , amount of fluid used during phacoemulsification , central corneal thickness , intraocular pressure , endothelial cell count , and visual acuity were documented over the 6-month follow-up .
RESULTS	There were no major complications and no significant difference in overall surgery time ( non-OVD : 375 81 seconds ; OVD : 362 43 seconds ; P = .713 ) and in the quantity of fluid passing through the eye ( non-OVD : 187 35 mL ; OVD : 186 27 mL ; P = .952 ) between groups .
RESULTS	Endothelial cell loss after 6 months was not significantly different between groups ( non-OVD : -2.4 % ; OVD : -2.7 % ; P = .880 ) .
RESULTS	Central corneal thickness was not different at 1 week postoperatively between groups ( non-OVD : 575 45 m ; OVD : 573 46 m ; P = .820 ) .
RESULTS	Three patients in the OVD group and one patient in the non-OVD group experienced intraocular pressure greater than 25 mm Hg at 1 day postoperatively .
RESULTS	There were no significant differences in corrected distance visual acuity between groups ( logMAR non-OVD : 0.024 ; OVD : 0.038 ; P = .461 ) .
CONCLUSIONS	Femtosecond laser-assisted treatment allows the cataract surgeon to perform phacoemulsification and intraocular lens implantation without the use of OVD at no additional risk to the corneal endothelium .
CONCLUSIONS	Furthermore , there was a tendency toward fewer increases in intraocular pressure in patients treated with the femtosecond laser .

###24377214
OBJECTIVE	To evaluate the clinical efficacy and safety of the three therapies of strong stimulation for children peripheral facial palsy so as to deal with the problem on the inactive acceptance of acupuncture in children .
METHODS	Eighty cases of children peripheral facial palsy were randomized into a moxa stick group ( group A ) and a group with three therapies of strong stimulation ( group B ) .
METHODS	Baihui ( GV 20 ) , Sibai ( ST 2 ) , Dicang ( ST 4 ) , Jiache ( ST 6 ) and the other acupoints were selected in the two groups and stimulated with half-needling technique .
METHODS	In the group A , 3 moxa sticks were bunched together for surrounding moxibustion over one of Dazhui ( GV 14 ) , Yangbai ( GB 14 ) , Xiaguan ( ST 7 ) and Jiache ( ST 6 ) in each treatment .
METHODS	In the group B , the strong pricking therapy , strong cupping therapy and strong moxibustion were adopted at the same acupoints as the group A.
METHODS	The treatment was given twice every day in the first 5 days .
METHODS	Afterwards , the clinical efficacy was analyzed statistically .
METHODS	The treatment was kept on for the effective case .
METHODS	Those with failed effect were transferred to the other group .
METHODS	Since the 6th day , the treatment was given once every day .
METHODS	In 15 days , the clinical efficacy was compared between the two groups and House-Brackmann ( H-B ) facial nerve function grade was compared before and after treatment .
RESULTS	In 5 days of treatment , the total effective rate was 94.7 % ( 36/38 ) in the group B , which was better than 52.4 % ( 22/42 ) in the group A , ( P < 0.001 ) .
RESULTS	In 15 days of treatment , the cured rate and the total effective rate in the group B were 67.3 % ( 35/52 ) and 96.2 % ( 50/52 ) , which were better than 9.5 % ( 2/21 ) and 85.7 % ( 18/21 ) in the group A , respectively ( P < 0.001 , P < 0.05 ) .
RESULTS	Additionally , the result of H-B facial nerve function grade in the group B was superior to the group A ( P < 0.001 ) .
CONCLUSIONS	The half-needling technique and the three therapies of strong stimulation in combination achieve the superior efficacy on children peripheral facial palsy as compared with the half-needling technique combined with moxa stick therapy .
CONCLUSIONS	And the obvious adverse reaction has not been found .

###24480677
OBJECTIVE	Tofacitinib , an orally administered Janus kinase inhibitor , blocks signaling through - chain-containing cytokines ( interleukins 2 , 4 , 7 , 9 , 15 , and 21 ) .
OBJECTIVE	We performed a phase 2 trial to measure its efficacy in patients with moderate-to-severe active Crohn 's disease .
METHODS	Patients ( N = 139 ; age , 18 y ) with moderate-to-severe active Crohn 's disease were assigned randomly to groups given 1 mg ( n = 36 ) , 5 mg ( n = 34 ) , or 15 mg ( n = 35 ) tofacitinib or placebo ( n = 34 ) , twice daily for 4 weeks , at 48 centers in 12 countries .
METHODS	The primary end point was the proportion of clinical responders at week 4 ( decrease from baseline in the Crohn 's Disease Activity Index score of 70 points [ Response-70 ] ) .
METHODS	Secondary end points included clinical remission ( Crohn 's Disease Activity Index score of < 150 points ) at week4 .
RESULTS	A clinical response was observed in 36 % ( P = .467 ) , 58 % ( P = .466 ) , and 46 % ( P .999 ) of patients given the 1 - , 5 - , and 15-mg doses of tofacitinib , compared with 47 % of patients given placebo .
RESULTS	Clinical remission was observed in 31 % ( P = .417 ) , 24 % ( P = .776 ) , and 14 % ( P = .540 ) of patients given the 1 - , 5 - , and 15-mg doses of tofacitinib , compared with 21 % of patients given placebo .
RESULTS	The 15-mg dose of tofacitinib reduced levels of C-reactive protein and fecal calprotectin from baseline .
RESULTS	Adverse and serious adverse events were similar among groups .
RESULTS	Dose-dependent increases in low - and high-density lipoprotein cholesterol were observed in patients given the 5 - or 15-mg doses of tofacitinib .
CONCLUSIONS	There were no significant differences in the percentage of patients with moderate-to-severe active Crohn 's disease who achieved clinical responses ( Response-70 ) or clinical remission after 4 weeks ' administration of tofacitinib ( 1 , 5 , or 15 mg ) or placebo twice daily .
CONCLUSIONS	However , a large percentage of patients given placebo achieved Response-70 or remission .
CONCLUSIONS	Reductions in C-reactive protein and fecal calprotectin levels among patients given the 15-mg dose of tofacitinib indicate its biologic activity .
CONCLUSIONS	ClinicalTrials.gov number : NCT00615199 .

###24564888
BACKGROUND	Triple negative breast cancer ( TNBC ) has higher rates of recurrence and distant metastasis , and poorer outcome as compared to non-TNBC .
BACKGROUND	Aberrant activation of WNT signaling has been detected in TNBC , which might be important for triggering oncogenic conversion of breast epithelial cell .
BACKGROUND	Therefore , we directed our focus on identifying the WNT ligand and its underlying mechanism in TNBC cells .
METHODS	We performed large-scale analysis of public microarray data to screen the WNT ligands and the clinical significance of the responsible ligand in TNBC .
METHODS	WNT5B was identified and its overexpression in TNBC was confirmed by immunohistochemistry staining , Western blot and ELISA .
METHODS	ShRNA was used to knockdown WNT5B expression ( shWNT5B ) .
METHODS	Cellular functional alteration with shWNT5B treatment was determined by using wound healing assay , mammosphere assay ; while cell cycle and apoptosis were examined by flowcytometry .
METHODS	Mitochondrial morphology was photographed by electron microscope .
METHODS	Biological change of mitochondria was detected by RT-PCR and oxygen consumption assay .
METHODS	Activation of WNT pathway and its downstream targets were evaluated by liciferase assay , immunohistochemistry staining and immunoblot analysis .
METHODS	Statistical methods used in the experiments besides microarray analysis was two-tailed t-test .
RESULTS	WNT5B was elevated both in the tumor and the patients ' serum .
RESULTS	Suppression of WNT5B remarkably impaired cell growth , migration and mammosphere formation .
RESULTS	Additionally , G0/G1 cell cycle arrest and caspase-independent apoptosis was observed .
RESULTS	Study of the possible mechanism indicated that these effects occurred through suppression of mitochondrial biogenesis , as evidenced by reduced mitochondrial DNA ( MtDNA ) and compromised oxidative phosphorylation ( OXPHOS ) .
RESULTS	In Vivo and in vitro data uncovered that WNT5B modulated mitochondrial physiology was mediated by MCL1 , which was regulated by WNT / - catenin responsive gene , Myc .
RESULTS	Clinic data analysis revealed that both WNT5B and MCL1 are associated with enhanced metastasis and decreased disease-free survival .
CONCLUSIONS	All our findings suggested that WNT5B/MCL1 cascade is critical for TNBC and understanding its regulatory apparatus provided valuable insight into the pathogenesis of the tumor development and the guidance for targeting therapeutics .

###24553032
BACKGROUND	Radial head subluxation , also known as ` pulled elbow ' , ` dislocated elbow ' or ` nursemaid 's elbow ' , is one of the most common upper extremity injuries in young children and a common reason to visit Emergency Department ( ED ) .
OBJECTIVE	To compare supination of the wrist followed by flexion of the elbow ( the traditional reduction technique ) to hyperpronation of the wrist in the reduction of radial head subluxations ( nursemaid 's elbow ) maneuvers in children presented to ED with painful pronation and to determine which method is less painful by children .
METHODS	This prospective randomize study involved a consecutive sampling of children between 1-5 year old who were presented to the ED with painful pronation .
METHODS	The initial procedure was repeated if baseline functioning did not return 20 minutes after the initial reduction attempt .
METHODS	Failure of that technique 30 minutes after the initial reduction attempt resulted in a cross-over to the alternate method of reduction .
METHODS	Datas were analyzed using SPSS for Windows 16.0 .
METHODS	Mean , standard deviation , independent samples t test , Chi-square test , and paired t test were used in the assessment of pain scores before and after reduction .
RESULTS	When pain scores before and after reduction were compared between groups to determine which technique is less painful by children , no significant difference was found between groups .
CONCLUSIONS	It was found that in the reduction of radial head subluxations , the hyperpronation technique is more effective in children who were presented to ED with painful pronation compared with supination-flexion .
CONCLUSIONS	However , there was no significant difference between these techniques in terms of pain .

###25030779
BACKGROUND	Isomaltulose attenuates postprandial glucose and insulin concentrations compared with sucrose in patients with type 2 diabetes mellitus ( T2DM ) .
BACKGROUND	However , the mechanism by which isomaltulose limits postprandial hyperglycemia has not been clarified .
OBJECTIVE	The objective was therefore to assess the effects of bolus administration of isomaltulose on glucose metabolism compared with sucrose in T2DM .
METHODS	In a randomized , double-blind , crossover design , 11 participants with T2DM initially underwent a 3-h euglycemic-hyperinsulinemic ( 0.8 mU kg ( -1 ) min ( -1 ) ) clamp that was subsequently combined with 1 g/kg body wt of an oral ( 13 ) C-enriched isomaltulose or sucrose load .
METHODS	Hormonal responses and glucose kinetics were analyzed during a 4-h postprandial period .
RESULTS	Compared with sucrose , absorption of isomaltulose was prolonged by 50 min ( P = 0.004 ) .
RESULTS	Mean plasma concentrations of insulin , C-peptide , glucagon , and glucose-dependent insulinotropic peptide were 10-23 % lower ( P < 0.05 ) .
RESULTS	In contrast , glucagon-like peptide 1 ( GLP-1 ) was 64 % higher ( P < 0.001 ) after isomaltulose ingestion , which results in an increased insulin-to-glucagon ratio ( P < 0.001 ) compared with sucrose .
RESULTS	The cumulative amount of systemic glucose appearance was 35 % lower after isomaltulose than after sucrose ( P = 0.003 ) because of the reduction in orally derived and endogenously produced glucose and a higher first-pass splanchnic glucose uptake ( SGU ) .
RESULTS	Insulin action was enhanced after isomaltulose compared with sucrose ( P = 0.013 ) .
CONCLUSIONS	Ingestion of slowly absorbed isomaltulose attenuates postprandial hyperglycemia by reducing oral glucose appearance , inhibiting endogenous glucose production ( EGP ) , and increasing SGU compared with ingestion of rapidly absorbed sucrose in patients with T2DM .
CONCLUSIONS	In addition , GLP-1 secretion contributes to a beneficial shift in the insulin-to-glucagon ratio , suppression of EGP , and enhancement of SGU after isomaltulose consumption .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01070238 .

###24866613
OBJECTIVE	Ultrasound guidance may decrease the procedural time for many peripheral nerve blocks compared to nerve stimulation , but these studies have generally excluded obese patients .
OBJECTIVE	This single-blinded randomized clinical trial was designed to compare procedural times and related outcomes for ultrasound - versus nerve stimulation-guided lateral popliteal-sciatic nerve blockade specifically in obese patients .
METHODS	With Institutional Review Board approval and informed consent , patients with a body mass index greater than 30 kg/m ( 2 ) who were scheduled for foot/ankle surgery and desiring a peripheral nerve block were offered enrollment .
METHODS	Study patients were randomly assigned to receive a lateral popliteal-sciatic nerve block under either ultrasound or nerve stimulation guidance .
METHODS	The patient and assessor were blinded to group assignment .
METHODS	The primary outcome was procedural time in seconds .
METHODS	Secondary outcomes included number of needle redirections , procedure-related pain , patient satisfaction with the block , success rate , sensory and motor onset times , block duration , and complication rates .
RESULTS	Twenty-four patients were enrolled and completed the study .
RESULTS	All patients had successful nerve blocks .
RESULTS	The mean procedural times ( SD ) were 577 ( 57 ) seconds under nerve stimulation and 206 ( 40 ) seconds with ultrasound guidance ( P < .001 ; 95 % confidence interval for difference , 329-412 seconds ) .
RESULTS	Patients in the ultrasound group had fewer needle redirections and less procedure-related pain , required less opioids , and were more satisfied with their block procedures .
RESULTS	There were no statistically significant differences in other outcomes .
CONCLUSIONS	The results of this study show that , for obese patients undergoing lateral popliteal-sciatic nerve blocks , ultrasound guidance reduces the procedural time and procedure-related pain and increases patient satisfaction compared to nerve stimulation while providing similar block characteristics .

###25641237
OBJECTIVE	To determine the extent that social variables influence cognitive development of very low birth weight ( VLBW ) infants across the preschool years .
METHODS	Participants were VLBW ( 500-1250 g ) children enrolled in the Caffeine for Apnea of Prematurity randomized trial between 1999 and 2004 .
METHODS	We investigated the relationships between 4 potential social advantages : higher maternal education , higher paternal education , caregiver employment , and 2 biologic parents in the same home -- and gain in cognitive scores .
METHODS	Cognitive assessments were performed at the corrected ages of 18 months ( Mental Development Index score on the Bayley Scales of Infant Development II ) and 5 years ( Full Scale IQ on the Wechsler Preschool and Primary Scale of Intelligence III ) .
METHODS	Cognitive gain was computed by subtracting each individual 18-month Mental Development Index score from the corresponding Full Scale IQ at 5 years .
RESULTS	Data were available for 1347 children .
RESULTS	Mean ( SD ) cognitive scores were 90.8 ( 15.7 ) at 18 months and 98.9 ( 14.5 ) at 5 years .
RESULTS	Multivariable regression showed that higher maternal education , higher paternal education , and caregiver employment had independent and additive effects of similar size on cognitive gain ( P < .001 ) ; the mean cognitive gain between 18 months and 5 years increased by 3.6 points in the presence of each of these advantages .
RESULTS	When all 3 were present , cognitive scores improved on average by 10.9 points compared with children without any of these advantages .
CONCLUSIONS	In VLBW children , a count of 3 social advantages strongly predicts gains in cognitive scores across the preschool years .

###24700386
BACKGROUND	Detectable levels of troponins are often found in serum of patients with atrial fibrillation ( AF ) , and recent reports suggest that Tn concentrations are independently related to patient prognosis .
OBJECTIVE	We hypothesized that treatment with common rate-reducing drugs might lower the levels of cardiac troponin T ( TnT ) in patients with permanent AF .
OBJECTIVE	We also wanted to investigate whether the different drugs would impact the Tn levels differently .
METHODS	Sixty patients were included ( mean age 71 9 years , 18 women ) in this randomized crossover study .
METHODS	All patients had stable , permanent AF without ischemic heart disease or congestive heart failure .
METHODS	Diltiazem 360 mg , verapamil 240 mg , metoprolol 100 mg , and carvedilol 25 mg were administered once daily for 3 weeks , in a randomized sequence .
METHODS	At baseline and on the last day of each treatment period , TnT concentrations were measured at rest and after a maximal exercise test .
RESULTS	TnT was detectable in all patients .
RESULTS	In 22 % of the patients , TnT concentrations were above the threshold normally used for diagnosing myocardial infarction .
RESULTS	All drugs reduced the levels of TnT significantly compared with baseline ( P < 0.001 for all ) , but there were no significant differences between the treatments .
RESULTS	Levels of TnT increased significantly in response to exercise testing ( P < 0.001 for all ) .
CONCLUSIONS	Elevated TnT was demonstrated in a large proportion of stable patients with permanent AF without ischemic heart disease .
CONCLUSIONS	A moderate reduction of heart rate by the study drugs was associated with a significant reduction in levels of TnT .

###25130518
OBJECTIVE	Pain and depression are prevalent and treatable symptoms among patients with cancer , yet they are often undetected and undertreated .
OBJECTIVE	The Indiana Cancer Pain and Depression ( INCPAD ) trial demonstrated that telecare management can improve pain and depression outcomes .
OBJECTIVE	This article investigates the incremental cost effectiveness of the INCPAD intervention .
METHODS	The INCPAD trial was conducted in 16 community-based urban and rural oncology practices in Indiana .
METHODS	Of the 405 participants , 202 were randomized to the intervention group and 203 to the usual-care group .
METHODS	Intervention costs were determined , and effectiveness outcomes were depression-free days and quality-adjusted life years .
RESULTS	The intervention group was associated with a yearly increase of 60.3 depression-free days ( S.E. = 15.4 ; P < 0.01 ) and an increase of between 0.033 and 0.066 quality-adjusted life years compared to the usual care group .
RESULTS	Total cost of the intervention per patient was US$ 1189 , which included physician , nurse care manager and automated monitoring set-up and maintenance costs .
RESULTS	Incremental cost per depression-free day was US$ 19.72 , which yields a range of US$ 18,018 to US$ 36,035 per quality-adjusted life year when converted to that metric .
RESULTS	When measured directly , the incremental cost per quality-adjusted life year ranged from US$ 10,826 based on the modified EQ-5D to US$ 73,286.92 based on the SF-12 .
CONCLUSIONS	Centralized telecare management , coupled with automated symptom monitoring , appears to be a cost effective intervention for managing pain and depression in cancer patients .

###25909969
BACKGROUND	The administration of uterotonic agents during cesarean delivery is highly variable .
BACKGROUND	The authors hypothesized a `` rule of threes '' algorithm , featuring oxytocin 3 IU , timed uterine tone evaluations , and a systematic approach to alternative uterotonic agents , would reduce the oxytocin dose required to obtain adequate uterine tone .
METHODS	Sixty women undergoing elective cesarean delivery were randomized to receive a low-dose bolus or continuous infusion of oxytocin .
METHODS	To blind participants , the rule group simultaneously received intravenous oxytocin ( 3 IU/3 ml ) and a `` wide-open '' infusion of 0.9 % normal saline ( 500 ml ) ; the standard care group received intravenous 0.9 % normal saline ( 3 ml ) and a `` wide-open '' infusion of oxytocin ( 30 IU in 0.9 % normal saline/500 ml ) .
METHODS	Uterine tone was assessed at 3 , 6 , 9 , and 12 min , and if inadequate , additional uterotonic agents were administered .
METHODS	Uterine tone , total dose and timing of uterotonic agent use , maternal hemodynamics , side effects , and blood loss were recorded .
RESULTS	Adequate uterine tone was achieved with lower oxytocin doses in the rule versus standard care group ( mean , 4.0 vs. 8.4 IU ; point estimate of the difference , 4.4 1.0 IU ; 95 % CI , 2.60 to 6.15 ; P < 0.0001 ) .
RESULTS	No additional oxytocin or alternative uterotonic agents were needed in either group after 6 min .
RESULTS	No differences in the uterine tone , maternal hemodynamics , side effects , or blood loss were observed .
CONCLUSIONS	A `` rule of threes '' algorithm using oxytocin 3 IU results in lower oxytocin doses when compared with continuous-infusion oxytocin in women undergoing elective cesarean delivery .

###24477242
OBJECTIVE	Glucagon-like peptide-1 ( GLP-1 ) and the insulin-like growth factor ( IGF ) system are important factors in metabolic regulation and cellular growth .
OBJECTIVE	Interactions between the systems exist but these are vaguely explored and only in vitro , where GLP-1 has been reported to stimulate IGF-binding protein 1 ( IGFBP-1 ) .
OBJECTIVE	This study , therefore , aimed to elucidate the effects of GLP-1 on IGF-I and the IGFBPs , which regulate IGF-I bioactivity .
METHODS	We investigated the effects of a 2-hour intravenous GLP-1 infusion on the IGF system in 12 overnight fasted healthy humans , using a randomized , double-blinded , cross-over study design .
METHODS	Serum samples were assessed for immunoreactive levels of IGF-I , IGFBP-1 and -2 as well as for bioactive IGF-I , which was determined by a cell-based IGF-I kinase receptor activation assay .
RESULTS	GLP-1 infusion markedly increased insulin levels ( p < 0.0001 ) , reduced IGFBP-1 levels ( p = 0.02 ) , and tended to increase IGF-I bioactivity ( p = 0.06 ) .
RESULTS	There were no significant changes in IGFBP-2 or immunoreactive IGF-I levels .
CONCLUSIONS	In this short-term study , GLP-1 reduced IGFBP-1 levels in vivo and tended to increase IGF-I bioactivity .
CONCLUSIONS	The IGFBP-1 outcome is opposite to the in vitro situation , hereby demonstrating that in vivo the ability of GLP-1 to stimulate insulin and hereby suppress IGFBP-1 outweighs any direct stimulatory effects of GLP-1 on IGFBP-1 .

###24450992
BACKGROUND	Diabetes self-care by patients has been shown to assist in the reduction of disease severity and associated medical costs .
BACKGROUND	We compared the effectiveness of two different diabetes self-care interventions on glycemic control in a racially/ethnically diverse population .
BACKGROUND	We also explored whether reductions in glycated hemoglobin ( HbA1c ) will be more marked in minority persons .
METHODS	We conducted an open-label randomized controlled trial of 376 patients with type 2 diabetes aged 18years and whose last measured HbA1c was 7.5 % ( 58mmol/mol ) .
METHODS	Participants were randomized to : 1 ) a Chronic Disease Self-Management Program ( CDSMP ; n = 101 ) ; 2 ) a diabetes self-care software on a personal digital assistant ( PDA ; n = 81 ) ; 3 ) a combination of interventions ( CDSMP + PDA ; n = 99 ) ; or 4 ) usual care ( control ; n = 95 ) .
METHODS	Enrollment occurred January 2009-June 2011 at seven regional clinics of a university-affiliated multi-specialty group practice .
METHODS	The primary outcome was change in HbA1c from randomization to 12months .
METHODS	Data were analyzed using a multilevel statistical model .
RESULTS	Average baseline HbA1c in the CDSMP , PDA , CDSMP + PDA , and control arms were 9.4 % , 9.3 % , 9.2 % , and 9.2 % , respectively .
RESULTS	HbA1c reductions at 12months for the groups averaged 1.1 % , 0.7 % , 1.1 % , and 0.7 % , respectively and did not differ significantly from baseline based on the model ( P = .771 ) .
RESULTS	Besides the participants in the PDA group reporting eating more high-fat foods compared to their counterparts ( P < .004 ) , no other significant differences were observed in participants ' diabetes self-care activities .
RESULTS	Exploratory sub-analysis did not reveal any marked reductions in HbA1c for minority persons but rather modest reductions for all racial/ethnic groups .
CONCLUSIONS	Although behavioral and technological interventions can result in some modest improvements in glycemic control , these interventions did not fare significantly better than usual care in achieving glycemic control .
CONCLUSIONS	More research is needed to understand how these interventions can be most effective in clinical practice .
CONCLUSIONS	The reduction in HbA1c levels found in our control group that received usual care also suggests that good routine care in an integrated healthcare system can lead to better glycemic control .
BACKGROUND	Clinicaltrials.gov Identifier : NCT01221090 .

###24244635
BACKGROUND	Immunological non-responders ( INRs ) lacked CD4 increase despite HIV-viremia suppression on HAART and had an increased risk of disease progression .
BACKGROUND	We assessed immune reconstitution profile upon intensification with maraviroc in INRs .
METHODS	We designed a multi-centric , randomized , parallel , open label , phase 4 superiority trial .
METHODS	We enrolled 97 patients on HAART with CD4 + < 200/L and/or CD4 + recovery 25 % and HIV-RNA < 50 cp/mL .
METHODS	Patients were randomized 1:1 to HAART + maraviroc or continued HAART .
METHODS	CD4 + and CD8 + CD45 + RA/RO , Ki67 expression and plasma IL-7 were quantified at W0 , W12 and W48 .
RESULTS	By W48 both groups displayed a CD4 increase without a significant inter-group difference .
RESULTS	A statistically significant change in CD8 favored patients in arm HAART + maraviroc versus HAART at W12 ( p = .009 ) and W48 ( p = .025 ) .
RESULTS	The CD4 > 200/L and CD4 > 200/L + CD4 gain 25 % end-points were not satisfied at W12 ( p = .24 and p = .619 ) nor at W48 ( p = .076 and p = .236 ) .
RESULTS	Patients continuing HAART displayed no major changes in parameters of T-cell homeostasis and activation .
RESULTS	Maraviroc-receiving patients experienced a significant rise in circulating IL-7 by W48 ( p = .01 ) , and a trend in temporary reduction in activated HLA-DR + CD38 + CD4 + by W12 ( p = .06 ) that was not maintained at W48 .
CONCLUSIONS	Maraviroc intensification in INRs did not have a significant advantage in reconstituting CD4 T-cell pool , but did substantially expand CD8 .
CONCLUSIONS	It resulted in a low rate of treatment discontinuations .
BACKGROUND	ClinicalTrials.gov NCT00884858 http://clinicaltrials.gov/show/NCT00884858 .

###25015689
BACKGROUND	Matrix - carboxyglutamate protein is an inhibitor of cardiovascular calcification .
BACKGROUND	The objective of this substudy of the Aortic Stenosis Progression Observation : Measuring Effects of Rosuvastatin ( ASTRONOMER ) trial was to examine the relationship between total ( ie , carboxylated [ active ] form + uncarboxylated [ inactive ] form ) circulating desphosphorylated matrix - carboxyglutamate protein ( dpMGP ) level and the progression rate of aortic stenosis ( AS ) .
METHODS	Among the patients included in the ASTRONOMER trial , 215 patients had measures of baseline circulating total dpMGP level and an echocardiographic follow-up ( mean follow-up : 3.5 1.3 years ) .
METHODS	Progression of AS was assessed according to the measurement of the annualized increase in peak aortic jet velocity .
RESULTS	In the whole cohort , baseline dpMGP level was associated with faster progression rate of peak aortic jet velocity ( r = 0.16 ; P = 0.02 ) in individual analysis but not in multivariable analysis ( P = 0.40 ) .
RESULTS	However , there was a significant interaction ( P = 0.03 ) between dpMGP level and age , with respect to the effect on AS progression .
RESULTS	After dichotomization according to median value of age ( ie , 57 years old ) , total dpMGP level was associated with faster AS progression rate ( r = 0.24 ; P = 0.008 ) in the younger patients , and this association remained significant in multivariable analysis ( P = 0.04 ) , but not in the older ones .
RESULTS	The independent correlates of dpMGP level were fasting glucose ( P = 0.009 ) and oxidized low-density lipoprotein ( P = 0.01 ) .
CONCLUSIONS	This is the first prospective study to demonstrate a relationship between increased circulating levels of total dpMGP and faster progression rate of AS in younger individuals .
CONCLUSIONS	Future studies are needed to determine if dpMGP is simply a marker or a contributing factor to ectopic mineralization of aortic valve .

###25018142
OBJECTIVE	Endoscopic variceal ligation ( EVL ) is recommended to treat esophageal varices ( EV ) in cirrhosis and portal hypertension .
OBJECTIVE	A program of endoscopic surveillance is not clearly established .
OBJECTIVE	The aim of this prospective randomized trial was to assess the most effective timing of endoscopic monitoring after variceal eradication and its impact on the patient 's outcome and on the costs .
METHODS	A hundred and two cirrhotic patients with esophageal varices treated by EVL were evaluated .
METHODS	After variceal eradication patients were randomized to receive first endoscopic control at 3 ( Group 1 ) and 6 ( Group 2 ) months respectively .
RESULTS	Variceal obliteration was achieved in all patients .
RESULTS	Variceal recurrence was observed in 28 cases at the first control ( 29.1 % ) without difference between the two groups ( 32 % vs 29 % in group 1 and 2 respectively , p = 0.75 ) .
RESULTS	The incidence of large varices is similar in the two groups ( 33 % vs 38 % respectively ) .
RESULTS	Using a multivariate analysis , medical therapy with B blockers was the only independent predictor of lowest risk of variceal recurrence [ OR 2.30 , 95 % CI ( 1.68-3 .26 ) ] .
RESULTS	Bleeding related to recurrent varices occurred in 3.1 % of cases and was associated with portal thrombosis .
RESULTS	Child Pugh score 8 was the only predictor of mortality ( p = 0.0002 ) .
CONCLUSIONS	Recurrence of varices after banding ligation is not rare but it is associated with a low risk of variceal progression and bleeding .
CONCLUSIONS	Accordingly , a first endoscopic control at 6 months after variceal eradication associated with a good risk stratification might be a cost-effective strategy of monitoring .

###24388320
OBJECTIVE	To determine the incidence and risk factors for readmission to the intensive care unit ( ICU ) among preterm infants who required mechanical ventilation at birth .
METHODS	We studied preterm newborns ( birth weight 500-1250 g ) who required mechanical ventilation at birth and were enrolled in a multicenter trial of inhaled nitric oxide therapy .
METHODS	Patients were assessed up to 4.5 years of age via annual in-person evaluations and structured telephone interviews .
METHODS	Univariate and multivariable analyses of baseline and birth hospitalization predictors of ICU readmission were performed .
RESULTS	Of 512 subjects providing follow-up data , 58 % were readmitted to the hospital ( 51 % of these had multiple readmissions , averaging 3.9 readmissions per subject ) , 19 % were readmitted to an ICU , and 12 % required additional mechanical ventilation support .
RESULTS	In univariate analyses , ICU readmission was more common among male subjects ( OR 2.01 ; 95 % CI 1.27-3 .18 ) , infants with grade 3-4 intracranial hemorrhage ( OR 2.13 ; 95 % CI 1.23-3 .69 ) , increasing duration of birth hospitalization ( OR 1.01 per day ; 95 % CI 1.00-1 .02 ) , and prolonged oxygen therapy ( OR 1.01 per day ; 95 % CI 1.00-1 .01 ) .
RESULTS	In the first year after birth hospitalization , children readmitted to an ICU incurred greater health care costs ( median $ 69,700 vs $ 30,200 for subjects admitted to the ward and $ 9600 for subjects never admitted ) .
CONCLUSIONS	Small preterm infants who were mechanically ventilated at birth have substantial risk for readmission to an ICU and late mechanical ventilation , require extensive health care resources , and incur high treatment costs .

###24982463
OBJECTIVE	Although often investigated in locally advanced esophageal cancer ( EC ) , the impact of neoadjuvant chemoradiotherapy ( NCRT ) in early stages is unknown .
OBJECTIVE	The aim of this multicenter randomized phase III trial was to assess whether NCRT improves outcomes for patients with stage I or II EC .
METHODS	The primary end point was overall survival .
METHODS	Secondary end points were disease-free survival , postoperative morbidity , in-hospital mortality , R0 resection rate , and prognostic factor identification .
METHODS	From June 2000 to June 2009 , 195 patients in 30 centers were randomly assigned to surgery alone ( group S ; n = 97 ) or NCRT followed by surgery ( group CRT ; n = 98 ) .
METHODS	CRT protocol was 45 Gy in 25 fractions over 5 weeks with two courses of concomitant chemotherapy composed of fluorouracil 800 mg/m ( 2 ) and cisplatin 75 mg/m ( 2 ) .
METHODS	We report the long-term results of the final analysis , after a median follow-up of 93.6 months .
RESULTS	Pretreatment disease was stage I in 19.0 % , IIA in 53.3 % , and IIB in 27.7 % of patients .
RESULTS	For group CRT compared with group S , R0 resection rate was 93.8 % versus 92.1 % ( P = .749 ) , with 3-year overall survival rate of 47.5 % versus 53.0 % ( hazard ratio [ HR ] , 0.99 ; 95 % CI , 0.69 to 1.40 ; P = .94 ) and postoperative mortality rate of 11.1 % versus 3.4 % ( P = .049 ) , respectively .
RESULTS	Because interim analysis of the primary end point revealed an improbability of demonstrating the superiority of either treatment arm ( HR , 1.09 ; 95 % CI , 0.75 to 1.59 ; P = .66 ) , the trial was stopped for anticipated futility .
CONCLUSIONS	Compared with surgery alone , NCRT with cisplatin plus fluorouracil does not improve R0 resection rate or survival but enhances postoperative mortality in patients with stage I or II EC .

###24411556
OBJECTIVE	To examine the long-term safety of oral ospemifene , a non-estrogen tissue-selective estrogen agonist/antagonist , for the treatment of moderate to severe dyspareunia , a symptom of vulvar and vaginal atrophy ( VVA ) due to menopause .
METHODS	This multicenter , long-term , open-label , safety extension study was conducted in women without a uterus aged 40-80 years ( N = 301 ) who received oral ospemifene 60 mg/day for 52 weeks .
METHODS	Participants either continued their 60-mg/day ospemifene dose from the initial 12-week pivotal efficacy study or switched from blinded placebo or ospemifene 30 mg/day to open-label ospemifene 60 mg/day .
METHODS	The 52-week open-label extension period plus initial 12-week treatment period totaled up to 64 weeks of ospemifene exposure .
METHODS	A 4-week posttreatment follow-up ensued ( 68 weeks total ) .
METHODS	Safety assessments included adverse events , laboratory studies , physical and gynecologic examination , vital signs , breast palpation , and mammography .
RESULTS	Most treatment-emergent adverse events ( TEAEs ) during the extension study were mild or moderate in severity .
RESULTS	The most common TEAE related to study drug was hot flushes ( 10 % ; leading to discontinuation for 2 % of patients ) .
RESULTS	One serious TEAE , a non-ST-elevation myocardial infarction in a patient with pre-existing cardiac disease , was considered possibly related to study medication .
RESULTS	One mild breast-related TEAE , considered unrelated to study drug , was ongoing at study completion .
RESULTS	There were no instances of pelvic organ prolapse , incontinence , venous thromboembolism , fractures , breast cancers or death .
RESULTS	No clinically significant adverse changes were observed in other safety parameters .
CONCLUSIONS	Ospemifene is clinically safe and generally well tolerated in postmenopausal patients with dyspareunia , a symptom of VVA .

###25623207
BACKGROUND	Although the need for hand hygiene ( HH ) is generally accepted , studies continue to document inadequate compliance .
BACKGROUND	Medical students are taught about the importance of HH to prevent nosocomial infections , and receive training in the correct procedures for HH .
BACKGROUND	However , personality traits ( social orientation and achievement orientation ) may influence HH compliance .
BACKGROUND	People with high social orientation feel socially responsible and act cooperatively , and people with high achievement orientation are ambitious and competitive .
OBJECTIVE	To evaluate the relationship between HH compliance and personality traits of medical students .
METHODS	The HH compliance of 155 students was observed during objective standardized clinical examinations ( OSCEs ) .
METHODS	Social orientation and achievement orientation were measured using the corresponding scales of the Freiburg Personality Inventory - Revised .
RESULTS	Social orientation did not differ between students with high HH compliance and students with low HH compliance [ F ( 1 ) = 3.87 , P = 0.052 , ( 2 ) = 0.045 ] .
RESULTS	For achievement orientation , a moderate effect was found between low and high HH compliance [ F ( 1 ) = 11.242 , P = 0.001 , ( 2 ) = 0.119 ] , and students with high HH compliance were found to be more achievement orientated than students with low HH compliance .
CONCLUSIONS	Achievement orientation plays a major role during OSCEs , while social orientation is less emphasized .
CONCLUSIONS	To the authors ' knowledge , this is the first study to show that HH compliance is associated with achievement orientation in achievement situations .

###25321162
OBJECTIVE	The objective of this study was to explore the effects of hypotonic and isotonic oral mannitol on intestinal distention and fluorine-18 fluorodeoxyglucose ( ( 18 ) F-FDG ) intake in PET/computed tomography ( CT ) imaging .
METHODS	A total of 124 patients without gastrointestinal disease were evaluated with PET/CT imaging and divided into four groups using a random number table .
METHODS	Group 1 drank plain water , group 2 drank 2.5 % mannitol , group 3 drank 2.5 % mannitol and also received 10mg of scopolamine butylbromide , and group 4 drank 2.5 % mannitol and also received 20mg of scopolamine butylbromide .
METHODS	The patients in each group underwent PET/CT imaging 50min after ( 18 ) F-FDG injection .
METHODS	In these groups , differences such as age , sex , disease distribution , oral liquid amount , and adverse reactions were compared .
METHODS	Gastrointestinal distention and F-FDG intake were analyzed by two experts in nuclear medicine by visual observation .
METHODS	Data were statistically analyzed using a rank-sum test , RC contingency table , one-way analysis of variance , and a paired t-test .
RESULTS	There were no significant differences in blood glucose levels after oral administration of 2.5 % mannitol ( t = 0.62 , P > 0.05 ) .
RESULTS	Gastrointestinal distention of patients in groups 2 , 3 , and 4 was superior to that of patients in group 1 ( P < 0.05 / 6 ) .
RESULTS	In addition to the sigmoid colon and rectum , ( 18 ) F-FDG intake in each part of the gastrointestinal tract in groups 2 , 3 , and 4 was less than that in group 1 ( P < 0.05 / 6 ) .
RESULTS	Patients in group 4 experienced significantly more adverse reactions compared with patients in the other groups ( P < 0.05 ) .
CONCLUSIONS	Oral negative contrast agent and hypotonic bowel preparation decreased the physiological intake of ( 18 ) F-FDG , increased the distention of the gastrointestinal tract , and thus improved the image quality .

###24401765
BACKGROUND	The present study investigated whether prochlorperazine affects vestibulo-ocular reflex ( VOR ) and vestibulo-perceptual function .
METHODS	We studied 12 healthy nave subjects 3 h after a single dose of oral prochlorperazine 5 mg in a randomised , placebo-controlled , double-blind , crossover study in healthy young subjects .
METHODS	Two rotational tests in yaw were used : ( 1 ) a threshold task investigating perceptual motion detection and nystagmic thresholds ( acceleration steps of 0.5 / s ( 2 ) ) and ( 2 ) suprathreshold responses to velocity steps of 90/s in which vestibulo-ocular and vestibuloperceptual time constants of decay , as well as VOR gain , were measured .
RESULTS	Prochlorperazine had no effect upon any measure of nystagmic or perceptual vestibular function compared to placebo .
RESULTS	This lack of effects on vestibular-mediated motion perception suggests that the drug is likely to act more as an anti-emetic than as an antivertiginous agent .

###25454409
BACKGROUND	Craving is viewed as a core feature of substance use disorders and has been shown to predict future drug use , particularly over the short term .
BACKGROUND	Accordingly , craving is often assessed in treatment settings as a marker of risk for subsequent drug use .
BACKGROUND	The identification of the briefest measure that maintains predictive validity is of particular value for both clinical and research settings to minimize assessment burden while maintaining utility for the prediction of use .
METHODS	Data from a multi-site clinical trial of treatment for prescription opioid dependence were examined to evaluate whether a brief , 3-item craving scale administered each week predicted urine-confirmed self report of prescription opioid use in the subsequent week .
METHODS	Logistic regression models examining the association between craving and presence or absence of opioid use in the following week were conducted , controlling for opioid use in the previous week , treatment condition , and lifetime history of heroin use .
RESULTS	Greater craving was associated with a higher odds of prescription opioid use in the following week .
RESULTS	For each one-unit increase on this 10-point scale , the odds of using opioids in the subsequent week was 17 % higher .
RESULTS	In addition to an item assessing urges , items assessing cue-induced craving and perceived likelihood of relapse in an environment where drugs were previously used contributed uniquely to this association .
CONCLUSIONS	A brief measure of prescription opioid craving predicted prescription opioid use among individuals in treatment .
CONCLUSIONS	This measure offers an efficient strategy to inform the assessment of risk for use in this population .

###25433040
OBJECTIVE	Ciclosporin and MTX are used in idiopathic inflammatory myopathies ( DM and PM ) when patients incompletely respond to glucocorticoids .
OBJECTIVE	Their effectiveness is unproved in randomized controlled trials ( RCTs ) .
OBJECTIVE	We evaluated their benefits in a placebo-controlled factorial RCT .
METHODS	A 56-week multicentre factorial-design double-blind placebo-controlled RCT compared steroids alone , MTX ( 15-25 mg weekly ) plus steroids , ciclosporin ( 1-5 mg/kg/day ) plus steroids and all three treatments .
METHODS	It enrolled adults with myositis ( by Bohan and Peter criteria ) with active disease receiving corticosteroids .
RESULTS	A total of 359 patients were screened and 58 randomized .
RESULTS	Of the latter , 37 patients completed 12 months of treatment , 7 were lost to follow-up and 14 discontinued treatment .
RESULTS	Patients completing 12 months of treatment showed significant improvement ( P < 0.001 on paired t-tests ) in manual muscle testing ( 14 % change ) , walking time ( 22 % change ) and function ( 9 % change ) .
RESULTS	Intention to treat and completer analyses indicated that ciclosporin monotherapy , MTX monotherapy and ciclosporin/MTX combination therapy showed no significant treatment effects in comparison with placebo .
CONCLUSIONS	Neither MTX nor ciclosporin ( by themselves or in combination ) improved clinical features in myositis patients who had incompletely responded to glucocorticoids .
BACKGROUND	International Standard Randomized Controlled Trial Number Register ; http://www.controlled-trials.com/; ISRCTN40085050 .

###26231133
OBJECTIVE	To analyze the underlying risk factors in patients with nonarteritic central retinal artery occlusion ( CRAO ) in a well-defined and homogenous group of patients enrolled in the European Assessment Group for Lysis in the Eye ( EAGLE ) study .
METHODS	Analysis of the cardiovascular risk factors in a prospective , randomized clinical trial .
METHODS	Seventy-seven EAGLE patients with nonarteritic CRAO .
METHODS	Analysis of vascular risk factors and underlying diseases detected by questionnaire and standardized physical examination within 1 month after occlusion .
METHODS	The standardized physical examination included carotid Doppler ultrasonography , echocardiography , electrocardiography , blood pressure monitoring , pulse rate , urine analysis , body mass index analysis , and laboratory tests .
RESULTS	Seventy-seven of 84 patients had complete datasets for analysis .
RESULTS	Fifty-two ( 67 % ) patients had cardiovascular risk factors in their medical history , and comprehensive phenotyping identified at least 1 new risk factor in 60 patients ( 78 % ; 95 % confidence interval , 67 % -87 % ) .
RESULTS	Thirty-one ( 40 % ) had carotid artery stenosis of at least 70 % .
RESULTS	Eleven patients experienced a stroke , 5 of those within 4 weeks after the CRAO occurred .
RESULTS	Arterial hypertension was found in 56 ( 73 % ) patients and was newly diagnosed in 12 ( 16 % ) study participants .
RESULTS	Cardiac diseases were also highly prevalent ( 22 % coronary artery disease , 20 % atrial fibrillation , and 17 % valvular heart disease ) .
CONCLUSIONS	Previously undiagnosed vascular risk factors were found in 78 % of all CRAO patients .
CONCLUSIONS	The most meaningful risk factor was ipsilateral carotid artery stenosis .
CONCLUSIONS	A comprehensive and prompt diagnostic work-up is mandatory for all CRAO patients .

###25168524
OBJECTIVE	To evaluate the effectiveness of electrical stimulation of the posterior tibialis nerve in men with neurogenic overactive bladder secondary to ischemic stroke at 45 days and 12 months after treatment .
METHODS	We studied 24 patients older than 18 years , with ischemic stroke that occurred between 6 months and 3 years previously and with no prior urinary symptoms .
METHODS	These patients were randomly allocated to receive electrical stimulation of the posterior tibialis nerve twice weekly for 6 weeks ( treatment group , n = 12 ) or general advice and stretching sessions 1 to 3 times monthly for 6 weeks ( control group , n = 12 ) .
METHODS	Each session lasted 30 minutes in both groups .
METHODS	The primary outcomes were reduction in urinary frequency , reduction in urinary urgency , and overall improvement in voiding diary variables .
RESULTS	Patients in the electrical stimulation group , in relation to baseline and to control group , experienced improvement in urinary symptoms , reducing urinary urgency and frequency , and reported subjective improvement after treatment .
RESULTS	This effect persisted after 12 months of follow-up .
RESULTS	The patients with lesion in right hemisphere , advanced age , and with higher body mass index presented more chance to develop urinary symptoms .
CONCLUSIONS	Electrical stimulation of the posterior tibialis nerve is a safe and effective option for the treatment of poststroke neurogenic overactive bladder in men , reducing urinary frequency and urgency .

###25592008
OBJECTIVE	The aim of this study was to evaluate whether an iron-fortified formula with a concentration of lactoferrin would significantly improve the hematologic indexes and iron status in term infants compared with those same values in infants fed an iron-fortified formula without lactoferrin .
METHODS	In this prospective , multicenter , controlled intervention study , 260 infants ages 4 to 6mo were selected from six maternal and children 's health care hospitals in the area .
METHODS	All infants were divided into two groups with the sequence of outpatient : lactoferrin-fortified formula milk group ( fortified group , FG , containing lactoferrin 38mg/100g milk and iron element 4mg/100g milk ) and no lactoferrin fortified milk ( control group , CG , containing lactoferrin 0mg/100g milk and iron element 4mg/100g milk ) for 3mo .
METHODS	The levels of weight , height , and head circumference and the concentration of hemoglobin ( Hb ) , serum ferritin ( SF ) , and serum transferring receptor ( sTfR ) were measured and sTfR-SF index ( TFR-F index ) , total body iron content ( TBIC ) and low height for age ( HAZ ) , low weight for age ( WAZ ) , and low weight for height ( WHZ ) were computed before and after the intervention , respectively .
RESULTS	In all , 213 ( 115 in FG and 98 in CG ) infants completed the intervention trial and all measurements of biochemical indicators .
RESULTS	There were no significant differences in the average amount of daily intake of formula milk ( 94.39.8 g versus 88.28.7 gfor FG and CG ; P > 0.05 ) and iron element ( 3.80.4 mg versus 3.70.6 mg for FG and CG ; P > 0.05 ) .
RESULTS	The average amount of daily intake of lactoferrin for infants in FG group was 35.83.7 mg .
RESULTS	The levels of weight , WAZ , WHZ , Hb , SF , TFR-F index , and TBIC after intervention of infants in FG were all significantly higher than those of infants in CG weight , 8723245g versus 8558214g ; WAZ , 1.020.31 versus 0.440.18 ; WHZ , 0.980.31 versus 0.410.12 ; Hb , 125.515.4 g/L versus 116.913.1 g/L ; SF , 44.717.2 g/L versus 31.618.4 g/L ; TFR-F index , 1.880.41 versus 1.260.39 ; TBIC , 6.120.78 mg/kg versus 5.260.55 mg/kg for FG and CG ; P < 0.05 ) , but significantly lower ( P < 0.05 ) for the prevalence of anemia ( 4.1 % versus 7.5 % ) , iron deficiency ( 13.9 % versus 24.4 % ) , and iron-deficient anemia ( 1.7 % versus 6.1 % ) .
CONCLUSIONS	When infants who were exclusively breastfed were supplemented with lactoferrin-fortified milk , significant increases in TBIC and iron absorption in the intestine were seen .

###25406858
BACKGROUND	Homecare re-ablement services have been developed by local authorities in England in response to the government agenda for health and social care .
BACKGROUND	These services aim to optimize users ' independence and ability to cope at home , and reduce the need for ongoing health and social care services .
BACKGROUND	However , there is currently limited evidence and guidance regarding the optimum configuration and delivery of re-ablement services .
BACKGROUND	In particular , the impact of occupational therapy input on service user outcomes has been highlighted as a specific research priority .
METHODS	This feasibility randomized controlled trial ( RCT ) will recruit 50 people from one local authority led homecare re-ablement service in England .
METHODS	Those who provide informed consent will be randomized to receive either usual homecare re-ablement ( without routine occupational therapy input ) or usual homecare re-ablement plus an enhanced program targeted at activities of daily living ( ADL ) , delivered by an occupational therapist .
METHODS	The primary aim of this study is to assess the feasibility of conducting a further , powered study .
METHODS	The participant outcomes assessed will be independence in personal and extended ADL , health and social care-related quality of life , number of care support hours , falls , acute and residential admissions and use of health and social care services .
METHODS	These will be assessed at two weeks , three months and six months post-discharge from the re-ablement service .
CONCLUSIONS	To our knowledge , this is the first RCT of occupational therapy in homecare re-ablement services .
CONCLUSIONS	The results of this study will lay the foundations for a further powered study .
CONCLUSIONS	The findings will be relevant to researchers , clinicians , commissioners and users of adult social care services .
BACKGROUND	Current Controlled Trials registration number : ISRCTN21710246 ( registered on 31March 2014 ) .

###24535791
OBJECTIVE	Patients usually suffer significant pain after lumbar laminectomy .
OBJECTIVE	Wound infiltration with local anesthetics is a useful method for postoperative pain control .
OBJECTIVE	Our aim was to compare the efficacies of preemptive wound infiltration with bupivacaine and levobupivacaine .
METHODS	60 patients were randomized three groups as follows : Group L wound infiltration with 20 mL 0.25 % levobupivacaine and 40 mg methylprednisolone just before wound closure ; Group B wound infiltration with 20 mL 0.25 % bupivacaine and 40 mg methylprednisolone before closure ; Group C had this region infiltrated with 20 ml physiological saline .
METHODS	Demographic data , vital signs , postoperative pain scores and morphine usage were recorded .
RESULTS	First analgesic requirement time was significantly shorter in the control group compared to other two groups ( p < 0.001 ) .
RESULTS	Group B had the lowest cumulative morphine consumption at the end of 24 hours within 0-4 , 4-12 and 12-24 hours time intervals and the values were not significant when compared with Group L , however the consumption of both groups was significantly lower compared to the control group ( p < 0.001 ) .
CONCLUSIONS	Our data suggest that preoperative infiltration of the wound site with bupivacaine or levobupivacaine provides similarly effective pain control with reduced opiate dose after unilateral lumbar laminectomy .

###24450538
OBJECTIVE	To examine the impact of night-shift duration ( 9 hours or > 9 hours ) on efficacy and tolerability of armodafinil in patients with shift work disorder ( SWD ) .
METHODS	This was a post hoc analysis of a 6 week , multicenter , randomized , double-blind , placebo-controlled , parallel-group study .
METHODS	Shift workers with diagnosed SWD and late-in-shift sleepiness ( between 4am and 8am , including the commute home ) received armodafinil 150mg or placebo before their night shift .
RESULTS	Proportion of patients with at least minimal improvement in late-in-shift sleepiness , late-in-shift Clinical Global Impressions-Change ( CGI-C ) rating and Karolinska Sleepiness Scale ( KSS ) , as well as overall Global Assessment of Functioning ( GAF ) scale and modified Sheehan Disability Scale ( SDS-M ) , were assessed at baseline and final visit .
RESULTS	Of the 383 patients enrolled , 279 ( 73 % ) worked shifts 9 hours and 104 ( 27 % ) worked shifts > 9 hours .
RESULTS	A greater percentage of patients receiving armodafinil had at least minimal improvement in late-in-shift CGI-C ( 9 hours : 78 % vs 60 % , P = 0.0017 ; > 9 hours : 77 % vs 46 % , P = 0.0020 ) regardless of shift duration .
RESULTS	Armodafinil patients also demonstrated significantly greater improvements in GAF score ( 9 hours : 9.5 vs 5.4 , P < 0.0001 ; > 9 hours : 9.6 vs 4.3 , P = 0.0019 ) and KSS score ( 9 hours : -2.9 vs -1.9 , P = 0.0002 ; > 9 hours : -2.8 vs -1.6 , P = 0.00 28 ) .
RESULTS	Improvement in SDS-M composite score was significantly greater for armodafinil patients working > 9 hours ( -6.8 vs -2.7 , P = 0.0086 ) .
RESULTS	Headache was the most frequent adverse event in all treatment groups .
CONCLUSIONS	Patients receiving armodafinil had significantly greater improvements in late-in-shift clinical condition and in wakefulness and overall global functioning than did placebo-treated patients , regardless of shift duration .
CONCLUSIONS	Prospectively designed , randomized clinical trials that include objective measures of sleepiness are needed to support these findings .

###24524214
BACKGROUND	Cognitive Behaviour Therapy for Insomnia ( CBT-I ) delivered through the Internet is effective as a treatment in reducing insomnia in individuals seeking help for insomnia .
BACKGROUND	CBT-I also lowers levels of depression in this group .
BACKGROUND	However , it is not known if targeting insomnia using CBT-I will lower depressive symptoms , and thus reduce the risk of major depressive episode onset , in those specifically at risk for depression .
BACKGROUND	Therefore , this study aims to examine whether Internet delivery of fully automated self-help CBT-I designed to reduce insomnia will prevent depression .
METHODS	A sample of 1,600 community-dwelling adults ( aged 18-64 ) , who screen positive for both subclinical levels of depressive symptoms and insomnia , will be recruited via various media and randomised to either a 9-week online insomnia treatment programme , Sleep Healthy Using The internet ( SHUTi ) , or an online attention-matched control group ( HealthWatch ) .
METHODS	The primary outcome variable will be depression symptom levels at the 6-month post-intervention on the Patient Heath Questionnaire-9 ( PHQ-9 ) .
METHODS	A secondary outcome will be onset of major depressive episodes assessed at the 6-month post-intervention using ` current ' and ` time from intervention ' criteria from the Mini International Neuropsychiatric Interview .
CONCLUSIONS	This trial is the first randomised controlled trial of an Internet-based insomnia intervention as an indicated preventative programme for depression .
CONCLUSIONS	If effective , online provision of a depression prevention programme will facilitate dissemination .
BACKGROUND	Australian New Zealand Clinical Trials Registry ( ANZCTR ) , Registration number : ACTRN12611000121965 .

###24651230
BACKGROUND	Blood hemoglobin can be monitored continuously and noninvasively with a noninvasive spectrophotometric sensor ( Masimo SpHb ) .
BACKGROUND	The perfusion index ( PI ) of the finger is directly related to the clinical accuracy of SpHb .
BACKGROUND	We evaluated those variables that influence PI without the influences of surgery and anesthesia .
METHODS	Based on our past studies , 12 awake adult volunteers were studied .
METHODS	A SpHb sensor was attached to the same finger of each hand .
METHODS	The temperature of each finger was measured via a skin surface probe .
METHODS	A digital nerve block ( DNB ) was performed with 1 % lidocaine on one finger and 0.25 % bupivacaine on the other finger of the opposite hand .
METHODS	SpHb , PI , and finger temperature were monitored continuously 30 minutes before and 3 to 4 hours after placement of the DNB .
METHODS	A random effects spline regression was used to flexibly model the outcomes before and after the DNB and to compare the effects of lidocaine and bupivacaine .
RESULTS	The DNBs increased the PI for both lidocaine and bupivacaine ( P < 0.0001 ) and finger temperature from both lidocaine ( P < 0.0001 ) and bupivacaine ( P = 0.02 ) .
RESULTS	The duration of action of bupivacaine was markedly longer than that of lidocaine ( P < 0.0001 ) .
RESULTS	Between 45 and 75 minutes after insertion of the DNB , the PI with bupivacaine was substantially higher than that of lidocaine .
RESULTS	The PI was directly related to changes in finger temperature and SpHb .
RESULTS	During this time interval , 11 of the 12 volunteers receiving bupivacaine descriptively had increases in finger temperature ranging from no change to 6.1 C.
RESULTS	In contrast , only 6 of the 12 lidocaine volunteers had increases in finger temperature ranging from no change to 4C .
RESULTS	Changes in PI were directly correlated with SpHb values ( correlation coefficient = 0.7 ) .
CONCLUSIONS	A DNB increases PI and finger temperature .
CONCLUSIONS	These increases lasted 2 to 3 hours longer with bupivacaine than lidocaine .
CONCLUSIONS	The increases in PI were associated with slightly higher SpHb values .
CONCLUSIONS	We conclude that the DNB induces increases in PI and temperature of the finger .
CONCLUSIONS	Because of the close relationship between finger temperature , PI , and SpHb , consistently increasing finger temperature and PI could increase the accuracy of SpHb .

###25560423
OBJECTIVE	The effectiveness of noninvasive positive-pressure ventilation in preventing reintubation due to respiratory failure in children remains uncertain .
OBJECTIVE	A pilot study was designed to evaluate the frequency of extubation failure , develop a randomization approach , and analyze the feasibility of a powered randomized trial to compare noninvasive positive-pressure ventilation and standard oxygen therapy post extubation for preventing reintubation within 48 hours in children with respiratory failure .
METHODS	Prospective pilot study .
METHODS	PICU at a university-affiliated hospital .
METHODS	Children aged between 28 days and 3 years undergoing invasive mechanical ventilation for greater than or equal to 48 hours with respiratory failure after programmed extubation .
METHODS	Patients were prospectively enrolled and randomly assigned into noninvasive positive-pressure ventilation group and inhaled oxygen group after programmed extubation from May 2012 to May 2013 .
RESULTS	Length of stay in PICU and hospital , oxygenation index , blood gas before and after tracheal extubation , failure and reason for tracheal extubation , complications , mechanical ventilation variables before tracheal extubation , arterial blood gas , and respiratory and heart rates before and 1 hour after tracheal extubation were analyzed .
RESULTS	One hundred eight patients were included ( noninvasive positive-pressure ventilation group , n = 55 and inhaled oxygen group , n = 53 ) , with 66 exclusions .
RESULTS	Groups did not significantly differ for gender , age , disease severity , Pediatric Risk of Mortality at admission , tracheal intubation , and mechanical ventilation indications .
RESULTS	There was no statistically significant difference in reintubation rate ( noninvasive positive-pressure ventilation group , 9.1 % ; inhaled oxygen group , 11.3 % ; p > 0.05 ) and length of stay ( days ) in PICU ( noninvasive positive-pressure ventilation group , 3 [ 1-16 ] ; inhaled oxygen group , 2 [ 1-25 ] ; p > 0.05 ) or hospital ( noninvasive positive-pressure ventilation group , 19 [ 7-141 ] ; inhaled oxygen group , 17 [ 8-80 ] ) .
CONCLUSIONS	The study indicates that a larger randomized trial comparing noninvasive positive-pressure ventilation and standard oxygen therapy in children with respiratory failure is feasible , providing a basis for a future trial in this setting .
CONCLUSIONS	No differences were seen between groups .
CONCLUSIONS	The number of excluded patients was high .

###24524874
BACKGROUND	The rate of prophylactic mastectomies ( PM ) is increasing .
BACKGROUND	Patients generally report high levels of health related quality of life and satisfaction after the procedure , whereas body image perception and sexuality may be negatively affected .
BACKGROUND	The aim of the study was to evaluate the interest in physical therapy as a means of improving body image and sexuality in women after PM .
METHODS	Patients undergoing PM at Karolinska University Hospital between 2006 and 2010 were eligible .
METHODS	The following patient-reported outcome measures were used at study baseline and 2 years postoperatively : the body image scale ( BIS ) , the sexual activity questionnaire ( SAQ ) , the short-form health survey ( SF-36 ) , the hospital anxiety and depression scale ( HAD ) , and a study specific `` pain/motion/sensation scale '' .
RESULTS	Out of 125 patients invited to participate in this prospective randomized study , 43 ( 34 % ) consented and were randomized into the intervention ( n = 24 , 56 % ) or control ( n = 19 , 44 % ) groups .
RESULTS	There were no statistically significant between-group differences found with respect to BIS , SAQ , SF-36 , HAD , and `` pain/motion/sensation '' .
RESULTS	Two years postoperatively , more than half of the patients in both groups reported problems like feeling less attractive , less sexually attractive , their body feeling less whole , and being dissatisfied with their body .
RESULTS	A majority marked a decreased sensation in breast area .
CONCLUSIONS	The interest in a physiotherapy intervention was limited among women who had undergone PM .
CONCLUSIONS	The intervention did not show any substantial effects .
CONCLUSIONS	A large proportion of patients reported specific body image related and pain/motion/sensation problems postoperatively .

###24460318
BACKGROUND	Understanding and enhancing change capabilities , including Practice Adaptive Reserve ( PAR ) , of Community Health Centers ( CHCs ) may mitigate cancer-related health disparities .
METHODS	Using stratified random sampling , we recruited 232 staff from seven CHCs serving Asian Pacific Islander communities to complete a self-administered survey .
METHODS	We performed multilevel regression analyses to examine PAR composite scores by CHC , position type , and number of years worked at their clinic .
RESULTS	The mean PAR score was 0.7 ( s.d. 0.14 ) .
RESULTS	Higher scores were associated with a greater perceived likelihood that clinic staff would participate in an evidence-based intervention ( EBI ) .
RESULTS	Constructs such as communication , clinic flow , sensemaking , change valence , and resource availability were positively associated with EBI implementation or trended toward significance .
CONCLUSIONS	PAR scores are positively associated with perceived likelihood of clinic staff participation in cancer screening EBI .
CONCLUSIONS	Future research is needed to determine PAR levels most conducive to implementing change and to developing interventions that enhance Adaptive Reserve .

###25079399
BACKGROUND	Although several plaque indices exist , they rarely assess in detail the plaque adjacent to the gingival margin , an area most important for periodontal health .
BACKGROUND	This study aims to develop a new marginal plaque index ( MPI ) and to assess its validity and treatment sensitivity compared to the internationally accepted Turesky modification of the Quigley and Hein Index ( TQHI ) .
METHODS	Data from two studies with n = 64 and n = 67 participants , respectively , are reported here .
METHODS	Convergence of MPI with TQHI and concurrent and predictive validity with papillary bleeding index were assessed , as was treatment sensitivity to a treatment of proximal hygiene ( study 1 ) or toothbrushing ( study 2 ) , respectively .
RESULTS	Convergent validity with TQHI is very good .
RESULTS	Concurrent and predictive validity parameters of the MPI are similar to the TQHI .
RESULTS	The treatment sensitivity of MPI exceeds TQHI by far .
RESULTS	This results in a reduction by > 70 % of the sample size needed to discover significant treatment effects .
RESULTS	As expected , the largest treatment sensitivity was observed for proximal MPI measures in study 1 , whereas study 2 showed largest effects for cervical measures .
CONCLUSIONS	MPI appears to be a valid plaque-scoring system that assesses plaque at the gingival margin .
CONCLUSIONS	It responds with high sensitivity to treatments aimed at plaque reduction at the gingival margin .
CONCLUSIONS	Its treatment sensitivity and capacity to differentiate between proximal and cervical plaque make it a promising tool for periodontal research .

###25199912
BACKGROUND	We compared the effects of two uniquely different lower extremity power training interventions on changes in muscle power , physical performance , neuromuscular activation , and muscle cross sectional area in mobility-limited older adults .
METHODS	Fifty-two subjects ( 785 years , short physical performance battery score : 8.11 ) were randomized to either 16 weeks of progressive high velocity resistance training performed at low external resistance ( 40 % of the 1-repetition maximum [ 1-RM ] [ LO ] ) or high external resistance ( 70 % of 1RM [ HI ] ) .
METHODS	Both groups completed three sets of leg and knee extension exercises at maximum voluntary velocity , two times per week .
METHODS	Neuromuscular activation was assessed using surface electromyography and muscle cross sectional area ( CSA ) was measured using computed tomography .
RESULTS	At 16 weeks , LO and HI exhibited significant and similar within-group increases of leg extensor peak power ( ~ 34 % vs ~ 42 % ) , strength ( ~ 13 % vs ~ 19 % ) , and SPPB score ( 1.40.3 vs 1.80.3 units ) , respectively ( all P < .03 ) .
RESULTS	Improvements in neuromuscular activation occurred in LO ( P = .03 ) while small gains in mid-thigh muscle CSA were detected in LO ( 1.6 % , P = .35 ) and HI ( 2.1 % , P = .17 ) .
RESULTS	No significant between-group differences were evident for any measured parameters ( all P > .25 ) .
CONCLUSIONS	High velocity resistance training with low external resistance yields similar improvements in muscle power and physical performance compared to training with high external resistance in mobility-limited elders .
CONCLUSIONS	These findings may have important implications for optimizing exercise interventions for older adults with mobility limitations .

###24365174
BACKGROUND	Low levels of cardiorespiratory fitness are associated with high risk of non-communicable diseases and all-cause mortality .
BACKGROUND	Physical activity level is the primary determinant of cardiorespiratory fitness in adults .
BACKGROUND	However , knowledge on how to motivate people to engage in physical activity and maintain an active lifestyle is lacking .
BACKGROUND	This study aims to investigate whether a motivational , individual , and locally anchored exercise intervention , in primary care , can improve cardiorespiratory fitness in 30 to 49 year olds with a low or very low cardiorespiratory fitness .
METHODS	Two-armed randomised controlled trial with 6 and 12 months follow-up .
METHODS	The primary outcome is cardiorespiratory fitness estimated via a maximal incremental exercise test .
METHODS	Secondary outcomes include physical activity level and sedentary behavior ( objectively measured ) , self-reported physical activity , biochemical parameters ( HbA1C , HDL - and LDL-cholesterol , and triglyceride ) , anthropometric parameters and health-related quality of life .
METHODS	A total of 236 participants with low levels of cardiorespiratory fitness classified at a local health check programme will be randomised .
METHODS	The intervention consists of four motivational interviews , a six months membership to a sport club , and a global positioning watch to upload training activity to Endomondo.com .
METHODS	The comparison group will receive standard care : a one hour motivational interview followed by another interview if requested .
METHODS	Effects will be estimated by evaluating the differences in mean changes in cardiorespiratory fitness between the two groups .
CONCLUSIONS	In new and innovative ways the focus of this study will be to improve cardiorespiratory fitness among a 30-49 year-old at-risk group using social media , Global Positioning System-technology , on-going personal support and individually tailored physical activity .
BACKGROUND	ClinicalTrials.gov ( no.NCT01801956 ) .

###24247275
OBJECTIVE	Adherence to cardioprotective medication regimens in the year after hospitalization for acute coronary syndrome ( ACS ) is poor .
OBJECTIVE	To test a multifaceted intervention to improve adherence to cardiac medications .
METHODS	In this randomized clinical trial , 253 patients from 4 Department of Veterans Affairs medical centers located in Denver ( Colorado ) , Seattle ( Washington ) ; Durham ( North Carolina ) , and Little Rock ( Arkansas ) admitted with ACS were randomized to the multifaceted intervention ( INT ) or usual care ( UC ) prior to discharge .
METHODS	The INT lasted for 1 year following discharge and comprised ( 1 ) pharmacist-led medication reconciliation and tailoring ; ( 2 ) patient education ; ( 3 ) collaborative care between pharmacist and a patient 's primary care clinician and/or cardiologist ; and ( 4 ) 2 types of voice messaging ( educational and medication refill reminder calls ) .
METHODS	The primary outcome of interest was proportion of patients adherent to medication regimens based on a mean proportion of days covered ( PDC ) greater than 0.80 in the year after hospital discharge using pharmacy refill data for 4 cardioprotective medications ( clopidogrel , - blockers , 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors [ statins ] , and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers [ ACEI/ARB ] ) .
METHODS	Secondary outcomes included achievement of blood pressure ( BP ) and low-density lipoprotein cholesterol ( LDL-C ) level targets .
METHODS	RESULTS Of 253 patients , 241 ( 95.3 % ) completed the study ( 122 in INT and 119 in UC ) .
METHODS	In the INT group , 89.3 % of patients were adherent compared with 73.9 % in the UC group ( P = .003 ) .
METHODS	Mean PDC was higher in the INT group ( 0.94 vs 0.87 ; P < .001 ) .
METHODS	A greater proportion of intervention patients were adherent to clopidogrel ( 86.8 % vs 70.7 % ; P = .03 ) , statins ( 93.2 % vs 71.3 % ; P < .001 ) , and ACEI/ARB ( 93.1 % vs 81.7 % ; P = .03 ) but not - blockers ( 88.1 % vs 84.8 % ; P = .59 ) .
METHODS	There were no statistically significant differences in the proportion of patients who achieved BP and LDL-C level goals .
CONCLUSIONS	A multifaceted intervention comprising pharmacist-led medication reconciliation and tailoring , patient education , collaborative care between pharmacist and patients ' primary care clinician and/or cardiologist , and voice messaging increased adherence to medication regimens in the year after ACS hospital discharge without improving BP and LDL-C levels .
CONCLUSIONS	Understanding the impact of such improvement in adherence on clinical outcomes is needed prior to broader dissemination of the program .
BACKGROUND	clinicaltrials.gov Identifier : NCT00903032 .

###25323621
BACKGROUND	The Quality of Life-Bronchiectasis ( QOL-B ) , a self-administered , patient-reported outcome measure assessing symptoms , functioning and health-related quality of life for patients with non-cystic fibrosis ( CF ) bronchiectasis , contains 37 items on 8 scales ( Respiratory Symptoms , Physical , Role , Emotional and Social Functioning , Vitality , Health Perceptions and Treatment Burden ) .
METHODS	Psychometric analyses of QOL-B V. 3.0 used data from two double-blind , multicentre , randomised , placebo-controlled , phase III trials of aztreonam for inhalation solution ( AZLI ) in 542 patients with non-CF bronchiectasis and Gram-negative endobronchial infection .
RESULTS	Excellent internal consistency ( Cronbach 's 0.70 ) and 2-week test-retest reliability ( intraclass correlation coefficients 0.72 ) were demonstrated for each scale .
RESULTS	Convergent validity with 6 min walk test was observed for Physical and Role Functioning scores .
RESULTS	No floor or ceiling effects ( baseline scores of 0 or 100 ) were found for the Respiratory Symptoms scale ( primary endpoint of trials ) .
RESULTS	Baseline Respiratory Symptoms scores discriminated between patients based on baseline FEV % predicted in only one trial .
RESULTS	The minimal important difference score for the Respiratory Symptoms scale was 8.0 points .
RESULTS	AZLI did not show efficacy in the two phase III trials .
RESULTS	QOL-B responsivity to treatment was assessed by examining changes from baseline QOL-B scores at study visits at which protocol-defined pulmonary exacerbations were reported .
RESULTS	Mean Respiratory Symptoms scores decreased 14.0 and 14.2 points from baseline for placebo-treated and AZLI-treated patients with exacerbations , indicating that worsening respiratory symptoms were reflected in clinically meaningful changes in QOL-B scores .
CONCLUSIONS	Previously established content validity , reliability and responsivity of the QOL-B are confirmed by this final validation study .
CONCLUSIONS	The QOL-B is available for use in clinical trials and routine clinical practice .

###24661312
OBJECTIVE	To estimate the short-term effectiveness , feasibility and acceptability of a smoking cessation intervention ( the iQuit system ) that consists of tailored printed and Short Message Service ( SMS ) text message self-help delivered as an adjunct to cessation support in primary care to inform the design of a definitive trial .
METHODS	A stratified two parallel-group randomized controlled trial comparing usual care ( control ) with usual care plus the iQuit system ( intervention ) , delivered by primary care nurses/healthcare assistants who were blinded to the allocation sequence .
METHODS	Thirty-two general practice ( GP ) surgeries in England , UK .
METHODS	A total of 602 smokers initiating smoking cessation support from their local GP surgery were randomized ( control n = 303 , intervention n = 299 ) .
METHODS	Primary outcome was self-reported 2-week point prevalence abstinence at 8 weeks follow-up .
METHODS	Secondary smoking outcomes and feasibility and acceptability measures were collected at 4 weeks after quit date , 8 weeks and 6 months follow-up .
RESULTS	There were no significant between-group differences in the primary outcome [ control 40.3 % , iQuit 45.2 % ; odds ratio ( OR ) = 1.22 , 95 % confidence interval ( CI ) = 0.88-1 .69 ] or in secondary short-term smoking outcomes .
RESULTS	Six-month prolonged abstinence was significantly higher in the iQuit arm ( control 8.9 % , iQuit 15.1 % ; OR = 1.81 , 95 % CI = 1.09-3 .01 ) .
RESULTS	iQuit support took on average 7.7 minutes ( standard deviation = 4.0 ) to deliver and 18.9 % ( 95 % CI = 14.8-23 .7 % ) of intervention participants discontinued the text message support during the programme .
CONCLUSIONS	Tailored printed and text message self-help delivered alongside routine smoking cessation support in primary care does not significantly increase short-term abstinence , but may increase long-term abstinence and demonstrated feasibility and acceptability compared with routine cessation support alone .

###24751432
OBJECTIVE	Compare HIV injecting and sex risk in patients being treated with methadone ( MET ) or buprenorphine-naloxone ( BUP ) .
METHODS	Secondary analysis from a study of liver enzyme changes in patients randomized to MET or BUP who completed 24 weeks of treatment and had 4 or more blood draws .
METHODS	The initial 1:1 randomization was changed to 2:1 ( BUP : MET ) after 18 months due to higher dropout in BUP .
METHODS	The Risk Behavior Survey measured HIV risk before 30 days at baseline and weeks 12 and 24 .
RESULTS	Among 529 patients randomized to MET , 391 ( 74 % ) were completers ; among 740 randomized to BUP , 340 ( 46 % ) were completers ; 700 completed the Risk Behavior Survey .
RESULTS	There were significant reductions in injecting risk ( P < 0.0008 ) with no differences between groups in mean number of times reported injecting heroin , speedball , other opiates , and number of injections ; or percent who shared needles ; did not clean shared needles with bleach ; shared cookers ; or engaged in front/back loading of syringes .
RESULTS	The percent having multiple sex partners decreased equally in both groups ( P < 0.03 ) .
RESULTS	For males on BUP , the sex risk composite increased ; for males on MET , the sex risk decreased resulting in significant group differences over time ( P < 0.03 ) .
RESULTS	For females , there was a significant reduction in sex risk ( P < 0.02 ) with no group differences .
CONCLUSIONS	Among MET and BUP patients who remained in treatment , HIV injecting risk was equally and markedly reduced ; however , MET retained more patients .
CONCLUSIONS	Sex risk was equally and significantly reduced among females in both treatment conditions , but it increased for males on BUP and decreased for males on MET .

###24732316
OBJECTIVE	To explore the association of a functional germline variant in the 3 ' - UTR of KRAS with endometrial cancer risk , as well as the association of microRNA ( miRNA ) signatures and the KRAS-variant with clinical characteristics and survival outcomes in two prospective RTOG endometrial cancer trials .
METHODS	The association of the KRAS-variant with endometrial cancer risk was evaluated by case-control analysis of 467 women with type 1 or 2 endometrial cancer and 582 age-matched controls .
METHODS	miRNA and DNA were isolated for expression profiling and genotyping from tumor specimens of 46 women with type 1 endometrial cancer enrolled in RTOG trials 9708 and 9905 .
METHODS	miRNA expression levels and KRAS-variant genotype were correlated with patient and tumor characteristics , and survival outcomes were evaluated by variant allele type .
RESULTS	The KRAS-variant was not significantly associated with overall endometrial cancer risk ( 14 % controls and 17 % type 1 cancers ) , although was enriched in type 2 endometrial cancers ( 24 % , p = 0.2 ) .
RESULTS	In the combined analysis of RTOG 9708/9905 , miRNA expression differed by age , presence of lymphovascular invasion and KRAS-variant status .
RESULTS	Overall survival rates at 3 years for patients with the variant and wild-type alleles were 100 % and 77 % ( HR 0.3 , p = 0.24 ) , respectively , favoring the variant .
CONCLUSIONS	The KRAS-variant may be a genetic marker of risk for type 2 endometrial cancers .
CONCLUSIONS	In addition , tumor miRNA expression appears to be associated with patient age , lymphovascular invasion and the KRAS-variant , supporting the hypothesis that altered tumor biology can be measured by miRNA expression , and that the KRAS-variant likely impacts endometrial tumor biology .

###24706489
BACKGROUND	Thrombocytopenia in patients with myelodysplastic syndrome ( MDS ) is associated with shortened survival and an increased risk of evolution to acute myeloid leukemia ( AML ) .
BACKGROUND	In this study , the authors evaluated the efficacy of romiplostim in patients who had thrombocytopenia with low-risk/intermediate -1 - risk MDS .
METHODS	Patients who had thrombocytopenia with low-risk/intermediate -1 - risk MDS ( N = 250 ) were randomized 2:1 to receive romiplostim or placebo weekly for 58 weeks .
RESULTS	The primary endpoint - the number of clinically significant bleeding events ( CSBEs ) per patient-had a hazard ratio for romiplostim : placebo of 0.83 ( 95 % confidence interval , 0.66-1 .05 ; P = .13 ) .
RESULTS	CSBEs were reduced significantly in the romiplostim group for patients who had baseline platelet counts 2010 ( 9 ) / L ( P < .0001 ) .
RESULTS	For patients who had baseline platelet counts < 2010 ( 9 ) / L , there was no difference in the number of CSBEs , but the platelet transfusion rates were higher in the placebo group ( P < .0001 ) , which may have affected the overall CSBE results in this group with severe thrombocytopenia .
RESULTS	The incidence of bleeding events was reduced significantly in the romiplostim group ( relative risk , 0.92 ) , as were protocol-defined platelet transfusions ( relative risk , 0.77 ) .
RESULTS	Platelet response rates according to 2006 International Working Group criteria were higher for the group that received romiplostim ( odds ratio , 15.6 ) .
RESULTS	On the basis of interim data , an independent data monitoring committee advised halting study drug because of concerns regarding excess blasts and AML rates with romiplostim ( interim hazard ratio , 2.51 ) .
RESULTS	At 58 weeks , the AML rates were 6 % in the romiplostim group and 4.9 % in the placebo group ( hazard ratio , 1.20 ; 95 % confidence interval , 0.38-3 .84 ) , and the overall survival rates were similar .
CONCLUSIONS	Romiplostim treatment in patients with low-risk/intermediate -1 - risk MDS increased platelet counts and decreased the number of bleeding events and platelet transfusions .
CONCLUSIONS	Although study drug was discontinued because of an initial concern of AML risk , survival and AML rates were similar with romiplostim and placebo .

###25027640
OBJECTIVE	Transcranial direct current stimulation ( tDCS ) has demonstrated efficacy for reducing neuropathic pain , but the respective mechanisms remain largely unknown .
OBJECTIVE	The current study tested the hypothesis that pain reduction with tDCS is associated with an increase in the peak frequency spectrum density in the theta-alpha range .
METHODS	Twenty patients with spinal cord injury and bilateral neuropathic pain received single sessions of both sham and anodal tDCS ( 2 mA ) over the left primary motor area ( M1 ) for 20 min .
METHODS	Treatment order was randomly assigned .
METHODS	Pre - to post-procedure changes in pain intensity and peak frequency of electroencephalogram spectral analysis were compared between treatment conditions .
RESULTS	The active treatment condition ( anodal tDCS over M1 ) but not sham treatment resulted in significant decreases in pain intensity .
RESULTS	In addition , consistent with the study hypothesis , peak theta-alpha frequency ( PTAF ) assessed from an electrode placed over the site of stimulation increased more from pre - to post-session among participants in the active tDCS condition , relative to those in the sham tDCS condition .
RESULTS	Moreover , we found a significant association between a decrease in pain intensity and an increase in PTAF at the stimulation site .
CONCLUSIONS	The findings are consistent with the possibility that anodal tDCS over the left M1 may be effective , at least in part , because it results in an increase in M1 cortical excitability , perhaps due to a pain inhibitory effect of motor cortex stimulation that may influence the descending pain modulation system .
CONCLUSIONS	Future research is needed to determine if there is a causal association between increased left anterior activity and pain reduction .
CONCLUSIONS	The results provide new findings regarding the effects of tDCS on neuropathic pain and brain oscillation changes .

###24998242
BACKGROUND	Cerebral palsy ( CP ) is the most common motor disability in childhood ( 2 to 3 per 1000 live births ) , and is frequently accompanied by cognitive impairments and behavioural problems .
BACKGROUND	Children with CP are at increased risk of attention deficit disorder with or without hyperactivity ( Attention Deficit Disorder ( ADD ) / Attention Deficit Hyperactivity Disorder ( ADHD ) ) including working memory deficits .
BACKGROUND	The primary aim of this study is to evaluate if cognitive training may improve working memory in children with CP .
METHODS	The study is an investigator-blinded , randomized controlled trial with a stepped-wedge design that will include 115 schoolchildren with CP .
METHODS	Eligible for participation are children with CP , aged 7 to 15years , who are able to follow instructions and handle a computer mouse .
METHODS	Exclusion criteria are the presence of photosensitive epilepsy , Gross Motor Function Classification System ( GMFCS ) level V ( most severe CP ) ( Phys Ther 80 : 974-985 , 2000 ) and severe visual or hearing impairments .
METHODS	Following assessment of eligibility and baseline cognitive assessment the participants will be randomized to either cognitive working memory training or treatment-as-usual ( ` control group ' ) .
METHODS	The intervention is a computer-based working memory training program consisting of 25 daily sessions to be performed over a 5 to 6-week period at home .
METHODS	A neuropsychological assessment will be performed before and 4 to 6weeks after completed training .
METHODS	When the latter assessment has been completed in the intervention group , the ` control group ' will start on the same training program .
METHODS	Both groups will meet for a final neuropsychological assessment six months after completed training by an examiner unaware of group adherence .
CONCLUSIONS	There is limited evidence for the effect of most interventions in children with CP , and evidence is completely lacking for interventions aiming to improve deficits in cognition , learning and behaviour .
CONCLUSIONS	The proposed multicenter study , will bring forth comprehensive information about cognitive , neuropsychological , and daily-life functioning in children with CP aged between 7 and 15years .
CONCLUSIONS	In addition , the study will be the first to evaluate the effects of an intervention method to improve working memory in children with CP .
CONCLUSIONS	If successful , computer-based working memory training may represent an efficient and cost-effective intervention for this group of children .
BACKGROUND	ClinicalTrials.gov Identifier : NCT02119364 .

###24361229
BACKGROUND	The prognostic significance of response to induction therapy for rhabdomyosarcoma ( RMS ) by anatomic imaging [ computerised tomographic ( CT ) or magnetic resonance imaging ( MRI ) scan ] is controversial .
BACKGROUND	We previously reported no relationship between early response and failure-free survival ( FFS ) on Intergroup Rhabdomyosarcoma Study ( IRS ) - IV .
BACKGROUND	We repeated the same analysis using a more recent clinical trial as an independent cohort of patients with non-metastatic , initially unresected RMS .
METHODS	A total of 338 patients enrolled in Children 's Oncology Group ( COG ) study D9803 met the inclusion criteria for this analysis : ( 1 ) non-metastatic , initially unresected ( Group III ) ; ( 2 ) embryonal ( ERMS ) or alveolar ( ARMS ) histology ; ( 3 ) documented protocol week 12 response to induction chemotherapy ( excluding progressive disease ) based on anatomic imaging ( CT/MRI ) and ( 4 ) documented protocol therapy beyond week 12 .
METHODS	Response at week 12 was determined by the treating institution as complete response ( CR ) , partial response ( PR ) or no response ( NR ) .
METHODS	FFS was estimated using the Kaplan-Meier method and comparisons between patient subsets were made using the log-rank test .
RESULTS	Overall objective response rate ( CR+PR ) at week 12 of therapy was 85 % and was similar between ERMS and ARMS .
RESULTS	FFS was similar among all patients with CR , PR or NR ( p = 0.49 ) .
RESULTS	Restricting the analysis to either ERMS or ARMS , there was no difference in FFS by response within either histology subset ( p = 0.89 and p = 0.08 , respectively ) .
CONCLUSIONS	These findings provide additional evidence that anatomic imaging to assess early response to therapy among patients with RMS does not predict outcome and has questionable use in tailoring subsequent therapy .

###24296479
METHODS	Multicenter randomized controlled trial .
OBJECTIVE	To evaluate the effect of recombinant human bone morphogenetic protein ( rhBMP-2 ) on radiographical fusion rate and clinical outcome for surgical lumbar arthrodesis compared with iliac crest autograft .
BACKGROUND	In many types of spinal surgery , radiographical fusion is a primary outcome equally important to clinical improvement , ensuring long-term stability and axial support .
BACKGROUND	Biologic induction of bone growth has become a commonly used adjunct in obtaining this objective .
BACKGROUND	We undertook this study to objectify the efficacy of rhBMP-2 compared with traditional iliac crest autograft in instrumented posterolateral lumbar fusion .
METHODS	Patients undergoing 1 - or 2-level instrumented posterolateral lumbar fusion were randomized to receive either autograft or rhBMP-2 for their fusion construct .
METHODS	Clinical and radiographical outcome measures were followed for 2 to 4 years postoperatively .
RESULTS	One hundred ninety seven patients were successfully randomized among the 8 participating institutions .
RESULTS	Adverse events attributable to the study drug were not significantly different compared with controls .
RESULTS	However , the control group experienced significantly more graft-site complications as might be expected .
RESULTS	36-Item Short Form Health Survey , Oswestry Disability Index , and leg/back pain scores were comparable between the 2 groups .
RESULTS	After 4 years of follow-up , radiographical fusion rates remained significantly higher in patients treated with rhBMP-2 ( 94 % ) than those who received autograft ( 69 % ) ( P = 0.007 ) .
CONCLUSIONS	The use of rhBMP-2 for instrumented posterolateral lumbar surgery significantly improves the chances of radiographical fusion compared with the use of autograft .
CONCLUSIONS	However , there is no associated improvement in clinical outcome within a 4-year follow-up period .
CONCLUSIONS	These results suggest that use of rhBMP-2 should be considered in cases where lumbar arthrodesis is of primary concern .

###24480729
BACKGROUND	Informed and engaged parents and healthful home environments are essential for the health of youth .
BACKGROUND	Although research has shown health benefits associated with family meals , to date , no randomized controlled trial ( RCT ) has been developed to examine the impact of a family meals intervention on behavioral and health outcomes .
METHODS	The Healthy Home Offerings via the Mealtime Environment ( HOME ) Plus study is a two-arm ( intervention versus attention-only control ) RCT being conducted in Minneapolis/St .
METHODS	Paul .
METHODS	Built on previous pilot research , HOME Plus aims to increase the frequency and healthfulness of family meals and snacks and reduce children 's sedentary behavior , particularly screen time , to promote healthier eating and activity behaviors and prevent obesity .
METHODS	HOME Plus is delivered to families in community settings .
METHODS	The program includes 10 monthly sessions focused on nutrition and activity education , meal planning and preparation skill development .
METHODS	In addition , five motivational goal-setting phone calls are conducted with parents .
METHODS	The primary outcome measure is age - and gender-adjusted child BMI-z score at post-intervention by treatment group .
METHODS	Secondary household-level outcomes include family meal frequency , home availability of healthful foods ( fruits/vegetables ) and unhealthful foods ( high-fat/sugary snacks ) and beverages ( sugar-sweetened beverages ) , and the quality of foods served at meals and snacks .
METHODS	Secondary child outcomes include dietary intake of corresponding foods and beverages and screen time .
CONCLUSIONS	The HOME Plus RCT actively engages whole families of 8-12 year old children to promote healthier eating and activity behaviors and prevent obesity through promotion of family meals and snacks and limited media use .

###24571917
OBJECTIVE	To determine the effect of active recovery ( AR ) , passive rest ( PR ) , and cold-water immersion ( CWI ) after 90 min of intensive cycling on a subsequent 12-min time trial ( TT2 ) and the applied pacing strategy in TT2 .
METHODS	After a maximal test and familiarization trial , 9 trained male subjects ( age 22 3 y , VO2max 62.1 5.3 mL min-1 kg-1 ) performed 3 experimental trials in the heat ( 30C ) .
METHODS	Each trial consisted of 2 exercise tasks separated by 1 h.
METHODS	The first was a 60-min constant-load trial at 55 % of the maximal power output followed by a 30-min time trial ( TT1 ) .
METHODS	The second comprised a 12-min simulated time trial ( TT2 ) .
METHODS	After TT1 , AR , PR , or CWI was applied for 15 min .
RESULTS	No significant TT2 performance differences were observed , but a 1-sample t test ( within each condition ) revealed different pacing strategies during TT2 .
RESULTS	CWI resulted in an even pacing strategy , while AR and PR resulted in a gradual decline of power output after the onset of TT2 ( P .046 ) .
RESULTS	During recovery , AR and CWI showed a trend toward faster blood lactate ( [ BLa ] ) removal , but during TT2 significantly higher [ BLa ] was only observed after CWI compared with PR ( P = .011 ) .
CONCLUSIONS	The pacing strategy during subsequent cycling performance in the heat is influenced by the application of different postexercise recovery interventions .
CONCLUSIONS	Although power was not significantly altered between groups , CWI enabled a differently shaped power profile , likely due to decreased thermal strain .

###25528153
BACKGROUND	Longitudinal assessment of bone marrow lesions ( BMLs ) in knee osteoarthritis ( KOA ) by MRI is usually performed using semi-quantitative grading methods .
BACKGROUND	Quantitative segmentation methods may be more sensitive to detect change over time .
BACKGROUND	The purpose of this study was to evaluate and compare the validity and sensitivity to detect changes of two quantitative MR segmentation methods for measuring BMLs in KOA , one computer assisted ( CAS ) and one manual ( MS ) method .
METHODS	Twenty-two patients with KOA confined to the medial femoro-tibial compartment obtained MRI at baseline and follow-up ( median 334 days in between ) .
METHODS	STIR , T1 and fat saturated T1 post-contrast sequences were obtained using a 1.5 T system .
METHODS	The 44 sagittal STIR sequences were assessed independently by two readers for quantification of BML .
METHODS	The signal intensities ( SIs ) of the normal bone marrow in the lateral femoral condyles and tibial plateaus were used as threshold values .
METHODS	The volume of bone marrow with SIs exceeding the threshold values ( BML ) was measured in the medial femoral condyle and tibial plateau and related to the total volume of the condyles/plateaus .
METHODS	The 95 % limits of agreement at baseline were used to determine the sensitivity to change .
RESULTS	The mean threshold values of CAS and MS were almost identical but the absolute and relative BML volumes differed being 1319 mm3/10 % and 1828 mm3/15 % in the femur and 941 mm3/7 % and 2097 mm3/18 % in the tibia using CAS and MS , respectively .
RESULTS	The BML volumes obtained by CAS and MS were significantly correlated but the tissue changes measured were different .
RESULTS	The volume of voxels exceeding the threshold values was measured by CAS whereas MS included intervening voxels with normal SI.The 95 % limits of agreement were narrower by CAS than by MS ; a significant change of relative BML by CAS was outside the limits of -2.0 % -4.7 % whereas the limits by MS were -6.9 % -8.2 % .
RESULTS	The BML changed significantly in 13 knees using CAS and in 10 knees by MS.
CONCLUSIONS	CAS was a reliable method for measuring BML and more sensitive to detect changes over time than MS. The BML volumes measured by the two methods differed but were significantly correlated .

###24293756
OBJECTIVE	Investigate the hypnotic effects of repeated doses of neurokinin-1 receptor antagonist , vestipitant , in primary insomnia .
METHODS	Randomized , double-blind , placebo-controlled 28-day parallel-group study .
METHODS	Eleven sleep centers in Germany .
METHODS	One hundred sixty-one patients with primary insomnia .
METHODS	Patients received vestipitant ( 15 mg ) or placebo for 28 days ; 2-night polysomnographic assessment occurred on nights 1/2 and 27/28 .
RESULTS	Wake after sleep onset ( WASO ) was improved on nights 1/2 and 27/28 ( ratio , vestipitant versus placebo [ 95 % confidence interval ] : 0.76 [ 0.65 , 0.90 ] , P = 0.001 and 0.79 [ 0.65 , 0.96 ] , P = 0.02 , respectively ) , demonstrating maintenance of the effect following repeated dosing .
RESULTS	Latency to persistent sleep was shorter with vestipitant on nights 1/2 ( P = 0.0006 versus placebo ) , but not on nights 27/28 .
RESULTS	Total sleep time ( TST ) improved with vestipitant ( nights 1/2 : P < 0.0001 , nights 27/28 : P = 0.02 versus placebo ) .
RESULTS	Next-day cognitive function tests demonstrated no residual effects of vestipitant ( P > 0.05 versus placebo ) .
RESULTS	Adverse events ( AEs ) occurred in 25 % of vestipitant patients versus 22 % for placebo .
RESULTS	Headache was the most common AE ( 8 % of vestipitant patients versus 9 % for placebo ) .
CONCLUSIONS	Vestipitant improved sleep maintenance in patients with primary insomnia , with no associated next-day cognitive impairment .
CONCLUSIONS	The effects on wake after sleep onset and total sleep time were maintained following repeated dosing .

###24491078
OBJECTIVE	There are effective treatments of trichotillomania ( TTM ) , but access to expert providers is limited .
OBJECTIVE	This study tested a stepped care model aimed at improving access .
METHODS	Participants were 60 ( 95 % women , 75 % Caucasian , 2 % Hispanic ) adults ( M = 33.18 years ) with TTM .
METHODS	They were randomly assigned to immediate versus waitlist ( WL ) conditions for Step 1 ( 10 weeks of web-based self-help via StopPulling.com ) .
METHODS	After Step 1 , participants chose whether to engage in Step 2 ( 8 sessions of in-person habit reversal training [ HRT ] ) .
RESULTS	In Step 1 , the immediate condition had a small ( d = .21 ) but significant advantage , relative to WL , in reducing TTM symptom ratings by interviewers ( masked to experimental condition but not to assessment point ) ; there were no differences in self-reported TTM symptoms , alopecia , functional impairment , or quality of life .
RESULTS	Step 1 was more effective for those who used the site more often .
RESULTS	Stepped care was highly acceptable : Motivation did not decrease during Step 1 ; treatment satisfaction was high , and 76 % enrolled in Step 2 .
RESULTS	More symptomatic patients self-selected into HRT , and on average they improved significantly .
RESULTS	Over one third ( 36 % ) made clinically significant improvement in self-reported TTM symptoms .
RESULTS	Considering the entire stepped care program , participants significantly reduced symptoms , alopecia , and impairment , and increased quality of life .
RESULTS	For quality of life and symptom severity , there was some relapse by 3-month follow-up .
CONCLUSIONS	Stepped care is acceptable , and HRT was associated with improvement .
CONCLUSIONS	Further work is needed to determine which patients with TTM can benefit from self-help and how to reduce relapse .

###24339273
OBJECTIVE	Exercise programs targeting muscle strength and balance can reduce falls .
OBJECTIVE	The study aimed to compare the Otago Exercise Program ( OEP ) , originally designed as supervised home training ( HT ) , with the same programme performed as GT , on functional balance and muscle strength , mobility , fall efficacy and self-reported health .
METHODS	A single-blind randomized controlled trial with assessments at baseline ( T1 ) , following the 12-week intervention ( T2 ) , and 3 months following intervention ( T3 ) , was performed .
METHODS	125 people , mean age 82.5 ( SD = 5.7 ) years , 73 % women , referred to a Falls Outpatient Clinic , participated .
METHODS	74 % had fallen , and 37 % had a fall-related hospital stay during the previous year .
METHODS	OEP supervised by physiotherapists was performed as GT twice weekly or as HT three times a week , for 12 weeks .
METHODS	Total exercise time was comparable between groups .
METHODS	The primary outcome was the Berg Balance Scale assessed at T2 .
RESULTS	From T1-T2 , Berg Balance Scale improved significantly more in the GT group than in the HT group ( mean group difference in change of 3.2 points , 95 % CI = 0.7-5 .8 , p = 0.014 ) .
RESULTS	Of the secondary outcomes , the 30-second sit-to-stand test ( p = 0.004 ) , and physical health measured by the Short Form-36 ( p = 0.004 ) , improved significantly more for the GT group .
RESULTS	Change in mobility measured by the Timed Up and Go test , mental health by the Short Form-36 , and fall efficacy by the Fall Efficacy Scale International did not differ between groups .
RESULTS	The 30-second sit-to-stand test and the Timed Up and Go , but not the Berg Balance Scale , was still better in the GT group at T3 .
CONCLUSIONS	In fall-prone home-dwelling older people , the OEP performed as GT is more effective for improving functional balance , muscle strength and physical health , but not fall efficacy and mental health than when performed as HT .
CONCLUSIONS	The OEP provided as GT should be considered in this population .

###24335723
METHODS	This was a prospective , randomized controlled clinical study .
OBJECTIVE	To determine the efficacy of absorbable gelatin sponge in reducing blood loss , as well as shortening the length of hospital stay in patients undergoing multilevel posterior lumbar spinal surgery .
BACKGROUND	Absorbable gelatin sponge is reported to decrease postoperative drain output and the length of hospital stay after multilevel posterior cervical spine surgery .
BACKGROUND	However , there is a dearth of literature on prospective study of the efficacy of absorbable gelatin sponge in reducing postoperative blood loss , as well as shortening the length of hospital stay in patients undergoing multilevel posterior lumbar spinal surgery .
METHODS	A total of 82 consecutive patients who underwent multilevel posterior lumbar fusion or posterior lumbar interbody fusion between June 2011 and June 2012 were prospectively randomized into one of the 2 groups according to whether absorbable gelatin sponge for postoperative blood management was used or not .
METHODS	Demographic distribution , total drain output , blood transfusion rate , the length of stay , the number of readmissions , and postoperative complications were analyzed .
RESULTS	Total drain output averaged 173 mL in the study group and 392 mL in the control group ( P = 0.000 ) .
RESULTS	Perioperative allogeneic blood transfusion rate were lower in the Gelfoam group ( 34.1 % vs. 58.5 % , P = 0.046 ) ; moreover , length of stay in patients with the use of absorbable gelatin sponge ( 12.58 d ) was significantly shorter ( P = 0.009 ) than the patients in the control group ( 14.46 d ) .
RESULTS	No patient developed adverse reactions attributable to the absorbable gelatin sponge .
CONCLUSIONS	Application of absorbable gelatin sponge at the end of multilevel posterior lumbar fusion can significantly decrease postoperative drain output and length of hospital stay .

###24491267
BACKGROUND	The haemostatic system plays an important role in the process of cancer development and spread .
BACKGROUND	Anticoagulants , mainly low molecular weight heparins , could prolong survival in cancer patients , particularly in patients with lung cancer , beyond prevention of thromboembolic events .
METHODS	In a multicenter , investigator-initiated , open-label , randomized , sequential study , 38 patients with newly-diagnosed , limited-stage small-cell lung cancer were randomized to receive standard chemoradiotherapy or the same therapy plus 3,500 IU daily of bemiparin for a maximum of 26 weeks .
METHODS	The primary outcome was progression-free survival .
RESULTS	The study was terminated early due to slow recruitment .
RESULTS	Median progression-free survival was 272 days with chemoradiotherapy alone and 410 days in the bemiparin group ; hazard ratio , 2.58 ( 95 % confidence interval [ CI ] , 1.15-5 .80 ) ; p = 0.022 .
RESULTS	Median overall survival was 345 days with chemoradiotherapy alone and 1133 days in the bemiparin group ; hazard ratio , 2.96 ( 95 % CI , 1.22-7 .21 ) ; p = 0.017 .
RESULTS	The rate of tumor response was similar in both study arms .
RESULTS	There was no significant between-group difference in the rates of major bleeding .
RESULTS	Toxicity related with the experimental treatment was minimal .
CONCLUSIONS	The addition of bemiparin to first line therapy with chemoradiotherapy significantly increases survival in patients with newly-diagnosed , limited-stage small-cell lung cancer .
CONCLUSIONS	( Funded by the Instituto Cientfico y Tecnolgico , University of Navarra .
CONCLUSIONS	ClinicalTrials.gov identifier : NCT00324558 ) .

###25053758
OBJECTIVE	To evaluate and compare the results of bipedicle conjunctival flap ( CF ) and cryopreserved amniotic membrane graft ( AMG ) in the treatment of non-viral infectious keratitis resistant to medical treatment .
METHODS	This prospective randomised interventional study included 40 eyes of 40 patients with resistant non-viral infectious keratitis .
METHODS	Twenty eyes received CF and 20 eyes received AMG .
METHODS	In the CF group , there were 12 eyes with fungal keratitis , 7 eyes with bacterial keratitis and 1 eye with Acanthamoeba keratitis .
METHODS	In the AMG group there were 13 eyes with fungal keratitis , 5 eyes with bacterial keratitis and 2 eyes with Acanthamoeba keratitis .
METHODS	In the CF group , three ulcers had descemetocele and four ulcers were perforated .
METHODS	In the AMG group , four ulcers had descemetocele and two ulcers were perforated .
METHODS	In CF , 360 peritomy was done and a bipedicle CF from the upper conjunctiva was dissected from Tenon 's capsule , mobilised to cover the cornea and sutured to episclera .
METHODS	In AMG , one or two layers of AM were trimmed to fit the ulcer and sutured to the cornea .
METHODS	The follow-up period was 6months .
RESULTS	Successful results were observed in 18/20 eyes ( 90 % ) in each group .
RESULTS	Postoperatively , no significant differences between the two groups were found regarding success rate ( p = 1.0 ) , epithelialisation time ( p = 0.75 ) or visual acuity improvement ( p = 0.84 ) .
CONCLUSIONS	CF and AMG are effective in treatment-resistant infectious keratitis .
CONCLUSIONS	They could restore ocular surface integrity and provide metabolic and mechanical support for corneal healing .
CONCLUSIONS	For large corneal perforation , it may be better to use another procedure such as penetrating keratoplasty to restore ocular integrity .

###24503114
OBJECTIVE	Reductions on the clearance from plasma of chylomicrons are associated with atherosclerosis .
OBJECTIVE	Statins improve the removal from plasma of chylomicrons in a dose dependent manner .
OBJECTIVE	There is controversy whether ezetimibe modifies the plasma clearance of chylomicrons .
OBJECTIVE	Effects of ezetimibe alone or in combination with simvastatin were compared with low and high dose of the latter , upon the kinetics of a chylomicron-like emulsion in coronary heart disease ( CHD ) patients .
METHODS	25 CHD patients were randomized for treatment with ezetimibe 10 mg ( group 1 ) or simvastatin 20 mg ( group 2 ) with progression to ezetimibe + simvastatin 10/20 mg or simvastatin 80 mg , respectively .
METHODS	Kinetic studies were performed at baseline and after each treatment period of 6 weeks .
METHODS	The fractional catabolic rates ( FCR ) of the emulsion labeled with ( 14 ) C-CE and ( 3 ) H-TG , that represent respectively chylomicron remnant and triglyceride removal , were calculated .
METHODS	Comparisons were made by ANOVA .
RESULTS	The ( 14 ) CE-FCR in group 1 were 0.005 0.004 , 0.011 0.008 and 0.018 0.005 min ( -1 ) and in group 2 were 0.004 0.003 , 0.011 0.008 and 0.019 0.007 min ( -1 ) respectively at baseline , after 6 and 12 weeks ( p < 0.05 vs. baseline , and 6 vs. 12 weeks ) .
RESULTS	The ( 3 ) H-TG-FCR in group 1 were 0.017 0.011 , 0.024 0.011 and 0.042 0.013 min ( -1 ) and in group 2 were 0.016 0.009 , 0.022 0.009 and 0.037 0.012 min ( -1 ) at baseline , after 6 and 12 weeks ( p < 0.05 vs. baseline , and 6 vs. 12 weeks ) .
RESULTS	There were no differences between groups in time .
CONCLUSIONS	Both treatments increased similarly the removal from plasma of chylomicron and remnants in CHD patients .

###25240737
BACKGROUND	Many older adults are both highly sedentary ( that is , spend considerable amounts of time sitting ) and physically inactive ( that is , do little physical activity ) .
BACKGROUND	This protocol describes an exploratory trial of a theory-based behaviour change intervention in the form of a booklet outlining simple activities ( ` tips ' ) designed both to reduce sedentary behaviour and to increase physical activity in older adults .
BACKGROUND	The intervention is based on the ` habit formation ' model , which proposes that consistent repetition leads to behaviour becoming automatic , sustaining activity gains over time .
METHODS	The intervention is being developed iteratively , in line with Medical Research Council complex intervention guidelines .
METHODS	Selection of activity tips was informed by semi-structured interviews and focus groups with older adults , and input from a multidisciplinary expert panel .
METHODS	An ongoing preliminary field test of acceptability among 25 older adults will inform further refinement .
METHODS	An exploratory randomized controlled trial will be conducted within a primary care setting , comparing the tips booklet with a control fact sheet .
METHODS	Retired , inactive and sedentary adults ( n = 120 ) aged 60 to 74 years , with no physical impairments precluding light physical activity , will be recruited from general practices in north London , UK .
METHODS	The primary outcomes are recruitment and attrition rates .
METHODS	Secondary outcomes are changes in behaviour , habit , health and wellbeing over 12 weeks .
CONCLUSIONS	Data will be used to inform study procedures for a future , larger-scale definitive randomized controlled trial .
BACKGROUND	Current Controlled Trials ISRCTN47901994 .

###24649831
BACKGROUND	Mexico has the highest adult overweight and obesity prevalence in the Americas ; 23.8 % of children < 5 years old are at risk for overweight and 9.7 % are already overweight or obese .
BACKGROUND	Creciendo Sanos was a pilot intervention to prevent obesity among preschoolers in Instituto Mexicano del Seguro Social ( IMSS ) clinics .
METHODS	We randomized 4 IMSS primary care clinics to either 6 weekly educational sessions promoting healthful nutrition and physical activity or usual care .
METHODS	We recruited 306 parent-child pairs : 168 intervention , 138 usual care .
METHODS	Children were 2-5 years old with WHO body mass index ( BMI ) z-score 0-3 .
METHODS	We measured children 's height and weight and parents reported children 's diet and physical activity at baseline and 3 and 6-month follow-up .
METHODS	We analyzed behavioral and BMI outcomes with generalized mixed models incorporating multiple imputation for missing values .
RESULTS	93 ( 55 % ) intervention and 96 ( 70 % ) usual care families completed 3 and 6-month follow-up .
RESULTS	At 3 months , intervention v. usual care children increased vegetables by 6.3 servings/week ( 95 % CI , 1.8 , 10.8 ) .
RESULTS	In stratified analyses , intervention participants with high program adherence ( 5-6 sessions ) decreased snacks and screen time and increased vegetables v. usual care .
RESULTS	No further effects on behavioral outcomes or BMI were observed .
RESULTS	Transportation time and expenses were barriers to adherence .
RESULTS	90 % of parents who completed the post-intervention survey were satisfied with the program .
CONCLUSIONS	Although satisfaction was high among participants , barriers to participation and retention included transportation cost and time .
CONCLUSIONS	In intention to treat analyses , we found intervention effects on vegetable intake , but not other behaviors or BMI .
BACKGROUND	ClinicalTrials.gov NCT01539070.Comisin Nacional de Investigacin Cientfica del IMSS : 2009-785-120 .

###24663007
OBJECTIVE	The aim of this study is to evaluate dentoskeletal effects of Herbst and Twin Block ( TB ) appliance therapies in Skeletal Class II malocclusion .
METHODS	Herbst group consisted of 11 girls and 9 boys ( mean age = 12.74 1.43 years ) , TB group comprised of 10 girls and 10 boys ( mean age = 13.0 1.32 years ) , and control group included 9 girls and 11 boys ( mean age = 12.17 1.47 years ) .
METHODS	Mean treatment/observation times were 15.81 5.96 months for Herbst , 16.20 7.54 months for TB , and 15.58 3.13 months for control group .
METHODS	Pre-treatment ( T0 ) and post-treatment ( T1 ) lateral cephalograms were traced using a modified Pancherz 's cephalometric analysis .
METHODS	Inter-group differences were evaluated with one-way analysis of variance , and intra-group differences were assessed with paired samples t-test at the P < 0.05 level .
RESULTS	In control group , all sagittal and vertical skeletal measurements increased as a result of continuing growth .
RESULTS	However , skeletal discrepancy and overjet remained unchanged .
RESULTS	After functional appliance therapy , greater increases were recorded in TB group for all mandibular skeletal measurements compared with those in control group .
RESULTS	Upper dental arch distalization and lower incisor protrusion were significant in Herbst group , compared with control .
RESULTS	All face height measurements increased after functional appliance therapy .
CONCLUSIONS	In TB group , the treatment effects were mainly due to mandibular skeletal changes .
CONCLUSIONS	Both skeletal and dental changes contribute to Class II correction with Herbst appliance therapy .
CONCLUSIONS	Herbst appliance may be especially useful in Skeletal Class II patients with maxillary dentoalveolar protrusion and mandibular dentoalveolar retrusion , whereas TB appliance may be preferred for skeletal mandibular retrognathy patients .

###24990015
BACKGROUND	Neuropsychological interventions have been mainly applied with clinical populations , in spite of the need of preventing negative changes across life span .
BACKGROUND	Among the few studies of cognitive stimulation in elderly , surprisingly there is no enough research comparing direct and indirect active stimulation programs .
OBJECTIVE	This study aims to verify wheter there are differences between two cognitive interventions approaches in older adults : a structured Working Memory ( WM ) Training Program versus a Poetry-based Stimulation Program .
METHODS	Fourteen older adults were randomly assigned to participate into one of the two intervention groups .
METHODS	The assessed neurocognitive components were attention , episodic and working memory , communicative and executive functions .
METHODS	WM Training activities were based on Baddeley 's model ; Poetry-based Stimulation Program was composed by general language activities .
METHODS	Data were analyzed with one-way ANCOVA with Delta scores and pre and post-training tests raw scores .
RESULTS	WM group improved performance on WM , inhibition , and cognitive flexibility measures , while Poetry group improved on verbal fluency and narrative discourse tasks .
CONCLUSIONS	Both approaches presented benefits ; however WM Training improved its target function with transfer effects to executive functions , being useful for future studies with a variety of dementias .
CONCLUSIONS	Poetry-based Stimulation also improved complex linguistic abilities .
CONCLUSIONS	Both approaches may be helpful as strategies to prevent dysfunctional aging changes .

###25186121
OBJECTIVE	Caregiver involvement is critical in ensuring optimal adolescent asthma management .
OBJECTIVE	The study investigated whether multisystemic therapy ( MST ) , an intensive home-based family therapy , was superior to family support for changing beliefs regarding asthma-related positive parenting among caregivers of African-American youth with poorly controlled asthma .
OBJECTIVE	The relationship between parenting beliefs and asthma management at the conclusion of the intervention was also assessed .
METHODS	A randomized controlled trial was conducted with 167 adolescents with moderate-to-severe , persistent , poorly controlled asthma and their primary caregivers .
METHODS	Families were randomly assigned to MST or family support ( FS ) , a home-based family support condition .
METHODS	Data were collected at baseline and 7-month posttest .
METHODS	Changes in caregiver ratings of importance and confidence for engaging in asthma-related positive parenting were assessed through questionnaire .
METHODS	Illness management was assessed by the Family Asthma Management System Scale .
RESULTS	Participation in MST was associated with more change in caregiver beliefs as compared with FS for both importance ( t = 2.39 , p = .02 ) and confidence ( t = 2.04 , p = .04 ) .
RESULTS	Caregiver beliefs were also significantly related to youth controller medication adherence at the conclusion of treatment ( importance : r = .21 , p = .01 ; confidence : r = .23 , p = .004 ) .
CONCLUSIONS	Results support the effectiveness of MST for increasing parental beliefs in the value of asthma-related positive parenting behaviors and parental self-efficacy for these behaviors among families of minority adolescents with poorly controlled asthma .

###24507164
OBJECTIVE	To evaluate the effect of moderate intensity aerobic exercise ( 40 % -60 % of Heart Rate Reserve ( HRR ) ) on diabetic peripheral neuropathy .
METHODS	A parallel-group , randomized controlled trial was carried out in a tertiary health care setting , India .
METHODS	The study comprised of experimental ( moderate intensity aerobic exercise and standard care ) and control groups ( standard care ) .
METHODS	Population with type 2 diabetes with clinical neuropathy , defined as a minimum score of seven on the Michigan Diabetic Neuropathy Score ( MDNS ) , was randomly assigned to experimental and control groups by computer generated random number tables .
METHODS	RANOVA was used for data analysis ( p < 0.05 was significant ) .
RESULTS	A total of 87 patients with DPN were evaluated in the study .
RESULTS	After randomization there were 47 patients in the control group and 40 patients in the experimental group .
RESULTS	A comparison of two groups using RANOVA for anthropometric measures showed an insignificant change at eight weeks .
RESULTS	For distal peroneal nerve 's conduction velocity there was a significant difference in two groups at eight weeks ( p < 0.05 ) , Degrees of freedom ( Df ) = 1 , 62 , F = 5.14 , and p = 0.03 .
RESULTS	Sural sensory nerve at eight weeks showed a significant difference in two groups for conduction velocity , Df = 1 , 60 , F = 10.16 , and p = 0.00 .
RESULTS	Significant differences in mean scores of MDNS were also observed in the two groups at eight weeks ( p value significant < 0.05 ) .
CONCLUSIONS	Moderate intensity aerobic exercises can play a valuable role to disrupt the normal progression of DPN in type 2 diabetes .

###25071063
BACKGROUND	Regular physical activity is known to help prevent and treat numerous non-communicable diseases .
BACKGROUND	Smartphone applications ( apps ) have been shown to increase physical activity in primary care but little is known regarding the views of patients using such technology or how such technology may change behaviour .
OBJECTIVE	To explore patients ' views and experiences of using smartphones to promote physical activity in primary care .
METHODS	This qualitative study was embedded within the SMART MOVE randomised controlled trial , which used an app ( Accupedo-Pro Pedometer ) to promote physical activity in three primary care centres in the west of Ireland .
METHODS	Taped and transcribed semi-structured interviews with a purposeful sample of 12 participants formed the basis of the investigation .
METHODS	Framework analysis was used to analyse the data .
RESULTS	Four themes emerged from the analysis : transforming relationships with exercise ; persuasive technology tools ; usability ; and the cascade effect .
RESULTS	The app appeared to facilitate a sequential and synergistic process of positive change , which occurred in the relationship between the participants and their exercise behaviour ; the study has termed this the ` Know-Check-Move ' effect .
RESULTS	Usability challenges included increased battery consumption and adjusting to carrying the smartphone on their person .
RESULTS	There was also evidence of a cascade effect involving the families and communities of participants .
CONCLUSIONS	Notwithstanding technological challenges , an app has the potential to positively transform , in a unique way , participants ' relationships with exercise .
CONCLUSIONS	Such interventions can also have an associated cascade effect within their wider families and communities .

###25193889
BACKGROUND	The failure of subacromial decompression may be attributed to persistent symptoms of acromioclavicular joint ( ACJ ) arthritis , while inferior clavicular spurs of the ACJ may be associated with failed healing of repaired rotator cuffs .
OBJECTIVE	To evaluate the clinical effectiveness of arthroscopic distal clavicle resection ( DCR ) in patients with rotator cuff tears and concomitant asymptomatic radiological ACJ arthritis .
METHODS	Randomized controlled trial ; Level of evidence , 1 .
METHODS	A total of 78 patients with rotator cuff tears in addition to radiological and asymptomatic ACJ arthritis who were scheduled for arthroscopic rotator cuff repair were prospectively randomized into 2 groups .
METHODS	Patients underwent arthroscopic rotator cuff repair with acromioplasty .
METHODS	Patients in group 1 ( 39 patients ) underwent additional arthroscopic DCR , while patients in group 2 ( 39 patients ) did not .
METHODS	Clinical outcomes of the 2 groups were compared using the visual analog scale ( VAS ) for pain , range of motion , Constant score , and American Shoulder and Elbow Surgeons ( ASES ) score up to at least 24 months .
METHODS	The structural integrity of repaired rotator cuffs was assessed using ultrasonography , computed tomography arthrography , or MRI at least 6 months after surgery .
METHODS	To evaluate ACJ instability , weighted stress radiography of the ACJ was studied at 6 and 12 months postoperatively .
RESULTS	Patients in both groups showed significant improvement in the VAS score and all functional scores at final follow-up ( mean , 29.2 months ; range , 24-46 months ) without significant differences between the 2 groups ( P > .05 ) .
RESULTS	Results ( mean SD ) for preoperative group 1/group 2 and postoperative group 1/group 2 were as follows , respectively : 7.2 1.8 / 6.1 1.9 ( P = .02 ) and 0.6 1.8 / 0.6 0.9 ( P = .97 ) for the VAS score , 74.1 5.7 / 73.8 8.0 ( P = .87 ) and 96.3 5.7 / 95.7 4.6 ( P = .77 ) for the Constant score , and 47.0 10.3 / 50.8 14.1 ( P = .22 ) and 91.5 15.5 / 94.5 11.8 ( P = .55 ) for the ASES score .
RESULTS	Failed cuff healing occurred in 9 patients ( 23 % ) in group 1 and 10 patients ( 26 % ) in group 2 , with no significant difference ( P = .95 ) .
RESULTS	In group 1 , there were 2 patients ( 5.0 % ) with ACJ subluxation on weighted stress radiography at 6 months postoperatively .
RESULTS	These patients complained of gross protrusion and ACJ tenderness .
CONCLUSIONS	Preventive arthroscopic DCR in patients with rotator cuff tears and concomitant asymptomatic radiological ACJ arthritis did not result in better clinical or structural outcomes , and it did lead to symptomatic ACJ instability in some patients .
CONCLUSIONS	Preventive arthroscopic DCR is not recommended in patients with radiological but asymptomatic ACJ arthritis .
CONCLUSIONS	Further long-term follow-up is needed to confirm the development of symptoms in ACJ arthritis .

###24229738
OBJECTIVE	A prospective double-blind randomized control trial ( RCT ) to evaluate the benefit of a combinatorial , five gene pharmacogenomic test and interpretive report ( GeneSight ) for the management of psychotropic medications used in the treatment of major depression in an outpatient psychiatric practice .
METHODS	Depressed adult outpatients were randomized to a treatment as usual ( TAU , n = 25 ) arm or a pharmacogenomic-informed GeneSight ( n = 26 ) arm .
METHODS	Subjects were blinded to their treatment group and depression severity was assessed by blinded study raters .
METHODS	Within two days of enrollment , clinicians of subjects in the guided group received the GeneSight report that categorized each of 26 psychotropic medications within a green , yellow , or red `` bin '' based on the relationship of each medication to a subject 's pharmacokinetic and pharmacodynamic combinatorial gene variant profile .
METHODS	Antidepressant medication changes began within 2 weeks after baseline assessments .
METHODS	Depression severity was assessed by blinded study raters using the HAMD-17 , PHQ-9 , QIDS-SR , and QIDS-CR administered 4 , 6 , and 10 weeks after baseline assessment .
RESULTS	Between-group trends were observed with greater than double the likelihood of response and remission in the GeneSight group measured by HAMD-17 at week 10 .
RESULTS	Mean percent improvement in depressive symptoms on HAMD-17 was higher for the GeneSight group over TAU ( 30.8 % vs 20.7 % ; p = 0.28 ) .
RESULTS	TAU subjects who had been prescribed medications at baseline that were contraindicated based on the individual subject 's genotype ( i.e. , red bin ) had almost no improvement ( 0.8 % ) in depressive symptoms measured by HAMD-17 at week 10 , which was far less than the 33.1 % improvement ( p = 0.06 ) in the pharmacogenomic guided subjects who started on a red bin medication and the 26.4 % improvement in GeneSight subjects overall ( p = 0.08 ) .
CONCLUSIONS	Pharmaco-genomic-guided treatment with GeneSight doubles the likelihood of response in all patients with treatment resistant depression and identifies 30 % of patients with severe gene-drug interactions who have the greatest improvement in depressive symptoms when switched to genetically suitable medication regimens .

###25379852
OBJECTIVE	To determine the relation between time to surgery ( TTS ) after neoadjuvant chemoradiotherapy ( nCRT ) and pathologically complete response ( pCR ) , surgical outcome , and survival in patients with esophageal cancer .
BACKGROUND	Standard treatment for potentially curable esophageal cancer is nCRT plus surgery after 4 to 6 weeks .
BACKGROUND	In rectal cancer patients , evidence suggests that prolonged TTS is associated with a higher pCR rate and possibly with better survival .
METHODS	We identified patients treated with nCRT plus surgery for esophageal cancer between 2001 and 2011 .
METHODS	TTS ( last day of radiotherapy to day of surgery ) varied mainly for logistical reasons .
METHODS	Minimal follow-up was 24 months .
METHODS	The effect of TTS on pCR rate , postoperative complications , and survival was determined with ( ordinal ) logistic , linear , and Cox regression , respectively .
RESULTS	In total , 325 patients were included .
RESULTS	Median TTS was 48 days ( p25-p75 = 40-60 ) .
RESULTS	After 45 days , TTS was associated with an increased probability of pCR [ odds ratio ( OR ) = 1.35 per additional week of TSS , P = 0.0004 ] and a small increased risk of postoperative complications ( OR = 1.20 , P < 0.001 ) .
RESULTS	Prolonged TTS had no effect on disease-free and overall survivals ( HR = 1.00 and HR = 1.06 per additional week of TSS , P = 0.976 and P = 0.139 , respectively ) .
CONCLUSIONS	Prolonged TTS after nCRT increases the probability of pCR and is associated with a slightly increased probability of postoperative complications , without affecting disease-free and overall survivals .
CONCLUSIONS	We conclude that TTS can be safely prolonged from the usual 4 to 6 weeks up to at least 12 weeks , which facilitates a more conservative wait-and-see strategy after neoadjuvant chemoradiotherapy to be tested .

###24240353
OBJECTIVE	Overnight lens wear is associated with increased lens contamination and risk of developing a corneal infiltrate or infectious event .
OBJECTIVE	Antibacterial lenses have been proposed as a potential strategy for reducing lens contamination .
OBJECTIVE	A proof-of-principle study was conducted to investigate what effect control of potential pathogens , through the use of antibiotic eye drops , would have on the incidence of corneal infiltrative events ( CIEs ) and on the ocular microbiota and lens contamination .
METHODS	This is a prospective , open-label , controlled , parallel-group , 1-month clinical study in which 241 subjects were dispensed with lotrafilcon A silicone hydrogel lenses for 30 days of continuous wear .
METHODS	Subjects were randomized into either test ( moxifloxacin 0.5 % ) or control ( rewetting solution ) group .
METHODS	One drop was instilled into each eye on waking and before sleeping , while lenses were on-eye .
METHODS	Follow-ups were conducted after one night and 1 month .
METHODS	Lid margin swabs were taken at baseline and at 1 month and worn lenses were aseptically collected at 1 month .
RESULTS	The incidence of CIEs was not significantly different between the test ( 2.6 % ) and control ( 3.9 % ) groups ( p = 0.72 ) .
RESULTS	Microorganism levels from the test group swabs were significantly lower than those from the control group ( p = 0.001 ) .
RESULTS	Gram-positive bacteria were less frequently recovered from lower lid swabs from the test group ( 39.6 % vs. 66.0 % [ p < 0.001 ] , test vs. control , respectively ) or from contact lens samples ( 1.9 % vs. 10.5 % [ p = 0.015 ] , test vs. control , respectively ) , but there was no difference in gram-negative bacteria ( GNB ) .
RESULTS	Corneal infiltrative events were associated with higher levels of lens contamination ( p = 0.014 ) and contamination of lenses with GNB ( CIE : 7.3 % vs. 0.6 % [ p = 0.029 ] , GNB contamination vs. no GNB contamination , respectively ) .
CONCLUSIONS	Twice-daily antibiotic instillation during continuous wear of lenses did not significantly influence the rate of inflammatory events .
CONCLUSIONS	Corneal infiltrative events were associated with higher levels of lens contamination in general and with contamination by GNB specifically .

###24621826
BACKGROUND	We aimed to investigate the effect of electroacupuncture at Zusanli ( ST36 ) and Sanyinjiao ( SP6 ) on adrenocortical function in patients with etomidate anesthesia .
METHODS	We randomly divided 80 patients who underwent elective surgery into 4 groups : group etomidate ( ETO ) , group etomidate + electroacupuncture ( ETO+EA ) , group etomidate + sham acupuncture ( ETO+SEA ) , and group propofol ( PRO ) .
METHODS	The patients in group ETO , ETO+EA , and ETO+SEA were induced with etomidate and sufentanil and maintained with intravenous infusion of etomidate and remifentanil .
METHODS	Group PRO was induced with propofol and sufentanil and maintained with propofol and remifentanil .
METHODS	Group ETO+EA received electro-acupuncture stimulation at Zusanli and Sanyinjiao throughout the operation , while group ETO+SEA received electro-acupuncture stimulation at non-acupoints .
METHODS	We recorded the values of MAP , HR , BIS , CVP , cortisol , ACTH , epinephrine , norepinephrine , and arterial blood gas during the perioperative period .
RESULTS	Cortisol concentrations were significantly higher at all times except T0 in group ETO+EA compared with group ETO .
RESULTS	The ACTH concentrations were lower in group ETO+EA than that in group ETO at point T3 .
CONCLUSIONS	Electroacupuncture at ST 36 and SP 6 can mitigate the adrenal cortical inhibition induced by etomidate and can reduce the secretion of catecholamines during surgery .

###24254057
BACKGROUND	The main component in tocotrienols ( T3 ) from barley ( Hordeum vulgare L. ) is - T3 , the vitamer with the highest bioavailability , while palm oil T3 is particularly rich in - T3 .
BACKGROUND	Unlike tocopherols , T3 are known for their cholesterogenesis-inhibiting , neuroprotective and anticarcinogenic properties .
BACKGROUND	In this study the oral bioavailabilities of T3 from barley oil ( 3.98 mgday ) and T3 from palm oil ( 3.36 mgday ) in nanoemulsified formulations ( NE ) and self-emulsifying systems ( SES ) were compared using hen 's eggs as a bioindicator .
BACKGROUND	In addition , the transfer efficiencies of barley oil T3 and palm oil T3 into egg yolk were compared , as well as their effects on egg cholesterol levels .
RESULTS	Nanoemulsification led to T3 levels ( 132.9 g per egg ) higher than with non-emulsified barley oil ( 112.8 g per egg ) and barley oil SES ( 116.7 g per egg ) owing to the high proportions of - T3 ( 99-117g per egg ) , which has a particularly high transfer efficiency ( 4.32-6 .75 % ) .
RESULTS	T3 contents of eggs from hens fed barley oil supplements ( 112-132g per egg ) were significantly higher than those of eggs from hens fed palm oil supplements ( 70-78g per egg ) .
RESULTS	Addition of barley and palm oils to laying hen feed decreased egg yolk cholesterol by 4 and 6 % respectively .
CONCLUSIONS	Results from this animal study may help to establish T3 from barley as a dietary supplement and to develop nutritionally improved hen 's eggs .

###24985147
OBJECTIVE	We aimed to determine the persistence of glycaemic control 1 year after a limited period of intensive glycaemic management of type 2 diabetes .
METHODS	4119 ACCORD Trial participants randomised to target HbA1c < 6.0 % ( 42 mmol/mol ) for 4.0 1.2 years were systematically transitioned to target HbA1c 7.0-7 .9 % ( 53-63 mmol/mol ) and followed for an additional 1.1 0.2 years .
METHODS	Characteristics of participants with HbA1c < 6.5 % ( 48 mmol/mol ) or 6.5 % at transition were compared .
METHODS	Changes in BMI and glucose-lowering medications were compared between those ending with HbA1c < 6.5 % vs 6.5 % .
METHODS	Poisson models were used to assess the independent effect of attaining HbA1c < 6.5 % before transition on ending with HbA1c < 6.5 % .
RESULTS	Participants with pre-transition HbA1c < 6.5 % were older with shorter duration diabetes and took less insulin but more non-insulin glucose-lowering agents than those with higher HbA1c .
RESULTS	A total of 823 participants achieved a final HbA1c < 6.5 % , and had greater post-transition reductions in BMI , insulin dose and secretagogue and acarbose use than those with higher HbA1c ( p < 0.0001 ) .
RESULTS	HbA1c < 6.5 % at transition predicted final HbA1c < 6.5 % ( crude RR 4.9 [ 95 % CI 4.0 , 5.9 ] ; RR 3.9 [ 95 % CI 3.2 , 4.8 ] adjusted for demographics , co-interventions , pre-intervention HbA1c , BMI and glucose-lowering medication , and post-transition change in both BMI and glucose-lowering medication ) .
RESULTS	Progressively lower pre-transition HbA1c levels were associated with a greater likelihood of maintaining a final HbA1c of < 6.5 % .
RESULTS	Follow-up duration was not associated with post-transition rise in HbA1c .
CONCLUSIONS	Time-limited intensive glycaemic management using a combination of agents that achieves HbA1c levels below 6.5 % in established diabetes is associated with glycaemic control more than 1 year after therapy is relaxed .

###25181386
BACKGROUND	Despite amiodarone 's established safety profile in the setting of heart failure , it is unknown whether its impact on cardiovascular outcomes in patients with atrial fibrillation is modulated by left ventricular function .
RESULTS	A pooled analysis of 3,307 patients ( age 68.0 0.2 years ; 31.1 % female ) enrolled in AFFIRM and AF-CHF trials was conducted to assess the effect of rhythm control with amiodarone on cardiovascular outcomes , according to left ventricular systolic function .
RESULTS	In amiodarone-treated patients ( N = 1,107 ) , freedom from recurrent atrial fibrillation was 84 % and 45 % at 1 and 5 years , respectively , with no differences according to left ventricular function ( P = 0.8754 ) .
RESULTS	Similarly , the adjusted proportion of time spent in atrial fibrillation ( 15.0 1.8 % ) did not vary according to ventricular function ( P = 0.6094 ) .
RESULTS	Over 40.0 0.3 months of follow-up , 1,963 ( 59.4 % ) patients required at least one hospitalization , 1,401 ( 42.6 % ) of whom had cardiovascular-related hospitalizations .
RESULTS	Adjusted all-cause and cardiovascular hospitalization rates were similar with amiodarone versus rate control in all patients and in subgroups with and without severe left ventricular dysfunction .
RESULTS	A total of 729 ( 22.0 % ) patients died , 498 ( 15.1 % ) from cardiovascular causes .
RESULTS	Adjusted all-cause and cardiovascular mortality rates were similar with amiodarone versus rate control overall and in subgroups with and without severe left ventricular dysfunction .
CONCLUSIONS	Amiodarone 's efficacy in maintaining sinus rhythm and reducing the burden of atrial fibrillation is similar in the presence or absence of severe left ventricular dysfunction .
CONCLUSIONS	Rhythm control with amiodarone is associated with comparable hospitalization and mortality rates to rate control in patients with and without left ventricular dysfunction .

###25705952
BACKGROUND	Although ablative fractional laser is the gold standard for acne scars , evidence is still lacking for other types of scars .
OBJECTIVE	To evaluate the efficacy and safety of the ablative fractional 10,600-nm CO2 laser in the treatment of various scar types .
METHODS	The authors performed an intraindividual single-blinded randomized controlled split-lesion trial .
METHODS	Adult patients received 3 laser treatments at 8-week intervals for scars existing at least 1 year .
METHODS	Primary end points were the Physician Global Assessment ( PhGA ) and the assessment of adverse effects .
RESULTS	Twenty-five consecutive patients with atrophic ( 52 % ) or hypertrophic ( 48 % ) scars located mainly on the body ( 84 % ) were included in the study .
RESULTS	At 6-month follow-up of 21 patients , the PhGA showed no statistically significant difference between the treated and untreated side of the scar ( p = .70 ) .
RESULTS	Persistent erythema , postinflammatory pigmentary changes , and scarring after ulceration ( n = 3 ) were observed as side effects .
CONCLUSIONS	In this trial involving various types of scars , the efficacy of ablative fractional CO2 laser could not be confirmed .
CONCLUSIONS	The authors presume that different types of scars have a different response to treatment .
CONCLUSIONS	Future studies should aim to identify the type of scars that may benefit from ablative fractional laser therapy .

###24875414
BACKGROUND	Left ventricular dysfunction ( LVD ) is a complex , multifactorial condition , caused by mechanical , neurohormonal , and genetic factors .
BACKGROUND	We have previously observed association of renin-angiotensin-aldosterone system ( RAAS ) , matrix metalloproteinases ( MMPs ) and inflammatory pathway genes with LVD .
BACKGROUND	Therefore the present study was undertaken to identify the combination of genetic variants and their possible interactions contributing towards genetic susceptibility to LVD in the background of coronary artery disease ( CAD ) .
RESULTS	The study included 230 healthy controls and 510 consecutive patients with angiographically confirmed CAD .
RESULTS	Among them , 162 with reduced left ventricle ejection fraction ( LVEF45 % ) were categorized as having LVD .
RESULTS	We analyzed 11 polymorphisms of RAAS , MMPs and inflammatory pathways .
RESULTS	Single locus analysis showed that AT1 A1166C ( p value < 0.001 ; OR = 3.67 ) , MMP9 R668Q ( p value = 0.007 ; OR = 3.48 ) and NFKB1-94 ATTG ins/del ( p value = 0.013 ; OR = 2.01 ) polymorphisms were independently associated with LVD when compared with both non-LVD patients and healthy controls .
RESULTS	High-order gene-gene interaction analysis , using classification and regression tree ( CART ) and multifactor dimensionality reduction ( MDR ) revealed that AT1 A1166C and NFKB1-94 ATTG ins/del polymorphisms jointly increased the risk of LVD to great extent ( p-value = 0.001 ; OR = 8.55 ) and best four-factor interaction model consisted of AT1 A1166C , MMP7 A-181G , MMP9 R668Q and NFKB1-94 ATTG ins/del polymorphisms with testing accuracy of 0.566 and cross validation consistency ( CVC ) = 9/10 ( permutation p < 0.001 ) showed increased risk for LVD respectively .
CONCLUSIONS	AT1 A1166C independently and in combination with MMP9 R668Q and NFKB1-94 ATTG ins/del polymorphisms plays important role in conferring genetic susceptibility to LVD in CAD patients .

###24478226
BACKGROUND	Percutaneous treatment of complex coronary bifurcation lesions remains challenging , even in the drug-eluting stent era .
BACKGROUND	We sought to evaluate the baseline and 9 months intravascular ultrasound ( IVUS ) analysis of the Axxess stent , a self-expanding , Biolimus A9-eluting , and dedicated bifurcation stent .
RESULTS	We enrolled the first 76 patients from selected sites of the 302 patients large DIVERGE trial ( a prospective , single-arm , multicenter trial evaluating the safety and efficacy of the Axxess stent ) .
RESULTS	Both baseline and 9 months IVUS images were collected for serial two-dimensional ( 2D ) and 3D analysis .
RESULTS	A minimal amount and a low percentage of neointimal volume index were seen in the Axxess stent at 9 months ( 0.40.6 mm ( 3 ) / mm and 4.35.2 % , respectively ) .
RESULTS	Vessel , lumen , and stent volume indices increased significantly ( respectively , 17.03.6 to 18.93.7 mm ( 3 ) / mm , P < 0.0001 ; 7.32.0 to 9.22.5 mm ( 3 ) / mm , P < 0.0001 ; and 7.42.0 to 9.62.6 mm ( 3 ) / mm , P < 0.0001 ) .
RESULTS	This resulted in minimum lumen area ( MLA ) enlargement ( 6.11.9 to 7.22.3 mm ( 2 ) , P < 0.0001 ) , whereas peristent plaque area decreased ( 8.72.5 to 8.52.1 mm ( 3 ) / mm , P = 0.016 ) .
RESULTS	At 9 months , 16 ( 26 % ) incomplete stent apposition ( ISA ) persisted from baseline , while six resolved ( 9.7 % ) .
RESULTS	Only one ( 2 % ) ISA was late acquired .
RESULTS	In the additional distal sirolimus-eluting stents , MLA decreased from 4.31.1 to 4.11.2 mm ( 2 ) ( P = 0.04 ) at 9 months for the main branch , and from 3.41.2 to 3.21.2 mm ( 2 ) ( P = 0.09 ) for the side branch .
CONCLUSIONS	The dedicated bifurcation Axxess stent system demonstrates significant stent volume increase with minimal neointimal formation and a low incidence of late-acquired ISA at 9 months .

###24397625
OBJECTIVE	The efficacy and safety of collagenase clostridium histolyticum ( CCH ) in patients with Dupuytren 's contracture ( DC ) was demonstrated in a program including two pivotal phase 3 clinical trials ( CORD I and II ) which included patients with a broad range of disease severity .
OBJECTIVE	This analysis assessed the efficacy and safety of CCH in the subpopulation of DC patients with up to two joints affected and moderate disease according to British Society of Surgery of the Hand classification .
OBJECTIVE	This was in support of a resubmission to the Scottish Medicines Consortium .
METHODS	A post-hoc analysis that included data from patients with up to two joints affected and moderate disease treated with CCH during the randomized and open-label phases of CORD I and II .
RESULTS	Of 362 patients who received CCH during the two trials , 58 had one or two joints affected and moderate disease .
RESULTS	Sixty-seven joints were treated ; 49 patients received treatment for one joint , and 9 patients received treatment for two joints .
RESULTS	Each patient received an average of 1.62 injections of CCH per joint .
RESULTS	Of 65 evaluable joints , 82 % met the primary endpoint of clinical success ( reduction in contracture to 5 of full extension 30 days after the last injection ) .
RESULTS	This was similar if only primary joints were considered ( 81 % achieved clinical success ) .
RESULTS	Recurrence at 12 months ( increase in joint contracture to 20 in the presence of a palpable cord in joints that had attained clinical success ) was observed in 3.8 % of joints .
RESULTS	Reported adverse events were mild to moderate in intensity ; none resulted in discontinuation .
CONCLUSIONS	CORD I and II show that CCH is well tolerated and effective in the treatment of DC in a broad population .
CONCLUSIONS	The present analysis suggests that CCH has particular value in patients with moderate severity disease and up to two joints affected .
CONCLUSIONS	This analysis used data from both the randomized and open-label phases of CORD I and II ; therefore , it is not possible to present comparative data for this subpopulation .
CONCLUSIONS	As this was a post-hoc analysis in a relatively small patient subpopulation , statistical comparisons with the full population were not considered appropriate .
CONCLUSIONS	Furthermore , the small sample size means that additional subgroup analyses , for example of patients by previous treatment or number of injections administered , are not appropriate .
CONCLUSIONS	Nevertheless , the data presented demonstrate that CCH is both well tolerated and effective in this population when managed by appropriately trained individuals .

###25654175
BACKGROUND	International guidelines recommend use of targeted temperature management following resuscitation from out-of-hospital cardiac arrest .
BACKGROUND	This treatment , however , is often neglected or delayed .
OBJECTIVE	To determine whether multifaceted quality improvement interventions would increase the proportion of eligible patients receiving successful targeted temperature management .
METHODS	A network of 6 regional emergency medical services systems and 32 academic and community hospitals serving a population of 8.8 million people providing post arrest care to out-of-hospital cardiac arrest .
METHODS	Comparing interventions improve the implementation of targeted temperature management post out-of-hospital cardiac arrest through passive ( education , generic protocol , order set , local champions ) versus additional active quality improvement interventions ( nurse specialist providing site-specific interventions , monthly audit-feedback , network educational events , internet blog ) versus no intervention ( baseline standard of care ) .
RESULTS	The primary process outcome was proportion of eligible patients receiving successful targeted temperature management , defined as a target temperature of 32-34C within 6 hours of emergency department arrival .
RESULTS	Secondary clinical outcomes included survival and neurological outcome at hospital discharge .
RESULTS	Four thousand three hundred seventeen out-of-hospital cardiac arrests were transported to hospital ; 1,737 ( 40 % ) achieved spontaneous circulation , and 934 ( 22 % ) were eligible for targeted temperature management .
RESULTS	After accounting for secular trends , patients admitted during the passive quality improvement phase were more likely to achieve successful targeted temperature management compared with those admitted during the baseline period ( 25.7 % passive vs 9.0 % baseline ; odds ratio , 2.76 ; 95 % CI , 1.76-4 .32 ; p < 0.001 ) .
RESULTS	Active quality improvement interventions conferred no additional improvements in rates of successful targeted temperature management ( 26.9 % active vs 25.7 % passive ; odds ratio , 0.96 ; 95 % CI , 0.63-1 .45 ; p = 0.84 ) .
RESULTS	Despite a significant increase in rates of successful targeted temperature management , survival to hospital discharge was unchanged .
CONCLUSIONS	Simple quality improvement interventions significantly increased the rates of achieving successful targeted temperature management following out-of-hospital cardiac arrest in a large network of hospitals but did not improve clinical outcomes .

###25057084
OBJECTIVE	To investigate the efficacy and adverse effect of DCF regimen with subsequent S-1 maintenance chemotherapy in patients with advanced gastric cancer ( AGC ) .
METHODS	Sixty AGC patients without disease progression after 4 to 6 cycles of DCF regimen as the first-line chemotherapy were randomized into maintenance group and control group ( 30 patients each ) .
METHODS	The patients in the maintenance group received maintenance chemotherapy with S-1 ( 40 mg/m ( 2 ) , twice daily for 14 days ; 21 days for a treatment cycle ) until disease progression or with intolerant toxicity , and those in the control group received optimal supportive care .
RESULTS	The response rate ( CR+PR ) was 33.3 % in the maintenance group , significantly higher than that in the control group ( 3.33 % , P < 0.05 ) , and the disease control rate ( CR+PR+SD ) also differed significantly between the two groups ( 73.3 % vs 46.7 % , P < 0.05 ) .
RESULTS	The median time to progression was 7.9 months in the maintenance group and 6.8 months in the control group , with median overall survival time of 13.8 and 11.7 months , respectively ( P > 0.05 ) .
RESULTS	The most common adverse effect in the maintenance group included nausea , vomiting , leucocytopenia , and hand-foot syndrome ; no death occurred in relation to the therapy .
CONCLUSIONS	S-1 maintenance chemotherapy , with a tolerable toxicity profile , can improve the RR , DCR and median time to progression in AGC patients who respond to DCF regimen , but its efficacy still awaits further evaluation .

###26103995
BACKGROUND	Those affected by advanced fibrotic interstitial lung diseases ( ILDs ) have considerable unmet symptom and psychological needs .
BACKGROUND	Case conferencing has been proposed to address these issues , but requires evaluation .
OBJECTIVE	To obtain preliminary information on the impact of a case conference intervention delivered in the home ( Hospital2Home ) on palliative care concerns of patients and their carers , and to evaluate feasibility and acceptability .
METHODS	Hospital2Home was trialled at a specialist centre using a Phase II fast-track randomised controlled trial with qualitative interviews .
METHODS	The primary outcome for effect was mean change from baseline of Palliative Care Outcome Scale ( POS ) ( a measure of symptoms and concerns ) at 4weeks .
METHODS	Secondary outcomes included symptom control , quality of life , consent and recruitment rates and percentage of patients in the fast-track group receiving case conferences within 14days .
RESULTS	53 patients were recruited ( 26 fast-track , 27 controls ) .
RESULTS	Mean ( SD ) POS scores at 4weeks were -5.7 ( 7.5 ) fast-track vs -0.4 ( 8.0 ) control , ( mean change difference between the two arms was -5.3 ( 95 % CI -9.8 to -0.7 ) independent t test p = 0.02 ) ; effect size ( 95 % CI ) -0.7 ( -1.2 to -0.1 ) .
RESULTS	The secondary outcomes of quality of life , anxiety and depression were superior in the fast-track arm , and none were worse .
RESULTS	Qualitative findings corroborate these data .
RESULTS	Recruitment was successful and 53/67 ( 79 % ) of eligible patients consented .
RESULTS	6/25 ( 24 % ) had case conferences within 14days .
CONCLUSIONS	Community case conferences improve palliative symptoms and quality of life after 4weeks .
CONCLUSIONS	Hospital2Home for the most part is both feasible and acceptable .
CONCLUSIONS	It now requires further testing in multicentre trials .
BACKGROUND	NCT01450644 .

###25881690
OBJECTIVE	To compare the efficacy of mitiglinide and sitagliptin , alone or in combination , on postprandial excursion and glycemic variability assessed by continuous glucose monitoring ( CGM ) in a single-day treatment setting .
METHODS	This was a post hoc analysis of a randomized crossover study comparing the efficacy of sitagliptin , mitiglinide and the combination of these two drugs .
METHODS	Twenty-four hour CGM was performed before and after a single-day treatment with each drug alone or in combination .
RESULTS	Mean glucose levels were decreased in all groups .
RESULTS	The average of three postprandial glucose excursions AUC ( average of all three 4-h postprandial periods throughout the day ) ( AUCpp-average ) decreased in the mitiglinide and combination treatment groups , but not in the sitagliptin group .
RESULTS	The lowering effect on AUCpp-average was greater in patients given mitiglinide ( -47 mg/dl , p < 0.001 ) or combination treatment ( -66 mg/dl , p < 0.001 ) compared with sitagliptin alone ( -18 mg/dl ) .
RESULTS	The reduction in mean amplitude of glycemic excursion was greater with mitiglinide ( -29.3 mg/dl , p < 0.001 ) and combination treatment ( -28.3 mg/dl , p < 0.01 ) than with sitagliptin alone ( -8.9 mg/dl ) .
CONCLUSIONS	Mitiglinide or combination treatment resulted in lower glycemic variability and postprandial glucose excursion than sitagliptin alone ; however , the results of this single-day pharmacodynamics study can not be generalized to a clinical setting .

###25273036
OBJECTIVE	Patients undergoing coronary bypass grafting ( CABG ) are at higher risk if they suffer from atrial fibrillation ( AF ) .
OBJECTIVE	It was suggested that performing CABG without the use of cardiopulmonary bypass ( off-pump ) would reduce perioperative risk .
OBJECTIVE	We assessed the influence of preoperative AF on outcome in a randomized cohort of patients above the age of 75 undergoing either on-pump or off-pump CABG .
METHODS	The German Off-Pump Coronary Artery Bypass grafting in the Elderly trial , a randomized , controlled multicentre trial conducted at 12 German institutions , enrolled 2303 patients between 2008 and 2011 .
METHODS	The presence of AF was recorded at admission and discharge .
METHODS	There was no record on the rhythm status during hospital stay .
RESULTS	AF at admission was present in 5 % in the on-pump ( 121/1158 ) and 5 % in the off-pump ( 112/1145 ) group .
RESULTS	The number of patients with AF at discharge was not different between these two groups ( 10 % on pump , 10 % off pump ) .
RESULTS	As expected , AF patients had worse preoperative conditions , which had a negative impact on outcome : The combined end-point of death , infarction , stroke , dialysis and revascularization occurred more often ( 13 vs 8 % , P = 0.008 ) and 30-day mortality was significantly higher ( 6 vs 2 % , P = 0.003 ) in AF patients .
RESULTS	However , the operative technique used for CABG did not affect these outcome parameters .
CONCLUSIONS	AF at admission is a significant risk factor for elderly patients undergoing coronary bypass grafting .
CONCLUSIONS	However , this risk is not altered by performing bypass grafting off pump .

###25613307
OBJECTIVE	The purpose is to determine whether patching during carotid endarterectomy ( CEA ) affects the perioperative and long-term risks of restenosis , stroke , death , and myocardial infarction as compared with primary closure .
METHODS	We identified all patients who were randomized and underwent CEA in Carotid Revascularization Endarterectomy versus Stenting Trial .
METHODS	CEA patients who received a patch were compared with patients who underwent CEA with primary closure without a patch .
METHODS	We compared periprocedural and 4-year event rates , 2-year restenosis rates , and rates of reoperation between the 2 groups .
METHODS	We further analyzed results by surgeon specialty .
RESULTS	There were 1151 patients who underwent CEA ( 753 [ 65 % ] with patch and 329 [ 29 % ] with primary closure ) .
RESULTS	We excluded 44 patients who underwent eversion CEA and 25 patients missing CEA data ( 5 % ) .
RESULTS	Patch use differed by surgeon specialty : 89 % of vascular surgeons , 6 % of neurosurgeons , and 76 % of thoracic surgeons patched .
RESULTS	Comparing patients who received a patch versus those who did not , there was a significant reduction in the 2-year risk of restenosis , and this persisted after adjustment by surgeon specialty ( hazard ratio , 0.35 ; 95 % confidence interval , 0.16-0 .74 ; P = 0.006 ) .
RESULTS	There were no significant differences in the rates of periprocedural stroke and death ( hazard ratio , 1.58 ; 95 % confidence interval , 0.33-7 .58 ; P = 0.57 ) , in immediate reoperation ( hazard ratio , 0.6 ; 95 % confidence interval , 0.16-2 .27 ; P = 0.45 ) , or in the 4-year risk of ipsilateral stroke ( hazard ratio , 1.23 ; 95 % confidence interval , 0.42-3 .63 ; P = 0.71 ) .
CONCLUSIONS	Patch closure in CEA is associated with reduction in restenosis although it is not associated with improved clinical outcomes .
CONCLUSIONS	Thus , more widespread use of patching should be considered to improve long-term durability .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00004732 .

###26027612
BACKGROUND	Both acute myocardial ischemia and reperfusion contribute to cardiomyocyte death in ST-elevation myocardial infarction ( STEMI ) .
BACKGROUND	The final infarct size is the principal determinant of subsequent clinical outcome in STEMI patients .
BACKGROUND	In a proof-of-concept phase II trial , the administration of cyclosporine prior to primary percutaneous coronary intervention ( PPCI ) has been associated with a reduction of infarct size in STEMI patients .
METHODS	CIRCUS is an international , prospective , multicenter , randomized , double-blinded , placebo-controlled trial .
METHODS	The study is designed to compare the efficacy and safety of cyclosporine versus placebo , in addition to revascularization by PPCI , in patients presenting with acute anterior myocardial infarction within 12 hours of symptoms onset and initial TIMI flow 1 in the culprit left anterior descending coronary artery .
METHODS	Patients are randomized in a 1:1 fashion to 2.5 mg/kg intravenous infusion of cyclosporine or matching placebo performed in the minutes preceding PCI .
METHODS	The primary efficacy end point of CIRCUS is a composite of 1-year all-cause mortality , rehospitalization for heart failure or heart failure worsening during initial hospitalization , and left ventricular adverse remodeling as determined by sequential transthoracic echochardiography .
METHODS	Secondary outcomes will be tested using a hierarchical sequence of left ventricular ( LV ) ejection fraction and absolute measurements of LV volumes .
METHODS	The composite of death and rehospitalization for heart failure or heart failure worsening during initial hospitalization will be further assessed at three years after the initial infarction .
RESULTS	Recruitment lasted from April 2011 to February 2014 .
RESULTS	The CIRCUS trial has recruited 975 patients with acute anterior myocardial infarction .
RESULTS	The 12-months results are expected to be available in 2015 .
CONCLUSIONS	The CIRCUS trial is testing the hypothesis that cyclosporine in addition to early revascularization with PPCI compared to placebo in patients with acute anterior myocardial infarction reduces the incidence of death , heart failure and adverse LV remodeling at one-year follow-up .

###25445859
BACKGROUND	Patients with frequent asthma exacerbations resulting in emergency department ( ED ) visits are at increased risk for future exacerbations .
BACKGROUND	We examined the ability of 1 dose of benralizumab , an investigational antiinterleukin 5 receptor monoclonal antibody , to reduce recurrence after acute asthma exacerbations .
METHODS	In this randomized , double-blind , placebo-controlled study , eligible subjects presented to the ED with an asthma exacerbation , had partial response to treatment , and greater than or equal to 1 additional exacerbation within the previous year .
METHODS	Subjects received 1 intravenous infusion of placebo ( n = 38 ) or benralizumab ( 0.3 mg/kg , n = 36 or 1.0 mg/kg , n = 36 ) added to outpatient management .
METHODS	The primary outcome was the proportion of subjects with greater than or equal to 1 exacerbation at 12 weeks in placebo vs the combined benralizumab groups .
METHODS	Other outcomes included the time-weighted rate of exacerbations at week 12 , adverse events , blood eosinophil counts , asthma symptom changes , and health care resource utilization .
RESULTS	The proportion of subjects with greater than or equal to 1 asthma exacerbation at 12 weeks was not different between placebo and the combined benralizumab groups ( 38.9 % vs 33.3 % ; P = .67 ) .
RESULTS	However , compared with placebo , benralizumab reduced asthma exacerbation rates by 49 % ( 3.59 vs 1.82 ; P = .01 ) and exacerbations resulting in hospitalization by 60 % ( 1.62 vs 0.65 ; P = .02 ) in the combined groups .
RESULTS	Benralizumab reduced blood eosinophil counts but did not affect other outcomes , while demonstrating an acceptable safety profile .
CONCLUSIONS	When added to usual care , 1 dose of benralizumab reduced the rate and severity of exacerbations experienced over 12 weeks by subjects who presented to the ED with acute asthma .

###24370194
OBJECTIVE	The aim was to study the impact of dietary intervention on the properties of paraffin-stimulated saliva , and on dental caries .
METHODS	At 7 months of age 1062 infants ( 540 intervention ; 522 controls ) started in the prospective , randomized Special Turku Intervention Project ( STRIP ) aimed at restricting the child 's saturated fat and cholesterol intake to prevent atherosclerosis of adult age ( www.clinicaltrials.gov NCT 00223600 ) .
METHODS	At 3 years of age , every fifth child was invited to an oral sub-study , and 148 ( 78 boys ) children attended .
METHODS	At 6 , 9 , 12 and 16 years of age 135 , 127 , 114 and 88 children were restudied , respectively .
METHODS	Dietary intakes of carbohydrates , protein , saturated fat , calcium , phosphate , and fibre were regularly recorded using 4-day food records .
METHODS	Height and weight were regularly monitored .
METHODS	Paraffin-stimulated saliva samples were collected at 6 , 9 , 12 and 16 years of age , and analyzed for flow rate , buffer capacity , calcium , phosphate and proteins .
METHODS	Dental health was recorded and expressed as d3mft/D3MFT , and as time of caries onset .
RESULTS	Dietary intakes of calcium , phosphate and fibre , and salivary flow rate increased with time in both groups ( p < 0.001 , GLM for repeated measures ) .
RESULTS	Fibre intake and salivary flow rate were higher in the intervention than in the control group ( p = 0.042 and p = 0.0394 , respectively , GLM for repeated measures ) .
RESULTS	There were no correlations between dietary intakes and salivary concentrations of calcium or phosphate .
RESULTS	Children who did not have caries experience ( d3mft/D3MFT = 0 ) during the entire follow-up had higher salivary calcium than those who had caries already at 3 years of age .
RESULTS	The association between salivary calcium and caries onset was significant up to 12 years of age .
RESULTS	Toothbrushing frequency was statistically significantly associated with caries-onset at ages 6 ( gamma statistic 0.457 , p = 0.046 ) and 12 years ( gamma statistic 0.473 , p = 0.019 ) .
CONCLUSIONS	The current long-term dietary intervention increased children 's paraffin-stimulated salivary flow rate .
CONCLUSIONS	The concentration of salivary calcium was directly correlated to dental health .
CONCLUSIONS	Higher salivary flow rate in the intervention group is believed to be due to higher fibre intake in the intervention group .

###25018121
BACKGROUND	Dulaglutide and liraglutide , both glucagon-like peptide-1 ( GLP-1 ) receptor agonists , improve glycaemic control and reduce weight in patients with type 2 diabetes .
BACKGROUND	In a head-to-head trial , we compared the safety and efficacy of once-weekly dulaglutide with that of once-daily liraglutide in metformin-treated patients with uncontrolled type 2 diabetes .
METHODS	We did a phase 3 , randomised , open-label , parallel-group study at 62 sites in nine countries between June 20 , 2012 , and Nov 25 , 2013 .
METHODS	Patients with inadequately controlled type 2 diabetes receiving metformin ( 1500 mg/day ) , aged 18 years or older , with glycated haemoglobin ( HbA1c ) 70 % or greater ( 53 mmol/mol ) and 100 % or lower ( 86 mmol/mol ) , and body-mass index 45 kg/m ( 2 ) or lower were randomly assigned to receive once-weekly dulaglutide ( 15 mg ) or once-daily liraglutide ( 18 mg ) .
METHODS	Randomisation was done according to a computer-generated random sequence with an interactive voice response system .
METHODS	Participants and investigators were not masked to treatment allocation .
METHODS	The primary outcome was non-inferiority ( margin 04 % ) of dulaglutide compared with liraglutide for change in HbA1c ( least-squares mean change from baseline ) at 26 weeks .
METHODS	Safety data were collected for a further 4 weeks ' follow-up .
METHODS	Analysis was by intention to treat .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01624259 .
RESULTS	We randomly assigned 599 patients to receive once-weekly dulaglutide ( 299 patients ) or once-daily liraglutide ( 300 patients ) .
RESULTS	269 participants in each group completed treatment at week 26 .
RESULTS	Least-squares mean reduction in HbA1c was -142 % ( SE 005 ) in the dulaglutide group and -136 % ( 005 ) in the liraglutide group .
RESULTS	Mean treatment difference in HbA1c was -006 % ( 95 % CI -019 to 007 , pnon-inferiority < 00001 ) between the two groups .
RESULTS	The most common gastrointestinal adverse events were nausea ( 61 [ 20 % ] in dulaglutide group vs 54 [ 18 % ] in liraglutide group ) , diarrhoea ( 36 [ 12 % ] vs 36 [ 12 % ] ) , dyspepsia ( 24 [ 8 % ] vs 18 [ 6 % ] ) , and vomiting ( 21 [ 7 % ] vs 25 [ 8 % ] ) , with similar rates of study or study drug discontinuation because of adverse events between the two groups ( 18 [ 6 % ] in each group ) .
RESULTS	The hypoglycaemia rate was 034 ( SE 144 ) and 052 ( 301 ) events per patient per year , respectively , and no severe hypoglycaemia was reported .
CONCLUSIONS	Once-weekly dulaglutide is non-inferior to once-daily liraglutide for least-squares mean reduction in HbA1c , with a similar safety and tolerability profile .
BACKGROUND	Eli Lilly and Company .

###24972482
BACKGROUND	Intense physical exercise provoke muscle damage , that in sedentary people can increase cardiovascular risk .
BACKGROUND	Phlebodium decumanum ( PD ) has shown to have immunomodulator effects in models of moderate intense physical activities in well conditioned groups .
BACKGROUND	To evaluate the PD effects during eccentric exercise , as a model of muscle inflammation protocol , on a sedentary population with cardiovascular risk .
METHODS	This is an experimental , double-blind , multigroup randomized study .
METHODS	Experimental Group 1 ( n = 17 ) received PD , 9 doses of 400 mg ( total amount 3.6 g ) every 8 hours during 3 days , and Control Group 2 ( n = 16 ) received a placebo .
METHODS	All the subjects performed two treadmill ergoespirometry tests : first , a modified Bruce protocol to discard ischemic responses during exercise and to evaluate VO2max before the experimental phase ; and second , with an eccentric protocol ( 14 % descending ramp test ) during 10 minutes in stable state at 70-80 % VO2max , as experimental inflammatory protocol.We compared intra and inter groups to evaluate differences in the pre and post-test differences results on blood muscle damage variables .
RESULTS	The study shown statistically significant differences in all pre-post intra-groups results in muscle damage variables ( CK , LDH and Myoglobin , but not in Cardiac Troponin ) , and in functional lower-limb test ( SJand CMJ ) .
RESULTS	The comparison of inter-group results shown less muscle damage and less functional lower-limb deterioration in Group 1 compared with Control group , with statistical significance in both cases .
RESULTS	Differences in handgrip dynamometry were no statistically significant .
CONCLUSIONS	The eccentric exercise protocol in that study has proven to be a good model to induce muscle and functional damage in sedentary people .
CONCLUSIONS	Short PD treatment has shown to reduce muscle and functional acute damages compared with placebo control group in this specific population .

###24861826
BACKGROUND	Stair climbing is a challenging task to the elderly being the task with the first complaint in patients with mild to moderate knee osteoarthritis .
BACKGROUND	Stair climbing results in around six times more compressive load transmitted through the knee joint than walking on level ground .
BACKGROUND	The purpose of this study was to assess whether lateral wedge insoles would reduce medial compartment knee loading when ascending and descending stairs in patients with medial knee osteoarthritis .
METHODS	Eight patients with medial knee osteoarthritis were tested in random order with and without a pair of 5 off-the-shelf lateral wedge insoles for two separate activities ( stair ascent and stair descent ) .
METHODS	Kinematic and kinetic data were collected for the lower extremity using a sixteen camera motion capture system and two force plates .
METHODS	Primary outcome measures were the external knee adduction moment and the knee adduction angular impulse .
RESULTS	During stair ascent and descent , lateral wedge insoles significantly ( P < 0.05 ) reduced the 1st peak external knee adduction moment in early stance ( ascent 6.8 % , descent 8.4 % ) , the trough in mid stance ( ascent 13 % , descent 10.7 % ) , 2nd peak in the late stance ( ascent 15 % , descent 8.3 % ) and the knee adduction angular impulse compared to the control ( standard shoe ) with large effect sizes ( 0.75-0 .95 ) .
CONCLUSIONS	In this first study on stairs , lateral wedge insoles consistently reduced the overall magnitude of medial compartment loading during stair ascent and descent .
CONCLUSIONS	Further research is needed to determine the relationship of this with clinical results when ascending and descending stairs with lateral wedge insoles .

###25832111
BACKGROUND	Previous studies have shown that in psychotherapy alliance is a predictor of symptomatic change , even while accounting for the temporal precedence between alliance and symptoms .
BACKGROUND	However , the extent to which alliance predicts outcomes in psychopharmacology is yet to be fully investigated considering the fact that alliance can be the result , rather than the cause , of symptomatic change .
BACKGROUND	The current prospective study examined whether the alliance predicts outcomes in psychopharmacology , while controlling for previous symptomatic change throughout the course of treatment .
METHODS	Data from a psychopharmacological randomized controlled trial for the treatment of adult major depression ( n = 42 ) , including the patients ' rating of the alliance with the physicians , were analyzed .
METHODS	Multilevel models controlling for autoregressive lag of the dependent variable were used in all analyses to examine the effect of alliance on outcome .
RESULTS	The effect of alliance on outcome , while controlling for prior symptomatic levels , was significant and restricted to the middle phase of treatment ( week 4 , p = 0.005 ) , when most of the reductions in symptoms were observed .
RESULTS	Exploratory analyses of the differences between placebo and medication conditions suggest that the differences between the patients in their average alliance levels predicted a greater reduction in symptoms in the placebo compared to the medication conditions ( p = 0.008 ) .
RESULTS	The main limitation is the small cohort size .
CONCLUSIONS	The findings suggest an effect of alliance on outcome in psychopharmacology , which is not merely the result of previous symptomatic levels .
CONCLUSIONS	This effect may be more robust in conditions that do not include active treatment ( placebo ) , possibly serving as a compensatory effect .

###25128594
OBJECTIVE	To assess tear cytokine levels and clinical outcomes in moderate and severe meibomian gland dysfunction ( MGD ) after 2 months of treatment with topical loteprednol etabonate and eyelid scrubs with warm compresses vs eyelid scrubs with warm compresses alone .
METHODS	Randomized controlled trial .
METHODS	Patients with moderate and severe MGD were randomized into 2 groups : topical loteprednol etabonate and eyelid scrubs with warm compresses ( Group I , 34 eyes ) or eyelid scrubs with warm compresses ( Group II , 36 eyes ) .
METHODS	We evaluated cytokine levels , tear film break-up time ( TBUT ) , corneal and conjunctival fluorescein staining , biomicroscopic examination of lid margins and meibomian glands , and the Ocular Surface Disease Index before initiating treatment and 1 month and 2 months after treatment .
RESULTS	There were significant decreases in the levels of interleukin ( IL ) -6 , IL-8 , and IL-1 in Group I , and IL-6 and IL-8 in Group II .
RESULTS	Moreover , the observed decreases of these cytokines in Group I were attributed to a remarkable decrease between treatment and 1 month after treatment .
RESULTS	In Group I , there were improvements in all of the clinical outcomes , with prominent improvement in TBUT , corneal and conjunctival fluorescein staining , and meibum quality after 1 month of treatment , compared with Group II .
RESULTS	An improvement in meibomian gland expressibility and MGD stage reduction were more remarkable in Group I.
CONCLUSIONS	Topical loteprednol etabonate and eyelid scrubs with warm compresses were tolerated and efficacious for the treatment of moderate and severe MGD .
CONCLUSIONS	We suggest that such beneficial effects could manifest after 1 month .

###24905063
BACKGROUND	Women with primary ovarian insufficiency have significantly lower serum estradiol and T levels compared with regularly menstruating women .
BACKGROUND	They also have significantly reduced bone mineral density ( BMD ) .
OBJECTIVE	The objective of the study was to evaluate the efficacy of hormone replacement in maintaining BMD in these young women .
METHODS	This was a randomized , double-blind , single-center , placebo-controlled clinical trial at the National Institutes of Health clinical center ( Bethesda , Maryland ) .
METHODS	Young women with primary ovarian insufficiency participated in the study .
METHODS	We compared the effect of estradiol and progestin replacement ( n = 72 ) vs estradiol , progestin , and T replacement ( n = 73 ) on BMD .
METHODS	We also compared findings with a contemporaneous control group of normal women ( n = 70 ) .
METHODS	All patients received transdermal estradiol ( 100 g/d ) plus oral medroxyprogesterone acetate 10 mg/d ( 12 d/mo ) for a 3-month run-in period before being randomized in a double-blinded fashion to the addition of transdermal T ( 150 g/d ) or placebo .
METHODS	Change in BMD at the femoral neck was measured by dual-energy x-ray absorptiometry .
RESULTS	At screening , patients had significantly lower femoral neck BMD compared with control women ( 0.77 vs 0.81 g/cm ( 2 ) , P = .001 ) and did not differ in body mass index , age at menarche , or education level .
RESULTS	Normal control women lost femoral neck BMD over the study period , whereas patients on estradiol and progestin therapy gained BMD ; and at the end of the study period , femoral neck BMD of patients on estradiol and progestin therapy did not differ from that of control women ( 0.80 g/cm ( 2 ) in both groups , P = .9 ) .
RESULTS	The addition of T showed no further benefit ( percentage change in BMD 3.9 vs 2.4 , respectively , P = .9 ) .
RESULTS	Nonetheless , using a repeated-measures model , the T group achieved a mean BMD in the femoral neck 0.015 g/cm ( 2 ) higher than the placebo group at 3 years ( 95 % confidence interval -0.005 to 0.034 , P = .13 ) .
RESULTS	Similar findings were observed in the lumbar spine BMD as well .
CONCLUSIONS	Long-term physiological transdermal estradiol replacement in combination with oral medroxyprogesterone acetate restores mean femoral neck BMD to normal in young women with spontaneous 46 , XX primary ovarian insufficiency .
CONCLUSIONS	However , the addition of physiological transdermal T replacement did not provide additional benefit .

###25551855
OBJECTIVE	Medical education today frequently includes standardized patient ( SP ) encounters to teach history-taking , physical exam , and communication skills .
OBJECTIVE	However , traditional wall-mounted cameras , used to record video for faculty and student feedback and evaluation , provide a limited view of key nonverbal communication behaviors during clinical encounters .
METHODS	In 2013 , 30 second-year medical students participated in an end-of-life module that included SP encounters in which the SPs used Google Glass to record their first-person perspective .
METHODS	Students reviewed the Google Glass video and traditional videos and then completed a postencounter , self-evaluation survey and a follow-up survey about the experience .
RESULTS	Google Glass was used successfully to record 30 student/SP encounters .
RESULTS	One temporary Google Glass hardware failure was observed .
RESULTS	Of the 30 students , 7 ( 23 % ) reported a `` positive , nondistracting experience '' ; 11 ( 37 % ) a `` positive , initially distracting experience '' ; 5 ( 17 % ) a `` neutral experience '' ; and 3 ( 10 % ) a `` negative experience . ''
RESULTS	Four students ( 13 % ) opted to withhold judgment until they reviewed the videos but reported Google Glass as `` distracting . ''
RESULTS	According to follow-up survey responses , 16 students ( of 23 ; 70 % ) found Google Glass `` worth including in the [ clinical skills program ] , '' whereas 7 ( 30 % ) did not .
CONCLUSIONS	Google Glass can be used to video record students during SP encounters and provides a novel perspective for the analysis and evaluation of their interpersonal communication skills and nonverbal behaviors .
CONCLUSIONS	Next steps include a larger , more rigorous comparison of Google Glass versus traditional videos and expanded use of this technology in other aspects of the clinical skills training program .

###24651160
OBJECTIVE	Metabolic syndrome ( MetS ) has become an important public concern due to its increasing prevalence .
OBJECTIVE	An altered fatty acid composition has been associated with MetS , but the Mediterranean diet has been shown to have a protective effect .
OBJECTIVE	The aim of the present study was to analyze the influence of a Mediterranean dietary pattern , as assessed by the biomarkers of food supplied , on the plasma fatty acid composition and its relation with MetS after 1 year of intervention .
METHODS	A total of 424 subjects were randomly selected from the PREDIMED randomized dietary trial after completing a 1-year intervention program .
METHODS	Participants aged 55 to 80 years and at high risk of cardiovascular disease were randomly assigned to three dietary interventions : Mediterranean diet supplemented with virgin olive oil or nuts , or a low-fat diet .
RESULTS	After 1 year of intervention participants in the virgin olive oil group showed significantly increased plasma concentrations of palmitic and oleic acids , but reduced proportions of margaric , stearic , and linoleic acids .
RESULTS	In turn , subjects in the nut group showed significantly increased levels of palmitic , linoleic , and - linolenic acids , but reduced proportions of myristic , margaric , palmitoleic , and dihommo -- linoleic acids .
RESULTS	Increases in the biomarkers of foods supplied to the Mediterranean diet groups , i.e. , oleic and - linolenic acids , were beneficially associated with the incidence , reversion and prevalence of MetS .
RESULTS	No weight changes were observed among participants .
CONCLUSIONS	The nut and olive oil diets induced a fatty acid composition that has been shown to be beneficial in the face of MetS .
CONCLUSIONS	Therefore , a Mediterranean diet rich in fats of vegetable origin may be a useful tool for the management of MetS without the need for concerns over weight gain due to its high fat content .
BACKGROUND	Controlled-Trials .
BACKGROUND	com ISRCTN35739639 .

###25823271
OBJECTIVE	To assess the expediency of psychotherapy in patients with essential hypertension ( EH ) from clinical and economic standpoints .
METHODS	Seventy-five ( 37 men , 38 women ) with grades 1-2 EH ( blood pressure ( BP ) was 140/90 to 179/109 mm Hg ) and the verified psychosomatic background of the disease ) were examined and randomized into 2 groups ( the mean age in Groups 1 and 2 was 48.5 3.69 and 47.5 4.2 years , respectively ) .
METHODS	All the patients received medical therapy using the same regimen ; however , Group 1 patients had additionally psychotherapy .
METHODS	The decrease in BP and the average number of visits required to reach goal BP were estimated as a criterion for therapeutic effectiveness .
METHODS	A pharmacoeconomic analysis of antihypertensive therapy was made in each group .
RESULTS	The average cost for 24 weeks was 349.67 rbl per person in Group 1 and 435.9 rbl in Group 2 , which was 19.78 % cheaper .
RESULTS	The costs of reductions in systolic-BP ( SBP ) and diastolic BP ( DBP ) were also lower in Group 1 ( -22.108 and -39.534 rbl , respectively ) .
RESULTS	At the same time , goal BP was achieved more rapidly in Group 1 ( in Groups 1 and 2 , the reduction in SBP was 5.28 and 3.38 mm Hg weekly and that in DBP was 2.51 and 1.73 mm Hg weekly , respectively ) .
RESULTS	This makes it possible to lower a physicians ' load and to save timing budget ( p > 0.032 ) .
CONCLUSIONS	The treatment policy in Group 1 surpassed that in Group 2 in the rate of BP normalization and the number of required visits to a physician and showed significant economic benefits .

###24393375
BACKGROUND	The Fas apoptotic pathway has been implicated in type 2 diabetes and cardiovascular disease .
BACKGROUND	Although a polymorphism ( rs7138803 ; G > A ) near the Fas apoptotic inhibitory molecule 2 ( FAIM2 ) locus has been related to obesity , its association with other cardiovascular risk factors and disease remains uncertain .
METHODS	We analyzed the association between the FAIM2-rs7138803 polymorphism and obesity , blood pressure and heart rate in 7,161 participants ( 48.3 % with type 2 diabetes ) in the PREDIMED study at baseline .
METHODS	We also explored gene-diet interactions with adherence to the Mediterranean diet ( MedDiet ) and examined the effects of the polymorphism on cardiovascular disease incidence per diabetes status after a median 4.8-year dietary intervention ( MedDiet versus control group ) follow-up .
RESULTS	We replicated the association between the FAIM2-rs7138803 polymorphism and greater obesity risk ( OR : 1.08 ; 95 % CI : 1.01-1 .16 ; P = 0.011 ; per-A allele ) .
RESULTS	Moreover , we detected novel associations of this polymorphism with higher diastolic blood pressure ( DBP ) and heart rate at baseline ( B = 1.07 ; 95 % CI : 0.97-1 .28 bmp in AA vs G-carriers for the whole population ) , that remained statistically significant even after adjustment for body mass index ( P = 0.012 ) and correction for multiple comparisons .
RESULTS	This association was greater and statistically significant in type-2 diabetic subjects ( B = 1.44 : 95 % CI : 0.23-2 .56 bmp ; P = 0.010 for AA versus G-carriers ) .
RESULTS	Likewise , these findings were also observed longitudinally over 5-year follow-up .
RESULTS	Nevertheless , we found no statistically significant gene-diet interactions with MedDiet for this trait .
RESULTS	On analyzing myocardial infarction risk , we detected a nominally significant ( P = 0.041 ) association in type-2 diabetic subjects ( HR : 1.86 ; 95 % CI :1.03 -3.37 for AA versus G-carriers ) , although this association did not remain statistically significant following correction for multiple comparisons .
CONCLUSIONS	We confirmed the FAIM2-rs7138803 relationship with obesity and identified novel and consistent associations with heart rate in particular in type 2 diabetic subjects .
CONCLUSIONS	Furthermore , our results suggest a possible association of this polymorphism with higher myocardial infarction risk in type-2 diabetic subjects , although this result needs to be replicated as it could represent a false positive .

###26016869
BACKGROUND	Public health strategies to lower cardiovascular disease ( CVD ) risk involve reducing dietary saturated fatty acid ( SFA ) intake to 10 % of total energy ( % TE ) .
BACKGROUND	However , the optimal type of replacement fat is unclear .
OBJECTIVE	We investigated the substitution of 9.5-9 .6 % TE dietary SFAs with either monounsaturated fatty acids ( MUFAs ) or n-6 ( -6 ) polyunsaturated fatty acids ( PUFAs ) on vascular function and other CVD risk factors .
METHODS	In a randomized , controlled , single-blind , parallel-group dietary intervention , 195 men and women aged 21-60 y from the United Kingdom with moderate CVD risk ( 50 % above the population mean ) followed one of three 16-wk isoenergetic diets ( % TE target compositions , total fat : SFA : MUFA : n-6 PUFA ) that were rich in SFAs ( 36:17:11:4 , n = 65 ) , MUFAs ( 36:9:19:4 , n = 64 ) , or n-6 PUFAs ( 36:9:13:10 , n = 66 ) .
METHODS	The primary outcome measure was flow-mediated dilatation ; secondary outcome measures included fasting serum lipids , microvascular reactivity , arterial stiffness , ambulatory blood pressure , and markers of insulin resistance , inflammation , and endothelial activation .
RESULTS	Replacing SFAs with MUFAs or n-6 PUFAs did not affect the percentage of flow-mediated dilatation ( primary endpoint ) or other measures of vascular reactivity .
RESULTS	Of the secondary outcome measures , substitution of SFAs with MUFAs attenuated the increase in night systolic blood pressure ( -4.9 mm Hg , P = 0.019 ) and reduced E-selectin ( -7.8 % , P = 0.012 ) .
RESULTS	Replacement with MUFAs or n-6 PUFAs lowered fasting serum total cholesterol ( -8.4 % and -9.2 % , respectively ) , low-density lipoprotein cholesterol ( -11.3 % and -13.6 % ) , and total cholesterol to high-density lipoprotein cholesterol ratio ( -5.6 % and -8.5 % ) ( P 0.001 ) .
RESULTS	These changes in low-density lipoprotein cholesterol equate to an estimated 17-20 % reduction in CVD mortality .
CONCLUSIONS	Substitution of 9.5-9 .6 % TE dietary SFAs with either MUFAs or n-6 PUFAs did not significantly affect the percentage of flow-mediated dilatation or other measures of vascular function .
CONCLUSIONS	However , the beneficial effects on serum lipid biomarkers , blood pressure , and E-selectin offer a potential public health strategy for CVD risk reduction .
CONCLUSIONS	This trial was registered at www.clinicaltrials.gov as NCT01478958 .

###24720376
OBJECTIVE	Tobacco and cannabis use are both highly prevalent worldwide .
OBJECTIVE	Their co-use is also common in adults and adolescents .
OBJECTIVE	Despite this frequent co-occurrence , cessation from both substances is rarely addressed in randomized clinical trials .
OBJECTIVE	Given evidence that tobacco use may increase during cannabis cessation attempts , and additionally that tobacco users have poorer cannabis cessation outcomes , we explored tobacco outcomes , specifically cigarette smoking , from an adolescent cannabis cessation trial that tested the efficacy of N-acetylesteine ( NAC ) .
METHODS	Cannabis-dependent adolescents ( ages 15-21 ; n = 116 ) interested in cannabis treatment were randomized to NAC ( 1200mg bid ) or matched placebo for 8 weeks .
METHODS	Participants did not need to be cigarette smokers or be interested in smoking cessation to qualify for inclusion .
RESULTS	Approximately 59 % of enrolled participants were daily and non-daily cigarette smokers , and only differed from non-smoking participants on the compulsion sub-scale of the Marijuana Craving Questionnaire .
RESULTS	Among cigarette smokers who were retained in the study , there was no change in cigarettes per day for either NAC or placebo groups during the eight-week treatment phase .
RESULTS	Being a cigarette smoker did not appear to influence the effects of NAC on cannabis abstinence , though there was a trend in the placebo group of poorer cannabis outcomes for cigarette smokers vs. non-smokers .
CONCLUSIONS	No evidence was found of compensatory cigarette smoking during this cannabis cessation trial in adolescents .
CONCLUSIONS	Further work assessing interventions to reduce both cannabis and tobacco use in this population is greatly needed .

###24856460
OBJECTIVE	The aim was to develop a method for the purpose of localizing epilepsy related hemodynamic foci for patients suffering intractable focal epilepsy using task-free fMRI alone .
METHODS	We studied three groups of subjects : patients with intractable focal epilepsy , healthy volunteers performing motor tasks , and healthy volunteers in resting state .
METHODS	We performed spatial independent component analysis ( ICA ) on the fMRI alone data and developed a set of IC selection criteria to identify epilepsy related ICs .
METHODS	The method was then tested in the two healthy groups .
RESULTS	In seven out of the nine surgery patients , identified ICs were concordant with surgical resection .
RESULTS	Our results were also consistent with presurgical evaluation of the remaining one patient without surgery and may explain why she was not suitable for resection treatment .
RESULTS	In the motor task study of ten healthy subjects , our method revealed components with concordant spatial and temporal features as expected from the unilateral motor tasks .
RESULTS	In the resting state study of seven healthy subjects , the method successfully rejected all components in four out of seven subjects as non-epilepsy related components .
CONCLUSIONS	These results suggest the lateralization and localization value of fMRI alone in presurgical evaluation for patients with intractable unilateral focal epilepsy .
CONCLUSIONS	The proposed method is noninvasive in nature and easy to implement .
CONCLUSIONS	It has the potential to be incorporated in current presurgical workup for treating intractable focal epilepsy patients .

###24410903
BACKGROUND	In vitro studies rank walnuts ( Juglans regia ) among the plant foods high in antioxidant capacity , but whether the active constituents of walnuts are bioavailable to humans remains to be determined .
BACKGROUND	The intention of this study was to examine the acute effects of consuming walnuts compared to refined fat on meal induced oxidative stress .
BACKGROUND	At issue is whether the ellagitannins and tocopherols in walnuts are bioavailable and provide postprandial antioxidant protection .
METHODS	A randomized , crossover , and controlled-feeding study was conducted to evaluate a walnut test meal compared to one composed of refined ingredients on postprandial serum antioxidants and biomarkers of oxidative status in healthy adults ( n = 16 ) with at least 1 week between testing sessions .
METHODS	Following consumption of a low phenolic diet for one day and an overnight fast , blood was sampled prior to the test meals and at intervals up to 24 hours post ingestion and analyzed for total phenols , malondiadehyde ( MDA ) , oxidized LDL , ferric reducing antioxidant power ( FRAP ) , hydrophilic and lipophilic oxygen radical absorbance capacity ( ORAC ) , uric acid , catechins and urinary excretion of phenylacetate metabolites and of urolithin A.
RESULTS	Mixed linear models demonstrated a diet effect ( P < 0.001 ) for plasma - tocopherol but not for - tocopherol with the walnut meal .
RESULTS	Following the walnut test meal , the incremental 5 hour area under the curve ( AUC ( 0-5h ) ) was reduced 7.4 % for MDA , increased 7.5 % for hydrophilic and 8.5 % for lipophilic ORAC and comparable for total phenols , FRAP and uric acid .
RESULTS	Oxidized LDL was reduced at 2 hours after the walnut meal .
RESULTS	Plasma concentrations of gallocatechin gallate ( GCG ) , epicatechin gallate ( ECG ) and epicallocatechin gallate ( EGCG ) increased significantly at 1 hour after the walnut test meal .
RESULTS	Quantities of urolithin-A excreted in the urine were significantly higher following the walnut meal .
CONCLUSIONS	Compared to the refined control meal , the walnut meal acutely increased postprandial - tocopherol and catechins and attenuated some measures of oxidative stress .

###24500150
BACKGROUND	Observational studies have indicated that differences in the composition of human milk and infant formula yield benefits in cognitive development and early growth for breastfed infants .
OBJECTIVE	The objective was to test the hypothesis that feeding an infant formula with reduced energy and protein densities and supplemented with bovine milk fat globule membrane ( MFGM ) reduces differences in cognitive development and early growth between formula-fed and breastfed infants .
METHODS	In a prospective , double-blind , randomized controlled trial , 160 infants < 2 mo of age were randomly assigned to be fed an MFGM-supplemented , low-energy , low-protein experimental formula ( EF ) or a standard formula ( SF ) until 6 mo of age .
METHODS	The energy and protein contents of the EF and SF were 60 and 66 kcal/100 mL and 1.20 and 1.27 g/100 mL , respectively .
METHODS	A breastfed reference ( BFR ) group consisted of 80 infants .
RESULTS	At 12 mo of age , the cognitive score ( mean SD ) on testing with the Bayley Scales of Infant and Toddler Development , Third Edition , was significantly higher in the EF group than in the SF group ( 105.8 9.2 compared with 101.8 8.0 ; P = 0.008 ) but was not significantly different from that in the BFR group ( 106.4 9.5 ; P = 0.73 ) .
RESULTS	The EF group ingested larger volumes of formula than did the SF group ( 864 174 compared with 797 165 mL/d ; P = 0.022 ) , fully compensating for the lower energy density .
RESULTS	No significant differences in linear growth , weight gain , body mass index , percentage body fat , or head circumference were found between the EF and SF groups .
CONCLUSIONS	MFGM supplementation to infant formula narrows the gap in cognitive development between breastfed and formula-fed infants .
CONCLUSIONS	Between 2 and 6 mo of age , formula-fed term infants have the capacity to upregulate their ingested volumes when the energy density of formula is reduced from 66 to 60 kcal/100 mL .

###24443174
BACKGROUND	We present the final results of the effect of lung cancer screening with low-dose CT on the smoking habits of participants in a 5-year screening trial .
METHODS	The Danish Lung Cancer Screening Trial ( DLCST ) was a 5-year screening trial that enrolled 4104 subjects ; 2052 were randomised to annual low-dose CT ( CT group ) and 2052 received no intervention ( control group ) .
METHODS	Participants were current and ex-smokers ( 4weeks abstinence from smoking ) with a tobacco consumption of 20 pack years .
METHODS	Smoking habits were determined annually .
METHODS	Missing values for smoking status at the final screening round were handled using two different models .
RESULTS	There were no statistically significant differences in annual smoking status between the CT group and control group .
RESULTS	Overall the ex-smoker rates ( CT + control group ) significantly increased from 24 % ( baseline ) to 37 % at year 5 of screening ( p < 0.001 ) .
RESULTS	The annual point prevalence quit rate increased from 11 % to 24 % during the five screening rounds ; the ex-smokers ' relapse rate remained stable , around 11 % , across the same period .
CONCLUSIONS	Screening with low-dose CT had no extra effect on smoking status compared with the control group , but overall the screening programme probably promoted smoking cessation .
BACKGROUND	The DLCST is registered in Clinical Trials.gov Protocol Registration System ( identification no .
BACKGROUND	NCT00496977 ) .

###25445871
OBJECTIVE	Data suggest that capnography is a more sensitive measure of ventilation than standard modalities and detects respiratory depression before hypoxemia occurs .
OBJECTIVE	We sought to determine if adding capnography to standard monitoring during sedation of children increased the frequency of interventions for hypoventilation , and whether these interventions would decrease the frequency of oxygen desaturations .
METHODS	We enrolled 154 children receiving procedural sedation in a pediatric emergency department .
METHODS	All subjects received standard monitoring and capnography , but were randomized to whether staff could view the capnography monitor ( intervention ) or were blinded to it ( controls ) .
METHODS	Primary outcome were the rate of interventions provided by staff for hypoventilation and the rate of oxygen desaturation less than 95 % .
RESULTS	Seventy-seven children were randomized to each group .
RESULTS	Forty-five percent had at least 1 episode of hypoventilation .
RESULTS	The rate of hypoventilation per minute was significantly higher among controls ( 7.1 % vs 1.0 % , P = .008 ) .
RESULTS	There were significantly fewer interventions in the intervention group than in the control group ( odds ratio , 0.25 ; 95 % confidence interval [ CI ] , 0.13-0 .50 ) .
RESULTS	Interventions were more likely to occur contemporaneously with hypoventilation in the intervention group ( 2.26 ; 95 % CI , 1.34-3 .81 ) .
RESULTS	Interventions not in time with hypoventilation were associated with higher odds of oxygen desaturation less than 95 % ( odds ratio , 5.31 ; 95 % CI , 2.76-10 .22 ) .
CONCLUSIONS	Hypoventilation is common during sedation of pediatric emergency department patients .
CONCLUSIONS	This can be difficult to detect by current monitoring methods other than capnography .
CONCLUSIONS	Providers with access to capnography provided fewer but more timely interventions for hypoventilation .
CONCLUSIONS	This led to fewer episodes of hypoventilation and of oxygen desaturation .

###24253785
METHODS	Prospective , parallel-group , controlled , comparative randomized study .
OBJECTIVE	To compare cement leakage rate and efficacy for vertebral body restoration of balloon kyphoplasty ( BK ) versus Kiva novel implant with polymethylmethacrylate ( PMMA ) for treating osteolytic vertebral body metastasis .
BACKGROUND	Minimally invasively vertebral augmentation techniques with PMMA are mostly performed for treating osteoporotic compression fractures .
BACKGROUND	The Kiva implant with PMMA offers better vertebral body restoration and less PMMA leakage than BK in osteoporotic fractures .
BACKGROUND	No previous study compared leakage rate and efficacy for vertebral body restoration in traditional BK and Kiva with PMMA in osteolytic vertebral body metastases .
METHODS	This study examined 23 patients ( 71 13 yr ) with 41 osteolytic vertebral bodies , who received Kiva with low viscosity PMMA and 24 patients ( 70 11 yr ) with 43 vertebral body osteolyses , who were reinforced with BK and high viscosity PMMA .
METHODS	All osteolyses were graded as Tomita 1 to 3 .
METHODS	Anterior vertebral body height ratio ( AVBHr ) , posterior vertebral body height ratio ( PVBHr ) , and middle vertebral body height ratio ( MVBHr ) , Gardner kyphotic deformity , PMMA leakage and were measured and compared between the groups .
METHODS	Visual analogue scale and Oswestry Disability Index were used for functional outcome evaluation .
RESULTS	No patient survived after 3 months .
RESULTS	Asymptomatic PMMA leakage occurred in 4 ( 9.3 % ) vertebrae in the BK group solely ( 2 to the spinal canal , in Tomita grade 3 osteolysis ) Anterior , posterior and middle vertebral body height ratio , Gardner angle improved insignificantly in both groups .
RESULTS	Visual anlogue scale and Oswestry Disability Index improved postoperatively similarly in both groups ( P < 0.001 ) .
CONCLUSIONS	BK and Kiva provided equally significant spinal pain relief in patients with cancer with osteolytic metastasis .
CONCLUSIONS	The absence of cement leakage in the Kiva group and absence of neurological complication in the BK group leakages reflects the safety of both augmentation techniques even in significant osteolysis .
CONCLUSIONS	The lack of cement leakage in the Kiva cases , although low viscosity PMMA was used , increases this implant safety in augmenting severely destructed thoracolumbar vertebrae and sacrum from osteolytic metastasis .
METHODS	1 .

###25480462
OBJECTIVE	Unexplained painful physical symptoms are commonly reported by depressed patients .
OBJECTIVE	The evidence suggests that dual-action antidepressants are potent in relieving pain in depression .
OBJECTIVE	However , a direct comparison of the effects of selective serotonergic and selective noradrenergic antidepressants on painful symptoms has not been investigated so far .
METHODS	Sixty patients who participated in the Genome-based Therapeutic Drugs for Depression study with a diagnosis of moderate or severe episodes of depression according to the International Classification of Diseases , 10th Revision , and the Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , criteria were involved .
METHODS	All the participants were randomly allocated to receive nortriptyline or escitalopram .
METHODS	The severity of depression was measured using the Montgomery-sberg Depression Rating Scale , the Hamilton Depression Rating Scale and the Beck Depression Inventory at weeks 0 , 2 , 4 , 6 and 8 .
METHODS	The intensity of pain was measured on the Visual Analog Scale at the same points of the study .
RESULTS	At `` week 0 , '' 83.3 % of the patients later randomized to treatment with escitalopram and 86.7 % of those treated with nortriptyline reported at least one painful symptom .
RESULTS	A significant decrease of pain intensity was observed after 2 weeks of treatment .
RESULTS	The two groups did not differ in degree of pain reduction at weeks 2 , 4 , 6 and 8 in comparison to baseline values .
RESULTS	A 50 % reduction in pain intensity preceded the 50 % reduction of depression severity .
RESULTS	The intensity of pain at `` week 0 '' did not differ in remitted or nonremitted patients at week 8 .
CONCLUSIONS	Both selective serotonergic and selective noradrenergic antidepressants are equally effective in alleviations of painful physical symptoms of depression .
CONCLUSIONS	The presence of painful symptoms before the onset of treatment did not determine the final response .

###25513807
BACKGROUND	The success of HIV programs relies on widely accessible HIV testing and counseling ( HTC ) services at health facilities as well as in the community .
BACKGROUND	Home-based HTC ( HB-HTC ) is a popular community-based approach to reach persons who do not test at health facilities .
BACKGROUND	Data comparing HB-HTC to other community-based HTC approaches are very limited .
BACKGROUND	This trial compares HB-HTC to mobile clinic HTC ( MC-HTC ) .
RESULTS	The trial was powered to test the hypothesis of higher HTC uptake in HB-HTC campaigns than in MC-HTC campaigns .
RESULTS	Twelve clusters were randomly allocated to HB-HTC or MC-HTC .
RESULTS	The six clusters in the HB-HTC group received 30 1-d multi-disease campaigns ( five villages per cluster ) that delivered services by going door-to-door , whereas the six clusters in MC-HTC group received campaigns involving community gatherings in the 30 villages with subsequent service provision in mobile clinics .
RESULTS	Time allocation and human resources were standardized and equal in both groups .
RESULTS	All individuals accessing the campaigns with unknown HIV status or whose last HIV test was > 12 wk ago and was negative were eligible .
RESULTS	All outcomes were assessed at the individual level .
RESULTS	Statistical analysis used multivariable logistic regression .
RESULTS	Odds ratios and p-values were adjusted for gender , age , and cluster effect .
RESULTS	Out of 3,197 participants from the 12 clusters , 2,563 ( 80.2 % ) were eligible ( HB-HTC : 1,171 ; MC-HTC : 1,392 ) .
RESULTS	The results for the primary outcomes were as follows .
RESULTS	Overall HTC uptake was higher in the HB-HTC group than in the MC-HTC group ( 92.5 % versus 86.7 % ; adjusted odds ratio [ aOR ] : 2.06 ; 95 % CI : 1.18-3 .60 ; p = 0.011 ) .
RESULTS	Among adolescents and adults 12 y , HTC uptake did not differ significantly between the two groups ; however , in children < 12 y , HTC uptake was higher in the HB-HTC arm ( 87.5 % versus 58.7 % ; aOR : 4.91 ; 95 % CI : 2.41-10 .0 ; p < 0.001 ) .
RESULTS	Out of those who took up HTC , 114 ( 4.9 % ) tested HIV-positive , 39 ( 3.6 % ) in the HB-HTC arm and 75 ( 6.2 % ) in the MC-HTC arm ( aOR : 0.64 ; 95 % CI : 0.48-0 .86 ; p = 0.002 ) .
RESULTS	Ten ( 25.6 % ) and 19 ( 25.3 % ) individuals in the HB-HTC and in the MC-HTC arms , respectively , linked to HIV care within 1 mo after testing positive .
RESULTS	Findings for secondary outcomes were as follows : HB-HTC reached more first-time testers , particularly among adolescents and young adults , and had a higher proportion of men among participants .
RESULTS	However , after adjusting for clustering , the difference in male participation was not significant anymore .
RESULTS	Age distribution among participants and immunological and clinical stages among persons newly diagnosed HIV-positive did not differ significantly between the two groups .
RESULTS	Major study limitations included the campaigns ' restriction to weekdays and a relatively low HIV prevalence among participants , the latter indicating that both arms may have reached an underexposed population .
CONCLUSIONS	This study demonstrates that both HB-HTC and MC-HTC can achieve high uptake of HTC .
CONCLUSIONS	The choice between these two community-based strategies will depend on the objective of the activity : HB-HTC was better in reaching children , individuals who had never tested before , and men , while MC-HTC detected more new HIV infections .
CONCLUSIONS	The low rate of linkage to care after a positive HIV test warrants future consideration of combining community-based HTC approaches with strategies to improve linkage to care for persons who test HIV-positive .
BACKGROUND	ClinicalTrials.gov NCT01459120 .
BACKGROUND	Please see later in the article for the Editors ' Summary .

###24241212
OBJECTIVE	Linifanib is a selective inhibitor of the vascular endothelial growth factor and platelet-derived growth factor family of tyrosine kinase inhibitors .
OBJECTIVE	The purpose of this high-precision QT study was to evaluate the effects of linifanib on cardiac repolarization in patients with advanced metastatic tumors .
METHODS	Enrolled patients ( n = 24 ) had measurable disease refractory to standard therapies , ECOG performance status of 0-1 , and adequate organ function .
METHODS	Patients were randomized in a 2-sequence , 2-period crossover design .
METHODS	Serial ECG measurements and pharmacokinetic samples were collected for each crossover period .
METHODS	An intersection-union test was performed for time-matched baseline-adjusted QTcF intervals .
METHODS	An exposure-response analysis was explored to correlate the plasma concentration and QTcF .
RESULTS	The maximum 95 % upper confidence bound for the baseline-adjusted QTcF was 4.3 ms at hour 3 at the maximum tolerated linifanib dose of 0.25 mg/kg .
RESULTS	Linifanib did not meet the regulatory threshold ( 10 ms ) for QT prolongation .
RESULTS	Exposure-response modeling showed that the QTcF change was not significant at the maximum plasma concentration .
CONCLUSIONS	Linifanib does not significantly affect cardiac repolarization in patients with advanced solid tumors .

###25117129
OBJECTIVE	Colorectal cancer is a major health burden .
OBJECTIVE	Screening is recommended in many countries .
OBJECTIVE	To estimate the effectiveness of flexible sigmoidoscopy screening on colorectal cancer incidence and mortality in a population-based trial .
METHODS	Randomized clinical trial of 100,210 individuals aged 50 to 64 years , identified from the population of Oslo city and Telemark County , Norway .
METHODS	Screening was performed in 1999-2000 ( 55-64-year age group ) and in 2001 ( 50-54-year age group ) , with follow-up ending December 31 , 2011 .
METHODS	Of those selected , 1415 were excluded due to prior colorectal cancer , emigration , or death , and 3 could not be traced in the population registry .
METHODS	Participants randomized to the screening group were invited to undergo screening .
METHODS	Within the screening group , participants were randomized 1:1 to receive once-only flexible sigmoidoscopy or combination of once-only flexible sigmoidoscopy and fecal occult blood testing ( FOBT ) .
METHODS	Participants with positive screening test results ( cancer , adenoma , polyp 10 mm , or positive FOBT ) were offered colonoscopy .
METHODS	The control group received no intervention .
METHODS	Colorectal cancer incidence and mortality .
RESULTS	A total of 98,792 participants were included in the intention-to-screen analyses , of whom 78,220 comprised the control group and 20,572 comprised the screening group ( 10,283 randomized to receive a flexible sigmoidoscopy and 10,289 to receive flexible sigmoidoscopy and FOBT ) .
RESULTS	Adherence with screening was 63 % .
RESULTS	After a median of 10.9 years , 71 participants died of colorectal cancer in the screening group vs 330 in the control group ( 31.4 vs 43.1 deaths per 100,000 person-years ; absolute rate difference , 11.7 [ 95 % CI , 3.0-20 .4 ] ; hazard ratio [ HR ] , 0.73 [ 95 % CI , 0.56-0 .94 ] ) .
RESULTS	Colorectal cancer was diagnosed in 253 participants in the screening group vs 1086 in the control group ( 112.6 vs 141.0 cases per 100,000 person-years ; absolute rate difference , 28.4 [ 95 % CI , 12.1-44 .7 ] ; HR , 0.80 [ 95 % CI , 0.70-0 .92 ] ) .
RESULTS	Colorectal cancer incidence was reduced in both the 50 - to 54-year age group ( HR , 0.68 ; 95 % CI , 0.49-0 .94 ) and the 55 - to 64-year age group ( HR , 0.83 ; 95 % CI , 0.71-0 .96 ) .
RESULTS	There was no difference between the flexible sigmoidoscopy only vs the flexible sigmoidoscopy and FOBT screening groups .
CONCLUSIONS	In Norway , once-only flexible sigmoidoscopy screening or flexible sigmoidoscopy and FOBT reduced colorectal cancer incidence and mortality on a population level compared with no screening .
CONCLUSIONS	Screening was effective both in the 50 - to 54-year and the 55 - to 64-year age groups .
BACKGROUND	clinicaltrials.gov Identifier : NCT00119912 .

###24947792
OBJECTIVE	In observational studies , low serum 25-hydroxyvitamin D [ 25 ( OH ) D ] concentrations have been associated with insulin resistance and other risk factors for cardiovascular disease .
METHODS	We present 1-year data from an ongoing 5-year trial in 511 individuals with impaired fasting glucose ( IFG ) and/or impaired glucose tolerance ( IGT ) randomly assigned to 20,000 IU/week vitamin D3 or placebo .
METHODS	An oral glucose tolerance test was performed at baseline and after 1 year .
RESULTS	Mean baseline serum 25 ( OH ) D was 59.9 nmol/L and 61.1 nmol/L in the vitamin D and placebo groups , respectively , and increased by 45.8 nmol/L and 3.4 nmol/L , respectively .
RESULTS	With adjustment for baseline concentrations , no differences in measures of glucose metabolism , insulin secretion or sensitivity , blood pressure , or hs-CRP were found after 1 year .
RESULTS	There was a slight , but significant decrease in total and LDL cholesterol in the vitamin D group compared with the placebo group , but as there was also a decrease in HDL cholesterol , the change in the total/HDL cholesterol ratio did not differ significantly .
RESULTS	Only analyzing subjects with 25 ( OH ) D < 50 nmol/L did not change the results .
CONCLUSIONS	This study shows that vitamin D supplementation does not improve glycemic indices , blood pressure , or lipid status in subjects with IFG and/or IGT .

###24499497
OBJECTIVE	Faecal incontinence affects up to 8 % of adults .
OBJECTIVE	Associated social isolation and subsequent depression can have devastating effects on quality of life ( QoL ) .
OBJECTIVE	Faecal incontinence is an underreported health problem as the social isolation and stigma that patients experience makes it difficult for sufferers to discuss their condition with a physician .
OBJECTIVE	There have been few well-designed , placebo-controlled clinical trials of treatment for faecal incontinence and little clinical evidence is available to inform the most appropriate management strategies .
OBJECTIVE	Libertas , a robustly designed study will investigate the efficacy and safety of NRL001 ( 1R,2S-methoxamine ) , an 1 - adrenoceptor agonist , in the treatment of faecal incontinence .
METHODS	Libertas is a multicentre , Phase II , double-blind , randomised , placebo-controlled , parallel group study .
METHODS	Patient recruitment took place across 55 study centres in Europe .
METHODS	Patients suffering with faecal incontinence were randomised into four groups ( approximately 110 each ) to receive once daily self-administered doses of NRL001 ( 5 , 7.5 or 10 mg or placebo in a suppository formulation ) for 8 weeks .
METHODS	The primary objective of Libertas is to assess the impact of once daily administration of NRL001 on the severity and frequency of incontinence episodes as assessed by the Wexner score at 4 weeks , compared with placebo .
METHODS	Secondary outcomes include measures of efficacy of NRL001 compared with placebo following 8 weeks treatment ; safety and tolerability ; evaluation of plasma pharmacokinetics ; establishment of any pharmacokinetic/pharmacodynamic relationship to adverse events ; dose-response relationship ; the efficacy of NRL001 therapy at 4 and 8 weeks assessed by the Vaizey score ; and QoL using the Faecal Incontinence Quality of Life and the EQ-5D-5L Healthcare Questionnaires following 4 and 8 weeks NRL001 therapy .
METHODS	Overall patient satisfaction with the treatment will also be evaluated .
CONCLUSIONS	This is the first randomised controlled study to investigate the efficacy and safety of a selective 1 - adrenoceptor agonist for the treatment of faecal incontinence .
CONCLUSIONS	Furthermore , this is the first time the impact of NRL001 on assessments of QoL , health outcomes and patient satisfaction will be assessed .
CONCLUSIONS	Innovative strategies were developed to meet the challenge of recruiting patients for this study , for example , media advertising , posters and mailshots as allowed by each study centre .

###24557492
OBJECTIVE	Propranolol therapy is changing the treatment paradigm for infantile hemangioma .
OBJECTIVE	This study addresses the effect of propranolol therapy on the treatment of nasal infantile hemangioma ( NIH ) , an area that often does not respond to medical therapy .
OBJECTIVE	To determine if propranolol treatment is associated with fewer invasive treatments for NIH .
METHODS	Retrospective cohort study conducted within a single pediatric institution 's multidisciplinary vascular anomaly program for patients with NIH treated between January 1 , 2003 , and December 31 , 2011 .
METHODS	Three NIH cohorts were compared : prepropranolol ( 20 in group 1 ; 2003-2009 ) , propranolol ( 25 in group 2 ; 2009-2011 ) , and nonpropranolol ( 13 in group 3 ; 2009-2011 ) treatment .
METHODS	Analysis of systemic medical , laser , or surgical therapies for NIH .
METHODS	The study plan was created to detect a change in invasive therapy for NIH .
METHODS	Data collected included presenting age , sex , affected nasal subunits , infantile hemangioma morphologic characteristics , treatment type and number , and primary treating service .
METHODS	An NIH grading system , based on nasal subunit involvement , helped quantify treatment change .
METHODS	Descriptive statistics summarized data , and a Cox proportional hazards regression model evaluated propranolol use and the likelihood of invasive treatments ( surgical excision or laser ) .
RESULTS	Of the 95 patients identified , 58 met inclusion criteria : 20 in group 1 ( mean age ,4.8 months ) , 25 in group 2 ( mean age ,4.9 months ) , and 13 in group 3 ( mean age ,4.9 months ) .
RESULTS	Nasal infantile hemangiomas involved the nasal tip subunit in 33 of 58 patients ( 56.9 % ) .
RESULTS	Eight of 13 patients ( 61.5 % ) in group 3 frequently had small NIH ( grade 1 ) .
RESULTS	Patients in group 2 were less likely to undergo any invasive treatments ( relative risk , 0.44 ; 95 % CI , 0.27-0 .73 ) , have surgical excision only ( 0.45 ; 0.15-1 .38 ) , or undergo laser treatment only ( 0.44 ; 0.27-0 .78 ) compared with those in group 1 .
RESULTS	Patients with higher-grade NIH had more medical or invasive therapy , but invasive procedures were carried out in each subgroup defined by grade .
CONCLUSIONS	Patients with isolated propranolol-treated NIH were less likely to undergo invasive treatment , but despite its implementation , the need for invasive treatment was not totally supplanted by its use .

###25592012
OBJECTIVE	A number of studies have explored the effects of dietary nitrate on human health .
OBJECTIVE	Nitrate in the blood can be recycled to nitric oxide , which is an essential mediator involved in many important biochemical mechanisms .
OBJECTIVE	Nitric oxide is also formed in the body from l-arginine by nitric oxide synthase .
OBJECTIVE	The aim of this study was to investigate whether genetic polymorphisms in endothelial nitric oxide synthase ( eNOS ) and genes involved in folate metabolism affect the concentration of serum nitrate , serum folate , and plasma total homocysteine in healthy individuals after folic acid supplementation .
METHODS	In a randomized double-blind , crossover study , participants were given either folic acid 800 g/d ( n = 52 ) or placebo ( n = 51 ) for 2 wk .
METHODS	Wash-out period was 2 wk .
METHODS	Fasting blood samples were collected , DNA was extracted by salting-out method and the polymorphisms in eNOS synthase and folate genes were genotyped by polymerase chain reaction methods .
METHODS	Measurement of serum nitrate and plasma total homocysteine ( p-tHcy ) concentration was done by high-performance liquid chromatography .
RESULTS	The concentration of serum nitrate did not change in individuals after folic acid supplements ( trial 1 ) ; however , the concentration of serum nitrate increased in the same individuals after placebo ( P = 0.01 ) ( trial 2 ) .
RESULTS	The individuals with three polymorphisms in eNOS gene had increased concentration of serum folate and decreased concentration of p-tHcy after folic acid supplementation .
RESULTS	Among the seven polymorphisms tested in folate metabolizing genes , serum nitrate concentration was significantly decreased only in DHFR del 19 gene variant .
RESULTS	A significant difference in the concentration of serum nitrate was detected among individuals with MTHFR C > T677 polymorphisms .
CONCLUSIONS	Polymorphisms in eNOS and folate genes affect the concentration of serum folate and p-tHcy but do not have any effect on the concentration of NO3 in healthy individuals after folic acid supplementation .

###25173349
OBJECTIVE	The aim of this study was to conduct a cost-utility analysis of the Education , Self-management and Upper Limb Exercise Training in People with RA ( EXTRA ) programme compared with usual care .
METHODS	A within-trial incremental cost-utility analysis was conducted with 108 participants randomized to either the EXTRA programme ( n = 52 ) or usual care ( n = 56 ) .
METHODS	A health care perspective was assumed for the primary analysis with a 36 week follow-up .
METHODS	Resource use information was collected on interventions , medication , primary and secondary care contacts , private health care and social care costs .
METHODS	Quality-adjusted life years ( QALYs ) were calculated from the EuroQol five-dimension three-level ( EQ-5D-3L ) questionnaire responses at baseline , 12 and 36 weeks .
RESULTS	Compared with usual care , total QALYs gained were higher in the EXTRA programme , leading to an increase of 0.0296 QALYs .
RESULTS	The mean National Health Service ( NHS ) costs per participant were slightly higher in the EXTRA programme ( by 82 ) , resulting in an incremental cost-effectiveness ratio of 2770 per additional QALY gained .
RESULTS	Thus the EXTRA programme was cost effective from an NHS perspective when assessed against the threshold of 20 000-30 000/QALY gained .
RESULTS	Overall , costs were lower in the EXTRA programme compared with usual care , suggesting it was the dominant treatment option from a societal perspective .
RESULTS	At a willingness-to-pay of 20 000/QALY gained , there was a 65 % probability that the EXTRA programme was the most cost-effective option .
RESULTS	These results were robust to sensitivity analyses accounting for missing data , changing the cost perspective and removing cost outliers .
CONCLUSIONS	The physiotherapist-led EXTRA programme represents a cost-effective use of resources compared with usual care and leads to lower health care costs and work absence .
BACKGROUND	International Standard Randomized Controlled Trial Number Register ; http://www.controlled-trials.com/isrctn/ ( ISRCTN14268051 ) .

###25006185
BACKGROUND	Conclusive data about cardiovascular toxicity of nonsteroidal anti-inflammatory drugs ( NSAIDs ) are sparse .
BACKGROUND	We hypothesized that regular NSAID use is associated with increased risk for cardiovascular events in postmenopausal women , and that this association is stronger with greater cyclooxygenase ( cox ) -2 when compared with cox-1 inhibition .
RESULTS	Postmenopausal women enrolled in the Women 's Health Initiative were classified as regular users or nonusers of nonaspirin NSAIDs .
RESULTS	Cox regression examined NSAID use as a time-varying covariate and its association with the primary outcome of total cardiovascular disease defined as cardiovascular death , nonfatal myocardial infarction , or nonfatal stroke .
RESULTS	Secondary analyses considered the association of selective cox-2 inhibitors ( eg , celecoxib ) , nonselective agents with cox-2 > cox-1 inhibition ( eg , naproxen ) , and nonselective agents with cox-1 > cox-2 inhibition ( eg , ibuprofen ) with the primary outcome .
RESULTS	Overall , 160 801 participants were available for analysis ( mean follow-up , 11.2 years ) .
RESULTS	Regular NSAID use at some point in time was reported by 53 142 participants .
RESULTS	Regular NSAID use was associated with an increased hazard for cardiovascular events versus no NSAID use ( hazard ratio [ HR ] , 1.10 ; 95 % confidence interval , 1.06-1 .15 ; P < 0.001 ) .
RESULTS	Selective cox-2 inhibitors were associated with a modest increased hazard for cardiovascular events ( hazard ratio , 1.13 ; 1.04-1 .23 ; P = 0.004 and celecoxib only : HR , 1.13 ; 1.01-1 .27 ; P = 0.031 ) .
RESULTS	Among aspirin users , concomitant selective cox-2 inhibitor use was no longer associated with increased hazard for cardiovascular events .
RESULTS	There was an increased risk for agents with cox-2 > cox-1 inhibition ( HR , 1.17 ; 1.10-1 .24 ; P < 0.001 and naproxen only : HR , 1.22 ; 1.12-1 .34 ; P < 0.001 ) .
RESULTS	This harmful association remained among concomitant aspirin users .
RESULTS	We did not observe a risk elevation for agents with cox-1 > cox-2 inhibition ( HR , 1.01 ; 0.95-1 .07 ; P = 0.884 and ibuprofen only : HR , 1.00 ; 0.93-1 .07 ; P = 0.996 ) .
CONCLUSIONS	Regular use of selective cox-2 inhibitors and nonselective NSAIDs with cox-2 > cox-1 inhibition showed a modestly increased hazard for cardiovascular events .
CONCLUSIONS	Nonselective agents with cox-1 > cox-2 inhibition were not associated with increased cardiovascular risk .
BACKGROUND	www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00000611 .

###25102385
OBJECTIVE	To gain insight into who is likely to benefit from activity-based therapy ( ABT ) , as assessed by secondary analysis of data obtained from a clinical trial .
METHODS	Secondary analysis of results from a randomized controlled trial with delayed treatment design .
METHODS	Outpatient program in a private , nonprofit rehabilitation hospital .
METHODS	Volunteer sample of adults ( N = 38 ; 27 men ; 11 women ; age , 22-63y ) with chronic ( 12mo postinjury ) , motor-incomplete ( American Spinal Injury Association [ ASIA ] Impairment Scale [ AIS ] grade C or D ) spinal cord injury ( SCI ) .
METHODS	A total of 9h/wk of ABT for 24 weeks including developmental sequencing ; resistance training ; repetitive , patterned motor activity ; and task-specific locomotor training .
METHODS	Algorithms were used to guide group allocation , functional electrical stimulation utilization , and locomotor training progression .
METHODS	Walking speed and endurance ( 10-meter walk test and 6-minute walk test ) and functional ambulation ( timed Up and Go test ) .
RESULTS	This secondary analysis identified likely responders to ABT on the basis of injury characteristics : AIS classification , time since injury , and initial walking ability .
RESULTS	Training effects were the most clinically significant in AIS grade D participants with injuries < 3 years in duration .
RESULTS	This information , along with information about preliminary responsiveness to therapy ( gains after 12wk ) , can help predict the degree of recovery likely from participation in an ABT program .
CONCLUSIONS	ABT has the potential to promote neurologic recovery and enhance walking ability in individuals with chronic , motor-incomplete SCI .
CONCLUSIONS	However , not everyone with goals of walking recovery will benefit .
CONCLUSIONS	Individuals with SCI should be advised of the time , effort , and resources required to undertake ABT .
CONCLUSIONS	Practitioners are encouraged to use the findings from this trial to assist prospective participants in establishing realistic expectations for recovery .

###24924587
BACKGROUND	The Atrial Fibrillation Follow-up Investigation of Rhythm Management trial showed that digoxin was associated with increased mortality in patients with atrial fibrillation .
OBJECTIVE	To assess the association of digoxin with cardiovascular ( CV ) morbidity and mortality in patients with permanent atrial fibrillation enrolled in the Dutch Rate Control Efficacy in Permanent AF : A Comparison Between Lenient Versus Strict Rate Control II trial as well as to assess the role of digoxin to achieve heart rate targets .
METHODS	The primary outcome was a composite of CV morbidity and mortality .
METHODS	Secondary outcomes included CV hospitalization and all-cause mortality or heart failure ( HF ) hospitalization .
METHODS	Of the 614 patients , 608 ( 99 % ) completed the dose-adjustment phase .
METHODS	Outcome events were analyzed from the end of the dose-adjustment phase until the end of follow-up .
METHODS	The median follow-up period was 2.9 years ( interquartile range 2.7-3 .0 years ) .
RESULTS	In total , 284 patients ( 46.7 % ) used digoxin after the dose-adjustment phase ( median dosage 0.250 mg ; interquartile range 0.0625-0 .750 mg ) .
RESULTS	These patients were more often women , previously admitted for HF , had an increased left ventricular end-systolic diameter , and more often randomized to strict rate control .
RESULTS	By using Cox proportional hazards regression analysis , the use of digoxin was not associated with an increased risk for the primary and secondary outcomes .
RESULTS	For the primary outcome , the 3-year estimated cumulative incidence was 12.9 % vs 13.4 % in the digoxin group vs the no-digoxin group ( unadjusted hazard ratio [ HR ] 0.97 ; 95 % confidence interval [ CI ] 0.62-1 .52 ) .
RESULTS	Incidence was 19.4 % vs. 19.5 % for CV hospitalization ( unadjusted HR 1.00 ; 95 % CI 0.69-1 .45 ) and 6.6 % vs. 9.9 % for all-cause mortality or HF hospitalization ( unadjusted HR 0.62 ; 95 % CI 0.34-1 .13 ) in the digoxin group vs the no-digoxin group .
CONCLUSIONS	The use of digoxin was not associated with increased morbidity and mortality .

###24630293
OBJECTIVE	Single-port access ( SPA ) laparoscopic ovarian cystectomy has been reported as a comparable procedure to conventional laparoscopy in terms of operative outcomes .
OBJECTIVE	However , whether ovarian function after SPA laparoscopic surgery is similar to conventional laparoscopy is questioned due to the limitations in moving instruments .
OBJECTIVE	The aim of this study was to evaluate whether the reduced port number affects the ovarian reserve after laparoscopic ovarian cystectomy .
METHODS	This was a randomized controlled trial of 87 women with benign ovarian cyst , who attended a university hospital and were scheduled for laparoscopic ovarian cystectomy .
METHODS	Women were randomized to SPA , two-port access ( TPA ) , or four-port access ( FPA ) laparoscopic groups .
METHODS	The primary outcome was the serum anti-Mllerian hormone ( AMH ) levels : preoperative , 1 week , 1 month and 3 months after the operation .
METHODS	Secondary outcomes were operative outcomes .
RESULTS	The mean serum AMH levels of preoperative , 1 week , 1 month and 3 months after laparoscopy were 4.42.9 , 2.72.2 , 2.31.9 , and 2.51.5 ng/mL ( in the SPA group ) , 3.62.5 , 2.32.2 , 2.63.2 , and 2.72.6 ng/mL ( in the TPA group ) , and 3.93.2 , 2.42.1 , 2.52.0 , and 2.82.2 ng/mL ( in the FPA group ) , respectively .
RESULTS	There was no statistically significant difference in the serial change of AMH levels among the SPA , TPA and FPA groups .
CONCLUSIONS	The laparoscopic ovarian cystectomy with reduced port number does not affect the serial change of ovarian reserve .
CONCLUSIONS	The SPA or TPA laparoscopy may be the alternative method to conventional laparoscopy in terms of ovarian reserve .

###24440672
OBJECTIVE	Studies reporting that budesonide is effective for the treatment of collagenous colitis have been small and differed in efficacy measures .
OBJECTIVE	Mesalamine has been proposed as a treatment option for collagenous colitis , although its efficacy has never been investigated in placebo-controlled trials .
OBJECTIVE	We performed a phase 3 , placebo-controlled , multicenter study to evaluate budesonide and mesalamine as short-term treatments for collagenous colitis .
METHODS	Patients with active collagenous colitis were randomly assigned to groups given pH-modified release oral budesonide capsules ( 9 mg budesonide once daily , Budenofalk , n = 30 ) , mesalamine granules ( 3 g mesalamine once daily , Salofalk , n = 25 ) , or placebo for 8 weeks ( n = 37 ) in a double-blind , double-dummy fashion .
METHODS	The study was conducted in 31 centers ( hospital clinics and private practices ) in Germany , Denmark , Lithuania , Spain , and the United Kingdom .
METHODS	The primary end point was clinical remission at 8 weeks defined as 3 stools per day .
METHODS	Secondary end points included clinical remission at 8 weeks , according to the Hjortswang-Criteria of disease activity , taking stool consistency into account .
RESULTS	A greater percentage of patients in the budesonide group were in clinical remission at week 8 than the placebo group ( intention-to-treat analysis , 80.0 % vs 59.5 % ; P = .072 ; per-protocol analysis , 84.8 % vs 60.6 % ; P = .046 ) .
RESULTS	Based on the Hjortswang-Criteria , 80.0 % of patients given budesonide achieved clinical remission compared with 37.8 % of patients given placebo ( P = .0006 ) ; 44.0 % of patients given mesalamine achieved clinical remission , but budesonide was superior to mesalamine ( P = .0035 ) .
RESULTS	Budesonide significantly improved stool consistency and mucosal histology , and alleviated abdominal pain .
RESULTS	The rate of adverse events did not differ among groups .
CONCLUSIONS	Oral budesonide ( 9 mg once daily ) is effective and safe for short-term treatment of collagenous colitis .
CONCLUSIONS	Short-term treatment with oral mesalamine ( 3 g once daily ) appears to be ineffective .
CONCLUSIONS	ClinicalTrials.gov number , NCT00450086 .

###25135744
BACKGROUND	In a double-blind , placebo-controlled trial ( EudraCT identifier : 2006-001795-20 ) , the standardised quality ( SQ ) house dust mite ( HDM ) sublingual immunotherapy ( SLIT ) - tablet ( ALK , Denmark ) was investigated .
METHODS	The trial included 604 subjects , 14 years , with mild-moderate HDM allergic asthma .
METHODS	Subjects were randomised 1:1:1:1 to 1 , 3 or 6 SQ-HDM or placebo once daily .
METHODS	The primary endpoint was reduction in inhaled corticosteroid ( ICS ) after one year .
METHODS	ICS reduction , asthma quality of life questionnaire ( AQLQ ) and asthma control questionnaire ( ACQ ) score was analysed post hoc in a subgroup with daily ICS use of 400-800g and ACQ score of 1-1 .5 , corresponding to partly controlled asthma ( N = 108 ) .
RESULTS	The trial met its primary endpoint .
RESULTS	In the subgroup , the difference between placebo and 6 SQ-HDM in change from baseline in daily ICS use was 327g ( p < 0.0001 ) , while it was 0.52 ( p = 0.010 ) for AQLQ .
RESULTS	The treatment effect on ICS reduction and AQLQ was increased for the subgroup versus the residual population ( ICS reduction : p < 0.001 ) ; AQLQ : p = 0.044 ) .
CONCLUSIONS	In this subgroup , including only patients with partly controlled asthma , the benefit of 1 year of treatment with SQ HDM SLIT-tablet was significantly higher than for the less severe full population , both in terms of increased asthma control and improved quality of life .

###24439982
BACKGROUND	Continuous infusion of epoprostenol is the treatment of choice in patients with pulmonary arterial hypertension in functional classes III to IV .
BACKGROUND	However , this treatment 's limitations include instability at room temperature .
BACKGROUND	A new epoprostenol formulation offers improved storage conditions and patient convenience .
METHODS	The EPITOME-2 trial was an open-label , prospective , multicenter , single-arm , phase IIIb study .
METHODS	Patients with pulmonary arterial hypertension on long-term , stable epoprostenol therapy were transitioned from epoprostenol with glycine and mannitol excipients ( Flolan ; GlaxoSmithKline , Durham , NC ) to epoprostenol with arginine and sucrose excipients ( Veletri ; Actelion Pharmaceuticals Ltd , Allschwil , Switzerland ) .
METHODS	Patients were followed up for 3 months , and dose adjustments were recorded .
METHODS	Efficacy measures included the 6-minute walk distance , hemodynamics assessed by right heart catheterization , and New York Heart Association functional class .
METHODS	Safety and tolerability of the transition were also evaluated .
METHODS	Quality of life was assessed using the Treatment Satisfaction Questionnaire for Medication .
RESULTS	Forty-two patients enrolled in the study , and 1 patient withdrew consent before treatment ; thus , 41 patients received treatment and completed the study .
RESULTS	Six patients required dose adjustments .
RESULTS	There were no clinically relevant changes from baseline to month 3 in any of the efficacy end points .
RESULTS	Adverse events were those previously described with intravenous prostacyclin therapy .
RESULTS	Treatment Satisfaction Questionnaire for Medication scores showed an improvement from baseline to month 3 in the domain of treatment convenience .
CONCLUSIONS	Transition from epoprostenol with glycine and mannitol excipients to epoprostenol with arginine and sucrose excipients did not affect treatment efficacy , raised no new safety or tolerability concerns , and provided patients with an increased sense of treatment convenience .

###25816542
BACKGROUND	Bronchopulmonary dysplasia ( BPD ) is one ofthe most significant complications among very-low-birth-weight ( VLBW ) premature infants .
BACKGROUND	Vitamin A deficiency increases the risk of BPD in VLBWinfants .
OBJECTIVE	To assess the effect of vitamin A supplementation for prevention of bronchopulmonary dysplasia in VLBW premature Thai infants .
METHODS	Randomized control trial .
METHODS	Eighty premature infants weighing < 1,500 g who received mechanical ventilation or oxygen supplementation at 24 hours ofage-admitted to Neonatal units ofSrinagarind Hospital , Khon Kaen University , Khon Kaen , Thailand-were assigned to receive either intramuscular vitaminA 5 , 000 IU3 times/week ( treatment group ) or sham procedure ( control group ) for four weeks .
METHODS	Serum vitamin A levels were measured before and after administration of the vitamin A.
RESULTS	The baseline of mean serum vitamin A levels were similar in both groups .
RESULTS	The mean serum level of vitamin A was significantly higher in the vitamin A supplemented infants than in the control infants on day 7 ( 1.41 + / - 0.48 vs. 0.92 +0.38 pmol / L , p < 0.001 ) , day 14 ( 1.48 + / - 0.90 vs. 0.96 + / - 0.36 micromol/L , p = 0.001 ) and day 28 ( 1.42 + / - 0.63 vs. 0.76 + / - 0.30 micromol/L , p < 0.001 ) after vitamin A supplementation .
RESULTS	None of the infants in the vitamin A supplemented group , compared to 5 % of the infants in the control group , had vitamin A level < 0.35 micromol/L , ( indicating severe vitamin A deficiency ) at 28 days .
RESULTS	Fewer of the premature infants in the vitamin A supplemented group required oxygen supplementation at 36 weeks postmenstrual age than in the control group albeit not statistically significant ( 22.5 vs. 35 % relative risk 0.71 ; 95 % CI 0.40 + / - 1.26 ; p = 0.21 ) .
RESULTS	Supplementation with vitamin A was also associated with a significant reduction in the duration ofintubation ( 10.8 + / - 3.1 days vitamin A supplemented group vs. 26.1 + / - 6.4 days control group , p = 0.03 ) , days on oxygen therapy ( 29.8 + / - 5.1 days vitamin A supplemented group vs. 58.2 + / - 9.1 days control group , p = 0.01 ) and length of hospital stay ( 61.9 + / - 4.2 days vitamin A supplemented group vs. 88.3 + / - 7.2 days control group , p = 0.002 ) .
CONCLUSIONS	The dose of vitamin A used in this study reduced biochemical evidence of vitamin A deficiency and , without complications , resulted in reducing duration of intubation , days of oxygen therapy , and length of hospital stay in premature infants suffering VLBW

###24704050
BACKGROUND	Iodine contrast medium ( ICM ) is considered gold standard in endovascular revascularization procedures .
BACKGROUND	However , nephrotoxicity and hypersensitivity to ICM are causes that limit its indiscriminate use .
BACKGROUND	Carbon dioxide ( CO2 ) contrast angiography has been used as an alternative in patients with formal contraindication to ICM .
BACKGROUND	However , no studies to the present date have compared in a randomized and prospective way , outcomes of revascularization procedures performed with either ICM or CO2 in patients eligible for use of both contrasts .
METHODS	Between April 2012 and April 2013 , 35 patients with peripheral arterial disease with arterial lesions classified as Trans-Atlantic Inter-Society Consensus A or B ( identified on preoperative angio computed tomography scan ) and adequate runoff underwent femoropopliteal revascularization by endovascular technique in a prospective , randomized , and controlled study .
METHODS	Patients were randomized into 2 groups : CO2 group and ICM group , according to the contrast media selected of the procedure .
METHODS	We evaluated the following outcomes in both groups : feasibility of the procedures , complications , surgical outcomes ( ankle-brachial index [ ABI ] ) , glomerular filtration rate using the Cockcroft-Gault formula , relationship between the volume of injected iodine and postoperative creatinine clearance , quality of the angiographic images obtained with CO2 , costs of the endovascular materials , and finally , cost of contrast agents .
RESULTS	We were able to perform the proposed procedures in all patients treated in this series ( ICM group and CO2 ) .
RESULTS	There were no CO2-related complications .
RESULTS	No procedures required conversion to open surgery .
RESULTS	Clinical results were satisfactory , with regression of ischemia and increased levels of ABI in both groups .
RESULTS	Variations in creatinine clearance levels showed a numerical increase in the CO2 group and a decrease in ICM group , however , with no statistically significant difference between the delta clearance in each group .
RESULTS	All CO2 arteriograms of the supragenicular arteries were graded as good or fair by both observers with high interobserver image quality concordance .
RESULTS	There was no statistical difference between endovascular material costs between the groups , but the contrast cost was significantly lower in CO2 group ( P < 0.001 ) .
CONCLUSIONS	The use of CO2 in patients with no restriction for ICM is an alternative that does not limit the feasibility of the procedures .
CONCLUSIONS	Similar outcomes were observed with CO2 when compared with the gold standard contrast ( ICM ) regarding quality of images produced , with no associated changes in creatinine clearance or hypersensitivity reactions and also allows a reduction in contrast-related costs in angioplasty procedures .

###24314348
BACKGROUND	Negative emotional states and abnormal stress reactivity are central components in drug addiction .
BACKGROUND	The brain stress system in the amygdala is thought to play a key role in the maintenance of drug dependence through negative reinforcement .
BACKGROUND	Although acute heroin administration was found to reduce anxiety , craving , and stress hormone release , whether these effects are reflected in amygdala activity has not yet been investigated .
METHODS	With a randomized , crossover , double-blind design , saline and heroin were administered to 22 heroin-dependent patients , whereas 17 healthy control subjects were included for the placebo administration only .
METHODS	We used functional magnetic resonance imaging to investigate blood oxygen level-dependent responses during fearful faces processing .
METHODS	Stress reactivity was measured by adrenocorticotropic hormone levels and by cortisol concentrations in serum and saliva 60 min after substance administration .
METHODS	Anxiety and craving levels were assessed with self-report ratings .
RESULTS	Heroin administration acutely reduced the left amygdala response to fearful faces relative to the saline injection .
RESULTS	Patients receiving saline showed a significantly higher left amygdala response to fearful faces than healthy control subjects , whose activity did not differ from patients receiving heroin .
RESULTS	The left amygdala activity correlated significantly with scores on state-anxiety and levels of adrenocorticotropic hormone , serum cortisol , and saliva cortisol among all patients and control subjects .
CONCLUSIONS	Our results show a direct relation between the acute heroin effects on stress-related emotions , stress reactivity , and left amygdala response to negative facial expressions .
CONCLUSIONS	These findings provide new insights into the mechanisms underlying negative reinforcement in heroin addiction and the effects of regular heroin substitution .

###25646406
BACKGROUND	Impairments of muscle function and strength in patients with primary hyperparathyroidism ( PHPT ) are rarely addressed , although decreased muscle function may contribute to increased fracture risk .
OBJECTIVE	We aimed to assess the changes in muscle strength , muscle function , postural stability , quality of life ( QoL ) , and well-being during treatment with vitamin D or placebo before and after parathyroidectomy ( PTX ) in PHPT patients .
METHODS	A randomized placebo-controlled trial .
METHODS	We included 46 PHPT patients , mean age 58 ( range 29-77 ) years and 35 ( 76 % ) were women .
METHODS	Daily treatment with 70g ( 2800IU ) cholecalciferol or placebo for 52 weeks .
METHODS	Treatment was administered 26 weeks before PTX and continued for 26 weeks after PTX .
METHODS	Changes in QoL and measures of muscle strength and function .
RESULTS	Preoperatively , 25-hydroxyvitamin D ( 25OHD ) increased significantly ( 50-94nmol / l ) compared with placebo ( 57-52nmol / l ) .
RESULTS	We did not measure any beneficial effects of supplementation with vitamin D compared with placebo regarding well-being , QoL , postural stability , muscle strength , or function .
RESULTS	In all patients , we measured marked improvements in QoL , well-being ( P < 0.01 ) , muscle strength in the knee flexion and extension ( P < 0.001 ) , and muscle function tests ( P < 0.01 ) after surgical cure .
RESULTS	Postural stability improved during standing with eyes closed ( P < 0.05 ) , but decreased with eyes open ( P < 0.05 ) .
CONCLUSIONS	Patients with PHPT and 25OHD levels around 50nmol/l did not benefit from vitamin D supplementation concerning muscle strength , muscle function , postural stability , well-being , or QoL .
CONCLUSIONS	Independent of preoperative 25OHD levels , PTX improved these parameters .

###25844619
BACKGROUND	It has been assumed that the increase in urine calcium ( Ca ) that accompanies an increase in dietary protein was due to increased bone resorption .
BACKGROUND	However , studies using stable Ca isotopes have found that dietary protein increases Ca absorption without increasing bone resorption .
OBJECTIVE	The objective of the study was to investigate the impact of a moderately high protein diet on bone mineral density ( BMD ) .
METHODS	This was a randomized , double-blind , placebo-controlled trial of protein supplementation daily for 18 months .
METHODS	The study was conducted at two institutional research centers .
METHODS	Two hundred eight older women and men with a body mass index between 19 and 32 kg/m ( 2 ) and a self-reported protein intake between 0.6 and 1.0 g/kg participated in the study .
METHODS	Subjects were asked to incorporate either a 45-g whey protein or isocaloric maltodextrin supplement into their usual diet for 18 months .
METHODS	BMD by dual-energy x-ray absorptiometry , body composition , and markers of skeletal and mineral metabolism were measured at baseline and at 9 and 18 months .
RESULTS	There were no significant differences between groups for changes in L-spine BMD ( primary outcome ) or the other skeletal sites of interest .
RESULTS	Truncal lean mass was significantly higher in the protein group at 18 months ( P = .048 ) .
RESULTS	C-terminal telopeptide ( P = .0414 ) , IGF-1 ( P = .0054 ) , and urinary urea ( P < .001 ) were also higher in the protein group at the end of the study period .
RESULTS	There was no difference in estimated glomerular filtration rate at 18 months .
CONCLUSIONS	Our data suggest that protein supplementation above the recommended dietary allowance ( 0.8 g/kg ) may preserve fat-free mass without adversely affecting skeletal health or renal function in healthy older adults .

###26181088
OBJECTIVE	To assess whether add-back therapy with norethindrone acetate or norethindrone acetate plus conjugated equine estrogens is superior to maintain bone health in adolescents and young women using gonadotropin-releasing hormone agonists for endometriosis .
OBJECTIVE	Gonadotropin-releasing hormone agonists are associated with deleterious effects on bone .
OBJECTIVE	Hormonal add-back may mitigate these effects .
METHODS	Adolescents and young women ( n = 51 ) received a random , double-blind assignment to add-back with norethindrone acetate ( 5 mg/day ) plus conjugated equine estrogens ( 0.625 mg/day ) or norethindrone acetate plus placebo for 12 months .
METHODS	Body composition , bone mineral content , and bone mineral density ( BMD ) were obtained by dual-energy X-ray absorptiometry every 6 months .
METHODS	Quality-of-life measures were collected every 3 months .
METHODS	Intention-to-treat comparison of outcomes was conducted by repeated-measures analysis of variance .
RESULTS	Thirty-four adolescents and young women completed the trial ; dropouts did not differ from those who completed the trial .
RESULTS	Bone mineral density was normal at baseline .
RESULTS	At 12 months , total body bone mineral content and BMD had increased in the norethindrone acetate plus conjugated equine estrogens group ( bone mineral content +37 g , P < .001 and BMD +0.012 g/cm , P = .05 ) , but not in those receiving norethindrone acetate plus placebo ( bone mineral content P = .19 and BMD P = .95 ) .
RESULTS	Lean mass increased only in those receiving conjugated equine estrogens ( +1.4 kg , P = .001 ) .
RESULTS	Improvements in physical functioning domains of quality-of-life assessments were greater with norethindrone acetate plus conjugated equine estrogens ( P = .005 ) .
RESULTS	No differences were seen at the hip or lumbar spine by dual-energy X-ray absorptiometry .
RESULTS	No significant adverse events occurred .
CONCLUSIONS	Hormonal add-back successfully preserved bone health and improved quality of life for adolescents and young women with endometriosis during 12 months of gonadotropin-releasing hormone agonist therapy .
CONCLUSIONS	Combination norethindrone acetate plus conjugated equine estrogens add-back appears to be more effective for increasing total body bone mineral content , areal BMD , and lean mass than norethindrone acetate monotherapy .
BACKGROUND	ClinicalTrials.gov ; www.clinicaltrials.gov , NCT00474851 .
METHODS	I.

###25410412
BACKGROUND	Summarizes the frequency , type , and context of sexual assault in a large sample of first-year university women at three Canadian universities .
METHODS	As part of a randomized controlled trial assessing the efficacy of a sexual assault resistance education program , baseline data were collected from women between ages of 17 and 24 using computerized surveys .
METHODS	Participants ' experience with sexual victimization since the age of 14 years was assessed using the Sexual Experiences Survey -- Short Form Victimization ( SES-SFV ) .
RESULTS	Among 899 first-year university women ( mean age = 18.5 years ) , 58.7 % ( 95 % CI : 55.4 % , 62.0 % ) had experienced one or more forms of victimization since the age of 14 years , 35.0 % ( 95 % CI : 31.9 % , 38.3 % ) had experienced at least one completed or attempted rape , and 23.5 % ( 95 % CI : 20.7 % , 26.4 % ) had been raped .
RESULTS	Among the 211 rape victims , 46.4 % ( 95 % CI : 39.7 % , 53.2 % ) had experienced more than one type of assault ( oral , vaginal , anal ) in a single incident or across multiple incidents .
RESULTS	More than three-quarters ( 79.6 % ; 95 % CI : 74.2 % , 85.1 % ) of the rapes occurred while women were incapacitated by alcohol or drugs .
RESULTS	One-third ( 33.3 % ) of women had previous self-defence training , but few ( 4.0 % ) had previous sexual assault education .
CONCLUSIONS	Findings from the first large Canadian study of university women since the 1990s indicate that a large proportion of women arrive on campuses with histories of sexual victimization , and they are generally unprepared for the perpetrators they may face during their academic years .
CONCLUSIONS	There is an urgent need for effective rape prevention programs on university campuses .
BACKGROUND	ClinicalTrials.gov NCT01338428 .
BACKGROUND	Registered 13 April 2011 .

###25631957
BACKGROUND	Non-response bias is a major problem for the validity of survey answers .
BACKGROUND	Analyses of reasons for non-response in surveys with nursing home residents ( NHR ) are scarce .
OBJECTIVE	The aim of this study was to develop reliable and valid categories which represent reasons for non-response in nursing homes using the `` Prozessmodell induktiver Kategorienbildung '' following Mayring ( 2010 ) .
OBJECTIVE	Furthermore , characteristics of unit non-responder and responder were compared .
RESULTS	Forming of categories of reasons for non-response was conducted with 522 NHR , longitudinally .
RESULTS	Four major categories were identified ( general refusal , health reasons , accessibility , excessive demand ) and further 17 subcategories .
RESULTS	Unit-non-responder and responder did not differ in age and sex ; however follow-up non-responder showed differences in marital status , training qualification , and cognitive status .
CONCLUSIONS	The presented scheme of categories can be used to assess reasons for non-response in nursing homes .
CONCLUSIONS	Standardised assessment of reasons for non-response may contribute to higher response rates in this setting .

###25381202
OBJECTIVE	Many patients with quiescent Crohn 's disease are maintained on long-term treatment with azathioprine ( AZA ) , but controlled data are limited .
OBJECTIVE	We aimed to evaluate the efficacy of AZA therapy for more than 4 years to maintain clinical remission .
METHODS	We performed a randomized double-blind placebo-controlled AZA withdrawal trial with a follow-up period of 24 months .
METHODS	Patients had to have continuous AZA therapy 4 years without exacerbation of disease during the 12 months before enrollment , and a Crohn 's disease activity index < 150 at baseline .
METHODS	Patients were randomized to continue on AZA or switch to placebo .
METHODS	The primary endpoint was time to clinical relapse during follow-up .
RESULTS	After inclusion of 52 patients , the trial was stopped prematurely due to slow recruitment .
RESULTS	During the 2-year follow-up , clinical relapse occurred in 4 of 26 ( 15 % ) patients on continued AZA and in 8 of 26 ( 31 % ) patients on placebo .
RESULTS	Time to clinical relapse averaged 22.3 months ( 95 % CI 20.6-24 .0 ) on AZA and 19.2 months ( 95 % CI 16.4-22 .1 ) on placebo ( p = 0.20 ) .
RESULTS	According to life-table analysis , the proportion of patients in remission after 12 and 24 months was 96 4 and 86 7 % in patients receiving AZA versus 76 8 and 68 9 % in patients receiving placebo ( month 12 , p = 0.035 ; month 24 , p = 0.30 ) .
RESULTS	A higher AZA dose at enrollment was an independent predictor for relapse ( p < 0.05 ) .
CONCLUSIONS	AZA withdrawal resulted in a significantly increased relapse risk after 1 year and a nonstatistically significant trend for relapse after 2 years .
CONCLUSIONS	Our results are in line with previous observations .

###24345793
OBJECTIVE	Suboptimal availability of circulating thyroid hormones may contribute to the high rate of treatment failures in bipolar disorder .
OBJECTIVE	This study tested the efficacy of adjunctive treatment with supraphysiologic doses of levothyroxine in patients with bipolar depression and the hypothesis that women would display a better outcome compared to men .
METHODS	The aims of this multicenter , 6-week , double-blind , randomized , placebo-controlled fixed-dose ( 300 g/d ) trial conducted from 2004 to 2009 were to assess efficacy and tolerability of levothyroxine adjunctive to continuing treatment with mood stabilizer and/or antidepressant medication for patients with bipolar I or II disorder , currently depressed ( DSM-IV ) , and to investigate gender differences in treatment response .
METHODS	The primary efficacy variable was mean change in Hamilton Depression Rating Scale ( HDRS ) score .
RESULTS	Of 74 patients enrolled in the study , 62 ( 35 with bipolar I ; mean age = 44.9 years ) were randomized .
RESULTS	Mean change in HDRS score from randomization to week 6 was larger in the levothyroxine group compared to the placebo group , with a 2.7-point difference ( decline of -7.8 [ 38.3 % ] vs -5.1 [ 25.5 % ] ; last-observation-carried-forward analysis ) .
RESULTS	The course of HDRS scores over time from randomization to week 6 was significantly different between groups at week 4 ( P = .046 ) but not at the end of the placebo-controlled phase ( P = .198 ) .
RESULTS	The secondary analysis of women ( n = 32 ) revealed a significant difference between groups in mean change in HDRS score ( -16.6 % placebo vs -42.4 % levothyroxine , P = .018 ) .
RESULTS	A mixed-effects model for repeated-measures analysis showed a significant between-group difference in HDRS score ( 6.8 , P = .012 ) for women .
RESULTS	High thyroid-stimulating hormone levels , indicating suboptimal levels of circulating thyroid hormones , were predictive for positive treatment outcome in women treated with levothyroxine in a linear regression model ( F3 = 3.47 ; P = .05 ) .
CONCLUSIONS	This trial demonstrated that patients treated with levothyroxine did numerically better than those treated with placebo ; however , the study failed to detect a statistically significant difference between the 2 groups in the primary outcome measure due to a high placebo response rate .
CONCLUSIONS	Previous findings that women show better improvement in depression scores with levothyroxine compared to men were confirmed .
BACKGROUND	ClinicalTrials.gov identifier : NCT01528839 .

###25324220
BACKGROUND	Exercise training has been demonstrated to enhance physical function and to have a protective effect against functional limitations and disability in older adults .
OBJECTIVE	The objective of this study was to determine whether the effects of a home-based , DVD-delivered exercise intervention on functional performance and limitations were maintained 6-month postintervention termination .
METHODS	Follow-up assessments of functional performance and limitations were conducted in a sample of community-dwelling older adults ( N = 237 ) who participated in a 6-month randomized controlled exercise trial .
METHODS	Participants were initially randomized to a DVD-delivered exercise intervention or an attentional control condition .
METHODS	The Short Physical Performance Battery , measures of flexibility and strength , and functional limitations were assessed immediately before and after the intervention and then again 6 months later .
METHODS	Analyses of covariance were conducted to examine changes in physical function between the two conditions at the end of the intervention to 6-month follow-up .
RESULTS	There were statistically significant adjusted group differences in the Short Physical Performance Battery ( ( 2 ) = 0.03 , p = .01 ) , upper-body strength ( ( 2 ) = 0.03 , p = .005 ) , and lower-body flexibility ( ( 2 ) = 0.02 , p = .05 ) , indicating that gains brought about by the intervention were maintained 6 months later .
CONCLUSIONS	A DVD-delivered exercise program specifically designed to target elements of functional fitness in older adults can produce clinically meaningful gains in physical function that are maintained beyond intervention cessation .

###24608196
BACKGROUND	NEPA is a novel oral fixed-dose combination of netupitant ( NETU ) , a new highly selective neurokinin-1 ( NK1 ) receptor antagonist ( RA ) and palonosetron ( PALO ) , a pharmacologically and clinically distinct 5-hydroxytryptamine type 3 ( 5-HT3 ) RA .
BACKGROUND	This study was designed to determine the appropriate clinical dose of NETU to combine with PALO for evaluation in the phase 3 NEPA program .
METHODS	This randomized , double-blind , parallel group study in 694 chemotherapy nave patients undergoing cisplatin-based chemotherapy for solid tumors compared three different oral doses of NETU ( 100 , 200 , and 300 mg ) + PALO 0.50 mg with oral PALO 0.50 mg , all given on day 1 .
METHODS	A standard 3-day aprepitant ( APR ) + IV ondansetron ( OND ) 32 mg regimen was included as an exploratory arm .
METHODS	All patients received oral dexamethasone on days 1-4 .
METHODS	The primary efficacy endpoint was complete response ( CR : no emesis , no rescue medication ) during the overall ( 0-120 h ) phase .
RESULTS	All NEPA doses showed superior overall CR rates compared with PALO ( 87.4 % , 87.6 % , and 89.6 % for NEPA100 , NEPA200 , and NEPA300 , respectively versus 76.5 % PALO ; P < 0.050 ) with the highest NEPA300 dose studied showing an incremental benefit over lower NEPA doses for all efficacy endpoints .
RESULTS	NEPA300 was significantly more effective than PALO and numerically better than APR + OND for all secondary efficacy endpoints of no emesis , no significant nausea , and complete protection ( CR plus no significant nausea ) rates during the acute ( 0-24 h ) , delayed ( 25-120 h ) , and overall phases .
RESULTS	Adverse events were comparable across groups with no dose response .
RESULTS	The percent of patients developing electrocardiogram changes was also comparable .
CONCLUSIONS	Each NEPA dose provided superior prevention of chemotherapy-induced nausea and vomiting ( CINV ) compared with PALO following highly emetogenic chemotherapy ; however , NEPA300 was the best dose studied , with an advantage over lower doses for all efficacy endpoints .
CONCLUSIONS	The combination of NETU and PALO was well tolerated with a similar safety profile to PALO and APR + OND .

###25140909
BACKGROUND	GSK1265744 ( 744 ) is an HIV-1 integrase inhibitor in clinical development as a long-acting ( LA ) injectable formulation .
BACKGROUND	This study evaluated plasma and tissue pharmacokinetics after single-dose administration of 744 LA administered by intramuscular ( IM ) or subcutaneous injections .
METHODS	This was a phase I , open-label , 9-cohort , parallel study of 744 in healthy subjects .
METHODS	744 was administered as a 200 mg/mL nanosuspension at doses of 100-800 mg IM and 100-400 mg subcutaneous .
RESULTS	Eight ( 6 active and 2 placebo ) male and female subjects participated in each of the first 7 cohorts .
RESULTS	All 8 subjects , 4 males and 4 females , received active 744 LA in cohorts 8 and 9 and underwent rectal and cervicovaginal tissue sampling , respectively .
RESULTS	Plasma pharmacokinetic sampling was performed for a minimum of 12 weeks or until 744 concentrations were 0.1 g/mL .
RESULTS	Rectal and cervicovaginal tissue biopsies were performed at weeks 2 and 8 ( cohort 8 ) and weeks 4 and 12 ( cohort 9 ) .
RESULTS	744 LA was generally safe and well tolerated after single injections .
RESULTS	A majority of subjects reported injection site reactions , all graded as mild in intensity .
RESULTS	Plasma concentration-time profiles were prolonged with measureable concentrations up to 52 weeks after dosing .
RESULTS	744 LA 800 mg IM achieved mean concentrations above protein adjusted-IC90 for approximately 16 weeks .
RESULTS	Rectal and cervicovaginal tissue concentrations ranged from < 8 % to 28 % of corresponding plasma concentrations .
CONCLUSIONS	These data suggest 744 LA injection has potential application as a monthly or less frequent HIV treatment or prevention agent .

###24517212
BACKGROUND	The aim of this study was to investigate patient reported outcomes ( PROs ) of functional ability and health related quality of life ( HRQoL ) in patients with early ( rheumatoid ) arthritis during one year of remission steered treatment .
METHODS	In this study , 610 patients with early rheumatoid arthritis ( RA ) or undifferentiated arthritis ( UA ) were treated with methotrexate ( MTX ) and tapered high dose of prednisone .
METHODS	Patients in early remission ( Disease Activity Score ( DAS ) < 1.6 after 4 months ) tapered prednisone to zero and when in persistent remission , also tapered MTX .
METHODS	Patients not in early remission were randomized to either MTX + hydroxychloroquine + sulphasalazine + prednisone ( arm 1 ) or to MTX + adalimumab ( arm 2 ) .
METHODS	Every 4 months , patients filled out the Health Assessment Questionnaire ( HAQ ) and the McMaster Toronto Arthritis Patient Preference Questionnaire ( MACTAR ) , the Short Form 36 ( SF-36 ) and visual analogue scales ( VAS ) .
METHODS	Change scores were compared between treatment groups .
METHODS	The association with achieving remission was analyzed using linear mixed models .
RESULTS	During year 1 , patients who achieved early remission had the most improvement in PROs with scores comparable to the general population .
RESULTS	Patients in the randomization arms showed less improvement .
RESULTS	Scores were comparable between the arms .
RESULTS	There was a significant association between achieving remission and scores of HAQ , MACTAR and physical HRQoL .
CONCLUSIONS	In early arthritis , PROs of functional ability and HRQoL after one year of remission steered treatment reach normal values in patients who achieved early remission .
CONCLUSIONS	In patients not in early remission , who were randomized to two strategy arms , PROs improved less , with similar scores in both treatment arms .
BACKGROUND	ISRCTN11916566 and EudraCT2006-006186-16 .

###24596459
BACKGROUND	Addition of a second bronchodilator from a different pharmacological class may benefit patients with moderate-to-severe chronic obstructive pulmonary disease ( COPD ) whose symptoms are insufficiently controlled by bronchodilator monotherapy .
BACKGROUND	GLOW6 evaluated the efficacy and safety of once-daily coadministration of the long-acting 2-agonist indacaterol ( IND ) and the long-acting muscarinic antagonist glycopyrronium ( GLY ) versus IND alone in patients with moderate-to-severe COPD .
METHODS	In this randomized , double-blind , parallel group , placebo-controlled , 12-week study , patients were randomized 1:1 to IND 150 g and GLY 50 g daily ( IND + GLY ) or IND 150 g daily and placebo ( IND + PBO ) ( all delivered via separate Breezhaler devices ) .
METHODS	The primary objective was to demonstrate the superiority of IND + GLY versus IND + PBO for trough forced expiratory volume in 1 second ( FEV1 ) at week 12 .
METHODS	Other end points included trough FEV1 at day 1 , FEV1 area under the curve from 30 minutes to 4 hours ( AUC30min-4h ) , peak FEV1 , inspiratory capacity and trough forced vital capacity ( FVC ) at day 1 and week 12 , and transition dyspnea index ( TDI ) focal score , COPD symptoms , and rescue medication use over 12 weeks .
RESULTS	A total of 449 patients were randomized ( IND + GLY , 226 ; IND + PBO , 223 ) ; 94 % completed the study .
RESULTS	On day 1 and at week 12 , IND + GLY significantly improved trough FEV1 versus IND + PBO , with treatment differences of 74 mL ( 95 % CI 46-101 mL ) and 64 mL ( 95 % CI 28-99 mL ) , respectively ( both P < 0.001 ) .
RESULTS	IND + GLY significantly improved postdose peak FEV1 , FEV1 AUC30min-4h , and trough FVC at day 1 and week 12 versus IND + PBO ( all P < 0.01 ) .
RESULTS	TDI focal score and COPD symptoms ( percentage of days able to perform usual daily activities and change from baseline in mean daytime respiratory score ) were significantly improved with IND + GLY versus IND + PBO ( P < 0.05 ) .
RESULTS	The incidence of adverse events was similar for the two treatment groups .
CONCLUSIONS	In patients with moderate-to-severe COPD , once-daily coadministration of IND and GLY provides significant and sustained improvement in bronchodilation versus IND alone from day 1 , with significant improvements in patient-centered outcomes .

###24675287
BACKGROUND	The DBCG 77C trial compared one year of tamoxifen in postmenopausal , steroid-receptor unknown , high-risk breast cancer patients to no adjuvant systemic therapy .
BACKGROUND	After a potential follow-up of 30years we report overall efficacy of the study and results according to subtypes subsequently assessed by immunohistochemistry and fluorescent in situ hybridisation ( FISH ) .
METHODS	Between 1977 and 1982 , 1716 postmenopausal patients with tumours larger than 5cm or positive axillary nodes were randomly assigned to no systemic therapy or tamoxifen 30mg daily for one year .
METHODS	Archival tumour tissue from 1515 patients was analysed and the hormone receptor positive ( estrogen receptor ( ER ) and/or progesterone receptor ( PR ) ) cancers were defined as luminal A if Ki67 low and HER2-negative ; as luminal B if Ki67 high or HER2-positive ; and otherwise as non-luminal-HER2 positive or triple negative .
RESULTS	In the intent-to-treat ( ITT ) population one year of tamoxifen improved the disease-free-survival ( DFS ) ( hazard ratio ( HR ) = 0.87 ; 95 % confidence interval ( CI ) 0.77-0 .98 ) , the Breast Cancer Recurrence Rate ( BCRR ) ( HR = 0.79 ; 0.69-0 .90 ) and reduced the breast-cancer-specific-mortality ( BCM ) ( HR = 0.83 ; 0.73-0 .93 ) .
RESULTS	BCRR were improved significantly by tamoxifen in luminal A ( HR = 0.66 ; 0.53-0 .84 ) and luminal B/HER2 - ( HR = 0.54 ; 0.39-0 .74 ) but not in the other subsets , and with similar results for BCM with 30years follow-up .
CONCLUSIONS	One year of treatment with tamoxifen significantly improves BCRR and BCM in postmenopausal patients with ER positive breast cancers .
CONCLUSIONS	The relative benefit from tamoxifen was not significantly different in luminal A and B subtypes .
BACKGROUND	The Danish Breast Cancer Cooperative Group ( DBCG ) prepared the original protocol ( DBCG 77C ) and was the sponsor of the study .
BACKGROUND	Funding was not provided to the participating departments .
BACKGROUND	The biomarker study was supported by grants from the Clinical Institute , Odense University .

###24962353
BACKGROUND	For patients with advanced cancer , visits to the emergency department ( ED ) are common .
BACKGROUND	Such patients present to the ED with a specific profile of palliative care needs , including burdensome symptoms such as pain , dyspnea , or vomiting that can not be controlled in other settings and a lack of well-defined goals of care .
BACKGROUND	The goals of this study are : i ) to test the feasibility of recruiting , enrolling , and randomizing patients with serious illness in the ED ; and ii ) to evaluate the impact of ED-initiated palliative care on health care utilization , quality of life , and survival .
METHODS	This is a protocol for a single center parallel , two-arm randomized controlled trial in ED patients with metastatic solid tumors comparing ED-initiated palliative care referral to a control group receiving usual care .
METHODS	We plan to enroll 125 to 150 ED-advanced cancer patients at Mount Sinai Hospital in New York , USA , who meet the following criteria : i ) pass a brief cognitive screen ; ii ) speak fluent English or Spanish ; and iii ) have never been seen by palliative care .
METHODS	We will use balanced block randomization in groups of 50 to assign patients to the intervention or control group after completion of a baseline questionnaire .
METHODS	All research staff performing assessment or analysis will be blinded to patient assignment .
METHODS	We will measure the impact of the palliative care intervention on the following outcomes : i ) timing and rate of palliative care consultation ; ii ) quality of life and depression at 12 weeks , measured using the FACT-G and PHQ-9 ; iii ) health care utilization ; and iv ) length of survival .
METHODS	The primary analysis will be based on intention-to-treat .
CONCLUSIONS	This pilot randomized controlled trial will test the feasibility of recruiting , enrolling , and randomizing patients with advanced cancer in the ED , and provide a preliminary estimate of the impact of palliative care referral on health care utilization , quality of life , and survival .
BACKGROUND	Clinical Trials.gov identifier : NCT01358110 ( Entered 5/19/2011 ) .

###25155203
BACKGROUND	The objective of this randomised trial was to compare surgical rotator cuff repair to simple decompression by acromioplasty and biceps tenotomy in patients older than 60 years of age with a mean follow-up of 4 years .
OBJECTIVE	Tendon repair produces better functional outcomes than simple decompression and prevents progression towards cuff tear arthropathy in the longer term .
METHODS	Of 130 initially included patients older than 60 years of age and having rotator cuff tears deemed amenable to surgical repair , 103 ( 79 % ) were evaluated after a mean of 4 years .
METHODS	These patients had been randomly allocated to acromioplasty and tenotomy ( AT group , n = 49 ) or to acromioplasty , tenotomy , and tendon suture ( CR group , n = 54 ) .
METHODS	The tear was distal in 41 patients , intermediate in 40 , and retracted in 22 .
METHODS	At last follow-up , the evaluation included the clinical Constant 's Score , radiographs and , in the CR group , ultrasonography .
RESULTS	The complication rate was 4 % .
RESULTS	The mean Constant Score was 44 preoperatively ; values after 4 years were 76 overall ( P = 0.01 ) , 78 in the CR group , and 73 in the AT group ( P = 0.01 ) .
RESULTS	The tendon-healing rate as assessed using ultrasonography was 63 % .
RESULTS	The Constant Score was significantly better when tendon healing was achieved ( 82/73 , P < 0.001 ) .
RESULTS	In the AT group , the acromio-humeral distance was significantly shorter ( 6.9 mm/7 .8 mm , P = 0.03 ) and eccentric humeral head position was more common ( 44 % / 26 % , P = 0.01 ) .
CONCLUSIONS	Arthroscopic rotator cuff repair provides better functional outcomes than does simple decompression in patients older than 60 years and prevents cuff tear arthropathy with eccentric humeral head position in the medium term .
CONCLUSIONS	Tendon healing is the main determinant of outcomes after rotator cuff repair .
METHODS	II , randomised trial .

###25494702
BACKGROUND	Medication regimens for asthma are particularly vulnerable to adherence problems because of the requirement for long-term use and periods of symptom remission experienced by patients .
BACKGROUND	Pharmacists are suited to impact medication adherence given their training , skills , and frequent contact with patients .
BACKGROUND	The Empowering pharmacists in asthma management through interactive SMS ( EmPhAsIS ) trial involves an intervention leveraging mobile health ( mHealth ) technology to support community pharmacy practice with the hypothesis of improved medication adherence in asthma .
METHODS	This study is a pragmatic pharmacy-based , cluster , randomized controlled trial with 12months of intervention delivery and follow-up .
METHODS	Pharmacies ( the clusters ) will be randomized at a 1:1 ratio to provide intervention or usual care .
METHODS	The EmPhAsIS intervention consists of patient asthma education , short message service ( SMS ) - based monthly assessment of adherence , and follow-up of non-adherent individuals by community pharmacists .
METHODS	There are no inclusion or exclusion criteria for pharmacies .
METHODS	Patients are eligible if they : are 14years of age or older , fill a prescription for inhaled corticosteroid ( either monotherapy or in a combination inhaler with long-acting beta-agonists ) , have been diagnosed with asthma , possess a mobile phone with SMS capabilities , and have no communication difficulties such as inability to communicate in English , or significant impairment in vision , hearing , or speech .
METHODS	The primary outcome is adherence to inhaled corticosteroids ascertained by the medication possession ratio , the ratio of the days of medication supplied to days in a given time interval .
METHODS	This study will also evaluate secondary outcomes including : asthma control , asthma-related quality of life , asthma-related hospital admissions , and use of reliever medications during the follow-up period .
METHODS	A nested economic evaluation using a probabilistic decision-analytic model will be used to perform a cost-effectiveness analysis from the societal perspective of the intervention compared with usual care over a 10-year time horizon .
CONCLUSIONS	Considering the prevalence of asthma , the extent of the non-adherence problem in this disease , and the availability of effective treatments , there is a tremendous potential to reduce the burden of asthma through improving adherence .
CONCLUSIONS	This is the first study of an intervention based on mobile communication technology involving community pharmacists in asthma management .
BACKGROUND	ClinicalTrials.gov identifier : NCT02170883 ; date of registration : 19 June 2014 .

###24604606
OBJECTIVE	To determine if aspheric intraocular lens ( IOL ) implantation produces the same degree of postoperative ocular aberration and contrast sensitivity as spherical IOL implantation .
METHODS	In this randomized prospective comparative study , 60 eyes of 30 cataract surgery patients were randomly assigned to receive a spherical IOL ( Rayner 620H ) in one eye and an aspheric IOL ( Rayner 920H ) in the contralateral eye .
METHODS	All patients were examined at 1 month postoperatively .
METHODS	Primary outcomes of contrast sensitivity and ocular wavefront higher order aberrations ( HOAs ) were assessed .
RESULTS	Aspheric IOLs ( median total HOAs 0.26 root mean square [ RMS ] ; range 0.13-0 .82 RMS ) produced significantly lower total HOAs than spherical IOLs ( median total HOAs 0.34 RMS ; range 0.18-1 .08 RMS ; p < 0.05 ) .
RESULTS	Contrast sensitivity was significantly better with aspheric IOLs ( median contrast sensitivity 1.8 log units ; range 1.35-1 .8 log units ) than with spherical IOLs ( median contrast sensitivity 1.65 log units ; range 1.35-1 .8 log units ; p < 0.05 ) .
CONCLUSIONS	When compared with a structurally ( platform and material ) similar spherical IOL ( Rayner 620H ) , aspheric IOLs ( Rayner 920H ) appear to significantly reduce HOAs and yield better levels of contrast sensitivity under photopic conditions .

###24472043
OBJECTIVE	The aim of this study was to evaluate , under farm conditions , the use of a teat sealant in addition to whole herd dry cow antibiotic therapy on the risk of clinical mastitis in dairy cattle at pasture , and to evaluate the impact of dry period length on that risk and the impact of the teat sealant on that risk .
METHODS	Dairy cows in three herds which used routine whole herd antibiotic therapy were randomly assigned to receive either treatment with an internal teat sealant ( n = 322 ) or no additional treatment ( n = 313 ) at drying-off between March and May 2010 .
METHODS	All clinical mastitis cases during the dry period and to the end of the subsequent lactation were recorded by farm staff ; factors affecting risk of clinical mastitis were then analysed using a Cox proportional hazards model .
RESULTS	Median duration of the dry period was 112 days with > 25 % of cows having a dry period > 130 days .
RESULTS	The incidence risk of mastitis during lactation for cows treated with teat sealant was 9.9 ( 95 % CI = 6.9-13 .7 ) cases per 100 cows compared with 17.9 ( 95 % CI = 13.8-22 .6 ) cases per 100 cows for cows treated with antibiotic alone .
RESULTS	The addition of a teat sealant to dry cow antibiotic therapy decreased the risk of clinical mastitis only in the first 33 days after calving ( Hazard risk 0.24 ( 95 % CI = 0.12-0 .48 ) ) .
RESULTS	Length of dry period did not significantly affect the risk of clinical mastitis , or the effect of adding teat sealant to dry cow antibiotic therapy on the risk of clinical mastitis .
CONCLUSIONS	In these herds where , based on the mastitis history , whole herd antibiotic therapy had been recommended , the use of a teat sealant significantly reduced the risk of clinical mastitis .
CONCLUSIONS	This effect was limited to the first 33 days after calving ; subsequently there was no significant effect of treatment .
CONCLUSIONS	There was no effect of dry period length on risk of clinical mastitis , nor any significant interaction with treatment .
CONCLUSIONS	Combination therapy with teat sealant and antibiotic was effective under New Zealand conditions in herds using whole herd antibiotic treatment at drying off .
CONCLUSIONS	Teat sealant reduced risk of clinical mastitis in cattle with dry periods substantially longer than 100 days , and there was no evidence that this effect changed as dry period length increased .

###25676588
OBJECTIVE	To determine the dose of triptorelin that is sufficient to maintain complete ovarian suppression in female patients with childhood-onset systemic lupus erythematosus ( SLE ) who require cyclophosphamide therapy , to determine the length of time needed to achieve ovarian suppression after initiation of triptorelin treatment , and to investigate the safety of triptorelin .
METHODS	In this randomized , double-blind , placebo-controlled , dose-escalation study , female patients ages < 21 years were randomized 4:1 to receive triptorelin ( n = 25 ) or placebo ( n = 6 ) .
METHODS	The starting doses of triptorelin were 25 , 50 , 75 , and 100 g/kg , and the dose was escalated until complete ovarian suppression was maintained .
METHODS	The primary outcome was the weight-adjusted dose of triptorelin that provided complete ovarian suppression in at least 90 % of the patients , as determined by gonadotropin-releasing hormone agonist stimulation testing .
METHODS	The secondary outcome was the period of time required to achieve ovarian suppression , as measured by unstimulated follicle-stimulating hormone and luteinizing hormone levels after the initiation of triptorelin treatment .
RESULTS	Treatment with triptorelin at a weight-adjusted dose of 120 g/kg body weight provided sustained complete ovarian suppression in 90 % of the patients .
RESULTS	After administration of the initial dose of triptorelin , 22 days were required to achieve complete ovarian suppression .
RESULTS	The rates of adverse events ( AEs ) and serious adverse events ( SAEs ) per 100 patient-months of followup were not higher in the triptorelin group compared with the placebo group ( for AEs , 189 versus 362 ; for SAEs , 2.1 versus 8.5 ) .
CONCLUSIONS	High doses of triptorelin are needed to achieve and maintain complete ovarian suppression , but such doses appear to be well tolerated in adolescent female patients with childhood-onset SLE .
CONCLUSIONS	Our data suggest that a lag time of 22 days after initiation of triptorelin treatment is required before cyclophosphamide therapy is started or continued .

###24315625
BACKGROUND	To examine the association between baseline body mass index ( BMI ) , and disease-free survival ( DFS ) and overall survival ( OS ) in a large French early-stage breast cancer population included in the UNICANCER Programme d'Action Concert Sein-01 ( PACS01 ) and PACS04 phase III randomised trials .
METHODS	After a median follow-up of 5.9 years , this report analyses 4996 patients with node-positive breast cancer , and randomly assigned to adjuvant anthracycline-based chemotherapy combined or not with taxanes .
METHODS	Univariate analyses were used to study the effects of well known prognostic factors and BMI on DFS and OS .
METHODS	BMI was obtained at baseline , before chemotherapy initiation , and obesity was defined as a BMI30kg/m ( 2 ) .
METHODS	Cox proportional hazards regression models were secondly used to assess the influence of BMI after adjusting for other factors .
METHODS	Exhaustive analysis of the dose intensity delivered was also studied for comparison between obese and non-obese patients .
RESULTS	Obese patients initially present with more advanced disease at diagnosis compared to non-obese patients .
RESULTS	By univariate analysis , obesity was moderately associated with poorer DFS ( hazard ratio ( HR ) = 1.18 [ 1.01-1 .39 ] P = 0.04 ) , but mostly with poorer OS ( HR = 1.38 [ 1.13-1 .69 ] P = 0.002 ) .
RESULTS	Delivered dose intensity of anthracyclines and taxanes was not significantly different between obese and non-obese patients .
RESULTS	After adjustment for disease characteristics , BMI had no influence either on DFS or OS .
CONCLUSIONS	This report suggests that in a French population , obesity has no impact on breast cancer prognosis when modern adjuvant chemotherapy , at the appropriate dose intensity , is delivered .

###25880946
OBJECTIVE	We demonstrated the effectiveness of an accelerated hepatitis B vaccination schedule in drug users .
METHODS	We compared the long-term effectiveness of accelerated ( 0-1-2 months ) and standard ( 0-1-6 months ) hepatitis B vaccination schedules in preventing hepatitis B virus ( HBV ) infections and anti-hepatitis B ( anti-HBs ) antibody loss during 2-year follow-up in 707 drug users ( HIV and HBV negative at enrollment and completed 3 vaccine doses ) from February 2004 to October 2009 .
RESULTS	Drug users in the accelerated schedule group had significantly lower HBV infection rates , but had a similar rate of anti-HBs antibody loss compared with the standard schedule group over 2 years of follow-up .
RESULTS	No chronic HBV infections were observed .
RESULTS	Hepatitis C positivity at enrollment and age younger than 40 years were independent risk factors for HBV infection and antibody loss , respectively .
CONCLUSIONS	An accelerated vaccination schedule was more preferable than a standard vaccination schedule in preventing HBV infections in drug users .
CONCLUSIONS	To overcome the disadvantages of a standard vaccination schedule , an accelerated vaccination schedule should be considered in drug users with low adherence .
CONCLUSIONS	Our study should be repeated in different cohorts to validate our findings and establish the role of an accelerated schedule in hepatitis B vaccination guidelines for drug users .

###24267396
BACKGROUND	Insect bite hypersensitivity ( IBH ) is a common cause of pruritus in horses , but there are few controlled studies on the efficacy of allergen-specific immunotherapy ( ASIT ) .
BACKGROUND	Atopic dermatitis and IBH can present with overlapping clinical signs ; multiple insect and environmental allergens could be indicated in these horses to achieve effective hyposensitization .
BACKGROUND	Although the success of ASIT using Culicoides spp .
BACKGROUND	whole-body extracts is controversial , there are no controlled studies published that clearly show benefit from this form of therapy .
OBJECTIVE	The objective was to evaluate the efficacy of ASIT in horses with IBH using commercially available extracts and tests .
METHODS	Twenty horses with seasonal pruritus and positive intradermal reactions to a whole Culicoides extract .
METHODS	An enzyme-linked immunosorbent assay test ( Allercept ( ) ) was used to detect concurrent allergen-specific IgE for other insects and environmental allergens .
METHODS	The ASIT was formulated by adding the relevant serologically positive allergens to the Culicoides extract .
METHODS	After randomization , 10 horses received ASIT and the rest a placebo solution .
METHODS	Clinical response was assessed every 4 months during 1 year using a clinical scoring system based on the severity of four clinical signs at 10 different body regions .
METHODS	Horses were not stabled and , to minimize dropouts , an insect repellent was used weekly in both groups .
RESULTS	Differences in clinical scores between groups were nonsignificant at any re-evaluation , while both groups improved to a similar extent , probably due to the insecticide treatment .
CONCLUSIONS	Using commercially available extracts and tests , we could not demonstrate a beneficial effect of 1 year multiple ASIT in nonstabled horses with IBH .

###24237482
BACKGROUND	Expanded access to efficacious interventions is needed for women living with human immunodeficiency virus ( WLH ) in the United States .
BACKGROUND	Availability of `` prevention with ( human immunodeficiency virus [ HIV ) ] positives '' interventions in rural/remote and low HIV prevalence areas remains limited , leaving WLH in these communities few options for receiving effective behavioral interventions such as Healthy Relationships ( HR ) .
BACKGROUND	Offering such programs via videoconferencing groups ( VGs ) may expand access .
BACKGROUND	This analysis tests the effectiveness of HR-VG ( versus wait-list control ) for reducing sexual risk behavior among WLH and explores intervention satisfaction .
METHODS	In this randomized controlled trial unprotected vaginal/anal sex occasions over the prior 3 months reported at the 6-month follow-up were compared across randomization groups through zero-inflated Poisson regression modeling , controlling for unprotected sex at baseline .
METHODS	Seventy-one WLH were randomized and completed the baseline assessment ( n = 36 intervention and n = 35 control ) ; 59 ( 83 % in each group ) had follow-up data .
RESULTS	Among those who engaged in unprotected sex at 6-month follow-up , intervention participants had approximately seven fewer unprotected occasions than control participants ( 95 % confidence interval 5.43-7 .43 ) .
RESULTS	Intervention participants reported high levels of satisfaction with HR-VG ; 84 % reported being `` very satisfied '' overall .
CONCLUSIONS	This study found promising evidence for effective dissemination of HIV risk reduction interventions via VGs .
CONCLUSIONS	Important next steps will be to determine whether VGs are effective with other subpopulations of people living with HIV ( i.e. , men and non-English speakers ) and to assess cost-effectiveness .
CONCLUSIONS	Possibilities for using VGs to expand access to other psychosocial and behavioral interventions and reduce stigma are discussed .

###24832424
OBJECTIVE	We determined the efficacy and cost-effectiveness of adding an evidence-based Internet behavioral weight loss intervention alone or combined with optional group sessions to ShapeUp Rhode Island 2011 ( SURI ) , a 3-month statewide wellness campaign .
METHODS	We randomized participants ( n = 230 ; body mass index = 34.3 6.8 kg/m ( 2 ) ; 84 % female ) to the standard SURI program ( S ) or to 1 of 2 enhanced programs : SURI plus Internet behavioral program ( SI ) or SI plus optional group sessions ( SIG ) .
METHODS	The primary outcome was weight loss at the end of the 3-month program .
RESULTS	Weight losses differed among all 3 conditions ( S : 1.1 % 0.9 % ; SI : 4.2 % 0.6 % ; SIG : 6.1 % 0.6 % ; Ps .04 ) .
RESULTS	Both SI and SIG increased the percentage of individuals who achieved a 5 % weight loss ( SI : 42 % ; SIG : 54 % ; S : 7 % ; Ps < .001 ) .
RESULTS	Cost per kilogram of weight loss was similar for S ( $ 39 ) and SI ( $ 35 ) ; both were lower than SIG ( $ 114 ) .
CONCLUSIONS	Although weight losses were greatest at the end of SURI with optional group sessions , the addition of an Internet behavioral program was the most cost-effective method to enhance weight losses .

###25055809
BACKGROUND	Individuals with major depressive disorder ( MDD ) are characterized by maladaptive responses to both positive and negative outcomes , which have been linked to localized abnormal activations in cortical and striatal brain regions .
BACKGROUND	However , the exact neural circuitry implicated in such abnormalities remains largely unexplored .
METHODS	In this study 26 unmedicated adults with MDD and 29 matched healthy controls ( HCs ) completed a monetary incentive delay task during functional magnetic resonance imaging ( fMRI ) .
METHODS	Psychophysiological interaction ( PPI ) analyses probed group differences in connectivity separately in response to positive and negative outcomes ( i.e. monetary gains and penalties ) .
RESULTS	Relative to HCs , MDD subjects displayed decreased connectivity between the caudate and dorsal anterior cingulate cortex ( dACC ) in response to monetary gains , yet increased connectivity between the caudate and a different , more rostral , dACC subregion in response to monetary penalties .
RESULTS	Moreover , exploratory analyses of 14 MDD patients who completed a 12-week , double-blind , placebo-controlled clinical trial after the baseline fMRI scans indicated that a more normative pattern of cortico-striatal connectivity pre-treatment was associated with greater improvement in symptoms 12 weeks later .
CONCLUSIONS	These results identify the caudate as a region with dissociable incentive-dependent dACC connectivity abnormalities in MDD , and provide initial evidence that cortico-striatal circuitry may play a role in MDD treatment response .
CONCLUSIONS	Given the role of cortico-striatal circuitry in encoding action-outcome contingencies , such dysregulated connectivity may relate to the prominent disruptions in goal-directed behavior that characterize MDD .

###25330161
OBJECTIVE	To assess the performance of QuantiFERON-TB Gold In-Tube ( QFT-GIT ) test for active tuberculosis ( TB ) in HIV adults , and its variation over time in patients on antiretroviral therapy ( ART ) and/or isoniazide preventive therapy ( IPT ) .
METHODS	Transversal study and cohort nested in the Temprano ANRS 12136 randomized controlled trial assessing benefits of initiating ART earlier than currently recommended by World Health Organization , with or without a 6-month IPT .
METHODS	Performance of QFT-GIT for detecting active TB at baseline in the first 50 % participants , and 12-month incidence of conversion/reversion in the first 25 % participants were assessed .
METHODS	QFT-GIT threshold for positivity was 0.35 IU/ml .
RESULTS	Among the 975 first participants ( median baseline CD4 count 383/mm3 , positive QFT-GIT test 35 % ) , 2.7 % had active TB at baseline .
RESULTS	QFT-GIT sensitivity , specificity , positive and negative predictive value for active TB were 88.0 % , 66.6 % , 6.5 % and 99.5 % .
RESULTS	For the 444 patients with a second test at 12 months , rates for conversion and reversion were 9.3 % and 14 % .
RESULTS	Reversion was more frequent in patients without ART and younger patients .
RESULTS	IPT and early ART were not associated with reversion/conversion .
CONCLUSIONS	A negative QFT-GIT could rule out active TB in HIV-infected adults not severely immunosuppressed , thus avoiding repeated TB testing and accelerating diagnosis and care for other diseases .
BACKGROUND	ClinicalTrials.gov NCT00495651 .

###25306591
BACKGROUND	The aim of the work is to study histomorphometric and histochemical properties of jaw bone loss in patients with full or partial edentulism , need to restoring their dentition integrity by dental implantation .
METHODS	Cytological studies were carried out in 83 patients , among which normal bone mass was observed in 28 patients ( 17 women and 11 men ) , osteopenia in 26 patients ( 17 women and 9 men ) , osteoporosis in 29 ( 19 women and 10 men ) patients .
METHODS	Histological examination of bone biopsies were performed in 76 patients , among which normal bone mass was observed in 22 ( 16 women and 6 men , osteopenia in 26 patients ( 17 women and 9 men ) , osteoporosis in 28 ( 19 women and 9 men ) patients .
RESULTS	Histomorphometric analysis of `` implant-bone '' contact in the entire length of the joint in patients with normal bone mass was 61.8 + / - 3.7 % , with osteopenia was 51.6 + / - 3.0 % , with osteoporosis was 46.1 + / - 2.8 % .
RESULTS	The intensity of bone remodeling in patients with normal bone mass was 2.7 + / - 0.19 , in patients with osteopenia was 2.2 + / - 0.14 , in patients with osteoporosis was 1.8 + / - 0.11 .
RESULTS	This demonstrates the significant difference between the patients with normal bone mass and osteoporotic patients .
RESULTS	The `` implant-bone '' interface in osteoporotic patients was significantly lower than in patients with normal bone mass .
CONCLUSIONS	Histomorphometric studies and quantitative histochemical analysis revealed that the decrease of bone mineral mass in patients often combined with a decrease of the `` implant surface-bone '' site contact area , with atrophy and with hypoplasia of perimplant tissues .

###24928083
BACKGROUND	Since the 1990s , fluorouracil-based adjuvant chemotherapy has significantly reduced the risk of tumour recurrence in patients with stage III colon cancer .
BACKGROUND	We aimed to assess whether the addition of cetuximab to standard adjuvant oxaliplatin , fluorouracil , and leucovorin chemotherapy ( FOLFOX4 ) in patients with stage III colon cancer improved disease-free survival ( DFS ) .
METHODS	For this open-label , randomised phase 3 study done in nine European countries , we enrolled patients through an interactive voice response system to the central randomisation centre , with a central stratified permuted block randomisation procedure .
METHODS	We randomly assigned patients with resected ( R0 ) stage III disease ( 1:1 ) to receive 12 cycles of FOLFOX4 twice a week with or without cetuximab .
METHODS	Patients were stratified by N-status ( N1 vs N2 ) , T-status ( T1-3 vs T4 ) , and obstruction or perforation status ( no obstruction and no perforation vs obstruction or perforation or both ) .
METHODS	A protocol amendment ( applied in June , 2008 , after 2096 patients had been randomly assigned to treatment-restricted enrolment to patients with tumours wild-type at codons 12 and 13 in exon 2 of the KRAS gene ( KRAS exon 2 wild-type ) .
METHODS	The primary endpoint was DFS .
METHODS	Analysis was intention to treat in all patients with KRAS exon 2 wild-type tumours .
METHODS	The study is registered at EudraCT , number 2005-003463-23 .
RESULTS	Between Dec 22 , 2005 , and Nov 5 , 2009 , 2559 patients from 340 sites in Europe were randomly assigned .
RESULTS	Of these patients , 1602 had KRAS exon 2 wild-type tumours ( intention-to-treat population ) , 791 in the FOLFOX4 plus cetuximab group and 811 in the FOLFOX4 group .
RESULTS	Median follow-up was 33 years ( IQR 32-34 ) .
RESULTS	In the experimental and control groups , DFS was similar in the intention-to-treat population ( hazard ratio [ HR ] 105 ; 95 % CI 085-129 ; p = 066 ) , and in patients with KRAS exon 2/BRAF wild-type ( n = 984 , HR 099 ; 95 % CI 076-128 ) or KRAS exon 2-mutated tumours ( n = 742 , HR 106 ; 95 % CI 082-137 ) .
RESULTS	We noted heterogeneous responses to the addition of cetuximab in preplanned subgroup analyses .
RESULTS	Grade 3 or 4 acne-like rash ( in 209 of 785 patients [ 27 % ] vs four of 805 [ < 1 % ] ) , diarrhoea ( 113 [ 14 % ] vs 70 [ 9 % ] ) , mucositis ( 63 [ 8 % ] vs 10 [ 1 % ] ) , and infusion-related reactions ( 55 [ 7 % ] vs 30 [ 4 % ] ) were more frequent in patients treated with FOLFOX4 plus cetuximab than in those patients who received FOLFOX4 alone .
CONCLUSIONS	The addition of cetuximab to FOLFOX4 did not improve DFS compared with FOLFOX4 alone in patients with KRAS exon 2 wild-type resected stage III colon cancer .
CONCLUSIONS	This trial can not conclude on the benefit of cetuximab in the studied population , but the heterogeneity of response suggests that further investigation of the role of FOLFOX4 plus cetuximab in specific patient subgroups is warranted .
BACKGROUND	Fdration Francophone de Cancrologie Digestive ( FFCD ) , Merck KGaA , and Sanofi-Aventis .

###25885913
BACKGROUND	Low back pain is highly prevalent and a significant public health burden in Western society .
BACKGROUND	Feasibility studies suggest personalised pedometer-driven walking is an acceptable and effective motivating tool in the management of chronic low back pain ( CLBP12weeks ) .
BACKGROUND	The proposed study will investigate pedometer-driven walking as a low cost , easily accessible , and sustainable means of physical activity to improve disability and clinical outcomes for people with CLBP in Saskatchewan , Canada .
METHODS	A fully-powered single-blinded randomised controlled trial will compare back care advice and education with back care advice and education followed by a 12-week pedometer-driven walking programme in adults with CLBP .
METHODS	Adults with self-reported CLBP will be recruited from the community and screened for elibility .
METHODS	Two-hundred participants will be randomly allocated to one of two intervention groups .
METHODS	All participants will receive a single back care advice and education session with a physiotherapist .
METHODS	Participants in the walking group will also receive a physiotherapist-facilitated pedometer based walking programme .
METHODS	The physiotherapist will facilitate the participant to monitor and progress the walking programme , by phone , on a weekly basis over 10weeks following two face-to-face sessions .
METHODS	Outcome measures of self-reported disability , physical activity , participants ' low back pain beliefs/perceptions , quality of life and direct/indirect cost estimates will be gathered at baseline , three months , six months , and 12months by a different physiotherapist blinded to group allocation .
METHODS	Following intervention , focus groups will be used to explore participants ' thoughts and experiences of pedometer-driven walking as a management tool for CLBP .
CONCLUSIONS	This paper describes the design of a community-based RCT to determine the effectiveness of a pedometer-driven walking programme in the management of CLBP .
BACKGROUND	United States National Institutes of Health Clinical Trails registry ( http://ClinicalTrails.gov/ ) No .
BACKGROUND	NCT02284958 .
BACKGROUND	Registered on 27 ( th ) October 2014 ) .

###25454870
BACKGROUND	This randomised , open label , phase I , immunotherapeutic study investigated the effects of interleukin ( IL ) -2 , granulocyte-macrophage colony-stimulating factor ( GM-CSF ) , recombinant human growth hormone ( rhGH ) , and therapeutic immunisation ( a Clade B DNA vaccine ) on combination antiretroviral therapy ( cART ) - treated HIV-1-infected individuals , with the objective to reverse residual T-cell dysfunction .
METHODS	Twelve HIV-1 ( + ) patients on suppressive cART with baseline CD4 T-cell counts > 400 cells/mm ( 3 ) blood were randomised into one of three groups : ( 1 ) vaccine , IL-2 , GM-CSF and rhGH ( n = 3 ) ; ( 2 ) vaccine alone ( n = 4 ) ; or ( 3 ) IL-2 , GM-CSF and rhGH ( n = 5 ) .
METHODS	Samples were collected at weeks 0 , 1 , 2 , 4 , 6 , 8 , 12 , 16 , 24 and 48 .
METHODS	Interferon ( IFN ) - , IL-2 , IL-4 and perforin ELISpot assays performed at each time point quantified functional responses to Gag p17/p24 , Nef , Rev , and Tat peptides ; and detailed T-cell immunophenotyping was undertaken by flow cytometry .
METHODS	Proviral DNA was also measured .
RESULTS	Median baseline CD4 T-cell count was 757 cells/mm ( 3 ) ( interquartile range [ IQR ] 567-886 cells/mm ( 3 ) ) , median age 48 years ( IQR 42-51 years ) , and plasma HIV-1-RNA < 50 copies/ml for all subjects .
RESULTS	Patients who received vaccine plus IL-2 , GM-CSF and rhGH ( group 1 ) showed the most marked changes .
RESULTS	Assessing mean changes from baseline to week 48 revealed significantly elevated numbers of CD4 T cells ( p = 0.0083 ) and improved CD4/CD8 T-cell ratios ( p = 0.0033 ) .
RESULTS	This was accompanied by a significant reduction in expression of CD38 on CD4 T cells ( p = 0.0194 ) , significantly increased IFN - and IL-2 production in response to Gag ( p = 0.0122 ) and elevated IFN - production in response to Tat ( p = 0.041 ) at week 48 compared to baseline .
RESULTS	Subjects in all treatment groups showed significantly reduced PD-1 expression at week 48 compared to baseline , with some reductions in proviral DNA .
CONCLUSIONS	Multifarious immunotherapeutic approaches in the context of fully suppressive cART further reduce immune activation , and improve both CD4 T-lymphocyte counts and HIV-1-specific T-cell responses ( NCT01130376 ) .

###24495641
OBJECTIVE	To investigate the analgesic and sedative effects of inhaling a mixture of nitrous oxide and oxygen on burn patient during and after dressing change .
METHODS	A total of 240 burn patients hospitalized in the Institute of Burn Research of Changhai Hospital Affiliated to the Second Military Medical University , Department of Burns of the First People 's Hospital in Zhengzhou , and Department of Burns and Plastic Surgery of General Hospital of Ningxia Medical University from October 2011 to September 2012 were enrolled in our study , and they were all in accordance with the inclusion criteria .
METHODS	The 240 patients were divided into control group ( n = 60 , treated with inhalation of oxygen during dressing change ) and treatment group ( n = 180 , treated with inhalation of a mixture of 65 % nitrous oxide and oxygen during dressing change ) according to the computer-generated list of random number .
METHODS	The other treatments in control group and treatment group were the same .
METHODS	Before , during , and after dressing change , heart rate ( HR ) , systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , oxygen saturation ( SO2 ) , and adverse effects were observed .
METHODS	The degree of pain and anxiety felt by the patients were respectively evaluated with the visual analogue scale ( VAS ) and Chinese version of the burn specific pain anxiety scale ( C-BSPAS ) at the same time points as above .
METHODS	Data were processed with analysis of covariance , chi-square test , analysis of variance , and rank sum test .
RESULTS	There were no significant differences between control group and treatment group in the levels of HR , SBP , DBP , and SO2 before dressing change ( with F values respectively 0.76 , 0.06 , 1.11 , 0.70 , P values all above 0.05 ) .
RESULTS	Compared with those of control group , the levels of HR , SBP , DBP , and SO2 in treatment group were significantly ameliorated during dressing change ( with F values respectively 81.78 , 146.36 , 226.44 , 205.62 , P values all below 0.01 ) .
RESULTS	After dressing change , the levels of DBP in the two groups were close ( F = 0.31 , P > 0.05 ) , but the levels of HR , SBP , and SO2 showed statistical differences ( with F values respectively 7.02 , 8.69 , 12.23 , P < 0.05 or P < 0.01 ) .
RESULTS	Before dressing change , the VAS scores were approximate between control group and treatment group ( Z = 0.21 , P > 0.05 ) .
RESULTS	Compared with those in control group ( 9.4 0.7 , 1.7 2.5 ) , the VAS scores were significantly lowered in treatment group during and after dressing change ( 1.6 1.3 , 0.7 1.1 , with Z values respectively 11.84 , 3.35 , P values all below 0.01 ) .
RESULTS	There was no significant difference in C-BSPAS score between control group and treatment group before dressing change ( Z = 0.62 , P > 0.05 ) .
RESULTS	Compared with those in control group ( 75 13 , 73 12 ) , the C-BSPAS scores in treatment group were decreased during and after dressing change ( 9 15 , 9 14 , with Z values respectively 11.91 , 12.28 , P values all below 0.01 ) .
RESULTS	There were no obvious adverse effects in two groups before , during , and after dressing change .
CONCLUSIONS	A mixture of nitrous oxide and oxygen seems to have obvious analgesic and sedative effects on burn patients during dressing change , and it can be widely used .

###25369831
BACKGROUND	Although postmenopausal combined hormone replacement therapy reduces the risk of hip fracture , long-term use may be associated with an increased risk of breast cancer , and in women more than 10 years after menopause it is associated with an increased risk of cardiovascular disease .
BACKGROUND	Isoflavones , because of preferential binding to estrogen receptor beta , may retain the beneficial effects on bone but lessen the adverse effects on the breast .
OBJECTIVE	The objective of this study was to study the effects of an isoflavone obtained from red clover ( Rimostil ) on bone mineral density , and on low-density lipoprotein ( LDL ) cholesterol .
METHODS	In a double-blind , randomized , placebo-controlled trial , 50 mg of Rimostil was given to women who were menopausal for at least 1 year .
METHODS	Bone mineral density of the spine , femoral neck and forearm and serum LDL cholesterol were measured at baseline and at 6-month intervals .
METHODS	The duration of follow-up was 2 years .
RESULTS	There was no beneficial effect of Rimostil on bone density at any site .
RESULTS	There was a 12 % fall in serum LDL cholesterol in the Rimostil-treated arm , which was significantly greater than the 2 % drop seen in the control arm ( P = 0.005 ) .

###24917049
BACKGROUND	Patellofemoral pain syndrome ( PFPS ) is a frequent cause of anterior knee pain predominantly affecting young female patients who do not have significant chondral damage .
BACKGROUND	Development of PFPS is probably multifactorial , involving various knee , hip , and foot kinematic factors .
BACKGROUND	Biomechanical studies have described patellar maltracking and dynamic valgus ( functional malalignment ) in patients with patellofemoral pain syndrome .
BACKGROUND	The literature provides evidence for short-term use of nonsteroidal anti-inflammatory drugs ; short-term medially directed taping ; and exercise programs focusing on the lower extremity , hip , and trunk muscles .
BACKGROUND	Evidence supporting the use of patellar braces is limited because previous studies have been low quality .
BACKGROUND	The aim of this article is to publish the design of a prospective randomized trial that examines the outcomes of patients with PFPS after treatment with a new patellar brace ( Patella Pro ) that applies medially directed force on the patella .
METHODS	For this multicenter trial , 156 patients ( adolescents and young adults ) with PFPS were recruited from orthopedic practices and orthopedic hospitals and randomly allocated to 3 months of supervised physiotherapy in combination with the Patella Pro brace or supervised physiotherapy alone .
METHODS	The primary outcome measures are pain ( numerical analog scale ) ; knee function ( Kujala score and Knee Injury and Osteoarthritis Outcome Score ) ; and self-reported perception of recovery at baseline , 6 weeks , 3 months , and 1 year .
CONCLUSIONS	Only limited evidence for the use of a patellar brace for the treatment of PFPS exists in the literature .
CONCLUSIONS	Disputable evidence for the use of orthoses for PFPS patients has been presented in one meta-analysis , in which only one of three studies found the effect of a medially directed patellar brace to be significant .
CONCLUSIONS	Because of these low-quality studies , the authors concluded that this evidence should be regarded as limited , and we feel there is a need for further well-designed studies to evaluate the effect of patellar bracing on PFPS-related pain .
CONCLUSIONS	The Patella Pro study is a prospective randomized trial in which supervised physiotherapy in combination with a patellar brace is compared with supervised physiotherapy alone .
CONCLUSIONS	This trial started in April 2012 and finished in October 2013 .
BACKGROUND	DRKS-ID : DRKS00003291 , January 3rd , 2012 .

###24708193
OBJECTIVE	To compare the use of fluorine 18 fluorodeoxyglucose ( FDG ) positron emission tomography ( PET ) / computed tomography ( CT ) with the use of a combination of ultrasonography ( US ) and chest radiography for systematic follow-up of patients with high-risk Hodgkin lymphoma .
METHODS	Institutional review board approval and informed consent were obtained .
METHODS	In a single center between January 2001 and December 2009 , patients with advanced-stage Hodgkin lymphoma who had responded completely to first-line treatment were randomly assigned ( 1:1 ) to follow-up with either PET/CT or US/chest radiography .
METHODS	Follow-up included clinical and imaging procedures at 4 , 8 , 12 , 16 , 20 , 24 , 30 , 36 , 48 , 60 , 84 , and 108 months after treatment discontinuation .
METHODS	When clinical and/or imaging results were positive , recurrence was confirmed histologically .
METHODS	The primary endpoint was to compare the sensitivity of the two follow-up imaging approaches .
METHODS	Secondary endpoints were their specificity , positive and negative predictive values , time to recurrence detection , radiation risks , and costs .
RESULTS	A total of 300 patients were randomized into the two arms .
RESULTS	The study was closed after a median follow-up time of 60 months , with a relapse rate of 27 % .
RESULTS	Sensitivity for detection of Hodgkin lymphoma was similar for the two follow-up approaches .
RESULTS	All of the relapses ( 40 of 40 ) were identified with FDG PET/CT ( 100 % ) and 39 of 40 relapses were identified with US/chest radiography ( 97.5 % ; P = .0001 for the equivalence test ) .
RESULTS	US/chest radiography showed significantly higher specificity and positive predictive value than did PET/CT ( 96 % [ 106 of 110 ] vs 86 % [ 95 of 110 ] , respectively ; P = .02 ; and 91 % [ 39 of 43 ] vs 73 % [ 40 of 55 ] , respectively ; P = .01 ) .
RESULTS	Exposure to ionizing radiation was estimated to be 14.5 mSv for one PET/CT examination versus 0.1 mSv for one chest radiographic examination .
RESULTS	Estimated cost per relapse diagnosed with routine PET/CT was 10-fold higher compared with that diagnosed with routine US/chest radiography .
CONCLUSIONS	US and chest radiography are diagnostic tools that enable effective , safe , and low-cost routine surveillance imaging for patients at high risk of Hodgkin lymphoma relapse .

###24321569
BACKGROUND	Laparoscopic gastric plication ( LGP ) is emerging as a safe and effective bariatric procedure .
BACKGROUND	However , there are no reports on the comparison between the efficacy and complications of LGP and laparoscopic mini-gastric bypass ( LMGB ) , which is still an investigational bariatric procedure .
BACKGROUND	The objective of this study was to compare safety and efficacy of LGP and LMGB in the treatment of morbid obesity in a one-year follow-up study .
METHODS	Forty patients met the National Institutes of Health criteria and were randomly assigned to receive either LGP ( n = 20 ) or LMGB ( n = 20 ) by a block randomization method .
METHODS	Early and late complications , body mass index ( BMI ) , excess weight loss , and obesity-related co-morbidities were determined at the 1-year follow-up .
RESULTS	Operative time and mean length of hospitalization were shorter in the LGP group ( 71.0 minutes versus 125.0 minutes , P < .001 , and 1.6 days versus 5.2 days ; P < .001 , respectively ) .
RESULTS	The mean percentage of excess weight loss ( % EWL ) at 12 months follow-up was 66.9 % in the LMGB group and 60.8 % in the LGP group ( P = .34 ) .
RESULTS	Improvement was observed in all co-morbidities in both groups , with the exception of hyperlipidemia , which remained unresolved in 4 patients .
RESULTS	Lower incidence of iron deficiency occurred in the LGP group ( P = .035 ) .
RESULTS	Rehospitalization and reoperation were not required in any cases .
RESULTS	Considering the cost of instruments used in the LMGB procedure and operative time , LGP saved approximately $ 2,500 per case compared with LMGB .
CONCLUSIONS	Both LGP and LMGB are effective weight loss procedures .
CONCLUSIONS	LGP proved to be a simpler and less costly procedure compared with LMGB with a lower risk of iron deficiency during a 1-year follow-up study .

###24716721
OBJECTIVE	Individuals involved in the early stages of a passionate romantic relationship can be consumed by the experience and report emotional dependence and constant focus on their romantic partner .
OBJECTIVE	A few studies have shown that viewing pictures of a romantic partner can significantly reduce experimental pain .
OBJECTIVE	The strength of the effect , however , varies substantially between individuals .
OBJECTIVE	To study why some individuals experience significant pain reduction when looking at a picture of their partner , we examined partner preoccupation .
OBJECTIVE	We hypothesized that a greater degree of preoccupation in the early stages of a romantic relationship would be associated with greater analgesia during a pain induction task .
METHODS	Participants were shown pictures of their romantic partner or an equally attractive and familiar acquaintance while exposed to low , moderate , or high levels of thermal pain .
METHODS	Participants were also asked to rate how much time they spent thinking about their romantic partner during an average day .
METHODS	Degree of preoccupation was defined as the percentage of time participants spent thinking about their partner on an average day .
RESULTS	In two separate experiments , viewing pictures of a romantic partner produced an analgesic effect .
RESULTS	The degree of pain relief was positively correlated with partner preoccupation .
RESULTS	The results suggest that preoccupation with a romantic partner during early stage romantic love is a predictor of pain relief when viewing pictures of the beloved .

###24240641
OBJECTIVE	To compare the relative gentleness of a silicone tape to a paper tape in healthy infants and children .
METHODS	A randomized , grader-blinded , comparative study .
METHODS	The sample group comprised 24 healthy infants and children 9.1 to 46.7 months of age ( mean SEM , 34.0 2.21 ) .
METHODS	The study was conducted at a dermatological research facility ( cyberDERM , Inc ) located in Broomall , Pennsylvania .
METHODS	All volunteers were recruited from the surrounding community .
METHODS	Tapes measuring 1 1.5 inches were randomly applied to the left and right intrascapular regions of the upper back .
METHODS	Tapes were removed in a standardized fashion after 24 hours .
METHODS	The primary study outcome , gentleness , was based on visual assessments of skin damage , discomfort , and quantification of keratin removal .
METHODS	Four-point scales were used to assess skin damage , and a 10-point Faces , Legs , Activity , Cry , and Consolability instrument was used to assess discomfort .
METHODS	Secondary assessments included hair removal , tape edge-lift assessments , and parent preference for either tape .
RESULTS	There was a significantly lower mean SEM erythema response for the silicone tape ( 0.93 0.14 vs 1.35 0.11 , P = .0129 ) than for the paper tape .
RESULTS	No measurable epidermal stripping occurred with the silicone tape compared to a mean SEM response of 0.29 0.11 for the paper tape ( P = .0039 ) .
RESULTS	Discomfort was significantly lower ( P = .0002 ) for the silicone tape as compared to the paper tape ( Faces , Legs , Activity , Cry , and Consolability score mean difference from baseline 0.5 vs 3.3 , P = .0002 ) .
RESULTS	Keratin removal was significantly less with the silicone as compared to paper tape ( 8.7 0.5 g/mL vs 15.2 1.3 g/mL , P < .0001 ) .
RESULTS	Few hairs were removed with either tape .
RESULTS	There was significantly less ( P < .0001 ) edge-lift with the paper tape than the silicone tape ; no statistically significant differences in parent preferences for silicone versus paper tapes were measured ( P = .3359 ) .
CONCLUSIONS	Gentleness assessments favored the silicone tape compared to a paper tape and warrant further clinical investigation in the neonatal intensive care unit .

###26263802
BACKGROUND	The surgical management of symptomatic giant hiatus hernia ( GHH ) aims to improve quality of life ( QoL ) and reduce the risk of life threatening complications .
BACKGROUND	Previous reports are predominantly those with small sample sizes and short follow-up periods .
BACKGROUND	The present study sought to assess a large cohort of patients for recurrence and QoL over a longer time period .
METHODS	This was a follow-up study of a prospectively collected database of 455 consecutive patients .
METHODS	Primary repair of GHH was evaluated by endoscopy/barium meal for recurrence and a standardised symptom questionnaire for QoL .
METHODS	Recurrence was assessed for size , elapsed time , oesophagitis and symptoms .
RESULTS	Objective and subjective review was achieved in 91.9 % and 68.6 % of patients .
RESULTS	The median age was 69 years ( range : 15-93 years ) and 64 % were female .
RESULTS	Laparoscopic repair was completed in 95 % ( mesh in 6 % and Collis gastroplasty in 7 % ) .
RESULTS	The 30-day mortality rate was 0.9 % .
RESULTS	The proportion of patients alive at five and ten years were 90 % and 75 % respectively .
RESULTS	Postoperative QoL scores improved from a mean of 95 to 111 ( p < 0.01 ) and were stable over time ( 112 at 10 years ) .
RESULTS	The overall recurrence rate was 35.6 % ( 149/418 ) at 42 months ; this was 11.5 % ( 48/418 ) for hernias > 2cm and 24.2 % ( 101/418 ) for < 2cm .
RESULTS	The rate of new recurrence at 0-1 years was 13.7 % ( > 2cm = 3.4 % , < 2cm = 10.3 % ) , at 1-5 years it was 30.8 % ( > 2cm = 9.5 % , < 2cm = 21.3 % ) , at 5-10 years it was 40.1 % ( > 2cm = 13.8 % , < 2cm = 26.3 % ) and at over 10 years it was 50.0 % ( > 2cm = 25.0 % , < 2cm = 25.0 % ) .
RESULTS	Recurrence was associated with oesophagitis but not decreased QoL .
RESULTS	Revision surgery was required in 4.8 % of cases ( 14.8 % with recurrence ) .
RESULTS	There were no interval major GHH complications .
CONCLUSIONS	Surgery has provided sustained QoL improvements irrespective of recurrence .
CONCLUSIONS	Recurrence occurred progressively over ten years and may predispose to oesophagitis .

###24765680
OBJECTIVE	To assess the clinical effect of the ` prostatic urethral lift ' ( PUL ) on lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) through a crossover design study .
METHODS	Men aged 50 years with an International Prostate Symptom Score of 13 , a maximum urinary flow rate ( Qmax ) of 12 mL/s , and a prostate of 30-80 mL were enrolled into a crossover study after completing a prospective , randomised , controlled , ` blinded ' pivotal study in which they were control subjects receiving a sham procedure .
METHODS	Patients were followed for 1 year after crossover PUL at 19 centres in the USA , Canada and Australia .
METHODS	The sham procedure involved rigid cystoscopy with simulated active treatment sounds .
METHODS	PUL involved placing permanent UroLift ( NeoTract , Inc. , Pleasanton , CA , USA ) implants into the lateral lobes of the prostate to enlarge the urethral lumen .
METHODS	Urinary symptom relief , health-related quality of life ( HRQL ) impact , urinary flow parameters , sexual function , and adverse events were assessed and compared between the sham and PUL using paired statistical analysis .
RESULTS	Symptom , flow , HRQL and sexual function assessments showed response improvements from baseline results , similar to results from other published studies , and most parameters were markedly improved after PUL vs the sham procedure in the same patients .
RESULTS	Symptom , flow , and HRQL improvements were durable over the 12 months of the study .
RESULTS	Adverse events associated with the procedure were typically transient and mild to moderate ; one patient ( 2 % ) required re-intervention with transurethral resection of the prostate in the first year .
RESULTS	There were no occurrences of de novo , sustained ejaculatory or erectile dysfunction .
CONCLUSIONS	The PUL can be performed under local anaesthesia , causes minimal associated perioperative complications , allows patients to quickly return to normal activity , provides rapid and durable improvement in symptoms , and preserves sexual function .

###24903387
OBJECTIVE	People with atherosclerotic renal artery stenosis may benefit from renin-angiotensin inhibitors , angiotensin-converting enzyme inhibitors , and angiotensin-receptor blockers , but little is known about the factors associated with their use .
METHODS	The Cardiovascular Outcomes in Renal Atherosclerotic Lesions study ( ClinicalTrials.gov identified : NCT00081731 ) is a prospective , international , multicenter clinical trial that randomly assigned participants with atherosclerotic renal artery stenosis who received optimal medical therapy to stenting versus no stenting from May 2005 through January 2010 .
METHODS	At baseline , medication information was available from 853 of 931 randomly assigned participants .
METHODS	Kidney function was measured by serum creatinine-based eGFR at a core laboratory .
RESULTS	Before randomization , renin-angiotensin inhibitors were used in 419 ( 49 % ) of the 853 participants .
RESULTS	Renin-angiotensin inhibitor use was lower in those with CKD ( eGFR < 60 ml/min per 1.73 m ( 2 ) ) ( 58 % versus 68 % ; P = 0.004 ) and higher in individuals with diabetes ( 41 % versus 27 % ; P < 0.001 ) .
RESULTS	Presence of bilateral renal artery stenosis or congestive heart failure was not associated with renin-angiotensin inhibitor use .
RESULTS	Although therapy with renin-angiotensin inhibitors varied by study site , differences in rates of use were not related to the characteristics of the site participants .
RESULTS	Participants receiving a renin-angiotensin inhibitor had lower systolic BP ( mean SD , 148 23 versus 152 23 mmHg ; P = 0.003 ) and more often had BP at goal ( 30 % versus 22 % ; P = 0.01 ) .
CONCLUSIONS	Kidney function and diabetes were associated with renin-angiotensin inhibitor use .
CONCLUSIONS	However , these or other clinical characteristics did not explain variability among study sites .
CONCLUSIONS	Patients with renal artery stenosis who received renin-angiotensin inhibitor treatment had lower BP and were more likely to be at treatment goal .

###24903511
OBJECTIVE	This study was designed to investigate whether patients with stable coronary artery disease ( CAD ) receiving chronic statin treatment who are undergoing noncardiac emergency surgery benefit from acute atorvastatin reload .
METHODS	A total of 500 patients with stable CAD and regular administration of statin before noncardiac emergency surgery were randomized to atorvastatin reload ( n = 250 ) or placebo ( n = 250 ) .
METHODS	All patients received atorvastatin treatment thereafter .
METHODS	The primary end point was a 30-day incidence of major adverse cardiac events ( MACE ) .
METHODS	Secondary end points were the incidence of atrial fibrillation ( AF ) during hospitalization and length of hospital stay .
RESULTS	The primary end point occurred in 2.4 % of patients treated with atorvastatin reload and in 8 % in the placebo arm ( p = 0.0088 ) .
RESULTS	The incidence of AF during hospitalization was 6.8 % in patients treated with atorvastatin reload and 17 % in the placebo arm ( p = 0.0003 ) .
RESULTS	Compared with the placebo arm , the atorvastatin reload arm shortened the length of stay ( 9.8 3.3 vs. 10.6 3.5 days , p = 0.009 ) .
RESULTS	Multivariable analysis suggested that atorvastatin reload conferred a 65 % risk reduction of 30-day MACE ( odds ratio 0.35 , 95 % confidence interval 0.18-0 .86 ; p = 0.005 ) .
CONCLUSIONS	The trial suggests that atorvastatin reload may improve the clinical outcome of patients with stable CAD receiving chronic statin treatment who are undergoing noncardiac emergency surgery .

###25274230
OBJECTIVE	It is commonly known that ultrasonography ( US ) transducers function as both a reservoir and means of transfer for hospital infections .
OBJECTIVE	The current study aimed to compare the antimicrobial effectiveness of using > 80 C water versus antiseptic wipes to disinfect US transducers .
METHODS	Subsequent to abdominal inspections in three groups of 20 patients , a swab culture was taken from the transducer in each case .
METHODS	Neither a mechanical nor chemical disinfection was applied to the transducer in the first group .
METHODS	As for the second group , the transducer was placed in > 80 C hot water for five minutes .
METHODS	In the third group , the transducer was wiped clean using antiseptic wipes .
RESULTS	Of the 60 swab samples collected , 40 did not produce any growth .
RESULTS	The number of samples exhibiting growth in the first group involved 18 cases of coagulase-negative staphylococcus ( CNS ) , as well as 15 cases of Listeria spp. , one case of Corynebacterium spp .
RESULTS	and one case of Bacillus spp. , while only one case of CNS was observed in the second and third groups , respectively .
RESULTS	The culture growth and colony forming units rate were significantly higher in the samples obtained from the first group than in those obtained from the other groups ( p < 0.01 ) .
RESULTS	As for the second and third groups , no significant differences were found in terms of the amount of colonization and growth ( p = 1.00 ) .
CONCLUSIONS	Being a practical and a simple method for particular use in developing and underdeveloped countries , where it is hard to access relatively costly transducer disinfection materials , such as antiseptic wipes , hot water disinfection may play an active role in fighting hospital infections .

###25362008
OBJECTIVE	To study the effect of 2 weeks of prophylactic zinc supplementation on incidence and duration of acute respiratory infections .
METHODS	Randomized double blind controlled trial .
METHODS	Community based ; urban resettlement area in North-East Delhi , India .
METHODS	272 children aged 6-11 months with acute respiratory infections .
METHODS	Children receiving zinc supplement within the past 3 months , severely malnourished , immuno-deficient , on steroid therapy , with severe illness requiring hospitalization , or children of families likely to migrate from the study area were excluded .
METHODS	Placebo ( syrup base ) or zinc ( 20 mg/5 mL elemental zinc as zinc sulfate ) orally given for a period of 2 weeks .
METHODS	Incidence , type and duration of acute respiratory infections , and adverse effects .
RESULTS	No effect on incidence of acute respiratory infections was noted .
RESULTS	A decrease of 15 % ( 0.78-0 .94 ) in days and 12 % ( 0.78-0 .94 ) in duration of episode in acute respiratory infections was observed .
RESULTS	Incidence of acute lower respiratory infections decreased by 62 % ( 0.26-0 .36 ) and the effect remained for full five months of follow up .
RESULTS	There were no drop outs due to side effects .
CONCLUSIONS	Prophylactic zinc supplementation for two weeks may reduce the morbidity due to acute lower respiratory infections but not overall rate of acute respiratory infections in infants aged 6-11 months in similar populations .

###24351693
OBJECTIVE	The purpose of this study was to compare the outcome of primary tooth pulpotomies using two different white mineral trioxide aggregate ( MTA ) cements and calcium hydroxide ( CH ) .
METHODS	Primary molars ( N = 139 ) from three - to nine-year-old children were randomly assigned to be treated using either ProRoot MTA ( N = 46 ) , MTA Angelus ( N = 45 ) , or CH paste ( N = 48 ) as pulpotomy medicaments .
METHODS	All pulpotomized teeth received a Class I amalgam as a final restoration .
METHODS	Recall examinations were carried out at one , three , six , 12 , 18 , and 24 months .
RESULTS	The 24-month cumulative clinical success rates for ProRoot MTA , MTA Angelus , and CH were approximately 98 percent , 96 percent , and 77 percent , respectively .
RESULTS	The cumulative radiographic success rates for ProRoot MTA , MTA Angelus , and CH were approximately 98 percent , 91 percent , and 45 percent , respectively .
RESULTS	For all parameters evaluated , the MTA cements showed similar clinical and radiographic outcomes ( P > .05 ) , which were significantly better than those of CH ( P < .05 ) .
RESULTS	The two-year clinical and radiographic survival probabilities for ProRoot MTA and MTA Angelus were comparable ( P = .62 and P = .20 , respectively ) and superior to calcium hydroxide ( all P > .05 ) .
CONCLUSIONS	ProRoot MTA and MTA Angelus showed similar and favorable success rates as pulpotomy materials in primary molars .

###25543420
OBJECTIVE	To compare the difference in clinical efficacy on chronic obstructive pulmonary disease ( COPD ) at stable stage in the patients among the combined therapy of cutting method and western medication ( combined therapy ) , simple cutting method and simple western medication .
METHODS	One hundred and twenty cases of COPD were randomized into three groups , 40 cases in each one .
METHODS	In the cutting method group , for excessive phlegm pattern/syndrome , Feishu ( BL 13 ) , Danzhong ( CV 17 ) , Dingchuan ( EX-B 1 ) and Yuji ( LU 10 ) were selected as the main acupoints , and Lieque ( LU 7 ) and Pianli ( LI 6 ) were as the supplementary acupoints .
METHODS	For the pattern/syndrome of failure to consolidate kidney primary , Shenshu ( BL 23 ) , Pishu ( BL 20 ) , Guanyuan ( CV 4 ) and Yuji ( LU 10 ) were selected as main acupoints , and Jueyinshu ( BL 14 ) and Zusanli ( ST 36 ) were as the supplementary acupoint .
METHODS	Three acupoints were selected alternatively in each treatment and the cutting method was applied once every 10 days .
METHODS	Three treatments made one session .
METHODS	Two sessions of treatment were required .
METHODS	In the western medication group , salbutamol sulfate aerosol , one press ( 200 g/press ) was used each night , as well as salmeterol xinafoate and fluticasone propionate powder for inhalation , one inhalation each night .
METHODS	The treatment of 1 month made one session .
METHODS	Two sessions were required .
METHODS	In the combined therapy group , the cutting method and western medication were applied in combination .
METHODS	The results of clinical symptom score , lung function test , arterial blood gas analysis , degree of inflation as well as clinical efficacy were observed before and after treatment in each group .
RESULTS	Except the degree of lung inflation , the clinical symptom score , indices of lung function test , partial pressure of arterial blood gas ( PaO2 ) and partial pressure of carbon dioxide ( PaCO2 ) were all obviously improved after treatment as compared with those before treatment in each group ( all P < 0.05 ) .
RESULTS	They were apparently improved after treatment in the combined therapy group and the cutting method group as compared with those in the western medication group ( all P < 0.05 ) .
RESULTS	The total effective rate was 77.5 % ( 31/40 ) in the combined therapy group and was 75.0 % ( 30/40 ) in the cutting method group , both better than 60.0 % ( 24/40 ) in the western medication group ( both P < 0.05 ) .
CONCLUSIONS	The simple cutting method based on syndrome differentiation and the combined therapy with western medication achieve the superior efficacy on COPD at stable stage as compared with the simple western medication .
CONCLUSIONS	The effect mechanism is possibly related to the improvement of bronchial airway function through constant acupoint stimulation .

###24886238
BACKGROUND	All mothers in South Australia are offered a clinic or home-visit by a Child and Family Health community nurse in the initial postnatal weeks .
BACKGROUND	Subsequent support is available on request from staff in community clinics and from a telephone helpline .
BACKGROUND	The aim of the present study is to compare equivalence of a single clinic-based appointment plus a nurse-moderated group-based internet intervention when infants were aged 0-6 months versus a single home-visit together with subsequent standard services ( the latter support was available to mothers in both study groups ) .
METHODS	The evaluation utilised a pragmatic preference randomised trial comparing the equivalence of outcomes for mothers and infants across the two study groups .
METHODS	Eligible mothers were those whose services were provided by nurses working in one of six community clinics in the metropolitan region of Adelaide .
METHODS	Mothers were excluded if they did not have internet access , required an interpreter , or their nurse clinician recommended that they not participate due to issues such as domestic violence or substance abuse .
METHODS	Randomisation was based on the service identification number sequentially assigned to infants when referred to the Child and Family Health Services from birthing units ( this was done by administrative staff who had no involvement in recruiting mothers , delivering the intervention , or analyzing results for the study ) .
METHODS	Consistent with design and power calculations , 819 mothers were recruited to the trial .
METHODS	The primary outcomes for the trial are parents ' sense of competence and self-efficacy measured using standard self-report questionnaires .
METHODS	Secondary outcomes include the quality of mother-infant relationships , maternal social support , role satisfaction and maternal mental health , infant social-emotional and language development , and patterns of service utilisation .
METHODS	Maternal and infant outcomes will be evaluated using age-appropriate questionnaires when infants are aged < 2 months ( pre-intervention ) , 9 , 15 , and 21 months .
CONCLUSIONS	We know of no previous study that has evaluated an intervention that combines the capacity of nurse and internet-based services to improve outcomes for mothers and infants .
CONCLUSIONS	The knowledge gained from this study will inform the design and conduct of community-based postnatal mother and child support programs .
BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12613000204741 .

###25381858
BACKGROUND	House dust contains mite allergens as well as bacterial products such as lipopolysaccharide ( LPS ) .
BACKGROUND	Asthma exacerbations are associated with the level of exposure to allergens and LPS .
BACKGROUND	LPS can potentiate allergen effects in steroid-nave patients .
BACKGROUND	Long-acting 2-agonists ( LABA ) were shown to inhibit LPS-induced bronchial inflammation in healthy volunteers .
BACKGROUND	The aim of this study was to assess the effect of LPS on the allergen-induced eosinophilic inflammation [ primary endpoints : eosinophil counts and eosinophil cationic protein ( ECP ) ] induced by bronchial instillation of house dust mite ( HDM ) in patients with asthma on maintenance treatment with inhaled corticosteroids ( ICS ) .
METHODS	Thirty-two nonsmoking asthmatics with HDM allergy were treated with run-in medication ( fluticasone propionate 100 g bid ) during 2 weeks before the study day .
METHODS	All patients underwent bronchial challenge with HDM , and half of them were randomized to receive additional LPS .
METHODS	Both groups were randomized to receive pretreatment with a single inhalation of 100 g salmeterol 30 min before bronchial segmental challenge .
METHODS	Six hours later , bronchoalveolar lavage ( BAL ) was collected for leukocyte cell count , differentials , and cellular activation markers .
RESULTS	Challenge with HDM/LPS induced a significant increase in eosinophil cationic protein ( P = 0.036 ) and a trend toward an increase in BALF eosinophils as compared to HDM challenge .
CONCLUSIONS	Lipopolysaccharide promotes eosinophilic airway inflammation in patients with asthma despite being on maintenance treatment with ICS .

###24712501
OBJECTIVE	Various positive psychology interventions have been experimentally tested , but only few studies addressed the effects of such activities in participants aged 50 and above .
METHODS	We tested the impact of four self-administered positive psychology interventions in an online setting ( i.e. , gratitude visit , three good things , three funny things , and using signature strengths in a new way ) on happiness and depressive symptoms in comparison with a placebo control exercise ( i.e. , early memories ) .
METHODS	A total of 163 females aged 50-79 tried the assigned interventions or the placebo control exercise for one week and completed measures on happiness and depressive symptoms at five times ( pre - and post-test , 1 , 3 , and 6 months ) .
RESULTS	Three out of the four interventions ( i.e. , gratitude visit , three good things , and using signature strengths in a new way ) increased happiness , whereas two interventions ( three funny things and using signature strengths in a new way ) led to a reduction of depressive symptoms on at one post-measure .
CONCLUSIONS	Positive psychology interventions yield similar results for people aged 50 and above as for younger people .
CONCLUSIONS	The dissemination of such interventions via the Internet offers a valuable opportunity for older age groups as well .

###25552396
BACKGROUND	This prospective randomized pilot study sought to determine whether fixation with Sonoma CRx intramedullary pin is a comparable alternative to minimally invasive plating fixation in patients with displaced clavicle fractures .
METHODS	A total of 45 consecutive patients ( Robinson class B1 or B2 ) were randomly allocated into two groups ; intramedullary pin ( IMP ) group ( n = 24 , mean age ; 33.178.60 years , 14 males 58.3 % ) received Sonoma CRx Collarbone pin ( Sonoma , USA ) whereas locking midshaft superior plating ( MIPPO ) group ( n = 21 , 32.388.41 years , 12 males ) patients received minimally invasive locking midshaft superior plating ( Acumed , USA ) .
METHODS	Patients were followed up with a mean time of 11.824.22 and 14.456.43 months , respectively .
METHODS	Functional status , as the primary outcome measure , was assessed using quick disability of the arm , shoulder and hand ( DASH ) scores .
RESULTS	Mean time of operation and mean time of fluoroscopy were significantly shorter in the IMP group than those in MIPPO group ( p < 0.001 and p = 0.03 , respectively ) .
RESULTS	Time of hospital stay was significantly shorter in IMP group ( p < 0.001 ) .
RESULTS	Complications were rare in the early postoperative period .
RESULTS	Time until bony union was significantly shorter in IMP group .
RESULTS	Mean quick DASH scores were not significantly different between two groups .
RESULTS	Implant failure occurred in one patient from each group .
RESULTS	Cosmetic dissatisfaction was more common in MIPPO group .
CONCLUSIONS	Given the shorter operative times and better cosmetic appearance , Sonoma CRx intramedullary pin may be an alternative to minimally invasive plating .
CONCLUSIONS	Further safety studies are warranted .

###25213806
BACKGROUND	A randomized intervention study , `` Preventive consultations for 20 - to 40-year-old young adults '' , investigated whether preventive consultations with a general practitioner could help young adults with multiple psychosocial and lifestyle problems to change health behavior .
BACKGROUND	To optimize the response rate of questionnaires at 1year post-intervention , the non-responders were reminded by telephone .
BACKGROUND	The aim of this study was to examine potential selection bias induced by non-response by comparing responder and non-responder populations at baseline , and to examine the impact on outcomes by comparing initial respondents to respondents after telephone reminding .
METHODS	Non-responders were compared with primary responders using logistic regression models that included socio-demographic factors , health-related factors , and variables related to the intervention study .
METHODS	In order to describe the impact of including responders after telephone reminding on the intervention 's effect on different health , resource , and lifestyle outcomes , we compared results in models including and excluding responders after telephone reminding .
RESULTS	Telephone contact raised the response by 10 % from 316 ( 64 % ) to 364 ( 74 % ) among young adults with multiple problems .
RESULTS	Being male was the only factor that significantly predicted non-response in the model after adjustment for other variables .
RESULTS	The responders after telephone reminding tended to improve health and lifestyle more than the primary responders , but not significantly so .
RESULTS	Although the additional responses did not change the estimates of the 1-year effect on health and lifestyle changes , it contributed to increased precision of the results .
CONCLUSIONS	Even though the population of primary non-responders had to some degree a different composition than the primary responders , inclusion of responders after telephone reminding did not significantly change the estimates for effect at the 1-year follow-up ; however , the additional responses increased the precision of the estimates .
BACKGROUND	ClinicalTrials.gov : NCT01231256 .

###25307622
BACKGROUND	Echocardiogram reports , but not images , are usually available for the evaluation of potential donor hearts .
BACKGROUND	To assess the reliability of local reports of potential pediatric heart donors , we compared echocardiographic measurements of left ventricular ( LV ) systolic function between local hospitals and a central echocardiography laboratory .
METHODS	We identified all potential donors aged < 18 years managed by the California Transplant Donor Network from 2009 to 2013 .
METHODS	Echocardiograms and reports were obtained from local hospitals .
METHODS	All studies were reviewed in a central laboratory by an experienced pediatric cardiologist blinded to local reports .
METHODS	Local and central measurements of fractional shortening ( FS ) were compared using the Bland-Altman method ( mean difference 2 standard deviations ) .
METHODS	LV function was categorized based on FS as normal or mild , moderately , or severely depressed .
RESULTS	There were 70 studies from 59 donors with local and central measurements of FS .
RESULTS	The mean difference between local and central FS was 3.9 9.0 .
RESULTS	The limits of agreement ranged from -14.2 to 22 .
RESULTS	Twenty-five studies had discordant measurements of LV function , with 17 discordant by 1 category and 8 by 2 or more categories .
RESULTS	Of 55 studies categorized as normal by local measurement , 6 were moderately to severely depressed by central review .
RESULTS	Of 15 studies categorized as depressed by local measurement , 3 were normal by central review .
CONCLUSIONS	Local and central measurements of LV systolic function were discordant in 36 % of studies .
CONCLUSIONS	Given such discordance , efforts to obtain and view actual echocardiographic images should be part of the standard evaluation of potential pediatric heart donors .

###24598154
BACKGROUND	We have shown that a low glutathione concentration and synthesis rate in erythrocytes are associated with a shortage of protein-derived cysteine in children with edematous severe acute malnutrition ( SAM ) .
OBJECTIVE	We tested the hypothesis that methionine supplementation may increase protein-derived cysteine and upregulate cysteine synthesis , thereby improving glutathione synthesis during the early treatment of edematous SAM .
METHODS	The cysteine flux , its de novo synthesis and release from protein breakdown , and erythrocyte glutathione synthesis rate were measured in 12 children with edematous SAM in the fed state by using stable isotope tracers at 3 clinical phases as follows : 3 1 d ( SE ) [ clinical phase 1 ( CP1 ) ] , 8 1 d [ clinical phase 2 ( CP2 ) ] , and 14 2 d ( clinical phase 3 ) after admission .
METHODS	Subjects were randomly assigned to receive equimolar supplements ( 0.5 mmol kg ( -1 ) d ( -1 ) ) of methionine or alanine ( control ) immediately after CP1 .
RESULTS	In the methionine compared with the alanine group , cysteine flux derived from protein breakdown was faster at CP2 than CP1 ( P < 0.05 ) , and the change in plasma cysteine concentration from CP1 to CP2 was greater ( P < 0.05 ) .
RESULTS	However , there was no evidence of a difference in cysteine de novo synthesis and its total flux or erythrocyte glutathione synthesis rate and concentration between groups .
CONCLUSIONS	Methionine supplementation increased cysteine flux from body protein but had no significant effect on glutathione synthesis rates .
CONCLUSIONS	Although cysteine is made from methionine , increased dietary cysteine may be necessary to partially fulfill its demand in edematous SAM because glutathione synthesis rates and concentrations were less than previous values shown at full recovery .
CONCLUSIONS	This study was registered at clinicaltrials.gov as NCT00473031 .

###24509399
BACKGROUND	Trauma stress and neuro-inflammation caused by surgery/anaesthesia releases cytokines .
BACKGROUND	This study analysed impact of Auditory Evoked Potential Index ( AAI ) depth-of-anaesthesia titration on the early plasma IL-6 release after eye surgery under general anaesthesia .
METHODS	This is a subgroup analysis of a prospective randomized study on the effect of auditory evoked potential guided anaesthesia for eye surgery .
METHODS	Plasma IL-6 levels taken before , 5 and 24 h after end of surgery from 450 patients undergoing elective ophthalmic surgery under desflurane anaesthesia were analysed .
METHODS	Minimal mental state examination ( MMSE ) was also tested at 24-h .
RESULTS	IL - 6 increased significantly at both 5 and further at 24 h after surgery ( 3.2 , 4.5 and 5.1 base-line , 5 and 24-h respectively ) , the IL-6 increase showed different patterns between the 2 groups ; IL-6 was significantly increased in the control group of patients between preoperative baseline and 24 h after surgery ( p = 0.008 ) also between 5 h and 24 h , ( p = 0.006 ) after surgery while the AAI-group had only minor non-significant changes .
RESULTS	The 18 patients that showed a 24-h MMSE score less than 25 had a significant higher 24-h IL-6 compared to the 390 patients with a MMSE score > 24 ( p = 0.002 ) .
CONCLUSIONS	The IL-6 increase after surgery was less pronounced in patients where anaesthesia was titrated by AAI compared to anaesthesia adjusted on clinical signs only .
CONCLUSIONS	IL-6 were also found to be higher in patients with a MMSE < 25 at 24-h .
CONCLUSIONS	Further studies are warranted evaluating the role of depth of anaesthesia monitoring on the risk for early cognitive impairment and neuro-inflammation .
BACKGROUND	Clinicaltrials.gov identifier : NA/study were conducted between January 2005-April 2008 .

###25275560
OBJECTIVE	To detect early changes in the metabolic profile of pregnant ewes subject to acute feed restriction at 130 days of gestation , and to establish indicators of risk for ovine pregnancy toxaemia ( OPT ) for diagnostic purposes .
METHODS	Twenty Corriedale ewes with known mating dates , carrying a single fetus , were used .
METHODS	Ewes were maintained on meadow grasslands and at 130 days of gestation were randomly divided in two groups of 10 ewes .
METHODS	The control group had ad libitum access to pasture .
METHODS	Ewes in the restricted group were subjected to an acute feed restriction for a maximum of 144 hours ( 6 days ) , with free access to water .
METHODS	From the start ( 0 hours ) until the end of feed restriction , blood samples were collected from all ewes to monitor concentrations of cortisol , non-esterified fatty acids ( NEFA ) , - hydroxybutyrate ( BOHB ) daily , and glucose in plasma every 6 hours ; urinary pH was also measured .
METHODS	Every 6 hours the food restricted ewes were observed to detect clinical signs of OPT e.g. apathy , grinding teeth , empty chewing movements , head leaning against the wall , tachypnea and not drinking water .
RESULTS	In food-restricted ewes , concentrations of glucose decreased and differed from control ewes from 54 to 90 hours ( p < 0.001 ) , and 96 to 102 hours ( p < 0.05 ) .
RESULTS	Concentrations of BOHB , cortisol and NEFA increased following feed restriction and differed from control ewes after 48 to 144 hours ( p < 0.01 ) .
RESULTS	Eight of the 10 restricted ewes showed clinical signs of OPT after 102-132 hours .
RESULTS	Mean concentrations of glucose , BOHB and cortisol differed between control and restricted ewes prior to the onset of clinical signs of OPT , after 48-96 hours of feed restriction ( p < 0.01 ) .
RESULTS	Mean gestational length , and time from birth to placental expulsion was not affected by the feed restriction .
CONCLUSIONS	Our results suggest that concentrations of glucose , BOHB and cortisol in plasma may provide a precocious diagnosis of subclinical OPT , using values of 1.59 ( SD 0.24 ) mmol/L , 2.26 ( SD 1.03 ) mmol/L and 15.09 ( SD 7.75 ) nmol/L , respectively .
CONCLUSIONS	The identification of a potentially harmful metabolic imbalance could lead to the improvement of treatment success .

###24461758
BACKGROUND	Recurrence of tuberculosis after treatment makes management difficult and is a key factor for determining treatment efficacy .
BACKGROUND	Two processes can cause recurrence : relapse of the primary infection or re-infection with an exogenous strain .
BACKGROUND	Although re-infection can and does occur , its importance to tuberculosis epidemiology and its biological basis is still debated .
BACKGROUND	We used whole-genome sequencing-which is more accurate than conventional typing used to date-to assess the frequency of recurrence and to gain insight into the biological basis of re-infection .
METHODS	We assessed patients from the REMoxTB trial-a randomised controlled trial of tuberculosis treatment that enrolled previously untreated participants with Mycobacterium tuberculosis infection from Malaysia , South Africa , and Thailand .
METHODS	We did whole-genome sequencing and mycobacterial interspersed repetitive unit-variable number of tandem repeat ( MIRU-VNTR ) typing of pairs of isolates taken by sputum sampling : one from before treatment and another from either the end of failed treatment at 17 weeks or later or from a recurrent infection .
METHODS	We compared the number and location of SNPs between isolates collected at baseline and recurrence .
RESULTS	We assessed 47 pairs of isolates .
RESULTS	Whole-genome sequencing identified 33 cases with little genetic distance ( 0-6 SNPs ) between strains , deemed relapses , and three cases for which the genetic distance ranged from 1306 to 1419 SNPs , deemed re-infections .
RESULTS	Six cases of relapse and six cases of mixed infection were classified differently by whole-genome sequencing and MIRU-VNTR .
RESULTS	We detected five single positive isolates ( positive culture followed by at least two negative cultures ) without clinical evidence of disease .
CONCLUSIONS	Whole-genome sequencing enables the differentiation of relapse and re-infection cases with greater resolution than do genotyping methods used at present , such as MIRU-VNTR , and provides insights into the biology of recurrence .
CONCLUSIONS	The additional clarity provided by whole-genome sequencing might have a role in defining endpoints for clinical trials .
BACKGROUND	Wellcome Trust , European Union , Medical Research Council , Global Alliance for TB Drug Development , European and Developing Country Clinical Trials Partnership .

###24245493
BACKGROUND	Cardiac rehabilitation programs aim to improve health status and to decrease the risk of further cardiac events .
BACKGROUND	Persons undergoing rehabilitation often have difficulties transferring the learned health behaviors into their daily routine after returning home and maybe to work .
BACKGROUND	This includes physical activity as well as fruit and vegetable consumption .
BACKGROUND	Computer-based tailored interventions have been shown to be effective in increasing physical activity as well as fruit and vegetable consumption .
BACKGROUND	The aim of this study is , to support people in transferring these two learned behavior changes and their antecedents into their daily life after cardiac rehabilitation .
METHODS	The study will have a randomized controlled design and will be conducted among German and Dutch people who participated in cardiac rehabilitation .
METHODS	The study will consist of one intervention group which will be compared to a waiting list control group .
METHODS	During the eight week duration of the intervention , participants will be invited to participate in the online after-care program once per week .
METHODS	The intervention encourages participants to define individual health behavior goals as well as action , and coping plans to reach these self-determined goals .
METHODS	The effectiveness of the program will be compared between the intervention condition and the control group in terms of behavior change , antecedents of behavior change ( e.g. , self-efficacy ) , ability to return to work and increased well-being .
METHODS	Further , subgroup-differences will be assessed including differences between the two countries , socioeconomic inequalities and across age groups .
CONCLUSIONS	The present study will make a contribution to understanding how such an online-based tailored interventions enables study participants to adopt and maintain a healthy lifestyle .
CONCLUSIONS	Implications can include how such an online program could enrich cardiac rehabilitation aftercare further .
BACKGROUND	NTR 3706 , NCT01909349 .

###25652873
BACKGROUND	An AS03-adjuvanted H5N1 influenza vaccine elicited broad and persistent immune responses with an acceptable safety profile up to 6 months following the first vaccination in children aged 3-9 years .
METHODS	In this follow-up of the Phase II study , we report immunogenicity persistence and safety at 24 months post-vaccination in children aged 3-9 years .
METHODS	The randomized , open-label study assessed two doses of H5N1 A/Vietnam/1194 / 2004 influenza vaccine ( 19 g or 375 g hemagglutinin antigen ) formulated with AS03A or AS03B ( 1189 mg or 593 mg tocopherol , respectively ) .
METHODS	Control groups received seasonal trivalent influenza vaccine .
METHODS	Safety was assessed prospectively and included potential immune-mediated diseases ( pIMDs ) .
METHODS	Immunogenicity was assessed by hemagglutination-inhibition assay 12 and 24 months after vaccination ; cross-reactivity and cell-mediated responses were also assessed .
METHODS	( NCT00502593 ) .
RESULTS	The safety population included 405 children .
RESULTS	Over 24 months , five events fulfilled the criteria for pIMDs , of which four occurred in H5N1 vaccine recipients , including uveitis ( n = 1 ) and autoimmune hepatitis ( n = 1 ) , which were considered to be vaccine-related .
RESULTS	Overall , safety profiles of the vaccines were clinically acceptable .
RESULTS	Humoral immune responses at 12 and 24 months were reduced versus those observed after the second dose of vaccine , although still within the range of those observed after the first dose .
RESULTS	Persistence of cell-mediated immunity was strong , and CD4 ( + ) T cells with a TH 1 profile were observed .
CONCLUSIONS	Two doses of an AS03-adjuvanted H5N1 influenza vaccine in children showed low but persistent humoral immune responses and a strong persistence of cell-mediated immunity , with clinically acceptable safety profiles up to 24 months following first vaccination .

###24369254
OBJECTIVE	To compare the efficacy and safety of recombinant human interferon -2 b ( INF-2b ) monotherapy and combined therapy with entecavir ( ETV ) plus adefovir dipivoxil ( ADV ) in chronic hepatitis B patients with poor response to combined therapy with lamivudine and ADV.
METHODS	A total of 161 patients with chronic hepatitis B refractory to to combined therapy with lamivudine ( LAM ) and ADV were randomized to receive INF-2b monotherapy ( 510 ( 6 ) , three times a week ) ( group A ) or combined therapy with entecavir ( 0.5 mg/day ) plus adefovir ( 10 mg/day ) ( group B ) .
METHODS	Serum levels of HBsAg , HBeAg and HBV viral load were analyzed at 48 weeks using chemiluminescence assay and by real-time PCR as appropriate .
METHODS	The drug resistance genes in HBV was tested by direct DNA sequencing .
RESULTS	At 48 weeks of treatment , HBV DNA decreased significantly in groups A and B to 2.061.15 log10 copies/ml and 1.771.28 log10 copies/ml , respectively .
RESULTS	The rates of viral response , serological response , and biochemical response in groups A and B were 48.15 % ( 39/81 ) vs 53.75 % ( 43/80 ) , 61.70 % ( 50/81 ) vs 53.75 % ( 43/80 ) , and 49.38 % ( 40/81 ) vs 60.00 % ( 48/80 ) , showing no significant differences between the two groups ( P > 0.05 ) .
RESULTS	The drug resistance gene mutation rate was significanty higher in group B ( 64.86 % , 24/37 ) than in group A ( 30.95 % , 13/42 , P < 0.05 ) .
CONCLUSIONS	Chronic hepatitis B patients refractory to lamivudine combined with ADV have a good response to INF-2b monotherapy and combined therapy with entecavir and ADV , and interferon treatment is preferred to reduce potential drug resistance gene mutations .

###24963568
BACKGROUND	Cryptococcal meningitis accounts for 20 to 25 % of acquired immunodeficiency syndrome-related deaths in Africa .
BACKGROUND	Antiretroviral therapy ( ART ) is essential for survival ; however , the question of when ART should be initiated after diagnosis of cryptococcal meningitis remains unanswered .
METHODS	We assessed survival at 26 weeks among 177 human immunodeficiency virus-infected adults in Uganda and South Africa who had cryptococcal meningitis and had not previously received ART .
METHODS	We randomly assigned study participants to undergo either earlier ART initiation ( 1 to 2 weeks after diagnosis ) or deferred ART initiation ( 5 weeks after diagnosis ) .
METHODS	Participants received amphotericin B ( 0.7 to 1.0 mg per kilogram of body weight per day ) and fluconazole ( 800 mg per day ) for 14 days , followed by consolidation therapy with fluconazole .
RESULTS	The 26-week mortality with earlier ART initiation was significantly higher than with deferred ART initiation ( 45 % [ 40 of 88 patients ] vs. 30 % [ 27 of 89 patients ] ; hazard ratio for death , 1.73 ; 95 % confidence interval [ CI ] , 1.06 to 2.82 ; P = 0.03 ) .
RESULTS	The excess deaths associated with earlier ART initiation occurred 2 to 5 weeks after diagnosis ( P = 0.007 for the comparison between groups ) ; mortality was similar in the two groups thereafter .
RESULTS	Among patients with few white cells in their cerebrospinal fluid ( < 5 per cubic millimeter ) at randomization , mortality was particularly elevated with earlier ART as compared with deferred ART ( hazard ratio , 3.87 ; 95 % CI , 1.41 to 10.58 ; P = 0.008 ) .
RESULTS	The incidence of recognized cryptococcal immune reconstitution inflammatory syndrome did not differ significantly between the earlier-ART group and the deferred-ART group ( 20 % and 13 % , respectively ; P = 0.32 ) .
RESULTS	All other clinical , immunologic , virologic , and microbiologic outcomes , as well as adverse events , were similar between the groups .
CONCLUSIONS	Deferring ART for 5 weeks after the diagnosis of cryptococcal meningitis was associated with significantly improved survival , as compared with initiating ART at 1 to 2 weeks , especially among patients with a paucity of white cells in cerebrospinal fluid .
CONCLUSIONS	( Funded by the National Institute of Allergy and Infectious Diseases and others ; COAT ClinicalTrials.gov number , NCT01075152 . )

###25139882
OBJECTIVE	Glucagon delivery in closed-loop control of type 1 diabetes is effective in minimizing hypoglycemia .
OBJECTIVE	However , high insulin concentration lowers the hyperglycemic effect of glucagon , and small doses of glucagon in this setting are ineffective .
OBJECTIVE	There are no studies clearly defining the relationship between insulin levels , subcutaneous glucagon , and blood glucose .
METHODS	Using a euglycemic clamp technique in 11 subjects with type 1 diabetes , we examined endogenous glucose production ( EGP ) of glucagon ( 25 , 75 , 125 , and 175 g ) at three insulin infusion rates ( 0.016 , 0.032 , and 0.05 units/kg/h ) in a randomized , crossover study .
METHODS	Infused 6,6-dideuterated glucose was measured every 10 min , and EGP was determined using a validated glucoregulatory model .
METHODS	Area under the curve ( AUC ) for glucose production was the primary outcome , estimated over 60 min .
RESULTS	At low insulin levels , EGP rose proportionately with glucagon dose , from 5 68 to 112 152 mg/kg ( P = 0.038 linear trend ) , whereas at high levels , there was no increase in glucose output ( 19 53 to 26 38 mg/kg , P = NS ) .
RESULTS	Peak glucagon serum levels and AUC correlated well with dose ( r2 = 0.63 , P < 0.001 ) , as did insulin levels with insulin infusion rates ( r2 = 0.59 , P < 0.001 ) .
CONCLUSIONS	EGP increases steeply with glucagon doses between 25 and 175 g at lower insulin infusion rates .
CONCLUSIONS	However , high insulin infusion rates prevent these doses of glucagon from significantly increasing glucose output and may reduce glucagon effectiveness in preventing hypoglycemia when used in the artificial pancreas .

###24285128
OBJECTIVE	The aim of our study was to evaluate renal function assessed by serum creatinine as well as novel biomarkers in 142 patients with stable coronary heart disease and normal serum creatinine undergoing percutaneous coronary interventions ( PCI ) depending on the type of hydration : physiological saline vs. sodium bicarbonate ( 1:1 randomization ) .
METHODS	Serum and urinary NGAL were evaluated before and after 8-12 , and 24 hours after PCI .
METHODS	Serum cystatin C , serum creatinine , estimated glomerular filtration rate using different formulae were assessed before PCI , and 24 hours after the procedure .
RESULTS	Only 2 patients ( 2.8 % ) from the saline-hydrated group fulfilled the criteria for CI-AKI .
RESULTS	In patients hydrated with sodium bicarbonate serum creatinine declined significantly ( p < 0.01 ) .
RESULTS	In patients hydrated with sodium bicarbonate a significant fall in serum NGAL after 8-12 hours was found .
RESULTS	In sodium bicarbonate group cystatin C decreased non significantly after 8-12 hours , then returned to the baseline values .
RESULTS	In patients hydrated with physiological saline serum NGAL before PCI and after 24 hours correlated positively with cystatin C and eGFR by CKD-EPI .
RESULTS	In patients hydrated with sodium bicarbonate baseline serum NGAL correlated with NGAL baseline cystatin C and eGFR by CKD-EPI , similarly serum NGAL after 24 hours correlated with cystatin C.
CONCLUSIONS	We suggest to rather use sodium bicarbonate in a hydration protocol in patients undergoing PCI .
CONCLUSIONS	However , the value of NGAL in this setting remains to be elucidated and volume expansion remain the unquestionable prevention methods of CI-AKI .

###25291923
OBJECTIVE	To evaluate the sustainability of dedicated education units ( DEUs ) within an academic-service partnership .
BACKGROUND	A two-year , multisite , mixed-methods study with a randomized control trial was designed to isolate the effects of the DEU innovation on clinical education quality , teaching capacity , work life , and productivity .
METHODS	Interview data from 34 participants were analyzed for interactions and behaviors that indicated sustainability .
RESULTS	Seven themes portrayed successful participant interactions , revealing shifting roles based on mutual respect and collaboration among engaged partners working within complex adaptive systems .
RESULTS	Relationship building and partnership achievements were confirmed as key components in DEU sustainability .
CONCLUSIONS	Sustainable , mature clinical education partnerships depend on implementing routinizing , reinforcing , recognizing , and rewarding activities .
CONCLUSIONS	Unit level success relies on foundational structures that support the ongoing development of DEU clinical instructors .
CONCLUSIONS	DEU sustainability will depend on the continual creation of new meaning for participants and the generation of new resources and results .

###24975432
BACKGROUND	There is wide interindividual variation in response to morphine for cancer-related pain ; 30 % of patients do not have a good therapeutic outcome .
BACKGROUND	Alternative opioids such as oxycodone are increasingly being used , and opioid switching has become common clinical practice .
OBJECTIVE	To compare clinical response to oral morphine vs. oral oxycodone when used as first-line or second-line ( after switching ) treatment in patients with cancer-related pain .
METHODS	In this prospective , open-label , randomized , controlled trial ( ISRCTN65155201 ) with a selected crossover phase , patients with cancer-related pain were randomized to receive either oral morphine or oxycodone as first-line treatment .
METHODS	Dose was individually titrated until the patient reported adequate pain control .
METHODS	Patients who did not respond to the first-line opioid ( either because of inadequate analgesia or unacceptable adverse effects ) were switched to the alternative opioid .
RESULTS	Two hundred patients were recruited .
RESULTS	On intention-to-treat analysis ( n = 198 , morphine 98 , oxycodone 100 ) , there was no significant difference between the numbers of patients responding to morphine ( 61/98 = 62 % ) or oxycodone ( 67/100 = 67 % ) when used as a first-line opioid .
RESULTS	Similarly , there was no significant difference in subsequent response when patients were switched to either morphine ( 8/12 = 67 % ) or oxycodone ( 11/21 = 52 % ) .
RESULTS	Per-protocol analysis demonstrated a 95 % response rate when both opioids were available .
RESULTS	There was no difference in adverse reaction scores between morphine and oxycodone either in first-line responders or nonresponders .
CONCLUSIONS	In this population , there was no difference between analgesic response or adverse reactions to oral morphine and oxycodone when used as a first - or second-line opioid .
CONCLUSIONS	These data provide evidence to support opioid switching to improve outcomes .

###24548534
BACKGROUND	New York City ( NYC ) is currently home to the largest Bangladeshi population in the United States ( US ) at approximately 62,000 individuals .
BACKGROUND	The high prevalence of Type 2 diabetes mellitus ( T2DM ) among Bangladeshis has been well documented in Bangladesh , as well as in Canada and the United Kingdom ( UK ) .
BACKGROUND	However , little is known about the diabetes prevalence and management practices of US Bangladeshis .
BACKGROUND	This paper describes the protocol for a Community Health Worker ( CHW ) intervention to improve diabetic management and control among Bangladeshis with diabetes in NYC .
METHODS	For a two-arm , randomized controlled trial ( RCT ) , investigators will recruit a sample of 256 participants , all of whom are 1 ) of Bangladeshi descent , 2 ) residing in NYC , 3 ) diagnosed with T2DM and a recent Hemoglobin A1c ( HbA1c ) of6 .5 , and 4 ) between the ages of 21-85 .
METHODS	The treatment group receives a six-month CHW-led intervention consisting of five monthly group educational sessions , two one-on-one visits , and follow-up phone calls as needed from a CHW .
METHODS	The control group receives an introductory educational session only .
METHODS	Primary and secondary outcomes include clinical and behavioral measures , such as HbA1c and weight change , access to and utilization of care ( i.e. appointment keeping and use of specialty care ) , and knowledge and practice of physical activity and healthful eating .
METHODS	Additionally , information regarding CHW characteristics , the processes and mechanisms for influencing healthful behavior change , and fidelity of the intervention are collected .
METHODS	Outcomes are measured at Baseline , 3-Months , 6-Months for both groups , and at 12-Months for the treatment group .
CONCLUSIONS	To our knowledge , this study represents the first attempt to document the efficacy of T2DM management strategies in the NYC Bangladeshi population .
CONCLUSIONS	Thus , future qualitative and quantitative findings of the submitted protocol will fill an important gap in the health disparities literature .
BACKGROUND	NCT02041598 .

###25204437
BACKGROUND	Greater than 70 % of patients with cancer experience chemotherapy-induced nausea and vomiting .
BACKGROUND	In the current study , the authors examined the effects of electrostimulation of the K1 acupoint located on the sole of the foot because it is believed to have the potential to control chemotherapy-induced nausea and vomiting .
METHODS	In this trial , 103 patients diagnosed with primary or metastatic liver cancer were recruited before transcatheter arterial infusion ( TAI ) of cisplatin or oxaliplatin and randomized to either group A ( 51 patients who were treated with the antiemetic tropisetron and acustimulation at the K1 acupoint for 20 minutes approximately 1 to 2 hours before TAI on the first day and then daily for the subsequent 5 days ) or group B ( 52 patients who were treated with tropisetron and electrostimulation at a placebo point on the heel ) .
METHODS	The rate , intensity , and duration of nausea and vomiting were collected at baseline and then daily for 5 days after TAI .
METHODS	Quality of life was assessed daily using the MD Anderson Symptom Inventory and the EuroQoL scale .
RESULTS	No differences were found between groups A and B with regard to the incidence and degree of nausea or vomiting on day 1 or the following 5 days .
RESULTS	Patients in group A had better EuroQoL scores compared with patients in group B ( 72.83 in group A vs 65.94 in group B ; P = .04 ) on day 4 but not on the other days .
RESULTS	No group differences were noted at any time point for MD Anderson Symptom Inventory scores .
CONCLUSIONS	Electrostimulation of K1 combined with antiemetics did not result in initial prevention of cisplatin-induced or oxaliplatin-induced nausea or vomiting .

###25436225
OBJECTIVE	Health-related quality of life in adults , who in adolescence participated in a scoliosis-specific exercise program , was not previously studied .
OBJECTIVE	Design .
OBJECTIVE	Cross-sectional study , with retrospective data collection .
METHODS	Homogenous groups of 68 persons ( 43 women ) aged 30.10 ( 25-39 ) years , with mild or moderate scoliosis , and 76 ( 38 women ) able-bodied persons , aged 30.11 ( 24-38 ) years , who 16.5 ( 12-26 ) years earlier had completed scoliosis-specific exercise or observation regimes , participated .
METHODS	Their respiratory characteristics did not differ from predicted values .
METHODS	The WHOQOL-BREF questionnaire , Oswestry Disability Questionnaire , and pain scale ( VAS ) were applied .
RESULTS	The transformed WHOQOL-BREF scores ranged from 54.6 11.19 in the physical domain in the mild scoliotic subgroup to 77.1 16.05 in the social domain in the able-bodied subgroup .
RESULTS	The ODQ values did not generally exceed 5.3 7.53 .
RESULTS	Inter - and intragroup differences were nonsignificant .
RESULTS	Age , marital status , education , and gender were significantly associated with the ODQ scores .
RESULTS	Significant association between the ODQ and WHOQOL-BREF social relationships domain scores with the participation in exercise treatment was found .
CONCLUSIONS	Participants with the history of exercise treatment generally did not differ significantly from their peers who were only under observation .
CONCLUSIONS	This study can not conclude that scoliosis-specific exercise treatment in adolescence alters quality of life in adulthood .

###24879841
OBJECTIVE	To determine the safety and efficacy of an automated unified safety system ( USS ) in providing overnight closed-loop ( OCL ) control in children and adolescents with type 1 diabetes attending diabetes summer camps .
METHODS	The Diabetes Assistant ( DIAS ) USS used the Dexcom G4 Platinum glucose sensor ( Dexcom ) and t : slim insulin pump ( Tandem Diabetes Care ) .
METHODS	An initial inpatient study was completed for 12 participants to evaluate safety .
METHODS	For the main camp study , 20 participants with type 1 diabetes were randomized to either OCL or sensor-augmented therapy ( control conditions ) per night over the course of a 5 - to 6-day diabetes camp .
RESULTS	Subjects completed 54 OCL nights and 52 control nights .
RESULTS	On an intention-to-treat basis , with glucose data analyzed regardless of system status , the median percent time in range , from 70-150 mg/dL , was 62 % ( 29 , 87 ) for OCL nights versus 55 % ( 25 , 80 ) for sensor-augmented pump therapy ( P = 0.233 ) .
RESULTS	A per-protocol analysis allowed for assessment of algorithm performance .
RESULTS	The median percent time in range , from 70-150 mg/dL , was 73 % ( 50 , 89 ) for OCL nights ( n = 41 ) versus 52 % ( 24 , 83 ) for control conditions ( n = 39 ) ( P = 0.037 ) .
RESULTS	There was less time spent in the hypoglycemic range < 50 , < 60 , and < 70 mg/dL during OCL compared with the control period ( P = 0.019 , P = 0.009 , and P = 0.023 , respectively ) .
CONCLUSIONS	The DIAS USS algorithm is effective in improving time spent in range as well as reducing nocturnal hypoglycemia during the overnight period in children and adolescents with type 1 diabetes in a diabetes camp setting .

###24334868
BACKGROUND	To our knowledge there has been no study investigating the impact of freeze-dried strawberry ( FDS ) supplementation on metabolic biomarkers of atherosclerosis in subjects with type 2 diabetes ( T2D ) .
OBJECTIVE	This study was carried out to determine the effects of FDS supplementation on glycemic control , biomarkers of oxidative stress , inflammation and serum total antioxidant status in subjects with T2D compared to matched control subjects .
METHODS	Thirty-six subjects with T2D ( 23 females ; mean body mass index 27.90 3.7 ; mean age 51.57 10 years ) were randomly divided into two groups .
METHODS	The treatment group consumed 2 cups of FDS beverage ( 50 g of FDS is equivalent to 500 g of fresh strawberries ) or macronutrient matched placebo powder with strawberry flavor daily for 6 weeks in a randomized double-blind controlled trial .
METHODS	Anthropometric measurements , dietary intakes , hemoglobin ( Hb ) A1c , antioxidant status , C-reactive protein and malondialdehyde ( MDA ) levels were assessed at baseline and 6 weeks post-intervention .
RESULTS	FDS supplementation significantly decreased C-reactive protein levels as a biomarker of inflammation ( 2.5 vs. 2.04 mg/l , p < 0.05 ) and lipid peroxidation in the form of MDA ( 3.36 vs. 2.7 nmol/ml , p < 0.05 ) at 6 weeks compared to the baseline .
RESULTS	Moreover , supplementation led to a decreasing trend in HbA1c ( -5.7 % , p < 0.05 ) and significant increase in total antioxidant status in the FDS group ( 1.44 vs. 1.26 mmol/l , p < 0.01 ) compared to the placebo group .
RESULTS	No significant changes were observed in serum glucose concentrations and anthropometric indices .
CONCLUSIONS	FDS improved glycemic control and antioxidant status , and reduced lipid peroxidation and inflammatory response in patients with T2D .
CONCLUSIONS	Supplementation with freeze-dried berry products , as natural sources of antioxidants with low glycemic index , could be considered as an adjunctive therapy in ameliorating metabolic complications of T2D .

###24473673
OBJECTIVE	To assess the 1-year efficacy and safety of a regimen of tocilizumab plus methotrexate or placebo , which was augmented by a treat-to-target strategy from week 24 .
METHODS	ACT-RAY was a double-blind , 3-year trial .
METHODS	Adults with active rheumatoid arthritis despite methotrexate were randomised to add tocilizumab to ongoing methotrexate ( add-on strategy ) or to switch to tocilizumab plus placebo ( switch strategy ) .
METHODS	Tocilizumab 8 mg/kg was administered every 4 weeks .
METHODS	Conventional open-label disease-modifying antirheumatic drugs ( DMARDs ) other than methotrexate were added at week 24 or later in patients with DAS28 > 3.2 .
RESULTS	556 patients were randomised ; 85 % completed 52 weeks .
RESULTS	The proportion of patients receiving open-label DMARDs was comparable in the add-on ( 29 % ) and switch ( 33 % ) arms .
RESULTS	Overall , week 24 results were maintained or further improved at week 52 in both arms .
RESULTS	Some endpoints favoured the add-on strategy .
RESULTS	Mean changes in Genant-modified Sharp scores were small ; more add-on ( 92.8 % ) than switch patients ( 86.1 % ) had no radiographic progression .
RESULTS	At week 52 , comparable numbers of patients had antidrug antibodies ( ADAs ; 1.5 % and 2.2 % of add-on and switch patients , respectively ) and neutralising ADAs ( 0.7 % and 1.8 % ) .
RESULTS	Rates of serious adverse events and serious infections per 100 patient-year ( PY ) were 11.3 and 4.5 in add-on and 16.8 and 5.5 in switch patients .
RESULTS	In patients with normal baseline values , alanine aminotransferase elevations > 3 upper limit of normal were observed in 11 % of add-on and 3 % of switch patients .
CONCLUSIONS	Despite a trend favouring the add-on strategy , these data suggest that both tocilizumab add-on and switch strategies led to meaningful clinical and radiographic responses .

###25410633
OBJECTIVE	Depression is the most prevalent psychiatric disorder in persons with epilepsy ( PWEs ) .
OBJECTIVE	Despite its major impact on quality of life and risk of suicide , most PWEs are not treated for depression .
OBJECTIVE	A current challenge in mental health care is how to close this treatment gap and increase access to psychological services .
OBJECTIVE	Psychological online interventions ( POIs ) have shown efficacy in improving depression among individuals without neurologic disorders .
OBJECTIVE	This pilot study aimed to assess the feasibility and efficacy of a psychological online intervention for depression ( Deprexis ) in PWEs who have symptoms of depression .
METHODS	Participants with self-reported epilepsy and subjective complaints of depressive symptoms were randomized to an intervention condition ( Deprexis ) or to a waiting list control ( WLC ) condition .
METHODS	After 9weeks , participants were invited to complete an online reassessment .
RESULTS	Relative to the waiting list group , program users experienced a significant symptom decline on the Beck Depression Inventory - I ( BDI-I , primary outcome ) with a moderate effect size in the complete observations analysis and a small effect size in the intention-to-treat analysis .
RESULTS	Furthermore , there was a significant improvement with a moderate effect size on the `` energy/fatigue '' subscale of the Quality of Life In Epilepsy Inventory - 31 ( QOLIE-31 ) .
CONCLUSIONS	The results of this trial suggest that POIs may be a feasible and beneficial tool for PWEs who have comorbid depressive symptoms .

###24555751
BACKGROUND	This study investigates the effect of photodynamic therapy ( PDT ) as monotherapy during supportive periodontal therapy .
METHODS	A split-mouth , randomized controlled trial was conducted in patients with chronic periodontitis ( N = 22 ) presenting at least three residual pockets ( probing depth [ PD ] 5 mm with bleeding on probing [ BOP ] ) .
METHODS	The selected sites randomly received the following : 1 ) PDT ; 2 ) photosensitizer ( PS ) ; or 3 ) scaling and root planing ( SRP ) .
METHODS	At baseline and 3 and 6 months , clinical , microbiologic ( real-time polymerase chain reaction analyses ) , cytokine pattern ( multiplexed bead immunoassay ) , and patient-centered ( regarding morbidity ) evaluations were performed .
RESULTS	All therapies promoted similar improvements in clinical parameters throughout the study ( P < 0.05 ) , except that BOP was not reduced in the PS protocol ( P > 0.05 ) .
RESULTS	Lower levels of Aggregatibacter actinomycetemcomitans were observed in the PDT and SRP protocols at 3 months when compared with the PS protocol ( P < 0.05 ) .
RESULTS	An inferior frequency detection of Porphyromonas gingivalis was observed in the PDT protocol at 3 and 6 months and in the SRP protocol at 6 months from baseline ( P < 0.05 ) .
RESULTS	In addition , PDT protocol presented inferior frequency of P. gingivalis at 3 months when compared with the other therapies ( P < 0.05 ) .
RESULTS	Only patients in the PDT protocol exhibited augmented levels of anti-inflammatory interleukin ( IL ) -4 and reduced proinflammatory IL-1 and IL-6 throughout the study ( P < 0.05 ) .
RESULTS	Intergroup analyses showed reduced IL-10 and increased interferon - and IL-1 levels in the PS protocol when compared with the other therapies during follow-ups ( P < 0.05 ) .
RESULTS	No differences in morbidity were observed between the therapies ( P > 0.05 ) , although the need for anesthesia was higher in SRP-treated sites ( P < 0.05 ) .
CONCLUSIONS	PDT as an exclusive therapy may be considered a non-invasive alternative for treating residual pockets , offering advantages in the modulation of cytokines .

###24655542
BACKGROUND	Functional dyspepsia ( FD ) is a common health problem currently without any optimal treatments .
BACKGROUND	Acupuncture has been traditionally sought as a treatment for FD .
BACKGROUND	The aim of this study is to investigate whether acupuncture treatment helps improve symptoms of FD .
METHODS	A two-center , randomized , waitlist-controlled trial will be carried out to evaluate whether acupuncture treatment improves FD symptoms .
METHODS	Seventy six participants aged 18 to 75 years with FD as diagnosed by Rome III criteria will be recruited from August 2013 to January 2014 at two Korean Medicine hospitals .
METHODS	They will be randomly allocated either into eight sessions of partially individualized acupuncture treatment over 4 weeks or a waitlist group .
METHODS	The acupuncture group will then be followed-up for 3 weeks with six telephone visits and a final visit will be paid at 8 weeks .
METHODS	The waitlist group will receive the identical acupuncture treatment after a 4-week waiting period .
METHODS	The primary outcome is the proportion of responders with adequate symptom relief and the secondary outcomes include Nepean dyspepsia index , EQ-5D , FD-related quality of life , Beck 's depression inventory , state-trait anxiety inventory questionnaire , and level of ghrelin hormone .
METHODS	The protocol was approved by the participating centers ' Institutional Review Boards .
CONCLUSIONS	Results of this trial will help clarify not only whether the acupuncture treatment is beneficial for symptom improvement in FD patients but also to elucidate the related mechanisms of how acupuncture might work .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01921504 .

###24526136
OBJECTIVE	An examination of the effects of up to 260 weeks of growth hormone ( GH ) therapy on metabolic parameters in Japanese children born small for gestational age ( SGA ) .
METHODS	Data were analysed from a 156-week extension of a 104-week multicentre , randomised , double-blind , parallel-group trial .
METHODS	Sixty-five children born SGA ( age 3 - < 8 years ) received 33 g/kg/day ( n = 31 , 64.5 % male ) or 67 g/kg/day ( n = 34 , 58.8 % male ) GH for 260 weeks .
METHODS	Changes in metabolic parameters - glucose , insulin , total cholesterol , low-density lipoprotein cholesterol and high-density lipoprotein cholesterol - were recorded .
METHODS	Alterations in weight , body mass index standard deviation score ( BMI SDS ) and vital signs were also evaluated .
RESULTS	Over 260 weeks of GH treatment , a positive correlation between height SDS and insulin-like growth factor-I SDS was observed .
RESULTS	Insulin and glucose levels were generally unaffected .
RESULTS	Favourable changes in lipid profiles were recorded , which were maintained for the study duration .
RESULTS	No adverse alterations in weight , BMI SDS or vital signs were noted .
CONCLUSIONS	Long-term , continuous GH treatment in children born SGA appears to be efficacious , associated with potential benefits for several metabolic parameters and associated with no long-term safety concerns .

###25453520
OBJECTIVE	To investigate whether a footbath inhibits spasticity in the hemiplegic lower limbs of post-stroke patients .
METHODS	Randomized , controlled study .
METHODS	Rehabilitation education and research hospital .
METHODS	Twenty-two post-stroke patients were randomly allocated to control or experimental groups .
METHODS	After relaxing in a supine posture for 30min , the experimental group subject 's legs were immersed in 41C water below the knee joint for 15min , while the control group remained in a resting posture .
METHODS	Modified Ashworth Scale ( MAS ) scores of the affected triceps surae muscle and F-wave parameters ( i.e. , F-wave amplitude , F/M ratio , and F-wave persistence ) were recorded before , immediately after , and 30min after each intervention .
METHODS	Physiological parameters were simultaneously monitored to determine the thermo-therapeutic mechanisms and side effects of footbath usage .
RESULTS	At the time immediately after the intervention , F-wave amplitudes decreased significantly in the experimental group , compared to the control group ( p < 0.01 , difference : -106.8 ; 95 % CI ; -181.58 to -32.09 ) .
RESULTS	F-wave amplitudes decreased significantly after 30-min intervention in the experimental group , with a total reduction of 161.2 V being recorded compared to 8.8 V increase in the control group ( p < 0.01 , difference : -170.0 ; 95 % CI ; -252.73 to -87.33 ) .
RESULTS	There were also significant differences between the experimental and control group for both F/M ratio and F-wave persistence , immediately after and 30min after the intervention .
RESULTS	Further , there were significant differences between the experimental and control group for the MAS scores immediately after the intervention ( p < 0.05 , difference : -0.72 ; 95 % CI ; -1.262 to -0.193 ) , and 30min after the intervention ( p < 0.05 , difference : -0.73 ; 95 % CI ; -1.162 to -0.293 ) .
CONCLUSIONS	These findings demonstrate that the use of footbaths is an effective non-pharmacological anti-spastic treatment for use in stroke rehabilitation .

###25355131
BACKGROUND	Advancements in mobile phone technology offer huge potential for enhancing the timely delivery of health behavior change interventions .
BACKGROUND	The development of smartphone-based health interventions ( apps ) is a rapidly growing field of research , yet there have been few longitudinal examinations of how people experience and use these apps within their day-to-day routines , particularly within the context of a hybrid Web - and app-based intervention .
OBJECTIVE	This study used an in-depth mixed-methods design to examine individual variation in ( 1 ) impact on self-reported goal engagement ( ie , motivation , self-efficacy , awareness , effort , achievement ) of access to a weight management app ( POWeR Tracker ) when provided alongside a Web-based weight management intervention ( POWeR ) and ( 2 ) usage and views of POWeR Tracker .
METHODS	Thirteen adults were provided access to POWeR and were monitored over a 4-week period .
METHODS	Access to POWeR Tracker was provided in 2 alternate weeks ( ie , weeks 1 and 3 or weeks 2 and 4 ) .
METHODS	Participants ' goal engagement was measured daily via self-report .
METHODS	Mixed effects models were used to examine change in goal engagement between the weeks when POWeR Tracker was and was not available and whether the extent of change in goal engagement varied between individual participants .
METHODS	Usage of POWeR and POWeR Tracker was automatically recorded for each participant .
METHODS	Telephone interviews were conducted and analyzed using inductive thematic analysis to further explore participants ' experiences using POWeR and POWeR Tracker .
RESULTS	Access to POWeR Tracker was associated with a significant increase in participants ' awareness of their eating ( 1 = 0.31 , P = .04 ) and physical activity goals ( 1 = 0.28 , P = .03 ) .
RESULTS	The level of increase varied between individual participants .
RESULTS	Usage data showed that participants used the POWeR website for similar amounts of time during the weeks when POWeR Tracker was ( mean 29 minutes , SD 31 minutes ) and was not available ( mean 27 minutes , SD 33 minutes ) .
RESULTS	POWeR Tracker was mostly accessed in short bursts ( mean 3 minutes , SD 2 minutes ) during convenient moments or moments when participants deemed the intervention content most relevant .
RESULTS	The qualitative data indicated that nearly all participants agreed that it was more convenient to access information on-the-go via their mobiles compared to a computer .
RESULTS	However , participants varied in their views and usage of the Web - versus app-based components and the informational versus tracking tools provided by POWeR Tracker .
CONCLUSIONS	This study provides evidence that smartphones have the potential to improve individuals ' engagement with their health-related goals when used as a supplement to an existing online intervention .
CONCLUSIONS	The perceived convenience of mobile access to information does not appear to deter use of Web-based interventions or strengthen the impact of app access on goal engagement .
CONCLUSIONS	A mixed-methods design enabled exploration of individual variation in daily usage of the app-based tools .

###24651895
BACKGROUND	Though theoretically superior to standard 2D visualization , 3D video systems have not yet achieved a breakthrough in laparoscopy .
BACKGROUND	The latest 3D monitors , including autostereoscopic displays and high-definition ( HD ) resolution , are designed to overcome the existing limitations .
METHODS	We performed a randomized study on 48 individuals with different experience levels in laparoscopy .
METHODS	Three different 3D displays ( glasses-based 3D monitor , autostereoscopic display , and a mirror-based theoretically ideal 3D display ) were compared to a 2D HD display by assessing multiple performance and mental workload parameters and rating the subjects during a laparoscopic suturing task .
METHODS	Electromagnetic tracking provided information on the instruments ' pathlength , movement velocity , and economy .
METHODS	The usability , the perception of visual discomfort , and the quality of image transmission of each monitor were subjectively rated .
RESULTS	Almost all performance parameters were superior with the conventional glasses-based 3D display compared to the 2D display and the autostereoscopic display , but were often significantly exceeded by the mirror-based 3D display .
RESULTS	Subjects performed a task faster and with greater precision when visualization was achieved with the 3D and the mirror-based display .
RESULTS	Instrument pathlength was shortened by improved depth perception .
RESULTS	Workload parameters ( NASA TLX ) did not show significant differences .
RESULTS	Test persons complained of impaired vision while using the autostereoscopic monitor .
RESULTS	The 3D and 2D displays were rated user-friendly and applicable in daily work .
RESULTS	Experienced and inexperienced laparoscopists profited equally from using a 3D display , with an improvement in task performance about 20 % .
CONCLUSIONS	Novel 3D displays improve laparoscopic interventions as a result of faster performance and higher precision without causing a higher mental workload .
CONCLUSIONS	Therefore , they have the potential to significantly impact the further development of minimally invasive surgery .
CONCLUSIONS	However , as shown by the custom-built 3D mirror display , this effect can be improved , thus stimulating further research .

###25651247
BACKGROUND	Magnesium sulfate is neuroprotective in preclinical models of stroke and has shown signals of potential efficacy with an acceptable safety profile when delivered early after stroke onset in humans .
BACKGROUND	Delayed initiation of neuroprotective agents has hindered earlier phase 3 trials of neuroprotective agents .
METHODS	We randomly assigned patients with suspected stroke to receive either intravenous magnesium sulfate or placebo , beginning within 2 hours after symptom onset .
METHODS	A loading dose was initiated by paramedics before the patient arrived at the hospital , and a 24-hour maintenance infusion was started on the patient 's arrival at the hospital .
METHODS	The primary outcome was the degree of disability at 90 days , as measured by scores on the modified Rankin scale ( range , 0 to 6 , with higher scores indicating greater disability ) .
RESULTS	Among the 1700 enrolled patients ( 857 in the magnesium group and 843 in the placebo group ) , the mean ( SD ) age was 6913 years , 42.6 % were women , and the mean pretreatment score on the Los Angeles Motor Scale of stroke severity ( range , 0 to 10 , with higher scores indicating greater motor deficits ) was 3.71.3 .
RESULTS	The final diagnosis of the qualifying event was cerebral ischemia in 73.3 % of patients , intracranial hemorrhage in 22.8 % , and a stroke-mimicking condition in 3.9 % .
RESULTS	The median interval between the time the patient was last known to be free of stroke symptoms and the start of the study-drug infusion was 45 minutes ( interquartile range , 35 to 62 ) , and 74.3 % of patients received the study-drug infusion within the first hour after symptom onset .
RESULTS	There was no significant shift in the distribution of 90-day disability outcomes on the global modified Rankin scale between patients in the magnesium group and those in the placebo group ( P = 0.28 by the Cochran-Mantel-Haenszel test ) ; mean scores at 90 days did not differ between the magnesium group and the placebo group ( 2.7 in each group , P = 1.00 ) .
RESULTS	No significant between-group differences were noted with respect to mortality ( 15.4 % in the magnesium group and 15.5 % in the placebo group , P = 0.95 ) or all serious adverse events .
CONCLUSIONS	Prehospital initiation of magnesium sulfate therapy was safe and allowed the start of therapy within 2 hours after the onset of stroke symptoms , but it did not improve disability outcomes at 90 days .
CONCLUSIONS	( Funded by the National Institute of Neurological Disorders and Stroke ; FAST-MAG ClinicalTrials.gov number , NCT00059332 . )

###24509688
OBJECTIVE	To compare left ventricular function after a long-term His or para-His pacing ( HP ) and right ventricular septal pacing ( RVSP ) in patients with atrioventricular block ( AVB ) .
RESULTS	We included consecutive patients with AVB , a narrow QRS < 120 ms , and a preserved left ventricular ejection fraction ( LVEF ) > 0.40 , in a prospective , randomized , double-blinded , crossover design .
RESULTS	All patients were treated with 12 months HP and 12 months RVSP .
RESULTS	A total of 38 patients [ mean age , 67 10 years ; 30 ( 79 % ) men ] were included .
RESULTS	The primary endpoint was LVEF , which was significantly lower after a 12 months RVSP ( 0.50 0.11 ) than after 12 months of HP ( 0.55 0.10 ) , P = 0.005 .
RESULTS	We measured the difference in time-to-peak systolic velocity between opposite basal segments in the apical views by using tissue Doppler imaging .
RESULTS	In the four-chamber view , the difference was 58 ( 7 ) ms after RVSP and 49 ( 7 ) ms after HP , P = 0.27 ; in the two-chamber view , the difference was 45 ( 5 ) ms after RVSP and 31 ( 4 ) ms after HP , P = 0.02 , and in the apical long-axis view , the difference was 63 ( 6 ) after RVSP and 44 ( 7 ) after HP , P = 0.03 .
RESULTS	There was no difference in New York Heart Association class , 6-min hall walk test , quality-of-life assessments , or device-related complications .
RESULTS	The mean threshold was significantly higher in HP leads than in RVSP leads .
CONCLUSIONS	His or para-His pacing preserves LVEF and mechanical synchrony as compared with RVSP after 12 months pacing in patients with AVB , narrow QRS , and LVEF > 0.40 .

###24500028
BACKGROUND	People with psychosis often experience weight gain , which places them at risk of cardiovascular disease , diabetes , and early death .
OBJECTIVE	To determine the uptake , adherence , and clinical effectiveness of a healthy living intervention designed to reduce weight gain .
METHODS	An exploratory randomized controlled trial , comparing the intervention with treatment as usual ( TAU ) in 2 early intervention services for psychosis in England .
METHODS	DSM-IV classification was the diagnostic criteria used to assign the psychiatric diagnoses .
METHODS	The primary outcome was change in body mass index ( BMI ) from baseline to 12-month follow-up .
METHODS	The study was conducted between February 2009 and October 2012 .
RESULTS	105 service users , with a BMI of 25 ( 24 in South Asians ) , were randomized to intervention ( n = 54 ) or TAU ( n = 51 ) after stratification by recent commencement of antipsychotic medication .
RESULTS	Ninety-three service users ( 89 % ) were followed up at 12 months .
RESULTS	Between-group difference in change in BMI was not significant ( effect size = 0.11 ) .
RESULTS	The effect of the intervention was larger ( effect size = 0.54 , not significant ) in 15 intervention ( 28 % ) and 10 TAU ( 20 % ) participants who were taking olanzapine or clozapine at randomization .
CONCLUSIONS	The healthy living intervention did not show a significant difference in BMI reduction compared to the TAU group .
BACKGROUND	www.isrctn.org identifier : ISRCTN22581937 .

###25263744
OBJECTIVE	Prader-Willi syndrome is a neurogenetic disorder , with characteristics such as obesity , short stature , muscular weakness , intellectual deficiencies and deviant social behaviour .
OBJECTIVE	This study evaluated whether growth hormone treatment of children with Prader-Willi syndrome resulted in possible and lasting effects on their cognition and behaviour .
METHODS	We randomised six girls and 13 boys to either a treatment group or a control group .
METHODS	The treatment group received growth hormone ( Genotropin ( ) 0.033 mg/kg/day ) for 2 years , while the control group did not receive treatment in the first year and then received a double dose in the second year .
METHODS	Treatment was then stopped in both groups for 6 months .
RESULTS	Both groups showed the same intellectual disabilities at the start of the study , and no difference was found after the first and second years .
RESULTS	The parents reported that the children showed increased vitality during treatment .
RESULTS	When treatment was stopped , the children showed a marked exacerbation of behavioural problems , a significant increase in body fat and a decrease in insulin-like growth factor 1 levels .
CONCLUSIONS	We believe this is the first study to show that abrupt-ceasing growth hormone treatment led to a successive deterioration in behavioural problems in children with Prader-Willi syndrome .

###25058218
OBJECTIVE	Aside from the multikinase inhibitor sorafenib , there are no effective systemic therapies for the treatment of advanced hepatocellular carcinoma .
OBJECTIVE	To assess the efficacy of everolimus in patients with advanced hepatocellular carcinoma for whom sorafenib treatment failed .
METHODS	EVOLVE-1 was a randomized , double-blind , phase 3 study conducted among 546 adults with Barcelona Clinic Liver Cancer stage B or C hepatocellular carcinoma and Child-Pugh A liver function whose disease progressed during or after sorafenib or who were intolerant of sorafenib .
METHODS	Patients were enrolled from 17 countries between May 2010 and March 2012 .
METHODS	Randomization was stratified by region ( Asia vs rest of world ) and macrovascular invasion ( present vs absent ) .
METHODS	Everolimus , 7.5 mg/d , or matching placebo , both given in combination with best supportive care and continued until disease progression or intolerable toxicity .
METHODS	Per the 2:1 randomization scheme , 362 patients were randomized to the everolimus group and 184 patients to the placebo group .
METHODS	The primary end point was overall survival .
METHODS	Secondary end points included time to progression and the disease control rate ( the percentage of patients with a best overall response of complete or partial response or stable disease ) .
RESULTS	No significant difference in overall survival was seen between treatment groups , with 303 deaths ( 83.7 % ) in the everolimus group and 151 deaths ( 82.1 % ) in the placebo group ( hazard ratio [ HR ] , 1.05 ; 95 % CI , 0.86-1 .27 ; P = .68 ; median overall survival , 7.6 months with everolimus , 7.3 months with placebo ) .
RESULTS	Median time to progression with everolimus and placebo was 3.0 months and 2.6 months , respectively ( HR , 0.93 ; 95 % CI , 0.75-1 .15 ) , and disease control rate was 56.1 % and 45.1 % , respectively ( P = .01 ) .
RESULTS	The most common grade 3/4 adverse events for everolimus vs placebo were anemia ( 7.8 % vs 3.3 % , respectively ) , asthenia ( 7.8 % vs 5.5 % , respectively ) , and decreased appetite ( 6.1 % vs 0.5 % , respectively ) .
RESULTS	No patients experienced hepatitis C viral flare .
RESULTS	Based on central laboratory results , hepatitis B viral reactivation was experienced by 39 patients ( 29 everolimus , 10 placebo ) ; all cases were asymptomatic , but 3 everolimus recipients discontinued therapy .
CONCLUSIONS	Everolimus did not improve overall survival in patients with advanced hepatocellular carcinoma whose disease progressed during or after receiving sorafenib or who were intolerant of sorafenib .
BACKGROUND	clinicaltrials.gov Identifier : NCT01035229 .

###25979833
BACKGROUND	Right - and left-sided colon cancers ( RC , LC ) differ with respect to biology , pathology and epidemiology .
BACKGROUND	Previous data suggest a mortality difference between RC and LC .
BACKGROUND	We examined if primary tumour side also predicts for outcome in chemotherapy refractory , metastatic colon cancer ( MCC ) .
BACKGROUND	We also compared RC versus LC as a predictor of efficacy of epidermal growth factor receptor ( EGFR ) inhibition with cetuximab .
METHODS	Reanalyzing NCIC CO. 17 trial ( cetuximab versus best supportive care [ BSC ] ) , we coded the primary tumour side as RC ( caecum to transverse colon ) or LC ( splenic flexure to rectosigmoid ) .
METHODS	The association between tumour side and baseline characteristics was assessed .
METHODS	Cox regression models determined factors affecting overall survival ( OS ) and progression free survival ( PFS ) .
RESULTS	Patients with RC ( 150/399 ) had more poorly differentiated , mutant KRAS , mutated PIK3CA and wild-type BRAF tumours , fewer liver and lung metastases , and shorter interval between diagnosis and study entry .
RESULTS	Among BSC patients , tumour side was not prognostic for PFS ( hazard ratios ( HR ) 1.07 [ 0.79-1 .44 ] , p = 0.67 ) or OS ( HR 0.96 [ 0.70-1 .31 ] , p = 0.78 ) .
RESULTS	Among wild-type KRAS patients , those with LC had significantly improved PFS when treated with cetuximab compared to BSC ( median 5.4 versus 1.8 months , HR 0.28 [ 0.18-0 .45 ] , p < 0.0001 ) , whereas those with RC did not ( median 1.9 versus 1.9 months , HR 0.73 [ 0.42-1 .27 ] , p = 0.26 ) , [ interaction p = 0.002 ] .
CONCLUSIONS	In refractory MCC , tumour location within the colon is not prognostic , but is strongly predictive of PFS benefit from cetuximab therapy .
CONCLUSIONS	Additional research is needed to understand the molecular differences between RC and LC and their interaction with EGFR inhibition .

###25636808
BACKGROUND	There is evidence of an association between pulmonary function and various nutrients , although no association has been observed in our setting between the Mediterranean Diet ( MD ) eating pattern and improved lung function .
BACKGROUND	The objective of this study is to evaluate the effect of an intervention designed to increase MD adherence on lung function in smokers with no previous respiratory disease .
METHODS	Randomized , controlled , parallel clinical trial .
METHODS	primary health care centers in Catalonia ( Spain ) .
METHODS	Current smokers ( cumulative > 10 pack-years ) aged 35-70 years , with Internet access , who provide signed informed consent to participate .
METHODS	A nutritionist will conduct a 2-year multicomponent intervention to increase MD adherence , based on : 1 ) a personalized dietary-nutritional education intervention , 2 ) a Web 2.0 approach , the DIET Blog of nutritional information , and 3 ) group sessions to increase motivation to increase MD adherence and motivation to make changes in eating habits .
METHODS	Annually , an office visit and one group session will reinforce the nutritional intervention .
METHODS	The control group will follow their usual diet , with general nutritional counselling .
METHODS	In both groups , a 14-item questionnaire will evaluate individual MD dietary patterns and forced spirometry will assess lung function .
METHODS	Intention to treat .
METHODS	The unit of analysis will be the individual smoker .
METHODS	Primary outcome is lung function indicated by spirometry , FVC , FEV1 and FEV1/FVC % .
METHODS	Lung function parameters in both groups will be compared by adherence to the MD pattern .
CONCLUSIONS	The DIET study could contribute data on a protective action of the MD pattern on lung function in smokers .
CONCLUSIONS	If so , this population may benefit from a nutritional intervention , along with the fundamental recommendation to stop smoking .
BACKGROUND	ClinicalTrials.gov : NCT02151669 .
BACKGROUND	Registered 26 May 2014 .

###24700581
BACKGROUND	The effects of opioid medication on cognitive functioning in patients with cancer and non-cancer pain remain unclear .
METHODS	In this mechanistic randomized , double-blind , placebo-controlled , cross-over study of patients ( n = 20 ) receiving sustained-release and immediate-release opioid medication as part of their palliative care , we examine memory effects of an additional dose of participants ' immediate-release medication ( oxycodone or morphine ) or placebo .
METHODS	Immediate prose recall and recall of related and unrelated word pairs was assessed pre-and post-drug ( placebo or immediate-release opioid ) .
METHODS	Memory for these stimuli was also tested after a delay on each testing occasion .
METHODS	Finally , performance on an ` interference ' word pair task was assessed on the two testing occasions since proactive interference has been posited as a mechanism for acute opioid-induced memory impairment .
RESULTS	Unlike previous work , we found no evidence of memory impairment for material presented before or after individually tailored , ` breakthrough ' doses of immediate-release opioid .
RESULTS	Furthermore , immediate-release opioid did not result in increased memory interference .
RESULTS	On the other hand , we found enhanced performance on the interference word pair task after immediate-release opioid , possibly indicating lower levels of interference .
CONCLUSIONS	These results suggest that carefully titrated immediate-release doses of opioid drugs may not cause extensive memory impairment as previously reported , and in fact , may improve memory in certain circumstances .
CONCLUSIONS	Importantly , our findings contrast strikingly with those of a study using the same robust design that showed significant memory impairment .
CONCLUSIONS	We propose that factors , such as depressive symptoms , education level and sustained-release opioid levels may influence whether impairment is observed following immediate-release opioid treatment .

###25789827
BACKGROUND	Emergency abdominal surgery carries a considerable risk of death and postoperative complications .
BACKGROUND	Early detection and timely management of complications may reduce mortality .
BACKGROUND	The aim was to evaluate the effect and feasibility of intermediate care compared with standard ward care in patients who had emergency abdominal surgery .
METHODS	This was a randomized clinical trial carried out in seven Danish hospitals .
METHODS	Eligible for inclusion were patients with an Acute Physiology And Chronic Health Evaluation ( APACHE ) II score of at least 10 who were ready to be transferred to the surgical ward within 24h of emergency abdominal surgery .
METHODS	Participants were randomized to either intermediate care or standard surgical ward care after surgery .
METHODS	The primary outcome was 30-day mortality .
RESULTS	In total , 286 patients were included in the modified intention-to-treat analysis .
RESULTS	The trial was terminated after the interim analysis owing to slow recruitment and a lower than expected mortality rate .
RESULTS	Eleven ( 76 per cent ) of 144 patients assigned to intermediate care and 12 ( 85 per cent ) of 142 patients assigned to ward care died within 30 days of surgery ( odds ratio 091 , 95 per cent c.i. 038 to 216 ; P = 0828 ) .
RESULTS	Thirty ( 208 per cent ) of 144 patients assigned to intermediate care and 37 ( 261 per cent ) of 142 assigned to ward care died within the total observation period ( hazard ratio 078 , 95 per cent c.i. 048 to 126 ; P = 0310 ) .
CONCLUSIONS	Postoperative intermediate care had no statistically significant effect on 30-day mortality after emergency abdominal surgery , nor any effect on secondary outcomes .
CONCLUSIONS	The trial was stopped prematurely owing to slow recruitment and a much lower than expected mortality rate among the enrolled patients .
BACKGROUND	NCT01209663 ( http://www.clinicaltrials.gov ) .

###24280478
OBJECTIVE	To examine the effects of a group music therapy on psychiatric symptoms and depression for patient with schizophrenia in a psychiatric nursing home .
METHODS	Eighty patients with schizophrenia were randomly assigned to a music intervention group ( MIG ) or usual care group ( UCG ) .
METHODS	Both groups received similar medical and routine care .
METHODS	The MIG received a 60-min group music therapy twice a week , a total of ten sessions .
METHODS	The UAG only received the usual care with no music therapy .
METHODS	Psychiatric symptoms and depression assessments were conducted using the positive and negative syndrome scale and the depression scale for schizophrenia at baseline , the posttest , and at a 3-month follow-up .
RESULTS	Thirty-eight patients in the MIG and 42 in the UCG completed the study .
RESULTS	After 10 sessions of group music therapy , the groups showed statistically significant differences in psychiatric symptoms ( p < .05 ) and depression status ( p < .05 ) .
CONCLUSIONS	Group music therapy is an economical and easily implemented method of improving depression and psychiatric symptoms in patients with schizophrenia .

###24939648
BACKGROUND	The Stroke Oxygen Study ( SOS ) is a multi-center randomized controlled trial of oxygen supplementation in patients with acute stroke .
BACKGROUND	The main hypothesis for the trial is that fixed-dose oxygen treatment during the first 3 days after an acute stroke improves outcome .
BACKGROUND	The secondary hypothesis is that restricting oxygen supplementation to night time only is more effective than continuous supplementation .
BACKGROUND	This paper describes the statistical analysis plan for the study .
METHODS	Patients ( n = 8000 ) are randomized to three groups : ( 1 ) continuous oxygen supplementation for 72 hours ; ( 2 ) nocturnal oxygen supplementation for three nights ; and ( 3 ) no routine oxygen supplementation .
METHODS	Outcomes are recorded at 7 days , 90 days , 6 months , and 12 months .
METHODS	The primary outcome measure is the modified Rankin scale at 90 days .
METHODS	Data will be analyzed according to the intention-to-treat principle .
METHODS	Methods of statistical analysis are described , including the handling of missing data , the covariates used in adjusted analyses , planned subgroups analyses , and planned sensitivity analyses .
BACKGROUND	This trial is registered with the ISRCTN register , number ISRCTN52416964 ( 30 September 2005 ) .

###24717946
BACKGROUND	There has been no nationwide epidemiological investigation of allergic rhinitis ( AR ) that was diagnosed by both questionnaires and laboratory tests in Korea .
BACKGROUND	This study investigated the prevalence , risk factors , and comorbidities of AR in South Korea .
METHODS	The Korean National Health and Nutritional Examination Survey examined a representative sample of the Korean population .
METHODS	A total of 2305 participants underwent immunoradiometric assay for specific IgE antibodies against common indoor allergens .
METHODS	Healthy , atopy only , and AR groups were defined according to the results of allergen test .
METHODS	The weighted prevalence for each group was calculated .
METHODS	Risk factors including food and comorbidities were identified using univariate or multivariate analyses .
METHODS	The patients were also categorized into four subgroups according to the Allergic Rhinitis and Its Impact on Asthma ( ARIA ) classification and associated comorbidities were analyzed .
RESULTS	The prevalence of atopy only and AR was 30.0 1.2 % and 16.2 1.0 % , respectively .
RESULTS	The multivariate analysis showed that the prevalence was influenced by sex ( p < 0.01 ) for atopy only and sex ( p = 0.09 ) , age ( p = 0.02 ) , marital status ( p = 0.24 ) , and stress level ( p = 0.30 ) for AR .
RESULTS	Compared with the healthy group , asthma ( odds ratio [ OR ] = 4.77 ) , nasal polyp ( NP ; OR = 3.44 ) , chronic rhinosinusitis ( OR = 13.93 ) , and olfactory dysfunction ( OR = 4.88 ) were more prevalent in the AR group .
RESULTS	Based on the ARIA guideline , intermittent mild rhinitis was most common ( 58.1 % ) .
RESULTS	Asthma was correlated to severity and atopic dermatitis and NPs was associated with persistency .
RESULTS	Daily intake of less mackerel and more carrots , bread , and bean curd were associated with the increased risk of AR .
CONCLUSIONS	Prevalence , risk factors , and comorbidities of AR were evaluated in the general Korean population , which will contribute to prevention and treatment of AR and its comorbidities in Koreans .

###24731015
BACKGROUND	Exercise training is recommended for non-cystic fibrosis ( CF ) bronchiectasis , but the long-term effects are unclear .
BACKGROUND	This randomised controlled trial aimed to determine the effects of exercise training and review of airway clearance therapy ( ACT ) on exercise capacity , health related quality of life ( HRQOL ) and the incidence of acute exacerbations in people with non-CF bronchiectasis .
METHODS	Participants were randomly allocated to 8weeks of supervised exercise training and review of ACT , or control .
METHODS	Primary outcomes of exercise capacity and HRQOL ( Chronic respiratory disease questionnaire ) and secondary outcomes of cough-related QOL ( Leicester cough questionnaire ) and psychological symptoms ( Hospital anxiety and depression scale ) were measured at baseline , following completion of the intervention period and at 6 and 12months follow up .
METHODS	Secondary outcomes of the exacerbation rate and time to first exacerbation were analysed over 12months .
RESULTS	Eighty-five participants ( mean FEV1 74 % predicted ; median Modified Medical Research Council Dyspnoea grade of 1 ( IQR [ 1-3 ] ) were included .
RESULTS	Exercise training increased the incremental shuttle walk distance ( mean difference to control 62m , 95 % CI 24 to 101m ) and the 6-minute walking distance ( mean difference to control 41m , 95 % CI 19 to 63m ) , but these improvements were not sustained at 6 or 12months .
RESULTS	Exercise training reduced dyspnoea ( p = 0.009 ) and fatigue ( p = 0.01 ) but did not impact on cough-related QOL or mood .
RESULTS	Exercise training reduced the frequency of acute exacerbations ( median 1 [ IQR 1-3 ] ) compared to the control group ( 2 [ 1-3 ] ) over 12months follow up ( p = 0.012 ) , with a longer time to first exacerbation with exercise training of 8months ( 95 % CI 7 to 9months ) compared to the control group ( 6months [ 95 % CI 5 to 7months ] , p = 0.047 ) .
CONCLUSIONS	Exercise training in bronchiectasis is associated with short term improvement in exercise capacity , dyspnoea and fatigue and fewer exacerbations over 12months .
BACKGROUND	ClinicalTrials.gov ( NCT00885521 ) .

###24267102
BACKGROUND	Failure to return to pregnancy weight by 6 months postpartum is associated with long-term obesity , as well as adverse health outcomes .
BACKGROUND	This research evaluated a postpartum weight management programme for women with a body mass index ( BMI ) > 25 kg m ( -2 ) that combined behaviour change principles and a low-intensity delivery format with postpartum nutrition information .
METHODS	Women were randomised at 24-28 weeks to control ( supported care ; SC ) or intervention ( enhanced care ; EC ) groups , stratified by BMI cohort .
METHODS	At 36 weeks of gestation , SC women received a ` nutrition for breastfeeding ' resource and EC women received a nutrition assessment and goal-setting session about post-natal nutrition , plus a 6-month correspondence intervention requiring return of self-monitoring sheets .
METHODS	Weight change , anthropometry , diet , physical activity , breastfeeding , fasting glucose and insulin measures were assessed at 6 weeks and 6 months postpartum .
RESULTS	Seventy-seven percent ( 40 EC and 41 SC ) of the 105 women approached were recruited ; 36 EC and 35 SC women received a programme and 66.7 % and 48.6 % completed the study , respectively .
RESULTS	No significant differences were observed between any outcomes .
RESULTS	Median [ interquartile range ( IQR ) ] weight change was EC : -1.1 ( 9.5 ) kg versus SC : -1.1 ( 7.5 ) kg ( 6 weeks to 6 months ) and EC : +1.0 ( 8.7 ) kg versus SC : +2.3 ( 9 ) kg ( prepregnancy to 6 months ) .
RESULTS	Intervention women breastfed for half a month longer than control women ( 180 versus 164 days ; P = 0.10 ) .
RESULTS	An average of 2.3 out of six activity sheets per participant was returned .
CONCLUSIONS	Despite low intervention engagement , the high retention rate suggests this remains an area of interest to women .
CONCLUSIONS	Future strategies must facilitate women 's engagement , be individually tailored , and include features that support behaviour change to decrease women 's risk of chronic health issues .

###25127325
OBJECTIVE	The aim of the present study was to compare two novel fine structure strategies `` FS4 '' and `` FS4-p '' with the established fine structure processing ( FSP ) strategy .
OBJECTIVE	FS4 provides fine structure information on the apical four-electrode channels .
OBJECTIVE	With FS4-p , these electrodes may be stimulated in a parallel manner .
OBJECTIVE	The authors evaluated speech perception , sound quality , and subjective preference .
METHODS	A longitudinal crossover study was done on postlingually deafened adults ( N = 33 ) who were using FSP as their default strategy .
METHODS	Each participant was fitted with FS4 , FS4-p , and FSP , for 4 months in a randomized and blinded order .
METHODS	After each run , an Adaptive Sentence test in noise ( Oldenburger Sentence Test [ OLSA ] ) and a Monosyllable test in quiet ( Freiburger Monosyllables ) were performed , and subjective sound quality was determined with a Visual Analogue Scale .
METHODS	At the end of the study the preferred strategy was noted .
RESULTS	Scores of the OLSA did not reveal any significant differences among the three strategies , but the Freiburger test showed a statistically significant effect ( p = 0.03 ) with slightly worse scores for FS4 ( 49.7 % ) compared with FSP ( 54.3 % ) .
RESULTS	Performance of FS4-p ( 51.8 % ) was comparable with the other strategies .
RESULTS	Both audiometric tests depicted a high variability among subjects .
RESULTS	The number of best-performing strategies for each participant individually was as follows : ( a ) for the OLSA : FSP , N = 10.5 ; FS4 , N = 10.5 ; and FS4-p , N = 12 ; and ( b ) for the Freiburger test : FSP , N = 14 ; FS4 , N = 9 ; and FS4-p , N = 10 .
RESULTS	A moderate agreement was found in the best-performing strategies of the Speech tests within the participants .
RESULTS	For sound quality , speech in quiet , classical , and pop music were assessed .
RESULTS	No significant effects of strategy were found for speech in quiet and classical music , but auditory impression of pop music was rated as more natural in FSP compared with FS4 ( p = 0.04 ) .
RESULTS	It is interesting that at the end of the study , a majority of the participants favored the new coding strategies over their previous default FSP ( FSP , N = 13 ; FS4 , N = 13 ; FS4-p , N = 7 ) .
CONCLUSIONS	In summary , FS4 and FS4-p offer new and further options in audio processor fitting , with similar levels of speech understanding in noise as FSP .
CONCLUSIONS	This is an interesting result , given that the strategies ' presentation of temporal fine structure differs from FSP .
CONCLUSIONS	At the end of the study , 20 of 33 subjects chose either FS4 or FS4-p over their previous default strategy FSP .

###25127927
BACKGROUND	While alcohol intoxication is known to increase disinhibited behavior , the degree to which disinhibition occurs appears to depend on a number of factors including executive functioning ability .
BACKGROUND	However , the neural mechanisms by which individual differences in executive functioning lead to variable degrees of disinhibition remain unclear .
OBJECTIVE	The aim of the current study was to examine the neural mechanisms by which individual differences in working memory ( WM ) capacity moderate alcohol-induced disinhibition .
METHODS	Seventeen heavy-drinking males participated in a within-subjects design in which two sessions were completed : an alcohol session ( .82 g/kg ) and a control session .
METHODS	Participants completed a go/no-go task while undergoing functional magnetic resonance imaging ( fMRI ) after ingestion of the control or alcohol beverage .
METHODS	WM capacity was measured using an operation span task .
RESULTS	Significant interactions of session and WM capacity emerged in contrasts examining successful response inhibition within superior temporal gyrus and unsuccessful inhibition in regions within the default mode network .
RESULTS	In all cases , individuals with low WM capacity demonstrated a relative decrease in blood oxygen level-dependent ( BOLD ) response during the alcohol compared to control session , whereas the high-WM-capacity group demonstrated relative increases in BOLD response in the alcohol compared to control session .
CONCLUSIONS	Low WM capacity appears to be associated with decreased neural response to signals indicating a need for behavioral control , an effect that may lead to increased difficulty with inhibiting responses and increased negative consequences from alcohol intoxication .

###24935755
BACKGROUND	Individuals with substance use disorders ( SUDs ) experience increased smoking-related morbidity and mortality but severely compromised smoking treatment benefits .
BACKGROUND	Residential SUD treatment settings may be particularly positioned to target smoking , with ever-increasing smoking bans and culture shifts , but most smokers continue smoking .
BACKGROUND	This study examined the effects of contingency management ( CM ) for increasing smoking abstinence in residential patients .
METHODS	Smokers interested in quitting were recruited from a residential SUD program for men and were randomized to frequent smoking monitoring with behavioral support ( monitoring ; n = 21 ) or that plus smoking abstinence-contingent ( expired carbon monoxide [ CO ] 6 ppm ; urinary cotinine 30ng/ml ) incentives ( CM , n = 24 ) for 4 weeks .
METHODS	After setting a quit date , procedures included daily behavioral support and smoking self-reports , 2 CO samples ( a.m. / p.m. ) Monday through Friday , and cotinine tests on Mondays .
METHODS	CM participants received escalating draws for prizes ( $ 1 , $ 20 , and $ 100 values ) for negative tests ; positive and missed samples reset draws .
METHODS	Follow-ups involved samples , self-reported smoking , and self-efficacy ( weeks 4 , 8 , 12 , and 24 ) .
RESULTS	Percent days CO-negative was higher with CM ( median [ interquartile range ] 51.7 % [ 62.8 % ] ) compared to monitoring ( 0 % [ 32.1 % ] ) ( p = .002 ) .
RESULTS	Cigarettes per day declined and point-prevalence abstinence increased through follow-up ( p < .01 ) , without significant group by time effects ( p > .05 ) .
RESULTS	Abstinence self-efficacy increased overall during the intervention and more with CM compared to monitoring and was associated with abstinence across conditions through follow-up .
CONCLUSIONS	CM improved some measures of response to smoking treatment in residential SUD patients .

###24483110
OBJECTIVE	To observe the efficacy of Jianbu Tongluo Xunzheng Liquid ( JTXL ) in treating knee osteoarthritis ( KOA ) , and to explore the correlation between changes of infrapatellar fat pad scanned by CT and the efficacy .
METHODS	Totally 105 KOA outpatients were randomly assigned to three groups , i.e. , the treatment group , the control group , and the combination group , 35 in each group .
METHODS	Patients in the treatment group were fumigated by JTXL , 30 min each time , once daily , 10 times as a course of treatment , 3 courses in total .
METHODS	Those in the control group received intra-articular injection of Sodium Hyaluronate Injection ( SHI ) , 3 mL each time , once per 6 days , 5 times in total .
METHODS	Those in the combination group were treated by fumigation of JTXL + intra-articular injection of SHI in the same way as the aforesaid two groups .
METHODS	All patients were treated for 30 days .
METHODS	Their clinical efficacy and changes of infrapatellar fat pad scanned by CT were observed , and their correlation was analyzed .
RESULTS	The total effective rate was 88.57 % in the combination group , better than that of the control group ( 74.29 % ) and the treatment group ( 80.00 % ; both P < 0.05 ) .
RESULTS	Besides , the score for knee joint functions at Hospital for Special Surgery ( HSS ) was better in the combination group than the other two groups ( P < 0.05 ) .
RESULTS	The anteroposterior diameter , exterior-interior diameter , the superior-inferior diameter were shortened , and the density decreased in the treatment group and the combination group ( P < 0.05 ) .
RESULTS	Besides , they were superior to those of the control group ( P < 0.05 ) .
CONCLUSIONS	Changes of infrapatellar fat pad scanned by CT only existed in the combination group and the treatment group , indicating changes of CT scanning was only correlated with effect on changing physicochemical properties of infrapatellar fat pad .
CONCLUSIONS	Treatment by Chinese medicine could omnipotently and balanced regulate functions and structures of every tissue .
CONCLUSIONS	Therefore , CT could be taken as a better method for clinical efficacy observation by Chinese medicine .

###24446955
OBJECTIVE	To evaluate therapeutic efficacy upon augmenting the initial communication to patients regarding the diagnosis of psychogenic nonepileptic seizures ( PNES ) with a novel , brief group psychoeducation administered by the same team that provided the video-electroencephalography ( VEEG ) confirmed diagnosis and within 4 weeks of the diagnosis .
METHODS	Prior to discharge from the epilepsy monitoring unit ( EMU ) , a standardized communication strategy was utilized to explain the diagnosis of PNES to all patients prior to enrollment .
METHODS	Enrolled patients were then randomized to either participation in three successive and monthly group psychoeducational sessions ( intervention group ) , or routine seizure clinic follow-up visits ( control group ) .
METHODS	Both groups completed questionnaires at time of enrollment , and then at approximately 3 months ( follow-up 1 ) and 6 months ( follow-up 2 ) after discharge , assessing for : ( 1 ) primary outcomes that include a measure of psychosocial functioning , as well as interval difference in seizure frequency/intensity ; and ( 2 ) secondary outcomes that include interval seizure-related emergency room visits or hospitalizations , development of new and medically unexplained symptoms , and results of an internal measure of knowledge and perception outcomes .
RESULTS	The majority ( 73 % ) of patients from the intervention group commenced on therapy sessions within 4 weeks after learning of the diagnosis .
RESULTS	Although we did not observe significant group difference in seizure frequency/intensity , patients from the intervention group showed significant improvement on the Work and Social Adjustment Scale ( WSAS ) scores at both follow-up 1 ( p = 0.013 ) and follow-up 2 ( p = 0.038 ) after discharge from the EMU .
RESULTS	In addition , we observed a trend toward lesser likelihood for seizure-related emergency room visits or hospitalizations for the intervention group ( p = 0.184 ) , as well as meaningful insights from an internal measure of intervention outcomes .
CONCLUSIONS	These findings suggest that our cost/resource effective , brief group psychoeducational program , when administered early and by the same team who confirmed and communicated the diagnosis of PNES , may contribute to significant functional improvement among participating patients .

###24521088
BACKGROUND	Few studies have considered the retention of the individuals ( alters ) comprising the social networks of people in recovery .
OBJECTIVE	The purpose of this study was to describe factors predicting whether alters were retained 6 months after participants completed treatment .
METHODS	The Important Person Inventory was given to 270 ex-offenders ( 224 men , 46 women ) transitioning from treatment to Oxford House residences , Safe Haven therapeutic communities , or to usual aftercare .
METHODS	A 6-month follow-up was completed by 176 participants ( 137 men , 39 women ) .
RESULTS	We found that alters who were related to the participant , did not use drugs , were embedded in smaller networks , and had more frequent contact with the participant were significantly more likely to be retained as important people over 6 months .
RESULTS	The alters ' drinking and criminal history were not significantly predictive of retention in the network .
CONCLUSIONS	Certain characteristics of important people are related to their retention in a social network .
CONCLUSIONS	Understanding these relationships and the extent to which the network change that occurs is aligned with abstinence-supporting networks is essential for creating effective social interventions for persons in recovery .

###25023711
METHODS	A clinical randomized controlled trial .
OBJECTIVE	This study sought to compare the clinical effectiveness of CT-guided nucleoplasty , CT-guided nucleoplasty combined with nerve root injection , and CT-guided transforaminal lumbar epidural injections in treating patients with contained lumbar disk herniation and leg pain , which are caused by radicular encroachment .
BACKGROUND	Lumbar disk herniation is the most common cause of nerve root pain .
BACKGROUND	The conservative treatment is proved to be effective for the majority of these patients , and the remaining patients are not ideal surgical candidates .
BACKGROUND	Studies have found that minimally invasive percutaneous disk procedures may be preferable to open surgery in certain clinical situations .
BACKGROUND	However , nucleoplasty in treating contained lumbar disk herniation and leg pain caused by radicular encroachment is still a controversy .
METHODS	A total of 97 patients with leg pain and MRI evidence of small-sized or medium-sized herniated disks correlating with the symptoms participated in the study .
METHODS	The patients were randomly allocated into 3 groups : the CT-guided nucleoplasty group ( N = 33 ) , the CT-guided nucleoplasty with nerve root injection group ( N = 35 ) , and CT-guided transforaminal lumbar epidural injections group ( N = 29 ) .
METHODS	Numeric Rating Scale ( NRS ) pain score and Oswestry Disability Index ( ODI ) values were applied at pretreatment and 1 week , 1 month , 3 months , and 12 months at posttreatment .
RESULTS	There were statistically significant decreases ( P = 0.000 ) in the NRS and ODI scores for all posttreatment time points when compared with the pretreatment values in all the 3 groups .
RESULTS	The average NRS and ODI results for the transforaminal lumbar epidural injections group were significantly higher than those for the other 2 groups at 3 and 12 months posttreatment ( P < 0.05 ) .
RESULTS	The combination of nucleoplasty with nerve root injection produced a significantly greater reduction in the NRS and ODI scores when compared with nucleoplasty at 1 week ( P = 0.000 for NRS and P = 0.004 for ODI ) and 1 month ( P = 0.000 for NRS and P = 0.007 for ODI ) after the treatment .
CONCLUSIONS	The results of this study suggest that CT-guided nucleoplasty with radiofrequency energy is a relative effective and safe technique for treating leg pain caused by radicular encroachment .
CONCLUSIONS	Furthermore , nucleoplasty combined with nerve root injection had achieved a significant greater improvement in pain management and functional level in short term ( within 1 mo ) after treatment than nucleoplasty alone .

###25179366
BACKGROUND	Endovascular or intra-arterial treatment ( IAT ) increases the likelihood of recanalization in patients with acute ischemic stroke caused by a proximal intracranial arterial occlusion .
BACKGROUND	However , a beneficial effect of IAT on functional recovery in patients with acute ischemic stroke remains unproven .
BACKGROUND	The aim of this study is to assess the effect of IAT on functional outcome in patients with acute ischemic stroke .
BACKGROUND	Additionally , we aim to assess the safety of IAT , and the effect on recanalization of different mechanical treatment modalities .
METHODS	A multicenter randomized clinical trial with blinded outcome assessment .
METHODS	The active comparison is IAT versus no IAT .
METHODS	IAT may consist of intra-arterial thrombolysis with alteplase or urokinase , mechanical treatment or both .
METHODS	Mechanical treatment refers to retraction , aspiration , sonolysis , or use of a retrievable stent ( stent-retriever ) .
METHODS	Patients with a relevant intracranial proximal arterial occlusion of the anterior circulation , who can be treated within 6hours after stroke onset , are eligible .
METHODS	Treatment effect will be estimated with ordinal logistic regression ( shift analysis ) ; 500 patients will be included in the trial for a power of 80 % to detect a shift leading to a decrease in dependency in 10 % of treated patients .
METHODS	The primary outcome is the score on the modified Rankin scale at 90days .
METHODS	Secondary outcomes are the National Institutes of Health stroke scale score at 24hours , vessel patency at 24hours , infarct size on day 5 , and the occurrence of major bleeding during the first 5days .
CONCLUSIONS	If IAT leads to a 10 % absolute reduction in poor outcome after stroke , careful implementation of the intervention could save approximately 1 % of all new stroke cases from death or disability annually .
BACKGROUND	NTR1804 ( 7 May 2009 ) / ISRCTN10888758 ( 24 July 2012 ) .

###24838401
BACKGROUND	Listening to music is a low-cost intervention that has demonstrated ability to reduce pain and anxiety levels in various medical procedures .
METHODS	Subjects undergoing electrophysiological examinations were randomized into a music-listening group and a control group .
METHODS	Visual analog scales were used to measure anxiety and pain levels during the procedure .
RESULTS	Thirty subjects were randomized to each group .
RESULTS	No statistically significant difference was found in anxiety or pain levels during the procedure between groups .
RESULTS	However , most subjects in the music-listening group reported anxiety and pain reduction and would prefer to hear music in a future examination .
CONCLUSIONS	Although listening to music during electrophysiological examinations did not reduce anxiety or pain significantly , most subjects felt a positive effect and would prefer to hear music ; therefore , we suggest that music may be offered optionally in the electromyography laboratory setting .

###25524339
BACKGROUND	The incidence and prognostic impact of late bleeding complications after transcatheter aortic valve replacement ( TAVR ) are unknown .
OBJECTIVE	The aim of this study was to identify the incidence , predictors , and prognostic impact of major late bleeding complications ( MLBCs ) ( 30 days ) after TAVR .
METHODS	Clinical and echocardiographic outcomes of patients who underwent TAVR within the randomized cohorts and continued access registries in the PARTNER ( Placement of Aortic Transcatheter Valves ) trial were analyzed after stratifying by the occurrence of MLBCs .
METHODS	Predictors of MLBCs and their association with 30-day to 1-year mortality were assessed .
RESULTS	Among 2,401 patients who underwent TAVR and survived to 30 days , MLBCs occurred in 142 ( 5.9 % ) at a median time of 132 days ( interquartile range : 71 to 230 days ) after the index procedure .
RESULTS	Gastrointestinal complications ( n = 58 [ 40.8 % ] ) , neurological complications ( n = 22 [ 15.5 % ] ) , and traumatic falls ( n = 11 [ 7.8 % ] ) were identified as the most frequent types of MLBCs .
RESULTS	Independent predictors of MLBCs were the presence of low hemoglobin at baseline , atrial fibrillation or flutter at baseline or 30 days , the presence of moderate or severe paravalvular leak at 30 days , and greater left ventricular mass at 30 days .
RESULTS	MLBCs were identified as a strong independent predictor of mortality between 30 days and 1 year ( adjusted hazard ratio : 3.91 ; 95 % confidence interval : 2.67 to 5.71 ; p < 0.001 ) .
CONCLUSIONS	MLBCs after TAVR were frequent and associated with increased mortality .
CONCLUSIONS	Better individualized and risk-adjusted antithrombotic therapy after TAVR is urgently needed in this high-risk population .
CONCLUSIONS	( THE PARTNER TRIAL : Placement of AoRTic TraNscathetER Valve Trial ; NCT00530894 ) .

###24493633
OBJECTIVE	Phonemic verbal fluency ( PVF ) is a cognitive function that involves serial processes termed clustering and switching and which is impacted in both normal aging and dementia .
OBJECTIVE	The cognitive reserve hypothesis suggests that appropriate cognitive stimulation could maintain or improve cognitive performance .
OBJECTIVE	This study examines the effect on PVF performance of a brief crossword-based intervention in a cognitively normal , community-based sample .
METHODS	Thirty-seven members of active retirement groups volunteered to participate and were randomly assigned to a crossword group and a control group .
METHODS	The former attempted a crossword daily for 4weeks while the latter kept a daily gratitude diary for the same period .
RESULTS	22 mixed analyses of variance revealed that the crossword group performed significantly better over time than the control group in both total PVF score and in the cluster size component .
CONCLUSIONS	Daily crosswords may be a simple and effective means of bolstering PVF performance in older people .

###24314875
OBJECTIVE	Metabolic syndrome and depression seem to share some common underlying mechanisms , although less is known about the impact of metabolic syndrome dietary treatments on depression .
OBJECTIVE	This study examined the association between a hypocaloric treatment designed to reduce metabolic syndrome features in self-perceived depression and the potential involvement of dietary components and oxidative stress changes .
METHODS	Analyses were based on volunteers ( n = 55 ) with metabolic syndrome ( age 50 1 y.o. ; 38M/17F ) , where depressive symptoms were assessed using the Beck Depression Inventory .
METHODS	Participants followed two hypocaloric diets ( control diet and RESMENA diet ) with the same energy restriction ( -30 % TCV ) for six months .
METHODS	Depressive symptoms , dietary records , anthropometrical measurements , biochemical parameters and oxidative stress levels were analysed .
RESULTS	Both diets improved self-perceived depression similarly ( p = 0.528 ) .
RESULTS	Participants with lower depressive symptoms at baseline reported a significantly higher intake of omega-3 polyunsaturated fatty acids ( p trend = 0.002 ) .
RESULTS	Interestingly , after adjusting for potential confounders , the increase in folate consumption ( p = 0.011 ) and the decrease in plasma malondialdehyde levels ( p = 0.012 ) throughout the intervention , were associated with the improvement in depressive symptoms .
CONCLUSIONS	A higher intake of folate and a decline in malondialdehyde plasma levels during a weight loss intervention , were related to improvements in manifestations of depression ( www.clinicaltrials.gov ; NCT01087086 ) .

###24379592
OBJECTIVE	To investigate the effect of somatostatin and dexamethasone on early postoperative small bowel obstruction with obliterative peritonitis ( EPSBO-OP ) .
METHODS	This prospective randomized study included 70 patients diagnosed with EPSBO-OP from June 2002 to January 2009 .
METHODS	Patients were randomized into two groups : a control group received total parenteral nutrition and nasogastric ( NG ) tube feeding ; and an intervention group received , in addition , somatostatin and dexamethasone treatment .
METHODS	The primary endpoints were time to resolution of bowel obstruction and length of hospital stay , and the secondary endpoints were daily NG output and NG feeding duration , treatment-related complications , postoperative obstruction relapse , and patient satisfaction .
RESULTS	Thirty-six patients were allocated to the intervention group and 34 to the control group .
RESULTS	No patient needed to undergo surgery .
RESULTS	Patients in the intervention group had an earlier resolution of bowel obstruction ( 22.4 9.1 vs 29.9 10.1 d , P = 0.002 ) .
RESULTS	Lower daily NG output ( 583 208 vs 922 399 mL/d , P < 0.001 ) , shorter duration of NG tube use ( 16.7 8.8 vs 27.7 9.9 d , P < 0.001 ) , and shorter length of hospital stay ( 25.8 vs 34.9 d , P = 0.001 ) were observed in the intervention group .
RESULTS	The rate of treatment-related complications ( P = 0.770 ) and relapse of obstruction ( P = 0.357 ) were comparable between the two groups .
RESULTS	There were no significant differences in postoperative satisfaction at 1 , 2 and 3 years between the two groups .
CONCLUSIONS	Somatostatin and dexamethasone for EPSBO-OP promote resolution of obstruction and shorten hospital stay , and are safe for symptom control without increasing obstruction relapse .

###24261335
BACKGROUND	Despite the health risks , physical inactivity is common .
BACKGROUND	Identifying the correlates of physical activity to inform the design of interventions to reduce the disease burden associated with physical inactivity is a public health imperative .
BACKGROUND	Rural adults have a unique set of characteristics influencing their activity behaviour , and are typically understudied , especially in England .
BACKGROUND	The aim of this study was to identify the personal , social , and environmental correlates of physical activity in adults living in rural villages .
METHODS	The study used baseline data from 2415 adults ( response rate : 37.7 % ) participating in the first time period of a stepped-wedge cluster randomised trial , conducted in 128 rural villages from south-west England .
METHODS	Data collected included demographic characteristics , social factors , perception of the local environment , village level factors ( percentage male , mean age , population density , Index of Multiple Deprivation , and sport market segmentation ) , and physical activity behaviour .
METHODS	Random effects ( `` multilevel '' ) logistic regression models were fitted to the binary outcome whether individuals met physical activity guidelines , and random effects linear regression models were fitted to the continuous outcome MET-minutes per week leisure time physical activity , using the personal , social , environmental , and village-level factors as predictors .
RESULTS	The following factors both increased the odds of meeting the recommended activity guidelines and were associated with more leisure-time physical activity : being male ( p = 0.002 ) , in good health ( p < 0.001 ) , greater commitment to being more active ( p = 0.002 ) , favourable activity social norms ( p = 0.004 ) , greater physical activity habit ( p < 0.001 ) , and recent use of recreational facilities ( p = 0.01 ) .
RESULTS	In addition , there was evidence ( p < 0.05 ) that younger age , lower body mass index , having a physical occupation , dog ownership , inconvenience of public transport , and using recreational facilities outside the local village were associated with greater reported leisure-time physical activity .
RESULTS	None of the village-level factors were associated with physical activity .
CONCLUSIONS	This study adds to the current literature on the correlates of physical activity behaviour by focusing on a population exposed to unique environmental conditions .
CONCLUSIONS	It highlights potentially important correlates of physical activity that could be the focus of interventions targeting rural populations , and demonstrates the need to examine rural adults separately from their urban counterparts .

###24432995
BACKGROUND	Living in a prediabetes state significantly increases a patient 's risk for both diabetes and cardiovascular disease .
BACKGROUND	Tianqi capsule , containing 10 Chinese herbal medicines , is used in China for the treatment of type 2 diabetes mellitus ( T2DM ) .
OBJECTIVE	The purpose of this study was to assess whether Tianqi prevented T2DM in subjects with impaired glucose tolerance ( IGT ) over the course of a 12-month treatment .
METHODS	Individuals with IGT were randomly allocated in a double-blind manner to receive Tianqi ( n = 210 ) or a placebo ( n = 210 ) for 12 months .
METHODS	Oral glucose tolerance tests were conducted every 3 months to assess the development of diabetes or restoration to normal glucose tolerance .
METHODS	All subjects received the same lifestyle education .
METHODS	The primary endpoint was the conversion of IGT to T2DM .
METHODS	Body weight and body mass index were observed .
METHODS	Adverse effects were monitored .
RESULTS	Of the 420 enrolled subjects with IGT , 389 completed the trial ( 198 in the Tianqi group and 191 in the placebo group ) .
RESULTS	At the end of the 12-month trial , 36 subjects in the Tianqi group ( 18.18 % ) and 56 in the placebo group ( 29.32 % ) had developed diabetes ( P = .01 ) .
RESULTS	There was a significant difference in the number of subjects who had normal glucose tolerance at the end of the study between the Tianqi and placebo groups ( n = 125 , 63.13 % , and n = 89 , 46.60 % , respectively ; P = .001 ) .
RESULTS	Cox 's proportional hazards model analysis showed that Tianqi reduced the risk of diabetes by 32.1 % compared with the placebo .
RESULTS	No severe adverse events occurred in the trial .
RESULTS	There were no statistical differences in body weight and body mass index changes between the Tianqi group and the placebo group during the 12-month trial .
CONCLUSIONS	Treatment with a Tianqi capsule for 12 months significantly decreased the incidence of T2DM in subjects with IGT , and this herbal drug was safe to use .

###24879494
OBJECTIVE	Orthostatic hypotension commonly accompanies supine hypertension , and is associated with low 25-hydroxyvitamin D levels .
OBJECTIVE	We tested whether high-dose intermittent oral vitamin D therapy could ameliorate orthostatic hypotension in older patients with isolated systolic hypertension .
METHODS	We conducted a subgroup analysis of data from a parallel-group , double-blind , randomized , placebo-controlled trial .
METHODS	Patients aged over 70 years with supine office SBP above 140mmHg and DBP below 90mmHg received 100000 units oral vitamin D3 or matching placebo every 3 months for 1 year .
METHODS	Office supine and standing blood pressure were measured at baseline , and 3 , 6 , 9 and 12 months , along with arterial stiffness and flow-mediated dilatation of the brachial artery .
RESULTS	Of 159 patients randomized to the main trial , 75 patients with orthostatic hypotension at baseline were included in this analysis .
RESULTS	The mean age was 78 ( SD 5 ) years , baseline blood pressure was 162/76mmHg and the mean baseline orthostatic fall in blood pressure on standing was 32/5mmHg .
RESULTS	After adjustment for baseline age , 25-hydroxyvitamin D , SBP and orthostatic fall , the fall in SBP was less in the vitamin D group at 3 months [ treatment effect 6mmHg , 95 % confidence interval ( CI ) 0 to 12 ] , but repeated-measures analysis showed no significant treatment effect ( 3mmHg for systolic fall , 95 % CI -1 to 8 ; 1mmHg for diastolic fall , 95 % CI -1 to 3 ) .
CONCLUSIONS	Twelve months of intermittent , high-dose oral vitamin D3 did not significantly improve orthostatic hypotension in older patients with isolated systolic hypertension .

###24726614
OBJECTIVE	Early prediction of the expected benefit of treatment in recurrent ovarian cancer ( ROC ) patients may help in drug development decisions .
OBJECTIVE	The actual value of 50 % CA-125 decrease is being reconsidered .
OBJECTIVE	The main objective of the present study was to quantify the links between longitudinal assessments of CA-125 kinetics and progression-free survival ( PFS ) in treated recurrent ovarian cancer ( ROC ) patients .
METHODS	The CALYPSO randomized phase III trial database comparing two platinum-based regimens in ROC patients was randomly split into a `` learning dataset '' and a `` validation dataset '' .
METHODS	A parametric survival model was developed to associate longitudinal modeled CA-125 changes ( CA125 ) , predictive factors , and PFS .
METHODS	The predictive performance of the model was evaluated with simulations .
RESULTS	The PFS of 534 ROC patients were properly characterized by a parametric mathematical model .
RESULTS	The modeled CA125 from baseline to week 6 was a better predictor of PFS than the modeled fractional change in tumor size .
RESULTS	Simulations confirmed the model 's predictive performance .
CONCLUSIONS	We present the first parametric survival model quantifying the relationship between PFS and longitudinal CA-125 kinetics in treated ROC patients .
CONCLUSIONS	The model enabled calculation of the increase in CA125 required to observe a predetermined benefit in PFS to compare therapeutic strategies in populations .
CONCLUSIONS	Therefore , CA125 may be a predictive marker of the expected gain in PFS and an early predictive tool in drug development decisions .

###25301459
BACKGROUND	Drug-eluting balloons ( DEB ) may reduce infrapopliteal restenosis and reintervention rates versus percutaneous transluminal angioplasty ( PTA ) and improve wound healing/limb preservation .
OBJECTIVE	The goal of this clinical trial was to assess the efficacy and safety of IN.PACT Amphirion drug-eluting balloons ( IA-DEB ) compared to PTA for infrapopliteal arterial revascularization in patients with critical limb ischemia ( CLI ) .
METHODS	Within a prospective , multicenter , randomized , controlled trial with independent clinical event adjudication and angiographic and wound core laboratories 358 CLI patients were randomized 2:1 to IA-DEB or PTA .
METHODS	The 2 coprimary efficacy endpoints through 12 months were clinically driven target lesion revascularization ( CD-TLR ) and late lumen loss ( LLL ) .
METHODS	The primary safety endpoint through 6 months was a composite of all-cause mortality , major amputation , and CD-TLR .
RESULTS	Clinical characteristics were similar between the 2 groups .
RESULTS	Significant baseline differences between the IA-DEB and PTA arms included mean lesion length ( 10.2 cm vs. 12.9 cm ; p = 0.002 ) , impaired inflow ( 40.7 % vs. 28.8 % ; p = 0.035 ) , and previous target limb revascularization ( 32.2 % vs. 21.8 % ; p = 0.047 ) .
RESULTS	Primary efficacy results of IA-DEB versus PTA were CD-TLR of 9.2 % versus 13.1 % ( p = 0.291 ) and LLL of 0.61 0.78 mm versus 0.62 0.78 mm ( p = 0.950 ) .
RESULTS	Primary safety endpoints were 17.7 % versus 15.8 % ( p = 0.021 ) and met the noninferiority hypothesis .
RESULTS	A safety signal driven by major amputations through 12 months was observed in the IA-DEB arm versus the PTA arm ( 8.8 % vs. 3.6 % ; p = 0.080 ) .
CONCLUSIONS	In patients with CLI , IA-DEB had comparable efficacy to PTA .
CONCLUSIONS	While primary safety was met , there was a trend towards an increased major amputation rate through 12 months compared to PTA .
CONCLUSIONS	( Study of IN.PACT Amphirion Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia [ INPACT-DEEP ] ; NCT00941733 ) .

###25602863
OBJECTIVE	We tested the efficacy of a minimal intervention to create smoke-free homes in low-income households recruited through the United Way of Greater Atlanta 2-1-1 , an information and referral system that connects callers to local social services .
METHODS	We conducted a randomized controlled trial ( n = 498 ) from June 2012 through June 2013 , with follow-up at 3 and 6 months .
METHODS	The intervention consisted of 3 mailings and 1 coaching call .
RESULTS	Participants were mostly smokers ( 79.7 % ) , women ( 82.7 % ) , African American ( 83.3 % ) , and not employed ( 76.5 % ) , with an annual household income of $ 10,000 or less ( 55.6 % ) .
RESULTS	At 6-months postbaseline , significantly more intervention participants reported a full ban on smoking in the home than did control participants ( 40.0 % vs 25.4 % ; P = .002 ) .
RESULTS	The intervention worked for smokers and nonsmokers , as well as those with or without children .
CONCLUSIONS	Minimal intervention was effective in promoting smoke-free homes in low income households and offers a potentially scalable model for protecting children and adult nonsmokers from secondhand smoke exposure in their homes .

###24596911
OBJECTIVE	This clinical trial evaluated the influence of denture adhesive ( DA ) use on masticatory function in denture wearers according to their denture-bearing ridge status .
METHODS	Thirty edentulous subjects , wearing new well-fitting dentures , were classified as having either a normal or resorbed ridge .
METHODS	Mastication was evaluated in patients who completed chewing tests with and without two DA substances ( cream or strips ) , which were randomly assigned .
METHODS	A chewing test with a sieve method analyzed masticatory performance .
METHODS	A kinesiographic device evaluated chewing cycle , and a visual analog scale measured masticatory ability .
METHODS	Data were submitted to Mauchly 's sphericity test , and PROC MIXED procedures were conducted on repeated measures .
METHODS	Tukey-Kramer tests performed appropriate statistical comparisons ( P .05 ) .
RESULTS	DA use increased masticatory performance and ability in patients with both ridge types ( P < .05 ) .
RESULTS	Subjects with resorbed ridges showed the best masticatory performance ( P < .001 ) and lowest chewing cycle time ( P < .001 ) with DA cream , followed by DA strips and the nonadhesive trial .
RESULTS	For normal ridge subjects , decreases in 50 values were only significant with DA use ( P < .05 ) , regardless of DA type .
RESULTS	The denture-bearing ridge status alone did not alter masticatory function in any of the parameters evaluated .
CONCLUSIONS	DAs improve mastication by shortening the chewing cycle and by enhancing chewing ability and performance .

###24263042
OBJECTIVE	We aimed to investigate the effect of 21 % and 40 % oxygen supplementation on maternal and neonatal oxidative stress in elective cesarean section ( CS ) under spinal anesthesia .
METHODS	Eighty term parturients undergoing elective CS under spinal anesthesia were enrolled in the study .
METHODS	We allocated patients randomly to breathe 21 % ( air group ) or 40 % ( oxygen group ) oxygen from the time of skin incision until the end of the operation .
METHODS	We collected maternal pre - and post-operative and umbilical artery ( UA ) blood samples .
METHODS	Total antioxidant capacity ( TAC ) , total oxidant status ( TOS ) and the oxidative stress index ( OSI ) were measured .
RESULTS	Age , weight , height , parity , gestation week , spinal-skin incision time , skin incision-delivery time , delivery time , operation time , 1st and 5th minutes Apgar scores , and birth weight were similar between the groups ( p > 0.05 for all comparisons ) .
RESULTS	There were no differences in preoperative TAC , TOS , or OSI levels between the groups ( p > 0.05 for all comparisons ) .
RESULTS	Postoperative maternal TAC , TOS and OSI levels significantly increased in the oxygen group ( p = 0.047 , < 0.001 and 0.038 , respectively ) ; umbilical artery TAC levels significantly increased in the oxygen group ( p = 0.003 ) ; and umbilical artery TOS and OSI levels significantly increased in the air group ( p = 0.02 and < 0.001 , respectively ) .
CONCLUSIONS	The difference in impact on maternal and fetal oxidative stress of supplemental 40 % compared to 21 % oxygen mandates further large-scale studies that investigate the role of oxygen supplementation during elective CS under spinal anesthesia .

###25474490
OBJECTIVE	It is important to distinguish children with different levels of severity of obstructive sleep apnea syndrome ( OSAS ) preoperatively using clinical parameters .
OBJECTIVE	This can identify children who most need polysomnography ( PSG ) prior to adenotonsillectomy ( AT ) .
OBJECTIVE	To assess whether a combination of factors , including demographics , physical examination findings , and caregiver reports from questionnaires , can predict different levels of OSAS severity in children .
METHODS	Baseline data from 453 children from the Childhood Adenotonsillectomy ( CHAT ) study were analyzed .
METHODS	Children 5.0 to 9.9 years of age with PSG-diagnosed OSAS , who were considered candidates for AT , were included .
METHODS	Polysomnography for diagnosis of OSAS .
METHODS	Linear or logistic regression models were fitted to identify which demographic , clinical , and caregiver reports were significantly associated with the apnea hypopnea index ( AHI ) and oxygen desaturation index ( ODI ) .
RESULTS	Race ( African American ) , obesity ( body mass index z score > 2 ) , and the Pediatric Sleep Questionnaire ( PSQ ) total score were associated with higher levels of AHI and ODI ( P = .05 ) .
RESULTS	A multivariable model that included the most significant variables explained less than 3 % of the variance in OSAS severity as measured by PSG outcomes .
RESULTS	Tonsillar size and Friedman palate position were not associated with increased AHI or ODI .
RESULTS	Models that tested for potential effect modification by race or obesity showed no evidence of interactions with any clinical measure , AHI , or ODI ( P > .20 for all comparisons ) .
CONCLUSIONS	This study of more than 450 children with OSAS identifies a number of clinical parameters that are associated with OSAS severity .
CONCLUSIONS	However , information on demographics , physical findings , and questionnaire responses does not robustly discriminate different levels of OSAS severity .
BACKGROUND	clinicaltrials.gov Identifier : NCT00560859 .

###24521771
BACKGROUND	In a phase III , open-label , comparative , noninferiority study , 638 subjects receiving de novo kidney transplants were randomized to one of three treatment arms : tacrolimus extended-release ( Astagraf XL ) qd , tacrolimus ( Prograf ) bid , or cyclosporine ( CsA ) bid .
BACKGROUND	All subjects received basiliximab induction , mycophenolate mofetil , and corticosteroids .
BACKGROUND	Safety and efficacy follow-up data through 4 years are reported .
METHODS	Evaluations included patient and graft survival , study drug discontinuations , laboratory values including renal function and development of new-onset diabetes after transplantation , concomitant medications , and adverse events .
RESULTS	At study termination , 129 Astagraf XL , 113 Prograf , and 79 CsA patients had continued follow-up .
RESULTS	Demographic and baseline characteristics were similar in all arms .
RESULTS	Four-year Kaplan-Meier estimates of patient survival in the Astagraf XL , Prograf , and CsA groups were 93.2 , 91.2 , and 91.7 % , respectively , while graft survival was 84.7 , 82.7 , and 83.9 % , respectively .
RESULTS	At least one serious adverse event was reported in the majority of patients in each group during the study ( 65.9 % Astagraf XL , 69.8 % Prograf , and 65.6 % CsA ) .
RESULTS	Renal function was not significantly different between Astagraf XL and Prograf .
RESULTS	HgbA1c levels were collected every 6 months ; the 4-year Kaplan-Meier estimate for incidence of HgbA1c levels 6.5 % was significantly higher for both tacrolimus formulations compared to CsA ; 41.1 % ( Astagraf XL ) , 33.6 % ( Prograf ) , and 21.3 % ( CsA ) .
CONCLUSIONS	In this 4-year follow-up report , patients receiving Astagraf XL and Prograf showed comparable efficacy and safety profiles , with a higher incidence of new-onset diabetes after transplantation but superior renal function compared to patients receiving CsA .

###24867571
OBJECTIVE	The objective was to identify whether it was possible to change driver behavior by economic incentives and thereby reduce crash risk .
OBJECTIVE	Furthermore , the objective was to evaluate the participants ' attitudes toward the pay-as-you-speed ( PAYS ) concept .
METHODS	A one-year PAYS trial with economic incentives for keeping speed limits using intelligent speed assistance ( ISA ) was conducted in Sweden during 2011-2012 .
METHODS	The full incentive was a 30 percent discount off the insurance premium .
METHODS	The participants were private insurance customers and were randomized into a test group ( initial n = 152 , final n = 128 ) and a control group ( initial n = 98 , final n = 68 ) .
METHODS	When driving , the drivers in the test group were informed and warned visually when the speed limit was exceeded .
METHODS	They could also follow their driving results on a personal website .
METHODS	The control group was not given any feedback at all .
METHODS	To reflect the impact of the PAYS concept the proportion of distance driven above the speed limit was compared between the 2 groups .
RESULTS	The introduction of a PAYS concept shows that the test group significantly reduced the proportion of distance driven above the speed limit .
RESULTS	The proportion of driving at a speed exceeding 5 km/h over the speed limit was 6 percent for the test group and 14 percent for the control group .
RESULTS	It also showed that the effect was higher the higher the violation of speed .
RESULTS	The result remained constant over time .
CONCLUSIONS	It was shown that a PAYS concept is an effective way to reduce speed violations .
CONCLUSIONS	Hence , it has the possibility to reduce crash severity and thereby to save lives .
CONCLUSIONS	This could be an important step toward a safer road transport system .
CONCLUSIONS	The majority of the participants were in favor of the concept , which indicates the potential of a new insurance product in the future .

###25946929
OBJECTIVE	This study aimed to evaluate the effects of vitamin D intake on COPD exacerbation and FEV1 in the patients with severe and very severe COPD .
METHODS	This double blind placebo control randomized clinical trial study was done in the Ashayer university hospital in Khorramabad in 2012 .
METHODS	Eighty eight patients with severe and very severe COPD were randomly selected from those who recoursed to the internal medicine clinic of Ashayer hospital .
METHODS	They were randomly allocated to case and placebo group .
METHODS	The patients received routine treatment for COPD .
METHODS	Along with the routine treatment , placebo group received 100,000 IU of oral vitamin D per month , for 6 months .
METHODS	Data was analyzed using SPSS computer software , paired t-test , independent t-test , non parametric t-test and Pearson correlation coefficients .
RESULTS	In each group , there were 44 patients .
RESULTS	After the intervention , there were significant differences in FEV1 and the number of COPD exacerbation between the case and control group patients .
RESULTS	Also , after the study , in the case group , FEV1 was increased and the number of COPD exacerbation was decreased significantly .
CONCLUSIONS	Vitamin D intake decreased COPD exacerbation and improved FEV1 in the patients with severe and very severe COPD .
CONCLUSIONS	It is suggested that baseline serum vitamin D levels will recorded in similar studies and the effect of vitamin D intake will evaluated regarding the baseline serum vitamin D levels .

###24299075
OBJECTIVE	Our research utilized two popular theoretical conceptualizations of implicit self-esteem : 1 ) implicit self-esteem as a global automatic reaction to the self ; and 2 ) implicit self-esteem as a context/domain specific construct .
OBJECTIVE	Under this framework , we present an extensive search for implicit self-esteem measure validity among different cultural groups ( Study 1 ) and under several experimental manipulations ( Study 2 ) .
METHODS	In Study 1 , Euro-Canadians ( N = 107 ) , Asian-Canadians ( N = 187 ) , and Japanese ( N = 112 ) completed a battery of implicit self-esteem , explicit self-esteem , and criterion measures .
METHODS	Included implicit self-esteem measures were either popular or provided methodological improvements upon older methods .
METHODS	Criterion measures were sampled from previous research on implicit self-esteem and included self-report and independent ratings .
METHODS	In Study 2 , Americans ( N = 582 ) completed a shorter battery of these same types of measures under either a control condition , an explicit prime meant to activate the self-concept in a particular context , or prime meant to activate self-competence related implicit attitudes .
RESULTS	Across both studies , explicit self-esteem measures far outperformed implicit self-esteem measures in all cultural groups and under all experimental manipulations .
CONCLUSIONS	Implicit self-esteem measures are not valid for individual or cross-cultural comparisons .
CONCLUSIONS	We speculate that individuals may not form implicit associations with the self as an attitudinal object .

###24865694
OBJECTIVE	To find a threshold body weight ( BW ) below 100 kg above which computed tomography pulmonary angiography ( CTPA ) using reduced radiation and a reduced contrast material ( CM ) dose provides significantly impaired quality and diagnostic confidence compared with standard-dose CTPA .
METHODS	In this prospectively randomised study of 501 patients with suspected pulmonary embolism and BW < 100 kg , 246 were allocated into the low-dose group ( 80 kVp , 75 ml CM ) and 255 into the normal-dose group ( 100 kVp , 100 ml CM ) .
METHODS	Contrast-to-noise ratio ( CNR ) in the pulmonary trunk was calculated .
METHODS	Two blinded chest radiologists independently evaluated subjective image quality and diagnostic confidence .
METHODS	Data were compared between the normal-dose and low-dose groups in five BW subgroups .
RESULTS	Vessel attenuation did not differ between the normal-dose and low-dose groups within each BW subgroup ( P = 1.0 ) .
RESULTS	The CNR was higher with the normal-dose compared with the low-dose protocol ( P < 0.006 ) in all BW subgroups except for the 90-99 kg subgroup ( P = 0.812 ) .
RESULTS	Subjective image quality and diagnostic confidence did not differ between CT protocols in all subgroups ( P between 0.960 and 1.0 ) .
CONCLUSIONS	Subjective image quality and diagnostic confidence with 80 kVp CTPA is not different from normal-dose protocol in any BW group up to 100 kg .
CONCLUSIONS	80 kVp CTPA is safe in patients weighing < 100 kg Reduced radiation and iodine dose still provide high vessel attenuation Image quality and diagnostic confidence with low-dose CTPA is good Diagnostic confidence does not deteriorate in obese patients weighing < 100 kg .

###24691217
OBJECTIVE	To investigate the efficacy of a two-week programme of repetitive exercise with cueing and movement strategies upon freezing of gait in people with Parkinson 's disease .
METHODS	Randomized cross-over trial .
METHODS	Specialist clinic for Parkinson 's disease .
METHODS	A total of 22 patients with Parkinson 's disease and freezing while other symptoms had favorably responded to dopaminergic treatment .
METHODS	Patients were randomized into a four-week cross-over trial , and received either treatment ( Group 1 ) or no treatment ( Group 2 ) during Period 1 , and switched during Period 2 .
METHODS	Treatment consisted of a two-week programme during which the patients exercised cueing , and movement strategies together with a physiotherapist .
METHODS	The primary outcome measure was a freezing score assessed from blinded and random ratings of video recordings .
METHODS	The secondary outcome measure was a patient-reported freezing questionnaire .
METHODS	Mean differences between the treatment periods ( treatment arms ) were evaluated for treatment ( period ) effects .
METHODS	Sums of treatment periods were evaluated for carry-over effects .
RESULTS	The programme led to a significant treatment effect in the freezing score of 3.0 improvement ( 95 % confidence interval 0.9-5 .0 ; p < 0.01 ) .
RESULTS	No carry-over or period effects were detected .
RESULTS	The questionnaire revealed a period effect , so groups were compared after Period 1 , where a significant difference was found ( 15.0 vs. 11.7 ; p < 0.05 ) .
CONCLUSIONS	The two-week physiotherapy programme reduced the severity of freezing in patients with Parkinson 's disease .

###24798208
OBJECTIVE	Internet-delivered interventions have proven efficacious in changing people 's behaviours and related determinants , but the actual use of these interventions by the target group is often very low .
OBJECTIVE	This article investigates whether arousing interest and enjoyment results in increased intervention use in an online context .
METHODS	Invitations to visit a website about Hepatitis A , B and C virus infections ( Studies 1 and 3 ) and the website itself ( Studies 2 and 3 ) were manipulated to arouse interest and enjoyment .
METHODS	Intention to visit the website ( Study 1 ) , clicking on the link to visit the website ( Studies 2 and 3 ) and the number of pages visited on the website ( Study 3 ) .
RESULTS	Arousing interest through an invitation resulted in a higher intention to visit the website ( Study 1 ) and a higher likelihood of clicking on the link to visit the website in comparison with arousing enjoyment ( Study 2 ) .
RESULTS	The number of pages visited increased when interest was aroused on the website itself ( Study 3 ) .
CONCLUSIONS	Arousing interest is a promising strategy to increase use of Internet-delivered interventions and potentially increase the public health impact of these interventions .

###24350408
BACKGROUND	Pharmacokinetic changes have been found in critically ill patients , including ventilator-associated pneumonia ( VAP ) when compared with healthy volunteers leading to fluctuation of plasma concentrations .
OBJECTIVE	To compare the probability of target attainment ( PTA ) and cumulative fraction of response ( CFR ) for meropenem between administration by a bolus injection and a 3-hour infusion .
METHODS	The study was a randomized three-way crossover in nine patients with VAP .
METHODS	Each patient received meropenem in three regimens consecutively : ( i ) a bolus injection of 1 g every eight hours ( q8h ) for 24 hours ; ( ii ) a 3-hour infusion of 1 g q8h for 24 hours ; and ( iii ) a 3-hour infusion of 2 g q8h for 24 hours .
METHODS	The pharmacodynamic analysis of meropenem was performed to determine the PTA by using the Monte Carlo simulation and the study used susceptibility patterns obtained from EUCAST and MYSTIC for assessment of CFR .
RESULTS	For an MIC of 4 microg/ml , the PTAs achieving 40 % T > MIC following a bolus injection of 1 g q8h , a 3-hour infusion of 1 g q8h , and a 3-hour infusion of 2 g q8h were 87.71 % , 98.80 % , and 99.90 % , respectively .
RESULTS	Only the 3-hour infusion regimens were predicted to achieve a CFR > or = 90 % against E. coli , Klebsiella spp. , P. aeruginosa , and Acinetobacter spp .
CONCLUSIONS	A 3-hour infusion of 2 g of meropenem regimen was predicted to have the highest PTA rates .
CONCLUSIONS	Only the prolonged infusion regimens achieved a high CFR against E. coli , Klebsiella spp. , P. aeruginosa , and Acinetobacter spp .

###25417170
OBJECTIVE	Eccentric training has been popularized for physical conditioning and prevention/rehabilitation of musculoskeletal disorders , especially due to the expressive responses in terms of muscular strength gain .
OBJECTIVE	In view of evidence that low-level laser therapy ( LLLT ) is able to increase exercise performance and accelerate post-exercise recovery , the aim of this study was to verify the effect of LLLT on hypertrophy and strengthening of knee extensor muscles submitted to eccentric training .
METHODS	Thirty healthy male subjects were randomized into three groups : Control Group ( CG ) , Training Group ( TG ) and Training + LLLT Group ( TLG ) .
METHODS	CG received no intervention , while TG and TLG were engaged on an 8-week knee extensor isokinetic eccentric training program .
METHODS	Only subjects from TLG were treated with LLLT ( wavelength = 810 nm ; power output = 200 mW ; total dosage = 240 J ) before each training session .
METHODS	Knee extensor muscle thickness and peak torque were assessed through ultrasonography and isokinetic dynamometry , respectively .
RESULTS	CG presented no changes in any variable throughout the study , while eccentric training led to significant increases in muscle thickness and peak torque in TG and TLG .
RESULTS	Subjects from TLG reached significantly higher percent changes compared to subjects from TG for sum of muscles ' thicknesses ( 15.4 vs. 9.4 % ) , isometric peak torque ( 20.5 vs. 13.7 % ) , and eccentric peak torque ( 32.2 vs. 20.0 % ) .
CONCLUSIONS	LLLT applied before eccentric training sessions seems to improve the hypertrophic response and muscular strength gain in healthy subjects .

###25013367
BACKGROUND	The Chuanhu anti-gout mixture has been used for many years in the treatment of gout in Chinese Traditional Medicine , and current methods for treatments for acute gouty arthritis have been either less effective or have had serious side effects .
METHODS	In this 12-week , double-blind , double-dummy , non-inferiority study , outpatient individuals with newly diagnosed acute gouty arthritis were randomly assigned to receive Chuanhu anti-gout mixture or colchicine .
METHODS	Both the study investigators and the participants were masked to the treatment assignments .
METHODS	The primary outcome was the recurrence rate of acute gouty arthritis , and the secondary outcomes were changes in white blood cells ( WHC ) and C-reactive protein ( CRP ) .
METHODS	This trial is registered at ISRCTN.org as trial ISRCTN65219941 .
RESULTS	A total of 176 patients were randomly assigned to receive either the Chuanhu anti-gout mixture or Colchicine .
RESULTS	The overall recurrence rates in the Chuanhu anti-gout mixture group ( CH group ) and the Colchicine group ( Col group ) were 12.50 % vs 14.77 % ( difference -2.22 % , 95 % confidence interval ( 95 % CI ) : -10.78 % ~ 6.23 % ) , meeting the predefined non-inferiority criterion of 15 % , as did the data for WHC and CRP .
RESULTS	The incidence of adverse events ( mainly diarrhea ) was less in the Col group than in the CH group ( 2.27 % vs 28.41 % , 95 % CI 0.01 ~ 0.26 ) .
RESULTS	In addition , changes in blood uric acid , alanine aminotransferase , aspartate aminotransferase and creatinine in the CH group were significantly larger compared to those in the Col group ( P < 0.05 ) .
CONCLUSIONS	The Chuanhu anti-gout mixture was non-inferior to colchicine for the treatment of acute gouty arthritis .
CONCLUSIONS	The study suggested that the Chuanhu anti-gout mixture can be considered an alternative choice for the treatment of acute gouty arthritis because of its lower incidence of adverse events and its protection of kidney and renal function .

###25819854
BACKGROUND	Atherosclerotic peripheral artery disease ( PAD ) is common and results in limitations in quality of life and potential progression to limb loss .
BACKGROUND	Options for therapy include medical therapy , supervised exercise , surgical revascularization , and , more recently , endovascular therapies to restore arterial perfusion to the limb .
BACKGROUND	Endovascular revascularization has evolved over the past 2 decades , from percutaneous transluminal angioplasty ( PTA ) to self-expanding stents , atherectomy , laser angioplasty , and drug-eluting stents .
BACKGROUND	Despite impressive technologic advances , PTA remains the standard of care at many institutions and is the recommended primary treatment modality for femoral-popliteal PAD according to current American College of Cardiology Foundation/American Heart Association guidelines .
BACKGROUND	However , restenosis after PTA is common .
BACKGROUND	Therefore , a significant clinical need remains for a device that is able to achieve more durable patency than PTA but does not require a permanent implant .
BACKGROUND	Drug-coated balloons ( DCBs ) have the potential to address this need .
BACKGROUND	Several randomized controlled clinical trials of PTA balloons coated with different formulations of paclitaxel have been conducted in Europe ( N Engl J Med 2008 ; 358:689 -699 ) ( Circulation 2008 ; 118:1358 -1365 ) ( Circ Cardiovasc Interv 2012 ; 5:831 -840 ) ( JACC Cardiovas Interv 2014 ; 7:10 -19 ) and demonstrated more durable efficacy than PTA with comparable safety .
BACKGROUND	These studies were limited by small sample sizes and powered solely for an angiographic primary end point .
BACKGROUND	The pivotal LEVANT 2 trial was designed in collaboration with the US Food and Drug Administration to demonstrate safety and efficacy in a large population and to obtain US Food and Drug Administration approval .
METHODS	A prospective , multicenter , single-blind trial comparing the Lutonix DCB ( Bard Lutonix ; New Hope , MN ) versus PTA for treatment of femoropopliteal PAD ( LEVANT 2 ) is the first US-based 2:1 randomized controlled trial of 476 patients with femoral-popliteal PAD designed to demonstrate superior efficacy and noninferior safety of a novel paclitaxel DCB compared with PTA .
METHODS	The primary efficacy end point is primary patency at 12 months .
METHODS	The primary safety end point is composite freedom at 12 months from perioperative death , index limb amputation , reintervention , and limb-related mortality .
METHODS	A series of important secondary end points include physical functioning , quality of life , revascularizations , and alternative measures of patency .
METHODS	To minimize bias potential for confounding variables , LEVANT 2 ( 1 ) excluded patients stented after predilation before randomization , ( 2 ) incorporated very stringent criteria for bailout stenting , ( 3 ) did not count bailout stenting as a target lesion revascularization or failure of any end point , ( 4 ) required a blinded clinician to perform clinical evaluations at follow-up , and ( 5 ) required clinical assessment before review of duplex ultrasound results .
CONCLUSIONS	LEVANT 2 represents the first US-inclusive multicenter , randomized controlled trial to assess the safety and efficacy of a novel DCB compared with PTA as primary therapy for symptomatic PAD on the background of standard medical therapy .

###24782624
OBJECTIVE	To evaluate the efficacy of endoscopy with a transparent cap on biopsy positioning in Barrett 's esophagus ( BE ) .
METHODS	One hundred and sixty-eight patients with suspected BE at endoscopy were enrolled in our study from November 2007 to December 2009 and divided into two groups : transparent cap group ( n = 60 ) and control group ( n = 108 ) .
METHODS	Endoscopy with or without a transparent cap and subsequent biopsy of suspected lesions were performed by five experienced endoscopists in our hospital .
METHODS	In both groups , two biopsy specimens were taken from each patient , and the columnar epithelium or goblet cells in histological assessment were used as the diagnostic standard for BE .
RESULTS	In the transparent cap group , 41 cases were tongue type , while 17 and two cases were identified as island type and circumferential type , respectively .
RESULTS	In the control group , 65 tongue-type cases were confirmed , with 38 island-type and five circumferential-type cases .
RESULTS	Moreover , there was no significant difference with regard to the composition of endoscopic BE types in the two groups ( P > 0.05 ) .
RESULTS	In the biopsy specimens , BE was detected in 50 cases in the transparent cap group ( 83.3 % , 50/60 ) , whereas the detection rate in the control group ( 69.4 % , 75/108 ) was lower compared to that in the transparent cap group ( P < 0.05 ) .
RESULTS	In addition , goblet cells were recognized in only eight cases ( all with columnar epithelium ) ( 8/60 , 13.3 % ) in the transparent cap group , with 11 cases in the control group .
CONCLUSIONS	Transparent cap-fitted endoscopy can guide biopsy positioning in BE without other accompanying complications , thus increasing the detection rate of BE .

###24499750
OBJECTIVE	To determine the efficacy and safety of a single-incision mini-sling compared with a transobturator midurethral sling for stress urinary incontinence ( SUI ) treatment .
METHODS	This prospective single-center randomized controlled trial involved 130 women with a diagnosis of SUI .
METHODS	Primary outcomes were the objective and subjective cure rates , defined as negative cough stress and pad tests , and satisfaction rates .
METHODS	Quality of life assessed by the Incontinence Quality of Life Questionnaire and the Urogenital Distress Inventory Short Form , operation time , complications , and reoperation rates were also recorded .
METHODS	The efficacy was analyzed using a noninferiority test with a margin of 15 % .
METHODS	For the noninferiority test , a P value > .05 rejects the noninferiority hypothesis of the mini-sling .
RESULTS	Sixty-four patients in the mini-sling group and 56 in the transobturator group completed the 12-month follow-up .
RESULTS	The objective cure rates for the mini-sling and the transobturator sling were 68.1 % and 81.9 % ( absolute difference 13.8 ; 90 % confidence interval [ CI ] 1.5-26 .1 ; P = .439 ) and the subjective cure rates were 81.1 % and 88.5 % ( absolute difference 7.4 % ; 90 % CI 2.8-17 .6 ; P = .110 ) , respectively .
RESULTS	There was a significant improvement in quality of life in both groups .
RESULTS	Thigh pain was greater after the transobturator sling , four patients ( 7.1 % ) compared with zero ( P = .045 ) .
RESULTS	The mean operation time was 5 minutes shorter for the mini-sling procedure ( P = .000 ) .
RESULTS	Five patients ( 7.8 % ) in the mini-sling group and one patient ( 1.8 % ) in the transobturator group underwent surgical reintervention for persistent SUI ( P = .213 ) .
CONCLUSIONS	The noninferiority of the mini-sling could not be demonstrated in this study at the 12-month follow-up .
CONCLUSIONS	The mini-sling was associated with shorter operative time and less postoperative thigh pain .
BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT01094353 .

###24262967
BACKGROUND	Various cytochrome P450 isoforms modulate sibutramine activity and influence sibutramine plasma levels and pharmacokinetics .
BACKGROUND	However , there are no available data to demonstrate the association of these polymorphisms with the clinical outcomes of sibutramine administration .
METHODS	This study was a sub-investigation of a 12-week , double-blind , placebo-controlled trial examining the additive effect of orlistat on sibutramine .
METHODS	The final analysis was restricted to 101 women who had fulfilled the protocol .
METHODS	We evaluated the effects of genetic polymorphisms of CYP3A5 , CYP2C19 and CYP2B6 on the % weight loss and the occurrence of adverse events .
RESULTS	The change of pulse rate from baseline value was affected by both CYP2B6 and CYP3A5 genetic polymorphisms ( P < .01 for CYP3A5 and P = .01 for CYP2B6 ) .
RESULTS	Both CYP2B6 and CYP3A5 showed gene-gene interactions ( P < .01 ) .
RESULTS	After adjusting for significant variables in the backward stepwise regression model , the change of pulse rate and time-dependent weight reduction were significant only among the CYP2B6 genotypes ( P = .027 and P < .01 , respectively ) .
CONCLUSIONS	The CYP2B6 * 6 allele influences the extent of weight reduction and pulse rate changes in patients undergoing sibutramine treatment .

###24291168
BACKGROUND	Enterotoxigenic Escherichia coli ( ETEC ) is a major cause of travellers ' diarrhoea .
BACKGROUND	We investigated the efficacy and safety of a skin-patch vaccine containing the pathogen 's heat-labile toxin ( LT ) in a population of travellers to Mexico and Guatemala .
METHODS	In this phase 3 , randomised , double-blind , placebo-controlled field trial , healthy adults ( aged 18-64 years ) travelling from Germany or the UK to Mexico or Guatemala were assigned in a 1:1 ratio by a dynamic electronic randomisation system to receive transcutaneous immunisation with a patch containing 37.5 g of ETEC LT or a placebo patch .
METHODS	Participants , site staff , and the investigators who did the analyses were masked to group assignment .
METHODS	Participants were vaccinated before travel , with two patches given 14 days apart .
METHODS	In the destination country , participants tracked stool output in a diary and provided stool samples for pathogen identification if diarrhoea occurred .
METHODS	The primary endpoint was the proportion of participants with at least one episode of moderate-to-severe diarrhoea ( defined as four or more unformed stools in a 24 h period ) in which either or both ETEC enterotoxins ( LT and heat-stable toxin [ ST ] ) were detected .
METHODS	The study is registered at ClinicalTrials.gov , number NCT00993681 .
RESULTS	2036 participants were recruited and randomly assigned between Oct 14 , 2009 , and Aug 13 , 2010 , with 1016 allocated to receive the LT patch and 1020 the placebo patch .
RESULTS	821 participants in the LT-patch group and 823 in the placebo group received both vaccinations and were analysed in the per-protocol population .
RESULTS	30 ( 3.7 % , 95 % CI 2.5-5 .2 ) participants in the LT-patch group and 46 ( 5.6 % , 4.1-7 .4 ) in the placebo group had moderate or severe ETEC diarrhoea ( vaccine efficacy 34.6 % , -2.2 to 58.9 ; p = 0.0621 ) .
RESULTS	9333 local ( ie , patch-site ) adverse events ( including erythema , rash , pruritus , hyperpigmentation , pain , hypopigmentation , and oedema ) occurred in 943 ( 93 % ) of 1015 participants in the LT-patch group , compared with 1444 local adverse events in 574 ( 56 % ) of 1019 participants in the placebo group ( p < 0.0001 ) .
RESULTS	Serious adverse events occurred in 25 participants ( 14 in the LT-patch group and 11 in the placebo group ) , with all regarded as either unrelated or possibly related to treatment .
RESULTS	Vaccine-induced hyperpigmentation persisted for at least 180 days after vaccination in 150 ( 18 % ) of the 849 participants who received both vaccinations and returned for final assessment in the LT-patch group , compared with none of the 842 participants in the placebo group .
RESULTS	The vaccine was immunogenic , with a post-vaccination geometric mean titre of LT-specific serum immunoglobulin G of 3400.29 , compared with 315.41 in the placebo group .
CONCLUSIONS	Although the LT antigen was delivered effectively by the skin patch , the vaccine did not protect travellers against diarrhoea caused by ETEC or other organisms .
CONCLUSIONS	Future vaccines against travellers ' diarrhoea might need to include several antigens against various diarrhoeal pathogens , and might need to be able to generate mucosal and higher systemic immunity .

###25430452
BACKGROUND	There are several methods for postoperative analgesia for knee surgery .
BACKGROUND	The commonly utilized method is multimodal analgesia based on continuous femoral nerve block .
BACKGROUND	The aim of this study was to investigate the application of continuous adductor canal block for analgesia after total knee replacement and compare this method with continuous femoral nerve block .
METHODS	Sixty patients scheduled for total knee replacement from June 2013 to March 2014 were randomly divided into a femoral group and an adductor group .
METHODS	Catheters were placed under the guidance of nerve stimulation in the femoral group and under the guidance of ultrasound in the adductor group .
METHODS	Operations were performed under combined spinal and epidural anesthesia .
METHODS	After the operations , 0.2 % ropivacaine was given at a speed of 5 ml/h through catheters in all patients .
METHODS	Visual analogue scale ( VAS ) pain scores at rest and while moving were noted at 4 , 24 , and 48 hours after the operation , and quadriceps strength was also assessed at these time-points .
METHODS	Secondary parameters such as doses of complementary analgesics and side effects were also recorded .
RESULTS	There were no significant differences between the groups in VAS pain scores at rest or while moving , at 4 , 24 , or 48 hours after the operation ( P > 0.05 ) .
RESULTS	At these time-points , mean quadriceps strengths in the adductor group were 3.0 ( 2.75-3 .0 ) , 3.0 ( 3.0-4 .0 ) , and 4.0 ( 3.0-4 .0 ) , respectively , all of which were significantly stronger than the corresponding means in the femoral group , which were 2.0 ( 2.0-3 .0 ) , 2.0 ( 2.0-3 .0 ) , and 3.0 ( 2.0-4 .0 ) , respectively ( P < 0.05 ) .
RESULTS	There were no significant differences between the groups in doses of complementary analgesics or side effects ( P > 0.05 ) .
RESULTS	X-ray images of some patients showed that local anesthetic administered into the adductor canal could diffuse upward and reach the femoral triangle .
CONCLUSIONS	Continuous adductor canal block with 0.2 % ropivacaine could be used effectively for analgesia after total knee replacement .
CONCLUSIONS	Compared with continuous femoral nerve block , this analgesic method has similar analgesic effects and is associated with less weakness of quadriceps muscle .

###24372760
BACKGROUND	Comparative effectiveness research ( CER ) has become a major focus of cardiovascular disease investigation to optimize diagnosis and treatment paradigms and decrease healthcare expenditures .
BACKGROUND	Acute chest pain is a highly prevalent reason for evaluation in the Emergency Department ( ED ) that results in hospital admission for many patients and excess expense .
BACKGROUND	Improvement in noninvasive diagnostic algorithms can potentially reduce unnecessary admissions .
OBJECTIVE	To compare the performance of treadmill stress echocardiography ( SE ) and coronary computed tomography angiography ( CTA ) in ED chest pain patients with low-to-intermediate risk of significant coronary artery disease .
METHODS	This is a single-center , randomized controlled trial ( RCT ) comparing SE and CTA head-to-head as the initial noninvasive imaging modality .
METHODS	The primary outcome measured is the incidence of hospitalization .
METHODS	The study is powered to detect a reduction in admissions from 28 % to 15 % with a sample size of 400 .
METHODS	Secondary outcomes include length of stay in the ED/hospital and estimated cost of care .
METHODS	Safety outcomes include subsequent visits to the ED and hospitalizations , as well as major adverse cardiovascular events at 30days and 1year .
METHODS	Patients who do not meet study criteria or do not consent for randomization are offered entry into an observational registry .
CONCLUSIONS	This RCT will add to our understanding of the roles of different imaging modalities in triaging patients with suspected angina .
CONCLUSIONS	It will increase the CER evidence base comparing SE and CTA and provide insight into potential benefits and limitations of appropriate use of treadmill SE in the ED .

###25491433
BACKGROUND	Overactive bladder ( OAB ) is highly prevalent and is associated with considerable morbidity and reduced health-related quality of life .
BACKGROUND	3-adrenergic receptor ( 3-AR ) stimulation is a novel alternative to antimuscarinic therapy for OAB .
OBJECTIVE	The objective of this analysis was to assess the cost effectiveness of the 3-AR agonist mirabegron relative to tolterodine extended release ( ER ) in patients with OAB from a UK National Health Service ( NHS ) perspective .
METHODS	A Markov model was developed to simulate the management , course of disease , and effect of complications in OAB patients over a period of 5years .
METHODS	Transition probabilities for symptom severity levels and probabilities of adverse events were estimated from the results of the randomised , double-blind SCORPIO trial in 1,987 patients with OAB .
METHODS	Other model inputs were derived from the literature and on assumptions based on clinical experience .
RESULTS	Total 5-year costs per patient were 1,645.62 for mirabegron 50mg/day and 1,607.75 for tolterodine ER 4mg/day .
RESULTS	Mirabegron was associated with a gain of 0.009 quality-adjusted life-years ( QALYs ) with an additional cost of 37.88 .
RESULTS	The resulting incremental cost-effectiveness ratio ( ICER ) was 4,386 / QALY gained .
RESULTS	In deterministic sensitivity analyses in the general OAB population and several subgroups , ICERs remained below the generally accepted willingness-to-pay ( WTP ) threshold of 20,000 / QALY gained .
RESULTS	The probability of mirabegron 50mg being cost effective relative to tolterodine ER 4mg was 89.4 % at the same WTP threshold .
CONCLUSIONS	Mirabegron 50mg/day is likely to be cost effective compared with tolterodine ER 4mg/day for adult patients with OAB from a UK NHS perspective .

###24948048
OBJECTIVE	To compare the efficacy of mifepristone and ethacridine lactate with ethacridine lactate alone for second trimester pregnancy termination .
METHODS	Two hundred and seventy-six healthy women between 16 and 27 weeks of gestation , desiring a termination , were assigned at random into two groups .
METHODS	The study group consisted of 140 women who received an intra-amniotic injection of 100mg ethacridine lactate , followed by oral administration of 50mg mifepristone at 0 , 12 and 24h ( total dose of mifepristone 150mg ) .
METHODS	The control group consisted of 136 women who received an intra-amniotic injection of 100mg ethacridine lactate alone .
METHODS	The primary outcome measure was the induction-to-abortion interval .
METHODS	Secondary outcomes included blood loss in 24h , successful abortion rate , retained placental tissue rate , rate of uterine evacuation and cervical laceration .
RESULTS	Induction-to-abortion interval , blood loss in 24h , rate of retained placental tissue and uterine evacuation were significantly less in the study group compared with the control group ( p < 0.001 ) .
RESULTS	Termination was successful in 140 of 140 women ( 100 % ) in the study group and 133 of 136 women ( 97.8 % ) in the control group .
RESULTS	All women in the study group delivered within 72h , and three nulliparous women in the control group did not deliver within 72h .
RESULTS	The cervical laceration rate was 0 and 1.47 % ( 2/136 ) in the study group and the control group , respectively .
RESULTS	No significant difference in the successful abortion rate ( p = 0.235 ) or the cervical laceration rate ( p = 0.242 ) was found between the two groups .
CONCLUSIONS	Mifepristone in combination with ethacridine lactate may significantly improve the outcomes of second trimester pregnancy termination compared with ethacridine lactate alone , without increasing complications and side effects apart from nausea .

###24482383
OBJECTIVE	Ticagrelor reduces thrombotic events compared with clopidogrel in patients with acute coronary syndrome , but may also increase bleeding complications .
OBJECTIVE	Coronary artery bypass grafting ( CABG ) - related bleeding complications have not previously been compared in clopidogrel and ticagrelor-treated patients outside the controlled environment of clinical trials .
METHODS	Four hundred and five consecutive CABG patients with acute coronary syndrome were included in a prospective observational study .
METHODS	The patients were treated with aspirin and ticagrelor ( n = 173 ) or aspirin and clopidogrel ( n = 232 ) .
METHODS	Ticagrelor/clopidogrel was discontinued 5 days before surgery whenever deemed possible .
METHODS	Major bleeding complications according to modified blood conservation using antifibrinolytics in a randomized trial criteria ( postoperative blood loss > 1500 ml/12 h , re-exploration , red blood cell transfusion > 10 units or death because of bleeding ) were compared in all patients and when ticagrelor/clopidogrel was discontinued 5 days ( n = 280 ) , 2-4 days ( n = 40 ) or 0-1 day before surgery ( n = 85 ) .
RESULTS	Major bleeding complications did not differ significantly between ticagrelor - and clopidogrel-treated patients when all patients were compared ( 14.5 vs 13.8 % , P = 0.89 ) .
RESULTS	Likewise , there were no significant differences between ticagrelor and clopidogrel when either drug was discontinued 5 days before surgery ( 6.8 vs 9.9 % , P = 0.40 ) or 2-4 days before surgery ( 6.3 vs 25.0 % , P = 0.21 ) .
RESULTS	When ticagrelor/clopidogrel was discontinued 0-1 day before surgery , there was a strong trend towards higher incidence of major bleeding in ticagrelor-treated patients ( 41.0 vs 21.7 % , P = 0.063 ) .
CONCLUSIONS	There was no difference in major bleeding complications overall or when ticagrelor or clopidogrel was used in accordance with guidelines .
CONCLUSIONS	In patients on dual antiplatelet medication up to 1 day before surgery , there tended to be more bleeding complications in ticagrelor-treated patients .

###25343570
OBJECTIVE	Ventilator-associated pneumonia diagnosis remains a debatable topic .
OBJECTIVE	New definitions of ventilator-associated conditions involving worsening oxygenation have been recently proposed to make surveillance of events possibly linked to ventilator-associated pneumonia as objective as possible .
OBJECTIVE	The objective of the study was to confirm the effect of subglottic secretion suctioning on ventilator-associated pneumonia prevalence and to assess its concomitant impact on ventilator-associated conditions and antibiotic use .
METHODS	Randomized controlled clinical trial conducted in five ICUs of the same hospital .
METHODS	Three hundred fifty-two adult patients intubated with a tracheal tube allowing subglottic secretion suctioning were randomly assigned to undergo suctioning ( n = 170 , group 1 ) or not ( n = 182 , group 2 ) .
RESULTS	During ventilation , microbiologically confirmed ventilator-associated pneumonia occurred in 15 patients ( 8.8 % ) of group 1 and 32 patients ( 17.6 % ) of group 2 ( p = 0.018 ) .
RESULTS	In terms of ventilatory days , ventilator-associated pneumonia rates were 9.6 of 1,000 ventilatory days and 19.8 of 1,000 ventilatory days , respectively ( p = 0.0076 ) .
RESULTS	Ventilator-associated condition prevalence was 21.8 % in group 1 and 22.5 % in group 2 ( p = 0.84 ) .
RESULTS	Among the 47 patients with ventilator-associated pneumonia , 25 ( 58.2 % ) experienced a ventilator-associated condition .
RESULTS	Neither length of ICU stay nor mortality differed between groups ; only ventilator-associated condition was associated with increased mortality .
RESULTS	The total number of antibiotic days was 1,696 in group 1 , representing 61.6 % of the 2,754 ICU days , and 1,965 in group 2 , representing 68.5 % of the 2,868 ICU days ( p < 0.0001 ) .
CONCLUSIONS	Subglottic secretion suctioning resulted in a significant reduction of ventilator-associated pneumonia prevalence associated with a significant decrease in antibiotic use .
CONCLUSIONS	By contrast , ventilator-associated condition occurrence did not differ between groups and appeared more related to other medical features than ventilator-associated pneumonia .

###25253184
OBJECTIVE	Recurrent respiratory infections ( RRI ) constitute a social problem for both the pharmaco-economic impact and the burden for the family .
OBJECTIVE	Pidotimod is a synthetic immunostimulant .
OBJECTIVE	The aim of this study was to evaluate the effects of pidotimod on RRI prevention in children .
METHODS	Globally , 100 children ( 49 males , mean age 4.7 1.2 years ) with RRI were enrolled in the study .
METHODS	At baseline , children were randomly assigned to the treatment with pidotimod 400 mg/die or not for two months .
METHODS	Children were visited at baseline , after 30 ( T1 ) and 60 ( T2 ) days , and at follow-up ( 120 days ; T3 ) .
METHODS	Number of children with upper and lower airways symptoms , medications use , school attendance , and paediatric visits for RRI were evaluated .
RESULTS	Pidotimod treatment was able of significantly reducing the number of children with upper and lower airways symptoms , and medications use , increasing school attendance , and reducing pediatric visits for RRI .
CONCLUSIONS	This study provided the evidence that pidotimod may be able of preventing RRI in children .

###24512654
OBJECTIVE	Under Food and Drug Administration investigational device exemption , the Prospective Randomized On-X Anticoagulation Clinical Trial ( PROACT ) has been testing the safety of less aggressive anticoagulation than recommended by the American College of Cardiology/American Heart Association guidelines after implantation of an approved bileaflet mechanical valve .
METHODS	In this first limb of the PROACT , patients with elevated risk factors for thromboembolism were randomized at 33 US centers to receive lower dose warfarin ( test international normalized ratio [ INR ] , 1.5-2 .0 ) or continue standard warfarin ( control INR , 2.0-3 .0 ) , 3 months after mechanical aortic valve replacement .
METHODS	The INR was adjusted by home monitoring ; all patients received 81 mg aspirin daily .
METHODS	Adverse events were independently adjudicated .
RESULTS	A total of 375 aortic valve replacement patients were randomized into control ( n = 190 ) and test ( n = 185 ) groups from September 2006 to December 2009 .
RESULTS	The mean age standard deviation was 55.2 12.5 years ; 79 % were men ; and 93 % were in sinus rhythm preoperatively .
RESULTS	Calcific degeneration was present in 67 % ; active endocarditis was excluded .
RESULTS	Concomitant procedures included coronary artery bypass grafting ( 27 % ) , aortic aneurysm repair ( 14 % ) , and other ( 25 % ) .
RESULTS	The follow-up duration averaged 3.82 years ( 755.7 patient-years [ pt-yrs ] for control ; 675.2 pt-yrs for test ) .
RESULTS	The mean INR was 2.50 0.63 for the control and 1.89 0.49 for the test groups ( P < .0001 ) .
RESULTS	The test group experienced significantly lower major ( 1.48 % vs 3.26 % / pt-yr ; P = .047 ) and minor ( 1.32 % vs 3.41 % / pt-yr ; P = .021 ) bleeding rates .
RESULTS	The incidence of stroke , transient ischemic attack , total neurologic events , and all-cause mortality were similar between the 2 groups .
CONCLUSIONS	INR can be safely maintained between 1.5 and 2.0 after aortic valve replacement with this approved bileaflet mechanical prosthesis .
CONCLUSIONS	With low-dose aspirin , this resulted in a significantly lower risk of bleeding , without a significant increase in thromboembolism .

###24833067
BACKGROUND	Addressing the two most important considerations in designing clinical trials , i.e. maximizing study power and minimizing patient exposure to ineffective treatment , is particularly challenging for trials of rare diseases .
BACKGROUND	The familial Mediterranean fever ( FMF ) rilonacept trial ( Hashkes et al. , Ann Intern Med 2012 ; 157:533 -41 ) demonstrates a novel crossover design by enabling patient choice to early escape for rare disease .
OBJECTIVE	To investigate the effect on study power , exposure to the ineffective treatment arm and dropout rate by implementing early escape to crossover design , and to propose a Bayesian modeling approach .
METHODS	Based on the FMF trial data , simulation studies compared study power and dropout rate among three types of designs for crossover trial : traditional without early escape , early escape per-patient-choice , and early escape per-protocol .
RESULTS	The early escape per patient choice or per protocol design achieved 0.89 0.12 and 0.78 0.20 of the study efficiency when compared to the traditional crossover design assuming no dropout .
RESULTS	Early escape per patient choice compared to early escape per protocol improved power by 1.29 0.26 , and reduced the dropout rate by 8-29 % , but with greater patient exposure to the less effective treatment arm .
CONCLUSIONS	The results of the FMF trial and simulation studies suggest that allowing early escape in crossover trial enhanced the design by minimizing patient 's exposure to the ineffective treatment arm while maintaining a reasonable study power , which is particularly important for rare disease trials .
CONCLUSIONS	Choice between the two types of early escape presents tradeoff between study power and exposure to ineffective treatment .

###25678546
BACKGROUND	Epidemiological studies suggest that exercise has a tremendous preventative effect on morbidity and premature death , but these findings need to be confirmed by randomised trials .
BACKGROUND	Generation 100 is a randomised , controlled study where the primary aim is to evaluate the effects of 5years of exercise training on mortality in an elderly population .
METHODS	All men and women born in the years 1936-1942 ( n = 6966 ) , who were residents of Trondheim , Norway , were invited to participate .
METHODS	Between August 2012 and June 2013 , a total of 1567 individuals ( 790 women ) were included and randomised to either 5years of two weekly sessions of high-intensity training ( 10min warm-up followed by 44min intervals at 90 % of peak heart rate ) or , moderate-intensity training ( 50min of continuous work at 70 % of peak heart rate ) , or to a control group that followed physical activity advice according to national recommendations .
METHODS	Clinical examinations , physical tests and questionnaires will be administered to all participants at baseline , and after 1 , 3 and 5years .
METHODS	Participants will also be followed up by linking to health registries until year 2035 .
BACKGROUND	The study has been conducted according to the SPIRIT statement .
BACKGROUND	All participants signed a written consent form , and the study has been approved by the Regional Committee for Medical Research Ethics , Norway .
BACKGROUND	Projects such as this are warranted in the literature , and we expect that data from this study will result in numerous papers published in world-leading clinical journals ; we will also present the results at international and national conferences .
BACKGROUND	Clinical trial gov NCT01666340 .

###24238792
BACKGROUND	Opioid-induced constipation ( OIC ) is a common adverse effect associated with opioid use .
BACKGROUND	Naloxegol is a PEGylated derivative of naloxone in clinical development as a once-daily oral treatment of OIC .
OBJECTIVE	A thorough QT/QTc study was conducted , according to International Conference on Harmonisation E14 guidelines , to characterize the effect of naloxegol on cardiac repolarization .
METHODS	In this randomized , positive - and placebo-controlled crossover study , healthy men received a single dose of naloxegol 25 mg ( therapeutic dose ) , naloxegol 150 mg ( supratherapeutic dose ) , moxifloxacin 400 mg ( positive control ) , or placebo in 1 of 4 sequences ( Williams Latin square design ) .
METHODS	The washout time between treatment periods was at least 5 days .
METHODS	Digital 12-lead ECGs were recorded at baseline and at 10 time points over 24 hours after dosing in each treatment period .
METHODS	QT intervals were corrected for heart rate using the Fridericia formula ( QTcF ) and the Bazett formula ( QTcB ) .
RESULTS	A total of 52 subjects were enrolled ( mean age , 28 years ) , and 45 received all 4 treatments .
RESULTS	The placebo-corrected , baseline-adjusted , mean increases in QTcF with naloxegol 25 and 150 mg were both < 5 msec at each time point , and all upper limits of the 2-sided 90 % CI were < 10 msec .
RESULTS	Similar findings were observed using QTcB ; the upper limits of the 2-sided 90 % CI were < 10 msec at all time points after dosing with naloxegol 25 or 150 mg .
RESULTS	With moxifloxacin 400 mg , mean QTcF was increased by a maximum of 11.1 msec ( 90 % CI , 9.3-12 .9 msec ) , supporting assay sensitivity .
CONCLUSIONS	Naloxegol at 25 and 150 mg was not associated with QT/QTc interval prolongation in these healthy men , and at the proposed therapeutic dose of 25 mg/d , naloxegol is not expected to have a clinically relevant effect on cardiac repolarization in patients with OIC .
CONCLUSIONS	ClinicalTrials.gov identifier : NCT01325415 .

###25034347
OBJECTIVE	Assess the effect of counter-advertisements on parents ' appraisals of unhealthy foods featuring front-of-package promotions ( FOPPs ) .
METHODS	A 2 2 5 between-subjects Web-based experiment .
METHODS	Parents were randomly shown an advertisement ( counter-advertisement challenging FOPP/control advertisement ) and then a pair of food products from the same category : an unhealthy product featuring an FOPP ( nutrient content claim/sports celebrity endorsement ) and a healthier control product with no FOPP .
METHODS	Australia .
METHODS	A total of 1,269 Australian-based parents of children aged 5-12 years recruited from an online panel .
METHODS	Parents nominated which product they would prefer to buy and which they thought was healthier , then rated the unhealthy product and FOPP on various characteristics .
METHODS	Differences between advertisement conditions were assessed using logistic regression ( product choice tasks ) and analysis of variance tests ( ratings of unhealthy product and FOPP ) .
RESULTS	Compared with parents who saw a control advertisement , parents who saw a counter-advertisement perceived unhealthy products featuring FOPPs as less healthy , expressed weaker intentions for buying such products , and were more likely to read the nutrition facts panel before nominating choices ( all P < .001 ) .
CONCLUSIONS	Counter-advertising may help reduce the misleading influence of unhealthy food marketing and improve the accuracy of parents ' evaluations of how nutritious promoted food products are .

###24400077
OBJECTIVE	Glucagon-like peptide-1 ( GLP-1 ) may provide beneficial cardiovascular effects , possibly due to enhanced myocardial energetic efficiency by increasing myocardial glucose uptake ( MGU ) .
OBJECTIVE	We assessed the effects of GLP-1 on MGU in healthy subjects during normo - and hypoglycemia .
METHODS	We included eighteen healthy men in two randomized , double-blinded , placebo-controlled cross-over studies .
METHODS	MGU was assessed with GLP-1 or saline infusion during pituitary-pancreatic normo - ( plasma glucose ( PG ) : 4.5 mM , n = 10 ) and hypoglycemic clamps ( PG : 3.0 mM , n = 8 ) by positron emission tomography with ( 18 ) fluoro-deoxy-glucose ( ( 18 ) F-FDG ) as tracer .
RESULTS	In the normoglycemia study mean ( SD ) age was 253 years , and BMI was 22.60.6 kg/m ( 2 ) and in the hypoglycemia study the mean age was 232 years with a mean body mass index of 232 kg/m ( 2 ) .
RESULTS	GLP-1 did not change MGU during normoglycemia ( mean ( + / - SD ) 0.15 + / -0.04 and 0.16 + / -0.03 mol/g/min , P = 0.46 ) or during hypoglycemia ( 0.16 + / -0.03 and 0.13 + / -0.04 mol/g/min , P = 0.14 ) .
RESULTS	However , the effect of GLP-1 on MGU was negatively correlated to baseline MGU both during normo - and hypoglycemia , ( P = 0.006 , r ( 2 ) = 0.64 and P = 0.018 , r ( 2 ) = 0.64 , respectively ) and changes in MGU correlated positively with the level of insulin resistance ( HOMA 2IR ) during hypoglycemia , P = 0.04 , r ( 2 ) = 0.54 .
RESULTS	GLP-1 mediated an increase in circulating glucagon levels at PG levels below 3.5 mM and increased glucose infusion rates during the hypoglycemia study .
RESULTS	No differences in other circulating hormones or metabolites were found .
CONCLUSIONS	While GLP-1 does not affect overall MGU , GLP-1 induces changes in MGU dependent on baseline MGU such that GLP-1 increases MGU in subjects with low baseline MGU and decreases MGU in subjects with high baseline MGU .
CONCLUSIONS	GLP-1 preserves MGU during hypoglycemia in insulin resistant subjects .
CONCLUSIONS	ClinicalTrials.gov registration numbers : NCT00418288 : ( hypoglycemia ) and NCT00256256 : ( normoglycemia ) .

###24781217
BACKGROUND	The effectiveness of non-invasive positive pressure ventilation ( NIV ) in COPD patients with prolonged hypercapnia after ventilatory support for acute respiratory failure ( ARF ) remains unclear .
BACKGROUND	We investigated if nocturnal NIV in these patients prolongs the time to readmission for respiratory causes or death ( primary endpoint ) in the following 12months .
METHODS	201 COPD patients admitted to hospital with ARF and prolonged hypercapnia > 48h after termination of ventilatory support were randomised to NIV or standard treatment .
METHODS	Secondary outcomes were daytime arterial blood gasses , transcutaneous PCO2 during the night , lung function , health-related quality-of-life ( HRQL ) , mood state , daily activities and dyspnoea .
RESULTS	1year after discharge , 65 % versus 64 % of patients ( NIV vs standard treatment ) were readmitted to hospital for respiratory causes or had died ; time to event was not different ( p = 0.85 ) .
RESULTS	Daytime PaCO2 was significantly improved in NIV versus standard treatment ( PaCO2 0.5 kPa ( 95 % CI 0.04 to 0.90 , p = 0.03 ) ) as was transcutaneous PCO2 during the night .
RESULTS	HRQL showed a trend ( p = 0.054 , Severe Respiratory Insufficiency questionnaire ) in favour of NIV .
RESULTS	Number of exacerbations , lung function , mood state , daily activity levels or dyspnoea was not significantly different .
CONCLUSIONS	We could not demonstrate an improvement in time to readmission or death by adding NIV for 1year in patients with prolonged hypercapnia after an episode of NIV for ARF .
CONCLUSIONS	There is no reason to believe the NIV was not effective since daytime PaCO2 and night-time PCO2 improved .
CONCLUSIONS	The trend for improvement in HRQL favouring NIV we believe nevertheless should be explored further .
BACKGROUND	NTR1100 .

###24683594
OBJECTIVE	This study evaluated the effect of either an intermediate application of adhesive resin or flowable resin application on the adhesion of particulate filler composite ( PFC ) to glass fiber-reinforced composite ( FRC ) .
METHODS	Unidirectional , pre-impregnated S2-glass fiber bundles ( Dentapreg ) ( length : 40 mm ; thickness : 0.5 mm ) were obtained ( N = 30 , n = 10 per group ) and secured in translucent silicone material with the adhesion surface exposed and photopolymerized .
METHODS	They were randomly divided into 3 groups for the following adhesion sequence : A ) FRC+PFC , B ) FRC + intermediate adhesive resin + PFC , C ) FRC + flowable resin + PFC. The PFC was applied in a polyethylene mold onto the FRC and photopolymerized .
METHODS	PFCs were debonded from the FRC surface using shear bond test in a universal testing machine ( 1 mm/min ) .
METHODS	After debonding , all specimens were analyzed using scanning electron microscopy to categorize the failure modes .
METHODS	The data were statistically analyzed using one-way ANOVA and Tukey 's tests ( = 0.05 ) .
RESULTS	A significant difference was observed between the groups ( p < 0.05 ) .
RESULTS	The highest mean bond strength value was obtained with the application of an intermediate layer of adhesive resin ( group B : 19.4 1.1 MPa ) ( p < 0.05 ) followed by group A ( 14.1 0.6 MPa ) and group C ( 10.4 0.8 MPa ) , which were also significantly different from one another ( p < 0.05 ) .
RESULTS	Group A exclusively presented a combination of partial cohesive failure in the PFC and adhesive failure between the FRC and PFC. While group B showed large cohesive defects in the FRC , in group C , only small cohesive failures were observed in the FRC .
CONCLUSIONS	Based on the highest mean bond strength and the large cohesive failures within the FRC , application of an intermediate layer of adhesive resin on the S2-glass FRC surface prior to incremental build up of the PFC seems to be compulsory .

###25009197
BACKGROUND	In vitro and retrospective clinical studies suggest an association between anaesthetic technique during primary breast cancer surgery and cancer outcome .
BACKGROUND	Apoptosis is an important step in the mechanism of breast cancer metastasis , but whether it is influenced by anaesthetic technique is unknown .
BACKGROUND	Using serum from breast cancer surgery patients randomized to receive distinct anaesthetic techniques , we investigated its effect on apoptosis in oestrogen receptor ( ER ) - negative breast cancer cells in vitro .
METHODS	Women with biopsy-proven breast cancer were randomized to receive either propofol general anaesthesia with paravertebral analgesia ( PPA ) or standard sevoflurane general anaesthesia with opioid analgesia ( SGA ) in an ongoing , prospective clinical trial ( NCT 00418457 ) .
METHODS	Serum from a randomly selected subset of these patients ( 10 PPA and 10 SGA ) who had donated 20 ml venous blood immediately before anaesthetic induction and at 1 h after operation was exposed to ER-negative MDA-MB-231 cells .
METHODS	Apoptosis was measured using ApoLive-Glo Multiplex Assay .
RESULTS	Exposure of MDA-MB-231 cells to postoperative serum of PPA patients resulted in higher luminescence ratio ( apoptosis ) than SGA patients , median ( 25-75 % ) , 0.40 ( 0.35-0 .43 ) compared with 0.22 ( 0.21-0 .30 ) , respectively ( P = 0.001 ) .
RESULTS	The luminescence ratio of postoperative serum from SGA was reduced compared with preoperative SGA 0.22 ( 0.21-0 .30 ) compared with 0.3 ( 0.25-0 .35 ) ( P = 0.045 ) .
CONCLUSIONS	Serum from patients given sevoflurane anaesthesia and opioids for primary breast cancer surgery reduces apoptosis in ER-negative breast cancer cells to a greater extent than serum from patients given propofol-paravertebral anaesthesia .
CONCLUSIONS	Anaesthetic technique might affect the serum milieu in a manner that impacts cancer cell apoptosis , and thereby tumour metastasis .

###24837794
BACKGROUND	There is uncertainty regarding the optimal dosing regimen for the resumption of warfarin after interruption for invasive procedures .
OBJECTIVE	To determine the efficacy and safety of warfarin resumption with loading doses or with the most recent maintenance dose .
METHODS	Patients receiving warfarin treatment and planned for invasive procedures with an expected hospital stay of 1 day were randomized to resume warfarin on the day of the procedure , defined as day 1 , with most recent maintenance dose or with 2 initial days of double maintenance dose .
METHODS	Efficacy outcomes were proportion of international normalized ratio ( INR ) levels 2.0 on day 5 ( primary outcome ) and day 10 .
METHODS	Safety outcomes were bleeding and thromboembolic events .
METHODS	In addition , D-dimer levels were analyzed on days 5 and 10 in a subset of the population .
RESULTS	There were 49 patients analyzed in each group .
RESULTS	INR of 2.0 had been achieved by day 5 for 13 % in the maintenance-dose group and for 50 % in the loading-dose group ( relative risk [ RR ] 0.27 , 95 % confidence interval [ CI ] 0.10-0 .60 ) and by day 10 for 68 % and 87 % , respectively ( RR 0.78 , 95 % CI 0.65-1 .00 ) .
RESULTS	There were no thromboembolic events , and there was one major bleed before resumption of warfarin and one minor bleed , both in the maintenance-dose group .
RESULTS	There was no difference between the groups in the proportion of patients with excessive INRs or elevated D-dimer levels or in the median D-dimer level .
CONCLUSIONS	Resumption of warfarin after minor-moderately invasive procedures with two loading doses achieves therapeutic INR faster than does only maintenance dose .

###24559754
OBJECTIVE	To determine if self-reported anxiety levels decreased after tracheostomy placement in a sample of mechanically ventilated intensive care unit patients .
BACKGROUND	There is limited research regarding the impact of a tracheostomy on patients ' anxiety .
BACKGROUND	Elevated anxiety delays healing and contributes to long-term mental health complications .
METHODS	This was a secondary analysis of data from a large clinical trial conducted in urban Minnesota .
METHODS	Fifty-one of 116 patients received a tracheostomy .
METHODS	Anxiety scores were obtained daily using the Visual Analog Scale-Anxiety .
METHODS	Mixed model analysis was used to compare anxiety ratings pre - and post-tracheostomy .
RESULTS	There was no significant decrease in anxiety following tracheostomy after controlling for time and gender ( all p > .16 ) .
RESULTS	Age was the only variable to impact anxiety levels : anxiety scores increased as age increased ( p = .02 ) .
CONCLUSIONS	Prospective studies are needed to more accurately assess the impact of tracheostomy placement on patient anxiety and salient outcomes .

###24673419
BACKGROUND	Myocardial iron overload leading to congestive heart failure ( HF ) or arrhythmias is a recognized complication in thalassemia patients undergoing chronic blood transfusion .
BACKGROUND	The relationship between myocardial iron load , subclinical systolic dysfunction , and clinical events remains less well known .
METHODS	We studied a total of 77 subjects , comprising 37 thalassemia patients ( mean age : 24.2 5.5 years ) with a history of repeated blood transfusions , in addition to 40 age - and gender-matched controls ( mean age : 24 4.5 years ) .
METHODS	Serum ferritin levels were checked in all subjects , as well as semiautomated quantification of left ventricular ( LV ) longitudinal , circumferential , and radial deformations assessed by two-dimensional ( 2D ) speckle tracking analysis .
RESULTS	Compared with the control group , thalassemia patients showed significantly larger LV mass index and lower myocardial deformations ( P < 0.05 ) , but left ventricular ejection fraction ( LVEF ) did not differ significantly ( P = 0.233 ) .
RESULTS	There was a significant linear correlation between serum ferritin level and longitudinal ( r = 0.44 , P = 0.0078 ) and radial strain ( r = -0.46 , P = 0.0051 ) , with optimal cutoff provided to be -15.48 % , -21.31 % , and 26.67 % for longitudinal , circumferential , and radial strain in predicting clinical events , respectively .
RESULTS	During a median of 802.5 days follow-up , 11 clinical composites ( HF incidence , ventricular tachyarrhythmia , and death ) occurred ( N = 9 subjects ) ; subjects with composites had significantly reduced longitudinal and radial strain compared to those without ( both P < 0.05 ) .
RESULTS	After adjusting for age , sex , serum ferritin level , and LV mass index , a worsening of longitudinal strain remained as an independent predictor of clinical events and death ( HR : 6.05 , P = 0.033 ) .
CONCLUSIONS	Subclinical systolic dysfunction appears more likely in thalassemia subjects with a history of repeated blood transfusions , which further correlated with serum ferritin levels .
CONCLUSIONS	In addition , worsening LV myocardial deformation parameters may play an independent role in predicting clinical outcomes beyond traditional measures in this population .

###24853619
OBJECTIVE	To evaluate the efficacy of extracorporeal magnetic innervation ( ExMI ) as a treatment for primary dysmenorrhea compared with nonsteroidal anti-inflammatory drugs ( NSAIDs ) and combined oral contraceptives ( COCs ) .
METHODS	The cases were randomized into three groups ( NSAID = 51 , ExMI = 53 , COC = 54 ) .
METHODS	ExMI was applied for a total of 10 sessions .
METHODS	Women in the NSAID group used an oral NSAID at the start of each menstruation .
METHODS	Women in the COC group were given combined pills .
METHODS	Of the treatment options , ExMI was applied for only a single period , whereas NSAID and COC use continued for 12 months .
RESULTS	At the first menstruation , visual analog scale ( VAS ) scores improved significantly in all groups ( p < 0.001 ) .
RESULTS	NSAIDs and COCs continued to show efficacy over the entire study period ( p < 0.05 ) .
RESULTS	However , in the ExMI group , VAS values increased from the first menstruation until 12 months .
RESULTS	The VAS score at the 12th month was significantly higher in the ExMI group than in the other groups ( p < 0.05 ) , but markedly lower than the pretreatment value ( 49.9 8.3 vs. 71.1 10.1 , p < 0.001 ) .
CONCLUSIONS	ExMI therapy might be a promising novel noninvasive option for primary dysmenorrhea .
CONCLUSIONS	Efficacy began to decline after 3 months , but continued for 12 months .

###26200465
BACKGROUND	Physostigmine , a centrally acting acetylcholinesterase inhibitor , is most commonly used by anesthesiologists in the postanesthetic setting to reverse confusion caused by central anticholinergic medication effects .
BACKGROUND	It has also been proposed as a treatment for sleep-disordered breathing .
BACKGROUND	We investigated whether physostigmine was effective in decreasing the frequency of ventilatory arrhythmias produced during moderate sedation with midazolam and remifentanil during the conditions of breathing room air or 2 L/min nasal O2 .
METHODS	Ten healthy male volunteers participated in this randomized , double-blind control trial of physostigmine ( 0.24 gkgmin ) versus placebo .
METHODS	Moderate sedation was achieved with infusions of midazolam and remifentanil and monitored with full and processed electroencephalogram .
METHODS	Analgesia was quantified with subjective pain score to thermal stimulation .
METHODS	Ventilatory arrhythmias , as measured by the sedation apnea-hypopnea index ( S-AHI ) , were scored as the number of apneas and hypopneas during two 1-hour periods on room air or 2 L/min nasal O2 .
RESULTS	All subjects tolerated the sedation and physostigmine without significant adverse effects .
RESULTS	Sedation during placebo infusion resulted in clinically significant ( S-AHI > 15 ) ventilatory arrhythmias in 5 conditions in 3 subjects ( 2 on room air and then O2 , and 1 on O2 only ) .
RESULTS	Physostigmine did not significantly ( P > 0.46 ) reduce the total number of ventilatory arrhythmias on either room air or O2 ( 13.4 18.8 events/h [ mean SEM ] , 95 % confidence interval [ CI ] = -9.9 to 62.7 ; and 6.2 8.0 , 95 % CI = -3.1 to 28.7 , respectively ) .
RESULTS	Physostigmine did reduce the S-AHI in all 5 instances of clinically significant ventilatory arrhythmias ( S-AHI decreased by 67.0 22.2 ; CI = 29.2-111 .7 ; P = 0.04 ) .
CONCLUSIONS	Physostigmine does not appear to be useful as a pretreatment to prevent ventilatory arrhythmias during moderate sedation .
CONCLUSIONS	However , it may be useful as a treatment for clinically significant ventilatory arrhythmias during moderate sedation .

###24804699
OBJECTIVE	Low HDL cholesterol ( HDL-C ) and small HDL particle size may directly promote hyperglycemia .
OBJECTIVE	We evaluated associations of HDL-C , apolipoprotein A-I ( apoA-I ) , and HDL-C/apoA-I with insulin secretion , insulin resistance , HbA1c , and long-term glycemic deterioration , reflected by initiation of pharmacologic glucose control .
METHODS	The 5-year Fenofibrate Intervention and Event Lowering in Diabetes ( FIELD ) study followed 9,795 type 2 diabetic subjects .
METHODS	We calculated baseline associations of fasting HDL-C , apoA-I , and HDL-C/apoA-I with HbA1c and , in those not taking exogenous insulin ( n = 8,271 ) , with estimated - cell function ( homeostasis model assessment of - cell function [ HOMA-B ] ) and insulin resistance ( HOMA-IR ) .
METHODS	Among the 2,608 subjects prescribed lifestyle only , Cox proportional hazards analysis evaluated associations of HDL-C , apoA-I , and HDL-C/apoA-I with subsequent initiation of oral hypoglycemic agents ( OHAs ) or insulin .
RESULTS	Adjusted for age and sex , baseline HDL-C , apoA-I , and HDL-C/apoA-I were inversely associated with HOMA-IR ( r = -0.233 , -0.134 , and -0.230 ; all P < 0.001 ; n = 8,271 ) but not related to HbA1c ( all P > 0.05 ; n = 9,795 ) .
RESULTS	ApoA-I was also inversely associated with HOMA-B ( r = -0.063 ; P = 0.002 ; n = 8,271 ) adjusted for age , sex , and HOMA-IR .
RESULTS	Prospectively , lower baseline HDL-C and HDL-C/apoA-I levels predicted greater uptake ( per 1-SD lower : hazard ratio [ HR ] 1.13 [ CI 1.07-1 .19 ] , P < 0.001 ; and HR 1.16 [ CI 1.10-1 .23 ] , P < 0.001 , respectively ) and earlier uptake ( median 12.9 and 24.0 months , respectively , for quartile 1 vs. quartile 4 ; both P < 0.01 ) of OHAs and insulin , with no difference in HbA1c thresholds for initiation ( P = 0.87 and P = 0.81 ) .
RESULTS	Controlling for HOMA-IR and triglycerides lessened both associations , but HDL-C/apoA-I remained significant .
CONCLUSIONS	HDL-C , apoA-I , and HDL-C/apoA-I were associated with concurrent insulin resistance but not HbA1c .
CONCLUSIONS	However , lower HDL-C and HDL-C/apoA-I predicted greater and earlier need for pharmacologic glucose control .

###24462568
BACKGROUND	The obesity epidemic has spread to young adults , leading to significant public health implications later in adulthood .
BACKGROUND	Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic .
BACKGROUND	Few weight loss trials have been conducted in young adults .
BACKGROUND	It is unclear what weight loss strategies are beneficial in this population .
OBJECTIVE	To describe the design and rationale of the NHLBI-sponsored Cell Phone Intervention for You ( CITY ) study , which is a single center , randomized three-arm trial that compares the impact on weight loss of 1 ) a behavioral intervention that is delivered almost entirely via cell phone technology ( Cell Phone group ) ; and 2 ) a behavioral intervention delivered mainly through monthly personal coaching calls enhanced by self-monitoring via cell phone ( Personal Coaching group ) , each compared to 3 ) a usual care , advice-only control condition .
METHODS	A total of 365 community-dwelling overweight/obese adults aged 18-35 years were randomized to receive one of these three interventions for 24 months in parallel group design .
METHODS	Study personnel assessing outcomes were blinded to group assignment .
METHODS	The primary outcome is weight change at 24 [ corrected ] months .
METHODS	We hypothesize that each active intervention will cause more weight loss than the usual care condition .
METHODS	Study completion is anticipated in 2014 .
CONCLUSIONS	If effective , implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss .
CONCLUSIONS	ClinicalTrial.gov : NCT01092364 .

###24411804
OBJECTIVE	Subjective responses to alcohol represent a biologically based , genetically moderated , and clinically informative marker of alcoholism risk ; however , the physiology underlying this phenotype remains unclear .
OBJECTIVE	This study tested whether subjective responses during alcohol administration predict neural responses to alcohol cues in the scanner and whether these neural responses differ between OPRM1 genotypes .
METHODS	Twenty alcohol-dependent individuals were recruited ( 10 G-allele carriers ; 6 women ; Mage = 29.4 ) for a within-subjects alcohol administration in the laboratory and a functional magnetic resonance imaging session consisting of an alcohol taste cues task .
METHODS	Laboratory assessments of alcohol high , liking , craving , and positive and negative reinforcement during alcohol administration were entered as predictors of neural response to the presentation of alcohol cues versus water cues in the scanner and further tested for OPRM1 genotype moderation ( whole-brain cluster-corrected at Z > 1.96 , p < .05 ) .
RESULTS	Alcohol craving during alcohol administration predicted less neural activity , whereas alcohol reinforcement predicted greater neural activity to alcohol cues versus water cues in regions including the precuneus , posterior cingulate gyrus , and lingual gyrus .
RESULTS	Alcohol high predicted greater neural activity to alcohol cues in regions including the precuneus and anterior cingulate cortex .
RESULTS	OPRM1 genotype was found to moderate these relationships .
RESULTS	No results were observed for alcohol liking .
CONCLUSIONS	This study provides initial evidence that subjective responses to alcohol , namely craving , high , and the reinforcing properties of alcohol , predict neural markers of alcohol cue reactivity .
CONCLUSIONS	These results support the validity of laboratory and neuroimaging measures of subjective responses to alcohol and offer an integration of these methods in a sample of alcohol-dependent individuals .

###25595352
BACKGROUND	Vitamin D co-regulates the synthesis of sex hormones in part by interaction with its nuclear receptor .
BACKGROUND	The aim of this study was to determine whether there is an association of vitamin D concentration vs the level of sex hormones in elderly Polish individuals with different genotypes of the vitamin D receptor ( VDR ) gene .
METHODS	Rs10735810 , rs1544410 , rs7975232 , and rs731236 polymorphisms of VDR , the serum sex hormone level , free estrogen index ( FEI ) and free androgen index ( FAI ) as well as vitamin D , were evaluated in 766 persons ( 362 women and 404 men ) selected from 5695 Polish population , aged 65-90years from the PolSenior survey .
RESULTS	We observed that women with GG ( rs731236 ) , TT ( rs7975232 ) , BB ( rs1544410 ) and FF ( rs10735810 ) genotypes were characterized by a significant correlation between vitamin D vs testosterone concentration and FAI value .
RESULTS	We found a significant correlation between testosterone level and FAI vs vitamin D concentration in men with heterozygote AG in the rs731236 polymorphism and in the GG ( rs7975232 ) , the BB ( rs1544410 ) , and the Ff ( rs10735810 ) genotypes .
CONCLUSIONS	In elderly selected Polish population with different genotypes of VDR polymorphisms , a statistically significant relationship between vitamin D concentration vs testosterone level was observed .

###25895016
OBJECTIVE	Evidence of effective treatment of childhood obesity in primary care settings is limited .
OBJECTIVE	To examine the extent to which computerized clinical decision support ( CDS ) delivered to pediatric clinicians at the point of care of obese children , with or without individualized family coaching , improved body mass index ( BMI ; calculated as weight in kilograms divided by height in meters squared ) and quality of care .
METHODS	We conducted a cluster-randomized , 3-arm clinical trial .
METHODS	We enrolled 549 children aged 6 to 12 years with a BMI at the 95 % percentile or higher from 14 primary care practices in Massachusetts from October 1 , 2011 , through June 30 , 2012 .
METHODS	Patients were followed up for 1 year ( last follow-up , August 30 , 2013 ) .
METHODS	In intent-to-treat analyses , we used linear mixed-effects models to account for clustering by practice and within each person .
METHODS	In 5 practices randomized to CDS , pediatric clinicians received decision support on obesity management , and patients and their families received an intervention for self-guided behavior change .
METHODS	In 5 practices randomized to CDS + coaching , decision support was augmented by individualized family coaching .
METHODS	The remaining 4 practices were randomized to usual care .
METHODS	Smaller age-associated change in BMI and the Healthcare Effectiveness Data and Information Set ( HEDIS ) performance measures for obesity during the 1-year follow-up .
RESULTS	At baseline , mean ( SD ) patient age and BMI were 9.8 ( 1.9 ) years and 25.8 ( 4.3 ) , respectively .
RESULTS	At 1 year , we obtained BMI from 518 children ( 94.4 % ) and HEDIS measures from 491 visits ( 89.4 % ) .
RESULTS	The 3 randomization arms had different effects on BMI over time ( P = .04 ) .
RESULTS	Compared with the usual care arm , BMI increased less in children in the CDS arm during 1 year ( -0.51 [ 95 % CI , -0.91 to -0.11 ] ) .
RESULTS	The CDS + coaching arm had a smaller magnitude of effect ( -0.34 [ 95 % CI , -0.75 to 0.07 ] ) .
RESULTS	We found substantially greater achievement of childhood obesity HEDIS measures in the CDS arm ( adjusted odds ratio , 2.28 [ 95 % CI , 1.15-4 .53 ] ) and CDS + coaching arm ( adjusted odds ratio , 2.60 [ 95 % CI , 1.25-5 .41 ] ) and higher use of HEDIS codes for nutrition or physical activity counseling ( CDS arm , 45 % ; CDS + coaching arm , 25 % ; P < .001 compared with usual care arm ) .
CONCLUSIONS	An intervention that included computerized CDS for pediatric clinicians and support for self-guided behavior change for families resulted in improved childhood BMI .
CONCLUSIONS	Both interventions improved the quality of care for childhood obesity .
BACKGROUND	clinicaltrials.gov Identifier : NCT01537510 .

###25437496
BACKGROUND	Recent studies have shown that neutrophils may display an antigen-presenting function and inhibit lymphocyte proliferation by expressing programmed cell death 1 ligand 1 ( PD-L1 ) .
BACKGROUND	The current study was performed to investigate the effect of neutrophils and their pathophysiological significance during sepsis .
METHODS	Neutrophil PD-L1 expression was determined in both septic mice ( n = 6 ) and patients ( n = 41 ) .
METHODS	Neutrophils from septic mice were subtyped into PD-L1 and PD-L1 populations to determine their phenotypes and functions .
METHODS	Septic neutrophils were cocultured with lymphocytes to observe the effect of septic neutrophils on lymphocyte apoptosis .
RESULTS	The PD-L1 level on neutrophils from septic mice was significantly up-regulated ( 21.41 4.76 % ) .
RESULTS	This level increased with the progression of sepsis and the migration of neutrophils from the bone marrow to the blood and peritoneal cavity .
RESULTS	The percentages of CD11a , CD62L , and C-C chemokine receptor type 2 were lower , whereas the percentages of CD16 and CD64 were higher on PD-L1 neutrophils than on PD-L1 neutrophils .
RESULTS	The migratory capacity of PD-L1 neutrophils was compromised .
RESULTS	Septic neutrophils induced lymphocyte apoptosis via a contact mechanism , and this process could be reversed by anti-PD-L1 antibody .
RESULTS	PD-L1 was also up-regulated on neutrophils from patients with severe sepsis ( 14.6 % [ 3.75 % , 42.1 % ] ) .
RESULTS	The levels were negatively correlated with the monocyte human leukocyte antigen-DR level and positively correlated with the severity of septic patients .
RESULTS	Neutrophil PD-L1 was a predictor for the prognosis of severe sepsis , with an area of 0.74 under the receiver operating curve .
CONCLUSIONS	PD-L1 is up-regulated on neutrophils during sepsis , which may be related to sepsis-induced immunosuppression .

###24861492
BACKGROUND	Daylight photodynamic therapy ( DL-PDT ) of actinic keratosis ( AK ) has shown preliminary efficacy and safety results comparable to conventional photodynamic therapy ( c-PDT ) , using methyl aminolevulinate ( MAL ) cream .
OBJECTIVE	To demonstrate the efficacy and safety of DL-PDT vs. c-PDT in treating mild facial/scalp AK .
METHODS	This 24-week randomized , controlled , investigator-blinded , multicentre , intra-individual efficacy ( non-inferiority ) and safety ( superiority regarding pain ) study enrolled 100 subjects .
METHODS	AKs on the face/scalp were treated once , with DL-PDT on one side and c-PDT on the contralateral side .
METHODS	Primary end points for DL-PDT at week 12 were efficacy [ non-inferiority regarding complete lesion response ( mild AK ) ] and safety ( superiority regarding subject 's assessment of pain ) .
METHODS	Lesions with complete response 12weeks after one treatment session were followed until week 24 .
METHODS	The safety evaluation included incidence of adverse events .
METHODS	Subject satisfaction was classified using a questionnaire .
RESULTS	At week 12 , the complete lesion response rate with DL-PDT was non-inferior to c-PDT ( 892 % vs. 928 % , respectively ; 95 % confidence interval -68 to -03 ) , confirmed by intention-to-treat analysis .
RESULTS	Additionally , regardless of the treatment used , 96 % of mild lesions were maintained in complete response 24weeks after the PDT session .
RESULTS	For DL-PDT , subject-reported pain was significantly lower ( 08 vs. 57 , respectively ; P < 0001 ) , with better tolerability and significantly higher subject satisfaction regarding convenience and outcome .
CONCLUSIONS	Daylight-mediated PDT was not inferior in efficacy to Metvix c-PDT ( mild AK response rate ) , better tolerated , nearly painless and more convenient for patients .

###24961378
BACKGROUND	Brief motivational intervention ( BMI ) has shown promising results to reduce alcohol use in young adults .
BACKGROUND	Knowledge on mechanisms that predict BMI efficacy could potentially improve treatment effect sizes through data that optimize clinical training and implementation .
BACKGROUND	Particularly , little attention has been given to counselor influence on treatment mechanisms .
METHODS	We investigated the influence of counselors on BMI efficacy in reducing alcohol use among non-treatment-seeking young men ( age 20 ) screened as hazardous drinkers .
METHODS	Participants were randomly allocated to ( i ) a group receiving a single BMI from 1 of 18 counselors selected to maximize differences in several of their characteristics ( gender , professional status , clinical experience , and motivational interviewing [ MI ] experience ) or ( ii ) a control group receiving assessment only .
METHODS	Drinking at 3-month follow-up was first compared between the BMI and control groups to assess efficacy .
METHODS	Then , the influence of counselors ' characteristics ( i.e. , gender , professional status , clinical experience , MI experience , BMI attitudes , and expectancies ) and within-session behaviors ( i.e. , measured by the Motivational Interviewing Skill Code ) on outcome was tested in regression analyses .
RESULTS	There was a significant ( p = 0.02 ) decrease in alcohol use among the BMI group compared to the control group .
RESULTS	Counselors that were male , more experienced , that had more favorable BMI attitudes and expectancies , higher MI skills , but surprisingly less MI-consistent behaviors , had significantly better outcomes than the control group while their counterparts did not .
CONCLUSIONS	The current study demonstrated BMI efficacy on alcohol use reduction within a sample of non-treatment-seeking young adult males .
CONCLUSIONS	Moreover , BMI effect was related to interindividual differences among counselors , and results therefore provide recommendations for BMI training and implementation with similar populations .

###24636483
OBJECTIVE	Second-generation antipsychotics ( SGAs ) are among the first-line treatments for bipolar disorder and schizophrenia , but have a tendency to generate metabolic disturbances .
OBJECTIVE	These features resemble a metabolic syndrome for which a central autonomic imbalance has been proposed that may originate from the hypothalamic suprachiasmatic nuclei .
OBJECTIVE	In a clinical trial , we hypothesized that melatonin , a hormone that regulates the suprachiasmatic nucleus , could attenuate SGA-induced adverse metabolic effects .
METHODS	In an eight-week , double-blind , randomized , placebo-controlled , parallel-group clinical trial , we evaluated the metabolic effect of melatonin in SGA-treated patients in terms of weight , blood pressure , lipid , glucose , body composition , and anthropometric measures .
METHODS	A total of 44 patients treated with SGAs , 20 with bipolar disorder and 24 with schizophrenia , randomly received placebo ( n = 24 ) or melatonin 5 mg ( n = 20 ) .
RESULTS	The melatonin group showed a decrease in diastolic blood pressure ( 5.1 versus 1.1 mmHg for placebo , p = 0.003 ) and attenuated weight gain ( 1.5 versus 2.2 kg for placebo , F = 4.512 , p = 0.040 ) compared to the placebo group .
RESULTS	The strong beneficial metabolic effects of melatonin in comparison to placebo on fat mass ( 0.2 versus 2.7 kg , respectively , p = 0.032 ) and diastolic blood pressure ( 5.7 versus 5.5 mmHg , respectively , p = 0.001 ) were observed in the bipolar disorder and not in the schizophrenia group .
RESULTS	No adverse events were reported .
CONCLUSIONS	Our results show that melatonin is effective in attenuating SGAs ' adverse metabolic effects , particularly in bipolar disorder .
CONCLUSIONS	The clinical findings allow us to propose that SGAs may disturb a centrally mediated metabolic balance that causes adverse metabolic effects and that nightly administration of melatonin helps to restore .
CONCLUSIONS	Melatonin could become a safe and cost-effective therapeutic option to attenuate or prevent SGA metabolic effects .

###24237610
BACKGROUND	EP42675 is a first-in-class , synthetic , parenteral , anticoagulant combining in a single molecule a direct thrombin inhibitor and an indirect factor Xa ( FXa ) inhibitor .
OBJECTIVE	To investigate the safety , pharmacokinetics , and pharmacodynamics of EP42675 and its interaction with aspirin , clopidogrel , and unfractionated heparin ( UFH ) .
METHODS	In study 1 , healthy male subjects were administered intravenously single-ascending doses ( 1-10 mg ) of EP42675 or placebo .
METHODS	In study 2 , healthy male subjects were administered intravenously a single dose of 5 mg EP42675 on day 1 followed by oral administration of aspirin ( 100 mg ) and clopidogrel ( 75 mg ) once daily from day 8 to 21 .
METHODS	On day 15 , a second dose of 5 mg EP42675 was administered , and subjects were then randomized to receive a single dose of UFH ( 30 or 60 IU kg ( -1 ) ) or placebo .
CONCLUSIONS	Mild bleedings were the only drug-related adverse events .
CONCLUSIONS	EP42675 pharmacokinetics were dose-proportional and characterized by a low clearance , a small volume of distribution , a long terminal half-life .
CONCLUSIONS	EP42675 pharmacodynamics were characterized by a long-lasting , dose-dependent increase in activated clotting time , ecarin clotting time , thrombin time , anti-FXa activity , activated partial thromboplastin time , prothrombin time , and a decrease in endogenous thrombin potential , measured by a thrombin generation test .
CONCLUSIONS	Dose-dependent additive effects were seen with UFH on coagulation tests .
CONCLUSIONS	EP42675 had no additive effect on the inhibition of platelet aggregation induced by aspirin and clopidogrel .
CONCLUSIONS	These results warrant further clinical development of this new class of anticoagulant .

###24352085
OBJECTIVE	Perinatal hypoxia-induced free radical formation is an important cause of hypoxic-ischaemic encephalopathy and subsequent neurodevelopmental disabilities .
OBJECTIVE	Allopurinol reduces the formation of free radicals , which potentially limits hypoxia-induced brain damage .
OBJECTIVE	We investigated placental transfer and safety of allopurinol after maternal allopurinol treatment during labour to evaluate its potential role as a neuroprotective agent in suspected fetal hypoxia .
METHODS	We used data from a randomised , double-blind multicentre trial comparing maternal allopurinol versus placebo in case of imminent fetal hypoxia ( NCT00189007 ) .
METHODS	We studied 58 women in labour at term , with suspected fetal hypoxia prompting immediate delivery , in the intervention arm of the study .
METHODS	Delivery rooms of 11 Dutch hospitals .
METHODS	500 mg allopurinol , intravenously to the mother , immediately prior to delivery .
METHODS	Drug disposition ( maternal plasma concentrations , cord blood concentrations ) and drug safety ( maternal and fetal adverse events ) .
RESULTS	Within 5 min after the end of maternal allopurinol infusion , target plasma concentrations of allopurinol of 2 mg/L were present in cord blood .
RESULTS	Of all analysed cord blood samples , 95 % ( 52/55 ) had a target allopurinol plasma concentration at the moment of delivery .
RESULTS	No adverse events were observed in the neonates .
RESULTS	Two mothers had a red and/or painful arm during infusion .
CONCLUSIONS	A dose of 500 mg intravenous allopurinol rapidly crosses the placenta and provides target concentrations in 95 % of the fetuses at the moment of delivery , which makes it potentially useful as a neuroprotective agent in perinatology with very little side effects .
BACKGROUND	The study is registered in the Dutch Trial Register ( NTR1383 ) and the Clinical Trials protocol registration system ( NCT00189007 ) .

###25041111
BACKGROUND	A limited number of adrenaline auto-injectors are currently available .
BACKGROUND	Epipen and Anapen are available in Australia , New Zealand , UK and parts of Europe and Asia .
BACKGROUND	Few studies have compared the performance of these devices .
OBJECTIVE	To compare the intuitiveness of use of these devices .
OBJECTIVE	A secondary aim was to compare the ability to recall the use of each device after a period of 3months .
METHODS	A random sample of 100 subjects nave to both the EpiPen and Anapen were recruited from staff and families attending Royal Children 's Hospital , Melbourne Australia .
METHODS	Subjects were randomized to Anapen ( n = 53 ) or EpiPen ( n = 47 ) and asked to demonstrate use of a ` trainer ' device ( i ) prior to and ( ii ) after receiving training in its correct use .
METHODS	A subset ( n = 32 ) participated in a follow-up study to evaluate ( iii ) the ability to recall correct use of each device .
RESULTS	Most subjects correctly demonstrated all steps in use of the EpiPen and Anapen both prior to ( 89 % vs. 79 % , p = 0.17 ) and after training on use ( 100 % vs. 100 % ) .
RESULTS	However , after 3months , significantly more participants correctly demonstrated use of EpiPen ( 87 % ) compared to Anapen ( 35 % ) ( p = 0.003 ) and critical errors that would likely result in failure to administer adrenaline were more common with Anapen ( 59 % vs. 13 % , p = 0.01 ) .
CONCLUSIONS	Most study participants correctly demonstrated the use of both devices without prior training .
CONCLUSIONS	There was greater attrition in correct use of Anapen compared to EpiPen over time .
CONCLUSIONS	Critical errors in administration were more likely with Anapen than EpiPen .

###25231240
BACKGROUND	Pelvic organ prolapse is a common health problem : the lifetime risk of undergoing surgery for pelvic organ prolapse by the age of 85 years is 19 % .
BACKGROUND	Pelvic organ prolapse has significant negative effects on a woman 's quality of life .
BACKGROUND	Worldwide , vaginal hysterectomy is the leading treatment method for patients with symptomatic uterovaginal prolapse .
BACKGROUND	Several studies have shown that vaginal sacrospinous hysteropexy and laparoscopic sacrohysteropexy are safe and effective alternatives in treating uterine descent .
BACKGROUND	To date , it is unclear which of these techniques leads to the best operative result and the highest patient satisfaction .
BACKGROUND	Therefore , we conducted the LAVA trial .
METHODS	The LAVA trial is a randomized controlled multicenter non-inferiority trial .
METHODS	The study compares laparoscopic sacrohysteropexy with vaginal sacrospinous hysteropexy in women with uterine prolapse stage 2 or higher .
METHODS	The primary outcome of this study is surgical success of the apical compartment at 1 and 5 years follow-up .
METHODS	Secondary outcomes are subjective improvement on urogenital symptoms and quality of life ( assessed by disease-specific and general quality of life questionnaires ) , complications following surgery , hospital stay , post-operative recovery , sexual functioning and costs-effectiveness .
METHODS	Evaluation will take place pre-operatively , and 6 weeks , 6 months , 12 months and annually till 60 months after surgery .
METHODS	Validated questionnaires will be used.Analysis will be performed according to the intention to treat principle .
METHODS	Based on comparable recurrence rates of 3 % and a non-inferiority margin of 10 % , 62 patients are needed in each arm to prove the hypothesis with a 95 % confidence interval .
CONCLUSIONS	The LAVA trial is a randomized controlled multicenter non-inferiority trial that will provide evidence whether the efficacy of laparoscopic sacrohysteropexy is non-inferior to vaginal sacrospinous hysteropexy in women with symptomatic uterine prolapse stage 2 or higher .
BACKGROUND	Netherlands Trial Register ( NTR ) : NTR4029 .

###25075894
BACKGROUND	Since its introduction in 2007 , the use of 8-plates has gained great popularity for the correction of diverse deformities in skeletally immature patients .
BACKGROUND	In this study , we evaluate 2 different techniques of implant placement .
METHODS	A consecutive series of patients with indication of guided growth around the knee ( femur or tibia ) were included in the study .
METHODS	Patients were randomly divided in 2 groups , with 8-plate inserted using technique as described by Stevens ( group A ) versus technique modified from Paley ( group B ) .
METHODS	We analyzed operative time , radiation exposure , incision size , and intraoperative complications .
METHODS	Comparisons between groups were performed with a Mann-Whitney test .
METHODS	A 2-tailed P-value < 0.05 was considered significant .
RESULTS	We evaluated a total of 31 procedures in 18 patients ( 16 in group A and 15 in group B ) .
RESULTS	Age and sex was similar in both groups ( P = 0.470 and 0.720 ) .
RESULTS	Operative time and radiation exposure was significantly lower in group B : 20 minutes ( range , 11.37 to 29.30 min ) versus 13.09 minutes ( range , 9.31 to 25 min ) ( P 0.009 ) , and 0.30 Gy ( range , 0.10 to 1.30 Gy ) versus 0.10 Gy ( range , 0.00 to 0.70 Gy ) ( P = 0.013 ) , respectively .
RESULTS	The incision size was also smaller in group B : 27 mm ( range , 23 to 29 mm ) versus 23 mm ( range , 18 to 24 mm ) ( P = 0.05 ) .
RESULTS	There were no intraoperative complications in any of the 2 groups .
CONCLUSIONS	Modified technique for 8-plate placement seems to reduce operative time , radiation exposure , and incision size for guided growth around the knee .
METHODS	Level of evidence II-prospective randomized study .

###25159546
BACKGROUND	Fast-track program has been applied in several surgical fields .
BACKGROUND	However , currently many surgical patients are elderly over 70 years of age , and discussion about the application of such protocols for elderly patients is inadequate .
METHODS	The present study was designed to consider the safety and feasibility of application of a fast-track program after colorectal surgery in elderly patients .
METHODS	A total of 76 elderly patients with colorectal cancer who underwent laparoscopic colorectal resection were randomly assigned to receive either the fast-track care program ( n = 40 ) or the conventional perioperative care protocol ( control group , n = 36 ) .
METHODS	The fast track protocol included no preoperative mechanical bowel irrigation , immediate oral alimentation and earlier postoperative ambulation exercise .
METHODS	The length of postoperative hospital stay , the length of time to regain bowel function and the rate of postoperative complications were compared between the two groups .
RESULTS	The length of time to regain bowel function , including the passage of flatus [ 32 ( 24-40 ) h vs 42 ( 32-52 ) h ] , and to start a liquid diet ( 13 [ 10-16 ] h v/s 43 [ 36-50 ] h ) were significantly shorter in patients receiving the fast track care protocol compared with those receiving the conventional care protocol .
RESULTS	A shorter duration of postoperative hospital stay was recorded in patients receiving the fast-track program than in those receiving conventional care [ 6 ( 5-7 ) days v/s 9.5 ( 7-12 ) days ] .
RESULTS	A reduced percentage of patients who developed general complications was also observed in the fast-track group ( 5.0 % v/s 18 % ) .
CONCLUSIONS	Fast-track after laparoscopic colorectal surgery can be safely applied in carefully selected elderly patients older than age 70 years .
CONCLUSIONS	The fast-track recovery program resulted in a more rapid postoperative recovery , earlier discharge from hospital and fewer general complications compared with a conventional postoperative protocol .

###25454942
OBJECTIVE	To test the hypothesis that inhaled nitric oxide ( iNO ) would lead to improved oxygenation and a decrease in duration of mechanical ventilation in pediatric patients with acute respiratory distress syndrome .
METHODS	A total of 55 children with acute respiratory distress syndrome were enrolled from 9 centers .
METHODS	Patients were randomized to iNO or placebo and remained on the study drug until death , they were free of ventilator support , or day 28 after the initiation of therapy .
RESULTS	Mean baseline oxygenation indexes ( OIs ) were 22.0 18.4 and 25.6 14.9 ( iNO and placebo groups , respectively , P = .27 ) .
RESULTS	There was a trend toward an improved OI in the iNO group compared with the placebo group at 4 hours that became significant at 12 hours .
RESULTS	There was no difference in the OI between groups at 24 hours .
RESULTS	Days alive and ventilator free at 28 days was greater in the iNO group , 14.2 8.1 and 9.1 9.5 days ( iNO and placebo groups , respectively , P = .05 ) .
RESULTS	Although overall survival at 28 days failed to reach statistical significance , 92 % ( 22 of 24 ) in the iNO group and 72 % ( 21 of 29 ) in the placebo group ( P = .07 ) , the rate of extracorporeal membrane oxygenation-free survival was significantly greater in those randomized to iNO 92 % ( 22 of 24 ) vs 52 % ( 15 of 29 ) for those receiving placebo ( P < .01 ) .
CONCLUSIONS	The use of iNO was associated with a significantly reduced duration of mechanical ventilation and significantly greater rate of extracorporeal membrane oxygenation-free survival .

###25547503
OBJECTIVE	To compare the clinical outcomes of sorafenib plus either erlotinib or placebo in patients with advanced hepatocellular carcinoma ( HCC ) in a multicenter , multinational , randomized , phase III trial .
METHODS	Patients with advanced HCC and underlying Child-Pugh class A cirrhosis , who were naive to systemic treatment ( N = 720 ) , were randomly assigned to sorafenib plus either erlotinib ( n = 362 ) or placebo ( n = 358 ) .
METHODS	The primary end point was overall survival ( OS ) .
RESULTS	Median OS was similar in the sorafenib plus erlotinib and sorafenib plus placebo groups ( 9.5 v 8.5 months , respectively ; hazard ratio [ HR ] , 0.929 ; P = .408 ) , as was median time to progression ( 3.2 v 4.0 months , respectively ; HR , 1.135 ; P = .18 ) .
RESULTS	In the sorafenib/erlotinib arm versus the sorafenib/placebo arm , the overall response rate trended higher ( 6.6 % v 3.9 % , respectively ; P = .102 ) , whereas the disease control rate was significantly lower ( 43.9 % v 52.5 % , respectively ; P = .021 ) .
RESULTS	The median durations of treatment with sorafenib were 86 days in the sorafenib/erlotinib arm and 123 days in the sorafenib/placebo arm .
RESULTS	In the sorafenib/erlotinib and sorafenib/placebo arms , the rates of treatment-emergent serious AEs ( 58.0 % v 54.6 % , respectively ) and drug-related serious AEs ( 21.0 % v 22.8 % , respectively ) were similar .
RESULTS	AEs matched the known safety profiles of both agents , but rates of rash/desquamation , anorexia , and diarrhea were higher in the sorafenib/erlotinib arm , whereas rates of alopecia and hand-foot skin reaction were higher in the sorafenib/placebo arm .
RESULTS	Withdrawal rates for AEs during cycles 1 to 3 were higher in the sorafenib/erlotinib arm .
CONCLUSIONS	Adding erlotinib to sorafenib did not improve survival in patients with advanced HCC .

###24738517
OBJECTIVE	Human 's life as well as medical professions consist of many moral dilemmas .
OBJECTIVE	The aim of our study was to evaluate moral competences of midwifery students during their whole university education ( 3 year course ) based on their moral competences C-index .
METHODS	We performed randomized single blinded 3-year follow-up trial of 72 midwifery students .
METHODS	Standard Moral Judgment Test ( MJT ) By Georg Lind was used accompanied by own questionnaire .
METHODS	Moral competences were calculated ( C-index ) according to Lind 's methodology .
METHODS	Subjects were also divided into active and passive ethics training to search for differences .
RESULTS	C-index varied during studies insignificant ( p = 0.14 ) .
RESULTS	Randomized groups were equal at the beginning point , no significant differences were noticed .
RESULTS	Active ethics teaching did not increase C-index compared to controls in all measuring points ( P1-P4 , respectively p = 0,41 and p = 0,38 ) .
CONCLUSIONS	During 3 year studies at medical university moral competences measured by C-index varied insignificantly , but simultaneously the change in C-index was dependent on its value at the beginning of the trial .
CONCLUSIONS	There was not statistically significant influence of active ethic 's teaching compared to controls .
CONCLUSIONS	Among social factors parents have strongest influence on students ' morality , but growing role of Medical University in this hierarchy raises hopes for improvement in effectiveness of training in ethics .

###25867274
BACKGROUND	The aim of this study was to examine whether EndoPredict ( EP ) , a novel genomic expression test , is effective in predicting local recurrence ( LR ) - free survival ( LRFS ) following surgery for breast cancer in postmenopausal women .
BACKGROUND	In addition , we examined whether EP may help tailor local therapy in these patients .
METHODS	From January 1996 to June 2004 , 3714 postmenopausal patients were randomly assigned to either tamoxifen or tamoxifen followed by anastrozole within the prospective ABCSG 8 trial .
METHODS	Using assay scores from EP , we classified breast tumour blocks as either low or high risk for recurrence .
RESULTS	Data were gathered from 1324 patients .
RESULTS	The median follow-up was 72.3 months and the cumulative incidence of LR was 2.6 % ( 0.4 % per year ) .
RESULTS	The risk of LR over a 10-year period among patients with high-risk lesions ( n = 683 ) was significantly higher ( LRFS = 91 % ) when compared with patients with low-risk lesions ( n = 641 ) ( 10-year LRFS = 97.5 % ) ( HR : 1.31 ( 1.16-1 .48 ) P < 0.005 ) .
RESULTS	The groups that received breast conservation surgery ( BCT ) and mastectomy ( MX ) had similar LR rates ( P = 0.879 ) .
RESULTS	Radiotherapy ( RT ) after BCT significantly improved LRFS in the cohorts predicted by EP to be low-risk for LR ( received RT : n = 436 , 10-year LRFS 99.8 % ; did not receive RT : n = 63 , 10-year LRFS 83.6 % , P < 0.005 ) .
CONCLUSIONS	EndoPredict is an effective prognostic tool for predicting LRFS .
CONCLUSIONS	Among postmenopausal , low-risk patients , EP does not appear to be useful for tailoring local therapy .

###24512486
BACKGROUND	Somatostatin ( SST ) receptors ( SSTRs ) are expressed in a number of tissues , including the adrenal cortex , but their role in cortisol secretion has not been well characterized .
OBJECTIVE	The objective of the study was to investigate the expression of SSTRs in the adrenal cortex and cultured adrenocortical cells from primary pigmented nodular adrenocortical disease ( PPNAD ) tissues and to test the effect of a single injection of 100 g of the SST analog octreotide on cortisol secretion in patients with PPNAD .
METHODS	The study was conducted at an academic research laboratory and clinical research center .
METHODS	Expression of SSTRs was examined in 26 PPNAD tissues and the immortalized PPNAD cell line CAR47 .
METHODS	Ten subjects with PPNAD underwent a randomized , single-blind , crossover study of their cortisol secretion every 30 minutes over 12 hours ( 6:00 pm to 6:00 am ) before and after the midnight administration of octreotide 100 g sc .
METHODS	SSTRs expression was investigated by quantitative PCR and immunohistochemistry .
METHODS	The CAR47 and primary cell lines were studied in vitro .
METHODS	The data of the 10 patients were analyzed before and after the administration of octreotide .
RESULTS	All SSTRs , especially SSTR1-3 , were expressed in PPNAD at significantly higher levels than in normal adrenal .
RESULTS	SST was found to differentially regulate expression of its own receptors in the CAR47 cell line .
RESULTS	However , the administration of octreotide to patients with PPNAD did not significantly affect cortisol secretion .
CONCLUSIONS	SSTRs are overexpressed in PPNAD tissues in comparison with normal adrenal cortex .
CONCLUSIONS	Octreotide did not exert any significant effect on cortisol secretion in a short clinical pilot study in a small number of patients with PPNAD , but long-acting SST analogs targeting multiple SSTRs may be worth investigating in this condition .

###25001947
BACKGROUND	By the age of sixteen , one in five children will sustain a mild traumatic brain injury also known as concussion .
BACKGROUND	Our research found that one in seven school children with mild traumatic brain injury suffer post-concussion syndrome symptoms for three months or longer .
BACKGROUND	Post-concussion syndrome is associated with significant disability in the child and his/her family and yet there are no evidence-based medical treatments available .
BACKGROUND	Melatonin has several potential mechanisms of action that could be useful following mild traumatic brain injury , including neuroprotective effects .
BACKGROUND	The aim of this study is to determine if treatment with melatonin improves post-concussion syndrome in youths following mild traumatic brain injury .
BACKGROUND	Our hypothesis is that treatment of post-concussion syndrome following mild traumatic brain injury with 3 or 10 mg of sublingual melatonin for 28 days will result in a decrease in post-concussion syndrome symptoms compared with placebo .
METHODS	Ninety-nine youths with mild traumatic brain injury , aged between 13 and 18 years , who are symptomatic at 30 days post-injury will be recruited .
METHODS	This study will be conducted as a randomized , double blind , placebo-controlled superiority trial of melatonin .
METHODS	Three parallel treatment groups will be examined with a 1:1:1 allocation : sublingual melatonin 3 mg , sublingual melatonin 10 mg , and sublingual placebo .
METHODS	Participants will receive treatment for 28 days .
METHODS	The primary outcome is a change on the Post-Concussion Symptom Inventory ( Parent and Youth ) .
METHODS	The secondary outcomes will include neurobehavioral function , health-related quality of life and sleep .
METHODS	Neurophysiological and structural markers of change , using magnetic resonance imaging techniques and transcranial magnetic stimulation , will also be investigated .
CONCLUSIONS	Melatonin is a safe and well-tolerated agent that has many biological properties that may be useful following a traumatic brain injury .
CONCLUSIONS	This study will determine whether it is a useful treatment for children with post-concussion syndrome .
CONCLUSIONS	Recruitment commenced on 4 December 2014 .
BACKGROUND	This trial was registered on 6 June 2013 at ClinicalTrials.gov .
BACKGROUND	NCT01874847 .

###25675385
BACKGROUND	Glucagon-like peptide-1 ( GLP-1 ) analogs have recently been promoted as antihyperglycemic agents in critically ill patients with systemic inflammation , but the effects of TNF - on glucose metabolism during GLP-1 administration are unknown .
OBJECTIVE	The objective of the study was to determine whether the infusion of TNF - at high physiological levels impairs GLP-1 's effects on glucose metabolism .
METHODS	This was a randomized , controlled , cross-over trial .
METHODS	The study was conducted at a hospital clinical research laboratory .
METHODS	Twelve healthy males ( aged 24 3 y ; body mass index 22.9 1.3 kg/m ( 2 ) ) .
METHODS	After an overnight fast , either saline ( 0.9 % ) or recombinant human TNF - ( 1000 ng/m ( 2 ) h ) was infused from t = 0-6 hours .
METHODS	At t = 2 hours , GLP-1 infusion ( 0.5 pmol/kg min ) began .
METHODS	From t = 4-6 hours , the GLP-1 infusion rate was increased to 1.2 pmol/kg min .
METHODS	Plasma glucose was clamped at 5 mmol/L throughout via a variable rate 20 % dextrose infusion .
METHODS	Trials were 7-14 days apart .
METHODS	Endogenous glucose production ( EGP ) was measured by the [ 6,6 - ( 2 ) H2 ] glucose isotope tracer dilution method .
RESULTS	GLP-1 infusion suppressed plasma glucagon ( P < .01 ) , elevated plasma insulin , and C-peptide ( P < .01 ) and suppressed EGP ( P < .001 ) during the saline infusion .
RESULTS	In contrast , the infusion of TNF - increased plasma TNF - and IL-6 , elevated body temperature , and blunted the GLP-1-induced suppression of EGP during high-dose GLP-1 infusion ( all P < .05 , TNF - vs saline ) .
RESULTS	However , TNF - infusion lowered plasma GLP-1 during high-dose GLP-1 infusion ( P < .001 ) .
CONCLUSIONS	TNF - induces systemic inflammation and reduces plasma GLP-1 , thereby reducing the suppression of EGP during GLP-1 infusion .
CONCLUSIONS	This may have clinical relevance if GLP-1 analog drugs are used for the treatment of hyperglycemia in critically ill patients .

###24526744
OBJECTIVE	To determine the efficacy and safety of azithromycin 1.5 % eye drops in a paediatric population with purulent bacterial conjunctivitis .
METHODS	This was a multicentre , international , randomised , investigator-masked study in 286 children with purulent discharge and bulbar conjunctival injection .
METHODS	Patients received either azithromycin 1.5 % eye drops ( twice daily for 3days ) or tobramycin 0.3 % eye drops ( every 2h for 2days , then four times daily for 5days ) .
METHODS	Clinical signs were evaluated on day ( D ) 0 , 3 and 7 , and cultures on D0 and D7 .
METHODS	The primary variable was the clinical cure ( absence of bulbar conjunctival injection and discharge ) on D3 in the worse eye for patients with positive cultures on D0 .
RESULTS	286 patients ( mean age 3.2 years ; range 1day-17years ) were included ; 203 had positive cultures on D0 .
RESULTS	Azithromycin was superior to tobramycin in clinical cure rate on D3 ( 47.1 % vs 28.7 % , p = 0.013 ) and was non-inferior to tobramycin on D7 ( 89.2 % vs 78.2 % , respectively ) .
RESULTS	Azithromycin treatment eradicated causative pathogens , including resistant species , with a similar resolution rate to tobramycin ( 89.8 % vs 87.2 % , respectively ) .
RESULTS	These results were confirmed in a subgroup of patients younger than 24months old .
CONCLUSIONS	Azithromycin 1.5 % eye drops provided a more rapid clinical cure than tobramycin 0.3 % eye drops in the treatment of purulent bacterial conjunctivitis in children , with a more convenient twice-a-day dosing regimen .

###25003802
OBJECTIVE	Mothers and children living in adverse contexts are at risk of premature death .
OBJECTIVE	To determine the effect of prenatal and infant/toddler nurse home visiting on maternal and child mortality during a 2-decade period ( 1990-2011 ) .
METHODS	A randomized clinical trial was designed originally to assess the home visiting program 's effect on pregnancy outcomes and maternal and child health through child age 2 years .
METHODS	The study was conducted in a public system of obstetric and pediatric care in Memphis , Tennessee .
METHODS	Participants included primarily African American women and their first live-born children living in highly disadvantaged urban neighborhoods , who were assigned to 1 of 4 treatment groups : treatment 1 ( transportation for prenatal care [ n = 166 ] ) , treatment 2 ( transportation plus developmental screening for infants and toddlers [ n = 514 ] ) , treatment 3 ( transportation plus prenatal/postpartum home visiting [ n = 230 ] ) , and treatment 4 ( transportation , screening , and prenatal , postpartum , and infant/toddler home visiting [ n = 228 ] ) .
METHODS	Treatments 1 and 3 were included originally to increase statistical power for testing pregnancy outcomes .
METHODS	For determining mortality , background information was available for all 1138 mothers assigned to all 4 treatments and all but 2 live-born children in treatments 2 and 4 ( n = 704 ) .
METHODS	Inclusion of children in treatments 1 and 3 was not possible because background information was missing on too many children .
METHODS	Nurses sought to improve the outcomes of pregnancy , children 's health and development , and mothers ' health and life-course with home visits beginning during pregnancy and continuing through child age 2 years .
METHODS	All-cause mortality in mothers and preventable-cause mortality in children ( sudden infant death syndrome , unintentional injury , and homicide ) derived from the National Death Index .
RESULTS	The mean ( SE ) 21-year maternal all-cause mortality rate was 3.7 % ( 0.74 % ) in the combined control group ( treatments 1 and 2 ) , 0.4 % ( 0.43 % ) in treatment 3 , and 2.2 % ( 0.97 % ) in treatment 4 .
RESULTS	The survival contrast of treatments 1 and 2 combined with treatment 3 was significant ( P = .007 ) ; the contrast of treatments 1 and 2 combined with treatment 4 was not significant ( P = .19 ) , and the contrast of treatments 1 and 2 combined with treatments 3 and 4 combined was significant ( post hoc P = .008 ) .
RESULTS	At child age 20 years , the preventable-cause child mortality rate was 1.6 % ( 0.57 % ) in treatment 2 and 0.0 % ( SE not calculable ) in treatment 4 ; the survival contrast was significant ( P = .04 ) .
CONCLUSIONS	Prenatal and infant/toddler home visitation by nurses is a promising means of reducing all-cause mortality among mothers and preventable-cause mortality in their first-born children living in highly disadvantaged settings .
BACKGROUND	clinicaltrials.gov Identifier : NCT00708695 .

###24918911
BACKGROUND	Radial artery ( RA ) was the second arterial graft introduced in clinical practice for myocardial revascularization .
BACKGROUND	The skeletonization technique of the left internal thoracic artery ( LITA ) may actually change the graft 's flow capacity with potential advantages .
BACKGROUND	This leads to the assumption that the behavior of the RA , as a coronary graft , is similar to that of the LITA , when skeletonized .
OBJECTIVE	This study evaluated ` free ' aortic-coronary radial artery ( RA ) grafts , whether skeletonized or with adjacent tissues .
METHODS	A prospective randomized study comparing 40 patients distributed into two groups was conducted .
METHODS	In group I , we used skeletonized radial arteries ( 20 patients ) , and in group II , we used radial arteries with adjacent tissues ( 20 patients ) .
METHODS	After the surgical procedure , patients underwent flow velocity measurements .
RESULTS	The main surgical variables were : RA internal diameter , RA length , and free blood flow in the radial artery .
RESULTS	The mean RA graft diameters as calculated using quantitative angiography in the immediate postoperative period were similar , as well as the flow velocity measurement variables .
RESULTS	On the other hand , coronary cineangiography showed the presence of occlusion in one RA graft and stenosis in five RA grafts in GII , while GI presented stenosis in only one RA graft ( p = 0.045 ) .
CONCLUSIONS	These results show that the morphological and pathological features , as well as the hemodynamic performance of the free radial artery grafts , whether prepared in a skeletonized manner or with adjacent tissues , are similar .
CONCLUSIONS	However , a larger number of non-obstructive lesions may be observed when RA is prepared with adjacent tissues .

###25599385
BACKGROUND	Skeletal muscle from sedentary older adults exhibits reduced mitochondrial abundance and oxidative capacity .
OBJECTIVE	The primary objective was to determine whether 8 weeks of combined training ( CT ) has a more robust effect than endurance training ( ET ) or resistance training ( RT ) on mitochondrial physiology in healthy young ( 18-30 years ) and older ( 65 years ) adults .
METHODS	Thirty-four young and 31 older adults were randomly assigned to 8 weeks of ET , RT , and control/CT .
METHODS	Control subjects completed 8 weeks of no exercise ( control ) followed by 8 weeks of CT. .
METHODS	Body composition , skeletal muscle strength , and peak oxygen uptake were measured before and after the intervention .
METHODS	Vastus lateralis muscle biopsy samples were obtained before and 48 hours after the intervention .
METHODS	Mitochondrial physiology was evaluated by high-resolution respirometry and expression of mitochondrial proteins and transcription factors by quantitative PCR and immunoblotting .
RESULTS	ET and CT significantly increased oxidative capacity and expression of mitochondrial proteins and transcription factors .
RESULTS	All training modalities improved body composition , cardiorespiratory fitness , and skeletal muscle strength .
RESULTS	CT induced the most robust improvements in mitochondria-related outcomes and physical characteristics despite lower training volumes for the ET and RT components .
RESULTS	Importantly , most of the adaptations to training occurred independent of age .
CONCLUSIONS	Collectively , these results demonstrate that both ET and CT increase muscle mitochondrial abundance and capacity although CT induced the most robust improvements in the outcomes measured .
CONCLUSIONS	In conclusion , CT provides a robust exercise regimen to improve muscle mitochondrial outcomes and physical characteristics independent of age .

###25607833
OBJECTIVE	The efficacy of posttraumatic stress disorder ( PTSD ) treatments in psychosis has not been examined in a randomized clinical trial to our knowledge .
OBJECTIVE	Psychosis is an exclusion criterion in most PTSD trials .
OBJECTIVE	To examine the efficacy and safety of prolonged exposure ( PE ) therapy and eye movement desensitization and reprocessing ( EMDR ) therapy in patients with psychotic disorders and comorbid PTSD .
METHODS	A single-blind randomized clinical trial with 3 arms ( N = 155 ) , including PE therapy , EMDR therapy , and waiting list ( WL ) of 13 outpatient mental health services among patients with a lifetime psychotic disorder and current chronic PTSD .
METHODS	Baseline , posttreatment , and 6-month follow-up assessments were made .
METHODS	Participants were randomized to receive 8 weekly 90-minute sessions of PE ( n = 53 ) , EMDR ( n = 55 ) , or WL ( n = 47 ) .
METHODS	Standard protocols were used , and treatment was not preceded by stabilizing psychotherapeutic interventions .
METHODS	Clinician-rated severity of PTSD symptoms , PTSD diagnosis , and full remission ( on the Clinician-Administered PTSD Scale ) were primary outcomes .
METHODS	Self-reported PTSD symptoms and posttraumatic cognitions were secondary outcomes .
RESULTS	Data were analyzed as intent to treat with linear mixed models and generalized estimating equations .
RESULTS	Participants in the PE and EMDR conditions showed a greater reduction of PTSD symptoms than those in the WL condition .
RESULTS	Between-group effect sizes were 0.78 ( P < .001 ) in PE and 0.65 ( P = .001 ) in EMDR .
RESULTS	Participants in the PE condition ( 56.6 % ; odds ratio [ OR ] , 3.41 ; P = .006 ) or the EMDR condition ( 60.0 % ; OR , 3.92 ; P < .001 ) were significantly more likely to achieve loss of diagnosis during treatment than those in the WL condition ( 27.7 % ) .
RESULTS	Participants in the PE condition ( 28.3 % ; OR , 5.79 ; P = .01 ) , but not those in the EMDR condition ( 16.4 % ; OR , 2.87 ; P = .10 ) , were more likely to gain full remission than those in the WL condition ( 6.4 % ) .
RESULTS	Treatment effects were maintained at the 6-month follow-up in PE and EMDR .
RESULTS	Similar results were obtained regarding secondary outcomes .
RESULTS	There were no differences in severe adverse events between conditions ( 2 in PE , 1 in EMDR , and 4 in WL ) .
RESULTS	The PE therapy and EMDR therapy showed no difference in any of the outcomes and no difference in participant dropout ( 24.5 % in PE and 20.0 % in EMDR , P = .57 ) .
CONCLUSIONS	Standard PE and EMDR protocols are effective , safe , and feasible in patients with PTSD and severe psychotic disorders , including current symptoms .
CONCLUSIONS	A priori exclusion of individuals with psychosis from evidence-based PTSD treatments may not be justifiable .
BACKGROUND	isrctn.com Identifier : ISRCTN79584912 .

###25406690
BACKGROUND	Until recently , non-specific low back pain ( NSLBP ) in adolescents was considered a rare phenomenon unlike in adults .
BACKGROUND	The last two decades has shown an increasing amount of research highlighting the prevalence in this age group .
BACKGROUND	Recent studies estimate lifetime prevalence at 7 % -80 % , point prevalence at 10 % -15 % , and prevalence of recurrent NSLBP at 13 % -36 % .
BACKGROUND	In Zimbabwe , there is dearth of literature on the magnitude of the problem in adolescents .
BACKGROUND	Therefore , the aims of the study were to determine the prevalence ( lifetime , point , recurrent ) and the nature of recurrent NSLBP reported by adolescents in secondary schools .
METHODS	A cross-sectional study was conducted using a questionnaire .
METHODS	A cluster sample of 544 adolescents ( age 13-19 years ) randomly derived from government schools participated in the study .
METHODS	Lifetime prevalence , point prevalence and prevalence of recurrent NSLBP were presented as percentages of the total population .
METHODS	Exact 95 % confidence intervals were given .
METHODS	Chi-square test was used to evaluate the effect of gender and age on prevalence .
RESULTS	The students ' response rate was 97.8 % .
RESULTS	The lifetime prevalence was 42.9 % [ 95 % confidence interval = 40.8-44 .6 ] with no significant difference between sexes [ 2 ( 1 ) = 0.006 , p = 0.94 ] .
RESULTS	However , NSLBP peaked earlier in female students ( 13.9 years ) than in male students ( 15 years ) [ t ( 226 ) = 4.21 , p < 0.001 ] .
RESULTS	About 10 % of the adolescents reported having an episode of NSLBP on the day of the survey .
RESULTS	However , female students ( 14.2 % ) were more affected on the day [ 2 ( 1 ) = 11.2 , p < 0.001 ] .
RESULTS	Twenty-nine percent of the adolescents experienced recurrent NSLBP with 78 % experiencing at least three episodes in the last 12 months .
RESULTS	On average , recurrent NSLBP reported was mild in intensity ( 4.8 1.9 ) on the visual analogue scale ( VAS ) and short in duration .
RESULTS	Recurrent NSLBP was associated with sciatica in 20.9 % of adolescents .
CONCLUSIONS	NSLBP is a common occurrence among Zimbabwean adolescents in secondary schools .
CONCLUSIONS	It increases with chronological age and is recurrent in the minority of adolescents .
CONCLUSIONS	Although much of the symptomatology may be considered benign , the existence of recurrent NSLBP in adolescents before their work-life begins should be a concern to health professionals , teachers and parents .

###24656240
BACKGROUND	We evaluated the efficacy of low-molecular-weight heparin ( LMWH ) relative to aspirin in preventing early neurologic deterioration ( END ) , venous thromboembolism ( VTE ) , and outcomes at 6months .
METHODS	Patients were randomly assigned to receive either subcutaneous enoxaparin 4000 anti-factor Xa IU/0 .4 mL twice daily or oral aspirin 200mg daily for 10days .
METHODS	After day 10 , all subjects received aspirin 100mg once daily for 6months .
METHODS	We assessed whether LMWH was superior to aspirin in preventing END and VTE within the first 10days after index stroke and evaluated 6-month outcomes .
RESULTS	Of the total 1368 patients , 7.89 % suffered from END , and 2.85 % suffered from deep-vein thrombosis during the first 10days , with a significance difference between the LMWH group and aspirin group ( 3.95 % , 1.46 % versus 11.82 % , 4.23 % , respectively ) .
RESULTS	At 6months , there was a significant difference in the frequency of good outcomes among patients over the median age of 70years ( LMWH 63.8 % versus aspirin 44.6 % ) .
RESULTS	The benefit of LMWH was also significant in patients with symptomatic stenosis of the posterior circulation and basilar artery ( 75.2 % and 82 % for LMWH versus 40.5 % and 48 % for aspirin , respectively ) .
CONCLUSIONS	For patients with acute ischemic stroke , treatment with LMWH within 48hours of stroke until 10days later may reduce END and deep-vein thrombosis during the first 10days .
CONCLUSIONS	LMWH appears to have advantages over aspirin in certain subgroups , such as elderly patients and patients with posterior circulation and basilar artery stenosis .

###25647122
OBJECTIVE	Using simulation-based mastery learning , residents can be trained to achieve a predefined performance standard in resuscitation .
OBJECTIVE	After mastery is achieved , performance degradation occurs over time .
OBJECTIVE	Prior investigations have shown performance retention of 12-14 months following intensive simulation-based mastery learning sessions .
OBJECTIVE	We sought to investigate the duration of mastery-level resuscitation performance retention after a single 1 - to 2-hour simulation-based mastery learning session .
METHODS	Randomized , prospective trial .
METHODS	Medical simulation laboratory .
METHODS	Convenience sample of 42 pediatric residents .
METHODS	Baseline resuscitation performance was determined on four standardized simulation scenarios .
METHODS	After determination of baseline performance , each resident repeated each scenario , as needed , until mastery-level performance was achieved .
METHODS	Residents were then randomized and retested 2 , 4 , or 6 months later .
METHODS	Statistical analysis on scores at baseline and retesting were used to determine performances changes from baseline and performance retention over time .
RESULTS	Forty-two residents participated in the study ( 12 in 2 mo group , 14 in 4 mo group , and 16 in 6 mo group ) .
RESULTS	At baseline , postgraduate year-3 residents performed better than postgraduate year-1 residents ( p = 0.003 ) .
RESULTS	Overall performance on each of the four scenarios improved at retesting .
RESULTS	The percent of residents maintaining mastery-level performance showed a significant linear decline ( p = 0.039 ) , with a drop at each retesting interval ; 92 % retained mastery at 2 months , 71 % at 4 months , and 56 % at 6 months .
RESULTS	There was no difference in retention between postgraduate year-1 , postgraduate year-2 , and postgraduate year-3 residents ( p = 0.14 ) .
CONCLUSIONS	Residents displayed significant improvements in resuscitation performance after a single simulation-based mastery learning session , but performance declined over time , with less than 60 % retaining mastery-level performance at 6 months .
CONCLUSIONS	Our results suggest that relatively frequent refresher training is needed after a single simulation-based mastery learning session .
CONCLUSIONS	Additional research is needed to determine the duration of performance retention following any specific simulation-based mastery learning intervention .

###25123755
OBJECTIVE	Diabetic retinopathy ( DR ) is associated with a higher risk of renal and cardiovascular events .
OBJECTIVE	We sought to compare the risk for renal versus cardiovascular ( CV ) outcomes , stratified by retinopathy severity .
METHODS	ACCORD was a randomized trial of people with type 2 diabetes , at high-risk for CV disease .
METHODS	A subgroup ( n = 3,369 from 71 clinics ) had stereoscopic fundus photographs graded centrally .
METHODS	Participants were stratified at baseline to moderate/severe DR or no/mild DR and were monitored for renal and CV outcomes at follow-up visits over 4 years .
METHODS	The composite renal outcome was composed of serum creatinine doubling , macroalbuminuria , or end-stage renal disease .
METHODS	The composite CV outcome was the ACCORD trial primary outcome .
METHODS	Competing risk techniques were used to estimate the relative risk ( RR ) of renal versus CV composite outcomes within each DR stratum .
RESULTS	The hazards ratio for doubling of serum creatinine and incident CV event in the moderate/severe DR versus no/mild DR strata were : 2.31 ( 95 % CI : 1.25-4 .26 ) and 1.98 ( 95 % CI : 1.49-2 .62 ) , respectively .
RESULTS	The RR of the two composite outcomes was highly similar in the no/mild DR stratum ( adjusted RR at 4 years for CV versus renal events = 0.96 , 95 % CI : 0.72-1 .28 ) and the moderate/severe DR stratum ( adjusted RR = 0.92 , 95 % CI : 0.64-1 .31 ) .
CONCLUSIONS	Thus , in people with type 2 diabetes at high risk for cardiovascular disease , incident CV versus renal events was similar , irrespective of the severity of the DR. Further evaluation of the specificity of DR for microvascular versus macrovascular events in other populations is warranted .

###25307730
OBJECTIVE	We propose a new hybrid brain-computer interface ( BCI ) system that integrates two different EEG tasks : tactile selective attention ( TSA ) using a vibro-tactile stimulator on the left/right finger and motor imagery ( MI ) of left/right hand movement .
OBJECTIVE	Event-related desynchronization ( ERD ) from the MI task and steady-state somatosensory evoked potential ( SSSEP ) from the TSA task are retrieved and combined into two hybrid senses .
METHODS	One hybrid approach is to measure two tasks simultaneously ; the features of each task are combined for testing .
METHODS	Another hybrid approach is to measure two tasks consecutively ( TSA first and MI next ) using only MI features .
METHODS	For comparison with the hybrid approaches , the TSA and MI tasks are measured independently .
RESULTS	Using a total of 16 subject datasets , we analyzed the BCI classification performance for MI , TSA and two hybrid approaches in a comparative manner ; we found that the consecutive hybrid approach outperformed the others , yielding about a 10 % improvement in classification accuracy relative to MI alone .
RESULTS	It is understood that TSA may play a crucial role as a prestimulus in that it helps to generate earlier ERD prior to MI and thus sustains ERD longer and to a stronger degree ; this ERD may give more discriminative information than ERD in MI alone .
CONCLUSIONS	Overall , our proposed consecutive hybrid approach is very promising for the development of advanced BCI systems .

###25311998
BACKGROUND	Despite the extraordinary scale up of HIV prevention , care and treatment services in sub-Saharan Africa ( SSA ) over the past decade , the overall effectiveness of HIV programs has been significantly hindered by high levels of attrition across the HIV care continuum .
BACKGROUND	Data from `` real-life '' settings are needed on the effectiveness of an easy to deliver package of services that can improve overall performance of the HIV care continuum .
METHODS	We are conducting an implementation science study using a two-arm cluster site-randomized design to determine the effectiveness of a combination intervention strategy ( CIS ) using feasible , evidence-based , and practical interventions-including ( 1 ) point-of-care ( POC ) CD4 count testing , ( 2 ) accelerated antiretroviral therapy initiation for eligible individuals , and ( 3 ) SMS reminders for linkage to and retention in care-as compared to the standard of care ( SOC ) in Mozambique in improving linkage and retention among adults following HIV diagnosis .
METHODS	A pre-post intervention two-sample design is nested within the CIS arm to assess the incremental effectiveness of the CIS plus financial incentives ( CIS + FI ) compared to the CIS without FI on study outcomes .
METHODS	Randomization is done at the level of the study site , defined as a primary health facility .
METHODS	Five sites are included from the City of Maputo and five from Inhambane Province .
METHODS	Target enrollment is a total of 2,250 adults : 750 in the SOC arm , 750 in the CIS cohort of the intervention arm and 750 in the CIS + FI cohort of the intervention arm ( average of 150 participants per site ) .
METHODS	Participants are followed for 12 months from time of HIV testing to ascertain a combined endpoint of linkage to care within 1 month after testing and retention in care 12 months from HIV test .
METHODS	Cost-effectiveness analyses of CIS compared to SOC and CIS + FI compared to CIS will also be conducted .
CONCLUSIONS	Study findings will provide evidence on the effectiveness of a CIS and the incremental effectiveness of a CIS + FI in a `` real-life '' service delivery system in a SSA country severely impacted by HIV .
BACKGROUND	Clinicaltrials.gov , NCT01930084 .

###24642785
OBJECTIVE	High calcium intakes enhance fat loss under restricted energy intake .
OBJECTIVE	Mechanisms explaining this may involve reduced dietary fat absorption , enhanced lipid utilization and ( or ) reductions in appetite .
OBJECTIVE	This study aimed to assess the impact of 2 weeks of calcium supplementation on substrate utilization during exercise and appetite sensations at rest .
METHODS	Thirteen physically active males completed two 14-d supplemental periods , in a double-blind , randomized crossover design separated by a 4-week washout period .
METHODS	During supplementation , a test-drink was consumed daily containing 400 and 1400mg of calcium during control ( CON ) and high-calcium ( CAL ) periods , respectively .
METHODS	Cycling-based exercise tests were conducted before and after each supplemental period to determine substrate utilization rates and circulating metabolic markers ( non-esterified fatty acid , glycerol , glucose and lactate concentrations ) across a range of exercise intensities .
METHODS	Visual analog scales were completed in the fasting , rested state to determine subjective appetite sensations .
RESULTS	No significant differences between supplements were observed in lipid or carbohydrate utilization rates , nor in circulating metabolic markers ( both P > 0.05 ) .
RESULTS	Maximum rates of lipid utilization were 0.470.05 and 0.440.05 g/min for CON and CAL , respectively , prior to supplementation and 0.440.05 and 0.420.05 g/min , respectively , post-supplementation ( main effects of time , supplement and time x supplement interaction effect all P > 0.05 ) .
RESULTS	Furthermore , no significant differences were detected in any subjective appetite sensations ( all P > 0.05 ) .
CONCLUSIONS	Two weeks of calcium supplementation does not influence substrate utilization during exercise in physically active males .

###25448515
OBJECTIVE	The objective of the study was to evaluate the efficacy of 17 alpha-hydroxyprogesterone caproate ( 17OHP-C ) in prolonging gestation in patients with a short cervix and other risk factors for preterm delivery , such as previous preterm birth , cervical surgery , uterine anomalies , or prenatal diethylstilbestrol ( DES ) exposure .
METHODS	This open-label , multicenter , randomized controlled trial included asymptomatic singleton pregnancies from 20 ( +0 ) through 31 ( +6 ) weeks of gestation with a cervical length less than 25 mm and a history of preterm delivery or cervical surgery or uterine malformation or prenatal DES exposure .
METHODS	Randomization assigned them to receive ( or not ) 500 mg of intramuscular 17OHP-C weekly until 36 weeks .
METHODS	The primary outcome was time from randomization to delivery .
RESULTS	After enrolling 105 patients , an interim analysis demonstrated the lack of efficacy of 17OHP-C in prolonging pregnancy .
RESULTS	The study was discontinued because of futility .
RESULTS	The groups were similar for maternal age , body mass index , parity , gestational age at inclusion , history of uterine anomalies , DES syndrome , previous preterm delivery or midtrimester abortion , and cervical length at randomization .
RESULTS	The enrollment-to-delivery interval did not differ between patients allocated to 17OHP-C ( n = 51 ) and those allocated to the control group ( n = 54 ) ( median [ interquartile range ] time to delivery : 77 [ 54-103 ] and 74 [ 52-99 ] days , respectively ) .
RESULTS	The rate of preterm delivery less than 37 ( 45 % vs 44 % , P > .99 ) , less than 34 ( 24 % vs 30 % , P = .51 ) , or less than 32 ( 14 % vs 20 % , P = .44 ) weeks was similar in patients allocated to 17OHP-C and those in the control group .
CONCLUSIONS	17OHP-C did not prolong pregnancy in women with singleton gestations , a sonographic short cervix , and other risk factors of preterm delivery ( prior history , uterine malformations , cervical surgery , or prenatal DES exposure ) .

###24879304
BACKGROUND	The objectives of this trial were to investigate short-term changes in product usage , tobacco-related biomarkers of exposure , and subjective effects in smokers who switched to dissolvable tobacco ( Camel Orbs ) use .
METHODS	Participants were randomized into 1 of 4 groups ( continued smoking , switched to consuming Orbs , switched to dual use of cigarettes and Orbs , and tobacco abstinent ) and confined for 6 days with dietary restrictions .
METHODS	Most measurements were at baseline and days 1 , 3 , and 5 of intervention .
METHODS	Mouth-level tar and nicotine exposures were estimated by filter tip analysis .
METHODS	Twenty biomarkers were quantified in 24-hr urine ; 4 were quantified in blood/plasma ( carboxyhemoglobin , nicotine , cotinine , and thiocyanate ) .
METHODS	Ratings for nicotine dependence and withdrawal symptoms were scored .
RESULTS	After 5 days , substantial and statistically significant reductions ( ~ 30 % -90 % ) in all biomarkers were observed in the Orbs and abstinent groups compared to baseline .
RESULTS	Numerous smaller reductions ( ~ 7 % -30 % ) were also noted in the continued smoking and dual-use groups ( generally similar in magnitude for both groups ) .
RESULTS	Subjective questionnaire findings indicated greater withdrawal discomfort levels throughout the intervention period for the nonsmoking groups .
RESULTS	For subjects that continued smoking , clinical confinement conditions did not significantly alter product use behavior and toxicant exposure profile compared to baseline .
CONCLUSIONS	Substantial reductions in toxicant exposure occurred for participants that did not smoke .
CONCLUSIONS	Cigarette smokers that switched to Orbs use showed reductions in all biomarkers , similar to abstinent group .
CONCLUSIONS	Changes in toxicant exposure for the dual-use group were similar to the continued-smoking group , consistent with minimal changes observed in that group 's product use behavior ( small reduction in cigarettes per day and small increase in Orbs use ) .

###25613308
OBJECTIVE	Our aim was to identify whether particular subgroups of patients had an unacceptably high risk of symptomatic intracranial hemorrhage or low chance of benefit when treated with alteplase ( recombinant tissue-type plasminogen activator ) .
METHODS	Third International Stroke Trial was an international randomized trial of the intravenous ( IV ) recombinant plasminogen activator alteplase ( 0.9 mg/kg ) versus control in 3035 ( 1515 versus 1520 ) patients .
METHODS	We analyzed the effect of recombinant tissue-type plasminogen activator on 6-month functional outcome , early death , and symptomatic intracranial hemorrhage ( both 7 days ) .
METHODS	We tested for any differences in treatment effect between subgroups by a test of interaction .
METHODS	Our 13 protocol prespecified subgroups were time to randomization , age , sex , stroke subtype , atrial fibrillation , early ischemic change ( clinician and expert panel ) , prior antiplatelet use , stroke severity , diastolic and systolic blood pressure at randomization , center 's thrombolysis experience , and trial phase .
METHODS	Analyses were adjusted for key baseline prognostic factors .
RESULTS	There were no significant interactions in the subgroups analyzed that were consistent across all 3 outcomes .
RESULTS	Treatment with recombinant tissue-type plasminogen activator increased the odds of symptomatic intracranial hemorrhage by a greater amount in patients taking prior antiplatelets than those who were not ( P = 0.019 for test of interaction ) , but had no clear detrimental effect on functional outcome at 6 months in this group ( P = 0.781 for test of interaction ) .
CONCLUSIONS	Among the types of patient in the Third International Stroke Trial , this secondary analysis did not identify any subgroups for whom treatment should be avoided .
CONCLUSIONS	Given the limitations of the analysis , we found no clear evidence to avoid treatment in patients with prior ischemic stroke , diabetes mellitus , or hypertension .
BACKGROUND	http://www.controlled-trials.com .
BACKGROUND	Unique identifier : ISRCTN25765518 .
BACKGROUND	http://www.controlled-trials.com/ISRCTN25765518 .

###24983706
OBJECTIVE	Exercise training induces several beneficial effects in patients with chronic heart failure ( CHF ) .
OBJECTIVE	This study investigated the effects of high-intensity aerobic interval training ( AIT ) compared with combined AIT and strength training ( COM ) on early ventilatory and metabolic recovery pattern after symptom-limited cardiopulmonary exercise testing ( CPET ) in CHF patients .
METHODS	Stable CHF patients ( N = 42 ; 54 10 years [ mean SD ] , 35 males ) participated in an exercise training program for 12 weeks , 3 times per week .
METHODS	Participants were randomly assigned to either AIT ( n = 20 ) or COM group ( n = 22 ) .
METHODS	Cardiopulmonary exercise testing was performed before and after completion of the program .
METHODS	Primary measurements included absolute and percentage difference of oxygen uptake , carbon dioxide output , minute ventilation ( ( Equation is included in full-text article . )
METHODS	E ) , tidal volume ( VT ) , respiratory rate , and the first-degree slope of oxygen uptake ( ( Equation is included in full-text article . )
METHODS	O2/t slope ) and carbon dioxide output ( ( Equation is included in full-text article . )
METHODS	CO2/t slope ) during the first minute of recovery after maximal exercise .
RESULTS	The COM group had a greater improvement in the absolute and the percentage difference of ( Equation is included in full-text article . )
RESULTS	E ( P = .03 and P = .04 , respectively ) and respiratory rate ( P = .02 and P = .01 , respectively ) during the first minute of recovery period after exercise compared with the AIT group alone .
RESULTS	No significant changes were noted for VT measurements .
RESULTS	A significant increase in ( Equation is included in full-text article . )
RESULTS	CO2/t slope was observed in COM compared with the AIT group ( P = .01 ) .
RESULTS	There was a trend for a greater increase in ( Equation is included in full-text article . )
RESULTS	O2/t slope in the COM group ( P = .07 ) .
CONCLUSIONS	The addition of strength training to AIT induces significant beneficial effects in terms of ventilatory and metabolic recovery kinetics than AIT alone in CHF patients , possibly indicating greater ventilatory efficiency and metabolic improvement .

###24957557
BACKGROUND	The DBCG-IMN is a nationwide population-based cohort study on the effect of internal mammary node radiotherapy ( IMN-RT ) in patients with node positive early breast cancer .
BACKGROUND	Due to the risk of RT-induced heart disease , only patients with right-sided breast cancer received IMN-RT , whereas patients with left-sided breast cancer did not .
BACKGROUND	At seven-year median follow-up , a 3 % gain in overall survival with IMN-RT has been reported .
BACKGROUND	This study estimates IMN doses and doses to organs at risk ( OAR ) in patients from the DBCG-IMN .
BACKGROUND	Numbers needed to harm ( NNH ) if patients with left-sided breast cancer had received IMN-RT are compared to the number needed to treat ( NNT ) .
METHODS	Ten percent of CT-guided treatment plans from the DBCG-IMN patients were selected randomly .
METHODS	IMNs and OAR were contoured in 68 planning CT scans .
METHODS	Dose distributions were re-calculated .
METHODS	IMNs and OAR dose estimates were compared in right-sided versus left-sided breast cancer patients .
METHODS	In six left-sided patients , IMN-RT was simulated , and OAR doses were compared to those in the original plan .
METHODS	The NNH resulting from the change in mean heart dose ( MHD ) was calculated using a published model for risk of RT-related ischemic heart death .
RESULTS	In original plans , the absolute difference between right - and left-sided V90 % to the IMNs was 38.0 % [ 95 % confidence interval ( 5.5 % ; 70.5 % ) , p < 0.05 ] .
RESULTS	Heart doses were higher in left-sided plans .
RESULTS	With IMN-RT simulation without regard to OAR constraints , MHD increased 4.8 Gy ( 0.9 Gy ; 8.7 Gy ) , p < 0.05 .
RESULTS	Resulting NNHs from ischemic heart death were consistently larger than the NNT with IMN-RT .
CONCLUSIONS	Refraining from IMN-RT on the left side may have spared some ischemic heart deaths .
CONCLUSIONS	Assuming left-sided patients benefit as much from IMN-RT as right-sided patients , the benefits from IMN-RT outweigh the costs in terms of ischemic heart death .

###25135997
OBJECTIVE	To investigate the impact and mechanisms of vitamin D deficiency ( VDD ) on the outcome of elderly patients with diffuse large B-cell lymphoma ( DLBCL ) .
METHODS	Three hundred fifty-nine pretreatment 25-hydroxyvitamin D3 ( 25 [ OH ] D3 ) serum levels from the RICOVER-60 study ( Six Versus Eight Cycles of Biweekly CHOP-14 With or Without Rituximab in Elderly Patients With Aggressive CD20 + B-Cell Lymphomas ) and 63 from the RICOVER-noRTh study ( an amendment to the RICOVER-60 study in which patients received six cycles of cyclophosphamide , doxorubicin , vincristine , and prednisone administered at an interval of 2 weeks plus two cycles of rituximab [ R-CHOP-14 ] , but without radiotherapy ) were determined by chemoluminescent immunoassay .
METHODS	Rituximab-mediated cellular cytotoxicity ( RMCC ) was assessed by lactate dehydrogenase release assay of CD20 + Daudi cells .
RESULTS	RICOVER-60 patients with VDD ( 8 ng/mL ) and vitamin D levels more than 8 ng/mL treated with rituximab had 3-year event-free survival ( EFS ) of 59 % and 79 % and 3-year overall survival ( OS ) of 70 % and 82 % , respectively .
RESULTS	These differences were significant in a multivariable analysis adjusting for International Prognostic Index risk factors with a hazard ratio ( HR ) of 2.1 ( P = .008 ) for EFS and 1.9 ( P = .040 ) for OS .
RESULTS	EFS was not significantly different in patients with vitamin D levels 8 or more than 8 ng/mL ( HR , 1.2 ; P = .388 ) treated without rituximab .
RESULTS	This was confirmed in an independent validation set of 63 RICOVER-noRTh patients .
RESULTS	RMCC increased significantly ( P < .001 ) in seven of seven individuals with VDD after substitution and normalization of their vitamin D levels .
CONCLUSIONS	VDD is a risk factor for elderly patients with DLBCL treated with R-CHOP .
CONCLUSIONS	That VDD impairs RMCC and substitution improves RMCC strongly suggests that vitamin D substitution enhances rituximab efficacy , which must be confirmed in appropriately designed prospective trials addressing VDD and substitution not only in DLBCL , but also in malignancies treated with other antibodies , of which the major mechanism of action is antibody-dependent cellular cytotoxicity ( eg , trastuzumab in breast cancer and cetuximab in colorectal cancer ) .

###26442397
BACKGROUND	Several additives have been suggested to enhance analgesic effect of local anesthetic agents to decrease the adverse effects of them and increase the degree of satisfaction .
BACKGROUND	We designed this randomized double-blind controlled study to evaluate the analgesic efficacy of the neostigmine added to bupivacaine using spinal anesthesia in patients undergoing lower limb orthopedic surgery .
METHODS	Sixty patients 18-80 yr old American Society of Anesthesiologists ( ASA ) physical status I or II , scheduled for femur surgery under spinal anesthesia , were recruited in a prospective , double-blinded , randomized way .
METHODS	The patients were randomly allocated to one of two groups of 30 each .
METHODS	The neostigmine group ( group N ) received bupivacaine 20 mg combined with 25 g neostigmine , and the placebo group ( group C ) received bupivacaine 20 mg combined with 0.5 ml distilled water ( intrathecally ) 5 minutes prior to surgery .
METHODS	The time to the first analgesic request , analgesic requirement in the first 12 hours after surgery , the duration of sensory and motor blockade , the incidence of adverse effects such as nausea , vomiting , hypotension , ephedrine requirements , bradycardia , and hypoxemia were recorded .
RESULTS	Patients receiving neostigmine had a significantly prolonged duration of motor block ( C95 % CI 30.27 to 87.65 ; P < 0.001 ) and sensory block ( C95 % CI 101.04 to 224.64 ; P < 0.001 ) compared to the control group .
RESULTS	The difference of the mean time to the first analgesic request was also significantly longer in neostigmine group ( C95 % CI 83.139 to 208.526 ; P < 0.001 ) .
RESULTS	The total analgesic consumption during the first 12 hours after surgery was devoid of any significant difference between groups N and C ( p = 0.41 ) .
RESULTS	The two groups were not significantly different in terms of intraoperative and postoperative side effects .
CONCLUSIONS	Intrathecal neostigmine 25 g with bupivacaine caused a prolonged time to the first analgesic request and its use was not associated with any side effects .

###24401239
OBJECTIVE	To analyze pomegranate extract ( POMx ) effects on serum and on human HMDM atherogenicity in simvastatin - treated hypercholesterolemic patients .
RESULTS	Patients were randomly assigned to receive either simvastatin ( 20 mg/day ) + vegan placebo pill ( n = 11 ) , or simvastatin ( 20 mg/day ) + POMx pill ( 1g/day , n = 12 ) .
RESULTS	Fasting blood samples were collected at baseline and after 1 and 2 months of therapy .
RESULTS	HMDM were collected from 3 patients in each group at baseline and after 2 months of therapy , as well as from 3 healthy subjects .
RESULTS	After 2 months of therapy , serum LDL-cholesterol levels significantly decreased , by 23 % , in the simvastatin + placebo group , and by 26 % in the simvastatin + POMx group .
RESULTS	Simvastatin + POMx therapy increased serum thiols concentration by 6 % .
RESULTS	Patients ' HMDM reactive oxygen species ( ROS ) levels were significantly increased , by 69 % , vs. healthy subjects HMDM .
RESULTS	After 2 months of therapy , HMDM ROS levels decreased by 18 % in the simvastatin + placebo group , whereas in the simvastatin + POMx group it decreased by up to 30 % .
RESULTS	A novel finding was the triglycerides levels in the patients ' HMDM at baseline which were significantly higher , by 71 % , vs. healthy subjects HMDM .
RESULTS	The simvastatin + POMx , but not the simvastatin + placebo therapy , significantly reduced macrophage triglycerides content by 48 % , vs. baseline levels .
RESULTS	In addition , whereas the simvastatin + placebo therapy significantly decreased the patients ' HMDM cholesterol biosynthesis rate by 33 % , the simvastatin + POMx therapy further decreased it , by 44 % .
CONCLUSIONS	The addition of POMx to simvastatin therapy in hypercholesterolemic patients improved oxidative stress and lipid status in the patient 's serum and in their HMDM .
CONCLUSIONS	These anti-atherogenic effects could reduce the risk for atherosclerosis development .

###25517809
OBJECTIVE	To estimate the incremental cost-effectiveness of tuberculosis ( TB ) screening and isoniazid preventive therapy ( IPT ) among human immunodeficiency virus ( HIV ) infected adults in Rio de Janeiro , Brazil .
METHODS	We used decision analysis , populated by data from a cluster-randomized trial , to project the costs ( in 2010 USD ) and effectiveness ( in disability-adjusted life years [ DALYs ] averted ) of training health care workers to implement the tuberculin skin test ( TST ) , followed by IPT for TST-positive patients with no evidence of active TB .
METHODS	This intervention was compared to a baseline of usual care .
METHODS	We used time horizons of 1 year for the intervention and 20 years for disease outcomes , with all future DALYs and medical costs discounted at 3 % per year .
RESULTS	Providing this intervention to 100 people would avert 1.14 discounted DALYs ( 1.57 undiscounted DALYs ) .
RESULTS	The median estimated incremental cost-effectiveness ratio was $ 2273 ( IQR $ 1779 - $ 3135 ) per DALY averted , less than Brazil 's 2010 per capita gross domestic product ( GDP ) of $ 11,700 .
RESULTS	Results were most sensitive to the cost of providing the training .
CONCLUSIONS	Training health care workers to screen HIV-infected adults with TST and provide IPT to those with latent tuberculous infection can be considered cost-effective relative to the Brazilian GDP per capita .

###24577097
BACKGROUND	The present study is an open-label extension ( OLE ) aimed at evaluating the effect of 100 mg/day of phosphatidylserine enriched with docosahexaenoic acid ( PS-DHA ) on cognitive performance in nondemented elderly individuals with memory complaints .
METHODS	From the participants who completed the core study , 122 continued with a 15-week OLE .
METHODS	Efficacy was assessed using a computerized tool and the Clinical Global Impression of Change ( CGI-C ) rating scale .
RESULTS	A significant improvement in sustained attention and memory recognition was observed in the PS-DHA nave group , while the PS-DHA continuers maintained their cognitive status .
RESULTS	Additionally , a significant improvement in CGI-C was observed in the nave group .
CONCLUSIONS	The results demonstrate that consumption of 100 mg/day of PS-DHA might be associated with improving or maintaining cognitive status in elderly subjects with memory complaints .

###24456787
OBJECTIVE	To evaluate the effects of terazosin and tolterodine on ureteral stent discomfort .
METHODS	Of 163 patients assessed for eligibility , 104 patients were randomly assigned to receive placebo , 2 mg of terazosin twice daily , 2 mg of tolterodine daily , or both terazosin plus tolterodine during the stenting period .
METHODS	Prior to stenting and at stent removal , the International Prostate Symptom Score ( IPSS ) , the IPSS quality of life ( QoL ) subscore and the Visual Analog Scale for Pain were determined .
METHODS	The patients also reported their analgesic use during the stenting period .
RESULTS	Ninety-four patients completed the study .
RESULTS	We noted significant decreases in the total IPSS scores ( p = 0.002 ) , irritative subscore ( p = 0.039 ) , QoL ( p = 0.001 ) , flank pain ( p = 0.013 ) , voiding pain ( p = 0.01 ) and amount of analgesics used ( p = 0.02 ) in the groups .
RESULTS	However , neither the obstructive subscore nor the suprapubic pain improved significantly ( p = 0.251 and p = 0.522 , respectively ) .
RESULTS	The patients receiving terazosin plus tolterodine experienced significant reductions in the total IPSS , irritative symptoms , QoL , flank pain , voiding pain and decreased analgesics use compared with those patients receiving placebo .
RESULTS	However , compared with placebo , terazosin monotherapy did not affect pain levels , and tolterodine monotherapy did not improve QoL , flank pain or analgesics use .
CONCLUSIONS	Terazosin plus tolterodine improves ureteral stent-related complications , including irritative symptoms , the amount of analgesics used , QoL , flank pain and voiding pain but does not decrease obstructive symptoms or suprapubic pain .
CONCLUSIONS	This trial was registered at www.clinicaltrials.gov as NCT01530243 .

###24629823
OBJECTIVE	To assess the effects of fentanyl administered before induction of anesthesia on movement and airway responses during desflurane anesthesia via the Laryngeal Mask Airway ( LMA ) .
METHODS	Randomized , double-blinded , controlled trial .
METHODS	Tertiary-care academic center .
METHODS	100 adult , ASA physical status 1 , 2 , and 3 patients undergoing ambulatory surgery .
METHODS	Patients were administered fentanyl 1 g/kg ( n = 51 ) or saline ( n = 49 ) 3 to 5 minutes before induction with propofol 2-2 .5 mg/kg intravenously ( IV ) , followed by LMA placement .
METHODS	Anesthesia was maintained with desflurane titrated to a bispectral index ( BIS ) of 50-60 and 50 % nitrous oxide in oxygen , and fentanyl 25 g boluses were titrated to respiratory rate .
METHODS	Apnea occurrence and duration of manual ventilation , as well as frequency and severity of movement , coughing , breath holding , and laryngospasm were recorded .
RESULTS	Two patients in each group were excluded from analysis .
RESULTS	The fentanyl pretreatment group had a higher frequency of apnea ( 94 % vs 64 % ; P = 0.0003 ) and longer duration of manual ventilation ( 3 [ interquartile range ( IQR ) , 1.5-5 ] min vs 1 [ 0-1 .5 ] min ; P < 0.0001 ) at induction .
RESULTS	In contrast , the fentanyl pretreatment group had a lower frequency of movements ( 16 % vs 51 % ;P = 0.0001 ) .
RESULTS	The rates of intraoperative breath holding ( 6.1 % vs 8.5 % ) and laryngospasm ( 2 % vs 4.3 % ) in the two groups were similar .
RESULTS	All subjects experiencing laryngospasm were smokers .
RESULTS	Adjusting for smoking status did not affect the differences noted in apnea , duration of manual ventilation , or movement between groups ; however , coughing occurrence was statistically higher in the placebo group ( P = 0.043 ) .
CONCLUSIONS	Preinduction fentanyl increased the frequency of apnea at induction and duration of manual ventilation , but reduced the frequency of movements .
CONCLUSIONS	In addition , it reduced intraoperative coughing in smokers .

###25399007
OBJECTIVE	Acute kidney injury , a common complication of surgery , is associated with poor outcomes and high health care costs .
OBJECTIVE	Some studies suggest aspirin or clonidine administered during the perioperative period reduces the risk of acute kidney injury ; however , these effects are uncertain and each intervention has the potential for harm .
OBJECTIVE	To determine whether aspirin compared with placebo , and clonidine compared with placebo , alters the risk of perioperative acute kidney injury .
METHODS	A 22 factorial randomized , blinded , clinical trial of 6905 patients undergoing noncardiac surgery from 88 centers in 22 countries with consecutive patients enrolled between January 2011 and December 2013 .
METHODS	Patients were assigned to take aspirin ( 200 mg ) or placebo 2 to 4 hours before surgery and then aspirin ( 100 mg ) or placebo daily up to 30 days after surgery , and were assigned to take oral clonidine ( 0.2 mg ) or placebo 2 to 4 hours before surgery , and then a transdermal clonidine patch ( which provided clonidine at 0.2 mg/d ) or placebo patch that remained until 72 hours after surgery .
METHODS	Acute kidney injury was primarily defined as an increase in serum creatinine concentration from the preoperative concentration by either an increase of 0.3 mg/dL or greater ( 26.5 mol/L ) within 48 hours of surgery or an increase of 50 % or greater within 7 days of surgery .
RESULTS	Aspirin ( n = 3443 ) vs placebo ( n = 3462 ) did not alter the risk of acute kidney injury ( 13.4 % vs 12.3 % , respectively ; adjusted relative risk , 1.10 ; 95 % CI , 0.96-1 .25 ) .
RESULTS	Clonidine ( n = 3453 ) vs placebo ( n = 3452 ) did not alter the risk of acute kidney injury ( 13.0 % vs 12.7 % , respectively ; adjusted relative risk , 1.03 ; 95 % CI , 0.90-1 .18 ) .
RESULTS	Aspirin increased the risk of major bleeding .
RESULTS	In a post hoc analysis , major bleeding was associated with a greater risk of subsequent acute kidney injury ( 23.3 % when bleeding was present vs 12.3 % when bleeding was absent ; adjusted hazard ratio , 2.20 ; 95 % CI , 1.72-2 .83 ) .
RESULTS	Similarly , clonidine increased the risk of clinically important hypotension .
RESULTS	In a post hoc analysis , clinically important hypotension was associated with a greater risk of subsequent acute kidney injury ( 14.3 % when hypotension was present vs 11.8 % when hypotension was absent ; adjusted hazard ratio , 1.34 ; 95 % CI , 1.14-1 .58 ) .
CONCLUSIONS	Among patients undergoing major noncardiac surgery , neither aspirin nor clonidine administered perioperatively reduced the risk of acute kidney injury .
BACKGROUND	clinicaltrials.gov Identifier : NCT01082874 .

###25149384
OBJECTIVE	To study the effect of Yinxieling decoction on PASI , TNF - and IL-8 in patients with psoriasis vulgaris .
METHODS	A total of 120 cases of psoriasis vulgaris were divided into 4 groups according to syndrome differentiation of TCM and randomized controlled method : wind heat syndrome group ( group A ) , blood stasis syndrome group ( group B ) , blood dryness syndrome group ( group C ) and control group ( group D ) ( n = 30 per group ) .
METHODS	Patients in observation groups were treated with Yinxieling decoction , while patients in control group were treated by placebo for 8 weeks .
METHODS	Levels of TNF - and IL-8 were determined before treatment , 4 and 8 weeks after treatment .
METHODS	psoriasis area and severity index score was also performed before and after treatment .
RESULTS	psoriasis area and severity index score and serum level of TNF - , IL-8 were significantly decreased in all groups .
RESULTS	The decrease in three observation groups was more significant ( P < 0.05 or P < 0.01 ) , and the decrease in wind heat syndrome group was the most significant ( P < 0.01 ) .
RESULTS	psoriasis area and severity index was positively correlated with TNF - and IL-8 , respectively ( P < 0.05 ) .
CONCLUSIONS	Yinxieling decoction has therapeutical effect on psoriasis vulgaris via regulating TNF - and IL-8 .

###25707331
OBJECTIVE	To identify baseline characteristics of women with unexplained infertility to determine whether treatment with an aromatase inhibitor will result in a lower rate of multiple gestations than current standard ovulation induction medications .
METHODS	Randomized , prospective clinical trial .
METHODS	Multicenter university-based clinical practices .
METHODS	A total of 900 couples with unexplained infertility .
METHODS	Collection of baseline demographics , blood samples , and ultrasonographic assessments .
METHODS	Demographic , laboratory , imaging , and survey characteristics .
RESULTS	Demographic characteristics of women receiving clomiphene citrate ( CC ) , letrozole , or gonadotropins for ovarian stimulation were very consistent .
RESULTS	Their mean age was 32.2 4.4 years and infertility duration was 34.7 25.7 months , with 59 % primary infertility .
RESULTS	More than one-third of the women were current or past smokers .
RESULTS	The mean body mass index ( BMI ) was 27 and mean antimllerian hormone level was 2.6 ; only 11 women ( 1.3 % ) had antral follicle counts of < 5 .
RESULTS	Similar observations were identified for hormonal profiles , ultrasound characterization of the ovaries , semen parameters , and quality of life assessments in both male and female partners .
CONCLUSIONS	The cause of infertility in the couples recruited to this treatment trial is elusive , as the women were regularly ovulating and had evidence of good ovarian reserve both by basal FSH , antimllerian hormone levels , and antral follicle counts ; the male partners had normal semen parameters .
CONCLUSIONS	The three treatment groups have common baseline characteristics , thereby providing comparable patient populations for testing the hypothesis that use of letrozole for ovarian stimulation can reduce the rates of multiples from that observed with gonadotropin and CC treatment .
BACKGROUND	NCT 01044862 .

###24979398
OBJECTIVE	To evaluate the efficacy and safety of AM-111 , a c-Jun N-terminal Kinase ( JNK ) ligand , in patients with acute sensorineural hearing loss ( ASNHL ) .
METHODS	Prospective , double-blind , randomized , placebo-controlled study with follow-up visits on Days 3 , 7 , 30 , and 90 .
METHODS	Twenty-five European sites ( academic tertiary referral centers , private ENT practices ) .
METHODS	Approximately 210 patients aged 18 to 61 years presenting within 48 hours after acute acoustic trauma or idiopathic sudden sensorineural hearing loss with mean hearing loss of 30 dB or greater at the 3 most affected contiguous test frequencies .
METHODS	Single-dose intratympanic injection of AM-111 ( 0.4 or 2.0 mg/ml ) or placebo ; optionally , oral prednisolone if hearing improvement was less than 10 dB at Day 7 .
METHODS	Efficacy was assessed by absolute hearing improvement ( primary end point , Day 7 ) , percentage hearing improvement , complete hearing recovery , speech discrimination improvement , and complete tinnitus remission .
METHODS	Safety was evaluated by the frequency of clinically relevant hearing deterioration and adverse events .
RESULTS	The study failed to demonstrate a treatment benefit for the entire study population because mild-to-moderate ASNHL cases showed unexpectedly strong spontaneous recovery .
RESULTS	In severe-to-profound ASNHL patients ( threshold 60 dB ) , AM-111 0.4 mg/ml showed statistically significant , clinically relevant , and persistent improvements in hearing and speech discrimination and higher tinnitus remission compared with placebo .
RESULTS	The study drug and the intratympanic injections were well tolerated .
CONCLUSIONS	The study established proof of concept for AM-111 in the treatment of severe-to-profound ASNHL .
CONCLUSIONS	Control for spontaneous hearing recovery is essential for ASNHL studies .

###25058680
OBJECTIVE	The objective of this study was to assess the 48-week virological efficacy of atazanavir/ritonavir ( ATV/r ) monotherapy vs. ATV/r along with two nucleoside reverse transcriptase ( NRTIs ) in HIV-1 treated individuals with HIV-RNA less than 50copies/ml .
METHODS	A multicentre , randomized , open-label , noninferiority trial .
METHODS	HIV-1 treated individuals on ATV/r 300/100mg along with two NRTIs were randomized to receive ATV/r monotherapy or to maintain their antiretroviral regimen .
METHODS	The primary endpoint was the confirmed viral rebound ( CVR : two consecutive HIV-RNA > 50copies/ml ) or treatment discontinuation for any reason .
METHODS	Individuals who experienced CVR on ATV/r monotherapy reintroduced NRTIs and discontinued the study if HIV-RNA was more than 50copies/ml after 12 weeks since reintensification .
RESULTS	One hundred and three patients enrolled .
RESULTS	By week 48 , 11 patients in ATV/r arm and two in ATV/r along with two NRTIs experienced CVR ; four ( 8 % ) patients in ATV/r and eight ( 15 % ) in ATV/r along with two NRTIs discontinued .
RESULTS	At the 48-week primary efficacy analysis ( re-intensification = failure ) , treatment success was 73 % in ATV/r arm and 85 % in ATV/r along with two NRTIs [ difference -12.1 % , 95 % confidence interval ( 95 % CI ) -27.8 to 2.1 ] .
RESULTS	According to the analysis considering re-intensification is equal to success , treatment success was 92 % in ATV/r arm and 85 % in the ATV/r along with two NRTIs arm ( difference 7.5 % , 95 % CI -4.7 to 19.8 ) .
RESULTS	At CVR , no mutation was observed in ATV/r arm and reintensification with NRTIs was effective in all individuals .
RESULTS	Overall , Grade 3-4 ( P = 0.003 ) and grade 3-4 drug-related ( P = 0.027 ) adverse events were less frequent in ATV/r arm .
RESULTS	A significant increase in total and low-density lipoprotein ( LDL ) - cholesterol was observed as well as a significant improvement in high-density lipoprotein ( HDL ) - cholesterol , fasting glucose , liver fibrosis and alkaline phosphatase was observed in ATV/r monotherapy in comparison with ATV/r along with two NRTIs .
CONCLUSIONS	ATV/r monotherapy treatment simplification showed lower virological efficacy in comparison with maintaining triple therapy ; NRTIs reintroduction was effective in all the individuals .

###25319729
BACKGROUND	The progressive nature of glaucoma and its growing incidence make its therapy an important target for research .
BACKGROUND	The role of oxidative damage in the pathogenesis of glaucoma makes antioxidants such as saffron extract an attractive target for potential clinical use .
BACKGROUND	Herein , we evaluate the effect of aqueous saffron extract on intraocular pressure ( IOP ) in eyes with primary open-angle glaucoma ( POAG ) .
METHODS	Thirty-four eyes of 34 clinically stable POAG patients receiving treatment with timolol and dorzolamide eye drops were enrolled in this prospective , comparative , randomized interventional pilot study .
METHODS	Eligible subjects were randomized to receive 30 mg/day aqueous saffron extract orally ( 17 subjects , 17 eyes ) or placebo ( 17 subjects , 17 eyes ) for one month as an adjunct to timolol and dorzolamide .
METHODS	Following treatment , both study groups entered a one-month wash-out period .
METHODS	The main outcome measure was IOP during treatment and after the wash-out period .
RESULTS	Mean baseline IOP was 12.9 3.7 versus 14.0 2.5 mmHg in the saffron and control groups , respectively ( p = 0.31 ) .
RESULTS	After three weeks of treatment , IOP was significantly decreased to 10.9 3.3 mmHg in the saffron group as compared to 13.5 2.3 mmHg in the control group ( p = 0.013 ) .
RESULTS	At four weeks , IOP was still significantly lower in the saffron group ( 10.6 3.0 versus 13.8 2.2 mmHg , p = 0.001 ) .
RESULTS	At the end of the wash-out period , IOP was 12.9 3.0 in the saffron group versus 14.2 2.0 mmHg in the control group ( p = 0.175 ) .
RESULTS	None of the patients experienced side effects during the study and wash-out period .
CONCLUSIONS	Oral aqueous saffron extract seems to exert an ocular hypotensive effect in primary open-angle glaucoma .
CONCLUSIONS	This effect became evident after three weeks of therapy.The current study was registered at the International Clinical Trials Registry Platform ( ICTRP ) as IRCT201201278832N1 .

###25042729
OBJECTIVE	To compare standard-of-care grid laser photocoagulation versus intravitreal ranibizumab ( IVR ) versus a combination of both in the treatment of chronic ( > 3 months ) macular oedema secondary to branch retinal vein occlusion .
METHODS	Prospective , randomized , multicentre clinical trial .
METHODS	Thirty patients with a best-corrected visual acuity ( BCVA ) between 20/320 and 20/40 were randomized 1:1:1 to receive grid laser or three monthly injections of 0.5 mg IVR or both followed by 3 months of observation .
RESULTS	Mean change from baseline BCVA at month 6 was +2 letters [ laser ; 0.04 logMAR , 95 % confidence interval ( -0.17 ; 0.25 ) ] , +17 letters [ IVR ; 0.34 ( 0.19 ; 0.5 ) ] and +6 letters [ combination ; 0.12 ( 0.01 ; 0.24 ) ] ( IVR versus laser p = 0.02 and IVR versus combination p = 0.02 ) .
RESULTS	At month 3 , mean improvement in central retinal thickness ( CRT ) was 90.6 m ( laser ) ( -18.65 ; 199.8 ) , 379.5 m ( IVR ) ( 204.2 ; -554.8 ) , and 248 m ( 167.2 ; -328.8 ) ( combination ) ( IVR versus laser p = 0.005 , laser versus combination p = 0.02 ) .
RESULTS	During the observation period , CRT improved in laser [ 37.6 m ( -66.82 ; 142.0 ) ] , but deteriorated in IVR [ -142.4 m ( -247.6 ; -37.16 ) ] and combination [ -171.7 m ( -250.4 ; -92.96 ) ] ( laser versus IVR p = 0.01 , laser versus combination p = 0.002 ) indicating recurrent oedema .
RESULTS	Less laser retreatments ( at 8 weeks ) were required in combination group ( 2/10 ) than grid group ( 7/10 ) .
CONCLUSIONS	Six-month results suggest that ranibizumab may be superior to grid laser in improving visual acuity .
CONCLUSIONS	Grid combined with IVR neither enhanced functional and morphological improvement of IVR nor did it prevent or prolong recurrence of oedema .
CONCLUSIONS	In IVR groups , CRT increased slowly after stopping injections , whereas improvement in visual acuity was sustained , indicating that morphological changes occur prior to functional impairment .

###24940305
BACKGROUND	Recently some plasma biomarkers of inflammation have been recognized as important cardiovascular risk factors .
BACKGROUND	There is little information about the effects of aerobic exercise training on these biomarkers and the risk of metabolic complications in obese type 2 diabetes patients .
OBJECTIVE	To compare the impact of moderate versus mild aerobic exercise training on the inflammatory cytokines in obese type 2 diabetic patients .
METHODS	Fifty obese type 2 diabetic patients of both sexes with body mass index ( BMI ) varying from 31 to 36 kg/m ( 2 ) , non smokers , free from respiratory , kidney , liver , metabolic and neurological disorders , participated in this study .
METHODS	Their age ranged from 40 to 55 years .
METHODS	The subjects were included into two equal groups ; the first group ( A ) received moderate aerobic exercise training .
METHODS	The second group ( B ) received mild aerobic exercise training , three times / week for 3 months .
RESULTS	The mean values of leptin , TNF - alpha , IL2 , IL4 , IL6 , HOMA-IR and HBA1c were significantly decreased in group ( A ) and group ( B ) .
RESULTS	Also , there were significant differences between both groups after treatment .
CONCLUSIONS	Moderate aerobic exercise training modulates inflammatory cytokines more than mild aerobic exercise training in obese type 2 diabetic patients .

###25616944
BACKGROUND	Inguinal field block ( IFB ) is a recommended technique for pain control after inguinal hernia repair but is also underused by surgeons .
BACKGROUND	Currently , there is no decisive evidence on which technique , IFB or spinal anesthesia block ( SAB ) , provides better pain control during the first day after hernia repair .
BACKGROUND	In this study , we compared ultrasound-guided IFB performed by anesthesiologists and SAB for pain control during the first day after hernia repair .
METHODS	We compared static and dynamic pain scores measured with a numerical rating scale in 86 male patients scheduled for elective unilateral inguinal hernia repair with either ultrasound-guided IFB ( n = 42 ) or SAB ( n = 44 ) .
RESULTS	Dynamic and static pain at 4 hours ( P < .01 , r > 0.34 , `` large effect size '' ) , and dynamic pain the morning after operation ( P = .04 , r > 0.20 , `` medium effect size '' ) were less in the field block group compared with the SAB group .
RESULTS	Postoperative analgesic consumption was reduced during hospital stay ( P = .005 , r > 0.34 , `` large effect size '' ) and for 7 postoperative days in the field block group ( P = .03 , r > 0.20 , `` medium effect size '' ) .
CONCLUSIONS	In this study , ultrasound-guided IFB provided lesser dynamic pain scores during the first postoperative day and reduced use of analgesics for 1 week compared with spinal anesthesia after inguinal hernia repair .
CONCLUSIONS	Our technique could become a substitute performed by anesthesiologists in settings in which IFB is not performed routinely by surgeons .

###24633589
OBJECTIVE	Whole-body vibration ( WBV ) training may offer an efficient option to improve physical performance of nursing home residents , but the feasibility of WBV training among frail elderly who require continuous institutional care is still open .
METHODS	Fifteen nursing home residents ( mean age 84years ) with low physical performance ( mean SPPB score 3.7 ) participated in this blinded , randomized controlled pilot trial .
METHODS	The intervention was either a 10week , twice-a-week progressive vibration training with slight exercises done on a side-alternating device or similar sham training without vibration .
METHODS	Physical performance was assessed with Short Physical Performance Battery ( SPPB ) , Timed Up and Go , walk speed and grip strength tests .
RESULTS	Low 12Hz frequency was well tolerated with mean 95 % compliance in contrast to higher 18Hz ( or 26Hz ) frequency , which was poorly ( < 30 % ) tolerated .
RESULTS	While treatment effects were not significant , the mean change in SPPB score was 0.4 ( range from -2 to +4 ) in the WBV group in contrast to -0.1 ( from -3 to +3 ) in the sham group .
CONCLUSIONS	Frail nursing home residents form not only a potential but also challenging target group for physical rehabilitation with WBV .
CONCLUSIONS	Side-alternating WBV training performed at low 12Hz frequency was found generally feasible , whereas higher frequencies appeared formidable .
CONCLUSIONS	Nevertheless , it is possible that physical performance of some frail elderly without contraindications to WBV can be improved with this type of rapidly executable physical training .

###24985000
OBJECTIVE	Preclinical investigations support the use of probiotics in the treatment of hypercholesterolemia , but clinical evidence is often contrasting .
OBJECTIVE	The aim of this study was to evaluate the effects of a probiotic formulation containing three Bifidobacterium strains on lipid profiles in children affected by primary dyslipidemia .
METHODS	Thirty-eight children with dyslipidemia , ages 10.8 2.1 y , were enrolled in a randomized , double-blind , placebo-controlled cross-over study .
METHODS	After a 4-wk diet run-in period , the children received probiotics ( B. animalis subspecies lactis MB 2409 , B. bifidum MB 109B , and B. longum subspecies longum BL04 ) or placebo for 3 mo. .
METHODS	After 1 mo , wash-out treatments were switched .
METHODS	Astrict dietary evaluation concerning satured fatty acids and cholesterol content , STEP I diet accordingly , was performed by a dietitian who examined the weekly dietary diary at each visit .
RESULTS	Baseline lipid profile was ( mean SD ) : total cholesterol ( TC ) 222.8 23.2 mg/dL , high-density lipoprotein cholesterol ( HDL-C ) 55.8 12.2 mg/dL , triglycerides ( TG ) 99.0 61.7 mg/dL , and low-density lipoprotein cholesterol ( LDL-C ) 147.2 21.9 mg/dL .
RESULTS	After 3 mo of probiotic treatment , the lipid profile was : TC 211.9 27.3 mg/dL , HDL-C 60.7 14.2 mg/dL , TG 79.5 34.5 mg/dL , and LDL-C 135.3 24.2 mg/dL .
RESULTS	Compared with placebo , probiotics reduced TC by 3.4 % ( P = 0.02 ) and LDL-C by 3.8 % ( P = 0.001 ) .
RESULTS	No significant dietary change occurred through the study and no relevant adverse effects were observed .
CONCLUSIONS	Treatment with a Bifidobacterium probiotic formulation was well tolerated and useful in combination with to diet therapy .
CONCLUSIONS	Children with dyslipidemia benefited from this approach , although the results need to be confirmed by larger controlled studies .

###24812024
BACKGROUND	Lower concentrations of serum bilirubin , an endogenous antioxidant , have been associated with risk of many smoking-related diseases , including lung cancer and cardiovascular disease , and current smokers are reported to have lower bilirubin levels than nonsmokers and past smokers .
BACKGROUND	This study evaluates the effects of smoking cessation on bilirubin levels .
METHODS	In a secondary analysis of a 6-week placebo-controlled trial of naltrexone for smoking cessation , indirect and total bilirubin concentrations were evaluated at baseline and following smoking cessation .
METHODS	Individuals who were continuously abstinent for 6 weeks ( n = 155 ) were compared to those who were not ( n = 193 ) .
METHODS	Participants reported smoking 20 cigarettes daily at baseline and received smoking cessation counseling , 21 mg nicotine patch daily , and either placebo or 1 of 3 doses of naltrexone ( 25 , 50 , or 100mg ) for 6 weeks .
METHODS	Change in indirect and total bilirubin following the quit date was measured at Weeks 1 , 4 , and 6 compared to baseline .
RESULTS	Individuals who were continuously abstinent from smoking , independent of naltrexone condition , showed a significantly greater mean increase in indirect ( ~ unconjugated ) bilirubin ( 0.06 mg/dl , SD = 0.165 ) compared to those who did not ( mean = 0.02 , SD = 0.148 , p = .015 ) .
RESULTS	Similar results were obtained for total bilirubin ( p = .037 ) .
CONCLUSIONS	Smoking cessation is followed by increases in bilirubin concentration that have been associated with lower risk of lung cancer and cardiovascular disease .

###25415777
BACKGROUND	Levobupivacaine has less toxic potential on both the cardiovascular and central nervous system and has been widely used for postoperative epidural analgesia in surgical patients .
BACKGROUND	However , there are few reports on the efficacy of epidural levobupivacaine in outpatients with lumbosacral radiculopathy .
BACKGROUND	This study was carried out to evaluate the comparative efficacy of levobupivacaine and ropivacaine for epidural block in outpatients with degenerative spinal disease and sciatica .
OBJECTIVE	We studied 32 patients ( 19 men and 13 women ) with degenerative spinal disease and sciatica .
METHODS	The study was performed in a prospective , randomized , double blind , and crossover fashion .
METHODS	Treatment room for outpatients .
METHODS	The epidural block was produced with a caudal approach ( 0.125 % levobupivacaine or 0.2 % ropivacaine , 15 mL ) .
METHODS	The upper level of analgesia , lumbosacral pain , motor blockade , and hemodynamic changes were evaluated by pin prick , visual analogue scale ( VAS ) , Bromage scale , and arterial blood pressure and heart rate at 15 , 30 , 60 , and 90 minutes after epidural block , respectively .
METHODS	The recovery time to mobilization , ambulation , and spontaneous micturition were measured .
RESULTS	There were no significant differences ( P < 0.05 ) in the upper level of analgesia , VAS , and Bromage scale between 0.125 % levobupivacaine and 0.2 % ropivacaine throughout the time course .
RESULTS	There were no significant differences in the recovery times to mobilization , ambulation , and spontaneous micturition between 0.125 % levobupivacaine and 0.2 % ropivacaine .
RESULTS	There were no significant differences in arterial blood pressure and heart rate between the 2 trials throughout the time course .
CONCLUSIONS	The results showed that 0.125 % levobupivacaine and 0.2 % ropivacaine for epidural block by a caudal approach provide similar lumbosacral pain relief , hemodynamic effects , and the degree and the recovery of motor blockade in outpatients with degenerative spinal disease and sciatica .

###25399616
BACKGROUND	Because excess sebum and/or metabolites of sebum induce skin problems , cleansers that can remove those kinds of sebum are sought after .
BACKGROUND	However , many people , especially who have little facial sebum , are afraid to wash off sebum well because that may induce dry skin .
BACKGROUND	This concern may be caused by the result that cleansers with a high cleansing ability tend to decrease not only facial sebum but also natural moisturizing factors and intercellular lipids that are essential for cutaneous function .
BACKGROUND	Recently , we have developed a new cleanser based on sodium laureth carboxylate and alkyl carboxylates ( AEC/soap ) that cleans sebum well without penetrating the stratum corneum .
OBJECTIVE	This trial was aim to clarify the effects of sebum removal by AEC/soap-based cleanser on the induction of dry skin .
METHODS	We designed a controlled single blind parallel trial .
METHODS	Thirty female subjects with mild dry skin were assigned randomly to two groups : one group used AEC/soap-based cleanser while the other group kept using their usual facial cleanser twice a day for 4weeks in the winter season .
RESULTS	Using a colored artificial sebum mixture , it was demonstrated that this cleanser washed sebum well .
RESULTS	Following usage of this cleanser , their dry skin improved rather than worsen which was indicated by instrumental analysis and visual assessment .
RESULTS	These improvements were recognized by subjects .
CONCLUSIONS	These results suggest that AEC/soap-based cleanser washes off facial sebum well , but it has little effect on the induction of dry skin because of less penetration into stratum corneum .

###24477028
OBJECTIVE	The present study evaluated the effects of pioglitazone treatment on the incidence of primary cardiovascular events in Japanese subjects with type 2 diabetes mellitus at high risk of stroke .
METHODS	A prospective , multicenter , randomized , open label , comparative study was conducted among diabetic patients recruited from 50 medical institutions nationwide .
METHODS	A total of 522 patients with hypertension and/or dyslipidemia who had one or more silent cerebral infarcts , advanced carotid atherosclerosis or microalbuminuria at baseline were randomly treated with ( n = 254 ) or without pioglitazone ( n = 268 ) and observed for a medium of 672 days .
METHODS	The hypertension and dyslipidemia were concurrently treated according to the respective treatment guidelines .
METHODS	The primary outcome was the time to the first occurrence of a composite of all-cause death , nonfatal cerebral infarction and nonfatal myocardial infarction .
RESULTS	Treatment with pioglitazone resulted in significant reductions in the levels of HbA1c , diastolic blood pressure and LDL-cholesterol and a significant increase in the levels of HDL-cholesterol .
RESULTS	The pioglitazone non-users exhibited a significant reduction in the LDL-cholesterol levels alone .
RESULTS	Primary events were registered during the study period in nine patients in the pioglitazone group and 10 patients in the non-pioglitazone group .
RESULTS	The difference in the cumulative incidence of the primary outcome was not significant between the two groups ( 1.8 % per year ) .
CONCLUSIONS	Pioglitazone therapy produces immediate and effective improvements in glycemic control , diastolic blood pressure and lipid profiles .
CONCLUSIONS	While this study was too underpowered to determine the effects of pioglitazone on the incidence of cardiovascular events , the results indicated that two years of pioglitazone treatment did not produce any statistically significant reductions in the rate of primary cardiovascular events .

###24362907
OBJECTIVE	Chemotherapy-induced peripheral neuropathy is frequently a dose-limiting factor in cancer treatment and may cause pain and irreversible function loss in cancer survivors .
OBJECTIVE	We tested whether alpha-lipoic acid ( ALA ) could decrease the severity of peripheral neuropathy symptoms in patients undergoing platinum-based chemotherapy .
METHODS	Cancer patients 18 years or older were randomly selected to receive either 600 mg ALA or a placebo three times a day orally for 24 weeks while receiving chemotherapy regimens including cisplatin or oxaliplatin .
METHODS	Neuropathy was measured by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity ( FACT/GOG-Ntx ) scale and the NCI Common Toxicity Criteria for Adverse Events neurotoxicity grades .
METHODS	Results from timed functional tests and the Brief Pain Inventory ( BPI ) were secondary endpoints .
RESULTS	Seventy of 243 ( 29 % ) patients completed the study ( 24 weeks ) .
RESULTS	Both the ALA and the placebo arms had a comparable drop-out rate .
RESULTS	No statistically significant differences were found between the ALA and the placebo groups for FACT/GOG-Ntx scores , BPI scores , and patients ' functional outcomes .
CONCLUSIONS	This strategy of oral ALA administration was ineffective at preventing neurotoxicity caused by oxaliplatin or cisplatin .
CONCLUSIONS	High attrition rates due to poor patient compliance and manner of dosage administration in this trial demonstrated a lack of feasibility for this intervention .
CONCLUSIONS	Future studies to explore ALA as a neuroprotective agent should take heed of the barriers confronted in this study .

###24907643
BACKGROUND	Single procedure success rates of pulmonary vein isolation ( PVI ) in patients with paroxysmal atrial fibrillation ( PAF ) are still unsatisfactory .
BACKGROUND	In patients with persistent atrial fibrillation ( AF ) , ablation of complex fractionated atrial electrograms ( CFAEs ) after PVI results in improved outcomes .
OBJECTIVE	We aimed to investigate if PAF-patients with intraprocedurally sustained AF after PVI might benefit from additional CFAE ablation .
METHODS	A total of 1134 consecutive patients underwent a first catheter ablation procedure of PAF between June 2008 and December 2012 .
METHODS	In most patients , AF was either not inducible or terminated during PVI .
METHODS	In 68 patients ( 6 % ) , AF sustained after successful PVI .
METHODS	These patients were randomized to either cardioversion ( PVI-alone group ; n = 33 ) or additional CFAE ablation ( PVI+CFAE group ; n = 35 ) and followed up every 1-3 months and serial Holter recordings were also obtained .
METHODS	The primary end point was the recurrence of AF/atrial tachycardia ( AT ) after a blanking period of 3 months .
RESULTS	Procedure duration ( 127 6 minutes vs 174 10 minutes ) , radiofrequency application time ( 44 3 minutes vs 74 5 minutes ) , and fluoroscopy time ( 26 2 minutes vs 41 3 minutes ) were longer in the PVI+CFAE group ( all P < .001 ) .
RESULTS	In 30 of 35 patients ( 86 % ) in the PVI+CFAE group , ablation terminated AF .
RESULTS	There was no significant group difference with respect to freedom from AF/AT ( 22 of 33 [ 67 % ] vs 22 of 35 [ 63 % ] ; P = .66 ) .
RESULTS	Subsequently , 10 of 11 patients in the PVI-alone group ( 91 % ) and 11 of 13 patients in PVI+CFAE group ( 85 % ) underwent repeat ablation ( P = 1.00 ) .
RESULTS	Overall , 29 of 33 [ 88 % ] vs 30 of 35 [ 86 % ] patients ( P = 1.00 ) were free from AF/AT after 1.4 0.1 vs 1.4 0.2 ( P = .87 ) procedures .
CONCLUSIONS	Patients with sustained AF after PVI in a PAF cohort are rare .
CONCLUSIONS	Regarding AF/AT recurrence , these patients did not benefit from further CFAE ablation compared to PVI alone , but are exposed to longer procedure duration , fluoroscopy time , and radiofrequency application time .

###24920169
OBJECTIVE	To assess the prevalence of gastrointestinal toxicity in dogs receiving chemotherapy with vincristine and cyclophosphamide and the efficacy of maropitant citrate ( Cerenia , Zoetis ) in reducing these events .
METHODS	Dogs receiving chemotherapy with cyclophosphamide or vincristine were randomised to either receive maropitant or not in the period immediately after treatment and for 4 days afterwards .
METHODS	Owners completed a diary of adverse events following treatment .
RESULTS	Adverse events occurred in 40/58 ( 69 % ) dogs in the vincristine group .
RESULTS	Most of these adverse events were mild and included : lethargy ( 62 % ) , appetite loss ( 43 % ) , diarrhoea ( 34 % ) and vomiting ( 24 % ) .
RESULTS	Adverse events occurred in 34/42 ( 81 % ) dogs treated with cyclophosphamide .
RESULTS	Most of these adverse events were mild and included : lethargy ( 62 % ) , diarrhoea ( 36 % ) , appetite loss ( 36 % ) and vomiting ( 21 % ) .
RESULTS	There was no difference in total clinical score , vomiting , diarrhoea , appetite loss or lethargy score between dogs treated with maropitant and non-treated dogs in either the vincristine or cyclophosphamide groups .
CONCLUSIONS	Chemotherapy-related side effects are frequent but usually mild in dogs receiving vincristine or cyclophosphamide .
CONCLUSIONS	Prophylactic administration of maropitant does not reduce the frequency of adverse events and maropitant should be administered only as required for individual cases .

###25446610
OBJECTIVE	To report secondary efficacy endpoints of Radiation Therapy Oncology Group protocol 0247 , primary endpoint analysis of which demonstrated that preoperative radiation therapy ( RT ) with capecitabine plus oxaliplatin achieved a pathologic complete remission prespecified threshold ( 21 % ) to merit further study , whereas RT with capecitabine plus irinotecan did not ( 10 % ) .
METHODS	A randomized , phase 2 trial evaluated preoperative RT ( 50.4 Gy in 1.8-Gy fractions ) with 2 concurrent chemotherapy regimens : ( 1 ) capecitabine ( 1200 mg/m ( 2 ) / d Monday-Friday ) plus irinotecan ( 50 mg/m ( 2 ) / wk 4 ) ; and ( 2 ) capecitabine ( 1650 mg/m ( 2 ) / d Monday-Friday ) plus oxaliplatin ( 50 mg/m ( 2 ) / wk 5 ) for clinical T3 or T4 rectal cancer .
METHODS	Surgery was performed 4 to 8 weeks after chemoradiation , then 4 to 6 weeks later , adjuvant chemotherapy ( oxaliplatin 85 mg/m ( 2 ) ; leucovorin 400 mg/m ( 2 ) ; 5-fluorouracil 400 mg/m ( 2 ) ; 5-fluorouracil 2400 mg/m ( 2 ) ) every 2 weeks 9 .
METHODS	Disease-free survival ( DFS ) and overall survival ( OS ) were estimated univariately by the Kaplan-Meier method .
METHODS	Local-regional failure ( LRF ) , distant failure ( DF ) , and second primary failure ( SP ) were estimated by the cumulative incidence method .
METHODS	No statistical comparisons were made between arms because each was evaluated individually .
RESULTS	A total of 104 patients ( median age , 57 years ) were treated ; characteristics were similar for both arms .
RESULTS	Median follow-up for RT with capecitabine/irinotecan arm was 3.77 years and for RT with capecitabine/oxaliplatin arm was 3.97 years .
RESULTS	Four-year DFS , OS , LRF , DF , and SP estimates for capecitabine/irinotecan arm were 68 % , 85 % , 16 % , 24 % , and 2 % , respectively .
RESULTS	The 4-year DFS , OS , LRF , DF , and SP failure estimates for capecitabine/oxaliplatin arm were 62 % , 75 % , 18 % , 30 % , and 6 % , respectively .
CONCLUSIONS	Efficacy results for both arms are similar to other reported studies but suggest that pathologic complete remission is an unsuitable surrogate for traditional survival metrics of clinical outcome .
CONCLUSIONS	Although it remains uncertain whether the addition of a second cytotoxic agent enhances the effectiveness of fluorouracil plus RT , these results suggest that further study of irinotecan may be warranted .

###24849450
OBJECTIVE	To investigate the effect of different doses of dexmedetomidine ( Dex ) on early postoperative cognitive dysfunction in elderly patients undergoing laparoscopic surgery for colorectal cancer .
METHODS	Eighty ASAI-III elderly patients ( over 65 years ) were randomized equally into 4 groups including a control group without dexmedetomidine and 3 dexmedetomidine groups ( groups D1 , D2 , and D3 ) with loading dexmedetomidine doses of 0.2 , 0.5 , and 0.8 g/kg and maintenance doses of 0.2 , 0.5 , and 0.8 gkg ( -1 ) h ( -1 ) , respectively .
METHODS	Dex was discontinued 30 min before the end of surgery .
METHODS	The time of operation , adverse reactions , time from the end of surgery to spontaneous breathing recovery ( TR ) , time from spontaneous breathing recovery to opening eyes ( TO ) , and time from opening eyes to extubation ( TE ) were recorded .
METHODS	Mini-Mental State ( MMSE ) test was used to assess the cognitive function 1 day before and at 1 day and 3 days after the operation .
RESULTS	The incidence of postoperative cognitive dysfunction ( POCD ) was significantly lower in groups D2 and D3 than in the control group and group D1 ( P < 0.05 ) .
RESULTS	The incidences of hypotension and bradycardia were the highest in group D3 ( P < 0.05 ) , which also had longer significantly TO and TE than the other 3 groups ( P < 0.05 ) .
CONCLUSIONS	Dexmedetomidine with a loading dose of 0.5 g/kg followed by maintenance doses of 0.5 and 0.8 gkg ( -1 ) h ( -1 ) ( preferentially 0.5 gkg ( -1 ) h ( -1 ) ) can reduce the incidence of POCD in elderly patients undergoing laparoscopic surgery for colorectal cancer .

###24613373
OBJECTIVE	The main objective of the current investigation was to compare a single wall puncture to vessel transfixing on the success of radial artery cannulation by resident physicians .
METHODS	The study was a prospective and randomized investigation .
METHODS	Twelve anesthesiology residents performed radial arterial insertions in 126 patients using both the single wall and vessel transfixing technique in random order .
METHODS	The primary outcome was successful cannulation of the radial artery in 4 or less attempts .
METHODS	Other data collected included the total number of attempts and total time to catheter cannulation .
RESULTS	Successful radial artery cannulation was achieved in 88 % and 86 % of patients using the transfixing technique and single wall group , respectively ( difference 2 % ; 95 % CI , 14-9 , P = 0.8 , Fisher exact test ) .
RESULTS	Cannulation was successfully on the first attempt in 38 % of the transfixing compared to 54 % using the single wall technique ( difference -- 16 % ; 95 % CI , 32-2 , P = 0.1 , Fisher Exact test ) .
RESULTS	The median ( interquartile range ) time to successful cannulation was longer in the transfixing group , 105 ( 69-176 ) seconds compared to 65 ( 25-114 ) seconds in the single puncture group ( P = .009 , log-rank test ) .
CONCLUSIONS	Our findings suggest that there does not appear to be an advantage of the transfixing technique over the single wall puncture method for cannulating the radial artery by resident physicians .
CONCLUSIONS	Cannulation was achieved in shorter time using the single wall puncture technique even after accounting for differences between residents and prior levels of experience .

###24588854
BACKGROUND	Preclinical studies suggest that growth factors in the early days after stroke improve final outcome .
BACKGROUND	A prior study found three doses of human choriogonadotropin alfa followed by three doses of erythropoietin to be safe after stroke in humans .
BACKGROUND	A proof of concept trial ( REGENESIS ) was initiated but placed on regulatory hold during review of an erythropoietin neuroprotective trial .
BACKGROUND	Due to financial constraints , the trial was largely moved to India , using lower erythropoietin doses , as the REGENESIS-LED trial .
METHODS	Entry criteria included National Institutes of Health Stroke Scale 8-20 , supratentorial ischemic stroke , and 24-48h poststroke at start of therapy .
METHODS	Patients were randomized to three QOD doses of subcutaneous human choriogonadotropin alfa followed by three QD doses of intravenous erythropoietin ( three escalating dose cohorts , 4000-20 ,000 IU/dose ) vs. placebo .
METHODS	Primary outcomes were safety and neurological recovery .
RESULTS	The study was halted early by the sponsor after 96 enrollees .
RESULTS	There was no significant difference across treatment groups in the proportion of patients experiencing death , serious adverse events , or any adverse event .
RESULTS	There was no significant difference in National Institutes of Health Stroke Scale score change from baseline to Day 90 between placebo and active treatment , whether active cohorts were analyzed together or separately , and no exploratory secondary measure of neurological recovery showed a significant difference between groups .
CONCLUSIONS	Administration of human choriogonadotropin alfa followed by erythropoietin is safe after a new ischemic stroke .
CONCLUSIONS	At the doses studied , placebo and active groups did not differ significantly in neurological recovery .
CONCLUSIONS	Study limitations , such as the use of multiple assessors , differences in rehabilitation care , and being underpowered to show efficacy , are discussed .

###25209598
OBJECTIVE	Anticoagulation prophylaxis for stroke is recommended for at-risk patients with either persistent or paroxysmal atrial fibrillation ( AF ) .
OBJECTIVE	We compared outcomes in patients with persistent vs. paroxysmal AF receiving oral anticoagulation .
RESULTS	Patients randomized in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation ( ROCKET-AF ) trial ( n = 14 264 ) were grouped by baseline AF category : paroxysmal or persistent .
RESULTS	Multivariable adjustment was performed to compare thrombo-embolic events , bleeding , and death between groups , in high-risk subgroups , and across treatment assignment ( rivaroxaban or warfarin ) .
RESULTS	Of 14 062 patients , 11 548 ( 82 % ) had persistent AF and 2514 ( 18 % ) had paroxysmal AF .
RESULTS	Patients with persistent AF were marginally older ( 73 vs. 72 , P = 0.03 ) , less likely female ( 39 vs. 45 % , P < 0.0001 ) , and more likely to have previously used vitamin K antagonists ( 64 vs. 56 % , P < 0.0001 ) compared with patients with paroxysmal AF .
RESULTS	In patients randomized to warfarin , time in therapeutic range was similar ( 58 vs. 57 % , P = 0.94 ) .
RESULTS	Patients with persistent AF had higher adjusted rates of stroke or systemic embolism ( 2.18 vs. 1.73 events per 100-patient-years , P = 0.048 ) and all-cause mortality ( 4.78 vs. 3.52 , P = 0.006 ) .
RESULTS	Rates of major bleeding were similar ( 3.55 vs. 3.31 , P = 0.77 ) .
RESULTS	Rates of stroke or systemic embolism in both types of AF did not differ by treatment assignment ( rivaroxaban vs. warfarin , Pinteraction = 0.6 ) .
CONCLUSIONS	In patients with AF at moderate-to-high risk of stroke receiving anticoagulation , those with persistent AF have a higher risk of thrombo-embolic events and worse survival compared with paroxysmal AF .

###25880303
BACKGROUND	Mental illness is a significant and growing problem in Canadian healthcare organizations , leading to tremendous personal , social and financial costs for individuals , their colleagues , their employers and their patients .
BACKGROUND	Early and appropriate intervention is needed , but unfortunately , few workers get the help that they need in a timely way due to barriers related to poor mental health literacy , stigma , and inadequate access to mental health services .
BACKGROUND	Workplace education and training is one promising approach to early identification and support for workers who are struggling .
BACKGROUND	Little is known , however , about what approach is most effective , particularly in the context of healthcare work .
BACKGROUND	The purpose of this study is to compare the impact of a customized , contact-based education approach with standard mental health literacy training on the mental health knowledge , stigmatized beliefs and help-seeking/help-outreach behaviors of healthcare employees .
METHODS	A multi-centre , randomized , two-group parallel group trial design will be adopted .
METHODS	Two hundred healthcare employees will be randomly assigned to one of two educational interventions : Beyond Silence , a peer-led program customized to the healthcare workplace , and Mental Health First Aid , a standardized literacy based training program .
METHODS	Pre , post and 3-month follow-up surveys will track changes in knowledge ( mental health literacy ) , attitudes towards mental illness , and help-seeking/help-outreach behavior .
METHODS	An intent-to-treat , repeated measures analysis will be conducted to compare changes in the two groups over time in terms of the primary outcome of behavior change .
METHODS	Linear regression modeling will be used to explore the extent to which knowledge , and attitudes predict behavior change .
METHODS	Qualitative interviews with participants and leaders will also be conducted to examine process and implementation of the programs .
CONCLUSIONS	This is one of the first experimental studies to compare outcomes of standard mental health literacy training to an intervention with an added anti-stigma component ( using best-practices of contact-based education ) .
CONCLUSIONS	Study findings will inform recommendations for designing workplace mental health education to promote early intervention for employees with mental health issues in the context of healthcare work .
BACKGROUND	May 2014 - ClinicalTrials.gov : NCT02158871 .

###24237006
BACKGROUND	Unconscious survivors of out-of-hospital cardiac arrest have a high risk of death or poor neurologic function .
BACKGROUND	Therapeutic hypothermia is recommended by international guidelines , but the supporting evidence is limited , and the target temperature associated with the best outcome is unknown .
BACKGROUND	Our objective was to compare two target temperatures , both intended to prevent fever .
METHODS	In an international trial , we randomly assigned 950 unconscious adults after out-of-hospital cardiac arrest of presumed cardiac cause to targeted temperature management at either 33C or 36C .
METHODS	The primary outcome was all-cause mortality through the end of the trial .
METHODS	Secondary outcomes included a composite of poor neurologic function or death at 180 days , as evaluated with the Cerebral Performance Category ( CPC ) scale and the modified Rankin scale .
RESULTS	In total , 939 patients were included in the primary analysis .
RESULTS	At the end of the trial , 50 % of the patients in the 33C group ( 235 of 473 patients ) had died , as compared with 48 % of the patients in the 36C group ( 225 of 466 patients ) ( hazard ratio with a temperature of 33C , 1.06 ; 95 % confidence interval [ CI ] , 0.89 to 1.28 ; P = 0.51 ) .
RESULTS	At the 180-day follow-up , 54 % of the patients in the 33C group had died or had poor neurologic function according to the CPC , as compared with 52 % of patients in the 36C group ( risk ratio , 1.02 ; 95 % CI , 0.88 to 1.16 ; P = 0.78 ) .
RESULTS	In the analysis using the modified Rankin scale , the comparable rate was 52 % in both groups ( risk ratio , 1.01 ; 95 % CI , 0.89 to 1.14 ; P = 0.87 ) .
RESULTS	The results of analyses adjusted for known prognostic factors were similar .
CONCLUSIONS	In unconscious survivors of out-of-hospital cardiac arrest of presumed cardiac cause , hypothermia at a targeted temperature of 33C did not confer a benefit as compared with a targeted temperature of 36C .
CONCLUSIONS	( Funded by the Swedish Heart-Lung Foundation and others ; TTM ClinicalTrials.gov number , NCT01020916 . )

###25306247
OBJECTIVE	Dual-process models posit that addictive behaviors are characterized by strong automatic processes that can be assessed with implicit measures .
OBJECTIVE	The present study investigated the potential of a cognitive bias modification paradigm , the Approach-Avoidance Task ( AAT ) , for retraining automatic behavioral tendencies in cigarette smoking .
METHODS	The study was set up as an online intervention .
METHODS	After completing an online survey , 257 smokers were randomly allocated either to one of two experimental conditions ( AAT ) or a waitlist control group .
METHODS	Participants responded to different pictures by pushing or pulling the computer mouse , depending on the format of the picture .
METHODS	Pictures in portrait format depicted smoking-related items and were associated with pushing , pictures in landscape format depicted neutral items and were associated with pulling .
METHODS	One version of the AAT provided individual feedback after each trial whereas the standard version did not .
METHODS	After four weeks , participants were re-assessed in an online survey .
RESULTS	Analyses revealed that the standard AAT , in particular , led to a significant reduction in cigarette consumption , cigarette dependence , and compulsive drive ; no effect was found in the control group .
CONCLUSIONS	Interpretability of the study is constrained by the fact that no active control condition was applied .
CONCLUSIONS	Notwithstanding the limitations , our findings indicate that the AAT might be a feasible instrument to reduce tobacco dependence and can be applied as an online intervention .
CONCLUSIONS	Future studies should investigate whether the effects of behavior therapy can be augmented when combined with retraining interventions .

###24681342
OBJECTIVE	To investigate the safety and adverse event profile of sorafenib plus radioembolization ( Y90 ) compared to Y90 alone in patients awaiting liver transplantation .
METHODS	20 patients with HCC were randomized to Y90 alone ( Group A ) or Y90 + sorafenib ( Group B ) .
METHODS	Adverse events , dose reductions , and peri-transplant complications were assessed .
RESULTS	All patients in the sorafenib group necessitated dose reductions .
RESULTS	Seventeen of 20 patients underwent liver transplantation ; median time-to-transplant was 7.8 months ( range : 4.2-20 .3 ) and similar between groups ( p = 0.35 ) .
RESULTS	In the sorafenib group , there were 4/8 peri-transplant ( < 30 days ) biliary complications ( p = 0.029 ) and 3/8 acute rejections ( p = 0.082 ) ; there were none in the Y90-only group .
RESULTS	Survival rates were 70 % ( Group A ) and 72 % ( Group B ) at 3 years ( p = 0.57 ) .
CONCLUSIONS	The addition of sorafenib to Y90 necessitated dose reductions in all patients awaiting transplantation .
CONCLUSIONS	Preliminary data suggest that the combination was associated with more peri-transplant biliary complications and potentially trended towards more acute rejections .
CONCLUSIONS	Caution should be exercised when considering sorafenib in the transplant setting .
CONCLUSIONS	Further investigation is warranted .

###24318319
OBJECTIVE	The purpose of this prospective randomised trial was to assess whether an intramedullary nail is superior to a sliding hip screw in the treatment of multifragmentary intertrochanteric fractures
METHODS	Eighty patients with a 31-A2 .2 or A2 .3 Arbeitsgemeinschaft fr Osteosynthesefragen/Orthopaedic Trauma Association ( AO/OTA ) intertrochanteric fracture were randomly allocated to fixation with either the Gamma nail or the AMBI sliding hip screw device .
RESULTS	All patients were followed up at one , three , six and 12months postoperatively , except for nine who died .
RESULTS	There was no statistical difference in Parker mobility score between groups .
RESULTS	The Gamma nail group had significantly higher Barthel Index and EuroQol-5D ( EQ-5D ) scores than the AMBI group at 12months .
RESULTS	At the same time , the EQ-5D score had returned to its pre-operative values in the Gamma nail group but not in the AMBI group .
RESULTS	There were no differences in mortality , radiation time and hospital stay .
RESULTS	Duration of the operation , incision length and hip pain occurrence were significantly less in the Gamma nail group .
CONCLUSIONS	Few failures occur when unstable 31-A2 .2 and A2 .3 AO/OTA fractures are fixed with a sliding hip screw .
CONCLUSIONS	Nevertheless , an intramedullary nail seems superior in reconstituting patients to their pre-operative state .

###24806009
BACKGROUND	Both trapeziectomy with ligament reconstruction and tendon interposition and trapeziometacarpal arthrodesis are commonly performed procedures for the treatment of trapeziometacarpal osteoarthritis .
BACKGROUND	The purpose of this study was to compare the outcomes of both treatments for symptomatic osteoarthritis of the thumb trapeziometacarpal joint in a randomized trial .
METHODS	Women who were forty years of age or older were randomized either to trapeziectomy with ligament reconstruction and tendon interposition or to arthrodesis with plate and screws .
METHODS	Patients were evaluated preoperatively and at three and twelve months postoperatively with respect to pain , function ( Patient-Rated Wrist/Hand Evaluation [ PRWHE ] and Disabilities of the Arm , Shoulder and Hand [ DASH ] questionnaires ) , joint motion , strength , complication rate , and patient satisfaction .
RESULTS	Forty-three patients were enrolled .
RESULTS	Since we found significantly more moderate and severe complications following arthrodesis compared with trapeziectomy with ligament reconstruction and tendon interposition ( 71 % versus 29 % ; p = 0.016 ) , the study was prematurely terminated before the sample size necessary to validly compare the two groups was reached .
RESULTS	The higher complication rate for arthrodesis led to an increase in revision surgery ( two of seventeen patients ) .
RESULTS	Significantly more patients in the ligament reconstruction and tendon interposition group ( 86 % ) than in the arthrodesis group ( 53 % ) indicated they would consider the same surgery again under the same circumstances ( p = 0.025 ) .
RESULTS	In both groups , PRWHE and DASH scores significantly improved over time ; however , comparison of the groups showed that the results were similar .
CONCLUSIONS	Women who are forty years or older with trapeziometacarpal osteoarthritis have fewer moderate and severe complications after trapeziectomy with ligament reconstruction and tendon interposition and are more likely to consider the surgery again under the same circumstances than are those who undergo arthrodesis .
CONCLUSIONS	Twelve months after surgery , the PRWHE and DASH scores were similar in both groups .
CONCLUSIONS	We do not recommend routine use of arthrodesis with plate and screws in the treatment of women who are forty years or older with stage-II or III trapeziometacarpal osteoarthritis .

###25875779
OBJECTIVE	To determine dose-dependent effects of T administration on voice changes in women with low T levels .
METHODS	Seventy-one women who have undergone a hysterectomy with or without oophorectomy with total T < 31 ng/dL and/or free T < 3.5 pg/mL received a standardized transdermal estradiol regimen during the 12-week run-in period and were then randomized to receive weekly im injections of placebo or 3 , 6.25 , 12.5 , or 25 mg T enanthate for 24 weeks .
METHODS	Total and free T levels were measured by liquid chromatography-tandem mass spectrometry and equilibrium dialysis , respectively .
METHODS	Voice handicap was measured by self-report using a validated voice handicap index questionnaire at baseline and 24 weeks after intervention .
METHODS	Functional voice testing was performed using the Kay Elemetrics-Computer Speech Lab to determine voice frequency , volume , and harmonics .
RESULTS	Forty-six women with evaluable voice data at baseline and after intervention were included in the analysis .
RESULTS	The five groups were similar at baseline .
RESULTS	Mean on-treatment nadir total T concentrations were 13 , 83 , 106 , 122 , and 250 ng/dL in the placebo , 3 - , 6.25 - , 12.5 - , and 25-mg groups , respectively .
RESULTS	Analyses of acoustic voice parameters revealed significant lowering of average pitch in the 12.5 - and 25-mg dose groups compared to placebo ( P < .05 ) ; these changes in pitch were significantly related to increases in T concentrations .
RESULTS	No significant dose - or concentration-dependent changes in self-reported voice handicap index scores were observed .
CONCLUSIONS	Testosterone administration in women with low T levels over 24 weeks was associated with dose - and concentration-dependent decreases in average pitch in the higher dose groups .
CONCLUSIONS	These changes were seen despite the lack of self-reported changes in voice .

###24330986
OBJECTIVE	To evaluate the efficacy and safety of ER XIE TING GRANULES in children with acute diarrhea .
METHODS	A multicenter , randomized , open-label , parallel-controlled clinical trial was carried out in 15 hospitals during March 2011 to July 2012 .
METHODS	A total of 1489 children with acute diarrhea were enrolled and divided randomly into two groups and treated with ER XIE TING GRANULES ( treatment group ) and smectite powder ( control group ) .
METHODS	The therapeutic efficacy and adverse drug reactions were evaluated after three-day and seven-day therapy.Superiority or non-inferiority test was done for effectiveness of the treatment based on efficacy differ by more than 10 % regarded as the superiority .
RESULTS	Totally 1458 children completed the study , in whom 726 children received ER XIE TING GRANULES and 732 received smectite powder .
RESULTS	After three-day and seven-day therapy , cure rates and total efficacy rates of the treatment group were 44.2 % , 94.1 % , 88.8 % , and 97.9 % separately and higher than those of control group ( 39.3 % , 88.4 % , 83.9 % , 97.4 % ) ( Z = 3.2 , P < 0.01 ; Z = 2.46 , P < 0.05 ) .
RESULTS	There were 520 children with rotavirus infection and in whom 266 cases received ER XIE TING GRANULES and 254 received smectite powder .
RESULTS	For rotavirus enteritis , cure rates and total efficacy rates of the treatment group after three-day and seven-day therapy were 40.6 % , 95.1 % , 89.9 % , and 98.9 % separately and higher than those of control group ( 26.4 % , 84.3 % , 78.8 % , and 96.8 % ) ( Z = 4.807 , P < 0.01 ; Z = 3.519 , P < 0.01 ) .
RESULTS	The lower limits of the 95 % confidence interval of difference of cure rate and total efficacy rates after three-day and seven-day therapy between two groups were less than 10 % .
RESULTS	No obvious drug related adverse reactions were found during the study .
CONCLUSIONS	ER XIE TING GRANULES has the same effect for treatment of acute diarrhea and rotavirus enteritis in children.No obvious drug related adverse reactions were found .

###24463669
OBJECTIVE	To evaluate whether nitrofurantoin prophylaxis prevents postoperative urinary tract infection ( UTI ) in patients receiving transurethral catheterization after pelvic reconstructive surgery .
METHODS	In a randomized , double-blind , placebo-controlled trial , participants undergoing pelvic reconstructive surgery were randomized to 100 mg nitrofurantoin or placebo once daily during catheterization if they were : 1 ) discharged with a transurethral Foley or performing intermittent self-catheterization ; or 2 ) hospitalized overnight with a transurethral Foley .
METHODS	Our primary outcome was treatment for clinically suspected or culture-proven UTI within 3 weeks of surgery .
METHODS	Statistical analysis was performed by 2 and logistic regression .
METHODS	Assuming 80 % power at a P value of .05 , 156 participants were needed to demonstrate a two-thirds reduction in UTI .
RESULTS	Of 159 participants , 81 ( 51 % ) received nitrofurantoin and 78 ( 49 % ) received placebo .
RESULTS	There were no significant differences in baseline demographics , intraoperative characteristics , duration and type of catheterization , or postoperative hospitalization , except a lower rate of hysterectomy in the nitrofurantoin group .
RESULTS	Nitrofurantoin prophylaxis did not reduce the risk of UTI treatment within 3 weeks of surgery ( 22 % UTI with nitrofurantoin compared with 13 % UTI with placebo , relative risk 1.73 , 95 % confidence interval 0.85-3 .52 , P = .12 ) .
RESULTS	Urinary tract infection treatment was higher in premenopausal women , lower in diabetics , and increased with longer duration of catheterization .
RESULTS	In logistic regression adjusting for menopause , diabetes , preoperative postvoid residual volume , creatinine clearance , hysterectomy , and duration of catheterization , there was still no difference in UTI with nitrofurantoin as compared with placebo .
CONCLUSIONS	Prophylaxis with daily nitrofurantoin during catheterization does not reduce the risk of postoperative UTI in patients receiving short-term transurethral catheterization after pelvic reconstructive surgery .
BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT01450800 .
METHODS	I.

###24328357
OBJECTIVE	Statin treatment may impair glucose homeostasis and increase the risk of new-onset diabetes mellitus , although this may depend on the statin , dose and patient population .
OBJECTIVE	We evaluated the effects of pitavastatin 4mg/day on glucose homeostasis in patients with metabolic syndrome in the CAPITAIN trial .
OBJECTIVE	Findings were validated in a subset of patients enrolled in PREVAIL-US .
METHODS	Participants with a well defined metabolic syndrome phenotype were recruited to CAPITAIN to reduce the influence of confounding factors .
METHODS	Validation and comparison datasets were selected comprising phenotypically similar subsets of individuals enrolled in PREVAIL-US and treated with pitavastatin or pravastatin , respectively .
METHODS	Mean change from baseline in parameters of glucose homeostasis ( fasting plasma glucose [ FPG ] , glycated hemoglobin [ HbA1c ] , insulin , quantitative insulin-sensitivity check index [ QUICKI ] and homeostasis model of assessment-insulin resistance [ HOMA-IR ] ) and plasma lipid profile were assessed at 6 months ( CAPITAIN ) and 3 months ( PREVAIL-US ) after initiating treatment .
RESULTS	In CAPITAIN ( n = 12 ) , no significant differences from baseline in HbA1c , insulin , HOMA-IR and QUICKI were observed at day 180 in patients treated with pitavastatin .
RESULTS	A small ( 4 % ) increase in FPG from baseline to day 180 ( P < 0.05 ) , was observed .
RESULTS	In the validation dataset ( n = 9 ) , no significant differences from baseline in glycemic parameters were observed at day 84 ( all comparisons P > 0.05 ) .
RESULTS	Similar results were observed for pravastatin in the comparison dataset ( n = 14 ) .
CONCLUSIONS	Other than a small change in FPG in the CAPITAIN study , neutral effects of pitavastatin on glucose homeostasis were observed in two cohorts of patients with metabolic syndrome , independent of its efficacy in reducing levels of atherogenic lipoproteins .
CONCLUSIONS	The small number of patients and relatively short follow-up period represent limitations of the study .
CONCLUSIONS	Nevertheless , these data suggest that statin-induced diabetogenesis may not represent a class effect .

###24921688
BACKGROUND	Breastfeeding elicits significant protection against respiratory tract infections in infancy .
BACKGROUND	Modulation of respiratory microbiota might be part of the natural mechanisms of protection against respiratory diseases induced by breastfeeding .
OBJECTIVE	To study the association between breastfeeding and nasopharyngeal microbial communities , including all cultivable and noncultivable bacteria .
METHODS	In this observational study , we analyzed the microbiota of infants that had received exclusive breastfeeding ( n = 101 ) and exclusive formula feeding ( n = 101 ) at age 6 weeks and 6 months by 16S-based GS-FLX-titanium-pyrosequencing .
RESULTS	At 6 weeks of age the overall bacterial community composition was significantly different between breastfed and formula-fed children ( nonmetric multidimensional scaling , P = 0.001 ) .
RESULTS	Breastfed children showed increased presence and abundance of the lactic acid bacterium Dolosigranulum ( relative effect size [ RES ] , 2.61 ; P = 0.005 ) and Corynebacterium ( RES , 1.98 ; P = 0.039 ) and decreased abundance of Staphylococcus ( RES , 0.48 ; P 0.03 ) and anaerobic bacteria , such as Prevotella ( RES , 0.25 ; P < 0.001 ) and Veillonella ( RES , 0.33 ; P < 0.001 ) .
RESULTS	Predominance ( > 50 % of the microbial profile ) of Corynebacterium and Dolosigranulum was observed in 45 ( 44.6 % ) breastfed infants compared with 19 ( 18.8 % ) formula-fed infants ( relative risk , 2.37 ; P = 0.006 ) .
RESULTS	Dolosigranulum abundance was inversely associated with consecutive symptoms of wheezing and number of mild respiratory tract infections experienced .
RESULTS	At 6 months of age associations between breastfeeding and nasopharyngeal microbiota composition had disappeared .
CONCLUSIONS	Our data suggest a strong association between breastfeeding and microbial community composition in the upper respiratory tract of 6-week-old infants .
CONCLUSIONS	Observed differences in microbial community profile may contribute to the protective effect of breastfeeding on respiratory infections and wheezing in early infancy .
CONCLUSIONS	Clinical trial registered with www.clinicaltrials.gov ( NCT 00189020 ) .

###25509703
BACKGROUND	With spherical intraocular lens ( IOL ) implantation , unaided vision of cataract patients with pre-existing corneal astigmatism is unsatisfactory because astigmatic spectacles will always be needed for clear vision .
BACKGROUND	Toric IOL has been proven to be a major improvement in cataract surgery for spectacle independence .
BACKGROUND	Aspheric property , reported to improve visual quality in a non-toric IOL , has now been added to toric IOL for even better unaided vision .
OBJECTIVE	To compare visual and aberrometric outcomes of 2 toric IOL , spherical and aspheric , at 3 months after implantation .
METHODS	Cataract surgery was performed in cataract patients with pre-existing corneal astigmatism using 2 types of toric IOLs , a spherical toric IOL , Acrys of SN60T ( Group A ) and a aspheric toric IOL , Acrts of SN6AT , ( Group B ) as a randomized control trial .
METHODS	The uncorrected distance ( UDVA ) and corrected ( CDVA ) distance visual acuities , residual astigmatism , spherical equivalent ( SE ) and spherical aberration were evaluated 3 months after implantation .
RESULTS	The present study included 44 eyes .
RESULTS	No statistically significant difference was found in UDVA , CDVA and residual astigmatism between both groups .
RESULTS	The UDVA of 0.1 logMAR or better was found in 78.26 % in Group A and 85.71 % in Group B.
RESULTS	In Group A , 78.26 % of eyes and in Group B , 76.19 % had a refractive astigmatism value within 0.50 diopter at KP90 ( polar value along the 90-degree meridian ) .
RESULTS	The spherical equivalent ( SE ) was within 0.5 diopter of emmetropia in 91.30 % in Group A and in 80.95 % in Group B. Group B had significantly lower spherical aberration Z ( 4 , 0 ) than Group A.
CONCLUSIONS	Both groups had similar clinical effectiveness for unaided visual acuity , aided visual acuity and astigmatism correction .
CONCLUSIONS	Group B had significantly less spherical aberration induction when compared with Group A.

###24606087
BACKGROUND	The GH-2000 and GH-2004 research groups developed a method for detecting GH misuse in athletes based on the measurement of serum IGF-I and procollagen type III amino-terminal propeptide ( P-III-NP ) .
BACKGROUND	There are reports that IGF-I is also misused by athletes , but currently there is no internationally recognized test designed to detect recombinant human IGF-I misuse .
OBJECTIVE	The objective of the study was to examine the response of serum IGF-I , P-III-NP , and the GH-2000 score to recombinant human ( rh ) IGF-I/rhIGF binding protein-3 ( IGFBP-3 ) administration in recreational athletes .
METHODS	This was a randomized , double-blind , placebo-controlled rhIGF-I/rhIGFBP -3 administration study at Southampton General Hospital ( Southampton , United Kingdom ) .
METHODS	Fifty-six recreational athletes ( 26 women , 30 men ) participated in the study .
METHODS	Participants were randomized to treatment with low-dose ( 30 mg/d ) or high-dose ( 60 mg/d ) rhIGF-I/rhIGFBP -3 complex or placebo for 28 days .
METHODS	Blood was collected throughout the drug administration and washout periods .
METHODS	Serum IGF-I and P-III-NP were measured using commercial immunoassays and GH-2000 scores were calculated .
RESULTS	IGF-I , P-III-NP , and the GH-2000 score rose in response to both low - and high-dose rhIGF-I/rhIGFBP -3 administration .
RESULTS	The relative maximum response of IGF-I ( approximately 4-fold increase in women and men ) was greater than that of P-III-NP ( 40 % -50 % increase in women , 35 % -50 % increase in men ) .
RESULTS	The GH-2000 formulae , which incorporate IGF-I and P-III-NP results , detected up to 61 % of women and 80 % of men in the rhIGF-I/rhIGFBP -3 groups but , using IGF-I concentrations alone , the sensitivity increased to 94 % in both women and men during the administration period .
CONCLUSIONS	The rise in P-III-NP after rhIGF-I/rhIGFBP -3 administration is small compared with that after rhGH administration .
CONCLUSIONS	Although rhIGF-I/rhIGFBP -3 administration can be detected using the GH-2000 score method , a test based on serum IGF-I alone provides better sensitivity .

###25118055
OBJECTIVE	In this corollary analysis of the EXCITE study , we looked at possible differences in baseline risk factors and mortality between subjects excluded from the trial because non-eligible ( n = 216 ) or because eligible but refusing to participate ( n = 116 ) .
METHODS	Baseline characteristics and mortality data were recorded .
METHODS	Survival and independent predictors of mortality were assessed by Kaplan-Meier and Cox regression analyses .
RESULTS	The incidence rate of mortality was higher in non-eligible vs. eligible non-randomized patients ( 21.0 vs. 10.9 deaths/100 persons-year ; P < 0.001 ) .
RESULTS	The crude excess risk of death in non-eligible patients ( HR 1.96 ; 95 % CI 1.36 to 2.77 ; P < 0.001 ) was reduced after adjustment for risk factors which differed in the two cohorts including age , blood pressure , phosphate , CRP , smoking , diabetes , triglycerides , cardiovascular comorbidities and history of neoplasia ( HR 1.60 ; 95 % CI 1.10 to 2.35 ; P = 0.017 ) and almost nullified after including in the same model also information on deambulation impairment ( HR 1.16 ; 95 % CI 0.75 to 1.80 ; P = 0.513 ) .
CONCLUSIONS	Deambulation ability mostly explains the difference in survival rate in non-eligible and eligible non-randomized patients in the EXCITE trial .
CONCLUSIONS	Extending data analyses and outcome reporting also to subjects not taking part in a trial may be helpful to assess the representability of the study population .

###25942482
BACKGROUND	Nutrition can affect the hypothalamus-pituitary-adrenal axis .
BACKGROUND	We hypothesized that early administration of parenteral nutrition ( PN ) during critical illness reduces plasma ACTH and cortisol concentrations and thereby increases the use of corticosteroids .
METHODS	This is a preplanned substudy of a randomized controlled trial ( EPaNIC ) that compared early PN with late PN in 4640 critically ill patients .
METHODS	We investigated the effect of early vs late PN on any steroid treatment and on treatment for 5 days to capture patients with clinical suspicion of adrenal insufficiency , and assessed whether this was related to an effect on septic shock .
METHODS	Also , in a propensity score-matched subgroup ( n = 174 ) of patients not receiving steroids , plasma ACTH and ( free ) cortisol were quantified .
RESULTS	Compared with late PN , more patients on early PN received treatment with corticosteroids ( 26.2 % vs 23.8 % ; P = .05 ) and with corticosteroids for 5 days ( 14.0 % vs 11.9 % ; P = .03 ) .
RESULTS	However , plasma ACTH and ( free ) cortisol concentrations were unaffected and thus could not explain the higher use of corticosteroids with early PN .
RESULTS	Instead , more patients developed new septic shock with early PN ( 17.0 % ) than with late PN ( 14.2 % ) ( P = .01 ) .
RESULTS	In multivariate logistic regression analysis , new septic shock was an independent determinant for 5 days steroid treatment ( odds ratio , 6.25 ; 95 % confidence interval , 4.93-7 .94 ; P < .0001 ) , statistically explaining the effect of early PN on steroid treatment .
CONCLUSIONS	Early PN did not affect plasma concentrations of ACTH and ( free ) cortisol , but increased the incidence of septic shock , which statistically explained why more patients on early PN received corticosteroids .

###24488610
OBJECTIVE	Cyclosporin-A ( CsA ) has been reported to reduce myocardial infarct size in both the experimental and clinical settings .
OBJECTIVE	This protective effect is dependent on its ability to prevent the opening of the mitochondrial permeability transition pore , a critical determinant of cell death in the setting of acute ischaemia-reperfusion injury .
OBJECTIVE	Whether CsA can reduce the extent of peri-operative myocardial injury ( PMI ) in patients undergoing coronary artery bypass graft ( CABG ) surgery is unknown , and is investigated in this randomised controlled clinical trial .
METHODS	78 adult patients undergoing elective CABG surgery were randomised to receive either an intravenous bolus of CsA ( 2.5 mg/kg ) or placebo administered after induction of anaesthesia and prior to sternotomy .
METHODS	PMI was assessed by measuring serum cardiac enzymes , troponin T ( cTnT ) and CK-MB at 0 , 6 , 12 , 24 , 48 and 72 h after surgery .
RESULTS	There was no significant difference in mean peak cTnT levels between control ( n = 43 ) and CsA treatment ( n = 40 ) patients ( 0.560.06 ng/mL with control vs 0.350.05 ng/mL with CsA ; p = 0.07 ) .
RESULTS	However , in higher-risk patients with longer cardiopulmonary bypass times , there was a significant reduction in PMI with CsA therapy ( p = 0.049 ) , with a reduced postoperative cTnT rise by 0.03 ng/mL for every 10 min , when compared with control .
CONCLUSIONS	In patients with longer cardiopulmonary bypass times , a single intravenous bolus of CsA administered prior to CABG surgery reduced the extent of PMI .

###24953541
OBJECTIVE	To evaluate the feasibility of implementing an interdisciplinary , multifaceted knowledge translation intervention within long-term care ( LTC ) and to identify any challenges that should be considered in designing future studies .
METHODS	Cluster randomized controlled trial .
METHODS	Forty LTC homes across the province of Ontario , Canada .
METHODS	LTC teams composed of physicians , nurses , pharmacists , and other staff .
METHODS	Cluster-level feasibility measures , including recruitment , retention , data completion , and participation in the intervention .
METHODS	A process evaluation was completed by directors of care indicating which process/policy changes had been implemented .
RESULTS	Recruitment and retention rates were 22 % and 63 % , respectively .
RESULTS	Good fidelity with the intervention was achieved , including attendance at educational meetings .
RESULTS	After ViDOS , 7 process indicators were being newly implemented by more than 50 % of active intervention homes .
CONCLUSIONS	Despite recruitment and retention challenges , the multifaceted intervention produced a number of policy/process changes and had good intervention fidelity .
CONCLUSIONS	This study is registered at ClinicalTrials.gov NCT01398527 .

###24566243
BACKGROUND	Midazolam has been widely studied for preventing emergence agitation .
BACKGROUND	The authors previously reported that in children with sevoflurane anesthesia , intravenous administration of midazolam ( 0.05 mg/kg ) before the end of surgery reduced the incidence of emergence agitation but prolonged the emergence time .
BACKGROUND	This study was designed to test the hypothesis that a lower midazolam dose could suppress emergence agitation with minimal disturbance of the emergence time in children with sevoflurane anesthesia .
METHODS	In this randomized , double-blind , placebo-controlled trial , 90 children ( 1 to 13 yr of age ) having strabismus surgery were randomized to 1:1:1 to receive 0.03 mg/kg of midazolam , 0.05 mg/kg of midazolam , or saline just before the end of surgery .
METHODS	The primary outcome , the incidence of emergence agitation , was evaluated by using the pediatric anesthesia emergence delirium scale and the four-point agitation scale .
METHODS	The secondary outcome was time to emergence , defined as the time from sevoflurane discontinuation to the time to extubation .
RESULTS	The incidence of emergence agitation was lower in patients given 0.03 mg/kg of midazolam ( 5 of 30 , 16.7 % ) and patients given 0.05 mg/kg of midazolam ( 5 of 30 , 16.7 % ) compared with that in patients given saline ( 13/of 30 , 43.3 % ; P = 0.036 each ) .
RESULTS	The emergence time was longer in patients given 0.05 mg/kg of midazolam ( 17.1 3.4 min , mean SD ) compared with that in patients given 0.03 mg/kg of midazolam ( 14.1 3.6 min ; P = 0.0009 ) or saline ( 12.8 4.1 min ; P = 0.0003 ) .
CONCLUSIONS	Intravenous administration of 0.03 mg/kg of midazolam just before the end of surgery reduces emergence agitation without delaying the emergence time in children having strabismus surgery with sevoflurane anesthesia .

###26234554
BACKGROUND	Non-invasive ventilation is part of the standard of care for treatment of respiratory failure in patients with amyotrophic lateral sclerosis ( ALS ) .
BACKGROUND	The NeuRx RA/4 Diaphragm Pacing System has received Humanitarian Device Exemption approval from the US Food and Drug Administration for treatment of respiratory failure in patients with ALS .
BACKGROUND	We aimed to establish the safety and efficacy of diaphragm pacing with this system in patients with respiratory muscle weakness due to ALS .
METHODS	We undertook a multicentre , open-label , randomised controlled trial at seven specialist ALS and respiratory centres in the UK .
METHODS	Eligible participants were aged 18 years or older with laboratory supported probable , clinically probable , or clinically definite ALS ; stable riluzole treatment for at least 30 days ; and respiratory insufficiency .
METHODS	We randomly assigned participants ( 1:1 ) , via a centralised web-based randomisation system with minimisation that balanced patients for age , sex , forced vital capacity , and bulbar function , to receive either non-invasive ventilation plus pacing with the NeuRx RA/4 Diaphragm Pacing System or non-invasive ventilation alone .
METHODS	Patients , carers , and outcome assessors were not masked to treatment allocation .
METHODS	The primary outcome was overall survival , defined as the time from randomisation to death from any cause .
METHODS	Analysis was by intention to treat .
METHODS	This trial is registered , ISRCTN number 53817913 .
RESULTS	Between Dec 5 , 2011 , and Dec 18 , 2013 , we randomly assigned 74 participants to receive either non-invasive ventilation alone ( n = 37 ) or non-invasive ventilation plus diaphragm pacing ( n = 37 ) .
RESULTS	On Dec 18 , 2013 , the Data Monitoring and Ethics Committee ( DMEC ) recommended suspension of recruitment on the basis of overall survival figures .
RESULTS	Randomly assigned participants continued as per the study protocol until June 23 , 2014 , when the DMEC advised discontinuation of pacing in all patients .
RESULTS	Follow-up assessments continued until the planned end of the study in December , 2014 .
RESULTS	Survival was shorter in the non-invasive ventilation plus pacing group than in the non-invasive ventilation alone group ( median 110 months [ 95 % CI 83-136 ] vs 225 months [ 136-not reached ] ; adjusted hazard ratio 227 , 95 % CI 122-425 ; p = 0009 ) .
RESULTS	28 ( 76 % ) patients died in the pacing group and 19 ( 51 % ) patients died in the non-invasive ventilation alone group .
RESULTS	We recorded 162 adverse events ( 59 events per person-year ) in the pacing group , of which 46 events were serious , compared with 81 events ( 25 events per person-year ) in the non-invasive ventilation alone group , of which 31 events were serious .
CONCLUSIONS	Addition of diaphragm pacing to standard care with non-invasive ventilation was associated with decreased survival in patients with ALS .
CONCLUSIONS	Our results suggest that diaphragmatic pacing should not be used as a routine treatment for patients with ALS in respiratory failure .
BACKGROUND	The National Institute for Health Research Health Technology Assessment Programme ; the Motor Neurone Disease Association of England , Wales , and Northern Ireland .

###25280823
OBJECTIVE	Our study assessed the effectiveness of Interpersonal Psychotherapy ( IPT ) tailored for biomedical patients with depression and pain .
OBJECTIVE	IPT was compared to enhanced treatment as usual ( E-TAU ) among women with co-occurring depression and chronic pain presenting for care at a women 's health or family medicine practice .
OBJECTIVE	We hypothesized that women presenting to urban medical practices with depression and chronic pain would benefit from IPT tailored to address their needs to a greater degree than from E-TAU .
METHODS	We conducted a randomized controlled psychotherapy trial of 61 women from 2 urban medical practices who met criteria for major depressive disorder and chronic pelvic pain .
METHODS	Participants were assigned to receive either 8 sessions of IPT or a facilitated psychotherapy referral to a community mental health center , and assessed for depression , social interactions , and pain at 0 - , 12 - , 24 - , and 36-weeks , with score on the Hamilton Rating Scale for Depression as the primary outcome .
METHODS	Both intent-to-treat ( ITT ) and causal modeling analyses correcting for treatment attendance were conducted .
RESULTS	ITT analyses were not significant .
RESULTS	In causal modeling analyses , participants assigned to IPT showed significantly more improvement for depression and social interactions , but not for pain .
CONCLUSIONS	IPT may be a viable option as part of a comprehensive treatment program for women in medical practices with depression and chronic pain .
BACKGROUND	Clinical Trials.gov , www.clinicaltrials.gov , NCT00895999 .

###25028506
OBJECTIVE	Local transdermal therapy to the breast may achieve effective target-organ drug delivery , while diminishing systemic effects .
OBJECTIVE	We conducted a randomized , double-blind , placebo-controlled phase II trial comparing transdermal 4-hydroxytamoxifen gel ( 4-OHT ) to oral tamoxifen ( oral-T ) in women with ductal carcinoma in situ ( DCIS ) .
METHODS	Twenty-seven pre - and postmenopausal women were randomized to 4-OHT ( 4 mg/day ) or oral-T ( 20 mg/day ) for 6 to 10 weeks before surgery .
METHODS	Plasma , nipple aspirate fluid , and breast adipose tissue concentrations of tamoxifen and its major metabolites were determined by liquid chromatography/tandem mass spectrometry .
METHODS	The primary endpoint was Ki67 labeling in DCIS lesions , measured by immunohistochemistry .
METHODS	In plasma , insulin-like growth factor-1 ( IGFI ) , sex hormone-binding globulin ( SHBG ) , and coagulation protein concentrations were determined .
RESULTS	Posttherapy Ki67 decreased by 3.4 % in the 4-OHT and 5.1 % in the oral-T group ( P 0.03 in both , between-group P = 0.99 ) .
RESULTS	Mean plasma 4-OHT was 0.2 and 1.1 ng/mL in 4-OHT and oral groups , respectively ( P = 0.0003 ) , whereas mean breast adipose tissue concentrations of 4-OHT were 5.8 ng/g in the 4-OHT group and 5.4 ng/g in the oral group ( P = 0.88 ) .
RESULTS	There were significant increases in plasma SHBG , factor VIII , and von Willebrand factor and a significant decrease in plasma IGFI with oral-T , but not with 4-OHT .
RESULTS	The incidence of hot flashes was similar in both groups .
CONCLUSIONS	The antiproliferative effect of 4-OHT gel applied to breast skin was similar to that of oral-T , but effects on endocrine and coagulation parameters were reduced .
CONCLUSIONS	These findings support the further evaluation of local transdermal therapy for DCIS and breast cancer prevention .

###25539597
BACKGROUND	There is a considerable body of evidence supporting the effectiveness of personalized feedback interventions for hazardous alcohol use-whether delivered face-to-face , by postal mail , or over the Internet ( probably now the primary mode of delivery ) .
BACKGROUND	The Check Your Drinking Screener ( CYD ; see www.CheckYourDrinking.net ) is one such intervention .
OBJECTIVE	The current treatment dismantling study assessed which components of personalized feedback interventions were effective in motivating change in drinking .
OBJECTIVE	Specifically , the major objective of this project was to conduct a randomized controlled trial ( RCT ) comparing the impact of the normative feedback and other personalized feedback components of the CYD intervention in the general population .
METHODS	Participants were recruited to take part in an RCT and received either the complete CYD final report , just the normative feedback sections of the CYD , just the personalized feedback components of the CYD , or were assigned to a no-intervention control group .
METHODS	Participants were followed-up at 3 months to assess changes in alcohol consumption .
RESULTS	A total of 741 hazardous drinking participants were recruited for the trial , of which 73 percent provided follow-up data .
RESULTS	Analyses using an intent-to-treat approach found some evidence for the impact of the personalized feedback components of the CYD in reducing alcohol consumption on the variables , number of drinks in a week and AUDIT-C ( p = .028 and .047 respectively ; no impact on highest number of drinks on one occasion ; p = .594 ) .
RESULTS	However , there was no significant evidence of the impact of the normative feedback components ( all p > .3 ) .
CONCLUSIONS	Personalized feedback elements alone could provide an active intervention for hazardous drinkers , particularly in situations where normative feedback information was not available .
BACKGROUND	ClinicalTrials.gov NCT01608763 .

###24435660
OBJECTIVE	Myopia is a significant public health problem , making it important to determine whether a bifocal spectacle treatment involving near prism slows myopia progression in children .
OBJECTIVE	To determine whether bifocal and prismatic bifocal spectacles control myopia in children with high rates of myopia progression and to assess whether the treatment effect is dependent on the lag of accommodation and/or near phoria status .
METHODS	This 3-year randomized clinical trial was conducted in a private practice .
METHODS	A total of 135 ( 73 female and 62 male ) Chinese-Canadian children ( aged 8-13 years ; mean [ SE ] age , 10.29 [ 0.15 ] years ; mean [ SE ] myopia , -3.08 [ 0.10 ] D ) with myopia progression of at least 0.50 D in the preceding year were randomly assigned to 1 of 3 treatments .
METHODS	A total of 128 ( 94.8 % ) completed the trial .
METHODS	Single-vision lenses ( control , n = 41 ) , +1.50 - D executive bifocals ( n = 48 ) , and +1.50 - D executive bifocals with 3 - base-in prism in the near segment of each lens ( n = 46 ) .
METHODS	MAIN OUTCOMES AND MEASURES Myopia progression ( primary ) measured using an automated refractor following cycloplegia and increase in axial length ( secondary ) measured using ultrasonography at intervals of 6 months for 36 months .
METHODS	RESULTS Myopia progression over 3 years was an average ( SE ) of -2.06 ( 0.13 ) D for the single-vision lens group , -1.25 ( 0.10 ) D for the bifocal group , and -1.01 ( 0.13 ) D for the prismatic bifocal group .
METHODS	Axial length increased an average ( SE ) of 0.82 ( 0.05 ) mm , 0.57 ( 0.07 ) mm , and 0.54 ( 0.06 ) mm , respectively .
METHODS	The treatment effect of bifocals ( 0.81 D ) and prismatic bifocals ( 1.05 D ) was significant ( P < .001 ) .
METHODS	Both bifocal groups had less axial elongation ( 0.25 mm and 0.28 mm , respectively ) than the single-vision lens group ( P < .001 ) .
METHODS	For children with high lags of accommodation ( 1.01 D ) , the treatment effect of both bifocals and prismatic bifocals was similar ( 1.1 D ) ( P < .001 ) .
METHODS	For children with low lags ( < 1.01 D ) , the treatment effect of prismatic bifocals ( 0.99 D ) was greater than of bifocals ( 0.50 D ) ( P = .03 ) .
METHODS	The treatment effect of both bifocals and prismatic bifocals was independent of the near phoria status .
CONCLUSIONS	Bifocal spectacles can slow myopia progression in children with an annual progression rate of at least 0.50 D after 3 years .
CONCLUSIONS	These results suggest that prismatic bifocals are more effective for myopic children with low lags of accommodation .
CONCLUSIONS	TRIAL REGISTRATION clinicaltrials.gov Identifier : NCT00787579 .

###25008885
OBJECTIVE	To observe the clinical efficacy and safety of sildenafil in the treatment of high altitude heart disease associated with severe pulmonary arterial hypertension ( PAH ) in children .
METHODS	Fifty children ( aged 2 months to 2 years ) with high altitude heart disease associated with severe PAH , who were continuously transferred to the Intensive Care Unit between January 2011 and October 2013 , were randomly assigned to observation and control groups .
METHODS	The control group was given conventional treatment , while the observation group received oral sildenafil [ 1 mg / ( kg.d ) ] three times daily for 7-10 days in addition to the conventional treatment .
METHODS	Before and after treatment , hemodynamics , blood gas , routine blood parameters , and blood biochemical parameters were recorded .
RESULTS	After treatment , the observation group had a significantly higher decrease in mean pulmonary artery pressure and significantly higher increases in arterial partial pressure of oxygen , cardiac output , cardiac index , and oxygenation index compared with the control group ( P < 0.05 ) .
RESULTS	In the observation group , there were no significant changes in mean arterial pressure , routine blood parameters and blood biochemical parameters ( P > 0.05 ) , and no obvious adverse reactions were found .
CONCLUSIONS	For children with high altitude heart disease associated with severe PAH , sildenafil can effectively reduce pulmonary artery pressure and improve cardiac function and does not cause adverse reactions .
CONCLUSIONS	This therapy has good safety according to the preliminary evaluation .

###24284309
BACKGROUND	Surgical plethysmographic index ( SPI ) has been proposed as a tool to measure the nociception/antinociception balance during general anaesthesia .
BACKGROUND	Untreated nociception may increase sympathetic tone , but the relationship between SPI and the autonomic nervous system ( ANS ) is poorly understood .
OBJECTIVE	We hypothesised that two different levels of SPI might be associated with differences in ANS modulation , measured by the frequency domain analysis of heart rate variability ( HRV ) .
METHODS	A randomised , cross-over group study , conducted between February and November 2009 .
METHODS	University tertiary referral hospital in Milan , Italy .
METHODS	Forty-two adult patients undergoing scheduled laparoscopic abdominal surgery .
METHODS	ECG , noninvasive arterial blood pressure and SPI were recorded during balanced general anaesthesia with inhaled sevoflurane and intravenous remifentanil .
METHODS	After pneumoperitoneum induction , the remifentanil infusion rate was set to obtain two different levels of SPI ( > 50 , HI-SPI , and < 50 , LO-SPI ) for each patient .
METHODS	Arterial pressure , heart rate ( HR ) , low-frequency and high-frequency spectral components , the low frequency/high frequency ratio ( measure of sympathovagal balance ) and whole power spectrum density of HRV were measured at the two different levels of SPI .
RESULTS	Thirty-nine patients were included in the final analysis .
RESULTS	During LO-SPI , HR and systolic and mean blood pressures were significantly lower than HI-SPI .
RESULTS	The median low frequency/high frequency ratio was reduced during LO-SPI [ 1.29 interquartile range ( IQR ) 0.66 to 2.05 ) vs. 2.36 ( 1.30 to 3.62 ) , P = 0.008 ] .
RESULTS	The sensitivity analysis revealed a significant correlation between SPI changes and changes of all ANS indices , arterial pressure and HR , with a slightly better correlation for low frequency/high frequency ( Spearman = 0.70 , IQR 0.484 to 0.834 , P < 0.001 ) .
CONCLUSIONS	In the context of a balanced general anaesthesia in healthy patients undergoing laparoscopic abdominal surgery , ANS modulation seems to correlate with changes in SPI .
CONCLUSIONS	Further studies are warranted to assess whether this may reflect a change in nociception/antinociception balance or a pharmacodynamic effect of remifentanil .

###25053182
BACKGROUND	We evaluated the effects of a levosimendan ( LS ) - based strategy compared with standard inotropic therapy on renal function in heart transplantation .
RESULTS	Using a randomized study design , 94 patients were assigned to LS-based therapy or standard inotropic support .
RESULTS	At the time of transplantation , the groups did not differ in age , gender , heart failure etiology , hemodynamic profile , LVEF , or comorbidities .
RESULTS	While there were no differences in serum creatinine ( sCr ) or eGFR between groups at baseline , patients in the LS group had a greater increase in their relative eGFR ( 62 % vs. 12 % , p = 0.002 ) and a lower incidence of acute kidney injury ( AKI ) ( 28 % vs. 6 % , p = 0.01 ) during the first post-transplant week .
RESULTS	On logistic regression analysis , correlates of AKI were randomization to LS therapy ( OR = 0.21 [ 0.09-0 .62 ] , p = 0.01 ) , baseline renal dysfunction ( OR = 3.9 [ 1.1-13 .6 ] , p = 0.032 ) , and diabetes mellitus ( OR = 4.2 [ 1.1-16 .5 ] , p = 0.038 ) .
RESULTS	However , LS was associated with a greater need for additional norepinephrine therapy ( 40 [ 85 % ] vs. 15 [ 31 % ] , p < 0.001 ) and a trend toward longer intensive care unit stay ( 9.59.0 d vs. 7.06.0 d , p = 0.13 ) .
CONCLUSIONS	In patients undergoing heart transplantation , levosimendan-based strategy may be associated with better renal function when compared to standard therapy .

###24835247
BACKGROUND	After measles vaccine ( MV ) , all-cause mortality is reduced more than can be explained by the prevention of measles , especially in females .
OBJECTIVE	We aimed to study the biological mechanisms underlying the observed non-specific and sex-differential effects of MV on mortality .
METHODS	Within a large randomised trial of MV at 4.5 months of age blood samples were obtained before and six weeks after randomisation to early MV or no early MV .
METHODS	We measured concentrations of cytokines and soluble receptors from plasma ( interleukin-1 receptor agonist ( IL-1Ra ) , IL-6 , IL-8 , IL-10 , tumor necrosis factor ( TNF ) - , monocyte chemoattractant protein ( MCP ) -1 , soluble urokinase-type plasminogen activator receptor ) , and secreted cytokines ( interferon - , TNF - , IL-5 , IL-10 , IL-13 , IL-17 ) after in vitro challenge with innate agonists and recall antigens .
METHODS	We analysed the effect of MV in multiple imputation regression , overall and stratified by sex .
METHODS	The majority of the infants had previously been enrolled in a randomised trial of neonatal vitamin A. Post hoc we explored the potential effect modification by neonatal vitamin A.
RESULTS	Overall , MV versus no MV was associated with higher plasma MCP-1 levels , but the effect was only significant among females .
RESULTS	Additionally , MV was associated with increased plasma IL-1Ra .
RESULTS	MV had significantly positive effects on plasma IL-1Ra and IL-8 levels in females , but not in males .
RESULTS	These effects were strongest in vitamin A supplemented infants .
RESULTS	Vitamin A shifted the effect of MV in a pro-inflammatory direction .
CONCLUSIONS	In this explorative study we found indications of sex-differential effects of MV on several of the plasma biomarkers investigated ; in particular MV increased levels in females , most strongly in vitamin A recipients .
CONCLUSIONS	The findings support that sex and micronutrient supplementation should be taken into account when analysing vaccine effects .
BACKGROUND	clinicaltrials.gov number NCT 00168545 .

###24826894
BACKGROUND	This cost analysis uses data from a randomized trial comparing a noprophylaxis versus prophylactic platelet ( PLT ) transfusion policy ( counts < 1010 ( 9 ) / L ) in adult patients with hematologic malignancies .
BACKGROUND	Results are presented for all patients and separately for autologous hematopoietic stem cell transplantation ( HSCT ) ( autoHSCT ) and chemotherapy/allogeneic HSCT ( chemo/alloHSCT ) patients .
METHODS	Data were collected to 30 days on PLT and red blood cell ( RBC ) transfusions , major bleeds , serious adverse events , critical care , and hematology ward stay .
METHODS	Data were costed using 2011 to 2012 UK unit costs and converted into US$ .
METHODS	Sensitivity analyses were performed on uncertain cost variables .
RESULTS	Across the whole trial no prophylaxis saved costs compared to prophylaxis : - $ 1760 per patient ( 95 % confidence interval [ CI ] , - $ 3250 to - $ 249 ; p < 0.05 ) .
RESULTS	For autoHSCT patients there was no cost difference between arms : - $ 110 per patient ( 95 % CI , - $ 1648 to $ 1565 ; p = 0.89 ) .
RESULTS	For chemo/alloHSCT patients noprophylaxis cost significantly less than prophylaxis : - $ 5686 per patient ( 95 % CI , - $ 8580 to - $ 2853 ; p < 0.01 ) .
RESULTS	The cost impact of noprophylaxis differed significantly between subgroups .
RESULTS	Sensitivity analyses varying daily treatment costs and ward stay for chemo/alloHSCT patients reduced cost differences to - $ 941 per patient ( p = 0.21 ) across the whole trial and - $ 2927 per patient ( p < 0.05 ) in chemo/alloHSCT subgroup .
CONCLUSIONS	It is unclear whether a no-prophylaxis policy saves costs overall .
CONCLUSIONS	In chemo/alloHSCT patients cost savings are apparent but their magnitude is sensitive to a number of variables and must be considered alongside clinical data showing increased bleeding rates .
CONCLUSIONS	In autoHSCT patients savings generated through lower PLT use in no-prophylaxis arm were offset by cost increases elsewhere , for example , additional RBC transfusions .
CONCLUSIONS	Cost-effectiveness analyses of alternative PLT transfusion policies simultaneously considering costs and patient-reported outcomes are warranted .

###24590961
BACKGROUND	After the fall of the Taliban regime , most clinics in Afghanistan were charging fees to patients .
BACKGROUND	The government invested in monitoring and evaluation systems for its newly rebuilt primary care system , but little was known about the effects of user fees .
BACKGROUND	This study was undertaken to provide evidence on user fees ' effects on quality and service utilization and to help inform development of health financing policy and strategy .
METHODS	A quasi-experimental health financing pilot study was implemented in 2005 .
METHODS	Forty-seven facilities were randomized to implement a standardized user fee intervention , offer free services , or serve as controls , continuing current cost-sharing systems .
METHODS	Revenues were co-managed by staff and community leaders for facility improvement .
METHODS	Baseline and follow-up facility assessments , exit interviews , and household surveys , as well as routine data were used to evaluate user fee effects over 2years .
RESULTS	Observed and perceived quality improved at most facilities but did not differ by study group .
RESULTS	Utilization increased in all groups , but the increase was 682 to 748 visits per month larger in facilities randomized to free services compared with those randomized to fees or controls ( p < 0.01 ) .
CONCLUSIONS	User fees demonstrated few beneficial effects and slowed the rate of increase of service utilization in Afghanistan .
CONCLUSIONS	In 2008 , the government abolished primary care fees , citing results of this study .

###25292072
OBJECTIVE	To explore the influence of different ways of blood transfusion on the expression levels of interleukins ( IL ) and tumor necrosis factor - ( TNF - ) inperi-operative patients with esophageal cancer .
METHODS	A total of 80 patients with esophageal cancer who underwent radical operations were selected as study patients and randomly divided into an observation group ( treated with autologous blood transfusion ) and control group ( with homologous blood transfusion ) .
METHODS	Changes of intra-operative indexes and peri-operative blood indexes , from hemoglobin ( Hb ) and hematocrit value ( Hct ) , to levels of inflammatory factors like interleukins-6 ( IL-6 ) , IL-8 , IL-10 and tumor necrosis factor - ( TNF - ) were compared .
RESULTS	Operations for patients in both groups were successfully conducted , and no significant differences in mean surgical duration and intra-operative hemorrhage volume , fluid infusion volume and blood transfusion volume were detected ( p > 0.05 ) .
RESULTS	Compared with values before surgery , Hb and Hct levels decreased significantly while white blood cell count ( WBC ) increased 1 , 5 and 7 d after operation ( p < 0.05 , p < 0.01 ) .
RESULTS	In addition , WBC was apparently higher in observation group than in control group 5 and 7 d after operation ( p < 0.01 ) .
RESULTS	Compared with before surgery , in the observation group , levels of IL-6 , IL-8 and IL-10 had no significant differences after operation ( P > 0.05 ) , but TNF - level increased y ( p < 0.01 ) , whereas in control group , IL-6 level had no significant difference ( p > 0.05 ) , IL-8 level decreased obviously ( p < 0.05 ) , IL-10 level increased markedly first and then decreased gradually as time passed but its level remained elevated ( p < 0.01 ) , and TNF - level increased first and then decreased , and there was no significant difference 7 d after operation ( p > 0.05 ) .
CONCLUSIONS	Decreased IL-8 and increased IL-10 levels are two important reasons forimmunosuppression after homologous blood transfusion , whereas autologous blood transfusion can alleviate this while increasing the TNF - level , which also has potential to improve anti-tumor immunity in the human body .

###25509726
OBJECTIVE	To observe the improvements of synchronous treatment of bilateral scalp acupuncture and rehabilitation training on activities of daily life in patients with cerebral infarction at acute phase , so as to compare the efficacy differences between scalp acupuncture at bilateral and affected side as well as differences between synchronous and non-synchronous treatment .
METHODS	Ninety patients of acute-phase cerebral infarction with motor dysfunction were randomly divided into three groups .
METHODS	The observation group was treated with synchronous treatment of scalp acupuncture at the Dingzhongxian ( middle line of vertex ) , bilateral Dingnieqianxiexian ( anterior oblique line of vertex-temporal ) and bilateral Dingniehouxiexian ( posterior oblique line of vertex-temporal ) and rehabilitation training ; the control group A was treated with synchronous treatment of affected scalp acupuncture at the Dingzhongxian , affected Dingnieqianxiexian and affected Dingniehouxiexian and rehabilitation training ; the control group B was treated with bilateral scalp acupuncture for 4 h , followed by rehabilitation training .
METHODS	All the patients took the treatment once a day , and 6 days for a course of treatment for total of 4 courses .
METHODS	The modified Barthel index ( MBI ) , activities of daily living ( ADL ) and Fugl-Meyer motor assessment ( FMA ) were used to perform efficacy assessment before treatment , in the 14th days of treatment and in the 28th days of treatment in three groups .
RESULTS	After treatment , three indices at each time point were superior to those before the treatment in three groups ( all P < 0.01 ) ; the improvements of ADL and FMA in the observation group after 28 days of treatment were superior to those in the control group A and control group B ( all P < 0.05 ) , and the improvement of MBI was superior to that in the control group B ( P < 0.05 ) .
CONCLUSIONS	The synchronous treatment of bilateral scalp acupuncture and rehabilitation training could significantly improve the activities of daily life and motor function in patients with cerebral infarction at acute phase , which is superior to scalp acupuncture at affected side and non-synchronous treatment .

###24648103
BACKGROUND	Clinical prediction rules can assist clinicians to identify patients with low back pain ( LBP ) who are likely to recover quickly with minimal treatment ; however , there is a paucity of validated instruments to assist with this task .
METHODS	We performed a pre-planned external validation study to assess the generalizability of a simple 3-item clinical prediction rule developed to estimate the probability of recovery from acute LBP at certain time points .
METHODS	The accuracy of the rule ( calibration and discrimination ) was determined in a sample of 956 participants enrolled in a randomized controlled trial .
RESULTS	The calibration of the rule was reasonable in the new sample with predictions of recovery typically within 5-10 % of observed recovery .
RESULTS	Discriminative performance of the rule was poor to moderate and similar to that found in the development sample .
CONCLUSIONS	The results suggest that the rule can be used to provide accurate information about expected recovery from acute LBP , within the first few weeks of patients presenting to primary care .
CONCLUSIONS	Impact analysis to determine if the rule influences clinical behaviours and patient outcomes is required .

###24646034
BACKGROUND	Multidrug-resistant organisms ( MDRO ) are the dominant airway pathogens in the intensive care unit ( ICU ) and present a major treatment challenge to intensivists .
BACKGROUND	Aerosolized antibiotics ( AA ) result in airway concentrations of drug 100-fold greater than the minimal inhibitory concentration of most bacteria including MDRO .
BACKGROUND	These levels , without systemic toxicity , may eradicate MDRO and reduce the pressure for selection of new resistant organisms .
OBJECTIVE	To determine if AA effectively eradicate MDRO in the intubated patient without promoting new resistance .
METHODS	In a double-blind placebo-controlled study , critically ill intubated patients were randomized if they exhibited signs of respiratory infection ( purulent secretions and Clinical Pulmonary Infection Score 6 ) .
METHODS	Using a well-characterized aerosol delivery system , AA or saline placebo was given for 14 days or until extubation .
METHODS	The responsible clinician determined administration of systemic antibiotics for ventilator-associated pneumonia and any other infection .
RESULTS	AA eradicated 26 of 27 organisms present at randomization compared with 2 of 23 organisms with placebo ( P < 0.0001 ) .
RESULTS	AA eradicated the original resistant organism on culture and Gram stain at end of treatment in 14 out of 16 patients compared with 1 of 11 for placebo ( P < 0.001 ) .
RESULTS	New drug resistance to AA was not seen .
RESULTS	Compared with AA , resistance to systemic antibiotics significantly increased in placebo patients ( P = 0.03 ) .
RESULTS	Compared with placebo , AA significantly reduced Clinical Pulmonary Infection Score ( mean SEM , 9.3 2.7 to 5.3 2.6 vs. 8.0 23 to 8.6 2.10 ; P = 0.0008 ) .
CONCLUSIONS	In chronically intubated critically ill patients , AA successfully eradicated existing MDRO organisms and reduced the pressure from systemic agents for new respiratory resistance .
CONCLUSIONS	Clinical trial registered with www.clinicaltrials.gov ( NCT 01878643 ) .

###25062806
OBJECTIVE	To explore the feasibility and cost effectiveness of screening and delivery of a brief intervention for hazardous drinking employees .
METHODS	A pilot randomised controlled trial of a brief intervention delivered by an Occupational Health nurse versus no delivery of brief intervention ( control group ) conducted in a Local Authority Council ( LCA ) in the United Kingdom .
METHODS	Changes in quality of life and economic indicators were measured by the EQ-5D .
RESULTS	627 employees were screened of whom 163 ( 26.01 % ) fulfilled the inclusion criteria with a total of 57 ( 35 % ) agreeing to participate .
RESULTS	No significant differences were found between the groups for baseline demographics or levels/patterns of alcohol consumption .
RESULTS	A statistically significant effect was found in the mean AUDIT scores over time ( F = 8.96 , p = 0.004 ) but not for group ( F = 0.017 , p = 0.896 ) , and no significant interaction was found ( F = 0.148 , p = 0.702 ) .
RESULTS	The cost of each intervention was calculated at 12.48 , the difference in service costs was calculated at 344.50 per person ; that is there was a net saving of health and other care costs in the intervention group compared to the control group .
RESULTS	The QALYs fell in both intervention and control groups , the difference -0.002 - ( -0.010 ) yields a net advantage of the intervention of 0.008 QALYs .
CONCLUSIONS	The main results from this pilot study suggest that alcohol brief interventions delivered in the workplace may offer the potential to reduce alcohol-related harm and save public sector resources .
CONCLUSIONS	A fully powered multi-centre trial is warranted to contribute to the current evidence base and explore further the potential of alcohol brief interventions in the workplace .
CONCLUSIONS	In a full trial the recruitment method may need to be re-considered .

###24961753
OBJECTIVE	We investigated the safety , tolerability , pharmacokinetics and pharmacodynamics of evacetrapib .
METHODS	Healthy volunteers received multiple daily doses of evacetrapib ( 10-600mg ) administered for up to 15 days in a placebo-controlled study .
RESULTS	Mean peak plasma concentrations of evacetrapib occurred at 4-6h and terminal half-life ranged 24-44h .
RESULTS	Steady state was achieved at approximately 10 days ; all subjects had undetectable levels of evacetrapib 3 weeks after their last dose .
RESULTS	The trough inhibition of cholesteryl ester transfer protein ( CETP ) activity was 65 and 84 % at 100 and 300mg , respectively .
RESULTS	At the highest dose ( 600mg ) , evacetrapib significantly inhibited CETP activity ( 91 % ) , increased HDL-C ( 87 % ) and apo AI ( 42 % ) , and decreased LDL-C ( 29 % ) and apo B ( 26 % ) relative to placebo .
RESULTS	For the highest dose tested , levels of evacetrapib , CETP activity , CETP mass , HDL-C and LDL-C returned to levels at or near baseline after a 2-week washout period .
RESULTS	Evacetrapib at the highest dose tested did not produce any significant effect on 24-h ambulatory systolic or diastolic blood pressure .
CONCLUSIONS	Multiple doses of evacetrapib potently inhibited CETP activity , leading to substantial elevations in HDL-C and lowering of LDL-C .
CONCLUSIONS	Evacetrapib was devoid of clinically relevant effects on blood pressure and mineralocorticoid levels .

###25155103
BACKGROUND	Clinical decision support ( CDS ) for primary care has been shown to improve delivery of preventive services .
BACKGROUND	However , there is little evidence for efficiency of physicians due to CDS assistance .
BACKGROUND	In this article , we report a pilot study for measuring the impact of CDS on the time spent by physicians for deciding on preventive services and chronic disease management .
METHODS	We randomly selected 30 patients from a primary care practice , and assigned them to 10 physicians .
METHODS	The physicians were requested to perform chart review to decide on preventive services and chronic disease management for the assigned patients .
METHODS	The patients assignment was done in a randomized crossover design , such that each patient received 2 sets of recommendations-one from a physician with CDS assistance and the other from a different physician without CDS assistance .
METHODS	We compared the physician recommendations made using CDS assistance , with the recommendations made without CDS assistance .
RESULTS	The physicians required an average of 1 minute 44 seconds , when they were they had access to the decision support system and 5 minutes when they were unassisted .
RESULTS	Hence the CDS assistance resulted in an estimated saving of 3 minutes 16 seconds ( 65 % ) of the physicians ' time , which was statistically significant ( P < .0001 ) .
RESULTS	There was no statistically significant difference in the number of recommendations .
CONCLUSIONS	Our findings suggest that CDS assistance significantly reduced the time spent by physicians for deciding on preventive services and chronic disease management .
CONCLUSIONS	The result needs to be confirmed by performing similar studies at other institutions .

###24508897
BACKGROUND	Tenofovir alafenamide ( formerly GS-7340 ) is a new oral prodrug of tenofovir , a nucleotide analogue that inhibits HIV-1 reverse transcription .
BACKGROUND	Unlike the currently marketed tenofovir prodrug , tenofovir disoproxil fumarate , tenofovir alafenamide is stable in plasma and then rapidly converted into tenofovir once inside cells .
METHODS	The pharmacokinetics , safety and antiviral activity of 40 or 120 mg of tenofovir alafenamide compared with 300 mg of tenofovir disoproxil fumarate when administered as monotherapy once daily for 14 days in HIV-1-infected , treatment-naive subjects was studied .
RESULTS	Administration of 40 mg of tenofovir alafenamide for 14 days resulted in lower tenofovir Cmax ( 13 versus 207 ng/mL ) and lower systemic exposures ( AUC0-t , 383 versus 1810 ngh/mL ) compared with subjects who received tenofovir disoproxil fumarate .
RESULTS	There were higher intracellular tenofovir concentrations within peripheral blood mononuclear cells with both 40 mg of tenofovir alafenamide ( 8.2 M ) and 120 mg of tenofovir alafenamide ( 16.9 M ) compared with 300 mg of tenofovir disoproxil fumarate ( 0.9 M ) .
RESULTS	The most commonly observed adverse events were headache , nausea and flatulence , which occurred similarly across the three groups .
RESULTS	After 14 days , the mean changes in HIV-1 RNA were -0.94 logcopies/mL for the tenofovir disoproxil fumarate group , -1.57 log copies/mL for the 40 mg of tenofovir alafenamide group and -1.71 log copies/mL for the 120 mg of tenofovir alafenamide group .
RESULTS	The mean first-phase HIV-1 RNA decay slopes were -0.36 , -0.63 and -0.64 for the tenofovir disoproxil fumarate group , the 40 mg of tenofovir alafenamide group and the 120 mg of tenofovir alafenamide group , respectively .
RESULTS	No resistance mutations to either tenofovir alafenamide or tenofovir disoproxil fumarate were detected .
CONCLUSIONS	Tenofovir alafenamide , a new once-daily oral prodrug of tenofovir , showed more potent anti-HIV-1 activity and higher intracellular tenofovir levels compared with tenofovir disoproxil fumarate , while maintaining lower plasma tenofovir exposure at 40 mg with good tolerability over 14 days of monotherapy .

###25141111
OBJECTIVE	To verify the incidence of facetary and low back pain after a controlled medial branch anesthetic block in a three-month follow-up and to verify the correlation between the positive results and the demographic variables .
METHODS	Patients with chronic lumbar pain underwent a sham blockade ( with a saline injection ) and then a controlled medial branch block .
METHODS	Their symptoms were evaluated before and after the sham injection and after the real controlled medial branch block ; the symptoms were reevaluated after one day and one week , as well as after one , two and three months using the visual analog scale .
METHODS	We searched for an association between the positive results and the demographic characteristics of the patients .
RESULTS	A total of 104 controlled medial branch blocks were performed and 54 patients ( 52 % ) demonstrated > 50 % improvements in pain after the blockade .
RESULTS	After three months , lumbar pain returned in only 18 individuals , with visual analogue scale scores > 4 .
RESULTS	Therefore , these patients were diagnosed with chronic facet low back pain .
RESULTS	The three-months of follow-up after the controlled medial branch block excluded 36 patients ( 67 % ) with false positive results .
RESULTS	The results of the controlled medial branch block were not correlated to sex , age , pain duration or work disability but were correlated with patient age ( p < 0.05 ) .
CONCLUSIONS	Patient diagnosis with a controlled medial branch block proved to be effective but was not associated with any demographic variables .
CONCLUSIONS	A three-month follow-up is required to avoid a high number of false positives .

###25417609
OBJECTIVE	To investigate the prevalence of malnutrition in patients with inflammatory bowel disease ( IBD ) by subjective global assessment ( SGA ) and the effects of oral nutritional support on the clinical parameters , consumption of energy , macronutrients and fiber intake in the Study and Control groups , prospectively .
METHODS	A total of 38 ( 28 Male ; 10 Female ) hospitalized patients with moderate or severe IBD ( 13 with Crohn 's disease ( CD ) ; 25 with Ulcerative colitis ( UC ) ) were included .
METHODS	At stage 1 , the disease severity , clinical symptoms and , signs , food consumption and nutritional status by using subjective global assessment ( SGA ) were recorded .
METHODS	At stage 2 , the patients were blindly randomized into a Study Group and Controls .
METHODS	In the Study Group , a standard enteral product was added into the regulated hospital diets , but for the Controls , deficits were regulated by only hospital diets for 3 weeks .
METHODS	the independent variables were the group , the disease and its activity , age , Body body mass index ( BMI ) , weight loss history , the hospitalization period ; the dependent variables were SGA , bowel movements , change in nutritional status , disease severity , clinical findings , and also consumption of macronutrients .
RESULTS	Prevalance of malnutrition ( SGA-B or SGA-C ) for all the patients was 92.1 % at the beginning and 71.1 % at the end of study .
RESULTS	Improvements in disease activity score for the patients with UC were statistically significant in both the Study Group and the Controls ( p = 0.006 for the Study Group and p = 0.001 for the Controls , respectively ) .
RESULTS	Macronutrients , total and water soluble fiber consumption levels improved , with statistically significant differences for all the groups .
CONCLUSIONS	The prevalence of malnutrition is a major problem in patients with IBD .
CONCLUSIONS	Not only the regulation of hospital food , but also enteral nutritional support , improved their levels of malnutrition , as well as their energy , macronutrients , and fiber consumption , and SGA is an easy method for nutritional monitoring .

###24690267
BACKGROUND	Stroke can result in death and long-term disability .
BACKGROUND	Fast and high-quality care can reduce the impact of stroke , but UK national audit data has demonstrated variability in compliance with recommended processes of care .
BACKGROUND	Though quality improvement collaboratives ( QICs ) are widely used , whether a QIC could improve reliability of stroke care was unknown .
METHODS	Twenty-four NHS hospitals in the Northwest of England were randomly allocated to participate either in Stroke 90:10 , a QIC based on the Breakthrough Series ( BTS ) model , or to a control group giving normal care .
METHODS	The QIC focused on nine processes of quality care for stroke already used in the national stroke audit .
METHODS	The nine processes were grouped into two distinct care bundles : one relating to early hours care and one relating to rehabilitation following stroke .
METHODS	Using an interrupted time series design and difference-in-difference analysis , we aimed to determine whether hospitals participating in the QIC improved more than the control group on bundle compliance .
RESULTS	Data were available from nine interventions ( 3,533 patients ) and nine control hospitals ( 3,059 patients ) .
RESULTS	Hospitals in the QIC showed a modest improvement from baseline in the odds of average compliance equivalent to a relative improvement of 10.9 % ( 95 % CI 1.3 % , 20.6 % ) in the Early Hours Bundle and 11.2 % ( 95 % CI 1.4 % , 21.5 % ) in the Rehabilitation Bundle .
RESULTS	Secondary analysis suggested that some specific processes were more sensitive to an intervention effect .
CONCLUSIONS	Some aspects of stroke care improved during the QIC , but the effects of the QIC were modest and further improvement is needed .
CONCLUSIONS	The extent to which a BTS QIC can improve quality of stroke care remains uncertain .
CONCLUSIONS	Some aspects of care may respond better to collaboratives than others .
BACKGROUND	ISRCTN13893902 .

###24332141
BACKGROUND	Tirofiban and eptifibatide are both small-molecule , competitive glycoprotein IIb/IIIa receptor inhibitors ( GPIs ) that are guideline-supported for upstream therapy in acute coronary syndromes ( ACS ) .
BACKGROUND	This study sought to compare the efficacy and safety of tirofiban and eptifibatide in patients with ACS .
METHODS	Within the ACUITY trial , 4,323 patients with moderate - and high-risk ACS received upstream , adjunctive GPI ( tirofiban or eptifibatide ) in addition to an antithrombin .
METHODS	Primary outcomes included 30-day rates of composite major adverse cardiac events ( MACE ) , major bleeding ( not related to coronary artery bypass grafting ) , and composite net adverse clinical events ( NACE ) .
METHODS	The outcomes were compared based on the upstream GPI administered .
RESULTS	There were significant differences in the baseline characteristics of patients treated with tirofiban vs eptifibatide , particularly related to country/region .
RESULTS	In unadjusted analyses , treatment with upstream tirofiban vs eptifibatide was associated with similar rates of major bleeding ( 5.8 % vs 6.5 % , P = .39 ) and nonsignificantly lower rates of MACE ( 6.1 % vs 7.6 % , P = .06 ) and NACE ( 10.6 % vs 12.6 % , P = .06 ) .
RESULTS	After propensity-based multivariable adjustment , there were no significant differences between tirofiban and eptifibatide with respect to 30-day major bleeding , MACE , or NACE .
CONCLUSIONS	Among more than 4,000 patients with moderate - and high-risk ACS treated with upstream GPI as part of an early invasive management strategy , the use of tirofiban and eptifibatide resulted in similar clinical outcomes .
CONCLUSIONS	These data suggest equivalence of these 2 agents for upstream use , while highlighting some of the difficulties of nonrandomized comparative effectiveness analyses , specifically the difficulty in addressing geographic differences in the use of nonrandomized treatments .

###25168020
BACKGROUND	There has been no comparison of detectability of small lung cancer between general and medical LCD monitors or no comparison of detectability of small lung cancer between solid and part-solid nodules .
OBJECTIVE	To compare the detectabilities of T1a lung cancer on chest radiographs on three LCD monitor types : 2-megapixel ( MP ) for general purpose ( General ) , 2-MP for medical purpose ( Medical ) , and 3-MP-Medical .
METHODS	Radiographs from forty patients with T1aN0M0 primary lung cancer ( 27 solid nodules , 13 part-solid nodules ) and 60 patients with no abnormalities on both chest X-ray and computed tomography ( CT ) were consecutively collected .
METHODS	Five readers assessed 100 cases for each monitor .
METHODS	The observations were analyzed using receiver operating characteristic ( ROC ) analysis .
METHODS	A jackknife method was used for statistical analysis .
METHODS	A P value of < 0.05 was considered significant .
RESULTS	The average AUC for all T1a lung cancer nodule detection using the 2-MP-General , 2-MP-Medical , and 3-MP-Medical LCD monitors were 0.86 , 0.89 , and 0.89 , respectively ; there were no significant differences among them .
RESULTS	The average AUC for part-solid nodule detection using a 2-MP-General , 2-MP-Medical , and 3-MP-Medical LCD monitors were 0.77 , 0.86 , and 0.89 , respectively .
RESULTS	There were significant differences between the 2-MP-General and 2-MP-Medical LCD monitors ( P = 0.043 ) and between the 2-MP-General and 3-MP-Medical LCD monitors ( P = 0.027 ) .
RESULTS	There was no significant difference between the 2-MP-Medical and 3-MP-Medical LCD monitors .
RESULTS	The average AUC for solid nodule detection using a 2-MP-General , 2-MP-Medical , and 3-MP-Medical LCD monitors were 0.90 , 0.90 , and 0.88 , respectively ; there were no significant differences among them .
RESULTS	The mean AUC values for all and part-solid nodules of the low-experienced readers were significantly lower than those of the high-experienced readers with the 2 M-GP color LCD monitor ( P < 0.05 ) .
CONCLUSIONS	Detectability of part-solid nodules using a general-purpose LCD monitor was significantly lower than those using medical-purpose LCD monitors .

###26156323
OBJECTIVE	To test whether community mobilization adds effectiveness to conventional dengue control .
METHODS	Pragmatic open label parallel group cluster randomized controlled trial .
METHODS	Those assessing the outcomes and analyzing the data were blinded to group assignment .
METHODS	Centralized computerized randomization after the baseline study allocated half the sites to intervention , stratified by country , evidence of recent dengue virus infection in children aged 3-9 , and vector indices .
METHODS	Random sample of communities in Managua , capital of Nicaragua , and three coastal regions in Guerrero State in the south of Mexico .
METHODS	Residents in a random sample of census enumeration areas across both countries : 75 intervention and 75 control clusters ( about 140 households each ) were randomized and analyzed ( 60 clusters in Nicaragua and 90 in Mexico ) , including 85,182 residents in 18,838 households .
METHODS	A community mobilization protocol began with community discussion of baseline results .
METHODS	Each intervention cluster adapted the basic intervention-chemical-free prevention of mosquito reproduction-to its own circumstances .
METHODS	All clusters continued the government run dengue control program .
METHODS	Primary outcomes per protocol were self reported cases of dengue , serological evidence of recent dengue virus infection , and conventional entomological indices ( house index : households with larvae or pupae/households examined ; container index : containers with larvae or pupae/containers examined ; Breteau index : containers with larvae or pupae/households examined ; and pupae per person : pupae found/number of residents ) .
METHODS	Per protocol secondary analysis examined the effect of Camino Verde in the context of temephos use .
RESULTS	With cluster as the unit of analysis , serological evidence from intervention sites showed a lower risk of infection with dengue virus in children ( relative risk reduction 29.5 % , 95 % confidence interval 3.8 % to 55.3 % ) , fewer reports of dengue illness ( 24.7 % , 1.8 % to 51.2 % ) , fewer houses with larvae or pupae among houses visited ( house index ) ( 44.1 % , 13.6 % to 74.7 % ) , fewer containers with larvae or pupae among containers examined ( container index ) ( 36.7 % , 24.5 % to 44.8 % ) , fewer containers with larvae or pupae among houses visited ( Breteau index ) ( 35.1 % , 16.7 % to 55.5 % ) , and fewer pupae per person ( 51.7 % , 36.2 % to 76.1 % ) .
RESULTS	The numbers needed to treat were 30 ( 95 % confidence interval 20 to 59 ) for a lower risk of infection in children , 71 ( 48 to 143 ) for fewer reports of dengue illness , 17 ( 14 to 20 ) for the house index , 37 ( 35 to 67 ) for the container index , 10 ( 6 to 29 ) for the Breteau index , and 12 ( 7 to 31 ) for fewer pupae per person .
RESULTS	Secondary per protocol analysis showed no serological evidence of a protective effect of temephos .
CONCLUSIONS	Evidence based community mobilization can add effectiveness to dengue vector control .
CONCLUSIONS	Each site implementing the intervention in its own way has the advantage of local customization and strong community engagement .
BACKGROUND	ISRCTN27581154 .

###25338776
BACKGROUND	Traditionally , the therapeutic effect of antidepressants is thought to take several weeks .
BACKGROUND	However , several studies found evidence of early drug response occurring within the first 2weeks of antidepressant treatment and that this early onset response may predict eventual treatment outcome .
OBJECTIVE	This study aims to investigate the predictive value of early improvement in the course of treatment with imipramine or venlafaxine in an inpatient population with severe major depression .
METHODS	A post hoc analysis was conducted after pooling data from two almost identical trials .
METHODS	The study included 149 patients with DSM-IV diagnosis major depression and a baseline score 17 on the 17-item Hamilton Rating Scale for Depression ( HAM-D ) .
METHODS	Patients were randomized for double-blind treatment with either antidepressant .
METHODS	Early improvement ( 25 % reduction on HAM-D score ) was evaluated after 2weeks and response ( 50 % reduction on HAM-D score ) after 6weeks of acute treatment .
RESULTS	Of 64 patients achieving early improvement , 38 ( 59 % ) became responders , whereas of 85 patients not achieving early improvement , only 23 ( 27 % ) became responders .
RESULTS	There was a significant difference in time to response between patients achieving early improvement and patients not achieving early improvement .
RESULTS	Early improvement is a modest sensitive predictor for eventual response .
CONCLUSIONS	In the present study , although the sensitivity of early improvement was modest , based on the severity of clinical symptoms , a clinician treating a patient with severe major depression may seriously consider changing the treatment at an earlier stage than is presently customary .

###25189490
OBJECTIVE	Our objective was to investigate the actual incidence and clinical determinants of cough leading to discontinuation of ACE-inhibitors .
OBJECTIVE	Cough is the most frequent reason to stop ACE-inhibitor treatment .
METHODS	We studied 27,492 ACE-inhibitor nave patients randomized to the ACE-inhibitor perindopril or placebo using individual data of 3 clinical trials .
METHODS	Multivariate logistic regression analysis was used to study the incidence of cough in relation to baseline clinical characteristics including racial background .
RESULTS	In 27,492 patients with cardiovascular disease , 1076 patients discontinued ACE-inhibitor perindopril due to cough ( 3.9 % ) , 703 patients during run-in period of 4 weeks and 373 patients during a mean four years of follow-up .
RESULTS	Significant determinants of cough were female gender ( OR 1.92 95 % CI 1.68-2 .18 ) , age above 65 years ( OR 1.53 95 % CI 1.35-1 .73 ) , and concomitant use of lipid-lowering agents ( OR 1.37 ; 95 % CI 1.18-1 .59 ) .
RESULTS	A simple clinical risk score composed of these 3 predictors of cough mounted to an odds ratio of 4.4 ( 95 % CI 3.1-5 .4 ) in the subjects with highest score ( i.e. all determinants present ) .
RESULTS	Racial background was not related to a differential incidence of cough in patients of Caucasian or Asian descendent ( OR 1.11 95 % CI 0.92-1 .39 ) .
CONCLUSIONS	This large combined analysis of randomized clinical trials in 27,492 patients showed an overall lower incidence of cough leading to discontinuation of ACE-inhibitors ( 3.9 % ) as compared to literature .
CONCLUSIONS	Clinical determinants of such cough are older age , female gender and concomitant use of lipid-lowering agents .
CONCLUSIONS	In contrast , racial differences were not related to the incidence of cough .

###24670828
OBJECTIVE	The aim of the present paper was to make a report of the 12-month clinical outcomes of the DEBELLUM ( Drug-Eluting-Balloon-Evaluation-for-Lower-Limb - mUltilevel-treatMent ) randomized trial .
METHODS	From September 2010 to March 2011 , 50 patients were randomized between drug eluting balloon ( DEB , N. = 25 ) and conventional angioplasty balloon ( PTA , N. = 25 ) .
METHODS	Patients were symptomatic for claudication and critical limb ischemia , with de novo stenosis or occlusion in the femoropopliteal ( SFA ) and infrapopliteal ( BTK ) region .
METHODS	Only in the SFA primary stenting was allowed and postdilatation performed with DEB or PTA depending on the assigned group .
RESULTS	One hundred and twenty-two lesions were treated : 92 ( 75.4 % ) SFA , 30 ( 24.6 % ) BTK .
RESULTS	Twenty ( 40 % ) patients presented multilevel concomitant femoropopliteal and infra-popliteal lesions .
RESULTS	Late lumen loss ( LLL ) was 0.640.9 mm in DEB group vs. 1.810.1 mm in the control group ( P = 0.01 ) .
RESULTS	In non-stented segment LLL was 0.630.9 mm ( DEB ) vs. 1.700.6 mm ( PTA ) , P < 0.01 .
RESULTS	In the stent subgroup was LLL 0.650.2 mm ( DEB ) vs. 1.910.3 mm ( PTA ) , P < 0.01 .
RESULTS	In the femoropopliteal region the overall LLL was 0.610.8 mm for DEB vs. 1.840.3 mm for PTA ( P = 0.02 ) .
RESULTS	BTK the overall LLL was 0.660.9 mm ( DEB ) vs. 1.690.5 mm ( PTA ) ( P = 0.03 ) .
RESULTS	The overall TLR was 12.2 % for DEB and 35.3 % for PTA ( P < 0.05 ) .
RESULTS	Amputation rate was 4 % ( DEB ) vs. 12 % ( PTA ) , P = 0.36 .
RESULTS	Thrombosis was 4 % ( DEB ) vs. 8 % ( PTA ) , P0 .05 .
RESULTS	Major adverse events 24 % ( DEB ) vs. 60 % ( PTA ) , P < 0.05 .
RESULTS	ABI improved more in the DEB group : 0.810.3 vs. 0.680.13 ( P = 0.02 ) .
RESULTS	Fontaine stage increased ( from II b to I ) 80 % DEB vs. 56 % PTA ( P < 0.05 ) .
CONCLUSIONS	Results confirm and reinforce initial 6-month outcomes .
CONCLUSIONS	In.Pact DEB balloons can be considered efficient to reduce restenosis rate .

###24954343
OBJECTIVE	The aim of this study was to evaluate the effects of perioperative psychological and music interventions in elderly patients undergoing elective surgery on anxiety , post-operative pain , and changes in heart rate variability ( HRV ) to ascertain if perioperative psychological and music interventions can affect overall anxiety levels .
METHODS	Fourty elderly patients undergoing elective surgery were randomized to two groups ; one group received psychological and music intervention , and the other was the control .
METHODS	The intervention group underwent psychological intervention and listening to music for 30 min before surgery .
RESULTS	The mean change in HRV as determined by low frequency ( LF ) power measurements .
RESULTS	After the intervention , the ratio of mean LF to high frequency ( HF ) power decreased significantly in the intervention group compared to before the intervention ( p < 0.05 ) .
RESULTS	In the control group , mean LF measurements and the ratio of LF : HF did not change significantly .
RESULTS	In the intervention group , mean HF power was significantly higher after the procedure than before ( p < 0.01 ) .
RESULTS	Moreover , the mean self-rating anxiety score of the intervention group decreased after the procedure compared to before ( p < 0.05 ) .
RESULTS	The mean visual analogue score of the intervention group 6 hours after surgery was significantly lower than that of the control group ( p < 0.01 ) .
CONCLUSIONS	Perioperative psychological and music interventions can reduce anxiety and postoperative pain in elderly patients .

###24607594
BACKGROUND	The primary aim of the present study was to evaluate the short - and longer-term effects of a cycle training on children 's cycling skills .
BACKGROUND	A second aim of the study was to examine the effects of a cycle training , with and without parental involvement , on levels of cycling to school and on parental attitudes towards cycling .
METHODS	Three participating schools were randomly assigned to the `` intervention '' ( 25 children ) , the `` intervention plus parent '' ( 34 children ) or `` control '' condition ( 35 children ) .
METHODS	A cycle training ( four sessions of 45 min ) took place only in the intervention schools .
METHODS	Parents in the `` intervention plus parent '' condition were asked to assist their child in completing weekly homework tasks .
METHODS	Children 's cycling skills were assessed , using a practical cycling test .
METHODS	All participating children also received a short parental questionnaire on cycling behavior and parental attitudes towards cycling .
METHODS	Assessments took place at baseline , within 1 week after the last session and at 5-months follow-up .
METHODS	Repeated measure analyses were conducted to evaluate the effects of the cycle training .
RESULTS	Children 's total cycling skill score increased significantly more from pre to post and from pre to 5-months follow-up in the intervention group than in the control group .
RESULTS	On walking with the bicycle ( F = 1.6 ) , cycling in a straight line ( F = 2.6 ) , cycling a slalom ( F = 1.9 ) , cycling over obstacles ( F = 2.1 ) , cycling on a sloping surface ( F = 1.7 ) and dismounting the bicycle ( F = 2.0 ) , the cycle training had no effect .
RESULTS	For all other cycling skills , significant improvements were observed on short - and longer-term .
RESULTS	No significant intervention effects were found on children 's cycling to school levels ( F = 1.9 ) and parental attitudes towards cycling .
CONCLUSIONS	The cycle training course was effective in improving children 's cycling skills and the improvements were maintained 5 months later .
CONCLUSIONS	However , the cycle training course was not effective in increasing children 's cycling to school levels .

###25495503
OBJECTIVE	This study aims to investigate the influence of dietary education in patients with gout on a stable dose of urate-lowering therapy ( ULT ) .
METHODS	Males and females aged > 18 years with a history of gout , receiving an appropriate and stable dose of ULT , were recruited from two tertiary hospitals and randomised into two groups .
METHODS	The control group received basic advice regarding the importance of compliance with therapy and the benefit of weight loss .
METHODS	The intervention group received comprehensive dietary advice based on the British Society of Rheumatology Guidelines .
METHODS	Both groups received education at baseline and 3 months .
METHODS	Serum urate was measured at baseline , 3 months and 6 months , and a questionnaire was completed at baseline and at 6 months .
METHODS	The primary outcome of the study was to compare the change in serum urate between groups .
RESULTS	Thirty patients were recruited into the study .
RESULTS	There was no difference in serum urate between the control and intervention group at 6 months ( 0.29 mmol/L vs 0.29 mmol/L at baseline and 0.27 mmol/L vs 0.30 mmol/L at 6 months ) .
RESULTS	The intervention group showed a statistically significant improvement in knowledge ( 8/13 in control group at baseline to 9/13 at 6 months vs 8/13 in intervention group at baseline to 12/13 at 6 months , P < 0.05 ) and self-reported dietary modification ( 1 in control vs 7 in intervention P < 0.05 ) at 6 months .
CONCLUSIONS	This randomised controlled trial shows that in patients on ULT , providing education on diet does not lead to any clinically significant difference in serum urate at 6 months .

###25401325
OBJECTIVE	Prevention of atherosclerotic cardiovascular diseases is an important public health priority in Japan due to an aging population .
OBJECTIVE	To determine whether daily , low-dose aspirin reduces the incidence of cardiovascular events in older Japanese patients with multiple atherosclerotic risk factors .
METHODS	The Japanese Primary Prevention Project ( JPPP ) was a multicenter , open-label , randomized , parallel-group trial .
METHODS	Patients ( N = 14,464 ) were aged 60 to 85 years , presenting with hypertension , dyslipidemia , or diabetes mellitus recruited by primary care physicians at 1007 clinics in Japan between March 2005 and June 2007 , and were followed up for up to 6.5 years , with last follow-up in May 2012 .
METHODS	A multidisciplinary expert panel ( blinded to treatment assignments ) adjudicated study outcomes .
METHODS	Patients were randomized 1:1 to enteric-coated aspirin 100 mg/d or no aspirin in addition to ongoing medications .
METHODS	Composite primary outcome was death from cardiovascular causes ( myocardial infarction , stroke , and other cardiovascular causes ) , nonfatal stroke ( ischemic or hemorrhagic , including undefined cerebrovascular events ) , and nonfatal myocardial infarction .
METHODS	Secondary outcomes included individual end points .
RESULTS	The study was terminated early by the data monitoring committee after a median follow-up of 5.02 years ( interquartile range , 4.55-5 .33 ) based on likely futility .
RESULTS	In both the aspirin and no aspirin groups , 56 fatal events occurred .
RESULTS	Patients with an occurrence of nonfatal stroke totaled 114 in the aspirin group and 108 in the no aspirin group ; of nonfatal myocardial infarction , 20 in the aspirin group and 38 in the no aspirin group ; of undefined cerebrovascular events , 3 in the aspirin group and 5 in the no aspirin group .
RESULTS	The 5-year cumulative primary outcome event rate was not significantly different between the groups ( 2.77 % [ 95 % CI , 2.40 % -3.20 % ] for aspirin vs 2.96 % [ 95 % CI , 2.58 % -3.40 % ] for no aspirin ; hazard ratio [ HR ] , 0.94 [ 95 % CI , 0.77-1 .15 ] ; P = .54 ) .
RESULTS	Aspirin significantly reduced incidence of nonfatal myocardial infarction ( 0.30 [ 95 % CI , 0.19-0 .47 ] for aspirin vs 0.58 [ 95 % CI , 0.42-0 .81 ] for no aspirin ; HR , 0.53 [ 95 % CI , 0.31-0 .91 ] ; P = .02 ) and transient ischemic attack ( 0.26 [ 95 % CI , 0.16-0 .42 ] for aspirin vs 0.49 [ 95 % CI , 0.35-0 .69 ] for no aspirin ; HR , 0.57 [ 95 % CI , 0.32-0 .99 ] ; P = .04 ) , and significantly increased the risk of extracranial hemorrhage requiring transfusion or hospitalization ( 0.86 [ 95 % CI , 0.67-1 .11 ] for aspirin vs 0.51 [ 95 % CI , 0.37-0 .72 ] for no aspirin ; HR , 1.85 [ 95 % CI , 1.22-2 .81 ] ; P = .004 ) .
CONCLUSIONS	Once-daily , low-dose aspirin did not significantly reduce the risk of the composite outcome of cardiovascular death , nonfatal stroke , and nonfatal myocardial infarction among Japanese patients 60 years or older with atherosclerotic risk factors .
BACKGROUND	clinicaltrials.gov Identifier : NCT00225849 .

###25431086
BACKGROUND	Insecticide-treated nets ( ITNs ) have proven instrumental in the successful reduction of malaria incidence in holoendemic regions during the past decade .
BACKGROUND	As distribution of ITNs throughout sub-Saharan Africa ( SSA ) is being scaled up , maintaining maximal levels of coverage will be necessary to sustain current gains .
BACKGROUND	The effectiveness of mass distribution of ITNs , requires careful analysis of successes and failures if impacts are to be sustained over the long term .
METHODS	Mass distribution of ITNs to a rural Kenyan community along Lake Victoria was performed in early 2011 .
METHODS	Surveyors collected data on ITN use both before and one year following this distribution .
METHODS	At both times , household representatives were asked to provide a complete accounting of ITNs within the dwelling , the location of each net , and the ages and genders of each person who slept under that net the previous night .
METHODS	Other data on household material possessions , education levels and occupations were recorded .
METHODS	Information on malaria preventative factors such as ceiling nets and indoor residual spraying was noted .
METHODS	Basic information on malaria knowledge and health-seeking behaviours was also collected .
METHODS	Patterns of ITN use before and one year following net distribution were compared using spatial and multi-variable statistical methods .
METHODS	Associations of ITN use with various individual , household , demographic and malaria related factors were tested using logistic regression .
RESULTS	After infancy ( < 1 year ) , ITN use sharply declined until the late teenage years then began to rise again , plateauing at 30 years of age .
RESULTS	Males were less likely to use ITNs than females .
RESULTS	Prior to distribution , socio-economic factors such as parental education and occupation were associated with ITN use .
RESULTS	Following distribution , ITN use was similar across social groups .
RESULTS	Household factors such as availability of nets and sleeping arrangements still reduced consistent net use , however .
CONCLUSIONS	Comprehensive , direct-to-household , mass distribution of ITNs was effective in rapidly scaling up coverage , with use being maintained at a high level at least one year following the intervention .
CONCLUSIONS	Free distribution of ITNs through direct-to-household distribution method can eliminate important constraints in determining consistent ITN use , thus enhancing the sustainability of effective intervention campaigns .

###24682379
OBJECTIVE	Randomised control trials ( RCTs ) do not always reflect real-life outcomes for glucose-lowering drugs .
OBJECTIVE	In this work we compared RCT and real-life data on the efficacy of the dipeptidyl peptidase-IV ( DPP-4 ) inhibitor vildagliptin or sulfonylureas when added to metformin .
METHODS	Data were pooled from five RCTs examining vildagliptin ( n = 2,788 ) and sulfonylureas ( glimepiride [ n = 1,259 ] or gliclazide [ n = 433 ] ) , added to metformin .
METHODS	For real-life conditions , data were extracted from an observational study examining vildagliptin ( n = 7,002 ) or sulfonylureas ( n = 3,702 ) , added to metformin monotherapy .
METHODS	Linear regression analyses were performed between the baseline HbA1c and the change in HbA1c ( HbA1c ) after 24 weeks .
RESULTS	Baseline HbA1c correlated to HbA1c ( r ( 2 ) = 0.36 , slope = -0.54 [ 95 % CI -0.55 , -0.53 ; p < 0.0001 ] ) for both treatments .
RESULTS	With sulfonylureas , the slope of the correlation was steeper in the observational study than in RCTs ( interaction coefficient = -0.327 , p < 0.001 ) , whereas for vildagliptin , the slope was virtually identical in the observational study and the RCTs ( interaction coefficient = 0.024 , p = 0.175 ) .
RESULTS	For any given baseline HbA1c , HbA1c with sulfonylureas was smaller in real life than in RCTs , whereas HbA1c with vildagliptin was the same .
CONCLUSIONS	When comparing RCT to real-life data , the decrease in HbA1c from baseline with sulfonylurea treatment is smaller in real life than in RCTs , whereas the reduction with vildagliptin is essentially the same , suggesting that the full power of treatment is retained in real life for vildagliptin but not for sulfonylureas , possibly due to fear of hypoglycaemia .

###24321183
BACKGROUND	Chronic kidney disease ( CKD ) is associated with inflammation .
BACKGROUND	The effects of atorvastatin on biomarkers of inflammation were assessed in CKD patients in the LORD trial .
METHODS	117 patients with serum creatinine > 120 mol/L were randomized to receive atorvastatin 10 mg/day ( 56 ) or placebo ( 61 ) and followed for a mean of 2.5 years .
METHODS	33 individuals with normal kidney function were controls .
METHODS	Outcomes included comparison of changes in pentraxin-3 ( PTX3 ) , TNF - , CRP , IL-6 , IL-8 , and IL-10 between atorvastatin and placebo-treated patients .
RESULTS	At baseline , compared with controls , CKD patients had increased PTX3 ( mean , 1.08 vs. 0.58 ng/mL ; p < 0.001 ) , CRP ( 4.9 vs. 1.5 mg/L ; p < 0.001 ) , IL-8 ( 6.00 vs. 4.58 pg/mL ; p = 0.001 ) , IL-10 ( 59.0 vs. 17.6 pg/mL ; p = 0.007 ) , and TNF - ( 18.0 vs. 5.6 ng/mL ; p < 0.001 ) .
RESULTS	In patients with raised baseline plasma IL-6 / 8/10 and/or PTX3 the eGFR decline during the trial was significantly less in those treated with atorvastatin compared to placebo ( mean change , -3.36 ; vs. + 1.25 mL/min/1 .73 m2/year ; difference , 4.61 95 % CI 0.98 - 8.25 ; p = 0.002 ) , whilst those without raised inflammatory biomarkers showed no difference .
RESULTS	Placebo treated patients with raised TNF - levels had no eGFR decline ( p > 0.90 ) , whereas in atorvastatin-treated patients eGFR declined ( p = 0.05 ) .
CONCLUSIONS	CKD patients with inflammation treated with atorvastatin had significantly less eGFR decline .
CONCLUSIONS	Larger studies using statin therapy , specifically enrolling CKD patients with inflammation , may be worthwhile exploring .

###25306749
OBJECTIVE	To study the effect of metformin on metabolic parameters , body weight ( BW ) , and waist circumference ( WC ) in patients with abdominal obesity ( AO ) .
METHODS	The results of using metformin 2000 mg daily for 3 months in 46 patients with AO .
METHODS	The comparison group consisted of 50 people .
METHODS	BW , WC , and blood pressure ( BP ) were measured ; lipid profile parameters and blood insulin concentrations were determined ; and Homeostasis Model Assessment ( HOMA ) estimates were calculated .
METHODS	Metabolic syndrome ( MS ) and AO were judged by the 2005 International Diabetes Federation ( IDF ) criteria .
RESULTS	The study and comparison groups showed were reductions in BW by 4.2 and 1.7 kg and in WC by 4.2 and 1.1 cm , respectively .
RESULTS	Metformin used in the patients with AO contributed to a more significant improvement in the lipid profile than in those who received no medication .
RESULTS	A decrease in the HOMA index was observed only in the metformin group .
RESULTS	The effects of the drug were more pronounced in MS and insulin resistance .
RESULTS	The use of metformin in the patients with AO decreased lower BW and HOMA index and improved lipid metabolism even in the absence of MS.
CONCLUSIONS	The trial has demonstrated that the people with AO may take metformin could be used in to reduce BW and WC and to treat and prevent MS.

###25895447
OBJECTIVE	Neoadjuvant chemotherapy with 5-fluorouracil plus cisplatin and subsequent esophagectomy with two - to three-field lymphadenectomy is a standard treatment for patients with clinical stage II/III squamous cell carcinoma ( SCC ) of the esophagus .
OBJECTIVE	This study investigates the prognostic factors for patients who received neoadjuvant chemotherapy .
METHODS	Of 164 patients assigned to receive neoadjuvant chemotherapy in the JCOG9907 trial , multivariate analyses were performed for 159 and 149 patients to evaluate the preoperative and the combined preoperative and postoperative prognostic factors , respectively .
RESULTS	The multivariate analyses using preoperative factors showed that clinical stage T3 [ vs. cT1-2 ; hazard ratio ( HR ) 3.60 , p = 0.0007 ] and serum albumin ( Alb ) < 4.0 g/dl ( vs. 4.0 g/dl ; HR 2.29 , p = 0.0005 ) were associated with a poor prognosis .
RESULTS	Four independent prognostic factors were identified by multivariate analysis of both preoperative and postoperative factors : pathological curability B ( pB ; R0 with stage IV or pD < pN ) or pC [ microscopic or macroscopic residual tumor ( R1/R2 ) ] [ vs. pA ( R0 ) ; HR 1.93 , p = 0.015 ] , pathological stage N1 ( vs. pN0 ; HR 3.86 , p = 0.0012 ) , cT3 ( vs. cT1-2 ; HR 2.80 , p = 0.0073 ) , and serum Alb < 4.0 g/dl ( vs. 4.0 g/dl ; HR 2.03 , p = 0.0069 ) .
CONCLUSIONS	Preoperative cT stage , Alb , and postoperative pathological findings are independent prognostic factors for patients undergoing neoadjuvant chemotherapy for advanced thoracic esophageal SCC .
CONCLUSIONS	This analysis may aid in stratification according to individual patient risk .

###25454802
BACKGROUND	Insomnia is frequent in schizophrenia and may contribute to cognitive impairment as well as overuse of weight inducing sedative antipsychotics .
BACKGROUND	We investigated the effects of eszopiclone on sleep and cognition for patients with schizophrenia-related insomnia in a double-blind placebo controlled study , followed by a two-week , single-blind placebo phase .
METHODS	Thirty-nine clinically stable outpatients with schizophrenia or schizoaffective disorder and insomnia were randomized to either 3mg eszopiclone ( n = 20 ) or placebo ( n = 19 ) .
METHODS	Primary outcome measure was change in Insomnia Severity Index ( ISI ) over 8 weeks .
METHODS	Secondary outcome measure was change in MATRICS Consensus Cognitive Battery ( MATRICS ) .
METHODS	Sleep diaries , psychiatric symptoms , and quality of life were also monitored .
RESULTS	ISI significantly improved more in eszopiclone ( mean = -10.7 , 95 % CI = -13.2 ; -8.2 ) than in placebo ( mean = -6.9 , 95 % CI = -9.5 ; -4.3 ) with a between-group difference of -3.8 ( 95 % CI = -7.5 ; -0.2 ) .
RESULTS	MATRICS score change did not differ between groups .
RESULTS	On further analysis there was a significant improvement in the working memory test , letter-number span component of MATRICS ( mean = 9.89.2 , z = -2.00 , p = 0.045 ) only for subjects with schizophrenia on eszopiclone .
RESULTS	There were improvements in sleep diary items in both groups with no between-group differences .
RESULTS	Psychiatric symptoms remained stable .
RESULTS	Discontinuation rates were similar .
RESULTS	Sleep remained improved during single-blind placebo phase after eszopiclone was stopped , but the working memory improvement in patients with schizophrenia was not durable .
CONCLUSIONS	Eszopiclone stands as a safe and effective alternative for the treatment of insomnia in patients with schizophrenia .
CONCLUSIONS	Its effects on cognition require further study .

###24534638
OBJECTIVE	The first large-scale randomised trial ( Immediate Management of the Patient with Rupture : Open Versus Endovascular repair [ IMPROVE ] ) for endovascular repair of ruptured abdominal aortic aneurysm ( rEVAR ) has recently finished recruiting patients .
OBJECTIVE	The aim of this study was to examine the impact on survival after rEVAR when the IMPROVE protocol was initiated in a high volume abdominal aortic aneurysm ( AAA ) centre previously performing rEVAR .
METHODS	One hundred and sixty-nine patients requiring emergency infrarenal AAA repair from January 2006 to April 2013 were included .
METHODS	Eighty-four patients were treated before ( 38 rEVAR , 46 open ) and 85 ( 31 rEVAR , 54 open ) were treated during the trial period .
METHODS	A retrospective analysis was performed .
RESULTS	Before the trial , there was a significant survival benefit for rEVAR over open repair ( 90-day mortality 13 % vs. 30 % , p = .04 , difference remained significant up to 2 years postoperatively ) .
RESULTS	This survival benefit was lost after starting randomisation ( 90-day mortality 35 % vs. 33 % , p = .93 ) .
RESULTS	There was an increase in overall 30-day mortality from 15 % to 31 % ( p = .02 ) , while there was no change for open repair ( p = .438 ) .
RESULTS	There was a significant decrease in general anaesthetic use ( p = .002 ) for patients treated during the trial .
RESULTS	Randomised patients had shorter hospital and intensive treatment unit stays ( p = .006 and p = .03 respectively ) .
CONCLUSIONS	The change in survival seen during the IMROVE trial highlights the need for randomised rather than cohort data to eliminate selection bias .
CONCLUSIONS	These results from a single centre reinforce those recently reported in IMPROVE .

###24768981
OBJECTIVE	To assess the efficacy of ketoprofen vs intravaginal misoprostol for pain relief during outpatient hysteroscopy .
METHODS	Prospective , randomized , single-blind , placebo-controlled clinical trial ( Canadian Task Force classification I ) .
METHODS	Tertiary medical center .
METHODS	One hundred fifty women referred for hysteroscopy between January and October 2013 .
METHODS	Women were randomized to receive vaginal misoprostol , 400 g , with 100 mL of 5 % intravenous glucose ( misoprostol arm ) ; intravenous ketoprofen , 50 mg/mL , in 100 mL 5 % glucose with intravaginal placebo ( ketoprofen arm ) ; or vaginal placebo tablets , 100 mL 5 % intravenous glucose ( placebo arm ) before outpatient hysteroscopy .
RESULTS	A visual analog scale ( VAS ) was used for 1-dimensional pain assessment .
RESULTS	Patients were asked to mark a VAS score before , during , and at 5 and 15 minutes after the procedure .
RESULTS	Median VAS scores during and directly after the anesthesia-free hysteroscopy were significantly lower in the misoprostol group than in the ketoprofen ( p = .02 ) or placebo ( p = .006 ) groups .
RESULTS	There were no statistical differences between the 3 arms in median VAS score assessed at 15 minutes after the procedure ( p = .16 ) .
RESULTS	There were no differences in procedure time between groups ( p = .16 ) .
CONCLUSIONS	When administrated 4 hours before the procedure , 400 g vaginal misoprostol seems to reduce the pain during and immediately after hysteroscopy .
CONCLUSIONS	The effect does not depend on patient age , hormone status , parity , or type of outpatient hysteroscopy ( operative or diagnostic ) .

###24445685
OBJECTIVE	The aim of this study was to evaluate the effectiveness of oral n-acetyl cysteine , as a potential nephroprotective agent , in preventing and/or attenuating amphotericin B-induced electrolytes imbalances .
METHODS	During a one year period , patients were to receive conventional amphotericin b for any indication for at least one week and were randomly allocated to receive either placebo or 600 mg oral n-acetyl cysteine twice daily during the treatment course of amphotericin b. Demographic and clinical data of the study population were gathered .
METHODS	Different aspects of amphotericin b nephrotoxicity including decrease of glomerular filtration rate , hypokalemia , hypomagnesemia , renal magnesium and potassium wasting were assessed .
METHODS	Each patient was monitored for any adverse reaction to n-acetyl cysteine .
METHODS	Sixteen and 14 patients in the n-acetyl cysteine and placebo groups completed the study , 3incidences of hypokalemia ( 75 % versus 70 % ; P = 0.724 ) and hypomagnesemia ( 30 % versus 20 % ; P = 0.468 ) did not differ significantly between placebo and NAC groups , respectively .
METHODS	Although the rate of AmB nephrotoxicity was higher in the placebo than in the NAC group ( 60 % versus 40 % ) , this difference was not statistically significant ( P = 0.209 ) even after adjusting for probable associated factors of amphotericin b nephrotoxicity ( P = 0.206 ) .
METHODS	The incidence as well as time of onset of electrolyte abnormalities also did not differ significantly between placebo and n-acetyl cysteine groups .
METHODS	About 44 % of n-acetyl cysteine recipients experienced new onset nausea and a mild unpleasant taste during the study .
CONCLUSIONS	Oral n-acetyl cysteine during the amphotericin B treatment course was not significantly effective in preventing or mitigating different features of its nephrotoxicity including decrease of glomerular filtration rate , hypokalemia , hypomagnesemia , and renal potassium as well as magnesium wasting .

###25853591
OBJECTIVE	To determine whether regional anticoagulation of continuous renal replacement therapy circuits using citrate and calcium prolongs circuit life and/or affects circulating cytokine levels compared with regional anticoagulation using heparin and protamine .
METHODS	Multicenter , parallel group randomized controlled trial .
METHODS	Seven ICUs in Australia and New Zealand .
METHODS	Critically ill adults requiring continuous renal replacement therapy .
METHODS	Patients were randomized to receive one of two methods of regional circuit anticoagulation : citrate and calcium or heparin and protamine .
RESULTS	The primary outcome was functional circuit life measured in hours , assessed using repeated events survival analysis .
RESULTS	In addition , we measured changes in interleukin-6 , interleukin-8 , and interleukin-10 blood levels .
RESULTS	We randomized 212 subjects who were treated with 857 continuous renal replacement therapy circuits ( median 2 circuits per patient [ interquartile range , 1-6 ] , 390 in citrate group vs 467 in heparin group ) .
RESULTS	The groups were well matched for baseline characteristics .
RESULTS	Patients receiving regional continuous renal replacement therapy anticoagulation with heparin and protamine were more likely to experience circuit clotting than those receiving citrate and calcium ( hazard ratio , 2.03 [ 1.36-3 .03 ] ; p < 0.0005 ; 857 circuits ) .
RESULTS	The median lifespan of the first study circuit in each patient was 39.2 hours ( 95 % CI , 32.1-48 .0 hr ) in the citrate and calcium group versus 22.8 hours ( 95 % CI , 13.3-34 .0 hr ) in the heparin and protamine group ( log rank p = 0.0037 , 204 circuits ) .
RESULTS	Circuit anticoagulation with citrate and calcium had similar effects on cytokine levels compared with heparin and protamine anticoagulation .
RESULTS	There were more adverse events in the group assigned to heparin and protamine anticoagulation ( 11 vs 2 ; p = 0.011 ) .
CONCLUSIONS	Regional citrate and calcium anticoagulation prolongs continuous renal replacement therapy circuit life compared with regional heparin and protamine anticoagulation , does not affect cytokine levels , and is associated with fewer adverse events .

###24322628
BACKGROUND	The objective of our study is to determine the relative efficacy of the 2 reduction maneuvers , hyperpronation ( HP ) and supination-flexion ( SF ) , in pulled elbow ( PE ) .
METHODS	We conducted a randomized , prospective study of 2 reduction maneuvers in 115 patients with PE and a mean age of 2 years and 3 months .
METHODS	Patients were randomly divided into 2 groups : group A , with 65 children ( 56.52 % ) who underwent HP ; and group B , with 50 children ( 43.47 % ) who underwent SF .
RESULTS	In 97.39 % of the children , reduction was achieved by manipulation .
RESULTS	Reduction was achieved at first attempt ( using either maneuver ) in 101 of 115 patients ( 87.82 % ) , with 93.84 % success for HP and 80 % for SF ( P = 0.0243 ) .
RESULTS	Most patients in whom our first attempts failed ( 85.71 % ) had undergone prior manipulation : 100 % of treatment failures from group A ; and 80 % of failures from group B. Most ( 95.04 % ) patients in whom our first attempts succeeded had not undergone prior manipulation : 93.44 % from group A ; and 97.5 % from group B.
RESULTS	A significant relationship was found when comparing those who had undergone prior manipulation from group A ( P = 0.0001 ) and group B ( P = 0.000000072 ) .
CONCLUSIONS	Although both SF and HP are effective for reduction of PE , a higher first-attempt success rate was achieved by HP , and this should therefore be the first maneuver used .
CONCLUSIONS	In recurring cases , it would seem appropriate to teach the child 's parents the HP maneuver as the most effective and easiest to do .

###24335227
OBJECTIVE	The Interventional Management of Stroke ( IMS ) - III trial randomized patients with acute ischemic stroke to intravenous tissue-type plasminogen activator ( tPA ) plus endovascular therapy versus intravenous tPA therapy alone within 3 hours from symptom onset .
OBJECTIVE	A predefined secondary hypothesis was that subjects with significant early ischemic change on the baseline scan would not respond to endovascular therapy .
METHODS	The primary outcome was 90-day modified Rankin Scale score 0 to 2 .
METHODS	The baseline and follow-up computed tomographic ( CT ) scan images were reviewed centrally and blinded to any clinical information .
METHODS	We assessed whether the baseline Alberta Stroke Program Early CT Score ( ASPECTS ) predicted outcome and interacted with study treatment .
METHODS	We analyzed subgroups defined by time from onset to intravenous tPA initiation and baseline occlusion status at a prespecified = 0.01 .
RESULTS	Baseline demographic and clinical characteristics of 656 randomized patients were similar between subjects with a baseline ASPECTS 8 to 10 ( 58 % of the study sample ) versus 0 to 7 .
RESULTS	Subjects with ASPECTS 8 to 10 were almost twice as likely ( relative risk , 1.8 ; 99 % confidence interval , 1.4-2 .4 ) to achieve a favorable outcome .
RESULTS	There was insufficient evidence of a treatment-by-ASPECTS interaction .
RESULTS	In those treated with onset to intravenous tPA < 120 minutes , in CT angiography-proven internal carotid artery or middle cerebral artery occlusion , and in both , results were similar .
RESULTS	The probability of achieving recanalization ( arterial occlusion lesion , 2-3 ) of the primary arterial occlusive lesion ( relative risk , 1.3 ; 99 % confidence interval , 1.0-1 .8 ) or achieving thrombolysis in cerebral ischemia score 2b/3 reperfusion ( relative risk 2.0 ; 99 % confidence interval , 1.2-3 .2 ) was higher among subjects with higher ASPECTS .
CONCLUSIONS	ASPECTS is a strong predictor of outcome and a predictor of reperfusion .
CONCLUSIONS	ASPECTS did not identify a subpopulation of subjects that particularly benefitted from endovascular therapy immediately after routine intravenous tPA .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00359424 .

###24379055
BACKGROUND	Proton pump inhibitors ( PPIs ) are a major breakthrough in the medical management of gastroesophageal reflux disease ( GERD ) .
BACKGROUND	In several patients with non erosive reflux disease symptoms ( NERD ) the response to PPIs is partial or limited and symptoms relief needs the administration of additional medications .
OBJECTIVE	The aim of this study was to evaluate the effect of a new medical device , based on an oral fixed combination of hyaluronic acid and chondroitin-sulphate ( HA+CS ) , in a bioadhesive carrier , in adults with symptoms of non erosive gastroesophageal reflux and with a low response to PPIs .
METHODS	Twenty patients who had experienced heartburn and/or acid regurgitation for at least 3 days during a 7 day run-in period , without endoscopic mucosal breaks , were randomized in a double blind crossover study to receive four daily doses of a fixed oral combination of HA+CS and placebo for 14 days .
METHODS	Relief of cardinal symptoms of GERD was evaluated at the end of each period .
RESULTS	A significant greater Sum of Symptoms Intensity Difference , compared to placebo , was observed after HA+CS treatment ( -2.7 vs 0.5 - p < 0.01 ) , being both heartburn ( -1.6 vs 0.5 - p < 0.03 ) and acid regurgitation ( -1.1 vs 0.1 - p < 0.03 ) significantly improved by the medical device .
RESULTS	A speed of action 30 min was significantly more frequently reported by patients during HA+CS administration than with placebo ( 60 % vs 30 % - p = 0.05 ) .
RESULTS	Total disappearance of symptoms was observed in 50 % of the patients compared to 10 % during placebo administration ( p = 0.01 between group comparison ) .
CONCLUSIONS	A fixed combination of HA+CS has demonstrated to be effective in gastroesophageal reflux control , with a rapid onset of action .

###25452447
OBJECTIVE	Insomnia is a distressing and often persisting consequence of cancer .
OBJECTIVE	Although cognitive behavioral therapy for insomnia ( CBT-I ) is the treatment of choice in the general population , the use of CBT-I in patients with cancer is complicated , because it can result in transient but substantial increases in daytime sleepiness .
OBJECTIVE	In this study , we evaluated whether CBT-I , in combination with the wakefulness-promoting agent armodafinil ( A ) , results in better insomnia treatment outcomes in cancer survivors than CBT-I alone .
METHODS	We report on a randomized trial of 96 cancer survivors ( mean age , 56 years ; female , 87.5 % ; breast cancer , 68 % ) .
METHODS	The primary analyses examined whether one of the 7-week intervention conditions ( ie , CBT-I , A , or both ) , when compared with a placebo capsule ( P ) group , produced significantly greater clinical gains .
METHODS	Insomnia was assessed by the Insomnia Severity Index and sleep quality by the Pittsburgh Sleep Quality Inventory .
METHODS	All patients received sleep hygiene instructions .
RESULTS	Analyses controlling for baseline differences showed that both the CBT-I plus A ( P = .001 ) and CBT-I plus P ( P = .010 ) groups had significantly greater reductions in insomnia severity postintervention than the P group , with effect sizes of 1.31 and 1.02 , respectively .
RESULTS	Similar improvements were seen for sleep quality .
RESULTS	Gains on both measures persisted 3 months later .
RESULTS	CBT-I plus A was not significantly different from CBT-I plus P ( P = .421 ) , and A alone was not significantly different from P alone ( P = .584 ) .
CONCLUSIONS	CBT-I results in significant and durable improvements in insomnia and sleep quality .
CONCLUSIONS	A did not significantly improve the efficacy of CBT-I or independently affect insomnia or sleep quality .

###25415314
OBJECTIVE	As airway management specialists , thoracic surgeons should be familiar with percutaneous dilatational tracheostomy .
OBJECTIVE	To optimize the learning curve , we propose a home-made pig model obtained from a slaughterhouse for training residents in the technical aspects of performing percutaneous dilatational tracheostomy .
OBJECTIVE	The satisfaction of the residents ' training experience using this model was compared with that using a standard manikin model .
METHODS	Fifty residents participated in the present study .
METHODS	At the end of the session , each participant completed a questionnaire assessing the pig model and the manikin by assigning a score ( ranging from 1 to 4 ) to five specific characteristics including ( i ) reality of skin turgor ; ( ii ) landmark recognition ; ( iii ) feasibility of the procedure ; ( iv ) reality of the model and ( v ) preference of each model .
METHODS	The differences between models were statistically analysed .
RESULTS	Forty-five participants completed the study .
RESULTS	The pig model , compared with the manikin model , presented a higher value regarding the reality of skin turgor ( 1.7 0.5 vs 0.4 0.8 ; respectively , P < 0.0001 ) ; landmark recognition ( 3.8 0.5 vs 2.0 0.5 ; respectively ; P < 0.0001 ) and reality of the model ( 3.0 0.8 vs 1.3 1.0 ; respectively ; P < 0.0001 ) .
RESULTS	No difference was found regarding the feasibility of the procedure ( 3.7 0.6 vs 3.5 0.5 ; respectively , P = 0.1 ) .
RESULTS	The pig model was preferred to the manikin ( 3.2 0.7 vs 1.6 1.0 ; respectively , P < 0.0001 ) .
CONCLUSIONS	Our pig model allowed residents to develop the skills required for successful percutaneous dilatational tracheostomy .
CONCLUSIONS	In particular , they developed confidence with certain manoeuvres such as needle and guide-wire placement , dilatation of the trachea and insertion of a cannula , before attempting the procedure on a live patient .

###26004248
OBJECTIVE	Stress has been associated with high-calorie , low-nutrient food intake ( HCLN ) and emotion-driven eating ( EDE ) .
OBJECTIVE	However , effects on healthy food intake remain unknown .
OBJECTIVE	This study examined two facets of stress ( self-efficacy , perceived helplessness ) and food consumption , mediated by EDE .
METHODS	Cross-sectional data from fourth-graders ( n = 978 ; 52 % female , 28 % Hispanic ) in an obesity intervention used self-report to assess self-efficacy , helplessness , EDE , fruit/vegetable ( FV ) intake , and high-calorie/low-nutrient ( HCLN ) food .
RESULTS	Higher stress self-efficacy was associated with higher FV intake , = .354 , p < 0.001 , and stress perceived helplessness had an indirect effect on HCLN intake through emotion-driven eating , indirect effect = .094 , p < 0.001 ; ( 2 ) ( 347 ) = 659.930 , p < 0.001 , CFI = 0.940 , TLI = 0.930 , RMSEA = 0.030 , p = 1.00 , adjusting for gender , ethnicity , BMI z-score , and program group .
CONCLUSIONS	Stress self-efficacy may be more important for healthy food intake and perceived helplessness may indicate emotion-driven eating and unhealthy snack food intake .
CONCLUSIONS	Obesity prevention programs may consider teaching stress management techniques to avoid emotion-driven eating .

###24839884
OBJECTIVE	Preliminary evidence suggests that omega-3 fatty acids may reduce hyperactivity in children with autism spectrum disorder ( ASD ) .
OBJECTIVE	We sought to examine the feasibility of a novel , Internet-based clinical trial design to evaluate the efficacy of this supplement .
METHODS	E-mail invitations were sent to parents of children aged 5 to 8 years enrolled in the Interactive Autism Network .
METHODS	All study procedures , including screening , informed consent , and collection of outcome measures took place over the Internet .
METHODS	The primary outcome measures were parent - and teacher-rated changes in hyperactivity on the Aberrant Behavior Checklist ( ABC-H ) .
RESULTS	During the 6-week recruitment period , 57 children from 28 states satisfied all eligibility criteria and were randomly assigned to 1.3 grams of omega-3 fatty acids or an identical placebo daily for 6 weeks .
RESULTS	Outcome assessments were obtained from all 57 participants and 57 teachers , and the study was completed in 3 months .
RESULTS	Children in the omega-3 fatty acid group had a greater reduction in hyperactivity ( -5.3 points ) compared to the placebo group ( -2.6 points ) , but the difference was not statistically significant ( 1.9-point greater improvement in the omega-3 group , 95 % CI = -2.2 to 5.2 ) .
RESULTS	Adverse events were rare and not associated with omega-3 fatty acids .
RESULTS	Participant feedback was positive .
CONCLUSIONS	Internet-based , randomized controlled trials of therapies in children with ASD are feasible and may lead to marked reductions in the time and cost of completing trials .
CONCLUSIONS	A larger sample size is required to definitively determine the efficacy of omega-3 fatty acids .
CONCLUSIONS	Clinical trial registration information-Omega-3 Fatty Acids for Hyperactivity Treatment in Autism Spectrum Disorder ; http://clinicaltrials.gov; NCT01694667 .

###24552317
BACKGROUND	Concurrent treatment with temozolomide and radiotherapy followed by maintenance temozolomide is the standard of care for patients with newly diagnosed glioblastoma .
BACKGROUND	Bevacizumab , a humanized monoclonal antibody against vascular endothelial growth factor A , is currently approved for recurrent glioblastoma .
BACKGROUND	Whether the addition of bevacizumab would improve survival among patients with newly diagnosed glioblastoma is not known .
METHODS	In this randomized , double-blind , placebo-controlled trial , we treated adults who had centrally confirmed glioblastoma with radiotherapy ( 60 Gy ) and daily temozolomide .
METHODS	Treatment with bevacizumab or placebo began during week 4 of radiotherapy and was continued for up to 12 cycles of maintenance chemotherapy .
METHODS	At disease progression , the assigned treatment was revealed , and bevacizumab therapy could be initiated or continued .
METHODS	The trial was designed to detect a 25 % reduction in the risk of death and a 30 % reduction in the risk of progression or death , the two coprimary end points , with the addition of bevacizumab .
RESULTS	A total of 978 patients were registered , and 637 underwent randomization .
RESULTS	There was no significant difference in the duration of overall survival between the bevacizumab group and the placebo group ( median , 15.7 and 16.1 months , respectively ; hazard ratio for death in the bevacizumab group , 1.13 ) .
RESULTS	Progression-free survival was longer in the bevacizumab group ( 10.7 months vs. 7.3 months ; hazard ratio for progression or death , 0.79 ) .
RESULTS	There were modest increases in rates of hypertension , thromboembolic events , intestinal perforation , and neutropenia in the bevacizumab group .
RESULTS	Over time , an increased symptom burden , a worse quality of life , and a decline in neurocognitive function were more frequent in the bevacizumab group .
CONCLUSIONS	First-line use of bevacizumab did not improve overall survival in patients with newly diagnosed glioblastoma .
CONCLUSIONS	Progression-free survival was prolonged but did not reach the prespecified improvement target .
CONCLUSIONS	( Funded by the National Cancer Institute ; ClinicalTrials.gov number , NCT00884741 . )

###24393220
BACKGROUND	The most effective and efficient model for providing organized stroke care remains uncertain .
BACKGROUND	This study aimed to compare the effect of two models in a randomized controlled trial .
METHODS	Patients with acute stroke were randomized on day one of admission to combined , co-located acute/rehabilitation stroke care or traditionally separated acute/rehabilitation stroke care .
METHODS	Outcomes measured at baseline and 90 days postdischarge included functional independence measure , length of hospital stay , and functional independence measure efficiency ( change in functional independence measure score total length of hospital stay ) .
RESULTS	Among 41 patients randomized , 20 were allocated co-located acute/rehabilitation stroke care and 21 traditionally separated acute/rehabilitation stroke care .
RESULTS	Baseline measurements showed no significant difference .
RESULTS	There was no significant difference in functional independence measure scores between the two groups at discharge and again at 90 days postdischarge ( co-located acute/rehabilitation stroke care : 103.6 22.2 vs. traditionally separated acute/rehabilitation stroke care : 99.5 27.7 ; P = 0.77 at discharge ; co-located acute/rehabilitation stroke care : 109.5 21.7 vs. traditionally separated acute/rehabilitation stroke care : 104.4 27.9 ; P = 0.8875 at 90 days post-discharge ) .
RESULTS	Total length of hospital stay was 5.28 days less in co-located acute/rehabilitation stroke care compared with traditionally separated acute/rehabilitation stroke care ( 24.15 3.18 vs. 29.42 4.5 , P = 0.35 ) .
RESULTS	There was significant improvement in functional independence measure efficiency score among participants assigned to co-located acute/rehabilitation stroke care compared with traditionally separated acute/rehabilitation stroke care ( co-located acute/rehabilitation stroke care : median 1.60 , interquartile range : 0.87-2 .81 ; traditionally separated acute/rehabilitation stroke care : median 0.82 , interquartile range : 0.27-1 .57 , P = 0.0393 ) .
RESULTS	Linear regression analysis revealed a high inverse correlation ( R ( 2 ) = 0.89 ) between functional independence measure efficiency and time spent in the acute stroke unit .
CONCLUSIONS	This proof-of-concept study has shown that co-located acute/rehabilitation stroke care was just as effective as traditionally separated acute/rehabilitation stroke care as reflected in functional independence measure scores , but significantly more efficient as shown in greater functional independence measure efficiency .
CONCLUSIONS	Co-located acute/rehabilitation stroke care has potential for significantly improved hospital bed utilization with no patient disadvantage .

###24251360
BACKGROUND	Observational evidence suggests that the use of a genotype-guided dosing algorithm may increase the effectiveness and safety of acenocoumarol and phenprocoumon therapy .
METHODS	We conducted two single-blind , randomized trials comparing a genotype-guided dosing algorithm that included clinical variables and genotyping for CYP2C9 and VKORC1 with a dosing algorithm that included only clinical variables , for the initiation of acenocoumarol or phenprocoumon treatment in patients with atrial fibrillation or venous thromboembolism .
METHODS	The primary outcome was the percentage of time in the target range for the international normalized ratio ( INR ; target range , 2.0 to 3.0 ) in the 12-week period after the initiation of therapy .
METHODS	Owing to low enrollment , the two trials were combined for analysis .
METHODS	The primary outcome was assessed in patients who remained in the trial for at least 10 weeks .
RESULTS	A total of 548 patients were enrolled ( 273 patients in the genotype-guided group and 275 in the control group ) .
RESULTS	The follow-up was at least 10 weeks for 239 patients in the genotype-guided group and 245 in the control group .
RESULTS	The percentage of time in the therapeutic INR range was 61.6 % for patients receiving genotype-guided dosing and 60.2 % for those receiving clinically guided dosing ( P = 0.52 ) .
RESULTS	There were no significant differences between the two groups for several secondary outcomes .
RESULTS	The percentage of time in the therapeutic range during the first 4 weeks after the initiation of treatment in the two groups was 52.8 % and 47.5 % ( P = 0.02 ) , respectively .
RESULTS	There were no significant differences with respect to the incidence of bleeding or thromboembolic events .
CONCLUSIONS	Genotype-guided dosing of acenocoumarol or phenprocoumon did not improve the percentage of time in the therapeutic INR range during the 12 weeks after the initiation of therapy .
CONCLUSIONS	( Funded by the European Commission Seventh Framework Programme and others ; EU-PACT ClinicalTrials.gov numbers , NCT01119261 and NCT01119274 . )

###24462856
OBJECTIVE	To determine whether providing additional information to the standard consent process , in the form of a multimedia module ( MM ) , improves patient knowledge about operative laparoscopy without increasing anxiety .
METHODS	Randomized controlled trial ( Canadian Task Force classification I ) .
METHODS	Two outpatient gynecologic clinics , one in a private hospital and the other in a public teaching hospital .
METHODS	Forty-one women aged 19 to 51 years ( median , 35.6 years ) requiring operative laparoscopy for investigation and treatment of pelvic pain .
METHODS	Following the standard informed consent process , patients were randomized to watch the MM ( intervention group , n = 21 ) or not ( control group , n = 20 ) .
METHODS	The surgeon was blinded to the group assignments .
METHODS	All patients completed a knowledge questionnaire and the Spielberger short-form State-Trait Anxiety Inventory .
METHODS	Six weeks after recruitment , patients completed the knowledge questionnaire and the State-Trait Anxiety Inventory a second time to assess knowledge retention and anxiety scores .
RESULTS	Patient knowledge of operative laparoscopy , anxiety level , and acceptance of the MM were recorded .
RESULTS	The MM intervention group demonstrated superior knowledge scores .
RESULTS	Mean ( SE ) score in the MM group was 11.3 ( 0.49 ) , and in the control group was 7.9 ( 0.50 ) ( p < .001 ) ( maximum score , 14 ) .
RESULTS	This did not translate into improved knowledge scores 6 weeks later ; the score in the MM group was 8.4 ( 0.53 ) vs. 7.8 ( 0.50 ) in the control group ( p = .44 ) .
RESULTS	There was no difference in anxiety levels between the groups at intervention or after 6 weeks .
RESULTS	Overall , patients found the MM acceptable , and 18 women ( 86 % ) in the intervention group and 12 ( 60 % ) in the control group stated they would prefer this style of informed consent in the future .
CONCLUSIONS	Use of an MM enhances the informed consent process by improving patient knowledge , in the short term , without increasing anxiety .

###24464452
BACKGROUND	Recently , an increased scientific interest was focused on mild approaches for ovarian stimulation in clinical practice .
BACKGROUND	Milder stimulation aims to develop safer and more patient-friendly protocols which are more physiological , less drug use , less expensive and the risks of treatment are highly minimized .
OBJECTIVE	To investigate the efficacy and safety of a mild ovarian stimulation protocol in patients at high risk of developing ovarian hyperstimulation syndrome ( OHSS ) , compared to conventional long down-regulation protocol .
METHODS	This a prospective , open , randomized study , included 349 infertile patients considered at high risk of developing OHSS , undergoing in vitro fertilization treatment in two private assisted reproduction centers .
METHODS	The patients were randomized into two groups : group A ( n = 148 ) had a mild/minimal stimulation protocol of recombinant FSH ( rFSH ) combined with GnRH antagonist .
METHODS	Group B ( n = 201 ) ( control group ) had a standard long protocol of rFSH combined with GnRH agonist .
RESULTS	There was no significant difference observed between the two groups regarding the mean number of oocytes retrieved per patient , mature metaphase II oocytes , fertilization rate , and embryo cleavage rate .
RESULTS	Significantly higher implantation rate ( 21.5 vs 14.5 % ) ( p < 0.05 ) , pregnancy rate ( 37.7 vs 23.4 % ) ( p < 0.05 ) , and delivery rate ( 32.8 vs 20.1 % ) ( p < 0.05 ) were observed in favor of groups A compared to group B. Lower proportion of patients ( 4.7 % ) , though not statistically significant , has developed OHSS in group A compared to group B ( 8.4 % ) .
CONCLUSIONS	Our study shows that mild stimulation regimen is highly effective for ovarian stimulation of patients who have experienced OHSS complication without increasing the risk of OHSS .

###24893872
OBJECTIVE	Vessel-sealing devices ( VSDs ) are widely used for various surgical procedures , including thoracoscopic surgery , but very few reports have compared their safety and usefulness with human thoracoscopic lobectomy procedures not employing VSDs .
METHODS	Primary lung cancer patients for whom a thoracoscopic lobectomy involving mediastinal lymph node dissection was planned in our department from April 2011 to March 2013 were recruited for the study .
METHODS	Patients were randomly allocated to a control group ( n = 14 ) or a VSD group ( n = 44 ) , which comprised three sub-groups , namely EnSeal ( n = 17 ) , LigaSure ( n = 15 ) and Harmonic ( n = 12 ) .
METHODS	The control group comprised patients undergoing surgery solely with ligation and conventional electrocautery .
METHODS	EnSeal , LigaSure and Harmonic were chosen because they are the three most popular disposable VSDs used in Japan .
METHODS	In the VSD groups , the proximal side of pulmonary artery stumps ( 7 mm diameter ) were ligated and then treated with respective devices .
METHODS	Primary end-points were burst pressure of the pulmonary artery stump ( measured using resected specimens ) , operative time , intraoperative blood loss , instances of endostapler use , intraoperative surgeon stress ( assessed by visual analogue scale ) and postoperative drainage volume and duration .
METHODS	As a secondary objective , the individual VSD groups were also compared with each other .
RESULTS	The burst pressure of ligation-treated pulmonary artery stumps was higher than that of VSD-treated stumps ( P < 0.0001 ) .
RESULTS	The burst pressure of < 5-mm-wide VSD-treated stumps was higher than that of 5-mm-wide stumps ( P = 0.0421 ) .
RESULTS	However , the burst pressure for all groups and all vessel diameters was sufficient to withstand the physiological pulmonary artery pressure .
RESULTS	The VSD group demonstrated reduced intraoperative blood loss ( P = 0.0241 ) , surgeon stress ( P = 0.0002 ) , postoperative drainage volume ( P = 0.0358 ) and shortened postoperative drainage duration ( P = 0.0449 ) .
RESULTS	Operative time and the instances of endostapler use did not significantly differ .
RESULTS	Comparison between each of the VSD groups revealed no significant differences .
RESULTS	None of the patients experienced serious perioperative complications or died because of surgery .
CONCLUSIONS	VSD is simple and safe to use in thoracoscopic lobectomy involving mediastinal lymph node dissection for primary lung cancer .
CONCLUSIONS	Furthermore , none of the VSDs used in this study presented any observable differences in quality that could lead to clinical problems .

###24956970
OBJECTIVE	Hypertension is associated with dyslipidemia .
OBJECTIVE	Thiazides adversely affect serum lipid levels in hypertensives .
OBJECTIVE	There is currently a dearth of information on benefits of aerobic exercise training on serum lipid levels in individuals on thiazides and this study aimed at bridging this gap in knowledge .
METHODS	This randomized-controlled trial involved 120 newly-diagnosed adults with essential hypertension ( 65 years ) .
METHODS	They were treated with 50 mg of hydrochlorothiazide + 5 mg of hydrochloride amiloride and 5 or 10 mg of amlodipine for 4-6 weeks before they were randomly assigned into exercise group ( EG ) and control croup ( CG ) .
METHODS	Only EG underwent 12-week aerobic dance training at 50-70 % of heart rate reserve three times per week .
METHODS	Low-density lipoprotein cholesterol ( LDL-C ) , high-density lipoprotein cholesterol , triglyceride and total cholesterol were measured and recorded at baseline and post-study .
RESULTS	Eighty-eight ( 45 in EG and 43 in CG ) of 120 participants randomly assigned to groups completed the study .
RESULTS	Systolic ( p = 0.370 ) and diastolic ( p = 0.771 ) blood pressures ( BP ) were similar between the two groups at baseline .
RESULTS	Systolic ( p < 0.001 ) and diastolic ( p < 0.001 ) BPs reduced significantly in exercise and control groups .
RESULTS	LDL-C ( from 120.10 33.41 to 110.50 31.68 mg/dl ; p = 0.037 ) and triglyceride ( from 117.49 45.12 to 100.63 35.42 mg/dl ; p = 0.002 ) decreased in EG post-study but no significant between-group differences were observed .
CONCLUSIONS	Although , LDL-C and triglyceride are reduced after aerobic dance training , they were not any more than without it .
CONCLUSIONS	Aerobic dance training has favorable effects on LDL-C , triglyceride , and systolic and diastolic BP in individuals with hypertension on a thiazide .

###24531244
BACKGROUND	This randomized , double-blind study was designed to assess the effect of perioperative remifentanil with controlled hypotension on intraoperative bleeding , postoperative edema , and ecchymosis .
METHODS	Fifty-two patients undergoing rhinoplasty were divided into 2 groups .
METHODS	The remifentanil group received 1 g kg ( -1 ) intravenously as a bolus before induction of anesthesia , 0.5 to 1 g kg ( -1 ) h ( -1 ) by continuous intravenous infusion during the operation .
METHODS	After anesthesia induction with propofol ( 2-3 mg kg ( -1 ) ) and fentanyl ( 1-15 g kg ( -1 ) ) , muscle relaxation was achieved with rocuronium ( 0.45-0 .90 mg kg ( -1 ) ) .
METHODS	Mean arterial pressure was maintained at 50 to 60 mm Hg in controlled hypotensive anesthesia achieved using remifentanil infusion .
METHODS	Perioperative hemodynamics and bleeding ; early postoperative pain and agitation scale ; postoperative first , third , and seventh day edema ; and ecchymosis were evaluated .
METHODS	Edema and ecchymosis were evaluated using graded scale from 0 to 4 .
RESULTS	Remifentanil reduced mean arterial pressure during the entire operative period and the first 30 minutes postoperatively ( P < 0.05 for these comparisons ) .
RESULTS	Intraoperative bleeding also decreased ( P < 0.001 ) .
RESULTS	There was a significant decrease in edema in both upper and lower eyelid edema on the first and third days in the remifentanil group , although this difference was not detected on the seventh day ( P ( 1upper ) = 0.000 , P ( 1lower ) = 0.000 , P ( 3upper ) = 0.008 , and P ( 3lower ) = 0.002 ) .
RESULTS	Ecchymosis decreased significantly in both upper and lower eyelids on the first , third , and seventh days in the remifentanil group ( P ( 1upper ) = 0.000 , P ( 3upper ) = 0.000 , P ( 3upper ) = 0.002 , P ( 3lower ) = 0.002 , P ( 7upper ) = 0.049 , and P ( 7lower ) = 0.038 ) .
RESULTS	There were no differences in postoperative pain and agitation between 2 groups .
CONCLUSIONS	Remifentanil with controlled hypotension may reduce edema and ecchymosis of the upper and lower eyelids , by reducing mean arterial pressure and amount of bleeding in rhinoplasty .

###24725326
OBJECTIVE	To compare the effectiveness of a single LipiFlow ( ) treatment with combined lid warming and massage in patients with meibomian gland dysfunction ( MGD ) .
METHODS	In this prospective , randomized , crossover , observer-masked clinical trial , subjects were randomized to receive either a single 12-min LipiFlow-LipiFlow Thermal Pulsation ( LTP ) system treatment or to perform combined twice-daily lid warming and massage for 3 months .
METHODS	All subjects were examined before , and 1 and 3 months after initiation of treatments .
METHODS	Investigated parameters included subjective symptoms , lipid layer thickness , meibomian gland assessment , tear break-up time , tear osmolarity , corneal and conjunctival staining , Schirmer test values , and tear meniscus height .
RESULTS	A total of 31 subjects completed the 3-month follow-up .
RESULTS	At 1 and 3 months , patients in the LipiFlow treatment group had a significant reduction in Ocular Surface Disease Index ( OSDI ) scores compared with those in the lid-margin hygiene group .
RESULTS	Both treatments produced a significant improvement in expressible meibomian glands compared to the baseline parameters , but no significant difference was noted between the two groups .
RESULTS	The other investigated objective parameters did not show a significant difference .
CONCLUSIONS	Results of our study show that a single LipiFlow treatment is as least as effective as a 3-month , twice-daily lid margin hygiene regimen for MGD .
CONCLUSIONS	However , the present study was observer-masked only , and therefore a placebo effect may have confounded any improvements in subjective symptoms and other parameters in both groups .

###24842862
OBJECTIVE	To compare prospectively the surgical outcomes of different surgery procedures for convergence insufficiency ( CI ) - type intermittent exotropia ( IXT ) in children .
METHODS	Forty-five children with CI-type IXT were included in this prospective surgical study with 6 months follow-up .
METHODS	According to the different surgical procedures , all children were randomly divided into three groups : the unilateral medial rectus resection ( UMR ) group ( 15 cases ) , the bilateral medial rectus resections ( BMR ) group ( 14 cases ) and the improved unilateral recession-resection ( R&R ) group ( 16 cases ) .
METHODS	In the UMR and BMR groups , the medial rectus resection ( s ) were based on the distance exodeviation .
METHODS	In the R&R group , UMR was based on the near exodeviation while lateral rectus recession was based on the distance exodeviation .
METHODS	A successful surgical alignment was defined as the distant deviation in the primary gaze to be between 10 prism dioptres ( PD ) of exophoria/tropia and 5 PD of esophoria/tropia .
METHODS	The success rate , the preoperative and postoperative deviations at distance and near and near-distance differences among groups were compared .
RESULTS	At the last follow-up of 6 months , the success rate in the R&R ( 87.5 % ) group was significantly higher than those in the UMR ( 13.3 % ) and BMR ( 42.9 % ) groups ( p = 0.000 and 0.008 ) ; the mean exodeviations at distance and near in the R&R group were significantly different from those in the UMR and BMR groups ( p = 0.000 and 0.001 ) ; there were no significant differences in the mean near-distance differences between the R&R group and the other two groups ( p > 0.05 ) .
CONCLUSIONS	The improved R&R procedure in which medial rectus resection based on the near deviation with lateral rectus recession based on the distant deviation has a better alignment than the UMR and BMR surgeries for the treatment of children with CI-type IXT .
CONCLUSIONS	All the UMR , BMR and improved R&R surgery can reduce near-distance differences in children with CI-type IXT .

###24973842
OBJECTIVE	The use of biodegradable-polymer drug-eluting stents has been shown to provide favorable results when compared with durable polymer drug-eluting stents and long-term follow up data have recently shown significant reductions in terms of very late stent thrombosis .
OBJECTIVE	Aim of the present study was to assess the safety and efficacy profile of a novel biodegradable polymer DES , the Yukon Choice Flex sirolimus-eluting stent .
METHODS	We report here the one-year clinical outcomes associated with the use of the Yukon Choice Flex sirolimus-eluting stent in an all-comers patient population .
METHODS	The present stent represents a further refinement of the stent platform tested in the ISAR TEST 3 and 4 randomized clinical trials .
METHODS	A total of 778 consecutive patients undergoing implantation of this stent were enrolled in the present observational study and prospectively followed for one year .
RESULTS	The use of the Yukon Choice Flex stent in a patient population with complex coronary lesion morphology was associated with optimal immediate angiographic results .
RESULTS	At one year follow up the rates of death , myocardial infarction , definite stent thrombosis and ischemia-driven target lesion revascularization were respectively 2.4 % , 1.9 % , 0.3 % and 11.3 % .
CONCLUSIONS	The use of the sirolimus-eluting biodegradable polymer Yukon Choice Flex stent in an all-comers population of patients with complex coronary artery disease is associated with a favorable safety and efficacy profile up to one year follow up .

###25677278
OBJECTIVE	To evaluate the literacy level of patients with glaucoma in a tertiary care teaching centre compared with a rural community centre and to assess comprehension of and preference for educational material written at different reading levels .
METHODS	Prospective , randomized , double-blinded study .
METHODS	Patients with glaucoma presenting for routine examination or referral at a tertiary care academic centre in southwestern Ontario and a single general ophthalmology clinic located in a moderately sized suburban community in Ontario , Canada , were invited to participate in this study .
METHODS	Patients aged 19 to 90 with sufficient visual acuity to read the pamphlets were recruited .
METHODS	Eligible and consenting participants underwent a validated literacy study , and their literacy levels were classified as adequate , barely adequate , marginal , or inadequate .
METHODS	They were then randomized to receive educational pamphlets written at either a grade 5 ( intervention group ) or grade 10 ( control group ) reading level .
METHODS	Comprehension of and preference for the material were determined by analysis of cloze testing and a feedback questionnaire .
RESULTS	Of 199 participants , 179 were included in the analysis .
RESULTS	The literacy testing found that 35 % of patients in the community practice and 30 % in the tertiary care academic centre had `` marginal '' or `` inadequate '' literacy skills , but there was no significant difference between sites ( p = 0.77 ) .
RESULTS	Comprehension of the educational material was higher in the intervention group versus the control group ( p = 0.0057 ) , with a mean cloze score of 57.9 % in the intervention group and 48.3 % in the control group .
RESULTS	The intervention group spent significantly less time reading the pamphlets ( p < 0.0001 ) , with an average of 2.52 minutes compared with 4.51 minutes .
RESULTS	The feedback survey indicated that patients found the pamphlet with the lower reading level easier to read ( p = 0.02 ) , which was reflected in their comments as well .
CONCLUSIONS	In both academic and community practice settings , about 30 % of patients with glaucoma have marginal or inadequate literacy skills .
CONCLUSIONS	However , regardless of practice , all patients better comprehend , and were more receptive to , educational material written at grade 5 reading level with illustrations , regardless of initial literacy level .

###25977276
OBJECTIVE	Patients are classically at risk of delayed cerebral ischemia ( DCI ) after aneurysmal subarachnoid hemorrhage .
OBJECTIVE	We validated a grading scale-the VASOGRADE-for prediction of DCI .
METHODS	We used data of 3 phase II randomized clinical trials and a single hospital series to assess the relationship between the VASOGRADE and DCI .
METHODS	The VASOGRADE derived from previously published risk charts and consists of 3 categories : VASOGRADE-Green ( modified Fisher scale 1 or 2 and World Federation of Neurosurgical Societies scale [ WFNS ] 1 or 2 ) ; VASOGRADE-Yellow ( modified Fisher 3 or 4 and WFNS 1-3 ) ; and VASOGRADE-Red ( WFNS 4 or 5 , irrespective of modified Fisher grade ) .
METHODS	The relation between the VASOGRADE and DCI was assessed by logistic regression models .
METHODS	The predictive accuracy of the VASOGRADE was assessed by receiver operating characteristics curve and calibration plots .
RESULTS	In a cohort of 746 patients , the VASOGRADE significantly predicted DCI ( P < 0.001 ) .
RESULTS	The VASOGRADE-Yellow had a tendency for increased risk for DCI ( odds ratio [ OR ] , 1.31 ; 95 % CI , 0.77-2 .23 ) when compared with VASOGRADE-Green ; those with VASOGRADE-Red had a 3-fold higher risk of DCI ( OR , 3.19 ; 95 % CI , 2.07-4 .50 ) .
RESULTS	Studies were not a significant confounding factor between the VASOGRADE and DCI .
RESULTS	The VASOGRADE had an adequate discrimination for prediction of DCI ( area under the receiver operating characteristics curve = 0.63 ) and good calibration .
CONCLUSIONS	The VASOGRADE results validated previously published risk charts in a large and diverse sample of subarachnoid hemorrhage patients , which allows DCI risk stratification on presentation after subarachnoid hemorrhage .
CONCLUSIONS	It could help to select patients at high risk of DCI , as well as standardize treatment protocols and research studies .

###24768239
OBJECTIVE	To determine the effect of suppression of vascular endothelial growth factor ( VEGF ) by monthly injection of ranibizumab on posterior retinal nonperfusion ( RNP ) in patients with diabetic macular edema ( DME ) .
METHODS	Unplanned retrospective analysis of prospectively collected data from 2 randomized , sham injection-controlled , double-masked , multicenter clinical trials .
METHODS	Six hundred sixty-six patients with DME .
METHODS	An independent reading center measured the area of RNP on fluorescein angiograms obtained in the phase 3 RISE and RIDE trials .
METHODS	The percentage of patients with no posterior RNP .
RESULTS	The percentage of patients with no posterior RNP decreased in the sham group between baseline and month 24 , but remained relatively stable in the 2 ranibizumab groups .
RESULTS	After month 24 , the sham group crossed over to receive monthly injections of ranibizumab 0.5 mg , and the differences between the sham and ranibizumab groups were reduced .
RESULTS	The percentage of patients who showed an increase in posterior RNP from baseline increased over time in all 3 groups , but at a faster rate in the sham group , resulting in statistically significant differences at every time point between months 3 ( 9.6 % vs. 18.5 % ; P = 0.016 ) and 24 ( 16.1 % vs. 37.6 % ; P < 0.0001 ) for ranibizumab 0.5 mg versus sham and from months 6 ( 12.3 % vs. 23.0 % ; P = 0.013 ) through 24 ( 15.0 % vs. 37.6 % ; P < 0.0001 ) for ranibizumab 0.3 mg .
RESULTS	Initiation of ranibizumab in the sham group at month 24 was followed by reduction in the percentage of patients with an increase in posterior RNP from baseline at months 30 and 36 , whereas the 2 ranibizumab groups continued their gradual rise .
CONCLUSIONS	Just as high VEGF levels contribute to progression of retinal nonperfusion in retinal vein occlusion , the same is true in patients with DME , suggesting that regardless of the underlying disease process , high levels of VEGF can cause closure of retinal vessels .
CONCLUSIONS	However , our data also suggest that VEGF-induced worsening of retinal perfusion in DME is superimposed on another cause of more gradually worsening perfusion , possibly glucotoxicity .
CONCLUSIONS	Thus , monthly injections of ranibizumab can slow , but not completely prevent , retinal capillary closure in patients with DME .

###24550184
OBJECTIVE	To assess the efficacy of combined use of scorpion antivenom ( SAV ) with prazosin , compared with prazosin alone in children with Mesobuthus tamulus scorpion envenomation .
METHODS	Randomised controlled trial .
METHODS	A tertiary care hospital in south India .
METHODS	50 children with definite history and/or systemic manifestations of scorpion envenomation were recruited from the paediatric emergency or outpatient department from February 2012 to July 2013 .
METHODS	The children were randomised into two groups .
METHODS	In 25 children , SAV was administrated as a slow intravenous bolus combined with prazosin ( group A ) .
METHODS	Others received prazosin alone ( group B ) .
METHODS	Results were analysed by Student t test and ( 2 ) test .
METHODS	Time required for resolution of autonomic symptoms , total dose of prazosin , adverse events .
RESULTS	Children in group A recovered earlier than those in group B ( mean difference 9.1 h , 95 % CI 6.0 to 12.2 ) .
RESULTS	23 children ( 92 % ) in group A were clear of autonomic symptoms within 10h , compared with 10 children ( 40 % ) in group B ( mean difference 52 % , 95 % CI 29 % to 75 % ) .
RESULTS	The proportion of children deteriorating to clinical grade 3 or 4 was 8 % in group A as against 44 % in group B ( p < 0.01 ) .
RESULTS	The mean dose of prazosin required was 54g/kg versus 130.8 g/kg in group A and B , respectively ( p < 0.01 ) .
RESULTS	SAV was not associated with severe adverse reactions .
CONCLUSIONS	Usage of SAV led to faster recovery and reduced the incidence of myocardial dysfunction .
CONCLUSIONS	Combined therapy with SAV and prazosin is beneficial for children with M tamulus scorpion envenomation .
BACKGROUND	CTRI/2013/09 / 004002 ( Clinical Trials Registry of India ) .

###24754974
BACKGROUND	Continuous feedback on patient improvement and the therapeutic alliance may reduce the number of dropouts and increase patient outcome .
BACKGROUND	There are , however , only three published randomized trials on the effect of feedback on the treatment of eating disorders , showing inconclusive results , and there are no randomized trials on the effect of feedback in group therapy .
BACKGROUND	Accordingly the current randomized clinical trial , initiated in September 2012 at the outpatient clinic for eating disorders at Stolpegaard Psychotherapy Centre , aims to investigate the impact of continuous feedback on attendance and outcome in group psychotherapy .
METHODS	The hypothesis is that continuous feedback to both patient and therapist on treatment progress and alliance will increase attendance and treatment outcome .
METHODS	The trial is set up using a randomized design with a minimum of 128 patients allocated to either an experimental or control group at a ratio of 1:1 .
METHODS	The experimental group will receive standard treatment ( systemic and narrative group psychotherapy ) with feedback intervention , whereas the control group will receive standard treatment only .
METHODS	The participants are diagnosed with bulimia nervosa , binge eating disorder , or an eating disorder not otherwise specified , according to the DSM-IV .
METHODS	In the experimental group feedback to the participants , based on the Outcome Rating Scale ( ORS ) and the Group Session Rating Scale ( GSRS ) , is actively added to standard treatment .
METHODS	The ORS assesses areas of life functioning known to change as a result of therapeutic intervention .
METHODS	The GSRS assesses key dimensions of effective therapeutic relationships .
METHODS	In the control group , the patients fill out the Outcome Rating Scale only , and feedback is not provided.The primary outcome is the rate of attendance to treatment sessions .
METHODS	The secondary outcome is the severity of eating disorder symptoms .
METHODS	Exploratory outcomes are the level of psychological and social functioning , and suicide or self-harm .
METHODS	This is measured with the ORS , Symptom Check List , WHO-Five Wellbeing Index , Sheehan Disability Scale and a modified version of the Self-Harm Inventory .
CONCLUSIONS	If the results will confirm the hypothesis , this trial will support feedback as a way to improve group treatment attendance for outpatients with eating disorders .
BACKGROUND	ClinicalTrials.gov identifier : NCT01693237 .

###24324573
BACKGROUND	Hepatitis B virus ( HBV ) infection is endemic in South Africa however , there is limited data on the degree of liver disease and geographic variation in HIV/HBV coinfected individuals .
BACKGROUND	In this study , we analysed data from the CIPRA-SA ` Safeguard the household study ' in order to assess baseline HBV characteristics in HIV/HBV co-infection participants prior to antiretroviral therapy ( ART ) initiation .
METHODS	812 participants from two South African townships Soweto and Masiphumelele were enrolled in a randomized trial of ART ( CIPRA-SA ) .
METHODS	Participants were tested for hepatitis B surface antigen ( HBsAg ) , hepatitis B e antigen ( HBeAg ) , and HBV DNA .
METHODS	FIB-4 scores were calculated at baseline .
RESULTS	Forty-eight ( 5.9 % ) were HBsAg positive , of whom 28 ( 58.3 % ) were HBeAg positive .
RESULTS	Of those with HBV , 29.8 % had an HBV DNA < 2000 IU/ml and ALT < 40 IU/ml ; 83.0 % had a FIB-4 score < 1.45 , consistent with absent or minimal liver disease .
RESULTS	HBV prevalence was 8.5 % in Masiphumelele compared to 3.8 % in Soweto ( relative risk 2.3 ; 95 % CI : 1.3-4 .0 ) .
RESULTS	More participants in Masiphumelele had HBeAg-negative disease ( 58 % vs. 12 % , p = 0.002 ) and HBV DNA levels 2000 IU/ml , ( 43 % vs. 6 % p < 0.007 ) .
CONCLUSIONS	One third of HIV/HBV co-infected subjects had low HBV DNA levels and ALT while the majority had indicators of only mild liver disease .
CONCLUSIONS	There were substantial regional differences in HBsAg and HbeAg prevalence in HIV/HBV co-infection between two regions in South Africa .
CONCLUSIONS	This study highlights the absence of severe liver disease and the marked regional differences in HIV/HBV co-infection in South Africa and will inform treatment decisions in these populations .

###25474418
OBJECTIVE	The aim of this research is to explore the coupling patterns of brain dynamics during an auditory oddball task in schizophrenia ( SCH ) .
METHODS	Event-related electroencephalographic ( ERP ) activity was recorded from 20 SCH patients and 20 healthy controls .
METHODS	The coupling changes between auditory response and pre-stimulus baseline were calculated in conventional EEG frequency bands ( theta , alpha , beta-1 , beta-2 and gamma ) , using three coupling measures : coherence , phase-locking value and Euclidean distance .
RESULTS	Our results showed a statistically significant increase from baseline to response in theta coupling and a statistically significant decrease in beta-2 coupling in controls .
RESULTS	No statistically significant changes were observed in SCH patients .
CONCLUSIONS	Our findings support the aberrant salience hypothesis , since SCH patients failed to change their coupling dynamics between stimulus response and baseline when performing an auditory cognitive task .
CONCLUSIONS	This result may reflect an impaired communication among neural areas , which may be related to abnormal cognitive functions .

###24736094
OBJECTIVE	To determine whether a health-promotion intervention increases South African men 's adherence to physical-activity guidelines .
METHODS	We utilized a cluster-randomized controlled trial design .
METHODS	Eligible clusters , residential neighborhoods near East London , South Africa , were matched in pairs .
METHODS	Within randomly selected pairs , neighborhoods were randomized to theory-based , culturally congruent health-promotion intervention encouraging physical activity or attention-matched HIV/STI risk-reduction control intervention .
METHODS	Men residing in the neighborhoods and reporting coitus in the previous 3 months were eligible .
METHODS	Primary outcome was self-reported individual-level adherence to physical-activity guidelines averaged over 6-month and 12-month post-intervention assessments .
METHODS	Data were collected in 2007-2010 .
METHODS	Data collectors , but not facilitators or participants , were blind to group assignment .
RESULTS	Primary outcome intention-to-treat analysis included 22 of 22 clusters and 537 of 572 men in the health-promotion intervention and 22 of 22 clusters and 569 of 609 men in the attention-control intervention .
RESULTS	Model-estimated probability of meeting physical-activity guidelines was 51.0 % in the health-promotion intervention and 44.7 % in attention-matched control ( OR = 1.34 ; 95 % CI , 1.09-1 .63 ) , adjusting for baseline prevalence and clustering from 44 neighborhoods .
CONCLUSIONS	A theory-based culturally congruent intervention increased South African men 's self-reported physical activity , a key contributor to deaths from non-communicable diseases in South Africa .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01490359 .

###24678649
OBJECTIVE	The aim of the current study was to determine any relationship between the timing of clamping of the umbilical cord and the lipid levels circulating in umbilical artery and vein .
METHODS	We studied a clinical trial with systematic assignment in 229 single-fetus full-term deliveries with normal gestational course and spontaneous delivery ; out of these , 111 were subjected to early clamping ( EC , within 10 s of delivery ) and 118 to late clamping ( LC , at 2 min ) .
METHODS	In all cases , total cholesterol ( TC ) , triglycerides ( TG ) , and phospholipids were measured in sera from umbilical artery and vein .
RESULTS	TC and TG values were significantly higher in the EC group than in the LC group in both umbilical artery and vein .
RESULTS	Comparing values between umbilical artery and vein in the two clamping groups , in the EC group , all studied lipids TC , TG and phospholipids were significantly higher in vein than in artery .
RESULTS	In the LC group , only TC was higher in vein .
CONCLUSIONS	Umbilical cord lipid levels are related to the timing of umbilical cord clamping , finding which is noteworthy , because they are essential component of postnatal development .
CONCLUSIONS	Our study confirms that delivery acts as an important modifier of fetal lipid levels .

###24606873
BACKGROUND	Attrition is common in the treatment of anorexia nervosa and its causes are complex and incompletely understood .
BACKGROUND	In particular , its relationship with adaptive function and motivational stage of change has been little studied .
BACKGROUND	This study aimed to ( 1 ) investigate and ( 2 ) compare the strength of associations between adaptive function , stage of change and other previously found factors such as illness sub-type and treatment attrition in women with severe and enduring anorexia nervosa ( SE-AN ) .
METHODS	Participants were 63 adult women with SE-AN of at least 7 years duration who were enrolled in a multi-site randomized controlled trial conducted from July 2007 through June 2011 .
METHODS	Treatment comprised 30 outpatient visits over 8 months of either Cognitive Behaviour Therapy for Anorexia Nervosa ( CBT-AN ) or Specialist Supportive Clinical Management ( SSCM ) both of which were modified for severe and enduring illness .
METHODS	Assessments were done at baseline , end of treatment , and 6 and 12 month post treatment follow-up .
METHODS	Demographic variables , duration of illness , specific and generic health related quality of life ( QoL ) , eating disorder ( ED ) and mood disorder symptoms , social adjustment , body mass index ( BMI ) , and motivation for change were assessed with interview and self-report questionnaires .
METHODS	Treatment attrition was defined as leaving therapy after either premature termination according to trial protocol or self-instigated discharge .
METHODS	Binary logistic regression was used to investigate relative strength of associations .
RESULTS	Those who did not complete treatment were significantly more likely to have the purging sub-type of anorexia nervosa and poorer ED related QoL .
RESULTS	There were no significant differences between attrition and which therapy was received , educational level , and global ED psychopathology , stage of change , BMI , social adjustment , duration of illness or level of depression .
RESULTS	The strongest predictors on multivariable analysis were ED QoL and AN-purging subtype .
CONCLUSIONS	This study supported previous findings of associations between attrition and purging subtype .
CONCLUSIONS	Furthermore , we found associations between a potentially important cycle of attrition , and poorer EDQoL , which has not been previously reported .
CONCLUSIONS	Contrary to expectations we did not find an association with BMI , severity of ED symptoms , low level of motivation to change ED features , or level of education .

###25589559
OBJECTIVE	Recent evidence supports the use of normal saline flushes in place of heparin to maintain the patency of peripheral intravenous locks ( IVLs ) ; however , there are no data regarding the recommended flush frequency .
METHODS	This was an open , non-inferiority , randomised controlled trial .
METHODS	Children with IVLs , aged 1-17 years , were randomly assigned to receive saline flushing every 12 h ( group A ) or every 24 h ( group B ) .
METHODS	The main outcome was the maintenance of catheter patency .
RESULTS	Four hundred patients were randomised ; 198 subjects were analysed in the 12 h group and 199 in the 24 h group ( three patients were lost at follow-up ) .
RESULTS	Occlusion occurred in 15 children ( 7.6 % ) in group A versus 9 ( 4.5 % ) in group B ( p = 0.21 ) .
RESULTS	The difference in catheter patency was +3.1 % in favour of the 24 h group ( 95 % CI -1.6 % to 7.7 % ) , showing the non-inferiority of the 24 h procedure ( the non-inferiority margin was set at -4 % ) .
RESULTS	Catheter-related complications were not different between the two groups ( 12.1 % in group A vs 9.5 % in group B ; p = 0.42 ) .
CONCLUSIONS	A flushing procedure with one flush per day allows maintenance of catheter patency without an increase in catheter-related complications .
CONCLUSIONS	We propose a simplification of the flushing procedure with only one flush per day , thereby reducing costs ( materials use and nursing time ) , labour and unnecessary manipulation of the catheters which can cause distress in younger children and their parents .
BACKGROUND	The study is registered in the international database ClinicalTrial.gov under registration number NCT02221024 .

###24449243
OBJECTIVE	The benefits of chemoradiotherapy ( CRT ) for cervical cancer compared with radiation ( RT ) alone seem to diminish in later-stage disease .
OBJECTIVE	However , these modalities have not been directly compared for disease-free interval ( DFI ) and overall survival ( OS ) of women with stage IIIB cervical cancer .
METHODS	We conducted a randomized controlled clinical trial comparing DFI and OS of 147 women with stage IIIB squamous cervical cancer who received either cisplatin plus RT ( CRT ) or RT alone ( 72 patients in the CRT group and 75 patients in the RT-only group ) .
RESULTS	The CRT group had significantly better DFI ( hazard ratio [ HR ] , 0.52 ; 95 % CI , 0.29 to 0.93 ; P = .02 ) .
RESULTS	However , patients in the CRT group did not have significantly better OS than those in the RT-only group ( HR , 0.67 ; 95 % CI , 0.38 to 1.17 ; P = .16 ) .
RESULTS	Toxicity was graded according to criteria of the Radiation Therapy Oncology Group .
RESULTS	The organs affected ( excluding hematologic effects ) did not differ significantly between groups .
RESULTS	Also , late toxicity events and organs affected were not significantly disproportionate between the study groups .
CONCLUSIONS	For stage IIIB cervical cancer , the addition of cisplatin offers a small but significant benefit in DFI , with acceptable toxicity .

###24599947
OBJECTIVE	Attention-based coping strategies for pain are widely used in pediatric populations .
OBJECTIVE	The purpose of this study was to test a novel mindful attention manipulation on adolescent 's experimental pain responses .
OBJECTIVE	Furthermore , the relationship between state mindfulness and experimental pain was examined .
METHODS	A total of 198 adolescents were randomly assigned to a mindful attention manipulation or control group prior to an experimental pain task .
METHODS	Participants completed measures of state mindfulness immediately prior to the pain task , and situational catastrophizing and pain intensity following the task .
RESULTS	Overall the manipulation had no effect on pain .
RESULTS	Secondary analysis showed that meditation experience moderated the effect of the manipulation .
RESULTS	State mindfulness predicted pain outcomes , with reductions in situational catastrophizing mediating this relationship .
CONCLUSIONS	The mindful attention manipulation was effective among adolescents with a regular meditation practice .
CONCLUSIONS	State mindfulness was related to ameliorated pain responses , and these effects were mediated by reduced catastrophizing .

###25398661
OBJECTIVE	To evaluate the astigmatic effects of 2.2-mm and 1.8-mm cataract incisions .
METHODS	A randomized prospective study of 190 eyes of 151 patients undergoing superior clear corneal incision ( SCCI ) was divided into three groups : 61 eyes with a control 3.2-mm SCCI ; 66 eyes with a 2.2-mm SCCI ; and 63 eyes with a 1.8-mm SCCI .
METHODS	The corneal astigmatism was measured with an autokeratometer preoperatively and 1month after surgery .
METHODS	The with-the-wound ( WTW ) , against the-wound ( ATW ) , and WTW-ATW changes were calculated using the Holladay-Cravy-Koch formula .
RESULTS	The WTW , ATW , and WTW-ATW changes were significantly higher for the control 3.2-mm SCCI than for the 2.2 - and 1.8-mm SCCI ( all p < 0.001 ) , and no difference was found between the 2.2 - and 1.8-mm SCCI incision groups .
CONCLUSIONS	In our study , the astigmatic effects were the same for the 2.2 mm and 1.8 mm incisions and as expected , were significantly lower than the control 3.2 mm incision group .

###24871477
BACKGROUND	Vegetarian diets have been associated with reduced mortality .
BACKGROUND	Because a pure vegetarian diet might not easily be embraced by many individuals , consuming preferentially plant-derived foods would be a more easily understood message .
BACKGROUND	A provegetarian food pattern ( FP ) emphasizing preference for plant-derived foods might reduce all-cause mortality .
OBJECTIVE	The objective was to identify the association between an a priori-defined provegetarian FP and all-cause mortality .
METHODS	We followed 7216 participants ( 57 % women ; mean age : 67 y ) at high cardiovascular risk for a median of 4.8 y.
METHODS	A validated 137-item semiquantitative food-frequency questionnaire was administered at baseline and yearly thereafter .
METHODS	Fruit , vegetables , nuts , cereals , legumes , olive oil , and potatoes were positively weighted .
METHODS	Added animal fats , eggs , fish , dairy products , and meats or meat products were negatively weighted .
METHODS	Energy-adjusted quintiles were used to assign points to build the provegetarian FP ( range : 12-60 points ) .
METHODS	Deaths were confirmed by review of medical records and the National Death Index .
RESULTS	There were 323 deaths during the follow-up period ( 76 from cardiovascular causes , 130 from cancer , 117 for noncancer , noncardiovascular causes ) .
RESULTS	Higher baseline conformity with the provegetarian FP was associated with lower mortality ( multivariable-adjusted HR for 40 compared with < 30 points : 0.59 ; 95 % CI : 0.40 , 0.88 ) .
RESULTS	Similar results were found with the use of updated information on diet ( RR : 0.59 ; 95 % CI : 0.39 , 0.89 ) .
CONCLUSIONS	Among omnivorous subjects at high cardiovascular risk , better conformity with an FP that emphasized plant-derived foods was associated with a reduced risk of all-cause mortality .
CONCLUSIONS	This trial was registered at www.controlled-trials.com as ISRCTN35739639 .

###24463982
OBJECTIVE	This study aims to compare the effects of a mandibular advancement device ( MAD ) with continuous positive airway pressure ( CPAP ) treatment for obstructive sleep apnea ( OSA ) on blood pressure ( BP ) , oxidative stress , and heart rate variability ( HRV ) in a randomized , crossed-over , single-blind , and controlled trial .
METHODS	Twenty-nine moderate-to-severe adult OSA patients underwent MAD , CPAP , and placebo oral appliance treatment .
METHODS	Polysomnography , Epworth sleepiness scale , 24-h ambulatory BP monitoring , oxidative stress parameters ( malondialdehyde , catalase , superoxide dismutase , vitamins C , E , B6 , B12 , folate , homocysteine , uric acid ) , and HRV were assessed at baseline and after 1month of each treatment .
METHODS	Diaries were used to evaluate compliance for devices and a pressure-time meter for CPAP .
RESULTS	Both active treatments resulted in decreases in apnea and hypopnea index and Epworth sleepiness scale ; CPAP showed a greater effect .
RESULTS	Frequency of diastolic BP dipping was higher in the MAD group compared with the CPAP group .
RESULTS	A significant drop from baseline levels for catalase activity was observed after MAD .
RESULTS	For HRV , there was a significant decrease in total power at night with CPAP and MAD compared with POA , and a decrease in index of sleep autonomic variation with MAD compared with baseline levels .
RESULTS	Compliance rates were higher with MAD rather than CPAP .
CONCLUSIONS	Even though CPAP proved to be more effective at attenuating OSA , better compliance with MAD favored the reduction of one of the enzymes which participates in oxidative stress and better autonomic modulation during sleep .

###25502058
BACKGROUND	People using long-term indwelling urinary catheters experience multiple recurrent catheter problems .
BACKGROUND	Self-management approaches are needed to avoid catheter-related problems .
OBJECTIVE	The aim was to determine effectiveness of a self-management intervention in prevention of adverse outcomes ( catheter-related urinary tract infection , blockage , and accidental dislodgement ) .
OBJECTIVE	Healthcare treatment associated with the adverse outcomes and catheter-related quality of life was also studied .
METHODS	A randomized clinical trial was conducted .
METHODS	The intervention involved learning catheter-related self-monitoring and self-management skills during home visits by a study nurse ( twice during the first month and at 4 months-with a phone call at 2 months ) .
METHODS	The control group received usual care .
METHODS	Data were collected during an initial face-to-face home interview followed by bimonthly phone interviews .
METHODS	A total of 202 adult long-term urinary catheter users participated .
METHODS	Participants were randomized to treatment or control groups following collection of baseline data .
METHODS	Generalized estimating equations were used for the analysis of treatment effect .
RESULTS	In the intervention group , there was a significant decrease in reported blockage in the first 6 months ( p = .02 ) , but the effect did not persist .
RESULTS	There were no significant effects for catheter-related urinary tract infection or dislodgment .
RESULTS	Comparison of baseline rates of adverse outcomes with subsequent periods suggested that both groups improved over 12 months .
CONCLUSIONS	A simple-to-use catheter problems calendar and the bimonthly interviews might have functioned as a modest self-monitoring intervention for persons in both groups .
CONCLUSIONS	A simplified intervention using a self-monitoring calendar is suggested-with optimal and consistent fluid intake likely to add value .

###24475777
BACKGROUND	A 6-month phase 2 study of fingolimod demonstrated efficacy and safety in Japanese patients with relapsing-remitting multiple sclerosis ( MS ) .
BACKGROUND	Here we report a 6-month observational extension that evaluated efficacy and safety in patients who received fingolimod continuously for 12 months or who switched from placebo to fingolimod .
METHODS	Of 147 patients who completed the 6-month core study , 143 entered the extension .
METHODS	Those originally randomized to placebo were re-randomized to fingolimod 1.25 mg or 0.5 mg .
METHODS	During the extension , all patients were switched to open-label fingolimod 0.5 mg .
RESULTS	Magnetic resonance imaging ( MRI ) and relapse outcomes were maintained or improved in patients treated with fingolimod for 12 months versus those treated for 6 months .
RESULTS	No new safety events were reported over 12 months of treatment .
RESULTS	Infections occurred in similar proportions of continuously treated and switched patients , while cardiac and liver adverse events occurred in fewer continuously treated than switched patients .
RESULTS	Four patients were aquaporin-4 ( AQP4 ) antibody-positive , three of whom showed rapid disease exacerbations within 10 days of fingolimod initiation .
CONCLUSIONS	Continuous fingolimod treatment for up to 12 months was associated with maintained or improved efficacy and a manageable safety profile , consistent with that previously seen .
CONCLUSIONS	Results in a small number of patients suggest lack of benefit in AQP4 antibody-positive patients .
CONCLUSIONS	Meaningful statistical interpretation was limited by the small sample size in each treatment group , owing to the number of patients who completed the core study .
BACKGROUND	ClinicalTrials.gov NCT00670449 .

###24613024
BACKGROUND	Monochorionic twin pregnancies complicated by twin-to-twin transfusion syndrome are typically treated with fetoscopic laser coagulation .
BACKGROUND	Postoperative complications can occur due to residual vascular anastomoses on the placenta .
BACKGROUND	We aimed to assess the efficacy and safety of a novel surgery technique that uses laser coagulation of the entire vascular equator ( Solomon technique ) .
METHODS	We undertook an open-label , international , multicentre , randomised controlled trial at five European tertiary referral centres .
METHODS	Women with twin-to-twin transfusion syndrome were randomly assigned by online randomisation ( 1:1 ) with permuted blocks to the Solomon technique or standard laser coagulation .
METHODS	The primary outcome was a composite of incidence of twin anaemia polycythaemia sequence , recurrence of twin-to-twin transfusion syndrome , perinatal mortality , or severe neonatal morbidity .
METHODS	Analyses were by intention to treat , with results expressed as odds ratios ( ORs ) and 95 % CIs .
METHODS	This trial is registered with the Dutch Trial Registry , number NTR1245 .
RESULTS	Between March 11 , 2008 , and July 12 , 2012 , 274 women were randomly assigned to either the Solomon group ( n = 139 ) or the standard treatment group ( n = 135 ) .
RESULTS	The primary outcome occurred in 94 ( 34 % ) of 274 fetuses in the Solomon group versus 133 ( 49 % ) of 270 in the standard treatment group ( OR 054 ; 95 % CI 035-082 ) .
RESULTS	The Solomon technique was associated with a reduction in twin anaemia polycythaemia sequence ( 3 % vs 16 % for the standard treatment ; OR 016 , 95 % CI 005-049 ) and recurrence of twin-to-twin transfusion syndrome ( 1 % vs 7 % ; 021 , 004-098 ) .
RESULTS	Perinatal mortality and severe neonatal morbidity did not differ significantly between the two groups .
RESULTS	Outside of the common and well-known complications of twin-to-twin transfusion syndrome and its treatment , no serious adverse events occurred .
CONCLUSIONS	Fetoscopic laser coagulation of the entire vascular equator reduces postoperative fetal morbidity in severe twin-to-twin transfusion syndrome .
CONCLUSIONS	We recommend that fetoscopic surgeons consider adopting this strategy for treatment of women with twin-to-twin transfusion syndrome .
BACKGROUND	Netherlands Organization for the Health Research and Development ( ZonMw 92003545 ) .

###24885542
BACKGROUND	Many smokers find the cost of smoking cessation medications a barrier .
BACKGROUND	Financial coverage for these medications increases utilization of pharmacotherapies .
BACKGROUND	This study assesses whether financial coverage increases the proportion of successful quitters .
METHODS	A pragmatic , open-label , randomized , controlled trial was conducted in 58 Canadian sites between March 2009 and September 2010 .
METHODS	Smokers ( 10 cigarettes/day ) without insurance coverage who were motivated to quit within 14days were randomized ( 1:1 ) in a blinded manner to receive either full coverage eligibility for 26weeks or no coverage .
METHODS	Pharmacotherapies covered were varenicline , bupropion , or nicotine patches/gum .
METHODS	Investigators/subjects were unblinded to study group assignment after randomization and prior to choosing a smoking cessation method ( s ) .
METHODS	All subjects received brief smoking cessation counseling .
METHODS	The primary outcome measure was self-reported 7-day point prevalence of abstinence ( PPA ) at week 26 .
RESULTS	Of the 1380 randomized subjects ( coverage , 696 ; no coverage , 684 ) , 682 ( 98.0 % ) and 435 ( 63.6 % ) , respectively , were dispensed at least one smoking cessation medication dose .
RESULTS	The 7-day PPA at week 26 was higher in the full coverage versus no coverage group : 20.8 % ( n = 145 ) and 13.9 % ( n = 95 ) , respectively ; odds ratio ( OR ) = 1.64 , 95 % confidence interval ( CI ) 1.23-2 .18 ; p = 0.001 .
RESULTS	Urine cotinine-confirmed 7-day PPA at week 26 was 15.7 % ( n = 109 ) and 10.1 % ( n = 69 ) , respectively ; OR = 1.68 , 95 % CI 1.21-2 .33 ; p = 0.002 .
RESULTS	After pharmacotherapy , coverage eligibility was withdrawn from the full coverage group , continuous abstinence between weeks 26 and 52 was 6.6 % ( n = 46 ) and 5.6 % ( n = 38 ) , in the full coverage and no coverage groups , respectively ; OR = 1.19 , 95 % CI 0.76-1 .87 ; p = 0.439 .
CONCLUSIONS	In this study , the adoption of a smoking cessation medication coverage drug policy was an effective intervention to improve 26-week quit rates in Canada .
CONCLUSIONS	The advantages were lost once coverage was discontinued .
CONCLUSIONS	Further study is required on the duration of coverage to prevent relapse to smoking .
CONCLUSIONS	( clinicaltrials.gov identifier : NCT00818207 ; the study was sponsored by Pfizer Inc. ) .

###24655157
OBJECTIVE	To analyze bereaved next of kin 's suggestions for improving end-of-life ( EOL ) care in Veterans Affairs ( VA ) Medical Centers ( VAMCs ) .
METHODS	Qualitative .
METHODS	This study was part of a larger study testing the effectiveness of a multimodal intervention strategy to improve processes of EOL care in six southeast U.S. VAMCs ( Best Practices for End-of-Life Care for Our Nation 's Veterans-BEACON Trial ) .
METHODS	Bereaved next of kin ( n = 78 ) of veterans who died between 2005 and 2010 .
METHODS	Data addressing praise , criticism , and recommendations for enhancing EOL care were abstracted from semistructured interviews of next of kin and aggregated into a code labeled `` Suggestions . ''
METHODS	Content analysis proceeded iteratively through data review , comparison , and negotiation of emergent themes and integration of all coauthors ' insights and interpretations into the evolving interpretive scheme .
RESULTS	Next of kin provided examples that resonated with their conceptions of quality EOL care .
RESULTS	They also described distressing situations and perceptions of deficits in care .
RESULTS	Major themes derived were compassionate care , good communication , support for family visits and privacy , and the need for death preparation and postdeath guidance .
RESULTS	The fifth theme , unique to this study , was the salience of the relationship between the veterans and their families and the VA and the expectations this engendered in terms of dignity and honor .
CONCLUSIONS	Interventions that support staff 's ability to convey compassion , communicate information to families and other staff , listen to patients and families , prepare families for the individual 's death , and provide consistent , coordinated information regarding after-death activities may optimize EOL hospital care for veterans .

###25800753
OBJECTIVE	Trials in castration-resistant prostate cancer ( CRPC ) need new clinical end points that are valid surrogates for survival .
OBJECTIVE	We evaluated circulating tumor cell ( CTC ) enumeration as a surrogate outcome measure .
METHODS	Examining CTCs alone and in combination with other biomarkers as a surrogate for overall survival was a secondary objective of COU-AA-301 , a multinational , randomized , double-blind phase III trial of abiraterone acetate plus prednisone versus prednisone alone in patients with metastatic CRPC previously treated with docetaxel .
METHODS	The biomarkers were measured at baseline and 4 , 8 , and 12 weeks , with 12 weeks being the primary measure of interest .
METHODS	The Prentice criteria were applied to test candidate biomarkers as surrogates for overall survival at the individual-patient level .
RESULTS	A biomarker panel using CTC count and lactate dehydrogenase ( LDH ) level was shown to satisfy the four Prentice criteria for individual-level surrogacy .
RESULTS	Twelve-week surrogate biomarker data were available for 711 patients .
RESULTS	The abiraterone acetate plus prednisone and prednisone-alone groups demonstrated a significant survival difference ( P = .034 ) ; surrogate distribution at 12 weeks differed by treatment ( P < .001 ) ; the discriminatory power of the surrogate to predict mortality was high ( weighted c-index , 0.81 ) ; and adding the surrogate to the model eliminated the treatment effect on survival .
RESULTS	Overall , 2-year survival of patients with CTCs < 5 ( low risk ) versus patients with CTCs 5 cells/7 .5 mL of blood and LDH > 250 U/L ( high risk ) at 12 weeks was 46 % and 2 % , respectively .
CONCLUSIONS	A biomarker panel containing CTC number and LDH level was shown to be a surrogate for survival at the individual-patient level in this trial of abiraterone acetate plus prednisone versus prednisone alone for patients with metastatic CRPC .
CONCLUSIONS	Additional trials are ongoing to validate the findings .

###24652410
BACKGROUND	Pulmonary edema may alter alveolar bacterial clearance and infectivity .
BACKGROUND	Manipulation of fluid balance aimed at reducing fluid overload may , therefore , influence ventilator-associated pneumonia ( VAP ) occurrence in intubated patients .
BACKGROUND	The objective of the present study was to assess the impact of a depletive fluid-management strategy on ventilator-associated complication ( VAC ) and VAP occurrence during weaning from mechanical ventilation .
METHODS	We used data from the B-type Natriuretic Peptide for the Fluid Management of Weaning ( BMW ) randomized controlled trial performed in nine ICUs across Europe and America .
METHODS	We compared the cumulative incidence of VAC and VAP between the biomarker-driven , depletive fluid-management group and the usual-care group during the 14 days following randomization , using specific competing-risk methods ( the Fine and Gray model ) .
RESULTS	Among the 304 patients analyzed , 41 experienced VAP , including 27 ( 17.8 % ) in the usual-care group vs 14 ( 9.2 % ) in the interventional group ( P = .03 ) .
RESULTS	From the Fine and Gray model , the probabilities of VAC and VAP occurrence were both significantly reduced with the interventional strategy while adjusting for weaning outcome as a competing event ( subhazard ratios [ 25th-75th percentiles ] , 0.44 [ 0.22-0 .87 ] , P = .02 and 0.50 [ 0.25-0 .96 ] , P = .03 , respectively ) .
CONCLUSIONS	Using proper competing risk analyses , we found that a depletive fluid-management strategy , when initiating the weaning process , has the potential for lowering VAP risk in patients who are mechanically ventilated .
BACKGROUND	ClinicalTrials.gov ; No. : NCT00473148 ; URL : www.clinicaltrials.gov .

###25406967
BACKGROUND	Despite the potential benefits of long-chain n-3 polyunsaturated fatty acids ( LC n-3 PUFAs ) , intake is often low because of low consumption of oily seafood .
BACKGROUND	Microencapsulated fish oil powder can improve tolerance and acceptance of LC n-3 PUFAs .
BACKGROUND	Bioavailability is important to achieve efficacy .
BACKGROUND	We investigated the bioavailability of LC n-3 PUFAs from microencapsulated powder in comparison with meals enriched with liquid fish oil .
METHODS	Participants ( N = 99 , age50 years ) of this 4-week double-blinded dietary intervention were randomized into three groups .
METHODS	Group 1 ( n = 38 ) received 1.5 g/d eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) as ready-to-eat meals enriched with liquid fish oil ; group 2 ( n = 30 ) received the same amount of these LC n-3 PUFAs as microencapsulated fish oil powder and regular meals ; and group 3 ( n = 31 ) was the control group , which received placebo powder and regular meals .
METHODS	Blood samples were taken from fingertips at baseline and at the end point .
RESULTS	Seventy-seven subjects ( 77.8 % ) completed the study .
RESULTS	The amount of EPA in blood doubled in both groups that received LC n-3 PUFAs ( P < 0.05 ) , but it did not change in the control group .
RESULTS	The changes in DHA were less but still significant in both intervention groups .
RESULTS	According to multivariate analysis , both intervention groups had higher end-point LC n-3 PUFA concentrations compared with placebo , but differences between intervention groups were not significant .
CONCLUSIONS	Bioavailability of LC n-3 PUFAs in encapsulated powder is very similar to the bioavailability of LC n-3 PUFAs in ready-to-eat meals enriched with liquid fish oil .
CONCLUSIONS	Thus , encapsulated powder can be considered useful to increase LC n-3 PUFA concentrations in blood .

###25658017
BACKGROUND	Short sleep duration is associated with an increased risk of type 2 diabetes .
BACKGROUND	Subchronic sleep restriction ( SR ) causes insulin resistance , but the mechanisms and roles of specific tissues are unclear .
OBJECTIVE	The purpose of this article was to determine whether subchronic SR altered ( 1 ) hepatic insulin sensitivity , ( 2 ) peripheral insulin sensitivity , and ( 3 ) substrate utilization .
METHODS	This was a randomized crossover study in which 14 subjects underwent 2 admissions separated by a washout period .
METHODS	Each admission had 2 acclimatization nights followed by 5 nights of either SR ( 4 hours time in bed ) or normal sleep ( 8 hours time in bed ) .
METHODS	MAIN OUTCOME MEASURE/METHODS : Insulin sensitivity ( measured by hyperinsulinemic-euglycemic clamp ) and hepatic insulin sensitivity ( measured by stable isotope techniques ) were measured .
METHODS	In addition , we assayed stress hormone ( 24-hour urine free cortisol , metanephrine , and normetanephrine ) , nonesterified fatty acid ( NEFA ) , and - hydroxybutyrate ( - OH butyrate ) levels .
METHODS	Resting energy expenditure ( REE ) and respiratory quotient ( RQ ) were measured by indirect calorimetry .
RESULTS	Compared to normal sleep , whole-body insulin sensitivity decreased by 25 % ( P = .008 ) with SR and peripheral insulin sensitivity decreased by 29 % ( P = .003 ) .
RESULTS	Whereas hepatic insulin sensitivity ( endogenous glucose production ) did not change significantly , percent gluconeogenesis increased ( P = .03 ) .
RESULTS	Stress hormones increased modestly ( cortisol by 21 % , P = .04 ; metanephrine by 8 % , P = .014 ; normetanephrine by 18 % , P = .002 ) .
RESULTS	Fasting NEFA and - OH butyrate levels increased substantially ( 62 % and 55 % , respectively ) .
RESULTS	REE did not change ( P = 0.98 ) , but RQ decreased ( 0.81 .02 vs 0.75 0.02 , P = .045 ) .
CONCLUSIONS	Subchronic SR causes unique metabolic disturbances characterized by peripheral , but not hepatic , insulin resistance ; this was associated with a robust increase in fasting NEFA levels ( indicative of increased lipolysis ) , decreased RQ , and increased - OH butyrate levels ( indicative of whole-body and hepatic fat oxidation , respectively ) .
CONCLUSIONS	We postulate that elevated NEFA levels are partially responsible for the decrease in peripheral sensitivity and modulation of hepatic metabolism ( ie , increase in gluconeogenesis without increase in endogenous glucose production ) .
CONCLUSIONS	Elevated cortisol and metanephrine levels may contribute to insulin resistance by increasing lipolysis and NEFA levels .

###24915052
OBJECTIVE	Measurement of central blood pressure provides prognostic information beyond conventional peripheral blood pressure ( BP ) .
OBJECTIVE	However , few studies have directly compared the effects of antihypertensives on central hemodynamics .
OBJECTIVE	This study investigated the effects of a low-dose combination of nifedipine Gastrointestinal Therapeutic System ( GITS ) and valsartan versus high-dose monotherapy with either agent in reducing central BP in essential hypertension inadequately controlled by low-dose monotherapy .
METHODS	In this prospective , open-label , randomized , active-controlled , multicenter 8-week study , patients not meeting the target BP after 4 weeks of treatment with low-dose monotherapy were randomized to receive nifedipine GITS 30mg plus valsartan 80mg ( N30 + V80 ) , nifedipine GITS 60mg ( N60 ) , or valsartan 160mg ( V160 ) for a further 4 weeks .
METHODS	Central hemodynamics were measured by applanation tonometry .
RESULTS	A total of 391 patients were enrolled .
RESULTS	Reduction in central systolic BP from baseline to week 8 , the primary efficacy variable , was significantly greater in the N30 + V80 group ( -27.214.7 mmHg ) and the N60 group ( -27.116.5 mmHg ) compared with V160 group ( -14.416.6 mmHg ) .
RESULTS	Decrease in the augmentation index in the N60 group was significantly greater compared with V160 alone , without differences between combination therapy and either high-dose monotherapy .
RESULTS	Decreases in brachial systolic BP were significantly greater in the N30 + V80 and N60 groups than in the V160 group .
RESULTS	By multiple regression analysis , most differences in drug effects on central hemodynamics disappeared after controlling for changes in peripheral BP .
RESULTS	A low rate of adverse events occurred in all treatment groups .
CONCLUSIONS	A low-dose combination of nifedipine GITS plus valsartan or high-dose nifedipine was more effective in improving central hemodynamics than high-dose valsartan in patients with hypertension , mostly because of the improvement in peripheral ( brachial ) hemodynamics .

###24684662
OBJECTIVE	To develop and examine the effectiveness of a home-based self-help psychoeducation programme on health-related quality of life , stress level , anxiety and depression symptoms , self-efficacy , cardiac risk factors and health service use of outpatients with coronary heart disease .
BACKGROUND	Hospital-based cardiac rehabilitation programmes have been shown to improve , effectively , the quality of life of patients with coronary heart disease .
BACKGROUND	However , a majority of these patients do not participate in these programmes , while those who do enrol in these programmes fail to complete the programmes .
METHODS	Randomized controlled trial with repeated measures .
METHODS	This study was approved and received the grant in July 2013 .
METHODS	A convenience sample of 128 coronary heart disease outpatients will be recruited from a tertiary hospital in Singapore .
METHODS	Participants are randomly assigned to the 4-week experimental group and will participate in the programme or the control group who will not participate in the programme .
METHODS	The outcome measures include the : 12-item Short Form Health Survey , Perceived Stress Scale , Hospital Anxiety and Depression Scale and General Self-Efficacy Scale .
METHODS	Data will be collected at baseline , then 4 and 16 weeks from baseline .
METHODS	At the end , a process evaluation will be conducted to assess the acceptability , strengths and weaknesses of our programme based on the participants ' perspectives .
CONCLUSIONS	Our programme offers coronary heart disease patients an additional option to the existing cardiac rehabilitative services in Singapore hospitals .
CONCLUSIONS	It aims to help them manage their disease effectively by reducing cardiac risk factors and improve their health-related quality of life and psychological well-being .

###25351118
OBJECTIVE	To investigate the guiding role of narrow-band imaging endoscopy in laryngeal malignant lesion biopsy .
METHODS	From February 2013 to January 2014 , 113 patients suspected of laryngeal malignant lesions after electronic nasopharyngolaryngoscope screening were included in the study .
METHODS	The patients were randomly divided into two groups , 58 cases in group A underwent laryngeal tumor biopsies in the white light mode and 55 cases in group B did in NBI mode .
METHODS	The patients were applied with corresponding surgery treatment according to the biopsy results .
METHODS	Postoperative pathologic examination result was as a gold standard for identifing the laryngeal diseases .
RESULTS	The positive rate of malignant lesions in group A ( 71.1 % , 32/45 ) was significantly lower than that in group B ( 95.4 % , 42/44 ) ( = 7.75 , P < 0.05 ) ; the accurate rate of biopsy in group A ( 77.6 % , 45/58 ) was significantly lower than that in group B ( 96.4 % , 53/55 , = 7.09 , P < 0.05 ) .
CONCLUSIONS	Narrow-band imaging endoscopy can obviously improve in the detection of laryngeal malignant lesion by biopsy .

###24476560
OBJECTIVE	Universal interventions may widen or narrow inequalities if disproportionately effective among higher or lower socio-economic groups .
OBJECTIVE	The present paper examines impacts of the Primary School Free Breakfast Initiative in Wales on inequalities in children 's dietary behaviours and cognitive functioning .
METHODS	Cluster-randomised controlled trial .
METHODS	Responses were linked to free school meal ( FSM ) entitlement via the Secure Anonymised Information Linkage databank .
METHODS	Impacts on inequalities were evaluated using weighted school-level regression models with interaction terms for intervention whole-school percentage FSM entitlement and intervention aggregated individual FSM entitlement .
METHODS	Individual-level regression models included interaction terms for intervention individual FSM entitlement .
METHODS	Fifty-five intervention and fifty-six wait-list control primary schools .
METHODS	Approximately 4500 children completed measures of dietary behaviours and cognitive tests at baseline and 12-month follow-up .
RESULTS	School-level models indicated that children in intervention schools ate a greater number of healthy items for breakfast than children in control schools ( b = 025 ; 95 % CI 007 , 044 ) , with larger increases observed in more deprived schools ( interaction term b = 176 ; 95 % CI 036 , 316 ) .
RESULTS	An interaction between intervention and household-level deprivation was not significant .
RESULTS	Despite no main effects on breakfast skipping , a significant interaction was observed , indicating declines in breakfast skipping in more deprived schools ( interaction term b = -007 ; 95 % CI -015 , -000 ) and households ( OR = 067 ; 95 % CI 046 , 098 ) .
RESULTS	No significant influence on inequality was observed for the remaining outcomes .
CONCLUSIONS	Universal breakfast provision may reduce socio-economic inequalities in consumption of healthy breakfast items and breakfast skipping .
CONCLUSIONS	There was no evidence of intervention-generated inequalities in any outcomes .

###24799539
OBJECTIVE	Evolving primary care models require methods to help practices achieve quality standards .
OBJECTIVE	This study assessed the effectiveness of a Practice-Tailored Facilitation Intervention for improving delivery of 3 pediatric preventive services .
METHODS	In this cluster-randomized trial , a practice facilitator implemented practice-tailored rapid-cycle feedback/change strategies for improving obesity screening/counseling , lead screening , and dental fluoride varnish application .
METHODS	Thirty practices were randomized to Early or Late Intervention , and outcomes assessed for 16419 well-child visits .
METHODS	A multidisciplinary team characterized facilitation processes by using comparative case study methods .
RESULTS	Baseline performance was as follows : for Obesity : 3.5 % successful performance in Early and 6.3 % in Late practices , P = .74 ; Lead : 62.2 % and 77.8 % success , respectively , P = .11 ; and Fluoride : < 0.1 % success for all practices .
RESULTS	Four months after randomization , performance rose in Early practices , to 82.8 % for Obesity , 86.3 % for Lead , and 89.1 % for Fluoride , all P < .001 for improvement compared with Late practices ' control time .
RESULTS	During the full 6-month intervention , care improved versus baseline in all practices , for Obesity for Early practices to 86.5 % , and for Late practices 88.9 % ; for Lead for Early practices to 87.5 % and Late practices 94.5 % ; and for Fluoride , for Early practices to 78.9 % and Late practices 81.9 % , all P < .001 compared with baseline .
RESULTS	Improvements were sustained 2 months after intervention .
RESULTS	Successful facilitation involved multidisciplinary support , rapid-cycle problem solving feedback , and ongoing relationship-building , allowing individualizing facilitation approach and intensity based on 3 levels of practice need .
CONCLUSIONS	Practice-tailored Facilitation Intervention can lead to substantial , simultaneous , and sustained improvements in 3 domains , and holds promise as a broad-based method to advance pediatric preventive care .

###25298250
BACKGROUND	The Stent-In 2 trial randomized patients with malignant colonic obstruction to emergency surgery or stent placement as a bridge to elective surgery .
BACKGROUND	The aim of this study was to compare the oncological outcomes .
METHODS	Disease recurrence , and disease-free , disease-specific and overall survival were evaluated , including a subgroup analysis of patients with a stent - or guidewire-related perforation .
RESULTS	Of 98 patients included in the original Stent-In 2 trial , patients with benign ( 16 ) or incurable ( 23 ) disease were excluded from this study , along with a patient who had withdrawn from the trial .
RESULTS	Of the remaining 58 patients , 32 were randomized to emergency surgery ( 31 resection , 1 stoma only ) and 26 to stenting .
RESULTS	Unsuccessful stenting required emergency surgery in six patients owing to wire or stent perforation .
RESULTS	Locoregional or distant disease recurrence developed in nine of 32 patients in the emergency surgery group and 13 of 26 in the stent group .
RESULTS	Disease-free survival was worse in the subgroup with stent - or guidewire-related perforation .
RESULTS	Five of six patients in this subgroup developed a recurrence , compared with nine of 32 in the emergency surgery group and eight of 20 who had unperforated stenting .
CONCLUSIONS	Stent placement for malignant colonic obstruction was associated with a risk of recurrence in this trial , but the numbers are small .
CONCLUSIONS	There is not enough evidence to refute the approach strongly .
BACKGROUND	ISRCTN46462267 ( http://www.controlled-trials.com ) .

###24626789
OBJECTIVE	Previous studies have found that family-focused treatment is an effective adjunct to pharmacotherapy in stabilizing symptoms in adult bipolar disorder .
OBJECTIVE	The authors examined whether pharmacotherapy and family-focused treatment for adolescents with bipolar disorder was more effective than pharmacotherapy and brief psychoeducation ( enhanced care ) in decreasing time to recovery from a mood episode , increasing time to recurrence , and reducing symptom severity over 2 years .
METHODS	A total of 145 adolescents ( mean age , 15.6 years ) with bipolar I or II disorder and a DSM-IV-TR manic , hypomanic , depressive , or mixed episode in the previous 3 months were randomly assigned , with family members , either to pharmacotherapy and family-focused treatment , consisting of psychoeducation ( i.e. , recognition and early intervention with prodromal symptoms ) , communication enhancement training , and problem-solving skills training , delivered in 21 sessions over 9 months ; or to pharmacotherapy and three weekly sessions of enhanced care ( family psychoeducation ) .
METHODS	Independent evaluators assessed participants at baseline , every 3 months during year 1 , and every 6 months during year 2 , using weekly ratings of mood .
RESULTS	Twenty-two participants ( 15.2 % ) withdrew shortly after randomization .
RESULTS	Time to recovery or recurrence and proportion of weeks ill did not differ between the two treatment groups .
RESULTS	Secondary analyses revealed that participants in family-focused treatment had less severe manic symptoms during year 2 than did those in enhanced care .
CONCLUSIONS	After an illness episode , intensive psychotherapy combined with best-practice pharmacotherapy does not appear to confer advantages over brief psychotherapy and pharmacotherapy in hastening recovery or delaying recurrence among adolescents with bipolar disorder .

###24996807
BACKGROUND	Malaria and HIV are two major causes of morbidity and mortality among pregnant women in sub-Saharan Africa .
BACKGROUND	Foetal and neonatal outcomes of this co-infection have been extensively studied .
BACKGROUND	However , little is known about maternal morbidity due to clinical malaria in pregnancy , especially malaria-related fever , in the era of generalized access to antiretroviral therapy and anti-malarial preventive strategies .
METHODS	A cohort study was conducted in order to estimate the incidence rate and to determine the factors associated with malaria-related fever , as well as the maternal morbidity attributable to malaria in a high-transmission setting of South Benin among HIV-infected pregnant women .
METHODS	Four-hundred and thirty-two women who participated in a randomized trial testing strategies to prevent malaria in pregnancy were included and followed until delivery , with at least three scheduled visits during pregnancy .
METHODS	Confirmed malaria-related fever was defined as axillary temperature > 37.5 C and a concomitant , positive , thick blood smear or rapid diagnostic test for Plasmodium falciparum .
METHODS	Suspected malaria-related fever was defined as an axillary temperature > 37.5 C and the concomitant administration of an anti-malarial treatment in the absence of parasitological investigation .
RESULTS	Incidence rate for confirmed malaria-related fever was of 127.9 per 1,000 person-year ( PY ) ( 95 % confidence interval ( CI ) : 77.4-211 .2 ) .
RESULTS	In multivariate analysis , CD4 lymphocytes ( Relative Risk ( RR ) for a 50 cells/mm3 variation = 0.82 ; CI : 0.71-0 .96 ) , antiretroviral treatment started before inclusion ( RR = 0.34 ; CI : 0.12-0 .98 ) and history of symptomatic malaria in early pregnancy ( RR = 7.10 ; CI : 2.35-22 .49 ) were associated with the incidence of confirmed or suspected malaria-related fever .
RESULTS	More than a half of participants with parasitaemia were symptomatic , with fever being the most common symptom .
RESULTS	The crude fraction of febrile episodes attributable to malaria was estimated at 91 % .
CONCLUSIONS	This work highlights that malaria is responsible for a substantial morbidity in HIV-infected pregnant women , with cellular immunodepression as a major determinant , and establishes the possible advantage offered by the early initiation of antiretroviral treatment .
BACKGROUND	PACOME Study has been registered under the number NCT00970879 .

###24979287
OBJECTIVE	The aims of this study were ( 1 ) to explore the effectiveness of dyad practice compared with individual practice on a simulator for learning a complex clinical skill and ( 2 ) to explore medical students ' perceptions of how and why dyad practice on a simulator contributes to learning a complex skill .
METHODS	In 2011 , the authors randomly assigned 84 medical students to either the dyad or the individual practice group to learn coronary angiography skills using instruction videos and a simulator .
METHODS	Two weeks later , participants each performed two video-recorded coronary angiographies on the simulator .
METHODS	Two raters used a rating scale to assess the participants ' video-recorded performance .
METHODS	The authors then interviewed the participants in the dyad practice group .
RESULTS	Seventy-two ( 86 % ) participants completed the study .
RESULTS	The authors found no significant difference between the performance scores of the two groups ( meanstandard deviation , 68 % 13 % for individual versus 63 % 16 % for dyad practice ; P = .18 ) .
RESULTS	Dyad practice participants noted that several key factors contributed to their learning : being equal-level novices , the quality of the cooperation between partners , observational learning and overt communication , social aspects and motivation , and meta-cognition .
CONCLUSIONS	Dyad practice is more efficient and thus more cost-effective than individual practice and can be used for costly virtual reality simulator training .
CONCLUSIONS	However , dyad practice may not apply to clinical training involving real patients because learning from errors and overt communication , both keys to dyad practice , do not transfer to clinical practice .

###25948782
BACKGROUND	Iron deficiency is the most widespread nutritional deficiency in the world .
OBJECTIVE	The objective of this randomized efficacy trial was to determine the effects of iron-biofortified pearl millet ( Fe-PM ) on iron status compared with control pearl millet ( Control-PM ) .
METHODS	A randomized trial of biofortified pearl millet ( Pennisetum glaucum ) , bred to enhance iron content , was conducted in 246 children ( 12-16 y ) for 6 mo in Maharashtra , India .
METHODS	Iron status [ hemoglobin , serum ferritin ( SF ) , soluble transferrin receptor ( sTfR ) , and total body iron ( TBI ) ] , inflammation ( C-reactive protein and -1 acid glycoprotein ) , and anthropometric indices were evaluated at enrollment and after 4 and 6 mo. .
METHODS	Hodges-Lehmann-Sen 95 % CIs were used to examine the effect of the Fe-PM on iron status compared with commercially available Control-PM .
METHODS	Linear and binomial regression models were used to evaluate the effects of Fe-PM on iron status and incidence of anemia and iron deficiency , compared with Control-PM .
RESULTS	At baseline , 41 % of children were iron deficient ( SF < 15 g/L ) and 28 % were anemic ( hemoglobin < 12.0 g/dL ) .
RESULTS	Fe-PM significantly increased SF concentrations and TBI after 4 mo compared with Control-PM .
RESULTS	Among children who were iron deficient at baseline , those who received Fe-PM were 1.64 times more likely to become iron replete by 6 mo than were those receiving Control-PM ( RR : 1.64 , 95 % CI : 1.07 , 2.49 , P = 0.02 ) .
RESULTS	The effects of Fe-PM on iron status were greater among children who were iron deficient at baseline than among children who were not iron deficient at baseline .
CONCLUSIONS	Fe-PM significantly improved iron status in children by 4 mo compared with Control-PM .
CONCLUSIONS	This study demonstrated that feeding Fe-PM is an efficacious approach to improve iron status in school-age children and it should be further evaluated for effectiveness in a broader population context .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT02152150 .

###25176414
OBJECTIVE	To investigate whether basic laparoscopic skills acquired via structured spaced training on a box trainer persist after 6 months .
METHODS	In a prospective study undertaken at the Ege University School of Medicine ( Izmir , Turkey ) between January 1 , 2012 , and June 1 , 2013 , 22 gynecology residents without previous laparoscopy experience were randomly assigned ( 1:1 ) to receive training with a box trainer ( 1 hour per week for 4 weeks ) or to a control group .
METHODS	At baseline and at 5 weeks , residents ' performance was assessed via the salpingectomy module of LapSim .
METHODS	The box trainer group was reassessed for skills retention 6 months later .
RESULTS	The box trainer group performed significantly better than the control group in time ( P = 0.01 ) and economy of movement ( P = 0.001 ) at the final test .
RESULTS	Error scores did not differ significantly .
RESULTS	Deterioration between final and retention tests in the box trainer group were recorded in time ( P = 0.041 ) , instrument path length ( P = 0.013 ) , and instrument angular path ( P = 0.075 ) .
RESULTS	However , time and economy of movement scores were better at the retention assessment than at baseline ( P = 0.008 and P = 0.003 , respectively ) .
CONCLUSIONS	Structured training with a box trainer improved laparoscopic skills , but deterioration was evident within 6 months .
CONCLUSIONS	This deterioration should be considered when planning laparoscopic training programs .

###24844787
OBJECTIVE	Anthracycline-induced cardiotoxicity is ( partly ) mediated by free radical overload .
OBJECTIVE	A randomized study was performed in breast cancer patients to investigate whether free radical scavenger super oxide dismutase ( SOD ) protects against anthracycline-induced cardiotoxicity as measured by changes in echo , electrocardiography and an array of biomarkers .
RESULTS	Eighty female , chemotherapy-nave breast cancer patients ( median age 49 , range 24-67 years ) scheduled for four or five courses of adjuvant 3 weekly doxorubicin plus cyclophosphamide ( AC ) chemotherapy , were randomly assigned to receive 80mg PC-SOD ( human recombinant SOD bound to lecithin ) or placebo , administered intravenously ( i.v. ) immediately prior to each AC course .
RESULTS	The primary end point was protection against cardiac damage evaluated using echocardiography , QT assessments and a set of biochemical markers for myocardial function , oxidative stress and inflammation .
RESULTS	Assessments were performed before and during each course of chemotherapy , and at 1 , 4 and 9 months after completion of the chemotherapy regimen .
RESULTS	In all patients cardiac effects such as increases in NT-proBNP concentration and prolongation of the QTc interval were noticed .
RESULTS	There were no differences between the PC-SOD and placebo-treated patients in systolic or diastolic cardiac function or for any other of the biomarkers used to assess the cardiac effects of anthracyclines .
CONCLUSIONS	PC-SOD at a dose of 80mg i.v. is not cardioprotective in patients with breast carcinoma treated with anthracyclines .

###25436213
BACKGROUND	Diuresis is a major therapy for the reduction of congestive symptoms in acute decompensated heart failure ( ADHF ) patients .
BACKGROUND	We previously reported the efficacy and safety of tolvaptan compared to carperitide in hospitalized patients with ADHF .
BACKGROUND	There were some reports of cardio - and renal-protective effects in carperitide ; therefore , the purpose of this study was to compare the long-term effects of tolvaptan and carperitide on cardiorenal function and prognosis .
RESULTS	One hundred and five ADHF patients treated with either tolvaptan or carperitide were followed after hospital discharge .
RESULTS	Levels of plasma B-type natriuretic peptide , serum sodium , potassium , creatinine , and estimated glomerular filtration rate were measured before administration of tolvaptan or carperitide at baseline , the time of discharge , and one year after discharge .
RESULTS	These data between tolvaptan and carperitide groups were not different one year after discharge .
RESULTS	Kaplan-Meier survival curves demonstrated that the event-free rate regarding all events , cardiac events , all cause deaths , and rehospitalization due to worsening heart failure was not significantly different between tolvaptan and carperitide groups .
CONCLUSIONS	We demonstrated that tolvaptan had similar effects on cardiac and renal function and led to a similar prognosis in the long term , compared to carperitide .

###25919553
OBJECTIVE	To explore the clinical efficacy of high-frequency oscillatory ventilation ( HFOV ) combined with pulmonary surfactant ( PS ) in the treatment of neonatal pulmonary hemorrhage ( NPH ) .
METHODS	A total of 122 neonates diagnosed with NPH between January 2010 and June 2014 were enrolled .
METHODS	After being stratified by gestational age , the neonates were randomly divided into treatment ( HFOV+PS ) and control ( HFOV alone ) groups ( n = 61 each ) .
METHODS	Both groups were treated with HFOV after the onset of NPH .
METHODS	After 2-4 hours of HFOV treatment , the treatment group received PS via intratracheal injections , followed by continuous use of HFOV .
METHODS	Dynamic changes in the blood gas , oxygenation index ( OI ) , and PaO2/FiO2 ( P/F ) values of the neonates were determined before HFOV treatment and after 6 , 12 , and 24 hours of HFOV treatment .
METHODS	The time to hemostasis , duration of ventilation , incidence of complications , and cure rate were compared between groups .
RESULTS	After 6 , 12 , and 24 hours of HFOV treatment , the treatment group had significantly improved PaO2 , PaCO2 , O/I , and P/F values compared with the control group ( P < 0.05 ) .
RESULTS	The time to hemostasis and the duration of ventilation were significantly shorter in the treatment group than in the control group ( P < 0.01 ) , and the incidence of complications was lower in the former than in the latter ( P < 0.05 ) .
RESULTS	There was no significant difference in the cure rate between the treatment ( 87 % ) and control ( 82 % ) groups ( P > 0.05 ) .
CONCLUSIONS	HFOV combined with PS is an effective treatment to improve oxygenation , shorten the time to hemostasis and the duration of ventilation , and reduce the incidence of complications in neonates with NPH .
CONCLUSIONS	However , the dual therapy is unable to reduce the mortality of neonates compared with HFOV monotherapy .

###25001621
BACKGROUND	Our objective was to evaluate the effect of intensive care treatment on the protein binding of sufentanil and hydromorphone in cardiac surgery patients during postoperative analgesia using a target-controlled infusion ( TCI ) and patient-controlled analgesia ( PCA ) .
METHODS	Fifty adult patients were enrolled in this prospective randomized study ; of which , 49 completed the study ( age range 40-81 yr ) .
METHODS	Sufentanil was administered as an analgesic intraoperatively , and hydromorphone was dosed after operation with TCI and PCA until 8 a.m. on the first postoperative day .
METHODS	Arterial plasma samples were collected for drug and protein concentration measurements up to 24 h after cardiac surgery .
METHODS	Corresponding patient data were collected from the electronic patient data system .
METHODS	After explorative data analysis with principal component analysis , multivariate regression analysis and non-linear mixed effects modelling was used to study the effect of treatment on protein binding .
RESULTS	Data of 35 patients were analysed .
RESULTS	The median protein binding of sufentanil and hydromorphone was 88.4 % ( IQ range 85.7-90 .5 % ) and 11.6 % ( IQ range 9.5-14 .3 % ) , respectively .
RESULTS	Free fraction of sufentanil increased towards the end of the study period , whereas hydromorphone free fraction remained nearly constant .
RESULTS	The total sufentanil concentration and volume balance were identified as significant covariates for the protein binding of sufentanil .
RESULTS	For the protein binding of hydromorphone , no significant covariate effects were found .
CONCLUSIONS	Sufentanil protein binding was significantly dependent on changes in the total drug concentration and volume balance addressing the importance of adequate dosing and fluid-guided therapy .
CONCLUSIONS	Hydromorphone protein binding was nearly constant throughout the study period .
BACKGROUND	EudraCT 2011-003648-31 and ClinicalTrials.gov : NCT01490268 .

###24567281
OBJECTIVE	To determine whether self-expanding plastic stent ( SEPS ) placement significantly improves quality of life and maintains optimal nutrition while allowing full-dose neoadjuvant therapy ( NAT ) in patients with esophageal cancer .
METHODS	A prospective , dual-institution , single-arm , phase II ( http://ClinicalTrials.gov: NCT00727376 ) evaluation of esophageal cancer patients undergoing NAT prior to resection .
METHODS	All patients had a self-expanding polymer stent placed prior to NAT .
METHODS	The European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-OG25 , Functional Assessment of Cancer Therapy-Anorexia , and Functional Assessment of Cancer Therapy-General surveys were administered prior to stenting , within 1 week post-stent placement , and at the completion of neoadjuvant therapy .
RESULTS	Fifty-two patients were enrolled ; 3 ( 5.8 % ) had stent migrations requiring replacement .
RESULTS	There were no instances of esophageal erosion or perforation .
RESULTS	All patients received some form of neoadjuvant therapy .
RESULTS	Thirty-six ( 69 % ) received chemoradiation ; 34 ( 93 % ) of these patients received the planned dose of chemotherapy , and 27 ( 75 % ) received the full planned dose of radiotherapy .
RESULTS	There were 16 ( 31 % ) patients receiving chemotherapy alone ; 12 ( 74 % ) of patients in the chemotherapy-alone group completed the planned dose of therapy .
CONCLUSIONS	Placement of SEPS appears to provide significant improvement in quality of life related to dysphagia and eating restriction in patients with esophageal cancer undergoing neoadjuvant therapy .
CONCLUSIONS	Consideration of SEPS instead of percutaneous feeding tube should be initiated as a first line in dysphagia palliation and NAT nutritional support .

###25135060
BACKGROUND	Creatine supplementation has emerged as a promising non-pharmacological therapeutic strategy to counteract muscle dysfunction and low lean mass in a variety of conditions , including in pediatric and rheumatic diseases .
BACKGROUND	The objective of this study was to examine the efficacy and safety of creatine supplementation in childhood systemic lupus erythematosus ( C-SLE ) .
METHODS	C-SLE patients with mild disease activity ( n = 15 ) received placebo or creatine supplementation in a randomized fashion using a crossover , double-blind , repeated-measures design .
METHODS	The participants were assessed at baseline and after 12 weeks in each arm , interspersed by an eight-week washout period .
METHODS	The primary outcomes were muscle function , as assessed by a battery of tests including one-maximum repetition ( 1-RM ) tests , the timed-up-and-go test , the timed-stands test , and the handgrip test .
METHODS	Secondary outcomes included body composition , biochemical markers of bone remodeling , aerobic conditioning , quality of life , and physical capacity .
METHODS	Possible differences in dietary intake were assessed by three 24-hour dietary recalls .
METHODS	Muscle phosphorylcreatine content was measured through phosphorus magnetic resonance spectroscopy ( 31 P-MRS ) .
METHODS	The safety of the intervention was assessed by laboratory parameters , and kidney function was measured by ( 51 ) Cr-EDTA clearance .
METHODS	Additionally , self-reported adverse events were recorded throughout the trial .
RESULTS	Intramuscular phosphorylcreatine content was not significantly different between creatine and placebo before or after the intervention ( creatine-Pre : 20.5 2.6 , Post : 20.4 4.1 , placebo-Pre : 19.8 2.0 ; Post : 20.2 3.2 mmol/kg wet muscle ; p = 0.70 for interaction between conditions ) .
RESULTS	In addition , probably as a consequence of the lack of change in intramuscular phosphorylcreatine content , there were no significant changes between placebo and creatine for any muscle function and aerobic conditioning parameters , lean mass , fat mass , bone mass , and quality of life scores ( p > 0.05 ) .
RESULTS	The ( 51 ) Cr-EDTA clearance was not altered by creatine supplementation and no side effects were noticed .
CONCLUSIONS	A 12-week creatine supplementation protocol at 0.1 g/kg/d is well tolerated and free of adverse effects but did not affect intramuscular phosphorylcreatine , muscle function , free-fat mass or quality of life in non-active C-SLE patients .
BACKGROUND	Clinicaltrials.gov number : NCT01217320 .

###24337978
OBJECTIVE	Inhibition of brain aminopeptidase A ( APA ) , which converts angiotensin II into angiotensin III , has emerged as a novel antihypertensive treatment , as demonstrated in several experimental animal models .
OBJECTIVE	QGC001 ( originally named RB150 ) is a prodrug of the specific and selective APA inhibitor EC33 , and as such it is the prototype of a new class of centrally acting antihypertensive agents .
OBJECTIVE	Given by the oral route in hypertensive rats , it enters the brain and generates EC33 , which blocks the brain renin-angiotensin system activity and normalises blood pressure .
OBJECTIVE	The aim of the present study was to evaluate the safety , pharmacokinetics and pharmacodynamic effects of QGC001 in humans .
METHODS	Fifty-six healthy male volunteers were randomly assigned to receive in double-blind and fasted conditions single oral doses of 10 , 50 , 125 , 250 , 500 , 750 , 1,000 and 1,250 mg of QGC001 ( n = 6/dose ) or placebo ( n = 2/dose ) .
METHODS	We measured plasma and urine concentrations of both QGC001 and EC33 by liquid chromatography-tandem mass spectrometry , plasma renin concentrations ( PRC ) , plasma and free urine aldosterone ( PAldo and UAldo ) , plasma copeptine ( PCop ) , and plasma and urine cortisol ( PCort and UCort ) concentrations , and supine systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) and heart rate ( HR ) at various time points .
RESULTS	All doses of QGC001 were clinically and biologically well-tolerated .
RESULTS	Peak plasma concentrations ( Cmax ) of QGC001 and EC33 increased linearly with the dose , with a median time to reach Cmax ( tmax ) of 1.5 h for QGC001 and 3.0 h for EC33 .
RESULTS	The median plasma elimination half-life of QGC001 was 1.6 h consistently throughout doses .
RESULTS	Urinary excretion of QGC001 and EC33 was below 2 % of the administered dose .
RESULTS	When compared with placebo , QGC001 did not significantly change PRC , PAldo , UAldo , PCop , PCort or UCort .
RESULTS	No significant change was observed for supine HR , SBP and DBP in any treatment group .
CONCLUSIONS	Single oral administration of QGC001 up to 1,250 mg in healthy volunteers was well-tolerated .
CONCLUSIONS	Following oral administration , QGC001 is absorbed via the gastrointestinal tract and converted partially into its active metabolite EC33 in plasma .
CONCLUSIONS	As in animal experiments , in normotensive subjects QGC001 had no effect on the systemic renin-angiotensin-aldosterone parameters and on PCop concentrations , a marker of vasopressin release .
CONCLUSIONS	In normotensive subjects , a single dose of QCG001 had no effect on SBP , DBP or HR .
CONCLUSIONS	These data support further evaluation of multiple oral doses of QGC001 in human volunteers and its clinical efficacy in hypertensive patients .

###26135703
BACKGROUND	Interleukin 17A is a proinflammatory cytokine that is implicated in the pathogenesis of psoriatic arthritis .
BACKGROUND	We assessed the efficacy and safety of subcutaneous secukinumab , a human anti-interleukin-17A monoclonal antibody , in patients with psoriatic arthritis .
METHODS	In this phase 3 , double-blind , placebo-controlled study undertaken at 76 centres in Asia , Australia , Canada , Europe , and the USA , adults ( aged 18 years old ) with active psoriatic arthritis were randomly allocated in a 1:1:1:1 ratio with computer-generated blocks to receive subcutaneous placebo or secukinumab 300 mg , 150 mg , or 75 mg once a week from baseline and then every 4 weeks from week 4 .
METHODS	Patients and investigators were masked to treatment assignment .
METHODS	The primary endpoint was the proportion of patients achieving at least 20 % improvement in the American College of Rheumatology response criteria ( ACR20 ) at week 24 .
METHODS	Analysis was by intention to treat .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01752634 .
RESULTS	Between April 14 , and Nov 25 , 2013 , 397 patients were randomly assigned to receive secukinumab 300 mg ( n = 100 ) , 150 mg ( n = 100 ) , 75 mg ( n = 99 ) , or placebo ( n = 98 ) .
RESULTS	A significantly higher proportion of patients achieved an ACR20 at week 24 with secukinumab 300 mg ( 54 [ 54 % ] patients ; odds ratio versus placebo 681 , 95 % CI 342-1356 ; p < 00001 ) , 150 mg ( 51 [ 51 % ] patients ; 652 , 325-1308 ; p < 00001 ) , and 75 mg ( 29 [ 29 % ] patients ; 232 , 114-473 ; p = 00399 ) versus placebo ( 15 [ 15 % ] patients ) .
RESULTS	Up to week 16 , the most common adverse events were upper respiratory tract infections ( four [ 4 % ] , eight [ 8 % ] , ten [ 10 % ] , and seven [ 7 % ] with secukinumab 300 mg , 150 mg , 75 mg , and placebo , respectively ) and nasopharyngitis ( six [ 6 % ] , four [ 4 % ] , six [ 6 % ] , and eight [ 8 % ] , respectively ) .
RESULTS	Serious adverse events were reported by five ( 5 % ) , one ( 1 % ) , and four ( 4 % ) patients in the secukinumab 300 mg , 150 mg , and 75 mg groups , respectively , compared with two ( 2 % ) in the placebo group .
RESULTS	No deaths were reported .
CONCLUSIONS	Subcutaneous secukinumab 300 mg and 150 mg improved the signs and symptoms of psoriatic arthritis , suggesting that secukinumab is a potential future treatment option for patients with this disorder .
BACKGROUND	Novartis .

###24667391
BACKGROUND	Remifentanil , an ultra-short-acting opioid , is widely used for pain control during surgery .
BACKGROUND	However , regular dose ( RD ) remifentanil exacerbates postoperative pain in a dose-dependent manner .
BACKGROUND	Recent studies suggest that high-dose ( HD ) remifentanil offers sustained analgesia in experimental studies .
BACKGROUND	We thus hypothesized that intraoperative administration of high-dose remifentanil may attenuate postoperative pain .
METHODS	In this prospective , randomized , double blind , controlled clinical study , sixty patients undergoing thyroidectomy ( 18-60 years-of-age ) received an intraoperative infusion of 0.2 ( RD group ) or 1.2 g kg ( -1 ) min ( -1 ) ( HD group ) remifentanil during thyroidectomy .
METHODS	A visual analogue scale ( VAS ) was used to measure pain intensity .
METHODS	Mechanical pain threshold on the forearm was assessed using von Frey filaments before surgery ( baseline ) , 2 h postoperatively and 18-24 h postoperatively .
METHODS	The primary outcome was to compare the difference of VAS score at different time points after operation and morphine consumption 24 h postoperatively between RD and HD groups .
METHODS	The second outcome was to compare the difference of mechanical pain thresholds in the forearm postoperatively between RD and the HD groups .
RESULTS	VAS scores were lower 30 min postoperatively in the HD group ( 1.29 1.67 , 95 % CI 0.64-1 .94 ) compared with the RD group ( 2.21 1.67 , 95 % CI 1.57-2 .84 ) ( t = 3.427 , p = 0.0043 , RD group vs. HD group ) .
RESULTS	Postoperative morphine consumption was much lower in the HD group compared with the RD group ( 1.27 1.88 mg vs. 0.35 1.25 mg , p = 0.033 ) .
RESULTS	In both groups , mechanical pain threshold was decreased 18-24 h postoperatively ( 2.93 0.209 Ln ( g ) vs. 3.454 2.072 Ln ( g ) , p = 0.032 in RD group ; 2.910 0.196 Ln ( g ) vs. 3.621 0.198 Ln ( g ) , p = 0.006 in HD group , 18-24 h postoperatively vs baseline ) .
CONCLUSIONS	Intraoperative administration of high-dose remifentanil decreased VAS scores and morphine consumption postoperatively .
CONCLUSIONS	Thus , modulation of intraoperative opiates may be a simple and effective method of postoperative pain management .
BACKGROUND	This trial is registered in ClinicalTrials.gov , with the Name : Effect of Higher Doses of Remifentanil on Postoperative Pain in Patients Undergoing Thyroidectomy , and ID number : NCT01761149 .

###24556755
OBJECTIVE	The aim of the present study was to determine whether an increased supply of energy , protein , essential fatty acids , and vitamin A reduces postnatal growth failure in very-low-birth-weight infants .
METHODS	Fifty infants with birth weight < 1500 g were randomized to an intervention ( n = 24 ) or a control ( n = 26 ) feeding protocol within 24 hours after birth .
METHODS	Forty-four infants were included in the final analysis .
METHODS	This study was discontinued because of an increased occurrence of septicemia in the intervention group .
RESULTS	The intervention group had a lower mean birth weight ( P = 0.03 ) and a higher proportion of infants small-for-gestational age ( P = 0.04 ) than the control group .
RESULTS	Other baseline characteristics were similar .
RESULTS	The median ( interquartile range ) energy and protein supplies during the first 4 weeks of life were higher in the intervention group : 139 ( 128-145 ) versus 126 ( 121-128 ) kcal kg day ( P < 0.001 ) and 4.0 ( 3.9-4 .2 ) versus 3.2 ( 3.1-3 .3 ) g kg day ( P < 0.001 ) .
RESULTS	The infants in the intervention group regained birth weight faster ( P = 0.001 ) and maintained their z scores for weight and head circumference from birth to 36 weeks ' postmenstrual age ( both P < 0.001 ) .
RESULTS	The median ( interquartile range ) growth velocity was 17.4 ( 16.3-18 .6 ) g kg day in the intervention group and 13.8 ( 13.2-15 .5 ) g kg day in the control group ( P < 0.001 ) .
RESULTS	In line with the improved growth in the intervention group , the proportion of growth-restricted infants was 11 of 23 both at birth and at 36 weeks ' postmenstrual age , whereas this proportion increased among the controls from 4 of 21 to 13 of 21 ( P = 0.04 ) .
CONCLUSIONS	Enhanced supply of energy , protein , essential fatty acids , and vitamin A caused postnatal growth along the birth percentiles for both weight and head circumference .

###24673834
BACKGROUND	The link between physical activity ( PA ) and prevention of disease , maintenance of independence , and improved quality of life in older adults is supported by strong evidence .
BACKGROUND	However , there is a lack of data on population levels in this regard , where PA level has been measured objectively .
BACKGROUND	The main aims were therefore to assess the level of accelerometer-determined PA and to examine its associations with self-reported health in a population of Norwegian older adults ( 65-85 years ) .
METHODS	This was a part of a national multicenter study .
METHODS	Participants for the initial study were randomly selected from the national population registry , and the current study included those of the initial sample aged 65-85 years .
METHODS	The ActiGraph GT1M accelerometer was used to measure PA for seven consecutive days .
METHODS	A questionnaire was used to register self-reported health .
METHODS	Univariate analysis of variance with Bonferroni adjustments were used for comparisons between multiple groups .
RESULTS	A total of 560 participants had valid activity registrations .
RESULTS	Mean age ( SD ) was 71.8 ( 5.6 ) years for women ( n = 282 ) and 71.7 ( 5.2 ) years for men ( n = 278 ) .
RESULTS	Overall PA level ( cpm ) differed considerably between the age groups where the oldest ( 80-85 y ) displayed a 50 % lower activity level compared to the youngest ( 65-70 y ) .
RESULTS	No sex differences were observed in overall PA within each age group .
RESULTS	Significantly more men spent time being sedentary ( 65-69 and 70-74 years ) and achieved more minutes of moderate to vigorous PA ( MVPA ) ( 75-79 years ) compared to women .
RESULTS	Significantly more women ( except for the oldest ) , spent more minutes of low-intensity PA compared to men .
RESULTS	PA differed across levels of self-reported health and a 51 % higher overall PA level was registered in those , with `` very good health '' compared to those with `` poor/very poor health '' .
CONCLUSIONS	Norwegian older adults PA levels differed by age .
CONCLUSIONS	Overall , the elderly spent 66 % of their time being sedentary and only 3 % in MVPA .
CONCLUSIONS	Twenty one percent of the participants fulfilled the current Norwegian PA recommendations .
CONCLUSIONS	Overall PA levels were associated with self-reported health .

###24529258
BACKGROUND	Obesity is one of the main determinants of avoidable disease burden.To implement a program by university students acting as `` health promoting agents '' ( HPAs ) and to evaluate the effects on obesity prevalence of the primary-school-based program that promotes healthy lifestyle , including dietary and physical activity recommendations over 28 months .
METHODS	Two school clusters were randomly assigned to intervention ( 24 schools , 1,222 pupils ) or control ( 14 schools , 717 pupils ) ; 78 % of pupils were Western European .
METHODS	Mean age ( SD ) was 8.40.6 years ( 49.9 % females ) at baseline .
METHODS	Generalized linear mixed models were used to analyze differences in primary outcome between both groups .
METHODS	Data collected included body mass index ( BMI ) every year .
METHODS	Dietary habits and lifestyle questionnaires were filled in by the parents at baseline and at the end of the study .
METHODS	The interventions focused on eight lifestyle topics covered in 12 activities ( 1 hour/activity/session ) implemented by HPAs over 3 school academic years .
RESULTS	At 28 months , obesity prevalence in boys was decreased -2.36 % in the intervention group ( from 9.59 % to 7.23 % ) and increased 2.03 % ( from 7.40 % to 9.43 % ) in the control group ; the difference was 4.39 % ( 95 % CI 3.48 to 5.30 ; P = 0.01 ) .
RESULTS	The boys in the intervention group had an effective reduction of -0.24 units in the change of BMI z-score ( from 0.01 to -0.04 ) , compared to control ( from -0.10 to 0.09 ) ; 5.1 % more intervention pupils undertook physical activity > 5 hours/week than control pupils ( P = 0.02 ) .
RESULTS	Fish consumption was a protector ( odds ratio 0.39 ; 95 % CI 0.23 to 0.67 ) while `` fast-food '' consumption was a risk factor for childhood obesity ( odds ratio : 2.27 ; 95 % CI 1.08 to 4.77 ) .
CONCLUSIONS	Our school-based program , conducted by HPA students , successfully reduced childhood obesity prevalence in boys .
BACKGROUND	International Standard Randomized Controlled Trial Number : ISRCTN29247645 .

###24649963
BACKGROUND	Effective physician communication at the end-of-life is a cornerstone to providing patient-centered palliative care .
BACKGROUND	Educational programs in physician communication often rely on self-assessments of physician knowledge and attitudes and seldom provide patients ' reports .
BACKGROUND	Thus , it is unclear whether physician self-assessments are associated with patient perspectives .
OBJECTIVE	To determine whether physician trainees ' self-assessments of their communication skills in religious/spiritual discussions were associated with assessments obtained from patients under their care .
METHODS	Prospective , observational , survey-based study of internal medicine trainees ' self-assessments matched with their patients ' reports .
METHODS	Data were obtained from preintervention surveys prior to the trainees participating in a communication educational intervention .
METHODS	The study took place at two internal medicine training programs , one in the southeastern United States and one in the northwestern United States .
METHODS	Our subjects were 181 physician trainees in internal medicine and 541 patients with advanced medical illnesses under their care .
METHODS	The outcomes were patient reports of the occurrence of religious/spiritual communication and patient ratings of the quality of this communication .
METHODS	The primary predictor of interest was trainees ' preintervention self-assessments of their competency in religious/spiritual communication .
RESULTS	Using multiple variable and path analysis we found that trainees ' self-assessments of their communication skills in religious/spiritual communication was significantly and positively associated with their patients ' reports of the occurrence and ratings of religious/spiritual communication .
CONCLUSIONS	Physician trainee self-assessments may be a valid surrogate for patient ratings of quality with respect to religious/spiritual communication .
CONCLUSIONS	This specific domain of physician-patient communication should receive further investigation as our finding contrasts with reports of more general measures of physician-patient end-of-life communication .

###25030782
BACKGROUND	Adolescents consume more sugar-sweetened beverages than do individuals in any other age group , but it is unknown how the type of sugar-sweetened beverage affects metabolic health in this population .
OBJECTIVE	The objective was to compare the metabolic health effects of short-term ( 2-wk ) consumption of high-fructose ( HF ) and high-glucose ( HG ) - sweetened beverages in adolescents ( 15-20 y of age ) .
METHODS	In a counterbalanced , single-blind fashion , 40 male and female adolescents completed two 2-wk trials that included 1 ) an HF trial in which they consumed 710 mL of a sugar-sweetened beverage/d ( equivalent to 50 g fructose/d and 15 g glucose/d ) for 2 wk and 2 ) an HG trial in which they consumed 710 mL of a sugar-sweetened beverage/d ( equivalent to 50 g glucose/d and 15 g fructose/d ) for 2 wk in addition to their normal ad libitum diet .
METHODS	In addition , the participants maintained similar physical activity levels during each trial .
METHODS	The day after each trial , insulin sensitivity and resistance [ assessed via Quantitative Insulin Sensitivity Check Index ( QUICKI ) and homeostatic model assessment of insulin resistance ( HOMA-IR ) index ] and fasting and postprandial glucose , lactate , lipid , cholesterol , insulin , C-peptide , insulin secretion , and clearance responses to HF or HG mixed meals were assessed .
RESULTS	Body weight , QUICKI ( whole-body insulin sensitivity ) , HOMA-IR ( hepatic insulin resistance ) , and fasting lipids , cholesterol , glucose , lactate , and insulin secretion or clearance were not different between trials .
RESULTS	Fasting HDL - and HDL-cholesterol concentrations were 10-31 % greater ( P < 0.05 ) in female adolescents than in male adolescents .
RESULTS	Postprandial triacylglycerol , HDL-cholesterol , HDL-cholesterol , and glucose concentrations were not different between HF and HG trials .
RESULTS	The lactate incremental area under the curve was 3.7-fold greater during the HF trial ( P < 0.05 ) , whereas insulin secretion was 19 % greater during the HG trial ( P < 0.05 ) .
CONCLUSIONS	Moderate amounts of HF - or HG-sweetened beverages for 2 wk did not have differential effects on fasting or postprandial cholesterol , triacylglycerol , glucose , or hepatic insulin clearance in weight-stable , physically active adolescents .

###24707475
OBJECTIVE	This study investigates consequences of chronic neck pain on muscle function and the rehabilitating effects of contrasting interventions .
METHODS	Women with trapezius myalgia ( MYA , n = 42 ) and healthy controls ( CON , n = 20 ) participated in a case-control study .
METHODS	Subsequently MYA were randomized to 10 weeks of specific strength training ( SST , n = 18 ) , general fitness training ( GFT , n = 16 ) , or a reference group without physical training ( REF , n = 8 ) .
METHODS	Participants performed tests of 100 consecutive cycles of 2s isometric maximal voluntary contractions ( MVC ) of shoulder elevation followed by 2s relaxation at baseline and 10-week follow-up .
RESULTS	In the case-control study , peak force , rate of force development , and rate of force relaxation as well as EMG amplitude were lower in MYA than CON throughout all 100 MVC .
RESULTS	Muscle fiber capillarization was not significantly different between MYA and CON .
RESULTS	In the intervention study , SST improved all force parameters significantly more than the two other groups , to levels comparable to that of CON .
RESULTS	This was seen along with muscle fiber hypertrophy and increased capillarization .
CONCLUSIONS	Women with trapezius myalgia have lower strength capacity during repetitive MVC of the trapezius muscle than healthy controls .
CONCLUSIONS	High-intensity strength training effectively improves strength capacity during repetitive MVC of the painful trapezius muscle .

###24344708
BACKGROUND	Childbirth is a demanding event in a woman 's life .
BACKGROUND	The aim of this study was to explore whether a brief intervention in the form of an antenatal course in self-hypnosis to ease childbirth could improve the childbirth experience .
METHODS	In a randomized , controlled , single-blinded trial , 1,222 healthy nulliparous women were allocated to one of three groups during pregnancy : A hypnosis group participating in three 1-hour sessions teaching self-hypnosis to ease childbirth , a relaxation group receiving three 1-hour lessons in various relaxation methods and Mindfulness , and a usual care group receiving ordinary antenatal care only .
METHODS	Wijmas Delivery Expectancy/Experience Questionnaire ( W-DEQ ) was used to measure the childbirth experience 6weeks postpartum .
RESULTS	The intention-to-treat analysis indicated that women in the hypnosis group experienced their childbirth as better compared with the other two groups ( mean W-DEQ score of 42.9 in the Hypnosis group , 47.2 in the Relaxation group , and 47.5 in the Care as usual group ( p = 0.01 ) ) .
RESULTS	The tendency toward a better childbirth experience in the hypnosis group was also seen in subgroup analyses for mode of delivery and for levels of fear .
CONCLUSIONS	In this large randomized controlled trial , a brief course in self-hypnosis improved the women 's childbirth experience .

###25007868
OBJECTIVE	To assess the impact of ASIR ( adaptive statistical iterative reconstruction ) and lower tube potential on dose reduction and image quality in chest computed tomography angiographies ( CTAs ) of patients with pulmonary embolism .
METHODS	CT data from 44 patients with pulmonary embolism were acquired using different protocols-Group A : 120 kV , filtered back projection , n = 12 ; Group B : 120 kV , 40 % ASIR , n = 12 ; Group C : 100 kV , 40 % ASIR , n = 12 and Group D : 80 kV , 40 % ASIR , n = 8 .
METHODS	Normalised effective dose was calculated ; image quality was assessed quantitatively and qualitatively .
RESULTS	Normalised effective dose in Group B was 33.8 % lower than in Group A ( p = 0.014 ) and 54.4 % lower in Group C than in Group A ( p < 0.001 ) .
RESULTS	Group A , B and C did not show significant differences in qualitative or quantitative analysis of image quality .
RESULTS	Group D showed significantly higher noise levels in qualitative and quantitative analysis , significantly more artefacts and decreased overall diagnosability .
RESULTS	Best results , considering dose reduction and image quality , were achieved in Group C.
CONCLUSIONS	The combination of ASIR and lower tube potential is an option to reduce radiation without significant worsening of image quality in the diagnosis of pulmonary embolism .
CONCLUSIONS	Iterative algorithms and lowering of tube potential reduce radiation without compromising interpretability 40 % ASIR and 100 kV tube potential led to a 54.4 % dose reduction 40 % ASIR and 80 kV tube potential led to significantly worse image quality .

###25239216
OBJECTIVE	We evaluated the effects of carbohydrate ( CHO ) supplementation on markers of bone turnover in elite runners .
METHODS	Twenty-four male runners were randomly assigned to two groups -- a CHO and a control ( CON ) group -- using a double-blind design .
METHODS	The participants were submitted to an overload training program ( days 1-8 ) , followed by a high-intensity intermittent running protocol ( 10800 m ) on day 9 .
METHODS	They received a maltodextrin solution ( CHO group ) or a placebo solution as the CON equivalent , before , during , and after these protocols .
RESULTS	After 8 days of intensive training , baseline levels of osteocalcin ( OC ) decreased in both CHO and CON groups ( before : 28.83.6 and 26.62.4 ng/ml , after : 24.83.0 and 21.91.6 ng/ml , respectively , p < 0.01 ) .
RESULTS	On day 9 , at 80 min of the recovery period , carboxy-terminal of telopeptide type I collagen ( CTX ) serum concentration was suppressed in the CHO group ( 0.30.1 ng/ml ) vs. 0.60.0 ng/ml for the CON group ( p < 0.01 ) .
RESULTS	CHO supplementation was effective in decreasing CTX levels from baseline to recovery ( 0.50.1 ng/mL to 0.30.1 ng/mL , p < 0.001 ) , while an increase from 0.40.0 ng/mL to 0.60.0 ng/mL ( p < 0.001 ) was observed in the CON group .
CONCLUSIONS	CHO beverage ingestion attenuated the exercise-induced increase in CTX concentration , suggesting that CHO supplementation is a potential strategy to prevent bone damage in athletes .

###24274891
OBJECTIVE	To evaluate effects of quaternary benzo ( c ) phenanthridine alkaloids ( QBAs ) against Salmonella spp and determine effects on growth performance , organism shedding , and gastrointestinal tract integrity in pigs inoculated with Salmonella enterica serovar Typhimurium .
METHODS	36 Salmonella isolates and twenty 5-week-old pigs .
METHODS	Minimum inhibitory concentration of QBAs against the Salmonella isolates was determined .
METHODS	Pigs were allocated to 4 groups and inoculated with Salmonella organisms .
METHODS	Pigs received diets supplemented with 1.5 g of QBAs/1 ,000 kg of feed , 0.75 g of QBAs/1 ,000 kg of feed , or 59.4 g of chlortetracycline/1 ,000 kg of feed or a nonsupplemented ( control ) diet .
METHODS	Pigs were weighed on day 0 and then weekly for 40 days .
METHODS	Fecal samples were collected to quantify Salmonella organisms .
METHODS	Gastrointestinal tract integrity was evaluated by measuring transepithelial resistance .
RESULTS	In vitro , 9 of 36 ( 25 % ) Salmonella isolates were inhibited at 90 g of QBAs/mL ; all 36 were inhibited at 179 g of QBAs/mL .
RESULTS	Diets containing QBAs significantly decreased Salmonella spp shedding ; shedding was lower 40 days after inoculation for pigs fed diets containing QBAs or chlortetracycline than for pigs fed the control diet .
RESULTS	Growth performance was similar for pigs fed diets containing QBA or chlortetracycline .
RESULTS	Gastrointestinal tract integrity was improved in pigs fed the diet containing 1.5 g of QBAs/1 ,000 kg of feed .
CONCLUSIONS	QBAs and chlortetracycline decreased Salmonella spp shedding but did not differ with regard to growth performance .
CONCLUSIONS	Gastrointestinal tract integrity was better , albeit not significantly , in pigs fed diets containing QBAs .
CONCLUSIONS	Further investigation into the role of QBAs and their mechanism as an immunomodulator is necessary .

###24353124
OBJECTIVE	Carbon dioxide ( CO2 ) insufflation has previously been shown to have advantages over air insufflation in terms of procedure-related pain and oral insertion depth during double-balloon enteroscopy .
OBJECTIVE	The aim of this prospective study was to evaluate the performance of CO2 vs. air insufflation during single-balloon enteroscopy .
METHODS	This study was a randomized European multicenter trial ( ClinicalTrials.gov : NCT01524055 ) .
METHODS	Patients and endoscopists were blinded to the type of insufflation gas used .
METHODS	Patient discomfort during and after the procedure was scored using a visual analog scale .
RESULTS	A total of 107 patients were enrolled in the study ( 52 in the CO2 group and 55 in the air group ) .
RESULTS	Patient characteristics were comparable in both groups .
RESULTS	The mean ( SD ) oral intubation depth was not significantly deeper in the CO2 group vs. the air group ( 25480 vs. 23855 cm ; P = 0.726 ) .
RESULTS	However , in patients with previous abdominal surgery , oral intubation depth was significantly higher in the CO2 group compared with the air group ( 25884 vs. 19242 cm ; P < 0.05 ) .
RESULTS	In patients undergoing SBE via the anal approach , CO2 showed no significant difference in intubation depth compared with air insufflation ( 8667 vs. 11068 cm ; P = 0.155 ) .
RESULTS	The diagnostic yield was comparable ( CO2 67 % ; air 73 % ) .
RESULTS	Procedure times , dosage of sedation , and therapeutic interventions did not differ between the two groups .
RESULTS	Patients in the CO2 group reported less pain than those in the air group .
CONCLUSIONS	This study demonstrated an advantage of using CO2 insufflation during single-balloon enteroscopy in patients with a history of previous abdominal surgery .
CONCLUSIONS	Overall , single-balloon enteroscopy was a well-tolerated procedure that may benefit from the use of CO2 insufflation to reduce post-procedural pain .

###24637997
OBJECTIVE	In platinum-resistant ovarian cancer ( OC ) , single-agent chemotherapy is standard .
OBJECTIVE	Bevacizumab is active alone and in combination .
OBJECTIVE	AURELIA is the first randomized phase III trial to our knowledge combining bevacizumab with chemotherapy in platinum-resistant OC .
METHODS	Eligible patients had measurable/assessable OC that had progressed < 6 months after completing platinum-based therapy .
METHODS	Patients with refractory disease , history of bowel obstruction , or > two prior anticancer regimens were ineligible .
METHODS	After investigators selected chemotherapy ( pegylated liposomal doxorubicin , weekly paclitaxel , or topotecan ) , patients were randomly assigned to single-agent chemotherapy alone or with bevacizumab ( 10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks ) until progression , unacceptable toxicity , or consent withdrawal .
METHODS	Crossover to single-agent bevacizumab was permitted after progression with chemotherapy alone .
METHODS	The primary end point was progression-free survival ( PFS ) by RECIST .
METHODS	Secondary end points included objective response rate ( ORR ) , overall survival ( OS ) , safety , and patient-reported outcomes .
RESULTS	The PFS hazard ratio ( HR ) after PFS events in 301 of 361 patients was 0.48 ( 95 % CI , 0.38 to 0.60 ; unstratified log-rank P < .001 ) .
RESULTS	Median PFS was 3.4 months with chemotherapy alone versus 6.7 months with bevacizumab-containing therapy .
RESULTS	RECIST ORR was 11.8 % versus 27.3 % , respectively ( P = .001 ) .
RESULTS	The OS HR was 0.85 ( 95 % CI , 0.66 to 1.08 ; P < .174 ; median OS , 13.3 v 16.6 months , respectively ) .
RESULTS	Grade 2 hypertension and proteinuria were more common with bevacizumab .
RESULTS	GI perforation occurred in 2.2 % of bevacizumab-treated patients .
CONCLUSIONS	Adding bevacizumab to chemotherapy statistically significantly improved PFS and ORR ; the OS trend was not significant .
CONCLUSIONS	No new safety signals were observed .

###24884504
BACKGROUND	Tissue inhibitor of metalloproteinases-1 ( TIMP-1 ) has anti-apoptotic functions , which may protect TIMP-1 positive cancer cells from the effects of chemotherapy such as docetaxel and gemcitabine .
BACKGROUND	The purpose of the present study was to evaluate TIMP-1 immunoreactivity as a prognostic and predictive marker in advanced breast cancer patients receiving docetaxel ( D ) or gemcitabine plus docetaxel ( GD ) .
METHODS	Patients with locally advanced or metastatic breast cancer who were assigned to D or GD by participation in a randomized phase III trial were included in the study .
METHODS	Assessment of TIMP-1 status was performed retrospectively on primary tumor whole-tissue sections by immunohistochemistry and tumor samples were considered positive if epithelial breast cancer cells were stained by the anti-TIMP-1 monoclonal antibody VT7 .
METHODS	Time to progression ( TTP ) was the primary endpoint .
METHODS	Overall survival ( OS ) and response rate ( RR ) were secondary endpoints .
METHODS	Associations between TIMP-1 status and outcome after chemotherapy were analyzed by Kaplan-Meier estimates and Cox proportional hazards regression models .
RESULTS	TIMP-1 status was available from 264 of 337 patients and 210 ( 80 % ) of the tumors were classified as cancer cell TIMP-1 positive .
RESULTS	No significant difference for TTP between TIMP-1 positive versus TIMP-1 negative patients was observed in multivariate analysis , and RR did not differ according to TIMP-1 status .
RESULTS	However , patients with TIMP-1 positive tumors had a significant reduction in OS events ( hazard ratio = 0.71 , 95 % confidence interval ( CI ) = 0.52-0 .98 , P = 0.03 ) .
RESULTS	Additionally , a borderline significant interaction for OS was observed between TIMP-1 status and benefit from GD compared to D ( Pinteraction = 0.06 ) such that median OS increased by nine months for TIMP-1 negative patients receiving GD .
CONCLUSIONS	TIMP-1 status was an independent prognostic factor for OS but not TTP in patients with advanced breast cancer receiving either D or GD .
CONCLUSIONS	There was no statistically significant interaction between TIMP-1 status and treatment , but a trend towards an incremental OS from the addition of gemcitabine to docetaxel in patients with TIMP-1 negative tumors suggests further investigation .

###25143179
OBJECTIVE	Cellulitis is a common and costly problem , often diagnosed in the outpatient setting .
OBJECTIVE	Many cutaneous conditions may clinically mimic cellulitis , but little research has been done to assess the magnitude of the problem .
OBJECTIVE	To determine if obtaining dermatology consultations in the outpatient primary care setting could assist in the diagnosis of pseudocellulitic conditions and reduce the rate of unnecessary antibiotic use .
METHODS	Nonblinded randomized clinical trial of competent adults who were diagnosed as having cellulitis by their primary care physicians ( PCPs ) , conducted at outpatient internal medical primary care offices affiliated with a large academic medical center .
METHODS	Outpatient dermatology consultation .
METHODS	Primary outcomes were final diagnosis , antibiotic use , and need for hospitalization .
RESULTS	A total of 29 patients ( 12 male and 17 female ) were enrolled for participation in this trial .
RESULTS	Nine patients were randomized to continue with PCP management ( control group ) , and 20 patients were randomized to receive a dermatology consultation ( treatment group ) .
RESULTS	Of the 20 patients in the dermatology consultation group , 2 ( 10 % ) were diagnosed as having cellulitis .
RESULTS	In the control group , all 9 patients were diagnosed as having cellulitis by PCPs , but dermatologist evaluation determined that 6 ( 67 % ) of these patients had a psuedocellulitis rather than true infection .
RESULTS	All 9 patients ( 100 % ) in the control group were treated for cellulitis with antibiotics vs 2 patients ( 10 % ) in the treatment group ( P < .001 ) .
RESULTS	One patient in the control group was hospitalized .
RESULTS	All patients in the treatment group reported improvement of their cutaneous condition at the 1-week follow-up examination .
CONCLUSIONS	Dermatology consultation in the primary care setting improves the diagnostic accuracy of suspected cellulitis and decreases unnecessary antibiotic use in patients with pseudocellulitic conditions .
CONCLUSIONS	Obtaining an outpatient dermatology consultation may be a cost-effective strategy that improves quality of care .
BACKGROUND	clinicaltrials.gov Identifier : NCT01795092 .

###25083614
BACKGROUND	We conducted a randomized and unblinded 2 2 sequential-factorial trial , composed of an induction arm ( part 1 ) comparing single-dose ( SD ) versus divided-dose rabbit antithymocyte globulin ( rATG ) , and a maintenance arm ( part 2 ) comparing tacrolimus minimization versus withdrawal .
BACKGROUND	We report the long-term safety and efficacy of SD-rATG induction in the context of early steroid withdrawal and tacrolimus minimization or withdrawal .
METHODS	Patients ( n = 180 ) received 6 mg/kg rATG , SD or four alternate-day doses ( 1.5 mg/kg/dose ) , with early steroid withdrawal and tacrolimus or sirolimus maintenance .
METHODS	After 6 months targeted maintenance levels were tacrolimus , 2 to 4 ng/mL and sirolimus , 4 to 6 ng/mL or , if calcineurin inhibitor-withdrawn , sirolimus 8 to 12 ng/mL with mycophenolate mofetil 2 g two times per day .
METHODS	Primary endpoints were renal function ( abbreviated modification of diet in renal disease ) and chronic graft histopathology ( Banff ) .
METHODS	Secondary endpoints included patient survival , graft survival , biopsy-proven rejection , and infectious or noninfectious complications .
RESULTS	Follow-up averaged longer than 4 years .
RESULTS	Tacrolimus or sirolimus and mycophenolate mofetil exposure was identical between groups .
RESULTS	The SD-rATG associated with improved renal function ( 2-36 months ; P < 0.001 ) in deceased donor recipients .
RESULTS	The SD-rATG associated with quicker lymphocyte , CD4 T cell , and CD4-CD8 recovery and fewer infections .
RESULTS	Cox multivariate hazard modeling showed divided-dose-rATG ( P = 0.019 ) , deceased donor ( P = 0.003 ) , serious infection ( P = 0.0.018 ) , and lower lymphocyte count ( P = 0.001 ) associated with increased mortality .
RESULTS	Patients with all four covariates showed a 27-fold increased likelihood of death ( P = 0.00002 ) .
RESULTS	Chronic graft histopathology , rejection rates , and death-censored graft survival were not significantly different between groups .
CONCLUSIONS	The SD-rATG induction improves the 3-year renal function in recipients of deceased donor kidneys .
CONCLUSIONS	This benefit , along with possibly improved patient survival and fewer infections suggest that how rATG is administered may impact its efficacy and safety .

###24947443
OBJECTIVE	Saxagliptin reduced glycated hemoglobin ( HbA1c ) , fasting plasma glucose ( FPG ) , and postprandial glucose ( PPG ) in Asian patients with type 2 diabetes mellitus ( T2DM ) .
OBJECTIVE	To understand the physiology of this effect , indices of - and - cell function were measured in a subpopulation of Chinese patients following a noodle mixed-meal tolerance test .
METHODS	Data from Chinese patients were pooled from two phase 3 , 24-week studies of saxagliptin 5mg/d as monotherapy in drug-naive patients and as add-on to metformin in patients inadequately controlled with metformin alone .
METHODS	The end points for - and - cell function were change from baseline in C-peptide , insulin , and glucagon areas under the curve from 0 to 180 min ( AUC0-180 ) , insulinogenic index , and insulin sensitivity from Matsuda index after a mixed meal .
METHODS	Also glycemic variables , HbA1c , FPG , and PPG ( AUC0-180 ) , and homeostasis model assessment ( HOMA ) 2 were measured .
RESULTS	At 24 weeks , greater improvements in adjusted mean change from baseline HbA1c ( difference vs placebo [ 95 % CI ] , -0.33 % [ -0.50 % , -0.17 % ] , [ -4 ( -5.5 , -1.9 ) mmol/mol ] , P < 0.0001 ) , FPG ( -0.41 [ -0.78 , -0.03 ] mmol/L , P = 0.03 ) , PPG AUC0-180 ( -168 [ -245 , -91.8 ] mmol min/L , P < 0.0001 ) , C-peptide AUC0-180 ( 19.7 [ 5.2 , 34.2 ] nmol min/L , P = 0.008 ) , insulinogenic index ( 0.06 % [ 0.02 % , 0.09 % ] , P = 0.002 ) , and greater suppression of glucagon secretion ( glucagon AUC0-180 , -322 [ -493.6 , -150.7 ] pmol min/L , P = 0.0003 ) were observed with saxagliptin versus placebo .
CONCLUSIONS	In Chinese patients with T2DM , saxagliptin as monotherapy or as add-on to metformin improved glycemic control by modulating - and - cell function .

###24787908
OBJECTIVE	Low plasma vitamin D levels have been associated with heart failure ( HF ) .
OBJECTIVE	This research attempts to explain the role of vitamin D supplementation on myocardial function in elderly patients with HF .
RESULTS	Twenty-three chronic HF patients were randomized in a small parallel group , double-blind , placebo-controlled trial .
RESULTS	All patients , with a mean age of 74 years and vitamin D levels < 30 ng/mL , received 800,000 IU ( 4000 IU/daily ) of cholecalciferol or placebo for 6 months .
RESULTS	The outcomes measured at baseline and after 6 months were ejection fraction ( EF ) and other echocardiography parameters , carboxyterminal propeptide of procollagen type I ( PIP ) , natriuretic peptides , lipid profile , renin , parathyroid hormone , blood pressure , and body mass index ( BMI ) .
RESULTS	In 13 patients under active treatment for 6 months , mean plasma 25-hydroxy vitamin D concentrations ( 15.51 vs. -1.40 ng/mL , p < 0.001 ) and plasma calcium ( from 9.3 to 9.6 mmol/L , p < 0.05 ) increased significantly .
RESULTS	However , other biomarkers of bone metabolism did not differ between the treatment and placebo groups .
RESULTS	EF increased significantly in the intervention group ( 6.71 vs. -4.3 % ; p < 0.001 ) , and the serum concentration of PIP increased only in the placebo group after 6 months ( 1140.98 vs. -145 mcg/L ; p < 0.05 ) .
RESULTS	Systolic blood pressure was lower after 6 months of cholecalciferol treatment ( from 129.6 to 122.7 mm Hg , p < 0.05 ) .
RESULTS	No significant variations were observed for other parameters .
CONCLUSIONS	Six months of vitamin D supplementation significantly improves EF in elderly patients with HF and vitamin D deficiency .

###24658473
BACKGROUND	Complex regional pain syndrome ( CRPS ) is characterized by signs and symptoms of peripheral inflammation , which leads to peripheral neural sensitization associated most frequently ( in about 70 % ) with blunt pressure hyperalgesia .
BACKGROUND	Therefore , we hypothesized that treatment of CRPS patients with a selective COX-2-inhibitor would alleviate the abnormally low pressure pain threshold ( PPT ) and reduce pain intensity and edema .
METHODS	Twenty patients with CRPS type I ( n = 16 ) and II of the upper limb and abnormally low PPT were double-blind randomised into 2 groups of 10 patients each to receive a 2-day intravenous treatment of either 80 mg parecoxib per day ( group I ) or placebo ( NaCl 0.9 % , group II ) .
METHODS	Standardized quantitative sensory testing ( QST ) using the DFNS protocol was performed before and after treatment .
METHODS	Pain intensity ( NRS 0 - 10 ) ; circumferences of the fingers II , IV , and V ( mm ) ; PPT ( kPa , thenar/hypothenar ) ; and adverse events were recorded daily .
METHODS	Wilcoxon-test , Mann-Whitney-U-test , Friedman-test , Fisher-test , significance level : P < 0.05 .
METHODS	Proof of concept trial performed in randomized , placebo-controlled , double blind style .
METHODS	Pain Management Center in Germany .
RESULTS	There were no group differences in PTT or other QST parameters .
RESULTS	After treatment , PPT decreased insignificantly in group I ( median [ range ] ; before : 224.0 [ 121.0 - 52937 ] kPa , afterwards : 186.4 [ 101.4 - 526.5 ] kPa ) and increased insignificantly in group II ( before : 207.6 [ 170.0 - 320.5 ] kPa ; afterwards : 235.4 [ 163.5 - 349.9 ] kPa ) .
RESULTS	Pain scores and finger circumferences remained unchanged in both groups .
CONCLUSIONS	Due to difficulty in recruitment the trial was closed after inclusion of 20 patients .
CONCLUSIONS	In the present proof-of-concept trial , short-term treatment with the selective COX-2-inhibitor parecoxib influenced neither PPT nor edema or pain .
CONCLUSIONS	COX-2 might be less important than previously assumed .
CONCLUSIONS	However , the results are limited due to the small number of patients , short-term treatment , and focus on the PPT , which could have led to false negative results of the present study and covered the expected therapeutic effect .

###24410736
BACKGROUND	Repeated exposure to peritoneal dialysis ( PD ) solutions contributes to cumulative intraperitoneal inflammation and peritoneal injury .
BACKGROUND	The present study aimed to explore the capacity of dialysate interleukin-6 ( IL-6 ) to a ) predict peritoneal membrane function and peritonitis in incident PD patients , and b ) to evaluate the influence of neutral pH , low glucose degradation product ( GDP ) PD solution on dialysate IL-6 levels .
METHODS	The study included 88 incident participants from the balANZ trial who had completed 24-months of follow-up .
METHODS	Change in peritoneal solute transport rate ( PSTR ) and peritonitis were primary outcome measures , and the utility of IL-6 and IL-6 appearance rate ( IL-6 AR ) in predicting these outcomes was analyzed using multilevel linear regression and Cox proportional hazards models , respectively .
METHODS	Sensitivity analyses were performed by analyzing outcomes in a peritonitis-free cohort ( n = 56 ) .
RESULTS	Dialysate IL-6 concentration significantly increased from baseline to 24months ( mean difference 19.07 pg/mL ; P < 0.001 ) but was not affected by the type of PD solution received ( P = 0.68 ) .
RESULTS	An increase in PSTR from baseline was associated with higher levels of IL-6 ( P = 0.004 ) , the use of standard solutions ( P = 0.005 ) and longer PD duration ( P < 0.001 ) .
RESULTS	Baseline IL-6 level was not associated with a shorter time to first peritonitis ( adjusted hazard ratio 1.00 , 95 % CI 0.99-1 .00 , P = 0.74 ) .
RESULTS	Analysis of IL-6 AR as well as sensitivity analyses in a peritonitis-free cohort yielded comparable results .
CONCLUSIONS	Dialysate IL-6 concentration increased with longer PD duration and was a significant , independent predictor of PSTR .
CONCLUSIONS	The use of biocompatible PD solutions exerted no significant effect on dialysate IL-6 levels but did abrogate the increase in PSTR associated with standard PD solutions .
CONCLUSIONS	This is the first study to examine the impact of biocompatible solutions on the utility of IL-6 in predicting PSTR and peritonitis .

###24224997
BACKGROUND	The TARGIT-A trial compared risk-adapted radiotherapy using single-dose targeted intraoperative radiotherapy ( TARGIT ) versus fractionated external beam radiotherapy ( EBRT ) for breast cancer .
BACKGROUND	We report 5-year results for local recurrence and the first analysis of overall survival .
METHODS	TARGIT-A was a randomised , non-inferiority trial .
METHODS	Women aged 45 years and older with invasive ductal carcinoma were enrolled and randomly assigned in a 1:1 ratio to receive TARGIT or whole-breast EBRT , with blocks stratified by centre and by timing of delivery of targeted intraoperative radiotherapy : randomisation occurred either before lumpectomy ( prepathology stratum , TARGIT concurrent with lumpectomy ) or after lumpectomy ( postpathology stratum , TARGIT given subsequently by reopening the wound ) .
METHODS	Patients in the TARGIT group received supplemental EBRT ( excluding a boost ) if unforeseen adverse features were detected on final pathology , thus radiotherapy was risk-adapted .
METHODS	The primary outcome was absolute difference in local recurrence in the conserved breast , with a prespecified non-inferiority margin of 25 % at 5 years ; prespecified analyses included outcomes as per timing of randomisation in relation to lumpectomy .
METHODS	Secondary outcomes included complications and mortality .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00983684 .
RESULTS	Patients were enrolled at 33 centres in 11 countries , between March 24 , 2000 , and June 25 , 2012.1721 patients were randomised to TARGIT and 1730 to EBRT .
RESULTS	Supplemental EBRT after TARGIT was necessary in 152 % [ 239 of 1571 ] of patients who received TARGIT ( 216 % prepathology , 36 % postpathology ) .
RESULTS	3451 patients had a median follow-up of 2 years and 5 months ( IQR 12-52 months ) , 2020 of 4 years , and 1222 of 5 years .
RESULTS	The 5-year risk for local recurrence in the conserved breast was 33 % ( 95 % CI 21-51 ) for TARGIT versus 13 % ( 07-25 ) for EBRT ( p = 0042 ) .
RESULTS	TARGIT concurrently with lumpectomy ( prepathology , n = 2298 ) had much the same results as EBRT : 21 % ( 11-42 ) versus 11 % ( 05-25 ; p = 031 ) .
RESULTS	With delayed TARGIT ( postpathology , n = 1153 ) the between-group difference was larger than 25 % ( TARGIT 54 % [ 30-97 ] vs EBRT 17 % [ 06-49 ] ; p = 0069 ) .
RESULTS	Overall , breast cancer mortality was much the same between groups ( 26 % [ 15-43 ] for TARGIT vs 19 % [ 11-32 ] for EBRT ; p = 056 ) but there were significantly fewer non-breast-cancer deaths with TARGIT ( 14 % [ 08-25 ] vs 35 % [ 23-52 ] ; p = 00086 ) , attributable to fewer deaths from cardiovascular causes and other cancers .
RESULTS	Overall mortality was 39 % ( 27-58 ) for TARGIT versus 53 % ( 39-73 ) for EBRT ( p = 0099 ) .
RESULTS	Wound-related complications were much the same between groups but grade 3 or 4 skin complications were significantly reduced with TARGIT ( four of 1720 vs 13 of 1731 , p = 0029 ) .
CONCLUSIONS	TARGIT concurrent with lumpectomy within a risk-adapted approach should be considered as an option for eligible patients with breast cancer carefully selected as per the TARGIT-A trial protocol , as an alternative to postoperative EBRT .
BACKGROUND	University College London Hospitals ( UCLH ) / UCL Comprehensive Biomedical Research Centre , UCLH Charities , National Institute for Health Research Health Technology Assessment programme , Ninewells Cancer Campaign , National Health and Medical Research Council , and German Federal Ministry of Education and Research .

###24906857
OBJECTIVE	We evaluated the effect of intravitreal triamcinolone acetonide ( IVTA ) or intravitreal bevacizumab ( IVB ) on subfoveal choroidal thickness ( SFCT ) in eyes with diabetic macular edema ( DME ) .
METHODS	In this prospective , randomized , interventional comparative study , 51 DME eyes of 51 patients were randomized to receive either IVTA or IVB .
METHODS	The central macular thickness ( CMT ) and SFCT were determined by optical coherence tomography at 24 hours , 7 days , and 4 , 8 , and 12 weeks .
METHODS	The SFCT at 1500 and 3000 m nasal or temporal to the central fovea also was measured .
METHODS	The values obtained before were compared to those obtained 12 weeks after the injections .
RESULTS	The eyes were randomly assigned to the IVTA ( 25 eyes ) and IVB ( 26 eyes ) groups .
RESULTS	The SFCT was reduced significantly in the IVTA group from 24 hours to 12 weeks .
RESULTS	The average SD of the SFCT expressed as the ratio to baseline thickness decreased to 94.8 % 5.6 % ( P < 0.01 ) at 24 hours after IVTA and remained unchanged up to 12 weeks ( 91.8 % 10.5 % , P < 0.01 , Wilcoxon signed-rank test ) .
RESULTS	In the IVB group , no significant difference was found in the SFCT after IVB for 12 weeks .
RESULTS	The CMT decreased significantly in both groups from 24 hours to 4 weeks ; however , the decrease was not significant at 8 weeks or later in the IVB group .
CONCLUSIONS	The decrease in choroidal thickness in eyes with DME after IVTA suggests that the choroidal pathology in diabetic retinopathy might be due to steroid-sensitive factors rather than vascular endothelial growth factor .
CONCLUSIONS	( www.umin.ac.jp/ctr number , clinical trials number UMIN000009854 . )

###24930327
BACKGROUND	Metatarsal fractures are managed using different types of forefoot offloading orthosis .
BACKGROUND	Theaim of this prospective study was to evaluate the clinical and pedographic results of a vacuum shoe system in comparison to a forefoot unloading shoe .
METHODS	20 patients ( 14 women/6 men -- age : 36.4 + / - 14.1 years ) were prospectively included in the study .
METHODS	The patients were followed up at four different time points .
METHODS	Detailed clinical and radiological examinations were carried out , functional scores were measured and a pedographic assessment was performed .
RESULTS	Between the study groups no differences were seen in functional scoring .
RESULTS	A complete bony healing was achieved within the 3 months of followup in all patients .
RESULTS	The heelstrike to heelstrike time was without significant differences in the pedographic analysis .
RESULTS	Adequate forefoot unloading was achieved with both orthosis .
RESULTS	The load sharing between fore - , mid - and hindfoot showed no significant differences in the pedographic analysis .
RESULTS	Patients ' satisfaction was rated with higher values for the vacuum shoe system , but without significance .
CONCLUSIONS	Both shoe systems show an adequate unloading of the forefoot .
CONCLUSIONS	Therefore both orthosis may be used for the treatment of metatarsal fractures .

###25053766
BACKGROUND	Research indicates that music therapy can improve social behaviors and joint attention in children with Autism Spectrum Disorder ( ASD ) ; however , more research on the use of music therapy interventions for social skills is needed to determine the impact of group music therapy .
OBJECTIVE	To examine the effects of a music therapy group intervention on eye gaze , joint attention , and communication in children with ASD .
METHODS	Seventeen children , ages 6 to 9 , with a diagnosis of ASD were randomly assigned to the music therapy group ( MTG ) or the no-music social skills group ( SSG ) .
METHODS	Children participated in ten 50-minute group sessions over a period of 5 weeks .
METHODS	All group sessions were designed to target social skills .
METHODS	The Social Responsiveness Scale ( SRS ) , the Autism Treatment Evaluation Checklist ( ATEC ) , and video analysis of sessions were used to evaluate changes in social behavior .
RESULTS	There were significant between-group differences for joint attention with peers and eye gaze towards persons , with participants in the MTG demonstrating greater gains .
RESULTS	There were no significant between-group differences for initiation of communication , response to communication , or social withdraw/behaviors .
RESULTS	There was a significant interaction between time and group for SRS scores , with improvements for the MTG but not the SSG .
RESULTS	Scores on the ATEC did not differ over time between the MTG and SSG .
CONCLUSIONS	The results of this study support further research on the use of music therapy group interventions for social skills in children with ASD .
CONCLUSIONS	Statistical results demonstrate initial support for the use of music therapy social groups to develop joint attention .

###25178072
OBJECTIVE	to assess efficacy , safety , and tolerability of 4 fixed irbesartan/amlodipine combinations in hypertensive patients resistant to monotherapy with 150 mg irbesartan or 5 mg amlodipine in a 16 week prospective open uncontrolled randomized multicenter study .
METHODS	We included in this study 158 patients with essential arterial hypertension ( AH ) ( mean age 57.6 10.1 years , 119 women ) receiving monotherapy with 150 mg irbesartan ( n = 78 ; 49.4 % ) or 5 mg amlodipine ( n = 80 ; 50.6 % ) .
METHODS	Patients not achieving target arterial pressure ( AP ) < 140/90 mm ( n = 149 ) Hg were given fixed irbesartan/amlodipine combination 150/5 mg .
METHODS	If target AP was not achieved patients were randomized to 150/10 or 300/5 mg combinations .
METHODS	If necessary after 4 more weeks these doses were increased to maximal ( 300/10 mg ) .
METHODS	Thus 4 fixed irbesartan/amlodipine combinations were used : 150/5 , 150/10 , 300/5 , 300/10 mg .
METHODS	Primary criterion of efficacy was portion of patients with target AP at last visit .
METHODS	Safety was assessed by presence of unfavorable events , clinical and laboratory parameters .
RESULTS	After 16 weeks 43 , 23.5 , 23.5 and 8.7 % of patients received 150/5 , 150/10 , 300/5 and 300/10 mg combinations , respectively .
RESULTS	At final visit 93.3 % of patients had AP < 140/90 mm Hg .
RESULTS	Mean AP lowering in the total group was -21.7 9.1 / -10.9 10.8 mm Hg ( < 0.0001 ) .
RESULTS	There were 2 cases of ankle edema ( 5.7 % ) but no withdrawals due to unfavorable events .
RESULTS	There were no differences between 4 dosing regimens in laboratory and clinical parameters of safety and tolerability .
CONCLUSIONS	In patients with AH not achieving target AP on monotherapy with irbesartan 150 or amlodipine 5 mg administration of irbesartan/amlodipine combination with possibility of dose titration using 4 fixed combinations was effective in 93.3 % of patients , resulted in significant systolic and diastolic AP lowering in all therapeutic groups , was well tolerated and safe .

###24249680
OBJECTIVE	To determine if a pharmacist-initiated multidisciplinary strategy provides value for money compared to usual care in participants with previously undiagnosed knee osteoarthritis .
METHODS	Pharmacies were randomly allocated to provide either 1 ) usual care and a pamphlet or 2 ) intervention care , which consisted of education , pain medication management by a pharmacist , physiotherapy-guided exercise , and communication with the primary care physician .
METHODS	Costs and quality-adjusted life-years ( QALYs ) were determined for patients assigned to each treatment and incremental cost-effectiveness ratios ( ICERs ) were determined .
RESULTS	From the Ministry of Health perspective , the average patient in the intervention group generated slightly higher costs compared with usual care .
RESULTS	Similar findings were obtained when using the societal perspective .
RESULTS	The intervention resulted in ICERs of $ 232 ( 95 % confidence interval [ 95 % CI ] -1,530 , 2,154 ) per QALY gained from the Ministry of Health perspective and $ 14,395 ( 95 % CI 7,826 , 23,132 ) per QALY gained from the societal perspective , compared with usual care .
CONCLUSIONS	A pharmacist-initiated , multidisciplinary program was good value for money from both the societal and Ministry of Health perspectives .

###25532076
BACKGROUND	This Phase III , randomized , double-blind , placebo-controlled study investigated the efficacy and tolerability of flexibly-dosed cariprazine in patients with acute manic or mixed episodes associated with bipolar I disorder .
METHODS	Patients were randomized to 3 weeks of double-blind treatment with cariprazine 3-12mg / day ( n = 158 ) or placebo ( n = 154 ) .
METHODS	The primary efficacy parameter was change from baseline to Week 3 in Young Mania Rating Scale ( YMRS ) total score .
METHODS	The secondary efficacy parameter was change from baseline to Week 3 in Clinical Global Impressions-Severity ( CGI-S ) score .
RESULTS	Mean change from baseline to Week 3 in YMRS total score was significantly greater for patients receiving cariprazine 3-12mg / day versus placebo ( P = 0.0004 ) .
RESULTS	Significant differences between groups in YMRS total score mean change were observed by Day 4 ( first postbaseline assessment ) and maintained throughout double-blind treatment ( all assessments , P < 0.01 ) .
RESULTS	Cariprazine also demonstrated statistically significant superiority over placebo on YMRS response ( 50 % improvement : cariprazine , 58.9 % ; placebo , 44.1 % ; P = 0.0097 ) and remission ( YMRS total score12 : cariprazine , 51.9 % ; placebo , 34.9 % ; P = 0.0025 ) and mean change in CGI-S ( P = 0.0027 ) score and Positive and Negative Syndrome Scale ( PANSS ) ( P = 0.0035 ) total score .
RESULTS	The most common cariprazine-related ( 10 % and twice placebo ) treatment emergent adverse events ( TEAEs ) were akathisia , extrapyramidal disorder , tremor , dyspepsia , and vomiting .
RESULTS	Mean change from baseline in metabolic parameters were generally small and similar between groups .
CONCLUSIONS	Lack of active comparator arm ; short duration of study .
CONCLUSIONS	In this study , cariprazine 3-12mg / day was effective and generally well tolerated in the treatment of manic and mixed episodes associated with bipolar I disorder .

###24634929
OBJECTIVE	Fasting period before surgery may change metabolic status of the patient and have influence on perioperative stress response .
OBJECTIVE	The aim of the study was to investigate effects of preoperative carbohydrate-rich beverage on stress response after laparoscopic cholecystectomy .
METHODS	Patients admitted for laparoscopic cholecystectomy were included into study and they were randomized into a group that was fed prior to surgery and in a group that was in the regime of nothing by mouth from the evening one day before surgery .
METHODS	Concentrations of C-reactive protein and cortisol , were measured before and subsequently up to 48 h postoperatively .
RESULTS	Postoperative serum C-reactive protein increased significantly in both groups , but the increase was more evident in the group with fasting protocol both 24 and 48 hours postoperatively .
RESULTS	In fed patients cortisol concentration measured in the afternoon immediately after the operation showed physiological decline .
RESULTS	In patients with fasting protocol postoperative cortisol values rise above the values measured in the morning .
CONCLUSIONS	Preoperative feeding has advantage over overnight fasting by reducing preoperative discomfort in patients after laparoscopic cholecystectomy .
CONCLUSIONS	In fed patients , smaller increase in C-reactive protein and better regulation of cortisol levels are an indicator of decreased perioperative stress response .

###25125014
OBJECTIVE	Proximal cerebral protection devices have been developed as an alternative to filter protection devices for reducing neurological complications during carotid artery stenting ( CAS ) .
OBJECTIVE	The aim of the present study was to evaluate the frequency of silent cerebral embolism after CAS using different cerebral embolic protection devices and the impact of silent cerebral embolism on neurocognitive function .
METHODS	One hundred consecutive patients who underwent CAS were enrolled .
METHODS	The patients were randomized to either proximal balloon occlusion or filter protection .
METHODS	Neurocognitive tests were performed before and six months after CAS .
METHODS	Cerebral embolisms were evaluated with diffusion-weighted magnetic resonance imaging ( DW-MRI ) .
RESULTS	The number and volume of new ischemic lesions found with DW-MRI were higher in the filter protection group than in the proximal balloon occlusion group .
RESULTS	According to our definition , nine ( 21 % ) patients in the balloon occlusion group and 16 ( 36 % ) patients in the filter protection group showed neurocognitive decline , and ten ( 23 % ) patients in the balloon occlusion group and four ( 9 % ) patients in the filter protection group showed neurocognitive improvement ( NS ) .
RESULTS	Regarding the group of patients with new cerebral ischemic lesions on DW-MRI , neurocognitive decline occurred in 14 ( 31 % ) of 45 patients with DW-MRI lesions and 11 ( 26 % ) of 43 patients without DW-MRI lesions ( NS ) .
CONCLUSIONS	Neurocognitive outcome after CAS is unpredictable ; both neurocognitive decline and improvement can occur .
CONCLUSIONS	In this study , the proximal balloon occlusion system significantly decreased cerebral microemboli during CAS compared to filter protection .
CONCLUSIONS	Cerebral microembolism was not found to be associated with neurocognitive decline .

###24528892
OBJECTIVE	Community-acquired pneumonia ( CAP ) is a leading cause of mortality , morbidity and hospital admission , which places strain on our healthcare system .
OBJECTIVE	Procalcitonin ( PCT ) is a biomarker of bacterial infection which may help gauge the severity and prognosis of patients with CAP .
OBJECTIVE	In addition to clinical predictors , PCT may assist in decisions pertaining to timing of discharge from hospital and the discontinuation of antibiotics .
OBJECTIVE	This study aimed to determine the predictive role of PCT measurement in reducing hospital admissions , length of stay ( LOS ) and antibiotic ( AB ) usage in patients with CAP .
METHODS	A prospective , single-blinded , externally controlled study of consenting adult patients admitted with CAP .
METHODS	PCT levels were obtained on day 1 and day 3 ( when indicated ) .
METHODS	Investigator-evaluated clinical parameters , together with results of PCT levels , determined the timing of oral AB switch and discharge from hospital .
METHODS	This process was compared against standard practice , but was not actually implemented , for the purpose of this study .
RESULTS	Sixty patients were included in the study .
RESULTS	The mean age was 66.5 21.2 years ( 56.3 % male ) .
RESULTS	The average Pneumonia Severity Index was 93 39 ( class IV ) and the median CURB-65 was 2 .
RESULTS	The mean LOS for the standard practice cohort was 5.3 4.6 days versus calculated LOS using the PCT guidance pathway of 3.7 2.8 days .
RESULTS	( P = 0.00006 ) .
CONCLUSIONS	Our study supports the hypothesis that by incorporation of PCT levels , hospital admission and LOS in patients with CAP can be reduced .
CONCLUSIONS	A randomised prospective clinical trial is planned in an attempt to help confirm these findings .

###24507437
OBJECTIVE	The aim of this single center study is to evaluate the effectiveness of performing ultrasound-guided thyroid fine-needle aspiration biopsies ( FNAB ) performed by the radiologist alone without an on-site cytopathologist .
METHODS	In this prospective randomized study , 203 patients with single nodules measuring 10mm or more underwent ultrasound-guided FNAB : 102 patients underwent FNAB performed by the radiologist accompanied by a cytopathologist ( control group ) ; 101 patients underwent FNAB by the radiologist alone ( study group ) .
METHODS	In both groups biopsy time , specimen adequacy ratio , total aspiration number , cytopathologist 's cytological diagnosis time ( t1 ) , cytopathologist 's total time consumption ( t2 ) were evaluated .
RESULTS	Mean total biopsy time was 8.74 2.31 min in the study group and was significantly shorter than the control group 's 11.97 6.75 min ( p = 0.004 ) .
RESULTS	The average number of aspirations per patient in the study group was 4.00 0 ; compared to the control group 's 3.56 1.23 this was significantly higher ( p = 0.001 ) .
RESULTS	t1 of the study group was 307.48 226.32 s ; compared to 350.14 247.64 s in the control group , there was no statistically significant difference ( p = 0.137 ) .
RESULTS	t2 of the study group was 672.93 270.45 s ; compared to the control group ( 707.03 258.78 s ) there was no statistically significant difference ( p = 0.360 ) .
RESULTS	Diagnostic adequacy of aspirated specimens was reassessed in the pathology laboratory .
RESULTS	In the study group , 84 out of 101 aspirations and in the control group 89 out of 102 aspirations was determined as adequate with no statistically significant difference ( p = 0.302 ) .
CONCLUSIONS	We believe that in centers where a cytopathologist is not available , ultrasound-guided thyroid FNAB can be adequately performed by an experienced radiologist who was effectively trained in smear preparation .

###24310049
OBJECTIVE	In the United States , use of oral opioid analgesics has been associated with increasing rates of addiction , abuse , and diversion .
OBJECTIVE	However , little is known about the recent national use of non-illicit prescription opioid analgesics ( those prescribed in a physician-patient relationship ) , the primary source of these drugs for the general US population .
OBJECTIVE	Our primary objective was to examine trends in the use of prescription opioid analgesics in the United States and to identify defining characteristics of patient users of prescribed opioids from 2000 to 2010 .
METHODS	We used the nationally representative Medical Expenditure Panel Survey to examine trends in prescription oral opioid analgesic use from 2000 to 2010 .
METHODS	We used survey design methods to make national estimates of adults ( 18 years and older ) who reported receiving an opioid analgesic prescription ( referred to as opioid users ) and used logistic regression to examine predictors of opioid analgesic use .
METHODS	Our primary outcome measures were national estimates of total users of prescription opioid analgesics and total number of prescriptions .
METHODS	Our secondary outcome was that of observing changes in the disability and health of the users .
RESULTS	The estimated total number of opioid analgesic prescriptions in the United States increased by 104 % , from 43.8 million in 2000 to 89.2 million in 2010 .
RESULTS	In 2000 , an estimated 7.4 % ( 95 % confidence interval , 6.9-7 .9 ) of adult Americans were prescription opioid users compared with 11.8 % ( 95 % confidence interval , 11.2-12 .4 ) in 2010 .
RESULTS	On the basis of estimates adjusted for changes in the general population , each year was associated with a 6 % increase in the likelihood of receiving an opioid prescription from 2000 to 2010 .
RESULTS	Despite the apparent increase in use , there were no demonstrable improvements in the age - or sex-adjusted disability and health status measures of opioid users .
CONCLUSIONS	The use of prescription opioid analgesics among adult Americans has increased in recent years , and this increase does not seem to be associated with improvements in disability and health status among users .
CONCLUSIONS	On a public health level , these data suggest that there may be an opportunity to reduce the prescribing of opioid analgesics without worsening of population health metrics .

###24565698
BACKGROUND	Although accumulating data support the efficacy of intramyocardial cell-based therapy to improve left ventricular ( LV ) function in patients with chronic ischemic cardiomyopathy undergoing CABG , the underlying mechanism and impact of cell injection site remain controversial .
BACKGROUND	Mesenchymal stem cells ( MSCs ) improve LV structure and function through several effects including reducing fibrosis , neoangiogenesis , and neomyogenesis .
OBJECTIVE	To test the hypothesis that the impact on cardiac structure and function after intramyocardial injections of autologous MSCs results from a concordance of prorecovery phenotypic effects .
RESULTS	Six patients were injected with autologous MSCs into akinetic/hypokinetic myocardial territories not receiving bypass graft for clinical reasons .
RESULTS	MRI was used to measure scar , perfusion , wall thickness , and contractility at baseline , at 3 , 6 , and 18 months and to compare structural and functional recovery in regions that received MSC injections alone , revascularization alone , or neither .
RESULTS	A composite score of MRI variables was used to assess concordance of antifibrotic effects , perfusion , and contraction at different regions .
RESULTS	After 18 months , subjects receiving MSCs exhibited increased LV ejection fraction ( +9.4 1.7 % , P = 0.0002 ) and decreased scar mass ( -47.5 8.1 % ; P < 0.0001 ) compared with baseline .
RESULTS	MSC-injected segments had concordant reduction in scar size , perfusion , and contractile improvement ( concordant score : 2.93 0.07 ) , whereas revascularized ( 0.5 0.21 ) and nontreated segments ( -0.07 0.34 ) demonstrated nonconcordant changes ( P < 0.0001 versus injected segments ) .
CONCLUSIONS	Intramyocardial injection of autologous MSCs into akinetic yet nonrevascularized segments produces comprehensive regional functional restitution , which in turn drives improvement in global LV function .
CONCLUSIONS	These findings , although inconclusive because of lack of placebo group , have important therapeutic and mechanistic hypothesis-generating implications .
BACKGROUND	http://clinicaltrials.gov/show/NCT00587990 .
BACKGROUND	Unique identifier : NCT00587990 .

###25613634
OBJECTIVE	To investigate the effect of supplementing qi , activating blood circulation and tonifying kidney therapy on the postoperative outcomes of patients undergoing lumber intervertebral disc herniation .
METHODS	From January 2010 to May 2012 , 120 patients with lumbar intervertebral disc herniation undergoing surgical treatment in Nanfang hospital were randomized into two equal groups to receive routine therapy ( control group ) and additional treatment with Yiqi Houxue Bushen Decoction ( treatment group ) .
METHODS	The effect of the interventions was evaluated by assessing the Visual Analogue Scale ( VAS ) , Japanese Orthopedic Association Scores ( JOA ) , WHO Quality of Life-BREF ( WHOQOL-BREF ) , length of hospital stay and adverse event .
RESULTS	All the 120 patients were followed up and analyzed .
RESULTS	Significant differences were found between the treatment and control groups in VAS , JOA Scores , and WHOQOL-BREF ( P < 0.01 ) at 2 , 4 , and 8 week and at 6 and 12 months after the surgery .
RESULTS	At 6 and 12 months postoperatively , the JOA Scores ( P < 0.01 ) , but not the VAS and WHOQOL-BREF , differed significantly between the two groups .
CONCLUSIONS	Blood-activating and kidney-nourishing therapy is effective in promoting postoperative recovery and helps reduce the clinical symptoms and minimize the adverse events in patients undergoing surgery for lumber intervertebral disc herniation .

###24424781
BACKGROUND	Pharmacological stimulation of D2 receptors modulates prefrontal neural activity associated with working memory ( WM ) processing .
BACKGROUND	The T allele of a functional single-nucleotide polymorphism ( SNP ) within DRD2 ( rs1076560 G > T ) predicts reduced relative expression of the D2S receptor isoform and less efficient neural cortical responses during WM tasks .
OBJECTIVE	We used functional MRI to test the hypothesis that DRD2 rs1076560 genotype interacts with pharmacological stimulation of D2 receptors with bromocriptine on prefrontal responses during different loads of a spatial WM task ( N-Back ) .
METHODS	Fifty-three healthy subjects ( 38 GG and 15 GT ) underwent two 3-T functional MRI scans while performing the 1 - , 2 - and 3-Back versions of the N-Back WM task .
METHODS	Before the imaging sessions , either bromocriptine or placebo was administered to all subjects in a counterbalanced order .
METHODS	A factorial repeated-measures ANOVA within SPM8 ( p < 0.05 , family-wise error corrected ) was used .
RESULTS	On bromocriptine , GG subjects had reduced prefrontal activity at 3-Back together with a significant decrement in performance , compared with placebo .
RESULTS	On the other hand , GT subjects had lower activity for the same level of performance at 1-Back but a trend for reduced behavioral performance in the face of unchanged activity at 2-Back .
CONCLUSIONS	These results indicate that bromocriptine stimulation modulates prefrontal activity in terms of disengagement or of efficiency depending on DRD2 genotype and working memory load .

###24745347
BACKGROUND	Bibersteinia trehalosi causes respiratory disease in ruminants particularly in wild and domestic sheep .
BACKGROUND	Recently , there has been an increased number of B. trehalosi isolates obtained from diagnostic samples from bovine respiratory disease cases .
BACKGROUND	This study evaluated the role of B. trehalosi in bovine respiratory disease using an intra-tracheal inoculation model in calves .
BACKGROUND	Thirty six cross bred 2-3 month old dairy calves were inoculated intra-tracheally with either leukotoxin negative B. trehalosi , leukotoxin positive B. trehalosi isolate , Mannheimia haemolytica , a combination of leukotoxin negative B. trehalosi and M. haemolytica or negative control .
BACKGROUND	Calves were euthanized and necropsy performed on day 10 of study .
RESULTS	B. trehalosi inoculated calves did not have increased lung involvement compared to control calves .
RESULTS	Additionally , B. trehalosi was only cultured once from the lungs of inoculated calves at necropsy .
CONCLUSIONS	Based on these findings B. trehalosi may not be a primary pathogen of respiratory disease in cattle .
CONCLUSIONS	Culture of B. trehalosi from diagnostic submissions should not be immediately identified as a primary cause of respiratory disease .

###24395069
OBJECTIVE	This study was intended to evaluate the efficacy of fibrin glue ( FG ) in preventing post-traumatic focal pancreatitis ( PTFP ) after radical gastrectomy by examining the drainage fluids over 7 days post-op .
METHODS	Ninety-five patients who underwent D2 radical gastrectomy for gastric cancer were randomly assigned to a fibrin glue group ( n = 48 ) receiving fibrin glue on the raw surface of the pancreas during surgery and a control group ( n = 47 ) , which did not receive fibrin glue .
RESULTS	We found no significant difference in operation time and intraoperative blood loss between groups ( p > 0.05 ) ; no deaths occurred during surgery .
RESULTS	The volume of ascitic fluid containing blood cells in the fibrin glue group was significantly lower than that in the control group ( p < 0.001 ) at all times observed .
RESULTS	Amylase levels in the drained fluids were highest at 24 h postoperatively in both groups , suggesting pancreatitis , but gradually decreased to normal levels within 7 days .
RESULTS	The amylase in the drains in the control group was significantly higher than that in the FG group ( p < 0.001 ) at all times observed , but it returned to normal 72 h postoperatively in the FG group .
RESULTS	One death by hemorrhagic shock associated with PTFP was recorded in the control group .
CONCLUSIONS	Fibrin glue is safe and effective in preventing PTFP following gastric surgery and shortens the clinical course of the disease .

###24881210
OBJECTIVE	This study aimed to investigate the duration of gingival healing after the stage II surgery of dental implantation for periodontitis patients and to provide clinical guidelines for implant restoration .
METHODS	Twenty-nine periodontitis patients who had implantation surgery and achieved osseointegration were operated with stage II surgery ( a total of 60 pieces of implants ) .
METHODS	The height of buccal gingival of each implant was measured twice after the stage II surgery .
METHODS	All implants were measured at the lowest point ofbuccal gingival after one week .
METHODS	The implants were randomly divided into four groups according to the schedule of the next test time : group one at one week from the initial test point , group two at two weeks , group three at three weeks , and group four at four weeks .
METHODS	Each group includes 15 pieces of implants .
METHODS	The amount of the buccal gingival change in each group between the second and first tests was determined , and the data were analyzed statistically .
RESULTS	The amount of gingival change of groups one , two , three , and four was ( -0.25 + / - 0.66 ) , ( -0.04 + / - 0.52 ) , ( -0.70 + / - 0.77 ) , and ( -0.74 + / - 1.09 ) mm , respectively .
RESULTS	No significant difference was observed between groups one and two in terms of the amount of gingival changes ( P > 0.05 ) .
RESULTS	However , a significant difference was found between groups two and three ( P < 0.05 ) , and the amount of gingival recession was 0.66 mm .
RESULTS	No significant difference was found between groups three and four ( P > 0.05 ) , and the gingival achieved stability .
CONCLUSIONS	The gingival recession achieves stability at the fourth week ( after 28 d ) after stage II surgery .
CONCLUSIONS	At this time , the implant can be restored , and the abutment can be selected according to the amount of gingival change of the periodontitis patient .

###24411805
OBJECTIVE	Previous research has identified several aspects of behavioral undercontrol that are associated with heavy drinking and problems .
OBJECTIVE	Further , research on the acquired preparedness model ( Smith and Anderson , 2001 ) has identified biased learning as a potential mechanism of these effects .
OBJECTIVE	Traits like sensation seeking have been linked to stronger positive and weaker negative expectancies , which , in turn , contribute to increased risk for heavy drinking and problems .
OBJECTIVE	Although expectancies are thought to represent potentially biased expectations about drinking outcomes , they may also reflect individual differences in alcohol response .
OBJECTIVE	The present study examined the strength of associations between sensation seeking and both expectancies ( response to placebo ) and subjective response under alcohol .
METHODS	Using a between-subjects design , young adult social drinkers ( N = 236 ) were randomly assigned to receive alcohol ( target breath alcohol concentration of .08 % ) or placebo , after which they reported on subjective experiences of stimulation and sedation .
RESULTS	Sensation seeking was significantly related to stimulant response , and the strength of this association did not differ by beverage condition ( alcohol vs. placebo ) .
CONCLUSIONS	The findings argue against a pharmacological explanation for results of prior studies of the acquired preparedness model and support a biased learning interpretation of relations between sensation seeking and positive expectancies .
CONCLUSIONS	Results also extend the findings on the acquired preparedness model to an implicit measure of positive alcohol expectancies ( subjective response to placebo ) .
CONCLUSIONS	Future studies using additional measures of implicit expectancies ( e.g. , Implicit Association Test ) would be helpful in determining the relative strength of implicit and explicit expectancies as mediators within the acquired preparedness model .

###25837356
OBJECTIVE	To prospectively evaluate the efficacy of Removing Stasis and Reducing Heat Formula in accelerating calculus clearance and improving lower urinary tract symptoms of patients with proximal ureteral calculi after ureteroscopic Ho : YAG laser lithotripsy .
METHODS	A total of 138 patients with proximal ureteral calculi underwent ureteroscopic Ho : YAG laser lithotripsy by a single endocrinologist .
METHODS	Stone size varied from 10 to 15 mm .
METHODS	After operation , the patients were randomly divided into three groups : the control group ( group A ) , tamsulosin group ( group B ) , and Removing Stasis and Reducing Heat Formula group ( group C ) .
METHODS	The treatment lasted for 4 weeks or until stone clearance .
METHODS	The primary and secondary outcomes of the three groups at follow-up were assessed .
RESULTS	Of the 131 patients available for follow-up , 44 cases were in the group A , 45 in the group B , and 42 in the group C , respectively .
RESULTS	The stone free rate at 2 weeks in the groups B and C were significantly higher than that in the group A ( 95.56 % , 97.62 % vs. 79.55 % ; all P < 0.05 ) .
RESULTS	The ureteral colic rate and mean time of fragment expulsion were significantly reduced in the groups B ( 4.44 % and 7.864.99 days ) and C ( 2.43 % and 6.764.37 days ) compared with the group A ( 22.73 % and 11.549.89 days , all P < 0.05 ) .
RESULTS	On the day of double-J ureteric stent removal , the group C differed significantly from the group A in the total International Prostate Symptom Score , irritative subscore , obstructive subscore , and quality of life score ( all P < 0.05 ) .
CONCLUSIONS	Removing Stasis and Reducing Heat Formula in the medical expulsive therapy might be an effective modality for patients with calculus in the proximal uretera after ureteroscopic Ho : YAG laser lithotripsy .

###25421802
OBJECTIVE	High-fidelity patient simulation ( HFPS ) has been used in medical education to bridge gaps in medical knowledge and clinical skills .
OBJECTIVE	Few studies have analyzed the impact of HFPS in subspecialty rotations for pediatric residents .
OBJECTIVE	We hypothesized that pediatric residents exposed to HFPS with a structured content curriculum would perform better on a case quiz than residents without exposure to HFPS .
METHODS	Prospective randomized controlled
METHODS	Tertiary-care free standing children 's hospital
METHODS	During a cardiology rotation , senior pediatric residents completed an online pediatric cardiology curriculum and a cardiology quiz .
METHODS	After randomization into two groups , the study group participated in a fully debriefed HFPS session .
METHODS	The control group had no HFPS .
METHODS	Both groups completed a case quiz .
METHODS	Confidence surveys pre - and postsimulation were completed .
RESULTS	From October 2010 through March 2013 , 55 residents who rotated through the pediatric cardiology rotation were used in the final analysis ( 30 control , 25 in the study group ) .
RESULTS	There was no significant difference between groups on the initial cardiology quiz .
RESULTS	The study group scored higher on the case quiz compared with the control group ( P = .024 ) .
RESULTS	Based on pre - and postsimulation questionnaires , residents ' confidence in approaching a pediatric cardiology patient improved from an average Likert score of 5.1 to 7.5 ( on scale of 0-10 ) ( P < .001 ) .
CONCLUSIONS	Incorporation of HFPS into a preexisting pediatric cardiology rotation was feasible and well received .
CONCLUSIONS	Our study suggests that simulation promotes increased confidence and may modestly improve clinical reasoning compared to traditional educational techniques .
CONCLUSIONS	Targeted simulation sessions may readily be incorporated into pediatric subspecialty rotations .

###24670774
OBJECTIVE	To assess whether immediate ( 0h ) , intermediate ( after 6h ) or delayed ( after 24h ) removal of an indwelling urinary catheter after uncomplicated abdominal hysterectomy can affect the rate of re-catheterization due to urinary retention , rate of urinary tract infection , ambulation time and length of hospital stay .
METHODS	Prospective randomized controlled trial conducted at Suez Canal University Hospital , Egypt .
METHODS	Two hundred and twenty-one women underwent total abdominal hysterectomy for benign gynecological diseases and were randomly allocated into three groups .
METHODS	Women in group A ( 73 patients ) had their urinary catheter removed immediately after surgery .
METHODS	Group B ( 81 patients ) had the catheter removed 6h post-operatively while in group C ( 67 patients ) the catheter was removed after 24h .
METHODS	The main outcome measures were the frequency of urinary retention , urinary tract infections , ambulation time and length of hospital stay .
RESULTS	There was a significantly higher number of urinary retention episodes requiring re-catheterization in the immediate removal group compared to the intermediate and delayed removal groups ( 16.4 % versus 2.5 % and 0 % respectively ) .
RESULTS	Delayed urinary catheter removal was associated with a higher incidence of urinary tract infections ( 15 % ) , delayed ambulation time ( 10.3 h ) and longer hospital stay ( 5.6 days ) compared to the early ( 1.4 % , 4.1 h and 3.2 days respectively ) and intermediate ( 3.7 % , 6.8 h and 3.4 days respectively ) removal groups .
CONCLUSIONS	Removal of the urinary catheter 6h postoperatively appears to be more advantageous than early or late removal in cases of uncomplicated total abdominal hysterectomy .

###25139479
BACKGROUND	Transvaginal cholecystectomy ( TVC ) is regarded as a model operation in the newly developed field of natural orifice transluminal endoscopic surgery ( NOTES ) .
BACKGROUND	Randomized , controlled trials to assess TVC as a surgical strategy are largely missing .
METHODS	The study was a double blind , randomized , controlled , single center trial in female patients > 18 years with symptomatic cholecystolithiasis comparing laparoscopic cholecystectomy ( CLC ) and TVC .
METHODS	The study investigated pain reduction of 1 point on a visual-numeric rating scale with a follow-up after 7 days .
METHODS	Secondary endpoints were complications and patient reported outcome .
METHODS	Groups were established using computer-generated randomization and sealed envelopes in the operating theatre .
METHODS	At the end of the surgical procedure all patients received a standard 4-trocar dressing as for CLC and a vaginal tamponade .
RESULTS	A total of 426 patients were asked to participate , of which 97 were randomized , 51 in the CLC , 41 in the TVC groups and 5 were excluded from the study .
RESULTS	Patients were comparable regarding age , body mass index ( BMI ) and American Society of Anesthesiologists ( ASA ) grade .
RESULTS	Surgical and anesthesia times were significantly different .
RESULTS	There was no difference in postoperative pain .
RESULTS	The majority of patients were satisfied with both procedures and TVC was recommended to other patients by 93 % of patients in the TVC group .
CONCLUSIONS	The results did not show superiority of TVC over CLC with regards to postoperative pain .
CONCLUSIONS	With no differences in postoperative pain and high patient satisfaction , TVC can be recommended to future patients as an alternative method .
CONCLUSIONS	For confirmation of this evaluation of TVC further randomized trials are needed .

###24704658
BACKGROUND	It has been previously demonstrated that listening to 1/f sound effectively reduces stress .
BACKGROUND	However , these findings have been inconsistent and further study on the relationship between 1/f sound and the stress response is consequently necessary .
OBJECTIVE	The present study examined whether sound with 1/f properties ( 1/f sound ) affects stress-induced electroencephalogram ( EEG ) changes .
METHODS	Twenty-six subjects who voluntarily participated in the study were randomly assigned to the experimental or control group .
METHODS	Data from four participants were excluded because of EEG artifacts .
METHODS	A mental arithmetic task was used as a stressor .
METHODS	Participants in the experiment group listened to 1/f sound for 5 minutes and 33 seconds , while participants in the control group sat quietly for the same duration .
METHODS	EEG recordings were obtained at various points throughout the experiment .
METHODS	After the experiment , participants completed a questionnaire on the affective impact of the 1/f sound .
RESULTS	The results indicated that the mental arithmetic task effectively induced a stress response measurable by EEG .
RESULTS	Relative theta power at all electrode sites was significantly lower than baseline in both the control and experimental group .
RESULTS	Relative alpha power was significantly lower , and relative beta power was significantly higher in the T3 and T4 areas .
RESULTS	Secondly , 1/f sound and simple resting affected task-associated EEG changes in a similar manner .
RESULTS	Finally , participants reported in the questionnaire that they experienced a positive feeling in response to the 1/f sound .
CONCLUSIONS	Our results suggest that a commercialized 1/f sound product is not more effective than simple resting in alleviating the physiological stress response .

###25158895
OBJECTIVE	We aimed to examine the effect of high-fat diet ( HFD ) on prostate cancer ( PCa ) development and progression and to investigate whether metformin would postpone PCa development and progression promoted by HFD .
METHODS	TRAMP mice were randomly divided into three groups : normal diet group , HFD group and metformin-HFD ( Met-HFD ) group .
METHODS	Mortality rate and tumor formation rate were examined .
METHODS	TRAMP mice were sacrificed and sampled on the 20th , 24 ( th ) , and 28th week , respectively .
METHODS	Serum levels of insulin and IGF-1 were tested by ELISA .
METHODS	Prostate tissue of TRAMP mice was used for HE staining .
RESULTS	A total of 17 deaths of TRAMP mice were observed , including 3 ( 10 % ) from the normal diet group , 10 ( 33.33 % ) from the HFD group , and 4 ( 13.33 % ) from Met-HFD group .
RESULTS	The mortality rate of TRAMP mice from HFD group was significantly higher than that of normal diet group ( P = 0.028 ) , and metformin could moderately decrease the mortality rate by 60.01 % ( P = 0.067 ) .
RESULTS	Tumor formation rates were not significantly different among the three groups .
RESULTS	Levels of glucose , insulin , and IGF-1 tended to increase with TRAMP mice 's age in HFD group .
RESULTS	TRAMP mice from HFD group had higher serum insulin and IGF-1 levels .
RESULTS	A moderate decrease in IGF-1 was also seen in Met-HFD group .
CONCLUSIONS	HFD could promote TRAMP mouse PCa development and progression and metformin had moderate effect of reducing PCa mortality rate with a decrease in serum IGF-1 level .

###24633018
OBJECTIVE	Worldwide , sentinel node biopsy ( SNB ) is now a standard staging procedure for most patients with melanomas 1 mm or more in thickness , but its therapeutic benefit is not clear , pending randomized trial results .
OBJECTIVE	This study sought to assess the therapeutic benefit of SNB in a large , nonrandomized patient cohort .
METHODS	Patients with primary melanomas 1.00 mm or more thick or with adverse prognostic features treated with wide local excision ( WLE ) at a single institution between 1992 and 2008 were identified .
METHODS	The outcomes for those who underwent WLE plus SNB ( n = 2909 ) were compared with the outcomes for patients in an observation ( OBS ) group who had WLE only ( n = 2931 ) .
METHODS	Median follow-up was 42 months .
RESULTS	Melanoma-specific survival ( MSS ) was not significantly different for patients in the SNB and OBS groups .
RESULTS	However , a stratified univariate analysis of MSS for different thickness subgroups indicated a significantly better MSS for SNB patients with T2 and T3 melanomas ( > 1.0 to 4.0 mm thick ) ( P = 0.011 ) , but this was not independently significant in multivariate analysis .
RESULTS	Compared with OBS patients , SNB patients demonstrated improved disease-free survival ( DFS ) ( P < 0.001 ) and regional recurrence-free survival ( P < 0.001 ) .
RESULTS	There was also an improvement in distant metastasis-free survival ( DMFS ) for SNB patients with T2 and T3 melanomas ( P = 0.041 ) .
CONCLUSIONS	In this study , the outcome for the overall cohort after WLE alone did not differ significantly from the outcome after additional SNB .
CONCLUSIONS	However , the outcome for the subgroup of patients with melanomas more than 1.0 to 4.0 mm in thickness was improved if they had a SNB , with significantly improved disease-free and DMFS .

###25091463
BACKGROUND	The trapeziometacarpal ( TMC ) joint of the human thumb is the second most common joint in the hand affected by osteoarthritis .
BACKGROUND	TMC arthroplasty is a common procedure used to alleviate symptoms .
BACKGROUND	No randomized controlled trials have been published on the efficacy of different post-operative orthotic regimes .
METHODS	Fifty six participants who underwent TMC arthroplasty were allocated to either rigid orthotic or semi-rigid orthotic groups .
METHODS	Both groups started an identical exercise program at two weeks following surgery .
METHODS	Outcome measures were assessed by an assessor blinded to group allocation .
METHODS	The primary outcome was the Patient Rated Wrist and Hand Evaluation ( PRWHE ) and secondary outcomes included the Michigan Hand Questionnaire ( MHQ ) , thumb palmar abduction , first metacarpophalangeal extension and three point pinch grip .
METHODS	Measures were taken pre-operatively , at six weeks , three months and one year post-operatively .
METHODS	Between-group differences were analyzed with linear regression .
RESULTS	Both groups performed equally well .
RESULTS	There was no significant between-group difference for PRWHE scores ( 0.47 , CI -11.5 to 12.4 ) , including subscales for pain and function , or for any of the secondary outcomes at one year follow-up .
CONCLUSIONS	We found no difference in outcomes between using a rigid or semi-rigid orthosis after TMC arthroplasty .
CONCLUSIONS	Patient comfort , cost and availability may determine choice between orthoses in clinical practice .
METHODS	1b RCT .

###24490608
OBJECTIVE	The aim of this article was to evaluate afatinib ( BIBW 2992 ) , an ErbB family blocker , and nintedanib ( BIBF 1120 ) , a triple angiokinase inhibitor , in castration-resistant prostate cancer patients .
METHODS	Patients were randomized to receive nintedanib ( 250 mg twice daily ) , afatinib ( 40 mg once daily [ q.d. ] ) , or alternating sequential 7-day nintedanib ( 250 mg twice daily ) and afatinib ( 70 mg q.d. [ Combi70 ] ) , which was reduced to 40 mg q.d. ( Combi40 ) due to adverse events .
METHODS	The primary end point was progression-free rate at 12 weeks .
RESULTS	Of the 85 patients treated 46 , 20 , 16 and three received nintedanib , afatinib , Combi40 and Combi70 , respectively .
RESULTS	At 12 weeks , the progression-free rate was 26 % ( seven out of 27 patients ) for nintedanib , and 0 % for afatinib and Combi40 groups .
RESULTS	Two patients had a 50 % decline in PSA ( nintedanib and the Combi40 groups ) .
RESULTS	The most common drug-related adverse events were diarrhea , nausea , vomiting and lethargy .
CONCLUSIONS	Nintedanib and/or afatinib demonstrated limited anti-tumor activity in unselected advanced castration-resistant prostate cancer patients .

###24769888
BACKGROUND	Bone marrow stem cell ( BMSC ) therapy for cardiovascular disease has shown considerable preclinical and clinical promise , but there remains a need for mechanistic studies to help bridge the transition from bench to bedside .
BACKGROUND	We have designed a substudy to our REGENERATE-IHD trial ( ClinicalTrial.gov Identifier : NCT00747708 ) to assess the feasibility of a novel imaging technique to detect angiogenesis following BMSC therapy .
RESULTS	Nine patients who had been randomized to receive intracoronary injection of G-CSF-mobilized BMSCs or control ( serum ) were included in this substudy .
RESULTS	Patients underwent SPECT imaging using a novel radiolabelled peptide ( Tc-NC100692 ) , which has a high affinity for the v3 integrin , an angiogenesis-related integrin .
RESULTS	This was repeated 4 days after intracoronary injection of BMSCs/control to assess for neoangiogenesis .
RESULTS	The imaging study was well tolerated with no adverse effects .
RESULTS	Myocardial tracer uptake was detectable at baseline in all nine patients , with no myocardial uptake seen in two control patients used for comparison .
RESULTS	Baseline uptake appeared to correlate with baseline ejection fraction but changes with therapy did not reach statistical significance .
CONCLUSIONS	SPECT imaging with a Tc-NC100692 is feasible in patients with heart failure , with baseline activity suggesting persistent angiogenesis in patients with remote myocardial infarction .

###24983433
OBJECTIVE	To compare long-term health outcome of Sanders type IV calcaneal fractures treated with open reduction and internal fixation ( ORIF ) versus ORIF plus primary subtalar arthrodesis ( PSTA ) .
METHODS	Randomized prospective multicenter trial .
METHODS	Four Level 1 trauma hospitals in Canada .
METHODS	Thirty-one patients with 31 Sanders IV displaced intraarticular calcaneal fractures .
METHODS	Seventeen patients were treated with a standard protocol involving a lateral approach for ORIF .
METHODS	Fourteen patients were treated with a standard protocol involving a lateral approach with ORIF + PSTA .
METHODS	Health outcomes were assessed with 4 validated instruments : ( 1 ) the Short Form 36 version 2 ( SF-36 ) , ( 2 ) the Musculoskeletal Functional Assessment Survey , ( 3 ) the American Orthopaedic Foot and Ankle Society 's Ankle-Hindfoot Scale , and ( 4 ) the Visual Analogue Scale .
RESULTS	From 2004 to 2011 , 26 patients ( 26 displaced intraarticular calcaneal fractures ) were followed for a minimum of 2 years ( 81 % follow-up ) .
RESULTS	No statistical difference was found between the results for ORIF compared with ORIF + PSTA : the mean SF-36 physical component scores were , respectively , 30.2 ( SD = 11.4 ) and 37.8 ( SD = 10.4 ) ( P = 0.10 ) ; the mean Musculoskeletal Functional Assessment Survey scores were 44.2 ( SD = 25.6 ) and 37.9 ( SD = 21.5 ) ( P = 0.50 ) ; the mean Ankle-Hindfoot Scale scores were 62.5 ( SD = 19.6 ) and 65.8 ( SD = 19.2 ) , ( P = 0.68 ) ; and the mean Visual Analogue Scale scores were 36.8 ( SD = 34.7 ) and 36.0 ( SD = 30.7 ) ( P = 0.82 ) .
CONCLUSIONS	We were unable to demonstrate a significant difference between treating Sanders type IV fractures with either ORIF or ORIF + PSTA .
CONCLUSIONS	It remains the choice of the surgeon and patient to take into account patient specific factors to determine treatment .
CONCLUSIONS	However , ORIF + PSTA may be advantageous for both patients with Sanders type IV fractures and the health care system as patients heal quickly .
CONCLUSIONS	Furthermore , ORIF + PSTA may prevent the need for late secondary subtalar fusion adding to increased costs and lost time from work .
METHODS	Therapeutic Level II .
METHODS	See Instructions for Authors for a complete description of levels of evidence .

###25514303
OBJECTIVE	Foods that have similar carbohydrate content can differ in the amount they raise blood glucose .
OBJECTIVE	The effects of this property , called the glycemic index , on risk factors for cardiovascular disease and diabetes are not well understood .
OBJECTIVE	To determine the effect of glycemic index and amount of total dietary carbohydrate on risk factors for cardiovascular disease and diabetes .
METHODS	Randomized crossover-controlled feeding trial conducted in research units in academic medical centers , in which 163 overweight adults ( systolic blood pressure , 120-159 mm Hg ) were given 4 complete diets that contained all of their meals , snacks , and calorie-containing beverages , each for 5 weeks , and completed at least 2 study diets .
METHODS	The first participant was enrolled April 1 , 2008 ; the last participant finished December 22 , 2010 .
METHODS	For any pair of the 4 diets , there were 135 to 150 participants contributing at least 1 primary outcome measure .
METHODS	( 1 ) A high-glycemic index ( 65 % on the glucose scale ) , high-carbohydrate diet ( 58 % energy ) ; ( 2 ) a low-glycemic index ( 40 % ) , high-carbohydrate diet ; ( 3 ) a high-glycemic index , low-carbohydrate diet ( 40 % energy ) ; and ( 4 ) a low-glycemic index , low-carbohydrate diet .
METHODS	Each diet was based on a healthful DASH-type diet .
METHODS	The 5 primary outcomes were insulin sensitivity , determined from the areas under the curves of glucose and insulin levels during an oral glucose tolerance test ; levels of low-density lipoprotein ( LDL ) cholesterol , high-density lipoprotein ( HDL ) cholesterol , and triglycerides ; and systolic blood pressure .
RESULTS	At high dietary carbohydrate content , the low - compared with high-glycemic index level decreased insulin sensitivity from 8.9 to 7.1 units ( -20 % , P = .002 ) ; increased LDL cholesterol from 139 to 147 mg/dL ( 6 % , P. 001 ) ; and did not affect levels of HDL cholesterol , triglycerides , or blood pressure .
RESULTS	At low carbohydrate content , the low - compared with high-glycemic index level did not affect the outcomes except for decreasing triglycerides from 91 to 86 mg/dL ( -5 % , P = .02 ) .
RESULTS	In the primary diet contrast , the low-glycemic index , low-carbohydrate diet , compared with the high-glycemic index , high-carbohydrate diet , did not affect insulin sensitivity , systolic blood pressure , LDL cholesterol , or HDL cholesterol but did lower triglycerides from 111 to 86 mg/dL ( -23 % , P. 001 ) .
CONCLUSIONS	In this 5-week controlled feeding study , diets with low glycemic index of dietary carbohydrate , compared with high glycemic index of dietary carbohydrate , did not result in improvements in insulin sensitivity , lipid levels , or systolic blood pressure .
CONCLUSIONS	In the context of an overall DASH-type diet , using glycemic index to select specific foods may not improve cardiovascular risk factors or insulin resistance .
BACKGROUND	clinicaltrials.gov Identifier : NCT00608049 .

###25733749
OBJECTIVE	Early interventions for toddlers with expressive and receptive language delays have not resulted in positive expressive language outcomes .
OBJECTIVE	This randomized controlled trial tested the effects on language outcomes of a caregiver-implemented communication intervention targeting toddlers at risk for persistent language delays .
METHODS	Participants included 97 toddlers , who were between 24 and 42 months with language scores at least 1.33 SDs below the normative mean and no other developmental delays , and their caregivers .
METHODS	Toddlers were randomly assigned to the caregiver-implemented intervention or a usual-care control group .
METHODS	Caregivers and children participated in 28 sessions in which caregivers were taught to implement the intervention .
METHODS	The primary outcome was the Preschool Language Scale , Fourth Edition , a broad-based measure of language .
METHODS	Outcome measurement was not blinded .
RESULTS	Caregivers in the intervention improved their use of all language facilitation strategies , such as matched turns ( adjusted mean difference , intervention-control , 40 ; 95 % confidence interval 34 to 46 ; P < .01 ) .
RESULTS	Children in the intervention group had significantly better receptive language skills ( 5.3 ; 95 % confidence interval 0.15 to 10.4 ) , but not broad-based expressive language skills ( 0.37 , 95 % confidence interval -4.5 to 5.3 ; P = .88 ) .
CONCLUSIONS	This trial provides preliminary evidence of the short-term effects of systematic caregiver instruction on caregiver use of language facilitation strategies and subsequent changes in children 's language skills .
CONCLUSIONS	Future research should investigate the ideal dosage levels for optimizing child outcomes and determine which language facilitation strategies are associated with specific child outcomes .
CONCLUSIONS	Research on adaptations for families from culturally and linguistically diverse backgrounds is needed .

###24909499
BACKGROUND	New antibiotics are needed to treat infections caused by drug-resistant bacteria .
BACKGROUND	Tedizolid is a novel oxazolidinone antibacterial drug designed to provide enhanced activity against Gram-positive pathogens .
BACKGROUND	We aimed to assess the efficacy and safety of intravenous to oral tedizolid for treatment of patients with acute bacterial skin and skin-structure infections .
METHODS	ESTABLISH-2 was a randomised , double-blind , phase 3 , non-inferiority trial done between Sept 28 , 2011 , and Jan 10 , 2013 , at 58 centres in nine countries .
METHODS	Patients ( aged 12 years ) with acute bacterial skin and skin-structure infections ( cellulitis or erysipelas , major cutaneous abscess , or wound infection ) that had a minimum lesion area of 75 cm ( 2 ) and were suspected or documented to be associated with a Gram-positive pathogen , were randomly assigned ( 1:1 ) , via an interactive voice-response system with block randomisation , to receive intravenous once-daily tedizolid ( 200 mg for 6 days ) or twice-daily linezolid ( 600 mg for 10 days ) , with optional oral step-down .
METHODS	Randomisation was stratified by geographic region and type of acute bacterial skin and skin-structure infection .
METHODS	The primary endpoint was early clinical response ( 20 % reduction in lesion area at 48-72 h compared with baseline ) , with a non-inferiority margin of -10 % .
METHODS	Analysis was by intention to treat .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01421511 .
RESULTS	666 patients were randomly assigned to receive tedizolid ( n = 332 ) or linezolid ( n = 334 ) .
RESULTS	283 ( 85 % ) patients in the tedizolid group and 276 ( 83 % ) in the linezolid group achieved early clinical response ( difference 26 % , 95 % CI -30 to 82 ) , meeting the prespecified non-inferiority margin .
RESULTS	Gastrointestinal adverse events were less frequent with tedizolid than linezolid , taking place in 52 ( 16 % ) of 331 patients and 67 ( 20 % ) of 327 patients in the safety population .
RESULTS	Treatment-emergent adverse events leading to discontinuation of study drug were reported by one ( < 1 % ) patient in the tedizolid group and four ( 1 % ) patients in the linezolid group .
CONCLUSIONS	Intravenous to oral once-daily tedizolid 200 mg for 6 days was non-inferior to twice-daily linezolid 600 mg for 10 days for treatment of patients with acute bacterial skin and skin-structure infections .
CONCLUSIONS	Tedizolid could become a useful option for the treatment of acute bacterial skin and skin-structure infections in the hospital and outpatient settings .
BACKGROUND	Cubist Pharmaceuticals .

###25791668
OBJECTIVE	Epidemiological evidence suggests an association between psychological factors and functional dyspepsia ( FD ) .
OBJECTIVE	Yet few randomized controlled trials ( RCTs ) of psychological interventions have been conducted for FD .
OBJECTIVE	We conducted an RCT to evaluate the efficacy of psychotherapy among chronic FD .
METHODS	One hundred fifty-eight consecutive patients with FD were randomized to medical therapy plus psychotherapy consisted in 8 group and 2 individual sessions focused on teaching techniques for coping with FD ( intensive treatment ( IT ) ; n = 76 ) or medical therapy alone ( conventional treatment ( CT ) ; n = 82 ) .
METHODS	Patients completed validated self-reported questionnaires before and after the 10-week treatment and 6 months later .
METHODS	Linear mixed-effects models were used , in intention-to-treat analysis .
RESULTS	At the end of treatment period , statistically significant improvements were observed for IT compared with CT for dyspepsia-related quality of life ( DRQoL ) .
RESULTS	DRQoL mean changes of 6.09 and 3.54 were obtained in IT and CT patients , respectively ( p = < 0.0001 ) ; and SS mean changes of 11.55 and 4.57 were obtained in IT and CT patients , respectively ( p = 0.0013 ) .
RESULTS	Those improvements , measured by minimum clinically important difference ( MCID ) , were clinically significant ( DRQoL : 77 % of the IT patients exceeded the MCID vs. the 45 % of the CT ; SS : 75 % vs. 48 % ) .
RESULTS	Six months after treatment , those statistically significant improvements persisted for DRQoL ( p = 0.0067 ) and for SS ( p = 0.0405 ) .
RESULTS	Clinical improvements persisted for SS ( 63 % vs. 41 % ) .
CONCLUSIONS	These findings suggest that adding psychotherapy to standard medical therapy improves short-term outcomes in patients with FD and may have long-term effects as well .
CONCLUSIONS	The cost-effectiveness of intensive therapy needs to be evaluated .
CONCLUSIONS	Registration number and name of trial registry : NCT01802710 .

###26033801
OBJECTIVE	EURAMOS-1 , an international randomized controlled trial , investigated maintenance therapy with pegylated interferon alfa-2b ( IFN -- 2b ) in patients whose osteosarcoma showed good histologic response ( good response ) to induction chemotherapy .
METHODS	At diagnosis , patients age 40 years with resectable high-grade osteosarcoma were registered .
METHODS	Eligibility after surgery for good response random assignment included two cycles of preoperative MAP ( methotrexate , doxorubicin , and cisplatin ) , macroscopically complete surgery of primary tumor , < 10 % viable tumor , and no disease progression .
METHODS	These patients were randomly assigned to four additional cycles MAP with or without IFN -- 2b ( 0.5 to 1.0 g/kg per week subcutaneously , after chemotherapy until 2 years postregistration ) .
METHODS	Outcome measures were event-free survival ( EFS ; primary ) and overall survival and toxicity ( secondary ) .
RESULTS	Good response was reported in 1,041 of 2,260 registered patients ; 716 consented to random assignment ( MAP , n = 359 ; MAP plus IFN -- 2b , n = 357 ) , with baseline characteristics balanced by arm .
RESULTS	A total of 271 of 357 started IFN -- 2b ; 105 stopped early , and 38 continued to receive treatment at data freeze .
RESULTS	Refusal and toxicity were the main reasons for never starting IFN -- 2b and for stopping prematurely , respectively .
RESULTS	Median IFN -- 2b duration , if started , was 67 weeks .
RESULTS	A total of 133 of 268 patients who started IFN -- 2b and provided toxicity information reported grade 3 toxicity during IFN -- 2b treatment .
RESULTS	With median follow-up of 44 months , 3-year EFS for all 716 randomly assigned patients was 76 % ( 95 % CI , 72 % to 79 % ) ; 174 EFS events were reported ( MAP , n = 93 ; MAP plus IFN -- 2b , n = 81 ) .
RESULTS	Hazard ratio was 0.83 ( 95 % CI , 0.61 to 1.12 ; P = .214 ) from an adjusted Cox model .
CONCLUSIONS	At the preplanned analysis time , MAP plus IFN -- 2b was not statistically different from MAP alone .
CONCLUSIONS	A considerable proportion of patients never started IFN -- 2b or stopped prematurely .
CONCLUSIONS	Long-term follow-up for events and survival continues .

###25056464
OBJECTIVE	To evaluate differences in uteroplacental blood flow and pregnancy outcome in women with idiopathic recurrent spontaneous miscarriage ( IRSM ) following administration of micronized vaginal progesterone and oral dydrogesterone .
METHODS	One hundred and thirty-three women ( aged 23-40 years ) who had had early miscarriages and spontaneous conception participated .
METHODS	Oral dydrogesterone ( group A , n = 51 ) and micronized vaginal progesterone ( group B , n = 50 ) were administrated for luteal support and compared .
METHODS	Pregnant women without history of recurrent miscarriage served as controls ( group C , n = 32 ) .
METHODS	The outcome measures consisted of endometrial blood flow parameters by Doppler indices and ongoing pregnancy rate .
RESULTS	Before progesterone supplementation , resistivity index ( RI ) and pulsatility index ( PI ) were found to be significantly higher in groups A and B as compared to controls .
RESULTS	Although statistically not significant , end diastolic velocity ( EDV ) and systolic/diastolic ( S/D ) ratio was found to be superior in controls than IRSM women .
RESULTS	Peak systolic velocity ( PSV ) was comparable between IRSM and non-IRSM groups .
RESULTS	Following progesterone supplementation , groups A and B showed a highly significant reduction in RI , PI and an increase in EDV .
RESULTS	A relative increase in the value of PSV was observed in group A as compared to group B.
RESULTS	There was remarkable difference in S/D in both groups .
RESULTS	Although not statistically significant , group C showed reduction in RI , PI , PSV , EDV and S/D ratio .
RESULTS	Pregnancy salvage rates were higher in group A ( 92.0 % ) as compared to group B ( 82.3 % ) .
CONCLUSIONS	Progesterone supplementation appears to lower vascular resistance in women with IRSM .
CONCLUSIONS	Oral dydrogesterone appears to be equally effective in improving endometrial blood flow as compared with micronized progesterone .

###25162604
OBJECTIVE	To examine the relationship between the dose of fentanyl sublingual spray needed to control breakthrough cancer pain ( BTCP ) and the dose of around-the-clock ( ATC ) opioid used to control background pain .
METHODS	Analysis was based on the open-label , dose-titration phase ( up to 26 days ) of a randomized , double-blind , placebo-controlled trial .
METHODS	Opioid-tolerant cancer patients ( aged 18 years ) with chronic pain of moderate severity in the 24 hours before screening while receiving stable doses of scheduled ATC opioid therapy for 1 week and 1 to 4 episodes of BTCP per day .
METHODS	Fentanyl sublingual spray was initiated at 100 g. Dose titration proceeded until a dose was reached that provided adequate pain relief for two consecutive BTCP episodes without intolerable adverse effects ( AEs ) .
RESULTS	Overall , 98/130 ( 75.4 percent ) patients completed the dose-titration phase and achieved pain relief , and 73.5 percent of those who completed the titration period attained an effective dose of 600 g ( median effective dose , 800 g ) .
RESULTS	No clinically relevant correlation was found between effective doses of fentanyl sublingual spray for the treatment of BTCP and the ATC opioid doses used to control persistent pain ( Spearman rank correlation [ rs ] = 0.351 , n = 98 ) .
RESULTS	Sixty percent of patients reported 1 AE during the dose-titration phase .
RESULTS	The most common AEs considered related to study treatment were nausea ( 6.2 percent ) , somnolence ( 4.6 percent ) , dizziness ( 3.8 percent ) , and vomiting ( 3.8 percent ) .
CONCLUSIONS	These findings highlight the importance of titrating the dose of fentanyl sublingual spray to optimize dosing for individual patients .

###25603459
OBJECTIVE	The objective was to test the clinical utility of Quantose M ( Q ) to monitor changes in insulin sensitivity after pioglitazone therapy in prediabetic subjects .
OBJECTIVE	Quantose M ( Q ) is derived from fasting measurements of insulin , - hydroxybutyrate , linoleoyl-glycerophosphocholine , and oleate , three nonglucose metabolites shown to correlate with insulin-stimulated glucose disposal .
METHODS	Participants were 428 of the total of 602 ACT NOW impaired glucose tolerance ( IGT ) subjects randomized to pioglitazone ( 45 mg/d ) or placebo and followed for 2.4 years .
METHODS	At baseline and study end , fasting plasma metabolites required for determination of Quantose , glycated hemoglobin , and oral glucose tolerance test with frequent plasma insulin and glucose measurements to calculate the Matsuda index of insulin sensitivity were obtained .
RESULTS	Pioglitazone treatment lowered IGT conversion to diabetes ( hazard ratio = 0.25 ; 95 % confidence interval = 0.13-0 .50 ; P < .0001 ) .
RESULTS	Although glycated hemoglobin did not track with insulin sensitivity , Quantose M ( Q ) increased in pioglitazone-treated subjects ( by 1.45 [ 3.45 ] mgmin ( -1 ) kgwbm ( -1 ) ) ( median [ interquartile range ] ) ( P < .001 vs placebo ) , as did the Matsuda index ( by 3.05 [ 4.77 ] units ; P < .0001 ) .
RESULTS	Quantose M ( Q ) correlated with the Matsuda index at baseline and change in the Matsuda index from baseline ( rho , 0.85 and 0.79 , respectively ; P < .0001 ) and was progressively higher across closeout glucose tolerance status ( diabetes , IGT , normal glucose tolerance ) .
RESULTS	In logistic models including only anthropometric and fasting measurements , Quantose M ( Q ) outperformed both Matsuda and fasting insulin in predicting incident diabetes .
CONCLUSIONS	In IGT subjects , Quantose M ( Q ) parallels changes in insulin sensitivity and glucose tolerance with pioglitazone therapy .
CONCLUSIONS	Due to its strong correlation with improved insulin sensitivity and its ease of use , Quantose M ( Q ) may serve as a useful clinical test to identify and monitor therapy in insulin-resistant patients .

###25495747
BACKGROUND	Preterm-born or asphyxiated term-born children show more emotional and behavioral problems at preschool age than term-born children without a medical condition .
BACKGROUND	It is uncertain whether parenting intervention programs aimed at the general population , are effective in this specific group .
BACKGROUND	In earlier findings from the present trial , Primary Care Triple P was not effective in reducing parent-reported child behavioral problems .
BACKGROUND	However , parenting programs claim to positively change child behavior through enhancement of the parent-child interaction .
BACKGROUND	Therefore , we investigated whether Primary Care Triple P is effective in improving the quality of parent-child interaction and increasing the application of trained parenting skills in parents of preterm-born or asphyxiated term-born preschoolers with behavioral problems .
METHODS	For this pragmatic , open randomized clinical trial , participants were recruited from a cohort of infants admitted to the neonatal intensive care units of two Dutch hospitals .
METHODS	Children aged 2-5 years , with a gestational age < 32 weeks and/or birth weight < 1500 g and children with a gestational age 37-42 weeks and perinatal asphyxia were included .
METHODS	After screening for a t-score 60 on the Child Behavior Checklist , children were randomly assigned to Primary Care Triple P ( n = 34 ) or a wait-list control group ( n = 33 ) .
METHODS	Trial outcomes were the quality of parent-child interaction and the application of trained parenting skills , both scored from structured observation tasks .
RESULTS	There was no effect of the intervention on either of the observational outcome measures at the 6-month trial endpoint .
CONCLUSIONS	Primary Care Triple P , is not effective in improving the quality of parent-child interaction nor does it increase the application of trained parenting skills in parents of preterm-born or asphyxiated term-born children with behavioral problems .
CONCLUSIONS	Further research should focus on personalized care for these parents , with an emphasis on psychological support to reduce stress and promote self-regulation .
BACKGROUND	Netherlands National Trial Register NTR2179 .
BACKGROUND	Registered 26 January 2010 .

###25308231
BACKGROUND	Vitamin K1 ( VK1 ) reverses the effects of vitamin K antagonists ( VKAs ) .
BACKGROUND	The literature shows that the bioavailability from solutions might be higher than that from tablets , possibly resulting in different effects .
OBJECTIVE	To compare the bioavailability and effect on the International Normalized Ratio ( INR ) of 5-mg VK1 tablets and solution in three randomized clinical trials .
RESULTS	The bioavailability was determined in a crossover trial with 25 healthy volunteers .
RESULTS	VK1 plasma concentrations were assessed at 0 , 2 , 4 , 5 , 6 , 8 , 10 and 24 h , and the area under the curve was higher in the solution group than in the tablet group ( mean difference 365 g L ( -1 ) h , 95 % confidence interval [ CI ] 230-501 , P < 0.0001 ) .
RESULTS	In the other two trials , the effects of both formulations on the INR were measured at 0 , 24 and 48 h.
RESULTS	In the second trial , on 72 patients on phenprocoumon with planned invasive procedures , both formulations were similarly effective , because all patients reached an INR of < 2.0 , which was the primary endpoint .
RESULTS	In the last trial , on 72 patients on phenprocoumon with an INR of 7.0-11 .0 , the INR decreased slightly more in the solution group ( 4.7 , 95 % CI 4.3-5 .1 ) than in the tablet group ( 4.2 , 95 % CI 3.8-4 .6 ) .
RESULTS	The solution group had a 3.3-fold increased likelihood ( 95 % CI 0.7-15 .1 ) of reaching an INR of < 2.0 at 48 h. Additionally , the increases in VK1 concentrations were similar ( tablets , 3.2 g L ( -1 ) ; solution , 3.4 g L ( -1 ) ; P = 0.99 ) after 24 h.
CONCLUSIONS	VK1 tablets are at least as clinically effective as the solution in countering VKAs .

###24952726
BACKGROUND	For cholecystectomy ( CHE ) , both the needlescopic three-trocar technique with 2-3-mm instruments ( needlescopic cholecystectomy ( NC ) ) and the umbilically assisted transvaginal technique with rigid instruments ( transvaginal cholecystectomy ( TVC ) ) have been established for further reduction of the trauma remaining from laparoscopy .
METHODS	To compare the further outcome of both techniques for elective CHE in female patients , we analyzed the secondary end points of a prospective randomized single-center trial ( needlescopic versus transvaginal cholecystectomy ( NATCH ) trial ; ClinicalTrials.gov Identifier : NCT0168577 ) , in particular , satisfaction with aesthetics , overall satisfaction , abdominal pain , and incidence of trocar hernias postoperatively at both 3 and 6 months .
METHODS	After 3 months , the domains `` satisfaction '' and `` pain '' of the German version of the Female Sexual Function Index ( FSFI-d ) were additionally evaluated to detect respective complications .
METHODS	A gynecological control examination was conducted in all TVC patients after 6 months .
RESULTS	Forty patients were equally randomized into the therapy and the control groups between February 2010 and June 2012 .
RESULTS	No significant differences were found for overall satisfaction with the surgical result , abdominal pain , sexual function , and the rate of trocar hernias .
RESULTS	However , aesthetics were rated significantly better by TVC patients both after 3 and after 6 months ( P = 0.004 and P < 0.001 ) .
RESULTS	There were no postoperative pathological gynecological findings .
CONCLUSIONS	Following TVC , there is a significantly better aesthetic result as compared to NC , even at 3 and 6 months after the procedure .
CONCLUSIONS	No difference was found for sexual function .

###25607702
OBJECTIVE	This randomized , 3-group study compared the efficacy and tolerability of 3 treatment modalities for facial actinic keratoses .
METHODS	Twenty-four healthy adult male and female subjects who had 4 to 8 clinically visible and discrete actinic keratoses on the face in a contiguous 25cm2 treatment area .
METHODS	Subjects were randomized into one of three treatment groups : 2 treatments with 5-aminolevulinic acid ( ALA ) and photodynamic therapy ( PDT ) , 1 ALA-PDT treatment and 1 course of ingenol mebutate ( ingenol mebutate ) 0.015 % gel daily for 3 consecutive days , or 1 course of ingenol mebutate gel alone .
METHODS	Actinic keratoses in the treatment field were counted at the baseline visit , and at the completion of the study ( day 57 or day 71 ) .
METHODS	At the site of application , local site reactions were graded at each visit .
RESULTS	Subjects in the two ALA-PDT treatment group had a 97.5 % mean reduction ( P < 0.00001 ) from the number of baseline actinic keratosis ; ALA-PDT plus ingenol mebutate gel group had an 86.7 % mean reduction ( P < 0.00001 ) ; while subjects in the ingenol mebutate gel alone group had a 91.7 % mean reduction from the number of baseline actinic keratoses .
RESULTS	The peak composite LSR score was 4.625 for the ALA-PDT group , 10.375 for the ALA-PDT followed by ingenol mebutate gel group , and 12.625 for the ingenol mebutate gel alone group ( P = 0.0004 and 0.001 , respectively ) .
CONCLUSIONS	ALA-PDT , ingenol mebutate gel , and a combination of the two treatment modalities are successful topical therapies for the reduction of actinic keratoses on the face .
CONCLUSIONS	The group of subjects receiving 2 consecutive treatments with ALA-PDT , compared to treatment with ingenol mebutate gel alone or sequentially after one course of ALA-PDT had a significantly lower mean composite LSR score and a non-significant trend for greater efficacy .

###25593496
OBJECTIVE	To determine the efficacy of two quintuple regimens for eradication of Helicobacter pylori ( H. pylori ) in patients who failed previous therapies .
METHODS	This prospective , open-label , randomized controlled trial was a phase II study conducted from April 2011 to March 2012 at the Gastrointestinal and Liver Diseases Research Center in Rasht , Iran .
METHODS	A total of 208 patients with dyspepsia who failed previous H. pylori eradication with a ten-day quadruple therapy were enrolled .
METHODS	A random block method was used to assign patients to one of two treatment groups .
METHODS	Patients in the first group were treated with 240 mg bismuth subcitrate , 20 mg omeprazole , 1000 mg amoxicillin , 500 mg clarithromycin and 500 mg tinidazole ( BOACT group ) .
METHODS	Patients in the second group received a regimen containing 240 mg bismuth subcitrate , 20 mg omeprazole , 500 mg tetracycline , 500 mg metronidazole and 200 mg ofloxacin ( BOTMO group ) .
METHODS	Both regimens were given twice daily for a duration of seven days .
METHODS	The eradication was confirmed by a ( 14 ) C urea breath test 12 wk after completion of therapy .
METHODS	Patient compliance and drug side effects were evaluated at the end of the treatment period .
METHODS	The success rates were calculated by intention-to-treat and per-protocol analyses .
RESULTS	A total of 205 patients completed the course of treatment , with three patients excluded due to drug intolerance .
RESULTS	The mean age of patients did not differ between the BOACT and BOTMO groups ( 41.6 12.2 years vs 39.6 11.8 years ) , and no significant differences were found between the two groups in terms of age , sex , smoking habits or the initial eradication regimen .
RESULTS	The intention-to-treat and per-protocol eradication rates were significantly higher in the BOTMO group ( 86.5 % , 95 % CI : 0.85-0 .87 and 86.7 % , 95 % CI : 0.80-0 .89 , respectively ) compared with the BOACT group ( 75.5 % , 95 % CI : 0.73-0 .76 and 76 % , 95 % CI : 0.69-0 .80 , respectively ) ( P < 0.05 ) .
RESULTS	Univariate analyses for both groups did not show any association of sex , smoking and initial therapeutic regimen with eradiation rate ( P > 0.05 for all ) .
RESULTS	Significantly more patients experienced side effects in the BOACT group compared to the BOTMO group ( 77.4 % vs 36.6 % , P < 0.01 ) .
RESULTS	This difference was exemplified by increases in headache and taste disturbance ( P < 0.05 ) .
CONCLUSIONS	Quintuple therapy with a BOTMO regimen is an alternative second-line rescue therapy for Iranian patients with failed first-line eradication treatment of H. pylori .

###26142575
OBJECTIVE	To investigate the effect of sexual intercourse on spontaneous passage of distal ureteral stones .
METHODS	The patients were randomly divided into 3 groups with random number table envelope method .
METHODS	Patients in group 1 were asked to have sexual intercourse at least 3-4 times a week .
METHODS	Patients in group 2 were administered tamsulosin 0.4 mg/d .
METHODS	Patients in group 3 received standard medical therapy alone and acted as the controls .
METHODS	The expulsion rate was controlled after 2 and 4 weeks .
METHODS	Differences in the expulsion rate between groups were compared with the chi-square test for 3 2 tables .
METHODS	P < .05 was considered as statistically significant .
RESULTS	The mean stone size was 4.7 0.8 mm in group 1 , 5 1 mm group 2 , and 4.9 0.8 mm group 3 ( P = .4 ) .
RESULTS	Two weeks later , 26 of 31 patients ( 83.9 % ) in the sexual intercourse group , and 10 of 21 patients ( 47.6 % ) in tamsulosin group passed their stones , whereas 8 of 23 patients ( 34.8 % ) in the control group passed their stones ( P = .001 ) .
RESULTS	The mean stone expulsion time was 10 5.8 days in group 1 , 16.6 8.5 days in group 2 , and 18 5.5 days in group 3 ( P = .0001 ) .
CONCLUSIONS	Our results have indicated that patients who have distal ureteral stones 6 mm and a sexual partner may be advised to have sexual intercourse 3-4 times a week to increase the probability of spontaneous passage of the stones .

###24363238
BACKGROUND	Drugs for migraine attacks include triptans and NSAIDs ; their combination could provide greater symptom relief .
METHODS	A total of 314 subjects with history of migraine , with or without aura , were randomized to frovatriptan 2.5 mg alone ( Frova ) , frovatriptan 2.5 mg + dexketoprofen 25 mg ( FroDex25 ) or frovatriptan 2.5 mg + dexketoprofen 37.5 mg ( FroDex37 .5 ) and treated at least one migraine attack .
METHODS	This was a multicenter , randomized , double-blind , parallel-group study .
METHODS	The primary end point was the proportion of pain free ( PF ) at two hours .
METHODS	Secondary end points were PF at one and four hours , pain relief ( PR ) at one , two , four hours , sustained PF ( SPF ) at 24 and 48 hours , recurrence at 48 hours , resolution of nausea , photophobia and phonophobia at two and four hours , the use of rescue medication and the judgment of the treatment .
RESULTS	The results were assessed in the full analysis set ( FAS ) population , which included all subjects randomized and treated for whom at least one post-dose intensity of headache was recorded .
RESULTS	The proportions of subjects PF at two hours ( primary end point ) were 29 % ( 27/93 ) with Frova compared with 51 % ( 48/95 FroDex25 and 46/91 FroDex37 .5 ) with each combination therapies ( P < 0.05 ) .
RESULTS	Proportions of SPF at 24 hours were 24 % ( 22/93 ) for Frova , 43 % ( 41/95 ) for FroDex25 ( P < 0.001 ) and 42 % ( 38/91 ) for FroDex37 .5 ( P < 0.05 ) .
RESULTS	SPF at 48 hours was 23 % ( 21/93 ) with Frova , 36 % ( 34/95 ) with FroDex25 and 33 % ( 30/91 ) with FroDex37 .5 ( P = NS ) .
RESULTS	Recurrence was similar for Frova ( 22 % , 6/27 ) , FroDex25 ( 29 % , 14/48 ) and FroDex37 .5 ( 28 % , 13/46 ) ( P = NS ) , meaning a lack of improvement with the combination therapy .
RESULTS	Statistical adjustment for multiple comparisons was not performed .
RESULTS	No statistically significant differences were reported in the occurrence of total and drug-related adverse events .
RESULTS	FroDex25 and FroDex37 .5 showed a similar efficacy both for primary and secondary end points .
RESULTS	There did not seem to be a dose response curve for the addition of dexketoprofen .
CONCLUSIONS	FroDex improved initial efficacy at two hours compared to Frova whilst maintaining efficacy at 48 hours in this study .
CONCLUSIONS	Tolerability profiles were comparable .
CONCLUSIONS	Intrinsic pharmacokinetic properties of the two single drugs contribute to this improved efficacy profile .

###25062336
OBJECTIVE	The aim of this study was to compare the efficacy and side effects of prednisolone acetate 1 % versus fluorometholone 0.1 % after Descemet membrane endothelial keratoplasty ( DMEK ) .
METHODS	DMEK recipients used prednisolone acetate 1 % for 1 month , and they were randomized to either prednisolone or fluorometholone for months 2 through 12 .
METHODS	Dosing was 4 times daily in months 1 to 3 , thrice daily in month 4 , twice daily in month 5 , and once daily in months 6 to 12 .
METHODS	The main outcomes were immunologic rejection episodes and intraocular pressure ( IOP ) elevation ( defined as 24 mm Hg or 10 mm Hg increase over the preoperative baseline level ) , assessed by the Kaplan-Meier survival analysis .
RESULTS	The study included 325 eyes ( 99 % were white , 96 % had Fuchs dystrophy , and 9 % had a previous glaucoma diagnosis ) .
RESULTS	No eyes ( 0 % ) assigned to prednisolone versus 2 eyes ( 1.4 % ) assigned to fluorometholone experienced a possible ( n = 1 ) or probable ( n = 1 ) rejection episode ( P = 0.17 ) .
RESULTS	Both rejection episodes resolved successfully with increased topical steroids .
RESULTS	In the prednisolone arm , a significantly higher proportion exceeded the defined IOP elevation threshold ( 22 % vs. 6 % , P = 0.0005 ) , and glaucoma medications were initiated or increased more often ( 17 % vs. 5 % , P = 0.0003 ) .
RESULTS	The most frequent reasons for discontinuing the assigned intervention were IOP management ( n = 13 eyes assigned to prednisolone ) or inflammation management ( n = 3 eyes assigned to fluorometholone ) .
RESULTS	One-year endothelial cell loss was comparable in both arms ( 30 % vs. 31 % , P = 0.50 ) .
CONCLUSIONS	DMEK has a remarkably low rejection episode rate ( < 1 % through 1 year ) , as confirmed in this prospective randomized study .
CONCLUSIONS	This provides a unique opportunity to reduce postoperative topical corticosteroid strength and thereby reduce the risk of steroid-associated complications .

###24760259
OBJECTIVE	Vitamin D deficiency in pregnancy is associated with an increased risk of gestational diabetes mellitus ( GDM ) and neonatal vitamin D deficiency .
OBJECTIVE	We conducted a double-blind , randomized controlled trial of low-dose ( LD ) versus high-dose ( HD ) vitamin D supplementation to investigate the effects of vitamin D supplementation on glucose metabolism during pregnancy .
METHODS	Women with plasma 25-hydroxyvitamin D ( 25OHD ) levels < 32 ng/mL before 20 weeks ' gestation were randomized to oral vitamin D3 at 5,000 IU daily ( HD ) ( n = 89 ) or the recommended pregnancy dose of 400 IU daily ( LD ) ( n = 90 ) until delivery .
METHODS	The primary end point was maternal glucose levels on oral glucose tolerance test ( OGTT ) at 26-28 weeks ' gestation .
METHODS	Secondary end points included neonatal 25OHD , obstetric and other neonatal outcomes , and maternal homeostasis model assessment of insulin resistance .
METHODS	Analysis was by intention to treat .
RESULTS	There was no difference in maternal glucose levels on OGTT .
RESULTS	Twelve LD women ( 13 % ) developed GDM versus seven ( 8 % ) HD women ( P = 0.25 ) .
RESULTS	Neonatal cord 25OHD was higher in HD offspring ( 46 11 vs. 29 12 ng/mL , P < 0.001 ) , and deficiency was more common in LD offspring ( 24 vs. 10 % , P = 0.06 ) .
RESULTS	Post hoc analysis in LD women showed an inverse relationship between pretreatment 25OHD and both fasting and 2-h blood glucose level on OGTT ( both P < 0.001 ) .
RESULTS	Baseline 25OHD remained an independent predictor after multiple regression analysis .
CONCLUSIONS	HD vitamin D supplementation commencing at a mean of 14 weeks ' gestation does not improve glucose levels in pregnancy .
CONCLUSIONS	However , in women with baseline levels < 32 ng/mL , 5,000 IU per day was well tolerated and highly effective at preventing neonatal vitamin D deficiency .

###25147326
OBJECTIVE	The Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial ( ICH ADAPT ) demonstrated blood pressure ( BP ) reduction does not affect mean perihematoma or hemispheric cerebral blood flow .
OBJECTIVE	Nonetheless , portions of the perihematoma and borderzones may reach ischemic thresholds after BP reduction .
OBJECTIVE	We tested the hypothesis that BP reduction after intracerebral hemorrhage results in increased critically hypoperfused tissue volumes .
METHODS	Patients with Intracerebral hemorrhage were randomized to a target systolic BP ( SBP ) of < 150 or < 180 mm Hg and imaged with computed tomographic perfusion 2 hours later .
METHODS	The volumes of tissue below cerebral blood flow thresholds for ischemia ( < 18 mL/100 g/min ) and infarction ( < 12 mL/100 g/min ) were calculated as a percentage of the total volume within the internal and external borderzones and the perihematoma region .
RESULTS	Seventy-five patients with intracerebral hemorrhage were randomized a median ( interquartile range ) of 7.8 ( 13.3 ) hours from onset .
RESULTS	Acute hematoma volume was 17.8 ( 27.1 ) mL and mean SBP was 18322 mm Hg .
RESULTS	At the time of computed tomographic perfusion ( 2.3 [ 1.0 ] hours after randomization ) , SBP was lower in the < 150 mm Hg ( n = 37 ; 14018 mm Hg ) than in the < 180 mm Hg group ( n = 36 ; 16212 mm Hg ; P < 0.001 ) .
RESULTS	BP treatment did not affect the percentage of total borderzone tissue with cerebral blood flow < 18 ( 14.713.6 versus 15.613.7 % ; P = 0.78 ) or < 12 mL/100 g/min ( 5.15.1 versus 5.86.8 % ; P = 0.62 ) .
RESULTS	Similar results were found in the perihematoma region .
RESULTS	Low SBP load ( fraction of time with SBP < 150 mmHg ) did not predict borderzone tissue volume with cerebral blood flow < 18 mL/100 g/min ( = 0.023 [ -0.073 , 0.119 ] ) .
CONCLUSIONS	BP reduction does not increase the volume of critically hypoperfused borderzone or perihematoma tissue .
CONCLUSIONS	These data support the safety of early BP reduction in intracerebral hemorrhage .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00963976 .

###24298783
OBJECTIVE	To verify clinical efficacy of abdominal acupuncture for cyclomastopathy .
METHODS	One hundred and twenty-one cases of cyclomastopathy were randomly divided into an abdominal acupuncture group ( 64 cases ) and a routine treatment group ( 57 cases ) .
METHODS	In the abdominal acupuncture , basic treatment ( including psychological counseling and Chinese patent medicine Rupixiao ) and abdominal acupuncture at Zhongwan ( CV 12 ) , Xiawan ( CV 10 ) , Qihai ( CV 6 ) , Guanyuan ( CV 4 ) and Huaroumen ( ST 24 ) were applied at the same time .
METHODS	In the routine treatment group , only basic treatment was applied .
METHODS	Before and after the treatment , visual analogue scale ( VAS ) of main symptoms and WHO Quality of Life-100BREF score were observed , also clinical efficacy of both groups was compared .
RESULTS	The scores of VAS and WHO Quality of Life-100BREF in both groups had statistical significances before and after the treatment ( both P < 0.05 ) , indicating two treatments could both effectively relieve pain and improve life quality .
RESULTS	The total effective rate was 84.4 % ( 54/64 ) in the abdominal acupuncture group , which was superior to 68.4 % ( 39/57 ) in the routine treatment group ( P < 0.01 ) .
RESULTS	The abdominal acupuncture had best effect for moderate pain ( P < 0.05 ) .
CONCLUSIONS	The abdominal acupuncture could improve clinical symptoms and life quality of patients with cyclomastopathy .

###24593826
BACKGROUND	Recombinant human B-type natriuretic peptide ( rhBNP ) has been indicated for the treatment of acute decompensated heart failure ( ADHF ) .
BACKGROUND	However , the therapeutic efficacy of intravenous rhBNP is not always satisfactory in patients with extremely high blood BNP levels .
BACKGROUND	In this study , we evaluated the effects of rhBNP on patients with different BNP levels .
METHODS	One hundred and five patients with ADHF whose left ventricular ejection fraction ( LVEF ) was < 40 % , were assigned to a high BNP group ( BNP 3000 pg/mL ) or an extra-high BNP group ( BNP > 3000 pg/mL ) , depending on their admission plasma BNP levels .
METHODS	Each group was then subdivided into rhBNP or dobutamine subgroups according to intravenous administration with either rhBNP or dobutamine for 24-72h .
METHODS	In the high BNP group , 58 patients were randomized to subgroup rhBNP ( n = 28 ) and subgroup dobutamine ( n = 30 ) .
METHODS	In the extra-high BNP group , 47 patients were randomized to subgroup rhBNP ( n = 24 ) and subgroup dobutamine ( n = 23 ) .
METHODS	The effects of rhBNP and dobutamine on patients in the high and extra-high BNP groups were compared .
RESULTS	In the high BNP group , rhBNP was more efficient than dobutamine at improving NYHA classification ( P < 0.05 ) , decreasing plasma BNP levels ( P < 0.05 ) , increasing LVEF ( P < 0.05 ) , and reducing hospital length of stay ( P < 0.05 ) .
RESULTS	However , rhBNP displayed no superior therapeutic efficacy to dobutamine in the extra-high BNP group .
RESULTS	Adverse cardiovascular events in patients treated with rhBNP were similar to adverse events in patients treated with dobutamine in both the high and extra-high BNP groups .
CONCLUSIONS	rhBNP was more efficient than dobutamine at improving heart function in patients with ADHF when plasma BNP was 3000 pg/mL .
CONCLUSIONS	However , rhBNP treatment showed no advantages over dobutamine when plasma BNP reached extremely high levels ( > 3000 pg/mL ) .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01837849 .

###24659797
OBJECTIVE	This double-blind , placebo-controlled , dose-finding phase IIb study evaluated the efficacy and safety of ponesimod , an oral selective S1P1 receptor modulator , for the treatment of patients with relapsing-remitting multiple sclerosis ( RRMS ) .
METHODS	464 patients were randomised to receive once-daily oral ponesimod 10 , 20 or 40 mg , or placebo for 24 weeks .
METHODS	The primary endpoint was the cumulative number of new T1 gadolinium-enhanced ( T1 Gd + ) lesions per patient recorded every 4 weeks from weeks 12 to 24 after study drug initiation .
METHODS	Secondary endpoints were the annualised confirmed relapse rate ( ARR ) and time to first confirmed relapse .
METHODS	Safety and tolerability were also evaluated .
RESULTS	The mean cumulative number of new T1 Gd + lesions at weeks 12-24 was significantly lower in the ponesimod 10 mg ( 3.5 ; rate ratio ( RR ) 0.57 ; p = 0.0318 ) , 20 mg ( 1.1 ; RR 0.17 ; p < 0.0001 ) and 40 mg ( 1.4 ; RR 0.23 ; p < 0.0001 ) groups compared with placebo ( 6.2 ) .
RESULTS	The mean ARR was lower with 40mg ponesimod versus placebo , with a maximum reduction of 52 % ( 0.25 vs 0.53 ; p = 0.0363 ) .
RESULTS	The time to first confirmed relapse was increased with ponesimod compared with placebo .
RESULTS	The proportion of patients with 1 treatment-emergent adverse events ( AEs ) was similar across ponesimod groups and the placebo group .
RESULTS	Frequently reported AEs with higher incidence in the three ponesimod groups compared with placebo were anxiety , dizziness , dyspnoea , increased alanine aminotransferase , influenza , insomnia and peripheral oedema .
CONCLUSIONS	Once-daily treatment with ponesimod 10 , 20 or 40 mg significantly reduced the number of new T1 Gd + lesions and showed a beneficial effect on clinical endpoints .
CONCLUSIONS	Ponesimod was generally well tolerated , and further investigation of ponesimod for the treatment of RRMS is under consideration .
BACKGROUND	NCT01006265 .

###24606877
BACKGROUND	Health professionals ' behaviour is a key component in compliance with evidence-based recommendations .
BACKGROUND	Opinion leaders are an oft-used method of influencing such behaviours in implementation studies , but reliably and cost effectively identifying them is not straightforward .
BACKGROUND	Survey and questionnaire based data collection methods have potential and carefully chosen items can - in theory - both aid identification of opinion leaders and help in the design of an implementation strategy itself .
BACKGROUND	This study compares two methods of identifying opinion leaders for behaviour-change interventions .
METHODS	Healthcare professionals working in a single UK mental health NHS Foundation Trust were randomly allocated to one of two questionnaires .
METHODS	The first , slightly longer questionnaire , asked for multiple nominations of opinion leaders , with specific information about the nature of the relationship with each nominee .
METHODS	The second , shorter version , asked simply for a list of named `` champions '' but no more additional information .
METHODS	We compared , using Chi Square statistics , both the questionnaire response rates and the number of health professionals likely to be influenced by the opinion leaders ( i.e. the `` coverage '' rates ) for both questionnaire conditions .
RESULTS	Both questionnaire versions had low response rates : only 15 % of health professionals named colleagues in the longer questionnaire and 13 % in the shorter version .
RESULTS	The opinion leaders identified by both methods had a low number of contacts ( range of coverage , 2-6 each ) .
RESULTS	There were no significant differences in response rates or coverage between the two identification methods .
CONCLUSIONS	The low response and population coverage rates for both questionnaire versions suggest that alternative methods of identifying opinion leaders for implementation studies may be more effective .
CONCLUSIONS	Future research should seek to identify and evaluate alternative , non-questionnaire based , methods of identifying opinion leaders in order to maximise their potential in organisational behaviour change interventions .

###24670079
BACKGROUND	About 10 to 20 % of children in West European countries have atopic dermatitis ( AD ) , often as part of the atopic syndrome .
BACKGROUND	The full atopic syndrome also consists of allergic asthma , allergic rhinitis and food allergy .
BACKGROUND	Treatment approaches for atopic dermatitis and asthma include intermittent anti-inflammatory therapy with corticosteroids , health education and self-management training .
BACKGROUND	However , symptoms persist in a subgroup of patients .
BACKGROUND	Several observational studies have shown significant improvement in clinical symptoms in children and adults with atopic dermatitis or asthma after treatment at high altitude , but evidence on the efficacy when compared to treatment at sea level is still lacking .
METHODS	This study is a pragmatic randomized controlled trial for children with moderate to severe AD within the atopic syndrome .
METHODS	Patients are eligible for enrolment in the study if they are : diagnosed with moderate to severe AD within the atopic syndrome , aged between 8 and 18years , fluent in the Dutch language , have internet access at home , able to use the digital patient system Digital Eczema Center Utrecht ( DECU ) , willing and able to stay in Davos for a six week treatment period .
METHODS	All data are collected at the Wilhelmina Children 's Hospital and DECU .
METHODS	Patients are randomized over two groups .
METHODS	The first group receives multidisciplinary inpatient treatment during six weeks at the Dutch Asthma Center in Davos , Switzerland .
METHODS	The second group receives multidisciplinary treatment during six weeks at the outpatient clinic of the Wilhelmina Children 's Hospital , Utrecht , the Netherlands .
METHODS	The trial is not conducted as a blind trial .
METHODS	The trial is designed with three components : psychosocial , clinical and translational .
METHODS	Primary outcomes are coping with itch , quality of life and disease activity .
METHODS	Secondary outcomes include asthma control , medication use , parental quality of life , social and emotional wellbeing of the child and translational parameters .
CONCLUSIONS	The results of this trial will provide evidence for the efficacy of high altitude treatment compared to treatment at sea level for children with moderate to severe AD .
BACKGROUND	Current Controlled Trials ISRCTN88136485 .

###25342504
BACKGROUND	Nasopharyngeal carcinoma ( NPC ) is one of the most common malignant tumors in southern China .
BACKGROUND	In this study , we compared the clinical efficacy and toxicity of cisplatin with nolatrexed ( LP ) or 5-fluorouracil ( FP ) for NPC .
METHODS	33 patients with metastatic NPC were randomized to the LP and FP regimens .
METHODS	The LP regimen consisted of continuous intravenous infusions of 740 mg/m ( 2 ) nolatrexed on days 1-5 and 25 mg/m ( 2 ) intravenous cisplatin on days 2-4 .
METHODS	The FP regimen consisted of continuous intravenous infusions of 600 mg/m ( 2 ) 5-fluorouracil on days 1-5 and 25 mg/m ( 2 ) intravenous cisplatin on days 2-4 .
METHODS	Cycles were repeated every 3 weeks until disease progression or completion of a total of 6 courses .
RESULTS	There were no significant differences in the response rates ( RR ) , disease control rates ( DCR ) , times to progression ( TTP ) , and median survival times ( MST ) between the regimens .
RESULTS	The toxicities of the two regimens were mostly grade I/II , but the stomatitis incidence in the patients on the LP regimen was significantly lower than that on the FP regimen .
CONCLUSIONS	The efficacy of the LP regimen was similar to that of the FP regimen .
CONCLUSIONS	The LP regimen had lower toxicity .

###25197922
BACKGROUND	This study was designed to prospectively evaluate the role of nebulized hyaluronic acid ( HA ) given for 10 days/mo over 3 months as adjunct treatment to minimize symptoms and preventing exacerbation of chronic rhinosinusitis ( CRS ) .
METHODS	Thirty-nine eligible patients were randomized to receive nebulized 9-mg sodium hyaluronate nasal washes plus saline solution ( 21 patients ) or 5 mL of saline alone ( 18 patients ) , according to an open-label , parallel-group design , with blind observer assessment .
METHODS	A questionnaire about main CRS discomfort and nasal endoscopy for mucous discharge and/or mucosal edema of nasal cavities was used to assess primary outcomes of treatments .
METHODS	Secondary outcome measures included side effects and satisfaction .
RESULTS	HA significantly improved quality of life in CRS patients according to the CRS questionnaire ( 16 3.72 versus 11.52 4.28 ; p < 0.001 ) , contrary to saline group scores ( 18.92 3.09 versus 18.21 3.21 ; p = 0.55 ) .
RESULTS	The HA group showed significantly reduced osteomeatal edema ( 2.42 versus 1.52 ; p < 0.001 ) and secretions ( 0.95 versus 0.42 ; p < 0.001 ) , whereas there was no statistically significant difference in the saline group .
RESULTS	The compliance to the treatment was similar in both groups and no side effects were recorded .
CONCLUSIONS	The results of this study suggested that intermittent treatment with topical 9-mg sodium hyaluronate plays a role in minimizing symptoms and could prevent exacerbations of CRS .

###25194614
OBJECTIVE	Irritable bowel syndrome ( IBS ) is a common diagnosis in gastroenterology .
OBJECTIVE	Its etiology is unknown and therapeutic options limited .
OBJECTIVE	Trials suggest probiotics may be beneficial .
OBJECTIVE	The aim of this study was to assess the symptomatic efficacy of Lactobacillus plantarum 299 v ( L. plantarum 299 v ) for the relief of abdominal pain in patients with IBS fulfilling Rome II criteria .
METHODS	This study was conducted in a referral hospital .
METHODS	Trial participants were randomized to receive either two capsules of L. plantarum 299 v at a dosage of 5 10 ( 9 ) cfu per capsule or placebo daily for 8 wk .
METHODS	Severity of abdominal pain was assessed using a visual analog scale at each visit and a quality-of-life IBS ( QoL-IBS ) questionnaire was also completed .
RESULTS	There was no significant difference in abdominal pain relief between the study and placebo groups ( P = 0.800 ) .
RESULTS	There was also no difference in QoL - IBS scores between the groups ( P = 0.687 ) .
RESULTS	Both groups had a significant improvement in abdominal pain scores over the study period , from an average of 251.55 to 197.90 ( P < 0.0001 ) indicating a large placebo effect .
CONCLUSIONS	An 8-wk treatment with L. plantarum 299 v did not provide symptomatic relief , particularly of abdominal pain and bloating , in patients fulfilling the Rome II criteria .

###24293339
BACKGROUND	Elderly polypharmacy patients may be more at risk of not adhering to medication .
BACKGROUND	If so , the underlying reasons may be more readily disclosed during private discussions with patients .
BACKGROUND	Hence pharmaceutical care discussions at home might improve treatment adherence .
OBJECTIVE	The aim of this study was to investigate the impact of pharmaceutical care on medication adherence , hospitalisation and mortality in elderly patients prescribed polypharmacy .
METHODS	Pharmaceutical care discussed at home .
METHODS	A randomised controlled trial with two arms ; pharmaceutical care ( n = 315 ) and controls ( n = 315 ) was designed .
METHODS	It involved patients aged 65 + years living in Aarhus , Denmark who used five drugs or more without assistance .
METHODS	Pharmacists visited the pharmaceuticalcare patients at home , once only , and followed them during the subsequent year with three telephone calls .
METHODS	Non-adherence was measured by a pill-count .
METHODS	Patients were categorised as non-adherent if their mean adherence rate for all drugs consumed was < 80 % .
METHODS	The impact of pharmaceutical care on non-adherence and hospitalisation was analysed by 2 2 tables , and mortality by Cox regression .
METHODS	Medication adherence , hospitalisation and mortality .
RESULTS	The final analyses included 517 patients ( median age 74 years ; females 52 % ) .
RESULTS	Dropouts were more frequent for the pharmaceutical-care group than for controls .
RESULTS	Pharmacists encountered drug-related problems amongst 72 % of pharmaceutical-care patients .
RESULTS	Pharmaceutical-care patients ( 11 % ) and control patients ( 10 % ) were similarly nonadherent ( Odds ratio 1.14 ; 95 % confidence interval 0.65-2 .00 ) , and similar with respect to hospitalisation frequency ( 30 vs. 28 % ; Odds ratio 1.14 ; 95 % confidence interval 0.78-1 .67 ) and mortality ( 7.5 vs. 5 % ; Hazard ratio 1.41 ; 95 % confidence interval 0.71-2 .82 ) .
CONCLUSIONS	Pharmaceutical care given to our elderly polypharmacy patients made no significant impact on medication adherence , hospitalisation or mortality , when compared to comparable control patients .

###24766337
OBJECTIVE	We aimed to determine the prevalence and risk factors for Strongyloides stercoralis infection in adult patients attending Siriraj Hospital , a tertiary hospital in Thailand .
METHODS	A case-control study was carried out between July 2008 and April 2010 .
METHODS	Case and control were identified from 6022 patients for whom results of faecal examination were available .
METHODS	A case was a patient who had S. stercoralis larva detected from faecal examination .
METHODS	Control was randomly selected from patients without S. stercoralis larvae detected in three consecutive faecal examinations .
METHODS	The proportion of control to case was 2 : 1 .
METHODS	Demographic and clinical data for the day of diagnosis and retrospectively up to 15 days preceding the date of faecal examination were reviewed from their medical records .
RESULTS	Overall , 149 ( 2.47 % ) patients had S. stercoralis larvae positive .
RESULTS	There were 105 males ( 70.5 % ) , with the mean ( SD ) age of 53.9 ( 17.2 ) years .
RESULTS	A total of 300 controls were selected .
RESULTS	Male gender ( odds ratio ( OR ) = 2.79 , 95 % confidence interval ( CI ) 1.78-4 .27 ) ) , human immunodeficiency virus ( HIV ) infection ( OR = 3.23 , 95 % CI 1.43-7 .29 ) , and eosinophilia ( OR = 1.81 , 95 % CI 1.33-2 .47 ) were found to be independent risk factors associated with S. stercoralis infection in this setting .
RESULTS	Corticosteroid or other immunosuppressive treatment , and other concomitant illnesses were not associated with increased risk of S. stercoralis infection .
CONCLUSIONS	In this setting , strongyloidiasis was seen more often in male patients with eosinophilia and with HIV infection .
CONCLUSIONS	Prevention of fatal complication caused by S. stercoralis by regular faecal examination , or serology for early detection and treatment of undiagnosed S. stercoralis infection , is warranted in these high-risk patients .

###25173770
BACKGROUND	We hypothesized that valerian root might prevent cognitive dysfunction in coronary artery bypass graft ( CABG ) surgery patients through stimulating serotonin receptors and anti-inflammatory activity .
OBJECTIVE	The aim of this study was to evaluate the effect of Valeriana officinalis root extract on prevention of early postoperative cognitive dysfunction after on-pump CABG surgery .
METHODS	In a randomized , double-blind , placebo-controlled trial , 61 patients , aged between 30 and 70years , scheduled for elective CABG surgery using cardiopulmonary bypass ( CPB ) , were recruited into the study .
METHODS	Patients were randomly divided into two groups who received either one valerian capsule containing 530mg of valerian root extract ( 1,060 mg/daily ) or placebo capsule each 12h for 8weeks , respectively .
METHODS	For all patients , cognitive brain function was evaluated before the surgery and at 10-day and 2-month follow-up by Mini Mental State Examination ( MMSE ) test .
RESULTS	Mean MMSE score decreased from 27.032.02 in the preoperative period to 26.521.82 at the 10th day and then increased to 27.451.36 at the 60th day in the valerian group .
RESULTS	Conversely , its variation was reduced significantly after 60days in the placebo group , 27.371.87 at the baseline to 241.91 at the 10th day , and consequently slightly increased to 24.831.66 at the 60th day .
RESULTS	Valerian prophylaxis reduced odds of cognitive dysfunction compared to placebo group ( OR = 0.108 , 95 % CI 0.022-0 .545 ) .
CONCLUSIONS	We concluded that , based on this study , the cognitive state of patients in the valerian group was better than that in the placebo group after CABG ; therefore , it seems that the use of V. officinalis root extract may prevent early postoperative cognitive dysfunction after on-pump CABG surgery .

###25063211
OBJECTIVE	To assess lesion detection and diagnostic image quality of filtered back projection ( FBP ) reconstruction technique in ultra low-dose chest CT examinations .
METHODS	In this IRB-approved ongoing prospective clinical study , 116 CT-image-series at four different radiation-doses were performed for 29 patients ( age , 57-87 years ; F : M - 15:12 ; BMI 16-32 kg/m ( 2 ) ) .
METHODS	All patients provided written-informed-consent for the acquisitions of additional ultra low-dose ( ULD ) series on a 256-slice MDCT ( iCT , Philips Healthcare ) .
METHODS	In-addition to their clinical standard-dose chest CT ( SD , 120 kV mean CTDIvol , 6 1 mGy ) , ULD-CT was subsequently performed at three-dose-levels ( 0.9 mGy [ 120 kV ] ; 0.5 mGy [ 100 kV ] and 0.2 mGy [ 80 kV ] ) .
METHODS	Images were reconstructed with FBP ( 2.5 mm 1.25 mm ) resulting into four-stacks : SD-FBP ( reference-standard ) , FBP0 .9 , FBP0 .5 , and FBP0 .2 .
METHODS	Four thoracic-radiologists from two-teaching-hospitals independently-evaluated data for lesion-detection and visibility-of-small-structures .
METHODS	Friedman 's - non-parametric-test with post hoc Dunn 's - test was used for data-analysis .
RESULTS	Interobserver-agreement was substantial between radiologists ( k = 0.6-0 .8 ) .
RESULTS	With pooled analysis , 146-pulmonary ( 27-groundglass-opacities , 64-solid-lung-nodules , 7-consolidations , 27-emphysema ) and 347-mediastinal/soft tissue lesions ( 87-mediastinal , 46-hilar , 62-axillary-lymph-nodes , and 11-mediastinal-masses ) were evaluated .
RESULTS	Compared to the SD-FBP , 100 % pulmonary-lesions were seen with FBP0 .9 , up to 81 % with FBP0 .5 ( missed : 4 ) , and up to 30 % with FBP0 .2 images ( missed :16 ) .
RESULTS	Compared to SD-FBP , all enlarged mediastinal-lymph-nodes were seen with FBP0 .9 images .
RESULTS	All mediastinal-masses ( > 2 cm , 11/11 ) were seen equivalent to SD-FBP images at 0.9 mGy .
RESULTS	Across all sizes of patients , FBP0 .9 images had optimal visualization for lung findings .
RESULTS	They were optimal for mediastinal soft tissues for only non-obese patients .
CONCLUSIONS	Filtered-back-projection technique allows optimal lesion detection and acceptable image quality for chest-CT examinations at CDTIvol of 0.9 mGy for lung and mediastinal findings in selected sizes of patients .

###24382277
OBJECTIVE	We decided to determine the effectiveness of oral bromocriptine in patients with active rheumatoid arthritis ( RA ) who are in methotrexate ( MTX ) therapy .
METHODS	Patients receiving stable doses of MTX were randomized to one of two groups and received 3 months of double-blind bromocriptine ( 5 mg/day ) or matching placebo .
METHODS	The moderate and major outcome measures were the proportion of patients with > 0.6 and > 1.2 improvement in RA based on the Disease Activity Score 28 ( DAS28 ) at 3 months .
METHODS	Safety measures included adverse events and laboratory assessments .
RESULTS	On a background treatment of MTX , the percentage of patients with moderate and major DAS28 responses at 3 months in the bromocriptine group ( 73.8 % / 59.5 % ) was not significantly different from placebo ( 63.1 % / 31.6 % ) .
RESULTS	Side effects were typically mild and included mild nausea and sleep disturbance ; we did not have any adverse events resulting in discontinuation of the study drug .
CONCLUSIONS	In patients with active RA receiving stable doses of MTX , bromocriptine showed non-significant improvement in efficiency outcomes compared to placebo .

###25170833
OBJECTIVE	Growth hormone ( GH ) treatment regimens do not account for the pubertal increase in endogenous GH secretion .
OBJECTIVE	This study assessed whether increasing the GH dose and/or frequency of administration improves pubertal height gain and adult height ( AH ) in children with low GH secretion during stimulation tests , i.e. idiopathic isolated GH deficiency .
METHODS	A multicenter , randomized , clinical trial ( No. 88-177 ) followed 111 children ( 96 boys ) at study start from onset of puberty to AH who had received GH 33 g/kg/day for 1 year .
METHODS	They were randomized to receive 67 g/kg/day ( GH ( 67 ) ) given as one ( GH ( 671 ) ; n = 35 ) or two daily injections ( GH ( 332 ) ; n = 36 ) , or to remain on a single 33 g/kg/day dose ( GH ( 331 ) ; n = 40 ) .
METHODS	Growth was assessed as heightSDSgain for prepubertal , pubertal and total periods , as well as AHSDS versus the population and the midparental height .
RESULTS	Pubertal heightSDSgain was greater for patients receiving a high dose ( GH ( 67 ) , 0.73 ) than a low dose ( GH ( 331 ) , 0.41 , p < 0.05 ) .
RESULTS	AHSDS was greater on GH ( 67 ) ( GH ( 671 ) , -0.84 ; GH ( 332 ) , -0.83 ) than GH ( 33 ) ( -1.25 , p < 0.05 ) , and heightSDSgain was greater on GH ( 67 ) than GH ( 33 ) ( 2.04 and 1.56 , respectively ; p < 0.01 ) .
RESULTS	All groups reached their target heightSDS .
CONCLUSIONS	Pubertal heightSDSgain and AHSDS were dose dependent , with greater growth being observed for the GH ( 67 ) than the GH ( 33 ) randomization group ; however , there were no differences between the once - and twice-daily GH ( 67 ) regimens .
CONCLUSIONS	2014 S. Karger AG , Basel .

###24817063
BACKGROUND	Interventions that improve HbA1c levels do not necessarily improve health-related quality of life ( QoL ) .
BACKGROUND	This issue may be particularly relevant in asymptomatic diabetes patients detected earlier in the course of the disease .
METHODS	HbA1c , diabetes-specific QoL ( ADDQoL ) and health status were measured in 510 screen-detected diabetes patients from the ADDITION-Cambridge trial at 1 and 5 years post diagnosis .
METHODS	Multivariable logistic/linear regression was used to quantify the longitudinal association between change in HbA1c from 1 to 5 years and ADDQoL and health status at 5 years , adjusting for age , sex , education and trial group ; alcohol consumption , smoking , physical activity , plasma vitamin C , HbA1c , ADDQoL or health status at 1 year , and glucose-lowering medication at 5 years .
RESULTS	From 1 to 5 years , median HbA1c interquartile range increased from 6.3 % ( 5.9-6 .8 ) to 6.8 % ( 6.4-7 .4 ) ; the median ADDQoL score and mean health status physical health summary score decreased from -0.4 ( -1 to -0.08 ) to -0.5 ( -1.08 to -0.09 ) ( suggesting an adverse impact of diabetes on QoL ) and by -0.79 ( 8.94 ) points , respectively .
RESULTS	Increases in HbA1c were independently associated with reporting a negative impact of diabetes on QoL ( OR = 1.38 , 95 % CI : 1.03 to 1.85 ) but not with the health status summary scores .
CONCLUSIONS	Increases in HbA1c from 1 to 5 years post-diagnosis were independently associated with increased odds of reporting a negative impact of diabetes on QoL .
CONCLUSIONS	While our results suggest that efforts to reduce HbA1c do not adversely affect health-related QoL , large numbers of participants still report a negative impact of diabetes on their QoL 5 years post-diagnosis .

###24460033
OBJECTIVE	The purpose of the study was to determine the efficacy of a 10 % chlorhexidine tooth coating in reducing the incidence of cavitated carious lesions in adults .
METHODS	The trial was a randomized , double-blind , multi-center , placebo controlled study with 983 participants , receiving the application of either the active or the placebo coatings to the entire dentition .
METHODS	Four applications were made in the first month and one at the 7th month .
METHODS	The final examination was performed at 13 months .
RESULTS	Coronal caries showed a statistical reduction ( p = 0.02 ) .
RESULTS	Examination of the results by site showed that the highest risk participants experienced the most significant preventive effect ( p = 0.003 ) .
RESULTS	When two sites ( uninsured and public health ) are pooled the treatment p-value is 0.0009 , interaction term has a p-value of 0.0001 .
CONCLUSIONS	10 % Chlorhexidine was highly effective in high risk participants with more than two cavities at the initial examination .
CONCLUSIONS	This trial in conjunction with other published trials of this topical medication indicates that chlorhexidine exerts its action by preventing the transition of D1 lesions to cavitated lesions , not on sound to D1 lesions .

###24401022
BACKGROUND	The monoclonal anti-CD20 antibody rituximab , combined with chemotherapeutic agents , has been shown to prolong overall survival in physically fit patients with previously untreated chronic lymphocytic leukemia ( CLL ) but not in those with coexisting conditions .
BACKGROUND	We investigated the benefit of the type 2 , glycoengineered antibody obinutuzumab ( also known as GA101 ) as compared with that of rituximab , each combined with chlorambucil , in patients with previously untreated CLL and coexisting conditions .
METHODS	We randomly assigned 781 patients with previously untreated CLL and a score higher than 6 on the Cumulative Illness Rating Scale ( CIRS ) ( range , 0 to 56 , with higher scores indicating worse health status ) or an estimated creatinine clearance of 30 to 69 ml per minute to receive chlorambucil , obinutuzumab plus chlorambucil , or rituximab plus chlorambucil .
METHODS	The primary end point was investigator-assessed progression-free survival .
RESULTS	The patients had a median age of 73 years , creatinine clearance of 62 ml per minute , and CIRS score of 8 at baseline .
RESULTS	Treatment with obinutuzumab-chlorambucil or rituximab-chlorambucil , as compared with chlorambucil monotherapy , increased response rates and prolonged progression-free survival ( median progression-free survival , 26.7 months with obinutuzumab-chlorambucil vs. 11.1 months with chlorambucil alone ; hazard ratio for progression or death , 0.18 ; 95 % confidence interval [ CI ] , 0.13 to 0.24 ; P < 0.001 ; and 16.3 months with rituximab-chlorambucil vs. 11.1 months with chlorambucil alone ; hazard ratio , 0.44 ; 95 % CI , 0.34 to 0.57 ; P < 0.001 ) .
RESULTS	Treatment with obinutuzumab-chlorambucil , as compared with chlorambucil alone , prolonged overall survival ( hazard ratio for death , 0.41 ; 95 % CI , 0.23 to 0.74 ; P = 0.002 ) .
RESULTS	Treatment with obinutuzumab-chlorambucil , as compared with rituximab-chlorambucil , resulted in prolongation of progression-free survival ( hazard ratio , 0.39 ; 95 % CI , 0.31 to 0.49 ; P < 0.001 ) and higher rates of complete response ( 20.7 % vs. 7.0 % ) and molecular response .
RESULTS	Infusion-related reactions and neutropenia were more common with obinutuzumab-chlorambucil than with rituximab-chlorambucil , but the risk of infection was not increased .
CONCLUSIONS	Combining an anti-CD20 antibody with chemotherapy improved outcomes in patients with CLL and coexisting conditions .
CONCLUSIONS	In this patient population , obinutuzumab was superior to rituximab when each was combined with chlorambucil .
CONCLUSIONS	( Funded by F. Hoffmann-La Roche ; ClinicalTrials.gov number , NCT01010061 . )

###24571754
BACKGROUND	Enterovirus 71 ( EV71 ) is one of the major causative agents of outbreaks of hand , foot , and mouth disease or herpangina worldwide .
BACKGROUND	This phase 3 trial was designed to evaluate the efficacy , safety , and immunogenicity of an EV71 vaccine .
METHODS	We conducted a randomized , double-blind , placebo-controlled , multicenter trial in which 10,007 healthy infants and young children ( 6 to 35 months of age ) were randomly assigned in a 1:1 ratio to receive two intramuscular doses of either EV71 vaccine or placebo , 28 days apart .
METHODS	The surveillance period was 12 months .
METHODS	The primary end point was the occurrence of EV71-associated hand , foot , and mouth disease or herpangina .
RESULTS	During the 12-month surveillance period , EV71-associated disease was identified in 0.3 % of vaccine recipients ( 13 of 5041 children ) and 2.1 % of placebo recipients ( 106 of 5028 children ) in the intention-to-treat cohort .
RESULTS	The vaccine efficacy against EV71-associated hand , foot , and mouth disease or herpangina was 94.8 % ( 95 % confidence interval [ CI ] , 87.2 to 97.9 ; P < 0.001 ) in this cohort .
RESULTS	Vaccine efficacies against EV71-associated hospitalization ( 0 cases vs. 24 cases ) and hand , foot , and mouth disease with neurologic complications ( 0 cases vs. 8 cases ) were both 100 % ( 95 % CI , 83.7 to 100 and 42.6 to 100 , respectively ) .
RESULTS	Serious adverse events occurred in 111 of 5044 children in the vaccine group ( 2.2 % ) and 131 of 5033 children in the placebo group ( 2.6 % ) .
RESULTS	In the immunogenicity subgroup ( 1291 children ) , an anti-EV71 immune response was elicited by the two-dose vaccine series in 98.8 % of participants at day 56 .
RESULTS	An anti-EV71 neutralizing antibody titer of 1:16 was associated with protection against EV71-associated hand , foot , and mouth disease or herpangina .
CONCLUSIONS	The EV71 vaccine provided protection against EV71-associated hand , foot , and mouth disease or herpangina in infants and young children .
CONCLUSIONS	( Funded by Sinovac Biotech ; ClinicalTrials.gov number , NCT01507857 . )

###25132803
BACKGROUND	Ischemic or volatile anesthetic preconditioning is defined as tissue protection from impending ischemic cell damage by repetitive short periods of tissue exposure to ischemia or volatile anesthetics .
BACKGROUND	Objective of this study was to elucidate , if ischemic preconditioning and pharmacological preconditioning with sevoflurane have effects on muscle tissue oxygen saturation in patients undergoing surgical revascularization of the lower limb .
METHODS	In this prospective randomized pilot study ischemic and pharmacological ( sevoflurane ) preconditioning was performed in 40 patients with lower limb arterial occlusive disease undergoing surgical revascularization .
METHODS	Sevoflurane preconditioning was performed in one group ( N = 20 ) by repetitive application of sevoflurane for six minutes interspersed by six minutes of washout .
METHODS	Thereafter , ischemic preconditioning was performed in all patients ( N = 40 ) by repetitive clamping of the femoral artery for six minutes interspersed by six minutes of reperfusion .
METHODS	The effect of both procedures on leg muscle tissue oxygen saturation ( rSO2 ) was measured by near-infrared spectroscopy during both procedures and during surgery and reperfusion ( INVOS 5100C Oxymeter with Small Adult SomaSensor SAFB-SM , Somanetics , Troy , Michigan , USA ) .
RESULTS	Repetitive clamping and reperfusion of the femoral artery resulted in significant cyclic decrease and increase of muscle rSO2 ( p < 0.0001 ) .
RESULTS	Pharmacological preconditioning with sevoflurane resulted in a faster and higher increase of rSO2 during postoperative reperfusion ( Maximal 111 % baseline20 versus 103 % baseline14 , p = 0.008 ) consistent with an additional effect of pharmacological preconditioning on leg perfusion .
CONCLUSIONS	Ischemic preconditioning of lower limb muscle tissue and pharmacological preconditioning with sevoflurane have an effect on tissue oxygenation in patients with lower limb occlusive arterial disease .
BACKGROUND	The trial has been registrated at http://www.ClinicalTrial.gov ,
BACKGROUND	NCT02038062 at 14 January 2014 .

###25033105
OBJECTIVE	To compare stent strut coverage using optical coherence tomography ( OCT ) at three-month follow-up between a PLGA-polymer with electro-grafting base layer sirolimus-eluting stent ( SES ) ( BuMA ) and a PLA-polymer SES ( EXCEL ) .
RESULTS	This prospective , single-centre , non-inferiority randomised BuMA-OCT trial enrolled patients with de novo coronary artery lesions , treated with either the BuMA or the EXCEL stent .
RESULTS	The study primary endpoint was OCT-evaluated stent strut coverage at three months .
RESULTS	Secondary endpoints were neointimal thickness of stent struts , and incomplete stent apposition evaluated with OCT. .
RESULTS	A total of 80 patients were randomly assigned to receive the BuMA ( n = 40 ) or the EXCEL ( n = 40 ) stent .
RESULTS	In OCT follow-up ( achieved in 86.3 % of cases : BuMA , n = 33 ; EXCEL , n = 36 ) , the percentage of stent strut coverage was significantly higher in the BuMA vs. the EXCEL group ( strut level : 94.2 % vs. 90.0 % , p < 0.01 ; p ( non-inferiority ) < 0.0001 ; p ( superiority ) < 0.0001 ) , while the proportion of malapposed struts ( strut level : 1.28 % vs. 1.80 % , p = 0.51 ) and the mean neointimal thickness ( strut level : 0.070.03 mm vs. 0.060.02 mm , p = 0.31 ) were similar .
RESULTS	Rates of myocardial infarction ( periprocedural non-Q-wave , 7.5 % vs. 7.5 % , p = 1.00 ) and target lesion failure ( 7.5 % vs. 7.5 % , p = 1.00 ) were similar between groups , with no cardiac death or stent thrombosis .
CONCLUSIONS	In the BuMA-OCT randomised trial , the novel BuMA PLGA-polymer with electro-grafting base layer SES was superior to the EXCEL PLA-polymer SES in the primary endpoint of stent strut coverage at three-month follow-up .

###25620399
OBJECTIVE	To determine the effect of thermal state and thermal comfort on cycling performance in the heat .
METHODS	Seven well-trained male triathletes completed 3 performance trials consisting of 60 min cycling at a fixed rating of perceived exertion ( 14 ) followed immediately by a 20-km time trial in hot ( 30C ) and humid ( 80 % relative humidity ) conditions .
METHODS	In a randomized order , cyclists either drank ambient-temperature ( 30C ) fluid ad libitum during exercise ( CON ) , drank ice slurry ( -1 C ) ad libitum during exercise ( ICE ) , or precooled with iced towels and ice slurry ingestion ( 15 g/kg ) before drinking ice slurry ad libitum during exercise ( PC+ICE ) .
METHODS	Power output , rectal temperature , and ratings of thermal comfort were measured .
RESULTS	Overall mean power output was possibly higher in ICE ( +1.4 % 1.8 % [ 90 % confidence limit ] ; 0.4 > smallest worthwhile change [ SWC ] ) and likely higher PC+ICE ( +2.5 % 1.9 % ; 1.5 > SWC ) than in CON ; however , no substantial differences were shown between PC+ICE and ICE ( unclear ) .
RESULTS	Time-trial performance was likely enhanced in ICE compared with CON ( +2.4 % 2.7 % ; 1.4 > SWC ) and PC+ICE ( +2.9 % 3.2 % ; 1.9 > SWC ) .
RESULTS	Differences in mean rectal temperature during exercise were unclear between trials .
RESULTS	Ratings of thermal comfort were likely and very likely lower during exercise in ICE and PC+ICE , respectively , than in CON .
CONCLUSIONS	While PC+ICE had a stronger effect on mean power output compared with CON than ICE did , the ICE strategy enhanced late-stage time-trial performance the most .
CONCLUSIONS	Findings suggest that thermal comfort may be as important as thermal state for maximizing performance in the heat .

###24955451
OBJECTIVE	Prior studies have reported 2-L polyethylene glycol ( PEG ) plus ascorbic acid ( PEG + Asc ) is an effective alternative to standard 4-L PEG for bowel preparation before colonoscopy , but they are limited because of some confounders .
OBJECTIVE	Therefore , we compared the efficacy , patient compliance , satisfaction , and safety of 2-L PEG + Asc versus 4-L PEG for bowel cleansing in optimal preparation strategies .
METHODS	In this prospective , randomized , single-blind trial , consenting outpatients were randomly assigned to one of two arms .
METHODS	All colonoscopies were scheduled in the morning and cleansing solutions were administered as a split-dose regimen .
METHODS	Bowel-cleansing efficacy in three different segments was measured on a five-point scale with four-point overall grading .
METHODS	Patients ' opinions of the preparation regimens were obtained by questionnaire .
RESULTS	There was no significant difference between the 2-L PEG + Asc ( 159/163 ; 97.5 % ) and 4-L PEG ( 162/164 ; 98.8 % ) with respect to the overall success of bowel cleansing ( mean difference = -1.3 [ -4.1 - ] ) .
RESULTS	Patient compliance , acceptability , and satisfaction were better in the 2-L PEG + Asc arm than the 4-L PEG arm ( P < 0.05 ) .
RESULTS	Additionally , the incidence of side effects was lower in the 2-L PEG + Asc than the 4-L PEG ( overall , 57.7 % vs 73.2 % , P < 0.05 ) .
RESULTS	However , no significant difference was seen in patients ' rating of taste .
CONCLUSIONS	In an optimal preparation setting , 2-L PEG + Asc has equal efficacy as a bowel cleanser prior to colonoscopy as 4-L PEG , with the advantages of better patient compliance , satisfaction , and safety .

###25326910
BACKGROUND	The use of bupropion , a smoking cessation aid , has been associated with improved health-related quality of life ( HRQOL ) in the general population of smokers ; but , its effect on HRQOL in post-myocardial infarction ( MI ) patients remains unknown .
OBJECTIVE	To examine the effect of bupropion on HRQOL in post-MI patients who are attempting to quit smoking .
METHODS	To accomplish this objective , we used data from a randomized , double-blind , placebo-controlled trial in 392 hospitalized post-MI patients .
METHODS	Treatment duration was 9 weeks , and follow-up was 12 months .
METHODS	HRQOL was assessed via the EuroQol-5D ( EQ-5D ) questionnaire , which includes 5 dimensions ( mobility , self-care , daily activities , pain/discomfort , and anxiety/depression ) .
METHODS	Analyses were restricted to patients ( n = 225 ) who completed the EQ-5D at baseline , 6 months , and 12 months .
RESULTS	Patients randomized to bupropion ( n = 109 ) and those randomized to placebo ( n = 116 ) experienced similar improvements in HRQOL during follow-up ( difference in change in EQ-5D index from baseline to 6 months = 0.02 , 95 % confidence interval [ CI ] = -0.04 , 0.08 ; from baseline to 12 months = 0.02 , 95 % CI = -0.04 , 0.08 ) .
RESULTS	No between-group differences were observed in any of the 5 dimensions .
RESULTS	Similar improvements in HRQOL were observed between patients who remained abstinent and those who relapsed .
RESULTS	Lower baseline HRQOL , defined as having a HRQOL that was less than the median value , was associated with decreased smoking abstinence at 12 months follow-up ( odds ratio OR = 0.39 , 95 % CI = 0.22 , 0.68 ) .
CONCLUSIONS	Bupropion does not improve HRQOL among patients attempting to quit smoking post-MI .

###24368640
OBJECTIVE	To evaluate angiographic and clinical outcomes associated with open and closed dissection tunnel endoscopic vein harvesting ( EVH ) devices .
BACKGROUND	A previous PREVENT-IV ( PRoject of Ex-vivo Vein graft ENgineering via Transfection IV ) analysis reported that EVH for coronary artery bypass graft surgery was associated with worse outcomes than with traditional vein harvesting ; however , outcomes by EVH device type were not available .
METHODS	Using data from the PREVENT-IV trial , we compared 1549 patients from 75 surgical sites who underwent EVH with open ( n = 390 ) or closed ( n = 1159 ) harvest tunnel devices .
METHODS	Outcomes included the incidence of vein graft failure at 12 to 18 months and a composite of death , myocardial infarction , and revascularization through 5 years .
RESULTS	Among patients undergoing open and closed tunnel EVH , no difference in the per-patient incidence of vein graft failure ( 43.8 % vs 47.1 % ; adjusted odds ratio , 0.91 ; 95 % confidence interval , 0.53-1 .55 ; P = 0.724 ) or per-graft incidence of vein graft failure ( 25.5 % vs 25.9 % ; adjusted odds ratio , 0.96 ; 95 % confidence interval , 0.59-1 .55 ; P = 0.847 ) was observed .
RESULTS	At 5 years , no difference was observed in the primary composite clinical outcome between patients who underwent open and closed system EVH ( 21.5 % vs 23.9 % ; adjusted hazard ratio , 0.85 ; 95 % confidence interval , 0.66-1 .10 ; P = 0.221 ) .
CONCLUSIONS	No differences in angiographic or clinical outcomes were observed among patients who underwent open versus closed tunnel endoscopic harvesting for coronary bypass surgery .
CONCLUSIONS	These findings suggest that the risks associated with EVH that were reported in a previous PREVENT-IV analysis are not related to a specific EVH device .

###24438596
OBJECTIVE	Although dry socket ( DS ) is commonly investigated , many of its risk factors remain highly controversial .
OBJECTIVE	In addition , few studies are available to show the preventive effect of chlorhexidine gel on DS .
OBJECTIVE	Moreover , multivariable analyses of DS risk factors are scarce , and their interactions have not been assessed previously .
OBJECTIVE	Therefore , the simultaneous effect of chlorhexidine gel and 4 DS risk factors and their interactions were analyzed within a multivariable framework .
METHODS	Using a split-mouth randomized clinical trial design , the investigators enrolled a cohort of patients requiring extraction of 2 mandibular third molars .
METHODS	The primary predictor variable was extraction socket treatment status , classified as experimental or standard .
METHODS	Experimental treatment was the insertion of chlorhexidine gel ( 0.2 % ) into the extraction socket .
METHODS	Each patient had 1 third molar randomly selected as the treatment site .
METHODS	The contralateral third molar served as the control socket and was treated in the usual manner .
METHODS	The primary outcome variable was DS status , present or absent , assessed on postoperative day 3 .
METHODS	Other study variables were categorized as demographic , smoking , and surgical difficulty according to the Pederson scale .
METHODS	Appropriate bivariate and multiple logistic regression statistics were used to measure the association between risk for DS and chlorhexidine gel use , age , gender , smoking , and surgical difficulty and their interactions ( = 0.05 ) .
RESULTS	The sample consisted of 90 bilateral extraction sockets in 45 patients ( 24 men ; 21 smokers ; mean age , 21.1 2.7 yr ) .
RESULTS	Regression analysis showed that when other factors and their interactions were controlled for , chlorhexidine gel application lowered the risk of DS ( odds ratio [ OR ] = 0.05 ; P = .004 ) .
RESULTS	Increasing age ( OR = 2.9 ; P = .030 ) was associated with an increased risk for DS .
RESULTS	A similar association existed between increased difficulty level of extraction and DS risk ( OR = 3.8 ; P = .051 ) .
RESULTS	The effect of gender was marginally significant ( P = .091 ) , whereas smoking did not have a significant influence ( P = .4 ) .
CONCLUSIONS	Intra-alveolar application of chlorhexidine gel and practicing less traumatic surgeries are advocated , particularly in older patients .
CONCLUSIONS	Smoking seems unlikely to affect DS frequency .
CONCLUSIONS	The role of gender is inconclusive .

###24617224
OBJECTIVE	To observe the lower gastrointestinal mesenchymal tumors CT virtual endoscopy and pathology , and to explore its possible mechanism .
METHODS	Select 80 patients suspected colon gastroenterology treat in the hospital gastroenterology department , randomly divided into experimental group and control group , 40 cases in experimental group were given CT virtual endoscopy and pathological check , the control group received conventional colonoscopy and pathological check , and all the results compared with the pathological results .
RESULTS	Compared with the pathological test results , consistent rate with the experimental group reached 94.73 % , the same rate was 92.85 % in control group .
RESULTS	The difference was not statistically significant ( P > 0.05 ) .
CONCLUSIONS	CT virtual endoscopy can quickly image and draw detailed information , and can improve the sensitivity and specificity of cancer diagnosis greatly .
CONCLUSIONS	Clinically , CT virtual endoscopy have the same function as colonoscopy , can replace colonoscopy , can be important complement of electronic colonoscopy by those who can not tolerate electronic colonoscopy or have contraindications .
CONCLUSIONS	Its value is worth taking a step forward in-depth study .

###24771618
OBJECTIVE	Weight losses in lifestyle interventions are variable , yet prediction of long-term success is difficult .
OBJECTIVE	The utility of using various weight loss thresholds in the first 2 months of treatment for predicting 1-year outcomes was examined .
METHODS	Participants included 2327 adults with type 2 diabetes ( BMI :35.86.0 ) randomized to the intensive lifestyle intervention ( ILI ) of the Look AHEAD trial .
METHODS	ILI included weekly behavioral sessions designed to increase physical activity and reduce caloric intake .
METHODS	1-month , 2-month , and 1-year weight changes were calculated .
RESULTS	Participants failing to achieve a 2 % weight loss at Month 1 were 5.6 ( 95 % CI :4.5 , 7.0 ) times more likely to also not achieve a 10 % weight loss at Year 1 , compared to those losing 2 % initially .
RESULTS	These odds were increased to 11.6 ( 95 % CI :8.6 , 15.6 ) when using a 3 % weight loss threshold at Month 2 .
RESULTS	Only 15.2 % and 8.2 % of individuals failing to achieve the 2 % and 3 % thresholds at Months 1 and 2 , respectively , go on to achieve a 10 % weight loss at Year 1 .
CONCLUSIONS	Given the association between initial and 1-year weight loss , the first few months of treatment may be an opportune time to identify those who are unsuccessful and utilize rescue efforts .
BACKGROUND	clinicaltrials.gov Identifier : NCT00017953 .

###25462663
BACKGROUND	The rapid rise in the number of methamphetamine users , relative to cocaine users , has brought the number of each to nearly equal levels , making research on similarities and differences across these groups a needed area of exploration .
BACKGROUND	Craving is postulated to play a significant role in relapse for both user types , yet group differences on observed scale scores have been reported without first assessing the prerequisite measurement equivalence ( invariance ) of the items , which is essential for meaningful group comparisons .
METHODS	Baseline data from stimulant users in residential treatment ( N = 301 ; n = 177 cocaine ; n = 124 methamphetamine ) were used to assess the measurement invariance of the 10-item Stimulant Craving Questionnaire ( STCQ ) , which was adapted from a cocaine-specific measure .
RESULTS	The unifactorial STCQ demonstrated measurement invariance across cocaine and methamphetamine users for factor loadings ( metric ) , common residual covariances between item pairs , and item intercepts ( scalar ) , as determined by fit indices ( RMSEA < 0.05 ; CFI & TLI > 0.95 ; SRMR < 0.10 ) .
RESULTS	The latent mean , as well as 5 ( out of 10 ) item means and the overall composite scale score , was significantly greater for methamphetamine users compared to cocaine users .
CONCLUSIONS	Results indicate the STCQ is an invariant tool for the assessment of stimulant craving across the two most prevalent user types .
CONCLUSIONS	Methamphetamine users had significantly higher levels of observed and latent craving than cocaine users , demonstrating a potentially meaningful difference in craving between users of these two stimulants .
CONCLUSIONS	Future research will determine if treatments and statistical models need to account for craving variations across methamphetamine and cocaine users .

###24522636
OBJECTIVE	The COPD Assessment Test ( CAT ) has been proposed for assessing health status in COPD , but little is known about its longitudinal changes .
OBJECTIVE	The objective of this study was to evaluate 1-year CAT variability in patients with stable COPD and to relate its variations to changes in other disease markers .
METHODS	We evaluated the following variables in smokers with and without COPD at baseline and after 1 year : CAT score , age , sex , smoking status , pack-year history , BMI , modified Medical Research Council ( mMRC ) scale , 6-min walk distance ( 6MWD ) , lung function , BODE ( BMI , obstruction , dyspnea , exercise capacity ) index , hospital admissions , Hospital and Depression Scale , and the Charlson comorbidity index .
METHODS	In patients with COPD , we explored the association of CAT scores and 1-year changes in the studied parameters .
RESULTS	A total of 824 smokers with COPD and 126 without COPD were evaluated at baseline and 441 smokers with COPD and 66 without COPD 1 year later .
RESULTS	At 1 year , CAT scores for patients with COPD were similar ( 4 points ) in 56 % , higher in 27 % , and lower in 17 % .
RESULTS	Of note , mMRC scale scores were similar ( 1 point ) in 46 % of patients , worse in 36 % , and better in 18 % at 1 year .
RESULTS	One-year CAT changes were best predicted by changes in mMRC scale scores ( - coefficient , 0.47 ; P < .001 ) .
RESULTS	Similar results were found for CAT and mMRC scale score in smokers without COPD .
CONCLUSIONS	One-year longitudinal data show variability in CAT scores among patients with stable COPD similar to mMRC scale score , which is the best predictor of 1-year CAT changes .
CONCLUSIONS	Further longitudinal studies should confirm long-term CAT variability and its clinical applicability .
BACKGROUND	ClinicalTrials.gov ; No. : NCT01122758 ; URL : www.clinicaltrials.gov .

###24800335
BACKGROUND	Urethral stricture is one of the oldest diseases Urethral dilatation Internal optical urethrotomy , were the only treatment .
BACKGROUND	Clean Intermittent Self Catheterisation was introduced by Lapides has greatly decreased the recurrence of stricture .
BACKGROUND	Objectives were to determine the role of Clean Intermittent Self Catheterisation ( CISC ) in the prevention of recurrence of urethral strictures after Internal Optical Urethrotomy and to study the frequency of any postoperative complications and tolerability for the patients associated with this procedure .
METHODS	A randomised controlled study conducted in the department of urology and renal transplantation , Institute of Kidney Diseases Hayatabad Medical Complex , Peshawar from June 2007 to June 2010 .
METHODS	Total of 60 patients with mean age 48 years ( range 20-73 ) were selected and randomly divided into Treatment Group ( 30 patients ) and Control Group ( 30 Patients ) .
METHODS	Eight `` drop out '' occurred in the treatment group and four `` drop out '' occurred in the controlled group .
METHODS	All the patients were treated with Internal Optical Urethrotomy using Sachse method followed by indwelling catheter for 5 days .
METHODS	The treatment group was then taught to perform Clean Intermittent Self Catheterisation by inserting a Classic Neleton Catheter ( No. 16 or 18 ) twice a day for 1 week , then once a day for another 4 weeks and then once weekly continued for one year .
METHODS	All the patients were followed up regularly at 1 month intervals during the first 6 months and then every 2 months for the next 6 months .
RESULTS	Total of 48 patients completed the study , 22 in the treatment group and 26 in the control group .
RESULTS	Within the first year , 4 patients ( 22 % ) in the treatment group developed urethral stricture .
RESULTS	In the control group , 12 patients ( 46 % ) developed urethral stricture within the first year , showing a significant difference ( p < 0.01 ) .
RESULTS	In the treatment group four patients developed simple UTIs while in the control group three patients developed UTIs , one with concomitant epididymitis .
RESULTS	No other complications were noted up to one year follow up .
CONCLUSIONS	Clean Intermittent Self Catheterisation is a simple and effective way of reducing stricture recurrence after Internal Optical Urethrotomy and is associated with less morbidity and is cost effective .
CONCLUSIONS	CISC is an important modality for maintaining the normal urethral calibre .

###25596202
BACKGROUND	Otitis media ( OM ) starts within weeks of birth in almost all Indigenous infants living in remote areas of the Northern Territory ( NT ) .
BACKGROUND	OM and associated hearing loss persist from infancy throughout childhood and often into adulthood .
BACKGROUND	Educational and social opportunities are greatly compromised .
BACKGROUND	Pneumococcus and non-typeable Haemophilus influenzae ( NTHi ) are major OM pathogens that densely colonise the nasopharynx and infect the middle ear from very early in life .
BACKGROUND	Our hypothesis is that compared to current single vaccine schedules , a combination of vaccines starting at 1month of age , may provide earlier , broadened protection .
METHODS	This randomised outcome assessor , blinded controlled trial will recruit 425 infants between 28 and 38days of age and randomly allocate them ( 1:1:1 ) to one of three pneumococcal conjugate vaccine ( PCV ) schedules : Synflorix at 2 , 4 , 6months of age , Prevenar13 at 2 , 4 and 6months of age , or an investigational schedule of Synflorix at 1 , 2 and 4months plus Prevenar13 at 6months of age .
METHODS	The blinded primary outcomes at 7months of age are immunogenicity of specific vaccine antigens ( geometric mean concentration ( GMC ) and proportion of participants with above threshold GMC of 0.35 g/L ) .
METHODS	Secondary outcomes at all timepoints are additional immunogenicity measures and proportion of participants with nasopharyngeal carriage of vaccine-type pneumococci and NTHi , and any OM , including any tympanic membrane perforation .
METHODS	Parental interviews will provide data on common risk factors for OM .
BACKGROUND	Ethical approval has been obtained from NT Department of Health and Menzies HREC ( EC00153 ) , Central Australian HREC ( EC00155 ) and West Australian Aboriginal Health Ethics Committee ( WAAHEC - 377-12/2011 ) .
BACKGROUND	Final trial results , data analyses , interpretation and conclusions will be presented in appropriate written and oral formats to parents and guardians , participating communities , local , national and international conferences , and published in peer-reviewed open access journals .
BACKGROUND	ACTRN12610000544077 and NCT01174849 .

###24240835
BACKGROUND	Severe knee contractures that develop soon after muscle imbalance may not improve with stretching exercises and splinting .
BACKGROUND	An alternative treatment is serial casting , which has been used to promote increased range of motion .
OBJECTIVE	The purpose of this study was to compare the effectiveness of using serial casting and passive stretching approaches to treat knee flexion contracture in children with spina bifida .
METHODS	In a pre/post randomized controlled study , ten participants were included in the serial casting group , while eight participants were included in the passive stretching intervention group .
METHODS	The degree of knee extension was measured at baseline , immediately after intervention , and at a one-year follow-up using a standard goniometer .
RESULTS	Both groups showed significant improvements in the degree of flexion contracture at the post-treatment evaluation and the follow-up evaluation .
RESULTS	The serial casting group showed significant improvements in knee flexion contracture at the post-treatment evaluation , t ( 9 ) = 13.4 , p < 0.001 , and the one-year follow-up evaluation , t ( 9 ) = 7.46 , p < 0.001 .
RESULTS	The passive stretching group also showed significant improvements in knee flexion contracture at the post-treatment evaluation , t ( 7 ) = 2.6 , p < 0.05 , and the one-year follow-up evaluation , t ( 7 ) = 3.6 , p < 0.05 .
RESULTS	However , statistically significant improvements in the serial casting group compared with passive stretching group in relation to the degree of flexion contracture were found at the immediate post-treatment evaluation , F ( 1 , 15 ) = 246 , p = 0.0001 , and the one-year follow-up evaluation , F ( 1 , 15 ) = 51.5 , p = 0.0001 .
CONCLUSIONS	The outcomes of this study provide the first evidence that serial casting may be a useful intervention in treating knee flexion contracture in children with spina bifida .
CONCLUSIONS	However , further investigations into serial casting , as well as investigations into the use of serial casting with other interventions , are warranted .

###25783757
OBJECTIVE	The authors tested whether clonidine blocks stress-induced seeking of heroin and cocaine .
OBJECTIVE	The study was also intended to confirm translational findings from a rat model of drug relapse by using ecological momentary assessment of patients ' stress to test hypotheses about clonidine 's behavioral mechanism of action .
METHODS	The authors conducted a randomized double-blind placebo-controlled clinical trial with 208 opioid-dependent patients at an outpatient buprenorphine clinic .
METHODS	The 118 participants ( 57 % ) who maintained abstinence during weeks 5-6 were continued on buprenorphine and randomly assigned to receive clonidine ( N = 61 ) or placebo ( N = 57 ) for 14 weeks .
METHODS	Urine was tested thrice weekly .
METHODS	Lapse was defined as any opioid-positive or missed urine test , and relapse as two or more consecutive lapses .
METHODS	Time to lapse and relapse were examined with Cox regressions ; longest period of abstinence was examined with a t test , and ecological momentary assessment data were examined with generalized linear mixed models .
RESULTS	In an intent-to-treat analysis , clonidine produced the longest duration ( in consecutive days ) of abstinence from opioids during the intervention phase ( 34.8 days [ SD = 3.7 ] compared with 25.5 days [ SD = 2.7 ] ; Cohen 's d = 0.38 ) .
RESULTS	There was no group difference in time to relapse , but the clonidine group took longer to lapse ( hazard ratio = 0.67 , 95 % CI = 0.45-1 .00 ) .
RESULTS	Ecological momentary assessment showed that daily-life stress was partly decoupled from opioid craving in the clonidine group , supporting the authors ' hypothesized mechanism for clonidine 's benefits .
CONCLUSIONS	Clonidine , a readily available medication , is useful in opioid dependence not just for reduction of withdrawal signs , but also as an adjunctive maintenance treatment that increases duration of abstinence .
CONCLUSIONS	Even in the absence of physical withdrawal , it decouples stress from craving in everyday life .

###24497658
OBJECTIVE	Evaluate long-term effects of group interventions on sleep and pain outcomes in a primary care population of older adults with osteoarthritis pain and sleep disturbance .
METHODS	Double-blind , cluster-randomized controlled trial with 18-mo follow-up .
METHODS	Group Health and University of Washington , Seattle , WA , from 2009 to 2011 .
METHODS	Three hundred sixty-seven adults age 60 y and older , with osteoarthritis pain and insomnia symptoms .
METHODS	Six weekly sessions of group cognitive behavioral therapy for insomnia and pain ( CBT-PI ) , pain alone ( CBT-P ) , and education-only control ( EOC ) delivered in patients ' primary care clinics .
RESULTS	There were no significant differences between treatment groups in sleep outcomes at 18 mo. .
RESULTS	This is a change from published significant 9-mo follow-up results for insomnia severity ( Insomnia Severity Index ) and sleep efficiency .
RESULTS	There were no significant treatment differences in pain at either follow-up .
RESULTS	Post hoc analyses of participants with greater insomnia and pain severity at baseline ( n = 98 ) showed significant ( P = 0.01 ) 18-mo reductions in pain comparing CBT-PI versus CBT-P ( adjusted mean difference [ AMD ] = -1.29 [ 95 % confidence interval ( CI ) : -2.24 , -0.33 ] ) .
RESULTS	Moderate , albeit nonsignificant , CBT-PI versus EOC treatment effects for insomnia severity ( AMD = -1.43 [ 95 % CI : -4.71 , 1.86 ] ) and sleep efficiency ( AMD = 2.50 [ 95 % CI : -5.04 , 10.05 ] ) were also observed .
RESULTS	Possible trial design and methodological considerations that may have affected results are discussed .
CONCLUSIONS	Results suggest patients with higher levels of comorbid pain and insomnia may be most likely to experience sustained benefit from cognitive behavioral therapy interventions over time , and inclusion of insomnia treatment may yield more clinically meaningful improvements than cognitive behavioral therapy for pain alone .
BACKGROUND	clinicaltrials.gov identifier : NCT01142349 .

###24615948
OBJECTIVE	To compare the efficacy of two standard surgical procedures for post-hysterectomy vaginal vault prolapse in patients with levator ani avulsion .
METHODS	This was a single-center , randomized interventional trial , of two standard surgical procedures for post-hysterectomy vaginal vault prolapse : Prolift Total vs unilateral vaginal sacrospinous colpopexy with native tissue vaginal repair ( sacrospinous fixation , SSF ) , during the period from 2008 to 2011 .
METHODS	Entry criteria included at least two-compartment prolapse , as well as complete unilateral or bilateral levator ani avulsion injury .
METHODS	The primary outcome was anatomical failure based on clinical and ultrasound assessment .
METHODS	Failure was defined clinically , according to the Pelvic Organ Prolapse Quantification system , as Ba , C or Bp at the hymen or below , and on translabial ultrasound as bladder descent to 10 mm or more below the lower margin of the symphysis pubis on maximum Valsalva maneuver .
METHODS	Secondary outcomes were evaluation of continence , sexual function and prolapse symptoms based on validated questionnaires .
RESULTS	During the study period , 142 patients who were post-hysterectomy underwent surgery for prolapse in our unit ; 72 of these were diagnosed with an avulsion injury and were offered participation in the study .
RESULTS	Seventy patients were randomized into two groups : 36 in the Prolift group and 34 in the SSF group .
RESULTS	On clinical examination at 1-year follow-up , we observed one ( 3 % ) case of anatomical failure in the Prolift group and 22 ( 65 % ) in the SSF group ( P < 0.001 ) .
RESULTS	Using ultrasound criteria , there was one ( 2.8 % ) failure in the Prolift group compared with 21 ( 61.8 % ) in the SSF group ( P < 0.001 ) .
RESULTS	The postoperative POPDI ( Pelvic Organ Prolapse Distress Inventory ) score for subjective outcome was 15.3 in the Prolift group vs 21.7 in the SSF group ( P = 0.16 ) .
CONCLUSIONS	In patients with prolapse after hysterectomy and levator ani avulsion injury , SSF has a higher anatomical failure rate than does the Prolift Total procedure at 1-year follow-up .

###25237669
OBJECTIVE	The aim of this randomised controlled trial was to assess the clinical performance of single crowns in the posterior maxilla supported by either 6-mm or 11-mm implants combined with maxillary sinus floor elevation .
METHODS	41 consecutive patients with one missing premolar or molar in the posterior maxilla and with an estimated bone height of 6 to 8 mm in that area were included .
METHODS	Each patient was randomly allocated to one of the two treatment groups , namely to receive an 11-mm implant ( Osseo Speed 4.0 S , Dentsply Implants , Mlndal , Sweden ) in combination with maxillary sinus floor elevation surgery or to receive a 6-mm implant ( Osseo Speed 4.0 S ) without any grafting .
METHODS	After a 3-month osseointegration period , all implants were restored with custom-made titanium abutments and cemented zirconia-based porcelain crowns .
METHODS	Outcome measures were : implant survival ; radiographic bone changes ; plaque accumulation ; bleeding tendency ; peri-implant inflammation ; presence of dental calculus ; biological and technical complications ; and patients ' satisfaction .
METHODS	Clinical and radiographic examinations were performed at placement of the crown and 12 months thereafter .
METHODS	Patients ' satisfaction was scored before treatment and after 12 months of functioning of the crown .
RESULTS	One patient of the 11 mm implant group died during the follow-up .
RESULTS	No implant failed and no biological or technical complications occurred .
RESULTS	From loading to the 12 months follow-up , no difference was found in mean marginal bone changes between the groups ( bone resorption in both groups 0.1 0.3 mm ) .
RESULTS	Clinical items revealed very healthy peri-implant soft tissues in both groups .
RESULTS	Patients ' satisfaction scores were high in both groups .
CONCLUSIONS	6-mm implants and 11-mm implants combined with sinus floor elevation surgery are equally successful to support a single crown in the resorbed posterior maxilla after 1-year follow-up .

###25023786
OBJECTIVE	In accordance with the European Association of Urology guidelines , a second transurethral resection of the bladder ( TURB ) is recommended for high-grade or T1-category tumors .
OBJECTIVE	This practice brings into question the benefit of photodynamic diagnosis ( PDD ) in reducing the residual disease after TURB in patients with positive results on urine cytology showing high-grade cancer cells .
METHODS	A prospective , bicentric , randomized study comparing white light cystoscopy ( WLC ) + PDD with hexaminolevulinate arm with WLC alone ( control arm ) during the first TURB in patients with primary non-muscle-invasive bladder cancer and with positive results on urine cytology showing high-grade cancer cells .
METHODS	Patients underwent a first TURB with WLC and PDD or WLC alone , and then a second TURB with WLC and PDD , after 4 to 6 weeks .
METHODS	The number of tumors visualized in WLC and PDD and histology of the TURB specimen was recorded to perform a statistical analysis comparing both the 2 arms .
RESULTS	A total of 151 patients were enrolled ( hexaminolevulinate , n = 72 ; control , n = 79 ) .
RESULTS	The number of visualized tumors did not increase with PDD in the first or second TURB .
RESULTS	During the second TURB , the residual tumor rate was not reduced in patients who had PDD during the first TURB .
RESULTS	No significant difference was observed regarding the pattern of category and grade , the size , and the recurrence and progression risks during either the first or the second TURB .
CONCLUSIONS	In the setting of primary non-muscle-invasive bladder cancer with positive results on urine cytology , performing a second TURB allows to diagnose residual tumor in approximately half of the cases .
CONCLUSIONS	This rate was not significantly reduced by the use of the PDD during the first TURB .

###24552319
BACKGROUND	Recent guidance for the management of acute otorrhea in children with tympanostomy tubes is based on limited evidence from trials comparing oral antibiotic agents with topical antibiotics .
METHODS	In this open-label , pragmatic trial , we randomly assigned 230 children , 1 to 10 years of age , who had acute tympanostomy-tube otorrhea to receive hydrocortisone-bacitracin-colistin eardrops ( 76 children ) or oral amoxicillin-clavulanate suspension ( 77 ) or to undergo initial observation ( 77 ) .
METHODS	The primary outcome was the presence of otorrhea , as assessed otoscopically , 2 weeks after study-group assignment .
METHODS	Secondary outcomes were the duration of the initial otorrhea episode , the total number of days of otorrhea and the number of otorrhea recurrences during 6 months of follow-up , quality of life , complications , and treatment-related adverse events .
RESULTS	Antibiotic-glucocorticoid eardrops were superior to oral antibiotics and initial observation for all outcomes .
RESULTS	At 2 weeks , 5 % of children treated with antibiotic-glucocorticoid eardrops had otorrhea , as compared with 44 % of those treated with oral antibiotics ( risk difference , -39 percentage points ; 95 % confidence interval [ CI ] , -51 to -26 ) and 55 % of those treated with initial observation ( risk difference , -49 percentage points ; 95 % CI , -62 to -37 ) .
RESULTS	The median duration of the initial episode of otorrhea was 4 days for children treated with antibiotic-glucocorticoid eardrops versus 5 days for those treated with oral antibiotics ( P < 0.001 ) and 12 days for those who were assigned to initial observation ( P < 0.001 ) .
RESULTS	Treatment-related adverse events were mild , and no complications of otitis media , including local cellulitis , perichondritis , mastoiditis , and intracranial complications , were reported at 2 weeks .
CONCLUSIONS	Antibiotic-glucocorticoid eardrops were more effective than oral antibiotics and initial observation in children with tympanostomy tubes who had uncomplicated acute otorrhea .
CONCLUSIONS	( Funded by the Netherlands Organization for Health Research and Development ; Netherlands Trial Register number , NTR1481 . )

###24818542
OBJECTIVE	We compare efficacy of ondansetron and metoclopramide with placebo for adults with undifferentiated emergency department ( ED ) nausea and vomiting .
METHODS	A prospective , randomized , double-blind , placebo-controlled trial was conducted in 2 metropolitan EDs in Melbourne , Australia .
METHODS	Eligible patients with ED nausea and vomiting were randomized to receive 4 mg intravenous ondansetron , 20 mg intravenous metoclopramide , or saline solution placebo .
METHODS	Primary outcome was mean change in visual analog scale ( VAS ) rating of nausea severity from enrollment to 30 minutes after study drug administration .
METHODS	Secondary outcomes included patient satisfaction , need for rescue antiemetic treatment , and adverse events .
RESULTS	Of 270 recruited patients , 258 ( 95.6 % ) were available for analysis .
RESULTS	Of these patients , 87 ( 33.7 % ) received ondansetron ; 88 ( 34.1 % ) , metoclopramide ; and 83 ( 32.2 % ) , placebo .
RESULTS	Baseline characteristics between treatment groups and recruitment site were similar .
RESULTS	Mean decrease in VAS score was 27 mm ( 95 % confidence interval [ CI ] 22 to 33 mm ) for ondansetron , 28 mm ( 95 % CI 22 to 34 mm ) for metoclopramide , and 23 mm ( 95 % CI 16 to 30 mm ) for placebo .
RESULTS	Satisfaction with treatment was reported by 54.1 % ( 95 % CI 43.5 % to 64.5 % ) , 61.6 % ( 95 % CI 51.0 % to 71.4 % ) , and 59.5 % ( 95 % CI 48.4 % to 69.9 % ) for ondansetron , metoclopramide , and placebo , respectively ; rescue medication was required by 34.5 % ( 95 % CI 25.0 % to 45.1 % ) , 17.9 % ( 95 % CI 10.8 % to 27.2 % ) , and 36.3 % ( 95 % CI 26.3 % to 47.2 % ) , respectively .
RESULTS	Nine minor adverse events were reported .
CONCLUSIONS	Reductions in nausea severity for this adult ED nausea and vomiting population were similar for 4 mg intravenous ondansetron , 20 mg intravenous metoclopramide , and placebo .
CONCLUSIONS	There was a trend toward greater reductions in VAS ratings and a lesser requirement for rescue medication in the antiemetic drug groups , but differences from the placebo group did not reach significance .
CONCLUSIONS	The majority of patients in all groups were satisfied with treatment .

###24617961
BACKGROUND	Telemedicine holds great potential to improve access to care and to reduce barriers to treatment for military populations with posttraumatic stress disorder ( PTSD ) .
BACKGROUND	This study sought to integrate the use of telemedicine mental health treatment services by a community healthcare provider to military populations residing in a rural location and to compare the equivalency of cognitive behavioral therapy ( CBT ) administered via telemedicine and traditional face-to-face therapy .
METHODS	Study subjects were men or women 18 years of age or older who had served in Operation Enduring Freedom ( OEF ) and/or Operation Iraqi Freedom ( OIF ) and were diagnosed with PTSD .
METHODS	The 18 study subjects were randomized and provided 10 weekly therapy sessions of CBT .
METHODS	Pre - and post-intervention assessments were conducted using the Clinician Administered PTSD Scale ( CAPS ) , Hamilton Anxiety Rating Scale ( HAM-A ) , Montgomery-Asberg Depression Rating Scale ( MADRS ) , Life Events Checklist , and SF-36v2 ( QualityMetric , Lincoln , RI ) Health Survey .
RESULTS	The CAPS , HAM-A , and MADRS each demonstrated lower scores , signifying improvement , and 69 % of subjects experienced a clinically significant change in the CAPS .
RESULTS	Patient satisfaction results indicated greater satisfaction for telemedicine as opposed to traditional face-to-face treatment .
CONCLUSIONS	Findings reveal a trend expressing the equivalence of telemedicine and face-to-face therapy when treating OEF/OIF veterans with PTSD among rural populations by a community provider .
CONCLUSIONS	It further demonstrates the successful collaboration between a community healthcare provider and the military healthcare system .

###24448850
OBJECTIVE	To test the effects of a school-based prevention programme on students ' smoking-related behaviour , attitudes and knowledge 6 months after implementation over 2 school-years has ended .
METHODS	Two-arm prospective cluster randomised controlled trial with a follow-up survey 6 months after end of programme implementation , that is , 26 months after baseline .
METHODS	45 public secondary schools from four federal states in Germany ( Bremen , Hesse , North Rhine-Westphalia , Schleswig-Holstein ) .
METHODS	A total of 3444 students from 172 classes with a mean age of 10.37 years ( SD = 0.59 ) and 47.9 % girls at baseline .
METHODS	Analysis sample with follow-up up data merged to baseline data comprises 2513 datasets ( 73 % ) .
METHODS	` Eigenstndig werden 5 +6 ' , a school-based prevention programme for grades 5 and 6 to enhance substance-specific and general life skills , consisting of 14 units ( 90 min ) and two workshops ( 4-6 h ) being taught over a time period of 2 school-years by trained teachers .
METHODS	Lifetime and current smoking , incidence of smoking in baseline never smokers , smoking-related knowledge , attitudes , perceived norms of smoking and self-efficacy to refuse cigarette offers were assessed in students .
RESULTS	6 months after the end of programme implementation , students of intervention classes showed significantly lower rates for lifetime smoking ( adjusted OR = 0.63 ; 95 % CI 0.41 to 0.96 ; p = 0.026 ) and incidence of smoking ( adjusted OR = 0.66 ; 95 % CI 0.43 to 1.00 ; p = 0.047 ) , a higher increase of smoking-related knowledge ( adjusted = 9.38 ; 95 % CI 6.73 to 12.04 ; p < 0.001 ) and a greater change in attitudes towards a more critical perception of risks and disadvantages of smoking ( adjusted = 0.10 ; 95 % CI 0.03 to 0.16 ; p = 0.002 ) .
RESULTS	No group differences were found for current smoking , perceived norms of smoking and self-efficacy to refuse cigarette offers .
CONCLUSIONS	Participation in the school-based prevention programme ` Eigenstndig werden 5 +6 ' may have small effects on smoking behaviour and attitudes and a moderate effect on smoking-related knowledge .
BACKGROUND	Current Controlled Trials ISRCTN99442407 .

###25320597
BACKGROUND	Intrathecal morphine for caesarean delivery provides excellent postoperative analgesia but it is commonly associated with nausea and vomiting .
BACKGROUND	This prospective , randomized , double blind study was carried out to compare the effectiveness of a combination of dexamethasone and ondansetron with dexamethasone alone for prevention of postoperative nausea and vomiting ( PONV ) following intrathecal morphine injection for caesarean section .
METHODS	A total of 108 parturients aged 18-40 years for elective caesarean section were randomized into 2 groups ( n = 54 ) to receive either intravenous dexamethasone 8 mg ( Group A ) or a combination of intravenous dexamethasone 8 mg and ondansetron 4 mg ( group B ) .
METHODS	The study drug for each group consisted of 0.5 % hyperbaric bupivacaine and 0.2 mg morphine .
METHODS	The primary outcome variables were postoperative nausea and vomiting ( PONV ) which were assessed for a period of 24 hours .
METHODS	The patient 's vital signs were monitored and documented .
RESULTS	The incidence of nausea and vomiting was significantly reduced in patients who received a combination of dexamethasone and ondansetron compared with dexamethasone alone ( 9.3 % Vs 37 % , respectively , P = 0.003 ) .
CONCLUSIONS	This study showed that a combination of dexamethasone and ondansetron administered prophylactically significantly reduced the incidence of PONV in pregnant women on intrathecal morphine for caesarean section .

###25231130
OBJECTIVE	There is increasing evidence of Gleason score ( GS ) drift in prostatic core biopsies during the last two decades .
OBJECTIVE	The ProtecT study is a randomized controlled study and provides an excellent cohort to study the effect of time , prostate-specific antigen ( PSA ) level , perineural invasion , tumour length and age on GS .
RESULTS	The ProtecT study recruited men in the United Kingdom between 1999 and 2010 .
RESULTS	The Gleason scores were grouped into four categories 3 + 3 , 3 + 4 , 4 + 3 and 4 + 4 for analysis .
RESULTS	Data from England between 2000 and 2012 were also available .
RESULTS	A total of 3282 biopsies containing cancer were analysed .
RESULTS	For each year of the ProtecT study , the odds of being diagnosed with a higher GS category increased by 4.9 % .
RESULTS	Higher GS was also associated with perineural invasion , increasing tumour length , age and PSA level .
RESULTS	While biopsy GS from England was incomplete , it also showed a marked decrease in GS five and six tumours during the same period .
CONCLUSIONS	There was GS drift from 3 + 3 to 3 + 4 with time in the ProtecT study , but there appeared to be no significant change in percentage of GS 4 + 3 or higher .
CONCLUSIONS	This drift was less dramatic when compared to GS in the rest of England .

###24684977
OBJECTIVE	Sleep problems are common in children with attention-deficit/hyperactivity disorder ( ADHD ) , yet little is known about sleep medication use in this population .
OBJECTIVE	The aim of this study was to describe sleep medication use , as well as associated child and family characteristics in school-aged children with ADHD .
METHODS	Sleep medication use was ascertained using a prospective parent-completed seven-night sleep and medication log .
METHODS	Exposure variables included socio-demographic characteristics , total sleep problem severity ( Children 's Sleep Habits Questionnaire ) , ADHD severity and subtype ( ADHD Rating Scale IV ) , ADHD medication use , internalising and externalising co-morbidities ( Anxiety Disorders Interview Schedule for Children/Parent version IV ) and parent mental health ( Depression Anxiety Stress Scale ) .
RESULTS	Two hundred and fifty-seven children with ADHD participated and of these 57 ( 22 % ) were taking sleep medication ( melatonin 14 % and clonidine 9 % ) .
RESULTS	Sleep medication use was associated with combined-type ADHD and ADHD medication use .
RESULTS	The presence of co-occurring internalising and externalising co-morbidities was also associated with sleep medication use in ad hoc analyses .
CONCLUSIONS	Sleep medication use is common in children with ADHD and is associated with combined-type ADHD and use of ADHD medication .
CONCLUSIONS	Further research is needed on the broad functional benefits and long-term safety of sleep medication in this population .

###24708747
BACKGROUND	Despite policy interest , an ethical imperative , and evidence of the benefits of patient decision support tools , the adoption of shared decision making ( SDM ) in day-to-day clinical practice remains slow and is inhibited by barriers that include culture and attitudes ; resources and time pressures .
BACKGROUND	Patient decision support tools often require high levels of health and computer literacy .
BACKGROUND	Option Grids are one-page evidence-based summaries of the available condition-specific treatment options , listing patients ' frequently asked questions .
BACKGROUND	They are designed to be sufficiently brief and accessible enough to support a better dialogue between patients and clinicians during routine consultations .
BACKGROUND	This paper describes a study to assess whether an Option Grid for osteoarthritis of the knee ( OA of the knee ) facilitates SDM , and explores the use of Option Grids by patients disadvantaged by language or poor health literacy .
METHODS	This will be a stepped wedge exploratory trial involving 72 patients with OA of the knee referred from primary medical care to a specialist musculoskeletal service in Oldham .
METHODS	Six physiotherapists will sequentially join the trial and consult with six patients using usual care procedures .
METHODS	After a period of brief training in using the Option Grid , the same six physiotherapists will consult with six further patients using an Option Grid in the consultation .
METHODS	The primary outcome will be efficacy of the Option Grid in facilitating SDM as measured by observational scores using the OPTION scale .
METHODS	Comparisons will be made between patients who have received the Option Grid and those who received usual care .
METHODS	A Decision Quality Measure ( DQM ) will assess quality of decision making .
METHODS	The health literacy of patients will be measured using the REALM-R instrument .
METHODS	Consultations will be observed and audio-recorded .
METHODS	Interviews will be conducted with the physiotherapists , patients and any interpreters present to explore their views of using the Option Grid .
CONCLUSIONS	Option Grids offer a potential solution to the barriers to implementing traditional decision aids into routine clinical practice .
CONCLUSIONS	The study will assess whether Option Grids can facilitate SDM in day-to-day clinical practice and explore their use with patients disadvantaged by language or poor health literacy .
BACKGROUND	Current Controlled Trials ISRCTN94871417 .

###24933430
BACKGROUND	The ingestion of carbohydrate ( CHO ) before and during exercise and at halftime is commonly recommended to soccer players for maintaining blood glucose concentrations throughout match play .
BACKGROUND	However , an exercise-induced rebound glycemic response has been observed in the early stages of the second half of simulated soccer-specific exercise when CHO-electrolyte beverages were consumed regularly .
BACKGROUND	Therefore , the metabolic effects of CHO beverage consumption throughout soccer match play remain unclear .
OBJECTIVE	To investigate the blood glucose and blood lactate responses to CHOs ingested before and during soccer match play .
METHODS	Crossover study .
METHODS	Applied research study .
METHODS	Ten male outfield academy soccer players ( age = 15.6 0.2 years , height = 1.74 0.02 m , mass = 65.3 1.9 kg , estimated maximal oxygen consumption = 58.4 0.8 mLkg ( -1 ) min ( -1 ) ) .
METHODS	Players received a 6 % CHO-electrolyte solution or an electrolyte ( placebo ) solution 2 hours before kickoff , before each half ( within 10 minutes ) , and every 15 minutes throughout exercise .
METHODS	Blood samples were obtained at rest , every 15 minutes during the match ( first half : 0-15 , 15-30 , and 30-45 minutes ; second half : 45-60 , 60-75 , and 75-90 minutes ) and 10 minutes into the halftime break .
METHODS	Metabolic responses ( blood glucose and blood lactate concentrations ) and markers of exercise intensity ( heart rate ) were recorded .
RESULTS	Supplementation influenced the blood glucose response to exercise ( time treatment interaction effect : P .05 ) , such that glucose concentrations were higher at 30 to 45 minutes in the CHO than in the placebo condition .
RESULTS	However , in the second half , blood glucose concentrations were similar between conditions because of transient reductions from peak values occurring in both trials at halftime .
RESULTS	Blood lactate concentrations were elevated above those at rest in the first 15 minutes of exercise ( time-of-sample effect : P < .001 ) and remained elevated throughout exercise .
RESULTS	Supplementation did not influence the pattern of response ( time treatment interaction effect : P = .49 ) .
CONCLUSIONS	Ingestion of a 6 % CHO-electrolyte beverage before and during soccer match play did not benefit blood glucose concentrations throughout the second half of exercise .

###25171663
OBJECTIVE	The aim of this study was to compare the effectiveness in the medium term between low and high doses of triamcinolone hexacetonide used in intra-articular injection in medium-sized joints of rheumatoid arthritis ( RA ) patients .
METHODS	A randomized double-blind study was carried out in rheumatoid arthritis patients with wrist painful refractory synovitis .
METHODS	Sixty wrists were included and randomized to receive low dose ( 20 mg ) or high dose ( 40 mg ) .
METHODS	The outcomes assessed in T0 , T1 , T4 , T8 , and T12 weeks were visual analog scale for pain and for swelling , chronic disease activity index , goniometry , simplified Stanford Health Assessment Questionnaire , and side effects .
RESULTS	Baseline mean ( standard deviation ) values were pain visual analog scale of 6.1 ( 1.6 ) and 6.3 ( 1.7 ) , P = 0.562 ; swelling visual analog scale of 5.9 and 6.4 , P = 0.466 ; chronic disease activity index of 17.8 and 16.8 , P = 0.366 ; and Health Assessment Questionnaire of 0.8 and 0.7 , P = 0.238 , in the high - and low-dose groups , respectively .
RESULTS	Both groups improved pain and swelling assessed by the visual analog scale , P < 0.001 , in the intragroup analysis .
RESULTS	Chronic disease activity index , goniometry , and Health Assessment Questionnaire also improved equally over time in both groups in the intragroup analysis ( P < 0.001 , 0.001 , and 0.002 , respectively ) .
RESULTS	No serious side effects were detected .
CONCLUSIONS	High and low triamcinolone hexacetonide doses had good effectiveness in wrist-blinded intra-articular injection of rheumatoid arthritis patients , without statistical difference between them .

###24394594
OBJECTIVE	We assessed the impact of a noise-reduction program in a pediatric operating theatre .
BACKGROUND	Adverse effects from noise pollution in theatres have been demonstrated .
METHODS	In 156 operations spatially resolved , sound levels were measured before and after a noise-reduction program on the basis of education , rules , and technical devices ( Sound Ear ) .
METHODS	Surgical complications were recorded .
METHODS	The surgeon 's biometric ( saliva cortisol , electrodermal activity ) and behavioral stress responses ( questionnaires ) were measured and correlated with mission protocols and individual noise sensitivity .
RESULTS	Median noise levels in the control group versus the interventional group were reduced by -3 3 dB ( A ) ( 63 vs 59 dB ( A ) , P < 0.001 ) with a grossly decreased number of peaks greater than 70 dB ( A ) ( n = -61 / hour , P < 0.01 ) .
RESULTS	The intervention significantly reduced non-operation-related noise .
RESULTS	The incidence of postoperative complications was significantly lower in patients of the intervention group ( n = 10/56 vs 20/58 control ; P < 0.05 ) .
RESULTS	`` Responders , '' surgeons with an above-average noise sensitivity ( correlation r = -0.6 for the work subscale of the NoiseQ questionnaire , P < 0.05 ) , experienced improved intrateam communication , a decrease in disturbing conversations and sudden noise peaks ( P < 0.05 ) .
RESULTS	Biometrically , the intervention decreased both the surgeon 's pre - to postoperative rise in cortisol by approximately 20 % and the surgeon 's electrodermal potentials of greater than 15 S , indicating severe stress by 60 % ( P > 0.05 ) .
CONCLUSIONS	Spontaneous noise during pediatric operations attains the magnitude of a lawn mower and peaks resemble a passing truck .
CONCLUSIONS	The sound intensity could be reduced by 50 % by specific measures .
CONCLUSIONS	This reduction was associated with a significantly lowered number of postoperative complications .
CONCLUSIONS	The surgeon 's benefits are idiosyncratic with `` responders '' experiencing marked improvements .

###25135646
BACKGROUND	Asthma is a complex disease presenting with variable symptoms which are sometimes hard to control .
BACKGROUND	The purpose of the study was to describe the prevalence of asthma symptoms , use of asthma medications and allergic sensitization in subjects with asthma .
BACKGROUND	We also related those indices to the level of asthma control , lung function and in particular , cough .
METHODS	An extensive questionnaire was sent to randomly selected adults from the West Sweden region .
METHODS	Clinical examinations and interview were performed in a subset .
METHODS	Of the participants , 744 were defined as having an ongoing asthma - reported ever having asthma or physician diagnosed asthma and one of the following - use of asthma medications , recurrent wheeze or attacks of shortness of breath with or without wheeze in the last 12months .
METHODS	A respiratory disease-free control group of 847 subjects was also described .
RESULTS	According to GINA guidelines , 40.6 % of the asthmatics had partly controlled and 17.8 % had uncontrolled asthma .
RESULTS	Asthmatic subjects reported significantly more symptoms in the last 12months than the control group - wheezing ( 79.4 vs 9.2 % ) , shortness of breath ( 36.1 vs 2.5 % ) , wheezing with shortness of breath ( 58.7 vs 1.3 % ) .
RESULTS	Important complaints were morning cough ( 42.5 vs 15.5 % ) , cough with sputum production ( 36.1 vs 6.8 % ) and longstanding cough ( 32.5 vs 11.1 % ) , which bothered two thirds of the uncontrolled and one third of partly controlled subjects .
RESULTS	Asthma medications were used by 87.5 % of the asthmatics , although around 30 % of them who had insufficiently controlled disease used only short-acting beta-agonists .
RESULTS	Asthmatics also had lower lung function , reacted to lower doses of methacholine that the controls and 13.6 % of them had a FEV1/FVC ratio below 0.7 .
RESULTS	Allergic rhinitis was reported by 73.8 % of the asthmatics and they were more frequently sensitized to several common allergens .
CONCLUSIONS	Approximately 60 % of asthmatics from this population-based study had insufficiently controlled asthma and persistent complaints , despite a high use of asthma medications .
CONCLUSIONS	These self-reported symptoms were supported by clinical examination data .
CONCLUSIONS	Increased cough frequency is an indicator of a more severe and difficult to control disease and should be considered when asthma is characterized .

###26034004
BACKGROUND	Current heart failure ( HF ) risk prediction models do not consider how individual patient assessments occur in incremental steps ; furthermore , each additional diagnostic evaluation may add cost , complexity , and potential morbidity .
RESULTS	Using a cohort of well-treated ambulatory HF patients with reduced ejection fraction who had complete clinical , laboratory , health-related quality of life , imaging , and exercise testing data , we estimated incremental prognostic information provided by 5 assessment categories , performing an additional analysis on those with available N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) levels .
RESULTS	We compared the incremental value of each additional assessment ( quality of life screen , laboratory testing , echocardiography , and exercise testing ) to baseline clinical assessment for predicting clinical outcomes ( all-cause mortality , all-cause mortality/hospitalization , and cardiovascular death/HF hospitalizations ) , gauging incremental improvements in prognostic ability with more information using area under the curve and reclassification improvement ( net reclassification index ) , with and without NT-proBNP availability .
RESULTS	Of 2331 participants , 1631 patients had complete clinical data ; of these , 1023 had baseline NT-proBNP .
RESULTS	For prediction of all-cause mortality , models with incremental assessments sans NT-proBNP showed improvements in C-indices ( 0.72 [ clinical model alone ] -0.77 [ complete model ] ) .
RESULTS	Compared with baseline clinical assessment alone , net reclassification index improved from 0.035 ( w/laboratory data ) to 0.085 ( complete model ) .
RESULTS	These improvements were significantly attenuated for models in the subset with measured NT-proBNP data ( c-indices : 0.80 [ w/laboratory data ] -0.81 [ full model ] ) ; net reclassification index improvements were similarly marginal ( 0.0910.096 ) ; prediction of other clinical outcomes had similar findings .
CONCLUSIONS	In chronic HF patients with reduced ejection fraction , the marginal benefit of complex prognostic evaluations should be weighed against potential patient discomfort and cost escalation .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00047437 .

###24432669
OBJECTIVE	To evaluate the curative effect and safety of Bushen Qiangji Decoction ( BQD ) and Qingre Qiangji Decoction ( QQD ) in treating ankylosing spondylitis ( AS ) patients , and to verify the clinical utility of AS syndrome differentiation and treatment scheme [ Shen-deficiency induced stasis obstruction syndrome ( SDISOS ) and dampness-heat obstruction syndrome ( DHOS ) being two basic syndrome types , Shen invigorating blood activating method ( SIBAM ) and heat clearing dampness resolving method ( HCDRM ) being two basic treatment methods ] .
METHODS	Totally 354 AS patients of SDISOS and DHOS were randomly assigned to the treatment group and the control group using a multi-center randomized , positive drug parallel-controlled clinical trail .
METHODS	Patients in treatment group were treated by BQD or QQD according to syndrome typing , while those in the control group took Sulfasalazine enteric-coated tablet ( SECT ) , 24 weeks as one therapeutic course .
METHODS	After treatment , the clinical efficacy was evaluated by using ASAS20 standard ( set by Asessment in Ankylosing Spondylitis working group ) , Chinese medical efficacy evaluation standards , and BASDAI , BASFI , BASMI , night-pain index , spinal pain index , PGA , C-reactive protein ( CRP ) , and erythrocyte sedimentation rate ( ESR ) .
RESULTS	After 24 weeks of treatment by BQD or QQD , ASAS20 standard rate was 86.75 % in the treatment group , and the total effective rate of Chinese medical syndrome was 85.47 % .
RESULTS	They could significantly reduce patients ' integrals of Chinese medical syndrome , BASDAI , BASFI , BASMI , night-pain index , spinal pain index , and PGA ( all P < 0.01 ) .
CONCLUSIONS	QQD and BQD got confirmable clinical effects in treating AS , providing strong evidence of evidence-based medicine for syndrome differentiation and treatment of AS .

###24485947
OBJECTIVE	The diagnosis of incurable cancer may evoke physiological arousal in patients .
OBJECTIVE	Physiological arousal can negatively impact patients ' recall of information provided in the medical consultation .
OBJECTIVE	We aim to investigate whether clinicians ' affective communication during a bad news consultation will decrease patients ' physiological arousal and will improve recall .
METHODS	Healthy women ( N = 50 ) , acting as analogue patients , were randomly assigned to watch one out of the two versions of a scripted video-vignette of a bad news consultation in which clinician 's communication differed : standard vs. affective communication .
METHODS	Participants ' skin conductance levels were obtained during video-watching , and afterwards their recall was assessed .
RESULTS	While the diagnosis increased skin conductance levels in all analogue patients , skin conductance levels during the remainder of the consultation decreased more in the affective communication condition than in the standard condition .
RESULTS	Analogue patients ' recall was significantly higher in the affective condition .
CONCLUSIONS	Breaking bad news evokes physiological arousal .
CONCLUSIONS	Affective communication can decrease this evoked physiological arousal and might be partly responsible for analogue patients ' enhanced information recall .
CONCLUSIONS	Although our findings need to be translated to clinical patients , they suggest that clinicians need to deal with patients ' emotions before providing additional medical information .

###25252514
OBJECTIVE	To compare the efficacy of British Thoracic Society and American Thoracic Society guidelines for reintroduction of anti-tuberculous therapy after drug-induced liver injury , and to assess the ease of administration of each guideline on a scale of 1-10 .
METHODS	The randomised prospective interventional study was conducted at the Department of Medicine and Pulmonology , Dow University of Health Sciences , Karachi , from December 2011 to November 2013 .
METHODS	Patients with anti-tuberculous therapy drug-induced liver injury were selected .
METHODS	Hepatotoxic anti-tuberculous therapy was stopped and modified anti-tuberculous therapy was started .
METHODS	Patients were followed weekly till clinical and biochemical parameters got stabilised .
METHODS	After stabilisation , the patients were randomised to one of the two groups to receive re-introduction of anti-tuberculous therapy under the guidelines of British Thoracic Society ( Group I ) or those of American Thoracic Society ( Group II ) .
METHODS	Means of the groups were analysed by Student 's t test and proportions were compared by chi-square test .
METHODS	Multivariate analysis was done for age , body mass index and serum albumin for recurrence of drug-induced liver injury after the re-introduction .
METHODS	P value < 0.05 was taken as significant .
RESULTS	Of the total 325 patients , 163 ( 50.15 % ) were in Group I , while 162 ( 49.84 % ) were in Group II .
RESULTS	The frequency of recurrence of drug-induced liver injury in Group I was 16 ( 9.8 % ) and in Group II it was 18 ( 11.1 % ) .
RESULTS	There was no statistically significant difference between the two groups ( p < 0.7 ) .
RESULTS	Age was positively related with drug-induced liver injury , while body mass index and serum albumin were negatively associated .
CONCLUSIONS	There was no significant difference between the two major guidelines though the American Thoracic Society guideline was easier to follow .

###24332466
BACKGROUND	Although the use of a dynamic hip screw ( DHS ) is considered to be the preferred treatment for intertrochanteric fractures , the external fixation device could produce clinical outcomes comparable to the outcomes obtained with conventional treatment .
BACKGROUND	Furthermore , because external fixation is minimally invasive , we expected a lower rate of morbidity .
BACKGROUND	Therefore , we compared the two treatments in a clinical trial of elderly patients with intertrochanteric fracture .
METHODS	60 elderly high-risk patients with an average age of 78 years were treated for intertrochanteric fracture , resulting from a low energy trauma .
METHODS	Patients were randomly divided in two groups regarding to treatment .
METHODS	In Group A the patients were treated with DHS , while in Group B were treated with external fixator .
RESULTS	The fixator was well accepted and no patient had significant difficulties while sitting or lying .
RESULTS	The average intraoperative time was 73 min in Group A and 15 min in Group B ( p < 0.05 ) .
RESULTS	27 patients of Group A need blood transfusion postoperatively and none in Group B ( p < 0.05 ) .
RESULTS	The mean duration of hospitalization in Group A and Group B was 8.4 and 2.2 days , respectively ( p < 0.05 ) .
RESULTS	9 of patients Group B had pin-track infection grade 2 that all were treated by oral antibiotics .
RESULTS	There were no differences in comorbidities , quality of reduction , screw cut out , bed sore and HHS between the two groups .
CONCLUSIONS	Treatment with external fixator is an effective treatment for intertrochanteric fractures in elderly highrisk patients .
CONCLUSIONS	The advantages include quick and simple application , minimal blood loss , less radiation exposure , adequate fixation , pain reduction , early discharge from hospital , low costs and favourable functional outcomes .

###24732867
OBJECTIVE	Constipation is often characterized by slow colonic transit , but the relationship between colonic transit time ( CTT ) and symptoms is unclear .
OBJECTIVE	The aims of this study were to investigate the effect of prucalopride , a 5-hydroxytryptamine receptor-4 agonist , on CTT and assess the relationship between CTT and symptoms .
METHODS	This was an integrated analysis of three randomized , placebo-controlled , phase 2 dose-finding trials of prucalopride in patients with chronic constipation ( ClinicalTrials.gov identifiers : NCT00617513 ; NCT00631813 ; and NCT00596596 ) .
METHODS	Measurements of CTT were analyzed using radio-opaque markers at the start and end ( 4 or 12 weeks ) of treatment .
METHODS	At these visits , patients assessed the presence and severity of their symptoms .
RESULTS	In total , 280 patients had CTT measurements before and at the end of treatment and were included in the analysis .
RESULTS	Their mean age was 43 years , 93 % were women , and mean duration of constipation was 19 years .
RESULTS	After a once daily treatment with prucalopride 2 mg ( n = 98 ) and 4 mg ( n = 70 ) , CTT was reduced by 12.0 h ( 95 % confidence interval ( CI ) : -18.9 , -5.1 ) and 13.9 h ( 95 % CI : -20.5 , -7.4 ) , respectively ; CTT increased by 0.5 h ( 95 % CI : -4.5 , 5.5 ) with placebo ( n = 112 ) .
RESULTS	At the end of the trial , symptoms including bloating/flatulence/distension and straining were rated as severe or very severe by a higher proportion of patients with slow or very slow CTT ( > 48 h ) than by those with normal CTT .
CONCLUSIONS	There was a clear relationship between increased CTT and increased symptom severity in patients with chronic constipation .
CONCLUSIONS	Treatment with prucalopride accelerated CTT in these individuals .

###24925675
BACKGROUND	Despite considerable use of make your own ( MYO ) cigarettes worldwide and increasing use in the United States , relatively little is known about how these cigarettes are smoked and the resultant toxicant exposure .
METHODS	In a laboratory study , we compared two types of MYO cigarettes-roll your own ( RYO ) and personal machine made ( PMM ) - with factory-made ( FM ) cigarettes in three groups of smokers who exclusively used RYO ( n = 34 ) , PMM ( n = 23 ) , or FM ( n = 20 ) .
METHODS	Within each group , cigarettes were smoked in three conditions : ( i ) after confirmed overnight tobacco abstinence ; ( ii ) in an intense smoking paradigm ; and ( iii ) without restrictions .
METHODS	All cigarettes were smoked ad lib through a smoking topography unit .
RESULTS	Plasma nicotine significantly increased after cigarettes in all conditions except PMM in the intense smoking paradigm .
RESULTS	Puff volume , puff duration , total puff volume , and puff velocity did not differ between cigarette types but the puffs per cigarette and time to smoke were significantly smaller for RYO compared with PMM and FM .
RESULTS	Regardless of the cigarette , participants consumed the first three puffs more vigorously than the last three puffs .
CONCLUSIONS	Despite the belief of many of their consumers , smoking MYO cigarettes is not a safe alternative to FM cigarettes .
CONCLUSIONS	Like FM , MYO cigarettes expose their users to harmful constituents of tobacco smoke .
CONCLUSIONS	Despite differences in size and design their puffing profiles are remarkably similar .
CONCLUSIONS	These data are relevant to health and regulatory considerations on the MYO cigarettes .

###24495355
BACKGROUND	Declining cognitive function is relatively common and increasingly prevalent .
BACKGROUND	Studies have shown that different nutrients ( e.g. , Ginkgo biloba and vitamin E ) appear to be effective at improving memory and concentration , while less is known about their effect on immunity .
METHODS	This study investigated the effect of Ginkgo Synergy ( ) plus Choline ( n = 33 ) and OPC Synergy ( ) plus Catalyn ( ) ( n = 31 ) versus placebo ( n = 33 ) in a 6-month , randomized , double-blind trial on cognitive and immune functioning among English-speaking , non-smoking , healthy older adults .
METHODS	The Stroop Color and Word Test , Trail Making Test A and B , Controlled Oral Word Association , Hopkins Verbal Learning , Mini-Mental State Exam , and Digit Symbol were administered at baseline and 3 and 6 months follow-up to assess cognitive functioning .
METHODS	Cytokines and growth factors were measured at baseline and 6 months to assess inflammation and immune functioning .
METHODS	Data were analyzed with linear mixed modeling .
RESULTS	No serious adverse events were noted in this study .
RESULTS	According to time on the Trail Making Test-B , the Ginkgo Synergy ( ) plus Choline arm showed improvement from baseline to 3 months follow-up ( mean difference = 24.2 ; SE = 6.4 ; 95 % CI : 8.6 , 39.7 ; p = 0.01 ) .
RESULTS	On the Controlled Oral Word Association Trial-S , the scores significantly increased for the Ginkgo Synergy ( ) plus Choline arm from baseline to 6 months follow-up ( mean difference = 2.1 ; SE = 0.8 ; 95 % CI : 0.2 , 3.9 ; p < 0.05 ) and for the OPC Synergy ( ) plus Catalyn ( ) arm from baseline to 3 months follow-up ( mean difference = 2.1 ; SE = 0.8 ; 95 % CI : 0.2 , 4.0 ; p < 0.05 ) .
RESULTS	Epidermal growth factor significantly decreased from baseline to 6 months follow-up for the Ginkgo Synergy ( ) plus Choline arm ( mean difference = 120.7 ; SE = 28.4 ; 95 % CI : 62.6 , 178.8 ; p < 0.001 ) .
CONCLUSIONS	Our study showed isolated and modest effects of a Ginkgo biloba plus choline-based formula on cognitive and immune functioning among healthy older adults with no history of significant cognitive deficits .
CONCLUSIONS	Our trial was registered with clinicaltrials.gov ( ID : NCT01672359 ) .
CONCLUSIONS	This study was supported by a grant from Standard Process , Inc. .

###25163993
OBJECTIVE	This study concerns the influence of an improvement of body contact on regulatory disorders in infancy .
OBJECTIVE	Two interventions were examined : 1 .
OBJECTIVE	parent counseling on the subject of body contact ; 2 .
OBJECTIVE	practical training of body contact in connection with exposure .
OBJECTIVE	Both methods were supplemented by a video-based parent training .
METHODS	20 infants with regulatory disorder were assigned to each treatment .
METHODS	Body and eye contact were examined by means of video ratings before and after treatment .
METHODS	In addition , we measured the daily amount of crying , sleeping , feeding , being fussy , and quiet play by means of an infant behavior diary .
RESULTS	Both interventions resulted in an improvement of body contact , though only in the group with practical training was this improvement stable after 3 months .
RESULTS	Taking all 40 participating infants together , we found significant improvements for `` fussiness , '' `` sleep duration , '' `` awake , quiet or playing , '' and a marginal significant intervention effect for the duration of crying .
RESULTS	Both interventions showed that children who had markedly improved in body contact also improved with regard to the regulation problem .
RESULTS	Finally , the practical training of body contact was superior to pure counseling respective to the fussiness of the infants and to their gaze contact .
CONCLUSIONS	Body contact can be improved through specific therapeutic interventions .
CONCLUSIONS	Video-based parent training in combination with interventions aiming at an improvement of body contact have a positive effect on the regulation problem .

###25205201
OBJECTIVE	To evaluate the eradication rates , side effects and the patient compliance of a dual therapy with rabeprazole and amoxicillin as the first-line therapy in patients with Helicobacter pylori ( H. pylori ) infection .
METHODS	A total of 120 patients diagnosed endoscopically with non-ulcer dyspepsia with H. pylori infection were randomly assigned into two groups , one treated with amoxicillin 1 g thrice daily plus rabeprazole 10 mg twice daily ( R10A group ) or 20 mg twice daily ( R20A group ) for 14 days .
METHODS	H. pylori eradication was evaluated by ( 13 ) C-urea breath test ( UBT ) at 4-6 weeks after the completion of treatment .
METHODS	H. pylori eradication rate was analyzed by per-protocol ( PP ) and intention-to-treat ( ITT ) analyses together with 95 % confidence interval ( CI ) .
METHODS	Side effects and patients ' compliance were also recorded .
RESULTS	Overall , 117 patients ( 58 in the R10A group and 59 in the R20A group ) completed the study , among whom five did not undertake the UBT .
RESULTS	H. pylori eradication was achieved in 89.8 % of patients in the R20A group by ITT analysis and 93.0 % by PP analysis , which was significantly higher than those in the R10A group ( 75.9 % and 80.0 % , respectively , P < 0.05 ) .
RESULTS	Side effects , including skin rash , abdominal discomfort , headache , insomnia and nausea , were all mild and were treated symptomatically without the need to discontinue the treatment .
CONCLUSIONS	The modified dual therapy with high doses of rabeprazole and amoxicillin is considered an effective and safe primary therapy for H. pylori eradication and could be recommended as the first-line eradication regimen for certain patients .

###25257804
BACKGROUND	Advanced cancer patients experience considerable symptoms , problems , and needs .
BACKGROUND	Early referral of these patients to specialized palliative care ( SPC ) could offer improvements .
BACKGROUND	The Danish Palliative Care Trial ( DanPaCT ) investigates whether patients with metastatic cancer will benefit from being referred to ` early SPC ' .
BACKGROUND	DanPaCT is a multicenter , parallel-group , superiority clinical trial with 1:1 randomization .
BACKGROUND	The planned sample size was 300 patients .
BACKGROUND	The primary data collection for DanPaCT is finished .
BACKGROUND	To prevent outcome reporting bias , selective reporting , and data-driven results , we present a detailed statistical analysis plan ( SAP ) for DanPaCT here .
RESULTS	This SAP provides detailed descriptions of the statistical analyses of the primary and secondary outcomes in DanPaCT .
RESULTS	The primary outcome is the change in the patient 's ` primary need ' .
RESULTS	The ` primary need ' is a patient-individualised outcome representing the score of the symptom or problem that had the highest intensity out of seven at baseline assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire ( EORTC QLQ-C30 ) .
RESULTS	Secondary outcomes are the seven scales that are represented in the primary outcome , but each scale evaluated individually for all patients , and survival .
RESULTS	The detailed description includes chosen significance levels , models for multiple imputations , sensitivity analyses and blinding .
RESULTS	In addition , we discuss the patient-individualized primary outcome , blinding , missing data , multiplicity and the risk of bias .
CONCLUSIONS	Only few trials have investigated the effects of SPC. To our knowledge DanPaCT is the first trial to investigate screening based ` early SPC ' for patients with metastatic cancer from a broad spectrum of cancer diagnosis .
BACKGROUND	Clinicaltrials.gov identifier : NCT01348048 ( May 2011 ) .

###25322078
BACKGROUND	Chronic obstructive pulmonary disease ( COPD ) is a costly long-term condition associated with frequent Accident and Emergency ( A&E ) and hospital admissions .
BACKGROUND	Psychological difficulties and inadequate self-management can amplify this picture .
OBJECTIVE	To compare a cognitive-behavioural manual versus information booklets ( IB ) on health service use , mood and health status .
METHODS	Two hundred and twenty-two COPD patients were randomly allocated to receive either the COPD breathlessness manual ( CM ) or IB .
METHODS	They were instructed to work through their programme at home , over 5 weeks .
METHODS	Guidance from a facilitator was provided at an initial home visit plus two telephone call follow-ups .
RESULTS	After 12 months , total A&E visits had reduced by 42 % in the CM group , compared with a 16 % rise in the IB group .
RESULTS	The odds of people in the IB group attending A&E 12 months post-intervention was 1.9 times higher than for the CM group ( CI 1.05-3 .53 ) .
RESULTS	Reduction in hospital admissions and bed days were greatest in the CM group .
RESULTS	At 6 months , there were significantly greater improvements in anxiety ( F ( 2,198 ) = 5.612 , P = 0.004 ) , depression ( F ( 1.8,176.1 ) = 10.697 , P0 .001 ) and dyspnoea ( F ( 2,198 ) = 18.170 , P0 .001 ) in the CM group .
RESULTS	Estimated savings at 12 months were greatest in the CM group , amounting to 30k or 270 per participant .
CONCLUSIONS	The COPD manual , which addresses physical and mental health , is a straightforward cost-effective intervention that is worth offering to COPD patients within primary or secondary care .

###25350960
OBJECTIVE	To describe baseline and emergent HIV-1 resistance to elvitegravir / cobicistat/emtricitabine/tenofovir DF ( EVG/COBI/FTC / TDF ) and ritonavir-boosted atazanavir/emtricitabine/tenofovir DF ( ATV+RTV+FTC / TDF ) in HIV-1-infected , treatment-nave subjects through 144 weeks .
METHODS	This was a randomized , double-blind , phase 3 study .
METHODS	HIV-1 protease ( PR ) and reverse transcriptase ( RT ) were sequenced at screening .
METHODS	Genotypic and phenotypic analyses were performed at virologic failure confirmation and retrospectively at baseline for PR , RT , and integrase ( IN ) for patients with virologic failure through week 144 .
RESULTS	In the EVG / COBI/FTC/TDF group through week 144 , HIV-1 from 8 patients ( 2.3 % ; 8/353 treated patients ) developed primary IN strand transfer inhibitor ( INSTI ) ( n = 6 ) and/or nucleoside RT inhibitor ( NRTI ) resistance substitutions ( n = 7 ) .
RESULTS	The emergence of resistance decreased after the first year , with 5 patients developing HIV-1 resistance through week 48 , 1 from weeks 48-96 , and 2 from weeks 96-144 .
RESULTS	Emergent substitutions were E92Q , N155H , or Q148R ( n = 2 each ) and T66I or T97A ( n = 1 each ) in IN and M184V/I ( n = 7 ) and K65R ( n = 1 ) in RT. .
RESULTS	All 8 isolates had reduced susceptibility to EVG , FTC , or TDF .
RESULTS	Virus with EVG phenotypic resistance showed cross-resistance to raltegravir .
RESULTS	In the ATV+RTV+FTC / TDF group , HIV-1 from 2 patients ( 0.6 % ; 2/355 treated patients ; both at week 144 ) developed the resistance substitution M184V/I in RT. .
CONCLUSIONS	Resistance development to EVG/COBI/FTC / TDF was infrequent ( 2.3 % ) through 144 weeks of therapy and decreased over time , consistent with durable efficacy .

###24768120
BACKGROUND	Deep brain stimulation ( DBS ) is an effective and approved therapy for advanced Parkinson 's disease ( PD ) , and a recent study suggests efficacy in mid-stage disease .
BACKGROUND	This manuscript reports the results of a pilot trial investigating preliminary safety and tolerability of DBS in early PD .
METHODS	Thirty subjects with idiopathic PD ( Hoehn & Yahr Stage II off medication ) , age 50-75 , on medication 6 months but 4 years , and without motor fluctuations or dyskinesias were randomized to optimal drug therapy ( ODT ) ( n = 15 ) or DBS + ODT ( n = 15 ) .
METHODS	Co-primary endpoints were the time to reach a 4-point worsening from baseline in the UPDRS-III off therapy and the change in levodopa equivalent daily dose from baseline to 24 months .
RESULTS	As hypothesized , the mean UPDRS total and part III scores were not significantly different on or off therapy at 24 months .
RESULTS	Medication requirements in the DBS + ODT group were lower at all time points with a maximal difference at 18 months .
RESULTS	With a few exceptions , differences in neuropsychological functioning were not significant .
RESULTS	Two subjects in the DBS + ODT group suffered serious adverse events ; remaining adverse events were mild or transient .
CONCLUSIONS	This study demonstrates that subjects with early stage PD will enroll in and complete trials testing invasive therapies and provides preliminary evidence that DBS is well tolerated in early PD .
CONCLUSIONS	The results of this trial provide the data necessary to design a large , phase III , double-blind , multicenter trial investigating the safety and efficacy of DBS in early PD .

###25059544
BACKGROUND	The Grip on Challenging Behavior care program for managing challenging behavior was implemented in the dementia special care units of 17 Dutch nursing homes .
BACKGROUND	A process evaluation of the implementation of the care program was performed to determine the quality of the implementation and the lessons to be learned for future implementation .
METHODS	The care program was implemented according to a stepped wedge design .
METHODS	First-order data ( data on recruitment , reach , relevance and feasibility ) were used to determine the validity of the study , and second-order data ( intervention quality and the barriers and facilitators for implementing the care program ) were used to describe the implementation process .
METHODS	Two structured questionnaires were administered to care staff and key stakeholders and semi-structured interviews were held in the units .
RESULTS	University affiliated and non-affiliated nursing homes from different parts of the Netherlands participated .
RESULTS	The resident participation rate was over 95 % and the participation rate for the training sessions was 82 % .
RESULTS	Respondents considered the care program relevant and feasible .
RESULTS	The degree of implementation was not optimal .
RESULTS	The barriers and facilitators in implementing the care program could be divided into three categories : organizational aspects , culture on the unit and aspects of the care program itself .
CONCLUSIONS	The recruitment , reach , relevance and feasibility are sufficient to allow for analysis and generalization of the effects of the care program , but the degree of implementation should be taken into account in further analysis .
CONCLUSIONS	Future projects that involve implementation should consider the specific features of the organization and the cultural orientation of the unit to better adapt to specific needs .
BACKGROUND	The Netherlands National Trial register under number NTR2141 registered on 11 December 2009 .
BACKGROUND	Randomization took place in November 2010 , and the first intervention group started using the intervention in February 2011 .

###25144598
BACKGROUND	Cooling the body before exercise ( precooling ) has been studied as an ergogenic aid for many thermal conditions ; however , airflow accompanying exercise is seldom reported .
OBJECTIVE	To determine whether the physiologic and ergogenic benefits of precooling before endurance exercise may be negated with semirealistic airflow in hot conditions .
METHODS	Crossover study .
METHODS	Climate-controlled chamber in a research laboratory .
METHODS	Ten fit , healthy cyclists .
METHODS	After a familiarization trial , participants completed 4 randomized , counterbalanced sessions consisting of no precooling versus precooling and no fan airflow versus airflow ( ~ 4.8 m/s ) during exercise .
METHODS	Precooling was via chest-deep immersion ( ~ 24 C ) for 1 hour or until core temperature dropped 0.5 C. Participants then cycled at 95 % ventilatory threshold in a hot environment ( temperature = 30 C , relative humidity = 50 % ) until volitional exhaustion , core temperature reached > 39.5 C , or heart rate reached > 95 % of maximum .
METHODS	Thermal strain was assessed via core temperature ( esophageal and rectal thermistors ) and mean skin temperature ( thermistors at 10 sites ) and cardiovascular strain via heart rate and ratings of perceived exertion .
RESULTS	Endurance time ( 28 12 minutes without precooling or airflow ) increased by 30 23 minutes with airflow ( ~ 109 % ; 95 % confidence interval = 12 , 45 minutes ; P < .001 ) and by 16 15 minutes with precooling ( ~ 61 % ; 95 % confidence interval = 4 , 25 minutes ; P = .013 ) , but it was not further extended when the strategies were combined ( 29 21 minutes longer than control ) .
RESULTS	During cycling without precooling or airflow , mean core and skin temperatures were higher than in all other trials .
RESULTS	Precooling reduced heart rate by 7-11 beats/min during the first 5 minutes of exercise , but this attenuation ended by 15 minutes .
CONCLUSIONS	Most laboratory-based precooling studies have ( inadvertently ) overestimated the extent of the physiologic and ergogenic benefits for typical athlete-endurance situations .
CONCLUSIONS	Precooling increases work capacity effectively when airflow is restricted but may have little or no benefit when airflow is present .

###24606627
OBJECTIVE	Currently , a ` pedagogical gap ' exists in distributed medical education in that distance educators teach medical students but typically do not have the opportunity to assess them in large-scale examinations such as the objective structured clinical examination ( OSCE ) .
OBJECTIVE	We developed a remote examiner OSCE ( reOSCE ) that was integrated into a traditional OSCE to establish whether remote examination technology may be used to bridge this gap .
OBJECTIVE	The purpose of this study was to explore whether remote physician-examiners can replace on-site physician-examiners in an OSCE , and to determine the feasibility of this new examination method .
METHODS	Forty Year 3 medical students were randomised into six reOSCE stations that were incorporated into two tracks of a 10-station traditional OSCE .
METHODS	For the reOSCE stations , student performance was assessed by both a local examiner ( LE ) in the room and a remote examiner ( RE ) who viewed the OSCE encounters from a distance .
METHODS	The primary endpoint was the correlation of scores between LEs and REs across all reOSCE stations .
METHODS	The secondary endpoint was a post-OSCE survey of both REs and students .
RESULTS	Statistically significant correlations were found between LE and RE checklist scores for history taking ( r = 0.64-r = 0.80 ) , physical examination ( r = 0.41-r = 0.54 ) , and management stations ( r = 0.78 ) .
RESULTS	Correlations between LE and RE global ratings were more varied ( r = 0.21-r = 0.77 ) .
RESULTS	Correlations on three of the six stations reached significance .
RESULTS	Qualitative analysis of feedback from REs and students showed high acceptance of the reOSCE despite technological issues .
CONCLUSIONS	This preliminary study demonstrated that OSCE ratings by LEs and REs were reasonably comparable when using checklists .
CONCLUSIONS	Remote examination may be a feasible and acceptable way of assessing students ' clinical skills , but further validity evidence will be required before it can be recommended for use in high-stakes examinations .

###24754070
OBJECTIVE	To evaluate the anti-ischemic and anti-anginal efficacy of meldonium ( Idrinol ) in its short-term use as part of combination therapy in patients with chronic heart failure in the early post-infarction period .
METHODS	The investigation enrolled 60 patients ( men and women ) aged 45 to 75 years at weeks 3-4 after postmyocardial infarction with symptoms of Functional Class II-III heart failure .
METHODS	All the patients underwent physical examination , 24-hour ECG monitoring , heart rate variability ( HRV ) study , and quality of life assessment using the Seattle questionnaire .
METHODS	After randomization of the patients into 2 groups , Group 1 ( a study group ) ( n = 30 ) was given intravenous Idrinol 1000 mg/day in addition to the basic therapy of coronary heart disease .
METHODS	The study and control ( Group 2 ; n = 30 ) groups were matched for age , gender , disease severity , and basic therapy pattern .
RESULTS	Following 10-14 days of treatment , both groups showed clinical improvement and the autonomically normalizing effect of meldonium ( Idrinol ) , which were more pronounced in Group 1 patients .
CONCLUSIONS	Meldonium ( Idrinol ) was effective when parenterally administered in a dose of 1000 mg/day for 10-14 days as part of combination therapy in the early post-infarction period , which showed up as clinical improvement , a significant reduction in the frequency of angina attacks and in the need to use nitroglycerin , a decrease in the number of arrhythmia episodes , and its normalizing effect of HRV .

###24440666
OBJECTIVE	In some emergency situations resuscitation and ventilation may have to be performed by basic life support trained personnel , especially in rural areas where arrival of advanced life support teams can be delayed .
OBJECTIVE	The use of advanced airway devices such as endotracheal intubation has been deemphasized for basically-trained personnel , but it is unclear whether supraglottic airway devices are advisable over traditional mask-ventilation .
METHODS	In this prospective , randomized clinical single-centre trial we compared airway management and ventilation performed by nurses using facemask , laryngeal mask Supreme ( LMA-S ) and laryngeal tube suction-disposable ( LTS-D ) .
METHODS	Basic life support trained nurses ( n = 20 ) received one-hour practical training with each device .
METHODS	ASA 1-2 patients scheduled for elective surgery were included ( n = 150 ) .
METHODS	After induction of anaesthesia and neuromuscular block nurses had two 90-second attempts to manage the airway and ventilate the patient with volume-controlled ventilation .
RESULTS	Ventilation failed in 34 % of patients with facemask , 2 % with LMA-S and 22 % with LTS-D ( P < 0.001 ) .
RESULTS	In patients who could be ventilated successfully mean tidal volume was 240210 ml with facemask , 470120 ml with LMA-S and 470140 ml with LTS-D ( P < 0.001 ) .
RESULTS	Leak pressure was lower with LMA-S ( 23.310.8 cm H2O , 95 % CI 20.2-26 .4 ) than with LTS-D ( 28.913.9 cmH2O , 95 % CI 24.4-33 .4 ; P = 0.047 ) .
CONCLUSIONS	After one hour of introductory training , nurses were able to use LMA-S more effectively than facemask and LTS-D .
CONCLUSIONS	High ventilation failure rates with facemask and LTS-D may indicate that additional training is required to perform airway management adequately with these devices .
CONCLUSIONS	High-level trials are needed to confirm these results in cardiac arrest patients .

###25353053
BACKGROUND	Tadalafil ( TAD ) 5mg coadministered with finasteride ( FIN ) 5mg significantly improves lower urinary tract symptoms ( LUTS ) in men with benign prostatic hyperplasia ( BPH ) and prostatic enlargement .
BACKGROUND	However , its effects on erectile/sexual function have yet to be fully described .
OBJECTIVE	Assess the effects of TAD/FIN coadministration ( compared with placebo [ PBO ] / FIN ) on erectile and sexual function in sexually active men with LUTS and prostatic enlargement secondary to BPH with or without baseline comorbid erectile dysfunction ( ED ) .
METHODS	A randomized , double-blind , PBO-controlled study of 695 men ( 610 sexually active ; 450 with baseline ED ; 404 sexually active with baseline ED ) conducted at 70 sites in 13 countries .
METHODS	TAD 5mg or PBO once daily coadministered with FIN 5mg once daily for 26 weeks .
METHODS	International Index of Erectile Function ( IIEF ) domain and single-item scores ; proportions of patients who demonstrated minimal clinically important differences ( MCIDs ) in IIEF-Erectile Function domain scores ( IIEF-EF ; MCID defined as 4-point improvement ) ; and sexual dysfunction adverse events ( AEs ) .
RESULTS	Compared with PBO/FIN , TAD/FIN resulted in improvements for all IIEF domain and single-item scores assessed among patients with baseline ED ( P0 .002 for all measures ) and among patients without baseline ED ( P0 .041 for all measures ) .
RESULTS	Compared with PBO/FIN , significantly larger percentages of sexually active men with baseline ED treated with TAD/FIN achieved an IIEF-EF MCID after 4 , 12 , and 26 weeks of therapy ( P < 0.001 for odds ratio comparisons between TAD/FIN and PBO/FIN at all 3 three postbaseline timepoints ) .
RESULTS	The incidence of sexual AEs was low : five TAD/FIN patients and seven PBO/FIN patients reported sexual AEs , including ED , decreased/lost libido , and ejaculation disorders .
CONCLUSIONS	TAD/FIN coadministration for the treatment of men with LUTS and prostatic enlargement secondary to BPH concurrently leads to statistically significant improvements in erectile/sexual function and is well-tolerated , regardless of the presence/absence of ED at treatment initiation .

###25052361
BACKGROUND	Limited data exist regarding baseline characteristics and management of heart failure with reduced ejection fraction ( EF ) in tertiary care facilities .
METHODS	EVITA-HF comprises web-based case report data on demography , comorbidities , diagnostic and therapy measures , quality of life , adverse events and 1-year follow-up of patients hospitalized for chronic heart failure and an ejection fraction of less than 40 % .
RESULTS	Between February 2009 and June 2011 , a total of 1,853 consecutive , hospitalized patients ( pts ) were included in 16 centers in Germany .
RESULTS	Mean age was 70 years , 76 % were male .
RESULTS	Median EF was 30 % , and 63 % were in NYHA III/IV .
RESULTS	Ischemic cardiomyopathy was present in 56 % , history of hypertension in 76 % , diabetes in 39 % , impaired renal function in 33 % , thyroid dysfunction in 12 % , and malignoma in 7 % .
RESULTS	Sixty-eight percent of pts had a non-elective admission .
RESULTS	Rhythm was sinus/atrial fibrillation or flutter/pacemaker in 64 , 28 and 11 % , respectively .
RESULTS	Median heart rate amounted to 80 bpm , median blood pressure to 122/74 mmHg .
RESULTS	LBBB was present in 26 % of non-pacemaker pts .
RESULTS	Eighteen percent had an ICD or CRT-D .
RESULTS	Medication ( admission vs. discharge ) consisted of ACEI or ARB in 73 vs. 88 % , - blocker in 71 vs. 89 % , mineral corticosteroid receptor antagonist ( MRA ) in 32 vs. 57 % , diuretics in 68 vs. 83 % ( p < 0.001 for each ) .
RESULTS	Forty-two percent of pts received a specific treatment procedure beyond pharmacotherapy , of these 48 % revascularization , 39 % device therapy , 14 % electrical cardioversion , 5 % ablation procedures , 9 % valvular procedures , 6 % iv inotropes , 1.8 % IABP or LVAD implantation .
RESULTS	At discharge , 33 % of survivors had ICD - or CRT-D implants .
RESULTS	One-year mortality amounted to 16.8 % , and death or rehospitalization to 56 % .
RESULTS	NYHA class III/IV was found in 30 % ( p < 0.001 vs. index admission ) , general health status was improved in 45 % and unchanged in 36 % of patients .
RESULTS	Eighty-five percent of pts took ACEI or ARB , 86 % - blockers , 47 % MRA , and 78 % diuretics ( p < 0.001 vs. index discharge for all ) .
CONCLUSIONS	Patients with chronic heart failure and low ejection fraction represent an elderly and multimorbid population .
CONCLUSIONS	While hospitalized , they experience a significant optimization of prognosis-relevant medication , revascularization and device therapy .
CONCLUSIONS	After 1 year , mortality is moderate ; drug adherence is high and NYHA status favourable .
CONCLUSIONS	The EVITA-HF registry is able to reflect coherently the real-world management , efforts and follow-up in heart failure pts managed in tertiary care facilities .

###26055847
OBJECTIVE	To explore the relationship between prenatal hemoglobin ( Hb ) concentration and infant cognitive and motor functions .
METHODS	Our prospective cohort study included 1-year-old children born to women enrolled at their first antenatal care ( ANC ) visit in Allada , Benin , before 29 weeks of pregnancy , within a trial comparing the efficacy of sulfadoxine-pyrimethamine and mefloquine .
METHODS	Hb concentrations of pregnant women were determined from venous blood samples collected at first and second ANC visits of at least 1-month interval and at delivery .
METHODS	Women were prescribed oral iron , folic acid , and anthelminthics after the first ANC visit .
METHODS	A total of 636 children ( 76.8 % of eligible children ) were assessed by trained research nurses for cognitive and motor functions by using the Mullen Scales of Early Learning .
RESULTS	Prevalence of anemia ( Hb < 110 g/L ) decreased from 67.0 % at first ANC visit ( mean gestational age [ SD ] , 22.1 [ 4.0 ] weeks ) to 38.4 % at delivery .
RESULTS	Mean ( SD ) Hb concentrations increased from 103.7 ( 12.3 ) at first ANC visit to 112.4 ( 14.1 ) at delivery .
RESULTS	We observed a significant negative quadratic relationship between infant gross motor ( GM ) function and Hb concentration at first and second ANC visits .
RESULTS	Thus , infant GM scores increased sharply with increasing maternal Hb concentration until 90 g/L where increasing GM was mild , and began to decline after 110 g/L .
CONCLUSIONS	There appears to be an Hb concentration range that may be optimal for GM function of 1-year-old children .
CONCLUSIONS	This may reflect the importance of physiologic hemodilution , which occurs after the second trimester until 34 weeks of gestation .

###25315667
OBJECTIVE	Hypertension is one of the main cardiovascular risk factors in the elderly .
OBJECTIVE	The aims of this work were to evaluate if a one-year intervention with two Mediterranean diets ( Med-diet ) could decrease blood pressure ( BP ) due to a high polyphenol consumption , and if the decrease in BP was mediated by plasma nitric oxide ( NO ) production .
RESULTS	An intervention substudy of 200 participants at high cardiovascular risk was carried out within the PREDIMED trial .
RESULTS	They were randomly assigned to a low-fat control diet or to two Med-diets , one supplemented with extra virgin olive oil ( Med-EVOO ) and the other with nuts ( Med-nuts ) .
RESULTS	Anthropometrics and clinical parameters were measured at baseline and after one year of intervention , as well as BP , plasma NO and total polyphenol excretion ( TPE ) in urine samples .
RESULTS	Systolic and diastolic BP decreased significantly after a one-year dietary intervention with Med-EVOO and Med-nuts .
RESULTS	These changes were associated with a significant increase in TPE and plasma NO .
RESULTS	Additionally , a significant positive correlation was observed between changes in urinary TPE , a biomarker of TP intake , and in plasma NO ( Beta = 4.84 ; 95 % CI : 0.57-9 .10 ) .
CONCLUSIONS	TPE in spot urine sample was positively correlated with plasma NO in Med-diets supplemented with either EVOO or nuts .
CONCLUSIONS	The statistically significant increases in plasma NO were associated with a reduction in systolic and diastolic BP levels , adding to the growing evidence that polyphenols might protect the cardiovascular system by improving the endothelial function and enhancing endothelial synthesis of NO .

###24485397
OBJECTIVE	The enzyme dipeptidyl peptidase-4 ( DPP-4 ) is a key player in the degradation of incretin hormones that are involved in glucose metabolism .
OBJECTIVE	DPP-4 is also expressed on immune cells and is associated with several immunological functions .
OBJECTIVE	Some studies have reported increased rates of infections in patients treated with DPP-4 inhibitors .
OBJECTIVE	We therefore assessed whether treatment with the DPP-4 inhibitor vildagliptin affected cytokine production and T-cell differentiation .
METHODS	Patients with type 2 diabetes were treated with vildagliptin or an active comparator , acarbose , for four weeks , in a randomized cross-over trial .
METHODS	Blood was sampled at the end of each treatment period and peripheral blood mononuclear cells were isolated and stimulated with a broad spectrum of pattern recognition receptor agonists .
RESULTS	Serum cytokine concentrations and ex vivo cytokine production ( both monocyte and T-cell derived ) did not differ during treatment with vildagliptin compared to acarbose .
RESULTS	Similarly , ex vivo relative upregulation of mRNA transcription of T-cell lineage specific transcription factors was unaffected by vildagliptin treatment .
CONCLUSIONS	These data show that a four-week treatment with vildagliptin in patients with type 2 diabetes mellitus does not result in a significant modulation of cytokine responses .
CONCLUSIONS	This observation suggests that inhibition of DDP-4 does not lead to an increased risk of infection by diminishing cytokine production .

###25453517
BACKGROUND	Minimal hepatic encephalopathy ( MHE ) impairs patients ' cognitive and neurophysiological functions .
BACKGROUND	In this study , we investigated the effect of treatment-related improvement in cognitive and neurophysiological functions .
METHODS	We measured psychometric performance by number connection tests part A ( NCT-A ) , digit symbol test ( DST ) , mini-mental state examination ( MMSE ) and event related potential P300 wave of 80 patients with cirrhosis who have minimal hepatic encephalopathy on inclusion into the study and 15 days later .
METHODS	They were randomly assigned in a 1:1:1:1 ratio to four groups , to receive treatment of Chinese herbal medicine formula ( HMG ) or lactulose ( LG ) or Chinese herbal medicine formula combined with lactulose ( HMCLG ) for 15 days ( n = 20 ) or no treatment ( CG ) ( n = 20 ) .
METHODS	This study was not blind .
RESULTS	The mean number of NCT-A and MMSE scores improved significantly in patients in the HMG ( 0 day , 102.0024.49 for NCT-A , 18.552.89 for MMSE ; 15 days , 78.3022.55 for NCT-A , 24.202.78 for MMSE ) compared with patients in the CG after 15 days of follow-up ( 0 day , 103.0024.98 for NCT-A , 17.902.99 for MMSE ; 15 days , 95.6524.34 for NCT-A , 18.853.12 for MMSE ) , P < 0.05 ; the mean number of P300 latency ( ms ) and wave amplitude ( V ) improved significantly among patients in the HMG after 15 days of treatment ( 0 day , 341.9014.04 for latency , 8.401.73 for wave amplitude ; 15 days , 305.4523.95 for latency , 13.003.80 for wave amplitude ) compared with patients in the CG after 15 days of follow-up ( 0 day , 343.8514.88 for latency , 8.291.77 for wave amplitude ; 15 days , 340.4013.06 for latency , 8.501.82 for wave amplitude ) , P < 0.05 .
RESULTS	Similar improvement were also found among patients in the LG and HMCLG ; improvements among patients in the HMG were significantly greater than they were in the LG ( P < 0.05 ) .
RESULTS	Synergistic action were shown among patients in the HMCLG ( P < 0.05 ) .
CONCLUSIONS	Treatment with Chinese herbal medicine formula Jieduhuayu granules and lactulose may improve cognitive and neurophysiological functions in patients with cirrhosis who have MHE .
CONCLUSIONS	Compared with lactulose alone , Chinese herbal medicine formula Jieduhuayu granules has higher efficacy of improving cognitive and neurophysiological functions in patients with cirrhosis who have MHE , and the two of them together show synergistic action .
BACKGROUND	ACTRN12614000193673 .

###24800362
BACKGROUND	Renal stone disease is a significant and worldwide health problem .
BACKGROUND	Recent advances in stone management have allowed kidney stones to be treated using extracorporeal shock wave lithotripsy ( ESWL ) , uretero-renoscopy ( URS ) , and percutaneous nephrostolithotomy ( PCNL ) .
BACKGROUND	Recently , medical expulsion therapy ( MET ) has been investigated as a supplement to observation in an effort to improve spontaneous stone passage rates .
METHODS	This study was a randomized , controlled , prospective study to determine whether the administration of Alpha-1-adrenergic receptor antagonists as an adjunctive medical therapy , increases the efficacy of ESWL to treat renal stones .
METHODS	Sixty patients with renal stones of 0.5-1 .5 Cm in size ( average size 1.2 Cm ) were included in this study underwent ESWL followed by administration of Alpha-1-adrenergic receptor antagonists at department of Urology Liaquat National Hospital Karachi from Feb 2008 to Sept 2008 .
METHODS	This was a comparative study and patients were divided into two groups .
METHODS	In group A patients received conventional treatment Diclofenac sodium , Anti Spasmodic ( Drotverine HCl ) as required and Proton Pump inhibitor ( Omeprazole 20 mg ) once daily after shock wave lithotripsy .
METHODS	In group B patients received alpha-1 blocker , Alfuzosin HCI 5 mg twice daily in addition to conventional treatment .
METHODS	All patients were instructed to drink a minimum of 2 litres water daily .
METHODS	Ultrasound guided Dornier Alpha Impact Lithotripter was utilised for shock wave lithotripsy .
RESULTS	Of the 60 patients , 76.7 % of those receiving Alfuzosin and 46.7 % of controls had achieved clinical success at 1 month ( p = 0.01 ) .
RESULTS	The mean cumulative diclofenac dose was 485 mg per patient in the Alfuzosin group and 768 mg per patient in the control group ( p = 0.002 ) .
RESULTS	This difference was statistically significant .
CONCLUSIONS	Alfuzosin therapy as an adjunctive medical therapy after ESWL is more effective than lithotripsy alone for the treatment of patients with large renal stones and is equally safe .
CONCLUSIONS	It increases the expulsion rates of stones , decreases time to expulsion , and decreases need for analgesia during stone passage .

###25648577
BACKGROUND	Previous studies have demonstrated the psychosocial effect of heart failure in patients with reduced ejection fraction .
BACKGROUND	However , the effects on patients with preserved ejection fraction have not yet been elucidated .
BACKGROUND	This study aimed to determine the baseline characteristics of participants with heart failure with preserved ejection fraction as it relates to impaired quality of life ( QOL ) and depression , identify predictors of poor QOL and depression , and determine the correlation between QOL and depression .
RESULTS	Among patients enrolled in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist Trial ( TOPCAT ) , 3400 patients completed the Kansas City Cardiomyopathy Questionnaire , 3395 patients completed European QOL 5D Visual Analog Scale , and 1431 patients in United States and Canada completed the Patient Health Questionnaire-9 .
RESULTS	The mean summary score on the Kansas City Cardiomyopathy Questionnaire was 54.8 , and on European QOL 5D Visual Analog Scale , it was 60.3 ; 27 % of patients had moderate to severe depression .
RESULTS	Factors associated with better Kansas City Cardiomyopathy Questionnaire and European QOL 5D Visual Analog Scale via multiple logistic regression analysis were American region , older age , no history of angina pectoris or asthma , no use of hypoglycemic agent , more activity level , and lower New York Heart Association class .
RESULTS	Factors associated with depression via multiple logistic regression analysis included younger age , female sex , comorbid angina , chronic obstructive pulmonary disease , use of a hypoglycemic agent , lower activity level , higher New York Heart Association class , and selective serotonin reuptake inhibitor use .
RESULTS	There were significant correlations between each of the QOL scores and depression .
CONCLUSIONS	Patients with heart failure with preserved ejection fraction , who were younger had higher New York Heart Association class or comorbid angina pectoris , had lower activity levels , lived in Eastern Europe or were taking hypoglycemic agents , were more likely to have impaired QOL and depression .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00094302 .

###25714532
OBJECTIVE	To compare the efficiency of surgical procedures using three phaco tip designs in torsional phacoemulsification using the bevel-down technique .
METHODS	In this prospective , comparative , masked study , patients were randomly assigned to have torsional coaxial microincision cataract surgery using the mini-flared 45-degree Kelman tip , reversed mini-flared 30-degree Kelman tip , or Sidewinder 30-degree Kelman tip .
METHODS	Clinical measurements included preoperative and 3-month postoperative corrected distance visual acuity ( CDVA ) , endothelial cell counts ( ECC ) , and preoperative and 1-day postoperative central corneal thickness ( CCT ) .
METHODS	Intraoperative measurements included phaco time , torsional time , aspiration time , case time , cumulative dissipated energy ( CDE ) , and balanced salt solution volume ( BSS ) .
RESULTS	The study evaluated 150 eyes of 150 patients .
RESULTS	Intraoperatively , there was no statistically significant difference in cumulative dissipated energy , case time , torsional time , and aspiration time between the three tip configurations .
RESULTS	However , less phaco time was used with the mini-flared 45-degree Kelman tip ( p = 0.02 ) than that with the Sidewinder 30-degree Kelman tip or reversed mini-flared 30-degree Kelman tip .
RESULTS	The mini-flared 45-degree Kelman tip and the reversed mini-flared 30-degree Kelman tip required significantly less balanced salt solution volume than that required by the Sidewinder 30-degree Kelman tip ( p = 0.009 ) .
RESULTS	There was no statistically significant difference in corrected distance visual acuity and endothelial cell counts between tips 3 months postoperatively ( p > 0.05 ) .
CONCLUSIONS	All three tips were effective with no intraoperative complications .
CONCLUSIONS	When using torsional phacoemulsification through microincisions and the prefracture technique with the bevel-down technique , the mini-flared 45-degree Kelman tip required a lower mean phaco time than the reversed mini-flared 30-degree Kelman tip and the Sidewinder 30-degree Kelman tip .

###24858952
OBJECTIVE	To examine the metabolic , gluco-regulatory-hormonal and inflammatory cytokine responses to large reductions in rapid-acting insulin dose administered prandially before and after intensive running exercise in male type 1 diabetes patients .
METHODS	This was a single centre , randomised , controlled open label study .
METHODS	Following preliminary testing , 8 male patients ( 242 years , HbA1c 7.70.4 % / 614 mmol.l-1 ) treated with insulin 's glargine and aspart , or lispro attended the laboratory on two mornings at 08:00 h and consumed a standardised breakfast carbohydrate bolus ( 1 g carbohydrate.kg-1BM ; 38010 kcal ) and self-administered a 75 % reduced rapid-acting insulin dose 60 minutes before 45 minutes of intensive treadmill running at 73.10.9 % VO2peak .
METHODS	At 60 minutes post-exercise , patients ingested a meal ( 1 g carbohydrate.kg-1BM ; 66021 kcal ) and administered either a Full or 50 % reduced rapid-acting insulin dose .
METHODS	Blood glucose and lactate , serum insulin , cortisol , non-esterified-fatty-acids , - Hydroxybutyrate , and plasma glucagon , adrenaline , noradrenaline , IL-6 , and TNF - concentrations were measured for 180 minutes post-meal .
RESULTS	All participants were analysed .
RESULTS	All glycaemic , metabolic , hormonal , and cytokine responses were similar between conditions up to 60 minutes following exercise .
RESULTS	Following the post-exercise meal , serum insulin concentrations were lower under 50 % ( p < 0.05 ) resulting in 75 % of patients experiencing hyperglycaemia ( blood glucose 8.0 mmol.l-1 ; 50 % n = 6 , Full n = 3 ) .
RESULTS	- Hydroxybutyrate concentrations decreased similarly , such that at 180 minutes post-meal concentrations were lower than rest under Full and 50 % .
RESULTS	IL-6 and TNF - concentrations remained similar to fasting levels under 50 % but declined under Full .
RESULTS	Under 50 % IL-6 concentrations were inversely related with serum insulin concentrations ( r = -0.484 , p = 0.017 ) .
CONCLUSIONS	Heavily reducing rapid-acting insulin dose with a carbohydrate bolus before , and a meal after intensive running exercise may cause hyperglycaemia , but does not augment ketonaemia , raise inflammatory cytokines TNF - and IL-6 above fasting levels , or cause other adverse metabolic or hormonal disturbances .
BACKGROUND	ClinicalTrials.gov NCT01531855 .

###24249423
OBJECTIVE	To assess the impact of hexaminolevulinate ( HAL ) on the long-term recurrence rate of NMIBC .
METHODS	A total of 130 patients with bladder tumour were randomized into two groups .
METHODS	The patients in one group had a HAL instillation before surgery , and they first had a white-light and after that a blue-light cystoscopy ( BL group ) and resection .
METHODS	The second group had only white-light cystoscopy ( WL group ) and resection .
METHODS	They have been followed up with cystoscopy every 3 months for a period of up to 40 months .
RESULTS	The recurrence-free period was not significantly different between the two groups ( BL and WL groups ) ( long-rank test p = 0.202 ) .
RESULTS	The use of HAL helped detect four flat lesions and 28 papillary lesions with cancer that would have been missed under WL only , on 16 out of the 54 patients ( 29.6 % CI 95 % 11.1-33 .3 ) .
RESULTS	The use of HAL changed the proposed postoperative treatment and follow-up for one out of the five patients .
CONCLUSIONS	Although the use of HAL cystoscopy identified at least one cancer lesion more than WL cystoscopy on one out of the three patients , the recurrence-free period was not significantly different .

###24227635
BACKGROUND	Selective serotonin reuptake inhibitors ( SSRIs ) are often prescribed in patients with postural tachycardia syndrome ( POTS ) , and act at synaptic terminals to increase monoamine neurotransmitters .
BACKGROUND	We hypothesized that they act to increase blood pressure and attenuate reflex tachycardia , thereby improving symptoms .
BACKGROUND	Acute hemodynamic profiles after SSRI administration in POTS patients have not previously been reported .
METHODS	Patients with POTS ( n = 39 ; F = 37 , 39 9 years ) underwent a randomized crossover trial with sertraline 50mg and placebo .
METHODS	Heart rate , systolic , diastolic , and mean blood pressure were measured with the patient seated and standing for 10 min prior to drug or placebo administration , and then hourly for 4 h.
METHODS	The primary endpoint was standing heart rate at 4 h.
RESULTS	At 4 h , standing heart rate and systolic blood pressure were not significantly different between sertraline and placebo .
RESULTS	Seated systolic ( 10612 mmHg vs. 1018 mmHg ; p = 0.041 ) , diastolic ( 728 mmHg vs. 698 mmHg ; p = 0.022 ) , and mean blood pressure ( 869 mmHg vs. 819 mmHg ; p = 0.007 ) were significantly higher after sertraline administration than placebo .
RESULTS	At 4 h , symptoms were worse with sertraline than placebo .
CONCLUSIONS	Sertraline had a modest pressor effect in POTS patients , but this did not translate into a reduced heart rate or improved symptoms .

###25227627
OBJECTIVE	To determine whether nalmefene combined with psychosocial support is cost-effective compared with psychosocial support alone for reducing alcohol consumption in alcohol-dependent patients with high/very high drinking risk levels ( DRLs ) as defined by the WHO , and to evaluate the public health benefit of reducing harmful alcohol-attributable diseases , injuries and deaths .
METHODS	Decision modelling using Markov chains compared costs and effects over 5 years .
METHODS	The analysis was from the perspective of the National Health Service ( NHS ) in England and Wales .
METHODS	The model considered the licensed population for nalmefene , specifically adults with both alcohol dependence and high/very high DRLs , who do not require immediate detoxification and who continue to have high/very high DRLs after initial assessment .
METHODS	We modelled treatment effect using data from three clinical trials for nalmefene ( ESENSE 1 ( NCT00811720 ) , ESENSE 2 ( NCT00812461 ) and SENSE ( NCT00811941 ) ) .
METHODS	Baseline characteristics of the model population , treatment resource utilisation and utilities were from these trials .
METHODS	We estimated the number of alcohol-attributable events occurring at different levels of alcohol consumption based on published epidemiological risk-relation studies .
METHODS	Health-related costs were from UK sources .
METHODS	We measured incremental cost per quality-adjusted life year ( QALY ) gained and number of alcohol-attributable harmful events avoided .
RESULTS	Nalmefene in combination with psychosocial support had an incremental cost-effectiveness ratio ( ICER ) of 5204 per QALY gained , and was therefore cost-effective at the 20,000 per QALY gained decision threshold .
RESULTS	Sensitivity analyses showed that the conclusion was robust .
RESULTS	Nalmefene plus psychosocial support led to the avoidance of 7179 alcohol-attributable diseases/injuries and 309 deaths per 100,000 patients compared to psychosocial support alone over the course of 5 years .
CONCLUSIONS	Nalmefene can be seen as a cost-effective treatment for alcohol dependence , with substantial public health benefits .
BACKGROUND	This cost-effectiveness analysis was developed based on data from three randomised clinical trials : ESENSE 1 ( NCT00811720 ) , ESENSE 2 ( NCT00812461 ) and SENSE ( NCT00811941 ) .

###25467395
BACKGROUND	Timed Up and Go ( TUG ) performance is reduced following stroke .
BACKGROUND	Gait training improves gait-related activities in hemiparetic patients .
BACKGROUND	However , no study has compared the impact of a single overground training session with a treadmill training session on gait-related activities ( assessed by TUG ) .
OBJECTIVE	To compare the immediate effect of a single overground training session versus a single treadmill training session on TUG performance in hemiparetic patients .
METHODS	In this randomized controlled clinical trial , 56 hemiparetic patients were randomized to 1 or 2 distinct groups : a single gait training session overground ( O group ) or on a treadmill ( T group ) .
METHODS	Time taken to perform the TUG ( in seconds ) was assessed before and immediately after the completion of each session .
RESULTS	Time taken to perform the TUG decreased significantly , and to a similar extent , in both groups following the training session ( O group , 5.9 % ; T group , 5.2 % ) .
CONCLUSIONS	An overground training session and a treadmill training session were equally effective in improving TUG performance in hemiparetic patients .
CONCLUSIONS	Hemiparetic patients should be encouraged to walk regularly overground including turns for 20 minutes without stopping .
CONCLUSIONS	This is an easy and inexpensive self-rehabilitation method to improve functional gait-related activities involved in the TUG test .

###25017249
BACKGROUND	The World Cancer Research Fund ( WCRF ) and the American Institute for Cancer Research ( AICR ) published eight recommendations for cancer prevention , but they are not targeted at prostate cancer prevention .
BACKGROUND	We investigated whether adherence to the WCRF/AICR recommendations and a prostate cancer dietary index is associated with prostate cancer risk .
METHODS	We conducted a nested case-control study of 1,806 prostate-specific antigen ( PSA ) - detected prostate cancer cases and 12,005 controls in the ProtecT trial .
METHODS	We developed a prostate cancer dietary index by incorporating three dietary factors most strongly associated with prostate cancer .
METHODS	Scores were computed to quantify adherence to the WCRF/AICR recommendations and the prostate cancer dietary index separately .
RESULTS	The prostate cancer dietary index score was associated with decreased risk of prostate cancer [ OR per 1 score increment : 0.91 ; 95 % confidence interval ( CI ) : 0.84-0 .99 ; Ptrend = 0.04 ] but the WCRF/AICR index score was not ( OR : 0.99 ; 95 % CI : 0.94-1 .05 ; Ptrend = 0.71 ) .
RESULTS	There was no heterogeneity in association by prostate cancer stage ( P = 0.81 ) or grade ( P = 0.61 ) .
RESULTS	Greater adherence to recommendations to increase plant foods ( OR per 0.25 index score increment : 0.94 ; 95 % CI : 0.89-0 .99 ; Ptrend = 0.02 ) and tomato products ( OR adherence vs. nonadherence : 0.82 ; 95 % CI : 0.70-0 .97 ; P = 0.02 ) was inversely associated with overall prostate cancer risk .
CONCLUSIONS	Adherence to the prostate cancer-specific dietary recommendations was associated with decreased risk of prostate cancer .
CONCLUSIONS	High intake of plant foods and tomato products in particular may help protect against prostate cancer .
CONCLUSIONS	Meeting the WCRF/AICR recommendations alone is insufficient for prostate cancer prevention .
CONCLUSIONS	Additional dietary recommendations should be developed .

###24368315
OBJECTIVE	We assessed whether wheat bran extract ( WBE ) containing arabinoxylan-oligosaccharides ( AXOS ) elicited a prebiotic effect and modulated gastrointestinal ( GI ) parameters in healthy preadolescent children upon consumption in a beverage .
METHODS	This double-blind randomized placebo-controlled crossover trial evaluated the effects of consuming WBE at 0 ( control ) or 5.0 g/day for 3 weeks in 29 healthy children ( 8-12 years ) .
METHODS	Fecal levels of microbiota , short-chain fatty acids , branched-chain fatty acids , ammonia , moisture , and fecal pH were assessed at the end of each treatment and at the end of a 1-week run-in ( RI ) period .
METHODS	In addition , the subjects completed questionnaires scoring distress severity of 3 surveyed GI symptoms .
METHODS	Finally , subjects recorded defecation frequency and stool consistency .
RESULTS	Nominal fecal bifidobacteria levels tended to increase after 5 g/day WBE consumption ( P = 0.069 ) , whereas bifidobacteria expressed as percentage of total fecal microbiota was significantly higher upon 5 g/day WBE intake ( P = 0.002 ) .
RESULTS	Additionally , 5 g/day WBE intake induced a significant decrease in fecal content of isobutyric acid and isovaleric acid ( P < 0.01 ) , markers of protein fermentation .
RESULTS	WBE intake did not cause a change in distress severity of the 3 surveyed GI symptoms ( flatulence , abdominal pain/cramps , and urge to vomit ) ( P > 0.1 ) .
CONCLUSIONS	WBE is well tolerated at doses up to 5 g/day in healthy preadolescent children .
CONCLUSIONS	In addition , the intake of 5 g/day exerts beneficial effects on gut parameters , in particular an increase in fecal bifidobacteria levels relative to total fecal microbiota , and reduction of colonic protein fermentation .

###24460645
BACKGROUND	D-dimer concentrations have not been evaluated extensively as a predictor of increased venous thromboembolism ( VTE ) risk in acutely ill , hospitalized medical patients .
OBJECTIVE	To analyze the relationships between D-dimer concentration , VTE and bleeding in the MAGELLAN trial ( NCT00571649 ) .
METHODS	This was a multicenter , randomized , controlled trial .
METHODS	Patients aged 40years , hospitalized for acute medical illnesses with risk factors for VTE received subcutaneous enoxaparin 40mg once daily for 104days then placebo up to day 35 , or oral rivaroxaban 10mg once daily for 354days .
METHODS	Patients ( n = 7581 ) were grouped by baseline D-dimer 2or > 2the upper limit of normal .
METHODS	VTE and major plus non-major clinically relevant bleeding were recorded at day 10 , day 35 , and between days 11 and 35 .
RESULTS	The frequency of VTE was 3.5-fold greater in patients with high D-dimer concentrations .
RESULTS	Multivariate analysis showed that D-dimer was an independent predictor of the risk of VTE ( odds ratio 2.29 [ 95 % confidence interval 1.75-2 .98 ] ) , and had a similar association to established risk factors for VTE , for example cancer and advanced age .
RESULTS	In the high D-dimer group , rivaroxaban was non-inferior to enoxaparin at day10 and , unlike the low D-dimer group , superior to placebo at day 35 ( P < 0.001 ) and days 11-35 ( P < 0.001 ) .
RESULTS	In both groups , bleeding outcomes favored enoxaparin/placebo .
CONCLUSIONS	Elevated baseline D-dimer concentrations may identify acutely ill , hospitalized medical patients at high risk of VTE for whom extended anticoagulant prophylaxis may provide greater benefit than for those with low D-dimer concentrations .

###25895520
OBJECTIVE	Sacral nerve stimulation ( SNS ) is a potential treatment for constipation refractory to standard therapies .
OBJECTIVE	However , there have been no randomized controlled studies examining its efficacy .
OBJECTIVE	In patients with slow transit constipation , we evaluated the efficacy of suprasensory and subsensory SNS compared with sham , in a prospective , 18-week randomized , double-blind , placebo-controlled , two-phase crossover study .
OBJECTIVE	The primary outcome measure was the proportion of patients who , on more than 2 days/week for at least 2 of 3 weeks , reported a bowel movement associated with a feeling of complete evacuation .
METHODS	After 3 weeks of temporary peripheral nerve evaluation ( PNE ) , all patients had permanent implantation and were randomized to subsensory/sham ( 3 weeks each ) and then re-randomized to suprasensory/sham ( 3 weeks each ) with a 2-week washout period between each arm .
METHODS	Daily stool dairies were kept , and quality of life ( QoL ; SF36 ) was measured at the end of each arm .
RESULTS	Between November 2006 and March 2012 , 234 constipated patients were assessed , of whom 59 were willing and deemed eligible to participate ( 4 male ; median age 42 years ) .
RESULTS	Of the 59 patients , 16 ( 28 % ) responded to PNE .
RESULTS	Fifty-five patients went on to permanent SNS implantation .
RESULTS	The proportion of patients satisfying the primary outcome measure did not differ between suprasensory ( 30 % ) and sham ( 21 % ) stimulations , nor between subsensory ( 25 % ) and sham ( 25 % ) stimulations .
RESULTS	There were no significant changes in QoL scores .
CONCLUSIONS	In patients with refractory slow transit constipation , SNS did not improve the frequency of complete bowel movements over the 3-week active period .

###24742939
OBJECTIVE	To investigate the long-term effects of home-based constraint induced therapy ( CIT ) on motor control underlying functional change in children with unilateral cerebral palsy ( CP ) .
METHODS	Randomized controlled trial .
METHODS	Home based .
METHODS	Children with unilateral CP ( N = 45 ; aged 6-12 y ) were randomly assigned to receive home-based CIT ( n = 23 ) or traditional rehabilitation ( TR ) ( n = 22 ) .
METHODS	Both groups received a 4-week therapist-based intervention at home .
METHODS	The home-based CIT involved intensive functional training of the more affected upper extremity during which the less affected one was restrained .
METHODS	The TR involved functional unimanual and bimanual training .
METHODS	All children underwent kinematic and clinical assessments at baseline , 4 weeks ( posttreatment ) , and 3 and 6 months ( follow-up ) .
METHODS	The reach-to-grasp kinematics were reaction time ( RT ) , normalized movement time , normalized movement unit , peak velocity ( PV ) , maximum grip aperture ( MGA ) , and percentage of movement where MGA occurs .
METHODS	The clinical measures were the Peabody Developmental Motor Scales , Second Edition ( PDMS-2 ) , Bruininks-Oseretsky Test of Motor Proficiency ( BOTMP ) , and Functional Independence Measure for children ( WeeFIM ) .
RESULTS	The home-based CIT group showed a shorter RT ( P < .05 ) and normalized movement time ( P < .01 ) , smaller MGA ( P = .006 ) , and fewer normalized movement units ( P = .014 ) in the reach-to-grasp movements at posttreatment and follow-up than the TR group .
RESULTS	The home-based CIT group improved more on the PDMS-2 ( P < .001 ) and WeeFIM ( P < .01 ) in all posttreatment tests and on the BOTMP ( P < .01 ) at follow-up than the TR group .
CONCLUSIONS	The home-based CIT induced better spatial and temporal efficiency ( smoother movement , more efficient grasping , better movement preplanning and execution ) for functional improvement up to 6 months after treatment than TR .

###24840583
BACKGROUND	Chronic ankle instability is characterized by repetitive lateral ankle sprains .
BACKGROUND	Prophylactic ankle taping is a common intervention used to reduce the risk of ankle sprains .
BACKGROUND	However , little research has been conducted to evaluate the effect ankle taping has on gait kinematics .
OBJECTIVE	To investigate the effect of taping on ankle and knee kinematics during walking and jogging in participants with chronic ankle instability .
METHODS	Controlled laboratory study .
METHODS	Motion analysis laboratory .
METHODS	A total of 15 individuals ( 8 men , 7 women ; age = 26.9 6.8 years , height = 171.7 6.3 cm , mass = 73.5 10.7 kg ) with self-reported chronic ankle instability volunteered .
METHODS	They had an average of 5.3 3.1 incidences of ankle sprain .
METHODS	Participants walked and jogged in shoes on a treadmill while untaped and taped .
METHODS	The tape technique was a traditional preventive taping procedure .
METHODS	Conditions were randomized .
METHODS	Frontal-plane and sagittal-plane ankle and sagittal-plane knee kinematics were recorded throughout the entire gait cycle .
METHODS	Group means and 90 % confidence intervals were calculated , plotted , and inspected for percentages of the gait cycle in which the confidence intervals did not overlap .
RESULTS	During walking , participants were less plantar flexed from 64 % to 69 % of the gait cycle ( mean difference = 5.73 0.54 ) and less inverted from 51 % to 61 % ( mean difference = 4.34 0.65 ) and 76 % to 81 % ( mean difference = 5.55 0.54 ) of the gait cycle when taped .
RESULTS	During jogging , participants were less dorsiflexed from 12 % to 21 % ( mean difference = 4.91 0.18 ) and less inverted from 47 % to 58 % ( mean difference = 6.52 0.12 ) of the gait cycle when taped .
RESULTS	No sagittal-plane knee kinematic differences were found .
CONCLUSIONS	In those with chronic ankle instability , taping resulted in a more neutral ankle position during walking and jogging in shoes on a treadmill .
CONCLUSIONS	This change in foot positioning and the mechanical properties of the tape may explain the protective aspect of taping in preventing lateral ankle sprains .

###25194402
BACKGROUND	Dysregulation of CD4 + T cell subsets participates in the pathogenesis of immunoglobulin A nephropathy ( IgAN ) .
BACKGROUND	Vitamin D has immunomodulatory functions .
BACKGROUND	This study aims to investigate the regulatory effect of vitamin D3 on T helper - regulatory T ( Th17-Treg ) cells balance in rats with IgAN .
METHODS	Sprague-Dawley rats were randomly assigned to a normal group ( n = 6 ) , an IgAN model group ( n = 5 ) , a prednisone treatment IgAN group ( n = 6 ) , a 1,25-dihydroxyvitamin D3 IgAN group ( n = 6 ) , and prednisone plus 1,25-dihydroxyvitamin D3 treatment group ( n = 6 ) .
METHODS	At week 12 , the 24-hour urine protein excretion and erythrocyte count and renal pathological changes were determined , and serum interleukin-17 and Treg cell levels were measured in blood .
RESULTS	The urine protein content and the number of erythrocytes were lower in the vitamin D group than in the model group ( P < .01 ) , but higher than in the prednisone groups ( P < 0.01 ) .
RESULTS	The pathological impairments in the glomerular mesangium , renal tubule , and renal interstitium decreased in response to treatment with prednisone with and without 1,25-dihydroxyvitamin D3 .
RESULTS	Serum interleukin-17 level in the vitamin D and prednisone plus vitamin D groups was lower than in the prednisone group ( P < .05 ) .
RESULTS	The Treg cells in the vitamin D and prednisone plus vitamin D groups showed higher levels than in the prednisone group ( P < .01 ) .
CONCLUSIONS	Vitamin D3 can regulate the Th17/Treg balance and reduce the level of protein and blood in the urine of rats with IgAN .

###25182250
OBJECTIVE	Patients undergoing catheter ablation for atrial fibrillation ( AF ) often experience recurrent arrhythmias within the first few months post-ablation .
OBJECTIVE	We aimed to investigate whether short-term use of amiodarone to prevent early arrhythmias following radiofrequency ablation for AF could reduce later recurrence .
RESULTS	In a two-centre , randomized , double-blind , placebo-controlled study , we randomized a total of 212 patients undergoing AF ablation .
RESULTS	Patients were stratified according to type of AF ( paroxysmal/persistent ) and history of previous AF ablation and randomly assigned to 8 weeks of oral amiodarone therapy or matched placebo following catheter ablation .
RESULTS	Patients were followed for 6 months .
RESULTS	Analyses were performed according to the intention-to-treat principle .
RESULTS	Of 212 enrolled patients [ median age 61 ( inter-quartile range 54-66 ) , 83 % male , 50 % paroxysmal , 29 % with history of previous ablation ] , 206 patients were available for analysis of the primary end-point which was any documented atrial tachyarrhythmia lasting > 30 s following a blanking period of 3 months .
RESULTS	This was observed in 42/107 ( 39 % ) in the amiodarone group vs. 48/99 ( 48 % ) in the placebo group ( P = 0.18 ) .
RESULTS	Among the secondary end-points , the amiodarone group showed significantly lower rate of atrial tachyarrhythmia-related hospitalizations [ rate ratio = 0.43 ; 95 % confidence interval ( CI ) = 0.23-0 .77 , P = 0.006 ] and cardioversions ( rate ratio = 0.36 ; 95 % CI = 0.20-0 .62 , P = 0.0004 ) within the blanking period .
CONCLUSIONS	Short-term oral amiodarone treatment following ablation for paroxysmal or persistent AF did not significantly reduce recurrence of atrial tachyarrhythmias at the 6-month follow-up , but it more than halved atrial arrhythmia related hospitalization and cardioversion rates during the blanking period .

###25034548
OBJECTIVE	This study aimed to observe the effects of a concurrent physical training program ( CPTP ) on aerobic power and body composition in adults .
METHODS	The final sample was composed of 71 non-athletic men , randomized into 2 groups : experimental group ( EG , N. = 42 , 458.46 years ) and control group ( CG , N. = 29 , 478.34 years ) .
METHODS	Body composition was assessed by Dual Energy X-ray Absorptiometry ( DEXA ) and aerobic power by maximal oxygen uptake ( VO2max ) , obtained in the Cooper 12-minute run test .
METHODS	CPTP consisted of running training in the Fatmax intensity zone and strength training ( squats and bench presses ) ; three 40-minute sessions a week for 24 weeks .
METHODS	Descriptive and inferential analysis ( intra-group : t-test and inter-group : 2x2 ANOVA and Sheffe post-hoc ) was applied , and the Shapiro-Wilk test was used to test sample normality .
METHODS	The significance level was set at 5 % for all tests .
RESULTS	A significant alteration was found in intra-group comparison for the EG , with respect to fat percentage ( D = -1.13 kg ; P < 0.001 ) , lean mass ( D = 0.29 kg ; P = 0.030 ) and VO2max ( D = 1.18 mL/kg/min ; P < 0.001 ) .
CONCLUSIONS	It can be inferred that CPTP caused an increase in aerobic power , evidenced in VO2max and enhanced body composition , with an increase in LM and reduction in F % .

###25450868
OBJECTIVE	The aim of this study was to compare the technical success between left spermatic vein ( LSV ) scleroembolisation achieved with the injection of sclerosant through a diagnostic catheter and through an occluding balloon ( OB ) , in the treatment of male varicocele .
METHODS	From January 2012 to September 2013 , we prospectively enrolled 100 patients with left varicocele and an indication for LSV scleroembolisation related to symptoms or spermiogram anomalies ; patients were randomised to two groups ( we wrote a list of 100 lines assigned casually with A or B and each patient was consecutively allocated to group A or B on the basis of this list ) .
METHODS	Patients in group A underwent injection of the sclerosing agent through an angiographic diagnostic catheter ( free catheter technique ) and patients in group B through an OB catheter ( OB technique ) .
METHODS	In cases of incomplete occlusion of the LSV , the procedure was completed with coils .
METHODS	Total occlusion of the LSV at post-treatment phlebography during a Valsalva manoeuvre before any coil embolisation was considered a technical success .
METHODS	The rate of complications was also evaluated .
METHODS	The Fischer 's test was used for statistical analysis .
RESULTS	We evaluated a total of 90 patients because five patients for each group were not included in the statistical analysis owing to technical problems or complications .
RESULTS	In group A we had a technical success of 75.6 versus 93.4 % in group B , and the difference was statistically significant ( P = 0.003 ) ; in particular , we had to complete the embolisation with insertion of coils in 11 cases ( 24.4 % ) in group A , and in three cases in group B ( 6.6 % ) .
RESULTS	In group A , LSV rupture occurred in four cases ( 8 % ) so the procedure was completed by sclerosant injection through the OB located distally to the lesion .
RESULTS	These patients were not considered for evaluation .
RESULTS	In another case , a high flow shunt towards the inferior vena cava was detected , so the patient underwent OB injection to stop the flow to the shunt , and was not included for statistical evaluation .
RESULTS	In group B , vein rupture with contrast leakage was noted in six cases ( 12 % ) ; nonetheless , all the procedures were completed because the OB was positioned distally to the vessel tear , obviating any retrograde leakage of sclerosant .
RESULTS	In group B , in five cases ( 10 % ) , we were unable to advance the OB though the LSV ostium so the procedures were completed with the diagnostic catheter and not considered for statistical evaluation .
CONCLUSIONS	On the basis of our data , the embolisation of the LSV obtained by injecting the sclerosant through an OB rather than through a diagnostic catheter seems to be more effective in achieving total vein embolisation , as well as allowing a controlled injection of sclerosant even in cases of vein rupture .

###25684005
OBJECTIVE	This randomized , controlled , double-blind study was designed to determine the optimal dose of remifentanil for preventing complications associated with the removal of a laryngeal mask airway ( LMA ) without delaying emergence .
METHODS	This study randomly assigned 128 patients to remifentanil effect-site concentrations ( Ce ) of 0 ng/mL ( group R0 ) , 0.5 ng/mL ( group R0 .5 ) , 1.0 ng/mL ( group R1 .0 ) , and 1.5 ng/mL ( group R1 .5 ) during emergence .
METHODS	The emergence and recovery profiles were recorded .
METHODS	Adverse events such as coughing , airway obstruction , breath-holding , agitation , desaturation , nausea , and vomiting were also evaluated .
RESULTS	The number of patients with respiratory complications such as coughing and breath-holding was significantly lower in the R1 .0 and R1 .5 groups than in the R0 group ( p < 0.05 ) .
RESULTS	Emergence agitation also decreased in the R1 .0 and R1 .5 groups ( p < 0.0083 ) .
RESULTS	The time to LMA removal was significantly longer in the R1 .5 group than in the other groups ( p < 0.05 ) .
CONCLUSIONS	Maintaining a remifentanil Ce of 1.0 ng/mL during emergence may suppress adverse events such as coughing , breath-holding , and agitation following the removal of LMA without delayed awakening .

###24597764
BACKGROUND	The standard of care for increasing keratinized tissue ( KT ) and vestibular area is an autogenous free gingival graft ( FGG ) and vestibuloplasty ; however , there is morbidity associated with the harvest of autogenous tissue , and supply is limited .
BACKGROUND	The purpose of this study is to determine if a xenogeneic collagen matrix ( CM ) might be as effective as FGG .
METHODS	This study is a single-masked , randomized , controlled , split-mouth study of 30 patients with insufficient zones of KT ( < 2 mm ) .
METHODS	It uses a within-patient treatment-comparison design to establish non-inferiority of the test ( CM ) versus control ( FGG ) therapy .
METHODS	The primary efficacy endpoint was change in KT width ( KT ) from surgery to 6 months post-surgery .
METHODS	Secondary endpoints included traditional periodontal measures , such as clinical attachment level , recession , and bleeding on probing .
METHODS	Patient-reported pain , discomfort , and esthetic satisfaction were also recorded .
METHODS	Biopsies were obtained at 6 months .
RESULTS	Surgery and postoperative sequelae were uneventful , with normal healing observed at both test and control sites .
RESULTS	The primary outcome , KT width at 6 months , did not establish non-inferiority of CM compared to FGG ( P = 0.9992 ) , with the FGG sites averaging 1.5 mm more KT width than CM sites .
RESULTS	However , the amount of new KT generated for both therapies averaged 2 mm .
RESULTS	Secondary outcomes were not significantly different between test and control sites .
RESULTS	All site biopsies appeared as normal mucoperiosteum with keratinized epithelium .
RESULTS	CM sites achieved better texture and color matches , and more than two-thirds of patients preferred the appearance of their CM sites .
CONCLUSIONS	With the proviso of sufficient KT ( 2 mm in width ) and study goals of lower morbidity , unlimited supply , and patient satisfaction , CM appears to be a suitable substitute for FGG in vestibuloplasty procedures designed to increase KT around teeth .

###25060792
OBJECTIVE	Olive oil polyphenols have shown beneficial properties against cardiovascular risk factors .
OBJECTIVE	Their consumption has been associated with higher cholesterol content in high-density lipoproteins ( HDL ) .
OBJECTIVE	However , data on polyphenol effects on HDL quality are scarce .
OBJECTIVE	We , therefore , assessed whether polyphenol-rich olive oil consumption could enhance the HDL main function , its cholesterol efflux capacity , and some of its quality-related properties , such HDL polyphenol content , size , and composition .
RESULTS	A randomized , crossover , controlled trial with 47 healthy European male volunteers was performed .
RESULTS	Participants ingested 25 mL/d of polyphenol-poor ( 2.7 mg/kg ) or polyphenol-rich ( 366 mg/kg ) raw olive oil in 3-week intervention periods , preceded by 2-week washout periods .
RESULTS	HDL cholesterol efflux capacity significantly improved after polyphenol-rich intervention versus the polyphenol-poor one ( +3.05 % and -2.34 % , respectively ; P = 0.042 ) .
RESULTS	Incorporation of olive oil polyphenol biological metabolites to HDL , as well as large HDL ( HDL2 ) levels , was higher after the polyphenol-rich olive oil intervention , compared with the polyphenol-poor one .
RESULTS	Small HDL ( HDL3 ) levels decreased , the HDL core became triglyceride-poor , and HDL fluidity increased after the polyphenol-rich intervention .
CONCLUSIONS	Olive oil polyphenols promote the main HDL antiatherogenic function , its cholesterol efflux capacity .
CONCLUSIONS	These polyphenols increased HDL size , promoted a greater HDL stability reflected as a triglyceride-poor core , and enhanced the HDL oxidative status , through an increase in the olive oil polyphenol metabolites content in the lipoprotein .
CONCLUSIONS	Our results provide for the first time a first-level evidence of an enhancement in HDL function by polyphenol-rich olive oil .

###24438321
BACKGROUND	Repetitive Transcranial Magnetic Stimulation ( rTMS ) is an effective treatment for Major Depressive Disorder ( MDD ) , and is based upon delivery of focal high-energy pulses of electromagnetic stimulation .
BACKGROUND	We postulated that delivery of rTMS at the subject 's individual alpha frequency ( synchronized TMS , or sTMS ) would achieve efficacy with lower energy of stimulation .
BACKGROUND	We developed a device that rotates neodymium cylindrical magnets at three locations along the midline above the subject 's scalp to impart low-energy , sinusoidal-waveform magnetic brain stimulation over a broad area , and performed this efficacy study .
METHODS	Fifty-two subjects with MDD were enrolled in a randomized , sham controlled , double-blind treatment study ( Trial Registration : NCT01683019 ) .
METHODS	Forty-six subjects were included in the final analysis .
METHODS	Most subjects received concurrent antidepressant medications that remained unchanged during the study .
METHODS	Subjects were randomized to three treatment groups : 1 ) active sTMS with a fixed frequency at the subject 's alpha frequency ; 2 ) active sTMS with a random stimulus frequency that varied between 8 Hz and 13 Hz ; and , 3 ) sham sTMS .
METHODS	20 half-hour sTMS sessions were administered 5 days per week for 4 weeks .
RESULTS	Subjects with either fixed or random frequency active sTMS had statistically significantly greater percentage reduction in depression severity compared to sham ( 48.5 % vs. 19.3 % , respectively ; p = 0.001 ) .
RESULTS	No significant difference was found between fixed and random groups ( p = 0.30 ) .
RESULTS	No significant side effects were reported .
CONCLUSIONS	These results suggest that sTMS may be an effective treatment for MDD .

###25323254
BACKGROUND	Although emotional stress is associated with ischemic heart disease ( IHD ) and related clinical events , sex-specific differences in the psychobiological response to mental stress have not been clearly identified .
OBJECTIVE	We aimed to study the differential psychological and cardiovascular responses to mental stress between male and female patients with stable IHD .
METHODS	Patients with stable IHD enrolled in the REMIT ( Responses of Mental Stress-Induced Myocardial Ischemia to Escitalopram ) study underwent psychometric assessments , transthoracic echocardiography , and platelet aggregation studies at baseline and after 3 mental stress tasks .
METHODS	Mental stress-induced myocardial ischemia ( MSIMI ) was defined as the development or worsening of regional wall motion abnormality , reduction of left ventricular ejection fraction ( LVEF ) 8 % by transthoracic echocardiography , and/or ischemic ST-segment change on electrocardiogram during 1 or more of the 3 mental stress tasks .
RESULTS	In the 310 participants with known IHD ( 18 % women , 82 % men ) , most baseline characteristics were similar between women and men ( including heart rate , blood pressure , and LVEF ) , although women were more likely to be nonwhite , living alone ( p < 0.001 ) , and unmarried ( p < 0.001 ) ; they also had higher baseline depression and anxiety ( p < 0.05 ) .
RESULTS	At rest , women had heightened platelet aggregation responses to serotonin ( p = 0.007 ) and epinephrine ( p = 0.004 ) compared with men .
RESULTS	Following mental stress , women had more MSIMI ( 57 % vs. 41 % ; p < 0.04 ) , expressed more negative ( p = 0.02 ) and less positive emotion ( p < 0.001 ) , and demonstrated higher collagen-stimulated platelet aggregation responses ( p = 0.04 ) than men .
RESULTS	Men were more likely than women to show changes in traditional physiological measures , such as blood pressure ( p < 0.05 ) and double product .
CONCLUSIONS	In this exploratory analysis , we identified clear , measurable , and differential responses to mental stress in women and men .
CONCLUSIONS	Further studies should test the association of sex differences in cardiovascular and platelet reactivity in response to mental stress and long-term outcomes .
CONCLUSIONS	( Responses of Myocardial Ischemia to Escitalopram Treatment [ REMIT ] ; NCT00574847 ) .

###24835833
BACKGROUND	Combination long-acting bronchodilator treatment might be more effective than long-acting bronchodilator monotherapy for the treatment of chronic obstructive pulmonary disease ( COPD ) .
BACKGROUND	We aimed to compare the efficacy and safety of umeclidinium ( UMEC ) plus vilanterol ( VI ) with tiotropium ( TIO ) monotherapy , UMEC monotherapy , or VI monotherapy in patients with moderate to very severe COPD .
METHODS	In two multicentre , randomised , blinded , double-dummy , parallel-group , active-controlled trials , eligible patients ( current or former smokers aged 40 years or older with an established clinical history of COPD ) were randomly assigned in 1:1:1:1 ratio to UMEC 125 g plus VI 25 g , UMEC 625 g plus VI 25 g , TIO 18 g , and either VI 25 g ( study 1 ) or UMEC 125 g ( study 2 ) .
METHODS	All study drugs were used once daily for 24 weeks .
METHODS	TIO was delivered via the HandiHaler inhaler and all other active treatments were delivered via the ELLIPTA dry powder inhaler .
METHODS	Random assignment ( by a validated computer-based system ) was done by centre and was not stratified .
METHODS	All patients and physicians were masked to assigned treatment during the studies .
METHODS	The primary efficacy endpoint of both studies was trough forced expiratory volume in 1 s ( FEV1 ) on day 169 , which was analysed in the intention-to-treat population .
METHODS	Both studies are registered with ClinicalTrials.gov , numbers NCT01316900 ( study 1 ) and NCT01316913 ( study 2 ) .
RESULTS	1141 participants were recruited in study 1 , and 1191 in study 2 .
RESULTS	For study 1 , after exclusions , 208 , 209 , 214 , and 212 patients were included in the intention-to-treat analyses for TIO monotherapy , VI monotherapy , UMEC 125 g plus VI 25 g , and UMEC 625 g plus VI 25 g , respectively .
RESULTS	For study 2 , 215 , 222 , 215 , and 217 patients were included in the intention-to-treat analyses for TIO monotherapy , UMEC monotherapy , UMEC 125 g plus VI 25 g , and UMEC 625 g plus VI 25 g , respectively .
RESULTS	In both studies , we noted improvements in trough FEV1 on day 169 for both doses of UMEC plus VI compared with TIO monotherapy ( study 1 , UMEC 125 g plus VI 25 g : 0088 L [ 95 % CI 0036 to 0140 ; p = 00010 ] ; study 1 , UMEC 625 g plus VI 25 g : 0090 L [ 0039 to 0141 ; p = 00006 ] ; study 2 , UMEC 125 g plus VI 25 g : 0074 L [ 0025 to 0123 ; p = 00031 ] ; study 2 , UMEC 625 g plus VI 25 g : 0060 L [ 0010 to 0109 ; nominal p = 00182 ] ) .
RESULTS	Both doses of UMEC plus VI also improved trough FEV1 compared with VI monotherapy ( UMEC 125 g plus VI 25 g : 0088 L [ 0036 to 0140 ; p = 00010 ] ; UMEC 625 g plus VI 25 g : 0090 L [ 0039 to 0142 ; p = 00006 ] , but not compared with UMEC 125 g monotherapy ( UMEC 125 g plus VI 25 g : 0037 L [ -0012 to 0087 ; p = 014 ] ; UMEC 625 g plus VI 25 g : 0022 L [ -0027 to 0072 ; p = 038 ] ) .
RESULTS	All treatments produced improvements in dyspnoea and health-related quality of life ; we noted no significant differences in symptoms , health status , or risk of exacerbation between UMEC plus VI and TIO .
RESULTS	The most common on-treatment , severe-intensity adverse event in both studies was acute exacerbation of COPD ( 1-4 [ < 1-2 % ] patients across treatment groups in study 1 and 1-6 [ < 1-3 % ] patients in study 2 ) .
RESULTS	We recorded five to 15 ( 2-7 % ) on-treatment serious adverse events across treatment groups in study 1 , and nine to 22 ( 4-10 % ) in study 2 .
RESULTS	We noted no substantial changes from baseline in vital signs , clinical laboratory findings , or electrocardiography findings in any of the treatment groups .
CONCLUSIONS	Combination treatment with once-daily UMEC plus VI improved lung function compared with VI monotherapy and TIO monotherapy in patients with COPD .
CONCLUSIONS	Overall our results suggest that the combination of UMEC plus VI could be beneficial for the treatment of moderate to very severe COPD .
BACKGROUND	GlaxoSmithKline .

###24556041
BACKGROUND	Definitive chemoradiotherapy is a curative treatment option for oesophageal carcinoma , especially in patients unsuitable for surgery .
BACKGROUND	The PRODIGE5/ACCORD17 trial aimed to assess the efficacy and safety of the FOLFOX treatment regimen ( fluorouracil plus leucovorin and oxaliplatin ) versus fluorouracil and cisplatin as part of chemoradiotherapy in patients with localised oesophageal cancer .
METHODS	We did a multicentre , randomised , open-label , parallel-group , phase 2/3 trial of patients aged 18 years or older enrolled from 24 centres in France between Oct 15 , 2004 , and Aug 25 , 2011 .
METHODS	Eligible participants had confirmed stage I-IVA oesophageal carcinoma ( adenocarcinoma , squamous-cell , or adenosquamous ) , Eastern Cooperative Oncology Group ( ECOG ) status 0-2 , sufficient caloric intake , adequate haematological , renal , and hepatic function , and had been selected to receive definitive chemoradiotherapy .
METHODS	Patients were randomly assigned ( 1:1 ) to receive either six cycles ( three concomitant to radiotherapy ) of oxaliplatin 85 mg/m ( 2 ) , leucovorin 200 mg/m ( 2 ) , bolus fluorouracil 400 mg/m ( 2 ) , and infusional fluorouracil 1600 mg/m ( 2 ) ( FOLFOX ) over 46 h , or four cycles ( two concomitant to radiotherapy ) of fluorouracil 1000 mg/m ( 2 ) per day for 4 days and cisplatin 75 mg/m ( 2 ) on day 1 .
METHODS	Both groups also received 50 Gy radiotherapy in 25 fractions ( five fractions per week ) .
METHODS	Random allocation to treatment groups was done by a central computerised randomisation procedure by minimisation , stratified by centre , histology , weight loss , and ECOG status , and was achieved independently from the study investigators .
METHODS	The primary endpoint was progression-free survival .
METHODS	Data analysis was primarily done by intention to treat .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00861094 .
RESULTS	134 participants were randomly allocated to the FOLFOX group and 133 to the fluorouracil and cisplatin group ( intention-to-treat population ) , and 131 patients in the FOLFOX group and 128 in the fluorouracil and cisplatin group actually received the study drugs ( safety population ) .
RESULTS	Median follow-up was 253 months ( IQR 159-364 ) .
RESULTS	Median progression-free survival was 97 months ( 95 % CI 81-145 ) in the FOLFOX group and 94 months ( 81-106 ) in the fluorouracil and cisplatin group ( HR 093 , 95 % CI 070-124 ; p = 064 ) .
RESULTS	One toxic death occurred in the FOLFOX group and six in the fluorouracil-cisplatin group ( p = 0066 ) .
RESULTS	No significant differences were recorded in the rates of most frequent grade 3 or 4 adverse events between the treatment groups .
RESULTS	Of all-grade adverse events that occurred in 5 % or more of patients , paraesthesia ( 61 [ 47 % ] events in 131 patients in the FOLFOX group vs three [ 2 % ] in 128 patients in the cisplatin-fluorouracil group , p < 00001 ) , sensory neuropathy ( 24 [ 18 % ] vs one [ 1 % ] , p < 00001 ) , increases in aspartate aminotransferase concentrations ( 14 [ 11 % ] vs two [ 2 % ] , p = 0002 ) , and increases in alanine aminotransferase concentrations ( 11 [ 8 % ] vs two [ 2 % ] , p = 0012 ) were more common in the FOLFOX group , whereas serum creatinine increases ( four [ 3 % ] vs 15 [ 12 % ] , p = 0007 ) , mucositis ( 35 [ 27 % ] vs 41 [ 32 % ] , p = 0011 ) , and alopecia ( two [ 2 % ] vs 12 [ 9 % ] , p = 0005 ) were more common in the fluorouracil and cisplatin group .
CONCLUSIONS	Although chemoradiotherapy with FOLFOX did not increase progression-free survival compared with chemoradiotherapy with fluorouracil and cisplatin , FOLFOX might be a more convenient option for patients with localised oesophageal cancer unsuitable for surgery .
BACKGROUND	UNICANCER , French Health Ministry , Sanofi-Aventis , and National League Against Cancer .

###25151550
BACKGROUND	High definition endoscopy is the accepted standard in colonoscopy .
BACKGROUND	However , an important problem is missed polyps .
OBJECTIVE	Our objective was to assess the additional adenoma detection rate between high definition colonoscopy with tone enhancement ( digital chromoendoscopy ) vs. white light high definition colonoscopy .
METHODS	In this prospective randomized trial patients were included to undergo a tandem colonoscopy .
METHODS	The first exam was a white light colonoscopy with removal of all visualized polyps .
METHODS	The second examination was randomly assigned in a 1:1 ratio as either again white light colonoscopy ( Group A ) or colonoscopy with tone enhancement ( Group B ) .
METHODS	Primary endpoint was the adenoma detection rate during the second withdrawal ( sample size calculation - 40 per group ) .
RESULTS	67 lesions ( Group A : n = 34 vs. Group B : n = 33 ) in 80 patients ( mean age 61 years , male 64 % ) were identified on the first colonoscopy .
RESULTS	The second colonoscopy detected 78 additional lesions : n = 60 with tone enhancement vs. n = 18 with white light endoscopy ( p < 0.001 ) .
RESULTS	Tone enhancement found more additional adenomas ( A n = 20 vs. B n = 6 , p = 0.006 ) and identified significantly more missed adenomas per subject ( 0.5 vs. 0.15 , p = 0.006 ) .
CONCLUSIONS	High definition plus colonoscopy with tone enhancement detected more adenomas missed by white light colonoscopy .

###25126034
OBJECTIVE	Home-based diagnosis of obstructive sleep apnea ( OSA ) with portable monitoring ( PM ) is increasingly utilized , but remains understudied in underserved and minority populations .
OBJECTIVE	We tested the feasibility of home PM in an urban population at risk for OSA compared to in-laboratory polysomnography ( PSG ) and examined patient preference with respect to home PM versus PSG .
METHODS	Randomized crossover study of home PM ( WatchPAT200 ) and in-laboratory simultaneous PSG and PM in 75 urban African Americans with high pre-test probability of OSA , identified with the Berlin questionnaire .
RESULTS	Fifty-seven of 75 participants were women , average age 45 11 years ( mean SD ) , 35 % with high school education , and 76 % with annual household income < $ 50,000 .
RESULTS	Technical failure rates were 5.3 % for home vs. 3.1 % for in-laboratory PM .
RESULTS	There was good agreement between apnea hypopnea index on PSG ; AHIPSG and AHI on home PM ( mean 2 SD of the differences = 0.64 46.5 and intraclass correlation coefficient ; ICC = 0.73 ) .
RESULTS	The areas under the curve for the receiver-operator characteristic curves for home PM were 0.90 for AHIPSG 5 , 0.95 for AHIPSG 10 , and 0.92 for AHIPSG 15.62 / 75 ( 82 % ) participants preferred home over in-laboratory testing .
CONCLUSIONS	Home PM for diagnosis of OSA in a high risk urban population is feasible , accurate , and preferred by patients .
CONCLUSIONS	As home PM may improve access to care , the cost-effectiveness of this diagnostic strategy for OSA should be examined in underserved urban and rural populations .
BACKGROUND	ClinicalTrials.gov , identifier : NCT01997723 .

###25434143
OBJECTIVE	To evaluate the effect of health education path on advanced schistosomiasis patients with splenomegaly in perioperative period .
METHODS	A total of 60 advanced schistosomiasis patients with splenomegaly in perioperative period were randomly divided into an observation group and a control group ( 30 cases each group ) .
METHODS	The patients in the observation group were intervened by the nursing and health education from admission to discharge according to the standardized process of health education path , while those in the control group were implemented with the conventional health education .
METHODS	Then the satisfaction of nursing work , hospital stays , hospitalization expenses and mastery of health knowledge of the patients in the two groups were investigated and the results were compared .
RESULTS	The satisfaction rates of nursing work of patients in the observation group and the control group were 90 % and 60 % , respectively , the difference between them was statistically significant ( 2 = 7.57 , P < 0.05 ) .
RESULTS	The average hospitals stays of the above two groups were 14.0 3.5 d and 19.0 6.8 d ( t = 2.85 , P < 0.01 ) , respectively , and the average hospitalization expenses were ( 1.5 0.5 ) thousand Yuan and ( 2.2 0.7 ) thousand Yuan ( t = 24.57 , P < 0.01 ) , respectively , both of the differences were statistically significant .
RESULTS	On the 10th day after surgery , the mastery rates of the health knowledge of the two groups were 96.7 % and 50.0 % , respectively , the difference was statistically significant ( 2 = 16.86 , P < 0.001 ) .
CONCLUSIONS	The implementation of the health education path can promote the rehabilitation of advanced schistosomiasis patients with splenomegaly , and increase the satisfaction as well as improve the mastery of the health knowledge of the patients .
CONCLUSIONS	Meanwhile , it also can cut down the hospital stays and save the hospitalization expenses .

###25270900
BACKGROUND	Cardiovascular dysfunction is common after out-of-hospital cardiac arrest as part of the postcardiac arrest syndrome , and hypothermia may pose additional impact on hemodynamics .
BACKGROUND	The aim was to investigate systemic vascular resistance index ( SVRI ) , cardiac index , and myocardial performance at a targeted temperature management of 33C ( TTM33 ) versus 36C ( TTM36 ) .
RESULTS	Single-center substudy of 171 patients included in the Target Temperature Management Trial ( TTM Trial ) randomly assigned to TTM33 or TTM36 for 24 hours after out-of-hospital cardiac arrest .
RESULTS	Mean arterial pressure 65 mm Hg and central venous pressure of 10 to 15 mm Hg were hemodynamic treatment goals .
RESULTS	Hemodynamic evaluation was performed by serial right heart catheterization and transthoracic echocardiography .
RESULTS	Primary end point was SVRI after 24 hours of cooling and secondary end points included mean SVRI , cardiac index , systolic function , and lactate levels .
RESULTS	The TTM33 group had a significant increase in SVRI compared with TTM36 ( 2595 ; 95 % confidence interval , 2422-2767 ) versus 1960 ( 95 % confidence interval , 1787-2134 ) dynes m ( 2 ) / s per cm ( 5 ) ; P < 0.0001 , respectively ) after 24 hours of cooling with an overall difference of 556 dynes m ( 2 ) / s per cm ( 5 ) ( P ( group ) < 0.0001 ) .
RESULTS	TTM33 was associated with decreased cardiac index ( -0.4 L/min per m ( 2 ) ; P ( group ) < 0.0001 ) , decreased heart rate ( P ( group ) = 0.01 ) , and stroke volume index ( P ( group ) = 0.004 ) compared with TTM36 .
RESULTS	Left ventricular ejection fraction ( P = 0.39 ) and peak systolic myocardial velocity ( P = 0.62 ) did not differ between TTM groups .
RESULTS	Lactate levels were significantly higher in the TTM33 group ( P = 0.0008 ) .
CONCLUSIONS	Targeted temperature management at 33C with target mean arterial pressure 65 mm Hg is associated with increased SVRI and lower cardiac index because of lower heart rate with unaffected left ventricular systolic function compared with 36C .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01020916 .

###25421252
BACKGROUND	Locally advanced rectal cancer ( LARC ) is a heterogeneous group of tumors where a risk-adapted therapeutic strategy is needed .
BACKGROUND	Short-course radiotherapy ( SCRT ) is a more convenient option for LARC patients than preoperative long-course RT plus capecitabine .
BACKGROUND	Histone-deacetylase inhibitors ( HDACi ) have shown activity in combination with RT and chemotherapy in the treatment of solid tumors .
BACKGROUND	Valproic acid ( VPA ) is an anti-epileptic drug with HDACi and anticancer activity .
BACKGROUND	In preclinical studies , our group showed that the addition of HDACi , including VPA , to capecitabine produces synergistic antitumour effects by up-regulating thymidine phosphorylase ( TP ) , the key enzyme converting capecitabine to 5-FU , and by downregulating thymidylate synthase ( TS ) , the 5-FU target .
METHODS	Two parallel phase-1 studies will assess the safety of preoperative SCRT ( 5 fractions each of 5Gy , on days 1 to 5 ) combined with ( a ) capecitabine alone ( increasing dose levels : 500-825mg / m2/bid ) , on days 1-21 , or ( b ) capecitabine as above plus VPA ( oral daily day -14 to 21 , with an intra-patient titration for a target serum level of 50-100 microg/ml ) followed by surgery 8weeks after the end of SCRT , in low-moderate risk RC patients .
METHODS	Also , a randomized phase-2 study will be performed to explore whether the addition of VPA and/or capecitabine to preoperative SCRT might increase pathologic complete tumor regression ( TRG1 ) rate .
METHODS	A sample size of 86 patients ( 21-22 / arm ) was calculated under the hypothesis that the addition of capecitabine or VPA to SCRT can improve the TRG1 rate from 5 % to 20 % , with one-sided alpha = 0.10 and 80 % power.Several biomarkers will be evaluated comparing normal mucosa with tumor ( TP , TS , VEGF , RAD51 , XRCC1 , Histones/proteins acetylation , HDAC isoforms ) and on blood samples ( polymorphisms of DPD , TS , XRCC1 , GSTP1 , RAD51 and XRCC3 , circulating endothelial and progenitors cells ; PBMCs-Histones/proteins acetylation ) .
METHODS	Tumor metabolism will be measured by 18FDG-PET at baseline and 15days after the beginning of SCRT .
CONCLUSIONS	This project aims to improve the efficacy of preoperative treatment of LARC and to decrease the inconvenience and the cost of standard long-course RT. .
CONCLUSIONS	Correlative studies could identify both prognostic and predictive biomarkers and could add new insight in the mechanism of interaction between VPA , capecitabine and RT.EudraCT Number : 2012-002831-28 .
BACKGROUND	ClinicalTrials.gov number , NCT01898104 .

###25856791
BACKGROUND	Chronic obstructive pulmonary disease ( COPD ) generates a high burden on health care , and hospital admissions represent a substantial proportion of the overall costs of the disease .
BACKGROUND	Integrated care ( IC ) has shown efficacy to reduce hospitalisations in COPD patients at a pilot level .
BACKGROUND	Deployment strategies for IC services require assessment of effectiveness at the health care system level .
OBJECTIVE	The aim of this study was to explore the effectiveness of a community-based IC service in preventing hospitalisations and emergency department ( ED ) visits in stable frail COPD patients .
METHODS	From April to December 2005 , 155 frail community-dwelling COPD patients were randomly allocated either to IC ( n = 76 , age 73 ( 8 ) years , forced expiratory volume during the first second , FEV1 41 ( 19 ) % predicted ) or usual care ( n = 84 , age 75 ( 9 ) years , FEV1 44 ( 20 ) % predicted ) and followed up for 12 months .
METHODS	The IC intervention consisted of the following : ( a ) patient 's empowerment for self-management ; ( b ) an individualised care plan ; ( c ) access to a call centre ; and ( d ) coordination between the levels of care .
METHODS	Thereafter , hospital admissions , ED visits and mortality were monitored for 6 years .
RESULTS	IC enhanced self-management ( P = 0.02 ) , reduced anxiety-depression ( P = 0.001 ) and improved health-related quality of life ( P = 0.02 ) .
RESULTS	IC reduced both ED visits ( P = 0.02 ) and mortality ( P = 0.03 ) but not hospital admission .
RESULTS	No differences between the two groups were seen after 6 years .
CONCLUSIONS	The intervention improved clinical outcomes including survival and decreased the ED visits , but it did not reduce hospital admissions .
CONCLUSIONS	The study facilitated the identification of two key requirements for adoption of IC services in the community : appropriate risk stratification of patients , and preparation of the community-based work force .

###24784909
BACKGROUND	The objective of this study was to assess change in sitting and physical activity behavior in response to a workplace intervention to disrupt prolonged sitting time .
METHODS	Sixty office workers were randomized to either a Stand group ( n = 29 ) , which received hourly prompts ( computer-based and wrist-worn ) to stand up , or a Step group ( n = 31 ) , which received the same hourly prompts and an additional prompt to walk 100 steps or more upon standing .
METHODS	An ActivPAL monitor was used to assess sitting and physical activity behavior on the same 3 consecutive workdays during baseline and intervention periods .
METHODS	Mixed-effect models with random intercepts and random slopes for time were performed to assess change between groups and across time .
RESULTS	Both groups significantly reduced duration of average sitting bouts ( Stand group , by 16 % ; Step group , by 19 % ) and the number of sitting bouts of 60 minutes or more ( Step group , by 36 % ; Stand group , by 54 % ) .
RESULTS	The Stand group significantly reduced total sitting time ( by 6.6 % ) , duration of the longest sitting bout ( by 29 % ) , and number of sitting bouts of 30 minutes or more ( by 13 % ) and increased the number of sit-to-stand transitions ( by 15 % ) and standing time ( by 23 % ) .
RESULTS	Stepping time significantly increased in the Stand ( by 14 % ) and Step ( by 29 % ) groups , but only the Step group significantly increased ( by 35 % ) the number of steps per workday .
RESULTS	Differences in changes from baseline to intervention between groups were not significant for any outcome .
CONCLUSIONS	Interventions that focus on disrupting sitting time only in the workplace may result in less sitting .
CONCLUSIONS	When sitting time disruptions are paired with a physical activity prompt , people may be more likely to increase their workday physical activity , but the effect on sitting time may be attenuated .

###24681078
OBJECTIVE	We compared the ability of biennial fecal immunochemical testing ( FIT ) and one-time sigmoidoscopy to detect colon side-specific advanced neoplasms in a population-based , multicenter , nationwide , randomized controlled trial .
METHODS	We identified asymptomatic men and women , 50-69 years old , through community health registries and randomly assigned them to groups that received a single colonoscopy examination or biennial FIT .
METHODS	Sigmoidoscopy yield was simulated from results obtained from the colonoscopy group , according to the criteria proposed in the UK Flexible Sigmoidoscopy Trial for colonoscopy referral .
METHODS	Patients who underwent FIT and were found to have 75 ng hemoglobin/mL were referred for colonoscopy .
METHODS	Data were analyzed from 5059 subjects in the colonoscopy group and 10,507 in the FIT group .
METHODS	The main outcome was rate of detection of any advanced neoplasm proximal to the splenic flexure .
RESULTS	Advanced neoplasms were detected in 317 subjects ( 6.3 % ) in the sigmoidoscopy simulation group compared with 288 ( 2.7 % ) in the FIT group ( odds ratio for sigmoidoscopy , 2.29 ; 95 % confidence interval , 1.93-2 .70 ; P = .0001 ) .
RESULTS	Sigmoidoscopy also detected advanced distal neoplasia in a higher percentage of patients than FIT ( odds ratio , 2.61 ; 95 % confidence interval , 2.20-3 .10 ; P = .0001 ) .
RESULTS	The methods did not differ significantly in identifying patients with advanced proximal neoplasms ( odds ratio , 1.17 ; 95 % confidence interval , 0.78-1 .76 ; P = .44 ) .
RESULTS	This was probably due to the lower performance of both strategies in detecting patients with proximal lesions ( sigmoidoscopy detected these in 19.1 % of patients and FIT in 14.9 % of patients ) vs distal ones ( sigmoidoscopy detected these in 86.8 % of patients and FIT in 33.5 % of patients ) .
RESULTS	Sigmoidoscopy , but not FIT , detected proximal lesions in lower percentages of women ( especially those 50-59 years old ) than men .
CONCLUSIONS	Sigmoidoscopy and FIT have similar limitations in detecting advanced proximal neoplasms , which depend on patients ' characteristics ; sigmoidoscopy underperforms for women 50-59 years old .
CONCLUSIONS	Screening strategies should be designed on the basis of target population to increase effectiveness and cost-effectiveness .
CONCLUSIONS	ClinicalTrials.gov number : NCT00906997 .

###25157500
OBJECTIVE	The authors evaluated whether an obstetrics-gynecology clinic-based collaborative depression care intervention is differentially effective compared with usual care for socially disadvantaged women with either no health insurance or with public coverage compared with those with commercial insurance .
METHODS	The study was a two-site randomized controlled trial with an 18-month follow-up .
METHODS	Women were recruited who screened positive ( a score of at least 10 on the Patient Health Questionnaire-9 ) and met criteria for major depression or dysthymia .
METHODS	The authors tested whether insurance status had a differential effect on continuous depression outcomes between the intervention and usual care over 18 months .
METHODS	They also assessed differences between the intervention and usual care in quality of depression care and dichotomous clinical outcomes ( a decrease of at least 50 % in depressive symptom severity and patient-rated improvement on the Patient Global Improvement Scale ) .
RESULTS	The treatment effect was significantly associated with insurance status .
RESULTS	Compared with patients with commercial insurance , those with no insurance or with public coverage had greater recovery from depression symptoms with collaborative care than with usual care over the 18-month follow-up period .
RESULTS	At the 12-month follow-up , the effect size for depression improvement compared with usual care among women with no insurance or with public coverage was 0.81 ( 95 % CI = 0.41 , 0.95 ) , whereas it was 0.39 ( 95 % CI = -0.08 , 0.84 ) for women with commercial insurance .
CONCLUSIONS	Collaborative depression care adapted to obstetrics-gynecology settings had a greater impact on depression outcomes for socially disadvantaged women with no insurance or with public coverage compared with women with commercial insurance .

###24932624
OBJECTIVE	To assess the applicability of the Peak Nasal Inspiratory Flow ( PNIF ) curves in follow-up of children in the treatment of allergic rhinitis .
METHODS	Prospective study of 40 patients with AR , grouped in corticosteroid spray versus physiological saline solution use .
METHODS	Follow up for 10 weeks through clinical score and PNIF percentages in relation to the reference curves , with was-out at week 8 .
METHODS	Statistical assessment of the effect of treatment on variation of PNIF and clinical score was calculated by ANOVA model and Multiple Comparison of Means Test - Least Significant Difference .
RESULTS	There was a statistically significant influence of the group , time and interaction between time and group on PNIF percentages .
RESULTS	Throughout follow up , patients from the treatment group had mean PNIF percentages significantly higher than the placebo group .
RESULTS	Clinical score results also demonstrated a statistically significant influence between the groups , time and interaction between time and group .
CONCLUSIONS	Increase in PNIF percentage values observed in children treated with intranasal corticosteroids revealed the applicability of PNIF curves in their follow up .

###24518194
OBJECTIVE	Regular maternal exercise may play an important role in the management of gestational diabetes mellitus ( GDM ) , yet specific exercise guidelines to achieve glycemic control have not been established .
OBJECTIVE	Furthermore , many women remain sedentary during pregnancy because of perceived barriers to exercise participation .
OBJECTIVE	This study examined the effectiveness of a home-based cycling program commenced upon diagnosis of GDM on daily fasting and postprandial blood glucose levels , glycosylated hemoglobin ( HbA1c ) , and the response of glucose and insulin to a 75-g oral glucose load .
METHODS	Forty sedentary women ( 28.8 0.9 wk of gestation ) were randomized to either home-based exercise training in combination with conventional management ( EX , n = 20 ) or to conventional management alone ( CON , n = 20 ) until week 34 of pregnancy .
RESULTS	Mean compliance to the supervised exercise training was 96 % , and no adverse effects were reported .
RESULTS	Capillary glucose concentration was acutely reduced in response to each cycling session ( 6.3 0.8 mM to 4.9 0.7 mM , P < 0.001 ) .
RESULTS	Overall , the EX group had lower mean daily postprandial glucose concentrations throughout the intervention compared with that in the CON group ( P < 0.05 ) despite consuming a greater proportion of dietary carbohydrate ( P < 0.05 ) .
RESULTS	No differences were observed between groups with respect to HbA1c or the glucose and insulin response to oral glucose ingestion postintervention ( P > 0.05 ) .
CONCLUSIONS	A home-based cycling program may help to maintain daily postprandial normoglycemia in women with diet-controlled GDM .

###24996030
OBJECTIVE	It is necessary to screen people at high risk for proteinuria with an economical , reliable and convenient method .
OBJECTIVE	The aim of this study is to establish a new approach to predict 24h urine protein ( 24h UP ) by routine laboratory assays .
METHODS	Five centres were included and a total of 4211 hospitalized patients were enrolled .
METHODS	All samples were assayed for dipstick protein ( DSP ) , specific gravity ( SG ) , 24h UP and serum albumin ( ALB ) simultaneously .
METHODS	4211 patients were randomly divided into two groups for establishing and testing the equations .
METHODS	Equations were built by multiple log-linear regressions .
RESULTS	( i ) DSP is significantly correlated to 24h UP in a logarithmic pattern ; ( ii ) SG interprets 24h UP for specific DSP ; ( iii ) Equation 1 = 0.20310 ( dummy-variable F ) [ 100 ( SG-1 ) ] ( -0.470 ) ; and ( iv ) Equation 2 = 13.36610 ( dummy-variable F ) [ 100 ( SG-1 ) ] ( -0.547 ) [ ALB ( g/L ) ] ( -1.130 ) The dummy-variable F had a point-to-point accordance to DSP ( detailed in text ) .
CONCLUSIONS	Combination of DSP and SG can interpret normal-range proteinuria well , and helped by ALB , their interpretation for macro proteinuria is much improved .
CONCLUSIONS	It is dependable and economical for routine urinalysis to evaluate pathological proteinuria by equation .

###25133997
OBJECTIVE	The purpose of this study was to compare the effects of two different resistance exercise protocols on self-reported disability , fear avoidance beliefs , pain catastrophizing , and back pain symptoms in obese , older adults with low back pain ( LBP ) .
METHODS	Obese adults ( n = 49 , 60-85 yr ) with chronic LBP were randomized into a total body resistance exercise intervention ( TOTRX ) , lumbar extensor exercise intervention ( LEXT ) , or a control group ( CON ) .
METHODS	Main outcomes included perceived disability ( Oswestry Disability Index , Roland Morris Disability Questionnaire ) .
METHODS	Psychosocial measures included the Fear Avoidance Beliefs survey , Tampa Scale of Kinesiophobia , and Pain Catastrophizing Scale .
METHODS	LBP severity was measured during three functional tasks : walking , stair climbing , and chair rise using an 11-point numerical pain rating scale .
RESULTS	The TOTRX group had greater reductions in self-reported disability scores due to back pain ( Oswestry Disability Index , Roland Morris Disability Questionnaire ) compared with those in the LEXT ( P < 0.05 ) .
RESULTS	The Pain Catastrophizing Scale scores decreased in the TOTRX group compared with that in the CON group by month 4 ( 64.3 % vs 4.8 % , P < 0.05 ) .
RESULTS	Pain severity during chair rise activity and walking was decreased in both the LEXT and TOTRX groups relative to the CON group .
CONCLUSIONS	Greater reductions in perceived disability due to LBP can be achieved with TOTRX compared with those achieved with LEXT .
CONCLUSIONS	Pain catastrophizing and pain severity decreased most with TOTRX .
CONCLUSIONS	The positive change in psychological outlook may assist obese , older adults with chronic back pain in reconsidering the harmfulness of the pain and facilitate regular participation in other exercise programs .

###24481688
BACKGROUND	Suboptimal vitamin B status might affect cognitive performance in early childhood .
BACKGROUND	We tested the hypothesis that short-term supplementation with folic acid and selected B vitamins improves cognitive function in healthy children in a population with relatively low folate status .
METHODS	We screened 1,002 kindergarten children for suboptimal folate status by assessing the total urinary para-aminobenzoylglutamate excretion .
METHODS	Two hundred and fifty low ranking subjects were recruited into a double blind , randomized , controlled trial to receive daily a sachet containing 220 g folic acid , 1.1 mg vitamin B2 , 0.73 mg B6 , 1.2 g B12 and 130 mg calcium , or calcium only for 3 months .
METHODS	Primary outcomes were changes in verbal IQ , short-term memory and processing speed between baseline and study end .
METHODS	Secondary outcomes were urinary markers of folate and vitamin B12 status , acetyl-para-aminobenzoylglutamate and methylmalonic acid , respectively , and , in a subgroup of 120 participants , blood folate and plasma homocysteine .
RESULTS	Pre - and post-intervention cognitive measurements were completed by 115 children in the intervention and 122 in the control group .
RESULTS	Compared to control , median blood folate increased by about 50 % ( P for difference , P < 0.0001 ) .
RESULTS	Homocysteine decreased by 1.1 mol/L compared to baseline , no change was seen in the control group ( P for difference P < 0.0001 ) and acetyl-para-aminobenzoylglutamate was 4 nmol/mmol higher compared to control at the end of the intervention ( P < 0.0001 ) .
RESULTS	We found no relevant differences between the groups for the cognitive measures .
CONCLUSIONS	Short-term improvement of folate and homocysteine status in healthy children does not appear to affect cognitive performance .

###24450612
OBJECTIVE	In 2005 the American College of Surgeons passed a mandate requiring that level I trauma centers have mechanisms to identify and intervene with problem drinkers .
OBJECTIVE	The aim of this investigation was to determine if a multi-level trauma center intervention targeting both providers and patients would lead to higher-quality alcohol screening and brief intervention ( SBI ) when compared with trauma center mandate compliance without implementation enhancements .
METHODS	Cluster randomized trial in which intervention site ( site n = 10 , patient n = 409 ) providers received 1-day workshop training on evidence-based motivational interviewing ( MI ) alcohol interventions and four 30-minute feedback and coaching sessions ; control sites ( site n = 10 , patient n = 469 ) implemented the mandate without study team training enhancements .
METHODS	Trauma centers in the United States of America .
METHODS	A total of 878 blood alcohol-positive in-patients with and without traumatic brain injury ( TBI ) .
METHODS	MI skills of providers were assessed with fidelity coded standardized patient interviews .
METHODS	All patients were interviewed at baseline and 6 - and 12-months post-injury with the Alcohol Use Disorders Identification Test ( AUDIT ) .
RESULTS	Intervention site providers consistently demonstrated enhanced MI skills compared with control providers .
RESULTS	Intervention patients demonstrated an 8 % reduction in AUDIT hazardous drinking relative to controls over the course of the year after injury ( relative risk = 0.88 , 95 % , confidence interval = 0.79 , 0.98 ) .
RESULTS	Intervention patients were more likely to demonstrate improvements in alcohol use problems in the absence of traumatic brain injury ( TBI ) ( P = 0.002 ) .
CONCLUSIONS	Trauma center providers can be trained to deliver higher-quality alcohol screening and brief intervention ( SBI ) than untrained providers , which is associated with modest reductions in alcohol use problems , particularly among patients without TBI .

###24508207
BACKGROUND	Our group previously showed that colchicine treatment is associated with decreased early recurrence rate after ablation for atrial fibrillation ( AF ) .
OBJECTIVE	The purpose of this study was to test the mid-term efficacy of colchicine in reducing AF recurrences after a single procedure of pulmonary vein isolation in patients with paroxysmal AF .
OBJECTIVE	Assessment of quality-of-life ( QOL ) changes was a secondary objective .
METHODS	Patients with paroxysmal AF who were scheduled for ablation were randomized to a 3-month course of colchicine 0.5 mg twice daily or placebo and were followed for a median of 15 months ( with a 3-month blanking period ) .
METHODS	QOL was assessed with a general-purpose health-related QOL tool ( 26-item World Health Organization QOL questionnaire ) at baseline and after 3 and 12 months .
RESULTS	Two hundred twenty-three randomized patients underwent ablation , and 206 patients were available for analysis ( 144 male , age 62.2 5.8 years ) .
RESULTS	AF recurrence rate in the colchicine group was 31.1 % ( 32/103 ) vs 49.5 % ( 51/103 ) in the control group ( P = .010 ) , translated in a relative risk reduction of 37 % ( odds ratio 0.46 , 95 % confidence interval 0.26-0 .81 ) .
RESULTS	The number needed to treat was 6 ( 95 % confidence interval 3.2-19 .8 ) .
RESULTS	Physical domain QOL scores at 12 months were 63.6 13.8 in the colchicine group and 52.5 18.1 in controls , whereas psychological domain scores were 56.1 13.7 vs 44.7 17.3 , respectively ( P < .001 , for both ) .
CONCLUSIONS	Colchicine treatment after pulmonary vein isolation for paroxysmal AF is associated with lower AF recurrence rates after a single procedure .
CONCLUSIONS	This reduction is accompanied by corresponding improvements in physical and psychological health-related QOL scores .

###24621799
OBJECTIVE	The aim of this study was to investigate whether effective suppression of central sleep apnea ( CSA ) by adaptive servo-ventilation ( ASV ) improves underlying cardiac dysfunction among patients with heart failure ( HF ) in whom CSA was not effectively suppressed by continuous positive airway pressure ( CPAP ) .
BACKGROUND	The presence of CSA in HF is associated with a poor prognosis , whereas CPAP treatment improves HF .
BACKGROUND	However , in a large-scale trial , CPAP failed to improve survival , probably due to insufficient CSA suppression .
BACKGROUND	Recently , ASV was reported as the most effective alternative to CSA suppression .
BACKGROUND	However , the effects of sufficient CSA suppression by ASV on cardiac function are unknown .
METHODS	Patients with New York Heart Association classII HF , left ventricular ejection fraction < 50 % , and CSA that was unsuppressed ( defined as an apnea-hypopnea index15 ) despite3 months of CPAP were randomly assigned to receive ASV in either CPAP mode or ASV mode .
RESULTS	Of 23 patients enrolled , 12 were assigned to the ASV-mode group and 11 were assigned to the CPAP-mode group .
RESULTS	Three months after randomization , the ASV mode was significantly more effective in suppressing the apnea-hypopnea index ( from 25.0 6.9 events/h to 2.0 1.4 events/h ; p < 0.001 ) compared to the CPAP mode .
RESULTS	Compliance wassigni-ficantly greater with the ASV mode than with the CPAP mode .
RESULTS	Improvement in left ventricular ejection fraction was greater with the ASV mode ( 32.0 7.9 % to 37.8 9.1 % ; p < 0.001 ) than with the CPAPmode .
CONCLUSIONS	Patients with HF and unsuppressed CSA despite receiving CPAP may receive additional benefit by having CPAP replaced with ASV .
CONCLUSIONS	Additionally , effective suppression of CSA may improve cardiac function in HF patients .

###24706299
OBJECTIVE	The efficacy and safety of a single-dose of Montelukast sodium for treating virus-related infantile wheezing are investigated in this study .
METHODS	A prospective , open , randomized , controlled study was carried out on 595 cases of infants who exhibited wheezing after a respiratory syncytial virus infection .
METHODS	Treatment with Montelukast sodium was provided over the course of 12 weeks .
METHODS	The clinical efficacy of Montelukast sodium was determined based on the clinical symptom score , tidal breathing lung function , and short-acting bronchodilator usage , as well as infantile asthma diagnosis rate change at the 4th and 12th week after the administration of the treatment .
METHODS	The adverse reactions were also observed , and a control group was set .
METHODS	The mean age of the 595 patients with infantile wheezing was 10.82 months 4.22 months .
METHODS	Among these patients , 45.9 % ( 273 out of 595 ) had a family history of asthma , 30.6 % ( 182 out of 595 ) had allergic rhinitis , 23.9 % ( 142 out of 595 ) increased peripheral blood eosinophilia , 6.1 % ( 36 out of 595 ) exhibited total IgE increase , 40.0 % ( 238 out of 595 ) had a recurrent history of wheezing , and 64.0 % ( 381 out of 595 ) had a family history of eczema .
RESULTS	After 12 weeks of treatment , the clinical symptom scores significantly improved .
RESULTS	Significant differences in the cough , wheezing , and motility scores were observed before and after the treatment ( p < 0.05 ) .
RESULTS	TPTEF/TE and VPEF/VE significantly improved ( p < 0.05 ) after the treatment .
RESULTS	The asthma diagnosis rate was 9.6 % ( 57 out of 595 ) .
RESULTS	At four weeks after treatment , various indicators correspondingly improved .
RESULTS	Twenty-nine ( 4.9 % ) patients exhibited adverse reactions , 55.2 % exhibited excitation , 20.7 % suffered from insomnia , 10.3 % had headaches , 3.4 % had erythra , 3.4 % suffered from abdominal pain , and 3.4 % exhibited an increased glutamic-pyruvate transaminase level .
RESULTS	The symptoms of eczema were relieved to some extent , and the symptoms of rhinitis became less serious .
RESULTS	Significant differences were observed in the number of wheezing attacks , annual number of days hospitalized , annual number of days when 2AG was utilized , and lung function improvement ( p < 0.05 ) .
CONCLUSIONS	Montelukast sodium is clinically effective in treating virus-related wheezing , and clinical application for 4 weeks to 12 weeks can effectively relieve the symptoms of wheezing , improve lung function , and reduce the incidence rate of infantile asthma .
CONCLUSIONS	Montelukast sodium also causes few adverse reactions .

###26032174
BACKGROUND	Simulators have been widely used to train operational skills in urology , how to improve its effectiveness deserves further investigation .
BACKGROUND	In this paper , we evaluated training using a novel transparent anatomic simulator , an opaque model or no simulator training , with regard to post-training ureteroscopy and cystoscopy proficiency .
METHODS	Anatomically correct transparent and non-transparent endourological simulators were fabricated .
METHODS	Ten experienced urologists provided a preliminary evaluation of the models as teaching tools .
METHODS	36 first-year medical students underwent identical theoretical training and a 50-point examination of theoretical knowledge .
METHODS	The students were randomly assigned to receive training with the transparent simulator ( Group 1 ) , the non-transparent simulator ( Group 2 ) or detailed verbal instruction only ( Group 3 ) .
METHODS	12 days after the training session , the trainees ' skills at ureteral stent insertion and removal were evaluated using the Uro-Scopic Trainer and rated on an Objective Structured Assessment of Technical Skills ( OSATS ) scale .
RESULTS	The new simulators were successfully fabricated in accordance with the design parameters .
RESULTS	Of the ten urologists invited to evaluate the devices , 100 % rated the devices as anatomically accurate , 90 % thought both models were easy to use and 80 % thought they were good ureteroscopy and cystoscopy training tools .
RESULTS	The scores on the theoretical knowledge test were comparable among the training groups , and all students were able to perform ureteral stent insertion and removal .
RESULTS	The mean OSATS scores of groups 1 , 2 and 3 were 21.833.64 , 18.504.03 and 15.582.23 points , respectively , ( p = 0.001 ) .
CONCLUSIONS	Simulator training allowed students to achieve higher ureteroscopic and cystoscopic proficiency , and transparent simulators were more effective than non-transparent simulators .

###25290792
OBJECTIVE	To report a subgroup analysis comparing safety and effectiveness outcomes in Japanese and non-Japanese patients as part of a prospective , multinational , randomized controlled trial ( ClinicalTrials.gov identifier NCT00120406 ) evaluating a paclitaxel-coated drug-eluting stent ( DES ) compared to percutaneous transluminal angioplasty ( PTA ) for treating peripheral artery disease .
METHODS	Patients were randomly assigned to primary DES or PTA .
METHODS	In the Japanese cohort , 27 patients ( 21 men ; mean age 71.29.6 years ) were randomized to PTA and 25 patients ( 19 men ; mean age 69.810.2 years ) to primary DES .
METHODS	In the non-Japanese cohort , 211 patients ( 131 men ; mean age 67.310.6 years ) were randomized to PTA and 211 patients ( 136 men ; mean age 67.69.5 years ) to primary DES .
METHODS	Outcome measures included event-free survival ( EFS ) , freedom from target lesion revascularization ( TLR ) , patency , stent fracture , and sustained clinical benefit through 2 years .
RESULTS	Safety and effectiveness outcomes were similar in the Japanese and non-Japanese cohorts , although the outcomes in the Japanese cohort treated with primary DES were numerically better .
RESULTS	In the DES group , the 2-year EFS was 92.0 % vs. 85.0 % ( p = 0.61 ) , freedom from TLR was 96.0 % vs. 85.5 % ( p = 0.55 ) , primary patency was 80.0 % vs. 74.3 % ( p = 0.61 ) , and clinical benefit was sustained in 88.5 % vs. 80.5 % of patients ( p = 0.31 ) in the Japanese and non-Japanese cohorts , respectively .
RESULTS	Stent fractures were seen in 4 of 457 stents at 12 months : 3 in the Japanese cohort and 1 in the non-Japanese cohort .
CONCLUSIONS	The subgroup analysis comparing Japanese and non-Japanese patients supports the safety and effectiveness of the paclitaxel-coated DES in Japanese patients with stenotic lesions in the femoropopliteal arteries .
CONCLUSIONS	The lack of major differences associated with ethnicity in these 2-year outcomes supports the validity and value of multinational clinical trials .

###24293762
OBJECTIVE	To test the hypothesis that rapid eye movement ( REM ) sleep contributes to the consolidation of new memories , whereas non-rapid eye movement ( NREM ) sleep contributes to the prevention of retroactive interference .
METHODS	Randomized , crossover study .
METHODS	Two sessions of either a morning nap or wakefulness .
METHODS	Twenty-five healthy young adults .
METHODS	Declarative learning of word pairs followed by a nap or a wake interval , then learning of interfering word pairs and delayed recall of list A.
RESULTS	After a restricted night ( 24:00 -06:00 ) , participants learned a list of word pairs ( list A ) .
RESULTS	They were then required to either take a nap or stay awake during 45 min , after which they learned a second list of word pairs ( list B ) and then had to recall list A. Fifty percent of word pairs in list B shared the first word with list A , resulting in interference .
RESULTS	Ten subjects exhibited REM sleep whereas 13 subjects exhibited NREM stage 3 ( N3 ) sleep .
RESULTS	An interference effect was observed in the nap but not in the wake condition .
RESULTS	In post-learning naps , N3 sleep was associated with a reduced interference effect , which was not the case for REM sleep .
RESULTS	Moreover , participants exhibiting N3 sleep in the post-learning nap condition also showed a reduced interference effect in the wake condition , suggesting a higher protection ability against interference .
CONCLUSIONS	Our results partly support the hypothesis that non-rapid eye movement sleep contributes in protecting novel memories against interference .
CONCLUSIONS	However , rapid eye movement sleep-related consolidation is not evidenced .

###24709495
OBJECTIVE	To investigate effects of two doses of dexmedetomidine ( Dex ) on the recovery quality from general anesthesia undergoing thyroidectomy .
METHODS	A prospective randomized controlled double-blind trial was conducted in 90 patients admitted to Shengjing Hospital of China Medical University who were scheduled for thyroidectomy .
METHODS	They were randomly divided into three groups : group D0 .4 received Dex 0.4 g/kg intravenously , group D0 .8 received Dex 0.8 g/kg intravenously , and control group with same volume of normal saline .
METHODS	There were 30 patients in each group , and all the patients received the above drug or saline 30 minutes after intubation .
METHODS	The heart rate ( HR ) , systolic blood pressure ( SBP ) and diastolic blood pressure ( DBP ) were recorded before Dex administration , at the end of surgery , time of eye opening and extubation , and 10 minutes after extubation .
METHODS	Time of eye opening after surgery and time of extubation after eye opening were recorded .
METHODS	End-tidal partial pressure of carbon dioxide ( PETCO2 ) before and after operation as well as restlessness score ( RS ) , Ramsay sedative score , and visual analogue pain scale ( VAS ) scores at 10 minutes after extubation were recorded .
METHODS	Events during extubation including cough , nausea and vomiting , respiratory depression were also recorded .
RESULTS	( 1 ) Compared with control group , in D0 .4 and D0 .8 groups incidence of lowering of HR , SBP and DBP was lower at time of eye opening and extubation , and 10 minutes after extubation .
RESULTS	Compared with D0 .4 group , D0 .8 group had lower HR at the time of extubation and 10 minutes after extubation , SBP was lower at the time of eye opening and extubation , and lower DBP at the time of eye opening .
RESULTS	( 2 ) D0 .4 and D0 .8 groups showed lower RS and VAS scores than those of control group , Ramsay sedative score in groups D0 .4 and D0 .8 was higher than that in control group ( RS : 1.400.51 , 1.200.42 vs. 1.900.56 ; VAS : 1.500.52 , 0.800.63 vs. 2.500.52 ; Ramsay : 2.100.56 , 2.400.51 vs. 1.600.51 , P < 0.05 or P < 0.01 ) , and VAS score in group D0 .8 was lower than that in D0 .4 group ( P < 0.01 ) .
RESULTS	The time of eye opening and extubation were longer in group D0 .8 as compared with those in control and D0 .4 groups ( 12.501.08 minutes vs. 10.501.58 minutes , 10.401.26 minutes ; 15.000.94 minutes vs. 13.001.63 minutes , 12.801.13 minutes , P < 0.05 or P < 0.01 ) , but there was no significant difference between the latter two groups .
RESULTS	No significant difference in PETCO2 was found among three groups before and after surgery .
RESULTS	( 3 ) The incidence rate of cough , nausea and vomiting in control group ( 16.7 % , 13.3 % ) were significantly higher than those in groups D0 .4 ( 3.3 % , 0 ) and D0 .8 ( 0 , 0 ) .
RESULTS	There was no respiratory depression in the three groups .
CONCLUSIONS	Adjunctive infusion of Dex 0.4 g/kg at 30 minutes after anesthesia induction was recommended as it may result in more steady hemodynamics , with shorter recovery time and extubation time after thyroidectomy .

###24573971
OBJECTIVE	To investigate the efficacy of pretreatment with cisatracurium for prevention of pain associated with propofol injection , and compare its efficacy with that of lidocaine .
METHODS	Patients undergoing general anaesthesia were randomized to receive normal saline ( control group ) , lidocaine ( 0.5 mg/kg ) , 0.03 mg/kg cisatracurium or 0.15 mg/kg cisatracurium .
METHODS	All drugs were administered into the largest dorsal vein of the hand with venous occlusion for 30 s , followed by propofol ( 0.5 mg/kg ) .
METHODS	Pain was evaluated using a four-point scale .
RESULTS	The incidence and severity of pain was significantly lower in the lidocaine and 0.15 mg/kg cisatracurium groups than the control and 0.03 mg/kg cisatracurium groups ( n = 50/group ) .
RESULTS	There was no significant difference between the lidocaine and 0.15 mg/kg cisatracurium groups in the incidence and severity of pain .
CONCLUSIONS	0.15 mg/kg cisatracurium effectively decreases the incidence and severity of pain induced by propofol injection without any significant complications .

###24662322
BACKGROUND	The vascular effects of acute calcitonin gene-related peptide ( CGRP ) inhibition are well described , but the effects of sustained inhibition warrant further exploration in humans .
OBJECTIVE	The objective of this article is to assess the effects of sustained CGRP inhibition on blood pressure , heart rate , and ECGs in healthy women 40 years of age .
METHODS	In this double-blind , placebo-controlled study , 31 women ( mean age = 56 ) were randomized to receive placebo or an anti-CGRP monoclonal antibody at doses up to 2000 mg .
METHODS	Participants were confined for seven days and followed for 168 days .
METHODS	Cardiac telemetry was conducted for eight hours after infusion completion .
METHODS	Hemodynamic assessments and ECGs were conducted six times during Day 1 and periodically for three months .
RESULTS	No clinically relevant changes in systolic or diastolic blood pressure , heart rate , or ECG parameters ( RR , PR , QRS , or QTcF ) were observed when comparing baseline vs. post-dose time-points or in-between groups .
RESULTS	No significant changes were seen for adjusted QTcF ( baseline subtracted and placebo and baseline subtracted ) .
RESULTS	No significant differences or relevant abnormalities were seen when comparing parameters obtained at Tmax vs. any other time-point .
CONCLUSIONS	Sustained CGRP inhibition was not associated with hemodynamic or ECG changes in a population at an increased age risk for cardiovascular events .

###24229373
BACKGROUND	Given the importance of influence networks in the implementation of evidence-based practices and interventions , it is unclear whether such networks continue to operate as sources of information and advice when they are segmented and disrupted by randomization to different implementation strategy conditions .
BACKGROUND	The present study examines the linkages across implementation strategy conditions of social influence networks of leaders of youth-serving systems in 12 California counties participating in a randomized controlled trial of community development teams ( CDTs ) to scale up use of an evidence-based practice .
METHODS	Semi-structured interviews were conducted with 38 directors , assistant directors , and program managers of county probation , mental health , and child welfare departments .
METHODS	A web-based survey collected additional quantitative data on information and advice networks of study participants .
METHODS	A mixed-methods approach to data analysis was used to create a sociometric data set ( n = 176 ) to examine linkages between treatment and standard conditions .
RESULTS	Of those network members who were affiliated with a county ( n = 137 ) , only 6 ( 4.4 % ) were directly connected to a member of the opposite implementation strategy condition ; 19 ( 13.9 % ) were connected by two steps or fewer to a member of the opposite implementation strategy condition ; 64 ( 46.7 % ) were connected by three or fewer steps to a member of the opposite implementation strategy condition .
RESULTS	Most of the indirect steps between individuals who were in different implementation strategy conditions were connections involving a third non-county organizational entity that had an important role in the trial in keeping the implementation strategy conditions separate .
RESULTS	When these entities were excluded , the CDT network exhibited fewer components and significantly higher betweenness centralization than did the standard condition network .
CONCLUSIONS	Although the integrity of the RCT in this instance was not compromised by study participant influence networks , RCT designs should consider how influence networks may extend beyond boundaries established by the randomization process in implementation studies .
BACKGROUND	NCT00880126 .

###25407798
BACKGROUND	Type 2 diabetes is a major risk factor for chronic kidney disease , which substantially increases the risk of cardiovascular disease mortality .
BACKGROUND	This Phase IIb safety study ( AleNephro ) in patients with stage 3 chronic kidney disease and type 2 diabetes , evaluated the renal effects of aleglitazar , a balanced peroxisome proliferator-activated receptor - / agonist .
METHODS	Patients were randomized to 52 weeks ' double-blind treatment with aleglitazar 150 g/day ( n = 150 ) or pioglitazone 45 mg/day ( n = 152 ) , followed by an 8-week off-treatment period .
METHODS	The primary endpoint was non-inferiority for the difference between aleglitazar and pioglitazone in percentage change in estimated glomerular filtration rate from baseline to end of follow-up .
METHODS	Secondary endpoints included change from baseline in estimated glomerular filtration rate and lipid profiles at end of treatment .
RESULTS	Mean estimated glomerular filtration rate change from baseline to end of follow-up was -2.7 % ( 95 % confidence interval : -7.7 , 2.4 ) with aleglitazar versus -3.4 % ( 95 % confidence interval : -8.5 , 1.7 ) with pioglitazone , establishing non-inferiority ( 0.77 % ; 95 % confidence interval : -4.5 , 6.0 ) .
RESULTS	Aleglitazar was associated with a 15 % decrease in estimated glomerular filtration rate versus 5.4 % with pioglitazone at end of treatment , which plateaued to 8 weeks and was not progressive .
RESULTS	Superior improvements in high-density lipoprotein cholesterol , low-density lipoprotein cholesterol and triglycerides , with similar effects on glycosylated hemoglobin were observed with aleglitazar versus pioglitazone .
RESULTS	No major safety concerns were identified .
CONCLUSIONS	The primary endpoint in AleNephro was met , indicating that in stage 3 chronic kidney disease patients with type 2 diabetes , the decrease in estimated glomerular filtration rate after 52 weeks ' treatment with aleglitazar followed by 8 weeks off-treatment was reversible and comparable ( non-inferior ) to pioglitazone .
BACKGROUND	NCT01043029 January 5 , 2010 .

###24879495
BACKGROUND	An increase in the potency of the cannabis cigarettes has been observed over the past three decades .
OBJECTIVE	In this study , we aimed to establish the impact of 9-tetrahydrocannabinol ( THC ) on the rating of subjective effects ( intensity and duration of the effects ) , up to 23 % THC potency ( 69 mg THC ) among recreational users .
METHODS	Recreational users ( N = 24 ) smoked cannabis cigarettes with four doses of THC ( placebo 29 , 49 and 69 mg of THC ) on four separate test days in a randomized , double-blind , placebo-controlled , crossover study .
METHODS	The participants filled in three different questionnaires measuring subjective effects during the exposure up to 8 h post-smoking .
METHODS	The ` high ' feeling , heart rate , blood pressure and THC serum concentrations were also regularly recorded during these 8 h.
RESULTS	THC significantly increased the high feeling , dizziness , dry-mouthed feeling , palpitations , impaired memory and concentration , and ` down ' , ` sedated ' and ` anxious ' feelings .
RESULTS	In addition , THC significantly decreased alertness , contentment and calmness .
RESULTS	A cubic relationship was observed between ` feeling the drug ' and ` wanting more ' .
RESULTS	The THC-induced decrease in ` feeling stimulated ' and increase in anxiety lasted up to 8 h post-smoking .
RESULTS	Sedation at 8 h post-smoking was increased by a factor of 5.7 with the highest THC dose , compared to the placebo .
CONCLUSIONS	This study shows a strong effect of cannabis containing high percentages of THC on the rating of subjective effects .
CONCLUSIONS	Regular users and forensic toxicologists should be aware that the THC-induced increase in ` feeling sedated ' continues longer with a 69 mg THC dose than with a 29 mg THC dose .

###25398660
OBJECTIVE	Increased levels of oxidative stress have been seen in animal models of dry eye and in the conjunctival epithelial cells of patients with Sjgren 's syndrome .
OBJECTIVE	The aims of this study were to compare the levels of oxidative stress in patients with dry eye and patients without dry eye and to evaluate the effects of treatment with preservative-free eye drops containing hyaluronic acid 0.15 % and vitamin B12 on oxidative stress and dry eye symptoms .
METHODS	Three cohorts of patients who were to undergo planned cataract surgery were enrolled : patients with dry eye randomized to either no treatment ( n = 29 ) or treatment ( n = 32 ) with hyaluronic acid/vitamin B12 eye drops , and patients without dry eye ( n = 42 ) .
METHODS	Patients were assessed by Schirmer 's type I test , fluorescein clearance test ( FCT ) , Break Up Time ( BUT ) , and Ocular Surface Disease Index ( OSDI ) .
METHODS	Lipid peroxidation , a marker of oxidative stress , was assessed by LP-CHOLOX test .
RESULTS	Compared with patients without dry eye , patients with dry eye had significantly increased levels of oxidative stress , higher OSDI and FCT scores , and significantly lower Schirmer 's test and BUT scores .
RESULTS	Treatment with eye drops containing hyaluronic acid 0.15 % and vitamin B12 was associated with significantly reduced levels of oxidative stress and OSDI and FCT scores and significantly increased Schirmer 's test and BUT scores .
CONCLUSIONS	These findings indicate that oxidative stress is associated with dry eye and that hyaluronic acid/vitamin B12 eye drops may attenuate oxidative stress and inflammation , improving dry eye symptoms .
CONCLUSIONS	Further study in controlled clinical trials is warranted .

###24913338
BACKGROUND	A recent randomized controlled trial provided preliminary evidence for the effectiveness of mindfulness based cognitive therapy ( MBCT ) for the top 10 % frequent attenders in primary care with persistent medically unexplained symptoms ( MUS ) .
BACKGROUND	This qualitative study aims to explore working mechanisms and possible barriers of MBCT in this population .
METHODS	Twelve participants of the trial were interviewed about their experiences .
METHODS	This was done before and after the MBCT course , and 12 months later .
METHODS	Written evaluations of participants and notes of participant observers were used for data-triangulation .
RESULTS	In total , 35 qualitative interviews were conducted .
RESULTS	MBCT initiated a process of change , starting with awareness of the present moment , the associated sensory experiences , thoughts and emotions and accepting rather than resisting these .
RESULTS	Participants started to recognize their own behavioral patterns and change them , thus improving self-care .
RESULTS	Self-compassion seemed to result from and facilitate this process .
RESULTS	Main barriers were concurrent social problems and the inability or unwillingness to accept symptoms .
CONCLUSIONS	MBCT can start a process of change in patients with persistent MUS .
CONCLUSIONS	Awareness and acceptance of painful symptoms and emotions are key factors in this process .
CONCLUSIONS	Change of unhelpful behavioral patterns and increased self-care and self-compassion can result from this process .

###25512454
OBJECTIVE	Treatment-emergent symptoms with adjuvant tamoxifen and aromatase inhibitors ( AIs ) have been associated with superior recurrence-free survival ( RFS ) .
OBJECTIVE	We hypothesized that MA .27 anastrozole - or exemestane-treated patients with new or worsening vasomotor and/or joint symptoms would have improved RFS .
METHODS	MA .27 randomly assigned 7,576 postmenopausal women with breast cancer to 5 years of anastrozole or exemestane .
METHODS	Patient-reported symptoms were collected using the Common Terminology Criteria for Adverse Events version 3.0 at protocol-specified baseline and 6 - and 12-month clinical visits .
METHODS	Symptoms were considered present with either vasomotor and/or joint complaints .
METHODS	Associations between symptoms and baseline patient characteristics were examined with ( 2 ) and Fisher 's exact tests .
METHODS	Subsequent effects of new or worsening symptoms on RFS were examined with landmark analyses and stratified univariable and multivariable Cox models .
METHODS	We examined the effects of 3-month symptoms arising from unplanned clinic visits as a result of severe toxicity .
RESULTS	Patients were assessable if eligible for the MA .27 trial , received some trial therapy , and had no disease recurrence at the end of a symptom assessment period ; 96 % of patients ( n = 7,306 patients ) were included at 6 months , and 96 % ( n = 7,246 ) were included at 12 months .
RESULTS	Thirty-four percent of patients had baseline symptoms .
RESULTS	For patients without baseline symptoms , 25 % and 52 % had new symptoms by 6 and 12 months , respectively .
RESULTS	Neither treatment-emergent nor baseline symptoms significantly impacted RFS ( P > .10 ) in patients with or without baseline symptoms .
CONCLUSIONS	In MA .27 , anastrozole or exemestane treatment-emergent symptoms were not associated with improved RFS .
CONCLUSIONS	Women should be supported through treatment and encouraged to remain on their AI regardless of their symptoms .

###25981908
BACKGROUND	Whether noninvasive ventilation should be administered in patients with acute hypoxemic respiratory failure is debated .
BACKGROUND	Therapy with high-flow oxygen through a nasal cannula may offer an alternative in patients with hypoxemia .
METHODS	We performed a multicenter , open-label trial in which we randomly assigned patients without hypercapnia who had acute hypoxemic respiratory failure and a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen of 300 mm Hg or less to high-flow oxygen therapy , standard oxygen therapy delivered through a face mask , or noninvasive positive-pressure ventilation .
METHODS	The primary outcome was the proportion of patients intubated at day 28 ; secondary outcomes included all-cause mortality in the intensive care unit and at 90 days and the number of ventilator-free days at day 28 .
RESULTS	A total of 310 patients were included in the analyses .
RESULTS	The intubation rate ( primary outcome ) was 38 % ( 40 of 106 patients ) in the high-flow-oxygen group , 47 % ( 44 of 94 ) in the standard group , and 50 % ( 55 of 110 ) in the noninvasive-ventilation group ( P = 0.18 for all comparisons ) .
RESULTS	The number of ventilator-free days at day 28 was significantly higher in the high-flow-oxygen group ( 248 days , vs. 2210 in the standard-oxygen group and 1912 in the noninvasive-ventilation group ; P = 0.02 for all comparisons ) .
RESULTS	The hazard ratio for death at 90 days was 2.01 ( 95 % confidence interval [ CI ] , 1.01 to 3.99 ) with standard oxygen versus high-flow oxygen ( P = 0.046 ) and 2.50 ( 95 % CI , 1.31 to 4.78 ) with noninvasive ventilation versus high-flow oxygen ( P = 0.006 ) .
CONCLUSIONS	In patients with nonhypercapnic acute hypoxemic respiratory failure , treatment with high-flow oxygen , standard oxygen , or noninvasive ventilation did not result in significantly different intubation rates .
CONCLUSIONS	There was a significant difference in favor of high-flow oxygen in 90-day mortality .
CONCLUSIONS	( Funded by the Programme Hospitalier de Recherche Clinique Interrgional 2010 of the French Ministry of Health ; FLORALI ClinicalTrials.gov number , NCT01320384 . )

###24579286
OBJECTIVE	The purpose of the study was to determine the cariostatic potential of a chewing gum containing tea polyphenol .
METHODS	A total of 157 schoolchildren aged 8-9 years were randomly allocated into three groups .
METHODS	Two groups received chewing gum with or without tea polyphenol .
METHODS	A third group did not receive any chewing gum .
METHODS	A single examiner assessed the caries status for all participates at baseline , 12 months and 24 months .
METHODS	A one-way analysis of variance ( ANOVA ) was performed to evaluate differences among the groups at each interval The Chi-square test was used to compare the caries-free rate among the three groups .
RESULTS	The mean DMFT increment was 0.17 for the polyphenol gum group , 0.60 for the control gum group , and 1.15 for the no gum group .
RESULTS	Children who chewed gum containing tea polyphenol had a significantly lower mean DMFS increment over the 24-month period than did the other two groups ( p < 0.05 ) .
RESULTS	The caries-free rate in the polyphenol gum group was significantly higher than that in the other two groups ( p < 0.05 ) after two years .
CONCLUSIONS	These findings indicated that the oral application of chewing gum with tea polyphenol has an inhibitory effect on dental caries .

###24444428
OBJECTIVE	The aim of this clinical trial was to determine the clinical and biochemical efficacy of an 810 nm diode laser as an adjunct to scaling and root planing ( SRP ) .
BACKGROUND	Lasers can achieve excellent tissue ablation with strong bactericidal and detoxification effects .
BACKGROUND	The use of lasers is one of the most promising new technical modalities for nonsurgical periodontal treatment .
BACKGROUND	However , the most effective wavelength and parameters for their use are still under investigation .
METHODS	This study was designed as a single-blinded , randomized-controlled , split-mouth clinical trial .
METHODS	Twenty-one patients ( 12 females and 9 males between 26 and 55 years of age ) , diagnosed with generalized chronic periodontitis , were included in the study .
METHODS	After initial periodontal therapy , which consisted of oral hygiene instructions and scaling , patients underwent two different treatment modalities .
METHODS	Test and control sites were chosen with coin toss randomization .
METHODS	At the test site , patients received SRP and laser treatment ; at the contralateral control site , they received SRP treatment alone .
RESULTS	Both treatment modalities resulted in significant improvements in all clinical and biochemical parameters .
RESULTS	Sites irradiated with an 810 nm diode laser using the `` hot tip '' ( 760 C ) technique showed enhanced healing in all the registered periodontal variables and interleukin ( IL ) -1 levels , compared with SRP alone .
CONCLUSIONS	Within the limitations of this study , the use of diode lasers as an adjunct to SRP produced significant improvements in clinical parameters as well as gingival crevicular fluid ( GCF ) IL-1 levels in the 6 month study period .

###25198263
OBJECTIVE	To examine day care treatment of nausea and vomiting of pregnancy compared with the traditional inpatient management of this condition .
METHODS	We conducted an open-label , single-center , randomized controlled trial to examine the differences between day care and inpatient management of pregnant women with nausea and vomiting of pregnancy .
METHODS	Primary outcome was total number of inpatient nights related to nausea and vomiting of pregnancy .
RESULTS	Ninety-eight women were randomized to initial day care management ( n = 42 ) or inpatient management ( n = 56 ) .
RESULTS	Results are calculated from the time of randomization until resolution of nausea and vomiting of pregnancy .
RESULTS	Women randomized to inpatient care experienced a median ( interquartile range ) of 2 ( 1-4 ) inpatient days compared with 0 ( 0-2 ) inpatient days for women randomized to day care ( P < .001 ) .
RESULTS	Women randomized to initial treatment as an inpatient had significantly more median total number of inpatient admissions ( one [ 1-2 ] compared with zero [ 0-1 ] admissions ; P < .001 ) compared with women randomized to day care .
RESULTS	No significant differences were observed in day care visits ( median [ interquartile range ] one [ 1-4 ] compared with two [ 1-4 ] ; P = .30 ) .
RESULTS	Women randomized to inpatient care were as satisfied with their care as those randomized to day care ( median [ interquartile range ] : 67 [ 57-69 ] compared with 63 [ 58-71 ] Client Satisfaction Questionnaire score ; P = .7 ) .
CONCLUSIONS	Day care treatment of nausea and vomiting of pregnancy reduced hospital inpatient stay and was acceptable to patients .
BACKGROUND	ISRCTN Register , http://www.isrctn.org , ISRCTN05023126 .
METHODS	: I.

###24644183
BACKGROUND	Pain during bone marrow biopsy ( BMB ) under local anaesthesia ( LA ) is reported in 70 % of patients , of whom 35 % rate the pain as severe .
BACKGROUND	Pain is experienced during both the biopsy and the marrow aspiration .
BACKGROUND	Many medical centres use conscious sedation involving benzodiazepines and/or opioids administered orally or intravenously for BMB analgesia .
BACKGROUND	Methoxyflurane ( MEOF ) is self-administered by a handheld device ( the Penthrox inhaler ) , which is licensed in Australia for the relief of pain associated with short surgical procedures .
OBJECTIVE	To evaluate the efficacy and safety of MEOF analgesia in patients with cancer undergoing BMB .
METHODS	Patients received LA plus either MEOF or placebo .
METHODS	The primary endpoint was worst pain intensity measured with the Numerical Rating Scale .
METHODS	Anxiety was assessed with the State Trait Anxiety Inventory ( STAI-Y-1 ) .
METHODS	Patients , operators and the research nurse rated global medication performance using a 5-point Likert scale .
RESULTS	Forty-nine of the 50 patients randomised to MEOF and 48 of the 50 patients randomised to placebo effectively received the allocated intervention .
RESULTS	MeanSD worst pain overall was 4.902.07 in MEOF group and 6.02.24 in placebo group ( p = 0.011 ) .
RESULTS	Worst pain during the aspiration was 3.32.0 in MEOF group and 5.02.4 in placebo group ( p < 0.001 ) .
RESULTS	49 % of patients treated with MEOF rated the medication as very good or excellent compared with 16.5 % of the patients treated with placebo ( p = 0.005 ) .
RESULTS	20.4 % of patients treated with MEOF had an adverse event ( AE ) compared with 4.2 % in the placebo arm ( p = 0.028 ) .
RESULTS	All AEs were grade 1 .
CONCLUSIONS	MEOF was safe and performed better than placebo for analgesia in BMB procedures .

###24467257
OBJECTIVE	Individuals with serious mental illness ( SMI ) are dying on average 25 years prematurely .
OBJECTIVE	The leading causes are chronic preventable diseases .
OBJECTIVE	In the context of a tobacco-treatment trial , this exploratory study examined the behavioral risk profiles of adults with SMI to identify broader interventional needs .
METHODS	Recruited from five acute inpatient psychiatry units , participants were 693 adult smokers ( recruitment rate = 76 % , 50 % male , 45 % Caucasian , age M = 39 , 49 % had income < $ 10,000 ) diagnosed with mood disorders ( 71 % ) , substance-use disorders ( 63 % ) , posttraumatic stress disorder ( 39 % ) , psychotic disorders ( 25 % ) , and attention deficit-hyperactivity disorder ( 25 % ) .
METHODS	The Staging Health Risk Assessment , the primary measure used in this study , screened for risk status and readiness to change 11 health behaviors , referencing the period prior to acute hospitalization .
RESULTS	Participants averaged 5.2 ( SD = 2.1 ) risk behaviors , including smoking ( 100 % ) , high-fat diet ( 68 % ) , inadequate fruits/vegetables ( 67 % ) , poor sleep ( 53 % ) , physical inactivity ( 52 % ) , and marijuana use ( 46 % ) .
RESULTS	The percent prepared to change ranged from 23 % for tobacco and marijuana to 76 % for depression management .
RESULTS	Latent class analysis differentiated three risk groups : the global higher risk group included patients elevated on all risk behaviors ; the global lower risk group was low on all risks ; and a mood and metabolic risk group , characterized by inactivity , unhealthy diet , sleep problems , and poor stress and depression management .
RESULTS	The global higher risk group ( 11 % of sample ) was younger , largely male , and had the greatest number of risk behaviors and mental health diagnoses ; had the most severe psychopathologies , addiction-treatment histories , and nicotine dependence ; and the lowest confidence for quitting smoking and commitment to abstinence .
CONCLUSIONS	Most smokers with SMI engaged in multiple risks .
CONCLUSIONS	Expanding targets to treat co-occurring risks and personalizing treatment to individuals ' multibehavioral profiles may increase intervention relevance , interest , and impact on health .

###24702886
BACKGROUND	Airway hyperresponsiveness ( AHR ) to indirect agents like mannitol is thought to be dependent on concurrent airway inflammation as these stimuli exert their effects via the release of bronchoconstricting mediators from inflammatory cells .
BACKGROUND	Airway inflammation correlates negatively with deep inhalation bronchoprotection against direct stimuli like methacholine .
BACKGROUND	We hypothesised that deep inhalation bronchoprotection to methacholine would be absent and airway inflammation would be present in individuals with AHR to inhaled mannitol .
METHODS	Twenty asthmatic , otherwise healthy individuals , either gender , aged 18-65 years , with a Visit 1 ( screening ) methacholine two-minute tidal breathing PC20 of 16 mg/mL or less completed the study .
METHODS	Visits 2 and 3 consisted of either mannitol or deep inhalation methacholine challenge in random order , at least 24 h apart .
METHODS	All visits were completed within a period of two weeks .
RESULTS	Eleven of the twenty participants had AHR to mannitol ( PD15 635 mg , the `` responders '' ) and nine did not ( the `` non-responders '' ) .
RESULTS	Responders did not bronchoprotect to methacholine via deep inhalation ( doubling dose shift = 0.7 ; p = 0.13 ) and had high levels of exhaled nitric oxide ( geometric mean 49 ppb ; range 16-109 ppb ) .
RESULTS	Conversely , significant deep inhalation bronchoprotection to methacholine occurred in the non-responder group ( doubling dose shift = 1.6 ; p = 0.013 ) .
RESULTS	This group also had significantly lower levels of exhaled nitric oxide ( geometric mean 23 ppb ( range 16-45 ppb ; p = 0.015 ) .
CONCLUSIONS	Deep inhalation bronchoprotection to methacholine and low levels of exhaled nitric oxide coincide with mannitol non-responsiveness in an asthmatic population .
CONCLUSIONS	Clinical Trials Registration #NCT 01642745 ( clinicaltrials.gov ) .

###25208824
BACKGROUND	Combat post-traumatic stress disorder ( PTSD ) involves significant suffering , impairments in social and occupational functioning , substance use and medical comorbidity , and increased mortality from suicide and other causes .
BACKGROUND	Many veterans continue to suffer despite current treatments .
BACKGROUND	Deep brain stimulation ( DBS ) has shown promise in refractory movement disorders , depression and obsessive-compulsive disorder , with deep brain targets chosen by integration of clinical and neuroimaging literature .
BACKGROUND	The basolateral amygdala ( BLn ) is an optimal target for high-frequency DBS in PTSD based on neurocircuitry findings from a variety of perspectives .
BACKGROUND	DBS of the BLn was validated in a rat model of PTSD by our group , and limited data from humans support the potential safety and effectiveness of BLn DBS .
METHODS	We describe the protocol design for a first-ever Phase I pilot study of bilateral BLn high-frequency DBS for six severely ill , functionally impaired combat veterans with PTSD refractory to conventional treatments .
METHODS	After implantation , patients are monitored for a month with stimulators off .
METHODS	An electroencephalographic ( EEG ) telemetry session will test safety of stimulation before randomization to staggered-onset , double-blind sham versus active stimulation for two months .
METHODS	Thereafter , patients will undergo an open-label stimulation for a total of 24 months .
METHODS	Primary efficacy outcome is a 30 % decrease in the Clinician Administered PTSD Scale ( CAPS ) total score .
METHODS	Safety outcomes include extensive assessments of psychiatric and neurologic symptoms , psychosocial function , amygdala-specific and general neuropsychological functions , and EEG changes .
METHODS	The protocol requires the veteran to have a cohabiting significant other who is willing to assist in monitoring safety and effect on social functioning .
METHODS	At baseline and after approximately one year of stimulation , trauma script-provoked 18FDG PET metabolic changes in limbic circuitry will also be evaluated .
CONCLUSIONS	While the rationale for studying DBS for PTSD is ethically and scientifically justified , the importance of the amygdaloid complex and its connections for a myriad of emotional , perceptual , behavioral , and vegetative functions requires a complex trial design in terms of outcome measures .
CONCLUSIONS	Knowledge generated from this pilot trial can be used to design future studies to determine the potential of DBS to benefit both veterans and nonveterans suffering from treatment-refractory PTSD .
BACKGROUND	PCC121657 , 19 March 2014 .

###24526257
OBJECTIVE	While propranolol is touted as superior to prednisolone for treating infantile hemangiomas ( IH ) , a randomized clinical trial ( RCT ) comparing the outcome and tolerability of these medications for symptomatic , proliferating IH has not been reported .
OBJECTIVE	To determine if oral propranolol is more efficacious and better tolerated than prednisolone in treating symptomatic , proliferating IH and to determine the feasibility of conducting a multi-institutional , RCT comparing efficacy and tolerability of both medications .
METHODS	Phase 2 , investigator-blinded , multi-institutional RCT conducted in 3 academic vascular anomalies clinics on 19 of 44 eligible infants aged between 2 weeks and 6 months .
METHODS	All participating patients had symptomatic proliferating IH treated between September 1 , 2010 , and August 1 , 2012 .
METHODS	Treatment with oral propranolol vs prednisolone ( 2.0 mg/kg/d ) until halted owing to toxic effects or clinical response .
METHODS	Primary outcome was change in IH size after 4 months of therapy .
METHODS	Secondary outcomes were response rate and frequency and severity of adverse events ( AEs ) .
RESULTS	The primary outcome showed no difference in lesion size or affected skin area after 4 months of therapy : 41 % and 1.32 mm2 for prednisolone vs 64 % and 0.55 mm2 for propranolol ( P = .12 for lesion size , and P = .56 for affected skin area ) .
RESULTS	Longitudinal analyses showed a faster response in total lesion outer dimension with prednisolone ( P = .03 ) , but this advantage over time was not noted when central clearing and outer dimension were included in the analysis ( P = .91 ) .
RESULTS	The overall frequency of AEs was similar ( 44 for prednisolone vs 32 for propranolol ) ( P = .84 ) , but prednisolone-treated participants had more grade 3 severe AEs ( 11 vs 1 ) ( P = .01 ) , particularly growth retardation resulting in size and weight below the fifth percentile .
RESULTS	Early study withdrawal owing to AEs occurred in 6 ( 75 % ) of 8 patients in the prednisolone group but 0 of 11 propranolol-treated participants .
RESULTS	The mean duration of therapy was shorter for prednisolone ( 141 vs 265 days ) , reflecting the higher rate of early withdrawals .
CONCLUSIONS	Both medications show similar efficacy for reducing the area of symptomatic , proliferating IH .
CONCLUSIONS	Although prednisolone showed a faster response rate , propranolol was better tolerated with significantly fewer severe AEs .
CONCLUSIONS	Propranolol should be the first line of therapy for symptomatic IH unless contraindicated or unless future studies demonstrate severe AEs from propranolol .
CONCLUSIONS	Recruiting participants for a phase 3 RCT would be difficult owing to safety profiles measured here and emerging trends favoring propranolol .
CONCLUSIONS	TRIAL REGISTRATION clinicaltrials.gov Identifier : NCT00967226 .

###25383451
BACKGROUND	Mammographic breast density is one of the strongest independent risk factors for developing breast cancer .
BACKGROUND	We examined the effect of exemestane and tamoxifen on breast density in Dutch postmenopausal early breast cancer patients participating in the Tamoxifen Exemestane Adjuvant Multinational ( TEAM ) trial .
METHODS	Analogue mammograms of selected TEAM participants before start , and after one and two ( and if available after three ) years of adjuvant endocrine therapy were collected centrally and reviewed .
METHODS	Study endpoints were change in breast density over time , and correlations between breast density and locoregional recurrence ( LRR ) , distance recurrence ( DR ) , and contralateral breast cancer ( CBC ) .
RESULTS	Mammograms of 378 patients ( 181 tamoxifen , 197 exemestane ) were included in the current per protocol analyses .
RESULTS	Baseline breast density was low ( breast density score < 50 % in 75 % of patients ) and not different between patients randomised to exemestane or tamoxifen ( coefficient 0.16 , standard error 0.17 ) .
RESULTS	Breast density did not change during treatment in exemestane ( p = 0.25 ) or tamoxifen users ( p = 0.59 ) .
RESULTS	No relation was observed between breast density and the occurrence of a LRR [ hazards ratio ( HR ) 0.87 , 95 % CI 0.45-1 .68 , p = 0.67 ] , a DR ( HR 1.02 , 95 % CI 0.77-1 .35 , p = 0.90 ) , or CBC ( HR 1.31 , 95 % CI 0.63-2 .72 , p = 0.48 ) .
CONCLUSIONS	The in general low breast density score in early postmenopausal breast cancer patients did not substantially change over time , and this pattern was not different between tamoxifen and exemestane users .
CONCLUSIONS	Breast density was not a predictive marker for efficacy of adjuvant endocrine therapy .

###24260180
BACKGROUND	The control arm of PATRICIA ( PApilloma TRIal against Cancer In young Adults , NCT00122681 ) was used to investigate the risk of progression from cervical HPV infection to cervical intraepithelial neoplasia ( CIN ) or clearance of infection , and associated determinants .
RESULTS	Women aged 15-25 years were enrolled .
RESULTS	A 6-month persistent HPV infection ( 6MPI ) was defined as detection of the same HPV type at two consecutive evaluations over 6 months and clearance as 2 type-specific HPV negative samples taken at two consecutive intervals of approximately 6 months following a positive sample .
RESULTS	The primary endpoint was CIN grade 2 or greater ( CIN2 + ) associated with the same HPV type as a 6MPI .
RESULTS	Secondary endpoints were CIN1 + / CIN3 + associated with the same HPV type as a 6MPI ; CIN1 + / CIN2 + / CIN3 + associated with an infection of any duration ; and clearance of infection .
RESULTS	The analyses included 4825 women with 16,785 infections ( 3363 women with 6902 6MPIs ) .
RESULTS	Risk of developing a CIN1 + / CIN2 + / CIN3 + associated with same HPV type as a 6MPI varied with HPV type and was significantly higher for oncogenic versus non-oncogenic types .
RESULTS	Hazard ratios for development of CIN2 + were 10.44 ( 95 % CI : 6.96-15 .65 ) , 9.65 ( 5.97-15 .60 ) , 5.68 ( 3.50-9 .21 ) , 5.38 ( 2.87-10 .06 ) and 3.87 ( 2.38-6 .30 ) for HPV-16 , HPV-33 , HPV-31 , HPV-45 and HPV-18 , respectively .
RESULTS	HPV-16 or HPV-33 6MPIs had ~ 25-fold higher risk for progression to CIN3 + .
RESULTS	Previous or concomitant HPV infection or CIN1 + associated with a different HPV type increased risk .
RESULTS	Of the different oncogenic HPV types , HPV-16 and HPV-31 infections were least likely to clear .
CONCLUSIONS	Cervical infections with oncogenic HPV types increased the risk of CIN2 + and CIN3 + .
CONCLUSIONS	Previous or concomitant infection or CIN1 + also increased the risk .
CONCLUSIONS	HPV-16 and HPV-33 have by far the highest risk of progression to CIN3 + , and HPV-16 and HPV-31 have the lowest chance of clearance .

###25594434
BACKGROUND	Studies of closed-loop control ( CLC ) systems have improved glucose levels in patients with type 1 diabetes .
BACKGROUND	In this study we test a new CLC concept aiming to `` reset '' the patient overnight to near-normoglycemia each morning , for several consecutive nights .
METHODS	Ten insulin pump users with type 1 diabetes ( mean age , 46.48.5 years ) were enrolled in a two-center ( in the United States and Italy ) randomized crossover trial comparing 5 consecutive nights of CLC ( 23:00 -07:00 h ) in an outpatient setting versus sensor-augmented insulin pump therapy of the same duration at home .
METHODS	Primary end points included time spent in 80-140mg / dL as measured by continuous glucose monitoring overnight and fasting blood glucose distribution at 7:00 h.
RESULTS	Compared with sensor-augmented pump therapy , CLC improved significantly time spent between 80 and 140mg/dL ( 54.5 % vs. 32.2 % ; P < 0.001 ) and between 70 and 180mg/dL ( 85.4 % vs. 59.1 % ; P < 0.001 ) ; CLC reduced the mean glucose level at 07:00 h ( 119.3 vs. 152.9 mg/dL ; P < 0.001 ) and overnight mean glucose level ( 139.0 vs. 170.3 mg/dL ; P < 0.001 ) using a marginally lower amount of insulin ( 6.1 vs. 6.8 units ; P = 0.1 ) .
RESULTS	Tighter overnight control led to improved daytime control on the next day : the overnight/next-day control correlation was r = 0.52 , P < 0.01 .
CONCLUSIONS	Multinight CLC of insulin delivery ( artificial pancreas ) results in significant improvement in morning and overnight glucose levels and time in target range , with the potential to improve daytime control when glucose levels were `` reset '' to near-normoglycemia each morning .

###24639003
OBJECTIVE	To describe a new framework for interleaving scans and demonstrate its usefulness for image-based respiratory motion correction in whole heart coronary MR angiography ( CMRA ) .
METHODS	Scan interleaving using the proposed approach was achieved by switching between separately defined , independent scans at arbitrary time points during their execution , using a generic function call .
METHODS	The scan interleaving framework was used to perform scan interleaving for image-based respiratory navigation of CMRA with spiral , radial , and Cartesian echo-planar imaging ( EPI ) navigator k-space trajectories .
METHODS	Eight healthy volunteers were scanned .
RESULTS	Improved coronary vessel sharpness and visual scores were obtained using spiral and Cartesian EPI navigators compared with radial navigators .
CONCLUSIONS	The usefulness of the proposed scan interleaving framework was demonstrated for image-based respiratory motion correction .
CONCLUSIONS	It facilitated more direct comparisons of image navigator acquisitions with different k-space trajectories .
CONCLUSIONS	Furthermore , we could demonstrate that spiral and Cartesian EPI navigators may be particularly suitable for image-based motion correction , as they provide improved motion correction and high navigator apparent signal-to-noise ratio while spending very little magnetization , thereby minimizing saturation effects .

###25378931
BACKGROUND	The redox imbalance between nitric oxide and superoxide generated in the endothelium is thought to play a pivotal role in the development of endothelial dysfunction .
BACKGROUND	A third reactive oxygen species ( ROS ) , H2O2 , is known to have both beneficial and detrimental effects on the vasculature .
BACKGROUND	Nonetheless , the influence of the hydroxyl radical , a byproduct of H2O2 decay , is unclear , and there is no direct evidence that the hydroxyl radical impairs endothelial function in conduit arteries .
BACKGROUND	Molecular hydrogen ( H2 ) neutralizes detrimental ROS , especially the hydroxyl radical .
OBJECTIVE	To assess the influence of the hydroxyl radical on the endothelium and to confirm that a gaseous antioxidant , H2 , can be a useful modulator of blood vessel function .
METHODS	The efficacy of water containing a high concentration of H2 was tested by measuring flow-mediated dilation ( FMD ) of the brachial artery ( BA ) .
METHODS	The subjects were randomly divided into two groups : the high-H2 group , who drank high-H2 water containing 7 ppm H2 ( 3.5 mg H2 in 500 mL water ) ; and the placebo group .
METHODS	Endothelial function was evaluated by measuring the FMD of the BA .
METHODS	After measurement of diameter of the BA and FMD at baseline , volunteers drank the high-H2 water or placebo water immediately and with a 30-minute interval ; FMD was compared to baseline .
RESULTS	FMD increased in the high-H2 group ( eight males ; eight females ) from 6.80 % 1.96 % to 7.64 % 1.68 % ( mean standard deviation ) and decreased from 8.07 % 2.41 % to 6.87 % 2.94 % in the placebo group ( ten males ; eight females ) .
RESULTS	The ratio to the baseline in the changes of FMD showed significant improvement ( P < 0.05 ) in the high-H2 group compared to the placebo group .
CONCLUSIONS	H2 may protect the vasculature from shear stress-derived detrimental ROS , such as the hydroxyl radical , by maintaining the nitric oxide-mediated vasomotor response .

###24785600
OBJECTIVE	To evaluate whether hysteroscopic morcellation or bipolar electrosurgical resection is more favorable for removing endometrial polyps in an office setting in terms of feasibility , speed , pain , and acceptability .
METHODS	A multicenter , single-blind , randomized , controlled trial of office hysteroscopic morcellation compared with electrosurgical resection was conducted .
METHODS	A total of 121 women were randomly allocated to polyp removal by one of the two methods in an office setting .
METHODS	The outcomes assessed were time taken to complete the endometrial polypectomy , defined as the time from insertion to removal of vaginal instrumentation , completeness of polyp removal , acceptability , and pain measured on a 100-mm visual analog scale .
RESULTS	The median time taken to complete the procedure was 5 minutes and 28 seconds for morcellation compared with 10 minutes and 12 seconds for electrosurgical resection ( P < .001 ) .
RESULTS	The polyps were completely removed in 61 out of 62 ( 98 % ) women assigned to morcellation compared with 49 out of 59 ( 83 % ) women treated with electrosurgical resection ( odds ratio 12.5 ; 95 % confidence interval [ CI ] 1.5-100 .6 ; P = .02 ) .
RESULTS	The mean pain scores during the procedure favored morcellation by 16.1 points on average ( 35.9 compared with 52.0 ; 95 % CI for difference , -24.7 to -7.6 ; P < .001 ) .
RESULTS	Overall , 99 % of women found office polypectomy to be acceptable , with only one woman in the electrosurgical resection group considering the procedure unacceptable .
CONCLUSIONS	In comparison to electrosurgical resection during hysteroscopic polypectomy , morcellation was significantly quicker , less painful , more acceptable to women , and more likely to completely remove endometrial polyps compared with electrosurgical resection .
BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT01509313 .

###24673793
BACKGROUND	Plant and marine n-3 fatty acids ( FA ) may favorably modify select markers of cardiovascular disease risk .
BACKGROUND	Whether supplementing the habitual diet of lacto-ovo-vegetarians ( LOV ) with walnuts ( containing - linolenic acid , ALA ) and n-3 FA enriched eggs ( containing primarily docosahexaenoic acid , DHA and ALA ) would have equivalent effects on CVD risk factors is explored in this study .
METHODS	In this study , 20 healthy free-living LOVs following their habitual diet were randomly assigned in a crossover design to receive one of three supplements : n-3 FA enriched egg ( 6/week ) , walnuts ( 28.4 g , 6/week ) or a standard egg , 6/week ( control ) for 8 weeks each with 4-wk washout between treatments .
METHODS	Erythrocyte membrane fatty acids , serum lipids and inflammatory markers were measured at the end of each treatment .
RESULTS	Dietary compliance was observed by an expected increase in erythrocyte membrane ALA following the walnut treatment and in DHA following the n-3 FA enriched egg treatment .
RESULTS	Walnut treatment lowered serum triacylglycerol , total cholesterol and Apo B ( p < 0.05 ) compared to the standard egg but not the n-3 FA enriched egg treatment .
RESULTS	However , walnut treatment significantly reduced total : HDL cholesterol ratio compared to both egg treatments .
RESULTS	There were no differences between treatments for any of the inflammatory markers .
CONCLUSIONS	For LOV , a direct source of DHA such as n-3 FA enriched eggs seems necessary to increase membrane levels of DHA .
CONCLUSIONS	However for producing an overall favorable blood lipid profile , daily consumption of a handful of walnuts rich in ALA may be a preferred option for lacto-ovo vegetarian .

###24717957
BACKGROUND	Electrolyzed acid water ( EAW ) has been recognized to have strong bactericidal activity , and the feasibility and safety of EAW irrigation in body cavities has been reported in the literature .
BACKGROUND	This study was conducted to evaluate the effect of EAW nasal irrigation on the postoperative care of functional endoscopic sinus surgery ( FESS ) .
METHODS	Patients with chronic rhinosinusitis who received FESS for treatment were recruited and randomly assigned to three groups at 1 month postoperatively .
METHODS	Patients in group 1 received EAW for nasal irrigation daily for 2 months , those in group 2 received neutral normal saline ( NS ) daily for 2 months , and those in group 3 did not receive nasal irrigation after surgery .
METHODS	Before and 3 months after FESS , sinonasal symptoms were assessed by questionnaire and patients received endoscopic examination , acoustic rhinometry , smell test , saccharine transit test , and bacterial culture from middle meatus .
RESULTS	There were 185 patients enrolled between May 2009 and March 2012 .
RESULTS	Among the patients who completed the study , 36 received EWA irrigation , 35 received NS irrigation , and 39 ( group 3 ) received no irrigation .
RESULTS	Patients with nasal irrigation had a better outcome based on questionnaire score and saccharine transit time .
RESULTS	However , there was no difference in outcome between patients who received irrigation with EAW and NS .
CONCLUSIONS	Our study showed that EWA irrigation did not confer a greater benefit than that of NS irrigation in post-FESS care .

###25595232
BACKGROUND	The ICEpop CAPability measure for Older people ( ICECAP-O ) and the Adult Social Care Outcomes Toolkit ( ASCOT ) are preference-based measures for assessing quality of life ( QOL ) from a broader perspective than do traditional health-related QOL measures such as the EuroQol five-dimensional questionnaire ( EQ-5D ) .
BACKGROUND	Measurement properties of these instruments have not yet been directly compared .
OBJECTIVE	The purpose of this study was to compare the test-retest reliability , construct validity , and responsiveness of the three-level EQ-5D ( EQ-5D-3L ) , ICECAP-O , and ASCOT in frail older adults living at home .
METHODS	Cross-sectional data and longitudinal data were used .
METHODS	Parameters for reliability ( the intraclass correlation coefficient ) and agreement ( standard error of measurement ) were used to assess test-retest reliability after 1 week .
METHODS	We formulated hypotheses about correlations with other measures and tested these to assess construct validity and responsiveness ( longitudinal validity ) .
RESULTS	The reliability parameters for all three scales were considered good ( intraclass correlation coefficient values above 0.70 ) .
RESULTS	Standard error of measurement values were less than 10 % of the scale .
RESULTS	Hypotheses regarding construct validity were in general accepted ; the EQ-5D-3L was more strongly associated with physical limitations than were ICECAP-O and ASCOT and less strongly with instruments measuring aspects beyond health .
RESULTS	Longitudinally , as hypothesized , mental health was most strongly associated with ICECAP-O , and self-perceived QOL , mastery , and client-centeredness of home care most strongly with ASCOT .
CONCLUSIONS	Our findings support the adoption of ICECAP-O and ASCOT as outcome measures in economic evaluations of care interventions for older adults that have a broader aim than health-related QOL because they are at least as reliable as the EQ-5D-3L and are associated with aspects of QOL broader than health .

###24479668
OBJECTIVE	To compare the ocular wave-front of eyes with silicone Intraocular lens ( IOLs ) with aspheric and spherical optics after cataract surgery , taking into account the patient 's pupil size under reading conditions and after pupil dilatation .
METHODS	In this institutional prospective , randomized , controlled , patient and examiner masked , bilateral trial with intra-individual comparison , 60 eyes of 30 patients with bilateral age-related cataract were included .
METHODS	Each patient received a spherical IOL ( CeeOn Edge , 911A , AMO , Santa Ana , CA , USA ) in one eye and an aspheric IOL ( Tecnis , Z9000 , AMO ) in the contra-lateral eye .
METHODS	Exclusion criteria were other ocular pathologies , capsular changes or zonular weakness .
METHODS	The main outcome variable was spherical aberration of the ocular wave-front under mesopic pupil conditions measured 2 years after surgery .
METHODS	Additional outcome variables were visual acuity and photopic and mesopic contrast sensitivity .
RESULTS	There was no significant difference in visual acuity between the two IOL types under physiological pupil conditions and also not after pupil dilation .
RESULTS	However , spherical aberrations were significantly lower with the aspheric IOL ( SA : spherical 0.38 m , SD : 0.11 m ; aspheric 0.10 m , SD : 0.13 m ; p < 0.01 ) , and there was a significant difference in contrast sensitivity at 12 cycles/degree .
CONCLUSIONS	This is the first randomized and masked trial on visual function and ocular wave-front after implantation with this silicone aspheric IOL , taking the patients ' own pupil size into account .
CONCLUSIONS	The effect on visual function was detectable for mesopic contrast sensitivity , but there was no difference in visual acuity .
CONCLUSIONS	The SA was found to be significantly lower under physiological pupil conditions as well as when recalculated for the rhexis size and under pharmacological dilatation .

###24682910
BACKGROUND	Hyperglycemia is a common , but not well-characterized side effect of glucocorticoid treatment .
OBJECTIVE	To study the effect of pulse dexamethasone treatment on carbohydrate metabolism among multiple myeloma patients .
METHODS	A randomized crossover observational study in a teaching hospital with nine myeloma patients ( one male , two with known type 2 diabetes ( KDM ) , mean age 69.0 6.7 years ) were investigated using a standard 75 g Oral Glucose Tolerance Test ( patients without KDM ) and a 3-day continuous glucose monitoring ( CGM -- all patients ) during and between dexamethasone cycles .
RESULTS	During dexamethasone treatment patients had elevated 2-h postload glucose ( 12.8 4.7 vs. 8.7 3.2 mmol/L , P = 0.024 ) but similar fasting glucose ( 6.3 1.4 vs. 5.1 0.5 mmol/L , P = 0.112 ) .
RESULTS	Estimated hourly mean interstitial glucose values based on linear mixed models showed an increase of 0.03 [ SE 0.01 ] mmol/L per hour from 5.0 [ 0.4 ] in patients without KDM and followed a quadratic curve from 5.0 [ 0.4 ] mmol/L at midnight to 7.5 [ 0.5 ] mmol/L at 12:00 h in patients with KDM during control periods .
RESULTS	During dexamethasone treatment glucose was similar to control periods between 02:00 and 12:00 h in the non-KDM group , where they followed a cubic trajectory from 5.3 [ 0.4 ] mmol/L at 04:00 h to 7.3 [ 0.4 ] mmol/L at 18:00 h.
RESULTS	In contrast , interstitial glucose was increased by at least 7.9 [ 0.3 ] mmol/L throughout the day in KDM patients during dexamethasone treatment and increased from 13.6 [ 0.5 ] mmol/L at midnight to 17.5 [ 0.5 ] mmol/L at 17:00 h.
CONCLUSIONS	During pulse steroid therapy of myeloma patients without KDM afternoon and evening glucose measurements may be the optimal tools to characterize glucose metabolism .

###24315294
OBJECTIVE	To determine whether topical corticosteroids as adjunctive therapy for bacterial keratitis improves long-term clinical outcomes .
METHODS	Randomized , placebo-controlled , double-masked clinical trial .
METHODS	This multicenter trial compared 1.0 % prednisolone sodium phosphate to placebo in the treatment of bacterial keratitis among 500 patients with culture-positive ulcers receiving 48 hours of moxifloxacin before randomization .
METHODS	The primary endpoint was 3 months from enrollment , and 399 patients were evaluated at 12 months .
METHODS	The outcomes examined were best spectacle-corrected visual acuity ( BSCVA ) and scar size at 12 months .
METHODS	Based on previous results , regression models with adjustments for baseline status and/or causative organism were used for analysis .
RESULTS	No significant differences in clinical outcomes by treatment group were seen with the prespecified regression models ( BSCVA : -0.04 logMAR , 95 % CI , -0.12 to 0.05 , P = .39 ; scar size : 0.03 mm , 95 % CI , -0.12 to 0.18 , P = .69 ) .
RESULTS	A regression model including a Nocardia-treatment arm interaction found corticosteroid use associated with a mean 1-line improvement in BSCVA at 12 months among patients with non-Nocardia ulcers ( -0.10 logMAR , 95 % CI , -0.19 to -0.02 , P = .02 ) .
RESULTS	No significant difference was observed in 12-month BSCVA for Nocardia ulcers ( 0.18 logMAR , 95 % CI , -0.04 to 0.41 , P = .16 ) .
RESULTS	Corticosteroids were associated with larger mean scar size at 12 months among Nocardia ulcers ( 0.47 mm , 95 % CI , 0.06-0 .88 , P = .02 ) and no significant difference was identified by treatment for scar size for non-Nocardia ulcers ( -0.06 mm , 95 % CI , -0.21 to 0.10 , P = .46 ) .
CONCLUSIONS	Adjunctive topical corticosteroid therapy may be associated with improved long-term clinical outcomes in bacterial corneal ulcers not caused by Nocardia species .

###25872651
BACKGROUND	What participants think about the nature of a study might affect their behaviour and bias findings .
BACKGROUND	We tested two hypotheses : ( 1 ) participants told they were in an intervention trial would report lower alcohol consumption at follow-up than those told they were in a cohort study ; ( 2 ) participants told they were in the intervention group in a trial would have lower alcohol consumption at follow-up than those told they were in the control group .
METHODS	Students from four universities ( N = 72,903 ) were invited to participate in a ` research project on student drinking ' .
METHODS	Of 10,415 respondents , 6,788 were moderate to heavy drinkers and were randomized .
METHODS	Group A ( ` cohort ' ) were informed their drinking would be assessed at baseline and again in one month .
METHODS	Group B ( ` control ' ) were told the study was an intervention trial and they were in the control group .
METHODS	Group C ( ` intervention ' ) were told the study was an intervention trial and they were to receive the intervention .
METHODS	All were assessed and directed to read identical online alcohol education material .
METHODS	Whether and how long they accessed the material were recorded .
METHODS	One month later , alcohol intake was reassessed .
RESULTS	In relation to hypothesis 1 , there were no differences between the groups on the prespecified outcome measures .
RESULTS	In relation to hypothesis 2 , there were no differences though all point estimates were in the hypothesized direction ( that is , ` intervention ' < ` control ' ) .
RESULTS	The ` cohort ' and ` control ' groups accessed the material to a similar extent ( 59 % versus 57 % ) while the ` intervention ' group were more likely to access it ( 78 % ) and to read it for longer ( median 35 s ( 25th and 75th percentiles : 6 , 97 ) versus medians of 7 s ( 0 , 28 ) and 8 s ( 4 , 42 ) for the ` cohort ' and ` control ' groups , respectively ) .
CONCLUSIONS	Although the context given to the research participants significantly influenced access to the online information and reading time , this did not translate into any effect on drinking behaviour , for either hypothesis .
CONCLUSIONS	This might be because of failure in the experimental paradigm or the possibility of weaker effects using the online approach .
BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12610000846022 .

###25646876
OBJECTIVE	Advances in technology present opportunities to develop and test innovative teaching methods .
OBJECTIVE	We sought to evaluate whether text messaging could improve medical resident knowledge in musculoskeletal medicine .
METHODS	Eleven U.S. family medicine residency programs with a total of 269 residents participated in this randomized , controlled trial .
METHODS	Residents were invited to complete a pretest to assess musculoskeletal medicine knowledge .
METHODS	The residents randomized to the intervention group were then offered to receive text messages termed electronically Generated Educational Messages ( eGEMs ) three times per week during a 12-week period .
METHODS	The primary outcome was change in pretest and posttest scores among residents in an intervention group ( those who received text messages ) as compared to a control group ( those who did not receive the text messages ) .
METHODS	Focus groups were conducted to assess resident acceptability and usefulness of text messaging as a teaching tool .
RESULTS	Sixty-three residents completed the pretests and posttests .
RESULTS	The intervention group 's score improved from 55 % of questions answered correctly to 64 % ; the control group improved from 56 % to 61 % .
RESULTS	While these pretest/posttest changes each were statistically significant , the difference in improvement between the two groups was not .
RESULTS	Focus groups revealed that participants liked the intervention , but suggestions for improvement included ability to tailor the eGEMs .
CONCLUSIONS	The use of eGEMs as initially developed did not increase resident knowledge based on exam scores .
CONCLUSIONS	Further study is needed to determine if a more tailored intervention is effective .

###24429126
BACKGROUND	We evaluated the effect of dual , longacting inhaled bronchodilator treatment on exacerbations in patients with severe and very severe chronic obstructive pulmonary disease ( COPD ) .
METHODS	In this parallel-group study , 2224 patients ( aged 40 years , Global Initiative for Chronic Obstructive Lung Disease stages III-IV , and one or more moderate COPD exacerbation in the past year ) were randomly assigned ( 1:1:1 ; via interactive voice response or web system ; stratified for smoking status ) to once-daily QVA149 ( fixed-dose combination of indacaterol 110 g and glycopyrronium 50 g ) , glycopyrronium 50 g , or tiotropium 18 g for 64 weeks .
METHODS	Assignment to QVA149 and glycopyrronium was double-blind ; tiotropium was open-label .
METHODS	Efficacy was assessed in all patients randomly assigned to treatment groups who received at least one dose of study drug ; safety was assessed in all patients who received at least one dose whether or not they were assigned to a group .
METHODS	The primary objective was to show superiority of QVA149 versus glycopyrronium for rate of moderate to severe COPD exacerbations ( defined by worsening symptoms and categorised by treatment requirements ) during treatment .
METHODS	This completed trial is registered at ClinicalTrials.gov , NCT01120691 .
RESULTS	Between April 27 , 2010 , and July 11 , 2012 , 741 patients were randomly assigned to receive QVA149 , 741 to receive glycopyrronium , and 742 to receive tiotropium ( 729 , 739 , and 737 patients , respectively , analysed for efficacy ) .
RESULTS	QVA149 significantly reduced the rate of moderate to severe exacerbations versus glycopyrronium by 12 % ( annualised rate of exacerbations 084 [ 95 % CI 075-094 ] vs 095 [ 085-106 ] ; rate ratio 088 , 95 % CI 077-099 , p = 0038 ) .
RESULTS	Adverse events ( including exacerbations ) were reported for 678 ( 93 % ) of 729 patients on QVA149 , 694 ( 94 % ) of 740 on glycopyrronium , and 686 ( 93 % ) of 737 on tiotropium .
RESULTS	Incidence of serious adverse events was similar between groups ( 167 [ 23 % ] patients on QVA149 , 179 [ 24 % ] on glycopyrronium , and 165 [ 22 % ] on tiotropium ) ; COPD worsening was the most frequent serious adverse event ( 107 [ 15 % ] patients on QVA149 , 116 [ 16 % ] on glycopyrronium , 87 [ 12 % ] on tiotropium ) .
CONCLUSIONS	The dual bronchodilator QVA149 was superior in preventing moderate to severe COPD exacerbations compared with the single longacting antimuscarinic bronchodilator glycopyrronium , with concomitant improvements in lung function and health status .
CONCLUSIONS	These results indicate the potential of dual bronchodilation as a treatment option for patients with severe and very severe COPD .
BACKGROUND	Novartis Pharma AG .

###26141467
BACKGROUND	Emerging data suggest instillation of tissue plasminogen activator ( tPA ) is safe and potentially efficacious in the treatment of intra-abdominal abscess .
BACKGROUND	To date , prospective comparative data are lacking in children .
BACKGROUND	Therefore , we conducted a randomized trial comparing abscess irrigation with tPA and irrigation with saline alone .
METHODS	After IRB approval , children with an abscess secondary to perforated appendicitis who had a percutaneous drain placed for treatment were randomized to twice-daily instillation of 13 mL 10 % tPA or 13 mL normal saline .
METHODS	All patients were treated with once-daily dosing of ceftriaxone and metronidazole throughout their course .
METHODS	The primary end point variable was duration of hospitalization after drain placement .
METHODS	Using a power of 0.8 and an of 0.05 , a sample size of 62 patients was calculated .
RESULTS	Sixty-two patients were enrolled between January 2009 and February 2013 .
RESULTS	There were no differences in demographics , abscess size , abscess number , admission WBC , or duration of symptoms .
RESULTS	Duration of hospitalization after drainage was considerably longer with the use of tPA .
RESULTS	There was no difference in total duration of hospitalization , days of drainage , or days of antibiotics .
RESULTS	However , medication charges were higher with tPA .
CONCLUSIONS	There are no advantages to routine tPA flushes in the treatment of abdominal abscess secondary to perforated appendicitis in children .

###24604308
OBJECTIVE	Inflammation may contribute to the pathogenesis of diabetic retinopathy ( DR ) .
OBJECTIVE	To investigate , in a proof-of-concept clinical trial , whether low-dose oral doxycycline monohydrate can ( 1 ) slow the deterioration of , or improve , retinal function or ( 2 ) induce regression or slow the progression of DR in patients with severe nonproliferative DR ( NPDR ) or non-high-risk proliferative ( PDR ) , and to determine the potential usefulness of visual function end points to expedite the feasibility of conducting proof-of-concept clinical trials in patients with DR.
METHODS	We conducted a randomized , double-masked , 24-month proof-of-concept clinical trial .
METHODS	Thirty patients ( from hospital-based retina practices ) with 1 or more eyes with severe NPDR or PDR less than Early Treatment Diabetic Retinopathy Study-defined high-risk PDR .
METHODS	Patients were randomized to receive 50 mg of doxycycline monohydrate or placebo daily for 24 months .
METHODS	Change at 24 months compared with baseline in functional factors ( frequency doubling perimetry [ FDP ] , Humphrey photopic Swedish Interactive Thresholding Algorithm 24-2 testing , contrast sensitivity , dark adaptation , visual acuity , and quality of life ) and anatomic factors ( Early Treatment Diabetic Retinopathy Study DR severity level , area of retinal thickening , central macular thickness , macular volume , and retinal vessel diameters ) .
RESULTS	From baseline to month 24 , mean FDP foveal sensitivity decreased in the placebo group ( -1.9 dB ) and increased in the doxycycline group ( +1.8 dB ) ( P = .02 ) .
RESULTS	A higher mean FDP foveal sensitivity in the doxycycline group compared with the placebo group was detected at 6 months ( P = .04 ) , and this significant difference persisted at 12 and 24 months .
RESULTS	A difference between the groups was not detected with respect to the other visual function outcomes and all anatomic outcomes assessed .
CONCLUSIONS	To our knowledge , this is the first observation suggesting a link between a low-dose oral anti-inflammatory agent and subclinical improvement in inner retinal function .
CONCLUSIONS	Oral doxycycline may be a promising therapeutic strategy targeting the inflammatory component of DR. Furthermore , study results suggest that FDP , which primarily measures inner retinal function , is responsive to intervention and may be a useful clinical trial end point for proof-of-concept studies in patients with DR.
BACKGROUND	clinicaltrials.gov Identifier : NCT00511875 .

###24763930
OBJECTIVE	In Rivaroxaban Once Daily Oral Direct Factor Xa Inhibitor Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation ( ROCKET AF ) trial , rivaroxaban was noninferior to dose-adjusted warfarin in preventing stroke or systemic embolism among patients with nonvalvular atrial fibrillation at moderate to high stroke risk .
OBJECTIVE	Because of differences in patient demographics , epidemiology , and stroke risk management in East Asia , outcomes and relative effects of rivaroxaban versus warfarin were assessed to determine consistency among East Asians versus other ROCKET AF participants .
METHODS	Baseline demographics and interaction of treatment effects of rivaroxaban and warfarin among patients within East Asia and outside were assessed .
RESULTS	A total of 932 ( 6.5 % ) ROCKET AF participants resided in East Asia .
RESULTS	At baseline , East Asians had lower weight , creatinine clearance , and prior vitamin K antagonist use ; higher prevalence of prior stroke ; and less congestive heart failure and prior myocardial infarction than other participants .
RESULTS	Despite higher absolute event rates for efficacy and safety outcomes in East Asians , the relative efficacy of rivaroxaban ( 20 mg once daily ; 15 mg once daily for creatinine clearance of 30-49 mL/min ) versus warfarin with respect to the primary efficacy end point ( stroke/systemic embolism ) was consistent among East Asians and non-East Asians ( interaction P = 0.666 ) .
RESULTS	Relative event rates for the major or nonmajor clinically relevant bleeding in patients treated with rivaroxaban and warfarin were consistent among East Asians and non-East Asians ( interaction P = 0.867 ) .
CONCLUSIONS	Observed relative efficacy and safety of rivaroxaban versus warfarin were similar among patients within and outside East Asia .
CONCLUSIONS	Rivaroxaban , 20 mg once daily , is an alternative to warfarin for stroke prevention in East Asians with nonvalvular atrial fibrillation .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00123456 .

###24341348
BACKGROUND	Formal rehabilitation programs are often assumed to be required after total knee arthroplasty to optimize patient recovery .
BACKGROUND	Inpatient rehabilitation is a costly rehabilitation option after total knee arthroplasty and , in Australia , is utilized most frequently for privately insured patients .
BACKGROUND	With the exception of comparisons with domiciliary services , no randomized trial has compared inpatient rehabilitation to any outpatient based program .
BACKGROUND	The Hospital Inpatient versus HOme ( HIHO ) study primarily aims to determine whether 10 days of post-acute inpatient rehabilitation followed by a hybrid home program provides superior recovery of functional mobility on the 6-minute walk test ( 6MWT ) compared to a hybrid home program alone following total knee arthroplasty .
BACKGROUND	Secondarily , the trial aims to determine whether inpatient rehabilitation yields superior recovery in patient-reported function .
METHODS	This is a two-arm parallel randomized controlled trial ( RCT ) , with a third , non-randomized , observational group .
METHODS	One hundred and forty eligible , consenting participants who have undergone a primary total knee arthroplasty at a high-volume joint replacement center will be randomly allocated when cleared for discharge from acute care to either 10 days of inpatient rehabilitation followed by usual care ( a 6-week hybrid home program ) or to usual care .
METHODS	Seventy participants in each group ( 140 in total ) will provide 80 % power at a significance level of 5 % to detect an increase in walking capacity from 400 m to 460 m between the Home and Inpatient groups , respectively , in the 6MWT at 6 months post-surgery , assuming a SD of 120 m and a drop-out rate of < 10 % .
METHODS	The outcome assessor will assess participants at 10 , 26 and 52 weeks post-operatively , and will remain blind to group allocation for the duration of the study , as will the statistician .
METHODS	Participant preference for rehabilitation mode stated prior to randomization will be accounted for in the analysis together with any baseline differences in potentially confounding characteristics as required .
CONCLUSIONS	The HIHO Trial will be the first RCT to investigate the efficacy of inpatient rehabilitation compared to any outpatient alternative following total knee arthroplasty .
BACKGROUND	U.S. National Institutes of Health Clinical Trials Registry ( http://clinicaltrials.gov ) ref : NCT01583153 .

###25913081
BACKGROUND	The aim of the study was to compare the efficacy of the TruView EVO2 , TruView PCD , and Miller laryngoscopes for tracheal intubation during cardiopulmonary resuscitation with and without chest compressions ( CCs ) by paramedics in an infant manikin model .
METHODS	This was an open , prospective , randomized , simulated trial .
METHODS	After a brief didactic session , 78 volunteer paramedics attempted to intubate a manikin using TruView EVO2 , TruView PCD , and Miller laryngoscopes during resuscitation with and without CC scenarios .
METHODS	Primary end point was intubation success rate and secondary was time to intubation with each device .
METHODS	Glottic view using a Cormack-Lehane grade in using each device was also assessed .
RESULTS	In scenario with uninterrupted CCs , the median time to intubation using the TruView EVO2 , TruView PCD , and Miller varied with the times being 25.3 seconds ( interquartile range [ IQR ] , 23-30 .5 seconds ) vs 20.2 seconds ( IQR , 18-23 seconds ) vs 24.4 seconds ( IQR , 21-28 seconds ) , respectively .
RESULTS	The overall success rate of intubation during CC for the devices were 94.9 % vs 100 % vs 92.1 % .
RESULTS	During intubation without CC , median time to intubation varied and amounted to 24.9 seconds ( IQR , 21-29 .6 seconds ) for TruView EVO2 , 18.3 seconds ( IQR , 16-21 .3 seconds ) for TruView PCD , and 19.4 seconds ( IQR , 17-23 .3 seconds ) for Miller laryngoscope .
RESULTS	The overall success rate of intubation without CC for all devices was 100 % .
CONCLUSIONS	For infant tracheal intubation with TruView PCD , when used by paramedics , the malleable TruView PCD showed shorter intubation time and higher overall success rate in a simulated CC scenario than TruView EVO2 or Miller laryngoscopes .
CONCLUSIONS	Further clinical studies are necessary to confirm these initial positive findings .

###24331680
OBJECTIVE	This study evaluates the efficacy of the Choose Health program , a family-based cognitive behavioural lifestyle program targeting improved eating and activity habits , in improving body composition , cardiovascular fitness , eating and activity behaviours in overweight and obese adolescents .
METHODS	The sample comprised 29 male and 34 female overweight ( n = 15 ) or obese ( n = 48 ) adolescents aged 11.5-18 .9 years ( M = 14.3 , SD = 1.9 ) .
METHODS	Participants were randomly allocated to treatment or waitlist control conditions ; waitlist condition participants were offered treatment after 6 months .
METHODS	DEXA-derived and anthropometric measures of body composition ; laboratory-based cycle ergometer and field-assessed cardiovascular fitness data ; objective and self-report physical activity measures ; and self-report measures of eating habits and 7-day weighed food diaries were used to assess treatment outcome .
METHODS	Adherence to treatment protocols was high .
RESULTS	Treatment resulted in significant ( p < .05 ) and sustained improvements in a range of body composition ( body fat , percent body fat , lean mass ) and anthropometric measures ( weight , BMI , BMI-for-age z-score and percentiles ) .
RESULTS	Minimal improvements were seen in cardiovascular fitness .
RESULTS	Similar results were obtained in completer and intention-to-treat analysis .
RESULTS	Poor adherence to assessment protocols limits conclusions that can be drawn from physical activity and dietary data .
CONCLUSIONS	Participation in the Choose Health program resulted in significant improvement in body composition .
CONCLUSIONS	Longer-term follow up is required to determine the durability of intervention effects .
CONCLUSIONS	Alternative approaches to the measurement of diet and physical activity may be required for adolescents .

###24918558
OBJECTIVE	Compare the safety and efficacy of 1 % and 5 % silica encapsulated benzoyl peroxide ( E-BPO ) in patients with papulopustular rosacea .
METHODS	Multi-centered randomized , double blind , vehicle controlled parallel group , 12 week treatment in 92 patients with papulopustular rosacea .
METHODS	Primary endpoints were dichotomized IGA with success defined as clear/near clear and reduction in inflammatory lesions .
METHODS	92 patients : 74 % graded as moderate IGA , 14 % severe and 12 % mild .
METHODS	The mean inflammatory lesion count was 24 .
METHODS	Once daily treatment for 12 weeks with vehicle , 1 % or 5 % E-BPO .
RESULTS	1 % and 5 % E-BPO were superior to vehicle in reducing papulopustular lesions P = 0.01 and P = 0.02.5 % E-BPO was superior to vehicle for IGA P = 0.0013 .

###25388481
OBJECTIVE	Patients discharged from the emergency department ( ED ) are often referred for primary care , specialty , or other disease-specific follow-up appointments .
OBJECTIVE	Attendance at these scheduled follow-up appointments has been found to improve patient outcomes , decrease ED bounce-backs , and reduce malpractice risk .
OBJECTIVE	Reasons for missing follow-up visits are complex , but the most commonly reason cited by patients is simply forgetting .
OBJECTIVE	In this study the authors evaluated the ability of an automated text message reminder system to increase attendance at post-ED discharge follow-up appointments in a predominantly Hispanic safety-net population .
METHODS	This was a randomized controlled trial of ED patients with outpatient follow-up visits scheduled at the time of ED discharge .
METHODS	A total of 374 English - and Spanish-speaking patients with text-capable mobile phones were enrolled .
METHODS	Patients in the intervention arm received automated , personalized text message appointment reminders including date , time , and clinic location at 7 , 3 , and 1 day before scheduled visits .
METHODS	A t-test of proportions was used to compare outcomes between intervention and control groups .
METHODS	Both an intention-to-treat ( ITT ) and a per-protocol analysis of the data were performed .
METHODS	The ITT more accurately reflects real-world conditions where errors such as number entry errors are bound to occur .
METHODS	The per-protocol analysis adds value by isolating the effect of the intervention by comparing patients who actually received it compared with those who did not .
RESULTS	In the per-protocol analysis of the primary outcome , the overall appointment adherence rate was 72.6 % in the intervention group compared with 62.1 % in the control group ( difference between groups = 10.5 % , 95 % confidence interval [ CI ] = 0.3 % to 20.8 % ; p = 0.045 ; number needed to treat = 9.5 ) .
RESULTS	In the ITT analysis , the overall appointment attendance rate 70.2 % in the intervention group compared with 62.1 % in the control group ( difference between groups = 8.2 % ; 95 % CI = -1.6 % to 17.7 % ; p = 0.100 ) .
RESULTS	In a secondary largely exploratory analysis , the intervention was found to have the most benefit in patients with the lowest baseline follow-up rate ( English speakers with specialty care appointments ) .
CONCLUSIONS	Automated text message appointment reminders resulted in improvement in attendance at scheduled post-ED discharge outpatient follow-up visits and represent a low-cost and highly scalable solution to increase attendance at post-ED follow-up appointments , which should be further explored in larger sample sizes and diverse patient populations .

###24597683
BACKGROUND	Stress , depression , and anxiety affect 15 to 25 % of pregnant women .
BACKGROUND	However , fewer than 20 % of prenatal care providers assess and treat mental health problems and fewer than 20 % of pregnant women seek mental healthcare .
BACKGROUND	For those who seek treatment , the lack of health system integration and existing barriers frequently prevent treatment access .
BACKGROUND	Without treatment , poor prenatal mental health can persist for years and impact future maternal , child , and family well-being .
METHODS	The purpose of this randomized controlled trial is to evaluate the effectiveness of an integrated process of online psychosocial assessment , referral , and cognitive behavior therapy ( CBT ) for pregnant women compared to usual prenatal care ( no formal screening or specialized care ) .
METHODS	The primary outcome is self-reported prenatal depression , anxiety , and stress symptoms at 6 to 8 weeks postrandomization .
METHODS	Secondary outcomes are postpartum depression , anxiety , and stress symptoms ; self-efficacy ; mastery ; self-esteem ; sleep ; relationship quality ; coping ; resilience ; Apgar score ; gestational age ; birth weight ; maternal-infant attachment ; infant behavior and development ; parenting stress/competence ; and intervention cost-effectiveness , efficiency , feasibility , and acceptability .
METHODS	Pregnant women are eligible if they : 1 ) are < 28 weeks gestation ; 2 ) speak/read English ; 3 ) are willing to complete email questionnaires ; 4 ) have no , low , or moderate psychosocial risk on screening at recruitment ; and 5 ) are eligible for CBT .
METHODS	A sample of 816 women will be recruited from large , urban primary care clinics and allocation is by computer-generated randomization .
METHODS	Women in the intervention group will complete an online psychosocial assessment , and those with mild or moderate depression , anxiety , or stress symptoms then complete six interactive cognitive behavior therapy modules .
METHODS	All women will complete email questionnaires at 6 to 8 weeks postrandomization and at 3 , 6 , and 12 months postpartum .
METHODS	Clinic-based providers and researchers conducting chart abstraction and analysis are blinded .
METHODS	Qualitative interviews with 8 to 10 healthcare providers and 15 to 30 intervention group women will provide data on feasibility and acceptability of the intervention .
METHODS	Results of this trial will determine the feasibility and effectiveness of an integrated approach to prenatal mental healthcare and the use of highly accessible computer-based psychosocial assessment and CBT on maternal , infant , and family-based outcomes .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01901796 .

###24708773
BACKGROUND	Low levels of physical activity , musculoskeletal morbidity and weight gain are commonly reported problems in children with cancer .
BACKGROUND	Intensive medical treatment and a decline in physical activity may also result in reduced motor performance .
BACKGROUND	Therefore , simple and inexpensive ways to promote physical activity and exercise are becoming an increasingly important part of children 's cancer treatment .
METHODS	The aim of this study is to evaluate the effect of active video games in promotion of physical activity in children with cancer .
METHODS	The research is conducted as a parallel randomized clinical trial with follow-up .
METHODS	Patients between 3 and 16 years old , diagnosed with cancer and treated with vincristine in two specialized medical centers are asked to participate .
METHODS	Based on statistical estimates , the target enrollment is 40 patients .
METHODS	The intervention includes playing elective active video games and , in addition , education and consultations for the family .
METHODS	The control group will receive a general recommendation for physical activity for 30 minutes per day .
METHODS	The main outcomes are the amount of physical activity and sedentary behavior .
METHODS	Other outcomes include motor performance , fatigue and metabolic risk factors .
METHODS	The outcomes are examined with questionnaires , diaries , physical examinations and blood tests at baseline and at 2 , 6 , 12 and 30 months after the baseline .
METHODS	Additionally , the children 's perceptions of the most enjoyable activation methods are explored through an interview at 2 months .
CONCLUSIONS	This trial will help to answer the question of whether playing active video games is beneficial for children with cancer .
CONCLUSIONS	It will also provide further reasoning for physical activity promotion and training of motor skills during treatment .
BACKGROUND	ClinicalTrials.gov identifier : NCT01748058 ( October 15 , 2012 ) .

###24726342
BACKGROUND	In COPD patients , reversibility is currently evaluated from the changes of forced expiratory volume at 1s ( FEV1 ) and forced vital capacity ( FVC ) .
BACKGROUND	By lowering peripheral airway smooth muscle tone , bronchodilators should decrease dynamic hyperinflation , gas trapping , and possibly dyspnea at rest .
BACKGROUND	Hence , we hypothesize that specific airway resistance changes ( sRAW ) should better characterize the acute response to bronchodilators .
METHODS	On two days , 60 COPD patients underwent dyspnea evaluation ( VAS score ) and pulmonary function testing at baseline and one hour after placebo or 300g indacaterol administration .
RESULTS	Spirographic and sRAW-based criteria identified as responders 24 and 45 patients , respectively .
RESULTS	sRAW correlated with changes of intrathoracic gas volume ( ITGV ) ( r = 0.61 ; p < 0.001 ) , residual volume ( RV ) ( r = 0.60 ; p < 0.001 ) , FVC ( r = 0.44 ; p = 0.001 ) , and VAS ( r = 0.73 ; p < 0.001 ) , while FEV1 correlated only with FVC ( r = 0.34 ; p = 0.008 ) .
RESULTS	Significant differences in terms of ITGV ( p = 0.002 ) , RV ( p = 0.023 ) , and VAS ( p < 0.001 ) occurred only if patients were stratified according to sRAW .
CONCLUSIONS	In assessing the acute functional effect of bronchodilators , sRAW-based criterion is preferable to FEV1-FVC-based criteria , being more closely related to bronchodilator-induced improvements of lung mechanics and dyspnea at rest .

###24696094
OBJECTIVE	In schizophrenia , the severity of negative symptoms is a key predictor of long-term disability .
OBJECTIVE	Deficient signaling through the N-methyl-D-aspartate receptor is hypothesized to underlie many signs and symptoms associated with schizophrenia in particular negative symptoms .
OBJECTIVE	Glycine acts as an N-methyl-D-aspartate receptor coagonist .
OBJECTIVE	Blockade of the glycine transporter type 1 to inhibit glycine reuptake and elevate synaptic glycine concentrations represents an effective strategy to enhance N-methyl-D-aspartate receptor transmission .
OBJECTIVE	To determine the efficacy and safety of bitopertin ( RG1678 ) , a glycine reuptake inhibitor , in patients with schizophrenia and predominant negative symptoms who were stable while taking an antipsychotic treatment .
METHODS	This randomized , double-blind , placebo-controlled , phase 2 proof-of-concept trial involved 323 patients with schizophrenia and predominant negative symptoms across 66 sites worldwide .
METHODS	Bitopertin ( 10 , 30 , or 60 mg/d ) or placebo added to standard antipsychotic therapy for a treatment duration of 8 weeks .
METHODS	Change from baseline in the Positive and Negative Syndrome Scale negative factor score .
RESULTS	In the per-protocol population , 8 weeks of treatment with bitopertin was associated with a significant reduction of negative symptoms in the 10-mg/d ( mean [ SE ] reduction in negative symptoms score , -25 % [ 2 % ] ; P = .049 ) and 30-mg/d ( mean [ SE ] , -25 % [ 2 % ] ; P = .03 ) bitopertin groups , a significantly higher response rate and a trend toward improved functioning in the 10-mg/d group when compared with placebo ( mean [ SE ] , -19 % [ 2 % ] ) .
RESULTS	Results reached trend-level significance in the intent-to-treat population .
RESULTS	Estimates of bitopertin binding to glycine transporter type 1 showed that low to medium levels of occupancy yielded optimal efficacy in patients , consistent with findings in preclinical assays .
CONCLUSIONS	Bitopertin-mediated glycine reuptake inhibition may represent a novel treatment option for schizophrenia , with the potential to address negative symptoms .
BACKGROUND	clinicaltrials.gov Identifier : NCT00616798 .

###24886552
BACKGROUND	Polyphenols may lower the risk of cardiovascular disease ( CVD ) and other chronic diseases due to their antioxidant and anti-inflammatory properties , as well as their beneficial effects on blood pressure , lipids and insulin resistance .
BACKGROUND	However , no previous epidemiological studies have evaluated the relationship between the intake of total polyphenols intake and polyphenol subclasses with overall mortality .
BACKGROUND	Our aim was to evaluate whether polyphenol intake is associated with all-cause mortality in subjects at high cardiovascular risk .
METHODS	We used data from the PREDIMED study , a 7,447-participant , parallel-group , randomized , multicenter , controlled five-year feeding trial aimed at assessing the effects of the Mediterranean Diet in primary prevention of cardiovascular disease .
METHODS	Polyphenol intake was calculated by matching food consumption data from repeated food frequency questionnaires ( FFQ ) with the Phenol-Explorer database on the polyphenol content of each reported food .
METHODS	Hazard ratios ( HR ) and 95 % confidence intervals ( CI ) between polyphenol intake and mortality were estimated using time-dependent Cox proportional hazard models .
RESULTS	Over an average of 4.8 years of follow-up , we observed 327 deaths .
RESULTS	After multivariate adjustment , we found a 37 % relative reduction in all-cause mortality comparing the highest versus the lowest quintiles of total polyphenol intake ( hazard ratio ( HR ) = 0.63 ; 95 % CI 0.41 to 0.97 ; P for trend = 0.12 ) .
RESULTS	Among the polyphenol subclasses , stilbenes and lignans were significantly associated with reduced all-cause mortality ( HR = 0.48 ; 95 % CI 0.25 to 0.91 ; P for trend = 0.04 and HR = 0.60 ; 95 % CI 0.37 to 0.97 ; P for trend = 0.03 , respectively ) , with no significant associations apparent in the rest ( flavonoids or phenolic acids ) .
CONCLUSIONS	Among high-risk subjects , those who reported a high polyphenol intake , especially of stilbenes and lignans , showed a reduced risk of overall mortality compared to those with lower intakes .
CONCLUSIONS	These results may be useful to determine optimal polyphenol intake or specific food sources of polyphenols that may reduce the risk of all-cause mortality .
BACKGROUND	ISRCTN35739639 .

###24387157
BACKGROUND	Cardiovascular morbidity and mortality is high in patients with chronic obstructive pulmonary disease ( COPD ) and arterial stiffness is a potentially modifiable risk factor with added predictive value beyond that obtained from traditional risk factors .
BACKGROUND	Arterial stiffness has been the target of pharmacologic and exercise interventions in patients with COPD , but the effects appear limited to those patients with more significant elevations in arterial stiffness .
BACKGROUND	We aimed to identify predictors of increased arterial stiffness in a cohort with moderate to severe COPD .
METHODS	Aortic pulse wave velocity ( aPWV ) was measured in subjects with moderate to severe COPD enrolled in a multicenter randomized controlled trial .
METHODS	Subjects were categorized into quartiles based on aPWV values and factors affecting high arterial stiffness were assessed .
METHODS	Multivariate models were created to identify independent predictors of high aPWV , and cardiovascular disease ( CVD ) .
RESULTS	153 patients were included .
RESULTS	Mean age was 63.2 ( SD 8.2 ) years and mean FEV1 was 55.4 ( SD 15.2 ) % predicted .
RESULTS	Compared to the quartile with the lowest aPWV , subjects in the highest quartile were older , had higher systolic blood pressure ( SBP ) , were more likely to be current smokers , and had greater burden of thoracic aortic calcification .
RESULTS	On multivariate analyses , age ( adjusted OR 1.14 , 95 % CI 1.05 to 1.25 , p = 0.003 ) and SBP ( adjusted OR 1.06 , 95 % CI 1.02 to 1.09 , p = 0.001 ) were independent predictors of elevated aPWV .
RESULTS	Body mass index , therapy with cholesterol lowering medications and coronary calcification were independent predictors of CVD .
CONCLUSIONS	Elevated arterial stiffness in patients with COPD can be predicted using age , blood pressure and thoracic aortic calcification .
CONCLUSIONS	This will help identify subjects for enrollment in clinical trials using aPWV for assessing the impact of COPD therapies on CV outcomes .

###24825262
OBJECTIVE	To evaluate the non-inferiority of a lower therapeutic dose ( 300,000 IU ) in comparison to standard dose ( 600,000 ) IU of Vitamin D for increasing serum 25 ( OH ) D levels and achieving radiological recovery in nutritional rickets .
METHODS	Randomized , open-labeled , controlled trial .
METHODS	Tertiary care hospital .
METHODS	76 children ( median age 12 mo ) with clinical and radiologically confirmed rickets .
METHODS	Oral vitamin D3 as 300,000 IU ( Group 1 ; n = 38 ) or 600,000 IU ( Group 2 ; n = 38 ) in a single day .
METHODS	Primary : Serum 25 ( OH ) D , 12 weeks after administration of vitamin D3 ; Secondary : Radiological healing and serum parathormone at 12 weeks ; and clinical and biochemical adverse effects .
RESULTS	Serum 25 ( OH ) D levels [ geometric mean ( 95 % CI ) ] increased significantly from baseline to 12 weeks after therapy in both the groups [ Group 1 : 7.58 ( 5.5010.44 ) to 16.06 ( 12.71 20.29 ) ng/mL , P < 0.001 ] ; Group 2 : 6.57 ( 4.669.25 ) to 17.60 ( 13.7122.60 , P < 0.001 ] .
RESULTS	The adjusted ratio of geometric mean serum 25 ( OH ) D levels at 12 weeks between the groups ( taking baseline value as co-variate ) was 0.91 ( 95 % CI : 0.651.29 ) .
RESULTS	Radiological healing occurred in all children by 12 weeks .
RESULTS	Both groups demonstrated significant ( P < 0.05 ) and comparable fall in the serum parathormone and alkaline phosphatase levels at 12 weeks .
RESULTS	Relative change [ ratio of geometric mean ( 95 % CI ) ] in serum PTH and alkaline phosphatase , 12 weeks after therapy , were 0.98 ( 0.71.47 ) and 0.92 ( 0.721.19 ) , respectively .
RESULTS	The serum 25 ( OH ) D levels were deficient ( < 20 ng/mL ) in 63 % ( 38/60 ) children after 12 weeks of intervention [ Group 1 : 20/32 ( 62.5 % ) ; Group 2 : 18/28 ( 64.3 % ) ] .
RESULTS	No major clinical adverse effects were noticed in any of the children .
RESULTS	Hypercalcemia was documented in 2 children at 4 weeks ( 1 in each Group ) and 3 children at 12 weeks ( 1 in Group 1 and 2 in Group 2 ) .
RESULTS	None of the participants had hypercalciuria or hypervitaminosis D.
CONCLUSIONS	A dose of 300,000 IU of vitamin D3 is comparable to 600,000 IU , administered orally , over a single day , for treating rickets in under-five children although there is an unacceptably high risk of hypercalcemia in both groups .
CONCLUSIONS	None of the regime is effective in normalization of vitamin D status in majority of patients , 3 months after administering the therapeutic dose .

###24357810
OBJECTIVE	The aim of this study was to identify serum markers that are modulated by an investigational anti-IFN - mAb , sifalimumab , in adult DM or PM patients .
METHODS	In a phase 1b clinical trial , sera were collected from a total of 48 DM or PM adult patients receiving either placebo for 3 months or sifalimumab for 6 months .
METHODS	Samples were tested for 128 selected proteins using a multiplex luminex immunoassay .
METHODS	Muscle biopsies from selected patients were stained for T cell infiltration using an anti-CD3 antibody .
RESULTS	A robust overexpression of multiple serum proteins in DM or PM patients was observed , particularly in patients with an elevated baseline type I IFN gene signature in the blood or muscle .
RESULTS	Neutralization of the type I IFN gene signature by sifalimumab resulted in coordinated suppression of T cell-related proteins such as soluble IL-2RA , TNF receptor 2 ( TNFR2 ) and IL-18 .
RESULTS	Muscle biopsies from two patients with the highest serum protein suppression were selected and found to have a pronounced reduction of muscle T cell infiltration .
RESULTS	Down-regulation of IL-2RA correlated with favourable manual muscle test 8 ( MMT-8 ) alterations in sifalimumab-dosed patients .
CONCLUSIONS	A reduced level of multiple T cell-associated proteins after sifalimumab but not placebo administration suggests a suppressive effect of blocking type I IFN signalling on T cell activation and chemoattraction that may lead to a reduction of T cell infiltration in the muscle of myositis patients .
CONCLUSIONS	Further , soluble IL-2RA changes from baseline may serve as a responsive and/or predictive marker for type I IFN-targeted therapy in adult DM or PM patients .

###24839887
OBJECTIVE	The present study aims to assess the efficacy of a structured psychoeducational group intervention for adolescents with early-onset psychosis and their families .
OBJECTIVE	The intervention was implemented in parallel in 2 separate groups by focusing specifically on problem-solving strategies and structured psychosis-related information to manage daily life difficulties associated with the disease , to mitigate crises , and to prevent relapses .
METHODS	We performed a 9-month , randomized , rater-blinded clinical trial involving 55 adolescent patients with early-onset psychosis and either or both of their parents .
METHODS	A psychoeducational problem-solving group intervention ( n = 27 ) was compared with a nonstructured group intervention ( n = 28 ) .
METHODS	The primary outcomes were number of hospitalizations , days of hospitalization , and visits to the emergency department .
METHODS	The secondary outcome measures were clinical variables and family environment .
RESULTS	Assessments were performed before and after the intervention .
RESULTS	At the end of the group intervention , 15 % of patients in the psychoeducational group and 39 % patients in the nonstructured group had visited the emergency department ( = 3.62 , df = 1 , p = .039 ) .
RESULTS	The improvement in negative symptoms was more pronounced in the psychoeducational group ( 12.84 [ 7.87 ] ) than in the nonstructured group ( 15.81 [ 6.37 ] ) ( p = .039 ) .
CONCLUSIONS	A parallel psychoeducational group intervention providing written instructions in a structured manner could help adolescents with early-onset psychosis and their parents to manage crises by implementing problem-solving strategies within the family , thus reducing the number of visits to the emergency department .
CONCLUSIONS	Negative symptoms improved in adolescents in the psychoeducational group .

###24569032
OBJECTIVE	The AVERROES double-blinded , randomized trial demonstrated that apixaban reduces the risk of stroke or systemic embolism ( SSE ) by 55 % compared with aspirin without an increase in major bleeding in patients with atrial fibrillation either who previously tried but failed vitamin K antagonists ( VKA ) therapy or who were expected to be unsuitable for VKA therapy .
OBJECTIVE	In this pre-specified analysis , we explored the consistency of the results in the subgroup of patients who tried but failed VKA therapy .
RESULTS	Of 5599 patients , 2216 ( 40 % ) had previously failed VKA treatment [ main reasons : poor international normalized ratio ( INR ) control 42 % , refusal 37 % , bleeding on VKA 8 % ] .
RESULTS	Compared with those expected to be unsuitable for VKA therapy , those who had previously failed were older , more often male , had higher body mass index , more likely to have moderate renal impairment and a history of stroke and less likely to have heart failure or to be medically undertreated .
RESULTS	The effects of apixaban compared with aspirin were consistent in those who previously failed and those who were expected to be unsuitable , for both SSE ( P interaction 0.13 ) and major bleeding ( P interaction 0.74 ) and were also consistent among different subgroups of patients who had previously failed VKA therapy defined by reasons for unsuitability , age , sex , renal function , CHADS2 score , aspirin dose , duration , indication , and quality of INR control of prior VKA use .
CONCLUSIONS	The efficacy and safety of apixaban compared with aspirin is consistent in subgroups of patients who have previously attempted but failed VKA therapy , irrespective of the reason for discontinuation .

###24893766
BACKGROUND	Evidence suggests that intestinal microbiota play an important role in the pathogenesis of atopic dermatitis ( AD ) through induction of immunosuppression and immune tolerance ; however , the exact underlying mechanism is unclear .
BACKGROUND	Few studies to date have examined the effects of probiotics on adult-type AD .
OBJECTIVE	To examine the effects of the probiotic Bifidobacterium animalis subsp lactis LKM512 on adult-type AD and the expression of metabolites that are known to be influenced by gut microbiota in fecal samples .
METHODS	Forty-four patients were randomly assigned to receive LKM512 or a placebo and underwent medical examinations .
METHODS	Fecal microbiota were analyzed with real-time polymerase chain reaction .
METHODS	Metabolomic analysis was conducted to search for antipruritic metabolites produced by intestinal bacteria using feces derived from 3 patients whose itch scores had improved using capillary electrophoresis with time-of-flight mass spectrometry .
METHODS	Antipruritic effects of kynurenic acid were observed using AD-induced NC/Nga mice .
RESULTS	LKM512 administration alleviated itch in AD patients compared with controls and improved the dermatology-specific quality-of-life scores when compared with the controls .
RESULTS	Administration of LKM512 also increased the expression of the antipruritic and antinociceptive metabolite kynurenic acid ( KYNA ) in patients whose itch score had improved after LKM512 treatment .
RESULTS	In mouse experiments , scratching behavior counts tended to be decreased by KYNA injection when compared with no treatment .
CONCLUSIONS	LKM512 administration may exert antipruritic effects by increasing KYNA production .
CONCLUSIONS	LKM512 could therefore be a potentially effective therapeutic candidate for the reduction of pruritus .
BACKGROUND	umin.ac.jp / ctr Identifier : UMIN000005695 .

###25549482
BACKGROUND	It is common knowledge that an increase of intra-abdomninal pressure ( lAP ) causes a decrease in the volume of cerebrospinal fluid in the lumbar and lower thoracic region , which may contribute to the development of more high spinal block .
BACKGROUND	There is currently no research devoted to studying the impact of intra-abdominal pressure in pregnancy on the development of high spinal blockade .
OBJECTIVE	To investigate effects of intra-abdominal pressure in pregnancy on the development of spinal blockade and incidence of hypotension during cesarean section .
METHODS	170 pregnant women with gestational age 38-40 weeks were included in the randomized , blinded , controlled study .
METHODS	All the women received elective cesarean section under spinal anesthesia ( SA ) .
METHODS	Pregnant women w | , ere divided into two groups of 85 females each .
METHODS	In the first group , the anesthesiologist did not know the value of lAP and used the dose of local anesthetic focusing on height , weight , and according to his own experience .
METHODS	In the second group , an anesthesiologist corrected dose of local anesthetic depending on the lAP and also considered the height and weight of a woman .
RESULTS	In 9.2 % of women , lAP was less than 11 mmHg ( physiologically normal ) , in 49 % -- from 12 to 15 mmHg ( degree I of intra-abdominal hypertension ( IAH ) ) , in 40.3 % -- from 16 to 20 mmHg ( degree II of IAH ) , in 1.5 % -- from 21 to 25 mmHg ( degree III of IAH ) .
RESULTS	In the first group , the incidence of high spinal block ( above Th4 ) and incidence of arterial hypotension ( systolic blood pressure under 90 mm.Hg ) was two times higher than in the second group ( p < 0.01 ) .
CONCLUSIONS	Intra-abdominal hypertension in pregnant women contributed to the development of high spinal block and hypotension .
CONCLUSIONS	To prevent these complications , we recommend decreasing the dose of local anesthetic with use of the Scale of the Risk of developing high spinal block in pregnant .

###25620449
OBJECTIVE	We examine whether the Shifting Boundaries ( SB ) intervention , a primary intervention to prevent youth dating violence and sexual harassment ( DV/H ) , is differentially effective for girls compared with boys or for youth with a history of DV/H experiences .
METHODS	We randomly assigned SB to 30 public middle schools in New York City , enrolling 117 sixth and seventh grade classes to receive a classroom , building , combined , or neither intervention .
METHODS	The SB classroom intervention included six sessions emphasizing the laws/consequences of DV/H , establishing boundaries and safe relationships .
METHODS	The SB schoolwide/building intervention included the use of school-based restraining orders , greater faculty/security presence in unsafe `` hot spots '' mapped by students , and posters to increase DV/H awareness and reporting .
METHODS	Student surveys were implemented at baseline , immediately after intervention , and 6 months after intervention .
RESULTS	At 6 months after intervention , the SB building-level intervention was associated with significant reductions in the frequency of sexual harassment ( SH ) perpetration and victimization ; the prevalence and frequency of sexual dating violence victimization ; and the frequency of total dating violence victimization and perpetration .
RESULTS	We also had one anomalous finding that the interventions were associated with an increase in the prevalence of SH victimization .
RESULTS	These results were consistent for girls and boys , and those with or without a history of DV/H , with the one exception for those exposed to the SB building condition who had earlier reported perpetrating SH had a significantly lower frequency of perpetrating SH at the follow-up than those without such a history .
CONCLUSIONS	SB can provide effective universal prevention of middle school DV/H experiences , regardless of students ' prior exposure histories , and for boys and girls .

###24680549
BACKGROUND	Edoxaban is an oral , direct , once-daily factor Xa inhibitor .
BACKGROUND	This study evaluated the safety and efficacy of edoxaban compared to subcutaneous enoxaparin in Japanese patients undergoing hip fracture surgery .
METHODS	In this multicenter , randomized , open-label , active-comparator , phase 3 trial , 92 patients were randomized 2:1 to receive edoxaban 30mg once daily ( n = 62 ) or enoxaparin sodium ( enoxaparin ) 2000IU ( equivalent to 20mg ) twice daily ( n = 30 ) for 11 to 14days .
METHODS	The primary endpoints were the incidence of major or clinically relevant non-major ( CRNM ) bleeding and incidence of any bleeding events ( major , CRNM , or minor bleeding ) .
METHODS	Secondary efficacy endpoints included the incidence of thromboembolic events , venous thromboembolism-related deaths , and all-cause deaths .
METHODS	Additional adverse events were recorded throughout the study .
RESULTS	In the edoxaban and enoxaparin treatment groups , the incidence of major or CRNM bleeding was 3.4 % and 6.9 % , respectively , while any bleeding event occurred in 25.4 % and 17.2 % of patients , respectively .
RESULTS	The incidence of thromboembolic events was 6.5 % in the edoxaban group and 3.7 % in the enoxaparin group .
RESULTS	All events were asymptomatic deep vein thrombosis .
RESULTS	The incidence of adverse events was 72.9 % and 82.8 % in the edoxaban and enoxaparin groups , respectively .
CONCLUSIONS	Compared to subcutaneous enoxaparin 2000IU twice daily , oral edoxaban 30mg once daily demonstrated similar safety and efficacy in the prevention of thromboembolic events in Japanese patients undergoing hip fracture surgery .
BACKGROUND	NCT01181141 .

###24222666
BACKGROUND	The prevalence and significance of low normal and abnormal ankle brachial index ( ABI ) values in a community-dwelling population of sedentary , older individuals is unknown .
BACKGROUND	We describe the prevalence of categories of definite peripheral artery disease ( PAD ) , borderline ABI , low normal ABI , and no PAD and their association with lower-extremity functional performance in the LIFE Study population .
RESULTS	Participants age 70 to 89 in the LIFE Study underwent baseline measurement of the ABI , 400-m walk , and 4-m walking velocity .
RESULTS	Participants were classified as follows : definite PAD ( ABI < 0.90 ) , borderline PAD ( ABI 0.90 to 0.99 ) , low normal ABI ( ABI 1.00 to 1.09 ) , and no PAD ( ABI 1.10 to 1.40 ) .
RESULTS	Of 1566 participants , 220 ( 14 % ) had definite PAD , 250 ( 16 % ) had borderline PAD , 509 ( 33 % ) had low normal ABI , and 587 ( 37 % ) had no PAD .
RESULTS	Among those with definite PAD , 65 % were asymptomatic .
RESULTS	Adjusting for age , sex , race , body mass index , smoking , and comorbidities , lower ABI was associated with longer mean 400-m walk time : ( definite PAD = 533 seconds ; borderline PAD = 514 seconds ; low normal ABI = 503 seconds ; and no PAD = 498 seconds [ P < 0.001 ] ) .
RESULTS	Among asymptomatic participants with and without PAD , lower ABI values were also associated with longer 400-m walk time ( P < 0.001 ) and slower walking velocity ( P = 0.042 ) .
CONCLUSIONS	Among older community-dwelling men and women , 14 % had PAD and 49 % had borderline or low normal ABI values .
CONCLUSIONS	Lower ABI values were associated with greater functional impairment , suggesting that lower extremity atherosclerosis may be a common preventable cause of functional limitations in older people .
BACKGROUND	http://clinicaltrials.gov/ Unique identifier : NCT01072500 .

###24984823
OBJECTIVE	Magnesium plays an important role in the modulation of vascular tone and endothelial function and can regulate glucose and lipid metabolism .
OBJECTIVE	Patients with hypertension , metabolic syndrome ( MetS ) and diabetes mellitus ( T2DM ) have low body magnesium content ; indeed , magnesium supplementation has been shown to have a positive effect on blood pressure ( BP ) and gluco-metabolic parameters .
OBJECTIVE	The aim of our study was to evaluate the effect of magnesium supplements on hemodynamic and metabolic parameters in healthy men with a positive family history of MetS or T2DM .
RESULTS	In a randomized , double-blind , placebo-controlled 8-week crossover trial with a 4 week wash-out period , oral supplements of 8.1 mmol of magnesium-pidolate or placebo were administered twice a day to 14 healthy normomagnesemic participants , aged 23-33 years .
RESULTS	The primary endpoint was office BP , measured with a semiautomatic oscillometric device .
RESULTS	Secondary endpoints included characteristics of the MetS , namely endothelial function , arterial stiffness and inflammation .
RESULTS	Plasma and urinary magnesium were measured in all participants while free intracellular magnesium was measured only in a subsample .
RESULTS	There was no significant difference in either systolic and diastolic BP in participants post-magnesium supplementation and post-placebo treatment when compared to baseline BP measurements .
RESULTS	Further , the metabolic , inflammatory and hemodynamic parameters did not vary significantly during the study .
CONCLUSIONS	Our study showed no beneficial effect of magnesium supplements on BP , vascular function and glycolipid profile in young men with a family history of MetS/T2DM ( trial registration at clinicaltrial.gov ID : NCT01181830 ; 12th of Aug 2010 ) .

###24969712
OBJECTIVE	To explore the safety and efficacy of high-frequency chest wall oscillation ( HFCWO ) in invasive mechanical ventilation patients with acute exacerbation of chronic obstructive pulmonary disease ( AECOPD ) .
METHODS	A prospective , randomized , controlled trial was conducted .
METHODS	Thirty-five AECOPD patients with invasive mechanical ventilation were included in the intensive care unit of West China Hospital of Sichuan University from February 2012 to February 2013 .
METHODS	The patients were randomly allocated into a HFCWO ( H ) group and a control group using SAS 9.1 software .
METHODS	The control group received routine therapy , while the H group received HFCWO , along with routine therapy .
METHODS	Invasive mechanical ventilation time , noninvasive ventilation time , total mechanical ventilation time , ICU stay time , hospital stay time and pH , oxygen index ( OI ) during the first 7 days were collected .
METHODS	At the same time , heart rate , blood pressure , respiratory rate , SpO2 and peak airway pressure before , during and after HFCWO and ventilation alarm of the H group were collected .
RESULTS	The total mechanical ventilation time of patients in the H group was significantly shorter than that of the control group [ ( 10 6 ) d and ( 15 8 ) d , P < 0.05 ] .
RESULTS	But there were no significant differences between the 2 groups in invasive mechanical ventilation time , noninvasive ventilation time , ICU stay and hospital stay time ( P > 0.05 ) .
RESULTS	There were no significant differences between the 2 groups in pH and oxygen index during the first 7 days ( P > 0.05 ) .
RESULTS	There were no change in heart rate , blood pressure , respiratory rate , SpO2 and peak airway pressure before , during and after HFCWO in the H group ( P > 0.05 ) .
RESULTS	Severe ventilator alarm ( level 3 ) occurred in 3.67 % patients , but there was no significant correlation between ventilation alarm and patient prognosis .
CONCLUSIONS	HFCWO is very safe and comfortable in ventilated patients with AECOPD .
CONCLUSIONS	It reduces the total mechanical ventilation time , but can not improve the prognosis .

###25822306
OBJECTIVE	To evaluate , in situ , the penetration of deposits formed within the subsurface of dentin samples treated with desensitizing dentifrices designed to occlude dentin tubules compared to two controls .
METHODS	Twenty-eight healthy participants wore left and right intraoral appliances , each retaining four human dentin samples , for two periods of 4 days .
METHODS	Samples were power-brushed , outside the mouth , twice daily with test products ( dentifrices containing 8 % strontium or 8 % arginine ) or control ( 1,450 ppm NaF or water ) and subjected to an agitated grapefruit juice acid challenge on days 3 and 4 .
METHODS	Eighteen dentin samples were randomly selected from each treatment group and were dry fractured for scanning electron microscopy and energy-dispersive x-ray spectroscopy analysis .
RESULTS	The proportion of cross-sectioned dentin tubules with subsurface occlusion ( occluded to a mean of 5 2 m , range : 1 to 9 m below the surface ) for the 8 % strontium group on days 1 and 2 ( pre-acid ) was 82 % ( SD : 9 % , 95 % confidence interval [ CI ] = 78 % to 86 % ) and on days 3 and 4 ( post-acid ) was 88 % ( SD : 10 % , CI = 83 % to 93 % ) .
RESULTS	For 8 % arginine on days 3 and 4 ( post-acid ) , the proportion was 78 % ( SD : 8 % , CI = 74 % to 82 % ) .
RESULTS	These results were statistically significant compared to those for controls ( P < .01 ) .
RESULTS	The 8 % arginine on days 1 and 2 ( pre-acid ) and water and control paste on all days revealed no subsurface deposit .
CONCLUSIONS	Within the limitations of this study , cross-sectional SEM analysis suggested strontium and arginine dentifrices occlude tubules subsurface in dentin compared to negative controls following acid challenge .
CONCLUSIONS	The desensitizing dentifrices elicit subsurface changes that may potentiate their effects for the management of dentin hypersensitivity , particularly for patients who consume acidic beverages .

###25428583
OBJECTIVE	Increased circulating endostatin levels have been demonstrated in progressive cardiovascular ( CV ) and renal disorders .
OBJECTIVE	We investigated the predictive value of endostatin in patients with chronic heart failure ( HF ) and the association between endostatin and renal function .
METHODS	The interaction between serum endostatin , estimated glomerular filtration rate ( eGFR ) and predefined endpoints , including the primary endpoint ( CV death , nonfatal myocardial infarction , nonfatal stroke ; n = 397 ) , all-cause mortality ( n = 410 ) , CV death ( n = 335 ) or the coronary endpoint ( n = 317 ) , was evaluated in 1,390 patients > 60 years of age with ischemic systolic HF in the Controlled Rosuvastatin Multinational Trial in HF ( CORONA ) population , who were randomly assigned to 10 mg rosuvastatin or placebo .
RESULTS	In the population as a whole , endostatin added no predictive information after full multivariable adjustment including eGFR and N-terminal pro-brain natriuretic peptide .
RESULTS	Serum endostatin was strongly correlated with eGFR ( r = 0.59 , p < 0.001 ) .
RESULTS	After full multivariable adjustment , an association between high serum endostatin and increased risk of all-cause mortality and decreased risk of the primary and coronary endpoints was seen in HF patients with impaired and preserved renal function , respectively .
CONCLUSIONS	Endostatin added no predictive information regarding the adverse outcome in patients with chronic systolic HF of ischemic etiology .
CONCLUSIONS	An increased risk of all-cause mortality was seen in patients with decreased renal function .

###25444374
BACKGROUND	The number of preterm birth is increasing worldwide , especially in low income countries .
BACKGROUND	Malawi has the highest incidence of preterm birth in the world , currently estimated at 18.1 percent .
BACKGROUND	The aim of this study was to explore the perceived causes of preterm birth , care practices for preterm newborn babies and challenges associated with preterm birth among community members in Mangochi District , southern Malawi .
METHODS	We conducted 14 focus group discussions with the following groups of participants : mothers ( n = 4 ) , fathers ( n = 6 ) and grandmothers ( n = 4 ) for 110 participants .
METHODS	We conducted 20 IDIs with mothers to preterm newborns ( n = 10 ) , TBAs ( n = 6 ) and traditional healers ( n = 4 ) .
METHODS	A discussion guide was used to facilitate the focus group and in-depth interview sessions .
METHODS	Data collection took place between October 2012 and January 2013 .
METHODS	We used content analysis to analyze data .
RESULTS	Participants mentioned a number of perceptions of preterm birth and these included young and old maternal age , heredity , sexual impurity and maternal illness during pregnancy .
RESULTS	Provision of warmth was the most commonly reported component of care for preterm newborns .
RESULTS	Participants reported several challenges to caring for preterm newborns such as lack of knowledge on how to provide care , poverty , and the high time burden of care leading to neglect of household , farming and business duties .
RESULTS	Women had the main responsibility for caring for preterm newborns .
CONCLUSIONS	In this community , the reported poor care practices for preterm newborns were associated with poverty and lack of knowledge of how to properly care for these babies at home .
CONCLUSIONS	Action is needed to address the current care practices for preterm babies among the community members .

###24938562
OBJECTIVE	Uveal melanoma is characterized by mutations in GNAQ and GNA11 , resulting in mitogen-activated protein kinase pathway activation .
OBJECTIVE	To assess the efficacy of selumetinib , a selective , non-adenosine triphosphate competitive inhibitor of MEK1 and MEK2 , in uveal melanoma .
METHODS	Randomized , open-label , phase 2 clinical trial comparing selumetinib vs chemotherapy conducted from August 2010 through December 2013 among 120 patients with metastatic uveal melanoma at 15 academic oncology centers in the United States and Canada .
METHODS	One hundred one patients were randomized in a 1:1 ratio to receive selumetinib , 75 mg orally twice daily on a continual basis ( n = 50 ) , or chemotherapy ( temozolomide , 150 mg/m2 orally daily for 5 of every 28 days , or dacarbazine , 1000 mg/m2 intravenously every 21 days [ investigator choice ] ; n = 51 ) until disease progression , death , intolerable adverse effects , or withdrawal of consent .
METHODS	After primary outcome analysis , 19 patients were registered and 18 treated with selumetinib without randomization to complete the planned 120-patient enrollment .
METHODS	Patients in the chemotherapy group could receive selumetinib at the time of radiographic progression .
METHODS	Progression-free survival , the primary end point , was assessed as of April 22 , 2013 .
METHODS	Additional end points , including overall survival , response rate , and safety/toxicity , were assessed as of December 31 , 2013 .
RESULTS	Median progression-free survival among patients randomized to chemotherapy was 7 weeks ( 95 % CI , 4.3-8 .4 weeks ; median treatment duration , 8 weeks ; interquartile range [ IQR ] , 4.3-16 weeks ) and among those randomized to selumetinib was 15.9 weeks ( 95 % CI , 8.4-21 .1 weeks ; median treatment duration , 16.1 weeks ; IQR , 8.1-25 .3 weeks ) ( hazard ratio , 0.46 ; 95 % CI , 0.30-0 .71 ; P < .001 ) .
RESULTS	Median overall survival time was 9.1 months ( 95 % CI , 6.1-11 .1 months ) with chemotherapy and 11.8 months ( 95 % CI , 9.8-15 .7 months ) with selumetinib ( hazard ratio , 0.66 ; 95 % CI , 0.41-1 .06 ; P = .09 ) .
RESULTS	No objective responses were observed with chemotherapy .
RESULTS	Forty-nine percent of patients treated with selumetinib achieved tumor regression , with 14 % achieving an objective radiographic response to therapy .
RESULTS	Treatment-related adverse events were observed in 97 % of patients treated with selumetinib , with 37 % requiring at least 1 dose reduction .
CONCLUSIONS	In this hypothesis-generating study of patients with advanced uveal melanoma , selumetinib compared with chemotherapy resulted in a modestly improved progression-free survival and response rate ; however , no improvement in overall survival was observed .
CONCLUSIONS	Improvement in clinical outcomes was accompanied by a high rate of adverse events .
BACKGROUND	clinicaltrials.gov Identifier : NCT01143402 .

###25011720
BACKGROUND	Patients with severe aortic stenosis ( AS ) who were deemed too high risk or inoperable for conventional aortic valve replacement ( AVR ) in the PARTNER ( Placement of Aortic Transcatheter Valves ) trial were randomized to transcatheter aortic valve replacement ( TAVR ) versus AVR ( PARTNER-A arm ) or standard therapy ( PARTNER-B arm ) .
OBJECTIVE	This study compared when and how deaths occurred after TAVR versus surgical AVR or standard therapy .
METHODS	The PARTNER-A arm included 244 transfemoral ( TF ) and 104 transapical ( TA ) TAVR patients , and 351 AVR patients ; the PARTNER-B arm included 179 TF-TAVR patients and 179 standard therapy patients .
METHODS	Deaths were categorized as cardiovascular , noncardiovascular , or uncategorizable , and were characterized by multiphase hazard modelling .
RESULTS	In the PARTNER-A arm , the risk of death peaked after randomization in the TA-TAVR and AVR groups , falling to low levels commensurate with the U.S. population within 3 months .
RESULTS	Early risk was less in TF-TAVR patients , resulting in initial superior survival ; between 12 and 18 months , risk increased , such that within 2 years , TF-TAVR and AVR patients had similar survival rates .
RESULTS	Cardiovascular , noncardiovascular , and uncategorizable deaths for TF-TAVR were 37 % , 43 % , and 20 % , respectively , versus 22 % , 41 % , and 37 % , respectively , for TA-TAVR and 33 % , 43 % , and 24 % , respectively , for AVR .
RESULTS	In the PARTNER-B arm , risk with standard therapy was 60 % per year ; TF-TAVR reduced risk to 20 % per year , resulting in 0.5 years of life added within 2.5 years .
CONCLUSIONS	In inoperable AS patients , TAVR substantially reduced the risk of cardiovascular death .
CONCLUSIONS	In high-risk patients , TA-TAVR and AVR were associated with elevated peri-procedural risk more than with TF-TAVR , although cardiovascular death was higher after TF-TAVR .
CONCLUSIONS	Therefore , TF-TAVR should be considered the standard of care for severely symptomatic inoperable patients or those at high risk of noncardiovascular mortality after conventional surgery .
CONCLUSIONS	( THE PARTNER TRIAL : Placement of AoRTic TraNscathetER Valve Trial ; NCT00530894 ) .

###24740935
OBJECTIVE	To evaluate if pulsatile cardiopulmonary bypass ( CPB ) has any protective influence on renal function in elderly patients undergoing aortic valve replacement ( AVR ) .
METHODS	Forty-six patients ( 75 years old ) with aortic valve stenosis underwent AVR with either pulsatile perfusion ( PP ) or non-pulsatile perfusion ( NP ) during CPB .
METHODS	Haemodynamic efficacy of the blood pump during either type of perfusion was described in terms of the energy equivalent pressure and the surplus haemodynamic energy .
METHODS	Urine samples were collected before surgery , at sternum closure , and at 2 and 18 h of intensive care unit stay to detect acute kidney injury markers .
METHODS	Perioperative urine levels of N-acetyl -- D-glucosaminidase ( NAG ) , kidney injury molecule-1 and neutrophil gelatinase-associated lipocalin ( NGAL ) were assessed together with plasma creatinine , creatinine clearance ( CCr ) and 24-h haemodynamic monitoring .
METHODS	Normally distributed continuous variables were described as mean standard deviation and non-normally distributed data were presented as the median [ 25th-75th percentiles ] .
RESULTS	PP was characterized by a significantly higher amount of surplus haemodynamic energy transferred to the patients ( P < 0.001 ) , with lower mean systemic vascular resistance during CPB ( P = 0.020 ) and during 18 h postoperatively ( group-P = 0.018 ) .
RESULTS	No difference was found between pre - and postoperative CCr in the PP group ( 71 23 vs 60 35 ml/min , P = 0.27 ) , while its statistically significant perioperative decrement was observed in the NP group ( 67 24 vs 45 15 ml/min , P < 0.001 ) .
RESULTS	The PP group showed significantly lower urinary levels of NAG at 18 h postoperatively ( P = 0.008 ) , and NGAL at sternum closure ( P = 0.010 ) , 2 h ( P < 0.001 ) and 18 h ( P = 0.015 ) postoperatively .
CONCLUSIONS	Short-term PP in elderly patients showed higher safety for renal physiology than NP , resulting in better maintenance of glomerular filtration and lower renal tissue injury .

###25670360
BACKGROUND	Restricted intakes of saturated and trans-fatty acids is emphasized in heart-healthy diets , and replacement with poly - and monounsaturated fatty acids is encouraged .
OBJECTIVE	To compare the effects of polyunsaturated fatty acid-rich corn oil ( CO ) and monounsaturated fatty acid-rich extra-virgin olive oil ( EVOO ) on plasma lipids in men and women ( N = 54 ) with fasting low-density lipoprotein cholesterol ( LDL-C ) 130mg/dL and < 200mg/dL and triglycerides ( TG ) 350mg/dL .
METHODS	In a double-blind , randomized , crossover design ( 21-day treatments , 21-day washout between ) , 4 tablespoons/day CO or EVOO were provided in 3 servings study product/day ( muffin , roll , yogurt ) as part of a weight-maintenance diet ( 35 % fat , < 10 % saturated fat , < 300mg cholesterol ) .
METHODS	Subjects ate breakfast at the clinic every weekday throughout the study .
METHODS	Lunches , dinners , and snacks ( and breakfasts on weekends ) were provided for consumption away from the clinic .
RESULTS	Baseline mean ( standard error ) lipids in mg/dL were : LDL-C 153.3 ( 3.5 ) , total cholesterol ( total-C ) 225.7 ( 3.9 ) , non-high-density lipoprotein ( non-HDL ) - C 178.3 ( 3.7 ) , HDL-C 47.4 ( 1.7 ) , total-C/HDL-C 5.0 ( 0.2 ) , and TG 124.8 ( 7.2 ) .
RESULTS	CO resulted in significantly larger least-squares mean % changes ( all P < .001 vs EVOO ) from baseline in LDL-C -10.9 vs -3.5 , total-C -8.2 vs -1.8 , non-HDL-C -9.3 vs -1.6 , and total-C/HDL-C -4.4 vs 0.5 .
RESULTS	TG rose a smaller amount with CO , 3.5 vs 13.0 % with EVOO ( P = .007 ) .
RESULTS	HDL-C responses were not significantly different between conditions ( -3.4 vs -1.7 % ) .
CONCLUSIONS	Consumption of CO in a weight-maintenance , low saturated fat and cholesterol diet resulted in more favorable changes in LDL-C and other atherogenic lipids vs EVOO .

###24797396
OBJECTIVE	The aim of the current study was to assess whether a multifaceted intervention could improve mental health literacy , facilitate help seeking and reduce psychological distress and alcohol misuse in students of a multicampus university in Melbourne , Australia .
METHODS	In this cluster randomized trial , nine university campuses were paired ( some pairs included more than one campus ) , with one of each pair randomly assigned to either the intervention or control condition .
METHODS	The interventions were designed to be whole-of-campus and to run over 2 academic years with their effectiveness assessed through recruitment of a monitoring sample of students from each campus .
METHODS	Interventions included emails , posters , campus events , factsheets/booklets and mental health first aid training courses .
METHODS	Participants had a 20-min telephone interview at baseline and at the end of academic years 1 and 2 .
METHODS	This assessed mental health literacy , help seeking , psychological distress and alcohol use .
METHODS	The primary outcomes were depression and anxiety levels and alcohol use and pertained to the individual level .
RESULTS	There were no effects on psychological distress and alcohol use .
RESULTS	Recall of intervention elements was greater in the intervention group at the end of year 2 .
RESULTS	Students in the intervention group were more likely to say they would go to a drug and alcohol centre for alcohol problems at the end of 6 months .
CONCLUSIONS	Although education and awareness may play a role in improving mental health literacy , it is likely that , to achieve changes in psychological distress , interventions would need to be more personalized and intensive .

###26444729
BACKGROUND	Daclizumab high-yield process ( HYP ) is a humanized monoclonal antibody that binds to CD25 ( alpha subunit of the interleukin-2 receptor ) and modulates interleukin-2 signaling .
BACKGROUND	Abnormalities in interleukin-2 signaling have been implicated in the pathogenesis of multiple sclerosis and other autoimmune disorders .
METHODS	We conducted a randomized , double-blind , active-controlled , phase 3 study involving 1841 patients with relapsing-remitting multiple sclerosis to compare daclizumab HYP , administered subcutaneously at a dose of 150 mg every 4 weeks , with interferon beta-1a , administered intramuscularly at a dose of 30 g once weekly , for up to 144 weeks .
METHODS	The primary end point was the annualized relapse rate .
RESULTS	The annualized relapse rate was lower with daclizumab HYP than with interferon beta-1a ( 0.22 vs. 0.39 ; 45 % lower rate with daclizumab HYP ; P < 0.001 ) .
RESULTS	The number of new or newly enlarged hyperintense lesions on T2-weighted magnetic resonance imaging ( MRI ) over a period of 96 weeks was lower with daclizumab HYP than with interferon beta-1a ( 4.3 vs. 9.4 ; 54 % lower number of lesions with daclizumab HYP ; P < 0.001 ) .
RESULTS	At week 144 , the estimated incidence of disability progression confirmed at 12 weeks was 16 % with daclizumab HYP and 20 % with interferon beta-1a ( P = 0.16 ) .
RESULTS	Serious adverse events , excluding relapse of multiple sclerosis , were reported in 15 % of the patients in the daclizumab HYP group and in 10 % of those in the interferon beta-1a group .
RESULTS	Infections were more common in the daclizumab HYP group than in the interferon beta-1a group ( in 65 % vs. 57 % of the patients , including serious infection in 4 % vs. 2 % ) , as were cutaneous events such as rash or eczema ( in 37 % vs. 19 % , including serious events in 2 % vs. < 1 % ) and elevations in liver aminotransferase levels that were more than 5 times the upper limit of the normal range ( in 6 % vs. 3 % ) .
CONCLUSIONS	Among patients with relapsing-remitting multiple sclerosis , daclizumab HYP showed efficacy superior to that of interferon beta-1a with regard to the annualized relapse rate and lesions , as assessed by means of MRI , but was not associated with a significantly lower risk of disability progression confirmed at 12 weeks .
CONCLUSIONS	The rates of infection , rash , and abnormalities on liver-function testing were higher with daclizumab HYP than with interferon beta-1a .
CONCLUSIONS	( Funded by Biogen and AbbVie Biotherapeutics ; DECIDE ClinicalTrials.gov number , NCT01064401 . )

###24257457
BACKGROUND	Supraglottic airway devices are often used in airway management to facilitate tracheal intubation .
BACKGROUND	Knowledge of the distance from the grille of the device to the patient 's vocal cords is essential for the safe passage of the tracheal tube below the vocal cords .
OBJECTIVE	To assess the distance from the glottis to the grille of three supraglottic airway devices [ LMA ( LMA Unique ) , Air-Q ( Air-Q Intubating Laryngeal Airway Reusable ) and CobraPLA ( Cobra Perilaryngeal Airway ) ] and their safe usage as intubation conduits .
METHODS	Randomised controlled trial .
METHODS	Tertiary , university hospital .
METHODS	Thirty women undergoing elective gynaecological surgery with planned supraglottic airway management .
METHODS	In-vivo fibreoptic assessment and in-vitro measurement .
METHODS	The distance from the grille to the glottis was defined as primary outcome .
METHODS	The distance from the beginning of the cuff of a tracheal tube passed through the device to the grille was assessed as secondary outcome .
RESULTS	The three devices exhibited significant differences in the meanSD distance from the glottis to the grille ( LMA 4.61.5 cm , Air-Q 5.71.4 cm , CobraPLA 3.41.4 cm ; P = 0.009 ) .
RESULTS	The Air-Q was predicted to allow the safe passage of a tracheal tube into the trachea , whereas the cuff was predicted to rest on the vocal cords in 57 % of the LMA patients and 14 % of the CobraPLA patients .
CONCLUSIONS	Using the LMA Unique as a conduit for tracheal intubation may pose a safety risk , whereas the use of the Air-Q would position the tracheal tube at a safe depth in the trachea .

###25627092
OBJECTIVE	To determine whether short-term intensive group-based therapy combining modified constraint-induced movement therapy and bimanual therapy ( hybrid-CIMT ) is more effective than an equal total dose of distributed individualized occupational therapy ( standard care ) on upper limb motor and individualized outcomes .
METHODS	Fifty-three children with unilateral cerebral palsy ( 69 % males ; mean age 7y 10mo , SD 2y 4mo ; Manual Ability Classification System level I , n = 24 ; level II , n = 23 ) were randomly allocated , and 44 received either hybrid-CIMT ( n = 25 ) or standard care ( n = 19 ) .
METHODS	Standard care comprised six weekly occupational therapy sessions and a 12-week home programme .
METHODS	Outcomes were assessed at baseline , 13weeks , and 26weeks after treatment .
RESULTS	Groups were equivalent at baseline .
RESULTS	Standard care achieved greater gains on satisfaction with occupational performance after intervention ( estimated mean difference -1.2 , 95 % CI -2.2 to -0.1 ; p = 0.04 ) and Assisting Hand Assessment at 26weeks ( estimated mean difference 3.1 , 95 % CI 0.2-6 .0 ; p = 0.04 ) .
RESULTS	Both groups demonstrated significant improvements in dexterity of the impaired upper limb , and bimanual and occupational performance over time .
RESULTS	The differences between groups were not clinically meaningful .
CONCLUSIONS	There were no differences between the two models of therapy delivery .
CONCLUSIONS	Group-based intensive camps may not be readily available ; however , individualized standard care augmented with a home programme may offer an effective alternative but needs to be provided at a sufficient dose .

###24374721
OBJECTIVE	A randomized controlled trial with a matched design was conducted during October 2008 and February 2010 , aiming at reducing HIV-related stigma in healthcare settings .
METHODS	Forty county hospitals in Fujian and Yunnan provinces of China were matched into pairs and randomized to either an intervention condition or a control condition .
METHODS	Forty-four service providers were randomly selected from each hospital , yielding a sample of 1,760 .
METHODS	Intervention outcomes were assessed at baseline , 6 and 12months based on venue-based pair comparisons .
METHODS	We identified and trained 30 popular opinion leaders in each intervention hospital among service providers to disseminate stigma-reduction messages to their peer providers .
RESULTS	Hospital and participant characteristics were comparable between the intervention and control conditions .
RESULTS	Thirteen out of twenty pairs of hospitals showed significant reduction in the stigma outcome measure at the 6-month follow-up assessment .
RESULTS	For most hospitals , the intervention effects were maintained at the 12-month follow-up assessment .
RESULTS	Among the 13 pair of hospitals , which showed intervention effects at 6months , eight were in Fujian and five were in Yunnan .
RESULTS	The non-significant hospitals at 6months had more beds than significant hospitals .
RESULTS	However , the difference did not reach statistical significance .
CONCLUSIONS	A matched design and venue-based analysis provide more insight in assessing intervention effects for facility-based intervention trials .
CONCLUSIONS	The identification of venue-based or hospital characteristics that are associated with intervention efficacy provides additional implications for the adaptation and implementation of future interventions .

###24398722
OBJECTIVE	Transcranial direct current stimulation ( tDCS ) of the motor cortex seems to be effective in improving motor performance in patients with chronic stroke , while some recent findings have reported conflicting results for the subacute phase .
OBJECTIVE	We aimed to verify whether upper extremity motor rehabilitation could be enhanced by treatment with tDCS administered before a rehabilitative session .
METHODS	Hand dexterity and force in 16 individuals with subacute stroke were assessed before ( T0 ) and after anodal stimulation ( T1 ) and after a successive session of motor rehabilitation ( T2 ) in a double-blind , randomized , sham-controlled , crossover trial .
METHODS	To confirm the value of the device as a specific effector , behavioral tests were also administered .
RESULTS	Anodal and sham stimulation plus rehabilitation significantly improved manual dexterity ( repeated-measure Anova : A-tDCS : p = 0.005 ; S-tDCS : p = 0.042 ) .
RESULTS	Post hoc analysis revealed a significant stimulation effect only for A-tDCS ( p = 0.013 between T0 and T1 ) and not for S-tDCS , whereas the rehabilitation effect ( between T1 and T2 ) was not significant in either group .
RESULTS	Hand force and behavioral features were unchanged .
CONCLUSIONS	Anodal brain stimulation improves hand dexterity but does not increase the effectiveness of the rehabilitation directly .
CONCLUSIONS	These results suggest the presence of aftereffects , not priming effects , of A-tDCS superimposed onto motor learning phenomena .

###25064436
OBJECTIVE	The purpose of this study was to evaluate whether use of combined radiofrequency ablation ( RFA ) and percutaneous iodine-125 ( ( 125 ) I ) seed implantation results in better progression-free survival compared with the use of RFA alone in patients with hepatocellular carcinoma .
METHODS	136 patients were randomly assigned to undergo HCC treatment with RFA and percutaneous iodine-125 seed implantation ( RFA - ( 125 ) I , n = 68 ) or RFA-only ( n = 68 ) .
METHODS	A total of 91 patients had hepatitis B viral infection in both groups .
METHODS	Rates of tumour recurrence and overall survival were evaluated .
RESULTS	The probabilities of recurrence at 1 - , 3 - , and 5-years were 4.5 % , 22.1 % , and 39.8 % in the RFA - ( 125 ) I group ; and 14.8 % , 35.3 % , and 57.4 % in the RFA-only group , respectively .
RESULTS	The recurrence rate in the RFA - ( 125 ) I group was significantly lower than in the RFA-only group ( HR , 0.508 ; 95 % CI , 0.317-0 .815 ; p = 0.004 by log-rank test ) .
RESULTS	Local and intrahepatic recurrence was significantly lower in the RFA - ( 125 ) I group than in the RFA-only group ( 7.3 % vs. 22.0 % , p = 0.012 by log-rank test ; 17.6 % vs. 32.3 % , p = 0.041 by log-rank test ) .
RESULTS	The probabilities of survival at 1 - , 3 - , and 5-years were 100 % , 86.7 % , and 66.1 % in the RFA - ( 125 ) I group and 95.6 % , 75.0 % , and 47.0 % in the RFA-only group , respectively .
RESULTS	The survival rate in the RFA - ( 125 ) I group was significantly better than in the RFA-only group ( HR , 0.502 ; 95 % CI , 0.313-0 .806 ; p = 0.003 by log-rank test ) .
RESULTS	Cox regression model indicated that the treatment group and tumour size were both recurrence-related and overall survival-related prognostic factors .
CONCLUSIONS	There were significant differences in overall survival and cumulative recurrence between RFA - ( 125 ) I and RFA-only for patients with small HCCs ( 3 cm ) .
CONCLUSIONS	Treatment with RFA - ( 125 ) I facilitated better local and intrahepatic tumour control and long-term survival compared with treatment of RFA alone .
CONCLUSIONS	ClinicalTrials.gov Identifier : NCT01717729 .

###24786928
OBJECTIVE	To determine the elapsed time while receiving aggressive therapy to the first observation of clinically inactive disease ( CID ) , total duration of CID and potential predictors of this response in a cohort of children with recent onset of polyarticular juvenile idiopathic arthritis ( poly-JIA ) .
METHODS	Eighty-five children were randomized blindly to methotrexate ( MTX ) , etanercept , and rapidly tapered prednisolone ( MEP ) or MTX monotherapy and assessed for CID over 1 year of treatment .
METHODS	Patients who failed to achieve intermediary endpoints were switched to open-label MEP treatment .
RESULTS	Fifty-eight ( 68.2 % ) of the 85 patients achieved CID at 1 or more visits including 18 who received blinded MEP , 11 while receiving MTX monotherapy , and 29 while receiving open-label MEP .
RESULTS	Patients starting on MEP achieved CID earlier and had more study days in CID compared to those starting MTX , but the differences were not significantly different .
RESULTS	Patients given MEP ( more aggressive therapy ) earlier in the disease course were statistically more likely to have a higher proportion of followup visits in CID than those with longer disease course at baseline .
RESULTS	Those who achieved American College of Rheumatology Pediatric 70 response at 4 months had a significantly greater proportion of followup visits in CID , compared to those who failed to achieve this improvement ( p < 0.0001 ) .
RESULTS	Of the 32 patients who met criteria for CID and then lost CID status , only 3 fulfilled the definition of disease flare .
CONCLUSIONS	Shorter disease duration prior to treatment , a robust response at 4 months , and more aggressive therapy result in a higher likelihood and longer duration of CID in patients with poly-JIA .
CONCLUSIONS	The original trial from which data for this analysis were obtained is registered on www.clinicaltrials.gov NCT 00443430 .

###24948384
OBJECTIVE	A high level of parental control of feeding and disturbed energy self-regulation has previously been suggested as a mechanism for the accelerated growth observed in formula-fed compared with breast-fed infants .
OBJECTIVE	This study explored factors associated with parental control of feeding in a population of formula-fed infants with high levels of self-regulation .
METHODS	We included 141 formula-fed and 72 breast-fed infants from a randomised controlled trial , who were prospectively followed from under 2months of age to 12months of age .
METHODS	Anthropometry was recorded at baseline , 4 , 6 and 12months of age .
METHODS	Parental feeding control was assessed using a Child Feeding Questionnaire at 4 and 12months .
RESULTS	The formula-fed groups fully compensated for different energy and protein densities by regulating their volume intakes .
RESULTS	Parents of formula-fed infants had a lower pressure to eat score at 12months than parents of breast-fed infants .
RESULTS	A high parental restrictive score at 12months was associated with weight at 12months and high parental pressure to eat score at 12months with body mass index at 12months .
RESULTS	Neither were associated with feeding mode .
CONCLUSIONS	Formula-fed infants had a high level of energy self-regulation and were subjected to low parental control .
CONCLUSIONS	Parental control of feeding was mainly influenced by infant growth .

###25706340
OBJECTIVE	Reminder/recall notifications used by primary care practices increase the rates of childhood immunizations , but fewer than 20 % of primary care practitioners nationally deliver such reminders .
OBJECTIVE	A reminder/recall notification conducted centrally by health departments in collaboration with primary care practices may reduce practice burden , reach children without a primary care practitioner , and decrease the cost of reminders/recalls .
OBJECTIVE	To assess the effectiveness and cost-effectiveness of collaborative centralized ( CC ) vs practice-based ( PB ) reminder/recall approaches using the Colorado Immunization Information System ( CIIS ) .
METHODS	We performed a randomized pragmatic trial from September 7 , 2012 , through March 17 , 2013 , including 18,235 children aged 19 to 35 months in 15 Colorado counties .
METHODS	In CC counties , children who needed at least 1 immunization were sent as many as 4 reminders/recalls by mail or autodialed telephone calls by the CIIS .
METHODS	Primary care practices in these counties were given the option of endorsing the reminder/recall notification by adding the practice name to the message .
METHODS	In PB counties , primary care practices were invited to web-based reminder/recall training and offered financial support for sending notifications .
METHODS	Documentation of any new immunization within 6 months constituted the primary outcome ; achieving up-to-date ( UTD ) immunization status was secondary .
METHODS	We assessed the cost and cost-effectiveness of each approach and used a generalized linear mixed-effects model to assess the effect of the intervention on outcomes .
RESULTS	In PB counties , 24 of 308 primary care practices ( 7.8 % ) attended reminder/recall training and 2 primary care practices ( 0.6 % ) endorsed reminder/recall notifications .
RESULTS	Within CC counties , 129 of 229 practices ( 56.3 % ) endorsed the reminder/recall letter .
RESULTS	Documentation rates for at least 1 immunization were 26.9 % for CC vs 21.7 % for PB counties ( P < .001 ) ; 12.8 % vs 9.3 % of patients , respectively , achieved UTD status ( P < .001 ) .
RESULTS	The effect of CC counties on children 's UTD status was greater when the reminder/recall notification was endorsed by the primary care practice ( 19.2 % vs 9.8 % ; P < .001 ) .
RESULTS	The total cost of the CC reminder/recall was $ 28620 or $ 11.75 per child for any new immunization and $ 24.72 per child achieving UTD status ; the total cost to the 2 practices that conducted PB reminders/recalls was $ 74.00 per child for any immunization and $ 124.45 per child achieving UTD status .
RESULTS	The modeling resulted in an adjusted odds ratio of 1.31 ( 95 % CI , 1.16-1 .48 ) for any new immunization in CC vs PB counties .
CONCLUSIONS	A CC reminder/recall notification was more effective and more cost-effective than a PB system , although the effect size was modest .
CONCLUSIONS	Endorsement by practices may further increase the effectiveness of CC reminder/recall .
BACKGROUND	clinicaltrials.gov Identifier : NCT01557621 .

###24581593
OBJECTIVE	To compare metal-induced artefacts from coiled intracranial aneurysms on 3.0-Tesla and 1.5-Tesla magnetic resonance angiography ( MRA ) , since concerns persist on artefact enlargement at 3.0 Tesla .
METHODS	We scanned 19 patients ( mean age 53 ; 16 women ) with 20 saccular aneurysms treated with coils only , at 1.5 and 3.0 Tesla according to standard clinical 3D TOF-MRA protocols containing a shorter echo-time but weaker read-out gradient at 3.0 Tesla in addition to intra-arterial digital subtraction angiography ( IA-DSA ) .
METHODS	Per modality two neuro-radiologists assessed the occlusion status , measured residual flow , and indicated whether coil artefacts disturbed this assessment on MRA .
METHODS	We assessed relative risks for disturbance by coil artefacts , weighted kappa 's for agreement on occlusion levels , and we compared remnant sizes .
METHODS	For artefact measurements , a coil model was created and scanned with the same protocols followed by 2D MR scans with variation of echo-time and read-out gradient strength .
RESULTS	Coil artefacts disturbed assessments less frequently at 3.0 Tesla than at 1.5 Tesla ( RR : 0.3 ; 95 % CI : 0.1-0 .8 ) .
RESULTS	On 3.0-Tesla MRA , remnants were larger than on 1.5-Tesla MRA ( difference : 0.7 mm ; 95 % CI : 0.3-1 .1 ) and larger than on IA-DSA ( difference : 1.0 mm ; 95 % CI : 0.6-1 .5 ) with similar agreement on occlusion levels with IA-DSA for both field strengths ( 0.53 ; 95 % CI : 0.23-0 .84 for 1.5-Tesla MRA and IA-DSA ; 0.47 ; 95 % CI : 0.19-0 .76 for 3.0-Tesla MRA and IA-DSA ) .
RESULTS	Coil model artefacts were smaller at 3.0 Tesla than at 1.5 Tesla .
RESULTS	The echo-time influenced artefact size more than the read-out gradient .
CONCLUSIONS	Artefacts were not larger , but smaller at 3.0 Tesla because a shorter echo-time at 3.0 Tesla negated artefact enlargement .
CONCLUSIONS	Despite smaller artefacts and larger remnants at 3.0 Tesla , occlusion levels were similar for both field strengths .

###25515105
OBJECTIVE	To better understand the sometimes catastrophic effects of sleep loss on naturalistic decision making , we investigated effects of sleep deprivation on decision making in a reversal learning paradigm requiring acquisition and updating of information based on outcome feedback .
METHODS	Subjects were randomized to a sleep deprivation or control condition , with performance testing at baseline , after 2 nights of total sleep deprivation ( or rested control ) , and following 2 nights of recovery sleep .
METHODS	Subjects performed a decision task involving initial learning of go and no go response sets followed by unannounced reversal of contingencies , requiring use of outcome feedback for decisions .
METHODS	A working memory scanning task and psychomotor vigilance test were also administered .
METHODS	Six consecutive days and nights in a controlled laboratory environment with continuous behavioral monitoring .
METHODS	Twenty-six subjects ( 22-40 y of age ; 10 women ) .
METHODS	Thirteen subjects were randomized to a 62-h total sleep deprivation condition ; the others were controls .
RESULTS	Unlike controls , sleep deprived subjects had difficulty with initial learning of go and no go stimuli sets and had profound impairment adapting to reversal .
RESULTS	Skin conductance responses to outcome feedback were diminished , indicating blunted affective reactions to feedback accompanying sleep deprivation .
RESULTS	Working memory scanning performance was not significantly affected by sleep deprivation .
RESULTS	And although sleep deprived subjects showed expected attentional lapses , these could not account for impairments in reversal learning decision making .
CONCLUSIONS	Sleep deprivation is particularly problematic for decision making involving uncertainty and unexpected change .
CONCLUSIONS	Blunted reactions to feedback while sleep deprived underlie failures to adapt to uncertainty and changing contingencies .
CONCLUSIONS	Thus , an error may register , but with diminished effect because of reduced affective valence of the feedback or because the feedback is not cognitively bound with the choice .
CONCLUSIONS	This has important implications for understanding and managing sleep loss-induced cognitive impairment in emergency response , disaster management , military operations , and other dynamic real-world settings with uncertain outcomes and imperfect information .

###24937669
BACKGROUND	Transcatheter arterial chemoembolisation ( TACE ) is the treatment of choice for intermediate stage hepatocellular carcinoma ( HCC ) .
BACKGROUND	Doxorubicin-loaded drug-eluting beads ( DEB ) - TACE is expected to improve the performance of conventional TACE ( cTACE ) .
BACKGROUND	The aim of this study was to compare DEB-TACE with cTACE in terms of time-to-tumour progression ( TTP ) , adverse events ( AEs ) , and 2-year survival .
METHODS	Patients were randomised one-to-one to undergo cTACE or DEB-TACE and followed-up for at least 2 years or until death .
METHODS	Transcatheter arterial chemoembolisation was repeated ` on-demand ' .
RESULTS	We enrolled 177 patients : 89 underwent DEB-TACE and 88 cTACE .
RESULTS	The median number of procedures was 2 in each arm , and the in-hospital stay was 3 and 4 days , respectively ( P = 0.323 ) .
RESULTS	No differences were found in local and overall tumour response .
RESULTS	The median TTP was 9 months in both arms .
RESULTS	The AE incidence and severity did not differ between the arms , except for post-procedural pain , more frequent and severe after cTACE ( P < 0.001 ) .
RESULTS	The 1 - and 2-year survival rates were 86.2 % and 56.8 % after DEB-TACE and 83.5 % and 55.4 % after cTACE ( P = 0.949 ) .
RESULTS	Eastern Cooperative Oncology Group ( ECOG ) , serum albumin , and tumour number independently predicted survival ( P < 0.05 ) .
CONCLUSIONS	The DEB-TACE and the cTACE are equally effective and safe , with the only advantage of DEB-TACE being less post-procedural abdominal pain .

###24943741
OBJECTIVE	Randomized controlled trials ( RCTs ) are widely used in health care research to provide high-quality evidence of effectiveness of an intervention .
OBJECTIVE	However , sometimes a study does not require an RCT in order to answer its primary objective ; a case-finding design may be more appropriate .
OBJECTIVE	The aim of this paper was to introduce a new study design that nests a waiting list RCT within a case-finding study .
METHODS	An example of the new study design is the DOC Study , which primarily aims to determine the diagnostic accuracy of lung function tests for chronic obstructive pulmonary disease .
METHODS	It also investigates the impact of lung function tests on smoking behaviour through use of a waiting list design .
METHODS	The first step of the study design is to obtain participants ' consent .
METHODS	Individuals are then randomized to one of two groups ; either the ` intervention now ' group or the ` intervention later ' group , that is , participants are placed on a waiting list .
METHODS	All participants receive the same intervention ; the only difference between the groups is the timing of the intervention .
CONCLUSIONS	The design addresses patient preference issues and recruitment issues that can arise in other trial designs .
CONCLUSIONS	Potential limitations include differential attrition between study groups and potential demoralization for the ` intervention later ' group .
CONCLUSIONS	The ` waiting list case-finding trial ' design is a valuable method that could be applied to case-finding studies ; the design enables the case-finding component of a study to be maintained while simultaneously exploring additional hypotheses through conducting a trial .

###25257978
BACKGROUND	Social support has been linked to quitting smoking , but the mechanisms by which social support affects cessation are poorly understood .
BACKGROUND	The current study tested a stress-buffering model of social support , which posits that social support protects or `` buffers '' individuals from stress related to quitting smoking .
BACKGROUND	We hypothesized that social support would be negatively associated with risk of relapse , and that this effect would be mediated by reduced withdrawal and depressive symptoms ( i.e. , cessation-related stress ) over time .
BACKGROUND	Further , we predicted that trait neuroticism would moderate this mediational effect , such that individuals high in negative affectivity would show the greatest stress-buffering effects of social support .
METHODS	Participants were weight-concerned women ( n = 349 ) ages 18-65 enrolled in a randomized , double-blind , placebo-controlled smoking cessation trial of bupropion and cognitive behavioral therapy .
METHODS	Social support was assessed at baseline , and biochemically-verified abstinence , withdrawal-related symptoms , and depressive symptoms were assessed at 1 - , 3 - , 6 - , and 12-months follow-up .
RESULTS	Social support was negatively related to risk of relapse in survival models and negatively related to withdrawal symptoms and depression in mixed effects models .
RESULTS	These relationships held after controlling for the effects of pre-quit day negative affect and depression symptoms , assignment to treatment condition , and number of cigarettes smoked per day .
RESULTS	A temporal mediation model showed that the effect of social support on risk of relapse was mediated by reductions in withdrawal symptoms over time but not by depression over time .
RESULTS	Contrary to hypotheses , we did not find that neuroticism moderated this mediation effect .
CONCLUSIONS	Increased social support may buffer women from the harmful effects of cessation-related withdrawal symptoms , which in turn improve cessation outcomes .

###24643119
OBJECTIVE	Repetitive transcranial magnetic stimulation ( rTMS ) is a noninvasive , safe and efficacious technique for treating various neuropsychiatric disorders , but its underlying mechanisms are poorly understood .
OBJECTIVE	A newly developed H-coil allows the stimulation of deeper brain regions .
OBJECTIVE	This study is the first to investigate the effects of deep high-frequency rTMS on brain-derived neurotrophic factor ( BDNF ) serum concentrations in healthy volunteers .
OBJECTIVE	We aimed to evaluate the short-term effect of deep rTMS on BDNF serum concentrations .
METHODS	This was a double-blind , randomized deep high-frequency rTMS study using an H-coil on a cohort of 13 healthy volunteers ( NCT01106365 ) .
METHODS	The following stimulation protocols were applied : 18-Hz stimulation of the left dorsolateral prefrontal cortex ( PFC ) , 5-Hz stimulation of the primary motor cortex ( MC ) and sham stimulation in random order .
METHODS	Blood samples were obtained before , 30 min after and 60 min after each treatment .
RESULTS	The BDNF serum concentration decreased significantly after MC and PFC stimulation , but not after sham stimulation .
RESULTS	Furthermore , BDNF serum level changes were associated with changes in individual alertness .
CONCLUSIONS	Although BDNF serum concentrations do not necessarily correlate with BDNF levels in the cerebrospinal fluid or the brain , these results indicate an acute biological effect of deep rTMS on BDNF release , and demonstrate that this change correlates with alertness .

###25085109
BACKGROUND	18F-FDG PET can be used to aid in the diagnosis of Alzheimer 's disease ( AD ) and clarify the diagnosis and prognosis of patients with mild cognitive impairment ( MCI ) .
OBJECTIVE	To compare the results of a quantitative analysis of FDG-PET brain images to a standard visual analysis ( SVA ) with regards to the detection of MCI-like hypometabolic pattern in elderly patients with hypertension and subjective , isolated memory complaints .
METHODS	FDG-PET brain was performed in 71 patients ( mean age , 76.4 5.1 years ; women , 53.5 % ) .
METHODS	Images were analyzed for the presence of an MCI-like hypometabolic pattern using an SVA by 2 physicians and a voxel-based statistical procedure ( statistical parametric mapping [ SPM ] ) that compared each patient 's images to normal reference samples from 19 elderly individuals obtained using the same PET camera .
METHODS	The reliability of these analyses was evaluated according to neuropsychological assessment results , including the Grober & Buschke Free and Cued Selective Reminding Test , and a combined analysis by a neuropsychologist .
RESULTS	An MCI-like hypometabolic pattern was documented in 5 patients ( 7 % ) by SVA and 7 patients ( 10 % ) by SPM analysis ; however , only 2 of these patients were selected by both methods .
RESULTS	The group characteristics of the 7 patients identified by the quantitative method were consistent with the MCI pattern , which included a higher rate of abnormal GB-FCSRT in Free Recall ( 57 % vs. 9 % , p < 0.05 ) or in Total Recall ( 29 % vs. 8 % , p < 0.05 ) when compared with other patients .
RESULTS	In contrast , the group identified by SVA did not exhibit these characteristics .
CONCLUSIONS	A combined visual and quantitative analysis improves the diagnostic accuracy to detect an MCI-like hypometabolic pattern in elderly patients with hypertension and subjective , isolated memory complaints .

###24713286
OBJECTIVE	To evaluate the effects of compound whole grain-soybean on insulin resistance and serum adipocytokines levels in impared fasting glucose population .
METHODS	According to inclusion and exclusion criteria , 163 cases of impared fasting glucose ( IFG ) Chinese Han population from the age of 40 to 75 years old , were screened from 12 community health centers of three main districts of Nanjing city by the multi-stage cluster and simple randomization method from March to September , 2008 .
METHODS	The IFG subjects were randomly divided into the intervention group ( 87 individuals ) and control group ( 76 individuals ) by quasi-experimental design .
METHODS	The intervention group was provided with compound whole grain-soybean and health education , while only health education was provided for the control group .
METHODS	Body mass index ( BMI ) , waist-to-hip ratio ( WHR ) , lipid profiles , fasting blood glucose ( FBG ) , fasting insulin ( FINS ) and homeostasis model assessment of insulin resistance ( HOMA-IR ) , adipocytokines including leptin , lipocalin 2 ( LCN-2 ) and adiponectin ( ADP ) levels were measured before and after the half a year intervention period .
METHODS	Chi square test was used to analyze the distribution differences .
METHODS	Two-sample t-test was used to compare the differences of the two groups before and after the half a year intervention period , and paired t-test was used to compare the differences between before and after intervention in the intervention group or control group .
METHODS	Wilcoxon rank sum test was used to compare the differences of all indexes between after and before dietary intervention .
RESULTS	After dietary intervention for half a year on the IFG population , BMI ( ( 24.87 3.69 ) kg/m ( 2 ) ) , FBG ( ( 6.27 0.24 ) mmol/L ) , FINS ( ( 7.14 1.05 ) mU/L ) , HOMA-IR ( 1.99 0.31 ) , leptin ( ( 13.07 2.22 ) g / L ) , LCN-2 ( ( 67.42 18.20 ) g/L ) of intervention group were decreased significantly compared to the levels of BMI ( ( 25.16 4.07 ) kg/m ( 2 ) ) , FBG ( ( 6.40 0.28 ) mmol/L ) , FINS ( ( 7.32 1.54 ) mU/L ) , HOMA-IR ( 2.08 0.45 ) , leptin ( ( 13.43 2.52 ) g/L ) , LCN-2 ( ( 74.87 17.81 ) g/L ) before dietary intervention , t values were 4.48 , 7.08 , 2.05 , 3.39 , 3.28 and 6.36 , respectively , and all P values were < 0.05 , while ADP ( ( 5.07 1.51 ) mg/L ) of intervention group after dietary intervention was increased significantly compared to the level of ADP ( ( 4.92 1.53 ) mg/L ) before dietary intervention , t = -2.47 and P < 0.05 .
RESULTS	The medians ( P25 , P 75 ) of differences after and before dietary intervention in the intervention group were BMI ( -0.25 ( -0.68 , 0.02 ) kg/m ( 2 ) ) , FBG ( -0.08 ( -0.20 , 0.00 ) mmol/L ) , FINS ( -0.15 ( -0.32 , 0.00 ) mU/L ) , HOMA-IR ( -0.07 ( -0.12 , -0.03 ) ) , leptin ( -0.36 ( -0.77 , 0.12 ) g/L ) , LCN-2 ( -5.85 ( -14.29 , -0.71 ) g/L ) and ADP ( 0.15 ( -0.13 , 0.36 ) mg/L ) , and the medians of differences of after and before dietary intervention in the control group were BMI ( 0.00 ( -0.23 , 0.29 ) kg/m ( 2 ) ) , FBG ( 0.00 ( -0.03 , 0.04 ) mmol/L ) , FINS ( -0.01 ( -0.13 , 0.04 ) mU/L ) , HOMA-IR ( -0.01 ( -0.05 , 0.02 ) ) , leptin ( -0.07 ( -0.57 , 0.46 ) g/L ) , LCN-2 ( -0.85 ( -5.39 , 1.63 ) g/L ) and ADP ( 0.02 ( -0.19 , 0.13 ) mg/L ) .
RESULTS	There were significantly statistical differences between them ( Z values were -3.65 , -4.88 , -3.08 , -5.23 , -2.16 , -4.43 and 3.05 , all P values were < 0.05 ) .
CONCLUSIONS	Dietary intervention of compound whole grain-soybean can improves glucose level , increase insulin sensitivity and ameliorate insulin resistance state of IFG population .

###24846036
OBJECTIVE	There is limited evidence supporting use of physical therapy for hip osteoarthritis .
OBJECTIVE	To determine efficacy of physical therapy on pain and physical function in patients with hip osteoarthritis .
METHODS	Randomized , placebo-controlled , participant - and assessor-blinded trial involving 102 community volunteers with hip pain levels of 40 or higher on a visual analog scale of 100 mm ( range , 0-100 mm ; 100 indicates worst pain possible ) and hip osteoarthritis confirmed by radiograph .
METHODS	Forty-nine patients in the active group and 53 in the sham group underwent 12 weeks of intervention and 24 weeks of follow-up ( May 2010-February 2013 ) INTERVENTIONS : Participants attended 10 treatment sessions over 12 weeks .
METHODS	Active treatment included education and advice , manual therapy , home exercise , and gait aid if appropriate .
METHODS	Sham treatment included inactive ultrasound and inert gel .
METHODS	For 24 weeks after treatment , the active group continued unsupervised home exercise while the sham group self-applied gel 3 times weekly .
METHODS	Primary outcomes were average pain ( 0 mm , no pain ; 100 mm , worst pain possible ) and physical function ( Western Ontario and McMaster Universities Osteoarthritis Index , 0 no difficulty to 68 extreme difficulty ) at week 13 .
METHODS	Secondary outcomes were these measures at week 36 and impairments , physical performance , global change , psychological status , and quality of life at weeks 13 and 36 .
RESULTS	Ninety-six patients ( 94 % ) completed week 13 measurements and 83 ( 81 % ) completed week 36 measurements .
RESULTS	The between-group differences for improvements in pain were not significant .
RESULTS	For the active group , the baseline mean ( SD ) visual analog scale score was 58.8 mm ( 13.3 ) and the week-13 score was 40.1 mm ( 24.6 ) ; for the sham group , the baseline score was 58.0 mm ( 11.6 ) and the week-13 score was 35.2 mm ( 21.4 ) .
RESULTS	The mean difference was 6.9 mm favoring sham treatment ( 95 % CI , -3.9 to 17.7 ) .
RESULTS	The function scores were not significantly different between groups .
RESULTS	The baseline mean ( SD ) physical function score for the active group was 32.3 ( 9.2 ) and the week-13 score was 27.5 ( 12.9 ) units , whereas the baseline score for the sham treatment group was 32.4 ( 8.4 ) units and the week-13 score was 26.4 ( 11.3 ) units , for a mean difference of 1.4 units favoring sham ( 95 % CI , -3.8 to 6.5 ) at week 13 .
RESULTS	There were no between-group differences in secondary outcomes ( except greater week-13 improvement in the balance step test in the active group ) .
RESULTS	Nineteen of 46 patients ( 41 % ) in the active group reported 26 mild adverse effects and 7 of 49 ( 14 % ) in the sham group reported 9 mild adverse events ( P = .003 ) .
CONCLUSIONS	Among adults with painful hip osteoarthritis , physical therapy did not result in greater improvement in pain or function compared with sham treatment , raising questions about its value for these patients .
BACKGROUND	anzctr.org.au Identifier : ACTRN12610000439044 .

###24697789
OBJECTIVE	To determine whether antibiotic prescribing can be reduced in nursing homes using a quality improvement ( QI ) program that involves providers , staff , residents , and families .
METHODS	A 9-month quasi-experimental trial of a QI program in 12 nursing homes ( 6 comparison , 6 intervention ) conducted from March to November 2011 .
METHODS	Nursing homes in two regions of North Carolina , roughly half of whose residents received care from a single practice of long-term care providers .
METHODS	All residents , including 1,497 who were prescribed antibiotics .
METHODS	In the intervention sites , providers in the single practice and nursing home nurses received training related to prescribing guidelines , including situations for which antibiotics are generally not indicated , and nursing home residents and their families were sensitized to matters related to antibiotic prescribing .
METHODS	Feedback on prescribing was shared with providers and nursing home staff monthly .
METHODS	Rates of antibiotic prescribing for presumed urinary tract , skin and soft tissue , and respiratory infections .
RESULTS	The QI program reduced the number of prescriptions ordered between baseline and follow-up more in intervention than in comparison nursing homes ( adjusted incidence rate ratio = 0.86 , 95 % confidence interval = 0.79-0 .95 ) .
RESULTS	Based on baseline prescribing rates of 12.95 prescriptions per 1,000 resident-days , this estimated adjusted incidence rate ratio implies 1.8 prescriptions avoided per 1,000 resident-days .
CONCLUSIONS	This magnitude of effect is unusual in efforts to reduce antibiotic use in nursing homes .
CONCLUSIONS	Outcomes could be attributed to the commitment of the providers ; outreach to providers and staff ; and a focus on common clinical situations in which antibiotics are generally not indicated ; and suggest that similar results can be achieved on a wider scale if similar commitment is obtained and education provided .

###25252490
OBJECTIVE	To assess the efficacy of drugs containing herbal extracts in the treatment of Benign Prostatic Hyperplasia .
METHODS	The clinical trial study was performed in 2011-2012 at Imam Reza Hospital , Mashhad , Iran .
METHODS	One hundred patients with Benign Prostatic Hyperplasia were randomly divided into 2 equal groups receiving prostafit and prazosin , respectively .
METHODS	Quality of life and International Prostatic Symptom Score questionnaire were filled and prostate specific antigen level , uroflowmetry and prostate volume were measured at baseline , 3 and 6 months after the medication .
METHODS	The data was analysed using SPSS 15 and repeated measure analysis of variance .
RESULTS	No complications were observed during and after the treatment .
RESULTS	International Prostatic Symptom Score had significant differences at baseline and 6 months after the treatment in both groups , specially in group 2 18 vs 22 ( 36 % versus 44 % ) .
RESULTS	Quality of life was better in group 2 , 25.5 vs 31.5 ( 51 % versus 63 % ) .
RESULTS	prostate specific antigen level did not change after the treatment and there was no remarkable difference in either group .
CONCLUSIONS	Prostafit is an effective and safe treatment in Benign Prostatic Hyperplasia but not as much as prozasin .

###25752386
OBJECTIVE	Image-guided intensity modulated radiation therapy ( IG-IMRT ) allows significant dose reductions to organs at risk in prostate cancer patients .
OBJECTIVE	However , clinical data identifying the benefits of IG-IMRT in daily practice are scarce .
OBJECTIVE	The purpose of this study was to compare dose distributions to organs at risk and acute gastrointestinal ( GI ) and genitourinary ( GU ) toxicity levels of patients treated to 78 Gy with either IG-IMRT or 3D-CRT .
METHODS	Patients treated with 3D-CRT ( n = 215 ) and IG-IMRT ( n = 260 ) receiving 78 Gy in 39 fractions within 2 randomized trials were selected .
METHODS	Dose surface histograms of anorectum , anal canal , and bladder were calculated .
METHODS	Identical toxicity questionnaires were distributed at baseline , prior to fraction 20 and 30 and at 90 days after treatment .
METHODS	Radiation Therapy Oncology Group ( RTOG ) grade 1 , 2 , and 3 endpoints were derived directly from questionnaires .
METHODS	Univariate and multivariate binary logistic regression analyses were applied .
RESULTS	The median volumes receiving 5 to 75 Gy were significantly lower ( all P < .001 ) with IG-IMRT for anorectum , anal canal , and bladder .
RESULTS	The mean dose to the anorectum was 34.4 Gy versus 47.3 Gy ( P < .001 ) , 23.6 Gy versus 44.6 Gy for the anal canal ( P < .001 ) , and 33.1 Gy versus 43.2 Gy for the bladder ( P < .001 ) .
RESULTS	Significantly lower grade 2 toxicity was observed for proctitis , stool frequency 6/day , and urinary frequency 12/day .
RESULTS	IG-IMRT resulted in significantly lower overall RTOG grade 2 GI toxicity ( 29 % vs 49 % , respectively , P = .002 ) and overall GU grade 2 toxicity ( 38 % vs 48 % , respectively , P = .009 ) .
CONCLUSIONS	A clinically meaningful reduction in dose to organs at risk and acute toxicity levels was observed in IG-IMRT patients , as a result of improved technique and tighter margins .
CONCLUSIONS	Therefore reduced late toxicity levels can be expected as well ; additional research is needed to quantify such reductions .

###24668456
OBJECTIVE	To assess the possible predictive factors for permanent laryngoplasty ( PL ) in patients with acute unilateral vocal fold paralysis ( UVFP ) , and to assess the effects of early vocal cord hyaluronic acid injection .
METHODS	Prospective cohort study .
METHODS	Patients diagnosed with UVFP within the previous 6 months were enrolled .
METHODS	Initial and follow-up videolaryngostroboscopy , voice laboratory analysis , laryngeal electromyography , and Voice Outcome Survey were performed .
RESULTS	Fifty newly diagnosed UVFP patients were recruited .
RESULTS	Eight were excluded after 12 months of follow-up and data for 42 patients were analyzed .
RESULTS	In patients treated conservatively , the glottal gap was measured on presentation .
RESULTS	Normalized glottal gap area ( NGGA ) was the only predictor of PL ( P = 0.036 ) according to multivariate logistic regression analysis .
RESULTS	A cutoff value of 7.36 resulted in sensitivity of 85.7 % and specificity of 80.0 % for predicting future PL .
RESULTS	The PL rate was significantly higher in patients with an initial NGGA > 7.36 compared with 7.36 .
RESULTS	( 6/9 vs. 1/13 ; ( 2 ) = 6.71 ; P = 0.010 ) .
RESULTS	Among patients with an initial NGGA > 7.36 , those who accepted early hyaluronic acid injection had a significantly lower rate of PL ( 1/11 vs. 6/9 ; ( 2 ) = 7.21 ; P = 0.007 ) and better social and emotional role functioning at follow-up .
CONCLUSIONS	The glottal gap on presentation is a robust early predictor of PL .
CONCLUSIONS	Early , office-based hyaluronic acid intracordal injection can reduce the need for PL in patients with a large NGGA .

###26156743
BACKGROUND	The role of folate in skin carcinogenesis is unclear , with experimental data suggesting potentially protective but also deleterious effects .
OBJECTIVE	Our main objective was to investigate the prospective association between dietary folate intake and risks of skin cancer ( overall ) , nonmelanoma skin cancer ( NMSC ) , and basal cell carcinoma ( BCC ) .
OBJECTIVE	As an exploratory analysis , we also investigated the prospective association between erythrocyte folate concentration and skin cancer risk .
METHODS	In this study , we included 5880 participants in the Supplmentation en Vitamines et Minraux Antioxydants ( SU.VI.MAX ) cohort ( follow-up : 1994-2007 ) who completed at least six 24-h dietary records during the first 2 y of the study .
METHODS	Associations between sex-specific tertiles of dietary and erythrocyte folate and skin cancer risk were assessed by using multivariate Cox proportional hazards models .
RESULTS	After a median follow-up of 12.6 y , 144 incident skin cancers were diagnosed .
RESULTS	Dietary folate intake was associated with increased risk of overall skin cancer [ HR for tertile 3 compared with tertile 1 ( HR ( T3vs.T1 ) ) : 1.79 ; 95 % CI : 1.07 , 2.99 ; P-trend = 0.03 ] , NMSC ( HR ( T3vs.T1 ) : 1.85 ; 95 % CI : 1.06 , 3.23 ; P-trend = 0.03 ) , and BCC ( HR ( T3vs.T1 ) : 1.78 ; 0.98 , 3.24 ; P-trend = 0.05 ) .
RESULTS	This association was observed in women ( corresponding P-trend = 0.007 , 0.009 , and 0.009 , respectively ) but not in men ( P-trend = 0.8 , 0.8 , and 0.9 , respectively ) .
RESULTS	P-interaction values between tertiles of dietary folate intake and sex were 0.04 , 0.02 , and 0.02 for overall skin cancer , NMSC , and BCC , respectively .
RESULTS	Erythrocyte folate concentration was directly associated with increased risk of overall skin cancer ( HR ( T3vs.T1 ) : 2.54 ; 95 % CI : 0.95 , 6.81 ; P-trend = 0.03 ) , NMSC ( HR ( T3vs.T1 ) : 3.49 ; 95 % CI : 1.11 , 11.0 ; P-trend = 0.01 ) , and BCC ( HR ( T3vs.T1 ) : 7.44 ; 95 % CI : 1.57 , 35.3 ; P-trend = 0.004 ) ( men and women combined ) .
CONCLUSIONS	This prospective study suggests an association between dietary folate intake and erythrocyte folate concentration and increased risk of overall skin cancer , NMSC , and BCC .
CONCLUSIONS	Although several mechanistic hypotheses and 2 previous large prospective studies on BCC are in line with these results , epidemiologic literature is limited , and future research is needed to better elucidate the potential role of folate in the cause of skin cancers .

###24335445
OBJECTIVE	This trial compared the efficacy/safety of two IV doses of AZD9773 , a polyclonal antibody to tumor necrosis factor - , in adult patients with severe sepsis/septic shock .
METHODS	Multicenter , randomized , double-blind , placebo-controlled phase IIb trial .
METHODS	ICUs in seven countries ( Australia , Belgium , Canada , Czech Republic , Finland , France , and Spain ) .
METHODS	Patients 18 years old or older with severe sepsis and/or septic shock .
METHODS	Patients were required to have 1 ) objective clinical evidence of infection ; 2 ) at least two of four systemic inflammatory response syndrome criteria ; and 3 ) cardiovascular and/or respiratory sepsis-related failure .
METHODS	Patients were randomized 1:1:1 to a single loading infusion of AZD9773 250 U/kg followed by 50 U/kg every 12 hours ( low dose , n = 100 ) , a single loading infusion of AZD9773 500 U/kg followed by 100 U/kg every 12 hours ( high dose , n = 100 ) , or placebo ( n = 100 ) for 5 days .
METHODS	Follow-up assessments were performed up to day 90 .
RESULTS	Mean number of ventilator-free days ( primary endpoint ) did not differ between low-dose ( 19.7 d ) or high-dose AZD9773 ( 17.3 d ) and placebo ( 18.3 d ) ( one-sided p = 0.18 and 0.74 , respectively ) .
RESULTS	Mortality rates were comparable across treatment groups ; relative risk of death versus placebo at day 29 was 0.80 for low-dose AZD9773 ( one-sided p = 0.25 ) and 1.64 for high-dose AZD9773 ( p = 0.97 ) .
RESULTS	Most patients experienced at least one treatment-emergent adverse event ( 87.8 % in AZD9773-treated patients , 92.9 % in placebo patients ) although most were mild/moderate in nature .
RESULTS	No differences in the incidence of adverse events or laboratory or vital sign abnormalities were observed between groups .
CONCLUSIONS	AZD9773 rapidly and efficiently decreased plasma tumor necrosis factor - concentration in patients with severe sepsis/septic shock , but this effect did not translate into clinical benefit .

###24618483
OBJECTIVE	To study the effectiveness of the addition of citicoline to patching in the treatment of amblyopia in the age group of 4-13 years .
METHODS	A randomized controlled trial , which included patients who were randomly divided into two groups .
METHODS	Both the groups received patching therapy till plateau was achieved in phase 1 of the study .
METHODS	Then in phase 2 , group I received citicoline plus patching and group II continued to receive only patching .
METHODS	Outcome was measured by the visual acuity in logMAR every month in phase 1 till plateau was achieved and then for 12 months in phase 2 .
RESULTS	No significant difference was found in the mean visual acuities in these two groups in phase 1 till plateau was reached .
RESULTS	In phase 2 , for the initial four months , there was no significant difference in the visual acuities in these two groups , at the respective intervals .
RESULTS	However , five months onward , up to 12 months , there was a significant difference in the visual acuities in these groups.The result was the same in younger patients ( < seven years of age ) as well as in older patients ( > seven years of age ) .
RESULTS	In phase 2 , the mean proportional improvement in group I was significantly more than that in group II , at two months and onward , at the respective intervals .
CONCLUSIONS	The improvement in visual acuity with citicoline plus patching was significantly more than that with patching alone , in one year of treatment .

###24519768
OBJECTIVE	To compare breast cancer incidence and mortality up to 25 years in women aged 40-59 who did or did not undergo mammography screening .
METHODS	Follow-up of randomised screening trial by centre coordinators , the study 's central office , and linkage to cancer registries and vital statistics databases .
METHODS	15 screening centres in six Canadian provinces,1980-85 ( Nova Scotia , Quebec , Ontario , Manitoba , Alberta , and British Columbia ) .
METHODS	89,835 women , aged 40-59 , randomly assigned to mammography ( five annual mammography screens ) or control ( no mammography ) .
METHODS	Women aged 40-49 in the mammography arm and all women aged 50-59 in both arms received annual physical breast examinations .
METHODS	Women aged 40-49 in the control arm received a single examination followed by usual care in the community .
METHODS	Deaths from breast cancer .
RESULTS	During the five year screening period , 666 invasive breast cancers were diagnosed in the mammography arm ( n = 44,925 participants ) and 524 in the controls ( n = 44,910 ) , and of these , 180 women in the mammography arm and 171 women in the control arm died of breast cancer during the 25 year follow-up period .
RESULTS	The overall hazard ratio for death from breast cancer diagnosed during the screening period associated with mammography was 1.05 ( 95 % confidence interval 0.85 to 1.30 ) .
RESULTS	The findings for women aged 40-49 and 50-59 were almost identical .
RESULTS	During the entire study period , 3250 women in the mammography arm and 3133 in the control arm had a diagnosis of breast cancer , and 500 and 505 , respectively , died of breast cancer .
RESULTS	Thus the cumulative mortality from breast cancer was similar between women in the mammography arm and in the control arm ( hazard ratio 0.99 , 95 % confidence interval 0.88 to 1.12 ) .
RESULTS	After 15 years of follow-up a residual excess of 106 cancers was observed in the mammography arm , attributable to over-diagnosis .
CONCLUSIONS	Annual mammography in women aged 40-59 does not reduce mortality from breast cancer beyond that of physical examination or usual care when adjuvant therapy for breast cancer is freely available .
CONCLUSIONS	Overall , 22 % ( 106/484 ) of screen detected invasive breast cancers were over-diagnosed , representing one over-diagnosed breast cancer for every 424 women who received mammography screening in the trial .

###24949421
BACKGROUND	The aim of this study was to evaluate the compatibility of external measurements of parameters characterizing scoliosis using the photogrammetric method .
METHODS	The study involved 120 children between the ages of 7 and 11 years in Podkarpackie ( Poland ) .
METHODS	Measurements of body posture characteristics were performed using the photogrammetric method with mora projection .
METHODS	Each person was examined twice , once by two different therapists , with a time lapse of 20 minutes in between examinations .
RESULTS	High accuracy and no statistical significance were found among different measurements of asymmetry parameters characterizing the shoulder blades and hips .
RESULTS	Regularities were also found in the characteristic measurements of curves of scoliosis .
RESULTS	The POSTI parameter showed a significant variation and lack of compatibility of results .
CONCLUSIONS	( 1 ) The photogrammetric method used to assess the pathological changes caused by scoliosis gives significant results in terms of parameters characterizing the position of the shoulder blades and shoulders , as well as pelvis rotation .
CONCLUSIONS	( 2 ) High compliance measurements are also characterized by the length of the right and left arcs of scoliosis .

###24836312
BACKGROUND	In two of three phase 3 trials , pirfenidone , an oral antifibrotic therapy , reduced disease progression , as measured by the decline in forced vital capacity ( FVC ) or vital capacity , in patients with idiopathic pulmonary fibrosis ; in the third trial , this end point was not achieved .
BACKGROUND	We sought to confirm the beneficial effect of pirfenidone on disease progression in such patients .
METHODS	In this phase 3 study , we randomly assigned 555 patients with idiopathic pulmonary fibrosis to receive either oral pirfenidone ( 2403 mg per day ) or placebo for 52 weeks .
METHODS	The primary end point was the change in FVC or death at week 52 .
METHODS	Secondary end points were the 6-minute walk distance , progression-free survival , dyspnea , and death from any cause or from idiopathic pulmonary fibrosis .
RESULTS	In the pirfenidone group , as compared with the placebo group , there was a relative reduction of 47.9 % in the proportion of patients who had an absolute decline of 10 percentage points or more in the percentage of the predicted FVC or who died ; there was also a relative increase of 132.5 % in the proportion of patients with no decline in FVC ( P < 0.001 ) .
RESULTS	Pirfenidone reduced the decline in the 6-minute walk distance ( P = 0.04 ) and improved progression-free survival ( P < 0.001 ) .
RESULTS	There was no significant between-group difference in dyspnea scores ( P = 0.16 ) or in rates of death from any cause ( P = 0.10 ) or from idiopathic pulmonary fibrosis ( P = 0.23 ) .
RESULTS	However , in a prespecified pooled analysis incorporating results from two previous phase 3 trials , the between-group difference favoring pirfenidone was significant for death from any cause ( P = 0.01 ) and from idiopathic pulmonary fibrosis ( P = 0.006 ) .
RESULTS	Gastrointestinal and skin-related adverse events were more common in the pirfenidone group than in the placebo group but rarely led to treatment discontinuation .
CONCLUSIONS	Pirfenidone , as compared with placebo , reduced disease progression , as reflected by lung function , exercise tolerance , and progression-free survival , in patients with idiopathic pulmonary fibrosis .
CONCLUSIONS	Treatment was associated with an acceptable side-effect profile and fewer deaths .
CONCLUSIONS	( Funded by InterMune ; ASCEND ClinicalTrials.gov number , NCT01366209 . )

###24461279
OBJECTIVE	This study examined the effects of preoperative incentive spirometry ( IS ) education ( POISE ) on postoperative outcomes for knee and hip total joint replacement patients .
METHODS	In this prospective study , 140 patients were randomized to Group 1 ( POISE intervention = 50 completing ) or Group 2 ( no intervention = 56 completing ) ( 34 dropped ) .
METHODS	The Group 1 intervention consisted of formal instruction preoperatively for IS home use , postoperative use , and IS volumes documentation .
METHODS	Group 2 patients received no intervention .
METHODS	Patients recorded postoperative IS volumes , which were used to determine return to baseline volume .
RESULTS	One hundred six patients completed the study .
RESULTS	Most were Caucasian females averaging 64 years .
RESULTS	Although IS return to baseline volume time was not significantly different between groups , POISE patients had fewer postoperative complications , hospital days , and charges .
RESULTS	POISE patients ranked the intervention as helpful .
CONCLUSIONS	Although IS volumes were not significantly different between groups , POISE patients had better outcomes and ranked the intervention as helpful .

###24355874
BACKGROUND	Acute pancreatitis is a severe condition that requires early identification of patients at risk of developing potentially lethal complications .
BACKGROUND	Current clinical scoring systems and biochemical parameters are insufficient .
BACKGROUND	In this study , we aimed to assess whether early plasma Angiopoietin-2 ( Ang-2 ) is associated with adverse outcomes in patients with predicted severe acute pancreatitis ( SAP ) .
METHODS	This analysis is a substudy of the PROPATRIA trial ( probiotics vs placebo in patients with predicted SAP ) .
METHODS	The Ang-2 levels were measured prospectively in plasma in the first 5 days after admission in 115 patients .
RESULTS	Early Ang-2 levels were higher in patients who developed SAP : 6.4 vs 3.1 g/L ( p < 0.001 ) and also were higher in patients who developed multiorgan failure in the first week ( p = 0.001 ) and after the first week ( p = 0.049 ) .
RESULTS	Furthermore , high Ang-2 levels were associated with infectious complications in the first week ( p < 0.001 ) and after the first week ( p < 0.001 ) .
RESULTS	Finally , plasma Ang-2 was significantly higher in patients who died ( p < 0.001 ) and in patients who developed bowel ischemia ( p < 0.001 ) .
RESULTS	As a predictor of adverse outcomes , plasma Ang-2 was superior to a number of current scores , such as the APACHE II score , the Imrie score , C-reactive protein , lipopolysaccharide binding protein , and procalcitonin .
CONCLUSIONS	In the setting of this randomized controlled trial , early plasma Ang-2 was found to be an accurate predictor of SAP , multiorgan failure , and infectious complications .
CONCLUSIONS	As a biomarker , it did outperform all of the investigated conventional predictors that are currently used in clinical practice .

###24834925
OBJECTIVE	To evaluate the interleukin-6 receptor inhibitor tocilizumab for the treatment of patients with polyarticular-course juvenile idiopathic arthritis ( pcJIA ) .
METHODS	This three-part , randomised , placebo-controlled , double-blind withdrawal study ( NCT00988221 ) included patients who had active pcJIA for 6months and inadequate responses to methotrexate .
METHODS	During part 1 , patients received open-label tocilizumab every 4weeks ( 8 or 10mg/kg for body weight ( BW ) < 30kg ; 8mg/kg for BW 30kg ) .
METHODS	At week 16 , patients with JIA-American College of Rheumatology ( ACR ) 30 improvement entered the 24-week , double-blind part 2 after randomisation 1:1 to placebo or tocilizumab ( stratified by methotrexate and steroid background therapy ) for evaluation of the primary end point : JIA flare , compared with week 16 .
METHODS	Patients flaring or completing part 2 received open-label tocilizumab .
RESULTS	In part 1 , 188 patients received tocilizumab ( < 30kg : 10mg/kg ( n = 35 ) or 8mg/kg ( n = 34 ) ; 30kg : n = 119 ) .
RESULTS	In part 2 , 163 patients received tocilizumab ( n = 82 ) or placebo ( n = 81 ) .
RESULTS	JIA flare occurred in 48.1 % of patients on placebo versus 25.6 % continuing tocilizumab ( difference in means adjusted for stratification : -0.21 ; 95 % CI -0.35 to -0.08 ; p = 0.0024 ) .
RESULTS	At the end of part 2 , 64.6 % and 45.1 % of patients receiving tocilizumab had JIA-ACR70 and JIA-ACR90 responses , respectively .
RESULTS	Rates/100 patient-years ( PY ) of adverse events ( AEs ) and serious AEs ( SAEs ) were 480 and 12.5 , respectively ; infections were the most common SAE ( 4.9 / 100 PY ) .
CONCLUSIONS	Tocilizumab treatment results in significant improvement , maintained over time , of pcJIA signs and symptoms and has a safety profile consistent with that for adults with rheumatoid arthritis .
BACKGROUND	NCT00988221 .

###25867814
BACKGROUND	Postprandial triglyceride ( TG ) concentration is independently associated with cardiovascular disease risk .
BACKGROUND	Exercise reduces postprandial TG concentrations , but the mechanisms responsible are unclear .
OBJECTIVE	The objective was to determine the effects of exercise on affinity of chylomicrons , large very low-density lipoproteins ( VLDL1 ) , and smaller VLDL ( VLDL2 ) for lipoprotein lipase ( LPL ) - mediated TG hydrolysis .
METHODS	This was designed as a within-participant crossover study .
METHODS	The setting was a university metabolic investigation unit .
METHODS	Participants were 10 overweight/obese men .
METHODS	Participants undertook two oral fat tolerance tests , separated by 7-14 days , in which they had blood taken while fasting and for 4 hours after a high-fat mixed meal .
METHODS	On the afternoon before one test , they performed a 90-minute treadmill walk at 50 % maximal oxygen uptake ( exercise trial [ EX ] ) ; no exercise was performed before the control trial ( CON ) .
METHODS	We measured circulating TG-rich lipoprotein concentrations and affinity of chylomicrons , VLDL1 , and VLDL2 for LPL-mediated TG hydrolysis .
RESULTS	Exercise significantly reduced fasting VLDL1-TG concentration ( CON , 0.49 [ 0.33-0 .72 ] mmol.L ( -1 ) ; EX , 0.36 [ 0.22-0 .59 ] mmol.L ( -1 ) ; geometric means [ 95 % confidence interval ] ; P = .04 ) .
RESULTS	Time-averaged postprandial chylomicron-TG ( CON , 0.55 0.10 mmol.L ( -1 ) ; EX , 0.39 0.08 mmol.L ( -1 ) ; mean SEM ; P = .03 ) and VLDL1-TG ( CON , 0.85 0.13 mmol.L ( -1 ) ; EX , 0.66 0.10 mmol.L ( -1 ) ; P = .01 ) concentrations were both lower in EX than CON .
RESULTS	Affinity of VLDL1 for LPL-mediated TG hydrolysis increased by 2.2 ( 1.3-3 .7 ) - fold [ geometric mean ( 95 % confidence interval ) ] ( P = .02 ) in the fasted state and 2.6 ( 1.8-2 .6 ) - fold ( P = .001 ) postprandially .
RESULTS	Affinity of chylomicrons and VLDL2 was not significantly different between trials .
CONCLUSIONS	Exercise increases affinity of VLDL1 for LPL-mediated TG hydrolysis both fasting and postprandially .
CONCLUSIONS	This mechanism is likely to contribute to the TG-lowering effect of exercise .

###25516481
BACKGROUND	Moxibustion is one of the most commonly used therapies in acupuncture practice , and is demonstrated to be beneficial for patients with diarrhea from irritable bowel syndrome ( D-IBS ) .
BACKGROUND	But its mechanism remains unclear .
BACKGROUND	Because visceral hypersensitivity in IBS patients has been documented by evaluation of perceived stimulations through functional magnetic resonance imaging ( fMRI ) studies , we focused on observing brain imaging changes in D-IBS patients during rectal balloon distention before and after moxibustion in order to reveal its possible central mechanism and further evaluate its effect .
METHODS	This clinical trial is registered under the number : ChiCTR-TRC-10000887 .
METHODS	Eighty D-IBS patients were randomly divided into a moxibustion and sham moxibustion group ( control group ) for a 4-week treatment .
METHODS	Fifteen patients in moxibustion group and thirteen patients in control group completed two fMRI scans during a 50 and 100ml rectal balloon distention before and after treatment .
METHODS	Rectal pain were obtained with a scan test .
METHODS	Birmingham IBS Symptom Scale and IBS Quality of Life ( QOL ) Scale were used to evaluate therapeutic effect .
RESULTS	After treatment , the decrease in Birmingham IBS Symptom Scale and IBS QOL Scale scores in moxibustion group was significantly greater than that of control group ( P < 0.01 ) .
RESULTS	The defecation urge threshold and the pain perception threshold of moxibustion group was also significantly higher after treatment than that of control group ( P < 0.01 ) .
RESULTS	The decrease in pain score during the 100ml rectal balloon distention in moxibustion group was significantly greater than that of control group ( P < 0.05 ) .
RESULTS	There was no definite activated center during the 50ml rectal distention in either group before treatment .
RESULTS	After treatment , the prefrontal cortex ( PFC ) was affected in moxibustion group , while the PFC and the anterior cingulated cortex ( ACC ) were affected in control group .
RESULTS	During the 100ml distention before treatment in both groups , the PFC and ACC were activated .
RESULTS	After treatment , they disappeared in moxibustion group but remained in control group .
CONCLUSIONS	Moxibustion can improve symptoms and quality of life in D-IBS patients .
CONCLUSIONS	It can also decrease rectal sensitivity .
CONCLUSIONS	The activation of PFC and ACC during a 100ml rectal distention disappeared after moxibustion treatment .

###25428655
BACKGROUND	Most dental procedures require a dry working environment .
BACKGROUND	Although many evaporative drying methods are available , an additional reduction of salivary flow would often be helpful .
METHODS	This prospective randomized cross-over study compares salivary production in 31 volunteers during direct , indirect , and non-suggestive ( control group ) intervention .
METHODS	Overall , each volunteer underwent four salivation measurements , i.e. two measurements during two different types of hypnotic suggestion ( indirect and direct ) arranged in random order and two control sections .
METHODS	All four measurements were conducted successively .
RESULTS	Both suggestive methods significantly reduced salivary production in comparison to the two control sections ( direct suggestion = 1.46 grams per 5 min , p < 0.001 , indirect suggestion = 0.94 grams per 5 min , p = 0.039 ) .
RESULTS	Direct suggestion showed a significantly higher reduction of salivary production than indirect suggestion ( = -0.53 grams per 5 min , p = 0.001 ) .
CONCLUSIONS	Hypnotic suggestion represents a simple and inexpensive method to reduce salivation and could thus create a better working environment for more comfortable dental treatments for both patients and dentists .

###25549086
BACKGROUND	Artemisinin combination therapies ( ACTs ) with broad efficacy are needed where multiple Plasmodium species are transmitted , especially in children , who bear the brunt of infection in endemic areas .
BACKGROUND	In Papua New Guinea ( PNG ) , artemether-lumefantrine is the first-line treatment for uncomplicated malaria , but it has limited efficacy against P. vivax .
BACKGROUND	Artemisinin-naphthoquine should have greater activity in vivax malaria because the elimination of naphthoquine is slower than that of lumefantrine .
BACKGROUND	In this study , the efficacy , tolerability , and safety of these ACTs were assessed in PNG children aged 0.5-5 y.
RESULTS	An open-label , randomized , parallel-group trial of artemether-lumefantrine ( six doses over 3 d ) and artemisinin-naphthoquine ( three daily doses ) was conducted between 28 March 2011 and 22 April 2013 .
RESULTS	Parasitologic outcomes were assessed without knowledge of treatment allocation .
RESULTS	Primary endpoints were the 42-d P. falciparum PCR-corrected adequate clinical and parasitologic response ( ACPR ) and the P. vivax PCR-uncorrected 42-d ACPR .
RESULTS	Non-inferiority and superiority designs were used for falciparum and vivax malaria , respectively .
RESULTS	Because the artemisinin-naphthoquine regimen involved three doses rather than the manufacturer-specified single dose , the first 188 children underwent detailed safety monitoring .
RESULTS	Of 2,542 febrile children screened , 267 were randomized , and 186 with falciparum and 47 with vivax malaria completed the 42-d follow-up .
RESULTS	Both ACTs were safe and well tolerated .
RESULTS	P. falciparum ACPRs were 97.8 % and 100.0 % in artemether-lumefantrine and artemisinin-naphthoquine-treated patients , respectively ( difference 2.2 % [ 95 % CI -3.0 % to 8.4 % ] versus -5.0 % non-inferiority margin , p = 0.24 ) , and P. vivax ACPRs were 30.0 % and 100.0 % , respectively ( difference 70.0 % [ 95 % CI 40.9 % -87.2 % ] , p < 0.001 ) .
RESULTS	Limitations included the exclusion of 11 % of randomized patients with sub-threshold parasitemias on confirmatory microscopy and direct observation of only morning artemether-lumefantrine dosing .
CONCLUSIONS	Artemisinin-naphthoquine is non-inferior to artemether-lumefantrine in PNG children with falciparum malaria but has greater efficacy against vivax malaria , findings with implications in similar geo-epidemiologic settings within and beyond Oceania .
BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12610000913077 .
BACKGROUND	Please see later in the article for the Editors ' Summary .

###25286691
OBJECTIVE	To investigate the safety and maximum tolerable dosage of injectable cefetamet sodium Sixty healthy volunteers were enrolled in this study .
OBJECTIVE	with a single infusion in Chinese healthy volunteers .
METHODS	A double-blinded , randomized , placebo-controlled design was adopted .
METHODS	Eight dosages ranging from 100 mg to 5 000 mg were tested .
METHODS	The pharmacokinetics of the drug was analyzed using a Latin square three-cross self-controlled design , with 12 healthy volunteers receiving 500 mg , 1 000 mg and 2 000 mg of injectable cefetamet sodium in a randomized sequence .
METHODS	Blood and urine samples were collected and analyzed using high performance liquid chromatography with UV detection .
METHODS	The main pharmacokinetics parameters were calculated with DAS2 .0 software .
RESULTS	59 healthy volunteers completed the tolerance tests .
RESULTS	Clinical adverse reactions occurred in 22.73 % of participants in the test group and 6.67 % of participants in the placebo group ; but the difference was not statistically significant .
RESULTS	Common adverse events included infusion pain and dizziness .
RESULTS	Rare adverse events such as palpitations , diarrhea and rash occurred in participants in the test group .
RESULTS	All of the adverse reactions were mild .
RESULTS	Abnormal laboratory test results occurred in 43.18 % participants in the test group and 53.33 % participants in the placebo group ; again the difference was not statistically significant .
RESULTS	Common abnormal laboratory test results included abnormal bowel flora , stool abnormalities , abnormal urine and elevated serum potassium .
RESULTS	After a single infusion of 500 mg , 1 000 mg and 2 000 mg of injectable cefetamet sodium , peak concentration of the drug at 0.5 h reached ( 37.92 + / - 7.43 ) , ( 74.90 + / - 10.67 ) and ( 148.54 + / - 31.63 ) mg/L , with areas under concentration-time curve of ( 72.08 + / - 14.98 ) , ( 144.28 + / - 24.57 ) and ( 286.66 + / - 54.25 ) ( mg x h ) / L , respectively .
RESULTS	Their elimination half-life was ( 2.03 + / - 0.38 ) , ( 2.04 + / - 0.26 ) , and ( 2.12 + / - 0.26 ) h , respectively .
RESULTS	The disposition of cefetamet was presented as a two-compartment model with linear kinetics .
RESULTS	The 24-hour urinary accumulation excretion was 76.6 % -67.5 % .
CONCLUSIONS	The maximum single tolerated dose of injectable cefetamet sodium is 5 000 mg .
CONCLUSIONS	The pharmacokinetics is a two-compartment model with linear kinetics within a dose range 500-2 000 mg .

###24429127
BACKGROUND	Whether the combination of a once-daily inhaled corticosteroid with a once-daily longacting ( 2 ) agonist is more protective than a once-daily longacting ( 2 ) agonist alone against exacerbations of chronic obstructive pulmonary disease ( COPD ) is unknown .
BACKGROUND	We hypothesised that fluticasone furoate and vilanterol would prevent more exacerbations than would vilanterol alone .
METHODS	We did two replicate double-blind parallel-group 1 year trials .
METHODS	Both studies began on Sept 25 , 2009 .
METHODS	Study 1 ended on Oct 31 , 2011 , and study 2 on Oct 17 , 2011 .
METHODS	Eligible patients were aged 40 years or older , had a history of COPD , a smoking history of 10 or more pack-years , a ratio of forced expiratory volume in 1 s ( FEV ( 1 ) ) to forced vital capacity of 070 or less after bronchodilators ( and an FEV ( 1 ) of 70 % or less of predicted ) , and a documented history of one or more moderate or severe disease exacerbations in the year before screening .
METHODS	Patients were randomly assigned ( 1:1:1:1 ) on the basis of the Registration and Medication Ordering System to 25 g vilanterol alone or 25 g vilanterol combined with either 50 g , 100 g , or 200 g fluticasone furoate once daily .
METHODS	Our primary endpoint was the yearly rate of moderate and severe exacerbations .
METHODS	The trials were analysed separately and a pooled analysis was also done .
METHODS	These trials are registered with ClinicalTrials.gov ( NCT01009463 and NCT01017952 ) .
RESULTS	1622 patients in study 1 and 1633 patients in study 2 were randomly assigned .
RESULTS	In study 1 , no significant difference in exacerbation rate was noted between the 200/25 g fluticasone furoate/vilanterol group and the vilanterol only group ( mean 090 events vs 105 events per year ; ratio 09 [ 95 % CI 07-10 ] ) .
RESULTS	Because of the statistical hierarchy used , we could not infer significance for the 50 g and 100 g groups .
RESULTS	In study 2 , significantly fewer moderate and severe exacerbations were noted in all fluticasone furoate/vilanterol groups than in the vilanterol only group ( p = 00398 for the 50 g group , 00244 for the 100 g group , and 00004 for the 200 g group ) .
RESULTS	In the pooled analysis , significantly fewer moderate and severe exacerbations were noted in all fluticasone furoate/vilanterol groups than in the vilanterol only group ( 00141 for the 50 g group , < 00001 for the 100 g group , and 00003 for the 200 g group ) .
RESULTS	Nasopharyngitis was the most frequently reported adverse event in both studies .
RESULTS	Pneumonia and fractures were reported more frequently with fluticasone furoate and vilanterol than with vilanterol alone .
RESULTS	Eight deaths from pneumonia were noted in the fluticasone furoate/vilanterol groups compared with none in the vilanterol only group .
CONCLUSIONS	Addition of fluticasone furoate to vilanterol was associated with a decreased rate of moderate and severe exacerbations of COPD in patients with a history of exacerbation , but was also associated with an increased pneumonia risk .
BACKGROUND	GlaxoSmithKline .

###25539330
BACKGROUND	Recent literature has focused on the advantages and disadvantages of using acellular dermal matrix in breast reconstruction .
BACKGROUND	Many of the reported data are from low level-of-evidence studies , leaving many questions incompletely answered .
BACKGROUND	The present randomized trial provides high-level data on the incidence and severity of complications in acellular dermal matrix breast reconstruction between two commonly used types of acellular dermal matrix .
METHODS	A prospective randomized trial was conducted to compare outcomes of immediate staged tissue expander breast reconstruction using either AlloDerm or DermaMatrix .
METHODS	The impact of body mass index , smoking , diabetes , mastectomy type , radiation therapy , and chemotherapy on outcomes was analyzed .
METHODS	Acellular dermal matrix biointegration was analyzed clinically and histologically .
METHODS	Patient satisfaction was assessed by means of preoperative and postoperative surveys .
METHODS	Logistic regression models were used to identify predictors of complications .
RESULTS	This article reports on the study design , surgical technique , patient characteristics , and preoperative survey results , with outcomes data in a separate report .
RESULTS	After 2.5 years , we successfully enrolled and randomized 128 patients ( 199 breasts ) .
RESULTS	The majority of patients were healthy nonsmokers , with 41 percent of patients receiving radiation therapy and 49 percent receiving chemotherapy .
RESULTS	Half of the mastectomies were prophylactic , with nipple-sparing mastectomy common in both cancer and prophylactic cases .
RESULTS	Preoperative survey results indicate that patients were satisfied with their premastectomy breast reconstruction education .
CONCLUSIONS	Results from the Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial will assist plastic surgeons in making evidence-based decisions regarding acellular dermal matrix-assisted tissue expander breast reconstruction .
METHODS	Therapeutic , II .

###25524969
OBJECTIVE	To investigate the effect of whey protein plus potassium bicarbonate supplement on disused skeletal muscle structure and proteolysis after bed rest ( BR ) .
METHODS	Soleus ( SOL ) and vastus lateralis ( VL ) biopsies were sampled from ten ( n = 10 ) healthy male subjects ( aged 316 years ) who did BR once with and once without protein supplement as a dietary countermeasure ( cross-over study design ) .
METHODS	The structural changes ( myofibre size and type distribution ) were analysed by histological sections , and muscle protein breakdown indirectly via the proteolysis markers , calpain 1 and 3 , calpastatin , MuRF1 and 2 , both in muscle homogenates and by immunohistochemistry .
RESULTS	BR caused size-changes in myofiber cross-sectional area ( FCSA , SOL , p = 0,004 ; VL , p = 0.03 ) , and myofiber slow-to-fast type transition with increased hybrids ( SOL , p = 0.043 ; VL , p = 0.037 ) however with campaign differences in SOL ( p < 0.033 ) .
RESULTS	No significant effect of BR and supplement was found by any of the key proteolysis markers .
CONCLUSIONS	Campaign differences in structural muscle adaptation may be an issue in cross-over design BR studies .
CONCLUSIONS	The whey protein plus potassium bicarbonate supplement did not attenuate atrophy and fibre type transition during medium term bed rest .
CONCLUSIONS	Alkaline whey protein supplements may however be beneficial as adjuncts to exercise countermeasures in disuse .

###25768238
OBJECTIVE	Visceral and shoulder tip pain following laparoscopic cholecystectomy is mainly due to carbon dioxide ( CO2 ) insufflation .
OBJECTIVE	Various methods have been adopted to eliminate residual CO2 .
OBJECTIVE	We compared the postoperative analgesic efficacy of intraperitoneal normal saline ( 30mL/kg ) irrigation with preoperative oral acetazolamide administration in patients undergoing laparoscopic cholecystectomy .
METHODS	Sixty patients between 20 and 60 years of age were included in this prospective , randomized , double-blind study .
METHODS	Patients in Group I received placebo , Group II patients received preoperative oral acetazolamide ( 5mg/kg ) , and Group III patients received intraperitoneal irrigation with 30mL/kg of normal saline .
METHODS	Intravenous paracetamol ( 1g ) was administered every 6 hours for postoperative analgesia .
METHODS	Parietal and visceral pain scores at rest , on movement , and on coughing and shoulder tip pain were recorded using a visual analog scale after arrival in the postanesthesia care unit , at 1 , 2 , 4 , 6 , 12 , and 24 hours after surgery .
METHODS	Rescue analgesia was provided with an intravenous fentanyl ( 1g/kg ) bolus whenever the visual analog scale score was 4 .
RESULTS	Compared with Group I , Group III patients had significantly lower visceral pain scores at all time intervals except at 12 hours .
RESULTS	Group III patients also recorded significantly lower visceral pain scores than Group II from 2 to 24 hours .
RESULTS	There was no significant difference in shoulder tip pain .
RESULTS	The total dose of fentanyl used was significantly less in Group III .
CONCLUSIONS	Intraperitoneal normal saline irrigation is more effective than acetazolamide in reducing postoperative visceral pain after laparoscopic cholecystectomy and has significant opioid-sparing effect .
CONCLUSIONS	However , its effect on shoulder pain is comparable to that of acetazolamide .

###25127539
BACKGROUND	Several hospitals in Norway provide short self-referral inpatient treatment to patients with severe mental diagnosis .
BACKGROUND	No studies have compared the experiences of patients who have had the opportunity to self-refer to inpatient treatment with patients who have received treatment as usual .
BACKGROUND	This qualitative study was nested within a randomised controlled trial investigating the effect of self-referral to inpatient treatment .
BACKGROUND	The aim was to explore how patients with severe mental diagnosis coped four months after signing a contract for self-referral , as compared to patients receiving treatment as usual .
METHODS	Data was collected using qualitative individual interviews with patients with severe mental diagnosis , conducted four months after being randomised either to a contract for self-referral ( intervention group ) or to treatment as usual ( control group ) .
RESULTS	Twenty-five patients participated in interviews - 11 from the intervention group and 14 from the control group .
RESULTS	Results four months after randomisation showed that patients with a contract for self-referral appeared to have more confidence in strategies to cope with mental illness and to apply more active cognitive strategies .
RESULTS	Patients with a contract also expressed less resignation , hopelessness and powerlessness than patients without a contract .
RESULTS	In addition , patients with a contract seemed to be closer to the ideal of living a `` normal '' life and being a `` normal '' person .
CONCLUSIONS	The results indicate that the patients who had a contract for self-referral had come further in the recovery process and should possibly be better off during treatment .

###25040756
BACKGROUND	Tramadol is used following neonatal cardiac and general surgery .
BACKGROUND	However , its ability to opioid-spare or facilitate earlier extubation in postoperative neonates is unquantified .
OBJECTIVE	This randomized placebo-controlled trial aimed to assess whether tramadol 's addition to standard analgesia resulted in earlier extubation or reduced analgesic/sedative requirements in postsurgical neonates .
METHODS	Neonates born 32 weeks postmenstrual age received either tramadol [ T ] 2 mgkg ( -1 ) or placebo [ P ] 6-hourly for up to 5 days postthoracoabdominal surgery in addition to morphine ( commenced at 20 mcgkg ( -1 ) h ( -1 ) ) and 6-hourly i.v. acetaminophen .
METHODS	Time to extubation , morphine and midazolam amounts , hourly pain scores , and seizure activity were compared using an intention-to-treat and per-protocol analysis .
RESULTS	Seventy-one neonates participated .
RESULTS	Median survival time to extubation was similar between the groups ( T 67 h [ 95 % CI 51 , 84 ] vs P 52 h [ 95 % CI 43 , 65 ] ; P = 0.4 ) , and similar numbers were extubated by 96 h ( T 69 % vs P 77 % ; difference -8 % , 95 % CI -28 , 13 % ) .
RESULTS	Morphine and midazolam exposure was similar , with low pain scores in both groups ( mean percentage of time with a pain score > 5/20 during the 5 days : T 13 % vs P 11 % , difference in means 2.8 [ 95 % CI -1.8 , 7.6 ] , P = 0.20 ) .
RESULTS	Most participants had normal cranial ultrasounds ( T 86 % vs P 86 % ) ; no seizures occurred clinically or electroencephalographically .
CONCLUSIONS	Tramadol 's addition to standard analgesia in this small group of postsurgical neonates did not appear to have any positive effect on time to extubation , morphine or midazolam exposure , or pain scores .
CONCLUSIONS	This questions the benefit of tramadol for postsurgical neonates .
CONCLUSIONS	Importantly , no seizures occurred in these ill neonates who may potentially be at greater risk of tramadol toxicity compared with adults .

###24273967
OBJECTIVE	To assess the efficacy and safety of three different Chinese medical principles in treating patients with male infertility ( oligospermia/asthenozoospermia ) .
METHODS	Totally 128 patients with male infertility were classified into 3 groups , i.e. , Shen-essence deficiency syndrome , Pi-Shen deficiency syndrome , Shen-deficiency blood-stasis syndrome .
METHODS	They were assigned to the Chinese medical treatment group ( 96 cases ) and the Western medical treatment group ( 32 cases ) by stratified randomization in the ratio of 3 : 1 .
METHODS	Those in the Chinese medical treatment group were treated with Chinese drugs for Shen invigorating and blood activating , Shen invigorating and Pi supplementing , Shen-qi benefiting .
METHODS	Those in the Western medical treatment group were treated with Clomifene ( at the daily dose of 25 mg per day , once daily ) .
METHODS	Three months consisted of one therapeutic course .
METHODS	The parameters of semen , the pregnancy rate , and adverse reactions were observed .
RESULTS	Totally 24 patients dropped out in the two group , 17 in the Chinese medical treatment group ( 9 patients of Shen deficiency blood stasis syndrome , 5 of Shen-Pi deficiency syndrome , and 3 of Shen-essence deficiency syndrome ) and 7 in the Western medical treatment group .
RESULTS	Compared with before treatment , there was no statistical difference in the improvement of semen amount at 3 months after treatment between the two groups ( P > 0.05 ) .
RESULTS	There was statistical difference in the improvement of semen density , class A semen , class A + B semen , and 1-h activity ratio ( P < 0.05 ) .
RESULTS	The improvement was most obvious in Shen deficiency blood stasis syndrome , followed by Shen-Pi deficiency syndrome and Shen-essence deficiency syndrome .
RESULTS	The improvement was the weakest in the Western medical treatment group .
RESULTS	There was no statistical difference in the improvement of semen amount , semen density , class A semen , or 1-h activity ratio at 3 months after treatment between the two groups ( P > 0.05 ) .
RESULTS	Best effect was obtained in improving class A + B semen quality in patients of Shen deficiency blood stasis syndrome , showing statistical difference when compared with the other two syndrome types and the Western medical treatment group ( P < 0.05 , P < 0.01 ) .
RESULTS	No obvious adverse reaction occurred in the two groups during the treatment course .
CONCLUSIONS	Shen invigorating and blood activating method could improve the semen density and semen activities , and it was superior to other therapeutic methods .

###25004353
OBJECTIVE	To estimate the association of obesity and extreme obesity with maternal complications after cesarean delivery .
METHODS	This was a secondary cohort analysis of a randomized controlled trial .
METHODS	The parent study was designed to estimate the effect of supplemental oxygen on postcesarean infectious morbidity .
METHODS	Because the study intervention had no effect , study groups were combined as a cohort .
METHODS	For this secondary analysis , the exposure was obesity , stratified as normal or overweight ( body mass index [ BMI ] less than 30 ) , obese ( BMI 30-45 ) , or extremely obese ( BMI higher than 45 ) .
METHODS	The primary outcome was a composite of wound infection and endometritis .
METHODS	Secondary outcomes included wound infection , endometritis , wound opening , hematoma or seroma , and emergency department visit .
METHODS	We performed unadjusted and multivariable logistic regression analyses .
METHODS	Adjusted odds ratios ( ORs ) and 95 % confidence intervals ( CIs ) are reported .
RESULTS	We included 585 women in the analysis .
RESULTS	Eighty-five patients ( 14.5 % ) had BMIs higher than 45 .
RESULTS	Rates of black race , chronic hypertension , diabetes , and gestational diabetes increased and operative duration increased with increasing obesity severity .
RESULTS	Obese patients were more likely to have a cesarean delivery after labor and have a vertical skin incision or classical uterine incision .
RESULTS	After controlling for confounders , extremely obese patients had a twofold to fourfold increase in postoperative complications , including the primary infectious outcome ( 18.8 % , adjusted OR 2.7 , CI 1.2-6 .1 ) , wound infection ( 18.8 % , adjusted OR 3.4 , CI 1.4-8 .0 ) , and emergency department visit ( 23.1 % , adjusted OR 2.2 , CI 1.03-4 .9 ) .
CONCLUSIONS	Maternal extreme obesity is associated with a considerable increase in postcesarean wound complications .
BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT00602603 .
METHODS	II .

###24456716
OBJECTIVE	This study sought to evaluate the safety and efficacy of the Lutonix drug-coated balloon ( DCB ) coated with 2 g/mm ( 2 ) paclitaxel and a polysorbate/sorbitol carrier for treatment of femoropopliteal lesions .
BACKGROUND	Percutaneous treatment of peripheral vascular disease is associated with a high recurrence .
BACKGROUND	Paclitaxel-coated balloons at 3 g/mm ( 2 ) formulated differently have shown promising results with reduced restenosis .
BACKGROUND	Methods Subjects at 9 centers with Rutherford class 2 to 5 femoropopliteal lesions were randomized between June 2009 and December 2009 to treatment with Lutonix DCB ( n = 49 ) versus uncoated balloons ( control group [ n = 52 ] ) , stratified by whether balloon-only treatment ( n = 75 ) or stenting ( n = 26 ) was intended .
BACKGROUND	The primary endpoint was angiographic late lumen loss at 6 months .
BACKGROUND	Secondary outcomes included adjudicated major adverse events ( death , amputation , target lesion thrombosis , reintervention ) , functional outcomes , and pharmacokinetics .
RESULTS	Demographic , peripheral vascular disease , and lesion characteristics were matched , with mean lesion length of 8.1 3.8 cm and 42 % total occlusions .
RESULTS	At 6 months , late lumen loss was 58 % lower for the Lutonix DCB group ( 0.46 1.13 mm ) than for the control group ( 1.09 1.07 mm ; p = 0.016 ) .
RESULTS	Composite 24-month major adverse events were 39 % for the DCB group , including 15 target lesion revascularizations , 1 amputation , and 4 deaths versus 46 % for uncoated balloon group , with 20 target lesion revascularizations , 1 thrombosis , and 5 deaths .
RESULTS	Pharmacokinetics showed biexponential decay with peak concentration ( Cmax ) of 59 ng/ml and total observed exposure ( AUC ( all ) ) of 73 ng h/ml .
RESULTS	For successful DCB deployment excluding 8 malfunctions , 6-month late lumen loss was 0.39 mm and the 24-month target lesion revascularization rate was 24 % .
CONCLUSIONS	Treatment of femoropopliteal lesions with the low-dose Lutonix DCB reduced late lumen loss with safety comparable to that of control angioplasty .
CONCLUSIONS	( LEVANT I , The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis ; NCT00930813 )

###25005331
OBJECTIVE	Since protein ingestion is known to stimulate the secretion of glucagon-like peptide-1 ( GLP-1 ) , we hypothesised that enhancing GLP-1 secretion to harness its insulinotropic/beta cell-stimulating activity with whey protein pre-load may have beneficial glucose-lowering effects in type 2 diabetes .
METHODS	In a randomised , open-label crossover clinical trial , we studied 15 individuals with well-controlled type 2 diabetes who were not taking any medications except for sulfonylurea or metformin .
METHODS	These participants consumed , on two separate days , 50 g whey in 250 ml water or placebo ( 250 ml water ) followed by a standardised high-glycaemic-index breakfast in a hospital setting .
METHODS	Participants were randomised using a coin flip .
METHODS	The primary endpoints of the study were plasma concentrations of glucose , intact GLP-1 and insulin during the 30 min following meal ingestion .
RESULTS	In each group , 15 patients were analysed .
RESULTS	The results showed that over the whole 180 min post-meal period , glucose levels were reduced by 28 % after whey pre-load with a uniform reduction during both early and late phases .
RESULTS	Insulin and C-peptide responses were both significantly higher ( by 105 % and 43 % , respectively ) with whey pre-load .
RESULTS	Notably , the early insulin response was 96 % higher after whey .
RESULTS	Similarly , both total GLP-1 ( tGLP-1 ) and intact GLP-1 ( iGLP-1 ) levels were significantly higher ( by 141 % and 298 % , respectively ) with whey pre-load .
RESULTS	Dipeptidyl peptidase 4 plasma activity did not display any significant difference after breakfast between the groups .
CONCLUSIONS	In summary , consumption of whey protein shortly before a high-glycaemic-index breakfast increased the early prandial and late insulin secretion , augmented tGLP-1 and iGLP-1 responses and reduced postprandial glycaemia in type 2 diabetic patients .
CONCLUSIONS	Whey protein may therefore represent a novel approach for enhancing glucose-lowering strategies in type 2 diabetes .
CONCLUSIONS	Trial registration ClinicalTrials.gov NCT01571622 Funding The Israeli Ministry of Health and Milk Council funded the research .

###24625922
OBJECTIVE	To determine if indomethacin has a positive clinical effect for the prophylaxis of heterotopic ossification ( HO ) after acetabular fracture surgery .
OBJECTIVE	To determine whether indomethacin affects the union rate of acetabular fractures .
METHODS	Prospective randomized double-blinded trial .
METHODS	Level 1 regional trauma center .
METHODS	Skeletally mature patients treated operatively for an acute acetabular fracture through a Kocher-Langenbeck approach .
METHODS	Patients were randomly allocated to 1 of 4 groups comparing placebo ( group 1 ) to 3 days ( group 2 ) , 1 week ( group 3 ) , and 6 weeks ( group 4 ) of indomethacin treatment .
METHODS	Factors analyzed included the overall incidence , Brooker class and volume of HO , radiographic union of the acetabular fracture , and pain .
METHODS	Patients were followed clinically and radiographically at 6 weeks , 3 months , 6 months , and 1 year .
METHODS	Serum levels of indomethacin were drawn at 1 month to assess compliance .
METHODS	Computed tomographic scans were performed at 6 months to assess healing and volume of HO .
RESULTS	Ninety-eight patients were enrolled into this study , 68 completed the follow-up and had the 6-month computed tomographic scan , and there was a 63 % compliance rate with the treatment regimen .
RESULTS	Overall incidence of HO was 67 % for group 1 , 29 % for group 2 ( P = 0.04 ) , 29 % for group 3 ( P = 0.019 ) , and 67 % for group 4 .
RESULTS	The volume of HO formation was 17,900 mm for group 1 , 33,800 mm for group 2 , 6300 mm for group 3 ( P = 0.005 ) , and 11,100 mm for group 4 .
RESULTS	The incidence of radiographic nonunion was 19 % for group 1 , 35 % for group 2 , 24 % for group 3 , and 62 % for group 4 ( P = 0.012 ) .
RESULTS	Seventy-seven percent of the nonunions involved the posterior wall segment .
RESULTS	Pain visual analog scores ( VASs ) were significantly higher for patients with radiographic nonunion ( VAS 4 vs. VAS 1 , P = 0.002 ) .
CONCLUSIONS	Treatment with 6 weeks of indomethacin does not appear to have a therapeutic effect for decreasing HO formation after acetabular fracture surgery and appears to increase the incidence of nonunion .
CONCLUSIONS	Treatment with 1 week of indomethacin may be beneficial for decreasing the volume of HO formation without increasing the incidence of nonunion .
METHODS	Therapeutic Level II .
METHODS	See Instructions for Authors for a complete description of levels of evidence .

###24379581
OBJECTIVE	To compare efficacy and complications of partially covered self-expandable metal stent ( pcSEMS ) to plastic stent ( PS ) in patients treated for malignant , infrahilar biliary obstruction .
METHODS	Multicenter prospective randomized clinical trial with treatment allocation to a pcWallstent ( ) ( SEMS ) or a 10 French PS .
METHODS	Palliative patients aged 18 , for infrahilar malignant biliary obstruction and a Karnofsky performance scale index > 60 % from 6 participating North American university centers .
METHODS	Primary endpoint was time to stent failure , with secondary outcomes of death , adverse events , Karnofsky performance score and short-form-36 scale administered on a three-monthly basis for up to 2 years .
METHODS	Survival analyses were performed for stent failure and death , with Cox proportional hazards regression models to determine significant predictive characteristics .
RESULTS	Eighty-five patients were accrued over 37 mo , 42 were randomized to the SEMS group and 83 patients were available for analyses .
RESULTS	Time to stent failure was 385.3 52.5 d in the SEMS and 153.3 19.8 d in the PS group , P = 0.006 .
RESULTS	Time to death did not differ between groups ( 192.3 23.4 d for SEMS vs 211.5 28.0 d for PS , P = 0.70 ) .
RESULTS	The only significant predictor was treatment allocation , relating to the time to stent failure ( P = 0.01 ) .
RESULTS	Amongst other measured outcomes , only cholangitis differed , being more common in the PS group ( 4.9 % vs 24.5 % , P = 0.029 ) .
RESULTS	The small number of patients in follow-up limits longitudinal assessments of performance and quality of life .
RESULTS	From an initially planned 120 patients , only 85 patients were recruited .
CONCLUSIONS	Partially covered SEMS result in a longer duration till stent failure without increased complication rates , yet without accompanying measurable benefits in survival , performance , or quality of life .

###25096386
BACKGROUND	In this 2-site randomized trial , we investigated the effect of antiseptic drain care on bacterial colonization of surgical drains and infection after immediate prosthetic breast reconstruction .
METHODS	With IRB approval , we randomized patients undergoing bilateral mastectomy and reconstruction to drain antisepsis ( treatment ) for one side , with standard drain care ( control ) for the other .
METHODS	Antisepsis care included both : chlorhexidine disc dressing at drain exit site ( s ) and irrigation of drain bulbs twice daily with dilute sodium hypochlorite solution .
METHODS	Cultures were obtained from bulb fluid at 1 week and at drain removal , and from the subcutaneous drain tubing at removal .
METHODS	Positive cultures were defined as 1 + growth for fluid and > 50 CFU for tubing .
RESULTS	Cultures of drain bulb fluid at 1 week ( the primary endpoint ) were positive in 9.9 % of treatment sides ( 10 of 101 ) versus 20.8 % ( 21 of 101 ) of control sides ( p = 0.02 ) .
RESULTS	Drain tubing cultures were positive in 0 treated drains versus 6.2 % ( 6 of 97 ) of control drains ( p = 0.03 ) .
RESULTS	Surgical site infection occurred within 30 days in 0 antisepsis sides versus 3.8 % ( 4 of 104 ) of control sides ( p = 0.13 ) , and within 1 year in three of 104 ( 2.9 % ) of antisepsis sides versus 6 of 104 ( 5.8 % ) of control sides ( p = 0.45 ) .
RESULTS	Clinical infection occurred within 1 year in 9.7 % ( 6 of 62 ) of colonized sides ( tubing or fluid ) versus 1.5 % ( 2 of 136 ) of noncolonized sides ( p = 0.03 ) .
CONCLUSIONS	Simple and inexpensive local antiseptic interventions with a chlorhexidine disc and hypochlorite solution reduce bacterial colonization of drains , and reduced drain colonization was associated with fewer infections .

###24813808
OBJECTIVE	Providing consistent levels of oxygen saturation ( SpO2 ) for infants in neonatal intensive care units is not easy .
OBJECTIVE	This study explored how effectively the Auto-Mixer ( ) algorithm automatically adjusted fraction of inspired oxygen ( FiO2 ) levels to maintain SpO2 within an intended range in extremely low birth weight infants receiving supplemental oxygen without mechanical ventilation .
METHODS	Twenty extremely low birth weight infants were randomly assigned to the Auto-Mixer ( ) group or the manual intervention group and studied for 12h .
METHODS	The SpO2 target was 85-93 % , and the outcomes were the percentage of time SpO2 was within target , SpO2 variability , SpO2 > 95 % , oxygen received and manual interventions .
RESULTS	The percentage of time within intended SpO2 was 584 % in the Auto-Mixer ( ) group and 33.74.7 % in the manual group , SpO2 > 95 % was 26.5 % vs 54.8 % , average SpO2 and FiO2 were 89.8 % vs 92.2 % and 37 % vs 44.1 % , and manual interventions were 0 vs 80 ( p < 0.05 ) .
RESULTS	Brief periods of SpO2 < 85 % occurred more frequently in the Auto-Mixer ( ) group .
CONCLUSIONS	The Auto-Mixer ( ) effectively increased the percentage of time that SpO2 was within the intended target range and decreased the time with high SpO2 in spontaneously breathing extremely low birth weight infants receiving supplemental oxygen .

###24846518
OBJECTIVE	This post hoc analysis examined the effects of adalimumab in patients with scalp and/or nail psoriasis from BELIEVE ( a randomized , controlled , multicentre phase 3 safety and efficacy trial ) .
METHODS	Efficacy was assessed in the pooled treatment group ( adalimumab with or without calcipotriol plus betamethasone dipropionate ) by Psoriasis Area and Severity Index ( 75 % improvement ; PASI 75 ) , Psoriasis Scalp Severity Index ( PSSI ) , Nail Psoriasis Severity Index ( NAPSI ) , Dermatology Life Quality Index ( DLQI ) and a visual analog scale ( VAS ) for pain .
RESULTS	Of the 730 enrolled patients , 663 ( 91.3 % ) , 457 ( 63.1 % ) and 433 ( 60.1 % ) had psoriasis of the scalp , nails , or both , respectively .
RESULTS	Similar proportions of patients with ( 68.2 % ) and without ( 63.5 % ) scalp involvement achieved a PASI 75 response at week 16 [ adjusted odds ratio ( OR ) , 1.34 ; P = 0.320 ] .
RESULTS	PASI 75 response rates were lower in patients with nail psoriasis compared with patients without nail psoriasis at week 8 ( 53.0 % vs. 62.9 % ; OR , 0.68 ; P = 0.019 ) and week 16 ( 65.0 % vs. 73.0 % ; OR , 0.70 ; P = 0.052 ) .
RESULTS	PASI 75 response rates were 66.1 % in patients with scalp and nail involvement and 70.8 % in patients without both scalp and nail involvement at week 16 ( OR , 0.87 ; P = 0.423 ) .
RESULTS	Patients in all scalp and nail subgroups reported improvements in DLQI and VAS pain scores throughout the study .
RESULTS	Patients with scalp psoriasis exhibited large improvements in scalp symptoms demonstrated by a median ( meanSD ) decrease from baseline PSSI at week 16 of 100 % ( 77.296.9 % ) .
RESULTS	Patients with nail psoriasis improved , demonstrated by a median ( meanSD ) decrease from baseline NAPSI at week 16 of 39.5 % ( 9.4164.5 % ) .
CONCLUSIONS	Our results indicate that adalimumab improves overall psoriasis and scalp and nail symptoms in this patient population with scalp psoriasis and/or nail involvement .
CONCLUSIONS	In addition , similar PASI 75 response rates are achieved in patients with and without scalp involvement , whereas patients with nail involvement demonstrate a moderate ( perhaps delayed ) PASI 75 response rate .

###24766973
BACKGROUND	Anticoagulation before , during , and after cardioversion is effective in reducing stroke risk in patients with atrial fibrillation .
OBJECTIVE	The objective of this study is to explore the efficacy and safety of rivaroxaban 20 mg once daily ( 15 mg if creatinine clearance is 30-49 mL/min ) compared with dose-adjusted vitamin K antagonists ( VKAs ; international normalized ratio 2.0-3 .0 ) in patients scheduled for elective cardioversion .
METHODS	This is a prospective , randomized , open-label , parallel group comparison of approximately 1,500 patients from 17 countries with hemodynamically stable nonvalvular atrial fibrillation of > 48 hours or unknown duration .
METHODS	Patients will be randomized 2:1 ( rivaroxaban : VKA ) using 2 cardioversion strategies : the first approach is early cardioversion with the precardioversion anticoagulation goal of 1 to 5 days using rivaroxaban or usual therapy ( heparin + VKA ) .
METHODS	In these patients , transesophageal echocardiography will be encouraged to exclude atrial thrombi .
METHODS	The alternative approach is delayed cardioversion .
METHODS	Rivaroxaban or VKA will be administered for 21 to 56 days before cardioversion .
METHODS	All patients will receive study treatment for 6 weeks postcardioversion .
METHODS	The primary efficacy end point is a composite of all strokes , transient ischemic attacks , noncentral nervous system systemic emboli , myocardial infarctions , and cardiovascular deaths .
METHODS	Each primary end point component will be evaluated separately , and additional composites will be investigated .
METHODS	The principal safety end point is major bleeding .
METHODS	This will be the first prospective study of a novel oral anticoagulant in the setting of cardioversion .
METHODS	It will provide important information regarding the use of rivaroxaban in the periods preceding and after cardioversion in a broad patient population .

###25131843
BACKGROUND	Although the potential benefits of stereoscopic laparoscopy have been recognized for years , the technology has not been adopted because of poor operator tolerance .
BACKGROUND	Passive polarizing projection systems , which have revolutionized three-dimensional ( 3D ) cinema , are now being trialled in surgery .
BACKGROUND	This study was designed to see whether this technology resulted in significant performance benefits for skilled laparoscopists .
METHODS	Four validated laparoscopic skills tasks , each with ten repetitions , were performed by 20 experienced laparoscopic surgeons , in both two-dimensional ( 2D ) and 3D conditions .
METHODS	The primary outcome measure was the performance error rate ; secondary outcome measures were time for task completion , 3D motion tracking ( path length , motion smoothness and grasping frequency ) and workload dimension ratings of the National Aeronautics and Space Administration ( NASA ) Task Load Index .
RESULTS	Surgeons demonstrated a 62 per cent reduction in the median number of errors and a 35 per cent reduction in median performance time when using the passive polarizing 3D display compared with the 2D display .
RESULTS	There was a significant 15 per cent reduction in median instrument path length , an enhancement of median motion smoothness , and a 15 per cent decrease in grasper frequency with the 3D display .
RESULTS	Participants reported significant reductions in subjective workload dimension ratings of the NASA Task Load Index following use of the 3D displays .
CONCLUSIONS	Passive polarizing 3D displays improved both the performance of experienced surgeons in a simulated setting and surgeon perception of the operative field .
CONCLUSIONS	Although it has been argued that the experience of skilled laparoscopic surgeons compensates fully for the loss of stereopsis , this study indicates that this is not the case .
CONCLUSIONS	Surgical relevance The potential benefits of stereoscopic laparoscopy have been known for years , but the technology has not been adopted because of poor operator tolerance .
CONCLUSIONS	The first laparoscopic operation was carried out using a prototype passive polarizing laparoscopic system in 2010 .
CONCLUSIONS	This is new three-dimensional ( 3D ) technology offers a real option for 3D laparoscopic surgery where previous systems have failed .
CONCLUSIONS	This study is the first to have been carried out using this technology .
CONCLUSIONS	It is essential that new technologies are adopted only when there is robust evidence to support their use .
CONCLUSIONS	Currently , there are concerns about the use of robotic technologies and whether advantages exist for patient care .
CONCLUSIONS	If there are advantages , 3D must be playing a significant role .
CONCLUSIONS	If so , perhaps the technology under investigation here offers potential to a greater spectrum of surgeons , as well as being a more affordable option .

###24559810
OBJECTIVE	To identify the effect of some herbal products on insulin resistance .
OBJECTIVE	Regarding the scientific evidences existing about ginger , this research was therefore carried out to identify the effect of ginger supplementation on insulin resistance and glycemic indices in diabetes mellitus .
METHODS	This is a randomized , double-blind , placebo-controlled trial in which 88 participants affected by diabetes were randomly assigned into ginger ( GG ) and placebo ( PG ) groups .
METHODS	The GG received 3 one-gram capsules containing ginger powder whereas the PG received 3 one-gram microcrystalline-containing capsules daily for 8 weeks .
METHODS	HbA1c , fructosamine , fasting blood sugar ( FBS ) , fasting insulin , homeostasis model assessment insulin resistance index ( HOMA-IR ) , - cell function ( % ) , insulin sensitivity ( S % ) and the quantitative insulin sensitivity check index ( QUICKI ) were assessed before and after the intervention .
RESULTS	FBS mean showed a decrease of 10.5 % ( p = 0.003 ) in the GG whereas the mean had an increase of 21 % in the PG ( p = 0.01 ) .
RESULTS	Variation in HbA1c mean was in line with that of FBS .
RESULTS	Statistical difference was found in the two groups before and after the intervention in terms of median of fasting insulin level , S % and HOMA-IR ( P < 0.005 ) .
RESULTS	Moreover QUICKI mean increased significantly in the two groups , the mean difference , however , was significantly higher in the GG .
CONCLUSIONS	The study demonstrated that daily consumption of 3 one-gram capsules of ginger powder for 8 weeks is useful for patients with type 2 diabetes due to FBS and HbA1c reduction and improvement of insulin resistance indices such as QUICKI index .

###25475136
OBJECTIVE	To study the presence of bacterial biofilm on the sinus mucosa of healthy individuals ( controls ) and patients with chronic rhinosinusitis with or without nasal polyposis .
METHODS	An analytical , prospective and observational study was conducted .
METHODS	Tissue samples were obtained from the sinus mucosa .
METHODS	The bacteria were isolated and typified , and the material was examined for biofilm formation using tissue culture plate , Congo red agar detection and tube methods .
RESULTS	A total of 100 cases were analysed for the presence of biofilm .
RESULTS	Bacterial biofilm was present in 26 of 50 disease group cases ( 52 per cent ) and in 4 of 50 control group cases ( 8 per cent ) ( p < 0.01 ) .
CONCLUSIONS	The presence of biofilm on the mucosa of chronic rhinosinusitis patients offers a possible cause for the persistent inflammation , and for antibiotics resistance and antimicrobial therapy failure .
CONCLUSIONS	These findings could change the approach to treatment .

###25287144
OBJECTIVE	We studied the characteristics and clinical outcome related to diuretic response and the effects of serelaxin in patients hospitalized for acute heart failure ( AHF ) .
RESULTS	RELAX-AHF was a double-blind , placebo-controlled trial , enrolling 1161 patients admitted to hospital for AHF who were randomized to 48 h i.v infusions of placebo or serelaxin ( 30 g/kg per day ) within 16 h from presentation .
RESULTS	Diuretic response was defined as weight kg / [ ( total i.v. dose ) / 40 mg ] + [ ( total oral dose ) / 80 mg ) ] furosemide ( or equivalent loop diuretic dose ) up to day 5 .
RESULTS	Median diuretic response was -0.42 ( -1.00 , -0.14 ) kg/40 mg .
RESULTS	A poor diuretic response was independently associated with Western-like region ( Western Europe , North America , Israel , and Poland ) , lower diastolic blood pressure , the absence of oedema , higher blood urea nitrogen , and lower levels of aspartate aminotransferase and potassium ( all P < 0.01 ) .
RESULTS	Randomization to serelaxin was associated with lower doses of i.v. loop diuretics and slightly less weight loss , resulting in a neutral effect on diuretic response .
RESULTS	Worse diuretic response was independently associated both with less relief of dyspnoea , measured with a visual analogue scale ( VAS ) at day 5 ( primary endpoint ; P = 0.0002 ) , and with a higher risk of cardiovascular death or rehospitalization for heart failure or renal failure through day 60 ( secondary endpoint , P < 0.0001 ) , but not with increased 180-day cardiovascular mortality ( P = 0.507 ) .
CONCLUSIONS	In patients hospitalized for AHF , a poor diuretic response was associated with a poor in-hospital and early post-discharge clinical outcome .
CONCLUSIONS	Serelaxin had a neutral effect on diuretic response .
BACKGROUND	NCT00520806 .

###24229598
OBJECTIVE	To compare the therapeutic effect of probiotics and oral immunoglobulin on pediatric rotavirus enteritis .
METHODS	A randomized , controlled trial was conducted in 150 children with rotavirus enteritis who were randomly divided into control , probiotic and immunoglobulin groups ( n = 50 each ) .
METHODS	In addition to basic treatment , the control group was given placebo , the probiotic group was given live combined bifidobacterium and lactobacillus tablets , and the immunoglobulin group was orally given anti-rotavirus egg yolk immunoglobulin ( IgY ) .
METHODS	Clinical symptoms such as stool frequency and stool properties were recorded every day .
METHODS	Fresh stool samples were collected on days 1 , 3 , 5 , 7 , 9 and 11 of treatment .
METHODS	Intestinal flora imbalance was detected and divided into three degrees by microscopic examination of stool .
METHODS	Fecal SIgA level and fecal rotavirus shedding were measured by radioimmunoassay and double-antibody sandwich ELISA respectively .
RESULTS	Compared with the control group , the probiotic group had reduced intestinal flora imbalance , decreased stool frequency , and reduced incidence of secondary intestinal bacterial infection after 3 days of treatment ( P < 0.05 ) .
RESULTS	There was no significant difference in disease course between the probiotic and control groups .
RESULTS	Compared with the control group , the immunoglobulin group had a significantly increased fecal SIgA level after 1 day of treatment ( P < 0.05 ) , significantly decreased frequency of diarrhea and fecal rotavirus shedding after 3 days of treatment ( P < 0.05 ) , and a significantly shorter disease course ( 4.51.0 vs 5.81.7 days ; P < 0.05 ) .
CONCLUSIONS	For children with rotavirus enteritis , probiotics can reduce intestinal flora imbalance and prevent secondary intestinal bacterial infection , but probiotics take a long time to relieve clinical symptoms and can not shorten the course of disease .
CONCLUSIONS	Oral immunoglobulin takes effect quickly and can rapidly eliminate rotavirus , promote the production of SIgA , and shorten the course of disease .

###24732962
BACKGROUND	Many patients with obsessive-compulsive disorder ( OCD ) do not receive first-line treatment according to the current guidelines ( cognitive behavioral therapy with exposure and response prevention , CBT with ERP ) due to barriers to treatment .
BACKGROUND	Internet-based therapy is designed to overcome these barriers .
BACKGROUND	The present study evaluates the efficacy of an Internet-based writing therapy with therapeutic interaction based on the concept of CBT with ERP for patients with OCD .
METHODS	Thirty-four volunteers with OCD according to DSM-IV-criteria were included in the trial and randomized according to a waiting-list control design with follow-up measures at 8 weeks and 6 months .
METHODS	The intervention consisted of 14 sessions , either starting directly after randomization or with an 8-week delay .
METHODS	Main outcome measure was the change in the severity of OCD symptoms ( Yale-Brown Obsessive Compulsive Scale Self-Rating , Y-BOCS SR , and Obsessive-Compulsive Inventory-Revised , OCI-R ) .
RESULTS	Obsessive-compulsive symptoms were significantly improved in the treatment group compared to the waiting-list control group with large effect sizes of Cohen 's d = 0.82 ( Y-BOCS SR ) and d = 0.87 ( OCI-R ) , using an intention-to-treat analysis .
RESULTS	This effect remained stable at 6-month follow-up .
RESULTS	Only 4 participants ( 12 % ) dropped out prematurely from the study .
RESULTS	Of the 30 completers , 90 % rated their condition as improved and would recommend the program to their friends .
CONCLUSIONS	Internet-based writing therapy led to a significant improvement of obsessive-compulsive symptoms .
CONCLUSIONS	Even though replications with larger sample sizes are needed , the results support the notion that Internet-based approaches have the potential for improving the treatment situation for patients with OCD .

###24625625
OBJECTIVE	To evaluate whether subjects with knee or hip osteoarthritis ( OA ) pain on non-steroidal anti-inflammatory drugs ( NSAIDs ) received greater benefit when tanezumab monotherapy replaced or was coadministered with NSAIDs .
METHODS	Subjects ( N = 2700 ) received intravenous tanezumab ( 5 or 10mg ) or placebo every 8weeks with or without oral naproxen 500mg twice daily or celecoxib 100mg twice daily .
METHODS	Efficacy was assessed as change from baseline to week 16 in three co-primary endpoints : Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) Pain , WOMAC Physical Function and Patient 's Global Assessment ( PGA ) of OA .
METHODS	Safety assessments included adverse events , physical and neurological examinations , laboratory tests and vital signs .
RESULTS	Although all tanezumab treatments provided significant improvements in WOMAC Pain and Physical Function over either NSAID alone , only tanezumab + NSAIDs were significant versus NSAIDs with PGA and met the prespecified definition of superiority .
RESULTS	Combination treatment did not substantially improve pain or function over tanezumab monotherapy .
RESULTS	Adverse event frequency was higher with tanezumab than with NSAIDs and highest with combination therapy .
RESULTS	Higher incidence of all-cause total joint replacements occurred with tanezumab + NSAID versus tanezumab monotherapy or NSAIDs .
RESULTS	Rapidly progressive OA incidence was significantly greater versus NSAID in all tanezumab groups except tanezumab 5mg monotherapy .
CONCLUSIONS	Subjects receiving partial symptomatic relief of OA pain with NSAIDs may receive greater benefit with tanezumab monotherapy .
CONCLUSIONS	While only coadministration of tanezumab with NSAIDs met the definition of superiority , combination treatment did not provide important benefits over tanezumab monotherapy ; small differences in efficacy were negated by treatment-limiting or irreversible safety outcomes .
BACKGROUND	NCT00809354 .

###26062190
OBJECTIVE	To explore the effect of auricular point sticking before operation for postoperative complications of external excision and internal ligation on mixed hemorrhoid .
METHODS	Eighty patients with mixed hemorrhoid were randomly divided into an observation group and a control group , 40 cases in each group .
METHODS	In the control group , paracetamol and dihydrocodeine tartrate tablets were applied with oral administration 1 h after operation , 510 mg each time , twice a day ; at the same time , diosmin tablets were treated with oral administration , 0.9 g each time , twice a day .
METHODS	Three days ' treatments were required successively .
METHODS	In the observation group , auricular point sticking was used before operation based on the treatment in the control group .
METHODS	The auricular points of Shen ( Co10 ) , Pangguang ( CO9 ) , Shenmen ( TF4 ) , Pizhixia ( AT4 ) , Jiaogan ( AH6a ) and Gangmen ( HX5 ) were selected .
METHODS	The patients were asked to press the points 3-6 times per day , 3-5 min each time , 3 days ' treatment in total .
METHODS	The scores of the postoperative complications in the 1st and the 2nd days were compared between the two groups such as pain , edema , hematochezia , retention of urine , etc. .
RESULTS	After operation , the scores of pain , edema , hematochezia , retention of urine in the 2nd day were all decreased obviously than those in the 1st day in the two groups ( all P < 0.05 ) ; and the scores of pain , edema , hematochezia , retention of urine in the 1st and the 2nd days of the observation group were lower than those in the control group ( all P < 0.05 ) .
CONCLUSIONS	Auricular point sticking before operation combined with conventional western medicine with oral administration for preventing and treating postoperative complications of external excision and internal ligation on mixed hemorrhoid achieves positive and reliable efficacy .

###24885938
BACKGROUND	Providing restorative treatment for persons with disability may be challenging and has been related to the patient 's ability to cope with the anxiety engendered by treatment and to cooperate fully with the demands of the clinical situation .
BACKGROUND	The aim of the present study was to assess the survival rate of ART restorations compared to conventional restorations in people with disability referred for special care dentistry .
METHODS	Three treatment protocols were distinguished : ART ( hand instruments/high-viscosity glass-ionomer ) ; conventional restorative treatment ( rotary instrumentation/resin composite ) in the clinic ( CRT/clinic ) and under general anaesthesia ( CRT/GA ) .
METHODS	Patients were referred for restorative care to a special care centre and treated by one of two specialists .
METHODS	Patients and/or their caregivers were provided with written and verbal information regarding the proposed techniques , and selected the type of treatment they were to receive .
METHODS	Treatment was provided as selected but if this option proved clinically unfeasible one of the alternative techniques was subsequently proposed .
METHODS	Evaluation of restoration survival was performed by two independent trained and calibrated examiners using established ART restoration assessment codes at 6 months and 12 months .
METHODS	The Proportional Hazard model with frailty corrections was applied to calculate survival estimates over a one year period .
RESULTS	66 patients ( 13.67.8 years ) with 16 different medical disorders participated .
RESULTS	CRT/clinic proved feasible for 5 patients ( 7.5 % ) , the ART approach for 47 patients ( 71.2 % ) , and 14 patients received CRT/GA ( 21.2 % ) .
RESULTS	In all , 298 dentine carious lesions were restored in primary and permanent teeth , 182 ( ART ) , 21 ( CRT/clinic ) and 95 ( CRT/GA ) .
RESULTS	The 1-year survival rates and jackknife standard error of ART and CRT restorations were 97.81.0 % and 90.53.2 % , respectively ( p = 0.01 ) .
CONCLUSIONS	These short-term results indicate that ART appears to be an effective treatment protocol for treating patients with disability restoratively , many of whom have difficulty coping with the conventional restorative treatment .
BACKGROUND	Netherlands Trial Registration : NTR 4400 .

###24345453
OBJECTIVE	To assess the effects of different nasal continuous positive airway pressure ( nCPAP ) pressures on cardiac performance in preterm infants with minimal lung disease , we conducted a randomized , blinded crossover study .
METHODS	We studied infants between 28 and 34 weeks ' corrected gestational age , treated with nCPAP of 5cm H2O , in air .
METHODS	Infants with significant cardiac shunts were excluded .
METHODS	Infants were randomly assigned to nCPAP levels of 4 , 6 , and 8 cm H2O for 15 minutes each .
METHODS	Right and left ventricular outputs and left pulmonary artery and superior vena cava flows were measured 15 minutes after each change .
RESULTS	Thirty-four infants born at a mean gestational age of 29 weeks with a birth weight of 1.3 kg were studied .
RESULTS	There were no significant differences in right and left ventricular outputs and left pulmonary artery and superior vena cava flows at different levels of nCPAP .
CONCLUSIONS	We investigated the effect of increasing nCPAP levels on cardiac output .
CONCLUSIONS	We conclude that nCPAP levels between 4 and 8 cm H2O did not have an effect on cardiac output in stable preterm infants with minimal lung disease .

###24744165
BACKGROUND	Low and high dialysate calcium ( Ca ) content may have positive and harmful effects depending on the considered pathological aspect : hemodynamic instability , cardiac arrhythmias , parathormone release , adynamic bone disease , cardio-vascular calcifications .
BACKGROUND	We hypothesized that a time-profiled Ca concentration would keep the cardiovascular advantages of high Ca but would reduce the risk of calcium overload .
METHODS	A prospective , multicenter study using a particular hemodiafiltration technique that allows the profiling of electrolytes was designed .
METHODS	Patients ( n = 22 ) underwent randomly a 3-week dialysis session with low and high constant dialysate Ca ( Ld ( Ca , ) , 1.25 mM and Hd ( Ca , ) , 2 mM ) and profiled Ca ( Pd ( Ca ) ) , respectively .
METHODS	Plasma and spent dialysate Ca , systolic and diastolic arterial pressure ( SAP , DAP ) and QT interval corrected for heart rate ( QTc ) were analyzed .
RESULTS	Plasma Ca concentration decreased in Ld ( Ca ) , whereas it increased in Hd ( Ca ) and to a lesser extent , in Pd ( Ca ) .
RESULTS	Total amount of Ca given to the patient in Pd ( Ca ) ( 15.5 1.0 mmol ) was higher than in Ld ( Ca ) ( 4.3 1.6 mmol ) but lower than in Hd ( Ca ) ( 21.9 3.3 mmol ) .
RESULTS	SAP and DAP decreased in Ld ( Ca ) , whereas it was almost constant in both Hd ( Ca ) and Pd ( Ca ) .
RESULTS	QTc significantly increased , up to critical values ( > 460 msec ) , only during Ld ( Ca ) .
CONCLUSIONS	Pd ( Ca ) seems to retain the advantages of high Ca in terms of hemodynamic stability and modification of QTc while reducing the excessive positive calcium balance typical of dialysis with high Ca content .

###25113139
BACKGROUND	Sedentary behavior is regarded as a distinct risk factor for cardiometabolic morbidity and mortality , but knowledge of the efficacy of interventions targeting reductions in sedentary behavior is limited .
OBJECTIVE	To investigate the effect of an individualized face-to-face motivational counseling intervention aimed at reducing sitting time .
METHODS	A randomized , controlled , observer-blinded , community-based trial with two parallel groups using open-end randomization with 1:1 allocation .
METHODS	A total of 166 sedentary adults were consecutively recruited from the population-based Health2010 Study .
METHODS	Participants were randomized to a control ( usual lifestyle ) or intervention group with four individual theory-based counseling sessions .
METHODS	Objectively measured overall sitting time ( ActivPAL 3TM , 7 days ) ; secondary measures were breaks in sitting time , anthropometric measures , and cardiometabolic biomarkers , assessed at baseline and after 6 months .
METHODS	Data were collected in 2010-2012 and analyzed in 2013-2014 using repeated measures multiple regression analyses .
RESULTS	Ninety-three participants were randomized to the intervention group and 73 to the control group , and 149 completed the study .
RESULTS	The intervention group had a mean sitting time decrease of -0.27 hours/day , corresponding to 2.9 % of baseline sitting time ( hours/day ) ; the control group increased mean sitting time by 0.06 hours/day .
RESULTS	The between-group difference in change , -0.32 hours/day ( 95 % CI = -0.87 , 0.24 , p = 0.26 ) , was not statistically significant .
RESULTS	Significant differences in change in fasting serum insulin of -5.9 pmol/L ( 95 % CI = -11.4 , -0.5 , p = 0.03 ) ; homeostasis model assessment-estimated insulin resistance of -0.28 ( 95 % CI = -0.53 , -0.03 , p = 0.03 ) ; and waist circumference of -1.42 cm ( 95 % CI = -2.54 , -0.29 , p = 0.01 ) were observed in favor of the intervention group .
CONCLUSIONS	Although the observed decrease in sitting time was not significant , a community-based , individually tailored , theory-based intervention program aimed at reducing sitting time may be effective for increasing standing and improving cardiometabolic health in sedentary adults .
BACKGROUND	This study is registered at Clinicaltrials.gov ( NCT00289237 ) .

###26182779
BACKGROUND	Cirrhosis of liver is the leading cause of portal hypertension in this part of the globe .
BACKGROUND	Around thirty percent of the patient with portal hypertension develops complications .
BACKGROUND	Oesophageal variceal bleeding is a serious complication of portal hypertension .
BACKGROUND	Oesophageal variceal band ligation ( EVBL ) has become the standard of care for patients with bleeding oesophageal varices .
BACKGROUND	Multiple sessions of band ligation are cumbersome and expensive .
METHODS	Sixty patients with acute variceal bleed were enrolled in this randomized control trial .
METHODS	Patients were randomly assigned to multi-session ( group A ) or single session ( group B ) oesophageal variceal band ligation group .
METHODS	All .
METHODS	patients were followed for re-bleeding and mortality up to three months .
RESULTS	Re-bleeding occurred ( 20 % ) in group A and ( 17 % ) in group B patients , respectively .
RESULTS	Mortality was 10 % in group A and 7 % in group B patients .
RESULTS	Variceal obliteration was better in group A 63 % than group B 24 % ( p < 0.05 ) .
CONCLUSIONS	Single session band ligation was comparable for rates of re-bleeding and mortality to multi-session band ligation .

###24872684
BACKGROUND	Cardiovascular disease ( CVD ) is a common problem of middle-aged and older adults .
BACKGROUND	Increased arterial stiffness is a CVD risk factor .
BACKGROUND	Whole-body vibration ( WBV ) is a simple and convenient exercise for middle-aged and older adults ; however , there have been few studies investigating the effect of WBV on arterial stiffness .
BACKGROUND	This study mainly investigated the effect of WBV on arterial stiffness in middle-aged and older adults .
METHODS	A total of 38 ( 21 women and 17 men ) middle-aged and elderly subjects ( average age , 61.9 years ) were randomly divided into the WBV group and the control group for a 3-month trial .
METHODS	The WBV group received an intervention of 30 Hz and 3.2 g WBV in a natural full standing posture at a sports center .
METHODS	The brachial-ankle pulse wave velocity ( baPWV ) , a marker of systemic arterial stiffness , and blood pressure and heart rate were measured before and after the intervention .
RESULTS	After 3 months , there were no significant changes in blood pressure or heart rate in both groups .
RESULTS	However , the bilateral baPWV was significantly reduced in the WBV group ( decreased by 0.65 m/second [ P = 0.014 ] ; 0.63 m/second [ P = 0.041 ] in either side ) , but not in the control group .
RESULTS	The comparison between the two groups was not statistically significant .
CONCLUSIONS	This study found that 3 months of WBV had a positive effect on arterial stiffness in middle-aged and older adults and could therefore be regarded as a supplementary exercise .
CONCLUSIONS	Larger-scale studies are needed to confirm the effects of WBV in the future .

###25391306
OBJECTIVE	To determine whether haemoperfusion ( HP ) with continuous venovenous haemofiltration ( CVVH ) improves the survival of patients with acute paraquat poisoning , compared with those treated using HP alone .
METHODS	Medical records of patients with acute paraquat poisoning were analysed .
METHODS	Patients were randomised to undergo HP or HP + CVVH within 24 h of paraquat ingestion .
METHODS	Mortality rate , survival duration and cause of death were recorded .
RESULTS	There were no significant differences in mortality rate between the HP group ( n = 458 ) and the HP + CVVH group ( n = 226 ) ( 57.4 % and 58.4 % , respectively ) .
RESULTS	The mean survival duration was significantly longer in the HP + CVVH group than the HP group ( 8.6 3.1 and 5.1 2.3 days , respectively ) .
RESULTS	Early circulatory collapse was a major cause of death in the HP group .
RESULTS	The major cause of death in the HP + CVVH group was late respiratory failure .
CONCLUSIONS	Combined therapy with HP and CVVH can prevent early death and prolong survival duration following acute paraquat poisoning , providing the opportunity for further treatment .

###24264126
OBJECTIVE	To compare the safety and efficiency of thulium laser resection of the prostate-tangerine technique ( TmLRP-TT ) and plasmakinetic resection of the prostate ( PKRP ) for aged symptomatic benign prostatic hyperplasia ( BPH ) patients with large volume prostates ( > 80 ml ) in a prospective randomized trial with an 18-month follow-up .
METHODS	From January 2010 to November 2011 , 90 BPH patients with large volume prostates were randomized for surgical treatment with TmLRP-TT ( n = 45 , group 1 ) or PKRP ( n = 45 , group 2 ) .
METHODS	The preoperative and postoperative parameters were recorded and compared .
METHODS	All patients were evaluated at 1 , 6 , 12 and 18 months postoperatively using the International Prostate Symptom Score ( IPSS ) , quality of life score ( QoL ) , maximum flow rate ( Q max ) , postvoid residual urine volume ( PVR ) and the five-item version of the International Index of Erectile Function score .
METHODS	All perioperative complications were also documented and classified according to the modified Clavien classification system .
RESULTS	Compared with the PKRP group , the TmLRP-TT group had a statistically lower hemoglobin drop ( 0.86 0.42 vs. 1.34 1.04 g/dl , P < 0.01 ) , shorter catheterization time ( 1.91 0.85 vs. 2.36 0.74 days , P < 0.01 ) and hospital stay ( 3.80 0.46 vs. 5.02 0.54 days , P < 0.01 ) .
RESULTS	Within the observation period of 18 months , both groups had significant postoperative improvement in IPSS , QoL , Q max and PVR , although no difference was observed between the two groups .
RESULTS	Only one patient receiving PKRP treatment required a blood transfusion perioperatively .
RESULTS	During the 18-month follow-up , one patient in each group experienced urethral stricture and one patient in the PKRP group experienced bladder neck contracture .
RESULTS	Minor complications that required no or noninterventional treatment occurred in 6 ( 13.33 % ) of TmLRP-TT group ( Clavien grade 1 , 13.33 % and grade 2 , 0 % ) and 10 ( 22.22 % ) of PKRP group ( Clavien grade 1 , 20.00 % and grade 2 , 2.22 % ) .
RESULTS	No severe complications required reinterventions in both groups ( Clavien grade 3 , 0 % ; grade 4 , 0 % ; grade 5 , 0 % ) .
CONCLUSIONS	Both TmLRP-TT and PKRP are safe and effective treatment options for large prostates that require resection .
CONCLUSIONS	Taking into account less blood loss , shorter catheterization time and hospital stay , TmLRP-TT may be a better treatment for patients with large prostates .

###24570981
OBJECTIVE	To evaluate whether 6 mm long by 4 mm wide dental implants could be an alternative to implants at least 10 mm long placed in bone augmented with bone substitutes in posterior atrophic jaws .
METHODS	A total of 20 patients with bilateral atrophic mandibles and 20 patients with bilateral atrophic maxillae , having 5 to 7 mm of bone height above the mandibular canal or below the maxillary sinus , had each side of the jaws randomly allocated according to a split-mouth design .
METHODS	They were allocated to receive one to three 6 mm long and 4 mm wide implants , or implants at least 10 mm long in augmented bone by two different surgeons in different centres .
METHODS	Mandibles were vertically augmented with interpositional equine bone blocks and resorbable barriers , and implants were placed 3 months later .
METHODS	Maxillary sinuses were augmented with particulated porcine bone via a lateral window and implants were placed simultaneously .
METHODS	All implants were submerged and loaded , after 4 months , with provisional prostheses .
METHODS	Four months later , definitive metal-ceramic prostheses were delivered .
METHODS	Outcome measures were prosthesis and implant failures , any complication and radiographic peri-implant marginal bone level changes .
RESULTS	One patient treated in the mandible dropped out before the 1-year post-loading follow-up .
RESULTS	All maxillary implants and prostheses were successful , whereas 2 mandibular prostheses could not be placed on implants at least 10 mm long due to graft failures ; one was associated with the loss of 3 implants because of infection .
RESULTS	There were no statistically significant differences in implant and prosthesis failures , though significantly more complications occurred at grafted sites in mandibles ( P = 0.0078 ) , but not in maxillae ( P = 0.1250 ) .
RESULTS	In total , 14 complications occurred in 12 patients at augmented sites versus none at 6 mm-long implants .
RESULTS	All failures and complications occurred before loading .
RESULTS	Patients with mandibular 6 mm-long implants lost an average of 1.05 mm of peri-implant bone at 1 year and patients with mandibular implants at least 10 mm long lost 1.07 mm .
RESULTS	These differences were statistically significant ( P < 0.001 ) .
RESULTS	Patients with maxillary 6 mm-long implants lost an average of 1.02 mm of peri-implant bone at 1 year and patients with maxillary implants at least 10 mm long lost 1.09 mm .
RESULTS	These differences were statistically significant ( P < 0.001 ) .
RESULTS	There were no statistically significant differences in bone level changes up to 1 year between 6 mm and at least 10 mm-long implants in both jaws ( mandibles n = 18 , mean difference -0.02 mm , 95 % CI -0.16 to 0.12 , P = 0.7384 ; maxillae n = 20 , mean difference -0.07 mm , 95 % CI -0.18 to 0.05 , P = 0.2547 ) .
CONCLUSIONS	Short-term data ( 1 year after loading ) indicate that 6 mm-long implants with a conventional diameter of 4 mm achieved similar if not better results than longer implants placed in augmented bone .
CONCLUSIONS	Short implants might be a preferable choice to bone augmentation , especially in posterior mandibles since the treatment is faster , cheaper and associated with less morbidity .
CONCLUSIONS	However , data obtained 5 to 10 years after loading are necessary before making reliable recommendations .
CONCLUSIONS	CONFLICT OF INTEREST STATEMENT : Tecnoss and Southern Implants partially supported this trial and donated biomaterials , implants and prosthetic components used in this study .
CONCLUSIONS	However , the data belonged to the authors and by no means did the manufacturers interfere with the conduct of the trial or the publication of its results .

###24263699
OBJECTIVE	Patients often report greater visual difficulties at home than expected from vision testing in the clinic .
OBJECTIVE	Such discordance may be owing to worse vision in the home than measured in clinic .
OBJECTIVE	To compare vision measured between the clinic and home and evaluate factors , including lighting , associated with these differences .
METHODS	This cross-sectional study conducted from 2005-2009 involved 126 patients with glaucoma and 49 without glaucoma recruited from the Glaucoma and Comprehensive Eye Clinics at Washington University , St Louis , Missouri .
METHODS	Patients underwent clinic and home visits , were aged 55 to 90 years , were consecutively recruited , and met inclusion criteria for this study .
METHODS	A total of 166 eligible patients refused participation .
METHODS	Participants underwent clinic and home visits randomized to order of completion .
METHODS	At each visit , masked and certified examiners measured binocular distance visual acuity ( DVA ) with a nonbacklit chart , near visual acuity ( NVA ) , contrast sensitivity ( CS ) , CS with glare , and lighting .
METHODS	Differences in vision between the clinic and home .
RESULTS	The mean scores for all vision tests were significantly better in the clinic than home for participants with and without glaucoma ( P < .05 , matched-pair t tests ) .
RESULTS	For DVA , 29 % of participants with glaucoma read 2 or more lines better in the clinic than home and 39 % with advanced glaucoma read 3 or more lines better .
RESULTS	For the entire sample , 21 % of participants read 2 or more lines better in the clinic than home for NVA and 49 % read 2 or more triplets better in the clinic for CS with glare .
RESULTS	Lighting was the most significant factor associated with differences in vision between the clinic and home for DVA , NVA , and CS with glare testing ( P < .05 , multiple regression model ) .
RESULTS	Median home lighting was 4.3 times and 2.8 times lower than clinic lighting in areas tested for DVA and NVA , respectively .
RESULTS	Home lighting was below that recommended in 85 % or greater of participants .
CONCLUSIONS	Vision measured in the clinic is generally better than vision measured at home , with differences mainly owing to poor home lighting .
CONCLUSIONS	Knowledge that vision discrepancies between patient report and clinical testing may be owing to home lighting may initiate clinician-patient discussions to optimize home lighting and improve the vision of older adults in their homes .

###24418570
BACKGROUND	Neuromuscular electrical stimulation ( NMES ) improves muscle performance and exercise tolerance in chronic obstructive pulmonary disease ( COPD ) patients .
BACKGROUND	In contrast , no study has assessed the effect of NMES on dynamic hyperinflation ( DH ) in COPD .
BACKGROUND	This study investigated the effect of short-term , high-frequency NMES on DH in patients with COPD .
METHODS	Twenty patients were randomly allocated to either a NMES applied bilaterally to the quadriceps muscles ( n = 11 : 8 weeks , 5 days/week , twice/day , 45 min/session ) or a control group ( n = 09 ) .
METHODS	All patients received respiratory physical therapy and stretching exercises .
METHODS	Free fat mass , pulmonary function , time to exercise tolerance ( Tlim ) , 6-min walk test distance ( 6-MWTD ) , tumor necrosis factor ( TNF - ) and - endorphin levels , Borg dyspnea and leg score ( BDS and BLS ) and quality of life by the St. George 's Respiratory Questionnaire score ( SGRQ ) were examined before and after the intervention .
RESULTS	Compared with the control group , NMES increased FEV1 and FEV1/FVC , 6-MWD and Tlim ( P < 0.01 ) and reduced BDS and SGRQ ( P < 0.01 ) .
RESULTS	Additionally , changes in the Tlim were positively correlated with respiratory improvements in FEV1 ( rho = 0.48 , P < 0.01 ) .
RESULTS	Also , NMES reduced TNF - and increased - endorphin levels , compared with the control group ( P < 0.001 ) .
CONCLUSIONS	In summary , 8 weeks of NMES promotes reduction of the perceived sensation of dyspnea during exercise in patients with COPD .
CONCLUSIONS	This finding is accompanied by improvements in FEV1 , exercise tolerance and quality of life , and DH .
CONCLUSIONS	Interestingly , these findings may be associated with enhanced vasodilatory function and a reduction in inflammatory responses .
BACKGROUND	NCT01695421 .

###24375295
BACKGROUND	Small pigtail catheters appear to work as well as the traditional large-bore chest tubes in patients with traumatic pneumothorax , but it is not known whether the smaller pigtail catheters are associated with less tube-site pain .
BACKGROUND	This study was conducted to compare tube-site pain following pigtail catheter or chest tube insertion in patients with uncomplicated traumatic pneumothorax .
METHODS	This prospective randomized trial compared 14-Fr pigtail catheters and 28-Fr chest tubes in patients with traumatic pneumothorax presenting to a level I trauma centre from July 2010 to February 2012 .
METHODS	Patients who required emergency tube placement , those who refused and those who could not respond to pain assessment were excluded .
METHODS	Primary outcomes were tube-site pain , as assessed by a numerical rating scale , and total pain medication use .
METHODS	Secondary outcomes included the success rate of pneumothorax resolution and insertion-related complications .
RESULTS	Forty patients were enrolled .
RESULTS	Baseline characteristics of 20 patients in the pigtail catheter group were similar to those of 20 patients in the chest tube group .
RESULTS	No patient had a flail chest or haemothorax .
RESULTS	Pain scores related to chest wall trauma were similar in the two groups .
RESULTS	Patients with a pigtail catheter had significantly lower mean ( s.d. ) tube-site pain scores than those with a chest tube , at baseline after tube insertion ( 3.2 ( 0.6 ) versus 7.7 ( 0.6 ) ; P < 0.001 ) , on day 1 ( 1.9 ( 0.5 ) versus 6.2 ( 0.7 ) ; P < 0.001 ) and day 2 ( 2.1 ( 1.1 ) versus 5.5 ( 1.0 ) ; P = 0.040 ) .
RESULTS	The decreased use of pain medication associated with pigtail catheter was not significantly different .
RESULTS	The duration of tube insertion , success rate and insertion-related complications were all similar in the two groups .
CONCLUSIONS	For patients with a simple , uncomplicated traumatic pneumothorax , use of a 14-Fr pigtail catheter is associated with reduced pain at the site of insertion , with no other clinically important differences noted compared with chest tubes .
BACKGROUND	NCT01537289 ( http://clinicaltrials.gov ) .

###25191890
OBJECTIVE	The purpose of this study was to determine the prosthodontic outcomes of one-piece zirconia implants and their attachment systems in edentulous participants with maxillary and mandibular overdentures after 1 year of a randomized controlled trial .
METHODS	Random allocation of 24 edentulous participants ( age range : 45 to 86 years ) into titanium ( control ) or zirconia ( test ) groups using onepiece implants and a planned unsplinted prosthodontic design was performed .
METHODS	Four maxillary implants ( one midpalatal ; three anterior crestal ) and three mandibular implants ( one midsymphyseal ; two bilateral distal ) were conventionally loaded with the overdentures .
METHODS	Similar attachment systems were used throughout : ball abutment-type patrices ( diameter : 2.25 to 3.1 mm as part of the one-piece implants ) and custommade plastic matrices ( with or without metal housings depending on the patrix size ) .
METHODS	Prosthodontic outcomes were documented during the first year of the clinical trial .
RESULTS	Following three deaths and two dropouts , there were 19 participants who were available at the 1-year recall .
RESULTS	Of these participants , 3 had early maxillary implant failure and had to be converted to conventional maxillary complete dentures opposing mandibular implant overdentures .
RESULTS	There were 79 maintenance events , 34 in the titanium ( control ) group and 45 in the zirconia ( test ) group .
RESULTS	Patrix loss occurred as a result of three zirconia implant fractures ( one mandibular and two crestal maxillary implants ) .
RESULTS	Maintenance events were principally the replacement of matrices and overdenture fracture .
RESULTS	Although relines and replacement overdentures also occurred , overall there were no significant differences in prosthodontic maintenance between the control and test groups .
RESULTS	A six-field prosthodontic-success analysis table showed no statistically significant difference between the two groups ; however , 50 % of participants in each group were allocated to the retreatment ( repair ) field , which produced a low prosthodontic success rate .
CONCLUSIONS	Removable overdentures can be used on both one-piece titanium and zirconia implants with these attachment systems , due to no difference in prosthodontic maintenance and success .
CONCLUSIONS	Before recommending routine use of a `` metal-free '' overdenture treatment option in clinical practice , consideration must be given to the success of the implants themselves .

###24518169
OBJECTIVE	Insulin regulates the secretion of insulin-like growth factor I ( IGF-I ) in the newborn , and low levels of IGF-I have been linked to neonatal morbidity .
OBJECTIVE	As part of the Neonatal Insulin Replacement Therapy in Europe Trial , we investigated the impact of early insulin treatment on IGF-I levels and their relationship with morbidity and growth .
METHODS	Prospective cohort analyses of data collected as part of an international randomized controlled trial .
METHODS	Blood samples ( days 1 , 3 , 7 , and 28 ) , were taken for IGF-I bioassay from 283 very low birth weight infants ( < 1500 g ) .
RESULTS	Early insulin treatment led to a late increase in IGF-I levels between day 7 and 28 ( P = .028 ) .
RESULTS	In the first week of life IGF-I levels were lower in infants with early hyperglycemia ; mean difference -0.10 g/L ( 95 % CI -0.19 , -0.02 , P = .02 ) .
RESULTS	Lower levels of IGF-I at day 28 were independently associated with an increased risk of chronic lung disease , OR 3.23 ( 95 % CI , 1.09-9 .10 ) , and greater IGF-I levels were independently associated with better weight gain , 0.10 kg ( 95 % CI , 0.03-0 .33 , P = .02 ) .
CONCLUSIONS	Early intervention with insulin is related to increased IGF-I levels at 28 days .
CONCLUSIONS	Low IGF-I levels are associated with hyperglycemia , increased morbidity , and reduced growth .
CONCLUSIONS	Increasing IGF-I levels may improve outcomes of very low birth weight infants .

###25548329
OBJECTIVE	To determine whether provision of vaccine-health-literacy-promoting information in text message vaccine reminders improves receipt and timeliness of the second dose of influenza vaccine within a season for children in need of 2 doses .
METHODS	During the 2012-2013 season , families of eligible 6-month through 8-year-old children were recruited at the time of their first influenza vaccination from 3 community clinics in New York City .
METHODS	Children ( n = 660 ) were randomly assigned to `` educational '' text message , `` conventional '' text message , and `` written reminder-only '' arms .
METHODS	At enrollment , all arms received a written reminder with next dose due date .
METHODS	Conventional messages included second dose due date and clinic walk-in hours .
METHODS	Educational messages added information regarding the need for a timely second dose .
METHODS	Receipt of second dose by April 30 was assessed by using ( 2 ) tests .
METHODS	Timeliness was assessed by receipt of second dose by 2 weeks after due date ( day 42 ) using ( 2 ) and over time using a Kaplan-Meier analysis .
RESULTS	Most families were Latino and publicly insured with no significant between-arm differences between groups .
RESULTS	Children in the educational arm were more likely to receive a second dose by April 30 ( 72.7 % ) versus conventional ( 66.7 % ) versus written reminder-only arm ( 57.1 % ; P = .003 ) .
RESULTS	They also had more timely receipt by day 42 ( P < .001 ) and over time ( P < .001 ) .
CONCLUSIONS	In this low-income , urban , minority population , embedding health literacy information improved the effectiveness of text message reminders in promoting timely delivery of a second dose of influenza vaccine , compared with conventional text messages and written reminder only .

###24473244
OBJECTIVE	The purpose of this single-blinded , randomized controlled study was to examine and compare the immediate and retention effects of progressive speed-dependent treadmill training ( SDTT ) and rhythmic auditory-cued ( RAC ) training on balance function , fall incidence , and quality of life ( QOL ) in individuals with PD .
METHODS	Twenty participants ( mean age 66.1 yrs ) with idiopathic PD were randomized into either SDTT ( n = 10 ) or RAC ( n = 10 ) progressive , interval-based locomotor training for 6 weeks .
METHODS	Measures included the Berg Balance Scale ( BBS ) , Rapid Step-Up Test ( RST ) , Activities-specific Balance Confidence Scale , Parkinson 's Disease Questionnaire-39 ( PDQ ) , and the NeuroCom Sensory Organization Test ( SOT ) , Motor Control Test , and Limits of Stability ( LOS ) .
METHODS	Fall incidence was assessed prospectively post-training based on six monthly self-report fall calendars .
RESULTS	Significant gains in balance measures were observed post-training in BBS , RST and SOT for the RAC group and in RST , SOT and LOS for the SDTT group .
RESULTS	Gains were retained at 3 months post-training in all measures for RAC group , but only the RST for the SDTT group .
RESULTS	No clear trend in reduction in fall frequency was evident .
CONCLUSIONS	Externally-cued locomotor training paradigms with progressive speed challenges produced significant improvements in dynamic balance function in persons with PD , with stronger retention of gains in RAC group .

###25403881
OBJECTIVE	To compare the effectiveness of the endolymphatic duct blockage ( EDB ) and the endolymphatic sac decompression ( ESD ) to control Mnire 's disease symptoms and to evaluate their effect on hearing level .
METHODS	Prospective nonblinded randomized study .
METHODS	Tertiary medical center .
METHODS	Fifty-seven patients affected by a refractory Mnire 's disease were included out of which 22 underwent an ESD and 35 underwent an EDB .
METHODS	Five periods of follow-up were considered : 0 to 1 week , 1 week to 6 months , 6 to 12 months , 12 to 18 months , and 18 to 24 months .
METHODS	Mean outcome measurements consisted of vertigo control , tinnitus , aural fullness , instability , and hearing level .
METHODS	Hearing level was evaluated using pure-tone average ( PTA ) and speech discrimination score ( SDS ) .
RESULTS	There was no significant difference between the 2 groups in the number of vertigo spells per months preoperatively ( P = .153 ) .
RESULTS	Twenty-four months postoperatively , 96.5 % of the EDB group had achieved a complete control of vertigo spells against 37.5 % of the ESD group with a statistically significant difference ( P = .002 ) .
RESULTS	There was a better control of tinnitus and aural fullness with EDB ( P = .021 and P = .014 , respectively ) .
RESULTS	There was no statistically significant difference in hearing level preoperatively ( P = .976 ) and 24 months postoperatively ( P = .287 ) between the 2 groups .
RESULTS	Hearing level was preserved in each group with no significant difference between the preoperative and the postoperative levels ( P > .05 ) .
CONCLUSIONS	EDB is more effective than the traditional ESD in controlling the symptoms of Mnire 's disease .
CONCLUSIONS	It is a novel surgical technique with promising results for a complete treatment of Mnire 's disease .
CONCLUSIONS	There are no significant complications or adverse effect .

###25194106
OBJECTIVE	Organ motion is a contributory factor to the variation in location of the prostate and organs at risk during a course of fractionated prostate radiation therapy ( RT ) .
OBJECTIVE	A prospective randomized controlled trial was designed with the primary endpoint to provide evidence-based bladder-filling instructions to achieve a consistent bladder volume ( BV ) and thus reduce the bladder-related organ motion .
OBJECTIVE	The secondary endpoints were to assess the incidence of acute and late genitourinary ( GU ) and gastrointestinal ( GI ) toxicity for patients and patients ' satisfaction with the bladder-filling instructions .
METHODS	One hundred ten patients were randomly assigned to 1 of 2 bladder-filling protocols ; 540 mL ( 3 cups ) of water or 1080 mL ( 6 cups ) of water , in a single institution trial .
METHODS	A portable ultrasound device , BladderScan BVI 6400 ( Verathon Inc , Bothell , WA ) , measured BVs at treatment planning computed tomography ( TPCT ) scan and 3 times per week during RT. .
METHODS	Maximum bladder dose and BV receiving 50 , 60 , and 70 Gy were recorded .
METHODS	Acute and late GU and GI toxicity were evaluated , as were patients ' comfort , perception of urinary symptoms , and quality of life ( QoL ) .
RESULTS	There was significantly less BV variation in the 540 mL arm when compared with 1080 mL ( median : 76 mL vs 105 mL , P = .003 ) .
RESULTS	Larger BVs on initial TPCT correlated with larger BV variations during RT ( P < .0005 ) .
RESULTS	There were no statistically significant associations between arm and GU/GI toxicity , dose median comfort scores , or median QoL scores .
CONCLUSIONS	The 540 mL bladder-filling arm resulted in reproducible BVs throughout a course of RT , without any deterioration in QoL or increase in toxicities for prostate patients .

###24629994
BACKGROUND	Rotavirus is the most common cause of severe dehydrating gastroenteritis in developing countries .
BACKGROUND	Safe , effective , and affordable rotavirus vaccines are needed in these countries .
BACKGROUND	We aimed to assess the efficacy and tolerability of a monovalent human-bovine rotavirus vaccine for severe rotavirus gastroenteritis in low-resource urban and rural settings in India .
METHODS	We did a randomised double-blind , placebo-controlled , multicentre trial at three sites in Delhi ( urban ) , Pune ( rural ) , and Vellore ( urban and rural ) between March 11 , 2011 , and Nov 5 , 2012 .
METHODS	Infants aged 6-7 weeks were randomly assigned ( 2:1 ) , via a central interactive voice or web response system with a block size of 12 , to receive either three doses of oral human-bovine natural reassortant vaccine ( 116E ) or placebo at ages 6-7 weeks , 10 weeks , and 14 weeks .
METHODS	Infants ' families , study investigators , paediatricians in referral hospitals , laboratory staff , and committee members were all masked to treatment allocation .
METHODS	The primary outcome was incidence of severe rotavirus gastroenteritis ( 11 on the Vesikari scale ) .
METHODS	Efficacy outcomes and adverse events were ascertained through active surveillance .
METHODS	Analysis was by intention to treat and per protocol .
METHODS	The trial is registered with Clinical Trial Registry-India ( CTRI/2010/091 / 000102 ) and ClinicalTrials.gov ( NCT01305109 ) .
RESULTS	4532 infants were assigned to receive the 116E vaccine and 2267 to receive placebo , of whom 4354 ( 96 % ) and 2187 ( 96 % ) infants , respectively , were included in the primary per-protocol efficacy analysis .
RESULTS	71 events of severe rotavirus gastroenteritis were reported in 4752 person-years in infants in the vaccine group compared with 76 events in 2360 person-years in those in the placebo group ; vaccine efficacy against severe rotavirus gastroenteritis was 536 % ( 95 % CI 350-669 ; p = 00013 ) and 564 % ( 366-701 ; p < 00001 ) in the first year of life .
RESULTS	The number of infants needed to be immunised to prevent one severe rotavirus gastroenteritis episode was 55 ( 95 % CI 37-97 ) .
RESULTS	The incidence of severe rotavirus gastroenteritis per 100 person-years was 15 in the vaccine group and 32 in the placebo group , with an incidence rate ratio of 046 ( 95 % CI 033-065 ) .
RESULTS	Prevalence of immediate , solicited , and serious adverse events was similar in both groups .
RESULTS	One case of urticaria in the vaccine group and one each of acute gastroenteritis and suspected sepsis in the placebo group were regarded as related to the study product .
RESULTS	We recorded six cases of intussusception in the vaccine group and two in the placebo group , all of which happened after the third dose .
RESULTS	25 ( < 1 % ) infants in the vaccine group and 17 ( < 1 % ) in the placebo group died ; no death was regarded as related to the study product .
CONCLUSIONS	Monovalent human-bovine ( 116E ) rotavirus vaccine is effective and well tolerated in Indian infants .
BACKGROUND	Department of Biotechnology and the Biotechnology Industry Research Assistance Council , Government of India ; Bill & Melinda Gates Foundation to PATH , USA ; Research Council of Norway ; UK Department for International Development ; National Institutes of Health , Bethesda , USA ; and Bharat Biotech International , Hyderabad , India .

###25415290
BACKGROUND	This study sought to assess the feasibility of conducting a phase III HIV prevention trial using a multivalent human papillomavirus ( HPV ) vaccine ( Gardasil ; Merck , Whitehouse Station , NJ ) .
METHODS	A total of 479 sexually active women aged 16-24 years in the Western Cape , South Africa , were enrolled in the Efficacy of HPV Vaccine to Reduce HIV Infection ( EVRI ) Trial .
METHODS	Of these , 402 were HIV negative , nonpregnant , and randomized 1:1 to receive Gardasil or a saline placebo vaccine .
METHODS	Vaccine doses were administered at enrollment , month 2 , and month 6 , and participants were followed for 1 month after the third dose .
METHODS	Enrollment HIV , HPV , other sexually transmitted infections ( STIs ) , and cervical cytology were evaluated .
METHODS	Rates of accrual , vaccine compliance , and adherence to protocol were monitored .
RESULTS	High rates of accrual of eligible females to study ( 93 % ) and completion of the 3-dose vaccine series ( 91 % ) were noted , with few protocol violations .
RESULTS	Ineligibility due to reported HIV positivity was 19 % , and another 12 % of those enrolled tested HIV positive .
RESULTS	STI prevalence was high , with 6.2 % , 10.9 % , and 32.8 % testing positive for syphilis , gonorrhea , and chlamydia , respectively .
RESULTS	Cervical prevalence of 1 of 37 HPV types was 71 % .
RESULTS	STI and HPV prevalence was highest among the youngest women ( < 19 years ) .
CONCLUSIONS	Feasibility ( successful accrual , retention , and vaccination ) of conducting randomized placebo-controlled trials of HPV vaccines among HIV high-risk women in South Africa was demonstrated .
CONCLUSIONS	This work demonstrates that phase III HIV prevention trials need to intervene at young ages and screen and treat multiple STIs concurrently to have a measurable impact on HIV acquisition .

###24631099
OBJECTIVE	To evaluate whether automated reminders increase on-time completion of the three-dose human papillomavirus ( HPV ) vaccine series .
METHODS	Ten reproductive health centers enrolled 365 women aged 19-26 to receive dose one of the HPV vaccine .
METHODS	Health centers were matched and randomized so that participants received either routine follow-up ( control ) or automated reminder messages for vaccine doses two and three ( intervention ) .
METHODS	Intervention participants selected their preferred method of reminders - text , e-mail , phone , private Facebook message , or standard mail .
METHODS	We compared vaccine completion rates between groups over a period of 32 weeks .
RESULTS	The reminder system did not increase completion rates , which overall were low at 17.2 % in the intervention group and 18.9 % in the control group ( p = 0.881 ) .
RESULTS	Exploratory analyses revealed that participants who completed the series on-time were more likely to be older ( OR = 1.15 , 95 % CI 1.01-1 .31 ) , report having completed a four-year college degree or more ( age-adjusted OR = 2.51 , 95 % CI 1.29-4 .90 ) , and report three or more lifetime sexual partners ( age-adjusted OR = 3.45 , 95 % CI 1.20-9 .92 ) .
CONCLUSIONS	The study intervention did not increase HPV vaccine series completion .
CONCLUSIONS	Despite great public health interest in HPV vaccine completion and reminder technologies , completion rates remain low .

###24608960
OBJECTIVE	To assess efavirenz plasma concentrations and their association with treatment efficacy and tolerance of efavirenz 600 mg daily in HIV-tuberculosis co-infected patients .
METHODS	HIV-infected adults with CD4 + T cell count 200/mm ( 3 ) received standard 6-month tuberculosis treatment and antiretroviral therapy including a daily-dose of 600 mg of efavirenz , irrespective of their body weight .
METHODS	Mid-dose blood samples were drawn both on tuberculosis treatment ( week +2 and week +6 after antiretroviral therapy initiation , and week 22 of follow-up ) and off tuberculosis treatment ( week 50 of follow-up ) .
METHODS	Considered therapeutic range was 1,000 to 4,000 ng/mL .
METHODS	Multivariate analysis was performed to evaluate the association between efavirenz concentration below 1,000 ng/mL and virological failure .
METHODS	Linear regression was used to test the association between efavirenz exposure and CD4 + T cell gain .
METHODS	Severe side effects potentially related to efavirenz were described and their association with efavirenz exposure was tested by multivariate analysis .
RESULTS	Efavirenz plasma concentrations were available in 540 patients .
RESULTS	Median [ interquartile range ] efavirenz concentrations were 2,674 ng/mL [ 1,690-4 ,533 ] , 2,667 ng/mL [ 1,753-4 ,494 ] and 2,799 ng/mL [ 1,804-4 ,744 ] at week +2 , week +6 , week 22 , respectively , and 2,766 ng/mL [ 1,941-3 ,976 ] at week 50 .
RESULTS	Efavirenz concentrations were lower at week 50 ( off rifampicin ) compared to week 22 ( on rifampicin ) ( p < 0.001 ) .
RESULTS	Late attendance to study visit and low hemoglobinemia were the only factors associated with an increased risk of efavirenz concentration below 1,000 ng/mL .
RESULTS	Efavirenz concentration below 1,000 ng/mL was not associated with treatment failure .
RESULTS	Efavirenz concentration above 4,000 ng/mL was associated with higher risk of central nervous system side effects ( p < 0.001 ) and of hepatotoxicity ( p < 0.001 ) .
CONCLUSIONS	Body weight and tuberculosis treatment were not associated with low efavirenz concentrations or treatment failure , supporting the 600 mg daily-dose of efavirenz in HIV-tuberculosis co-infected patients .
CONCLUSIONS	High efavirenz concentrations were related to a higher risk of central nervous system side effects and hepatotoxicity .
BACKGROUND	ClinicalTrials.gov NCT01300481 .

###25175601
BACKGROUND	Pisa syndrome ( PS ) is a tonic lateral flexion of trunk that represents a disabling complication of advanced Parkinson disease ( PD ) .
BACKGROUND	Conventional rehabilitation treatment ( CT ) ameliorates axial posture and trunk mobility in PD patients , but the improvement tends to wane in 4-6 months .
BACKGROUND	Botulin toxin ( BT ) may reduce muscle hyperactivity , therefore improving CT effectiveness .
BACKGROUND	We evaluated whether the injection of incabotulinum toxin type A ( iBTA ) into the hyperactive trunk muscles might improve the effectiveness of rehabilitation in a group of PD patients with PS .
METHODS	Twenty-six PD patients were enrolled in a randomized placebo-controlled trial .
METHODS	Group A was treated with iBTA before undergoing CT ( a 4-week intensive programme ) , while Group B received saline before the 4-week CT treatment .
METHODS	Patients were evaluated at baseline , at the end of the rehabilitative period , 3 and 6 months with kinematic analysis of movement , UPDRS , Functional Independence Measure and Visual Analog Scale for pain .
RESULTS	At the end of the rehabilitation period , both groups improved significantly in terms of static postural alignment and of range of motion .
RESULTS	Group A showed a significantly more marked reduction in pain score as compared with Group B and a more prolonged efficacy on several clinical and kinematic variables .
CONCLUSIONS	Our preliminary data suggest that BT may be considered an important addition to the rehabilitation programme for PD subjects with PS for improving axial posture and trunk mobility , as well as for a better control of pain .

###26206652
BACKGROUND	The optimal perioperative fluid resuscitation strategy for liver resections remains undefined .
BACKGROUND	Goal-directed therapy ( GDT ) embodies a number of physiologic strategies to achieve an ideal fluid balance and avoid the consequences of over - or under-resuscitation .
METHODS	In a prospective randomized trial , patients undergoing liver resection were randomized to GDT using stroke volume variation as an end point or to standard perioperative resuscitation .
METHODS	Primary outcomes measure was 30-day morbidity .
RESULTS	Between 2012 and 2014 , one hundred and thirty-five patients were randomized ( GDT : n = 69 ; standard perioperative resuscitation : n = 66 ) .
RESULTS	Median age was 57 years and 56 % were male .
RESULTS	Metastatic disease comprised 81 % of patients .
RESULTS	Overall ( 35 % GDT vs 36 % standard perioperative resuscitation ; p = 0.86 ) and grade 3 morbidity ( 28 % GDT vs 18 % standard perioperative resuscitation ; p = 0.22 ) were equivalent .
RESULTS	Patients in the GDT arm received less intraoperative fluid ( mean 2.0 L GDT vs 2.9 L standard perioperative resuscitation ; p < 0.001 ) .
RESULTS	Perioperative transfusions were required in 4 % ( 6 % GDT vs 2 % standard perioperative resuscitation ; p = 0.37 ) and boluses in the postanesthesia care unit were administered to 24 % ( 29 % GDT vs 20 % standard perioperative resuscitation ; p = 0.23 ) .
RESULTS	Mortality rate was 1 % ( 2 of 135 patients ; both in GDT ) .
RESULTS	On multivariable analysis , male sex , age , combined procedures , higher intraoperative fluid volume , and fluid boluses in the postanesthesia care unit were associated with higher 30-day morbidity .
CONCLUSIONS	Stroke volume variation-guided GDT is safe in patients undergoing liver resection and led to less intraoperative fluid .
CONCLUSIONS	Although the incidence of postoperative complications was similar in both arms , lower intraoperative resuscitation volume was independently associated with decreased postoperative morbidity in the entire cohort .
CONCLUSIONS	Future studies should target extensive resections and identify patients receiving large resuscitation volumes , as this population is more likely to benefit from this technique .

###24604819
BACKGROUND	Highly pathogenic avian influenza A ( H5N1 ) causes severe infections in humans .
BACKGROUND	We generated 2 influenza A ( H5N1 ) live attenuated influenza vaccines for pandemic use ( pLAIVs ) , but they failed to elicit a primary immune response .
BACKGROUND	Our objective was to determine whether the vaccines primed or established long-lasting immunity that could be detected by administration of inactivated subvirion influenza A ( H5N1 ) vaccine ( ISIV ) .
METHODS	The following groups were invited to participate in the study : persons who previously received influenza A ( H5N1 ) pLAIV ; persons who previously received an irrelevant influenza A ( H7N3 ) pLAIV ; and community members who were naive to influenza A ( H5N1 ) and LAIV .
METHODS	LAIV-experienced subjects received a single 45-g dose of influenza A ( H5N1 ) ISIV .
METHODS	Influenza A ( H5N1 ) - and LAIV-naive subjects received either 1 or 2 doses of ISIV .
RESULTS	In subjects who had previously received antigenically matched influenza A ( H5N1 ) pLAIV followed by 1 dose of ISIV compared with those who were naive to influenza A ( H5N1 ) and LAIV and received 2 doses of ISIV , we observed an increased frequency of antibody response ( 82 % vs 50 % , by the hemagglutination inhibition assay ) and a significantly higher antibody titer ( 112 vs 76 ; P = .04 ) .
RESULTS	The affinity of antibody and breadth of cross-clade neutralization was also enhanced in influenza A ( H5N1 ) pLAIV-primed subjects .
CONCLUSIONS	ISIV administration unmasked long-lasting immunity in influenza A ( H5N1 ) pLAIV recipients , with a rapid , high-titer , high-quality antibody response that was broadly cross-reactive across several influenza A ( H5N1 ) clades .
BACKGROUND	NCT01109329 .

###24922557
OBJECTIVE	The aim of this prospective clinical study was to derive the absolute and relative costs of cone beam CT ( CBCT ) and panoramic imaging before removal of an impacted mandibular third molar .
OBJECTIVE	Furthermore , the study aimed to analyse the influence of different cost-setting scenarios on the outcome of the absolute and relative costs and the incremental costs related to surgery .
METHODS	A randomized clinical trial compared complications following surgical removal of a mandibular third molar , where the pre-operative diagnostic method had been panoramic imaging or CBCT .
METHODS	The resources implied in the two methods were measured with health economic tools .
METHODS	The primary outcome was total costs defined as the sum of absolute imaging costs and incremental surgery-related costs .
METHODS	The basic variables were capital costs , operational costs , radiological costs , radiographic costs , overheads and patient resource utilization .
METHODS	Differences in resources used for surgical and post-surgical management were calculated for each patient .
RESULTS	Converted to monetary units , the total costs for panoramic imaging equalized 49.29 and for CBCT examination 184.44 .
RESULTS	Modifying effects on this outcome such as differences in surgery time , treatment time for complications , pre - and post-surgical medication , sickness absence , specialist treatment and hospitalization were not statistically significant between the two diagnostic method groups .
CONCLUSIONS	Costs for a CBCT examination were approximately four times the costs for panoramic imaging when used prior to removal of a mandibular third molar .
CONCLUSIONS	The use of CBCT did not change the resources used for surgery , post-surgical treatment and patient complication management .

###24727078
OBJECTIVE	Conducted a randomized controlled trial to investigate the effectiveness of cognitive behavioral therapy ( CBT ) , and compared the relative effectiveness of individual ( ICBT ) and group ( GCBT ) treatment approaches for anxiety disorders in children and adolescents .
METHODS	Referred youth ( N = 182 , M age = 11.5 years , range 8-15 years , 53 % girls ) with separation anxiety , social phobia , or generalized anxiety disorder were randomly assigned to ICBT , GCBT or a waitlist control ( WLC ) in community clinics .
METHODS	Pre - , post - , and one year follow-up assessments included youth and parent completed diagnostic interview and symptom measures .
METHODS	After comparing CBT ( ICBT and GCBT combined ) to WLC , ICBT and GCBT were compared along diagnostic recovery rates , clinically significant improvement , and symptom measures scores using traditional hypothesis tests , as well as statistical equivalence tests .
RESULTS	Significantly more youth lost all anxiety disorders after CBT compared to WLC .
RESULTS	Full diagnostic recovery rate was 25.3 % for ICBT and 20.5 % in GCBT , which was not significantly different .
RESULTS	There was continued lack of significant differences between ICBT and GCBT at one year follow-up .
RESULTS	However , equivalence between GCBT and ICBT could only be demonstrated for clinical severity rating of the principal anxiety disorder and child reported anxiety symptoms post-treatment .
CONCLUSIONS	Findings support the effectiveness of CBT compared to no intervention for youth with anxiety disorders , with no significant differences between ICBT and GCBT .
CONCLUSIONS	However , the relatively low recovery rates highlight the need for further improvement of CBT programs and their transportability from university to community settings .

###25587056
OBJECTIVE	To evaluate visual function and disease progression in the retinal structural abnormalities of three patients from two unrelated families with macular telangiectasia ( MacTel ) type 2 .
METHODS	Adaptive optics scanning laser ophthalmoscopy ( AOSLO ) and AOSLO microperimetry ( AOMP ) were used to evaluate the structure and function of macular cones in three eyes with MacTel type 2 .
METHODS	Cone spacing was estimated using histogram analysis of intercone distances , and registered spectral-domain optical coherence tomography ( SD-OCT ) scans were used to evaluate retinal anatomy .
METHODS	AOMP was used to assess visual sensitivity in and around areas of apparent cone loss .
RESULTS	Although overall lesion surface area increased , some initially affected regions subsequently showed clear , contiguous , and normally spaced cone mosaics with recovered photoreceptor inner/outer segment ( IS/OS ) reflectivity ( two of two eyes ) .
RESULTS	The AOMP test sites fell within three categories : normal-appearing cones ( N ) , dimly reflecting cones ( D ) , and RPE cell mosaics ( R ) .
RESULTS	At N sites , AOMP threshold values ( arbitrary units [ au ] ) increased with increasing eccentricity ( slope = 0.054 au/degree , r ( 2 ) = 0.77 ) .
RESULTS	The N thresholds ranged from 0.04 to 0.27 au , D thresholds from 0.04 to 0.33 au , and R thresholds from 0.14 to 1.00 au .
RESULTS	There was measurable visual sensitivity everywhere except areas without intact external limiting membrane ( ELM ) and with diffuse scattering in the IS/OS and posterior tips of the outer segments ( PTOS ) regions on OCT. .
CONCLUSIONS	Visual sensitivity and recovery of cone visibility in areas of apparent focal cone loss suggests that MacTel type 2 lesions with a preserved ELM may contain functioning cones with abnormal scattering and/or waveguiding characteristics .
CONCLUSIONS	( ClinicalTrials.gov number , NCT00254605 . )

###26061836
BACKGROUND	Cardiopulmonary resuscitation ( CPR ) performed by bystanders is associated with increased survival rates among persons with out-of-hospital cardiac arrest .
BACKGROUND	We investigated whether rates of bystander-initiated CPR could be increased with the use of a mobile-phone positioning system that could instantly locate mobile-phone users and dispatch lay volunteers who were trained in CPR to a patient nearby with out-of-hospital cardiac arrest .
METHODS	We conducted a blinded , randomized , controlled trial in Stockholm from April 2012 through December 2013 .
METHODS	A mobile-phone positioning system that was activated when ambulance , fire , and police services were dispatched was used to locate trained volunteers who were within 500 m of patients with out-of-hospital cardiac arrest ; volunteers were then dispatched to the patients ( the intervention group ) or not dispatched to them ( the control group ) .
METHODS	The primary outcome was bystander-initiated CPR before the arrival of ambulance , fire , and police services .
RESULTS	A total of 5989 lay volunteers who were trained in CPR were recruited initially , and overall 9828 were recruited during the study .
RESULTS	The mobile-phone positioning system was activated in 667 out-of-hospital cardiac arrests : 46 % ( 306 patients ) in the intervention group and 54 % ( 361 patients ) in the control group .
RESULTS	The rate of bystander-initiated CPR was 62 % ( 188 of 305 patients ) in the intervention group and 48 % ( 172 of 360 patients ) in the control group ( absolute difference for intervention vs. control , 14 percentage points ; 95 % confidence interval , 6 to 21 ; P < 0.001 ) .
CONCLUSIONS	A mobile-phone positioning system to dispatch lay volunteers who were trained in CPR was associated with significantly increased rates of bystander-initiated CPR among persons with out-of-hospital cardiac arrest .
CONCLUSIONS	( Funded by the Swedish Heart-Lung Foundation and Stockholm County ; ClinicalTrials.gov number , NCT01789554 . )

###24693626
OBJECTIVE	To evaluate the in vivo effect of chewing gum containing allyl isothiocyanate alone , and in combination with zinc salts on reduction of the level of volatile sulfur compounds responsible for oral malodor .
METHODS	15 healthy volunteers between the ages of 20-50 chewed either an experimental gum or a placebo gum for 12 minutes .
METHODS	Their mouth air was analyzed for volatile sulfur compounds by a gas chromatograph at baseline , immediately after chewing , and at 60 , 120 and 180 minutes after treatment .
RESULTS	The study revealed that allyl isothiocyanate , a constituent of mustard seed extract , can effectively reduce the concentration of volatile sulfur compounds in mouth air .
RESULTS	Chewing gum containing 0.1 % zinc lactate and 0.01 % of allyl isothiocyanate eliminated 89 % , 55.5 % , 48 % and 24 % of the total VSC concentration immediately after chewing and at 1 , 2 , and 3 hours after chewing , respectively .

###25041069
BACKGROUND	Recently , Marczinski and colleagues ( 2013 ) showed that energy drinks combined with alcohol augment a person 's desire to drink more alcohol relative to drinking alcohol alone .
BACKGROUND	The current study replicates the findings of Marczinski and colleagues ( 2013 ) using a robust measure of alcohol craving .
METHODS	Seventy-five participants aged 18 to 30years were assigned to an alcohol only or alcohol + energy drink condition in a double-blind randomized pre - versus posttest experiment .
METHODS	Participants received a cocktail containing either 60ml of vodka and a Red Bull ( ) Silver Edition energy drink ( alcohol + energy drink condition ) or 60ml of vodka with a soda water vehicle ( alcohol-only condition ) ; both cocktails contained 200ml of fruit drink .
METHODS	The primary outcome measure was the Alcohol Urge Questionnaire taken at pretest and at 20minutes ( posttest ) .
METHODS	Other measures taken at posttest were the Biphasic Alcohol Effects Questionnaire , the Drug Effects Questionnaire , and breath alcohol concentration ( BAC ) .
RESULTS	The alcohol + energy drink condition showed a greater pre - versus posttest increase in urge to drink alcohol compared with the alcohol-only condition ( B = 3.24 , p = 0.021 , d = 0.44 ) .
RESULTS	Participants in the alcohol + energy drink condition had significantly higher ratings on liking the cocktail and wanting to drink more of the cocktail , and lower BACs , than the alcohol-only condition .
RESULTS	When examined at specific BACs , the effect of the energy drink on the pre - to posttest increase in urge to drink was largest and only significant at BACs of 0.04-0 .05 ( cf. < 0.04 g/dl ) .
RESULTS	There were no significant differences in stimulation , sedation , feeling the effects of the cocktail , or feeling high .
CONCLUSIONS	Combining energy drinks with alcohol increased the urge to drink alcohol relative to drinking alcohol alone .
CONCLUSIONS	More research is needed to understand what factors mediate this effect and whether it increases subsequent alcohol consumption .

###24289892
OBJECTIVE	A significant correlation exists between coronary artery diseases and depression .
OBJECTIVE	The aim of this trial was to compare the efficacy and safety of saffron versus fluoxetine in improving depressive symptoms of patients who were suffering from depression after performing percutaneous coronary intervention ( PCI ) .
METHODS	In this randomized double-blind parallel-group study , 40 patients with a diagnosis of mild to moderate depression who had undergone PCI in the last six months were randomized to receive either fluoexetine ( 40mg/day ) or saffron ( 30mg/day ) capsule for six weeks .
METHODS	Participants were evaluated by Hamilton depression rating scale ( HDRS ) at weeks 3 and 6 and the adverse events were systemically recorded .
RESULTS	By the study endpoint , no significant difference was detected between two groups in reduction of HDRS scores ( P = 0.62 ) .
RESULTS	Remission and response rates were not significantly different as well ( P = 1.00 and P = 0.67 ; respectively ) .
RESULTS	There was no significant difference between two groups in the frequency of adverse events during this trial .
CONCLUSIONS	Relatively small sample size and short observational period were the major limitations of this study .
CONCLUSIONS	Short-term therapy with saffron capsules showed the same antidepressant efficacy compared with fluoxetine in patients with a prior history of PCI who were suffering from depression .

###24369076
BACKGROUND	Arthroscopic partial meniscectomy is one of the most common orthopedic procedures , yet rigorous evidence of its efficacy is lacking .
METHODS	We conducted a multicenter , randomized , double-blind , sham-controlled trial in 146 patients 35 to 65 years of age who had knee symptoms consistent with a degenerative medial meniscus tear and no knee osteoarthritis .
METHODS	Patients were randomly assigned to arthroscopic partial meniscectomy or sham surgery .
METHODS	The primary outcomes were changes in the Lysholm and Western Ontario Meniscal Evaluation Tool ( WOMET ) scores ( each ranging from 0 to 100 , with lower scores indicating more severe symptoms ) and in knee pain after exercise ( rated on a scale from 0 to 10 , with 0 denoting no pain ) at 12 months after the procedure .
RESULTS	In the intention-to-treat analysis , there were no significant between-group differences in the change from baseline to 12 months in any primary outcome .
RESULTS	The mean changes ( improvements ) in the primary outcome measures were as follows : Lysholm score , 21.7 points in the partial-meniscectomy group as compared with 23.3 points in the sham-surgery group ( between-group difference , -1.6 points ; 95 % confidence interval [ CI ] , -7.2 to 4.0 ) ; WOMET score , 24.6 and 27.1 points , respectively ( between-group difference , -2.5 points ; 95 % CI , -9.2 to 4.1 ) ; and score for knee pain after exercise , 3.1 and 3.3 points , respectively ( between-group difference , -0.1 ; 95 % CI , -0.9 to 0.7 ) .
RESULTS	There were no significant differences between groups in the number of patients who required subsequent knee surgery ( two in the partial-meniscectomy group and five in the sham-surgery group ) or serious adverse events ( one and zero , respectively ) .
CONCLUSIONS	In this trial involving patients without knee osteoarthritis but with symptoms of a degenerative medial meniscus tear , the outcomes after arthroscopic partial meniscectomy were no better than those after a sham surgical procedure .
CONCLUSIONS	( Funded by the Sigrid Juselius Foundation and others ; ClinicalTrials.gov number , NCT00549172 . )

###24260254
BACKGROUND	Placebo effects have been reported in type I allergic reactions .
BACKGROUND	However the neuropsychological mechanisms steering placebo responses in allergies are largely unknown .
BACKGROUND	The study analyzed whether and to what extend a conditioned placebo response is affecting type I allergic reactions and whether this response can be reproduced at multiple occasions .
METHODS	62 patients with house dust mite allergy were randomly allocated to either a conditioned ( n = 25 ) , sham-conditioned ( n = 25 ) or natural history ( n = 12 ) group .
METHODS	During the learning phase ( acquisition ) , patients in the conditioned group received the H1-receptor antagonist desloratadine ( 5mg ) ( unconditioned stimulus/US ) together with a novel tasting gustatory stimulus ( conditioned stimulus/CS ) .
METHODS	Patients in the sham-conditioned control group received the CS together with a placebo pill .
METHODS	After a wash out time of 9 days patients in the conditioned and sham-conditioned group received placebo pills together with the CS during evocation .
METHODS	Allergic responses documented by wheal size after skin prick test and symptom scores after nasal provocation were analyzed at baseline , after last desloratadine treatment and after the 1 ( st ) and 5 ( th ) CS re-exposure .
RESULTS	Both conditioned and sham-conditioned patients showed significantly decreased wheal sizes after the 1 ( st ) CS-evocation and significantly decreased symptom scores after the 1 ( st ) as well as after the 5 ( th ) evocation compared to the natural history control group .
CONCLUSIONS	These results indicate that placebo responses in type I allergy are not primarily mediated by learning processes , but seemed to be induced by cognitive factors such as patients ' expectation , with these effects not restricted to a single evocation .

###24588368
BACKGROUND	Frequent skin cleaning fulfils the definition of occupational ` wet work ' .
BACKGROUND	Standardized methods are required to assess the irritation potential of workplace cleansers .
OBJECTIVE	To develop a standardized procedure for testing the irritation potential of occupational skin cleansers .
METHODS	In this single-blind , single-centre trial in 25 healthy volunteers , the irritation potential of five generic reference cleansers was tested by three-times-daily washing with an automated skin cleaning device for 4days , and quantification of cumulative skin barrier damage was performed by visual scoring , chromametry , transepidermal water loss TEWL , and corneometry .
METHODS	For two cleansers , reproducibility of the irritancy assessment was assessed .
METHODS	Furthermore , the irritation induced by four commercial workplace skin cleansers was studied .
RESULTS	Whereas no significant changes were observed for any of the tested cleansers by either visual scoring or chromametry , significant increases in TEWL and significant decreases in stratum corneum hydration were found for all cleansers .
RESULTS	Cleansers differed significantly in their irritation potential .
RESULTS	On retesting of two cleansers , the first results were confirmed .
RESULTS	Among the four commercial cleansers , one that was claimed to be mild was found to be disproportionally irritant .
CONCLUSIONS	The presented model for testing cleansing preparations allows a highly controlled , practically relevant and reproducible irritancy assessment of occupational skin cleansers .

###24886701
OBJECTIVE	The effects of brimonidine on daytime and nighttime intraocular pressure ( IOP ) and aqueous humor dynamics were evaluated in volunteers with ocular hypertension ( OHT ) .
METHODS	Thirty participants with OHT ( 58.61.7 years old , meanSEM ) were enrolled into this randomized , double-masked , cross-over study .
METHODS	For 6 weeks , participants self-administered 0.2 % brimonidine or placebo 3 times daily .
METHODS	During daytime and nighttime visits , measurements included aqueous flow ( Fa ) by fluorophotometry , outflow facility ( C ) by tonography , episcleral venous pressure ( Pev ) by venomanometry , and seated and supine IOP by pneumatonometry .
METHODS	Uveoscleral outflow ( U ) was calculated mathematically .
RESULTS	When treated with placebo , nighttime supine Pev ( 11.20.25 mm Hg ) was higher ( P < 0.05 ) compared with daytime seated Pev ( 10.20.25 mm Hg ) , and Fa and U were significantly reduced at night .
RESULTS	Brimonidine significantly lowered seated IOP at 9:00 AM and 11:00 AM , 9:00 PM and 11:00 PM and supine IOP at 9:00 AM and 11:00 AM .
RESULTS	Brimonidine increased U at 9 AM and 11 AM ( P < 0.01 ) and had no effect on daytime and nighttime Fa , C , or Pev .
CONCLUSIONS	In subjects with OHT , brimonidine treatment for 6 weeks significantly reduces seated IOP during the day by increasing uveoscleral outflow .
CONCLUSIONS	The lack of IOP effect at night can be explained by failure to overcome a normal nighttime reduction of uveoscleral outflow .

###24831862
BACKGROUND	Pain is a negative factor in the recovery process of postoperative patients .
BACKGROUND	It causes pulmonary alterations and complications , and it also affects functional capacity .
BACKGROUND	Several studies have investigated the effects of transcutaneous electrical nerve stimulation ( TENS ) during the postoperative period .
BACKGROUND	However , no studies have assessed the effects of TENS on kidney donors .
BACKGROUND	Thus , the aim of the present study was to evaluate the effect of TENS on pain , walking function , respiratory muscle strength and vital capacity in kidney donors .
METHODS	Seventy-four patients were randomly allocated into two groups : active TENS or placebo TENS .
METHODS	All patients were assessed for pain intensity , respiratory muscle strength , vital capacity and walking function before and after the TENS application on the first day of the postoperative period .
RESULTS	The use of active TENS significantly reduced pain at rest ( p = 0.006 ) , during the measurement of maximal inspiratory pressure ( p = 0.006 ) , during maximal expiratory pressure ( p = 0.004 ) and during vital capacity ( p = 0.013 ) .
RESULTS	Active TENS also produced a significant increase in maximal expiratory pressure when compared with the placebo TENS group ( p = 0.001 ) .
RESULTS	Maximal inspiratory pressure , vital capacity and walking function were not significantly different between the two treatment groups .
CONCLUSIONS	These results suggest that TENS decreases pain intensity at rest and during respiratory manoeuvres and increases maximal expiratory pressure during the postoperative period in kidney donors after open nephrectomy .

###24912589
OBJECTIVE	To investigate the effect of systematic screening for risk factors for ischaemic heart disease followed by repeated lifestyle counselling on the 10 year development of ischaemic heart disease at a population level .
METHODS	Randomised controlled community based trial .
METHODS	Suburbs of Copenhagen , Denmark .
METHODS	59,616 people aged 30-60 years randomised with different age and sex randomisation ratios to an intervention group ( n = 11,629 ) and a control group ( n = 47,987 ) .
METHODS	The intervention group was invited for screening , risk assessment , and lifestyle counselling up to four times over a five year period .
METHODS	All participants with an unhealthy lifestyle had individually tailored lifestyle counselling at all visits ( at baseline and after one and three years ) ; those at high risk of ischaemic heart disease , according to predefined criteria , were furthermore offered six sessions of group based lifestyle counselling on smoking cessation , diet , and physical activity .
METHODS	After five years all were invited for a final counselling session .
METHODS	Participants were referred to their general practitioner for medical treatment , if relevant .
METHODS	The control group was not invited for screening .
METHODS	The primary outcome measure was incidence of ischaemic heart disease in the intervention group compared with the control group .
METHODS	Secondary outcome measures were stroke , combined events ( ischaemic heart disease , stroke , or both ) , and mortality .
RESULTS	6091 ( 52.4 % ) people in the intervention group participated at baseline .
RESULTS	Among 5978 people eligible at five year follow-up ( 59 died and 54 emigrated ) , 4028 ( 67.4 % ) attended .
RESULTS	A total of 3163 people died in the 10 year follow-up period .
RESULTS	Among 58,308 without a history of ischaemic heart disease at baseline , 2782 developed ischaemic heart disease .
RESULTS	Among 58,940 without a history of stroke at baseline , 1726 developed stroke .
RESULTS	No significant difference was seen between the intervention and control groups in the primary end point ( hazard ratio for ischaemic heart disease 1.03 , 95 % confidence interval 0.94 to 1.13 ) or in the secondary endpoints ( stroke 0.98 , 0.87 to 1.11 ; combined endpoint 1.01 , 0.93 to 1.09 ; total mortality 1.00 , 0.91 to 1.09 ) .
CONCLUSIONS	A community based , individually tailored intervention programme with screening for risk of ischaemic heart disease and repeated lifestyle intervention over five years had no effect on ischaemic heart disease , stroke , or mortality at the population level after 10 years.Trial registration Clinical trials NCT00289237 .

###25175668
OBJECTIVE	Even small design modifications of uncemented hip stems may alter the postoperative 3-D migration pattern .
OBJECTIVE	The Furlong Active is an uncemented femoral stem which , in terms of design , is based on its precursor-the well-proven Furlong HAC-but has undergone several design changes .
OBJECTIVE	The collar has been removed on the Active stem along with the lateral fin ; it is shorter and has more rounded edges in the proximal part .
OBJECTIVE	We compared the migration patterns of the uncemented Furlong HAC stem and the modified Furlong Active stem in a randomized , controlled trial over 5 years using radiostereometry ( RSA ) .
METHODS	50 patients with primary osteoarthritis were randomized to receive either the HAC stem or the Active stem .
METHODS	The patients underwent repeated RSA examinations ( postoperatively , at 3 months , and after 1 , 2 , and 5 years ) and conventional radiography , and they also filled out hip-specific questionnaires .
RESULTS	During the first 3 months , the collarless Active stem subsided to a greater extent than the collar-fitted HAC stem ( 0.99 mm vs. 0.31 mm , p = 0.05 ) .
RESULTS	There were , however , no other differences in movement measured by RSA or in clinical outcome between the 2 stems .
RESULTS	After 3 months , both stem types had stabilized and almost no further migration was seen .
CONCLUSIONS	The Active stem showed no signs of unfavorable migration .
CONCLUSIONS	Our results suggest that the osseointegration is not compromised by the new design features .

###24237806
BACKGROUND	The prone maximal restraint ( PMR ) position has been used by law enforcement and emergency care personnel to restrain acutely combative or agitated individual .
BACKGROUND	The position places the subject prone with wrists handcuffed behind the back and secured to the ankles .
BACKGROUND	Prior work has indicated a reduction in inferior vena cava ( IVC ) diameter associated with this position when weight force is applied to the back .
BACKGROUND	It is therefore possible that this position can negatively impact hemodynamic stability .
OBJECTIVE	We sought to measure the impact of PMR with and without weight force on measures of cardiac function including vital signs , oxygenation , stroke volume ( SV ) , IVC diameter , cardiac output ( CO ) and cardiac index ( CI ) .
METHODS	We conducted a randomized prospective cross-over experimental study of 25 healthy male volunteers ( 22-43 years of age ) placed in 5 different body positions : supine ( SU ) , prone ( PR ) , prone maximal restraint with no weight force ( PMR-0 ) , prone maximal restraint with 50lbs added to the subject 's back ( PMR-50 ) , and prone maximal restraint with 100lbs added to the subject 's back ( PMR-100 ) for 3min .
METHODS	Heart rate ( HR ) , blood pressure ( BP ) , and oxygenation saturation ( O2 sat ) were monitored .
METHODS	In addition , echocardiography was performed to measure left ventricular outflow tract diameter ( LVOTD ) , and SV , CO , and CI were then calculated .
METHODS	Data were analyzed using repeated measures ANOVA with pair-wise comparisons when appropriate to evaluate changes with each variable with respective positioning .
RESULTS	Despite a small decrease in SV between SU and PMR positions , there were no statistically significant differences in CO between the 5 different positions .
RESULTS	There were also no differences in CI between positions other than a small decrease when comparing SU and PMR-50 only ( mean difference-0 .39 L/stroke , p = 0.005 ) .
RESULTS	There was no evidence of hemodynamic compromise in any of the PMR positions when evaluating HR , MAP or O2 sat .
CONCLUSIONS	PMR with and without weight force did not result in any changes in CO or other evidence of cardiovascular or hemodynamic compromise .

###24665827
BACKGROUND	Platelet factor 4/heparin ( PF4/H ) antibody detection is widely used to evaluate the risk of thrombosis in patients undergoing hemodialysis ( HD ) .
BACKGROUND	Most patients who are PF4/H-antibody-positive can survive thrombosis , but the reason has not been clarified .
BACKGROUND	In addition , no valid preventive methods for thrombosis in patients undergoing HD have been confirmed .
METHODS	A single-center , semi-randomized controlled study was designed .
METHODS	In total , 157 patients fulfilled the inclusion criteria and participated .
METHODS	Patients were first divided according to PF4/H antibody detection and then subdivided randomly according to different anti-platelet agent descriptions .
RESULTS	( 1 ) PF4/H antibody-positive patients suffered a significantly higher incidence of thrombosis than those who were antibody-negative ; ( 2 ) PF4/H antibody-positive patients who survived a thrombosis manifested a significantly longer bleeding time and decreased maximum percentage of platelet aggregation inhibition ; ( 3 ) aspirin and clopidogrel decreased the incidence of thrombosis in PF4/H antibody-positive patients by inhibiting platelet activation .
CONCLUSIONS	The PF4/H antibody was effective for prediction of the risk of thrombosis , except in patients with dysfunctional platelets ; aspirin manifested effects similar to clopidogrel in terms of prevention of thromboses in PF4/H antibody-positive patients , but costs much less and is therefore recommended .

###24597974
OBJECTIVE	Women with gestational diabetes are at high risk for developing diabetes ; post-partum weight loss may reduce the risk of diabetes .
OBJECTIVE	We evaluated the association of post-partum weight change with changes in glucose , insulin and homeostasis model assessment of insulin resistance in a subsample ( n = 72 ) of participants from Diet Exercise and Breastfeeding Intervention ( DEBI ) , a randomized pilot trial of lifestyle intervention for women with gestational diabetes .
METHODS	Glucose and insulin were measured fasting and 2h after an oral glucose tolerance test at 6weeks and 12months post-partum .
METHODS	Women were categorized by weight change ( lost > 2kg vs. maintained/gained ) between 6weeks and 12months post-partum .
RESULTS	Compared with women who maintained or gained weight , women who lost > 2kg experienced significantly lower increases in fasting glucose [ age-adjusted means : 0.1 mmol/l ( 95 % CI -0.03 to 0.3 ) vs. 0.4 mmol/l ( 95 % CI 0.3-0 .6 ) ; P < 0.01 ] and 2-h insulin [ 10.0 pmol/l ( 95 % CI -56.9 to 76.9 ) vs. 181.2 pmol/l ( 95 % CI 108.3-506 .9 ) ; P < 0.01 ] and a significant reduction in 2-h glucose [ -0.9 mmol/l ( 95 % CI -1.4 to -0.3 ) vs. 0.3 mmol/l ( 95 % CI -0.3 to 0.9 ) ; P < 0.01 ] .
RESULTS	In multiple linear regression models adjusted for age , Hispanic ethnicity , medication use , meeting the Institute of Medicine 's recommendations for gestational weight gain , breastfeeding and randomized group , a 1-kg increase in weight was significantly associated with increases in fasting and 2-h glucose ( P < 0.05 ) , but was not associated with insulin or homeostasis model assessment of insulin resistance .
CONCLUSIONS	In women with gestational diabetes , modest post-partum weight loss may be associated with improvements in glucose metabolism .

###24601169
BACKGROUND	Because of the increasing resistance to clarithromycin and metronidazole , new therapeutic alternatives are needed .
BACKGROUND	The purpose of this study was to compare the efficacy of 7 - and 10-day triple therapy including omeprazole , levofloxacin and amoxicilline for Helicobacter pylori eradication as a first-line therapy .
METHODS	One hundred and five patients with peptic ulcer disease and with non-ulcer dyspepsia infected with Helicobacter pylori were included in this study .
METHODS	Patients were randomized to receive either 7-day or 10-day therapy with omeprazole ( 20 mg b.i.d. ) , plus levofloxacin ( 500 mg o.i.d. ) and amoxicilline ( 1000 mg b.i.d. ) .
METHODS	Eradication was assessed by negative histological analyses , negative H. pylori stool antigen or rapid urease test .
RESULTS	In Group 1 , the eradication rate was 86 , 2 % , while in group 2 , eradication rate was 93,6 % .
RESULTS	There was no difference between groups ( p = 0.218 ) .
RESULTS	Adverse effects were reported in 5 , 25 % of the patients , including nausea and diarrhea .
CONCLUSIONS	The levofloxacin-based regimen can be one effective therapy for the first-line anti-H .
CONCLUSIONS	pylori treatment .
CONCLUSIONS	However , a levofloxacin-based triple therapy is not generally recommended as first-line therapy at the moment due to concerns about the rising prevalence of quinolone-resistant strains in the first-line and second-line anti-H .
CONCLUSIONS	pylori therapies .

###25875257
BACKGROUND	Aerosolized vaccine can be used as a needle-free method of immunization against measles , a disease that remains a major cause of illness and death .
BACKGROUND	Data on the immunogenicity of aerosolized vaccine against measles in children are inconsistent .
METHODS	We conducted an open-label noninferiority trial involving children 9.0 to 11.9 months of age in India who were eligible to receive a first dose of measles vaccine .
METHODS	Children were randomly assigned to receive a single dose of vaccine by means of either aerosol inhalation or a subcutaneous injection .
METHODS	The primary end points were seropositivity for antibodies against measles and adverse events 91 days after vaccination .
METHODS	The noninferiority margin was 5 percentage points .
RESULTS	A total of 1001 children were assigned to receive aerosolized vaccine , and 1003 children were assigned to receive subcutaneous vaccine ; 1956 of all the children ( 97.6 % ) were followed to day 91 , but outcome data were missing for 331 children because of thawed specimens .
RESULTS	In the per-protocol population , data on 1560 of 2004 children ( 77.8 % ) could be evaluated .
RESULTS	At day 91 , a total of 662 of 775 children ( 85.4 % ; 95 % confidence interval [ CI ] , 82.5 to 88.0 ) in the aerosol group , as compared with 743 of 785 children ( 94.6 % ; 95 % CI , 92.7 to 96.1 ) in the subcutaneous group , were seropositive , a difference of -9.2 percentage points ( 95 % CI , -12.2 to -6.3 ) .
RESULTS	Findings were similar in the full-analysis set ( 673 of 788 children in the aerosol group [ 85.4 % ] and 754 of 796 children in the subcutaneous group [ 94.7 % ] were seropositive at day 91 , a difference of -9.3 percentage points [ 95 % CI , -12.3 to -6.4 ] ) and after multiple imputation of missing results .
RESULTS	No serious adverse events were attributable to measles vaccination .
RESULTS	Adverse-event profiles were similar in the two groups .
CONCLUSIONS	Aerosolized vaccine against measles was immunogenic , but , at the prespecified margin , the aerosolized vaccine was inferior to the subcutaneous vaccine with respect to the rate of seropositivity .
CONCLUSIONS	( Funded by the Bill and Melinda Gates Foundation ; Measles Aerosol Vaccine Project Clinical Trials Registry-India number , CTRI/2009/091 / 000673 . )

###24922484
OBJECTIVE	To compare clinical and process outcomes of cognitive processing therapy-cognitive only version ( CPT-C ) delivered via videoteleconferencing ( VTC ) to in-person in a rural , ethnically diverse sample of veterans with posttraumatic stress disorder ( PTSD ) .
METHODS	A randomized clinical trial with a noninferiority design was used to determine if providing CPT-C via VTC is effective and `` as good as '' in-person delivery .
METHODS	The study took place between March 2009 and June 2013 .
METHODS	PTSD was diagnosed per DSM-IV .
METHODS	Participants received 12 sessions of CPT-C via VTC ( n = 61 ) or in-person ( n = 64 ) .
METHODS	Assessments were administered at baseline , midtreatment , immediately posttreatment , and 3 and 6 months posttreatment .
METHODS	The primary clinical outcome was posttreatment PTSD severity , as measured by the Clinician-Administered PTSD Scale .
RESULTS	Clinical and process outcomes found VTC to be noninferior to in-person treatment .
RESULTS	Significant reductions in PTSD symptoms were identified at posttreatment ( Cohen d = 0.78 , P < .05 ) and maintained at 3 - and 6-month follow-up ( d = 0.73 , P < .05 and d = 0.76 , P < .05 , respectively ) .
RESULTS	High levels of therapeutic alliance , treatment compliance , and satisfaction and moderate levels of treatment expectancies were reported , with no differences between groups ( for all comparisons , F < 1.9 , P > .17 ) .
CONCLUSIONS	Providing CPT-C to rural residents with PTSD via VTC produced outcomes that were `` as good as '' in-person treatment .
CONCLUSIONS	All participants demonstrated significant reductions in PTSD symptoms posttreatment and at follow-up .
CONCLUSIONS	Results indicate that VTC can offer increased access to specialty mental health care for residents of rural or remote areas .
BACKGROUND	ClinicalTrials.gov identifier : NCT00879255 .

###25795076
BACKGROUND	New antituberculosis regimens are urgently needed to shorten tuberculosis treatment .
BACKGROUND	Following on from favourable assessment in a 2 week study , we investigated a novel regimen for efficacy and safety in drug-susceptible and multidrug-resistant ( MDR ) tuberculosis during the first 8 weeks of treatment .
METHODS	We did this phase 2b study of bactericidal activity -- defined as the decrease in colony forming units ( CFUs ) of Mycobacterium tuberculosis in the sputum of patients with microscopy smear-positive pulmonary tuberculosis-at eight sites in South Africa and Tanzania .
METHODS	We enrolled treatment-naive patients with drug-susceptible , pulmonary tuberculosis , who were randomly assigned by computer-generated sequences to receive either 8 weeks of moxifloxacin , 100 mg pretomanid ( formerly known as PA-824 ) , and pyrazinamide ( MPa100Z regimen ) ; moxifloxacin , 200 mg pretomanid , and pyrazinamide ( MPa200Z regimen ) ; or the current standard care for drug-susceptible pulmonary tuberculosis , isoniazid , rifampicin , PZA , and ethambutol ( HRZE regimen ) .
METHODS	A group of patients with MDR tuberculosis received MPa200Z ( DRMPa200Z group ) .
METHODS	The primary outcome was bactericidal activity measured by the mean daily rate of reduction in M tuberculosis CFUs per mL overnight sputum collected once a week , with joint Bayesian non-linear mixed-effects regression modelling .
METHODS	We also assessed safety and tolerability by monitoring adverse events .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01498419 .
RESULTS	Between March 24 , 2012 , and July 26 , 2013 we enrolled 207 patients and randomly assigned them to treatment groups ; we assigned 60 patients to the MPa100Z regimen , 62 to the MPa200Z regimen , and 59 to the HRZE regimen .
RESULTS	We non-randomly assigned 26 patients with drug-resistant tuberculosis to the DRMPa200Z regimen .
RESULTS	In patients with drug-susceptible tuberculosis , the bactericidal activity of MPa200Z ( n = 54 ) on days 0-56 ( 0155 , 95 % Bayesian credibility interval 0133-0178 ) was significantly greater than for HRZE ( n = 54 , 0112 , 0093-0131 ) .
RESULTS	DRMPa200Z ( n = 9 ) had bactericidal activity of 0117 ( 0070-0174 ) .
RESULTS	The bactericidal activity on days 7-14 was strongly associated with bactericidal activity on days 7-56 .
RESULTS	Frequencies of adverse events were similar to standard treatment in all groups .
RESULTS	The most common adverse event was hyperuricaemia in 59 ( 29 % ) patients ( 17 [ 28 % ] patients in MPa100Z group , 17 [ 27 % ] patients in MPa200Z group , 17 [ 29 % ] patients .
RESULTS	in HRZE group , and 8 [ 31 % ] patients in DRMPa200Z group ) .
RESULTS	Other common adverse events were nausea in ( 14 [ 23 % ] patients in MPa100Z group , 8 [ 13 % ] patients in MPa200Z group , 7 [ 12 % ] patients in HRZE group , and 8 [ 31 % ] patients in DRMPa200Z group ) and vomiting ( 7 [ 12 % ] patients in MPa100Z group , 7 [ 11 % ] patients in MPa200Z group , 7 [ 12 % ] patients in HRZE group , and 4 [ 15 % ] patients in DRMPa200Z group ) .
RESULTS	No on-treatment electrocardiogram occurrences of corrected QT interval more than 500 ms ( an indicator of potential of ventricular tachyarrhythmia ) were reported .
RESULTS	No phenotypic resistance developed to any of the drugs in the regimen .
CONCLUSIONS	The combination of moxifloxacin , pretomanid , and pyrazinamide , was safe , well tolerated , and showed superior bactericidal activity in drug-susceptible tuberculosis during 8 weeks of treatment .
CONCLUSIONS	Results were consistent between drug-susceptible and MDR tuberculosis .
CONCLUSIONS	This new regimen is ready to enter phase 3 trials in patients with drug-susceptible tuberculosis and MDR-tuberculosis , with the goal of shortening and simplifying treatment .
BACKGROUND	Global Alliance for TB Drug Development .

###24681717
BACKGROUND	Little is known about the factors that influence acceptability of and adherence to online psychological interventions .
BACKGROUND	Evidence is needed to guide further development of promising programs .
OBJECTIVE	Our goal was to investigate users ' views of two online approaches to self-help for depression : computerized cognitive behavior therapy ( cCBT ) and informational websites , in a workplace context .
OBJECTIVE	Computerized CBT offers an inexpensive and accessible alternative to face-to-face therapy , and employers have an interest in reducing the working time lost to depression or stress .
OBJECTIVE	Yet little is known about how employees , who have actual experience of using online approaches , judge the intervention as a process .
METHODS	The qualitative data reported here were collected within an online randomized controlled trial whose participants had diagnosable depression .
METHODS	The experimental intervention was a 5-week cCBT program called MoodGYM , and the control condition was five informational websites about mental health .
METHODS	Data were collected via online questionnaires .
METHODS	There was no evidence of the superiority of either in terms of treatment outcomes .
METHODS	In parallel , using brief rating scales and open-ended questions designed for this purpose , we examined the relative acceptability of each approach over time , including perceptions of cCBT compared to seeing a health care professional .
RESULTS	At least 60 % of participants held online therapy to be at least as acceptable as seeing a professional about mental health issues , and they were more likely to retain this opinion over time if they used the interactive program , MoodGYM , rather than informational websites alone .
RESULTS	Barriers to cCBT use fell into four categories : intrinsic , intrapersonal problems ; extrinsic technical problems ; generic issues mostly pertaining to perceptions of cCBT ; and specific issues about the intervention or control condition .
RESULTS	These indicate strategies for improving engagement .
CONCLUSIONS	As first-aid for mild to moderate mental health problems , evidence-based computerized approaches have broad acceptability .
CONCLUSIONS	This could be increased by attending to the barriers noted here and by proactively managing users ' expectations at individual and organizational levels .
CONCLUSIONS	The findings have implications for occupational health providers and others addressing the needs of working-age adults with depression .
CONCLUSIONS	They also raise methodological issues for online research .
BACKGROUND	International Standard Randomized Controlled Trial Number ( ISRCTN ) : 24529487 ; http://www.controlled-trials.com/ISRCTN24529487 ( Archived by Webcite at http://www.webcitation.org/6O8cCL4mh ) .

###24491075
OBJECTIVE	Opioid pharmacotherapy is now the leading treatment for chronic pain , a problem that affects nearly one third of the U.S. population .
OBJECTIVE	Given the dramatic rise in prescription opioid misuse and opioid-related mortality , novel behavioral interventions are needed .
OBJECTIVE	The purpose of this study was to conduct an early-stage randomized controlled trial of Mindfulness-Oriented Recovery Enhancement ( MORE ) , a multimodal intervention designed to simultaneously target mechanisms underpinning chronic pain and opioid misuse .
METHODS	Chronic pain patients ( N = 115 ; mean age = 48 14 years ; 68 % female ) were randomized to 8 weeks of MORE or a support group ( SG ) .
METHODS	Outcomes were measured at pre - and posttreatment , and at 3-month follow-up .
METHODS	The Brief Pain Inventory was used to assess changes in pain severity and interference .
METHODS	Changes in opioid use disorder status were measured by the Current Opioid Misuse Measure .
METHODS	Desire for opioids , stress , nonreactivity , reinterpretation of pain sensations , and reappraisal were also evaluated .
RESULTS	MORE participants reported significantly greater reductions in pain severity ( p = .038 ) and interference ( p = .003 ) than SG participants , which were maintained by 3-month follow-up and mediated by increased nonreactivity and reinterpretation of pain sensations .
RESULTS	Compared with SG participants , participants in MORE evidenced significantly less stress arousal ( p = .034 ) and desire for opioids ( p = .027 ) , and were significantly more likely to no longer meet criteria for opioid use disorder immediately following treatment ( p = .05 ) ; however , these effects were not sustained at follow-up .
CONCLUSIONS	Findings demonstrate preliminary feasibility and efficacy of MORE as a treatment for co-occurring prescription opioid misuse and chronic pain .
CONCLUSIONS	( PsycINFO Database Record ( c ) 2014 APA , all rights reserved ) .

###24905068
BACKGROUND	Glycemic control improves with physical activity , but the optimal exercise mode is unknown .
OBJECTIVE	The objective of the study was to determine whether interval-based exercise improves postprandial glucose tolerance and free-living glycemia more than oxygen consumption - and time duration-matched continuous exercise .
METHODS	This was a crossover , controlled study with trials performed in randomized order .
METHODS	The study was conducted in hospitalized and ambulatory care .
METHODS	PATIENTS diagnosed with type 2 diabetes mellitus ( n = 10 , no withdrawals ) participated in the study .
METHODS	Subjects performed three 1-hour interventions : 1 ) interval walking ( IW ; repeated cycles of 3 min of slow and fast walking ) ; 2 ) continuous walking ( CW ) ; and 3 ) control ( CON ) .
METHODS	Oxygen consumption ( VO2 ) was measured continuously to match mean VO2 between exercise sessions ( 75 % VO2peak ) .
METHODS	A mixed-meal tolerance test ( MMTT ; 450 kcal , 55 % carbohydrate ) with stable glucose isotopic tracers was provided after each intervention , and glucose kinetics were measured during the following 4 hours .
METHODS	Free-living glycemic control was assessed for approximately 32 hours after the MMTT using continuous glucose monitoring .
RESULTS	VO2 was well matched between the exercise interventions .
RESULTS	IW decreased the mean and maximal incremental plasma glucose during the MMTT when compared with the CON ( mean 1.2 0.4 vs 2.0 0.5 mmol/L , P < .001 ; maximal 3.7 0.6 vs 4.6 0.7 mmol/L , P = .005 ) and mean when compared with CW ( 1.7 0.4 mmol/L , P = .02 ) .
RESULTS	No differences in the mean or maximal incremental plasma glucose values were seen between the CW and CON .
RESULTS	The metabolic clearance rate of glucose during the MMTT was increased in the IW compared with CW ( P = .049 ) and CON ( P < .001 ) .
RESULTS	Continuous glucose monitoring mean glucose was reduced in IW compared with CW for the rest of the intervention day ( 8.2 0.4 vs 9.3 0.7 mmol/L , P = .03 ) , whereas no differences were found between IW and CW the following day .
CONCLUSIONS	One interval-based exercise session improves glycemic control in type 2 diabetes mellitus subjects when compared with an oxygen consumption - and time duration-matched continuous exercise session .

###24984771
OBJECTIVE	To determine if a computer-based simulation with haptic technology can help surgical trainees improve tactile discrimination using surgical instruments .
METHODS	Twenty junior medical students participated in the study and were randomized into two groups .
METHODS	Subjects in Group A participated in virtual simulation training using the ImmersiveTouch simulator ( ImmersiveTouch , Inc. , Chicago , IL , USA ) that required differentiating the firmness of virtual spheres using tactile and kinesthetic sensation via haptic technology .
METHODS	Subjects in Group B did not undergo any training .
METHODS	With their visual fields obscured , subjects in both groups were then evaluated on their ability to use the suction and bipolar instruments to find six elastothane objects with areas ranging from 1.5 to 3.5 cm2 embedded in a urethane foam brain cavity model while relying on tactile and kinesthetic sensation only .
RESULTS	A total of 73.3 % of the subjects in Group A ( simulation training ) were able to find the brain cavity objects in comparison to 53.3 % of the subjects in Group B ( no training ) ( P = 0.0183 ) .
RESULTS	There was a statistically significant difference in the total number of Group A subjects able to find smaller brain cavity objects ( size 2.5 cm2 ) compared to that in Group B ( 72.5 vs. 40 % , P = 0.0032 ) .
RESULTS	On the other hand , no significant difference in the number of subjects able to detect larger objects ( size 3 cm2 ) was found between Groups A and B ( 75 vs. 80 % , P = 0.7747 ) .
CONCLUSIONS	Virtual computer-based simulators with integrated haptic technology may improve tactile discrimination required for microsurgical technique .

###24505290
BACKGROUND	Inhaled corticosteroids ( ICS ) reduce exacerbation rates and improve health status but can increase the risk of pneumonia in COPD .
BACKGROUND	The GLUCOLD study , investigating patients with mild-to-moderate COPD , has shown that long-term ( 2.5-year ) ICS therapy induces anti-inflammatory effects .
BACKGROUND	The literature suggests that cigarette smoking causes ICS insensitivity .
BACKGROUND	The aim of this study is to compare anti-inflammatory effects of ICS in persistent smokers and persistent ex-smokers in a post-hoc analysis of the GLUCOLD study .
METHODS	Persistent smokers ( n = 41 ) and persistent ex-smokers ( n = 31 ) from the GLUCOLD cohort were investigated .
METHODS	Effects of ICS treatment compared with placebo were estimated by analysing changes in lung function , hyperresponsiveness , and inflammatory cells in sputum and bronchial biopsies during short-term ( 0-6 months ) and long-term ( 6-30 months ) treatment using multiple regression analyses .
RESULTS	Bronchial mast cells were reduced by short-term and long-term ICS treatment in both smokers and ex-smokers .
RESULTS	In contrast , CD3 , CD4 , and CD8 cells were reduced by short-term ICS treatment in smokers only .
RESULTS	In addition , sputum neutrophils and lymphocytes , and bronchial CD8 cells were reduced after long-term treatment in ex-smokers only .
RESULTS	No significant interactions existed between smoking and ICS treatment .
CONCLUSIONS	Even in the presence of smoking , long-term ICS treatment may lead to anti-inflammatory effects in the lung .
CONCLUSIONS	Some anti-inflammatory ICS effects are comparable in smokers and ex-smokers with COPD , other effects are cell-specific .
CONCLUSIONS	The clinical relevance of these findings , however , are uncertain .

###25323538
BACKGROUND	Inadequate skin care may increase morbidity in preterm infants .
BACKGROUND	Skin care practices that support skin maturation have barely been investigated .
OBJECTIVE	To investigate the effect of sunflower seed oil ( SSO ) on skin barrier development in low-birth-weight premature infants .
METHODS	22 preterm infants ( < 48 h after birth , 1,500-2 ,500 g ) were randomized into group C ( control ) and group SSO , receiving daily SSO application during the first 10 postnatal days , followed by no intervention .
METHODS	Transepidermal water loss ( TEWL ) , stratum corneum hydration ( SCH ) , skin pH and sebum were measured < 48 h after birth and on postnatal days 5 , 11 and 21 on the forehead , abdomen , thigh and buttock .
RESULTS	Skin pH decreased , while sebum remained stable in both groups .
RESULTS	In group C , TEWL remained stable ; in group SSO , TEWL increased significantly on the abdomen , leg and buttock until day 11 , followed by a decrease after SSO application had been stopped .
RESULTS	Abdomen SCH remained stable in group C , but continuously decreased in group SSO until day 21 .
CONCLUSIONS	SSO application may retard postnatal skin barrier maturation in preterm infants .

###25430726
BACKGROUND	It is common in public health and epidemiology that the outcome of interest is counts of events occurrence .
BACKGROUND	Analysing these data using classical linear models is mostly inappropriate , even after transformation of outcome variables due to overdispersion .
BACKGROUND	Zero-adjusted mixture count models such as zero-inflated and hurdle count models are applied to count data when over-dispersion and excess zeros exist .
BACKGROUND	Main objective of the current paper is to apply such models to analyse risk factors associated with human helminths ( S. haematobium ) particularly in a case where there 's a high proportion of zero counts .
METHODS	The data were collected during a community-based randomised control trial assessing the impact of mass drug administration ( MDA ) with praziquantel in Malawi , and a school-based cross sectional epidemiology survey in Zambia .
METHODS	Count data models including traditional ( Poisson and negative binomial ) models , zero modified models ( zero inflated Poisson and zero inflated negative binomial ) and hurdle models ( Poisson logit hurdle and negative binomial logit hurdle ) were fitted and compared .
RESULTS	Using Akaike information criteria ( AIC ) , the negative binomial logit hurdle ( NBLH ) and zero inflated negative binomial ( ZINB ) showed best performance in both datasets .
RESULTS	With regards to zero count capturing , these models performed better than other models .
CONCLUSIONS	This paper showed that zero modified NBLH and ZINB models are more appropriate methods for the analysis of data with excess zeros .
CONCLUSIONS	The choice between the hurdle and zero-inflated models should be based on the aim and endpoints of the study .

###25194452
OBJECTIVE	To investigate the effect of cryotherapy after elbow arthrolysis on elbow pain , blood loss , analgesic consumption , range of motion , and long-term elbow function .
METHODS	Prospective , single-blinded , randomized controlled study .
METHODS	University hospital .
METHODS	Patients ( N = 59 ; 27 women , 32 men ) who received elbow arthrolysis .
METHODS	Patients were randomly assigned into a cryotherapy group ( n = 31 , cryotherapy plus standard care ) or a control group ( n = 28 , standard care ) .
METHODS	Elbow pain at rest and in motion were measured using a visual analog scale ( VAS ) on postoperative day ( POD ) 1 to POD 7 and at 2 weeks and 3 months after surgery .
METHODS	Blood loss and analgesic consumption were recorded postoperatively .
METHODS	Elbow range of motion ( ROM ) was measured before surgery and on POD 1 , POD 7 , and 3 months after surgery .
METHODS	The Mayo Elbow Performance Score ( MEPS ) was evaluated preoperatively and 3 months postoperatively .
RESULTS	VAS scores were significantly lower in the cryotherapy group during the first 7 PODs , both at rest and in motion ( P < .05 ) .
RESULTS	There were no significant differences between the 2 groups in VAS scores at 2 weeks and 3 months after surgery .
RESULTS	Less sufentanil was consumed by the cryotherapy group than the control group for pain relief ( P < .01 ) .
RESULTS	No significant differences were found in blood loss , ROM , and MEPS between the 2 groups ( P > .05 ) .
CONCLUSIONS	Cryotherapy is effective in relieving pain and reducing analgesic consumption for patients received elbow arthrolysis .
CONCLUSIONS	The application of cryotherapy will not affect blood loss , ROM , or elbow function .

###24899076
OBJECTIVE	To assess the effectiveness of brief motivational intervention for alcohol and drug use in young adult primary care patients in a low-income population and country .
METHODS	A randomized controlled trial in a public-sector clinic in Delft , a township in the Western Cape , South Africa recruited 403 patients who were randomized to either single-session , nurse practitioner-delivered Brief Motivational Intervention plus referral list or usual care plus referral list , and followed up at 3 months .
RESULTS	Although rates of at-risk alcohol use and drug use did not differ by treatment arm at follow-up , patients assigned to the Brief Motivational Intervention had significantly reduced scores on ASSIST ( Alcohol , Smoking and Substance Involvement Screening Test ) for alcohol-the most prevalent substance .
CONCLUSIONS	Brief Motivational Intervention may be effective at reducing at-risk alcohol use in the short term among low-income young adult primary care patients ; additional research is needed to examine long-term outcomes .

###25218597
BACKGROUND	Prior studies have provided evidence that lifestyle change prevents or delays the occurrence of type 2 diabetes mellitus .
BACKGROUND	The challenge is to translate research evidence for type 2 diabetes mellitus prevention into health care settings .
OBJECTIVE	We investigated the effect of medical nutrition therapy ( MNT ) compared with usual care on fasting plasma glucose values , glycated hemoglobin ( HbA1c ) , serum lipid levels , and Diabetes Risk Score , from baseline to the end of a 12-week intervention in overweight or obese adults with prediabetes .
METHODS	Prospective , randomized , parallel group study of 76 adults with impaired fasting plasma glucose or an HbA1c of 5.7 % to 6.4 % , recruited between April 2010 and May 2011 who completed a 12-week intervention period .
METHODS	The primary outcome measure was fasting plasma glucose .
METHODS	Secondary outcome measures were HbA1c , serum lipid levels , and Diabetes Risk Score .
METHODS	A factorial repeated measures analysis of variance was used to make comparisons between the two groups ( the MNT and usual care groups ) and two measures of time ( baseline and 12 weeks postintervention ) .
METHODS	Data analysis was performed using the Statistical Package for the Social Sciences ( release 19.0 , 2010 , SPSS Inc ) .
RESULTS	There was a significant interaction for group assignment and HbA1c ( P = 0.01 ) , with the MNT group experiencing significantly lower HbA1c levels than the usual care group ( 5.79 % vs 6.01 % ) after the 12-week intervention .
RESULTS	There was a significant interaction for group assignment and Diabetes Risk Score ( P = 0.001 ) .
RESULTS	Diabetes Risk Score for the MNT group decreased from 17.543.69 to 15.313.79 compared with the usual care group score , which went from 17.234.69 to 16.834.73 .
RESULTS	Regardless of group assignment , both groups experienced a reduction in total cholesterol ( P = 0.01 ) and low-density lipoprotein cholesterol ( P = 0.04 ) level .
CONCLUSIONS	The results demonstrate that individualized MNT is effective in decreasing HbA1c level in patients diagnosed with prediabetes .

###25449222
OBJECTIVE	To evaluate the effect of an intensive early intervention on special service use at school-age .
METHODS	The Infant Health and Development Program was a randomized controlled trial of an intervention for low birth weight ( < 2500 g ) infants ages 0-3 years .
METHODS	We used multivariate logistic regression to test the association between intervention and risk of special education , remedial reading and math , and speech therapy at age 8 years .
METHODS	We also compared rates of service use between study arms among those with learning disabilities ( LDs ) .
RESULTS	There were 875 complete cases at 8-year follow-up .
RESULTS	There were no statistically significant differences between groups in risk of special education ( risk ratio [ RR ] 0.86 , 95 % CI 0.64-1 .15 ) , remedial reading ( RR 0.88 , 95 % CI 0.68-1 .14 ) , remedial math ( RR 0.92 , 95 % CI 0.63-1 .34 ) , or speech therapy ( RR 0.87 , 95 % CI 0.62-1 .23 ) .
RESULTS	The treatment arms did not differ in rates of LDs , and service use for those with LDs was low and unaffected by study group .
CONCLUSIONS	Early gains in IQ from infant interventions may not protect children as they face the educational demands of grade school .
CONCLUSIONS	Only a fraction of those having a LD were receiving school-based support services , indicating a high level of unmet need among low birth weight children with disabilities .

###25307130
OBJECTIVE	To compare baseline characteristics , treatment frequency , visual acuity ( VA ) , and morphologic outcomes of eyes with > 50 % of the lesion composed of blood ( B50 group ) versus all other eyes ( Other group ) enrolled in the Comparison of Age-Related Macular Degeneration Treatments Trials ( CATT ) .
METHODS	Prospective cohort study within a multicenter randomized clinical trial .
METHODS	CATT patients with neovascular age-related macular degeneration ( AMD ) .
METHODS	Treatment for the study eye was assigned randomly to either ranibizumab or bevacizumab and to 3 different dosing regimens over a 2-year period .
METHODS	Reading center graders evaluated baseline and follow-up morphology in color fundus photographs , fluorescein angiography ( FA ) , and optical coherence tomography ( OCT ) .
METHODS	Masked examiners tested VA. .
METHODS	Morphologic features and VA at 1 and 2 years .
RESULTS	The B50 group consisted of 84 of 1185 ( 7.1 % ) patients enrolled in CATT .
RESULTS	Baseline lesion characteristics differed between groups .
RESULTS	In the B50 group , choroidal neovascularization size was smaller ( 0.73 vs 1.83 disc areas [ DA ] ; P < 0.001 ) , total lesion size was greater ( 4.55 vs 2.31 DA ; P < 0.001 ) , total retinal thickness was greater ( 524 vs 455 m ; P = 0.02 ) , and mean VA was worse ( 56.0 vs 60.9 letters ; P = 0.002 ) .
RESULTS	Increases in mean VA were similar in the B50 and Other groups at 1 year ( +9.3 vs +7.2 letters ; P = 0.22 ) and at 2 years ( 9.0 vs 6.1 letters ; P = 0.17 ) .
RESULTS	Eyes treated PRN received a similar number of injections in the 2 groups ( 12.2 vs 13.4 ; P = 0.27 ) .
RESULTS	Mean lesion size in the B50 group decreased by 1.2 DA at both 1 and 2 years ( primarily owing toresolution of hemorrhage ) and increased in the Other group by 0.33 DA at 1 year and 0.91 DA at 2 years ( P < 0.001 ) .
RESULTS	Leakage on FA and fluid on OCT were similar between groups at 1 and 2 years .
CONCLUSIONS	In CATT , the B50 group had a visual prognosis similar to the Other group .
CONCLUSIONS	Lesion size decreased markedly through 2 years .
CONCLUSIONS	Eyes like those enrolled in CATT with neovascular AMD lesions composed of > 50 % blood can be managed similarly to those with less or no blood .

###24423410
BACKGROUND	Women with gestational diabetes ( GDM ) are at high risk of developing diabetes later in life .
BACKGROUND	After a GDM diagnosis , women receive prenatal care to control their blood glucose levels via diet , physical activity and medications .
BACKGROUND	Continuing such lifestyle skills into early motherhood may reduce the risk of diabetes in this high risk population .
BACKGROUND	In the Gestational Diabetes ' Effects on Moms ( GEM ) study , we are evaluating the comparative effectiveness of diabetes prevention strategies for weight management designed for pregnant/postpartum women with GDM and delivered at the health system level .
METHODS	The GEM study is a pragmatic cluster randomized clinical trial of 44 medical facilities at Kaiser Permanente Northern California randomly assigned to either the intervention or usual care conditions , that includes 2,320 women with a GDM diagnosis between March 27 , 2011 and March 30 , 2012 .
METHODS	A Diabetes Prevention Program-derived print/telephone lifestyle intervention of 13 telephonic sessions tailored to pregnant/postpartum women was developed .
METHODS	The effectiveness of this intervention added to usual care is to be compared to usual care practices alone , which includes two pages of printed lifestyle recommendations sent to postpartum women via mail .
METHODS	Primary outcomes include the proportion of women who reach a postpartum weight goal and total weight change .
METHODS	Secondary outcomes include postpartum glycemia , blood pressure , depression , percent of calories from fat , total caloric intake and physical activity levels .
METHODS	Data were collected through electronic medical records and surveys at baseline ( soon after GDM diagnosis ) , 6 weeks ( range 2 to 11 weeks ) , 6 months ( range 12 to 34 weeks ) and 12 months postpartum ( range 35 to 64 weeks ) .
CONCLUSIONS	There is a need for evidence regarding the effectiveness of lifestyle modification for the prevention of diabetes in women with GDM , as well as confirmation that a diabetes prevention program delivered at the health system level is able to successfully reach this population .
CONCLUSIONS	Given the use of a telephonic case management model , our Diabetes Prevention Program-derived print/telephone intervention has the potential to be adopted in other settings and to inform policies to promote the prevention of diabetes among women with GDM .

###24439714
OBJECTIVE	Inadvertent arterial placement of a femoral venous catheter may result in serious morbidity , including limb necrosis .
OBJECTIVE	The Flush the Line and Ultrasound the Heart ( FLUSH ) test is visualization of the heart by a subxiphoid ultrasonic view while the central catheter is flushed with agitated saline solution .
OBJECTIVE	We wish to determine whether the FLUSH test can verify proper femoral venous line placement .
METHODS	We prospectively studied a convenience sample of children undergoing cardiac catheterization , for whom both femoral venous and arterial access were part of their standard care .
METHODS	The cardiologist flushed manually agitated saline solution through each catheter in randomized sequence while the blinded physician sonographer recorded thepresence or absence of right atrial opacification .
METHODS	We calculated the sensitivity and specificity of the FLUSH test relative to our reference standard , the cardiologist 's fluoroscopic visualization of catheter wire placement .
RESULTS	Of the 51 subjects enrolled , the FLUSH test was 100 % sensitive ( 95 % confidence interval 95 % to 100 % ) and 90.3 % specific ( 95 % confidence interval 81 % to 96 % ) in confirming femoral catheter placement .
RESULTS	In no case was an arterial flush misidentified as a femoral flush .
RESULTS	The interrater reliability of the test was strong : 0.82 for all images and 0.9 for those of good quality .
CONCLUSIONS	The FLUSH test is simple and reliable , and appears to accurately confirm femoral venous line placement .

###25066025
BACKGROUND	Polyethylene glycol 3350 plus sports drink ( PEG-SD ) is a hypo-osmotic purgative commonly used for colonoscopy , though little safety data are available .
OBJECTIVE	To evaluate the effect of PEG-SD on serum sodium ( Na ) and other electrolytes compared with PEG-electrolyte solution ( PEG-ELS ) .
METHODS	We performed a single center , prospective , randomised , investigator-blind comparison of PEG-ELS to PEG-SD in out-patients undergoing colonoscopy .
METHODS	Laboratories were obtained at baseline and immediately before and after colonoscopy .
METHODS	The primary endpoint was development of hyponatraemia ( Na < 135 mmol/L ) the day of colonoscopy .
METHODS	Changes in electrolyte levels were computed as the difference between the lowest value on the day of colonoscopy and baseline .
METHODS	Purgative tolerance and efficacy were assessed .
RESULTS	A total of 389 patients were randomised ; 364 took purgative and had baseline and day of colonoscopy labs ( 180 PEG-SD , 184 PEG-ELS ) .
RESULTS	The groups were well matched except for a higher fraction of women and Blacks in PEG-ELS .
RESULTS	Seven patients ( 3.9 % ) in PEG-SD and four patients ( 2.2 % ) in PEG-ELS developed hyponatraemia ( OR = 1.82 , 95 % CI : 0.45-8 .62 , P = 0.376 ) .
RESULTS	Changes in electrolytes from baseline were small but significantly worse with PEG-SD for sodium , potassium and chloride ( P = 0.001 , 0.012 , 0.001 , respectively ) .
RESULTS	Preparation completion , adverse events , and overall colon cleansing were similar between the groups , but PEG-ELS had more excellent preparations ( 52 % vs. 30 % ; P = 0.001 ) .
CONCLUSIONS	Greater , but very modest , electrolyte changes occur with PEG-SD .
CONCLUSIONS	Hyponatraemia is infrequent with both purgatives .
CONCLUSIONS	A significant increase in hyponatraemia was not identified for PEG-SD vs. PEG-ELS , but the sample size may have been inadequate to identify a small , but clinically important difference .
CONCLUSIONS	ClinicalTrials.gov identifier NCT01299779 .

###26115578
BACKGROUND	Beclomethasone dipropionate ( BDP ) nasal aerosol ( non-aqueous ) is approved for management of seasonal and perennial allergic rhinitis ( PAR ) in adolescents and adults .
OBJECTIVE	To evaluate the efficacy and safety of BDP nasal aerosol at 80 g/day in children with PAR .
METHODS	This 12-week , phase 3 , double-blinded , placebo-controlled , parallel-group study randomized 547 children ( 4-11 years old ) with PAR to once-daily BDP nasal aerosol at 80 g/day or placebo .
METHODS	The primary end point was change from baseline in average morning and evening reflective total nasal symptom score ( rTNSS ) during the first 6 weeks of treatment in patients 6 to 11 years old .
METHODS	Changes from baseline in average morning and evening instantaneous TNSS ( iTNSS ) in children 6 to 11 years old and average rTNSS and iTNSS in children 4 to 11 years old were assessed during the first 6 weeks of treatment .
RESULTS	Improvements were significantly greater with BDP nasal aerosol than with placebo during the first 6 weeks of treatment in children 6 to 11 years old in average morning and evening rTNSS and iTNSS ( mean treatment difference-0 .66 [ P = .002 ] and-0 .58 [ P = .004 ] , respectively ) .
RESULTS	Improvements in average morning and evening rTNSS and iTNSS also were significantly greater in patients 4 to 11 years receiving BDP nasal aerosol than with placebo during the first 6 weeks of treatment ( P = .002 and P = .004 , respectively ) .
RESULTS	Similar improvements were seen during 12 weeks of treatment .
RESULTS	The safety profile of BDP nasal aerosol was comparable to that of placebo .
CONCLUSIONS	The BDP nasal aerosol at 80 g/day in children 4 to 11 years old was well tolerated and effective in controlling nasal symptoms of PAR .
BACKGROUND	www.clinicaltrials.gov , identifier NCT01783548 .

###26085531
BACKGROUND	Wound drains that are left in place for a prolonged period of time have a higher rate of bacterial contamination .
BACKGROUND	Following spinal surgery , a drain is often left in place for a longer period of time if it maintains a high output .
BACKGROUND	Given the major consequences of an infection following spinal surgery and the lack of data with regard to the use of antibiotics and drains , we performed a study of patients with a drain following spinal surgery to compare infection rates between those who were treated with antibiotics for twenty-four hours and those who received antibiotics for the duration for which the drain was in place .
METHODS	We performed a prospective randomized trial of 314 patients who underwent multilevel thoracolumbar spinal surgery followed by use of a postoperative drain .
METHODS	The patients were randomized into two groups , one of which received perioperative antibiotics for twenty-four hours ( twenty-four-hour group ) and the other of which received antibiotics for the duration that the drain was in place ( drain-duration group ) .
METHODS	Data collected included demographic characteristics , medical comorbidities , type of spinal surgery , and surgical site infection .
RESULTS	Twenty-one ( 12.4 % ) of the 170 patients in the twenty-four-hour group and nineteen ( 13.2 % ) of the 144 in the drain-duration group developed a surgical site infection ( p = 0.48 ) .
RESULTS	There were no significant differences between the twenty-four-hour and drain-duration groups with respect to demographic characteristics ( except for the American Society of Anesthesiologists [ ASA ] classification ) , operative time , type of surgery , drain output , or length of hospital stay .
CONCLUSIONS	Continuing perioperative administration of antibiotics for the entire duration that a drain is in place after spinal surgery did not decrease the rate of surgical site infections .

###24233069
OBJECTIVE	To compare the frequency of headache and the procedure time following lumbar puncture ( LP ) using a 25-gauge needle compared to a 22-gauge needle .
METHODS	4-period crossover blinded randomised controlled trial .
METHODS	Oncology unit , Royal Children 's Hospital , Melbourne .
METHODS	Children aged 4-15 years at enrolment having LPs as part of their treatment for leukaemia .
METHODS	Each child was allocated a random sequence of four LPs , two with a 22-gauge and two with a 25-gauge needle .
METHODS	The presence of post-LP headache .
METHODS	Secondary outcomes included the presence of any headache , procedure time and impact of headache on the family .
RESULTS	Data on 341 procedures in 93 randomised children were analysed .
RESULTS	There was little difference in the incidence of post-LP headache between the two needle sizes ( 22-gauge 7.2 % , 95 % CI 3.8 to 12.2 ; 25-gauge 4.6 % , 95 % CI 2.0 to 8.9 , p = 0.3 ) or in the incidence of any headache ( 22-gauge 18 % 95 % CI 12.5 to 24.6 ; 25-gauge 15 % , 95 % CI 10.0 to 21.1 , p = 0.4 ) .
RESULTS	Use of the 25-gauge needle was associated with longer procedure times .
RESULTS	The incidence of post-LP headache showed little evidence of an age effect ( OR = 1.1 , 95 % CI 0.98 to 1.3 ) and was higher in girls than in boys ( 11 % vs 3 % , respectively , OR = 3.3 , 95 % CI 1.3 to 8.4 , p = 0.014 ) .
RESULTS	Fifty-five per cent of families with a child with a post-LP headache assessed the overall functional impact as moderate or severe .
CONCLUSIONS	There was little difference in the occurrence of post-LP headache or any headache between procedures carried out using the 22-gauge or 25-gauge needles .
CONCLUSIONS	Depending on the circumstances of the procedure and the experience of the operator , either gauge may be appropriate for an LP in a child .

###24428468
BACKGROUND	An interferon-free combination of the protease inhibitor ABT-450 with ritonavir ( ABT-450 / r ) , the nonnucleoside polymerase inhibitor ABT-333 , and ribavirin showed efficacy against the hepatitis C virus ( HCV ) in a pilot study involving patients with HCV genotype 1 infection .
BACKGROUND	The addition of another potent agent , the NS5A inhibitor ABT-267 , may improve efficacy , especially in difficult-to-treat patients .
BACKGROUND	This study was designed to evaluate multiple regimens of direct-acting antiviral agents and ribavirin in patients with HCV genotype 1 infection who had not received therapy previously or who had no response to prior therapy with pegylated interferon and ribavirin .
METHODS	In this phase 2b , open-label study with 14 treatment subgroups , 571 patients without cirrhosis who had not received treatment previously or who had not had a response to prior therapy were randomly assigned to a regimen of ABT-450 / r , combined with ABT-267 or ABT-333 or both , for 8 , 12 , or 24 weeks and received at least one dose of therapy .
METHODS	All the subgroups but 1 also received ribavirin ( dose determined according to body weight ) .
METHODS	The primary end point was sustained virologic response at 24 weeks after the end of treatment .
METHODS	The primary efficacy analysis compared rates between previously untreated patients who received three direct-acting antiviral agents and ribavirin for 8 weeks and those who received the same therapy for 12 weeks .
RESULTS	Among previously untreated patients who received three direct-acting antiviral agents ( with the ABT-450 / r dose administered as 150 mg of ABT-450 and 100 mg of ritonavir ) plus ribavirin , the rate of sustained virologic response at 24 weeks after treatment was 88 % among those who received the therapy for 8 weeks and 95 % among those who received the therapy for 12 weeks ( difference , -7 percentage points ; 95 % confidence interval , -19 to 5 ; P = 0.24 ) .
RESULTS	The rates of sustained virologic response across all treatment subgroups ranged from 83 to 100 % .
RESULTS	The most frequent adverse events were fatigue , headache , nausea , and insomnia .
RESULTS	Eight patients ( 1 % ) discontinued treatment owing to adverse events .
CONCLUSIONS	In this phase 2b study , all-oral regimens of antiviral agents and ribavirin were effective both in patients with HCV genotype 1 infection who had not received therapy previously and in those who had not had a response to prior therapy .
CONCLUSIONS	( Funded by AbbVie ; ClinicalTrials.gov number , NCT01464827 . )

###24222837
BACKGROUND	The challenge with fast track ( FT ) is to avoid compromising medical safety .
BACKGROUND	We aimed to investigate whether patients with acute coronary syndrome could be safely retransferred to the referral hospital on the same day after coronary angiography and/or percutaneous coronary angioplasty ( PCI ) .
RESULTS	A total of 399 consecutive patients were prospectively randomized : 206 to ordinary care ( OC ) and 193 to the FT group .
RESULTS	Of these , 30 % of patients were admitted for unstable angina pectoris and 70 % for non-ST-segment elevation myocardial infarction .
RESULTS	The FT patients were evaluated for possible same-day return after angiography and/or PCI .
RESULTS	Crossover , acute , and 30-day major events were recorded .
RESULTS	The radial approach was used in 91 and 87 % in the OC and FT group , respectively .
RESULTS	Of the FT patients , 95 % were returned on the same day and nine crossover patients ( 4.7 % ) the next day or later .
RESULTS	Major events occurred in nine patients ( 2.2 % ) ; five in the OC and four in the FT group .
RESULTS	There were a total of five events within 24 hours .
RESULTS	No events were observed during transportation and there were no early retransfers .
CONCLUSIONS	Immediate written reports and good communication with the referring hospital enabled thoroughly selected patients to be safely returned on the same day as angiography and/or PCI .

###24583364
OBJECTIVE	This study aimed to compare the clinical efficacies of percutaneous endoscopic lumbar discectomy ( PELD ) and traditional open lumbar discectomy ( OD ) .
METHODS	The pre-operative and post-operative blood loss , hospital stays and wound sizes of the patients in the two groups were recorded .
METHODS	Enzyme-Linked immunosorbent assay was used to measure the changes of interleukin-6 ( IL-6 ) , C-reactive protein ( CRP ) and creatine phosphokinase ( CPK ) pre-operation and 1 h , 6 h , 12 h , 24 h and 48 h after corresponding surgery .
METHODS	Visual Analog Scale and Modified MacNab Criteria were used to assess post-operative results .
RESULTS	Patients in the PELD group had less blood loss ( p < 0.01 ) , shorter hospitalization hours ( p < 0.01 ) and smaller surgical wounds ( p < 0.01 ) than the patients underwent traditional OD surgery .
RESULTS	MacNab evaluated that the levels of satisfaction were above 90 % in both groups post-operative six months .
RESULTS	There was no significant difference in pain index between the two groups ( p > 0.05 ) .
RESULTS	Furthermore , the levels of CRP , CPK and IL-6 in the PELD group were all lower than those in the OD group with a significant difference ( p < 0.01 ) .
CONCLUSIONS	The PELD had less damage to human tissues than the traditional OD .
CONCLUSIONS	PELD has a clear promotional value in clinical .

###25482469
BACKGROUND	Chronic pain is a common complication after inguinal hernia repair .
BACKGROUND	The objective of this randomized trial was to assess the effect of intraoperative infiltration with local anesthetic versus placebo on the development of chronic pain after inguinal hernia repair .
METHODS	Patients with single - or double-sided inguinal hernia were enrolled in a randomized , controlled , triple-blinded trial with a sequential adaptive design .
METHODS	Hernias were randomized to 1 of 2 treatment groups .
METHODS	The intervention group received a local infiltration of 20 mL bupivacaine 0.25 % and the placebo group 20 mL saline 0.9 % at the end of the operation .
METHODS	Two interim analyses were performed according to predefined stopping criteria allowing for design and sample size adaption .
METHODS	The primary endpoint was chronic pain defined on a visual analog scale ( VAS ) as 30 in any quality ( at rest , lying , walking , climbing stairs , and bending over ) 3 months postoperatively .
METHODS	A logistic regression model was built to compare the incidence of chronic pain using generalized estimating equations to adjust for clustering in bilateral hernias .
RESULTS	Among 357 patients , there were 406 hernias randomized .
RESULTS	A total of 5.8 % ( 10/173 ) experienced VAS 30 in any quality in the intervention group and 2.3 % ( 4/174 ) in the placebo group ( P = .114 ) at 3 months postoperatively .
RESULTS	Multivariable analysis revealed no evidence of between-group differences for the development of any pain ( odds ratio [ OR ] , 1.03 ; 95 % CI , 0.67-1 .57 ; P = .905 ) , whereas preoperative pain was an independent risk factor ( OR , 2.52 ; 95 % CI , 1.12-5 .68 ; P = .025 ) .
CONCLUSIONS	We did not find any evidence that intraoperative infiltration of local anesthetic had an impact on the development of chronic postoperative pain .

###26199168
OBJECTIVE	To evaluate the clinical usefulness of the Peyronie 's Disease Questionnaire ( PDQ ) .
OBJECTIVE	The relationship between subject-reported changes in PDQ psychosexual symptoms and clinical response to Peyronie 's disease ( PD ) treatment was examined .
METHODS	Combined data from the collagenase Clostridium histolyticum phase 3 study program , IMPRESS ( Investigation for Maximal Peyronie 's Reduction Efficacy and Safety Studies ) I and II , were examined .
METHODS	Changes in the PDQ PD symptom bother , psychological and physical symptoms , and penile pain were examined relative to changes in the penile curvature deformity , including penile curvature absolute mean and percent change .
METHODS	PDQ changes relative to sexual function , including International Index of Erectile Function overall satisfaction and erectile function domains , and treatment responder status , including global assessment of PD and composite responder status , were also assessed .
METHODS	Individual PDQ questions were examined to provide a clinical perspective on the change in psychosexual symptoms experienced by men with PD during treatment .
RESULTS	Improvement in PDQ PD symptom bother and psychological and physical symptoms was significantly correlated with clinical improvement in penile curvature deformity ( P. 0008 ) and sexual function ( P < .0001 ) .
RESULTS	Significant differences in PD symptom bother and psychological and physical symptoms improvement were found between treatment responders vs nonresponders ( P < .02 ) .
RESULTS	PDQ penile pain improvement among subjects reporting baseline pain4 was significantly correlated with clinical improvement in sexual function ( P. 0004 ) and was found to be greater in treatment responders vs nonresponders ( P = .003 ) .
CONCLUSIONS	The utility of the PDQ for monitoring PD-specific psychosexual symptom severity , progression , and treatment response , both clinically and in trials of men with PD , was supported .

###25171133
BACKGROUND	In patients suffering from bipolar disorders ( BPD ) , we explored to what extent oral loading of sodium valproate ( SV ) leads to more rapid symptom improvement compared to intravenous loading and oral maintenance administration .
METHODS	Ninety patients ( mean age : 35.00 years ) with BPD and currently in an acute manic state were randomly assigned to one of three study conditions : oral loading ( 20 mg/kg oral single-dose SV on the first day , then 10-15 mg/kg SV daily , divided dose ) , intravenous loading ( 20 mg/kg SV intravenous injection on the first day , then 10-15 mg/kg orally , divided dose ) , or oral maintenance administration ( 15-20 mg/kg SV daily from the beginning ) over the first 7 days of treatment .
METHODS	SV plasma levels , side effects and symptoms were evaluated at baseline and on days 1 , 3 , and 7 after commencing treatment .
RESULTS	There were significant Time-by-Group interactions for symptom improvements , symptom severity , and SV plasma levels , with positive values in the oral and intravenous loading conditions , compared to the oral maintenance condition .
RESULTS	Post hoc analyses showed that oral and intravenous conditions led to similar improvements .
CONCLUSIONS	Both oral and intravenous loading of SV led to quicker and more efficient improvement and SV plasma levels as compared to an oral maintenance regimen .

###25562685
OBJECTIVE	Schizoaffective disorder is a complex illness for which optimal treatment is not well established .
OBJECTIVE	Results of the first controlled , relapse-prevention study of paliperidone palmitate once-monthly injectable ( paliperidone monthly ) in schizoaffective disorder are presented .
METHODS	The study was conducted between September 20 , 2010 , and October 22 , 2013 .
METHODS	Patients with schizoaffective disorder ( confirmed by the Structured Clinical Interview for DSM-IV Axis I Disorders ) experiencing acute exacerbation of psychotic and depressive/manic symptoms were stabilized with paliperidone monthly as monotherapy or as adjunctive therapy to mood stabilizers or antidepressants and randomly assigned ( 1:1 ) to paliperidone monthly or placebo in a 15-month , double-blind , relapse-prevention phase .
METHODS	Randomization was stratified by administration as monotherapy or adjunctive therapy and by study center .
METHODS	The primary endpoint was time to relapse .
RESULTS	334 patients were evaluated .
RESULTS	Paliperidone monthly significantly delayed time to relapse for psychotic , depressive , and manic symptoms compared with placebo ( P < .001 , log-rank test ) .
RESULTS	Relapse risk was 2.49 times greater for placebo ( hazard ratio = 2.49 ; 95 % CI , 1.55 to 3.99 ; P < .001 , Cox proportional hazards model ) .
RESULTS	Overall relapse rates were 33.5 % for placebo and 15.2 % for paliperidone monthly .
RESULTS	For monotherapy , relapse risk was 3.38 times greater with placebo ( P = .002 ) , and for adjunctive treatment it was 2.03 times greater with placebo ( P = .021 ) .
RESULTS	Paliperidone monthly was superior to placebo in maintaining functioning as measured by the Personal and Social Performance scale ( P = .014 , mixed-model repeated-measures analysis ) .
RESULTS	The most common adverse events ( placebo , paliperidone monthly ) were increased weight ( 4.7 % , 8.5 % ) , insomnia ( 7.1 % , 4.9 % ) , schizoaffective disorder ( 5.9 % , 3.0 % ) , headache ( 3.5 % , 5.5 % ) , and nasopharyngitis ( 3.5 % , 5.5 % ) .
RESULTS	Incidence of any extrapyramidal-related adverse event was 7.1 % for placebo and 8.5 % for paliperidone monthly .
CONCLUSIONS	Paliperidone monthly as monotherapy or adjunctive therapy significantly delayed psychotic , depressive , and/or manic relapses ; reduced their risk ; and better maintained functioning in patients with schizoaffective disorder .
CONCLUSIONS	Results support the value of maintenance treatment with paliperidone monthly in schizoaffective disorder .
BACKGROUND	ClinicalTrials.gov identifier : NCT01193153 .

###24447007
OBJECTIVE	The purpose of this study was to examine the long-term effects of the Early Risers `` Skills for Success '' Conduct Problems Prevention Program ( ER ; August , Bloomquist , Realmuto , & Hektner , 2007 ) , a multifaceted program targeting social , emotional , behavioral , and academic risk and protective factors to promote adaptive psychological development .
METHODS	Based on the random assignment of their school , 245 kindergartners ( mean age = 6.6 years , SD = 0.57 ; 68.6 % male ) with elevated teacher-rated aggressive behavior either participated in ER for 3 intensive years plus 2 booster years or served as controls .
METHODS	Participants were assessed annually during the intervention with teacher and parent reports and at 2 follow-up points .
METHODS	In the current study , 129 of the original participants were reassessed with diagnostic interviews in late high school ( mean age = 16.3 , SD = 0.52 ) , and multiple imputation was used to deal appropriately with missing data .
RESULTS	Program participants had significantly fewer symptoms of conduct disorder , oppositional defiant disorder , and major depressive disorder than did controls .
RESULTS	The program 's effect on increasing social skills and parent discipline effectiveness by Grade 3 mediated these effects .
CONCLUSIONS	The results of this study provide further evidence of the long-term positive effects of multicomponent , elementary-age , targeted conduct problems prevention programs .
CONCLUSIONS	Training children in social skills and parents in effective discipline are possible mechanisms to divert maladaptive developmental cascades .

###25218337
OBJECTIVE	We aimed to the addition of synthetic 3-hydroxy-3-methyglutaryl coenzyme A ( HMG-CoA ) reductase inhibitor , simvastatin to capecitabine-cisplatin ( XP ) in patients with previously untreated advanced gastric cancer ( AGC ) .
METHODS	In this double-blind , placebo-controlled , phase III study , we enrolled patients aged 18 years or older with histological or cytological confirmed metastatic adenocarcinoma of the stomach or gastroesophageal junction ( GEJ ) at nine centres in Korea .
METHODS	Patients , stratified by disease measurability and participating site , were randomly assigned ( 1:1 ) to receive capecitabine 1000mg/m ( 2 ) twice daily for 14 days and cisplatin 80 mg/m ( 2 ) on day 1 every 3 weeks plus either simvastatin 40 mg or placebo , once daily .
METHODS	Cisplatin was given for 8 cycles ; capecitabine and simvastatin were administered until disease progression or unacceptable toxicities .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01099085 .
RESULTS	Between February 2009 and November 2012 , 244 patients were enrolled and assigned to treatment groups ( 120 simvastatin , 124 placebo ) .
RESULTS	Median progression free survival ( PFS ) for 120 patients allocated XP plus simvastatin was 5.2 months ( 95 % confidence interval ( CI ) 4.3-6 .1 ) compared with 4.63 months ( 95 % CI 3.5-5 .7 ) for 124 patients who were allocated to XP plus placebo ( hazard ratio 0.930 , 95 % CI 0.684-1 .264 ; p = 0.642 ) .
RESULTS	63 ( 52.5 % ) of 120 patients in simvastatin group and 70 ( 56.4 % ) of 124 had grade 3 or higher adverse events .
CONCLUSIONS	Addition of 40 mg simvastatin to XP does not increase PFS in our trial , although it does not increase toxicity .
CONCLUSIONS	Low dose of simvastatin ( 40 mg ) to chemotherapy is not recommended in untargeted population with AGC .

###25819865
BACKGROUND	Sensitive troponin ( Tn ) assays have been developed for the evaluation of patients with suspected acute coronary syndrome ( ACS ) .
BACKGROUND	We sought to compare the performance of a commercially available sensitive Tn I ( sTnI ) and precommercial highly sTnI ( hsTnI ) method to conventional Tn ( cTn ) assays .
METHODS	Among patients with acute chest pain but normal cTn in the emergency department of 6 centers , sTnI and hsTnI were measured at baseline , 2 and 4 hours after presentation .
METHODS	Diagnostic accuracy of sTnI and hsTnI relative to cTn for diagnosis during index hospitalization as well as their associations with coronary artery disease in patients randomized to coronary computed tomographic angiography ( CTA ) was assessed .
RESULTS	Overall , 322 patients were enrolled , of whom 161 had a CTA ; 28 had ACS ( 8.7 % ) , including 21 with unstable angina pectoris ( UAP ) .
RESULTS	Both sTnI and hsTnI values at baseline and second draw had significantly higher sensitivity for ACS and UAP than cTn and had significantly greater area under the receiver operator characteristic curve than cTn at first and second draws .
RESULTS	Compared with cTn , 29 % of ACS cases previously categorized as UAP were reclassified to acute myocardial infarction with sTnI or hsTnI .
RESULTS	An hsTnI below limit of detection had 100 % negative predictive value for ACS or significant coronary artery stenosis in those randomized to CTA .
CONCLUSIONS	In patients with acute chest discomfort , use of sTnI and hsTnI methods led to significant improvement in the early diagnostic accuracy for ACS , reclassifying one-third of UAP to myocardial infarction .
CONCLUSIONS	Very low values for hsTnI excluded underlying coronary artery disease .

###25618965
OBJECTIVE	To examine whether electric acupuncture can improve the daily life of patients with ischemic cerebral apoplexy at acute stage .
METHODS	A stratified-block randomized controlled multicenter trial was designed for this study .
METHODS	Totally 340 patients with acute ischemic cerebral apoplexy were randomly divided into an electric acupuncture group and a control group .
METHODS	In the electric acupuncture group , 170 patients were treated with electric acupuncture and routine therapy , and 170 patients in the control group with routine therapy alone .
METHODS	Major indexes for judging curative effect were Barthel index at 3 - and 6 - months follow-up visits and number of re-hospitalized patients .
METHODS	Minor indexes for judging curative effect were change in the score for nervous dysfunction at 4 and 12 weeks follow-up visits and number of patients persisting in rehabilitation treatment with acupuncture during follow-up visit .
RESULTS	Baseline data at the time of case selection between the two groups were similar .
RESULTS	The odds ratio ( OR ) was 0.92 , and the 95 % confidence interval ( CI ) was 0.49-1 .73 in disabled rate and 0.73 and 0.51-1 .05 in the number of re-hospitalized patients in the electric acupuncture group at 6-month follow up visit compared with the control group .
RESULTS	There was no difference in the score for nervous dysfunction at the end of 12-week follow-up visit between the two groups .
RESULTS	The score for nervous dysfunction at the end of 4-week treatment in the electric acupuncture group was significantly higher than that in the control group ( P < 0.05 ) .
RESULTS	The number of patients discharged from hospital who persisted in rehabilitation treatment with acupuncture in the acupuncture group was significantly higher than that in the control group .
CONCLUSIONS	Using electric acupuncture to treat patients with acute ischemic cerebral apoplexy can effectively improve the nervous dysfunction scores after 4-week treatment and their ability to deal with daily life after 6-month follow-up visit .
CONCLUSIONS	Systematic treatment with acupuncture may also reduce the number of patients with secondary apoplexy .

###24907420
OBJECTIVE	To compare the efficacy of selective hepatic vascular exclusion versus Pringle manoeuvre in partial hepatectomy for tumours adjacent to the hepatocaval junction .
METHODS	A randomized comparative trial was carried out .
METHODS	The primary endpoint was intraoperative blood loss .
METHODS	The secondary endpoints were operation time , blood transfusion , postoperative liver function recovery , procedure-related morbidity and in-hospital mortality .
RESULTS	160 patients were randomized into 2 groups : the Pringle manoeuvre group ( n = 80 ) and the selective hepatic vascular exclusion ( SHVE ) group ( n = 80 ) .
RESULTS	Intraoperative blood loss and transfusion requirements were significantly less in the SHVE group .
RESULTS	In the SHVE group , laceration of hepatic veins happened in 18 patients .
RESULTS	Profuse intraoperative blood loss of over 2 L happened in 2 patients but no patient suffered from air embolism because the hepatic veins were controlled .
RESULTS	In the Pringle group , the hepatic veins were lacerated in 20 patients , with profuse blood loss of over 2 L in 7 patients and air embolism in 3 patients .
RESULTS	The rates of postoperative bleeding , reoperation , liver failure and mortality were significantly higher and the ICU stay and hospital stay were significantly longer in the Pringle group .
CONCLUSIONS	SHVE was more efficacious than Pringle manoeuvre for partial hepatectomy in patients with tumours adjacent to the hepatocaval junction .

###24978952
BACKGROUND	Community pharmacies may potentially assist in screening for chronic conditions such as sleep disorders , which remain both under-diagnosed and untreated .
BACKGROUND	We aimed to compare a subjective risk-assessment-only questionnaire ( RAO ) for common sleep disorder screening against the same risk-assessment questionnaire plus a nasal flow monitor as an objective marker of possible underlying obstructive sleep apnea ( OSA ) ( RA + ) in a community pharmacy setting .
BACKGROUND	The primary outcome was the number of participants identified in RAO or RA + group who were likely to have and consequently be diagnosed with OSA .
BACKGROUND	Further outcomes included the number of participants identified as being at risk for , referred for , taking-up referral for , and then diagnosed with OSA , insomnia , and/or restless legs syndrome ( RLS ) in either group .
METHODS	In a cluster-randomized trial , participants were recruited through 23 community pharmacies .
METHODS	Using validated instruments , 325 ( RAO = 152 , RA + = 173 ) participants were screened for OSA , insomnia , and RLS .
RESULTS	218 ( 67 % ) participants were at risk of OSA , insomnia or RLS and these participants were referred to their primary physician .
RESULTS	The proportion of screened participants identified as being at risk of OSA was significantly higher in the RA + group ( 36 % in RAO vs. 66 % in RA + , OR 3.4 , 95 % CI ( 1.8-6 .5 ) , p < 0.001 ) .
RESULTS	A 12-month follow-up was completed in 125 RAO and 155 RA + participants .
RESULTS	Actual referral uptake was 34 % RAO , 26 % RA + , OR 4.4 , 95 % CI ( 1.4-19 .2 ) , p = 0.31 .
RESULTS	The OSA diagnosis rate was higher in the RA + arm ( p = 0.01 ) .
RESULTS	To yield a single additional confirmed OSA diagnosis , 16 people would need to be screened using the RA + protocol .
CONCLUSIONS	These results demonstrate that utilising either screening method is feasible in identifying individuals in the community pharmacy setting who are likely to have OSA , insomnia and/or RLS .
CONCLUSIONS	Secondly , adding an objective marker of OSA to a questionnaire-based prediction tool resulted in more confirmed OSA diagnoses .
BACKGROUND	ACTR.org.au ACTRN12608000628347 .

###24809770
OBJECTIVE	To evaluate the effect of nasal saline irrigation in the treatment of allergic rhinitis ( AR ) in children and to assess whether nasal saline irrigation could be used as a complementary therapy for AR in children in combination with the intranasal corticosteroids ( INS ) .
METHODS	In total , 61 children with AR were divided into three groups : the nasal irrigation , intranasal corticosteroid , and combined treatment groups .
METHODS	Symptoms and signs of AR and eosinophils ( EOS ) in the nasal secretions were evaluated after 4 weeks , 8 weeks , and 12 weeks of treatment .
RESULTS	In AR children treated with nasal irrigation and a decreased the INS dose , a significant improvement in symptoms and signs and a significant decrease in the mean EOS count in nasal secretions were observed at week 12 .
CONCLUSIONS	Nasal saline irrigation with physiological seawater is well tolerated and benefits the patients with AR , and can thus be considered a good adjunctive treatment option to maintain the effectiveness of the INS at a lower dose , thus resulting in reduced side effects and a decreased economic burden .

###25478944
OBJECTIVE	To investigate the resolution of heartburn and gastroesophageal reflux disease ( GERD ) - related sleep disturbances during the first 14 days of treatment with esomeprazole 20mg compared to placebo in subjects with frequent nighttime heartburn and GERD-related sleep disturbances .
METHODS	This was a post hoc analysis of 2 week data from two previously published , similarly designed randomized , placebo-controlled trials of 4 weeks ' duration comparing esomeprazole 20mg , 40mg ( one study ) , and placebo .
METHODS	Inclusion and exclusion criteria for both trials were the same .
BACKGROUND	NCT00628342 ; NCT00660660 .
METHODS	The main outcome measures for this analysis were the resolution and/or relief of GERD-related sleep disturbances during 2 weeks of treatment with esomeprazole 20mg or placebo .
METHODS	Resolution and/or relief of heartburn symptoms were also measured .
RESULTS	In trial 1 , 455 subjects were randomized , with 225 and 229 receiving esomeprazole 20mg and placebo , respectively .
RESULTS	In trial 2 , 276 subjects were randomized , with 142 and 132 receiving esomeprazole and placebo , respectively .
RESULTS	After 2 weeks , significantly more subjects who received esomeprazole 20mg ( 50.5 % [ 95 % confidence interval : 43.8 % -57.1 % ] and 39.4 % [ 31.2 % -47.6 % ] in trials 1 and 2 , respectively ) had resolution of sleep disturbances compared to placebo ( 19.9 % [ 14.6 % -25.2 % ] and 16.0 % [ 9.6 % -22.4 % ] , respectively ; p < 0.0001 for both trials ) .
RESULTS	The median time to resolution of sleep disturbances with esomeprazole 20mg was 1 day in both trials .
RESULTS	After 2 weeks , significantly more subjects receiving esomeprazole 20mg ( 32.3 % [ 26.1 % -38.5 % ] and 26.3 % [ 18.9 % -33.6 % ] in trials 1 and 2 , respectively ) had resolution of nighttime heartburn symptoms compared to placebo ( 5.4 % [ 2.4 % -8.4 % ] and 4.8 % [ 1.1 % -8.5 % ] , respectively ; p < 0.0001 for both trials ) .
CONCLUSIONS	Esomeprazole 20mg significantly and effectively reduced nighttime heartburn and GERD-related sleep disturbances in the first 2 weeks of treatment compared to placebo , with rapid resolution of sleep disturbances in the first days of treatment .

###25939591
BACKGROUND	Resveratrol is a naturally occurring polyphenol with purported inhibitory effects on prostate growth and cancer development .
BACKGROUND	A number of studies have demonstrated that resveratrol reduces prostate growth in animal models and reduces prostate cell growth in vitro .
BACKGROUND	Based on these pre-clinical findings , interest in resveratrol is increasing in relation to the management of benign prostate hyperplasia ( BPH ) and prostate cancer .
BACKGROUND	So far , no human trials have evaluated the effects of resveratrol on circulating androgens , prostate size , or biochemical markers of prostate size .
METHODS	In a randomized placebo controlled clinical study using two doses of resveratrol ( 150 mg or 1,000 mg resveratrol daily ) for 4 months , we evaluated the effects on prostate size , prostate specific antigen ( PSA ) and sex steroid hormones in 66 middle-aged men suffering from the metabolic syndrome ( MetS ) .
RESULTS	At baseline , prostate size and PSA were positively correlated ( R = 0.34 , P < 0.007 ) as was prostate size and age ( R = 0.37 , P < 0.003 ) .
RESULTS	Prostate size did not correlate with testosterone , free testosterone , dihydrotestosterone ( DHT ) , or any other androgen precursor at baseline .
RESULTS	The highest dose of resveratrol lowered the serum level of androstenedione 24 % ( P = 0.052 ) , dehydroepiandrosterone ( DHEA ) 41 % ( P < 0.01 ) , and dehydroepiandrosterone-sulphate ( DHEAS ) 50 % ( p < 0.001 ) , compared to the control group .
RESULTS	However , prostate size and levels of PSA , testosterone , free testosterone and DHT remained unchanged .
CONCLUSIONS	In this population of middle-aged men suffering from MetS , high dose resveratrol ( 1,000 mg daily ) administration for 4 months significantly lowered serum levels of the androgen precursors androstenedione , DHEA and DHEAS , whereas prostate size and circulating levels of PSA , testosterone , free testosterone , and dihydrotestosterone were unaffected .
CONCLUSIONS	The present study suggests that resveratrol does not affect prostate volume in healthy middle-aged men as measured by PSA levels and CT acquired prostate volumes .
CONCLUSIONS	Consequently , we find no support for the use of resveratrol in the treatment of benign prostate hyperplasia .

###24500453
OBJECTIVE	There is evidence that in nonsurgical populations , pelvic floor muscle training ( PFMT ) and lifestyle advice improves symptoms and stage of pelvic organ prolapse ( POP ) .
OBJECTIVE	Some women , however , require surgery , after which de novo symptoms can develop or additional surgery is required due to recurrence .
OBJECTIVE	Robust evidence is required as to the benefit of perioperative PFMT in the postsurgery reduction of symptoms and POP recurrence .
OBJECTIVE	The aim of this study was to assess the feasibility of and collect pilot data to inform sample size ( SS ) calculation for a multicentre randomised controlled trial ( RCT ) of perioperative PFMT following surgical intervention for POP .
METHODS	Fifty-seven participants were recruited and randomised to a treatment group ( one pre and six postoperative PFMT sessions ) or a control group ( usual care ) .
METHODS	The primary outcome measure was the Pelvic Organ Prolapse Symptom Score ( POP-SS ) at 12months ; secondary outcome measures included measurement of prolapse , the pelvic floor and questionnaires relating to urinary and bowel incontinence .
METHODS	All outcomes were measured at 0 , 6 and 12months .
RESULTS	Information on recruitment , retention and appropriateness of outcome measures for a definitive trial was gathered , and data enabled us to undertake an SS calculation .
RESULTS	When compared with the control group ( n = 29 ) , benefits to the intervention group ( n = 28 ) were observed in terms of fewer prolapse symptoms at 12months [ mean difference 3.94 ; 95 % confidence interval ( CI ) 1.35-6 .75 ; t = 3.24 , p = 0.006 ] ; however , these results must be viewed with caution due to possible selection bias .
CONCLUSIONS	With modifications to design identified in this pilot study , a multicentre RCT is feasible .

###24907640
OBJECTIVE	To determine whether the Feldenkrais method is an effective intervention for chronic neck/scapular pain in patients with visual impairment .
METHODS	Randomized controlled trial with an untreated control group .
METHODS	Low vision center .
METHODS	Patients ( N = 61 ) with visual impairment ( mean , 53.3 y ) and nonspecific chronic ( mean , 23.8 y ) neck/scapular pain .
METHODS	Participants were randomly assigned to the Feldenkrais method group ( n = 30 ) or untreated control group ( n = 31 ) .
METHODS	Patients in the treatment group underwent one 2-hour Feldenkrais method session per week for 12 consecutive weeks .
METHODS	Blind assessment of perceived pain ( visual analog scale [ VAS ] ) during physical therapist palpation of the left and right occipital , upper trapezius , and levator scapulae muscle areas ; self-assessed degree of pain on the Visual , Musculoskeletal , and Balance Complaints questionnaire ; and the Medical Outcomes Study 36-Item Short-Form Health Survey bodily pain scale .
RESULTS	Patients undergoing Feldenkrais method reported significantly less pain than the controls according to the VAS and Visual , Musculoskeletal , and Balance Complaints questionnaire ratings at posttreatment follow-up and 1-year follow-up .
RESULTS	There were no significant differences regarding the Medical Outcomes Study 36-Item Short-Form Health Survey bodily pain scale ratings .
CONCLUSIONS	Feldenkrais method is an effective intervention for chronic neck/scapular pain in patients with visual impairment .

###24802657
OBJECTIVE	Lobeglitazone is a recently approved peroxisome proliferator-activated receptor - agonist for the treatment of type 2 diabetes mellitus in Korea .
OBJECTIVE	The purpose of this study was to investigate the pharmaco kinetic properties of lobeglitazone in healthy females and to compare these with historical data in healthy males .
METHODS	This study was designed as a block-randomized , double-blind , placebo-controlled , parallel-group study .
METHODS	A single 2 or 4 mg oral dose of lobeglitazone or a placebo was randomly administered to 22 female subjects , and pharmacokinetic blood samples were obtained after dosing .
METHODS	Pharmacokinetic parameters were calculated by a non-compartmental method , and the results were compared with those previously obtained from male subjects .
METHODS	Tolerability was assessed by clinical and laboratory parameters .
RESULTS	During the study , a total of 28 adverse events ( AEs ) were observed in the lobeglitazone group ( n = 16 ) and nine AEs in the placebo group ( n = 6 ) .
RESULTS	Serious AEs or significant clinical changes were not observed .
RESULTS	After oral administration , lobeglitazone was rapidly absorbed with the time to maximum plasma concentration ( t ( max ) ) ranging from 0.5 to 4.0 h.
RESULTS	The mean ( standard deviation ) maximum plasma concentration ( C ( max ) ) and area under the plasma concentration-time curve from time zero to infinity ( AUC ( ) ) for the 2 mg dose were 214.8 ( 56.4 ) g/L and 2,251.3 ( 721.2 ) gh/L , respectively , and the corresponding values for the 4 mg dose were 310.0 ( 47.8 ) g/L and 6,942.6 ( 1,778.9 ) gh/L , respectively .
RESULTS	The ratios ( 95 % CIs ) for the geometric means ( female/male ) of the C ( max ) and AUC were 1.23 ( 0.89-1 .69 ) and 1.11 ( 0.73-1 .68 ) , respectively ( 2 mg ) , and 1.28 ( 1.01-1 .63 ) and 2.36 ( 1.60-3 .47 ) , respectively ( 4 mg ) .
CONCLUSIONS	Lobeglitazone was well-tolerated in healthy females .
CONCLUSIONS	There was no sex difference for systemic lobeglitazone exposure at a 2 mg dose ; however , female subjects showed greater systemic exposure than males after the administration of 4 mg of lobeglitazone .
CONCLUSIONS	In spite of the pharmacokinetic difference , dose adjustment based on sex alone is not needed in clinical use because therapy should be individualized for each patient to achieve glycemic control .

###24517059
OBJECTIVE	To assess the effect and safety of Jinhua Qinggan Granule ( JHG ) in treating influenza patients of wind-heat affecting Fei syndrome ( WHAFS ) .
METHODS	Totally 136 influenza patients of WHAFS were randomized by stratification into 3 groups , the high dose JHG group ( 44 cases , 10 g each time ) , the low dose JHG group ( 45 cases , 5 g JHG + 5 g placebo each time ) , and the placebo control group ( 47 cases , 10 g placebo each time ) .
METHODS	All medication was administered three times daily for 5 days .
METHODS	The fever disappearance time , the fever disappearance rate , efficacy of TCM syndrome , the disappearance rate of main symptoms and physical signs of flu , the negative rate of virus nucleic acid in the pharyngeal secretion , and safety indicators were assessed .
RESULTS	The median fever disappearance time was 32.8 h ( 95 % CI : 22.5-41 .0 h ) in the high dose JHG group , 26.0 h ( 95 % CI : 14.5-36 .5 h ) in the low dose JHG group , 39.5 h ( 95 % CI : 29.0-46 .0 h ) in the placebo control group .
RESULTS	There was statistical difference in the median fever disappearance time between the low dose JHG group and the placebo control group ( P = 0.011 ) .
RESULTS	Three days after treatment , the markedly effective rate of TCM symptoms in the low dose JHG group was 66.7 % , higher than that of the placebo control group ( 38.3 % ) , and its effective rate was superior to that of the high dose JHG group ( P = 0.043 ) .
RESULTS	Five days after treatment , the recovery rate of the low dose JHG group ( 42.2 % ) was higher than that of the high dose JHG group ( 25.0 % , P = 0.026 ) and that of the placebo control group ( 14.9 % , P = 0.002 ) .
RESULTS	The markedly effective rate of the low dose JHG group ( 86.7 % ) was higher than that of the placebo control group ( 55.3 % , P = 0.001 ) .
RESULTS	Similar effects were obtained in the low dose JHG group and the high dose JHG group , but slightly poor in partial indicators of the high dose JHG group .
RESULTS	There was no statistical difference in adverse reaction among these three groups ( P > 0.05 ) .
CONCLUSIONS	JHG was effective and safe in treating influenza patients of WHAFS .
CONCLUSIONS	Routinely low dose was the optimal dosage of JHG .

###24737912
OBJECTIVE	To evaluate the effects of golimumab therapy on achieving inactive disease or major improvement , as assessed by the Ankylosing Spondylitis Disease Activity Score ( ASDAS ) , and improvements in health-related quality of life ( HRQOL ) and productivity through 2 years in patients with AS .
METHODS	In the phase III GO-RAISE trial , 356 patients were randomized to placebo with crossover to golimumab 50 mg at Week 24 ( n = 78 ) , golimumab 50 mg ( n = 138 ) , or golimumab 100 mg ( n = 140 ) at baseline and every 4 weeks .
METHODS	The proportions of patients with ASDAS major improvement ( improvement 2.0 ) or inactive disease ( score < 1.3 ) were determined .
METHODS	HRQOL was assessed using the 36-item Medical Outcomes Study Short Form-36 physical/mental component summary ( SF-36 PCS/MCS ) scores ( normal score 50 ) .
METHODS	The effect of disease on productivity was assessed by visual analog scale ( 0-10 ) .
METHODS	Regression analyses on the association of disease activity and HRQOL were performed .
METHODS	The final assessment was at Week 104 .
RESULTS	Significantly greater proportions of golimumab-treated patients achieved ASDAS major improvement or inactive disease at weeks 14 and 24 versus placebo .
RESULTS	Through Week 104 , patients who achieved ASDAS inactive disease or major improvement had significantly greater improvements in SF-36 PCS and MCS scores and productivity than did patients not meeting these targets .
RESULTS	Among all patients , achieving ASDAS inactive disease at weeks 52 and 104 was associated with normalized SF-36 PCS/MCS scores and significant improvements in work productivity .
CONCLUSIONS	Greater proportions of golimumab-treated patients achieved ASDAS major improvement or inactive disease and improved HRQOL versus placebo .
CONCLUSIONS	Achieving an inactive disease state by ASDAS criteria ( < 1.3 ) was associated with normalized HRQOL through 2 years .

###24568148
BACKGROUND	Training increases the functional use of an upper limb prosthesis , but little is known about how people learn to use their prosthesis .
BACKGROUND	The aim of this study was to describe the changes in performance with an upper limb myoelectric prosthesis during practice .
BACKGROUND	The results provide a basis to develop an evidence-based training program .
METHODS	Thirty-one able-bodied participants took part in an experiment as well as thirty-one age - and gender-matched controls .
METHODS	Participants in the experimental condition , randomly assigned to one of four groups , practiced with a myoelectric simulator for five sessions in a two-weeks period .
METHODS	Group 1 practiced direct grasping , Group 2 practiced indirect grasping , Group 3 practiced fixating , and Group 4 practiced a combination of all three tasks .
METHODS	The Southampton Hand Assessment Procedure ( SHAP ) was assessed in a pretest , posttest , and two retention tests .
METHODS	Participants in the control condition performed SHAP two times , two weeks apart with no practice in between .
METHODS	Compressible objects were used in the grasping tasks .
METHODS	Changes in end-point kinematics , joint angles , and grip force control , the latter measured by magnitude of object compression , were examined .
RESULTS	The experimental groups improved more on SHAP than the control group .
RESULTS	Interestingly , the fixation group improved comparable to the other training groups on the SHAP .
RESULTS	Improvement in global position of the prosthesis leveled off after three practice sessions , whereas learning to control grip force required more time .
RESULTS	The indirect grasping group had the smallest object compression in the beginning and this did not change over time , whereas the direct grasping and the combination group had a decrease in compression over time .
RESULTS	Moreover , the indirect grasping group had the smallest grasping time that did not vary over object rigidity , while for the other two groups the grasping time decreased with an increase in object rigidity .
CONCLUSIONS	A training program should spend more time on learning fine control aspects of the prosthetic hand during rehabilitation .
CONCLUSIONS	Moreover , training should start with the indirect grasping task that has the best performance , which is probably due to the higher amount of useful information available from the sound hand .

###24652419
OBJECTIVE	There is no consensus about the best option of internal fixation for unstable intertrochanteric fractures .
OBJECTIVE	The aim of the present study was to compare proximal femoral nail ( PFN ) with contralateral reverse distal femoral locking compression plate ( reverse-DFLCP ) in the management of unstable intertrochanteric fractures with compromised lateral wall .
METHODS	In a randomized controlled study , from November 2011 to October 2012 , 40 patients with unstable intertrochanteric fractures with compromised lateral wall ( AO 31A 2.2 to 3.3 ) had osteosynthesis by PFN ( n = 20 ) or reverse-DFLCP ( n = 20 ) .
METHODS	Intra-operative variables compared were duration of surgery , blood loss during surgery , fluoroscopy time and surgeons perception of the surgery .
METHODS	Patients were followed up clinically for a minimum of one year .
METHODS	Functional outcome was assessed by Parker Palmer mobility score ( PPMS ) , Harris hip score ( HHS ) , and Short Form-12 .
METHODS	Failure was defined as any condition which would necessitate revision surgery with change of implant .
RESULTS	Duration of surgery ( p = 0.022 ) , blood loss during surgery ( p = 0.008 ) and fluoroscopy time ( p = 0.0001 ) were significantly less in the PFN group than in the reverse-DFLCP group .
RESULTS	No significant difference was found in type of reduction , difficulty in reduction and surgeon 's perception of surgery .
RESULTS	The PFN group had better functional outcome than the reverse-DFLCP group .
RESULTS	HHS for the PFN group was 81.53 13.21 and for the reverse-DFLCP group it was 68.43 14.36 ( p = 0.018 ) .
RESULTS	SF-12 physical ( p = 0.002 ) and mental component ( p = 0.007 ) scores in the PFN group was significantly better than in the reverse-DFLCP group .
RESULTS	There was one failure in the PFN group as compared to six in the reverse-DFLCP group ( p = 0.036 ) .
CONCLUSIONS	Due to favourable intra-operative variables , better functional outcome and lower failure rates , we conclude that PFN is a better implant than reverse-DFLCP for intertrochanteric fractures with compromised lateral wall .

###24914244
OBJECTIVE	To determine the incidence of pancreatitis and pancreatic cancer in the SAVOR-TIMI 53 trial .
METHODS	A total of 16,492 type 2 diabetic patients 40 years old with established cardiovascular ( CV ) disease or CV risk factors were randomized to saxagliptin or placebo and followed for 2.1 years .
METHODS	Outcome measures were investigator reported with blinded expert adjudication of total pancreatitis ( acute and chronic ) and reported cases of pancreatic cancer .
RESULTS	Trial investigators reported 35 events of pancreatitis in each treatment arm in 63 patients ( 33 [ 0.40 % ] in the saxagliptin arm and 30 [ 0.37 % ] in control arm ) , with a hazard ratio ( HR ) of 1.09 ( 95 % CI 0.66-1 .79 , P = 0.80 ) .
RESULTS	Adjudication confirmed pancreatitis in 24 patients ( 26 events ) in the saxagliptin arm ( 0.29 % ) and 21 patients ( 25 events ) in placebo arm ( 0.26 % ) , with an HR of 1.13 ( 0.63-2 .06 , P = 0.77 ) .
RESULTS	Cases of definite acute pancreatitis were confirmed in 17 ( 0.2 % ) vs. 9 ( 0.1 % ) ( HR 1.88 [ 0.86-4 .41 ] , P = 0.17 ) , definite plus possible pancreatitis in 22 vs. 16 ( HR 1.36 [ 0.72-2 .64 ] , P = 0.42 ) , and chronic pancreatitis in 2 vs. 6 ( HR 0.33 [ 0.05-1 .44 ] , P = 0.18 ) in the saxagliptin and placebo arms , respectively .
RESULTS	No differences in time to event onset , concomitant risk factors for pancreatitis , investigator-reported causality from study medication or disease severity , and outcome were found between treatment arms .
RESULTS	The investigators reported 5 and 12 cases of pancreatic cancer in the saxagliptin and placebo arms , respectively ( HR 0.42 [ 0.13-1 .12 ] , P = 0.09 ) .
CONCLUSIONS	In the SAVOR-TIMI 53 trial , within 2.1 years of follow-up , risk for pancreatitis in type 2 diabetic patients treated with saxagliptin was low and apparently similar to placebo , with no sign of increased risk for pancreatic cancer .
CONCLUSIONS	Further studies are needed to completely resolve the pancreatic safety issues with incretin-based therapy .

###24854414
OBJECTIVE	Most phases 2 and 3 blinded randomized clinical trials package study drug , e.g. , active and placebo , into drug kits for distribution to investigational sites .
OBJECTIVE	Kits are made so that it is not possible to determine the type of drug in the kit .
OBJECTIVE	This enables investigators to administer drug to patients in a manner that blinds investigators and patients .
OBJECTIVE	Kits are labeled with unique kit IDs that code for the drug type .
OBJECTIVE	Kit lists contain the assignment of kit IDs to drug .
OBJECTIVE	Algorithms for making kit lists , like algorithms for randomizing patients , incorporate randomness to ensure investigators and patients are blind to the process .
OBJECTIVE	This paper reviews three types of kit list : blocked , double randomized , and scrambled , and discusses the operational benefits of what a pharmaceutical company might obtain using scrambled lists along with an overview of the challenges of generating and extending the lists for large trials .
METHODS	We reviewed the operational characteristics of three types of kit list : blocked , double randomized , and scrambled .
RESULTS	Blocked kit lists were a popular choice until their unblinding and operational deficiencies became well known .
RESULTS	The many difficulties associated with blocked kit lists are unnecessary and can be avoided by using a double randomized kit list or a scrambled kit list .
RESULTS	Compared to double randomized kit lists , scrambled kit lists can be more easily extended due to their advantage of having randomly sized gaps between kit IDs .
CONCLUSIONS	Among the three types of kit list , scrambled kit lists offer the most flexibility .
CONCLUSIONS	The adoption of scrambled kit lists has in practice provided the many operational benefits described in this paper .

###24525158
BACKGROUND	The double-blind phase of the EARLY study of bosentan remains the only randomized controlled trial of a PAH-targeted therapy in World Health Organization functional class ( FC ) II patients .
BACKGROUND	We report on the efficacy , safety , disease worsening , survival and prognostic factors in mildly symptomatic pulmonary arterial hypertension ( PAH ) patients treated with bosentan in the open-label extension phase of the EARLY study .
METHODS	Exploratory efficacy outcomes included 6-minute walk distance ( 6 MWD ) and WHO FC .
METHODS	Adverse events were recorded .
METHODS	Kaplan-Meier analysis was used to estimate time to first PAH worsening event ( death , initiation of intravenous or subcutaneous prostanoids , atrial septostomy or lung transplantation ) and survival .
METHODS	Cox regression analysis determined factors prognostic of survival .
RESULTS	Median exposure to bosentan ( n = 173 ) was 51 months .
RESULTS	At the end of the bosentan-treatment assessment period , 77.8 % of patients were in WHO FC I/II .
RESULTS	Adverse events led to discontinuation of bosentan in 20.2 % of patients .
RESULTS	Aminotransferase elevations > 3 upper limit of normal occurred in 16.8 % .
RESULTS	Four-year PAH-event-free survival and survival were 79.5 % ( 95 % confidence intervals [ 95 % CI ] 73.4 , 85.6 ) and 84.8 % [ 95 % CI 79.4 , 90.2 ] , respectively .
RESULTS	Low 6 MWD , low mixed venous oxygenation , high N-terminal pro hormone of brain natriuretic peptide levels and PAH associated with connective tissue disease were associated with a higher risk of death .
CONCLUSIONS	The majority of patients exposed to long-term bosentan maintained or improved their functional class .
CONCLUSIONS	Approximately 20 % of the patients discontinued treatment because of adverse events , which were most commonly PAH worsening and elevated liver enzymes .

###25923435
BACKGROUND	Pipecuronium is a steroidal neuromuscular blocking agent .
BACKGROUND	Sugammadex , a relaxant binding - cyclodextrin derivative , reverses the effect of rocuronium , vecuronium , and pancuronium .
BACKGROUND	We investigated whether sugammadex reverses moderate pipecuronium-induced neuromuscular blockade ( NMB ) and the doses required to achieve reversal .
METHODS	This single-center , randomized , double-blind , 5-group parallel-arm study comprised 50 patients undergoing general anesthesia with propofol , sevoflurane , fentanyl , and pipecuronium .
METHODS	Neuromuscular monitoring was performed with acceleromyography ( TOF-Watch SX ) according to international standards .
METHODS	When the NMB recovered spontaneously to train-of-four count 2 , patients randomly received 1.0 , 2.0 , 3.0 , or 4.0 mg/kg of sugammadex or placebo .
METHODS	Recovery time from sugammadex injection to normalized train-of-four ( TOF ) ratio 0.9 was the primary outcome variable .
METHODS	The recovery time from the sugammadex injection to final T1 was the secondary end point .
METHODS	Postoperative neuromuscular functions were also assessed .
RESULTS	Each patient who received sugammadex recovered to a normalized TOF ratio of 0.9 within 5.0 minutes ( 95 % lower confidence interval for the lowest dose 70.1 % ; for all doses 90.8 % ) and 79 % of these patients reached a normalized TOF ratio 0.9 within 2.0 minutes ( 95 % lower confidence interval for the lowest dose 26.7 % ; for all doses 63.7 % ) .
RESULTS	T1 recovered several minutes after the TOF ratio .
RESULTS	No residual postoperative NMB was observed .
CONCLUSIONS	Sugammadex adequately and rapidly reverses pipecuronium-induced moderate NMB during sevoflurane anesthesia .
CONCLUSIONS	Once the train-of-four count has spontaneously returned to 2 responses following pipecuronium administration , a dose of 2.0 mg/kg of sugammadex is sufficient to reverse the NMB .

###24429320
BACKGROUND	Exposure to household air pollution ( HAP ) causes 4 million deaths annually , and strategies to reduce HAP exposure are urgently required .
OBJECTIVE	To evaluate the acceptability and feasibility of conducting a trial of a cookstove intervention in rural Malawi .
METHODS	Non-smoking women were randomised to continuing to use an open fire ( control ) or to using a wood-burning clay cookstove ( intervention ) .
METHODS	Symptom burden , oxygen saturation and exhaled carbon monoxide ( eCO ) were assessed at baseline and 7-day follow-up .
METHODS	A subset of women underwent HAP exposure monitoring .
RESULTS	Of 51 women recruited , 50 ( 98 % ) completed the main study .
RESULTS	The methodology was acceptable to participants .
RESULTS	Headache , back pain and cough were the most commonly reported symptoms at baseline and follow-up .
RESULTS	Median eCO was within normal limits , but with a difference of 0.5 parts per million ( ppm ) in median change of eCO from baseline to follow-up seen between the two groups ( P = 0.035 ) .
RESULTS	The peak ambient CO concentration detected was 150 ppm .
CONCLUSIONS	This study suggests that a large cookstove intervention trial in Malawi would be feasible with careful community sensitisation .
CONCLUSIONS	Monitoring exposure to HAP is challenging , and further studies evaluating potential biomarkers of exposure , including eCO , should be undertaken .

###24244349
BACKGROUND	In schizophrenia , sex specific dimorphisms related to age of onset , course of illness and response to antipsychotic treatment may be mirrored by sex-related differences in the underlying molecular pathways .
RESULTS	Here , we have carried out multiplex immunoassay profiling of sera from 4 independent cohorts of first episode antipsychotic naive schizophrenia patients ( n = 133 ) and controls ( n = 133 ) to identify such sex-specific illness processes in the periphery .
RESULTS	The concentrations of 16 molecules associated with hormonal , inflammation and growth factor pathways showed significant sex differences in schizophrenia patients compared with controls .
RESULTS	In female patients , the inflammation-related analytes alpha-1-antitrypsin , B lymphocyte chemoattractant BLC and interleukin-15 showed negative associations with positive and negative syndrome scale ( PANSS ) scores .
RESULTS	In male patients , the hormones prolactin and testosterone were negatively associated with PANSS ratings .
RESULTS	In addition , we investigated molecular changes in a subset of 33 patients before and after 6 weeks of treatment with antipsychotics and found that treatment induced sex-specific changes in the levels of testosterone , serum glutamic oxaloacetic transaminase , follicle stimulating hormone , interleukin-13 and macrophage-derived chemokine .
RESULTS	Finally , we evaluated overlapping and distinct biomarkers in the sex-specific molecular signatures in schizophrenia , major depressive disorder and bipolar disorder .
CONCLUSIONS	We propose that future studies should investigate the common and sex-specific aetiologies of schizophrenia , as the current findings suggest that different therapeutic strategies may be required for male and female patients .

###24254537
OBJECTIVE	The efficacy of concomitant ablation techniques in patients with paroxysmal atrial fibrillation ( AF ) undergoing mitral valve surgery remains under debate .
OBJECTIVE	The aim of this prospective , randomized , single-centre study was to compare pulmonary vein isolation ( PVI ) only versus a left atrial maze ( LAM ) procedure in patients with paroxysmal AF during mitral valve surgery .
METHODS	Between February 2009 and June 2011 , 52 patients with a mean age of 54.2 ( standard deviation 7.2 years ) underwent mitral valve surgery and concomitant bipolar radiofrequency ablation for paroxysmal AF .
METHODS	Patients were randomized into the PVI group ( n = 27 ) and the LAM group ( n = 25 ) .
METHODS	After surgery , an implantable loop recorder for continuous electrocardiography ( ECG ) monitoring was implanted .
METHODS	Patients with an AF burden ( AF % ) of < 0.5 % were considered AF free ( responders ) .
METHODS	The mean follow-up was 18.6 months ( standard deviation 2.1 months ) , and the patient ' data were evaluated every 3 months .
RESULTS	All patients were alive at discharge .
RESULTS	No procedure-related complications occurred for either the ablation or the loop recorder implantation .
RESULTS	Mean aortic clamping and ablation times were significantly longer in the LAM group than in the PVI group .
RESULTS	The incidence of early AF paroxysm recurrence was significantly higher in the PVI group than in the LAM group ( 62.9 vs 24.0 % , P < 0.001 ) .
RESULTS	At 20 months after surgery , 15 ( 55.6 % ) of the 27 patients in the PVI group and 22 ( 88.0 % ) of the 25 patients in the LAM group had no documented atrial arrhythmias and were considered responders ( AF burden < 0.5 % ) .
RESULTS	The mean AF burden during all follow-up periods was significantly lower in the LAM group ( 23.6 8.7 % ) than in the PVI group ( 6.8 2.2 % ) ( P < 0.001 ) .
CONCLUSIONS	According to continuous ECG monitoring data , freedom from AF was significantly higher after the concomitant LAM procedure than after PVI in patients with paroxysmal AF who underwent mitral valve surgery .

###25440324
BACKGROUND	Stroke survivors represent a target population in need of intervention strategies to promote cognitive function and prevent dementia .
BACKGROUND	Both exercise and recreational activities are promising strategies .
BACKGROUND	We assessed the effect of a 6-month exercise and recreation program on executive functions in adults with chronic stroke .
METHODS	A 6-month ancillary study within a multicentre randomized trial .
METHODS	Twenty-eight chronic stroke survivors ( ie , 12 months since an index stroke ) were randomized to 1 of 2 experimental groups : intervention ( INT ; n = 12 ) or delayed intervention ( D-INT ; n = 16 ) .
METHODS	Participants of the INT group received a 6-month community-based structured program that included 2 sessions of exercise training and 1 session of recreation and leisure activities per week .
METHODS	Participants of the D-INT group received usual care .
METHODS	The primary outcome measure was the Stroop Test , a cognitive test of selective attention and conflict resolution .
METHODS	Secondary cognitive measures included set shifting and working memory .
METHODS	Mood , functional capacity , and general balance and mobility were additional secondary outcome measures .
RESULTS	Compared with the D-INT group , the INT group significantly improved selective attention and conflict resolution ( P = .02 ) , working memory ( P = .04 ) , and functional capacity ( P = .02 ) at the end of the 6-month intervention period .
RESULTS	Improved selective attention and conflict resolution was significantly associated with functional capacity at 6 months ( r = .39 ; P = .04 ) .
CONCLUSIONS	This is the first randomized study to demonstrate that an exercise and recreation program can significantly benefit executive functions in community-dwelling chronic stroke survivors who are mildly cognitively impaired-a population at high-risk for dementia and functional decline .
CONCLUSIONS	Thus , clinicians should consider prescribing exercise and recreational activities in the cognitive rehabilitation of chronic stroke survivors .

###24222194
BACKGROUND	This report describes the results of an analysis of patient-reported outcomes from EMILIA ( TDM4370g/BO21977 ) , a randomized phase 3 study of the antibody-drug conjugate trastuzumab emtansine ( T-DM1 ) versus capecitabine and lapatinib in human epidermal growth factor receptor 2 ( HER2 ) - positive locally advanced or metastatic breast cancer .
METHODS	A secondary endpoint of the EMILIA study was time to symptom worsening ( time from randomization to the first documentation of a 5-point decrease from baseline ) as measured by the Trial Outcome Index Physical/Functional/Breast ( TOI-PFB ) subset of the Functional Assessment of Cancer Therapy-Breast questionnaire .
METHODS	Predefined exploratory patient-reported outcome endpoints included proportion of patients with a clinically significant improvement in symptoms ( per TOI-PFB ) and proportion of patients with diarrhea symptoms ( per Diarrhea Assessment Scale ) .
RESULTS	In the T-DM1 arm , 450 of 495 patients had a baseline and 1 postbaseline TOI-PFB score versus 445 of 496 patients in the capecitabine-plus-lapatinib arm .
RESULTS	Time to symptom worsening was delayed in the T-DM1 arm versus the capecitabine-plus-lapatinib arm ( 7.1 months versus 4.6 months , respectively ; hazard ratio = 0.796 ; P = .0121 ) .
RESULTS	In the T-DM1 arm , 55.3 % of patients developed clinically significant improvement in symptoms from baseline versus 49.4 % in the capecitabine-plus-lapatinib arm ( P = .0842 ) .
RESULTS	Although similar at baseline , the number of patients reporting diarrhea symptoms increased 1.5 - to 2-fold during treatment with capecitabine and lapatinib but remained near baseline levels in the T-DM1 arm .
CONCLUSIONS	Together with the EMILIA primary data , these results support the concept that T-DM1 has greater efficacy and tolerability than capecitabine plus lapatinib , which may translate into improvements in health-related quality of life .

###24927225
OBJECTIVE	To examine the effects of an individualized outdoor activity intervention carried out by volunteers on depressive symptoms among community-living older people with severe mobility limitations who have difficulties accessing the outdoors independently .
METHODS	Secondary analyses of the ` Volunteering , Access to Outdoor Activities and Wellbeing in Older People ' ( VOW ) data ( ISRCTN56847832 ) .
METHODS	VOW was a randomized single blinded two-arm controlled trial conducted in Jyvskyl , Finland , in 2009-2011 .
METHODS	At baseline , 121 people aged 67-92 years with severe mobility limitations were interviewed at home and randomized into either an intervention or waiting list control group .
METHODS	Volunteers ( n = 47 ) had retired from regular work and were trained for the study .
METHODS	A volunteer assisted the participant in attending recreational out-of-home activities once a week for three months .
METHODS	Depressive symptoms were assessed using the Center for the Epidemiological Studies Depression Scale ( CES-D ) .
RESULTS	In the intervention group the CES-D score did not change during the intervention ( from 15.1 standard error 0.9 to 15.1 0.9 ) , while in the control group it increased from 17.0 1.3 to 19.1 1.4 ( intervention effect p = .096 ) .
RESULTS	Among the subgroups with minor depressive symptoms at baseline ( CES-D score 16-20 ) , the CES-D score decreased in the intervention group and increased in the control group ( p = .025 ) .
CONCLUSIONS	A three-month outdoor activity intervention may improve mood among older people with severe mobility limitations .
CONCLUSIONS	More randomized controlled trials of the topic are needed .

###24981150
OBJECTIVE	We aimed to determine the efficacy of fennel and low-dose combined oral contraceptive ( LD-COC ) on inducing menstrual bleeding and method continuation in women using depot medroxyprogesterone acetate ( DMPA ) who had no menstrual bleeding within the previous 45 to 140 days .
METHODS	In this double-blind double-dummy trial , 78 married women referred to public health centers in Hamadan , Iran , who complained of menstrual cessation induced by DMPA were randomly assigned into fennel , LD-COC or placebo groups with an allocation ratio of 1:1:1 .
METHODS	All participants received two fennel or placebo capsules and one placebo or LD-COC pill daily for 21 days .
METHODS	We evaluated menstrual bleeding using the Higham pictorial chart within 40 days following initiating intervention .
METHODS	Data were analyzed using chi-square or analysis of variance .
RESULTS	There was no loss to follow-up .
RESULTS	Significantly more women in the fennel ( 73 % ) and LD-COC ( 81 % ) groups experienced menstrual bleeding compared to the placebo ( 19 % ) group [ relative risk ( RR ) 3.1 , 95 % confidence interval ( CI ) 1.6 to 6.2 ; RR 4.2 , 95 % CI 1.9 to 9.4 , respectively ] .
RESULTS	Mean amount of menstrual bleeding among those who experienced menstruation was significantly higher in the fennel group ( 21 cc ) than both the LD-COC ( 14 cc ) and placebo ( 12 cc ) groups .
RESULTS	Also , women using fennel ( 73 % ) and LD-COC ( 65 % ) were significantly more likely than those using placebo ( 31 % ) to have subsequent DMPA injection [ RR 2.5 ( 95 % CI 1.3 to 4.9 ) and RR 2.0 ( 95 % CI 1.1 to 3.7 ) , respectively ] .
CONCLUSIONS	Fennel and LD-COC can resolve DMPA-induced amenorrhea and increase continuation rate of this contraceptive method .

###24290979
BACKGROUND	Buprenorphine pharmacotherapy for opioid-dependent pregnant women is associated with maternal and neonatal outcomes superior to untreated opioid dependence .
BACKGROUND	However , the literature is inconsistent regarding the possible existence of a dose-response relationship between maternal buprenorphine dose and neonatal clinical outcomes .
METHODS	The present secondary analysis study ( 1 ) examined the relationship between maternal buprenorphine dose at delivery and neonatal abstinence syndrome ( NAS ) peak score , estimated gestational age at delivery , Apgar scores at 1 and 5 min , neonatal head circumference , length , and weight at birth , amount of morphine needed to treat NAS , duration of NAS treatment , and duration of neonatal hospital stay and ( 2 ) compared neonates who required pharmacotherapy for NAS to neonates who did not require such pharmacotherapy on these same outcomes , in 58 opioid-dependent pregnant women receiving buprenorphine as participants in a randomized clinical trial .
RESULTS	( 1 ) Analyses failed to provide evidence of a relationship between maternal buprenorphine dose at delivery and any of the 10 outcomes ( all p-values > .48 ) and ( 2 ) significant mean differences between the untreated ( n = 31 ) and treated ( n = 27 ) for NAS groups were found for duration of neonatal hospital stay and NAS peak score ( both p-values < .001 ) .
CONCLUSIONS	( 1 ) Findings failed to support the existence of a dose-response relationship between maternal buprenorphine dose at delivery and any of 10 neonatal clinical outcomes , including NAS severity and ( 2 ) that infants treated for NAS had a higher mean NAS peak score and , spent a longer time in the hospital than did the group not treated for NAS is unsurprising .

###24254493
BACKGROUND	Pulse frequency is one of the key determinants of analgesic outcomes by transcutaneous electrical nerve stimulation ( TENS ) .
BACKGROUND	However , optimal settings remain unclear .
OBJECTIVE	To compare the effects of different frequencies of TENS , on pressure pain threshold and tolerance .
METHODS	Currents with pulse duration of 110 s , and pulse frequencies of 60 pps or 150 pps were applied on the volar aspects of the dominant forearms of 20 healthy volunteers , on two consecutive days , in a randomized order .
METHODS	Threshold and tolerance were measured at the beginning , after the 15th and 30th minutes of the applications , and 30 minutes after the applications .
RESULTS	Pressure pain threshold and tolerance values were higher at the 150 pps frequency , at all measurement times ( p < 0.05 ) .
RESULTS	However , no frequencyXtime interaction and time-dependent changes were found for the outcome measures ( p > 0.05 ) .
CONCLUSIONS	These findings established that , at 150 pps conventional TENS , threshold and tolerance values were consistently higher .
CONCLUSIONS	These results are presented to inform future research regarding optimal conventional TENS parameters and to provide support for clinical applications .

###25047592
OBJECTIVE	Disease relapses are frequent in antineutrophil cytoplasmic antibody-associated vasculitis ( AAV ) .
OBJECTIVE	This study was undertaken to evaluate outcomes in patients with AAV who are re-treated with rituximab ( RTX ) and prednisone for severe disease relapses .
METHODS	The Rituximab in AAV trial was a randomized , double-blind , placebo-controlled trial comparing the rates of remission induction among patients treated with RTX ( n = 99 ) and patients treated with cyclophosphamide ( CYC ) followed by azathioprine ( AZA ) ( n = 98 ) .
METHODS	Prednisone was tapered to discontinuation after 5.5 months .
METHODS	After remission was achieved , patients who experienced a severe disease relapse between months 6 and 18 were eligible to receive RTX and prednisone on an open-label basis according to a prespecified protocol .
METHODS	Investigators remained blinded with regard to the original treatment assignment .
RESULTS	Twenty-six patients received RTX for disease relapse after remission had initially been achieved with their originally assigned treatment .
RESULTS	Fifteen of these patients were initially randomized to receive RTX and 11 to receive CYC/AZA .
RESULTS	Thirteen ( 87 % ) of the patients originally assigned to receive RTX and 10 ( 91 % ) originally assigned to receive CYC/AZA achieved remission again with open-label RTX ( an overall percentage of 88 % ) .
RESULTS	In half of the patients treated with open-label RTX , prednisone could be discontinued entirely .
RESULTS	Patients in this cohort experienced fewer adverse events compared to the overall study population ( 4.7 adverse events per patient-year versus 11.8 adverse events per patient-year ) .
CONCLUSIONS	Re-treatment of AAV relapses with RTX and glucocorticoids appears to be a safe and effective strategy , regardless of previous treatment .

###24816936
OBJECTIVE	To determine inter-observer and inter-examination variability for aortic valve calcification ( AVC ) and mitral valve and annulus calcification ( MC ) in low-dose unenhanced ungated lung cancer screening chest computed tomography ( CT ) .
METHODS	We included 578 lung cancer screening trial participants who were examined by CT twice within 3 months to follow indeterminate pulmonary nodules .
METHODS	On these CTs , AVC and MC were measured in cubic millimetres .
METHODS	One hundred CTs were examined by five observers to determine the inter-observer variability .
METHODS	Reliability was assessed by kappa statistics ( ) and intra-class correlation coefficients ( ICCs ) .
METHODS	Variability was expressed as the mean difference standard deviation ( SD ) .
RESULTS	Inter-examination reliability was excellent for AVC ( = 0.94 , ICC = 0.96 ) and MC ( = 0.95 , ICC = 0.90 ) .
RESULTS	Inter-examination variability was 12.7118.2 mm ( 3 ) for AVC and 31.5219.2 mm ( 3 ) for MC .
RESULTS	Inter-observer reliability ranged from = 0.68 to = 0.92 for AVC and from = 0.20 to = 0.66 for MC .
RESULTS	Inter-observer ICC was 0.94 for AVC and ranged from 0.56 to 0.97 for MC .
RESULTS	Inter-observer variability ranged from -30.5252.0 mm ( 3 ) to 84.0240.5 mm ( 3 ) for AVC and from -95.2210.0 mm ( 3 ) to 303.7501.6 mm ( 3 ) for MC .
CONCLUSIONS	AVC can be quantified with excellent reliability on ungated unenhanced low-dose chest CT , but manual detection of MC can be subject to substantial inter-observer variability .
CONCLUSIONS	Lung cancer screening CT may be used for detection and quantification of cardiac valve calcifications .
CONCLUSIONS	Low-dose unenhanced ungated chest computed tomography can detect cardiac valve calcifications .
CONCLUSIONS	However , calcified cardiac valves are not reported by most radiologists .
CONCLUSIONS	Inter-observer and inter-examination variability of aortic valve calcifications is sufficient for longitudinal studies .
CONCLUSIONS	Volumetric measurement variability of mitral valve and annulus calcifications is substantial .

###24706338
OBJECTIVE	To assess whether physical activity is a risk factor for amyotrophic lateral sclerosis ( ALS ) .
METHODS	From February 2008 to April 2012 , 652 patients with ALS from European population-based registries ( France , Ireland , Italy , United Kingdom , Serbia ) and 1,166 population controls ( matched for age , sex , and residency ) were assessed .
METHODS	Upon direct interview , data were collected on occupation and history of sport and leisure activities , physical activity , and accidental injuries .
METHODS	Physical exercise was defined as having spent time doing activities that caused an individual to breath hard at least once per month and was coded as none , job-related , and/or sport-related .
METHODS	Sport-related and work-related physical exercise were quantified using metabolic equivalents ( METs ) .
METHODS	Risks were calculated using conditional logistic regression models ( adjusting for age , country , trauma , and job-related physical activity ) and expressed as odds ratios ( ORs ) and adjusted ORs ( Adj ORs ) with 95 % confidence intervals ( CIs ) .
RESULTS	Overall physical activity was associated with reduced odds of having ALS ( Adj OR = 0.65 , 95 % CI = 0.48-0 .89 ) as were work-related physical activity ( Adj OR = 0.56 , 95 % CI = 0.36-0 .87 ) and organized sports ( Adj OR = 0.49 , 95 % CI = 0.32-0 .75 ) .
RESULTS	An inverse correlation was observed between ALS , the duration of physical activity ( p = 0.0041 ) , and the cumulative MET scores , which became significant for the highest exposure ( Adj OR = 0.34 , 95 % CI = 0.21-0 .54 ) .
RESULTS	An inverse correlation between ALS and sport was found in women but not in men , and in subjects with repeated traumatic events .
CONCLUSIONS	Physical activity is not a risk factor for ALS and may eventually be protective against the disease .

###25262346
BACKGROUND	Patients with schizophrenia are characterized by high prevalence rates and chronicity that often leads to long-term institutionalization .
BACKGROUND	Under the traditional medical model , treatment usually emphasizes the management of psychotic symptoms through medication , even though anti-psychotic drugs are associated with severe side effects , which can diminish patients ' physical and psychological well-being .
BACKGROUND	Tai-chi , a mind-body exercise rooted in Eastern health philosophy , emphasizes the motor coordination and relaxation .
BACKGROUND	With these potential benefits , a randomized controlled trial ( RCT ) is planned to investigate the effects of Tai-chi intervention on the cognitive and motor deficits characteristic of patients with schizophrenia .
METHODS	A 3-arm RCT with waitlist control design will be used in this study .
METHODS	One hundred and fifty three participants will be randomized into ( i ) Tai-chi , ( ii ) exercise or ( iii ) waitlist control groups .
METHODS	Participants in both the Tai-chi and exercise groups will receive 12-weeks of specific intervention , in addition to the standard medication and care received by the waitlist control group .
METHODS	The exercise group will serve as a comparison , to delineate any unique benefits of Tai-chi that are independent of moderate aerobic exercise .
METHODS	All three groups will undergo three assessment phases : ( i ) at baseline , ( ii ) at 12 weeks ( post-intervention ) , and ( iii ) at 24 weeks ( maintenance ) .
METHODS	All participants will be assessed in terms of symptom management , motor coordination , memory , daily living function , and stress levels based on self-perceived responses and a physiological marker .
CONCLUSIONS	Based on a promising pilot study conducted prior to this RCT , subjects in the Tai-chi intervention group are expected to be protected against deterioration of motor coordination and interpersonal functioning .
CONCLUSIONS	They are also expected to have better symptoms management and lower stress level than the other treatment groups .
BACKGROUND	The trail has been registered in the Clinical Trials Center of the University of Hong Kong ( HKCTR-1453 ) .

###24618443
BACKGROUND	Pancreatic exocrine insufficiency is a significant problem after acute pancreatitis .
OBJECTIVE	To evaluate whether oral pancreatic enzyme supplementation improves the recovery of pancreatic exocrine function and to explore the efficacy , safety and tolerability of pancreatic enzyme supplementation in patients during the refeeding period after acute pancreatitis .
METHODS	Prospective double-blind , placebo controlled , randomized study .
METHODS	The sudy included 56 patients with acute pancreatitis .
METHODS	Primary efficacy variable was recovery from pancreatic exocrine insufficiency .
METHODS	Secondary objectives were body weight , abdominal pain , course of APACHE II score , patient 's symptoms and quality of life .
RESULTS	Twenty of the 56 patients showed low fecal elastase values indicating pancreatic exocrine insufficiency after acute pancreatitis .
RESULTS	Median time to recovery from exocrine pancreatic insufficiency was 14 days in the enzyme supplementation group and 23 days in the placebo group but overall differences for primary and all but one secondary endpoint did not reach statistical significance .
RESULTS	However , a positive tendency in favour of enzyme supplementation was found for quality of life parameters ( FACT-Pa ) in all subscores .
RESULTS	There were no relevant differences between placebo and oral pancreatic enzyme supplementation detected with respect to safety and tolerability .
CONCLUSIONS	Enzyme supplementation positively effects the course of acute pancreatitis if administered during the early refeeding phase after acute pancreatitis .
CONCLUSIONS	There is evidence that oral pancreatic enzyme supplementation has a positive impact on the course of the disease and the global health status ( less weight loss , less flatulence , improved quality of life ) .
CONCLUSIONS	Oral pancreatic enzyme supplementation was safely administered and can be added to the treatment regimen of patients in a refeeding status after severe acute pancreatitis .

###25125055
BACKGROUND	Incisional pain is the main obstacle for elective laparoscopic cholecystectomy as an outpatient .
BACKGROUND	We evaluated the analgesic efficacy of local infiltration of ropivacaine with dexamethasone ( Rop/Dx ) , compared with ropivacaine ( Rop ) alone , during the first 24 hours postoperative of this surgery .
BACKGROUND	Our hypothesis is that incisional pain intensity will be lower in patients of the group Rop/Dx .
METHODS	In a randomized , controlled , double-blind trial clinical , 80 patients were divided into two groups .
METHODS	Group Rop ( n = 40 ) received pre and post-incisional infiltration with 150 mg of ropivacaine in 8 mL of 0.9 % saline , while group Rop/Dx ( n = 40 ) received 150 mg of ropivacaine with 8 mg of dexamethasone in 6 mL of 0.9 % saline .
METHODS	The intensity of pain at rest and movement was assessed at 2 , 4 , 8 , 12 and 24 hours postoperatively by a numerical rating scale of 11 points .
RESULTS	Incisional pain scores in group Rop/Dx were significantly lower , compared to the group Rop , at 12 hours ( p = 0.05 ) and 24 hours ( p = 0.01 ) at rest and at 12 hours ( p = 0.04 ) and 24 hours ( p = 0.01 ) during movement postoperatively .
CONCLUSIONS	We found initial evidence that ropivacaine with dexamethasone for local infiltration decreased incisional pain intensity after 12 hours post-elective laparoscopic cholecystectomy with a good safety profile .

###24679469
BACKGROUND	IL-23 expression is increased in psoriatic lesions and might regulate TH17 T-cell counts in patients with psoriasis .
OBJECTIVE	We sought to test a novel IL-23-specific therapeutic agent for the treatment of psoriasis .
METHODS	In this randomized , double-blind , placebo-controlled study the safety , tolerability , and clinical response of guselkumab , an anti-IL-23-specific mAb , were evaluated in patients with moderate-to-severe plaque psoriasis .
METHODS	A total of 24 patients were randomized to receive a single dose of placebo or 10 , 30 , 100 , or 300 mg of guselkumab .
METHODS	Clinical response was assessed by using the Psoriasis Area and Severity Index ( PASI ) .
METHODS	Additionally , histologic analysis and gene expression in skin biopsy specimens from guselkumab-treated patients were compared with those from placebo-treated patients .
RESULTS	At week 12 , 50 % ( 10 mg ) , 60 % ( 30 and 100 mg ) , and 100 % ( 300 mg ) of guselkumab-treated patients , respectively , achieved a 75 % improvement in PASI scores from baseline compared with 0 % of placebo-treated patients .
RESULTS	Improvements in PASI scores were generally maintained through week 24 in all guselkumab-treated patients .
RESULTS	The proportion of patients experiencing an adverse event was comparable between the combined guselkumab ( 13/20 [ 65.0 % ] ) and placebo ( 2/4 [ 50.0 % ] ) groups through week 24 .
RESULTS	Analysis of lesional and nonlesional skin biopsy specimens demonstrated decreases in epidermal thickness and T-cell and dendritic cell expression in guselkumab-treated patients compared with values seen in placebo-treated patients .
RESULTS	At week 12 , significant reductions in psoriasis gene expression and serum IL-17A levels were observed in guselkumab-treated patients .
CONCLUSIONS	IL-23 inhibition with a single dose of guselkumab results in clinical responses in patients with moderate-to-severe psoriasis , suggesting that neutralization of IL-23 alone is a promising therapy for psoriasis .

###25113081
BACKGROUND	Stroke leads to transient immunedepression , which leads to increased incidence of poststroke infections .
BACKGROUND	Because infection is one of the most common causes of increased mortality in patients with stroke , this study was undertaken to document immunedepression after stroke in our population .
METHODS	A case-controlled study wherein 39 patients with acute ischemic stroke in the age group of 18 and 60 years without any evidence of previous immunedepression were included .
METHODS	Interleukin 6 ( IL-6 ) and interleukin 10 ( IL-10 ) levels were checked in plasma in both the groups on day 3 and day 45 .
METHODS	Also Cortisol and epinephrine levels were checked in the urine samples collected on day 3 and day 8 .
RESULTS	No significant difference was seen between the IL-6 and the IL-10 levels in samples collected on day 3 between the controls and cases , whereas Cortisol and norepinephrine were significantly raised in samples collected on day 3 in cases who developed infection as compared with controls .
CONCLUSIONS	The higher levels of urinary cortisol and norepinephrine were observed in patients with stroke who developed infections , which indirectly reflected increased amount of stroke related stress .
CONCLUSIONS	Furthermore , the levels of plasma IL-6 and IL-10 were also elevated in the same group of patients , which means transformation of immunecompetence to immunedepression , which is responsible for higher mortality .
CONCLUSIONS	Subsequently on recovery from infection the plasma levels of interleukins and urinary cortisol and norepinephrine did not show any difference , which indirectly means recovery of the immune system on recovery from acute stage of stroke .
CONCLUSIONS	Mortality in the patients with infection was increased than controls .

###24359514
BACKGROUND	Variations in ` slope ' ( how steep or flat the ground is ) may be good for health .
BACKGROUND	As walking up hills is a physiologically vigorous physical activity and can contribute to weight control , greater neighbourhood slopes may provide a protective barrier to weight gain , and help prevent Type 2 diabetes onset .
BACKGROUND	We explored whether living in ` hilly ' neighbourhoods was associated with diabetes prevalence among the Australian adult population .
METHODS	Participants ( 25 years ; n = 11,406 ) who completed the Western Australian Health and Wellbeing Surveillance System Survey ( 2003-2009 ) were asked whether or not they had medically-diagnosed diabetes .
METHODS	Geographic Information Systems ( GIS ) software was used to calculate a neighbourhood mean slope score , and other built environment measures at 1600 m around each participant 's home .
METHODS	Logistic regression models were used to predict the odds of self-reported diabetes after progressive adjustment for individual measures ( i.e. , age , sex ) , socioeconomic status ( i.e. , education , income ) , built environment , destinations , nutrition , and amount of walking .
RESULTS	After full adjustment , the odds of self-reported diabetes was 0.72 ( 95 % CI 0.55-0 .95 ) and 0.52 ( 95 % CI 0.39-0 .69 ) for adults living in neighbourhoods with moderate and higher levels of slope , respectively , compared with adults living in neighbourhoods with the lowest levels of slope .
RESULTS	The odds of having diabetes was 13 % lower ( odds ratio 0.87 ; 95 % CI 0.80-0 .94 ) for each increase of one percent in mean slope .
CONCLUSIONS	Living in a hilly neighbourhood may be protective of diabetes onset or this finding is spurious .
CONCLUSIONS	Nevertheless , the results are promising and have implications for future research and the practice of flattening land in new housing developments .

###25534957
BACKGROUND	The triage of human papillomavirus ( HPV ) - positive women is needed to avoid overreferral to colposcopy .
BACKGROUND	p16 ( INK4a ) immunostaining is an efficient triage method .
BACKGROUND	p16 ( INK4a ) / Ki-67 dual staining was introduced mainly to increase reproducibility and specificity compared with stand-alone p16 ( INK4a ) staining .
METHODS	Within a pilot project , HPV-positive women were referred to colposcopy if cytology was abnormal or unsatisfactory or HPV testing was still positive after 1 year .
METHODS	For 500 consecutive women , a slide obtained during colposcopy was immunostained for p16 ( INK4a ) / Ki-67 and independently interpreted by 7 readers without previous experience with dual staining .
METHODS	Four of these readers were experts in cervical pathology and 3 were not .
METHODS	Kappa values for multiple raters , sensitivity , and specificity for cervical intraepithelial neoplasia type 2-positive histology were computed .
METHODS	Because women with normal cytology were underrepresented , estimates for all HPV-positive women were obtained as weighted means of cytology-specific estimates .
RESULTS	The overall kappa for HPV-positive women was 0.70 ( 95 % confidence interval [ 95 % CI ] , 0.60-0 .77 ) .
RESULTS	Kappa values were not found to be significantly different between expert and nonexpert readers with regard to cervical cytology but were significantly increased ( P = .
RESULTS	0066 ) after consensus discussion .
RESULTS	The overall specificity estimate for HPV-positive women was 64.0 % ( 95 % CI , 57.4 % -70.2 % ) : 66.7 % ( 95 % CI , 59.8 % -73.0 % ) for experts and 60.5 % ( 95 % CI , 59.8 % -73.0 % ) for nonexperts .
RESULTS	Among women with abnormal cytology , the sensitivity was 85.5 % ( 95 % CI , 77.9 % -90.8 % ) : 85.8 % ( 95 % CI , 77.9 % -91.2 % ) for experts and 85.1 % ( 95 % CI , 76.6 % -90.9 % ) for nonexperts .
CONCLUSIONS	p16 ( INK4a ) / Ki-67 immunostaining demonstrated good reproducibility and specificity when triaging HPV-positive women .
CONCLUSIONS	Dual-staining interpretation can be performed , after short training , even by staff who are not experts in cervical cytology .
CONCLUSIONS	This allows HPV-based screening with triage to be performed in settings in which such expert staff is not available .

###24355961
OBJECTIVE	The primary objective of the following study is to determine and secondary objective is to compare the efficacy and safety of 5 % amlexanox oral paste in the treatment of recurrent minor aphthous ulcers and also to evaluate the recurrence rate of aphthous ulcers over a period of 1 year .
METHODS	The present study was conducted on 100 patients diagnosed to have recurrent minor aphthous ulcers of which , 50 patients were advised to apply 5 % amlexanox oral paste directly on the ulcer 4 times a day for 6 days and the other 50 patients were given placebo paste for the same duration .
METHODS	The baseline parameters were recorded on the first visit which includes ulcer size , pain , erythema and exudation .
METHODS	Efficacy and safety evaluations were made on the 4 th day and 6 th day .
METHODS	In total 30 patients with increased frequency of ulcers were advised to use 5 % amlexanox paste for one whole year and the number of ulcers per month was recorded to evaluate any decrease in the recurrence rate .
RESULTS	Male patients dominated the study with 73 males and 27 females .
RESULTS	The mean age of the total sample was 26.6 years .
RESULTS	The amlexanox group showed marked reduction in ulcer size ( P < 0.001 ) , significant reduction in the visual analog scale scores of pain ( P < 0.001 ) , significant lower scores of erythema and exudation ( P < 0.001 ) when compared to the placebo group on the 6 th day of follow-up .
RESULTS	The incidence of recurrence of ulcers was significantly reduced up to the 6 th month , but thereafter recurrence rate slowly increased .
CONCLUSIONS	Almost 5 % of Amlexanox oral paste is clinically beneficial in reducing the pain , erythema , exudation and size of the ulcer over a period of 6 days .
CONCLUSIONS	There was no definite conclusion drawn with respect to its effect on the recurrence rate of aphthous ulcers over a period of 1 year .

###24786013
OBJECTIVE	To compare the pharmacokinetic profiles and to assess bioequivalence of a newly developed orally soluble film formulation of sildenafil , taken without water , with those of a conventional formulation of sildenafil .
METHODS	This study was conducted in a population of healthy subjects as an open-label , randomized sequence , two-period , two-formulation , single-dose , crossover design .
METHODS	The subjects were randomly assigned to 1 of 2 sequences of the two formulations : an orally soluble film ( OSF ) of 50 mg sildenafil as the test drug and a film-coated tablet ( FCT ) of 50 mg sildenafil as the reference drug .
METHODS	Blood samples were collected at intervals from 0 to 24 hours after administration .
METHODS	Plasma concentrations of sildenafil and its active metabolite N-desmethyl sildenafil were analyzed using a liquid chromatography/tandem mass spectrometry method .
RESULTS	48 healthy male subjects completed the study .
RESULTS	The geometric mean ( CV % ) for Cmax in the OSF and FCT formulations were 267.21 ( 4.68 % ) ng/mL and 285.97 ( 5.32 % ) ng/mL , respectively .
RESULTS	The geometric mean for AUClast in the OSF and FCT formulations were 664.48 ( 4.40 % ) ng x h/mL and 647.96 ( 4.63 % ) ng x h/mL , respectively .
RESULTS	The geometric mean for AUCinf in the OSF and FCT formulations were 685.65 ( 4.37 % ) ng x h/mL and 666.28 ( 4.60 % ) ng x h / mL , respectively .
RESULTS	The 90 % confidence intervals of the ratios of the geometric means of the Cmax , AUClast , and AUCinf were 0.844 - 1.030 , 0.961 - 1.091 , and 0.965 - 1.093 , respectively .
CONCLUSIONS	The OSF sildenafil formulation exhibited no significant differences in its pharmacokinetics compared with those of the FCT formulation .
CONCLUSIONS	Therefore this convenient OSF sildenafil formulation , which can be taken without the need for water or chewing , offers physicians a novel and attractive treatment option for men with erectile dysfunction .
CONCLUSIONS	* These authors contributed equally to this work .

###25051839
OBJECTIVE	To explore the efficacy , mechanism and safety of silibinin combined with Ruangan pills ( a Chinese herbal preparation ) in the treatment of schistosomiasis liver fibrosis .
METHODS	A total of 200 patients with schistosomiasis liver fibrosis were randomly divided into a control group and a treatment group , and 100 patients in each group were respectively administered with oral silibinin alone and oral silibinin combined with Ruangan pills , respectively .
METHODS	The curative effects in the two groups were evaluated in 3 months , 6 months , 9 months and 12 months respectively .
RESULTS	The common five clinical symptoms of schistosomiasis liver fibrosis patients significantly relieved in the treatment group 12 months after the therapy , and the total efficiency reached more than 75 % , which were significantly higher than that in the control group .
RESULTS	In the treatment group and the control group , there was no improvement in the liver B ultrasonic classification 3 months and 6 months after the therapy ( P > 0.05 ) ; however , in 9 months and 12 months , the liver B ultrasonic classification in the treatment group was better than that in the control group ( P < 0.05 , P < 0.01 , respectively ) .
RESULTS	For the four serum indexes of liver fibrosis , there was no significant differences between the two groups in 3 months , however , in 6 months , 9 months , and 12 months , there was a significant improvement in the treatment group compared with the control group .
RESULTS	There were no obviously adverse effects in two groups .
CONCLUSIONS	Silibinin combined with Ruangan pills has a better curative effect in the treatment of schistosomiasis liver fibrosis .

###24532969
BACKGROUND	Airway inflammation persists after smoking cessation in established chronic obstructive pulmonary disease ( COPD ) , suggesting that other factors drive the airway inflammatory response .
OBJECTIVE	We tested the hypothesis that high levels of bacterial colonization are associated with increased levels of neutrophilic airway inflammation in stable COPD by examining the cross-sectional relationship between these measurements and by conducting a randomized , double-blind , placebo-controlled study of the effect of levofloxacin in patients with stable COPD .
METHODS	Patients were randomized to receive either levofloxacin 500 mg daily or placebo for 7 days and underwent sputum induction for a differential cell count and quantitative bacterial analysis at baseline and at days 7 , 14 , and 28 .
RESULTS	Sputum percentage neutrophil count correlated with airway bacterial load at baseline ( r = 0.56 ; P = 0.003 ) .
RESULTS	Levofloxacin reduced bacterial load compared with placebo by 4.9-fold ( 95 % confidence interval , 1.4-25 .7 ; P = 0.02 ) at day 7 but had no effect at any point on any marker of neutrophilic airway inflammation .
RESULTS	In patients with a baseline bacterial load of more than 10 ( 6 ) cfu/mL , levofloxacin treatment was associated with a 26.5 % ( 95 % confidence interval , 1.8 % -51.3 % ; P = 0.04 ) greater reduction in the percentage neutrophil count compared with placebo at day 7 .
RESULTS	Change in percentage neutrophil count correlated significantly with baseline airway bacterial load and change in airway bacterial load .
CONCLUSIONS	In stable COPD , levofloxacin treatment causes a short-term reduction in bacterial load .
CONCLUSIONS	This is associated with a reduction in neutrophilic airway inflammation in patients with high bacterial loads .
CONCLUSIONS	Further studies are required to investigate whether this effect is clinically advantageous .

###25133962
OBJECTIVE	To broaden the ethnic groups in which tapentadol IR is evaluated for treating acute postoperative pain to include Asians .
METHODS	In this phase 3 , multicenter , double-blind , randomized study , 352 Korean adults with moderate-to-severe pain following hallux valgus surgery received tapentadol IR 50 or 75 mg or placebo orally every 4-6 hours for 72 hours .
METHODS	Patients requesting other ( rescue ) analgesics during this period were discontinued for lack of efficacy .
METHODS	The primary endpoint , sum of pain intensity difference ( SPID ) over 48 hours , was evaluated based on the difference between tapentadol IR and placebo in least squares ( LS ) mean change from baseline using analysis of covariance ( ANCOVA ) .
METHODS	Secondary endpoints included the time to first rescue medication use and the distribution of responder rates .
RESULTS	A treatment effect , favoring tapentadol IR , was observed for SPID48 ( p < 0.001 for both doses vs. placebo , ANCOVA ) .
RESULTS	The between-group difference ( vs. placebo ) in LS means of SPID48 was 76.4 ( 95 % CI : 51.0 , 101.7 ) for tapentadol IR 50 mg and 90.6 ( 95 % CI : 65.1 , 116.1 ) for tapentadol IR 75 mg .
RESULTS	Time to first rescue medication use was delayed for tapentadol IR ( p < 0.001 for both doses vs. placebo ; log-rank test ) .
RESULTS	The distribution of responders at 12 , 24 , 48 , and 72 hours favored tapentadol IR ( p 0.001 for both doses vs. placebo ; Cochran-Mantel-Haenszel test ) .
RESULTS	Dizziness , nausea , and vomiting were each reported in 10 % tapentadol-treated patients and at an incidence 2-fold higher vs. placebo .
RESULTS	The study findings may be limited by study drug dosing every 4 to 6 hours and frequent monitoring during treatment , neither of which mimic pain treatment in clinical practice .
RESULTS	However , any potential bias based on this systematic monitoring of patients would be mitigated by the randomized , double-blind nature of the study , with all treatment groups similarly affected by such biases , if any .
CONCLUSIONS	Tapentadol IR reduced acute pain intensity , significantly more than placebo , after orthopedic surgery in Korean patients .
BACKGROUND	NCT01516008 .

###24773179
BACKGROUND	Renal fibrosis is common in progressive kidney disease .
BACKGROUND	Transforming growth factors ( TGF - ) are important mediators of all types of fibrosis , including renal fibrosis .
BACKGROUND	Chinese rhubarb has been shown to have antifibrotic properties in part because of inhibition of TGF - and has slowed the progression of kidney disease in rodent models .
OBJECTIVE	That administration of a Chinese rhubarb supplement will slow the progression of chronic kidney disease ( CKD ) in cats and the concurrent administration of Chinese rhubarb and benazepril will be more effective than either alone .
METHODS	Twenty-nine client-owned cats with naturally occurring IRIS Stage 2 or early Stage 3 CKD and without comorbidity such as cancer , urinary tract obstruction , urinary tract infection , poorly controlled hyperthyroidism , or systemic hypertension were enrolled in the study .
METHODS	A randomized , positive-controlled , prospective study was performed .
METHODS	Cats received Chinese rhubarb , benazepril , or both in addition to standard treatment for CKD .
METHODS	Repeated measures ANOVA was used to assess changes in serum creatinine concentration , body weight , hematocrit , urine protein : urine creatinine ratio ( UPC ) , and systemic arterial blood pressure over time between and within treatment groups over an average of 22 months .
RESULTS	No significant differences were detected in serum creatinine concentration , body weight , hematocrit , UPC , and systemic arterial pressure over time between or within treatment groups .
CONCLUSIONS	This study failed to detect a significant difference in the progression of CKD in cats treated with Chinese rhubarb , benazepril , or both .
CONCLUSIONS	Further study in specific subsets of cats with CKD is warranted .

###24265181
BACKGROUND	We hypothesized that the combination of nebivolol and lifestyle modification would reduce large artery stiffness in middle-aged and older hypertensive adults more than either intervention alone .
METHODS	To address this , 45 men and women ( age 40-75 years ) with stage I hypertension were randomized to receive either nebivolol ( NB ; forced titration to 10 mg OD ; n = 15 ; age 57.2 11.4 years ; body mass index [ BMI ] 30.8 5.8 kg/m ( 2 ) ) , lifestyle modification ( LM ; 5-10 % weight loss via calorie restriction and physical activity ; n = 15 ; age 52.7 8.5 years ; BMI 33.9 7.2 kg/m ( 2 ) ) or nebivolol plus lifestyle modification ( NBLM ; n = 15 ; age 58.9 9.4 years ; BMI 32.5 4.9 kg/m ( 2 ) ) for 12 weeks .
METHODS	- stiffness index , a blood-pressure-independent measure of arterial stiffness , and arterial compliance were measured via high-resolution ultrasound and tonometry at baseline and after the 12-week intervention .
METHODS	There was no difference between groups in age , body weight or composition , blood pressure , or in - stiffness index or arterial compliance at baseline ( all p > 0.05 ) .
RESULTS	Following the 12-week intervention , body weight decreased ~ 5 % ( p < 0.05 ) in the LM and NBLM groups but did not change from baseline in the NB group ( p > 0.05 ) .
RESULTS	Supine brachial and carotid systolic and diastolic blood pressure declined following treatment in each of the groups ( p < 0.05 ) .
RESULTS	However , the magnitude of reduction was not different ( p < 0.05 ) between groups .
RESULTS	- stiffness index declined ( -2.03 0.60 , -1.87 0.83 and -2.51 0.90 U ) and arterial compliance increased similarly ( both p > 0.05 ) in the NB , LM and NBLM groups , respectively .
CONCLUSIONS	In summary , our findings indicate that the combination of nebivolol and lifestyle modification reduced large artery stiffness to a similar degree as either intervention alone in middle-aged and older hypertensive adults .

###24241487
OBJECTIVE	To evaluate the longterm safety of adalimumab administered with or without methotrexate ( MTX ) and compare the efficacy of combination therapy initialization to adalimumab or MTX monotherapy initialization during the open-label extension ( OLE ) of the PREMIER trial ( ClinicalTrials.gov Identifier : NCT00195663 ) .
METHODS	Patients with early rheumatoid arthritis ( RA ) were randomized to receive blinded adalimumab + MTX , adalimumab alone , or MTX alone for 2 years .
METHODS	Following the double-blinded period , patients enrolling in the OLE were given adalimumab for up to 8 additional years , beginning as monotherapy ; investigators could add MTX at their discretion .
METHODS	Results for clinical , functional , and radiographic progression were collected for up to 10 years of treatment .
RESULTS	During the PREMIER OLE , 250/497 patients ( 50.3 % ) completed the trial without new safety signals arising .
RESULTS	Similar proportions of patients discontinued the trial early , although lack of efficacy was reported less often for patients initially randomized to the adalimumab + MTX arm ( 9.3 % ; 21.2 % , and 23.7 % for adalimumab and MTX monotherapies , respectively ) .
RESULTS	Clinical and functional disease control was maintained throughout the trial .
RESULTS	Patients initially randomized to adalimumab + MTX displayed better outcomes , particularly in prevention of radiographic progression ( modified total Sharp score change = 4.0 , 8.8 , 11.0 at Year 10 for the initial adalimumab + MTX , adalimumab , and MTX arms , respectively ) .
CONCLUSIONS	Intensive therapy with adalimumab + MTX combination in patients with early RA has longterm benefits compared to patients initiating with 2-year adalimumab or MTX monotherapy that persists up to 10 years following adalimumab OLE .
CONCLUSIONS	No new safety findings were observed following longterm adalimumab treatment .

###25171023
OBJECTIVE	There has been a marked decrease in the eradication rates of Helicobacter pylori infection with standard triple therapy worldwide .
OBJECTIVE	Hence , sequential therapy has gained attention as a promising treatment during the last few years .
OBJECTIVE	This study was carried out to compare the efficacy of sequential versus standard triple therapy in the context of clarithromycin ( CLA ) resistance .
METHODS	In this study , children between 3 and 18 years of age , who had documented H. pylori infection , were randomized to receive either standard triple or sequential therapy .
METHODS	H. pylori eradication was ascertained using the C-urea breath test 4-6 weeks after the completion of the treatment .
METHODS	Real-time PCR was performed on gastric biopsy samples for assessment of CLA resistance .
RESULTS	In all , 148 children ( median age : 12.183.51 years ) were recruited randomly into the study .
RESULTS	The intention-to-treat eradication rates were 50 % ( 37/74 ) for the sequential treatment group and 52.7 % ( 39/74 ) for the standard triple treatment group ( P = 0.87 ) .
RESULTS	A total of 136 children completed the study .
RESULTS	The per-protocol eradication rates were 56 % ( 37/66 ) and 55.7 % ( 39/70 ) for sequential and standard triple therapy groups , respectively .
RESULTS	CLA resistance was assessed and 113 children were included in the final analysis .
RESULTS	Of 113 participants , 53 were in the sequential treatment group and 60 were in the standard triple treatment group .
RESULTS	The success rates of the respective therapies ( 29/53 = 54.7 % in sequential , 33/60 = 55 % in standard therapy ) were similar ( P = 0.98 ) .
RESULTS	CLA resistance was detected in 29 ( 25.7 % ) of the patients .
RESULTS	Eradication rates with sequential therapy in CLA susceptible and resistant cases were 60.5 % ( 23/38 ) and 40 % ( 6/15 ) , respectively ( P = 0.23 ) .
RESULTS	The corresponding figures for the standard triple treatment group were 63 % ( 29/46 ) and 28.6 % ( 4/14 ) ( P = 0.033 ) .
RESULTS	Although a higher eradication rate was observed in CLA-resistant cases with sequential therapy , the difference did not reach statistical significance ( P = 0.69 ) .
CONCLUSIONS	In this study , standard triple treatment failed to eradicate H. pylori infection in the majority of the children , and sequential therapy offered only a small advantage over standard triple therapy in the eradication of CLA-resistant strains .

###24533896
BACKGROUND	Patients with heartburn but without esophageal erosion respond less well to proton pump inhibitors ( PPIs ) .
BACKGROUND	There is a growing body of evidence implicating the role of psychological comorbidities in producing reflux symptoms .
BACKGROUND	Pain modulators improve symptoms in patients with other functional gastrointestinal disorders .
BACKGROUND	We aimed to compare the efficacy of fluoxetine with omeprazole and placebo to achieve symptomatic relief in patients with heartburn and normal endoscopy who failed once daily PPIs .
METHODS	Endoscopy-negative patients with heartburn who failed once daily PPIs were randomly allocated to receive 6weeks treatment of fluoxetine , omeprazole , or placebo .
METHODS	Random allocation was stratified according to ambulatory pH monitoring study .
METHODS	Percentage of heartburn-free days and symptom severity was assessed .
RESULTS	Sixty patients with abnormal and 84 patients with normal pH test were randomized .
RESULTS	Subjects receiving fluoxetine experienced more improvement in percentage of heartburn-free days ( median 35.7 , IQR 21.4-57 .1 ) than those on omeprazole ( median 7.14 , IQR 0-50 , p < 0.001 ) or placebo ( median 7.14 , IQR 0-33 .6 , p < 0.001 ) .
RESULTS	In normal pH subgroup , fluoxetine was superior to both omeprazole and placebo regarding percentage of heartburn-free days ( median improvement , 57.1 , IQR 35.7-57 .1 vs 13.9 , IQR , 0-45 .6 and 7.14 , 0-23 .8 , respectively , p < 0.001 ) , but no significant difference was observed between medications in abnormal pH subgroup .
CONCLUSIONS	Fluoxetine was superior to omeprazole for improving the symptoms of patients with heartburn and normal endoscopy who failed once daily PPIs .
CONCLUSIONS	The superiority of fluoxetine was mostly attributed to those with normal esophageal pH rather than those with abnormal pH ( ClinicalTrials.gov , number NCT01269788 ) .

###25239650
BACKGROUND	Chronic hemodynamically relevant pulmonary regurgitation ( PR ) resulting in important right ventricular dilation and ventricular dysfunction is commonly seen after tetralogy of Fallot ( TOF ) repair .
BACKGROUND	Late adverse clinical outcomes , including exercise intolerance , arrhythmias , heart failure and/or death accelerate in the third decade of life and are cause for considerable concern .
BACKGROUND	Timing of pulmonary valve replacement ( PVR ) to address chronic PR is controversial , particularly in asymptomatic individuals , and effect of PVR on clinical measures has not been determined .
METHODS	Canadian Outcomes Registry Late After Tetralogy of Fallot Repair ( CORRELATE ) is a prospective , multicentre , Canada-wide cohort study .
METHODS	Candidates will be included if they are 12 years of age , have had surgically repaired TOF resulting in moderate or severe PR , and are able to undergo cardiovascular magnetic resonance imaging .
METHODS	Enrollment of > 1000 individuals from 15 participating centres ( Toronto , Montreal , Quebec City , Sherbrooke , Halifax , Calgary , Edmonton , and Vancouver ) is anticipated .
METHODS	Clinical data , health-related quality of life metrics , and adverse outcomes will be entered into a web-based database .
METHODS	A central core lab will analyze all cardiovascular magnetic resonance studies ( PR severity , right ventricular volumes , and ventricular function ) .
METHODS	Major adverse outcomes ( sustained ventricular tachycardia and cardiovascular cause of death ) will be centrally adjudicated .
RESULTS	To the best of our knowledge , CORRELATE will be the first prospective pan-Canadian cohort study of congenital heart disease in children and adults .
CONCLUSIONS	CORRELATE will uniquely link clinical , imaging , and functional data in those with repaired TOF and important PR , thereby enabling critical evaluation of clinically relevant outcomes in those managed conservatively compared with those referred for PVR .

###24742217
BACKGROUND	A randomized controlled trial evaluated the effect of telephone-based peer support on preventing postpartum depression ( PPD ) among high-risk mothers .
BACKGROUND	The results indicated that support provided by peer volunteers may be an effective preventative strategy .
BACKGROUND	The purpose of this paper is to outline the process of developing , implementing , maintaining , and evaluating the peer support program that we used in this PPD prevention trial .
METHODS	The peer support program had been used successfully in a pilot trial and a previous breastfeeding peer support trial .
METHODS	Based on our experience and lessons learned , we developed a 4-phase , 12-step approach so that the peer support model could be copied and used by different health providers in various settings .
METHODS	We will use the PPD prevention trial to demonstrate the suggested steps .
RESULTS	The trial aim to prevent the onset of PPD was established .
RESULTS	Peer volunteers who previously experienced and recovered from self-reported PPD were recruited and attended a four-hour training session .
RESULTS	Volunteers were screened and those identified as appropriate to provide support to postpartum mothers were selected .
RESULTS	Women who scored more than 9 on the Edinburgh Postnatal Depression Scale within the first two weeks after childbirth were recruited to participate in the trial and proactive , individualized , telephone-based peer support ( mother-to-mother ) was provided to those randomized to the intervention group .
RESULTS	Peer volunteers maintained the intervention , supported other volunteers , and evaluated the telephone-based support program .
RESULTS	Possible negative effects of the intervention were assessed .
RESULTS	An in-depth assessment of maternal perspectives of the program at 12weeks postpartum was performed .
CONCLUSIONS	The 4-phase , 12-step approach delineated in this paper provides clear and concise guidelines for health professionals to follow in creating and implementing community-based , peer-support interventions with the potential to prevent PPD .
BACKGROUND	Current Controlled Trials ISRCTN68337727 .

###24731917
BACKGROUND	Many women experience emotional distress , depression and anxiety after a diagnosis of breast cancer .
BACKGROUND	Psychological stress and depression have been associated with hypothalamic-pituitary-adrenal ( HPA ) axis dysregulation that may adversely affect immune system functioning and impact upon survival .
BACKGROUND	This study investigated the effects of a lifestyle intervention on indices of psychological health status , HPA axis regulation and immune function in overweight women recovering from early-stage breast cancer treatment .
METHODS	A total of 85 women treated for breast cancer 3 to 18 months previously were randomly allocated to a 6-month exercise and hypocaloric healthy eating program plus usual care or usual care alone ( control group ) .
METHODS	Women in the intervention group received three supervised exercise sessions per week and individualized dietary advice , supplemented by weekly nutrition seminars .
METHODS	Depressive symptoms ( Beck Depression Inventory version II : BDI-II ) , perceived stress ( Perceived Stress Scale : PSS ) , salivary diurnal cortisol rhythms ; inflammatory cytokines ( IL-6 and Tumor necrosis factor - ) , leukocyte phenotype counts , natural killer ( NK ) cell cytotoxicity and lymphocyte proliferation following mitogenic stimulation were assessed at baseline and 6-month follow up .
RESULTS	Compared with the control group , the intervention group exhibited a reduction in depressive symptoms ( adjusted mean difference , 95 % confidence intervals ( 95 % CI ) : -3.12 , -1.03 to -5.26 ; P = 0.004 ) at the 6-month follow-up but no significant decrease in PSS scores ( -2.07 , -4.96 to 0.82 ; P = 0.16 ) .
RESULTS	The lifestyle intervention also had a significant impact on diurnal salivary cortisol rhythm compared with usual care alone , as evidenced by an increase in morning salivary cortisol at the 6-month follow-up ( P < 0.04 ) , indicating a change in HPA axis regulation .
RESULTS	Women in the control group had higher total leukocyte , neutrophil and lymphocyte counts in comparison to the intervention group at the 6-month follow-up ( P 0.05 ) , whereas there was no difference in NK cell counts ( P = 0.46 ) , NK cell cytotoxicity ( P = 0.85 ) or lymphocyte proliferation responses ( P = 0.11 ) between the two groups .
CONCLUSIONS	Our results show that the lifestyle intervention resulted in a reduction in depressive symptoms and a normalisation of HPA axis regulation .
CONCLUSIONS	Such changes could have important implications for long-term survival in women recovering from early-breast cancer treatment .
BACKGROUND	Current Controlled Trials : ISRCTN08045231 .

###24378144
OBJECTIVE	To evaluate the effectiveness of an intervention based on motivational interviewing to reduce medication errors in chronic patients over 65 with polypharmacy .
METHODS	Cluster randomized trial that included doctors and nurses of 16 Primary Care centers and chronic patients with polypharmacy over 65 years .
METHODS	The professionals were assigned to the experimental or the control group using stratified randomization .
METHODS	Interventions consisted of training of professionals and revision of patient treatments , application of motivational interviewing in the experimental group and also the usual approach in the control group .
METHODS	The primary endpoint ( medication error ) was analyzed at individual level , and was estimated with the absolute risk reduction ( ARR ) , relative risk reduction ( RRR ) , number of subjects to treat ( NNT ) and by multiple logistic regression analysis .
RESULTS	Thirty-two professionals were randomized ( 19 doctors and 13 nurses ) , 27 of them recruited 154 patients consecutively ( 13 professionals in the experimental group recruited 70 patients and 14 professionals recruited 84 patients in the control group ) and completed 6 months of follow-up .
RESULTS	The mean age of patients was 76 years ( 68.8 % women ) .
RESULTS	A decrease in the average of medication errors was observed along the period .
RESULTS	The reduction was greater in the experimental than in the control group ( F = 5.109 , P = .035 ) .
RESULTS	RRA 29 % ( 95 % confidence interval [ 95 % CI ] 15.0-43 .0 % ) , RRR 0.59 ( 95 % CI :0.31 -0.76 ) , and NNT 3.5 ( 95 % CI 2.3-6 .8 ) .
CONCLUSIONS	Motivational interviewing is more efficient than the usual approach to reduce medication errors in patients over 65 with polypharmacy .

###24333376
BACKGROUND	Repeated nicotine exposure causes neuroadaptations in limbic cortico-striatal circuits involved in learning and motivation .
BACKGROUND	Such alterations are relevant to addiction because they are suggested to mediate the ability of smoking-associated stimuli to control behavior and to enhance nicotine-seeking and - taking behaviors .
BACKGROUND	Female smokers report higher cue reactivity relative to their male counter parts , yet little is known about putative gender-specific effects of adolescent nicotine exposure on reward-related learning .
BACKGROUND	Prior repeated nicotine exposure in adult male rats enhances Pavlovian approach behavior and conditioned reinforcement .
OBJECTIVE	Given that smoking is typically initiated during adolescence , here we assessed the extent to which adolescent nicotine exposure impacts Pavlovian approach and conditioned reinforcement in male and female rats .
METHODS	Rats were injected with nicotine on postnatal days 31-45 prior to training on Pavlovian approach behavior starting on day 51 .
METHODS	They were trained to associate a conditioned stimulus ( CS ) , illumination of a magazine light , and tone , with an unconditioned stimulus ( US ) , the delivery of water , for 10-daily sessions , and then were tested on the acquisition of responding with conditioned reinforcement .
RESULTS	Adolescent nicotine exposure selectively increased approach to the magazine during the CS in males but decreased approach to the magazine during the CS in female rats .
RESULTS	Vehicle-exposed female rats , however , showed greater magazine approach during the CS than did male control rats .
RESULTS	Prior nicotine exposure also enhanced conditioned reinforcement in both male and female rats .
CONCLUSIONS	Repeated exposure to nicotine during adolescence had opposite effects on Pavlovian approach behavior in male and female rats but enhanced acquisition of a new response with conditioned reinforcement .
CONCLUSIONS	Novel information on how nicotine exposure influences reward-related learning during adolescence may increase our understanding of neurobiological mechanisms involved in the initiation of smoking behavior .

###25641533
BACKGROUND	Target vessel revascularization ( TVR ) may compromise the benefits of primary percutaneous coronary intervention in ST-segment elevation myocardial infarction ( STEMI ) We set out to identify the predictors and examine the impact of TVR after STEMI in patients receiving a coronary stent .
METHODS	In HORIZONS-AMI , 3,602 patients with STEMI were randomized to bivalirudin versus heparin and a glycoprotein IIb/IIIa inhibitor .
METHODS	Stents were implanted in 3,202 patients ( 2,982 were randomized to bare-metal stents versus paclitaxel-eluting stents , and 220 received nonrandomized stents ) .
RESULTS	Target vessel revascularization occurred in 219 patients ( 6.9 % ) at 1 year and in 437 patients ( 14.4 % ) at 3 years .
RESULTS	Target vessel revascularization was ischemia-driven in 418 cases ( 95.7 % ) .
RESULTS	Target vessel revascularization was due to restenosis in 219 patients ( 50.1 % ) , definite stent thrombosis in 124 ( 28.4 % ) , and disease progression in 94 ( 21.5 % ) .
RESULTS	Independent predictors of TVR were more extensive coronary artery disease , smaller vessel size , longer lesion length and the number of stents implanted , post-percutaneous coronary intervention diameter stenosis , symptom onset to balloon time , treatment with bare-metal stents rather than paclitaxel-eluting stents , and scheduled angiographic follow-up .
RESULTS	Target vessel revascularization was an independent predictor of subsequent myocardial infarction ( hazard ratio [ HR ] 5.25 , P < .0001 ) , ST ( HR 5.98 , P < .0001 ) , and major bleeding ( HR 5.25 , P < .0001 ) but not mortality ( HR 0.88 , P = .61 ) .
CONCLUSIONS	In HORIZONS-AMI , TVR within 3 years after stent implantation was performed in ~ 1 of every 7 patients and was associated with more extensive coronary disease , more complex procedures , and bare metal stents .
CONCLUSIONS	Target vessel revascularization was often due to stent thrombosis and disease progression as well as restenosis and was strongly associated with adverse outcomes but not mortality .

###25210025
OBJECTIVE	To determine the effect of ranolazine , an anti-ischaemic agent with anti-arrhythmic properties , on the overall burden of atrial fibrillation ( AF ) in acute coronary syndromes ( ACS ) and determine whether ranolazine reduces the long-term incidence of clinical AF after ACS .
RESULTS	MERLIN-TIMI 36 randomized patients with non-ST elevation ACS to ranolazine or placebo .
RESULTS	Atrial fibrillation episodes detected on continuous electrocardiogram ( cECG ) monitoring were reviewed in 6351 patients ( 97 % of trial ) .
RESULTS	Atrial fibrillation burden was categorized according to the time in AF : clinically insignificant AF ( < 0.01 % of time ) , paroxysmal AF ( > 0.01-98 % ) , or predominantly persistent AF ( > 98 % ) .
RESULTS	Clinical AF events were identified through adverse event reporting for a median 1-year follow-up .
RESULTS	Overall , patients assigned to ranolazine had a trend towards fewer episodes of AF [ 75 ( 2.4 % ) vs. 55 ( 1.7 % ) patients , P = 0.08 ] detected on cECG during the first 7 days after randomization .
RESULTS	The pattern of new-onset AF differed between ranolazine vs. placebo : clinically insignificant AF ( five patients in ranolazine vs. seven in placebo ) , paroxysmal AF ( 18 vs. 48 patients ) , and predominantly chronic AF ( 28 vs. 20 patients , three-way P < 0.01 ) .
RESULTS	Among patients with a paroxysmal AF pattern , the overall burden was lower with ranolazine than with placebo ( median 4.4 vs. 16.1 % , P = 0.015 ) .
RESULTS	Over the median 1-year follow-up , fewer patients treated with ranolazine experienced an AF event compared with placebo ( 2.9 vs. 4.1 % , RR 0.71 , P = 0.01 ) .
CONCLUSIONS	Ranolazine , an anti-anginal agent with electrophysiological effects , may reduce the frequency of paroxysmal AF in patients with non-ST elevation ACS with a pattern of lower overall AF burden in this group .
CONCLUSIONS	Ranolazine reduced the overall 1-year incidence of clinical AF events .
CONCLUSIONS	These atrial-specific anti-arrhythmic properties of ranolazine may be of clinical interest and warrant additional investigation .
BACKGROUND	NCT00099788 .

###25381560
BACKGROUND	The incidence of cardiovascular disease ( CVD ) in rheumatoid arthritis ( RA ) is increased compared to the general population .
BACKGROUND	Immune dysregulation and systemic inflammation are thought to be associated with this increased risk .
BACKGROUND	Early diagnosis with immediate treatment and tight control of RA forms a central treatment paradigm .
BACKGROUND	It remains unclear , however , whether using tumor necrosis factor inhibitors ( TNFi ) to achieve remission confer additional beneficial effects over standard therapy , especially on the development of CVD .
METHODS	Coronary Artery Disease Evaluation in Rheumatoid Arthritis ( CADERA ) is a prospective cardiovascular imaging study that bolts onto an existing single-centre , randomized controlled trial , VEDERA ( Very Early versus Delayed Etanercept in Rheumatoid Arthritis ) .
METHODS	VEDERA will recruit 120 patients with early , treatment-nave RA , randomized to TNFi therapy etanercept ( ETN ) combined with methotrexate ( MTX ) , or therapy with MTX with or without additional synthetic disease modifying anti-rheumatic drugs with escalation to ETN following a ` treat-to-target ' regimen .
METHODS	VEDERA patients will be recruited into CADERA and undergo cardiac magnetic resonance ( CMR ) assessment with ; cine imaging , rest/stress adenosine perfusion , tissue-tagging , aortic distensibility , T1 mapping and late gadolinium imaging .
METHODS	Primary objectives are to detect the prevalence and change of cardiovascular abnormalities by CMR between TNFi and standard therapy over a 12-month period .
METHODS	All patients will enter an inflammatory arthritis registry for long-term follow-up .
CONCLUSIONS	CADERA is a multi-parametric study describing cardiovascular abnormalities in early , treatment-nave RA patients , with assessment of changes at one year between early biological therapy and conventional therapy .
BACKGROUND	This trial was registered with Current Controlled Trials ( registration number : ISRCTN50167738 ) on 8 November 2013 .

###26173554
OBJECTIVE	To evaluate the effectiveness of efforts to translate and disseminate evidence-based guidelines about atypical antipsychotic use to nursing homes ( NHs ) .
METHODS	Three-arm , cluster randomized trial .
METHODS	NHs .
METHODS	NHs in the state of Connecticut .
METHODS	Evidence-based guidelines for atypical antipsychotic prescribing were translated into a toolkit targeting NH stakeholders , and 42 NHs were recruited and randomized to one of three toolkit dissemination strategies : mailed toolkit delivery ( minimal intensity ) ; mailed toolkit delivery with quarterly audit and feedback reports about facility-level antipsychotic prescribing ( moderate intensity ) ; and in-person toolkit delivery with academic detailing , on-site behavioral management training , and quarterly audit and feedback reports ( high intensity ) .
METHODS	Outcomes were evaluated using the Reach , Effectiveness , Adoption , Implementation , Maintenance ( RE-AIM ) framework .
RESULTS	Toolkit awareness of 30 % ( 7/23 ) of leadership of low-intensity NHs , 54 % ( 19/35 ) of moderate-intensity NHs , and 82 % ( 18/22 ) of high-intensity NHs reflected adoption and implementation of the intervention .
RESULTS	Highest levels of use and knowledge among direct care staff were reported in high-intensity NHs .
RESULTS	Antipsychotic prescribing levels declined during the study period , but there were no statistically significant differences between study arms or from secular trends .
CONCLUSIONS	RE-AIM indicators suggest some success in disseminating the toolkit and differences in reach , adoption , and implementation according to dissemination strategy but no measurable effect on antipsychotic prescribing trends .
CONCLUSIONS	Further dissemination to external stakeholders such as psychiatry consultants and hospitals may be needed to influence antipsychotic prescribing for NH residents .

###25407695
BACKGROUND	An intervention trial of the ` SuperAmma ' village-level intervention to promote handwashing with soap ( HWWS ) in rural India demonstrated substantial increases in HWWS amongst the target population .
BACKGROUND	We carried out a process evaluation to assess the implementation of the intervention and the evidence that it had changed the perceived benefits and social norms associated with HWWS .
BACKGROUND	The evaluation also aimed to inform the design of a streamlined shorter intervention and estimate scale up costs .
METHODS	Intervention implementation was observed in 7 villages .
METHODS	Semi-structured interviews were conducted with the implementation team , village leaders and representatives of the target population .
METHODS	A questionnaire survey was administered in 174 households in intervention villages and 171 households in control villages to assess exposure to intervention activities , recall of intervention components and evidence that the intervention had produced changes in perceptions that were consistent with the intervention core messages .
METHODS	Costs were estimated for the intervention as delivered , as well as for a hypothetical scale-up to 1,000 villages .
RESULTS	We found that the intervention was largely acceptable to the target population , maintained high fidelity ( after some starting problems ) , and resulted in a high level of exposure to most components .
RESULTS	There was a high recall of most intervention activities .
RESULTS	Subjects in the intervention villages were more likely than those in control villages to cite reasons for HWWS that were in line with intervention messaging and to believe that HWWS was a social norm .
RESULTS	There were no major differences between socio-economic and caste groups in exposure to intervention activities .
RESULTS	Reducing the intervention from 4 to 2 contact days , in a scale up scenario , cut the estimated implementation cost from $ 2,293 to $ 1,097 per village .
CONCLUSIONS	The SuperAmma intervention is capable of achieving good reach across men and women of varied social and economic status , is affordable , and has the potential to be effective at scale , provided that sufficient attention is given to ensuring the quality of intervention delivery .

###24943673
BACKGROUND	Recent trials demonstrate the acceptability and short term efficacy of primary care referral to a commercial weight loss provider for weight management .
BACKGROUND	Commissioners now need information on the optimal duration of intervention and the longer term outcomes and cost effectiveness of such treatment to give best value for money .
METHODS	This multicentre , randomised controlled trial with a parallel design will recruit 1200 overweight adults ( BMI 28kg/m2 ) through their primary care provider .
METHODS	They will be randomised in a 2:5:5 allocation to : Brief Intervention , Commercial Programme for 12weeks , or Commercial Programme for 52weeks .
METHODS	Participants will be followed up for two years , with assessments at 0 , 3 , 12 and 24months .
METHODS	The sequential primary research questions are whether the CP interventions achieve significantly greater weight loss from baseline to 12months than BI , and whether CP52 achieves significantly greater weight loss from baseline to 12months than CP12 .
METHODS	The primary outcomes will be an intention to treat analysis of between treatment differences in body weight at 12months .
METHODS	Clinical effectiveness will be also be assessed by measures of weight , fat mass , and blood pressure at each time point and biochemical risk factors at 12months .
METHODS	Self-report questionnaires will collect data on psychosocial factors associated with adherence , weight-loss and weight-loss maintenance .
METHODS	A within-trial and long-term cost-effectiveness analysis will be conducted from an NHS perspective .
METHODS	Qualitative methods will be used to examine the participant experience .
CONCLUSIONS	The current trial compares the clinical and cost effectiveness of referral to a commercial provider with a brief intervention .
CONCLUSIONS	This trial will specifically examine whether providing longer weight-loss treatment without altering content or intensity ( 12months commercial referral vs. 12weeks ) leads to greater weight loss at one year and is sustained at 2years .
CONCLUSIONS	It will also evaluate the relative cost-effectiveness of the three interventions .
CONCLUSIONS	This study has direct implications for primary care practice in the UK and will provide important information to inform the decisions of practitioners and commissioners about service provision .
BACKGROUND	Current Controlled Trials ISRCTN82857232 .
BACKGROUND	Date registered : 15/10/2012 .

###25626750
BACKGROUND	Recent studies suggest that self-explanation ( SE ) while diagnosing cases fosters the development of clinical reasoning in medical students ; however , the conditions that optimise the impact of SE remain unknown .
BACKGROUND	The example-based learning framework justifies an exploration of students ' use of their own SEs combined with the study of examples .
BACKGROUND	This study aimed to assess the impact on medical students ' diagnostic performance of : ( i ) combining students ' SEs with their listening to examples of residents ' SEs , and ( ii ) the addition of prompts ( specific questions ) while working with examples .
METHODS	This study consisted of a training phase and an assessment phase conducted 1 week later .
METHODS	In the training phase , 54 Year 3 medical students were randomly assigned to one of three groups .
METHODS	In all groups , students first solved four clinical cases using SE .
METHODS	Subsequently , Group 1 listened to examples of residents ' SEs with prompts ; Group 2 listened to examples of residents ' SEs without prompts , and the control group solved word puzzles .
METHODS	Then , all students again solved the same four cases .
METHODS	One week later , all students solved four similar and four different cases .
METHODS	Students ' diagnostic performance and diagnostic accuracy scores were assessed for each case at each time-point .
RESULTS	Although all groups ' diagnostic accuracy scores on similar cases improved significantly between the training and the assessment phase , Group 1 showed a significantly higher diagnostic performance score after 1 week than the control group ( p = 0.037 ) .
RESULTS	On different cases , Group 1 obtained significantly higher diagnostic accuracy ( p = 0.011 ) and diagnostic performance ( p < 0.001 ) scores than the control group and a significantly higher diagnostic performance score than Group 2 ( p = 0.018 ) .
CONCLUSIONS	Self-explanation seems to be an effective technique to help medical students learn clinical reasoning .
CONCLUSIONS	Its impact is increased significantly by combining it with examples of residents ' SEs and prompts .
CONCLUSIONS	Although students ' exposure to examples of clinical reasoning is important , their ` active processing ' of these examples appears to be critical to their learning from them .

###24829088
OBJECTIVE	To evaluate the effect of modulating pouch emptying ( PE ) and SI transit of glucose after Roux-en-Y gastric bypass ( RYGB ) on blood glucose , incretin hormones , glucose absorption and gastrointestinal ( GI ) symptoms .
METHODS	Ten RYGB patients were studied twice in random order , receiving either a 150 ml glucose drink ( 200 kcal ) or the same solution infused into the proximal Roux-limb at 4 kcal/min .
METHODS	Data were compared with 10 healthy volunteers who received a 4 kcal/min duodenal infusion .
METHODS	PE , cecal arrival time ( CAT ) , blood glucose , plasma 3-O-methylglucose ( 3-OMG ) , insulin , glucose-dependent insulinotropic polypeptide ( GIP ) , and glucagon-like peptide-1 ( GLP-1 ) , and GI symptoms were measured .
RESULTS	In RYGB subjects , the glucose drink emptied very rapidly ( PE t50 = 31 min ) and intestinal glucose infusion was associated with higher blood glucose and plasma 3-OMG , but lower plasma GLP-1 , GIP , insulin , and GI symptoms than oral glucose ( all P < 0.001 ) , and comparable to volunteers .
RESULTS	In RYGB subjects , CAT correlated inversely with peak GLP-1 ( r = -0.73 , P = 0.01 ) , and plasma 3-OMG correlated tightly blood glucose ( r = 0.94 , P < 0.0001 ) .
CONCLUSIONS	After RYGB , reducing intestinal glucose delivery to 4 kcal/min is associated with higher blood glucose , greater glucose absorption , lower incretin responses , and less GI symptoms , supporting rapid transit contribution to the exaggerated incretin responses and `` dumping symptoms '' .

###25499546
BACKGROUND	Vitamin A supplementation in children aged 6 months to 5 years has been shown to reduce mortality .
BACKGROUND	The efficacy of neonatal supplementation with vitamin A to reduce mortality in the first 6 months of life is plausible but not established .
BACKGROUND	We aimed to assess the efficacy of neonatal oral supplementation with vitamin A to reduce mortality between supplementation and 6 months of age .
METHODS	We undertook an individually randomised , double-blind , placebo-controlled trial in Haryana , India .
METHODS	We identified pregnant women through a surveillance programme undertaken every 3 months of all female residents in two districts of Haryana , India , aged 15-49 years , and screened every identified livebirth .
METHODS	Eligible participants were neonates whose parents consented to participate , were likely to stay in the study area until at least 6 months of age , and were able to feed orally at the time of enrolment .
METHODS	Participants were randomly assigned to receive oral capsules containing vitamin A ( retinol palmitate 50,000 IU plus vitamin E 95-126 IU ) or placebo ( vitamin E 95-126 IU ) within 72 h of birth .
METHODS	Randomisation was in blocks of 20 according to a randomisation list prepared by a statistician not otherwise involved with the trial .
METHODS	Investigators , participants ' families , and the data analysis team were masked to treatment allocation .
METHODS	The primary outcome was mortality between supplementation and 6 months of age .
METHODS	Analysis included all participants assigned to study groups .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01138449 , and the Indian Council of Medical Research Clinical Trial Registry , number CTRI/2010/091 / 000220 .
RESULTS	Between June 24 , 2010 , and July 1 , 2012 we screened 47,777 neonates and randomly assigned 44,984 to receive vitamin A ( 22,493 ) or placebo ( 22,491 ) .
RESULTS	Between supplementation and 6 months of age , 656 infants died in the vitamin A group compared with 726 in the placebo group ( 292 per 1000 vs 323 per 1000 ; difference -31 per 1000 , 95 % CI -63 to 01 ; risk ratio 090 , 95 % CI 081 to 100 ) .
RESULTS	We noted no significant interactions between the intervention effect and sex on mortality at 6 months ( p = 0409 ) .
RESULTS	Supplementation with 50,000 IU vitamin A within the first 72 h of life was generally safe and well tolerated , with the exception of a small excess risk of transient bulging fontanelle ( 205 cases in the vitamin A group confirmed by physician vs 80 cases in the placebo group , risk ratio 256 [ 95 % CI 198-332 ] ) .
CONCLUSIONS	The findings of this study , done in a population in which vitamin A deficiency is a moderate public health problem , are consistent with a modest reduction in mortality between supplementation and 6 months of age .
CONCLUSIONS	These findings must be viewed together with similar trials in other populations to enable determination of appropriate public health policy .
BACKGROUND	Bill & Melinda Gates Foundation to WHO .

###25561787
OBJECTIVE	To undertake a randomised pilot study comparing biodegradable stents and endoscopic dilatation in patients with strictures .
METHODS	This British multi-site study recruited seventeen symptomatic adult patients with refractory strictures .
METHODS	Patients were randomised using a multicentre , blinded assessor design , comparing a biodegradable stent ( BS ) with endoscopic dilatation ( ED ) .
METHODS	The primary endpoint was the average dysphagia score during the first 6 mo. .
METHODS	Secondary endpoints included repeat endoscopic procedures , quality of life , and adverse events .
METHODS	Secondary analysis included follow-up to 12 mo. .
METHODS	Sensitivity analyses explored alternative estimation methods for dysphagia and multiple imputation of missing values .
METHODS	Nonparametric tests were used .
RESULTS	Although both groups improved , the average dysphagia scores for patients receiving stents were higher after 6 mo : BS-ED 1.17 ( 95 % CI : 0.63-1 .78 ) P = 0.029 .
RESULTS	The finding was robust under different estimation methods .
RESULTS	Use of additional endoscopic procedures and quality of life ( QALY ) estimates were similar for BS and ED patients at 6 and 12 mo. .
RESULTS	Concomitant use of gastrointestinal prescribed medication was greater in the stent group ( BS 5.1 , ED 2.0 prescriptions ; P < 0.001 ) , as were related adverse events ( BS 1.4 , ED 0.0 events ; P = 0.024 ) .
RESULTS	Groups were comparable at baseline and findings were statistically significant but numbers were small due to under-recruitment .
RESULTS	The oesophageal tract has somatic sensitivity and the process of the stent dissolving , possibly unevenly , might promote discomfort or reflux .
CONCLUSIONS	Stenting was associated with greater dysphagia , co-medication and adverse events .
CONCLUSIONS	Rigorously conducted and adequately powered trials are needed before widespread adoption of this technology .

###24747504
OBJECTIVE	Memantine hydrochloride ( Memary ) , launched in June 2011 in Japan , is used in patients with moderate to severe Alzheimer 's disease .
OBJECTIVE	We performed an integrated analysis of data obtained from different clinical studies of memantine hydrochloride conducted between 2002 and 2011 in Japan in order to examine the long-term tolerability and efficacy of this drug at a dose of 20 mg/day .
METHODS	Using clinical studies of memantine hydrochloride performed in Japan between 2002 and 2011 , the therapeutic safety and the time course of MMSE scores in 702 subjects who had received memantine hydrochloride were examined .
RESULTS	The mean duration of memantine treatment was 798.1 days , with the longest duration of 3,373 days ( approximately nine years and two months ) .
RESULTS	The incidence of adverse events every 52 weeks of treatment ranged from 71.0 % to 88.9 % , and the incidence of adverse drug reactions ranged from 5.6 % to 32.1 % , with no associations between the incidence of adverse events and the treatment duration .
RESULTS	There were no adverse drug reactions specific to the long-term administration of this drug .
RESULTS	The occurrence of `` adverse events '' was the primary reason for drug discontinuation .
RESULTS	During the long-term study observation period , there were many cases of adverse events and treatment discontinuation due to the background factors of the subjects , including adverse events associated with aging and progression of the underlying conditions .
RESULTS	In addition , treatment discontinuation was also associated with admission to a nursing home or facility due to changes in home nursing care .
RESULTS	The degree of MMSE score reduction over time was lower in the patients treated with memantine than the expected MMSE score reduction observed in the untreated patients .
CONCLUSIONS	Based on these findings , there are no issues regarding the tolerability of memantine hydrochloride administered at a dose of 20 mg/day over the long term .
CONCLUSIONS	Considering changes in the MMSE score , the results indicated that memantine hydrochloride may inhibit worsening of the cognitive function for long periods of time in patients with Alzheimer 's disease .

###24631129
OBJECTIVE	Evaluate the efficacy and tolerability of ITCA 650 in subjects with type 2 diabetes treated for up to 48 weeks .
METHODS	This was a 24-week extension to a randomized , 24-week , open-label , phase 2 study in subjects with type 2 diabetes inadequately controlled with metformin .
METHODS	Subjects received ITCA 650 mg ( 20 , 40 , 60 or 80 g/day ) .
METHODS	Mean changes for HbA1c , weight , and fasting plasma glucose ( FPG ) were evaluated .
RESULTS	Mean changes in HbA1c from baseline to week 48 ranged from -0.85 % to -1.51 % .
RESULTS	At week 48 , 64 % of subjects with an HbA1c 7 % at week 24 maintained an HbA1c 7 % .
RESULTS	The incidence of adverse events ( AEs ) was dose-related and ranged from 13.3 % with 20 g/day to 37.5 % with 80 g/day .
RESULTS	Most AEs were mild and transient ; the incidence of nausea declined from 12.9 % to 9.5 % over the 24-week extension .
RESULTS	One subject on ITCA 650 80 g/day experienced mild intermittent vomiting .
RESULTS	Three ( 3.5 % ) subjects experienced severe AEs , but none were considered related to study drug .
CONCLUSIONS	Significant changes in HbA1c , body weight , and FPG attained with ITCA 650 were maintained to 48 weeks .
CONCLUSIONS	The incidence of AEs was lower in the 24-week extension than in the initial 24-week treatment phase .

###25649801
OBJECTIVE	Although several randomized controlled trials failed to show a benefit of B vitamin therapy on composite outcomes of cardiovascular death , myocardial infarction , and stroke among individuals with elevated homocysteine , recent post hoc analyses have suggested that several factors may interact with the effects of vitamin treatment .
OBJECTIVE	One post hoc analysis revealed an interaction between B vitamin therapy and antiplatelet use ; however , those results have not been replicated in other studies or populations .
METHODS	We conducted a post hoc analysis of the Vitamin Intervention for Stroke Prevention ( VISP ) trial , a randomized controlled trial evaluating treatment with high - versus low-dose B vitamin therapy for secondary prevention of vascular events among stroke survivors with elevated homocysteine .
METHODS	Cox regression models were used to assess primary ( recurrent stroke ) and secondary ( stroke , myocardial infarction , or vascular death ) outcomes among individuals on high - versus low-dose vitamin therapy , categorized by antiplatelet use , after adjusting for covariates .
RESULTS	Among 3680 participants , 52 % took antiplatelet medications .
RESULTS	When compared with low-dose therapy , high-dose vitamin therapy was associated with higher stroke risk among individuals on antiplatelets ( hazard ratio , 1.43 ; 95 % confidence interval , 1.02-2 .01 ) , but trended toward lower risk among those not on antiplatelets ( hazard ratio , 0.86 ; 95 % confidence interval , 0.62-1 .19 ) .
CONCLUSIONS	High-dose B vitamin therapy may be associated with a higher risk of recurrent stroke among stroke survivors taking antiplatelets , but does not have a significant effect on recurrent stroke risk in those who are not on antiplatelets .
CONCLUSIONS	Future randomized controlled trials may consider evaluating the effect of homocysteine lowering among stroke survivors with elevated homocysteine who are not on antiplatelet therapy .

###24972949
OBJECTIVE	To clarify the immunogenicity and safety of influenza vaccine in patients with end-stage kidney disease ( ESKD ) on dialysis or who have received a kidney transplant .
METHODS	Sixty adolescents and young adults with ESKD ( 25 on hemodialysis and 35 kidney transplant recipients ) were randomized 1:1 to receive a traditional trivalent split virion vaccine ( TIIV ) or a virosome-adjuvanted trivalent inactivated influenza vaccine ( VATIIV ) .
METHODS	The immunogenicity and safety of the two vaccines was evaluated and compared with the findings observed in 30 healthy subjects of similar age and gender distribution who received TIIV .
RESULTS	The results indicate that the immune response of the patients to TIIV and VATIIV were similar .
RESULTS	The administered vaccines were safe and well tolerated , and no advantage was found with the use of VATIIV .
CONCLUSIONS	Given the potential clinical relevance of influenza in patients with ESKD , these findings support the official recommendation that they should receive annual influenza vaccinations .

###25459391
OBJECTIVE	To investigate the efficacy and safety of gemcitabine and platinum salt , with or without trastuzumab , in patients with locally advanced or metastatic urothelial carcinoma overexpressing Her2 .
METHODS	The main eligibility criterion was Her2 overexpression on immunohistochemistry ( IHC 2 + or 3 + ) of primary tumour tissue confirmed by fluorescence in situ hybridisation ( FISH ) .
METHODS	Patients were randomised to Arm A : gemcitabine 1000mg/m ( 2 ) ( days 1 and 8 ) plus either cisplatin ( 70mg/m ( 2 ) ) or carboplatin ( AUC = 5 ) ( day 1 every 3 weeks ) or Arm B : added trastuzumab ( 8mg/kg loading dose , then 6 mg/kg every 21 days until progression ) .
METHODS	The primary end-point was progression-free survival ( PFS ) .
RESULTS	Among 563 screened patients , 75 ( 13.3 % ) were Her2 positive ( IHC 2 + / 3 + and FISH + ) and 61 met all eligibility criteria ( median age , 64 years ; 54/61 males ; 50/61 baseline ECOG-PS 0-1 ; 11 locally advanced and 50 metastatic ) .
RESULTS	There was no significant difference between Arms A and B in median PFS ( 10.2 versus 8.2 months , respectively , p = 0.689 ) , objective response rate ( 65.5 % versus 53.2 % , p = 0.39 ) , and median overall survival ( 15.7 versus 14.1 months , respectively , p = 0.684 ) .
RESULTS	In an exploratory analysis , trastuzumab-treated patients receiving cisplatin rather than carboplatin-based chemotherapy fared better ( PFS : 10.6 versus 8.0 ; OS : 33.1 versus 9.5 months ) .
RESULTS	Myelosuppression was the main grade 3/4 toxicity .
RESULTS	A case of grade 3 cardiotoxicity and one death from febrile neutropenia occurred in arm B.
CONCLUSIONS	The unexpectedly low incidence of Her2 overexpression precluded the detection of a significant difference in efficacy on addition of trastuzumab to platinum-based chemotherapy with gemcitabine .
CONCLUSIONS	However , the satisfactory tolerance of the combination warrants further studies , especially of the cisplatin-based combination , in well-defined patient subsets .

###24457472
OBJECTIVE	To investigate the therapeutic effect and biological changes of hepatic arterial infusion of p53 gene by the percutaneous port catheter system on advanced hepatocellular carcinoma ( HCC ) through a prospective randomized trial .
METHODS	A total of 48 patients with advanced HCC between May 2005 and January 2009 were divided into the treatment group ( 30 ) and the control group ( 18 ) .
METHODS	The port catheter system was implanted through the right external iliac artery approach in all the cases ; the target artery was determined according to the manifestation of the angiograph .
METHODS	The patients in the treatment group were given arterial infusion of p53 gene ( Gendicine , Shenzhen Sibiono GeneTech Co , Ltd ) with Gendicine ( 10vp ) combined with hydroxycamptothecin ( 20 mg ) , once a week , for a course continuously for 3 weeks .
METHODS	The arterial infusion with hydroxycamptothecin ( 20 mg ) was given to the patients in the control group .
METHODS	Pretreatment/posttreatment a fetus protein and Karnofsky Performance Status values , change of tumor according to Response Evaluation Criteria in Solid Tumors ( RECIST ) , and the survival time were analyzed .
METHODS	Pretreatment/posttreatment expression of mutant p53 gene and spontaneous micronucleus formation in the peripheral blood were evaluated by flow cytometry and micronucleus test in vivo .
RESULTS	The patients in the treatment group received 1 to 8 courses of treatment , in which the differences between pretreatment/posttreatment AFP and KPS values were significant ( P < 0.05 ) , whereas there was no significant difference ( P > 0.05 ) between pretreatment/posttreatment AFP and KPS values within the control group .
RESULTS	After 1 month , the survival rates of the treatment and control groups ( 96.6 % and 94.4 % , respectively ) and changes in the tumor evaluated according to RECIST were significantly different ( P < 0.05 ) between the 2 groups .
RESULTS	After 3 months , the survival rates of the treatment and control groups ( 83.3 % and 55.6 % , respectively ) and changes in the tumor were also significantly different between the 2 groups ( P < 0.05 ) .
RESULTS	After 6 months , the survival rates ( 50 % and 11 % , respectively ) and changes in the tumor were significantly different between the 2 groups ( P < 0.05 ) .
RESULTS	After 9 months , the survival rates ( 23.3 % and 0 % , respectively ) and changes in the tumor were significantly different between the 2 groups ( P < 0.05 ) .
RESULTS	Finally , after 12 months , the survival rates ( 6.67 % and 0 % , respectively ) and changes in the tumor were significantly different between the 2 groups ( P < 0.05 ) .
RESULTS	The difference between the pretreatment and posttreatment mean rates of p53 expression in patients in the treatment group was very significant ( P < 0.01 ) .
RESULTS	The difference between the posttreatment mean rates of the treatment group and the control group was also significant .
CONCLUSIONS	Sequential therapy of p53 gene transcatheter arterial infusion was safe and could prolong the survival time of the patients .
CONCLUSIONS	The biological study will play a positive role in guiding and monitoring the aspects of dosage selection and judgment of therapeutic efficacy .

###26076572
BACKGROUND	The surgical treatment of hallux valgus deformity is connected with significant postoperative pain .
BACKGROUND	Spinal and general anesthesia as well as peripheral blocks are successfully used in foot surgery .
BACKGROUND	The purpose of this study was to evaluate the influence of local anesthetic infiltration before hallux valgus one-day surgery on postoperative pain and the need for analgesics .
METHODS	134 patients underwent chevron or miniinvasive Mitchell-Kramer osteotomy of the first distal metatarsal .
METHODS	After general anesthesia each patient randomly received an infiltration of 7ml of local anesthetic ( 4 ml of 0.25 % bupivacaine and 3 ml of 2 % lidocaine ) or the same amount of normal saline 15 minutes before the skin incision .
METHODS	Both the patient and the surgeon were blinded .
METHODS	The patient was discharged after approximately 2 hours of observation .
METHODS	2 , 4 , 8 , 12 , 16 , 24 and 72 hours after the release of the tourniquet the level of pain was assessed by the visual analogue scale ( VAS ) .
METHODS	Rescue analgesia , side effects and the use of painkillers were noted .
RESULTS	Preemptive local anesthetic infiltration significantly decreased pain during the first 24 hours after the surgery .
RESULTS	None of the patients from the injected group and 38 from the placebo group received 100 mg of ketoprofen intravenously for rescue analgesia in the first 2 hours after the release of the tourniquet .
RESULTS	During the first 24 hours we noted significantly decreased use of 1000 mg of paracetamol and 100 mg mg of ketoprofen orally in the injected group .
RESULTS	No systemic adverse effects were noted .
RESULTS	One patient from placebo group had allergic rush after use of 100 mg ketoprofen .
CONCLUSIONS	Preemptive local anesthetic infiltration in one-day hallux valgus surgery significantly decreases postoperative pain .
CONCLUSIONS	It is safe , efficient and allows fast discharge .

###25289930
OBJECTIVE	Trauma induces a state of immunosuppression , which is responsible for the development of nosocomial infections .
OBJECTIVE	Hydrocortisone reduces the rate of pneumonia in patients with trauma .
OBJECTIVE	Because alterations of dendritic cells and natural killer cells play a central role in trauma-induced immunosuppression , we investigated whether hydrocortisone modulates the dendritic cell/natural killer cell cross talk in the context of posttraumatic pneumonia .
METHODS	Experimental study .
METHODS	Research laboratory from an university hospital .
METHODS	Bagg Albino/cJ mice ( weight , 20-24 g ) .
METHODS	First , in an a priori substudy of a multicenter , randomized , double-blind , placebo-controlled trial of hydrocortisone ( 200 mg/d for 7 d ) in patients with severe trauma , we have measured the blood levels of five cytokines ( tumor necrosis factor - , interleukin-6 , interleukin-10 , interleukin-12 , interleukin-17 ) at day 1 and day 8 .
METHODS	In a second step , the effects of hydrocortisone on dendritic cell/natural killer cell cross talk were studied in a mouse model of posttraumatic pneumonia .
METHODS	Hydrocortisone ( 0.6 mg/mice i.p. ) was administered immediately after hemorrhage .
METHODS	Twenty-four hours later , the mice were challenged with Staphylococcus aureus ( 7 10 colony-forming units ) .
RESULTS	Using sera collected during a multicenter study in patients with trauma , we found that hydrocortisone decreased the blood level of interleukin-10 , a cytokine centrally involved in the regulation of dendritic cell/natural killer cell cluster .
RESULTS	In a mouse model of trauma-hemorrhage-induced immunosuppression , splenic natural killer cells induced an interleukin-10-dependent elimination of splenic dendritic cell .
RESULTS	Hydrocortisone treatment reduced this suppressive function of natural killer cells and increased survival of mice with posthemorrhage pneumonia .
RESULTS	The reduction of the interleukin-10 level in natural killer cells by hydrocortisone was partially dependent on the up-regulation of glucocorticoid-induced tumor necrosis factor receptor-ligand ( TNFsf18 ) on dendritic cell .
CONCLUSIONS	These data demonstrate that trauma-induced immunosuppression is characterized by an interleukin-10-dependent elimination of dendritic cell by natural killer cells and that hydrocortisone improves outcome by limiting this immunosuppressive feedback loop .

###24648506
OBJECTIVE	Oral amoxicillin ( 50 mg/kg/day ) thrice daily is the first-line therapy for non-severe childhood pneumonia .
OBJECTIVE	Compliance could be enhanced if two daily doses are employed .
OBJECTIVE	We assessed the equivalence of oral amoxicillin ( 50 mg/kg/day ) thrice or twice daily in those patients .
METHODS	This randomized ( 1:1 ) , controlled , triple-blinded investigation conducted at one centre in Brazil included children aged 2-59 months with non-severe pneumonia diagnosed by trained paediatricians based on respiratory complaints and radiographic pulmonary infiltrate/consolidation .
METHODS	Participants were randomly assigned to receive one bottle ( Amoxicillin 1 ) at 6 am , 2 pm and 10 pm and the other bottle ( Amoxicillin 2 ) at 8 am and 8 pm : one bottle contained amoxicillin and the other placebo and vice versa .
METHODS	Only the pharmacist knew patients ' allocation .
METHODS	Follow-up assessments were done at 2 , 5 and 14 days after enrolment .
METHODS	Chest radiographs were read by three independent radiologists .
METHODS	Primary outcome was treatment failure ( development of danger signs , persistence of fever , tachypnoea , development of serious adverse reactions , death and withdrawal from the trial ) at 48 h. ClinicalTrials.gov : identifier NCT01200706 .
RESULTS	Four hundred and twelve and 408 participants received amoxicillin thrice or twice daily , respectively .
RESULTS	Treatment failure was detected in 94 ( 22.8 % ) and 94 ( 23.0 % ) patients in intention-to-treat analysis ( risk difference 0.2 % ; 95 % CI : -5.5 % -6.0 % ) and in 80 ( 20.1 % ) and 85 ( 21.3 % ) patients in per-protocol analysis ( risk difference 1.2 % ; 95 % CI : -4.4 % -6.8 % ) .
RESULTS	Pneumonia was radiologically confirmed by concordant reading in 277 ( 33.8 % ) cases , among whom treatment failure was registered in 25/133 ( 18.8 % ) and 27/144 ( 18.8 % ) participants from the thrice and twice daily doses subgroups , respectively ( risk difference -0.05 % ; 95 % CI : -9.3 % -9.2 % ) .
CONCLUSIONS	Oral amoxicillin ( 50 mg/kg/day ) twice daily is as efficacious as thrice daily .

###26234838
OBJECTIVE	Transcatheter aortic valve implantation ( TAVI ) results in the dislodgement of debris with risk of cerebral lesions or stroke .
OBJECTIVE	The EMBOL-X protection device ( Edwards Lifesciences , Irvine , CA ) is positioned within the ascending aorta to capture such debris .
METHODS	Between July 2012 and April 2014 we randomly assigned 30 high-risk patientsto undergo transaortic TAVI with the SAPIEN XT prosthesis ( Edwards Lifesciences ) combined with either the EMBOL-X device ( group-1 , n = 14 ) or without ( group-2 , n = 16 ) .
METHODS	Periprocedural cerebral lesions were assessed by diffusion-weighted magnetic resonance imaging ( DW-MRI ) at baseline and within 7 days post-procedurally .
RESULTS	New foci of restricted diffusion on cerebral DW-MRI were found in 69 % in group-2 and 50 % in group-1 .
RESULTS	Lesion size was smaller in patients treated with the EMBOL-X device than in those without ( 88 60 vs 168 217 mm ( 3 ) , p = 0.27 , t = 1.2 , degrees of freedom = 10 ) .
RESULTS	Transaortic TAVI patients treated with the EMBOL-X device had significantly smaller lesion volumes in the supply region of the middle cerebral artery ( 33 29 vs 76 67 mm ( 3 ) , p = 0.04 ) .
RESULTS	There were no neurologic events after transaortic TAVI .
CONCLUSIONS	The intraaortic protection device seems to reduce both the incidence and the volume of new cerebral lesions ( ClinicalTrials.gov number , NCT01735513 ) .

###25070809
BACKGROUND	A functional polymorphism ( 5-HTTLPR ) in the promoter region of the serotonin transporter gene has been widely studied as a risk factor and moderator of treatment for a variety of psychopathologic conditions .
BACKGROUND	To evaluate whether 5-HTTLPR moderates the effects of treatment to reduce heavy drinking , we studied 112 high-functioning European-American men who have sex with men ( MSM ) .
BACKGROUND	Subjects participated in a randomized clinical trial of naltrexone ( NTX ) and cognitive behavioral therapy ( CBT ) for problem drinking .
METHODS	Subjects were treated for 12 weeks with 100 mg/d of oral NTX or placebo ( PBO ) .
METHODS	All participants received medical management with adjusted brief behavioral compliance enhancement treatment ( BBCET ) alone or in combination with modified behavioral self-control therapy ( MBSCT ; an amalgam of motivational interviewing and CBT ) .
METHODS	Participants were genotyped for the tri-allelic 5-HTTLPR polymorphism ( i.e. , low-activity S ' or high-activity L' alleles ) .
RESULTS	During treatment , the number of weekly heavy drinking days ( HDD ; defined as 5 or more standard drinks per day ) was significantly lower in subjects with the L' L' ( N = 26 , p = 0.015 ) or L 'S ' ( N = 52 , p = 0.016 ) genotype than those with the S 'S ' ( N = 34 ) genotype regardless of treatment type .
RESULTS	There was a significant interaction of genotype with treatment : For subjects with the S 'S ' genotype , the effects of MBSCT or NTX on HDD were significantly greater than the minimal intervention ( i.e. , BBCET or PBO , p = 0.007 and p = 0.049 , respectively ) .
RESULTS	In contrast , for subjects with 1 or 2 L' alleles , the effects of the more intensive psychosocial treatment ( MBSCT ) or NTX did not significantly differ from BBCET or PBO .
CONCLUSIONS	These preliminary findings support the utility of the 5-HTTLPR polymorphism for personalizing treatment selection in problem drinkers .

###25283252
BACKGROUND	Collagens have long been used in pharmaceuticals and food supplements for the improvement of skin .
OBJECTIVE	We evaluated the efficacy of high advanced-collagen tripeptide ( HACP ) on wound healing and skin recovery .
METHODS	Using an in vitro model , we performed HaCaT cell migration assays and collagen gel contraction assays using HACP concentrations of 1 , 10 and 100g/mL .
METHODS	In this pilot study , eight healthy volunteers were randomly divided into two groups .
METHODS	Both the control and experimental groups received fractional photothermolysis treatment , but in the experimental group , four subjects received 3g/day of oral collagen peptide ( CP ) for 4weeks .
METHODS	To assess transepidermal water loss in each patient before and after the treatment , we used a Corneometer and a Cutometer , and we also assessed the patient 's Erythema Index .
RESULTS	The cell migration assay showed that HACP enhanced wound closure , but not in a dose-dependent manner .
RESULTS	The collagen gel contraction assay showed increased contractility when patients were treated with 100g/mL HACP , but the results were not significantly different from those of controls .
RESULTS	We found that post-laser erythema resolved faster in the experimental group than in the control group ( P < 0.05 ) .
RESULTS	In addition , the recovery of skin hydration after fractional laser treatment was greater in the experimental group than in the control group by day 3 ( P < 0.05 ) , and the experimental group showed significantly improved post-treatment skin elasticity compared with the controls by day 14 ( P < 0.05 ) .
CONCLUSIONS	Collagen tripeptide treatment appears to be an effective and conservative therapy for cutaneous wound healing and skin recovery after fractional photothermolysis treatment .

###24595047
BACKGROUND	The natural history and manifestation of HIV-related neurologic disease have been ameliorated by combination antiretroviral therapy ( ART ) .
BACKGROUND	We describe the characteristics of white matter signal abnormalities ( WMSA ) on magnetic resonance imaging in children with HIV-related neurologic disease .
METHODS	We reviewed magnetic resonance imaging scans of children with suspected HIV-related neurologic disease despite early ART and correlated with clinical , neurodevelopmental data , virologic markers and time on ART .
METHODS	These children were also on the Children with HIV Early Antiretroviral ( CHER ) trial .
RESULTS	Magnetic resonance imaging scans were performed at a mean age 31.9 months ( range 8-54 ) on 44 children : 10 on deferred and 34 on early treatment arms , commencing ART at mean age of 18.5 and 8 weeks , respectively .
RESULTS	Multiple high signal intensity lesions on T2/fluid attenuated inversion recovery were documented in 22 patients ( 50 % ) , predominantly in frontal ( 91 % ) and parietal ( 82 % ) white matter .
RESULTS	No differences in neurodevelopmental scores comparing children with and without WMSA were found .
RESULTS	Neither lesion load nor distribution showed significant correlation with neurodevelopmental scores or neurologic examination .
RESULTS	Normal head growth was more common in the WMSA group ( P = 0.01 ) .
RESULTS	There was a trend for association of WMSA and longer time on ART ( P = 0.13 ) and nadir CD4 % ( P = 0.08 ) .
CONCLUSIONS	Half of children referred with HIV-related brain disease had WMSA on T2/fluid attenuated inversion recovery .
CONCLUSIONS	Our findings of the association with normal head growth and duration of ART require further study .
CONCLUSIONS	We suspect that WMSA can occur early and that initiating ART by 8 weeks of life may be too late to prevent HIV from entering the central nervous system .

###24239324
BACKGROUND	Primaquine is the only available drug that clears mature Plasmodium falciparum gametocytes in infected human hosts , thereby preventing transmission of malaria to mosquitoes .
BACKGROUND	However , concerns about dose-dependent haemolysis in people with glucose-6-phosphate dehydrogenase ( G6PD ) deficiencies have limited its use .
BACKGROUND	We assessed the dose-response association of single-dose primaquine for gametocyte clearance and for safety in P falciparum malaria .
METHODS	We undertook this randomised , double-blind , placebo-controlled trial with four parallel groups in Jinja district , eastern Uganda .
METHODS	We randomly allocated Ugandan children aged 1-10 years with uncomplicated falciparum malaria and normal G6PD enzyme function to receive artemether-lumefantrine , combined with either placebo or with 0.1 mg/kg , 0.4 mg/kg , or 0.75 mg/kg ( WHO reference dose ) primaquine base .
METHODS	Randomisation was done with computer-generated four-digit treatment assignment codes allocated to random dose groups in block sizes of 16 .
METHODS	Study staff who provided care or assessed outcomes and the participants remained masked to the intervention group after assignment .
METHODS	The primary efficacy endpoint was the non-inferiority of the mean duration of gametocyte carriage in the test doses compared with the reference group of 0.75 mg primaquine per kg , with a non-inferiority margin of 2.5 days .
METHODS	The primary safety endpoint was the superiority of the arithmetic mean maximum decrease in haemoglobin concentration from enrolment to day 28 of follow-up in the primaquine treatment groups compared with placebo , with use of significance testing of pairwise comparisons with a cutoff of p = 0.05 .
METHODS	The trial is registered with ClinicalTrials.gov , number NCT01365598 .
RESULTS	We randomly allocated 468 participants to receive artemether-lumefantrine combined with placebo ( 119 children ) or with 0.1 mg/kg ( 116 ) , 0.4 mg/kg ( 116 ) , or 0.75 mg/kg ( 117 ) primaquine base .
RESULTS	The mean duration of gametocyte carriage was 6.6 days ( 95 % CI 5.3-7 .8 ) in the 0.75 mg/kg reference group , 6.3 days ( 5.1-7 .5 ) in the 0.4 mg/kg primaquine group ( p = 0.74 ) , 8.0 days ( 6.6-9 .4 ) in the 0.1 mg/kg primaquine group ( p = 0.14 ) , and 12.4 days ( 9.9-15 .0 ) in the placebo group ( p < 0.0001 ) .
RESULTS	No children showed evidence of treatment-related haemolysis , and the mean maximum decrease in haemoglobin concentration was not associated with the dose of primaquine received-it did not differ significantly compared with placebo ( 10.7 g/L , SD 11.1 ) in the 0.1 mg/kg ( 11.4 g/L , 9.4 ; p = 0.61 ) , 0.4 mg/kg ( 11.3 g/L , 10.0 ; p = 0.67 ) , or 0.75 mg/kg ( 12.7 g/L , 8.2 ; p = 0.11 ) primaquine groups .
CONCLUSIONS	We conclude that 0.4 mg/kg primaquine has similar gametocytocidal efficacy to the reference 0.75 mg/kg primaquine dose , but a dose of 0.1 mg/kg was inconclusive for non-inferiority .
CONCLUSIONS	Our findings call for the prioritisation of further trials into the efficacy and safety of doses of primaquine between 0.1 mg/kg and 0.4 mg/kg ( including the dose of 0.25 mg/kg recently recommended by WHO ) , in view of the potential for widespread use of the drug to block malaria transmission .
BACKGROUND	Wellcome Trust and the Bill & Melinda Gates Foundation .

###24299276
BACKGROUND	U.S. poison centers decrease medical visits by providing telephone advice for home management of potential poisonings , but are underutilized by low-income African-American and Latino parents , and those with limited English proficiency , due to lack of knowledge and misconceptions about poison centers .
OBJECTIVE	To assess the effectiveness of a poison prevention video module in improving knowledge , behavior , and behavioral intention concerning use of poison centers in a population of low-income , language-diverse adults attending parenting courses offered by a community organization .
METHODS	A randomized , blinded , controlled trial was conducted at 16 parenting course sites of a community organization and included 297 participants .
METHODS	The organization 's instructors presented the video module ( intervention ) or the usual class curriculum ( control ) .
METHODS	Participants completed questionnaires at baseline and a telephone interview 2-4 weeks later .
METHODS	Changes from baseline to follow-up were compared between the intervention and control groups using analysis of variance and Chi-square tests .
METHODS	Intervention group participants were stratified by English proficiency and compared to assess baseline and follow-up responses by language .
RESULTS	After the intervention , participants in the intervention group had a significantly greater increase in knowledge about the poison center , were more likely to have the correct poison center phone number at home , and had greater behavioral intention to use the poison center compared to control group participants .
RESULTS	At baseline , Spanish-primary-language participants with limited English proficiency had less knowledge about the poison center , were less likely to have the poison center number at home , and had lower behavioral intention to use the poison center than English proficient participants , but significantly improved after the intervention .
CONCLUSIONS	This video module , when presented by a community organization 's instructors , was highly effective in improving knowledge , behavior , and behavioral intention concerning use of poison centers within a low-income , language-diverse population .

###25701070
OBJECTIVE	To evaluate the potential benefit of systematic preoperative coronary-artery angiography followed by selective coronary-artery revascularization on the incidence of myocardial infarction ( MI ) in patients undergoing carotid endarterectomy ( CEA ) without a previous history of coronary artery disease ( CAD ) .
METHODS	We randomised 426 patients who were candidates for CEA , with no history of CAD , a normal electrocardiogram ( ECG ) , and a normal cardiac ultrasound .
METHODS	In group A ( n = 216 ) all patients underwent coronary angiography before CEA .
METHODS	In group B ( n = 210 ) CEA was performed without coronary angiography .
METHODS	Patients were not blinded for relevant assessments during follow-up .
METHODS	Primary end-point was the occurrence of MI at 3.5 years .
METHODS	The secondary end-point was the overall survival rate .
METHODS	Median length of follow-up was 6.2 years .
RESULTS	In group A , coronary angiography revealed significant coronary artery stenosis in 68 patients ( 31.5 % ) .
RESULTS	Among them , 66 underwent percutaneous Intervention ( PCI ) prior to CEA and 2 received combined CEA and coronary-artery bypass grafting ( CABG ) .
RESULTS	Postoperatively , no MI was observed in group A , whereas 6 MI occurred in group B , one of which was fatal ( p = .01 ) .
RESULTS	During the study period , 3 MI occurred in group A ( 1.4 % ) and 33 were observed in group B ( 15.7 % ) , 6 of which were fatal .
RESULTS	The Cox model demonstrated a reduced risk of MI for patients in group A receiving coronary angiography ( HR , .078 ; 95 % CI , 0.024-0 .256 ; p < .001 ) .
RESULTS	In addition , patients with diabetes and patients < 70 years presented with an increased risk of MI .
RESULTS	Survival analysis at 6 years by Kaplan-Meier estimates was 95.63.2 % in Group A and 89.73.7 % in group B ( Log Rank = 6.54 , p = .01 ) .
CONCLUSIONS	In asymptomatic coronary-artery patients , systematic coronary angiography prior to CEA followed by selective PCI or CABG significantly reduces the incidence of late MI and increases long-term survival .
CONCLUSIONS	( ClinicalTrials.gov number , NCT02260453 ) .

###24561644
BACKGROUND	Animal and in vitro studies suggest that volatile anaesthetics affect left atrial ( LA ) performance .
BACKGROUND	We hypothesized that human LA pump function and dimensions are altered by volatile anaesthetics in vivo .
METHODS	We performed transthoracic echocardiographic ( TTE ) measurements in 59 healthy subjects ( aged 18-48 yr ) undergoing minor surgery under general anaesthesia .
METHODS	The unpremedicated patients were randomly assigned to anaesthesia with sevoflurane , desflurane , or isoflurane .
METHODS	TTE examinations were performed at baseline and after induction of anaesthesia and upon placement of a laryngeal mask during spontaneous breathing .
METHODS	After changing to intermittent positive pressure ventilation ( IPPV ) , an additional TTE was performed .
METHODS	The study focused on the velocity-time integral of late peak transmitral inflow velocity ( AVTI ) and maximum LA volume .
RESULTS	We found no evidence for relevant differences in the effects of the three volatile anaesthetics .
RESULTS	AVTI decreased significantly from 4.1 ( 1.2 ) cm at baseline to 3.2 ( 1.1 ) cm during spontaneous breathing of 1 minimum alveolar concentration of volatile anaesthetics .
RESULTS	AVTI decreased further to 2.8 ( 1.0 ) cm after changing to IPPV .
RESULTS	The maximum LA volume was 45.4 ( 18.6 ) cm ( 3 ) at baseline and remained unchanged during spontaneous breathing but decreased to 34.5 ( 16.7 ) cm ( 3 ) during IPPV .
RESULTS	Other parameters of LA pump function and dimensions decreased similarly .
CONCLUSIONS	Volatile anaesthetics reduced active LA pump function in humans in vivo .
CONCLUSIONS	Addition of IPPV decreased LA dimensions and further reduced LA pump function .
CONCLUSIONS	Effects in vivo were less pronounced than previously found in in vitro and animal studies .
CONCLUSIONS	Further studies are warranted to evaluate the clinical implications of these findings .
BACKGROUND	NCT0024451 .

###25980150
OBJECTIVE	To investigate the clinical effect of nasal packing of pulmicort respules combined withnasopore after endoscopic sinus surgery .
METHODS	A total of 30 CRSwNP and CRSsNP patients with bilateral functional endoscopic sinus surgery and finished following up visit were randomly choosed , conventionally select the left nasal cavity as the experimental group , the right nasal cavity as the control group .
METHODS	Experimental group to pack the nasal cavity with pulmicort respules union nasopore after surgery and control group to pack the nasal cavity with only nasopore after surgery .
METHODS	The differences were observed in patients with subjective symptoms and recovery of mucosa of operative cavity between the two groups after two weeks , one month and three months .
RESULTS	( 1 ) The postoperative VAS symptoms score about nasal obstruction , nasal secretion , headache , dizziness and distending pain after two weeks , one month and three months in the experiment group were significantly better than those in the control group ( P < 0.05 ) .
RESULTS	( 2 ) The postoperative Lund-Kennedy endoscopic mucosa morphology score after two weeks , one month and three months in the experiment group were significantly better than those in the control group ( P < 0.05 ) ; ( 3 ) After three months , the experiment group had 28 cases with clinic symptoms cured ( 93.3 % ) , Total effective rate was 96.6 % ; The control group had 22 cases with clinic symptoms cured ( 73.3 % ) , total effective rate was 93.3 % .
RESULTS	The cure rate of the experiment group was significantly higher than the control group ( P < 0.05 ) , but there was no statistic difference between the two groups in the total effective rate ( P > 0.05 ) .
CONCLUSIONS	The application of nasal packing of pulmicort respules combined with nasopore after functional endoscopic sinus surgery can effectively relieve postoperative uncomfortable symptoms , promote recovery of mucosa of perative cavity , which deserves clinical promotion .

###24797871
OBJECTIVE	Physician recommendation is a strong predictor of colorectal cancer ( CRC ) screening adherence , but there are no sufficient data specific to primary colonoscopy screening programs .
OBJECTIVE	The primary objective was to compare the effect of primary care physician 's ( PCP ) counseling with information leaflet about CRC screening on participation rate in opportunistic primary colonoscopy screening program .
OBJECTIVE	Secondary objective was to determine the impact of this counseling on a decision to choose unsedated colonoscopy .
METHODS	Six hundred consecutive subjects 50-65 years of age visiting PCP group practice for routine medical consultation were randomly assigned in a 1:1 ratio either to discuss CRC screening with PCP or to receive an information leaflet on CRC screening only .
METHODS	The outcome measures were the participation rate and the proportion of unsedated colonoscopies assessed on subjects ' self-reports collected six months after the intervention .
METHODS	Multivariate logistic regression model with backward selection was used to investigate the association between independent covariates and binary endpoints .
RESULTS	Participation rate was 47.0 % ( 141 subjects ) in the counseling group and 13.7 % ( 41 patients ) in the information leaflet group .
RESULTS	The rates of unsedated colonoscopies were 77.0 % and 39.0 % , respectively .
RESULTS	In a multivariate analyses , PCP 's counseling was associated with higher participation in CRC screening ( adjusted odds ratio [ OR ] 5.33 , 95 % confidence intervals [ 95 % CI ] 3.55-8 .00 ) and higher rate of unsedated colonoscopies ( OR 7.75 , 95 % CI 2.94-20 .45 ) .
CONCLUSIONS	In opportunistic primary colonoscopy screening , PCP 's counseling significantly increases participation rate and decreases demand for sedation compared to recruitment with information materials only .
CONCLUSIONS	NCT01688817 .

###24976311
OBJECTIVE	To compare the impact of low-grade haemorrhage on neurocognitive function in 16-year-old adolescents born preterm , by grade of intraventricular haemorrhage , and term controls .
METHODS	We evaluated 338 preterm adolescents ( birth weight 600-1250g ) for intelligence , executive function and memory tasks .
METHODS	Eleven had grade 3-4 haemorrhage , 44 had grade 2 , 31 had grade 1 , and 251 had no haemorrhage .
METHODS	Group comparisons were made with 102 term age-matched controls , and regression models used to identify the risk that low-grade haemorrhage posed for cognitive , executive function and memory deficits .
RESULTS	Preterm adolescents with grade 2 haemorrhage had higher deficit rates of verbal intelligence , receptive vocabulary , phonemic fluency , cognitive flexibility and phonological fluency than preterm adolescents with grade 1 or no haemorrhage , compared with term controls .
RESULTS	After excluding preterm adolescents with both grade 2 haemorrhage and cystic periventricular leukomalacia , those with isolated grade 2 haemorrhage remained at greater risk of cognitive and executive function deficits than term controls and of cognitive deficits than preterm adolescents with no haemorrhage .
CONCLUSIONS	Our findings suggest that preterm adolescents born in the early 1990s with isolated grade 2 haemorrhage are at increased risk of learning challenges , including cognitive and executive function deficits .

###24970377
BACKGROUND	A Mediterranean diet , with and without small daily amounts of red wine , and physical activity reduce the risk of cerebrovascular disease and improve cognition .
BACKGROUND	An increase in cerebral blood flow may be the underlying mechanism .
BACKGROUND	Under normal conditions , cerebral blood flow velocity changes in the internal carotid arteries and in large basal cerebral arteries correlate closely with cerebral blood flow changes , as the diameter of these vessels hardly changes and only the smaller vessels downstream change their diameter .
METHODS	A prospective randomized controlled trial was performed in 108 patients with carotid atherosclerosis ( mean age 64 years , 67 % men , 66 % on statin therapy ) .
METHODS	Half of them were advised to follow a polyphenol-rich modified Mediterranean diet including 1-2 tomatoes , 3-5 walnuts and a bar of dark chocolate ( 25 g ) a day and to perform moderate physical exercise for 30 min/day ( lifestyle changes ) .
METHODS	Within these two groups , half of the patients were randomized either to avoid any alcohol or to drink 100 ml of red wine ( women ) or 200 ml of red wine ( men ) daily .
METHODS	Bilateral middle cerebral and internal carotid blood flow velocity ( peak systolic , peak end-diastolic and mean ) was measured at baseline and after 4 and 20 weeks using colour-coded duplex ultrasound .
METHODS	Insonation depth and insonation angle were used to identically place the sample volume during follow-up investigations .
METHODS	A general linear model with Tukey-Kramer adjustment for multiple comparisons was used to assess the primary end points .
METHODS	For the analysis we used the mean values of the right and left artery .
RESULTS	Neither lifestyle changes nor red wine had an effect on peak systolic , peak end-diastolic or mean cerebral blood flow velocity .
CONCLUSIONS	Advice on lifestyle changes , including a modified polyphenol-rich Mediterranean diet , a glass of red wine daily and physical exercise , did not affect middle cerebral and internal carotid blood flow velocity in our patient group with carotid atherosclerosis .
CONCLUSIONS	An increase in cerebral blood flow is thus unlikely to be the cause of the reduced risk of cerebrovascular disease and improved cognitive functioning described in the literature .
CONCLUSIONS	One possible explanation for the fact that blood flow velocity was not affected by red wine , diet and physical activity advice is that two thirds of our patients were already on statin therapy .
CONCLUSIONS	Statins increase cerebral blood flow and vasomotor reactivity via nitric oxide .

###24916063
OBJECTIVE	To compare the ability to successfully intubate extremely preterm baboons using conventional direct laryngoscopy ( DL ) vs videolaryngoscopy .
METHODS	A prospective randomized crossover study using experienced and inexperienced neonatal intubators .
METHODS	All participants were shown an educational video on intubation with each device , followed by attempt of the procedure .
METHODS	The time for successful intubation was the primary outcome .
RESULTS	Seven subjects comprised the experienced group , while 10 individuals were in the inexperienced group .
RESULTS	The overall intubation success rate was comparable between both devices ( 53 % vs 26 % , P = 0.09 ) ; however , mean time to intubate with the conventional laryngoscope was faster ( 25.5 vs 39.4 s , P = 0.02 ) .
RESULTS	Although both groups intubated faster with DL , it only reached statistical significance in the inexperienced group ( 27.0 vs 48.7 s , P < 0.05 ) .
CONCLUSIONS	Conventional DL and videolaryngoscopy are suitable modes for intubating extremely preterm baboons .
CONCLUSIONS	Although experienced intubators prefer DL , intubation success rate and time to intubate with both devices were comparable .
CONCLUSIONS	In inexperienced intubators , participants preferred and intubated faster with DL .

###25463375
BACKGROUND	Transluminal renal sympathetic denervation ( RDN ) has been shown to reduce blood pressure ( BP ) in patients with treatment-resistant hypertension .
METHODS	We assessed the effect of multi-electrode RDN on short-term BP variability indexes in resistant hypertensives .
METHODS	Thirty-one patients with drug-resistant uncontrolled hypertension , participants in the EnligHTN I study , underwent ambulatory BP measurements at baseline and 6months after RDN using the EnligHTN ablation catheter ( St. Jude Medical ) .
METHODS	Twelve resistant hypertensives matched for office BP served as control group .
RESULTS	At 6months post-RDN , office BP and 24-hour BP were reduced by 25.6 / 10.3 mmHg and by 10.2 / 6mmHg ( p < 0.001 for all cases ) , respectively .
RESULTS	No significant changes were observed 6months post-RDN in standard short-term BP variability indexes including 24-hour systolic and diastolic average real variability .
RESULTS	The rates of systolic and diastolic 24-hour BP variation were decreased 6months after RDN , ( from 0.40 / 0.30 to 0.34 / 0.24 , p = 0.030 / 0.006 , respectively ) , especially in the responders group ( n = 23 , 74.2 % ) .
RESULTS	No significant differences in BP and BP variability parameters in the control group were detected .
RESULTS	ROC analysis revealed an area under the curve for prediction of response to RDN by systolic time rate of 66.8 % ( 95 % CI : 46.7 % to 87 % ; p = 0.16 ) and by diastolic time rate of 76.1 % ( 95 % CI : 58.2 % to 93.9 % ; p = 0.030 ) .
CONCLUSIONS	Although standard BP variability indexes remained unchanged , the rate of systolic and diastolic BP variation was significantly decreased 6months after RDN in patients with drug-resistant hypertension .
CONCLUSIONS	These novel indexes might also be useful as predictors of response .

###24557411
BACKGROUND	It is a general belief among hip surgeons that minimally invasive surgical ( MIS ) approach for implantation of a total hip arthroplasty ( THA ) allows an improved and faster postoperative rehabilitation because of reduced muscle and soft-tissue damage , less postoperative pain and blood loss , and shorter hospital stay compared with conventional approaches .
BACKGROUND	In the published relative literature though , there are controversial reports and debates on this matter .
BACKGROUND	To our knowledge , there is no study on the medium-term functional results comparing MIS and traditional approaches for total hip replacement .
BACKGROUND	The purpose of this prospective comparative controlled study was to compare MIS with conventional approach , on terms of pain , blood loss , and functional recovery over a follow-up period of 4 years .
METHODS	In a total of 90 consecutive randomly selected adult patients , who suffered from unilateral primary hip osteoarthritis , a cementless Zweymller-Plus THA ( SL-Plus stem , Bicon screw socket ) was implanted by a single senior orthopedic hip surgeon in one institution in the same period .
METHODS	Forty-five patients ( group A ) were operated using an MIS anterolateral , short incision , muscle-sparing approach and 45 ( group B ) with a conventional ( anterolateral modified Watson-Jones ) approach under partial detachment of gluteus medius and minimus .
METHODS	Anthropometric data , blood loss , short-form 36 questionnaire , visual analog scale pain score , and walking endurance were included in the analysis .
METHODS	Approach-related surgical complications ( trochanter major fracture , Bicon malposition ) were recorded .
METHODS	Data were collected postoperatively and at 4-year follow-up .
RESULTS	Two patients of group A and eight patients of group B were excluded from the final analysis .
RESULTS	Thus , 80 patients were eligible for the final evaluation 4 years postoperatively .
RESULTS	Postoperative pain score was less in the MIS group .
RESULTS	However , no differences in perioperative blood loss , functional outcome , and walking endurance were shown between groups .
RESULTS	No difference in Bicon cup implantation angle was measured in postoperative roentgenograms between group A and B patients , no intraoperative trochanter fracture occurred in any patient of both groups .
CONCLUSIONS	The present prospective randomized study revealed no significant mid-term clinical and functional benefit for patients who underwent a THA through an MIS in comparison with those who were managed with a conventional open approach .

###25204467
BACKGROUND	Paper questionnaires are a common means to collect self-reported information in population-based epidemiological studies .
BACKGROUND	Over the past decades , the response rates to epidemiological studies have been decreasing which can affect the selection process of eligible subjects and lead to non-response bias .
BACKGROUND	Hence , research into strategies to increase questionnaire response rates is crucial .
BACKGROUND	The aim of this study was therefore to explore the effectiveness of single-sided questionnaires and an internet option for response in increasing response rates to a population-based study .
METHODS	A 2 2 factorial experiment was embedded within a large population-based study of pain and pain management .
METHODS	Persons in the study sample were 4600 residents in Grampian ( north of Scotland ) aged 25 years and over who were randomly selected from health board records .
METHODS	Sampled persons were randomly assigned to either receive a single-sided or double-sided questionnaire with or without an internet option to respond .
METHODS	The study questionnaire was distributed via post .
RESULTS	The overall study response rate was 36.3 % .
RESULTS	When compared to the reference group that received no intervention ( response rate = 35.5 % ) , the response rate changed only marginally when single-sided questionnaires were distributed ( 35.8 % ) or when an option to reply via the internet was provided ( 34.3 % ) .
RESULTS	A somewhat higher increase in response rates was achieved when both strategies were employed ( 39.6 % ) .
RESULTS	Overall , no significant effect on response rate was determined for each strategy or their interaction .
CONCLUSIONS	Evidence from this study suggests that neither single-sided questionnaires nor the option to reply via the internet resulted in a significant increase in response rates to population-based studies .

###25533872
OBJECTIVE	In an attempt to shed light on management of chronic pain conditions , there has long been a desire to complement behavioral measures of pain perception with measures of underlying brain mechanisms .
OBJECTIVE	Using functional magnetic resonance imaging ( fMRI ) , we undertook this study to investigate changes in brain activity following the administration of naproxen or placebo in patients with pain related to osteoarthritis ( OA ) of the carpometacarpal ( CMC ) joint .
METHODS	A placebo-controlled , double-blind , 2-period crossover study was performed in 19 individuals with painful OA of the CMC joint of the right hand .
METHODS	Following placebo or naproxen treatment periods , a functionally relevant task was performed , and behavioral measures of the pain experience were collected in identical fMRI examinations .
METHODS	Voxelwise and a priori region of interest analyses were performed to detect between-period differences in brain activity .
RESULTS	Significant reductions in brain activity following treatment with naproxen , compared to placebo , were observed in brain regions commonly associated with pain perception , including the bilateral primary somatosensory cortex , thalamus , and amygdala .
RESULTS	Significant relationships between changes in perceived pain intensity and changes in brain activity were also observed in brain regions previously associated with pain intensity .
CONCLUSIONS	This study demonstrates the sensitivity of fMRI to detect the mechanisms underlying treatments of known efficacy .
CONCLUSIONS	The data illustrate the enticing potential of fMRI as an adjunct to self-report for detecting early signals of efficacy of novel therapies , both pharmacologic and nonpharmacologic , in small numbers of individuals with persistent pain .

###25425015
OBJECTIVE	Lercanidipine hydrochloride and felodipine sustained-release tablets comparison for the treatment of patients with mild-to-moderate primary hypertension .
METHODS	The study was designed as a multicenter , randomized , open-label , parallel-group clinical trial .
METHODS	A total of 281 adult patients ( 18-75 years ) with a mild-to-moderate primary hypertension diagnosis were randomly assigned , in a 1:1 ratio , to lercanidipine hydrochloride ( n = 139 ; 81 males ) or felodipine sustained-release tablets ( n = 142 ; 87 males ) .
METHODS	Study duration was 8 weeks , including two run-in weeks and 6 weeks of treatment .
METHODS	The mean seated diastolic blood pressure ( BP ) change from baseline to 6 weeks of treatment was the primary endpoint .
METHODS	Main secondary efficacy parameters were : ( i ) mean seated systolic BP change from baseline to 6 weeks of treatment ; ( ii ) normalization BP rate .
METHODS	The incidence of adverse events was also considered .
RESULTS	BP monitoring showed a significant decrease compared with baseline in diastolic BP ( lercanidipine : from 964 to 836mmHg , p < 0.0001 ; felodipine : from 964 to 825mmHg , p < 0.0001 ) .
RESULTS	The mean systolic BP decreased , when compared with baseline values , by 18mmHg and 19mmHg in the lercanidipine and felodipine arm , respectively ( p < 0.0001 versus baseline for both comparisons ) .
RESULTS	The normalization rates of BP were 79.5 % and 87.2 % , in the lercanidipine and felodipine groups , respectively ( in-office monitoring ; p = n.s. ) .
RESULTS	In total , 73 patients experienced 103 AEs : 26.6 % ( 37/139 ) in the lercanidipine group and 25.3 % ( 36/142 ) in the felodipine arm ( p = n.s. ) .
RESULTS	The analysis of safety showed no unexpected adverse events .
CONCLUSIONS	Although the overall short follow-up of the present study should be taken into account , lercanidipine is an effective and safe treatment option for BP control in adult patients with mild-to-moderate primary hypertension .

###24320900
BACKGROUND	There is evidence of a possible relationship between Archaea and periodontal disease ; however , to date few studies have assessed the changes in prevalence of this domain after periodontal therapy .
BACKGROUND	The aim of this randomized double-blind and placebo-controlled study was to assess if periodontal treatment with or without systemic antibiotic would change the prevalence of Archaea after periodontal therapy .
METHODS	Thirty subjects were randomly assigned to receive scaling and root planing ( SRP ) alone or combined with metronidazole ( MTZ ) + amoxicillin ( AMX ) for 14days .
METHODS	Clinical and microbiological examinations were performed at baseline and at six months post-SRP .
METHODS	Nine subgingival plaque samples per subject were analysed for the presence of Archaea .
RESULTS	SRP alone or combined with MTZ + AMX significantly reduced the prevalence of subjects colonized by Archaea at six months post-therapy .
RESULTS	However , no significant differences between treatment groups were observed ( p > 0.05 ) .
RESULTS	Both therapies led to a statistically significant decrease in the mean percentage of sites colonized by Archaea ( p < 0.05 ) .
RESULTS	A negative Spearman correlation was observed between the presence of Archaea and the mean clinical attachment gain at six months post-therapy ( r ( 2 ) = -0.61 ; 95 % CI -0.80 - -0.31 ; p = 0.003 ) .
CONCLUSIONS	SRP alone or combined with MTZ + AMX provides a similar reduction in the prevalence of Archaea in the subgingival biofilm of subjects with generalized aggressive periodontitis .

###25805493
OBJECTIVE	To evaluate Medical Reserve Corps volunteers and public health workers in conducting chronic care triage by use of a rubric prior to sheltering to connect survivors with services .
METHODS	Participants were randomly assigned to 1 of 3 algorithms or a control group during a simulated disaster scenario and were asked to rate 20 survivors arriving at a chronic care triage station with situation-appropriate transport services .
METHODS	Survivors were simulated on the basis of the expected disability distributions of mobility , sensory-visual , cognition , medical devices , capacity to perform activities of daily living ( ADLs ) , age ( 18 to 90 years ) , weight , and gender expected in the general population but expanded to 90 % of those presenting .
METHODS	Mean percentage correct scores were assessed by using one-way analysis of variance .
RESULTS	Accounting for personal care assistance and service methodology during chronic care triage increased efficiency by up to 8 % in meeting chronic care health service needs during disaster community mass care management .
CONCLUSIONS	A chronic care triage process as part of community mass care management that considers the availability of personal care assistance and service methodology will enhance the allocation of functional needs support services and increase compliance with Americans with Disabilities Act requirements regarding not segregating persons because of disability .
CONCLUSIONS	( Disaster Med Public Health Preparedness .
CONCLUSIONS	2015 ; 9:265 -274 ) .

###26262795
OBJECTIVE	Testosterone use in older men is increasing , but its long-term effects on progression of atherosclerosis are unknown .
OBJECTIVE	To determine the effect of testosterone administration on subclinical atherosclerosis progression in older men with low or low-normal testosterone levels .
METHODS	Testosterone 's Effects on Atherosclerosis Progression in Aging Men ( TEAAM ) was a placebo-controlled , double-blind , parallel-group randomized trial involving 308 men 60 years or older with low or low-normal testosterone levels ( 100-400 ng/dL ; free testosterone < 50 pg/mL ) , recruited at 3 US centers .
METHODS	Recruitment took place between September 2004 and February 2009 ; the last participant completed the study in May 2012 .
METHODS	One hundred fifty-six participants were randomized to receive 7.5 g of 1 % testosterone and 152 were randomized to receive placebo gel packets daily for 3 years .
METHODS	The dose was adjusted to achieve testosterone levels between 500 and 900 ng/dL .
METHODS	Coprimary outcomes included common carotid artery intima-media thickness and coronary artery calcium ; secondary outcomes included sexual function and health-related quality of life .
RESULTS	Baseline characteristics were similar between groups : patients were a mean age of 67.6 years ; 42 % had hypertension ; 15 % , diabetes ; 15 % , cardiovascular disease ; and 27 % , obesity .
RESULTS	The rate of change in intima-media thickness was 0.010 mm/year in the placebo group and 0.012 mm/year in the testosterone group ( mean difference adjusted for age and trial site , 0.0002 mm/year ; 95 % CI , -0.003 to 0.003 , P = .89 ) .
RESULTS	The rate of change in the coronary artery calcium score was 41.4 Agatston units/year in the placebo group and 31.4 Agatston units/year in the testosterone group ( adjusted mean difference , -10.8 Agatston units/year ; 95 % CI , -45.7 to 24.2 ; P = .54 ) .
RESULTS	Changes in intima-media thickness or calcium scores were not associated with change in testosterone levels among individuals assigned to receive testosterone .
RESULTS	Sexual desire , erectile function , overall sexual function scores , partner intimacy , and health-related quality of life did not differ significantly between groups .
RESULTS	Hematocrit and prostate-specific antigen levels increased more in testosterone group .
CONCLUSIONS	Among older men with low or low-normal testosterone levels , testosterone administration for 3 years vs placebo did not result in a significant difference in the rates of change in either common carotid artery intima-media thickness or coronary artery calcium nor did it improve overall sexual function or health-related quality of life .
CONCLUSIONS	Because this trial was only powered to evaluate atherosclerosis progression , these findings should not be interpreted as establishing cardiovascular safety of testosterone use in older men .
BACKGROUND	clinicaltrials.gov Identifier : NCT00287586 .

###24737258
OBJECTIVE	Ulinastatin , a serine protease inhibitor , inhibits several pro-inflammatory proteases and decreases inflammatory cytokine levels and mortality in experimental sepsis .
OBJECTIVE	We studied the effect of ulinastatin on 28-day all-cause mortality in a double-blind trial in patients with severe sepsis in seven Indian hospitals .
METHODS	Patients with sepsis were randomized within 48 h of onset of one or more organ failures to receive intravenous administration of ulinastatin ( 200,000 IU ) or placebo 12 hourly for 5 days .
RESULTS	Of 122 randomized subjects , 114 completed the study ( 55 receiving ulinastatin , 59 receiving placebo ) .
RESULTS	At baseline , the mean APACHE II score was 13.4 ( SD = 4.4 ) , 48 ( 42 % ) patients were receiving mechanical ventilation , 58 ( 51 % ) were on vasopressors , and 35 % had multiple organ failure .
RESULTS	In the modified intention-to-treat analysis ( patients receiving six or more doses of study drugs ) , 28-day all-cause mortality was 7.3 % with ulinastatin ( 4 deaths ) versus 20.3 % ( 12 deaths ) with placebo ( p = 0.045 ) .
RESULTS	On multivariate analysis too , treatment with ulinastatin ( odds ratio 0.26 , 95 % CI 0.07-0 .95 ; p = 0.042 ) independently decreased 28-day all-cause mortality .
RESULTS	However , the mortality difference did not reach statistical significance in the intention-to-treat analysis [ 10.2 % ( 6/59 deaths ) with ulinastatin versus 20.6 % ( 13/63 deaths ) in the placebo group ; p = 0.11 ] .
RESULTS	The ulinastatin group had lower incidence of new-onset organ failure ( 10 vs. 26 patients , p = 0.003 ) , more ventilator-free days ( mean SD 19.4 10.6 days vs. 10.2 12.5 days , p = 0.019 ) , and shorter hospital stay ( 11.8 7.1 days vs. 24.2 7.2 days , p < 0.001 ) .
CONCLUSIONS	In this pilot study , intravenous administration of ulinastatin reduced mortality in patients with severe sepsis in the modified intention-to-treat analysis , but not in the intention-to-treat analysis .

###25462201
OBJECTIVE	Although robotic surgery decreases pain compared to laparotomy , postoperative pain can be a concern near the site of a larger assistant trocar site .
OBJECTIVE	The aim of this study was to determine the efficacy of transversus abdominis plane ( TAP ) block on 24-hour postoperative opiate use after robotic surgery for gynecologic cancer .
METHODS	Sixty-four subjects with gynecologic malignancies who were scheduled to undergo robotic surgery were enrolled into the study .
METHODS	They were randomized to receive a unilateral TAP block to the side of the assistant port via ultrasound guidance .
METHODS	The block was comprised of 30 cc of 0.25 % bupivacaine with 3 mcg/mL epinephrine or saline .
METHODS	Opiate use was measured and converted into IV morphine equivalents .
METHODS	Patient-reported pain was measured using the Brief Pain Inventory ( BPI ) and Visual Analog Scale ( VAS ) .
RESULTS	The treatment group used a mean of 64.9 mg morphine in the first 24h compared to 69.3 mg for controls ( primary outcome , p = 0.52 ) .
RESULTS	After age-adjustment , the treatment group used a mean of 11.1 mg morphine less than controls ( p = 0.09 ) .
RESULTS	Postoperative pain scores assessed by the BPI ( 6.44 vs. 6.97 , p = 0.37 ) and the VAS ( 3.12 vs. 3.61 , p = 0.30 ) were equivalent .
RESULTS	Block placement was uncomplicated in 98.4 % of participants with mean BMI of 35.3 kg/m ( 2 ) .
RESULTS	Linear regression revealed an approximate 8.1 mg decrease in morphine equivalents used per additional decade of life ( p = 0.0008 ) .
RESULTS	There was a positive correlation between the amount of opiates and BMI with an additional 8.8 mg of morphine per 10 kg/m ( 2 ) increase in BMI ( p = 0.0012 ) .
CONCLUSIONS	TAP block is safe and feasible in this patient population with a large proportion of morbid obesity .
CONCLUSIONS	Preoperative TAP block does not significantly decrease opiate use .
CONCLUSIONS	However ; based on these data , a clinically useful nomogram has been created to aid clinicians in postoperative opiate-dosing for patients based on age and BMI .

###24373475
OBJECTIVE	Air ambulances provide patients with timely access to referral centers .
OBJECTIVE	Nonemergent transfers are planned for efficient aircraft use .
OBJECTIVE	This study compares a novel flight planning optimization application to traditional planning methods .
METHODS	This prospective study compared real-world use of the application to traditional methods in a large air medical system .
METHODS	Each day was randomized to application use or manual methods .
METHODS	Descriptive statistics compared the resulting schedules through ratios of distance flown and cost to minimum distance required .
RESULTS	Manual methods were used on 33 days to plan 479 requests , yielding 181 flights , 856 flying hours , and 289,627 km flown .
RESULTS	Ratios of distance flown and cost were 1.47 km flown and $ 4.98 per km required .
RESULTS	The application was used on 25 days to plan 360 requests , yielding 146 flights , 639 flying hours , and 216,944 km flown .
RESULTS	The corresponding ratios were 1.4 km flown and $ 4.65 per km required .
RESULTS	The average distance flown per distance required decreased by 5 % ( P = .07 ) , and the average cost per average required distance decreased by 7 % ( P = .03 ) when using the application .
CONCLUSIONS	Prospective , real-world use of the application results in efficiencies when planning nonurgent patient transfers .
CONCLUSIONS	Additional savings may be possible through further application refinements .

###24757084
OBJECTIVE	The aim of this study was to assess the efficacy and safety of ivabradine ( Iva ) noninferiority to atenolol ( Aten ) in Chinese patients with chronic stable angina pectoris .
METHODS	In this double-blind , double-dummy trial , patients with symptomatic angina pectoris and positive exercise tolerance test were randomized into the Iva [ 5 or 7.5 mg bis in die ( BID ) ] or Aten group ( 12.5 or 25mg BID ) according to computer-generated random numbers for 12weeks .
RESULTS	One hundred and sixty-eight patients were randomized to the Iva group and 166 to the Aten group .
RESULTS	In a full analysis set , increases in the total exercise duration ( TED ) were 54.3120.1 seconds with Iva 5mg and 58.8114.7 seconds with Aten 12.5 mg at the fourth week , and at the 12th week , TED improved by 84.1130.5 seconds with Iva and 77.8126.6 seconds with Aten ( 95 % CI : -21.4 -34.1 seconds , p = 0.0011 for noninferiority ) .
RESULTS	The analysis of per protocol set yielded similar results ( 95 % CI : -31.4 -33.0 seconds , p = 0.0131 for noninferiority ) .
RESULTS	Heart rate was reduced in both groups at rest and during peak exercise .
RESULTS	There were small , nonsignificant differences in the number of adverse events between the two groups ( 66 in Iva and 73 in Aten , p > 0.05 ) .
RESULTS	Nine patients ( 5.42 % ) were reported to develop phosphenes/luminous phenomena and blurred vision in the Iva group ( p = 0.0035 ) .
CONCLUSIONS	Iva is effective in reducing heart rates and improving exercise capacity and noninferior to Aten in Chinese patients with chronic stable angina pectoris .
CONCLUSIONS	Iva is well tolerated and safe .

###24491639
OBJECTIVE	To investigate the effect of topical glucose on visual parameters in individuals with primary open-angle glaucoma ( POAG ) .
METHODS	Double-blind , randomized , crossover study .
METHODS	Nondiabetic pseudophakic patients with definite POAG were recruited ; 29 eyes of 16 individuals participated in study 1 .
METHODS	A follow-up study ( study 2 ) included 14 eyes of 7 individuals .
METHODS	Eyes were randomly allocated to receive 50 % glucose or saline eye drops every 5 minutes for 60 minutes .
METHODS	The contrast sensitivity and best-corrected logarithm of the minimum angle of resolution ( logMAR ) .
RESULTS	The 50 % glucose reached the vitreous in pseudophakic but not phakic individuals .
RESULTS	Glucose significantly improved the mean contrast sensitivity at 12 cycles/degree compared with 0.9 % saline by 0.26 log units ( 95 % confidence interval [ CI ] , 0.13-0 .38 ; P < 0.001 ) and 0.40 log units ( 95 % CI , 0.17-0 .60 ; P < 0.001 ) in the follow-up study .
RESULTS	The intraocular pressure , refraction , and central corneal thickness were not affected by glucose ; age was not a significant predictor of the response .
CONCLUSIONS	Topical glucose temporarily improves psychophysical visual parameters in some individuals with POAG , suggesting that neuronal energy substrate delivery to the vitreous reservoir may recover function of `` sick '' retinal neurons .

###26181703
OBJECTIVE	The CAPRISA 004 trial showed that coitally dosed tenofovir 1 % gel reduced HIV acquisition by 39 % overall and 54 % when used consistently .
OBJECTIVE	The objective of this analysis was to ascertain its pharmacokinetic-pharmacodynamic relationship to protect against HIV acquisition .
METHODS	Genital and systemic tenofovir concentrations in 34 women who acquired HIV ( cases ) were compared with 302 randomly selected women who remained HIV uninfected ( controls ) during the CAPRISA 004 trial .
METHODS	In total , 336 cervicovaginal fluid ( CVF ) , 55 plasma , and 23 paired cervical and vaginal tissue samples were assayed by validated methods for tenofovir and tenofovir diphosphate ( tenofovir-DP ) detection .
RESULTS	Tenofovir was detected in the genital tract in 8 ( 23.5 % ) cases and 119 ( 39.4 % ) controls ( P = 0.076 ) .
RESULTS	Among those with detectable genital tract tenofovir , the median CVF concentrations were 97 % lower in cases compared with controls , 476 versus 13,821 ng/mL ( P = 0.107 ) .
RESULTS	A total of 14.7 % ( 5/34 ) of cases and 32.8 % ( 99/302 ) of controls were found to have tenofovir CVF concentrations above 100 ng/mL [ odds ratio ( OR ) : 0.35 , P = 0.037 ] .
RESULTS	At a higher threshold , 8.8 % ( 3/34 ) of cases and 26.2 % ( 79/302 ) of controls were found to have tenofovir CVF concentrations above 1000 ng/mL ( OR : 0.27 , P = 0.036 ) .
RESULTS	Plasma tenofovir concentrations were < 1 ng/mL in all women and were detected only in controls ( 16.7 % ) and not in cases ( 0 % ) , ( P = 0.031 ) .
RESULTS	Returned used tenofovir gel applicators and CVF concentrations were correlated ( Spearman r = 0.22 , P = 0.001 ) .
CONCLUSIONS	A tenofovir concentration of 100 ng/mL in CVF was associated with 65 % ( 95 % CI : 6 % to 87 % ) protection against HIV , whereas a 1000 ng/mL concentration correlated with 76 % ( 95 % CI : 8 % to 92 % ) protection against HIV infection .

###24564307
OBJECTIVE	To compare effects of 2 acetylcholinesterase inhibitors on recovery quality of horses anesthetized with isoflurane .
METHODS	6 horses in phase 1 , 7 horses in phase 2A , and 14 horses in phase 2B .
METHODS	The study comprised 3 phases ( 2 randomized , blinded crossover phases in horses undergoing orthopedic procedures and 1 prospective dose-determining phase ) .
METHODS	In phase 1 , horses were anesthetized with isoflurane and received neostigmine or saline ( 0.9 % NaCl ) solution prior to anesthetic recovery .
METHODS	Phase 2A was a physostigmine dose-determining phase .
METHODS	In phase 2B , horses were anesthetized with isoflurane and received neostigmine or physostigmine prior to recovery .
METHODS	Objective recovery events were recorded and subjective visual analogue scale scores of recovery quality were assigned from video recordings .
RESULTS	Recovery measures in phase 1 were not different between horses receiving neostigmine or saline solution .
RESULTS	In phase 2A , 0.04 mg of physostigmine/kg was the highest cumulative dose that did not cause clinically relevant adverse behavioral or gastrointestinal effects .
RESULTS	Horses receiving physostigmine had higher mean SD visual analogue scale recovery scores ( 70.8 13.3 mm ) than did horses receiving neostigmine ( 62.4 12.8 mm ) in phase 2B , with fewer attempts until sternal and standing recovery .
RESULTS	Incidence of colic behavior did not differ among groups .
CONCLUSIONS	Inhibition with physostigmine improved anesthetic recovery quality in horses anesthetized with isoflurane , compared with recovery quality for horses receiving neostigmine .
CONCLUSIONS	Inhibition of central muscarinic receptors by inhalation anesthetics may underlie emergence delirium in horses recovering from anesthesia .

###24478047
OBJECTIVE	The purpose of this study is to test the feasibility of conducting a community-based randomized controlled trial evaluating a culturally tailored community-based group diabetes self-management education ( DSME ) program among rural African Americans .
METHODS	Thirty-two African American rural adults with type 2 diabetes were recruited and 25 adults were retained and participated in an interventional study designed to test the effectiveness of the `` Taking Care of Sugar '' DSME program for the 2-year follow-up .
METHODS	Participants were selected from rural central Virginia .
METHODS	Primary outcomes variables included average blood sugar levels , cardiovascular risk factors , and general physical and mental health .
METHODS	These outcomes were assessed at baseline , 3 months , 6 months , and 12 months post baseline .
RESULTS	From baseline to 3-month follow-up assessment , participants exhibited significant improvement on several physiological and behavioral measures .
RESULTS	Given the small sample size , hypothesis testing was limited .
RESULTS	Results show change from baseline over time , illustrating that the primary outcome of A1C decreased , although not significant .
RESULTS	Additionally , participants reported more knowledge about diabetes self-management and personal care skills ( ie , exercise and foot care ) that persisted over time .
RESULTS	The feasibility of the culturally tailored DSME was established , and participation with the program was high .
CONCLUSIONS	A community-based group DSME program using storytelling is feasible .
CONCLUSIONS	This research will help to inform clinicians and health policymakers as to the types of interventions that are feasible in a larger rural population .
CONCLUSIONS	If such a program is carried out , we can improve knowledge , reduce complications , and improve quality of life among rural African Americans .

###24747626
OBJECTIVE	The aim of this study was to evaluate the treatment results of the application of nitric oxide ( NO ) in the form of topical glyceryl trinitrate ( GTN ) for the treatment of lateral epicondylitis ( LE ) .
METHODS	The study included 40 patients with LE randomized into 2 equal groups .
METHODS	Selection criteria included the presence of pain , tenderness , and positive pain stimulating maneuvers .
METHODS	Glyceryl trinitrate patches were applied to the area of maximal tenderness once a day in the treatment group and placebo patches in the control group .
METHODS	Outcomes in terms of pain relief was assessed using the visual analog scale ( VAS ) and were evaluated according to the criteria of Verhaar et al. .
METHODS	Excellent or good results were considered successful .
METHODS	Differences in VAS scores between the two groups were calculated using the Mann-Whitney U-test and the chi-square test was used to investigate distributions of categorical variables ( sex , affected side ) and good and excellent results among groups .
RESULTS	There were no significant differences in any of the baseline clinical parameters between groups .
RESULTS	At the 3rd week follow-up , there were statistically significant differences in the pain measured using VAS between groups ( mean VAS score of the control and treatment groups were 6.45 and 3.15 , respectively ) ( p = 0.001 ) .
RESULTS	Patients in the GTN group and control group had lower VAS pain scores and reduced elbow pain at 3 weeks ( 3.15 vs 8.05 in the GTN and 6.45 vs 8.80 in the control group ) .
RESULTS	In the control group , no patient had excellent or good results while 18 ( 90 % ) patients in treatment group reported successful treatment .
RESULTS	There was statistically significant difference in the VAS measured at 6 months between groups ( mean VAS score of the control and treatment groups were 4.85 and 0.70 , respectively ) ( p = 0.001 ) .
CONCLUSIONS	The administration of NO directly over an area of tendinopathy through a GTN patch reduces pain and other symptoms in chronic LE .

###24831447
BACKGROUND	CD4 count is a proxy for the extent of immune deficiency and declines in CD4 count are a measure of disease progression .
BACKGROUND	Decline in CD4 count is an important component : for estimating benefits of ARV treatment ; for individual level counselling on the rapidity of untreated disease progression and prognosis ; and can be used in planning demand for health services .
BACKGROUND	Our objective is to report CD4 decline and changes in viral load ( VL ) in a group of HIV-infected adults enrolled in a randomized trial of preventive treatment for TB in South Africa where clade C infection predominates .
METHODS	HIV-infected , tuberculin skin test positive adults who were not eligible for antiretroviral ( ARV ) treatment were randomized to a trial of preventive treatment from 2003-2005 .
METHODS	VL and CD4 count were assessed at enrollment and CD4 counts repeated at least annually .
METHODS	During follow-up , individuals whose CD4 counts decreased to < 200 cells/mm ( 3 ) were referred for antiretroviral therapy ( ART ) and were analytically censored .
RESULTS	1106 ARV nave adults were enrolled .
RESULTS	Their median age was 30 years and male to female ratio was 1:5 .
RESULTS	Median baseline CD4 count was 490 cells/mm ( 3 ) ( IQR 351-675 ) .
RESULTS	The overall mean decline in CD4 count was 3.2 cells/mm ( 3 ) per annum [ corrected ] .
RESULTS	Adjusting for age , gender , baseline hemoglobin , smoking and alcohol use had little impact on the estimate of CD4 decline .
RESULTS	However , VL at baseline had a major impact on CD4 decline .
RESULTS	The percent decline in CD4 count was 13.3 % ( 95 % CI 12.0 % , 14.7 % ) , 10.6 % ( 95 % CI 8.8 % , 12.4 % ) , and 13.8 % ( 95 % CI 12.1 % , 15.5 % ) per annum for baseline VLs of < 10,000 ( N = 314 ) , 10,001-100 ,000 ( N = 338 ) , > 100,000 ( N = 122 ) copies/ml .
CONCLUSIONS	Our data suggests that six and a half years will elapse for an individual 's CD4 count to decline from 750 to 350 cells/mm3 in the absence of ART .

###25179788
BACKGROUND	HLA-haploidentical hematopoietic stem cell transplantation ( HSCT ) is suitable for patients lacking related or unrelated HLA-matched donors .
BACKGROUND	Herein , we investigated whether plerixafor ( MZ ) , as an adjunct to G-CSF , facilitated the collection of mega-doses of hematopoietic stem cells ( HSC ) for TCR - / CD19-depleted haploidentical HSCT , and how this agent affects the cellular graft composition .
METHODS	Ninety healthy donors were evaluated .
METHODS	Single-dose MZ was given to 30 ` poor mobilizers ' ( PM ) failing to attain 40 CD34 + HSCs/L after 4 daily G-CSF doses and/or with predicted apheresis yields 12.0 x106 CD34 + cells/kg recipient 's body weight .
RESULTS	MZ significantly increased CD34 + counts in PM .
RESULTS	Nave/memory T and B cells , as well as natural killer ( NK ) cells , myeloid/plasmacytoid dendritic cells ( DCs ) , were unchanged compared with baseline .
RESULTS	MZ did not further promote the G-CSF-induced mobilization of CD16 + monocytes and the down-regulation of IFN - production by T cells .
RESULTS	HSC grafts harvested after G-CSF + MZ were enriched in myeloid and plasmacytoid DCs , but contained low numbers of pro-inflammatory 6-sulfo-LacNAc + ( Slan ) - DCs .
RESULTS	Finally , children transplanted with G-CSF + MZ-mobilized grafts received greater numbers of monocytes , myeloid and plasmacytoid DCs , but lower numbers of NK cells , NK-like T cells and Slan-DCs .
CONCLUSIONS	MZ facilitates the collection of mega-doses of CD34 + HSCs for haploidentical HSCT , while affecting graft composition .

###24782291
OBJECTIVE	To examine the hypothesis that improving insulin sensitivity improves vascular function in rheumatoid arthritis ( RA ) .
METHODS	We performed a 20-week , single center , randomized , double-blind , placebo-controlled crossover study .
METHODS	Patients with RA ( n = 34 ) with moderate disease activity who were receiving stable disease-modifying antirheumatic drug therapy were randomized to drug sequence , receiving either pioglitazone 45 mg/day or matching placebo for 8 weeks , followed by a 4-week washout period and the alternative treatment for 8 weeks .
METHODS	We measured changes in vascular stiffness ( augmentation index and aortic pulse wave velocity [ PWV ] ) , endothelial function ( reactive hyperemia index ) , and blood pressure .
METHODS	High-sensitivity C-reactive protein levels and the homeostatic model assessment of insulin resistance were also measured .
METHODS	The treatment effect of pioglitazone on outcomes was analyzed using linear mixed-effects models .
RESULTS	Pioglitazone treatment resulted in a change in augmentation index of -4.7 % units ( 95 % confidence interval [ 95 % CI ] -7.9 , -1.5 ) ( P = 0.004 ) and in diastolic blood pressure of -3.0 mm Hg ( 95 % CI -5.7 , -0.2 ) ( P = 0.03 ) , but did not significantly change aortic PWV ( P = 0.33 ) or reactive hyperemia index ( P = 0.46 ) .
RESULTS	The improvements in augmentation index and diastolic blood pressure were not mediated by the effect of pioglitazone on insulin resistance or inflammation .
CONCLUSIONS	Our findings indicate that pioglitazone improves some indices of vascular function , including augmentation index and diastolic blood pressure , in patients with RA .
CONCLUSIONS	This is not mediated by improved insulin sensitivity .

###24841321
BACKGROUND	Multiple sclerosis ( MS ) is a chronic autoimmune disease that can deteriorate cognitive function in at least 50 % of patients even in the early stages .
OBJECTIVE	We conducted a three-arm parallel study with balanced randomization to evaluate the effect of various disease-modifying therapies ( DMTs ) on cognitive function in MS.
METHODS	Ninety newly diagnosed , definite MS subjects referred to Ghaem Medical Center , Mashhad , Iran , were enrolled into this study between 2006 and 2009 .
METHODS	They were randomly categorized into three DMT groups ; Avonex , Rebif and Betaferon .
METHODS	Cognition status was assessed in MS patients at baseline and 12 months after treatment with DMTs using the 5 tests of the Brief Repeatable Battery of Neuropsychological Tests ( BRB-N ) .
RESULTS	The Symbol Digit Modalities Test scores improved in all groups at 12 month vs. baseline ( Avonex : 34.50 vs. 38.95 , p = 0.011 ; Rebif : 35.30 vs. 40.13 , p = 0.001 ; Betaferon : 26.18 vs. 29.32 , p = 0.029 ) .
RESULTS	The Selective Reminding Test ( SRT ) - Total , the 10/36-Delay , and the Paced Auditory Serial Addition Test-Easy were improved in Avonex and Rebif but not in Betaferon group .
RESULTS	The SRT-Delay and Word List Generation were improved only in the Avonex group .
RESULTS	There was no significant difference in other components of the BRB-N among these three treatment groups .
CONCLUSIONS	Different types of DMTs may improve some aspects of cognitive function in patients with MS. Treatment with Avonex and Rebif ( Interferon beta-1a preparations ) were more helpful in resolving the cognitive impairments in MS patients compared to Betaferon ( Interferon beta-1b ) as investigated in this study .

###24377221
OBJECTIVE	To compare the efficacy differences of electroacupuncture ( EA ) with intermittent wave , disperse-dense wave and continuous wave combined with rehabilitation therapy for post-stroke shoulder subluxation in order to provide clinical evidence for selection of electroacupuncture wave .
METHODS	Seventy-five cases of shoulder subluxation were randomly divided into an intermittent wave ( IW ) group , a disperse-dense wave ( DW ) group and a continuous wave ( CW ) group , 25 cases in each one .
METHODS	Based on regular treatment including blood pressure and sugar control , EA and rehabilitation therapy were given in three groups .
METHODS	With EA at Jianqian ( Extra ) , Taijian ( Extra ) , Binao ( LI 14 ) , Jianzhong ( Extra ) , Jianzhen ( SI 9 ) , Naoshu ( SI 10 ) , Jianwaishu ( SI 14 ) and Bingfeng ( SI 12 ) , IW group was treated with intermittent wave with a frequency of 15 Hz , DW group was treated with disperse-dense wave with a frequency of 2 Hz/15 Hz and CW group was treated with continuous wave with a frequency of 15 Hz .
METHODS	The EA treatment was given for 20 min , once a day , six times a week and totally for 4 weeks .
METHODS	The Fugl-Meyer score and Barthel index score were used for assessment of function recovery before and after treatment respectively , also the efficacy of three groups was compared .
RESULTS	The total effective rate was 96.0 % ( 24/25 ) in the IW group , which was superior to 68.0 % ( 17 / 25 ) in the DW group and 64.0 % ( 16/25 ) in the CW group ( both P < 0.05 ) .
RESULTS	After the treatment , Fugl-Meyer score and Barthel index score in the three groups were obviously improved ( all P < 0.05 ) , which was most significant in the IW group ( all P < 0.01 ) .
CONCLUSIONS	Electroacupuncture with intermittent wave combined with rehabilitation therapy has superior effect to disperse-dense wave and continuous wave on the treatment of post-stroke shoulder subluxation , which could effectively improve shoulder subluxation and promote shoulder function recovery .

###24679489
OBJECTIVE	This research evaluates the impact of the achievement of an intermediate target glycemic band on the severity of organ failure and mortality .
METHODS	Daily Sequential Organ Failure Assessment ( SOFA ) score and the cumulative time in a 4.0 to 7.0 mmol/L band ( cTIB ) were evaluated daily up to 14 days in 704 participants of the multicentre Glucontrol trial ( 16 centers ) that randomized patients to intensive group A ( blood glucose [ BG ] target : 4.4-6 .1 mmol/L ) or conventional group B ( BG target : 7.8-10 .0 mmol/L ) .
METHODS	Sequential Organ Failure Assessment evolution was measured by percentage of patients with SOFA less than or equal to 5 on each day , percentage of individual organ failures , and percentage of organ failure-free days .
METHODS	Conditional and joint probability analysis of SOFA and cTIB 0.5 or more assessed the impact of achieving 4.0 to 7.0 mmol/L target glycemic range on organ failure .
METHODS	Odds ratios ( OR ) compare the odds risk of death for cTIB 0.5 or more vs cTIB less than 0.5 , where a ratio greater than 1.0 indicates an improvement for achieving cTIB 0.5 or more independent of SOFA or glycemic target .
RESULTS	Groups A and B were matched for demographic and severity of illness data .
RESULTS	Blood glucose differed between groups A and B ( P < .05 ) , as expected .
RESULTS	There was no difference in the percentage of patients with SOFA less than or equal to 5 , individual organ failures , and organ failure-free days between groups A and B over days 1 to 14 .
RESULTS	However , 20 % to 30 % of group A patients failed to achieve cTIB 0.5 or more for all days , and significant crossover confounds interpretation .
RESULTS	Mortality OR was greater than 1.0 for patients with cTIB 0.5 or more in both groups but much higher for group A on all days .
CONCLUSIONS	There was no difference in organ failure in the Glucontrol study based on intention to treat to different glycemic targets .
CONCLUSIONS	Actual outcomes and significant crossover indicate that this result may not be due to the difference in target or treatment .
CONCLUSIONS	Odds ratios-associated achieving an intermediate 4.0 to 7.0 mmol/L range improved outcome .

###25488965
OBJECTIVE	National Comprehensive Cancer Network guidelines recommend patients with head and neck cancer ( HNC ) receive treatment at centers with expertise , but whether provider experience affects survival is unknown .
METHODS	The effect of institutional experience on overall survival ( OS ) in patients with stage III or IV HNC was investigated within a randomized trial of the Radiation Therapy Oncology Group ( RTOG 0129 ) , which compared cisplatin concurrent with standard versus accelerated fractionation radiotherapy .
METHODS	As a surrogate for experience , institutions were classified as historically low - ( HLACs ) or high-accruing centers ( HHACs ) based on accrual to 21 RTOG HNC trials ( 1997 to 2002 ) .
METHODS	The effect of accrual volume on OS was estimated by Cox proportional hazards models .
RESULTS	Median RTOG accrual ( 1997 to 2002 ) at HLACs was four versus 65 patients at HHACs .
RESULTS	Analysis included 471 patients in RTOG 0129 ( 2002 to 2005 ) with known human papillomavirus and smoking status .
RESULTS	Patients at HLACs versus HHACs had better performance status ( 0 : 62 % v 52 % ; P = .04 ) and lower T stage ( T4 : 26.5 % v 35.3 % ; P = .002 ) but were otherwise similar .
RESULTS	Radiotherapy protocol deviations were higher at HLACs versus HHACs ( 18 % v 6 % ; P < .001 ) .
RESULTS	When compared with HHACs , patients at HLACs had worse OS ( 5 years : 51.0 % v 69.1 % ; P = .002 ) .
RESULTS	Treatment at HLACs was associated with increased death risk of 91 % ( hazard ratio [ HR ] , 1.91 ; 95 % CI , 1.37 to 2.65 ) after adjustment for prognostic factors and 72 % ( HR , 1.72 ; 95 % CI , 1.23 to 2.40 ) after radiotherapy compliance adjustment .
CONCLUSIONS	OS is worse for patients with HNC treated at HLACs versus HHACs to cooperative group trials after accounting for radiotherapy protocol deviations .
CONCLUSIONS	Institutional experience substantially influences survival in locally advanced HNC .

###24244325
BACKGROUND	Serial C-reactive protein ( CRP ) values may be useful for decision-making regarding duration of antibiotics in neonates .
BACKGROUND	However , established standard of practice for its use in preterm very low birth weight ( < 1500 g , VLBW ) infants are lacking .
OBJECTIVE	Evaluate compliance with a CRP-guided computerized decision support ( CDS ) algorithm and compare characteristics and outcomes of compliant versus non-compliant cases .
OBJECTIVE	Measure correlation between CRPs and white blood count ( WBC ) indices .
METHODS	We examined 3 populations : 1 ) all preterm VLBW infants born at Vanderbilt 2006-2011 - we assessed provider compliance with CDS algorithm and measured relevant outcomes ; 2 ) all patients with positive blood culture results admitted to the Vanderbilt NICU 2006-2012 - we tested the correlation between CRP and WBC results within 7 days of blood culture phlebotomy ; 3 ) 1,000 randomly selected patients out of the 7,062 patients admitted to the NICU 2006-2012 - we correlated time-associated CRP values and absolute neutrophil counts .
RESULTS	Of 636 VLBW infants in cohort 1 ) , 569 ( 89 % ) received empiric antibiotics for suspected early-onset sepsis .
RESULTS	In 409 infants ( 72 % ) the CDS algorithm was followed ; antibiotics were discontinued 48 hours in 311 ( 55 % ) with normal serial CRPs and continued in 98 ( 17 % ) with positive CRPs , resulting in significant reduction in antibiotic exposure ( p < 0.001 ) without increase in complications or subsequent infections .
RESULTS	One hundred sixty ( 28 % ) were considered non-compliant because antibiotics were continued beyond 48 hours despite negative serial CRPs and blood cultures .
RESULTS	Serial CRPs remained negative in 38 ( 12 % ) of 308 blood culture-positive infants from cohort 2 , but only 4 patients had clinically probable sepsis with single organisms and no immunodeficiency besides extreme prematurity .
RESULTS	Leukopenia of any cell type was not linked with CRPs in cohorts 2 and 3 .
CONCLUSIONS	CDS/CRP-guided antibiotic use is safe and effective in culture-negative VLBW infants .
CONCLUSIONS	CRP results are not affected by low WBC indices .

###26222764
OBJECTIVE	To assess the efficacy of neoadjuvant systemic therapy ( NST ) at increasing the rate of successful breast-conserving therapy ( BCT ) in triple negative breast cancer .
BACKGROUND	Inducing tumor regression to permit BCT is often cited to support administration of NST .
BACKGROUND	To quantify this benefit , we conducted a surgical companion study to CALGB40603 , a randomized phase II , 22 factorial trial of neoadjuvant paclitaxel carboplatin bevacizumab ( B ) followed by doxorubicin plus cyclophosphamide B in stage II-III triple negative breast cancer .
METHODS	Before and after NST , treating surgeons evaluated BCT candidacy by clinico-radiographic criteria ; surgery performed was at surgeon and patient discretion .
METHODS	We measured ( 1 ) conversion rates from BCT-ineligible to BCT-eligible , ( 2 ) surgical choices in BCT candidates , and ( 3 ) rates of successful BCT with tumor-free margins .
RESULTS	Four hundred four patients were assessable for surgical outcomes .
RESULTS	Two hundred nineteen ( 54 % ) were BCT candidates before NST .
RESULTS	One hundred ninety-seven ( 90 % ) remained BCT candidates after NST , of whom 138 ( 70 % ) chose BCT , which was successful in 130 ( 94 % ) .
RESULTS	Of 185 ( 46 % ) who were not BCT candidates before NST , 78 ( 42 % ) converted to candidates with NST .
RESULTS	Of these , 53 ( 68 % ) chose BCT with a 91 % ( 48/53 ) success rate .
RESULTS	The overall BCT-eligibility rate rose from 54 % to 68 % ( 275/404 ) with NST .
RESULTS	Addition of carboplatin , B , or both increased conversion rates .
CONCLUSIONS	This is the first study to document prospectively a 42 % conversion rate from BCT-ineligible to BCT-eligible , resulting in a 14 % absolute increase in BCT eligibility .
CONCLUSIONS	BCT was successful in 93 % of patients who opted for it , but 31 % of BCT-eligible patients still chose mastectomy .

###24942563
OBJECTIVE	To investigate the role of low-intensity extracorporeal shockwave therapy in the treatment of erectile dysfunction .
METHODS	This was a double-blinded , single-center , prospective , randomized , placebo-controlled trial .
METHODS	After a 2-week phosphodiesterase type5 inhibitor washout period , patients were assessed with Sexual Health Inventory for Men , International Index of Erectile Function-ED domain scores and Erection Hardness Score .
METHODS	Randomization into either the low-intensity extracorporeal shockwave therapy group or the sham group took place .
METHODS	After the 9-week treatment period , patients were followed up 4 weeks later .
METHODS	Follow-up assessment was in the form of International Index of Erectile Function-ED domain score and Erection Hardness Score .
RESULTS	A total of 70 patients were recruited into the study , 58 patients completed the study .
RESULTS	A total of 28 patients were randomized into the sham therapy arm , and 30 patients were randomized into the low-intensity extracorporeal shockwave therapy arm .
RESULTS	There was no significant difference between these two groups in baseline International Index of Erectile Function-ED domain score and Erection Hardness Score .
RESULTS	The mean International Index of Erectile Function-ED domain score of the low-intensity extracorporeal shockwave therapy arm and sham arm in week 13 were 17.84.8 and 15.86.1 , respectively ( P = 0.156 ) .
RESULTS	The mean Erection Hardness Scores in week13 were 2.70.5 and 2.40.9 , respectively ( P = 0.163 ) .
RESULTS	When patients were stratified into different baseline Sexual Health Inventory for Men subgroups , the pre-intervention and post-intervention difference in low-intensity extracorporeal shockwave therapy was found to be significant in the subgroup with severe erectile dysfunction ( low-intensity extracorporeal shockwave therapy International Index of Erectile Function-ED domain improvement : 10.14.1 vs sham therapy International Index of Erectile Function-ED domain improvement : 3.23.3 ; P = 0.003 ) .
CONCLUSIONS	The present trial shows the tolerability and clinical efficacy of low-intensity extracorporeal shockwave therapy in a subgroup of patients with erectile dysfunction .

###25733367
OBJECTIVE	Cochlear implantation requires acclimatization to the electrical input .
OBJECTIVE	Usually , cochlear implant ( CI ) listeners undergo an auditory rehabilitation program that includes auditory training sessions .
OBJECTIVE	Recently , it was shown that a phoneme-based training may improve speech perception abilities even in experienced CI listeners .
OBJECTIVE	The current study focuses on whether the effect of an auditory training program depends on the age of CI listeners .
METHODS	Fifteen CI listeners took part in an auditory phoneme-based computer training program .
METHODS	Before and after training , speech recognition tests in moderate and difficult noise ( +5 dB SNR and 0 dB SNR , respectively ) were administered .
METHODS	Additionally , speech recognition was tested 6 months after the training ( follow-up ) .
METHODS	A control group consisting of 12 subjects underwent audiometric testing without any auditory training .
RESULTS	Speech perception in moderate noise improved significantly during the training as revealed by comparing pre - and posttraining scores evaluated in the moderate noise condition .
RESULTS	No significant change was observed for the difficult noise situation at 0 dB SNR .
RESULTS	The speech perception measures of the control group remained unchanged .
RESULTS	No significant effect of age on the training effect was observed .
CONCLUSIONS	Speech recognition can be improved even in experienced CI listeners .
CONCLUSIONS	When motivated to participate , senior CI users with long-term CI experience may benefit in a similar way from an auditory , phoneme-based computer training program as younger CI users .

###24355995
OBJECTIVE	The aim of this study was to directly compare the effects of aerobic training ( AT ) with progressive resistance training ( RT ) after stroke to determine whether AT-induced fitness gains or RT-induced strength gains translate into improved ambulation across a 12-wk intervention and whether gains are retained 1 yr after cessation of formal training .
METHODS	This study is a randomized controlled 12-wk intervention trial with a 1-yr follow-up .
METHODS	Forty-three community-dwelling independent walkers with a chronic ischemic hemiparetic stroke were allocated to AT using a cycle ergometer ( n = 13 ) , RT using training machines ( n = 14 ) , or low-intensity sham training of the arms ( n = 16 ) .
METHODS	The main outcome measures were 6-min walk distance and fast 10-m walking speed .
RESULTS	Comparisons between AT , RT , and sham training revealed no clinically relevant effects on walking velocity or walking distance .
RESULTS	Muscle strength improved after RT ( P < 0.0001 ) and was preserved at 1-yr follow-up ( P < 0.001 ) .
RESULTS	Aerobic capacity increased after AT ( P < 0.001 ) but was lost during the follow-up observation period .
CONCLUSIONS	Improvement of muscle strength or aerobic capacity using non-task-specific training methods does not result in improved ambulation in patients with chronic stroke .
CONCLUSIONS	Muscle strength gains were maintained at follow-up , whereas all improvements of aerobic capacity were lost , indicating a long-lasting effect of intensive RT even without maintenance training .

###25104263
BACKGROUND	New designs of female condom have been developed to reduce costs and improve acceptability .
BACKGROUND	To secure regulatory approvals , clinical studies are needed to verify performance .
BACKGROUND	We aimed to assess the functional performance and safety of three new condom types-the Woman 's Condom , the VA worn-of-women ( wow ) Condom Feminine , and the Cupid female condom-against the existing second-generation female condom ( FC2 ) .
METHODS	We did a randomised controlled , non-inferiority , four-period crossover trial at three sites in Shanghai , China , and one site in Durban , South Africa , between May 1 , 2011 , and Jan 31 , 2012 .
METHODS	Participants aged 18-45 years who were sexually active , monogamous , not pregnant , and not sex workers , were eligible for inclusion if they were literate , had no known allergies to the study products ; used a reliable , non-barrier method of contraception , and had no visible or reported sexually transmitted infections .
METHODS	We used a computer-generated randomisation sequence with a Williams square design of size four to assign patients ( 1:1:1:1 ) to the FC2 control device , or the Woman 's , VA wow , or Cupid condoms , with 12 potential allocations .
METHODS	Randomisation was stratified by site .
METHODS	Participants were not masked to condom type , but allocation was concealed from study investigators .
METHODS	The primary non-inferiority endpoints were total clinical failure and total female condom failure , with a non-inferiority margin of 3 % .
METHODS	Women were asked to use five of each condom type and were interviewed after use of each type .
METHODS	We also assessed safety data for each type .
METHODS	We did both per-protocol and intention-to-treat analyses .
METHODS	We calculated frequencies and percentages for each failure event and estimated differences in performance with a generalised estimating equation model .
METHODS	This study is registered , number DOH-27-0113-4271 .
RESULTS	616 women were assessed for eligibility , of whom 600 were randomly assigned to condom-type order ( 30 , 120 , and 150 women in the three sites in China , and 300 women in the site in South Africa ) .
RESULTS	572 women completed follow-up , with at least one condom of each type .
RESULTS	Total female condom failure was 343 % for FC2 , 385 % for the Woman 's Condom ( difference 042 % , 90 % CI -142 to 226 ) , 302 % for VA wow ( -042 % , -186 to 132 ) , and 452 % for Cupid ( 109 % , -060 to 278 ) ; total clinical failure was 288 % , 305 % ( 017 % , -148 to 181 ) , 249 % ( -025 % , -175 to 126 ) , and 387 % ( 099 % , -055 to 252 ) , respectively .
RESULTS	Only two ( < 1 % ) participants , in South Africa , reported serious adverse events , unrelated to use of the study products .
CONCLUSIONS	Non-inferiority was shown for all condom failure events for the three new devices versus the FC2 , within the predefined margin .
BACKGROUND	Universal Access to Female Condoms ( UAFC ) .

###24862166
OBJECTIVE	To investigate whether vaginal Group B Streptococcus ( GBS ) colonisation or other baseline characteristics of women with preterm premature rupture of membranes ( PPROM ) can help in identifying subgroups of women who would benefit from immediate delivery .
METHODS	Secondary analysis of the PPROMEXIL trials .
METHODS	Sixty hospitals in the Netherlands .
METHODS	Women with PPROM between 34 and 37 weeks of gestation .
METHODS	Random assignment of 723 women to immediate delivery or expectant management .
METHODS	Early onset neonatal sepsis .
RESULTS	Vaginal GBS colonisation status was the only marker which was significantly associated with the benefit of immediate delivery ( P for interaction : 0.04 ) .
RESULTS	GBS colonisation was observed in 14 % of women .
RESULTS	The risk of early onset neonatal sepsis in GBS-positive women was high ( 15.2 % ) when they were managed expectantly but this risk was reduced to 1.8 % with immediate delivery .
RESULTS	The early onset neonatal sepsis risk was much lower in neonates of GBS-negative women : 2.6 % after expectant management and 2.9 % with immediate delivery .
RESULTS	We estimated that by inducing labour only in GBS-positive women , there would be a 10.4 % increase in term delivery rate , while keeping neonatal sepsis and caesarean delivery rates comparable to a strategy of labour induction for all .
CONCLUSIONS	Our post hoc findings suggest that women with PROM between 34 and 37 weeks might benefit from immediate delivery if they have GBS vaginal colonisation , while in GBS-negative women labour induction could be delayed until 37 weeks .

###24613349
BACKGROUND	Depletion of B lymphocytes is associated with suppression of inflammatory activity in multiple sclerosis .
BACKGROUND	We aimed to assess the safety and efficacy of atacicept , a recombinant fusion protein that suppresses B-cell function and antibody production .
METHODS	In this placebo-controlled , double-blind , 36-week , phase 2 trial ( ATAMS ) in Australia , Canada , Europe , and the USA , patients aged 18-60 years with relapsing multiple sclerosis were randomly assigned via an interactive voice response system in a 1:1:1:1 ratio , stratified by geographical region , to receive weekly subcutaneous injections with atacicept ( 25 , 75 , or 150 mg ) or placebo .
METHODS	Both patients and study personnel were masked to treatment assignment .
METHODS	The primary endpoint was the change in mean number of gadolinium-enhancing lesions on T1-weighted MRI per patient per scan between weeks 12 and 36 .
METHODS	Efficacy endpoints were analysed in the intention-to-treat population .
METHODS	Patients who completed week 36 were eligible to participate in a long-term extension study ( ATAMS EXT ) , consisting of a double-blind phase followed by an open-label phase , for a total study time of up to 5 years .
METHODS	The study was terminated early after the independent data and safety monitoring board noted an increased annualised relapse rate with atacicept .
METHODS	The protocol was subsequently amended to include a 60-week safety follow-up , to allow treatment with approved multiple sclerosis drugs , and to change the primary endpoint to gadolinium-enhancing T1 lesions per scan during the entire double-blind period of ATAMS .
METHODS	Both the trial and the extension are registered with ClinicalTrials.gov , numbers NCT00642902 ( ATAMS ) and NCT00853762 ( ATAMS EXT ) .
RESULTS	Between April 23 , 2008 , and early study termination on Sept 11 , 2009 , 255 patients were randomly assigned : 63 to placebo , 63 to atacicept 25 mg , 64 to 75 mg , and 65 to 150 mg .
RESULTS	90 ( 35 % ) patients completed the week 36 treatment visit , 26 ( 10 % ) discontinued before study termination ( including one who dropped out before receiving study treatment ) , and 139 ( 55 % ) discontinued because of study termination .
RESULTS	During the double-blind period of ATAMS , annualised relapse rates were higher in the atacicept groups than in the placebo group ( atacicept 25 mg , 086 , 95 % CI 043-174 ; 75 mg , 079 , 040-158 ; 150 mg , 098 , 052-181 ; placebo , 038 , 017-087 ) .
RESULTS	Mean numbers of gadolinium-enhancing T1 lesions per scan were similar in all groups ( 25 mg , 226 , 097-527 ; 75 mg , 230 , 108-492 ; 150 mg , 249 , 118-527 ; placebo , 307 , 140-677 ) .
RESULTS	Seven patients ( one taking placebo and six atacicept ) discontinued treatment because of adverse events .
RESULTS	One death occurred in the placebo group .
RESULTS	During the safety follow-up , immunoglobulin concentrations and B-cell counts returned towards predose values and annualised relapse rates in the atacicept groups decreased until they were similar to that of the placebo group
CONCLUSIONS	Increased clinical disease activity associated with atacicept suggests that the role of B cells and humoral immunity in multiple sclerosis is complex .
CONCLUSIONS	For studies that explore therapeutic immunomodulation in multiple sclerosis , rigorous monitoring for negative effects on clinical and MRI outcomes is warranted .
BACKGROUND	Merck Serono ( Merck KGaA ) and EMD Serono ( Merck KGaA ) .

###24331204
BACKGROUND	This study evaluated the effectiveness of using trained volunteer staff in reducing 30-day readmissions of congestive heart failure ( CHF ) patients .
METHODS	From June 2010 to December 2010 , 137 patients ( mean age 73 years ) hospitalized for CHF were randomly assigned to either : an interventional arm ( arm A ) receiving dietary and pharmacologic education by a trained volunteer , follow-up telephone calls within 48 hours , and a month of weekly calls ; or a control arm ( arm B ) receiving standard care .
METHODS	Primary outcomes were 30-day readmission rates for CHF and worsening New York Heart Association ( NYHA ) functional classification ; composite and all-cause mortality were secondary outcomes .
RESULTS	Arm A patients had decreased 30-day readmissions ( 7 % vs 19 % ; P < .05 ) with a relative risk reduction ( RRR ) of 63 % and an absolute risk reduction ( ARR ) of 12 % .
RESULTS	The composite outcome of 30-day readmission , worsening NYHA functional class , and death was decreased in the arm A ( 24 % vs 49 % ; P < .05 ; RRR 51 % , ARR 25 % ) .
RESULTS	Standard-care treatment and hypertension , age 65 years and hypertension , and cigarette smoking were predictors of increased risk for readmissions , worsening NYHA functional class , and all-cause mortality , respectively , in the multivariable analysis .
CONCLUSIONS	Utilizing trained volunteer staff to improve patient education and engagement might be an efficient and low-cost intervention to reduce CHF readmissions .

###25234012
OBJECTIVE	To determine the effectiveness of prescribed part-time patching for treatment of intermittent exotropia ( IXT ) in children .
METHODS	Multicenter , randomized clinical trial .
METHODS	Three hundred fifty-eight children 3 to < 11 years of age with previously untreated ( except for refractive correction ) IXT and near stereoacuity of 400 seconds of arc or better were enrolled .
METHODS	Intermittent exotropia met the following criteria : ( 1 ) IXT at distance OR constant exotropia at distance and either IXT or exophoria at near ; ( 2 ) exodeviation ( tropia or phoria ) of at least 15 prism diopters ( PD ) at distance or near by prism and alternate cover test ( PACT ) ; and ( 3 ) exodeviation of at least 10 PD at distance by PACT .
METHODS	Participants were assigned randomly either to observation ( no treatment for 6 months ) or to patching for 3 hours daily for 5 months , with a 1-month washout period of no patching before the 6-month primary outcome examination .
METHODS	The primary outcome was deterioration at either the 3-month or the 6-month follow-up visit , defined as : ( 1 ) constant exotropia measuring at least 10 PD at distance and near by simultaneous prism and cover test , and/or ( 2 ) near stereoacuity decreased by at least 2 octaves from baseline , both assessed by a masked examiner and confirmed by a retest .
METHODS	Participants who were prescribed any nonrandomized treatment without first meeting either deterioration criteria also were counted as having deteriorated .
RESULTS	Of the 324 participants ( 91 % ) completing the 6-month primary outcome examination , deterioration occurred in 10 of the 165 participants ( 6.1 % ) in the observation group ( 3 of these 10 started treatment without meeting deterioration criteria ) and in 1 of the 159 participants ( 0.6 % ) in the part-time patching group ( difference , 5.4 % ; lower limit of 1-sided exact 95 % confidence interval , 2.0 % ; P = 0.004 , 1-sided hypothesis test ) .
CONCLUSIONS	Deterioration of previously untreated childhood IXT over a 6-month period is uncommon with or without patching treatment .
CONCLUSIONS	Although there is a slightly lower deterioration rate with patching , both management approaches are reasonable for treating children 3 to 10 years of age with IXT .

###25596660
BACKGROUND	Panitumumab is a fully human monoclonal antibody that targets EGFR .
BACKGROUND	We aimed to compare chemoradiotherapy plus panitumumab with chemoradiotherapy alone in patients with unresected , locally advanced squamous-cell carcinoma of the head and neck .
METHODS	In this international , open-label , randomised , controlled , phase 2 trial , we recruited patients with locally advanced squamous-cell carcinoma of the head and neck from 41 sites in nine countries worldwide .
METHODS	Patients aged 18 years and older with stage III , IVa , or IVb , previously untreated , measurable ( 10 mm for at least one dimension ) , locally advanced squamous-cell carcinoma of the head and neck ( non-nasopharygeal ) and an Eastern Cooperative Oncology Group performance status of 0-1 were randomly assigned ( 2:3 ) by an independent vendor to open-label chemoradiotherapy ( three cycles of cisplatin 100 mg/m ( 2 ) ) or panitumumab plus chemoradiotherapy ( three cycles of intravenous panitumumab 9.0 mg/kg every 3 weeks plus cisplatin 75 mg/m ( 2 ) ) using stratified randomisation with a block size of five .
METHODS	All patients received 70 Gy to gross tumour and 50 Gy to areas at risk for subclinical disease with standard fractionation .
METHODS	The primary endpoint was local-regional control at 2 years , analysed in all randomised patients who received at least one dose of their assigned protocol-specific treatment ( chemotherapy , radiation , or panitumumab ) .
METHODS	The trial is closed and this is the final analysis .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00500760 .
RESULTS	Between Oct 26 , 2007 , and March 26 , 2009 , 153 patients were enrolled and 150 received treatment ( 63 in the chemoradiotherapy group and 87 in the panitumumab plus chemoradiotherapy group ) .
RESULTS	Local-regional control at 2 years was 68 % ( 95 % CI 54-78 ) in the chemoradiotherapy group and 61 % ( 50-71 ) in the panitumumab plus chemoradiotherapy group .
RESULTS	The most frequent grade 3-4 adverse events were dysphagia ( 17 [ 27 % ] of 63 patients in the chemoradiotherapy group vs 35 [ 40 % ] of 87 in the panitumumab plus chemoradiotherapy group ) , mucosal inflammation ( 15 [ 24 % ] vs 48 [ 55 % ] ) , and radiation skin injury ( eight [ 13 % ] vs 27 [ 31 % ] ) .
RESULTS	Serious adverse events were reported in 20 ( 32 % ) of 63 patients in the chemoradiotherapy group and in 37 ( 43 % ) of 87 patients in the panitumumab plus chemoradiotherapy group .
CONCLUSIONS	In patients with locally advanced squamous-cell carcinoma of the head and neck , the addition of panitumumab to standard fractionation radiotherapy and cisplatin did not confer any benefit , and the role of EGFR inhibition in these patients needs to be reassessed .
BACKGROUND	Amgen .

###25369272
OBJECTIVE	Changes in IL-6 , TNF - , and TNF - receptors - sTNFRI and sTNFRII - were evaluated in a group of professional cyclists treated with immunomodulator AM3 ( Inmunofern ) for 6 months of training and competition .
METHODS	Sixteen male professional cyclists with a similar training program participated in the study which was designed as a randomized , placebo-controlled , double-blind clinical trial .
METHODS	Venous blood samples were collected in basal conditions , before beginning the supplementation program , and after 90 and 180 days of training and competition season .
RESULTS	No significant differences in biochemical parameters or in IL-6 were evidenced between placebo and AM3-treated groups throughout the study .
RESULTS	Plasma TNF - levels significantly decreased ( P < 0.05 ) after 90 days of training in the AM3 treated group .
RESULTS	TNF - receptors increased during training season in both placebo and AM3 treated groups , although the increase was significantly higher ( P < 0.05 ) in the AM3 group with respect to the placebo group .
CONCLUSIONS	The changes produced by regular training and competition were modified throughout the season by AM3 treatment which could reduce the inflammatory response to excessive exercise .

###24350804
BACKGROUND	Text messaging has successfully supported smoking cessation .
BACKGROUND	This study compares a mobile application with text messaging to support smoking cessation .
METHODS	Young adult smokers 18-30 years old ( n = 102 ) participated in a randomized pretest-posttest trial .
METHODS	Smokers received a smartphone application ( REQ-Mobile ) with short messages and interactive tools or a text messaging system ( onQ ) , managed by an expert system .
METHODS	Self-reported usability of REQ-Mobile and quitting behavior ( quit attempts , point-prevalence , 30-day point-prevalence , and continued abstinence ) were assessed in posttests .
RESULTS	Overall , 60 % of smokers used mobile services ( REQ-Mobile , 61 % , mean of 128.5 messages received ; onQ , 59 % , mean of 107.8 messages ) , and 75 % evaluated REQ-Mobile as user-friendly .
RESULTS	A majority of smokers reported being abstinent at posttest ( 6 weeks , 53 % of completers ; 12 weeks , 66 % of completers [ 44 % of all cases ] ) .
RESULTS	Also , 37 % ( 25 % of all cases ) reported 30-day point-prevalence abstinence , and 32 % ( 22 % of all cases ) reported continuous abstinence at 12 weeks .
RESULTS	OnQ produced more abstinence ( p < 0.05 ) than REQ-Mobile .
RESULTS	Use of both services predicted increased 30-day abstinence at 12 weeks ( used , 47 % ; not used , 20 % ; p = 0.03 ) .
CONCLUSIONS	REQ-Mobile was feasible for delivering cessation support but appeared to not move smokers to quit as quickly as text messaging .
CONCLUSIONS	Text messaging may work better because it is simple , well known , and delivered to a primary inbox .
CONCLUSIONS	These advantages may disappear as smokers become more experienced with new handsets .
CONCLUSIONS	Mobile phones may be promising delivery platforms for cessation services using either smartphone applications or text messaging .

###24679395
BACKGROUND	Collaborative care programmes lead to better outcomes in the management of depression .
BACKGROUND	A programme of this nature has demonstrated its effectiveness in primary care in Spain .
BACKGROUND	Our objective was to evaluate the cost-effectiveness of this programme compared to usual care .
METHODS	A bottom-up cost-effectiveness analysis was conducted within a randomized controlled trial ( 2007-2010 ) .
METHODS	The intervention consisted of a collaborative care programme with clinical , educational and organizational procedures .
METHODS	Outcomes were monitored over a 12 months period .
METHODS	Primary outcomes were incremental cost-effectiveness ratios ( ICER ) : mean differences in costs divided by quality-adjusted life years ( QALY ) and mean differences in costs divided by depression-free days ( DFD ) .
METHODS	Analyses were performed from a healthcare system perspective ( considering healthcare costs ) and from a society perspective ( including healthcare costs plus loss of productivity costs ) .
RESULTS	Three hundred and thirty-eight adult patients with major depression were assessed at baseline .
RESULTS	Only patients with complete data were included in the primary analysis ( 166 in the intervention group and 126 in the control group ) .
RESULTS	From a healthcare perspective , the average incremental cost of the programme compared to usual care was 182.53 ( p < 0.001 ) .
RESULTS	Incremental effectiveness was 0.045 QALY ( p = 0.017 ) and 40.09 DFD ( p = 0.011 ) .
RESULTS	ICERs were 4,056 / QALY and 4.55 / DFD .
RESULTS	These estimates and their uncertainty are graphically represented in the cost-effectiveness plane .
CONCLUSIONS	The amount of 13.6 % of patients with incomplete data may have introduced a bias .
CONCLUSIONS	Available data about non-healthcare costs were limited , although they may represent most of the total cost of depression .
CONCLUSIONS	The intervention yields better outcomes than usual care with a modest increase in costs , resulting in favourable ICERs .
CONCLUSIONS	This supports the recommendation for its implementation .

###24621831
OBJECTIVE	To investigate the effects of intravenous administration of dexamethasone on early postoperative cognitive dysfunction ( POCD ) .
METHODS	In this prospective randomized trial , 1000 patients with facial spasm undergoing microvascular decompression ( MVD ) were randomly assigned to receive normal sodium ( Dex-0 group , n = 333 ) , dexamethasone 0.1 mg/kg ( Dex-1 group , n = 333 ) , or dexamethasone 0.2 mg/kg ( Dex-2 group , n = 334 ) .
METHODS	Exclusion criteria included : a history of neurologic or mental disease , renal failure , active liver disease , cardiac or pulmonary dysfunction , endocrine , metabolic , or peptic ulcer disease , a history of past surgery , < 6 years of schooling , inability to complete neuropsychological testing , visual dysfunction , and auditory dysfunction .
METHODS	Patients were also excluded at any point if additional steroid was required .
METHODS	Propofol and sufentanil were administered for anesthetic induction , whereas propofol and remifentanil were given for maintenance of anesthesia .
METHODS	A battery of 9 neuropsychological tests was administered preoperatively and the on day 5 postoperatively .
METHODS	A postoperative deficit was defined as a postoperative decrement to preoperative score of > 1SD on any test .
METHODS	Patients who experienced > 2 deficits were considered to have experienced early POCD .
RESULTS	Nine hundred and fifty-four patients completed both preoperative and postoperative neuropsychological testing .
RESULTS	Within the 3 groups : Dex-0 group , n = 319 ; Dex-1 group , n = 320 and Dex-2 , n = 315 .
RESULTS	POCD occurred in 71 patients ( 22.3 % ) in the Dex-0 group , in 66 patients ( 20.6 % ) in the Dex-1 group , and 99 patients ( 31.4 % ) in the Dex-2 group .
RESULTS	POCD was significant among the 3 groups ( P = 0.003 ) .
RESULTS	Partitions of method was applied for multiple comparisons showing that Dex-2 group was significantly different from Dex-1 and Dex-0 groups .
CONCLUSIONS	Administration of higher dose of dexamethasone ( 0.2 mg/kg ) increases the incidence of POCD in the early postoperative period after microvascular decompression under general anesthesia .

###24920292
BACKGROUND	Irisin , a recently discovered myokine , has been shown to induce browning of white adipose tissue , enhancing energy expenditure and mediating some of the beneficial effects of exercise .
BACKGROUND	We aimed to estimate the time frame of changes in irisin levels after acute exercise and the effect of different exercise workloads and intensities on circulating irisin levels immediately post-exercise .
METHODS	In a pilot study , four healthy subjects ( 22.51.7 years ) underwent maximal workload exercise ( maximal oxygen consumption , VO2 max ) and blood was drawn at prespecified intervals to define the time frame of pre - and post-exercise irisin changes over a 24-h period .
METHODS	In the main study , 35 healthy , non-smoking ( 23.03.3 years ) men and women ( n = 20/15 ) underwent three exercise protocols 48-h apart , in random order : i ) maximal workload ( VO2 max ) ; ii ) relative workload ( 70 % of VO2 max/10min ) ; and iii ) absolute workload ( 75W/10min ) .
METHODS	Blood was drawn immediately pre-exercise and 3min post-exercise .
RESULTS	In the pilot study , irisin levels increased by 35 % 3min post-exercise , then dropped and remained relatively constant .
RESULTS	In the main study , irisin levels post-exercise were significantly higher than those of pre-exercise after all workloads ( all , P < 0.001 ) .
RESULTS	Post-to-pre-exercise differences in irisin levels were significantly different between workloads ( P = 0.001 ) , with the greatest increase by 34 % following maximal workload ( P = 0.004 vs relative and absolute ) .
CONCLUSIONS	Circulating irisin levels were acutely elevated in response to exercise , with a greater increase after maximal workload .
CONCLUSIONS	These findings suggest that irisin release could be a function of muscle energy demand .
CONCLUSIONS	Future studies need to determine the underlying mechanisms of irisin release and explore irisin 's therapeutic potential .

###24526745
BACKGROUND	Benzodiazepines are extensively used in primary care , but their long-term use is associated with adverse health outcomes and dependence .
OBJECTIVE	To analyse the efficacy of two structured interventions in primary care to enable patients to discontinue long-term benzodiazepine use .
METHODS	A multicentre three-arm cluster randomised controlled trial was conducted , with randomisation at general practitioner level ( trial registration ISRCTN13024375 ) .
METHODS	A total of 532 patients taking benzodiazepines for at least 6 months participated .
METHODS	After all patients were included , general practitioners were randomly allocated ( 1:1:1 ) to usual care , a structured intervention with follow-up visits ( SIF ) or a structured intervention with written instructions ( SIW ) .
METHODS	The primary end-point was the last month self-declared benzodiazepine discontinuation confirmed by prescription claims at 12 months .
RESULTS	At 12 months , 76 of 168 ( 45 % ) patients in the SIW group and 86 of 191 ( 45 % ) in the SIF group had discontinued benzodiazepine use compared with 26 of 173 ( 15 % ) in the control group .
RESULTS	After adjusting by cluster , the relative risks for benzodiazepine discontinuation were 3.01 ( 95 % CI 2.03-4 .46 , P < 0.0001 ) in the SIW and 3.00 ( 95 % CI 2.04-4 .40 , P < 0.0001 ) in the SIF group .
RESULTS	The most frequently reported withdrawal symptoms were insomnia , anxiety and irritability .
CONCLUSIONS	Both interventions led to significant reductions in long-term benzodiazepine use in patients without severe comorbidity .
CONCLUSIONS	A structured intervention with a written individualised stepped-dose reduction is less time-consuming and as effective in primary care as a more complex intervention involving follow-up visits .

###24510471
OBJECTIVE	Memantine , an uncompetitive antagonist of N-methyl-d-aspartate receptors , may have a role in managing symptoms associated with dementia in Parkinson 's disease ( PDD ) , although its role in improving patient-reported outcomes ( PROs ) has not been extensively investigated .
OBJECTIVE	PROs may be more sensitive than standard psychometric measures for detecting change in complex conditions such as PDD .
OBJECTIVE	The aim of this study was to examine the effect of memantine on PROs : individually determined goals and health-related quality of life .
OBJECTIVE	We also examined memantine 's effect on caregiver burden .
METHODS	This 22-week double-blind randomised controlled trial evaluated participants with PDD on 20mg of memantine or placebo .
METHODS	Outcome measures were Goal Attainment Scaling ( GAS ) , the Parkinson 's Disease Questionnaire-8 and the Zarit Burden Inventory .
RESULTS	A significantly greater proportion of participants on memantine ( 64 % ) had better than expected GAS outcomes compared with those on placebo ( 7 % ) ( p = 0.007 ) .
RESULTS	Furthermore , the improvement in mean GAS score , as well as mean caregiver burden score , from baseline to drug discontinuation was significantly greater in those on memantine compared with those on placebo ( p = 0.03 and 0.04 , respectively ) .
RESULTS	Significant differences in quality of life were not seen .
CONCLUSIONS	In this study , memantine improved individually set goals and caregiver burden in PDD .
CONCLUSIONS	This suggests that clinimetric measures such as GAS may be more sensitive than conventional psychometric measures in detecting improvements in people with PDD .

###25421363
BACKGROUND	Fatigue is a common yet difficult to treat condition in primary care .
BACKGROUND	The objective of this study is to evaluate the cost-effectiveness of a brief cognitive behavioral therapy ( CBT ) based fatigue self-management ( FSM ) intervention as compared to usual care among patients with chronic fatigue in primary care .
METHODS	An economic evaluation alongside of a parallel randomized controlled study design was used .
METHODS	Computer-generated variable-sized block randomization plan was used to assign patients into treatment groups and data collection staff were blinded to group assignments .
METHODS	Patients aged between 18 and 65 years with at least six months of persistent fatigue and no medical or psychiatric exclusions were enrolled from a large primary care practice in Stony Brook , New York .
METHODS	The FSM group ( n = 37 ) received two sessions of a nurse-delivered , fatigue self-management protocol and a self-help book and the usual care group ( n = 36 ) received regular medical care .
METHODS	The effectiveness measure was the Fatigue Severity Scale and the cost measure was total health care expenditures derived from monthly health services use diaries during follow-up .
METHODS	A societal perspective was adopted and bootstrapped incremental cost-effectiveness ratios ( ICERs ) and net monetary benefit ( NMB ) were calculated as measures of cost-effectiveness .
RESULTS	The ICER for FSM was - $ $ 2358 , indicating that FSM dominates UC and it may generate societal cost savings as compared to usual care .
RESULTS	Complete case analysis yielded smaller ICER ( - $ 1199 ) with greater uncertainties .
RESULTS	Net monetary benefit analysis showed that FSM has a probability of 0.833 ( 95 % CI : 0.819 , 0.847 ) to achieve positive NMB and the favorable results were not sensitive to assumptions about informal care or treatment costs .
CONCLUSIONS	This economic evaluation found initial evidence that a two-session brief CBT-based FSM may be cost-effective as compared to usual care over 12 months .
CONCLUSIONS	The FSM intervention is potentially a promising intervention for chronic fatigue patients in primary care .
CONCLUSIONS	Additional research is needed to examine the reproducibility and generalizability of these findings .
BACKGROUND	ClinicalTrials.gov ( NCT00997451 , March 28 , 2009 ) .

###24249840
BACKGROUND	The purpose of this study was to evaluate the effect of a physical activity telemonitoring program on daily physical activity level , oxygen uptake capacity ( VO ( 2peak ) ) , and cardiovascular risk profile in coronary artery disease ( CAD ) patients who completed phase II cardiac rehabilitation ( CR ) .
METHODS	Eighty CAD patients who completed phase II CR were randomly assigned to an additional telemonitoring intervention or standard CR .
METHODS	The patients in the intervention group ( n = 40 ) wore a motion sensor continuously for 18 weeks .
METHODS	Each week these patients received a step count goal , with the aim to gradually increase the patients ' physical activity level .
METHODS	In the control group ( n = 40 ) , the patients wore an unreadable motion sensor for seven days for measurement purposes only ( at start of follow-up , and after six and 18 weeks ) .
METHODS	At start of follow-up and after 18 weeks blood lipid profile , glycemic control , waist circumference and body mass index was assessed .
METHODS	VO ( 2peak ) was assessed at start of follow-up , and after six and 18 weeks .
METHODS	Re-hospitalisation rate was followed during this timeframe .
RESULTS	In the intervention group , VO ( 2peak ) increased significantly during follow-up ( P = 0.001 ) , in the control group it did not ( P = 0.273 ) .
RESULTS	A significant correlation was found between daily aerobic step count and improvement in VO ( 2peak ) ( P = 0.030 , r = 0.47 ) .
RESULTS	Kaplan-Meier curve analysis showed a trend towards fewer re-hospitalisations for patients in the telemonitoring group ( P = 0.09 ) .
CONCLUSIONS	The study showed that , to maintain exercise tolerance and lower re-hospitalisation rate after hospital-based CR in CAD patients , a physical activity telemonitoring program might be an effective intervention .

###24343688
OBJECTIVE	To compare the effects of different levels of positive end-expiratory pressure on respiratory mechanics and oxygenation indexes in the immediate postoperative period of coronary artery bypass grafting .
METHODS	Randomized clinical trial in which 136 patients underwent coronary artery bypass grafting between January 2011 and March 2012 were divided into three groups and admitted to mechanical ventilation with different positive end-expiratory pressure levels : Group A , 5 cmH2O ( n = 44 ) , Group B , 8 cmH2O ( n = 47 ) and Group C , 10 cmH2O ( n = 45 ) .
METHODS	Data about respiratory mechanics were obtained from mechanical ventilator monitor and oxygenation indexes from arterial blood gas samples , collected twenty minutes after intensive care unit admission .
METHODS	Patients with chronic obstructive pulmonary disease and patients submitted to off-pump , emergency or combined operations were not included .
METHODS	For statistical analysis , we used Kruskal-Wallis , G and Chi-square tests , considering results significant when P < 0.05 .
RESULTS	Groups were homogeneous in terms of demographic , clinical and surgical variables .
RESULTS	Patients ventilated with positive end-expiratory pressure of 10 cmH2O ( Group C ) had best compliance ( P = 0.04 ) and airway resistance values , this , however , without statistical significance .
RESULTS	They also had best oxygenation indexes , with statistical difference in all analyzed variables , and lower frequency of hypoxemia ( P = 0.03 ) .
CONCLUSIONS	Higher levels of positive end-expiratory pressure in immediate postoperative period of coronary artery bypass grafting improved pulmonary compliance values and increased oxygenation indexes , resulting in lower frequency of hypoxemia .

###26209856
BACKGROUND	Delirium is a common complication after cardiac surgery and may be as a result of inadequate cerebral perfusion .
BACKGROUND	We studied delirium after cardiac surgery in relation to intraoperative hypotension ( IOH ) .
METHODS	This observational single-centre , cohort study was nested in a randomized trial , on a single intraoperative dose of dexamethasone vs placebo during cardiac surgery .
METHODS	During the first four postoperative days , patients were screened for delirium based on the Confusion Assessment Method ( CAM ) for Intensive Care Unit on the intensive care unit , CAM on the ward , and by inspection of medical records .
METHODS	To combine depth and duration of IOH , we computed the area under the curve for four blood pressure thresholds .
METHODS	Logistic regression analyses were performed to investigate the association between IOH and the occurrence of postoperative delirium , adjusting for confounding and using a 99 % confidence interval to correct for multiple testing .
RESULTS	Of the 734 included patients , 99 patients ( 13 % ) developed postoperative delirium .
RESULTS	The adjusted Odds Ratio for the Mean Arterial Pressure < 60 mm Hg threshold was 1.04 ( 99 % confidence interval : 0.99-1 .10 ) for each 1000 mm Hg ( 2 ) min ( 2 ) AUC ( 2 ) increase .
RESULTS	IOH , as defined according to the other three definitions , was not associated with postoperative delirium either .
RESULTS	Deep and prolonged IOH seemed to increase the risk of delirium , but this was not statistically significant .
CONCLUSIONS	Independent of the applied definition , IOH was not associated with the occurrence of delirium after cardiac surgery .

###24902881
OBJECTIVE	This study sought to determine the most effective technique for Valsalva Manoeuvre ( VM ) and Human Dive Reflex Manoeuvre ( HDR ) generation of vagal tone .
METHODS	We conducted a repeated-measures trial of healthy adult volunteers from a university campus , aged 18-56years , in sinus rhythm .
METHODS	Participants were randomised to VM ( in supine or Trendelenberg postures ) and HDR ( supine or sitting postures ) sequentially .
METHODS	Participants performed three trials of each technique , in random order , with a continuous ECG recording .
METHODS	Single-blinded analysis of ECG data was conducted .
METHODS	Mean differences between premanoeuvre and postmanoeuvre R-R intervals and heart rates were calculated for each posture within and between vagal manoeuvres .
RESULTS	Seventy-two participants were enrolled .
RESULTS	The difference between VM ( supine ) and VM ( Trendelenberg ) was not significant at 0.008 s ( -0.023 to 0.038 ) .
RESULTS	The difference in mean R-R intervals for HDR ( supine ) was greater than HDR ( sitting ) 0.062 ( 0.031 to 0.093 ) , although this significance was not reflected in a heart-rate change of -0.87 ( -3.00 to 1.26 ) .
RESULTS	VM supine generated greatest overall mean R-R interval difference , while HDR ( sitting ) provided the smallest change in R-R interval .
RESULTS	The VM ( supine ) provided a significant maximum effectiveness over the HDR ( supine ) of 0.102 s ( 0.071 to 0.132 ) .
CONCLUSIONS	This study demonstrates that VM ( supine ) generates the greatest vagal tone producing the largest transient heart rate decrease in healthy volunteers .
CONCLUSIONS	No advantage was identified in Trendelenberg posturing for the VM in this study .
CONCLUSIONS	These results may assist in the standardisation of vagal manoeuvre technique for the range of therapeutic and diagnostic applications .

###25081728
BACKGROUND	Traditional Chinese Medicine ( TCM ) possesses several advantages for treating patients with hepatocellular carcinoma ( HCC ) .
BACKGROUND	The theory of ` Jianpi Huayu Therapy ' rooted from ` Jin Kui Yao Lue ' is one of the most important therapies in this respect .
BACKGROUND	This study was conducted to investigate the clinical effect and safety of hepatectomy combining with ` Jianpi Huayu Therapy ' in the treatment of HCC .
METHODS	One hundred and twenty patients with HCC were randomized allocated into hepatectomy combined with ` Jianpi Huayu Therapy ' group ( treatment group , n = 60 ) and hepatectomy alone group ( control group , n = 60 ) .
METHODS	Disease-free survival ( DFS ) and overall survival ( OS ) were the primary end-points .
METHODS	Liver function at the end of one week after surgery , complications , average days of hospitalization as well as performance status ( PS ) at the end of one month post operation were also compared .
RESULTS	No significant differences existed between two groups on baseline analysis ( p > 0.05 ) .
RESULTS	No treatment related mortality occurred in either group .
RESULTS	Post-operative complications were detected among 14 patients ( 23.3 % ) in the treatment group , and 12 ( 20.0 % ) in the control group ( p = 0.658 ) .
RESULTS	Alanine aminotransferase ( ALT ) at the end of one week after operation was lower in the treatment than control groups ( p = 0.042 ) .
RESULTS	No significant differences in other indexes of liver function were discovered between two groups .
RESULTS	Average days of hospitalization reduced by 0.9 day in treatment group than in control ( p = 0.034 ) .
RESULTS	During follow-up , 104 patients ( 86.6 % ) developed recurrence .
RESULTS	The rates of 1 - , 3 - , and 5-year DFS and median DFS for all patients were 77.4 % , 26.3 % , 9.0 % and 25.6 months ( range , 6.0 ~ 68.0 ) , respectively ( 78.2 % , 29.2 % , 14.3 % and 28.7 months for the 48 patients in the treatment group and 75.0 % , 23.3 % , 6.4 % , and 22.6 months for the 56 patients in the control group ( p = 0.045 ) ) .
RESULTS	101 patients had died at the time of censor , with 1 - , 3 - , and 5-year overall survival rates and median survival for all patients of 97.5 % , 76.4 % , 40.5 % and 51.2 months ( range , 10.0 ~ 72.0 ) , respectively ( 98.3 % , 78.0 % , 43.6 % and 52.6 months , for treatment and 96.7 % , 74.7 % , 37.4 % , and 49.8 months , for controls , respectively ( p = 0.048 ) ) .
CONCLUSIONS	Hepatectomy combined with ` Jianpi Huayu therapy ' was effective in the treatment of HCC , and reduced post-operative recurrence and metastasis and improved DFS and OS of HCC patients .

###25444377
OBJECTIVE	The use of second-generation drug-eluting stents compared with bare-metal stents in patients with ST-segment elevation myocardial infarction reduces the rate of major adverse cardiac events .
OBJECTIVE	We aimed to evaluate the impact of sex on the performance of everolimus-eluting stents vs bare-metal stents in ST-segment elevation myocardial infarction at 2-year follow-up .
METHODS	This is a sub-study of the EXAMINATION trial that randomized 1498 patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention to everolimus-eluting or bare-metal stents .
METHODS	Primary end point was combined all-cause death , any recurrent myocardial infarction , and any revascularization .
METHODS	All end points were analyzed according to sex at 2-year follow-up .
RESULTS	Of 1498 patients included in the trial , 254 ( 17.0 % ) were women .
RESULTS	Women were older and had higher prevalence of hypertension and lower prevalence of smoking compared with men .
RESULTS	In contrast with men , stent diameter was smaller in women .
RESULTS	After multivariate analysis , the primary end point was similar between women and men ( hazard ratio = 0.95 ; 95 % confidence interval , 0.66-1 .37 ) , and among women , between those treated with bare-metal vs everolimus-eluting stents ( hazard ratio = 2.48 ; 95 % confidence interval , 0.95-6 .46 ) .
RESULTS	Women showed a lower rate of repeat revascularization than men ( hazard ratio = 0.55 ; 95 % confidence interval , 0.32-0 .95 ) despite worse baseline characteristics .
RESULTS	This difference was driven by better performance of the everolimus-eluting stent in women .
CONCLUSIONS	Despite poorer baseline clinical characteristics , women with ST-segment elevation myocardial infarction treated with percutaneous coronary intervention showed outcomes similar to men .
CONCLUSIONS	The use of everolimus-eluting stents may represent an added value in women as it showed a reduced rate of repeated revascularization compared to men .

###25332321
BACKGROUND	Emerging cellular markers of endothelial damage and repair include endothelial microparticles ( EMPs ) and endothelial progenitor cells ( EPCs ) , respectively .
BACKGROUND	Effects of long-chain ( LC ) n-3 ( omega-3 ) polyunsaturated fatty acids ( PUFAs ) and the influence of genetic background on these markers are not known .
OBJECTIVE	We investigated effects of fish-oil supplementation on both classical and novel markers of endothelial function in subjects prospectively genotyped for the Asp298 endothelial nitric oxide synthase ( eNOS ) polymorphism and at moderate risk of cardiovascular disease ( CVD ) .
METHODS	A total of 84 subjects with moderate risk of CVD ( GG : n = 40 ; GT/TT : n = 44 ) completed a randomized , double-blind , placebo-controlled , 8-wk crossover trial of fish-oil supplementation that provided 1.5 g LC n-3 PUFAs/d .
METHODS	Effects of genotype and fish-oil supplementation on the blood lipid profile , inflammatory markers , vascular function ( by using peripheral artery tonometry ) , and numbers of circulating EPCs and EMPs ( by using flow cytometry ) were assessed .
RESULTS	There was no significant effect of fish-oil supplementation on blood pressure , plasma lipids , or plasma glucose , although there was a trend ( P = 0.069 ) toward a decrease in the plasma triglyceride concentration after fish-oil supplementation compared with placebo treatment .
RESULTS	GT/TT subjects tended to have higher concentrations of total cholesterol and low-density lipoprotein cholesterol , but vascular function was not affected by either treatment or eNOS genotype .
RESULTS	Biochemical markers of endothelial function were also unaffected by treatment and eNOS genotype .
RESULTS	In contrast , there was a significant effect of fish-oil supplementation on cellular markers of endothelial function .
RESULTS	Fish-oil supplementation increased numbers of EPCs and reduced numbers of EMPs relative to those with placebo treatment , which potentially favored the maintenance of endothelial integrity .
RESULTS	There was no influence of genotype for any cellular markers of endothelial function , which indicated that effects of fish-oil supplementation were independent of eNOS genotype .
CONCLUSIONS	Emerging cellular markers of endothelial damage , integrity , and repair appear to be sensitive to potentially beneficial modification by dietary n-3 PUFAs .
CONCLUSIONS	This trial was registered at www.controlled-trials.com/isrctn as ISRCTN76272133 .

###26039929
BACKGROUND	Data are limited on effects of household or community support persons ( `` care buddies '' ) on enrollment into and adherence to pre-antiretroviral HIV care .
BACKGROUND	We assessed the impact of care buddies on adherence to HIV clinic appointments , HIV progression , and conduct of daily life among pre-antiretroviral therapy ( pre-ART ) HIV-infected individuals in Rakai , Uganda .
METHODS	A total of 1209 HIV-infected pre-ART patients aged 15 years were randomized to standard of care ( SOC ) ( n = 604 ) or patient-selected care buddy ( PSCB ) ( n = 605 ) and followed at 6 and 12 months .
METHODS	Outcomes were adherence to clinic visits , HIV disease progression , and self-reported conduct of daily life .
METHODS	Incidence and prevalence rate ratios and 95 % confidence intervals ( CIs ) were used to assess outcomes in the intent-to-treat and as-treated analyses .
RESULTS	Baseline characteristics were comparable .
RESULTS	In the intent to treat analysis , both arms were comparable with respect to adherence to CD4 monitoring visits [ adjusted prevalence risk ratio ( adjPRR ) , 0.98 ; 95 % CI : 0.93 to 1.04 ; P = 0.529 ] , and ART eligibility ( adjPRR , 1.00 ; 95 % CI : 0.77 to 1.31 ; P = 0.946 ) .
RESULTS	Good conduct of daily life was significantly higher in the PSCB than the SOC arm ( adjPRR , 1.08 ; 95 % CI : 1.03 to 1.13 ; P = 0.001 ) .
RESULTS	More men ( 61 % ) compared with women ( 30 % ) selected spouses/partners as buddies ( P < 0.0001 ) .
RESULTS	Twenty-two percent of PSCB arm participants discontinued use of buddies .
CONCLUSIONS	In pre-ART persons , having care buddies improved the conduct of daily life of the HIV-infected patients but had no effect on HIV disease progression and only limited effect on clinic appointment adherence .

###24643443
BACKGROUND	Reproductive health and sexually transmitted diseases ( STD ) account for a high proportion of health problems in the rural-to-urban young female migrant workers in China .
BACKGROUND	Improving these conditions remains highly challenging .
OBJECTIVE	To developed an educational programme to advance the reproductive health of the female workers .
METHODS	An intervention study was conducted between July 2010 and April 2011 in Shenzhen .
METHODS	Two commune factories were selected to participate and provided a control cluster receiving routine local government health services and a second cluster receiving an educational intervention in addition to the routine services .
METHODS	The intervention included distribution and free access to educational study materials .
METHODS	The factory workers ' knowledge , attitudes and behaviour in the area of reproductive health and STD were the main study outcomes .
RESULTS	Compared with the control cluster , at the 6-month follow-up assessment , the intervention cluster had a significantly higher proportion of correct answers to queries about human immunodeficiency virus/acquired immunodeficiency syndrome ( HIV/AIDS ) ( standardised coefficients of multiple linear regression ( B ) 0.047 ; P = 0.020 ) and awareness of places providing free contraceptives ( odds ratio [ OR ] 2.011 , 95 % confidence interval [ CI ] 1.635-2 .472 ; P < 0.001 ) , and a significantly lower proportion accepting premarital sex ( OR 0.492 , 95 % CI 0.416-0 .582 ; P < 0.001 ) , practising premarital sex ( OR 0.539 , 95 % CI 0.478-0 .608 ; P < 0.001 ) or suffering from gynaecological disorders ( OR 0.801 , 95 % CI 0.697-0 .921 ; P = 0.002 ) .
CONCLUSIONS	A community-based educational intervention targeting unmarried female migrant workers appears to be effective in substantially improving their knowledge of reproductive health and their attitudes and behaviour towards health , and in reducing prevalence of STD .

###24875032
BACKGROUND	Antifibrinolytics can reduce intraoperative blood loss .
BACKGROUND	The primary aim of this study was to determine the efficacy of intraoperative tranexamic acid , epsilon-aminocaproic acid , and placebo at reducing perioperative blood loss and the transfusion rate in patients with adolescent idiopathic scoliosis undergoing posterior spinal arthrodesis .
METHODS	This is a prospective , randomized , double-blind comparison of tranexamic acid , epsilon-aminocaproic acid , and placebo used intraoperatively in patients with adolescent idiopathic scoliosis .
METHODS	One hundred and twenty-five patients with adolescent idiopathic scoliosis were randomly assigned to the tranexamic acid , epsilon-aminocaproic acid , or control groups .
METHODS	Parameters recorded included estimated blood loss , hematocrit , blood product usage , drain output , and total blood losses .
METHODS	The primary outcomes were intraoperative blood loss and postoperative drainage .
METHODS	Secondary outcomes were transfusion requirements and hematocrit changes both intraoperatively and postoperatively .
RESULTS	One hundred and twenty-five patients ( ninety-seven female and twenty-eight male , with a mean age of fifteen years ) were randomized to receive tranexamic acid ( thirty-six patients ) , epsilon-aminocaproic acid ( forty-two patients ) , or saline solution ( forty-seven patients ) .
RESULTS	The groups were similar at baseline , with one exception : the saline solution group had a higher estimated blood volume at baseline than the tranexamic acid group .
RESULTS	Both tranexamic acid and epsilon-aminocaproic acid reduced the estimated blood loss per degree and estimated blood loss per pedicle screw .
RESULTS	Epsilon-aminocaproic acid , but not tranexamic acid , reduced estimated blood loss and estimated blood loss per level .
RESULTS	Tranexamic acid also reduced total blood losses compared with epsilon-aminocaproic acid or saline solution .
RESULTS	In an analysis controlling for level , degree , and number of anchors , tranexamic acid reduced drain output and total blood losses .
RESULTS	Tranexamic acid or epsilon-aminocaproic acid had a smaller decrease in hematocrit postoperatively .
RESULTS	In an analysis controlling for the mean arterial pressure during surgical exposure , tranexamic acid reduced estimated blood loss and total blood losses .
RESULTS	Overall , antifibrinolytics ( tranexamic acid or epsilon-aminocaproic acid ) reduced estimated blood loss , total blood losses , and the decline in hematocrit postoperatively compared with saline solution .
RESULTS	There was no difference among the groups with respect to the transfusion rate , duration of surgery , levels fused , or pedicle screws placed .
CONCLUSIONS	Tranexamic acid and epsilon-aminocaproic acid reduced operative blood loss but not transfusion rate .
CONCLUSIONS	Tranexamic acid is more effective at reducing postoperative drainage and total blood losses compared with epsilon-aminocaproic acid .
CONCLUSIONS	Maintenance of the mean arterial pressure at < 75 mm Hg during surgical exposure appears to be critical for maximizing antifibrinolytic benefit .
METHODS	Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence .

###24347422
OBJECTIVE	Randomized clinical trials show higher 30-day risk of stroke or death after carotid artery stenting compared with surgery .
OBJECTIVE	We examined whether operator experience is associated with 30-day risk of stroke or death in the Carotid Stenting Trialists ' Collaboration database .
METHODS	The Carotid Stenting Trialists ' Collaboration is a pooled individual patient database including all patients recruited in 3 randomized trials of stenting versus endarterectomy for symptomatic carotid stenosis ( Endarterectomy Versus Angioplasty in patients with Symptomatic Severe Carotid Stenosis trial , Stent-Protected Angioplasty versus Carotid Endarterectomy trial , and International Carotid Stenting Study ) .
METHODS	Lifetime carotid artery stenting experience , lifetime experience in stenting procedures excluding the carotid , and annual number of procedures performed within the trial ( in-trial volume ) , divided into tertiles , were used to measure operator experience .
METHODS	The outcome event was the occurrence of any stroke or death within 30 days of the procedure .
METHODS	The analysis was done per protocol .
RESULTS	Among 1546 patients who underwent carotid artery stenting , 120 ( 7.8 % ) had a stroke or death within 30 days of the procedure .
RESULTS	The 30-day risk of stroke or death did not differ according to operator lifetime carotid artery stenting experience ( P = 0.8 ) or operator lifetime stenting experience excluding the carotid ( P = 0.7 ) .
RESULTS	In contrast , the 30-day risk of stroke or death was significantly higher in patients treated by operators with low ( mean 3.2 procedures/y ; risk 10.1 % ; adjusted risk ratio = 2.30 [ 1.36-3 .87 ] ) and intermediate annual in-trial volumes ( 3.2-5 .6 procedures/y ; 8.4 % ; adjusted risk ratio = 1.93 [ 1.14-3 .27 ] ) compared with patients treated by high annual in-trial volume operators ( > 5.6 procedures/y ; 5.1 % ) .
CONCLUSIONS	Carotid stenting should only be performed by operators with annual procedure volume 6 cases per year .

###24268395
OBJECTIVE	The aim of this study was to evaluate occlusion rates of great saphenous veins ( GSV ) with a diameter between 5-10 mm that received a pre-treatment size reduction via perivenous tumescent application ( TA ) followed by catheter-directed foam sclerotherapy ( CDFS ) .
METHODS	A prospective blinded randomized clinical trial comparing the occlusion rates of GSV at 1 - , 6 - , and 12-month follow-up .
METHODS	Fifty patients were included and randomized into two groups .
METHODS	CDFS was performed accessing the GSV at knee level and applying 8 mL of 2 % polidocanol-foam ( EasyFoam ) while the catheter was withdrawn .
METHODS	Strictly perivenous TA was performed in group 1 before applying the sclerosant agent .
METHODS	Occlusion rates and clinical scores were assessed by blinded examiners .
RESULTS	After 12 months in group 1 full occlusion was achieved in 73.9 % , partial occlusion in 8.7 % , and 17.4 % were classified as treatment failure .
RESULTS	In group 2 , 75 % of the targeted GSV were fully occluded , 20 % were partially occluded , and 5 % were diagnosed as treatment failure .
RESULTS	Both groups showed a significant reduction of the vein diameter .
RESULTS	Patient 's tolerance and satisfaction with the treatment was high in both groups .
CONCLUSIONS	No benefit could be found using additional TA to reduce the vein diameter before the treatment .

###24934787
OBJECTIVE	Optimal adjuvant chemotherapy for early-stage breast cancer balances efficacy and toxicity .
OBJECTIVE	We sought to determine whether single-agent paclitaxel ( T ) was inferior to doxorubicin and cyclophosphamide ( AC ) , when each was administered for four or six cycles of therapy , and whether it offered less toxicity .
METHODS	Patients with operable breast cancer with 0 to 3 positive nodes were enrolled onto the study to address the noninferiority of single-agent T to AC , defined as the one-sided 95 % upper-bound CI ( UCB ) of hazard ratio ( HR ) of T versus AC less than 1.30 for the primary end point of relapse-free survival ( RFS ) .
METHODS	As a 2 2 factorial design , duration of therapy was also addressed and was previously reported .
RESULTS	With 3,871 patients enrolled onto the trial , a median follow-up period of 6.1 years , and 437 RFS events , we achieved an HR of 1.26 ( one sided 95 % UCB , 1.48 ; favoring AC does not allow a conclusion of noninferiority of T with AC ; UCB > 1.3 ) .
RESULTS	With 266 patient deaths , the HR for overall survival ( OS ) was 1.27 favoring AC ( UCB , 1.56 ) .
RESULTS	The estimated absolute advantage of AC at 5 years is 3 % for RFS ( 91 v 88 % ) and 1 % for OS ( 95 v 94 % ) .
RESULTS	All nine treatment-related deaths were patients receiving AC and are included in the analyses of both RFS and OS .
RESULTS	Hematologic toxicity was more common in patients treated with AC , and neuropathy was more common in patients treated with T.
CONCLUSIONS	This trial did not show noninferiority of T to AC , a conclusion that is unlikely to change with additional events and follow-up .
CONCLUSIONS	T was less toxic than AC .

###25070302
OBJECTIVE	Adenotonsillectomy for obstructive sleep apnea syndrome ( OSAS ) may lead to weight gain , which can have deleterious health effects when leading to obesity .
OBJECTIVE	However , previous data have been from nonrandomized uncontrolled studies , limiting inferences .
OBJECTIVE	This study examined the anthropometric changes over a 7-month interval in a randomized controlled trial of adenotonsillectomy for OSAS , the Childhood Adenotonsillectomy Trial .
METHODS	A total of 464 children who had OSAS ( average apnea/hypopnea index [ AHI ] 5.1 / hour ) , aged 5 to 9.9 years , were randomized to Early Adenotonsillectomy ( eAT ) or Watchful Waiting and Supportive Care ( WWSC ) .
METHODS	Polysomnography and anthropometry were performed at baseline and 7-month follow-up .
METHODS	Multivariable regression modeling was used to predict the change in weight and growth indices .
RESULTS	Interval increases in the BMI z score ( 0.13 vs. 0.31 ) was observed in both the WWSC and eAT intervention arms , respectively , but were greater with eAT ( P < .0001 ) .
RESULTS	Statistical modeling showed that BMI z score increased significantly more in association with eAT after considering the influences of baseline weight and AHI .
RESULTS	A greater proportion of overweight children randomized to eAT compared with WWSC developed obesity over the 7-month interval ( 52 % vs. 21 % ; P < .05 ) .
RESULTS	Race , gender , and follow-up AHI were not significantly associated with BMI z score change .
CONCLUSIONS	eAT for OSAS in children results in clinically significant greater than expected weight gain , even in children overweight at baseline .
CONCLUSIONS	The increase in adiposity in overweight children places them at further risk for OSAS and the adverse consequences of obesity .
CONCLUSIONS	Monitoring weight , nutritional counseling , and encouragement of physical activity should be considered after eAT for OSAS .

###24704090
BACKGROUND	Vulvar lichen sclerosus is a chronic condition usually responsive to topical corticosteroids .
OBJECTIVE	We sought to evaluate the efficacy ( reduction of signs and symptoms ) and safety of clobetasol propionate 0.05 % and tacrolimus 0.1 % in the treatment of vulvar lichen sclerosus .
METHODS	This double-blind , randomized study comparing 2 treatments over a 3-month period , enrolled 58 female patients with newly diagnosed vulvar lichen sclerosus or untreated vulvar lichen sclerosus for at least 1 month .
RESULTS	In all , 55 patients were included in the statistical analysis .
RESULTS	A total of 28 patients were assigned to the tacrolimus group and 27 patients to the clobetasol group .
RESULTS	Both groups showed a significant difference in the decrease of symptoms and signs of lichen sclerosus .
RESULTS	At the end of the study , 28 participants ( 19tacrolimus and 9 clobetasol ) still had some clinical signs of lichen sclerosus ( ( 2 ) = 6.56 , P = .015 ) .
RESULTS	However , a significantly higher number of patients in the clobetasol group ( n = 15 ) had absence of signs and symptoms of lichen sclerosus ( ( 2 ) = 10.35 , P = .002 ; ( 2 ) = 10.35 , P = .002 ) .
RESULTS	No adverse events were reported .
CONCLUSIONS	Short length of trial and recruitment through our vulvar disease referral center are limitations .
CONCLUSIONS	This study showed that topical clobetasol propionate was significantly more effective in treating vulvar lichen sclerosus than topical tacrolimus .

###25154822
OBJECTIVE	Combining cisplatin or cetuximab with radiation improves overall survival ( OS ) of patients with stage III or IV head and neck carcinoma ( HNC ) .
OBJECTIVE	Cetuximab plus platinum regimens also increase OS in metastatic HNC .
OBJECTIVE	The Radiation Therapy Oncology Group launched a phase III trial to test the hypothesis that adding cetuximab to the radiation-cisplatin platform improves progression-free survival ( PFS ) .
METHODS	Eligible patients with stage III or IV HNC were randomly assigned to receive radiation and cisplatin without ( arm A ) or with ( arm B ) cetuximab .
METHODS	Acute and late reactions were scored using Common Terminology Criteria for Adverse Events ( version 3 ) .
METHODS	Outcomes were correlated with patient and tumor features and markers .
RESULTS	Of 891 analyzed patients , 630 were alive at analysis ( median follow-up , 3.8 years ) .
RESULTS	Cetuximab plus cisplatin-radiation , versus cisplatin-radiation alone , resulted in more frequent interruptions in radiation therapy ( 26.9 % v. 15.1 % , respectively ) ; similar cisplatin delivery ( mean , 185.7 mg/m2 v. 191.1 mg/m2 , respectively ) ; and more grade 3 to 4 radiation mucositis ( 43.2 % v. 33.3 % , respectively ) , rash , fatigue , anorexia , and hypokalemia , but not more late toxicity .
RESULTS	No differences were found between arms A and B in 30-day mortality ( 1.8 % v. 2.0 % , respectively ; P = .81 ) , 3-year PFS ( 61.2 % v. 58.9 % , respectively ; P = .76 ) , 3-year OS ( 72.9 % v. 75.8 % , respectively ; P = .32 ) , locoregional failure ( 19.9 % v. 25.9 % , respectively ; P = .97 ) , or distant metastasis ( 13.0 % v. 9.7 % , respectively ; P = .08 ) .
RESULTS	Patients with p16-positive oropharyngeal carcinoma ( OPC ) , compared with patients with p16-negative OPC , had better 3-year probability of PFS ( 72.8 % v. 49.2 % , respectively ; P < .001 ) and OS ( 85.6 % v. 60.1 % , respectively ; P < .001 ) , but tumor epidermal growth factor receptor ( EGFR ) expression did not distinguish outcome .
CONCLUSIONS	Adding cetuximab to radiation-cisplatin did not improve outcome and hence should not be prescribed routinely .
CONCLUSIONS	PFS and OS were higher in patients with p16-positive OPC , but outcomes did not differ by EGFR expression .

###24465542
BACKGROUND	Oncogenic mutations are powerful predictive biomarkers for molecularly targeted cancer therapies .
BACKGROUND	For mutation detection patients have to undergo invasive tumor biopsies .
BACKGROUND	Alternatively , archival samples are used which may no longer reflect the actual tumor status .
BACKGROUND	Circulating tumor cells ( CTC ) could serve as an alternative platform to detect somatic mutations in cancer patients .
BACKGROUND	We sought to develop a sensitive and specific assay to detect mutations in the EGFR gene in CTC from lung cancer patients .
METHODS	We developed a novel assay based on real-time polymerase chain reaction ( PCR ) and melting curve analysis to detect activating EGFR mutations in blood cell fractions enriched in CTC .
METHODS	Non-small-cell lung cancer ( NSCLC ) was chosen as disease model with reportedly very low CTC counts .
METHODS	The assay was prospectively validated in samples from patients with EGFR-mutant and EGFR-wild type NSCLC treated within a randomized clinical trial .
METHODS	Sequential analyses were conducted to monitor CTC signals during therapy and correlate mutation detection in CTC with treatment outcome .
RESULTS	Assay sensitivity was optimized to enable detection of a single EGFR-mutant CTC/mL peripheral blood .
RESULTS	CTC were detected in pretreatment blood samples from all 8 EGFR-mutant lung cancer patients studied .
RESULTS	Loss of EGFR-mutant CTC signals correlated with treatment response , and its reoccurrence preceded relapse .
CONCLUSIONS	Despite low abundance of CTC in NSCLC oncogenic mutations can be reproducibly detected by applying an unbiased CTC enrichment strategy and highly sensitive PCR and melting curve analysis .
CONCLUSIONS	This strategy may enable non-invasive , specific biomarker diagnostics and monitoring in patients undergoing targeted cancer therapies .

###25190661
OBJECTIVE	We defined the theoretical oxygen tension behind modern scleral contact lenses ( CLs ) made of different rigid gas permeable ( RGP ) materials , assuming different thickness of the tear layer behind the lens .
OBJECTIVE	A second goal was to show clinically the effect of the postlens tear film on corneal swelling .
METHODS	We simulated the partial pressure of oxygen across the cornea behind scleral CLs made of different lens materials ( oxygen permeability Dk , 75-200 barrer ) and different thickness ( Tav , 100-300 m ) .
METHODS	Postlens tear film thicknesses ( Tpost-tear ) ranging from 150 to 350 m were considered .
METHODS	Eight healthy subjects were fitted randomly with a scleral lens with a thin and a thick postlens tear layer in two different sessions for a period of 3 hours under open-eye conditions .
RESULTS	The CLs with less than 125 barrer of Dk and a thickness over 200 m depleted the oxygen availability at the lens-cornea interface below 55 mm Hg for a postlens tear film of 150 m. For a postlens tear film thickness of 350 m , no combination of material or lens thickness will meet the criteria of 55 mm Hg .
RESULTS	Our clinical measures of corneal edema showed that this was significantly higher ( P < 0.001 , Wilcoxon signed ranks test ) with the thicker compared to the thinner Tpost-tear ( mean SD , 1.66 1.12 vs. 4.27 1.19 % ) .
CONCLUSIONS	Scleral RGP CLs must be comprised of at least 125 barrer of oxygen permeability and up to 200 m thick to avoid hypoxic effects even under open eye conditions .
CONCLUSIONS	Postlens tear film layer should be below 150 m to avoid clinically significant edema .

###25541530
OBJECTIVE	To determine the influence of socio-demographic , clinical parameters and obstetric complications on postpartum health-related quality of life ( HRQoL ) .
METHODS	We used data of three randomized controlled trials to investigate HRQoL determinants in women after an obstetric complication .
METHODS	The DIGITAT and HYPITAT trials compared induction of labor and expectant management in women with intra-uterine growth restriction ( IUGR ) and hypertensive disorders .
METHODS	The WOMB trial randomized anemic women after postpartum hemorrhage to red blood cell transfusion or expectant management .
METHODS	The HRQoL-measure Short-Form36 was completed at six weeks postpartum .
METHODS	Multivariable analyses were used to identify which parameters affected the Short-Form36 physical component score ( PCS ) and mental component score ( MCS ) .
RESULTS	HRQoL analyses included 1391 women ( 60 % ) of the 2310 trial participants .
RESULTS	HYPITAT and DIGITAT participants had significantly lower MCS than WOMB participants .
RESULTS	In multivariable analysis , PCS after elective and emergency cesarean section was 5-6 points lower than after vaginal delivery .
RESULTS	Gestational hypertension , neonatal admission and delivery in an academic hospital had a small negative effect on PCS .
RESULTS	No effect was found for randomization status , maternal age , BMI , country of birth , education , parity , induction of labor , analgesics , birth weight , perineal laceration , delivery of placenta , postpartum hemorrhage , congenital anomaly , urinary tract infection , thromboembolic event or endometritis .
RESULTS	MCS was influenced only mildly by these parameters .
CONCLUSIONS	IUGR and hypertensive disorders lead to lower HRQoL scores postpartum than PPH .
CONCLUSIONS	In a heterogeneous obstetric population , only mode of delivery by cesarean section has a profound , negative impact , on physical HRQoL ( PCS ) .
CONCLUSIONS	No profound impacts on MCS were detected .

###24358287
OBJECTIVE	The effects of hypnosis on physiological ( gastrointestinal ) functions are incompletely understood , and it is unknown whether they are hypnosis-specific and gut-specific , or simply unspecific effects of relaxation .
METHODS	Sixty-two healthy female volunteers were randomly assigned to either a single session of hypnotic suggestion of ingesting an appetizing meal and an unappetizing meal , or to relax and concentrate on having an appetizing or unappetizing meal , while the electrogastrogram ( EGG ) was recorded .
METHODS	At the end of the session , participants drank water until they felt full , in order to detect EGG-signal changes after ingestion of a true gastric load .
METHODS	During both conditions participants reported their subjective well-being , hunger and disgust at several time points .
RESULTS	Imagining eating food induced subjective feelings of hunger and disgust as well as changes in the EGG similar to , but more pronounced than those seen with a real gastric water load during both hypnosis and relaxation conditions .
RESULTS	These effects were more pronounced when imagining an appetizing meal than with an unappetizing meal .
RESULTS	There was no significant difference between the hypnosis and relaxation conditions .
CONCLUSIONS	Imagination with and without hypnosis exhibits similar changes in subjective and objective measures in response to imagining an appetizing and an unappetizing food , indicating high sensitivity but low specificity .

###24284606
OBJECTIVE	To investigate the effects of two different rehabilitation programs in acute central vestibulopathy secondary to posterior circulation stroke .
METHODS	A prospective randomized controlled study was conducted on 25 patients with posterior circulation stroke .
METHODS	Patients were instructed in routine balance and mobility exercises during the acute hospitalization period .
METHODS	At discharge , patients were assigned to either a rehabilitation or home exercise group .
METHODS	The home exercise group was instructed to perform the same exercise program provided in the course of hospitalization period .
METHODS	The rehabilitation group was randomized into the visual feedback posturography training or vestibular rehabilitation group .
METHODS	The balance and gait performance were assessed with clinical and objective measurements before and after 6 weeks of training .
RESULTS	The balance and gait scores were significantly improved in both rehabilitation groups and in the home exercise group ( p < 0.05 ) , but no significant difference was found between the groups in terms of post-treatment values ( p > 0.05 ) .
CONCLUSIONS	The improvements of balance and gait function in rehabilitation groups did not differ from the home exercise group .
CONCLUSIONS	Rehabilitation programs were equally effective to improve the recovery in acute central vestibulopathy .

###24502856
OBJECTIVE	To compare the suitability of CO2 laser with steel instruments for margin excision in transoral laser microsurgery .
METHODS	Prospective randomized blinded study .
METHODS	Patients with glottic cancer undergoing laser resection were randomized to margin excision by either steel instruments or CO2 laser .
METHODS	Margins were analyzed for size , interpretability and degree of artifact by a pathologist who was blinded to technique .
RESULTS	45 patients were enrolled in the study with 226 total margins taken .
RESULTS	39 margins taken by laser had marked artifact and 0 were uninterpretable .
RESULTS	20 margins taken by steel instruments had marked artifact , and 2 were uninterpretable .
RESULTS	Controlling for margin size , the laser technique was associated with increasing degrees of margin artifact ( p = 0.210 ) , but there was no difference in crude rates of uninterpretability ( p = 0.24 ) .
CONCLUSIONS	Laser margin excision is associated with a greater degree of artifact than steel instrument excision , but was not associated with higher rate of uninterpretability .

###24360571
BACKGROUND	Less than half of patients with chronic hepatitis C genotype 3 ( G3 ) and high viral load ( HVL ) without a rapid virological response ( RVR ) achieve a sustained virological response ( SVR ) when treated with peginterferon plus ribavirin ( RBV ) .
OBJECTIVE	To assess the impact of high doses of RBV on SVR in patients with G3 and HVL .
METHODS	Ninety-seven patients were randomized to receive peginterferon -2 a + RBV 800 mg/day ( A ; n = 42 ) or peginterferon -2 a + RBV 1600 mg/day + epoetin 400 IU/kg/week SC ( B ; n = 55 ) .
METHODS	Patients allocated to group B who achieved RVR continued on RBV ( 800mg/day ) for a further 20 weeks ( B1 ; n = 42 ) while non-RVR patients received a higher dose of RBV ( 1600 mg/day ) + epoetin ( B2 ; n = 13 ) .
RESULTS	RVR was observed in 64.3 % of patients in A and in 76.4 % in B ( p = 0.259 ) .
RESULTS	Intention-to-treat ( ITT ) analysis showed SVR rates of 64.3 % ( A ) and 61.8 % ( B ) , with a reduction of -2.5 % ( -21.8 % to 16.9 % ) ( p = 0.835 ) .
RESULTS	The SVR rate was 61.9 % in arm B1 and 61.5 % in arm B2 .
RESULTS	No serious adverse events were reported , and the rate of moderate adverse events was < 5 % .
CONCLUSIONS	G3 patients with high viral load without RVR did not obtain a benefit from a higher dose of RBV .
CONCLUSIONS	Higher doses of RBV plus epoetin were safe and well tolerated ( Clin Trials Gov NCT00830609 ) .

###25527244
BACKGROUND	A limited number of nondigestible oligosaccharides are available for use in infant formula .
BACKGROUND	This study evaluated growth and safety in infants fed formula supplemented with a mixture of bovine milk-derived oligosaccharides ( BMOS ) .
BACKGROUND	This mixture , which was generated from whey permeate , contains galactooligosaccharides and other oligosaccharides from bovine milk , such as 3 ' - and 6 ' - sialyllactose .
BACKGROUND	We hypothesized that growth in infants fed BMOS-supplemented formula would be noninferior to that in infants fed standard formula .
METHODS	Healthy term infants 14days old were randomly assigned to standard formula ( control ; n = 84 ) ; standard formula with BMOS ( IF-BMOS ; n = 99 ) ; or standard formula with BMOS and probiotics ( Bifidobacterium longum , Lactobacillus rhamnosus ) ( IF-BMOS + Pro ; n = 98 ) .
METHODS	A breastfed reference group was also enrolled ( n = 30 ) .
METHODS	The primary outcome was mean weight gain/day from enrollment to age 4months ( noninferiority margin : -3.0 g/day ) .
RESULTS	189 ( 67.3 % ) formula-fed infants were included in the primary analysis .
RESULTS	Mean differences in weight gain between the control and IF-BMOS and IF-BMOS + Pro groups were < 1g/day , with 97.5 % confidence intervals above -3.0 g/day , indicating noninferior weight gain in the BMOS formula groups .
RESULTS	Compared with control , infants in the BMOS groups had more frequent ( p < 0.0001 ) and less hard ( p = 0.0003 ) stools .
RESULTS	No significant differences were observed between the control and BMOS groups in caregivers ' reports of flatulence , vomiting , spitting up , crying , fussing , and colic .
RESULTS	When based on clinical evaluation by the investigator , the incidence of colic was higher ( p = 0.01 ) in IF-BMOS than in control ; the incidence of investigator-diagnosed colic was not significantly different in control and IF-BMOS + Pro ( p = 0.15 ) .
RESULTS	Stool bifidobacteria and lactobacilli counts were higher with IF-BMOS + Pro compared with control ( p < 0.05 ) , whereas Clostridia counts were lower ( p < 0.05 ) in both BMOS groups compared with control .
CONCLUSIONS	Infant formula containing BMOS either with or without probiotics provides adequate nutrition for normal growth in healthy term infants .
CONCLUSIONS	Further studies are needed to fully explore the digestive tolerance of BMOS formula .
BACKGROUND	ClinicalTrials.gov NCT01886898 .
BACKGROUND	Registered 24 June 2013 .

###26004924
BACKGROUND	Frailty is a risk factor for adverse events after surgery .
BACKGROUND	Residents ' ability to recognize frailty is underdeveloped .
BACKGROUND	We assessed the influence of a frailty education module on surgical residents ' estimates of lobectomy risk .
METHODS	Traditional track cardiothoracic surgery residents were randomly allocated to take an online short course on frailty ( experimental group ) or to receive no training ( control group ) .
METHODS	Residents read a clinical vignette , made an initial risk estimate of major complications for lobectomy , and rated clinical factors on their importance to their estimates .
METHODS	They viewed a video of a standardized patient portraying the patient in the vignette , randomly selected to exhibit either vigorous or frail behavior , and provided a final risk estimate .
METHODS	After rating five vignettes , they completed a test on their frailty knowledge .
RESULTS	Forty-one residents participated ( 20 in the experimental group ) .
RESULTS	Initial risk estimates were similar between the groups .
RESULTS	The experimental group rated clinical factors as `` very important '' in their initial risk estimates more often than did the control group ( 47.6 % versus 38.5 % ; p < 0.001 ) .
RESULTS	Viewing videos resulted in a significant change from initial to final risk estimates ( frail 50 % 75 % increase , p = 0.008 ; vigorous 14 % 32 % decrease , p = 0.043 ) .
RESULTS	The magnitude of change in risk estimates was greater for the experimental group ( 10.0 8.1 versus 5.1 7.7 ; p < 0.001 ) .
RESULTS	The experimental group answered more frailty test questions correctly ( 93.7 % versus 75.2 % ; p < 0.001 ) .
CONCLUSIONS	A frailty education module improved resident knowledge of frailty and influenced surgical risk estimates .
CONCLUSIONS	Training in frailty may help educate residents in frailty recognition and surgical risk assessment .

###24997559
BACKGROUND	Type 1 diabetes results from autoimmune destruction of pancreatic cells .
BACKGROUND	Findings from preclinical studies suggest that dipeptidyl peptidase-4 inhibitors and proton-pump inhibitors might enhance - cell survival and regeneration .
BACKGROUND	We postulated that sitagliptin and lansoprazole would preserve - cell function in patients with recent-onset type 1 diabetes .
METHODS	We did a double-blind , placebo-controlled , phase 2 trial ( REPAIR-T1D ) .
METHODS	Participants aged 11-36 years , diagnosed with type 1 diabetes within the past 6 months were recruited from Sanford Health Systems ( Sioux Falls , SD , USA ; Fargo , ND , USA ) , Children 's Hospitals and Clinics of Minnesota ( St Paul , MN , USA ) , and Rady Children 's Hospital ( San Diego , CA , USA ) .
METHODS	Participants were randomly assigned ( 2:1 ) to receive oral sitagliptin ( 100 mg for participants 18 years , 50 mg for those < 18 years ) and lansoprazole ( 60 mg for participants 18 years , 30 mg for those < 18 years ) or matched placebo for 12 months .
METHODS	Randomisation was done by a blocked randomisation process ( blocks of three and six ) , with separate streams for younger ( < 18 years ) and older ( 18 years ) participants , and males and females .
METHODS	All participants and personnel remained masked until after the completion of the final 12 month visit , at which time data were unmasked to the analysis team .
METHODS	The primary endpoint was C-peptide response to a mixed meal challenge at 12 months measured as 2 h area under curve .
METHODS	Analysis was by intention to treat .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01155284 .
RESULTS	Between Sept 21 , 2010 , and May 29 , 2012 , 46 participants were randomly assigned to the treatment group and 22 to the placebo group ; of whom 40 participants in the treatment group and 18 in the placebo group completed the 12-month treatment .
RESULTS	At 12 months , the mean change in C-peptide area under curve was -229 pmol/L ( 95 % CI -316 to -142 ) for the treatment group and -253 pmol/L ( -383 to -123 ) for the placebo group ; this difference was not significant ( p = 077 ) .
RESULTS	No adverse or serious adverse events were probably or definitely related to the study treatment .
CONCLUSIONS	Although the expected change in the primary endpoint was not achieved , not all participants had increases in glucagon-like peptide-1 and gastrin concentrations that were expected with treatment .
CONCLUSIONS	Although participants did not have adverse events related to study drugs , the study is not powered to address safety definitively .
CONCLUSIONS	Further trials including these drugs might be warranted , but should be designed to ensure appropriate selection of participants and increases in these intermediary hormones .
BACKGROUND	Sanford Research and JDRF .

###24622429
BACKGROUND	In the TARGET I randomized controlled trial , the novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent FIREHAWK proved non-inferior to the everolimus-eluting stent in nine-month in-stent late loss in single de novo coronary lesions .
BACKGROUND	This study was aimed at evaluating clinical safety and effectiveness of FIREHAWK in a moderately complex population ( including patients with small vessels , long lesions and multi-vessels ) , and at validating the ability of the SYNTAX score ( SS ) to predict clinical outcomes in patients treated with this latest generation drug-eluting stent .
METHODS	TARGET II was a prospective , multicenter , single-arm study with primary outcome of 12-month target lesion failure ( TLF ) , including cardiac death , target vessel myocardial infarction ( TV-MI ) and ischemia-driven target lesion revascularization ( TLR ) .
METHODS	Stent thrombosis was defined according to the Academic Research Consortium ( ARC ) definition .
METHODS	Patients were grouped by tertiles of SS ( 6 , > 6 to 12 , and > 12 ) .
METHODS	All patients were exclusively treated with the FIREHAWK stent and were followed up at 1 , 6 , and 12 months , and annually thereafter up to five years .
RESULTS	A total of 730 patients were included in this registry study .
RESULTS	The 12-month incidence of TLF was 4.4 % and the incidence of TLF components were , cardiac death 0.5 % , TV-MI 3.2 % , and TLR 2.2 % .
RESULTS	One definite/probable stent thrombosis was observed at 12-month follow-up .
RESULTS	Mean SS was 10.876.87 .
RESULTS	Patients in the SS > 12 tertile had significantly higher TLF ( P = 0.02 ) and TLR ( P < 0.01 ) rates than those in lower SS groups .
RESULTS	In COX proportional-hazards regression analyses , TLF incidence was strongly related to lesion length ( long lesion vs. non-long lesion patients ; HR 3.416 , 95 % CI , 1.622-7 .195 ) , but unrelated to diabetic , small vessel , and multivessel subgroups .
CONCLUSIONS	The low TLF incidence in this study indicates that FIREHAWK is safe and effective in the treatment of moderately complex coronary disease .
CONCLUSIONS	SS is also able to predict adverse clinical outcomes in FIREHAWK treated patients .

###25008950
OBJECTIVE	To determine the efficacy of 4 g/day fish oil to lower triglycerides and impact lipoprotein particles , inflammation , insulin resistance , coagulation , and thrombosis .
METHODS	Participants ( n = 42 , age 14 2 years ) with hypertriglyceridemia and low-density lipoprotein ( LDL ) cholesterol < 160 mg/dL were enrolled in a randomized , double-blind , crossover trial comparing 4 g of fish oil daily with placebo .
METHODS	Treatment interval was 8 weeks with a 4-week washout .
METHODS	Lipid profile , lipoprotein particle distribution and size , glucose , insulin , high-sensitivity C-reactive protein , interleukin-6 , fibrinogen , plasminogen activator inhibitor-1 , and thrombin generation were measured .
RESULTS	Baseline lipid profile was total cholesterol 194 ( 5.4 ) mg/dL ( mean [ SE ] ) , triglycerides 272 ( 21 ) mg/dL , high-density lipoprotein cholesterol 39 ( 1 ) mg/dL , and LDL cholesterol 112 ( 3.7 ) mg/dl .
RESULTS	LDL particle number was 1614 ( 60 ) nmol/L , LDL size was 19.9 ( 1.4 ) nm , and large very low-density lipoprotein/chylomicron particle number was 9.6 ( 1.4 ) nmol/L .
RESULTS	Triglycerides decreased on fish oil treatment but the difference was not significant compared with placebo ( -52 16 mg/dL vs -16 16 mg/dL ) .
RESULTS	Large very low-density lipoprotein particle number was reduced ( -5.83 1.29 nmol/L vs -0.96 1.31 nmol/L ; P < .0001 ) .
RESULTS	There was no change in LDL particle number or size .
RESULTS	There was a trend towards a lower prothrombotic state ( lower fibrinogen and plasminogen activator inhibitor-1 ; .10 > P > .05 ) ; no other group differences were seen .
CONCLUSIONS	In children , fish oil ( 4 g/day ) lowers triglycerides slightly and may have an antithrombotic effect but has no effect on LDL particles .

###24510841
OBJECTIVE	Examine the effect of weekday exposure over 6 months to different lunch sizes on energy intake and body weight in a free-living sample of working adults .
METHODS	Adults ( n = 233 ) were randomly assigned to one of three lunch size groups ( 400 kcal , 800 kcal , and 1,600 kcal ) or to a no-free lunch control group for 6 months .
METHODS	Weight and energy intake were measured at baseline , and months 1 , 3 , and 6 .
RESULTS	Lunch energy was significantly higher in the 800 and 1,600 kcal groups compared with the 400 kcal group ( P < 0.0001 ) .
RESULTS	Total energy was significantly higher for the 1,600 kcal group compared with the 400 and 800 kcal groups ( P = 0.02 ) .
RESULTS	Body weight change at 6 months did not significantly differ at the 5 % level by experimental group ( 1,600 kcal group : +1.1 kg ( SD = 0.44 ) ; 800 kcal group : -0.1 kg ( SD = 0.42 ) ; 400 kcal group : -0.1 kg ( SD = 0.43 ) ; control group : 1.1 ( SD = 0.42 ) ; P = 0.07 ) .
RESULTS	Weight gain over time was significant in the 1,600 kcal box lunch group ( P < 0.05 ) .
CONCLUSIONS	Weekday exposure for 6 months to a 1,600 kcal lunch caused significant increases in total energy intake and weight gain .

###25411039
BACKGROUND	Environmental enteropathy ( EE ) is subclinical , diffuse villous atrophy characterized by T cell infiltration of the small intestinal mucosa associated with nutrient malabsorption and stunting .
BACKGROUND	EE is assessed by the lactulose : mannitol ( L : M ) test , whereby nonmetabolized sugars are ingested and quantified in the urine .
BACKGROUND	Multiple micronutrient ( MN ) deficiency morphologically mimics EE , and -3 ( n-3 ) polyunsaturated fatty acids reduce mucosal inflammation in Crohn disease .
OBJECTIVE	We tested the hypothesis that supplementary MNs , with or without fish oil ( FO ) , would improve L : M in rural Malawian children aged 1-3 y compared with a control ( C ) group receiving a placebo .
METHODS	The MNs and FO provided the Recommended Dietary Intake for 26 vitamins , minerals , eicosapentaenoic acid , and docosahexaenoic acid .
METHODS	This was a 3-arm , randomized , double-blind , placebo-controlled clinical trial , with the primary outcomes being the change in L : M ( L : M ) after 12 and 24 wk of supplementation .
METHODS	Comparisons were made for L : M after 12 and 24 wk within each group by using a Wilcoxon matched pairs signed rank test , because the data are not normally distributed .
RESULTS	A total of 230 children had specimens adequate for analysis ; all had an abnormal baseline L : M , defined as > 0.10 .
RESULTS	After 12 wk , children who received MNs + FO had a L : M [ mean ( 95 % CI ) ] of -0.10 ( -0.04 , -0.15 ; P = 0.001 ) , and children receiving only MNs had L : M of -0.12 ( -0.03 , -0.21 ; P = 0.002 ) .
RESULTS	After 24 wk , children who received MNs + FO had a L : M of -0.09 ( -0.03 , -0.15 ; P = 0.001 ) ; children receiving only MNs had a L : M of -0.11 ( -0.02 , -0.20 ; P = 0.001 ) , and the C group had L : M of -0.07 ( 0.02 , -0.16 ) ; P = 0.002 ) .
RESULTS	Linear growth was similar in all groups , 4.3 cm over 24 wk .
CONCLUSIONS	Although the effect was modest , these data suggest MNs can transiently ameliorate EE in rural African children .
CONCLUSIONS	The trial was registered at clinicaltrials.gov as NCT01593033 .

###25374219
OBJECTIVE	To investigate the impact of hyperglycemia during inductive treatment on the prognosis of acute lymphocytic leukemia ( ALL ) in children .
METHODS	Clinical data of 159 ALL childhood cases were reviewed .
METHODS	The patients were divided into the hyperglycemia group ( fasting glucose126 mg/dl and/or random blood glucose200 mg/dl ) and the euglycemia group according to the blood glucose values .
METHODS	The ?
METHODS	2 test was performed to compare the complete remission rates of the two groups , and Kaplan-Meier and log-rank tests were performed to compare the 5-year overall and relapse-free survival .
RESULTS	The incidence of hyperglycemia in the age10-year-old group was higher than the younger-age group ( P = 0.009 ) .
RESULTS	Values in the interim - and high-risk groups were higher than the standard-risk group ( P = 0.028 ) , while there was no significant difference between genders ( P = 0.056 ) .
RESULTS	The complete remission rates of the 2 groups demonstrated no significant difference ( P = 0.134 ) , while the 5-year OS of the hyperglycemia group was lower than in the euglycemia group ( 83.86.0 % vs 94.92.4 % , P = 0.014 ) .
RESULTS	The 5 - year RFS was significantly lower than the euglycemia group ( 62.98.7 % ) vs 80.29.1 % , P < 0.001 ) .
CONCLUSIONS	Children with age10 years old , and in the middle - and high-risk groups appear prone to complicating hyperglycemia during inductive chemotherapy , associated with lower 5-year OS and RFS .

###25465642
BACKGROUND	Breathlessness is a common and distressing symptom , which increases in many diseases as they progress and is difficult to manage .
BACKGROUND	We assessed the effectiveness of early palliative care integrated with respiratory services for patients with advanced disease and refractory breathlessness .
METHODS	In this single-blind randomised trial , we enrolled consecutive adults with refractory breathlessness and advanced disease from three large teaching hospitals and via general practitioners in South London .
METHODS	We randomly allocated ( 1:1 ) patients to receive either a breathlessness support service or usual care .
METHODS	Randomisation was computer generated centrally by the independent Clinical Trials Unit in a 1:1 ratio , by minimisation to balance four potential confounders : cancer versus non-cancer , breathlessness severity , presence of an informal caregiver , and ethnicity .
METHODS	The breathlessness support service was a short-term , single point of access service integrating palliative care , respiratory medicine , physiotherapy , and occupational therapy .
METHODS	Research interviewers were masked as to which patients were in the treatment group .
METHODS	Our primary outcome was patient-reported breathlessness mastery , a quality of life domain in the Chronic Respiratory Disease Questionnaire , at 6 weeks .
METHODS	All analyses were by intention to treat .
METHODS	Survival was a safety endpoint .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01165034 .
RESULTS	Between Oct 22 , 2010 and Sept 28 , 2012 , 105 consenting patients were randomly assigned ( 53 to breathlessness support service and 52 to usual care ) .
RESULTS	83 of 105 ( 78 % ) patients completed the assessment at week 6 .
RESULTS	Mastery in the breathlessness support service group improved compared with the control ( mean difference 058 , 95 % CI 001-115 , p = 0048 ; effect size 044 ) .
RESULTS	Sensitivity analysis found similar results .
RESULTS	Survival rate from randomisation to 6 months was better in the breathlessness support service group than in the control group ( 50 of 53 [ 94 % ] vs 39 of 52 [ 75 % ] ) and in overall survival ( generalised Wilcoxon 390 , p = 0048 ) .
RESULTS	Survival differences were significant for patients with chronic obstructive pulmonary disease and interstitial lung disease but not cancer .
CONCLUSIONS	The breathlessness support service improved breathlessness mastery .
CONCLUSIONS	Our findings provide robust evidence to support the early integration of palliative care for patients with diseases other than cancer and breathlessness as well as those with cancer .
CONCLUSIONS	The improvement in survival requires further investigation .
BACKGROUND	UK National Institute for Health Research ( NIHR ) and Cicely Saunders International .

###24862167
OBJECTIVE	To test the efficacy and safety of varenicline as an aid to smoking cessation in methadone-maintained smokers .
METHODS	Multicenter , randomized , double-blind , placebo-controlled trial with random assignment to 12 weeks of varenicline 1mg twice daily ( n = 57 ) or matched placebo ( n = 55 ) , with in-person and telephone counseling .
METHODS	Urban methadone programs in the Bronx , New York City , New York , USA .
METHODS	Methadone maintenance patients , smoking 5 cigarettes/day , interested in quitting , stable in methadone treatment , without current Axis I psychiatric disorders , suicidal ideation or recent suicide attempts .
METHODS	Seven-day point prevalence abstinence verified by expired carbon monoxide ( CO ) < 8 parts per million at week 12 ( primary outcome ) ; carbon monoxide ( CO ) - verified abstinence , cigarettes/day , incident Axis I psychiatric illness , suicidal ideation or serious adverse events ( SAEs ) at weeks 2 , 4 , 8 , 12 or 24 ( secondary outcomes ) .
RESULTS	Baseline demographic , smoking and clinical factors were similar between groups .
RESULTS	Retention at 24 weeks was 90 % .
RESULTS	Subjects receiving varenicline were more likely than those receiving placebo to achieve abstinence ( 10.5 versus 0 % , P = 0.03 ; effect size 10.5 % , 95 % confidence interval ( CI ) = 4.4-19 .3 % ) and to reduce smoking ( median five versus two cigarettes/day , P < 0.001 ) at 12 weeks .
RESULTS	These effects were not maintained after drug treatment ceased .
RESULTS	Incident psychiatric illness ( OR = 0.84 , 95 % CI = 0.16 , 4.4 ) and suicidality [ odds ratio ( OR ) = 0.88 , 95 % CI 0.2 , 3.9 ] were not different between groups .
RESULTS	There were no psychiatric or cardiac SAEs .
CONCLUSIONS	Varenicline can aid short-term smoking abstinence in methadone-maintained smokers .

###25325608
OBJECTIVE	To determine if weight loss and / or changes in apnea-hypopnea index ( AHI ) improve sleep architecture in overweight / obese adults with type 2 diabetes ( T2D ) and obstructive sleep apnea ( OSA ) .
METHODS	This was a randomized controlled trial including 264 overweight / obese adults with T2D and OSA .
METHODS	Participants were randomized to an intensive lifestyle intervention ( ILI ) or a diabetes and support education ( DSE ) control group .
METHODS	Measures included anthropometry , AHI , and sleep at baseline and year-1 , year-2 , and year-4 follow-ups .
RESULTS	Changes in sleep duration ( total sleep time [ TST ] ) , continuity [ wake after sleep onset ( WASO ) ] , and architecture stage 1 , stage 2 , slow wave sleep , and REM sleep ) from baseline to year 1 , 2 , and 4 did not differ between ILI and DSE .
RESULTS	Repeated-measure mixed-model analyses including data from baseline through year-4 for all participants demonstrated a significant positive association between AHI and stage 1 sleep ( p < 0.001 ) , and a significant negative association between AHI and stage 2 ( p = 0.01 ) and REM sleep ( p < 0.001 ) , whereas changes in body weight had no relation to any sleep stages or TST .
RESULTS	WASO had a significant positive association with change in body weight ( p = 0.009 ) .
CONCLUSIONS	Compared to control , the ILI did not induce significant changes in sleep across the 4-year follow-up .
CONCLUSIONS	In participants overall , reduced AHI in overweight / obese adults with T2D and OSA was associated with decreased stage 1 , and increased stage 2 and REM sleep .
CONCLUSIONS	These sleep architecture changes are more strongly related to reductions in AHI than body weight , whereas WASO may be more influenced by weight than AHI .
BACKGROUND	NCT00194259 .

###24504810
OBJECTIVE	To compare the efficacy and safety of intravenous ( IV ) abatacept , a selective T cell costimulation modulator , versus placebo for the treatment of active class III or IV lupus nephritis , when used on a background of mycophenolate mofetil and glucocorticoids .
METHODS	This was a 12-month , randomized , phase II/III , multicenter , international , double-blind study .
METHODS	A total of 298 patients were treated in 1 of 3 IV treatment arms : placebo , abatacept at the standard weight-tiered dose ( approximating 10 mg/kg ) , or abatacept at 30 mg/kg for 3 months , followed by the standard weight-tiered dose ( abatacept 30/10 ) .
METHODS	The primary end point , time to confirmed complete response , was a composite measure that required maintenance of glomerular filtration rate , minimal proteinuria , and inactive urinary sediment over the 52-week treatment period .
RESULTS	There were no differences among treatment arms in the time to confirmed complete response or in the proportion of subjects with confirmed complete response following 52 weeks of treatment .
RESULTS	Treatment with abatacept was associated with greater improvements from baseline in anti-double-stranded DNA antibody , C3 , and C4 levels .
RESULTS	Among 122 patients with nephrotic-range proteinuria , treatment with abatacept resulted in an 20-30 % greater reduction in mean urinary protein-to-creatinine ratio compared with placebo .
RESULTS	Abatacept was well tolerated ; rates of deaths , serious adverse events , and serious infections were similar across treatment arms .
RESULTS	Gastroenteritis and herpes zoster occurred more frequently with abatacept treatment .
CONCLUSIONS	Although the primary end point was not met , abatacept showed evidence of biologic activity and was well tolerated in patients with active class III or IV lupus nephritis .

###24296423
OBJECTIVE	The goals of this study were to investigate the role of a new probiotic preparation ( Lactobacillus reuteri DSM 17938 and L. reuteri ATCC PTA 6475 ) in Helicobacter pylori infection .
BACKGROUND	Specific probiotic strains play a role in H. pylori infection for their ability to decrease bacterial load and gastritis , prevent antibiotic-associated side effects , and increase the eradication rate .
METHODS	This is a prospective , double-blind , randomized , placebo-controlled study in a tertiary care setting .
METHODS	A total of 100 H. pylori-positive naive patients received either L. reuteri combination ( 210 Colony Forming Units ) or placebo during a 3-phase study ( pre-eradication , eradication , and follow-up ) .
METHODS	All underwent C urea breath test ( C-UBT ) , blood assessments of gastrin-17 ( G17 ) , endoscopy , and the Gastrointestinal Symptom Rating Scale .
METHODS	Eradication was confirmed by C-UBT 8 weeks after the completion of therapy .
RESULTS	Fifty patients were allocated in each group .
RESULTS	During pre-eradication period , C-UBT decreased by 13 % in L. reuteri combination as compared with a 4 % increase in placebo ( -13.234 % vs. 4.327 % ; P < 0.03 ) .
RESULTS	During eradication , GSRS increased significantly in placebo as compared with L. reuteri combination ( 6.82.9 vs. 43.1 ; P < 0.01 ) .
RESULTS	Significantly less patients in L. reuteri combination as compared with placebo-reported side effects ( 40.9 % vs. 62.8 % ; P < 0.04 ) .
RESULTS	An abnormal G17 value was found in patients receiving placebo as compared with L. reuteri combination ( 28 % vs. 12 % ; P < 0.02 ) .
RESULTS	Eradication rate was 75 % in L. reuteri combination and 65.9 % in placebo ( P = NS ) .
RESULTS	L. reuteri combination increased eradication rate by 9.1 % ( odds ratio : 1.5 ) .
CONCLUSIONS	L. reuteri combination alone is able to exert an inhibitory effect on H. pylori growth , and when administered with eradication therapy , it determines a significant reduction in antibiotic-associated side effects .
CONCLUSIONS	Moreover , L. reuteri combination was able to decrease serum G17 levels and to ( not significantly ) increase the H. pylori-eradication rate .

###26136593
BACKGROUND	The consumption of orange juice may lead to reduced oxidative stress and may enhance the antioxidant defense system .
OBJECTIVE	The aim was to evaluate the effects of the intake of orange juice containing either normal ( NPJ ) or high ( HPJ ) concentrations of polyphenols ( 299 and 745 mg/d , respectively ) on the antioxidant defense system , oxidative stress biomarkers , and clinical signs of metabolic syndrome in 100 nonsmoking subjects who were either overweight or obese .
METHODS	A randomized , double-blind crossover study was conducted over two 12-wk periods with a 7-wk washout period .
METHODS	The effects on enzymatic and nonenzymatic blood antioxidant defense systems , urinary and plasma oxidative stress biomarkers , and clinical signs of metabolic syndrome were evaluated before and after an intervention with both of the orange juices .
METHODS	Paired t tests and linear mixed-effects models were used to evaluate the effects of juice , time , and interactions .
RESULTS	The intake of either NPJ or HPJ led to a decrease in urinary 8-hydroxy-2 ' - deoxyguanosine ( NPJ : 935 134 to 298 19 ng/mg creatinine ; HPJ : 749 84 to 285 17 ng/mg creatinine ) , 8-iso-prostaglandin F2 ( NPJ : 437 68 to 156 14 ng/mg creatinine ; HPJ : 347 43 to 154 13 ng/mg creatinine ) , erythrocyte catalase , and glutathione reductase activities .
RESULTS	A decrease was also observed in body mass index , waist circumference , and leptin ( all P < 0.05 ) .
RESULTS	The NPJ intervention decreased systolic and diastolic blood pressures ( systolic blood pressure : 128 1 to 124 2 mm Hg ; diastolic blood pressure : 79 1 to 76 1 mm Hg ) , whereas the HPJ intervention increased erythrocyte superoxide dismutase ( SOD ) activity ( 17.7 1.5 to 23.1 1.7 U/mg hemoglobin ) .
CONCLUSIONS	Our results show that the consumption of either NPJ or HPJ protected against DNA damage and lipid peroxidation , modified several antioxidant enzymes , and reduced body weight in overweight or obese nonsmoking adults .
CONCLUSIONS	Only blood pressure and SOD activity were influenced differently by the different flavanone supplementations .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01290250 .

###24685389
OBJECTIVE	To determine the effects of using a continuous passive motion ( CPM ) device for individuals with poor range of motion ( ROM ) after a total knee replacement ( TKR ) admitted for postacute rehabilitation .
METHODS	Randomized controlled trial .
METHODS	Inpatient rehabilitation facility ( IRF ) .
METHODS	Adults ( N = 141 ) after TKR with initial active knee flexion < 75 on admission to the IRF .
METHODS	Two randomized groups : group 1 ( n = 71 ) received the conventional 3 hours of therapy per day , and group 2 ( n = 70 ) received the addition of daily CPM use for 2 hours throughout their length of stay .
METHODS	The primary outcome measure was active knee flexion ROM .
METHODS	Secondary outcome measures included active knee extension ROM length of stay , estimate of function using the FIM and Timed Up and Go test , girth measurement , and self-reported Western Ontario and McMaster Universities Osteoarthritis Index scores .
RESULTS	All subjects significantly improved from admission to discharge in all outcome measures .
RESULTS	However , there were no statistically significant differences in any of the discharge outcome measures of the CPM group compared with the non-CPM group .
CONCLUSIONS	CPM does not provide an additional benefit over the conventional interventions used in an IRF for patient after TKR , specifically in patients with poor initial knee flexion ROM after surgery .

###24939676
OBJECTIVE	The aim of this study was to investigate the influence of the pharmacokinetics of s.c. anti-TNF agents on the grade of US-detected synovitis in RA patients .
METHODS	Fifty RA patients were prospectively recruited from the Biologic Therapy Unit of our hospital .
METHODS	Inclusion criteria were being in treatment with s.c. anti-TNF agents and having had neither changes in therapy nor local corticosteroid injections in the previous 3 months .
METHODS	Patients underwent clinical , laboratory [ 28-joint DAS ( DAS28 ) and Simplified Disease Activity Index ( SDAI ) ] and US assessment at two time points , i.e. at peak plasma drug concentration and at trough plasma drug concentration .
METHODS	US assessments were performed blindly to the anti-TNF agent , the administration time and the clinical and laboratory data .
METHODS	Twenty-eight joints were investigated for the presence and grade ( 0-3 ) of B-mode synovitis and synovial power Doppler signal .
METHODS	Global indices for B-mode synovitis ( BSI ) and Doppler synovitis ( DSI ) were calculated for 12 joints and for wrist-hand-ankle-foot joints .
METHODS	B-mode US remission was defined as a BSI < 1 and Doppler US remission as a DSI < 1 .
RESULTS	There were no significant differences between the clinical , laboratory and B-mode and Doppler US parameters at peak time and trough time ( P = 0.132-0 .986 ) .
RESULTS	There were no significant differences between the proportion of patients with active disease and those in remission according to DAS28 , SDAI , B-mode US and Doppler US at peak time and trough time assessments ( P = 0.070-1 ) .
CONCLUSIONS	Our results suggested that s.c. anti-TNF pharmacokinetics do not significantly influence US-scored synovitis in RA patients .

###24336948
BACKGROUND	In the Third International Study on Syncope of Uncertain Etiology ( ISSUE-3 ) , cardiac pacing was effective in reducing recurrence of syncope in patients with presumed neurally mediated syncope ( NMS ) and documented asystole but syncope still recurred in 25 % of them at 2 years .
BACKGROUND	We have investigated the role of tilt testing ( TT ) in predicting recurrences .
RESULTS	In 136 patients enrolled in the ISSUE-3 , TT was positive in 76 and negative in 60 .
RESULTS	An asystolic response predicted a similar asystolic form during implantable loop recorder monitoring , with a positive predictive value of 86 % .
RESULTS	The corresponding values were 48 % in patients with non-asystolic TT and 58 % in patients with negative TT ( P = 0.001 versus asystolic TT ) .
RESULTS	Fifty-two patients ( 26 TT + and 26 TT - ) with asystolic neurally mediated syncope received a pacemaker .
RESULTS	Syncope recurred in 8 TT + and in 1 TT - patients .
RESULTS	At 21 months , the estimated product-limit syncope recurrence rates were 55 % and 5 % , respectively ( P = 0.004 ) .
RESULTS	The TT + recurrence rate was similar to that seen in 45 untreated patients ( control group ) , which was 64 % ( P = 0.75 ) .
RESULTS	The recurrence rate was similar between 14 patients with asystolic and 12 with non-asystolic responses during TT ( P = 0.53 ) .
CONCLUSIONS	Cardiac pacing was effective in neurally mediated syncope patients with documented asystolic episodes in whom TT was negative ; conversely , there was insufficient evidence of efficacy from this data set in patients with a positive TT even when spontaneous asystole was documented .
CONCLUSIONS	Present observations are unexpected and need to be confirmed by other studies .
CONCLUSIONS	Clinical Trial Registration - URL : http://www.clinicaltrials.gov .
CONCLUSIONS	Unique identifier : NCT01463358 .

###24533792
BACKGROUND	Irrational prescribing of over-the-counter ( OTC ) medicines in general practice is common in Southern Europe .
BACKGROUND	Recent findings from a research project funded by the European Commission ( FP7 ) , the `` OTC SOCIOMED '' , conducted in seven European countries , indicate that physicians in countries in the Mediterranean Europe region prescribe medicines to a higher degree in comparison to physicians in other participating European countries .
BACKGROUND	In light of these findings , a feasibility study has been designed to explore the acceptance of a pilot educational intervention targeting physicians in general practice in various settings in the Mediterranean Europe region .
METHODS	This feasibility study utilized an educational intervention was designed using the Theory of Planned Behaviour ( TPB ) .
METHODS	It took place in geographically-defined primary care areas in Cyprus , France , Greece , Malta , and Turkey .
METHODS	General Practitioners ( GPs ) were recruited in each country and randomly assigned into two study groups in each of the participating countries .
METHODS	The intervention included a one-day intensive training programme , a poster presentation , and regular visits of trained professionals to the workplaces of participants .
METHODS	Reminder messages and email messages were , also , sent to participants over a 4-week period .
METHODS	A pre - and post-test evaluation study design with quantitative and qualitative data was employed .
METHODS	The primary outcome of this feasibility pilot intervention was to reduce GPs ' intention to provide medicines following the educational intervention , and its secondary outcomes included a reduction of prescribed medicines following the intervention , as well as an assessment of its practicality and acceptance by the participating GPs .
RESULTS	Median intention scores in the intervention groups were reduced , following the educational intervention , in comparison to the control group .
RESULTS	Descriptive analysis of related questions indicated a high overall acceptance and perceived practicality of the intervention programme by GPs , with median scores above 5 on a 7-point Likert scale .
CONCLUSIONS	Evidence from this intervention will estimate the parameters required to design a larger study aimed at assessing the effectiveness of such educational interventions .
CONCLUSIONS	In addition , it could also help inform health policy makers and decision makers regarding the management of behavioural changes in the prescribing patterns of physicians in Mediterranean Europe , particularly in Southern European countries .

###26104940
OBJECTIVE	The purpose of this study was to establish reproducible guidelines for delineating the clinical target volume ( CTV ) of the pelvic lymph nodes ( LN ) by combining the freehand Royal Marsden Hospital ( RMH ) and Radiation Therapy Oncology Group ( RTOG ) vascular expansion techniques .
METHODS	Seven patients with prostate cancer underwent standard planning computed tomography scanning .
METHODS	Four different CTVs ( RMH , RTOG , modified RTOG , and Prostate and pelvIs Versus prOsTate Alone treatment for Locally advanced prostate cancer [ PIVOTAL ] trial ) were created for each patient , and 6 different bowel expansion margins ( BEM ) were created to assess bowel avoidance by the CTV .
METHODS	The resulting CTVs were compared visually and by using Jaccard conformity indices .
METHODS	The volume of overlap between bowel and planning target volume ( PTV ) was measured to aid selection of an appropriate BEM to enable maximal LN yet minimal normal tissue coverage .
RESULTS	In total , 84 nodal contours were evaluated .
RESULTS	LN coverage was similar in all groups , with all of the vascular-expansion techniques ( RTOG , modified RTOG , and PIVOTAL ) , resulting in larger CTVs than that of the RMH technique ( mean volumes : 287.3 cm ( 3 ) , 326.7 cm ( 3 ) , 310.3 cm ( 3 ) , and 256.7 cm ( 3 ) , respectively ) .
RESULTS	Mean volumes of bowel within the modified RTOG PTV were 19.5 cm ( 3 ) ( with 0 mm BEM ) , 17.4 cm ( 3 ) ( 1-mm BEM ) , 10.8 cm ( 3 ) ( 2-mm BEM ) , 6.9 cm ( 3 ) ( 3-mm BEM ) , 5.0 cm ( 3 ) ( 4-mm BEM ) , and 1.4 cm ( 3 ) ( 5-mm BEM ) in comparison with an overlap of 9.2 cm ( 3 ) seen using the RMH technique .
RESULTS	Evaluation of conformity between LN-CTVs from each technique revealed similar volumes and coverage .
CONCLUSIONS	Vascular expansion techniques result in larger LN-CTVs than the freehand RMH technique .
CONCLUSIONS	Because the RMH technique is supported by phase 1 and 2 trial safety data , we proposed modifications to the RTOG technique , including the addition of a 3-mm BEM , which resulted in LN-CTV coverage similar to that of the RMH technique , with reduction in bowel and planning target volume overlap .
CONCLUSIONS	On the basis of these findings , recommended guidelines including a detailed pelvic LN contouring atlas have been produced and implemented in the PIVOTAL trial .

###24262818
BACKGROUND	Depression is expensive to treat , but providing ineffective treatment is more expensive .
BACKGROUND	Such is the case for many patients who do not respond to antidepressant medication .
OBJECTIVE	To assess the cost-effectiveness of cognitive-behavioural therapy ( CBT ) plus usual care for primary care patients with treatment-resistant depression compared with usual care alone .
METHODS	Economic evaluation at 12 months alongside a randomised controlled trial .
METHODS	Cost-effectiveness assessed using a cost-consequences framework comparing cost to the health and social care provider , patients and society , with a range of outcomes .
METHODS	Cost-utility analysis comparing health and social care costs with quality-adjusted life-years ( QALYs ) .
RESULTS	The mean cost of CBT per participant was 910 .
RESULTS	The difference in QALY gain between the groups was 0.057 , equivalent to 21 days a year of good health .
RESULTS	The incremental cost-effectiveness ratio was 14 911 ( representing a 74 % probability of the intervention being cost-effective at the National Institute of Health and Care Excellence threshold of 20 000 per QALY ) .
RESULTS	Loss of earnings and productivity costs were substantial but there was no evidence of a difference between intervention and control groups .
CONCLUSIONS	The addition of CBT to usual care is cost-effective in patients who have not responded to antidepressants .
CONCLUSIONS	Primary care physicians should therefore be encouraged to refer such individuals for CBT .

###25100550
BACKGROUND	The increasing prevalence and associated cost of treating chronic obstructive pulmonary disease ( COPD ) is unsustainable , and focus is needed on self-management and prevention of hospital admissions .
BACKGROUND	Telehealth monitoring of patients ' vital signs allows clinicians to prioritise their workload and enables patients to take more responsibility for their health .
BACKGROUND	This paper reports the results of a pilot randomised controlled trial ( RCT ) of Telehealth-supported care within a community-based COPD supported-discharge service .
METHODS	A two-arm pragmatic pilot RCT was conducted comparing the standard service with a Telehealth-supported service and assessed the potential for progressing into a full RCT .
METHODS	The co-primary outcome measures were the proportion of COPD patients readmitted to hospital and changes in patients ' self-reported quality of life .
METHODS	The objectives were to assess the suitability of the methodology , produce a sample size calculation for a full RCT , and to give an indication of cost-effectiveness for both pathways .
RESULTS	Sixty three participants were recruited ( n = 31 Standard ; n = 32 Telehealth ) ; 15 participants were excluded from analysis due to inadequate data completion or withdrawal from the Telehealth arm .
RESULTS	Recruitment was slow with significant gaps in data collection , due predominantly to an unanticipated 60 % reduction of staff capacity within the clinical team .
RESULTS	The sample size calculation was guided by estimates of clinically important effects and COPD readmission rates derived from the literature .
RESULTS	Descriptive analyses showed that the standard service group had a lower proportion of patients with hospital readmissions and a greater increase in self-reported quality of life compared to the Telehealth-supported group .
RESULTS	Telehealth was cost-effective only if hospital admissions data were excluded .
CONCLUSIONS	Slow recruitment rates and service reconfigurations prevented progression to a full RCT .
CONCLUSIONS	Although there are advantages to conducting an RCT with data collection conducted by a frontline clinical team , in this case , challenges arose when resources within the team were reduced by external events .
CONCLUSIONS	Gaps in data collection were resolved by recruiting a research nurse .
CONCLUSIONS	This study reinforces previous findings regarding the difficulty of undertaking evaluation of complex interventions , and provides recommendations for the introduction and evaluation of complex interventions within clinical settings , such as prioritisation of research within the clinical remit .
BACKGROUND	Current Controlled Trials ISRCTN68856013 , registered Nov 2010 .

###24719911
OBJECTIVE	The basal insulin analogue LY2605541 , a PEGylated insulin lispro with prolonged duration of action , was previously shown to be associated with modest weight loss in Phase 2 , randomized , open-label trials in type 2 ( N = 288 ) and type 1 ( N = 137 ) diabetes mellitus ( T2DM and T1DM ) , compared with modest weight gain with insulin glargine .
OBJECTIVE	Exploratory analyses were conducted to further characterize these findings .
METHODS	Pearson correlations between change in body weight and other variables were calculated .
METHODS	Continuous variables were analysed using a mixed linear model with repeated measurements .
METHODS	Proportions of subjects with weight loss were analysed using Fisher 's exact test for T2DM and Nagelkerke 's method for T1DM .
RESULTS	Weight loss was more common in LY2605541-treated patients than in patients treated with insulin glargine ( T2DM : 56.9 vs. 40.2 % , p = 0.011 ; T1DM : 66.1 vs. 40.3 % , p < 0.001 ) .
RESULTS	More LY2605541-treated patients experienced 5 % weight loss compared to patients treated with glargine ( T2DM : 4.8 vs. 0 % , p = 0.033 ; T1DM : 11.9 vs. 0.8 % , p < 0.001 ) .
RESULTS	In both the T1DM and T2DM studies , weight change did not correlate with baseline body mass index ( BMI ) , or change in HDL-cholesterol in either treatment group .
RESULTS	No consistent correlations were found across both studies between weight change and any of the variables assessed ; however , weight change was significantly correlated with hypoglycaemia rate in glargine-treated T2DM patients .
CONCLUSIONS	In two Phase 2 trials , improved glycaemic control with long-acting basal insulin analogue LY2605541 is associated with weight loss in previously insulin-treated patients .
CONCLUSIONS	This weight change is independent of baseline BMI or hypoglycaemia .

###25203806
OBJECTIVE	Endogenous hydrophobic bile acids may be a pathogenetic factor of biliary complications after orthotopic liver transplantation ( OLT ) .
OBJECTIVE	This study was designed to investigate the effects of hydrophilic ursodeoxycholic acid ( UDCA ) , when administered early after OLT , on serum liver tests and on the incidence of biliary complications .
METHODS	A total of 112 adult patients undergoing OLT were randomly assigned to one of two groups for receipt of UDCA ( 13 to 15 mg/kg/d for 4 weeks , n = 56 ) or a placebo ( n = 56 ) .
METHODS	All patients underwent serum liver testing and measurement of serum bile acids during the 4 weeks following OLT.Patients with T-tube underwent measurement of biliary bile acids during the 4 weeks following OLT.Biliary complications , as well as patient and graft survival rates , were analyzed during the follow-up period ( mean of 65.6 months ) .
RESULTS	At post-OLT days 7 , 21 and 28 , the UDCA-treated patients showed significantly lower levels of alanine aminotransferase , aspartate aminotransferase and gamma glutamyl transpeptidase ( all P less than 0.05 ) .
RESULTS	In addition , the UDCA-treated patients showed significantly lower incidence of biliary sludge and casts within the first year post-OLT ( 3.6 % vs. 14.3 % ; x2 = 3.953 , P = 0.047 ) .
RESULTS	However , there were no significant differences for the incidence of other biliary complications at post-OLT years 1 , 3 and 5 .
RESULTS	The graft and patient survival rates were also similar between the two groups .
CONCLUSIONS	UDCA , when administered early after OLT , improves results from serum liver tests and decreases the incidence of biliary sludge and casts within the first postoperative year .

###26169611
OBJECTIVE	Tivantinib , a MET receptor tyrosine kinase inhibitor , demonstrated increased anticancer activity in preclinical and early clinical studies when combined with erlotinib .
OBJECTIVE	Our study aimed to confirm efficacy and safety of the combination in previously treated patients with non-small-cell lung cancer ( NSCLC ) .
METHODS	Patients with advanced nonsquamous NSCLC previously treated with one to two systemic regimens , including a platinum doublet , were randomly assigned at a 1:1 ratio to receive erlotinib 150 mg daily plus oral tivantinib 360 mg twice daily ( E + T ) or erlotinib plus placebo ( E + P ) until disease progression .
METHODS	Tumor specimens were evaluated for EGFR and KRAS mutations , MET expression , and MET gene amplification .
METHODS	The primary end point was overall survival ( OS ) .
METHODS	Secondary and exploratory objectives included progression-free survival ( PFS ) , OS in molecular subgroups , and safety .
RESULTS	The study enrolled 1,048 patients and was discontinued for futility at the interim analysis .
RESULTS	OS did not improve with E + T versus E + P ( median OS , 8.5 v 7.8 months , respectively ; hazard ratio [ HR ] , 0.98 ; 95 % CI , 0.84 to 1.15 ; P = .81 ) , even though PFS increased ( median PFS , 3.6 v 1.9 months ; HR , 0.74 ; 95 % CI , 0.62 to 0.89 ; P < .001 ) .
RESULTS	Exploratory subgroup analyses suggested OS improvement in patients with high MET expression ( HR , 0.70 ; 95 % CI , 0.49 to 1.01 ) .
RESULTS	Most common adverse events occurring with E + T versus E + P were rash ( 33.1 % v 37.3 % , respectively ) , diarrhea ( 34.6 % v 41.0 % ) , asthenia or fatigue ( 43.5 % v 38.1 % ) , and neutropenia ( grade 3 to 4 ; 8.5 % v 0.8 % ) .
CONCLUSIONS	E + T was well tolerated and increased PFS but did not improve OS in the overall nonsquamous NSCLC population .

###24252934
OBJECTIVE	The aim of the current study was to examine the effect of body weight support treadmill training ( BWSTT ) with power-assisted functional electrical stimulation on functional movement and gait in stroke patients .
METHODS	Thirty stroke patients were randomly assigned to either the experimental group ( n = 15 ) or the control group ( n = 15 ) .
METHODS	All subjects participated in the same standard rehabilitation program .
METHODS	In addition , the experimental group participated in BWSTT with power-assisted functional electrical stimulation for 30 mins per day , five times a week , for 4 wks , and those in the control group participated in BWSTT for 30 minutes per day , five times a week , for 4 wks .
METHODS	Functional movement was assessed using the Berg Balance Scale , the Timed Up and Go test , and the Stroke Rehabilitation Assessment of Movement .
METHODS	Gait ability was assessed using an electrical walkway system .
RESULTS	Significant differences in the time factor for functional movement and gait ( P < 0.05 ) were observed in the experimental and control groups .
RESULTS	For the group time interaction , significant improvements were observed in the functional movement ( Berg Balance Scale [ 10.93 vs. 6.00 ] , Timed Up and Go test [ -9.25 vs. -5.25 secs ] , and Stroke Rehabilitation Assessment of Movement scores [ 14.07 vs. 9.80 ] ) and gait ( velocity [ 40.07 vs. 18.64 cm/sec ] , cadence [ 30.57 vs. 17.75 steps per minute ] , paretic side step length [ 19.36 vs. 8.46 cm ] , and stride length [ 30.57 vs. 12.71 cm ] ) ( P < 0.05 ) .
CONCLUSIONS	The findings of the current study demonstrated the efficacy of BWSTT with power-assisted functional electrical stimulation on the functional movement and gait ability in stroke patients .
CONCLUSIONS	Therefore , the authors suggest that power-assisted functional electrical stimulation may be an effective method for the improvement of functional movement and gait ability of stroke patients when added to BWSTT .

###25041550
OBJECTIVE	To determine the influence of non-surgical mechanical periodontal treatment on inflammatory markers related to risk for cardiovascular disease .
METHODS	A total of 64 patients with severe chronic periodontitis was randomly subjected to immediately periodontal treatment ( test group , n = 32 ) or delayed periodontal treatment , without treatment during the study period ( control group , n = 32 ) .
METHODS	Clinical periodontal and laboratory examinations were performed at baseline ( T0 ) , 2months ( T2 ) , and 6months ( T6 ) after the initial examinations ( Control group ) or completion of periodontal treatment ( Test group ) .
RESULTS	After 2months of periodontal treatment there was a significant reduction of erythrocyte sedimentation rate ( ESR ) and triglycerides ( p = 0.002 , p = 0.004 , respectively ) in the test group .
RESULTS	Median values of C-reactive protein , ESR , total cholesterol , and triglycerides were reduced after 6month of periodontal treatment in the test group ( p < 0.001 , p < 0.001 , p < 0.001 , and p = 0.015 , respectively ) .
CONCLUSIONS	The non-surgical periodontal treatment was effective in reducing the levels of systemic inflammation markers and improved the lipid profile in subjects with severe chronic periodontitis .

###24815121
BACKGROUND	Organ shortage limits the application of organ transplantation .
BACKGROUND	The attitudes of intensive care unit ( ICU ) staff play an important role in organ advocating .
BACKGROUND	The effects of an education program for ICU nurses on organ advocating were uncertain .
BACKGROUND	The purpose of this study was to explore the effects of an education program based on the Theory of Planned Behavior ( TPB ) on ICU nurses ' attitudes and behavioral intentions to advocate deceased organ donation .
METHODS	Participants were recruited from 3 different ICU units in medical centers and were randomly assigned to either an experimental group ( n = 61 ) or a control group ( n = 62 ) .
METHODS	The nurses in the experimental group received comprehensive education programs , and the control groups received a brochure only .
METHODS	The outcome parameters were measured by questionnaires at 3 different time points of pretest , posttests immediately after education , and 2 months later .
RESULTS	Before education , there was no difference in attitude and behavior intentions between the control and experimental groups .
RESULTS	After TPB training , the nurses significantly changed their attitudes and behavior intentions on organ advocating , both immediately ( P < .01 ) and 2 months after the education program ( P < .01 ) .
RESULTS	In addition , multivariate analysis indicated that TPB training is significantly associated with the change of attitude ( P < .01 ) and behavior intention ( P < .05 ) of organ donation advocacy .
CONCLUSIONS	TPB education programs enhanced the ICU nurses ' attitudes and behavioral intentions on advocating organ donation .
CONCLUSIONS	Repeated education is advised to increase the participation of ICU nurses on organ advocacy .

###24580014
OBJECTIVE	To prospectively evaluate ovariectomy and ovariohysterectomy via midline coeliotomy when being employed by supervised final year veterinary students for the purpose of routine canine neutering .
METHODS	One hundred and eight female dogs of various breeds , presented to a veterinary teaching hospital for neutering , were randomly allocated to one of two surgery groups , ovariectomy or ovariohysterectomy .
METHODS	The specified procedure was performed by a supervised final year veterinary student .
METHODS	If the duration of surgery exceeded 2hours or if major surgical or anaesthetic complications occurred , the supervising surgeon intervened to complete the procedure .
RESULTS	Data analysed included age , weight , time from first incision to start of closure , duration of closure , total surgical time and length of incision .
RESULTS	Fifty-four dogs underwent each procedure .
RESULTS	There was no significant difference between the two surgery groups for any of the measured variables .
CONCLUSIONS	Ovariectomy is not associated with shorter surgical times or smaller abdominal incisions than ovariohysterectomy when employed by inexperienced surgeons .
CONCLUSIONS	As no major complications novel to ovariectomy occurred in this cohort of dogs , this study adds support to the existing literature indicating that ovariectomy is an acceptable alternative to ovariohysterectomy for canine neutering .

###25023791
BACKGROUND	We previously showed that intramyocardial bone marrow cell ( BMC ) injection in patients with refractory angina and chronic myocardial ischemia improves myocardial perfusion , cardiac function and disease-related complaints .
BACKGROUND	Treatment effect varied between patients , but the predictors of response remain to be identified .
BACKGROUND	Therefore , the aim of the present study was to assess whether patient characteristics , procedural data and baseline measurements influence the response to intramyocardial BMC treatment in a large cohort of refractory angina patients .
RESULTS	In 120 patients ( 64 9 years , 88 % men ) with refractory angina , 97 13 10 ( 6 ) BMCs were injected intramyocardially in regions with stress-inducible ischemia as assessed by single photon emission computed tomography ( SPECT ) .
RESULTS	Canadian Cardiovascular Society angina ( CCS ) class , quality-of-life score , exercise testing , SPECT and magnetic resonance imaging were performed at baseline and at 3 months follow-up demonstrating significant improvements in CCS class , quality-of-life , exercise capacity , myocardial perfusion and left ventricular function ( all variables P < 0.001 ) .
RESULTS	Multivariate analysis was performed to evaluate the influence of patient characteristics , procedural data and baseline measurements on BMC treatment response .
RESULTS	Based on the improvement of myocardial perfusion at stress , diabetes and a large number of ischemic segments at baseline were shown to be independently associated with a large response to BMC therapy .
CONCLUSIONS	The present study demonstrates that diabetes and a large number of ischemic segments are predictors of a large response to intramyocardial BMC injection in refractory angina and chronic ischemia .
CONCLUSIONS	Furthermore , the safety and efficacy results of previous trials are now confirmed in a larger study population .

###24529061
BACKGROUND	We investigated the relationship between hypoxia , human papillomavirus ( HPV ) status and outcome in head and neck squamous cell carcinoma .
METHODS	Patients with stage III and IV head and neck squamous cell carcinoma treated on phase I and II chemoradiation trials with 70-Gy radiation combined with tirapazamine/cisplatin or cisplatin/fluorouracil ( 5FU ) , hypoxic imaging using [ 18F ] - misonidazole positron emission tomography and known HPV status ( by p16 immunohistochemistry ) were included in this sub-study .
METHODS	Separate analyses were conducted to consider the impact of tirapazamine on HPV-negative tumours in the phase II trial .
RESULTS	Both p16-positive oropharyngeal tumours and p16-negative head and neck squamous cell carcinoma tumours had a high prevalence of tumour hypoxia ; 14/19 ( 74 % ) and 35/44 ( 80 % ) , respectively .
RESULTS	The distribution of hypoxia ( primary , nodal ) was similar .
RESULTS	On phase II , trial patients with p16-negative hypoxic tumours had worse loco-regional control with cisplatin and 5FU compared with tirapazamine and cisplatin ( P < 0.001 ) and worse failure-free survival ( hazard ratio = 5.18 ; 95 % confidence interval , 1.98-13 .55 ; P = 0.001 ) .
RESULTS	Only 1 out of 14 p16-positive patients on the phase II trial experienced loco-regional failure .
CONCLUSIONS	Hypoxia , as assessed by [ 18F ] - misonidazole positron emission tomography , is frequently present in both p16-positive and negative head and neck cancer .
CONCLUSIONS	Further research is required to determine whether hypoxic imaging can be used to predict benefit from hypoxia-targeting therapies in patients with p16-negative tumours .

###24646336
OBJECTIVE	To observe the progression of labor when oxytocin use is limited to the onset of the active stage of labor .
METHODS	A randomized , prospective controlled study was performed to address the issue of oxytocin infusion after the onset of active labor in 140 patients .
METHODS	In the study group , infusion of oxytocin was discontinued at the onset of the active phase of labor , which was accepted as a cervical dilatation of 5 cm .
METHODS	In the control group , incremental oxytocin infusion was administered until 5 cm cervical dilatation , and then was maintained at the same level until delivery .
RESULTS	The primary outcome variable was duration from the beginning of the active phase to delivery .
RESULTS	In the study group , the duration of the active phase of labor was about 30 min longer than in the control group and this difference was significant .
RESULTS	The secondary outcomes of the study were maternal-fetal complications of oxytocin and in both groups there were no significant differences .
CONCLUSIONS	It is not reasonable to discontinue oxytocin infusion at the beginning of active labor .
CONCLUSIONS	Nevertheless , for an accurate conclusion expanded investigations are needed .

###25962930
OBJECTIVE	To evaluate intestinal barrier function in neonates undergoing cardiac surgery using lactulose/mannitol ( L/M ) ratio measurements , and to determine correlations with early breast milk feeding .
METHODS	This was a single-center , prospective , randomized pilot study of 27 term-born neonates ( 37 weeks gestation ) requiring cardiac surgery who were randomized to 1 of 2 preoperative feeding groups : nil per os ( NPO ) or trophic ( 10 mL/kg/day ) breast milk feeds .
METHODS	At 3 time points ( preoperative [ preop ] , postoperative [ postop ] day 7 , and postop day 14 ) , subjects were administered an oral L/M solution , after which urine L/M ratios were measured using gas chromatography , with higher ratios indicative of increased intestinal permeability .
METHODS	Trends over time in the mean urine L/M ratios for each group were estimated using a general linear mixed model .
RESULTS	There were no adverse events related to preoperative trophic feeding .
RESULTS	In the NPO group ( n = 13 ) , the mean urine L/M ratio was 0.06 at preop , 0.12 at postop day 7 , and 0.17 at postop day 14 .
RESULTS	In the trophic breast milk feeds group ( n = 14 ) , the mean urine L/M ratio was 0.09 at preop , 0.19 at postop day 7 , and 0.15 at postop day 14 .
RESULTS	In both groups , L/M ratios were significantly higher at postop day 7 and postop day 14 compared with preop ( P < .05 ) .
CONCLUSIONS	Neonates have increased intestinal permeability after cardiac surgery extending to at least postop day 14 .
CONCLUSIONS	This pilot study was not powered to detect differences in benefit or adverse events comparing the NPO and trophic breast milk feeds groups .
CONCLUSIONS	Further studies to identify mechanisms of intestinal injury and therapeutic interventions are warranted .
BACKGROUND	Registered with ClinicalTrials.gov : NCT01475357 .

###25134378
BACKGROUND	Serum procalcitonin is commonly used to differentiate systemic inflammation due to infection from non-infectious causes .
BACKGROUND	Limited data exist on the value of procalcitonin in predicting relative adrenal insufficiency ( RAI ) .
BACKGROUND	This study evaluated the value of procalcitonin in predicting RAI and mortality in cirrhotic patients with septic shock .
METHODS	This was a post-hoc analysis of a randomized placebo-controlled trial that evaluated low-dose hydrocortisone in cirrhotic patients with septic shock .
METHODS	Extracted first study-day data included serum procalcitonin , baseline serum cortisol , cortisol level after 250 microg - adrenocorticotropic hormone stimulation test and 28 - day mortality .
METHODS	RAI was defined as a baseline serum cortisol < 10 microg/dL or cortisol not rising by > 9 microg/dL after stimulation .
METHODS	Procalcitonin > 0.5 ng/mL was considered high .
RESULTS	Forty-five patients had serum procalcitonin measured ( mean = 2.7 + / - 3.2 ng/mL , first and third quartiles were 0.3 and 3.3 ng/mL , respectively ) .
RESULTS	Most ( 78 % ) patients had high procalcitonin levels .
RESULTS	RAI was present in 34 ( 76 % ) patients .
RESULTS	Patients with high procalcitonin were more likely to have RAI ( odds ratio , 4.8 ; 95 % confidence interval , 1.1 - 22.1 ) .
RESULTS	Receiver operator characteristic curve analysis showed that the best cut-off for detecting RAI was 1.0 ng/mL ( sensitivity = 79 % and specificity = 55 % ) .
RESULTS	High serum procalcitonin was not associated with 28 - day mortality ( 80 % for normal procalcitonin and 77 % for high procalcitonin , p = 0.61 ) .
CONCLUSIONS	High serum procalcitonin was highly associated with RAI in cirrhotic patients with septic shock .
CONCLUSIONS	Procalcitonin was not associated with 28 - day mortality in this patient population .

###24702700
OBJECTIVE	The efficacy and safety of insulin degludec ( IDeg ) was compared with insulin detemir ( IDet ) , both administered once daily ( OD ) as basal treatment in participants with type 1 diabetes mellitus ( T1DM ) .
OBJECTIVE	The primary outcome was non-inferiority of IDeg to IDet in glycated haemoglobin ( HbA1c ) reduction after 26 weeks .
METHODS	This multinational , 26-week , controlled , open-label , parallel-group trial randomized adults with T1DM to IDeg or IDet as OD basal insulin treatment combined with mealtime bolus insulin aspart ( IAsp ) .
METHODS	Participants with T1DM treated with any basal-bolus insulin regimen for 12 months prior to the trial , a mean HbA1c 10.0 % ( 85.8 mmol/mol ) and body mass index ( BMI ) 35.0 kg/m ( 2 ) at screening participated in the trial ( IDeg : N = 302 ; IDet : N = 153 ) .
RESULTS	After 26 weeks , HbA1c decreased 0.73 % ( 8.0 mmol/mol ) ( IDeg ) and 0.65 % ( 7.1 mmol/mol ) ( IDet ) [ estimated treatment difference ( ETD ) IDeg-IDet : -0.09 % ( -0.23 ; 0.05 ) 95 % CI ( -10.0 mmol/mol [ -2.6 ; 0.6 ] 95 % CI ) ; confirming non-inferiority ] .
RESULTS	Mean fasting plasma glucose improved in both groups , and was lower with IDeg than IDet [ ETD IDeg-IDet : -1.66 mmol/l ( -2.37 ; -0.95 ) 95 % CI , p < 0.0001 ] .
RESULTS	The rate of confirmed hypoglycaemia was similar with IDeg and IDet [ 45.83 vs. 45.69 episodes per patient-year of exposure ( PYE ) ; estimated rate ratio ( RR ) IDeg/IDet : 0.98 ( 0.80 ; 1.20 ) 95 % CI , p = 0.86 ] .
RESULTS	The rate of nocturnal confirmed hypoglycaemia was lower with IDeg than IDet [ 4.14 vs. 5.93 episodes per PYE ; RR IDeg/IDet : 0.66 ( 0.49 ; 0.88 ) 95 % CI , p = 0.0049 ] .
RESULTS	Adverse event profiles were similar between groups .
CONCLUSIONS	IDeg administered OD in basal-bolus therapy effectively improved long-term glycaemic control in participants with T1DM with a lower risk of nocturnal confirmed hypoglycaemia than IDet .

###25013997
BACKGROUND	Human growth hormone ( hGH ) replacement therapy currently requires daily sc injections for years/lifetime , which may be both inconvenient and distressing for patients .
BACKGROUND	NNC0195-0092 is a novel hGH derivative intended for once-weekly treatment of GH deficiency .
BACKGROUND	A noncovalent albumin binding moiety is attached to the hGH backbone .
BACKGROUND	Clearance is reduced as a consequence of a reversible binding to circulating serum albumin , which prolongs the pharmacodynamic ( PD ) effect .
OBJECTIVE	To evaluate safety , local tolerability , pharmacokinetics ( PK ) , and pharmacodynamics ( PD ) of a single dose ( SD ) and multiple doses ( MD ) of NNC0195-0092 .
METHODS	Randomized , single-center , placebo-controlled , double-blind , SD/MD , dose-escalation trial of 105 healthy male subjects .
METHODS	NNC0195-0092 sc administration : Five cohorts of eight subjects received one dose of NNC0195-0092 ( 0.01-0 .32 mg/kg ) ( n = 6 ) or placebo ( n = 2 ) .
METHODS	Sixteen subjects ( equal numbers of Japanese and non-Asian ) received once-weekly doses of NNC0195-0092 ( 0.02-0 .24 mg/kg ; n = 12 ) or placebo ( n = 4 ) for 4 weeks .
METHODS	Blood samples were drawn for assessment of safety , PK , IGF-1 , and IGF binding protein 3 profiles and anti-drug antibodies .
RESULTS	SD and MD of NNC0195-0092 were well tolerated at all dose levels .
RESULTS	No safety concerns or local tolerability issues were identified .
RESULTS	A dose-dependent IGF-1 response was observed .
RESULTS	IGF-1 profiles suggest that NNC0195-0092 may be suitable for once-weekly dosing , with a clinically relevant dose 0.08 mg/kg/week .
RESULTS	No differences in PK and PD were observed between Japanese and non-Asian subjects .
CONCLUSIONS	SD and MD of NNC0195-0092 administered to healthy Japanese and non-Asian male subjects were well tolerated at all doses .
CONCLUSIONS	The present trial suggests that NNC0195-0092 has the potential for an efficacious , well-tolerated , once-weekly GH treatment .

###24506529
OBJECTIVE	To compare long-term outcomes following microwave endometrial ablation ( MEA ) and thermal balloon ablation ( TBall ) .
METHODS	Follow up of a prospective , double-blind randomised controlled trial at 5years .
METHODS	A teaching hospital in the UK .
METHODS	A total of 320 women eligible for and requesting endometrial ablation .
METHODS	Eligible women were randomised in a 1:1 ratio to undergo MEA or Tball .
METHODS	Postal questionnaires were sent to participants at a minimum of 5years postoperatively to determine satisfaction with outcome , menstrual status , bleeding scores and quality of life measurement .
METHODS	Subsequent surgery was ascertained from the women and the hospital operative database .
METHODS	The primary outcome measure was overall satisfaction with treatment .
METHODS	Secondary outcomes included evaluation of menstrual loss , change in quality of life scores and subsequent surgery .
RESULTS	Of the women originally randomised 217/314 ( 69.1 % ) returned questionnaires .
RESULTS	Nonresponders were assumed to be treatment failures for data analysis .
RESULTS	The primary outcome of satisfaction was similar in both groups ( 58 % for MEA versus 53 % for TBall , difference 5 % ; 95 % CI -6 to 16 % ) .
RESULTS	Amenorrhoea rates were high following both techniques ( 51 % versus 45 % , difference 6 % ; 95 % CI -5 to 17 % ) .
RESULTS	There was no significant difference in the hysterectomy rates between the two arms ( 9 % versus 7 % , difference 2 % ; 95 % CI -5 to 9 % ) .
CONCLUSIONS	At 5years post-treatment there were no significant clinical differences in patient satisfaction , menstrual status , quality of life scores or hysterectomy rates between MEA and Thermachoice 3 , thermal balloon ablation .

###26113580
BACKGROUND	Obesity at diagnosis is associated with poor prognosis in women with breast cancer , but few reports have been adjusted for treatment factors .
METHODS	CALGB 9741 was a randomized trial of dose density and sequence of chemotherapy for node-positive breast cancer .
METHODS	All patients received doxorubicin , cyclophosphamide , and paclitaxel , dosed by actual body weight .
METHODS	Height and weight at diagnosis were abstracted from patient records , and the PAM50 assay was performed from archived specimens using the NanoString platform .
METHODS	Relationships between body mass index ( BMI ) , PAM50 , and recurrence-free and overall survival ( RFS and OS ) were evaluated using proportional hazards regression , adjusting for number of involved nodes , estrogen receptor ( ER ) status , tumor size , menopausal status , drug sequence , and dose density .
METHODS	All statistical tests were two-sided .
RESULTS	Baseline height and weight were available for 1909 of 2005 enrolled patients ; 1272 additionally had subtype determination by PAM50 .
RESULTS	Median baseline BMI was 27.4 kg/m ( 2 ) .
RESULTS	After 11 years of median follow-up , there were 619 RFS events and 543 deaths .
RESULTS	Baseline BMI was a statistically significant predictor of RFS ( adjusted hazard ratio [ HR ] for each five-unit increase in BMI = 1.08 , 95 % confidence interval [ CI ] = 1.02 to 1.14 , P = .01 ) and OS ( adjusted HR = 1.08 , 95 % CI = 1.01 to 1.14 , P = .02 ) BMI and molecular phenotypes were independent prognostic factors for RFS , with no statistically significant interactions detected .
CONCLUSIONS	BMI at diagnosis was a statistically significant prognostic factor in a group of patients receiving optimally dosed chemotherapy .
CONCLUSIONS	Additional research is needed to determine the impact of weight loss on breast cancer outcomes and to evaluate whether this impact is maintained across tumor subtypes .

###24952858
BACKGROUND	Disodium ethylenediaminetetraacetic acid ( EDTA ) reduced adverse cardiac outcomes in a factorial trial also testing oral vitamins .
BACKGROUND	This report describes the intent-to-treat comparison of the 4 factorial groups overall and in patients with diabetes .
METHODS	This was a double-blind , placebo-controlled , 2 2 factorial multicenter randomized trial of 1,708 post-myocardial infarction ( MI ) patients 50 years of age and with creatinine 2.0 mg/dL randomized to receive 40 EDTA chelation or placebo infusions plus 6 caplets daily of a 28-component multivitamin-multimineral mixture or placebo .
METHODS	The primary end point was a composite of total mortality , MI , stroke , coronary revascularization , or hospitalization for angina .
RESULTS	Median age was 65 years , 18 % were female , 94 % were Caucasian , 37 % were diabetic , 83 % had prior coronary revascularization , and 73 % were on statins .
RESULTS	Five-year Kaplan-Meier estimates for the primary end point was 31.9 % in the chelation + high-dose vitamin group , 33.7 % in the chelation + placebo vitamin group , 36.6 % in the placebo infusion + active vitamin group , and 40.2 % in the placebo infusions + placebo vitamin group .
RESULTS	The reduction in primary end point by double active treatment compared with double placebo was significant ( hazard ratio 0.74 , 95 % CI 0.57-0 .95 , P = .016 ) .
RESULTS	In patients with diabetes , the primary end point reduction of double active compared with double placebo was more pronounced ( hazard ratio 0.49 , 95 % CI 0.33-0 .75 , P < .001 ) .
CONCLUSIONS	In stable post-MI patients on evidence-based medical therapy , the combination of oral high-dose vitamins and chelation therapy compared with double placebo reduced clinically important cardiovascular events to an extent that was both statistically significant and of potential clinical relevance .

###24810870
OBJECTIVE	Benefit from antidepressant treatment such as selective serotonin reuptake inhibitors ( SSRIs ) may depend on individual differences in acute effects on neural emotion processing .
OBJECTIVE	The short ( 'S ' ) allele of the serotonin transporter ( 5-HTT ) - linked polymorphic region ( 5-HTTLPR ) is associated with both negative emotion processing biases and poorer treatment outcomes .
OBJECTIVE	Therefore , the aim of the present study was to explore the effects of 5-HTTLPR on the impact of the SSRI escitalopram during processing of positive and negative emotional images , as well as neutral stimuli .
METHODS	The study employed a double-blind , randomised , placebo-controlled crossover design on 36 healthy Caucasian female participants who underwent functional magnetic resonance imaging ( fMRI ) scanning following placebo or escitalopram treatment , separated by a 7-day washout period .
RESULTS	Changes in the left amygdala signal with escitalopram treatment during processing of emotional stimuli were linearly related to the 5-HTTLPR 'S ' allele load such that the signal to positive stimuli decreased and the signal to negative stimuli increased with an increasing number of low-expressing 'S ' alleles .
RESULTS	While 5-HTTLPR subgroups were small in size , individual subject changes with treatment and task condition increase confidence in the findings .
CONCLUSIONS	While preliminary , our findings comprise the first pharmacogenetic study demonstrating an effect of the 5-HTTLPR 'S ' allele load on escitalopram-induced changes in amygdala activity during emotional processing , consistent with a 5-HTT expression dosage model .
CONCLUSIONS	The present findings have implications for the impact of this polymorphism on antidepressant efficacy in patients with mood and anxiety disorders .

###25119609
BACKGROUND	As compared with a standard-dose vaccine , a high-dose , trivalent , inactivated influenza vaccine ( IIV3-HD ) improves antibody responses to influenza among adults 65 years of age or older .
BACKGROUND	This study evaluated whether IIV3-HD also improves protection against laboratory-confirmed influenza illness .
METHODS	We conducted a phase IIIb-IV , multicenter , randomized , double-blind , active-controlled trial to compare IIV3-HD ( 60 g of hemagglutinin per strain ) with standard-dose trivalent , inactivated influenza vaccine ( IIV3-SD [ 15 g of hemagglutinin per strain ] ) in adults 65 years of age or older .
METHODS	Assessments of relative efficacy , effectiveness , safety ( serious adverse events ) , and immunogenicity ( hemagglutination-inhibition [ HAI ] titers ) were performed during the 2011-2012 ( year 1 ) and the 2012-2013 ( year 2 ) northern-hemisphere influenza seasons .
RESULTS	A total of 31,989 participants were enrolled from 126 research centers in the United States and Canada ( 15,991 were randomly assigned to receive IIV3-HD , and 15,998 to receive IIV3-SD ) .
RESULTS	In the intention-to-treat analysis , 228 participants in the IIV3-HD group ( 1.4 % ) and 301 participants in the IIV3-SD group ( 1.9 % ) had laboratory-confirmed influenza caused by any viral type or subtype associated with a protocol-defined influenza-like illness ( relative efficacy , 24.2 % ; 95 % confidence interval [ CI ] , 9.7 to 36.5 ) .
RESULTS	At least one serious adverse event during the safety surveillance period was reported by 1323 ( 8.3 % ) of the participants in the IIV3-HD group , as compared with 1442 ( 9.0 % ) of the participants in the IIV3-SD group ( relative risk , 0.92 ; 95 % CI , 0.85 to 0.99 ) .
RESULTS	After vaccination , HAI titers and seroprotection rates ( the percentage of participants with HAI titers 1:40 ) were significantly higher in the IIV3-HD group .
RESULTS	Conclusions : Among persons 65 years of age or older , IIV3-HD induced significantly higher antibody responses and provided better protection against laboratory-confirmed influenza illness than did IIV3-SD .
RESULTS	( Funded by Sanofi Pasteur ; ClinicalTrials.gov number , NCT01427309 . )

###24410973
BACKGROUND	Increasing numbers of reports show the beneficial effects of listening to Mozart music in decreasing epileptiform discharges as well as seizure frequency in epileptic children .
BACKGROUND	There has been no effective method to reduce seizure recurrence after the first unprovoked seizure until now .
BACKGROUND	In this study , we investigated the effect of listening to Mozart K. 448 in reducing the seizure recurrence rate in children with first unprovoked seizures .
METHODS	Forty-eight children who experienced their first unprovoked seizure with epileptiform discharges were included in the study .
METHODS	They were randomly placed into treatment ( n = 24 ) and control ( n = 24 ) groups .
METHODS	Children in the treatment group listened to Mozart K. 448 daily before bedtime for at least six months .
METHODS	Two patients in the treatment group were excluded from analysis due to discontinuation intervention .
METHODS	Finally , forty-six patients were analyzed .
METHODS	Most of these patients ( 89.1 % ) were idiopathic in etiology .
METHODS	Seizure recurrence rates and reduction of epileptiform discharges were compared .
RESULTS	The average follow-up durations in the treatment and control groups were 18.6 6.6 and 20.1 5.1 months , respectively .
RESULTS	The seizure recurrence rate was estimated to be significantly lower in the treatment group than the control group over 24 months ( 37.2 % vs. 76.8 % , p = 0.0109 ) .
RESULTS	Significant decreases in epileptiform discharges were also observed after 1 , 2 , and 6 months of listening to Mozart K. 448 when compared with EEGs before listening to music .
RESULTS	There were no significant differences in gender , mentality , seizure type , and etiology between the recurrence and non-recurrence groups .
CONCLUSIONS	Although the case number was limited and control music was not performed in this study , the study revealed that listening to Mozart K. 448 reduced the seizure recurrence rate and epileptiform discharges in children with first unprovoked seizures , especially of idiopathic etiology .
CONCLUSIONS	We believe that Mozart K. 448 could be a promising alternative treatment in patients with first unprovoked seizures and abnormal EEGs .
CONCLUSIONS	Further large-scaled study should be conducted to confirm the effect .
BACKGROUND	NCT01892605 , date : June-19-2013 .

###25108506
BACKGROUND	Better diet quality has been associated with less weight gain over time .
BACKGROUND	However , few studies have examined the role of diet quality during weight loss .
BACKGROUND	This study aimed to compare changes in diet quality in overweight/obese adults during a weight loss intervention , and determine whether an association between diet quality score and weight loss exists .
METHODS	Overweight or obese ( BMI 25-40kg / m2 ) adults , aged 18-60 years , were recruited from the Hunter Region of NSW , Australia and randomized to one of three groups : a standard online weight loss program ( n = 94 ) ; an enhanced version of this online program that provided additional personalized feedback and reminders ( n = 98 ) ; or a wait-list control group ( n = 97 ) .
METHODS	Diet quality was calculated using the Australian Recommended Food Score ( ARFS ) with dietary data from the Australian Eating Survey ( AES ) Food Frequency Questionnaire at baseline and 12-weeks .
RESULTS	The basic and enhanced groups lost significantly more weight than the control group after 12weeks ( basic -2.23.4 kg , enhanced -3.04.0 kg , control 0.42.4 kg , P < 0.001 ) with no difference between the basic and enhanced groups .
RESULTS	The mean change in ARFS in the enhanced group ( 2.25.7 ) was significantly higher ( P = 0.03 ) than the control group .
RESULTS	There were no significant differences in change in ARFS between the enhanced and basic , or basic and control groups .
RESULTS	The ARFS and the fruit , meat , wholegrain , dairy and water sub-scale scores at 12weeks were significantly associated with greater weight loss ( P < 0.05 ) .
CONCLUSIONS	Diet quality improved significantly in the enhanced group compared to controls following 12-weeks intervention .
CONCLUSIONS	Furthermore , higher diet quality was associated with greater weight loss .
BACKGROUND	ACTRN12610000197033 .

###25014621
OBJECTIVE	To examine the effects of 12 weeks of high-speed resistance training ( RT ) versus low-speed RT on muscle strength [ one repetition of maximum leg-press ( 1RMLP ) and bench-press ( 1RMBP ) , plus dominant ( HGd ) and non-dominant maximum isometric handgrip ] , power [ counter-movement jump ( CMJ ) , ball throwing ( BT ) and 10-m walking sprint ( S10 ) ] , functional performance [ 8-foot up-and-go test ( UG ) and sit-to-stand test ( STS ) ] , and perceived quality of life in older women .
METHODS	45 older women were divided into a high-speed RT group [ EG , n = 15 , age = 66.33.7 y ] , a low-speed RT group [ SG , n = 15 , age = 68.76.4 y ] and a control group [ CG , n = 15 , age = 66.74.9 y ] .
METHODS	The SG and EG were submitted to a similar 12-week RT program [ 3 sets of 8 reps at 40-75 % of the one-repetition maximum ( 1 < RM ) , CMJ and BT ] using slow , controlled ( 3s ) concentric muscle actions for the SG and using fast , explosive ( < 1s ) concentric muscle actions for the EG ( 20 % less work per exercise without CMJ and BT ) .
RESULTS	Over the 12-week training period , both RT groups showed small to large clinically significant improvements in the dependent variables ; however , a significant difference was found between the EG and SG for the performance changes in BT , S10 and UG ( 20 % vs. 11 % , p < 0.05 ; 14 % vs. 9 % , p < 0.05 ; 18 % vs. 10 % , p < 0.01 ; respectively ) .
RESULTS	No significant changes were observed for the CG .
CONCLUSIONS	Both RT interventions are effective in improving functional capacity , muscle performance and quality of life in older women , although a high-speed RT program induces greater improvements in muscle power and functional capacity .

###24722960
BACKGROUND	Multiple health behavior change can ameliorate adverse effects of cancer .
OBJECTIVE	The purpose of this study was to determine the effects of a multiple health behavior change intervention ( CanChange ) for colorectal cancer survivors on psychosocial outcomes and quality of life .
METHODS	A total of 410 colorectal cancer survivors were randomized to a 6-month telephone-based health coaching intervention ( 11 sessions using acceptance and commitment therapy strategies focusing on physical activity , weight management , diet , alcohol , and smoking ) or usual care .
METHODS	Posttraumatic growth , spirituality , acceptance , mindfulness , distress , and quality of life were assessed at baseline , 6 and 12months .
RESULTS	Significant intervention effects were observed for posttraumatic growth at 6 ( 7.5 , p < 0.001 ) and 12months ( 4.1 , p = 0.033 ) , spirituality at 6months ( 1.8 , p = 0.011 ) , acceptance at 6months ( 0.2 , p = 0.005 ) , and quality of life at 6 ( 0.8 , p = 0.049 ) and 12months ( 0.9 , p = 0.037 ) .
CONCLUSIONS	The intervention improved psychosocial outcomes and quality of life ( physical well-being ) at 6months with most effects still present at 12months .
BACKGROUND	ACTRN12608000399392 ) .

###25265494
BACKGROUND	The combined inhibition of BRAF and MEK is hypothesized to improve clinical outcomes in patients with melanoma by preventing or delaying the onset of resistance observed with BRAF inhibitors alone .
BACKGROUND	This randomized phase 3 study evaluated the combination of the BRAF inhibitor vemurafenib and the MEK inhibitor cobimetinib .
METHODS	We randomly assigned 495 patients with previously untreated unresectable locally advanced or metastatic BRAF V600 mutation-positive melanoma to receive vemurafenib and cobimetinib ( combination group ) or vemurafenib and placebo ( control group ) .
METHODS	The primary end point was investigator-assessed progression-free survival .
RESULTS	The median progression-free survival was 9.9 months in the combination group and 6.2 months in the control group ( hazard ratio for death or disease progression , 0.51 ; 95 % confidence interval [ CI ] , 0.39 to 0.68 ; P < 0.001 ) .
RESULTS	The rate of complete or partial response in the combination group was 68 % , as compared with 45 % in the control group ( P < 0.001 ) , including rates of complete response of 10 % in the combination group and 4 % in the control group .
RESULTS	Progression-free survival as assessed by independent review was similar to investigator-assessed progression-free survival .
RESULTS	Interim analyses of overall survival showed 9-month survival rates of 81 % ( 95 % CI , 75 to 87 ) in the combination group and 73 % ( 95 % CI , 65 to 80 ) in the control group .
RESULTS	Vemurafenib and cobimetinib was associated with a nonsignificantly higher incidence of adverse events of grade 3 or higher , as compared with vemurafenib and placebo ( 65 % vs. 59 % ) , and there was no significant difference in the rate of study-drug discontinuation .
RESULTS	The number of secondary cutaneous cancers decreased with the combination therapy .
CONCLUSIONS	The addition of cobimetinib to vemurafenib was associated with a significant improvement in progression-free survival among patients with BRAF V600-mutated metastatic melanoma , at the cost of some increase in toxicity .
CONCLUSIONS	( Funded by F. Hoffmann-La Roche/Genentech ; coBRIM ClinicalTrials.gov number , NCT01689519 . )

###24573567
OBJECTIVE	This retrospective study assessed whether dual-source high-pitch computed tomographic angiography ( CTA ) offered advantages over single-source standard-pitch techniques in the evaluation of the ascending aorta .
METHODS	Twenty patients who received both thoracic dual-source high-pitch and single-source standard-pitch CTAs within 1 year were assessed .
METHODS	Dual-source CTAs were performed ; standard-pitch imaging used dose-modulated 120 kVp/150 mAs and 0.8 pitch compared with high-pitch protocols employing dose-modulated 120 kVp/250 mAs and 2.4 target pitch .
METHODS	Radiation dose was documented .
METHODS	Contrast-to-noise ratios ( CNRs ) at sinuses of the Valsalva ( CNRValsalva ) and ascending aorta ( CNRAorta ) were calculated .
METHODS	Dose/CNR for each technique was compared with paired t-tests .
METHODS	Motion at aortic valve , aortic root and ascending aorta were assessed with four-point scales and Mann-Whitney U tests ; longitudinal extension of motion was compared with paired t-tests .
RESULTS	Significantly lower motion scores for high-pitch , compared with standard-pitch acquisitions for aortic annulus , 0 vs. 2 , aortic root , 0 vs. 3 , and ascending aorta , 0 vs. 2 , were achieved .
RESULTS	Significantly reduced longitudinal extension of motion at aortic root , 4.9 mm vs 15.7 mm , and ascending aorta , 4.9 mm vs 21.6 mm , was observed .
RESULTS	Contrast was not impacted : CNRValsalva , 45.6 vs 46.3 , and CNRAorta , 45.3 vs 47.1 .
RESULTS	CTDIvol was significantly decreased for high-pitch acquisitions , 13.9 mGy vs 15.8 mGy .
CONCLUSIONS	Dual-source high-pitch CTAs significantly decreased motion artefact without negatively impacting vascular contrast and radiation dose .
CONCLUSIONS	Dual-source high-pitch CTA significantly decreased motion artefact of the ascending aorta .
CONCLUSIONS	Dual-source high-pitch CTA did not negatively impact on vascular contrast .
CONCLUSIONS	Dual-source high-pitch CTA significantly decreased radiation dose compared with single-source standard-pitch acquisitions .

###25633661
OBJECTIVE	To compare usual diabetes care ( UDC ) to a comprehensive diabetes care intervention condition ( IC ) involving an Internet-based `` diabetes dashboard '' management tool used by clinicians .
METHODS	We used a parallel-group randomized design .
METHODS	Diabetes nurses , diabetes dietitians , and providers used the diabetes dashboard as a clinical decision support system to deliver a five-visit , 6-month intervention to 199 poorly controlled ( HbA1c > 7.5 % [ 58 mmol/mol ] ) Latino type 2 diabetic ( T2D ) patients ( mean age 55 years , 60 % female ) at urban community health centers .
METHODS	We compared this intervention to an established , in-house UDC program ( n = 200 ) for its impact on blood glucose control and psychosocial outcomes .
RESULTS	Recruitment and retention rates were 79.0 and 88.5 % , respectively .
RESULTS	Compared with UDC , more IC patients reached HbA1c targets of < 7 % ( 53 mmol/mol ; 15.8 vs. 7.0 % , respectively , P < 0.01 ) and < 8 % ( 64 mmol/mol ; 45.2 vs. 25.3 % , respectively , P < 0.001 ) .
RESULTS	In multiple linear regression adjusting for baseline HbA1c , adjusted mean SE HbA1c at follow-up was significantly lower in the IC compared with the UDC group ( P < 0.001 ; IC 8.4 0.10 % ; UDC 9.2 0.10 % ) .
RESULTS	The results showed lower diabetes distress at follow-up for IC patients ( 40.4 2.1 ) as compared with UDC patients ( 48.3 2.0 ) ( P < 0.01 ) , and also lower social distress ( 32.2 1.3 vs. 27.2 1.4 , P < 0.01 ) .
RESULTS	There was a similar , statistically significant ( P < 0.01 ) improvement for both groups in the proportion of patients moving from depressed status at baseline to nondepressed at follow-up ( 41.8 vs. 40 % ; no significance between groups ) .
CONCLUSIONS	The diabetes dashboard intervention significantly improved diabetes-related outcomes among Latinos with poorly controlled T2D compared with a similar diabetes team condition without access to the diabetes dashboard .

###25156114
BACKGROUND	Risk factors for acquired rifampicin resistance ( ARR ) in human immunodeficiency virus ( HIV ) / tuberculosis coinfection , in the highly active antiretroviral therapy ( HAART ) era , needs evaluation .
BACKGROUND	We studied the impact of HIV and HAART on ARR among patients taking thrice-weekly antituberculosis therapy .
METHODS	This cross-protocol analysis included patients with newly diagnosed , rifampicin-susceptible pulmonary tuberculosis , with and without HIV , enrolled in clinical trials ( who took > 80 % of medication ) at the National Institute for Research in Tuberculosis between 1999 and 2013 .
METHODS	All patients received rifampicin and isoniazid for 6 months reinforced with pyrazinamide and ethambutol in the first 2 months , given thrice-weekly throughout the study along with HAART in one of the groups .
METHODS	Outcomes were categorized and multivariate logistic regression analysis performed to identify risk factors for ARR .
RESULTS	The per-protocol results included patients with tuberculosis : 246 HIV-uninfected patients ( HIV ( - ) TB ( + ) ) , 212 HIV patients not on HAART ( non-HAART ) , and 116 HIV-infected patients on HAART .
RESULTS	Median CD4 counts of the latter 2 groups were 150 and 93 cells/L , respectively , and the median viral loads were 147 000 and 266 000 copies/mL , respectively .
RESULTS	Compared with HIV ( - ) TB ( + ) , the relative risks ( RRs ) for an unfavorable response in the coinfected , non-HAART and HAART groups were 2.1 ( 95 % confidence interval [ CI ] , 1.7-14 .8 ; P < .0001 ) and 2.1 ( 95 % CI , .9 -5.2 ; P = .3 ) , whereas for ARR , the RRs were 21.1 ( 95 % CI , 2.6-184 ; P < .001 ) and 8.2 ( 95 % CI , .6 -104 ; P = .07 ) , respectively .
CONCLUSIONS	HIV-infected patients with tuberculosis treated with a thrice-weekly antituberculosis regimen are at a higher risk of ARR , compared with HIV-uninfected patients , in the presence of baseline isoniazid resistance .
CONCLUSIONS	HAART reduces but does not eliminate the risk of ARR .

###25185483
BACKGROUND	Poor governance and accountability compromise young democracies ' efforts to provide public services critical for human development , including water , sanitation , health , and education .
BACKGROUND	Evidence shows that accountability agencies like superior audit institutions can reduce corruption and waste in federal grant programs financing service infrastructure .
BACKGROUND	However , little is know about their effect on compliance with grant reporting and resource allocation requirements , or about the causal mechanisms .
BACKGROUND	This study protocol for an exploratory randomized controlled trial tests the hypothesis that federal and state audits increase compliance with a federal grant program to improve municipal service infrastructure serving marginalized households .
METHODS	The AUDIT study is a block randomized , controlled , three-arm parallel group exploratory trial .
METHODS	A convenience sample of 5 municipalities in each of 17 states in Mexico ( n = 85 ) were block randomized to be audited by federal auditors ( n = 17 ) , by state auditors ( n = 17 ) , and a control condition outside the annual program of audits ( n = 51 ) in a 1:1:3 ratio .
METHODS	Replicable and verifiable randomization was performed using publicly available lottery numbers .
METHODS	Audited municipalities were included in the national program of audits and received standard audits on their use of federal public service infrastructure grants .
METHODS	Municipalities receiving moderate levels of grant transfers were recruited , as these were outside the auditing sampling frame -- and hence audit program -- or had negligible probabilities of ever being audited .
METHODS	The primary outcome measures capture compliance with the grant program and markers for the causal mechanisms , including deterrence and information effects .
METHODS	Secondary outcome measure include differences in audit reports across federal and state auditors , and measures like career concerns , political promotions , and political clientelism capturing synergistic effects with municipal accountability systems .
METHODS	The survey firm and research assistants assessing outcomes were blind to treatment status .
CONCLUSIONS	This study will improve our understanding of local accountability systems for public service delivery in the 17 states under study , and may have downstream policy implications .
CONCLUSIONS	The study design also demonstrates the use of verifiable and replicable randomization , and of sequentially partitioned hypotheses to reduce the Type I error rate in multiple hypothesis tests .
BACKGROUND	Controlled-trials .
BACKGROUND	com Identifier ISRCTN22381841 : Date registered 02/11/2012 .

###25113138
BACKGROUND	Since the 2008 inception of universal childhood influenza vaccination , national rates have risen more dramatically among younger children than older children and reported rates across racial/ethnic groups are inconsistent .
BACKGROUND	Interventions may be needed to address age and racial disparities to achieve the recommended childhood influenza vaccination target of 70 % .
OBJECTIVE	To evaluate an intervention to increase childhood influenza vaccination across age and racial groups .
METHODS	In 2011-2012 , a total of 20 primary care practices treating children were randomly assigned to the intervention and control arms of a cluster randomized controlled trial to increase childhood influenza vaccination uptake using a toolkit and other strategies including early delivery of donated vaccine , in-service staff meetings , and publicity .
RESULTS	The average vaccination differences from pre-intervention to the intervention year were significantly larger in the intervention arm ( n = 10 practices ) than the control arm ( n = 10 practices ) ; for children aged 9-18 years ( 11.1 pct pts intervention vs 4.3 pct pts control , p < 0.05 ) ; for non-white children ( 16.7 pct pts intervention vs 4.6 pct pts control , p < 0.001 ) ; and overall ( 9.9 pct pts intervention vs 4.2 pct pts control , p < 0.01 ) .
RESULTS	In multi-level modeling that accounted for person - and practice-level variables and the interactions among age , race , and intervention , the likelihood of vaccination increased with younger age group ( 6-23 months ) ; white race ; commercial insurance ; the practice 's pre-intervention vaccination rate ; and being in the intervention arm .
RESULTS	Estimates of the interaction terms indicated that the intervention increased the likelihood of vaccination for non-white children in all age groups and white children aged 9-18 years .
CONCLUSIONS	A multi-strategy intervention that includes a practice improvement toolkit can significantly improve influenza vaccination uptake across age and racial groups without targeting specific groups , especially in practices with large percentages of minority children .

###25243536
OBJECTIVE	Little evidence exists on which exercise modality is optimal for obese adolescents .
OBJECTIVE	To determine the effects of aerobic training , resistance training , and combined training on percentage body fat in overweight and obese adolescents .
METHODS	Randomized , parallel-group clinical trial at community-based exercise facilities in Ottawa ( Ontario ) and Gatineau ( Quebec ) , Canada , among previously inactive postpubertal adolescents aged 14 to 18 years ( Tanner stage IV or V ) with body mass index at or above the 95th percentile for age and sex or at or above the 85th percentile plus an additional diabetes mellitus or cardiovascular risk factor .
METHODS	After a 4-week run-in period , 304 participants were randomized to the following 4 groups for 22 weeks : aerobic training ( n = 75 ) , resistance training ( n = 78 ) , combined aerobic and resistance training ( n = 75 ) , or nonexercising control ( n = 76 ) .
METHODS	All participants received dietary counseling , with a daily energy deficit of 250 kcal .
METHODS	The primary outcome was percentage body fat measured by magnetic resonance imaging at baseline and 6 months .
METHODS	We hypothesized that aerobic training and resistance training would each yield greater decreases than the control and that combined training would cause greater decreases than aerobic or resistance training alone .
RESULTS	Decreases in percentage body fat were -0.3 ( 95 % CI , -0.9 to 0.3 ) in the control group , -1.1 ( 95 % CI , -1.7 to -0.5 ) in the aerobic training group ( P = .06 vs controls ) , and -1.6 ( 95 % CI , -2.2 to -1.0 ) in the resistance training group ( P = .002 vs controls ) .
RESULTS	The -1.4 ( 95 % CI , -2.0 to -0.8 ) decrease in the combined training group did not differ significantly from that in the aerobic or resistance training group .
RESULTS	Waist circumference changes were -0.2 ( 95 % CI , -1.7 to 1.2 ) cm in the control group , -3.0 ( 95 % CI , -4.4 to -1.6 ) cm in the aerobic group ( P = .006 vs controls ) , -2.2 ( 95 % CI -3.7 to -0.8 ) cm in the resistance training group ( P = .048 vs controls ) , and -4.1 ( 95 % CI , -5.5 to -2.7 ) cm in the combined training group .
RESULTS	In per-protocol analyses ( 70 % adherence ) , the combined training group had greater changes in percentage body fat ( -2.4 , 95 % CI , -3.2 to -1.6 ) vs the aerobic group ( -1.2 ; 95 % CI , -2.0 to -0.5 ; P = .04 vs the combined group ) but not the resistance group ( -1.6 ; 95 % CI , -2.5 to -0.8 ) .
CONCLUSIONS	Aerobic , resistance , and combined training reduced total body fat and waist circumference in obese adolescents .
CONCLUSIONS	In more adherent participants , combined training may cause greater decreases than aerobic or resistance training alone .
BACKGROUND	clinicaltrials.gov Identifier : NCT00195858 .

###24837889
OBJECTIVE	To assess the safety and efficacy of combining oncolytic adenovirus-mediated cytotoxic gene therapy ( OAMCGT ) with intensity modulated radiation therapy ( IMRT ) in intermediate-risk prostate cancer .
METHODS	Forty-four men with intermediate-risk prostate cancer were randomly assigned to receive either OAMCGT plus IMRT ( arm 1 ; n = 21 ) or IMRT only ( arm 2 ; n = 23 ) .
METHODS	The primary phase 2 endpoint was acute ( 90 days ) toxicity .
METHODS	Secondary endpoints included quality of life ( QOL ) , prostate biopsy ( 12-core ) positivity at 2 years , freedom from biochemical/clinical failure ( FFF ) , freedom from metastases , and survival .
RESULTS	Men in arm 1 exhibited a greater incidence of low-grade influenza-like symptoms , transaminitis , neutropenia , and thrombocytopenia than men in arm 2 .
RESULTS	There were no significant differences in gastrointestinal or genitourinary events or QOL between the 2 arms .
RESULTS	Two-year prostate biopsies were obtained from 37 men ( 84 % ) .
RESULTS	Thirty-three percent of men in arm 1 were biopsy-positive versus 58 % in arm 2 , representing a 42 % relative reduction in biopsy positivity in the investigational arm ( P = .13 ) .
RESULTS	There was a 60 % relative reduction in biopsy positivity in the investigational arm in men with < 50 % positive biopsy cores at baseline ( P = .07 ) .
RESULTS	To date , 1 patient in each arm exhibited biochemical failure ( arm 1 , 4.8 % ; arm 2 , 4.3 % ) .
RESULTS	No patient developed hormone-refractory or metastatic disease , and none has died from prostate cancer .
CONCLUSIONS	Combining OAMCGT with IMRT does not exacerbate the most common side effects of prostate radiation therapy and suggests a clinically meaningful reduction in positive biopsy results at 2 years in men with intermediate-risk prostate cancer .

###24814735
BACKGROUND	Medication reconciliation improves congruence in cross sectional patient courses .
BACKGROUND	Our regional electronic medical record ( EMR ) integrates the shared medication record ( SMR ) which provides full access to current medication and medication prescriptions for all citizens in Denmark .
BACKGROUND	We studied whether our SMR integration could facilitate medication reconciliation .
METHODS	Patients admitted to the emergency department for hospitalization were randomised to consultation using EMR with or without the integrated SMR access .
METHODS	Observed time used for medication reconciliation was the primary efficacy parameter .
RESULTS	A total of 62 consecutive patient consultations were randomised including 39 with more than five prescriptions .
RESULTS	EMR had data from previous consultations for 46 patients , 59 patients provided information on medication .
RESULTS	In all , 18 junior physicians in early postgraduate medical training each participated with a median of three consultations ( range 1-9 ) .
RESULTS	Time expenditure for medicine reconciliation was 5:27 min. : sec .
RESULTS	( range : 2:00 -15:37 ) with access to SMR integration and 4:15 min. : sec .
RESULTS	( 1:15 -12:00 ) without SMR access .
RESULTS	The number of active medicine prescriptions was eight and nine , respectively .
RESULTS	Incorporating SMR did not increase the work load .
RESULTS	Physicians judged the SMR integration and workflow as being useful .
RESULTS	Patients unambiguously sup-ported physicians ' use of SMR in this setting .
CONCLUSIONS	Integration of information on individuals ' medication from a national SMR into a hospital EMR was feasible and useful , and it did not increase time expenditure for medication reconciliation .
BACKGROUND	not relevant .
BACKGROUND	not relevant .

###25576433
OBJECTIVE	Pegfilgrastim is a pegylated form of filgrastim , a recombinant protein of granulocyte colony-stimulating factor , that is used to reduce the risk of febrile neutropenia ( FN ) .
OBJECTIVE	Here , we report the results of a phase III trial of pegfilgrastim in breast cancer patients receiving docetaxel and cyclophosphamide ( TC ) chemotherapy .
METHODS	We conducted a double-blind , placebo-controlled , randomized trial to determine the efficacy of pegfilgrastim in reducing the risk of FN in early-stage breast cancer patients .
METHODS	A total of 351 women ( 177 in the pegfilgrastim group and 174 in the placebo group ) between 20 and 69 years of age with stage I-III invasive breast carcinoma who were to receive TC chemotherapy ( docetaxel 75 mg/m ( 2 ) and cyclophosphamide 600 mg/m ( 2 ) every 3 weeks ) as either neoadjuvant or adjuvant therapy were enrolled ; 346 of these patients were treated with either pegfilgrastim ( n = 173 ) or placebo ( n = 173 ) .
RESULTS	The incidence of FN was significantly lower in the pegfilgrastim group than in the placebo group ( 1.2 vs. 68.8 % , respectively ; P < 0.001 ) .
RESULTS	In addition , patients in the pegfilgrastim group required less hospitalization and antibiotics for FN .
RESULTS	Most adverse events were consistent with those expected for breast cancer subjects receiving TC chemotherapy .
CONCLUSIONS	Pegfilgrastim is safe and significantly reduces the incidence of FN in breast cancer patients .

###24314853
OBJECTIVE	Cerebral palsy ( CP ) is a disabling condition characterized by the motor impairment , which is difficult to be ameliorated .
OBJECTIVE	In the brain of infants with CP , there are persistent pathomechanisms including accentuated neuroinflammation .
OBJECTIVE	Since erythropoietin was demonstrated to have neuroprotective effect via anti-inflammatory and anti-apoptotic properties , we hypothesized that the administration of recombinant human EPO ( rhEPO ) could help children with CP , especially young infants .
METHODS	We investigated the therapeutic efficacy of rhEPO for infants with CP , who had been undergoing active rehabilitation in hospitalized setting to eliminate treatment bias .
METHODS	Twenty infants with CP were randomly divided into EPO or control group equally .
METHODS	We compared the changes in the Gross Motor Function Measure ( GMFM ) and the Bayley Scales of Infant Development-II ( BSID-II ) scores during one month of hospitalization between two groups .
RESULTS	The improvements after 1 month on the GMFM A and GMFM total scores differed significantly between the groups ( p = 0.003 , p = 0.04 , respectively ) .
RESULTS	However , the changes after 6 months were not different between the two groups .
RESULTS	The scores of BSID-II did not show any differences at 1-month and 6-months post-treatment .
CONCLUSIONS	These results indicated that rhEPO could have therapeutic efficacy for infants with CP during the active rehabilitation and anti-inflammation was suggested to be one of its therapeutic mechanisms .

###24732651
BACKGROUND	The authors aimed to assess the effect of lower extremity nerve decompression surgery for painful diabetic polyneuropathy on pain and sensibility .
METHODS	The study was conducted as a single-center randomized controlled trial of one intervention with 1-year follow-up .
METHODS	Forty-two patients with painful diabetic neuropathy were included .
METHODS	After randomization , the lower extremity nerves were decompressed at four sites in one limb .
METHODS	The contralateral limb was used as control ( within-patient comparison ) .
METHODS	All patients were assessed preoperatively and at 3 , 6 , and 12 months postoperatively .
METHODS	Primary outcome was the visual analogue scale score 12 months after surgery .
METHODS	Secondary outcomes were Semmes Weinstein monofilament testing and two-point discrimination outcomes at 3 , 6 , and 12 months .
RESULTS	Visual analogue scale scores improved significantly from a mean of 6.1 ( 95 percent CI , 5.5 to 6.7 ) preoperatively to 3.5 ( 95 percent CI , 2.5 to 4.4 ) at 12 months postoperatively ( p < 0.001 ) .
RESULTS	The score was also significantly lower compared with the control leg score of 5.3 ( 95 percent CI , 4.4 to 6.2 ; p < 0.001 ) at 12 months .
RESULTS	Overall , 73.7 percent of the patients improved their score on the visual analogue scale , of which 35.7 percent had a decrease of more than five points .
CONCLUSIONS	Surgical decompression of the nerves of the lower extremity can be added as a therapeutic option for patients with painful diabetic neuropathy who show signs of chronic nerve compression by means of a positive Tinel or other diagnostic criteria , when pain medication fails to reduce pain to an acceptable standard .
METHODS	Therapeutic , I.

###25201152
BACKGROUND	Acetylsalicylic acid is one of the most used analgesics to treat an acute migraine attack .
BACKGROUND	Next to the inhibitory effects on peripheral prostaglandin synthesis , central mechanisms of action have also been discussed .
METHODS	Using a standardized model for trigeminal-nociceptive stimulation during fMRI scanning , we investigated the effect of acetylsalicylic acid on acute pain compared to saline in 22 healthy volunteers in a double-blind within-subject design .
METHODS	Painful stimulation was applied using gaseous ammonia and presented in a pseudo-randomized order with several control stimuli .
METHODS	All participants were instructed to rate the intensity and unpleasantness of every stimulus on a VAS scale .
METHODS	Based on previous results , we hypothesized to find an effect of ASA on central pain processing structures like the ACC , SI and SII as well as the trigeminal nuclei and the hypothalamus .
RESULTS	Even though we did not find any differences in pain ratings between saline and ASA , we observed decreased BOLD signal changes in response to trigemino-nociceptive stimulation in the ACC and SII after administration of ASA compared to saline .
RESULTS	This finding is in line with earlier imaging results investigating the effect of ASA on acute pain .
RESULTS	Contrary to earlier findings from animal studies , we could not find an effect of ASA on the trigeminal nuclei in the brainstem or within the hypothalamic area .
CONCLUSIONS	Taken together our study replicates earlier findings of an attenuating effect of ASA on pain processing structures , which adds further evidence to a possibly central mechanism of action of ASA .

###25028457
BACKGROUND	The Prostate Cancer Prevention Trial ( PCPT ) was a 7-year randomized , double-blind , placebo-controlled trial of the efficacy of finasteride for the prevention of prostate cancer with a primary outcome of histologically determined prevalence of prostate cancer at the end of 7 years .
METHODS	A systematic modeling process using logistic regression identified factors available at year 6 that are associated with end-of-study ( EOS ) biopsy adherence at year 7 , stratified by whether participants were ever prompted for a prostate biopsy by year 6 .
METHODS	Final models were evaluated for discrimination .
METHODS	At year 6 , 13,590 men were available for analysis .
RESULTS	Participants were more likely to have the EOS biopsy if they were adherent to study visit schedules and procedures and/or were in good health ( P < 0.01 ) .
RESULTS	Participants at larger sites and/or sites that received retention and adherence grants were also more likely to have the EOS biopsy ( P < 0.05 ) .
CONCLUSIONS	Our results show good adherence to study requirements 1 year before the EOS biopsy was associated with greater odds that a participant would comply with the invasive EOS requirement .
CONCLUSIONS	Monitoring adherence behaviors may identify participants at risk of nonadherence to more demanding study end points .
CONCLUSIONS	Such information could help frame adherence intervention strategies in future trials .

###25093754
BACKGROUND	Chemoprevention offers a promising strategy for prevention of malaria in African children .
BACKGROUND	However , the optimal chemoprevention drug and dosing strategy is unclear in areas of year-round transmission and resistance to many antimalarial drugs .
BACKGROUND	To compare three available regimens , we conducted an open-label randomized controlled trial of chemoprevention in Ugandan children .
RESULTS	This study was conducted between June 28 , 2010 , and September 25 , 2013.400 infants were enrolled and 393 randomized at 6 mo of age to no chemoprevention , monthly sulfadoxine-pyrimethamine ( SP ) , daily trimethoprim-sulfamethoxazole ( TS ) , or monthly dihydroartemisinin-piperaquine ( DP ) .
RESULTS	Study drugs were administered at home without supervision .
RESULTS	Piperaquine ( PQ ) levels were used as a measure of compliance in the DP arm .
RESULTS	Participants were given insecticide-treated bednets , and caregivers were encouraged to bring their child to a study clinic whenever they were ill .
RESULTS	Chemoprevention was stopped at 24 mo of age , and participants followed-up an additional year .
RESULTS	Primary outcome was the incidence of malaria during the intervention period .
RESULTS	During the intervention , the incidence of malaria in the no chemoprevention arm was 6.95 episodes per person-year at risk .
RESULTS	Protective efficacy was 58 % ( 95 % CI , 45 % -67 % , p < 0.001 ) for DP , 28 % ( 95 % CI , 7 % -44 % , p = 0.01 ) for TS , and 7 % for SP ( 95 % CI , -19 % to 28 % , p = 0.57 ) .
RESULTS	PQ levels were below the detection limit 52 % of the time when malaria was diagnosed in the DP arm , suggesting non-adherence .
RESULTS	There were no differences between the study arms in the incidence of serious adverse events during the intervention and the incidence of malaria during the 1-y period after the intervention was stopped .
CONCLUSIONS	For preventing malaria in children living in an area of high transmission intensity , monthly DP was the most efficacious and safe , although adherence may pose a problem .
CONCLUSIONS	Monthly SP and daily TS may not be appropriate in areas with high transmission intensity and frequent resistance to antifolates .
BACKGROUND	www.ClinicalTrials.gov NCT00948896 Please see later in the article for the Editors ' Summary .

###25780304
OBJECTIVE	To investigate the electrolyte changes between 2-L polyethylene glycol with ascorbic acid 20 g ( PEG-Asc ) and 4-L PEG solutions .
METHODS	From August 2012 to February 2013 , a total of 226 patients were enrolled at four tertiary hospitals .
METHODS	All patients were randomly allocated to a PEG-Asc group or a 4-L PEG .
METHODS	Before colonoscopy , patients completed a questionnaire to assess bowel preparation-related symptoms , satisfaction , and willingness .
METHODS	Endoscopists assessed the bowel preparation using the Boston Bowel Preparation Scale ( BBPS ) .
METHODS	In addition , blood tests , including serum electrolytes , serum osmolarity , and urine osmolarity were evaluated both before and after the procedure .
RESULTS	A total of 226 patients were analyzed .
RESULTS	BBPS scores were similar and the adequate bowel preparation rate ( BBPS 6 ) was not different between the two groups ( PEG-Asc vs 4-L PEG , 73.2 % vs 76.3 % , P = 0.760 ) .
RESULTS	Bowel preparation-related symptoms also were not different between the two groups .
RESULTS	The taste of PEG-Asc was better ( 41.1 % vs 16.7 % , P < 0.001 ) , and the willingness to undergo repeated bowel preparation was higher in the PEG-Asc group ( 73.2 % vs 59.3 % , P = 0.027 ) than in 4-L PEG .
RESULTS	There were no significant changes in serum electrolytes in either group .
CONCLUSIONS	In this multicenter trial , bowel preparation with PEG-Asc was better than 4-L PEG in terms of patient satisfaction , with similar degrees of bowel preparation and electrolyte changes .

###24379328
BACKGROUND	The authors evaluated the effectiveness of using a patient simulator ( MARC Patient Simulator [ MARC PS ] , BlueLight analytics , Halifax , Nova Scotia , Canada ) , to instruct dental students ( DS ) on how to deliver energy optimally to a restoration from a curing light .
BACKGROUND	Five months later , the authors evaluated the retention of the instruction provided to the DS .
METHODS	Toward the end of the DS ' first year of dental education , the authors evaluated the light-curing techniques of one-half of the class of first-year DS ( Group 1 ) before and after receiving instruction by means of the patient simulator .
METHODS	Five months later , they retested DS in Group 1 and tested the remaining first-year DS who were then second-year DS and who had received no instruction by means of the patient simulator ( Group 2 ) .
METHODS	They gave DS in Group 1 and Group 2 MARC PS instruction and retested them .
METHODS	The authors also the tested fourth-year DS ( Group 3 ) and dentists ( Group 4 ) by using the MARC PS before giving any instruction by means of the MARC PS .
RESULTS	The results of one-way analysis of variance ( ANOVA ) showed that there were no significant differences in the ability of dentists and DS to light cure a simulated restoration before they received instruction by means of the patient simulator ( P = .26 ) .
RESULTS	The results of two-way ANOVA and Fisher protected least significant difference tests showed that after receiving instruction by means of the patient simulator , DS delivered significantly more energy to a simulated restoration , and this skill was retained .
RESULTS	There were no significant differences between DS in Group 1 and Group 2 after they had received instruction by means of the patient simulator .
CONCLUSIONS	The abilities of dentists and DS to light cure a simulated restoration were not significantly different .
CONCLUSIONS	Hands-on teaching using a patient simulator enhanced the ability of DS to use a curing light .
CONCLUSIONS	This skill was retained for at least five months .
CONCLUSIONS	The education provided to dentists and DS is insufficient to teach them how to deliver the optimum amount of energy from a curing light .
CONCLUSIONS	Better teaching and understanding of the importance of light curing is required .

###24393305
BACKGROUND	Carers provide extended and often unrecognized support to people with cancer .
BACKGROUND	The aim of this study is to test the hypothesis that excessive carer burden is modifiable through a telephone outcall intervention that includes supportive care , information and referral to appropriate psycho-social services .
BACKGROUND	Secondary aims include estimation of changes in psychological health and quality of life .
BACKGROUND	The study will determine whether the intervention reduces unmet needs among patient dyads .
BACKGROUND	A formal economic program will also be conducted .
METHODS	This study is a single-blind , multi-centre , randomized controlled trial to determine the efficacy and cost-efficacy of a telephone outcall program among carers of newly diagnosed cancer patients .
METHODS	A total of 230 carer/patient dyads will be recruited into the study ; following written consent , carers will be randomly allocated to either the outcall intervention program ( n = 115 ) or to a minimal outcall / attention control service ( n = 115 ) .
METHODS	Carer assessments will occur at baseline , at one and six months post-intervention .
METHODS	The primary outcome is change in carer burden ; the secondary outcomes are change in carer depression , quality of life , health literacy and unmet needs .
METHODS	The trial patients will be assessed at baseline and one month post-intervention to determine depression levels and unmet needs .
METHODS	The economic analysis will include perspectives of both the health care sector and broader society and comprise a cost-consequences analysis where all outcomes will be compared to costs .
CONCLUSIONS	This study will contribute to our understanding on the potential impact of a telephone outcall program on carer burden and provide new evidence on an approach for improving the wellbeing of carers .

###25401715
BACKGROUND	Pooled analysis is a powerful technique that is increasingly used to detect differences in efficacy between pharmacologic agents .
BACKGROUND	Some studies have compared the efficacy and tolerability of citalopram and escitalopram , with contradictory results .
BACKGROUND	The aim of this study was to compare the efficacy and tolerability of citalopram and escitalopram in the treatment of major depressive disorder ( MDD ) using pooled analyses .
METHODS	Data from 3 randomized , double-blind studies that compared citalopram ( 20 to 40 mg/d ) and escitalopram ( 10 to 20 mg/d ) were pooled and analyzed .
METHODS	The primary efficacy parameter was change from baseline in the 17-item Hamilton Rating Scale for Depression ( HAM-D-17 ) total score .
METHODS	Efficacy assessments were made at weeks 0 ( baseline ) , 1 , 2 , 4 , and 6 .
RESULTS	Based on the mean change from baseline in the HAM-D-17 at weeks 1 , 2 , 4 , and 6 , the efficacy of citalopram , 20 to 40 mg/d , was equivalent to escitalopram , 10 to 20 mg/d ( P > .05 ) .
RESULTS	Similar results were seen for severely depressed patients , with a mean treatment difference of 13.9 ( SE = 7.6 ) vs 15.9 ( SE = 7.5 ) .
RESULTS	Response and remission rates at week 6 were similar ( response , 72.4 % for citalopram , compared with 73.5 % for escitalopram ; remission , 52.6 % vs 54.5 % , respectively ) .
CONCLUSIONS	The pooled analysis showed that over a 6-week treatment period , citalopram , 20 to 40 mg/d , is equivalent to escitalopram , 10 to 20 mg/d , in both efficacy and tolerability .

###24277510
OBJECTIVE	This study was done to compare percutaneous laser ablation ( PLA ) and radiofrequency thermoablation ( RFA ) for the treatment of hepatocellular carcinoma ( HCC ) 4 cm , in patients with liver cirrhosis .
METHODS	Thirty patients with single HCC 4 cm in diameter were randomly assigned to one of two treatments : 15 patients were treated with PLA , using a multifibre system connected to a neodymium yttrium-aluminium-garnet laser source ; 15 patients were treated with RFA , using an expandable needle electrode .
METHODS	Patients were followed up for up to 12 months .
RESULTS	A complete response was obtained in 87 % lesions treated with PLA and in 93 % lesions treated with RFA ( p = ns ) .
RESULTS	The overall local recurrence-free survival rates at 3 , 6 and 12 months were comparable .
RESULTS	However , a higher rate of recurrence was observed in the PLA group for lesions 21 mm ( p = 0.0081 ) .
RESULTS	A postablation syndrome was documented in 13 patients ( 1 PLA ; 12 RFA ) .
RESULTS	Tumour necrosis factor - was significantly higher in the RFA group ( p < 0.05 ) .
CONCLUSIONS	RFA is more effective in the treatment of HCC compared to PLA for lesions 21 mm .
CONCLUSIONS	However , PLA should be considered a viable treatment option for HCC 20 mm , in view of the lower incidence of complications .

###24240777
OBJECTIVE	Although the benefit of reducing blood pressure for primary and secondary prevention of stroke has been established , the effect of antihypertensive treatment in patients with acute ischemic stroke is uncertain .
OBJECTIVE	To evaluate whether immediate blood pressure reduction in patients with acute ischemic stroke would reduce death and major disability at 14 days or hospital discharge .
METHODS	The China Antihypertensive Trial in Acute Ischemic Stroke , a single-blind , blinded end-points randomized clinical trial , conducted among 4071 patients with nonthrombolysed ischemic stroke within 48 hours of onset and elevated systolic blood pressure .
METHODS	Patients were recruited from 26 hospitals across China between August 2009 and May 2013 .
METHODS	Patients ( n = 2038 ) were randomly assigned to receive antihypertensive treatment ( aimed at lowering systolic blood pressure by 10 % to 25 % within the first 24 hours after randomization , achieving blood pressure less than 140/90 mm Hg within 7 days , and maintaining this level during hospitalization ) or to discontinue all antihypertensive medications ( control ) during hospitalization ( n = 2033 ) .
METHODS	Primary outcome was a combination of death and major disability ( modified Rankin Scale score 3 ) at 14 days or hospital discharge .
RESULTS	Mean systolic blood pressure was reduced from 166.7 mm Hg to 144.7 mm Hg ( -12.7 % ) within 24 hours in the antihypertensive treatment group and from 165.6 mm Hg to 152.9 mm Hg ( -7.2 % ) in the control group within 24 hours after randomization ( difference , -5.5 % [ 95 % CI , -4.9 to -6.1 % ] ; absolute difference , -9.1 mm Hg [ 95 % CI , -10.2 to -8.1 ] ; P < .001 ) .
RESULTS	Mean systolic blood pressure was 137.3 mm Hg in the antihypertensive treatment group and 146.5 mm Hg in the control group at day 7 after randomization ( difference , -9.3 mm Hg [ 95 % CI , -10.1 to -8.4 ] ; P < .001 ) .
RESULTS	The primary outcome did not differ between treatment groups ( 683 events [ antihypertensive treatment ] vs 681 events [ control ] ; odds ratio , 1.00 [ 95 % CI , 0.88 to 1.14 ] ; P = .98 ) at 14 days or hospital discharge .
RESULTS	The secondary composite outcome of death and major disability at 3-month posttreatment follow-up did not differ between treatment groups ( 500 events [ antihypertensive treatment ] vs 502 events [ control ] ; odds ratio , 0.99 [ 95 % CI , 0.86 to 1.15 ] ; P = .93 ) .
CONCLUSIONS	Among patients with acute ischemic stroke , blood pressure reduction with antihypertensive medications , compared with the absence of hypertensive medication , did not reduce the likelihood of death and major disability at 14 days or hospital discharge .
BACKGROUND	clinicaltrials.gov Identifier : NCT01840072 .

###24659022
BACKGROUND	Reactivity to smoking cues is an important factor in the motivation to smoke and has been associated with the dopamine receptor 4 variable number tandem repeat ( DRD4 exon III VNTR ) polymorphism .
BACKGROUND	However , little is known about the associated neural mechanisms .
METHODS	Non-treatment-seeking Caucasian smokers completed overnight abstinence and viewed smoking and neutral cues during 2 separate functional magnetic resonance imaging scans while wearing either a nicotine or placebo patch ( order randomized ) and were genotyped for the DRD4 VNTR .
METHODS	We conducted mixed-effects repeated-measures analyses of variance ( within-subject factor : nicotine or placebo patch ; between-subject factor : DRD4 long [ L : 1 copy of 7 repeats ] or short [ S : 2 copies 6 repeats ] genotype ) of 6 a priori regions of interest .
RESULTS	Relative to neutral cues , smoking cues elicited greater activity in bilateral ventral striatum and left amygdala during nicotine replacement and deactivation in these regions during nicotine deprivation .
RESULTS	A patch DRD4 interaction was observed in the left amygdala , an area associated with appetitive reinforcement and relapse risk , such that S allele carriers demonstrated greater activation on active patch than on placebo patch .
CONCLUSIONS	Brain systems associated with reward salience may become primed and overreactive at nicotine replacement doses intended for the first step of smoking cessation and may become inhibited during nicotine withdrawal in DRD4 S but not in DRD4 L carriers .
CONCLUSIONS	These findings are consistent with the role of these regions in drug reinforcement and suggest a differential influence of nicotine replacement on amygdala activation in the association of incentive salience with smoking stimuli across DRD4 genotypes .

###24670891
OBJECTIVE	This double-blind , randomized , placebo-controlled study investigated the impact of repetitive transcranial magnetic stimulation ( rTMS ) on quality of life ( QoL ) of patients with fibromyalgia , and its possible brain metabolic substrate .
METHODS	Thirty-eight patients were randomly assigned to receive high-frequency rTMS ( n = 19 ) or sham stimulation ( n = 19 ) , applied to left primary motor cortex in 14 sessions over 10 weeks .
METHODS	Primary clinical outcomes were QoL changes at the end of week 11 , measured using the Fibromyalgia Impact Questionnaire ( FIQ ) .
METHODS	Secondary clinical outcomes were mental and physical QoL component measured using the 36-Item Short Form Health Survey ( SF-36 ) , but also pain , mood , and anxiety .
METHODS	Resting-state [ ( 18 ) F ] - fluorodeoxyglucose-PET metabolism was assessed at baseline , week 2 , and week 11 .
METHODS	Whole-brain voxel-based analysis was performed to study between-group metabolic changes over time .
RESULTS	At week 11 , patients of the active rTMS group had greater QoL improvement in the FIQ ( p = 0.032 ) and in the mental component of the SF-36 ( p = 0.019 ) than the sham stimulation group .
RESULTS	No significant impact was found for other clinical outcomes .
RESULTS	Compared with the sham stimulation group , patients of the active rTMS group presented an increase in right medial temporal metabolism between baseline and week 11 ( p < 0.001 ) , which was correlated with FIQ and mental component SF-36 concomitant changes ( r = -0.38 , p = 0.043 ; r = 0.51 , p = 0.009 , respectively ) .
RESULTS	QoL improvement involved mainly affective , emotional , and social dimensions .
CONCLUSIONS	Our study shows that rTMS improves QoL of patients with fibromyalgia .
CONCLUSIONS	This improvement is associated with a concomitant increase in right limbic metabolism , arguing for a neural substrate to the impact of rTMS on emotional dimensions involved in QoL .
METHODS	This study provides Class II evidence that rTMS compared with sham rTMS improves QoL in patients with fibromyalgia .

###24624241
BACKGROUND	Long-term Mechanical Low-Back Pain ( LMLBP ) negatively impacts on patients ' physical capacity and quality of life .
BACKGROUND	This study investigated the relationship between Health-Related Quality of Life ( HRQoL ) and pain intensity , and the influence of static and dynamic back extensors ' endurance exercises on HRQoL in Nigerian patients with LMLBP treated with the McKenzie Protocol ( MP ) .
METHODS	A single-blind controlled trial involving 84 patients who received treatment thrice weekly for eight weeks was conducted .
METHODS	Participants were assigned to the MP Group ( MPG ) , MP plus Static Back Endurance Exercise Group ( MPSBEEG ) or MP plus Dynamic Endurance Exercise Group ( MPDBEEG ) using permuted randomization .
METHODS	HRQoL and pain was assessed using the Short-Form ( SF-36 ) questionnaire and Quadruple Visual Analogue Scale respectively .
RESULTS	Sixty seven participants aged 51.8 7.35 years completed the study .
RESULTS	A total drop-out rate of 20.2 % was observed in the study .
RESULTS	Within-group comparison across weeks 0-4 , 4-8 and 0-8 of the study revealed significant differences in HRQoL scores ( p < 0.05 ) .
RESULTS	Treatment Effect Scores ( TES ) across the groups were significantly different ( p = 0.001 ) .
RESULTS	MPSBEEG and MPDBEEG were comparable in TES on General Health Perception ( GHP ) at week 4 ; and GHP and Physical Functioning at week 8 respectively ( p > 0.05 ) .
RESULTS	However , MPDEEG had significantly higher TES in the other domains of the SF-36 ( p = 0.001 ) .
CONCLUSIONS	HRQoL in patients with LMLBP decreases with pain severity .
CONCLUSIONS	Each of MP , static and dynamic back extensors endurance exercises significantly improved HRQoL in LMLBP .
CONCLUSIONS	However , the addition of dynamic back extensors endurance exercise to MP led to greater improvement in HRQoL .

###24297949
OBJECTIVE	High-grade prostatic intraepithelial neoplasia ( HGPIN ) is considered a precursor lesion of prostate cancer ( PCa ) .
OBJECTIVE	The predictive value of ERG gene fusion in HGPIN for PCa was interrogated as a post hoc analysis in the context of a randomized clinical trial .
METHODS	The GTx Protocol G300104 randomly assigned 1,590 men with biopsy-diagnosed HGPIN to receive toremifene or placebo for 3 years or until a diagnosis of PCa was made on prostate biopsy .
METHODS	As part of this phase III clinical trial , a central pathologist evaluated biopsies of patients with isolated HGPIN at baseline and 12 , 24 , and 36 months of follow-up .
METHODS	ERG immunohistochemistry was performed on biopsies from 461 patients and evaluated for protein overexpression .
RESULTS	ERG expression was detected in 11.1 % of patients ( 51 of 461 patients ) with isolated HGPIN .
RESULTS	In the first year and during the 3-year clinical trial , 14.7 % and 36.9 % of 461 patients were diagnosed with PCa , respectively .
RESULTS	Patients with ERG expression were more likely to develop PCa , with 27 ( 53 % ) of 51 ERG-positive and 143 ( 35 % ) of 410 ERG-negative patients experiencing progression to PCa ( P = .014 , Fisher 's exact test ) .
RESULTS	ERG expression was not associated with age , baseline PSA , Gleason score , or tumor volume .
CONCLUSIONS	This study underscores the necessity of more stringent follow-up for men with HGPIN that is also positive for ERG overexpression .
CONCLUSIONS	Clinicians should consider molecular characterization of HGPIN as a means to improve risk stratification .

###24676950
BACKGROUND	Limited disease knowledge is frequently the cause of disease-related anxiety in myocardial infarction patients .
BACKGROUND	The ability to communicate effectively serves multiple purposes in the professional nursing practice .
BACKGROUND	By communicating effectively with myocardial infarction patients , nurses may help reduce their anxiety by keeping them well informed about their disease and teaching them self-care strategies .
OBJECTIVE	This research evaluates the communication skills of nurses following scenario-based simulation education in the context of communication with myocardial infarction patients .
METHODS	This study used an experimental design and an educational intervention .
METHODS	The target population comprised nurses of medicine ( clinical qualified level N to N2 for nursing ) working at a municipal hospital in Taipei City , Taiwan .
METHODS	A total 122 participants were enrolled .
METHODS	Stratified block randomization divided participants into an experimental group and a control group .
METHODS	The experimental group received clinical scenario-based simulation education for communication .
METHODS	The control group received traditional class-based education for communication .
METHODS	Both groups received a pre-test and a Communication Skills Checklist post-test assessment .
METHODS	Results were analyzed using SPSS 17.0 for Windows software .
RESULTS	A t-test showed significant increases in communication skills ( p < .001 ) in the experimental group and ANCOVA results identified significant between-group differences ( p < .001 ) in communication skills following the education intervention .
CONCLUSIONS	The results indicate that clinical scenario-based simulation education for communication is significantly more effective than traditional class-based education in enhancing the ability of nurses to communicate effectively with myocardial infarction patients .

###25854014
OBJECTIVE	To observe the effects on post-stroke depression treated with acupuncture at the acu points based on ziwuliuzhu ( the midnight-noon ebb-flow theory ) .
METHODS	Ninety-three patients were randomized into a comprehensive group , a ziwuliuzhu group and a prozac group , 31 cases in each group .
METHODS	In the ziwuliuzhu group , acupuncture was applied to the acupoints based on ziwuliuzhu , once a day , 5 times in a week .
METHODS	In the prozac group , fluoxertine hydrochloride ( prozac ) was prescribed for oral administration , once a day , 20 mg each time .
METHODS	In the comprehensive group , acupuncture based on ziwuliuzhu combined with the oral administration of prozac were adopted and the treatment frequency was the same as the ziwuliuzhu group and the prozac group .
METHODS	The 4-week treatment was taken as one session in the three groups and 6 sessions were required totally .
METHODS	The clinical efficacy and the Hamilton depression rating scale ( HAMD ) score and the adverse reaction were compared among the 3 groups .
RESULTS	The total effective rate was 96.8 % ( 30/31 ) in the comprehensive group , better than 83.9 % ( 26/31 ) in the ziwuliuzhu group and 80.6 % ( 25/31 ) in the prozac group ( both P < 0.05 ) .
RESULTS	In 4 , 12 and 24 weeks of treatment , HAMD score was lower significantly than that before the treatment in the three groups ( all P < 0.05 ) , and the score in the comprehensive group at each time point after treatment was lower than the other two groups ( all P < 0.05 ) .
RESULTS	In 4 and 12 weeks of treatment , there were not different significantly between the ziwuliuzhu group and the prozac group ( both P > 0.05 ) .
RESULTS	In 24 weeks of treatment , HAMD score in the ziwuliuzhu group was lower than that in the prozac group ( P < 0.05 ) .
RESULTS	For the adverse reaction , there were 2 cases in the comprehensive group , 6 cases in the prozac group and 0 case in the ziwzuliuzhu group .
CONCLUSIONS	The comprehensive therapy of acupuncture at the acupoints based on ziwuliuzhu and oral administration of prozac is superior to either the simple oral administration of prozac or the ziwuliuzhu acu-puncture in terms of clinical efficacy and the improvements in depressive state .
CONCLUSIONS	Regarding the clinical efficacy , the impact of simple ziwuliuzhu acupuncture is not different significantly as compared with the simple oral administration of prozac , but it is better than the simple oral administration of prozac in terms of the long-term HAMD score and safety .

###24956454
OBJECTIVE	A hardcopy or paper cognitive aid has been shown to improve performance during the management of simulated local anesthetic systemic toxicity ( LAST ) when given to the team leader .
OBJECTIVE	However , there remains room for improvement to ensure a system that can achieve perfect adherence to the published guidelines for LAST management .
OBJECTIVE	Recent research has shown that implementing a checklist via a designated reader may be of benefit .
OBJECTIVE	Accordingly , we sought to investigate the effect of an electronic decision support tool ( DST ) and designated `` Reader '' role on team performance during an in situ simulation of LAST .
METHODS	Participants were randomized to Reader + DST ( n = 16 , rDST ) and Control ( n = 15 , memory alone ) .
METHODS	The rDST group received the assistance of a dedicated Reader on the response team who was equipped with an electronic DST .
METHODS	The primary outcome measure was adherence to guidelines .
RESULTS	For overall and critical percent correct scores , the rDST group scored higher than Control ( 99.3 % vs 72.2 % , P < 0.0001 ; 99.5 % vs 70 % , P < 0.0001 , respectively ) .
RESULTS	In the LAST scenario , 0 ( 0 % ) of 15 in the control group performed 100 % of critical management steps , whereas 15 ( 93.8 % ) of 16 in the rDST group did so ( P < 0.0001 ) .
CONCLUSIONS	In a prospective , randomized single-blinded study , a designated Reader with an electronic DST improved adherence to guidelines in the management of an in situ simulation of LAST .
CONCLUSIONS	Such tools are promising in the future of medicine , but further research is needed to ensure the best methods for implementing them in the clinical arena .

###25317091
OBJECTIVE	To evaluate multiple doses of gabapentin 250 mg on polysomnography ( PSG ) and participant-reported sleep assessments in a 5-h phase advance insomnia model .
METHODS	Adults reporting occasional disturbed sleep received gabapentin 250 mg ( n = 128 ) or placebo ( n = 128 ) .
METHODS	On Days 1 and 28 , participants received medication 30 min before bedtime and were in bed from 17:00 to 01:00 , 5 h before their habitual bedtime .
METHODS	Sleep was assessed by PSG , a post sleep questionnaire , and the Karolinska Sleep Diary .
METHODS	Next-day residual effects and tolerability were evaluated .
METHODS	On Days 2-27 , participants took medication at home 30 min before their habitual bedtime .
RESULTS	Treatment-group demographics were comparable .
RESULTS	Gabapentin resulted in significantly less PSG wake after sleep onset ( WASO ) compared with placebo on Day 1 ( primary endpoint , mean : 107.0 versus 149.1 min , p 0.001 ) and Day 28 ( 113.6 versus 152.3 min , p = 0.002 ) , and significantly greater total sleep time ( TST ; Day 1 : 347.6 versus 283.9 min ; Day 28 : 335.3 versus 289.1 min ) ( p 0.001 ) .
RESULTS	Participant-reported WASO and TST also showed significant treatment effects on both days .
RESULTS	Gabapentin was associated with less % stage1 on Day 1 , and greater % REM on Day 28 , versus placebo .
RESULTS	During home use , gabapentin resulted in significantly less participant-reported WASO and higher ratings of sleep quality .
RESULTS	Gabapentin was well tolerated ( most common adverse events : headache , somnolence ) with no evidence of next-day impairment .
CONCLUSIONS	Gabapentin 250 mg resulted in greater PSG and participant-reported sleep duration following a 5-h phase advance on Day 1 and Day 28 of use without evidence of next-day impairment , and greater sleep duration during at-home use .

###25230735
BACKGROUND	Ageing populations may demand more blood transfusions , but the blood supply could be limited by difficulties in attracting and retaining a decreasing pool of younger donors .
BACKGROUND	One approach to increase blood supply is to collect blood more frequently from existing donors .
BACKGROUND	If more donations could be safely collected in this manner at marginal cost , then it would be of considerable benefit to blood services .
BACKGROUND	National Health Service ( NHS ) Blood and Transplant in England currently allows men to donate up to every 12 weeks and women to donate up to every 16 weeks .
BACKGROUND	In contrast , some other European countries allow donations as frequently as every 8 weeks for men and every 10 weeks for women .
BACKGROUND	The primary aim of the INTERVAL trial is to determine whether donation intervals can be safely and acceptably decreased to optimise blood supply whilst maintaining the health of donors .
METHODS	INTERVAL is a randomised trial of whole blood donors enrolled from all 25 static centres of NHS Blood and Transplant .
METHODS	Recruitment of about 50,000 male and female donors started in June 2012 and was completed in June 2014 .
METHODS	Men have been randomly assigned to standard 12-week versus 10-week versus 8-week inter-donation intervals , while women have been assigned to standard 16-week versus 14-week versus 12-week inter-donation intervals .
METHODS	Sex-specific comparisons will be made by intention-to-treat analysis of outcomes assessed after two years of intervention .
METHODS	The primary outcome is the number of blood donations made .
METHODS	A key secondary outcome is donor quality of life , assessed using the Short Form Health Survey .
METHODS	Additional secondary endpoints include the number of ` deferrals ' due to low haemoglobin ( and other factors ) , iron status , cognitive function , physical activity , and donor attitudes .
METHODS	A comprehensive health economic analysis will be undertaken .
CONCLUSIONS	The INTERVAL trial should yield novel information about the effect of inter-donation intervals on blood supply , acceptability , and donors ' physical and mental well-being .
CONCLUSIONS	The study will generate scientific evidence to help formulate blood collection policies in England and elsewhere .
BACKGROUND	Current Controlled Trials ISRCTN24760606 , 25 January 2012 .

###25366527
METHODS	A randomised crossover trial .
OBJECTIVE	To determine the effects of a 6-week standing programme on bowel function in people with spinal cord injury .
METHODS	Community , Australia and the United Kingdom .
METHODS	Twenty community-dwelling people with motor complete spinal cord injury above T8 participated in a 16-week trial .
METHODS	The trial consisted of a 6-week stand phase and a 6-week no-stand phase separated by a 4-week washout period .
METHODS	Participants were randomised to one of two treatment sequences .
METHODS	Participants allocated to the Treatment First group stood on a tilt table for 30min per session , five times per week for 6 weeks and then did not stand for the next 10 weeks .
METHODS	Participants allocated to the Control First group did the opposite : they did not stand for 10 weeks and then stood for 6 weeks .
METHODS	Participants in both groups received routine bowel care throughout the 16-week trial .
METHODS	Assessments occurred at weeks 0 , 7 , 10 and 17 corresponding with pre and post stand and no-stand phases .
METHODS	The primary outcome was Time to First Stool .
METHODS	There were seven secondary outcomes reflecting other aspects of bowel function and spasticity .
RESULTS	There were three dropouts leaving complete data sets on 17 participants .
RESULTS	The mean ( 95 % confidence interval ) between-intervention difference for Time to First Stool was 0min ( -7 to 7 ) indicating no effect of regular standing on Time to First Stool .
CONCLUSIONS	Regular standing does not reduce Time to First Stool .
CONCLUSIONS	Further trials are required to test the veracity of some commonly held assumptions about the benefits of regular standing for bowel function .

###24731467
OBJECTIVE	To explore the effects of phytoestrogen ( PE ) on blood lipid and bone density in postmenopausal women .
METHODS	A total of 75 menopausal women aged 50-70 years with estrogen reduction symptoms received an intake of soy protein containing 70 mg isoflavone daily in a year .
METHODS	Their changes of blood fat , density lumbar bone and sex hormone level were compared with control group without an intake .
RESULTS	The changes of blood triglyceride ( TG ) , total cholesterol ( TC ) and low-density lipoprotein ( LDL ) in two groups before and after a year showed no statistical significance.High-density lipoprotein ( HDL ) decreased in control group while it had no significant change in the study group .
RESULTS	Bone densities in two groups showed a downward trend by an annual rate of 1 % -4 % , the changes in two groups showed no statistical significance.E2 increased slightly over basic value in the study group .
RESULTS	But it had no statistical significance .
RESULTS	The changes of follicle-stimulating hormone ( FSH ) in two groups were also similar .
CONCLUSIONS	The above soy protein preparation has no effect on hypothalamic-pituitary-ovarian axis and no stimulation on endometrium of uterus .
CONCLUSIONS	But it may improve the profile of HDL .

###24888705
OBJECTIVE	To understand degeneration of healthy sites and identify factors associated with disease progression in patients with chronic periodontitis .
METHODS	Data on healthy sites from 163 American and Swedish subjects were analysed using two-three-state ( health , gingivitis , chronic periodontitis ) Markov models based on bleeding on probing ( BOP ) , and either clinical attachment level ( CAL ) + BOP or pocket depth ( PD ) + BOP .
RESULTS	In 2years , 10 % ( CAL+BOP ) and 3 % ( PD+BOP ) of healthy sites developed chronic periodontitis .
RESULTS	On average , healthy sites remained healthy for 32months before transiting in both models .
RESULTS	Most transitions ( 87-97 % ) from health were to the gingivitis state .
RESULTS	The expected duration of the gingivitis lesion was 4-5months and sites recovered with a high probability ( 96-98 % ) .
RESULTS	Disease severity as measured by number of sites with CAL/PD > 4mm at baseline and smoking , were associated with fast progression from health to chronic periodontitis within 6months as were gingival redness in the PD+BOP model only .
RESULTS	With age , the rate of disease progression to gingivitis decreased .
CONCLUSIONS	Transition probabilities for gingivitis and chronic periodontitis were higher with CAL+BOP than with PD+BOP .
CONCLUSIONS	Smoking and disease severity were significant predictors for fast progression .

###24968759
OBJECTIVE	To investigate changes in the pain-suppressing potency of 2 preoperatively applied topical nonsteroidal antiinflammatory drugs ( NSAIDs ) after photorefractive keratectomy ( PRK ) using a time-serial pain-scoring system .
METHODS	Saeyan Eye Center , Seoul , South Korea .
METHODS	Comparative case series .
METHODS	Ninety-four patients were randomly assigned to 2 groups : ketorolac group ( ketorolac 0.5 % in 1 eye and ofloxacin 0.3 % in the other eye ) and diclofenac group ( diclofenac 0.1 % in 1 eye and ofloxacin 0.3 % in the other eye ) .
METHODS	One drop of each ophthalmic drug was applied 3 times to each eye 30 minutes before PRK .
METHODS	No other NSAID or steroid was prescribed until 4 days after PRK .
METHODS	The patients were asked to score the postoperative pain in each eye with a visual analog scale at 6 , 18 , 24 , 36 , 48 , 72 , and 96 hours .
RESULTS	The natural peak of pain was located between 24 and 36 hours .
RESULTS	Initially , the degree of pain reduction was constant for both NSAIDs ; it dropped after 24 hours and 36 hours in the ketorolac group and the diclofenac group , respectively .
RESULTS	The postoperative time-serial pattern of the pain score changed in the diclofenac group but not in the ketorolac group compared with the pattern in the ofloxacin-treated eye .
RESULTS	The visual outcome was not affected by either NSAID , and significant complications were not noticed for a mean of 7 months .
CONCLUSIONS	The duration and pattern of the action may vary according to types of NSAIDs .
CONCLUSIONS	Preemptive topical diclofenac 0.1 % was a safe and effective method for post-PRK pain control .
BACKGROUND	No author has a financial or proprietary interest in any material or method mentioned .

###25311447
BACKGROUND	Lower levels of vitamin D are associated with increased MS risk and with greater clinical and brain MRI activity in established relapsing MS.
OBJECTIVE	The VIDAMS trial ( NCT01490502 ) is evaluating whether high-dose vitamin D supplementation reduces the risk of MS activity .
METHODS	Eligibility criteria include diagnosis of RRMS , age 18 to 50 years , and Expanded Disability Status Scale 4.0 .
METHODS	Disease duration and activity requirements depend on whether 2005 or 2010 criteria are used for diagnosis .
METHODS	Enrollment is restricted based on prior MS therapy exposure and recent vitamin D use .
METHODS	After completing a one-month run-in of glatiramer acetate , 172 patients will be randomized 1:1 to oral vitamin D ( 3 ) 5000 IU versus 600 IU daily .
METHODS	Clinical visits occur every 12 weeks for 96 weeks .
RESULTS	Sixteen sites throughout the United States are participating in the trial .
RESULTS	Complete enrollment is expected by late 2014 , with follow-up through 2016 .
RESULTS	No interim analyses are planned .
RESULTS	The primary outcome for the trial is the proportion of patients experiencing a relapse in each group .
RESULTS	Other clinical , patient-reported , and MRI outcomes will be evaluated .
CONCLUSIONS	The VIDAMS trial will provide critical information about the safety and efficacy of vitamin D therapy in RRMS , with implications for MS patients worldwide .

###24283391
OBJECTIVE	The present study aims to determine the efficiency and reliability of transcutaneous electrical nerve stimulation ( TENS ) in the management of pain related with uterine contractions after vaginal delivery and the pain related with both abdominal incision uterine contractions after cesarean section .
METHODS	A hundred healthy women who underwent cesarean section under general anesthesia were randomly assigned to the placebo group ( Group 1 ) or the TENS group ( Group 2 ) , while 100 women who delivered by vaginal route without episiotomy were randomized into the placebo group ( Group 3 ) or the TENS group ( Group 4 ) .
RESULTS	The patients in Group 2 had statistically lower visual analog scale ( VAS ) and verbal numerical scale ( VNS ) scores than the patients in Group 1 ( p < 0.001 for both ) .
RESULTS	The patients in Group 4 had statistically lower VAS and VNS scores than the patients in Group 3 ( p = 0.022 and p = 0.005 , respectively ) .
RESULTS	The analgesic requirement at the eighth hour of cesarean section was significantly lower in the patients who were treated with TENS ( p = 0.006 ) .
RESULTS	The need for analgesics at the eighth hour of vaginal delivery was statistically similar in the patients who were treated with TENS and the patients who received placebo ( p = 0.830 ) .
CONCLUSIONS	TENS is an effective , reliable , practical and easily available modality of treatment for postpartum pain .

###24708676
BACKGROUND	Childhood overweight has noticeable psychological and social consequences for the child and leads to an increased risk of mortality and morbidity later in life .
BACKGROUND	With the high prevalence of overweight in children and adolescents , it is important to identify effective approaches for the prevention and treatment of overweight in children and young individuals .
BACKGROUND	The primary aim of the study is to assess the effect of an intensive day-camp intervention on body mass index ( BMI ) in overweight children .
METHODS	The Odense Overweight Intervention Study is a semi-blinded randomized controlled trial .
METHODS	Overweight children from the Municipality of Odense , Denmark , were invited to participate in the trial .
METHODS	Based on power calculations 98 participants were found to be sufficient to randomize in order to find an effect of minimum 1.5 BMI points .
METHODS	Gender-stratified concealed block randomization with a ratio of 1:1 and random block sizes of two , four , and six ensured balance between study arms .
METHODS	The intervention consisted of a six-week multi-component day camp including increased physical activity , healthy diet and health education followed by 46weeks of family-based habitual intervention .
METHODS	The standard care arm was offered two weekly hours of physical activity training for six weeks .
METHODS	The outcomes were measured at baseline and at six-week and 52-week follow-ups .
METHODS	Furthermore , BMI will be assessed again at 48-month follow-up .
METHODS	Test personnel were kept blinded .
METHODS	The intervention effect will be evaluated using mixed model analyses .
METHODS	During 2012 and 2013 , 115 children were enrolled in the study .
METHODS	Fifty-nine children were randomized to the day-camp intervention arm and 56 to the standard intervention arm .
CONCLUSIONS	This study will provide novel information about the long-term health effects of an intense day-camp intervention program on overweight children , due to the design and the follow-up period .
CONCLUSIONS	Moreover , it will add to the knowledge on designing and implementing feasible camp settings for preventing overweight in children .
BACKGROUND	NCT01574352 at http://clinicaltrials.gov on the 8th of March 2012 .

###25252486
OBJECTIVE	To determine serum lipids in patients with age related macular degeneration from Pakistani population .
METHODS	The study was a cross sectional , randomized and case-control .
METHODS	Selected subjects ages were > or = 50 years and were normotensive , non-diabetic with no family history of any such disease and no complication of posterior ocular chamber other than age related macular degeneration ( AMD ) .
METHODS	Controls were age matched healthy individuals with no symptoms of AMD .
METHODS	Diagnosis of AMD was done through conventional diagnostic techniques by professional ophthalmologists .
METHODS	Serum samples were analyzed for total cholesterol , triglycerides , LDL and HDL using commercially available kits .
METHODS	Data were compared with Student 's t-test .
METHODS	Pearson correlation was calculated for relationship between different parameters .
METHODS	P < 0.05 was considered significant .
RESULTS	Compared to controls , AMD patients had significantly greater total cholesterol concentration ( p < 0.041 ) , and power HDL/LDL ratio ( p < 0.038 ) , while serum triglycerides , HDL and LDL were non-significantly different from control subjects .
RESULTS	Total cholesterol in AMD patients was significantly correlated with TG , LDL and HDL ( p < 0.0001 ) .
CONCLUSIONS	The study indicates that high cholesterol might be a predictor of AMD and can be a diagnostic parameter .

###24575949
BACKGROUND	Postoperative morbidity is a major disadvantage after oral and maxillofacial ( OMF ) surgery , often caused by pain , trismus and swelling affecting patients ' quality of life .
BACKGROUND	The goal of this study was to examine the effect of kinesiologic taping ( KT ) on swelling , pain , trismus and patients ' satisfaction after OMF surgery .
METHODS	Performing a pooled analysis of 96 patients that were assigned for maxillofacial treatment ( midface fractures n = 30 , mandibular fractures n = 26 , wisdom tooth removal n = 40 ) divided into treatment either with or without kinesiologic tape application .
METHODS	Tape was applied directly after surgery and maintained for at least 5 d postoperatively .
METHODS	Facial swelling was quantified at six specific points in time using a five-line measurement .
METHODS	Pain and degree of mouth opening was measured .
METHODS	Patients ' objective feeling and satisfaction was queried .
RESULTS	Application of KT after OMF surgery has a significant influence on the reduction of swelling decreasing the turgidity for 60 % during the first 2 d after surgery .
RESULTS	Evaluating all patients swelling was significantly lower in the KT treatment group ( T2 : 63.5 cm 4.3 ; T3 : 62.5 cm 4.2 ; T4 : 61.6 cm 4.2 ) than in the no-KT group ( T2 : 67.6 cm 5.0 ; T3 : 67.0 cm 5.0 ; T4 : 64.8 cm 4.8 ) at T2 ( p < 0.001 ) , T3 ( p < 0.001 ) , and T4 ( p = 0.001 ) .
RESULTS	VAS Pain values were scored significantly lower for the KT group ( T1 : 2.5 2.0 ( p = 0.006 ) ; T2 : 1.7 2.0 ( p < 0.001 ) ; T3 : 1.5 2.3 ( p = 0.004 ) ; T4 : 0.6 1.1 ( p = 0.001 ) compared to the no-KT group ( T1 : 3.8 2.5 ; T2 : 3.5 2.7 ; T3 : 2.9 2.2 ; T4 : 1.6 1.7 ) .
RESULTS	A statistically significant amelioration in mean mouth opening ability was observed in the KT group ( T1-BL : -0.08 cm 0.49 ( p = 0.025 ) ; T2-BL : 0.07 cm 0.59 ( p = 0.012 ) ; T3-BL : 0.20 0.63 ( p = 0.013 ) ; T4-BL : 0.42 0.59 ( p = 0.003 ) ) compared to the no-KT group ( T1-BL : -0.47 cm 0.86 ; T2-BL : -0.39 cm 0.84 ; T3-BL : -0.24 0.89 ; T4-BL : -0.13 1.02 ) .
CONCLUSIONS	KT after OMF surgery is a promising , simple , less traumatic , economical approach free from systemic adverse reaction upgrading patients ' quality of life .

###24881015
BACKGROUND	We examined the effectiveness of technical training ( TT ) and quiet eye training ( QE ) on the performance of one-handed square knot tying in surgical residents .
METHODS	Twenty surgical residents were randomly assigned to the 2 groups and completed pretest , training , retention , and transfer tests .
METHODS	Participants wore a mobile eye tracker that simultaneously recorded their gaze and hand movements .
METHODS	Dependent variables were knot tying performance ( % ) , QE duration ( % ) , number of fixations , total movement time ( s ) , and hand movement phase time ( s ) .
RESULTS	The QE training group had significantly higher performance scores , a longer QE duration , fewer fixations , faster total knot tying times , and faster movement phase times compared with the TT group .
RESULTS	The QE group maintained performance in the transfer test , whereas the TT group significantly decreased performance from retention to transfer .
CONCLUSIONS	QE training significantly improved learning , retention , and transfer of surgical knot tying compared with a traditional technical approach .
CONCLUSIONS	Both performance effectiveness ( performance outcome ) and movement efficiency ( hand movement times ) were improved using QE modeling , instruction , and feedback .

###25165427
BACKGROUND	Postoperative nausea and vomiting ( PONV ) is one of the most common postsurgical complications .
BACKGROUND	Palonosetron , a 5-hydroxytryptamine receptor antagonist , is effective for PONV prevention .
BACKGROUND	Herein , we compared palonosetron and aprepitant ( a neurokinin-1 receptor antagonist ) for PONV prevention in patients indicated for laparoscopic gynaecologic surgery .
METHODS	Ninety-three patients who were scheduled to undergo laparoscopic gynaecologic surgery under general anaesthesia were assigned to receive either a single intravenous injection of 0.075-mg palonosetron or 40-mg oral aprepitant in a double-blind randomised trial .
METHODS	The primary efficacy end points included complete response ( visual analogue scale [ VAS ] nausea score < 4 and no use of rescue therapy ) 0-48 h after surgery .
METHODS	Nausea severity ( 0-10 ) and use of rescue therapy were monitored for 0-48 h.
METHODS	The secondary efficacy end points were the effect of aprepitant quantified using a 10-point VAS for pain , consumption of intravenous patient-controlled analgesia , and use of rescue analgesics .
RESULTS	Aprepitant was non-inferior to palonosetron in terms of complete response 0-48 hours after surgery ( 74 % vs. 77 % ) .
RESULTS	At 0 and 2 h after administration , the nausea severity with 40-mg aprepitant was significantly lesser than that with 0.075-mg palonosetron ( P < 0.05 ) .
RESULTS	At 6 and 24 h after administration , fentanyl consumption with 40-mg aprepitant was significantly lower than that with 0.075-mg palonosetron .
RESULTS	Greater amounts of rescue analgesics were required in the aprepitant group .
CONCLUSIONS	Palonosetron and aprepitant were both effective for PONV prevention in the patients indicated for laparoscopic gynaecologic surgery .
CONCLUSIONS	The drugs can be used in combination for multimodal therapy because they bind to different receptors .
CONCLUSIONS	More research is needed to evaluate the effects of aprepitant on pain management in humans .

###25471753
BACKGROUND	The role that environmental factors , such as neighborhood socioeconomics , food , and physical environment , play in the risk of obesity and chronic diseases is not well quantified .
BACKGROUND	Understanding how spatial distribution of disease risk factors overlap with that of environmental ( contextual ) characteristics may inform health interventions and policies aimed at reducing the environment risk factors .
BACKGROUND	We evaluated the extent to which spatial clustering of extreme body mass index ( BMI ) values among a large sample of adults with diabetes was explained by individual characteristics and contextual factors .
METHODS	We quantified spatial clustering of BMI among 15,854 adults with diabetes from the Diabetes Study of Northern California ( DISTANCE ) cohort using the Global and Local Moran 's I spatial statistic .
METHODS	As a null model , we assessed the amount of clustering when BMI values were randomly assigned .
METHODS	To evaluate predictors of spatial clustering , we estimated two linear models to estimate BMI residuals .
METHODS	First we included individual factors ( demographic and socioeconomic characteristics ) .
METHODS	Then we added contextual factors ( neighborhood deprivation , food environment ) that may be associated with BMI .
METHODS	We assessed the amount of clustering that remained using BMI residuals .
RESULTS	Global Moran 's I indicated significant clustering of extreme BMI values ; however , after accounting for individual socioeconomic and demographic characteristics , there was no longer significant clustering .
RESULTS	Twelve percent of the sample clustered in extreme high or low BMI clusters , whereas , only 2.67 % of the sample was clustered when BMI values were randomly assigned .
RESULTS	After accounting for individual characteristics , we found clustering of 3.8 % while accounting for neighborhood characteristics resulted in 6.0 % clustering of BMI .
RESULTS	After additional adjustment of neighborhood characteristics , clustering was reduced to 3.4 % , effectively accounting for spatial clustering of BMI .
CONCLUSIONS	We found substantial clustering of extreme high and low BMI values in Northern California among adults with diabetes .
CONCLUSIONS	Individual characteristics explained somewhat more of clustering of the BMI values than did neighborhood characteristics .
CONCLUSIONS	These findings , although cross-sectional , may suggest that selection into neighborhoods as the primary explanation of why individuals with extreme BMI values live close to one another .
CONCLUSIONS	Further studies are needed to assess causes of extreme BMI clustering , and to identify any community level role to influence behavior change .

###25546420
BACKGROUND	Monoclonal antibodies ( mAbs ) which potently neutralize a broad range of HIV isolates are potential microbicide candidates .
BACKGROUND	To date , topical application of mAbs in humans and their stability in vaginal secretions has not been studied .
OBJECTIVE	To assess the pharmacokinetics and safety of the mAbs 2F5 , 4E10 and 2G12 when applied vaginally in women .
METHODS	A randomized , double-blind , placebo-controlled phase 1 trial .
METHODS	Twenty-eight healthy , sexually abstinent women administered 2.5 g of gel daily for 12 days containing either 10 or 20 mg/g of each mAb ( MABGEL ) or placebo .
METHODS	Main clinical evaluations and sampling occurred at baseline , 1 , 8 , and 24 hours post-1st dose and 12 and 36 hours post-12th dose .
RESULTS	After adjustment for dilution factors , median levels of 2F5 , 4E10 and 2G12 in vaginal secretions at 1 hour post high-dose MABGEL were 7.74 , 5.28 and 7.48 mg/ml respectively .
RESULTS	Levels of 2F5 and 4E10 declined exponentially thereafter with similar estimated half-lives ( 4.6 and 4.3 hours ) .
RESULTS	In contrast , 2G12 levels declined more rapidly in the first 8 hours , with an estimated half-life of 1.4 hours during this period .
RESULTS	There was no evidence of systemic absorption .
RESULTS	There were no significant differences in local or systemic adverse event rates or vaginal flora changes ( by qPCR ) between active and placebo gel arms .
RESULTS	Whilst at least 1 adverse event was recorded in 96 % of participants , 95 % were mild and none were serious .
CONCLUSIONS	Vaginal application of 50 mg of each mAb daily was safe over a 12 day period .
CONCLUSIONS	Median mAb concentrations detected at 8 hours post dose were potentially sufficient to block HIV transmission .2 G12 exhibited more rapid elimination from the human vagina than 4E10 and 2F5 , likely due to poor stability of 2G12 in acidic human vaginal secretions .
CONCLUSIONS	Further research is needed to develop mAb-based vaginal microbicides and delivery systems .
BACKGROUND	ISRCTN 64808733 UK CRN Portfolio 6470 .

###24549548
OBJECTIVE	Agitation is common , persistent , and associated with adverse consequences for patients with Alzheimer disease .
OBJECTIVE	Pharmacological treatment options , including antipsychotics are not satisfactory .
OBJECTIVE	The primary objective was to evaluate the efficacy of citalopram for agitation in patients with Alzheimer disease .
OBJECTIVE	Key secondary objectives examined effects of citalopram on function , caregiver distress , safety , cognitive safety , and tolerability .
METHODS	The Citalopram for Agitation in Alzheimer Disease Study ( CitAD ) was a randomized , placebo-controlled , double-blind , parallel group trial that enrolled 186 patients with probable Alzheimer disease and clinically significant agitation from 8 academic centers in the United States and Canada from August 2009 to January 2013 .
METHODS	Participants ( n = 186 ) were randomized to receive a psychosocial intervention plus either citalopram ( n = 94 ) or placebo ( n = 92 ) for 9 weeks .
METHODS	Dosage began at 10 mg per day with planned titration to 30 mg per day over 3 weeks based on response and tolerability .
METHODS	Primary outcome measures were based on scores from the 18-point Neurobehavioral Rating Scale agitation subscale ( NBRS-A ) and the modified Alzheimer Disease Cooperative Study-Clinical Global Impression of Change ( mADCS-CGIC ) .
METHODS	Other outcomes were based on scores from the Cohen-Mansfield Agitation Inventory ( CMAI ) and the Neuropsychiatric Inventory ( NPI ) , ability to complete activities of daily living ( ADLs ) , caregiver distress , cognitive safety ( based on scores from the 30-point Mini Mental State Examination [ MMSE ] ) , and adverse events .
RESULTS	Participants who received citalopram showed significant improvement compared with those who received placebo on both primary outcome measures .
RESULTS	The NBRS-A estimated treatment difference at week 9 ( citalopram minus placebo ) was -0.93 ( 95 % CI , -1.80 to -0.06 ) , P = .04 .
RESULTS	Results from the mADCS-CGIC showed 40 % of citalopram participants having moderate or marked improvement from baseline compared with 26 % of placebo recipients , with estimated treatment effect ( odds ratio [ OR ] of being at or better than a given CGIC category ) of 2.13 ( 95 % CI , 1.23-3 .69 ) , P = .01 .
RESULTS	Participants who received citalopram showed significant improvement on the CMAI , total NPI , and caregiver distress scores but not on the NPI agitation subscale , ADLs , or in less use of rescue lorazepam .
RESULTS	Worsening of cognition ( -1.05 points ; 95 % CI , -1.97 to -0.13 ; P = .03 ) and QT interval prolongation ( 18.1 ms ; 95 % CI , 6.1-30 .1 ; P = .01 ) were seen in the citalopram group .
CONCLUSIONS	Among patients with probable Alzheimer disease and agitation who were receiving psychosocial intervention , the addition of citalopram compared with placebo significantly reduced agitation and caregiver distress ; however , cognitive and cardiac adverse effects of citalopram may limit its practical application at the dosage of 30 mg per day .
BACKGROUND	clinicaltrials.gov Identifier : NCT00898807 .

###25833778
BACKGROUND	Oxidative stress plays an essential role in the pathogenesis of type 2 diabetes .
BACKGROUND	Anthocyanin , a natural antioxidant , has been reported to reduce oxidative stress and to attenuate insulin resistance and diabetes in animal models ; however , the translation of these observations to humans has not been fully tested .
OBJECTIVE	This study was designed to investigate the effects of purified anthocyanins on dyslipidemia , oxidative status , and insulin sensitivity in patients with type 2 diabetes .
METHODS	A total of 58 diabetic patients were given 160 mg of anthocyanins twice daily or placebo ( n = 29/group ) for 24 wk in a randomized , placebo-controlled , double-blind trial .
METHODS	Participants and investigators were masked to treatment allocation .
RESULTS	Anthocyanin supplementation significantly decreased serum LDL cholesterol ( by 7.9 % ; P < 0.05 ) , triglycerides ( by 23.0 % ; P < 0.01 ) , apolipoprotein ( apo ) B-48 ( by 16.5 % ; P < 0.05 ) , and apo C-III ( by 11.0 % ; P < 0.01 ) and increased HDL cholesterol ( by 19.4 % ; P < 0.05 ) compared with placebo after the 24-wk intervention .
RESULTS	In addition , patients in the anthocyanin group showed higher total radical-trapping antioxidant parameter and ferric ion reducing antioxidant power values than did patients in the placebo group ( both P < 0.05 ) .
RESULTS	Serum concentrations of 8-iso-prostaglandin F2 , 13-hydroxyoctadecadienoic acid , and carbonylated proteins in patients in the anthocyanin group were significantly less than in patients in the placebo group ( 23.4 % , 25.8 % ; P < 0.01 and 20 % ; P = 0.022 , respectively ) .
RESULTS	Furthermore , supplementation with anthocyanin lowered fasting plasma glucose ( by 8.5 % ; P < 0.05 ) and homeostasis model assessment for insulin resistance index ( by 13 % ; P < 0.05 ) , and elevated serum adiponectin ( by 23.4 % ; P < 0.01 ) and - hydroxybutyrate ( by 42.4 % ; P = 0.01 ) concentrations compared with placebo supplementation .
CONCLUSIONS	These findings demonstrate that anthocyanin supplementation exerts beneficial metabolic effects in subjects with type 2 diabetes by improving dyslipidemia , enhancing antioxidant capacity , and preventing insulin resistance .
CONCLUSIONS	This trial was registered at www.clinicaltrials.gov as NCT02317211 .

###25344395
BACKGROUND	Our aim was to evaluate the safety and efficacy of a low-intensity resistance training program combined with partial blow flow restriction ( BFR training ) in a cohort of patients with polymyositis ( PM ) and dermatomyositis ( DM ) .
METHODS	In total , 13 patients with PM and DM completed a 12-week twice a week low-intensity ( that is , 30 % one-repetition-maximum ( 1RM ) ) resistance exercise training program combined with partial blood flow restriction ( BFR ) .
METHODS	Assessments of muscle strength , physical function , quadriceps cross sectional ( CSA ) area , health-related quality of life , and clinical and laboratory parameters were assessed at baseline and after the intervention .
RESULTS	The BFR training program was effective in increasing the maximal dynamic strength in both the leg-press ( 19.6 % , P < 0.001 ) and knee-extension exercises ( 25.2 % P < 0.001 ) , as well as in the timed-stands ( 15.1 % , P < 0.001 ) and timed-up-and-go test ( -4.5 % , P = 0.002 ) .
RESULTS	Quadriceps CSA was also significantly increased after the intervention ( 4.57 % , P = 0.01 ) .
RESULTS	Similarly , all of the components of the Short Form-36 Health Survey , the Health Assessment Questionnaire scores , and the patient - and physician reported Visual Analogue Scale were significantly improved after training ( P < 0.05 ) .
RESULTS	Importantly , no clinical evidence or any other self-reported adverse event were found .
RESULTS	Laboratory parameters ( creatine kinase and aldolase ) were also unchanged ( P > 0.05 ) after the intervention .
CONCLUSIONS	We demonstrated that a 12-week supervised low-intensity resistance training program associated with partial blood flow restriction may be safe and effective in improving muscle strength and function as well as muscle mass and health-related quality of life in patients with PM and DM .
BACKGROUND	Clinicaltrials.gov NCT01501019 .
BACKGROUND	Registered November 29 , 2011 .

###24747978
OBJECTIVE	The aim of this hypothesis-generating pilot study was to assess prospectively the objective and subjective effects of treatment with quetiapine XR on sleep during early recovery from alcohol dependence ( AD ) .
METHODS	Recovering subjects with AD and sleep disturbance complaints were treated with quetiapine XR ( n = 10 ) or matching placebo pills ( n = 10 ) for 8 weeks .
METHODS	Polysomnography was used to assess sleep objectively , and the Insomnia Severity Index and Pittsburgh Sleep Quality Index were used to measure subjective insomnia .
METHODS	Other assessment measures included the 10-minute psychomotor vigilance task ( for neurobehavioral functioning ) , the time-line follow-back measure ( for alcohol consumption ) , the Penn Alcohol Craving Scale ( for alcohol craving ) , the Patient Health Questionnaire-9 item scale ( for depressive symptoms ) , and the Beck Anxiety Inventory ( for anxiety symptoms ) .
RESULTS	Although there was no effect of quetiapine XR on sleep efficiency ( time spent asleep/total recording time ) , there was a pre-to-post reduction in wake after sleep onset time ( P = 0.03 ) and nonsignificant trends for increases in sleep onset latency ( SOL ) and stage 2 sleep time .
RESULTS	A time drug interaction was seen for the subjective insomnia , such that quetiapine XR-treated subjects reported greater initial improvement in their subjective insomnia , but the difference was not sustained .
RESULTS	There were no differences between treatment groups on other measures or medication compliance .
CONCLUSIONS	Quetiapine XR improves objective sleep continuity and transiently improves subjective insomnia early in recovery from AD .

###24564252
BACKGROUND	Loss of phosphatase and tensin homologue ( PTEN ) function evaluated by loss of PTEN protein expression on immunohistochemistry ( IHC ) has been reported as both prognostic in metastatic colorectal cancer and predictive of response to anti-EGFR monoclonal antibodies although results remain uncertain .
BACKGROUND	Difficulties in the methodological assessment of PTEN are likely to be a major contributor to recent conflicting results .
METHODS	We assessed loss of PTEN function in 51 colorectal cancer specimens using Taqman copy number variation ( CNV ) and IHC .
METHODS	Two blinded pathologists performed independent IHC assessment on each specimen and inter-observer variability of IHC assessment and concordance of IHC versus Taqman CNV was assessed .
RESULTS	Concordance between pathologists ( PTEN loss vs no loss ) on IHC assessment was 37/51 ( 73 % ) .
RESULTS	In specimens with concordant IHC assessment , concordance between IHC and Taqman copy number in PTEN loss assessment was 25/37 ( 68 % ) .
CONCLUSIONS	Assessment PTEN loss in colorectal cancer is limited by the inter-observer variability of IHC , and discordance of CNV with loss of protein expression .
CONCLUSIONS	An understanding of the genetic mechanisms of PTEN loss and implementation of improved and standardized methodologies of PTEN assessment are required to clarify the role of PTEN as a biomarker in colorectal cancer .

###25573347
OBJECTIVE	This study was designed to investigate whether garlic powder tablets in adjunct to conventional medical treatment could have an effect on carotid intima-media thickness ( CIMT ) and plasma lipoproteins and lipids in patients with coronary artery disease ( CAD ) .
METHODS	A randomized , placebo-controlled , clinical trial was conducted on 56 patients with CAD between the ages of 25 and 75 years .
METHODS	The patients were randomly divided into two groups : garlic group ( n = 27 ) , receiving garlic powder tablet ( 1200 g allicin/tab ) twice daily and the placebo group ( n = 29 ) , receiving placebo for 3 months .
METHODS	The rate of atherosclerosis progression was measured by B-mode ultrasonography as the increase in CIMT .
RESULTS	After 3 months of taking garlic tablets , CIMT values had minor variations ( 0.009 0.007 mm reduction from baseline ) , while in the placebo group , an increase in CIMT values was observed ( 0.04 0.01 mm increase from baseline ) .
RESULTS	After 3 months of treatment , mean CIMT difference from baseline was significantly differ between the two groups ( p < 0.001 ) .
RESULTS	Plasma lipids and lipoproteins ( total cholesterol , triglycerides , low-density lipoprotein cholesterol , high-density lipoprotein cholesterol , Apolipoprotein A1 and Apolipoprotein B ) did not differ between the two groups .
CONCLUSIONS	The results suggest that dry garlic powder tablet is superior to placebo in prevention of CIMT progression in patients with CAD and may be considered as an adjunct treatment for atherosclerosis .

###24356755
BACKGROUND	Sedation or anaesthesia is recommended for all patients undergoing bronchoscopy unless absolute contraindications exist .
BACKGROUND	However , the widely used combination of propofol and opiates for moderate sedation ( MS ) in bronchoscopy results in a high incidence of hypoxaemia and a relatively high cough score during the procedure .
BACKGROUND	In this study , we evaluated the efficacy and safety of target-controlled infusion ( TCI ) of propofol and remifentanil , together with the use of high frequency jet ventilation ( HFJV ) , to achieve general anesthesia ( GA ) in diagnostic fibre-optic bronchoscopy .
METHODS	A total of 92 consecutive patients scheduled for flexible bronchoscopy were randomly assigned to receive either MS using TCI-delivered propofol and remifentanil ( n = 46 ) , or GA using TCI-delivered propofol and remifentanil with HFJV ( n = 46 ) .
METHODS	The following were compared between the MS and GA groups : incidence of hypoxaemia , cough score , haemodynamic parameters , partial pressure of carbon dioxide in arterial blood , duration of bronchoscopy and patient satisfaction score .
RESULTS	The average and minimum oxygen saturation values in the MS group were lower than those in the GA group .
RESULTS	The MS group showed a higher incidence of hypoxaemia .
RESULTS	There was no significant difference in the partial pressure of carbon dioxide between the two groups .
RESULTS	Cough score and duration of the bronchoscopy were markedly lower in the GA group , and patient satisfaction score was higher in the GA group .
CONCLUSIONS	GA , achieved via TCI-delivered propofol and remifentanil with HFJV , provides better conditions for diagnostic bronchoscopy - it decreases the occurrence of hypoxaemia , shortens the duration of bronchoscopy and increases patient satisfaction .

###24521531
OBJECTIVE	Prescription drug abuse has reached epidemic proportions .
OBJECTIVE	Nonmedical prescription opioid use carries increasingly high costs .
OBJECTIVE	Despite the need to cultivate efforts that are both effective and fiscally responsible , the cost-effectiveness of universal evidence-based-preventive-interventions ( EBPIs ) is rarely evaluated .
OBJECTIVE	This study explores the performance of these programs to reduce nonmedical prescription opioid use .
METHODS	Sixth graders from twenty-eight rural public school districts in Iowa and Pennsylvania were blocked by size and geographic location and then randomly assigned to experimental or control conditions ( 2002-2010 ) .
METHODS	Within the intervention communities , prevention teams selected a universal family and school program from a menu of EBPIs .
METHODS	All families were offered a family-based program in the 6th grade and received one of three school-based programs in 7th-grade .
METHODS	The effectiveness and cost-effectiveness of each school program by itself and with an additional family-based program were assessed using propensity and marginal structural models .
RESULTS	This work demonstrates that universal school-based EBPIs can efficiently reduce nonmedical prescription opioid use .
RESULTS	Further , findings illustrate that family-based programs may be used to enhance the cost-effectiveness of school-based programs .
CONCLUSIONS	Universal EBPIs can effectively and efficiently reduce nonmedical prescription opioid use .
CONCLUSIONS	These programs should be further considered when developing comprehensive responses to this growing national crisis .

###24431895
OBJECTIVE	To examine the efficacy of telbivudine ( LdT ) + adefovir ( ADV ) vs continuation of lamivudine ( LAM ) + ADV in patients with LAM-resistant chronic hepatitis B ( CHB ) who show a suboptimal response to LAM + ADV.
METHODS	This was a randomized , active-control , open-label , single-center , parallel trial .
METHODS	All eligible patients were enrolled in this study in Severance Hospital , Yonsei University College of Medicine , Seoul , South Korea , between March 2010 and March 2011 .
METHODS	Hepatitis Be antigen ( HBeAg ) - positive CHB patients whose serum hepatitis B virus ( HBV ) DNA remained detectable despite at least 6 mo of LAM + ADV therapy were included .
METHODS	Enrolled patients were randomized to either switching to LdT ( 600 mg/d orally ) plus ADV ( 10 mg/d orally ) ( LdT + ADV group ) or to continuation with LAM ( 100 mg/d orally ) plus ADV ( 10 mg/d orally ) ( LAM + ADV group ) , and were followed for 48 wk .
METHODS	One hundred and six patients completed the 48-wk treatment period .
METHODS	Serum HBV DNA , HBeAg status , liver biochemistry and safety were monitored at baseline and week 12 , 24 , 36 and 48 .
RESULTS	The duration of prior LAM + ADV treatment was 18.3 ( LdT + ADV ) and 14.9 mo ( LAM + ADV ) , respectively ( P = 0.131 ) .
RESULTS	No difference was seen in baseline serum HBV DNA between the two groups [ 3.66 ( LdT + ADV ) vs 3.76 ( LAM + ADV ) log10 IU/mL , P = 0.729 ] .
RESULTS	At week 48 , although there was no significant difference in the mean reduction of serum HBV DNA from baseline between LdT + ADV group and LAM + ADV group ( -0.81 vs -0.47 log10 IU/mL , P = 0.167 ) , more patients in the LdT + ADV group had undetectable HBV DNA levels compared to those in the LAM + ADV group ( 30.2 % vs 11.5 % , P = 0.019 ) .
RESULTS	Three patients with LdT + ADV treatment and 2 patients with LAM + ADV treatment achieved HBeAg loss .
RESULTS	The patients in both groups tolerated the treatment well without serious adverse events .
RESULTS	The proportion of patients with estimated glomerular filtration rate 90 mL/min per 1.73 m ( 2 ) in the LdT + ADV group increased from 49.1 % ( 26/53 ) at baseline to 58.5 % ( 31/53 ) at week 48 , while that in the LAM + ADV group decreased from 37.7 % ( 20/53 ) at baseline to 30.2 % ( 16/53 ) at week 48 .
CONCLUSIONS	The switch to LdT + ADV in suboptimal responders to LAM + ADV showed a significantly higher rate of virologic response at week 48 .
CONCLUSIONS	These results suggest that LdT + ADV could be a therapeutic option for patients who are unable to use enofovir disoproxil fumarate for any reason .

###25335375
BACKGROUND	The objective of this study was to assess the influence of lingual bar and lingual plate major connectors on plaque retention and gingival health among patients who presented in University College Hospital ( UCH ) , Ibadan , Nigeria .
METHODS	This comparative intervention study was carried out among fifteen patients aged 28 to 60 years with Kennedy class III lower edentulous arch .
METHODS	Two metal dentures with different major connector designs ( lingual plate and lingual bar ) were fabricated for each patient .
METHODS	After professional scaling and polishing , a baseline score of the oral hygiene was done using the plaque index of Sillness and Loe and the gingival health using the gingival index of Loe and Sillness .
METHODS	Each patient was randomly assigned either a denture with the plate or bar design to use for three months and then recalled for reassessment of oral hygiene and gingival health .
METHODS	Professional scaling and polishing was done post removal and a new baseline assessment of oral hygiene and gingival health recorded .
METHODS	The dentures were now exchanged and the second major connector design inserted .
METHODS	Each patient was recalled for reassessment of the oral hygiene and gingival health after three months .
METHODS	The level of plaque accumulation and gingival inflammation with the use of lingual plate and bar dentures were determined and compared .
RESULTS	There was no statistically significant difference in the mean plaque index score for the lingual bar design at three months and the mean plaque index score at three months for the lingual plate ( p > 0.05 ) .
RESULTS	However , a statistically significant lower mean gingival index score was noted three months post insertion for lingual bar designs when compared to plate designs .
CONCLUSIONS	Within the limitation of this study , better gingival health was noted with the bar designs when compared with the plate designs .

###24804364
OBJECTIVE	We evaluated the effect of an educational intervention administered to patients or/and physicians on the reduction in HbA ( 1c ) and achieving diabetic control in a high-risk primarily Black inner-city population .
METHODS	The study was designed as a four-arm randomized clinical trial where an educational program on diabetes was offered to physicians only , patients only , and both physicians and their patients , while the fourth arm did not receive any instruction .
METHODS	We built regression models at 24 months of follow-up to assess the likelihood of reaching glycemic goal as well as to measure the absolute reduction in HbA ( 1c ) controlling for arm assignment , insulin use , race , age , sex , smoking , insulin use , and having achieved blood pressure control .
RESULTS	Between April 2005 and July 2007 , there were 823 patients randomized into the study .
RESULTS	In multivariate analyses , the intervention group in which only patients received education showed a trend toward achieving a significant mean reduction in HbA ( 1c ) with 49 % ( P = .06 ) higher odds of reaching glycemic control and .12 ( P = .06 ) greater absolute percentage point drop in HbA ( 1c ) compared to the no education group .
CONCLUSIONS	Although our study reports positive results , it warrants a special emphasis on the behavior of the patient .
CONCLUSIONS	Study results bring attention to disease management programs such as peer support networks that empower the patients that shift some of the responsibility to them .

###25107530
BACKGROUND	Hepatitis B virus ( HBV ) is a vaccine preventable infection yet vaccination rates are low among injection drug users ( IDUs ) despite the high risk of infection and longstanding recommendations to promote vaccination .
BACKGROUND	We sought to improve vaccination rates by reaching IDUs through syringe exchange programs ( SEPs ) in three U.S. cities .
METHODS	IDUs were randomized in a trial comparing the standard HBV vaccination schedule ( 0 , 1 , and 6 months ) to an accelerated schedule ( 0 , 1 , and 2 months ) and participation data were analyzed to identify determinants of completion of the three-dose vaccine series .
METHODS	Independent variables explored included sociodemographics , injection and syringe access behaviors , assessment of health beliefs , HBV-associated knowledge , and personal health status .
RESULTS	Covariates associated with completion of the three-dose vaccine series were accelerated vaccine schedule ( aOR 1.92 , 95 % CI 1.34 , 2.58 , p = < 0.001 ) , older age ( aOR 1.05 , 95 % CI 1.03 , 1.07 , p = < 0.001 ) , and poorer self-rated health score ( aOR 1.26 , 95 % CI 1.05 , 1.5 , p = 0.02 ) .
RESULTS	Completion was less likely for those getting syringes from SEP customers than for SEP customers ( OR 0.33 , 95 % CI 0.19 , 0.58 , p = < 0.001 ) .
CONCLUSIONS	SEPs should offer hepatitis vaccination in a manner that minimizes time between first and last visits by accelerating the dosing schedule .
CONCLUSIONS	Public health interventions should target younger , less healthy , and non-SEP customer participants .
CONCLUSIONS	Other health interventions at SEPs may benefit from similar approaches that reach out beyond regular SEP customers .

###25203817
OBJECTIVE	To examine the effect of low-volume sprint interval training ( SIT ) on the development ( part 1 ) and subsequent maintenance ( part 2 ) of aerobic fitness in soccer players .
METHODS	In part 1 , 23 players from the same semiprofessional team participated in a 2-wk SIT intervention ( SIT , n = 14 , age 25 4 y , weight 77 8 kg ; control , n = 9 , age 27 6 y , weight 72 10 kg ) .
METHODS	The SIT group performed 6 training sessions of 4-6 maximal 30-s sprints , in replacement of regular aerobic training .
METHODS	The control group continued with their regular training .
METHODS	After this 2-wk intervention , the SIT group was allocated to either intervention ( n = 7 , 1 SIT session/wk as replacement of regular aerobic training ) or control ( n = 7 , regular aerobic training with no SIT sessions ) for a 5-wk period ( part 2 ) .
METHODS	Pre and post measures were the YoYo Intermittent Recovery Test Level 1 ( YYIRL1 ) and maximal oxygen uptake ( VO2max ) .
RESULTS	In part 1 , the 2-week SIT intervention had a small beneficial effect on YYIRL1 ( 17 % ; 90 % confidence limits 11 % ) , and VO2max ( 3.1 % ; 5.0 % ) compared with control .
RESULTS	In part 2 , 1 SIT session/wk for 5 wk had a small beneficial effect on VO2max ( 4.2 % ; 3.0 % ) , with an unclear effect on YYIRL1 ( 8 % ; 16 % ) .
CONCLUSIONS	Two weeks of SIT elicits small improvements in soccer players ' high-intensity intermittent-running performance and VO2max , therefore representing a worthwhile replacement of regular aerobic training .
CONCLUSIONS	The effectiveness of SIT for maintaining SIT-induced improvements in high-intensity intermittent running requires further research .

###24239451
OBJECTIVE	The objective of the study was to investigate the cerebrovascular hemodynamic response of cervical spine positions including rotation and cervical spine manipulation in vivo using magnetic resonance imaging technology on the vertebral artery ( VA ) .
METHODS	This pilot study was conducted as a blinded examiner cohort with 4 randomized clinical tasks .
METHODS	Ten healthy male participants aged 24 to 30 years ( mean , 26.8 years ) volunteered to participate in the study .
METHODS	None of the participants had a history of disabling neck , arm , or headache pain within the last 6 months .
METHODS	They did not have any current or history of neurologic symptoms .
METHODS	In a neutral head position , physiologic measures of VA blood flow and velocity at the C1-2 spinal level were obtained using phase-contrast magnetic resonance imaging after 3 different head positions and a chiropractic upper cervical spinal manipulation .
METHODS	A total of 30 flow-encoded phase-contrast images were collected over the cardiac cycle , in each of the 4 conditions , and were used to provide a blood flow profile for one complete cardiac cycle .
METHODS	Differences between flow ( in milliliters per second ) and velocity ( in centimeters per second ) variables were evaluated using repeated-measures analysis of variance .
RESULTS	The side-to-side difference between ipsilateral and contralateral VA velocities was not significant for either velocities ( P = .14 ) or flows ( P = .19 ) throughout the conditions .
RESULTS	There were no other interactions or trends toward a difference for any of the other blood flow or velocity variables .
CONCLUSIONS	There were no significant changes in blood flow or velocity in the vertebral arteries of healthy young male adults after various head positions and cervical spine manipulations .

###24379596
OBJECTIVE	To investigate effects of perirenal space blocking ( PSB ) on gastrointestinal function in patients with severe acute pancreatitis ( SAP ) .
METHODS	Forty patients with SAP were randomly allocated to receive PSB or no PSB ( NPSB ) .
METHODS	All the SAP patients received specialized medical therapy ( SMT ) .
METHODS	Patients in the PSB group received PSB + SMT when hospitalized and after diagnosis , whereas patients in the NPSB group only received SMT .
METHODS	A modied gastrointestinal failure ( GIF ) scoring system was used to assess the gastrointestinal function in SAP patients after admission .
METHODS	Pain severity ( visual analog scale , 0 to 100 ) was monitored every 24 h for 72 h.
RESULTS	Modified GIF score decreased in both groups during the 10-d study period .
RESULTS	The median score decrease was initially significantly greater in the PSB group than in the NPSB group after PSB was performed .
RESULTS	During the 72-h study period , pain intensity decreased in both groups .
RESULTS	The median pain decrease was significantly greater in the PSB group than in the NPSB group at single time points .
RESULTS	Patients in the PSB group had significantly lower incidences of hospital mortality , multiple organ dysfunction syndrome , systemic inflammatory response syndrome , and pancreatic infection , and stayed in the intensive care unit for a shorter duration .
RESULTS	However , no difference in terms of operation incidence was found between the two groups .
CONCLUSIONS	PSB could ameliorate gastrointestinal dysfunction or failure during the early stage of SAP .
CONCLUSIONS	Moreover , PSB administration could improve prognosis and decrease the mortality of SAP patients .

###24440643
OBJECTIVE	To examine the effect of a 12-week Tai Chi ( TC ) intervention on physical function and quality of life .
METHODS	Single-blind , randomized controlled trial .
METHODS	General community .
METHODS	Community-dwelling survivors of stroke ( N = 145 ; 47 % women ; mean age , 70y ; time poststroke : 3y ; ischemic stroke : 66 % ; hemiparesis : 73 % ) who were aged 50 years and were 3 months poststroke .
METHODS	Yang style 24-posture short-form TC ( n = 53 ) , strength and range of movement exercises ( SS ) ( n = 44 ) , or usual care ( UC ) ( n = 48 ) for 12 weeks .
METHODS	The TC and SS groups attended a 1-hour class 3 times per week , whereas the UC group had weekly phone calls .
METHODS	Physical function : Short Physical Performance Battery , fall rates , and 2-minute step test ; quality of life : Medical Outcomes Study 36-Item Short-Form Health Survey , Center for Epidemiologic Studies Depression Scale , and Pittsburgh Sleep Quality Index .
RESULTS	During the intervention , TC participants had two thirds fewer falls ( 5 falls ) than the SS ( 14 falls ) and UC ( 15 falls ) groups ( ( 2 ) = 5.6 , P = .06 ) .
RESULTS	There was a significant group by time interaction for the 2-minute step test ( F2 ,142 = 4.69 , P < .01 ) .
RESULTS	Post hoc tests indicated that the TC ( t53 = 2.45 , P = .02 ) and SS ( t44 = 4.63 , P < .01 ) groups had significantly better aerobic endurance over time , though not in the UC group ( t48 = 1.58 , P = .12 ) .
RESULTS	Intervention adherence rates were 85 % .
CONCLUSIONS	TC and SS led to improved aerobic endurance , and both are suitable community-based programs that may aid in stroke recovery and community reintegration .
CONCLUSIONS	Our data suggest that a 12-week TC intervention was more effective in reducing fall rates than SS or UC interventions .
CONCLUSIONS	Future studies examining the effectiveness of TC as a fall prevention strategy for community-dwelling survivors of stroke are recommended .

###24842181
BACKGROUND	In this prospective , randomized , observer-blinded study , we compared double-injection ( DI ) ultrasound-guided supraclavicular block to a novel targeted intracluster-injection ( TII ) technique , whereby local anesthetic is injected inside the main and satellite neural clusters ( confluences of trunks and divisions of the brachial plexus ) .
METHODS	Ninety patients were randomly allocated to receive a DI ( n = 45 ) or TII ( n = 45 ) technique for ultrasound-guided supraclavicular block .
METHODS	The local anesthetic drug ( lidocaine 1.5 % with epinephrine 5 g/mL ) and total volume ( 32 mL ) were identical in all subjects .
METHODS	In both groups , half the volume ( 16 mL ) was injected inside the main neural cluster .
METHODS	For the DI technique , the second half ( 16 mL ) was deposited at the `` corner pocket '' ( intersection of the first rib and subclavian artery ) .
METHODS	In contrast , for the TII technique , the remaining half was divided into equal aliquots and injected inside every single satellite cluster .
METHODS	The main outcome variable was the total anesthesia-related time ( sum of performance and onset times ) .
RESULTS	Due to a quicker onset ( mean standard deviation ( SD ) : 10.1 6.4 vs 18.5 8.3 minutes ; P < 0.0001 ) , the total anesthesia-related time was shorter with the TII technique ( 21.2 7.7 vs 27.7 9.0 minutes ; P = 0.001 ; 95 % confidence interval for the difference of the means : 2.90-10 .08 minutes ) .
RESULTS	There were 0 ( of 45 ) and 3 ( of 45 ) surgical failures for the TII and DI group , respectively .
RESULTS	Thus , the 2 methods achieved comparable rates of surgical anesthesia ( 93.3 % -100.0 % ; 95 % confidence interval for the difference of the success rates : -2.3 % to 17.9 % ) .
RESULTS	No intergroup differences were observed in block-related pain scores and adverse events .
RESULTS	The DI group required fewer needle passes ( median interquartile range : 4 2 vs 7 3 ; P < 0.0001 ) as well as shorter needling ( 8.4 2.9 vs 10.7 2.7 minutes ; P < 0.0001 ) and performance ( 9.0 3.2 vs 11.2 3.0 minutes ; P = 0.001 ) times .
CONCLUSIONS	Although DI and TII ultrasound-guided supraclavicular blocks seem to provide comparable success rates , we can not exclude the possibility that an intergroup difference of 17.9 % might have gone undetected .
CONCLUSIONS	Due to its quick onset , the TII technique results in a shorter total anesthesia-related time .

###24966145
OBJECTIVE	Objectively measure the ability of facial reanimation surgery to normalize the appearance of facial paralysis using eye-tracking technology .
METHODS	Prospective randomized controlled experiment .
METHODS	An eye-tracker system was used to record the eye-movement patterns , called scanpaths , of 86 nave observers gazing at pictures of paralyzed faces ( House-Brackmann IV-VI ) , smiling and in repose ; before and after facial reanimation surgery ; as well as normal , nonparalyzed faces .
METHODS	Observers gazed at each face for 10 seconds .
METHODS	Fixation durations for all predefined facial areas of interest were analyzed using mixed-effects linear regression .
RESULTS	Observers spent the majority of time ( 6.6 of 10 seconds ) gazing in the central triangle region ( eyes , nose , and mouth ) of normal faces and paralyzed faces .
RESULTS	There were significant deviations in fixation within the central triangle of paralyzed faces as compared to normal faces .
RESULTS	Total fixation on the eyes remained conserved .
RESULTS	However , total nose fixation decreased and mouth fixation increased on paralyzed faces .
RESULTS	Facial reanimation surgery normalized many of the hemifacial gaze asymmetries caused by unilateral facial paralysis , and restored a normal distribution of gaze between the functional and paralyzed sides of the face and mouth .
CONCLUSIONS	There were objective differences in the way observers directed their attention to facial features when viewing normal and paralyzed faces .
CONCLUSIONS	After facial reanimation surgery , the attentional distraction caused by facial feature irregularities was reduced .
CONCLUSIONS	These findings are important additions to the emerging body of objective evidence indicating the effectiveness of reanimation surgery ; they also suggest opportunities to optimize reconstruction .
METHODS	N/A .

###24829951
OBJECTIVE	Psychological interventions show greater efficacy when evaluated with distressed patients .
OBJECTIVE	We report on the feasibility of implementing screening for recruiting distressed cancer patients to a randomized controlled trial of problem-solving therapy ( PST ) , characteristics associated with enrolment , and time investment and challenges of implementing screening .
METHODS	Three medical settings implemented screening of patients , directly after cancer treatment ( T1 ) and 2 months later ( T2 ) , using Hopkins Symptom Checklist-25 and one question about need for services .
METHODS	Distressed patients indicating need for services were interviewed .
METHODS	Eligible patients were offered the possibility to participate in the trial .
METHODS	Consenting patients were randomized to PST or waitlist .
RESULTS	At T1 , 366 of 970 screened patients ( 37 % ) scored above the cutoff and at T2 , 208 of 689 screened patients ( 30 % ) .
RESULTS	At either or both T1 and T2 , 423 patients reported distress , of whom 215 indicated need for services .
RESULTS	Only 36 ( 4 % of 970 ) patients consented to trial participation .
RESULTS	Twenty-seven patients needed to be screened to recruit a single patient , with 17 h required for each patient recruited .
RESULTS	Barriers to screening were time constraints and negative attitudes of oncology staff towards screening .
CONCLUSIONS	Implementing screening proved inefficient for recruiting distressed cancer patients post-treatment to a randomized controlled trial on PST , with need for services being much less than anticipated .
CONCLUSIONS	Consecutively screening patients did not result in a sample representative of the larger pool of distressed patients , which may lower generalizability .
CONCLUSIONS	An adequately powered intervention trial using screening requires a feasibility study establishing recruitment rates and dedicated , funded staff assistance .

###24676694
OBJECTIVE	To compare the effects of combined oral contraceptives ( OCs ) containing cyproterone acetate and drospirenone in the treatment of polycystic ovary syndrome ( PCOS ) .
METHODS	Fifty-two patients with PCOS were randomized in two groups : group A ( n = 26 ) received 0.035 mg ethinyl estradiol + 2 mg cyproterone acetate and group B ( n = 26 ) received 0.03 mg ethinyl estradiol + 3 mg drospirenone-containing OCs for 12 months .
METHODS	Baseline clinical features including body mass index , waist to hip ratio ( WHR ) , and modified Ferriman-Gallwey ( mFG ) score were noted .
METHODS	Baseline biochemical parameters included androgen profile , carbohydrate metabolism , lipid profile , and oxidative stress .
METHODS	The percentages of changes for all parameters were compared .
RESULTS	The groups were comparable regarding the baseline characteristics .
RESULTS	WHR decreased significantly from baseline ( -4 % [ -31 to 35 ] ) in group B when compared to group A ( 0 % [ -11 to 14 ] ) ( P = 0.033 ) .
RESULTS	The total mFG score decreased significantly from baseline ( -35 % [ -71 to 10 ] ) in group A when compared to group B ( -18 % [ -72 to 30 ] ) ( P = 0.035 ) .
RESULTS	Changes in androgen hormone profile were comparable except DHEA-SO4 ( -32 % [ -53 to 15 ] in group B vs. -10 % [ -49 to 63 ] in group A ; P = 0.046 ) .
RESULTS	The effects of the drugs were similar regarding carbohydrate metabolism , lipid profile , and oxidative stress parameters .
CONCLUSIONS	Cyproterone acetate containing OCs seem to be more effective to treat clinical hirsutism in patients with PCOS after 12 months of treatment .

###25257667
BACKGROUND	It is often difficult to enrol healthy volunteers into a randomized controlled trial ( RCT ) as there are barriers to participants ' proper understanding of a trial .
BACKGROUND	This study aimed to evaluate degrees of understanding of the informed consent ( IC ) process among healthy volunteers who participated in an RCT .
BACKGROUND	Additionally , factors associated with degree of understanding were investigated .
METHODS	The J-START ( the Japan STrategic Anti-cancer Randomized controlled Trial ) is an RCT investigating the effectiveness of ultrasonography screening for breast cancer in women aged 40 to 49 years .
METHODS	To evaluate participants ' understanding of the J-START , we administered questionnaires to 376 Japanese women on the day of enrolment at five study sites across Japan .
METHODS	The respondents were asked to complete the anonymous questionnaire within 2 weeks .
METHODS	We assessed objective understanding and perceived subjective understanding of IC using a Japanese version of the Quality of Informed Consent scale ( QuIC ) .
METHODS	Then we analyzed the characteristics of women whose understanding was poor , and clarified the association between providing information and their understanding of the study protocol .
RESULTS	The average QuIC scores were 78.2 and 82.2 ( out of 100 each ) for objective and subjective understanding , respectively .
RESULTS	These are generally acceptable scores for participants ' understanding of an RCT .
RESULTS	However , there were four domains with low scores , indicating poor understanding : ( 1 ) experimental nature of the study , ( 2 ) potential risks or discomfort , ( 3 ) benefit to self , and ( 4 ) compensation .
CONCLUSIONS	Healthy volunteers generally well understood the J-START .
CONCLUSIONS	Nevertheless , there were some domains in need of improvement .
CONCLUSIONS	In order to facilitate participants ' understanding , it is necessary to provide training to reduce differences in information-providing procedures between medical centres and to endeavour to provide consistent information and conditions .
BACKGROUND	The J-START was registered with the University Hospital Medical Information Network Clinical Trial Registration ( UMIN-CTR ) , Japan ( registration number : UMIN000000757 ) , on July 1 , 2007 .

###25510446
OBJECTIVE	To determine the feasibility of using a 70-kVp protocol compared with a 120-kVp protocol for cerebral CT angiography .
OBJECTIVE	An additional target was to investigate a possible reduction in the volume of contrast medium ( CM ) using the 70-kVp protocol .
METHODS	Attenuation value and CNR for iodine were determined at various tube voltage settings using a phantom .
METHODS	Sixty-nine volunteers were randomly assigned to one of three protocols : group A ( 120-kVp and CM 64 mL ) , group B ( 70-kVp and CM 64 mL ) , or group C ( 70-kVp and CM 40 mL ) .
METHODS	The attenuation value , SNR , and CNR of cerebral arteries , subjective image quality , and radiation dose were compared among the groups .
RESULTS	The vascular attenuation , SNR , and CNR of group B were significantly higher than those of group A. Group C had a significantly higher vascular attenuation than group A. Groups B and C were significantly better than group A with respect to subjective image quality .
RESULTS	An effective dose of 70-kVp was 10 % lower than that of 120-kVp .
CONCLUSIONS	Using 70-kVp improved arterial enhancement , SNR , and CNR , and provided better subjective image quality , using a 10 % lower effective dose .
CONCLUSIONS	Furthermore , the 70-kVp protocol may both reduce volume of CM by 37.5 % and improve arterial enhancement .
CONCLUSIONS	Cerebral CT angiography at 70-kVp substantially improved vascular enhancement Subjective image quality was better at 70-kVp , with lower radiation dose The volume of contrast media can be substantially reduced at 70-kVp .

###25361829
OBJECTIVE	To better understand the implications of new-onset diabetes after transplant ( NODAT ) , we used our prospectively followed cohort of 628 adult primary kidney transplant recipients to determine the prognostic impact of pretransplant diabetes and NODAT .
METHODS	The study cohort consisted of all participants in four randomised immunosuppression trials performed at our centre since May 2000 .
METHODS	For each cause-specific hazard analysed , Cox stepwise regression was used to determine a multivariable model of significant baseline predictors ; the multivariable influence of having pretransplant diabetes and NODAT ( t ) ( the latter defined as a zero-one , time-dependent covariate ) was subsequently tested .
METHODS	Similar analyses of estimated glomerular filtration rate ( eGFR ) at 36 and 60 months post transplant were performed using stepwise linear regression .
METHODS	Finally , a repeated measures analysis of mean HbA1c as a function of diabetes category ( pretransplant diabetes vs NODAT ) and randomised trial ( first to fourth ) was performed .
RESULTS	Median follow-up was 56 months post transplant .
RESULTS	Patients with pretransplant diabetes comprised 23.4 % ( 147/628 ) , and 22.5 % ( 108/481 ) of the remaining patients developed NODAT .
RESULTS	Pretransplant diabetes had no prognostic influence on first biopsy-proven acute rejection and death-censored graft failure hazard rates , nor on eGFR , but was associated with significantly higher rates of death with a functioning graft ( DWFG ) ( p = 0.003 ) , DWFG due to a cardiovascular event ( p = 0.005 ) and infection that required hospitalisation ( p = 0.03 ) .
RESULTS	NODAT ( t ) had no unfavourable impact on any of these hazard rates nor on eGFR , with actuarial freedom from DWFG remaining at over 90 % among patients in pre - and post-NODAT states at 72 months post transplant/NODAT .
RESULTS	Mean HbA1c for patients in the first to fourth randomised trials , averaged across diabetes category , decreased by trial ( 7.28 % , 6.92 % , 6.87 % and 6.64 % [ 56.1 , 52.1 , 51.6 and 49.1 mmol/mol ] , respectively ; p = 0.02 ) .
CONCLUSIONS	Less-than-expected post-NODAT risk for graft loss and death may exist in the current climate of tighter glucose monitoring post transplant .

###24387872
OBJECTIVE	The aim of this study is to compare the effects of chest physiotherapy ( CPT ) and high-frequency chest wall oscillation ( HFCWO ) on lung function in lung transplant recipients .
BACKGROUND	Chest physiotherapy and HFCWO are routinely used after lung transplant to attenuate dyspnea , increase expiratory flow , and improve secretion clearance .
METHODS	In a two-group experimental , crossover design with repeated-measures , 45 lung transplant recipients ( 27 single , 18 bilateral ; 64 % male ; mean age , 57 years ) were randomized to receive CPT at 10:00 AM and 2:00 PM followed by HFCWO at 6:00 PM and 10:00 PM ( n = 22 ) or vice versa ( n = 23 ) on postoperative day 3 .
METHODS	Dyspnea ( modified Borg score ) , Spo2/FiO2 , and peak expiratory flow ( PEF ) were measured pre-treatment and post-treatment .
METHODS	Data were analyzed using chi-square tests , t tests , and linear mixed effects models .
RESULTS	There was no statistically significant treatment effect for dyspnea or PEF in patients who received HFCWO versus CPT .
RESULTS	However , there was a significant treatment effect on the Spo2/FiO2 ratio ( p < 0.0001 ) .
CONCLUSIONS	Preliminary results suggest that lung function ( measured by Spo2/FiO2 ) improves with HFWCO after lung transplantation .
CONCLUSIONS	Although dyspnea and PEF did not differ significantly between treatment types , HFCWO may be an effective , feasible alternative to CPT .

###25239965
BACKGROUND	Smoking-cessation counseling during pregnancy is important to prevent smoking-related harm in pregnant smokers and their children .
BACKGROUND	Therefore we evaluated the effects of an Inspectorate 's supervision programme on the provision of smoking-cessation counseling by midwifery practices in the Netherlands .
BACKGROUND	The supervision programme consisted of 3 elements : A ) A deadline was announced by which all practices should comply with professional norms on such counseling ( 2011 ) ; B ) A set of randomly selected practices were assessed using a questionnaire and a personal feedback report ( 2010 ) ; C ) Another set of randomly selected practices were assessed through a site visit and a personal feedback report ( 2012 ) .
METHODS	Programme A was evaluated in a before-after study , Programmes B and C were evaluated in a randomized controlled trial ( RCT ) with only a post-intervention measurement .
METHODS	Primary outcome was provision of smoking-cessation counseling through a minimal-intervention strategy ( V-MIS ) .
METHODS	Linear and logistic regression models were used to analyze data from 233 primary-care midwifery practices .
RESULTS	A ) After announcement of the deadline , Dutch midwifery practices reported significantly more provision of smoking-cessation counseling .
RESULTS	For example , the use of V-MIS increased substantially from 28 % to 80 % ; B ) In practices that were assessed with a questionnaire , the provision of counseling improved partially compared to controls ; C ) The provision of counseling did not differ between practices that were visited and their controls .
RESULTS	While the training participation rate in counseling by midwifery practices did not differ between the intervention and control groups , the rate increased significantly in all practices after the start of the supervision programme .
CONCLUSIONS	The provision of smoking-cessation counseling improved spectacularly in Dutch midwifery practices .
CONCLUSIONS	Despite some limitations of our study , the Inspectorate 's supervision programme is likely to have contributed to the improvements in provision of counseling .

###25439367
BACKGROUND	Predictors of asthma exacerbations , poor asthma control , or extreme - agonist overuse may be of clinical utility in the management of asthma .
OBJECTIVE	To investigate characteristics that predict subsequent adverse outcomes in asthma .
METHODS	An independent 24-week , randomized controlled trial of 303 adult patients with asthma who are at risk , which compared the efficacy of SMART ( single budesonide-formoterol inhaler as maintenance and reliever therapy ) with a fixed-dose regimen with salbutamol as reliever ( `` Standard '' ) .
METHODS	Inhaled medication use was measured by electronic monitoring .
METHODS	Baseline characteristics that were predictors of subsequent severe asthma exacerbations , poor asthma control ( Asthma Control Questionnaire -5 score 1.5 ) , and `` extreme '' - agonist overuse ( > 16 budesonide-formoterol actuations/d in SMART and > 32 salbutamol actuations/d in Standard ) were assessed by multivariate analyses .
RESULTS	FEV % predicted ( rate ratio [ RR ] 1.14 [ 95 % CI , 1.03-1 .27 ] per 10 % lower ) , more previous exacerbations ( RR 1.15 [ 95 % CI , 1.01-1 .31 ] ) , Standard therapy ( RR 1.62 [ 95 % CI , 1.07-2 .47 ] ) , and female sex ( RR 2.18 [ 95 % CI , 1.29-3 .67 ] ) were associated with future severe exacerbations .
RESULTS	Asthma Control Questionnaire -- 5 ( regression coefficient 0.20 [ 95 % CI , 0.13-0 .27 ] per 0.5 points higher ) and age ( regression coefficient 0.09 [ 95 % CI , 0.01-0 .17 ] per decade older ) were associated with future poorly controlled asthma .
RESULTS	Higher reliever use ( RR 1.63 [ 95 % CI , 1.36-1 .95 ] per categorical score in Asthma Control Questionnaire question no. 6 ) , Mori ethnicity ( RR 2.20 [ 95 % CI , 1.43-3 .38 ] ) and FEV % predicted ( RR 1.16 [ 95 % CI , 1.03-1 .31 ] per 10 % lower ) were associated with future extreme - agonist overuse .
CONCLUSIONS	Future severe asthma exacerbations , poor asthma control , and extreme - agonist overuse are predicted by different baseline clinical and demographic characteristics and management approaches in at-risk asthma .

###24842697
OBJECTIVE	Epidemiologically , there is a strong relationship between BMI and blood pressure ( BP ) levels .
OBJECTIVE	We prospectively examined randomization to first-step chlorthalidone , a thiazide-type diuretic ; amlodipine , a calcium-channel blocker ; and lisinopril , an angiotensin-converting enzyme inhibitor , on BP control and cardiovascular outcomes in a hypertensive cohort stratified by baseline BMI [ kg/m ( 2 ) ; normal weight ( BMI < 25 ) , overweight ( BMI = 25-29 .9 ) , and obese ( BMI > 30 ) ] .
METHODS	In a randomized , double-blind , practice-based Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial , 33,357 hypertensive participants , aged at least 55 years , were followed for an average of 4.9 years , for a primary outcome of fatal coronary heart disease or nonfatal myocardial infarction , and secondary outcomes of stroke , heart failure , combined cardiovascular disease , mortality , and renal failure .
RESULTS	Of participants , 37.9 % were overweight and 42.1 % were obese at randomization .
RESULTS	For each medication , BP control ( < 140/90 mmHg ) was equivalent in each BMI stratum .
RESULTS	At the fifth year , 66.1 , 66.5 , and 65.1 % of normal-weight , overweight , and obese participants , respectively , were controlled .
RESULTS	Those randomized to chlorthalidone had highest BP control ( 67.2 , 68.3 , and 68.4 % , respectively ) and to lisinopril the lowest ( 60.4 , 63.2 , and 59.6 % , respectively ) in each BMI stratum .
RESULTS	A significant interaction ( P = 0.004 ) suggests a lower coronary heart disease risk in the obese for lisinopril versus chlorthalidone ( hazard ratio 0.85 , 95 % confidence interval 0.74-0 .98 ) and a significant interaction ( P = 0.011 ) suggests a higher risk of end-stage renal disease for amlodipine versus chlorthalidone in obese participants ( hazard ratio 1.49 , 95 % confidence interval 1.06-2 .08 ) .
RESULTS	However , these results were not consistent among other outcomes .
CONCLUSIONS	BMI status does not modify the effects of antihypertensive medications on BP control or cardiovascular disease outcomes .

###24598584
OBJECTIVE	To evaluate the effect of a practice-based , culturally appropriate patient education intervention on blood pressure ( BP ) and treatment adherence among patients of African origin with uncontrolled hypertension .
METHODS	Cluster randomised trial involving four Dutch primary care centres and 146 patients ( intervention n = 75 , control n = 71 ) , who met the following inclusion criteria : self-identified Surinamese or Ghanaian ; 20 years ; treated for hypertension ; SBP 140 mmHg .
METHODS	All patients received usual hypertension care .
METHODS	The intervention-group was also offered three nurse-led , culturally appropriate hypertension education sessions .
METHODS	BP was assessed with Omron 705-IT and treatment adherence with lifestyle - and medication adherence scales .
RESULTS	139 patients ( 95 % ) completed the study ( intervention n = 71 , control n = 68 ) .
RESULTS	Baseline characteristics were largely similar for both groups .
RESULTS	At six months , we observed a SBP reduction of 10 mmHg - primary outcome - in 48 % of the intervention group and 43 % of the control group .
RESULTS	When adjusted for pre-specified covariates age , sex , hypertension duration , education , baseline measurement and clustering effect , the between-group difference was not significant ( OR ; 0.42 ; 95 % CI : 0.11 to 1.54 ; P = 0.19 ) .
RESULTS	At six months , the mean SBP/DBD had dropped by 10/5 .7 ( SD 14.3 / 9.2 ) mmHg in the intervention group and by 6.3 / 1.7 ( SD 13.4 / 8.6 ) mmHg in the control group .
RESULTS	After adjustment , between-group differences in SBP and DBP reduction were -1.69 mmHg ( 95 % CI : -6.01 to 2.62 , P = 0.44 ) and -3.01 mmHg ( -5.73 to -0.30 , P = 0.03 ) in favour of the intervention group .
RESULTS	Mean scores for adherence to lifestyle recommendations increased in the intervention group , but decreased in the control group .
RESULTS	Mean medication adherence scores improved slightly in both groups .
RESULTS	After adjustment , the between-group difference for adherence to lifestyle recommendations was 0.34 ( 0.12 to 0.55 ; P = 0.003 ) .
RESULTS	For medication adherence it was -0.09 ( -0.65 to 0.46 ; P = 0.74 ) .
CONCLUSIONS	This intervention led to significant improvements in DBP and adherence to lifestyle recommendations , supporting the need for culturally appropriate hypertension care .
BACKGROUND	Controlled-Trials .
BACKGROUND	com ISRCTN35675524 .

###24253034
OBJECTIVE	The primary aim of this study was to analyse two different methods of tonsil surgery , tonsillectomy ( TE ) and tonsillotomy ( TT ) , regarding post-operative dentofacial growth in children with tonsillar hypertrophy .
OBJECTIVE	A secondary aim was to analyse these results in relation to cephalometric standards .
METHODS	The study group consisted of 64 subjects ( 39 boys and 25 girls ) , mean age 4.8 years 4 months .
METHODS	They were randomized to a complete removal of the pharyngeal tonsil , TE , ( n = 31 ) or a partial removal , TT , ( n = 33 ) .
METHODS	Pre-operative and 2 years post-operative study material were obtained and analysed .
METHODS	The results were compared with cephalometric standards .
RESULTS	Pre-operative , children with hypertrophic tonsils displayed an increased vertical relation ( P < 0.05 ) compared with cephalometric standards .
RESULTS	Post-operative , no significant difference could be detected between the two surgical procedures regarding dentofacial growth .
RESULTS	Mandibular growth with an anterior inclination was significant ( P < 0.001 / TE , P < 0.01 / TT ) for both groups .
RESULTS	An increased upper and lower incisor inclination was noted ( P < 0.01 / TE , TT ) .
RESULTS	The vertical relation decreased ( P < 0.001 / TE , P < 0.05 / TT ) as well as the mandibular angle ( P < 0.01 / TE , P < 0.001 / TT ) .
RESULTS	Reduction was also significant for the sagittal intermaxillar ( P < 0.001 / TE , TT ) relation .
RESULTS	These post-operative results , together with a more prognatic mandible ( P < 0.05 / TE , TT ) and chin ( P < 0.001 / TE , P < 0.01 / TT ) , might indicate a more horizontal direction of mandibular growth .
CONCLUSIONS	TE and TT yielded equal post-operative dentofacial growth in children treated for hypertrophic tonsils .
CONCLUSIONS	This result should be considered when deciding upon surgical technique .

###24275751
OBJECTIVE	Whether sex-specific chest pain characteristics ( CPCs ) would allow physicians in the emergency department to differentiate women with acute myocardial infarction ( AMI ) from women with other causes of acute chest pain more accurately remains unknown .
OBJECTIVE	OBJECTIVE To improve the management of suspected AMI in women by exploring sex-specific CPCs .
METHODS	From April 21 , 2006 , through August 12 , 2012 , we enrolled 2475 consecutive patients ( 796 women and 1679 men ) presenting with acute chest pain to 9 emergency departments in a prospective multicenter study .
METHODS	The final diagnosis of AMI was adjudicated by 2 independent cardiologists .
METHODS	Treatment of AMI in the emergency department .
METHODS	Sex-specific diagnostic performance of 34 predefined and uniformly recorded CPCs in the early diagnosis of AMI .
RESULTS	Acute myocardial infarction was the adjudicated final diagnosis in 143 women ( 18.0 % ) and 369 men ( 22.0 % ) .
RESULTS	Although most CPCs were reported with similar frequency in women and men , several CPCs were reported more frequently in women ( P < .05 ) .
RESULTS	The accuracy of most CPCs in the diagnosis of AMI was low in women and men , with likelihood ratios close to 1 .
RESULTS	Thirty-one of 34 CPCs ( 91.2 % ) showed similar likelihood ratios for the diagnosis of AMI in women and men , and only 3 CPCs ( 8.8 % ) seemed to have a sex-specific diagnostic performance with P < .05 for interaction .
RESULTS	These CPCs were related to pain duration ( 2-30 and > 30 minutes ) and dynamics ( decreasing pain intensity ) .
RESULTS	However , because their likelihood ratios were close to 1 , the 3 CPCs did not seem clinically helpful .
RESULTS	Similar results were obtained when examining combinations of CPCs ( all interactions , P .05 ) .
CONCLUSIONS	Differences in the sex-specific diagnostic performance of CPCs are small and do not seem to support the use of women-specific CPCs in the early diagnosis of AMI .
CONCLUSIONS	TRIAL REGISTRATION clinicaltrials.gov Identifier : NCT00470587 .

###24916951
OBJECTIVE	To improve mechanistic understanding , this pilot randomized controlled trial examined mediators of an exercise intervention effects on sleep in breast cancer survivors ( BCS ) .
METHODS	Forty-six postmenopausal BCS ( Stage II , off primary treatment ) were randomized to a 3-month exercise intervention or control group .
METHODS	Intervention included 160min/week of moderate intensity aerobic walking , twice weekly resistance training ( resistance bands ) , and six discussion groups ( to improve adherence ) .
METHODS	Blinded assessments at baseline and post-intervention included sleep disturbance ( PSQI and PROMIS ) , objective sleep quality ( accelerometer ) , serum cytokines , accelerometer physical activity , cardiorespiratory fitness , body composition , fatigue , and psychosocial factors .
METHODS	Mediation was tested using Freedman-Schatzkin difference-in-coefficients tests .
RESULTS	When compared with control , the intervention group demonstrated a significant increase in PSQI sleep duration ( i.e. , fewer hours of sleep/night ) ( d = 0.73 , p = .03 ) .
RESULTS	Medium to large but non-significant standardized effect sizes were noted for PSQI daytime somnolence ( d = -0.63 , p = .05 ) and accelerometer latency ( d = -0.49 , p = .14 ) .
RESULTS	No statistically significant mediators were detected for PSQI sleep duration score or accelerometer latency .
RESULTS	Daytime somnolence was mediated by tumor necrosis factor-alpha ( mediated 23 % of intervention effect , p < .05 ) , interleukin ( IL ) -6 : IL-10 ( 16 % , p < .01 ) , IL-8 : IL-10 ( 26 % , p < .01 ) , and fatigue ( 38 % , p < .05 ) .
RESULTS	Mediating or enhancing relationships for several of the sleep outcomes were noted for accelerometer physical activity , PROMIS fatigue , exercise social support , and/or physical activity enjoyment .
CONCLUSIONS	Inflammation and psychosocial factors may mediate or enhance sleep response to our exercise intervention .
CONCLUSIONS	Further study is warranted to confirm our results and translate our findings into more effective interventions aimed at improving sleep quality in BCS .

###25149616
OBJECTIVE	Although the advantages of laparoscopic procedures has been well studied over the last two decade , laparoscopic appendectomy could not to be a standard therapy due to some disadvantages such as longer operative time and higher cost.The objective of our study is to re-evaluate the outcomes of laparoscopic versus open appendectomy with current data .
METHODS	Between January 2012 and July 2012 , the data of the patients who had appendectomy were recorded prospectively .
METHODS	Patients ' demographics , duration of procedure , length of hospital stay , need of analgesics , postoperative visual analogue scale scores and morbidity were assessed .
RESULTS	Of 241 patients , 120 ( 49.8 % ) underwent open and 121 ( 50.2 % ) laparoscopic appendectomy .
RESULTS	The operating time was similar for both groups ( p = 0.855 ) .
RESULTS	The visual analog scale scores of 1st ( p = 0.001 ) , 6th ( p = 0.001 ) and 12th ( p = 0.028 ) hours were higher in open the appendectomy group .
RESULTS	The total need of analgesics significantly was higher in open group ( p = 0.001 ) .
RESULTS	There was no statistical difference in terms of total morbidity rate between open and laparoscopic appendectomy groups ( p = 0.617 ) .
CONCLUSIONS	Two operative techniques are similar in terms of length of hospital stay , operative time , and postoperative complications .
CONCLUSIONS	Laparoscopic appendectomy reduces the need for analgesics and visual analog scale scores ; therefore , it should be considered as the gold standard for surgical treatment of acute appendicitis .

###25534209
OBJECTIVE	Antibiotic resistance has risen dramatically over the past years .
OBJECTIVE	For individual patients , adequate initial antibiotic therapy is essential for clinical outcome .
OBJECTIVE	Computer-assisted decision support systems ( CDSSs ) are advocated to support implementation of rational anti-infective treatment strategies based on guidelines .
OBJECTIVE	The aim of this study was to evaluate long-term effects after implementation of a CDSS .
METHODS	This prospective ` before/after ' cohort study was conducted over four observation periods within 5 years .
METHODS	One preinterventional period ( pre ) was compared with three postinterventional periods : directly after intensive implementation efforts ( post1 ) , 2 years ( post2 ) and 3 years ( post3 ) after implementation .
METHODS	Five anaesthesiological-managed intensive care units ( ICU ) ( one cardiosurgical , one neurosurgical , two interdisciplinary and one intermediate care ) at a university hospital .
METHODS	Adult patients with an ICU stay of > 48 h were included in the analysis .
METHODS	1316 patients were included in the analysis for a total of 12,965 ICU days .
METHODS	Implementation of a CDSS .
METHODS	The primary end point was percentage of days with guideline adherence during ICU treatment .
METHODS	Secondary end points were antibiotic-free days and all-cause mortality compared for patients with low versus high guideline adherence .
RESULTS	Adherence to guidelines increased from 61 % prior to implementation to 92 % in post1 , decreased in post2 to 76 % and remained significantly higher compared with baseline in post3 , with 71 % ( p = 0.178 ) .
RESULTS	Additionally , antibiotic-free days increased over study periods .
RESULTS	At all time periods , mortality for patients with low guideline adherence was higher with 12.3 % versus 8 % ( p = 0.014 ) and an adjusted OR of 1.56 ( 95 % CI 1.05 to 2.31 ) .
CONCLUSIONS	Implementation of computerised regional adapted guidelines for antibiotic therapy is paralleled with improved adherence .
CONCLUSIONS	Even without further measures , adherence stayed high for a longer period and was paralleled by reduced antibiotic exposure .
CONCLUSIONS	Improved guideline adherence was associated with reduced ICU mortality .
BACKGROUND	ISRCTN54598675 .

###25314063
BACKGROUND	Previous investigations in pancreatic cancer suggest a prognostic role for - smooth muscle actin ( - SMA ) expression and stromal density in the peritumoural stroma .
BACKGROUND	The aim of this study was to further validate the impact of - SMA expression and stromal density in resectable pancreatic cancer patients treated with adjuvant gemcitabine compared with untreated patients .
METHODS	CONKO-001 was a prospective randomised phase III study investigating the role of adjuvant gemcitabine as compared with observation .
METHODS	Tissue samples of 162 patients were available for immunohistochemistry on tissue microarrays to evaluate the impact of - SMA expression and stromal density impact on patient outcome .
RESULTS	High - SMA expression in tumour stroma was associated with worse patient outcome ( DFS : P = 0.05 , OS : P = 0.047 ) .
RESULTS	A dense stroma reaction was associated with improved disease-free survival ( DFS ) and overall survival ( OS ) in the overall study population ( DFS : P = 0.001 , OS : P = 0.001 ) .
RESULTS	This positive prognostic impact was restricted to patients with no adjuvant treatment ( DFS : P < 0.001 , OS : P < 0.001 ) .
RESULTS	In multivariable analysis , - SMA and stromal density expression were independently predictive factors for survival .
CONCLUSIONS	Our data confirm the negative prognostic impact of high - SMA expression in pancreatic cancer patients after curatively intended resection .
CONCLUSIONS	In contrast to former investigations , we found a positive prognostic impact for a dense stroma .
CONCLUSIONS	This significant influence was restricted to patients who received no adjuvant therapy .

###24866478
BACKGROUND	The CRTH2 antagonist OC000459 has previously been demonstrated to reduce airway inflammation and improve lung function in moderate persistent asthma .
BACKGROUND	A study was conducted to determine the effect of lower once daily doses of OC000459 and to define the phenotype of subjects most responsive to treatment .
METHODS	Adult subjects ( percentage of predicted forced expiratory volume in 1s ( FEV1 ) 60-85 % ) were randomized to OC000459 at three dose levels ( 25mg once daily , 200mg once daily or 100mg twice daily ) or placebo for 12weeks ( n = 117-125 per group , full analysis set ) .
METHODS	The primary endpoint was the change from baseline in prebronchodilator FEV1 , and secondary endpoints included Asthma Control Questionnaire ( ACQ ) and Standardised Asthma Quality of Life Questionnaire [ AQLQ ( S ) ] , and incidence of exacerbations and respiratory tract infections .
RESULTS	OC459 caused a significant improvement in FEV1 compared with placebo at a dose of 25mg once daily ( P = 0.028 ) .
RESULTS	A similar increase was observed in the other dose groups , and the mean change in FEV1 in the pooled dose groups at endpoint was 95ml greater than placebo ( P = 0.024 ) .
RESULTS	In a post hoc analysis of atopic eosinophilic subjects with uncontrolled asthma , a mean increase in FEV1 of 220ml was observed compared with placebo ( P = 0.005 ) .
RESULTS	The mean increase in FEV1 was more marked in younger subjects in this group : for subjects aged 40years , there was a mean increase of 355ml compared with placebo ( P = 0.007 ) .
RESULTS	Improvements in ACQ and AQLQ ( S ) were observed in both the full analysis set and the atopic eosinophilic subgroup .
RESULTS	There was a lower incidence of exacerbations and respiratory infections in subjects treated with OC000459 .
RESULTS	There were no drug-related serious adverse events .
CONCLUSIONS	OC000459 is a safe and effective oral anti-inflammatory agent , which achieved clinically meaningful improvements in lung function and asthma control in allergic asthmatics with an eosinophil-dominant form of the disease .
CONCLUSIONS	A dose of 25mg given once daily was as effective as the higher doses studied .

###24827136
BACKGROUND	Squamous cell carcinoma of the anus ( SCCA ) is highly sensitive to chemoradiation ( CRT ) which achieves good loco-regional control and preserves anal function .
BACKGROUND	However , some patients require permanent stoma formation either as a result of surgery on relapse , poor anal function or treatment-related symptoms .
BACKGROUND	Our aim was to determine patient , tumour and treatment-related colostomy rates following CRT and maintenance chemotherapy in the ACT II trial .
METHODS	The ACT II trial recruited 940 patients comparing 5FU-based CRT using cisplatin ( CisP ) or mitomycin C ( MMC ) with or without additional maintenance chemotherapy .
METHODS	We investigated the association between colostomy-free survival ( CFS ) and progression-free survival ( PFS ) with age , gender , T-stage , N-stage , treatment and baseline haemoglobin .
RESULTS	The median follow-up was 5.1 years ( n = 884 evaluable/940 ) ; tumour site canal ( 84 % ) , margin ( 14 % ) ; stage T1/T2 ( 52 % ) , T3/T4 ( 46 % ) ; N + ( 32 % ) , N0 ( 62 % ) .
RESULTS	Twenty out of 118 ( 17 % ) colostomies fashioned before CRT were reversed within 8 months .
RESULTS	One hundred and twelve patients had a post-treatment colostomy due to persistent disease ( 98 ) or morbidity ( 14 ) .
RESULTS	Fifty-two per cent ( 61/118 ) of all pre-treatment colostomies were never reversed .
RESULTS	The 5-year CFS rates were 68 % MMC/Maint , 70 % CisP/Maint , 68 % MMC/No-maint and 65 % CisP/No-maint .
RESULTS	CRT with CisP did not improve CFS when compared with MMC ( hazard ratio : 1.04 , 95 % confidence interval : 0.82-1 .31 , P = 0.74 ) .
RESULTS	The 5-year CFS rates were higher for T1/T2 ( 79 % ) than T3/T4 ( 54 % ) tumours and higher for node-negative ( 72 % ) than node-positive ( 60 % ) patients .
RESULTS	Significant predictors of CFS were gender , T-stage and haemoglobin , while treatment factors had no impact on outcome .
RESULTS	Similar associations were found between PFS and tumour/treatment-related factors .
CONCLUSIONS	The majority ( 52 % ) of pre-treatment colostomies were never reversed .
CONCLUSIONS	Neither CRT with 5FU/CisP nor maintenance chemotherapy impacted on CFS .
CONCLUSIONS	The low risk of colostomy for late effects ( 1.7 % ) is likely to be associated with the modest total radiotherapy dose .
CONCLUSIONS	The predictive factors for CFS were T-stage , gender and baseline haemoglobin .
BACKGROUND	ISRCTN 26715889 .

###25500100
BACKGROUND	Prior studies have suggested that low baseline quality-of-life ( QOL ) scores predict worse survival in patients undergoing lung cancer surgery .
BACKGROUND	However , these studies involved average-risk patients undergoing lobectomy .
BACKGROUND	We report QOL results from a multicenter trial , American College of Surgeons Oncology Group Z4032 , which randomized high-risk operable patients to sublobar resection ( SR ) , or SR with brachytherapy , and included longitudinal QOL assessments .
METHODS	Global QOL , using the 36-item Short-Form Health Survey ( SF36 ) , and the dyspnea score from the University of California , San Diego Shortness of Breath Questionnaire ( SOBQ ) scale , was measured at baseline , 3 , 12 , and 24 months .
METHODS	SF36 physical component summary ( PCS ) and mental component summary ( MCS ) scores were standardized and adjusted for age and gender normals , with scores < 50 indicating below-average health status .
METHODS	SOBQ scores were transformed to a 0-100 ( poor-excellent ) scale .
METHODS	Aims were to : ( 1 ) determine the impact of baseline scores on recurrence-free survival , overall survival , and 30-day adverse events ( AEs ) ; and ( 2 ) identify subgroups ( surgical approach , resection type .
METHODS	tumor location , tumor size , respiratory function ) with a 10-point decline or improvement in QOL after SR. .
RESULTS	Two hundred twelve eligible patients were included .
RESULTS	There were no significant differences in baseline QOL scores between arms .
RESULTS	Median baseline PCS , MCS , and SOBQ scores were 42.7 , 51.1 , and 70.8 , respectively .
RESULTS	There were no differences in grade-3 + AEs , overall survival , or recurrence-free survival in patients with baseline scores median versus > median values , except for a significantly worse overall survival for patients with baseline SOBQ scores median value .
RESULTS	There were no significant differences between the study arms in percentage change of QOL scores from baseline to 3 , 12 , or 24 months .
RESULTS	Further comparison combining the 2 arms demonstrated a higher percentage of patients with a 10-point decline in SOBQ scores with segmentectomy compared with wedge resection ( 40.5 % vs 21.9 % , P = .03 ) at 12 months , with thoracotomy versus video-assisted thoracic surgery ( VATS ) ( 38.8 % vs 20.4 % , P = .03 ) at 12 months , and T1b versus T1a tumors ( 46.9 % vs 23.5 % , P = .020 ) at 24 months .
RESULTS	A 10-point improvement in PCS score was seen at 3 months with VATS versus thoracotomy ( 16.5 % vs 3.6 % , P = .02 ) .
CONCLUSIONS	In high-risk operable patients , poor baseline QOL scores were not predictive for worse overall or recurrence-free survival , or for higher risk for AEs following SR. .
CONCLUSIONS	VATS was associated with improvement in physical function at 3 months , and improved dyspnea scores at 12 months , lending support for the preferential use of VATS when SR is undertaken .

###24844530
OBJECTIVE	The purpose of this study was to develop a new Internet-based computerized cognitive behavior therapy ( iCBT ) program in Manga format , the Japanese cartoon , for workers and to examine the effects of the iCBT program on improving subthreshold depression using a randomized controlled trial ( RCT ) design among workers employed in private companies in Japan .
METHODS	All workers in a company ( n = 290 ) and all workers in three departments ( n = 1,500 ) at the headquarters of another large company were recruited by an invitation e-mail .
METHODS	Participants who fulfilled the inclusion criteria were randomly allocated to intervention or control groups ( N = 381 for each group ) .
METHODS	A six-week , six-lesson iCBT program using Manga ( Japanese comic ) story was developed .
METHODS	The program included several CBT skills : self-monitoring , cognitive restructuring , assertiveness , problem solving , and relaxation .
METHODS	The intervention group studied the iCBT program at a frequency of one lesson per week .
METHODS	Depression ( Beck Depression Inventory II ; BDI-II ) was assessed as a primary outcome at baseline , and three - and six-month follow-ups for both intervention and control groups were performed .
RESULTS	The iCBT program showed a significant intervention effect on BDI-II ( t = -1.99 , p < 0.05 ) with small effect sizes ( Cohen 's d : -0.16 , 95 % Confidence Interval : -0.32 to 0.00 , at six-month follow-up ) .
CONCLUSIONS	The present study first demonstrated that a computerized cognitive behavior therapy delivered via the Internet was effective in improving depression in the general working population .
CONCLUSIONS	It seems critical to improve program involvement of participants in order to enhance the effect size of an iCBT program .
BACKGROUND	UMIN Clinical Trials Registry UMIN000006210 .

###25539571
BACKGROUND	Nutritional support is crucial to the management of patients receiving invasive mechanical ventilation ( IMV ) and the most commonly prescribed treatment in intensive care units ( ICUs ) .
BACKGROUND	International guidelines consistently indicate that enteral nutrition ( EN ) should be preferred over parenteral nutrition ( PN ) whenever possible and started as early as possible .
BACKGROUND	However , no adequately designed study has evaluated whether a specific nutritional modality is associated with decreased mortality .
BACKGROUND	The primary goal of this trial is to assess the hypothesis that early first-line EN , as compared to early first-line PN , decreases day 28 all-cause mortality in patients receiving IMV and vasoactive drugs for shock .
METHODS	The NUTRIREA-2 study is a multicenter , open-label , parallel-group , randomized controlled trial comparing early PN versus early EN in critically ill patients requiring IMV for an expected duration of at least 48hours , combined with vasoactive drugs , for shock .
METHODS	Patients will be allocated at random to first-line PN for at least 72hours or to first-line EN .
METHODS	In both groups , nutritional support will be started within 24hours after IMV initiation .
METHODS	Calorie targets will be 20 to 25kcal/kg/day during the first week , then 25 to 30kcal/kg/day thereafter .
METHODS	Patients receiving PN may be switched to EN after at least 72hours in the event of shock resolution ( no vasoactive drugs for 24 consecutive hours and arterial lactic acid level below 2mmol/L ) .
METHODS	On day 7 , all patients receiving PN and having no contraindications to EN will be switched to EN .
METHODS	In both groups , supplemental PN may be added to EN after day 7 in patients with persistent intolerance to EN and inadequate calorie intake .
METHODS	We plan to recruit 2,854 patients at 44 participating ICUs .
CONCLUSIONS	The NUTRIREA-2 study is the first large randomized controlled trial designed to assess the hypothesis that early EN improves survival compared to early PN in ICU patients .
CONCLUSIONS	Enrollment started on 22 March 2013 and is expected to end in November 2015 .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01802099 ( registered 27 February 2013 ) .

###24719397
BACKGROUND	Potassium-titanyl-phosphate ( KTP ) laser photocoagulation is commonly used for treatment of hereditary hemorrhagic telangiectasia-related epistaxis ( HHT-RE ) .
BACKGROUND	Electrosurgical plasma coagulation ( EPC ) , also known as coblation , has not been rigorously evaluated for HHT-RE .
METHODS	Patients seeking treatment for HHT-RE between September 2010 and September 2012 were prospectively randomized ( 1:1 ) to KTP or EPC in a single blind prospective cohort study .
METHODS	Length of surgery and estimated blood loss ( EBL ) were recorded .
METHODS	Epistaxis severity scores ( ESSs ) and 10-cm visual analogue scale ( VAS ) scores for HHT-RE-related symptoms were administered at enrollment and at 3 , 6 , 12 months following surgery .
METHODS	Statistical analysis used Friedman 's and Pearson 's chi-square tests .
RESULTS	Eleven HHT patients were prospectively enrolled and followed .
RESULTS	Six patients underwent EPC treatment while 5 underwent KTP .
RESULTS	Three patients in the KTP subgroup and 2 patients in the EPC subgroup requested additional surgical treatment within 12 months ( p > 0.999 ) .
RESULTS	There were no significant differences in terms of EBL ( p = 0.126 ) and length of surgery ( p = 0.429 ) between treatment groups .
RESULTS	Mean ESSs were not significantly different between groups at any follow-up point ( KTP , p = 0.896 ; EPC , p = 0.159 ) .
RESULTS	Compared to KTP , mean ESSs were higher in the EPC subgroup at baseline and lower at all other time points .
RESULTS	Mean nasal obstruction VAS scores were significantly lower in the EPC subgroup at all follow-up points .
CONCLUSIONS	EPC is a viable alternative to KTP laser photocoagulation for epistaxis control in patients with HHT .
CONCLUSIONS	Subjectively , patients experience less nasal obstruction following EPC as compared to KTP treatment .
CONCLUSIONS	A multicentered , well-powered study is warranted to better determine treatment outcomes .

###25499939
BACKGROUND	Xuezhikang ( XZK ) is an extract of fermented red yeast rice that has lipid-lowering properties .
OBJECTIVE	To evaluate the effects of XZK on lipids in subjects with dyslipidemia but no coronary heart disease .
METHODS	A total of 116 adults with baseline non-high-density lipoprotein cholesterol ( non-HDL-C ) levels of approximately 208mg/dL and low-density lipoprotein cholesterol ( LDL-C ) levels of approximately 175mg/dL were randomized to either placebo or XZK 1200 or 2400mg daily and treated for 12weeks .
RESULTS	A majority of the patients were white ( 53.4 % ) or Asian ( 37.1 % ) .
RESULTS	Daily XZK 1200mg and 2400mg for 4 to 12weeks resulted in statistically significant ( P < .001 ) and clinically meaningful decreases in non-HDL-C ( 24 % reduction ) and LDL-C ( 27 % reduction ) compared with placebo .
RESULTS	XZK treatment at either dose enabled approximately 50 % of subjects to reduce their LDL-C levels by30 % .
RESULTS	Doubling the XZK daily dose from 1200 to 2400mg at treatment week 8 caused an additional 4.6 % reduction in LDL-C .
RESULTS	Significant benefits were also observed across secondary efficacy variables , including total cholesterol ( TC ) , apolipoprotein B ( Apo B ) , triglycerides , HDL-C , the TC/HDL-C ratio , and the Apo B/Apo A-I ratio , at treatment week 8 or 12 .
RESULTS	XZK was safe and well tolerated .
RESULTS	Safety and tolerability profiles were similar across treatment groups .
RESULTS	Most adverse events were gastrointestinal .
RESULTS	No subject experienced myopathy or markedly elevated liver transaminases or creatine kinase .
CONCLUSIONS	Xuezhikang significantly reduced non-HDL-C and LDL-C , and was well tolerated .
CONCLUSIONS	Further , longer-term studies in more diverse patient populations are needed to corroborate these findings .

###25590761
BACKGROUND	No prior study has compared the efficacy of bifrontal ( BF ) vs right unilateral ( RUL ) electroconvulsive therapy ( ECT ) by including the subgroup that is most likely to receive it : only elderly patients with major depression ( MD ) .
METHODS	This single-site , randomized , assessor-blinded , controlled trial was conducted from 2009 to 2013 .
METHODS	Seventy-three elderly patients with MD , unipolar and bipolar , were treated with a course of formula-based BF ECT or RUL ECT .
METHODS	The 17-item Hamilton Rating Scale for Depression ( HRSD17 ) was used to measure efficacy .
METHODS	Safety was assessed with the Mini Mental State Examination ( MMSE ) .
RESULTS	Both electrode placements resulted in highly significant downward trends in symptom severity ( all p < 0.001 ) , with a non-significant difference between methods ( p = 0.703 ) .
RESULTS	At the end of the ECT course , response rates for the BF and RUL group were 63.9 % and 67.6 % , respectively .
RESULTS	Short-term remission , defined as an HRSD17 score7 , was achieved in 14 ( 38.9 % ) patients in the BF group and 19 ( 51.4 % ) patients in the RUL group .
RESULTS	Global cognitive function , as measured by the MMSE , did not deteriorate in the two treatment groups .
CONCLUSIONS	The small number of subjects may have led to reduced power to detect real differences .
CONCLUSIONS	The MMSE is not sufficient to ascertain the negative effect of ECT on cognition .
CONCLUSIONS	This study indicates that formula-based BF and RUL ECT are equally efficacious , and that remission rates of formula-based dosing are lower than those previously reported for titrated dosing , in a clinical sample of elderly patients with MD. .
BACKGROUND	ClinicalTrials.gov NCT01559324 .

###24496084
OBJECTIVE	Aging induces a shift in circulating hormones in women , accompanied by weight gain during the late reproductive , menopausal transition , and postmenopausal years .
OBJECTIVE	Exercise has been shown to counter weight gain ; however , it might increase circulating androgens .
OBJECTIVE	A 6-month aerobic and resistance training exercise regimen was implemented to examine interrelationships between circulating sex hormones , body composition , aerobic capacity , insulin sensitivity , and insulin resistance .
METHODS	Twenty-eight women , aged 42 to 52 years , completed the 6-month intervention study .
METHODS	They were randomly assigned to either a control ( CON ; n = 10 ) group-and maintained their sedentary lifestyle-or an exercise intervention ( EXE ; n = 18 ) group .
METHODS	The exercise intervention consisted of combined aerobic and resistance workouts scheduled 6 days/week for 60 minutes/day .
METHODS	Body weight , composition , VO2 peak , plasma insulin , glucose , lipid profile , estradiol , testosterone , progesterone , dehydroepiandrosterone , and dehydroepiandrosterone sulfate ( DHEAS ) were measured at baseline and on month 6 .
METHODS	Insulin sensitivity was estimated using the insulin sensitivity index and the quantitative insulin sensitivity check index , whereas insulin resistance was estimated using the homeostatic model for insulin resistance .
RESULTS	There was a trend toward increased DHEAS in both groups ( P < 0.1 ) , but not as a function of the intervention .
RESULTS	Insulin sensitivity index increased in the EXE group compared with the CON group ( P < 0.01 ) .
RESULTS	Multiple linear regression indicated that , at 6 months , DHEAS was a negative contributor to insulin sensitivity in the EXE group , but not in the CON group .
CONCLUSIONS	In midlife women , an increase in circulating DHEAS , such as that previously reported during the menopausal transition , is associated with higher insulin resistance , but exercise can mitigate this risk by improving insulin sensitivity , thereby countering the effects of DHEAS .

###25294064
OBJECTIVE	To evaluate the effect of child obesity intervention comprehensive program on the improvement of overweight , obese control and knowledge-attitude-practice .
METHODS	The study design was under cluster-randomized controlled trial , with 965 children in the intervention and 895 children in the control groups .
METHODS	Repeated measurement data on child obesity was analyzed through Generalized Estimating Equation models .
RESULTS	The risk of becoming overweight or obesity in the intervention group was 0.824 times more than children in the control group , showing a reduction of 17.6 % the risk of being overweight or obese ( P = 0.031 ) .
RESULTS	In addition , the possibility of increasing one unit of correct rate on obesity related knowledge , children in the intervention group children was 1.044 times ( P = 0.001 ) than in the control group .
RESULTS	On the mean obesity related correct attitude rate , it was 1.023 times ( P = 0.001 ) in the intervention group of the control group .
RESULTS	Regarding the possibility of increasing one unit om the mean obesity related behavior score , children in the intervention group was 1.522 times ( P = 0.001 ) than those in the control group ( P = 0.046 ) .
CONCLUSIONS	The comprehensive child obesity intervention program could effectively reduce the risk of developing overweight or obesity and improving the obesity related knowledge , attitude and behavior in children .

###24390808
OBJECTIVE	This study aimed to determine whether the Physical Activity and Lymphedema ( PAL ) trial weight training program for breast cancer survivors at risk of or with breast cancer-related lymphedema provided skeletal benefits .
METHODS	Of the 295 participants in the randomized controlled PAL trial , 258 ( weight training ; N = 128 ; control , N = 130 ) had complete measures of bone mineral density ( BMD ( in grams per square centimeter ) ) of the proximal femur and lumbar spine and were also categorized by T scores .
METHODS	Women in the weight training group performed slowly progressive weight training 2 days/week for 12 months compared to women in the control group who maintained their usual physical activities .
RESULTS	There were no significant differences in the rate of BMD change at any skeletal site between weight training and control groups , regardless of menopausal status .
RESULTS	Distribution of bone health categories was not significantly different between groups at baseline , but became different at 12 months ( p < 0.03 ) among postmenopausal women due to an increase in the percentage of controls who became osteopenic ( 35 to 44 % ) compared to stable bone health in weight lifters .
CONCLUSIONS	The PAL weight training program that increased muscle strength without exacerbating or causing lymphedema among breast cancer survivors was not as efficacious at improving skeletal health .
CONCLUSIONS	The skeletal loads produced from the PAL program may be insufficient to notably shift BMD , but may have a subtle osteogenic effect .
CONCLUSIONS	The safety and efficacy of rigorous weight training programs for improving skeletal health in women at risk for or with breast cancer-related lymphedema remain to be determined .

###24470433
BACKGROUND	Patients suffering from chronic kidney disease are at greater risk of developing infection than the normal population , and infections are the second cause of mortality after cardiovascular complications in this population .
BACKGROUND	Some reports suggest that the intake of active vitamin D might be beneficial to prevent infections .
BACKGROUND	Therefore , we aimed to determine if the oral intake of vitamin D receptor activator ( VDRA ) is associated with a lower risk of infection-related hospitalization ( IRH ) among incident chronic hemodialysis patients .
METHODS	We conducted a nested case-control study in a cohort of 4933 patients initiating chronic hemodialysis between 1 January 2001 and 31 December 2007 in Quebec , Canada , using administrative databases .
METHODS	We identified cases of hospital admission indicating an infection as main diagnosis on the hospital 's discharge sheet .
METHODS	Up to 10 controls were randomly selected for each case .
METHODS	Association between oral VDRA use and risk of IRH was estimated using conditional logistic regression .
RESULTS	We identified 1136 cases of IRH and 10396 controls during the study period .
RESULTS	The intake of VDRA was not associated with the risk of being hospitalized due to an infection ( odds ratio [ OR ] , 1.07 ; 95 % confidence interval [ CI ] , 0.95-1 .20 ) .
RESULTS	Using the prior 6-month cumulative dose of VDRA , we also found that a cumulative VDRA dose of less than 45 mcg ( OR , 1.05 ; 95 % CI , 0.92-1 .19 ) or greater than 45 mcg ( OR , 1.15 ; 95 % CI , 0.96-1 .36 ) was not associated with the IRH risk .
CONCLUSIONS	The oral intake of VDRA was not associated with the risk of IRH in incident hemodialysis patients .

###25698407
OBJECTIVE	We assessed differences in treatment between the screening and control arms of ERSPC Rotterdam and studied whether possible treatment differences could explain the positive study outcome .
METHODS	In ERSPC Rotterdam men 55 to 74 years old were randomized to a screening arm of 21,210 and a control arm of 21,166 .
METHODS	Treatment after diagnosis was at the discretion of the care provider chosen by the patient .
METHODS	Initial treatment was compared in 4 risk groups .
METHODS	The relation between prostate cancer incidence and prostate cancer mortality was assessed by risk group by correlating the incidence RR and the mortality RR .
METHODS	A direct relation would have supported a stage shift as the main cause of changes in prostate cancer mortality .
RESULTS	Initial treatment differed between the arms in the low , intermediate and high risk groups but not in the metastatic group .
RESULTS	The RRs of prostate cancer incidence and mortality per risk group were related 1:1 ( regression line slope 1.00 , 95 % CI 0.30-1 .74 ) .
RESULTS	Of changes in prostate cancer mortality 94 % could be explained by changes in prostate cancer incidence .
RESULTS	This made treatment differences unlikely as the reason for the observed decrease in prostate cancer mortality .
CONCLUSIONS	Differences in treatment between the ERSPC Rotterdam screening and control arms were unlikely to explain the differences in prostate cancer mortality .
CONCLUSIONS	Results are instead consistent with a decrease in prostate cancer mortality as the result of a favorable stage through screening .

###24897082
BACKGROUND	Dalbavancin , a lipoglycopeptide antibiotic agent that is active against gram-positive pathogens , has a long plasma half-life , allowing for once-weekly dosing .
BACKGROUND	DISCOVER 1 and DISCOVER 2 were identically designed noninferiority trials of dalbavancin for the treatment of acute bacterial skin and skin-structure infection .
METHODS	We randomly assigned patients to receive dalbavancin intravenously on days 1 and 8 or vancomycin intravenously for at least 3 days with the option to switch to oral linezolid to complete 10 to 14 days of therapy .
METHODS	The primary end point , early clinical response , required the cessation of spread of infection-related erythema and the absence of fever at 48 to 72 hours .
METHODS	Secondary end points at the end of therapy included clinical status and investigator 's assessment of outcome .
RESULTS	Analysis of the primary end point showed noninferiority of dalbavancin in both DISCOVER 1 and DISCOVER 2 .
RESULTS	In the pooled analysis , 525 of 659 patients ( 79.7 % ) in the dalbavancin group and 521 of 653 ( 79.8 % ) in the vancomycin-linezolid group had an early clinical response indicating treatment success ( weighted difference , -0.1 percentage point ; 95 % confidence interval , -4.5 to 4.2 ) .
RESULTS	The outcomes were similar in the analyses by study and the pooled analyses of clinical status at the end of therapy and the investigator 's assessment of outcome .
RESULTS	For patients infected with Staphylococcus aureus , including methicillin-resistant S. aureus , clinical success was seen in 90.6 % of the patients treated with dalbavancin and 93.8 % of those treated with vancomycin-linezolid .
RESULTS	Adverse events and study days with an adverse event were less frequent in the dalbavancin group than in the vancomycin-linezolid group .
RESULTS	The most common treatment-related adverse events in either group were nausea , diarrhea , and pruritus .
CONCLUSIONS	Once-weekly intravenous dalbavancin was not inferior to twice-daily intravenous vancomycin followed by oral linezolid for the treatment of acute bacterial skin and skin-structure infection .
CONCLUSIONS	( Funded by Durata Therapeutics ; DISCOVER 1 and DISCOVER 2 ClinicalTrials.gov numbers , NCT01339091 and NCT01431339 . )

###24376099
BACKGROUND	The primary aim of this study was to evaluate the long-term safety/tolerability of atomoxetine in Japanese adults with attention deficit hyperactivity disorder ( ADHD ) .
METHODS	This 48-week , open-label extension study involved participants with ADHD who completed a 10-week randomized controlled trial of atomoxetine .
METHODS	Participants received atomoxetine 40mg/day , followed by step-wise titration to a maximum of 120mg/day .
METHODS	The primary outcome was safety/tolerability .
METHODS	Secondary outcomes were symptoms of ADHD ( Conners ' Adult ADHD Rating Scales-Investigator Rated : Screening Version 18-item total score ) , quality of life ( Adult Attention-Deficit/Hyperactivity Disorder Quality of Life scale ) , and executive function ( Behavior Rating Inventory of Executive Function-Adult Version : Self-report ) .
RESULTS	Of the 39.5 % of participants overall who discontinued the study , 15.9 % ( 37/233 ) of participants discontinued because of adverse events ( AEs ) , primarily nausea ( 4.3 % ; 10/233 ) .
RESULTS	Overall , 93.6 % ( 218/233 ) of participants experienced treatment-emergent AEs ( TEAEs ) , most commonly nausea ( 56.2 % ; 131/233 ) , nasopharyngitis ( 25.3 % ; 59/233 ) , thirst ( 19.3 % ; 45/233 ) , headache ( 17.2 % ; 40/233 ) , and decreased appetite ( 16.3 % ; 38/233 ) .
RESULTS	Most TEAEs ( 70.8 % ; 165/233 ) were mild in intensity .
RESULTS	Overall , 79.8 % ( 186/233 ) of participants experienced 1 adverse drug reaction , primarily nausea ( 55.4 % ; 129/233 ) .
RESULTS	Five participants experienced serious AEs during the open-label extension ; none was related/possibly related to treatment .
RESULTS	There were statistically significant increases in vital signs and decreases in body weight that were not considered clinically significant .
RESULTS	Symptoms of ADHD , quality of life , and executive function were significantly improved from baseline to endpoint ( P < 0.05 ) .
CONCLUSIONS	Despite discontinuations due to the long-term , open-label design , AE related discontinuations were modest , suggesting that atomoxetine has acceptable long-term safety and tolerability in Japanese adults with ADHD .
CONCLUSIONS	Symptoms of ADHD improved and remained improved throughout the study .

###24268858
OBJECTIVE	To compare the efficacy and safety between low-fluence photodynamic therapy ( PDT ) and the intravitreal ranibizumab in the treatment of chronic central serous chorioretinopathy ( CSC ) .
METHODS	Prospective , randomized , single-center , parallel-arm , controlled trial .
METHODS	Thirty-four eyes of 32 patients with chronic CSC with > 6 months ' duration of symptoms or recurrent CSC were randomly placed into the low-fluence PDT group ( n = 18 ) or the ranibizumab group ( n = 16 ) .
METHODS	The patients underwent a single session of low-fluence PDT or 3 consecutive monthly injections of ranibizumab .
METHODS	Rescue treatment was available from month 3 if the subretinal fluid ( SRF ) persisted or recurred after primary treatment ; low-fluence PDT was given to the ranibizumab group and intravitreal ranibizumab to the low-fluence PDT group .
METHODS	The primary outcome was the proportion of eyes with complete resolution of SRF without rescue treatment .
METHODS	Secondary outcomes included the mean changes in logarithm of the minimum angle of resolution best-corrected visual acuity ( BCVA ) , central retinal thickness ( CRT ) , and angiographic findings from baseline to 12 months .
RESULTS	At month 12 , 16 eyes ( 88.9 % ) of the low-fluence PDT group maintained complete resolution of SRF without rescue treatment versus 2 eyes ( 12.5 % ) in the ranibizumab group ( P < 0.001 ) .
RESULTS	Two eyes ( 11.1 % ) in the low-fluence PDT group and 11 eyes ( 68.8 % ) in the ranibizumab group met the criteria for rescue treatment ( P = 0.001 ) .
RESULTS	In the low-fluence PDT group , the mean decrease in CRT from baseline was significantly greater than that in the ranibizumab group until month 6 ( P < 0.05 ) , but the differences became insignificant thereafter .
RESULTS	The improvement in BCVA from baseline was superior in the low-fluence PDT group to that in the ranibizumab group , but the differences were not statistically significant except at month 3 ( P = 0.025 ) .
RESULTS	On indocyanine green angiography , a significantly greater proportion of the low-fluence PDT group ( 16 eyes ; 88.9 % ) showed a marked reduction in choroidal hyperpermeability after primary treatment than that of the ranibizumab group ( 0 eyes ; P < 0.001 ) .
RESULTS	No serious adverse events related to the drugs or procedures were observed .
CONCLUSIONS	This study represents the overall superiority of low-fluence PDT compared with intravitreal ranibizumab in the treatment of chronic CSC .

###24684853
OBJECTIVE	Drinking water induces short-term cardiovascular and metabolic changes .
OBJECTIVE	These effects are considered to be triggered by gastric distension and osmotic factors , but little is known about the influence of water temperature .
METHODS	We determined , in a randomized crossover study , the acute cardiovascular and metabolic responses to 500 mL of tap water at 3 C ( cold ) , 22 C ( room ) and 37 C ( body ) in 12 young humans to ascertain an effect of water temperature .
METHODS	We measured continuous beat-to-beat haemodynamics , skin blood flux with laser-Doppler flowmetry and resting energy expenditure by indirect calorimetry starting with a 30-min baseline followed by a 4-min drink period and a subsequent 90-min post-drink observation .
RESULTS	Ingestion of cold - and room-tempered water led to decreased heart rate ( P < 0.01 ) and double product ( P < 0.01 ) , and increased stroke volume ( P < 0.05 ) ; these effects were not observed with body-tempered water .
RESULTS	Drinking cold - and room - , but not body-tempered water , led to increased high frequency power of heart rate variability ( P < 0.05 ) and baroreflex sensitivity ( P < 0.05 ) .
RESULTS	Cold - and room-tempered water increased energy expenditure over 90 min by 2.9 % ( P < 0.05 ) and 2.3 % ( ns ) , respectively , accompanied by a diminished skin blood flux ( P < 0.01 ) , thereby suggesting that both small increases in heat production together with decreased heat loss contribute to warming up the ingested water to intra-abdominal temperature levels .
CONCLUSIONS	Overall , ingestion of cold - and room - , but not body-tempered water reduced the workload to the heart through a reduction in heart rate and double product which could be mediated by an augmented cardiac vagal tone .

###25338555
BACKGROUND	Post-term pregnancy , a pregnancy exceeding 294 days or 42 completed weeks , is associated with increased perinatal morbidity and mortality and is considered a high-risk condition which requires specialist surveillance and induction of labour .
BACKGROUND	However , there is uncertainty on the policy concerning the timing of induction for post-term pregnancy or impending post-term pregnancy , leading to practice variation between caregivers .
BACKGROUND	Previous studies on induction at or beyond 41 weeks versus expectant management showed different results on perinatal outcome though conclusions in meta-analyses show a preference for induction at 41 weeks .
BACKGROUND	However , interpretation of the results is hampered by the limited sample size of most trials and the heterogeneity in design .
BACKGROUND	Most control groups had a policy of awaiting spontaneous onset of labour that went far beyond 42 weeks , which does not reflect usual care in The Netherlands where induction of labour at 42 weeks is the regular policy .
BACKGROUND	Thus leaving the question unanswered if induction at 41 weeks results in better perinatal outcomes than expectant management until 42 weeks .
METHODS	In this study we compare a policy of labour induction at 41 + 0 / +1 weeks with a policy of expectant management until 42 weeks in obstetrical low risk women without contra-indications for expectant management until 42 weeks and a singleton pregnancy in cephalic position .
METHODS	We will perform a multicenter randomised controlled clinical trial .
METHODS	Our primary outcome will be a composite outcome of perinatal mortality and neonatal morbidity .
METHODS	Secondary outcomes will be maternal outcomes as mode of delivery ( operative vaginal delivery and Caesarean section ) , need for analgesia and postpartum haemorrhage ( 1000 ml ) .
METHODS	Maternal preferences , satisfaction , wellbeing , pain and anxiety will be assessed alongside the trial .
CONCLUSIONS	This study will provide evidence for the management of pregnant women reaching a gestational age of 41 weeks .
BACKGROUND	Dutch Trial Register ( Nederlands Trial Register ) : NTR3431 .
BACKGROUND	Registered : 14 May 2012 .

###24375941
BACKGROUND	The objective of this study was to evaluate citalopram for executive functioning in Huntington 's disease ( HD ) .
METHODS	The study was randomized , double-blind , and placebo-controlled .
METHODS	Thirty-three adults with HD , cognitive complaints , and no depression ( Hamilton Depression [ HAM-D ] rating scale 12 ) were administered citalopram 20 mg or placebo ( 7 visits , 20 weeks ) , with practice and placebo run-ins .
METHODS	The primary outcome was change in executive functioning .
RESULTS	The intent to treat analysis was controlled for practice effects , comparing visits 1 and 2 to visits 5 and 6 for citalopram versus placebo .
RESULTS	There were no significant benefits on the executive function composite ( treatment-placebo mean difference -0.167 ; 95 % confidence interval [ CI ] , -0.361 to 0.028 ; P = .092 ) .
RESULTS	Citalopram participants showed improved clinician-rated depression symptoms on the HAM-D ( t = -2.02 ; P = 0.05 ) .
RESULTS	There were no group differences on motor ratings , self-reported executive functions , psychiatric symptoms , or functional status .
CONCLUSIONS	There was no evidence that short-term treatment with citalopram improved executive functions in HD .
CONCLUSIONS	Despite excluding patients with active depression , participants on citalopram showed improved mood , raising the possibility of efficacy for subsyndromal depression in HD .

###24334181
BACKGROUND	ACTG A5202 randomized treatment-nave individuals to tenofovir-emtricitabine ( TDF/FTC ) or abacavir-lamivudine ( ABC/3TC ) combined with efavirenz ( EFV ) or atazanavir/ritonavir ( ATV/r ) .
BACKGROUND	Individuals in the high screening viral load ( VL ) stratum ( 100,000 copies/mL ) had increased rates of virologic failure with ABC/3TC .
OBJECTIVE	To compare regimen-specific early virologic response .
METHODS	Using Wilcoxon rank-sum tests , we compared regimen-specific VL changes from entry to week 4 in A5202 subjects ( N = 1,813 ) and from entry to week 1 , 2 , and 4 in substudy subjects ( n = 179 ) .
METHODS	We evaluated associations between week 4 VL change and time to virologic failure with Cox proportional hazards models .
RESULTS	TDF/FTC and ABC/3TC produced similar week 4 VL declines in the entire study population and in the high VL stratum .
RESULTS	EFV produced greater VL declines from baseline at week 4 than ATV/r ( median -2.1 vs -1.9 log10 copies/mL ; P < .001 ) .
RESULTS	In the substudy of subjects with week 1 , 2 , and 4 VL data , there was no difference in VL decline in individuals randomized to TDF/FTC versus ABC/3TC , but EFV resulted in greater VL decline from entry at each of these timepoints than ATV/r .
RESULTS	Smaller week 4 VL decline was associated with increased risk of virologic failure .
CONCLUSIONS	Within all treatment arms , a less robust week 4 virologic response was associated with higher risk for subsequent virologic failure .
CONCLUSIONS	However , between-regimen differences in week 4 VL declines did not parallel the previously reported differences in longer term virologic efficacy in A5202 , suggesting that between-regimen differences in responses were not due to intrinsic differences in antiviral activity .

###25721551
OBJECTIVE	To investigate the efficacy and effects of transcranial direct current stimulation ( tDCS ) on motor imagery brain-computer interface ( MI-BCI ) with robotic feedback for stroke rehabilitation .
METHODS	A sham-controlled , randomized controlled trial .
METHODS	Patients recruited through a hospital stroke rehabilitation program .
METHODS	Subjects ( N = 19 ) who incurred a stroke 0.8 to 4.3 years prior , with moderate to severe upper extremity functional impairment , and passed BCI screening .
METHODS	Ten sessions of 20 minutes of tDCS or sham before 1 hour of MI-BCI with robotic feedback upper limb stroke rehabilitation for 2 weeks .
METHODS	Each rehabilitation session comprised 8 minutes of evaluation and 1 hour of therapy .
METHODS	Upper extremity Fugl-Meyer Motor Assessment ( FMMA ) scores measured end-intervention at week 2 and follow-up at week 4 , online BCI accuracies from the evaluation part , and laterality coefficients of the electroencephalogram ( EEG ) from the therapy part of the 10 rehabilitation sessions .
RESULTS	FMMA score improved in both groups at week 4 , but no intergroup differences were found at any time points .
RESULTS	Online accuracies of the evaluation part from the tDCS group were significantly higher than those from the sham group .
RESULTS	The EEG laterality coefficients from the therapy part of the tDCS group were significantly higher than those of the sham group .
CONCLUSIONS	The results suggest a role for tDCS in facilitating motor imagery in stroke .

###24354476
BACKGROUND	To date , the limited degrees of freedom ( DOF ) of most robotic training devices hinders them from providing functional training following stroke .
BACKGROUND	We developed a 6-DOF exoskeleton ( `` BONES '' ) that allows movement of the upper limb to assist in rehabilitation .
BACKGROUND	The objectives of this pilot study were to evaluate the impact of training with BONES on function of the affected upper limb , and to assess whether multijoint functional robotic training would translate into greater gains in arm function than single joint robotic training also conducted with BONES .
METHODS	Twenty subjects with mild to moderate chronic stroke participated in this crossover study .
METHODS	Each subject experienced multijoint functional training and single joint training three sessions per week , for four weeks , with the order of presentation randomized .
METHODS	The primary outcome measure was the change in Box and Block Test ( BBT ) .
METHODS	The secondary outcome measures were the changes in Fugl-Meyer Arm Motor Scale ( FMA ) , Wolf Motor Function Test ( WMFT ) , Motor Activity Log ( MAL ) , and quantitative measures of strength and speed of reaching .
METHODS	These measures were assessed at baseline , after each training period , and at a 3-month follow-up evaluation session .
RESULTS	Training with the robotic exoskeleton resulted in significant improvements in the BBT , FMA , WMFT , MAL , shoulder and elbow strength , and reaching speed ( p < 0.05 ) ; these improvements were sustained at the 3 month follow-up .
RESULTS	When comparing the effect of type of training on the gains obtained , no significant difference was noted between multijoint functional and single joint robotic training programs .
RESULTS	However , for the BBT , WMFT and MAL , inequality of carryover effects were noted ; subsequent analysis on the change in score between the baseline and first period of training again revealed no difference in the gains obtained between the types of training .
CONCLUSIONS	Training with the 6 DOF arm exoskeleton improved motor function after chronic stroke , challenging the idea that robotic therapy is only useful for impairment reduction .
CONCLUSIONS	The pilot results presented here also suggest that multijoint functional robotic training is not decisively superior to single joint robotic training .
CONCLUSIONS	This challenges the idea that functionally-oriented games during training is a key element for improving behavioral outcomes .
BACKGROUND	NCT01050231 .

###25099476
BACKGROUND	The aim of the present study was to compare vascular healing response between everolimus-eluting stent ( EES ) and biolimus-eluting stent ( BES ) using optical coherence tomography ( OCT ) .
RESULTS	In the NOBORI Biolimus-Eluting Versus XIENCE V/PROMUS Everolimus-Eluting Stent Trial ( NEXT ) , a formal OCT substudy investigated 91 patients ( 55 EES-treated lesions in 48 patients and 51 BES-treated lesions in 43 patients ) with 8-12 months follow-up imaging at 18 centers .
RESULTS	A total of 980 frames with 8,996 struts in EES and 907 frames with 8,745 struts in BES were analyzed .
RESULTS	Mean neointima thickness in EES and BES was 10582m and 9180m , respectively ( P < 0.001 ) .
RESULTS	With regard to stent-treated lesions , the percentage of struts not covered by neointima ( 37 % vs. 910 % , P < 0.001 ) and the frequency of stent-treated lesions with any uncovered struts ( n = 28 , 51 % vs. n = 42 , 82 % ; P < 0.001 ) were significantly lower in EES compared with BES .
RESULTS	In addition , the percentage of malapposed struts ( 0.20.8 % vs. 1.32.8 % , P = 0.006 ) and the frequency of stent-treated lesions with any malapposed struts ( n = 6 , 11 % vs. n = 14 , 27 % ; P = 0.028 ) were significantly lower in EES compared with BES .
CONCLUSIONS	Incomplete vascular healing characterized by the presence of struts not covered by neointima and malapposed struts was less common in EES compared with BES .

###25019968
OBJECTIVE	Pronase , a proteolytic enzyme , is known to improve mucosal visibility during esophagogastroduodenoscopy ( EGD ) , but little is known about its effects on gastric biopsy .
OBJECTIVE	This study assessed whether endoscopic flushing with pronase improves the quality of gastric biopsy .
METHODS	Consecutive patients who underwent EGD were randomly assigned to either the control group or the pronase group in a prospective setting .
METHODS	The first biopsy of the identified lesion was performed during endoscopy .
METHODS	Endoscopic flushing with either 50mL of water and dimethylpolysiloxane ( DMPS ; control group ) or 50mL of water , pronase , sodium bicarbonate , and DMPS ( pronase group ) was then applied to the lesion .
METHODS	After 5 minutes , the second biopsy was performed 2-3mm away from the first biopsy site .
METHODS	The thickness of mucus , depth of the specimen , overall diagnostic adequacy , anatomical orientation , and crush artifact were measured to assess the quality of the biopsy .
RESULTS	Of the 208 patients , 10 were not analyzed due to the absence of an identifiable lesion .
RESULTS	Compared with the control group , the pronase group showed significantly decreased thickness of mucus ( P < 0.001 ) , increased depth of biopsy ( P < 0.001 ) , improved anatomical orientation ( P = 0.010 ) , and improved overall diagnostic assessment ( P = 0.011 ) in the second biopsied specimen following endoscopic flushing .
RESULTS	The crush artifact and hemorrhage did not differ between the groups .
CONCLUSIONS	Endoscopic flushing with pronase not only improved the depth of biopsy but also the anatomical orientation and overall diagnostic adequacy .
CONCLUSIONS	Pronase can be recommended for flushing during EGD to improve the quantity and quality of biopsy .

###24467878
OBJECTIVE	The importance of adequate nutritional support is well established , but characterising what ` adequate nutrition ' represents remains contentious .
OBJECTIVE	In recent years there has been increasing interest in the concept of ` permissive underfeeding ' where patients are intentionally prescribed less nutrition than their calculated requirements .
OBJECTIVE	The aim of this study was to evaluate the effect of permissive underfeeding on septic and nutrition related morbidity in patients requiring short term parenteral nutrition ( PN ) .
METHODS	This was a single-blinded randomised clinical trial of 50 consecutive patients requiring parenteral nutritional support .
METHODS	Patients were randomized to receive either normocaloric or hypocaloric feeding ( respectively 100 % vs. 60 % of estimated requirements ) .
METHODS	The primary end point was septic complications .
METHODS	Secondary end points included the metabolic , physiological and clinical outcomes to the two feeding protocols .
RESULTS	Permissive underfeeding was associated with fewer septic complications ( 3 vs. 12 patients ; p = 0.003 ) , and a lower incidence of the systemic inflammatory response syndrome ( 9 vs. 16 patients ; p = 0.017 ) .
RESULTS	Permissively underfed patients had fewer feed related complications ( 2 vs. 9 patients ; p = 0.016 ) .
CONCLUSIONS	Permissive underfeeding in patients requiring short term PN appears to be safe and may results in reduced septic and feed-related complications .
BACKGROUND	NCT01154179 TRIAL REGISTRY : http://clinicaltrials.gov/ct2/show/NCT01154179 .

###24662288
BACKGROUND	Unlike conventional hemodialysis treatments , which rely almost solely on diffusion-related mechanisms for solute removal , hemodiafiltration ( HDF ) allows more efficient removal of higher molecular weight toxins due to convective transport mechanisms .
BACKGROUND	To facilitate the removal of these toxins in HDF treatment modalities , dialyzers with highly efficient high-flux membranes are necessary .
BACKGROUND	This study assessed the large uremic toxin removal ability of a high-flux dialyzer ( FX CorDiax 60 ) specifically designed to facilitate convective therapies compared with a standard high-flux dialyzer ( FX 60 ) .
METHODS	In an open , randomized , cross-over , single-center , controlled , prospective clinical study , 30 adult chronic hemodialysis patients were treated by post-dilution online HDF with the FX 60 or the FX CorDiax 60 dialyzer .
METHODS	All other dialysis parameters were kept constant in both study arms .
METHODS	The reduction rate ( RR ) of blood urea nitrogen , phosphate , 2-microglobulin ( 2-m ) , myoglobin , prolactin , 1-microglobulin , 1-acid glycoprotein , albumin and total protein as well as the elimination into dialysate was intraindividually compared for the two dialyzer types .
RESULTS	For FX CorDiax 60 versus FX 60 , the RR was significantly higher for blood urea nitrogen ( 86.23 4.14 vs. 84.89 4.59 % , p = 0.015 ) , 2-m ( 84.67 3.79 vs. 81.30 4.82 % , p < 0.0001 ) , myoglobin ( 75.23 10.48 vs. 58.60 12.1 % , p < 0.0001 ) , prolactin ( 72.96 9.68 vs. 56.91 13.01 % , p < 0.0001 ) and 1-microglobulin ( 20.89 18.27 vs. 13.60 12.50 % , p = 0.016 ) .
RESULTS	There were no significant differences in the RR for phosphate , 1-acid glycoprotein , albumin and total protein .
RESULTS	Mass removal was significantly higher with the FX CorDiax 60 than with the FX 60 for 2-m ( 0.26 0.09 vs. 0.24 0.09 g , p = 0.0006 ) , myoglobin ( 1.83 0.89 vs. 1.51 0.76 mg , p = 0.0017 ) , prolactin ( 0.17 0.13 vs. 0.14 0.08 mg , p = 0.02 ) and albumin ( 4.25 3.49 vs. 3.01 2.37 g , p = 0.03 ) .
CONCLUSIONS	This study demonstrates that treating patients with an FX CorDiax 60 instead of an FX 60 dialyzer in post-dilution HDF mode significantly increases the elimination of middle molecules .

###25095746
OBJECTIVE	Inflammation contributes to the development of peripheral artery disease ( PAD ) and may contribute to intermittent claudication by adversely affecting vascular and skeletal muscle function .
OBJECTIVE	We explored the association of inflammation to maximal walking time ( MWT ) in patients with claudication .
METHODS	Circulating inflammatory biomarkers , including tumor necrosis factor ( TNF - ) , C-reactive protein ( CRP ) , interleukin-6 ( IL-6 ) , and soluble intercellular adhesion molecule 1 ( sICAM ) , were measured in 75 subjects with intermittent claudication as well as in 43 healthy subjects .
METHODS	Real-time polymerase chain reaction was used to quantify mRNA expression of TNF - , IL-6 , interferon - , and CD36 from peripheral blood monocytes .
METHODS	Treadmill testing was performed in PAD subjects to assess MWT .
RESULTS	Compared with healthy subjects , PAD subjects had higher levels of circulating TNF - ( P < .0001 ) , CRP ( P = .003 ) , sICAM ( P < .0001 ) , and IL-6 ( P < .0001 ) .
RESULTS	Expression of both IL-6 ( P = .024 ) and CD36 ( P = .018 ) was greater in PAD subjects than in healthy subjects .
RESULTS	Among subjects with PAD , higher gene expression of TNF - was associated inversely with MWT ( P = .01 ) .
RESULTS	MWT was also associated inversely with greater levels of circulating TNF - ( P = .028 ) , CRP ( P = .024 ) , IL-6 ( P = .03 ) , and sICAM ( P = .018 ) .
CONCLUSIONS	Systemic inflammation , as indicated by TNF - inflammatory gene expression in peripheral blood monocytes and by circulating biomarker levels , is associated with impairment in walking time in patients with PAD and intermittent claudication .

###25204676
BACKGROUND	Weight gain and obesity are common after kidney transplantation , particularly during the first year .
BACKGROUND	Obesity is a risk factor for the development of new-onset diabetes after transplantation , and is associated with reduced graft survival .
BACKGROUND	There is a lack of evidence for effective interventions to prevent weight gain after kidney transplantation .
METHODS	The effect of INTEnsive Nutrition interventions on weight gain after kidney Transplantation ( INTENT ) trial is a single-blind ( outcomes assessor ) , randomised controlled trial to assess the effect of intensive nutrition interventions , including exercise advice , on weight gain and metabolic parameters in the first year after transplantation .
METHODS	Participants will be randomised during the first post-transplant month to either standard care ( four visits with a renal dietitian over twelve months ) or intensive nutrition intervention ( eight visits with a renal dietitian over the first six months , four visits over the second six months , and three visits over the first six months with an exercise physiologist ) .
METHODS	In the intensive intervention group , nutrition counselling will be provided using motivational interviewing techniques to encourage quality engagement .
METHODS	Collaborative goal setting will be used to develop personalised nutrition care plans .
METHODS	Individualised advice regarding physical activity will be provided by an exercise physiologist .
METHODS	The primary outcome of the study is weight at six months after transplant , adjusted for baseline ( one month post-transplant ) weight , obesity and gender .
METHODS	Secondary outcomes will include changes in weight and other anthropometric measures over 12 months , body composition ( in vivo neutron activation analysis , total body potassium , dual-energy X-ray absorptiometry , and bioelectrical impedance ) , biochemistry ( fasting glucose , lipids , haemoglobin A1c and insulin ) , dietary intake and nutritional status , quality of life , and physical function .
CONCLUSIONS	There are currently few randomised clinical trials of nutrition interventions after kidney transplantation .
CONCLUSIONS	The INTENT trial will thus provide important data on the effect of intensive nutrition interventions on weight gain after transplant and the associated metabolic consequences .
CONCLUSIONS	Additionally , by assessing changes in glucose metabolism , the study will also provide data on the feasibility of undertaking larger multi-centre trials of nutrition interventions to reduce the incidence or severity of diabetes after transplantation .
BACKGROUND	Australian New Zealand Clinical Trials Registry Number : ACTRN12614000155695 .

###25193157
BACKGROUND	Between 40,000 and 80,000 pregnant women die annually from pre-eclampsia and eclampsia .
BACKGROUND	Although magnesium sulphate and anti-hypertensive therapies can reduce the morbidity and mortality associated with pre-eclampsia , the only cure comes with delivery .
BACKGROUND	Prompt delivery of the baby , preferably by vaginal route , is vital in order to achieve good maternal and neonatal outcomes .
BACKGROUND	Induction of labour is therefore a critical intervention in order to prevent morbidity to both mother and baby .
BACKGROUND	Two low cost interventions - oral misoprostol tablets and transcervical Foley catheterization - are already used by some in low resource settings , but their relative risks and benefits are not known .
BACKGROUND	The trial will compare the risks , benefits , and trade-offs in efficacy , safety , acceptability and cost of misoprostol and Foley catheter for induction in women with preeclampsia or uncontrolled hypertension .
METHODS	A total of 602 women with an ongoing pregnancy with a live fetus requiring delivery because of pre-eclampsia or uncontrolled hypertension will be randomly assigned to labor induction with a transcervical Foley catheter or oral misoprostol 25 micrograms .
METHODS	Women will be recruited at two hospitals in Nagpur , India .
METHODS	The misoprostol group will receive oral misoprostol 25 microgram every 2 hours for a maximum of 12 doses or until active labor commences .
METHODS	The Foley group will undergo induction using a Foley catheter ( silicone , size 18 F with 30 ml balloon ) which will remain until active labor starts , the Foley catheter falls out , or 12 hours have elapsed .
METHODS	The primary outcome will be the attainment of vaginal delivery within 24 hours .
METHODS	Providers administering the treatment and those assessing the outcomes will not be blinded to group assignment .
BACKGROUND	NCT01801410 ( ClinicalTrials.gov ) .

###24532352
BACKGROUND	Tobacco cessation treatments have not been evaluated among Alaska Native ( AN ) adolescents .
BACKGROUND	This pilot study evaluated the feasibility and the potential efficacy of a targeted cessation intervention for AN youth using a group randomized design .
METHODS	Eight villages in western Alaska were randomly assigned to receive the intervention ( n = 4 villages ) or a delayed treatment control condition ( written materials only ; n = 4 villages ) .
METHODS	Ten adolescents aged 12-17 years were targeted from each village with a planned enrollment of 80 .
METHODS	The intervention was held over a weekend , and youth traveled from their villages to quit tobacco use with other teens .
METHODS	The intervention comprised 8 hr of group-based counseling .
METHODS	Talking circles , personal stories from elders , and recreational activities were included to enhance cultural acceptability and participation .
METHODS	Newsletters were mailed weekly for 5-weeks postprogram .
METHODS	Assessments were conducted at baseline , week 6 ( end-of-treatment ) , and 6 months .
METHODS	Self-reported tobacco abstinence was confirmed with salivary cotinine .
RESULTS	Recruitment targets were met in the intervention ( 41 enrolled ) but not in control villages ( 27 enrolled ) .
RESULTS	All intervention participants attended the weekend program .
RESULTS	Retention was high ; 98 % of intervention and 86 % of control participants completed 6-month follow-up .
RESULTS	The 7-day point-prevalence self-reported tobacco abstinence rates for intervention and control participants were 10 % ( 4/41 ) and 0 % ( 0/27 ) at both week 6 and 6 months ( p = .15 ) .
RESULTS	Only 1 adolescent in the intervention condition was biochemically confirmed abstinent at week 6 and none at 6 months .
CONCLUSIONS	The intensive individual-focused intervention used in this study was feasible but not effective for tobacco cessation among AN youth .
CONCLUSIONS	Alternative approaches are warranted .

###25122097
OBJECTIVE	The aim of this study was to verify the effects of loaded exercises associated with a task-oriented training ( TOT ) program in the recovery of upper-limb function in individuals with chronic hemiparesis after stroke .
METHODS	This study used a single-blinded , randomized controlled trial .
METHODS	Patients were included into two TOT groups : one that performed the task-oriented therapy without load ( TOT group , n = 10 ) and another one that performed task-oriented therapy with personalized resistance ( TOT_ST group , n = 10 ) for 6 wks , for a total of 12 sessions .
METHODS	Main measures included The Upper Extremity Performance Test , shoulder flexor and handgrip strength , shoulder active range of motion , motor impairment ( Fugl-Meyer Scale ) , and muscle tone .
RESULTS	The TOT_ST group demonstrated better scores relating to unilateral tasks and in the quality aspects of bilateral movements ( The Upper Extremity Performance Test , P = 0.04 ) at the end of rehabilitation protocol .
RESULTS	The highest muscle force gain was reached by the TOT_ST group for the shoulder flexors ( P = 0.001 ) .
RESULTS	Similarly , the active range of motion ( P = 0.01 ) and Fugl-Meyer scores ( P = 0.001 ) were higher in the TOT_ST group compared with the TOT group .
RESULTS	Both groups showed improvement after training .
CONCLUSIONS	Strength training was able to intensify the upper-limb rehabilitation , as demonstrated by the superior scores achieved by the TOT_ST group in most of the evaluated parameters .
CONCLUSIONS	Muscle strength training might be a pivotal element of the task-oriented rehabilitation program of chronic patients with mild impairment after stroke .

###25056655
BACKGROUND	Constipation is a frequent complaint and the combination of a prebiotic and probiotics could have a potentially synergic effect on the intestinal transit .
BACKGROUND	The present study therefore aims to investigate the combination of polydextrose ( Litesse ) , L. acidophilus NCFM and B. lactis HN019 in a yogurt on intestinal transit in subjects who suffer from constipation .
METHODS	Patients with constipation were randomly divided into two groups , Control Group ( CG ) and Treatment Group ( TG ) , and had to eat 180 ml of unflavored yogurt every morning for 14 days .
METHODS	Those in the CG received only yogurt , while the TG received yogurt containing polydextrose , L. acidophilus NCFM ( ATCC 700396 ) and B. lactis HN019 ( AGAL NM97/09513 ) .
RESULTS	Favourable clinical response was assessed since Agachan score had a significant reduction at the end of the study in both groups and tended to be better in the TG .
RESULTS	The subjects in the treatment group also had a shorter transit time at the end of the intervention compared to the control group ( p = 0.01 ) .
CONCLUSIONS	The product containing yogurt with polydextrose , B. lactis HN019 and L. acidophilus NCFM significantly shortened colonic transit time after two weeks in the TG compared to CG and may be an option for treatment of constipation .

###24935203
BACKGROUND	Hepatocellular carcinoma ( HCC ) is a primary tumor of the liver with poor prognosis .
BACKGROUND	For early stage HCC , treatment options include surgical resection , liver transplantation , and percutaneous ablation .
BACKGROUND	Percutaneous ablative techniques ( radiofrequency and microwave techniques ) emerged as best therapeutic options for nonsurgical patients .
OBJECTIVE	We aimed to determine the safety and efficacy of radiofrequency and microwave procedures for ablation of early stage HCC lesions and prospectively follow up our patients for survival analysis .
METHODS	One Hundred and 11 patients with early HCC are managed in our multidisciplinary clinic using either radiofrequency or microwave ablation .
METHODS	Patients are assessed for efficacy and safety .
METHODS	Complete ablation rate , local recurrence , and overall survival analysis are compared between both procedures .
RESULTS	Radiofrequency ablation group ( n = 45 ) and microwave ablation group ( n = 66 ) were nearly comparable as regards the tumor and patients characteristics .
RESULTS	Complete ablation was achieved in 94.2 and 96.1 % of patients managed by radiofrequency and microwave ablation techniques , respectively ( p value 0.6 ) with a low rate of minor complications ( 11.1 and 3.2 , respectively ) including subcapsular hematoma , thigh burn , abdominal wall skin burn , and pleural effusion .
RESULTS	Ablation rates did not differ between ablated lesions 3 and 3-5 cm .
RESULTS	A lower incidence of local recurrence was observed in microwave group ( 3.9 vs. 13.5 % in radiofrequency group , p value 0.04 ) .
RESULTS	No difference between both groups as regards de novo lesions , portal vein thrombosis , and abdominal lymphadenopathy .
RESULTS	The overall actuarial probability of survival was 91.6 % at 1 year and 86.1 % at 2 years with a higher survival rates noticed in microwave group but still without significant difference ( p value 0.49 ) .
CONCLUSIONS	Radiofrequency and microwave ablations led to safe and equivalent ablation and survival rates ( with superiority for microwave ablation as regards the incidence of local recurrence ) .

###24320723
BACKGROUND	Cooking with Kids ( CWK ) , an experiential school-based food education program , has demonstrated modest influence on fruit and vegetable preference , food and cooking attitudes ( AT ) , and self-efficacy ( SE ) among fourth-grade , mostly low-income Hispanic students in a quasiexperimental study with an inconsistent baseline .
BACKGROUND	Effect was notably strong for boys and those without previous cooking experience .
BACKGROUND	The aim of this project was to assess the effect of CWK with a mostly non-Hispanic white sample that assured no previous CWK exposure .
METHODS	The randomized , controlled assessment of CWK effect on fourth graders was conducted with 257 students in 12 classes in four public schools .
METHODS	CWK included a 1-hour introductory lesson , three 2-hour cooking classes , and three 1-hour fruit and vegetable tasting sessions led by trained food educators during the school day for one semester .
METHODS	Fruit preference , vegetable preference , and cooking AT and SE were assessed with a tested 35-item measure , shown to have test-retest reliability .
METHODS	Univariate analyses considered gender and previous cooking experience .
RESULTS	Intervention efficacy was confirmed in this mostly white sample ( 75 % ; 79 % with previous cooking experience ; 54 % girls ) .
RESULTS	Increases in vegetable preference , AT , and SE were all significantly greater in CWK students with p ( 2 ) of 0.03 , 0.02 , and 0.06 , respectively .
RESULTS	CWK most strongly improved AT and SE for boys without previous cooking experience .
CONCLUSIONS	CWK significantly improved fourth-grade students ' vegetable preferences , AT , and SE toward food and cooking , which are factors important to healthful eating and obesity prevention .
CONCLUSIONS	Noncookers , especially boys , benefitted from this intervention .

###24625583
BACKGROUND	Buruli Ulcer ( BU ) is a tropical infectious skin disease that is currently treated with 8 weeks of intramuscular streptomycin and oral rifampicin .
BACKGROUND	As prolonged streptomycin administration can cause both oto - and nephrotoxicity , we evaluated its long term toxicity by following-up former BU patients that had received either 4 or 8 weeks of streptomycin in addition to other drugs between 2006 and 2008 , in the context of a randomized controlled trial .
METHODS	Former patients were retrieved in 2012 , and oto - and nephrotoxicity were determined by audiometry and serum creatinine levels .
METHODS	Data were compared with baseline and week 8 measurements during the drug trial .
RESULTS	Of the total of 151 former patients , 127 ( 84 % ) were retrieved .
RESULTS	Ototoxicity was present in 29 % of adults and 25 % of children .
RESULTS	Adults in the 8 week streptomycin group had significantly higher hearing thresholds in all frequencies at long term follow-up , and these differences were most prominent in the high frequencies .
RESULTS	In children , no differences between the two treatment arms were found .
RESULTS	Nephrotoxicity that had been detected in 14 % of adults and in 13 % of children during treatment , was present in only 2.4 % of patients at long term follow-up .
CONCLUSIONS	Prolonged streptomycin administration in the adult study subjects caused significant persistent hearing loss , especially in the high frequency range .
CONCLUSIONS	Nephrotoxicity was also present in both adults and children but appeared to be transient .
CONCLUSIONS	Streptomycin should be given with caution especially in patients aged 16 or older , and in individuals with concurrent risks for renal dysfunction or hearing loss .

###25262378
BACKGROUND	Basal cell carcinoma ( BCC ) is the most common form of cancer among Caucasians and its incidence continues to rise .
BACKGROUND	Surgical excision ( SE ) is considered standard treatment , though randomised trials with long-term follow-up are rare .
BACKGROUND	We now report the long-term results of a randomised trial comparing surgical excision with Mohs ' micrographic surgery ( MMS ) for facial BCC .
METHODS	408 facial , high risk ( diameter at least 1cm , H-zone location or aggressive histological subtype ) primary BCCs ( pBCCs ) and 204 facial recurrent BCCs ( rBCCs ) were randomly allocated to treatment with either SE or MMS between 5th October 1999 and 27th February 2002 .
METHODS	The primary outcome was recurrence of carcinoma .
METHODS	A modified intention to treat analysis was performed .
RESULTS	For primary BCC , the 10-year cumulative probabilities of recurrence were 4.4 % after MMS and 12.2 % after SE ( Log-rank test ( 2 ) 2.704 , p = 0.100 ) .
RESULTS	For recurrent BCC , cumulative 10-year recurrence probabilities were 3.9 % and 13.5 % for MMS and SE , respectively ( Log-rank ( 2 ) 5.166 , p = 0.023 ) .
RESULTS	A substantial proportion of recurrences occurred after more than 5years post-treatment : 56 % for pBCC and 14 % for rBCC .
CONCLUSIONS	Fewer recurrences occurred after treatment of high risk facial BCC with MMS compared to treatment with SE .
CONCLUSIONS	The proportion of recurrences occurring more than 5years post-treatment was especially high for pBCC , stressing the need for long-term follow-up in patients with high risk facial pBCC .

###26227096
OBJECTIVE	To evaluate the pharmacokinetic and pharmacodynamic ( PK/PD ) results of three different infusion time regimens of single doses of 600 mg linezolid in healthy Han Chinese volunteers .
METHODS	We conducted a clinical trial involving 6 male and 6 female healthy Chinese volunteers .
METHODS	They were randomized to receive intravenous linezolid infusion ( 600 mg/0 .5 hours , 600 mg/2 hours , or 600 mg/4 hours ) in three periods with washout periods of 7 days between each dosage .
METHODS	Serum linezolid concentration was measured in each subject at pre-dose ( at 0 hours ) until 24 hours after each dose .
METHODS	The ratio of the area under the serum concentration-time curve ( AUC ) to the minimum inhibitory concentration ( MIC ) , AUC/MIC , was adopted as the major relevant parameter .
METHODS	Monte Carlo simulation was used to evaluate the probability of target attainment ( PTA ) of these three linezolid regimens .
RESULTS	One subject in 600 mg/0 .5 hours regimen complained of mild pain at the injection site .
RESULTS	No significant difference was found in pharmacokinetic parameters among the three different infusion regimens .
RESULTS	When AUC/MIC was applied as parameter , PTA of 4 hours infusion regimen was much lower than that of the 0.5 hours and 2 hours infusion regimens ( 55.65 % vs. 74.91 % and 72.03 % , respectively ) .
RESULTS	Especially at higher MIC ( 2 g/mL ) , the PTAs of the 0.5 hours and 2 hours infusion regimens decreased to 57.2 % and 50.1 % , respectively , while that of the 4 hours infusion regimen dropped sharply to only 25.95 % .
RESULTS	When T > MIC was applied as a parameter , PTA of the 0.5 hours regimen was higher than 90 % , while the 2 hours and 4 hours regimens remained 100 % .
CONCLUSIONS	Our findings suggest that 2 hours infusion of linezolid at a fixed dose ( 600 mg ) regimen is appropriate to achieve the safety and efficacy against MRSA-caused infections in Chinese adults .

###25209926
OBJECTIVE	To evaluate the effectiveness of 200 mg of daily vaginal natural progesterone to prevent preterm birth in women with preterm labour .
METHODS	Multicentre , randomised , double-blind , placebo-controlled trial .
METHODS	Twenty-nine centres in Switzerland and Argentina .
METHODS	A total of 385 women with preterm labour ( 24 ( 0/7 ) to 33 ( 6/7 ) weeks of gestation ) treated with acute tocolysis .
METHODS	Participants were randomly allocated to either 200 mg daily of self-administered vaginal progesterone or placebo within 48 hours of starting acute tocolysis .
METHODS	Primary outcome was delivery before 37 weeks of gestation .
METHODS	Secondary outcomes were delivery before 32 and 34 weeks , adverse effects , duration of tocolysis , re-admissions for preterm labour , length of hospital stay , and neonatal morbidity and mortality .
METHODS	The study was ended prematurely based on results of the intermediate analysis .
RESULTS	Preterm birth occurred in 42.5 % of women in the progesterone group versus 35.5 % in the placebo group ( relative risk [ RR ] 1.2 ; 95 % confidence interval [ 95 % CI ] 0.93-1 .5 ) .
RESULTS	Delivery at < 32 and < 34 weeks did not differ between the two groups ( 12.9 versus 9.7 % ; [ RR 1.3 ; 95 % CI 0.7-2 .5 ] and 19.7 versus 12.9 % [ RR 1.5 ; 95 % CI 0.9-2 .4 ] , respectively ) .
RESULTS	The duration of tocolysis , hospitalisation , and recurrence of preterm labour were comparable between groups .
RESULTS	Neonatal morbidity occurred in 44 ( 22.8 % ) cases on progesterone versus 35 ( 18.8 % ) cases on placebo ( RR : 1.2 ; 95 % CI 0.82-1 .8 ) , whereas there were 4 ( 2 % ) neonatal deaths in each study group .
CONCLUSIONS	There is no evidence that the daily administration of 200 mg vaginal progesterone decreases preterm birth or improves neonatal outcome in women with preterm labour .

###25454965
BACKGROUND	Competency-based education and simulation are being used more frequently in surgical skills curricula .
BACKGROUND	We explored a novel student-led learning paradigm , which allows trainees to become more active participants in the learning process while maintaining expert guidance and supervision .
METHODS	Twelve first-year orthopedic residents were randomized to either a student-led ( SL ) or a traditional instructor-led group during an intensive , month-long , laboratory-based technical skills training course .
METHODS	A rigorous qualitative-description approach was used for analysis .
RESULTS	Four prominent themes emerged : instructional style , feedback , peer and instructor collaboration , and self-efficacy .
RESULTS	Compared with the instructor-led group , there was more peer assistance , feedback , collaboration , and hands-on and active learning observed in the SL group .
CONCLUSIONS	The flexible and socially rich nature of the SL learning environment may aid in development of both technical and nontechnical skills early in residency and ultimately privilege later clinical learning .

###25212521
BACKGROUND	A low-cost virtual reality system that translates movements of the hand , fingers , and thumb into game play was designed to provide a flexible and motivating approach to increasing adherence to home-based rehabilitation .
OBJECTIVE	Effectiveness depends on adherence , so did patients use the intervention to the recommended level ?
OBJECTIVE	If not , what reasons did they give ?
OBJECTIVE	The purpose of this study was to investigate these and related questions .
METHODS	A prospective cohort study , plus qualitative analysis of interviews , was conducted .
METHODS	Seventeen patients recovering from stroke recruited to the intervention arm of a feasibility trial had the equipment left in their homes for 8 weeks and were advised to use it 3 times a day for periods of no more than 20 minutes .
METHODS	Frequency and duration of use were automatically recorded .
METHODS	At the end of the intervention , participants were interviewed to determine barriers to using it in the recommended way .
RESULTS	Duration of use and how many days they used the equipment are presented for the 13 participants who successfully started the intervention .
RESULTS	These figures were highly variable and could fall far short of our recommendations .
RESULTS	There was a weak positive correlation between duration and baseline reported activities of daily living .
RESULTS	Participants reported lack of familiarity with technology and competing commitments as barriers to use , although they appreciated the flexibility of the intervention and found it motivating .
CONCLUSIONS	The small sample size limits the conclusions that can be drawn .
CONCLUSIONS	Level of use is variable and can fall far short of recommendations .
CONCLUSIONS	Competing commitments were a barrier to use of the equipment , but participants reported that the intervention was flexible and motivating .
CONCLUSIONS	It will not suit everyone , but some participants recorded high levels of use .
CONCLUSIONS	Implications for practice are discussed .

###25339455
OBJECTIVE	To determine the effect of choice of inhalational anaesthetic ( sevoflurane vs propofol ) on the incidence and severity of postoperative cognitive dysfunction ( POCD ) in elderly patients ( aged 60 years ) with mild cognitive impairment ( MCI ) .
METHODS	Elderly patients with MCI undergoing radical rectal resection were randomly assigned to receive sevoflurane or propofol general anaesthesia .
METHODS	Cognitive function was assessed using neuropsychological testing before and 7 days after surgery .
METHODS	POCD severity was graded as mild , moderate or severe using standard deviation cut-offs .
RESULTS	At 7 days after surgery , the incidence of POCD was 29.7 % in the propofol group ( n = 101 ) and 33.3 % in the sevoflurane group ( n = 99 ) .
RESULTS	There was a signicant between-group difference for POCD severity : sevoflurane anaesthesia had a more severe impact on cognitive function than propofol anaesthesia .
CONCLUSIONS	There was no difference in the incidence of POCD at 7 days after radical rectal resection under sevoflurane or propofol-based general anaesthesia .
CONCLUSIONS	Both propofol and sevoflurane were associated with negative cognitive effects , but sevoflurane had a more severe impact on cognitive function than propofol , in elderly patients with MCI .

###24438599
OBJECTIVE	To compare the safety and efficacy of sedation induced by dexmedetomidine and propofol after oral and maxillofacial surgery .
METHODS	In this trial , 66 patients 18 to 50 years old received oral and maxillofacial surgery and required postoperative nasal endotracheal intubation under overnight sedation with dexmedetomidine or propofol .
METHODS	The dexmedetomidine group ( group D ) received dexmedetomidine 1.0 g/kg intravenously for 10 minutes after entering the recovery room .
METHODS	The dose was maintained by giving an intravenous injection of dexmedetomidine 0.4 g/kg .
METHODS	The injection rate could be modulated from 0.2 to 0.7 g/kg/hour in the intensive care unit ( ICU ) .
METHODS	If the Ramsay score was lower than 2 and involuntary limb movement occurred , other sedatives were used .
METHODS	The propofol group ( group P ) was given propofol 0.1 mg/kg intravenously for 10 minutes after entering the recovery room and then maintained with intravenous injections of propofol 1 to 2 mg/kg/hour in the recovery room and ICU .
RESULTS	The oxygen desaturation of group P was higher than that of group D ( at the first sedation time of 30 minutes ) , but the mean blood pressure of group P was significantly lower than that of group D at the 10-minute time point .
RESULTS	The Ramsay score was higher in group D after the first 3 hours of sedation than in group P ( P < .05 ) .
CONCLUSIONS	Dexmedetomidine showed similar safety and efficacy as propofol and could be used for tube-retaining sedation after oral and maxillofacial surgery .

###25129520
OBJECTIVE	This study sought to prospectively study the impact of an appropriate use criteria ( AUC ) - based educational intervention on outpatient transthoracic echocardiography ( TTE ) ordering by physicians-in-training .
BACKGROUND	AUC were developed in response to concerns about inappropriate utilization .
BACKGROUND	It is unknown whether an educational intervention can reduce inappropriate outpatient TTE .
METHODS	We conducted a randomized control trial in which physicians-in-training were randomized to an AUC-based educational intervention or a control group at an academic medical center in Boston , Massachusetts .
METHODS	The primary endpoints were the rates of inappropriate and appropriate TTE .
RESULTS	For the cardiology physicians-in-training , the proportion of inappropriate TTE was significantly lower in the intervention than in the control group ( 13 % vs. 34 % , p < 0.001 ) .
RESULTS	As a corollary , the proportion of appropriate TTE ordered by the intervention group was significantly higher than that of the control group ( 81 % vs. 58 % , p < 0.001 ) .
RESULTS	The odds of ordering an appropriate TTE in the cardiology intervention group was 2.7 ( 95 % confidence interval [ CI ] : 1.5 to 5.1 , p = 0.002 ) relative to the control group .
RESULTS	The internal medicine physicians-in-training ordered a small number of TTE overall , and there was a trend toward significant odds of ordering an appropriate TTE in the intervention group relative to the control group ( odds ratio [ OR ] : 8.1 , 95 % CI : 0.95 to 69.0 , p = 0.055 ) .
RESULTS	Six clinical scenarios accounted for 75 % of all inappropriate TTE , with the 3 most common inappropriate indications being routine surveillance ( < 1 year ) of known cardiomyopathy without a change in clinical status , routine surveillance of known small pericardial effusion , and routine surveillance of ventricular function with known coronary artery disease and no change in clinical status .
CONCLUSIONS	In cardiology fellows with a high rate of ordering inappropriate TTE , an AUC-based educational and feedback intervention reduced the proportion of inappropriate outpatient TTE and increased the proportion of appropriate outpatient TTE .
CONCLUSIONS	( Educational Intervention to Reduce Outpatient Inappropriate Transthoracic Echocardiograms ; NCT01944202 ) .

###25525354
BACKGROUND	In patients receiving inhaled medication , dissatisfaction with and difficulty in using the inhaler can affect treatment adherence .
BACKGROUND	The incidence of handling errors is typically higher in the elderly than in younger people .
BACKGROUND	The aim of the study was to assess inhaler preference for and handling errors with the ELLIPTA dry powder inhaler ( DPI ) , ( GSK ) , compared with the established BREEZHALER , a single-dose capsule DPI ( Novartis ) , in inhalation device-nave Japanese volunteers aged 40 years .
METHODS	In this open-label , nondrug interventional , crossover DPI preference study comparing the ELLIPTA DPI and BREEZHALER , 150 subjects were randomized to handle the ELLIPTA or BREEZHALER DPIs until the point of inhalation , without receiving verbal or demonstrative instruction ( first attempt ) .
METHODS	Subjects then crossed over to the other inhaler .
METHODS	Preference was assessed using a self-completed questionnaire .
METHODS	Inhaler handling was assessed by a trained assessor using a checklist .
METHODS	Subjects did not inhale any medication in the study , so efficacy and safety were not measured .
RESULTS	The ELLIPTA DPI was preferred to the BREEZHALER by 89 % of subjects ( odds ratio [ OR ] 70.14 , 95 % confidence interval [ CI ] 33.69-146 .01 ; P-value not applicable for this inhaler ) for ease of use , by 63 % of subjects ( OR 2.98 , CI 1.87-4 .77 ; P < 0.0001 ) for ease of determining the number of doses remaining in the inhaler , by 91 % for number of steps required , and by 93 % for time needed for handling the inhaler .
RESULTS	The BREEZHALER was preferred to the ELLIPTA DPI for comfort of the mouthpiece by 64 % of subjects ( OR 3.16 , CI 1.97-5 .06 ; P < 0.0001 ) .
RESULTS	The incidence of handling errors ( first attempt ) was 11 % with ELLIPTA and 68 % with BREEZHALER ; differences in incidence were generally similar when analyzed by age ( < or 65 years ) or sex .
CONCLUSIONS	These data , obtained in an inhalation device-nave population , suggest that the ELLIPTA DPI is preferred to an established alternative based on its ease-of-use features and is associated with fewer handling errors .

###24554737
OBJECTIVE	To compare the clinical results and the intraoperative and postoperative performance of an additional sulcus-fixated multifocal intraocular lens ( IOL ) with a conventional multifocal IOL implanted in the capsular bag .
METHODS	In this prospective , randomised , monocentric study , the intraoperative and postoperative outcomes after implantation of an additional sulcus-fixated multifocal IOL ( group A ; 29 eyes ) and a conventional , multifocal posterior chamber IOL ( group B ; 25 eyes ) are compared .
METHODS	1-year postoperatively , visual acuity , contrast sensitivity and defocus curve were determined .
METHODS	Patients implanted bilaterally with the same IOL filled in a questionnaire to assess patient satisfaction .
RESULTS	Between the groups , only slight differences were found in visual acuity at all distances .
RESULTS	All patients achieved an uncorrected distance visual acuity of 0.1 LogMAR or better and an uncorrected intermediate/near visual acuity of 0.3 LogMAR or better .
RESULTS	Slightly better results in contrast sensitivity were achieved in group A at high spatial frequencies under almost all lighting conditions .
RESULTS	Patient survey showed a higher degree of satisfaction of patients in group B , while a smaller proportion of group A stated to have disturbing light phenomena .
CONCLUSIONS	Only small functional differences between the examined methods were found .
CONCLUSIONS	Both types of multifocal IOL performed well at all distances .
CONCLUSIONS	There were no intraoperative and postoperative complications in the add-on IOL group which affirms the high safety level such as with conventional multifocal IOL in the capsular bag .

###24952392
OBJECTIVE	We performed a pooled analysis based on patient-level data from the TITAX-AMI and BASE-ACS trials to evaluate the outcome of titanium-nitride-oxide-coated bioactive stents vs drug-eluting stents in patients with ST-segment elevation myocardial infarction at 2-year follow-up .
METHODS	The TITAX-AMI trial compared bioactive stents with paclitaxel-eluting stents in 425 patients with acute myocardial infarction .
METHODS	The BASE-ACS trial compared bioactive stents with everolimus-eluting stents in 827 patients with acute coronary syndrome .
METHODS	The primary endpoint for the pooled analysis was major adverse cardiac events : a composite of cardiac death , recurrent myocardial infarction , or ischemia-driven target lesion revascularization at 2-year follow-up .
RESULTS	The pooled analysis included 501 patients ; 245 received bioactive stents , and 256 received drug-eluting stents .
RESULTS	The pooled bioactive stent group was associated with a risk ratio of 0.85 for major adverse cardiac events ( 95 % confidence interval , 0.53-1 .35 ; P = .49 ) compared to the pooled drug-eluting stent group .
RESULTS	Similarly , the pooled bioactive stent group was associated with a risk ratio of 0.71 for cardiac death ( 95 % confidence interval , 0.26-1 .95 ; P = .51 ) , 0.44 for recurrent myocardial infarction ( 95 % confidence interval , 0.20-0 .97 ; P = .04 ) , and 1.39 for ischemia-driven target lesion revascularization ( 95 % confidence interval , 0.74-2 .59 ; P = .30 ) , compared to the pooled drug-eluting stent group .
RESULTS	These results were confirmed by propensity-score adjusted analysis of the combined datasets .
CONCLUSIONS	In patients with ST-segment elevation myocardial infarction , bioactive stents were associated with lower rates of recurrent myocardial infarction compared to drug-eluting stents at 2-year follow-up ; yet , the rates of cardiac death and ischemia-driven target lesion revascularization were similar .

###24828268
BACKGROUND	Dissemination of research results to study participants and stakeholders and provision of proven effective products in the immediate post-trial period are core elements of the conduct of biomedical HIV prevention clinical trials .
BACKGROUND	Few biomedical HIV prevention trials have demonstrated HIV protection with novel interventions , and thus , communication of positive trial results and provision of an effective product have not been tested in many situations .
METHODS	In July 2011 , the independent Data and Safety Monitoring Board of the Partners PrEP Study , a randomized , placebo-controlled efficacy trial of daily oral antiretroviral preexposure prophylaxis ( PrEP ) for HIV prevention among 4747 African heterosexual HIV serodiscordant couples , recommended discontinuation of the trial 's placebo arm due to demonstration of PrEP efficacy .
METHODS	We describe dissemination of results , discontinuation of the placebo arm , and provision of active PrEP to participants ' formerly assigned placebo .
RESULTS	Within 72 hours , of the Data and Safety Monitoring Board meeting the study results were publicly released and disseminated to stakeholders and study participants .
RESULTS	Within 3 months , the study protocol was modified to permit participants initially assigned to the study 's placebo arm to be offered active PrEP .
RESULTS	Of the 1418 participants initially randomized to placebo who were clinically eligible to receive PrEP , 89.1 % ( 1264/1418 ) consented .
CONCLUSIONS	Prompt dissemination of a positive HIV prevention trial result and subsequent provision of effective product to research participants was feasible and efficient for > 4700 HIV serodiscordant couples in East Africa .
CONCLUSIONS	The extent to which study sponsors can assure continued product access to research participants remains a subject of discussion for future HIV prevention clinical trials .

###24257741
OBJECTIVE	To evaluate the heating and magnetic field interactions of fixed orthodontic appliances with different wires and ligaments in a 3-T MRI environment and to estimate the safety of these orthodontic materials .
METHODS	40 non-carious extracted human maxillary teeth were embedded in polyvinyl chloride boxes , and orthodontic brackets were bonded .
METHODS	Nickel-titanium and stainless steel arch wires , and elastic and stainless steel ligaments were used to obtain four experimental groups in total .
METHODS	Specimens were evaluated at 3T for radiofrequency heating and magnetic field interactions .
METHODS	Radiofrequency heating was evaluated by placing specimens in a cylindrical plastic container filled with isotonic solution and measuring changes in temperature after T1 weighted axial sequencing and after completion of all sequences .
METHODS	Translational attraction and torque values of specimens were also evaluated .
METHODS	One-way ANOVA test was used to compare continuous variables of temperature change .
METHODS	Significance was set at p < 0.05 .
RESULTS	None of the groups exhibited excessive heating ( highest temperature change : < 3.04 C ) , with the maximum increase in temperature observed at the end of the T1 weighted axial sequence .
RESULTS	Magnetic field interactions changed depending on the material used .
RESULTS	Although the brackets presented minor interactions that would not cause movement in situ , nickel-titanium and stainless steel wires presented great interactions that may pose a risk for the patient .
CONCLUSIONS	The temperature changes of the specimens were considered to be within acceptable ranges .
CONCLUSIONS	With regard to magnetic field interactions , brackets can be considered `` MR safe '' ; however , it would be safe to replace the wires before MRI .

###24617228
OBJECTIVE	To observe differences of clinical therapeutic effects between deep-oblique acupuncture with long needle and regular perpendicular acupuncture at Guanyuan ( CV 4 ) for urinary retention to explore standard acupuncture method in clinic .
METHODS	One hundred and thirty-two cases of urinary retention were randomly divided into an observation group ( 78 cases ) and a control group ( 54 cases ) .
METHODS	Needles with 75 mm in length were deeply and obliquely inserted into Guanyuan ( CV 4 ) in the observation group while needles with 40 mm in length were perpendicularly inserted .
METHODS	Clinical therapeutic effects in two groups were observed .
RESULTS	After treatment the total effective rate was 80.8 % ( 63/78 ) in the observation group and 57.4 % ( 31/54 ) in the control group , which had significant difference between two groups ( P < 0.05 ) .
RESULTS	The curative effect of postpartum retention of urine was obviously superior to that of postoperative and prostate-induced urinary retention in the ebservation group , and the effect of urinary retention due to different etiology in the observation was also superior to that in the control group in the ebservation group [ in the observation group total effective rate was 88.6 % ( 47/53 ) in postpartum retention of urine , 50.0 % ( 3/6 ) in prostate-induced urinary retention and 68.4 % ( 13/19 ) in orthopedic postoperative retention of urine while in the control group total effective rate was 69.4 % ( 25/36 ) in postpartum retention of urine , 20.0 % ( 1/5 ) in prostate-induced urinary retention and 38.5 % ( 5/13 ) in orthopedic postoperative retention of urine ) ] .
CONCLUSIONS	The deep-oblique acupuncture with long needle at Guanyuan ( CV 4 ) has significant curative effect on urinary retention in clinic , especially for patients with postpartum urinary retention , which could be taken as standard acupuncture method .

###25872665
BACKGROUND	Knee osteoarthritis is a major cause of disability in the aging population .
BACKGROUND	Based on pathological , magnetic resonance imaging ( MRI ) and arthroscopy studies , progressive osteoarthritis involves all tissues of the joint and includes bone marrow lesions , synovial proliferation , fat pad inflammation , and high subchondral bone turnover .
BACKGROUND	Recent research suggests that abnormal perfusion in bone marrow lesions , fat pads , and subchondral bone is associated with pain in knee osteoarthritis , and that dynamic contrast-enhanced MRI is a promising method for studying micro-perfusion alteration in knee osteoarthritis .
BACKGROUND	Traditional Chinese Medicine approaches have been employed for thousands of years to relieve knee osteoarthritis pain .
BACKGROUND	Among herbal medicines , the Jingui external lotion is the preferred and most commonly used method in China to reduce pain in patients with knee osteoarthritis ; however , there is a lack of validated evidence for its effectiveness .
BACKGROUND	The purpose of this study is to explore the effectiveness of Jingui external lotion for the management of painful knee osteoarthritis in a short-term study .
BACKGROUND	In addition , we will assess micro-perfusion alteration in the patellar fat pad as well as the femur and tibia subchondral bone via dynamic contrast-enhanced MRI .
METHODS	This trial is a randomized , controlled study .
METHODS	A total of 168 patients will be randomized into the following two groups : 1 ) the Jingui external lotion group ( treatment group ) ; and 2 ) the placebo lotion group ( control group ) .
METHODS	In both groups , lotion fumigation and external washing of the patients ' knees will be administered twice a day for 14 consecutive days .
METHODS	Follow-up will be at regular intervals during a 4-week period with a visual analog scale to assess pain , and additional characterization with the Western Ontario and McMaster Universities Index score ; rescue medication will be recorded as the extent and time pattern .
METHODS	In addition , micro-perfusion alteration in the patellar fat pad , femur and tibia subchondral bone will be assessed via dynamic contrast-enhanced MRI .
CONCLUSIONS	This study will provide clinical evidence of the efficacy of Jingui external lotion in treating knee osteoarthritis , and it will be the first randomized controlled trial to investigate micro-perfusion alteration of knee osteoarthritis with Traditional Chinese Medicine external lotion via dynamic contrast-enhanced MRI .
BACKGROUND	ClinicalTrials.gov identifier : ChiCTR-TRC-14004727 ; 31 May 2014 .

###24850114
BACKGROUND	Reports of prevalence of spinal pain indicate the prevalence of thoracic pain in approximately 13 % of the general population compared to 32 % of the population with neck pain and 43 % of the population with low back pain during the past year .
BACKGROUND	Even though , thoracic pain is less common than neck or low back pain , the degree of disability resulting from thoracic pain disorders seems to be similar to other painful conditions .
BACKGROUND	Interventions in managing chronic thoracic pain are also less frequent , leading to the paucity of literature about various interventions in managing chronic thoracic pain .
BACKGROUND	Thoracic intervertebral discs and thoracic facet joints have been shown to be pain generators , even though thoracic radicular pain is very infrequent .
BACKGROUND	Thoracic epidural injections are one of the commonly performed procedures in managing thoracic pain .
BACKGROUND	The efficacy of thoracic epidural injections has not been well studied .
METHODS	A randomized , double-blind , active controlled trial .
METHODS	Private interventional pain management practice and specialty referral center in the United States .
OBJECTIVE	The primary objective was to assess the effectiveness of thoracic interlaminar epidural injections in providing effective pain relief and improving function in patients with chronic mid and/or upper back pain .
METHODS	One hundred and ten patients were randomly assigned into 2 groups with 55 patients in each group receiving either local anesthetic alone ( Group I ) or local anesthetic with steroids ( Group II ) .
METHODS	Randomization was performed by computer-generated random allocation sequence by simple randomization .
METHODS	Outcomes were assessed utilizing Numeric Rating Scale ( NRS ) , the Oswestry Disability Index ( ODI ) 2.0 , employment status , and opioid intake .
METHODS	The patients experiencing greater than 3 weeks of significant improvement with the first 2 procedures were considered as successful .
METHODS	Others were considered as failed participants .
METHODS	Significant improvement was defined as a decrease of greater than 50 % NRS scores and ODI scores with measurements performed at baseline , 3 , 6 , 12 , 18 , and 24 months post treatment .
RESULTS	Significant improvement was seen in 71 % in Group I and 80 % in Group II at the end of 2 years with all participants ; however , improvement was seen in 80 % and 86 % when only successful patients were considered .
RESULTS	Therapeutic procedural characteristics showed 5 to 6 procedures per 2 years with total average relief of 80 weeks in Group I and 78 weeks in Group II in the successful patient category ; whereas , it was 71 and 72 weeks when all patients were considered .
CONCLUSIONS	Limitations of this assessment include lack of a placebo group .
CONCLUSIONS	Based on the results of this trial , it is concluded that chronic thoracic pain of non-facet joint origin may be managed conservatively with thoracic interlaminar epidural injections with or without steroids .

###24297981
BACKGROUND	Falls are common in older people and are associated with substantial health-care costs .
BACKGROUND	A recent randomized controlled trial of a multifaceted podiatric medical intervention demonstrated a 36 % reduction in the fall rate over 12 months .
BACKGROUND	We evaluated the acceptability of and levels of satisfaction with this intervention in the older people who participated in the trial .
METHODS	Participants allocated to the intervention group ( which included a home-based program of foot and ankle exercises , assistance with the purchase of safe footwear when necessary , and provision of prefabricated foot orthoses ) completed a structured questionnaire 6 months after they had received the intervention .
METHODS	The questions addressed participants ' perceptions of their balance and foot and ankle strength , the perceived difficulty of the exercise program , and the degree of satisfaction with the footwear and orthoses provided .
RESULTS	Of 153 participants , 134 ( 87.6 % ) attended the 6-month follow-up assessment and completed the questionnaire .
RESULTS	Most participants perceived improvements in balance ( 62.7 % ) and foot and ankle strength ( 74.6 % ) after 6 months of performing the exercises , and 86.6 % considered the difficulty level of the exercises to be `` about right . ''
RESULTS	Most participants reported that they were somewhat or very satisfied with the footwear ( 92.3 % ) and orthoses ( 81.6 % ) provided .
CONCLUSIONS	The multifaceted podiatric medical intervention used in this trial was generally perceived to be beneficial and demonstrated high levels of satisfaction among participants .
CONCLUSIONS	Further research is now required to evaluate the feasibility of implementing the intervention in a range of clinical practice settings .

###24622164
OBJECTIVE	The effect of teaching crisis resource management skills on the resuscitation performance of pediatric residents is unknown .
OBJECTIVE	The primary objective of this pilot study was to determine if teaching crisis resource management to residents leads to improved clinical and crisis resource management performance in simulated pediatric resuscitation scenarios .
METHODS	A prospective , randomized control pilot study .
METHODS	Simulation facility at tertiary pediatric hospital .
METHODS	Junior pediatric residents .
METHODS	Junior pediatric residents were randomized to 1 hour of crisis resource management instruction or no additional training .
RESULTS	Time to predetermined resuscitation tasks was noted in simulated resuscitation scenarios immediately after intervention and again 3 months post intervention .
RESULTS	Crisis resource management skills were evaluated using the Ottawa Global Rating Scale .
RESULTS	Fifteen junior residents participated in the study , of which seven in the intervention group .
RESULTS	The intervention crisis resource management group placed monitor leads 24.6 seconds earlier ( p = 0.02 ) , placed an IV 47.1 seconds sooner ( p = 0.04 ) , called for help 50.4 seconds faster ( p = 0.03 ) , and checked for a pulse after noticing a rhythm change 84.9 seconds quicker ( p = 0.01 ) .
RESULTS	There was no statistically significant difference in time to initiation of cardiopulmonary resuscitation ( p = 0.264 ) .
RESULTS	The intervention group had overall crisis resource management performance scores 1.15 points higher ( Ottawa Global Rating Scale [ out of 7 ] ) ( p = 0.02 ) .
RESULTS	Three months later , these differences between the groups persisted .
CONCLUSIONS	A 1-hour crisis resource management teaching session improved time to critical initial steps of pediatric resuscitation and crisis resource management performance as measured by the Ottawa Global Rating Scale .
CONCLUSIONS	The control group did not develop these crisis resource management skills over 3 months of standard training indicating that obtaining these skills requires specific education .
CONCLUSIONS	Larger studies of crisis resource education are required .

###24583903
BACKGROUND	Cardiovascular disease and dementia are growing medical and social problems in aging societies .
BACKGROUND	Appropriate knowledge of cardiovascular disease and cognitive decline risk factors ( RFs ) are critical for global CVR health preventive intervention .
BACKGROUND	Many epidemiological studies use case definition based on data collected/measured in a single visit , a fact that can overestimate prevalence rates and distant from clinical practice demanding criteria .
BACKGROUND	Portugal displays an elevated stroke mortality rate .
BACKGROUND	However , population 's global CV risk characterization is limited , namely , considering traditional/nontraditional RF and new intermediate phenotypes of CV and renal disease .
BACKGROUND	Association of hemodynamic variables ( pulse wave velocity and central blood pressure ) with global CVR stratification , cognitive performance , and kidney disease are practically inexistent at a dwelling population level .
METHODS	After reviewing published data , we designed a population-based cohort study to analyze the prevalence of these cardiovascular RFs and intermediate phenotypes , using random sampling of adult dwellers living in 2 adjacent cities .
METHODS	Strict definition of phenotypes was planned : subjects were observed twice , and several hemodynamic and other biological variables measured at least 3 months apart .
RESULTS	Three thousand thirty-eight subjects were enrolled , and extensive data collection ( including central and peripheral blood pressure , pulse wave velocity ) , sample processing , and biobank edification were carried out .
RESULTS	One thousand forty-seven cognitive evaluations were performed .
CONCLUSIONS	Seeking for CV risk reclassification , early identification of subjects at risk , and evidence of early vascular aging and cognitive and renal function decline , using the strict daily clinical practice criteria , will lead to better resource allocation in preventive measures at a population level .

###24267363
BACKGROUND	Cow 's milk protein ( CMP ) - specific IgG4 responses and the efficacy of oral desensitization in infants with cow 's milk allergy ( CMA ) warrant more clarification .
OBJECTIVE	To explore whether CMP-specific IgG4 responses develop during infancy and whether regular CM exposure is efficacious for inducing a CMP-specific IgG4 response accompanying CM desensitization in 7 - to 12-month-old infants .
METHODS	CM-specific IgE and CMP ( - lactalbumin , - lactoglobulin , and casein ) - specific IgG4 levels were measured in 262 CM-sensitized children .
METHODS	Of these , 31 infants 7 to 12 months old with challenge-proved CMA were randomly assigned to oral desensitization or an elimination diet and evaluated 6 months later .
RESULTS	CMP-specific IgG4 levels in 7 - to 12-month-old infants were higher than in those younger than 6 months but comparable to those in children older than 12 months .
RESULTS	CMP-specific IgG4 levels in 7 - to 12-month-old infants with CMA were significantly lower than in those without CMA .
RESULTS	Fourteen of 16 patients receiving oral desensitization could accept daily doses of 200 mL of CM , whereas all but 3 dropout patients receiving the elimination diet still showed allergic symptoms at the follow-up food challenge .
RESULTS	In patients who became desensitized , CM-specific IgE levels were lower than at baseline , whereas CMP-specific IgG4 levels were significantly increased .
RESULTS	In patients receiving the elimination diet , CM-specific IgE and CMP-specific IgG4 levels remained unchanged .
CONCLUSIONS	CMP-specific IgG4 responses did not develop sufficiently in 7 - to 12-month-old infants with CMA .
CONCLUSIONS	Oral desensitization in 7 - to 12-month-old infants with CMA was associated with the upregulation of CMP-specific IgG4 responses accompanying the alleviation of CMA symptoms .

###25215556
BACKGROUND	Data are needed to guide therapeutic decisions about stopping bisphosphonates after an initial treatment period .
OBJECTIVE	To define significant predictors of fracture and quantify fracture incidence in risk factor-defined subgroups of women who discontinue zoledronic acid ( ZOL ) after 3 years of treatment .
OBJECTIVE	To determine if continuing ZOL reduces fracture risk in subgroups .
METHODS	This study is based on data from the 3 year extension of HORIZON .
METHODS	Subjects were in the ZOL arm of the Multicenter HORIZON trial .
METHODS	One thousand two hundred thirty three women who previously received 3 ZOL treatments during the Core trial .
METHODS	Randomization to three additional annual ZOL ( Z6 , n = 616 ) or placebo infusions ( Z3P3 , n = 617 ) .
RESULTS	The risk of morphometric vertebral fractures ( MorphVertFx ) and clinical nonvertebral fractures ( NVF ) .
RESULTS	The incidence of MorphVertFx in Z3P3 was predicted by femoral neck ( FN ) t-score -2.5 [ OR 3.3 ( 1.4 , 8.0 ) , p = .008 ] , total hip ( TH ) t-score -2.5 [ OR 4.0 ( 1.8 , 9.0 ) , p = .0007 ] , and incident MorphVertFx during Core [ OR 4.75 ( 1.4 , 16.8 ) , p < .015 ] .
RESULTS	Incidence of NVF was predicted by TH t-score [ for 1 decline , HR 1.7 ( 1.2 , 2.6 ) , p = .008 ] , incident NVF during Core [ HR 2.5 ( 1.2 , 5.3 ) , p = .014 ] , and prevalent vertebral fracture [ HR 3.0 ( 1.4 , 6.3 ) , p = .005 ] .
RESULTS	For MorphVertFx , there were no significant treatment subgroup interactions ; absolute fracture reductions with continued ZOL were greatest in high-risk subgroups .
RESULTS	For NVF , there were no significant treatment reductions overall or in subgroups and no significant interactions .
CONCLUSIONS	After 3 years of ZOL , in women who have a TH t-score above -2.5 , no recent incident fracture and no more than one risk factor ( almost 55 % of the population ) , risk for subsequent fracture ( over three additional years ) is low if treatment is discontinued ( for MorphVertFx , average risk 3.2 % and for NVF , average risk 5.8 % ) .
CONCLUSIONS	In these patients , discontinuation for up to 3 years is reasonable .

###24616136
BACKGROUND	Brief interventions delivered by family physicians to address excessive alcohol use among adult patients are effective .
BACKGROUND	We conducted a study to determine whether such an intervention would be similarly effective in reducing binge drinking and excessive cannabis use among young people .
METHODS	We conducted a cluster randomized controlled trial involving 33 family physicians in Switzerland .
METHODS	Physicians in the intervention group received training in delivering a brief intervention to young people during the consultation in addition to usual care .
METHODS	Physicians in the control group delivered usual care only .
METHODS	Consecutive patients aged 15-24 years were recruited from each practice and , before the consultation , completed a confidential questionnaire about their general health and substance use .
METHODS	Patients were followed up at 3 , 6 and 12 months after the consultation .
METHODS	The primary outcome measure was self-reported excessive substance use ( 1 episode of binge drinking , or 1 joint of cannabis per week , or both ) in the past 30 days .
RESULTS	Of the 33 participating physicians , 17 were randomly allocated to the intervention group and 16 to the control group .
RESULTS	Of the 594 participating patients , 279 ( 47.0 % ) identified themselves as binge drinkers or excessive cannabis users , or both , at baseline .
RESULTS	Excessive substance use did not differ significantly between patients whose physicians were in the intervention group and those whose physicians were in the control group at any of the follow-up points ( odds ratio [ OR ] and 95 % confidence interval [ CI ] at 3 months : 0.9 [ 0.6-1 .4 ] ; at 6 mo : 1.0 [ 0.6-1 .6 ] ; and at 12 mo : 1.1 [ 0.7-1 .8 ] ) .
RESULTS	The differences between groups were also nonsignificant after we restricted the analysis to patients who reported excessive substance use at baseline ( OR 1.6 , 95 % CI 0.9-2 .8 , at 3 mo ; OR 1.7 , 95 % CI 0.9-3 .2 , at 6 mo ; and OR 1.9 , 95 % CI 0.9-4 .0 , at 12 mo ) .
CONCLUSIONS	Training family physicians to use a brief intervention to address excessive substance use among young people was not effective in reducing binge drinking and excessive cannabis use in this patient population .
BACKGROUND	Australian New Zealand Clinical Trials Registry , no .
BACKGROUND	ACTRN12608000432314 .

###24666176
OBJECTIVE	To evaluate a new levonorgestrel-releasing intrauterine system ( LNG-IUS ) called Levosert ( ) for the treatment of heavy menstrual bleeding ( HMB ) in comparison to the reference product Mirena ( ) .
METHODS	A multicentre , randomised , controlled trial , in non-menopausal women diagnosed with functional HMB ( defined as menstrual blood loss [ MBL ] 80 mL ) randomised to either Levosert ( ) or Mirena ( ) and followed for up to one year .
METHODS	MBL was evaluated using a validated modified version of the Wyatt pictogram .
RESULTS	A total of 280 women were randomised ( 141 to Levosert ( ) and 139 to Mirena ( ) ) .
RESULTS	During the one-year treatment period , both Levosert ( ) and Mirena ( ) dramatically decreased MBL and increased haemoglobin and ferritin levels .
RESULTS	There were no statistically significant differences between Levosert ( ) and Mirena ( ) regarding any of the parameters evaluated during the study .
RESULTS	Similar bleeding patterns were observed in both groups .
RESULTS	Levosert ( ) was inserted with the same ease as Mirena ( ) .
RESULTS	Both treatments were associated with identical expulsion rates and no perforations occurred in either treatment group .
CONCLUSIONS	Levosert ( ) , a new LNG-IUS designed to release the same daily amount of LNG as Mirena ( ) , is highly effective in the treatment of HMB .
CONCLUSIONS	No differences were observed between Levosert ( ) and Mirena ( ) regarding all evaluated outcomes , including safety profile .

###25262636
OBJECTIVE	Cardiopulmonary bypass is still a major cause of lung injury and delay in pulmonary recovery after cardiac surgery .
OBJECTIVE	Although it has been shown that pulsatile flow induced by intra-aortic balloon pumping is beneficial for preserving lung function , it is not clear if the same beneficial effect can be accomplished with pulsatile flow generated in the extracorporeal circuit .
OBJECTIVE	Therefore , we investigated the effect of pulsatile flow , produced by a centrifugal pump , on lung function in elderly patients .
METHODS	Serial measurements of lung biomarkers Clara cell 16 kD protein , surfactant protein D , and elastase were performed on blood samples from 37 elderly patients ( 75 years ) who underwent elective aortic valve replacement surgery with CPB , either with pulsatile perfusion or continuous perfusion .
METHODS	Pulmonary function was assessed by postoperative ventilation time , the arterial blood oxygenation ( PaO2/FiO2 ) , the alveolar-arterial oxygen gradient ( Aa-O2 gradient ) and the pulmonary vascular resistance indexed by body surface area ( PVRi ) .
RESULTS	There was no difference in lung function between both groups , as assessed by the postoperative ventilation time , the PaO2/FiO2 ratio , and the Aa-O2 gradient .
RESULTS	The PVRi , however , was significantly lower in the pulsatile perfusion group 15 mins after the administration of protamine ( p < 0.05 ) .
RESULTS	The plasma concentrations of the lung biomarkers increased during surgery and peaked at 1 h ICU , there were however no differences between groups .
CONCLUSIONS	Pulsatile flow does not seem beneficial to postoperative lung function in elderly patients .
CONCLUSIONS	Moreover , pulsatile flow does not affect lung function on a subclinical level as assessed by lung biomarkers .

###24854723
OBJECTIVE	The objective of this study was to investigate functional abnormalities of the brain in females with migraine using magnetoencephalography ( MEG ) and a finger-tapping task .
METHODS	Twenty-nine female patients with migraine ( aged 16-40years ) and age - and gender-matched healthy controls were studied with an MEG system at a sampling rate of 6000Hz .
METHODS	MEG recordings were performed during an attack in migraineurs with and without aura .
METHODS	Neuromagnetic brain activation was elicited by a finger-tapping task .
METHODS	The latency and amplitude of neuromagnetic responses were analyzed with averaged waveforms in the frequency range of 5-100Hz .
METHODS	The Morlet wavelet and beamformers were used to analyze the spectral and spatial signatures of MEG data from subjects in two frequency ranges of 5-100 and 100-1000Hz .
RESULTS	The latency of motor-evoked magnetic fields evoked by finger movement was significantly prolonged in migraineurs as compared with controls .
RESULTS	Neuromagnetic spectral power in the motor cortex in migraineurs was significantly elevated .
RESULTS	There were significantly higher odds of activation in 5-30 , 100-300 and 500-700Hz frequency ranges in the ipsilateral primary motor cortices and the supplementary motor area in migraineurs as compared with controls .
CONCLUSIONS	Neuromagnetic signal abnormalities in this study suggest cortical hyperexcitability in females with migraine during migraine attack , which could be measured and analyzed with MEG signal in a frequency range of 5-1000Hz .
CONCLUSIONS	These findings may help to identify neurophysiological biomarkers for studying mechanisms of migraine , and may facilitate to develop new therapeutic strategies for migraine by alterations in cortical excitability .

###25384017
OBJECTIVE	Among older home health care patients , depression is highly prevalent , is often inadequately treated , and contributes to hospitalization and other poor outcomes .
OBJECTIVE	Feasible and effective interventions are needed to reduce this burden of depression .
OBJECTIVE	To determine whether , among older Medicare Home Health recipients who screen positive for depression , patients of nurses receiving randomization to an intervention have greater improvement in depressive symptoms during 1 year than patients receiving enhanced usual care .
METHODS	This cluster randomized effectiveness trial conducted at 6 home health care agencies nationwide assigned nurse teams to an intervention ( 12 teams ) or to enhanced usual care ( 9 teams ) .
METHODS	Between January 13 , 2009 , and December 6 , 2012 , Medicare Home Health patients 65 years and older who screened positive for depression on routine nursing assessments were recruited , underwent assessment , and were followed up at 3 , 6 , and 12 months by research staff blinded to intervention status .
METHODS	Patients were interviewed at home and by telephone .
METHODS	Of 502 eligible patients , 306 enrolled in the study .
METHODS	The Depression Care for Patients at Home ( Depression CAREPATH ) trial requires nurses to manage depression at routine home visits by weekly symptom assessment , medication management , care coordination , education , and goal setting .
METHODS	Nurses ' training totaled 7 hours ( 4 onsite and 3 via the web ) .
METHODS	Researchers telephoned intervention team supervisors every other week .
METHODS	Depression severity , assessed by the 24-item Hamilton Scale for Depression ( HAM-D ) .
RESULTS	The 306 participants were predominantly female ( 69.6 % ) , were racially/ethnically diverse ( 18.0 % black and 16.0 % Hispanic ) , and had a mean ( SD ) age of 76.5 ( 8.0 ) years .
RESULTS	In the full sample , the intervention had no effect ( P = .13 for intervention time interaction ) .
RESULTS	Adjusted HAM-D scores ( Depression CAREPATH vs control ) did not differ at 3 months ( 10.5 vs 11.4 , P = .26 ) or at 6 months ( 9.3 vs 10.5 , P = .12 ) but reached significance at 12 months ( 8.7 vs 10.6 , P = .05 ) .
RESULTS	In the subsample with mild depression ( HAM-D score , < 10 ) , the intervention had no effect ( P = .90 ) , and HAM-D scores did not differ at any follow-up points .
RESULTS	Among 208 participants with a HAM-D score of 10 or higher , the Depression CAREPATH demonstrated effectiveness ( P = .02 ) , with lower HAM-D scores at 3 months ( 14.1 vs 16.1 , P = .04 ) , at 6 months ( 12.0 vs 14.7 , P = .02 ) , and at 12 months ( 11.8 vs 15.7 , P = .005 ) .
CONCLUSIONS	Home health care nurses can effectively integrate depression care management into routine practice .
CONCLUSIONS	However , the clinical benefit seems to be limited to patients with moderate to severe depression .
BACKGROUND	clinicaltrials.gov Identifier : NCT01979302 .

###25844062
BACKGROUND	In preparing novice anesthesiologists to perform their first ultrasound-guided axillary brachial plexus blockade , we hypothesized that virtual reality simulation-based training offers an additional learning benefit over standard training .
BACKGROUND	We carried out pilot testing of this hypothesis using a prospective , single blind , randomized controlled trial .
METHODS	We planned to recruit 20 anesthesiologists who had no experience of performing ultrasound-guided regional anesthesia .
METHODS	Initial standardized training , reflecting current best available practice was provided to all participating trainees .
METHODS	Trainees were randomized into one of two groups ; ( i ) to undertake additional simulation-based training or ( ii ) no further training .
METHODS	On completion of their assigned training , trainees attempted their first ultrasound-guided axillary brachial plexus blockade .
METHODS	Two experts , blinded to the trainees ' group allocation , assessed the performance of trainees using validated tools .
RESULTS	This study was discontinued following a planned interim analysis , having recruited 10 trainees .
RESULTS	This occurred because it became clear that the functionality of the available simulator was insufficient to meet our training requirements .
RESULTS	There were no statistically significant difference in clinical performance , as assessed using the sum of a Global Rating Score and a checklist score , between simulation-based training [ mean 32.9 ( standard deviation 11.1 ) ] and control trainees [ 31.5 ( 4.2 ) ] ( p = 0.885 ) .
CONCLUSIONS	We have described a methodology for assessing the effectiveness of a simulator , during its development , by means of a randomized controlled trial .
CONCLUSIONS	We believe that the learning acquired will be useful if performing future trials on learning efficacy associated with simulation based training in procedural skills .
BACKGROUND	ClinicalTrials.gov identifier : NCT01965314 .
BACKGROUND	Registered October 17th 2013 .

###24555575
BACKGROUND	The aim of this study was to evaluate the clinical efficacy of submandibular gland transfer for the prevention of xerostomia after radiotherapy for nasopharyngeal carcinoma .
METHODS	Using the randomized controlled clinical research method , 65 patients with nasopharyngeal carcinoma were randomly divided into an experimental group consisting of 32 patients and a control group consisting of 33 patients .
METHODS	The submandibular glands were averted to the submental region in 32 patients with nasopharyngeal carcinoma before they received conventional radiotherapy ; a lead block was used to shield the submental region during therapy .
METHODS	Prior to radiotherapy , the function of the submandibular glands was assessed using imaging .
METHODS	Submandibular gland function was measured using 99mTc radionuclide scanning at 60 months after radiotherapy .
METHODS	The data in the questionnaire regarding the degree of xerostomia were investigated and saliva secretion was measured at 3 , 6 , 12 , and 60 months after radiotherapy .
METHODS	In addition , the 5-year survival rate was calculated .
RESULTS	After follow-up for 3 , 6 , and 12 months , the incidence of moderate to severe xerostomia was significantly lower in the experimental group than in the control group .
RESULTS	The average amount of saliva produced by the experimental and control groups was 1.60 g and 0.68 g , respectively ( P < 0.001 ) .
RESULTS	After follow-up for 60 months , the uptake and secretion functions of the submandibular glands in the experimental group were found to be significantly higher than in the control group ( P < 0.001 and P < 0.001 , respectively ) .
RESULTS	The incidence of moderate or severe xerostomia was significantly lower than in the control group ( 15.4 % and 76.9 % , respectively ; P < 0.001 ) .
RESULTS	The 5-year survival rates of the experimental group and the control group were 81.3 % and 78.8 % , respectively , and there was no significant difference between the two groups ( P = 0.806 ) .
CONCLUSIONS	After a 5 year follow-up period involving 32 patients who had their submandibular glands transferred for the prevention of xerostomia after radiotherapy for nasopharyngeal carcinoma , we found that clinical efficacy was good .
CONCLUSIONS	This approach could improve the quality of life of nasopharyngeal carcinoma patients after radiotherapy and would not affect long-term treatment efficacy .

###25457732
OBJECTIVE	To provide a framework for implementation of multicomponent , school-based nutrition interventions .
OBJECTIVE	This article describes the research methods for the Shaping Healthy Choices Program , a model to improve nutrition and health-related knowledge and behaviors among school-aged children .
METHODS	Longitudinal , pretest/posttest , randomized , controlled intervention .
METHODS	Four elementary schools in California .
METHODS	Fourth-grade students at intervention ( n = 252 ) and control ( n = 238 ) schools and their parents and teachers .
METHODS	Power analyses demonstrate that a minimum of 159 students per group will be needed to achieve sufficient power .
METHODS	The sample size was determined using the variables of nutrition knowledge , vegetable preference score , and body mass index percentile .
METHODS	A multicomponent school-based nutrition education intervention over 1 academic year , followed by activities to support sustainability of the program .
METHODS	Dietary and nutrition knowledge and behavior , critical thinking skills , healthy food preferences and consumption , and physical activity will be measured using a nutrition knowledge questionnaire , a food frequency questionnaire , a vegetable preferences assessment tool , the Test of Basic Science Process Skills , digital photography of plate waste , PolarActive accelerometers , anthropometrics , a parent questionnaire , and the School and Community Actions for Nutrition survey .
METHODS	Evaluation will include quantitative and qualitative measures .
METHODS	Quantitative data will use paired t , chi-square , and Mann-Whitney U tests and regression modeling using P = .05 to determine statistical significance .

###24825515
BACKGROUND	The performance of glomerular filtration rate ( GFR ) equations incorporating both cystatin C ( CysC ) and serum creatinine ( Creat ) in living kidney donors has not been studied before .
METHODS	From a population of 3,698 living kidney donors , 257 donors were randomly selected to undergo GFR measurement ( mGFR ) by the plasma disappearance of iohexol .
METHODS	GFR was estimated with the Modification of Diet in Renal Disease ( MDRD ) equation and the Chronic Kidney Disease Epidemiology Collaboration study eGFR ( CKD-EPI-Creat ) in 257 donors and the two newly developed equations using CysC with and without Creat , eGFR ( CKD-EPI-CysC ) and eGFR ( CKD-EPI-Creat + CysC ) , in 215 donors .
RESULTS	Mean mGFR was 71.811.8 mL/min/1 .73 m.
RESULTS	The eGFR ( MDRD ) exhibited least and only negative bias and the three other models were comparable in terms of bias .
RESULTS	The eGFR ( CKD-EPI-Creat + CysC ) equation was most precise ; r = 0.64 .
RESULTS	Both eGFR ( MDRD ) and eGFR ( CKD-EPI-Creat + CysC ) had high percentage ( 94.4 % and 92.6 % , respectively ) of estimates falling within 30 % of mGFR versus estimates by eGFR ( CKD-EPI-Creat ) and eGFR ( CKD-EPI-CysC ) equations ( 87.2 % and 85.1 % , respectively ) .
RESULTS	The eGFR ( MDRD ) was by far most accurate in identifying those with mGFR less than 60 mL/min/1 .73 m whereas the CKD-EPI models were extremely accurate in classifying those with mGFR greater than or equal to 60 mL/min/1 .73 m.
CONCLUSIONS	eGFR ( CKD-EPI-Creat + CysC ) equation provides comparable accuracy to the eGFR ( MDRD ) in overall estimation of mGFR , but with higher precision .
CONCLUSIONS	However , eGFR ( CKD-EPI-Creat + CysC ) clearly misses many of those with a post-donation GFR less than 60 mL/min/1 .73 m and therefore eGFR ( MDRD ) is preferable in detecting donors with GFR less than 60 mL/min/1 .73 m.

###25703478
OBJECTIVE	To compare the clinical efficacy of navigated pattern and conventional slit-lamp pattern panretinal photocoagulation ( PRP ) .
METHODS	Randomized clinical trial .
METHODS	Seventy-four eyes with proliferative diabetic retinopathy ( PDR ) in need of PRP were randomly assigned to 1 of 4 groups : PRP conventional pattern 30 ms , 100 ms , navigated pattern 30 ms , 100 ms pulse .
METHODS	Navigated laser is a fundus camera-based photocoagulator with retinal eye tracking .
METHODS	Outcome variables included stability of visual acuity , regression or development of neovascularization and need for retreatment sessions and surgical intervention , pain perception , and procedure time .
RESULTS	There was no change in visual acuity between pre - and post-treatment measurements among the study groups .
RESULTS	Short pulse groups in total required 22 procedures compared to 12 procedures in long pulse groups ( P < .05 ) .
RESULTS	A trend toward worse outcome using 30 ms pulse duration treatments is expressed by slightly increased relative risk of 1.3 compared to 100 ms groups .
RESULTS	Only 2 eyes required vitreoretinal surgery for nonclearing vitreous hemorrhage , 1 in each 30 ms group ; insignificantly different between study groups ( P = .98 ) .
RESULTS	The pain score was lower with navigated laser as compared to conventional laser in both 30 ms groups ( P = .1 ) and 100 ms groups , where it reached statistical significance ( P = .02 ) .
RESULTS	Pain experience was significant ( P < .001 ) between navigated 100 ms pattern and conventional single-spot 100 ms treatments .
CONCLUSIONS	This study demonstrates better clinical efficacy of 100 ms compared to 30 ms treatments using both conventional and navigated pattern lasers .
CONCLUSIONS	The ability to use long-pulse-duration navigated pattern treatments broadens therapeutic options for PRP in proliferative diabetic retinopathy .

###25153504
BACKGROUND	The response of Crohn 's disease ( CD ) stricture to endoscopic therapy compared with non-CD stricture is unknown .
BACKGROUND	Our aim was to compare the short - and long-term outcomes of endoscopic management of those strictures .
METHODS	All eligible patients with benign non-CD strictures who underwent the endoscopic balloon dilation between January 2002 and September 2013 were included .
METHODS	Patients with CD strictures were randomly selected with a ratio ( CD versus non-CD strictures ) of 2:1 .
RESULTS	A total of 90 patients were included , including 30 ( 33.3 % ) with non-CD strictures and 60 ( 66.7 % ) with CD strictures .
RESULTS	Patients with CD strictures were younger than those with non-CD strictures at the time of disease diagnosis ( 25.8 11.1 versus 50.5 17.5 ; P < 0.001 ) and at the time of the first dilation ( 43.9 12.4 versus 55.8 13.9 ; P < 0.001 ) .
RESULTS	There were no significant differences in characteristics of strictures and their endoscopic treatments between the CD and non-CD groups , except for the percentage of patients who were ever treated with intralesional corticosteroid injection ( 25.0 % versus 6.7 % , P = 0.046 ) .
RESULTS	Patients in the 2 groups had similar technical success rates ( 94.0 % versus 93.9 % , P = 1.00 ) .
RESULTS	Few patients in CD stricture group required emergency room visits due to obstructive symptoms from recurrence of disease ( 1.7 % versus 16.7 % , P = 0.02 ) .
RESULTS	There were on procedure-related complications in either of the 2 groups .
CONCLUSIONS	The efficacy and safety of endoscopic balloon dilation in the treatment of CD and non-CD strictures seemed to be comparable .

###24253140
OBJECTIVE	We compared the effects of intravenous administration of 6 % hydroxyethyl starch ( maize-derived ) in 0.9 % saline ( Voluven ; Fresenius Kabi , Runcorn , United Kingdom ) and a `` balanced '' preparation of 6 % hydroxyethyl starch ( potato-derived ) [ Plasma Volume Redibag ( PVR ) ; Baxter Healthcare , Thetford , United Kingdom ] on renal blood flow velocity and renal cortical tissue perfusion in humans using magnetic resonance imaging .
BACKGROUND	Hyperchloremia resulting from 0.9 % saline infusion may adversely affect renal hemodynamics when compared with balanced crystalloids .
BACKGROUND	This phenomenon has not been studied with colloids .
METHODS	Twelve healthy adult male subjects received 1-L intravenous infusions of Voluven or PVR over 30 minutes in a randomized , double-blind manner , with crossover studies 7 to 10 days later .
METHODS	Magnetic resonance imaging proceeded for 60 minutes after commencement of infusion to measure renal artery blood flow velocity and renal cortical perfusion .
METHODS	Blood was sampled , and weight was recorded at 0 , 30 , 60 , 120 , 180 , and 240 minutes .
RESULTS	Mean peak serum chloride concentrations were 108 and 106 mmol/L , respectively , after Voluven and PVR infusion ( P = 0.032 ) .
RESULTS	Changes in blood volume ( P = 0.867 ) , strong ion difference ( P = 0.219 ) , and mean renal artery flow velocity ( P = 0.319 ) were similar .
RESULTS	However , there was a significant increase in mean renal cortical tissue perfusion after PVR when compared with Voluven ( P = 0.033 ) .
RESULTS	There was no difference in urinary neutrophil gelatinase-associated liopcalin to creatinine ratios after the infusion ( P = 0.164 ) .
CONCLUSIONS	There was no difference in the blood volume-expanding properties of the 2 preparations of 6 % hydroxyethyl starch .
CONCLUSIONS	The balanced starch produced an increase in renal cortical tissue perfusion , a phenomenon not seen with starch in 0.9 % saline .

###25927321
BACKGROUND	The specific attributes of inhaler devices can influence patient use , satisfaction and treatment compliance , and may ultimately impact on clinical outcomes in patients with chronic obstructive pulmonary disease ( COPD ) .
OBJECTIVE	To assess patient preference , satisfaction and critical inhaler technique errors with Genuair ( a multidose inhaler ) and Breezhaler ( a single-dose inhaler ) after 2 weeks of daily use .
METHODS	Patients with COPD and moderate to severe airflow obstruction were randomised in a cross-over , open-label , multicentre study to consecutive once-daily inhalations of placebo via Genuair and Breezhaler , in addition to current COPD medication .
METHODS	The primary end point was the proportion of patients who preferred Genuair versus Breezhaler after 2 weeks ( Patient Satisfaction and Preference Questionnaire ) .
METHODS	Other end points included overall satisfaction and correct use of the inhalers after 2 weeks , and willingness to continue with each device .
RESULTS	Of the 128 patients enrolled , 127 were included in the safety population ( male n = 91 ; mean age 67.6 years ) .
RESULTS	Of the 110 of the 123 patients in the intent-to-treat population who indicated an inhaler preference , statistically significantly more patients preferred Genuair than Breezhaler ( 72.7 vs. 27.3 % ; P < 0.001 ) .
RESULTS	Mean overall satisfaction scores were also greater for Genuair than for Breezhaler ( 5.9 vs. 5.3 , respectively ; P < 0.001 ) .
RESULTS	After 2 weeks , there was no statistically significant difference in the number of patients who made 1 critical inhaler technique error with Breezhaler than with Genuair ( 7.3 vs. 3.3 % , respectively ) .
CONCLUSIONS	Patient overall preference and satisfaction was significantly higher with Genuair compared with Breezhaler .
CONCLUSIONS	The proportion of patients making critical inhaler technique errors was low with Genuair and Breezhaler .

###24858423
BACKGROUND	Prior studies of catheter-based renal artery denervation have not systematically performed ambulatory blood pressure monitoring ( ABPM ) to assess the efficacy of the procedure .
OBJECTIVE	SYMPLICITY HTN-3 ( Renal Denervation in Patients With Uncontrolled Hypertension ) was a prospective , blinded , randomized , sham-controlled trial .
OBJECTIVE	The current analysis details the effect of renal denervation or a sham procedure on ABPM measurements 6 months post-randomization .
METHODS	Patients with resistant hypertension were randomized 2:1 to renal denervation or sham control .
METHODS	Patients were on a stable antihypertensive regimen including maximally tolerated doses of at least 3 drugs including a diuretic before randomization .
METHODS	The powered secondary efficacy endpoint was a change in mean 24-h ambulatory systolic blood pressure ( SBP ) .
METHODS	Nondipper to dipper ( nighttime blood pressure [ BP ] 10 % to 20 % lower than daytime BP ) conversion was calculated at 6 months .
RESULTS	The 24-h ambulatory SBP changed-6 .8 15.1 mm Hg in the denervation group and-4 .8 17.3 mm Hg in the sham group : difference of-2 .0 mm Hg ( 95 % confidence interval [ CI ] : -5.0 to 1.1 ; p = 0.98 with a 2 mm Hg superiority margin ) .
RESULTS	The daytime ambulatory SBP change difference between groups was-1 .1 ( 95 % CI : -4.3 to 2.2 ; p = 0.52 ) .
RESULTS	The nocturnal ambulatory SBP change difference between groups was-3 .3 ( 95 CI : -6.7 to 0.1 ; p = 0.06 ) .
RESULTS	Thepercent of nondippers converted to dippers was 21.2 % in the denervation group and 15.0 % in the sham group ( 95 % CI : -3.8 % to 16.2 % ; p = 0.30 ) .
RESULTS	Change in 24-h heart rate was-1 .4 7.4 in the denervation group and-1 .3 7.3 in the sham group ; ( 95 % CI : -1.5 to 1.4 ; p = 0.94 ) .
CONCLUSIONS	This trial did not demonstrate a benefit of renal artery denervation on reduction in ambulatory BP ineither the 24-h or day and night periods compared with sham ( Renal Denervation in Patients WithUncontrolled Hypertension [ SYMPLICITY HTN-3 ] ; NCT01418261 ) .

###24762768
BACKGROUND	Chemotherapy-induced stomatitis is a major side effect of the treatment .
BACKGROUND	Numerous approaches are described in the literature for the prevention and treatment of this complication .
OBJECTIVE	the aim was assess the effectiveness of Gelclair in patients undergoing hematopoietic stem-cell transplantation in terms of reducing the incidence of stomatitis , stomatitis-pain and the severity of stomatitis
METHODS	Fifty-seven patients ( 28 control group and 29 experimental group ) used a mouthwash 3 times a day and were evaluated by means of a specially-tailored form containing the following assessment items : stomatitis evaluation scale ( WHO ) , VAS for pain and Likert-Scale for agreement .
RESULTS	61 % of patients presented with stomatitis .
RESULTS	No difference was observed between the two groups with regard to stomatitis grade throughout the observation period .
RESULTS	Painful symptoms were observed in 54 % subjects .
RESULTS	No differences were observed in terms of average pain perception before the use of mouthwashes throughout the period of observation p = 0.06 .
RESULTS	RESULTS showed a pain-relieving effect in the experimental group after using the mouthwash p = 0.04 .
CONCLUSIONS	Although Gelclair had no influence on the onset and severity of stomatitis in transplanted patients , a significant benefit was observed in terms of pain control .
CONCLUSIONS	Our study suggest the possibility to implementation the use of Gelclair in clinical practice .
CONCLUSIONS	However , further multicenter trials are needed to provide stronger evidence on the real usefulness of this product .

###24581773
OBJECTIVE	To compare laser in situ keratomileusis ( LASIK ) outcomes between 2 wavefront-guided excimer laser systems in the treatment of myopia .
METHODS	University eye clinic , Palo Alto , California , USA .
METHODS	Prospective comparative case series .
METHODS	One eye of patients was treated with the Allegretto Wave Eye-Q system ( small-spot scanning laser ) and the fellow eye with the Visx Star Customvue S4 IR system ( variable-spot scanning laser ) .
METHODS	Evaluations included measurement of uncorrected visual acuity , corrected visual acuity , and wavefront aberrometry .
RESULTS	One hundred eyes ( 50 patients ) were treated .
RESULTS	The mean preoperative spherical equivalent ( SE ) refraction was -3.89 diopters ( D ) 1.67 ( SD ) and -4.18 1.73 D in the small-spot scanning laser group and variable-spot scanning laser group , respectively .
RESULTS	There were no significant differences in preoperative higher-order aberrations ( HOAs ) between the groups .
RESULTS	Twelve months postoperatively , all eyes in the small-spot scanning laser group and 92 % in the variable-spot scanning laser group were within 0.50 D of the intended correction ( P = .04 ) .
RESULTS	At that time , the small-spot scanning laser group had significantly less spherical aberration ( 0.12 versus 0.15 ) ( P = .04 ) and significantly less mean total higher-order root mean square ( 0.33 m versus 0.40 m ) ( P = .01 ) .
RESULTS	Subjectively , patients reported that the clarity of night and day vision was significantly better in the eye treated with the small-spot scanning laser .
CONCLUSIONS	The predictability and self-reported clarity of vision of wavefront-guided LASIK were better with the small-spot scanning laser .
CONCLUSIONS	Eyes treated with the small-spot scanning laser had significantly fewer HOAs .

###24888732
BACKGROUND	This paper details the research protocol for a study funded by the Australian Research Council .
BACKGROUND	An integrated approach towards helping young children respond to the significant pressures of ' 360 degree marketing ' on their food choices , levels of active play , and sustainability consciousness via the early childhood curriculum is lacking .
BACKGROUND	The overall goal of this study is to evaluate the efficacy of curriculum interventions that educators design when using a pedagogical communication strategy on children 's knowledge about healthy eating , active play and the sustainability consequences of their toy food and toy selections .
METHODS	This cluster-randomised trial will be conducted with 300 , 4 to 5 year-old children attending pre-school .
METHODS	Early childhood educators will develop a curriculum intervention using a pedagogical communication strategy that integrates content knowledge about healthy eating , active play and sustainability consciousness and deliver this to their pre-school class .
METHODS	Children will be interviewed about their knowledge of healthy eating , active play and the sustainability consequences of their food and toy selections .
METHODS	Parents will complete an Eating and Physical Activity Questionnaire rating their children 's food preferences , digital media viewing and physical activity habits .
METHODS	All measures will be administered at baseline , the end of the intervention and 6 months post intervention .
METHODS	Informed consent will be obtained from all parents and the pre-school classes will be allocated randomly to the intervention or wait-list control group .
CONCLUSIONS	This study is the first to utilise an integrated pedagogical communication strategy developed specifically for early childhood educators focusing on children 's healthy eating , active play , and sustainability consciousness .
CONCLUSIONS	The significance of the early childhood period , for young children 's learning about healthy eating , active play and sustainability , is now unquestioned .
CONCLUSIONS	The specific teaching and learning practices used by early childhood educators , as part of the intervention program , will incorporate a sociocultural perspective on learning ; this perspective emphasises building on the play interests of children , that are experienced within the family and home context , as a basis for curriculum provision .
BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12614000363684 : Date registered : 07/04/2014 .

###24645337
BACKGROUND	Routine symptom and health-related quality of life ( HRQOL ) assessments can engage patients , give provider feedback , and improve doctor/patient communication .
OBJECTIVE	We compared the impact of a technology-assisted symptom monitoring system versus usual care on HRQOL and doctor/patient communication in early-stage prostate cancer ( PCa ) survivors .
METHODS	Men ( N = 94 ) were on average 62-years old , mostly African American ( AA ; 61.7 % ) , and 10-19 months post-treatment .
METHODS	They were randomized to symptom monitoring plus feedback ( SM + F ; n = 49 ) or usual care ( UC ; n = 45 ) .
METHODS	SM+F participants completed a 12-item telephoneassisted monitoring intervention .
METHODS	All participants completed a baseline and 2 follow-up interviews .
RESULTS	Among the SM+F participants , perceptions of the monitoring system were positive : 97.1 % endorsed it as easy/very easy to use and 85 % felt all patients could benefit from it .
RESULTS	At baseline , men reported favorable general and cancer-specific HRQOL and doctor/patient communication , but poorer urinary and sexual function .
RESULTS	Although there was no overall impact of the intervention , post hoc exploratory analyses indicated that among AA men , those who received SM+F improved relative to UC on doctor/patient communication ( P < .05 ) , general HRQOL ( P < .06 ) , and sexual function ( P < .05 ) .
CONCLUSIONS	Variability in survivor follow-up care , limited access to eligible participants , and minimal physician training in the use of reports likely decreased physician investment .
CONCLUSIONS	Overall , PCa survivors were receptive to this monitoring system .
CONCLUSIONS	Exploratory analyses suggest that this technology-assisted monitoring system may be of particular benefit to African American men .
CONCLUSIONS	Additional studies with larger samples , more intervention time-points , and increased physician training are needed to strengthen the intervention 's impact .

###24306695
BACKGROUND	Recombinant human bone morphogenetic protein-2 ( rhBMP-2 ) applied on an absorbable collagen sponge improves open tibial fracture-healing as an adjunct to unreamed intramedullary nail fixation .
BACKGROUND	We evaluated rhBMP-2 and a new , injectable calcium phosphate matrix ( CPM ) formulation in acute closed tibial diaphyseal fractures treated with reamed intramedullary nail fixation .
METHODS	Patients were randomized ( 1:2:2:1 ) to receive standard of care , which consisted of definitive fracture fixation within seventy-two hours of injury with a locked intramedullary nail after reaming ; standard of care and injection with 1.0 mg/mL of rhBMP-2 / CPM ; standard of care and injection with 2.0 mg/mL of rhBMP-2 / CPM ; or standard of care and injection with buffer/CPM , to evaluate the activity of the CPM delivery matrix and provide for sponsor and investigator blinding .
METHODS	The co-primary end points of the study were the effects of rhBMP-2 / CPM on the time to fracture union ( based on blinded assessment of radiographs ) and the time to return to normal function ( based on blinded assessment of the time to full weight-bearing without pain at the fracture site ) compared with standard of care alone .
RESULTS	Three hundred and sixty-nine patients were randomized and included in the intent-to-treat population .
RESULTS	This study was terminated after an interim analysis ( 180 patients with six months of follow-up ) revealed no shortening in the time to fracture union in the active treatment arms compared with the standard of care control ( the SOC group ) .
RESULTS	In the final primary analysis , the median time to radiographic fracture union was not significantly different for the SOC ( 13.1 weeks ) , 1.0-mg / mL rhBMP-2 / CPM ( 13.0 weeks ) , 2.0-mg / mL rhBMP-2 / CPM ( 15.9 weeks ) , or buffer/CPM ( 15.4 weeks ) treatment groups .
RESULTS	The median time to pain-free full weight-bearing was also not significantly different among the SOC ( 13.4 weeks ) , 1.0-mg / mL rhBMP-2 / CPM ( 13.4 weeks ) , 2.0-mg / mL rhBMP-2 / CPM ( 14.3 weeks ) , and buffer/CPM ( 16.4 weeks ) treatment groups .
CONCLUSIONS	In patients with closed tibial fractures treated with reamed intramedullary nailing , the time to fracture union and pain-free full weight-bearing were not significantly reduced by rhBMP-2 / CPM compared with standard of care alone .
CONCLUSIONS	24306696

###24468997
OBJECTIVE	African health services have shortages of clinical staff .
OBJECTIVE	We showed previously , in a cluster-randomized trial , that a home-based strategy using trained lay-workers is as effective as a clinic-based strategy .
OBJECTIVE	It is not known whether home-based care is suitable for patients with advanced HIV disease .
METHODS	The trial was conducted in Jinja , Uganda .
METHODS	One thousand , four hundred and fifty-three adults initiating ART between February 2005 and January 2009 were randomized to receive either home-based care or routine clinic-based care , and followed up for about 3 years .
METHODS	Trained lay workers , supervised by clinical staff based in a clinic , delivered the home-based care .
METHODS	In this sub-analysis , we compared survival between the two strategies for those who presented with CD4 cell count less than 50 cells/l and those who presented with higher CD4 cell counts .
METHODS	We used Kaplan-Meier methods and Poisson regression .
RESULTS	Four hundred and forty four of 1453 ( 31 % ) participants had baseline CD4 cell count less than 50cells/l .
RESULTS	Overall , 110 ( 25 % ) deaths occurred among participants with baseline CD4 cell count less than 50 cells/l and 87 ( 9 % ) in those with higher CD4 cell count .
RESULTS	Among participants with CD4 cell count less than 50 cells/l , mortality rates were similar for the home and facility-based arms ; adjusted mortality rate ratio 0.80 [ 95 % confidence interval ( CI ) 0.53-1 .18 ] compared with 1.22 ( 95 % CI 0.78-1 .89 ) for those who presented with higher CD4 cell count .
CONCLUSIONS	HIV home-based care , with lay workers playing a major role in the delivery of care including providing monthly adherence support , leads to similar survival rates as clinic-based care even among patients who present with very low CD4 cell count .
CONCLUSIONS	This emphasises the critical role of adherence to antiretroviral therapy .

###24977310
OBJECTIVE	Approximately 5.6 million South Africans are living with human immunodeficiency virus ( HIV ; UNAIDS , 2010 ) .
OBJECTIVE	Prevalence among Black adolescents and young adults is particularly alarming .
OBJECTIVE	This pilot study of an HIV preventive intervention targeting South African youth contributes to the growing body of research on culturally competent family-based interventions .
METHODS	A total of 99 parent-child dyads were enrolled in an experimental repeated measures study , using a wait-list control group .
METHODS	Our 6-session intervention targeted general parenting ( relationship quality , parental monitoring , and involvement ) , gender roles , and parent-youth communication about sex ( content and quality ) .
METHODS	Parents and youth were assessed at baseline , postintervention , and 6-month follow-up .
METHODS	Eligibility included being the primary female caregiver of a 10 - to 14-year-old child with whom they spent at least 4 nights a week and being able to participate in English or Xhosa .
RESULTS	Effect sizes with this small sample met or exceeded those of other family-based HIV interventions for youth in the United States and South Africa ( e.g. , Bell et al. , 2008 ; Forehand et al. , 2007 ) .
RESULTS	Parents ' reports at postintervention indicated larger effect sizes for general parenting than youths ' reports indicated .
RESULTS	Parents ' reports showed medium to large effects for all sex communication outcomes at postintervention and the 6-month follow-up .
RESULTS	Youth reports demonstrated small to medium effects for most communication variables and these effects lasted through the 6-month follow-up period .
CONCLUSIONS	Intergenerational social networks ( e.g. , families ) hold promise for HIV prevention among South African youth .
CONCLUSIONS	A full efficacy trial with longer-term follow-up and attention to maintenance of effects is warranted .

###25442425
OBJECTIVE	2-Ethyl-3-methylbutyl-carbamate ( EMC ) and 2-isopropylpentyl-carbamate ( IPC ) are among the most potent anticonvulsant carbamate derivatives of valproic acid .
OBJECTIVE	EMC and IPC are chiral compounds .
OBJECTIVE	Consequently , the aim of the current study was to comparatively evaluate the pharmacokinetic ( PK ) and pharmacodynamic ( PD anticonvulsant activity ) profile of EMC and IPC individual enantiomers .
METHODS	The anticonvulsant activity of EMC and IPC individual enantiomers was evaluated in several anticonvulsant rodent models including maximal electroshock ( MES ) , 6 Hz psychomotor , subcutaneous ( pentylenetetrazole ) ( scMet ) , and the pilocarpine-induced and soman-induced status epilepticus ( SE ) .
METHODS	The PK-PD relationship of EMC and IPC individual enantiomers was evaluated following intraperitoneal administration ( 50 mg/kg ) to rats .
METHODS	Induction of neural tube defects ( NTDs ) was evaluated in a mouse strain that was highly susceptible to teratogen-induced NTDs .
RESULTS	In mice and rats , ( 2S ) - EMC exhibited anticonvulsant activity similar to that of racemic EMC in the MES and scMet tests , whereas in the 6 Hz test , racemic EMC was more potent than its two individual enantiomers .
RESULTS	Racemic EMC exhibited a potent activity in the soman-induced SE model when administered 5 and 20 min after seizure onset with median effective dose ( ED50 ) values of 33 and 48 mg/kg , respectively .
RESULTS	( 2R ) - IPC and ( 2S ) - IPC exhibited ED50 values similar to those of racemic IPC in the mouse and rat MES and scMet models .
RESULTS	( 2R ) - IPC had similar ED50 values on the 6 Hz tests .
RESULTS	Racemic IPC had an ED50 value of 107 mg/kg in the pilocarpine-induced SE model when given 30 min after seizure onset .
RESULTS	Racemic EMC and IPC and their enantiomers had similar clearance ( 3.8-5 .5 L/h/kg ) and short half-life ( < 1 h ) .
RESULTS	EMC and its enantiomers did not cause NTDs at doses 3-10 times higher than their anticonvulsant ED50 values .
CONCLUSIONS	EMC and IPC did not exhibit enantioselective PK , a fact that may contribute to their nonenantioselective activity in any of the anticonvulsant models .
CONCLUSIONS	The nonsignificant difference between racemic EMC and racemic IPC and their enantiomers , suggests that their wide spectrum of anticonvulsant activity is likely to be caused by multiple mechanisms of action .

###24410433
BACKGROUND	Staged clinical treatment of pediatric obesity is recommended , but untested .
BACKGROUND	Understanding the lowest intensity stage 's effectiveness is necessary for future research .
METHODS	This was a randomized controlled trial of children ages 4 to < 9 years .
METHODS	Participants were recruited after routine evaluations at a primary care pediatric clinic revealed a BMI 85th percentile .
METHODS	The intervention was patterned after the `` Prevention plus , Stage 1 '' treatment recommended by an expert committee .
METHODS	Groups were compared for changes , over a 3-month time period , in BMI z-score and parental reports of behavioral issues related to childhood obesity using intent-to-treat ( ITT ) analysis .
RESULTS	Seventy-two ( 30 % of eligible ) children were enrolled and 64 were remeasured at 3-month follow-up .
RESULTS	ITT analysis revealed that both groups improved mean BMI z-score [ adjusted change -0.07 , control , and -0.04 , intervention ; 95 % confidence interval ( CI ) of difference = -0.14 -0.20 ] .
RESULTS	Over half of the children in each group improved their BMI z-score ( adjusted proportion decreasing = 55 % in control vs. 72 % in intervention ; 95 % CI of difference = -0.07 -0.42 ) .
RESULTS	The intervention group improved comparatively to the control group on numerous behavioral indicators .
CONCLUSIONS	Implementation of the lowest intensity stage of current recommendations is feasible and possibly of benefit toward lifestyle changes .
CONCLUSIONS	Results of this study can be used by future clinical researchers designing protocols to test the full multi-staged approach for the treatment of pediatric overweight and obesity in primary care clinical settings .

###25890673
BACKGROUND	Tenofovir disoproxil fumarate can cause renal and bone toxic effects related to high plasma tenofovir concentrations .
BACKGROUND	Tenofovir alafenamide is a novel tenofovir prodrug with a 90 % reduction in plasma tenofovir concentrations .
BACKGROUND	Tenofovir alafenamide-containing regimens can have improved renal and bone safety compared with tenofovir disoproxil fumarate-containing regimens .
METHODS	In these two controlled , double-blind phase 3 studies , we recruited treatment-naive HIV-infected patients with an estimated creatinine clearance of 50 mL per min or higher from 178 outpatient centres in 16 countries .
METHODS	Patients were randomly assigned ( 1:1 ) to receive once-daily oral tablets containing 150 mg elvitegravir , 150 mg cobicistat , 200 mg emtricitabine , and 10 mg tenofovir alafenamide ( E/C/F / tenofovir alafenamide ) or 300 mg tenofovir disoproxil fumarate ( E/C/F / tenofovir disoproxil fumarate ) with matching placebo .
METHODS	Randomisation was done by a computer-generated allocation sequence ( block size 4 ) and was stratified by HIV-1 RNA , CD4 count , and region ( USA or ex-USA ) .
METHODS	Investigators , patients , study staff , and those assessing outcomes were masked to treatment group .
METHODS	All participants who received one dose of study drug were included in the primary intention-to-treat efficacy and safety analyses .
METHODS	The main outcomes were the proportion of patients with plasma HIV-1 RNA less than 50 copies per mL at week 48 as defined by the the US Food and Drug Adminstration ( FDA ) snapshot algorithm ( pre-specified non-inferiority margin of 12 % ) and pre-specified renal and bone endpoints at 48 weeks .
METHODS	These studies are registered with ClinicalTrials.gov , numbers NCT01780506 and NCT01797445 .
RESULTS	We recruited patients from Jan 22 , 2013 , to Nov 4 , 2013 ( 2175 screened and 1744 randomly assigned ) , and gave treatment to 1733 patients ( 866 given E/C/F / tenofovir alafenamide and 867 given E/C/F / tenofovir disoproxil fumarate ) .
RESULTS	E/C/F / tenofovir alafenamide was non-inferior to E/C/F / tenofovir disoproxil fumarate , with 800 ( 92 % ) of 866 patients in the tenofovir alafenamide group and 784 ( 90 % ) of 867 patients in the tenofovir disoproxil fumarate group having plasma HIV-1 RNA less than 50 copies per mL ( adjusted difference 20 % , 95 % CI -07 to 47 ) .
RESULTS	Patients given E/C/F / tenofovir alafenamide had significantly smaller mean serum creatinine increases than those given E/C/F / tenofovir disoproxil fumarate ( 008 vs 012 mg/dL ; p < 00001 ) , significantly less proteinuria ( median % change -3 vs 20 ; p < 00001 ) , and a significantly smaller decrease in bone mineral density at spine ( mean % change -130 vs -286 ; p < 00001 ) and hip ( -066 vs -295 ; p < 00001 ) at 48 weeks .
CONCLUSIONS	Through 48 weeks , more than 90 % of patients given E/C/F / tenofovir alafenamide or E/C/F / tenofovir disoproxil fumarate had virological success .
CONCLUSIONS	Renal and bone effects were significantly reduced in patients given E/C/F / tenofovir alafenamide .
CONCLUSIONS	Although these studies do not have the power to assess clinical safety events such as renal failure and fractures , our data suggest that E/C/F / tenofovir alafenamide will have a favourable long-term renal and bone safety profile .
BACKGROUND	Gilead Sciences .

###24902822
OBJECTIVE	Family functioning impairment is widely reported in the eating disorders literature , yet few studies have examined the role of family functioning in treatment for adolescent anorexia nervosa ( AN ) .
OBJECTIVE	This study examined family functioning in two treatments for adolescent AN from multiple family members ' perspectives .
METHODS	Participants were 121 adolescents with AN ages 12-18 from a randomized-controlled trial comparing family-based treatment ( FBT ) to individual adolescent-focused therapy ( AFT ) .
METHODS	Multiple clinical characteristics were assessed at baseline .
METHODS	Family functioning from the perspective of the adolescent and both parents was assessed at baseline and after 1 year of treatment .
METHODS	Full remission from AN was defined as achieving both weight restoration and normalized eating disorder psychopathology .
RESULTS	In general , families dealing with AN reported some baseline impairment in family functioning , but average ratings were only slightly elevated compared to published impaired functioning cutoffs .
RESULTS	Adolescents ' perspectives on family functioning were the most impaired and were generally associated with poorer psychosocial functioning and greater clinical severity .
RESULTS	Regardless of initial level of family functioning , improvements in several family functioning domains were uniquely related to full remission at the end of treatment in both FBT and AFT .
RESULTS	However , FBT had a more positive impact on several specific aspects of family functioning compared to AFT .
CONCLUSIONS	Families seeking treatment for adolescent AN report some difficulties in family functioning , with adolescents reporting the greatest impairment .
CONCLUSIONS	Although FBT may be effective in improving some specific aspects of family dynamics , remission from AN was associated with improved family dynamics , regardless of treatment type .

###24909598
OBJECTIVE	To evaluate the effects of subarachnoid propofol administration ( SPA ) on analgesia , sedation , ataxia , cardiopulmonary , blood gas variables , and its application in ovariectomy in Jennies .
METHODS	Prospective , randomized , clinical trial .
METHODS	Adult Jennies ( n = 20 ; 100-120kg ; 5-7 years old ) .
METHODS	In study 1 , 5 Jennies had SPA ( n = 5 ; group 1 ) through Tuohy catheter , and another 5 control Jennies had normal saline subarachnoid administration ( n = 5 ; group 2 ) .
METHODS	In study 2 , 10 Jennies had SPA and ovariectomy ( n = 10 ; group 3 ) .
METHODS	In groups 1 and 3 analgesia , sedation and ataxia scores , cardiopulmonary and blood gas variables were recorded at different intervals before and after PSA .
METHODS	In group 2 , only cardiopulmonary and blood gas variables were recorded .
RESULTS	SPA produced pronounced analgesia , mild sedation and minimal ataxia .
RESULTS	Heart rate ( HR ) , respiratory rate ( RR ) , pulse rate ( PR ) , rectal temperature ( RT ) , arterial blood pH , PaO2 , and PaCO2 were not significantly different from base line values after subarachnoid administration of either propofol or normal saline .
CONCLUSIONS	SPA was found to be useful , efficient and feasible procedure for ovariectomy through standing flank laparotomy in Jennies .

###24496169
OBJECTIVE	The aim of this study was to determine the minimum effective volume ( MEV ) of combined lidocaine 1.0 % - bupivacaine 0.25 % with epinephrine 5 g/mL in 90 % of patients ( MEV90 ) for ultrasound-guided subparaneural popliteal sciatic nerve block .
METHODS	All subjects received an ultrasound-guided subparaneural popliteal sciatic nerve block ( at the neural bifurcation ) with combined lidocaine 1.0 % - bupivacaine 0.25 % and epinephrine 5 g/mL .
METHODS	Using an out-of-plane technique , a 17-gauge , 8-cm Tuohy needle was advanced until its tip was positioned between the tibial and peroneal nerves inside the paraneural sheath .
METHODS	Volume assignment was carried out using a biased coin design , up-and-down sequential method , where the volume of local anesthetic administered to each patient depended on the response of the previous one .
METHODS	In case of failure , the next subject received a higher volume ( defined as the previous volume with an increment of 3.0 mL ) .
METHODS	If the previous patient had a successful block , the next subject was randomized to a lower volume ( defined as the previous volume with a decrement of 3.0 mL ) , with a probability of b = 0.11 , or the same volume , with a probability of 1 - b = 0.89 .
METHODS	Using a composite scale encompassing sensory and motor block , success was defined , at 30 minutes , as a minimal score of 6 points ( out of 8 points ) .
METHODS	The 6-point score was intended to mirror successful postoperative analgesia .
METHODS	Patients undergoing surgery of the leg , ankle , or foot were prospectively enrolled until 45 successful blocks were obtained .
RESULTS	Fifty-two patients were recruited for this study .
RESULTS	Using isotonic regression and bootstrap confidence interval , the MEV90 of combined lidocaine 1.0 % - bupivacaine 0.25 % with epinephrine 5 g/mL was estimated to be 13.3 mL ( 95 % confidence interval , 10.2-16 .4 mL ) .
CONCLUSIONS	For ultrasound-guided subparaneural ( analgesic ) popliteal sciatic nerve block , the MEV90 of combined lidocaine 1.0 % - bupivacaine 0.25 % with epinephrine 5 g/mL is 13.3 mL ( 95 % confidence interval , 10.2-16 .4 mL ) .

###24474396
BACKGROUND	Thrombotic microangiopathy ( TMA ) is a complication that developed in some patients receiving 12 Gy total body irradiation ( TBI ) in addition to lymphodepleting preparative chemotherapy prior to infusion of autologous tumor-infiltrating lymphocytes ( TIL ) with high-dose aldesleukin ( IL-2 ) .
BACKGROUND	This article describes the incidence , presentation , and course of radiation-associated TMA .
METHODS	The data for patients with metastatic melanoma who received ACT with TIL plus aldesleukin following myeloablative chemotherapy and 12-Gy TBI was examined , in order to look at patient characteristics and the natural history of TMA .
RESULTS	The median time to presentation was approximately 8 months after completing TBI .
RESULTS	The estimated cumulative incidence of TMA was 31.2 % ( median follow-up of 24 months ) .
RESULTS	Noninvasive criteria for diagnosis included newly elevated creatinine levels , new-onset hypertension , new-onset anemia , microscopic hematuria , thrombocytopenia , low haptoglobin , and elevated lactate dehydrogenase values .
RESULTS	Once diagnosed , patients were managed with control of their hypertension with multiple agents and supportive red blood cell transfusions .
RESULTS	TMA typically stabilized or improved and no patient progressed to dialysis .
RESULTS	TMA was associated with a higher probability of an antitumor response .
CONCLUSIONS	TMA occurs in approximately a third of patients treated with a lymphodepleting preparative chemotherapy regimen with TBI prior to autologous T cell therapy .
CONCLUSIONS	The disease has a variable natural history , however , no patient developed end-stage renal failure .
CONCLUSIONS	Successful management with supportive care and aggressive hypertension control is vital to the safe application of a systemic therapy that has shown curative potential for patients with disseminated melanoma .

###24553022
BACKGROUND	The present study compared the effect of bupivacaine and bupivacaine + sufentanil on hemodynamic parameters and characteristics of spinal anesthesia in elderly patients undergoing transurethral resection of the prostate ( TURP ) under spinal anesthesia .
METHODS	The study included 40 American Society of Anesthesiologists ( ASA ) I-III patients scheduled to undergo TURP .
METHODS	Patients were blindly and randomly divided into two groups .
METHODS	Group B ( n = 20 ) received 10 mg of intrathecal bupivacaine and group BS ( n = 20 ) received 7.5 mg of bupivacaine + 5 g of sufentanil .
METHODS	Sensory and motor block characteristics , hemodynamic changes , side effects , and time to first analgesic requirement were recorded .
METHODS	No differences in mean arterial pressure or heart rate , time for sensory blockade to reach the T10 level , and maximum sensory level were observed between the two groups .
METHODS	The time to first analgesic request was longer in group BS ( P < 0.05 ) .
METHODS	Motor block was significantly higher in group B ( P < 0.05 ) .
METHODS	In terms of side effects , no statistically significant differences occurred between the groups .
CONCLUSIONS	Similar hemodynamic stability and sufficient level of sensory blockade were provided by bupivacaine and bupivacaine + sufentanil used for spinal anesthesia in patients undergoing TUR .
CONCLUSIONS	Due to the fact that less motor block was observed and the time to first analgesic request was longer , the combination of bupivacaine + sufentanil might be appropriate for patients undergoing TUR .

###24872255
BACKGROUND	This study aimed to assess acute and chronic effects of right ventricular mid-septum ( RVS ) versus right ventricular apex ( RVA ) pacing on left ventricular ( LV ) mechanical dyssynchrony using phase analysis of gated single photon emission computed tomography myocardial perfusion imaging ( MPI ) .
METHODS	Thirty-nine patients with complete atrioventricular ( AV ) block , who were indicated for permanent pacing , were recruited and randomized to receive RVA ( n = 20 ) or RVS ( n = 19 ) pacing .
METHODS	All patients underwent MPI at 1 week and 6 months after pacemaker implantation .
METHODS	LV dyssynchrony and cardiac function were assessed by MPI and compared between the two groups .
RESULTS	There were no significant differences in baseline characteristics between the RVS and RVA groups .
RESULTS	The paced QRS duration was significantly longer in the RVA group than in the RVS group .
RESULTS	LV dyssynchrony parameters were not significantly different between the groups at the 1-week follow-up , but they were significantly smaller in the RVS group than in the RVA group at the 6-month follow-up .
RESULTS	LV dyssynchrony parameters significantly decreased in the RVS group from the 1-week follow-up to the 6-month follow-up , but were unchanged in the RVA group .
RESULTS	No differences in LV function parameters were observed between the groups at the 1-week and 6-month follow-ups .
CONCLUSIONS	RVS pacing produces better electrical and mechanical synchrony than RVA pacing for patients with complete AV block .

###25573527
BACKGROUND	Polyneuropathy , organomegaly , endocrinopathy , M-protein and skin changes ( POEMS ) syndrome is a fatal systemic disorder associated with plasma cell dyscrasia and the overproduction of the vascular endothelial growth factor ( VEGF ) .
BACKGROUND	Recently , the prognosis of POEMS was substantially improved by introduction of therapeutic intervention for myeloma .
BACKGROUND	However , no randomised clinical trial has been performed because of the rarity and severity of the disease .
METHODS	The Japanese POEMS syndrome with Thalidomide ( J-POST ) Trial is a phase II/III multicentre , double-blinded , randomised , controlled trial that aims to evaluate the efficacy and safety of a 24-week treatment with thalidomide in POEMS syndrome , with an additional 48-week open-label safety study .
METHODS	Adults with POEMS syndrome who have no indication for transplantation are assessed for eligibility at 12 tertiary neurology centres in Japan .
METHODS	Patients who satisfy the eligibility criteria are randomised ( 1:1 ) to receive thalidomide ( 100-300mg daily ) plus dexamethasone ( 12mg/m ( 2 ) on days 1-4 of a 28-day cycle ) or placebo plus dexamethasone .
METHODS	Both treatments were administered for 24weeks ( six cycles ; randomised comparative study period ) .
METHODS	Patients who complete the randomised study period or show subacute deterioration during the randomised period participate in the subsequent 48-week open-label safety study ( long-term safety period ) .
METHODS	The primary end point of the study is the reduction rate of serum VEGF levels at 24weeks .
BACKGROUND	The protocol was approved by the Institutional Review Board of each hospital .
BACKGROUND	The trial was notified and registered at the Pharmaceutical and Medical Devices Agency , Japan ( No. 22-1716 ) .
BACKGROUND	The J-POST Trial is currently ongoing and is due to finish in August 2015 .
BACKGROUND	The findings of this trial will be disseminated through peer-reviewed publications and conference presentations and will also be disseminated to participants .
BACKGROUND	UMIN000004179 and JMA-IIA00046 .

###24743579
BACKGROUND	Remote ischemic preconditioning ( RIPC ) may confer the protection in critical organs .
BACKGROUND	The authors hypothesized that limb RIPC would reduce lung injury in patients undergoing pulmonary resection .
METHODS	In a randomized , prospective , parallel , controlled trial , 216 patients undergoing elective thoracic pulmonary resection under one-lung ventilation with propofol-remifentanil anesthesia were randomized 1:1 to receive either limb RIPC or conventional lung resection ( control ) .
METHODS	Three cycles of 5-min ischemia/5-min reperfusion induced by a blood pressure cuff served as RIPC stimulus .
METHODS	The primary outcome was PaO2/FIO2 .
METHODS	Secondary outcomes included other pulmonary variables , the incidence of in-hospital complications , markers of oxidative stress , and inflammatory response .
RESULTS	Limb RIPC significantly increased PaO2/FIO2 compared with control at 30 and 60 min after one-lung ventilation , 30 min after re-expansion , and 6 h after operation ( 238 52 vs. 192 67 , P = 0.03 ; 223 66 vs. 184 64 , P = 0.01 ; 385 61 vs. 320 79 , P = 0.003 ; 388 52 vs. 317 46 , P = 0.001 , respectively ) .
RESULTS	In comparison with control , it also significantly reduced serum levels of interleukin-6 and tumor necrosis factor - at 6 , 12 , 24 , and 48 h after operation and malondialdehyde levels at 60 min after one-lung ventilation and 30 min after re-expansion ( all P < 0.01 ) .
RESULTS	The incidence of acute lung injury and the length of postoperative hospital stay were markedly reduced by limb RIPC compared with control ( all P < 0.05 ) .
CONCLUSIONS	Limb RIPC attenuates acute lung injury via improving intraoperative pulmonary oxygenation in patients without severe pulmonary disease after lung resection under propofol-remifentanil anesthesia .

###25425451
OBJECTIVE	To test our hypothesis that initiating therapy with a combination of agents known to improve insulin secretion and insulin sensitivity in subjects with new-onset diabetes would produce greater , more durable reduction in glycated haemoglobin ( HbA1c ) levels , while avoiding hypoglycaemia and weight gain , compared with sequential addition of agents that lower plasma glucose but do not correct established pathophysiological abnormalities .
METHODS	Drug-nave , recently diagnosed subjects with type 2 diabetes mellitus ( T2DM ) were randomized in an open-fashion design in a single-centre study to metformin/pioglitazone/exenatide ( triple therapy ; n = 106 ) or an escalating dose of metformin followed by sequential addition of sulfonylurea and glargine insulin ( conventional therapy ; n = 115 ) to maintain HbA1c levels at < 6.5 % for 2years .
RESULTS	Participants receiving triple therapy experienced a significantly greater reduction in HbA1c level than those receiving conventional therapy ( 5.95 vs. 6.50 % ; p < 0.001 ) .
RESULTS	Despite lower HbA1c values , participants receiving triple therapy experienced a 7.5-fold lower rate of hypoglycaemia compared with participants receiving conventional therapy .
RESULTS	Participants receiving triple therapy experienced a mean weight loss of 1.2 kg versus a mean weight gain of 4.1 kg ( p < 0.01 ) in those receiving conventional therapy .
CONCLUSIONS	The results of this exploratory study show that combination therapy with metformin/pioglitazone/exenatide in patients with newly diagnosed T2DM is more effective and results in fewer hypoglycaemic events than sequential add-on therapy with metformin , sulfonylurea and then basal insulin .

###26141495
BACKGROUND	A surgical glove will protect surgeons and patients only if the glove 's integrity remains intact .
BACKGROUND	However , several studies have demonstrated that undetected micro-perforations of surgical gloves are common .
BACKGROUND	Because of the possibility of surgical glove puncture , an antimicrobial surgical glove was developed .
BACKGROUND	The aim of this laboratory based experimental study was to assess the antibacterial efficacy of the interior chlorhexidine-gluconate ( CHG ) - coat of an antimicrobial synthetic polyisoprene surgical glove by using a standardized microbiological challenge .
METHODS	Sixteen healthy adult participants donned one antimicrobial surgical glove and one non-antimicrobial surgical glove randomly allocated to their dominant and non-dominant hand following a crossover design .
METHODS	During a 2-h wear time , participants performed standardized finger and hand movements .
METHODS	Thereafter , the interior surface of excised fingers of the removed gloves was challenged with 8.00 log10 cfu/mLS .
METHODS	aureus ( ATCC 6538 ) or K. pneumoniae ( ATCC 4352 ) , respectively .
METHODS	The main outcome measure was the viable mean log10 cfu counts of the two glove groups after 5min contact with the interior glove 's surface .
RESULTS	When comparing an antimicrobial glove against an untreated reference glove after 2-h simulated use wear-time , a mean reduction factor of 6.24 log10 ( S. aureus ) and 6.22 log10 ( K. pneumoniae ) was achieved after 5min contact .
CONCLUSIONS	These results demonstrate that wearing antibacterial gloves on hands does not negatively impact their antibacterial activity after 2-h of wear .
CONCLUSIONS	This may have a potential benefit for patient safety in case of glove puncture during surgical procedures .

###24351556
OBJECTIVE	To explore the influence of rosa roxburghii tratt preparation on immune function of arseniasis patients caused by burning coal .
METHODS	According to the diagnosis standard for endemic arseniasis ( WS/T 211-2001 ) , 62 cases of arseniasis patients who resided in endemic arseniasis area in Guizhou province were selected and divided stratified randomly into two groups : rosa roxburghii tratt juice treatment group and superoxide dismutase ( SOD ) - enriched rosa roxburghii tratt juice treatment group , with 31 patients in each group.Each patient took 120 ml/d rosa roxburghii tratt preparation or SOD-enriched rosa roxburghii tratt orally for one month .
METHODS	Another 30 healthy residents from a neighbour township 12 km away where arsenic was not prevalent were selected as controls .
METHODS	A 2 ml blood and 50 ml urine samples were collected from individuals and the urine arsenic contents , peripheral blood T-lymphocyte subsets ( CD3 ( + ) , CD4 ( + ) , CD8 ( + ) T cell ) , serum immunoglobulin ( IgG , IgM , IgA ) and complement ( C3 , C4 ) were detected .
METHODS	The differences between more than two groups on above indicators were compared .
METHODS	The correlations between urinary arsenic and immune parameters were analyzed .
RESULTS	Among the rosa roxburghii tratt juice group , SOD-enriched rosa roxburghii tratt juice before intervention group and the control group , the levels of urine arsenic were ( 76.55 23.02 ) , ( 72.60 25.91 ) and ( 26.33 11.30 ) g/g Cr respectively and IgG were ( 11.31 1.68 ) , ( 11.35 1.94 ) and ( 9.23 1.75 ) g/L respectively .
RESULTS	The differences were statistically significant ( F values were 82.01 , 13.82 , both P values < 0.05 ) .
RESULTS	After intervention with rosa roxburghii tratt preparation , the levels of urine arsenic were ( 53.21 16.51 ) and ( 51.72 17.70 ) g/g Cr , both decreased than before intervention ( t values were 5.80 and 3.78 , both P values < 0.05 ) .
RESULTS	The levels of CD3 ( + ) were ( 44.47 7.14 ) % , ( 43.44 6.61 ) % and ( 70.78 5.26 ) % , CD4 ( + ) were ( 29.87 5.67 ) % , ( 29.42 5.87 ) % and ( 46.08 5.87 ) % , CD4 ( + ) / CD8 ( + ) were ( 1.25 0.42 ) , ( 1.22 0.39 ) and ( 1.79 0.26 ) and C4 were ( 0.13 0.08 ) , ( 0.13 0.09 ) and ( 0.20 0.11 ) g/L respectively among the two treatment group before intervention and the control group .
RESULTS	The differences were significant ( F values were 178.04 , 76.71 , 23.13 and 5.26 , all P values < 0.05 ) .
RESULTS	After intervention , the levels of CD3 ( + ) were ( 59.73 7.38 ) % and ( 66.31 7.57 ) % , CD4 ( + ) were ( 34.00 7.97 ) % and ( 39.11 5.81 ) % , CD4 ( + ) / CD8 ( + ) were ( 1.41 0.37 ) and ( 1.58 0.26 ) , all increased than before intervention ( t values were 12.47 , 25.18 , 5.41 , 10.47 , 3.22 and 5.05 , all P values < 0.05 ) .
RESULTS	The levels of urine arsenic and CD3 ( + ) , CD4 ( + ) , CD4 ( + ) / CD8 ( + ) , C4 were inversely correlated correlation , while positive correlation existed between the level of urine arsenic and IgG ( r values were -0.68 , -0.56 , -0.51 , -0.43 and 0.36 , all P values < 0.01 ) .
CONCLUSIONS	The level of urinary arsenic level is closely related to immune function suppression in arseniasis patients caused by burning coal , rosa roxburghii tratt preparation can effectively improve immune function of arseniasis patients .

###25106776
BACKGROUND	Oral mucositis is one of the common complications of cancer chemotherapy and about 40 % of the patients who take chemotherapy protocols , experience this irritating problem .
BACKGROUND	The purpose of this study was to draw comparison between the therapeutic effects of our treatment modalities ( topical steroid , honey , honey plus coffee ) in patients suffering from oral mucositis .
METHODS	This was a double blinded randomised clinical trial of a total of 75 eligible adult participants which they randomly fell into three treatment groups .
METHODS	For all the participants a syrup-like solution was prepared .
METHODS	Each 600 grams of the product consisted of `` 20 eight-mg Betamethasone solution ampoules '' in the Steroid ( S ) group , `` 300 grams of honey plus 20 grams of instant coffee '' in the Honey plus Coffee ( HC ) group , and `` 300 grams of honey '' for the Honey ( H ) group .
METHODS	The participants were told to sip 10 ml of the prescribed product , and then swallow it every three hours for one week .
METHODS	Severity of lesions was clinically evaluated before the treatment and also one week after the initiation of the intervention .
METHODS	This study adhered to the principles of the Declaration of Helsinki and guidelines of Good Clinical Practice .
RESULTS	This study showed that all three treatment regimens reduce the severity of lesions .
RESULTS	The best reduction in severity was achieved in HC group .
RESULTS	H group and S group took the second and third places .
RESULTS	In other words , honey plus coffee regimen was the most effective modality for the treatment of oral mucositis .
CONCLUSIONS	Oral mucositis can be successfully treated by a combination of honey and coffee as an alternative medicine in a short time .
CONCLUSIONS	Further investigations are warranted in this field .
BACKGROUND	Iranian Registry of Clinical Trials IRCT : 201104074737N3 , ( 9 May 2011 ) .

###24286192
OBJECTIVE	The purpose of this study was to investigate if the levonorgestrel-impregnated intrauterine device ( LNG-IUS , Mirena ( ) ) is safe and effective as therapy for low-risk and medium-risk endometrial hyperplasia compared with oral medroxyprogesterone ( MPA ) .
METHODS	A multicentre randomised trial .
METHODS	Norway .
METHODS	In all , 170 women aged 30-70years with low - or medium-risk endometrial hyperplasia who met inclusion criteria .
METHODS	Patients were randomly assigned to one of three treatment arms : LNG-IUS ; oral MPA 10mg administered for 10days per cycle , or continuous oral MPA 10mg daily , for 6months .
METHODS	The primary outcome measure was normalisation or persisting hyperplasia .
RESULTS	After 6months all three treatment regimens showed significant effect when the outcome was evaluated as therapy response or not ( P < 0.001 ) .
RESULTS	Responses were obtained for all the women in the LNG-IUS group ( 53/53 , 95 % CI 0.93-1 .0 ) and for 96 % of the women in the continuous oral group ( 46/48 , 95 % CI 0.86-0 .99 ) .
RESULTS	Only 69 % of the women in the cyclic oral group were responders ( 36/52 , 95 % CI 0.55-0 .81 ) .
RESULTS	Adverse effects were relatively common with minimal differences between therapy groups .
CONCLUSIONS	In the first trial of its kind , women treated with the LNG-IUS showed histologically normal endometrium after 6months of therapy for endometrial hyperplasia .
CONCLUSIONS	Cyclical progestogens are found to be less effective compared with continuous oral therapy and LNG-IUS and should not be used for this purpose .

###24818764
OBJECTIVE	n-3 polyunsaturated fatty acids reduce insulin resistance , lipogenesis , and inflammation , which are features of nonalcoholic steatohepatitis ( NASH ) .
OBJECTIVE	Ethyl-eicosapentanoic acid ( EPA-E ) is a synthetic polyunsaturated fatty acid that reduces hypertriglyceridemia .
OBJECTIVE	We report the final results of a phase 2b multicenter , prospective , double-blind , randomized , placebo-controlled trial of EPA-E for NASH .
METHODS	Our study , performed at 37 sites in North America , included subjects with NASH and nonalcoholic fatty liver disease ( NAFLD ) activity scores 4 , with minimum scores of 1 for steatosis and inflammation , along with either ballooning or at least stage 1a fibrosis .
METHODS	A total of 243 subjects were randomly assigned to groups given placebo ( n = 75 ) , low-dosage EPA-E ( 1800 mg/d ; n = 82 ) , or high-dosage EPA-E ( 2700 mg/d ; n = 86 ) for 12 months .
METHODS	Subjects were examined at 4-week intervals for 3 months , 6-week intervals for the next 3 months , and every 3 months thereafter , until 1 month after the last dose was taken .
METHODS	Liver biopsies were collected 2 weeks after the last dose of EPA-E or placebo .
METHODS	The primary efficacy end point was NAFLD activity score 3 , without worsening of fibrosis ; or a decrease in NAFLD activity score by 2 with contribution from > 1 parameter , without worsening of fibrosis , 1 year after the last dose of EPA-E or placebo was given .
RESULTS	Similar proportions of subjects in each group met the primary end point ( 40 % , 37 % , and 35.9 % for placebo , low-dosage , and high-dosage EPA-E , respectively ) .
RESULTS	EPA-E had no significant effects on steatosis , inflammation , ballooning , or fibrosis scores .
RESULTS	There were no significant effects on levels of liver enzymes , insulin resistance , adiponectin , keratin 18 , high-sensitivity C-reactive protein , or hyaluronic acid .
RESULTS	High-dosage EPA-E reduced levels of triglyceride ( -6.5 mg/dL vs an increase of 12 mg/dL in the placebo group ; P = .03 ) .
RESULTS	There were no treatment-related serious adverse events .
CONCLUSIONS	In a phase 2 trial , EPA-E had no significant effect on the histologic features of NASH .
CONCLUSIONS	EPA-E reduced subjects ' levels of triglyceride compared with placebo , without any increase in serious adverse events .
CONCLUSIONS	Clinicaltrials.gov Number : 01154985 .

###25548846
BACKGROUND	Various preparations of botulinum toxin type A ( BTX-A ) are used to reduces glabellar ( frown ) lines .
BACKGROUND	However , dose-related safety and efficacy of intramuscular injections of a widely used , locally produced BTX-A in China has not been established .
OBJECTIVE	Assessment of dose-dependent safety and efficacy of Chinese botulinum toxin type A ( Hengli BTX-A [ HBTX-A ] ) intramuscular injections on glabellar lines .
METHODS	Four hundred eighty-eight BTX-A-naive participants were included in the double-blind trial and randomly divided into placebo ( n = 122 ) , low-dose ( n = 183 ) , and high-dose ( n = 183 ) treatment groups for injection with saline solution , 10 units and 20 units of HBTX-A , respectively , at 4 sites in the corrugator muscle and 1 site in the procerus muscle .
METHODS	Outcomes were recorded before treatment and after 7 , 30 , 60 , and 120 days , including glabellar line severity at maximum contraction and relaxation .
RESULTS	Significantly greater improvement was observed in both HBTX-A groups in comparison with the placebo group ( p < .05 ) .
RESULTS	Better efficacy was obtained in the high-dose treatment group .
RESULTS	More participants developed adverse events after treatment with HBTX-A doses , than with the placebo ( p < .05 ) .
CONCLUSIONS	Twenty-unit HBTX-A provided optimal improvement in glabellar lines , and its use might minimize injection frequency while maintaining acceptable safety .

###24789134
BACKGROUND	While energy devices are ubiquitous in the operating room , they remain poorly understood and can result in significant complications .
BACKGROUND	The purpose of this study was to estimate the extent to which adding a novel bench-top component improves learning of SAGES ' Fundamental Use of Surgical Energy ( FUSE ) electrosurgery curriculum among surgical trainees .
METHODS	Surgical residents participated in a 1-h didactic electrosurgery ( ES ) course , based on the FUSE curriculum .
METHODS	They were then randomized to one of two groups : an unstructured hands-on session where trainees used ES devices ( control group ) or a goal-directed hands-on training session ( Sim group ) .
METHODS	Pre - and post-curriculum ( immediate and at 3 months ) assessments included knowledge of ES ( multiple-choice examination ) , self-perceived competence for each of the 35 course objectives ( questionnaire ) , and self-perceived comfort with performance of seven tasks related to safe use of ES .
METHODS	Data expressed as median [ interquartile range ] , * p < 0.05 .
RESULTS	56 ( 29 control ; 27 Sim ) surgical trainees completed the curriculum and assessments .
RESULTS	Baseline characteristics , including pre-curriculum exam and questionnaire scores , were similar .
RESULTS	Total score on the exam improved from 46 % [ 40 ; 54 ] to 84 % [ 77 ; 91 ] * for the entire cohort , with higher immediate post-curriculum scores in the Sim group compared to controls ( 89 % [ 83 ; 94 ] vs. 83 % [ 71 ; 86 ] * ) .
RESULTS	At 3 months , performance on the exam declined in both groups , but remained higher in the Sim group ( 77 % [ 69 ; 90 ] vs 60 % [ 51 ; 80 ] * ) .
RESULTS	Participants in both groups reported feeling greater comfort and competence post-curriculum ( immediate and at 3 months ) compared to baseline .
RESULTS	This improvement was greater in the Sim group with a higher proportion feeling `` Very Comfortable '' or `` Fully Competent '' ( Sim : 3/7 tasks and 28/35 objectives ; control : 0/7 tasks and 10/35 objectives ) .
CONCLUSIONS	A FUSE-based curriculum improved surgical trainees ' knowledge and comfort in the safe use of electrosurgical devices .
CONCLUSIONS	The addition of a structured interactive bench-top simulation component further improved learning and retention at 3 months .

###24902983
OBJECTIVE	To evaluate the efficacy and safety of USL255 , Qudexy ( ) XR ( topiramate ) extended-release capsules , as an adjunctive treatment for refractory partial-onset seizures ( POS ) in adults taking one to three concomitant antiepileptic drugs .
METHODS	In this global phase III study ( PREVAIL ; NCT01142193 ) , 249 adults with POS were randomized 1:1 to once-daily USL255 ( 200 mg/day ) or placebo .
METHODS	The primary and key secondary efficacy endpoints were median percent reduction in weekly POS frequency and responder rate ( proportion of patients with 50 % reduction in seizure frequency ) .
METHODS	Seizure freedom was also assessed .
METHODS	Safety ( adverse events , clinical and laboratory findings ) , as well as treatment effects on quality of life ( QOLIE-31-P ) and clinical global impression of change ( CGI-C ) , were evaluated .
RESULTS	Across the entire 11-week treatment phase , USL255 significantly reduced the median percent seizure frequency and significantly improved responder rate compared with placebo .
RESULTS	Efficacy over placebo was observed early in treatment , in patients with highly refractory POS , and in those with the most debilitating seizure types ( i.e. , complex partial , partial secondarily generalized ) .
RESULTS	USL255 was safe and generally well tolerated with a low incidence of neurocognitive adverse events .
RESULTS	USL255 was associated with significant clinical improvement without adversely affecting quality of life .
CONCLUSIONS	The PREVAIL phase III clinical study demonstrated that once-daily USL255 ( 200 mg/day ) significantly improved seizure control and was safe and generally well tolerated with few neurocognitive side effects .

###25847557
BACKGROUND	Hypertension is one of the most common chronic diseases .
BACKGROUND	Hypertensive patients who intend to control blood pressure need professional medical assistance .
BACKGROUND	Auricular acupressure is a patient-dependent task , wherein a person does not have to rely on a healthcare professional to self-perform the task .
OBJECTIVE	To evaluate the effects of auricular acupressure on heart rate variability ( HRV ) and quality of life ( QoL ) in patients with hypertension .
METHODS	A randomized controlled trial with permuted block randomization was used .
METHODS	In total , 150 participants from a medical teaching hospital were randomly assigned to the experimental group that received auricular acupressure for 10 weeks , and the control group that received only routine care of equal duration .
METHODS	Outcomes were assessed through HRV parameters , heart rate , blood pressure , and QoL before and after the auricular acupressure intervention .
RESULTS	After the adjustment of disease duration and mental health , a significant difference existed between the two groups in body pain ( p = .03 ) and mental health ( p = .002 ) of QoL , but not in HRV parameters , heart rate , blood pressure , and overall QoL ( p > .05 ) .
CONCLUSIONS	Acupressure can be applied at the acupoints of shenmen , sympathesis , kidney , liver , heart , and subcortex to improve physical pain and mental health of QoL for hypertensive patients .
CONCLUSIONS	Auricular acupressure is acceptable and feasible although it does not support physiological benefits .
CONCLUSIONS	Further studies are warranted to assure the effects of using auricular acupressure as an adjunctive care for patients with hypertension .

###25010824
BACKGROUND	The treatment of adhesive capsulitis ( AC ) is a well-known , complicated , and long process .
BACKGROUND	Recent studies have shown that pulsed radiofrequency ( PRF ) lesioning of the suprascapular nerve ( SSN ) using a fluoroscopy - or computed tomography-guided technique can alleviate shoulder pain .
BACKGROUND	However , there are no studies of PRF lesioning of the SSN in patients with AC using ultrasound-guided ( UG ) techniques , except for 2 case reports .
BACKGROUND	In this study , we compared the effect of physical therapy alone with physical therapy and PRF lesioning of the SSN using a UG technique .
METHODS	Sixty patients with AC were included in the study .
METHODS	Patients were randomized into the following 2 groups : the intervention group containing patients who received 12 weeks of physical therapy after 1 treatment of PRF lesioning of the SSN , and the control group containing patients who received 12 weeks of physical therapy alone .
METHODS	All outcome measurements including visual analog scale ( VAS ) , shoulder pain and disability index , and passive range of motion ( PROM ) were performed at 1 , 4 , 8 , and 12 weeks after treatment .
RESULTS	Forty-two patients ( 21 patients in each group ) completed the study .
RESULTS	The intervention group had a notably shorter time to onset of significant pain relief ( 6.1 3.4 vs 28.1 9.2 days ; P < 0.001 ) and noticeable reduction of VAS score at week 1 ( 40 % vs 4.7 % ) than the control group ( P < 0.001 ) .
RESULTS	All measured variables in the intervention group and most variables in the control group showed significant improvement from the baseline ( P < 0.05 ) .
RESULTS	A comparison of the 2 groups indicated significantly greater improvement in the intervention group at all times in VAS and shoulder pain and disability index scores ( all P < 0.05 ) , and for most gain of PROM ( P < 0.05 ) .
RESULTS	There were no serious adverse effects or complications in either group .
CONCLUSIONS	This study indicates that the application of PRF lesioning of the SSN using a UG technique combined with physical therapy provided better and faster relief from pain , reduced disability , and improved PROM when compared with physical therapy alone in patients with AC , an effect that persisted for at least 12 weeks .

###24251424
OBJECTIVE	To analyse the influence of serving method on compliance and consumption of nutritional supplement drinks in older adults with cognitive impairment .
BACKGROUND	Oral nutritional supplement drinks have positive benefits on increasing nutritional status in undernourished older people leading to weight gain .
BACKGROUND	However , consumption of these drinks is low and therefore limits their effectiveness .
METHODS	This study was a non-blind randomized control trial where participants either consumed nutritional supplement drinks in a glass/beaker or consumed them through a straw inserted directly into the container .
METHODS	Participants with long-standing cognitive impairment were recruited from nursing homes ( n = 31 ) and hospitals ( n = 14 ) .
METHODS	Participants were randomized to serving method .
METHODS	Nursing and care staff were instructed to give the supplement drinks three times per day on alternate days over a week by the allocated serving method .
METHODS	The researcher weighed the amount of supplement drink remaining after consumption .
METHODS	Data were collected over 12 months in 2011-2012 .
RESULTS	Forty-five people participated in this study , mean age 867 ( sd 75 ) years .
RESULTS	After randomization , there was no significant difference between the baseline characteristics of the two groups .
RESULTS	Participants randomized to consume nutritional drinks from a glass/beaker drank statistically significantly more than those who consumed them via a straw inserted directly into the container .
RESULTS	However , supplements allocated to be given in a glass/beaker were more frequently omitted .
CONCLUSIONS	Nutritional supplement drinks should be given to people with dementia who are able to feed themselves in a glass or a beaker if staffing resources allow ( NIHR CSP ref 31101 ) .

###25427325
OBJECTIVE	To evaluate the efficacy of a 2-week administration of a 0.1 % chlorhexidine mouthwash in the short-term treatment of chronic periodontitis patients and the impact of this product when administered twice by pocket irrigation .
METHODS	Sixty patients were enrolled in a single-centre , placebo-controlled , randomized study with the blind allocation of product to two parallel groups .
METHODS	Clinical assessments were performed , and samples from six selected subgingival sites were collected for microbial analysis by culture at baseline , D15 and D56 .
METHODS	Three of the six sites were randomly selected and were treated by subgingival irrigation with the same 0.1 % chlorhexidine product at D0 and D7 .
METHODS	A subsequent statistical analysis was performed using the paired Student 's t-test and Wilcoxon rank sum test for within-group analyses ; analysis of variance and the Kruskall-Wallis test were used for between-group analyses .
RESULTS	Two-week treatment with a 0.1 % chlorhexidine mouthwash slightly reduced the gingival inflammation associated with periodontitis .
RESULTS	We observed a significant decrease in Gram-negative , facultative anaerobes and micro-aerophiles , and a significant increase in Gram-positive cocci .
RESULTS	No increase in the treatment effect was demonstrated by irrigation of the periodontal pockets .
CONCLUSIONS	The 0.1 % chlorhexidine mouthwash showed limited beneficial effects in the treatment of periodontitis patients .

###24616337
OBJECTIVE	The EUROACTION PLUS trial measured the effectiveness of a nurse-led preventive cardiology programme ( EUROACTION ) offering intensive smoking cessation PLUS optional varenicline for persistent high CVD risk smokers to reduce overall cardiovascular risk compared with usual care ( UC ) in general practice ( GP ) .
RESULTS	A parallel group randomized controlled trial in 20 GP in Italy , Netherlands , Spain , and UK .
RESULTS	Six hundred and ninety-six current smokers , ( 137 vascular disease and 559 high total CVD risk ) , were randomized 350 to EUROACTION PLUS ( EA + ) and 346 to UC .
RESULTS	Specially , trained nurses offered the EUROACTION preventive cardiology programme addressing smoking cessation , diet , physical activity , and risk factor management to reduce overall cardiovascular risk .
RESULTS	The primary endpoint was 7 day point prevalence of self-reported abstinence ( validated breath carbon monoxide < 10 p.p.m. ) at 16 weeks .
RESULTS	Secondary outcomes included dietary habits , physical activity , weight , blood pressure ( BP ) , lipid , and glucose management .
RESULTS	One hundred and seventy-seven ( 51 % ) EA + patients ( 91 % opted to use varenicline ) were abstinent vs. 63 ( 19 % ) in UC ; OR 4.52 ( 95 % CI : 3.20-6 .39 ) .
RESULTS	The Mediterranean diet score of 9 in 149 ( 52 % ) EA + patients vs. 97 ( 37 % ) in UC ; OR 1.84 ( 95 % CI : 1.31-2 .59 ) .
RESULTS	Physical activity target achieved in 46 ( 16 % ) EA + patients vs. 19 ( 7 % ) in UC ; OR 2.48 ( 95 % CI : 1.41-4 .36 ) .
RESULTS	Target BP ( < 140/90 mm Hg ) achieved in 150 ( 52 % ) EA + patients vs. 112 ( 43 % ) in UC , OR 1.47 ( 95 % CI : 1.05-2 .06 ) with no difference in antihypertensive drugs .
RESULTS	There were no differences in management of cholesterol or glucose .
CONCLUSIONS	The EUROACTION preventive cardiology programme in high CVD risk smokers using optional varenicline substantially increased smoking abstinence over 16 weeks and also reduced overall cardiovascular risk compared with UC .
CONCLUSIONS	REC reference : 09/H0402/85 ; EudraCT number : 2009-012451-18 ; http://www.controlled-trials.com/ISRCTN22073647 , 12 February 2014 , date last accessed .

###25175313
OBJECTIVE	Effectiveness of advanced technologies for diabetes management may differ depending on national healthcare models or population characteristics .
OBJECTIVE	In the setting of a cross-national trial , we aimed to compare efficacy of sensor-augmented pump ( SAP ) therapy in the United States ( US ) and Canada .
METHODS	In the clinical trial Sensor-Augmented Pump Therapy for A1C Reduction ( STAR 3 ) , 329 adults with type 1 diabetes were randomly allocated to either SAP or glargine-based multiple daily injection ( MDI ) therapy at 26 US sites ( n = 271 ) and 4 Canadian sites ( n = 58 ) .
METHODS	A bootstrap analysis was performed to confirm significant differences in baseline characteristics .
METHODS	For the primary analysis , we compared the baseline to 1-year change in glycated hemoglobin ( A1C ) between Canadian and US subjects .
RESULTS	At baseline , compared with US subjects , Canadian subjects were more likely to be students ( 19 % vs. 7 % , p < 0.01 ) and to consume alcohol ( 91 % vs. 63 % , p < 0.01 ) .
RESULTS	Although Canadian subjects had greater A1C reductions from baseline compared with US subjects ( p = 0.02 ) , the incremental benefit of SAP was similar in the US ( SAP compared with MDI,-0 .93 % 0.73 % vs.-0 .31 % 0.81 % , p < 0.001 ) and Canada ( -1.14 % 0.72 % vs.-0 .67 % 0.71 % , p < 0.001 ) .
RESULTS	Mean sensor use was significantly higher in Canada than in the US ( 79 % vs. 68 % of the time , p < 0.001 ) .
CONCLUSIONS	Despite differences in baseline characteristics and sensor adherence , SAP efficacy was similar between US and Canadian participants .
CONCLUSIONS	As long as the intervention is administered with a similar level of expertise as was conducted in the trial , it is likely to be applicable in diverse clinical practice settings .

###24368307
OBJECTIVE	To evaluate the effect of intravitreal ciliary neurotrophic factor ( CNTF ) implant on mean macular thickness ( MMT ) in eyes with retinitis pigmentosa using high-resolution Fourier domain optical coherence tomography imaging .
METHODS	A cohort of 8 patients ( CNTF-3 : n = 5 ; CNTF-4 : n = 3 ) enrolled in Neurotech sponsored Phase 2 clinical trial underwent Fourier domain optical coherence tomography imaging .
METHODS	A 3 % change in MMT from baseline or fellow eye was considered as a measurable change .
RESULTS	Two patients enrolled in the CNTF-3 study received low-dose implant .
RESULTS	At 18 months , a change in MMT from -4.47 m to 6 m from baseline was noted .
RESULTS	Six patients received high-dose implant ( CNTF-3 : n = 3 ; CNTF-4 : n = 3 ) .
RESULTS	In CNTF-3 group , 1 eye showed an increase in MMT by 19.25 m ( +7.6 % ) from baseline at 18 months .
RESULTS	In CNTF-4 group , 1 eye had an increase in MMT of 27.08 m ( +11 % ) from baseline at 30 months ; second eye had increase in MMT of 31.36 m ( +12 % ) from contralateral eye .
RESULTS	Amongst these 3 responsive high-dose implant eyes , overall thickening of the retina could not be attributed to any specific retinal layer .
CONCLUSIONS	A heterogeneous dose-dependent response on MMT was noted in eyes treated using intravitreal CNTF implant for retinitis pigmentosa .
CONCLUSIONS	We recommend corroboration of our findings with Neurotech sponsored clinical trial results .

###24919603
OBJECTIVE	To assess the effect of initiating insulin treatment on quality of life of patients with type 2 diabetes ( T2DM ) in the 60-week All-to-Target trial ( NCT00384085 ) .
METHODS	Patient-reported outcomes from a phase IV , multicentre , randomised , open-label , parallel-group study were analysed .
METHODS	Participants were randomised to : insulin glargine with up to one insulin glulisine injection ( G + 1 ) ; insulin glargine with stepwise addition of up to three insulin glulisine injections ( G + 3 ) ; or twice-daily premixed 70/30 insulin protamine-aspart/aspart ( PM-2 ) .
METHODS	Patient-reported outcome questionnaires were administered at weeks 0 , 6 , 12 , 24 , 36 , 48 and 60 .
RESULTS	There were no between-group differences in the Psychosocial Adjustment to Illness State-Self Report ( PAIS-SR ) or in the EuroQoL Group Five-Dimension Self-Report Index Questionnaire ( EQ-5D ) from baseline to week 60 ; however , PAIS-SR scores improved significantly over this period in the G + 3 group ( p = 0.0016 ) and EQ-5D scores worsened significantly in the PM-2 group ( p = 0.02 ) .
RESULTS	Hypoglycemia Fear Survey Behaviour and Worry subscales worsened significantly for all groups , with greater deterioration being observed in the PM-2 group than in the G + 1 group ( Behaviour , p = 0.0050 ; Worry , p = 0.0017 ) and G + 3 groups ( Behaviour , p = 0.0105 ; Worry , p = 0.0016 ) .
RESULTS	Total scores on the Diabetes Quality of Life ( DQoL ) questionnaire improved more in the G + 3 group than in the PM-2 group over the study period ( p = 0.0284 ) , with all groups showing a significant improvement in DQoL score over time .
CONCLUSIONS	Insulin glargine-based regimens showed advantages over premixed insulin in a number of patient-reported outcome measures .
CONCLUSIONS	The potential impact on fear of hypoglycaemia may be of particular relevance when addressing the major barriers to early insulin treatment .

###24942409
BACKGROUND	This study examined the effects of atomoxetine ( ATX ) and OROS methylphenidate ( MPH ) on laboratory measures of inhibitory control and attention in youth with attention-deficit/hyperactivity disorder ( ADHD ) .
BACKGROUND	It was hypothesized that performance would be improved by both treatments , but response profiles would differ because the medications work via different mechanisms .
METHODS	One hundred and two youth ( 77 male ; mean age = 10.5 2.7 years ) with ADHD received ATX ( 1.4 0.5 mg/kg ) and MPH ( 52.4 16.6 mg ) in a randomized , double-blind , crossover design .
METHODS	Medication was titrated in 4-6-week blocks separated by a 2-week placebo washout .
METHODS	Inhibitory control and attention measures were obtained at baseline , following washout , and at the end of each treatment using Conners ' Continuous Performance Test II ( CPT-II ) , which provided age-adjusted T-scores for reaction time ( RT ) , reaction time variability ( RT variability ) , and errors .
METHODS	Repeated-measures analyses of variance were performed , with Time ( premedication , postmedication ) and Treatment type ( ATX , MPH ) entered as within-subject factors .
METHODS	Data from the two treatment blocks were checked for order effects and combined if order effects were not present .
BACKGROUND	Clinicaltrials.gov : NCT00183391 .
RESULTS	Main effects for Time on RT ( p = .03 ) , RTSD ( p = .001 ) , and omission errors ( p = .01 ) were significant .
RESULTS	A significant Drug Time interaction indicated that MPH improved RT , RTSD , and omission errors more than ATX ( p < .05 ) .
RESULTS	Changes in performance with treatment did not correlate with changes in ADHD symptoms .
CONCLUSIONS	MPH has greater effects than ATX on CPT measures of sustained attention in youth with ADHD .
CONCLUSIONS	However , the dissociation of cognitive and behavioral change with treatment indicates that CPT measures can not be considered proxies for symptomatic improvement .
CONCLUSIONS	Further research on the dissociation of cognitive and behavioral endpoints for ADHD is indicated .

###25419887
BACKGROUND	Low back pain is a common and costly health care problem .
BACKGROUND	This pilot study evaluated the sensitivity of the 2-stopwatch and Paris plinth methodologies for assessing time-to-onset of pain relief and flexibility , respectively , with continuous , low-level heatwrap therapy .
METHODS	Subjects aged 18 to 55 years with at least moderate baseline acute low back pain were randomly assigned to either heatwrap or oral placebo for 8 hours .
METHODS	Unheated wrap ( sham ) and oral ibuprofen were included for blinding purposes only .
RESULTS	Sixty-one subjects were randomly assigned to either heatwrap ( n = 26 ) , oral placebo ( n = 25 ) , sham wrap ( n = 5 ) , or oral ibuprofen ( n = 5 ) .
RESULTS	Median time to confirmed first perceptible pain relief and to meaningful pain relief were significantly shorter for the heatwrap group compared with those assigned to oral placebo ( 96.5 vs > 240.0 min and 215.7 vs > 240.0 min , respectively ; P < 0.05 for both ) .
RESULTS	Among subjects receiving the heatwrap , 53.8 % reported first perceptible and meaningful relief , compared with 28.0 % receiving oral placebo .
RESULTS	Subjective measures of pain relief , back stiffness , and global evaluation were more sensitive in detecting treatment differences than the plinth assessments of flexibility , range of motion , and pain .
RESULTS	Three adverse events were reported as mild in severity and considered unrelated to study treatment .
CONCLUSIONS	The 2-stopwatch methodology is a viable approach for assessing onset of analgesia in low back pain ; however , the plinth may not be a reliable method for assessing flexibility .
CONCLUSIONS	Consistent with published studies involving much larger sample sizes , the heatwrap provided significantly faster and sustained pain relief than oral placebo in subjects with acute low back pain .
CONCLUSIONS	Clinical Trial Identifier : NCT01045993 .

###24559814
BACKGROUND	Trikatu is composed of dried fruits of Piper nigrum L and Piper retrofractum Vahl , and dried rhizomes of Zingiber officinale R. Although this preparation has been used to relieve pruritis , pain , and inflammation for a long time , there is no clinical evidence to confirm its efficacy and safety .
BACKGROUND	Therefore , we performed a double-blind , within person-randomized controlled study of 30 healthy volunteers to determine efficacy and safety of topical Trikatu on mosquito bite reactions .
METHODS	All subjects were bitten by Aedes aegypti laboratory mosquitoes on their forearms and they were randomly assigned arms to apply either Trikatu or reference product on the mosquito bite papule .
METHODS	The main outcome was the difference of papule size reduction at 30 min , measured by a caliper , between the Trikatu and reference arms .
METHODS	Pruritis , redness , pain , and patient satisfaction were assessed at 15 , 30 , 60 , 180 , and 360 min as secondary outcomes .
RESULTS	There were no significant differences between treatment and reference arms on any outcome at any time of measurement .
CONCLUSIONS	Trikatu did not show additional effects for relieving mosquito bite reaction as compared with the reference product containing camphor , menthol , and eucalyptus .
CONCLUSIONS	For further study , it is very important to consider a proper selection of subjects , comparator product , and concentration of extract when Trikatu preparation is investigated .

###24918373
BACKGROUND	We assessed the efficacy and safety of brodalumab , a human monoclonal antibody against interleukin-17 receptor A ( IL17RA ) , in a phase 2 , randomized , double-blind , placebo-controlled study involving patients with psoriatic arthritis .
METHODS	We randomly assigned patients with active psoriatic arthritis to receive brodalumab ( 140 or 280 mg subcutaneously ) or placebo on day 1 and at weeks 1 , 2 , 4 , 6 , 8 , and 10 .
METHODS	At week 12 , patients who had not discontinued their participation in the study were offered open-label brodalumab ( 280 mg ) every 2 weeks .
METHODS	The primary end point was 20 % improvement in American College of Rheumatology response criteria ( ACR 20 ) at week 12 .
RESULTS	Of the 168 patients who underwent randomization ( 57 in the brodalumab 140-mg group , 56 in the brodalumab 280-mg group , and 55 in the placebo group ) , 159 completed the double-blind phase and 134 completed 40 weeks of the open-label extension .
RESULTS	At week 12 , the brodalumab 140-mg and 280-mg groups had higher rates of ACR 20 than the placebo group ( 37 % [ P = 0.03 ] and 39 % [ P = 0.02 ] , respectively , vs. 18 % ) ; they also had higher rates of 50 % improvement ( ACR 50 ) ( 14 % [ P = 0.05 ] and 14 % [ P = 0.05 ] vs. 4 % ) .
RESULTS	Rates of 70 % improvement were not significantly higher in the brodalumab groups .
RESULTS	Similar degrees of improvement were noted among patients who had received previous biologic therapy and those who had not received such therapy .
RESULTS	At week 24 , ACR 20 response rates in the brodalumab 140-mg and 280-mg groups were 51 % and 64 % , respectively , as compared with 44 % among patients who switched from placebo to open-label brodalumab ; responses were sustained through week 52 .
RESULTS	At week 12 , serious adverse events had occurred in 3 % of patients in the brodalumab groups and in 2 % of those in the placebo group .
CONCLUSIONS	Brodalumab significantly improved response rates among patients with psoriatic arthritis .
CONCLUSIONS	Larger studies of longer duration are necessary to assess adverse events .
CONCLUSIONS	( Funded by Amgen ; ClinicalTrials.gov number , NCT01516957 . )

###25338187
OBJECTIVE	Prolonged grief disorder ( PGD ) is a potentially disabling condition that affects approximately 10 % of bereaved people .
OBJECTIVE	Grief-focused cognitive behavior therapy ( CBT ) has been shown to be effective in treating PGD .
OBJECTIVE	Although treatments for PGD have focused on exposure therapy , much debate remains about whether exposure therapy is optimal for PGD .
OBJECTIVE	To determine the relative efficacies of CBT with exposure therapy ( CBT/exposure ) or CBT alone for PGD .
METHODS	A randomized clinical trial of 80 patients with PGD attending the outpatient University of New South Wales Traumatic Stress Clinic from September 17 , 2007 , through June 7 , 2010 .
METHODS	All patients received 10 weekly 2-hour group therapy sessions that consisted of CBT techniques .
METHODS	Patients also received 4 individual sessions , in which they were randomized to receive exposure therapy for memories of the death or supportive counseling .
METHODS	Measures of PGD by clinical interview and self-reported measures of depression , cognitive appraisals , and functioning at the 6-month follow-up .
RESULTS	Intention-to-treat analyses at follow-up indicated a significant quadratic timetreatment condition interaction effect ( B [ SE ] , 0.49 [ 0.16 ] ; t120 .16 = 3.08 [ 95 % CI , 0.18-0 .81 ] ; P = .003 ) , indicating that CBT/exposure led to greater PGD reductions than CBT alone .
RESULTS	At follow-up , CBT/exposure led to greater reductions in depression ( B [ SE ] , 0.35 [ 0.12 ] ; t112 .65 = 2.83 [ 95 % CI , 0.11-0 .60 ] ; P = .005 ) , negative appraisals ( B [ SE ] , 0.68 [ 0.25 ] ; t109 .98 = 2.66 [ 95 % CI , 0.17-1 .18 ] ; P = .009 ) , and functional impairment ( B [ SE ] , 0.24 [ 0.08 ] ; t111 .40 = 3.01 [ 95 % CI , 0.08-0 .40 ] ; P = .003 ) than CBT alone .
RESULTS	In terms of treatment completers , fewer patients in the CBT/exposure condition at follow-up ( 14.8 % ) met criteria for PGD than those in the CBT condition ( 37.9 % ) ( odds ratio , 3.51 ; 95 % CI , 0.96-12 .89 ; 2 = 3.81 ; P = .04 ) .
CONCLUSIONS	Including exposure therapy that promotes emotional processing of memories of the death is an important component to achieve optimal reductions in PGD severity .
CONCLUSIONS	Facilitating emotional responses to the death may promote greater changes in appraisals about the loss , which are associated with symptom reduction .
CONCLUSIONS	Promotion of emotional processing techniques in therapies to treat patients with PGD is needed .
BACKGROUND	anzctr.org.au Identifier : ACTRN12609000229279 .

###25127679
OBJECTIVE	Colonoscopy is the recommended screening procedure for first-degree relatives of patients with colorectal cancer ( CRC ) , but few studies have compared its efficacy for CRC detection with that of other screening strategies .
OBJECTIVE	We conducted a controlled randomized trial to compare the efficacy of repeated fecal immunochemical tests ( FITs ) and colonoscopy in detecting advanced neoplasia ( advanced adenoma or CRC ) in family members of patients with CRC .
METHODS	In a prospective study , 1918 first-degree relatives of patients with CRC were randomly assigned ( 1:1 ratio ) to receive a single colonoscopy examination or 3 FITs ( 1/year for 3 years ; OC-Sensor ; cutoff 10 g hemoglobin/g feces , corresponding to 50 ng hemoglobin/mL buffer ) .
METHODS	The strategies were considered to be equivalent if the 95 % confidence interval of the difference for the detection of advanced neoplasia was 3 % .
METHODS	Follow-up analyses were performed to identify false-negative FIT results and interval CRCs .
RESULTS	Of all eligible asymptomatic first-degree relatives , 782 were included in the colonoscopy group and 784 in the FIT group .
RESULTS	In the intention-to-screen analysis , advanced neoplasia was detected in 33 ( 4.2 % ) and 44 ( 5.6 % ) first-degree relatives in the FIT and colonoscopy groups , respectively ( odds ratio = 1.41 ; 95 % confidence interval : 0.88-2 .26 ; P = .14 ) .
RESULTS	In the per-protocol analysis , 28 first-degree relatives ( 3.9 % ) in the FIT group and 43 ( 5.8 % ) in the colonoscopy group had advanced neoplasia ( odds ratio = 1.56 ; 95 % confidence interval : 0.95-2 .56 ; P = .08 ) .
RESULTS	FIT missed 16 of 41 advanced adenomas but no CRCs .
RESULTS	The FIT strategy required endoscopic evaluation of 4-fold fewer individuals to detect 1 advanced neoplasia than the colonoscopy strategy .
CONCLUSIONS	Repeated FIT screening ( 1/year for 3 years ) detected all CRCs and proved equivalent to colonoscopy in detecting advanced neoplasia in first-degree relatives of patients with CRC .
CONCLUSIONS	This strategy should be considered for populations where compliance with FITs is higher than with colonoscopy .
CONCLUSIONS	ClinicalTrials.gov number : NCT01075633 ( COLONFAM Study ) .

###24794696
BACKGROUND	We had for aim to compare the effects of intra-operative opioid analgesia according to the drug kinetics .
METHODS	We conducted a prospective , controlled , randomized , double-blinded trial including 60 patients scheduled for ambulatory multiple third molar avulsion .
METHODS	The general anesthesia , performed with propofol and analgesia was a target-controlled infusion of either remifentanil or sufentanil .
METHODS	The anesthesia was set to reach an optimal bispectral index and adjusted to a clinical target throughout the procedure .
METHODS	The main endpoints were : postoperative request for morphine and other opioids ; postoperative pain ; postoperative adverse effects of opioids .
RESULTS	In the post-operative care unit ( French acronym PACU ) , patients who received remifentanil were extubated earlier ( 17 vs. 26 min . )
RESULTS	, but had more pain and required twice more morphine for analgesia ( 6 vs. 3 mg ) , than those who had received sufentanil .
RESULTS	However , the need for post-surgery oral opioid intake was greater in the sufentanil group , so the overall postoperative opioid consumption and patient satisfaction were identical in both groups .
RESULTS	The time spent in the PACU was also identical for both groups .
CONCLUSIONS	Using an ultra-short kinetic opioid such as remifentanil does not seem useful , since the shorter delay before extubation is compensated by a greater need for morphine in the PACU .

###25050592
OBJECTIVE	The first oxycodone once daily ( OOD ) has been developed and after successful pharmacokinetic characterization , therapeutic efficacy and safety were compared to an established oxycodone twice daily ( OTD : Oxygesic/OxyContin , Mundipharma ) .
METHODS	A randomized , double-blind , multicenter , cross-over , non-inferiority study was conducted in patients ( n = 68 ) with chronic malignant or non-malignant pain .
METHODS	The new OOD was compared to OTD at identical total daily doses ( TDD : 40-120mg / day ) employing intensive , five times daily current pain ( 0-100mm visual analog scale , VAS ) and twice daily 12h recalled pain assessments as well as safety parameters such as nausea and sedation ( VAS ) over 5 days for each treatment ( after a 5day run-in phase ) .
RESULTS	There was no significant difference in analgesic potency detected between the two treatments based on 95 % CI for difference in the daily mean current pain ( -2.09 mm VAS ) over 5 days , determined as -5.09 to 0.91 mm VAS .
RESULTS	A difference 12mm VAS indicated non-inferiority of OOD , i.e. lack of clinically relevant difference in analgesia .
RESULTS	Intake of rescue medication had no effect on study results as evaluated by ANCOVA .
RESULTS	The difference in adverse events ( AEs ) between the two treatments did not reach significance , as 19.1 % and 23.5 % of patients experienced treatment-related AEs while on OOD and OTD , respectively .
RESULTS	Advantages for OOD regarding consistency of analgesia ( i.e. use of rescue medication , current and recalled pain ) and sedation did not reach statistical significance in this limited study population .
CONCLUSIONS	Despite the small number of patients and short study duration , the results support the conclusion that new OOD is ( at least ) equivalent to established OTD regarding safety and efficacy .

###24332392
OBJECTIVE	To investigate factors mediating the effects of a European school-based intervention ( Unplugged ) based on a social influence approach to youths ' substance use .
METHODS	Schools in seven European countries ( n = 143 , including 7,079 pupils ) were randomly assigned to an experimental condition ( Unplugged curriculum ) or a control condition ( usual health education ) .
METHODS	Data were collected before ( pretest ) and 3 months after the end of the program ( posttest ) .
METHODS	Multilevel multiple mediation models were applied to the study of effect mediation separately for tobacco , alcohol , and cannabis use .
METHODS	Analyses were conducted on the whole sample , and separately on baseline users and nonusers of each substance .
RESULTS	Compared with the control group , participants in the program endorsed less positive attitudes toward drugs ; positive beliefs about cigarettes , alcohol , and cannabis ; and the normative perception of peers using tobacco and cannabis .
RESULTS	They also increased in knowledge about all substances and refusal skills toward tobacco .
RESULTS	Decreased positive attitudes toward drugs , increase in refusal skills , and reappraisal of norms about peer using tobacco and cannabis appeared to mediate the effects of the program on the use of substances .
RESULTS	However , mediating effects were generally weak and some of them were only marginally significant .
CONCLUSIONS	This study lends some support to the notion that school-based programs based on a social influence model may prevent juvenile substance use through the modification of attitudes , refusal skills , and normative perceptions .

###24676373
BACKGROUND	Patients with heart failure ( HF ) have left ventricular dysfunction and reduced mean arterial pressure ( MAP ) .
BACKGROUND	Increased adrenergic drive causes vasoconstriction and vessel resistance maintaining MAP , while increasing peripheral vascular resistance and conduit vessel stiffness .
BACKGROUND	Increased pulse pressure ( PP ) reflects a complex interaction of the heart with the arterial and venous systems .
BACKGROUND	Increased PP is an important risk marker in patients with chronic HF ( CHF ) .
BACKGROUND	Non-invasive ventilation ( NIV ) has been used for acute decompensated HF , to improve congestion and ventilation through both respiratory and hemodynamic effects .
BACKGROUND	However , none of these studies have reported the effect of NIV on PP .
OBJECTIVE	The objective of this study was to determine the acute effects of NIV with CPAP on PP in outpatients with CHF .
METHODS	Following a double-blind , randomized , cross-over , and placebo-controlled protocol , twenty three patients with CHF ( 17 males ; 6011 years ; BMI 295 kg/cm2 , NYHA class II , III ) underwent CPAP via nasal mask for 30 min in a recumbent position .
METHODS	Mask pressure was 6 cmH2O , whereas placebo was fixed at 0-1 cmH2O .
METHODS	PP and other non invasive hemodynamics variables were assessed before , during and after placebo and CPAP mode .
RESULTS	CPAP decreased resting heart rate ( Pre : 729 ; vs. Post 5 min : 6710 bpm ; p < 0.01 ) and MAP ( CPAP : 8711 ; vs. control 9611 mmHg ; p < 0.05 post 5 min ) .
RESULTS	CPAP decreased PP ( CPAP : 4720 pre to 3819 mmHg post ; vs. control : 4212 mmHg , pre to 4118 post p < 0.05 post 5 min ) .
CONCLUSIONS	NIV with CPAP decreased pulse pressure in patients with stable CHF .
CONCLUSIONS	Future clinical trials should investigate whether this effect is associated with improved clinical outcome .

###24326281
OBJECTIVE	This study aims to evaluate the role of a decision aid intervention in knowledge of menopausal symptom management .
METHODS	Five hundred fifteen U.S. women who had menopausal symptoms and had discussed symptom management with providers within the past 12 months were assigned to either receive a decision aid or not .
METHODS	Participants completed a telephone survey 2 weeks after enrollment to assess knowledge .
METHODS	Overall knowledge scores and knowledge scores for general symptoms , benefits of hormone therapy , and risks of HT were compared between the decision aid arm and the control arm .
RESULTS	Four hundred one women completed the survey .
RESULTS	Participants in the decision aid arm had a significantly higher mean ( SD ) knowledge score ( 63.3 % [ 18.4 % ] ) compared with the control arm ( 57.5 % [ 16.4 % ] ; P = 0.001 ) .
RESULTS	Specifically , participants in the decision aid arm had significantly higher scores for general symptoms ( mean difference , 11.0 ; 95 % CI , 5.3 to 16.6 ; P < 0.001 ) and knowledge about benefits of HT ( mean difference , 4.2 ; 95 % CI , 0.03 to 8.5 ; P = 0.048 ) compared with the control arm .
RESULTS	However , scores on knowledge about HT risks were not different between the arms ( mean difference , 2.1 ; 95 % CI , -3.0 to 7.2 ; P = 0.422 ) .
CONCLUSIONS	The decision aid arm has greater knowledge of menopausal symptom management compared with the control arm , although the difference is small .
CONCLUSIONS	In general , there is a considerable lack of knowledge about menopausal symptoms and HT risks .

###26031760
OBJECTIVE	To examine the association between odor identification deficits and future mortality in a multiethnic community cohort of older adults .
METHODS	Participants were evaluated with the 40-item University of Pennsylvania Smell Identification Test ( UPSIT ) .
METHODS	Follow-up occurred at 2-year intervals with information on death obtained from informant interviews and the National Death Index .
RESULTS	During follow-up ( mean = 4.1 years , standard deviation = 2.6 ) , 349 of 1,169 ( 29.9 % ) participants died .
RESULTS	Participants who died were more likely to be older ( p < 0.001 ) , be male ( p < 0.001 ) , have lower UPSIT scores ( p < 0.001 ) , and have a diagnosis of dementia ( p < 0.001 ) .
RESULTS	In a Cox model , the association between lower UPSIT score and mortality ( hazard ratio [ HR ] = 1.07 per point interval , 95 % confidence interval [ CI ] = 1.05-1 .08 , p < 0.001 ) persisted after controlling for age , gender , education , ethnicity , language , modified Charlson medical comorbidity index , dementia , depression , alcohol abuse , head injury , smoking , body mass index , and vision and hearing impairment ( HR = 1.05 , 95 % CI = 1.03-1 .07 , p < 0.001 ) .
RESULTS	Compared to the fourth quartile with the highest UPSIT scores , HRs for mortality for the first , second , and third quartiles of UPSIT scores were 3.81 ( 95 % CI = 2.71-5 .34 ) , 1.75 ( 95 % CI = 1.23-2 .50 ) , and 1.58 ( 95 % CI = 1.09-2 .30 ) , respectively .
RESULTS	Participant mortality rate was 45 % in the lowest quartile of UPSIT scores ( anosmia ) and 18 % in the highest quartile of UPSIT scores .
CONCLUSIONS	Impaired odor identification , particularly in the anosmic range , is associated with increased mortality in older adults even after controlling for dementia and medical comorbidity .

###25602633
OBJECTIVE	To compare the efficacy of air and octafluoropropane ( C3F8 ) in treating rhegmatogenous retinal detachments with inferior breaks after 23-gauge pars plana vitrectomy .
METHODS	A prospective , randomized comparative interventional study .
METHODS	Sixty-four patients with rhegmatogenous retinal detachment with inferior breaks underwent pars plana vitrectomy with air ( 32 eyes ) or gas ( 32 eyes ) tamponade .
METHODS	Anatomical and visual outcomes of the two groups were compared .
RESULTS	The mean follow-up period was 13.09 1.90 months .
RESULTS	Significant differences were identified regarding prone positioning period ( P < 0.01 ) , intraocular pressure ( P < 0.01 ) , and gas volume ( P = 0.03 ) on the first postoperative day .
RESULTS	The single-operation success rates for the air and gas groups were 84.38 % and 78.13 % ( P = 0.522 ) , and the final surgery success rates increased to 100 % and 96.88 % ( P = 0.313 ) , respectively .
RESULTS	The single-operation success rate between the groups was not statistically significant , even after adjustment for confounding factors .
RESULTS	Multivariate logistic regression also indicated that the number of involved retinal quadrants ( odds ratio = 19.88 , P = 0.01 ) was an independent predictor of surgery failure .
RESULTS	The only postoperative complication observed was new or missed breaks , which occurred in 12 patients ( 18.75 % ) .
CONCLUSIONS	Air had equivalent tamponade effects to C3F8 , with a shorter prone positioning period , fewer complications , and less expense , in the surgical management of rhegmatogenous retinal detachment with inferior breaks .

###25614397
OBJECTIVE	The purpose of this study was to determine whether sonographic measurement of the inferior vena cava ( IVC ) in college football players during preseason camp is a reliable way to detect and monitor dehydration .
OBJECTIVE	Our primary hypothesis was that IVC diameter measurements , the postpractice caval index , and expiratory diameter were significantly related to percent weight loss after a preseason football practice .
METHODS	A prospective cohort sample of Division I intercollegiate football players in preseason training camp was recruited before practice .
METHODS	All football players on the active roster who were at least 18 years of age were eligible to participate in the study .
METHODS	Sonographic IVC measurements were obtained in the long axis using either the subcostal or subxiphoid approach during inspiration and expiration both before and after an approximately 3-hour practice with moderate to high levels of exertion at high ambient temperatures .
METHODS	Player weights were recorded in the locker room before and after practice .
RESULTS	A total of 27 prepractice and postpractice sonographic measurements were obtained .
RESULTS	The postpractice expiratory IVC diameter was significantly related to percent weight loss after practice ( R ( 2 ) = 0.153 ; P = .042 ) , with the IVC diameter being significantly inversely correlated with percent weight loss ; the regression coefficient was -1.07 ( 95 % confidence interval , -2.09 to -0.04 ) .
RESULTS	There was no statistically significant relationship between percent weight loss and the postpractice caval index ; the regression coefficient was 0.245 ( 95 % confidence interval , -0.10 to 0.59 ; R ( 2 ) = 0.078 ; P = .16 ) .
CONCLUSIONS	The postpractice expiratory IVC diameter was significantly related to percent weight loss after practice , whereas the caval index was not found to correlate with weight loss .

###25837194
OBJECTIVE	We compared three methods of ultrasound-guided axillary brachial plexus block , which were single , and double perivascular ( PV ) infiltration techniques , and a perineural ( PN ) injection technique .
METHODS	78 patients of American Society of Anesthesiologists physical status I-II undergoing surgery of the forearm , wrist , or hand were randomly allocated to three groups .
METHODS	2 % lidocaine with epinephrine 5 g/mL was used .
METHODS	The PN group ( n = 26 ) received injections at the median , ulnar , and radial nerve with 8 mL for each nerve .
METHODS	The PV1 group ( n = 26 ) received a single injection of 24 mL at 12-o'clock position of the axillary artery .
METHODS	The PV2 group ( n = 26 ) received two injections of 12 mL each at 12-o'clock and 6-o'clock position .
METHODS	For all groups , musculocutaneous nerve was blocked separately .
RESULTS	The PN group ( 391.2171.6 sec ) had the longest anesthetic procedure duration than PV1 ( 192.859.0 sec ) and PV2 ( 211.458.6 sec ) .
RESULTS	There were no differences in onset time .
RESULTS	The average induction time was longer in PN group ( 673.4149.6 sec ) than PV1 ( 557.6194.9 sec ) and PV2 ( 561.5129.8 sec ) .
RESULTS	There were no differences in the success rate ( 89.7 % vs. 86.2 % vs. 89.7 % ) .
CONCLUSIONS	The PV injection technique consisting of a single injection in 12-o'clock position above the axillary artery in addition to a musculocutaneous nerve block is equally effective and less time consuming than the PN technique .
CONCLUSIONS	Therefore , the PV technique is an alternative method that may be used in busy clinics or for difficult cases .

###24461109
OBJECTIVE	Pasireotide , a multireceptor-targeted somatostatin analogue with efficacy in Cushing 's disease and acromegaly , can affect glucose metabolism due to inhibition of insulin secretion and incretin hormone responses .
OBJECTIVE	A study was therefore conducted to evaluate different antihyperglycemic drugs in the management of pasireotide-associated hyperglycemia .
METHODS	This was a 1-week , Phase I , open-label study .
METHODS	Healthy male volunteers were randomized to pasireotide 600 g sc bid alone or co-administered with metformin 500 mg po bid , nateglinide 60 mg po tid , vildagliptin 50mg po bid , or liraglutide 0.6 mg sc qd .
METHODS	An oral glucose tolerance test ( OGTT ) was performed on days 1 and 7 to evaluate effects on serum insulin , plasma glucose and glucagon levels .
METHODS	Safety/tolerability and pharmacokinetic effects were also evaluated .
RESULTS	Ninety healthy male volunteers were enrolled ( n = 18 per arm ) .
RESULTS	After 7 days of treatment , plasma glucose AUC post-OGTT increased by 69 % with pasireotide alone .
RESULTS	The effect was reduced by 13 % , 29 % , 45 % and 72 % with co-administration of metformin , nateglinide , vildagliptin and liraglutide , respectively .
RESULTS	On day 7 , compared with pasireotide alone , the decrease in serum insulin was attenuated with nateglinide , metformin , liraglutide and vildagliptin co-administration ( levels were 3 % , 6 % , 34 % and 71 % higher , respectively ) .
RESULTS	Minimal changes in plasma glucagon were observed .
RESULTS	Adverse events were consistent with the safety profiles of the drugs used .
CONCLUSIONS	Vildagliptin and liraglutide were most effective in minimizing pasireotide-associated hyperglycemia in healthy volunteers .

###24486592
OBJECTIVE	Approximately 30 % higher grade premalignant oral intraepithelial neoplasia ( OIN ) lesions will progress to oral cancer .
OBJECTIVE	Although surgery is the OIN treatment mainstay , many OIN lesions recur , which is highly problematic for both surgeons and patients .
OBJECTIVE	This clinical trial assessed the chemopreventive efficacy of a natural product-based bioadhesive gel on OIN lesions .
METHODS	This placebo-controlled multicenter study investigated the effects of topical application of bioadhesive gels that contained either 10 % w/w freeze-dried black raspberries ( BRB ) or an identical formulation devoid of BRB placebo to biopsy-confirmed OIN lesions ( 0.5 g q.i.d. , 12 weeks ) .
METHODS	Baseline evaluative parameters ( size , histologic grade , LOH events ) were comparable in the randomly assigned BRB ( n = 22 ) and placebo ( n = 18 ) gel cohorts .
METHODS	Evaluative parameters were : histologic grade , clinical size , and LOH .
RESULTS	Topical application of the BRB gel to OIN lesions resulted in statistically significant reductions in lesional sizes , histologic grades , and LOH events .
RESULTS	In contrast , placebo gel lesions demonstrated a significant increase in lesional size and no significant effects on histologic grade or LOH events .
RESULTS	Collectively , these data strongly support BRB 's chemopreventive impact .
RESULTS	A cohort of very BRB-responsive patients , as demonstrated by high therapeutic efficacy , was identified .
RESULTS	Corresponding protein profiling studies , which demonstrated higher pretreatment levels of BRB metabolic and keratinocyte differentiation enzymes in BRB-responsive lesions , reinforce the importance of local metabolism and differentiation competency .
CONCLUSIONS	Results from this trial substantiate the LOH reductions identified in the pilot BRB gel study and extend therapeutic effects to significant improvements in histologic grade and lesional size .

###24668204
OBJECTIVE	Unruptured intracranial aneurysm repair is the most commonly performed procedure for the prevention of hemorrhagic stroke .
OBJECTIVE	Despite efforts to regionalize care in high-volume centers , overall results have improved little .
OBJECTIVE	This study aims to determine the effectiveness in improving outcomes of previous efforts to regionalize unruptured intracranial aneurysm repair to high-volume centers and to recommend future steps toward that goal .
METHODS	Using data obtained via the New York Statewide Planning and Research Cooperative System , this study included all patients admitted to any of the 10 highest volume centers in New York state between 2005 and 2010 with a principal diagnosis of unruptured intracranial aneurysm who were treated either by microsurgical or endovascular repair .
METHODS	Mixed-effects logistic regression was used to determine the degree to which hospital-level and patient-level variables contributed to observed variation in good outcome , defined as discharge to home , between hospitals .
RESULTS	Of 3499 patients treated during the study period , 2692 ( 76.9 % ) were treated at the 10 highest volume centers , with 2198 ( 81.6 % ) experiencing a good outcome .
RESULTS	Good outcomes varied widely between centers , with 44.6 % to 91.1 % of clipped patients and 75.4 % to 92.1 % of coiled patients discharged home .
RESULTS	Mixed-effects logistic regression revealed that procedural volume accounts for 85.8 % of the between-hospital variation in outcome .
CONCLUSIONS	There is notable interhospital heterogeneity in outcomes among even the largest volume unruptured intracranial aneurysm referral centers .
CONCLUSIONS	Although further regionalization may be needed , mandatory participation in prospective , adjudicated registries will be necessary to reliably identify factors associated with superior outcomes .

###25884223
BACKGROUND	Addiction constitutes a major public health problem , and despite treatment , relapse rates remain very high .
BACKGROUND	Preliminary findings suggest that Eye Movement Desensitization and Reprocessing ( EMDR ) , an evidence-based treatment for PTSD , may also reduce craving and relapse rates when applied in substance abuse .
BACKGROUND	This study aims to determine the feasibility , efficacy and effectiveness of EMDR when added to treatment as usual ( TAU ) for addiction in alcohol dependent outpatients , compared to TAU only .
METHODS	A single blinded study in which 100 adult patients with a primary DSM-IV-TR diagnosis of alcohol dependence or abuse receiving treatment in one of six Dutch outpatient addiction care facility sites , will be enrolled .
METHODS	After baseline assessment participants will be allocated to one of two treatment conditions ( allocation ratio of 1:1 ) using a stratified ( per site , per care pathway ) , blocked randomization procedure .
METHODS	The intervention consists of EMDR ( seven weekly 90 minute sessions ) + TAU or TAU only .
METHODS	Assessments are scheduled pre-treatment ( t0 ) , post-treatment ( t0 + eight weeks ) , and one and six months post treatment .
METHODS	The effects of both treatment arms are compared on indices of ( a ) drinking behavior , ( b ) mediators , moderators and predictors of treatment outcome , ( c ) quality of life and d ) safety , acceptability and feasibility of treatment .
METHODS	Repeated measures ANOVA 's will be conducted using an intention-to-treat and per-protocol approach .
METHODS	Multiple imputation will be used to deal with missing values when possible .
CONCLUSIONS	This study adapts and extends the standard EMDR treatment for traumatized patients for use with patients with alcohol use disorders without psychological trauma .
BACKGROUND	ClinicalTrial.gov : NCT01828866 .

###24983306
BACKGROUND	Cytomegalovirus ( CMV ) infection involves interaction between endothelial cells and leukocyte subsets that may promote vascular inflammation and lead to treatment failure in infected individuals .
BACKGROUND	Osteoprotegerin is a marker of vascular and systemic inflammation but has not been investigated in relation to treatment outcome during CMV infection .
METHODS	We investigated whether circulating levels of osteoprotegerin are related to features of CMV disease and treatment outcomes during CMV infection in 291 solid organ transplant recipients receiving valganciclovir or ganciclovir in an international multicenter trial of CMV disease treatment ( the VICTOR study ) .
RESULTS	Elevated plasma osteoprotegerin was associated with ( i ) certain disease characteristics including presence of tissue invasive disease ( P < 0.05 ) and increased viral load at baseline ( P < 0.05 ) , ( ii ) poor virological outcome at day 49 after anti-CMV therapy , ( iii ) increased plasma levels of markers of inflammation ( pentraxin 3 and C-reactive protein ) and endothelial cell activation ( von Willebrand factor ) both at baseline and during follow-up .
CONCLUSIONS	Our finding indicates that elevated osteoprotegerin levels in solid organ transplant recipients with CMV infection may reflect vascular inflammation and is associated with late virological outcome in these patients .

###24397244
OBJECTIVE	To compare the efficacy of two mechanical devices for cervical ripening : double versus single balloon catheters , both with extra-amniotic saline infusion ( EASI ) .
METHODS	Women at term with a singleton pregnancy presenting for labor induction were assigned to receive the double balloon catheter ( with EASI ) or the single balloon catheter ( with EASI ) .
METHODS	Outcomes included time from device insertion to delivery , rates of successful vaginal delivery and occurrence of adverse events .
RESULTS	One hundred and eighty-six women completed the study .
RESULTS	Ripening success was comparable between the double and single balloon arms ( 96.4 % versus 92.7 % , p = 0.55 , respectively ) .
RESULTS	Balloon insertion to delivery interval was significantly shorter , and cesarean section rate was significantly lower in the double balloon arm compared with the single balloon arm ( 14.3 versus 15.8 h , p = 0.04 and 8.3 % versus 20 % , p = 0.05 , respectively ) .
RESULTS	There were no significant differences in maternal characteristics , satisfaction or adverse outcomes .
CONCLUSIONS	This study is the first documented assessment of the double balloon catheter combined with EASI .
CONCLUSIONS	Our findings suggest that the double balloon catheter results in reduced time to delivery and higher vaginal delivery rates , compared with the single balloon catheter with EASI , without compromising maternal or fetal safety .

###24512944
OBJECTIVE	Across the United States , tens of thousands of college students are mandated to receive an alcohol intervention following an alcohol policy violation .
OBJECTIVE	Telephone interventions may be an efficient method to provide mandated students with an intervention , especially when they are away from campus during summer vacation .
OBJECTIVE	However , little is known about the utility of telephone-delivered brief motivational interventions .
METHODS	Participants in the study ( N = 57 ) were college students mandated to attend an alcohol program following a campus-based alcohol citation .
METHODS	Participants were randomized to a brief motivational phone intervention ( pBMI ) ( n = 36 ) or assessment only ( n = 21 ) .
METHODS	Ten participants ( 27.8 % ) randomized to the pBMI did not complete the intervention .
METHODS	Follow-up assessments were conducted 3 , 6 , and 9 months post-intervention .
RESULTS	Results indicated the pBMI significantly reduced the number of alcohol-related problems compared to the assessment-only group .
RESULTS	Participants who did not complete the pBMI appeared to be lighter drinkers at baseline and randomization , suggesting the presence of alternate influences on alcohol-related problems .
CONCLUSIONS	Phone BMIs may be an efficient and cost-effective method to reduce harms associated with alcohol use by heavy-drinking mandated students during the summer months .

###24257718
BACKGROUND	Epidemiologic and experimental data have suggested that chlorogenic acid , which is a polyphenol contained in green coffee beans , prevents diet-induced hepatic steatosis and insulin resistance .
OBJECTIVE	We assessed whether the consumption of chlorogenic acid-rich coffee attenuates the effects of short-term fructose overfeeding , dietary conditions known to increase intrahepatocellular lipids ( IHCLs ) , and blood triglyceride concentrations and to decrease hepatic insulin sensitivity in healthy humans .
METHODS	Effects of 3 different coffees were assessed in 10 healthy volunteers in a randomized , controlled , crossover trial .
METHODS	IHCLs , hepatic glucose production ( HGP ) ( by 6,6-d2 glucose dilution ) , and fasting lipid oxidation were measured after 14 d of consumption of caffeinated coffee high in chlorogenic acid ( C-HCA ) , decaffeinated coffee high in chlorogenic acid , or decaffeinated coffee with regular amounts of chlorogenic acid ( D-RCA ) ; during the last 6 d of the study , the weight-maintenance diet of subjects was supplemented with 4 g fructose kg ( -1 ) d ( -1 ) ( total energy intake SD : 143 1 % of weight-maintenance requirements ) .
METHODS	All participants were also studied without coffee supplementation , either with 4 g fructose kg ( -1 ) d ( -1 ) ( high fructose only ) or without high fructose ( control ) .
RESULTS	Compared with the control diet , the high-fructose diet significantly increased IHCLs by 102 36 % and HGP by 16 3 % and decreased fasting lipid oxidation by 100 29 % ( all P < 0.05 ) .
RESULTS	All 3 coffees significantly decreased HGP .
RESULTS	Fasting lipid oxidation increased with C-HCA and D-RCA ( P < 0.05 ) .
RESULTS	None of the 3 coffees significantly altered IHCLs .
CONCLUSIONS	Coffee consumption attenuates hepatic insulin resistance but not the increase of IHCLs induced by fructose overfeeding .
CONCLUSIONS	This effect does not appear to be mediated by differences in the caffeine or chlorogenic acid content .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT00827450 .

###24266733
BACKGROUND	High-sensitivity C-reactive protein ( hsCRP ) is an important biomarker of risk for coronary heart disease morbidity and mortality .
BACKGROUND	We investigated the influence of short-term cardiac rehabilitation ( CR ) after acute myocardial infarction ( AMI ) on values of hsCRP and classical risk factors , including metabolic syndrome .
METHODS	hsCRP and classical risk factors were measured before and after completed 2-week CR program in 30 men after AMI .
METHODS	The comparison group comprised 30 age-balanced healthy men , with no risk factors for coronary heart disease .
RESULTS	As expected , in comparison to healthy individuals , patients had higher values of hsCRP ; furthermore , smokers had significantly higher hsCRP values than nonsmokers .
RESULTS	Patients had more expressed markers of metabolic syndrome and due to pharmacological therapy lower blood pressure , total cholesterol and low-density lipoprotein cholesterol ( LDL-C ) .
RESULTS	After CR was completed , a significant drop in hsCRP ( P = 0.006 ) and improvement of metabolic syndrome parameters ( lower body mass index , blood pressure , LDL-C , triglycerides ) was observed in nonsmokers , whereas no such changes occurred in smokers .
CONCLUSIONS	Our study revealed that hsCRP and metabolic syndrome parameters can be substantially reduced by a 2-week CR program ; however , this effect is present only in nonsmokers .
CONCLUSIONS	Thus , all patients entering the CR program after AMI should be advised to quit smoking before entering the program to achieve optimal benefits .

###25879810
BACKGROUND	Many children do not engage in recommended levels of physical activity ( PA ) , highlighting the need to find ways to increase children 's PA. .
BACKGROUND	Process evaluations play an important role in improving the science of randomised controlled trials .
BACKGROUND	We recently reported the results of the Action 3:30 cluster randomised feasibility trial illustrating higher levels of moderate to vigorous intensity PA among boys but not girls .
BACKGROUND	The aim of this paper is to report the process evaluation results including intervention fidelity , implementation , context and how intervention components and trial design could be improved before proceeding to a definitive RCT .
METHODS	Children 's session enjoyment was assessed every two weeks .
METHODS	Reasons for non-attendance were provided by questionnaire at the end of the intervention .
METHODS	Post intervention interviews were held with participating teaching assistants ( TAs ) and school key contacts ( KCs ) , and focus groups were conducted with children in all 10 intervention schools .
METHODS	Interviews and focus groups examined how recruitment and session attendance might be improved and established which elements of the programme that were and were not well received .
RESULTS	Data indicated good intervention fidelity with TA 's adopting enjoyment-focussed teaching styles and the sessions improving children 's skills and self-esteem .
RESULTS	Several positive aspects of implementation were identified , including high session variety , the opportunity to work in teams , the child-led sessions and the engaging leader style .
RESULTS	In terms of context there was evidence that TA 's faced difficulties managing challenging behaviour and that further training in this area was needed .
RESULTS	TAs and KCs felt that recruitment could be improved by providing taster sessions during PE lessons and clarifying the days that the clubs would run at the point of recruitment .
RESULTS	The programme could be improved to enhance interest for girls , by including training for managing disruptive behaviour and making some activities more age-group appropriate .
CONCLUSIONS	Action 3.30 showed promise but could be improved by ensuring age appropriate activities , providing more appeal to girls and improving recruitment through taster sessions and early establishment of days of the week it is to be offered on .
BACKGROUND	ISRCTN58502739 .

###25588785
BACKGROUND	Increasing evidence suggests obesity has its origins prior to birth .
BACKGROUND	There is clear correlation between maternal obesity , high birthweight and offspring risk of obesity in later life .
BACKGROUND	It is also clear that women who are obese during pregnancy are at greater risk of adverse outcomes , including gestational diabetes and stillbirth .
BACKGROUND	The mechanism ( s ) by which obesity causes these problems is unknown , although hyperglycaemia and insulin resistance are strongly implicated .
BACKGROUND	We present a protocol for a study to test the hypothesis that metformin will improve insulin sensitivity in obese pregnant women , thereby reducing the incidence of high birthweight babies and other pregnancy complications .
METHODS	The Efficacy of Metformin in Pregnant Obese Women , a Randomised controlled ( EMPOWaR ) trial is a double-masked randomised placebo-controlled trial to determine whether metformin given to obese ( body mass index > 30kg/m ( 2 ) ) pregnant women from 16weeks ' gestation until delivery reduces the incidence of high birthweight babies .
METHODS	A secondary aim is to test the mechanism ( s ) of any effect .
METHODS	Obese women with a singleton pregnancy and normal glucose tolerance will be recruited prior to 16weeks ' gestation and prescribed study medication , metformin or placebo , to be taken until delivery .
METHODS	Further study visits will occur at 28 and 36weeks ' gestation for glucose tolerance testing and to record anthropometric measurements .
METHODS	Birth weight and other measurements will be recorded at time of delivery .
METHODS	Anthropometry of mother and baby will be performed at 3months postdelivery .
METHODS	As of January 2014 , 449 women had been randomised across the UK .
BACKGROUND	The study will be conducted in accordance with the principles of Good Clinical Practice .
BACKGROUND	A favourable ethical opinion was obtained from Scotland A Research Ethics Committee , reference number 10/MRE00/12 .
BACKGROUND	Results will be disseminated at conferences and published in peer-reviewed journals .
BACKGROUND	ISRCTN51279843 .

###25513788
BACKGROUND	Dissociation between plasma-free cortisol and total cortisol profiles exists in critical illness .
BACKGROUND	Data on plasma-free cortisol are based on either calculated values or immunoassay-based measurements .
BACKGROUND	Both have significant limitations .
BACKGROUND	Statins have been advocated as a therapy in sepsis .
BACKGROUND	Whether they impact on plasma cortisol through inhibition of cholesterol synthesis is unclear .
OBJECTIVE	In patients enrolled into a randomized trial of statins in sepsis ( n = 250 ) , we examined the association of mass spectrometry measured plasma-free cortisol , plasma-free cortisol/plasma total cortisol ratios , and outcome and the impact of concomitant statin therapy on cortisol profiles in 80 steroid nave patients .
METHODS	Two hundred twenty serial measurements of plasma-free cortisol , plasma total cortisol , and interleukin-6 were collected from 80 patients ( 43 placebo and 37 statins ) .
METHODS	Data from 10 volunteers were used as controls .
RESULTS	Data are presented as median and interquartile range .
RESULTS	Compared with controls , in severe sepsis , baseline plasma total cortisol was elevated two-fold ( 463 nmol/L [ 284-742 nmol/L ] vs 245 nmol/L [ 200-299 nmol/L ] , p < 0.001 ) , plasma-free cortisol 20-fold ( 75 nmol/L [ 20-151 nmol/L ] vs 5 nmol/L [ 5-7 nmol/L ] , p < 0.001 ) , and plasma-free cortisol/plasma total cortisol ratio six-fold ( 0.15 vs 0.02 , p = 0.058 ) .
RESULTS	Baseline interleukin-6 was elevated at 121 pg/mL ( 65-611 pg/mL ) .
RESULTS	In severe sepsis , there were no differences in plasma total cortisol ( p = 0.66 ) , plasma-free cortisol ( p = 0.77 ) , and interleukin-6 ( p = 0.29 ) between statins and placebo groups .
RESULTS	Plasma-free cortisol , plasma total cortisol , and plasma-free cortisol/plasma total cortisol were positively correlated with interleukin-6 ( p = 0.0001 , p < 0.0004 , and p < 0.001 , respectively ) and day 90 mortality ( p = 0.03 , p = 0.03 , and p = 0.058 , respectively ) .
RESULTS	Elevated plasma-free cortisol/plasma total cortisol ratios were associated with increased length of stay ( p = 0.04 ) .
RESULTS	Baseline plasma-free cortisol , plasma total cortisol , and plasma-free cortisol/plasma total cortisol ratios were higher in nonsurvivors as compared with survivors ( 174 nmol/L [ 77-329 nmol/L ] vs 57 nmol/L [ 17-122 nmol/L ] , p = 0.016 ; 890 nmol/L [ 333-1 ,430 nmol/L ] vs 408 nmol/L [ 269-681 nmol/L ] , p = 0.035 ; and 0.19 [ 0.13-0 .29 ] vs 0.14 [ 0.07-0 .20 ] ; p = 0.054 , respectively ) .
CONCLUSIONS	In severe sepsis , plasma-free cortisol increase is 10-fold greater than that of plasma total cortisol .
CONCLUSIONS	Both are similarly associated with inflammatory response and mortality .
CONCLUSIONS	Elevated plasma-free cortisol/plasma total cortisol ratios were associated with increased length of stay .
CONCLUSIONS	Statin therapy does not influence the plasma cortisol profiles in patients with severe sepsis .

###25733653
BACKGROUND	The incidence of nosocomial infections in children in developed countries is still high , ranging from 8 % to 30 % , and standard preventive measures , such as increased hygiene , are not sufficiently efficacious .
BACKGROUND	One of the potential strategies for their prevention is the use of probiotics .
OBJECTIVE	The aim of the study was to investigate the role of Bifidobacterium animalis subsp .
OBJECTIVE	lactis in preventing nosocomial infections in the acute hospital setting .
METHODS	We conducted a randomized , double-blind , placebo-controlled trial in 727 hospitalized children ( aged 1-18 y ) .
METHODS	The children were randomly allocated to receive placebo ( placebo group , n = 365 ) or B. animalis subsp .
METHODS	lactis at a dose of 10 ( 9 ) colony-forming units/d ( intervention group , n = 362 ) once daily for the entire duration of the hospital stay .
METHODS	Nosocomial infections were defined as infections that occurred > 48 h after hospital admission and that were not present or incubating at the time of admission .
RESULTS	Analysis was performed on an intention-to-treat basis .
RESULTS	There was no difference in the study primary outcome or incidence of common nosocomial gastrointestinal and respiratory tract infections between groups ( 22 vs. 29 infections , respectively ; incidence rate ratio = 0.76 ; 95 % CI : 0.41 , 1.36 ; P = 0.32 ) .
RESULTS	No difference was found for the duration of common nosocomial infections [ mean ( range ) : 3.58 ( 1-7 ) vs. 3.79 ( 1-8 ) d , in placebo vs. intervention group ; P = 0.74 ] .
RESULTS	There was also no difference between the intervention and placebo groups for any of the other secondary outcomes ( incidence of gastrointestinal and respiratory tract infections separately , duration of gastrointestinal and respiratory infections , and duration of hospitalization ) and exploratory outcomes ( gastrointestinal and respiratory symptoms , severity of gastrointestinal and respiratory tract infections , and the use of antibiotics ) .
CONCLUSIONS	The results of this study show that the use of B. animalis subsp .
CONCLUSIONS	lactis failed to prevent nosocomial infections in an acute-setting pediatric hospital in children who were > 1 y of age .
CONCLUSIONS	However , it should be taken into account that the overall incidence of nosocomial infections was lower than expected .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01702766 .

###25691681
BACKGROUND	Hyperphosphatemia necessitates the use of phosphate binders in most dialysis patients .
BACKGROUND	Long-term efficacy and tolerability of the iron-based phosphate binder , sucroferric oxyhydroxide ( previously known as PA21 ) , was compared with that of sevelamer carbonate ( sevelamer ) in an open-label Phase III extension study .
METHODS	In the initial Phase III study , hemo - or peritoneal dialysis patients with hyperphosphatemia were randomized 2:1 to receive sucroferric oxyhydroxide 1.0-3 .0 g/day ( 2-6 tablets/day ; n = 710 ) or sevelamer 2.4-14 .4 g/day ( 3-18 tablets/day ; n = 349 ) for 24 weeks .
METHODS	Eligible patients could enter the 28-week extension study , continuing the same treatment and dose they were receiving at the end of the initial study .
RESULTS	Overall , 644 patients were available for efficacy analysis ( n = 384 sucroferric oxyhydroxide ; n = 260 sevelamer ) .
RESULTS	Serum phosphorus concentrations were maintained during the extension study .
RESULTS	Mean standard deviation ( SD ) change in serum phosphorus concentrations from extension study baseline to Week 52 end point was 0.02 0.52 mmol/L with sucroferric oxyhydroxide and 0.09 0.58 mmol/L with sevelamer .
RESULTS	Mean serum phosphorus concentrations remained within Kidney Disease Outcomes Quality Initiative target range ( 1.13-1 .78 mmol/L ) for both treatment groups .
RESULTS	Mean ( SD ) daily tablet number over the 28-week extension study was lower for sucroferric oxyhydroxide ( 4.0 1.5 ) versus sevelamer ( 10.1 6.6 ) .
RESULTS	Patient adherence was 86.2 % with sucroferric oxyhydroxide versus 76.9 % with sevelamer .
RESULTS	Mean serum ferritin concentrations increased over the extension study in both treatment groups , but transferrin saturation ( TSAT ) , iron and hemoglobin concentrations were generally stable .
RESULTS	Gastrointestinal-related adverse events were similar and occurred early with both treatments , but decreased over time .
CONCLUSIONS	The serum phosphorus-lowering effect of sucroferric oxyhydroxide was maintained over 1 year and associated with a lower pill burden , compared with sevelamer .
CONCLUSIONS	Sucroferric oxyhydroxide was generally well tolerated long-term and there was no evidence of iron accumulation .

###24556276
BACKGROUND	Previous studies have already substantiated alcohol 's causal role in injuries .
BACKGROUND	Yet the role that alcoholic beverage preferences and the drinking context play in the risk for injury is still under-investigated .
BACKGROUND	In this study , a cross-national comparison of the association between alcohol and injury focusing on beverage type preference and the drinking context is reported .
METHODS	Emergency department ( ED ) injured patients were interviewed in eight countries from the Latin American and Caribbean ( LAC ) region .
METHODS	Data on the type of alcoholic beverage , total alcohol volume , and the place where the injury occurred were obtained from patients who reported any alcohol consumption within 6h prior to being injured .
METHODS	Patients who did not drink prior to injury were also asked about their typical drinking pattern and the injury place .
METHODS	Differences within - and between-groups were evaluated regarding patients ' typical drinking and drinking before injury .
RESULTS	Beer was the most prevalent beverage type usually consumed among injured patients across countries , however , patients who drank before injury had a higher typical consumption of spirits than those not drinking prior to injury .
RESULTS	The total alcohol volume typically consumed and drinking in public settings were also found to be positively associated with alcohol-related injury .
CONCLUSIONS	A similar beverage-specific association with alcohol-related injury was found across LAC countries , mainly attributed to beer consumption , and spirits drinkers seem to have a greater chance of becoming involved in injury events .
CONCLUSIONS	Future prevention strategies should inform the public about harms from drinking associated with the context in which drinking takes place .

###25115871
BACKGROUND	Seasonal influenza causes > 200 000 annual hospitalizations in the United States .
BACKGROUND	Current antiviral treatment options are limited to oral or inhaled agents .
BACKGROUND	There is an urgent unmet need for intravenous antiviral treatments .
METHODS	Patients hospitalized with suspected influenza were randomized to 5-day treatment with intravenous peramivir ( 600 mg once daily ) or placebo ; all received the institution 's standard of care ( SOC ) treatment .
METHODS	Time to clinical resolution and change in viral shedding in nasopharyngeal specimens were the primary and key secondary end points .
RESULTS	Influenza infection was confirmed in 338 of 405 enrolled patients .
RESULTS	At the time of a preplanned interim analysis , the primary efficacy analysis population comprised 121 patients who did not receive a concurrent neuraminidase inhibitor as part of the SOC .
RESULTS	The median ( 95 % confidence interval ) time to clinical resolution was 42.5 ( 34.0-57 .9 ) hours for peramivir versus 49.5 ( 40.0-61 .9 ) hours for placebo ( P = .97 ) .
RESULTS	A larger treatment effect was observed in patients with history of symptoms < 48 hours or admitted to an intensive care unit .
RESULTS	Greater reductions in viral shedding , based on median tissue culture infective dose , were observed in patients who received peramivir than in placebo recipients , although this difference was not statistically significant .
RESULTS	The incidence and severity of adverse events and laboratory abnormalities were similar between the 2 treatment groups .
RESULTS	The study was terminated for futility after a preplanned interim analysis .
CONCLUSIONS	A significant clinical benefit was not demonstrated for peramivir plus SOC compared with placebo plus SOC .
CONCLUSIONS	Peramivir was generally safe and well tolerated .
CONCLUSIONS	These findings highlight the challenges in designing studies to evaluate influenza antiviral agents in a hospitalized setting .
CONCLUSIONS	Clinical Trials Registration.NCT00958776 .

###24838085
OBJECTIVE	The authors of this randomized study had for aim to evaluate the impact of training on proper glove use by comparing compliance to glove use recommendations between trained and untrained healthcare personnel according to healthcare professional groups .
METHODS	A random selection of trained and untrained nurses , nurse aids , and hospital housekeepers was performed in a French University hospital , using a listing of healthcare personnel .
METHODS	The audits were conducted by two infection control nurses , in series of 10 observations , with a maximum time limit of two hours .
METHODS	The evaluation criteria were compliance or non-compliance of glove-wearing practices with internal hospital recommendations , disclosed to professionals during training .
RESULTS	Overall , 111 professionals were audited and 794 acts were observed .
RESULTS	Hand hygiene was significantly better in trained vs. untrained healthcare professionals ( P < 0.01 ) .
RESULTS	Proper glove use practices were similar between trained and untrained nurses ( 85 % of compliance ) , whereas the difference was statistically significant in favor of trained healthcare personnel for the other categories ( P < 0.001 for nurse aids and P = 0.02 for housekeepers ) .
CONCLUSIONS	We demonstrated the impact of pluridisciplinary training on proper glove use practices in hospital settings , but with different benefits found according to professional groups .
CONCLUSIONS	The lower the initial training level , the greater the overall benefit appeared to be .

###25498777
OBJECTIVE	To assess the reliability and validity of scores derived from the Patient Perception of Intensity of Urgency Scale ( PPIUS ) in patients with lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) .
METHODS	A post hoc analysis of the phase II Solifenacin and Tamsulosin in Males with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia trial ( NCT00510406 ) , a 12-week clinical trial in men with LUTS associated with BPH , assessed the measurement properties of six PPIUS-derived scores : mean score ; maximum urgency score ; total urgency and frequency score ( TUFS ; average sum of urgency scores over 3 days ) ; and numbers of urgency episodes , urgency episodes of grade 3 or 4 , and urgency incontinence episodes .
METHODS	Test-retest reliability , presence of floor/ceiling effects , responsiveness to change , known-group validity , and concurrent validity were assessed for each score .
RESULTS	A total of 901 patients had at least one valid PPIUS assessment after baseline .
RESULTS	TUFS demonstrated good test-retest reliability ( intraclass correlation coefficient > 0.8 ) , discriminated between groups defined based on International Prostate Symptom Score storage score severity ( known-groups validity ) , had high concurrent validity , and had high responsiveness to change ( Guyatt 's responsiveness statistic 0.88 ) , with an absence of floor or ceiling effects .
RESULTS	The psychometric properties of other PPIUS-derived scores were not as consistently robust and showed either low-to-moderate responsiveness , presence of a floor or ceiling effect , or low-to-moderate test-retest reliability .
CONCLUSIONS	This study shows that the PPIUS is reliable and valid in patients with LUTS associated with BPH .
CONCLUSIONS	TUFS provided the best combination of psychometric properties of the six scores derived from the PPIUS and appeared to be an appropriate measure of urgency and frequency .

###26067687
BACKGROUND	In preclinical work and retrospective population studies , the anti-diabetic drug metformin has been associated with antineoplastic activity and decreased burden of many cancers , including pancreatic cancer .
BACKGROUND	There is therefore interest in the hypothesis that this drug might be repurposed for indications in oncology .
BACKGROUND	We aimed to assess the efficacy of the addition of metformin to a standard systemic therapy in patients with advanced pancreatic cancer , and provide the first report of a clinical trial with a survival endpoint of metformin for an oncological indication .
METHODS	We did this double-blind , randomised , placebo-controlled phase 2 trial at four centres in the Netherlands .
METHODS	Patients aged 18 years or older with advanced pancreatic cancer were randomly assigned ( 1:1 ) , via a permutated computer-generated block allocation scheme ( block size of six ) to receive intravenous gemcitabine ( 1000 mg/m ( 2 ) ) on days 1 , 8 , and 15 every 4 weeks and oral erlotinib ( 100mg ) once daily in combination with either oral metformin or placebo twice daily .
METHODS	Metformin dose was escalated from 500 mg ( in the first week ) to 1000 mg twice daily in the second week .
METHODS	Randomisation was stratified by hospital , diabetes status , and tumour stage .
METHODS	The primary endpoint was overall survival at 6 months in the intention-to-treat population .
METHODS	This trial is complete and is registered with ClinicalTrials.gov , number NCT01210911 .
RESULTS	Between May 31 , 2010 , and Jan 3 , 2014 , we randomly assigned 121 patients to receive gemcitabine and erlotinib with either placebo ( n = 61 ) or metformin ( n = 60 ) .
RESULTS	Overall survival at 6 months was 639 % ( 95 % CI 519-759 ) in the placebo group and 567 % ( 441-692 ) in the metformin group ( p = 041 ) .
RESULTS	There was no difference in overall survival between groups ( median 76 months [ 95 % CI 61-91 ] vs 68 months [ 95 % CI 51-85 ] in the metformin group ; hazard ratio [ HR ] 1056 [ 95 % CI 072-155 ] ; log-rank p = 078 ) .
RESULTS	The most frequent grade 3-4 toxic effects were neutropenia ( 15 [ 25 % ] patients in placebo group vs 15 [ 25 % ] in metformin group ) , skin rash ( six [ 10 % ] vs four [ 7 % ] ) , diarrhoea ( three [ 5 % ] vs six [ 10 % ] ) , and fatigue ( two [ 3 % ] vs six [ 10 % ] ) .
CONCLUSIONS	Addition of a conventional anti-diabetic dose of metformin does not improve outcome in patients with advanced pancreatic cancer treated with gemcitabine and erlotinib .
CONCLUSIONS	Future research should include studies of more potent biguanides , and should focus on patients with hyperinsulinaemia and patients with tumours showing markers of sensitivity to energetic stress , such as loss of function of AMP kinase , a key regulator of cellular energy homoeostasis .
BACKGROUND	Academic Medical Centre , Amsterdam , and The Terry Fox Foundation , Vancouver , Canada .

###24680572
BACKGROUND	Prosthetic repair has become the standard method for hernia repair .
BACKGROUND	Mesh placement for the prevention of trocar site incisional hernia ( TSIH ) is still a controversial issue .
BACKGROUND	We tested the hypothesis that closure with an intraperitoneal prophylactic mesh of the umbilical trocar after a laparoscopic cholecystectomy can reduce the incidence of a TSIH in high-risk patients .
METHODS	A randomized clinical trial was conducted among patients undergoing elective laparoscopic cholecystectomy who presented the following high-risk factors for incisional hernia , according to the literature : age 65 years and older , diabetes mellitus , chronic pulmonary disease , and obesity ( ie , body mass index 30 kg/m ( 2 ) ) .
METHODS	Patients were assigned to have closure of the umbilical trocar site with either nonabsorbable sutures ( group A ) or intraperitoneal polypropylene omega-3 mesh ( group B ) .
METHODS	Trocar site incisional hernia , pain , and surgical complications were evaluated at the early postoperative course and at 1 , 6 , and 12 months after surgery .
RESULTS	A total of 106 patients were randomized into the study and 92 patients were finally analyzed , including 47 in group A and 45 in group B.
RESULTS	The TSIH rate was higher in group A ( 31.9 % ) than in group B ( 4.4 % ) ( odds ratio = 10.1 ; 95 % CI , 2.15-47 .6 ; p < 0.001 ) ) .
RESULTS	The wound infection rate was 4.3 % ; 8.5 % in group A and 0 % in group B ( odds ratio = 2.04 ; 95 % CI , 1.7-2 .5 ; p = 0.045 ) .
RESULTS	Median postoperative pain evaluated by a visual analogue scale was 3 in group A and 2 in group B ( p = 0.05 ) .
RESULTS	No differences were observed in complication rate , operative time , or hospital stay between the groups .
CONCLUSIONS	Prosthetic closure of the umbilical trocar site after laparoscopic surgery could become the standard method for preventing TSIH in high-risk patients .

###24296323
BACKGROUND	Etamicastat is a dopamine - hydroxylase ( DH ) inhibitor currently in clinical development for the treatment of hypertension and heart failure .
OBJECTIVE	This study assessed the tolerability , pharmacokinetics , and pharmacodynamics of etamicastat in patients with arterial hypertension .
METHODS	This randomized , double-blind , placebo-controlled study was conducted in male patients aged between 18 and 65 years with mild to moderate hypertension .
METHODS	Participants received once-daily doses of etamicastat 50 , 100 , or 200 mg or placebo for 10 days .
METHODS	Antihypertensive effect was assessed by 24-hour ambulatory blood pressure monitoring ( ABPM ) .
RESULTS	The study enrolled 23 male volunteers , with ages between 49 and 64 years .
RESULTS	There were no serious adverse events reported .
RESULTS	All adverse events were mild to moderate in intensity and resolved without sequelae .
RESULTS	Etamicastat Tmax was 1 hour postdose , and mean t was 19 to 28 hours following repeated administration .
RESULTS	Etamicastat underwent N-acetylation by N-acetyltransferase 2 ( NAT2 ) , forming the metabolite BIA 5-961 .
RESULTS	Following repeated administration , mean etamicastat AUC was 2 - to 3-fold greater in poor acetylators than in rapid acetylators .
RESULTS	Approximately 50 % of the etamicastat dose was recovered in urine-30 % as unchanged etamicastat and 20 % as BIA 5-961 .
RESULTS	Dose-dependent decreases in systolic and diastolic blood pressure were observed after 10 days of treatment .
RESULTS	The mean ( 95 % CI ) decreases versus placebo in nighttime SBP were statistically significant with all 3 etamicastat doses ( 50 mg , -11.66 mm Hg [ -21.57 to -1.76 ; P < 0.05 ] ; 100 mg , -14.92 mm Hg [ -24.98 to -4.87 ; P < 0.01 ] ; and 200 mg , -13.62 mm Hg [ -22.29 to -3.95 ; P < 0.01 ] ) .
CONCLUSIONS	Etamicastat was well tolerated and showed a pharmacokinetic profile consistent with a once-daily regimen .
CONCLUSIONS	NAT2 phenotype markedly affected the pharmacokinetics .
CONCLUSIONS	The antihypertensive effect of etamicastat , assessed by 24-hour ABPM , was dose dependent up to 100 mg .
CONCLUSIONS	The assessment of etamicastat as a novel antihypertensive therapy requires further study in broader populations .
CONCLUSIONS	EudraCT trial registration 2008-002789-09 .

###24835901
OBJECTIVE	This study aims to assess possible wound complications of tympanoplasty and tympanomastoidectomy with or without postoperative mastoid dressing .
METHODS	A total of 37 patients ( 22 females , 15 males ; mean age : 23.88 years ; range 9 to 64 years ) who underwent middle ear or mastoid operations via postauricular incision were included in this prospective , randomized , controlled study .
METHODS	The patients were divided into two groups as having mastoid dressing ( n = 17 ) and nonmastoid dressing ( n = 20 ) .
METHODS	Through a close follow-up , postoperative complications were noted and distance from mastoid scalp and auricular rim was measured .
RESULTS	The mean mastoid-helix distance of non-mastoid dressing group was found 17.2 mm in operated and 16.9 mm in non-operated ears .
RESULTS	The mean mastoid-helix distance of mastoid dressing group was 15.53 mm in operated ears and 16.47 mm in non-operated ears .
RESULTS	Skin erythema was seen in a patient .
RESULTS	There was no statistically significant increase in mastoid-helix distance ( p > 0.05 ) .
CONCLUSIONS	Tympanoplasty with or without mastoidectomy does not cause postoperative complication or protrusion of the ear , even if no mastoid dressing is used .
CONCLUSIONS	Our study results suggest no benefit of mastoid dressing after tympanoplasty with or without mastoidectomy .

###24829053
OBJECTIVE	This randomized clinical trial evaluates interscalene brachial plexus block ( ISB ) , general anaesthesia ( GA ) and the combination of both anaesthetic methods ( GA + ISB ) in patients undergoing shoulder arthroscopy .
METHODS	From July 2011 until May 2012 , 120 patients ( male/female ) , aged 20-80 years , were allocated randomly to receive ISB ( 10 ml mepivacaine 1 % and 20 ml ropivacaine 0.375 % ) , GA ( propofol , sunfentanil , desflurane ) or ISB + GA. .
METHODS	The primary outcome variable was opioid consumption at the day of surgery .
METHODS	Anaesthesia times were analysed as secondary endpoints .
RESULTS	After surgery , 27 of 40 patients with a single ISB bypassed the recovery room ( p < 0.0001 ) .
RESULTS	Postoperative monitoring time was significantly shorter with single ISB compared with both other groups [ GA : 93 ( 5-182 ) min vs. GA + ISB : 57.5 ( 11-220 ) min vs. ISB : 35 ( 5-106 ) min , p < 0.0001 ] .
RESULTS	Opioid consumption was reduced using a single ISB at the day of surgery [ GA : n = 25 vs. GA + ISB : n = 10 vs. ISB : n = 10 , p = 0.0037 ] .
CONCLUSIONS	ISB is superior to GA and GA + ISB in patients undergoing shoulder arthroscopy in terms of faster recovery and analgesics consumption .

###24332514
BACKGROUND	Bisphosphonates are routinely used in the treatment of metastatic bone disease from breast cancer to reduce pain and bone destruction .
BACKGROUND	Zoledronic acid given by intravenous infusion has been widely used , but places a substantial logistical burden on both patient and hospital .
BACKGROUND	As a result , the use of oral ibandronic acid has increased , despite the absence of comparative data .
BACKGROUND	In the ZICE trial , we compared oral ibandronic acid with intravenous zoledronic acid for the treatment of metastatic breast cancer to bone .
METHODS	This phase 3 , open-label , parallel group active-controlled , multicentre , randomised , non-inferiority phase 3 study was done in 99 UK hospitals .
METHODS	Eligibility criteria included at least one radiologically confirmed bone metastasis from a histologically confirmed breast cancer .
METHODS	Patients with ECOG performance status 0 to 2 and clinical decision to treat with bisphosphonates within 3 months of randomisation were randomly assigned to receive 96 weeks of treatment with either intravenous zoledronic acid at 4 mg every 3-4 weeks or oral ibandronic acid 50 mg daily .
METHODS	Randomisation ( 1:1 ) was done via a central computerised system within stratified block sizes of four .
METHODS	Randomisation was stratified on whether patients had current or planned treatment with chemotherapy ; current or planned treatment with hormone therapy ; and whether they had a previous skeletal-related event within the last 3 months or had planned radiotherapy treatment to the bone or planned orthopaedic surgery due to bone metastases .
METHODS	The primary non-inferiority endpoint was the frequency and timing of skeletal-related events over 96 weeks , analysed using a per-protocol analysis .
METHODS	All active ( non-withdrawn ) patients have now reached the 96-week timepoint and the trial is now in long-term follow-up .
METHODS	The trial is registered with ClinicalTrials.gov , number NCT00326820 .
RESULTS	Between Jan 13 , 2006 , and Oct 4 , 2010 , 705 patients were randomly assigned to receive ibandronic acid and 699 to receive zoledronic acid ; three patients withdrew immediately after randomisation .
RESULTS	The per-protocol analysis included 654 patients in the ibandronic acid group and 672 in the zoledronic acid group .
RESULTS	Annual rates of skeletal-related events were 0499 ( 95 % CI 0454-0549 ) with ibandronic acid and 0435 ( 0393-0480 ) with zoledronic acid ; the rate ratio for skeletal-related events was 1148 ( 95 % CI 0967-1362 ) .
RESULTS	The upper CI was greater than the margin of non-inferiority of 108 ; therefore , we could not reject the null hypothesis that ibandronic acid was inferior to zoledronic acid .
RESULTS	More patients in the zoledronic acid group had renal toxic effects than in the ibandronic acid group ( 226 [ 32 % ] of 697 vs 172 [ 24 % ] of 704 ) but rates of osteonecrosis of the jaw were low in both groups ( nine [ 1 % ] of 697 vs five [ < 1 % ] of 704 ) .
RESULTS	The most common grade 3 or 4 adverse events were fatigue ( 97 [ 14 % ] of 697 patients allocated zoledronic acid vs 98 [ 14 % ] of 704 allocated ibandronic acid ) , increased bone pain ( 91 [ corrected ] [ 13 % ] vs 85 [ corrected ] [ 12 % ] ) , joint pain ( 41 [ corrected ] [ 6 % ] vs 38 [ 5 % ] ) , infection ( 31 [ 5 % ] vs 23 [ corrected ] [ 3 % ] ) , and nausea or vomiting ( 38 [ 5 % ] vs 41 [ 6 % ] ) .
CONCLUSIONS	Our results suggest that zoledronic acid is preferable to ibandronic acid in preventing skeletal-related events caused by bone metastases .
CONCLUSIONS	However , both drugs have acceptable side-effect profiles and the oral formulation is more convenient , and could still be considered if the patient has a strong preference or if difficulties occur with intravenous infusions .
BACKGROUND	Roche Products Ltd ( educational grant ) , supported by National Institute for Health Research Cancer Network , following endorsement by Cancer Research UK ( CRUKE/04/022 ) .

###24366495
OBJECTIVE	To determine bispectral index ( BIS ) values produced by equipotent concentrations of commonly used volatile anaesthetics .
METHODS	Female patients undergoing thyroidectomy were randomly assigned to receive isoflurane , sevoflurane or desflurane anaesthesia .
METHODS	After induction , anaesthesia was maintained by the volatile agent at 1 minimum alveolar concentration and supplemented with remifentanil infusion .
METHODS	BIS values were recorded during 1h surgical anaesthesia after a 15min equilibrium phase .
RESULTS	Time-averaged BIS value during the study period was significantly lower in the desflurane group ( n = 29 ) than the sevoflurane group ( n = 27 ) ( 37.04.9 vs 41.55.9 ) .
RESULTS	Duration of deep hypnosis ( BIS < 40 ) was significantly longer in the desflurane group than the sevoflurane group ( 40.220.7 vs 24.322.5 min ) .
RESULTS	There were no significant differences in any parameter between the isoflurane group ( n = 27 ) and any other group .
CONCLUSIONS	Desflurane produces a greater hypnotic effect than sevoflurane during equipotent anaesthesia .
CONCLUSIONS	Management of volatile anaesthesia using predetermined minimum alveolar concentration targets can lead to an unnecessarily long duration of deep hypnosis .

###24977401
OBJECTIVE	Diagnostic esophagogastroduodenoscopy ( EGD ) is uncomfortable for most patients .
OBJECTIVE	We determined the efficacy of alprazolam , administered orally or sublingually , as premedication for sedation during EGD .
METHODS	Adult EGD candidates were randomly allocated to four groups ( n = 55 , each group ) and received alprazolam ( 0.5 mg ) sublingually or orally , placebo sublingually or orally at 30 minutes before EGD .
METHODS	Main outcome measures included procedure-related anxiety and pain/discomfort ( assessed using 11-point numeric scales ) , patient overall tolerance ( assessed using a 4-point Likert scale ) , need for intravenous sedation , and willingness to repeat the EGD if necessary .
RESULTS	Patients experienced greater reduction in anxiety score after medication with sublingual alprazolam ( mean 2.25 , standard deviation [ SD ] 1.73 ) compared with sublingual placebo ( mean 0.10 , standard error [ SE ] 0.15 ] ; P < 0.001 ) and oral alprazolam ( 0.63 , SE 0.14 ; P < 0.001 ) .
RESULTS	Also , pain/discomfort scores were lower with sublingual alprazolam compared with sublingual placebo ( 3.29 , SE 0.29 vs. 4.16 , SD 1.86 ; P = 0.024 ) , and with oral alprazolam compared with oral placebo ( 3.48 , SD 1.69 vs. 5.13 , SD 2.39 ; P < 0.001 ) .
RESULTS	Patient overall tolerance was better with sublingual alprazolam than with sublingual placebo ( P = 0.005 ) or with oral alprazolam ( P = 0.009 ) .
RESULTS	Regarding intravenous sedation , there was no difference between sublingual alprazolam and sublingual placebo ( 10.9 % vs. 10.9 % ; P = 0.619 ) or between oral alprazolam and oral placebo ( 9.0 % vs. 12.7 % ; P = 0.381 ) .
RESULTS	Willingness to repeat the procedure was greater with sublingual alprazolam than with sublingual placebo ( 50.9 % vs. 30.9 % ; P = 0.026 ) .
CONCLUSIONS	Sublingual alprazolam is an effective premedication for sedation during EGD .
CONCLUSIONS	It reduces anxiety and pain/discomfort related to EGD and increases patient tolerance and willingness to repeat the EGD if necessary .
BACKGROUND	NCT01949038 ClinicalTrials.gov .

###24803381
BACKGROUND	Drug users ( DUs ) , a population that accounts for some of the fastest-growing human immunodeficiency virus ( HIV ) epidemics globally , lag behind other populations with regard to HIV-related outcomes .
BACKGROUND	We evaluated the role of voucher incentives on linkage and retention in care among DUs in India .
METHODS	In this randomized clinical trial , 120 DUs who were aged 18 years , HIV-infected , antiretroviral therapy ( ART ) naive , and ART eligible and who reported drug use in the prior month were randomized to incentive ( INC ) or control ( CTL ) conditions for 12 months .
METHODS	Participants randomized to the INC arm received incentives ( redeemable for food/household goods ) ranging in value from USD4 to USD8 for achieving prespecified targets ( eg , ART initiation , visits to ART center ) .
METHODS	Subjects in the CTL group could win vouchers in prize-bowl drawings , but HIV care behaviors were not incentivized .
METHODS	The primary endpoint was time to ART initiation .
RESULTS	Sixty participants each were randomized to the INC and CTL arms between December 2009 and September 2010 .
RESULTS	Participants in the INC arm were more likely to visit the government ART center ( 49 vs 33 ; P = .002 ) ; 27 participants in the INC and 16 participants in the CTL arm initiated ART ( P = .04 ; hazard ratio for ART = 2.33 [ 95 % confidence interval , 1.15-4 .73 ] ) .
RESULTS	Participants in the INC arm also had significantly more visits to the ART center ( median number of visits , 8 vs 3.5 ; P = .005 ) .
RESULTS	However , no difference in viral suppression was observed .
CONCLUSIONS	Modest voucher incentives improved linkage to and retention in HIV care , but did not significantly impact viral suppression among DUs in India , a disenfranchised and difficult-to-treat population .
BACKGROUND	NCT01031745 .

###24815497
BACKGROUND	Obstructive sleep apnea ( OSA ) is associated with increased risk of cardiovascular and cerebrovascular disease resulting from intermittent hypoxia ( IH ) - induced inflammation .
BACKGROUND	Cyclooxygenase ( COX ) - formed prostanoids mediate the inflammatory response , and regulate blood pressure and cerebral blood flow ( CBF ) , but their role in blood pressure and CBF responses to IH is unknown .
BACKGROUND	Therefore , this study 's objective was to determine the role of prostanoids in cardiovascular and cerebrovascular responses to IH .
RESULTS	Twelve healthy , male participants underwent three , 6-hour IH exposures .
RESULTS	For 4 days before each IH exposure , participants ingested a placebo , indomethacin ( nonselective COX inhibitor ) , or Celebrex ( ) ( selective COX-2 inhibitor ) in a double-blind , randomized , crossover study design .
RESULTS	Pre - and post-IH blood pressure , CBF , and urinary prostanoids were assessed .
RESULTS	Additionally , blood pressure and urinary prostanoids were assessed in newly diagnosed , untreated OSA patients ( n = 33 ) .
RESULTS	Nonselective COX inhibition increased pre-IH blood pressure ( P 0.04 ) and decreased pre-IH CBF ( P = 0.04 ) while neither physiological variable was affected by COX-2 inhibition ( P 0.90 ) .
RESULTS	Post-IH , MAP was elevated ( P 0.05 ) and CBF was unchanged with placebo and nonselective COX inhibition .
RESULTS	Selective COX-2 inhibition abrogated the IH-induced MAP increase ( P = 0.19 ) , but resulted in lower post-IH CBF ( P = 0.01 ) .
RESULTS	Prostanoids were unaffected by IH , except prostaglandin E2 was elevated with the placebo ( P = 0.02 ) .
RESULTS	Finally , OSA patients had elevated blood pressure ( P 0.4 ) and COX-1 formed thromboxane A2 concentrations ( P = 0.02 ) .
CONCLUSIONS	COX-2 and COX-1 have divergent roles in modulating vascular responses to acute and chronic IH .
CONCLUSIONS	Moreover , COX-1 inhibition may mitigate cardiovascular and cerebrovascular morbidity in OSA .
BACKGROUND	www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01280006 .

###24347430
BACKGROUND	The prognostic and predictive value of the proliferation marker Ki-67 was investigated in a randomized trial comparing accelerated radiotherapy with carbogen breathing and nicotinamide ( ARCON ) to accelerated radiotherapy in laryngeal carcinoma .
METHODS	Labeling index of Ki-67 ( Li Ki-67 ) in immunohistochemically stained biopsies and the colocalization with carbonic anhydrase IX ( CAIX ) were related to tumor control and patient survival .
RESULTS	On average , node-positive patients had a higher Li Ki-67 ( median 14 % vs 8 % ; p < .01 ) .
RESULTS	In patients with a high Li Ki-67 , the 5-year regional control and metastases-free survival were 79 % versus 96 % ( p < .01 ) and 71 % versus 88 % ( p = .05 ) for accelerated radiotherapy and ARCON , respectively .
RESULTS	The 5-year local control and disease-specific survival were not significantly different .
RESULTS	Patients with low Ki-67 expression had an excellent outcome with accelerated radiotherapy alone .
CONCLUSIONS	Patients with laryngeal carcinomas with high proliferative activity are at increased risk of regional and distant metastases formation .
CONCLUSIONS	This risk can be reduced by treatment with ARCON .

###24762560
BACKGROUND	Assessment and discussion of individual risk for breast cancer within the primary care setting are crucial to discussion of risk reduction and timely referral .
METHODS	We conducted a randomized controlled trial of a multiethnic , multilingual sample of women ages 40 to 74 years from two primary care practices ( one academic , one safety net ) to test a breast cancer risk assessment and education intervention .
METHODS	Patients were randomly assigned to control or intervention group .
METHODS	All patients completed a baseline telephone survey and risk assessment ( via telephone for controls , via tablet computer in clinic waiting room before visit for intervention ) .
METHODS	Intervention ( BreastCARE ) patients and their physicians received an individualized risk report to discuss during the visit .
METHODS	One-week follow-up telephone surveys with all patients assessed patient-physician discussion of family cancer history , personal breast cancer risk , high-risk clinics , and genetic counseling/testing .
RESULTS	A total of 655 control and 580 intervention women completed the risk assessment and follow-up interview ; 25 % were high-risk by family history , Gail , or Breast Cancer Surveillance Consortium risk models .
RESULTS	BreastCARE increased discussions of family cancer history [ OR , 1.54 ; 95 % confidence interval ( CI ) , 1.25-1 .91 ] , personal breast cancer risk ( OR , 4.15 ; 95 % CI , 3.02-5 .70 ) , high-risk clinics ( OR , 3.84 ; 95 % CI , 2.13-6 .95 ) , and genetic counseling/testing ( OR , 2.22 ; 95 % CI , 1.34-3 .68 ) .
RESULTS	Among high-risk women , all intervention effects were stronger .
CONCLUSIONS	An intervention combining an easy-to-use , quick risk assessment tool with patient-centered risk reports at the point of care can successfully promote discussion of breast cancer risk reduction between patients and primary care physicians , particularly for high-risk women .
CONCLUSIONS	Next steps include scaling and dissemination of BreastCARE with integration into electronic medical record systems .

###24238592
BACKGROUND	The medical priority dispatch system ( MPDS ) assists lay rescuers in protocol-driven telephone-assisted cardiopulmonary resuscitation ( CPR ) .
OBJECTIVE	Our aim was to clarify which CPR instruction leads to sufficient compression depth .
METHODS	This was an investigator-blinded , randomized , parallel group , simulation study to investigate 10min of chest compressions after the instruction `` push down firmly 5cm '' vs. `` push as hard as you can . ''
METHODS	Primary outcome was defined as compression depth .
METHODS	Secondary outcomes were participants exertion measured by Borg scale , provider 's systolic and diastolic blood pressure , and quality values measured by the skill-reporting program of the Resusci ( ) Anne Simulator manikin .
METHODS	For the analysis of the primary outcome , we used a linear random intercept model to allow for the repeated measurements with the intervention as a covariate .
RESULTS	Thirteen participants were allocated to control and intervention .
RESULTS	One participant ( intervention ) dropped out after min 7 because of exhaustion .
RESULTS	Primary outcome showed a mean compression depth of 44.1 mm , with an inter-individual standard deviation ( SDb ) of 13.0 mm and an intra-individual standard deviation ( SDw ) of 6.7 mm for the control group vs. 46.1 mm and a SDb of 9.0 mm and SDw of 10.3 mm for the intervention group ( difference : 1.9 ; 95 % confidence interval -6.9 to 10.8 ; p = 0.66 ) .
RESULTS	Secondary outcomes showed no difference for exhaustion and CPR-quality values .
CONCLUSIONS	There is no difference in compression depth , quality of CPR , or physical strain on lay rescuers using the initial instruction `` push as hard as you can '' vs. the standard MPDS ( ) instruction `` push down firmly 5cm . ''

###25250647
BACKGROUND	Antioxidant donor pretreatment is one of the pharmacologic strategy proposed to prevent renal ischemia-reperfusion injuries and delayed graft function ( DGF ) .
BACKGROUND	The aim of the study was to investigate whether a donor pretreatment with N-acetylcysteine ( NAC ) reduces the incidence of DGF in adult human kidney transplant recipients .
METHODS	In this randomized , open-label , monocenter trial , 160 deceased heart-beating donors were allowed to perform 236 renal transplantations from September 2005 to December 2010 .
METHODS	Donors were randomized to receive , in a single-blind controlled fashion , 600 mg of intravenous NAC 1 hr before and 2 hr after cerebral angiography performed to confirm brain death .
METHODS	Primary endpoint was DGF defined by the need for at least one dialysis session within the first week or a serum creatinine level greater than 200 mol/L at day 7 after kidney transplantation .
RESULTS	The incidence of DGF was similar between donors pretreated with or without NAC ( 39/118 ; 33 % vs. 30/118 ; 25.4 % ; P = 0.19 ) .
RESULTS	Requirement for at least one dialysis session was not different between the NAC and No NAC groups ( 17/118 ; 14.4 % vs. 14/118 ; 11.8 % , P = 0.56 ) .
RESULTS	The two groups had comparable serum creatinine levels , estimated glomerular filtration rates , and daily urine output at days 1 , 7 , 15 , and 30 after kidney transplantation as well as at hospital discharge .
RESULTS	No difference in recipient mortality nor in 1-year kidney graft survival was observed .
CONCLUSIONS	Donor pretreatment with NAC does not improve delayed graft function after kidney transplantation .

###24649788
BACKGROUND	Some anesthesiologists consider combined spinal epidural ( CSE ) analgesia as superior alternative to continuous labor epidural ( CLE ) analgesia .
BACKGROUND	However , during CSE , even small doses of intrathecally administered local anesthetics with opioids induce almost instant analgesia that precludes the testing of epidural catheters as well as early appreciation of failed epidural catheters .
BACKGROUND	To overcome the shortcomings of CSE analgesia , dural puncture epidural ( DPE ) analgesia had been devised .
OBJECTIVE	The goals for the present study were to test whether DPE technique would provide superior and safer labor analgesia as compared to CLE technique .
METHODS	131 ASA Class I , II and III pregnant patients who requested labor epidural analgesia consented for their participation in this prospective randomized study .
METHODS	Group A patients received CLE analgesia for labor pain .
METHODS	Group B patients received DPE analgesia for labor pain .
RESULTS	After exclusion of nineteen patients , final comparative data was available for 112 patients only [ Group A ( n = 63 ) versus Group B ( n = 49 ) ] .
RESULTS	Per our analysis , the only positive aspect for DPE analgesia as compared to CLE analgesia was that patients who received DPE analgesia reported lower incidence for immediate failures of labor analgesia ( P = 0.04 ) .
RESULTS	However , there was higher incidence of paresthesias while performing successful dural punctures ( P < 0.0001 ) .
RESULTS	Pre-insertion epidural depth assessment with ultrasound ( n = 112 ) correlated positively with the air-filled loss of resistance syringe technique ( r = 0.88 ; P < 0.0001 ) .
CONCLUSIONS	DPE technique did not provide superior labor analgesia as compared to CLE technique .
CONCLUSIONS	Technically , fewer immediate failures in labor analgesia but higher incidence of paresthesias were observed with DPE technique .

###25269831
OBJECTIVE	To determine whether the addition of 26weeks of subcutaneous peginterferon -- 2b could reduce the requirement for systemic corticosteroids and conventional immunosuppressive medication in patients with Behet 's disease ( BD ) .
METHODS	We conducted a multicentre randomised trial in patients with BD requiring systemic therapy .
METHODS	Patients were randomised to 26weeks of peginterferon -- 2b in addition to their standard care or to standard care only and followed 6-monthly for 3years with BD activity scores and quality of life questionnaires .
METHODS	Patients at one centre had blood taken to measure regulatory T cells ( Tregs ) and Th17 cells .
RESULTS	72 patients were included .
RESULTS	At months 10-12 , while among the entire patient population there was no difference in the corticosteroid dose or immunosuppression use between the treatment groups ( adjusted OR 1.04 , 95 % CI 0.34 to 3.19 ) , post hoc analysis revealed that in patients who were on corticosteroids at baseline the corticosteroid requirement was significantly lower in the peginterferon -- 2b ( 6.5 ( 5-15 ) mg/day ) compared with the non-interferon group ( 10 ( 8.25-16 .5 ) mg/day , p = 0.039 ) .
RESULTS	Furthermore , there was a trend towards an improved quality of life that became significant by 36months ( p = 0.008 ) .
RESULTS	This was associated with a significant rise in Tregs and a decrease in Th17 cells which was still present at 1year and 6months after the interferon was stopped .
RESULTS	The safety profile was similar with adverse events in 10 % in both groups .
CONCLUSIONS	The addition of peginterferon -- 2b to the drug regime of BD patients did not significantly reduce their corticosteroid dose required at 1year .
CONCLUSIONS	However , in those on corticosteroids at baseline post hoc analysis demonstrated that the addition of peginterferon -- 2b did result in a significant reduction in corticosteroid dose with a significantly improved quality of life and trend to reduce other required immunosuppressive agents .
CONCLUSIONS	This effect was seen at 1year and associated with a rise in Tregs suggesting a possible mode for interferon action .
BACKGROUND	ISRCTN 36354474 ; EudraCT 2004-004301-18 .

###24491137
BACKGROUND	Low levels of physical activity are common in patients with chronic obstructive pulmonary disease ( COPD ) , and a sedentary lifestyle is associated with poor outcomes including increased mortality , frequent hospitalizations , and poor health-related quality of life .
BACKGROUND	Internet-mediated physical activity interventions may increase physical activity and improve health outcomes in persons with COPD .
METHODS	This manuscript describes the design and rationale of a randomized controlled trial that tests the effectiveness of Taking Healthy Steps , an Internet-mediated walking program for Veterans with COPD .
METHODS	Taking Healthy Steps includes an uploading pedometer , a website , and an online community .
METHODS	Eligible and consented patients wear a pedometer to obtain one week of baseline data and then are randomized on a 2:1 ratio to Taking Healthy Steps or to a wait list control .
METHODS	The intervention arm receives iterative step-count feedback ; individualized step-count goals , motivational and informational messages , and access to an online community .
METHODS	Wait list controls are notified that they are enrolled , but that their intervention will start in one year ; however , they keep the pedometer and have access to a static webpage .
CONCLUSIONS	Participants include 239 Veterans ( mean age 66.7 years , 93.7 % male ) with 155 randomized to Taking Healthy Steps and 84 to the wait list control arm ; rural-living ( 45.2 % ) ; ever-smokers ( 93.3 % ) ; and current smokers ( 25.1 % ) .
CONCLUSIONS	Baseline mean St. George 's Respiratory Questionnaire Total Score was 46.0 ; 30.5 % reported severe dyspnea ; and the average number of comorbid conditions was 4.9 .
CONCLUSIONS	Mean baseline daily step counts was 3497 ( + / - 2220 ) .
CONCLUSIONS	Veterans with COPD can be recruited to participate in an online walking program .
CONCLUSIONS	We successfully recruited a cohort of older Veterans with a significant level of disability including Veterans who live in rural areas using a remote national recruitment strategy .
BACKGROUND	Clinical Trials.gov NCT01102777 .

###24506576
OBJECTIVE	Methods to improve neurocognitive impairments are of important research interest .
OBJECTIVE	This study sought to examine the synergistic effects of neurocognitive rehabilitation and antipsychotics for schizophrenia .
METHODS	Subjects were 43 patients diagnosed with schizophrenia or schizoaffective disorder in a randomized trial of the effects of neurocognitive rehabilitation or a quasi-randomized experimental trial of supported employment with neurocognitive rehabilitation .
METHODS	We compared the effects of risperidone and aripiprazole in neurocognitive rehabilitation for schizophrenia .
METHODS	Subjects were divided into the following groups : ( i ) the control-risperidone group ( CR group ) ( n = 13 ) ; ( ii ) the rehabilitation-risperidone group ( RR group ) ( n = 9 ) ; ( iii ) the control-aripiprazole group ( CA group ) ( n = 10 ) ; and ( iv ) the rehabilitation-aripiprazole group ( RA group ) ( n = 11 ) .
METHODS	Subjects in the rehabilitation group were engaged in computer-based cognitive exercises ( 24 sessions ) with bridging group ( 12 sessions ) over 12 weeks .
METHODS	Psychiatric symptoms , neurocognitive functioning and social functioning assessments were evaluated at baseline and at 12 weeks .
RESULTS	A two-way anova with neurocognitive rehabilitation and antipsychotic medication as factors revealed a significant interaction effect on motor speed .
RESULTS	Working memory and motor speed significantly improved in the RA group compared with the CA group .
RESULTS	We found no significant improvements between the CR group and the RR group .
CONCLUSIONS	A synergistic effect of neurocognitive rehabilitation and aripiprazole was observed as improvement of motor speed .
CONCLUSIONS	In patients treated with aripiprazole , neurocognitive rehabilitation appeared to improve working memory and motor speed .
CONCLUSIONS	Further studies of synergistic effects of neurocognitive rehabilitation and antipsychotic medication are necessary to verify these findings .

###24279592
OBJECTIVE	The progression of heart failure is affected by several factors , including chronic stimulation of the - adrenoceptor .
OBJECTIVE	This clinical study was designed to measure the effects of thoracic epidural analgesia ( TEA ) on the plasma levels of norepinephrine ( NE ) , cAMP , and cGMP in patients with heart failure and assess the clinical implication of TEA .
METHODS	Forty patients with heart failure were randomly assigned to TEA ( TEA plus standard care ) and control groups ( standard care ) .
METHODS	The plasma concentrations of cAMP , cGMP , brain natriuretic peptide ( BNP ) , and NE were measured using ELISA before treatment , the second and fourth weeks of treatment .
RESULTS	The plasma concentrations of cAMP , cGMP , BNP , and NE in the TEA group were significantly reduced by the fourth week compared to their initial concentrations ( P < 0.01 , for all parameters ) and the control group ( P < 0.05 , P < 0.05 , P < 0.01 , and P < 0.05 , respectively ) .
RESULTS	The values for left ventricular end diastolic diameter ( LVEDD ) , ejection fraction ( EF ) , and fractional shortening ( FS ) in the TEA group improved significantly compared to their initial values and the control group .
RESULTS	However , the changes in levels for these indices in the control group were no statistical significant compared to the initial levels .
CONCLUSIONS	TEA can effectively decrease the plasma concentrations of cAMP and cGMP and improve cardiac function in patients with heart failure .
CONCLUSIONS	The decreased levels of NE and cAMP occurred before the improvement in cardiac function , indicating that the abnormal epidural signal transduction can be corrected in patients with heart failure .

###24326536
OBJECTIVE	To examine the impact of a personal health record ( PHR ) on medication-use safety among older adults .
BACKGROUND	Online PHRs have potential as tools to manage health information .
BACKGROUND	We know little about how to make PHRs accessible for older adults and what effects this will have .
METHODS	A PHR was designed and pretested with older adults and tested in a 6-month randomized controlled trial .
METHODS	After completing mailed baseline questionnaires , eligible computer users aged 65 and over were randomized 3:1 to be given access to a PHR ( n = 802 ) or serve as a standard care control group ( n = 273 ) .
METHODS	Follow-up questionnaires measured change from baseline medication use , medication reconciliation behaviors , and medication management problems .
RESULTS	Older adults were interested in keeping track of their health and medication information .
RESULTS	A majority ( 55.2 % ) logged into the PHR and used it , but only 16.1 % used it frequently .
RESULTS	At follow-up , those randomized to the PHR group were significantly less likely to use multiple non-steroidal anti-inflammatory drugs-the most common warning generated by the system ( viewed by 23 % of participants ) .
RESULTS	Compared with low/non-users , high users reported significantly more changes in medication use and improved medication reconciliation behaviors , and recognized significantly more side effects , but there was no difference in use of inappropriate medications or adherence measures .
CONCLUSIONS	PHRs can engage older adults for better medication self-management ; however , features that motivate continued use will be needed .
CONCLUSIONS	Longer-term studies of continued users will be required to evaluate the impact of these changes in behavior on patient health outcomes .

###24329424
BACKGROUND	People with chronic heart failure ( HF ) suffer from numerous symptoms that worsen quality of life .
BACKGROUND	The CASA ( Collaborative Care to Alleviate Symptoms and Adjust to Illness ) intervention was designed to improve symptoms and quality of life by integrating palliative and psychosocial care into chronic care .
OBJECTIVE	Our aim was to determine the feasibility and acceptability of CASA and identify necessary improvements .
METHODS	We conducted a prospective mixed-methods pilot trial .
METHODS	The CASA intervention included ( 1 ) nurse phone visits involving structured symptom assessments and guidelines to alleviate breathlessness , fatigue , pain , or depression ; ( 2 ) structured phone counseling targeting adjustment to illness and depression if present ; and ( 3 ) weekly team meetings with a palliative care specialist , cardiologist , and primary care physician focused on medical recommendations to primary care providers ( PCPs , physician or nurse practioners ) to improve symptoms .
METHODS	Study subjects were outpatients with chronic HF from a Veteran 's Affairs hospital ( n = 15 ) and a university hospital ( n = 2 ) .
METHODS	Measurements included feasibility ( cohort retention rate , medical recommendation implementation rate , missing data , quality of care ) and acceptability ( an end-of-study semi-structured participant interview ) .
RESULTS	Participants were male with a median age of 63 years .
RESULTS	One withdrew early and there were < 5 % missing data .
RESULTS	Overall , 85 % of 87 collaborative care team medical recommendations were implemented .
RESULTS	All participants who screened positive for depression were either treated for depression or thought to not have a depressive disorder .
RESULTS	In the qualitative interviews , patients reported a positive experience and provided several constructive critiques .
CONCLUSIONS	The CASA intervention was feasible based on participant enrollment , cohort retention , implementation of medical recommendations , minimal missing data , and acceptability .
CONCLUSIONS	Several intervention changes were made based on participant feedback .

###25488849
BACKGROUND	Because respiratory muscle function plays a strong role in exercise capacity and cardiopulmonary response to exercise , systematic training and measurement of respiratory muscle function should be considered in stroke patients .
BACKGROUND	The purpose of this study was to determine whether an individualized respiratory muscle training device combined with conventional physical therapy exercise can improve the pulmonary function and exercise capacity of stroke patients .
METHODS	Twenty stroke patients were randomly assigned to an exercise group ( n = 10 ) or a control group ( n = 10 ) .
METHODS	Over 4 weeks , each group participated in exercise training interventions 3 times per week .
METHODS	In each session , the control group received basic exercise treatments for 30 min , followed by an automated full-body workout for 20 min .
METHODS	The exercise group performed the same exercise regimen as the control group , as well as an additional respiratory muscle training regimen using a respiratory exercise device for 20 min .
RESULTS	Pulmonary function of forced vital capacity ( FVC ) , forced expiratory volume at 1 s ( FEV1 ) , FEV1/FVC , and peak expiratory flow ( PEF ) and exercise capacity of a 6-min walking test and Shortness of Breath Modified Borg Dyspnea Scale ( SBMBDS ) scores were assessed before and after the training .
RESULTS	A significant intergroup difference was observed in the FVC , FEV1 , PEF , 6MWT , and SBMBDS scores ( p < 0.05 ) .
CONCLUSIONS	These findings suggest that exercise of the respiratory muscles using an individualized respiratory device had a positive effect on pulmonary function and exercise capacity and may be used for breathing rehabilitation in stroke patients .

###25530111
BACKGROUND	Approximately , 20-30 % of patients with gastro-esophageal reflux disease ( GERD ) experience persistent symptoms despite treatment with proton pump inhibitors ( PPIs ) .
BACKGROUND	These patients may have underlying dysmotility ; therefore , targeting gastric motor dysfunction in addition to acid inhibition may represent a new therapeutic avenue .
BACKGROUND	The aim of this study was to assess the pharmacodynamic effect of the prokinetic agent revexepride ( a 5-HT4 receptor agonist ) in patients with GERD who have persistent symptoms despite treatment with a PPI .
METHODS	This was a phase II , exploratory , multicenter , randomized , placebo-controlled , double-blind , parallel-group study in patients with GERD who experienced persistent symptoms while taking a stable dose of PPIs ( ClinicalTrials.gov identifier : NCT01370863 ) .
METHODS	Patients were randomized to either revexepride ( 0.5 mg , three times daily ) or matching placebo for 4 weeks .
METHODS	Reflux events and associated characteristics were assessed by pH/impedance monitoring and disease symptoms were assessed using electronic diaries and questionnaires .
RESULTS	In total , 67 patients were enrolled in the study .
RESULTS	There were no significant differences between study arms in the number , the mean proximal extent or the bolus clearance times of liquid-containing reflux events .
RESULTS	Changes from baseline in the number of heartburn , regurgitation , and other symptom events were minimal for each treatment group and no clear trends were observed .
CONCLUSIONS	No clear differences were seen in reflux parameters between the placebo and revexepride groups .

###24953067
BACKGROUND	The hands of hospital personnel are considered to be important for colonization and infection of patients with Candida spp .
BACKGROUND	The aim of this study was to evaluate the effectiveness of different hand disinfectants in reducing the carriage of Candida species on the hands of hospital personnel .
METHODS	A controlled study was conducted at Duzce University School of Medicine Hospital .
METHODS	Eighty hospital personnel were included in the trial .
METHODS	Subjects were divided into 4 groups according to hand hygiene procedures : group 1 , hand rubbing with alcohol-based solution ; group 2 , hand washing with 4 % chlorhexidine gluconate ; group 3 , hand washing with 7.5 % povidone-iodine ; group 4 , hand washing with plain soap and water .
METHODS	The hands of all participants were tested by culture with the broth wash technique .
RESULTS	Hand carriage of Candida spp .
RESULTS	was lower in the 4 % chlorhexidine gluconate group ( 10.5 % , p = 0.006 ) , in the 7.5 % povidone-iodine group ( 18.7 % , p = 0.043 ) , and in the alcohol-based hand rub group ( 21.1 % , p = 0.048 ) compared to the group washing hands with plain soap and water ( 50 % ) .
CONCLUSIONS	The use of hand disinfectant containing antimicrobial agents is more effective than hand washing with water and soap in reducing carriage of Candida on the hands of hospital personnel .
CONCLUSIONS	It is recommended that hospital personnel use an antimicrobial hand disinfectant in units where there is a high risk of Candida infection .

###24885412
BACKGROUND	This study sought to examine the effect of targeted physical therapy with and without cranial nerve non-invasive neuromodulation ( CN-NINM ) , on the walking ability of people with MS who exhibited a dysfunctional gait .
BACKGROUND	We hypothesized that subjects who received electrical stimulation would have greater improvement than those who had a control device after a 14-week intervention .
BACKGROUND	Gait disturbance is a common problem for people with multiple sclerosis ( MS ) .
BACKGROUND	Current management may include exercise , pharmacology , functional electrical stimulation , compensatory strategies , use of assistive devices , and implanted electrical devices .
BACKGROUND	We have developed an effective rehabilitative strategy using neuromodulation of the cranial nerves via electrical stimulation of the tongue to enhance the plasticity of the brain .
METHODS	The study is a within-subject blinded randomized control design .
METHODS	Twenty chronic MS subjects with an identified gait disturbance were assigned to either an active or control group .
METHODS	Both groups completed a 14-week intervention program using a standardized combination of exercise and a device that provided electrical stimulation to the tongue .
METHODS	Those in the active group received electrical stimulation on the tongue that they could perceive .
METHODS	Those in the control group used a device that did not provide a physiologically significant stimulus and was not perceivable .
METHODS	Subjects were assessed with the Dynamic Gait Index ( DGI ) .
RESULTS	The DGI scores improved for both groups .
RESULTS	There were significant between-group differences , with the active group showing statistically greater improvement than the control group mean .
CONCLUSIONS	People with MS demonstrated improved gait with CN-NINM training in a pilot randomized controlled trial .
CONCLUSIONS	This study suggests that tongue-based neurostimulation may amplify the benefits of exercise for improving gait in people with chronic MS.

###24723147
BACKGROUND	Higher-level gait disorder ( HLGD ) in older adults is characterized by postural instability , stepping dysrhythmicity , recurrent falls and progressive immobility .
BACKGROUND	Cognitive impairments are frequently associated with HLGD .
OBJECTIVE	The aim of this study was to compare gait and cognitive performance before and after the use of rivastigmine in patients with HLGD , free from cognitive impairment or Parkinsonism .
METHODS	Fifteen non-demented patients with HLGD ( age 79.2 5.9 years ; 11 women ; Mini-Mental State Examination [ MMSE ] 28.3 1.4 ) received escalating doses of rivastigmine for 12 weeks in an open-label , pilot study .
METHODS	They were assessed before and after treatment ( week 0 and week 12 ) , and after a 4-week washout period ( week 16 ) .
METHODS	Assessments included the Mindstreams computerized neuropsychological battery , Activities-specific Balance Confidence Scale , State-Trait Anxiety Inventory , Geriatric Depression Scale , Timed Up and Go ( TUG ) test , gait speed and stride time variability .
METHODS	One-way multiple analysis of variance tests for repeated measures were used , and Pillai 's trace test was considered as robust to investigate significant differences .
RESULTS	The mean dose of rivastigmine during the 8-12 week period was 5.1 2.3 mg/day .
RESULTS	A positive effect was observed on the Mindstreams memory subscale and anxiety scores [ Pillai 's trace : F ( 6,724 ) = 0.508 , p = 0.010 ; and F ( 7,792 ) = 0.545 , p = 0.006 , respectively , over the course of the study ] as well as on mobility ( TUG test ) [ Pillai 's trace : F ( 4,863 ) = 0.448 ; p = 0.028 ] , whereas gait speed and stride time variability did not change .
CONCLUSIONS	The use of relatively low-dose rivastigmine did not affect gait speed and stride time variability ; however , the general mobility and anxiety were improved .
CONCLUSIONS	These preliminary results warrant a larger , randomized , placebo-controlled study .

###24248104
BACKGROUND	Accumulation of bacteria in the pharynx is one of the risk factors of pneumonia due to ventilation .
BACKGROUND	One of the methods of prevention from accumulation of bacteria in the pharynx is the use of oral solutions .
BACKGROUND	Chlorhexidine is considered as the gold standard , but it has various side effects .
OBJECTIVE	Present study was aimed to determine and compare anti-bacterial effects of the chlorhexidine gluconate 0.2 % , herbal mouthwash of Matrica ( chamomile extracts ) 10 % , PersicaTM 10 % and normal saline in intensive care unit patients .
METHODS	In this double blind randomized clinical trial , 80 patients who were admitted in ICU divided into four groups of 20 patients each one .
METHODS	Researchers applied PersicaTM to group one , chlorhexidine gluconate mouth wash 0.2 % to group two and third group received Matrica , finally in the control group , normal saline were used .
METHODS	In order to culturing of Staphylococcus aureus and S. pneumoniae , salivary samples were obtained without any stimulation after six minimums oral rinsing .
METHODS	The data were processed in SPSS17 software and analyzed by appropriate statistical tests .
RESULTS	Decreased rate of bacterial colonies after intervention in the whole four groups was significant ( p < 0.001 ) .
RESULTS	The mouth wash of chlorhexidine ( p < 0.001 ) , PersicaTM ( p : 0.008 ) and Matrica ( p : 0.01 ) had a significant antibacterial effect on S. aureus and S. pneumoniae ( p < 0.001 ) .
CONCLUSIONS	Herbal oral mouthwash of persica and matrica has the effect on S. pneumoniae and S. aureus of oropharynx area in mechanically ventilated patients .
CONCLUSIONS	However , there is a need for further research to be considered as an alternative to chlorhexidine for prevention of VALP in ICU patients .

###25119571
OBJECTIVE	Preliminary evaluation of efficacy and safety of uzara use in treatment of moderate and severe primary dysmenorrhea in comparison to ibuprofen .
METHODS	This randomized , comparative two way cross-over study comprised 60 single female students at Faculty of Medicine , Ain Shams University , Egypt , aged 19-28 years with moderate ( n = 46 ) or severe ( n = 14 ) primary dysmenorrhea .
METHODS	Participants were randomized to take either uzara ( 80 mg/8 hours for two doses , then 40 mg/8 hours ) then ibuprofen ( 400 mg/6 hours ) in two subsequent cycles or vice versa .
METHODS	The pain intensity , using VAS , was recorded immediately before taking the medication ( 0 hour ) and after 4 , 12 , 24 , 48-60 , 96-120 hours .
METHODS	Main outcome measures included effectiveness of pain relief defined as drop of VAS to 3 or less , patient 's global evaluation of the drug , absence from school , the use of a rescue medication , and , in those who continued the treatment , the pain intensity difference ( PID ) at different points after start of medication and its sum ( SPID ) .
RESULTS	Uzara was comparably effective to ibuprofen ( 78.3 % vs. 86.7 % of cycles ; respectively ) , with comparable rates of effectiveness on global evaluation ( being around 50 % for either drug ) , and rates of school absences ( 11.7 % vs. 13.3 % ; respectively ) .
RESULTS	The need for rescue medication was different ( 18.3 % and 10 % ; respectively ) , albeit with no statistical significance .
RESULTS	The means of PID at different time points and SPID were comparable , with significantly lower average mean of VAS scores compared to that felt with no medication ( 1.6 vs. 6.8 , p < 0.001 ) .
RESULTS	Side effects were less with uzara than ibuprofen ( 0 % vs. 8.3 % , p < 0.05 ) .
CONCLUSIONS	Uzara might be as effective as ibuprofen in management of primary dysmenorrhea but with less side effects .
CONCLUSIONS	These findings need to be confirmed by a properly designed trial with a larger sample size .
BACKGROUND	Current Controlled Trials ISRCTN25618258 .

###25254938
OBJECTIVE	We evaluated the efficacy and safety of add-on treatment with a 3-adrenoceptor agonist ( mirabegron ) for overactive bladder symptoms remaining after 1-blocker ( tamsulosin ) treatment in men with benign prostatic obstruction .
METHODS	Patients with benign prostatic obstruction with urinary urgency at least once per week and a total OABSS of 3 or more points after 8 or more weeks of treatment with tamsulosin were enrolled in the study .
METHODS	They were randomly allocated to receive 0.2 mg tamsulosin daily or 0.2 mg tamsulosin and 50 mg mirabegron daily for 8 weeks .
METHODS	The primary end point was change in total OABSS .
METHODS	Safety assessments included change in post-void residual urine volume and adverse events .
RESULTS	From January 2012 through September 2013 a total of 94 patients were randomized .
RESULTS	Of these patients 76 completed the protocol treatment .
RESULTS	In the full analysis set the change in total OABSS during the treatment period was significantly greater in the combination group than in the monotherapy group ( -2.21 vs -0.87 , p = 0.012 ) .
RESULTS	The changes in scores for urinary urgency , daytime frequency , International Prostate Symptom Score storage symptom subscore and quality of life index at 8 weeks were significantly greater in the combination group .
RESULTS	The change in post-void residual urine volume was significantly greater in the combination group .
RESULTS	Although 6 patients experienced adverse events in the combination group , urinary retention was observed in only 1 patient .
CONCLUSIONS	Combined tamsulosin and mirabegron treatment is effective and safe for patients with benign prostatic obstruction who have overactive bladder symptoms after tamsulosin monotherapy .

###24683916
OBJECTIVE	To report on oral-health-related characteristics , beliefs , and behaviours among participants in a randomised control trial of an intervention to prevent early childhood caries ( ECC ) among Mori children , and to determine whether there were any systematic differences between the intervention and control groups at baseline .
METHODS	Baseline measurements from a randomised control trial ( involving 222 pregnant Mori women allocated randomly to either Intervention or Delayed groups ) which is currently underway .
METHODS	The rohe ( tribal area ) of Waikato-Tainui .
METHODS	Self-report information collected on sociodemographic characteristics , pregnancy details , self-reported general and oral health and health-related behaviours , and oral health beliefs .
RESULTS	Other than those in the Delayed group being slightly older , on average , there were no significant differences between the two groups .
RESULTS	Some 37.0 % were expecting their first child .
RESULTS	Most reported good health ; 43.6 % were current smokers , and 26.4 % had never smoked .
RESULTS	Only 8.2 % were current users of alcohol .
RESULTS	Almost all were dentate , and 57.7 % described their oral health as fair or poor .
RESULTS	One in six had had toothache in the previous year ; 33.8 % reported being uncomfortable about the appearance of their teeth , and 27.7 % reported difficulty in eating .
RESULTS	Dental service-use was relatively low and symptom-related ; 78.9 % needed to see a dentist .
RESULTS	Overall , most of the sample believed that it was important to avoid sweet foods , visit dentists and to brush the teeth , while about half thought that using fluoride toothpaste and using floss were important .
RESULTS	Some 38.2 % felt that drinking fluoridated water was important .
RESULTS	Oral-health-related fatalism was apparent , with 74.2 % believing that most people usually get dental problems , 58.6 % believing that most people will need extractions at some stage , and that most children eventually get dental caries .
CONCLUSIONS	Mothers ' important role in nurturing the well-being of the young child includes the protection and maintenance of the growing child 's oral health ( or ukaipo niho ) .
CONCLUSIONS	The findings provide important insights into Mori mothers ' oral health knowledge , beliefs and practices .

###24607844
BACKGROUND	Several therapies have been used in the treatment of chronic low back pain ( LBP ) , including various exercise strategies and spinal manipulative therapy ( SMT ) .
BACKGROUND	A common belief is that spinal motion changes in particular ways in direct response to specific interventions , such as exercise or spinal manipulation .
OBJECTIVE	The purpose of this study was to assess changes in lumbar region motion for more than 12 weeks by evaluating four motion parameters in the sagittal plane and two in the horizontal plane in LBP patients treated with either exercise therapy or spinal manipulation .
METHODS	Secondary analysis of a subset of participants from a randomized clinical trial .
METHODS	One hundred ninety-nine study participants with LBP of more than 6 weeks ' duration who had spinal motion measures obtained before and after the period of intervention .
METHODS	Lumbar region spinal kinematics sampled using a six-degree-of-freedom instrumented spatial linkage system .
METHODS	Trained therapists collected regional lumbar spinal motion data at baseline and 12 weeks of follow-up .
METHODS	The lumbar region spinal motion data were analyzed as a total cohort and relative to treatment modality ( high dose , supervised low-tech trunk exercise , SMT , and a short course of home exercise and self-care advice ) .
METHODS	The study was supported by grants from Health Resources and Services Administration , Danish Agency for Science Technology and Innovation , Danish Chiropractors Research Foundation , and the University of Southern Denmark .
METHODS	No conflicts of interest reported .
RESULTS	For the cohort as a whole , lumbar region motion parameters were altered over the 12-week period , except for the jerk index parameter .
RESULTS	The group receiving spinal manipulation changed significantly in all , and the exercise groups in half , the motion parameters included in the analysis .
RESULTS	The spinal manipulation group changed to a smoother motion pattern ( reduced jerk index ) , whereas the exercise groups did not .
CONCLUSIONS	This study provides evidence that spinal motion changes can occur in chronic LBP patients over a 12-week period and that these changes are associated with the type of treatment .

###24616894
OBJECTIVE	To propose a rehabilitation protocol able to produce immediate and long-term beneficial effects on level of disability and overall performance in ADLs .
METHODS	Forty-one FM patients were randomized to an exercise and educational-behavioral programme group ( experimental group , EG = 21 ) or to a control group ( CG = 20 ) .
METHODS	Each subject was evaluated before , at the end ( T1 ) , and after 6 months ( T6 ) from the conclusion of the rehabilitation treatment using the Fibromyalgia Impact Questionnaire ( FIQ ) , the visual analogue scale ( VAS ) , the Health Assessment Questionnaire ( HAQ ) , the fatigue severity scale ( FSS ) , the 6-minute walking test ( 6MWT ) , tender points count ( TPC ) , and spinal active range of motion .
METHODS	The exercise protocol included 20 sessions consisting in self-awareness , stretching , strengthening , spine flexibility , and aerobic exercises , which patients were subsequently educated to perform at home .
RESULTS	The two groups were comparable at baseline .
RESULTS	At T1 , the EG showed a positive trend in FIQ , VAS , HAQ , and FSS scales and significant improvement in 6MWT and in most spinal active range of motion measurements ( P between 0.001 and 0.04 ) .
RESULTS	The positive results were maintained at the follow-up .
CONCLUSIONS	The proposed programme was well tolerated and produced immediate and medium-term beneficial effects improving function and strain endurance .
CONCLUSIONS	This trial is registered with DRKS00005071 on DRKS .

###25059727
BACKGROUND	An intracuff pressure of 80cm H2 O in the adult-sized laryngeal mask airway Supreme has been recommended to obtain a higher oropharyngeal leak pressure ( OLP ) .
BACKGROUND	However , the intracuff pressure for the higher OLP in the pediatric laryngeal mask airway Supreme could be different from that in the adult-sized laryngeal mask airway Supreme .
BACKGROUND	Thus , we measured and compared OLP at three intracuff pressures of 40 , 60 , and 80cm H2 O in the pediatric laryngeal mask airway Supreme .
METHODS	This study was designed as a randomized crossover study and enrolled 36 children , aged 0-108months and 5-30kg in weight .
METHODS	After insertion of the laryngeal mask airway Supreme , oropharyngeal leak pressure ( OLP ) was measured at intracuff pressures of 40 , 60 , and 80cm H2 O according to one of six sequences produced on the basis of 36 Williams crossover design .
METHODS	During the intraoperative period , the laryngeal mask airway Supreme was maintained using the last intracuff pressure of the allocated sequence .
METHODS	The intraoperative and postoperative complications were compared among three maintenance intracuff pressures .
RESULTS	OLP at the intracuff pressure of 60cm H2 O was significantly higher than that of 40cm H2 O ( 17.93.9 vs 16.94.2 cm H2 O , P = 0.004 ) and was comparable with that of 80cm H2 O ( 17.93.9 vs 17.84.6 cm H2 O , P = 0.938 ) .
RESULTS	There were no significant differences of intraoperative and postoperative complications among the three maintenance intracuff pressures .
CONCLUSIONS	Our results suggest that the use of an intracuff pressure of 60cm H2 O in pediatric laryngeal mask airway Supreme provides a higher OLP compared with 40cm H2 O.

###24511573
BACKGROUND	Experimental and clinical pain studies are conflicting regarding whether individuals report heightened or dampened pain sensitivity in the presence of other men or women .
OBJECTIVE	In the present preliminary study , two small medical record reviews of patients admitted for emergency care were conducted to examine the possibility that patients may report differential pain intensity to male and female health care examiners .
OBJECTIVE	The study also sought to determine whether these effects are moderated by and , thus , only detectable by examining patients at different pain ( debilitation ) levels .
METHODS	Pain intensity scores were extracted from two medical record reviews of patients admitted for emergency care ( n = 64 and n = 135 , respectively ) .
METHODS	Pain intensity was measured using an 11-point numerical scale during standard triage assessments and the sex of the examiner was recorded .
RESULTS	Mean pain scores reported to male and female emergency staff did not differ in either set of medical records .
RESULTS	However , when patients were split between low and high pain levels , male patients reported higher pain scores to male practitioners when experiencing relatively low pain levels , and both male and female patients reported higher pain scores to female practitioners when experiencing relatively high pain levels .
CONCLUSIONS	The statistical magnitudes of these effects were large , suggesting that this phenomenon may be a pervasive feature in clinical settings and experimental pain studies .
CONCLUSIONS	These preliminary findings warrant larger-scale investigations of social contextual influences on patient pain reports , which are necessary for creating more standardized protocols for reliably assessing and treating patient pain experiences .

###24410484
OBJECTIVE	To compare the effect of adding canrenone or hydrochlorothiazide ( HCTZ ) to valsartan/amlodipine combination on urinary albumin excretion ( UAE ) in microalbuminuric type 2 diabetic hypertensives .
METHODS	After a 2-week placebo period and after 4 weeks of valsartan 160 mg plus amlodipine 5 mg combination , 120 patients whose blood pressure ( BP ) was not controlled ( > 130/80 mmHg ) were randomized to canrenone 25 mg or HCTZ 12.5 mg in addition to the previous therapy for 24 weeks .
METHODS	After the first 6 weeks of triple therapy , canrenone or HCTZ doses were doubled in the patients whose BP was yet uncontrolled .
METHODS	At the end of each period ( placebo , dual combination and triple combination therapy ) , clinic and ambulatory BP measurements were recorded and 24 h UAE was evaluated .
RESULTS	Both triple combinations produced greater clinical and ambulatory BP reduction than dual therapy , with no difference between the two groups .
RESULTS	UAE was reduced by both regimens , but the decrease associated with canrenone add-on therapy was more pronounced .
RESULTS	At week 24 , UAE decreased by 45.3 % in the canrenone group and by 20.3 % in the HCTZ group ( p < 0.01 ) .
CONCLUSIONS	These findings indicate that , despite similar BP-lowering effect , the addition of canrenone to valsartan/amlodipine combination was more effective in reducing UAE than HCTZ addition .

###24819857
OBJECTIVE	To evaluate the effect of early aqueous suppressant treatment on Ahmed glaucoma valve ( AGV ) surgery outcomes .
METHODS	Randomized clinical trial .
METHODS	Ninety-four eyes of 94 patients with refractory glaucoma .
METHODS	After AGV implantation , 47 cases ( group 1 ) received topical timolol-dorzolamide fixed-combination drops twice daily when intraocular pressure ( IOP ) exceeded 10 mmHg , whereas 47 controls ( group 2 ) received conventional stepwise treatment when IOP exceeded target pressure .
METHODS	Main outcome measures included IOP and success rate ( 6 mmHg < IOP < 15 mmHg and IOP reduction of at least 30 % from baseline ) .
METHODS	Other outcome measures included best-corrected visual acuity , complications , and hypertensive phase frequency .
RESULTS	Groups 1 and 2 were both followed up for a mean of 4511.6 and 47.27.4 weeks , respectively ( P = 0.74 ) .
RESULTS	Mixed model analysis revealed a significantly greater IOP reduction in group 1 at all intervals ( P < 0.001 ) .
RESULTS	At 1 year , the cases exhibited a significantly higher success rate ( 63.2 % vs. 33.3 % ; P = 0.008 ) and reduced hypertensive phase frequency ( 23.4 % vs. 66.0 % ; P < 0.001 ) .
CONCLUSIONS	Early aqueous suppressant treatment may improve AGV implantation outcomes in terms of IOP reduction , success rate , and hypertensive phase frequency .

###24511883
OBJECTIVE	To assess clinician attitudes and experiences in Health eHearts , a quality recognition and financial incentive program using health information technology .
METHODS	Survey of physicians .
METHODS	A survey was administered to 140 lead clinicians at each participating practice .
METHODS	Survey domains included clinicians ' experiences and attitudes toward the selected clinical quality measures focused on cardiovascular care , use of electronic health records ( EHRs ) , technical assistance visits , quality measurement reports , and incentive payments .
METHODS	Responses were compared across groups of practices receiving financial incentives with those in the control ( no financial rewards ) .
RESULTS	Survey response rate was 74 % .
RESULTS	The majority of respondents reported receiving and reviewing the quality reports ( 89 % ) , agreed with the prioritization of measures ( 89 % ) , and understood the information given in the quality reports ( 95 % ) .
RESULTS	Over half of the respondents had a quality improvement visit ( 56 % ) , with incentive clinicians more likely to have had a visit compared with the control group ( 68 % vs 43 % , P = .01 ) .
RESULTS	The incentive group respondents ( 92 % ) were more likely to report using clinical decision support system alerts than control group respondents ( 82 % , P = .11 ) .
CONCLUSIONS	Clinicians in both incentive and control groups reported positive experiences with the program .
CONCLUSIONS	No differences were detected between groups regarding agreement with selected clinical measures or their relevance to the patient population .
CONCLUSIONS	However , clinicians in the incentive group were more likely to review quarterly performance reports and access quality improvement visits .
CONCLUSIONS	Incentives may be used to further engage clinicians operating in small independently owned practices to participate in quality improvement activities .

###24500152
BACKGROUND	Selenium is found in soils and is essential for human antioxidant defense and immune function .
BACKGROUND	In Malawi , low soil selenium and dietary intakes coupled with low plasma selenium concentrations in HIV infection could have negative consequences for the health of HIV-infected mothers and their exclusively breastfed infants .
OBJECTIVE	We tested the effects of lipid-based nutrient supplements ( LNS ) that contained 1.3 times the Recommended Dietary Allowance of sodium selenite and antiretroviral drugs ( ARV ) on maternal plasma and breast-milk selenium concentrations .
METHODS	HIV-infected Malawian mothers in the Breastfeeding , Antiretrovirals , and Nutrition study were randomly assigned at delivery to receive : LNS , ARV , LNS and ARV , or a control .
METHODS	In a subsample of 526 mothers and their uninfected infants , we measured plasma and breast-milk selenium concentrations at 2 or 6 ( depending on the availability of infant samples ) and 24 wk postpartum .
RESULTS	Overall , mean ( SD ) maternal ( range : 81.2 20.4 to 86.2 19.9 g/L ) and infant ( 55.6 16.3 to 61.0 15.4 g/L ) plasma selenium concentrations increased , whereas breast-milk selenium concentrations declined ( 14.3 11.5 to 9.8 7.3 g/L ) from 2 or 6 to 24 wk postpartum ( all P < 0.001 ) .
RESULTS	Compared with the highest baseline selenium tertile , low and middle tertiles were positively associated with a change in maternal plasma or breast-milk selenium from 2 or 6 to 24 wk postpartum ( both P < 0.001 ) .
RESULTS	With the use of linear regression , we showed that LNS that contained selenium and ARV were not associated with changes in maternal plasma and breast-milk selenium , but maternal selenium concentrations were positively associated with infant plasma selenium at 2 or 6 and 24 wk postpartum ( P < 0.001 ) regardless of the study arm .
CONCLUSIONS	Selenite supplementation of HIV-infected Malawian women was not associated with a change in their plasma or breast-milk selenium concentrations .
CONCLUSIONS	Future research should examine effects of more readily incorporated forms of selenium ( ie , selenomethionine ) in HIV-infected breastfeeding women .

###25785967
BACKGROUND	Skin and skin-structure infections are common in ambulatory settings .
BACKGROUND	However , the efficacy of various antibiotic regimens in the era of community-acquired methicillin-resistant Staphylococcus aureus ( MRSA ) is unclear .
METHODS	We enrolled outpatients with uncomplicated skin infections who had cellulitis , abscesses larger than 5 cm in diameter ( smaller for younger children ) , or both .
METHODS	Patients were enrolled at four study sites .
METHODS	All abscesses underwent incision and drainage .
METHODS	Patients were randomly assigned in a 1:1 ratio to receive either clindamycin or trimethoprim-sulfamethoxazole ( TMP-SMX ) for 10 days .
METHODS	Patients and investigators were unaware of the treatment assignments and microbiologic test results .
METHODS	The primary outcome was clinical cure 7 to 10 days after the end of treatment .
RESULTS	A total of 524 patients were enrolled ( 264 in the clindamycin group and 260 in the TMP-SMX group ) , including 155 children ( 29.6 % ) .
RESULTS	One hundred sixty patients ( 30.5 % ) had an abscess , 280 ( 53.4 % ) had cellulitis , and 82 ( 15.6 % ) had mixed infection , defined as at least one abscess lesion and one cellulitis lesion .
RESULTS	S. aureus was isolated from the lesions of 217 patients ( 41.4 % ) ; the isolates in 167 ( 77.0 % ) of these patients were MRSA .
RESULTS	The proportion of patients cured was similar in the two treatment groups in the intention-to-treat population ( 80.3 % in the clindamycin group and 77.7 % in the TMP-SMX group ; difference , -2.6 percentage points ; 95 % confidence interval [ CI ] , -10.2 to 4.9 ; P = 0.52 ) and in the populations of patients who could be evaluated ( 466 patients ; 89.5 % in the clindamycin group and 88.2 % in the TMP-SMX group ; difference , -1.2 percentage points ; 95 % CI , -7.6 to 5.1 ; P = 0.77 ) .
RESULTS	Cure rates did not differ significantly between the two treatments in the subgroups of children , adults , and patients with abscess versus cellulitis .
RESULTS	The proportion of patients with adverse events was similar in the two groups .
CONCLUSIONS	We found no significant difference between clindamycin and TMP-SMX , with respect to either efficacy or side-effect profile , for the treatment of uncomplicated skin infections , including both cellulitis and abscesses .
CONCLUSIONS	( Funded by the National Institute of Allergy and Infectious Diseases and the National Center for Advancing Translational Sciences , National Institutes of Health ; ClinicalTrials.gov number , NCT00730028 . )

###24937541
BACKGROUND	Insulin resistance and sympathetic nervous system overactivity are closely associated and contribute to cardiovascular risk .
OBJECTIVE	The objective of the study was to test the hypotheses that pharmacological improvement in insulin sensitivity would ( 1 ) attenuate sympathetic neural drive and ( 2 ) enhance neuronal norepinephrine uptake .
METHODS	A randomized , double-blind trial was conducted in 42 obese , unmedicated individuals with metabolic syndrome ( mean age 56 1 y , body mass index 34 0.6 kg/m ( 2 ) ) who received 12 weeks of pioglitazone ( PIO ; 15 mg for 6 wk , then 30 mg daily ) or matched placebo .
METHODS	Clinical measurements included whole-body norepinephrine kinetics [ spillover rate , plasma clearance , and the steady state ratio of tritiated 3,4-dihydroxyphenylglycol to tritiated norepinephrine ( [ ( 3 ) H ] - DHPG to [ ( 3 ) H ] - NE ) as an index of neuronal uptake-1 ] , muscle sympathetic nerve activity , spontaneous baroreflex sensitivity , euglycemic hyperinsulinemic clamp , oral glucose tolerance test , ambulatory blood pressure , and Doppler echocardiography .
RESULTS	PIO treatment increased glucose uptake by 35 % and was accompanied by significant reductions in diastolic blood pressure and improved left ventricular diastolic and endothelial function .
RESULTS	Resting muscle sympathetic nerve activity burst frequency decreased by -6 3 burst/min compared with baseline ( P = .03 ) , but the magnitude of change was not different from placebo ( P = .89 ) .
RESULTS	Norepinephrine spillover and clearance rates and baroreflex sensitivity were unchanged .
RESULTS	Post hoc subgroup analyses revealed an 83 % increase in [ ( 3 ) H ] - DHPG to [ ( 3 ) H ] - NE ratio in hyperinsulinemic ( P = .04 ) but not normoinsulinemic subjects ( time group interaction , P = .045 ) .
RESULTS	Change in [ ( 3 ) H ] - DHPG to [ ( 3 ) H ] - NE ratio correlated with improvements in diastolic blood pressure ( r = -0.67 , P = .002 ) , the ratio of early ( E ) to late ( A ) peak transmitral diastolic inflow velocity ( r = 0.62 , P = .008 ) , E wave deceleration time ( r = -0.48 , P = .05 ) , and insulin area under the curve0-120 during the oral glucose tolerance test ( r = -0.42 , P = .08 ) .
CONCLUSIONS	Compared with placebo , PIO does not affect resting sympathetic drive or norepinephrine disposition in obese subjects with metabolic syndrome .
CONCLUSIONS	Treatment induced changes in the [ ( 3 ) H ] - DHPG to [ ( 3 ) H ] - NE ratio related to reduction in hyperinsulinemia and improvements in diastolic function .

###25695849
BACKGROUND	Persons living with HIV ( PLWH ) who also use crack cocaine may have stressful , chaotic lives and typically do not engage in standard medical care that addresses a multitude of extenuating life circumstances .
BACKGROUND	Yoga/meditation ( YM ) improves quality of life ( QOL ) and biomarkers of stress , but the effect of this intervention is almost unknown in PLWH , particularly those who use crack cocaine .
OBJECTIVE	This pilot study sought to compare the feasibility and acceptability of 60-minute , twice-per-week sessions of YM for 2 months with those of no-contact control and to evaluate the effects of the intervention on QOL ( according to the Short Form-36 , Perceived Stress Scale [ PSS ] , and Impact of Events Scale [ IES ] ) and salivary cortisol and dehydroepiandrosterone sulfate ( DHEA-S ) among PLWH who use crack cocaine .
METHODS	Participants were randomly assigned to YM or no-contact control and were assessed at baseline , 2 months after the intervention , and 4 months ' follow-up .
RESULTS	The YM program was acceptable and feasible , with high overall attendance ( 89 % ) and individual participation in yoga sessions ( 83 % ) .
RESULTS	YM participants showed modest improvements on QOL .
RESULTS	The PSS total score and the IES intrusion score improved significantly 2 months after the intervention , but cortisol and DHEA-S did not change .
CONCLUSIONS	This pilot study showed a high level of feasibility and acceptability and modest effects on measures of QOL among PLWH who use crack cocaine .
CONCLUSIONS	The results suggest utility of YM as a simple , safe , and inexpensive format to improve QOL in a population that has many medical difficulties and extenuating stressors .

###25238118
BACKGROUND	The aim of the study was to compare prefeed abdominal circumference ( AC ) and gastric residual volume ( GRV ) as a measure of feed intolerance in very-low-birth-weight infants ( VLBW ) .
METHODS	Eighty VLBW infants were randomized to 2 groups ; feed intolerance was monitored by measuring either GRV group or prefeed AC group .
METHODS	The primary outcome was time to full enteral feeds ( 180 mL kg day ) .
METHODS	Other main outcome measures were feed interruption days , duration of parenteral nutrition , incidence of culture positive sepsis , necrotizing enterocolitis , mortality , and duration of hospital stay .
RESULTS	The median ( interquartile range ) time to achieve full feeds was 10 ( 9-13 ) versus 14 ( 12-17 .5 ) days in AC and GRV groups , respectively ( P < 0.001 ) .
RESULTS	Infants in AC group had fewer feed interruption days ( 0 [ 0-2 ] vs 2.0 [ 1 , 5 ] , P < 0.001 ) and shorter duration of parenteral nutrition ( P < 0.001 ) .
RESULTS	The incidence of culture-positive sepsis in AC and GRV groups was 17.5 % and 30 % , respectively ( P = 0.18 ) .
RESULTS	Duration of hospital stay and mortality were comparable in both the groups .
CONCLUSIONS	Prefeed AC as a measure of feed intolerance in VLBW infants may shorten the time taken to achieve full feeds .

###24671110
OBJECTIVE	The Framingham risk score ( FRS ) is one of the standard tools used to predict the incidence of coronary heart disease ( CHD ) .
OBJECTIVE	No previous study has investigated its efficacy for a Japanese population cohort .
OBJECTIVE	The purpose of this study was to develop new coronary prediction algorithms for the Japanese population in the manner of the FRS , and to compare them with the original FRS .
METHODS	Our coronary prediction algorithms for Japanese were based on a large population-based cohort study ( Suita study ) .
METHODS	The study population comprised 5,521 healthy Japanese .
METHODS	They were followed-up for 11.8 years on average , and 213 cases of CHD were observed .
METHODS	Multiple Cox proportional hazard model by stepwise selection was used to construct the prediction model .
RESULTS	Our coronary prediction algorithms for Japanese patients were based on a large populationbased cohort study ( the Suita study ) .
RESULTS	A multiple Cox proportional hazard model by stepwise selection was used to construct the prediction model .
RESULTS	The C-statistics showed that the new model had better accuracy than the original and recalibrated Framingham scores .
RESULTS	The net reclassification improvement ( NRI ) by the Suita score with the inclusion of CKD was 41.2 % ( P0 .001 ) compared with the original FRS .
RESULTS	The recalibration of the FRS slightly improved the efficiency of the prediction , but it was still worse than the Suita score with the CKD model .
RESULTS	The calibration analysis suggested that the original FRS and the recalibrated FRS overestimated the risk of CHD in the Japanese population .
RESULTS	The Suita score with CKD more accurately predicted the risk of CHD .
CONCLUSIONS	The FRS and recalibrated FRS overestimated the 10-year risk of CHD for the Japanese population .
CONCLUSIONS	A predictive score including CKD as a coronary risk factor for the Japanese population was more accurate for predicting CHD than the original Framingham risk scores in terms of the C-statics and NRI .

###24554246
OBJECTIVE	The aim of our study was to evaluate the success rate of fiberoptic-guided endotracheal intubation through an Intubating Laryngeal Mask Airway ( ILMA ) , a Cobra Perilaryngeal Airway ( Cobra PLA ) , and a C-Trach Laryngeal Mask Airway ( C-Trach ) in patients whose necks are stabilized in a hard cervical collar .
METHODS	One hundred and eighty ASA I-II patients were randomized to undergo endotracheal intubation after general anesthesia via an ILMA ( group ILMA ) , a C-Trach ( group C-Trach ) or a Cobra PLA ( group CPLA ) with the application of an appropriately-sized hard cervical collar .
METHODS	A fiberoptic bronchoscope was used for intubation via the ILMA and Cobra PLA .
METHODS	Rate of successful insertion of an endotracheal tube through the three devices was the primary aim .
METHODS	Other parameters compared were time taken for device insertion , endotracheal intubation , hemodynamic changes , incidence of hypoxia , and mucosal injury during the procedure .
METHODS	The incidence of postoperative sore throat was also compared between the three groups .
RESULTS	The success rates of intubation in the ILMA , C-Trach , and CPLA groups were 100 , 100 , and 98 % respectively .
RESULTS	The first-attempt success rate was significantly better with the C-Trach compared to Cobra PLA ( 100 vs. 85 % , p < 0.05 ) .
RESULTS	The time taken for device insertion was significantly more with the Cobra PLA as compared to that taken with an ILMA or a C-Trach ( 35.7 vs. 30.3 and 27.5 s , respectively ) .
RESULTS	Intubation through a C-Trach took the least amount of time ( 84.4 s ) as compared to an ILMA ( 117.9 s ) or a Cobra PLA ( 139.2 s ) .
RESULTS	The incidence of hypoxia and airway morbidity was similar between the groups .
CONCLUSIONS	The success rates of fiberoptic-guided endotracheal intubation through an ILMA and a Cobra PLA are similar to the success rate of intubation using a C-Trach in patients whose cervical spines are immobilized with a hard cervical collar .

###25682903
OBJECTIVE	To determine whether the sense of coherence ( SOC ) could predict the outcome of an 18-month lifestyle intervention program for subjects at risk of type 2 diabetes .
METHODS	Subjects at high risk of type 2 diabetes mellitus were recruited to a low-intensity lifestyle intervention program by their general practitioners .
METHODS	Weight reduction 5 % and improvement in exercise capacity of 10 % from baseline to follow-up indicated a clinically significant lifestyle change .
METHODS	SOC was measured using the 13-item SOC questionnaire .
RESULTS	The study involved 213 subjects with a mean body mass index of 37 ( SD 6 ) .
RESULTS	Complete follow-up data were obtained for 131 ( 62 % ) .
RESULTS	Twenty-six participants had clinically significant lifestyle changes .
RESULTS	There was a 21 % increase in the odds of a clinically significant lifestyle change for each point increase in the baseline SOC score ( odds ratio = 1.21 ; confidence interval = 1.11-1 .32 ) .
RESULTS	The success rate was 14 times higher in the highest SOC score tertile group compared with the lowest .
CONCLUSIONS	High SOC scores were good predictors of successful lifestyle change in subjects at risk of type 2 diabetes .
CONCLUSIONS	SOC-13 can be used in daily practice to increase clinical awareness on the impact of mastery on the outcome of life-style intervention programs .

###24517114
BACKGROUND	Teduglutide , a recombinant analog of human glucagon-like peptide ( GLP ) -2 , is a novel therapy recently approved for the treatment of adult patients with short bowel syndrome who are dependent on parenteral support .
BACKGROUND	Previous studies assessing the effect of GLP-2 on gastric emptying in humans have yielded inconsistent results , with some studies showing no effect and others documenting a GLP-2-dependent delay in gastric emptying .
BACKGROUND	The primary objective of this study was to assess the effect of teduglutide on gastric emptying of liquids in healthy subjects , as measured by the pharmacokinetics of acetaminophen .
METHODS	This double-blind , parallel-group , single-center study enrolled and randomized 36 healthy subjects ( 22 men , 14 women ) to receive subcutaneous doses of teduglutide 4 mg or placebo ( 2:1 ratio ; 23:13 ) once daily on Days 1 through 10 in the morning .
METHODS	Gastric emptying of a mixed nutrient liquid meal was assessed by measuring acetaminophen levels predose and at 0.25 , 0.5 , 0.75 , 1 , 1.25 , 1.5 , 2 , 3 , 3.5 , 4 , 5 , 6 , 8 , 10 , 12 , and 14 hours after administration of 1000 mg acetaminophen on Days 0 and 10 .
METHODS	The primary study endpoint was a pharmacokinetic analysis of acetaminophen absorption in subjects receiving teduglutide or placebo .
RESULTS	No significant differences in gastric emptying of liquids ( acetaminophen area under the concentration [ AUC ] vs time curve from time 0 to the last measurable concentration , AUC extrapolated to infinity , maximum concentration [ Cmax ] , and time to Cmax ) were observed on Day 10 in subjects receiving teduglutide 4 mg versus subjects receiving placebo .
RESULTS	There were no serious adverse events ( AEs ) , deaths , or discontinuations due to an AE reported during the study .
CONCLUSIONS	Teduglutide 4 mg/day for 10 days does not affect gastric emptying of liquids in healthy subjects as measured by acetaminophen pharmacokinetics .
CONCLUSIONS	No unexpected safety signals were observed .
BACKGROUND	This study was registered at ClinicalTrials.gov , identifier NCT01209351 .

###24503341
BACKGROUND	Asian Americans have the highest incidence of hepatocellular carcinoma ( HCC ) , the major form of primary liver cancer , of all ethnic groups in the United States .
BACKGROUND	Chronic hepatitis B virus ( HBV ) infection is the most common cause of HCC , and as many as 1 in 10 foreign-born Asian Americans are chronically infected with HBV .
BACKGROUND	We tested the effectiveness of a culturally tailored liver cancer education program for increasing screening for HBV among Chinese , Korean , and Vietnamese Americans residing in the Baltimore-Washington metropolitan area , from November 2009 through June 2010 .
METHODS	We used a cluster randomized controlled trial to recruit volunteer participants from community-based organizations ( CBOs ) in the Baltimore-Washington metropolitan area .
METHODS	We selected 877 participants by using a pretest survey .
METHODS	People were eligible to participate if they had not attended a hepatitis B-related education program in the past 5 years .
METHODS	The intervention group ( n = 441 ) received a 30-minute educational program , and the control group ( n = 436 ) received an educational brochure .
METHODS	After attending the educational program , the intervention group completed a post-education survey .
METHODS	Six months later , participants in both groups were followed up by telephone .
METHODS	Receipt of HBV screening was the outcome measure .
RESULTS	Approximately 79 % ( n = 688 ) of participants completed the 6-month follow-up telephone survey .
RESULTS	Among those who had not had HBV screening at baseline ( n = 446 ) , the adjusted odds of self-reported receipt of HBV screening at the 6-month follow-up to the educational program were significantly higher for the intervention group than for the control group ( odds ratio = 5.13 ; 95 % confidence interval , 3.14-8 .39 ; P < .001 ) .
RESULTS	Chinese Americans and Vietnamese Americans had significantly higher odds of having HBV screening in the 6-month period than Korean Americans .
CONCLUSIONS	Culturally tailored education programs that increase liver cancer awareness can be effective in increasing HBV screening among underserved Asian American populations .

###25891654
OBJECTIVE	Placental extract has been used as a therapeutic agent with application in various fields of medicine .
OBJECTIVE	Placental extract is well known for its effects on wound healing with anti-inflammatory , antiplatelet , and angiogenic effects and is also a biogenic modulator .
OBJECTIVE	The present study evaluated the effect of placental extract on wound healing , mouth opening , and postoperative patient discomfort in patients with oral submucous fibrosis treated with fibrotomy with buccal fat pad coverage and coronoidectomy .
METHODS	Ten subjects with oral submucous fibrosis who presented with mouth opening less than 20 mm were enrolled in the present prospective randomized controlled trial to assess the effects of placental extract on the fibrotomy wound covered with a pedicled buccal pad fat ( 5 patients allocated to the study group , group S and 5 to the control group , group C ) .
METHODS	The following criteria were used to analyze the postoperative effect of placental extract on fibrotomy wounds compared with that of the controls : subjective assessment of the wound , postoperative discomfort , and postoperative mouth opening assessed at 1 , 2 , and 4 weeks postoperatively .
RESULTS	The average difference in the preoperative and fourth week postoperative mouth opening for group C was 13.8 2.68 mm and was 21.20 2.77 mm in group S.
RESULTS	The median calculated for group C was a 15.0-mm increase in mouth opening and was 20.0 mm in group S.
CONCLUSIONS	The results obtained with topical application of placental extract on fibrotomy wound healing and postoperative mouth opening were superior to those of the control group in whom placental extract was not used .

###25379858
OBJECTIVE	To investigate the safety of minimal immunosuppression ( IS ) in liver transplantation ( LT ) .
BACKGROUND	The lack of long-term follow-up studies , including pathologic data , has led to a protean handling of IS in LT.
METHODS	Between February 2000 and September 2004 , 156 adults were enrolled in a prospective , randomized , double-blind , placebo-controlled minimization trial comparing tacrolimus placebo ( TAC-PLAC ) and TAC short-term steroid ( TAC-STER ) IS .
METHODS	All patients had a minimum clinical , biochemical , and histological follow-up of 5 years .
RESULTS	Five-year actual patient and graft survival rates in TAC-PLAC and TAC-STER groups were 78.1 % and 82.1 % ( P = 0.89 ) and 74.2 % and 76.9 % ( P = 0.90 ) , respectively .
RESULTS	Five-year biopsies were available in 112 ( 89.6 % ) of 125 survivors .
RESULTS	Twelve patients refused a biopsy because of their excellent evolution ; tissue material was insufficient in 1 patient ; 11 had normal liver tests ; and 2 patients had developed alcoholic and secondary biliary cirrhosis .
RESULTS	Histology was normal in 44 ( 39.3 % ) patients ; 35 ( 31.3 % ) had disease recurrence .
RESULTS	The remaining biopsies showed nonspecific chronic hepatitis ( 14.3 % ) , mild inflammatory infiltrates ( 10.7 % ) , and steatosis ( 3.5 % ) .
RESULTS	All findings were equally distributed between both groups .
RESULTS	In each group , 3 patients ( 4.8 % ) presented with acute cellular rejection after the first year and only 1 ( 0.9 % ) TAC-PLAC patient developed chronic rejection after IS withdrawal because of pneumonitis .
RESULTS	Arterial hypertension , diabetes mellitus , renal insufficiency , hypercholesterolemia , gout , and obesity were equally low in both groups .
CONCLUSIONS	Excellent long-term results can be obtained under minimal IS and absence of steroids .
CONCLUSIONS	TAC-based monotherapy is feasible in most adult liver recipients until 5 years of follow-up .

###25482300
OBJECTIVE	To evaluate the effects of combining the assessment of circulating high-sensitivity C-reactive protein ( hs-CRP ) with that of Epstein-Barr virus DNA ( EBV DNA ) in the pretherapy prognostication of nasopharyngeal carcinoma ( NPC ) .
METHODS	Three independent cohorts of NPC patients ( training set of n = 3113 , internal validation set of n = 1556 , and prospective validation set of n = 1668 ) were studied .
METHODS	Determinants of disease-free survival , distant metastasis-free survival , and overall survival were assessed by multivariate analysis .
METHODS	Hazard ratios and survival probabilities of the patient groups , segregated by clinical stage ( T1-2N0-1M0 , T3-4N0-1M0 , T1-2N2-3M0 , and T3-4N2-3M0 ) and EBV DNA load ( low or high ) alone , and also according to hs-CRP level ( low or high ) , were compared .
RESULTS	Elevated hs-CRP and EBV DNA levels were significantly correlated with poor disease-free survival , distant metastasis-free survival , and overall survival in both the training and validation sets .
RESULTS	Associations were similar and remained significant after excluding patients with cardiovascular disease , diabetes , and chronic hepatitis B. Patients with advanced-stage disease were segregated by high EBV DNA levels and high hs-CRP level into a poorest-risk group , and participants with either high EBV DNA but low hs-CRP level or high hs-CRP but low EBV DNA values had poorer survival compared with the bottom values for both biomarkers .
RESULTS	These findings demonstrate a significant improvement in the prognostic ability of conventional advanced NPC staging .
CONCLUSIONS	Baseline plasma EBV DNA and serum hs-CRP levels were significantly correlated with survival in NPC patients .
CONCLUSIONS	The combined interpretation of EBV DNA with hs-CRP levels led to refinement of the risks for the patient subsets , with improved risk discrimination in patients with advanced-stage disease .

###24327173
OBJECTIVE	Nerve growth factor ( NGF ) is a neurotrophin with therapeutic possibilities that extend from the nervous system to the eye .
OBJECTIVE	We tested the safety , maximal tolerated dose , pharmacokinetics , and antigenicity of a novel human recombinant NGF ( rhNGF ) eye-drop formulation in a phase I study .
METHODS	This prospective , randomized , double-masked , vehicle-controlled trial , sponsored by Domp SpA ( registered as NCT01744704 at ClinicalTrials.gov ) , enrolled 74 healthy volunteers ( 24 females , 50 males , age 40.211.8 years ) .
METHODS	Subjects were randomized in three cohorts to receive ( 1 ) a single eye-drop containing 0.0175 , 0.175 , or 0.7 g rhNGF ; ( 2 ) a single ascending dose of rhNGF eye drops three times a day for 1day ( total daily dose 2.1 , 6.3 , or 18.9 g ) , or vehicle ; or ( 3 ) a multiple ascending dose of rhNGF eye drops three times a day for 5days ( total dose 10.5 , 31.5 , or 94.5 g ) , or vehicle .
METHODS	Outcome measures included blood chemistry , urinalyses , vital signs , electrocardiograms ( ECGs ) , serum NGF antibodies , ocular and systemic adverse events ( AEs ) , visual acuity , tear function , intraocular pressure , fundus oculi , and ocular symptoms .
RESULTS	Administration of rhNGF eye drops did not result in a significant increase of circulating NGF levels and no antidrug antibodies were detected in serum .
RESULTS	No serious AEs were recorded , and a few mild , transient ocular AEs related to rhNGF administration were reported only at the highest concentration .
CONCLUSIONS	rhNGF eye drops were well tolerated , with no detectable clinical evidence of systemic AEs .
CONCLUSIONS	These results pave the way for the development of clinical trials on rhNGF in ophthalmology .

###25198033
BACKGROUND	The impact of intraoperative hydrodebrider sinus irrigation ( HSI ) during endoscopic sinus surgery ( ESS ) on postoperative inflammation , endoscopy , and patient-reported outcomes has not been studied .
METHODS	A clinical trial of 12 patients with symmetric chronic rhinosinusitis were prospectively randomized to HSI on one side after undergoing bilateral ESS .
METHODS	The contralateral side was not treated with any irrigation and served as an internal control .
METHODS	Preoperative computed tomography , endoscopic , 22-item Sino-Nasal Outcome Test ( SNOT-22 ) , and symptom visual analog scale ( VAS ) scores for each side were obtained .
METHODS	At 1 and 3 months postsurgery , endoscopy , SNOT-22 , and sinus VAS were recorded .
METHODS	Sinonasal mucus levels of interleukin ( IL ) -6 , IL-10 , IL-17a , and tumor necrosis factor ( TNF ) alpha were measured at the time of surgery , 1 and 3 months , postoperatively , from each side .
RESULTS	VAS scores improved on both sides ( p < 0.05 ) and SNOT-22 improved at all postoperative time points ( p < 0.05 ) .
RESULTS	Endoscopic scores of HSI-treated sides did not improve compared with baseline .
RESULTS	HSI had no additional significant impact on postoperative VAS at any time point .
RESULTS	HSI significantly decreased IL-17a levels when compared with the control side at 1 month ( p = 0.034 ) and 3 months ( p = 0.031 ) .
RESULTS	No significant change was seen in TNF-alpha , IL-6 , or IL-10 on either side at any time point .
CONCLUSIONS	Intraoperative HSI at the time of ESS failed to establish any improvement in postoperative endoscopy or most local cytokine levels after ESS .

###25351788
OBJECTIVE	This study examined whether changes in pH throughout the physiologic range would have a differential effect on central and peripheral factors associated with fatigue and force production during submaximal lower limb isometric exercise to task failure .
METHODS	Eight males completed three experimental trials [ 0.2 g kg ( -1 ) ammonia chloride ( ACD ) ; 0.3 g kg ( -1 ) calcium carbonate ( PLA ) ; or 0.3 g kg ( -1 ) sodium bicarbonate ( ALK ) ] , each consisting of submaximal calf contractions at 55 % of maximal voluntary contraction ( MVC ) to task failure .
METHODS	Every minute of the task subjects performed an MVC , coupled with stimulation of the tibial nerve during and immediately post MVC .
RESULTS	Time to task failure was not different between trials ( ACD 531 166 s , PLA 592 163 s , ALK 596 150 s ; p = 0.31 ) .
RESULTS	MVC force in all trials declined 29 % from the start of exercise to the fifth minute ( mean decline of 371 26 N ; p < 0.001 ) , however was not different between trials ( p = 0.21 ) .
RESULTS	Fatigue was mediated in all trials by central and peripheral factors , as declines in voluntary activation , V/M-wave in the soleus and the potentiated resting twitch amplitudes were evident throughout the task ( p < 0.05 ) .
RESULTS	Central fatigue appeared to be muscle specific , as reductions in central drive ( V/M-wave and rate of sEMG rise ) persisted in the soleus but not the medial gastrocnemius .
CONCLUSIONS	These data suggest that calf fatigue associated with intermittent , isometric contractions to task failure is unaffected by alterations in pH ; however , central drive reductions may be muscle specific .

###24954781
BACKGROUND	We aimed to assess the efficacy and safety of sequential or simultaneous telomerase vaccination ( GV1001 ) in combination with chemotherapy in patients with locally advanced or metastatic pancreatic cancer .
METHODS	TeloVac was a three-group , open-label , randomised phase 3 trial .
METHODS	We recruited patients from 51 UK hospitals .
METHODS	Eligible patients were treatment naive , aged older than 18 years , with locally advanced or metastatic pancreatic ductal adenocarcinoma , and Eastern Cooperative Oncology Group performance status of 0-2 .
METHODS	Patients were randomly assigned ( 1:1:1 ) to receive either chemotherapy alone , chemotherapy with sequential GV1001 ( sequential chemoimmunotherapy ) , or chemotherapy with concurrent GV1001 ( concurrent chemoimmunotherapy ) .
METHODS	Treatments were allocated with equal probability by means of computer-generated random permuted blocks of sizes 3 and 6 in equal proportion .
METHODS	Chemotherapy included six cycles of gemcitabine ( 1000 mg/m ( 2 ) , 30 min intravenous infusion , at days 1 , 8 , and 15 ) and capecitabine ( 830 mg/m ( 2 ) orally twice daily for 21 days , repeated every 28 days ) .
METHODS	Sequential chemoimmunotherapy included two cycles of combination chemotherapy , then an intradermal lower abdominal injection of granulocyte-macrophage colony-stimulating factor ( GM-CSF ; 75 g ) and GV1001 ( 056 mg ; days 1 , 3 , and 5 , once on weeks 2-4 , and six monthly thereafter ) .
METHODS	Concurrent chemoimmunotherapy included giving GV1001 from the start of chemotherapy with GM-CSF as an adjuvant .
METHODS	The primary endpoint was overall survival ; analysis was by intention to treat .
METHODS	This study is registered as an International Standard Randomised Controlled Trial , number ISRCTN4382138 .
RESULTS	The first patient was randomly assigned to treatment on March 29 , 2007 , and the trial was terminated on March 27 , 2011 .
RESULTS	Of 1572 patients screened , 1062 were randomly assigned to treatment ( 358 patients were allocated to the chemotherapy group , 350 to the sequential chemoimmunotherapy group , and 354 to the concurrent chemoimmunotherapy group ) .
RESULTS	We recorded 772 deaths ; the 290 patients still alive were followed up for a median of 60 months ( IQR 24-122 ) .
RESULTS	Median overall survival was not significantly different in the chemotherapy group than in the sequential chemoimmunotherapy group ( 79 months [ 95 % CI 71-88 ] vs 69 months [ 64-76 ] ; hazard ratio [ HR ] 119 , 9825 % CI 097-148 , p = 005 ) , or in the concurrent chemoimmunotherapy group ( 84 months [ 95 % CI 73-97 ] , HR 105 , 9825 % CI 085-129 , p = 064 ; overall log-rank of ( 2 ) 2df = 43 ; p = 011 ) .
RESULTS	The commonest grade 3-4 toxic effects were neutropenia ( 68 [ 19 % ] patients in the chemotherapy group , 58 [ 17 % ] patients in the sequential chemoimmunotherapy group , and 79 [ 22 % ] patients in the concurrent chemoimmunotherapy group ; fatigue ( 27 [ 8 % ] in the chemotherapy group , 35 [ 10 % ] in the sequential chemoimmunotherapy group , and 44 [ 12 % ] in the concurrent chemoimmunotherapy group ) ; and pain ( 34 [ 9 % ] patients in the chemotherapy group , 39 [ 11 % ] in the sequential chemoimmunotherapy group , and 41 [ 12 % ] in the concurrent chemoimmunotherapy group ) .
CONCLUSIONS	Adding GV1001 vaccination to chemotherapy did not improve overall survival .
CONCLUSIONS	New strategies to enhance the immune response effect of telomerase vaccination during chemotherapy are required for clinical efficacy .
BACKGROUND	Cancer Research UK and KAEL-GemVax .

###25122645
BACKGROUND	MicroRNAs ( miRNAs ) regulate genes in animals and plants and can be synthesized endogenously .
BACKGROUND	In milk , miRNAs are encapsulated in exosomes , thereby conferring protection against degradation and facilitating uptake by endocytosis .
BACKGROUND	The majority of bovine miRNAs have nucleotide sequences complementary to human gene transcripts , suggesting that miRNAs in milk might regulate human genes .
OBJECTIVE	We tested the hypotheses that humans absorb biologically meaningful amounts of miRNAs from nutritionally relevant doses of milk , milk-borne miRNAs regulate human gene expression , and mammals can not compensate for dietary miRNA depletion by endogenous miRNA synthesis .
METHODS	Healthy adults ( 3 men , 2 women ; aged 26-49 y ) consumed 0.25 , 0.5 , and 1.0 L of milk in a randomized crossover design .
METHODS	Gene expression studies and milk miRNA depletion studies were conducted in human cell cultures and mice , respectively .
METHODS	For comparison , feeding studies with plant miRNAs from broccoli were conducted in humans .
RESULTS	Postprandial concentration time curves suggest that meaningful amounts of miRNA ( miR ) -29 b and miR-200c were absorbed ; plasma concentrations of miR-1 did not change ( negative control ) .
RESULTS	The expression of runt-related transcription factor 2 ( RUNX2 ) , a known target of miR-29b , increased by 31 % in blood mononuclear cells after milk consumption compared with baseline .
RESULTS	When milk exosomes were added to cell culture media , mimicking postprandial concentrations of miR-29b and miR-200c , reporter gene activities significantly decreased by 44 % and 17 % , respectively , compared with vehicle controls in human embryonic kidney 293 cells .
RESULTS	When C57BL/6J mice were fed a milk miRNA-depleted diet for 4 wk , plasma miR-29b concentrations were significantly decreased by 61 % compared with miRNA-sufficient controls , i.e. , endogenous synthesis did not compensate for dietary depletion .
RESULTS	Broccoli sprout feeding studies were conducted as a control and elicited no detectable increase in Brassica-specific miRNAs .
CONCLUSIONS	We conclude that miRNAs in milk are bioactive food compounds that regulate human genes .

###25645166
BACKGROUND	Cigarette craving usually occurs in conjunction with unpleasant feelings , including stress , as part of a withdrawal syndrome .
BACKGROUND	Progressive muscle relaxation ( PMR ) , a behavioral technique used to reduce stress by concentrating on achieving muscle relaxation , may reduce levels of cigarette craving and other substance-related negative feelings and withdrawal symptoms .
METHODS	Demographic and cigarette use data were collected from 32 experienced smokers at the King Chulalongkorn Memorial Hospital , Bangkok , Thailand using the Semi-Structured Assessment for Drug Dependence and Alcoholism .
METHODS	Participants were asked to refrain from smoking for at least 3 hours before the visit ( acute abstinence ) and were randomly allocated to a 1-session PMR group ( n = 16 ) or a control activity group ( e.g. , reading newspaper , n = 16 ) .
METHODS	The intervention group was instructed to practice PMR individually in a quiet , private , air-conditioned room for about 20minutes .
METHODS	Craving , other substance-related feelings , and autonomic nervous responses ( e.g. , blood pressure and pulse rate ) were assessed immediately before and after the 1-session intervention .
RESULTS	There were no differences in demographics , cigarette use/dependence , and baseline craving characteristics between the PMR and control groups .
RESULTS	However , the control group had higher levels of high and paranoia feeling , and pulse rate than the PMR group at baseline .
RESULTS	After practicing PMR , but not after a control activity , smokers undergoing acute abstinence had significantly lower levels of cigarette craving , withdrawal symptoms , and systolic blood pressure than at baseline .
RESULTS	After controlling for baseline differences , abstaining smokers using PMR had lower levels of cigarette craving , withdrawal symptoms , and systolic blood pressure than smokers who undertook a control activity .
CONCLUSIONS	PMR significantly reduces cigarette craving , withdrawal symptoms , and blood pressure in smokers undergoing acute abstinence .
CONCLUSIONS	PMR may be used as an adjunct to cigarette dependency treatments .

###25455544
BACKGROUND	Inoperable aortic stenosis may be treated with either transcatheter aortic valve replacement ( TAVR ) or medical management ( MM ) with or without balloon aortic valvuloplasty ( BAV ) .
BACKGROUND	The aim of this study was to compare the long-term echocardiographic findings among TAVR , MM , and BAV in patients with severe , inoperable aortic stenosis .
METHODS	A total of 358 inoperable patients in the Placement of Aortic Transcatheter Valves trial were randomized to MM or TAVR .
METHODS	Echocardiograms obtained at baseline , 30 days , and 1 , 2 , and 3 years were analyzed by a central core laboratory .
RESULTS	At baseline , TAVR and MM were similar , with more frequent Society of Thoracic Surgeons score > 10 ( 51.7 % vs 65.0 % , P = .03 ) and larger end-systolic volumes ( 54.5 29.3 vs 69.1 48.0 mL , P = .03 ) in MM .
RESULTS	By 30 days after TAVR , mean aortic valve gradient had decreased ( from 43.8 14.7 to 10.0 4.3 mm Hg , P < .001 ) , ejection fraction had increased ( from 53.2 12.4 % to 56.7 10.0 % , P < .001 ) , and left ventricular ( LV ) mass index had decreased ( from 144.7 36.1 to 140.0 37.9 gm/m ( 2 ) , P < .05 ) .
RESULTS	After 1 year , aortic valve gradients and area were unchanged , while LV mass index had decreased by another 16 gm/m ( 2 ) ( to 124 gm/m ( 2 ) ) .
RESULTS	By 30 days after BAV , mean aortic valve gradient had decreased from 43.4 15.0 to 31.9 11.1 mm Hg , while ejection fraction and LV mass index were unchanged ; gradient reverted to baseline at 1 year .
RESULTS	No changes in gradients or mass were seen in MM patients .
CONCLUSIONS	TAVR results in immediate and sustained relief in pressure overload and improved LV systolic function , with continued regression of hypertrophy over 3 years .
CONCLUSIONS	Poor clinical results with BAV are explained by the modest and transient reductions in pressure overload with BAV , which were not accompanied by improved LV function or remodeling .
CONCLUSIONS	TAVR is the preferred treatment in eligible inoperable patients ( ClinicalTrials.gov identifier NCT00530894 ) .

###24239156
BACKGROUND	Statins are the most commonly prescribed drugs to reduce cardiometabolic risk .
BACKGROUND	Besides the well-known efficacy of such compounds in both preventing and treating cardiometabolic disorders , some patients experience statin-induced side effects .
BACKGROUND	We hypothesize that the use of natural bergamot-derived polyphenols may allow patients undergoing statin treatment to reduce effective doses while achieving target lipid values .
BACKGROUND	The aim of the present study is to investigate the occurrence of an enhanced effect of bergamot-derived polyphenolic fraction ( BPF ) on rosuvastatin-induced hypolipidemic and vasoprotective response in patients with mixed hyperlipidemia .
METHODS	A prospective , open-label , parallel group , placebo-controlled study on 77 patients with elevated serum LDL-C and triglycerides was designed .
METHODS	Patients were randomly assigned to a control group receiving placebo ( n = 15 ) , two groups receiving orally administered rosuvastatin ( 10 and 20mg/daily for 30 days ; n = 16 for each group ) , a group receiving BPF alone orally ( 1000 mg/daily for 30 days ; n = 15 ) and a group receiving BPF ( 1000 mg/daily given orally ) plus rosuvastatin ( 10mg/daily for 30 days ; n = 15 ) .
RESULTS	Both doses of rosuvastatin and BPF reduced total cholesterol , LDL-C , the LDL-C/HDL-C ratio and urinary mevalonate in hyperlipidemic patients , compared to control group .
RESULTS	The cholesterol lowering effect was accompanied by reductions of malondialdehyde , oxyLDL receptor LOX-1 and phosphoPKB , which are all biomarkers of oxidative vascular damage , in peripheral polymorphonuclear cells .
CONCLUSIONS	Addition of BPF to rosuvastatin significantly enhanced rosuvastatin-induced effect on serum lipemic profile compared to rosuvastatin alone .
CONCLUSIONS	This lipid-lowering effect was associated with significant reductions of biomarkers used for detecting oxidative vascular damage , suggesting a multi-action enhanced potential for BPF in patients on statin therapy .

###24257393
BACKGROUND	Patients undergoing surgery in the beach chair position ( BCP ) are at a risk of cerebral ischemia .
BACKGROUND	We evaluated the effect of arginine vasopressin ( AVP ) on hemodynamics and cerebral oxygenation during surgery in the BCP .
METHODS	Thirty patients undergoing shoulder surgery in BCP under propofol-remifentanil anesthesia were randomly allocated either to receive IV AVP 0.07 U/kg ( AVP group , N = 15 ) or an equal volume of saline ( control group , N = 15 ) 2 minutes before taking BCP .
METHODS	Mean arterial blood pressure ( MAP ) , heart rate ( HR ) , jugular venous bulb oxygen saturation ( SjvO2 ) , and regional cerebral tissue oxygen saturation ( SctO2 ) were measured after induction of anesthesia and before ( presitting in supine position ) and after patients took BCP .
RESULTS	AVP itself given before the positioning increased MAP and decreased SjvO2 and SctO2 ( P < 0.0001 ) , with HR unaffected .
RESULTS	Although MAP was decreased by BCP in both groups , it was higher in the AVP group ( P < 0.0001 ) .
RESULTS	While in BCP , HR remained unaltered in the control and decreased in the AVP group .
RESULTS	SjvO2 in BCP did not differ between the groups .
RESULTS	SctO2 was decreased by BCP in both groups , which was more pronounced in the AVP group until the end of study .
RESULTS	The incidence of hypotension ( 13 % vs 67 % ; P = 0.003 ) was less frequent , and that of cerebral desaturation ( > 20 % SctO2 decrease from presitting value ) ( 80 % vs 13 % ; P = 0.0003 ) was higher in the AVP group .
RESULTS	The incidence of jugular desaturation ( SjvO2 < 50 % ) was comparable between the groups .
CONCLUSIONS	A prophylactic bolus administration of AVP prevents hypotension associated with BCP in patients undergoing shoulder surgery under general anesthesia .
CONCLUSIONS	However , it was associated with regional cerebral but not jugular venous oxygen desaturation on upright positioning .

###24680148
OBJECTIVE	To explore the feasibility , safety , efficacy , and cosmetic outcomes of transvaginal endoscopic salpingectomy for tubal ectopic pregnancy .
METHODS	From May 2009 to May 2012 , we prospectively enrolled 40 patients , each of whom had been scheduled for a salpingectomy because of a tubal ectopic pregnancy , and randomized them into two groups : transvaginal endoscopic surgery and laparoscopic approach .
METHODS	We recorded the estimated blood loss , time of anal exhaust , postoperative pain score , length of stay , and scar assessment scale associated with transvaginal endoscopic access ( n = 18 ) ( natural orifice transluminal endoscopic surgery ) and laparoscopic salpingectomy ( n = 20 ) ( control group ) for tubal ectopic pregnancy .
METHODS	The transvaginal salpingectomy was performed with a double-channel endoscope through a vaginal puncture .
METHODS	A single surgeon performed the surgical procedures in patients in both groups .
RESULTS	The group that underwent the transvaginal endoscopic procedure reported lesser pain at all postoperative visits than the group that underwent the laparoscopic approach .
RESULTS	The duration of time for transvaginal endoscopic surgery was slightly longer than that for the laparoscopic approach .
RESULTS	However , there was no statistically significant difference between the two groups in the duration of operative time .
RESULTS	The group that underwent transvaginal endoscopic surgery was more satisfied with the absence of an external scar than the group that underwent the laparoscopic procedure , which left a scar .
RESULTS	The estimated blood loss , time of anal exhaust , and length of stay were the same in both groups .
CONCLUSIONS	The safety and efficacy of transvaginal endoscopic salpingectomy for tubal ectopic pregnancy are equivalent to those of the laparoscopic procedure .
CONCLUSIONS	Lesser postoperative pain and a more satisfactory cosmetic outcome were found with the transvaginal endoscopic procedure , making it the more preferred method and superior to the laparoscopic approach .

###25287156
OBJECTIVE	Acute pancreatitis has a highly variable clinical course .
OBJECTIVE	Early and reliable predictors for the severity of acute pancreatitis are lacking .
OBJECTIVE	Proteinuria appears to be a useful predictor of disease severity and outcome in a variety of clinical conditions .
OBJECTIVE	This study aims to investigate the predictive value of proteinuria on admission for the severity of acute pancreatitis compared with other commonly used predictors ; the APACHE II score , Modified Glasgow score and C-reactive protein ( CRP ) .
METHODS	This is a post-hoc analysis of 64 patients admitted with acute pancreatitis treated in one teaching hospital , who participated in a previous randomized trial .
METHODS	Proteinuria was defined as a Protein/Creatinine ( P/C ) ratio > 23 mg/mmol .
METHODS	The primary endpoint was severe acute pancreatitis .
METHODS	Secondary endpoints included infectious complications , need for invasive intervention , ICU stay and in-hospital mortality .
RESULTS	Proteinuria was present in 30/64 patients ( 47 % ) .
RESULTS	Eleven patients ( 17 % ) had severe acute pancreatitis .
RESULTS	There was no difference in incidence of severe acute pancreatitis between patients with and without proteinuria : 6/30 patients ( 20 % ) versus 5/34 patients ( 15 % ) respectively ( p = 0.58 ) .
RESULTS	Likewise , the occurrence of infectious complications , need for intervention and ICU stay and mortality did not differ significantly ( p = 0.58 , p = 0.99 , p = 0.33 and p = 0.60 respectively ) .
RESULTS	The diagnostic performance of the P/C ratio for the prediction of severe pancreatitis was inferior to the Modified Glasgow score ( p = 0.04 ) and CRP ( p = 0.03 ) .
CONCLUSIONS	Proteinuria on admission does not seem to be a reliable predictor for disease severity in acute pancreatitis .
CONCLUSIONS	The diagnostic performance of the P/C ratio is inferior to the Modified Glasgow score and CRP .

###24890747
OBJECTIVE	To compare the use of magnesium sulfate for 12 hours versus 24 hours in postpartum women with stable severe pre-eclampsia .
METHODS	In 2011 , an open randomized clinical trial was conducted with 120 postpartum women with severe pre-eclampsia who gave birth at a tertiary hospital in Brazil ; 60 women received magnesium sulfate for 24 hours and 60 for 12 hours .
METHODS	The analysis was by intention-to-treat and the intervention was not masked .
RESULTS	Abbreviated ( 12-hour ) magnesium sulfate therapy was associated with less exposure to the drug , and clinical outcomes were similar in both groups .
RESULTS	No woman developed eclampsia and there was no need to re-initiate treatment after completing the scheduled magnesium sulfate therapy in either group .
RESULTS	Magnesium sulfate therapy was extended in only three women in the 12-hour group .
RESULTS	In addition , in this group , significant reductions were found in the duration of postpartum use of an indwelling bladder catheter , the time to ambulation , and the time to maternal contact with the newborn .
CONCLUSIONS	Abbreviated postpartum magnesium sulfate therapy in patients with stable severe pre-eclampsia was associated with less drug exposure , similar outcomes , and benefits such as a reduction in the time to contact with the newborn .
BACKGROUND	clinicaltrials.gov NCT1408979 .

###24506775
BACKGROUND	Persistent facial erythema is the most common primary pathological feature of rosacea , the only treatment for which is brimonidine tartrate ( BT ) gel .
OBJECTIVE	To assess the relative bioavailability of topical BT gel in comparison with the ophthalmic BT solution .
METHODS	A pharmacokinetic study was conducted to compare intraindividual systemic exposures after dermal application of BT gel ( 007 % , 018 % and 05 % ) under maximal use conditions in patients with moderate-to-severe facial erythema associated with rosacea , and administration of BT ophthalmic solution 02 % .
RESULTS	Patients who received BT ophthalmic solution 02 % three times a day for 1 day had a mean Cmax of 54 28 pg mL ( -1 ) and a mean 0-24-h area under the curve ( AUC0-24 h ) of 568 277 pg h mL ( -1 ) .
RESULTS	Topical application of BT gel for 29 days resulted in quantifiable systemic exposure in 22 % , 48 % , 71 % and 79 % of patients who received BT gel 007 % twice daily , 018 % once daily , 018 % twice daily and 05 % once daily , respectively .
RESULTS	The mean Cmax values for the BT gels ranged between 13 and 25 pg mL ( -1 ) , and mean AUC0-24 h values ranged between 42 and 290 pg h mL ( -1 ) .
RESULTS	Systemic exposure increased with applied dose , with no drug accumulation for the duration of treatment .
RESULTS	The systemic exposure observed with the highest dose of BT gel ( 05 % once daily ) was significantly lower than the systemic levels observed for the ophthalmic solution .
RESULTS	02 % apply for all the concentrations .
CONCLUSIONS	The systemic safety profile of BT gel may be considered better than that of the ophthalmic solution .

###25823768
OBJECTIVE	Transoral incisionless fundoplication ( TIF ) was developed in an attempt to create a minimally invasive endoscopic procedure that mimics antireflux surgery .
OBJECTIVE	The objective of this trial was to evaluate effectiveness of TIF compared with proton pump inhibition in a population consisting of gastroesophageal reflux disease ( GERD ) patients controlled with proton pump inhibitors ( PPIs ) who opted for an endoscopic intervention over lifelong drug dependence .
METHODS	Patients with chronic GERD were randomized ( 2:1 ) for TIF or continuation of PPI therapy .
METHODS	American Society of Anesthesiologists > 2 , body mass index > 35kg/m ( 2 ) , hiatal hernia > 2cm , and esophageal motility disorders were exclusion criteria .
METHODS	Primary outcome measure was GERD-related quality of life .
METHODS	Secondary outcome measures were esophageal acid exposure , number of reflux episodes , PPI usage , appearance of the gastroesophageal valve , and healing of reflux esophagitis .
METHODS	Crossover for the PPI group was allowed after 6 months .
RESULTS	A total of 60 patients ( TIF n = 40 , PPI n = 20 , mean body mass index 26kg/m ( 2 ) , 37 male ) were included .
RESULTS	At 6 months , GERD symptoms were more improved in the TIF group compared with the PPI group ( P < 0.001 ) , with a similar improvement of distal esophageal acid exposure ( P = 0.228 ) compared with baseline .
RESULTS	The pH normalization for TIF group and PPI group was 50 % and 63 % , respectively .
RESULTS	All patients allocated for PPI treatment opted for crossover .
RESULTS	At 12 months , quality of life remained improved after TIF compared with baseline ( P < 0.05 ) , but no improvement in esophageal acid exposure compared with baseline was found ( P = 0.171 ) and normalization of pH was accomplished in only 29 % in conjunction with deteriorated valve appearances at endoscopy and resumption of PPIs in 61 % .
CONCLUSIONS	Although TIF resulted in an improved GERD-related quality of life and produced a short-term improvement of the antireflux barrier in a selected group of GERD patients , no long-term objective reflux control was achieved .

###26151998
OBJECTIVE	The aim was to investigate the effect of skin contact between mother and child in pain relief of full-term newborns during heel blood collection .
METHODS	The authors randomly divided 40 full-term newborns into two groups .
METHODS	In the experimental group , the newborn received kangaroo care from the mother before , during , and after the 20-minute heel blood collection .
METHODS	In the control group , the heel blood collection was performed under conventional conditions .
METHODS	The authors compared the two groups ' heart rate , oxygen saturation , facial expressions of pain , and duration of crying .
RESULTS	The two groups had no statistically significant difference in terms of gender , birth weight , mode of delivery , and gestational age ( p > 0.05 ) .
RESULTS	In the seven time periods during the puncture after ten seconds from the beginning and ten seconds after the end , the neonatal heart rates of the two groups changed and statistically significant differences were observed in the duration of heel blood collection , interaction and group factors , as well as in oxygen saturation ( p < 0.01 ) .
CONCLUSIONS	During heel blood collection , skin contact between the mother and child can relieve pain , reduce changes in heart rate , improve neonatal heel blood oxygen saturation , and enhance the emotional communication between the mother and child .

###24252064
OBJECTIVE	To investigate the effects of a suicide prevention programme on the levels of depression , self-esteem , suicidal ideation and spirituality in patients with mental illness .
BACKGROUND	Instances of suicide have significant correlations with depression , low self-esteem , suicidal ideation and a low level of spirituality in the victims .
BACKGROUND	Therefore , addressing depression , low self-esteem and suicidal ideation as suicide risk factors and increasing levels of spirituality can constitute an effective programme to prevent suicide among patients with mental illness .
METHODS	The study was a quasi-experimental study with a nonequivalent control group , nonsynchronised design .
METHODS	The study sample consisted of 45 patients with mental illness who had been admitted to the psychiatric unit in a university hospital in South Korea .
METHODS	The patients were assigned to control and experimental groups of 23 and 22 members , respectively .
METHODS	The suicide prevention programme was conducted with the experimental group over four weeks and included eight sessions ( two per week ) .
METHODS	The control group received only routine treatments in the hospital .
RESULTS	The experimental group that participated in the programme had significantly decreased mean scores for depression and suicidal ideation compared with the control group .
RESULTS	However , there were no significant differences in the mean scores for self-esteem and spirituality between the groups .
CONCLUSIONS	The suicide prevention programme might be usefully applied as a nursing intervention for patients hospitalised in psychiatric wards or clinics where the goals are to decrease depression and suicidal ideation .
CONCLUSIONS	Typical treatments for hospitalised patients with mental illness are not enough to prevent suicide .
CONCLUSIONS	Intervention for suicide prevention needs to apply an integrated approach .
CONCLUSIONS	The suicide prevention programme using an integrated approach is more effective in reducing depression and suicidal ideation in patients with mental illness than applying routine treatments in the hospital .

###25934175
BACKGROUND	This study aims for health gain and cost reduction in the care for people with long-term non-psychotic psychiatric disorders .
BACKGROUND	Present care for this population has a limited evidence base , is often open ended , little effective , and expensive .
BACKGROUND	Recent epidemiological data shows that 43.5 % of the Dutch are affected by mental illness during their life .
BACKGROUND	About 80 % of all patients receiving mental health services ( MHS ) have one or more non-psychotic disorders .
BACKGROUND	Particularly for this group , long-term treatment and care is poorly developed .
BACKGROUND	Care As Usual ( CAU ) currently is a form of low-structured treatment/care .
BACKGROUND	Interpersonal Community Psychiatric Treatment ( ICPT ) is a structured treatment for people with long-term , non-psychotic disorders , developed together with patients , professionals , and experts .
BACKGROUND	ICPT uses a number of evidence-based techniques and was positively evaluated in a controlled pilot study .
METHODS	Multi-centre cluster-randomized clinical trial : 36 professionals will be randomly allocated to either ICPT or CAU for an intervention period of 12months , and a follow-up of 6months .
METHODS	180 Patients between 18-65 years of age will be included , who have been diagnosed with a non-psychotic psychiatric disorder ( depressive , anxiety , personality or substance abuse disorder ) , have long-term ( > 2years ) or high care use ( > 1 outpatient contact per week or > 2 crisis contacts per year or > 1 inpatient admission per year ) , and who receive treatment in a specialized mental health care setting .
METHODS	The primary outcome variable is quality of life ; secondary outcomes are costs , recovery , general mental health , therapeutic alliance , professional-perceived difficulty of patient , care needs and social contacts .
CONCLUSIONS	No RCT , nor cost-effectiveness study , has been conducted on ICPT so far .
CONCLUSIONS	The empirical base for current CAU is weak , if not absent .
CONCLUSIONS	This study will fill this void , and generate data needed to improve daily mental health care .
BACKGROUND	Netherlands Trial Register ( NTR ) : 3988 .
BACKGROUND	Registered 13th of May 2013 .

###25558633
OBJECTIVE	Intraabdominal hypertension is a common occurrence , especially in intensive care unit patients , and it has high mortality and morbidity rates .
OBJECTIVE	The onset is commonly insidious and the poor prognosis is attributed to the long delay in diagnosis .
OBJECTIVE	Unfortunately , diagnosis is often delayed until loss of function in the affected tissues has already occurred .
OBJECTIVE	The aim of this study was to determine the predictive value of mean platelet volume ( MPV ) in assessing the risk of intraabdominal hypertension .
METHODS	Pneumoperitoneum during elective laparoscopic cholecystectomy was used as a model for intraabdominal hypertension .
METHODS	The study included 103 patients who met the inclusion criteria .
METHODS	MPV evaluations were made at 3 distinct times during laparoscopic cholecystectomy based on the actual intraabdominal pressure .
RESULTS	MPV values during preinsufflation , insufflation , and desufflation were 8.483 fL ( range : 6.7 to 11.1 ) , 8.901 fL ( range : 6.8 to 11.9 ) , and 8.538 fl ( range : 5.8 to 10.9 ) , respectively .
RESULTS	A statistically significant increase in MPV values was found during high intraabdominal pressures ( P < 0.001 ) .
RESULTS	A significant decrease in MPV values was also detected with desufflation ( P < 0.001 ) .
CONCLUSIONS	Increasing MPV values may reflect increased intraabdominal pressures , which may have a clinical implementation in intraabdominal hypertension .

###24978623
OBJECTIVE	This study examined the effectiveness of an Internet parenting education and support intervention among mothers with a serious mental illness ( SMI ) .
METHODS	Sixty mothers diagnosed with a schizophrenia spectrum or mood disorder who had primary/shared custody for a child 18 or younger were enrolled in a randomized controlled trial ( RCT ) with two conditions .
METHODS	The experimental condition involved participation in the online parental education course and a listserv co-moderated by a parent with a mental illness and a mental health professional .
METHODS	The control condition involved participation in online education healthy lifestyle course .
METHODS	Standardized measures were used at baseline and 3 months to assess outcomes .
METHODS	Using an intent-to-treat approach , group differences over time were assessed using a two-tailed independent sample t test on all dependent variables , including parental efficacy , skills , coping , support , and stress .
RESULTS	Participation in an online parenting intervention for mothers with a SMI enhanced parenting and coping skills , and decreased parental stress .
RESULTS	No support was found for improved efficacy or support .
CONCLUSIONS	This RCT establishes that mothers with a SMI are interested in and capable of receiving online parenting education and support .
CONCLUSIONS	Findings demonstrate that an online parenting intervention can improve parenting and coping skills and decrease parental stress .

###24599195
BACKGROUND	The literature comparing open and arthroscopic repair for glenohumeral instability is conflicting .
BACKGROUND	We performed a prospective , expertise-based , randomized clinical trial to compare open shoulder stabilization with arthroscopic shoulder stabilization by measuring quality-of-life outcomes and recurrence rates at two years among patients treated for traumatic anterior shoulder instability .
METHODS	Computer-generated , variable-block-size , concealed randomization allocated 196 patients to either the open-repair group ( n = 98 ) or the arthroscopic-repair group ( n = 98 ) .
METHODS	An expertise-based randomization design was employed to avoid a differential bias in terms of physician experience .
METHODS	Outcomes were measured at baseline , at three and six months postoperatively , and at one and two years postoperatively with use of the Western Ontario Shoulder Instability Index ( WOSI ) and the American Shoulder and Elbow Surgeons ( ASES ) functional outcome scale .
METHODS	Recurrent instability was also analyzed .
RESULTS	There were no significant differences in outcome scores at baseline .
RESULTS	At two years , seventy-nine patients in the open group and eighty-three patients in the arthroscopic group were available for follow-up .
RESULTS	There was no significant difference in mean WOSI scores between the groups ; the mean WOSI score ( and standard deviation ) for the open group was 85.2 20.4 ( 95 % confidence interval [ CI ] = 80.5 to 89.8 ) , and for the arthroscopic group , 81.9 19.8 ( 95 % CI = 77.4 to 86.4 ) ; p = 0.31 .
RESULTS	There was also no significant difference in mean ASES scores : 91.4 12.7 ( 95 % CI = 88.5 to 94.4 ) for the open group and 88.2 15.9 ( 95 % CI = 84.6 to 91.8 ) for the arthroscopic group ; p = 0.17 .
RESULTS	Recurrence rates at two years were significantly different : 11 % in the open group and 23 % in the arthroscopic group ( p = 0.05 ) .
RESULTS	Recurrent instability was more likely in patients with a preoperative Hill-Sachs lesion and in male patients who were twenty-five years old and younger .
RESULTS	There was no significant difference in shoulder motion between the groups at two years .
CONCLUSIONS	There was no difference between open and arthroscopic repair in terms of patient quality of life .
CONCLUSIONS	Open repair resulted in a significantly lower risk of recurrence .
CONCLUSIONS	Secondary outcome data from this trial suggest that open surgical repair may be recommended to reduce the risk of recurrent instability in younger male patients with a Hill-Sachs lesion .

###25610872
OBJECTIVE	To compare the efficacy , safety , and patient 's perception of two prostaglandin E2 application methods for induction of labour .
METHODS	Above 36th weeks of gestation , all women , who were admitted to hospital for induction of labour , were prospectively randomised to intravaginal 1 mg or intracervical 0.5 mg irrespective of cervical Bishop score .
METHODS	The main outcome variables were induction-to-delivery interval , number of foetal blood samples , PDA rate , rate of oxytocin augmentation , rate of vaginal delivery , and patient 's perception using semantic differential questionnaire .
RESULTS	Thirty-nine patients were enrolled in this study .
RESULTS	There was no statistical significant difference between the two groups in regard to perceptions of induction .
RESULTS	The median induction delivery time using intravaginal versus intracervical administration was 29.9 versus 12.8 hours , respectively ( P = 0.04 ) .
RESULTS	No statistically difference between the groups was detected in regard to parity , gestation age , cervical Bishop score , number of foetal blood samples , PDA rate , rate of oxytocin augmentation , and mode of birth .
CONCLUSIONS	Irrespective of the cervical Bishop Score , intracervical gel had a shorter induction delivery time without impingement on the women 's perception of induction .

###25286986
BACKGROUND	Patients with distributive shock who require high dose vasopressors have a high mortality .
BACKGROUND	Angiotensin II ( ATII ) may prove useful in patients who remain hypotensive despite catecholamine and vasopressin therapy .
BACKGROUND	The appropriate dose of parenteral angiotensin II for shock is unknown .
METHODS	In total , 20 patients with distributive shock and a cardiovascular Sequential Organ Failure Assessment score of 4 were randomized to either ATII infusion ( N = 10 ) or placebo ( N = 10 ) plus standard of care .
METHODS	ATII was started at a dose of 20 ng/kg/min , and titrated for a goal of maintaining a mean arterial pressure ( MAP ) of 65 mmHg .
METHODS	The infusion ( either ATII or placebo ) was continued for 6 hours then titrated off .
METHODS	The primary endpoint was the effect of ATII on the standing dose of norepinephrine required to maintain a MAP of 65 mmHg .
RESULTS	ATII resulted in marked reduction in norepinephrine dosing in all patients .
RESULTS	The mean hour 1 norepinephrine dose for the placebo cohort was 27.629.3 mcg/min versus 7.412.4 mcg/min for the ATII cohort ( P = 0.06 ) .
RESULTS	The most common adverse event attributable to ATII was hypertension , which occurred in 20 % of patients receiving ATII .
RESULTS	30-day mortality for the ATII cohort and the placebo cohort was similar ( 50 % versus 60 % , P = 1.00 ) .
CONCLUSIONS	Angiotensin II is an effective rescue vasopressor agent in patients with distributive shock requiring multiple vasopressors .
CONCLUSIONS	The initial dose range of ATII that appears to be appropriate for patients with distributive shock is 2 to 10 ng/kg/min .
BACKGROUND	Clinicaltrials.gov NCT01393782 .
BACKGROUND	Registered 12 July 2011 .

###25592254
BACKGROUND	Asymptomatic and symptomatic malaria during pregnancy has consequences for both mother and her offspring .
BACKGROUND	Unfortunately , there is insufficient information on the safety and efficacy of most antimalarials in pregnancy .
BACKGROUND	Indeed , clinical trials assessing antimalarial treatments systematically exclude pregnancy for fear of teratogenicity and embryotoxicity .
BACKGROUND	The little available information originates from South East Asia while in sub-Saharan Africa such information is still limited and needs to be provided .
METHODS	A Phase 3 , non-inferiority , multicentre , randomized , open-label clinical trial on safety and efficacy of 4 ACT when administered during pregnancy was carried out in 4 African countries : Burkina Faso , Ghana , Malawi and Zambia .
METHODS	This is a four arm trial using a balanced incomplete block design .
METHODS	Pregnant women diagnosed with malaria are randomised to receive either amodiaquine-artesunate ( AQ-AS ) , dihydroartemisinin-piperaquine ( DHA-PQ ) , artemether-lumefantrine ( AL ) , or mefloquine-artesunate ( MQAS ) .
METHODS	They are actively followed up until day 63 post-treatment and then monthly until 4-6 weeks post-delivery .
METHODS	The offspring is visited at the time of the first birthday .
METHODS	The primary endpoint is treatment failure ( PCR adjusted ) at day 63 and safety profiles .
METHODS	Secondary endpoints included PCR unadjusted treatment failure up to day 63 , gametocyte carriage , Hb changes , placenta malaria , mean birth weight and low birth weight .
METHODS	The primary statistical analysis will use the combined data from all 4 centres , with adjustment for any centre effects , using an additive model for the response rates .
METHODS	This will allow the assessment of all 6 possible pair-wise treatment comparisons using all available data .
CONCLUSIONS	The strength of this trial is the involvement of several African countries , increasing the generalisability of the results .
CONCLUSIONS	In addition , it assesses most ACTs currently available , determining their relative ' - value - ' compared to others .
CONCLUSIONS	The balanced incomplete block design was chosen because using all 4-arms in each site would have increased complexity in terms of implementation .
CONCLUSIONS	Excluding HIV-positive pregnant women on antiretroviral drugs may be seen as a limitation because of the possible interactions between antiretroviral and antimalarial treatments .
CONCLUSIONS	Nevertheless , the results of this trial will provide the evidence base for the formulation of malaria treatment policy for pregnant women in sub-Saharan Africa .

###26242435
BACKGROUND	The current evidence supports the clinical benefits of late umbilical cord clamping .
BACKGROUND	These benefits include increased blood volume and total body iron .
BACKGROUND	Furthermore , delayed cord clamping facilitates the transplantation of stem cells , which helps the development of infant bodily systems .
BACKGROUND	However , due to concerns related to postpartum hemorrhaging and neonate jaundice , most maternity units still clamp the cord immediately after a child is born .
OBJECTIVE	This study investigates the impact of delaying cord clamping on neonatal jaundice and postpartum hemorrhage .
METHODS	A randomized , controlled trial was conducted at a regional teaching hospital in northern Taiwan .
METHODS	One hundred and five healthy nulliparous women at 36 weeks of pregnancy were included and allocated randomly to the experiment group ( n = 44 ) and the control group ( n = 61 ) .
METHODS	Participants in the experiment group received delayed cord clamping ( DCC ) at 3 minutes after delivery .
METHODS	Participants in the control group received early cord clamping ( ECC ) at around 1 minute after delivery .
METHODS	Clinical measures of the outcomes were measured by the infant transcutaneous bilirubin levels ( TcB ) and postpartum hemorrhage at birth .
METHODS	A structured questionnaire and biophysical measures were used to collect data on participant demographics , obstetrical information , maternal blood loss at birth , neonate weight and TcB level at hospitalization , and whether or not the infant received phototherapy at 4-7 days postpartum .
RESULTS	Overall , there was no significant difference between the two groups in terms of neonatal jaundice , maternal hemorrhage at birth , and phototherapy rates at time of hospitalization and at 4-7 days postpartum .
CONCLUSIONS	The findings of the present study support that late umbilical cord clamping does not increase the risk of maternal postpartum hemorrhaging or neonate jaundice .
CONCLUSIONS	Thus , we suggest that clinicians inform clients during prenatal classes of the benefits of delayed cord clamping and also use current , evidence-based knowledge to dispel client worries regarding the dangers to maternal-neonate health of delayed cord clamping .

###25056766
OBJECTIVE	Before the introduction of the tension-free vaginal tape ( TVT ) procedure for the treatment of female stress urinary incontinence , the colposuspension operation was regarded as the `` gold standard '' procedure .
OBJECTIVE	The laparoscopic variant of the colposuspension was introduced as a less invasive operation .
OBJECTIVE	The aim of the present trial was to compare the new minimally invasive TVT procedure with laparoscopic mesh colposuspension ( LCM ) .
METHODS	A multicenter randomized clinical trial conducted in six public hospitals in Finland including primary cases of stress incontinence .
METHODS	Objective treatment success criteria were a negative stress test and no retreatment for stress incontinence .
METHODS	Patient satisfaction was assessed by Patients Global Impression of Improvement , a visual analog scale , and the Urinary Incontinence Severity Score .
RESULTS	Of 128 randomized patients , 121 underwent the allocated operation .
RESULTS	At the 5-year follow-up 77 % in the TVT group and 84 % in the LCM group could be assessed according to the protocol .
RESULTS	The objective cure rate was significantly higher in the TVT group ( 94 % ) than in the LCM group ( 78 % ) .
RESULTS	Subjective treatment satisfaction ( completely satisfied with the procedure ) was significantly higher in the TVT group ( 64 % ) than in the LCM group ( 51 % ) .
CONCLUSIONS	By per protocol analysis both objective and subjective cure rates were significantly higher in the TVT group than in the LCM group .
CONCLUSIONS	If cases that were lost to follow-up were regarded as failures , the intension-to-treat analysis found no difference between the groups .

###24835009
BACKGROUND	Zinc treatment shortens diarrhea episodes and can prevent future episodes .
BACKGROUND	In rural Africa , most children with diarrhea are not brought to health facilities .
BACKGROUND	In a village-randomized trial in rural Kenya , we assessed if zinc treatment might have a community-level preventive effect on diarrhea incidence if available at home versus only at health facilities .
METHODS	We randomized 16 Kenyan villages ( 1,903 eligible children ) to receive a 10-day course of zinc and two oral rehydration solution ( ORS ) sachets every two months at home and 17 villages ( 2,241 eligible children ) to receive ORS at home , but zinc at the health-facility only .
METHODS	Children 's caretakers were educated in zinc/ORS use by village workers , both unblinded to intervention arm .
METHODS	We evaluated whether incidence of diarrhea and acute lower respiratory illness ( ALRI ) reported at biweekly home visits and presenting to clinic were lower in zinc villages , using poisson regression adjusting for baseline disease rates , distance to clinic , and children 's age .
RESULTS	There were no differences between village groups in diarrhea incidence either reported at the home or presenting to clinic .
RESULTS	In zinc villages ( 1,440 children analyzed ) , 61.2 % of diarrheal episodes were treated with zinc , compared to 5.4 % in comparison villages ( 1,584 children analyzed , p < 0.0001 ) .
RESULTS	There were no differences in ORS use between zinc ( 59.6 % ) and comparison villages ( 58.8 % ) .
RESULTS	Among children with fever or cough without diarrhea , zinc use was low ( < 0.5 % ) .
RESULTS	There was a lower incidence of reported ALRI in zinc villages ( adjusted RR 0.68 , 95 % CI 0.46-0 .99 ) , but not presenting at clinic .
CONCLUSIONS	In this study , home zinc use to treat diarrhea did not decrease disease rates in the community .
CONCLUSIONS	However , with proper training , availability of zinc at home could lead to more episodes of pediatric diarrhea being treated with zinc in parts of rural Africa where healthcare utilization is low .
BACKGROUND	ClinicalTrials.gov NCT00530829 .

###25627874
OBJECTIVE	A study was undertaken to test in a subgroup reanalysis of the URICO-ICTUS trial whether uric acid is superior to placebo in improving the functional outcome in patients with acute stroke and hyperglycemia .
METHODS	Patients were part of the URICO-ICTUS trial , a double-blind study that compared the administration of uric acid versus placebo in stroke patients treated with alteplase within 4.5 hours of onset .
METHODS	The effect of therapy on the rate of excellent outcome at 90 days ( modified Rankin Scale2 ) in each tertile of admission glucose was assessed with multivariate adjusted models in 409 of the 421 randomized patients who had available pretreatment glucose levels .
METHODS	The effect of therapy on infarct growth was assessed in 72 patients who had longitudinal multimodal brain imaging .
RESULTS	Uric acid was associated with an increased rate of excellent outcome in patients with glucose levels in the upper tertile range ( odds ratio [ OR ] = 2.9 , 95 % confidence interval [ CI ] = 1.0-8 .3 ) .
RESULTS	However , the effect was not apparent for patients in the middle tertile ( OR = 1.6 , 95 % CI = 0.8-3 .6 ) or lower tertile of glucose ( OR = 1.1 , 95 % CI = 0.5-2 .6 ) .
RESULTS	Uric acid therapy was more effective than placebo in limiting infarct growth in the upper tertile range ( Mann-Whitney U test , p = 0.04 ) but not in the middle tertile ( p = 0.95 ) or lower tertile of glucose ( p = 0.30 ) .
RESULTS	Uric acid also proved superior to placebo in reducing infarct growth in patients with early recanalization .
CONCLUSIONS	Uric acid therapy was associated with reduced infarct growth and improved outcome in patients with hyperglycemia during acute stroke .

###24424425
BACKGROUND	Cocaine pharmacotherapy trials are often confounded by considerable variability in baseline cocaine-use levels , obscuring possible medication efficacy .
BACKGROUND	Testing the feasibility of using a prerandomization , abstinence-induction protocol , we screened three candidate medications to explore treatment response in patients who did , or did not , achieve abstinence during an extended baseline phase .
METHODS	Eligible treatment-seeking , cocaine-dependent subjects entered a 4-week baseline period ( Phase I ) with high-value abstinence contingent vouchers and two motivational interviewing sessions , followed by a 12-week medication trial ( Phase II ) with random assignment stratified on Phase I abstinence status to ( 1 ) modafinil ( 400mg/d ) , ( 2 ) levodopa/carbidopa ( 800/200mg/d ) , ( 3 ) naltrexone ( 50mg/d ) , or ( 4 ) placebo .
METHODS	Treatment consisted of thrice-weekly clinic visits for urine benzoylecgonine testing and weekly cognitive behavioral therapy with contingency management targeting medication compliance .
RESULTS	Of the 118 subjects enrolled , 81 ( 80 % ) completed Phase I , with 33 ( 41 % ) achieving abstinence , defined a priori as 6 consecutive cocaine-negative urines .
RESULTS	Tests of the interaction of each medication ( active versus placebo ) by baseline status ( abstinent versus nonabstinent ) permitted moderator effect analysis .
RESULTS	Overall , baseline abstinence predicted better outcome .
RESULTS	Cocaine-use outcomes for levodopa and naltrexone treatment differed as a function of Phase I abstinence status , with both medications producing benefit in nonabstinent but not baseline-abstinent subjects .
RESULTS	There was no evidence of a moderator effect for modafinil .
CONCLUSIONS	The two-phase screening trial demonstrated that subgrouping of patients with respect to baseline abstinence status is feasible and clinically useful for exploring cocaine cessation and relapse-prevention effects of candidate medications .

###25406682
BACKGROUND	Prevention of new IgE sensitizations has been described during allergen-specific immunotherapy .
BACKGROUND	However , prospective data using a preventive approach in very young children who would benefit most are missing .
BACKGROUND	We initiated a prospective pilot study investigating the safety , immunomodulatory , and sensitization-preventive effect of sublingual immunotherapy ( SLIT ) in mono/oligoclonally sensitized , clinically asymptomatic children 2-5 yr of age .
METHODS	In this double-blinded , randomized , placebo-controlled pilot study , 31 mono - / oligosensitized children to house-dust mite or grass pollen were included .
METHODS	SLIT with the respective source ( n = 15 ) or placebo ( n = 16 ) was applied .
METHODS	After dose-up-phase therapy was continued for 2 yr .
METHODS	Parents recorded clinical events , vaccinations , and drug intake in a diary .
METHODS	Skin prick testing and specific IgE and IgG measurements were recorded at baseline , 12 and 24 months .
METHODS	At the same time , allergen-specific proliferation and IL10 - and TGF-dependent Treg function were measured .
RESULTS	Preventive application of SLIT in young children was safe ( no relevant side effects in 21,170 single applications ) .
RESULTS	After 12 and 24 months of treatment , the rate of allergen-specific sensitization ( specific IgE and SPT reactivity ) was comparable in the treatment and the placebo group .
RESULTS	However , verum-treated patients displayed a significant up-regulation of allergen-specific IgG ( p < 0.05 ) .
RESULTS	Furthermore , IL10-dependent inhibition ( p < 0.05 ) was observed in vitro in the treatment group but not in the placebo group .
CONCLUSIONS	Preventive SLIT is safe in children 2-5 yr of age and induces regulatory mechanisms involving allergen-specific IgG and IL10 .
CONCLUSIONS	Based on this pilot study , large-scale trials will need to investigate the modulation of sensitization and clinically relevant allergy .

###24726004
BACKGROUND	Radiofrequency ablation ( RFA ) is associated with an excellent outcome in the treatment of great saphenous vein ( GSV ) incompetence .
BACKGROUND	The use of thermal energy as a treatment source requires the instillation of tumescence anesthesia .
BACKGROUND	Mechanochemical endovenous ablation ( MOCA ) combines mechanical endothelial damage , using a rotating wire , with the infusion of a liquid sclerosant .
BACKGROUND	Tumescence anesthesia is not required .
BACKGROUND	Preliminary experiences with MOCA showed good results and low post-procedural pain .
METHODS	The MARADONA ( Mechanochemical endovenous Ablation versus RADiOfrequeNcy Ablation ) trial is a multicenter randomized controlled trial in which 460 patients will be randomly allocated to MOCA or RFA .
METHODS	All patients with primary GSV incompetence who meet the eligibility criteria will be invited to participate in this trial .
METHODS	The primary endpoints are anatomic and clinical success at a one-year follow-up , and post-procedural pain .
METHODS	The secondary endpoints are technical success , complications , operation time , procedural pain , disease-specific quality of life , time taken to return to daily activities and/or work , and cost-efficiency analyses after RFA or MOCA .
METHODS	Both groups will be evaluated on an intention to treat base .
CONCLUSIONS	The MARADONA trial is designed to show equal results in anatomic and clinical success after one year , comparing MOCA with RFA .
CONCLUSIONS	In our hypothesis MOCA has an equal anatomic and clinical success compared with RFA , with less post-procedural pain .
BACKGROUND	Clinicaltrials NCT01936168 .

###25081937
BACKGROUND	Postoperative pain is an unavoidable consequence of open abdominal surgery .
BACKGROUND	Although cryotherapy , the application of ice to a surgical wound site , has been shown to be effective in reducing postoperative pain in orthopaedic , gynecologic , and hernia operations , it has not been assessed in patients who undergo major open abdominal operations .
BACKGROUND	We hypothesized that patients who receive cryotherapy would report lower pain scores as a primary outcomes measure .
METHODS	Patients undergoing abdominal operations with midline incisions were randomized to receive cryotherapy for a minimum of 24 hours in time intervals dictated by patient preference vs no cryotherapy .
METHODS	The primary outcome of pain relief was assessed with visual analog pain scores ( VAS ) .
METHODS	The study was powered to detect a clinically significant difference in VAS between the control and cryotherapy group .
METHODS	Comparisons between groups were measured by Student 's t-test or Mann-Whitney U test for parametric and nonparametric data , respectively .
RESULTS	There were 55 patients randomized : 28 to the control group and 27 to the cryotherapy group .
RESULTS	For the primary measure , mean postoperative pain score on postoperative days ( PODs ) 1 and 3 after surgery was significantly lower between the control and cryotherapy groups on the visual analog pain scale ( p < 0.005 ) .
RESULTS	Narcotic use was decreased in the cryotherapy group on POD 1 by 3.9 morphine equivalents ( p = 0.008 ) .
RESULTS	No statistically significant difference was found between the 2 treatment groups with respect to length of hospital stay , pulmonary complications , and wound infection rate in terms of secondary measures .
CONCLUSIONS	Ice packs are a simple , cost-effective adjuvant for decreasing postoperative pain and narcotic use in patients undergoing major abdominal operations .

###25015368
BACKGROUND	Cognitive behavior therapy for psychosis has been a prominent intervention in the psychological treatment of psychosis .
BACKGROUND	It is , however , a challenging therapy to deliver and , in the context of increasingly rigorous trials , recent reviews have tempered initial enthusiasm about its effectiveness in improving clinical outcomes .
BACKGROUND	Acceptance and commitment therapy shows promise as a briefer , more easily implemented therapy but has not yet been rigorously evaluated in the context of psychosis .
BACKGROUND	The purpose of this trial is to evaluate whether Acceptance and Commitment Therapy could reduce the distress and disability associated with psychotic symptoms in a sample of community-residing patients with chronic medication-resistant symptoms .
METHODS	This is a single ( rater ) - blind multi-centre randomised controlled trial comparing Acceptance and Commitment Therapy with an active comparison condition , Befriending .
METHODS	Eligible participants have current residual hallucinations or delusions with associated distress or disability which have been present continuously over the past six months despite therapeutic doses of antipsychotic medication .
METHODS	Following baseline assessment , participants are randomly allocated to treatment condition with blinded , post-treatment assessments conducted at the end of treatment and at 6 months follow-up .
METHODS	The primary outcome is overall mental state as measured using the Positive and Negative Syndrome Scale .
METHODS	Secondary outcomes include preoccupation , conviction , distress and disruption to life associated with symptoms as measured by the Psychotic Symptom Rating Scales , as well as social functioning and service utilisation .
METHODS	The main analyses will be by intention-to-treat using mixed-model repeated measures with non-parametric methods employed if required .
METHODS	The model of change underpinning ACT will be tested using mediation analyses .
CONCLUSIONS	This protocol describes the first randomised controlled trial of Acceptance and commitment therapy in chronic medication-resistant psychosis with an active comparison condition .
CONCLUSIONS	The rigor of the design will provide an important test of its action and efficacy in this population .
BACKGROUND	Australian New Zealand Clinical Trials Registry : ACTRN12608000210370 .
BACKGROUND	Date registered : 18 April 2008 .

###24675915
OBJECTIVE	To evaluate the effectiveness of low-frequency TENS ( LFT ) and high-frequency TENS ( HFT ) in post-episiotomy pain relief .
METHODS	A randomized , controlled , double-blind clinical trial with placebo composed of 33 puerperae with post-episiotomy pain .
METHODS	TENS was applied for 30 minutes to groups : HFT ( 100 Hz ; 100 s ) , LFT ( 5 Hz ; 100 s ) , and placebo ( PT ) .
METHODS	Four electrodes were placed in parallel near the episiotomy and four pain evaluations were performed with the numeric rating scale .
METHODS	The first and the second evaluation took place before TENS application and immediately after its removal and were done in the resting position and in the activities of sitting and ambulating .
METHODS	The third and fourth evaluation took place 30 and 60 minutes after TENS removal , only in the resting position .
METHODS	Intragroup differences were verified using the Friedman and Wilcoxon tests , and the intergroup analysis employed the Kruskal-Wallis test .
RESULTS	In the intragroup analysis , there was no significant difference in the PT during rest , sitting , and ambulation ( P > 0.05 ) .
RESULTS	In the HFT and LFT , a significant difference was observed in all activities ( P < 0.001 ) .
RESULTS	In the intergroup analysis , there was a significant difference in the resting position in the HFT and LFT ( P < 0.001 ) .
RESULTS	In the sitting activity , a significant difference was verified in the second evaluation in the HFT and LFT ( P < 0.008 ) .
RESULTS	No significant difference was verified among the groups in ambulation ( P < 0.20 ) .
CONCLUSIONS	LFT and HFT are an effective resource that may be included in the routine of maternity wards .

###24296871
OBJECTIVE	To assess the clinical relevance ( functional outcome ) of a 3-month allopurinol regimen in patients with high serum uric acid ( SUA ) levels and acute ischemic stroke without considering the changes in SUA levels .
METHODS	In a randomized , double-blind , controlled study , 70 patients ( 45 females , 25 males ) with acute ischemic stroke who had elevated levels of SUA were included .
METHODS	They were divided in two 35-patient groups to investigate the effect of 3 months of an allopurinol ( 200 mg/day ) regimen versus placebo on their functional outcome , which was evaluated using a modified Rankin scale .
RESULTS	The overall mean age was 68.9 11.33 years ( range 27-89 ) .
RESULTS	The final favorable functional status ( mRS = 0-2 ) was 23 ( 65.7 % ) and 14 ( 40.0 % ) in the treated and placebo groups , respectively , which was strongly associated with allopurinol consumption ( OR = 4.646 , p = 0.014 ) and age 70 years ( OR = 0.139 , p = 0.005 ) in patients with ischemic stroke after adjusting for confounders .
RESULTS	There was no significant difference in death between allopurinol-treated cases ( 3 ; 8.6 % ) and placebo-treated ones ( 6 ; 17.2 % ; p = 0.278 ) .
CONCLUSIONS	Allopurinol treatment was well tolerated and improved the 3-month functional status of patients with acute ischemic stroke who had high levels of SUA without considering the decreasing effect of allopurinol on SUA .

###25272531
OBJECTIVE	To compare new onset dyslipidaemia in live-related renal transplant recipients taking cyclosporine versus tacrolimus after 3 months of therapy .
METHODS	The randomised controlled trial was conducted at the Sindh Institute of Urology and Transplantation ( SIUT ) Karachi , from September 2010 to April 2011 , and included 182 End Stage Renal Disease patients on maintenance haemodialysis with pre-transplant normal lipid profile .
METHODS	The patients , who had live-related renal transplant , were randomly allocated to two equal groups using lottery .
METHODS	Group A received cyclosporine ( 3 mg/kg ) and group B was treated with tacrolimus ( 0.1 mg/kg ) .
METHODS	All patients had pre-transplant fasting lipid profile checked when they were on maintenance haemodialysis and 3 months after renal transplantation .
METHODS	Serum fasting lipid profile was collected by taking 5 ml blood by venipuncture after an overnight fast of 9-12 hours .
METHODS	SPSS 10 was used for statistical analyses .
RESULTS	Of the 182 patients , 144 ( 79.1 % ) were males and 38 ( 20.9 % ) were females .
RESULTS	The overall mean age was 30.18 + / - 9.57 years , and the mean weight was 54.41 + / - 11.144 kg .
RESULTS	Significant difference was not observed between the two groups regarding age and weight of the patients .
RESULTS	Dyslipidaemia was found in 115 ( 63.2 % ) subjects ; 61 ( 67 % ) in group A and 54 ( 59.3 % ) in group B.
RESULTS	There was no statistical difference ( p = 0.28 ) when comparison was done after 3 months of therapy .
CONCLUSIONS	The occurrence of new onset hyperlipidaemia is similar in renal transplant recipients receiving either cyclosporine or tacrolimus in first 3 months post-transplant , but there is room for more research in this field as dyslipidaemia following successful renal transplantation is a frequent and persistent complication .

###24675245
OBJECTIVE	Postoperative ileus has been considered an inevitable consequence of abdominal surgery .
OBJECTIVE	The aim of the study was to investigate the efficacy of same treatments in resolving postoperative ileus in various surgical approaches .
METHODS	A total of 360 patients underwent abdominal surgery , and was divided into four groups : videolaparoscopic cholecystectomy , laparotomic colo-rectal surgery , laparotomic Hartmann procedure , laparotomic gastric surgery .
METHODS	In each group , patients received different postoperative treatments : chewing gum , olive oil , both , and water .
METHODS	Each group was compared with a control group .
RESULTS	In patients who underwent videolaparoscopic cholecystectomy , median postoperative first passage of flatus and stool in the water group was 10 and 34 hours , respectively ( P = 0.006 , P = 0.021 ) and significantly earlier than in the control group ( median postoperative 24 and 72 hours ) .
RESULTS	Postoperative stay for the water group was lower ( median day 1 , 3rd interquartile 2.5 ) compared with control ( median day 3 ; 3rd interquartile 7.0 , P = 0.01 ) .
RESULTS	In patients who underwent gastric surgery , median postoperative first passage of stool in the olive oil and chewing gum group was 48 hours , significantly earlier than in the control ( median postoperative hour 120 , P = 0.04 ) .
RESULTS	Median time to first passage of flatus and stool was also earlier in the other groups compared with the control group , though this difference was not significant .
CONCLUSIONS	Chewing gum , olive oil or both do not induce a relevant reduction of ileus after surgery .
CONCLUSIONS	Water may be a safe and inexpensive option in reducing ileus .
CONCLUSIONS	( United States National Institutes of Health , www.clinicaltrial.gov , number NCT01869231 ) .

###25511814
BACKGROUND	Calcium needs are physiologically upregulated during pregnancy and lactation to meet demands of the developing fetus and breastfeeding infant .
BACKGROUND	Maternal calcium homeostasis is maintained by hormonal adaptive mechanisms , thus , the role of dietary calcium supplementation in altering maternal responses to fetal-infant demand for calcium is thought to be limited .
BACKGROUND	However , increased calcium absorption is directly related to maternal calcium intake and dietary supplementation has been suggested to prevent transient bone loss associated with childbearing .
METHODS	In a double-blind , randomized placebo-controlled trial , we randomly assigned 670 women in their first trimester of pregnancy to 1,200 mg/day calcium ( N = 334 ) or placebo ( N = 336 ) .
METHODS	Subjects were followed through 1-month postpartum and the effect on urinary cross-linked N-telopeptides ( NTx ) of type I collagen , a specific marker of bone resorption , was evaluated using an intent-to-treat analysis .
METHODS	Women with a baseline and at least one follow-up measurement ( N = 563 ; 84 % ) were included .
METHODS	Subsequent analyses were conducted stratifying subjects by compliance assessed using pill counts .
METHODS	In random subsets of participants , bone-specific alkaline phosphatase ( BAP ) ( N = 100 ) and quantitative ultrasound ( QUS ) ( N = 290 ) were also measured .
RESULTS	Calcium was associated with an overall reduction of 15.8 % in urinary NTx relative to placebo ( p < 0.001 ) .
RESULTS	Among those who consumed 50 % , 67 % , and 75 % of pills , respectively , the effect was associated with 17.3 % , 21.3 % , and 22.1 % reductions in bone resorption ( all p < 0.001 ) .
RESULTS	There was no significant effect of calcium on bone formation measured by BAP .
RESULTS	However , by 1-month postpartum , those in the calcium group had significantly lower NTx/BAP ratios than those in the placebo group ( p = 0.04 ) indicating a net reduction in bone loss in the supplement group by the end of follow-up .
RESULTS	Among subjects who consumed 50 % and 75 % of pills , respectively , calcium was also associated with an increase of 26.3 m/s ( p = 0.03 ) and 59.0 m/s ( p = 0.009 ) in radial SOS relative to placebo by 1-month postpartum .
CONCLUSIONS	Calcium administered during pregnancy and the early postpartum period , to women with intakes around adequacy , was associated with reduced bone resorption and , thus , may constitute a practical intervention to prevent transient skeletal loss associated with childbearing .
BACKGROUND	ClinicalTrials.gov Identifier NCT00558623 .

###25487930
OBJECTIVE	The aim of this study was to investigate clinical application of remifentanil in local anesthesia for resection of tumors in functional brain area .
METHODS	Twenty-four patients were randomly divided into two groups : control group and remifentanil group .
METHODS	In remifentanil group remifentanil was infused intravenously with micro pump in 0.05-0 .1 gkg-1min-1 .
METHODS	The hemodynamic changes and complications during operation were monitored .
RESULTS	The satisfactory degree for surgical procedure was evaluated .
RESULTS	The surgery of two groups could be completed in a conscious state .
RESULTS	Mean artery pressure ( MAP ) , heart rate ( HR ) in remifentanil group during opening or closing skull or intra - cranial period were significantly lower than control group ( p < 0.05 ) .
RESULTS	There were no conspicuous complications in two groups such as respiratory depression , nausea , vomitting and dysphoria .
RESULTS	Satisfaction rate of remifentanyl group was significantly higher than control group ( p < 0.05 ) .
CONCLUSIONS	Awake brain tumor surgery could be completed in rational use of remifentanil on the base of good local anesthesia , and hemodynamics were stable and the patients were well tolerated .

###24256083
OBJECTIVE	Brivaracetam ( BRV ) is a novel high-affinity synaptic vesicle protein 2A ligand in clinical development for the treatment of epilepsy .
OBJECTIVE	This phase III study ( N01252 ; NCT00490035 ) evaluated the efficacy and safety/tolerability of BRV ( 20 , 50 , and 100 mg/day ) compared with placebo ( PBO ) in patients aged 16-70 years with uncontrolled focal seizures with/without secondary generalization , despite treatment with one to two concomitant antiepileptic drugs at a stable and optimal dosage .
METHODS	This was a double-blind , randomized , placebo-controlled trial conducted across Europe and India .
METHODS	Eligible patients had two or more focal seizures/month for 3 months prior to screening and eight or more focal seizures during the 8-week prospective baseline .
METHODS	Concomitant use of levetiracetam was limited to 20 % of randomized patients .
METHODS	Patients were randomized ( 1:1:1:1 ) to BRV 20 , 50 , 100 mg/day or PBO with no up-titration for 12 weeks , followed by down-titration or entry into a long-term follow-up study .
METHODS	The primary efficacy end point was percent reduction over PBO in baseline-adjusted focal seizure frequency/week over the 12-week treatment period .
METHODS	Comparison of BRV with PBO was sequential to control for multiplicity ( 50 , 100 , 20 mg/day ) , and thus required BRV to demonstrate superiority over PBO at 50 mg/day to meet the primary efficacy end point .
METHODS	Secondary efficacy variables were median percent reduction from baseline in focal seizure frequency/week , 50 % responder rate , and seizure freedom ( all seizure types ) .
METHODS	Safety assessments included treatment-emergent adverse events ( TEAEs ) .
RESULTS	Of 399 randomized patients , 398 were included in the intent-to-treat ( ITT ) and safety populations .
RESULTS	Overall , 367 ( 92.2 % ) of 398 patients completed the study ( BRV : 93.9 % , 88.9 % , and 94.0 % for 20 , 50 , and 100 mg/day , respectively ; PBO : 92.0 % ) and 345 ( 86.7 % ) of 398 patients continued into long-term follow-up studies ( BRV : 87.9 % , 82.8 % , and 88.0 % for 20 , 50 , and 100 mg/day , respectively ; PBO : 88.0 % ) .
RESULTS	The study did not meet its primary efficacy end point based on the predefined sequential testing strategy .
RESULTS	Indeed , percent reduction over PBO in baseline-adjusted focal seizure frequency/week ( primary efficacy analysis ) was 6.8 % ( p = 0.239 ) , 6.5 % ( p = 0.261 ) , and 11.7 % ( p = 0.037 ) for BRV 20 , 50 , and 100 mg/day , respectively .
RESULTS	Median percent reduction from baseline in focal seizure frequency/week was 30.0 % ( p = 0.019 ) , 26.8 % ( p = 0.092 ) , and 32.5 % ( p = 0.004 ) for BRV 20 , 50 , and 100 mg/day , respectively , compared with 17.0 % for PBO .
RESULTS	Responder rates ( 50 % ) were 27.3 % ( p = 0.339 ) , 27.3 % ( p = 0.372 ) , and 36.0 % ( p = 0.023 ) for BRV 20 , 50 , and 100 mg/day , respectively , compared with 20.0 % for PBO .
RESULTS	Complete seizure freedom was reported by 2/99 , 0/99 , and 4/100 patients on BRV 20 , 50 , and 100 mg/day , respectively , compared with 0/100 on PBO .
RESULTS	The incidence of TEAEs was higher for BRV 20 ( 56/99 , 56.6 % ) , 50 ( 62/99 , 62.6 % ) , and 100 mg/day ( 63/100 , 63.0 % ) than PBO ( 53/100 , 53.0 % ) ; most TEAEs were mild or moderate in severity .
RESULTS	The most frequently reported TEAEs in the BRV groups were headache , somnolence , dizziness , and fatigue .
CONCLUSIONS	In this study of adjunctive BRV ( 20-100 mg/day ) in adults with uncontrolled focal seizures , the primary efficacy analysis based on the 50 mg/day dose was not statistically significant .
CONCLUSIONS	However , BRV 100 mg/day reduced baseline-adjusted focal seizure frequency/week by 11.7 % over PBO , achieving statistical significance ( p = 0.037 ) .
CONCLUSIONS	Secondary efficacy analyses ( percent reduction from baseline in focal seizure frequency/week , 50 % responder rate ) provided supportive evidence for the efficacy of BRV 100 mg/day .
CONCLUSIONS	BRV 20-100 mg/day was well tolerated without up-titration , with a high completion rate .

###24327590
OBJECTIVE	Medication errors related to hospital discharge result in rehospitalization and emergency department ( ED ) visits , yet no systematic approach has been implemented nationally to decrease these medication errors .
OBJECTIVE	Pharmacist involvement during postdischarge transitions of care may be an important strategy to prevent and correct medication discrepancies and reduce costly rehospitalization and ED visits .
METHODS	This prospective , randomized , open-label , pilot study evaluated the effect of a pharmacy clinic visit focused on medication reconciliation and patient education after hospital discharge on the incidence of rehospitalization and ED visits and the resolution of medication discrepancies .
RESULTS	Of the 61 subjects included in the study , 33 ( 54 % ) had medication discrepancies identified at discharge .
RESULTS	Fifty percent of medication discrepancies were resolved in subjects randomized to the pharmacist intervention arm compared with 9.5 % in the usual care arm ( P = .015 ) .
RESULTS	Patients randomized to the intervention arm had significantly lower rates of the primary composite outcome of 30-day rehospitalization and ED visits compared with the usual care arm ( 0 % vs 40.5 % , P < .001 ) .
CONCLUSIONS	A pharmacist-driven intervention focused on patient education and medication reconciliation after discharge improved medication use and reduced health care resource utilization in this pilot study .

###25539779
OBJECTIVE	Prostate-specific antigen ( PSA ) screening is controversial .
OBJECTIVE	A community jury allows presentation of complex information and may clarify how participants view screening after being well-informed .
OBJECTIVE	We examined whether participating in a community jury had an effect on men 's knowledge about and their intention to participate in PSA screening .
METHODS	Random allocation to either a 2-day community jury or a control group , with preassessment , postassessment and 3-month follow-up assessment .
METHODS	Participants from the Gold Coast ( Australia ) recruited via radio , newspaper and community meetings .
METHODS	Twenty-six men aged 50-70 years with no previous diagnosis of prostate cancer .
METHODS	The control group ( n = 14 ) received factsheets on PSA screening .
METHODS	Community jury participants ( n = 12 ) received the same factsheets and further information about screening for prostate cancer .
METHODS	In addition , three experts presented information on PSA screening : a neutral scientific advisor provided background information , one expert emphasised the potential benefits of screening and another expert emphasised the potential harms .
METHODS	Participants discussed information , asked questions to the experts and deliberated on personal and policy decisions .
METHODS	Our primary outcome was change in individual intention to have a PSA screening test .
METHODS	We also assessed knowledge about screening for prostate cancer .
RESULTS	Analyses were conducted using intention-to-treat .
RESULTS	Immediately after the jury , the community jury group had less intention-to-screen for prostate cancer than men in the control group ( effect size = -0.6 SD , p = 0.05 ) .
RESULTS	This was sustained at 3-month follow-up .
RESULTS	Community jury men also correctly identified PSA test accuracy and considered themselves more informed ( effect size = 1.2 SD , p < 0.001 ) .
CONCLUSIONS	Evidence-informed deliberation of the harms and benefits of PSA screening effects men 's individual choice to be screened for prostate cancer .
CONCLUSIONS	Community juries may be a valid method for eliciting target group input to policy decisions .
BACKGROUND	Australian and New Zealand Clinical Trials Registry ( ACTRN12612001079831 ) .

###25031312
BACKGROUND	Mobile-phone-based text ( SMS ) messaging is an effective method for delivering smoking cessation assistance ; however , little is known about optimal program use .
BACKGROUND	This paper reports on the use of 2 forms of interaction ( reporting changes in quit status and emergency help ) among users of QuitTxt , an interactive , automated text messaging advice program .
BACKGROUND	We examined preferences for messaging intensity , duration of use , and their associations with short-term cessation outcome or perceived helpfulness .
METHODS	QuitTxt was offered during participation in a previously reported randomized controlled trial and was activated by 924 smokers or recent quitters , of whom 862 used it to a criterion level .
METHODS	Outcome data ( quit attempts , 7-day point prevalence abstinence , and perceived helpfulness ) were collected 1 month after first use .
RESULTS	Most ( 68.9 % ) accepted the default of 4-8 messages per day , and median use duration was 27 days .
RESULTS	Half ( 49.1 % ) appeared to miss reporting at least 1 status change , with relapses less likely to be reported than quit progression .
RESULTS	Emergency help was used by 27.0 % of those eligible for it ; emergency help was used more frequently among those with recent quit experience and lower nicotine dependence .
RESULTS	Use of emergency help was unrelated to short-term cessation outcome .
CONCLUSIONS	The most notable finding is the variability in use .
CONCLUSIONS	Some users complied fully with the requirement to report status changes , while even among those who did not , many found QuitTxt to be very helpful , suggesting that perfect congruence between message content and quit status is not essential .
CONCLUSIONS	The use of emergency help functionality was relatively rare but was appreciated .

###24760261
OBJECTIVE	To test whether a weight loss program promotes greater weight loss , glycemic control , and improved cardiovascular disease risk factors compared with control conditions and whether there is a differential response to higher versus lower carbohydrate intake .
METHODS	This randomized controlled trial at two university medical centers enrolled 227 overweight or obese adults with type 2 diabetes and assigned them to parallel in-person diet and exercise counseling , with prepackaged foods in a planned menu during the initial phase , or to usual care ( UC ; two weight loss counseling sessions and monthly contacts ) .
RESULTS	Relative weight loss was 7.4 % ( 95 % CI 5.7-9 .2 % ) , 9.0 % ( 7.1-10 .9 % ) , and 2.5 % ( 1.3-3 .8 % ) for the lower fat , lower carbohydrate , and UC groups ( P < 0.001 intervention effect ) .
RESULTS	Glycemic control markers and triglyceride levels were lower in the intervention groups compared with UC group at 1 year ( fasting glucose 141 [ 95 % CI 133-149 ] vs. 159 [ 144-174 ] mg/dL , P = 0.023 ; hemoglobin A1c 6.9 % [ 6.6-7 .1 % ] vs. 7.5 % [ 7.1-7 .9 % ] or 52 [ 49-54 ] vs. 58 [ 54-63 ] mmol/mol , P = 0.001 ; triglycerides 148 [ 134-163 ] vs. 204 [ 173-234 ] mg/dL , P < 0.001 ) .
RESULTS	The lower versus higher carbohydrate groups maintained lower hemoglobin A1c ( 6.6 % [ 95 % CI 6.3-6 .8 % ] vs. 7.2 % [ 6.8-7 .5 % ] or 49 [ 45-51 ] vs. 55 [ 51-58 ] mmol/mol ) at 1 year ( P = 0.008 ) .
CONCLUSIONS	The weight loss program resulted in greater weight loss and improved glycemic control in type 2 diabetes .

###24405979
BACKGROUND	Recurrent miscarriage is a major women 's health problem .
BACKGROUND	Aspirin and heparin have been shown to have potentially beneficial effects on trophoblast implantation .
BACKGROUND	However , few published data on this issue are available from developing countries .
METHODS	An open clinical trial was conducted at the Department of Obstetrics and Gynecology at Misurata Teaching Hospital in Libya from January 2009 to December 2010 to investigate the effects of treatment with low dose aspirin ( LDA ) versus treatment with low-molecular-weight-heparin ( LMWH ) in combination with LDA on patients with a history of recurrent miscarriages .
METHODS	A total of 150 women were enrolled in the study .
METHODS	Women were eligible for the study if they had a history of three or more consecutive miscarriages .
METHODS	Participants were randomly assigned to receive either LDA ( 75 mg daily ) alone or a combination of LDA and LMWH ( 75 women per treatment group ) .
METHODS	The primary outcomes were the rate of miscarriages and live births for each group .
RESULTS	Compared with the group who received LDA alone , the combination group had a significantly lower number of miscarriages ( 22/75 [ 29 % ] vs. 43/75 [ 47 % ] , P < 0.001 ) and had a significantly higher number of live births ( 53/75 [ 71 % ] vs. 32/75 [ 42 % ] , P < 0.001 ) .
RESULTS	Two preterm infants in the LDA group and three in the combination group were admitted to the neonatal intensive care unit .
RESULTS	There were no significant differences in the mean ( SD ) birth weights of neonates born in either group ( 2955.4 560 vs. 3050 540 g for the LDA and combination groups , respectively , P = 0.444 ) .
RESULTS	There were no congenital abnormalities detected in either group .
CONCLUSIONS	The combination of LDA and LMWH is better than LDA alone for the maintenance of pregnancy in patients with recurrent first trimester miscarriage .
BACKGROUND	NCT01917799 .

###25267694
OBJECTIVE	Because heart rate affects ventricular filling , the aim of the present study was to assess the effects of increasing heart rate and tidal volume on stroke volume variability to determine whether this dynamic index is heart-rate dependent .
METHODS	Prospective , randomized study .
METHODS	Single university hospital .
METHODS	Eighteen vascular surgery patients having general anesthesia and endotracheal intubation with an arterial catheter connected to the Vigileo FloTrac system ( Edwards Lifesciences , Irvine , CA ) and a transesophageal atrial pacemaker ( CardioComman Inc , Tampa , FL ) .
METHODS	A 2 2 factorial study of changes in heart rate ( 80 bpm and 110 bpm ) and tidal volume ( 6 mL/kg and 10 mL/kg ) .
RESULTS	With tidal volume at 6 mL/kg , increasing heart rate from 80 mL/kg to 110 bpm caused stroke volume variability to increase from 12.2 % 5.7 % to 13.2 % 5.3 % ( p < 0.05 ) , and with tidal volume at 10 mL/kg , increasing heart rate from 80 mL/kg to 110 bpm caused stroke volume variability to increase from 19.7 % 7.9 % to 22.0 % 8.6 % ( p < 0.05 ) .
RESULTS	In comparison , increasing tidal volume from 6 mL/kg to 10 mL/kg produced a significantly greater effect on stroke volume variability than increasing heart rate .
CONCLUSIONS	Stroke volume variability is sensitive to increases in heart rate in addition to tidal volume .
CONCLUSIONS	Increasing heart rate caused stroke volume variability to increase significantly , although not to the same magnitude as increasing tidal volume .
CONCLUSIONS	When using dynamic volume indices , clinicians should be aware of increases in heart rate , although its clinical impact may be relatively minor compared with changes in tidal volume .

###25081290
OBJECTIVE	To determine the effect of oral acetazolamide on lowering the peak and duration of intraocular pressure ( IOP ) rise in glaucoma and glaucoma suspect patients , following intravitreal injection of ranibizumab for neovascular age-related macular degeneration .
METHODS	The study was an open-label , parallel , randomised , controlled trial ( EudraCT Number : 2010-023037-35 ) .
METHODS	Twenty-four glaucoma or glaucoma suspect patients received either 500mg acetazolamide or no treatment 60-90min before 0.5 mg ranibizumab .
METHODS	The primary outcome measure was the difference in IOP immediately after injection ( T0 ) and 5 , 10 , and 30min following injection .
METHODS	ANCOVA was used to compare groups , adjusting for baseline IOP .
METHODS	The study was powered to detect a 9-mmHg difference at T0 .
RESULTS	The IOP at T0 was 2.3 mmHg higher in the non-treated group ( mean 44.5 mmHg , range ( 19-86mmHg ) ) compared with the treated group ( mean 42.2 mmHg , range ( 25-58mmHg ) ) , but was not statistically significant after adjusting for baseline IOP ( P = 0.440 ) .
RESULTS	At 30min , IOP was 4.9 mmHg higher in the non-treated group ( mean 20.6 mmHg , range ( 11-46mmHg ) ) compared with the treated group ( mean 15.7 mmHg , range ( 8-21mmHg ) ) .
RESULTS	This was statistically significant after adjusting for baseline IOP ( P = 0.013 ) .
CONCLUSIONS	Although the primary end points were not reached , 500mg oral acetazolamide , 60-90min before intravitreal injection , results in a statistically significant reduction in IOP at 3O min post injection .
CONCLUSIONS	Prophylactic treatment may be considered as an option to minimise neuro-retinal rim damage in high-risk glaucoma patients who are most vulnerable to IOP spikes and undergoing repeated intravitreal injections of ranibizumab .

###25031529
OBJECTIVE	The effects of an anticholinergic or antidiuretic agent as add-on therapy to an alpha-blocker for lower urinary tract symptoms ( LUTS ) according to a voiding diary in 3 days are unknown .
OBJECTIVE	We prospectively investigated the efficacy of an anticholinergic or antidiuretic agent as add-on therapy for nocturia in men previously treated with an alpha-blocker for LUTS .
METHODS	Patients were randomly subdivided into two groups .
METHODS	All patients had a 4-week washout .
METHODS	Group A had alpha-blocker for 4 weeks , then an alpha-blocker plus an anticholinergic agent for 4 weeks , and , finally , 4 weeks of an alpha-blocker plus an antidiuretic agent .
METHODS	Group B had an alpha-blocker for 4 weeks , then an alpha-blocker plus an antidiuretic agent for 4 weeks , and , finally , 4 weeks of an alpha-blocker plus an anticholinergic agent .
METHODS	In both groups , patients were subdivided into nocturnal polyuria , decreased nocturnal bladder capacity ( NBC ) , or nocturia by both causes subgroups .
METHODS	A 3-day voiding diary , total International Prostate Symptom Score ( IPSS ) , IPSS sub-scores , Overactive Bladder Symptom Score , uroflowmetry , and post-void residual urine volume , were assessed at baseline , and at 4 , 8 , and 12 weeks .
RESULTS	A total of 405 patients completed the study .
RESULTS	During treatment , the changes from baseline in total IPSS and IPSS sub-scores were significantly decreased at 4 weeks and were maintained for 12 weeks .
RESULTS	In the nocturnal polyuria subgroup of Groups A and B , the number of episodes of nocturia in 3 days , nocturnal urine volume , and nocturnal index were significantly decreased using an alpha-blocker plus an antidiuretic agent .
RESULTS	In the decreased NBC subgroup of Groups A and B , IPSS storage sub-score , Overactive Bladder Symptom Score , number of episodes of nocturia in 3 days , number of episodes of urgency in 3 days , and NBC index were all significantly decreased using an alpha-blocker plus an anticholinergic agent .
CONCLUSIONS	An anticholinergic agent or antidiuretic agent as an add-on therapy in men previously treated with an alpha-blocker improves nocturia including LUTS .

###24279229
BACKGROUND	The negative effect of hypoxia on cognitive function has been well described .
BACKGROUND	However , less has been published regarding cognitive dysfunction resulting from hypoxia produced by exposure to different altitudes .
METHODS	We measured short-term and working memory capacity ( Digit Span tasks ) , cognitive flexibility and selective attention ( Word-Color Stroop Task ) , and executive functioning ( Trailmaking A and B tests ) at baseline and simulated altitudes equal to 17,500 ft ( 5334 m ) and 25,000 ft ( 7620 m ) in order to obtain more information about the role of altitude exposure on cognitive tasks important for optimal functioning in the aviation environment .
RESULTS	Behavioral observations indicated that hypoxia was induced at different simulated altitudes .
RESULTS	Marked declines in cognitive performance were also observed for all tests at 25,000 ft , with scores indicating greater impairment in this condition relative to others .
RESULTS	Subjects also showed greater impairment when scores obtained in the 17,500-ft condition were compared to baseline , although the effects were not as clearly defined relative to the 25,000 vs. baseline contrasts .
CONCLUSIONS	The results of this study suggest that electronic versions of these tests may be useful in screening for acute symptoms of hypoxia and could provide insight into how discrete cognitive processes become impaired with oxygen deprivation at various altitudes .
CONCLUSIONS	Given that these tests also assess neuropsychological functioning , our results allow for inferences to be made about the effects of hypoxia on human brain functioning .

###24854326
OBJECTIVE	Recent years have seen remarkable progress in cancer therapy , although treatment-induced adverse reactions and complications are not uncommon .
OBJECTIVE	Approximately 40 % of patients undergoing chemotherapy for cancer experience adverse reactions in the oral cavity , with nearly half of them developing severe oral mucositis that necessitates postponing therapy and/or changing the drug dosage .
OBJECTIVE	The objective of this study was to assess the usefulness of prophylactic professional oral health care ( POHC ) for preventing mucositis in patients undergoing chemotherapy .
METHODS	Twenty-six female patients scheduled for chemotherapy for breast cancer were included in this study and randomized to the self-care or POHC groups .
METHODS	Assessment parameters included oral cavity photographs , plaque control records , Saxon test scores , Oral Assessment Guide scores , and grading using the Common Terminology Criteria for Adverse Events .
METHODS	Beginning before surgery and continuing through the completion of chemotherapy , the POHC patient group received weekly professional oral health care , including scaling , professional cleaning of the tooth surfaces , brushing instructions , and nutritional and lifestyle guidance .
RESULTS	More patients in the self-care group developed oral mucositis than in the POHC group .
RESULTS	The Oral Assessment Guide score , which was used as an index of oral mucositis , was also significantly lower in the POHC group .
RESULTS	Based on the Oral Assessment Guide and plaque control records , there was almost no deterioration of the oral environment in the POHC group , whereas deterioration was observed in the self-care group .
CONCLUSIONS	These findings demonstrate the efficacy of regular POHC in reducing the risk of oral mucositis in breast cancer patients undergoing chemotherapy .

###24272023
OBJECTIVE	To compare the superficial incisional surgical site infection ( SSI ) rate after cesarean section ( CS ) in obese women using subcuticular versus interrupted skin suturing .
METHODS	The current randomized controlled clinical trial was conducted at Ain Shams University Maternity Hospital .
METHODS	Obese non-diabetic women who underwent elective CS were randomized into two groups : group I included women who had their skin closed with interrupted mattress suture using non-absorbable polypropylene , and group II included women who had their skin closed with subcuticular suture using the same suture material .
METHODS	Primary outcome measure was superficial incisional SSI and secondary outcome measures were skin closure time , postoperative pain assessed by ten-point visual analog scale ( VAS ) and short-term cosmetic wound outcome according to the Stony Brook Scar Evaluation Scale ( SBSES ) .
RESULTS	A total of 130 obese women were finally analyzed .
RESULTS	Group II ( n = 67 ) was associated with higher incidence of superficial incisional SSI .
RESULTS	There were nine cases ( 13.4 % ) compared to three cases ( 4.8 % ) in group I ( n = 63 ) ; however , this difference was statistically not significant ( P = 0.088 ) .
RESULTS	Skin closure time was significantly prolonged in group I ( 8.6 2.3 min versus 5.7 2.2 min , respectively , P < 0.001 ) .
RESULTS	Postoperative pain was significantly lower in group I and the mean VAS in group I was 4.7 2 versus 5.5 1.8 in group II ( P = 0.017 ) .
RESULTS	Using SBSES , group II had mean score 4.5 0.7 , while group I had mean score 2.7 1.1 .
RESULTS	This was statistically significant ( P < 0.001 ) , which means a better cosmetic outcome in group II .
CONCLUSIONS	Subcuticular skin closure during CS for non-diabetic obese women was significantly associated with better short-term cosmetic outcome , less skin closure time , yet , with slightly higher risk of superficial incisional SSI and significantly more postoperative pain .

###25230290
BACKGROUND	Adherence to pre-exposure prophylaxis ( PrEP ) is critical for efficacy .
BACKGROUND	Antiretroviral concentrations are an objective measure of PrEP use and correlate with efficacy .
BACKGROUND	Understanding patterns and correlates of drug detection can identify populations at risk for nonadherence and inform design of PrEP adherence interventions .
METHODS	Blood antiretroviral concentrations were assessed among active arm participants in iPrEx , a randomized placebo-controlled trial of emtricitabine/tenofovir in men who have sex with men and transgender women in 6 countries .
METHODS	We evaluated rates and correlates of drug detection among a random sample of 470 participants at week 8 and a longitudinal cohort of 303 participants through 72 weeks of follow-up .
RESULTS	Overall , 55 % of participants ( 95 % confidence interval : 49 to 60 ) tested at week 8 had drug detected .
RESULTS	Drug detection was associated with older age and varied by study site .
RESULTS	In longitudinal analysis , 31 % never had drug detected , 30 % always had drug detected , and 39 % had an inconsistent pattern .
RESULTS	Overall detection rates declined over time .
RESULTS	Drug detection at some or all visits was associated with older age , indices of sexual risk , including condomless receptive anal sex , and responding `` do n't know '' to a question about belief of PrEP efficacy ( 0-10 scale ) .
CONCLUSIONS	Distinct patterns of study product use were identified , with a significant proportion demonstrating no drug detection at any visit .
CONCLUSIONS	Research literacy may explain greater drug detection among populations having greater research experience , such as older men who have sex with men in the United States .
CONCLUSIONS	Greater drug detection among those reporting highest risk sexual practices is expected to increase the impact and cost-effectiveness of PrEP .

###24939671
BACKGROUND	In patients with chronic kidney disease ( CKD ) hyperuricemia is common .
BACKGROUND	Evidence that hyperuricemia might also play a causal role in vascular disease , hypertension and progression of CKD is accumulating .
BACKGROUND	Therefore , we studied the association between baseline uric acid ( UA ) levels and the rate of decline in renal function and time until start of dialysis in pre-dialysis patients .
METHODS	Data from the PREPARE-2 study were used .
METHODS	The PREPARE-2 study is an observational prospective cohort study including incident pre-dialysis patients with CKD stages IV-V in the years between 2004 and 2011 .
METHODS	Patients were followed for a median of 14.9 months until start of dialysis , kidney transplantation , death , or censoring .
METHODS	Main outcomes were the change in the rate of decline in renal function ( measured as estimated glomerular filtration rate ( eGFR ) ) estimated using linear mixed models , and time until start of dialysis estimated using Cox proportional hazards models .
RESULTS	In this analysis 131 patients were included with a baseline UA level ( mean ( standard deviation ( SD ) ) of 8.0 ( 1.79 ) mg/dl ) and a mean decline in renal function of -1.61 ( 95 % confidence interval ( CI ) , -2.01 ; -1.22 ) ml/min/1 .73 m2/year .
RESULTS	The change in decline in GFR associated with a unit increase in UA at baseline was -0.14 ( 95 % CI -0.61 ; 0.33 , p = 0.55 ) ml/min/1 .73 m2/year .
RESULTS	Adjusted for demography , comorbidities , diet , body mass index ( BMI ) , blood pressure , lipids , proteinuria , diuretic and/or allopurinol usage the change in decline in eGFR did not change .
RESULTS	The hazard ratio ( HR ) for starting dialysis for each mg/dl increase in UA at baseline was 1.08 ( 95 % CI , 0.94 ; 1.24 , p = 0.27 ) .
RESULTS	After adjustment for the same confounders the HR became significant at 1.26 ( 95 % CI , 1.06 ; 1.49 , p = 0.01 ) , indicating an earlier start of dialysis with higher levels of UA .
CONCLUSIONS	Although high UA levels are not associated with an accelerated decline in renal function , a high serum UA level in incident pre-dialysis patient is a risk factor for an earlier start of dialysis .

###25422027
BACKGROUND	A higher protein to carbohydrate ratio in the diet may potentiate weight loss , improve body composition and cardiometabolic risk , including glucose homeostasis in adults .
BACKGROUND	The aim of this randomised control trial was to determine the efficacy of two structured lifestyle interventions , differing in dietary macronutrient content , on insulin sensitivity and body composition in adolescents .
BACKGROUND	We hypothesised that a moderate-carbohydrate ( 40-45 % of energy ) , increased-protein ( 25-30 % ) diet would be more effective than a high-carbohydrate diet ( 55-60 % ) , moderate-protein ( 15 % ) diet in improving outcomes in obese , insulin resistant adolescents .
METHODS	Obese 10-17 year olds with either pre-diabetes and/or clinical features of insulin resistance were recruited at two hospitals in Sydney , Australia .
METHODS	At baseline adolescents were prescribed metformin and randomised to one of two energy restricted diets .
METHODS	The intervention included regular contact with the dietician and a supervised physical activity program .
METHODS	Outcomes included insulin sensitivity index measured by an oral glucose tolerance test and body composition measured by dual-energy x-ray absorptiometry at 12months .
RESULTS	Of the 111 adolescents recruited , 85 ( 77 % ) completed the intervention .
RESULTS	BMI expressed as a percentage of the 95th percentile decreased by 6.8 % [ 95 % CI : -8.8 to -4.9 ] , ISI increased by 0.2 [ 95 % CI : 0.06 to 0.39 ] and percent body fat decreased by 2.4 % [ 95 % CI : -3.4 to -1.3 ] .
RESULTS	There were no significant differences in outcomes between diet groups at any time .
CONCLUSIONS	When treated with metformin and an exercise program , a structured , reduced energy diet , which is either high-carbohydrate or moderate-carbohydrate with increased-protein , can achieve clinically significant improvements in obese adolescents at risk of type 2 diabetes .
BACKGROUND	Australian New Zealand Clinical Trail Registry ACTRN12608000416392 .
BACKGROUND	Registered 25 August 2008 .

###24885092
BACKGROUND	Oxidative stress and inflammation can be altered by dietary factors in various species .
BACKGROUND	However , little data are available in true carnivorous species such as domestic cats .
BACKGROUND	As numerous anti-inflammatory and anti-oxidative additives become available and might be of use in cats with chronic low-grade inflammatory diseases , the current study aimed to develop a model of diet-induced inflammation by use of two opposite diets .
BACKGROUND	It was hypothesized that a high fat diet enhanced in n-6 PUFA and with lower concentrations of antioxidants would evoke inflammation and oxidative stress in domestic cats .
RESULTS	Sixteen healthy adult cats were allocated to two groups .
RESULTS	One group received a moderate fat diet , containing pork lard and salmon oil ( AA : ( EPA+DHA ) ratio 0.19 ) ( MFn-3 ) , while the other group was fed a high fat diet , containing pork lard and chicken fat ( AA : ( EPA+DHA ) ratio 2.06 ) ( HFn-6 ) for 12weeks .
RESULTS	Prior to and 2 , 4 , 6 , 8 , 10 and 12weeks after starting the testing period , blood samples were collected .
RESULTS	Erythrocytic fatty acid profile showed clear alterations in accordance to the dietary fatty acid profile .
RESULTS	Serum thiobarbituric acid reactive substances was higher when fed MFn-3 compared to the HFn-6 , suggesting augmented oxidative stress .
RESULTS	This was associated with a reduced serum vitamin E status , as serum - tocopherol concentrations were lower with MFn-3 , even with higher dietary levels of vitamin E. Serum cytokine and serum amyloid A concentrations were not influenced by diet .
CONCLUSIONS	These results point towards a resistance of cats to develop dietary fat-induced inflammation , but also suggest a high susceptibility to oxidative stress when fed a fish oil-supplemented diet even with moderate fat level and additional vitamin E.

###25153706
BACKGROUND	It is still unknown how best to maintain effects of exercise programmes in COPD in the long-term .
BACKGROUND	We present the long-term effects of a community-based exercise programme incorporated in a self-management programme , compared to a self-management programme only in patients with COPD .
METHODS	All included patients participated in four self-management sessions .
METHODS	Additionally , patients in the intervention group participated in an 11-month community-based exercise programme led by physiotherapists .
METHODS	Patients trained three times/week for six months and two times/week during the subsequent five months .
METHODS	To encourage a behavioural change towards exercise , one of these weekly training sessions was home-based ( unsupervised ) .
METHODS	No formal exercise training was offered to intervention patients in the second year .
RESULTS	The intervention was assigned to 80 patients , and the control condition to 79 patients .
RESULTS	82.5 % and 78.5 % of the intervention and control group , respectively , completed 24 months follow-up .
RESULTS	Modified intention-to-treat analyses were performed .
RESULTS	Although statistically significant after 12 months ( 35.1 m ( 95 % CI : 8.4-61 .8 ) ) , the between-group difference on maximal exercise capacity was not statistically significant after 24 months ( 12.2 m ( 95 % CI : -16.6 to 41.0 ) .
RESULTS	Nevertheless , the between-group difference in daily physical activity was maintained after 24 months ( 1193 steps/day ( 95 % CI : 203-2182 ) ) .
RESULTS	A beneficial effect was also found on CRQ dyspnoea score but not on other CRQ domains , CCQ and HADS .
CONCLUSIONS	Our intervention was effective in achieving a behavioural change reflected by a sustained increase in daily physical activity , not accompanied by a sustained increase in maximal exercise capacity after two years of follow-up ( ISRCTN81447311 ) .

###24785463
BACKGROUND	Tension-type headache ( TTH ) is the most common type of primary headache however there is no clear evidence as to which specific treatment is most effective or whether combined treatment is more effective than individual treatments .
OBJECTIVE	To assess the effectiveness of manual therapy techniques , applied to the suboccipital region , on aspects of disability in a sample of patients with tension-type headache .
METHODS	Randomized Controlled Trial .
METHODS	Specialized centre for headache treatment .
METHODS	Seventy-six ( 62 women ) patients ( age : 39.9 10.9 years ) with episodic chronic TTH .
METHODS	Patients were randomly divided into four treatment groups : 1 ) suboccipital soft tissue inhibition ; 2 ) occiput-atlas-axis manipulation ; 3 ) combined treatment of both techniques ; 4 ) control .
METHODS	Four sessions were applied over 4 weeks and disability was assessed before and after treatment using the Headache Disability Inventory ( HDI ) .
METHODS	Headache frequency , severity and the functional and emotional subscales of the questionnaire were assessed .
METHODS	Photophobia , phonophobia and pericranial tenderness were also monitored .
RESULTS	Headache frequency was significantly reduced with the manipulative and combined treatment ( P < 0.05 ) , and the severity and functional subscale of the HDI changed in all three treatment groups ( P < 0.05 ) .
RESULTS	Manipulation treatment also reduced the score on the emotional subscale of the HDI ( P < 0.05 ) .
RESULTS	The combined intervention showed a greater effect at reducing the overall HDI score compared to the group that received suboccipital soft tissue inhibition and to the control group ( both P < 0.05 ) .
RESULTS	In addition , photophobia , phonophobia and pericranial tenderness only improved in the group receiving combined therapy ( P < 0.05 ) .
CONCLUSIONS	When given individually , suboccipital soft tissue inhibition and occiput-atlas-axis manipulation resulted in changes in different parameters related to the disability caused by TTH .
CONCLUSIONS	However , when the two treatments were combined , effectiveness was noted for all aspects of disability and other symptoms including photophobia , phonophobia and pericranial tenderness .
CONCLUSIONS	Although individual manual therapy treatments showed a positive change in headache features , measures of photophobia , photophobia and pericranial tenderness only improved in the group that received the combined treatment suggesting that combined treatment is the most appropriate for symptomatic relief of TTH .

###25435217
OBJECTIVE	The evaluation of the safety and preliminary efficacy of 125 g ocriplasmin intravitreal injection in patients with focal vitreomacular adhesion ( VMA ) and exudative age-related macular degeneration ( AMD ) .
METHODS	Randomized , sham-injection controlled , double-masked , multicenter , phase II trial .
METHODS	A total of 100 patients with VMA and wet AMD were randomized 3:1 to receive 125 g ocriplasmin intravitreal injection or sham injection .
METHODS	Study treatment was administered in the mid-vitreous cavity by injection .
METHODS	Post-treatment safety and efficacy assessments were made at baseline and on days 7 , 14 , and 28 and months 3 , 6 , and 12 after injection .
METHODS	Secondary efficacy end points were exploratory in nature .
METHODS	The safety and tolerability of ocriplasmin were evaluated .
METHODS	The primary efficacy end point was the proportion of patients with VMA release at day 28 after injection .
METHODS	Secondary end points reported included VMA release over time , total posterior vitreous detachment ( PVD ) , change in visual acuity from baseline , and number of anti-vascular endothelial growth factor ( VEGF ) injections .
RESULTS	The safety of ocriplasmin in patients with VMA and wet AMD was shown to be comparable to the known safety profile , with the majority of adverse events in the study eye occurring in the first 7 days after study treatment .
RESULTS	A greater proportion of patients achieved VMA resolution and total PVD at month 12 with ocriplasmin compared with sham treatment .
RESULTS	There was a decrease in the number of anti-VEGF injections with ocriplasmin at month 12 compared with the sham group , although no differences in visual acuity were observed .
CONCLUSIONS	Ocriplasmin treatment in this population seems to be generally safe and well tolerated and resulted in more patients achieving VMA resolution and PVD with less anti-VEGF use compared with sham treatment .

###25258523
BACKGROUND	At present , it is unknown whether the use of nutrient-rich dairy proteins improves the markers of sarcopenia syndrome .
BACKGROUND	Therefore , our proposal was to investigate whether adding 210 g of ricotta cheese daily would improve skeletal muscle mass , handgrip strength , and physical performance in non-sarcopenic older subjects .
METHODS	This was a single-blind randomized clinical trial that included two homogeneous , randomized groups of men and women over 60 years of age .
METHODS	Participants in the intervention group were asked to consume their habitual diet but add 210 g of ricotta cheese ( IG/HD + RCH ) , while the control group was instructed to consume only their habitual diet ( CG/HD ) .
METHODS	Basal and 12-week follow-up measurements included appendicular skeletal muscle mass ( ASMM ) by dual-energy X-ray absorptiometry , handgrip strength by a handheld dynamometer , and physical performance using the short physical performance battery ( SPPB ) and the stair-climb power test ( SCPT ) .
METHODS	The main outcomes were relative changes in ASMM , strength , SPPB , and SCPT .
RESULTS	ASMM increased in the IG/HD + RCH ( 0.63.5 kg ) , but decreased in the CG/HD ( -1.02.6 ) .
RESULTS	The relative change between groups was statistically significant ( P = 0.009 ) .
RESULTS	The relative change in strength in both groups was negative , but the loss of muscle strength was more pronounced in CG/HD , though in this regard statistical analysis found only a tendency ( P = 0.07 ) .
RESULTS	The relative change in the balance-test scores was positive for the IG/HD + RCH , while in the CG/HD it was negative , as those individuals had poorer balance .
RESULTS	In this case , the relative change between groups did reach statistical significance .
CONCLUSIONS	The addition of 210 g of ricotta cheese improves ASMM and balance-test scores , while attenuating the loss of muscle strength .
CONCLUSIONS	These results suggest that adding ricotta cheese to the habitual diet is a promising dietetic strategy that may improve the markers of sarcopenia in subjects without a pronounced loss of ASMM or sarcopenia .

###25577862
BACKGROUND	The heel-lance ( HL ) method for blood collection from the newborn is controversial for the pain it causes .
BACKGROUND	This is the first randomized controlled trial on the management and reduction of pain using the music of Wolfgang Amadeus Mozart ( `` Sonata K. 448 '' ) in premature infants hospitalized in a neonatal intensive care unit ( NICU ) .
BACKGROUND	This study has compared nonpharmacological techniques with standard procedure for reducing pain during HL procedure .
METHODS	Thirty-five premature infants were enrolled , each for 3 HL procedures , of which each was randomized to 1 of the 3 study arms .
METHODS	Arms were then compared in terms of the Premature Infant Pain Profile ( PIPP ) changes by analysis of variance ( ANOVA ) .
RESULTS	One hundred five HL procedures were available for analysis ( 35 standard procedure , 35 music , 35 glucose ) .
RESULTS	Median baseline PIPP was 3 , and median PIPP after the HL procedure was 5 .
RESULTS	PIPP scale change was +3 in the control arm , +1 in the glucose arm , +2 in the music arm ( p = .008 ) .
CONCLUSIONS	Both glucose and music were safe and effective in limiting pain increase when compared to standard procedure in HL procedures in preterm infants .

###25297012
BACKGROUND	Glutamate excitotoxicity might contribute to the pathophysiology of amyotrophic lateral sclerosis .
BACKGROUND	In animal models , decreased excitatory aminoacid transporter 2 ( EAAT2 ) overexpression delays disease onset and prolongs survival , and ceftriaxone increases EAAT2 activity .
BACKGROUND	We aimed to assess the safety and efficacy of ceftriaxone for amyotrophic lateral sclerosis in a combined phase 1 , 2 , and 3 clinical trial .
METHODS	This three-stage randomised , double-blind , placebo-controlled study was done at 59 clinical sites in the USA and Canada between Sept 4 , 2006 , and July 30 , 2012 .
METHODS	Eligible adult patients had amyotrophic lateral sclerosis , a vital capacity of more than 60 % of that predicted for age and height , and symptom duration of less than 3 years .
METHODS	In stages 1 ( pharmacokinetics ) and 2 ( safety ) , participants were randomly allocated ( 2:1 ) to ceftriaxone ( 2 g or 4 g per day ) or placebo .
METHODS	In stage 3 ( efficacy ) , participants assigned to ceftriaxone in stage 2 received 4 g ceftriaxone , participants assigned to placebo in stage 2 received placebo , and new participants were randomly assigned ( 2:1 ) to 4 g ceftriaxone or placebo .
METHODS	Participants , family members , and site staff were masked to treatment assignment .
METHODS	Randomisation was done by a computerised randomisation sequence with permuted blocks of 3 .
METHODS	Participants received 2 g ceftriaxone or placebo twice daily through a central venous catheter administered at home by a trained caregiver .
METHODS	To minimise biliary side-effects , participants assigned to ceftriaxone also received 300 mg ursodeoxycholic acid twice daily and those assigned to placebo received matched placebo capsules .
METHODS	The coprimary efficacy outcomes were survival and functional decline , measured as the slope of Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised ( ALSFRS-R ) scores .
METHODS	Analyses were by intention to treat .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00349622 .
RESULTS	Stage 3 included 66 participants from stages 1 and 2 and 448 new participants .
RESULTS	In total , 340 participants were randomly allocated to ceftriaxone and 173 to placebo .
RESULTS	During stages 1 and 2 , mean ALSFRS-R declined more slowly in participants who received 4 g ceftriaxone than in those on placebo ( difference 051 units per month , 95 % CI 002 to 100 ; p = 00416 ) , but in stage 3 functional decline between the treatment groups did not differ ( 009 , -006 to 024 ; p = 02370 ) .
RESULTS	No significant differences in survival between the groups were recorded in stage 3 ( HR 090 , 95 % CI 071 to 115 ; p = 04146 ) .
RESULTS	Gastrointestinal adverse events and hepatobiliary adverse events were more common in the ceftriaxone group than in the placebo group ( gastrointestinal , 245 of 340 [ 72 % ] ceftriaxone vs 97 of 173 [ 56 % ] placebo , p = 00004 ; hepatobiliary , 211 [ 62 % ] vs 19 [ 11 % ] , p < 00001 ) .
RESULTS	Significantly more participants who received ceftriaxone had serious hepatobiliary serious adverse events ( 41 participants [ 12 % ] ) than did those who received placebo ( 0 participants ) .
CONCLUSIONS	Despite promising stage 2 data , stage 3 of this trial of ceftriaxone in amyotrophic lateral sclerosis did not show clinical efficacy .
CONCLUSIONS	The adaptive design allowed for seamless transition from one phase to another , and central venous catheter use in the home setting was shown to be feasible .
BACKGROUND	National Institute of Neurological Disorders and Stroke .

###25901480
OBJECTIVE	This study describes a single-site investigation on the effects of a randomized double-blind placebo trial targeting duloxetine added to opioid use ( duloxetine + opioid ) against a comparator ( placebo + opioid ) in spine surgery patients , independent of major depression .
METHODS	The double-blind comparator study assessed two groups on opioids : one using duloxetine and the other a placebo .
METHODS	Subjects were administered the respective medication 2 weeks prior to surgery and continued on this for more than 3 months .
METHODS	Subjects were assessed at three times : prior to surgery , 4 weeks postsurgery , and 12 weeks postsurgery .
METHODS	They completed a battery of tests assessing for pain , adjustment , and psychiatric problems .
METHODS	Neurosurgical outpatient and inpatient setting .
METHODS	Sixty-eight patients completed the study .
METHODS	They received one of three types of elective spine surgery .
METHODS	Subjects were given duloxetine or placebo 2 weeks prior to surgery and continued with the regimen for more than 3 months .
RESULTS	The primary focus was pain and second on adjustment factors and psychiatric symptoms : depression and anxiety .
RESULTS	The amount of opioid use presurgery and postsurgery was also evaluated .
RESULTS	There were differences among the groups on Brief Pain Inventory ( BPI ) - Average , the core pain marker , and BPI-Sleep .
RESULTS	Within-subject analyses showed that duloxetine subjects improved significantly from baseline .
RESULTS	For function , post-CIBIC and post-Functional Adjustment Questionnaire were significant , favoring duloxetine .
RESULTS	Reduction of opioid use was not a factor ; both groups ' utilization declined .
RESULTS	For affect , both groups were significantly improved over time .
CONCLUSIONS	Duloxetine seems to improve pain , assist with maintaining function , and reduce intensity of affect .

###24267238
OBJECTIVE	Examine the effect of ABT-335 ( fenofibric acid ) on postprandial lipemia and susceptibility of plasma lipoproteins to Cu ( + + ) - mediated oxidation in patients with metabolic syndrome .
RESULTS	This is a randomized double-blind , placebo-controlled study with cross-over and includes a 4-week wash-out period between the two treatment periods .
RESULTS	At the end of each 8-week treatment period , subjects were challenged with a standardized mixed meal followed by blood collection over the ensuing 6 h. Plasma lipoproteins were isolated by a combination of ultracentrifugation and FPLC for the continuous monitoring of conjugated dienes formation as an assessment of oxidative susceptibility .
RESULTS	Fasting plasma TG was reduced by 20 % ( p < 0.0002 ) and there was a modest reduction in hsCRP ( 6.1 % , p < 0.06 ) .
RESULTS	There was no change in either HDLc or LDLc in these subjects .
RESULTS	Postprandial lipemia was reduced with ABT-335 as demonstrated by a 28.5 % reduction ( p < 0.0005 ) in incremental area under the curve for TG during the 6-h period after the meal challenge .
RESULTS	Lag times for both fasting LDL ( +16 % ) and postprandial LDL ( +28 % ) were increased with the ABT-335 therapy , suggestive of reduced oxidative susceptibility .
RESULTS	Co-incubation with autologous HDL did not reduced LDL oxidative susceptibility in these patients .
CONCLUSIONS	ABT-335 therapy reduced fasting and postprandial triglycerides in patients with metabolic syndrome .
CONCLUSIONS	Autologous HDL may be dysfunctional in these patients as co-incubation with HDL failed to reduce oxidative susceptibility of LDL .
CONCLUSIONS	During ABT-335 therapy , LDL was less susceptible to Cu ( + + ) - mediated oxidative modification , in spite of the lack of changes in LDLc levels .

###25044079
OBJECTIVE	To determine whether culture at a more physiologically cooler temperature , as suggested by limited human and animal data , would improve blastulation and pregnancy rates in human clinical IVF .
METHODS	Paired randomized controlled trial .
METHODS	Academic .
METHODS	Infertile couples ( n = 52 ) with a female partner less than 42 years old with eight or more mature oocytes retrieved .
METHODS	Mature oocytes obtained from a single cohort of oocytes were randomly divided into two groups ; one was cultured at 37C and the other at 36C from the time of ICSI to the time of embryo transfer or vitrification .
METHODS	Paired embryo transfers were accomplished by transferring one euploid embryo from each group .
METHODS	DNA fingerprinting was used as needed to determine the outcome for each embryo .
METHODS	Rate of development of expanded blastocysts suitable for transfer or vitrification ( primary outcome ) , fertilization , aneuploidy , and sustained implantation .
RESULTS	A total of 805 mature oocytes were cultured ; 399 at 36C and 406 at 37C .
RESULTS	Paired analysis demonstrated a higher rate of usable blastocyst formation per zygote at 37C ( 48.4 % ) vs. at 36C ( 41.2 % ) .
RESULTS	Rates of fertilization , aneuploidy , and sustained implantation were equivalent .
CONCLUSIONS	IVF culture at 36C does not improve clinically relevant parameters of embryo development or sustained implantation rates .
BACKGROUND	NCT01506089 .

###25131479
OBJECTIVE	To explore the protective effect and possible mechanism of intensive lipid modulation on the perioperative period of patients with stable coronary artery disease undergoing noncardiac surgery .
METHODS	In the study , 60 patients with stable coronary artery disease undergoing elective noncardiac surgery were randomly divided into intensive lipid modulation group ( n = 30 ) and conventional group ( n = 30 ) .
METHODS	In intensive lipid modulation group , the patients were given atorvastatin 40 mg every night before surgery , 80 mg 12 h before surgery , and 40 mg 2 h before surgery , and 40 mg every night after noncardiac surgery .
METHODS	In conventional group , the patients were given atorvastatin 20 mg every night before surgery and also after the surgery .
METHODS	The occurrence of perioperative major adverse cardiac events ( including sudden cardiac death , acute myocardial infarction , unplanned revascularization ) were compared in the two groups .
METHODS	Preoperative and 48 h postoperative changes of lipid levels and inflammatory markers were also compared in the two groups .
RESULTS	In conventional group , one patient suffered myocardial infarction with acute anterior ST-segment elevation and was given emergency left anterior descending artery interventional reperfusion therapy , and 7 patients suffered asymptomatic myocardial infarction .
RESULTS	In intensive lipid modulation group , one patient suffered asymptomatic myocardial infarction , and the incidence rate of perioperative acute myocardial infarction reduced significantly compared with conventional group ( P < 0.05 ) .
RESULTS	There was no significant difference in preoperative and postoperative changes of lipid levels in the two groups ( P > 0.05 ) , and compared with conventional group , there was significantly lower levels of inflammatory markers in intensive lipid modulation group ( P < 0.05 ) .
CONCLUSIONS	The intensive lipid modulation group significantly reduced the incidence of perioperative major adverse cardiac events especially asymptomatic myocardial infarction , and the inhibition of the inflammatory response may be one of the protective mechanisms , which still needs to be further confirmed by large multicenter randomized controlled clinical trials .

###25332469
BACKGROUND	Calcium inhibits and ascorbic acid ( AA ) enhances iron absorption from iron-fortified foods .
BACKGROUND	Absorption efficiency depends on iron status , although the interaction is unclear .
OBJECTIVE	We investigated the ability of AA to overcome calcium-induced inhibition of iron absorption in children differing in iron status .
METHODS	The effect of calcium ( 0 , 100 , and 200 mg/test meal ) on iron absorption in the absence and presence of AA ( 0 , 42.5 , and 85 mg/test meal ) from a casein/whey-based drink fortified with ferrous sulfate was assessed in a series of randomized crossover studies both in iron-replete ( IR ) Indian schoolchildren and in children with iron deficiency anemia ( IDA ) ( 6-11 y ; n = 14-16 / group ) by using stable isotopes .
RESULTS	In the absence of calcium and AA , iron absorption from the casein/whey-based drink was 20 % lower in IR children than in children with IDA .
RESULTS	The addition of calcium reduced mean iron absorption by 18-27 % , with the effect being stronger for high added calcium ( P < 0.01 ) .
RESULTS	AA at a 2:1 or 4:1 molar ratio enhanced iron absorption by a factor of 2-4 and greatly overcompensated for the inhibitory effect of calcium on iron absorption in a dose-dependent manner ( P < 0.001 ) .
RESULTS	The dose-response effect tended to be stronger ( P < 0.1 ) in the IDA group , and iron status was of far less influence on iron absorption than the enhancing effect of AA .
CONCLUSIONS	When adding AA to iron-fortified milk products , care should be taken not to provide absorbable iron in excess of needs .

###25127173
BACKGROUND	Migraine remains poorly treated , with few effective preventive drugs available .
BACKGROUND	We assessed the safety and efficacy of LY2951742 , a fully humanised monoclonal antibody to calcitonin gene-related peptide , for migraine prevention .
METHODS	We did a randomised , double-blind , placebo-controlled , phase 2 proof-of-concept study at 35 centres in the USA .
METHODS	Patients aged 18-65 years with four to 14 migraine headache days per month were randomly assigned ( 1:1 ) to LY2951742 or placebo by a computerised randomisation scheme .
METHODS	LY2951742 ( 150 mg ) or placebo were given as a subcutaneous injection once every 2 weeks for 12 weeks .
METHODS	The primary endpoint was the mean change in number of migraine headache days per 28-day period assessed at 9-12 weeks .
METHODS	Safety was assessed over 24 weeks , including the 12-week treatment period and the subsequent 12 weeks after study drug administration .
METHODS	Patients and treating investigators were masked to treatment allocation .
METHODS	Analyses were by intention to treat .
METHODS	A mixed-effects model of repeated measures was used , including patient baseline value , treatment , visit , and treatment-by-visit interaction as fixed effects , and patients as random effects .
METHODS	Safety measures were analysed according to the treatment received .
METHODS	This study has been completed and is registered with ClinicalTrials.gov , NCT01625988 .
RESULTS	Between July 31 , 2012 , and Sept 18 , 2013 , 218 patients were randomly assigned to LY2951742 ( n = 108 , but one patient withdrew before treatment ) or placebo ( n = 110 ) .
RESULTS	The mean change from baseline to week 12 in the number of migraine headache days was -42 ( SD 31 ; 625 % decrease ) in the LY2951742 group compared with -30 ( SD 30 ; 423 % decrease ) in the placebo group ( least-squares mean difference -12 , 90 % CI -19 to -06 ; p = 00030 ) .
RESULTS	Adverse events that occurred more frequently with LY2951742 than with placebo included injection site pain , erythema , or both ( 21 [ 20 % ] of 107 vs seven [ 6 % ] of 110 ) , upper respiratory tract infections ( 18 [ 17 % ] vs ten [ 9 % ] ) , and abdominal pain ( six [ 6 % ] vs three [ 3 % ] ) .
RESULTS	There were two serious adverse events reported in the treatment arm and four in the placebo arm , none of which were deemed to be related to the study drug .
CONCLUSIONS	These results provide preliminary evidence that LY2951742 might be beneficial in migraine prevention and provide support for the role of calcitonin gene-related peptide in the pathogenesis of migraine .
CONCLUSIONS	Further controlled studies are needed to assess the safety and efficacy of monoclonal calcitonin gene-related peptide antibodies for the preventive treatment of migraine .
BACKGROUND	Arteaus Therapeutics .

###25995280
BACKGROUND	Although the WHO recommends that complementary feeding in infants should begin at 6 mo of age , it often begins before this in developed countries .
OBJECTIVE	Our objective was to determine whether lactation consultant ( LC ) support , with educational resources given at 4-mo postpartum , can delay the introduction of complementary foods until around 6 mo of age .
METHODS	A total of 802 mother-infant pairs were recruited from the single maternity hospital serving Dunedin , New Zealand ( 59 % response rate ) and randomly assigned to the following : 1 ) usual care ( control group ) ; 2 ) infant sleep education intervention ( Sleep ) ; 3 ) food , activity , and breastfeeding intervention ( FAB ) ; or 4 ) combination ( both ) intervention ( Combo ) .
METHODS	Certified LCs delivered 3 intervention sessions ( late pregnancy and 1-wk and 4-mo postpartum ) .
METHODS	The 4-mo contact used educational resources focused on developmental readiness for complementary foods .
METHODS	Age when complementary foods were introduced was obtained from repeated interviews ( monthly from 3 - to 27-wk postpartum ) .
RESULTS	A total of 49.5 % and 87.2 % of infants received complementary foods before 5 and 6 mo of age , respectively .
RESULTS	There was evidence of group differences in the number of infants introduced to complementary foods before 5 mo ( P = 0.006 ) , with those receiving support and resources ( FAB and Combo groups combined ; 55.6 % ) more likely to wait until at least 5 mo compared with controls ( control and Sleep groups combined ; 43.3 % ) ( OR : 1.52 ; 95 % CI : 1.08 , 2.16 ) .
RESULTS	However , there was no evidence they were more likely to wait until 6 mo of age ( P = 0.52 ) .
RESULTS	Higher maternal age , higher parity , and a less positive attitude toward breastfeeding were positively associated , and drinking alcohol during pregnancy was negatively associated , with later age of introduction of complementary foods .
CONCLUSIONS	Providing an LC and educational resources at 4-mo postpartum to predominantly well-educated , mainly European , women can delay the introduction of complementary foods until 5 mo of age , but not until the WHO recommendation of 6 mo. .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT00892983 .

###25530107
BACKGROUND	Intradialytic hypertension affects 15 % of hemodialysis patients and is associated with increased morbidity and mortality .
BACKGROUND	While intradialytic hypertension is associated with increases in endothelin 1 relative to nitric oxide ( NO ) , the cause of these imbalances is unknown .
BACKGROUND	Invitro evidence suggests that altering plasma sodium levels could affect endothelial-derived vasoregulators and blood pressure ( BP ) .
BACKGROUND	Thus , we hypothesized that compared to high dialysate sodium , low dialysate sodium concentration would lower endothelin 1 levels , increase NO release , and reduce BP .
METHODS	3-week , 2-arm , randomized , crossover study .
METHODS	16 patients with intradialytic hypertension .
METHODS	Low ( 5 mEq/L below serum sodium ) versus high ( 5 mEq/L above serum sodium ) dialysate sodium concentration .
RESULTS	Endothelin 1 , nitrite ( NO2 ( - ) ) , and BP .
METHODS	Mixed linear regression was used to compare the effect of dialysate sodium ( low vs high ) and randomization arm ( low-then-high vs high-then-low ) on intradialytic changes in endothelin 1 , NO2 ( - ) , and BP values .
RESULTS	The average systolic BP throughout all hemodialysis treatments in a given week was lower with low dialysate sodium concentrations compared with treatments with high dialysate sodium concentrations ( parameter estimate,-9 .9 [ 95 % CI,-13 .3 to-6 .4 ] mm Hg ; P < 0.001 ) .
RESULTS	The average change in systolic BP during hemodialysis also was significantly lower with low vs high dialysate sodium concentrations ( parameter estimate,-6 .1 [ 95 % CI,-9 .0 to-3 .2 ] mm Hg ; P < 0.001 ) .
RESULTS	There were no significant differences in intradialytic levels of endothelin 1 or NO2 ( - ) with low vs high dialysate sodium concentrations .
CONCLUSIONS	Carryover effects limited the power to detect significant changes in endothelial-derived vasoregulators , and future studies will require parallel trial designs .
CONCLUSIONS	Low dialysate sodium concentrations significantly decreased systolic BP and ameliorated intradialytic hypertension .
CONCLUSIONS	Longer studies are needed to determine the long-term effects of low dialysate sodium concentrations on BP and clinical outcomes .

###26193719
OBJECTIVE	To observe the efficacy of He-wei Jie-gu ( Chinese characters ) decoction on femoral intertrochanteric fractures after internal fixation in elderly .
METHODS	From January 2010 to January 2012 , 90 elderly patients with osteoporotic intertrochanteric fracture were randomly divided into two groups .
METHODS	The patients in experimental group were treated with open reduction and internal fixation , He-wei Jie-gu decoction and Caltrate D in oral , including 18 males and 27 females with an average age of ( 77.811.3 ) years old ranging from 65 to 89 years old ; the time from injured to operation was 2 to 9 days with an average of ( 6.62.1 ) days ; according to Evans-Jensen classification , 17 cases were in type I , 8 in type II , 15 in type III , 3 in type IV , 2 in type V. Meanwhile , the patients in control group were treated with open reduction and internal fixation , Caltrate D in oral , including 16 males and 29 females with an average age of ( 81.29.6 ) years old ranging from 67 to 91 years old ; the time from injury to operation was 2 to 10 days with an average of ( 6.82.6 ) days ; according to Evans-Jensen classification , 15 cases were in type I , 10 in type II , 14 in type III , 4 in type W , 2 in type V.
METHODS	The VAS score , hip BMD value before and after treatment , fracture healing and the Harris function score after operation were recorded and compared .
RESULTS	All patients were followed up from 3 to 9 months with an average of ( 5.62.8 ) months .
RESULTS	Compared with the control group , the VAS score of the experimental group had an obviously reduction ( F = 98.138 , P < 0.01 ) after treatment ; the hip BMD value at 3 months after treatment in the experimental group was higher than that of the control group ( P < 0.05 ) ; the fracture healing rate of the experimental group was higher than that of the control group ( P < 0.05 ) ; Harris score in 3 months of follow-up in the experimental group was higher than that of the control group ( t = 2.542 , P < 0.05 ) ; all the differences between two groups were statistically significant ( P < 0.05 ) .
CONCLUSIONS	He-wei Jie-gu decoction can reduce postoperative pain and increase bone mineral density after internal fixation of femoral intertrochanteric fracture in elderly , promote the fracture healing and functional recovery in the hip joint .

###25282123
BACKGROUND	A novel musical memory aid has been proposed for aiding laypersons in complying with the American Heart Association ( AHA ) cardiopulmonary resuscitation ( CPR ) guidelines of 100 compressions per minute ( cpm ) .
OBJECTIVE	This study tested usefulness of such a memory aid to improve layperson long-term compliance with CPR compression rate guidelines .
METHODS	A prospective randomized controlled trial was conducted using CPR-untrained laypersons .
METHODS	Subjects received either a standard CPR educational experience ( AHA Heartsaver CPR class ) or an experimental CPR educational experience ( AHA Heartsaver CPR class augmented with a musical metronome ) .
METHODS	Experimental group subjects were taught to perform compressions to the cadence of a pop music song ( The Bee Gees `` Stayin ' Alive '' ; Saturday Night Fever , The Original Movie Soundtrack ; Polygram International Music , 1977 ) with a tempo of 100 beats/min .
METHODS	Compression rates , depth of compressions , and correct compressions were measured initially and upon retesting 6 weeks post-training .
RESULTS	Control subjects had a higher mean compression rate both immediately ( 121 [ standard deviation { SD } = 21 ] vs. 109 [ SD = 15 ] cpm ; 95 % confidence interval [ CI ] of mean difference 4-19 ; p = 0.002 ) and at follow-up ( 120 [ SD = 20 ] vs. 111 [ SD = 13 ] cpm ; 95 % CI of mean difference 2-16 ; p = 0.014 ) .
RESULTS	Compression rates stratified to 100-120 cpm demonstrated no difference between groups initially ( 39 % vs. 48 % ; p = 0.382 ) , but more experimental subjects maintained these rates at follow-up ( 43 % vs. 74 % ; p = 0.003 ) .
CONCLUSIONS	Subjects trained to use a musical metronome more often maintained a compression rate of 100-120 cpm at 6-week follow-up , suggesting the memory aid may improve long-term guideline adherence .

###24819710
BACKGROUND	Pain is frequent and distressing in people with dementia , but no randomized controlled trials have evaluated the effect of analgesic treatment on pain intensity as a key outcome .
METHODS	Three hundred fifty-two people with dementia and significant agitation from 60 nursing home units were included in this study .
METHODS	These units , representing 18 nursing homes in western Norway , were randomized to a stepwise protocol of treating pain ( SPTP ) or usual care .
METHODS	The SPTP group received acetaminophen , morphine , buprenorphine transdermal patch and pregabalin for 8 weeks , with a 4-week washout period .
METHODS	Medications were governed by the SPTP and each participant 's existing prescriptions .
METHODS	We obtained pain intensity scores from 327 patients ( intervention n = 164 , control n = 163 ) at five time points assessed by the primary outcome measure , Mobilization-Observation-Behaviour-Intensity-Dementia-2 ( MOBID-2 ) Pain Scale .
METHODS	The secondary outcome was activities of daily living ( ADL ) .
METHODS	We used a linear intercept mixed model in a two-way repeated measures configuration to assess change over time and between groups .
RESULTS	The SPTP conferred significant benefit in MOBID-2 scores compared with the control group [ average treatment effect ( ATE ) -1.388 ; p < 0.001 ] at week 8 , and MOBID-2 scores worsened during the washout period ( ATE = -0.701 ; p = 0.022 ) .
RESULTS	Examining different analgesic treatments , benefit was conferred to patients receiving acetaminophen compared with the controls at week 2 ( ATE = -0.663 ; p = 0.010 ) , continuing to increase until week 8 ( ATE = -1.297 ; p < 0.001 ) .
RESULTS	Although there were no overall improvements in ADL , an increase was seen in the group receiving acetaminophen ( ATE = +1.0 ; p = 0.022 ) .
CONCLUSIONS	Pain medication significantly improved pain in the intervention group , with indications that acetaminophen also improved ADL function .

###25622633
OBJECTIVE	To explore the clinical efficacy and safety of compound digestive enzyme tablet in the treatment of dyspepsia .
METHODS	A randomized , double-blind , double-dummy , positive drug parallel controlled , multicenter clinical trial was conducted for 203 dyspeptic patients from October 2011 to August 2012 .
METHODS	And they were randomized into group A ( experimental , n = 106 ) and group B ( control , n = 97 ) .
METHODS	Group A received 1 tablet of compound digestive enzyme tablet ( Bearse ) plus 2 analog capsules of compound digestive enzyme thrice daily .
METHODS	And group B had 2 capsules of compound digestive enzyme capsule ( Dages ) plus 1 analog tablet of compound digestive enzyme thrice daily .
METHODS	The total duration of drug treatment was 2 weeks .
METHODS	There were 3 follow-up visits ( W0 , W1 , W2 ) .
METHODS	The primary endpoint was the total effective rate of all dyspeptic symptoms .
RESULTS	The total efficacy rate of groups A and B were 80.2 % ( 85/106 ) and 79.4 % ( 77/97 ) ( P > 0.05 ) .
RESULTS	The adverse effects were 1.9 % ( 2/106 ) and 4.1 % ( 4/97 ) in groups A and B ( P > 0.05 ) .
RESULTS	The adverse effects were mild in both groups .
CONCLUSIONS	Compound digestive enzyme tablet and capsule are effective and safe for patients with dyspepsia .
CONCLUSIONS	And compound digestive enzymes tablet is comparable to compound digestive enzyme capsule .

###25322165
BACKGROUND	Onychomycosis is difficult to cure .
BACKGROUND	Systemic and topical treatments , including the 1,064-nm Nd : YAG laser , are not very effective when used individually .
OBJECTIVE	To compare the efficacy and safety of combined treatment with a long-pulsed 1,064-nm Nd : YAG laser and oral terbinafine with those of either treatment alone .
METHODS	We randomly divided 53 patients with a total of 90 infected nails into 3 treatment groups : the T group received oral terbinafine , the L group received long-pulsed Nd : YAG laser treatment , and the T + L group received both treatments .
METHODS	We evaluated the mycological clearance rate ( MCR ) and the clinical clearance rate ( CCR ) of the 3 groups at Weeks 4 , 8 , 12 , 16 , and 24 .
RESULTS	The MCR and CCR increased in all 3 groups in a time-dependent manner .
RESULTS	The MCR and CCR of the T + L group were significantly higher than those of the T group and the L group at Weeks 8 , 12 , 16 , and 24 ( p < .05 ) .
CONCLUSIONS	These data indicate that 12 weeks of combined treatment with a long-pulsed Nd : YAG laser and oral terbinafine produce more rapid and effective mycological and clinical clearance in patients with onychomycosis than either treatment alone , without any obvious side effects .

###24658221
OBJECTIVE	This study investigated the effects of ethanol consumption on recovery from traditional resistance exercise in recreationally trained individuals .
METHODS	Nine recreationally trained volunteers ( eight males and one female , 26 4 yr , 81 4 kg ) conducted four resistance exercise sessions and consumed a low ( 0.6 ( females ) and 0.7 ( males ) g kg ( -1 ) body mass ) or a high dose ( 1.2 or 1.4 g kg ( -1 ) body mass ) of ethanol 1-2 .5 h after exercise on two occasions .
METHODS	The first session was for familiarization with the tests and exercises and was performed without ethanol consumption .
METHODS	As a control trial , alcohol-free drinks were consumed after the exercise session .
METHODS	The sequence of trials , with low and high ethanol doses and alcohol-free drinks ( control ) , was randomized .
METHODS	Maximal voluntary contractions ( MVC ) ( knee extension ) , electrically stimulated contractions ( knee extension ) , squat jumps , and hand grip strength were assessed 10-15 min and 12 and 24 h after the ethanol/placebo drinks .
METHODS	In addition to a baseline sample , blood was collected 1 , 12 , and 24 h after the ethanol/placebo drinks .
METHODS	The exercise session comprised 4 8 repetition maximum of squats , leg presses , and knee extensions .
RESULTS	MVC were reduced by 13 % -15 % immediately after the exercise sessions ( P < 0.01 ) .
RESULTS	MVC , electrically stimulated force , and squat jump performance were recovered 24 h after ethanol drinks .
RESULTS	MVC was not fully recovered at 24 h in the control trial .
RESULTS	Compared with those in the control , cortisol increased and the free testosterone/cortisol ratio were reduced after the high ethanol dose ( P < 0.01 ) .
CONCLUSIONS	Neither a low nor a high dose of ethanol adversely affected recovery of muscle function after resistance exercise in recreationally strength-trained individuals .
CONCLUSIONS	However , the increased cortisol levels and reduced testosterone/cortisol ratio after the high ethanol dose could translate into long-term negative effects .

###24418949
BACKGROUND	Early detection of melanoma improves survival .
BACKGROUND	Since many melanoma patients and their spouses seek the care of a physician after discovering their melanoma , an ongoing study will determine the efficacy of teaching at-risk melanoma patients and their skin check partner how to conduct skin self-examinations ( SSEs ) .
BACKGROUND	Internet-based health behavior interventions have proven efficacious in creating behavior change in patients to better prevent , detect , or cope with their health issues .
BACKGROUND	The efficacy of electronic interactive SSE educational intervention provided on a tablet device has not previously been determined .
OBJECTIVE	The electronic interactive educational intervention was created to develop a scalable , effective intervention to enhance performance and accuracy of SSE among those at-risk to develop melanoma .
OBJECTIVE	The intervention in the office was conducted using one of the following three methods : ( 1 ) in-person through a facilitator , ( 2 ) with a paper workbook , or ( 3 ) with a tablet device used in the clinical office .
OBJECTIVE	Differences related to method of delivery were elucidated by having the melanoma patient and their skin check partner provide a self-report of their confidence in performing SSE and take a knowledge-based test immediately after receiving the intervention .
METHODS	The three interventions used 9 of the 26 behavioral change techniques defined by Abraham and Michie to promote planning of monthly SSE , encourage performing SSE , and reinforce self-efficacy by praising correct responses to knowledge-based decision making and offering helpful suggestions to improve performance .
METHODS	In creating the electronic interactive SSE educational intervention , the educational content was taken directly from both the scripted in-person presentation delivered with Microsoft PowerPoint by a trained facilitator and the paper workbook training arms of the study .
METHODS	Enrollment totaled 500 pairs ( melanoma patient and their SSE partner ) with randomization of 165 pairs to the in-person , 165 pairs to the workbook , and 70 pairs to electronic interactive SSE educational intervention .
RESULTS	The demographic survey data showed no significant mean differences between groups in age , education , or income .
RESULTS	The tablet usability survey given to the first 30 tablet pairs found that , overall , participants found the electronic interactive intervention easy to use and that the video of the doctor-patient-partner dialogue accompanying the dermatologist 's examination was particularly helpful in understanding what they were asked to do for the study .
RESULTS	The interactive group proved to be just as good as the workbook group in self-confidence of scoring moles , and just as good as both the workbook and the in-person intervention groups in self-confidence of monitoring their moles .
RESULTS	While the in-person intervention performed significantly better on a skill-based quiz , the electronic interactive group performed significantly better than the workbook group .
RESULTS	The electronic interactive and in-person interventions were more efficient ( 30 minutes ) , while the workbook took longer ( 45 minutes ) .
CONCLUSIONS	This study suggests that an electronic interactive intervention can deliver skills training comparable to other training methods , and the experience can be accommodated during the customary outpatient office visit with the physician .
CONCLUSIONS	Further testing of the electronic interactive intervention 's role in the anxiety of the pair and pair-discovered melanomas upon self-screening will elucidate the impact of these tools on outcomes in at-risk patient populations .
BACKGROUND	ClinicalTrials.gov NCT01013844 ; http://clinicaltrials.gov/show/NCT01013844 ( Archived by WebCite at http://www.webcitation.org/6LvGGSTKK ) .

###24984081
BACKGROUND	Experts advise against parenteral nutrition ( PN ) for patients with advanced cancer at the end of life .
BACKGROUND	But because many patients and families fear starvation , many physicians administer PN to patients with terminal cancer in Korea .
OBJECTIVE	We designed this study to investigate the effect of PN on survival in patients with terminal cancer at the end of life .
METHODS	We planned a randomized phase II study enrolling 116 patients randomized to receive either fluid or PN .
METHODS	Eligible patients are who could not tolerate enteral feeding and had short life expectancies ( < 3 months ) due to progressive cancer .
METHODS	Patients with functioning bowels were excluded .
METHODS	The primary end point was overall survival and the secondary end point was total administered calories .
RESULTS	We prospectively enrolled 31 consecutive patients and 16 patients were assigned to the PN group .
RESULTS	The study ended early because many patients and families were extremely concerned about starvation .
RESULTS	The baseline characteristics , including nutritional parameters , were not significantly different between the two groups .
RESULTS	The mean administered calories was 374.7 ( 71.7 ) kcal/d for the fluid group and 1286.8 ( 108.3 ) kcal/d for the PN group ( p < 0.001 ) .
RESULTS	Median survival was 8 days ( 95 % confidence interval [ CI ] , 5.7-10 .3 days ) in the fluid group and 13 days ( 95 % CI : 3.1-22 .9 days ) in the PN group , and this difference was not statistically significant ( p = 0.982 by Log-rank test ) .
CONCLUSIONS	This study did not conclusively determine the role of PN for patients with advanced cancer , however , PN support failed to significantly prolong survival in these patients compared to similar patients receiving only fluid .

###25720702
OBJECTIVE	Breast ptosis may be caused by several factors , including significant weight loss , pregnancy , long breastfeeding periods , and involution of the postmenopausal breast tissue .
OBJECTIVE	The authors performed a prospective study to evaluate patient satisfaction and the rate of complications after modified round block mastopexy versus traditional round block mastopexy .
METHODS	Forty-four patients fulfilled the inclusion criteria for undergoing round block mastopexy in a prospective randomized controlled study performed from 2007 to 2008 .
METHODS	All the patients received polyurethane silicone implants .
METHODS	Group A included patients who underwent the traditional round block technique described by Benelli .
METHODS	Group B included patients who underwent the traditional round block and 4 cardinal glando-glandular permanent sutures .
METHODS	The overall satisfaction with body appearance after breast mastopexy was rated on a scale of 1 ( poor ) , 2 ( fair ) , 3 ( good ) , 4 ( very good ) , and 5 ( excellent ) .
RESULTS	Group A patient ages ranged from 28 to 52 years and in Group B ranged from 29 to 49 years .
RESULTS	The mean implant volume was 215 cc in both Groups .
RESULTS	The complication and satisfaction rates for both Groups are reported .
CONCLUSIONS	The combination of the cardinal glandulo-glandular sutures along with the traditional round block appears to be key to preventing the areolar enlargement and persistent breast ptosis .
CONCLUSIONS	The satisfaction rates in patients who underwent the modified round mastopexy appear superior when compared to the traditional round block mastopexy .
CONCLUSIONS	Furhter long-term follow-up need to be performed in order to confirm the favorable results seen in this series of cases .

###25425162
BACKGROUND	Urinary tract infections ( UTI ) are the most frequent bacterial infection affecting women and account for about 15 % of antibiotics prescribed in primary care .
BACKGROUND	However , some women with a UTI are not prescribed antibiotics or are prescribed the wrong antibiotics , while many women who do not have a microbiologically confirmed UTI are prescribed antibiotics .
BACKGROUND	Inappropriate antibiotic prescribing unnecessarily increases the risk of side effects and the development of antibiotic resistance , and wastes resources .
METHODS	614 adult female patients will be recruited from four primary care research networks ( Wales , England , Spain , the Netherlands ) and individually randomised to either POCT guided care or the guideline-informed ` standard care ' arm .
METHODS	Urine and stool samples ( where possible ) will be obtained at presentation ( day 1 ) and two weeks later for microbiological analysis .
METHODS	All participants will be followed up on the course of their illness and their quality of life , using a 2 week self-completed symptom diary .
METHODS	At 3 months , a primary care notes review will be conducted for evidence of further evidence of treatment failures , recurrence , complications , hospitalisations and health service costs .
CONCLUSIONS	Although the Flexicult POCT is used in some countries in routine primary care , it 's clinical and cost effectiveness has never been evaluated in a randomised clinical trial .
CONCLUSIONS	If shown to be effective , the use of this POCT could benefit individual sufferers and provide evidence for health care authorities to develop evidence based policies to combat the spread and impact of the unprecedented rise of infections caused by antibiotic resistant bacteria in Europe .
BACKGROUND	ISRCTN65200697 ( Registered 10 September 2013 ) .

###24656175
BACKGROUND	During clinical development of the licensed Japanese encephalitis chimeric virus vaccine ( JE-CV ) , the neutralization capacity of vaccine-induced antibodies was assessed against the vaccine virus and against well characterized wild-type ( wt ) viruses isolated between 1949-1991 .
BACKGROUND	We assessed whether JE-CV-induced antibodies can also neutralize more recent wt Japanese encephalitis virus ( JEV ) isolates including a genotype 1 isolate .
METHODS	Sera from 12-18month-old children who received a single dose of JE-CV in a phase III study in Thailand and the Philippines ( ClinicalTrials.gov NCT00735644 ) were randomly selected and pooled according to neutralization titer against JE-CV into eight samples .
METHODS	Neutralization was assessed by plaque reduction neutralization tests ( PRNT50 ) against three recent isolates from JEV genotypes 1 and 3 in addition to four JEV previously tested .
RESULTS	Neutralization titers against the three recent JEV strains were comparable to those observed previously against other strains and the vaccine virus .
RESULTS	The observed differences between responses to genotype 1 and 3 viruses were within assay variability for the PRNT50 .
CONCLUSIONS	The results were consistent with previously generated data on the neutralization of wt JEV isolates , immune responses induced by JE-CV neutralize recently isolated virus from southeast ( SE ) Asia and India .

###25502610
BACKGROUND	Evidence regarding what comprises effective education for acne vulgaris patients is lacking .
BACKGROUND	Internet-based education may improve patient knowledge of this condition .
OBJECTIVE	Our objective was to compare the effectiveness of standard web-based education and an automated counseling website in improving acne knowledge .
METHODS	In a randomized trial , participants visited either a standard website or an automated counseling website to learn about acne .
METHODS	Multiple-choice questions were administered at baseline and after 12weeks to assess change in acne knowledge .
RESULTS	A total of 97 high school students were enrolled , and 95 completed the study .
RESULTS	The standard website group had a significant increase in knowledge from baseline ( 3.611.22 ) to 12-week follow-up ( 5.461.31 , p < 0.001 ) .
RESULTS	Similarly , the automated counseling website group had a significant increase in knowledge between both time points ( 3.531.50 vs. 6.491.06 , p < 0.001 ) .
RESULTS	After 12 weeks , mean improvement in knowledge was higher in the automated counseling group ( 2.961.85 ) than in the standard website group ( 1.851.46 , d = 0.67 , p = 0.002 ) .
RESULTS	The number of website visits was positively correlated with improvement in knowledge in both groups .
RESULTS	Finally , the automated counseling website group rated their educational material more useful ( p = 0.004 ) and more enjoyable to view ( p = 0.003 ) than did the standard website group .
CONCLUSIONS	This study is limited to adolescents with mild-to-moderate acne vulgaris .
CONCLUSIONS	Internet-based patient education appears to be an effective method of improving acne knowledge among adolescents .

###26156739
BACKGROUND	Neuropeptide Y is a key peptide affecting adiposity and has been related to obesity risk .
BACKGROUND	However , little is known about the role of NPY variations in diet-induced change in adiposity .
OBJECTIVE	The objective was to examine the effects of NPY variant rs16147 on central obesity and abdominal fat distribution in response to dietary interventions .
METHODS	We genotyped a functional NPY variant rs16147 among 723 participants in the Preventing Overweight Using Novel Dietary Strategies trial .
METHODS	Changes in waist circumference ( WC ) , total abdominal adipose tissue , visceral adipose tissue , and subcutaneous adipose tissue ( SAT ) from baseline to 6 and 24 mo were evaluated with respect to the rs16147 genotypes .
METHODS	Genotype-dietary fat interaction was also examined .
RESULTS	The rs16147 C allele was associated with a greater reduction in WC at 6 mo ( P < 0.001 ) .
RESULTS	In addition , the genotypes showed a statistically significant interaction with dietary fat in relation to WC and SAT ( P-interaction = 0.01 and 0.04 ) : the association was stronger in individuals with high-fat intake than in those with low-fat intake .
RESULTS	At 24 mo , the association remained statistically significant for WC in the high-fat diet group ( P = 0.02 ) , although the gene-dietary fat interaction became nonsignificant ( P = 0.30 ) .
RESULTS	In addition , we found statistically significant genotype-dietary fat interaction on the change in total abdominal adipose tissue , visceral adipose tissue , and SAT at 24 mo ( P = 0.01 , 0.05 , and 0.04 ) : the rs16147 T allele appeared to associate with more adverse change in the abdominal fat deposition in the high-fat diet group than in the low-fat diet group .
CONCLUSIONS	Our data indicate that the NPY rs16147 genotypes affect the change in abdominal adiposity in response to dietary interventions , and the effects of the rs16147 single-nucleotide polymorphism on central obesity and abdominal fat distribution were modified by dietary fat .

###25562479
OBJECTIVE	To compare clinical and subjective quality-of-life ( QoL ) data for teenagers wearing daily disposable contact lenses or spectacles .
METHODS	This open-label study randomized subjects ( aged 13 to 19 years ) with no previous contact lens wear experience to nelfilcon A ( DAILIES AquaComfort Plus ) contact lenses or spectacles for 6 months .
METHODS	A full clinical workup , as well as subjective QoL measures using the Pediatric Refractive Error Profile and Quality of Life Impact of Refractive Correction questionnaires , was conducted at baseline and at week 4 and months 3 and 6 , with an additional study visit at week 2 for subjects randomized to wear contact lenses .
RESULTS	A total of 110 teenagers were enrolled in the study ; 13 discontinued before study completion , 10 ( 17.5 % ) from the contact lens group and 3 ( 5.7 % ) from the spectacle group ( p = 0.04 ) .
RESULTS	Visual acuity was good for both groups at all study visits .
RESULTS	Biomicroscopy assessments were similar at baseline for both groups .
RESULTS	Significant differences in Pediatric Refractive Error Profile responses were noted between vision correction groups across visits for appearance ( p < 0.001 ) , satisfaction ( p < 0.001 ) , activities ( p < 0.001 ) , peer perception ( p = 0.003 ) , and overall score ( p < 0.001 ) .
RESULTS	For Quality of Life Impact of Refractive Correction , the contact lens group gave more favorable responses than the spectacle group ( p = 0.02 ) .
RESULTS	After 6 months of wearing contact lenses , teenagers had a more positive attitude toward comfort , vision , and safety with contact lenses .
RESULTS	No serious adverse events were reported during the study .
CONCLUSIONS	The daily disposable lenses used in this study are suitable for vision correction for teenagers , offering improvements in QoL measures during the first month of wear , including appearance , satisfaction , activities , and peer perceptions , without negatively impacting vision or eye health .
CONCLUSIONS	Teenagers were able to handle contact lenses with the same amount of confidence as spectacles .

###24423356
BACKGROUND	Severe deficiencies of testosterone ( T ) and GH are associated with low bone mineral density ( BMD ) and increased fracture risk .
BACKGROUND	Replacement of T in hypogonadal men improves several bone parameters .
BACKGROUND	Replacement of GH in GH-deficient men improves BMD .
OBJECTIVE	Our objective was to determine whether T and GH treatment together improves the structural and mechanical parameters of bone more than T alone in men with hypopituitarism .
METHODS	This randomized , prospective , 2-year study included 32 men with severe deficiencies of T and GH due to panhypopituitarism .
METHODS	Subjects were randomized to receive T alone ( n = 15 ) or T and GH ( n = 17 ) for 2 years .
METHODS	We evaluated magnetic resonance microimaging-derived structural ( bone volume fraction [ BVF ] and trabecular thickness ) and mechanical ( axial stiffness [ AS ] , a measure of bone strength ) properties of the distal tibia at baseline and after 1 and 2 years of treatment .
RESULTS	Treatment with T and GH did not affect BVF , thickness , or AS differently from T alone .
RESULTS	T treatment in all subjects for 2 years increased trabecular BVF by 9.6 % ( P < .0001 ) , trabecular thickness by 2.6 % ( P < .001 ) , and trabecular AS by 9.8 % ( P < .001 ) .
RESULTS	In contrast , testosterone treatment in all subjects significantly increased cortical thickness by 2.4 % ( P < .01 ) but decreased cortical BVF by -4.7 % ( P < .01 ) and cortical AS by -6.9 % ( P < .01 ) .
CONCLUSIONS	Combined T and GH treatment of men with hypopituitarism for 2 years did not improve the measured structural or mechanical parameters of the distal tibia more than T alone .
CONCLUSIONS	However , testosterone significantly increased the structural and mechanical properties of trabecular bone but decreased most of these properties of cortical bone , illustrating the potential importance of assessing trabecular and cortical bone separately in future studies of the effect of testosterone on bone .

###24260334
BACKGROUND	Traumatic brain injury ( TBI ) is the leading cause of death and disability in the US .
BACKGROUND	Approximately 70-90 % of the TBI cases are classified as mild , and up to 25 % of them will not recover and suffer chronic neurocognitive impairments .
BACKGROUND	The main pathology in these cases involves diffuse brain injuries , which are hard to detect by anatomical imaging yet noticeable in metabolic imaging .
BACKGROUND	The current study tested the effectiveness of Hyperbaric Oxygen Therapy ( HBOT ) in improving brain function and quality of life in mTBI patients suffering chronic neurocognitive impairments .
RESULTS	The trial population included 56 mTBI patients 1-5 years after injury with prolonged post-concussion syndrome ( PCS ) .
RESULTS	The HBOT effect was evaluated by means of prospective , randomized , crossover controlled trial : the patients were randomly assigned to treated or crossover groups .
RESULTS	Patients in the treated group were evaluated at baseline and following 40 HBOT sessions ; patients in the crossover group were evaluated three times : at baseline , following a 2-month control period of no treatment , and following subsequent 2-months of 40 HBOT sessions .
RESULTS	The HBOT protocol included 40 treatment sessions ( 5 days/week ) , 60 minutes each , with 100 % oxygen at 1.5 ATA .
RESULTS	`` Mindstreams '' was used for cognitive evaluations , quality of life ( QOL ) was evaluated by the EQ-5D , and changes in brain activity were assessed by SPECT imaging .
RESULTS	Significant improvements were demonstrated in cognitive function and QOL in both groups following HBOT but no significant improvement was observed following the control period .
RESULTS	SPECT imaging revealed elevated brain activity in good agreement with the cognitive improvements .
CONCLUSIONS	HBOT can induce neuroplasticity leading to repair of chronically impaired brain functions and improved quality of life in mTBI patients with prolonged PCS at late chronic stage .
BACKGROUND	ClinicalTrials.gov NCT00715052 .

###24878214
OBJECTIVE	The Grip on Challenging Behavior care program was developed using the current guidelines and models on managing challenging behavior in dementia in nursing homes .
OBJECTIVE	It was hypothesized that the use of the care program would lead to a decrease in challenging behavior and in the prescription of psychoactive drugs without increase in use of restraints .
METHODS	A randomized controlled trial was undertaken using a stepped-wedge design to implement the care program and to evaluate the effects .
METHODS	An assessment of challenging behavior and psychoactive medication was undertaken every 4 months on all participating units followed by the introduction of the care program in a group of 3 to 4 units .
METHODS	A total of 6 time assessments took place over 20 months .
METHODS	Seventeen dementia special care units of different nursing homes .
METHODS	A total of 659 residents of dementia special care units .
METHODS	All residents with dementia on the unit were included .
METHODS	Units were assigned by random allocation software to 1 of 5 groups with different starting points for the implementation of the care program .
METHODS	A care program consisting of various assessment procedures and tools , which ensure a multidisciplinary approach and which structure the process of managing challenging behavior in dementia .
METHODS	Challenging behavior was measured using the Cohen-Mansfield Agitation Inventory ( CMAI ) and the Neuropsychiatric Inventory .
METHODS	Research assistants ( blinded for intervention status of the unit ) interviewed nurses on the units about challenging behavior .
METHODS	Data on psychoactive drugs and restraints were retrieved from resident charts .
RESULTS	A total of 2292 assessments took place involving 659 residents ( 1126 control measurements , 1166 intervention measurements ) .
RESULTS	The group of residents who remained in the intervention condition compared with the group in the control condition differed significantly in the CMAI change scores between successive assessments [ -2.4 CMAI points , 95 % confidence interval ( CI ) -4.3 to -0.6 ] .
RESULTS	No significant effects were found for the control-to-intervention group compared with the group who remained in the control group ( 0.0 CMAI points , 95 % CI -2.3 to 2.4 ) .
RESULTS	Significant effects were found on 5 of the 12 Neuropsychiatric Inventory items and on the use of antipsychotics ( odds ratio 0.54 , 95 % CI 0.37 - 0.80 ) and antidepressants ( odds ratio 0.65 , 95 % CI 0.44-0 .94 ) .
RESULTS	No effect on use of restraints was observed .
CONCLUSIONS	The Grip on Challenging behavior program was able to diminish some forms of challenging behavior and the use of psychoactive drugs .

###24384538
BACKGROUND	HIV-infected prisoners have a high prevalence of alcohol use disorders and commonly relapse to alcohol soon after release to the community which is linked to high morbidity , poor antiretroviral therapy ( ART ) adherence and increased sexual risk-taking behaviors .
BACKGROUND	Extended-release naltrexone ( XR-NTX ) effectively reduces relapse to alcohol in alcohol dependent persons , yet it remains unexamined among criminal justice system ( CJS ) populations transitioning to the community .
METHODS	A randomized double-blind , placebo-controlled trial of XR-NTX to improve HIV treatment outcomes via reducing relapse to alcohol use after prison release for HIV-infected hazardous drinking and alcohol dependent prisoners is discussed .
RESULTS	Acceptability of study participation is high with 86 % of those referred who met eligibility criteria and 85 % of those who were able to receive injections prior to release accepted injections , yet important implementation issues are identified and addressed during the study and are discussed in this paper .
CONCLUSIONS	Medication-assisted therapies for prevention of relapse to alcohol use for CJS populations transitioning to the community , especially for HIV-infected patients , are urgently needed in order to reduce alcohol relapse after release and improve HIV treatment outcomes and contribute to improved individual and public health .

###24753491
METHODS	To examine whether the consumption of a Mediterranean diet ( MedDiet ) , compared with a low-fat diet , interacts with two single nucleotide polymorphisms at the tumor necrosis factor alpha gene ( rs1800629 , rs1799964 ) in order to improve triglycerides ( TG ) , glycemic control , and inflammation markers .
RESULTS	Genotyping , biochemical measurements , dietary intervention , and oral fat load test meal were determined in 507 metabolic syndrome ( MetS ) patients selected from all the subjects included in CORDIOPREV clinical trial ( n = 1002 ) .
RESULTS	At baseline , G/G subjects ( n = 408 ) at the rs1800629 polymorphism , showed higher fasting and postprandial TG ( p = 0.003 and p = 0.025 , respectively ) , and high sensitivity C-reactive protein ( hsCRP ) ( p = 0.003 ) plasma concentrations than carriers of the minor A-allele ( G/A + A/A ) ( n = 99 ) .
RESULTS	After 12 months of MedDiet , baseline differences between genotypes disappeared .
RESULTS	The decrease in TG and hsCRP was statistically significant in G/G subjects ( n = 203 ) compared with carriers of the minor A-allele ( p = 0.005 and p = 0.034 , respectively ) ( n = 48 ) .
RESULTS	No other gene-diet interactions were observed in either diet .
CONCLUSIONS	These results suggest that the rs1800629 at the tumor necrosis factor alpha gene interacts with MedDiet to influence TG metabolism and inflammation status in MetS subjects .
CONCLUSIONS	Understanding the role of gene-diet interactions may be the best strategy for personalized treatment of MetS .

###24336783
OBJECTIVE	We investigated real-life oral anticoagulation ( OAC ) treatment after surgical ablation and examined its adherence to current recommendations .
OBJECTIVE	We also explored factors related to OAC use preoperatively and at follow-up .
METHODS	One hundred and fifteen patients with atrial fibrillation ( AF ) were evaluated during 12-month follow-up after surgery .
METHODS	Patients were divided into two categories according to the congestive heart failure , hypertension , age 75 years , diabetes and prior stroke [ or transient ischaemic attack or thromboembolism ] ( CHADS2 ) score : 60 patients were assigned to the high-risk group ( CHADS2 score 2 ) and 55 to the low-risk group ( CHADS2 score 1 ) .
METHODS	OAC use was defined as guideline adherent , undertreatment or overtreatment .
RESULTS	Baseline overall guideline adherence was 62 % .
RESULTS	OAC was underprescribed in high-risk patients and overprescribed in low-risk patients ( both , P < 0.001 ) .
RESULTS	The only factor associated with OAC use after logistic regression analysis were age > 75 years ( P = 0.01 ) and preoperative AF > paroxysmal ( P = 0.013 ) .
RESULTS	Overall guideline adherence at 12-month follow-up showed a trend towards a better adherence in the sinus rhythm ( SR ) subgroup ( 74 % vs 55 % , P = 0.02 ) .
RESULTS	OAC was underprescribed in high-risk patients and overprescribed in low-risk patients ( both P < 0.001 ) .
RESULTS	After logistic regression analysis , preoperative OAC use ( P = 0.007 ) and other indications for OAC ( P = 0.01 ) were predictors of anticoagulation treatment .
CONCLUSIONS	Real-life OAC prescription in AF patients showed a moderate guideline adherence , with high-risk patients being undertreated and low-risk patients being overtreated .
CONCLUSIONS	These findings stress the importance that antithrombotic treatment in patients undergoing AF surgery needs to be critically re-evaluated .

###25296334
BACKGROUND	Memory T-cells are mediators of transplant injury , and no therapy is known to prevent the development of cross-reactive memory alloimmunity .
BACKGROUND	Activated vitamin D is immunomodulatory , and vitamin D deficiency , common in hemodialysis patients awaiting transplantation , is associated with a heightened alloimmune response .
BACKGROUND	Thus , we tested the hypothesis that vitamin D3 supplementation would prevent alloreactive T-cell memory formation in vitamin D-deficient hemodialysis patients .
RESULTS	We performed a 12-month single-center pilot randomized , controlled trial of 50,000 IU/week of cholecalciferol ( D3 ) versus no supplementation in 96 hemodialysis patients with serum 25 ( OH ) D < 25 ng/mL , measuring effects on serum 25 ( OH ) D and phenotypic and functional properties of T-cells .
RESULTS	Participants were randomized 2:1 to active treatment versus control .
RESULTS	D3 supplementation increased serum 25 ( OH ) D at 6 weeks ( 13.5 [ 11.2 ] ng/mL to 42.5 [ 18.5 ] ng/mL , p < 0.001 ) and for the duration of the study .
RESULTS	No episodes of sustained hypercalcemia occurred in either group .
RESULTS	Results of IFN ELISPOT-based panel of reactive T-cell assays ( PRT ) , quantifying alloreactive memory , demonstrated greater increases in the controls over 1 year compared to the treatment group ( delta PRT in treatment 104.8 + / -330.8 vs 252.9 + / -431.3 in control ) , but these changes in PRT between groups did not reach statistical significance ( p = 0.25 ) .
CONCLUSIONS	D3 supplements are safe , effective at treating vitamin D deficiency , and may prevent time-dependent increases in T-cell alloimmunity in hemodialysis patients , but their effects on alloimmunity need to be confirmed in larger studies .
CONCLUSIONS	These findings support the routine supplementation of vitamin D-deficient transplant candidates on hemodialysis and highlight the need for large-scale prospective studies of vitamin D supplementation in transplant candidates and recipients .
BACKGROUND	Clinicaltrials.gov NCT01175798 .

###24809262
OBJECTIVE	To investigate the timing and value of noninvasive ventilation ( NIV ) as a weaning tool immediately after early extubation in patients with acute respiratory distress syndrome ( ARDS ) .
METHODS	A prospective randomized controlled trial was conducted .
METHODS	The ARDS patients with surgical diseases admitted to Department of Respiratory Intensive Care Unit ( RICU ) of the First Affiliated Hospital of Xinjiang Medical University were enrolled .
METHODS	The patients were randomly divided into sequential group and control group .
METHODS	All patients underwent endotracheal intubation and were mechanically ventilated .
METHODS	Every 12 hours during the first 3 days , the lung recruitment maneuver was performed during pressure control ventilation ( PCV ) .
METHODS	After lung recruitment , all patients were ventilated with synchronized intermittent mandatory ventilation ( SIMV ) + pressure support ventilation ( PSV ) + positive end-expiratory pressure ( PEEP ) or assistant/control ventilation ( A/C ) .
METHODS	The objects in sequential group who met the following criteria including those with oxygen index ( PaO2/FiO2 ) reaching 200-250 mmHg ( 1 mmHg = 0.133 kPa ) under PEEP of 8 cmH2O ( 1 cmH2O = 0.098 kPa ) , and pressure support of 12 cmH2O , and most acute infiltrating lesions having resolved on chest imaging , received noninvasive ventilation ( NIV ) immediately after extubation , and patients in control group continued to have invasive mechanical ventilation via intubation or tracheostomy with an endotracheal tube .
METHODS	The baseline data in both groups and the number of re-intubation in the sequential group were recorded .
METHODS	The duration of invasive mechanical ventilation and total duration of mechanical ventilation , ICU length of stay , the incidence of ventilator-associated pneumonia ( VAP ) , and mortality rate were compared between the two groups .
RESULTS	53 consecutive adult patients were enrolled , including 26 in sequential group and 27 cases in control group .
RESULTS	The period of endotracheal intubation was 7.0 ( 6.8 , 9.5 ) days , and 7.7 % ( 2/26 ) patients underwent re-intubation in sequential group .
RESULTS	There were significant difference in respiratory and circulatory indicators before extubation spontaneous breathing trial ( SBT ) 10 minutes in sequential group , indicating that the patients were still in the early stage of extubation sequential NIV .
RESULTS	There was no significant difference in indices reflecting respiratory function and circulation between the two groups , except that respiratory rate at 1 hour was slightly increased in sequential group as compared with that of control group , indicating that sequential NIV could maintain invasive ventilation function .
RESULTS	There was significant difference in duration of invasive mechanical ventilation [ 7.0 ( 6.8 , 9.5 ) days vs. 21.0 ( 17.0 , 25.0 ) days , Z = -6.048 , P = 0.000 ] , duration of total mechanical ventilation ( 18.04.1 days vs. 22.07.3 days , t = -2.805 , P = 0.008 ) , and length of ICU stay ( 21.04.1 days vs. 28.08.1 days , t = -4.012 , P = 0.000 ) between sequential group and control group , but there was no significant differences in the incidence of VAP [ 15.4 % ( 4/26 ) vs. 29.6 ( 8/27 ) , ( 2 ) = 1.535 , P = 0.215 ] and mortality rate [ 7.7 % ( 2/26 ) vs. 18.5 % ( 5/27 ) , P = 0.420 ] .
CONCLUSIONS	When PaO2/FiO2 reached 200-250 mmHg under the condition of low ventilation , sequential NIV facilitates the early discontinuation of mechanical ventilation in ARDS patients with surgical diseases , with shortening of duration of invasive mechanical ventilation , total mechanical ventilation , and the length of ICU stay .

###25125215
BACKGROUND	Low serum 25-hydroxyvitamin D levels ( 25 ( OH ) D ) have been associated with a higher likelihood of seasonal affective disorder ( SAD ) and poor mental well-being , yet firm evidence for either remains lacking .
BACKGROUND	Thus , vitamin D supplementation may alleviate symptoms associated with SAD .
METHODS	This study was a randomized , single-centre , double-blind , placebo-controlled trial including healthcare professionals employed in psychiatric and somatic hospitals .
METHODS	3345 healthcare professionals were invited to participate , 50 participants were screened , and 34 were able to complete the study .
METHODS	The main inclusion criterion was 8 points or more on question no. 2 of the Seasonal Pattern Assessment Questionnaire ( SPAQ-SAD ) .
METHODS	During a 3-month period , the participants received a daily dose of 70g vitamin D or placebo .
METHODS	The primary outcome was the sum of the self-reported questionnaire Structured Interview Guide for the Hamilton Depression Rating Scale , Seasonal Affective Disorders ( SIGH-SAD ) .
METHODS	The secondary outcome was World Health Organization-Five Well-Being Index ( WHO-5 ) of the healthcare professionals during the winter period and the exploratory outcome measures were weight , waist circumference , blood pressure , absenteeism from work and 25 ( OH ) D.
RESULTS	There were no significant between-group differences in SIGH-SAD sums at 12weeks ( p = 0.7 ( CI : - 3.27 to 4.81 ) ) .
RESULTS	However , there was a significant improvement of primary SIGH-SAD over time from inclusion ( autumn-winter ) to the completion of the study ( winter-spring ) for all participants .
RESULTS	The secondary and exploratory outcome measures were all insignificant between groups.The sums of the SIGH-SAD at 12weeks were not significantly different [ p = 0.701 ( CI : 4.81-3 .27 ) ] between the groups .
RESULTS	There was , however , a significant improvement in primary SIGH-SAD sums over time from inclusion ( autumn-winter ) to the completion of the study ( winter-spring ) in both groups .
RESULTS	The secondary and explorative outcome measures were not significantly different between groups .
CONCLUSIONS	There were no significant between-group differences in the primary ( SIGH-SAD ) and secondary ( WH0-5 ) as well as the exploratory outcome measures ( weight , waist circumference , blood pressure , absenteeism from work and 25 ( OH ) D. Thus , the study failed to demonstrate an effect of vitamin D on SAD symptoms , but our findings may be limited by confounders .
CONCLUSIONS	Furthermore , the study was underpowered and did not allow us to assess the ability of vitamin D to improve mood in those with low 25 ( OH ) D.
BACKGROUND	( http://www.clinicaltrials.gov registration number : NCT01462058 ) .

###24935051
OBJECTIVE	Secondary hyperparathyroidism is a common consequence of chronic kidney disease .
OBJECTIVE	Cinacalcet ( Sensipar ( ) ) is often prescribed in combination to reduce elevated levels of parathyroid hormone , calcium and phosphorus .
OBJECTIVE	The objective of this study was to assess the effects of concomitantly administered therapies of calcium carbonate ( CaCO ( 3 ) ; TUMS ( ) ) , sevelamer hydrochloride ( HCl ; Renagel ( ) ) and pantoprazole sodium ( Protonix ( ) ) on the pharmacokinetics and safety of cinacalcet in healthy subjects .
METHODS	Three randomized , open-label , two-way crossover pharmacokinetic studies were conducted in healthy subjects .
METHODS	Participants received single doses of cinacalcet alone or in combination with either CaCO ( 3 ) , sevelamer HCl or pantoprazole .
METHODS	The pharmacokinetic profile of cinacalcet was characterized .
METHODS	Safety assessments including adverse event reporting , changes in vital signs and clinical laboratory measurements were conducted throughout the studies .
RESULTS	The 90 % confidence intervals for the area under the concentration-time curve from time zero to the last quantifiable concentration ( AUC ( last ) ) , area under the concentration-time curve from time zero to infinity ( AUC ( 0 - ) ) and maximum plasma concentration ( C ( max ) ) of cinacalcet were within the accepted range of 80-125 % for both CaCO ( 3 ) and sevelamer HCl co-administration with cinacalcet .
RESULTS	No severe or serious adverse events or clinically relevant changes in physical or laboratory findings occurred during the studies .
CONCLUSIONS	The pharmacokinetic parameters of cinacalcet were not affected by co-administration of CaCO ( 3 ) , sevelamer HCl or pantoprazole .
CONCLUSIONS	Co-administration of these agents with cinacalcet does not require an adjustment of the dose of cinacalcet .

###25152504
OBJECTIVE	We examined the efficacy of a community-based , culturally relevant intervention to promote healthy eating and physical activity among African American ( AA ) women between the ages of 45-65 years , residing in rural Alabama .
METHODS	We conducted a group randomized controlled trial with counties as the unit of randomization that evaluated two interventions based on health priorities identified by the community : ( 1 ) promotion of healthy eating and physical activity ; and ( 2 ) promotion of breast and cervical cancer screening .
METHODS	A total of 6 counties with 565 participants were enrolled in the study between November 2009 and October 2011 .
RESULTS	The overall retention rate at 24-month follow-up was 54.7 % .
RESULTS	Higher retention rate was observed in the `` healthy lifestyle '' arm ( 63.1 % ) as compared to the `` screening '' arm ( 45.3 % ) .
RESULTS	Participants in the `` healthy lifestyle '' arm showed significant positive changes compared to the `` screening '' arm at 12-month follow-up with regard to decrease in fried food consumption and an increase in both fruit/vegetable intake and physical activity .
RESULTS	At 24-month follow-up , these positive changes were maintained with healthy eating behaviors , but not engagement in physical activity .
CONCLUSIONS	A culturally relevant intervention , developed in collaboration with the target audience , can improve ( and maintain ) healthy eating among AA women living in rural areas .

###25605698
OBJECTIVE	To compare local infiltration of dexamethasone to intravenous injection for postoperative pain and recovery after tonsillectomy .
METHODS	Prospective , randomized study .
METHODS	Second Affiliated Hospital of Harbin Medical University .
METHODS	Children ( n = 240 , American Society of Anesthesiologists [ ASA ] classes I-II , aged 5-10 y ) scheduled for tonsillectomy were randomly and equally assigned to 3 groups : DEX-IV , for intravenous injection of dexamethasone ( 0.5 mg/kg , maximum dose 24 mg ) ; DEX-INF , given the same amount of dexamethasone by local infiltration to the upper middle and lower poles of the tonsils ; and a control group not given dexamethasone .
METHODS	Postoperative pain was scored at intervals from 30 minutes to 24 hours .
METHODS	The time to first administration of analgesic and average consumption of analgesic , times to first oral water and solid food intake , and incidence rates of nausea and vomiting were evaluated .
RESULTS	From postoperative 1 to 16 hours , the DEX-INF group had significantly lower pain scores than did the DEX-IV group , and the time to first analgesic and average consumption of analgesic were also significantly lower .
RESULTS	The times to first oral water and food intake in the DEX-INF group were significantly shorter than in the DEX-IV group .
RESULTS	The incidence of nausea and vomiting in the DEX-INF group was higher than that of the DEX-IV group .
CONCLUSIONS	Local infiltration of dexamethasone was more effective than systemic administration to decrease pain and time to food intake , but the antiemetic effect was less .
BACKGROUND	ChiCTR-TRC-13003535 .

###25655878
BACKGROUND	A vicious circle of decreased physical fitness , early fatigue , and low physical activity levels ( PAL ) is thought to affect children with cerebral palsy ( CP ) .
BACKGROUND	However , the relationship of changes in physical fitness to changes in PAL and fatigue is unclear .
OBJECTIVE	The objective of this study was to investigate the associations among changes in physical fitness , walking-related PAL , and fatigue in children with CP .
METHODS	This study was a secondary analysis of a randomized controlled trial with measurements at baseline , 6 months ( after the intervention period ) , and 12 months .
METHODS	Twenty-four children with bilateral spastic CP and 22 with unilateral spastic CP , aged 7 to 13 years , all walking , participated in this study .
METHODS	Physical fitness was measured by aerobic capacity , anaerobic threshold , anaerobic capacity , and isometric and functional muscle strength .
METHODS	Walking-related PAL was measured using an ankle-worn activity monitor for 1 week .
METHODS	Fatigue was determined with the Pediatric Quality of Life ( PedsQL ) Multidimensional Fatigue Scale .
METHODS	Longitudinal associations were analyzed by random coefficient regression analysis .
RESULTS	In children with bilateral CP , all fitness parameters showed a positive , significant association with walking-related PAL , whereas no associations between physical fitness and walking-related PAL were seen in children with unilateral CP .
RESULTS	No clinically relevant association between physical fitness and fatigue was found .
CONCLUSIONS	Although random coefficient regression analysis can be used to investigate longitudinal associations between parameters , a causal relationship can not be determined .
CONCLUSIONS	The actual direction of the association between physical fitness and walking-related PAL , therefore , remains inconclusive .
CONCLUSIONS	Children with bilateral spastic CP might benefit from improved physical fitness to increase their PAL or vice versa , although this is not the case in children with unilateral CP .
CONCLUSIONS	There appears to be no relationship between physical fitness and self-reported fatigue in children with CP .
CONCLUSIONS	Interventions aimed at improving PAL may be differently targeted in children with either bilateral or unilateral CP .

###24524229
BACKGROUND	Effective interventions to reduce HIV incidence in sub-Saharan Africa are urgently needed .
BACKGROUND	Mathematical modelling and the HIV Prevention Trials Network ( HPTN ) 052 trial results suggest that universal HIV testing combined with immediate antiretroviral treatment ( ART ) should substantially reduce incidence and may eliminate HIV as a public health problem .
BACKGROUND	We describe the rationale and design of a trial to evaluate this hypothesis .
METHODS	A rigorously-designed trial of universal testing and treatment ( UTT ) interventions is needed because : i ) it is unknown whether these interventions can be delivered to scale with adequate uptake ; ii ) there are many uncertainties in the models such that the population-level impact of these interventions is unknown ; and ii ) there are potential adverse effects including sexual risk disinhibition , HIV-related stigma , over-burdening of health systems , poor adherence , toxicity , and drug resistance.In the HPTN 071 ( PopART ) trial , 21 communities in Zambia and South Africa ( total population 1.2 m ) will be randomly allocated to three arms .
METHODS	Arm A will receive the full PopART combination HIV prevention package including annual home-based HIV testing , promotion of medical male circumcision for HIV-negative men , and offer of immediate ART for those testing HIV-positive ; Arm B will receive the full package except that ART initiation will follow current national guidelines ; Arm C will receive standard of care .
METHODS	A Population Cohort of 2,500 adults will be randomly selected in each community and followed for 3 years to measure the primary outcome of HIV incidence .
METHODS	Based on model projections , the trial will be well-powered to detect predicted effects on HIV incidence and secondary outcomes .
CONCLUSIONS	Trial results , combined with modelling and cost data , will provide short-term and long-term estimates of cost-effectiveness of UTT interventions .
CONCLUSIONS	Importantly , the three-arm design will enable assessment of how much could be achieved by optimal delivery of current policies and the costs and benefits of extending this to UTT .
BACKGROUND	ClinicalTrials.gov NCT01900977 .

###25330838
BACKGROUND	Bright light treatment is effective for seasonal affective disorder ( SAD ) , although the mechanisms of action are still unknown .
BACKGROUND	We investigated whether transcranial bright light via the ear canals has an antidepressant effect in the treatment of SAD .
METHODS	During the four-week study period , 89 patients ( 67 females ; 22 males , aged 22-65 , mean SD age : 43.2 10.9 years ) suffering from SAD were randomized to receive a 12-min daily dose of photic energy of one of three intensities ( 1 lumen/0 .72 mW/cm ( 2 ) ; 4 lumens/2 .881 mW/cm ( 2 ) ; 9 lumens/6 .482 mW/cm ( 2 ) ) via the ear canals .
METHODS	The light was produced using light-emitting diodes .
METHODS	The severity of depressive symptoms was assessed with the Hamilton Depression Rating Scale - Seasonal Affective Disorder ( SIGH-SAD ) , the Hamilton Anxiety Rating Scale ( HAMA ) , and the Beck Depression Inventory ( BDI ) .
METHODS	Cognitive performance was measured by the Trail Making Test ( TMT ) .
METHODS	The within-group and between-group changes in these variables throughout the study were analysed with a repeated measures analysis of variance ( ANOVA ) , whereas gender differences at baseline within the light groups were analysed using Student 's t-tests .
RESULTS	Patients in all three groups showed significant decreases in their BDI , HAMA , and SIGH-SAD scores .
RESULTS	Response rates , i.e. , an at least 50 % decrease of symptoms as measured by the BDI , were 74 % -79 % in the three treatment groups .
RESULTS	Corresponding variations for the SIGH-SAD and the HAMA were 35-45 % and 47-62 % , respectively .
RESULTS	No intensity-based dose-response relationships in the improvement of anxiety and depressive symptoms or cognitive performance between treatment groups were observed .
RESULTS	Approximately one in four patients experienced mild adverse effects , of which the most common were headache , insomnia , and nausea .
CONCLUSIONS	These results suggests that transcranial bright light treatment may have antidepressant and anxiolytic effect in SAD patients , as both self - and psychiatrist-rated depressive and anxiety symptoms decreased in all treatment groups .
CONCLUSIONS	These improvements are comparable to findings of earlier bright light studies that used conventional devices .
CONCLUSIONS	The lack of dose response may be due to a saturation effect above a certain light intensity threshold .
CONCLUSIONS	Further studies on the effects of transcranial bright light with an adequate placebo condition are needed .
BACKGROUND	NCT01293409 , ClinicalTrials.gov .

###24513605
OBJECTIVE	Suppressive therapy with levothyroxine is the main step in treatment of differentiated thyroid cancer ( DTC ) .
OBJECTIVE	However , subclinical hyperthyroidism is associated with deleterious effects on cardiovascular and skeletal systems .
OBJECTIVE	Metformin may have a suppressive effect on TSH level .
METHODS	We performed a single blind randomized controlled trial on the effect of short term Metformin therapy on 50 non-diabetic patients with DTC ( mean age of 39.68 8.7 years ) under suppressive therapy with levothyroxine .
METHODS	Metformin ( 500 mg ) or placebo was added to the drug regimen of the patients and levothyroxine dose decreased by 33 % .
METHODS	TSH and thyroid hormone values were measured at the beginning of the study and 3 months after treatment .
RESULTS	Forty-six patients had papillary and 4 had follicular carcinoma .
RESULTS	The mean dose of levothyroxine was 2.20.48 g/kg .
RESULTS	The mean TSH level at the beginning of the study was 0.05.04 mIU/L .
RESULTS	The mean age , weight and baseline TSH level was not significantly different between metformin and placebo groups ( P > 0.2 ) .
RESULTS	In the metformin group , the mean ( SD ) TSH level was significantly increased from 0.030.04 to 3.15.7 mIU/L after 3 months of intervention ( P = 0.01 ) and the mean thyroid hormone levels were significantly decreased ( P < 0.001 ) .
RESULTS	In the placebo group , the mean TSH level increased from 0.040.04 to 3.14.7 mIU/L after 3 months ( P = 0.003 ) .
RESULTS	Delta TSH was 3.05.6 mIU/L and 3.14.7 mIU/L in metformin and placebo groups , respectively ( P = 0.9 ) .
CONCLUSIONS	Adding 500 mg of metformin to drug regimen was not useful to compensate for 33 % of levothyroxine dose reduction in patients with DTC .

###24490628
BACKGROUND	Vocal local ( VL ) is a non-pharmacological pain management technique for gynecological procedures .
BACKGROUND	In Africa , it is usually used in combination with pharmacological analgesics .
BACKGROUND	However , analgesics are associated with side-effects , and can be costly and subject to frequent stock-outs , particularly in remote rural settings .
BACKGROUND	We compared the effectiveness of VL + local anesthesia + analgesics ( the standard approach ) , versus VL + local anesthesia without analgesics , on pain and satisfaction levels for women undergoing tubal ligations in rural Kenya .
METHODS	We conducted a site-randomised non-inferiority trial of 884 women receiving TLs from 40 Marie Stopes mobile outreach sites in Kisii and Machakos Districts .
METHODS	Twenty sites provided VL + local anesthesia + analgesics ( control ) , while 20 offered VL + local anesthesia without additional analgesics ( intervention ) .
METHODS	Pain was measured using a validated 11-point Numeric Rating Scale ; satisfaction was measured using 11-point scales .
RESULTS	A total of 461 women underwent tubal ligations with VL + local anesthesia , while 423 received tubal ligations with VL + local anesthesia + analgesics .
RESULTS	The majority were aged 30 years ( 78 % ) , and had > 3 children ( 99 % ) .
RESULTS	In a multivariate analysis , pain during the procedure was not significantly different between the two groups .
RESULTS	The pain score after the procedure was significantly lower in the intervention group versus the control group ( by 0.40 points ; p = 0.041 ) .
RESULTS	Satisfaction scores were equally high in both groups ; 96 % would recommend the procedure to a friend .
CONCLUSIONS	VL + local anesthesia is as effective as VL + local anesthesia + analgesics for pain management during tubal ligation in rural Kenya .
CONCLUSIONS	Avoiding analgesics is associated with numerous benefits including cost savings and fewer issues related to the maintenance , procurement and monitoring of restricted opioid drugs , particularly in remote low-resource settings where these systems are weak .
BACKGROUND	Pan-African Clinical Trials Registry PACTR201304000495942 .

###24907185
OBJECTIVE	To evaluate the radiation dose , image quality , and influence on visual contrast of low tube voltage abdominal computed tomography ( CT ) and the effects of display setting optimization .
METHODS	One hundred and fifty-seven patients were randomly assigned to one of three protocols .
METHODS	Fifty-two patients underwent a 120 kVp protocol , and 53 and 52 patients underwent low-dose protocols with 100 and 80 kVp , respectively .
METHODS	The effective dose ( ED ) , image noise , CT attenuation , and signal-to-noise ratio ( SNR ) of each organ of each protocol were compared using Dunnett 's test .
METHODS	Qualitative analysis between the protocols was also performed .
RESULTS	The ED of the 100 and 80 kVp protocols were 22 % and 37 % reduced , respectively .
RESULTS	There were no significant differences in the SNR between the protocols ( 120 kVp : 13.8 3.5 ; 100 kVp : 13.9 3.3 ; 80 kVp : 13.5 2.9 ; p > 0.05 ) .
RESULTS	However , there were significant differences in contrast familiarity between the 120 kVp images and all the other images , except 100 kVp images , with optimized display settings ( p < 0.05 ) .
CONCLUSIONS	In abdominal CT , an 80 kVp setting offers greater radiation dose reduction than a 100 kVp setting without significant deterioration of the SNR ; however , the visual contrast between the organs might be changed .

###24493300
OBJECTIVE	Chronic fatigue syndrome ( CFS ) is a disabling condition with unknown disease mechanisms and few treatment options .
OBJECTIVE	To explore the pathophysiology of CFS and assess clonidine hydrochloride pharmacotherapy in adolescents with CFS by using a hypothesis that patients with CFS have enhanced sympathetic activity and that sympatho-inhibition by clonidine would improve symptoms and function .
METHODS	Participants were enrolled from a single referral center recruiting nationwide in Norway .
METHODS	A referred sample of 176 adolescents with CFS was assessed for eligibility ; 120 were included ( 34 males and 86 females ; mean age , 15.4 years ) .
METHODS	A volunteer sample of 68 healthy adolescents serving as controls was included ( 22 males and 46 females ; mean age , 15.1 years ) .
METHODS	The CSF patients and healthy controls were assessed cross-sectionally at baseline .
METHODS	Thereafter , patients with CFS were randomized 1:1 to treatment with low-dose clonidine or placebo for 9 weeks and monitored for 30 weeks ; double-blinding was provided .
METHODS	Data were collected from March 2010 until October 2012 as part of the Norwegian Study of Chronic Fatigue Syndrome in Adolescents : Pathophysiology and Intervention Trial .
METHODS	Clonidine hydrochloride capsules ( 25 g or 50 g twice daily for body weight < 35 kg or > 35 kg , respectively ) vs placebo capsules for 9 weeks .
METHODS	Number of steps per day .
RESULTS	At baseline , patients with CFS had a lower number of steps per day ( P < .001 ) , digit span backward score ( P = .002 ) , and urinary cortisol to creatinine ratio ( P = .001 ) , and a higher fatigue score ( P < .001 ) , heart rate responsiveness ( P = .02 ) , plasma norepinephrine level ( P < .001 ) , and serum C-reactive protein concentration ( P = .04 ) compared with healthy controls .
RESULTS	There were no significant differences regarding blood microbiology evaluation .
RESULTS	During intervention , the clonidine group had a lower number of steps per day ( mean difference , -637 steps ; P = .07 ) , lower plasma norepinephrine level ( mean difference , -42 pg/mL ; P = .01 ) , and lower serum C-reactive protein concentration ( mean ratio , 0.69 ; P = .02 ) compared with the CFS placebo group .
CONCLUSIONS	Adolescent CFS is associated with enhanced sympathetic nervous activity , low-grade systemic inflammation , attenuated hypothalamus-pituitary-adrenal axis function , cognitive impairment , and large activity reduction , but not with common microorganisms .
CONCLUSIONS	Low-dose clonidine attenuates sympathetic outflow and systemic inflammation in CFS but has a concomitant negative effect on physical activity ; thus , sympathetic and inflammatory enhancement may be compensatory mechanisms .
CONCLUSIONS	Low-dose clonidine is not clinically useful in CFS .
BACKGROUND	clinicaltrials.gov Identifier : NCT01040429 .

###25015203
OBJECTIVE	Mature data on tumor control and survival are presented from a randomized trial of the addition of a brachytherapy boost to long-course neoadjuvant chemoradiation therapy ( CRT ) for locally advanced rectal cancer .
METHODS	Between March 2005 and November 2008 , 248 patients with T3-4N0-2M0 rectal cancer were prospectively randomized to either long-course preoperative CRT ( 50.4 Gy in 28 fractions , per oral tegafur-uracil and L-leucovorin ) alone or the same CRT schedule plus a brachytherapy boost ( 10 Gy in 2 fractions ) .
METHODS	The primary trial endpoint was pathologic complete response ( pCR ) at the time of surgery ; secondary endpoints included overall survival ( OS ) , progression-free survival ( PFS ) , and freedom from locoregional failure .
RESULTS	Results for the primary endpoint have previously been reported .
RESULTS	This analysis presents survival data for the 224 patients in the Danish part of the trial .
RESULTS	In all , 221 patients ( 111 control arm , 110 brachytherapy boost arm ) had data available for analysis , with a median follow-up time of 5.4 years .
RESULTS	Despite a significant increase in tumor response at the time of surgery , no differences in 5-year OS ( 70.6 % vs 63.6 % , hazard ratio [ HR ] = 1.24 , P = .34 ) and PFS ( 63.9 % vs 52.0 % , HR = 1.22 , P = .32 ) were observed .
RESULTS	Freedom from locoregional failure at 5 years were 93.9 % and 85.7 % ( HR = 2.60 , P = .06 ) in the standard and in the brachytherapy arms , respectively .
RESULTS	There was no difference in the prevalence of stoma .
RESULTS	Explorative analysis based on stratification for tumor regression grade and resection margin status indicated the presence of response migration .
CONCLUSIONS	Despite increased pathologic tumor regression at the time of surgery , we observed no benefit on late outcome .
CONCLUSIONS	Improved tumor regression does not necessarily lead to a relevant clinical benefit when the neoadjuvant treatment is followed by high-quality surgery .

###24576865
BACKGROUND	The goals of this study were to investigate the difference in responses between a scuba dive preceded by aerobic exercise ( EX ) and a nonexercise control dive ( CON ) and to further evaluate the potential relation between venous gas emboli ( VGE ) and microparticles ( MP ) .
BACKGROUND	We hypothesized that exercise would alter the quantity and subtype of annexin V-positive MP and VGE .
METHODS	Nineteen divers performed two dives to 18 m seawater for 41 min separated by at least 3 d , one of which was preceded by 60 min of treadmill interval exercise .
METHODS	Blood was obtained before exercise , before diving , and 15 min , 2 h , 4 h , and 24 h after surfacing .
METHODS	Intravascular bubbles were quantified by transthoracic echocardiography at 15 , 40 , 80 , and 120 min .
RESULTS	The median VGE remained unchanged between the two dives ; however , there was a significant increase in VGE in the exercise dive at 40 and 80 min at rest .
RESULTS	MP were significantly elevated by approximately 2 times at all time points after CON compared with those after EX .
RESULTS	Markers of neutrophil and platelet activation were elevated by both dives , and these elevations were attenuated in the EX dive .
CONCLUSIONS	We conclude that some of the differences observed between the EX and CON related to MP and platelet and neutrophil activation provide additional insight into the potential protective benefits of exercise ; however , further study is needed to understand the mechanism and true potential of these benefits .

###24401214
OBJECTIVE	Although previous randomized clinical trials established a basis for lipid guidelines worldwide , they employed fixed doses of statins throughout trials ( fire-and-forget approach ) .
OBJECTIVE	In the real clinical setting , however , statin doses are titrated to achieve target low-density lipoprotein cholesterol ( LDL-C ) levels ( treat-to-target approach ) .
OBJECTIVE	The major objective was to investigate whether intensive lipid-lowering therapy using the treat-to-target approach yielded greater regression of aortic plaques .
METHODS	We therefore performed a prospective , randomized trial comparing the effects of standard ( achieve LDL-C levels recommended by the Japanese guidelines ) and intensive ( achieve 30 % lower LDL-C levels than standard ) rosuvastatin therapy for 1 year in 60 hypercholesterolemic patients with a primary endpoint of aortic atherosclerotic plaques evaluated by non-invasive magnetic resonance imaging ( MRI ) .
RESULTS	Average doses were 2.9 3.1 and 6.5 5.1 mg/day for standard ( n = 29 ) and intensive therapy group ( n = 31 ) , respectively .
RESULTS	Although both therapies significantly reduced LDL-C and high-sensitivity C-reactive protein ( hsCRP ) levels , LDL-C reduction was significantly greater in the intensive group ( -46 vs. -34 % ) .
RESULTS	MRI study showed that thoracic aortic plaques were significantly regressed in both groups , with greater regression of thoracic plaque in the intensive group ( -9.1 vs. -3.2 % , p = 0.01 ) .
RESULTS	Multivariate analyses revealed that thoracic plaque regression was significantly correlated with hsCRP reduction , but not with changes in serum lipids , endothelial function , or doses of rosuvastatin .
CONCLUSIONS	Intensive statin therapy with titration targeting lower LDL-C levels resulted in greater thoracic aortic plaque regression compared to standard therapy , which was correlated with hsCRP reduction , suggesting that intensive statin therapy could provide better clinical outcomes .

###24662499
OBJECTIVE	To evaluate the efficacy and tolerability of pregabalin in postoperative pain management after laparoscopic cholecystectomy ( LC ) .
METHODS	A prospective , randomized , placebo , controlled , double-blinded study was conducted at Anesthesia Department , Laparoscopy Surgery Unit , Ain Shams University Hospital .
METHODS	Ninety patients with ASA physical status I-II scheduled for elective LC under general anesthesia were included .
METHODS	Patients were randomly assigned to the following groups ( n = 30 each ) : pregabalin group ( P ) , received 150 mg pregabalin capsules 2 hours preoperatively , 12 hours postoperatively , and twice daily for 2 days ; gabapentin group ( G ) , received 1200 mg gabapentin capsules ( 400 mg , 3 ) 2 hours preoperatively , 12 hours postoperatively , and 400 mg three times daily for 2 days ; and control group ( C ) , received placebo capsules .
METHODS	Postoperative pain scores were recorded on a visual analogue scale .
METHODS	The following data were recorded : total daily pethidine and diclofenac consumption , numeric sedation score , and the postoperative nausea , vomiting , and dizziness scores .
RESULTS	The 24-hour pethidine consumption was significantly lower ( P < 0.001 ) in both pregabalin and gabapentin groups versus control .
RESULTS	Both groups had significantly less ( P < 0.001 ) patients with postoperative nausea , vomiting , sedation , and dizziness versus control .
RESULTS	Overall patient satisfaction with pain management was significantly higher ( P < 0.001 ) in pregabalin group versus gabapentin or control groups .
CONCLUSIONS	Gabapentin 1200 mg and pregabalin 150 mg are effective and safe analgesics for reducing postoperative pain in LC .
CONCLUSIONS	The perioperative oral administration of pregabalin 150 mg in patients undergoing LC is an effective and safe method of analgesia with a low incidence of adverse effects and reduces postoperative pethidine consumption .

###24689246
OBJECTIVE	The aim of the study was to investigate the influence of different driving scenarios ( urban , rural , highway ) on the timing required by drivers from a two-stage warning system , based on car-to-car communication .
BACKGROUND	Car-to-car communication systems are designed to inform drivers of potential hazards at an early stage , before they are visible to them .
BACKGROUND	Here , questions arise as to how drivers acknowledge early warnings and when they should be informed ( first stage ) and warned ( second stage ) .
BACKGROUND	Hence , optimum timing for presenting the information was tested .
METHODS	A psychophysical method was used to establish the optimum timing in three driving scenarios at different speed limits ( urban : 50 km/h , rural : 100 km/h , highway : 130 km/h ) .
METHODS	A total of 24 participants ( 11 female , 13 male ; M = 29.1 years , SD = 11.6 years ) participated in the study .
RESULTS	The results showed that the optimum timing did not differ among the three scenarios.The first and second stages should ultimately be presented at different timings at each speed limit ( first stage : 26.5 s , second stage : 12.1 s before a potential hazard ) .
CONCLUSIONS	The results showed that well-selected timing for activating information and warning is crucial for the acceptance of these systems .
CONCLUSIONS	Appropriate timing for presenting the information and warning can be derived for these systems .
CONCLUSIONS	The findings will be integrated in further development of assistance systems based on car-to-x technology within the Car2X-Safety project of the Niederschsisches Forschungszentrum Fahrzeugtechnik in Germany.This study was also supported by Chalmers University of Technology in Sweden .

###25012121
BACKGROUND	Conducting randomized controlled trials on traditional Chinese non-drug therapies has been limited by factors such as patient preference to specific treatment modality .
BACKGROUND	The aim of this study is to investigate the feasibility of applying a partially randomized patient preference ( PRPP ) trial model in evaluating the efficacy of two types of traditional Chinese medicine therapies , acupuncture and cupping , for fibromyalgia while accounting for patients ' preference of either therapeutic modality .
METHODS	This protocol was approved by the Institutional Ethics Committee of affiliated Dongfang Hospital , Beijing University of Chinese Medicine ( approval number : 2013052104-2 ) .
METHODS	One hundred participants with fibromyalgia will be included in this study .
METHODS	Diagnosis of fibromyalgia will be based on the American College of Rheumatology criteria .
METHODS	Before treatment , participants will be interviewed for their preference toward acupuncture or cupping therapy .
METHODS	Fifty participants with no preference will be randomly assigned to one of the two groups and another 50 participants with strong preference to either acupuncture or cupping will receive what they choose .
METHODS	For acupuncture and cupping therapy , the main acupoints used will be tender points ( Ashi ) .
METHODS	Treatment will be three times a week for 5 consecutive weeks with a follow-up period of 12weeks .
METHODS	Outcome measures will be qualitative ( patient expectation and satisfaction ) and quantitative ( pain intensity , quality of life , depression assessment ) .
BACKGROUND	NCT01869712 ( in clinicaltrials.gov , on 22nd May 2013 ) .

###25092211
OBJECTIVE	Adequate postoperative analgesia may enhance recovery .
OBJECTIVE	The efficacy of continuous wound infusion vs intermittent epidural ropivacaine for postoperative analgesia was investigated .
METHODS	Prospective randomized , observer blind trial .
METHODS	Aretaieio University Hospital .
METHODS	Patients scheduled for open abdominal hysterectomy or myomectomy .
METHODS	Patients received 10 mL of 0.75 % ropivacaine along the skin incision before skin closure , followed by wound infusion 2 mL/hour of 0.375 % ropivacaine or epidurally 10 mL of 0.75 % ropivacaine in the beginning of surgery followed by 10 mL of 0.2 % ropivacaine 6 hourly .
METHODS	The epidural injections or the wound infusion of ropivacaine lasted 48 hours .
METHODS	Rescue analgesia consisted of patient-controlled analgesia morphine up to 48 hours and acetaminophen/codeine tablets the next 24 hours .
METHODS	Analgesic consumption and visual analog scale pain at rest and during cough were assessed 2 , 4 , 8 , 24 , 48 , and 72 hours postoperatively .
METHODS	One and three months later , patients were interviewed by phone for analgesic consumption at home and presence of pain .
RESULTS	The subcutaneous group consumed more morphine during the first 2 , 4 , and 8 hours postoperatively ( P < 0.001 , P < 0.001 , and P < 0.001 , respectively ) .
RESULTS	Subsequent morphine and acetaminophen/codeine requirements did not differ between the two groups .
RESULTS	Pain intensity during cough was higher only 2 hours after surgery in the subcutaneous group ( P = 0.002 ) .
RESULTS	Three months postoperatively , the two groups did not differ in the analgesic requirements and presence of persisting and/or burning pain .
CONCLUSIONS	Based on our results , there is no clinical significant difference between the epidural ropivacaine and the subcutaneous ropivacaine group or a clear superiority to one management strategy .

###25707085
OBJECTIVE	An 18-month randomized , controlled prospective study evaluated , in an intra-individual comparison , the clinical performance of two-step etch-and-rinse adhesives in non-carious cervical lesions ( NCCL ) .
METHODS	35 subjects , with at least two similar sized NCCL participated in this study .
METHODS	After sample size calculation , 70 restorations were placed , according to one of the following groups : Adper Single Bond 2 ( SB ) and Ambar ( AM ) .
METHODS	The restorations were placed incrementally using a resin composite ( Opallis ) .
METHODS	The restorations were evaluated at baseline and after 6 and 18 months according to the FDI criteria .
METHODS	The differences in the ratings of the two materials after 6 and 18 months were tested with Fisher 's exact test ( = 0.05 ) , and the performance of the each material at baseline and after 6 and 18 months was evaluated by Wilcoxon test ( = 0.05 ) .
RESULTS	All subjects attended the 18-month recall .
RESULTS	No significant differences were observed between the materials for any criteria evaluated .
RESULTS	Only four restorations ( two from each material ) were lost after 18 months .
RESULTS	Thus , the retention rates of both materials at 18 months were 94.2 % ( 95 % CI 81-98 % ) .
RESULTS	Nine restorations ( four Ambar and five Adper Single Bond 2 ) showed marginal discoloration which was solved with a polishing procedure .
RESULTS	Both adhesive systems showed acceptable clinical retention rates after 18 months .

###24690184
BACKGROUND	The leading mental health causes of the global burden of disease are depression in women and alcohol use disorders in men .
BACKGROUND	A major hurdle to the implementation of evidence-based psychological treatments in primary care in developing countries is the non-availability of skilled human resources .
BACKGROUND	The aim of these trials is to evaluate the effectiveness and cost-effectiveness of two psychological treatments developed for the treatment of depression and alcohol use disorders in primary care in India .
METHODS	This study protocol is for parallel group , randomized controlled trials ( Healthy Activity Program for moderate to severe depression , Counselling for Alcohol Problems for harmful and dependent drinking ) in eight primary health centres in Goa , India .
METHODS	Adult primary care attendees will be screened with the Patient Health Questionnaire for depression and , in men only , the Alcohol Use Disorders Identification Test for drinking problems .
METHODS	Screen-positive attendees will be invited to participate ; men who screen positive for both disorders will be invited to participate in the Counselling for Alcohol Problems trial .
METHODS	Those who consent will be allocated in a 1:1 ratio to receive either the respective psychological treatment plus enhanced usual care or enhanced usual care only using a computer generated allocation sequence , stratified by primary health centre and , for depression , by sex .
METHODS	The enhanced usual care comprises providing primary health centre doctors with contextualized World Health Organization guidelines and screening results .
METHODS	Psychological treatments will be delivered by lay counsellors , over a maximum period of three months .
METHODS	Primary outcomes are severity of disorder and remission rates at three months post-enrolment and , for the Counselling for Alcohol Problems trial , drinking and the impact of drinking on daily lives .
METHODS	Secondary outcomes include severity of disorder and remission rates at 12months , disability scores , suicidal behaviour and economic impact , and cost-effectiveness at three and 12months .
METHODS	500 participants with depression and 400 participants with harmful drinking will be recruited .
METHODS	Primary analyses will be intention-to-treat .
CONCLUSIONS	These trials may offer a new approach for the treatment of moderate-severe depression and drinking problems in primary care that is potentially scalable as it relies on delivery by a single pool of lay counsellors .
BACKGROUND	Both trials are registered with the International Society for the Registration of Clinical Trials ( Healthy Activity Programme registration number ISRCTN95149997 ; Counselling for Alcohol Problems registration number ISRCTN76465238 ) .

###25028911
OBJECTIVE	To compare WHO first-line antiretroviral therapy ( ART ) with nonnucleoside reverse transcriptase inhibitors ( NNRTI ) - based regimen with a boosted protease inhibitor ( bPI ) regimen in a resource-limited setting regarding treatment outcome and emergence of drug resistance mutations ( DRMs ) .
METHODS	Treatment-naive adults were randomized to nevirapine ( NVP ) or ritonavir-boosted lopinavir ( LPV/r ) regimens each in combination with tenofovir ( TDF ) / emtricitabine ( FTC ) or zidovudine ( ZDV ) / lamivudine ( 3TC ) .
METHODS	Primary endpoint was the incidence of therapeutical ( clinical and/or virologic ) failure at week 48 with follow-up till week 96 .
RESULTS	Four hundred and twenty-five patients ( 120 men ; 305 women ) received at least one dose of the study drug .
RESULTS	mITT analysis showed no difference in proportion of therapeutical failure between treatment arms [ 67/209 ( 32 % ) in NVP vs. 63/216 ( 29 % ) LPV/r at week 48 ( P = 0.53 ) ; 88/209 ( 42 % ) in NVP vs. 83/216 ( 38 % ) in LPV/r at week 96 ( P = 0.49 ) ] .
RESULTS	Per-protocol analysis demonstrated significantly more virologic failure with NVP than with LPV/r regimens [ at week 48 : 19/167 ( 11 % ) vs. 7/166 ( 4 % ) , P = 0.014 ; at week 96 : 27/158 ( 17 % ) vs. 13/159 ( 8 % ) , P = 0.019 ) ] .
RESULTS	Drug resistance mutations to NNRTI were detected in 19 out of 22 ( 86.3 % ) and dual-class resistance to nucleoside reverse transcriptase inhibitor ( NRTI ) and NNRTI in 15 out of 27 ( 68.2 % ) of NVP failing patients .
RESULTS	K65R mutation was present in seven out of 14 patients failing NVP-TDF/FTC regimen .
RESULTS	No major protease inhibitor-DRM was detected among LPV/r failing patients .
RESULTS	Discontinuation for adverse events was similar between treatment groups .
CONCLUSIONS	In resource-limited settings , first-line NNRTI-NRTI regimen as compared with bPI-based regimen provides similar outcome but is associated with a significantly higher number of virologic failure and resistance mutations in both classes that jeopardize future options for second-line therapy .

###26356162
OBJECTIVE	We carried out an open randomized controlled study to explore the changes in the rate of speech recovery and BDNF concentrations in patients with left-hemisphere stroke and carbohydrate metabolism disorders ( diabetes mellitus type2 or prediabetes ) who received cerebrolysin .
METHODS	A study included 60 inpatients of the Center of Speech Pathology and Neurorehabilitation .
METHODS	Neuropsychological examination was performed at baseline and after the treatment was completed .
METHODS	We determined aphasia type and quantitatively assessed speech in scores which reflected the severity of speech impairment .
METHODS	BDNF serum concentrations were measured .
RESULTS	Clinical efficacy of cerebrolysin ( intravenously in dose 20 ml in 100 ml of physiological solution , 5 days a week , during 4 weeks ) used in addition to standard neurorehabilitation measures in patients with post stroke aphasia of different severity was demonstrated .
RESULTS	This treatment was most effective in patients with very marked and marked speech impairment that was confirmed by the maximal possible improvement of speech during the first course of neurorehabilitation measures , in particular in a subgroup of patients without carbohydrate metabolism disorders .
RESULTS	A significant increase in BDNF concentrations was an additional evidence of this improvement .
CONCLUSIONS	The use of cerebrolysin in the complex treatment of patients with post stroke aphasia of different severity improves the prognosis of their rehabilitation .

###24369114
BACKGROUND	Although repeat radiation treatment has been shown to palliate pain in patients with bone metastases from multiple primary origin sites , data for the best possible dose fractionation schedules are lacking .
BACKGROUND	We aimed to assess two dose fractionation schedules in patients with painful bone metastases needing repeat radiation therapy .
METHODS	We did a multicentre , non-blinded , randomised , controlled trial in nine countries worldwide .
METHODS	We enrolled patients 18 years or older who had radiologically confirmed , painful ( ie , pain measured as 2 points using the Brief Pain Inventory ) bone metastases , had received previous radiation therapy , and were taking a stable dose and schedule of pain-relieving drugs ( if prescribed ) .
METHODS	Patients were randomly assigned ( 1:1 ) to receive either 8 Gy in a single fraction or 20 Gy in multiple fractions by a central computer-generated allocation sequence using dynamic minimisation to conceal assignment , stratified by previous radiation fraction schedule , response to initial radiation , and treatment centre .
METHODS	Patients , caregivers , and investigators were not masked to treatment allocation .
METHODS	The primary endpoint was overall pain response at 2 months , which was defined as the sum of complete and partial pain responses to treatment , assessed using both Brief Pain Inventory scores and changes in analgesic consumption .
METHODS	Analysis was done by intention to treat .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00080912 .
RESULTS	Between Jan 7 , 2004 , and May 24 , 2012 , we randomly assigned 425 patients to each treatment group .
RESULTS	19 ( 4 % ) patients in the 8 Gy group and 12 ( 3 % ) in the 20 Gy group were found to be ineligible after randomisation , and 140 ( 33 % ) and 132 ( 31 % ) patients , respectively , were not assessable at 2 months and were counted as missing data in the intention-to-treat analysis .
RESULTS	In the intention-to-treat population , 118 ( 28 % ) patients allocated to 8 Gy treatment and 135 ( 32 % ) allocated to 20 Gy treatment had an overall pain response to treatment ( p = 021 ; response difference of 400 % [ upper limit of the 95 % CI 92 , less than the prespecified non-inferiority margin of 10 % ] ) .
RESULTS	In the per-protocol population , 116 ( 45 % ) of 258 patients and 134 ( 51 % ) of 263 patients , respectively , had an overall pain response to treatment ( p = 017 ; response difference 600 % [ upper limit of the 95 % CI 132 , greater than the prespecified non-inferiority margin of 10 % ] ) .
RESULTS	The most frequently reported acute radiation-related toxicities at 14 days were lack of appetite ( 201 [ 56 % ] of 358 assessable patients who received 8 Gy vs 229 [ 66 % ] of 349 assessable patients who received 20 Gy ; p = 0011 ) and diarrhoea ( 81 [ 23 % ] of 357 vs 108 [ 31 % ] of 349 ; p = 0018 ) .
RESULTS	Pathological fractures occurred in 30 ( 7 % ) of 425 patients assigned to 8 Gy and 20 ( 5 % ) of 425 assigned to 20 Gy ( odds ratio [ OR ] 154 , 95 % CI 085-275 ; p = 015 ) , and spinal cord or cauda equina compressions were reported in seven ( 2 % ) of 425 versus two ( < 1 % ) of 425 , respectively ( OR 354 , 95 % CI 073-1715 ; p = 0094 ) .
CONCLUSIONS	In patients with painful bone metastases requiring repeat radiation therapy , treatment with 8 Gy in a single fraction seems to be non-inferior and less toxic than 20 Gy in multiple fractions ; however , as findings were not robust in a per-protocol analysis , trade-offs between efficacy and toxicity might exist .
BACKGROUND	Canadian Cancer Society Research Institute , US National Cancer Institute , Cancer Council Australia , Royal Adelaide Hospital , Dutch Cancer Society , and Assistance Publique-Hpitaux de Paris .

###24671858
OBJECTIVE	The combination of midazolam and opioid has been widely used as a standard sedative regimen for endoscopic retrograde cholangiopancreatography ( ERCP ) .
OBJECTIVE	Following recent evidence that dexmedetomidine may exert a synergistic effect in combination with midazolam , this study compared the sedative effect and adverse events of midazolam-meperidine-dexmedetomidine ( MMD ) and midazolam-meperidine during ERCP .
METHODS	A total of 110 patients who were scheduled for ERCP were prospectively enrolled and randomly assigned , in a double-blind manner , to the MMD ( n = 53 ) or midazolam-meperidine ( n = 57 ) groups .
METHODS	Each patient received an intravenous ( IV ) bolus dose of midazolam and meperidine ( 0.06 mg/kg and 50mg , 30 % reduction and 25mg for patients aged 65 years , respectively ) .
METHODS	To this dose , a continuous IV infusion of dexmedetomidine ( 1g/kg/h ; MMD group ) or the same volume of normal saline ( midazolam-meperidine group ) was added .
METHODS	The sedation level ( Ramsay Sedation Scale [ RSS ] ) as well as hemodynamic and respiratory changes were assessed .
RESULTS	Adequate sedation ( RSS3 ) was maintained during ERCP in 75.5 % and 36.8 % of the MMD and midazolam-meperidine group , respectively ( P < 0.001 ) .
RESULTS	RSS scores were significantly higher in the MMD group ( P < 0.001 ) .
RESULTS	Intraoperative bispectral index scores were significantly lower in the MMD group ( P < 0.001 ) than in the midazolam-meperidine group.Lower additional ( P = 0.001 ) and total ( P = 0.003 ) doses of midazolam were required in the MMD group.Patients in the MMD group showed lower pain scores ( P < 0.001 ) and higher satisfaction scores ( P < 0.001 ) .
RESULTS	Desaturation occurred more frequently in the midazolam-meperidine group ( 11 vs. 1 ; P = 0.003 ) .
CONCLUSIONS	The addition of dexmedetomidine to the midazolam-meperidine regimen provided better sedative efficacy and a superior safety profile during ERCP compared with a midazolam-meperidine regimen.This trial was registered at ClinicalTrials.gov Identifier ( NCT01404689 ) .

###25124733
BACKGROUND	The transient receptor potential vanilloid 1 has been implicated as a target mediator for heartburn perception and modulation of esophageal secondary peristalsis .
BACKGROUND	Our aim was to determine the effect of repeated esophageal infusion of capsaicin-contained red pepper sauce on heartburn perception and secondary peristalsis in healthy adults .
METHODS	Secondary peristalsis was performed with mid-esophageal injections of air in 15 healthy adults .
METHODS	Two separate protocols including esophageal infusion with saline and capsaicin-contained red pepper sauce and 2 consecutive sessions of capsaicin-contained red pepper sauce were randomly performed .
RESULTS	After repeated infusion of capsaicin-contained red pepper sauce , the threshold volume to activate secondary peristalsis was significantly increased during slow ( p < 0.001 ) and rapid air injections ( p = 0.004 ) .
RESULTS	Acute infusion of capsaicin-contained red pepper sauce enhanced heartburn perception ( p < 0.001 ) , but the intensity of heartburn perception was significantly reduced after repeated capsaicin-contained red pepper sauce infusion ( p = 0.007 ) .
RESULTS	Acute infusion of capsaicin-contained red pepper sauce significantly increased pressure wave amplitudes of distal esophagus during slow ( p = 0.003 ) and rapid air injections ( p = 0.01 ) , but repeated infusion of capsaicin-contained red pepper sauce significantly decreased pressure wave amplitude of distal esophagus during slow ( p = 0.0005 ) and rapid air injections ( p = 0.003 ) .
CONCLUSIONS	Repeated esophageal infusion of capsaicin appears to attenuate heartburn perception and inhibit distension-induced secondary peristalsis in healthy adults .
CONCLUSIONS	These results suggest capsaicin-sensitive afferents in modulating sensorimotor function of secondary peristalsis in human esophagus .

###26442394
BACKGROUND	This study was conducted to determine if intravenous dexamethasone combined with caudal block was able to prolong post-operative analgesia in pediatric daycare surgeries .
METHODS	Sixty four ASA I or II children aged 3 to 10 year old scheduled for daycare open unilateral herniotomy received general anesthesia and caudal block using 0.25 % levobupivacaine 0.75 mg.kg ( -1 ) with suppository paracetamol 30 mg.kg ( -1 ) .
METHODS	After anesthesia induction , they were randomized to receive either intravenous dexamethasone 0.5 mg.kg ( -1 ) ( Group I ) or same volume intravenous normal saline ( Group II ) .
METHODS	Postoperatively , pain scores were assessed using Wong - Baker faces scale .
METHODS	At home , their parents assessed and recorded the pain scores , time to first oral paracetamol served and frequency of paracetamol given in two consecutive days post surgery .
METHODS	On the third postoperative day , these information were gathered from the parents via a phone call .
RESULTS	There were statistically significant differences between Group I and Group II in the median time to first paracetamol ( 800 vs 520 min , p = 0.01 ) , mean pain scores postoperative day 1 ( 1.9 2.0 vs 3.5 2.2 , p = 0.05 ) , mean pain score-postoperative day 2 ( 0.8 1.6 vs 2.3 2.0 , p = 0.03 ) and mean frequencies of paracetamol given on postoperative day 2 ( 0.3 0.8 vs 1.1 1.0 , p = 0.02 ) .
CONCLUSIONS	A single intravenous dexamethasone dose when combined with caudal block reduces postoperative pain , decreases paracetamol requirement and prolongs analgesic duration in children after open herniotomy .

###25234941
OBJECTIVE	The liver is an important organ for various aspects of glucose metabolism , including glucose uptake , storage , and synthesis .
OBJECTIVE	It is a major organ in the metabolic process with perfusion provided by both the portal vein and hepatic artery .
OBJECTIVE	In diabetic patients organ perfusion is reduced and this is linked to atherosclerosis , and as a result complications occur .
OBJECTIVE	In this study , we aimed to evaluate liver perfusion by scintigraphic methods in diabetic patients .
METHODS	We retrospectively investigated 1,100 myocardial perfusion scintigraphies taken between January 2011 and December 2012 at Canakkale Onsekiz Mart University Medical Faculty Nuclear Medicine Department .
METHODS	A total of 66 patients who were diagnosed with diabetes mellitus and had myocardial perfusion scintigraphies were included in the study .
METHODS	The control subjects included 127 patients without diabetes mellitus who were chosen at random .
METHODS	Patients with chronic liver disease were not included in the study .
METHODS	The values from liver regions of interest ( liver-ROI ) rates and heart regions of interest ( heart-ROI ) rates were compared between the patients and controls .
RESULTS	Patients were grouped according to the presence of diabetes .
RESULTS	In the diabetes mellitus group , the liver-ROI average was lower ( p = 0.66 ) than in the controls .
RESULTS	In the control group , the average liver-ROI/heart-ROI ratios were higher than the ratio in the diabetes mellitus group ( p = 0.019 ) .
RESULTS	Multivariate variance analysis showed that the diabetes mellitus liver-ROI/heart-ROI ratio was independent of other risk factors ( p = 0.003 ; F : 9.6 ) .
RESULTS	Powered by Editorial Manager ( ) and ProduXion Manager ( ) from Aries Systems Corporation .
CONCLUSIONS	This study shows that liver perfusion in diabetic patients is reduced compared with those without diabetes .
CONCLUSIONS	Prospective studies with larger patient groups are required .

###24812434
OBJECTIVE	There is no consensus on the importance of visit-to-visit glycemic variability in diabetes .
OBJECTIVE	Therefore , we assessed the effects of visit-to-visit variability ( VVV ) in HbA1c and fasting glucose on major outcomes in the ADVANCE ( Action in Diabetes and Vascular Disease : Preterax and Diamicron MR Controlled Evaluation ) trial .
METHODS	ADVANCE was a factorial randomized controlled trial of intensive glucose control and blood pressure lowering in patients with type 2 diabetes .
METHODS	VVV in the intensive glucose treatment group was defined using the SD of five measurements of HbA1c and glucose taken 3-24 months after randomization .
METHODS	Outcomes were combined macro - and microvascular events and all-cause mortality occurring post 24 months .
METHODS	Sensitivity analyses were performed using other indices of variability and in the standard glucose treatment group .
RESULTS	Among 4,399 patients in the intensive group , an increase in VVV of HbA1c was associated with an increased risk of vascular events ( P = 0.01 ) and with mortality ( P < 0.001 ) : highest versus lowest tenth hazard ratio ( 95 % CI ) 1.64 ( 1.05-2 .55 ) and 3.31 ( 1.57-6 .98 ) , respectively , after multivariable adjustment .
RESULTS	A clear association was also observed between VVV of fasting glucose and increased risk of vascular events ( P < 0.001 ; 2.70 [ 1.65-4 .42 ] ) .
RESULTS	HbA1c variability was positively associated with the risk of macrovascular events ( P = 0.02 for trend ) , whereas glucose variability was associated with both macro - and microvascular events ( P = 0.005 and P < 0.001 for trend , respectively ) .
RESULTS	Sensitivity analyses using other indices , and patients in the standard glucose treatment group , were broadly consistent with these results .
CONCLUSIONS	Consistency of glycemic control is important to reduce the risks of vascular events and death in type 2 diabetes .

###24886287
BACKGROUND	Insulin initiation and titration in primary care is necessary to respond to the growing epidemic of type 2 diabetes ( T2D ) .
BACKGROUND	The INITIATION study aims to evaluate the impact of implementing a new model of care with Primary Care Physician and Practice Nurse ( PN ) teams supported by a Credentialed Diabetes Educator-Registered Nurse ( CDE-RN ) and endocrinologist in initiating and titrating basal and prandial insulin for T2D patients in the Australian healthcare system over 24weeks .
BACKGROUND	This study also explores the feasibility and efficacy of retrospective continuous glucose monitoring ( r-CGM ) in comparison with self-monitoring of blood glucose ( SMBG ) among people with T2D in primary care .
METHODS	The study employs a before and after design with a nested exploratory trial of SMBG and r-CGM .
METHODS	A total of 102 insulin nave T2D patients with a glycated haemoglobin ( HbA1c ) level of > 7.5 % in the previous 6months while treated with maximal oral therapy will be recruited and screened from 22 primary care practices in Melbourne , Australia .
METHODS	All patients will be commenced on a basal insulin regimen following randomization into one of the two blood glucose monitoring arms , with intensification to a `` basal plus '' regimen if required .
METHODS	The outcomes of the new model of care will be benchmarked with data collected over the same period from a specialist setting in Melbourne , Australia .
CONCLUSIONS	This article describes the study protocol and insulin treatment algorithm employed in the first study to explore r-CGM use among T2D in primary care .
CONCLUSIONS	Findings from the INITIATION study will inform development of a larger randomized controlled trial .
BACKGROUND	ACTRN12610000797077 .

###24490841
BACKGROUND	Integrative neuromuscular training ( INT ) has successfully enhanced physical fitness and reduced abnormal biomechanics , which appear to decrease injury rates in adolescent female athletes .
BACKGROUND	If not addressed at the proper time , low levels of physical fitness and abnormal mechanics may predispose female athletes to an increased risk of musculoskeletal injuries .
OBJECTIVE	To evaluate sex-specific effects of INT on selected measures of health - and skill-related fitness in children during physical education ( PE ) .
METHODS	Cohort study .
METHODS	Public primary school .
METHODS	Forty children ( 16 boys , 24 girls ; age = 7.6 0.3 years , height = 124.5 6.4 cm , mass = 29.5 7.6 kg ) from 2 second-grade PE classes .
METHODS	The classes were randomized into the PE-plus-INT group ( 10 boys , 11 girls ) or the control group ( 6 boys , 13 girls ) that participated in traditional PE .
METHODS	The INT was performed 2 times per week during the first approximately 15 minutes of each PE class and consisted of body weight exercises .
METHODS	Push-up , curl-up , standing long jump , single-legged hop , single-legged balance , sit-and-reach flexibility test , shuttle run , and 0.8-km run .
RESULTS	At baseline , the boys demonstrated higher levels of performance in most of the fitness measurements as evidenced by greater performance on the push-up , standing long jump , single-legged hop , shuttle run , and 0.8-km run ( P < .05 ) .
RESULTS	In the evaluation of the training effects , we found intervention effects in the girls for enhanced INT-induced gains in performance relative to the control group on the curl-up , long jump , single-legged hop , and 0.8-km run ( P < .05 ) after controlling for baseline .
RESULTS	Boys did not demonstrate similar adaptations from the INT program ( P .05 ) .
CONCLUSIONS	These data indicate that INT is an effective and time-efficient addition to PE for enhancing motor skills and promoting physical activity in children .
CONCLUSIONS	Seven-year-old girls appeared to be more sensitive to the effects of INT than 7-year-old boys .
CONCLUSIONS	Future research is warranted to confirm these effects in larger cohorts of children .

###26150052
OBJECTIVE	To evaluate ranibizumab 0.5 mg using bimonthly monitoring and individualized re-treatment after monthly follow-up for 6 months in patients with visual impairment due to diabetic macular edema ( DME ) .
METHODS	A phase IIIb , 18-month , prospective , open-label , multicenter , single-arm study in the United Kingdom .
METHODS	Participants ( N = 109 ) with visual impairment due to DME .
METHODS	Participants received 3 initial monthly ranibizumab 0.5 mg injections ( day 0 to month 2 ) , followed by individualized best-corrected visual acuity ( BCVA ) and optical coherence tomography-guided re-treatment with monthly ( months 3-5 ) and subsequent bimonthly follow-up ( months 6-18 ) .
METHODS	Laser was allowed after month 6 .
METHODS	Mean change in BCVA from baseline to month 12 ( primary end point ) , mean change in BCVA and central retinal thickness ( CRT ) from baseline to month 18 , gain of 10 and 15 letters , treatment exposure , and incidence of adverse events over 18 months .
RESULTS	Of 109 participants , 100 ( 91.7 % ) and 99 ( 90.8 % ) completed the 12 and 18 months of the study , respectively .
RESULTS	The mean age was 63.7 years , the mean duration of DME was 40 months , and 77.1 % of the participants had received prior laser treatment ( study eye ) .
RESULTS	At baseline , mean BCVA was 62.9 letters , 20 % of patients had a baseline BCVA of > 73 letters , and mean baseline CRT was 418.1 m , with 32 % of patients having a baseline CRT < 300 m.
RESULTS	The mean change in BCVA from baseline to month 6 was +6.6 letters ( 95 % confidence interval [ CI ] , 4.9-8 .3 ) , and after institution of bimonthly treatment the mean change in BCVA at month 12 was +4.8 letters ( 95 % CI , 2.9-6 .7 ; P < 0.001 ) and +6.5 letters ( 95 % CI , 4.2-8 .8 ) at month 18 .
RESULTS	The proportion of participants gaining 10 and 15 letters was 24.8 % and 13.8 % at month 12 and 34.9 % and 19.3 % at month 18 , respectively .
RESULTS	Participants received a mean of 6.8 and 8.5 injections over 12 and 18 months , respectively .
RESULTS	No new ocular or nonocular safety findings were observed during the study .
CONCLUSIONS	The BCVA gain achieved in the initial 6-month treatment period was maintained with an additional 12 months of bimonthly ranibizumab PRN treatment .

###24397906
BACKGROUND	The highest risk for invasive meningococcal disease ( IMD ) is in infants aged < 1 year .
BACKGROUND	Quadrivalent meningococcal conjugate vaccination has the potential to prevent IMD caused by serogroups A , C , W and Y.
BACKGROUND	This phase 3b , multinational , open-label , randomized , parallel-group , multicenter study evaluated the safety of a 4-dose series of MenACWY-CRM , a quadrivalent meningococcal conjugate vaccine , concomitantly administered with routine vaccinations to healthy infants .
METHODS	Two-month-old infants were randomized 3:1 to receive MenACWY-CRM with routine vaccines or routine vaccines alone at ages 2 , 4 , 6 and 12 months .
METHODS	Adverse events ( AEs ) that were medically attended and serious adverse events ( SAEs ) were collected from all subjects from enrollment through 18 months of age .
METHODS	In a subset , detailed safety data ( local and systemic solicited reactions and all AEs ) were collected for 7 days post vaccination .
METHODS	The primary objective was a non-inferiority comparison of the percentages of subjects with 1 severe systemic reaction during Days 1-7 after any vaccination of MenACWY-CRM plus routine vaccinations versus routine vaccinations alone ( criterion : upper limit of 95 % confidence interval [ CI ] of group difference < 6 % ) .
RESULTS	A total of 7744 subjects were randomized with 1898 in the detailed safety arm .
RESULTS	The percentage of subjects with severe systemic reactions was 16 % after MenACWY-CRM plus routine vaccines and 13 % after routine vaccines alone ( group difference 3.0 % ( 95 % CI -0.8 , 6.4 % ) .
RESULTS	Although the non-inferiority criterion was not met , post hoc analysis controlling for significant center and group-by-center differences revealed that MenACWY-CRM plus routine vaccinations was non-inferior to routine vaccinations alone ( group difference -0.1 % [ 95 % CI -4.9 % , 4.7 % ] ) .
RESULTS	Rates of solicited AEs , medically attended AEs , and SAEs were similar across groups .
CONCLUSIONS	In a large multinational safety study , a 4-dose series of MenACWY-CRM concomitantly administered with routine vaccines was clinically acceptable with a similar safety profile to routine vaccines given alone .

###25322952
BACKGROUND	Endoscopic papillary balloon dilation ( EPBD ) was associated with a higher rate of endoscopic retrograde cholangiopancreatography ( ERCP ) pancreatitis ( PEP ) .
OBJECTIVE	The purpose of this study was to determine whether placement of an endoscopic nasobiliary drainage ( ENBD ) catheter can also prevent PEP after EPBD .
METHODS	A total of 93 patients , who with proven common bile duct ( CBD ) stones , received EPBD were enrolled this trial .
METHODS	They were randomly divided into ENBD group ( n = 45 ) and no-ENBD group ( n = 48 ) according whether undergone an ENBD procedure after EPBD .
METHODS	Their demographics , laboratory , procedural data were collected , and pancreaticobiliary complications were followed .
RESULTS	The number of patients with serum amylase levels above the normal upper limit ( > 180 U/L ) did not differ between groups .
RESULTS	However , compared with ENBD group , more patients in No-ENBD group had levels greater than three times the normal limit ( > 540 U/L ) ( 11/48 vs 3/45 , P = 0.0285 ) , and more patients developed to PEP ( 7/48 vs 0/45 , P = 0.0250 ) .
RESULTS	During follow-up , the numbers of patients undergone cholecystectomy , cholangitis and recurrence of CBD stones were similar .
RESULTS	There was also no significant difference in the cumulative rate of recurrent pancreaticobiliary complications between the two groups ( P = 0.452 ) .
CONCLUSIONS	EPBD followed by insertion of an ENBD catheter can prevent PEP , and routine ENBD catheter placement is recommended after an EPBD procedure .

###25701560
BACKGROUND	Use of pneumococcal conjugate vaccines ( PCVs ) in resource-poor countries has focused on early infant immunisation with little emphasis on protection in late infancy and beyond .
BACKGROUND	Boosting of the immune response later in infancy might provide improved persistence of immunogenicity into early childhood , however data are scarce .
BACKGROUND	The aim of this study was to investigate if a two-dose prime with booster at age 9 months compared with a three-dose prime-only PCV schedule provided non-inferior immunogenicity in early infancy and superior persistence of antibody responses in early childhood .
METHODS	We did an open-label , randomised , parallel group , controlled trial in healthy infants aged 40-60 days from Kathmandu , Nepal .
METHODS	Participants were randomly allocated ( 4:4:5 ratio ) to receive PCV10 in addition to routine immunisations either as a two-dose prime and boost ( 2 +1 ) , three-dose prime ( 3 +0 ) , or two doses after completion of the initial study phase ( 0 +2 ) .
METHODS	We used a computer generated randomisation list with randomly varying block sizes .
METHODS	We followed up participants at age 2-4 years together with a group of unvaccinated controls .
METHODS	Sera were analysed for opsonophagocytic activity , protein D , and PCV10 serotype-specific IgG .
METHODS	Laboratory staff was masked to intervention group assignment .
METHODS	The primary outcome measure was to determine the proportion of participants in the 2 +1 group at age 10 months with specific IgG for serotypes 1 , 5 , and 14 of at least 02 g/mL in the per-protocol population .
METHODS	The secondary outcomes were non-inferiority ( within 10 % levels ) at age 18 weeks for the proportion of participants in the 2 +1 group compared with the 3 +0 group with serotypes 1 , 5 , and 14 specific IgG of at least 02 g/mL ; the proportion of participants with PCV10 serotype-specific IgG of at least 02 g/mL and opsonophagocytic activity reciprocal titre of at least 8 at ages 18 weeks and 10 months ; and nasopharyngeal pneumococcal serotype-specific carriage rates at age 9 months in each study group .
METHODS	In the follow-up study , the primary outcome measure was the proportion of participants with IgG of at least 02 g/mL for PCV10 serotypes at age 2-4 years in children previously immunised with a 3 +0 schedule compared with a 2 +1 schedule .
METHODS	The trial is registered with Current Controlled Trials , registration number ISRCTN56766232 .
RESULTS	Between May 10 , 2010 , and Jan 7 , 2011 , 390 children were randomly assigned to each group : 119 to the 2 +1 group , 120 to the 3 +0 group , and 151 to the 0 +2 group .
RESULTS	At age 10 months , the proportions of 2 +1 participants with IgG of at least 02 g/mL were 990 % ( 95 % CI 942-1000 ) for serotype 1 , 100 % ( 962-1000 ) for serotype 5 , and 979 % ( 925-997 ) for serotype 14 .
RESULTS	At age 18 weeks , non-inferiority ( within 10 % levels ) of the 2 +1 group was shown compared with the 3 +0 group , and there was no difference between the 2 +1 and 3 +0 groups for the proportion with IgG of at least 02 g/mL for any of the PCV10 serotypes .
RESULTS	At age 10 months , proportions with IgG of at least 02 g/mL for serotypes 1 , 5 , 6B , and 23F , were higher in the 2 +1 group than in the 3 +0 group .
RESULTS	At age 18 weeks , there were no differences in opsonophagocytic activity between the 2 +1 and 3 +0 groups for reciprocal titres of at least 8 , but at age 10 months , proportions with an opsonophagocytic reciprocal titre of at least 8 for serotypes 1 , 4 , 5 , 6B , 18C , 19F and 23F were higher in the 2 +1 group than in the 3 +0 group .
RESULTS	At age 2-4 years , there were higher proportions in the 2 +1 group versus the 3 +0 group with IgG of at least 02 g/mL for serotypes 1 , 5 , 6B , and 18C .
CONCLUSIONS	Use of a 2 +1 PCV schedule with booster at age 9 months in a resource-poor setting improved antibody persistence through early childhood without compromising antibody responses in early infancy .
CONCLUSIONS	This schedule is now recommended by WHO for progressive introduction across Nepal , with PCV10 introduction having commenced on Jan 18 , 2015 .
CONCLUSIONS	Concurrent pre-implementation and post-implementation surveillance is being done by a GAVI Alliance funded study .
BACKGROUND	This study was supported by funding from the National Institute for Public Health and the Environment , The Netherlands ; Oxford Vaccine Group , University of Oxford , UK ; and GlaxoSmithKline Biologicals , Belgium .

###24682378
OBJECTIVE	To determine the safety and efficacy of intraoperative cell salvage system in decreasing the need for allogeneic transfusions in a cohort of scoliosis patients undergoing primary posterior spinal fusion with segmental spinal instrumentation .
METHODS	A total of 110 consecutive scoliosis patients undergoing posterior instrumented spinal fusion were randomized into two groups according to whether a cell saver machine for intraoperative blood salvage was used or not .
METHODS	Data included age , body mass index , perioperative hemoglobin levels , surgical time , levels fused , perioperative estimated blood loss , perioperative transfusions and incidence of transfusion-related complications .
METHODS	A Chi-square test and t tests were performed for intraoperative and perioperative allogeneic transfusion between groups .
METHODS	A regression analysis was performed between selected covariates to investigate the predictive factors of perioperative transfusion .
RESULTS	Perioperative allogenic blood transfusion rate was lower in the cell saver group ( 14.5 versus 32.7 % , p = 0.025 ) .
RESULTS	Mean intraoperative red blood cell transfusion requirement was also lower ( 0.21 U/pt versus 0.58 U/pt , p = 0.032 ) .
RESULTS	A multivariate analysis demonstrated that no .
RESULTS	of fused segments ( OR : 1.472 ; p = 0.005 ) , preoperative hemoglobin level ( OR : 0.901 ; p = 0.001 ) , and the use of cell saver system ( OR : 0.133 ; p = 0.003 ) had a trend toward significance in predicting likelihood of transfusion .
CONCLUSIONS	Cell saver use significantly reduces the need for allogeneic blood in spine deformity surgery , particularly in patients with low preoperative hemoglobin or longer operation time .
CONCLUSIONS	This study confirms the utility of routine cell saver use during PSF with segmental spinal instrumentation for scoliosis patients .

###25393894
OBJECTIVE	To compare the incidence and intensity of posterior capsular opacification ( PCO ) and neodymium : yttrium-aluminium-garnet ( Nd : YAG ) capsulotomy rates between two microincision intra-ocular lenses ( IOLs ) 3 years after surgery .
METHODS	Sixty-five patients randomly received a Y-60H IOL ( HOYA Surgical Optics , Singapore ) in one eye and a Micro AY IOL ( PhysIOL , Lige , Belgium ) in the contralateral eye during same-day bilateral cataract surgery .
METHODS	Eyes were examined 1 week , 20 months and 3 years after surgery .
METHODS	The amount of PCO ( score : 0-10 ) was assessed subjectively at the slit lamp and objectively using automated image analysis software ( aqua ) .
METHODS	Additionally , the Nd : YAG capsulotomy rate was noted .
RESULTS	Three years postoperatively , the objective PCO score of Y-60H IOLs was 1.9 1.7 compared to PCO score of 1.7 2.2 for the Micro AY IOLs ( p = 0.66 ) .
RESULTS	Thirty-four percentage of the Y-60H eyes had undergone Nd : YAG capsulotomy , compared to 49 % of the Micro AY eyes ( p = 0.04 ) .
RESULTS	Significantly , more capsular folds were observed in the Y-60H IOL group ( p = 0.001 ) .
RESULTS	There was no significant difference in best-corrected visual acuity , rhexis/IOL overlap and anterior capsule opacification 3 years after surgery .
CONCLUSIONS	Both microincision IOLs showed high YAG rates and comparable PCO scores 3 years after surgery .
CONCLUSIONS	In the light of this unsatisfying PCO performance , the advantage of the present microincision IOLs over conventional IOLs must be questioned .

###25572800
BACKGROUND	Medications are an effective intervention for managing and preventing health problems but their benefit can be undermined by non-adherence or adverse drug events ( ADEs ) .
BACKGROUND	Since these issues may be interconnected , efforts to improve non-adherence should also include reduction of ADEs .
BACKGROUND	We have developed the ISTOP-ADE system ( Information Systems-enabled Outreach for Preventing Adverse Drug Events ) , which enables timely monitoring and managing of ADEs .
BACKGROUND	The objectives of this study are to determine whether the ISTOP-ADE system , compared to routine care , will reduce : a ) the probability of discontinuing the use of prognosis-altering medications ; b ) the probability of a patient experiencing a severe ADE ; c ) the proportion of patients experiencing ADEs , preventable ADEs and ameliorable ADEs ; and d ) health services utilization .
METHODS	We will randomly assign 2,200 adult ambulatory patients in the province of Qubec who have been prescribed an incident medication for the management or prevention of a chronic health condition , to routine care or the ISTOP-ADE system .
METHODS	The ISTOP-ADE system consists of an interactive voice response system ( IVRS ) paired with pharmacist support .
METHODS	The IVRS will call patients at 3 and 17days post-prescription to determine if they are experiencing any problems and connect them with a pharmacist when required or desired by the patient .
METHODS	We will evaluate medication persistence at 180days and health-care utilization using provincial administrative data .
METHODS	Two blinded physicians will ascertain ADE status through a case review .
CONCLUSIONS	We expect the ISTOP-ADE intervention to be feasible and to improve the quality of patient care through improved medication adherence , reduced ADE duration and reduced number of ADEs resulting in an emergency department or inpatient encounter .
CONCLUSIONS	This in turn could lower health-care utilization , saving costs and lowering the burden on emergency departments and family practices .
CONCLUSIONS	The success of ISTOP-ADE would present opportunities to implement this intervention through health systems , health insurance agents and commercial pharmacies .
BACKGROUND	ClinicalTrials.gov Identifier : NCT02059044 .
BACKGROUND	Date registered : 10 January 2014 .

###24237718
BACKGROUND	Entering primary school is an important childhood milestone , marking the beginning of a child 's formal education .
BACKGROUND	Yet the change creates a time of vulnerability for the child , the parents and the parent-child relationship .
BACKGROUND	Failure to adjust to the transition may place the family in a psychologically devastating position .
BACKGROUND	The aims of this study were to test the effectiveness of a parental training programme in enhancing the parent-child relationship and decreasing parental stress by reducing harsh parenting in preparing children for the transition to primary school .
METHODS	A randomised controlled trial incorporating a two-group pre-test and repeated post-test was conducted in one of the largest public housing estates in Hong Kong .
METHODS	A total of 142 parents were recruited , with 72 parents randomly assigned to the experimental group and 70 to the control group .
METHODS	Harsh parenting practices , parent-child relationships and parental stress were assessed .
RESULTS	In comparison to parents in the control group , those in the experimental group engaged in less harsh parenting practices and reported better parent-child relationships .
RESULTS	However , parental stress scores did not differ significantly between the two groups .
CONCLUSIONS	This study addressed a gap in the literature by examining the effectiveness of the training programme for enhancing parent-child relationship and decreasing parental stress at the time of a child 's transition to primary school .
CONCLUSIONS	The findings from this study provide empirical evidence of the effectiveness of the parental training programme and highlight the significance of parenting in promoting a smooth transition for children from kindergarten to primary 1 .
BACKGROUND	ClinicalTrials.gov : NCT01845948 .

###24422605
BACKGROUND	Postpartum depression ( PPD ) and poor childbirth outcomes are associated with poverty ; these variables should be addressed by an adapted approach .
BACKGROUND	The aim of this research was to evaluate the impact of an antenatal programme based on a novel psychosomatic approach to pregnancy and delivery , regarding the risk of PPD and childbirth outcomes in disadvantaged women .
METHODS	A multi-centre , randomized , controlled trial comparing a novel to standard antenatal programme .
METHODS	Primary outcome was depressive symptoms ( using EPDS ) and secondary outcome was preterm childbirth ( fewer 37 weeks ) .
METHODS	The sample comprised 184 couples in which the women were identified to be at PPD risk by validated interview .
METHODS	The study was conducted in three public hospitals with comparable standards of perinatal care .
METHODS	Women were randomly distributed in to an experimental group ( EG ) or a control group ( CG ) , and evaluated twice : during pregnancy ( T1 ) and four weeks post-partum ( T2 ) .
METHODS	At T2 , the variables were compared using the chi square test .
METHODS	Data analysis was based on intention to treat .
METHODS	The novel programme used the Tourn psychosomatic approach focusing on body awareness sensations , construction of an individualized childbirth model , and attachment .
METHODS	The 10 group antenatal sessions each lasted two hours , with one telephone conversation between sessions .
METHODS	In the control group , the participants choose the standard model of antenatal education , i.e. , 8 to 10 two-hour sessions focused on childbirth by obstetrical prophylaxis .
RESULTS	A difference of 11.2 % was noted in postpartum percentages of PPD risk ( EPDS 12 ) : 34.3 % ( 24 ) in EG and 45.5 % ( 27 ) in CG ( p = 0.26 ) .
RESULTS	The number of depressive symptoms among EG women decreased at T2 ( intragroup p = 0.01 ) .
RESULTS	Premature childbirth was four times less in EG women : three ( 4.4 % ) compared to 13 ( 22.4 % ) among CG women ( p = 0.003 ) .
RESULTS	Birth weight was higher in EG women ( p = 0.01 ) .
CONCLUSIONS	The decrease of depressive symptoms in women was not conclusive .
CONCLUSIONS	However , because birth weight was higher and the rate of preterm childbirth was lower in the EG , our results suggest that the psychosomatic approach may be more helpful to the target population than the standard antenatal programs .

###25319120
OBJECTIVE	To evaluate the effects of canrenone compared to placebo on blood pressure control , some non-conventional biomarkers in cardiovascular stratification , and on metalloproteinases in patients affected by metabolic syndrome .
METHODS	A total of 156 Caucasian patients were treated with placebo or canrenone , 50 mg once a day , for 3 months and then 50 mg twice a day , till the end of the study .
METHODS	We evaluated : systolic ( SBP ) and diastolic blood pressure ( DBP ) , body weight , body mass index ( BMI ) , fasting plasma glucose ( FPG ) , lipid profile , plasma aldosterone , creatinine , potassium , brain natriuretic peptide ( BNP ) , metalloproteinases 2 and 9 ( MMP-2 and -9 ) , lipoprotein ( a ) ( Lp ( a ) ) , and serum myeloperoxidase ( MPO ) .
RESULTS	We observed a significant decrease of SBP and DBP in the canrenone group compared to baseline .
RESULTS	Canrenone gave a significant decrease of MMP-2 and -9 , Lp ( a ) , and MPO compared to baseline , not observed with placebo .
RESULTS	Plasma aldosterone , but not BNP , decreased with canrenone , both compared to baseline and to placebo .
CONCLUSIONS	Canrenone seems to be effective in reducing blood pressure in patients with metabolic syndrome .
CONCLUSIONS	Moreover , canrenone seems also to improve MPO , Lp ( a ) , and metalloproteinases in these patients .

###24964869
BACKGROUND	Health promotion at the work site in terms of physical activity has proven positive effects but optimization of relevant exercise training protocols and implementation for high adherence are still scanty .
METHODS	The aim of this paper is to present a study protocol with a conceptual model for planning the optimal individually tailored physical exercise training for each worker based on individual health check , existing guidelines and state of the art sports science training recommendations in the broad categories of cardiorespiratory fitness , muscle strength in specific body parts , and functional training including balance training .
METHODS	The hypotheses of this research are that individually tailored worksite-based intelligent physical exercise training , IPET , among workers with inactive job categories will : 1 ) Improve cardiorespiratory fitness and/or individual health risk indicators , 2 ) Improve muscle strength and decrease musculoskeletal disorders , 3 ) Succeed in regular adherence to worksite and leisure physical activity training , and 3 ) Reduce sickness absence and productivity losses ( presenteeism ) in office workers .
METHODS	The present RCT study enrolled almost 400 employees with sedentary jobs in the private as well as public sectors .
METHODS	The training interventions last 2 years with measures at baseline as well as one and two years follow-up .
CONCLUSIONS	If proven effective , the intelligent physical exercise training scheduled as well as the information for its practical implementation can provide meaningful scientifically based information for public health policy .
BACKGROUND	ClinicalTrials.gov , number : NCT01366950 .

###25065668
OBJECTIVE	This phase I study assessed the pharmacokinetic ( PK ) , tolerability , safety and preliminary clinical activity of tamoxifen ( T ) and lapatinib ( L ) in patients with metastatic breast cancer ( MBC ) .
METHODS	Patients ( pts ) with hormone receptor positive MBC , irrespective of HER-2 status , were randomly assigned to T T + L group , tamoxifen in cycle 1 for 28 days then adding lapatinib on day 1 of cycle 2 ; or L T + L group , lapatinib in cycle 1 for 14 days , then adding tamoxifen on day 1 of cycle 2 to evaluate the potential drug-drug PK interaction at steady-state .
METHODS	The dose of tamoxifen was 20 mg/day and lapatinib 1500 mg/day .
RESULTS	Twenty-five pts were enrolled of which 23 started treatment , five ( 22 % ) of them were HER-2 positive .
RESULTS	Median age was 59 years and 96 % had PS 1 .
RESULTS	Eleven ( 91.7 % ) pts in the T T + L group and 10 ( 76.9 % ) in L T + L group received at least 2 cycles of treatment .
RESULTS	The most frequently reported drug-related adverse events ( > 25 % of patients ) were diarrhoea ( 62 % ) , anaemia ( 56 % ) , rash ( 52 % ) , fatigue ( 52 % ) , dermatology other ( 34 % ) and leukopenia ( 28 % ) .
RESULTS	Grade 3-4 drug-related toxicities were infrequent ( < 10 % ) .
RESULTS	No cardiotoxicity was observed .
RESULTS	T plasma concentrations did not appeared to be affected by the presence of lapatinib .
RESULTS	L steady-state plasma concentrations were 20 % lower after 28 days of co-administration with T. Eight ( 36.4 % ) patients experienced stable disease and median progression free survival was 2.7 months .
CONCLUSIONS	The combination of L and T was safe and clinically active .
CONCLUSIONS	T affected L plasma concentrations , which remained within the therapeutic index .

###24405258
METHODS	Repeated-measures , crossover , double-blinded randomized controlled trial .
OBJECTIVE	To compare the immediate effectiveness of 2 types of counterforce braces in improving pain-free grip strength , pressure pain threshold , and wrist angle during a gripping task in individuals with lateral epicondylalgia .
BACKGROUND	Sports medicine management of lateral epicondylalgia often includes application of a counterforce brace , but the comparative effectiveness of different braces is unclear .
BACKGROUND	The most common brace design consists of a single strap wrapped around the proximal forearm .
BACKGROUND	A variation of this brace is the use of an additional strap that wraps above the elbow , which aims to provide further unloading to the injured tissue .
METHODS	Pain-free grip strength , pressure pain threshold , and wrist angle during a gripping task were measured on 34 participants with a clinical diagnosis of lateral epicondylalgia ( mean SD age , 47.8 8.5 years ) .
METHODS	Measurements were made without a brace , as well as immediately before and after the application of 2 types of counterforce braces .
METHODS	Each condition was tested during a separate session , with a minimum of 48 hours between sessions .
METHODS	Analysis-of-variance models were used to test the differences within and between conditions .
RESULTS	Pain-free grip strength ( 17.2 N ; 95 % confidence interval : 7.5 , 26.8 ) and pressure pain threshold ( 42.2 kPa ; 95 % confidence interval : 16.5 , 68.0 ) significantly improved on the affected side immediately following the intervention conditions as well as the control condition .
RESULTS	There was no significant difference between braces or the control condition for any outcome .
CONCLUSIONS	Both types of counterforce braces had an immediate positive effect in participants with lateral epicondylalgia , without differences between interventions and similar to a no-brace control condition .
CONCLUSIONS	Therefore , while the use of a brace may be helpful in managing immediate symptoms related to lateral epicondylalgia , the choice of which brace to use may be more a function of patient preference , comfort , and cost .
CONCLUSIONS	Further research is required to investigate the comparative longer-term and clinical effects of the 2 braces .
BACKGROUND	ACTRN12609000354280 ( www.anzctr.org.au ) .

###24348029
BACKGROUND	The issue of osteoporosis-induced fractures has attracted the world 's attention .
BACKGROUND	Postmenopausal women are particularly at risk for this type of fracture .
BACKGROUND	The nonmedicinal intervention for postmenopausal women is mainly exercise .
BACKGROUND	Whole body vibration ( WBV ) is a simple and convenient exercise .
BACKGROUND	There have been some studies investigating the effect of WBV on osteoporosis ; however , the intervention models and results are different .
BACKGROUND	This study mainly investigated the effect of high-frequency and high-magnitude WBV on the bone mineral density ( BMD ) of the lumbar spine in postmenopausal women .
METHODS	This study randomized 28 postmenopausal women into either the WBV group or the control group for a 6-month trial .
METHODS	The WBV group received an intervention of high-frequency ( 30 Hz ) and high-magnitude ( 3.2 g ) WBV in a natural full-standing posture for 5 minutes , three times per week , at a sports center .
METHODS	Dual-energy X-ray absorptiometry was used to measure the lumbar BMD of the two groups before and after the intervention .
RESULTS	Six months later , the BMD of the WBV group had significantly increased by 2.032 % ( P = 0.047 ) , while that of the control group had decreased by 0.046 % ( P = 0.188 ) .
RESULTS	The comparison between the two groups showed that the BMD of the WBV group had increased significantly ( P = 0.016 ) .
CONCLUSIONS	This study found that 6 months of high-frequency and high-magnitude WBV yielded significant benefits to the BMD of the lumbar spine in postmenopausal women , and could therefore be provided as an alternative exercise .

###24796049
OBJECTIVE	To explore correlation between lung and large intestine and the two meridians under pathological condition in the view of meridian theory .
METHODS	Ninety-six cases of bronchial asthma were applied palpation at the running course of 12 regular meridians under the elbow and knees and back-shu points .
METHODS	And abnormal reactions were recorded , the affected meridians and back-shu points were discovered .
RESULTS	The abnormal reactions most frequently appeared on the Lung Meridian , followed by the Large Intestine Meridian , the Spleen Meridian , the Liver Meridian , the Stomach Meridian and the Triple Energizer Meridian .
RESULTS	And the unusual reaction of the back-shu points most frequently appeared on Feishu ( BL 13 ) , and Dachangshu ( BL 25 ) and Pishu ( BL 21 ) followed as the next two .
CONCLUSIONS	The existence of correlation between the Lung Meridian and the Large Intestine Meridians under pathological condition can be proved through meridian and acupoint palpation on bronchial asthma patients .

###24960268
BACKGROUND	Catheter ablation of atrial fibrillation ( AF ) is a physically demanding procedure for the operator , involving radiation exposure , and has limited success rates .
BACKGROUND	Remote robotic navigation ( RRN ) may offer benefit to the procedure , though only 1 previous small randomized trial has assessed this .
OBJECTIVE	This study aimed to investigate the impact of RRN on 1-year single-procedure success rates .
METHODS	RRN was compared to manual ablation in a randomized control trial setting by using an intention-to-treat analysis .
RESULTS	A total of 157 patients underwent ablation ( 116/157 ( 74 % ) persistent AF ; 67/116 ( 58 % ) of these long-standing persistent AF ) .
RESULTS	There were no significant differences between the RRN and manual groups with respect to 1-year single-procedure success rates ( 19/78 ( 24 % ) and 26/78 ( 33 % ) , respectively ; P = .29 ) , acute wide area circumferential ablation reconnection rates , complication rates , or procedure times .
RESULTS	On multivariable analysis , fluoroscopy times were significantly shorter in the RRN group .
RESULTS	The number of catheter displacements during ablation was lower in the RRN group , as was subjectively assessed operator fatigue .
RESULTS	The crossover rate from RRN to manual ablation was 11/78 ( 14 % ) , mainly secondary to technical problems with the RRN system .
RESULTS	A learning curve was evident for RRN ablation : the fluoroscopy and procedure times were significantly lower after the first 10 cases in an operator 's experience .
CONCLUSIONS	This randomized trial showed no difference in the success rate for catheter ablation of AF between a RRN and manual approach .
CONCLUSIONS	The results highlight the learning curve for RRN ablation and suggest that the use of this technology leads to an improvement in fluoroscopy times , catheter stability , and operator fatigue .

###25171270
OBJECTIVE	We aimed to examine the association between daily protein intake ( DPI ) and outcomes in patients from the Randomized Evaluation of Normal versus Augmented Level ( RENAL ) trial .
METHODS	We analyzed the association between DPI and clinical outcomes using multivariable logistic regression , Cox proportional hazards models and time-adjusted analysis .
RESULTS	During ICU stay , mean DPI was 37.6 g/day among survivors and 37.7 g/day among nonsurvivors ( p = 0.96 ; DPI of 0.5 g/kg/day ) .
RESULTS	Only 159 ( 10.9 % ) of the patients received a mean DPI of > 1 g/kg .
RESULTS	Patients with a DPI above the median had a 43.1 % mortality compared with 46.1 % for a DPI below the median ( p = 0.25 ) .
RESULTS	On multivariate analysis , a lower DPI was not associated with increased odds ratios for 90-day mortality or any secondary outcomes .
RESULTS	Cox proportional hazards models and time-adjusted analysis confirmed these findings .
CONCLUSIONS	In the RENAL study , mean DPI was low .
CONCLUSIONS	Within the confines of such low DPI , greater amounts of DPI were not independently associated with improved clinical outcomes .
CONCLUSIONS	Video Journal Club `` Cappuccino with Claudio Ronco '' at www.karger.com/?doi=363175 .

###24268211
BACKGROUND	The implantable cardioverter defibrillator ( ICD ) is better than antiarrhythmic drug therapy for the primary and secondary prevention of all-cause mortality and sudden cardiac death in patients with either coronary artery disease or idiopathic dilated cardiomyopathy .
BACKGROUND	This study aims to assess whether the ICD also has this effect for primary prevention in chronic Chagas cardiomyopathy ( CCC ) .
METHODS	In this randomized ( concealed allocation ) open-label trial , we aim to enroll up to 1,100 patients with CCC , a Rassi risk score for death prediction of 10 points , and at least 1 episode of nonsustained ventricular tachycardia on a 24-hour Holter monitoring .
METHODS	Patients from 28 centers in Brazil will be randomly assigned in a 1:1 ratio to receive an ICD or amiodarone ( 600 mg/d for 10 days , then 200-400 mg/d until the end of the study ) .
METHODS	The randomization sequence will be generated by computer , and the members of the committees responsible for end point validation and data analysis will be blinded to study assignment .
METHODS	The primary end point is all-cause death , and enrolment will continue until 256 patients have reached this end point .
METHODS	Key secondary end points include cardiovascular death , sudden cardiac death , hospitalization for heart failure , and quality of life .
METHODS	We expect follow-up to last 3 to 6 years , and data analysis will be done on an intention-to-treat basis .
METHODS	This trial is registered with ClinicalTrials.gov number NCT01722942 .
CONCLUSIONS	CHAGASICS is the first large-scale trial to assess the benefit of ICD therapy for the primary prevention of death in patients with CCC and nonsustained ventricular tachycardia , who have a moderate to high risk of death .

###25348573
BACKGROUND	The efficacy , acceptability and tolerability of the new oral phosphate binder Lenziaren ( SBR759 ) were evaluated in a randomized parallel-group design study in 36 healthy cats ( n = 6 per group ) .
BACKGROUND	Five groups were fed once daily with a commercial diet containing 0.2 % phosphorus ( `` standard diet '' ) into which was mixed Lenziaren at 0.25 , 0.5 , 1.0 or 2.0 g/day or no treatment ( control group ) daily for 30 days .
BACKGROUND	A sixth group was fed a commercial diet containing lower amounts ( 0.12 % ) of phosphorus ( `` renal diet '' ) and no treatment .
RESULTS	When compared to the control group , Lenziaren produced significant dose-related reductions in urine phosphate concentrations , urine phosphate excretion and fractional urinary phosphate excretion .
RESULTS	Significant effects versus the control group were observed at the 0.5 , 1.0 and 2.0 g/day dosages .
RESULTS	Lenziaren was well tolerated and was associated with higher food consumption and serum iron concentrations versus the control .
RESULTS	When compared to the control group , the renal diet was associated with significantly lower urine phosphate concentrations and loss of body weight .
RESULTS	Lenziaren had similar effects on urine phosphate concentrations compared to the renal diet , but was not associated with loss of body weight .
CONCLUSIONS	Lenziaren was effective as an oral phosphate binder in cats fed with a standard diet containing 0.2 % phosphorus .
CONCLUSIONS	The acceptability and tolerability were good .
CONCLUSIONS	Dosages of 0.5-1 .0 g/cat per day are recommended for clinical testing in cats fed with a standard diet .

###25311284
OBJECTIVE	The present study evaluated three technology-based methods of training mental health providers in exposure therapy ( ET ) for anxiety disorders .
OBJECTIVE	Training methods were designed to address common barriers to the dissemination of ET , including limited access to training , negative clinician attitudes toward ET , and lack of support during and following training .
METHODS	Clinicians nave to ET ( N = 181 , Mage = 37.4 , 71.3 % female , 72.1 % Caucasian ) were randomly assigned to ( a ) an interactive , multimedia online training ( OLT ) , ( b ) OLT plus a brief , computerized motivational enhancement intervention ( OLT+ME ) , or ( c ) OLT+ME plus a Web-based learning community ( OLT+ME+LC ) .
METHODS	Assessments were completed at baseline , posttraining , and 6 and 12weeks following training .
METHODS	Outcomes include satisfaction , knowledge , self-efficacy , attitudes , self-reported clinical use , and observer-rated clinical proficiency .
RESULTS	All three training methods led to large and comparable improvements in self-efficacy and clinical use of ET , indicating that OLT alone was sufficient for improving these outcomes .
RESULTS	The addition of the ME intervention did not significantly improve outcomes in comparison to OLT alone .
RESULTS	Supplementing the OLT with both the ME intervention and the LC significantly improved attitudes and clinical proficiency in comparison to OLT alone .
RESULTS	The OLT+ME+LC condition was superior to both other conditions in increasing knowledge of ET .
CONCLUSIONS	Multicomponent trainings that address multiple potential barriers to dissemination appear to be most effective in improving clinician outcomes .
CONCLUSIONS	Technology-based training methods offer a satisfactory , effective , and scalable way to train mental health providers in evidence-based treatments such as ET .

###24771805
BACKGROUND	We compared intestinal , hepatic , and other organ function after hepatic portal occlusion with or without dexmedetomidine administration under general anaesthesia .
METHODS	In this prospective , randomized double-blind investigation , 44 patients undergoing elective hepatectomy with inflow occlusion were randomized into a dexmedetomidine group or a control group .
METHODS	The dexmedetomidine group received an initial dexmedetomidine loading dose of 1 g kg ( -1 ) over 10 min followed by a maintenance dose of 0.3 g kg ( -1 ) h ( -1 ) .
METHODS	In the control group , 0.9 % sodium chloride was administered .
METHODS	The primary outcome was serum diamine oxidase ( DAO ) activity reflecting intestinal injury .
METHODS	The secondary outcomes included variables reflecting intestinal , hepatic , kidney , and cardiopulmonary function , and biomarkers of oxidative stress and systemic inflammatory response .
RESULTS	DAO activity was lower in the dexmedetomidine group than in the control group at 6 and 24 h after liver reperfusion [ 9.77 ( 1.07 ) vs14 .29 ( 1.43 ) units ml ( -1 ) , P = 0.021 ; 9.67 ( 0.98 ) vs 13.97 ( 1.31 ) units ml ( -1 ) , P = 0.017 ] .
RESULTS	d-lactate acid levels were lower during 1-72 h after liver reperfusion compared with the control group ( all P < 0.05 ) .
RESULTS	Also , the intestinal injury severity grade was decreased by dexmedetomidine ( P = 0.038 ) .
RESULTS	The biomarkers reflecting liver injury increased over time , but were lower in the dexmedetomidine group ( all P < 0.05 ) , while the variables reflecting cardiopulmonary and renal function showed no differences between the groups ( all P > 0.05 ) .
CONCLUSIONS	Dexmedetomidine administered perioperatively attenuates intestinal and hepatic injury in patients undergoing elective liver resection with inflow occlusion without any potential risk .
BACKGROUND	ChiCTR-TRC-11001530 , September 2011 .

###24300220
OBJECTIVE	Nonsteroidal anti-inflammatory drugs are efficacious for the treatment of acute and chronic pain ; however , they have the potential for serious adverse events ( AEs ) .
OBJECTIVE	The objective of this study was to evaluate the efficacy and safety of investigational , lower-dose , indomethacin submicron particle capsules compared with placebo in a study of patients with postsurgical pain .
METHODS	This phase 2 , multicenter , randomized , double-blind , single-dose , and placebo-controlled study enrolled 203 patients ( 18 to 50 y old ) following extraction of 2 third molars who experienced moderate-to-severe pain intensity 6 hours after surgery .
METHODS	Patients received indomethacin submicron particle capsules ( 20 or 40 mg ) , celecoxib 400 mg , or placebo .
METHODS	The primary efficacy endpoint was the sum of total pain relief over 0 to 8 hours ( TOTPAR-8 ) determined from the area under the curve for pain relief over 0 to 8 hours following administration of the study drug , where pain relief was measured on a 0 to 4 scale .
METHODS	Safety and tolerability were also assessed .
RESULTS	Mean SE TOTPAR-8 scores were 10.8 1.4 ( indomethacin submicron particle capsules 20 mg ) , 12.6 1.3 ( indomethacin submicron particle capsules 40 mg ) , 14.8 1.3 ( celecoxib ) , and 3.0 1.3 ( placebo ; P < 0.001 for active treatments vs. placebo ) .
RESULTS	Indomethacin submicron particle capsules treatment groups demonstrated better mean TOTPAR over 4 hours than placebo ( P < 0.001 ) .
RESULTS	Similar rates and profiles of treatment-emergent AEs were reported by patients across treatment groups .
CONCLUSIONS	Lower-dose , indomethacin submicron particle capsules provide good overall pain relief in patients with postsurgical pain and are generally well tolerated .
CONCLUSIONS	Indomethacin submicron particle capsules are a potentially promising option for treatment of acute pain and warrant further study .

###24262440
BACKGROUND	National Surgical Adjuvant Breast and Bowel Project ( NSABP ) trial B-31 suggested the efficacy of adjuvant trastuzumab , even in HER2-negative breast cancer .
BACKGROUND	This finding prompted us to develop a predictive model for degree of benefit from trastuzumab using archived tumor blocks from B-31 .
METHODS	Case subjects with tumor blocks were randomly divided into discovery ( n = 588 ) and confirmation cohorts ( n = 991 ) .
METHODS	A predictive model was built from the discovery cohort through gene expression profiling of 462 genes with nCounter assay .
METHODS	A predefined cut point for the predictive model was tested in the confirmation cohort .
METHODS	Gene-by-treatment interaction was tested with Cox models , and correlations between variables were assessed with Spearman correlation .
METHODS	Principal component analysis was performed on the final set of selected genes .
METHODS	All statistical tests were two-sided .
RESULTS	Eight predictive genes associated with HER2 ( ERBB2 , c17orf37 , GRB7 ) or ER ( ESR1 , NAT1 , GATA3 , CA12 , IGF1R ) were selected for model building .
RESULTS	Three-dimensional subset treatment effect pattern plot using two principal components of these genes was used to identify a subset with no benefit from trastuzumab , characterized by intermediate-level ERBB2 and high-level ESR1 mRNA expression .
RESULTS	In the confirmation set , the predefined cut points for this model classified patients into three subsets with differential benefit from trastuzumab with hazard ratios of 1.58 ( 95 % confidence interval [ CI ] = 0.67 to 3.69 ; P = .29 ; n = 100 ) , 0.60 ( 95 % CI = 0.41 to 0.89 ; P = .01 ; n = 449 ) , and 0.28 ( 95 % CI = 0.20 to 0.41 ; P < .001 ; n = 442 ; P ( interaction ) between the model and trastuzumab < .001 ) .
CONCLUSIONS	We developed a gene expression-based predictive model for degree of benefit from trastuzumab and demonstrated that HER2-negative tumors belong to the moderate benefit group , thus providing justification for testing trastuzumab in HER2-negative patients ( NSABP B-47 ) .

###25724233
OBJECTIVE	To assess the neuropsychological outcome 12 months after bilateral deep brain stimulation ( DBS ) of the globus pallidus pars interna ( GPi ) or subthalamic nucleus ( STN ) for advanced Parkinson disease .
METHODS	We randomly assigned patients to receive either GPi DBS or STN DBS .
METHODS	Standardized neuropsychological tests were performed at baseline and after 12 months .
METHODS	Patients and study assessors were masked to treatment allocation .
RESULTS	Univariate analysis of change scores indicated group differences on Stroop word reading and Stroop color naming ( confidence interval [ CI ] 1.9-10 .0 and 2.1-8 .8 ) , on Trail Making Test B ( CI 0.5-10 .3 ) , and on Wechsler Adult Intelligence Scale similarities ( CI -0.01 to 1.5 ) , with STN DBS showing greater negative change than GPi DBS .
RESULTS	No differences were found between GPi DBS and STN DBS on the other neuropsychological tests .
RESULTS	Older age and better semantic fluency at baseline predicted cognitive decline after DBS .
CONCLUSIONS	We found no clinically significant differences in neuropsychological outcome between GPi DBS and STN DBS .
CONCLUSIONS	No satisfactory explanation is available for the predictive value of baseline semantic fluency for cognitive decline .
METHODS	This study provides Class I evidence that there is no large difference in neuropsychological outcome between GPi DBS and STN DBS after 12 months .
METHODS	The study lacks the precision to exclude a moderate difference in outcomes .

###25274787
BACKGROUND	There are relatively few studies in the literature that specifically evaluate accelerated rehabilitation protocols for distal radial fractures treated with open reduction and internal fixation ( ORIF ) .
BACKGROUND	The purpose of this study was to compare the early postoperative outcomes ( at zero to twelve weeks postoperatively ) of patients enrolled in an accelerated rehabilitation protocol with those of patients enrolled in a standard rehabilitation protocol following ORIF for a distal radial fracture .
BACKGROUND	We hypothesized that patients with accelerated rehabilitation after volar ORIF for a distal radial fracture would have an earlier return to function compared with patients who followed a standard protocol .
METHODS	From November 2007 to November 2010 , eighty-one patients with an unstable distal radial fracture were prospectively randomized to follow either an accelerated or a standard rehabilitation protocol after undergoing ORIF with a volar plate for a distal radial fracture .
METHODS	Both groups began with gentle active range of motion at three to five days postoperatively .
METHODS	At two weeks , the accelerated group initiated wrist/forearm passive range of motion and strengthening exercises , whereas the standard group initiated passive range of motion and strengthening at six weeks postoperatively .
METHODS	Patients were assessed at three to five days , two weeks , three weeks , four weeks , six weeks , eight weeks , twelve weeks , and six months postoperatively .
METHODS	Outcomes included Disabilities of the Arm , Shoulder and Hand ( DASH ) scores ( primary outcome ) and measurements of wrist flexion/extension , supination , pronation , grip strength , and palmar pinch .
RESULTS	The patients in the accelerated group had better mobility , strength , and DASH scores at the early postoperative time points ( zero to eight weeks postoperatively ) compared with the patients in the standard rehabilitation group .
RESULTS	The difference between the groups was both clinically relevant and statistically significant .
CONCLUSIONS	Patients who follow an accelerated rehabilitation protocol that emphasizes motion immediately postoperatively and initiates strengthening at two weeks after volar ORIF of a distal radial fracture have an earlier return to function than patients who follow a more standard rehabilitation protocol .
METHODS	Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence .

###24798178
OBJECTIVE	To compare the effects of administering equal volumes of isotonic crystalloids and synthetic colloids on hemodynamic and laboratory variables in healthy dogs and dogs with systemic inflammation .
METHODS	Randomized , placebo-controlled , blinded study .
METHODS	Comparative clinical research facility .
METHODS	Sixteen adult purpose-bred Beagles .
METHODS	Dogs were first randomized to receive either lipopolysaccharide ( LPS ; 5 g/kg , IV ) or an equal volume of placebo ( 0.9 % NaCl , IV ) .
METHODS	Dogs were then randomized into 1 of 2 groups receiving fluid resuscitation with either 40 mL/kg IV isotonic crystalloid ( 0.9 % NaCl ) or synthetic colloid ( tetrastarch ) .
METHODS	After a 14-day washout , the study was repeated such that dogs received the opposite treatment ( LPS or placebo ) and the same resuscitation fluid regimen .
METHODS	Vital signs ( heart rate ( HR ) , oscillometric blood pressure ) were measured and blood samples were collected for PCV , total plasma protein ( TPP ) , serum lactate concentration , and colloid osmotic pressure ( COP ) measurements .
RESULTS	Healthy ( placebo ) dogs had similar decreases in PCV and TPP after administration of either fluid .
RESULTS	Tetrastarch administration was associated with a larger increase in HR , systolic blood pressure , and mean blood pressure .
RESULTS	Dogs with systemic inflammation had similar increases in systolic blood pressure and decreases in PCV , TPP , and lactate after administration of either fluid .
RESULTS	Tetrastarch administration caused greater immediate increase in HR and mean blood pressure compared to 0.9 % NaCl .
RESULTS	In all dogs , 0.9 % NaCl administration decreased COP and tetrastarch administration increased COP .
CONCLUSIONS	Resuscitation with equal volumes of 0.9 % NaCl and tetrastarch caused similar changes in hemodynamic and laboratory variables in dogs with LPS-induced systemic inflammation ; however , larger increases in HR and blood pressure were seen within the first 2 hours following tetrastarch administration compared to 0.9 % NaCl .
CONCLUSIONS	Tetrastarch administration increased COP in all dogs , despite a decrease in TPP .

###25799714
OBJECTIVE	Aortic valve replacement ( AVR ) in patients with a small aortic root is often associated with some degree of obstruction and residual gradients .
OBJECTIVE	Stentless valves display better hemodynamic performance than stented valves , and might be ideal in patients with a small aortic annulus .
OBJECTIVE	A new stented bioprosthesis , the Trifecta valve , has recently become available and has yielded interesting early results .
OBJECTIVE	The study aim was to compare the hemodynamic performance of the Trifecta valve with that of the Freestyle valve in patients with an aortic annulus 2.3 cm .
METHODS	Between September 2011 and September 2013 , a total of 40 patients with pure aortic stenosis and native aortic annulus diameter 2.3 cm was randomized to receive either a St. Jude Medical Trifecta stented prosthesis ( n = 20 ) or a Medtronic Freestyle stentless prosthesis ( n = 20 ) .
METHODS	Hemodynamics results were compared between the two groups on discharge from hospital .
RESULTS	The Trifecta valve showed slightly better hemodynamics , with peak gradients of 11 5 mmHg and 17 9 mmHg ( p = 0.009 ) , and mean gradients of 5.5 3 mmHg and 7.5 4 mmHg ( p = 0.06 ) for the Trifecta and Freestyle valves , respectively .
RESULTS	The average indexed effective orifice area ( EOAi ) was 1.14 0.23 cm2/m2 and 1.09 0.20 cm2/m2 ( p = 0.520 ) for the Trifecta and Freestyle , respectively .
RESULTS	Patient-prosthesis mismatch ( PPM ) occurred in two patients of the Freestyle group , and in three patients of the Trifecta group .
CONCLUSIONS	In the present study , the stentless and stented prostheses each yielded comparable and excellent early hemodynamics results .
CONCLUSIONS	The data obtained suggest that Trifecta valve implantation is a valid means of avoiding PPM after AVR in patients with a small native aortic annulus .

###24350662
OBJECTIVE	To evaluate the efficacy and safety of once-daily oxybutynin patch therapy for overactive bladder .
METHODS	A randomized double-blind trial was carried out in patients with overactive bladder syndrome , who received an oxybutynin patch , propiverine ( 20 mg ) or placebo once daily for 12 weeks .
METHODS	The primary efficacy end-point was the change of the mean daily number of micturitions in week 12 .
RESULTS	A total of 1530 patients were randomized to receive the oxybutynin patch ( 573 ) , propiverine ( 576 ) or placebo ( 381 ) .
RESULTS	The change of the mean daily frequency of micturition from baseline in the full analysis set was -1.89 2.04 with the oxybutynin patch , which was significantly higher than with placebo ( -1.44 2.23 ) ( P = 0.0015 ) .
RESULTS	The difference of the mean change in the mean daily number of micturitions between the oxybutynin patch and propiverine groups showed a 95 % confidence interval of -0.28 to 0.21 , and the upper limit of this interval was below the predefined non-inferiority margin of 0.37 , showing non-inferiority of the oxybutynin patch to propiverine .
RESULTS	The incidence of dry mouth and constipation was higher with propiverine than with the oxybutynin patch or placebo .
RESULTS	Application site dermatitis was more frequent with the oxybutynin patch ( 31.8 % ) than with propiverine ( 5.9 % ) or placebo ( 5.2 % ) , but the dermatitis was generally mild .
CONCLUSIONS	This trial shows the efficacy of the new once-daily oxybutynin patch for overactive bladder .
CONCLUSIONS	Despite a higher rate of dermatitis with the oxybutynin patch , dry mouth and constipation occurs less often than during treatment with propiverine .

###24934429
OBJECTIVE	This study evaluated the effect of different types of activities during rest-break interventions on neck and shoulder muscle activity , muscle discomfort and productivity among symptomatic video display unit ( VDU ) operators performing prolonged computer terminal work .
METHODS	Randomized controlled trial was used .
METHODS	Thirty symptomatic VDU operators were randomly assigned to 2 active break groups ( stretching and dynamic movement ) and a reference group .
METHODS	The subjects performed the same typing task for 60 min and received 3-min breaks after each 20 min of work .
METHODS	Root mean square and median frequency were calculated for neck and shoulder muscle activity .
METHODS	Muscle discomfort was measured with Borg 's CR-10 scale .
METHODS	Productivity was measured by counting words .
RESULTS	There were no significant differences between the types of activities during breaks on neck and shoulder muscle activity , muscle discomfort or productivity .
RESULTS	However , there was a significant difference in the level of muscle discomfort over time .
CONCLUSIONS	Three types of activity during breaks showed a favourable effect on neck and shoulder muscle activity and productivity , and a positive effect on muscle discomfort in symptomatic VDU operators .

###24486635
BACKGROUND	Physician-delivered tobacco treatment using the 5As is clinically recommended , yet its use has been limited .
BACKGROUND	Lack of adequate training and confidence to provide tobacco treatment is cited as leading reasons for limited 5A use .
BACKGROUND	Tobacco dependence treatment training while in medical school is recommended , but is minimally provided .
BACKGROUND	The MSQuit trial ( Medical Students helping patients Quit tobacco ) aims to determine if a multi-modal and theoretically-guided tobacco educational intervention will improve tobacco dependence treatment skills ( i.e. 5As ) among medical students .
METHODS	10 U.S. medical schools were pair-matched and randomized in a group-randomized controlled trial to evaluate whether a multi-modal educational ( MME ) intervention compared to traditional education ( TE ) will improve observed tobacco treatment skills .
METHODS	MME is primarily composed of TE approaches ( i.e. didactics ) plus a 1st year web-based course and preceptor-facilitated training during a 3rd year clerkship rotation .
METHODS	The primary outcome measure is an objective score on an Objective Structured Clinical Examination ( OSCE ) tobacco-counseling smoking case among 3rd year medical students from schools who implemented the MME or TE .
CONCLUSIONS	MSQuit is the first randomized to evaluate whether a tobacco treatment educational intervention implemented during medical school will improve medical students ' tobacco treatment skills .
CONCLUSIONS	We hypothesize that the MME intervention will better prepare students in tobacco dependence treatment as measured by the OSCE .
CONCLUSIONS	If a comprehensive tobacco treatment educational learning approach is effective , while also feasible and acceptable to implement , then medical schools may substantially influence skill development and use of the 5As among future physicians .

###24640582
BACKGROUND	PAD medical therapy has a number of limitations .
BACKGROUND	RLX showed promises in experimental model mainly through NO release .
BACKGROUND	Our study is the first to evaluate the efficacy and safety of RLX in PAD .
METHODS	Eligible PAD La fontaine IIa-IIb patients were randomized in 2 groups .
METHODS	Group A was treated with physical therapy plus oral pRLX , 20 ug b.i.d for 12 weeks , group B received physical therapy alone .
METHODS	Pain Free Walking Distance ( PFWD ) and Maximum Walking Distance ( MWD ) at 3 and 12 wks and at follow up 3 months after treatment interruption were performed .
RESULTS	The percentage increases of PFWD in group B were 23 + / - 9 , 65 + / - 17 , and 35 + / - 4 respectively at 3 and at 12 weeks , and 3 months after termination .
RESULTS	In Group A showed significantly higher percentage increases : 74 + / - 16 p < 0.01 , 168 + / - 28 p < 0.001 , and 122 + / - 15 p < 0.001 at the corresponding time points .
RESULTS	The percentage increases of MWD in the B group were 29 + / - 7 , 55 + / - 10 and 54 + / - 8 at the above time points , while in the A group were 55 + / - 10 p < 0.001 , and 99 + / - 12 p < 0.001 .
RESULTS	The RLX patients referred a better physical and mental status .
RESULTS	No adverse events during or after the treatment were recorded .
CONCLUSIONS	RLX resulted very effective in PAD .
CONCLUSIONS	Our results may suggest that the observed functional benefits should come not only from hemodynamic improvement but also from positive vascular remodeling .

###25448996
OBJECTIVE	To determine whether baseline Heidelberg Retina Tomograph ( HRT ) measurements of the optic disc are associated with the development of open-angle glaucoma ( OAG ) in individuals with ocular hypertension in the European Glaucoma Prevention Study ( EGPS ) .
METHODS	Retrospective analysis of a prospective , randomized , multicenter , double-masked , controlled clinical trial .
METHODS	There were 489 participants in the HRT Ancillary Study to the EGPS .
METHODS	Each baseline HRT parameter was assessed in univariate and multivariate proportional hazards models to determine its association with the development of OAG .
METHODS	Proportional hazards models were used to identify HRT variables that predicted which participants in the EGPS had developed OAG .
METHODS	Development of OAG was based on visual field and/or optic disc changes .
RESULTS	At a median follow-up time of about 5 years , 61 participants developed OAG .
RESULTS	In multivariate analyses , adjusting for randomization arm , age , baseline IOP , central corneal thickness , pattern standard deviation , and HRT disc area , the following HRT parameters were associated with the development of OAG : the `` outside normal limits '' classification of the Frederick Mikelberg ( FSM ) discriminant function ( hazard ratio [ HR ] 2.51 , 95 % confidence interval [ CI ] : 1.45-4 .35 ) , larger mean cup depth ( HR 1.64 , 95 % CI : 1.21-2 .23 ) , cup-to-disc area ratio ( HR 1.43 , 95 % CI : 1.14-1 .80 ) , linear cup-to-disc ratio ( HR 1.43 , 95 % CI : 1.13-1 .80 ) , cup area ( HR 1.33 , 95 % CI : 1.08-1 .64 ) , smaller rim area ( HR 1.33 , 95 % CI : 1.07-1 .64 ) , larger cup volume ( HR 1.30 , 95 % CI : 1.05-1 .61 ) , smaller rim volume ( HR 1.25 , 95 % CI : 1.01-1 .54 ) , larger maximum cup depth ( HR 1.18 , 95 % CI : 1.01-1 .36 ) , and cup shape measure ( HR 1.18 , 95 % CI : 1.01-1 .36 ) .
CONCLUSIONS	Several baseline HRT parameters , alone or in combination with baseline clinical and demographic factors , were significantly associated with the development of OAG among the EGPS participants .

###24846373
BACKGROUND	The integrated diagnostics ( ID ) algorithm is an implantable device-based tool that collates data pertaining to heart rhythm , heart rate , intrathoracic fluid status , and activity , producing a risk score that correlates with 30-day risk of heart failure ( HF ) hospitalization .
OBJECTIVE	We sought to validate the ID algorithm using the Resynchronization-Defibrillation for Ambulatory Heart Failure Trial .
METHODS	Diagnostic measures of the algorithm include OptiVol fluid index , nighttime heart rate , minutes of patient activity , heart rate variability , and combined measure of cardiac rhythm and biventricular pacing .
METHODS	Monthly evaluations of ID parameters were assessed for the development of HF symptoms and hospitalization for HF .
RESULTS	A total of 1224 patients were included : 741 ( 61 % ) with cardiac resynchronization therapy with defibrillator devices and 483 ( 39 % ) with implanted cardioverter-defibrillator only .
RESULTS	The mean age was 66 9 years , and 1013 ( 83 % ) were men .
RESULTS	A total of 37,861 months of follow-up data were available , with 258 HF hospitalizations ( event rate 0.68 % per month ) .
RESULTS	There were 33 HF hospitalizations during low-risk months ( 0.21 % per month ) , 123 during medium-risk months ( 0.66 % per month ) , and 102 during high-risk months ( 2.61 % per month ) .
RESULTS	Compared with low-risk months , and 95 % confidence intervals ) of HF hospitalizations during medium-risk months was 2.9 ( 2.0-4 .4 ) and during high-risk months was 10.7 ( 6.9-16 .6 ) .
RESULTS	Multivariable analysis demonstrated that each ID variable had independent association with HF hospitalization .
CONCLUSIONS	The risk of HF as determined by the ID algorithm correlated with HF hospitalization and several HF signs and symptoms among patients in the Resynchronization-Defibrillation for Ambulatory Heart Failure Trial .
CONCLUSIONS	This may present a useful adjunct to detect early signs of HF and adjust therapy to reduce morbidity and costs involved with hospital admission .

###24595629
OBJECTIVE	To compare effects of combinations of standard and intensive treatment of glycemia and either blood pressure ( BP ) or lipids in the Action to Control Cardiovascular Risk in Diabetes ( ACCORD ) trial .
METHODS	ACCORD enrolled 10,251 type 2 diabetes patients aged 40-79 years at high risk for cardiovascular disease ( CVD ) events .
METHODS	Participants were randomly assigned to hemoglobin A1c goals of < 6.0 % ( < 42 mmol/mol ; intensive glycemia ) or 7.0-7 .9 % ( 53-63 mmol/mol ; standard glycemia ) and then randomized a second time to either 1 ) systolic BP goals of < 120 mmHg ( intensive BP ) or < 140 mmHg ( standard BP ) or 2 ) simvastatin plus fenofibrate ( intensive lipid ) or simvastatin plus placebo ( standard lipid ) .
METHODS	Proportional hazards models were used to assess combinations of treatment assignments on the composite primary ( deaths due to CVD , nonfatal myocardial infarction [ MI ] , and nonfatal stroke ) and secondary outcomes .
RESULTS	In the BP trial , risk of the primary outcome was lower in the groups intensively treated for glycemia ( hazard ratio [ HR ] 0.67 ; 95 % CI 0.50-0 .91 ) , BP ( HR 0.74 ; 95 % CI 0.55-1 .00 ) , or both ( HR 0.71 ; 95 % CI 0.52-0 .96 ) compared with combined standard BP and glycemia treatment .
RESULTS	For secondary outcomes , MI was significantly reduced by intensive glycemia treatment and stroke by intensive BP treatment ; most other HRs were neutral or favored intensive treatment groups .
RESULTS	In the lipid trial , the general pattern of results showed no evidence of benefit of intensive regimens ( whether single or combined ) compared with combined standard lipid and glycemia treatment .
RESULTS	The mortality HR was 1.33 ( 95 % CI 1.02-1 .74 ) in the standard lipid/intensive glycemia group compared with the standard lipid/standard glycemia group .
CONCLUSIONS	In the ACCORD BP trial , compared with combined standard treatment , intensive BP or intensive glycemia treatment alone improved major CVD outcomes , without additional benefit from combining the two .
CONCLUSIONS	In the ACCORD lipid trial , neither intensive lipid nor glycemia treatment produced an overall benefit , but intensive glycemia treatment increased mortality .

###24695897
BACKGROUND	Nitric oxide ( NO ) is essential for the optimal perfusion of the heart and its vasculature .
BACKGROUND	NO may be insufficient in surgical patients because its precursor arginine is decreased , and the inhibitor of NO synthesis asymmetric dimethylarginine ( ADMA ) is increased .
BACKGROUND	Besides arginine , the presence of other amino acids essential for the proper metabolism of cardiac cells may be decreased too .
BACKGROUND	Supplementation of these amino acids with enteral and parenteral nutrition before , during , and after surgery may augment the myocardial and plasma arginine : ADMA ratio and availability of amino acids .
BACKGROUND	Myocardial glucose metabolism and nutritional conditioning may result in a reduction of cardiac injury and support rapid recovery after major surgery .
OBJECTIVE	We investigated the effect of nutrition before , during , and after surgery on amino acids and the myocardial arginine : ADMA ratio and its relation to myocardial glucose metabolism .
METHODS	In this trial , 33 patients who were undergoing off-pump coronary artery bypass grafting ( CABG ) were randomly assigned between enteral , parenteral , or no nutrition ( control ) from 2 d before , during , and until 2 d after surgery .
METHODS	Both enteral and parenteral solutions were prepared with commercially available products and included proteins or amino acids , glucose , vitamins , and minerals .
METHODS	Concentrations of amino acids including ADMA were analyzed in myocardial tissue and plasma samples .
METHODS	F-fluorodeoxyglucose positron emission tomography was performed before and after surgery to assess myocardial glucose metabolism .
RESULTS	The myocardial arginine : ADMA ratio increased during surgery and was significantly higher in the enteral and parenteral groups than in the control group [ median ( IQR ) : 115.0 ( 98.0-142 .2 ) ( P = 0.012 ) , 116.9 ( 100.3-135 .3 ) ( P = 0.004 ) , and 93.3 ( 82.7-101 .1 ) , respectively ] .
RESULTS	Furthermore , the change in the preoperative to postoperative plasma arginine : ADMA ratio correlated with the change in myocardial glucose metabolism in positron emission tomography ( r = 0.427 , P = 0.033 ) .
CONCLUSIONS	Enteral or parenteral nutrition before , during , and after CABG may positively influence myocardial glucose metabolism by increasing the plasma and myocardial arginine : ADMA ratio .

###25262168
BACKGROUND	Benefits of art participation after stroke are becoming increasingly recognized .
BACKGROUND	Qualitative studies suggest that participation in visual arts creative engagement interventions ( CEIs ) during rehabilitation after stroke may improve mood , self-esteem , hope and some aspects of physical recovery .
BACKGROUND	This study examines the feasibility of undertaking a randomized controlled trial of a CEI delivered by artists within in-patient stroke rehabilitation to test effectiveness .
METHODS	This trial is a two arm , single-blind , randomized controlled feasibility trial within in-patient stroke rehabilitation .
METHODS	We will recruit 80 patients receiving stroke rehabilitation in two stroke units in a health board area of Scotland ( 40 patients in each arm ) .
METHODS	Intervention arm participants will receive a visual-arts based CEI facilitated by experienced artists .
METHODS	Artists will follow an intervention protocol with specific components that enable participants to set , achieve and review artistic goals .
METHODS	Participants will receive up to eight intervention sessions , four within a group and four one-to-one with the artist .
METHODS	Control group participants will receive usual care only.Data collection will occur at baseline , post-intervention and three-month follow-up .
METHODS	Stroke-related health status is the primary outcome ; mood , self-esteem , self-efficacy , perceived recovery control and hope are secondary outcomes .
METHODS	Semi-structured interviews will be conducted with purposively selected patients , artists and healthcare staff to elicit views and experiences of the intervention and feasibility and acceptability of trial processes .
METHODS	Recruitment rates , retention rates and patient preference for art participation will also be collected .
METHODS	Data will indicate , with confidence intervals , the proportion of patients choosing or refusing participation in the CEI and will allow calculation of recruitment rates for a future definitive trial .
METHODS	Summary data will indicate potential variability , magnitude and direction of difference between groups .
METHODS	Findings will inform sample size calculations for a definitive trial .
METHODS	Thematic analysis of qualitative data will be managed using the Framework Approach .
METHODS	Framework is an analytical approach for qualitative data , commonly used in policy and medical research .
CONCLUSIONS	If shown to demonstrate effects , this intervention has the potential to address aspects of stroke recovery previously .
CONCLUSIONS	Not routinely addressed in rehabilitation .
BACKGROUND	Registered with Clinical Trials.Gov : NCT02085226 on 6th March 2014 .

###24776953
OBJECTIVE	The aim of this study was to evaluate the impact of two different therapeutic strategies in patients with partial seizures who were intractable to the first prescribed antiepileptic drug ( AED ) ; alternative monotherapy vs early add-on treatment .
METHODS	We conducted an open , cluster-randomised , prospective , controlled trial in patients with persistent partial seizures , despite treatment with one AED , who were never administered any other AEDs .
METHODS	Neurologists were randomised to two strategies : in group A , an alternative monotherapy with a second AED was employed ; in group B , add-on treatment with a second AED was employed .
METHODS	The primary outcome was the percentage of seizure-free patients during a two-month period after six months of treatment .
METHODS	The secondary outcomes were : ( i ) the percentage of patients achieving a 50 % reduction in the number of seizures at six months ; ( ii ) the quality of life based on the Quality Of Life In Epilepsy scale ; and ( iii ) tolerability .
RESULTS	A total of 143 neurologists were included and randomised , and 264 patients were evaluated .
RESULTS	At six months , the primary outcome was 51 % in group A and 45 % in group B ( p = 0.34 ) .
RESULTS	The percentage of patients achieving a 50 % reduction in the number of seizures at six months was 76 % in group A and 84 % in group B ( p = 0.53 ) .
RESULTS	The quality of life and the tolerability did not significantly differ between the two groups .
CONCLUSIONS	Alternative monotherapy or early treatment initiation with another AED drug resulted in similar efficacy , and the side effects associated with monotherapy and combined therapies were similar , which suggests that individual susceptibility is more important than the number and burden of AEDs used .

###26121789
BACKGROUND	This study was designed to evaluate the effects of perioperative administration of an isotonic electrolyte solution with 1 % glucose ( IT ) on blood sodium ( Na + ) and blood glucose ( BG ) concentrations in pediatric patients < 1-year-old undergoing plastic surgery in comparison with a conventional hypotonic electrolyte solution with 2.6 % glucose ( HT ) .
METHODS	Fifty Patients were randomly allocated to HT group and IT group .
METHODS	Na + and BG were measured at induction of anesthesia ( Tind ) , the end of surgery ( Tend ) , and 4 hours after surgery ( T4h ) .
RESULTS	Patient characteristics were similar for the 2 groups .
RESULTS	In the HT group , Na + at Tend insignificantly dropped compared with that at Tind , whereas in the IT group Na + was significantly elevated .
RESULTS	Na + at T4h significantly increased compared with that at Tend in each group .
RESULTS	No cases developed new dysnatremia or dysglycemia in IT group .
RESULTS	The incidence of hyponatremia at Tend was significantly lower in the IT group .
RESULTS	A positive correlation between intraoperative Na + concentration changes and the infusion duration was observed in the IT group .
CONCLUSIONS	Isotonic solution with 1 % glucose is suggested to be safe in infants during and after surgery .

###24715249
OBJECTIVE	Evaluate changes in active and passive function with onabotulinumtoxinA + standard of care within goal-oriented rehabilitation programmes in adults with focal post-stroke spasticity .
METHODS	Prospective , 24-week double-blind study with an open-label extension .
METHODS	Subjects were randomized to onabotulinumtoxinA + standard of care or placebo + standard of care , at baseline and at 12 weeks , if judged appropriate , with follow-up to 52 weeks .
METHODS	The primary endpoint was the number of patients achieving their principal active functional goal at 24 weeks ( or 10 weeks after an optional second injection ) .
METHODS	Secondary endpoints included achievement of a different active or a passive goal at this timepoint .
RESULTS	The intent-to-treat population comprised 273 patients .
RESULTS	The proportion of patients achieving their principal active functional goal and secondary active functional goal with onabotulinumtoxinA + standard of care was not statistically different from placebo + standard of care .
RESULTS	Significantly more patients achieved their secondary passive goal with onabotulinumtoxinA + standard of care ( 60.0 % ) vs. placebo + standard of care ( 38.6 % ) ( odds ratio , 2.46 ; 95 % confidence interval , 1.18-5 .14 ) as well as higher Goal Attainment Scaling levels for upper limb and ankle flexor subgroups .
CONCLUSIONS	Addition of onabotulinumtoxinA to standard of care as part of goal-oriented rehabilitation in post-stroke spasticity patients significantly increased passive goal achievement and was associated with higher levels of active function .

###25043153
BACKGROUND	Despite targeted antiemetics , data support an unmet need related to the management of delayed nausea and vomiting ( NV ) .
BACKGROUND	Promising pilot data informed this phase III trial evaluating gabapentin for delayed NV from highly emetogenic chemotherapy ( HEC ) .
METHODS	Participants were randomized to receive prophylactic treatment with 20 mg of dexamethasone and a 5HT3 receptor antagonist ( RA ) on the day of chemotherapy , followed by gabapentin 300 mg twice a day and dexamethasone ( dex ) or placebo and dex after HEC .
METHODS	Gabapentin/placebo was started the day of chemotherapy and continued through day 5 for the first chemotherapy cycle , whereas dex was titrated down on days 2-4 .
METHODS	The primary end point was complete response ( CR ) , defined as no emesis and no use of rescue medications on days 2-6 , using an NV diary .
METHODS	The percentages of those in each group with a CR were compared by Fisher 's exact test .
RESULTS	Four hundred thirty patients were enrolled in this study .
RESULTS	Forty-seven percent of patients in the gabapentin arm and 41 % in the placebo arm had a CR ( P = .23 ) .
RESULTS	Mean number of emesis episodes was < 0.5 daily , and mean nausea severity was < 2 ( mild ) .
RESULTS	In both arms , patient satisfaction with NV control was greater than 8 ( with 10 being perfectly satisfied ) .
RESULTS	There were no significant differences in unwanted side effects .
CONCLUSIONS	In this study , gabapentin did not significantly improve delayed NV .
CONCLUSIONS	Patients were satisfied with the control of their nausea and vomiting irrespective of arm .
CONCLUSIONS	The use of a 5HT3 RA and dexamethasone provided good control of nausea and vomiting for most patients .

###24429154
BACKGROUND	Previous studies suggested intravenous or nebulised magnesium sulphate ( MgSO ( 4 ) ) might improve respiratory function in patients with acute asthma .
BACKGROUND	We aimed to determine whether intravenous or nebulised MgSO ( 4 ) improve symptoms of breathlessness and reduce the need for hospital admission in adults with severe acute asthma .
METHODS	In our double-blind , placebo-controlled trial , we enrolled adults ( aged 16 years ) with severe acute asthma at emergency departments of 34 hospitals in the UK .
METHODS	We excluded patients with life-threatening features or contraindication to study drugs .
METHODS	We used a central randomisation system to allocate participants to intravenous MgSO ( 4 ) ( 2 g in 20 min ) or nebulised MgSO ( 4 ) ( three 500 mg doses in 1 h ) alongside standard therapy including salbutamol , or placebo control plus standard therapy alone .
METHODS	We assessed two primary outcome measures in all eligible participants who started treatment , according to assigned treatment group : the proportion of patients admitted to hospital within 7 days and breathlessness measured on a 100 mm visual analogue scale ( VAS ) in the 2 h after initiation of treatment .
METHODS	We adjusted for multiple testing using Simes 's method .
METHODS	The trial stopped before recruitment was completed because funding expired .
METHODS	This study is registered , number ISRCTN04417063 .
RESULTS	Between July 30 , 2008 , and June 30 , 2012 , we recruited 1109 ( 92 % ) of 1200 patients proposed by the power calculation .
RESULTS	261 ( 79 % ) of 332 patients allocated nebulised MgSO ( 4 ) were admitted to hospital before 7 days , as were 285 ( 72 % ) of 394 patients allocated intravenous MgSO ( 4 ) and 281 ( 78 % ) of 358 controls .
RESULTS	Breathlessness was assessed in 296 ( 89 % ) patients allocated nebulised MgSO ( 4 ) , 357 ( 91 % ) patients allocated intravenous MgSO ( 4 ) , and 323 ( 90 % ) controls .
RESULTS	Rates of hospital admission did not differ between patients treated with either form of MgSO ( 4 ) compared with controls or between those treated with nebulised MgSO ( 4 ) and intravenous MgSO ( 4 ) .
RESULTS	Change in VAS breathlessness did not differ between active treatments and control , but change in VAS was greater for patients in the intravenous MgSO ( 4 ) group than it was in the nebulised MgSO ( 4 ) group ( 51 mm , 08 to 94 ; p = 0019 ) .
RESULTS	Intravenous or nebulised MgSO ( 4 ) did not significantly decrease rates of hospital admission and breathlessness compared with placebo : intravenous MgSO ( 4 ) was associated with an odds ratio of 073 ( 95 % CI 051 to 104 ; p = 0083 ) for hospital admission and a change in VAS breathlessness of 26 mm ( -16 to 68 ; p = 0231 ) compared with placebo ; nebulised MgSO ( 4 ) was associated with an odds ratio of 096 ( 065 to 140 ; p = 0819 ) for hospital admission and a change in VAS breathlessness of -26 mm ( -70 to 18 ; p = 0253 ) compared with placebo .
CONCLUSIONS	Our findings suggest nebulised MgSO ( 4 ) has no role in the management of severe acute asthma in adults and at best suggest only a limited role for intravenous MgSO ( 4 ) in this setting .
BACKGROUND	UK National Institute for Health Research Health Technology Assessment Programme .

###25827654
OBJECTIVE	To test the effect of 8 weeks of lower body resistance training on hyperglycemia and dyslipidemia , which may be prevalent among nonelderly , nondiabetic , chronically disabled stroke patients .
METHODS	Randomized controlled study .
METHODS	Outpatient clinics of rehabilitation centers .
METHODS	Nonelderly , nondiabetic , chronically disabled stroke subjects ( N = 56 ) were enrolled and randomly assigned to an experimental group ( n = 28 ) and a control group ( n = 28 ) .
METHODS	Lower body resistance training was performed by subjects in the experimental group 3 times a week for 8 weeks .
METHODS	The control group was given duration-matched stretch exercises .
METHODS	Fasting glucose level , fasting insulin level , 2-hour blood glucose level during oral glucose tolerance test , homeostasis model assessment of insulin resistance ( HOMA-IR ) , glycosylated hemoglobin ( Hb A1c ) , total triglyceride level , total cholesterol level , high-density lipoprotein ( HDL ) cholesterol level , low-density lipoprotein ( LDL ) cholesterol level , body mass index , lower limb muscle strength , and Fugl-Meyer motor score .
RESULTS	Before the intervention , 34 subjects ( 60.7 % ) had hyperglycemia and 38 ( 67.9 % ) had dyslipidemia .
RESULTS	Fifty-one subjects finished the study .
RESULTS	Subjects in the experimental group ( n = 26 ) showed significant improvements in fasting insulin and 2-hour blood glucose levels ; HOMA-IR ; total cholesterol , HDL cholesterol , and LDL cholesterol levels ; and muscle strength compared with control subjects ( n = 25 ) after the intervention ( P < .05 ) .
CONCLUSIONS	Resistance training may play a significant role in improving hyperglycemia and dyslipidemia , which are frequently present among nonelderly , nondiabetic , chronically disabled stroke patients .

###24630545
BACKGROUND	There is little evidence for the optimal form of nonoperative treatment in the management of frozen shoulder .
BACKGROUND	This study assesses the efficacy of current physiotherapy strategies .
METHODS	All primary care referrals of frozen shoulder to our physiotherapy department were included during a 12-month period .
METHODS	Of these referrals , 17 % met the inclusion criteria for primary idiopathic frozen shoulder .
METHODS	The 75 patients were randomly assigned to 1 of 3 groups : group exercise class , individual physiotherapy , and home exercises alone .
METHODS	A single independent physiotherapist , who was blinded to the treatment groups , made all assessments .
METHODS	Range of motion , Constant score , Oxford Shoulder Score , Short Form 36 , and Hospital Anxiety and Disability Scale ( HADS ) outcome measures were performed at baseline , 6 weeks , 6 months , and 1 year .
RESULTS	The exercise class group improved from a mean Constant score of 39.8 at baseline to 71.4 at 6 weeks and 88.1 at 1 year .
RESULTS	There was a significant improvement in shoulder symptoms on Oxford and Constant scores ( P < .001 ) .
RESULTS	This improvement was greater than with individual physiotherapy or home exercises alone ( P < .001 ) .
RESULTS	The improvement in range of motion was significantly greater in both physiotherapy groups over home exercises ( P < .001 ) .
RESULTS	HADS scores significantly improved during the course of treatment ( P < .001 ) .
RESULTS	The improvement in HADS anxiety score was significantly greater in both physiotherapy intervention groups than in home exercises alone .
CONCLUSIONS	A hospital-based exercise class can produce a rapid recovery from a frozen shoulder with a minimum number of visits to the hospital and is more effective than individual physiotherapy or a home exercise program .

###24708394
OBJECTIVE	Primary aim of this study was to evaluate if patient morbidity was improved by diminishing graft thickness and height ; secondary objective was to evaluate if such graft modifications influence root coverage and aesthetic outcomes .
METHODS	60 Miller class I and II gingival recessions ( GR ) ( 3 mm in depth ) were treated with the coronally advanced flap plus extraoral de-epithelialized free gingival graft ( FGG ) .
METHODS	In 30 randomly selected control GRs ( `` big graft group '' ) , the FGG thickness was 2 mm and the height was equal to bone dehiscence ( BD ) ; in the other 30 test defects ( `` small graft group '' ) , the thickness of the FGG was < 2 mm and the height was 4 mm .
METHODS	The post-operative patient morbidity was assessed 1 week after the surgery .
METHODS	The clinical and aesthetic evaluations were performed 1 year after the surgery .
RESULTS	Lower analgesic assumption , better post-operative course evaluations , better patient colour match scores and better periodontist aesthetic assessments were reported in the `` small graft '' group .
RESULTS	No statistically significant differences were demonstrated between the two groups in terms of recession reduction , CRC and increase in KTH .
RESULTS	Greater GT increase was obtained in the control-treated sites .
CONCLUSIONS	Coronally advanced flap plus CTG of reduced thickness and height was associated with less patient morbidity , better aesthetic evaluations with no difference in RC outcomes .

###24274358
BACKGROUND	The purpose of this study was to assess the effect of 8-weeks ingestion of a commercialized joint pain dietary supplement ( Instaflex Joint Support , Direct Digital , Charlotte , NC ) compared to placebo on joint pain , stiffness , and function in adults with self-reported joint pain .
BACKGROUND	Instaflex is a joint pain supplement containing glucosamine sulfate , methylsufonlylmethane ( MSM ) , white willow bark extract ( 15 % salicin ) , ginger root concentrate , boswella serrata extract ( 65 % boswellic acid ) , turmeric root extract , cayenne , and hyaluronic acid .
METHODS	Subjects included 100 men and women , ages 50-75 years , with a history ( > 3 months ) of joint pain , and were randomized to Instaflex or placebo ( 3 colored gel capsules per day for 8 weeks , double-blind administration ) .
METHODS	Subjects agreed to avoid the use of non-steroidal anti-inflammatory drugs ( NSAID ) and all other medications and supplements targeted for joint pain .
METHODS	Primary outcome measures were obtained pre - and post-study and included joint pain severity , stiffness , and function ( Western Ontario and McMaster Universities [ WOMAC ] ) , and secondary outcome measures included health-related quality of life ( Short Form 36 or SF-36 ) , systemic inflammation ( serum C-reactive protein and 9 plasma cytokines ) , and physical function ( 6-minute walk test ) .
METHODS	Joint pain symptom severity was assessed bi-weekly using a 12-point Likert visual scale ( 12-VS ) .
RESULTS	Joint pain severity was significantly reduced in Instaflex compared to placebo ( 8-week WOMAC , 37 % versus 16 % , respectively , interaction effect P = 0.025 ) , with group differences using the 12-VS emerging by week 4 of the study ( interaction effect , P = 0.0125 ) .
RESULTS	Improvements in ability to perform daily activities and stiffness scores in Instaflex compared to placebo were most evident for the 74 % of subjects reporting knee pain ( 8-week WOMAC function score , 39 % versus 14 % , respectively , interaction effect P = 0.027 ; stiffness score , 30 % versus 12 % , respectively , interaction effect P = 0.081 ) .
RESULTS	Patterns of change in SF-36 , systemic inflammation biomarkers , and the 6-minute walk test did not differ significantly between groups during the 8-week study
CONCLUSIONS	Results from this randomized , double blind , placebo-controlled community trial support the use of the Instaflex dietary supplement in alleviating joint pain severity in middle-aged and older adults , with mitigation of difficulty performing daily activities most apparent in subjects with knee pain .

###24694475
OBJECTIVE	The aim of this study was to investigate the effects of two different treatment regimes in patients with IgA nephropathy ( IgAN ) : steroids alone and in combination with a medium dose of cyclosporine A ( CsA ) .
METHODS	Forty-eight IgAN patients 18-69 years of age with proteinuria > 1.0 g/24 hours and an estimated glomerular filtration rate ( eGFR ) of > 30 mL/min/1 .73 m ( 2 ) were randomly given either steroids alone ( methylprednisolone ( MP ) group ; n = 25 ) or steroids plus CsA treatment ( combination group ; n = 23 ) .
METHODS	The primary endpoint was the reduction of proteinuria by 50 % or more of the baseline value .
METHODS	The secondary endpoint was an increase in the baseline serum creatinine level of 50 % or a decrease in the baseline eGFR of 25 % .
RESULTS	After 12 months of treatment , all patients in the combination group and 87.50 % of the patients in the MP group reached the primary endpoint .
RESULTS	The complete remission rates in the combination group and MP group were 50.0 % and 45.83 % , respectively .
RESULTS	The level of urinary protein excretion declined from 3.17 3.25 g/24 hours to 0.36 0.23 g/24 hours ( p < 0.001 ) in the combination group and from 2.60 2.03 g/24 hours to 0.53 0.71 g/24 hours ( p < 0.001 ) in the MP group .
RESULTS	Two patients in the combination group reached the secondary endpoint , with a decrease in the eGFR of 25 % from the baseline value , while no patients in the MP group achieved this goal .
RESULTS	The patients in the combination group exhibited significant improvements in the eGFR after nine months ( 90.16 28.78 vs. 80.46 22.73 mL/min .1.73 m ( 2 ) , p = 0.011 ) , while the patients in the MP group showed significant increases in the eGFR after six months of treatment ( 92.18 22.71 to 81.63 18.36 mL/min/1 .73 m ( 2 ) , p = 0.019 ) .
RESULTS	Four patients ( 8.33 % ) developed severe pneumonia during treatment .
CONCLUSIONS	Both the full dose of steroids alone and combined treatment with steroids and a medium dose of CsA remarkably reduced the levels of proteinuria and ameliorated the renal function in the IgAN patients .
CONCLUSIONS	Infection was the most serious complication during the treatment .

###24801567
BACKGROUND	To assess the effect of aging on stretch reflex modulation during walking , soleus H-reflexes obtained in 15 middle-aged ( mean age 56.46.9 years ) and 15 young ( mean age 23.73.9 years ) subjects were compared .
METHODS	The H-reflex amplitude , muscle activity ( EMG ) of the soleus and tibialis anterior muscles , and EMG/H-reflex gain were measured during 4-km/h treadmill walking .
RESULTS	The normalized H-reflex amplitude was lower in the swing phase for the middle-aged group , and there was no difference in muscle activity .
RESULTS	EMG/H-reflex gain did not differ between groups .
CONCLUSIONS	H-reflex amplitude during walking was affected by aging , and changes during the swing phase could be seen in the middle-aged subjects .
CONCLUSIONS	Subdividing the 2 age groups into groups of facilitated or suppressed swing-phase H-reflex revealed that the H-reflex amplitude modulation pattern in the group with facilitated swing-phase H-reflex may be influenced by aging .

###24998108
OBJECTIVE	The aim of this randomized , prospective and double blinded study is to investigate effects of different esmolol use on hemodynamic response of laryngoscopy , endotracheal intubation and sternotomy in coronary artery bypass graft surgery .
METHODS	After approval of local ethics committee and patients ' written informed consent , 45 patients were randomized into three groups equally .
METHODS	In Infusion Group ; from 10 min before intubation up to 5th minute after sternotomy , 0.5 mg/kg/min esmolol infusion , in Bolus Group ; 2 min before intubation and sternotomy 1.5 mg/kg esmolol IV bolus and in Control Group ; % 0.9 NaCl was administered .
METHODS	All demographic parameters were recorded .
METHODS	Heart rate and blood pressure were recorded before infusion up to anesthesia induction in every minute , during endotracheal intubation , every minute for 10 minutes after endotracheal intubation and before , during and after sternotomy at first and fifth minutes .
RESULTS	While area under curve ( AUC ) ( SAPtime ) was being found more in Group B and C than Group I , AUC ( SAPTint and Tst ) and AUC ( SAPT2 ) was found more in Group B and C than Group I ( p < 0.05 ) .
RESULTS	Moreover AUC ( HRTst ) was found less in Group B than Group C but no significant difference was found between Group B and Group I.
CONCLUSIONS	This study highlights that esmolol infusion is more effective than esmolol bolus administration on controlling systolic arterial pressure during endotracheal intubation and sternotomy in CABG surgery .

###24920349
OBJECTIVE	The aim of this study was to determine whether intermittent ambulatory treatment with levosimendan would improve functional capacity , quality of life , and event-free survival in patients with advanced heart failure .
RESULTS	This was a prospective , randomized , double-blind , placebo-controlled , multicentre , parallel-group trial of pulsed infusions of levosimendan in 120 outpatients with advanced heart failure ( EF 35 % , NYHA class III or IV ) .
RESULTS	The study was conducted at 11 centres in Austria , Greece , and Germany .
RESULTS	Levosimendan ( 0.2 g/kg/min ) or placebo was administered for 6 h at 2-week intervals over 6 weeks , in addition to standard care therapy .
RESULTS	The primary outcome was the proportion of patients with a 20 % improvement in the 6 min walk test and a 15 % score increase on the Kansas City Cardiomyopathy Questionnaire at the end of the 24-week study period .
RESULTS	Secondary outcomes included event-free survival after 24 weeks .
RESULTS	Analyses were performed on an intention-to-treat basis .
RESULTS	The primary endpoint was reached in 19 % of patients receiving levosimendan and 15.8 % of patients receiving placebo ( odds ratio 1.25 ; 95 % confidence interval 0.44-3 .59 ; P = 0.810 ) .
RESULTS	Cardiac death ( four vs. one ) , heart transplants ( two vs. one ) , and acute heart failure ( 14 vs. nine ) were more frequent with placebo as compared with levosimendan .
RESULTS	The incidence of side effects was comparable between groups .
CONCLUSIONS	Intermittent ambulatory treatment with levosimendan in patients with advanced heart failure did not improve significantly functional capacity or quality of life as compared with placebo .
CONCLUSIONS	An adequately powered , event-driven trial is warranted to enlarge on our findings .
BACKGROUND	NCT01065194 .

###25496296
BACKGROUND	This mixed methods study explored the characteristics of and experiences with perceived discrimination in an ethnically diverse urban sample of adults experiencing homelessness and mental illness .
METHODS	Data were collected in Toronto , Ontario , as part of a 4-year national randomized field trial of the Housing First treatment model .
METHODS	Rates of perceived discrimination were captured from survey questions regarding perceived discrimination among 231 ethnoracially diverse participants with moderate mental health needs .
METHODS	The qualitative component included thirty six in-depth interviews which explored how individuals who bear these multiple identities of oppression navigate stigma and discrimination , and what affects their capacity to do so .
RESULTS	Quantitative analysis revealed very high rates of perceived discrimination related to : homelessness/poverty ( 61.5 % ) , race/ethnicity/skin colour ( 50.6 % ) and mental illness/substance use ( 43.7 % ) .
RESULTS	Immigrants and those who had been homeless three or more years reported higher perceived discrimination on all three domains .
RESULTS	Analysis of qualitative interviews revealed three common themes related to navigating these experiences of discrimination among participants : 1 ) social distancing ; 2 ) old and new labels/identities ; and , 3 ) ` homeland ' cultures .
CONCLUSIONS	These study findings underscore poverty and homelessness as major sources of perceived discrimination , and expose underlying complexities in the navigation of multiple identities in responding to stigma and discrimination .
BACKGROUND	Current Controlled Trials ISRCTN42520374 .
BACKGROUND	Registered 18 August 2009 .

###25200399
OBJECTIVE	To evaluate the impact of complement factor H ( CFH ) and age-related maculopathy susceptibility 2 ( ARMS2 ) risk alleles on the observed response to components of the Age-Related Eye Disease Study ( AREDS ) formulation .
METHODS	Genetic and statistical subgroup analysis of a randomized , prospective clinical trial .
METHODS	White patients from the AREDS with category 3 or 4 age-related macular degeneration ( AMD ) with available DNA ( n = 989 ) .
METHODS	Four genotype groups based on CFH and ARMS2 risk allele number were defined .
METHODS	Progression to advanced AMD was analyzed by genotype and treatment using Cox proportionate hazards estimates and 7-year events .
METHODS	The effect of predefined genotype group on treatment-specific progression to advanced AMD .
RESULTS	Patients with 2 CFH risk alleles and no ARMS2 risk alleles progressed more with zinc-containing treatment compared with placebo , with a hazard ratio ( HR ) of 3.07 ( P = 0.0196 ) for zinc and 2.73 ( P = 0.0418 ) for AREDS formulation ( AF ) .
RESULTS	Seven-year treatment-specific progression rates were : placebo , 17.0 % ; zinc , 43.2 % ( P = 0.023 ) ; and AF , 40.2 % ( P = 0.039 ) .
RESULTS	Patients with 0 or 1 CFH risk alleles and 1 or 2 ARMS2 risk alleles benefited from zinc-containing treatment compared with placebo , with an HR of 0.514 for zinc ( P = 0.012 ) and 0.569 for AF ( P = 0.0254 ) .
RESULTS	Seven-year treatment-specific AMD progression rates were as follows : placebo , 43.3 % ; zinc , 25.2 % ( P = 0.020 ) ; and AF , 27.3 % ( P = 0.011 ) .
RESULTS	Zinc and AF treatment each interacted statistically with these 2 genotype groups under a Cox model , with P values of 0.000999 and 0.00366 , respectively .
RESULTS	For patients with 0 or 1 CFH risk alleles and no ARMS2 risk alleles , neither zinc-containing treatment altered progression compared with placebo , but treatment with antioxidants decreased progression ( HR , 0.380 ; P = 0.034 ) .
RESULTS	Seven-year progression with placebo was 22.6 % and with antioxidants was 9.17 % ( P = 0.033 ) .
RESULTS	For patients with 2 CFH risk alleles and 1 or 2 ARMS2 risk alleles , no treatment was better than placebo ( 48.4 % ) .
CONCLUSIONS	The benefit of the AREDS formulation seems the result of a favorable response by patients in only 1 genotype group , balanced by neutral or unfavorable responses in 3 genotype groups .

###25223208
OBJECTIVE	To evaluate the effect of ocular draping on rates of bacterial contamination of the ocular surface immediately after intravitreal injection using a plate-type eyelid speculum .
METHODS	Twelve institutions participated in this prospective randomized study .
METHODS	Patients from each institution undergoing intravitreal injections were randomly assigned to 2 groups , with and without ocular draping .
METHODS	Following each institution 's standard protocol for aseptic preparation , intravitreal injection was performed using a plate-type eyelid speculum designed for intravitreal injections with or without draping .
METHODS	Immediately after the intravitreal injection , a cotton swab was used to obtain a sample at the injection site and sent for bacterial culture .
RESULTS	Of 262 eyes involved in the study , cultures were positive in five eyes ( 1.9 % ) using standard methods and positive in an additional 25 eyes ( 9.5 % ) using methods to increase culture sensitivity .
RESULTS	There was no significant difference in the combined rate of bacterial contamination between the 2 groups ( p = 0.561 , Fisher 's exact test ) .
CONCLUSIONS	Ocular draping did not decrease the rate of bacterial contamination immediately after intravitreal injection performed using a plate-type eyelid speculum .

###24246826
OBJECTIVE	To examine the effect of donor age and other perioperative factors on long-term endothelial cell loss after penetrating keratoplasty ( PKP ) .
METHODS	Multicenter , prospective , double-masked clinical trial .
METHODS	We included 176 participants from the Cornea Donor Study cohort who had not experienced graft failure 10 years after PKP for a moderate risk condition ( principally Fuchs ' dystrophy or pseudophakic/aphakic corneal edema ) .
METHODS	Corneas from donors 12 to 75 years old were assigned to participants using a randomized approach , without respect to recipient factors .
METHODS	Surgery and postoperative care were performed according to the surgeons ' usual routines .
METHODS	Images of the central endothelium were obtained preoperatively and at intervals for 10 years postoperatively .
METHODS	Images were analyzed by a central image analysis reading center to determine endothelial cell density ( ECD ) .
METHODS	Endothelial cell density at 10 years .
RESULTS	Among study participants with a clear graft at 10 years , the 125 who received a cornea from a donor 12 to 65 years old experienced a median cell loss of 76 % , resulting in a 10-year median ECD of 628 cells/mm ( 2 ) ( interquartile range [ IQR ] , 522-850 cells/mm ( 2 ) ) , whereas the 51 who received a cornea from a donor 66 to 75 years old experienced a cell loss of 79 % , resulting in a median 10-year ECD of 550 cells/mm ( 2 ) ( IQR , 483-694 cells/mm ( 2 ) ; P adjusted for baseline ECD = 0.03 ) .
RESULTS	In addition to younger donor age , higher ECD values were significantly associated with higher baseline ECD ( P < 0.001 ) and larger donor tissue size ( P < 0.001 ) .
RESULTS	Forty-two of the 176 participants ( 24 % ) had an ECD of < 500 cells/mm ( 2 ) at 10 years and only 24 ( 14 % ) had an ECD of > 1000 cells/mm ( 2 ) .
CONCLUSIONS	Substantial cell loss occurs in eyes with a clear graft 10 years after PKP , with the rate of cell loss being slightly greater with older donor age .
CONCLUSIONS	Greater preoperative ECD and larger donor tissue size are associated with higher ECD at 10 years .

###24813558
BACKGROUND	Nesfatin-1 is an anorexigenic hormone suggested to regulate obesity .
OBJECTIVE	To investigate the relationship between nesfatin-1 level and anthropometric and metabolic parameters in obese patients , and examine the change in plasma nesfatin-1 level after acupuncture treatment .
METHODS	64 obese adult patients without diabetes and 58 normal weight control subjects were enrolled in this study .
METHODS	The obese patients were randomly divided into an acupuncture plus diet group ( n = 32 ) and a diet only group ( n = 32 ) .
METHODS	Measurements were repeated after 45days .
RESULTS	Body mass index ( BMI ) , waist and hip circumferences , serum insulin , lipoprotein and insulin resistance measures were significantly higher , and plasma nesfatin-1 level was significantly lower , in obese patients than in normal weight controls .
RESULTS	In addition , negative correlations were found between plasma nesfatin-1 level and BMI , waist and hip circumferences .
RESULTS	Weight reduction in participants after acupuncture and diet restriction was 7.0 % and 4.3 % , respectively .
RESULTS	Plasma nesfatin-1 level increased from 2.751.16 to 3.441.28 ng/mL and from 2.861.07 to 3.231.06 ng/mL in acupuncture and diet groups , respectively ; the difference was significant , p < 0.05 .
CONCLUSIONS	Plasma nesfatin-1 level is reduced in obese adults , and is increased after acupuncture .
CONCLUSIONS	The beneficial effect of acupuncture on obesity is associated with increased plasma nesfatin-1 level .

###24504819
OBJECTIVE	Fibromyalgia and major depressive disorder ( MDD ) frequently co-occur .
OBJECTIVE	Quetiapine fumarate extended-release ( quetiapine XR ) has demonstrated efficacy in the treatment of MDD and has been shown to have analgesic properties in patients with depression .
OBJECTIVE	The primary objectives of this study were to evaluate the effects of quetiapine XR on depressive and pain symptoms in patients with MDD and comorbid fibromyalgia , and to assess its safety and tolerability .
METHODS	This was an 8-week , single-center , double-blind , randomized , controlled trial .
METHODS	A total of 120 nonpsychotic adult outpatients who fulfilled the Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition diagnostic criteria for MDD and whose diagnosis of fibromyalgia was confirmed according to the American College of Rheumatology criteria were enrolled .
METHODS	The primary end point was the mean change from baseline to week 8 on the 17-item Hamilton Depression Rating ( HAM-D ) scale .
METHODS	Secondary end points included other depression-rating scores , pain scores , fibromyalgia scores , measures of quality of life and global functioning , and adverse events .
RESULTS	The mean change in the HAM-D score from baseline to week 8 was significantly greater in the quetiapine XR group compared with the placebo group ( -10.0 versus -5.8 ; P = 0.001 ) .
RESULTS	Improvements in most secondary outcomes were also significantly greater in the quetiapine XR group .
RESULTS	Quetiapine XR was generally well tolerated .
CONCLUSIONS	This study is the first to demonstrate that measures of depression , pain , and quality of life are significantly improved with quetiapine XR compared with placebo in patients with a dual diagnosis of MDD and fibromyalgia .

###24969152
OBJECTIVE	This article reports the effects of three evidence-based interventions of varying intensity , each designed to improve outcomes of hospitalized cognitively impaired older adults .
METHODS	In this comparative effectiveness study , 202 older adults with cognitive impairment ( assessed within 24 h of index hospitalization ) were enrolled at one of three hospitals within an academic health system .
METHODS	Each hospital was randomly assigned one of the following interventions : Augmented Standard Care ( ASC ; lower dose : n = 65 ) , Resource Nurse Care ( RNC ; medium dose : n = 71 ) or the Transitional Care Model ( TCM ; higher dose : n = 66 ) .
METHODS	Since randomization at the patient level was not feasible due to potential contamination , generalized boosted modeling that estimated multigroup propensity score weights was used to balance baseline patient characteristics between groups .
METHODS	Analyses compared the three groups on time with first rehospitalization or death , the number and days of all-cause rehospitalizations per patient and functional status through 6-month postindex hospitalization .
RESULTS	In total , 25 % of the ASC group were rehospitalized or died by day 33 compared with day 58 for the RNC group versus day 83 for the TCM group .
RESULTS	The largest differences between the three groups on time to rehospitalization or death were observed early in the Kaplan-Meier curve ( at 30 days : ASC = 22 % vs RNC = 19 % vs TCM = 9 % ) .
RESULTS	The TCM group also demonstrated lower mean rehospitalization rates per patient compared with the RNC ( p < 0.001 ) and ASC groups ( p = 0.06 ) at 30 days .
RESULTS	At 90-day postindex hospitalization , the TCM group continued to demonstrate lower mean rehospitalization rates per patient only when compared with the ASC group ( p = 0.02 ) .
RESULTS	No significant group differences in functional status were observed .
CONCLUSIONS	Findings suggest that the TCM intervention , compared with interventions of lower intensity , has the potential to decrease costly resource use outcomes in the immediate postindex hospitalization period among cognitively impaired older adults .

###24462229
BACKGROUND	Although electroconvulsive therapy ( ECT ) is the most effective acute antidepressant intervention , sustained response rates are low .
BACKGROUND	It has never been systematically assessed whether psychotherapy , continuation ECT , or antidepressant medication is the most efficacious intervention to maintain initial treatment response .
METHODS	In a prospective , randomized clinical trial , 90 inpatients with major depressive disorder ( MDD ) were treated with right unilateral ultra-brief acute ECT .
METHODS	Electroconvulsive therapy responders received 6 months guideline-based antidepressant medication ( MED ) and were randomly assigned to add-on therapy with cognitive-behavioral group therapy ( CBT-arm ) , add-on therapy with ultra-brief pulse continuation electroconvulsive therapy ( ECT-arm ) , or no add-on therapy ( MED-arm ) .
METHODS	After the 6 months of continuation treatment , patients were followed-up for another 6 months .
METHODS	The primary outcome parameter was the proportion of patients who remained well after 12 months .
RESULTS	Of 90 MDD patients starting the acute phase , 70 % responded and 47 % remitted to acute ECT .
RESULTS	After 6 months of continuation treatment , significant differences were observed in the three treatment arms with sustained response rates of 77 % in the CBT-arm , 40 % in the ECT-arm , and 44 % in the MED-arm .
RESULTS	After 12 months , these differences remained stable with sustained response rates of 65 % in the CBT-arm , 28 % in the ECT-arm , and 33 % in the MED-arm .
CONCLUSIONS	These results suggest that ultra-brief pulse ECT as a continuation treatment correlates with low sustained response rates .
CONCLUSIONS	However , the main finding implicates cognitive-behavioral group therapy in combination with antidepressants might be an effective continuation treatment to sustain response after successful ECT in MDD patients .

###25557016
BACKGROUND	Spinal anesthesia ( SA ) is usually associated with hypotension in pregnant women .
BACKGROUND	We sought to assess the influence of various maternal positions on SA-induced hypotension
METHODS	The study population comprised 99 women at full-term gestation scheduled for elective cesarean section .
METHODS	They were randomized into 3 equal groups : the LL group , in which the patient was placed in the full left-lateral position until the start of surgery with the Whitacre needle bevel oriented laterally ; the LS group , in which the patient was placed in the full left-lateral position initially and then shifted to the left-tilt supine position with the needle bevel oriented laterally ; and the CS group , in which the patient was initially placed in the full left-lateral position and then shifted to the left-tilt supine position with the needle oriented in the cephalad direction .
RESULTS	The incidences of hypotension in the LL , LS , and CS groups were 9.7 % , 54.8 % , and 56.3 % , respectively .
RESULTS	Ephedrine requirements were lower in the LL group than in the LS group ( P < 0.01 ) .
CONCLUSIONS	The maternal position during the induction of anesthesia played an important role in the development of hypotension during cesarean delivery .

###24886206
BACKGROUND	Adolescent smoking is still highly prevalent in Denmark .
BACKGROUND	One in four 13-year olds indicates that they have tried to smoke , and one in four 15-year olds answer that they smoke regularly .
BACKGROUND	Smoking is more prevalent in socioeconomically disadvantaged populations in Denmark as well as in most Western countries .
BACKGROUND	Previous school-based programs to prevent smoking have shown contrasting results internationally .
BACKGROUND	In Denmark , previous programs have shown limited or no effect .
BACKGROUND	This indicates a need for developing a well-designed , comprehensive , and multi-component intervention aimed at Danish schools with careful implementation and thorough evaluation.This paper describes X : IT , a study including 1 ) the development of a 3-year school-based multi-component intervention and 2 ) the randomized trial investigating the effect of the intervention .
BACKGROUND	The study aims at reducing the prevalence of smoking among 13 to 15-year olds by 25 % .
METHODS	The X : IT study is based on the Theory of Triadic Influences .
METHODS	The theory organizes factors influencing adolescent smoking into three streams : cultural environment , social situation , and personal factors .
METHODS	We added a fourth stream , the community aspects .
METHODS	The X : IT program comprises three main components : 1 ) smoke-free school premises , 2 ) parental involvement including smoke-free dialogues and smoke-free contracts between students and parents , and 3 ) a curricular component .
METHODS	The study encompasses process - and effect-evaluations as well as health economic analyses .
METHODS	Ninety-four schools in 17 municipalities were randomly allocated to the intervention ( 51 schools ) or control ( 43 schools ) group .
METHODS	At baseline in September 2010 , 4,468 year 7 students were eligible of which 4,167 answered the baseline questionnaire ( response rate = 93.3 % ) .
CONCLUSIONS	The X : IT study is a large , randomized controlled trial evaluating the effect of an intervention , based on components proven to be efficient in other Nordic settings .
CONCLUSIONS	The X : IT study directs students , their parents , and smoking prevention policies at the schools .
CONCLUSIONS	These elements have proven to be effective tools in preventing smoking among adolescents .
CONCLUSIONS	Program implementation is thoroughly evaluated to be able to add to the current knowledge of the importance of implementation .
CONCLUSIONS	X : IT creates the basis for thorough effect and process evaluation , focusing on various social groups .
BACKGROUND	Current Controlled Trials ISRCTN77415416 .

###24693973
BACKGROUND	Advanced oxidation protein products ( AOPP ) are newly identified efficient oxidative stress biomarkers .
BACKGROUND	In a longitudinal birth cohort the effects were investigated of genetic polymorphisms in five oxidative pathway genes on AOPP levels .
METHODS	This study is part of a three-arm randomized , double-blind , placebo-controlled trial .
METHODS	Three hundred and twelve children were included in the present study with AOPP levels measured at 2.5 , 5.5 , 10.5 , 15 and 24 months of age .
METHODS	Twelve polymorphisms were genotyped in five oxidative stress pathway genes : glutathione reductase ( GSR ) , glutamylcysteine synthetase ( GCLC ) , glutathione S-transferase ( GST ) P1 , haem oxygenase 1 ( HMOX1 ) and superoxide dismutase 2 ( SOD2 ) in 298 children .
METHODS	There were 284 children assessed for anaemia and clinical malaria infection at the age of 24 months .
RESULTS	Two principal components ( PCA1 and PCA2 ) were derived from the AOPP levels measured at the five time points .
RESULTS	PCA1 was significantly associated with anaemia ( p = 0.0002 ) , and PCA2 with clinical malaria infection ( p = 0.047 ) .
RESULTS	In the K-Means Cluster Analysis based on levels of AOPP , children were clustered into two groups : Group A ( lower AOPP levels ) and Group B ( higher AOPP levels ) .
RESULTS	The cluster membership was significantly associated with anaemia ( p = 0.003 ) as well as with the GSR RS3594 polymorphism ( p = 0.037 ) .
RESULTS	Mixed linear regression analyses found that the single nucleotide polymorphisms GCLC RS10948751 and HMOX1 RS17885925 were significantly associated with AOPP levels ( p = 0.030 and p = 0.027 , respectively ) .
CONCLUSIONS	Plasma AOPP levels were predictive for anaemia and oxidative stress markers for clinical malaria infection in two year old children .
CONCLUSIONS	Several polymorphisms in GCLC , GSR and HMOX1 genes were associated with oxidative stress status of these children .

###25644340
BACKGROUND	Whole-grain ( WG ) foods have been suggested to reduce the risk of cardiovascular disease , but studies are inconsistent and effects on cardiovascular risk markers are not clear .
OBJECTIVE	The objective of this study was to assess the impact of increasing WG consumption to at least 80 g/d on overall dietary intake , body composition , blood pressure ( BP ) , blood lipids , blood glucose , gastrointestinal microbiology , and gastrointestinal symptoms in healthy , middle-aged adults with habitual WG intake < 24 g/d .
METHODS	Eligible subjects [ 12 men , 21 women , aged 40-65 y , body mass index ( BMI ) : 20-35 kg/m ( 2 ) ] were identified through use of food frequency questionnaires and subsequently completed 3-day food diaries ( 3DFDs ) to confirm habitual WG consumption .
METHODS	Subjects consumed diets high in WG ( > 80 g/d ) or low in WG [ < 16 g/d , refined-grain ( RG ) diet ] in a crossover study with 6-wk intervention periods separated by a 4-wk washout .
METHODS	Adherence was achieved by specific dietary advice and provision of a range of cereal food products .
METHODS	The 3DFDs , diet compliance diaries , and plasma alkylresorcinols were used to verify compliance .
RESULTS	During the WG intervention , consumption increased from 28 g/d to 168 g/d ( P < 0.001 ) , accompanied by an increase in plasma alkylresorcinols ( P < 0.001 ) and total fiber intake ( P < 0.001 ) , without any effect on energy or other macronutrients .
RESULTS	Although there were no effects on studied variables , there were trends toward increased 24-h fecal weight ( P = 0.08 ) and reduction in body weight ( P = 0.10 ) and BMI ( P = 0.08 ) during the WG intervention compared with the RG period .
CONCLUSIONS	A combination of dietary advice and provision of commercially available food items enabled subjects with a low-moderate habitual consumption of WG to substantially increase their WG intake , but there was little effect on blood biochemical markers , body composition , BP , fecal measurements , or gut microbiology .
CONCLUSIONS	This trial was registered at www.controlled-trials.com as ISRCTN36521837 .

###24423324
BACKGROUND	Biochemical control reduces morbidity and increases life expectancy in patients with acromegaly .
BACKGROUND	With current medical therapies , including the gold standard octreotide long-acting-release ( LAR ) , many patients do not achieve biochemical control .
OBJECTIVE	Our objective was to demonstrate the superiority of pasireotide LAR over octreotide LAR in medically naive patients with acromegaly .
METHODS	We conducted a prospective , randomized , double-blind study at 84 sites in 27 countries .
METHODS	A total of 358 patients with medically naive acromegaly ( GH > 5 g/L or GH nadir 1 g/L after an oral glucose tolerance test ( OGTT ) and IGF-1 above the upper limit of normal ) were enrolled .
METHODS	Patients either had previous pituitary surgery but no medical treatment or were de novo with a visible pituitary adenoma on magnetic resonance imaging .
METHODS	Patients received pasireotide LAR 40 mg/28 days ( n = 176 ) or octreotide LAR 20 mg/28 days ( n = 182 ) for 12 months .
METHODS	At months 3 and 7 , titration to pasireotide LAR 60 mg or octreotide LAR 30 mg was permitted , but not mandatory , if GH 2.5 g/L and/or IGF-1 was above the upper limit of normal .
METHODS	The main outcome measure was the proportion of patients in each treatment arm with biochemical control ( GH < 2.5 g/L and normal IGF-1 ) at month 12 .
RESULTS	Biochemical control was achieved by significantly more pasireotide LAR patients than octreotide LAR patients ( 31.3 % vs 19.2 % ; P = .007 ; 35.8 % vs 20.9 % when including patients with IGF-1 below the lower normal limit ) .
RESULTS	In pasireotide LAR and octreotide LAR patients , respectively , 38.6 % and 23.6 % ( P = .002 ) achieved normal IGF-1 , and 48.3 % and 51.6 % achieved GH < 2.5 g/L .
RESULTS	31.0 % of pasireotide LAR and 22.2 % of octreotide LAR patients who did not achieve biochemical control did not receive the recommended dose increase .
RESULTS	Hyperglycemia-related adverse events were more common with pasireotide LAR ( 57.3 % vs 21.7 % ) .
CONCLUSIONS	Pasireotide LAR demonstrated superior efficacy over octreotide LAR and is a viable new treatment option for acromegaly .

###25948727
OBJECTIVE	We examined whether IV administration of cyclosporine in combination with thrombolysis might reduce cerebral infarct size .
METHODS	Patients aged 18 to 85 years , presenting with an anterior-circulation stroke and eligible for thrombolytic therapy , were enrolled in this multicenter , single-blinded , controlled trial .
METHODS	Fifteen minutes after randomization , patients received either an IV bolus injection of 2.0 mg/kg cyclosporine ( Sandimmune , Novartis ) or placebo .
METHODS	The primary endpoint was infarct volume on MRI at 30 days .
METHODS	Secondary endpoints included infarct volume according to the site ( proximal/distal ) of arterial occlusion and recanalization after thrombolysis .
RESULTS	From October 2009 to July 2013 , 127 patients were enrolled .
RESULTS	The primary endpoint was assessed in 110 of 127 patients .
RESULTS	The reduction of infarct volume in the cyclosporine compared with the control group was overall not significant ( 21.8 mL [ interquartile range , IQR 5.1 , 69.2 mL ] vs 28.8 mL [ IQR 7.7 , 95.0 mL ] , respectively ; p = 0.18 ) .
RESULTS	However , in patients with proximal occlusion and effective recanalization , infarct volume was significantly reduced in the cyclosporine compared with the control group ( 14.9 mL [ IQR 1.3 , 23.2 mL ] vs 48.3 mL [ IQR 34.5 , 118.2 mL ] , respectively ; p = 0.009 ) .
CONCLUSIONS	Cyclosporine was generally not effective in reducing infarct size .
CONCLUSIONS	However , a smaller infarct size was observed in patients with proximal cerebral artery occlusion and efficient recanalization .
METHODS	This study provides Class I evidence that in patients with an acute anterior-circulation stroke , thrombolysis plus IV cyclosporine does not significantly decrease 30-day MRI infarct volume compared with thrombolysis alone .

###24670048
BACKGROUND	Whether listening to background music enhances verbal learning performance is still a matter of dispute .
BACKGROUND	In this study we investigated the influence of vocal and instrumental background music on verbal learning .
METHODS	226 subjects were randomly assigned to one of five groups ( one control group and 4 experimental groups ) .
METHODS	All participants were exposed to a verbal learning task .
METHODS	One group served as control group while the 4 further groups served as experimental groups .
METHODS	The control group learned without background music while the 4 experimental groups were exposed to vocal or instrumental musical pieces during learning with different subjective intensity and valence .
METHODS	Thus , we employed 4 music listening conditions ( vocal music with high intensity : VOC_HIGH , vocal music with low intensity : VOC_LOW , instrumental music with high intensity : INST_HIGH , instrumental music with low intensity : INST_LOW ) and one control condition ( CONT ) during which the subjects learned the word lists .
METHODS	Since it turned out that the high and low intensity groups did not differ in terms of the rated intensity during the main experiment these groups were lumped together .
METHODS	Thus , we worked with 3 groups : one control group and two groups , which were exposed to background music ( vocal and instrumental ) during verbal learning .
METHODS	As dependent variable , the number of learned words was used .
METHODS	Here we measured immediate recall during five learning sessions ( recall 1 - recall 5 ) and delayed recall for 15 minutes ( recall 6 ) and 14 days ( recall 7 ) after the last learning session .
RESULTS	Verbal learning improved during the first 5 recall sessions without any strong difference between the control and experimental groups .
RESULTS	Also the delayed recalls were similar for the three groups .
RESULTS	There was only a trend for attenuated verbal learning for the group passively listened to vocals .
RESULTS	This learning attenuation diminished during the following learning sessions .
CONCLUSIONS	The exposure to vocal or instrumental background music during encoding did not influence verbal learning .
CONCLUSIONS	We suggest that the participants are easily able to cope with this background stimulation by ignoring this information channel in order to focus on the verbal learning task .

###25557347
OBJECTIVE	To determine the relationship between abdominal breathing and tear meniscus volume in healthy women , we investigated the change in tear meniscus volume in two groups : normal breathing and abdominal breathing .
METHODS	We used a crossover experimental model and examined 20 healthy women aged 20-54 years ( mean SD , 32.7 11.1 years ) .
METHODS	The participants were randomly assigned to one of two groups .
METHODS	During the first visit , the normal breathing group was subjected to normal breathing for 3 min , whereas the abdominal breathing group was subjected to abdominal breathing ( 4-second inhalation and 6-second exhalation ) for 3 min .
METHODS	During the second visit , the protocols were swapped between the two groups .
METHODS	We estimated the R wave to R wave ( R-R ) interval , tear meniscus volume , salivary amylase activity , pulse , and blood pressure before and immediately after , 15 min after , and 30 min after completion of the breathing activity .
RESULTS	After abdominal breathing , compared to that before breathing , the tear meniscus volume increased significantly 15 min after breathing ( P < .01 ) .
RESULTS	Furthermore , systolic blood pressure showed a significant decrease immediately after abdominal breathing ( P < 0.05 ) .
RESULTS	No significant difference was found in the test parameters in the normal breathing group .
CONCLUSIONS	Abdominal breathing for 3 minutes increases the tear meniscus volume in healthy women .
CONCLUSIONS	Consequently , abdominal breathing may be considered in the treatment of dry eye disease .

###25384471
BACKGROUND	Healing tissue of the rotator cuff does not regenerate the native enthesis ; fibrovascular scar tissue is formed instead and this has less favourable biomechanical properties .
BACKGROUND	The purpose of this study was to determine if the application of adipose tissue-derived stem cells ( ASCs ) could improve biomechanical and histological properties of the repair .
METHODS	Fifty Sprague-Dawley rats underwent detachment and repair of the supraspinatus tendon , 32 for the biomechanical study and 18 for the histological examination .
METHODS	Animals were randomised in two groups to receive either a collagen carrier alone ( untreated group ) or the carrier plus 210 ( 6 ) ASCs ( ASCs group ) .
METHODS	A control group ( suture only ) was also included for the histological examination .
METHODS	The animals were sacrificed at 2 and 4 weeks for the biomechanical study and at 24 hours , and 1 and 4 weeks for the histological study .
METHODS	Maximum load failure energy , elastic energy , mechanical deformation , stiffness and absorbed energy were measured .
METHODS	Immunofluorescence testing was conducted to show the presence of ASCs in the repair area .
RESULTS	There were no differences between the untreated group and the ASCs group in any of the biomechanical variables at the 2 - and 4-week time points .
RESULTS	The mechanical deformation before failure was higher for the ASCs group compared with the untreated group at 2 weeks and 4 weeks ( p = 0.09 ) , as was the absorbed energy ( p = 0.06 ) .
RESULTS	Differences in maximum load to failure between 2 and 4 weeks were significant for the untreated group ( p = 0.04 ) but not for the ASCs group ( p = 0.17 ) .
RESULTS	Histological examination showed less acute inflammation with diminished presence of oedema and neutrophils in the ASCs group .
RESULTS	There were no differences in the orientation of collagen fibres between groups at either time point .
RESULTS	In the ASCs group , collagen was present only at the last time point .
CONCLUSIONS	The application of ASCs in a rat rotator cuff repair model did not improve the biomechanical properties of the tendon-to-bone healing .
CONCLUSIONS	However , the ASCs group showed less inflammation , which may lead to a more elastic repair and less scarred healing .

###24526542
BACKGROUND	The quality of code status discussions ( CSDs ) is suboptimal as physicians often fail to discuss patients ' goals of care and resuscitation outcomes .
BACKGROUND	We previously demonstrated that internal medicine residents randomized to a communication skills intervention scored higher than controls on a CSD checklist using a standardized patient .
BACKGROUND	However , the impact of this training on CSD content is unknown .
OBJECTIVE	Compare CSD content between intervention and control residents .
METHODS	We conducted qualitative analysis of simulated CSDs .
METHODS	Augmenting a priori codes with constant comparative analysis , we identified key themes associated with resident determination of code status .
METHODS	We dichotomized each theme as present or absent .
METHODS	We used chi-square tests to evaluate the association between training and presence of each theme .
METHODS	Fifty-six residents rotating on the internal medicine service in July 2010 were randomized to intervention ( n = 25 ) or control ( n = 31 ) .
METHODS	Intervention residents completed CSD skills training ( lectures , deliberate practice , and self-study ) .
METHODS	Six months later , all 56 residents completed a simulated CSD .
METHODS	Comparison of key themes identified in CSDs among intervention and controls .
RESULTS	Fifty-one transcripts were recorded and reviewed .
RESULTS	Themes identified included : exploration of patient values/goals , framing code status as a patient decision , discussion of resuscitation outcomes and quality of life , and making a recommendation regarding code status .
RESULTS	Intervention residents were more likely than controls to explore patient values/goals ( p = 0.002 ) and make a recommendation ( p < 0.001 ) ; and less likely to frame the decision as one solely to be made by the patient ( p = 0.01 ) .
RESULTS	Less than one-third of residents discussed resuscitation outcomes or quality of life .
CONCLUSIONS	Training positively influenced CSD content in key domains , including exploration of patient values/goals , making a recommendation regarding code status , and not framing code status as solely a patient decision .
CONCLUSIONS	However , despite the intervention , residents infrequently discussed resuscitation outcomes and quality of life .

###24432969
OBJECTIVE	To determine the relationships among traditional and laparoscopic surgical skills , spatial analysis skills , and video gaming proficiency of third-year veterinary students .
METHODS	Prospective , randomized , controlled study .
METHODS	A convenience sample of 29 third-year veterinary students .
METHODS	The students had completed basic surgical skills training with inanimate objects but had no experience with soft tissue , orthopedic , or laparoscopic surgery ; the spatial analysis test ; or the video games that were used in the study .
METHODS	Scores for traditional surgical , laparoscopic , spatial analysis , and video gaming skills were determined , and associations among these were analyzed by means of Spearman 's rank order correlation coefficient ( rs ) .
RESULTS	A significant positive association ( rs = 0.40 ) was detected between summary scores for video game performance and laparoscopic skills , but not between video game performance and traditional surgical skills scores .
RESULTS	Spatial analysis scores were positively ( rs = 0.30 ) associated with video game performance scores ; however , that result was not significant .
RESULTS	Spatial analysis scores were not significantly associated with laparoscopic surgical skills scores .
RESULTS	Traditional surgical skills scores were not significantly associated with laparoscopic skills or spatial analysis scores .
CONCLUSIONS	Results of this study indicated video game performance of third-year veterinary students was predictive of laparoscopic but not traditional surgical skills , suggesting that laparoscopic performance may be improved with video gaming experience .
CONCLUSIONS	Additional studies would be required to identify methods for improvement of traditional surgical skills .

###24474147
OBJECTIVE	Steroids are used for the treatment of laryngitis in vocal performers and other individuals despite the absence of evidence demonstrating their impact on vocal fold inflammation .
OBJECTIVE	Our objective was to examine laryngeal secretion cytokine inflammatory profile changes associated with corticosteroid treatment in a human phonotrauma model .
METHODS	Prospective , individual , randomized , double-blinded , controlled trial .
METHODS	Participants included 10 healthy females who were randomized to either treatment with oral hydrocortisone or placebo , each given in three doses over 20 hours after the experimental induction of acute phonotrauma .
METHODS	Cytokines associated with inflammation and healing ( interleukin [ IL ] -1 , IL-6 , IL-10 ) were measured in laryngeal secretions before and after vocal loading and at 4 and 20 hours after treatment .
RESULTS	Proinflammatory mediators IL-1 and IL-6 were doubled in the controls versus the steroid treatment group at 21 hours following induction of acute vocal fold inflammation .
RESULTS	Anti-inflammatory cytokine IL-10 showed a 6.3-fold increase in the steroid treatment group versus the controls , indicating anti-inflammatory modulation by steroid treatment .
CONCLUSIONS	This study provides biologic evidence supporting the use of steroids for acute vocal fold inflammation associated with phonotrauma .
METHODS	1b .

###25465417
BACKGROUND	Vorapaxar , a novel antiplatelet therapy , reduces thrombotic events in patients with a history of myocardial infarction ( MI ) or peripheral artery disease ( PAD ) ; however , because of an increased risk of intracranial hemorrhage , it is contraindicated in patients with a history of stroke .
OBJECTIVE	The aim of this study was to investigate the incidence of new ischemic stroke and subsequent death or intracerebral hemorrhage in patients with MI or PAD and no cerebrovascular disease ( CVD ) treated with vorapaxar .
METHODS	The TRA 2 P-TIMI 50 ( Trial to Assess the Effects of Vorapaxar in Preventing Heart Attack and Stroke in Patients With Atherosclerosis-Thrombolysis In Myocardial Infarction 50 ) was a randomized , double-blind , placebo-controlled trial of vorapaxar 2.5 mg daily in 26,449 patients with atherosclerosis , stratified by qualifying disease ( MI , PAD , or CVD ) .
METHODS	A total of 20,170 patients with MI/PAD , but no CVD , were enrolled .
RESULTS	In patients with MI/PAD and no prior stroke or transient ischemic attack , vorapaxar reduced first ischemic stroke ( hazard ratio [ HR ] : 0.57 , 95 % confidence interval [ CI ] : 0.43 to 0.75 ; p < 0.001 ) .
RESULTS	The risk of hemorrhagic conversion after stroke ( HR : 1.19 , 95 % CI : 0.49 to 2.91 ; p = 0.70 ) or death ( HR : 1.09 , 95 % CI : 0.57 to 2.07 ; p = 0.79 ) during follow-up was not significantly increased with vorapaxar in patients who had a new ischemic stroke ( n = 204 ) .
RESULTS	Although hemorrhagic stroke was increased ( HR : 2.79 , 95 % CI : 1.00 to 7.73 ; p = 0.049 ) , overall stroke was significantly reduced ( HR : 0.67 , 95 % CI : 0.52 to 0.87 ; p = 0.002 ) .
CONCLUSIONS	Vorapaxar reduces ischemic stroke in patients with MI or PAD and no known CVD .
CONCLUSIONS	There does not appear to be a significant increase in the risk of hemorrhagic conversion or death in patients who experienced a first ischemic stroke on vorapaxar .
CONCLUSIONS	Although primary hemorrhagic stroke is increased , vorapaxar reduces the total incidence of stroke .
CONCLUSIONS	( Trial to Assess the Effects of Vorapaxar ( SCH 530348 ; MK-5348 ) in Preventing Heart Attack and Stroke in Patients With Atherosclerosis [ TRA 2 P-TIMI 50 ] ; NCT00526474 ) .

###25148829
BACKGROUND	We designed a randomized , controlled prospective study aimed at comparing efficacy and tolerability of ezetimibe + fenofibrate treatment versus pravastatin monotherapy in dyslipidemic HIV-positive ( HIV + ) patients treated with protease inhibitors ( PIs ) .
METHODS	We consecutively enrolled 42 HIV + dyslipidemic patients on stable PIs therapy ( LDL cholesterol > 130 mg/dl or triglycerides 200-500 mg/dl with non-HDL cholesterol > 160 mg/dl ) .
METHODS	After basal evaluation , patients were randomized to a six-month treatment with ezetimibe 10 mg/day + fenofibrate 200 mg/day or with pravastatin 40 mg/day .
METHODS	Both at the basal evaluation and after the six-month treatment , the patients underwent blood tests for lipid parameters , and muscle and liver enzymes .
RESULTS	At baseline , the two groups ( 21 patients each ) were similar with regards to gender , age , BMI , blood pressure and virologic and metabolic parameters .
RESULTS	After the six-month therapy , total cholesterol , LDL cholesterol and non-HDL cholesterol decreased significantly ( p < 0.01 ) in both groups .
RESULTS	high-density lipoprotein ( HDL ) cholesterol increased ( 44 10 to 53 12 mg/dl , p < 0.005 ) and triglycerides decreased ( from 265 118 mg/dl to 149 37 mg/dl , p < 0.001 ) in the ezetimibe + fenofibrate group , whereas both parameters remained unchanged in the pravastatin group .
RESULTS	Mean values of creatine kinase ( CK ) , alanine aminotransferase and aspartate aminotransferase were unchanged in both groups ; only one patient in the pravastatin group stopped the treatment after two months , due to increased CK .
CONCLUSIONS	In dyslipidemic HIV + patients on PI therapy , the association of ezetimibe + fenofibrate is more effective than pravastatin monotherapy in improving lipid profile and is also well tolerated .

###24977688
OBJECTIVE	Modified ultrafiltration is used to ameliorate the deleterious effects of cardiopulmonary bypass in pediatric cardiac surgery patients .
OBJECTIVE	The ideal duration of modified ultrafiltration has not been established yet .
OBJECTIVE	We investigated the effects of extended duration of modified ultrafiltration on pulmonary functions and hemodynamics in the early postoperative period in newborns and infants who had transposition of great arteries operations .
METHODS	Single-center prospective randomized study .
METHODS	Pediatric cardiac surgery operating room and ICU .
METHODS	Sixty newborns and infants who had been scheduled to undergo transposition of great arteries operation .
METHODS	None .
RESULTS	Modified ultrafiltration was applied to all patients following the termination of cardiopulmonary bypass ( for 10 , 15 , and 20 min in groups 1 , 2 , and 3 , respectively ) .
RESULTS	Pulmonary compliance , gas exchange capacity , hemodynamic measurements , inotropic support , blood loss , transfusion requirements , hematocrit level , and duration of ventilatory support were measured after intubation , at termination of cardiopulmonary bypass , at the end of modified ultrafiltration , and in the 1st , 6th , 12th , and 24th hours after admission to ICU .
RESULTS	The amount of fluid removed by modified ultrafiltration in groups 2 and 3 was larger than that of group 1 ( p < 0.01 ) .
RESULTS	Systolic blood pressure was significantly increased at the end of modified ultrafiltration in group 3 compared to groups 1 and 2 ( p < 0.05 ) .
RESULTS	Hematocrit levels were significantly increased at the end of modified ultrafiltration in groups 2 and 3 compared to group 1 ( p < 0.01 ) .
RESULTS	Therefore , RBCs were transfused less after modified ultrafiltration in groups 2 and 3 compared to group 1 ( p < 0.05 ) .
RESULTS	Static and dynamic compliance , oxygen index , and ventilation index had improved similarly in all three groups at the end of modified ultrafiltration ( p > 0.05 ) CONCLUSIONS : : Modified ultrafiltration acutely improved pulmonary compliance and gas exchange in all groups .
RESULTS	Increased hematocrit and blood pressure levels were also observed in the longer modified ultrafiltration group .
RESULTS	However , extended duration of modified ultrafiltration did not have a significant impact on duration of intubation or the stay in ICU .

###24508669
BACKGROUND	18F-Sodium fluoride ( 18F-NaF ) and 18F-fluorodeoxyglucose ( 18F-FDG ) are promising novel biomarkers of disease activity in aortic stenosis .
BACKGROUND	We compared 18F-NaF and 18F-FDG uptake with histological characterization of the aortic valve and assessed whether they predicted disease progression .
RESULTS	Thirty patients with aortic stenosis underwent combined positron emission and computed tomography using 18F-NaF and 18F-FDG radiotracers .
RESULTS	In 12 patients undergoing aortic valve replacement surgery ( 10 for each tracer ) , radiotracer uptake ( mean tissue /
BACKGROUND	= 0.65 ; P = 0.04 ) and osteocalcin ( r = 0.68 ; P = 0.03 ) immunohistochemistry .
BACKGROUND	There was no significant correlation between 18F-FDG uptake and CD68 staining ( r = -0.43 ; P = 0.22 ) .
BACKGROUND	After 1 year , aortic valve calcification increased from 314 ( 193-540 ) to 365 ( 207-934 ) AU ( P < 0.01 ) .
BACKGROUND	Baseline 18F-NaF uptake correlated closely with the change in calcium score ( r = 0.66 ; P < 0.01 ) , and this improved further ( r = 0.75 ; P < 0.01 ) when 18F-NaF uptake overlying computed tomography-defined macrocalcification was excluded .
BACKGROUND	No significant correlation was noted between valvular 18F-FDG uptake and change in calcium score ( r = -0.11 ; P = 0.66 ) .
CONCLUSIONS	18F-NaF uptake identifies active tissue calcification and predicts disease progression in patients with calcific aortic stenosis .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01358513 .

###24938081
BACKGROUND	Major depressive disorder is highly prevalent among Latinos with limited English language proficiency in the United States .
BACKGROUND	Although major depressive disorder is highly treatable , barriers to depression treatment have historically prevented Latinos with limited English language proficiency from accessing effective interventions .
BACKGROUND	The project seeks to evaluate the efficacy of behavioral activation treatment for depression , an empirically supported treatment for depression , as an intervention that may address some of the disparities surrounding the receipt of efficacious mental health care for this population .
METHODS	Following a pilot study of behavioral activation treatment for depression with 10 participants which yielded very promising results , the current study is a randomized control trial testing behavioral activation treatment for depression versus a supportive counseling treatment for depression .
METHODS	We are in the process of recruiting 60 Latinos with limited English language proficiency meeting criteria for major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders 4th and 5th Edition for participation in a single-center efficacy trial .
METHODS	Participants are randomized to receive 10 sessions of behavioral activation treatment for depression ( n = 30 ) or 10 sessions of supportive counseling ( n = 30 ) .
METHODS	Assessments occur prior to each session and at 1 month after completing treatment .
METHODS	Intervention targets include depressive symptomatology and the proposed mechanisms of behavioral activation treatment for depression : activity level and environmental reward .
METHODS	We will also examine other factors related to treatment outcome such as treatment adherence , treatment satisfaction , and therapeutic alliance .
CONCLUSIONS	This randomized controlled trial will allow us to determine the efficacy of behavioral activation treatment for depression in a fast-growing , yet highly underserved population in US mental health services .
CONCLUSIONS	The study is also among the first to examine the effect of the proposed mechanisms of change of behavioral activation treatment for depression ( that is , activity level and environmental reward ) on depression over time .
CONCLUSIONS	To our knowledge , this is the first randomized controlled trial to compare an empirical-supported treatment to a control supportive counseling condition in a sample of depressed , Spanish-speaking Latinos in the United States .
BACKGROUND	Clinical Trials Register : NCT01958840 ; registered 8 October 2013 .

###24508473
BACKGROUND	Effects on the atrial fibrillatory rate ( AFR ) were studied during infusion with the combined potassium and sodium channel blocker AZD7009 .
RESULTS	Patients with persistent atrial fibrillation ( AF ) were randomized to AZD7009 or placebo .
RESULTS	Thirty-five patients converted to sinus rhythm ( SR ) and were matched to 35 non-converters .
RESULTS	The mean AFR before conversion was 231 fibrillations per minute ( fpm ) , having decreased by 41 % ; in non-converters , it was 296 fpm at the end of infusion , having decreased by 26 % .
RESULTS	The rate of decrease was greater in converters at 5 min , -88 vs. -66 fpm ( p = 0.02 ) , and at 10 min , -133 vs. -111 fpm ( p = 0.048 ) .
RESULTS	The AFR-SD and the exponential decay decreased .
RESULTS	A small left atrial area was the only baseline predictor of conversion to SR. .
CONCLUSIONS	AZD7009 produced a significantly more rapid decrease of the AFR in converters than in non-converters , but the AFR at baseline was not predictive of conversion .

###24329972
OBJECTIVE	We examined the cost-effectiveness of extended smoking cessation treatment in older smokers .
METHODS	Participants who completed a 12-week smoking cessation program were factorial randomized to extended cognitive behavioral treatment and extended nicotine replacement therapy .
METHODS	A free-standing smoking cessation clinic .
METHODS	A total of 402 smokers aged 50 years and older were recruited from the community .
METHODS	The trial measured biochemically verified abstinence from cigarettes after 2 years and the quantity of smoking cessation services utilized .
METHODS	Trial findings were combined with literature on changes in smoking status and the age - and gender-adjusted effect of smoking on health-care cost , mortality and quality of life over the long term in a Markov model of cost-effectiveness over a lifetime horizon .
RESULTS	The addition of extended cognitive behavioral therapy added $ 83 in smoking cessation services cost [ P = 0.012 , confidence interval ( CI ) = $ 22-212 ] .
RESULTS	At the end of follow-up , cigarette abstinence rates were 50.0 % with extended cognitive behavioral therapy and 37.2 % without this therapy ( P < 0.05 , odds ratio 1.69 , CI 1.18-2 .54 ) .
RESULTS	The model-based incremental cost-effectiveness ratio was $ 6324 per quality-adjusted life year ( QALY ) .
RESULTS	Probabilistic sensitivity analysis found that the additional $ 947 in lifetime cost of the intervention had a 95 % confidence interval of - $ 331 to 2081 ; the 0.15 additional QALYs had a confidence interval of 0.035-0 .280 , and that the intervention was cost-effective against a $ 50000/QALY acceptance criterion in 99.6 % of the replicates .
RESULTS	Extended nicotine replacement therapy was not cost-effective .
CONCLUSIONS	Adding extended cognitive behavior therapy to standard cessation treatment was cost-effective .
CONCLUSIONS	Further intensification of treatment may be warranted .

###24309200
BACKGROUND	The diagnosis of childhood pulmonary tuberculosis remains a challenge .
BACKGROUND	The effectiveness of the Keith Edwards scoring system used to diagnose tuberculosis is controversial .
BACKGROUND	We evaluated this scoring system in the present study .
METHODS	A prospective randomized study was conducted between March 2008 and December 2011 at the Kimpese General Evangelical Hospital in the Democratic Republic of Congo .
METHODS	The results of the Keith Edwards score were considered for the 161 children ( 100 pulmonary tuberculosis and 61 case controls ) who were enrolled in the study .
METHODS	The association between different parameters and the score and between these parameters and pulmonary tuberculosis were statistically analyzed using univariate and multivariate tests .
RESULTS	Eighty-five ( 85 % ) out of the 100 children diagnosed as having pulmonary tuberculosis and 20 ( 32.8 % ) of the case controls had a positive score .
RESULTS	The age of the patient , duration of the disease , nutritional status , tuberculosis contact , positive tuberculin skin test , and lymph node enlargement showed a significant statistical association with the score and pulmonary tuberculosis ( P < 0.05 ) .
RESULTS	The score 's sensitivity and specificity were 85 % and 67.2 % , respectively .
RESULTS	The positive predictive value and negative predictive value were found to be 80.9 % and 73.2 % , respectively .
RESULTS	The positive likelihood ratio was 2.57 , the negative likelihood ratio was 0.22 , and overall agreement was 76.1 % .
CONCLUSIONS	The Keith Edwards score could be good tool for public health purposes , but it might be less effective for individual diagnosis of childhood pulmonary tuberculosis because of low specificity .
CONCLUSIONS	Further studies are required to evaluate and validate the diagnostic value of clinical and radiological symptoms in childhood pulmonary tuberculosis .

###24651746
OBJECTIVE	To assess lesion detection and diagnostic confidence of computed tomography ( CT ) of the chest performed at less than 1 mSv with 2 iterative reconstruction ( IR ) techniques .
METHODS	Ten patients gave written informed consent for the acquisitions of images at submillisievert dose ( 0.9 mSv ) , in addition to clinical standard-dose ( SD ) chest CT ( 2.9 mSv ) .
METHODS	Submillisievert images were reconstructed with iDose and iterative model reconstruction ( IMR ) .
METHODS	Two radiologists assessed lesion detection , margins , diagnostic confidence , and visibility of small structures .
METHODS	Objective noise and noise spectral density were measured .
RESULTS	Lesion detection was identical for standard-dose filtered back projection ( FBP ) , submSv iDose , and submSv IMR .
RESULTS	Lesion margins were better seen for 30 % of detected lung lesions with submSv IMR compared to standard-dose FBP and submSv iDose ( P < 0.05 ) .
RESULTS	Visibility of abdominal structures , and diagnostic confidence with submSv iDose and submSv IMR were similar to standard-dose FBP .
RESULTS	There was 21 % to 64 % noise reduction with submSv IMR and 1 % to 15 % higher noise with iDose compared to standard-dose FBP ( P < 0.0001 ) .
CONCLUSIONS	Submillisievert IMR improves delineation of lesion margins compared to standard-dose FBP and submSv iDose .

###25134001
OBJECTIVE	The effects of glucose-and-fructose ( GF ) coingestion on cycling time trial ( TT ) performance and physiological responses to exercise were examined under postprandial conditions .
METHODS	Eight trained male cyclists ( age , 25 6 yr ; height , 180 4 cm ; weight , 77 9 kg ; VO2max , 62 6 mLkgmin ) completed the study .
METHODS	Subjects ingested either an artificially sweetened placebo ( PL ) , a moderate-glucose beverage ( MG , 1.03 gmin ) , a high-glucose beverage ( HG , 1.55 gmin ) , or a GF beverage ( 1.55 gmin , 2:1 ratio ) during approximately 3 h of exercise , including 2 h of constant-load cycling ( 55 % Wmax , 195 17 W ) , immediately followed by a computer-simulated 30-km TT .
METHODS	Physiological responses ( VE , VO2 , RER , HR , blood glucose level , blood lactate level , and RPE ) and incidences of gastrointestinal distress were assessed during early ( 15-20 min ) , middle ( 55-60 min ) , and late exercise ( 115-120 min ) and during the TT .
METHODS	Magnitude-based qualitative inferences were used to evaluate differences between treatments .
RESULTS	In comparison with that in PL ( 52.9 3.7 min ) , TT performances were faster with GF ( 50.4 2.2 min , `` very likely '' benefit ) , MG ( 51.1 2.4 min , `` likely '' benefit ) , and HG ( 52.0 3.7 min , `` possible '' benefit ) .
RESULTS	GF resulted in a `` likely '' improvement versus HG ( 3.0 % ) and an `` unclear '' effect relative to MG ( 1.2 % ) .
RESULTS	MG was `` possibly '' beneficial versus HG ( 1.8 % ) .
RESULTS	Few incidences of GI distress were reported in any trials .
CONCLUSIONS	GF ingestion seems to enhance performance , relative to PL and HG .
CONCLUSIONS	However , it is unclear whether GF improves performance versus moderate doses of glucose .

###24673051
OBJECTIVE	To observe the impacts of the acupoint catgut implantation on postpartum pain of uterine contraction with qi and blood deficiency .
METHODS	One hundred and ten primiparas of natural delivery differentiated as qi and blood deficiency pattern in TCM were selected as the subjects .
METHODS	They were randomized into an acupoint catgut implantation group ( 55 cases ) and a routine nursing group ( 55 cases ) .
METHODS	In the acupoint catgut implantation group , the catgut was implanted in Zigong ( EX-CA 1 ) , Zusanli ( ST 36 ) , Sanyinjiao ( SP 6 ) , Pishu ( BL 20 ) and Geshu ( BL 17 ) in 6 h after delivery ; additionally , the routine post-delivery nursing was adopted .
METHODS	In the routine nursing group , the routine post-delivery nursing was applied simply .
METHODS	Visual analogue scale ( VAS ) and the pain relief time of uterine contraction were compared in 24 h , 48 h , 72 h and 96 h after acupoint catgut implantation between the two groups .
RESULTS	VAS Scores in 24 h , 48 h , 72 h and 96 h after acupoint catgut implantation in the acupoint catgut implantation group were lower apparently than those in the routine nursing group ( 3.31 + / - 0.39 vs 4.31 + / - 0.29 , 1.86 + / - 0.29 vs 2.66 + / - 0.25 , 0.89 + / - 0.21 vs 1.59 + / - 0.24 , 0.35 + / - 0.10 vs 0.69 + / - 0.13 , all P < 0.05 ) .
RESULTS	The pain relief was achieved in ( 72.06 + / - 6.83 ) h in the acupoint catgut implantation group and was ( 123.42 + / - 11.12 ) h in the routine nursing group .
RESULTS	The pain relief in the acupoint catgut implantation group was achieved more quickly ( P < 0.01 ) .
CONCLUSIONS	The intervention of acupoint catgut implantation in 6 h after natural delivery in primiparas prevents effectively postpartum pain of uterine contraction .

###26218726
BACKGROUND	The cosmetic appearance of a facial scar is a concern for patients undergoing Mohs micrographic surgery ( MMS ) .
BACKGROUND	Although suturing technique may influence scar cosmesis , few studies have been published comparing suturing methods for MMS repair .
OBJECTIVE	To compare the cosmetic appearance of facial MMS scars sutured with either continuous or interrupted percutaneous nylon sutures .
METHODS	Patients with facial MMS defects were randomized to have half their scar sutured with interrupted 5-0 nylon stitches , whereas the other half of the scar was closed with running 5-0 nylon stitches .
METHODS	The appearance of each half of the scar was assessed at 1 week , 8 weeks , and 6 months by the principal investigator .
METHODS	Blinded photographic evaluation at 1 week and 6 months was completed by a plastic surgeon and general dermatologist .
RESULTS	A total of 105 patients were entered into the trial , and 101 completed all time point assessments .
RESULTS	There was no statistically significant difference in scar outcome using each of the 3 scar assessment scales , at any time point , for any assessor ( blinded and nonblinded ) .
CONCLUSIONS	Interrupted and continuous 5-0 nylon sutures result in an equivalent final cosmetic appearance of facial MMS scars .
CONCLUSIONS	Given its advantages , running sutures may be the preferred closure technique for facial repair .

###24638238
BACKGROUND	The German Society of Radiation Oncology initiated a multicenter trial to evaluate core processes and subprocesses of radiotherapy by prospective evaluation of all important procedures in the most frequent malignancies treated by radiation therapy .
BACKGROUND	The aim of this analysis was to assess the required resources for interstitial high-dose-rate ( HDR ) and low-dose-rate ( LDR ) prostate brachytherapy ( BRT ) based on actual time measurements regarding allocation of personnel and room occupation needed for specific procedures .
METHODS	Two radiotherapy centers ( community hospital of Offenbach am Main and community hospital of Eschweiler ) participated in this prospective study .
METHODS	Working time of the different occupational groups and room occupancies for the workflow of prostate BRT were recorded and methodically assessed during a 3-month period .
RESULTS	For HDR and LDR BRT , a total of 560 and 92 measurements , respectively , were documented .
RESULTS	The time needed for treatment preplanning was median 24min for HDR ( n = 112 measurements ) and 6min for LDR BRT ( n = 21 ) .
RESULTS	Catheter implantation with intraoperative HDR real-time planning ( n = 112 ) , postimplantation HDR treatment planning ( n = 112 ) , and remotely controlled HDR afterloading irradiation ( n = 112 ) required median 25 , 39 , and 50min , respectively .
RESULTS	For LDR real-time planning ( n = 39 ) and LDR treatment postplanning ( n = 32 ) , the assessed median duration was 91 and 11min , respectively .
RESULTS	Room occupancy and overall mean medical staff times were 194 and 910min respectively , for HDR , and 113 and 371min , respectively , for LDR BRT .
CONCLUSIONS	In this prospective analysis , the resource requirements for the application of HDR and LDR BRT of prostate cancer were assessed methodically and are presented for first time .

###25661296
OBJECTIVE	Management of ureteral stones remains controversial .
OBJECTIVE	To determine whether optimizing the extracorporeal shock wave lithotripsy delivery rate would improve the treatment of solitary ureteral stones we compared the outcomes of 2 delivery rates in a prospective randomized trial .
METHODS	From July 2010 to October 2012 , 254 consecutive patients were randomized to extracorporeal shock wave lithotripsy at a shock wave delivery rate of 60 and 90 pulses per minute in 130 and 124 , respectively .
METHODS	The primary study end point was the stone-free rate at 3-month followup .
METHODS	Secondary end points were stone disintegration , treatment time , complications and the rate of secondary treatments .
METHODS	Descriptive statistics were used to compare end points between the 2 groups .
METHODS	The adjusted OR and 95 % CI were calculated to assess predictors of success .
RESULTS	The stone-free rate at 3 months was significantly higher in patients who underwent extracorporeal shock wave lithotripsy at a shock wave delivery rate of 90 pulses per minute than in those who received 60 pulses per minute ( 91 % vs 80 % , p = 0.01 ) .
RESULTS	Patients with proximal ( 100 % vs 83 % , p = 0.005 ) and mid ureteral stones ( 96 % vs 73 % , p = 0.03 ) accounted for the observed difference but not those with distal ureteral stones ( 81 % vs 80 % , p = 0.9 , respectively ) .
RESULTS	Treatment time , complications and the rate of secondary treatments were comparable between the 2 groups .
RESULTS	On multivariable analysis the shock wave delivery rate of 90 pulses per minute , proximal stone location , stone density , stone size and an absent indwelling Double-J stent were independent predictors of success .
CONCLUSIONS	Optimizing the extracorporeal shock wave lithotripsy delivery rate can achieve excellent results for ureteral stones .

###24285576
OBJECTIVE	To examine penile vibratory stimulation ( PVS ) in the treatment of post-prostatectomy urinary incontinence ( UI ) .
METHODS	Patients with post-prostatectomy UI were included in a 12-week trial .
METHODS	A 24-hr pad test and a 72-hr voiding diary were collected at baseline .
METHODS	Participants were randomized to receive PVS for the first 6 weeks ( group 1 ) or for the final 6 weeks ( group 2 ) of the study .
METHODS	The primary outcome was the difference in leakage between groups 1 and 2 at 6 weeks as measured by changes in the pad test .
METHODS	The trial was registered at www.clinicaltrials.org ( NCT01540656 ) .
RESULTS	Data from 31 men were available for analyses .
RESULTS	The difference in the change on the pad test between the groups did not reach statistical significance at 6 weeks ( P = 0.13 ) while the change in incontinence episodes between groups approached statistical significance ( P = 0.052 ) .
RESULTS	However , there was a median reduction of -33 g ( P = 0.021 ) on the pad test and a median reduction in daily incontinence episodes of -1 ( P = 0.023 ) in group 1 at 6 weeks .
RESULTS	At 12 weeks , group 2 had a median decrease on the pad test of -8 g ( P = 0.10 ) and no change in incontinence episodes .
RESULTS	A pooled analysis showed a decline on the pad test of -13.5 g ( P = 0.004 ) after PVS .
RESULTS	Small improvements were seen in subjective symptom scores and 58 % stated to be satisfied with PVS .
RESULTS	Self-limiting side effects were experienced by 15 % of patients .
CONCLUSIONS	PVS is feasible in the treatment of post-prostatectomy UI .
CONCLUSIONS	Larger trials are needed to document the clinical efficacy .

###24502880
BACKGROUND	No five-year long-term follow-up data is available regarding the prognostic value of GDF-15 .
BACKGROUND	Our aim is to evaluate the long-term prognostic value of admission growth-differentiation factor 15 ( GDF-15 ) regarding death or myocardial infarction ( MI ) in patients with non-ST-elevation acute coronary syndrome ( NSTE-ACS ) .
METHODS	This is a subanalysis from the ICTUS ( Invasive versus Conservative Treatment in Unstable coronary Syndromes ) trial , including troponin positive NSTE-ACS patients .
METHODS	The main outcome for the current analysis was 5-year death or spontaneous MI .
METHODS	GDF-15 samples were available in 1151 patients .
METHODS	The prognostic value of GDF-15 , categorized into < 1200 ng/L , 1200-1800 ng/L and > 1800 ng/L , was assessed in unadjusted and adjusted Cox regression models .
METHODS	Adjustments were made for identified univariable risk factors .
METHODS	The additional discriminative and reclassification value of GDF-15 beyond the independent risk factors was assessed by the category-free net reclassification improvement ( 1/2 NRI ( > 0 ) ) and the integrated discrimination improvement ( IDI ) RESULTS : Compared to GDF-15 < 1200 ng/L , a GDF-15 > 1800 ng/L was associated with an increased hazard ratio for death or spontaneous MI , mainly driven by mortality .
METHODS	GDF-15 levels were predictive after adjustments for other identified predictors .
METHODS	Additional discriminative value was shown with the IDI , not with the NRI .
CONCLUSIONS	In patients presenting with NSTE-ACS and elevated troponin T , GDF-15 provides prognostic information in addition to identified predictors for mortality and spontaneous MI and can be used to identify patients at high risk during long-term follow-up .

###26115560
BACKGROUND	Dietary patterns that are considered healthy ( eg , the Dietary Approaches to Stop Hypertension diet and Mediterranean diet ) may be more successful in reducing typical cardiovascular disease risks compared to dietary patterns considered unhealthy ( eg , energy-dense diets such as the typical American diet ) .
OBJECTIVE	This study assessed the effects of a Korean diet , the 2010 Dietary Guidelines for Americans ( DGA ) , and a typical American diet on cardiometabolic risk factors , including lipid levels and blood pressure , in overweight , non-Asian individuals in the United States with elevated low-density lipoprotein cholesterol .
METHODS	The study was a three-period crossover , controlled-feeding study from January 2012 to May 2012 .
METHODS	Thirty-one subjects were randomly allocated to one of six possible sequential orders for consuming the three diets for 4 weeks , each separated by a 10-day break .
METHODS	Data analysis included 27 subjects on the Korean diet periods and 29 in the DGA and typical American diet periods .
METHODS	Subjects remained weight stable .
METHODS	Lipid profile , blood pressure , insulin , glucose , and 24-hour urinary sodium were determined at baseline and at the end of each diet period .
METHODS	The additive main effects multiplicative interactions model was used to test for a subject by diet interaction .
METHODS	Differences among diets were determined using a mixed-models procedure ( PROC MIXED ) with random intercept for each subject .
RESULTS	Total cholesterol and low-density lipoprotein cholesterol significantly decreased on Korean ( P < 0.0001 and P < 0.01 , respectively ) and DGA ( P < 0.01 and P < 0.05 , respectively ) diets , but not on the typical American diet .
RESULTS	Although an unfavorable outcome , high-density lipoprotein cholesterol significantly decreased on all three diets ( Korean : P < 0.0001 ; DGA : P < 0.0001 ; typical American : P < 0.05 ) .
RESULTS	No diet had a significant effect on serum triglycerides , but a slight increase in triglycerides in the Korean and decrease in the DGA resulted in a significant difference between these two diets ( P < 0.01 ) .
RESULTS	All three diets caused modest decreases in systolic and diastolic blood pressure , which reached statistical significance for DGA only ( P < 0.05 and P < 0.01 , respectively ) .
RESULTS	No diet had significant effect on fasting insulin , whereas fasting glucose decreased significantly on the Korean ( P < 0.01 ) and typical American ( P < 0.05 ) diets only .
RESULTS	Urinary sodium output decreased significantly on DGA ( P < 0.0001 ) .
CONCLUSIONS	After a 4-week feeding period , Korean and DGA diet patterns resulted in positive changes in cardiovascular disease risk factors .

###25453457
BACKGROUND	The primary outcome results for the SPS3 trial suggested that a lower systolic target blood pressure ( < 130 mm Hg ) might be beneficial for reducing the risk of recurrent stroke compared with a higher target ( 130-149 mm Hg ) , but that the addition of clopidogrel to aspirin was not beneficial compared with aspirin plus placebo .
BACKGROUND	In this prespecified secondary outcome analysis of the SPS3 trial , we aimed to assess whether blood pressure reduction and dual antiplatelet treatment affect changes in cognitive function over time in patients with cerebral small vessel disease .
METHODS	In the SPS3 trial , patients with recent ( within 6 months ) symptomatic lacunar infarcts from 81 centres in North America , Latin America , and Spain were randomly assigned , in a two-by-two factorial design , to target levels of systolic blood pressure ( 1:1 ; 130-149 mm Hg vs < 130 mm Hg ; open-label ) and to a once-daily antiplatelet treatment ( 1:1 ; aspirin 325 mg plus clopidogrel 75 mg vs aspirin 325 mg plus placebo ; double-blind ) .
METHODS	For this analysis , the main cognitive outcome was change in Cognitive Abilities Screening Instrument ( CASI ) during follow-up .
METHODS	Patients were tested annually for up to 5 years , during which time the mean difference in systolic blood pressure was 11 mm Hg ( SD 16 ) between the two targets ( 138 mm Hg vs 127 mm Hg at 1 year ) .
METHODS	We used linear mixed models to compare changes in CASI Z scores over time .
METHODS	The SPS3 trial is registered with ClinicalTrials.gov , number NCT00059306 .
RESULTS	The study took place between March 23 , 2003 , and April 30 , 2012.2916 of 3020 SPS3 participants ( mean age 63 years [ SD 11 ] ) with CASI scores at study entry were included in the analysis , with a median follow-up of 30 years ( IQR 10-49 ) .
RESULTS	Mean changes in CASI Z scores from study entry to assessment at years 1 ( n = 2472 ) , 2 ( n = 1968 ) , 3 ( n = 1521 ) , 4 ( n = 1135 ) , and 5 ( n = 803 ) were 012 ( SD 083 ) , 015 ( 084 ) , 016 ( 095 ) , 019 ( 099 ) , and 014 ( 109 ) , respectively .
RESULTS	Changes in CASI Z scores over time did not differ between assigned antiplatelet groups ( p = 0858 ) or between assigned blood pressure target groups ( p = 0520 ) .
RESULTS	There was no interaction between assigned antiplatelet groups and assigned blood pressure target groups and change over time ( p = 0196 ) .
CONCLUSIONS	Cognitive function is not affected by short-term dual antiplatelet treatment or blood pressure reduction in fairly young patients with recent lacunar stroke .
CONCLUSIONS	Future studies of cognitive function after stroke should be of longer duration or focus on patients with higher rates of cognitive decline .
BACKGROUND	US National Institute of Neurological Disorders and Stroke .

###26124351
BACKGROUND	Vascular endothelial growth factor C ( VEGFC ) and vascular endothelial growth factor receptor 1 ( VEGFR1 ) mRNA overexpression has recently been shown to have strong predictive and prognostic value in patients with high-risk early breast cancer undergoing adjuvant chemotherapy .
BACKGROUND	The present study evaluated associations of VEGFC and VEGFR1 with human epidermal growth factor receptor 2 ( HER2 ) and their prognostic value dependent on HER2 status .
METHODS	RNA was isolated from 298 formalin-fixed paraffin-embedded tumor tissue samples from the HeCOG 10/97 ( HE10/97 ) trial , evaluating adjuvant dose-dense sequential chemotherapy with epirubicin followed by cyclophosphamide , methotrexate and 5-fluorouracil therapy with or without paclitaxel ( E-T-CMF vs. E-CMF ) .
METHODS	A fully-automated method based on magnetic beads was applied for RNA extraction , followed by one-step quantitative reverse transcription-polymerase chain reaction .
RESULTS	At 13.3 years of median follow-up , 116 patients ( 38.9 % ) had experienced relapse and 115 ( 38.6 % ) had died .
RESULTS	There were strong associations between VEGFC/VEGFR1 mRNA expression and HER2 and estrogen receptor/progesterone receptor status .
RESULTS	In multivariate analysis , both VEGFC and VEGFR1 were found to be associated with risk for death or relapse , but such associations depended on HER2 status and treatment group .
RESULTS	High VEGFC was a negative prognostic factor for disease-free survival [ hazard ratio ( HR ) = 1.79 , 95 % confidence interval ( CI ) = 1.05-3 .05 , Wald 's p = 0.032 ] , with a trend for overall survival ( HR = 1.80 , 95 % CI = 0.94-3 .47 , p = 0.078 ) in patients treated with E-CMF adjusted for clinicopathological characteristics , while high VEGFR1 was associated with increased risk for death , yet non significantly in patients with HER2-negative disease ( HR = 1.51 , 95 % CI = 0.82-2 .77 , p = 0.18 ) , regardless of treatment .
CONCLUSIONS	VEGFC and VEGFR1 mRNA overexpression is of prognostic value , dependent on HER2 status , in patients with high-risk early breast cancer undergoing adjuvant treatment .
CONCLUSIONS	Among HER2-negative cases , these angiogenic markers could identify more aggressive tumors with worse prognosis .
CONCLUSIONS	Further studies are warranted to validate VEGFC and VEGFR1 as potential biomarkers in adjuvant therapy and their use in identifying sub-groups that could benefit from anti-VEGF strategies .

###25269764
METHODS	Randomized clinical study .
OBJECTIVE	To compare the effects of trigger point ( TrP ) dry needling ( DN ) and TrP manual therapy ( MT ) on pain , function , pressure pain sensitivity , and cervical range of motion in subjects with chronic mechanical neck pain .
BACKGROUND	Recent evidence suggests that TrP DN could be effective in the treatment of neck pain .
BACKGROUND	However , no studies have directly compared the outcomes of TrP DN and TrP MT in this population .
METHODS	Ninety-four patients ( mean SD age , 31 3 years ; 66 % female ) were randomized into a TrP DN group ( n = 47 ) or a TrP MT group ( n = 47 ) .
METHODS	Neck pain intensity ( 11-point numeric pain rating scale ) , cervical range of motion , and pressure pain thresholds ( PPTs ) over the spinous process of C7 were measured at baseline , postintervention , and at follow-ups of 1 week and 2 weeks after treatment .
METHODS	The Spanish version of the Northwick Park Neck Pain Questionnaire was used to measure disability/function at baseline and the 2-week follow-up .
METHODS	Mixed-model , repeated-measures analyses of variance ( ANOVAs ) were used to determine if a time-by-group interaction existed on the effects of the treatment on each outcome variable , with time as the within-subject variable and group as the between-subject variable .
RESULTS	The ANOVA revealed that participants who received TrP DN had outcomes similar to those who received TrP MT in terms of pain , function , and cervical range of motion .
RESULTS	The 4-by-2 mixed-model ANOVA also revealed a significant time-by-group interaction ( P < .001 ) for PPT : patients who received TrP DN experienced a greater increase in PPT ( decreased pressure sensitivity ) than those who received TrP MT at all follow-up periods ( between-group differences : posttreatment , 59.0 kPa ; 95 % confidence interval [ CI ] : 40.0 , 69.2 ; 1-week follow-up , 69.2 kPa ; 95 % CI : 49.5 , 79.1 ; 2-week follow-up , 78.9 kPa ; 95 % CI : 49.5 , 89.0 ) .
CONCLUSIONS	The results of this clinical trial suggest that 2 sessions of TrP DN and TrP MT resulted in similar outcomes in terms of pain , disability , and cervical range of motion .
CONCLUSIONS	Those in the TrP DN group experienced greater improvements in PPT over the cervical spine .
CONCLUSIONS	Future trials are needed to examine the effects of TrP DN and TrP MT over long-term follow-up periods .
METHODS	Therapy , level 1b .

###24649525
OBJECTIVE	To investigate the application of lactic acid in early diagnosis and goal-directed therapy of septic shock , and to provide reference for the early clinical diagnosis and treatment of septic shock .
METHODS	A prospective observational study was conducted , in which patients satisfied with the criteria of septic shock diagnosis were enrolled .
METHODS	The patients were randomly divided into two groups .
METHODS	The lactic group was defined using blood lactic acid concentration < 2 mmol/L as treatment guide target .
METHODS	Control group was defined according to the traditional diagnostic criteria of shock which systolic blood pressure was less than 90 mmHg ( 1 mmHg = 0.133 kPa ) or systolic blood pressure value fell > 40 mmHg baseline or oliguria ( < 0.5 ml .
METHODS	kg-1 .
METHODS	h-1 ) et al traditional septic shock diagnosis criteria and bundle treatment was performed .
METHODS	Organ dysfunction index , the sequential organ failure score ( SOFA ) , acute physiology and chronic health evaluation score II ( APACHE II ) score , the time of mechanical ventilation , the time of stay in the intensive care unit ( ICU ) , and the 7-and 28-day mortality were recorded .
RESULTS	There were 26 and 31 septic shock patients in lactic group and control group respectively .
RESULTS	Organ dysfunction index had been improved in different degrees after treatment compared with that before treatment .
RESULTS	Creatinine ( Cr ) at 48 hours after treatment in lactic group was significantly lower than that in control group ( mol/L : 94.48 6.68 vs. 107.44 10.35 , P < 0.05 ) , and there was no statistical difference in other indexes .
RESULTS	The SOFA score of lactic group at 24 hours and 48 hours after treatment was lower than that of control group ( 9.27 4.62 vs. 9.79 3.80 , t = 2.103 , P = 0.040 ; 8.54 5.53 vs. 9.70 4.30 , t = 2.302 , P = 0.023 ) .
RESULTS	APACHE II score of two group after treatment were lower than that before treatment , and lactic group decreased more obviously compared with control group ( 14.25 5.29 vs. 20.00 9.74 , t = 2.298 , P = 0.026 ; 13.60 6.18 vs 18.15 6.62 , t = 2.653 , P = 0.011 ) .
RESULTS	The time of stay in the ICU and the time of mechanical ventilation of lactic group were shorter that those of control group , but there was no statistical difference [ ICU time ( days ) : 8.95 5.19 vs. 9.45 6.18 , t = 0.605 , P = 0.652 ; mechanical ventilation time ( hours ) : 101.15 11.50 vs. 110.63 13.26 , t = 0.631 , P = 0.564 ] .
RESULTS	There was no statistical difference regarding 7-day mortality of lactic group was lower than that of control group [ 15.38 % ( 4/26 ) vs. 16.13 % ( 5/31 ) , 2 = 0.000 , P = 1.000 ] .
RESULTS	The 28-day mortality of lactic group was lower than that of control group [ 26.92 % ( 7/26 ) vs. 54.84 % ( 17/31 ) .
RESULTS	2 = 4.520 , P = 0.033 ] .
CONCLUSIONS	By blood lactic acid monitoring , inadequacy of organization perfusion i.e. septic shock can be found in the early stage , thus early intervention can be performed and improve resuscitation result and reduce the mortality of septic shock patients .
CONCLUSIONS	Blood lactic acid 4 mmol/L can be used as one of the criteria for the diagnosis of septic shock , and 6-hour blood lactic acid < 2 mmol/L as a goal to guide shock treatment with obvious prognosis improvement .

###25050903
BACKGROUND	The aim of the present trial on ultrasound ( US ) - guided laser ablation therapy ( LAT ) of solid thyroid nodules is to assess long-term clinical efficacy , side effects , and predictability of outcomes in different centers operating with the same procedure .
METHODS	Two hundred consecutive patients were randomly assigned to a single LAT session ( group 1 , 101 cases ) or to follow-up ( group 2 , 99 cases ) at four thyroid referral centers .
METHODS	Entry criteria were : solid thyroid nodule with volume of 6-17 mL , repeat benign cytological findings , normal thyroid function , no autoimmunity , and no thyroid gland treatment .
METHODS	Group 1 : LAT was performed in a single session with two optical fibers , a 1064 nm Nd-YAG laser source , and an output power of 3 W. Volume and local symptom changes were evaluated 1 , 6 , 12 , 24 , and 36 months after LAT .
METHODS	Side effects and tolerability of treatment were registered .
METHODS	Group 2 : Follow-up with no treatment .
RESULTS	One patient was lost to follow-up in each group .
RESULTS	Group 1 : Volume decrease after LAT was -49 22 % , -59 22 % , -60 24 % , and -57 25 % at 6 , 12 , 24 , and 36 months , respectively ( P < .001 vs baseline ) .
RESULTS	LAT resulted in a nodule reduction of > 50 % in 67.3 % of cases ( P < .001 ) .
RESULTS	Local symptoms decreased from 38 to 8 % of cases ( P = .002 ) and cosmetic signs from 72 to 16 % of cases ( P = .001 ) .
RESULTS	Baseline size , presence of goiter ( P = .55 ) , or US findings ( fluid component 20 % [ P = .84 ] , halo [ P = .46 ] , vascularization [ P = .98 ] , and calcifications [ P = .06 ] ) were not predictive factors of a volume decrease > 50 % .
RESULTS	The procedure was well tolerated in most ( 92 % ) cases .
RESULTS	No changes in thyroid function or autoimmunity were observed .
RESULTS	In group 2 , nodule volume increased at 36 months ( 25 42 % ; P = .04 ) .
RESULTS	The efficacy and tolerability of the procedure were similar in different centers .
CONCLUSIONS	A single LAT treatment of solid nodules results in significant and persistent volume reduction and local symptom improvement , in the absence of thyroid function changes .

###24533064
BACKGROUND	Live attenuated influenza vaccines ( LAIVs ) are being developed to protect humans against future epidemics and pandemics .
BACKGROUND	This study describes the results of a double-blinded randomized placebo-controlled phase I clinical trial of cold-adapted and temperature sensitive H7N3 live attenuated influenza vaccine candidate in healthy seronegative adults .
OBJECTIVE	The goal of the study was to evaluate the safety , tolerability , immunogenicity and potential shedding and transmission of H7N3 LAIV against H7 avian influenza virus of pandemic potential .
RESULTS	Two doses of H7N3 LAIV or placebo were administered to 40 randomly divided subjects ( 30 received vaccine and 10 placebo ) .
RESULTS	The presence of influenza A virus RNA in nasal swabs was detected in 60.0 % and 51.7 % of subjects after the first and second vaccination , respectively .
RESULTS	In addition , vaccine virus was not detected among placebo recipients demonstrating the absence of person-to-person transmission .
RESULTS	The H7N3 live attenuated influenza vaccine demonstrated a good safety profile and was well tolerated .
RESULTS	The two-dose immunization resulted in measurable serum and local antibody production and in generation of antigen-specific CD4 and CD8 memory T cells .
RESULTS	Composite analysis of the immune response which included hemagglutinin inhibition assay , microneutralization tests , and measures of IgG and IgA and virus-specific T cells showed that the majority ( 86.2 % ) of vaccine recipients developed serum and/or local antibodies responses and generated CD4 and CD8 memory T cells .
CONCLUSIONS	The H7N3 LAIV was safe and well tolerated , immunogenic in healthy seronegative adults and elicited production of antibodies broadly reactive against the newly emerged H7N9 avian influenza virus .
BACKGROUND	ClinicalTrials.gov NCT01511419 .

###24304938
BACKGROUND	Galectin-3 ( Gal-3 ) is a marker of myocardial fibrosis , and elevated levels are associated with adverse outcomes .
BACKGROUND	Mineralocorticoid receptor antagonists ( MRAs ) modulate cardiac fibrosis in heart failure ( HF ) patients and have been shown to improve long-term outcomes .
BACKGROUND	We examined whether treatment effects from MRA use differed by Gal-3 levels in ambulatory heart failure patients enrolled in HF-ACTION .
RESULTS	HF-ACTION was a randomized controlled trial of exercise training versus usual care in patients with HF due to LV systolic dysfunction ( New York Heart Association functional class II-IV , left ventricular ejection fraction 0.35 , median follow-up 2.5 years ) .
RESULTS	Galectin-3 was assessed at baseline in 895 patients .
RESULTS	The end point was all-cause mortality or all-cause hospitalization ( ACM+ACH ) ; all-cause mortality ( ACM ) was a key secondary end point .
RESULTS	A differential association of MRA use by increasing Gal-3 concentration was tested with the use of interaction terms in Cox proportional hazards models , adjusted for covariates previously identified in this cohort as well as age , sex , and race .
RESULTS	Inverse propensity-weighted ( IPW ) methods were also used to assess this association .
RESULTS	Approximately one-half ( n = 401 ) of the patients were on an MRA .
RESULTS	There was no significant interaction for the associations of Gal-3 levels and MRA use for either end point ( adjusted interaction P = .76 for ACM+ACH ; P = .26 for ACM ) .
RESULTS	There was no evidence of improved outcomes for patients on an MRA compared with those not on MRA for either end point ( hazard ratio [ HR ] 1.02 , 95 % confidence interval [ CI ] 0.85-1 .23 , P = .8 ; and HR = 1.15 , 95 % CI [ 0.82-1 .61 ] , P = .4 ; respectively ) .
RESULTS	IPW analysis was consistent with the results of the adjusted analysis .
CONCLUSIONS	Our study showed no evidence of interaction between Gal-3 and treatment effect of MRA .
CONCLUSIONS	Whether biomarkers may be used to predict which patients may benefit from an mineralocorticoid receptor antagonist in HF requires further investigation .

###24911979
OBJECTIVE	This study investigated the effects of written emotional disclosure on a model of chronic pain in healthy women with and without trauma history .
METHODS	Participants were prescreened for their trauma history ( N = 78 ) and randomized to a disclosure or a control writing condition .
METHODS	Pain testing occurred either 1 day or 1 month after disclosure .
METHODS	Capsaicin was applied to the forearm to evoke spontaneous burning pain at the application site and mechanical secondary hyperalgesia in the surrounding untreated skin .
RESULTS	As hypothesized , the effect of disclosure on the area and intensity of secondary hyperalgesia depended on trauma history and time of testing ( F ( 1,69 ) 7.37 , p = .008 ) .
RESULTS	Disclosure increased secondary hyperalgesia in participants with trauma history compared with those without trauma when testing occurred 1 day after writing ( F ( 1,69 ) 5.27 , p .025 ) , whereas the opposite pattern was observed 1 month later ( F ( 1,69 ) 4.88 , p .031 ) .
RESULTS	Of the participants with trauma history in the disclosure condition , secondary hyperalgesia was reduced at 1 month compared with 1 day after writing ( p = .001 ) .
RESULTS	Moreover , greater use of positive emotional words predicted reduced secondary hyperalgesia at 1 month ( = -0.71 , p = .022 ) .
RESULTS	In contrast , disclosure had no effect on spontaneous pain .
CONCLUSIONS	Disclosure modulates secondary hyperalgesia observed in women with trauma history , producing a short-term enhancement and a long-term reduction .
CONCLUSIONS	This suggests that disclosure has a long-term protective effect that reduces sensitization of pain , which may explain the therapeutic effects of disclosure in patients with chronic pain .

###24568475
BACKGROUND	With recent progress in health science administration , a huge amount of data has been collected from thousands of subjects .
BACKGROUND	Statistical and computational techniques are very necessary to understand such data and to make valid scientific conclusions .
BACKGROUND	The purpose of this paper was to develop a statistical probability model and to predict future survival times for male breast cancer patients who were diagnosed in the USA during 1973-2009 .
METHODS	A random sample of 500 male patients was selected from the Surveillance Epidemiology and End Results ( SEER ) database .
METHODS	The survival times for the male patients were used to derive the statistical probability model .
METHODS	To measure the goodness of fit tests , the model building criterions : Akaike Information Criteria ( AIC ) , Bayesian Information Criteria ( BIC ) , and Deviance Information Criteria ( DIC ) were employed .
METHODS	A novel Bayesian method was used to derive the posterior density function for the parameters and the predictive inference for future survival times from the exponentiated Weibull model , assuming that the observed breast cancer survival data follow such type of model .
METHODS	The Markov chain Monte Carlo method was used to determine the inference for the parameters .
RESULTS	The summary results of certain demographic and socio-economic variables are reported .
RESULTS	It was found that the exponentiated Weibull model fits the male survival data .
RESULTS	Statistical inferences of the posterior parameters are presented .
RESULTS	Mean predictive survival times , 95 % predictive intervals , predictive skewness and kurtosis were obtained .
CONCLUSIONS	The findings will hopefully be useful in treatment planning , healthcare resource allocation , and may motivate future research on breast cancer related survival issues .

###24447501
OBJECTIVE	The effect of levosimendan on renal function in patients with low ejection fraction undergoing mitral valve surgery was investigated .
METHODS	A prospective , double-blinded , randomized clinical trial .
METHODS	Tertiary teaching and research hospital .
METHODS	Of a total of 147 patients , 128 patients completed the study .
METHODS	In the levosimendan group ( n = 64 ) , levosimendan was administered in addition to standard inotropic support ; whereas , in the control group ( n = 64 ) , only standard inotropic support was given .
METHODS	In the levosimendan group , a loading dose of levosimendan ( 6 g/kg ) was administered after removal of the aortic cross-clamp , followed by an infusion ( 0.1 g/kg/min ) in addition to standard inotropic therapy for 24 hours .
METHODS	In the control group , only standard inotropic therapy was administered .
METHODS	Preoperative characteristics , serum creatinine ( sCr ) levels , and estimated glomerular filtration rate ( eGFR ) were determined preoperatively , on postoperative days 1 , 3 , and 10 .
METHODS	Independent risk factors for renal replacement therapy ( RRT ) requirement were investigated with stepwise multivariate logistic regression analysis .
RESULTS	The primary endpoint was the effect of levosimendan on postoperative renal clearance ( sCr and eGFR ) .
RESULTS	The secondary endpoint was the effect of levosimendan on clinical outcomes ( length of intensive care unit and hospital stays , need for RRT ) .
RESULTS	Preoperative characteristics and eGFR were similar between the groups ( p > 0.05 ) .
RESULTS	On postoperative days 1 and 3 , sCr values were lower and eGFR values were higher in the levosimendan group in comparison with the control group ( p = 0.0001 , p = 0.009 , respectively ) .
RESULTS	Six patients ( 9.4 % ) in the levosimendan group and 10 patients ( 15.6 % ) in the control group required RRT therapy ( p = 0.284 ) .
RESULTS	Independent risk factors for need of RRT include preoperative sCr value between 1.2 to 2.09 mg/dL and2 .1 mg/dL ( p < 0.05 ) .
CONCLUSIONS	Perioperative treatment with levosimendan in addition to standard inotropic therapy in patients with a low ejection fraction undergoing mitral valve surgery improved immediate postoperative renal function and reduced need for RRT .

###25691677
OBJECTIVE	We have previously reported that radiotherapy ( RT ) added to androgen-deprivation therapy ( ADT ) improves survival in men with locally advanced prostate cancer .
OBJECTIVE	Here , we report the prespecified final analysis of this randomized trial .
METHODS	NCIC Clinical Trials Group PR .3 / Medical Research Council PR07/Intergroup T94-0110 was a randomized controlled trial of patients with locally advanced prostate cancer .
METHODS	Patients with T3-4 , N0/Nx , M0 prostate cancer or T1-2 disease with either prostate-specific antigen ( PSA ) of more than 40 g/L or PSA of 20 to 40 g/L plus Gleason score of 8 to 10 were randomly assigned to lifelong ADT alone or to ADT+RT .
METHODS	The RT dose was 64 to 69 Gy in 35 to 39 fractions to the prostate and pelvis or prostate alone .
METHODS	Overall survival was compared using a log-rank test stratified for prespecified variables .
RESULTS	One thousand two hundred five patients were randomly assigned between 1995 and 2005 , 602 to ADT alone and 603 to ADT+RT .
RESULTS	At a median follow-up time of 8 years , 465 patients had died , including 199 patients from prostate cancer .
RESULTS	Overall survival was significantly improved in the patients allocated to ADT+RT ( hazard ratio [ HR ] , 0.70 ; 95 % CI , 0.57 to 0.85 ; P < .001 ) .
RESULTS	Deaths from prostate cancer were significantly reduced by the addition of RT to ADT ( HR , 0.46 ; 95 % CI , 0.34 to 0.61 ; P < .001 ) .
RESULTS	Patients on ADT+RT reported a higher frequency of adverse events related to bowel toxicity , but only two of 589 patients had grade 3 or greater diarrhea at 24 months after RT. .
CONCLUSIONS	This analysis demonstrates that the previously reported benefit in survival is maintained at a median follow-up of 8 years and firmly establishes the role of RT in the treatment of men with locally advanced prostate cancer .

###25759248
BACKGROUND	Smoking prevalence rates among Dutch children increase rapidly after they transit to secondary school , in particular among children with a low socioeconomic status ( SES ) .
BACKGROUND	Web-based , computer-tailored programs supplemented with prompt messages may be able to empower children to prevent them from starting to smoke when they transit to secondary school .
OBJECTIVE	The main aim of this study is to evaluate whether computer-tailored feedback messages , with and without prompt messages , are effective in decreasing children 's smoking intentions and smoking behavior after 12 and 25 months of follow-up .
METHODS	Data were gathered at baseline ( T0 ) , and after 12 months ( T1 ) and 25 months ( T2 ) of follow-up of a smoking prevention intervention program called Fun without Smokes .
METHODS	A total of 162 schools were randomly allocated to a no-intervention control group , an intervention prompt group , or an intervention no-prompt group .
METHODS	A total of 3213 children aged 10 to 12 years old participated in the study and completed a Web-based questionnaire assessing their smoking intention , smoking behavior , and sociocognitive factors , such as attitude , social influence , and self-efficacy , related to smoking .
METHODS	After completion , children in the intervention groups received computer-tailored feedback messages in their own email inbox and those messages could be accessed on the intervention website .
METHODS	Children in the prompt group received prompt messages , via email and short message service ( SMS ) text messaging , to stimulate them to reuse the intervention website with nonsmoking content .
METHODS	Multilevel logistic regression analyses were performed using multiple imputations to assess the program effects on smoking intention and smoking behavior at T1 and T2 .
RESULTS	A total of 3213 children participated in the Fun without Smokes study at T0 .
RESULTS	Between T0 and T1 a total of 1067 children out of the original 3213 ( 33.21 % ) dropped out of the study .
RESULTS	Between T0 and T2 the number of children that did not participate in the final measurement was 1730 out of the original 3213 ( 53.84 % ) .
RESULTS	No significant program effects were observed for any of the intervention groups compared to the control group at T1 for the intention to engage in smoking-prompt , OR 0.67 ( 95 % CI 0.30-1 .50 ) , no-prompt , OR 0.76 ( 95 % CI 0.34-1 .67 ) - or for smoking behavior-prompt , OR 1.13 ( 95 % CI 0.13-9 .98 ) , no-prompt , OR 0.50 ( 95 % CI 0.04-5 .59 ) .
RESULTS	Similar nonsignificant program effects were found at T2 for the intention to start smoking-prompt , OR 0.78 ( 95 % CI 0.26-2 .32 ) , no-prompt , OR 1.31 ( 95 % CI 0.45-3 .82 ) - and smoking behavior-prompt , OR 0.53 ( 95 % CI 0.12-2 .47 ) , no-prompt , OR 1.01 ( 95 % CI 0.24-4 .21 ) .
CONCLUSIONS	This study showed that the Web-based , computer-tailored feedback messages with and without prompt messages were not effective in modifying children 's smoking intentions and smoking behavior as compared to no information .
CONCLUSIONS	Future smoking prevention interventions are recommended to start closer to the age of actual smoking uptake .
CONCLUSIONS	Furthermore , future studies on Web-based , computer-tailored smoking prevention programs should focus on assessing and controlling exposure to the educational content and the response to the prompt messages .
BACKGROUND	Netherlands Trial Register NTR3116 ; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3116 ( Archived by WebCite at http://www.webcitation.org/6O0wQYuPI ) .

###26028131
BACKGROUND	Routine resection of cavity shave margins ( additional tissue circumferentially around the cavity left by partial mastectomy ) may reduce the rates of positive margins ( margins positive for tumor ) and reexcision among patients undergoing partial mastectomy for breast cancer .
METHODS	In this randomized , controlled trial , we assigned , in a 1:1 ratio , 235 patients with breast cancer of stage 0 to III who were undergoing partial mastectomy , with or without resection of selective margins , to have further cavity shave margins resected ( shave group ) or not to have further cavity shave margins resected ( no-shave group ) .
METHODS	Randomization occurred intraoperatively after surgeons had completed standard partial mastectomy .
METHODS	Positive margins were defined as tumor touching the edge of the specimen that was removed in the case of invasive cancer and tumor that was within 1 mm of the edge of the specimen removed in the case of ductal carcinoma in situ .
METHODS	The rate of positive margins was the primary outcome measure ; secondary outcome measures included cosmesis and the volume of tissue resected .
RESULTS	The median age of the patients was 61 years ( range , 33 to 94 ) .
RESULTS	On final pathological testing , 54 patients ( 23 % ) had invasive cancer , 45 ( 19 % ) had ductal carcinoma in situ , and 125 ( 53 % ) had both ; 11 patients had no further disease .
RESULTS	The median size of the tumor in the greatest diameter was 1.1 cm ( range , 0 to 6.5 ) in patients with invasive carcinoma and 1.0 cm ( range , 0 to 9.3 ) in patients with ductal carcinoma in situ .
RESULTS	Groups were well matched at baseline with respect to demographic and clinicopathological characteristics .
RESULTS	The rate of positive margins after partial mastectomy ( before randomization ) was similar in the shave group and the no-shave group ( 36 % and 34 % , respectively ; P = 0.69 ) .
RESULTS	After randomization , patients in the shave group had a significantly lower rate of positive margins than did those in the no-shave group ( 19 % vs. 34 % , P = 0.01 ) , as well as a lower rate of second surgery for margin clearance ( 10 % vs. 21 % , P = 0.02 ) .
RESULTS	There was no significant difference in complications between the two groups .
CONCLUSIONS	Cavity shaving halved the rates of positive margins and reexcision among patients with partial mastectomy .
CONCLUSIONS	( Funded by the Yale Cancer Center ; ClinicalTrials.gov number , NCT01452399 . )

###24302192
OBJECTIVE	Nuclear and cytoplasmic competence of human oocyte is critical for future competence of the embryo upon which ultimately depends the outcome of an ART ( Assisted Reproductive Technology ) treatment .
OBJECTIVE	Follicular microenvironment in which the oocyte develops is crucial , and this must be taken into account particularly with the use of hormonal ovarian stimulation protocols .
OBJECTIVE	Inositol is an important element of the follicular environment and data support that its higher level in follicular fluid correlates with the development of a good oocyte .
OBJECTIVE	Aim of this study is to understand the effects of treatment with inositol on oocyte quality in a sample of patients undergoing ICSI ( Intracytoplasmic Sperm Injection ) .
METHODS	Assessment of oocyte/embryo quality and pregnancy rates in 149 patients divided , according to a controlled randomized pattern , into two groups : study group 1 treated with folic acid and inositol and control group 2 treated with folic acid alone .
RESULTS	The number of patients with excellent and good oocyte quality appears to be significantly higher in group 1 ( p = 0.02 ) , as shown , they significantly increased the number of embryos of grade A transferred in the group 1 ( p = 0.02 ) compared to group 2 , despite being completely similar averages of total embryos transferred ( total mean SD = 2.4 0.8 , group 1 mean SD = 2.4 0.8 , group 2 mean SD = 2.4 0.8 ) .
RESULTS	There is not any significant difference between groups 1 and 2 in the number of positivity to - hCG and in the number of biochemical pregnancies detected although it has a tendency to increase in the first and to decrease in the second for group 1 .
RESULTS	The increase in percentage of clinical pregnancies in group 1 was statistically significant ( p = 0.02 ) , whereas there was no apparent significance in the difference between the biochemical and clinical pregnancies in the two groups despite the positive trend in the study group .
CONCLUSIONS	Relying on `` inositol help '' to solidify our efforts , seems to be an easy path to help to deepen the effectiveness of its use in all patients still under 40 but with prior failed attempts at ICSI or diagnosed with PCOS or as `` poor responders '' .

###25090820
OBJECTIVE	Unsedated transnasal upper endoscopy ( TNE ) has been suggested as a more comfortable and safer method than unsedated transoral endoscopy ( TOE ) .
OBJECTIVE	However , the numbers of comparative trials are limited .
OBJECTIVE	The current study aimed to assess the tolerability , safety , and efficacy of TNE in endoscopy nave patients .
METHODS	The current study was designed as a randomized , prospective , parallel arm trial including all eligible patients referred for upper endoscopy .
METHODS	Patients were randomized with a 1:1 ratio to undergo either unsedated TOE using a standard endoscope or unsedated TNE using an ultrathin endoscope .
METHODS	Postprocedure , all patients were asked to complete a questionnaire to assess pain , discomfort , distress and tolerability using a 10 cm visual analog scale ( VAS ) .
METHODS	Patients ' expectations and future preferences were also determined by multiple choice questions .
METHODS	Endoscope insertion rate , procedure duration , and side-effects were recorded for each patient .
RESULTS	Each group included 200 patients .
RESULTS	With the exception of nasal pain , mean VAS scores were significantly lower in TNE patients when compared to TOE patients ( p = 0.0001 ) .
RESULTS	85 % and 54.5 % of patients in TNE and TOE groups , respectively , found the procedure better than expected ( p = 0001 ) .
RESULTS	A repeat procedure was significantly more acceptable for TNE than TOE ( 82.4 % and 60.5 % , respectively ) .
RESULTS	Endoscope insertion failed in 3.5 % of TNE patients .
RESULTS	Mild epistaxis was observed in 4 % of TNE patients .
CONCLUSIONS	Unsedated TNE was tolerated better in endoscopy naive patients than unsedated TOE in a large parallel arm trial .

###24843313
OBJECTIVE	Oxycodone is semi-synthetic opioid , oral and parenteral preparations have been widely used for acute and chronic pain .
OBJECTIVE	The aim of this study was to assess the efficacy and side effects of oxycodone and fentanyl in patient controlled analgesia ( PCA ) after laparoscopic cholecystectomy .
METHODS	A prospective , randomized , double-blind study was conducted .
METHODS	81 patients were randomly divided into two groups ; fentanyl ( 10 mcg fentanyl and 1.5 mg ketorolac ) and oxycodone group ( 1 mg oxycodone and 1.5 mg ketorolac ) .
METHODS	After the operation , a blinded observer assessed pain using a numerical rating scale ( NRS ) , infused PCA dose , side effects , sedation levels , and satisfaction .
RESULTS	Cumulative PCA dose of oxycodone group at 48 h ( 31.4 16.0 ml ) was significantly less than that of fentanyl group ( 43.8 23.1 ml , P = 0.009 ) .
RESULTS	Oxycodone group showed more nausea at 6-24 h after the operation ( P = 0.001 ) , but there was no difference in satisfaction score ( P = 0.073 ) .
RESULTS	There were no significant differences in other side effects , sedation and NRS scores between two groups .
CONCLUSIONS	Oxycodone showed comparable effects for pain relief compared to fentanyl in spite of less cumulative PCA dose .
CONCLUSIONS	Based on these results , we could conclude that oxycodone may be useful as an alternative to fentanyl for PCA after laparoscopic cholecystectomy .

###25250415
OBJECTIVE	To compare the visual and refractive out-comes of femtosecond laser-assisted LASIK with small-incision lenticule extraction ( SMILE ) in terms of visual acuity , contrast sensitivity , aberrations , and dry eye .
METHODS	A single-center prospective randomized study in which patients diagnosed as having myopia presenting for refractive correction were allocated to either a LASIK or SMILE group .
METHODS	The primary outcome measures were refractive efficacy , predictability , and safety , postoperative contrast sensitivity , aberrations , and dry eye status .
METHODS	Patients were followed up at days 1 and 15 and 3 months ; postoperative uncorrected visual acuity ( UCVA ) , aberrations , dry eye , and contrast sensitivity were recorded and compared to preoperative data .
METHODS	Two postoperative subjective questionnaires were used to assess pain , pricking sensation , redness , glare , and overall patient satisfaction .
RESULTS	At day 1 postoperatively , 48 ( 96 % ) of 50 eyes in the SMILE group achieved a UCVA of 20/20 compared with 46 ( 92 % ) of 50 eyes in the LASIK group .
RESULTS	At day 15 postoperatively , contrast sensitivity was similar in the two groups ( P = .15 ) , but by 3 months , it was better in the SMILE group than the LASIK group at all spatial frequencies ( P < .0001 ) .
RESULTS	At 3 months postoperatively , 42 ( 84 % ) eyes in each group achieved a UCVA of 20/20 , with 6 ( 12 % ) eyes in the SMILE group and 2 ( 4 % ) eyes in the LASIK group achieving 20/15 .
RESULTS	Higher-order aberrations at 3 months postoperatively were significantly higher in the LASIK group ( 0.437 + 0.103 pm ) than in the SMILE group ( 0.267 + 0.07 pm ; P < .001 ) .
RESULTS	Postoperative dry eye and glare were significantly more common following LASIK ( P < .001 ) .
CONCLUSIONS	Three-month results demonstrate that refractive accuracy , dry eye , contrast , and induced aberrations are better following SMILE rather than LASIK .

###24306011
OBJECTIVE	Therapies for post-traumatic stress disorder ( PTSD ) endorsed by the Department of Defense and Veterans Administration are relatively lengthy , costly , and yield variable success .
OBJECTIVE	We evaluated Accelerated Resolution Therapy ( ART ) for the treatment of combat-related psychological trauma .
METHODS	A randomized controlled trial of ART versus an Attention Control ( AC ) regimen was conducted among 57 U.S. service members/veterans .
METHODS	After random assignment , those assigned to AC were offered crossover to ART , with 3-month follow-up on all participants .
METHODS	Self-report symptoms of PTSD and comorbidities were analyzed among study completers and by the intention-to-treat principle .
RESULTS	Mean age was 41 13 years with 19 % female , 54 % Army , and 68 % with prior PTSD treatment .
RESULTS	The ART was delivered in 3.7 1.1 sessions with a 94 % completion rate .
RESULTS	Mean reductions in symptoms of PTSD , depression , anxiety , and trauma-related guilt were significantly greater ( p < 0.001 ) with ART compared to AC .
RESULTS	Favorable results for those treated with ART persisted at 3 months , including reduction in aggression ( p < 0.0001 ) .
RESULTS	Adverse treatment-related events were rare and not serious .
CONCLUSIONS	ART appears to be a safe and effective treatment for symptoms of combat-related PTSD , including refractory PTSD , and is delivered in significantly less time than therapies endorsed by the Department of Defense and Veterans Administration .

###25013000
BACKGROUND	Current treatments for low back pain have small effects .
BACKGROUND	A research priority is to identify patient characteristics associated with larger effects for specific interventions .
OBJECTIVE	The aim of this study was to identify simple clinical characteristics of patients with chronic low back pain who would benefit more from either motor control exercises or graded activity .
METHODS	This study was a secondary analysis of the results of a randomized controlled trial .
METHODS	One hundred seventy-two patients with chronic low back pain were enrolled in the trial , which was conducted in Australian physical therapy clinics .
METHODS	The treatment consisted of 12 initial exercise sessions over an 8-week period and booster sessions at 4 and 10 months following randomization .
METHODS	The putative effect modifiers ( psychosocial features , physical activity level , walking tolerance , and self-reported signs of clinical instability ) were measured at baseline .
METHODS	Measures of pain and function ( both measured on a 0-10 scale ) were taken at baseline and at 2 , 6 , and 12 months by a blinded assessor .
RESULTS	Self-reported clinical instability was a statistically significant and clinically important modifier of treatment response for 12-month function ( interaction : 2.72 ; 95 % confidence interval = 1.39 to 4.06 ) .
RESULTS	Participants with high scores on the clinical instability questionnaire ( 9 ) did 0.76 points better with motor control exercises , whereas those who had low scores ( < 9 ) did 1.93 points better with graded activity .
RESULTS	Most other effect modifiers investigated did not appear to be useful in identifying preferential response to exercise type .
CONCLUSIONS	The psychometric properties of the instability questionnaire have not been fully tested .
CONCLUSIONS	A simple 15-item questionnaire of features considered indicative of clinical instability can identify patients who respond best to either motor control exercises or graded activity .

###25802309
BACKGROUND	The multicomponent serogroup B meningococcal ( 4CMenB ) vaccine induces antibodies against indicator strains of serogroup B meningococcus under various schedules .
BACKGROUND	We investigated the persistence of antibodies in 5-year-old children 18-20 months after their last dose ( at about 3.5 years of age ) .
METHODS	We assessed 5-year-old children who received the 4CMenB vaccine or a recombinant protein vaccine in a previous randomized trial .
METHODS	We also recruited 50 vaccine-naive 5-year-olds and administered 2 doses of 4CMenB to each child .
METHODS	We measured serum bactericidal antibody titres against 4 indicator strains of serogroup B meningococcus matched to each individual vaccine component and against 4 mismatched strains .
RESULTS	Of those who received the 4CMenB vaccine at 2 , 4 , 6 , 12 and 40 months ( n = 16 ) , the percentage with protective antibody titres ( 1:4 ) at 60 months ranged from 44 % to 88 % against matched strains and from 13 % to 81 % against mismatched strains .
RESULTS	Loss of protective titres was also observed for those who received the 4CMenB vaccine at 12 , 40 and 42 months ( n = 5 ) ( 80 % -100 % against matched strains , 60 % -100 % against mismatched strains ) or at 40 and 42 months ( n = 29 ) ( 31 % -100 % against matched strains , 41 % -81 % against mismatched strains ) .
RESULTS	Administering the 4CMenB vaccine to 5-year-old children yielded protective titres against matched strains in 92 % -100 % and against mismatched strains in 59 % -100 % .
RESULTS	The majority of these children reported injection-site pain ( 40/50 [ 80 % ] after dose 1 , 39/46 [ 85 % ] after dose 2 ) and erythema ( 47/50 [ 94 % ] and 40/46 [ 87 % ] , respectively ) ; rates of fever were low ( 5/50 [ 10 % ] and 2/46 [ 4 % ] , respectively ) .
CONCLUSIONS	Waning of immunity by 5 years of age occurred after receipt of the 4CMenB vaccine in infancy , even with an additional booster at 40 months .
CONCLUSIONS	The 4CMenB vaccine is immunogenic and was fairly well tolerated by 5-year-old children , although injection-site pain was noteworthy .
BACKGROUND	ClinicalTrials.gov , no .
BACKGROUND	NCT01027351 .

###24755244
BACKGROUND	To evaluate the effect of drainage tube on prognosis after total knee arthroplasty ( TKA ) and explore an effective treatment with favorable prognosis .
METHODS	In a prospective study , 18 patients with TKA for the first time were included and randomly divided into three groups , group A ( no placement of drainage tube ) , group B ( negative pressure drainage ) , and group C ( 4 h clamping drainage ) .
METHODS	Intraoperative and postoperative blood loss , operation time , and the drainage volume were recorded and analyzed .
METHODS	Arthrocele , ecchymosis , and range of motion ( ROM ) were examined postoperatively .
METHODS	The degree of pain was scored by Visual Analog Scale ( VAS ) after 6 , 12 , and 24 h of operation .
METHODS	The complications were examined and HSS ( hospital for special surgery ) knee score was taken during the follow-up period .
RESULTS	There was no significant difference in operation time , total blood loss , intraoperative blood loss , and VAS score among three groups .
RESULTS	Meanwhile , the hidden blood loss in group B was significantly decreased compared with group A ( P = 0.0015 ) .
RESULTS	The postoperative drainage volume of group B was significantly increased compared with group C ( P = 0.0002 ) .
RESULTS	No drainage increased the rate of arthrocele and ecchymosis .
RESULTS	Compared with group A , ROM after 3 days of operation in groups B and C was significantly increased ( P = 0.0357 , P = 0.0372 , respectively ) .
RESULTS	During follow-up study , no deep infection or deep venous thrombosis was found .
CONCLUSIONS	After TKA , early clamping of the drainage tube reduced the bleeding loss without adverse effect on prognosis , which might be useful for clinical application in future .

###25148718
OBJECTIVE	The main goal of this study was to achieve a medico-economic comparison between four disposable laryngeal masks ( LM ) ( LMA-Unique , Ambu AuraOnce , I-Gel and LMA-Suprme ) .
METHODS	A prospective , randomized , monocentre study .
METHODS	In a center , using routinely LMA-Unique masks , scheduled breast surgery patients were allocated into four groups according to the LM model .
METHODS	After the induction , the modalities of use were collected , as well as the intraoperative events that required additional anesthetic equipment .
METHODS	The real cost of each model was calculated ( cost of the mask + extra cost related to complications ) .
METHODS	Using the LMA-Unique as a reference , we performed a cost-efficacy analysis .
METHODS	We realized a cost-efficiency analysis putting in parallel the impact on the cost and the incidence of the events .
RESULTS	A total of 178 patients were included .
RESULTS	According to the cost-efficacy analysis , the dominant model was the Ambu AuraOnce ( real cost : -34.2 % , events : -30.6 % ) .
RESULTS	The LMA-Unique was dominated because of a high morbidity rate .
RESULTS	The I-Gel and LMA-Suprme models were more efficient but more expensive ( real cost : +16 % and +22.5 % respectively ) .
RESULTS	To compensate for additional costs , it would be necessary to apply a price reduction of at least 50 % .
CONCLUSIONS	Despite their better efficiency and safety , the latest generation laryngeal masks are still expensive in spite of a low rate of complication .
CONCLUSIONS	These results do not take into account very rare and severe complications not met in this study in the limited size ; then the economic and medical impact can influence the choice beyond the simple analysis cost-efficiency .

###24647226
BACKGROUND	We evaluated the safety and efficacy of a novel disposable male circumcision ( MC ) device developed by Jiangxi-Yuansheng-Langhe Medical Instrument Co. , Ltd. .
METHODS	Adult male patients ( n = 120 ; mean age , 26.6 years ) with redundant foreskin and/or phimosis were included in a randomized , multicenter pilot clinical trial from October 2011 to February 2012 .
METHODS	Patients were divided into 2 groups and subjected to MC with a novel disposable device ( Device Group ) ( n = 60 ) or to conventional dissection technique ( CDT ) ( Control Group ) ( n = 60 ) .
METHODS	Intraoperative bleeding , surgery duration , pain , healing , and satisfaction with penis appearance were assessed .
METHODS	Adverse events ( AEs ) were noted .
RESULTS	Intraoperative bleeding volume [ 3.5 2.7 ( 15-35 ) ml vs. 13.1 6.1 ( 4-25 ) ml ] and mean surgical time [ 7.6 4.5 ( 2-23 ) min vs. 23.6 4.4 ( 15-35 ) min ] in the Device Group were significantly less than in the Control Group ( P < 0.01 ) .
RESULTS	No AEs were observed in either group .
RESULTS	There were no significant differences in postoperative pain , healing , or satisfaction with penis appearance between groups ( P > 0.05 ) .
CONCLUSIONS	This novel disposable circumcision device produced satisfactory preliminary adult MC results compared with CDT treatments .
CONCLUSIONS	This device may be broadly used in men , such as those with phimosis , who are ineligible for CDT .

###24875671
OBJECTIVE	Increased potassium intake is related to reduced blood pressure ( BP ) and reduced stroke rate .
OBJECTIVE	The effect of increased dietary potassium on endothelial function remains unknown .
OBJECTIVE	The aim was to determine the effect of increased dietary potassium from fruit and vegetables on endothelial function .
RESULTS	Thirty five healthy men and women ( age 32 12 y ) successfully completed a randomised cross-over study of 2 6 day diets either high or low in potassium .
RESULTS	Flow mediated dilatation ( FMD ) , BP , pulse wave velocity ( PWV ) , augmentation index ( AI ) and a fasting blood sample for analysis of Intercellular Adhesion Molecule-1 ( ICAM-1 ) , E-selectin , asymmetric dimethylarginine ( ADMA ) and endothelin-1 were taken on completion of each intervention .
RESULTS	Dietary change was achieved by including bananas and potatoes in the high potassium and apples and rice/pasta in the low potassium diet .
RESULTS	Dietary adherence was assessed using 6 day weighed food diaries and a 24 h urine sample .
RESULTS	The difference in potassium excretion between the two diets was 48 32 mmol/d ( P = 0.000 ) .
RESULTS	Fasting FMD was significantly improved by 0.6 % 1.5 % following the high compared to the low potassium diet ( P = 0.03 ) .
RESULTS	There were no significant differences in BP , PWV , AI , ICAM-1 , ADMA or endothelin-1 between the interventions .
RESULTS	There was a significant reduction in E-selectin following the high ( Median = 5.96 ng/ml ) vs the low potassium diet ( Median = 6.24 ng/ml ) , z = -2.49 , P = 0.013 .
CONCLUSIONS	Increased dietary potassium from fruit and vegetables improves FMD within 1 week in healthy men and women but the mechanisms for this effect remain unclear .
BACKGROUND	ACTRN12612000822886 .

###25365713
METHODS	Spine Patient Outcomes Research Trial subgroup analysis .
OBJECTIVE	To evaluate the effect of high obesity on management of lumbar spinal stenosis , degenerative spondylolisthesis ( DS ) , and intervertebral disc herniation ( IDH ) .
BACKGROUND	Prior Spine Patient Outcomes Research Trial analyses compared nonobese and obese patients .
BACKGROUND	This study compares nonobese patients ( body mass index < 30 kg/m ) with those with class I obesity ( body mass index = 30-35 kg/m ) and class II/III high obesity ( body mass index35 kg/m ) .
METHODS	For spinal stenosis , 250 of 634 nonobese patients , 104 of 167 obese patients , and 59 of 94 highly obese patients underwent surgery .
METHODS	For DS , 233 of 376 nonobese patients , 90 of 129 obese patients , and 66 of 96 highly obese patients underwent surgery .
METHODS	For IDH , 542 of 854 nonobese patients , 151 of 207 obese patients , and 94 of 129 highly obese patients underwent surgery .
METHODS	Outcomes included Short Form-36 , Oswestry Disability Index , stenosis/sciatica bothersomeness index , low back pain bothersomeness index , operative events , complications , and reoperations .
METHODS	Operative and nonoperative outcomes were compared by change from baseline at each follow-up interval using a mixed effects longitudinal regression model .
METHODS	An as-treated analysis was performed because of crossover between surgical and nonoperative groups .
RESULTS	Highly obese patients had increased comorbidities .
RESULTS	Baseline Short Form-36 physical function scores were lowest for highly obese patients .
RESULTS	For spinal stenosis , surgical treatment effect and difference in operative events among groups were not significantly different.For DS , greatest treatment effect for the highly obese group was found in most primary outcome measures , and is attributable to the significantly poorer nonoperative outcomes .
RESULTS	Operative times and wound infection rates were greatest for highly obese patients.For IDH , highly obese patients experienced less improvement postoperatively compared with obese and nonobese patients .
RESULTS	However , nonoperative treatment for highly obese patients was even worse , resulting in greater treatment effect in almost all measures .
RESULTS	Operative time was greatest for highly obese patients .
RESULTS	Blood loss and length of stay was greater for both obese cohorts .
CONCLUSIONS	Highly obese patients with DS experienced longer operative times and increased infection .
CONCLUSIONS	Operative time was greatest for highly obese patients with IDH .
CONCLUSIONS	DS and IDH saw greater surgical treatment effect for highly obese patients due to poor outcomes of nonsurgical management .
METHODS	3 .

###24754961
BACKGROUND	Laparoscopy training courses have been established in many centers worldwide to ensure adequate skill learning before performing operations on patients .
BACKGROUND	Different training modalities and their combinations have been compared regarding training effects .
BACKGROUND	Multimodality training combines different approaches for optimal training outcome .
BACKGROUND	However , no standards currently exist for the number of trainees assigned per workplace .
METHODS	This is a monocentric , open , three-arm randomized controlled trial .
METHODS	The participants are laparoscopically-naive medical students from Heidelberg University .
METHODS	After a standardized introduction to laparoscopic cholecystectomy ( LC ) with online learning modules , the participants perform a baseline test for basic skills and LC performance on a virtual reality ( VR ) trainer .
METHODS	A total of 100 students will be randomized into three study arms , in a 2:2:1 ratio .
METHODS	The intervention groups participate individually ( Group 1 ) or in pairs ( Group 2 ) in a standardized and structured multimodality training curriculum .
METHODS	Basic skills are trained on the box and VR trainers .
METHODS	Procedural skills and LC modules are trained on the VR trainer .
METHODS	The control group ( Group C ) does not receive training between tests .
METHODS	A post-test is performed to reassess basic skills and LC performance on the VR trainer .
METHODS	The performance of a cadaveric porcine LC is then measured as the primary outcome using standardized and validated ratings by blinded experts with the Objective Structured Assessment of Technical Skills .
METHODS	The Global Operative Assessment of Laparoscopic Surgical skills score and the time taken for completion are used as secondary outcome measures as well as the improvement of skills and VR LC performance between baseline and post-test .
METHODS	Cognitive tests and questionnaires are used to identify individual factors that might exert influence on training outcome .
CONCLUSIONS	This study aims to assess whether workplaces in laparoscopy training courses for beginners should be used by one trainee or two trainees simultaneously , by measuring the impact on operative performance and learning curves .
CONCLUSIONS	Possible factors of influence , such as the role of observing the training partner , exchange of thoughts , active reflection , model learning , motivation , pauses , and sympathy will be explored in the data analysis .
CONCLUSIONS	This study will help optimize the efficiency of laparoscopy training courses .
BACKGROUND	DRKS00004675 .

###24874781
BACKGROUND	Limited time and lack of knowledge are barriers to physical activity counseling in primary care .
BACKGROUND	The objective of this study was to examine the effectiveness of a clinician-targeted intervention that used the 5As ( Ask , Advise , Agree , Assist , Arrange ) approach to physical activity counseling in a medically underserved patient population .
METHODS	Family medicine clinicians at 2 community health centers were randomized to Group 1 or Group 2 intervention .
METHODS	Both clinician groups participated in 4 training sessions on the 5As for physical activity counseling ; Group 2 training took place 8 months after Group 1 training .
METHODS	Both groups were trained to refer patients to a community exercise program .
METHODS	We used a pre-post analysis to evaluate the effectiveness of the intervention on clinician use of 5As .
METHODS	Eligible patients ( n = 319 ) rated their clinicians ' counseling skills by using a modified Physical Activity Exit Interview ( PAEI ) survey .
METHODS	Clinicians ( n = 10 ) self-assessed their use of the 5As through a survey and interviews .
RESULTS	Both patient and clinician groups had similar sociodemographic characteristics .
RESULTS	The PAEI score for both groups combined increased from 6.9 to 8.6 ( on a scale of 0-15 ) from baseline to immediately postintervention ( P = .01 ) and was 8.2 ( P = .09 ) at 6-month follow-up ; most of the improvement in PAEI score was due to increased use of 5As skills by Group 2 clinicians .
RESULTS	Group 1 reported difficulty with problem solving , whereas Group 2 reported ease of referral to the community exercise program .
CONCLUSIONS	A clinician training intervention showed mixed results for 5As physical activity counseling .

###24994555
OBJECTIVE	Antipsychotics , such as aripiprazole and risperidone , are often used to treat individuals with schizophrenia .
OBJECTIVE	The efficacy as well as safety of aripiprazole in Western populations has been described .
OBJECTIVE	The objective of this study is to investigate the efficacy , safety , and tolerability of aripiprazole and risperidone in Chinese Han schizophrenia subjects in mainland China .
METHODS	The 6-week , double-blind , randomized , parallel study was conducted in 5 medical centers in mainland China from November 2007 to March 2011 .
METHODS	A total of 279 subjects with a primary DSM-IV diagnosis of schizophrenia were randomly assigned ( with a randomization ratio of 1:1 ) to aripiprazole ( n = 139 ) or risperidone ( n = 140 ) .
METHODS	Efficacy measurements included the Positive and Negative Syndrome Scale ( PANSS ) total , positive , negative and general psychopathology subscale scores , and Clinical Global Impressions-Severity of Illness ( CGI-S ) , and Improvement scale scores .
METHODS	Extrapyramidal symptoms ( EPS ) , weight gain , serum prolactin level , QTc interval , and self-reported adverse events were also assessed as measures of safety and tolerability .
RESULTS	Both the aripiprazole and risperidone groups showed statistically significant improvement of PANSS total , positive , negative , general psychopathology subscale scores , and CGI-S scores from baseline to the endpoint ( all p < 0.01 ) .
RESULTS	Significant improvement was noted in the first week for both treatment groups .
RESULTS	There were no significant differences in efficacy measurements between the two treatment groups .
RESULTS	Mean change of PANSS total scores from baseline to the endpoint was -26.818.1 for aripiprazole and -30.017.7 for risperidone , ( p = 0.1475 ) .
RESULTS	The responder rate was 71 % ( n = 99 ) and 76 % ( n = 107 ) for aripiprazole and risperidone , respectively , ( p = 0.323 ) .
RESULTS	The incidences of EPS were similar in the aripiprazole ( 25 % , n = 35 ) and risperidone groups ( 24 % , n = 34 ) , respectively ( p = 0.757 ) .
RESULTS	No clinically meaningful effects on QTc interval , QRS duration , or PR interval were observed in either treatment groups .
RESULTS	However , the incidence of clinically significant weight gain ( p = 0.0118 ) and hyperprolactinemia ( p < 0.001 ) in the aripiprazole group was significantly lower than in the risperidone group .
CONCLUSIONS	The study demonstrated that aripiprazole , as well as risperidone , had rapid and persistent efficacy for psychotic symptoms from the first week of therapy .
CONCLUSIONS	There may be poor efficacy for aripiprazole compared with risperidone for overall improvement , but there were no significant differences in this study .
CONCLUSIONS	Aripiprazole showed good tolerability with less weight gain and hyperprolactinemia compared with risperidone .
CONCLUSIONS	The overall efficacy and safety of aripiprazole in Chinese Han schizophrenia subjects were similar to that reported in Western populations .

###25428342
OBJECTIVE	To observe the effectiveness and safety of Kangquan Recipe ( , KQR ) for benign prostatic hyperplasia ( BPH ) patients .
METHODS	One hundred and six BPH patients were randomly assigned to the treatment group ( 53 cases ) and the control group ( 53 cases ) according to a random number table .
METHODS	The treatment group was given KQR orally ; the control group was given cernilton orally .
METHODS	After 24-week treatment , the clinical effect and safety were evaluated using the International Prostatic Symptom Score ( I-PSS ) , quality of life ( QOL ) , maximum flow rate ( Qmax ) , average flow rate ( Qave ) , residual urine volume ( RUV ) , total prostatic volume ( TPV ) , etc. .
RESULTS	After treatment , the score of I-PSS was decreased from 16.95.6 to 12.54.6 in the treatment group , significantly lower compared with the control group ; the levels of Qmax and Qave were from 10.93.5 to 15.64.5 and 5.42.1 to 7.32.5 ( mL/s ) in the treatment group , significantly higher compared with the control group ; the levels of RUV and TPV were from 70.828.2 to 35.221.8 and 37.216.9 to 30.110.8 ( mL ) in the treatment group , significantly lower compared with the control group ( all P < 0.05 ) .
RESULTS	The incidence rate of adverse reaction was similar between the two groups ( P > 0.05 ) .
CONCLUSIONS	KQR is effective and safe for the treatment of BPH .

###24964294
BACKGROUND	Overweight or obesity is prevalent among college students and many gain weight during this time .
BACKGROUND	Traditional face-to-face weight loss interventions have not worked well in this population .
BACKGROUND	Facebook is an attractive tool for delivering weight loss interventions for college students because of its popularity , potential to deliver strategies found in successful weight loss interventions , and ability to support ongoing adaptation of intervention content .
OBJECTIVE	The objective of this study was to describe participant exposure to a Facebook page designed to deliver content to overweight/obese college students in a weight loss randomized controlled trial ( N = 404 ) and examine participant engagement with behavior change campaigns for weight loss delivered via Facebook .
METHODS	The basis of the intervention campaign model were 5 self-regulatory techniques : intention formation , action planning , feedback , goal review , and self-monitoring .
METHODS	Participants were encouraged to engage their existing social network to meet their weight loss goals .
METHODS	A health coach moderated the page and modified content based on usage patterns and user feedback .
METHODS	Quantitative analyses were conducted at the Facebook post - and participant-level of analysis .
METHODS	Participant engagement was quantified by Facebook post type ( eg , status update ) and interaction ( eg , like ) and stratified by weight loss campaign ( sequenced vs nonsequenced ) .
METHODS	A subset of participants were interviewed to evaluate the presence of passive online engagement or `` lurking . ''
RESULTS	The health coach posted 1816 unique messages to the study 's Facebook page over 21 months , averaging 3.45 posts per day ( SD 1.96 , range 1-13 ) .
RESULTS	In all , 72.96 % ( 1325/1816 ) of the posts were interacted with at least once ( eg , liked ) .
RESULTS	Of these , approximately 24.75 % ( 328/1325 ) had 1-2 interactions , 23.39 % ( 310/1325 ) had 3-5 interactions , 25.13 % ( 333/1325 ) had 6-8 interactions , and 41 posts had 20 or more interactions ( 3.09 % , 41/1325 ) .
RESULTS	There was significant variability among quantifiable ( ie , visible ) engagement .
RESULTS	Of 199 participants in the final intervention sample , 32 ( 16.1 % ) were highly active users and 62 ( 31.2 % ) never visibly engaged with the intervention on Facebook .
RESULTS	Polls were the most popular type of post followed by photos , with 97.5 % ( 79/81 ) and 80.3 % ( 386/481 ) interacted with at least once .
RESULTS	Participants visibly engaged less with posts over time ( partial r = -.33 ; P < .001 ) .
RESULTS	Approximately 40 % of the participants interviewed ( 12/29 , 41 % ) reported passively engaging with the Facebook posts by reading but not visibly interacting with them .
CONCLUSIONS	Facebook can be used to remotely deliver weight loss intervention content to college students with the help of a health coach who can iteratively tailor content and interact with participants .
CONCLUSIONS	However , visible engagement with the study 's Facebook page was highly variable and declined over time .
CONCLUSIONS	Whether the level of observed engagement is meaningful in terms of influencing changes in weight behaviors and outcomes will be evaluated at the completion of the overall study .

###25460261
OBJECTIVE	Recent research suggests that safety behaviors ( SB ) may not preclude treatment gains in exposure-based therapy for obsessive-compulsive disorder .
OBJECTIVE	However , it is relatively unknown what specific types of SBs may be detrimental to the therapeutic process , with some arguing that SBs be classified based on their function .
OBJECTIVE	The current study sought to examine the extent to which different SBs enhanced or weakened symptoms of contamination fear during a single session of exposure .
METHODS	Sixty-seven non-clinical students were randomly assigned to one of three conditions : ( 1 ) exposure with no SBs ( NSB ) , ( 2 ) exposure with preventive SBs ( PSB ) , or ( 3 ) exposure with restorative SBs ( RSB ) .
RESULTS	Among the primary outcome measures , greater reductions in fear and behavioral avoidance were found for RSB in comparison to PSB , and the gains made by RSB were generalizable to other sources of potential contamination .
RESULTS	Furthermore , RSB resulted in more rapid reductions in fear and disgust across repeated exposure trials .
CONCLUSIONS	Limitations include the use of a nonclinical student sample .
CONCLUSIONS	Overall , the current study suggests that RSB may be beneficial as an adjunct to therapy whereas PSB are potentially detrimental .
CONCLUSIONS	Results of the study are discussed in terms of exposure theories and the treatment of anxiety disorders .

###25367544
OBJECTIVE	To compare the effects of two 9-month parent-implemented interventions within the Early Social Interaction ( ESI ) Project .
OBJECTIVE	Both individual-ESI , offered 2 or 3 times per week at home or in the community , and group-ESI , offered once per week in a clinic , taught parents how to embed strategies to support social communication throughout everyday activities .
METHODS	Participants in the randomized controlled trial included 82 children diagnosed with autism spectrum disorder at 16 to 20 months .
METHODS	Children were matched on pretreatment nonverbal developmental level and pairs were randomly assigned to treatment condition .
METHODS	Child outcomes included measures of social communication , autism symptoms , adaptive behavior , and developmental level .
METHODS	Child outcomes are reported from baseline to the end of the 9-month interventions .
RESULTS	Children in individual-ESI showed differential change on a standardized examiner-administered observational measure of social communication , as they improved at a faster rate than children in group-ESI .
RESULTS	Individual-ESI also showed differential efficacy on a parent report measure of communication , daily living , and social skills , as they showed improvement or stability , whereas group-ESI led to worsening or no significant change on these skills .
RESULTS	Finally , individual-ESI showed differential change on examiner-administered measures of receptive language skills , as children in individual-ESI improved significantly , whereas group-ESI showed no change .
CONCLUSIONS	These findings support the efficacy of individual-ESI compared with group-ESI on child outcomes , suggesting the importance of individualized parent coaching in natural environments .
CONCLUSIONS	The efficacy of a parent-implemented intervention using little professional time has potential for community viability , which is particularly important in light of the lack of main effects on child outcomes of most other parent-implemented interventions .

###25895909
BACKGROUND	Japanese cedar ( JC ) pollinosis is the most common seasonal allergic rhinitis in Japan .
BACKGROUND	Standardized JC pollen extract is available for subcutaneous immunotherapy , but this treatment is limited by potentially serious side effects .
BACKGROUND	The aim of this double-blind , randomized comparative study was to evaluate the efficacy and safety of standardized JC pollen extract in a new oral formulation ( CEDARTOLEN , Torii Pharmaceutical Co. , Ltd. , Tokyo , Japan ) for sublingual immunotherapy ( SLIT ) for JC pollinosis .
METHODS	A total of 531 subjects with JC pollinosis were randomized into 2 groups at a ratio of 1:1 to receive daily sublingual administration of standardized JC pollen extract with a maintenance dose of 2,000 Japanese allergy units ( JAU ) or placebo for 2 consecutive pollen seasons .
METHODS	The efficacy was evaluated using the total nasal symptom and medication score ( TNSMS ) as the primary end point .
METHODS	Secondary end points included the total ocular symptom and medication score ( TOSMS ) and scores for individual symptoms and medication .
RESULTS	The TNSMS was significantly lower ( p < 0.0001 ) in the SLIT group than in the placebo group in the peak symptom period by 18 and 30 % in the first and second seasons , respectively .
RESULTS	All secondary end points were also significantly lower in the SLIT group in both seasons .
RESULTS	No systemic anaphylaxis occurred .
CONCLUSIONS	SLIT with daily administration of standardized JC pollen extract was effective for improving nasal and ocular symptoms of JC pollinosis and reducing the use of relief medication .
CONCLUSIONS	The JC pollen extract was well tolerated with only local adverse events .

###24332123
OBJECTIVE	To investigate the treatment outcome of discontinuing 1 medication from 2-year combination therapy for male benign prostatic hyperplasia/lower urinary tract symptoms .
METHODS	Patients with International Prostate Symptom Score 8 , total prostatic volume ( TPV ) > 30 mL , and maximum flow rate ( Qmax ) < 15 mL/s were randomly assigned to the 5-reductase inhibitor ( 5ARI ) discontinue ( DC-5ARI ) or - blocker discontinue ( DC -- blocker ) group .
METHODS	All patients received combination therapy with dutasteride ( 0.5 mg QD ) and doxazosin ( 4 mg QD ) for 2 years and then discontinued either one drug for 12 months .
METHODS	The primary endpoint was the occurrence of resuming medication .
METHODS	The secondary endpoints were the net parameters changed or the need of transurethral resection of the prostate ( TURP ) .
RESULTS	A total of 117 patients in DC-5ARI and 113 in DC -- blocker group completed the study .
RESULTS	The baseline TPV and Qmax were similar between groups before combination therapy .
RESULTS	Resumption of combination therapy was significantly more in DC-5ARI than DC -- blocker group ( 51.3 % vs 31.0 % ; P = .005 ) .
RESULTS	The mean duration from discontinuing to resuming medication was 5.0 4.4 months in DC -- blocker and 7.8 3.8 months in DC-5ARI group ( P < .05 ) .
RESULTS	The TPV progression ( 29.1 % vs 8.0 % ; P < .001 ) and the need for TURP ( 14.5 % vs 7.1 % ; P = .043 ) were significantly higher in DC-5ARI than DC -- blocker group .
RESULTS	Patients with larger TPV ( 45.8 18.1 mL ) had significantly greater need for resuming 5ARI than smaller TPV ( 36.3 16.9 mL ; P = .007 ) , and a lower Qmax might predict resuming - blocker .
CONCLUSIONS	After a 2-year combination therapy , discontinuation of either one drug induced benign prostatic hyperplasia progression in either group .
CONCLUSIONS	Greater risk of resuming medication and needing TURP were noted in patients who discontinued 5ARI .

###24690589
OBJECTIVE	A combined heart rate ( HR ) and motion sensor ( Actiheart ) has been proposed as an accurate method for assessing total energy expenditure ( TEE ) and physical activity energy expenditure ( PAEE ) .
OBJECTIVE	However , the extent to which factors such as caffeine may affect the accuracy by which the estimated HR-related PAEE contribution will affect TEE and PAEE estimates is unknown .
OBJECTIVE	Therefore , we examined the validity of Actiheart in estimating TEE and PAEE in free-living adults under a caffeine trial compared with doubly labeled water ( DLW ) as reference criterion .
METHODS	Using a double-blind crossover trial ( Clinicaltrials.gov ID : #NCT 01477294 ) with two conditions ( 4-day each with a 3-day-washout period ) , randomly ordered as caffeine ( 5 mg/kg per day ) and placebo ( malt-dextrine ) intake , TEE was measured by DLW in 17 physically active men ( 20-38 years ) who were non-caffeine users .
METHODS	In each condition , resting energy expenditure ( REE ) was assessed by indirect calorimetry and PAEE was calculated as ( TEE - ( REE +0.1 TEE ) ) .
METHODS	Simultaneously , PAEE and TEE were estimated by Actiheart using an individual calibration ( ACC+HR step ) .
RESULTS	Under caffeine , ACC+HR step explained 76 and 64 % of TEE and PAEE from DLW , respectively ; corresponding results for the placebo condition were 82 and 66 % .
RESULTS	No mean bias was found between ACC+HR step and DLW for TEE ( caffeine : -468 kJ per day ; placebo : -407 kJ per day ) , although PAEE was slightly underestimated ( caffeine : -856 kJ per day ; placebo : -1147 kJ per day ) .
RESULTS	Similar limits of agreement were observed in both conditions ranging from -2066 to 3002 and from -3488 to 1776 kJ per day for TEE and PAEE , respectively .
CONCLUSIONS	Regardless of caffeine intake , the combined HR and motion sensor is valid for estimating free-living energy expenditure in a group of healthy men but is less accurate for an individual assessment .

###24804842
OBJECTIVE	The purpose of the study was to assess the impact of dutasteride plus tamsulosin combination therapy , compared with dutasteride or tamsulosin monotherapy , on nocturia in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia ( LUTS/BPH ) using data from the 4-year CombAT study .
METHODS	Nocturia was assessed using Question 7 of the International Prostate Symptom Score questionnaire .
METHODS	Efficacy measures included as follows : mean change in nocturia at 3-month intervals up to 48 months ; proportion of patients with improvement/worsening in nocturia ; nocturnal voiding frequency at baseline and study end , overall and by baseline subgroups ; and nocturnal voiding frequency < 2 at study end in patients with a baseline score 2 .
RESULTS	In total , 4,722 patients with a mean age of 66 years were included .
RESULTS	Mean nocturia improvements were significantly superior ( p 0.01 ) with combination therapy than with either monotherapy ( adjusted mean change from baseline in IPSS Question 7 score at month 48 : combination therapy -0.5 , dutasteride -0.4 , tamsulosin -0.3 ) .
RESULTS	Reduction in nocturia score with combination therapy was significantly ( p 0.01 ) better than tamsulosin monotherapy across all baseline subgroups tested , except for men with previous 5ARI use .
RESULTS	Among those with a baseline IPSS Q7 score 2 , more patients with combination therapy had a score < 2 at month 48 ( 34 % ) compared with dutasteride ( 30 % , p = 0.018 ) or tamsulosin ( 26 % , p < 0.0001 ) .
CONCLUSIONS	Combination therapy provided greater improvements and less worsening of nocturia compared with both dutasteride and tamsulosin monotherapies .
CONCLUSIONS	These analyses are the first to show greater improvement with a 5ARI / - blocker combination versus either agent alone for the management of nocturia in patients with LUTS/BPH .

###24389520
BACKGROUND	Acute stress can increase fatigability and decrease steadiness of sustained low-force contractions that are required for functional tasks in upper limb muscles .
BACKGROUND	Whether motor performance is more impaired in people with a chronic stress disorder is not known .
OBJECTIVE	This study compared the fatigability and steadiness ( force fluctuations ) of handgrip muscles in veterans with posttraumatic stress disorder ( PTSD ) and civilian controls in the presence and absence of varying levels of cognitive demand .
METHODS	Eighteen veterans with PTSD and 21 healthy controls ( 33 9 yr ) attended three randomized experimental sessions to perform an isometric fatiguing contraction ( 20 % of maximal strength ) with the handgrip muscles .
METHODS	Two sessions involved performing a cognitive task during the fatiguing contraction : 1 ) difficult mental math task ( stressor ) and 2 ) a simple mental math task ( mental attentiveness ) .
METHODS	A third session involved a fatiguing contraction with no mental task ( control ) .
RESULTS	Stress elevated heart rate , blood pressure , and levels of anxiety in veterans with PTSD ( P < 0.05 ) but blunted cortisol levels ( P < 0.05 ) .
RESULTS	Time to failure was briefer ( 7.2 2.5 vs 9.3 5.2 min , P = 0.03 ) , and force fluctuations increased at a greater rate for veterans with PTSD than for controls ( P < 0.05 ) .
RESULTS	Cognitive stress did not influence time to failure or force fluctuations for either group ( P > 0.05 ) .
CONCLUSIONS	Veterans with PTSD demonstrated greater fatigability and loss of steadiness ( greater force fluctuations ) of the handgrip muscles compared with healthy controls .
CONCLUSIONS	Male veterans with PTSD demonstrated altered neuromuscular function of arm muscles that potentially affects functional tasks during daily , ergonomic , and military activities .

###25827693
OBJECTIVE	For patients with diabetes and triple-vessel disease , coronary artery bypass grafting ( CABG ) surgery is a well-established procedure , but cardiopulmonary bypass support may also lead to severe complications to these patients .
OBJECTIVE	The aim of this study was to compare myocardial protection and early outcomes in patients with diabetes and triple-vessel disease following different coronary surgical techniques .
METHODS	Prospective randomized trial of patients treated at the First Affiliated Hospital of China Medical University over a 3-year period ( 2011 - 2013 ) .
METHODS	In a single-center randomized trial , 668 patients with diabetes and triple-vessel disease were randomly assigned to off-pump ( OPCAB ) ( number [ n ] = 222 ) , on-pump beating heart ( OnP-BH ) ( n = 223 ) , and conventional CABG ( OnP ) ( n = 223 ) between January 2011 and October 2013 .
METHODS	Myocardial injury was assessed by measuring the serial release of cardiac troponin I ( cTnI ) preoperatively , 1 hour , 12 hours , 24 hours , and 72 hours postoperatively .
METHODS	The early outcomes were compared among these 3 groups .
RESULTS	Preoperative characteristics of the patients in all 3 groups were similar .
RESULTS	No significant difference was found regarding the number of anastomoses , the use of the internal thoracic artery , postoperative new-onset atrial fibrillation , hemodialysis , stroke , reoperation for bleeding , and infective complications in the 3 groups ( P > .05 ) .
RESULTS	The complete revascularization , postoperative drainage loss , intra-aortic balloon pump support , blood requirements , postoperative myocardial infarction , pulmonary complications , gastrointestinal complications , inotropic requirements > 24 hours , ventilation > 24 hours , intensive care unit stay > 24 hours , and in-hospital stay > 7 days were significantly lower in the OPCAB group than in the other 2 groups ( P < .05 ) .
RESULTS	In-hospital mortality was lower in the OPCAB group than in the other 2 groups , but no statistical difference was observed ( P > .05 ) .
RESULTS	Preoperative cTnI in the 3 groups was similar ( P > .05 ) ; however , the lowest cTnI value was noted in the OPCAB group , followed by the OnP group , and it was highest in the OnP-BH group 1 hour , 12 hours , 24 hours , and 72 hours postoperatively ( P < .05 ) .
CONCLUSIONS	OPCAB is superior to the OnP-BH and OnP techniques in terms of postoperative complications and myocardial protection in patients with diabetes and triple-vessel disease .
CONCLUSIONS	Myocardial injury in the OnP-BH group was significantly higher than that in the OnP group .

###24504222
OBJECTIVE	This study aims to investigate and evaluate the efficacy and safety of early enteral nutrition ( EN ) in maintaining and improving the postoperative nutritional status in patients undergoing esophagectomy .
METHODS	A randomized , controlled clinical trial was conducted in 120 adult patients with esophageal cancer and undergoing esophagectomy .
METHODS	Patients were randomly divided into two groups receiving either EN ( N. = 64 ) or parenteral nutrition ( PN ) ( N. = 56 ) postoperatively .
METHODS	The nutritional intake was isonitrogenic and isocalorie for both groups .
METHODS	Nutritional status was evaluated preoperatively as well as on postoperative day I and day 8 .
METHODS	Daily nitrogen balance was measured and 7-day cumulative nitrogen balance was calculated .
METHODS	The levels of serum markers including d-lactate , diamine oxidase ( DAO ) , and endotoxin were determined on 1st , 4th and 8th postoperative day for analyzing intestinal barrier function .
METHODS	Postoperative infection rate and the incidence of nutrition support-related complications were examined .
RESULTS	The concentrations of serum albumin and prealbumin in patients of EN group were significantly higher than those in PN group and the concentrations of blood glucose , - GT , AKP , TB , and DB were significantly lower compared to those in the PN group ( P < 0.05 ) .
RESULTS	Both daily nitrogen balance and cumulative nitrogen balance of EN group were better than those of PN group since postoperative day III .
RESULTS	The serum levels of d-lactate , DAO , and endotoxin of EN group were significantly lower than those of PN group on postoperative day VIII ( P < 0.01 ) .
RESULTS	The incidence of postoperative infections in blood , lung , and intestinal tract in EN group was lower compared to PN group ( P < 0.05 ) .
RESULTS	No severe complications associated with nutritional support occurred in EN group .
RESULTS	The time to flatus passage in EN group was significantly shorter , and the cost of nutritional support was significantly less compared to PN group ( P < 0.05 ) .
CONCLUSIONS	Postoperative early enteral nutrition was safe and feasible for patients undergoing esophagectomy .
CONCLUSIONS	Compared to PN , EN more efficiently ameliorated postoperational nutritional status of the patients undergoing esophagectomy , played an important role in restoring intestinal barrier function postoperatively , reduced the incidence of postoperative infection , and decreased the cost of hospital stay .

###24229746
OBJECTIVE	Intravenous N-methyl-d-aspartate ( NMDA ) antagonists have shown promising results in rapidly ameliorating depression symptoms , but placebo-controlled trials of oral NMDA antagonists as monotherapy have not observed efficacy .
OBJECTIVE	We conducted a randomized , double-blind , placebo-controlled trial of the NMDA antagonist memantine as an augmentation treatment for patients with DSM-IV major depressive disorder .
METHODS	Adult outpatients with major depressive disorder and partial response or nonresponse to their current antidepressant ( as indicated by a 17-item Hamilton Depression Rating Scale score of 16 at baseline ) were randomized ( from July 2006-December 2011 ) to add memantine ( flexible dose 5-20 mg/d , with all memantine group participants reaching the dose of 20 mg/d ) ( n = 15 ) or placebo ( n = 16 ) to their existing treatment for 8 weeks .
METHODS	The primary outcome , change in Montgomery-Asberg Depression Rating Score ( MADRS ) , was evaluated with repeated-measures mixed effects models using last-observation-carried-forward methods .
METHODS	Secondary outcomes included other depression and anxiety rating scales , suicidal and delusional ideation , and other adverse effects .
RESULTS	84 % of participants completed the trial , including 93 % of participants receiving memantine .
RESULTS	Participants receiving memantine did not show a statistically or clinically significant change in MADRS scores compared to placebo , either over the entire study ( = 0.133 , favoring placebo , P = .74 ) or at study completion ( week 8 mean [ SD ] MADRS score change = -7.13 [ 6.61 ] [ memantine ] ; -7.25 [ 11.14 ] [ placebo ] ; P = .97 ) .
RESULTS	A minimal to small effect size ( comparing change to baseline variability ) favoring placebo was observed ( Cohen d = 0.19 ) .
RESULTS	Similarly , no substantial effect sizes favoring memantine nor statistically significant between-group differences were observed on secondary efficacy outcomes .
CONCLUSIONS	This trial did not detect significant statistical or effect size differences between memantine and placebo augmentation among nonresponders or poor responders to conventional antidepressants .
CONCLUSIONS	While the small number of participants is a limitation , this study suggests memantine lacks substantial efficacy as an augmentation treatment for major depressive disorder .
BACKGROUND	ClinicalTrials.gov identifier : NCT00344682 .

###24434827
BACKGROUND	Evidence supports the role of feedback in reinforcing motivation for behavior change .
BACKGROUND	Feedback that provides reinforcement has the potential to increase dietary self-monitoring and enhance attainment of recommended dietary intake .
OBJECTIVE	The aim of this study was to examine the impact of daily feedback ( DFB ) messages , delivered remotely , on changes in dietary intake .
METHODS	This was a secondary analysis of the Self - Monitoring And Recording using Technology ( SMART ) Trial , a single-center , 24-month randomized clinical trial of behavioral treatment for weight loss .
METHODS	Participants included 210 obese adults ( mean body mass index , 34.0 kg/m ) who were randomized to either a paper diary ( PD ) , personal digital assistant ( PDA ) , or PDA plus daily tailored feedback messages ( PDA + FB ) .
METHODS	To determine the role of daily tailored feedback in dietary intake , we compared the self-monitoring with DFB group ( DFB group ; n = 70 ) with the self-monitoring without DFB group ( no-DFB group , n = 140 ) .
METHODS	All participants received a standard behavioral intervention for weight loss .
METHODS	Self-reported changes in dietary intake were compared between the DFB and no-DFB groups and were measured at baseline and at 6 , 12 , 18 , and 24 months .
METHODS	Linear mixed modeling was used to examine percentage changes in dietary intake from baseline .
RESULTS	Compared with the no-DFB group , the DFB group achieved a larger reduction in energy ( -22.8 % vs -14.0 % ; P = .02 ) and saturated fat ( -11.3 % vs -0.5 % ; P = .03 ) intake and a trend toward a greater decrease in total fat intake ( -10.4 % vs -4.7 % ; P = .09 ) .
RESULTS	There were significant improvements over time in carbohydrate intake and total fat intake for both groups ( P values < .05 ) .
CONCLUSIONS	Daily tailored feedback messages designed to target energy and fat intake and delivered remotely in real time using mobile devices may play an important role in the reduction of energy and fat intake .

###25424299
OBJECTIVE	To investigate the accelerating effects of low-intensity pulse ultrasound stimulation ( LIPUS ) on the fracture healing of distal radius .
METHODS	A total of 81 patients with distal radius fracture were randomly divided into two groups : the ultrasound treatment group and the control group .
METHODS	Patients in the ultrasound treatment group were immobilized in a below-elbow cast and received LIPUS treatment 15 min/day , while the control group were immobilized by a plaster support and cast .
METHODS	The patients were followed up every week and took X-ray films .
METHODS	The initial and healed X-ray films and the gray value of fracture site were analyzed by Photoshop software .
METHODS	The effect of reposition was evaluated based upon Steward recommended by Dienst , combining with Aro 's measuring method .
RESULTS	Clinical fracture healing time in ultrasound group was significantly shorter than that in the control group ( 32.04 2.58 d vs. 40.75 5.12 d , p < 0.01 ) .
RESULTS	In addition , the grey value changes of fracture sites of the ultrasound group were much higher than that of the control group .
RESULTS	The reposition effects of fracture healing had no difference between the two groups ( p > 0.05 ) .
CONCLUSIONS	Low-intensity pulse ultrasound stimulation could accelerate fracture healing of the distal radius and promote local bone formation .

###25390874
OBJECTIVE	To determine whether clinical findings-bleeding on probing , pocket depth , recession , and bacterial sampling-correlate with histologic outcomes in relatively healthy peri-implant soft tissues in people .
METHODS	In this cross-sectional study , a convenience sample of 20 edentulous subjects received two endosseous mandibular implants each .
METHODS	The abutments were either zirconia ( ZrO ) or titanium ( Ti ) ( nonsubmerged implant placement , within-subject comparison , leftright randomization ) .
METHODS	Sulcular bacterial sampling and assessment of probing pocket depth , recession , and bleeding on probing were performed 3 months postsurgery .
METHODS	Mucosal biopsy specimens were obtained , and the blood vessel density and a score on an inflammation grading scale were determined .
RESULTS	Simple linear and linear regression models revealed that the clinical or microbiologic parameters were not associated with either of the histologic parameters .
RESULTS	The soft tissues impressed as healthy , regardless of the abutment material .
CONCLUSIONS	The peri-implant mucosa around ZrOand Ti abutments was considered healthy in most situations when examined histologically after 3 months but showed variation in clinical and microbiologic parameters .

###25129282
BACKGROUND	Exercise prescription in cardiac patients is based on heart rate ( HR ) response to exercise .
BACKGROUND	How to prescribe long-term exercise training outside medically-supervised settings also considering changes in individual physical capacity over time is unknown .
BACKGROUND	In this study we hypothesized that in patients with chronic heart failure ( CHF ) the session-rate of perceived exertion ( RPE ) , a subjective-based training methodology , provides autonomic and functional capacity changes superimposable to those observed with HR-based Training Impulses ( TRIMPi ) method .
METHODS	Twenty patients with stable CHF were randomized to either aerobic continuous training ( ACT ) or aerobic interval training ( AIT ) for 12 weeks .
METHODS	For each TRIMPi-guided exercise session , the session-RPE was recorded .
METHODS	By this method , internal training load ( TL ) is quantified by multiplying the RPE of the whole training session , using the Borg CR10-scale , by its duration .
METHODS	Heart rate variability ( HRV ) , and baroreflex sensitivity ( BRS ) were assessed at baseline and at 3 weeks intervals .
RESULTS	Significant correlations were found between TRIMPi and individual session-RPE , for both ACT and AIT ( r = 0.63 to 0.81 ) , ( P < 0.05 ) .
RESULTS	The same occurred when ACT and AIT groups were pooled together ( r = 0.72 ; P < 0.01 ) .
RESULTS	R-R interval , HRV and BRS were significantly and very highly correlated with weekly RPE-session ( r ( 2 ) ranged from 0.77 to 0.97 ; P < 0.001 ) .
RESULTS	A significant relationship between session-RPE and performance at the 6MWT was also found .
CONCLUSIONS	Session-RPE is an easy-to-use , inexpensive and valid method for exercise prescription and health maintenance , consistent with objective physiological indices of training , that could be used for long-term physical activity in patients with CHF .

###25788001
BACKGROUND	Epidemiologic data suggest inverse associations between citrus flavanone intake and cardiovascular disease ( CVD ) risk .
BACKGROUND	However , insufficient randomized controlled trial data limit our understanding of the mechanisms by which flavanones and their metabolites potentially reduce cardiovascular risk factors .
OBJECTIVE	We examined the effects of orange juice or a dose-matched hesperidin supplement on plasma concentrations of established and novel flavanone metabolites and their effects on cardiovascular risk biomarkers in men at moderate CVD risk .
METHODS	In an acute , randomized , placebo-controlled crossover trial , 16 fasted participants ( aged 51-69 y ) received orange juice or a hesperidin supplement ( both providing 320 mg hesperidin ) or control ( all matched for sugar and vitamin C content ) .
METHODS	At baseline and 5 h postintake , endothelial function ( primary outcome ) , blood pressure , arterial stiffness , cardiac autonomic function , platelet activation , and NADPH oxidase gene expression and plasma flavanone metabolites were assessed .
METHODS	Before each intervention , a diet low in flavonoids , nitrate/nitrite , alcohol , and caffeine was followed , and a standardized low-flavonoid evening meal was consumed .
RESULTS	Orange juice intake significantly elevated mean SEM plasma concentrations of 8 flavanone ( 1.75 0.35 mol/L , P < 0.0001 ) and 15 phenolic ( 13.27 2.22 mol/L , P < 0.0001 ) metabolites compared with control at 5 h postconsumption .
RESULTS	Despite increased plasma flavanone and phenolic metabolite concentrations , cardiovascular risk biomarkers were unaltered .
RESULTS	After hesperidin supplement intake , flavanone metabolites were not different from the control , suggesting altered absorption/metabolism compared with the orange juice matrix .
CONCLUSIONS	After single-dose flavanone intake within orange juice , circulating flavanone and phenolic metabolites collectively reached a concentration of 15.20 2.15 mol/L , but no effects were observed on cardiovascular risk biomarkers .
CONCLUSIONS	Longer-duration randomized controlled trials are required to examine previous associations between higher flavanone intakes and improved cardiovascular health and to ascertain the relative importance of food matrix and flavanone-derived phenolic metabolites .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01530893 .

###24268208
BACKGROUND	Incomplete revascularization ( ICR ) after percutaneous coronary intervention ( PCI ) is common and is associated with increased rates of rehospitalization , revascularization , and mortality .
BACKGROUND	Adjunctive pharmacotherapy with ranolazine , an inhibitor of the late sodium current with anti-ischemic properties , may be effective in reducing recurrent events after PCI in patients with ICR .
METHODS	RIVER-PCI is a phase 3 , randomized , double-blind , placebo-controlled , international event-driven clinical trial evaluating the efficacy of ranolazine in patients with a history of chronic angina and ICR after PCI .
METHODS	Approximately 2,600 participants with ICR post-PCI will be randomized in a 1:1 ratio to ranolazine or matched placebo within 14 days of an index PCI .
METHODS	The primary end point of the trial is time to the first occurrence of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization .
METHODS	Participants will be followed up for a minimum of 1 year and until at least 720 confirmed primary end point events have occurred .
METHODS	Secondary end points include sudden cardiac death , cardiovascular death , myocardial infarction , and measures of quality of life and cost-effectiveness .
METHODS	The evaluation of long-term safety will include all-cause mortality , stroke , transient ischemic attack , and hospitalization for heart failure .
METHODS	Enrollment commenced in November 2011 and was completed in summer 2013 .
CONCLUSIONS	RIVER-PCI is a novel , large-scale , international , randomized , double-blind , placebo-controlled clinical trial evaluating the role of ranolazine in the long-term medical management of patients with ICR post-PCI .

###24373281
OBJECTIVE	postoperative pain increases the activity of the sympathetic system , causes hypermetabolic conditions , retains salt and water , increases glucose , fatty acid lactate and oxygen consumption , weakens the immunity system which delays wound healing .
OBJECTIVE	Our object was comparison of the analgesic effect of morphine and paracetamol in the patients undergoing laparotomy , using PCA method .
METHODS	Seventy patients who had undergone laparotomy were studied using double blind randomized clinical trial ( 35 patients received morphine and 35 paracetamol ) in the Shahid Rajaee Center and Velayat Hospital ( Qazvin , Iran ) .
METHODS	People using opioids , painkillers and sedatives regularly and in large doses and patients with a history of lung or liver problems did not participate in this project .
METHODS	The parameters of the severity of pain and nausea ( VAS ) , hemodynamic changes ( BP and HR ) , pruritus , arterial oxygen desaturation and patient satisfaction ( VAS ) of both groups were measured by a third party ( trained colleague ) .
METHODS	The data was analyzed using SPSS 16 statistical software then descriptive results were extracted and ultimately the groups were compared using the following statistical tests : student 's T-test , chi 2 and Fisher 's exact test ( P < 0.05 ) .
RESULTS	The mean age of the participants was 4512.5 years .
RESULTS	Women constituted 24.3 % of the patients and men 75.7 % .
RESULTS	The average pain severity for morphine and paracetamol groups ( VAS ) was 5.32.2 and 6.371.7 after2 hours and reached 1.911.3 and 2.491.3 after 8 hours ( after the operation ) respectively .
RESULTS	There was a significant difference between the groups after 2 and 4 hours in terms of pain severity ( after 2 hours P = 0.007 and after 4 hours P = 0.047 ) .
RESULTS	However there was no significant difference between the average pain severity of the studied groups ( after 6 hours P = 0.4 and 8 hours P = 0.08 ) .
RESULTS	After 8 hours , the average nausea severity was the minimum in both groups being 1.711.6 and 1.431.1 in morphine and paracetamol groups respectively .
RESULTS	Nausea severity was higher after 2 hours in paracetamol group .
RESULTS	In morphine group , it was higher after 4 , 6 and 8 hours .
RESULTS	Difference between the groups was not significant .
RESULTS	The average satisfaction level ( VAS ) for morphine and paracetamol groups reached from 5.292.3 and 4.22.4 after 2 hours , to 7.941.8 and 7.692.1 after 8 hours ( after the operation ) , respectively .
RESULTS	The average satisfaction level of patients was higher in morphine group in 2,4,6 and 8 hours and except for , after 4 hours ( P = 0.01 ) , the satisfaction difference between both groups was not significant in other hours ( P = 0.06 after 2 hours , P = 0.6 after 6 hours and P = 0.5 after 8 hours )
CONCLUSIONS	Morphine seems to be more effective at 2 and 4 hours , but after 4 hours they have similar effects , the satisfaction difference between both groups was not significant in the patients .

###25237670
OBJECTIVE	To compare the clinical outcome of platform switching ( PS ) and regular platform ( RP ) implants in bilateral single molar replacements .
METHODS	This study was designed as a randomised , controlled , split-mouth trial .
METHODS	Eighteen patients , with bilaterally missing single molars had one site randomly assigned to a PS implant or a RP implant .
METHODS	A total of 36 implants were bilaterally installed .
METHODS	Both implants were loaded with screw retained temporary crowns 3 months after implant insertion and with screw retained definitive crowns 3 months later .
METHODS	Outcome measures were implant/crown failure , complications , radiographic marginal bone-level changes , pocket probing depth ( PPD ) and bleeding on probing ( BOP ) .
METHODS	Clinical data were collected at baseline 6 and 12 months after implant placement .
RESULTS	No patients dropped out and no implant failed .
RESULTS	No prosthetic or major biological complications were observed .
RESULTS	One year after implant placement , mean marginal bone level was 0.93 0.26 mm ( 95 % CI 0.81 to 1.05 ) in RP group and 0.84 0.23 mm ( 95 % CI 0.73 to 0.95 ) in the PS group and no statistically significant differences between the two groups were observed ( P = 0.18 ) .
RESULTS	Mean PPD and BOP values were , 6 and 12 months after implant placement , 2.74 0.49 mm ( 95 % CI 2.51 to 2.97 ) and 1.28 0.75 ( 95 % CI 0.93 to 1.63 ) in the RP group , and 2.70 0.38 mm ( 95 % CI 2.53 to 2.88 ) and 1.39 0.78 ( 95 % CI 1.03 to 1.75 ) in the PS group respectively , with no statistical differences between groups ( P = 0.81 and P = 0.16 , respectively ) .
CONCLUSIONS	No statistically significant difference was observed between platform switched and non-platform switched implants .

###25304939
BACKGROUND	The use of structured curricula for minimally invasive surgery training is becoming increasingly popular .
BACKGROUND	However , many laparoscopic training programs still use basic skills and isolated task training , despite increasing evidence to support the use of training models with higher functional resemblance , such as whole procedural modules .
BACKGROUND	In contrast to basic skills training , procedural training involves several cognitive skills such as elements of planning , movement integration , and how to avoid adverse events .
BACKGROUND	The objective of this trial is to investigate the specificity of procedural practice in laparoscopic simulator training .
METHODS	A randomised single-centre educational superiority trial .
METHODS	Participants are 96 surgical novices ( medical students ) without prior laparoscopic experience .
METHODS	Participants start by practicing a series of basic skills tasks to a predefined proficiency level on a virtual reality laparoscopy simulator .
METHODS	Upon reaching proficiency , the participants are randomised to either the intervention group , which practices two procedures ( an appendectomy followed by a salpingectomy ) or to the control group , practicing only one procedure ( a salpingectomy ) on the simulator .
METHODS	1:1 central randomisation is used and participants are stratified by sex and time to complete the basic skills .
METHODS	Data collection is done at a surgical skills centre.The primary outcome is the number of repetitions required to reach a predefined proficiency level on the salpingectomy module .
METHODS	The secondary outcome is the total training time to proficiency .
METHODS	The improvement in motor skills and effect on cognitive load are also explored .
CONCLUSIONS	The results of this trial might provide new knowledge on how the technical part of surgical training curricula should be comprised in the future .
CONCLUSIONS	To examine the specificity of practice in procedural simulator training is of great importance in order to develop more comprehensive surgical curricula .
BACKGROUND	ClinicalTrials.gov : NCT02069951 .

###25451868
BACKGROUND	Although cardiac troponin is associated with outcomes in atrial fibrillation ( AF ) , the complementary prognostic information provided by cardiac troponin I ( cTnI ) and cTnT is unknown .
BACKGROUND	This study investigated the distribution , determinants , and prognostic value of cTnI and cTnT concentrations in patients with AF .
METHODS	Samples were collected .
METHODS	At the time of randomization , we analyzed cTnI and cTnT concentrations of 14806 AF patients in the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation ( ARISTOTLE ) trial using high-sensitivity assays .
METHODS	Correlations ( Spearman ) , determinants ( multivariable linear regression ) , and outcomes ( adjusted Cox models and c-statistics ) were investigated .
RESULTS	Concentrations of cTnI and cTnT were correlated ( r = 0.70 ) and measurable in most participants [ cTnI 98.5 % ( median 5.4 ng/L , 99th percentile in 9.2 % ) and cTnT 93.5 % ( median 10.9 ng/L , 99th percentile in 34.4 % ) ] .
RESULTS	Renal impairment was the most important factor affecting the concentrations of both troponins .
RESULTS	cTnI increase was more associated with heart failure , vascular disease , and persistent/permanent AF , and cTnT with age , male sex , and diabetes .
RESULTS	Over a median 1.9 years of follow-up , patients with both troponins above the median had significantly higher risk for stroke/systemic embolism [ hazard ratio ( HR ) 1.72 ( 95 % CI 1.31-2 .27 ) ] , cardiac death [ 3.14 ( 2.35-4 .20 ) ] , and myocardial infarction [ 2.99 ( 1.78-5 .03 ) ] than those with both troponins below median ( all P < 0.005 ) .
RESULTS	Intermediate risks were observed when only 1 troponin was above the median .
RESULTS	When combined with clinical information , each marker provided similar prognostication and had comparable c-index .
CONCLUSIONS	cTnI and cTnT concentrations are moderately correlated and measurable in plasma of most AF patients .
CONCLUSIONS	The risk of stroke and cardiovascular events is highest when both troponins are above median concentrations .
CONCLUSIONS	Each troponin provides comparable prognostic information when combined with clinical risk factors .
CONCLUSIONS	ClinicalTrials.gov / NCT00412984 .

###25837184
OBJECTIVE	The aim of this study was to evaluate the effects and safety of a sleep aid for postoperative analgesia in patients undergoing arthroscopic rotator cuff repair .
METHODS	Seventy-eight patients were prospectively assigned to either the zolpidem group ( multimodal analgesia + zolpidem ; 39 patients ) or the control group ( multimodal analgesia ; 39 patients ) .
METHODS	Self-rated pain levels were assessed twice a day using a visual analog scale ( VAS ) .
METHODS	The need for additional rescue analgesic , duration of functional recovery , and adverse effects were assessed for the first 5 days after surgery .
RESULTS	The mean number of times that additional rescue analgesic was required during 5 days after surgery was 2.12.0 in the zolpidem group and 3.32.8 in the control group , a significant difference .
RESULTS	There were no significant differences between the two groups in mean VAS pain scores during the first 5 days after surgery , although the zolpidem group had lower VAS pain scores than the control group .
RESULTS	Additionally , there were no significant differences in duration of functional recovery and adverse effects between the two groups .
CONCLUSIONS	The use of zolpidem for analgesia after arthroscopic rotator cuff repair provided a significant reduction in the need for rescue analgesic without increasing adverse effects .
CONCLUSIONS	Nevertheless , mean VAS pain scores during the first 5 days after surgery did not differ between the zolpidem group and the control group .

###24638013
OBJECTIVE	Surgical resection plus adjuvant platinum-based chemotherapy is considered standard care for stage II to III non-small-cell lung cancer ( NSCLC ) , but its efficacy is limited , and it involves toxic risks , justifying patient-tailored treatment .
OBJECTIVE	Excision repair cross-complementation group 1 ( ERCC1 ) was shown to predict cisplatin-based chemotherapy response ; EGFR mutations were predictive of epidermal growth factor receptor inhibition response .
METHODS	This prospective randomized phase II trial enrolled 150 patients with completely resected non-squamous cell stage II or IIIA ( non-N2 ) tumors .
METHODS	Patients in the control arm ( n = 74 ) were treated with four standard-dose courses of cisplatin plus pemetrexed ( CP ) .
METHODS	In the customized treatment arm ( n = 76 ) , patients with activated EGFR mutations received erlotinib 150 mg for 1 year ; ERCC1-negative patients received four CP courses , whereas ERCC1-positive patients underwent follow-up .
METHODS	The trial sought to demonstrate the feasibility of customized adjuvant chemotherapy based on timely biomarker analysis within a 2-month postsurgery delay .
METHODS	Secondary objectives were tolerability , compliance with adjuvant therapy , and biomarker distribution .
RESULTS	In arm A , all patients received CP ; in arm B , seven received erlotinib , 53 were administered CP , and 16 underwent follow-up .
RESULTS	Median erlotinib exposure was 344 days .
RESULTS	Of the 127 patients allocated to CP , 82 % received four cycles with good tolerability .
RESULTS	The overall success rate of the trial ( ie , percentage of patients with complete biomarker status able to start adjuvant treatment within 2 months of surgery ) was 80 % .
CONCLUSIONS	The primary end point of the trial was met , demonstrating the feasibility of a national biology-driven trial in the adjuvant NSCLC setting .
CONCLUSIONS	Nevertheless , the phase III part was canceled because of the unreliability of the ERCC1 immunohistochemical readouts .

###24419925
BACKGROUND	The phosphodiesterase inhibitors are used in the treatment of ED and there are increasing data of effects of these drugs on bladder and urethral relaxation as well as of prostatic smooth muscles that may relief the symptoms of BPH .
BACKGROUND	This study was conducted to evaluate the role of Tadalafil ( a PDE-5 inhibitor ) in combination with standard therapy for the treatment of BPH .
METHODS	In this randomized clinical trial of 165 patients with obstructive and irritative urinary tract symptoms due to BPH , IPSS 8 , Iief 11 , Q-max from 5 mL/s to 15 mL/s and residual urine volume ( RUV ) < 120 mL , there was indication for surgical intervention .
METHODS	These patients were randomly allocated in three groups .
METHODS	Each patient received a therapeutic treatment daily for 12 weeks .
METHODS	Group A received treatment with tamsulosin 0.4 mg and tadalafil 5 mg , Group B received a standard treatment with tamsulosin 0.4 mg for BPH and Group C received only one treatment with tadalafil 5 mg .
RESULTS	There was no significant difference in terms of IPSS score , Qmax and RUV before treatment in the three groups tested .
RESULTS	Analysis of the data shows that in patients treated with tamsulosin and tadalafil IPSS , IIEF and QoL were significantly improved in a different way than in the other two groups , while the Qmax and RUV did not show a significant change in the three groups , remaining almost constant .
CONCLUSIONS	The PDE-5 inhibitor improves quality of life and urinary symptoms in patients with LUTS suggestive of BPH , but does n't have any significant effect on Qmax and RUV .

###25518099
BACKGROUND	This article presents the results of research based on the feelings and responses of members of a sports club , in relation to a fitness programme offered by Fitness World .
METHODS	The study consisted of a group of 58 participants chosen at random .
METHODS	Statistically , the analysed results of the research show that the biggest group attending Fitness World consists of men between 31 and 50 years of age with higher education , and women between 18 and 30 with , mostly , higher education .
METHODS	In general , men prefer to participate in aerobics group sessions and gym sessions , and women choose to take part in any activities .
CONCLUSIONS	The most preferred time was between 5 p.m. and 10 p.m. , usually after work , and with a frequency of twice a week .
CONCLUSIONS	It was not possible to determine the main reasons for motivation , although 93 % prefer to practise regularly .

###24471247
OBJECTIVE	To generate comparative clinical data in Indian patients with acute coronary syndrome ( ACS ) in terms of safety and efficacy of atorvastatin 80 mg vis -- vis atorvastatin 40 mg
METHODS	A total of 236 patients with diagnosed ACS ( with TIMI Risk score > or = 3 ) within preceding 10 days were randomized to receive either atorvastatin 80 mg or atorvastatin 40 mg once daily for 12 weeks .
METHODS	Out of 236 patients , data for 173 was analyzed who had both baseline and post-baseline lipid assessment .
METHODS	The primary end point of the trial was percentage change in LDL-C at the end of treatment from baseline .
METHODS	Other end points were change in high sensitivity C reactive protein , incidence of increase in liver enzymes > or = 3 times upper limit of normal and incidence of myotoxicity ( with or without elevation of creatinine phosphokinase ) at the end of treatment .
RESULTS	A dose-dependent response was observed with greater reduction of LDL - C in atorvastatin 80 mg ( 27.5 % vs 19.04 % ) than that of atorvastatin 40 mg group .
RESULTS	Both the treatment groups had a significant reduction ( p < 0.001 ) in LDL-C at the end of 6 and 12 weeks in comparison to baseline .
RESULTS	hs-CRP was also significantly reduced ( p < 0.001 ) in both the treatment groups i.e. atorvastatin 80 mg ( 76.15 % ) and atorvastatin 40 mg ( 84.4 % ) from baseline at the end of 12 weeks .
RESULTS	Both doses of atorvastatin were well tolerated .
RESULTS	No patient had elevation of ( > or = 3 times of upper limit of normal ) liver enzymes or creatinine phosphokinase .
RESULTS	One patient on atorvastatin 80 mg complained of myalgia .
RESULTS	There were no dose-related differences in incidence of adverse events between two treatment groups .
CONCLUSIONS	The CURE-ACS trial indicated that atorvastatin 80 mg was more effective than atorvastatin 40 mg in terms of reduction in LDL cholesterol and was as safe and well tolerated as 40 mg dose in Indian patients with ACS .

###24390682
BACKGROUND	With high-fidelity simulators in a modern blended learning setting , students are able to acquire knowledge and practical skills in acute medicine in realistic scenarios .
BACKGROUND	However , it has not yet been clarified if the sequence of linking between knowledge and simulator-based training of practical skills plays an important role for increasing knowledge , for the self-concept and learning emotions of trainees .
OBJECTIVE	In a pilot study the influence of the type of knowledge acquisition under two independent conditions was investigated in which the order of presenting the learning material ( firstly theory and then simulation vs. simulation elements before the theory ) was reversed .
OBJECTIVE	In addition the influence of individual attributes of personality on the construction of situated knowledge was correlated with these conditions in two groups .
METHODS	To investigate the outcome of simulator-based learning 20 students were randomly allocated to one of the two conditions and undertook two scenarios ( anaphylactic shock and myocardial infarction ) , whereby the theoretical lessons were given either before or after the scenarios .
METHODS	Using standardized questionnaires and problem-centered semi-standardized interviews , the following variables of the participants were assessed : personality traits , current positive and negative feelings , professional self-concept , general self-efficacy and coping strategies for stress .
METHODS	Theoretical knowledge and practical skills were assessed using a knowledge test and standardized assessment questionnaires which also focused on performance and patient safety .
RESULTS	All together the results showed a slight advantage for the condition of theory before simulation which was not determined by the acquisition of knowledge but by a better performance of trainees as assessed by the trainers .
RESULTS	Regarding knowledge acquisition , no statistically significant differences could be shown .
RESULTS	Significant differences ( p < 0.05 ) were found for negative feelings ( very intense negative emotional state ) and for the professional self-concept ( perception of own professional skills ) in favor of the theory then simulation condition .
RESULTS	More extrovert participants showed poorer results which could not be attributed to one of the conditions .
RESULTS	However , the participants always assessed the allocated learning condition as the best premise for effective learning outcome .
RESULTS	Reaction to stress has been described as `` jumping in at the deep end '' as well as the lasting effect on learning from errors .
CONCLUSIONS	In the context of simulation-based teaching , the learning outcome not only depends on knowledge , practical skills and motivational variables but also on the presence of negative feelings , ability self-concepts and various personality traits .
CONCLUSIONS	There was a trend which showed that simulation in the field of anesthesiology and emergency medicine should be set up with the theoretical basis first in order to avoid negative feelings .

###25299350
OBJECTIVE	To evaluate the relative efficacy and safety of extended-release tramadol HCl 75mg/acetaminophen 650mg ( TA-ER ) and immediate-release tramadol HCl 37.5 mg/acetaminophen 325mg ( TA-IR ) for the treatment of moderate to severe acute pain following total knee replacement .
METHODS	This phase III , double-blind , placebo-controlled , parallel-group study randomized 320 patients with moderate to severe pain ( 4 intensity on an 11 point numeric rating scale ) following total knee replacement arthroplasty to receive oral TA-ER ( every 12 hours ) or TA-IR ( every 6 hours ) over a period of 48 hours .
METHODS	In the primary analysis , TA-ER was evaluated for efficacy non-inferior to that of TA-IR based on the sum of pain intensity difference ( SPID ) at 48 hours after the first dose of study drug ( SPID48 ) .
METHODS	Secondary endpoints included SPID at additional time points , total pain relief at all on-therapy time points ( TOTPAR ) , sum of SPID and TOTPAR at all on-therapy time points ( SPID+TOTPAR ) , use of rescue medication , subjective pain assessment ( PGIC , Patient Global Impression of Change ) , and adverse events ( AEs ) .
RESULTS	Analysis of the primary efficacy endpoint ( SPID48 ) could not establish the non-inferiority of TA-ER to TA-IR .
RESULTS	However , a post hoc analysis with a re-defined non-inferiority margin did demonstrate the non-inferiority of TA-ER to TA-IR .
RESULTS	No statistically significant difference in SPID at 6 , 12 , or 24 hours was observed between the TA-ER and TA-IR groups .
RESULTS	Similarly , analysis of TOTPAR showed that there were no significant differences between groups at any on-therapy time point , and SPID+TOTPAR at 6 and 48 hours were similar among groups .
RESULTS	There was no difference in the mean frequency or dosage of rescue medication required by both groups , and the majority of patients in both the TA-ER and TA-IR groups rated their pain improvement as ` much ' or ` somewhat better ' .
RESULTS	The overall incidence of 1 AEs was similar among the TA-ER ( 88.8 % ) and TA-IR ( 89.5 % ) groups .
RESULTS	The most commonly reported AEs by patients treated with TA-ER and TA-IR included nausea ( 49.7 % vs 44.4 % ) , vomiting ( 28.0 % vs 24.2 % ) , and decreased hemoglobin ( 23.6 % vs 26.1 % ) .
RESULTS	This study is limited by the lack of placebo control , and the invalidity of the initial non-inferiority margin .
CONCLUSIONS	This study demonstrated that the analgesic effect of TA-ER is non-inferior to TA-IR , and supports TA-ER as an effective and safe treatment for moderate to severe acute pain post total knee replacement .
BACKGROUND	Clinicaltrials.gov , NCT01814878 .

###25946554
OBJECTIVE	Methotrexate is a first-line systemic agent for treating of psoriasis , although its onset of effects is slower and overall it is less effective than tumor necrosis factor blockers .
OBJECTIVE	To differentiate the response of psoriatic disease to adalimumab and methotrexate sodium .
METHODS	Single-center , randomized , assessor-blind , 2-arm clinical trial of 30 patients from the outpatient dermatology center of Tufts Medical Center , enrolled from August 18 , 2009 , to October 11 , 2011 .
METHODS	Patients aged 18 to 85 years with chronic plaque-type psoriasis , a minimum Physician Global Assessment score of 3 ( higher scores indicate more severe disease ) , and a psoriatic plaque of at least 2 cm were randomized in a 1:1 fashion to receive subcutaneous adalimumab or oral methotrexate .
METHODS	Skin biopsy specimens obtained at baseline and weeks 1 , 2 , 4 , and 16 were given a histologic grade by blinded assessors to evaluate treatment response .
METHODS	Analyses were conducted from April 16 , 2013 , to January 5 , 2015 .
METHODS	A 16-week course of subcutaneous adalimumab ( 40 mg every 2 weeks after a loading dose ) or low-dosage oral methotrexate sodium ( 7.5-25 mg/wk ) .
METHODS	Changes in genomic , immunohistochemical , and messenger RNA ( mRNA ) profiles .
RESULTS	Methotrexate responders experienced significant downregulation of helper T-cell-related ( T ( H ) 1 , T ( H ) 17 , and T ( H ) 22 ) mRNA expression compared with methotrexate nonresponders .
RESULTS	Comparisons among adalimumab-treated patients were limited by the number of nonresponders ( n = 1 ) .
RESULTS	Between adalimumab and methotrexate responders , we found no significant differences in gene expression at any study point or in the expression of T-cell-related mRNA at week 16 .
RESULTS	Adalimumab responders demonstrated early downregulation of chemokine ( C-C motif ) ligand 20 ( CCL20 ) mRNA ( mean [ SE ] at week 2 , -1.83 [ 0.52 ] , P < .001 ; week 16 , -3.55 [ 0.54 ] , P < .001 ) compared with late downregulation for methotrexate responders ( week 2 , 0.02 [ 0.51 ] , P = .96 ; week 16 , -2.96 [ 0.51 ] , P < .001 ) .
RESULTS	Similar differences were observed with interleukin 22 ( IL22 ) mRNA showing early downregulation for adalimumab responders ( week 2 , -3.17 [ 1.00 ] , P < .001 ; week 16 , -3.58 [ 1.00 ] , P < .001 ) compared with late downregulation for methotrexate responders ( week 2 , -0.44 [ 0.68 ] , P = .64 ; week 16 , -5.14 [ 0.68 ] , P < .001 ) .
RESULTS	Analysis of variance findings for key mRNA and immunohistochemical marker expression over the study course were significant only for CCL20 ( P = .03 ) and IL22 ( P = .006 ) mRNA comparing adalimumab and methotrexate responders .
CONCLUSIONS	Methotrexate is an immunomodulator with effects on helper T-cell signaling in psoriasis .
CONCLUSIONS	Similar genomic and immunohistochemical response signatures and levels of mRNA downregulation at study completion among adalimumab and methotrexate responders suggest a disease-driven instead of therapeutic-driven pathway regulation .
CONCLUSIONS	Adalimumab and methotrexate responses are differentiated by patterns of normalization of CCL20 and IL22 mRNA expression and may explain the varied onset and degree of clinical responses by each treatment .
BACKGROUND	clinicaltrials.gov Identifier : NCT00932113 .

###25823791
OBJECTIVE	The need to prevent reflux in the construction of an orthotopic ileal neobladder is controversial .
OBJECTIVE	We designed the USC-STAR trial to determine whether the T-pouch neobladder that included an antireflux mechanism was superior to the Studer pouch in patients with bladder cancer undergoing radical cystectomy .
METHODS	This single center , randomized , controlled trial recruited patients with clinically nonmetastatic bladder cancer scheduled to undergo radical cystectomy with neobladder .
METHODS	Eligible patients were randomly assigned to undergo T-pouch or Studer ileal orthotopic neobladder .
METHODS	Treatment assignment was not masked .
METHODS	The primary end point was change in renal function from baseline to 3 years .
METHODS	The CKD-EPI ( Chronic Kidney Disease Epidemiology Collaboration ) equation was used to calculate the estimated glomerular filtration rate .
RESULTS	Between February 2002 and November 2009 , 237 patients were randomly assigned to T-pouch ileal orthotopic neobladder and 247 to Studer ileal orthotopic neobladder .
RESULTS	Baseline characteristics did not differ between the groups .
RESULTS	Between baseline and 3 years the estimated glomerular filtration rate decreased by 6.4 ml/minute/1 .73 m ( 2 ) in the Studer group and 6.6 ml/minute/1 .73 m ( 2 ) in the T-pouch group ( p = 0.35 ) .
RESULTS	Multivariable analysis showed that type of ileal orthotopic neobladder was not independently associated with 3-year renal function ( p = 0.63 ) .
RESULTS	However , baseline estimated glomerular filtration rate , age and urinary tract obstruction were independently associated with 3-year decline in renal function .
RESULTS	Cumulative risk of urinary tract infection and overall late complications were not different between the groups , but the T-pouch was associated with an increased risk of secondary diversion related surgeries .
CONCLUSIONS	T-pouch ileal orthotopic neobladder with an antireflux mechanism did not prevent a moderate reduction in renal function observed at 3 years compared to the Studer pouch , but did result in an increase in diversion related secondary surgical procedures .

###24857264
OBJECTIVE	Facial affect recognition , a basic building block of social cognition , is often impaired in schizophrenia .
OBJECTIVE	Poor facial affect recognition is closely related to poor functional outcome ; however , neither social cognitive impairments nor functional outcome are sufficiently improved by antipsychotic drug treatment alone .
OBJECTIVE	Adjunctive repetitive transcranial magnetic stimulation ( rTMS ) has been shown to enhance cognitive functioning in both healthy individuals and in people with neuropsychiatric disorders and to ameliorate clinical symptoms in psychiatric disorders , but its effects on social cognitive impairments in schizophrenia have not yet been studied .
OBJECTIVE	Therefore , we evaluated the effects of sham-controlled rTMS on facial affect recognition in patients with chronic schizophrenia .
METHODS	Inpatients ( N = 36 ) on stable antipsychotic treatment were randomly assigned to double-blind high-frequency ( 10 Hz ) rTMS or sham stimulation for a total of ten sessions over two weeks .
METHODS	In the verum group , each session consisted of 10 000 stimuli ( 20 trains of 5 s ) applied over the left dorsolateral prefrontal cortex at 110 % of motor threshold .
METHODS	Facial affect recognition was assessed before ( T0 ) and after ( T1 ) the ten sessions .
RESULTS	Facial affect recognition improved significantly more after rTMS ( accuracy change : mean = 8.9 % , SD = 6.0 % ) than after sham stimulation ( mean = 1.6 % , SD = 3.5 ; Cohen 's d = 1.45 ) .
RESULTS	There was no correlation with clinical improvement .
CONCLUSIONS	Our results indicate that prefrontal 10 Hz rTMS stimulation may help to ameliorate impaired facial affect recognition in schizophrenia .

###26422722
BACKGROUND	Early clinical studies suggested that the anti-interleukin-17 receptor A monoclonal antibody brodalumab has efficacy in the treatment of psoriasis .
METHODS	In two phase 3 studies ( AMAGINE-2 and AMAGINE-3 ) , patients with moderate-to-severe psoriasis were randomly assigned to receive brodalumab ( 210 mg or 140 mg every 2 weeks ) , ustekinumab ( 45 mg for patients with a body weight 100 kg and 90 mg for patients > 100 kg ) , or placebo .
METHODS	At week 12 , patients receiving brodalumab were randomly assigned again to receive a brodalumab maintenance dose of 210 mg every 2 weeks or 140 mg every 2 weeks , every 4 weeks , or every 8 weeks ; patients receiving ustekinumab continued to receive ustekinumab every 12 weeks , and patients receiving placebo received 210 mg of brodalumab every 2 weeks .
METHODS	The primary aims were to evaluate the superiority of brodalumab over placebo at week 12 with respect to at least a 75 % reduction in the psoriasis area-and-severity index score ( PASI 75 ) and a static physician 's global assessment ( sPGA ) score of 0 or 1 ( clear or almost clear skin ) , as well as the superiority of brodalumab over ustekinumab at week 12 with respect to a 100 % reduction in PASI score ( PASI 100 ) .
RESULTS	At week 12 , the PASI 75 response rates were higher with brodalumab at the 210-mg and 140-mg doses than with placebo ( 86 % and 67 % , respectively , vs. 8 % [ AMAGINE-2 ] and 85 % and 69 % , respectively , vs. 6 % [ AMAGINE-3 ] ; P < 0.001 ) ; the rates of sPGA scores of 0 or 1 were also higher with brodalumab ( P < 0.001 ) .
RESULTS	The week 12 PASI 100 response rates were significantly higher with 210 mg of brodalumab than with ustekinumab ( 44 % vs. 22 % [ AMAGINE-2 ] and 37 % vs. 19 % [ AMAGINE-3 ] , P < 0.001 ) .
RESULTS	The PASI 100 response rates with 140 mg of brodalumab were 26 % in AMAGINE-2 ( P = 0.08 for the comparison with ustekinumab ) and 27 % in AMAGINE-3 ( P = 0.007 ) .
RESULTS	Rates of neutropenia were higher with brodalumab and with ustekinumab than with placebo .
RESULTS	Mild or moderate candida infections were more frequent with brodalumab than with ustekinumab or placebo .
RESULTS	Through week 52 , the rates of serious infectious episodes were 1.0 ( AMAGINE-2 ) and 1.3 ( AMAGINE-3 ) per 100 patient-years of exposure to brodalumab .
CONCLUSIONS	Brodalumab treatment resulted in significant clinical improvements in patients with moderate-to-severe psoriasis .
CONCLUSIONS	( Funded by Amgen ; AMAGINE-2 and AMAGINE-3 ClinicalTrials.gov numbers , NCT01708603 and NCT01708629 . )

###24263123
BACKGROUND	The significance of basal renal nitric oxide ( NO ) availability in the regulation of renal perfusion and sodium excretion in human congestive heart failure ( CHF ) has not been described previously .
RESULTS	We studied the effects of acute systemic NO synthesis inhibition with N ( G ) - monomethyl-L-arginine ( L-NMMA ) in 12 patients with CHF and 10 healthy control subjects ( CON ) in a randomized placebo-controlled study .
RESULTS	Effect parameters were renal plasma flow ( RPF ) , renal vascular resistance ( RVR ) , glomerular filtration rate ( GFR ) , urine sodium excretion and plasma levels of vasoactive hormones .
RESULTS	L-NMMA was associated with a significant decrease in RPF ( CON-LNMMA : -13 3 % [ P = .014 ] ; CHF-LNMMA : -17 7 % [ P = .017 ] ) and a profound increase in RVR in both CHF and CON ( CON-LNMMA : +26 6 % [ P = .009 ] ; CHF-LNMMA : +37 70 % [ P = .005 ] ) .
RESULTS	Significant decreases in sodium excretion were found in both CHF-LNMMA and CON-LNMMA .
RESULTS	Relative changes from baseline were not statistically different between CHF-LNMMA and CON-LNMMA .
RESULTS	After L-NMMA , RPF values correlated inversely with plasma aldosterone in CHF-LNMMA ( P = .01 ) .
RESULTS	L-NMMA induced an increase in A-type natriuretic peptide ( ANP ) only in CHF-LNMMA ( +18 8 % ; P = .035 ) , which correlated significantly with basal ANP levels ( P = .034 ) .
CONCLUSIONS	There was no difference in the renal response to L-NMMA in CHF vs CON , suggesting that the impact of NO on renal perfusion and sodium excretion is maintained in stable CHF .
CONCLUSIONS	We suggest that NO influences the release of ANP during high levels of atrial stretch in CHF .

###24952864
OBJECTIVE	Adipose-derived regenerative cells ( ADRCs ) can be isolated from liposuction aspirates and prepared as fresh cells for immediate administration in cell therapy .
OBJECTIVE	We performed the first randomized , placebo-controlled , double-blind trial to examine the safety and feasibility of the transendocardial injections of ADRCs in no-option patients with ischemic cardiomyopathy .
RESULTS	Procedural , postoperative , and follow-up safety end points were monitored up to 36 months .
RESULTS	After baseline measurements , efficacy was assessed by echocardiography and single-photon emission computed tomography ( 6 , 12 , and 18 months ) , metabolic equivalents and maximal oxygen consumption ( MVO2 ) ( 6 and 18 months ) , and cardiac magnetic resonance imaging ( 6 months ) .
RESULTS	We enrolled 21 ADRC-treated and 6 control patients .
RESULTS	Liposuction was well tolerated , ADRCs were successfully prepared , and transendocardial injections were feasible in all patients .
RESULTS	No malignant arrhythmias were seen .
RESULTS	Adverse events were similar between groups .
RESULTS	Metabolic equivalents and MVO2 values were preserved over time in ADRC-treated patients but declined significantly in the control group .
RESULTS	The difference in the change in MVO2 from baseline to 6 and 18 months was significantly better in ADRC-treated patients compared with controls .
RESULTS	The ADRC-treated patients showed significant improvements in total left ventricular mass by magnetic resonance imaging and wall motion score index .
RESULTS	Single-photon emission computed tomography results suggested a reduction in inducible ischemia in ADRC-treated patients up to 18 months .
CONCLUSIONS	Isolation and transendocardial injection of autologous ADRCs in no-option patients were safe and feasible .
CONCLUSIONS	Our results suggest that ADRCs may preserve ventricular function , myocardial perfusion , and exercise capacity in these patients .

###25142075
BACKGROUND	The treatment of cancer patients with mistletoe extract is said to prolong their survival and , above all , improve their quality of life .
BACKGROUND	We studied whether the quality of life of patients with advanced pancreatic cancer could be improved by mistletoe extract .
METHODS	An open , single-center , group-sequential , randomized phase III trial ( ISRCTN70760582 ) was conducted .
METHODS	From January 2009 to December 2010 , 220 patients with locally advanced or metastatic pancreatic cancer who were receiving no further treatment for pancreatic cancer other than best supportive care were included in this trial .
METHODS	They were stratified by prognosis and randomly allocated either to a group that received mistletoe treatment or to one that did not .
METHODS	Mistletoe extract was given in escalating doses by subcutaneous injection three times a week .
METHODS	The planned interim evaluation of data from 220 patients indicated that mistletoe treatment was associated with longer overall survival , and the trial was terminated prematurely .
METHODS	After termination of the study , the results with respect to quality of life ( assessed with the QLO-C30 scales of the European Organisation for Research and Treatment of Cancer ) and trends in body weight were evaluated .
RESULTS	Data on quality of life and body weight were obtained from 96 patients treated with mistletoe and 72 control patients .
RESULTS	Those treated with mistletoe did better on all 6 functional scales and on 7 of 9 symptom scales , including pain ( 95 % confidence interval [ CI ] -29 to -17 ) , fatigue ( 95 % CI -36.1 to -25.0 ) , appetite loss ( 95 % CI -51 to -36.7 ) , and insomnia ( 95 % CI -45.8 to -28.6 ) .
RESULTS	This is reflected by the trend in body weight during the trial .
CONCLUSIONS	In patients with locally advanced or metastatic pancreatic carcinoma , mistletoe treatment significantly improves the quality of life in comparison to best supportive care alone .
CONCLUSIONS	Mistletoe is an effective second-line treatment for this disease .

###24308704
OBJECTIVE	Immunohistochemical assessment of liver tissue in chronic delta hepatitis ( CDH ) is underinvestigated .
OBJECTIVE	Aim of the study was ( i ) to assess variables associated with hepatitis D antigen ( HDAg ) , hepatitis B surface antigen ( HBsAg ) and hepatitis B core antigen ( HBcAg ) staining in the liver .
METHODS	Demographic , biochemical and virologic data collected from the HIDIT 1 study were used .
METHODS	HBsAg , HBcAg and HDAg immunohistochemical ( IHC ) staining was semiquantitatively assessed .
RESULTS	Hepatitis D antigen immunohistochemical staining displayed positive correlations with age and alanine aminotransferase ( ALT ) and negative correlations with serum HBsAg ( P = 0.01 for all ) .
RESULTS	HBsAg IHC displayed a negative correlation with gamma glutamyl transferase and positive correlations with serum HBV DNA , serum HBsAg levels and HBeAg serology ( P < 0.001 , P = 0.02 and P = 0.007 respectively ) .
RESULTS	HBcAg staining was mainly nuclear and displayed negative correlations with serum HBsAg and histologic activity ( P = 0.002 and P = 0.02 respectively ) .
RESULTS	Pegylated IFN based treatment led to a decline of all IHC markers , however , these markers had no impact on treatment outcome .
CONCLUSIONS	These data suggest an association of liver injury with HDAg expression in CDH whereas the negative correlation between HBcAg expression and liver injury and the overall nuclear localization of HBcAg suggest that HBcAg does not contribute to liver injury in CDH .
CONCLUSIONS	HDV cases with high level of HBV replication , high serum HBsAg levels , HBeAg positivity , that are probably in the earlier stages of disease ( low gamma-glutamyl transferase ) , had a more intense HBsAg staining profile .
CONCLUSIONS	Overall , the data enforce the importance of HDAg and HBsAg in different phases of CDH infection .

###24385033
BACKGROUND	The traditional treatment for primary anterior shoulder dislocations has been immobilization in a sling with the arm in a position of adduction and internal rotation .
BACKGROUND	However , recent basic science and clinical data have suggested recurrent instability may be reduced with immobilization in external rotation after primary shoulder dislocation .
OBJECTIVE	We performed a randomized controlled trial to compare the ( 1 ) frequency of recurrent instability and ( 2 ) disease-specific quality-of-life scores after treatment of first-time shoulder dislocation using either immobilization in external rotation or immobilization in internal rotation in a group of young patients .
METHODS	Sixty patients younger than 35 years of age with primary , traumatic , anterior shoulder dislocations were randomized ( concealed , computer-generated ) to immobilization with either an internal rotation sling ( n = 29 ) or an external rotation brace ( n = 31 ) at a mean of 4 days after closed reduction ( range , 1-7 days ) .
METHODS	Patients with large bony lesions or polytrauma were excluded .
METHODS	The two groups were similar at baseline .
METHODS	Both groups were immobilized for 4 weeks with identical therapy protocols thereafter .
METHODS	Blinded assessments were completed by independent observers for a minimum of 12 months ( mean , 25 months ; range , 12-43 months ) .
METHODS	Recurrent instability was defined as a second documented anterior dislocation or multiple episodes of shoulder subluxation severe enough for the patient to request surgical stabilization .
METHODS	Validated disease-specific quality-of-life data ( Western Ontario Shoulder Instability index [ WOSI ] , American Shoulder and Elbow Surgeons evaluation [ ASES ] ) were also collected .
METHODS	Ten patients ( 17 % , five from each group ) were lost to followup .
METHODS	Reported compliance with immobilization in both groups was excellent ( 80 % ) .
RESULTS	With the numbers available , there was no difference in the rate of recurrent instability between groups : 10 of 27 patients ( 37 % ) with the external rotation brace versus 10 of 25 patients ( 40 % ) with the sling redislocated or developed symptomatic recurrent instability ( p = 0.41 ) .
RESULTS	WOSI scores were not different between groups ( p = 0.74 ) and , although the difference in ASES scores approached statistical significance ( p = 0.05 ) , the magnitude of this difference was small and of uncertain clinical importance .
CONCLUSIONS	Despite previous published findings , our results show immobilization in external rotation did not confer a significant benefit versus sling immobilization in the prevention of recurrent instability after primary anterior shoulder dislocation .
CONCLUSIONS	Further studies with larger numbers may elucidate whether functional outcomes , compliance , or comfort with immobilization can be improved with this device .
METHODS	Level I , therapeutic study .
METHODS	See Instructions for Authors for a complete description of levels of evidence .

###25515570
OBJECTIVE	We studied the correlation between outer nuclear layer ( ONL ) thickness and cone density in normal eyes and eyes with retinitis pigmentosa ( RP ) .
METHODS	Spectral-domain optical coherence tomography ( SD-OCT ) scans were acquired using a displaced pupil entry position of the scanning beam to distinguish Henle 's fiber layer from the ONL in 20 normal eyes ( 10 subjects ) and 12 eyes with RP ( 7 patients ) .
METHODS	Cone photoreceptors were imaged using adaptive optics scanning laser ophthalmoscopy .
METHODS	The ONL thickness and cone density were measured at 0.5 intervals along the horizontal meridian through the fovea nasally and temporally .
METHODS	The ONL thickness and cone density were correlated using Spearman 's rank correlation coefficient r.
RESULTS	Cone densities averaged over the central 6 were lower in eyes with RP than normal , but showed high variability in both groups .
RESULTS	The ONL thickness and cone density were significantly correlated when all retinal eccentricities were combined ( r = 0.74 ) ; the correlation for regions within 0.5 to 1.5 eccentricity was stronger ( r = 0.67 ) than between 1.5 and 3.0 eccentricity ( r = 0.23 ) .
RESULTS	Although cone densities were lower between 0.5 and 1.5 in eyes with RP , ONL thickness measures at identical retinal locations were similar in the two groups ( P = 0.31 ) , and interindividual variation was high for ONL and cone density measures .
RESULTS	Although ONL thickness and retinal eccentricity were important predictors of cone density , eccentricity was over 3 times more important .
CONCLUSIONS	The ONL thickness and cone density were correlated in normal eyes and eyes with RP , but both were strongly correlated with retinal eccentricity , precluding estimation of cone density from ONL thickness .
CONCLUSIONS	( ClinicalTrials.gov number , NCT00254605 . )

###25295709
BACKGROUND	The role of procalcitonin ( PCT ) , a widely used sepsis biomarker , in critically ill patients with sepsis is undetermined .
OBJECTIVE	To investigate the effect of a low PCT cut-off on antibiotic prescription and to describe the relationships between PCT plasma concentration and sepsis severity and mortality .
METHODS	This was a multicenter ( 11 Australian intensive care units [ ICUs ] ) , prospective , single-blind , randomized controlled trial involving 400 patients with suspected bacterial infection/sepsis and expected to receive antibiotics and stay in ICU longer than 24 hours .
METHODS	The primary outcome was the cumulative number of antibiotics treatment days at Day 28 .
RESULTS	PCT was measured daily while in the ICU .
RESULTS	A PCT algorithm , including 0.1 ng/ml cut-off , determined antibiotic cessation .
RESULTS	Published guidelines and antimicrobial stewardship were used in all patients .
RESULTS	Primary analysis included 196 ( PCT ) versus 198 standard care patients .
RESULTS	Ninety-three patients in each group had septic shock .
RESULTS	The overall median ( interquartile range ) number of antibiotic treatment days were 9 ( 6-21 ) versus 11 ( 6-22 ) , P = 0.58 ; in patients with positive pulmonary culture , 11 ( 7-27 ) versus 15 ( 8-27 ) , P = 0.33 ; and in patients with septic shock , 9 ( 6-22 ) versus 11 ( 6-24 ) , P = 0.64 ; with an overall 90-day all-cause mortality of 35 ( 18 % ) versus 31 ( 16 % ) , P = 0.54 in the PCT versus standard care , respectively .
RESULTS	Using logistic regression , adjusted for age , ventilation status , and positive culture , the decline rate in log ( PCT ) over the first 72 hours independently predicted hospital and 90-day mortality ( odds ratio [ 95 % confidence interval ] , 2.76 [ 1.10-6 .96 ] , P = 0.03 ; 3.20 [ 1.30-7 .89 ] , P = 0.01 , respectively ) .
CONCLUSIONS	In critically ill adults with undifferentiated infections , a PCT algorithm including 0.1 ng/ml cut-off did not achieve 25 % reduction in duration of antibiotic treatment .
CONCLUSIONS	Clinical trial registered with http://www.anzctr.org.au ( ACTRN12610000809033 ) .

###25199531
BACKGROUND	In contrast to drug-sensitive tuberculosis , the guidelines for the treatment of multi-drug-resistant tuberculosis ( MDR-TB ) have a very poor evidence base ; current recommendations , based on expert opinion , are that patients should be treated for a minimum of 20 months .
BACKGROUND	A series of cohort studies conducted in Bangladesh identified a nine-month regimen with very promising results .
BACKGROUND	There is a need to evaluate this regimen in comparison with the currently recommended regimen in a randomized controlled trial in a variety of settings , including patients with HIV-coinfection .
METHODS	STREAM is a multi-centre randomized trial of non-inferiority design comparing a nine-month regimen to the treatment currently recommended by the World Health Organization in patients with MDR pulmonary TB with no evidence on line probe assay of fluoroquinolone or kanamycin resistance .
METHODS	The nine-month regimen includes clofazimine and high-dose moxifloxacin and can be extended to 11 months in the event of delay in smear conversion .
METHODS	The primary outcome is based on the bacteriological status of the patients at 27 months post-randomization .
METHODS	Based on the assumption that the nine-month regimen will be slightly more effective than the control regimen and , given a 10 % margin of non-inferiority , a total of 400 patients are required to be enrolled .
METHODS	Health economics data are being collected on all patients in selected sites .
CONCLUSIONS	The results from the study in Bangladesh and cohorts in progress elsewhere are encouraging , but for this regimen to be recommended more widely than in a research setting , robust evidence is needed from a randomized clinical trial .
CONCLUSIONS	Results from the STREAM trial together with data from ongoing cohorts should provide the evidence necessary to revise current recommendations for the treatment for MDR-TB .
BACKGROUND	This trial was registered with clincaltrials.gov ( registration number : ISRCTN78372190 ) on 14 October 2010 .

###26072346
OBJECTIVE	To determine the effectiveness of part-time patching for treating intermittent exotropia ( IXT ) in young children .
METHODS	Multicenter , randomized clinical trial .
METHODS	Two hundred one children 12 to 35 months of age with untreated IXT meeting the following criteria : ( 1 ) IXT at distance OR constant exotropia at distance and either IXT or exophoria at near , and ( 2 ) 15-prism diopter ( ) or more exodeviation at distance or near by prism and alternate cover test ( PACT ) but at least 10 exodeviation at distance by PACT .
METHODS	Participants were assigned randomly to either observation ( no treatment for 6 months ) or patching prescribed for 3 hours daily for 5 months , followed by 1 month of no patching .
METHODS	The primary outcome was deterioration , defined as constant exotropia measuring at least 10 at distance and near or receipt of nonprotocol treatment for IXT .
RESULTS	Of the 177 participants ( 88 % ) completing the 6-month primary outcome examination , deterioration occurred in 4.6 % ( 4 of 87 ) of the participants in the observation group and in 2.2 % ( 2 of 90 ) of the participants in the patching group ( difference , 2.4 % ; P = 0.27 ; 95 % confidence interval , -3.8 % to +9.4 % ) .
RESULTS	Motor deterioration occurred in 2.3 % ( 2 of 87 ) of the observation group and in 2.2 % ( 2 of 90 ) of the patching group ( difference , 0.08 % ; P = 0.55 ; 95 % confidence interval , -5.8 % to +6.1 % ) .
RESULTS	For the observation and patching groups , respectively , 6-month mean PACT measurements were 27.9 versus 24.9 at distance ( P = 0.02 ) and 19.3 versus 17.0 at near ( P = 0.10 ) ; 6-month mean exotropia control scores were 2.8 versus 2.3 points at distance ( P = 0.02 ) and 1.4 versus 1.1 points at near ( P = 0.26 ) .
CONCLUSIONS	Among children 12 to 35 months of age with previously untreated IXT , deterioration over 6 months was uncommon , with or without patching treatment .
CONCLUSIONS	There was insufficient evidence to recommend part-time patching for the treatment of IXT in children in this age group .

###26154184
BACKGROUND	Despite ultrasound guidance for central line placement , complications persist , as exact needle location is often difficult to confirm with standard two-dimension ultrasound .
BACKGROUND	A novel real-time needle guidance technology has recently become available ( eZono , Germany ) that tracks the needle during insertion .
BACKGROUND	This randomized , blinded , crossover study examined whether this needle guidance technology improved cannulation of a simulated internal jugular ( IJ ) vein in an ultrasound phantom .
METHODS	One hundred physicians were randomized to place a standard needle in an ultrasound neck phantom with or without the needle guidance system .
METHODS	Video cameras were placed externally and within the lumens of the vessels to record needle location in real time .
METHODS	The primary outcome measured was the rate of posterior wall puncture .
METHODS	Secondary outcomes included number of carotid artery punctures , number of needle passes , final needle position , time to cannulation , and comfort level with this new technology .
RESULTS	The incidence of posterior vessel wall puncture without and with needle guidance was 49 and 13 % , respectively ( P < 0.001 , odds ratio [ OR ] = 7.33 [ 3.44 to 15.61 ] ) .
RESULTS	The rate of carotid artery puncture was higher without needle navigation technology than with needle navigation 21 versus 2 % , respectively ( P = 0.001 , OR = 12.97 [ 2.89 to 58.18 ] ) .
RESULTS	Final needle tip position being located within the lumen of the IJ was 97 % accurate with the navigation technology and 76 % accurate with standard ultrasound ( P < 0.001 , OR = 10.42 [ 2.76 to 40.0 ] ) .
RESULTS	Average time for successful vessel cannulation was 1.37 times longer without guidance technology .
CONCLUSIONS	This real-time needle guidance technology ( eZono ) shows significant improvement in needle accuracy and cannulation time during simulated IJ vein puncture .

###24861192
OBJECTIVE	To compare the hemodynamics after combined spinal-epidural anesthesia ( CSEA ) between decubitus and sitting positions in aged patients undergoing total hip replacement .
METHODS	A total of 80 aged patients who underwent CSEA for elective total hip replacement were randomly divided into a decubitus position group ( group D ) and a sitting position group ( group S ; each group with 40 patients ) .
METHODS	In group D , 10 mg of 0.5 % bupivacaine were given into the subarachnoid space in decubitus position .
METHODS	In group S , 10 mg of 0.5 % bupivacaine were given into the subarachnoid space in the sitting position , which was maintained for 1 min , after which the patients were in decubitus position .
METHODS	In both groups , the sensory block levels and changes in hemodynamics were assessed .
RESULTS	The mean arterial blood pressure was significantly higher in group S than in group D at each time point within 30 min after anesthesia .
RESULTS	There were no significant differences in heart rate between the two groups at each time point .
RESULTS	There was also no significant difference in the level of sensory block between the two groups 20 min after the administration of CSEA .
CONCLUSIONS	For aged patients undergoing total hip replacement , CSEA is safer and more effective in the sitting position than in decubitus position .

###24345329
OBJECTIVE	Pathological gambling is associated with elevated proportions of nicotine dependence , and tobacco smoking in pathological gamblers has been associated with increased problem-gambling severity .
OBJECTIVE	This study examined the addition of N-acetylcysteine to imaginal desensitization in adults with co-occurring nicotine dependence and pathological gambling .
METHODS	Twenty-eight individuals with co-occurring DSM-IV nicotine dependence and pathological gambling who were receiving behavioral therapy were recruited from December 2009 to February 2012 and randomized to augmentation with N-acetylcysteine or placebo in an 12-week , double-blind trial .
METHODS	Subjects were assessed with measures of nicotine and gambling severity and followed for 3 months after treatment .
METHODS	The primary outcomes were the Fagerstrm Test for Nicotine Dependence and the pathological gambling adaptation of the Yale-Brown Obsessive-Compulsive Scale .
RESULTS	During the first 6 weeks , there was a significant benefit of N-acetylcysteine treatment versus placebo on Fagerstrm Test for Nicotine Dependence total scores ( t = -2.224 ; P = .031 ) .
RESULTS	After the initial 6 weeks , all subjects significantly ( P < .001 ) benefited from imaginal desensitization .
RESULTS	During the 3-month follow-up , there was a significant additional benefit for N-acetylcysteine versus placebo on measures of problem-gambling severity ( t = 2.069 ; P = .043 ) .
CONCLUSIONS	N-acetylcysteine treatment during therapy facilitates long-term application of behavioral therapy techniques once patients are in the community after therapy has been completed .
BACKGROUND	ClinicalTrials.gov identifier : NCT00967005 .

###24515510
OBJECTIVE	To compare the effect of 800 vs 400 IU of daily oral vitamin D3 on the prevalence of vitamin D deficiency ( VDD ) at 40 weeks ' postmenstrual age ( PMA ) in preterm infants of 28 to 34 weeks ' gestation .
METHODS	In this randomized double-blind trial , we allocated eligible infants to receive either 800 or 400 IU of vitamin D3 per day ( n = 48 in both groups ) .
METHODS	Primary outcome was VDD ( serum 25-hydroxyvitamin D levels < 20 ng/mL ) at 40 weeks ' PMA .
METHODS	Secondary outcomes were VDD , bone mineral content , and bone mineral density at 3 months ' corrected age ( CA ) .
RESULTS	Prevalence of VDD in the 800-IU group was significantly lower than in the 400-IU group at 40 weeks ( 38.1 % vs. 66.7 % ; relative risk : 0.57 ; 95 % confidence interval : 0.37-0 .88 ) and at 3 months ' CA ( 12.5 % vs. 35 % ; relative risk : 0.36 ; 95 % confidence interval : 0.14-0 .90 ) .
RESULTS	One infant ( 2.4 % ) in the 800-IU group had vitamin D excess ( 100-150 ng/mL ) .
RESULTS	Bone mineral content ( mean SD : 79.6 16.8 vs. 84.7 20.7 g ; P = .27 ) and bone mineral density ( 0.152 0.019 vs. 0.158 0.021 g/cm2 ; P = .26 ) were not different between the 2 groups .
CONCLUSIONS	Daily supplementation with 800 IU of vitamin D reduces the prevalence of VDD at 40 weeks ' PMA and at 3 months ' CA in preterm infants without showing any improvement in bone mineralization .
CONCLUSIONS	However , there is a possibility that this dose may occasionally result in vitamin D excess .

###24506852
OBJECTIVE	To explore the effect of early goal-directed therapy ( EGDT ) according to pulse indicated continuous cardiac output ( PiCCO ) on septic shock patients .
METHODS	Eighty-two septic shock patients in Subei People 's Hospital of Jiangsu Province from January 2009 to December 2012 were enrolled and randomly divided into two groups using a random number table , standard surviving sepsis bundle group ( n = 40 ) and modified surviving sepsis bundles group ( n = 42 ) .
METHODS	The patients received the standard EGDT bundles in standard surviving sepsis bundle group .
METHODS	PiCCO catheter was placed in modified surviving sepsis bundles group .
METHODS	Fluid resuscitation was guided by intrathoracic blood volume index ( ITBVI ) with the aim of 850-1 000 mL/m ( 2 ) .
METHODS	Dobutamine was used to improve the heart function according to left ventricular contractile index ( dPmax ) and stroke volume index ( SVI ) .
METHODS	The mean arterial blood pressure ( MAP ) was maintained 65 mmHg ( 1 mmHg = 0.133 kPa ) or above with norepinephrine .
METHODS	Extra-vascular lung water was monitored for the titration of liquid and diuretics .
METHODS	The acute physiology and chronic health evaluation II ( APACHEII ) score , sequential organ failure assessment ( SOFA ) score , the number of patients needed vasopressor , serum procalcitonin ( PCT ) , lactic acid and lactate extraction ratio , the amount of fluid resuscitation , duration of mechanical ventilation , duration of intensive care unit ( ICU ) stay , hospital mortality were recorded in both groups .
RESULTS	After treatment , the APACHEII score , SOFA score and the number of patients needed vasopressor were gradually reduced in both groups , and those in modified surviving sepsis bundle group were significantly lower than those of standard sepsis bundle group at 72 hours ( APACHEII score : 13.16.5 vs. 20.97.5 , SOFA score : 8.84.3 vs. 14.64.9 , the number of patients needed vasopressor : 8 vs. 17 , all P < 0.05 ) .
RESULTS	Arterial blood lactate clearance rate was gradually increased after treatment in both groups .
RESULTS	Lactate clearance rate in modified surviving sepsis bundle group was significantly higher than that of standard surviving sepsis bundle group [ 6 hours : ( 18.28.3 ) % vs. ( 10.87.5 ) % , t = -6.036 , P = 0.001 ; 12 hours : ( 22.67.3 ) % vs. ( 12.48.1 ) % , t = -4.536 , P = 0.001 ; 24 hours : ( 27.85.6 ) % vs. ( 16.49.5 ) % , t = -5.882 , P = 0.000 ] .
RESULTS	The amount of fluid resuscitation within 6 hours in modified surviving sepsis bundle group increased significantly compared with standard surviving sepsis bundle group ( 3 608715 mL vs. 2 809795 mL , t = -3.865 , P = 0.033 ) .
RESULTS	The amount of fluid resuscitation within 24 , 48 and 72 hours in modified surviving sepsis bundle group was significantly less than that of standard modified surviving sepsis bundle group with the nadir at 72 hours ( 918351 mL vs. 1 805420 mL , t = 5.907 , P = 0.037 ) .
RESULTS	Duration of mechanical ventilation ( 98.420.3 hours vs. 143.329.6 hours , t = 9.766 , P = 0.001 ) and ICU stay ( 7.13.1 days vs. 9.52.5 days , t = 2.993 , P = 0.004 ) were significantly reduced in modified surviving sepsis bundle group compared with standard surviving sepsis bundle group .
RESULTS	The hospital mortality in modified surviving sepsis bundle group was slightly lower than that in standard surviving sepsis bundle group [ 16.7 % ( 7/42 ) vs. 17.5 % ( 7/40 ) , ( 2 ) = 0.010 , P = 0.920 ] .
CONCLUSIONS	Modified surviving sepsis bundle treatment according PiCCO can reduce the severity of disease in patients with septic shock , can make more accurately guide fluid resuscitation , and can reduce lung water and duration of mechanical ventilation and ICU stay .
CONCLUSIONS	It has great clinical significance .

###25502137
OBJECTIVE	Identifying the modality and fidelity of simulation that offers the greatest benefit to the learner is critical to Advanced Cardiac Life Support ( ACLS ) training .
OBJECTIVE	Our hypothesis is that participants who receive ACLS training on high-fidelity mannequins will perform better than those trained on low-fidelity mannequins .
METHODS	The study was performed in the context of an ACLS Initial Provider course for new postgraduate year 1 residents and involved 3 training arms : ( 1 ) low-fidelity , ( 2 ) mid-fidelity , and ( 3 ) high-fidelity .
METHODS	Educational outcomes were evaluated by written scores , student evaluations of the course , and expert rater reviews of megacode performance .
RESULTS	A convenience sample of 54 subjects was randomized to 1 of the 3 training arms .
RESULTS	All 3 groups significantly improved based on written posttest scores ( P < 0.0001 ) ; however , pretest to posttest improvement among the 3 training arms was not significantly different : low-fidelity = 42.3 ( 95 % CI , 35.7-48 .9 ) ; mid-fidelity = 41.3 ( 95 % CI , 34.7-47 .9 ) ; high-fidelity = 40.8 ( 95 % CI , 34.3-47 .5 ; P = 0.95 ) .
RESULTS	All participants felt the simulator environment was realistic regardless of level of fidelity .
RESULTS	Participants in the high-fidelity group were less likely to feel comfortable in the simulator environment ( P = 0.0045 ) .
RESULTS	Clinical performance as assessed by expert raters ' megacode scores was better for high-fidelity ( 66.3 ) than mid-fidelity ( 60.1 ) ( P = 0.04 ) .
CONCLUSIONS	Overall , there was no difference among the 3 groups in test scores or perceived instructor or course quality ; however , subjects trained on high-fidelity mannequins performed better than those trained on mid-fidelity with respect to megacode performance .

###24756514
OBJECTIVE	Acetazolamide is commonly used to treat idiopathic intracranial hypertension ( IIH ) , but there is insufficient information to establish an evidence base for its use .
OBJECTIVE	To determine whether acetazolamide is beneficial in improving vision when added to a low-sodium weight reduction diet in patients with IIH and mild visual loss .
METHODS	Multicenter , randomized , double-masked , placebo-controlled study of acetazolamide in 165 participants with IIH and mild visual loss who received a low-sodium weight-reduction diet .
METHODS	Participants were enrolled at 38 academic and private practice sites in North America from March 2010 to November 2012 and followed up for 6 months ( last visit in June 2013 ) .
METHODS	All participants met the modified Dandy criteria for IIH and had a perimetric mean deviation ( PMD ) between -2 dB and -7 dB .
METHODS	The mean age was 29 years and all but 4 participants were women .
METHODS	Low-sodium weight-reduction diet plus the maximally tolerated dosage of acetazolamide ( up to 4 g/d ) or matching placebo for 6 months .
METHODS	The planned primary outcome variable was the change in PMD from baseline to month 6 in the most affected eye , as measured by Humphrey Field Analyzer .
METHODS	Perimetric mean deviation is a measure of global visual field loss ( mean deviation from age-corrected normal values ) , with a range of 2 to -32 dB ; larger negative values indicate greater vision loss .
METHODS	Secondary outcome variables included changes in papilledema grade , quality of life ( Visual Function Questionnaire 25 [ VFQ-25 ] and 36-Item Short Form Health Survey ) , headache disability , and weight at month 6 .
RESULTS	The mean improvement in PMD was greater with acetazolamide ( 1.43 dB , from -3.53 dB at baseline to -2.10 dB at month 6 ; n = 86 ) than with placebo ( 0.71 dB , from -3.53 dB to -2.82 dB ; n = 79 ) ; the difference was 0.71 dB ( 95 % CI , 0 to 1.43 dB ; P = .050 ) .
RESULTS	Mean improvements in papilledema grade ( acetazolamide : -1.31 , from 2.76 to 1.45 ; placebo : -0.61 , from 2.76 to 2.15 ; treatment effect , -0.70 ; 95 % CI , -0.99 to -0.41 ; P < .001 ) and vision-related quality of life as measured by the National Eye Institute VFQ-25 ( acetazolamide : 8.33 , from 82.97 to 91.30 ; placebo : 1.98 , from 82.97 to 84.95 ; treatment effect , 6.35 ; 95 % CI , 2.22 to 10.47 ; P = .003 ) and its 10-item neuro-ophthalmic supplement ( acetazolamide : 9.82 , from 75.45 to 85.27 ; placebo : 1.59 , from 75.45 to 77.04 ; treatment effect , 8.23 ; 95 % CI , 3.89 to 12.56 ; P < .001 ) were also observed with acetazolamide .
RESULTS	Participants assigned to acetazolamide also experienced a reduction in weight ( acetazolamide : -7.50 kg , from 107.72 kg to 100.22 kg ; placebo : -3.45 kg , from 107.72 kg to 104.27 kg ; treatment effect , -4.05 kg , 95 % CI , -6.27 to -1.83 kg ; P < .001 ) .
CONCLUSIONS	In patients with IIH and mild visual loss , the use of acetazolamide with a low-sodium weight-reduction diet compared with diet alone resulted in modest improvement in visual field function .
CONCLUSIONS	The clinical importance of this improvement remains to be determined .
BACKGROUND	clinicaltrials.gov Identifier : NCT01003639 .

###24506666
BACKGROUND	A gel containing diclofenac and hyaluronic acid ( DHA ) and photodynamic therapy with methyl aminolaevulinate ( MAL-PDT ) are widely used treatments for actinic keratoses ( AKs ) .
OBJECTIVE	The aim of this single-centre , open-label , prospective , nonsponsored , randomized controlled clinical trial was to compare the treatment results and cost-effectiveness of MAL-PDT and DHA .
METHODS	Patients with multiple AKs of the face and scalp were randomized to receive MAL-PDT or DHA .
METHODS	After 90days , the overall complete remission ( CR ) rate of patients and the CR rate of lesions according to thickness score were assessed , and patients and an investigator scored the cosmetic outcome .
METHODS	In addition , patients scored their overall satisfaction with the treatment .
METHODS	Patients with CR of all lesions were followed up for 12months .
RESULTS	Two hundred patients with a total of 1674 AKs were enrolled .
RESULTS	The lesion CR rates at 3months were 859 % with MAL-PDT and 518 % with DHA ( P < 00001 ) .
RESULTS	AKs of all thicknesses were significantly more responsive to MAL-PDT .
RESULTS	The patient CR rates at 3months were 68 % with MAL-PDT and 27 % with DHA .
RESULTS	At the 12-month examination , the number of patients with CR reduced to 37 with MAL-PDT and seven with DHA .
RESULTS	Rating of cosmetic outcome was very good or excellent in the vast majority of patients with both treatments .
RESULTS	The analysis of cost-effectiveness showed that the costs per patient with CR at 3months and at 12months are 5667 and 10262 , respectively , with MAL-PDT and 5952 and 22956 , respectively , with DHA .
CONCLUSIONS	Efficacy , cosmetic outcome and patients ' overall satisfaction with MAL-PDT are superior in comparison with DHA .
CONCLUSIONS	MAL-PDT is more expensive but it is more cost-effective .

###25214161
BACKGROUND	Iron deficiency anaemia ( IDA ) is a common nutritional problem .
OBJECTIVE	To determine the effect of nutritional education and supplemental iron administration on the prevalence of IDA in Arab infants .
METHODS	Three hundred and ten infants were randomized alternately into two groups .
METHODS	Mothers ( n = 143 ) in the control group received standard information on prevention of IDA and mothers in the intervention group ( n = 144 ) received extensive information on the importance of an iron-rich diet .
METHODS	Data was scored regarding diet contents .
METHODS	Mothers in the intervention group were encouraged to give their children an iron polymaltose complex ( IPC ) preparation starting from age 4 months to 1 year .
METHODS	Compliance of receiving the medication was evaluated .
METHODS	The groups were compared for outcome by chi-square test .
METHODS	Main outcome measures were haemoglobin ( Hb ) , mean corpuscular volume ( MCV ) , and serum ferritin levels .
RESULTS	Anaemia ( Hb < 11 g/dL ) was recorded in 28 % and 34 % of the intervention and control groups , respectively ( p = NS ) .
RESULTS	There was no effect of infant or parental background factors on rate of anaemia .
RESULTS	Frequency of anaemia was lower in infants who received 6 months of iron medication according to mothers ' reports , and in infants breastfed for 6 months ( p = 0.002 ) .
CONCLUSIONS	Questions were raised regarding the strategies of preventing IDA in infancy .

###24819707
BACKGROUND	Few studies have measured the ability of interventions to affect declining - cell function in screen-detected type 2 diabetes .
BACKGROUND	The Early Diabetes Intervention Programme ( ClinicalTrials.gov NCT01470937 ) was a randomized study based on the hypothesis that improving postprandial glucose excursions with acarbose would slow the progression of fasting hyperglycaemia in screen-detected type 2 diabetes .
BACKGROUND	In the Early Diabetes Intervention Programme , the effect of acarbose plus lifestyle advice on progression of fasting hyperglycaemia over a 5-year period was not greater than that of placebo .
BACKGROUND	However , there was an early glucose-lowering effect of the trial .
BACKGROUND	The objective of the current secondary analysis was to describe - cell function changes in response to glucose lowering .
METHODS	Participants were overweight adult subjects with screen-detected type 2 diabetes .
METHODS	- cell function was measured using hyperglycaemic clamps and oral glucose tolerance testing .
METHODS	The primary outcome was the change in - cell function from baseline to year 1 , the time point where the maximal glucose-lowering effect was seen .
RESULTS	At baseline , participants exhibited markedly impaired first-phase insulin response .
RESULTS	Despite significant reductions in weight , fasting plasma glucose ( PG ) and 2-h PG , there was no clinically significant improvement in the first-phase insulin response .
RESULTS	Late-phase insulin responses declined despite beneficial glycaemic effects of interventions .
CONCLUSIONS	Insulin secretion is already severely impaired in early , screen-detected type 2 diabetes .
CONCLUSIONS	Effective glucose-lowering intervention with acarbose was not sufficient to improve insulin secretion or halt the decline of - cell function .

###24962744
OBJECTIVE	Uncomplicated acute type B aortic dissection ( AD ) treated conservatively has a 10 % 30-day mortality and up to 25 % need intervention within 4 years .
OBJECTIVE	In complicated AD , stent grafts have been encouraging .
OBJECTIVE	The aim of the present prospective randomised trial was to compare best medical treatment ( BMT ) with BMT and Gore TAG stent graft in patients with uncomplicated AD .
OBJECTIVE	The primary endpoint was a combination of incomplete/no false lumen thrombosis , aortic dilatation , or aortic rupture at 1 year .
METHODS	The AD history had to be less than 14 days , and exclusion criteria were rupture , impending rupture , malperfusion .
METHODS	Of the 61 patients randomised , 80 % were DeBakey type IIIB .
RESULTS	Thirty-one patients were randomised to the BMT group and 30 to the BMT+TAG group .
RESULTS	Mean age was 63 years for both groups .
RESULTS	The left subclavian artery was completely covered in 47 % and in part in 17 % of the cases .
RESULTS	During the first 30 days , no deaths occurred in either group , but there were three crossovers from the BMT to the BMT+TAG group , all due to progression of disease within 1 week .
RESULTS	There were two withdrawals from the BMT+TAG group .
RESULTS	At the 1-year follow up there had been another two failures in the BMT group : one malperfusion and one aneurysm formation ( p = .056 for all ) .
RESULTS	One death occurred in the BMT+TAG group .
RESULTS	For the overall endpoint BMT+TAG was significantly different from BMT only ( p < .001 ) .
RESULTS	Incomplete false lumen thrombosis , was found in 13 ( 43 % ) of the TAG+BMT group and 30 ( 97 % ) of the BMT group ( p < .001 ) .
RESULTS	The false lumen reduced in size in the BMT+TAG group ( p < .001 ) whereas in the BMT group it increased .
RESULTS	The true lumen increased in the BMT+TAG ( p < .001 ) whereas in the BMT group it remained unchanged .
RESULTS	The overall transverse diameter was the same at the beginning and after 1 year in the BMT group ( 42.1 mm ) , but in the BMT+TAG it decreased ( 38.8 mm ; p = .062 ) .
CONCLUSIONS	Uncomplicated AD can be safely treated with the Gore TAG device .
CONCLUSIONS	Remodelling with thrombosis of the false lumen and reduction of its diameter is induced by the stent graft , but long term results are needed .

###25441237
BACKGROUND	Despite the established benefits of exercise for adults with arthritis , participation is low .
BACKGROUND	Safe , evidence-based , self-directed programs , which have the potential for high reach at a low cost , are needed .
OBJECTIVE	To test a 12-week , self-directed , multicomponent exercise program for adults with arthritis .
METHODS	Randomized controlled trial .
METHODS	Data were collected from 2010 to 2012 .
METHODS	Data were analyzed in 2013 and 2014 .
METHODS	Adults with arthritis ( N = 401 , aged 56.3 [ 10.7 ] years , 85.8 % women , 63.8 % white , 35.2 % African American , BMI of 33.0 [ 8.2 ] ) completed measures at a university research center and participated in a self-directed exercise intervention ( First Step to Active Health ( ) ) or nutrition control program ( Steps to Healthy Eating ) .
METHODS	Intervention participants received a self-directed multicomponent exercise program and returned self-monitoring logs for 12 weeks .
METHODS	Self-reported physical activity , functional performance measures , and disease-specific outcomes ( arthritis symptoms and self-efficacy ) assessed at baseline , 12 weeks , and 9 months .
RESULTS	Participants in the exercise condition showed greater increases in physical activity than those in the nutrition control group ( p = 0.01 ) .
RESULTS	Significant improvements , irrespective of condition , were seen in lower body strength , functional exercise capacity , lower body flexibility , pain , fatigue , stiffness , and arthritis management self-efficacy ( p values < 0.0001 ) .
RESULTS	More adverse events occurred in the exercise than nutrition control condition , but only one was severe and most were expected with increased physical activity .
CONCLUSIONS	The exercise program improves physical activity , and both programs improve functional and psychosocial outcomes .
CONCLUSIONS	Potential reasons for improvements in the nutrition control condition are discussed .
CONCLUSIONS	These interventions have the potential for large-scale dissemination .
CONCLUSIONS	This study is registered at Clinicaltrials.gov NCT01172327 .

###24926950
BACKGROUND	We have recently demonstrated short-term ( 6-month ) efficacy and safety of leuprolide acetate 3-month depot 11.25 and 30 mg in children with central precocious puberty ( CPP ) .
OBJECTIVE	To assess long-term ( 36-month ) hypothalamic-pituitary-gonadal axis suppression and safety of leuprolide acetate 3-month depot 11.25 and 30 mg in children with CPP .
METHODS	Open-label , 36-month extension .
METHODS	Twenty pediatric endocrine centers .
METHODS	Seventy-two children ( mean age , 8.5 1.6 y ; 65 females ) with CPP completed and showed maintenance of LH suppression after a 6-month lead-in study .
METHODS	Leuprolide acetate depot ( 11.25 or 30 mg ) administered im every 3 months .
METHODS	Peak-stimulated LH , estradiol , T , growth rate , pubertal progression , and adverse events ( AEs ) .
RESULTS	Twenty-nine of 34 subjects in the 11.25-mg group and 36 of 38 subjects in the 30-mg group had LH values < 4 mIU/mL after day 1 at all time points .
RESULTS	All seven subjects who escaped LH suppression at any time still maintained sex steroid concentrations at prepubertal levels and showed no signs of pubertal progression .
RESULTS	AEs were comparable between groups , with injection site pain being the most common ( 26.4 % overall ) .
RESULTS	No AE led to discontinuation of study drug .
RESULTS	The safety profile over 36 months was comparable to that observed during the 6-month pivotal study .
CONCLUSIONS	The two doses of leuprolide acetate 3-month depot were associated with an acceptable safety profile and provided maintenance of LH suppression in the majority of children with CPP during the 36 months of the study or until readiness for puberty .

###25252192
BACKGROUND	Patients with renal insufficiency are hyporesponsive to vaccination , including to hepatitis B vaccines .
BACKGROUND	A manufacturing process modification for a hepatitis B vaccine ( mpHBV ) was studied in renal pre-dialysis and dialysis patients .
METHODS	This randomized , open-label , multicenter , estimation study enrolled previously unvaccinated , HBV-seronegative adult dialysis and pre-dialysis patients ( N = 276 , median age 72.0 years ) .
METHODS	At 0 , 1 , 6 , and 8 months , group 1 received a 1 mL intramuscular dose of mpHBV ( containing 40 g HBsAg ) as a single injection , while group 2 received a 1 mL intramuscular dose of a licensed hepatitis B vaccine as two injections ( each containing 20 g HBsAg ; 40 g HBsAg total ) .
METHODS	Serum antibody to HBsAg ( anti-HBs ) was measured predose 1 , and 1 month postdose 3 and 4 .
METHODS	Anti-HBs geometric mean concentration ( GMC ) and seroprotection rate ( SPR , % of subjects with anti-HBs titer 10 mIU/mL ) were estimated at months 7 and 9 .
RESULTS	For group 1 , month 7 SPR was 48.5 % ( 49/101 , 95 % CI : 38.4 % , 58.7 % ) ; with an additional dose , month 9 SPR increased to 66.7 % ( 66/99 , 95 % CI : 56.5 % , 75.8 % ) .
RESULTS	For group 2 , month 7 SPR was 57.7 % ( 64/111 , 95 % CI : 47.9 % , 67.0 % ) ; with an additional dose , month 9 SPR increased to 69.2 % ( 72/104 , 95 % CI : 59.4 % , 77.9 % ) .
RESULTS	group 1 GMCs at months 7 and 9 were 27.5 mIU/mL ( 95 % CI : 15.7 , 48.0 ) and 61.7 mIU/mL ( 95 % CI : 34.2 , 111.5 ) , respectively .
RESULTS	group 2 GMCs at months 7 and 9 were 48.7 mIU/mL ( 95 % CI : 28.7 , 82.7 ) and 115.8 mIU/mL ( 95 % CI : 65.2 , 205.5 ) , respectively .
RESULTS	There were 22 serious adverse events ; none were considered related to study vaccine .
CONCLUSIONS	Both formulations were immunogenic in this population but required more vaccinations to reach seroprotective levels than comparable regimens in healthy individuals , as expected .
CONCLUSIONS	The relatively reduced SPRs seen in this population support the need for routine screening and re-dosing in this population .

###24331343
BACKGROUND	Inflammation plays a key role in the development of benign prostatic hyperplasia .
BACKGROUND	Prostaglandin E2 ( PGE2 ) is an important inflammation factor found in enlarged prostatic tissue that can be the main cause of inflammatory pain .
BACKGROUND	The aim of this study was to investigate whether epidural anesthesia can block the negative effects of prostaglandin mediators during prostate surgery .
METHODS	The study included 60 patients who underwent open prostatectomy .
METHODS	All patients were randomly allocated to one of two study groups .
METHODS	The first group received general anesthesia and the second group a combination of general and epidural anesthesia .
METHODS	Main outcome measures were plasma concentration of PGE2 , adrenaline , noradrenaline , and dopamine , before induction of anesthesia and at the time of enucleation .
RESULTS	Preoperative serum concentrations of PGE2 were high in both groups .
RESULTS	During enucleation , serum concentrations of adrenaline , noradrenaline , and dopamine increased , followed by a rise of systolic and diastolic blood pressure in the group of patients that received only general anesthesia .
RESULTS	Serum concentration of PGE2 was at the same level as before induction of anesthesia in both groups .
CONCLUSIONS	Epidural anesthesia blocks transmission of painful stimulus through the spinal cord caused by prostaglandin release and prevents the rise of catecholamines and blood pressure .
CONCLUSIONS	Open prostatectomy can become a safer procedure performed under a combination of general and epidural anesthesia .
CONCLUSIONS	Negative intraoperative effects of inflammatory prostate mediators during other techniques for prostate surgery could also be blocked with epidural anesthesia .

###24472224
BACKGROUND	Population pharmacokinetics ( PK ) of azithromycin ( AZ ) and chloroquine ( CQ ) following administration of fixed-dose combination tablet formulations of AZ and CQ ( AZCQ ) was evaluated using data from two studies : 1 ) in children with symptomatic uncomplicated falciparum malaria in sub-Saharan Africa ; and 2 ) in healthy adults in the United States .
METHODS	Study 1 included paediatric subjects randomized to either AZCQ or artemether-lumefantrine treatment in Cohort 1 ( age 5-12years ) and Cohort 2 ( age 6-59months ) .
METHODS	Dosing of AZCQ was approximately 30mg/kg AZ and 10mg/kg CQ once daily for 3 days ( for 20kg weight : AZ/CQ 300/100mg per tablet ; 5 to < 20kg weight : AZ/CQ 150/50mg per tablet ) .
METHODS	Study 2 included adults randomized to receive either two AZCQ tablets ( AZ/CQ 250/155mg per tablet ) or individual commercial tablets of AZ 500mg and CQ 300mg .
METHODS	Serum AZ and plasma CQ concentrations from both studies were pooled .
METHODS	Population PK models were constructed using standard approaches to evaluate the concentration-time data for AZ and CQ and to identify any covariates predictive of PK behaviour .
RESULTS	A three-compartment PK model with linear clearance and absorption adequately described AZ data , while a two-compartment model with linear clearance and absorption and an absorption lag adequately described CQ data .
RESULTS	No overall bias or substantial model misspecification was evident using diagnostic plots and visual predictive checks .
RESULTS	Body weight as an allometric function was the only covariate in the final AZ and CQ PK models .
RESULTS	There were significantly lower AZ ( 0.488 vs 0.745 [ mgh/L ] / [ mg/kg ] , p < 0.00001 ) and CQ ( 0.836 vs 1.27 [ mgh/L ] / [ mg/kg ] , p < 0.00001 ) exposures ( AUCinf ) normalized by dose ( mg/kg ) in children compared with the adults .
CONCLUSIONS	The PK of AZ and CQ following administration of AZCQ was well described using a three - and two-compartment model , respectively .
CONCLUSIONS	AZ and CQ exhibited linear absorption and clearance ; the model for CQ included an absorption lag .
CONCLUSIONS	Weight was predictive of exposure for both AZ and CQ .
CONCLUSIONS	Assuming equivalent dosing ( mg/kg ) , AZ and CQ exposure in children would be expected to be lower than that in adults , suggesting that children may require a higher dose ( mg/kg ) than adults to achieve the same AZ and CQ exposure .

###24383121
OBJECTIVE	In the SAVE-trial we evaluated the safety , reliability and improvements of patient management using the BIOTRONIK Home Monitoring-System ( HM ) in pacemaker ( PM ) and implanted cardioverter defibrillator ( ICD ) patients .
METHODS	115 PM ( Module A ) and 36 ICD-patients ( Module B ) were recruited 3 months after implantation .
METHODS	65 patients in Module A were randomised to HM-OFF and had one scheduled outpatient clinic follow-up ( FU ) per year , whereas patients randomised to HM-ON were equipped with the mobile transmitter and discharged without any further scheduled in-office FU .
METHODS	In Module B 18 patients were randomised to HM-OFF and followed by standard outpatient clinic controls every 6 months ; 18 patients were randomised to HM-ON receiving remote monitoring plus one outpatient clinic visit per year ; unscheduled follow-ups were performed when necessary .
RESULTS	The average follow-up period was 17.1 9.2 months in Module A and 26.3 8.6 months in Module B.
RESULTS	In both modules , the number of FUs per year was significantly reduced ( Module A HM-ON 0.29 0.6 FUs/year vs HM-OFF 0.53 0.5 FUs/year ; p b 0.001 ; Module B HM-ON 0.87 0.25 vs HM-OFF 1.73 0.53 FU/year , p b 0.001 ) .
RESULTS	Cost analysis was significantly lower in the HM-ON group compared to the HM-OFF group ( 18.0 41.3 and 22.4 26.9 respectively ; p b 0.003 ) .
RESULTS	93 % of the unscheduled visits in Module B were clinically indicated , whereas 55 % of the routine FUs were classified as clinically unnecessary .
CONCLUSIONS	Remote home monitoring of pacemaker and ICD devices was safe , reduced overall hospital visits , and detected events that mandated unscheduled visits .

###25372149
OBJECTIVE	This study is designed to address the need for evidence-based HIV/STI prevention approaches for drug-involved women under criminal justice community supervision .
OBJECTIVE	We tested the efficacy of a group-based traditional and multimedia HIV/STI prevention intervention ( Project WORTH : Women on the Road to Health ) among drug-involved women under community supervision .
METHODS	We randomized 306 women recruited from community supervision settings to receive either : ( 1 ) a four-session traditional group-based HIV/STI prevention intervention ( traditional WORTH ) ; ( 2 ) a four-session multimedia group-based HIV/STI prevention intervention that covered the same content as traditional WORTH but was delivered in a computerized format ; or ( 3 ) a four-session group-based Wellness Promotion intervention that served as an attention control condition .
METHODS	The study examined whether the traditional or multimedia WORTH intervention was more efficacious in reducing risks when compared to Wellness Promotion ; and whether multimedia WORTH was more efficacious in reducing risks when compared to traditional WORTH .
METHODS	Primary outcomes were assessed over the 12-month post-intervention period and included the number of unprotected sex acts , the proportion of protected sex acts , and consistent condom use .
METHODS	At baseline , 77 % of participants reported unprotected vaginal or anal sex ( n = 237 ) and 63 % ( n = 194 ) had multiple sex partners .
RESULTS	Women assigned to traditional or multimedia WORTH were significantly more likely than women assigned to the control condition to report an increase in the proportion of protected sex acts ( = 0.10 ; 95 % CI = 0.02-0 .18 ) and a decrease in the number of unprotected sex acts ( IRR = 0.72 ; 95 % CI = 0.57-0 .90 ) .
CONCLUSIONS	The promising effects of traditional and multimedia WORTH on increasing condom use and high participation rates suggest that WORTH may be scaled up to redress the concentrated epidemics of HIV/STIs among drug-involved women in the criminal justice system .
BACKGROUND	ClinicalTrials.gov NCT01784809 .

###24323034
OBJECTIVE	Ligand-mediated activation of the androgen receptor ( AR ) is critical for prostate cancer ( PCa ) survival and proliferation .
OBJECTIVE	The failure to completely ablate tissue androgens may limit suppression of PCa growth .
OBJECTIVE	We evaluated combinations of CYP17A and 5 -- reductase inhibitors for reducing prostate androgen levels , AR signaling , and PCa volumes .
METHODS	Thirty-five men with intermediate/high-risk clinically localized PCa were randomly assigned to goserelin combined with dutasteride ( ZD ) , bicalutamide and dutasteride ( ZBD ) , or bicalutamide , dutasteride , and ketoconazole ( ZBDK ) for 3 months before prostatectomy .
METHODS	Controls included patients receiving combined androgen blockade with luteinizing hormone-releasing hormone agonist and bicalutamide .
METHODS	The primary outcome measure was tissue dihydrotestosterone ( DHT ) concentration .
RESULTS	Prostate DHT levels were substantially lower in all experimental arms ( 0.02 to 0.04 ng/g v 0.92 ng/g in controls ; P < .001 ) .
RESULTS	The ZBDK group demonstrated the greatest percentage decline in serum testosterone , androsterone , and dehydroepiandrosterone sulfate ( P < .05 for all ) .
RESULTS	Staining for AR and the androgen-regulated genes prostate-specific antigen and TMPRSS2 was strongly suppressed in benign glands and moderately in malignant glands ( P < .05 for all ) .
RESULTS	Two patients had pathologic complete response , and nine had 0.2 cm ( 3 ) of residual tumor ( defined as a near-complete response ) , with the largest numbers of complete and near-complete responses in the ZBDK group .
CONCLUSIONS	Addition of androgen synthesis inhibitors lowers prostate androgens below that achieved with standard therapy , but significant AR signaling remains .
CONCLUSIONS	Tissue-based analysis of steroids and AR signaling is critical to informing the search for optimal local and systemic control of high-risk prostate cancer .

###24281754
BACKGROUND	This prospective registry assessed the safety and efficacy of paclitaxel coated balloon ( PCB ) angioplasty for small vessel coronary artery disease in Europe and Asia with the intention to treat lesions without additional stenting .
BACKGROUND	The use of PCBs in small vessels seems to be associated with favourable outcomes ; however , prospective data for the use of PCBs without stenting are limited .
METHODS	The SeQuent Please Small Vessel ` PCB only ' Registry was an international , prospective , multicentre registry enrolling patients with de novo lesions of small reference diameters ( 2.0 mm , 2.75 mm ) .
METHODS	The primary end point was clinically driven target lesion revascularisation ( TLR ) at 9 months .
METHODS	Secondary end points were acute technical success , in-hospital outcomes , 9-month major adverse cardiac events ( MACE ) ( death , myocardial infarction , or TLR ) , and the occurrence of definite lesion and vessel thrombosis .
RESULTS	A total of 479 patients ( 66.1 10.9 years , 36.7 % diabetics ) were enrolled , 105 ( 23.5 % ) with an acute coronary syndrome , 41 ( 9.2 % ) with ST elevation myocardial infarction ( STEMI ) , and 60 ( 14.8 % ) with non-STEMI .
RESULTS	The initial procedural success rate was 99.0 % ; 27 patients ( 6 % ) needed additional bare metal stent implantation .
RESULTS	TLR at 9.41.7 months occurred in 14 patients ( 3.6 % ) , while three patients ( 0.6 % ) had vessel thrombosis in non-target lesions .
RESULTS	There was no cardiac death or coronary artery bypass graft surgery .
CONCLUSIONS	To date , this is the largest prospective study with PCBs in small vessel de novo lesions in unselected patients .
CONCLUSIONS	Rates of TLR and MACE were low , suggesting the use of PCBs may be an attractive alternative treatment option to drug eluting stents in small vessels .

###24628042
BACKGROUND	This study aimed to determine the safety and efficacy of intraoperative intensive glycaemic treatment with modified glucose-insulin-potassium solution by hyperinsulinemic normoglycaemic clamp in cardiopulmonary bypass surgery patients .
BACKGROUND	We hypothesised that the treatment would reduce infection rates in this group of patients .
METHODS	A prospective , randomised , double-blind trial was conducted in cardiopulmonary bypass surgery patients .
METHODS	A total of 199 adult patients ( out of a planned 400 ) were randomly allocated to intensive or conventional treatment with target glucose levels of 4.4-8 .3 mmol/l and < 13.8 mmol/l , respectively .
METHODS	The primary outcomes were clinical infection and cytokine levels , including interleukin ( IL ) -6 and IL-10 .
METHODS	The secondary outcomes were morbidity and mortality .
RESULTS	The study was terminated early because of safety concerns ( hypoglycaemia ) .
RESULTS	The clinical post-operative infection rate was 17 % in the intensive group and 13 % in the conventional group ( P = 0.53 ) .
RESULTS	The proportion of patients with hypoglycaemia was significantly higher in the intensive group ( 23 % ) compared with the conventional group ( 3 % ) ( P < 0.001 ) .
RESULTS	Morbidity and mortality rates were similar for both groups .
RESULTS	Anaesthetic duration > 2 h ( vs. 2 h ) , pre-operative IL-6 level > 15 pg/ml ( vs. 15 pg/ml ) and post-operative IL-6 level 56-110 pg/ml ( vs. 55 pg/ml ) were independent predictors for post-operative infection .
CONCLUSIONS	Intraoperative intensive glycaemic treatment significantly increased the risk of hypoglycaemia , but its effect on post-operative infection by clinical assessment could not be determined .
CONCLUSIONS	Anaesthetic duration , pre-operative and post-operative IL-6 levels can independently predict post-operative infection .

###24237691
BACKGROUND	Preclinical and clinical trials suggest that yohimbine may augment extinction learning without significant side effects .
BACKGROUND	However , previous clinical trials have only examined adults with specific phobias .
BACKGROUND	Yohimbine has not yet been investigated in the augmentation of exposure therapy for other anxiety disorders .
METHODS	Adults ( n = 40 ) with a DSM-IV diagnosis of social anxiety disorder were randomized to placebo or yohimbine HCl ( 10.8 mg ) 1 hour before each of four exposure sessions .
METHODS	Outcome measures were collected at baseline , each treatment session , posttreatment , and 1-month follow-up .
RESULTS	Yohimbine was well tolerated .
RESULTS	Yohimbine augmentation , relative to placebo augmentation , resulted in faster improvement and better outcomes on self-report measures of social anxiety disorder severity ( Liebowitz Social Anxiety Scale , d = .53 ) and depressed mood severity ( Beck Depression Inventory , d = .37 ) but not on the clinician-rated measures ( Clinical Global Impressions-Severity Scale , d = .09 ; Clinical Global Impressions-Improvement Scale , d = .25 ) .
RESULTS	Between-group differences on the Liebowitz Social Anxiety Scale were moderated by the level of fear reported at the end of an exposure exercise ( end fear ) , such that the advantage of yohimbine over placebo was only evident among patients who reported low end fear .
CONCLUSIONS	The results provide moderate support for yohimbine as a therapeutic augmentation strategy for exposure therapy in social anxiety disorder , one that may be especially effective when coupled with successful exposure experiences .
CONCLUSIONS	Beneficial effects for yohimbine were readily evident for self-report measures but not for clinician-rated outcomes of social anxiety severity and improvement .

###25130629
OBJECTIVE	The aim of this study was to evaluate the effect of long-term administration of liquid nutritional supplement with increased amounts of whey protein and reduced amounts of lactose , produced in accordance with a new recipe `` Nutrisen '' on the elderly living in institutionalized care .
METHODS	The study was carried out from May to July , 2013 , on 47 retirement home residents , living in Prague , all of which were 65 years or older .
METHODS	Supplemented group ( n = 23 ) consumed ( 200 ml ) milk drinks with three different flavours on a daily basis for eight weeks .
METHODS	The reference group was on a normal diet .
METHODS	There was no significant difference in baseline characteristics between participants in both groups .
METHODS	Anthropometric and biochemical indicators of nutritional status and tolerance of the nutritional supplement during long-term use were evaluated .
RESULTS	Both compliance ( daily intake program ) and tolerance of the nutritionally defined supplement were very good .
RESULTS	For the supplemented group , there was an average weight increased of 700 grams after the 8 week nutritional supplement test period .
RESULTS	Average levels of albumin and prealbumin increased significantly ( from the beginning to the end of the program ) , 35.5 4.52 g/l vs 36.19 4.1 g/l and 0.160 0.05 vs 0.174 0.04 g/l ( p < 0.05 ) , vitamin D levels increased from 31.2 16.4 nmol/l to 36.8 17.7 nmol/l ( p < 0.001 ) and HDL-cholesterol levels increased from 1.29 0.33 mmol/l to 1.35 0.35 mmol/l ( p < 0.001 ) .
CONCLUSIONS	The specific nutritionally defined milk drink ( Nutrisen ) , used in this study , was well tolerated by the elderly study participants , over the eight-week clinical study .
CONCLUSIONS	We observed a positive effect on the participants weight , serum albumin , prealbumin , vitamin D and HDL-cholesterol .

###25919834
BACKGROUND	Insight into delusional beliefs varies in patients with major depressive disorder ( MDD ) with psychotic features ( `` psychotic depression '' ) .
BACKGROUND	The relationship between impaired insight and illness severity and its impact on treatment outcomes has not been studied in psychotic depression .
BACKGROUND	As such , the aim of this analysis was to explore the relationship among impaired insight , patient characteristics ( ie , illness severity , cognition , suicidality , and social functioning ) , and treatment outcome ( ie , remission ) during acute treatment of psychotic depression .
METHODS	This secondary analysis is based on the data from the Study of Pharmacotherapy for Psychotic Depression ( STOP-PD ) in which 259 participants meeting DSM-IV criteria for MDD with psychotic features enrolled between December 2002 and June 2007 ( including 142 aged 60 years ) in a 4-center , 12 - week , double-blind , randomized controlled trial funded by the US National Institutes of Health .
METHODS	Insight into delusions was assessed using the Delusion Assessment Scale ( DAS ) .
METHODS	The primary outcomes were the predictive utility of insight into illness ( ie , Hamilton Depression Rating Scale [ HDRS ] insight item ) and insight into delusions ( conviction factor derived from the DAS ) on final treatment outcome at 12 weeks of treatment ( ie , full remission , partial remission , and nonremission ) .
RESULTS	At baseline , impaired insight into delusions was positively associated with illness severity ( HDRS-16 which excluded the insight item , r = 0.15 , P = .016 ) and negatively correlated with measures of cognition ( P < .05 ) .
RESULTS	Improvement in insight was not associated with changes in cognition , suicidality , or social functioning after adjusting for covariates .
RESULTS	Independent of the severity of depression or psychosis , impaired insight into delusions at baseline ( = 11.65 , P = .020 ) and after 3 ( = 9.62 , P = .047 ) , 6 ( = 6.97 , P = .031 ) , and 8 ( = 9.08 , P = .011 ) weeks of treatment predicted remission at the end of the trial .
CONCLUSIONS	Impaired insight into delusions appears to be an independent predictor of remission in MDD with psychotic features during acute treatment , suggesting that more attention should be paid to this symptom .
CONCLUSIONS	Longitudinal studies are required to determine the impact of impaired insight into delusions on long-term outcomes , including relapse .
BACKGROUND	ClinicalTrials.gov identifier : NCT00056472 .

###25293388
BACKGROUND	Therapy-induced mucositis and dysphagia puts head and neck ( H&N ) cancer patients at increased risk for developing cachexia .
BACKGROUND	Omega-3 fatty acids ( n-3 FA ) have been suggested to protect against cachexia .
BACKGROUND	We aimed to examine if echium oil , a plant source of n-3 FA , could reduce weight loss in H&N cancer patients undergoing radio ( chemo ) therapy with curative intent .
METHODS	In a double-blind trial , patients were randomly assigned to echium oil ( intervention ( I ) group ; 7.5 ml bis in die ( b.i.d. ) , 235 mg/ml - linolenic acid ( ALA ) + 95 mg/ml stearidonic acid ( SDA ) + 79 mg/ml - linolenic acid ( GLA ) ) or n-3 FA deficient sunflower oil high oleic ( control ( C ) group ; 7.5 ml b.i.d. ) additional to standard nutritional support during treatment .
METHODS	Differences in percentage weight loss between both groups were analysed according to the intention-to-treat principle .
METHODS	Erythrocyte FA profile , body composition , nutritional status and quality of life were collected .
RESULTS	Ninety-one eligible patients were randomised , of whom 83 were evaluable .
RESULTS	Dietary supplement adherence was comparable in both groups ( median , I : 87 % , C : 81 % ) .
RESULTS	At week 4 , the I group showed significantly increased values of erythrocyte n-3 eicosapentanoic acid ( EPA , 14 % vs -5 % ) and n-6 GLA ( 42 % vs -20 % ) compared to the C group , without a significant change in n-6 arachidonic acid ( AA , 2 % vs -1 % ) .
RESULTS	Intention-to-treat analysis could not reveal a significant reduction in weight loss related to echium oil consumption ( median weight loss , I : 8.9 % , C : 7.6 % ) .
RESULTS	Also , no significant improvement was observed in the other evaluated anthropometric parameters .
CONCLUSIONS	Echium oil effectively increased erythrocyte EPA and GLA FAs in H&N cancer patients .
CONCLUSIONS	It failed however to protect against weight loss , or improve nutritional parameters .
BACKGROUND	ClinicalTrials.gov Identifier NCT01596933 .

###25240629
OBJECTIVE	To evaluate the expression of matrix metalloproteinase 9 ( MMP9 ) and transglutaminase 2 ( TG2 ) in different forms of dry eye .
METHODS	Case control study .
METHODS	Seventy-five female subjects divided into 3 groups : group 1 , 15 healthy controls ; group 2 , 30 subjects with Sjgren syndrome ( SS ) ; and group 3 , 30 subjects with Meibomian gland dysfunction ( MGD ) .
METHODS	A clinical assessment was carried out and impression cytologic specimens were processed for immunoperoxidase staining for MMP9 and TG2 and real-time polymerase chain reaction analyses were carried out for MMP9 , TG2 , interleukin-6 , interferon - , B-cell lymphoma 2 , and caspase 3 .
METHODS	To study MMP9 and TG2 expression after anti-inflammatory treatment , patients were divided into 2 subgroups , one treated with saline and the other treated with saline plus topical corticosteroid eye drops ( 0.5 % loteprednol etabonate ) 4 times daily for 15 days .
METHODS	For statistical analysis , Student t test , Mann-Whitney U test , and Spearman 's correlation coefficient were used as appropriate .
METHODS	Conjunctival expression of MMP9 and TG2 .
RESULTS	MMP9 and TG2 expression were higher in both patient groups than in controls ( P < 0.0001 ) .
RESULTS	Group 2 patients showed higher expression than group 3 ( P < 0.0001 ) .
RESULTS	The Spearman 's correlation coefficient showed in group 2 a positive correlation between MMP9 and TG2 expression ( = 0.437 ; P = 0.01 ) , but no correlation in group 3 ( = 0.143 ; P = 0.45 ) .
RESULTS	Corticosteroid treatment significantly reduced MMP9 and TG2 expression in both groups , ameliorating symptoms and signs .
RESULTS	A much higher percentage reduction was observed in SS .
CONCLUSIONS	The pathogenic mechanisms of the 2 forms of dry eye give an account for the different MMP9 and TG2 expressions in the 2 groups of patients .
CONCLUSIONS	The higher expression in SS is determined by the direct autoimmune insult to the ocular surface epithelia , whereas in MGD patients , with an epithelial damage due to an unbalanced tear secretion , the molecules expression is significantly lower , although higher than in controls .
CONCLUSIONS	The corticosteroid treatment induced a reduction of both molecules , although higher in SS than in MGD , because of its direct inhibitory effect on inflammation .

###25011384
BACKGROUND	Few studies have examined the differential effects of weight management by exercise mode on subclinical atherosclerosis .
BACKGROUND	We hypothesized that 3 modes of aerobic , resistance , and combination exercises have differential effects on the flow-mediated dilation ( FMD ) , carotid-femoral pulse wave velocity ( PWV ) , and carotid intima-media thickness ( IMT ) as well as cardiometabolic profile in weight management .
METHODS	A randomized , single-blind trial ( ISRCTN46069848 ) was conducted in Seoul , South Korea between November 2011 and December 2012 .
METHODS	Randomized participants were 110 women with abdominal obesity ( aerobic group n = 50 ; resistance group n = 30 ; combination exercise group n = 30 ) .
METHODS	The treatment period was 12 months with 3-month follow up : A diet-alone intervention for the first 3 months and a diet-plus-exercise intervention for the next 9 months according to exercise modes .
METHODS	The exercise training was designed with an intensity of 50-70 % heart rate reserve for 3 days a week in 60-minute-long sessions for 9 months , consisting of 30-minute treadmill and 30-minute bike exercises for aerobic group ; upper and lower body exercises with an intensity target of 2 sets and 8-12 repetitions for resistance group ; 30-minute resistance and consecutive 30-minute aerobic exercises for combination group .
RESULTS	Ninety-two and 49 participants were analyzed for modified intention-to-treat analysis and per-protocol ( PP ) analysis , respectively .
RESULTS	The 3 exercise modes had no significant differential effects on FMD , PWV , and IMT over time ; however , the combination group was found to have significantly lower levels of fasting glucose than the aerobic group ( p = .034 ) in the PP analysis .
RESULTS	Nevertheless , we observed significant time effects such as reductions in PWV ( p = .048 ) and IMT ( p = .018 ) in cubic and quadratic trends , respectively , and improvements in body weight , waist circumference , low-density and high-density lipoprotein cholesterol levels , fasting glucose levels , and cardiorespiratory fitness in linear , quadratic , or cubic trends .
CONCLUSIONS	For women with abdominal obesity , a combination of aerobic and resistance exercises may be preferable to a single exercise mode for effective glucose control .
CONCLUSIONS	Regardless of exercise mode , exercise interventions combined with dietary interventions in weight management may be beneficial in reducing the risk of subclinical atherosclerosis and cardiometabolic risk .

###25267326
OBJECTIVE	We recently completed a randomized controlled trial of an endoscopic quality improvement program ( EQUIP ) that demonstrated an improved adenoma detection rate ( ADR ) through simple educational interventions .
OBJECTIVE	The aim of this study ( phase III ) is to examine whether the improvement in ADR in the trained endoscopists remained stable with further follow-up .
METHODS	We prospectively followed up 15 staff endoscopists who had previously been randomized to a quality improvement intervention .
METHODS	In the current study , we examined an additional 1,200 colonoscopy procedures conducted over a 5-month time period following the original study , referred to as phase III .
METHODS	During this time , all physicians received quarterly ADR and other quality metric feedback , and the previous control group was offered the educational intervention voluntarily .
METHODS	ADRs and adenoma per patient ( APP ) rates were estimated in the endoscopists who were and were not randomized to EQUIP training and compared with those obtained in phases I and II of the original study .
METHODS	The study was conducted in a tertiary care Academic Medical Center .
METHODS	The study sample comprised 1200 patients undergoing routine colonoscopy .
METHODS	The main outcome measurement was adenoma detection rate .
RESULTS	The previously observed increase in ADR in the trained group from 36 % in phase I to 47 % in phase II was maintained into phase III ( 46 % ) .
RESULTS	The ADR of the untrained group remained unchanged from phase I ( 36 % ) to phase II ( 35 % ) ; it was increased only marginally in phase III to 39 % , which was still lower than the 46 % ADR in the trained group .
RESULTS	The trained group had an increase in APP , from 0.72 in Phase I to 0.87 in Phase II and 0.98 in Phase III .
RESULTS	For the previously untrained group , there was no change in APP from phase I ( 0.68 ) to phase II ( 0.68 ) , but there was possibly a small increase ( to 0.74 ) in Phase III .
CONCLUSIONS	This study provides evidence that improvements in ADR obtained through the endoscopic quality-training program can persist for at least 5 months after completion of the program .
CONCLUSIONS	It further suggests that a focus on ADR does not lead to a `` one and done '' phenomenon .
CONCLUSIONS	The limitations of this study were as follows : single-center setting , and lack of sessile polyp information/standardization .

###25355261
OBJECTIVE	To evaluate the condition of cancer-related fatigue ( CRF ) in breast cancer patients with chemotherapy and to explore the effect of Yoga on it .
METHODS	After the completion of Yoga , 100 breast cancer patients with CRF ( CFS > 0 ) were selected and were randomly divided into the Yoga group and the control group ( n = 50 ) .
METHODS	Patients in the control group only received routine cure and care while patients in the Yoga group received extra Yoga exercise , lasting for 4 months .
METHODS	Cancer fatigue scale ( CFS ) was evaluated in the 2nd , 4th and 6th round of chemotherapy .
RESULTS	At the end , 82 cases qualified for the study , 42 cases for the control group and 40 for the Yoga group .
RESULTS	The mean score of body fatigue was 12.673.46 .
RESULTS	There was no significant difference in CRF between the Yago group and the control group before the Yoga intervention ( P > 0.05 ) .
RESULTS	After the 4th round of chemotherapy , the mean scores of CFS and body fatigue in the Yoga group were significantly lower than that in the control group ( P < 0.05 ) .
RESULTS	After the 6th round of chemotherapy , the mean scores of CFS , body fatigue and cognitive fatigue in the Yoga group were lower than that in the control group ( P < 0.05 ) .
RESULTS	Repeated analysis of variance showed that the difference in the overall fatigue , body fatigue and cognitive fatigue between the Yoga group and the control group was significant ( P < 0.05 ) ; the time influence on the overall fatigue , body fatigue and emotional fatigue was significant difference between the 2 groups ( P < 0.05 ) ; there were interactions between the effect of Yago and time on the overall fatigue , body fatigue and cognitive fatigue ( P < 0.05 ) .
CONCLUSIONS	The body fatigue was more serious in breast cancer patients with chemotherapy .
CONCLUSIONS	Yoga intervention could significantly reduce body fatigue , cognitive fatigue , thus reduce the overall fatigue in breast cancer patients with chemotherapy .

###25348255
BACKGROUND	To assess the efficacy and safety of LY500307 , a selective estrogen receptor beta agonist , on lower urinary tract symptoms ( LUTS ) in patients with enlarged prostate secondary to BPH .
METHODS	In a randomized , double-blind , placebo-controlled , parallel phase 2 , efficacy and safety study , eligible patients with moderate to severe LUTS and prostatic enlargement ( 30ml ) were randomized to placebo or LY500307 at 1 , 3 , 10 and 25mg once daily for 24 weeks .
METHODS	Primary efficacy end point was change in total International Prostate Symptoms Score ( IPSS ) after 24 weeks .
METHODS	Secondary end points included changes in total prostate volume ( TPV ) that served as a proof of concept end point , as well as IPSS quality of life , maximum peak urine flow rate ( Qmax ) and PSA and safety ( adverse events , laboratory test ) .
RESULTS	A total of 414 patients were randomized when the study was terminated because of insufficient TPV reduction , based on a priori defined interim analysis .
RESULTS	The IPSS mean change from baseline to end point was -3.46.8 in the placebo group and -1.36.6 , -2.67.0 , -3.76.7 and -4.45.7 in the 1 , 3 , 10 and 25mg LY500307-treated groups , respectively ( P > 0.05 ) .
RESULTS	Similarly , no treatment effect was observed for any of the secondary efficacy measures .
RESULTS	Incidence of adverse events was comparable between treatment groups , and no clinically meaningful changes in laboratory tests were observed .
CONCLUSIONS	LY500307 was well tolerated in BPH patients with LUTS at doses up to 25mg once daily for 24 weeks .
CONCLUSIONS	The study was terminated early because of inadequate efficacy .

###24717626
BACKGROUND	Phosphodiesterase-5 ( PDE5 ) inhibitors improve exercise capacity and quality of life in patients with idiopathic pulmonary arterial hypertension .
BACKGROUND	However , whether such beneficial effects take place in selected populations with chronic obstructive pulmonary disease ( COPD ) remains uncertain .
BACKGROUND	We aimed to assess the effects of tadalafil -- a PDE5 inhibitor -- on exercise capacity and quality of life in patients with COPD and mild pulmonary hypertension .
METHODS	We did a randomised , double-blind , parallel-group , placebo-controlled trial at three centres in Scotland , UK , between Sept 1 , 2010 , and Sept 1 , 2012 .
METHODS	Patients with moderate to severe COPD were randomly assigned ( 1:1 ) , via centralised randomisation with a computer-generated sequence and block sizes of four , to receive daily tadalafil 10 mg or placebo for 12 weeks .
METHODS	Patients , study investigators , outcome assessors , and those administering drugs were masked to group allocation .
METHODS	The primary endpoint was the mean placebo-corrected difference between the baseline and final 6 min walk distance after 12 weeks .
METHODS	We measured change in quality of life at baseline , 8 weeks , and 12 weeks , with standardised questionnaires .
METHODS	Analysis was per protocol and by intention to treat .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01197469 .
RESULTS	120 patients were randomly assigned to receive tadalafil ( n = 60 ) or placebo ( n = 60 ) , of whom 56 ( 93 % ) versus 57 ( 95 % ) completed the study .
RESULTS	At 12 weeks the difference in 6 min walking distance between the tadalafil and placebo groups was 05 m ( 95 % CI -116 to 125 ; p = 0937 ) .
RESULTS	We recorded no statistically significant changes in quality of life ( between-group difference on the St George 's Respiratory Questionnaire -264 [ 95 % CI -643 to 115 ] ; Research and Development version 1 short-form-36 408 [ -135 to 952 ] ; Minnesota Living with Heart Failure questionnaire -231 [ -706 to 245 ] ) .
RESULTS	19 ( 32 % ) of 60 patients in the treatment group had dyspepsia ; the severity of dyspepsia ranged from mild to severe , with four ( 21 % ) of 19 patients needing a proton-pump inhibitor .
RESULTS	Five ( 8 % ) of 60 participants had dyspepsia in the placebo group .
RESULTS	Headache was noted in 17 ( 28 % ) patients in the treatment group versus 5 ( 8 % ) in the placebo group , but was mild in all patients .
RESULTS	Two ( 3 % ) patients in the treatment group had facial flushing , which resulted in one withdrawal .
RESULTS	Other withdrawals within the tadalafil group happened after a transient ischaemic attack and two deaths ( ruptured abdominal aortic aneurysm and pneumonia ) .
CONCLUSIONS	Tadalafil does not improve exercise capacity or quality of life despite exerting pulmonary vasodilation .
BACKGROUND	Chief Scientist Office for Scotland .

###24349598
BACKGROUND	Dysregulated immune responses may contribute to the clinical complications that occur in some patients with dengue .
RESULTS	In Vietnamese pediatric dengue cases randomized to early prednisolone therapy , 81 gene-transcripts ( 0.2 % of the 47,231 evaluated ) were differentially abundant in whole-blood between high-dose ( 2 mg/kg ) prednisolone and placebo-treated patients two days after commencing therapy .
RESULTS	Prominent among the 81 transcripts were those associated with T and NK cell cytolytic functions .
RESULTS	Additionally , prednisolone therapy was not associated with changes in plasma cytokine levels .
CONCLUSIONS	The inability of prednisolone treatment to markedly attenuate the host immune response is instructive for planning future therapeutic strategies for dengue .

###26176061
OBJECTIVE	Recent clinical trials suggested that abdominal drainage is not needed in all cases and should be restricted in patients with chronic liver disease or patients who underwent minor liver resection .
OBJECTIVE	In this study we conducted a randomized study to determine whether abdominal drainage is beneficial or rather hazardous after hepatic resection .
METHODS	Two hundred consecutive patients undergoing elective hepatectomy were entered for this prospective , randomized , case-controlled study .
METHODS	Liver resection was performed under intermittent Pringle maneuver .
METHODS	Clinical data such as postoperative complications and mortality rates were evaluated as well as intraoperative parameters .
RESULTS	There were no significant differences in postoperative morbidity between with and without abdominal drainage groups 16 vs. 12 % ) .
RESULTS	However , complications directly related no drainage such as drain site bleeding and infection , abdominal abscess , bile fistula , and ascites ( CDRD ) tended to be higher in the drainage group than the no-drainage group ( 9 vs. 3 % , p = 0.067 ) .
RESULTS	Particularly , there was high incidence of CDRD in the drainage group compared with the no drainage group in patients with chronic liver diseases ( 13.2 vs. 1.8 % , p = 0.027 ) .
CONCLUSIONS	We do not recommend systematic drainage after elective hepatectomy , irrespective of the extent of resection and of the underlying liver diseases when the surgical procedure has been satisfactory .

###24462464
OBJECTIVE	Adding nitroglycerin to the combination of vinorelbine plus cisplatin has been reported to improve the overall survival ( OS ) of Asian patients with stage IIIB/IV non-small cell lung cancer ( NSCLC ) probably due to better drug delivery based on changed vascular tonus .
OBJECTIVE	The main objective of our study was to evaluate the effect of adding nitroglycerin to vinorelbine and cisplatin in a Caucasian population .
METHODS	66 chemonave patients with stage IIIB/IV NSCLC received oral vinorelbine ( first cycle 60 mg/m ( 2 ) , subsequent cycles : 80 mg/m ( 2 ) in the absence of any hematological toxicity grade 3 in cycle 1 ) once daily on days 1 and 8 of each cycle and cisplatin ( 80 mg/m ( 2 ) i.v. ) on day 1 of each cycle ( q3w ) .
METHODS	Nitroglycerin ( arm A , n = 34 ) or placebo patches ( arm B , n = 32 ) were administered once daily from day -3 to day 2 of each cycle and were removed about 12h after administration .
METHODS	One nitroglycerin patch contained 25mg nitroglycerin .
RESULTS	Median age was 62.5 ( 33-82 ) years .
RESULTS	In the overall population ( n = 66 ) , the objective response rate ( ORR ) was 27.3 % ( all PR ; 95 % CI : 17.0-39 .6 ) , with a disease control rate ( DCR ) of 57.6 % ( 95 % CI : 44.8-69 .7 ) , a median time to progression ( TTP ) of 4.8 months ( n = 58 ; 95 % CI : 3.4-5 .9 ) and a median overall survival ( OS ) of 11.5 months ( 95 % CI : 7.9-13 .6 ) .
RESULTS	ORR and DCR were numerically higher in arm A than in arm B ( 35.3 % vs. 18.8 % and 61.8 % vs. 53.1 % , respectively ) , whereas TTP and OS were comparable .
RESULTS	The main hematological and non-hematological toxicities grade 3 were moderate with no significant differences between the two treatment arms .
CONCLUSIONS	Overall , oral vinorelbine plus cisplatin showed a high level of efficacy and adequate tolerability in first line treatment of NSCLC .
CONCLUSIONS	Despite the low sample size per group the results seem to confirm the previous results reported in Asian patients .

###25050884
OBJECTIVE	An inability to show consistent relationships between gene variants and blood pressure ( BP ) may be confounded by the use of office BP measurement .
OBJECTIVE	Whether the difference between office BP and day BP ( office-day ) is genetically predetermined is unknown .
OBJECTIVE	We therefore aimed to determine the intrafamilial aggregation and heritability of office-day BP .
METHODS	Nurse-derived office BP ( mean of 5 measurements according to guidelines ) and 24-h ambulatory BP were determined for 592 participants from 198 families ( 67 spouse pairs , 361 parent-child pairs , and 169 sibling-sibling pairs ) , with 12 families having three generations , from an urban developing community of black Africans .
METHODS	Heritability estimates were determined using SAGE software .
RESULTS	With adjustments for confounders , office systolic BP ( SBP ) ( h = 0.350.09 , P < 0.0001 ) showed comparable heritability estimates to 24-h SBP ( h = 0.330.09 , P < 0.0001 ) .
RESULTS	Similarly , with adjustments for confounders , office diastolic BP ( DBP ) ( h = 0.370.09 , P < 0.0001 ) showed comparable heritability estimates as 24-h DBP ( h = 0.350.09 , P < 0.0001 ) .
RESULTS	However , multivariate adjusted heritability estimates of day SBP ( h = 0.290.09 , P < 0.0001 ) and DBP ( h = 0.330.09 , P < 0.0001 ) were not diminished by further adjustments for office SBP ( h = 0.420.09 , P < 0.0001 ) or DBP ( h = 0.340.09 , P < 0.0001 ) .
RESULTS	Further , independent of confounders , office-day BP showed significant intrafamilial aggregation and heritability ( SBP : h = 0.510.10 , P < 0.0001 ; DBP : h = 0.370.09 , P < 0.0001 ) , effects that persisted with further adjustments for office , day , or day-night BP ( P < 0.0005 for SBP and DBP ) .
CONCLUSIONS	Although office and ambulatory BP may show similar heritability estimates , genetic associations with carefully determined office BP measurements may be confounded by the heritability of office-day BP differences .

###24837026
OBJECTIVE	To establish if women obtain any measurable short term psychological benefit or perceived benefit from having a test to determine the probability of their pregnancy being on-going when this is uncertain on ultrasound examination .
METHODS	This was a prospective randomised controlled study conducted January 2012-June 2012 at the EPU of King 's College Hospital .
METHODS	The study population was women who conceived spontaneously and had a single intrauterine gestational sac of < 20mm mean diameter , with no visible embryo on their first ultrasound scan .
METHODS	Eligible women were randomised to have a test to calculate the probability of viability ( cases ) or not ( controls ) .
METHODS	Depression and anxiety levels were calculated using the Hospital Anxiety and Depression Score ( HADS ) and were performed prior to randomisation and seven days later .
METHODS	A repeat scan for pregnancy outcome was performed after one to two weeks as clinically indicated .
METHODS	A sample size of 69 in each group was calculated to have 80 % power to detect a probability of 0.362 that an observation in the cases was less than an observation in controls using a Wilcoxon Mann-Whitney rank-sum test with a 0.05 two-sided significance .
RESULTS	At recruitment there was no significant difference in anxiety levels between cases and controls .
RESULTS	After seven days anxiety levels were significantly lower in cases than controls ( p = 0.04 ) .
RESULTS	Of those who received the probability score , 55/70 ( 78.6 % 95 % CI 67.5-86 .7 % ) found it useful and 58/70 ( 82.9 % 95 % CI 72.2-90 .1 ) would choose to have the test in a future pregnancy if indicated .
CONCLUSIONS	This study has demonstrated that there is evidence of psychological benefit from a simple blood test that gives women the likelihood that their pregnancy will be on-going at the next scan .

###25175981
BACKGROUND	The addition of a DDP4-inhibitor to existing insulin therapy reduces HbA1c .
BACKGROUND	However , no data exist about the addition of these agents at the beginning of insulin treatment in type 2 diabetes while this could especially be interesting because it is during this period that considerable residual beta cell function is still present .
BACKGROUND	The benefit of such a strategy could be a lower insulin dose required for glycemic control .
BACKGROUND	The hypothesis of our study was that adding a DPP4-inhibitor at the beginning of insulin treatment could lead to less exogenous insulin requirement , a reduction of hyperinsulinemia and side effects ( hypoglycemia and weight gain ) , less glucose variability and improvement of insulin and glucagon dynamics during a mixed meal test .
RESULTS	In this small clinical trial ( trial registration NTR2022 ) 9 patients were randomized to receive vildagliptin and 6 to receive placebo in addition to start of once daily insulin treatment .
RESULTS	Unfortunately , due to a difficult inclusion , the preset sample size of 40 patients could not be met .
RESULTS	Median units of insulin at the end of the study was 47 U in the placebo group and 34 U in the vildagliptin group .
RESULTS	Median glycemic variability ( SD ) at the end of study was 2.1 in the placebo group and 1.5 in the vildagliptin group .
RESULTS	Median weight gain at the end of study was 3 kg in the placebo and 0.5 kg in the vildagliptin group .
RESULTS	Occurrence of hypoglycemia was low in both groups .
RESULTS	Insulin , C-peptide , glucose and glucagon levels were comparable during mixed meal tests .
CONCLUSIONS	This small randomized study did not have sufficient power to detect effects of the addition of vildagliptin to the start of once daily long-acting insulin .
CONCLUSIONS	However in our opinion adding a DPP4-inhibitor , especially in this group remains a very interesting approach .
CONCLUSIONS	This study could be used as a guidance for larger studies that are required to investigate the effects of this intervention on insulin requirements , glycemic variability , hypoglycemia and weight gain .

###24231016
BACKGROUND	It has been reported that adequate calcium intake decreases body fat and appropriate intakes of magnesium suppress the development of the metabolic syndrome .
BACKGROUND	Furthermore , lactulose increases the absorption of calcium and magnesium .
BACKGROUND	An optimal combination of calcium , magnesium and lactulose may therefore reduce body fat mass .
METHODS	An open-label randomized controlled trial was conducted to investigate the body fat-reducing effects of a test food containing 300 mg calcium , 150 mg magnesium , and 4.0 g lactulose .
METHODS	Body composition parameters and blood hormone and urine mineral concentrations were measured at baseline and at 6 and 12 months thereafter .
METHODS	Whole-body fat mass was measured with dual-energy x-ray absorptiometry .
RESULTS	Seventy-six middle-aged Japanese women ( 47.54.7 years ) were randomized to the intake group ( n = 48 ) or the non-intake control group ( n = 28 ) .
RESULTS	At 12 months the difference in body fat mass change between the two groups ( intake group - control group ) was -0.8 kg ( 95 % CI : -1.5 - 0.0 kg , p = 0.046 ) , although there were no differences in anthropometric data between the two groups .
RESULTS	Body fat percentage at 12 months tended to be lower in the intake group , but the difference was not significant ( p = 0.09 ) .
CONCLUSIONS	These findings may suggest that calcium in combination with magnesium and lactulose can reduce body fat mass in middle-aged Japanese women .
CONCLUSIONS	However , the contribution of magnesium and lactulose are unclear in this study .
CONCLUSIONS	Further studies are needed to clarify these contributions .

###25137370
OBJECTIVE	The present study investigated the effects of severe-intensity interval training at a frequency of once a week on cardiorespiratory function at rest and during exercise .
METHODS	Fourteen young healthy males were randomly assigned to either an interval training group or control group .
METHODS	Cardiorespiratory function was investigated by incremental maximal exercise test and constant work rate submaximal exercise test before and after the intervention period in all subjects .
METHODS	Submaximal exercise test was conducted at two work rates ( 80 % ventilatory threshold ( VT ) level and 100 % VT level plus 50 % of the difference between VT and peak oxygen consumption ( VO2 ) ) for 8 min ; the same work rates and duration were used before and after training .
METHODS	Left ventricular adaptations were assessed by echocardiography under supine resting conditions before and after training .
METHODS	In the interval training group , seven subjects performed cycle ergometer training once per week for 3 months .
METHODS	The training consisted of three bouts of exercises to volitional fatigue at 80 % maximum work rate .
RESULTS	Increased VO2max ( +13 % , P = 0.015 ) , VT ( +21 % , P = 0.001 ) , and left ventricular posterior wall thickness ( +18 % , P = 0.002 ) and reduced minute ventilation ( -12 % , P = 0.032 ) and blood lactate concentration ( -16 % , P = 0.025 ) during high-intensity exercise were observed after the training program compared with baseline .
RESULTS	Although not significant , VO2 and cycling economy ( VO2 per work rate ) during high-intensity exercise decreased slightly after training .
CONCLUSIONS	The present results indicate that severe-intensity interval training , even when performed at a low frequency , markedly improves cardiorespiratory function as well as induces cardiac morphological adaptations involving left ventricular hypertrophy and cardiorespiratory metabolic response during submaximal exercise .
CONCLUSIONS	The present findings may provide new insights for low-frequency , severe-intensity interval training in the field of sports science .

###26047808
BACKGROUND	Communication , impulse control and motivation can all be affected by Bipolar Disorder ( BD ) making consistent parenting more difficult than for parents without mental health problems .
BACKGROUND	Children of parents with BD ( CPB ) are at significantly increased risk of a range of mental health issues including Attention Deficit Hyperactivity Disorder ( ADHD ) , anxiety , depression , substance use , and sleep disorders .
BACKGROUND	Furthermore , CPB are also at elevated risk for BD compared to the general population .
BACKGROUND	This paper describes the rationale and protocol for a pilot randomised controlled trial ( RCT ) designed to assess the feasibility and acceptability of a new online intervention providing interactive psychoeducational information and parenting support for parents with BD .
METHODS	This article describes a single-blind randomised controlled trial comparing an Integrated Bipolar Parenting Intervention ( IBPI ) in addition to treatment as usual ( TAU ) with TAU alone .
METHODS	Participants will be recruited from across the UK from mental health services and through self-referral .
METHODS	The primary outcome of the study is the feasibility and acceptability of IBPI as indicated by recruitment to target , use of the intervention site , and retention to follow-up .
METHODS	Parents with BD allocated to the IBPI condition will have access to the intervention for 16 weeks .
METHODS	Effect size estimates will be obtained with respect to child behaviour , parenting skills and measures of parental mental health using measures taken at baseline ( 0 ) , and at 16 , 24 , 36 , and 48 weeks post randomization .
CONCLUSIONS	This is the first randomised controlled trial of an integrated bipolar disorder parenting intervention .
CONCLUSIONS	The benefits and challenges of delivering this online intervention , and evaluation using online RCT methodology are discussed .
BACKGROUND	Current Controlled Trials ISRCTN75279027 Registered 12 August 2013 .

###24991037
OBJECTIVE	To ( 1 ) investigate effects of aerobic walking on motor function , cognition , and quality of life in Parkinson disease ( PD ) , and ( 2 ) compare safety , tolerability , and fitness benefits of different forms of exercise intervention : continuous/moderate intensity vs interval/alternating between low and vigorous intensity , and individual/neighborhood vs group/facility setting .
METHODS	Initial design was a 6-month , 2 2 randomized trial of different exercise regimens in independently ambulatory patients with PD .
METHODS	All arms were required to exercise 3 times per week , 45 minutes per session .
RESULTS	Randomization to group/facility setting was not feasible because of logistical factors .
RESULTS	Over the first 2 years , we randomized 43 participants to continuous or interval training .
RESULTS	Because preliminary analyses suggested higher musculoskeletal adverse events in the interval group and lack of difference between training methods in improving fitness , the next 17 participants were allocated only to continuous training .
RESULTS	Eighty-one percent of 60 participants completed the study with a mean attendance of 83.3 % ( 95 % confidence interval : 77.5 % -89.0 % ) , exercising at 46.8 % ( 44.0 % -49.7 % ) of their heart rate reserve .
RESULTS	There were no serious adverse events .
RESULTS	Across all completers , we observed improvements in maximum oxygen consumption , gait speed , Unified Parkinson 's Disease Rating Scale sections I and III scores ( particularly axial functions and rigidity ) , fatigue , depression , quality of life ( e.g. , psychological outlook ) , and flanker task scores ( p < 0.05 to p < 0.001 ) .
RESULTS	Increase in maximum oxygen consumption correlated with improvements on the flanker task and quality of life ( p < 0.05 ) .
CONCLUSIONS	Our preliminary study suggests that aerobic walking in a community setting is safe , well tolerated , and improves aerobic fitness , motor function , fatigue , mood , executive control , and quality of life in mild to moderate PD .
METHODS	This study provides Class IV evidence that in patients with PD , an aerobic exercise program improves aerobic fitness , motor function , fatigue , mood , and cognition .

###24588932
BACKGROUND	Irritable bowel syndrome ( IBS ) is characterized by heterogeneous pathophysiology and low response to treatment .
BACKGROUND	Up to 60 % of IBS patients suffers from visceral hypersensitivity , which is associated with symptom severity and underlying pathophysiological mechanisms .
BACKGROUND	Recently , positive effects of probiotics in IBS have been reported , but overall the response was modest .
BACKGROUND	We performed a study in IBS patients , characterized by visceral hypersensitivity measured with the rectal barostat , aiming to assess the effect of 6weeks of multispecies probiotic mix on visceral pain perception .
METHODS	We conducted a randomized , placebo-controlled , double-blind trial in forty Rome III IBS patients with visceral hypersensitivity .
METHODS	Prior to intake , patients kept a 2-week symptom diary and underwent a rectal barostat measurement .
METHODS	When hypersensitivity was confirmed , participation was allowed and patients received a multispecies probiotic with in vitro proven potential beneficial effects on mechanisms contributing to visceral hypersensitivity ( six different probiotic strains ; 10 ( 9 ) cfu/g ) , or a placebo product of one sachet ( 5g ) per day for 6weeks .
METHODS	At the end of the intervention period , visceroperception and symptoms were reassessed .
RESULTS	Thirty-five patients completed the trial .
RESULTS	The percentage of patients with visceral hypersensitivity decreased significantly in the probiotic and placebo group ( 76.5 % and 71.4 % , respectively ; N.S. between groups ) .
RESULTS	Improvement in pain scores and mean symptom score did not differ between the probiotic and placebo group .
CONCLUSIONS	In this placebo-controlled trial in IBS patients with visceral hypersensitivity , no significant effect of a multispecies probiotic on viscerperception was observed .
CONCLUSIONS	The study has been registered in the US National Library of Medicine ( http://www.clinicaltrials.gov , NCT00702026 ) .

###24816997
BACKGROUND	The aim of this study was to determine the efficacy of real-time continuous glucose monitoring in T1D patients treated with insulin pump therapy or multiple daily insulin therapy .
METHODS	Twenty adult patients ( ten insulin pump therapy and ten multiple daily insulin ) with poor glycaemic control ( HbA1c > 8.0 % ) were randomized into two groups for 6 months : the continuous glucose monitoring arm ( using real-time continuous glucose monitoring ) and the SMBG arm .
METHODS	After 2 months of wash-out , the participants crossed over .
METHODS	The primary outcome was HbA1c reduction .
METHODS	The secondary outcomes were hypoglycaemia and hyperglycaemia risk assessment ( area under the curve < 70 mg/dL/day and AUC > 200 mg/dL/day , respectively ) and glucose variability .
RESULTS	Fourteen patients ( eight multiple daily insulin , six insulin pump therapy ) used continuous glucose monitoring appropriately ( at least 40 % of the time ) .
RESULTS	In these patients , the improvement in glycaemic control was more evident during the real-time continuous glucose monitoring period ( 7.76 % 0.4 vs 8.54 % 0.4 , p < 0.05 ) than during the self-monitoring of blood glucose period ( 8.42 % 0.4 vs 8.56 % 0.5 , p = 0.2 ) .
RESULTS	Better results with continuous glucose monitoring were observed in patients using multiple daily insulin with greater improvement in both glycaemic control ( 7.71 % 0.2 vs 8.58 % 0.2 , p < 0.05 ) and glucose variability and with a marked reduction in the risk of both hypoglycaemia and hyperglycaemia .
CONCLUSIONS	Appropriate use of real-time continuous glucose monitoring improved glycometabolic control in T1D patients .
CONCLUSIONS	The effects of continuous glucose monitoring were more evident in patients under multiple daily insulin treatment , compared with insulin pump therapy .
CONCLUSIONS	Glucose variability , in addition to glycaemic control , was improved in compliant diabetic patients .

###24281134
BACKGROUND	Acute heart failure is a common reason for admission , and outcome is often poor .
BACKGROUND	Improved prognostic risk stratification may assist in the design of future trials and in patient management .
BACKGROUND	Using data from a large randomized trial , we explored the prognostic value of clinical variables , measured at hospital admission for acute heart failure , to determine whether a few selected variables were inferior to an extended data set .
RESULTS	The prognostic model included 37 clinical characteristics collected at baseline in PROTECT , a study comparing rolofylline and placebo in 2033 patients admitted with acute heart failure .
RESULTS	Prespecified outcomes at 30 days were death or rehospitalization for any reason ; death or rehospitalization for cardiovascular or renal reasons ; and , at both 30 and 180 days , all-cause mortality .
RESULTS	No variable had a c-index > 0.70 , and few had values > 0.60 ; c-indices were lower for composite outcomes than for mortality .
RESULTS	Blood urea was generally the strongest single predictor .
RESULTS	Eighteen variables contributed independent prognostic information , but a reduced model using only 8 items ( age , previous heart failure hospitalization , peripheral edema , systolic blood pressure , serum sodium , urea , creatinine , and albumin ) performed similarly .
RESULTS	For prediction of all-cause mortality at 180 days , the model c-index using all variables was 0.72 and for the simplified model , also 0.72 .
CONCLUSIONS	A few simple clinical variables measured on admission in patients with acute heart failure predict a variety of adverse outcomes with accuracy similar to more complex models .
CONCLUSIONS	However , predictive models were of only moderate accuracy , especially for outcomes that included nonfatal events .
CONCLUSIONS	Better methods of risk stratification are required .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifiers : NCT00328692 and NCT00354458 .

###24965303
BACKGROUND	Exogenous glucagon-like peptide-1 ( GLP-1 ) inhibits eating in healthy , overweight , and diabetic subjects .
OBJECTIVE	The GLP-1 receptor antagonist exendin ( 9-39 ) NH2 ( ex9-39 ) was used to further explore the role of GLP-1 as an endogenous satiation signal .
METHODS	Two double-blind , 4-way crossover studies were performed , each of which included 10 healthy men .
METHODS	In study A , subjects received an intravenous infusion of ex9-39 or saline plus an oral glucose preload and an intraduodenal infusion of saline or glucose for 60 min .
METHODS	In study B , intravenous infusions were identical , but an oral mixed-liquid meal preload and a 60-min intraduodenal infusion of saline or oleic acid were administered .
METHODS	Thirty minutes after oral preloads , subjects ate and drank ad libitum , and amounts ingested and the time to meal completion were quantified .
METHODS	In addition , appetite and plasma GLP-1 , peptide YY ( PYY ) , insulin , glucagon , and blood glucose concentrations were measured .
RESULTS	In both studies , GLP-1 , PYY , and glucagon were substantially higher with intravenous ex9-39 than with intravenous saline ( P 0.001 ) .
RESULTS	Insulin was lower with intravenous ex9-39 during intraduodenal glucose ( P 0.05 ) .
RESULTS	The decrease in prospective food consumption and desire to eat during ad libitum eating after glucose ingestion was slightly attenuated ( P 0.05 and P 0.01 , respectively ) with ex9-39 .
RESULTS	However , with intravenous ex9-39 , food and fluid intakes and eating duration were not changed in either study .
CONCLUSIONS	GLP-1 receptor antagonism slightly modulates appetite during ad libitum eating , but food and fluid intakes and meal duration remain unchanged , suggesting that endogenous GLP-1 is a weak satiation signal .
CONCLUSIONS	However , concomitant substantial increases in plasma PYY and glucagon may counteract a desatiating effect of ex9-39 .
CONCLUSIONS	The effect of ex9-39 on PYY secretion supports an autoinhibitory feedback mechanism that controls L cell secretion ; the effect on insulin and glucagon confirms the role of GLP-1 in glycemic control through its action on pancreatic and cells .

###25363118
BACKGROUND	Drug dependence is a major problem in our country and in international level .
BACKGROUND	Reality therapy is an internal control system that determines why and how to choose the options that are set for our lives .
BACKGROUND	This study aimed to investigate the effect of reality therapy on metacognition , stress and decline in hope in drug addicts .
METHODS	This study is quasi-experimental study .
METHODS	Samples were chosen convenient among 60 drug addicts in Jahrom in 2012 .
METHODS	Samples were randomly divided into two groups ( each group = 30 ) of intervention and control groups .
METHODS	Control group received usual care and experimental group received reality therapy .
RESULTS	Results revealed that there was significant difference between the mean scores of metacognition and hope before and after the intervention of experimental group ( p < 0.05 ) .
RESULTS	Also , there was statistically significant difference between the two groups from these two variables ( p < 0.05 ) .
RESULTS	but , Stress level was n't statistically different in two groups .
CONCLUSIONS	Reality therapy is a method that emphasizes the accountability and the current behavior of individuals .
CONCLUSIONS	Setting negative emotions , reality therapy promotes metacognition and , through increasing accountability to self-behavior improves hope .

###25713953
OBJECTIVE	We sought to test the efficacy of a sexual risk intervention for male clients of female sex workers ( FSWs ) and examine whether efficacy was moderated by syndemic risk .
METHODS	From 2010 to 2014 , we conducted a 2-arm randomized controlled trial ( 60-minute , theory-based , safer sex intervention versus a didactic time-equivalent attention control ) that included 400 male clients of FSWs on the US-Mexico border with follow-up at 4 , 8 , and 12 months .
METHODS	We measured 5 syndemic risk factors , including substance use and depression .
METHODS	Primary outcomes were sexually transmitted infections incidence and total unprotected sex with FSWs .
RESULTS	Although participants in both groups became safer , there was no significant difference in behavior change between groups .
RESULTS	However , baseline syndemic risk moderated intervention efficacy .
RESULTS	At baseline , there was a positive association between syndemic risk and unprotected sex .
RESULTS	Then at 12 months , longitudinal analyses showed the association depended on intervention participation ( B = -0.71 ; 95 % confidence interval [ CI ] = -1.22 , -0.20 ; P = .007 ) .
RESULTS	Among control participants there still existed this modest association ( B = 0.36 ; 95 % CI = -0.49 , 1.22 ; P = .09 ) ; among intervention participants there was a significant negative association ( B = -0.35 ; 95 % CI = -0.63 , -0.06 ; P = .02 ) .
CONCLUSIONS	A brief intervention might attenuate syndemic risks among clients of FSWs .
CONCLUSIONS	Other populations experiencing syndemic problems may also benefit from such programs .

###24780615
BACKGROUND	Despite preoperative anaemia treatment , a risk of postoperative anaemia remains .
BACKGROUND	This randomized , controlled study evaluated the efficacy of i.v. ferric carboxymaltose ( FCM ) as postoperative anaemia treatment after total knee arthroplasty ( TKA ) .
METHODS	TKA patients with postoperative anaemia [ haemoglobin ( Hb ) 8.5-12 .0 g dl ( -1 ) ] without prior transfusions were randomly assigned to FCM [ 700-1000 mg iron ( according to calculate iron deficit on postoperative day 2 ) ] or ferrous glycine sulphate ( FS ; 100 mg iron daily from day 7 onwards ) and followed for Hb , iron status , quality-of-life ( EQ-5D ) , and performance ( 6 min walk test ) until day 30 .
RESULTS	Of 161 preoperatively non-anaemic patients , 122 ( 75.8 % ) developed anaemia after operation ( within 24 h ) and were enrolled in this study ( 60 FCM , 62 FS ) .
RESULTS	Hb substantially decreased until day 4 in both groups , and partly recovered by day 30 .
RESULTS	FCM-treated patients achieved Hb 12.0 g dl ( -1 ) more frequently ( 42.3 % vs 23.5 % ; P = 0.04 ) and showed a trend towards higher Hb increase from day 4 to day 30 [ +1.7 ( 1.2 ) vs +1.3 ( 1.0 ) ; P = 0.075 ] compared with FS-treated patients .
RESULTS	Patients with postoperative Hb < 10 g dl ( -1 ) experienced better Hb increase with FCM [ +2.4 ( 0.3 ) g dl ( -1 ) ] than FS [ +1.1 ( 0.4 ) g dl ( -1 ) ; P = 0.018 ] .
RESULTS	Patients being iron-deficient at enrolment ( 56.7 % ) had a higher Hb increase with FCM [ +1.9 ( 0.3 ) g dl ( -1 ) ] than FS [ +1.2 ( 0.2 ) g dl ( -1 ) ; P = 0.03 ] .
RESULTS	Total EQ-5D and performance outcomes were comparable between the groups , but FCM was associated with better scores for ` usual activities ' .
RESULTS	No i.v. iron-related adverse events were reported .
CONCLUSIONS	Preoperatively non-anaemic TKA patients are at high risk of postoperative anaemia .
CONCLUSIONS	Postoperative i.v. FCM provided significant benefit over oral FS , particularly in patients with preoperative iron deficiency , severe postoperative anaemia , or both .
BACKGROUND	EudraCT 2010-023038-22 ; ClinicalTrials.gov NCT01913808 .

###25026953
OBJECTIVE	To compare the efficacy of gradient and swim-up semen preparation techniques on pregnancy rates in couples undergoing intrauterine insemination ( IUI ) cycles with low dose gonadotropin stimulation with the diagnosis of unexplained or mild male subfertility .
METHODS	Two hundred and twenty three couples were randomized into swim up or gradient technique groups for sperm preperation .
METHODS	The clinical and on going pregnancy rates per cycle and per patient were evaluated .
RESULTS	Both clinical and ongoing pregnancy rates per cycle were significantly higher in the `` gradient '' group ( 19 % and 16.9 % ) in comparision with the `` swim up '' group ( 9.7 % and 6.9 % ) ( p < 0.05 ) .
RESULTS	Clinical pregnancy and on-going pregnancy rates per patient were higher in the `` gradient '' group ( 26.1 % and 23.4 % ) when compared to the `` swim up '' group ( 15.2 % and 10.7 % ) , ( p < 0.05 ) .
RESULTS	In the subgroup of 191 unexplained subfertile couples with 290 cycles ; the `` gradient '' group also revealed significantly higher clinical and ongoing pregnancy rates per cycle ( 21.6 % and 17.9 % ) when compared with the `` swim up '' group ( 10.3 % and 7.1 % ) ( p < 0.05 ) .
RESULTS	In total of 48 treatment cycles upon 32 couples with mild male factor subfertility no significant difference were found between the two sperm preparation techniques in terms of clinical ( % 5.3 vs % 6.9 , p > 0.05 ) and ongoing ( % 5.3 vs % 6.9 , p > 0.05 ) pregnancy rates per cycle .
CONCLUSIONS	The gradient technique significantly improves clinical outcome in IUI cycles of unexplained subfertile couples when compared to swim up technique .
CONCLUSIONS	In male subfertile patients , both techniques yield similar clinical outcomes .

###25168346
BACKGROUND	The factors influencing the decision making of operative treatment for fractures of the proximal humerus are debated .
BACKGROUND	We hypothesized that there is no difference in treatment recommendations between surgeons shown radiographs alone and those shown radiographs and patient information .
BACKGROUND	Secondarily , we addressed ( 1 ) factors associated with a recommendation for operative treatment , ( 2 ) factors associated with recommendation for arthroplasty , ( 3 ) concordance with the recommendations of the treating surgeons , and ( 4 ) factors affecting the inter-rater reliability of treatment recommendations .
METHODS	A total of 238 surgeons of the Science of Variation Group rated 40 radiographs of patients with proximal humerus fractures .
METHODS	Participants were randomized to receive information about the patient and mechanism of injury .
METHODS	The response variables included the choice of treatment ( operative vs nonoperative ) and the percentage of matches with the actual treatment .
RESULTS	Participants who received patient information recommended operative treatment less than those who received no information .
RESULTS	The patient information that had the greatest influence on treatment recommendations included age ( 55 % ) and fracture mechanism ( 32 % ) .
RESULTS	The only other factor associated with a recommendation for operative treatment was region of practice .
RESULTS	There was no significant difference between participants who were and were not provided with information regarding agreement with the actual treatment ( operative vs nonoperative ) provided by the treating surgeon .
CONCLUSIONS	Patient information-older age in particular-is associated with a higher likelihood of recommending nonoperative treatment than radiographs alone .
CONCLUSIONS	Clinical information did not improve agreement of the Science of Variation Group with the actual treatment or the generally poor interobserver agreement on treatment recommendations .

###26181707
BACKGROUND	Cobicistat ( COBI ) is a pharmacoenhancer with no antiretroviral activity .
METHODS	International , randomized double-blind active-controlled trial to evaluate the efficacy and safety of COBI vs ritonavir ( RTV ) as a pharmacoenhancer of atazanavir in combination with emtricitabine/tenofovir disoproxil fumarate in HIV treatment-naive patients followed through week 144 .
RESULTS	At Week 144 , virologic suppression was achieved in 72 % ( COBI ) and 74 % ( RTV ) of patients .
RESULTS	Adverse events leading to study drug discontinuation occurred in 11 % of patients in each group .
RESULTS	Median changes in serum creatinine ( mg/dL ) were +0.13 ( COBI ) and +0.07 ( RTV ) and were unchanged from week 48 .
CONCLUSIONS	Once-daily COBI is a safe and effective pharmacoenhancer of the protease inhibitor atazanavir .

###25194079
OBJECTIVE	To evaluate the efficacy of intermittent percutaneous needle sacral nerve stimulation ( IPN-SNS ) in women with idiopathic overactive bladder ( IOAB ) treated with tolterodine .
METHODS	A total of 240 female patients diagnosed with IOAB were randomized to receive tolterodine only treatment ( group 1 , n = 120 ) or tolterodine combined with IPN-SNS ( group 2 , n = 120 ) .
METHODS	Each group included 120 participants , who were divided into subgroups depending on whether they had dry OAB ( urinary frequency and urgency ) or wet OAB ( urinary frequency and urgency with urgency incontinence ) .
METHODS	In the treatment group , patients received percutaneous IPN-SNS plus tolterodine ( 2 mg once daily ) , while in the control group , only tolterodine ( 2 mg once daily ) was administered for 3 months .
METHODS	The voiding diary and urodynamic parameters were monitored , and patients ' psychological depression and anxiety scores were recorded before and after treatment .
RESULTS	There were significantly greater improvements in the conditions of first desire to void ( FDV ) , maximum cystometric capacity ( MCC ) , and daily average volumes , as well as the daily single maximum voided volumes in group 2 ( P = .001 ) than in group 1 .
RESULTS	In addition , there were significantly greater decreases in self-rating depression scale ( SDS ) and self-rating anxiety scale ( SAS ) scores in group 2 compared with group 1 ( P < .001 ) .
CONCLUSIONS	Combined treatment with tolterodine plus IPN-SNS can not only improve the symptoms of voiding dysfunction but can also reduce the concomitant depression and anxiety in women with IOAB , thereby improving patients ' quality of life .

###25158046
OBJECTIVE	To determine if high-intensity , task-oriented , visual feedback training with a video game balance board ( Nintendo Wii ) induces significant changes in diffusion-tensor imaging ( DTI diffusion-tensor imaging ) parameters of cerebellar connections and other supratentorial associative bundles and if these changes are related to clinical improvement in patients with multiple sclerosis .
METHODS	The protocol was approved by local ethical committee ; each participant provided written informed consent .
METHODS	In this 24-week , randomized , two-period crossover pilot study , 27 patients underwent static posturography and brain magnetic resonance ( MR ) imaging at study entry , after the first 12-week period , and at study termination .
METHODS	Thirteen patients started a 12-week training program followed by a 12-week period without any intervention , while 14 patients received the intervention in reverse order .
METHODS	Fifteen healthy subjects also underwent MR imaging once and underwent static posturography .
METHODS	Virtual dissection of white matter tracts was performed with streamline tractography ; values of DTI diffusion-tensor imaging parameters were then obtained for each dissected tract .
METHODS	Repeated measures analyses of variance were performed to evaluate whether DTI diffusion-tensor imaging parameters significantly changed after intervention , with false discovery rate correction for multiple hypothesis testing .
RESULTS	There were relevant differences between patients and healthy control subjects in postural sway and DTI diffusion-tensor imaging parameters ( P < .05 ) .
RESULTS	Significant main effects of time by group interaction for fractional anisotropy and radial diffusivity of the left and right superior cerebellar peduncles were found ( F2 ,23 range , 5.555-3 .450 ; P = .036 -.088 after false discovery rate correction ) .
RESULTS	These changes correlated with objective measures of balance improvement detected at static posturography ( r = -0.381 to 0.401 , P < .05 ) .
RESULTS	However , both clinical and DTI diffusion-tensor imaging changes did not persist beyond 12 weeks after training .
CONCLUSIONS	Despite the low statistical power ( 35 % ) due to the small sample size , the results showed that training with the balance board system modified the microstructure of superior cerebellar peduncles .
CONCLUSIONS	The clinical improvement observed after training might be mediated by enhanced myelination-related processes , suggesting that high-intensity , task-oriented exercises could induce favorable microstructural changes in the brains of patients with multiple sclerosis .

###25720711
OBJECTIVE	To explore the effectiveness of the color Doppler ultrasound-guided botulinum toxin type A ( BTX-A ) injection combined with an ankle foot brace ( AFO ) for treating lower limb spasticity after a stroke .
METHODS	A total of 103 post-stroke patients with lower limb spasticity were divided into three groups : the control group treated with conventional therapy and rehabilitation training , the observation group treated with conventional therapy , rehabilitation training and botulinum toxin type A injection , the treatment group treated with AFO plus the same treatment received by the observation group .
METHODS	The muscle spasms were evaluated using the Clinic Spasticity Influx ( CSI ) , movement with the Fugl-Meyer Assessment ( FMA ) , dynamic and static balance with the Berg Balance Scale ( BBS ) , and daily life activities with the Functional Independence Measure ( FIM ) , respectively .
RESULTS	Compared the first month after treatment with the prior treatment , there were significant differences in CSI , FMA and FIM scores in both control group and the observation group ( p < 0.05 ) .
RESULTS	However , no differences were noticed in the control group ( p > 0.05 ) .
RESULTS	Compared the third and sixth month after treatment with prior treatment , there were significant differences in these three groups ( p < 0.05 ) .
RESULTS	In terms of treatment time , the BBS scores were always higher in all three groups after one month , three months and six months treatment than prior treatment ( p < 0.05 ) , and there were significant differences in third month and sixth month after treatment compared with the first month treatment ( p < 0.05 ) .
RESULTS	Compared the third month after treatment with the sixth month , there were significant differences in all three groups ( p < 0.05 ) .
CONCLUSIONS	The color Doppler ultrasound-guided BTX-A injection combined with AFO can effectively promote patients with post-stroke lower limb spasticity in lower limb muscle spasm , movement , balance and daily life activities .

###25500887
BACKGROUND	Previous efforts to preserve cell function in individuals with type 1 diabetes ( T1D ) have focused largely on the use of single immunomodulatory agents administered within 100 days of diagnosis .
BACKGROUND	Based on human and preclinical studies , we hypothesized that a combination of low-dose anti-thymocyte globulin ( ATG ) and pegylated granulocyte CSF ( G-CSF ) would preserve cell function in patients with established T1D ( duration of T1D > 4 months and < 2 years ) .
METHODS	A randomized , single-blinded , placebo-controlled trial was performed on 25 subjects : 17 subjects received ATG ( 2.5 mg/kg intravenously ) followed by pegylated G-CSF ( 6 mg subcutaneously every 2 weeks for 6 doses ) and 8 subjects received placebo .
METHODS	The primary outcome was the 1-year change in AUC C-peptide following a 2-hour mixed-meal tolerance test ( MMTT ) .
METHODS	At baseline , the age ( mean SD ) was 24.6 10 years ; mean BMI was 25.4 5.2 kg/m ; mean A1c was 6.5 % 1.1 % ; insulin use was 0.31 0.22 units/kg/d ; and length of diagnosis was 1 0.5 years .
RESULTS	Combination ATG/G-CSF treatment tended to preserve cell function in patients with established T1D .
RESULTS	The mean difference in MMTT-stimulated AUC C-peptide between treated and placebo subjects was 0.28 nmol/l/min ( 95 % CI 0.001-0 .552 , P = 0.050 ) .
RESULTS	A1c was lower in ATG/G-CSF-treated subjects at the 6-month study visit .
RESULTS	ATG/G-CSF therapy was associated with relative preservation of Tregs .
CONCLUSIONS	Patients with established T1D may benefit from combination immunotherapy approaches to preserve cell function .
CONCLUSIONS	Further studies are needed to determine whether such approaches may prevent or delay the onset of the disease .
BACKGROUND	Clinicaltrials.gov NCT01106157 .
BACKGROUND	The Leona M. and Harry B. Helmsley Charitable Trust and Sanofi .

###24532830
OBJECTIVE	To test the hypothesis that colchicine use during early disease decreases immunosuppressive use in Behet syndrome ( BS ) in the long term .
METHODS	Patients with BS who participated in a double-blind , placebo-controlled trial of colchicine 16.61.1 years ago were evaluated for immunosuppressive use during the posttrial period .
RESULTS	We could contact 90/116 patients ; 28 ( 31 % ) received immunosuppressives during the posttrial period , 14 being from the colchicine arm .
RESULTS	Posttrial colchicine use and cumulative duration were similar between patients who received immunosuppressives and those who did not .
CONCLUSIONS	Continuous use of colchicine , even when initiated at an early disease stage , does not seem to decrease the use of immunosuppressives in the long term .

###25323005
BACKGROUND	Feeding polyphenol-rich plant products has been shown to increase the gain : feed ratio in growing pigs .
BACKGROUND	The reason for this finding has not yet been elucidated .
BACKGROUND	In order to find the reasons for an increase of the gain : feed ratio , this study investigated the effect of two polyphenol-rich dietary supplements , grape seed and grape marc meal extract ( GSGME ) or spent hops ( SH ) , on gut morphology , apparent digestibility of nutrients , microbial composition in faeces and the expression of pro-inflammatory genes in the intestine of pigs .
RESULTS	Pigs fed GSGME or SH showed an improved gain : feed ratio in comparison to the control group ( P < 0.10 for GSGME , P < 0.05 for SH ) .
RESULTS	Villus height : crypt depth ratio in duodenum and jejunum as well as apparent total tract digestibility of nutrients were unchanged in the groups receiving GSGME or SH in comparison to the control group .
RESULTS	However , the groups receiving GSGME or SH revealed an increased faecal pH value , lower levels of volatile fatty acids and lower counts of Streptococcus spp .
RESULTS	and Clostridium Cluster XIVa in the faecal microbiota ( P < 0.05 ) .
RESULTS	Moreover , both treatment groups had a lower expression of various pro-inflammatory genes in duodenum , ileum and colon than the control group ( P < 0.05 ) .
CONCLUSIONS	The present study suggests that dietary plant products rich in polyphenols are able to improve the gain : feed ratio in growing pigs .
CONCLUSIONS	It is assumed that an alteration in the microbial composition and anti-inflammatory effects of the polyphenol-rich plant products in the intestine might contribute to this effect .

###24595801
BACKGROUND	Accuracy of the radiologic diagnosis of gastric cancer staging after neoadjuvant chemotherapy remains unclear .
METHODS	Patients enrolled in the COMPASS trial , a randomized phase II study comparing two and four courses of S-1 plus cisplatin and paclitaxel and cisplatin followed by gastrectomy , were examined .
METHODS	The radiologic stage was determined by using thin-slice computed tomography ( CT ) or multidetector low CT by following Habermann 's method .
RESULTS	A total of 75 patients registered in the COMPASS study who underwent surgical resection were examined in this study .
RESULTS	The radiologic T and pathologic T stages were not significantly correlated ( p = 0.221 ) .
RESULTS	The radiologic accuracy and rates of underdiagnosis and overdiagnosis were 42.7 , 10.7 , and 46.7 % , respectively .
RESULTS	When patients were stratified according to the pathologic response of the primary tumor , the correlation was not significant in either the responders ( n = 32 , p = 0.410 ) or the nonresponders ( n = 43 , p = 0.742 ) .
RESULTS	The radiologic accuracy was 37.5 % in the responders and 42.7 % in the nonresponders .
RESULTS	The radiologic N and pathologic N stages were significantly correlated ( p = 0.000 ) .
RESULTS	The radiologic accuracy and rates of underdiagnosis and overdiagnosis were 44 , 29.3 , and 26.7 % , respectively .
RESULTS	When stratifying the patients with measurable lymph nodes according only to the radiologic response , the correlation was significant in the nonresponders ( n = 23 , p = 0.035 ) but not in the responders ( n = 28 , p = 0.634 ) .
RESULTS	The radiologic accuracy was 39.3 % in the responders and 52.1 % in the nonresponders .
CONCLUSIONS	Restaging using CT after neoadjuvant chemotherapy for gastric cancer is considered to be inaccurate and unreliable .
CONCLUSIONS	In particular , the radiologic T-staging determined after neoadjuvant chemotherapy should not be considered in clinical decision-making .

###25046667
BACKGROUND	Most randomized trials have shown similar results with endoscopic carpal tunnel release ( ECTR ) and open carpal tunnel release ( OCTR ) ; however , there are studies suggesting less postoperative pain , faster improvement in grip and pinch strength , and earlier return to work with the endoscopic technique .
BACKGROUND	The goal of this study was to prospectively examine subjective and functional outcomes , satisfaction , and complications after both ECTR and OCTR in the opposite hands of the same patient , serving as their own control .
METHODS	This was a prospective , randomized study in which patients underwent surgery for bilateral carpal tunnel syndrome .
METHODS	The first carpal tunnel release was performed on the most symptomatic hand-determined by the patient .
METHODS	Operative approach was randomly assigned and , approximately 1 month later , the alternative technique was performed on the contralateral side .
METHODS	Demographic data were obtained , and functional outcomes were recorded preoperatively and postoperatively , including pain score , 2-point discrimination , Semmes-Weinstein monofilament testing , thenar strength , and overall grip strength .
METHODS	The carpal tunnel syndrome-functional status score and carpal tunnel syndrome-symptom severity score were recorded before surgery and at 2 , 4 , 8 , 12 , and 24 weeks postoperatively .
METHODS	Overall satisfaction with each technique was recorded at the conclusion of the study .
RESULTS	Currently , 25 subjects have completed final visit testing .
RESULTS	There were no differences in pain score , 2-point discrimination , Semmes-Weinstein monofilament testing , thenar strength , or overall grip strength at any of the postoperative time points .
RESULTS	Carpal tunnel syndrome-symptom severity score and carpal tunnel syndrome-functional status score were not significantly different between groups at any of the evaluations .
RESULTS	Overall satisfaction , where patients recorded a number from 0 to 100 , was significantly greater in the ECTR group ( 95.95 vs 91.60 , P = 0.04 ) .
RESULTS	There were no complications with either technique .
CONCLUSIONS	This interim analysis , using the same patient as an internal control , suggests that both OCTR and ECTR are well tolerated with no differences in functional outcomes , symptom severity and functional status questionnaires , or complications .
CONCLUSIONS	Although there were no differences between groups using our study metrics , patients still preferred the ECTR , demonstrated by significantly higher overall satisfaction scores at the conclusion of the study .

###25015215
OBJECTIVE	To evaluate the 24-month efficacy and safety of intravitreal ranibizumab 0.5 mg and 2.0 mg administered monthly or as needed ( pro re nata [ PRN ] ) in patients with neovascular age-related macular degeneration ( wet AMD ) .
METHODS	Twenty-four-month , multicenter , randomized , double-masked , active treatment-controlled phase 3 trial .
METHODS	Patients ( n = 1098 ) 50 years of age with treatment-nave subfoveal wet AMD .
METHODS	Patients were randomized to receive intravitreal injections of ranibizumab 0.5 mg or 2.0 mg monthly or PRN after 3 monthly loading doses .
METHODS	The primary efficacy end point was the mean change in best-corrected visual acuity ( BCVA ) from baseline at month 12 .
METHODS	Key secondary end points included mean change in BCVA from baseline at month 24 , proportion of patients who gained 15 letters in BCVA , mean number of ranibizumab injections , and mean change in central foveal thickness from baseline over time by spectral-domain optical coherence tomography .
METHODS	Ocular and systemic safety events also were evaluated through month 24 .
RESULTS	At month 24 , the mean change from baseline in BCVA was ( letters ) +9.1 ( 0.5 mg monthly ) , +7.9 ( 0.5 mg PRN ) , +8.0 ( 2.0 mg monthly ) , and +7.6 ( 2.0 mg PRN ) .
RESULTS	The change in mean BCVA from month 12 to 24 was ( letters ) -1.0 , -0.3 , -1.2 , and -1.0 , respectively .
RESULTS	The proportion of patients who gained 15 letters from baseline in BCVA at month 24 was 34.5 % , 33.1 % , 37.6 % , and 34.8 % , respectively .
RESULTS	The mean number of ranibizumab injections through month 24 was 21.4 , 13.3 , 21.6 , and 11.2 , respectively ; 5.6 and 4.3 mean injections were required in year 2 in the 0.5 mg and 2.0 mg PRN groups , respectively .
RESULTS	The average treatment interval in the 0.5 mg PRN group was 9.9 weeks after 3 monthly loading doses , and 93 % of these patients did not require monthly dosing .
RESULTS	Ocular and systemic safety profiles over 2 years were similar among all 4 treatment groups and were consistent with previous ranibizumab trials in AMD .
CONCLUSIONS	At month 24 , mean BCVA improvements were clinically meaningful and similar among all 4 ranibizumab treatment groups .
CONCLUSIONS	The 0.5 mg PRN group achieved a mean gain of 7.9 letters at month 24 with an average of 13.3 injections ( 5.6 injections in year 2 ) .
CONCLUSIONS	No new safety events were identified over 24 months .

###25480461
BACKGROUND	Lifestyle modification is recommended for management of prehypertension , yet finding effective interventions to reach rural women is a public health challenge .
BACKGROUND	This community-based clinical trial compared the effectiveness of standard advice to two multi-component theory-based tailored interventions , using web-based or print-mailed delivery , in reducing blood pressure among rural women , ages 40-69 , with prehypertension .
METHODS	289 women with prehypertension enrolled in the Wellness for Women : DASHing towards Health trial , a 12-month intervention with 12-month follow-up .
METHODS	Women were randomly assigned to groups using a 1:2:2 ratio , comparing standard advice ( 30-minute counseling session ) to two interventions ( two 2-hour counseling sessions , 5 phone goal-setting sessions , strength-training video , and 16 tailored newsletters , web-based or print-mailed ) .
METHODS	Linear mixed model methods were used to test planned pairwise comparisons of marginal mean change in blood pressure , healthy eating and activity , adjusted for age and baseline level .
METHODS	General estimating equations were used to examine the proportion of women achieving normotensive status and meeting health outcome criteria for eating and activity .
RESULTS	Mean blood pressure reduction ranged from 3.8 ( SD = 9.8 ) mm Hg to 8.1 ( SD = 10.4 ) mm Hg .
RESULTS	The 24-month estimated marginal proportions of women achieving normotensive status were 47 % for web-based , and 39 % for both print-mailed and standard advice groups , with no group differences ( p = .11 and p = .09 , respectively ) .
RESULTS	Web-based and print-mailed groups improved more than standard advice group for waist circumference ( p = .017 and p = .016 , respectively ) ; % daily calories from fat ( p = .018 and p = .030 ) and saturated fat ( p = .049 and p = .013 ) ; daily servings of fruit and vegetables ( p = .008 and p < .005 ) ; and low fat dairy ( p < .001 and p = .002 ) .
RESULTS	Greater improvements were observed in web-based versus standard advice groups in systolic blood pressure ( p = .048 ) and estimated VO2max ( p = .037 ) .
RESULTS	Dropout rates were 6 % by 6-months , 11.4 % by 24 months , with no differences across groups .
CONCLUSIONS	Rural women with prehypertension receiving distance-delivery theory-based lifestyle modifications can achieve a reduction of blood pressure and attainment of normotensive status .
BACKGROUND	ClinicalTrials.gov NCT00580528 .

###24796463
OBJECTIVE	To investigate the safety and efficacy of trastuzumab administered concurrently with anthracycline-containing adjuvant regimen for breast cancer .
METHODS	It is a prospective , randomized and controlled trial .
METHODS	Participants were randomized to receive trastuzumab administered concurrently or sequentially with anthracycline-containing adjuvant regimen .
METHODS	The primary endpoint was cardiac safety .
METHODS	The second endpoints were disease-free survival ( DFS ) and overall survival ( OS ) .
RESULTS	One hundred and nine breast cancer patients were enrolled and randomized in this trial .
RESULTS	Fifty-five participants received trastuzumab administered concurrently with anthracycline-containing adjuvant regimen and 54 patients received trastuzumab administered sequentially with anthracycline .
RESULTS	The primary cardiac event was asymptomatic decrease in the left ventricular ejection fraction ( LVEF ) .
RESULTS	There was no significant difference between concurrent and sequential groups in cardiac event rates ( 9.1 % vs13 .0 % , P = 0.556 ) , neither of LVEF values at basline or at 3 , 6 , 9 and 12 months during trastuzumab treatment ( P > 0.05 ) .
RESULTS	Four patients ( 7.3 % ) in the concurrent group suffered local recurrences or distant metastases , and 6 participants ( 11.1 % ) in the sequential group had distant metastases .
RESULTS	There was no significant difference between the two groups in DFS ( P = 0.724 ) .
RESULTS	There was no death in both groups .
CONCLUSIONS	Trastuzumab administered concurrently with anthracycline is a safe adjuvant regimen for breast cancer and does not increase cardiac events .
CONCLUSIONS	Further research is needed to determine the efficacy of this treatment regimen .

###24551257
BACKGROUND	Anthroponotic cutaneous leishmaniasis ( CL ) due to Leishmania ( L. ) tropica infection is a chronic , frequently disfiguring skin disease with limited therapeutic options .
BACKGROUND	In endemic countries healing of ulcerative lesions is often delayed by bacterial and/or fungal infections .
BACKGROUND	Here , we studied a novel therapeutic concept to prevent superinfections , accelerate wound closure , and improve the cosmetic outcome of ACL .
RESULTS	From 2004 to 2008 we performed a two-armed , randomized , double-blinded , phase IIa trial in Kabul , Afghanistan , with patients suffering from L. tropica CL .
RESULTS	The skin lesions were treated with bipolar high-frequency electrocauterization ( EC ) followed by daily moist-wound-treatment ( MWT ) with polyacrylate hydrogel with ( group I ) or without ( group II ) pharmaceutical sodium chlorite ( DAC N-055 ) .
RESULTS	Patients below age 5 , with facial lesions , pregnancy , or serious comorbidities were excluded .
RESULTS	The primary , photodocumented outcome was the time needed for complete lesion epithelialization .
RESULTS	Biopsies for parasitological and ( immuno ) histopathological analyses were taken prior to EC ( 1 ( st ) ) , after wound closure ( 2 ( nd ) ) and after 6 months ( 3 ( rd ) ) .
RESULTS	The mean duration for complete wound closure was short and indifferent in group I ( 59 patients , 43.1 d ) and II ( 54 patients , 42 d ; p = 0.83 ) .
RESULTS	In patients with Leishmania-positive 2 ( nd ) biopsies DAC N-055 caused a more rapid wound epithelialization ( 37.2 d vs. 58.3 d ; p = 0.08 ) .
RESULTS	Superinfections occurred in both groups at the same rate ( 8.8 % ) .
RESULTS	Except for one patient , reulcerations ( 10.2 % in group I , 18.5 % in group II ; p = 0.158 ) were confined to cases with persistent high parasite loads after healing .
RESULTS	In vitro , DAC N-055 showed a leishmanicidal effect on pro- and amastigotes .
CONCLUSIONS	Compared to previous results with intralesional antimony injections , the EC plus MWT protocol led to more rapid wound closure .
CONCLUSIONS	The tentatively lower rate of relapses and the acceleration of wound closure in a subgroup of patients with parasite persistence warrant future studies on the activity of DAC N-055 .
BACKGROUND	ClinicalTrails.gov NCT00947362 .

###24457527
OBJECTIVE	To evaluate the effects of energy restriction with or without aerobic exercise on thigh muscle mass and quality in adults with visceral adiposity .
METHODS	75 males and females were randomly assigned to the groups ` diet only ' ( DO ; n = 42 ) or ` diet plus aerobic exercise ' ( D/Ex ; n = 33 ) for 12 weeks .
METHODS	The target energy intake in both groups was 25 kcal/kg of ideal body weight .
METHODS	Subjects in the D/Ex group were instructed to exercise for 300 min/week at lactate threshold .
METHODS	Computed tomography was used to measure thigh muscle cross-sectional area ( CSA ) , normal-density muscle area ( NDMA ) , and visceral fat area .
RESULTS	Total body weight ( DO : -6.6 3.6 % ; D/Ex : -7.3 4.6 % ) and visceral fat ( DO : -16.0 13.8 % ; D/Ex : -23.1 14.7 % ) decreased significantly in both groups ; however , the changes were not significantly different between the two groups .
RESULTS	The decrease in muscle CSA was significantly greater in the DO group ( -5.1 4.5 % ) compared with the D/Ex group ( -2.5 5.0 % ) .
RESULTS	NDMA decreased significantly in the DO ( -4.9 4.9 % ) but not in the D/Ex group ( -1.4 5.0 % ) .
CONCLUSIONS	Aerobic exercise attenuated the loss of skeletal muscle during energy restriction in adults with visceral adiposity .

###24621960
OBJECTIVE	Splanchnic hypoperfusion is a physiological phenomenon during strenuous exercise .
OBJECTIVE	It has been associated with gastrointestinal symptoms and intestinal injury and may hamper athletic performance .
OBJECTIVE	We hypothesized that L-citrulline supplementation improves splanchnic perfusion and decreases intestinal injury by enhancing arginine availability .
OBJECTIVE	The aim of this study was to determine the effect of L-citrulline intake on splanchnic perfusion , intestinal injury , and barrier function during exercise .
METHODS	In this randomized , double-blind crossover study , 10 men cycled for 60 min at 70 % of their maximum workload after L-citrulline ( 10 g ) or placebo ( L-alanine ) intake .
METHODS	Splanchnic perfusion was assessed using gastric air tonometry .
METHODS	Sublingual microcirculation was evaluated by sidestream dark field imaging .
METHODS	Plasma amino acid levels and intestinal fatty acid binding protein concentrations , reflecting enterocyte damage , were assessed every 10 min .
METHODS	Urinary excretion of sugar probes was measured to evaluate intestinal permeability changes .
RESULTS	Oral L-citrulline supplementation enhanced plasma citrulline ( 1840.3 142.3 M ) and arginine levels ( 238.5 9.1 M ) compared with that in placebo ( 45.7 4.8 M and 101.5 6.1 M , respectively , P < 0.0001 ) , resulting in increased arginine availability .
RESULTS	Splanchnic hypoperfusion was prevented during exercise after L-citrulline ingestion ( reflected by unaltered gapg-apCO2 levels ) , whereas gapg-apCO2 increased with placebo treatment ( P < 0.01 ) .
RESULTS	Accordingly , L-citrulline intake resulted in an increased number of perfused small sublingual vessels compared with that in placebo ( 7.8 6.0 vs -2.0 2.4 , P = 0.06 ) .
RESULTS	Furthermore , plasma intestinal fatty acid binding protein levels were attenuated during exercise after L-citrulline supplementation compared with that in placebo ( AUC0-60 min , -185 % 506 % vs 1318 % 553 % , P < 0.01 ) .
RESULTS	No significant differences were observed for intestinal permeability .
CONCLUSIONS	Pre-exercise L-citrulline intake preserves splanchnic perfusion and attenuates intestinal injury during exercise in athletes compared with placebo , probably by enhancing arginine availability .
CONCLUSIONS	These results suggest that oral L-citrulline supplementation is a promising intervention to combat splanchnic hypoperfusion-induced intestinal compromise .

###26156737
BACKGROUND	Vitamin D supplementation is recommended for breastfed infants .
BACKGROUND	Maternal supplementation beginning in gestation is a potential alternative , but its efficacy in maintaining infant 25-hydroxyvitamin D [ 25 ( OH ) D ] concentration after birth is unknown .
OBJECTIVE	We determined the effect of 3 doses of maternal vitamin D supplementation beginning in gestation and continued in lactation on infant serum 25 ( OH ) D and compared the prevalence of infant serum 25 ( OH ) D cutoffs ( > 30 , > 40 , > 50 , and > 75 nmol/L ) by dose at 8 wk of age .
METHODS	Pregnant women ( n = 226 ) were randomly allocated to receive 10 , 25 , or 50 g vitamin D/d from 13 to 24 wk of gestation until 8 wk postpartum , with no infant supplementation .
METHODS	Mother and infant blood was collected at 8 wk postpartum .
RESULTS	At 8 wk postpartum , mean [ nmol/L ( 95 % CI ) ] infant 25 ( OH ) D at 8 wk was higher in the 50-g/d [ 75 ( 67 , 83 ) ] than in the 25-g/d [ 52 ( 45 , 58 ) ] or 10-g/d [ 45 ( 38 , 52 ) ] vitamin D groups ( P < 0.05 ) .
RESULTS	Fewer infants born to mothers in the 50-g/d group had a 25 ( OH ) D concentration < 30 nmol/L ( indicative of deficiency ) than infants in the 25 - and 10-g/d groups , respectively ( 2 % compared with 16 % and 43 % ; P < 0.05 ) .
RESULTS	Fewer than 15 % of infants in the 10 - or 25-g/d groups achieved a 25 ( OH ) D concentration > 75 nmol/L compared with 44 % in the 50-g/d group ( P < 0.05 ) .
RESULTS	Almost all infants ( 98 % , n = 44 ) born to mothers in the 50-g/d group achieved a 25 ( OH ) D concentration > 30 nmol/L .
RESULTS	At 8 wk postpartum , mean maternal 25 ( OH ) D concentration was higher in the 50-g/d [ 88 ( 84 , 91 ) ] than in the 25-g/d [ 78 ( 74 , 81 ) ] or 10-g/d [ 69 ( 66 , 73 ) ] groups ( P < 0.05 ) .
CONCLUSIONS	Maternal supplementation beginning in gestation with 50 g vitamin D/d protects 98 % of unsupplemented breastfed infants against 25 ( OH ) D deficiency ( < 30 nmol/L ) to at least 8 wk , whereas 10 or 25 g vitamin D/d protects only 57 % and 84 % of infants , respectively .

###25503168
BACKGROUND	The MIRCIT trial was a randomized , double-blind , placebo-controlled study of advanced Non-small cell lung cancer ( NSCLC ) .
METHODS	Patients were randomized to receive 10 mg or 20 mg of melatonin or placebo .
METHODS	Assessment of health-related quality of life ( HRQoL ) was completed at baseline , and at 2 , 3 and 7 months .
METHODS	Survival and adverse events were collected .
METHODS	DNA damage marker 8-oxo-7 ,8 - dihydro-2 ' - deoxyguanosine ( 8-oxodG ) was measured during the first three months of chemotherapy .
RESULTS	Patients in the melatonin-treated group had better adjusted HRQoL scores , with a slightly significantly better score ( 2.69 points , 95 % confidence interval ( CI ) = 0.01-5 .38 , p = 0.049 ) being found in social well-being .
RESULTS	Median survival was 7.3 months ( 95 % CI = 3.42-11 .14 ) without significant difference .
RESULTS	A great amont of DNA damage marker was observed in the placebo-treated group , and this was associated with lower survival ( r ( 2 ) = -0.656 , p = 0.02 ) , implying the protective effect of melatonin in healthy cells .
CONCLUSIONS	Melatonin in combination with chemotherapy did not affect survival and adverse events of advanced patients with NSCLC , but there was a trend for better HRQoL .

###24552555
BACKGROUND	Modifiable risk factors , including life-style habits and psychological variables , have been increasingly demonstrated to have an important role in influencing morbidity and mortality in cardiovascular patients , and to account for approximately 90 % of the population risk for cardiac events.Acceptance and Commitment Therapy ( ACT ) has shown effectiveness in promoting healthy behaviors , and improving psychological well-being in patients with chronic physical conditions .
BACKGROUND	Moreover , a first application of an acceptance-based program in cardiac patients has revealed high treatment satisfaction and initial evidences of effectiveness in increasing heart-healthy behaviour .
BACKGROUND	However , no clinical trial to date has evaluated the efficacy of an acceptance-based program for the modification of cardiovascular risk factors and the improvement of psychological well-being , compared to usual secondary prevention care .
METHODS	Approximately 168 patients will be recruited from an outpatient cardiac rehabilitation unit and randomly assigned to receive usual care or usual care + a brief ACT-based intervention .
METHODS	The ACT group will be administered five group therapy sessions integrating educational topics on heart-healthy behaviours with acceptance and mindfulness skills .
METHODS	Participants will be assessed at baseline , six weeks later ( post treatment for the ACT condition ) , at six and twelve months follow-up .
METHODS	A partially-nested design will be used to balance effects due to clustering of participants into small therapy groups .
METHODS	Primary outcome measures will include biological indicators of cardiovascular risk and self-reported psychological well-being .
METHODS	Treatment effects will be tested via multilevel modeling after which the mediational role of psychological flexibility will be evaluated .
CONCLUSIONS	The ACTonHEART study is the first randomized clinical trial designed to evaluate the efficacy of a brief group-administered , ACT-based program to promote health behavior change and psychological well-being among cardiac patients .
CONCLUSIONS	Results will address the effectiveness of a brief treatment created to simultaneously impact multiple cardiovascular risk factors .
CONCLUSIONS	Conducted in the context of clinical practice , this trial will potentially offer empirical support to alternative interventions to improve quality of life and reduce mortality and morbidity rates among cardiac patients .
BACKGROUND	clinicaltrials.gov / ( NCT01909102 ) .

###24668572
OBJECTIVE	Compensatory responses may attenuate the effectiveness of exercise training in weight management .
OBJECTIVE	The aim of this study was to compare the effect of moderate - and high-intensity interval training on eating behavior compensation .
METHODS	Using a crossover design , 10 overweight and obese men participated in 4-week moderate ( MIIT ) and high ( HIIT ) intensity interval training .
METHODS	MIIT consisted of 5-min cycling stages at 20 % of mechanical work at 45 % VO ( 2 ) peak , and HIIT consisted of alternate 30-s work at 90 % VO ( 2 ) peak and 30-s rests , for 30 to 45 min .
METHODS	Assessments included a constant-load exercise test at 45 % VO ( 2 ) peak for 45 min followed by 60-min recovery .
METHODS	Appetite sensations were measured during the exercise test using a Visual Analog Scale .
METHODS	Food preferences ( liking and wanting ) were assessed using a computer-based paradigm , and this paradigm uses 20 photographic food stimuli varying along two dimensions , fat ( high or low ) and taste ( sweet or nonsweet ) .
METHODS	An ad libitum test meal was provided after the constant-load exercise test .
RESULTS	Exercise-induced hunger and desire to eat decreased after HIIT , and the difference between MIIT and HIIT in desire to eat approached significance ( p = .07 ) .
RESULTS	Exercise-induced liking for high-fat nonsweet food tended to increase after MIIT and decreased after HIIT ( p = .09 ) .
RESULTS	Fat intake decreased by 16 % after HIIT , and increased by 38 % after MIIT , with the difference between MIIT and HIIT approaching significance ( p = .07 ) .
CONCLUSIONS	This study provides evidence that energy intake compensation differs between MIIT and HIIT .

###24583315
OBJECTIVE	To determine if lower extremity exercise-induced muscle injury reduces vascular endothelial function of the upper extremity and if massage therapy ( MT ) improves peripheral vascular function after exertion-induced muscle injury .
METHODS	Randomized , blinded trial with evaluations at 90 minutes , 24 hours , 48 hours , and 72 hours .
METHODS	Clinical research center .
METHODS	Sedentary young adults ( N = 36 ) were randomly assigned to 1 of 3 groups : ( 1 ) exertion-induced muscle injury and MT ( n = 15 ; mean age SE , 26.6 0.3 ) ; ( 2 ) exertion-induced muscle injury only ( n = 10 ; mean age SE , 23.6 0.4 ) , and ( 3 ) MT only ( n = 11 ; mean age SE , 25.5 0.4 ) .
METHODS	Participants were assigned to exertion-induced muscle injury only ( a single bout of bilateral , eccentric leg press exercise ) , MT only ( 30-min lower extremity massage using Swedish technique ) , or exertion-induced muscle injury and MT.
METHODS	Brachial artery flow-mediated dilation ( FMD ) was determined by ultrasound at each time point .
METHODS	Nitroglycerin ( NTG ) - induced dilation was also assessed ( 0.4 mg ) .
RESULTS	Brachial FMD increased from baseline in the exertion-induced muscle injury and MT group and the MT only group ( 7.38 % .18 % to 9.02 % .28 % , P < .05 and 7.77 % .25 % to 10.2 % .22 % , P < .05 , respectively ) at 90 minutes and remained elevated until 72 hours .
RESULTS	In the exertion-induced muscle injury only group , FMD was reduced from baseline at 24 and 48 hours ( 7.78 % .14 % to 6.75 % .11 % , P < .05 and 6.53 % .11 % , P < .05 , respectively ) and returned to baseline after 72 hours .
RESULTS	Dilations of NTG were similar over time .
CONCLUSIONS	Our results suggest that MT attenuates impairment of upper extremity endothelial function resulting from lower extremity exertion-induced muscle injury in sedentary young adults .

###24454698
BACKGROUND	In research clinic settings , overweight adults undertaking HIIT ( high intensity interval training ) improve their fitness as effectively as those undertaking conventional walking programs but can do so within a shorter time spent exercising .
BACKGROUND	We undertook a randomized controlled feasibility ( pilot ) study aimed at extending HIIT into a real world setting by recruiting overweight/obese , inactive adults into a group based activity program , held in a community park .
METHODS	Participants were allocated into one of three groups .
METHODS	The two interventions , aerobic interval training and maximal volitional interval training , were compared with an active control group undertaking walking based exercise .
METHODS	Supervised group sessions ( 36 per intervention ) were held outdoors .
METHODS	Cardiorespiratory fitness was measured using VO2max ( maximal oxygen uptake , results expressed in ml/min/kg ) , before and after the 12 week interventions .
RESULTS	On ITT ( intention to treat ) analyses , baseline ( N = 49 ) and exit ( N = 39 ) [ Formula : see text ] O2 was 25.34.5 and 25.33.9 , respectively .
RESULTS	Participant allocation and baseline/exit VO2max by group was as follows : Aerobic interval training N = 16 , 24.24.8 / 25.64.8 ; maximal volitional interval training N = 16 , 25.02.8 / 25.23.4 ; walking N = 17 , 26.55.3 / 25.23.6 .
RESULTS	The post intervention change in VO2max was +1.01 in the aerobic interval training , -0.06 in the maximal volitional interval training and -1.03 in the walking subgroups .
RESULTS	The aerobic interval training subgroup increased VO2max compared to walking ( p = 0.03 ) .
RESULTS	The actual ( observed , rather than prescribed ) time spent exercising ( minutes per week , ITT analysis ) was 74 for aerobic interval training , 45 for maximal volitional interval training and 116 for walking ( p = 0.001 ) .
RESULTS	On descriptive analysis , the walking subgroup had the fewest adverse events .
CONCLUSIONS	In contrast to earlier studies , the improvement in cardiorespiratory fitness in a cohort of overweight/obese participants undertaking aerobic interval training in a real world setting was modest .
CONCLUSIONS	The most likely reason for this finding relates to reduced adherence to the exercise program , when moving beyond the research clinic setting .
BACKGROUND	ACTR.org.au ACTRN12610000295044 .

###24700467
BACKGROUND	In experimental animal studies , pulsing the CO2 laser beam has been shown to reduce the thermal damage zone of excised oral mucosal tissue .
BACKGROUND	However , there is still controversy over whether this is borne out under clinical conditions .
OBJECTIVE	To compare the outcome following excisional biopsies of fibrous hyperplasias using a pulsed ( cf ) versus a continuous wave ( cw ) CO2 laser mode regarding the thermal damage zone , duration of surgeries , intra - and postoperative complications , postoperative pain sensation , scarring and/or relapse during the initial 6 months .
METHODS	One hundred Swiss-resident patients with a fibrous hyperplasia in their buccal mucosa were randomly assigned to the cw mode ( 5W ) or the cf mode ( 140Hz , 400microseconds , 33mJ , 4.62 W ) group .
METHODS	All excisions were performed by one single oral surgeon .
METHODS	Postoperative pain ( 2 weeks ) was recorded by visual analogue scale ( VAS ; ranging from 0 to 100 ) .
METHODS	Intake of analgesics and postoperative complications were recorded in a standardized study form .
METHODS	The maximum width of the collateral thermal damage zone was measured ( m ) in excision specimens by one pathologist .
METHODS	Intraoral photographs at 6-month follow-up examinations were evaluated regarding scarring ( yes/no ) .
RESULTS	Median duration of the excision was 65seconds in the cw and 81seconds in the cf group ( P = 0.13 ) .
RESULTS	Intraoperative bleeding occurred in 16.3 % of the patients in the cw and 17.7 % of the cf group .
RESULTS	The median value of the thermal damage zone was 161 ( 228 ) m in the cw and 152 ( 105 ) m in the cf group ( P = 0.68 ) .
RESULTS	The reported postoperative complications included swelling in 19 % and minor bleeding in 6 % without significant differences between the two laser modes .
RESULTS	When comparing each day separately or the combined mean VAS scores of both groups between Days 1-3 , 1-7 , and 1-15 , there were no significant differences .
RESULTS	However , more patients of the cw group ( 25 % ) took analgesics than patients of the cf group ( 9.8 % ) resulting in a borderline significance ( P = 0.04 ) .
RESULTS	Scarring at the excision site was found in 50.6 % of 77 patients after 6 months , and more scars were identified in cases treated with the cf mode ( P = 0.03 ) .
CONCLUSIONS	Excision of fibrous hyperplasias performed with a CO2 laser demonstrated a good clinical outcome and long-term predictability with a low risk of recurrence regardless of the laser mode ( cf or cw ) used .
CONCLUSIONS	Scarring after 6 months was only seen in 50.6 % of the cases and was slightly more frequent in the cf mode group .
CONCLUSIONS	Based on the findings of the present study , a safety border of 1mm appears sufficient for both laser modes especially when performing a biopsy of a suspicious soft tissue lesion to ensure a proper histopathological examination .

###24559003
BACKGROUND	Patients with chronic kidney disease ( CKD ) show an increase in bowel aerobic bacteria that produce uremic toxins and decreased anaerobic bacteria as bifidobacteria and lactobacillus .
BACKGROUND	The latter can be used as probiotics .
BACKGROUND	The probiotic with greater availability in Mexico , is the lactobacillus casei shirota ( LcS ) , currently there is no known LcS specified dose that produces a benefit to the patient with CKD .
OBJECTIVE	To determine the effectiveness of two different LcS doses in achieving a decrease in urea concentrations of at least 10 % in patients with KDOQI stage 3 and stage 4 CKD .
OBJECTIVE	METODOLOGY : A simple randomized , controlled clinical trial .
OBJECTIVE	Outpatients treated at the National Institute of Medical Sciences and Nutrition Salvador Zubirn in Mxico D.F. Patients were provided the LcS , as follows : Group A : 8 x 10 ( 9 ) colony-forming units ( CFU ) and Group B : 16 x 10 ( 9 ) CFU .
OBJECTIVE	Patients were followed-up for eight weeks , and baseline and final samples were obtained to calculate the basal and final concentrations , respectively , of blood urea and serum creatinine ( CrS ) .
OBJECTIVE	During the follow-up , both groups consumed a diet of 30 kcal/kg/weight and 0.8 g/kg/weight of protein , and a food diary was made to assess both the adherence to the diet and LcS .
RESULTS	Thirty patients with CKD were evaluated .
RESULTS	When analyzing the percentage change between the different doses , a decrease > 10 % was found in the blood urea concentrations for patients treated with the 16 x 109 dose , which was significant with respect to the baseline measurement .
CONCLUSIONS	There was a > 10 % decrease in the serum urea concentrations with LcS in patients with stage 3 and 4 CRF .

###24417206
OBJECTIVE	SCN1A encodes the alpha subunit of the voltage-gated sodium channel and plays a crucial role in several epilepsy syndromes .
OBJECTIVE	The common SCN1A splice-site polymorphism rs3812718 ( IVS5N +5 G > A ) might contribute to the pathophysiology underlying genetic generalized epilepsies and is associated with electrophysiologic properties of the channel and the effect of sodium-channel blocking antiepileptic drugs .
OBJECTIVE	We assessed the effects of the rs3812718 genotype on cortical excitability at baseline and after administration of carbamazepine in order to investigate the mechanism of this association .
METHODS	Paired-pulse transcranial magnetic stimulation ( TMS ) was applied in 92 healthy volunteers with the homozygous genotypes AA or GG of rs3812718 at baseline and after application of 400mg of carbamazepine or placebo in a double-blind , randomized , crossover design .
METHODS	Resting motor threshold ( RMT ) , short interval intracortical inhibition ( SICI ) , intracortical facilitation ( ICF ) , and cortical silent period ( CSP ) were determined .
RESULTS	At baseline there was no significant difference in any TMS parameter .
RESULTS	Genotype GG was associated with a higher carbamazepine-induced increase in CSP duration as compared to AA ( multivariate analysis of covariance [ MANCOVA ] , p = 0.013 ) .
RESULTS	An expected significant increase in RMT was genotype independent .
CONCLUSIONS	We found that the rs3812718 genotype modifies the effect of carbamazepine on CSP duration ( mainly reflecting modulation of - aminobutyric acid ( GABA ) ergic inhibition ) , but not on RMT ( mainly reflecting modulation of voltage-gated sodium channels ) .
CONCLUSIONS	This provides evidence that rs3812718 affects the pharmacoresponse to carbamazepine via an effect on GABAergic cortical interneurons .
CONCLUSIONS	Our results also confirm that TMS is useful to investigate the effect of genetic variants on cortical excitability and pharmacoresponse .

###24262498
OBJECTIVE	We evaluate whether aspiration and sclerosing of hydrocele testis is an effective treatment .
METHODS	Men with symptomatic hydrocele testis were included in this prospective , double-blind , randomized study with polidocanol and placebo .
METHODS	Patients were randomized to active treatment or placebo at the first treatment .
METHODS	Depending on hydrocele testis size ( less than 100 , 100 to 200 and greater than 200 ml ) , the patients were treated with 1 , 3 or 4 ml polidocanol after aspiration .
METHODS	Patients with recurrence at the 5-week followup received active treatment .
RESULTS	A total of 77 patients were included in the study .
RESULTS	In group 1 ( active treatment ) there were 36 patients with a median age of 63 years ( range 34 to 92 ) .
RESULTS	In group 2 , comprised of 41 patients , the median age was 59 years ( range 26 to 82 ) .
RESULTS	Median followup was 72 months .
RESULTS	A significant difference between the groups was observed after the first and second treatments .
RESULTS	Recurrence after the first treatment was seen in 16 ( 44 % ) patients from group 1 and in 32 ( 78 % ) from group 2 ( p < 0.05 ) .
RESULTS	Recurrence after re-treatment with the active drug in both groups was seen in 4 ( 25 % ) patients in group 1 and in 14 ( 44 % ) in the former placebo group ( p < 0.05 ) .
RESULTS	The overall success rate of treatment in the active group was 89 % .
RESULTS	There was no difference between the 2 groups in terms of volume of fluid aspirated , symptoms or complications .
CONCLUSIONS	This long-term efficacy randomized study with placebo showed that polidocanol is effective for the treatment of hydrocele testis with a low recurrence rate .

###24655694
BACKGROUND	Although hypertension is a modifiable cardiovascular risk factor , up to one-third of ambulatory patients have uncontrolled blood pressure ( BP ) .
BACKGROUND	We evaluated the impact of a targeted provider feedback intervention on rates of BP control .
METHODS	Clinic BP readings were aggregated among approximately 3,000 hypertensive patients followed up in 42 outpatient cardiology clinic practices at a large quaternary care academic medical center .
METHODS	Physician practices received quarterly reports on BP control rates .
METHODS	Provider-specific reports were benchmarked vs overall peer performance and distributed quarterly between September 2011 and September 2012 .
METHODS	Rates of BP control were evaluated before and after the intervention .
METHODS	Medical record reviews were performed for a subset of patients with uncontrolled BP before ( n = 300 ) and after ( n = 300 ) the intervention to evaluate provider responses and interventions .
RESULTS	At baseline , 27.9 % of clinic patients had uncontrolled BP .
RESULTS	After one 1 of reports , the rate of uncontrolled BP remained unchanged ( 27.7 % , P = .86 ) .
RESULTS	Analysis of provider performance revealed a subset of providers who consistently outperform their peers .
RESULTS	In the sample of patients selected for medical record reviews , at baseline ( n = 300 ) and follow-up ( n = 300 ) , cardiologists discussed BP in 80 % of clinic notes for patients with uncontrolled BP .
RESULTS	Cardiologists more frequently documented repeat measurements after the intervention ( 28.0 % vs 35.7 % , P = .04 ) .
RESULTS	No other changes were found in documentation of provider responses to BP .
CONCLUSIONS	Clinician-specific audit and feedback reports as a stand-alone intervention did not affect overall BP control rates in cardiology clinics .
CONCLUSIONS	Future BP control interventions should consider real-time patient-specific reminders , provider incentive programs , and patient engagement interventions .

###24813776
OBJECTIVE	The object of this study was to assess the effects of an inside-out vein graft as a cuff after direct suture on human lingual nerve regeneration and recovery after iatrogenic lingual nerve injury .
METHODS	Ten patients with unilateral lingual nerve anesthesia as a complication of iatrogenic injury after third molar extraction underwent microneurosurgical procedures for the injured lingual nerve under general anesthesia .
METHODS	The patients were randomized into 2 groups .
METHODS	In group A , after removing the neuromas and peripheral scars surrounding the torn nerves , the 2 nerve ends were sutured without tension .
METHODS	In group B , after the same procedure , including the same suturing procedure , an inside-out vein graft was placed as a cuff after the direct suture .
METHODS	Each group was followed at least once every 6 months for 1 year after the procedure .
METHODS	Postoperative outcomes were evaluated using the Pogrel criteria , the Sunderland grade , and the British Medical Research Council Scale ( MRCS ) .
RESULTS	There were no particular differences between groups A and B at 6 and 12 months after the operation .
RESULTS	However , based on the MRCS criteria , there was a clearly better result in group B than in group A at 6 and 12 months after the operation , and the recovery of gustatory sensation tended to be better in group B than in group A 1 year after the operation .
CONCLUSIONS	This inside-out vein graft as a cuff after direct suturing may facilitate faster lingual nerve regeneration than the traditional direct suture approach .
CONCLUSIONS	The inside-out vein graft as a cuff may provide the advantages of preventing axonal escape at the suture lines , minimizing nerve entrapment , and preventing neuroma formation in the space between the sutured nerves .

###26455249
BACKGROUND	Primary percutaneous coronary intervention has improved the outcome of acute myocardial infarction ( AMI ) patients .
BACKGROUND	Counsel-guided sex rehabilitation efficacy in acute myocardial infarction patients receiving percutaneous coronary intervention remains unknown .
OBJECTIVE	The aim of the study was to study counsel-guided sex rehabilitation efficacy in AMI patients receiving percutaneous coronary intervention .
METHODS	240 AMI patients who received percutaneous coronary intervention were randomly divided into a control and a counselling group .
METHODS	Control group patients were given written sex rehabilitation instruction before discharge , while counselling group patients were given written instruction before discharge and monthly counselling with healthcare providers .
METHODS	Before discharge , the first evaluation was performed for frequency of and satisfaction with sexual activity before AMI .
METHODS	At one year of follow-up , the time of resuming , frequency of and satisfaction with sexual activity was evaluated .
METHODS	The main adverse event rates were also investigated .
RESULTS	No significant differences in age , sex , smoking status , hypertension , diabetes , PVD ( peripheral vascular disease ) , EF ( ejection fraction ) or GRACE ( Global Registry of Acute Coronary Events ) score were found between the groups .
RESULTS	Both groups suffered reduced frequency of and satisfaction with sexual activity after AMI as compared with prior to presentation with AMI .
RESULTS	However , compared with controls , the counselling group had higher scores for frequency of and satisfaction with sexual activity after AMI .
RESULTS	The time to resume sexual activity after AMI in the counselling group was significantly shorter than was found for the control group.There were no significant differences between the groups for recurrent AMI , non-fatal stroke , admitting the patient for angina , all-cause death or adverse events .
CONCLUSIONS	Intermittent discussions between healthcare providers and AMI patients improved resumption of sexual activity .
CONCLUSIONS	Encouraging patients who received complete coronary revascularization to resume sexual activity shortly after AMI was safe .

###24684838
OBJECTIVE	To identify the effects of anti-angiogenic therapy in neovascular age-related macular degeneration ( AMD ) in respect to morphologic type and time course and to identify prognostic factors for visual outcome on the basis of standardized optical coherence tomography ( OCT ) analysis .
METHODS	Subanalysis of a prospective , 12-month , multicenter , phase IIIb trial ( Efficacy and Safety of Ranibizumab in Patients with Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration [ EXCITE ] ) .
METHODS	A total of 353 treatment-nave patients with subfoveal choroidal neovascularization ( CNV ) receiving quarterly or monthly ranibizumab therapy .
METHODS	Patients were randomized to receive 0.3 mg quarterly , 0.5 mg quarterly , or 0.3 mg monthly doses of ranibizumab .
METHODS	Treatment comprised a loading phase of 3 consecutive monthly injections followed by a 9-month maintenance phase of monthly or quarterly injections .
METHODS	Best-corrected visual acuity ( BCVA ) was measured using the Early Treatment Diabetic Retinopathy Study protocol , and retinal morphology was assessed by Stratus OCT ( Carl Zeiss Meditec , Dublin , CA ) .
METHODS	Imaging data were evaluated by certified examiners of the Vienna Reading Center using a standardized protocol .
METHODS	The BCVA was measured using ETDRS charts and retinal morphology was assessed by OCT. .
RESULTS	During the loading phase , there was a significant correlation between a reduction in central retinal thickness and an increase in BCVA ( P < 0.001 ) , which decreased during the maintenance phase in all treatment arms .
RESULTS	The proportion of patients showing retinal morphologic changes , such as intraretinal cysts ( IRCs ) , subretinal fluid ( SRF ) , and pigment epithelial detachments ( PEDs ) , decreased significantly in all groups ( P < 0.001 ) , more intensively in the 0.5 mg quarterly than in both 0.3 mg groups .
RESULTS	Intraretinal cysts resolved most rapidly followed by SRF , whereas PED decreased at a slower rate and intensity .
RESULTS	Patients with IRC at baseline had lower BCVA levels that remained lower over the entire study period , whereas recurrence of IRC during follow-up showed no additional negative effect on function .
RESULTS	Baseline SRF had no effect on visual recovery ; however , recurrence of SRF during follow-up showed a tendency for an additional negative effect on function ( P = 0.06 ) .
RESULTS	Baseline PED showed a negative influence on visual outcome only in combination with IRC and SRF .
CONCLUSIONS	There is a distinct response pattern and time course of morphologic parameters associated withanti-vascular endothelial growth factor therapy in neovascular AMD .
CONCLUSIONS	Specific alterations , such as IRC , SRF , andPED , as baseline or follow-up features are significantly influencing the potential for visual gain .

###24828894
OBJECTIVE	There is ongoing controversy regarding a ` J-curve ' phenomenon such that low and high blood pressure ( BP ) levels are associated with increased risks of recurrent stroke .
OBJECTIVE	We aimed to determine whether large treatment-related BP reductions are associated with increased risks of recurrent stroke .
METHODS	Data are from the PROGRESS trial , where 6105 patients with cerebrovascular disease were randomly assigned to either active treatment ( perindopril indapamide ) or placebo ( s ) .
METHODS	There were no BP criteria for entry .
METHODS	BP was measured at every visit , and participant groups defined by reduction in systolic BP ( SBP ) from baseline were used for the analyses .
METHODS	Outcome was recurrent stroke .
RESULTS	During a mean follow-up of 3.9 years , 727 recurrent strokes were observed .
RESULTS	There were clear associations between the magnitude of SBP reduction and the risk of recurrent stroke .
RESULTS	After adjustment for cardiovascular risk factors and randomised treatment , annual incidence was 2.08 % , 2.10 % , 2.31 % and 2.96 % for participant groups defined by SBP reductions of 20 , 10-19 , 0-9 and < 0 mm Hg , respectively ( p = 0.0006 for trend ) .
CONCLUSIONS	The present analysis provided no evidence of an increase in recurrent stroke associated with larger reductions in SBP produced by treatment among patients with cerebrovascular disease .

###25197734
OBJECTIVE	To evaluate and compare the effect of triphala extract mouthrinse and chlorhexidine on dental plaque and gingivitis .
METHODS	In this double blind , crossover study , 120 qualifying boarding-school students aged 13-16 years were randomised into three groups : 10 % triphala , 0.2 % chlorhexidine and negative control .
METHODS	The study was conducted in 3 phases of 1-month duration each and a washout period of 15 days .
METHODS	During the experimental period , subjects rinsed with the allocated mouthrinse once daily for 30 s under supervision .
METHODS	The plaque and gingival status was assessed using the Turesky modification of the Quigley and Hein plaque index ( QHI ) and the gingival index ( Le and Silness ) at baseline and at the end of each phase .
METHODS	The results were tested for significance at P < 0.05 .
RESULTS	Triphala and chlorhexidine yielded a significant reduction in plaque and gingival index scores as compared to negative control ( P < 0.001 ) .
RESULTS	No significant difference was found between the scores obtained with triphala and chlorhexidine mouthwashes .
CONCLUSIONS	The antiplaque and antigingivitis activity of triphala closely parallels that of chlorhexidine .

###26024110
OBJECTIVE	Placental growth factor ( PlGF ) has been implicated as a contributor to resistance against anti-VEGF therapy .
OBJECTIVE	The purpose of the present study was to analyze the systemic levels of PlGF , VEGF-A , and VEGF-B in patients with neovascular age-related macular degeneration ( AMD ) after treatment with aflibercept , ranibizumab , or bevacizumab .
METHODS	Totals of 19 patients were treated with intravitreal aflibercept , 19 with ranibizumab , and 18 with bevacizumab .
METHODS	The cytokine levels were measured by ELISA just before the injection , and 7 days and 1 month thereafter .
METHODS	Age - and sex-matched participants ( n = 22 ) served as controls .
RESULTS	The median PlGF plasma concentration at baseline was < 12.0 pg/mL in the control group as well as in all three anti-VEGF treatment cohorts .
RESULTS	After intravitreal aflibercept injection , a significant upregulation of systemic PlGF could be observed in all treated patients ( 38.0 [ 31.0-44 .0 ] pg/mL after 1 week [ P < 0.001 ] and 16.0 [ 0.0-19 .0 ] pg/mL [ P = 0.005 ] after 4 weeks ) .
RESULTS	No significant effects on plasma PlGF concentrations could be detected in those treated with ranibizumab and bevacizumab .
RESULTS	The systemic VEGF-A levels were significantly reduced 1 and 4 weeks after intravitreal aflibercept ( P < 0.001 , P < 0.001 ) and bevacizumab ( P < 0.001 , P < 0.01 ) injections .
RESULTS	No significant effects on plasma cytokine concentrations could be observed in the ranibizumab cohort .
RESULTS	No significant effects on systemic VEGF-B could be observed in any of the treatment groups .
CONCLUSIONS	In this study , we report a significant systemic upregulation of the proangiogenic cytokine PlGF after intravitreal administration of aflibercept .
CONCLUSIONS	This might represent a counter-regulatory response to antiangiogenic therapy .

###25010302
OBJECTIVE	To determine the influence of arm-crank exercise in reproductive hormone levels in adults with chronic SCI .
OBJECTIVE	Further objectives were to assess the influence of arm-crank exercise on muscle strength and body composition .
METHODS	Seventeen male adults with complete SCI at or below the 5th thoracic level ( T5 ) volunteered for this study .
METHODS	Participants were randomly allocated to the intervention ( n = 9 ) or control group ( n = 8 ) using a concealed method .
METHODS	The participants in the intervention group performed a 12-week arm-crank exercise program , 3 sessions/week , consisting of warming-up ( 10-15 min ) followed by a main part in arm-crank ( 20-30 min [ increasing 2 min and 30 seconds each three weeks ] ) at a moderate work intensity of 50-65 % of heart rate reserve ( HRR ) ( starting at 50 % and increasing 5 % each three weeks ) and by a cooling-down period ( 5-10 min ) .
METHODS	Serum follicle-stimulating hormone ( FSH ) , luteinizing hormone ( LH ) , testosterone and estradiol were determined by ELISA .
METHODS	Muscle strength ( handgrip ) and body composition ( waist circumference [ WC ] ) were assessed .
RESULTS	After the completion of the training program , testosterone level was significantly increased ( p = 0.0166 ;d = 1.14 ) .
RESULTS	Furthermore , maximal handgrip and WC were significantly improved .
RESULTS	Lastly , a significant inverse correlation was found between WC and testosterone ( r = - 0.35 ; p = 0.0377 ) .
CONCLUSIONS	The arm-crank exercise improved reproductive hormone profile by increasing testosterone levels in adults with chronic SCI .
CONCLUSIONS	A secondary finding was that it also significantly improved muscle strength and body composition in this group .

###25279781
OBJECTIVE	Scleral gas-permeable lenses are rapidly gaining international popularity .
OBJECTIVE	Unlike corneal gas-permeable lenses , scleral lenses are fitted to the bulbar conjunctiva and settle into the tissue after insertion .
OBJECTIVE	To date , we are unaware of any studies examining the settling behavior of three varying scleral lens designs .
OBJECTIVE	The purpose of this study was to quantify the mean total settling and mean rates of settling for three scleral lens designs : Onefit P&A ( Blanchard Contact Lens , Inc ) , Mini Scleral Design ( msd ) ( Blanchard Contact Lens , Inc ) , and Jupiter ( Visionary Optics ) .
METHODS	A randomized , repeated-measures study of Onefit P&A , msd , and Jupiter was performed .
METHODS	Subjects were fitted from a trial lens set , according to the manufacturer 's guidelines .
METHODS	After insertion , lens settling was measured at 0 minutes , 15 minutes , 30 minutes , 45 minutes , 1 hour , 2 hours , 4 hours , 6 hours , and 8 hours .
METHODS	Statistical analyses were performed using analysis of variance and two-stage , nonlinear regression analyses of settling over time .
RESULTS	On average , the Onefit P&A , msd , and Jupiter lenses settled a total of 113.7 , 133.7 , and 88.1 m , respectively .
RESULTS	Although the rates of settling were not linear , analysis of variance revealed a significant difference in the average settling rates ( p < 0.05 ) among the groups .
RESULTS	Tukey analyses revealed a significant difference in the settling rates for msd and Jupiter comparison ( p < 0.05 ) .
RESULTS	Nonlinear regression analyses predicted that the lenses settled to about 80 % of the final estimated values for the Onefit P&A lens , 90 % for msd , and 99 % for the Jupiter , after 8 hours .
CONCLUSIONS	We concluded that the amount of settling varied significantly among the three lens designs .
CONCLUSIONS	Settling rates were greatest shortly after insertion .
CONCLUSIONS	Larger lenses were estimated to be settled by 8 hours .
CONCLUSIONS	Based on the results of this short-term study , careful consideration to the settling patterns of individual scleral lens designs should be given .

###25116574
BACKGROUND	A healthy lifestyle may protect against cognitive decline .
BACKGROUND	We examined outcomes in elderly individuals after 18 months of a five-group intervention program consisting of various modalities to prevent cognitive decline .
METHODS	We conducted a cluster randomized controlled trial assessing 460 community-dwelling individuals aged 60 years and older in a geriatric community mental health center in Suwon , Republic of Korea , between 2008 and 2010 .
METHODS	We developed an intervention program based on the principles of contingency management , which could be delivered by ordinary primary health workers .
METHODS	Group A ( n = 81 ) received standard care services .
METHODS	Group B ( n = 80 ) received bimonthly ( once every 2 months ) telephonic care management .
METHODS	Group C ( n = 111 ) received monthly telephonic care management and educational materials similar to those in group B. Group D ( n = 93 ) received bimonthly health worker-initiated visits and counseling .
METHODS	Group E ( n = 94 ) received bimonthly health worker-initiated visits , counseling , and rewards for adherence to the program .
RESULTS	The primary outcome was the change in Mini-Mental State Examination ( MMSE ) scores from baseline to the final follow-up visit at 18 months .
RESULTS	Group E showed superior cognitive function to group A ( adjusted coefficient = 0.99 , p = 0.044 ) , with participation in cognitive activities being the most important determining factor among several health behaviors ( adjusted coefficient = 1.04 , p < 0.01 ) .
CONCLUSIONS	Engaging in cognitive activities , in combination with positive health behaviors , may be most beneficial in preserving cognitive abilities in community-dwelling older adults .

###25528738
BACKGROUND	Omalizumab , an anti-IgE monoclonal antibody , is administered by injection once or twice monthly in offices and clinics .
BACKGROUND	It offers a potential alternative intervention for patients with allergic asthma that is not well controlled because of recalcitrant poor adherence to inhaled corticosteroid therapy .
OBJECTIVE	To assess the effect of omalizumab therapy by measuring airway responsiveness to adenosine , a marker of allergic airway inflammation , and resource use .
METHODS	Patients ( N = 17 ) aged 6 to 26 years ( mean age , 16.4 years ) with poorly controlled persistent allergic asthma , less than 50 % adherence to inhaled corticosteroid therapy , a forced expiratory volume in 1 second ( FEV1 ) of 60 % predicted or higher , and adenosine provocation concentration that caused a decrease in FEV1 of 20 % ( PC20 ) of 60 mg/mL or less were randomized to receive 4 months of omalizumab or placebo in a double-blind , crossover trial with a 3 - to 4-month washout between treatments .
METHODS	Patients were instructed to continue taking inhaled corticosteroids throughout the study .
METHODS	The PC20 was measured before and after each period .
RESULTS	Fifteen patients completed the study .
RESULTS	The mean baseline PC20 was 14.1 mg/mL ( 95 % CI , 10.8-18 .4 mg/mL ) .
RESULTS	The fold change PC20 was 0.9 ( 95 % CI , 0.5-1 .7 ) during placebo and 3.1 ( 95 % CI , 1.6-6 .2 ) during omalizumab treatment ; the estimated ratio was 3.4 ( 95 % CI , 1.2-9 .3 ; P = .02 ) .
RESULTS	Six patients required one or more short courses of oral corticosteroids for asthma exacerbations during placebo , but none required this intervention during omalizumab .
RESULTS	During the study , the median prescription refills for inhaled corticosteroids was 0.15 ( 95 % CI , 0.00-0 .33 ) canisters per month .
CONCLUSIONS	Omalizumab therapy is an alternative for patients with more severe poorly controlled asthma in whom adherence does not improve with conventional interventions .
BACKGROUND	clinicaltrials.gov Identifier : NCT00133042 .

###24613825
OBJECTIVE	To evaluate visual acuity outcomes after cataract surgery in persons with varying degrees of severity of age-related macular degeneration ( AMD ) .
METHODS	Cohort study .
METHODS	A total of 1232 eyes of 793 participants who underwent cataract surgery during the Age-Related Eye Disease Study 2 , a prospective , multicenter , randomized controlled trial of nutritional supplements for treatment of AMD .
METHODS	Preoperative and postoperative characteristics of participants who underwent cataract extraction during the 5-year trial were analyzed .
METHODS	Both clinical data and standardized red-reflex lens and fundus photographs were obtained at baseline and annually .
METHODS	Photographs were graded by a centralized reading center for cortical and posterior subcapsular lens opacities and for AMD severity .
METHODS	Cataract surgery was documented at annual study visits or by history during the 6-month telephone calls .
METHODS	Analyses were conducted using multivariate repeated-measures regression .
METHODS	Change in best-corrected visual acuity ( BCVA ) after cataract surgery compared with preoperative BCVA .
RESULTS	Adjusting for age at time of surgery , gender , interval between preoperative and postoperative visits , and type and severity of cataract , the mean changes in visual acuity were as follows : eyes with mild AMD ( n = 30 ) gained 11.2 letters ( 95 % confidence interval [ CI ] , 6.9-15 .5 ) , eyes with moderate AMD ( n = 346 ) gained 11.1 letters ( 95 % CI , 9.1-13 .2 ) , eyes with severe AMD ( n = 462 ) gained 8.7 letters ( 95 % CI , 6.7-10 .7 ) , eyes with noncentral geographic atrophy ( n = 70 ) gained 8.9 letters ( 95 % CI , 5.8-12 .1 ) , and eyes with advanced AMD ( central geographic atrophy , neovascular disease , or both ; n = 324 ) gained 6.8 letters ( 95 % CI , 4.9-8 .8 ) .
RESULTS	The visual acuity gain across all AMD severity groups was statistically significant from preoperative values ( P < 0.0001 ) .
CONCLUSIONS	Mean visual acuities improved significantly after cataract surgery across varying degrees of AMD severity .

###25262253
OBJECTIVE	The objective of this study is to compare the effects of 2 types of diuretics , indapamide and hydrochlorothiazide , added to an angiotensin-converting enzyme inhibitor , on ventricular and arterial functions in patients with hypertension and diabetes .
METHODS	This is a prospective , randomized , active-controlled , PROBE design study in 56 patients ( 57 9 years , 52 % men ) with mild-to-moderate hypertension and type 2 diabetes , with normal ejection fraction , randomized to either indapamide ( 1.5 mg Slow Release ( SR ) / day ) or hydrochlorothiazide ( 25 mg/d ) , added to quinapril ( 10-40 mg/d ) .
METHODS	All patients had conventional , tissue Doppler and speckle tracking echocardiography and assessment of endothelial and arterial functions and biomarkers , at baseline and after 6 months .
RESULTS	Baseline characteristics were similar between groups ; systolic and diastolic blood pressures decreased similarly , by 15 % and 9 % on indapamide and by 17 % and 10 % on hydrochlorothiazide ( P < .05 ) .
RESULTS	Mean longitudinal systolic velocity and longitudinal strain increased by 7 % and 14 % on indapamide ( from 5.6 1.8 to 6.0 1.1 cm/s and from 16.2 % 1.8 % to 18.5 % 1.1 % , both P < .05 ) , but did not change on hydrochlorothiazide ( P < .05 for intergroup differences ) , whereas ejection fraction and radial systolic function did not change .
RESULTS	Similarly , mean longitudinal early diastolic velocity increased by 31 % on indapamide ( P < .05 ) , but did not change on hydrochlorothiazide ( P < .05 for intergroup differences ) .
RESULTS	These changes were associated with improved endothelial and arterial functions on indapamide , but not on hydrochlorothiazide .
CONCLUSIONS	Indapamide was found to improve measures of endothelial and arterial functions and to increase longitudinal left ventricular function compared with hydrochlorothiazide in patients with hypertension and diabetes , after 6 months of treatment .
CONCLUSIONS	This study suggests that indapamide , a thiazide-like diuretic , has important vascular effects that can improve ventriculoarterial coupling .

###25440809
BACKGROUND	There is a strong correlation between adverse clinical events and peak values of myocardial necrosis markers in non-ST-elevation acute coronary syndrome patients .
BACKGROUND	In this clinical setting , high-dose statin treatment exerts acute beneficial effects against renal and myocardial damage .
BACKGROUND	The aim of this report was to evaluate if , on admission , high-dose rosuvastatin can exert cardioprotective effects when administered in addition to high-dose clopidogrel .
METHODS	In the PRATO-ACS trial , 504 consecutive statin-nave non-ST-elevation acute coronary syndrome patients scheduled for early invasive strategy and pretreated with high-dose clopidogrel were randomly assigned to rosuvastatin ( 40 mg on admission followed by 20 mg/d ; statin group , n = 252 ) or no statin treatment ( control group , n = 252 ) .
METHODS	Serial myocardial biomarker samples were collected before and after angiography and/or percutaneous coronary intervention .
METHODS	The primary end point was the peak level of cardiac troponin I ( cTnI ) during the index event .
RESULTS	Statin-treated patients presented median cTnI peak values similar to controls ( 3.9 [ 0.6-12 .8 ] vs 3.5 [ 1.2-11 .9 ] ng/mL , respectively ; P = .60 ] ; no differences were found between the 2 groups in cTnI and creatine kinase-MB values at any time point , in either preangiography and postangiography peak values or their cumulative release .
RESULTS	In patients submitted to percutaneous coronary intervention , periprocedural myocardial infarction occurred in 8 ( 4.7 % ) of 171 statin-treated and 7 ( 4.3 % ) of 162 control patients ( P = .87 ) .
CONCLUSIONS	In the PRATO-ACS trial , early high-dose rosuvastatin did not show cardioprotective effects when administered in addition to high-dose clopidogrel .

###24333493
OBJECTIVE	The goal of this study was to evaluate the pharmacodynamic effects of switching patients from ticagrelor to prasugrel .
BACKGROUND	Clinicians may need to switch between more potent P2Y12 inhibitors because of adverse effects or switch to the use of a once-daily dosing regimen due to compliance issues .
METHODS	After a 3 - to 5-day run-in phase with a ticagrelor 180-mg loading dose ( LD ) followed by a ticagrelor 90-mg twice-daily maintenance dose ( MD ) , aspirin-treated patients ( N = 110 ) with stable coronary artery disease were randomized to continue ticagrelor or switch to prasugrel 10-mg once-daily MD , with or without a 60-mg LD .
METHODS	Pharmacodynamic assessments were defined according to P2Y12 reaction unit ( PRU ) ( P2Y12 assay ) and platelet reactivity index ( vasodilator-stimulated phosphoprotein phosphorylation assay ) at baseline ( before and after the run-in phase ) and 2 , 4 , 24 , and 48 h and 7 days after randomization .
RESULTS	Platelet reactivity was significantly greater at 24 and 48 h after switching to prasugrel versus continued therapy with ticagrelor , although to a lesser extent in those receiving an LD .
RESULTS	Mean PRU remained significantly higher in the combined prasugrel groups versus the ticagrelor group ( least-squares mean difference : 46 [ 95 % confidence interval 25 to 67 ] ) and did not meet the primary noninferiority endpoint ( upper limit of the confidence interval 45 ) , although PRU in the prasugrel cohort was lower at 7 days than at 24 or 48 h. Accordingly , rates of high on-treatment platelet reactivity were higher at 24 and 48 h in both prasugrel groups .
RESULTS	At 7 days , there was no difference in high on-treatment platelet reactivity rate between the combined prasugrel and ticagrelor groups .
CONCLUSIONS	Compared with continued ticagrelor therapy , switching from ticagrelor to prasugrel therapy was associated with an increase in platelet reactivity that was partially mitigated by the administration of an LD .

###24860180
BACKGROUND	Low-density lipoprotein ( LDL ) cholesterol is a strong risk factor for atherosclerosis but has an inverse association with atrial fibrillation ( AF ) .
BACKGROUND	We aimed to provide insight into the paradoxical association of LDL cholesterol with AF by evaluating the relationship of various lipoprotein measures and incident AF .
RESULTS	We prospectively evaluated lipoprotein measures among 23 738 healthy middle-aged and older women ( median follow-up 16.4 years ; N = 795 incident AF events ) .
RESULTS	Baseline LDL cholesterol was directly measured , lipoprotein particle concentrations and size were measured by nuclear magnetic resonance spectroscopy , and apolipoproteins were measured by immunoassay .
RESULTS	Cox regression models were adjusted for age , AF risk factors , inflammatory , and dysglycemic biomarkers .
RESULTS	After multivariable adjustment , inverse associations with AF were observed ( hazard ratio , 95 % confidence interval for top versus bottom quintile , P value ) for LDL cholesterol ( 0.72 , 0.56-0 .92 , P = 0.009 ) , the total number of LDL particles ( 0.77 , 0.60-0 .99 , P = 0.045 ) , and very-low-density lipoprotein particles ( 0.78 , 0.61-0 .99 , P = 0.04 ) , which was driven by the number of cholesterol-poor small LDL ( 0.78 , 0.61-1 .00 , P = 0.05 ) and small very-low-density lipoprotein particles ( 0.78 , 0.62-0 .99 , P = 0.04 ) .
RESULTS	By contrast , the larger cholesterol-rich LDL particles and all high-density lipoprotein measures were not associated with AF in multivariable models .
RESULTS	Adjustment for inflammatory and dysglycemic biomarkers had minimal impact on these associations .
CONCLUSIONS	In this prospective study , the inverse association between LDL cholesterol and AF extended to several other atherogenic lipoproteins , and these associations are unlikely to be mediated by direct cholesterol effects .
BACKGROUND	ClinicalTrials.gov ; Unique Identifier : NCT00000479 .

###25518117
OBJECTIVE	To observe the clinical effects of acupoint injection of metoclopramide for postsurgical gastroparesis syndrome ( PGS ) .
METHODS	A total of 46 patients with PGS ( from abdominal surgery ) were randomly divided into control and acupoint injection groups ( n = 23 in each group ) .
METHODS	Patients of the acupoint injection group were treated by injection of Metoclopramide ( 5 mg + normal saline ) into bilateral Zusanli ( ST 36 ) and Weishu ( BL 21 ) alternatively , while patients of the control group treated by injection of 10 mg of Metoclopramide into the deltoid muscle and gluteus maximus muscle alternatively .
METHODS	The treatment of both groups was conducted once daily for 14 days .
METHODS	A 3-point scale of clinical symptoms ( abdominal distension , belching , nausea-vomiting , upper-abdominal distending pain , sour regurgitation and gastric burning sensation ) was used to evaluate the therapeutic effect .
RESULTS	There were no statistical differences between two groups in clinical symptom scores before the treatment ( P > 0.05 ) .
RESULTS	Following treatment , the clinical symptom scores of both groups were significantly decreased in comparison with pre-treatment ( P < 0.05 ) and the scores of the acupoint injection group were significantly lower than those of the control group ( P < 0.05 ) .
RESULTS	Of the 23 PGS patients in the control group and acupoint injection group , 0 and 2 were cured , 5 and 10 were significantly improved , 10 and 9 were improved , 8 and 2 failed , with the effective rates being 65.22 % and 91.30 % , respectively .
CONCLUSIONS	Acupoint injection of Metoclopramide is effective for improving clinical symptoms of PGS patients .

###25305156
OBJECTIVE	To examine the association between brain structural changes and - amyloid deposition , and incident dementia in 183 elderly subjects without dementia ( mean age 85.5 years ) 2 years later .
METHODS	Subjects had a brain structural MRI scan and a PET scan with ( 11 ) C-labeled Pittsburgh compound B ( PiB ) in 2009 , and were evaluated clinically in 2011 .
RESULTS	At baseline evaluation , of the 183 participants ( 146 cognitively normal [ CN ] ) ; 37 mild cognitive impairment [ MCI ] ) , 139 ( 76 % ) were PiB + , had small hippocampal volume ( < 25th percentile ) , or had high white matter lesion ( WML ) volume ( > 75th percentile ) .
RESULTS	Two years later , 111 ( 61 % ) were classified as CN , 51 ( 28 % ) as MCI , and 21 ( 11 % ) as dementia .
RESULTS	At baseline , 51 % of the CN participants and 67.5 % of the MCI cases were PiB + .
RESULTS	Thirty percent of the CN and 51 % of the MCI cases had small hippocampi , and 24 % of the CN and 40.5 % of the MCI cases had abnormal WMLs .
RESULTS	Of the 21 participants who progressed to dementia , 20 ( 95 % ) had at least one imaging abnormality .
RESULTS	Only 3 ( 14 % ) were only PiB + , 1 ( 5 % ) had only small hippocampi , 1 ( 5 % ) had only WMLs , 1 ( 5 % ) was biomarker negative , and the other 16 had various pairs of imaging abnormalities .
RESULTS	Continuous variables of PiB retention , left and right hippocampal volume , and WML volume were independent predictors of dementia in a logistic regression analysis controlling for age , sex , education level , and Mini-Mental State Examination scores .
CONCLUSIONS	The prevalence of - amyloid deposition , neurodegeneration ( i.e. , hippocampal atrophy ) , and small vessel disease ( WMLs ) is high in CN older individuals and in MCI .
CONCLUSIONS	A combination of 2 or 3 of these factors is a powerful predictor of short-term incidence of dementia .

###24743706
BACKGROUND	Molecular characteristics of cancer vary between individuals .
BACKGROUND	In future , most trials will require assessment of biomarkers to allocate patients into enriched populations in which targeted therapies are more likely to be effective .
BACKGROUND	The MRC FOCUS3 trial is a feasibility study to assess key elements in the planning of such studies .
METHODS	Patients with advanced colorectal cancer were registered from 24 centres between February 2010 and April 2011 .
METHODS	With their consent , patients ' tumour samples were analysed for KRAS/BRAF oncogene mutation status and topoisomerase 1 ( topo-1 ) immunohistochemistry .
METHODS	Patients were then classified into one of four molecular strata ; within each strata patients were randomised to one of two hypothesis-driven experimental therapies or a common control arm ( FOLFIRI chemotherapy ) .
METHODS	A 4-stage suite of patient information sheets ( PISs ) was developed to avoid patient overload .
RESULTS	A total of 332 patients were registered , 244 randomised .
RESULTS	Among randomised patients , biomarker results were provided within 10 working days ( w.d. ) in 71 % , 15w .
RESULTS	d. in 91 % and 20w .
RESULTS	d. in 99 % .
RESULTS	DNA mutation analysis was 100 % concordant between two laboratories .
RESULTS	Over 90 % of participants reported excellent understanding of all aspects of the trial .
RESULTS	In this randomised phase II setting , omission of irinotecan in the low topo-1 group was associated with increased response rate and addition of cetuximab in the KRAS , BRAF wild-type cohort was associated with longer progression-free survival .
CONCLUSIONS	Patient samples can be collected and analysed within workable time frames and with reproducible mutation results .
CONCLUSIONS	Complex multi-arm designs are acceptable to patients with good PIS .
CONCLUSIONS	Randomisation within each cohort provides outcome data that can inform clinical practice .

###25154994
OBJECTIVE	To compare the efficacies of internal fixation by elastic intramedullary nail versus conventional plate osteosynthesis in the treatment of both radius and ulna fractures in children .
METHODS	A total of 84 cases were randomly divided into control and experimental groups at our department from July 2007 to 2013 .
METHODS	The control group underwent conventional plating while the experimental group received elastic intramedullary nail .
METHODS	Preoperative preparations and postoperative rehabilitation protocols were similar .
METHODS	The operative outcomes were evaluated from pain score at Day 3 post-operation , radiology and forearm curative function , local wound healing after 2 , 4 , 8 weeks , 3 , 6 months and 1 year .
RESULTS	Local wound healing time , radiology and forearm curative function had statistical significance between two groups ( P < 0.05 ) .
RESULTS	And the pain score had significant difference ( P < 0.01 ) .
CONCLUSIONS	Elastic intramedullary nail has multiple advantages of mini-invasiveness , quicker healing and excellent function recovery in the treatment of both ulna and radius fractures in children .

###25496342
BACKGROUND	As the second commonest cause of death and a major cause of disability worldwide , stroke has greatly influenced patients ' quality of life and created a huge public health burden .
BACKGROUND	As a special form of physical activity that has been widely practiced in China , and even throughout the world , Tai Chi may be favorable for the rehabilitation of stroke patients .
BACKGROUND	Several studies have been conducted to investigate the rehabilitative effects of Tai Chi for stroke patients , but none of them have been focused on the recovery phase ( 2 to 24 weeks ) of stroke .
METHODS	This study is an assessor-blinded randomized controlled trial .
METHODS	A total of 50 eligible participants will be randomly assigned to either a control group or a Tai Chi group .
METHODS	Patients in the control group will receive standard , conventional rehabilitation therapies , and a combination of Tai Chi and conventional rehabilitation programs will be applied in the Tai Chi group .
METHODS	The recovery of motor impairment , functional activity and balance abilities as measured with the Fugl-Meyer Assessment , Barthel Index and Berg Balance Scale will be assessed as primary outcome measures .
METHODS	The secondary outcome measures to be used are the scores on the Stroke-Specific Quality of Life Scale , the National Institutes of Health Stroke Scale and the objective parameters of the RSscan footscan gait system .
METHODS	All assessments will be conducted at baseline , 4 weeks after the rehabilitation course and at the end of 3-month follow-up .
CONCLUSIONS	The results of this study will provide preliminary evidence regarding the efficacy and feasibility of Tai Chi as an additional rehabilitative program for stroke patients in the recovery phase .
BACKGROUND	Chinese Clinical Trial Register ID : ChiCTR-TRC-13003661 ( 7 October 2013 ) .

###25307169
BACKGROUND	Omega-3 polyunsaturated fatty acid ( PUFA ) may benefit humans and animals with chronic inflammatory diseases .
OBJECTIVE	Omega-3 PUFA supplementation improves clinical signs , lung function , and airway inflammation in horses with recurrent airway obstruction ( RAO ) and inflammatory airway disease ( IAD ) .
METHODS	Eight research horses and 35 client-owned horses .
METHODS	A pilot study examined the dose of PUFA that can alter plasma PUFA composition .
METHODS	Then , a randomized , controlled clinical trial was performed in horses with RAO and IAD .
METHODS	Horses were fed a complete pelleted diet with no hay and randomly assigned to 1 of 3 daily treatments for 2 months : 30 or 60 g of the supplement or 30 g of placebo .
METHODS	Clinical signs , lung function , plasma PUFA composition , and bronchoalveolar lavage fluid ( BALF ) cytology were evaluated .
METHODS	Data were expressed as median ( 25-75th percentiles ) .
METHODS	P < .05 was considered significant .
RESULTS	Polyunsaturated fatty acid supplementation resulted in increased plasma docosahexaenoic acid ( DHA ) that peaked at 4 weeks .
RESULTS	Clinical improvement was noted in all horses involved in the clinical trial , but the group that received PUFA had greater improvement in clinical signs ( cough score improved 60 % ) , lung function ( respiratory effort decreased 48 % ) , and BALF ( neutrophils decreased from 23 to 9 % ) when compared to placebo ( cough score improved 33 % , respiratory effort decreased 27 % , BALF neutrophils increased from 11 to 17 % ; P < .05 ) .
CONCLUSIONS	Feeding horses with RAO and IAD a PUFA supplement containing 1.5-3 g DHA for 2 months provides an additional benefit to low-dust diet .

###26304663
BACKGROUND	Patients with severe left ventricular dysfunction , ischemic heart failure , and coronary artery disease suitable for coronary artery bypass grafting ( CABG ) are at higher risk for surgical morbidity and mortality .
BACKGROUND	Paradoxically , those patients with the most severe coronary artery disease and ventricular dysfunction who derive the greatest clinical benefit from CABG are also at the greatest operative risk , which makes decision making regarding whether to proceed to surgery difficult in such patients .
BACKGROUND	To better inform such decision making , we analyzed the Surgical Treatment for Ischemic Heart Failure ( STICH ) CABG population for detailed information on perioperative risk and outcomes .
RESULTS	In both STICH trials ( hypotheses ) , 2136 patients with a left ventricular ejection fraction of 35 % and coronary artery disease were allocated to medical therapy , CABG plus medical therapy , or CABG with surgical ventricular reconstruction .
RESULTS	Relationships of baseline characteristics and operative conduct with morbidity and mortality at 30 days were evaluated .
RESULTS	There were a total of 1460 patients randomized to and receiving surgery , and 346 ( 25 % ) of these high-risk patients developed a severe complication within 30 days .
RESULTS	Worsening renal insufficiency , cardiac arrest with cardiopulmonary resuscitation , and ventricular arrhythmias were the most frequent complications and those most commonly associated with death .
RESULTS	Mortality at 30 days was 5.1 % and was generally preceded by a serious complication ( 65 of 74 deaths ) .
RESULTS	Left ventricular size , renal dysfunction , advanced age , and atrial fibrillation/flutter were significant preoperative predictors of mortality within 30 days .
RESULTS	Cardiopulmonary bypass time was the only independent surgical variable predictive of 30-day mortality .
CONCLUSIONS	CABG can be performed with relatively low 30-day mortality in patients with left ventricular dysfunction .
CONCLUSIONS	Serious postoperative complications occurred in nearly 1 in 4 patients and were associated with mortality .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00023595 .

###25346054
BACKGROUND	We explored sex differences in the neural mechanisms mediating placebo analgesia in an established visceral pain model involving painful rectal distensions in healthy volunteers .
METHODS	N = 15 men and N = 15 women underwent three consecutive functional magnetic resonance imaging sessions during which cued painful rectal distensions were delivered .
METHODS	After an adaptation session , positive expectations were induced with deceptive instructions regarding administration of an analgesic drug ( placebo session ) .
METHODS	In the other session ( control ) , truthful information about an inert substance was given .
METHODS	Sex differences in placebo-induced modulation of neural activation during anticipation and pain were analyzed along with ratings of expected and perceived pain intensity .
RESULTS	Placebo-induced reductions in pain ratings were comparable between men and women .
RESULTS	At the level of the brain , group comparisons with respect to differences between the placebo and control conditions revealed greater modulation of the posterior insula ( regions-of-interest analysis : pFWE < 0.05 ) and dorsolateral prefrontal cortex ( whole-brain analysis : p < 0.001 , uncorrected ) during pain anticipation in women .
RESULTS	During pain , placebo-induced down-regulation of the insula was altered in women compared to men ( ROI analysis : pFWE < 0.05 ) .
CONCLUSIONS	Our data provide first evidence supporting sex differences in pain-induced neural modulation during visceral placebo analgesia despite similar placebo-induced reductions in perceived pain intensity .
CONCLUSIONS	These preliminary findings might contribute to elucidating mechanisms mediating placebo effects in clinical conditions associated with chronic abdominal pain such as in irritable bowel syndrome .

###24401143
BACKGROUND	Task-specific locomotor training has been promoted to improve walking-related outcome after incomplete spinal cord injury ( iSCI ) .
BACKGROUND	However , there is also evidence that lower extremity strength training might lead to such improvements .
BACKGROUND	The aim of this randomized cross-over pilot study was to compare changes in a broad spectrum of walking-related outcome measures and pain between robot-assisted gait training ( RAGT ) and strength training in patients with chronic iSCI , who depended on walking assistance .
BACKGROUND	We hypothesized that task-specific locomotor training would result in better improvements compared to strength training .
METHODS	Nine participants with a chronic iSCI were randomized to group 1 or 2 .
METHODS	Group 1 received 16 sessions of RAGT ( 45min each ) within 4 weeks followed by 16 sessions of strength training ( 45min each ) within 4 weeks .
METHODS	Group 2 received the same interventions in reversed order .
METHODS	Main outcome measures were the 10m Walk Test ( 10MWT ) at preferred and maximal speed .
METHODS	Furthermore , we assessed several measures such as walking speed under different conditions , balance , strength , and 2 questionnaires that evaluate risk of falling and pain .
METHODS	Data were collected at baseline , between interventions after 4 weeks , directly after the interventions and at follow-up 6 months after the interventions .
METHODS	Pain was assessed repeatedly throughout the study .
RESULTS	There were no significant differences in changes in scores between the 2 interventions , except for maximal walking speed ( 10MWT ) , which improved significantly more after strength training than after RAGT .
RESULTS	Pain reduced after both interventions .
CONCLUSIONS	In patients with chronic iSCI dependent on walking assistance , RAGT was not more effective in improving walking-related outcome compared to lower extremity strength training .
CONCLUSIONS	However , the low sample size limits generalizability and precision of data interpretation .
BACKGROUND	This study was registered at Clinicaltrials.gov ( NCT01087918 ) .

###25672194
BACKGROUND	Dental caries is the most prevalent communicable disease in the world amongst the population of the children .
OBJECTIVE	To compare the outcome of restorations in primary molars using two Glass ionomer cements Ketac-Molar , a Glass ionomer cement ( GIC ) and Vitremer , a Resin modified glass ionomer cement ( RMGIC ) in small and medium sized cavities .
METHODS	A randomized controlled trial was conducted on 27 children between ages 4-9 years who had bilateral matched pair of carious lesions in primary posterior teeth .
METHODS	A split mouth design was used in which two materials , Ketac Molar and Vitremer , were placed on contralateral sides of the oral cavity in the same patient .
METHODS	The aim was to compare clinical performance of these restorations after 6 months using United States Public Health Service ( USPHS ) criteria .
METHODS	Data were collected six months after restoration using USPHS criteria .
METHODS	Statistical analysis was conducted using SPSS-16 .
METHODS	Categorical variables were described as frequencies , and percentages .
METHODS	Chi-square test was used to compare the frequencies between groups keeping statistical significance at p < 0.05 .
RESULTS	Based on the USPHS criteria , after six months the results of Ketac Molar and Vitemer were comparable , except for sensitivity where RMGIC performed significantly better ( p = 0.040 ) .
RESULTS	Though not significantly different , GIC performed better in 2/10 variables namely marginal discoloration and surface staining .
RESULTS	RMGIC did better in 4/10 variables namely marginal integrity , retention , secondary caries and sensitivity .
RESULTS	Both cements performed almost equally well in 4/10 variables , i.e. , colour match , anatomic form , surface texture and proximal contact .
CONCLUSIONS	Overall the clinical performance of Vitremer was better than Ketac molar and is to be considered as a preferable material for restoration of primary molars .
CONCLUSIONS	More studies are recommended to confirm the results of the present study .

###24520671
OBJECTIVE	To compare the incidence rates of postoperative urinary incontinence between transurethral bipolar plasmakinetic enucleation and resection of the prostate ( PKERP ) and transurethral bipolar plasmakinetic resection of the prostate ( PKRP ) , and provide evidence for the clinical application of PKERP .
METHODS	Totally , 180 BPH patients were equally and randomly assigned to undergo PKERP and PKRP , respectively .
METHODS	We measured the urinary incontinence of the patients by pad test at 24 hours after extubation and every week after surgery for 4 weeks .
METHODS	Meanwhile , we recorded and compared the PSA level , prostate volume , Qmax , residual urine , IPSS , QOL , and the results of pad test between the two groups before and after surgery .
RESULTS	The incidence rates of urinary incontinence in the PKERP and PKRP groups were 35.56 % and 18.89 % ( P < 0.01 ) at 24 hours after extubation , 20.00 % and 7.78 % at 1 week after surgery ( P < 0.05 ) , and 3.33 % and 2.22 % at 2 weeks .
RESULTS	There was no significant difference in the severity of urinary incontinence between the two groups at any time point ( P > 0.05 ) .
RESULTS	No permanent urinary incontinence was observed in either group .
CONCLUSIONS	Compared with PKRP , PKERP has a higher incidence rate of short-term urinary incontinence in the treatment of BPH , but not that of genuine incontinence , with similar severity and recovery time .

###25831645
OBJECTIVE	To investigate the relationship between Vitamin D deficiency and acute otitis media infection .
METHODS	The randomised , single-blind , case-control study was conducted at the Paediatric Department of Ataturk University , Erzurum , Turkey , from January to April 2010 .
METHODS	It comprised ambulatory children diagnosed with acute otitis media and healthy controls .
METHODS	The subjects were divided into groups according to their serum 25-hydroxy vitamin D levels .
METHODS	SPSS 18 was used for statistical analysis .
RESULTS	Of the 169 subjects in the study , 88 ( 52 % ) were the cases and 81 ( 48 % ) were controls .
RESULTS	The mean age of the cases was 6.213.4 years , and 6.183.12 years for the controls ( p < 0.951 ) .
RESULTS	Serum 25-hydroxy vitamin D levels in the cases and controls were 20.610.2 ng/mL and 23.810.3 ng/mL ( p < 0.05 ) .
RESULTS	There was no statistically significant difference between the groups in terms of parathormone and calcium levels ( p > 0.05 ) .
CONCLUSIONS	Serum 25-hydroxy vitamin D levels being significantly lower in children diagnosed with acute otitis media compared to the controls in two otherwise similar groups suggests that Vitamin D deficiency plays a role in otitis media infection .

###25593120
BACKGROUND	Chronic kidney disease ( CKD ) is strongly related to outcome in cardiovascular diseases .
BACKGROUND	The relationship between treatment of mitral regurgitation ( MR ) and renal function is not well described .
BACKGROUND	We sought to evaluate renal function before and after mitral valve repair by the MitraClip device .
RESULTS	Patients with moderate-to-severe or severe ( 3 + or 4 + , respectively ) MR by core laboratory determination who underwent transcatheter mitral valve repair with the MitraClip device in multicenter , investigational trials were included in this study .
RESULTS	Estimated glomerular filtration rate ( eGFR ) was evaluated before and at hospital discharge , 30 days , 6 months , and 1 year after mitral valve repair .
RESULTS	Eight hundred fifty-four patients with baseline mean eGFR 61.5 23.1 mL/min/1 .73 m ( 2 ) were studied , including 438 ( 51.3 % ) with eGFR 60 mL/min/1 .73 m ( 2 ) ( CKD stage 1 or 2 ) , 371 ( 42.6 % ) with eGFR 30 to 59 mL/min/1 .73 m ( 2 ) ( CKD stage 3 ) , and 52 ( 6.1 % ) with eGFR < 30 mL/min/1 .73 m ( 2 ) ( CKD stage 4 or 5 ) .
RESULTS	Baseline renal dysfunction was more prevalent in older patients with a history of heart failure , coronary artery disease , cerebrovascular disease , diabetes mellitus , hypertension , and atrial fibrillation .
RESULTS	Baseline eGFR was associated with 1-year survival ( P < 0.001 ) after MitraClip repair .
RESULTS	At 1-year follow-up , the mean change in eGFR for the overall cohort was -1.0 15.1 mL/min/1 .73 m ( 2 ) ; for patients with CKD stage 1 or 2 , stage 3 , or stage 4 or 5 , mean change was -4.1 16.6 , +2.6 12.4 , and +4.8 9.5 mL/min/1 .73 m ( 2 ) , respectively .
RESULTS	Linear mixed effect modeling demonstrated a strong association between MR and eGFR , and a statistically significant improvement in eGFR in patients with CKD stage 4 or 5 associated with MR reduction to 2 + ( P = 0.007 ) .
CONCLUSIONS	Renal dysfunction is associated with lower survival in patients with severe MR even after percutaneous mitral valve repair .
CONCLUSIONS	Reduction in MR severity by the MitraClip device is associated with improvement in renal function at 1 year in patients with baseline renal dysfunction .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifiers : NCT00209274 , NCT01931956 , NCT01940120 .

###25129531
BACKGROUND	Bipolar Disorder ( BD ) is a severe mental health problem .
BACKGROUND	Psychological interventions are recommended by the National Institute for Health and Care Excellence ( NICE ) but patients experience severe inequalities in access .
BACKGROUND	This study assessed the feasibility and potential effectiveness of a recovery informed web-based self-management intervention for people with BD .
METHODS	An online randomised controlled trial ( n = 122 ) compared treatment as usual ( TAU ) plus the ` Living with Bipolar ' ( LWB ) intervention with a waiting list control ( WLC ) group .
RESULTS	The study recruited to target and the retention rates were high .
RESULTS	Participants engaged with the approach .
RESULTS	Compared with the WLC , those receiving LWB showed the most robust improvement in psychological and physical domains of quality of life , wellbeing and recovery at the end of the intervention .
CONCLUSIONS	The trial was not definitive and requires further investigation .
CONCLUSIONS	There is preliminary evidence that a web-based treatment approach in BD is feasible and potentially effective .
CONCLUSIONS	Such interventions could form part of the Improving Access to Psychological Therapy ( IAPT ) initiative in severe mental health .

###25646872
OBJECTIVE	Trauma exposure predicts mental disorders , medical morbidity , and health care costs .
OBJECTIVE	Yet trauma-related impacts have not received sufficient attention in primary care provider ( PCP ) training programs .
OBJECTIVE	This study adapted a theory-based approach to working with trauma survivors , Risking Connection , into a 6-hour CME course , Trauma-Informed Medical Care ( TI-Med ) , and evaluated its efficacy .
METHODS	We randomized PCPs to training or wait-list ( delay ) conditions ; wait-list groups were trained after reassessment .
METHODS	The primary outcome assessing newly acquired skills was a patient-centeredness score derived from Roter Interactional Analysis System ratings of 90 taped visits between PCPs and standardized patients ( SPs ) .
METHODS	PCPs were family medicine residents ( n = 17 ) and community physicians ( n = 13 , 83 % family medicine specialty ) , from four sites in the Washington , DC metropolitan area .
RESULTS	Immediately trained PCPs trended toward a larger increase in patient centeredness than did the delayed PCPs , with a moderate effect size ( .66 ) .
RESULTS	The combined trained PCP groups showed a significant increase in patient centeredness from before to after training .
CONCLUSIONS	This is a promising approach to supporting relationship-based trauma-informed care among PCPs to help promote better patient health and higher compliance with medical treatment plans .

###25439206
BACKGROUND	In this study , we compared the effectiveness of laser-aided circumferential supracrestal fiberotomy ( CSF ) and low-level laser therapy ( LLLT ) with conventional CSF in reducing relapse of corrected rotations .
METHODS	The study included 24 patients who were at the finishing stage of orthodontic treatment and had at least 1 maxillary incisor with 30 to 70 of rotation before starting therapy .
METHODS	The subjects were divided into 4 groups by treatment : conventional CSF , Er : YAG laser-aided CSF , LLLT , and control .
METHODS	After alginate impressions were taken , the archwire was sectioned from the experimental incisors , and they were allowed to relapse .
METHODS	The second impression was taken 1month later , and the degree and percentage of relapse were calculated in photographs taken from the dental models .
METHODS	Gingival recession , pocket depth , and pain were also measured in the CSF groups .
RESULTS	The mean percentages of relapse were 9.7 % in the conventional CSF , 12.7 % in the Er : YAG laser-aided CSF , 11.7 % in the LLLT , and 27.8 % in the control groups .
RESULTS	Relapse was significantly greater in the control than the experimental groups ( P < 0.05 ) , which were not statistically different from each other .
RESULTS	The changes in sulcus depth and gingival recession were small and not significantly different among the CSF groups ( P > 0.05 ) , but pain intensity was greater in subjects who underwent conventional CSF ( P = 0.003 ) .
CONCLUSIONS	Er : YAG laser-aided CSF proved to be an effective alternative to conventional CSF in reducing rotational relapse .
CONCLUSIONS	LLLT with excessively high energy density was also as effective as the CSF procedures in alleviating relapse , at least in the short term .

###24286482
OBJECTIVE	The aim of this study was to investigate the difference in subjective cure rate and patient satisfaction between tension-free vaginal tape ( TVT ) and transobturator tape ( TOT ) surgical methods in the treatment of stress and mixed urinary incontinence .
METHODS	From January 2004 to November 2006 , a total of 100 patients suffering from stress or mixed urinary incontinence and evaluated to benefit from operative treatment were randomized to undergo either TVT or TOT surgery in Oulu University Hospital .
METHODS	There were no significant differences between the study groups concerning the patient characteristics .
METHODS	During the 3 , 14 and 46 month follow-up steps , information on subjective cure and patient satisfaction was gathered with Urinary Incontinence Severity Score and Detrusor Instability Score questionnaires and a specific question about satisfaction .
RESULTS	The subjective cure rate was 81 % in both study groups .
RESULTS	The satisfaction rate was 79 % in the TVT group and 74 % in the TOT group at the final follow-up .
RESULTS	Urge symptoms were relieved in 70 % of patients in the mixed urinary incontinence subgroup .
RESULTS	De novo urgency occurred in 17 % of the patients in the stress urinary incontinence subgroup , and 45 % of these patients were unsatisfied after the follow-up .
CONCLUSIONS	TVT and TOT are equally effective methods in the treatment of urinary incontinence and patient satisfaction is similar in both methods .
CONCLUSIONS	A large proportion of patients with mixed urinary incontinence found the operation beneficial for urge symptoms .

###25646328
BACKGROUND	A single nucleotide polymorphism ( SNP ) of the patatin-like phospholipase-3 ( PNPLA3 ) / adiponutrin gene ( rs738409 C > G ) is strongly associated with nonalcoholic fatty liver disease ; to our knowledge , no data are available on the impact of this PNPLA3 SNP on liver and metabolic outcomes during pregnancy in patients with gestational diabetes ( GD ) .
OBJECTIVE	We evaluated the impact of the PNPLA3 rs738409 SNP on liver enzymes , metabolic indexes , and maternal and neonatal outcomes in 200 GD patients enrolled in a lifestyle intervention .
METHODS	In a randomized trial with a 2 2 factorial design , exercise significantly improved maternal and neonatal outcomes in GD patients .
METHODS	Effects of the G allele on metabolic and liver indexes and maternal and neonatal outcomes were evaluated in these patients .
RESULTS	At the end of the trial , fasting insulin and homeostasis model assessment of insulin resistance ( HOMA-IR ) values were significantly lower and liver enzymes significantly higher in PNPLA3 G-allele carriers .
RESULTS	In a multiple regression model , the G allele was associated directly with aspartate aminotransferase ( = 2.60 ; 95 % CI : 0.99 , 4.20 ) , alanine aminotransferase ( = 3.70 ; 95 % CI : 1.78 , 5.62 ) , and - glutamyl transferase ( = 3.70 ; 95 % CI : 0.80 , 6.60 ) and inversely with insulin ( = -2.01 ; 95 % CI : -3.24 , -0.78 ) and HOMA-IR ( = -0.39 ; -0.64 , -0.14 ) values at the end of the trial .
RESULTS	In a multiple logistic regression model , the G allele was associated directly with risk of developing liver enzyme elevation during pregnancy ( OR : 4.21 ; 95 % CI : 1.78 , 9.97 ) and inversely with the birth of large-for-gestational-age newborns ( OR : 0.19 ; 95 % CI : 0.06 , 0.62 ) .
RESULTS	No diet genotype or exercise genotype interaction was shown .
CONCLUSIONS	The PNPLA3 SNP rs738409 G allele was associated with risk of mildly elevated transaminases in GD independent of a lifestyle intervention and despite a significant reduction in insulin resistance and risk of macrosomic offspring .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01506310 .

###24268099
BACKGROUND	Day-hospital-based treatment programmes have been recommended for poorly functioning patients with personality disorders ( PD ) .
BACKGROUND	However , more research is needed to confirm the cost-effectiveness of such extensive programmes over other , presumably simpler , treatment formats .
METHODS	This study compared health service costs and psychosocial functioning for PD patients randomly allocated to either a day-hospital-based treatment programme combining individual and group psychotherapy in a step-down format , or outpatient individual psychotherapy at a specialist practice .
METHODS	It included 107 PD patients , 46 % of whom had borderline PD , and 40 % of whom had avoidant PD .
METHODS	Costs included the two treatment conditions and additional primary and secondary in - and outpatient services .
METHODS	Psychosocial functioning was assessed using measures of global ( observer-rated GAF ) and occupational ( self-report ) functioning .
METHODS	Repeated assessments over three years were analysed using mixed models .
RESULTS	The costs of step-down treatment were higher than those of outpatient treatment , but these high costs were compensated by considerably lower costs of other health services .
RESULTS	However , costs and clinical gains depended on the type of PD .
RESULTS	For borderline PD patients , cost-effectiveness did not differ by treatment condition .
RESULTS	Health service costs declined during the trial , and functioning improved to mild impairment levels ( GAF > 60 ) .
RESULTS	For avoidant PD patients , considerable adjuvant health services expanded the outpatient format .
RESULTS	Clinical improvements were nevertheless superior to the step-down condition .
CONCLUSIONS	Our results indicate that decisions on treatment format should differentiate between PD types .
CONCLUSIONS	For borderline PD patients , the costs and gains of step-down and outpatient treatment conditions did not differ .
CONCLUSIONS	For avoidant PD patients , the outpatient format was a better alternative , leaning , however , on costly additional health services in the early phase of treatment .
BACKGROUND	Clinical Trials NCT00378248 .

###24806137
BACKGROUND	Induction of therapeutic hypothermia is often complicated by shivering .
BACKGROUND	Nefopam , a nonsedative benzoxazocine analgesic , reduces the shivering threshold ( triggering core temperature ) with minimal side effects .
BACKGROUND	Consequently , nefopam is an attractive drug for inducing therapeutic hypothermia .
BACKGROUND	However , nefopam alone is insufficient and thus needs to be combined with another drug .
BACKGROUND	Meperidine also reduces the shivering threshold .
BACKGROUND	We therefore determined whether the combination of nefopam and meperidine is additive , infra-additive , or synergistic on the shivering threshold .
METHODS	Ten volunteers were each studied on 4 randomly assigned days .
METHODS	In random order , they were given the following treatments : ( 1 ) control , no drug ; ( 2 ) nefopam to a target concentration of 0.1 g/mL ; ( 3 ) meperidine to a target concentration of 0.1 g/mL ; and ( 4 ) both nefopam and meperidine at target concentrations of 0.1 g/mL each .
METHODS	Lactated Ringer 's solution at 4C was infused to decrease core temperature while mean skin temperature was kept near 30.5 C.
METHODS	The core temperature that increased oxygen consumption > 25 % defined the shivering threshold .
RESULTS	Nefopam reduced the shivering thresholds by 0.7 C 0.3 C compared with no drug .
RESULTS	Meperidine reduced the shivering thresholds by 0.4 C 0.3 C compared with no drug .
RESULTS	When combined , the shivering threshold decreased by only 0.6 C 0.4 C , which was about half what would have been expected based on the individual effects of each drug ( P < 0.001 ) .
RESULTS	The effect of combined nefopam and meperidine on the shivering threshold was thus infra-additive .
CONCLUSIONS	The combination of nefopam and meperidine should be avoided for induction of therapeutic hypothermia .
CONCLUSIONS	Better options would be combinations of drugs that are at least additive or even synergistic .

###24628884
OBJECTIVE	Research on face-to-face treatment for substance misuse suggests that patients ' social networks may impact treatment entry and participation , but there has been no similar research on entry and participation in telephone-based continuing care .
OBJECTIVE	We examined whether alcohol-specific social support predicted engagement and participation in telephone continuing care for alcohol dependence , and whether treatment participation resulted in beneficial changes in participants ' social networks .
METHODS	Participants were 252 adults ( 162 male ) enrolled in a randomized clinical trial testing the effectiveness of telephone continuing care for alcohol dependence .
METHODS	Participants who completed 3 weeks of intensive outpatient treatment were randomly assigned to treatment as usual , telephone monitoring ( TM ; N = 83 ) , or telephone monitoring and brief counseling ( TMC ; N = 83 ) .
METHODS	TM and TMC included 18 months of telephone treatment .
METHODS	Alcohol-specific social support was measured with the Important People Inventory at baseline and 6 , 12 , 18 , and 24-month follow-up .
RESULTS	Alcohol-specific social support did not predict entry into TM or TMC .
RESULTS	Among those who entered telephone treatment ( N = 127 ) , participants with higher network percentage of daily drinkers , higher percentage of network members who accept drinking , and lower percentage of network members who do not accept drinking completed more continuing care calls .
RESULTS	There was no effect of continuing care participation on alcohol-specific social support over 24 months of follow-up .
CONCLUSIONS	Participants with more problematic social networks may self-select additional support in the form of telephone continuing care .
CONCLUSIONS	Telephone continuing care does not appear to result in social network change .

###24722351
BACKGROUND	A serogroup B meningococcal vaccine ( 4CMenB ) has been licensed by the European commission for use in various infant schedules .
BACKGROUND	However , data are limited on persistence of serum bactericidal antibodies ( SBA ) , which is necessary to inform cost-effectiveness analysis .
METHODS	Sera were obtained from 3 groups of 5-year-old children previously immunized at 6 , 8 , 12 and 40 months with either 4CMenB or rMenB ( which lacks the outer membrane vesicle of 4CMenB ) or at 40 and 42 months with 4CMenB only .
METHODS	Forty-nine control children were also recruited and blood obtained before and after 2 doses of 4CMenB at 60 and 62 months of age .
METHODS	Sera were tested for SBA to meningococcal B reference strains .
RESULTS	At 5 years of age , 67 % of those receiving 4CMenB in infancy had SBA titers 1:4 for strain 44/76 , 100 % for 5/99 , 17 % for NZ98/254 and 45 % for M10713 .
RESULTS	Results for rMenB recipients varied from 0 ( NZ98/254 ) to 100 % ( 5/99 ) .
RESULTS	Of those immunized with 4CMenB at 40 and 42 months , 38 % had SBA titers 1:4 at age 5 for 44/76 , 100 % for 5/99 , 0 % ( NZ98/254 ) and 83 % ( M10713 ) .
RESULTS	Among controls , SBA titers were 1:4 in 4 % ( H44/76 , 5/99 ) , 0 % ( NZ98/254 ) and 67 % ( M10713 ) at baseline , increasing to 100 % ( H44/76 and 5/99 ) , 89 % ( NZ98/254 ) and 97 % ( M10713 ) postimmunization .
CONCLUSIONS	The variable rates of waning of antibody to the 4 components of 4CMenB complicates estimates of duration of protection and should be taken into account in cost-effectiveness analyses .
CONCLUSIONS	A 2-dose schedule of 4CMenB in 5-year-old children was immunogenic .

###26084138
OBJECTIVE	To compare the postoperative analgesic efficacy and side effects of paracetamol and tramadol in patients undergoing lumbar disc surgery .
METHODS	Group P ( paracetamol group ) was given 1 g of paracetamol intravenously 30 min before the end of the operation and 1 g each day at 6-h intervals .
METHODS	Group T ( tramadol group ) was given 1.5 mg/kg of tramadol as a loading dose and patient-controlled analgesia for 1 day .
METHODS	Hemodynamic parameters , modified Aldrete score , Ramsay sedation scale score , patient satisfaction scale ( PSS ) score , visual analog scale ( VAS ) score , nausea/vomiting scale score , and additional analgesic needs/times were recorded .
RESULTS	PSS scores were significantly higher in Group T ( P < 0.05 ) .
RESULTS	The total analgesic consumption was significantly higher in Group P.
RESULTS	There were no significant differences in the VAS scores at any time points .
RESULTS	Twenty-one patients in Group P and 8 patients in Group T needed additional analgesia ( P < 0.05 ) .
RESULTS	The first additional analgesic time was earlier in Group P , and pain was more evident at the 15th minute and at hours 2 and 6 ( P < 0.05 ) .
CONCLUSIONS	Paracetamol alone was not able to provide effective analgesia .
CONCLUSIONS	Tramadol was more effective in the treatment of postoperative pain after lumbar disc surgery .

###26091743
BACKGROUND	Unintended pregnancy remains a serious public health challenge in the USA .
BACKGROUND	We assessed the effects of an intervention to increase patients ' access to long-acting reversible contraceptives ( LARCs ) on pregnancy rates .
METHODS	We did a cluster randomised trial in 40 reproductive health clinics across the USA in 2011-13 .20 clinics were randomly assigned to receive evidence-based training on providing counselling and insertion of intrauterine devices ( IUDs ) or progestin implants and 20 to provide standard care .
METHODS	Usual costs for contraception were maintained at all sites .
METHODS	We recruited women aged 18-25 years attending family planning or abortion care visits and not desiring pregnancy in the next 12 months .
METHODS	The primary outcome was selection of an IUD or implant at the clinic visit and secondary outcome was pregnancy within 12 months .
METHODS	We used generalised estimating equations for clustered data to measure the intervention effect on contraceptive selection , and used survival analysis to assess pregnancy rates .
RESULTS	Of 1500 women enrolled , more at intervention than control sites reported receiving counselling on IUDs or implants ( 565 [ 71 % ] of 797 vs 271 [ 39 % ] of 693 , odds ratio 38 , 95 % CI 28-52 ) and more selected LARCs during the clinic visit ( 224 [ 28 % ] vs 117 [ 17 % ] , 19 , 13-28 ) .
RESULTS	The pregnancy rate was lower in intervention group than in the control group after family planning visits ( 79 vs 154 per 100 person-years ) , but not after abortion visits ( 265 vs 223 per 100 person-years ) .
RESULTS	We found a significant intervention effect on pregnancy rates in women attending family planning visits ( hazard ratio 054 , 95 % CI 034-085 ) .
CONCLUSIONS	The pregnancy rate can be reduced by provision of counselling on long-term reversible contraception and access to devices during family planning counselling visits .
BACKGROUND	William and Flora Hewlett Foundation .

###24354863
BACKGROUND	The anti-IgE monoclonal antibody , omalizumab , is approved in the US as add-on therapy for patients 12 years of age with moderate-to-severe persistent allergic asthma .
BACKGROUND	Omalizumab is administered according to the US Food and Drug Administration approved dosing table included in the prescribing information .
BACKGROUND	The dosing table was developed using Genentech 's free IgE assay and is designed to achieve free serum IgE levels of < 50ng/mL , known to be associated with clinical benefit .
BACKGROUND	Lack of clinical benefit in a subset of patients on omalizumab has prompted demand for commercial free IgE assays to guide omalizumab dosing .
BACKGROUND	To date , two commercial free IgE assays marketed by ViraCor-IBT ( no longer offered ) and BioTeZ have been available to physicians .
OBJECTIVE	This study compares the results generated from the two commercial free IgE assays with the free IgE levels generated by the Genentech assay .
METHODS	Two serum sample sets were prepared using 20 samples from patients with a wide range of IgE and omalizumab from an omalizumab clinical trial and 36 samples from omalizumab-nave patients .
METHODS	Different amounts of omalizumab were added to the 36 omalizumab nave samples based on measured total IgE levels to ensure that a good range of IgE and omalizumab was represented in the study samples .
METHODS	Samples were randomized for blinded analysis of free IgE levels using the Genentech , ViraCor-IBT and BioTeZ free serum IgE assays .
METHODS	Analysis of samples in the ViraCor-IBT assay were conducted by ViraCor-IBT and the analysis of samples using the Genentech and BioTeZ assay methods were conducted by a third party contract research organization .
RESULTS	The ViraCor-IBT and BioTeZ free IgE assays demonstrated significantly higher free IgE levels than the Genentech free IgE assay .
RESULTS	Twenty-nine of 56 samples tested < 50ng/mL in the Genentech assay ; of these , 12/29 ( 41 % ) and 20/29 ( 69 % ) tested > 50ng/mL in the BioTeZ and ViraCor-IBT assays , respectively .
RESULTS	In the BioTeZ free IgE evaluations , 11/20 samples that were re-tested had inter-assay differences ranging from 40-190 % .
CONCLUSIONS	Free ligand ( such as IgE ) measurements are challenging and dependent on the method and reagents used .
CONCLUSIONS	The Viracor-IBT and BioTeZ methods tend to over-estimate free serum IgE levels compared with the Genentech free IgE assay .
CONCLUSIONS	Using these assays to monitor therapy and adjust omalizumab doses post treatment is considered off-label use and could lead to a potential risk for unnecessary treatment and/or risk to patient safety .

###25842933
OBJECTIVE	Acute liver failure ( ALF ) usually develops in multiple organ dysfunction syndrome ( MODS ) and carries a high mortality risk in patients after cardiac surgery .
OBJECTIVE	Artificial liver support devices aim to remove albumin-bound and water-soluble toxins arising as a result of liver failure .
OBJECTIVE	The currently most used devices combine haemodialysis with albumin dialysis ( MARS ) or plasma separation and adsorption ( Prometheus ) .
OBJECTIVE	The aim of this study was to assess safety and efficacy of use MARS or Prometheus in elderly patients with ALF have been operated for heart diseases .
METHODS	We studied 26 elder patients with ALF and MODS as postoperative complication after cardiac surgery .
METHODS	Patients were assigned to groups , given a combination of MARS and standard medical therapy ( SMT ) ( MARS-group , n = 9 ) or Prometheus and SMT ( Prometheus-group , n = 17 ) .
METHODS	Inclusion criteria were clinical and laboratory signs of ALF : serum total bilirubin level > 180 mkmol/L , 2-fold increasing serum aspartate aminotransferase ( AST ) and alanine aminotransferase ( ALT ) , low serum cholinesterase and high serum ammonia levels .
METHODS	A variety of clinical and biochemical parameters were assessed .
METHODS	Primary endpoint was survival probabilities at day 28 .
RESULTS	MARS was used to provide 1 to 2 rounds ( minimum of 6 hours each ) and Prometheus was used to provide 2 to 14 rounds ( minimum of 6 hours each ) .
RESULTS	There were amelioration of haemodinamic instability , especially in MARS-group ( increase in ADmean was 17 % in MARS ( p = 0.005 ) and 10 % in Prometheus-group ( p = 0.001 ) ) , increase in P/F ratio ( 12 % in Prometheus-group ( p = 0.07 ) ) , decrease in serum total bilirubin ( 8.6 % in MARS-group ( p = 0.028 ) and 33 % in Prometheus-group ( p < 0.001 ) ) and unconjugated bilirubin levels ( 29 % in Prometheus-group ( p = 0.003 ) ) , also we had decreasing in serum aminotransferase levels and trend to increasing in serum cholinesterase level ( 12 % in MARS-group ( p = 0.87 ) and 8 % in Prometheus-group ( p = 0.86 ) ) .
RESULTS	There were no side effects of extracorporeal liver support in both patients groups .
RESULTS	Survival of patients with ALF , treated with MARS was 22 % , in Prometheus group -- 35 % .
CONCLUSIONS	MARS and Prometheus are found to be safe and effective in patients with ALF after cardiac surgery .
CONCLUSIONS	Further studies are needed to assess whether therapy might be beneficial in specific sublets of patients .

###24531843
OBJECTIVE	To compare the effects of different arm positions on dose exposure and image quality ( IQ ) in cervical spine CT after trauma in different patient groups .
METHODS	Patients in standard ( STD = 126 ) and in swimmer 's position ( SWIM = 254 ) were included .
METHODS	Body mass index ( BMI subgroup 1 = underweight to subgroup 4 = obese ) , anterior-posterior diameter ( AP ) , left-right diameter ( LR ) , area of an ellipse ( AoE ) and angle between the humeral heads ( optimal STD < 3 , optimal SWIM > 10 ) were used as grouping criteria .
METHODS	Computed tomography dose index ( CTDI ) was documented .
METHODS	Two radiologists rated the IQ at three levels ( CV1/2 , CV4/5 , CV7/T1 ) using a semi-quantitative scale ( 0 = not diagnostic , 1 = diagnostic with limitations , 2 = diagnostic without limitations ) .
METHODS	The Mann-Whitney U test correlations of grouping criteria with dose effects and intra-class correlation ( ICC ) were calculated .
RESULTS	ICC was 0.87 .
RESULTS	BMI grouping showed the strongest correlation with dose effects : CTDI of optimal STD versus optimal SWIM positioning was 3.17 mGy versus 2.46 mGy ( subgroup 1 ) , 5.47 mGy versus 3.97 mGy ( subgroup 2 ) , 7.35 mGy versus 5.96 mGy ( subgroup 3 ) and 8.71 mGy versus 8.18 mGy ( subgroup 4 ) .
RESULTS	Mean IQ at CV7/T1 was 1.65 versus 1.23 ( subgroup 1 ) , 1.27 versus 1.46 ( subgroup 2 ) , 1.06 versus 1.46 ( subgroup 3 ) , 0.79 versus 1.5 ( subgroup 4 ) .
CONCLUSIONS	Patients with a BMI > 20 kg/m ( 2 ) benefited from both potential dose reduction and improved image quality at the critical cervicothoracic junction when swimmer 's position was used .
CONCLUSIONS	BMI is a useful metric for personalized optimization in CT for the c-spine .
CONCLUSIONS	Using swimmer 's position , patients can benefit from dose reduction .
CONCLUSIONS	In some patients a superior image quality can be achieved with swimmer 's position .
CONCLUSIONS	For swimmer 's positioning an angle of more than 10 is optimal .

###24273969
OBJECTIVE	To study the mechanism of Dan ' e Fukang Soft Extract ( DFSE ) on improving oocyte and embryo qualities in endometriosis patients undergoing in vitro fertilization-embryo transfer ( IVF-ET ) .
METHODS	Totally 70 patients with endometriosis confirmed by laparoscope were randomly assigned to two groups , the treated group and the control group , 35 cases in each group .
METHODS	Patients in the treated group were treated with DFSE + controlled ovarian hyperstimulation ( COH ) , while those in the control group were treated with DFSE placebo + COH .
METHODS	Besides , recruited were another 35 subjects undergoing intracytoplasmic sperm injection-embryo transfer ( ICSI-ET ) as a normal control group .
METHODS	The content of growth differentiation factor 9 ( GDF-9 ) in the granulocytes of the mature follicular fluid on the oocyte retrieval day was determined by Western blot .
METHODS	The mRNA expression of GDF-9 was detected by RT-PCR .
METHODS	The oocyte retrieval number , the cleavage rate , the fertilization rate , the high-quality embryo rate , and the pregnancy rate were compared .
RESULTS	The mRNA expression of GDF-9 in the granulocytes was significantly higher in the treated group than in the control group , showing statistical difference ( P < 0.05 ) , but with no statistical difference when compared with that of the normal control group .
RESULTS	There was no statistical difference in the cleavage rate between the two groups ( P > 0.05 ) .
RESULTS	The fertilization rate and the high-quality embryo rate were higher in the treated group than in the control group , showing statistical difference ( P < 0.05 ) , but with no statistical difference when compared with that of the normal control group .
CONCLUSIONS	DFSE could improve the oocyte and embryo qualities of endometriosis patients undergoing IVF-ET .
CONCLUSIONS	Its mechanism might be associated with regulating the GDF-9 mRNA level of granulocytes .

###25779750
OBJECTIVE	To study the efficacy/safety of apremilast , an oral phosphodiesterase 4 inhibitor , compared with placebo in patients with active rheumatoid arthritis ( RA ) who had an inadequate response to methotrexate ( MTX ) .
METHODS	Patients were randomized 1:1:1 to receive placebo , apremilast 20 mg twice a day , or apremilast 30 mg twice a day .
METHODS	Patients whose swollen and tender joint counts had not improved by 20 % were considered nonresponders at week 16 and were required to enter the protocol-defined early escape .
METHODS	At week 24 , patients were transitioned in a blinded manner to receive apremilast 20 mg twice a day if they were initially randomized to receive placebo .
METHODS	Patients who were not initially randomized to receive placebo continued to receive their target apremilast dose .
METHODS	Patients were required to take a stable dose of MTX ( 7.5-25 mg/week ) throughout the study .
METHODS	Magnetic resonance imaging ( MRI ) was performed in a subset of patients .
RESULTS	A total of 237 patients who were receiving MTX therapy were randomized and received 1 dose of study medication .
RESULTS	At week 16 , similar proportions of patients receiving placebo ( 35 % ) , apremilast 20 mg twice a day ( 28 % ) , and apremilast 30 mg twice a day ( 34 % ) met the American College of Rheumatology criteria for 20 % improvement in disease activity ( the primary efficacy end point ) .
RESULTS	In the MRI substudy , mean change from baseline in total joint damage scores according to the Rheumatoid Arthritis Magnetic Resonance Imaging Scoring system was generally similar with either apremilast dose at week 16 .
RESULTS	At week 52 , no trends were noted for clinical end points by treatment group .
RESULTS	Both apremilast doses were generally well tolerated .
CONCLUSIONS	Apremilast efficacy was not demonstrated in patients who had active RA despite stable MTX therapy .

###25636332
BACKGROUND	Each year , approximately 11 % of women diagnosed with breast cancer in the United States are 45 years of age or younger .
BACKGROUND	These women have concerns specific to or accentuated by their age , including fertility-related concerns , and have higher rates of psychosocial distress than women diagnosed at older ages .
BACKGROUND	Current guidelines recommend that fertility risks be considered early in all treatment plans ; however , the extant research indicates that attention to fertility by the healthcare team is limited .
BACKGROUND	Importantly , attention to fertility may be a proxy for whether or not other important issues warranting attention in younger women with breast cancer are addressed , including genetic risks , psychosocial distress , sexual functioning , and body image concerns .
BACKGROUND	The Young & Strong study tests the efficacy of an intervention designed for young women recently diagnosed with breast cancer and their oncologists with the intention to : 1 ) increase attention to fertility as an important surrogate for other issues facing young women , 2 ) educate and support young women and their providers , and 3 ) reduce psychosocial distress among young women with breast cancer .
METHODS	The study employs a cluster randomized design including 14 academic institutions and 40 community sites across the U.S. assigned to either the study intervention arm or contact-time comparison intervention arm .
METHODS	Academic institutions enroll up to 15 patients per site while community sites enroll up to 10 patients .
METHODS	Patient eligibility requirements include : an initial diagnosis of stage I-III invasive breast cancer within three months prior , without a known recurrence or metastatic breast cancer ; 18-45 years of age at diagnosis ; ability to read and write in English .
METHODS	The primary outcome is oncologists ' attention to fertility concerns as determined by medical record review .
METHODS	Secondary outcomes include differences in patient satisfaction with care and psychosocial distress between the two study arms .
CONCLUSIONS	Study findings will provide valuable insight into how to increase attention to fertility and other issues specific to young women with breast cancer and how to improve doctor-patient communication around these issues , which may promote better quality of care for this population .
BACKGROUND	NCT01647607 .
BACKGROUND	Registered July 19 , 2012 .

###24640666
OBJECTIVE	To evaluate the clinical efficiency , tolerance , and pharmacoeconomic parameters of treatment for mild community-acquired pneumonia ( CAP ) in patients with risk factors for ineffective treatment with levofloxacin ( Glevo ) versus original levofloxacin and standard pharmacotherapy regimens for mild pneumonia ( real practice ) .
METHODS	An open-label comparative randomized trial was conducted in parallel groups of 147 patients aged > or = 18 years with mild CAP and risk factors for ineffective treatment .
METHODS	Group 1 included 61 patients ( 59 men and 2 women ; mean age 23.3 + / - 11.2 years ) receiving levofloxacin ( Glevo ) 500 mg/day ; Group 2 comprised 41 patients ( 39 men and 1 woman ; mean age 26.4 + / - 13.4 years ) treated with original levofloxacin 500 mg/day ; Group 3 consisted of 45 patients ( all men ; mean age 23.7 + / - 9.9 years ) on standard therapy .
METHODS	The trial was performed in 3 pulmonology centers .
RESULTS	The use of the respiratory fluoroquinolone levofloxacinto treat mild CAP in the patients with risk factors for failure for its therapy demonstrated a higher efficiency than the antibiotic regimens used in real clinical practice .
RESULTS	This suggests that physicians underestimate risk factors and do not always make a rational choice of an antimicrobial agent in the given clinical situation .
CONCLUSIONS	The generic form of levofloxacin ( Glevo ) is as clinically effective as its original drug in the treatment of CAP and characterized by its optimal pharmacoeconomic parameters .

###25393645
BACKGROUND	Abaloparatide is a novel synthetic peptide analog of parathyroid hormone-related protein ( PTHrP ) that is currently being developed as a potential anabolic agent in the treatment of postmenopausal osteoporosis .
OBJECTIVE	This study sought to assess the effects of abaloparatide on bone mineral density ( BMD ) at the lumbar spine , total hip , and femoral neck in postmenopausal women with osteoporosis .
METHODS	Multi-center , multi-national , double-blind placebo controlled trial in which postmenopausal women were randomly assigned to receive 24 weeks of treatment with daily sc injections of placebo , abaloparatide , 20 , 40 , or 80 g , or teriparatide , 20 g.
METHODS	A 24-week extension was also performed in a subset of subjects .
METHODS	Postmenopausal women with osteoporosis ( n = 222 ) .
METHODS	BMD by dual-x-ray absorptiometry and biochemical markers of bone turnover .
RESULTS	At 24 weeks , lumbar spine BMD increased by 2.9 , 5.2 , and 6.7 % in the abaloparatide , 20 - , 40 - , and 80-g groups , respectively , and 5.5 % in the teriparatide group .
RESULTS	The increases in the 40 - and 80-g abaloparatide groups and the teriparatide group were significantly greater than placebo ( 1.6 % ) .
RESULTS	Femoral neck BMD increased by 2.7 , 2.2 , and 3.1 % in abaloparatide , 20 - , 40 - , and 80-g groups , respectively , and 1.1 % in the teriparatide group .
RESULTS	The increase in femoral neck BMD with abaloparatide , 80 g was significantly greater than placebo ( 0.8 % ) .
RESULTS	Total hip BMD increased by 1.4 , 2.0 , and 2.6 % in the abaloparatide , 20 - , 40 - , and 80-g groups , respectively .
RESULTS	The total hip increases in the 40 - and 80-g abaloparatide groups were greater than both placebo ( 0.4 % ) and teriparatide ( 0.5 % ) .
CONCLUSIONS	Compared with placebo , 24 weeks of daily sc abaloparatide increases BMD of the lumbar spine , femoral neck , and total hip in a dose-dependent fashion .
CONCLUSIONS	Moreover , the abaloparatide-induced BMD increases at the total hip are greater than with the marketed dose of teriparatide .
CONCLUSIONS	These results support the further investigation of abaloparatide as an anabolic therapy in postmenopausal osteoporosis .

###26480555
OBJECTIVE	To observe the clinical effects of myopia in children treated with abdominal acupuncture .
METHODS	Ninety children with myopia were randomly divided into an abdominal acupuncture group ( 45 cases with 90 ill eyes ) and an auricular point group ( 45 cases with 90 ill eyes ) .
METHODS	In the abdominal acupuncture group , Zhongwan ( CV 12 ) , Shangqu ( KI 17 ) , Xiawan ( CV 10 ) , Tianshu ( ST 25 ) , Qihai ( CV 6 ) , Guanyuan ( CV 4 ) were treated with tapping method .
METHODS	The needles were not retained and down to the lower in accordance with the order from Zhongwan ( CV 12 ) to Guanyuan ( CV 4 ) for 5 min , and the erubescence skin without blood was proper .
METHODS	In the auricular point group , vaccaria seeds were pasted at gan ( CO12 ) , shen ( CO10 ) , pi ( CO13 ) , wei ( CO4 ) , yan ( LO5 ) , pingjianqian ( TG2i ) , pingjianhou ( ATli ) and zhen ( AT3 ) ; one ear was chosen every time and the other ear the second time with pressing of patient 's own for 5 min every day .
METHODS	The treatment was given twice a week and 10 treatments were considered as one course in the two groups .
METHODS	The changes of the visual levels in visual chart before treatment , 20 min after the first treatment , after 5 weeks ' and 3 months ' treatment were compared between the two groups , and the clinicall efficacy was compared between the two groups as well .
RESULTS	( 1 ) The visual levels in visual chart were improved in the abdominal acupuncture group and auricular point group , and the effects 20 min after the first treatment , after 5 weeks ' and 3 months ' treatment in the abdominal acupuncture group were superior to those in the auricular point group ( 4.780.16 vs 4.690.22 , P < 0.01 ; 4.850.16 vs 4.790.21 , P < 0.05 ; 4.890.13 vs 4.710.25 , P < 0.01 ) .
RESULTS	( 2 ) The effective rates 20 min after the first treatment , after 5 weeks ' and 3 months ' treatment in the abdominal acupuncture group were better than those in the auricular point group [ 31.4 % ( 27/86 ) vs 0 % ( 0/82 ) .
RESULTS	81.4 % ( 70/86 ) vs 60.0 % ( 49/82 ) ; 88.4 % ( 76/86 ) vs 51.2 % ( 42/82 ) , all P < 0.01 ] .
CONCLUSIONS	Abdominal acupuncture for improving the visual levels of myopia in children is superior to auricular point sticking .

###25391867
OBJECTIVE	To assess the impact of low concentration contrast media on the degree of vascular enhancement , image quality and radiation dose in coronary CT angiography ( cCTA ) studies when using a combination of iterative reconstruction and low tube voltage .
METHODS	120 patients who underwent cCTA were randomly divided into two groups .
METHODS	The patients in group A received iopromide 370 were scanned using the conventional tube output , and images were reconstructed using filtered back projection ( FBP ) .
METHODS	The patients in group B received iodixanol 270 were scanned using the low tube output , and images were reconstructed using iterative reconstruction technique ( SAFIRE , Siemens Healthcare ) .
METHODS	CT attenuation was measured in the coronary arteries , great arteries , interventricular septum and left ventricular cavity .
METHODS	Noise , subjective image quality scores and effective radiation dose were compared between the two groups .
RESULTS	There was no significant difference in the mean CT attenuation achieved , image noise and mean image quality score at each anatomic site between iomeprol 270 group and iopromide 370 group .
RESULTS	The effective radiation dose were 0.44 0.25 mSv and 0.94 0.42 mSv for iomeprol 270 and iopromide 370 in low weight subgroups , and 1.17 0.30 mSv and 2.37 0.66 mSv in high weight subgroups , respectively , reflecting dose savings of 53.2 % ( P < 0.01 ) and 50.6 % ( P < 0.01 ) , respectively .
CONCLUSIONS	The results demonstrate that with a combination of iterative reconstruction and a low tube voltage , a low iodine concentration of 270 mgI/ml still improves the contrast enhancement without impairing image quality , as well as significantly lowers effective radiation dose .

###24480945
METHODS	A prospective , randomized , and controlled clinical trial .
OBJECTIVE	To compare surgical zipper with subcuticular Monocryl sutures in terms of incision closure time , cosmetic results , and the complication rate in patients with adolescent idiopathic scoliosis ( AIS ) undergoing posterior spinal fusion ( PSF ) surgery .
BACKGROUND	In previous literatures , the application of surgical zipper to incision closure has been reported to be associated with a favorable outcome .
BACKGROUND	However , in the PSF surgery of patients with AIS , the use of surgical zipper has not been described .
METHODS	Ninety female patients with AIS undergoing PSF were assigned randomly to 2 incision closure groups either using surgical zipper or using the 4-0 absorbable subcuticular suture .
METHODS	The incision outcome was evaluated with the Hollander Incision Evaluation Score at 7 days , 2 weeks , 6 months , and 1 year after surgery , respectively .
METHODS	Besides , a visual analogue scale was allocated to each patient to rate the cosmetic result of the incision .
METHODS	The 2 groups were compared to determine the differences in terms of incision closure time , the complication rate , and cosmetic results .
RESULTS	The incision closure using surgical zipper consumed significantly less time than that using subcuticular suture ( 45.3 vs. 540.5 s , P < 0.001 ) .
RESULTS	As for the cosmetic results , no significant differences of Hollander Incision Evaluation Score scores between the 2 suturing groups were found .
RESULTS	Besides , patients ' satisfaction with cosmetic outcome on a linear visual analogue scale also revealed similar results between the 2 groups .
RESULTS	As for postoperative complications , we found 1 case of mild blister due to allergy to the tape of the dressings and 2 cases of incisional pain in the Monocryl suture group .
CONCLUSIONS	The application of surgical zipper in PSF surgery is a safe and effective method .
CONCLUSIONS	The ease and the speed of application make surgical zipper an attractive option for incision closure in patients with AIS undergoing PSF .
METHODS	4 .

###24942912
BACKGROUND	D-dimer is related to adverse outcomes in arterial and venous thromboembolic diseases .
OBJECTIVE	To evaluate the predictive value of D-dimer level for stroke , other cardiovascular events , and bleeds , in patients with atrial fibrillation ( AF ) treated with oral anticoagulation with apixaban or warfarin ; and to evaluate the relationship between the D-dimer levels at baseline and the treatment effect of apixaban vs. warfarin .
METHODS	In the ARISTOTLE trial , 18201 patients with AF were randomized to apixaban or warfarin .
METHODS	D-dimer was analyzed in 14878 patients at randomization .
METHODS	The cohort was separated into two groups ; not receiving vitaminK antagonist ( VKA ) treatment and receiving VKA treatment at randomization .
RESULTS	Higher D-dimer levels were associated with increased frequencies of stroke or systemic embolism ( hazard ratio [ HR ] [ Q4 vs. Q1 ] 1.72 , 95 % confidence interval [ CI ] 1.14-2 .59 , P = 0.003 ) , death ( HR [ Q4 vs. Q1 ] 4.04 , 95 % CI3.06-5 .33 ) and major bleeding ( HR [ Q4 vs. Q1 ] 2.47 , 95 % CI1.77-3 .45 , P < 0.0001 ) in the no-VKA group .
RESULTS	Similar results were obtained in the on-VKA group .
RESULTS	Adding D-dimer level to the CHADS2 score improved the C-index from 0.646 to 0.655 for stroke or systemic embolism , and from 0.598 to 0.662 for death , in the no-VKA group .
RESULTS	D-dimer level improved the HAS-BLED score for prediction of major bleeds , with an increase in the C-index from 0.610 to 0.641 .
RESULTS	There were no significant interactions between efficacy and safety of study treatment and D-dimer level .
CONCLUSIONS	In anticoagulated patients with AF , the level of D-dimer is related to the risk of stroke , death , and bleeding , and adds to the predictive value of clinical risk scores .
CONCLUSIONS	The benefits of apixaban were consistent , regardless of the baseline D-dimer level .

###24953021
OBJECTIVE	Rebleeding after an initial oesophageal variceal haemorrhage remains a significant problem despite therapy with band ligation , non-selective - blockers or a combination of these .
OBJECTIVE	Carvedilol is a vasodilating non-selective - blocker with alpha-1 receptor and calcium channel antagonism .
OBJECTIVE	A recent study has suggested it is effective in the prevention of a first variceal bleed .
OBJECTIVE	Our aim was to compare oral carvedilol with variceal band ligation ( VBL ) in the prevention of rebleeding following a first variceal bleed .
METHODS	Patients who were stable 5 days after presentation with a first oesophageal variceal haemorrhage and had not been taking - blockers were randomised to oral carvedilol or VBL .
METHODS	Patients were followed-up after one week , monthly , then every 3 months .
METHODS	The primary end point was variceal rebleeding on intention-to-treat analysis .
RESULTS	64 patients were randomised , 33 to carvedilol and 31 to VBL .
RESULTS	58 ( 90.6 % ) patients had alcohol related liver disease .
RESULTS	Age and Child-Pugh score were similar in both groups at baseline .
RESULTS	Median follow-up was 26.3 ( interquartile range [ IQR ] 10.2-46 .6 ) months .
RESULTS	Compliance was 68 % and 65 % for carvedilol and VBL respectively ( p = 0.993 ) and serious adverse events between the two groups were similar ( p = 0.968 ) .
RESULTS	Variceal rebleeding occurred during follow-up in 12 ( 36.4 % ) and 11 ( 35.5 % ) patients in the carvedilol and VBL groups , respectively ( p = 0.857 ) , with 9 ( 27.3 % ) and 16 ( 51.6 % ) deaths in each group , respectively ( p = 0.110 ) .
CONCLUSIONS	Carvedilol is not superior to VBL in the prevention of variceal rebleeding .
CONCLUSIONS	The trend to a survival benefit for patients taking this drug compared with those undergoing banding requires further exploration .

###24456668
BACKGROUND	Alcohol is responsible for a large and growing proportion of the global burden of disease , as well as being the cause of social problems .
BACKGROUND	Brief interventions are one component of comprehensive policy measures necessary to reduce these harms .
BACKGROUND	Brief interventions increasingly take advantage of the Internet to reach large numbers of high risk groups such as students .
BACKGROUND	The research literature on the efficacy and effectiveness of online interventions is developing rapidly .
BACKGROUND	Although many studies show benefits in the form of reduced consumption , other intervention studies show no effects , for reasons that are unclear .
BACKGROUND	Sweden became the first country in the world to implement a national system in which all university students are offered a brief online intervention via an e-mail .
METHODS	This randomized controlled trial ( RCT ) aims to evaluate the effectiveness of this national system comprising a brief online intervention among university students who are hazardous and harmful drinkers .
METHODS	This study employs a conventional RCT design in which screening to determine eligibility precedes random allocation to immediate or delayed access to online intervention .
METHODS	The online intervention evaluated comprises three main components ; assessment , normative feedback and advice on reducing drinking .
METHODS	Screening is confined to a single question in order to minimise assessment reactivity and to prevent contamination .
METHODS	Outcomes will be evaluated after 2 months , with total weekly alcohol consumption being the primary outcome measure .
METHODS	Invitations to participate are provided by e-mail to approximately 55,000 students in 9 Swedish universities .
CONCLUSIONS	This RCT evaluates routine service provision in Swedish universities via a delay in offer of intervention to the control group .
CONCLUSIONS	It evaluates effects in the key population for whom this intervention has been designed .
CONCLUSIONS	Study findings will inform the further development of the national service provision .
BACKGROUND	ISRCTN02335307 .

###25544263
OBJECTIVE	To determine whether the new selective binding agent sugammadex causes less postoperative nausea and vomiting ( PONV ) than the cholinesterase inhibitor neostigmine .
METHODS	Prospective , randomized , double-blinded study .
METHODS	University-affiliated hospital .
METHODS	One hundred American Society of Anesthesiologists physical status 1 and 2 patients scheduled for extremity surgery .
METHODS	Patients were randomly assigned to neostigmine ( 70 g/kg ) and atropine ( 0.4 mg per mg neostigmine ) or sugammadex 2 mg/kg for neuromuscular antagonism at the end of anesthesia , when 4 twitches in response to train-of-four stimulation were visible with fade .
METHODS	We recorded PONV , recovery parameters , antiemetic consumption , and side effects .
RESULTS	Nausea and vomiting scores were lower in the sugammadex patients upon arrival in the postanesthesia care unit ( med : 0 [ min-max , 0-3 ] vs med : 0 [ min-max , 0-3 ] ; P < .05 ) , but thereafter low and comparable .
RESULTS	Postoperative antiemetic and analgesic consumption were similar in each group .
RESULTS	Extubation ( median [ interquartile range ] , 3 [ 1-3 .25 ] vs 4 [ 1-3 .25 ] ; P < .001 ) first eye opening ( 4 [ 3-7 .25 ] vs 7 [ 5-11 ] ; P < .001 ) , and head lift ( 4 [ 2-7 .25 ] vs 8 [ 11-25 ] ; P < .001 ) in minutes were shorter in patients given sugammadex .
RESULTS	Postoperative heart rates were significantly lower in all measured times patients given neostigmine .
CONCLUSIONS	Nondepolarizing neuromuscular blocking antagonism with sugammadex speeds recovery of neuromuscular strength but only slightly and transiently reduces PONV compared with neostigmine and atropine .

###25277305
CONCLUSIONS	Intravitreal high dose ( 2 mg ) ranibizumab may lead to quicker resolution of choroidal neovascularization ( CNV ) and associated retinal pigment epithelial detachment in eyes with exudative age-related macular degeneration , although it may possibly correlate with RPE tears in certain cases .
OBJECTIVE	This prospective study compared the outcomes of 0.5 vs 2.0 mg intravitreal ranibizumab injections ( RI ) for treating vascularized pigment epithelial detachment ( vPED ) due to age-related macular degeneration .
METHODS	Patients with vPED were randomized to receive 2.0 vs 0.5 mg RI monthly for 12 months or for 4 months and then repeated on a pro-re nata basis .
METHODS	Optical coherence tomography , fundus photography , and fluorescein and indocyanine-green angiography were obtained at baseline and subsequent specific intervals .
METHODS	Outcome measures were best-corrected standardized visual acuities , central 1-mm thickness , surface area ( SA ) , greatest linear diameter ( GLD ) , heights ( PED and CNV ) , and amount of subretinal fluid ( SRF ) and cystoid macular edema ( CME ) .
RESULTS	Both groups yielded reductions of the central 1-mm thickness , PED and CNV SA and PED height and GLD , SRF , and CME .
RESULTS	Vision improvement and reduction in SRF and PED height occurred earlier for eyes receiving the 2.0 mg dose .
RESULTS	Cataract progression was similar but RPE tears developed more often with the 2.0 mg dose .
CONCLUSIONS	There were similar visual and anatomical outcomes at the end of the study ; however , the higher dose yielded more rapid reductions and more complete resolution of the PED , although there was possible increased tendency for an RPE tear with the higher dose .

###24894685
OBJECTIVE	Acute kidney injury ( AKI ) is associated with increased mortality .
OBJECTIVE	While angiotensin-converting enzyme inhibitors ( ACEI ) are known to slow progression of chronic kidney disease , their role in AKI remains unclear .
METHODS	The Randomised Evaluation of Normal vs. Augmented Level Replacement Therapy ( RENAL ) study data were analysed according to ACEI use over time .
METHODS	The primary outcome was all-cause mortality at 90 days following randomisation .
METHODS	Analyses used a multivariate Cox model adjusted for either baseline or for time-dependent covariates , and a sensitivity analysis of patients surviving to at least the median time to ACEI initiation .
RESULTS	Of the 1463 participants with available data on ACE inhibitors usage , 142 ( 9.7 % ) received ACEI at least once during study data collection .
RESULTS	Participants treated with ACEI were older ( P = 0.02 ) and had less sepsis at baseline ( P < 0.001 ) .
RESULTS	ACEI use was significantly associated with lower mortality at 90 days ( HR 0.46 , 95 % CI 0.30-0 .71 , P < 0.001 ) , and an increase in renal replacement therapy-free days ( P < 0.001 ) , intensive care unit-free days ( P < 0.001 ) and hospital free-days ( P < 0.001 ) after adjusting for baseline covariates .
RESULTS	Using the time-dependent analysis , however , the effect of ACEI administration was not significant ( HR 0.78 , 95 % CI 0.51-1 .21 , P = 0.3 ) .
RESULTS	The sensitivity analysis in day 8 survivors produced similar results .
CONCLUSIONS	In the RENAL study cohort , the use of ACEI during the study was not common and , after adjustment for time-dependent covariates , was not significantly associated with reductions in mortality .
CONCLUSIONS	Further assessment of the effect of ACEI use in AKI patients is needed .

###24796045
OBJECTIVE	To observe effects of syndrome-differentiation acupuncture on life quality in patients with functional dyspepsia ( FD ) in order to evaluate its clinical efficacy .
METHODS	One hundred and five cases of FD were randomly divided into a syndrome-differentiation acupuncture group , a regular acupuncture group and a non-acupoint group , 35 cases in each one .
METHODS	Zhongwan ( CV 12 ) , Tianshu ( ST 25 ) , Zusanli ( ST 36 ) were selected as main acupoints in the syndrome-differentiation acupuncture group .
METHODS	After syndrome differentiation , Danzhong ( CV 17 ) and Zhangmen ( LR 13 ) were added for those with stagnation of liver qi ; Pishu ( BL 20 ) and Weishu ( BL 21 ) were added for those with deficiency of spleen-stomach qi ; Qimen ( LR 14 ) and Taichong ( LR 3 ) were added for liver-qi invading stomach and Yinlingquan ( SP 9 ) and Neiting ( ST 44 ) were added for dampness-heat blocking stomach .
METHODS	The selection of acupoints in the regular acupuncture group was the same as main acupoints in the syndrome-differentiation acupuncture group .
METHODS	The points 10 mm lateral to the main acupoints were selected in the non-acupoint group .
METHODS	The treatment was given once a day , six days as a treatment course and totally two courses were required .
METHODS	The symptom total score , health-related quality of life survey ( SF-36 ) and Nepean dyspepsia index ( NDI ) were evaluated before and after the treatment as well as one month after the treatment ( follow-up visit ) , respectively .
METHODS	The efficacy was also assessed .
RESULTS	After the treatment , the total effective rate was 87.5 % ( 28/32 ) in the syndrome-differentiation acupuncture group , which was superior to 74.2 % ( 23/31 ) in the regular acupuncture group and 20.7 % ( 6/29 ) in the non-acupoint group ( P < 0.05 , P < 0.01 ) .
RESULTS	Compared before the treatment , the SF-36 , NDI and symptom total score after the treatment and in the follow-up visit were all obviously improved in the syndrome-differentiation acupuncture group and regular acupuncture group ( all P < 0.05 ) , which was the most obvious in the syndrome-differentiation acupuncture group [ after the treatment , SF-36 : 84.54 + / - 5.93 vs 81.44 + / - 6.22 , 63.46 + / - 6.59 ; NDSI : 18.94 + / - 9.30 vs 21.23 + / - 8.39 , 43.93 + / - 11.26 ; NDLQI : 71.42 + / - 7.23 vs 63.11 + / - 7.06 , 54.87 + / - 6.00 ; symptom total score : 22.06 + / - 15.80 vs 32.52 + / - 16.88 , 47.97 + / - 10.92 ] ; the improvement in the regular acupuncture group was more obvious than that in the non-acupoint group ( P < 0.01 , P < 0.05 ) .
RESULTS	Compared before the treatment , only NDSI score was improved in the non-acupoint group after the treatment ( P < 0.05 ) .
CONCLUSIONS	The syndrome-differentiation acupuncture could obviously improve patient 's life quality in the treatment of FD , which is an effective therapy for FD .

###25610918
OBJECTIVE	To assess the efficacy of a mouthwash containing 2 % green tea as compared to a placebo mouthwash for the control of plaque and gingivitis .
METHODS	A randomised controlled clinical trial was conducted on 110 male subjects 18-60 years of age .
METHODS	The inclusion criteria were having a minimum of 20 sound natural teeth , a plaque index ( PI ) of at least 1.5 and a gingival index ( GI ) of at least 1.0 .
METHODS	The subjects were randomised into two parallel groups , test and control .
METHODS	Subjects in the test group and control group were instructed to rinse twice daily for 1 min with 10 ml of test ( mouthwash containing 2 % green tea ) and placebo mouthwash , respectively .
METHODS	After 28 days of using the mouthwash , inter - and intragroup differences for mean plaque index and gingival index scores were analysed .
RESULTS	There was a significant ( p < 0.05 ) reduction in mean GI and PI scores among the test group from baseline to 28 days , whereas it was not significant in the control group .
RESULTS	A statistically significant ( p < 0.05 ) reduction was found in the mean difference in GI scores in the test group ( 0.67 0.22 ) as compared to the control group ( 0.05 0.11 ) and a statistically significant ( p < 0.05 ) reduction was observed in the mean difference in PI scores in the test group ( 1.65 0.68 ) compared to the control group ( 0.45 0.99 ) .
CONCLUSIONS	The results showed that the green tea mouthwash was effective in the reduction of plaque and gingivitis scores .

###25844756
OBJECTIVE	Mixed ( subsyndromal hypomanic ) features are prevalent in patients with bipolar depression and are associated with more severe and complex illness , including increased risk for suicide attempts , higher switch to mania during antidepressant therapy , and a higher rate of recurrence .
OBJECTIVE	The aim of this post hoc analysis was to evaluate the efficacy and safety of lurasidone in the treatment of patients with bipolar depression presenting with mixed features .
METHODS	Patients with a DSM-IV-TR diagnosis of major depressive episode associated with bipolar I disorder , with or without rapid cycling , and with a Montgomery-Asberg Depression Rating Scale ( MADRS ) score 20 and a Young Mania Rating Scale ( YMRS ) score 12 were randomly assigned to 6 weeks of double-blind , once-daily treatment with lurasidone 20-60 mg , lurasidone 80-120 mg , or placebo .
METHODS	The presence of mixed features was defined as a YMRS score 4 at study baseline .
METHODS	Efficacy analyses included change in MADRS total score from baseline to week 6 ( the primary outcome in the original study , conducted between April 2009 and February 2012 ) .
RESULTS	At baseline , mixed features were present in 56 % of patients ( lurasidone , n = 182/323 ; placebo , n = 90/162 ) .
RESULTS	Treatment with lurasidone ( vs placebo ) was associated with significantly greater reductions in MADRS scores in the mixed features group ( -15.7 vs -10.9 ; P = .001 ; week 6 ; mixed model for repeated measures [ MMRM ] ; effect size , 0.48 ) and in the group without mixed features ( -15.2 vs -10.8 ; P = .002 ; week 6 ; MMRM ; effect size , 0.48 ) .
RESULTS	Rates of protocol-defined treatment-emergent hypomania or mania were similar for patients with mixed features ( lurasidone , 2.2 % ; placebo , 3.2 % ) and without mixed features ( lurasidone , 3.4 % ; placebo , 0.0 % ) .
CONCLUSIONS	Lurasidone was found in this post hoc analysis to be efficacious in the treatment of patients with bipolar depression who present with mixed features ( assessed cross-sectionally at study baseline ) .
CONCLUSIONS	No increased risk of treatment-emergent mania was observed in either group .
BACKGROUND	ClinicalTrials.gov identifier : NCT00868699 .

###25207898
OBJECTIVE	The present study observed the clinical outcomes of the sodium cantharidinate/vitamin B6/GP regimen in the treatment of middle-late stage Non-small-cell lung carcinoma ( NSCLC ) .
METHODS	Eighty-six cases of NSCLC were selected and randomized into two groups .
METHODS	Forty-five cases in the treatment group were subject to 30 ml cantharidinate/vitamin B6 + GP regimen , for four 21-day cycles .
METHODS	Forty-one cases in the control group were subject to regular GP regimen , for four 21-day cycles .
RESULTS	The effectiveness rate was 57.8 % in the treatment group and 36.6 % in the control group , suggesting statistical difference ( P < 0.05 ) ; life quality in the treatment group was significantly better than that in the control group ( P < 0.05 ) ; the occurrence rate of the toxic/adverse effects were significantly lower in the treatment group compared with that in the control group ( P < 0.05 ) .
CONCLUSIONS	Sodium cantharidinate/vitamin B6/GP regimen had fair effectiveness and synergistically improved the clinical outcomes .
CONCLUSIONS	It lowered the toxic/adverse effects and its application is worth further investigation and promotion .

###25145375
BACKGROUND	Approximately 70 % of homeless youth smoke cigarettes , but their use of alternative tobacco products ( ATPs ) is unknown .
BACKGROUND	This paper reports on ATP use among past-month smokers in Los Angeles County , including whether it differs by demographic characteristics , homelessness severity , past-year quit attempts , and readiness to quit smoking .
BACKGROUND	Given the growing popularity of e-cigarettes , we also report on perceptions of harm and reasons for using this product .
METHODS	We surveyed 292 unaccompanied homeless youth who were randomly sampled from street sites .
METHODS	Participants had smoked at least 100 cigarettes during their lifetime and 1 cigarette during the past month .
RESULTS	Seventy-two percent of youth reported past-month ATP use ( e-cigarettes = 51 % ; little cigars/cigarillos = 46 % ; hookah = 31 % ; other smokeless tobacco product = 24 % ; chewing tobacco/moist snuff = 19 % ) .
RESULTS	Current ATP use was unrelated to most demographic characteristics or having a past-year quit attempt .
RESULTS	However , youth who planned to quit smoking in the next 30 days were significantly less likely to report current use of hookahs , other smokeless tobacco products , or e-cigarettes .
RESULTS	Among lifetime e-cigarette users , the most common reasons for use included not having to go outside to smoke ( 38 % ) and being able to deal with situations or places where they can not smoke ( 36 % ) ; it was less common to report using e-cigarettes to quit smoking ( 17 % -18 % ) .
CONCLUSIONS	Dual use of ATPs among homeless youth smokers is common and is more likely among those who have no immediate plans to quit smoking .
CONCLUSIONS	Effective and easily disseminable strategies for reducing all forms of tobacco use among homeless youth are urgently needed .

###25231089
BACKGROUND	Rifabutin has been known to be effective in multidrug-resistant Helicobacter pylori-harboring patients undergoing treatment failure for H. pylori infection .
OBJECTIVE	To evaluate the efficacy of 7-day treatment regimen consisting rifabutin daily but increasing the dose of amoxicillin and lansoprazole in patients who have failed first and second eradication and to assess the side effect profiles in South Korea .
METHODS	From December 2007 to May 2013 , 59 H. pylori-infected patients with two previous eradication failures were enrolled for this study prospectively .
METHODS	The eligible patients were randomly assigned to either group A or B. Group A received lansoprazole 30 mg bid , amoxicillin 1.0 g tid and rifabutin 150 mg bid during 7 days , whereas group B received lansoprazole 60 mg bid , amoxicillin 1.0 g tid and rifabutin 150 mg bid during 7 days .
RESULTS	In group A , H. pylori eradication was achieved in 25 ( 78.1 % ) of the 32 patients in the ITT analysis and in 25 ( 80.6 % ) of the 31 patients in the PP analysis .
RESULTS	In group B , H. pylori eradication was achieved in 26 ( 96.3 % ) of the 27 patients in the ITT analysis and in 27 ( 100 % ) of the 26 patients in the PP analysis .
RESULTS	There was statistically significant difference between the two groups in terms of the eradication rates in PP analysis ( p = .047 ) , whereas a marginally statistical significance was found in terms of the eradication rates in ITT analysis ( p = .051 ) .
RESULTS	Reported side effects were mild , and treatment was well tolerated .
RESULTS	No major changes in physical examination or in standard laboratory parameters were observed after treatment .
CONCLUSIONS	Rifabutin-based high-dose proton-pump inhibitor ( PPI ) - combined therapy as empirical rescue treatment is more effective than standard dose PPI-combined rifabutin-based therapy , safe and best tolerable in third-line therapy in the Korean population .
CONCLUSIONS	The key to successful rescue therapy with rifabutin-amoxicillin-PPI regimen may be to increase doses of PPI .

###25184862
BACKGROUND	This open-label , randomized , phase 3 study compared melphalan at a dose of 200 mg per square meter of body-surface area plus autologous stem-cell transplantation with melphalan-prednisone-lenalidomide ( MPR ) and compared lenalidomide maintenance therapy with no maintenance therapy in patients with newly diagnosed multiple myeloma .
METHODS	We randomly assigned 273 patients 65 years of age or younger to high-dose melphalan plus stem-cell transplantation or MPR consolidation therapy after induction , and 251 patients to lenalidomide maintenance therapy or no maintenance therapy .
METHODS	The primary end point was progression-free survival .
RESULTS	The median follow-up period was 51.2 months .
RESULTS	Both progression-free and overall survival were significantly longer with high-dose melphalan plus stem-cell transplantation than with MPR ( median progression-free survival , 43.0 months vs. 22.4 months ; hazard ratio for progression or death , 0.44 ; 95 % confidence interval [ CI ] , 0.32 to 0.61 ; P < 0.001 ; and 4-year overall survival , 81.6 % vs. 65.3 % ; hazard ratio for death , 0.55 ; 95 % CI , 0.32 to 0.93 ; P = 0.02 ) .
RESULTS	Median progression-free survival was significantly longer with lenalidomide maintenance than with no maintenance ( 41.9 months vs. 21.6 months ; hazard ratio for progression or death , 0.47 ; 95 % CI , 0.33 to 0.65 ; P < 0.001 ) , but 3-year overall survival was not significantly prolonged ( 88.0 % vs. 79.2 % ; hazard ratio for death , 0.64 ; 95 % CI , 0.36 to 1.15 ; P = 0.14 ) .
RESULTS	Grade 3 or 4 neutropenia was significantly more frequent with high-dose melphalan than with MPR ( 94.3 % vs. 51.5 % ) , as were gastrointestinal adverse events ( 18.4 % vs. 0 % ) and infections ( 16.3 % vs. 0.8 % ) ; neutropenia and dermatologic toxic effects were more frequent with lenalidomide maintenance than with no maintenance ( 23.3 % vs. 0 % and 4.3 % vs. 0 % , respectively ) .
CONCLUSIONS	Consolidation therapy with high-dose melphalan plus stem-cell transplantation , as compared with MPR , significantly prolonged progression-free and overall survival among patients with multiple myeloma who were 65 years of age or younger .
CONCLUSIONS	Lenalidomide maintenance , as compared with no maintenance , significantly prolonged progression-free survival .
CONCLUSIONS	( Funded by Celgene ; ClinicalTrials.gov number , NCT00551928 . )

###26095256
BACKGROUND	The Stockholm III Trial randomized patients with primary operable rectal cancers to either short-course radiotherapy ( RT ) with immediate surgery ( SRT ) , short-course RT with surgery delayed 4-8 weeks ( SRT-delay ) or long-course RT with surgery delayed 4-8 weeks .
BACKGROUND	This preplanned interim analysis examined the pathological outcome of delaying surgery .
METHODS	Patients randomized to the SRT and SRT-delay arms in the Stockholm III Trial between October 1998 and November 2010 were included , and data were collected in a prospective register .
METHODS	Additional data regarding tumour regression grade , according to Dworak , and circumferential margin were obtained by reassessment of histopathological slides .
RESULTS	A total of 462 of 545 randomized patients had specimens available for reassessment .
RESULTS	Patients randomized to SRT-delay had earlier ypT categories , and a higher rate of pathological complete responses ( 118 versus 17 per cent ; P = 0001 ) and Dworak grade 4 tumour regression ( 101 versus 17 per cent ; P < 0001 ) than patients randomized to SRT without delay .
RESULTS	Positive circumferential resection margins were uncommon ( 63 per cent ) and rates did not differ between the two treatment arms .
CONCLUSIONS	Short-course RT induces tumour downstaging if surgery is performed after an interval of 4-8 weeks .

###25180609
BACKGROUND	Colonoscopy requires effective bowel preparation for adequate mucosal visualization .
BACKGROUND	Safety and acceptability of bowel preparation are key components in colorectal cancer screening ( CRC ) populations .
OBJECTIVE	To compare the efficacy , safety and acceptability of bowel preparation with polyethylene glycol ( PEG ) , ascorbic acid , sodium ascorbate ( ascorbate components ) , sodium sulfate and electrolytes ( PEG+A sc ) or sodium phosphate ( NaP ) .
METHODS	Consenting adults undergoing elective out-patient colonoscopy for CRC were randomized to take 2 L PEG+A sc or 90 mL NaP ( control ) following manufacturer 's instructions .
METHODS	PEG+A sc was taken the evening before and morning of the colonoscopy ; NaP was taken the morning and evening before colonoscopy .
METHODS	Participants followed a restricted diet specific to each preparation .
METHODS	Primary endpoint was bowel cleansing success ( 100 % colon mucosa visible ) rated by an independent expert panel ( all experienced endoscopists ) unaware of treatment allocations .
METHODS	Subject reported outcomes about the preparations were elicited .
METHODS	Adverse events were recorded .
BACKGROUND	Clinicaltrials.gov : NCT00427089 .
RESULTS	Successful bowel cleansing rate was significantly higher in the PEG+A sc ( N = 242 ) than the NaP ( N = 114 ) group ( PEG+A sc 93.4 % [ 95 % CI 89.5-96 .2 ] versus NaP 22.8 % [ 15.5-31 .6 % ] , p < 0.0001 ) .
RESULTS	Subject reported outcomes on acceptability of the two different preparations were not significantly different ( p = 0.238 ) .
RESULTS	However , taste ratings for PEG+A sc were significantly better versus NaP ( mean VAS : 31.2 and 38.1 respectively , p = 0.0111 ) .
RESULTS	The proportion of patients prepared to receive the same preparation again was significantly higher in the PEG+A sc group ( 88.4 % vs. 78.1 % , p < 0.0001 ) .
CONCLUSIONS	PEG+A sc provided superior bowel cleansing to NaP and was well tolerated .
CONCLUSIONS	Findings for PEG+A sc are aligned with previous similar studies ; however , differences observed in NaP cleansing results , especially for the proximal colon segments , may be due to factors including : differences in demographics and population types and the use of the validated Harefield Cleansing Scale as an assessment tool combined with expert reviews , which may have resulted in conservative cleansing assessments .

###24852756
BACKGROUND	Recent studies show that enzymatically hydrolysed collagen , the collagen peptide , is absorbed and distributed to joint tissues and has analgesic and anti-inflammatory properties .
BACKGROUND	A double-blind , placebo-controlled , randomised trial with collagen peptides isolated from pork skin ( PCP ) and bovine bone ( BCP ) sources was carried out to study the effectiveness of orally supplemented collagen peptide to control the progression of osteoarthritis in patients diagnosed with knee osteoarthritis .
BACKGROUND	Improvement in treatment was assessed with reduction in Western Ontario McMaster Universities ( WOMAC ) , visual analogue scale ( VAS ) and quality of life ( QOL ) scores from baseline to 13 weeks ( Visit 7 ) .
BACKGROUND	Safety and tolerability were also evaluated .
RESULTS	There was significant reduction from baseline to Visit 7 in the primary end points of WOMAC and VAS scores and in the secondary end point of QOL score in subjects with PCP and BCP groups , while in subjects with placebo group the end point indices remained unaltered .
RESULTS	Furthermore , all the score levels of WOMAC , VAS and QOL decreased significantly ( P < 0.01 ) in the study group compared to placebo group in Visit 7 .
CONCLUSIONS	The study demonstrated that collagen peptides are potential therapeutic agents as nutritional supplements for the management of osteoarthritis and maintenance of joint health .

###24854755
OBJECTIVE	To explore the feasibility , advantages and clinical value of gasless abdominal-wall lifting laparoscopic myomectomy with 5 mm laparoscope and 2 abdominal holes ( 1.5-hole-gasless-laparoscopic myomectomy ) .
METHODS	A total of 90 cases of uterine fibroids were randomly divided into 2 groups .
METHODS	Lifting gasless group ( n = 46 ) underwent gasless abdominal-wall lifting laparoscopic myomectomy with 5 mm laparoscope and 2 abdominal holes , and pneumoperitoneum group ( n = 44 ) pneumoperitoneum laparoscopic myomectomy .
METHODS	The operative duration , blood loss volume , average time of single-myoma-removal , intestinal function recovery and hospital stay of both groups were compared .
RESULTS	The operative duration , blood loss volume and average time of single-myoma-removal of lifting gasless group were respectively significantly less than those of pneumoperitoneum group ( P < 0.01 ) .
RESULTS	The postoperative intestinal function recovery and postoperative hospital stay had no significant difference between two groups ( P > 0.05 ) .
RESULTS	Three cases of pneumoperitoneum group were converted successfully into myomectomy with traditional 3-hole gasless abdominal wall lifting laparoscopy because of large fibroids in uterine isthmus .
RESULTS	A total of 12 newly discovered myomas , not pre-detected ultrasonically , were removed in 10 cases of lifting gasless group .
CONCLUSIONS	1.5-hole-gasless-laparoscopic myomectomy , like traditional gasless laparoscopy , may avoid the complications of laparoscopic CO2 pneumoperitoneum .
CONCLUSIONS	The smaller laparoscope-hole and sole operating hole make this maneuver a safe , easy and mini-invasive procedure .
CONCLUSIONS	It is more suitable for clinical application and popularity in primary care .

###25442342
OBJECTIVE	To identify an optimal margin about the gross target volume ( GTV ) for stereotactic radiosurgery ( SRS ) of brain metastases , minimizing toxicity and local recurrence .
METHODS	Adult patients with 1 to 3 brain metastases less than 4 cm in greatest dimension , no previous brain radiation therapy , and Karnofsky performance status ( KPS ) above 70 were eligible for this institutional review board-approved trial .
METHODS	Individual lesions were randomized to 1 - or 3 - mm uniform expansion of the GTV defined on contrast-enhanced magnetic resonance imaging ( MRI ) .
METHODS	The resulting planning target volume ( PTV ) was treated to 24 , 18 , or 15 Gy marginal dose for maximum PTV diameters less than 2 , 2 to 2.9 , and 3 to 3.9 cm , respectively , using a linear accelerator-based image-guided system .
METHODS	The primary endpoint was local recurrence ( LR ) .
METHODS	Secondary endpoints included neurocognition Mini-Mental State Examination , Trail Making Test Parts A and B , quality of life ( Functional Assessment of Cancer Therapy-Brain ) , radionecrosis ( RN ) , need for salvage radiation therapy , distant failure ( DF ) in the brain , and overall survival ( OS ) .
RESULTS	Between February 2010 and November 2012 , 49 patients with 80 brain metastases were treated .
RESULTS	The median age was 61 years , the median KPS was 90 , and the predominant histologies were non-small cell lung cancer ( 25 patients ) and melanoma ( 8 ) .
RESULTS	Fifty-five , 19 , and 6 lesions were treated to 24 , 18 , and 15 Gy , respectively .
RESULTS	The PTV/GTV ratio , volume receiving 12 Gy or more , and minimum dose to PTV were significantly higher in the 3-mm group ( all P < .01 ) , and GTV was similar ( P = .76 ) .
RESULTS	At a median follow-up time of 32.2 months , 11 patients were alive , with median OS 10.6 months .
RESULTS	LR was observed in only 3 lesions ( 2 in the 1 mm group , P = .51 ) , with 6.7 % LR 12 months after SRS .
RESULTS	Biopsy-proven RN alone was observed in 6 lesions ( 5 in the 3-mm group , P = .10 ) .
RESULTS	The 12-month DF rate was 45.7 % .
RESULTS	Three months after SRS , no significant change in neurocognition or quality of life was observed .
CONCLUSIONS	SRS was well tolerated , with low rates of LR and RN in both cohorts .
CONCLUSIONS	However , given the higher potential risk of RN with a 3-mm margin , a 1-mm GTV expansion is more appropriate .

###24268128
BACKGROUND	Depression and anxiety disorders during adolescence can have detrimental consequences .
BACKGROUND	Both disorders are related to negative outcome in various areas during adolescence and are also predictive of depression and anxiety disorders later in life .
BACKGROUND	Especially parental psychopathology and being female are risk factors that increase the probability of developing one of these disorders during adolescence .
BACKGROUND	Research has shown that prevention programs have promising results , especially for adolescents who have these risk factors .
BACKGROUND	Therefore , in this study , we will focus on the effectiveness of a prevention program ' A jump forward ' that has been developed for adolescent girls with a familial risk of depression and/or anxiety .
METHODS	We designed a randomized controlled trial to test the effectiveness of an indicated and selective prevention program aimed at depression and anxiety in adolescent girls .
METHODS	Adolescents aged between 11 and 15 years old with depressive and/or anxiety symptoms and with parents who show indicators of parental psychopathology will be randomly assigned to the experimental ( N = 80 ) or control groups ( N = 80 ) .
METHODS	Participants in the experimental group will follow a preventive intervention , consisting of six sessions of 90 minutes each .
METHODS	All participants will complete baseline , intervention phase 1 ( after session 2 ) , intervention phase 2 ( after session 4 ) , post-intervention , 6 month follow-up , and 12 month follow-up assessments .
METHODS	Furthermore , parents will be asked to complete assessments at baseline , post-intervention , and 12-month follow-up .
METHODS	Primary outcome will be depressive symptoms .
METHODS	Secondary outcomes will be anxiety symptoms , suicidal ideation , response style , negative cognitive errors , parental emotional support and parental control , parental psychopathology , parenting stress and adolescents ' depression and anxiety symptoms according to the parents .
CONCLUSIONS	This paper described the study designed to evaluate a program for preventing depression and/or anxiety in high-risk adolescents over a 12-month follow-up period .
CONCLUSIONS	If the program showed to be effective in reducing symptoms of depression and anxiety and preventing adolescents from developing clinical levels of these disorders , our results would be relevant to practice .
CONCLUSIONS	Thus , the intervention could be used on a large scale .
CONCLUSIONS	Moreover , this study aims to contribute to the evidence-based prevention of depression and anxiety of adolescents .
BACKGROUND	Dutch Trial Register NTR3720 .

###24926548
BACKGROUND	The phosphotidylinositol-3 kinase/serine-threonine kinase ( AKT ) / mammalian target of rapamycin signaling pathway is frequently altered in non-small-cell lung cancer ( NSCLC ) .
BACKGROUND	PX-866 is an oral , irreversible , pan-isoform inhibitor of phosphotidylinositol-3 kinase .
BACKGROUND	Preclinical models revealed synergy with docetaxel and a phase 1 trial demonstrated tolerability of this combination .
BACKGROUND	This randomized phase 2 study evaluated PX-866 combined with docetaxel in patients with advanced , refractory NSCLC .
METHODS	Patients with locally advanced , recurrent , or metastatic NSCLC who had received at least one and no more than two prior systemic treatment regimens were randomized ( 1:1 ) to a combination of docetaxel ( 75 mg/m intravenous every 21 days ) with or without PX-866 ( 8 mg orally daily ; arms A and B , respectively ) .
METHODS	The primary end point was progression-free survival ( PFS ) .
METHODS	Secondary end points included objective response rate , overall survival ( OS ) , toxicity , and correlation of biomarker analyses with efficacy outcomes .
RESULTS	A total of 95 patients were enrolled .
RESULTS	Median PFS was 2 months in arm A and 2.9 months in arm B ( p = 0.65 ) .
RESULTS	Objective response rates were 6 % and 0 % in arms A and B , respectively ( p = 0.4 ) .
RESULTS	There was no difference in OS between the two arms ( 7.0 versus 9.2 months ; p = 0.9 ) .
RESULTS	Grade 3 or higher adverse events were infrequent , but more common in the combination arm with respect to diarrhea ( 7 % versus 2 % ) , nausea ( 4 % versus 0 % ) , and vomiting ( 7 % versus 0 % ) .
RESULTS	PIK3CA mutations or PTEN loss were infrequently observed .
CONCLUSIONS	The addition of PX-866 to docetaxel did not improve PFS , response rate , or OS in patients with advanced , refractory NSCLC without molecular preselection .

###24290600
OBJECTIVE	Earlier studies on the management of metabolic syndrome ( MetS ) have mostly focused on very low carbohydrate diets , whereas long-term adherence to such diets is difficult for apparently healthy people .
OBJECTIVE	The aim of this study was to examine the effects of moderate replacement of carbohydrates by dietary fats on insulin resistance and features of MetS among women .
METHODS	This randomized crossover clinical trial was performed with 30 overweight or obese ( body mass index [ BMI ] > 25 kg/m ( 2 ) ) women with MetS .
METHODS	After a 2-wk run-in period , participants were randomly assigned to consume either a calorie-restricted high-carbohydrate ( HC ) diet ( 60 % -65 % of energy from carbohydrates and 20 % -25 % from fats ) or a calorie-restricted moderately restricted carbohydrate ( MRC ) diet ( 43 % -47 % of total calories as carbohydrate and 36 % -40 % as dietary fats ) for 6 wk .
METHODS	Protein contents of both diets were 15 % to 17 % of total energy .
METHODS	A 2-wk washout period was applied following which participants were crossed over to the alternate treatment arm for an additional 6 wk .
METHODS	Anthropometric , blood pressure , and biochemical measurements were performed before and after each phase of intervention .
RESULTS	Mean age and BMI of study participants was 42.4 y and 33 kg/m ( 2 ) , respectively .
RESULTS	A trend toward greater reduction in waist ( -3.9 versus -2.6 cm ; P = 0.07 ) and hip circumferences ( -2.7 versus -1.5 cm ; P = 0.07 ) as well as serum triglyceride ( TG ) levels ( -31.3 versus 0.13 mg/dL ; P = 0.07 ) was observed after consumption of an MRC diet compared with an HC diet .
RESULTS	The TG to high-density lipoprotein cholesterol ( HDL-C ) ratio had a tendency to improve with the MRC diet rather than the HC diet ( -0.9 versus -0.1 ; P = 0.06 ) .
RESULTS	Consumption of the MRC diet resulted in a greater reduction of systolic blood pressure ( -8.93 versus -2.97 mm Hg ; P = 0.06 ) and diastolic blood pressure ( -12.7 versus -1.77 mm Hg ; P = 0.001 ) compared with the HC diet .
RESULTS	The prevalence of MetS was significantly decreased following the consumption of the MRC diet ( P = 0.03 ) .
RESULTS	The two diets were not significantly different in terms of their effect on fasting plasma glucose , serum HDL-C , low-density lipoprotein cholesterol , and total cholesterol , insulin levels , and Homeostasis Model Assessment-Insulin Resistance .
CONCLUSIONS	Moderate replacement of carbohydrates by dietary fats was not associated with statistically different changes in fasting plasma glucose , insulin , or atherogenic dyslipidemia among individuals with the metabolic syndrome ; however , it resulted in decreased diastolic blood pressure and lower prevalence of the metabolic syndrome .

###24967744
OBJECTIVE	Lymphoceles are among the most common post-operative complications of pelvic lymphadenectomy , with a reported incidence of 1 % to 29 % in gynecology oncology .
OBJECTIVE	Several studies evaluated the effectiveness of biological glues on reducing lymphoceles , but no data on gynecological patients are available .
OBJECTIVE	We evaluated the effectiveness of cyanoacrylic glues ( n-butyl cyanoacrylate ) ( Glubran 2 - GEM s.r.l. , Italy ) in preventing lymphocele on 30 patients who underwent pelvic lymphadenectomy for endometrial or cervical cancer .
METHODS	Single-blind prospective randomized study .
METHODS	Patients were divided into 2 groups : pelvic lymphadenectomy plus n-butyl cyanoacrylate ( treatment group : 44 patients ) and pelvic lymphadenectomy without n-butyl cyanoacrylate ( control group : 44 patients ) .
METHODS	Primary endpoint was incidence of pelvic lymphocele in the two groups 30 days after surgery , and evaluated with pelvic ultrasound and RMI examination .
METHODS	Secondary endpoints evaluated drainage volume of lymphorrhea 36 , 48 , 72 and 96 h after surgery .
RESULTS	15 % in the treatment group and 36.6 % in the control group had lymphocele 1month after the procedure ( p < 0.03 ; RR 0.4 [ 95 % CI 0.152-0 .999 ] ) .
RESULTS	Concerning the secondary outcome in group A the amount of lymphorrhea presented a constant significant decrease during evaluation ; on the contrary , in group B , after an initial decrease at 48 h , the amount of lymphorrhea remained unchanged ; at all considered times the amount of lymphorrhea resulted significantly greater in controls .
CONCLUSIONS	Intraoperative application of n-butyl cyanoacrylate seems to reduce lymph production after pelvic lymphadenectomy , providing a useful additional treatment option for reducing drainage volume and preventing lymphocele development after pelvic lymphadenectomy .

###24796057
OBJECTIVE	To observe the clinical effect of electric stimulation of long-term retaining needle on analgesia after laparoscopic cholecystectomy ( LC ) and the impacts on the post-surgical flatus time .
METHODS	Under static absorptive composite general anesthesia , 90 cases of LC were randomized into three groups , 30 cases in each one .
METHODS	In the control group , the analgesia was not applied after LC .
METHODS	In the analgesia-pumper group , the patient controlled intravenous analgesia ( PCIA ) was used .
METHODS	In the needle-retaining group , the electric acupuncture stimulator was used .
METHODS	The needles were inserted transversely at Riyue ( GB 24 ) , Qichong ( ST 30 ) and Yanglingquan ( GB 34 ) and fixed with sterile sticker .
METHODS	Separately , in 8 h and 24 h after surgery , the electric acupuncture stimulation with disperse-dense wave , 2 Hz/100 Hz frequency was applied continuously for 30 min .
METHODS	Visual analogue scale ( VAS ) , adverse reactions such as vomiting and nausea and the postoperative flatus time in 2 , 4 , 8 , 12 , 24 and 36 h after surgery were observed and recorded in the three groups .
RESULTS	In 2 , 4 , 8 , 12 and 24 h after surgery , VAS scores in the needle-retaining group and the analgesia-pumper group were all lower than those in the control group ( P < 0.05 , P < 0.01 ) .
RESULTS	The analgesia effect at the above time points in the needle-retaining group was better than that in the analgesia-pumper group ( all P < 0.05 ) .
RESULTS	There was not adverse reaction in the needle-retaining group .
RESULTS	But there were 3 cases of somnolence , 6 cases of nausea and 3 cases of vomiting in the analgesia-pumper group , and 2 cases of nausea and 1 case of vomiting in the control group .
RESULTS	The flatus time was quite earlier in the needle-retaining group as compared with the other two groups [ ( 14.77 + / - 4.99 ) h vs ( 18.50 + / - 4.22 ) h , P < 0.01 ; ( 14.77 + / - 4.99 ) h vs ( 18.17 + / - 4.69 ) h , P < 0.05 ] .
CONCLUSIONS	The electric stimulation of long-term retaining needle is safe and effective in analgesia after LC .
CONCLUSIONS	It avoids the adverse reactions of analgesics and promotes postoperative flatus .

###24398192
BACKGROUND	Recently , we have shown advantages of a direct optical entry ( DOE ) using a bladeless trocar in comparison with the open Hasson technique ( OHT ) in older reproductive-age women with previous operations , as well as in comparison with Veress needle entry in reproductive-age and postmenopausal women .
OBJECTIVE	A prospective multicenter randomized study to determine whether the DOE is feasible for establishing safe and rapid entry into the abdomen in comparison with those of the OHT in reproductive-age obese women .
METHODS	Two types of surgical techniques were blindly applied in 224 obese reproductive-age women with benign neoplastic diseases of ovary and uterus .
METHODS	Namely , laparoscopic entry into the abdomen in 108 patients was performed by DOE and in 116 women by OHT .
METHODS	Following parameters ( entry time in seconds needed to establish the intra-abdominal vision after pneumoperitoneum , blood loss , occurrence of vascular and/or bowel injuries ) were compared during surgery as main outcomes .
RESULTS	Main baseline characteristics of patients , including age ( 36.1 4.5 vs 35.7 5.8 ) , body mass index ( 34.9 5.1 vs 35.1 4.9 kg/m ( 2 ) ) , and parity ( 2.1 0.4 vs 1.9 0.9 ) , were not significantly different between the DOE and OHT groups ( P > .05 ) .
RESULTS	While intraoperative parameters such as the entry time ( 71.9 3.7 vs 215.1 6.2 seconds ) and blood loss value ( 9.7 6.1 vs 12.2 2.9 mL ) were significantly reduced in the DOE group in comparison with those of OHT group ( respectively , P < .0001 and < .01 ) , there were also trends to slight decrease of the occurrence of the minor injuries , manifested as omental small vessels rupture ( 0 of 108 vs 4 of 116 ) and punctures and pinches of jejunal serosa ( 0 of 108 vs 3 of 116 ) in patients of the DOE group in comparison with those of OHT group ( respectively , P = .0515 and = .0925 ) .
CONCLUSIONS	DOE reduced entry time and blood loss with trends to slightly decrease of the occurrence of the minor vascular and bowel injuries , thus enabling a possible alternative to OHT in obese women ; however , further larger trials need to confirm the possible additional benefits of a DOE .

###25083601
BACKGROUND	Family carers of people with dementia frequently become depressed or anxious .
BACKGROUND	In observational studies , more emotion-focused and less dysfunctional coping predict fewer psychological symptoms , but no randomised controlled trial ( RCT ) has directly investigated emotion-focused coping as mediator of effectiveness of a successful psychological intervention .
BACKGROUND	We hypothesised that emotion-focused coping would mediate the START psychological interventions effects in an RCT .
BACKGROUND	We tested whether mediated effects were moderated by severity of baseline symptoms .
METHODS	260 family carers from NHS dementia services were randomised to START ( manualised coping skills intervention ) , or treatment-as-usual ( TAU ) .
METHODS	Blinded raters administered the Hospital Anxiety and Depression Scale ( HADS-T ) and Brief COPE inventory at baseline , 4 and 8 months .
METHODS	HADS-T improved in the intervention group when compared to TAU at all levels of psychological distress .
METHODS	We tested whether coping was a mediator and for moderated mediation , and ( post-hoc ) subgroup treatment effects on coping .
RESULTS	Data were available for 187 carers ( 71.9 % ) for the mediation analysis .
RESULTS	The reduced HADS-T score in the intervention group was mediated by increased emotion-focused coping only among carers with higher ( 16 + ) baseline HADS-T scores ( mediated effect = -0.63 [ -1.11 , -0.15 ] ; proportion of overall effect = 33 % [ 3 % , 64 % ] ) .
CONCLUSIONS	We did not measure plausible psychosocial treatment mechanisms other than coping .
CONCLUSIONS	START benefited family carers both in preventing and treating psychological morbidity , through different mechanisms of action .
CONCLUSIONS	The most psychologically distressed carers increased their emotion-focused coping and did not decrease their dysfunctional coping , while others benefited but not through this mechanism .

###24476454
OBJECTIVE	To investigate the effect of 2 commonly used mydriatics on choroidal thickness using enhanced depth imaging optical coherence tomography ( EDI-OCT ) .
METHODS	In this prospective study , 90 healthy subjects were enrolled .
METHODS	The participants were randomly divided into 3 groups based on the application of drops .
METHODS	One eye of each subject received a drop of tropicamide 1 % in the tropicamide group ( n = 30 ) , a drop of phenylephrine 2.5 % in the phenylephrine group ( n = 30 ) , and a drop of artificial tear in the control group ( n = 30 ) .
METHODS	Drops were given thrice at 5min intervals .
METHODS	Subfoveal choroidal thickness ( SFCT ) was measured using EDI-OCT before and at 45min after drop application in both the dilated eye and nondilated contralateral eye .
RESULTS	The SFCT was significantly decreased after drop instillation in both the dilated eye and contralateral eye in the tropicamide group ( P < 0.001 and P = 0.001 , respectively ) and in the phenylephrine group ( P < 0.001 and P = 0.001 , respectively ) .
RESULTS	However , the SFCT did not significantly differ after drop instillation in either the dropped eye or contralateral eye in the control group ( P = 0.108 and P = 0.695 , respectively ) .
CONCLUSIONS	The findings of the present study revealed that tropicamide and phenylephrine cause a decrease in choroidal thickness .

###25010823
BACKGROUND	An inhaled gas absolute humidity of 20 mg H2OL is the value most considered as the threshold necessary for preventing the deleterious effects of dry gas on the epithelium of the airways during anesthesia .
BACKGROUND	Because children have small minute ventilation , we hypothesized that the humidification of a circle breathing system is lower in children compared with adults .
BACKGROUND	The Primus anesthesia workstation ( Drger Medical , Lbeck , Germany ) has a built-in hotplate to heat the patient 's exhaled gases .
BACKGROUND	A heat and moisture exchanger ( HME ) is a device that can be used to further humidify and heat the inhaled gases during anesthesia .
BACKGROUND	To evaluate the humidifying properties of this circle breathing system during pediatric anesthesia , we compared the temperature and humidity of inhaled gases under low or high fresh gas flow ( FGF ) conditions and with or without an HME .
METHODS	Forty children were randomly allocated into 4 groups according to the ventilation of their lungs by a circle breathing system in a Drger Primus anesthesia workstation with low ( 1 Lmin ) or high ( 3 Lmin ) FGF without an HME ( 1L and 3L groups ) or with an HME ( Pall BB25FS , Pall Biomedical , East Hills , NY ; HME1L and HME3L groups ) .
METHODS	The temperature and absolute humidity of inhaled gases were measured at 10 , 20 , 40 , 60 , and 80 minutes after connecting the patient to the breathing circuit .
RESULTS	The mean inhaled gas temperature was higher in HME groups ( HME1L : 30.3 C 1.1 C ; HME3L : 29.3 C 1.2 C ) compared with no-HME groups ( 1L : 27.0 C 1.2 C ; 3L : 27.1 C 1.5 C ; P < 0.0001 ) .
RESULTS	The mean inhaled gas absolute humidity was higher in HME than no-HME groups and higher in low-flow than high-flow groups ( [ HME1L : 25 1 mg H2OL ] > [ HME3L : 23 2 mg H2OL ] > [ 1L : 17 1 mg H2OL ] > [ 3L : 14 1 mg H2OL ] ; P < 0.0001 ) .
CONCLUSIONS	In a pediatric circle breathing system , the use of neither high nor low FGF provides the minimum humidity level of the inhaled gases thought to reduce the risk of dehydration of airways .
CONCLUSIONS	Insertion of an HME increases the humidity and temperature of the inhaled gases , bringing them closer to physiological values .
CONCLUSIONS	The use of a low FGF enhances the HME efficiency and consequently increases the inhaled gas humidity values .
CONCLUSIONS	Therefore , the association of an HME with low FGF in the breathing circuit is the most efficient way to conserve the heat and the moisture of the inhaled gas during pediatric anesthesia .

###25447575
OBJECTIVE	De novo donor-specific anti-human leukocyte antigen antibodies develop in a high proportion of lung transplant recipients early after lung transplantation .
OBJECTIVE	We recently showed that de novo donor-specific antibodies ( DSA ) occurrence is associated with significantly increased mortality .
OBJECTIVE	Here , we studied the efficacy of a preemptive treatment protocol .
METHODS	A retrospective observational study was conducted on all lung transplantations at Hanover Medical School between January 2009 and May 2013 .
RESULTS	Among the 500 transplant recipients , early DSA developed in 86 ( 17 % ) .
RESULTS	Of these , 56 patients ( 65 % ; Group A ) received therapeutic plasma exchange , and 30 patients ( 35 % ; Group B ) did not .
RESULTS	Among Group A patients , 51 also received rituximab .
RESULTS	Between groups , there was no statistically significant difference in mortality , incidence of pulsed steroid therapies , rejections diagnosed by biopsy specimen , incidence of bronchitis obliterans syndrome ( BOS ) , or infections requiring hospitalization at 1 year and 3 years .
RESULTS	Also , there were no statistically significant differences after matching 21 Group A with 21 Group B patients through propensity score analysis .
RESULTS	Significantly more Group A patients ( 65 % ) than Group B patients ( 34 % ) cleared DSA at hospital discharge ( p = 0.01 ) .
RESULTS	At the last control after transplantation ( median , 14 months ; interquartile range , 5-24 months ) , 11 Group A ( 22 % ) and 9 Group B patients ( 33 % ) still showed DSA ( p = 0.28 ) .
CONCLUSIONS	Preemptive treatment with therapeutic plasma exchange and rituximab led to improved elimination of DSA early after lung transplantation ( p = 0.01 ) .
CONCLUSIONS	However , spontaneous elimination in untreated Group B patients also occurred frequently .
CONCLUSIONS	This treatment protocol was not associated with significantly improved outcome .

###25929530
BACKGROUND	Low back pain is often accepted as a `` normal '' part of pregnancy .
BACKGROUND	Despite research suggesting that quality of life for women who are pregnant is adversely affected , most are advised to self-manage .
BACKGROUND	Although the use of acupuncture for the management of persistent nonspecific low back pain has been recommended in recent UK national guidelines , its use in the management of pregnancy-related low back pain remains limited .
OBJECTIVE	This study aimed to explore the perceptions and experiences of physical therapists involved in treating women who are pregnant and have low back pain with the objective of informing the pretrial training program for a pilot randomized trial ( Evaluating Acupuncture and Standard care for pregnant womEn with Back pain [ EASE Back ] ) .
METHODS	A qualitative phenomenological method with purposive sampling was used in the study .
METHODS	Three focus groups and 3 individual semistructured interviews were undertaken , and an iterative exploratory thematic analysis was performed .
METHODS	To ensure transparency of the research process and the decisions made , an audit trail was created .
RESULTS	Twenty-one physical therapists participated , and emergent issues included : a lack of experience in treating pregnancy-related complaints , mixed messages from previous acupuncture education , a mistrust of the current evidence for acupuncture safety and effectiveness , and personal and professional fear of causing harm .
CONCLUSIONS	The findings suggest that UK physical therapists are reluctant to use acupuncture in the management of pregnancy-related low back pain .
CONCLUSIONS	The explanations for these findings include perceived lack of knowledge and confidence , as well as a pervasive professional culture of caution , particularly fears of inducing early labor and of litigation .
CONCLUSIONS	These findings have been key to informing the content of the training program for physical therapists delivering acupuncture within the pilot EASE Back trial .

###24890738
BACKGROUND	Tiotropium , a once-daily long-acting anticholinergic bronchodilator , when administered via Respimat SoftMist inhaler ( tiotropium Respimat ) significantly reduces the risk of severe exacerbations and improves lung function in patients with severe persistent asthma that is not fully controlled despite using inhaled corticosteroids ( ICS ) and long-acting 2-agonists .
BACKGROUND	To further explore the dose-response curve in asthma , we investigated the efficacy and safety of three different doses of tiotropium Respimat as add-on to ICS in symptomatic patients with moderate persistent asthma .
METHODS	In this randomised , double-blind , placebo-controlled , four-way crossover study , patients were randomised to tiotropium Respimat 5g , 2.5 g or 1.25 g or placebo Respimat , once daily in the evening .
METHODS	Each treatment was administered for 4weeks , without washout between treatment periods .
METHODS	Eligibility criteria included 60 % and 90 % of predicted normal forced expiratory volume in 1second ( FEV1 ) and seven-question Asthma Control Questionnaire mean score of 1.5 .
METHODS	Patients were required to continue maintenance treatment with stable medium-dose ICS for at least 4weeks prior to and during the treatment period .
METHODS	Long-acting 2-agonists were not permitted during the treatment phase .
METHODS	The primary efficacy end point was peak FEV1 measured within 3hours after dosing ( peak FEV1 ( 0-3h ) ) at the end of each 4-week period , analysed as a response ( change from study baseline ) .
RESULTS	In total , 149 patients were randomised and 141 completed the study .
RESULTS	Statistically significant improvements in peak FEV1 ( 0-3h ) response were observed with each tiotropium Respimat dose versus placebo ( all P < 0.0001 ) .
RESULTS	The largest difference from placebo was with tiotropium Respimat 5g ( 188mL ) .
RESULTS	Trough FEV1 and FEV1 area under the curve ( AUC ) ( 0-3h ) responses were greater with each tiotropium Respimat dose than with placebo ( all P < 0.0001 ) , and both were greatest with 5g .
RESULTS	Peak forced vital capacity ( FVC ) ( 0-3h ) , trough FVC and FVC AUC ( 0-3h ) responses , versus placebo , were greatest with tiotropium Respimat 5g ( P < 0.0001 , P = 0.0012 and P < 0.0001 , respectively ) .
RESULTS	Incidence of adverse events was comparable between placebo and all tiotropium Respimat groups .
CONCLUSIONS	Once-daily tiotropium Respimat add-on to medium-dose ICS improves lung function in symptomatic patients with moderate asthma .
CONCLUSIONS	Overall , improvements were largest with tiotropium Respimat 5g .
BACKGROUND	ClinicalTrials.gov identifier NCT01233284 .

###24678979
BACKGROUND	Evolocumab , a monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) , significantly reduced low-density lipoprotein ( LDL ) cholesterol levels in phase 2 studies .
BACKGROUND	We conducted a phase 3 trial to evaluate the safety and efficacy of 52 weeks of treatment with evolocumab .
METHODS	We stratified patients with hyperlipidemia according to the risk categories outlined by the Adult Treatment Panel III of the National Cholesterol Education Program .
METHODS	On the basis of this classification , patients were started on background lipid-lowering therapy with diet alone or diet plus atorvastatin at a dose of 10 mg daily , atorvastatin at a dose of 80 mg daily , or atorvastatin at a dose of 80 mg daily plus ezetimibe at a dose of 10 mg daily , for a run-in period of 4 to 12 weeks .
METHODS	Patients with an LDL cholesterol level of 75 mg per deciliter ( 1.9 mmol per liter ) or higher were then randomly assigned in a 2:1 ratio to receive either evolocumab ( 420 mg ) or placebo every 4 weeks .
METHODS	The primary end point was the percent change from baseline in LDL cholesterol , as measured by means of ultracentrifugation , at week 52 .
RESULTS	Among the 901 patients included in the primary analysis , the overall least-squares mean ( SE ) reduction in LDL cholesterol from baseline in the evolocumab group , taking into account the change in the placebo group , was 57.02.1 % ( P < 0.001 ) .
RESULTS	The mean reduction was 55.74.2 % among patients who underwent background therapy with diet alone , 61.62.6 % among those who received 10 mg of atorvastatin , 56.85.3 % among those who received 80 mg of atorvastatin , and 48.55.2 % among those who received a combination of 80 mg of atorvastatin and 10 mg of ezetimibe ( P < 0.001 for all comparisons ) .
RESULTS	Evolocumab treatment also significantly reduced levels of apolipoprotein B , non-high-density lipoprotein cholesterol , lipoprotein ( a ) , and triglycerides .
RESULTS	The most common adverse events were nasopharyngitis , upper respiratory tract infection , influenza , and back pain .
CONCLUSIONS	At 52 weeks , evolocumab added to diet alone , to low-dose atorvastatin , or to high-dose atorvastatin with or without ezetimibe significantly reduced LDL cholesterol levels in patients with a range of cardiovascular risks .
CONCLUSIONS	( Funded by Amgen ; DESCARTES ClinicalTrials.gov number , NCT01516879 . )

###25790742
OBJECTIVE	Endoscopic stents are placed for palliation of extrahepatic bile duct obstruction .
OBJECTIVE	Although self-expandable metal stents ( SEMS ) remain patent longer than plastic stents , they are more expensive .
OBJECTIVE	We aimed to evaluate which type of stent ( plastic , uncovered SEMS [ uSEMS ] , or partially covered SEMS [ pcSEMS ] ) is the most effective and we assessed costs .
METHODS	We performed a multicenter randomized trial in 219 patients at 18 hospitals in The Netherlands from February 2008 through February 2013 .
METHODS	Patients were assigned randomly for placement of a plastic stent ( n = 73 ) , uSEMS ( n = 75 ) , or pcSEMS ( n = 71 ) during endoscopic retrograde cholangiopancreatography .
METHODS	Patients were followed up for up to 1 year .
METHODS	Researchers were not blinded to groups .
METHODS	The main study end points included functional stent time and costs .
RESULTS	The mean functional stent times were 172 days for plastic stents , 288 days for uSEMS , and 299 days for pcSEMS ( P < .005 for uSEMS and pcSEMS vs plastic ) .
RESULTS	The initial placement of plastic stents ( 1042 or $ 1106 ) cost significantly less than placement of SEMS ( 1973 or $ 2094 ) ( P = .001 ) .
RESULTS	However , the total cost per patient at the end of the follow-up period did not differ significantly between plastic stents ( 7320 or $ 7770 ) and SEMS ( 6932 or $ 7356 ) ( P = .61 ) .
RESULTS	Furthermore , in patients with short survival times ( 3 mo ) or metastatic disease , the total cost per patient did not differ between plastic stents and SEMS .
RESULTS	No differences in costs were found between pcSEMS and uSEMS .
CONCLUSIONS	Although placement of SEMS ( uncovered or partially covered ) for palliation of extrahepatic bile duct obstruction initially is more expensive than placement of plastic stents , SEMS have longer functional time .
CONCLUSIONS	The total costs after 1 year do not differ significantly with stent type .
CONCLUSIONS	Dutch Clinical Trial Registration no : NTR1361 .

###24765679
OBJECTIVE	To determine whether ureteric stent extraction strings affect stent-related quality of life ( QoL ) or increase complications after ureteroscopy ( URS ) for stone disease .
METHODS	In all , 68 patients undergoing URS ( October 2011 to May 2013 ) for stone disease were randomised to receive a ureteric stent with or without an extraction string .
METHODS	Patients completed the Ureteric Stent Symptom Questionnaire ( USSQ ) on postoperative days 1 and 6 , and 6 weeks after stent removal .
METHODS	Pain was assessed at stent removal .
METHODS	Adverse events , including early stent removal , stent migration , retained stent , urinary tract infection ( UTI ) , emergency room ( ER ) visits and postoperative phone calls were monitored .
RESULTS	There was no difference in stent-related QoL as measured by the USSQ between those with and without a stent extraction string , pain at stent removal between those who pulled their stent independently vs those who underwent cystoscopy for stent removal , or in the rate of UTIs , ER visits or phone calls between groups .
RESULTS	Five patients ( four female , one male ) removed their stent early by inadvertently pulling the string ; none required replacement .
RESULTS	Patients without a string had a significantly longer period with the postoperative ureteric stent ( 10.6 vs 6.3 days , P < 0.001 ) .
RESULTS	One patient without a stent string retained her ureteric stent for 6 months , which was removed by cystoscopy without incident .
CONCLUSIONS	Ureteric stent extraction strings may offer several advantages without increasing stent-related urinary symptoms , complications , or postoperative morbidity .

###25186834
OBJECTIVE	Administration of a loading dose of a statin ( HMG-CoA reductase inhibitor ) prior to percutaneous coronary intervention ( PCI ) contributes to protection from myocardial ischemic-reperfusion injury .
OBJECTIVE	This trial was designed to investigate the effect and mechanism of loading-dose rosuvastatin therapy before PCI in patients with acute coronary syndrome .
METHODS	One hundred and forty-three patients with acute coronary syndrome were randomized to either the loading-dose ( rosuvastatin 40mg given 4h before PCI ) or conventional-dose ( rosuvastatin 10mg given 4h before PCI ) group .
METHODS	Blood samples were collected before and 0 , 24 , and 72h post-PCI for measurement of serum cardiac troponin-I ( cTnI ) , creatine kinase-MB ( CK-MB ) , superoxide dismutase ( SOD ) , reactive oxygen species ( ROS ) , and malondialdehyde ( MDA ) .
METHODS	Echocardiography and the major adverse cardiac/cerebrovascular events ( MACCE ) rate were followed up for 6months post-PCI .
RESULTS	Blood serum CK-MB and cTnI were significantly lower in the loading-dose group than in the conventional-dose group at 24 and 72h post-PCI [ CK-MB : 26.903.22 vs. 32.962.65 IU/L , P = 0.024 ; 10.794.65 vs. 15.185.39 IU/L , P = 0.021 .
RESULTS	cTnI : 0.0460.007 vs. 0.0550.002 ng/mL , P = 0.015 ; 0.0270.006 vs. 0.0410.006 ng/mL , P = 0.026 ] .
RESULTS	Echocardiography at 6months after PCI revealed significant improvement in cardiac function in the loading-dose group compared with the conventional-dose group ( P < 0.05 ) .
RESULTS	The MACCE rate at 6months after PCI in the loading-dose group was lower than in the conventional-dose group ( P = 0.0428 ) .
RESULTS	The levels of MDA and ROS were decreased and the SOD level was significantly higher in the loading-dose group than in the conventional-dose group at 0 , 24 , and 72h post-PCI ( P < 0.05 ) .
CONCLUSIONS	Administration of loading-dose rosuvastatin in patients with acute coronary syndrome prior to PCI exerts myocardial protection by inhibition of oxidative stress .

###24683680
BACKGROUND	The variability in habitual intakes of most components in the Philippine diet is unknown .
OBJECTIVE	To perform a quantitative evaluation of the traditional Philippine diet using data collected over an extended period of time .
OBJECTIVE	We sought to identify seasonal variations and within-subject components of variation in nutrient intake .
METHODS	A quantitative evaluation of the Philippine diet was conducted in convents in metropolitan Manila as part of an efficacy trial to examine biofortified rice as an approach to improve iron nutritional status .
METHODS	Weighed food intakes were conducted on 54 days in each of more than 300 religious sisters over 9 months in 10 convents .
METHODS	The sisters consumed their habitual diets except for the substitution of one variety of rice for another .
RESULTS	More than 40 % of calories were derived from rice , with protein from meat and fish comprising 18 % of calories .
RESULTS	There were significant variations in macronutrient and micronutrient intakes across seasons of the year , with more rice consumed in the wet season and more fruits , eggs , milk , and beverages consumed in the dry season .
RESULTS	The day-to-day within-subject variation ( CV ) in median intake was 23 % for energy , 31 % for protein , 42 % for iron , and 138 % for vitamin A.
CONCLUSIONS	These novel data show that traditional Filipino dietary patterns have substantial individual variation and are inadequate in certain micronutrients .
CONCLUSIONS	This quantitative evaluation of diet can provide a reference point for dietary adequacy .

###24745024
OBJECTIVE	To study whether the reinforced feedback in virtual environment ( RFVE ) is more effective than traditional rehabilitation ( TR ) for the treatment of upper limb motor function after stroke , regardless of stroke etiology ( i.e. , ischemic , hemorrhagic ) .
METHODS	Randomized controlled trial .
METHODS	Participants .
METHODS	Forty-four patients affected by stroke .
METHODS	Intervention .
METHODS	The patients were randomized into two groups : RFVE ( N = 23 ) and TR ( N = 21 ) , and stratified according to stroke etiology .
METHODS	The RFVE treatment consisted of multidirectional exercises providing augmented feedback provided by virtual reality , while in the TR treatment the same exercises were provided without augmented feedbacks .
METHODS	Outcome Measures .
METHODS	Fugl-Meyer upper extremity scale ( F-M UE ) , Functional Independence Measure scale ( FIM ) , and kinematics parameters ( speed , time , and peak ) .
RESULTS	The F-M UE ( P = 0.030 ) , FIM ( P = 0.021 ) , time ( P = 0.008 ) , and peak ( P = 0.018 ) , were significantly higher in the RFVE group after treatment , but not speed ( P = 0.140 ) .
RESULTS	The patients affected by hemorrhagic stroke significantly improved FIM ( P = 0.031 ) , time ( P = 0.011 ) , and peak ( P = 0.020 ) after treatment , whereas the patients affected by ischemic stroke improved significantly only speed ( P = 0.005 ) when treated by RFVE .
CONCLUSIONS	These results indicated that some poststroke patients may benefit from RFVE program for the recovery of upper limb motor function .
CONCLUSIONS	This trial is registered with NCT01955291 .

###24259042
OBJECTIVE	Differences in manifestation , treatment , and outcomes of acute heart failure between men and women have not been well studied .
OBJECTIVE	The objective of this analysis was to characterize differences in clinical presentation , and in-hospital and post-discharge outcomes between sexes in acute heart failure patients .
RESULTS	Clinical profiles , treatment characteristics , and outcomes were compared between sexes in 2033 patients hospitalized for acute heart failure and impaired renal function .
RESULTS	Women comprised 33 % of the study population and were older , had higher body mass index , LVEF , and systolic blood pressure , and a greater prevalence of diabetes .
RESULTS	At baseline , women showed signs and symptoms of congestion comparable with men , but more often had rales , orthopnoea , and worse renal function .
RESULTS	Women were less intensively diuresed , as indicated by lower oral and intravenous diuretic doses used , fewer dose increases , and less total weight loss during hospitalization .
RESULTS	Furthermore , hospitalization was slightly but significantly prolonged in women ( 11.04 7.8 vs. 10.65 8.86 days ; P = 0.024 ) .
RESULTS	Age-adjusted 180-day mortality was lower in women ( 15.8 % vs. 18.5 % , hazard ratio 0.74 ; 95 % confidence interval 0.59-0 .93 , P = 0.010 ) , but multivariable risk-adjusted mortality was similar in both sexes , mainly attributable to lower blood urea nitrogen , higher LVEF , and higher systolic blood pressure in women compared with men .
CONCLUSIONS	Women with acute heart failure present with a clinical profile different from that of men , with more hypertension , diabetes , and depression , and a preserved LVEF .
CONCLUSIONS	During hospitalization , they were less intensively diuresed .
CONCLUSIONS	Nevertheless , risk-adjusted 180-day outcome was similar between sexes .

###24934734
OBJECTIVE	The purpose of this study was to compare the efficacy of percutaneous aspiration thrombectomy ( PAT ) followed by standard anticoagulant therapy , with anticoagulation therapy alone , for the treatment of acute proximal lower extremity deep vein thrombosis .
METHODS	In this randomised , prospective study , 42 patients with acute proximal iliofemoral deep vein thrombosis documented via Doppler ultrasound examination , were separated into an interventional treatment group ( 16 males , 5 females , average age 51years ) and a medical treatment group ( 13 males , 8 females , average age 59years ) .
METHODS	In the interventional group , PAT with large-lumen 9-F diameter catheterisation was applied , after initiation of standard anticoagulant therapy .
METHODS	Balloon angioplasty ( n 19 ) and stent implementation ( n : 14 ) were used to treat patients with residual stenosis ( > 50 % ) after PAT .
METHODS	Prophylactic IVC filters were placed in two patients .
METHODS	The thrombus clearance status of the venous system was evaluated by venography .
METHODS	In both the medical and interventional groups , venous patency rates and clinical symptom scores were evaluated at months 1 , 3 , and 12 after treatment .
RESULTS	Deep venous systems became totally cleared of thrombi in 12 patients treated with PAT .
RESULTS	The venous patency rates in month 12 were 57.1 and 4.76 % in the interventional and medical treatment groups , respectively .
RESULTS	A statistically significant improvement was observed in clinical symptom scores of the interventional group ( PAT ) with or without stenting ( 4.230.51 before treatment ; 0.810.92 at month 12 ) compared with the medical treatment group ( 4.000.63 before treatment ; 2.430.67 at month 12 ) .
RESULTS	During follow-up , four patients in the medical treatment and one in the interventional group developed pulmonary embolisms .
CONCLUSIONS	For treatment of acute deep vein thrombosis , PAT with or without stenting is superior to anticoagulant therapy alone in terms of both ensuring venous patency and improving clinical symptoms .
CONCLUSIONS	PAT is a safe , inexpensive , and easily performed method of endovascular treatment with a low rate of major complications .
CONCLUSIONS	Our present findings and literature data suggest that PAT can be used as first-line treatment in proximal deep vein thrombosis patients , especially when thrombolytic treatment is contraindicated .

###24377219
OBJECTIVE	To explore a more optimal therapy for chronic prostatitis .
METHODS	Ninty cases of chronic prostitis were randomized into a warming-promoting needling and target penetrating needling method group ( WT group ) , a conventional acupuncture group ( CA group ) and a medication group ( M group ) , 30 cases in each one .
METHODS	The warming-promoting needling method was applied at Zhongji ( CV 3 ) , Guanyuan ( CV 4 ) , Qihai ( CV 6 ) , Daheng ( SP 15 ) , Qichong ( ST 30 ) in the WT group , the needling sensation was targeted towards the prostate , once daily ; in CA group , conventional acupuncture was applied at the same acupoints of WT group ; Qianliekang tablets was prescribed to the M group .
METHODS	For the 3 groups , 10 treatment made one session and 3 days as an interval , the efficacy was evaluated after 3 sessions .
RESULTS	All of the 3 methods were effective for chronic prostitis , the total effective rate in the WT group was 93.3 % ( 28/30 ) , which was superior to 73.3 % ( 22/30 , P < 0.05 ) in the CA group and 63.3 % ( 19/30 , P < 0.01 ) in the M group .
RESULTS	The curative rate in the WT group was 80.0 % ( 24/30 ) , which was superior to 46.6 % ( 14/30 ) in the CA group and 30.0 % ( 9/30 ) in the M group ( both P < 0.001 ) .
CONCLUSIONS	The warming-promoting needling and target penetrating needling method achieve superior efficacy on chronic prostatitis as compared with conventional acupuncture and Qianliekang tablets .

###25442065
BACKGROUND	In the American College of Surgeons National Surgical Quality Improvement Program ( ACS NSQIP ) , pancreatic fistula has not been monitored , although organ space infection ( OSI ) data are collected .
BACKGROUND	Therefore , the purpose of this analysis was to determine the relationship between ACS NSQIP organ space infection and pancreatic fistulas .
METHODS	From 2007 to 2011 , 976 pancreatic resection patients were monitored via ACS NSQIP at our institution .
METHODS	From this database , 250 patients were randomly chosen for further analysis .
METHODS	Four patients were excluded because they underwent total pancreatectomy .
METHODS	Data on OSI were gathered prospectively .
METHODS	Data on pancreatic fistulas and other intra-abdominal complications were determined retrospectively .
RESULTS	Organ space infections ( OSIs ) were documented in 22 patients ( 8.9 % ) .
RESULTS	Grades B ( n = 26 ) and C ( n = 5 ) pancreatic fistulas occurred in 31 patients ( 12.4 % ) ; grade A fistulas were observed in 38 patients ( 15.2 % ) .
RESULTS	Bile leaks and gastrointestinal ( GI ) anastomotic leaks each developed in 5 ( 2.0 % ) patients .
RESULTS	Only 17 of 31 grade B and C pancreatic fistulas ( 55 % ) , and none of 38 grade A fistulas were classified as OSIs in ACS NSQIP .
RESULTS	In addition , only 2 of 5 bile leaks ( 40 % ) and 2 of 5 GI anastomotic leaks ( 40 % ) were OSIs .
RESULTS	Moreover , 3 OSIs were due to bacterial peritonitis , a chyle leak , and an ischemic bowel .
CONCLUSIONS	This analysis suggests that the sensitivity ( 55 % ) and specificity ( 45 % ) of organ space infection ( OSI ) in ACS NSQIP are too low for OSI to be a surrogate for grade B and C pancreatic fistulas .
CONCLUSIONS	We concluded that procedure-specific variables will be required for ACS NSQIP to improve outcomes after pancreatectomy .

###24757227
OBJECTIVE	To evaluate feasibility , safety , and efficacy of overnight closed-loop insulin delivery in free-living youth with type 1 diabetes .
METHODS	Overnight closed loop was evaluated at home by 16 pump-treated adolescents with type 1 diabetes aged 12-18 years .
METHODS	Over a 3-week period , overnight insulin delivery was directed by a closed-loop system , and on another 3-week period sensor-augmented therapy was applied .
METHODS	The order of interventions was random .
METHODS	The primary end point was time when adjusted sensor glucose was between 3.9 and 8.0 mmol/L from 2300 to 0700 h.
RESULTS	Closed loop was constantly applied over at least 4 h on 269 nights ( 80 % ) ; sensor data were collected over at least 4 h on 282 control nights ( 84 % ) .
RESULTS	Closed loop increased time spent with glucose in target by a median 15 % ( interquartile range -9 to 43 ; P < 0.001 ) .
RESULTS	Mean overnight glucose was reduced by a mean 14 ( SD 58 ) mg/dL ( P < 0.001 ) .
RESULTS	Time when glucose was < 70 mg/dL was low in both groups , but nights with glucose < 63 mg/dL for at least 20 min were less frequent during closed loop ( 10 vs. 17 % ; P = 0.01 ) .
RESULTS	Despite lower total daily insulin doses by a median 2.3 ( interquartile range -4.7 to 9.3 ) units ( P = 0.009 ) , overall 24-h glucose was reduced by a mean 9 ( SD 41 ) mg/dL ( P = 0.006 ) during closed loop .
CONCLUSIONS	Unsupervised home use of overnight closed loop in adolescents with type 1 diabetes is safe and feasible .
CONCLUSIONS	Glucose control was improved during the day and night with fewer episodes of nocturnal hypoglycemia .

###24461499
OBJECTIVE	To evaluate the long-term outcomes of thin-flap laser in situ keratomileusis ( LASIK ) in eyes with thin corneas ( central corneal thickness [ CCT ] < 500 m ) but normal topography .
METHODS	Private center , Tokyo , Japan .
METHODS	Retrospective randomized comparative study .
METHODS	The efficacy , safety , predictability , and topography of LASIK were evaluated in eyes with a CCT of less than 500 m but with normal topography ( thin-cornea group ) to 6 years postoperatively .
METHODS	The LASIK outcomes in the thin-cornea group were compared with those in eyes with a CCT of 500 m or greater ( control group ) .
METHODS	Analysis was performed to determine whether there were differences between the groups at the last checkup 3 to 4 years postoperatively .
RESULTS	In the thin-cornea group ( 291 eyes ; 146 patients ) , no significant differences were observed in LASIK outcomes when eyes were subdivided by the time of final checkup ( 3 , 4 , and 5 years ) .
RESULTS	There was a significant difference in visual and refractive outcomes between 3 months postoperatively and the last checkup in the thin-cornea group and the control group ( 371 eyes ; 193 patients ) .
RESULTS	No significant difference in visual , refractive , or topography outcomes was observed between the 2 groups at the last checkup .
CONCLUSIONS	Laser in situ keratomileusis in eyes with thin corneas was as safe and effective as and showed similar long-term stability in eyes with a CCT of 500 m or greater .
CONCLUSIONS	No eye in either group had a postoperative complication .
BACKGROUND	No author has a financial or proprietary interest in any material or method mentioned .

###24548816
BACKGROUND	Skin-to-skin contact reduces pain response in preterm infants subjected to minor painful procedures , such as heel lance .
BACKGROUND	Diaper change is a procedure performed several times daily in hospitalized preterm infants .
BACKGROUND	Routine care giving tasks such as diaper change may be stressful for the infant .
OBJECTIVE	The purpose of this study was to investigate whether diaper change induces stress and if skin-to-skin contact could reduce such stress , measured by changes in skin conductance .
METHODS	This was a randomized crossover pilot study in 19 preterm infants with gestational age between 28 and 34 weeks .
METHODS	The diaper change procedure was done twice in each infant , once during skin-to-skin contact , and once in incubator or bed with the mother present .
METHODS	During diaper change heart rate ( HR ) , peripheral oxygen saturation ( SpO2 ) , and changes in skin conductance ( SC ) peaks per sec , using the Skin Conductance Algesimeter ( SCA ) , were registered .
RESULTS	The mean SC peaks/sec increased/decreased significantly under/after change of diapers which thereby underpins that this is a stressful procedure for the preterm infant .
RESULTS	Skin-to-skin contact ( SSC ) entails significantly lower stress levels ( p < 0.05 ) compared to diaper changed in an incubator/bed measured by the SCA .
CONCLUSIONS	Diaper change is a stressful procedure for preterm infants and may be ameliorated by skin-to-skin contact .

###24760745
BACKGROUND	This was a randomized clinical trial to determine whether Nordic pole walking ( NPW ) is more effective in improving walking distance than a standard home exercise programme ( HEP ) in patients with intermittent claudication .
METHODS	Fifty-two patients with stable claudication were allocated randomly to a standard HEP or NPW group , and asked to complete three 30-min walks per week for 12 weeks .
METHODS	Claudication distance ( CD ) and maximum walking distance ( MWD ) were measured at 0 ( baseline ) , 4 , 8 and 12 weeks .
METHODS	Patients in the NPW group were tested with ( NPW + ) and without ( NPW - ) poles .
RESULTS	For NPW + , CD increased immediately from a median ( range ) of 124 ( 71-248 ) m to 148 ( 116-426 ) m , and MWD from 248 ( 149-900 ) to 389 ( 194-1099 ) m ( P = 0.004 and P < 0.001 respectively ) .
RESULTS	By 12 weeks , CD had further increased to 199 ( 118-550 ) m and MWD had more than doubled to 538 ( 250-1750 ) m ( P < 0.001 and P = 0.001 ) .
RESULTS	For NPW - , CD at 12 weeks had increased significantly to 151 ( 100-328 ) m and MWD to 400 ( 200-900 ) m ( P < 0.001 and P = 0.006 respectively ) .
RESULTS	At 12 weeks the changes in the standard HEP group were not significant , despite excellent compliance : CD from 107 ( 56-332 ) to 153 ( 59-321 ) m and MWD from 355 ( 92-600 ) to 334 ( 149-874 ) m ( P = 0.030 and P = 0.260 respectively ) .
CONCLUSIONS	A 12-week exercise programme using Nordic poles significantly improved walking distance in claudicants compared with a standard HEP .
BACKGROUND	ISRCTN78168304 ( http://www.controlled-trials.com ) .

###26241263
OBJECTIVE	To evaluate whether an electronic health record ( EHR ) reminder improves rates of screening for type 2 diabetes in women with prior gestational diabetes .
METHODS	We randomly allocated primary care providers ( by clinic site ) to a reminder for type 2 diabetes screening within the EHR or to usual care .
METHODS	Women with previous gestational diabetes mellitus were identified through an automated search of laboratory results and the problem list .
METHODS	We compared rates of screening during the study period ( 2010-2012 ) in women at intervention sites with those at control sites .
METHODS	With a sample size of 850 participants , we had 80 % power to detect a 15 % difference in screening rates .
RESULTS	We included 847 individuals seen at a participating clinic during the study period , of whom 471 were at a reminder clinic and 376 were at a control clinic .
RESULTS	A similar proportion of women were screened for type 2 diabetes in both groups ( n = 265 , 56.3 % of the reminder group compared with n = 206 , 54.8 % of the control group , P = .67 ; adjusted odds ratio [ OR ] 1.04 , 95 % confidence interval [ CI ] 0.79-1 .38 ) .
RESULTS	Patient characteristics associated with risk for diabetes including body mass index ( adjusted OR per kg/m 1.05 , 95 % CI 1.01-1 .08 ) and race ( adjusted OR for nonwhite race 2.14 , 95 % CI 1.57-2 .92 ) were significantly associated with screening .
CONCLUSIONS	A simple EHR reminder did not increase the rate of diabetes screening in women with prior gestational diabetes mellitus .
BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT01288144 .
METHODS	I.

###24998111
OBJECTIVE	This is a prospective , randomized , single-blind study .
OBJECTIVE	We aimed to compare the tracheal intubation conditions and hemodynamic responses either remifentanil or a combination of remifentanil and lidocaine with sevoflurane induction in the absence of neuromuscular blocking agents .
METHODS	Fifty intellectually disabled , American Society of Anesthesiologists I-II patients who underwent tooth extraction under outpatient general anesthesia were included in this study .
METHODS	Patients were randomized to receive either 2 g kg ( -1 ) remifentanil ( Group 1 , n = 25 ) or a combination of 2 g kg ( -1 ) remifentanil and 1 mg kg ( -1 ) lidocaine ( Group 2 , n = 25 ) .
METHODS	To evaluate intubation conditions , Helbo-Hansen scoring system was used .
METHODS	In patients who scored 2 points or less in all scorings , intubation conditions were considered acceptable , however if any of the scores was greater than 2 , intubation conditions were regarded unacceptable .
METHODS	Mean arterial pressure , heart rate and peripheral oxygen saturation ( SpO2 ) were recorded at baseline , after opioid administration , before intubation , and at 1 , 3 , and 5 min after intubation .
RESULTS	Acceptable intubation parameters were achieved in 24 patients in Group 1 ( 96 % ) and in 23 patients in Group 2 ( 92 % ) .
RESULTS	In intra-group comparisons , the heart rate and mean arterial pressure values at all-time points in both groups showed a significant decrease compared to baseline values ( p = 0.000 ) CONCLUSION : By the addition of 2 g/kg remifentanil during sevoflurane induction , successful tracheal intubation can be accomplished without using muscle relaxants in intellectually disabled patients who undergo outpatient dental extraction .
RESULTS	Also worth noting , the addition of 1mg/kg lidocaine to 2 g/kg remifentanil does not provide any additional improvement in the intubation parameters .

###24814553
BACKGROUND	Global tuberculosis ( TB ) control may require mass vaccination with a new TB vaccine , such as a recombinant bacille Calmette Guerin ( BCG ) or attenuated Mycobacterium tuberculosis ( MTB ) .
BACKGROUND	The safety profile of live mycobacterial vaccines in latently infected adults with prior infant BCG vaccination is unknown .
OBJECTIVE	Evaluate safety and reactogenicity of BCG revaccination , with or without isoniazid ( INH ) pretreatment , in adults with latent MTB infection ( LTBI ) .
METHODS	Eighty-two healthy , HIV uninfected , South African adults , with a BCG scar and tuberculin skin test ( TST ) diameter 15 mm , were randomized to receive 6 months of INH , starting either before , or 6 months after , intradermal revaccination with BCG Vaccine SSI ( Statens Serum Institut , Copenhagen ) .
METHODS	Safety and reactogenicity data are reported through 3 months post BCG revaccination .
RESULTS	Baseline characteristics were similar between treatment arms .
RESULTS	Mean baseline TST diameter was 20 4 mm .
RESULTS	Seventy-two subjects received BCG revaccination .
RESULTS	Injection site erythema ( 68 % ) and induration ( 86 % ) peaked 1 week after revaccination .
RESULTS	Ulceration ( 76 % ) peaked at 2 weeks , and resolved by 3 months in all but 3 subjects .
RESULTS	Diameter of ulceration was > 10mm in only 8 % , but a residual scar was common ( 85 % ) .
RESULTS	No regional lymphadenitis or serious morbidity related to BCG was seen .
RESULTS	Reactogenicity was not affected by INH pretreatment .
CONCLUSIONS	BCG revaccination of MTB infected adults is safe , well tolerated , and reactogenicity is similar to that of primary BCG vaccination .
CONCLUSIONS	Clinical trials of live recombinant BCG or attenuated MTB vaccines may be considered in latently infected adults , with or without INH pretreatment ( ClinicalTrials.gov identifier : NCT01119521 ) .

###24309219
OBJECTIVE	Oral nonsteroidal antiinflammatory medications ( NSAIDs ) have been shown to reduce pain with first-trimester surgical abortion compared to placebo , but it is unclear if one NSAID is better than another .
OBJECTIVE	Some providers administer intramuscular ketorolac , though data regarding its efficacy in abortion are limited .
OBJECTIVE	This study was designed to compare oral ibuprofen to intramuscular ketorolac for pain management during first-trimester surgical abortion .
METHODS	This was a randomized , double-blind , controlled trial .
METHODS	Women undergoing first-trimester surgical abortion with local anesthesia were randomized to preprocedural oral ibuprofen , 800 mg given 60-90 min preprocedure , or intramuscular ketorolac , 60 mg given 30-60 min preprocedure .
METHODS	The primary outcome was pain with uterine aspiration on a 21-point , 0-100 , numerical rating scale .
METHODS	Secondary outcomes included pain with cervical dilation , postoperative pain and patient satisfaction .
RESULTS	Ninety-four women were enrolled ; 47 were randomized to ibuprofen and 47 to ketorolac .
RESULTS	The groups did not differ with regards to demographics , reproductive history or Depression Anxiety Stress Scale scores .
RESULTS	Mean pain scores for suction curettage did not differ between groups ( 52.3 vs. 56.2 , p = .53 ) .
RESULTS	There was also no difference in pain with cervical dilation ( 41.6 vs. 45.4 , p = 0.48 ) or postoperative pain ( 22.3 vs. 15.0 p = .076 ) , though patients in the ketorolac group experienced significantly greater arm pain than those who received a placebo injection ( 30.4 vs. 15.6 , p < .001 ) .
RESULTS	Satisfaction with pain control did not differ significantly by group .
CONCLUSIONS	Intramuscular ketorolac does not offer superior pain control compared to oral ibuprofen for first-trimester surgical abortion .
CONCLUSIONS	Intramuscular ketorolac does not offer superior pain control over oral ibuprofen during first-trimester surgical abortion , is more expensive and causes patients significant arm discomfort .
CONCLUSIONS	Its use should therefore be reserved for patients who can not tolerate oral NSAIDs .

###25263372
OBJECTIVE	To study the effect of urapidil combined with phentolamine in the management of hypertension during extracorporeal circulation .
METHODS	Ninety patients undergoing aortic and mitral valve replacement were randomly divided into 3 equal groups to receive treatment with phentolamine ( group A ) , urapidil ( group B ) , or both ( group C ) during extracorporeal circulation .
METHODS	The mean arterial pressure ( MAP ) before and after drug administration , time interval of two administrations , spontaneous recovery of heart beat after aorta unclamping , ventricular arrhythmia , changes of ST-segment 1 min after the recovery of heart beat , ante-parallel cycle time , aorta clamping time , post-parallel cycle time , dopamine dose after cardiac resuscitation , and perioperative changes of plasma TNF - and IL-6 levels were recorded .
RESULTS	There was no significant difference in MAP between the 3 groups before or after hypotensive drug administration ( P > 0.05 ) .
RESULTS	The time interval of two hypotensive drug administrations was longer in group C than in groups A and B ( P < 0.05 ) .
RESULTS	The incidence of spontaneous recovery of heart beat after aorta unclamping , incidence of ventricular arrhythmia , changes of ST-segment 1 min after the recovery of heart beat , ante-parallel cycle time , aorta clamping time , and post-parallel cycle time were all comparable between the 3 groups .
RESULTS	The dose of dopamine administered after cardiac resuscitation was significantly larger in group B than in groups A or group C ( P < 0.05 ) .
RESULTS	The plasma levels of TNF - and IL-6 were significantly increased after CPB and after the operation in all the groups , but were lowed in group C than in groups A and B at the end of CPB and at 2 h and 12 after the operation .
CONCLUSIONS	Urapidil combined with phentolamine can control hypertension during extracorporeal circulation without causing hypotension .

###24222836
OBJECTIVE	Eptifibatide is indicated during percutaneous coronary intervention ( PCI ) with continuation for 18-24 hours post procedure but is associated with bleeding .
OBJECTIVE	We examined the efficacy and safety of shorter post-PCI eptifibatide infusions in high-risk non-ST-segment elevation acute coronary syndrome ( NSTE ACS ) patients .
METHODS	EARLY ACS patients treated with PCI and eptifibatide were grouped by post-procedure infusion duration : < 10 , 10-13 , 13-17 , and 17-25 ( per protocol ) hours .
METHODS	Adjusted estimated event rates for 96-hour death/myocardial infarction ( MI ) / recurrent ischaemia requiring urgent revascularization ( RIUR ) , 30-day death/MI , post-PCI packed red blood cell ( PRBC ) transfusion , and GUSTO ( Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries ) moderate/severe bleeding were obtained using inverse-propensity weighting to account for informative censoring of infusions .
RESULTS	Among 3271 eptifibatide-treated PCI patients , there were 66 96-hour death/MI/RIUR events , 94 30-day death/MI events , 127 PRBC transfusions , and 115 GUSTO moderate/severe bleeds .
RESULTS	Compared with per protocol , patients receiving post-PCI infusions < 10 hours had similar adjusted estimated rates of 96-hour death/MI/RIUR ( absolute difference 0.021 higher ; 0.040 vs. 0.019 , 95 % CI -0.023 to 0.064 ; p = 0.35 ) and 30-day death/MI ( 0.020 higher ; 0.046 vs. 0.026 , 95 % CI -0.021 to 0.062 ; p = 0.34 ) .
RESULTS	There were also no differences in ischaemic outcomes between infusions of 10-17 hours and per-protocol infusions .
RESULTS	Adjusted estimated rates of PRBC transfusion were higher for the < 10-hour infusion group compared with per protocol ( 0.048 higher ; 0.079 vs. 0.031 , 95 % CI 0.005 to 0.091 , p = 0.03 ) but were similar for other groups .
RESULTS	Adjusted GUSTO moderate/severe bleeding rates were similar to per-protocol rates for all groups .
CONCLUSIONS	In high-risk NSTE ACS patients , post-PCI eptifibatide infusions < 18 hours were not associated with worse ischaemic outcomes .
CONCLUSIONS	Shorter eptifibatide infusions in this population may be feasible .

###24813598
OBJECTIVE	Residual anastomoses after fetoscopic laser surgery for twin-to-twin transfusion syndrome ( TTTS ) may lead to severe postoperative complications , including recurrent TTTS and twin anemia-polycythemia sequence ( TAPS ) .
OBJECTIVE	A novel technique ( Solomon technique ) using laser coagulation of the entire vascular equator was recently investigated in a randomized controlled trial ( Solomon trial ) and compared with the Standard selective laser technique .
OBJECTIVE	The aim of this secondary analysis was to evaluate the occurrence and characteristics of residual anastomoses in placentas included in the Solomon trial .
METHODS	International multicenter randomized controlled trial in TTTS , randomized 1:1 ratio to either the Solomon laser technique or Standard laser technique .
METHODS	At time of laser , surgeons recorded whether they considered the procedure to be complete .
METHODS	Placental dye injection was performed after birth in the participating centers to evaluate the presence of residual anastomoses .
RESULTS	A total of 151 placentas were included in the study .
RESULTS	The percentage of placentas with residual anastomoses in the Solomon group and Standard group was 19 % ( 14/74 ) and 34 % ( 26/77 ) , respectively ( P = .04 ) .
RESULTS	The percentage of placentas with residual anastomoses in the subgroup of cases where the procedure was recorded as complete was 8/65 ( 12 % ) and 22/69 ( 32 % ) in the Solomon group and Standard group , respectively ( P < .01 ) .
CONCLUSIONS	The Solomon laser technique reduces the risk of residual anastomoses .
CONCLUSIONS	However , careful follow-up remains essential also after the Solomon technique , as complete dichorionization is not always achieved .

###25399314
OBJECTIVE	Visual stimulation increases the blood flow in the posterior cerebral artery ( PCA ) , which supplies blood to the visual cortex by neurovascular coupling ( NVC ) .
OBJECTIVE	Relative contributions of vasodilatation and pressor response on NVC during dynamic exercise are still unknown .
METHODS	We measured the blood flow velocity in the PCA ( PCAv ) by transcranial Doppler ultrasound flowmetry during rest and exercise in 14 healthy males while they performed 12-min submaximal leg-cycle exercises at mild - , moderate - , and high-intensity , which corresponded to heart rates of 120 , 140 , and 160 bpm , respectively .
METHODS	NVC was estimated as the relative change in PCAv from 20 s eye-closing to the peak response during 40 s looking at a reversed checkerboard .
METHODS	Conductance index was calculated for evaluating vasodilatation as pressure divided by blood flow .
RESULTS	In response to visual stimulation , a magnitude of vasodilatation was significantly decreased under the moderate-intensity , while pressor response was significantly suppressed under the high-intensity exercises , compared with the control condition .
RESULTS	Conversely , peak response to visual stimulation in PCAv was not affected by exercise intensity though relative and absolute responses were significantly lower in the moderate - and high-intensity exercises than the control .
CONCLUSIONS	It is suggested that the contributions of pressor response and vasodilatation were modified by exercise intensity , partly playing a role for stabilizing the peak response of PCAv with visual stimulation during dynamic exercise .

###24499445
BACKGROUND	Chronic stable angina pectoris ( CSAP ) is a common cardiovascular condition that endangers a patient 's life quality and longevity .
BACKGROUND	As demonstrated in several clinical trials , acupuncture is attested to be effective for CSAP .
BACKGROUND	Current trials are not adequate enough to provide high-quality evidence for clinical decision making , as a result of inadequate methodology design and small sample size .
BACKGROUND	Notably , stark controversy toward acupoint specificity also exists in the clinical acupuncture trials for CSAP .
BACKGROUND	Therefore , we designed the present study as a randomized controlled trial primarily to investigate the effectiveness of acupuncture in addition to routine care among patients with CSAP .
BACKGROUND	Meanwhile , we examined whether acupoint on the disease-affected meridian ( DAM ) is superior to either acupoint on the non-affected meridian ( NAM ) or non-acupoint ( NA ) , to further investigate the meridian-based characteristics of acupoint specificity .
METHODS	This study was a multicenter , assessor and statistician blinded , randomized controlled trial in China .
METHODS	In this study , 404 participants in sum will be randomly assigned to four groups through central randomization in a 1:1:1:1 ratio .
METHODS	The whole study period is 20 weeks including a 4-week baseline period , a 4-week treatment period and a 12-week follow-up .
METHODS	Participants in the DAM group receive acupuncture stimulation at acupoints on the disease-affected meridian , and three different control groups will undergo acupuncture stimulation at the NAM , the non-acupoint and no intervention respectively , in addition to basic treatment .
METHODS	Participants in the acupuncture groups will receive 12 sessions of acupuncture treatment over 4 weeks , while the wait-listed ( WL ) group would receive free acupuncture treatment after the completion of the study .
METHODS	The outcome measures in this trial include the frequency of angina attack during 4 weeks as the primary outcome and eight other secondary outcomes .
CONCLUSIONS	This trial will provide new and relatively high-quality evidence in acupuncture treatment for CSAP .
CONCLUSIONS	Moreover , this trial may further validate the meridian-based characteristics of acupoint specificity by comparing the strength of acupoints on the disease-affected meridian versus that of the non-affected meridian , to further inspire optimization of acupuncture therapy for CSAP .
BACKGROUND	Clinical Trials.gov NCT01686230 .

###25202937
METHODS	A pragmatic , randomized , controlled , single-blinded trial in Dutch general practice .
OBJECTIVE	Assessing the costs and cost-effectiveness of adding segmental epidural steroid injections to care as usual in radiculopathy in general practice .
BACKGROUND	Lumbosacral radicular syndrome ( radiculopathy ) is a benign , generally self-limiting but painful condition caused by a herniated lumbar intervertebral disc , which results in an inflammatory process around the nerve root .
BACKGROUND	Segmental epidural steroid injections could lessen pain .
BACKGROUND	Low back pain and sciatica form a large financial burden on national health care systems .
BACKGROUND	Improving pain treatment could lower costs to society by diminishing loss of productivity .
METHODS	Patients with acute radiculopathy were included by general practitioners .
METHODS	All patients received usual care .
METHODS	Patients in the intervention group received one segmental epidural steroid injection containing 80 mg of triamcinolone as well .
METHODS	Follow-up was performed using postal questionnaires at 2 , 4 , 6 , 13 , 26 , and 52 weeks .
METHODS	Main outcomes were pain , disability and costs .
METHODS	Economic evaluation was performed from a societal perspective with a time horizon of 1 year .
RESULTS	Sixty-three patients were included in the analysis .
RESULTS	Mean total costs were 4414 or $ 5985 in the intervention group and 5121 or $ 6943 in the control group .
RESULTS	This difference was mostly due to loss of productivity .
RESULTS	The point estimate for the incremental cost-effectiveness ratio was -730 or - $ 990 ( 1-point diminishment on the numerical rating scale back pain score in 1 patient in the course of 1 yr would save 730 or $ 990 ) .
RESULTS	Bootstrapping showed a 95 % confidence interval of -4476 to 951 or - $ 6068 to $ 1289 .
RESULTS	The cost-effectiveness acceptability curve showed that without additional investment the probability that epidural steroids are cost-effective is more than 80 % .
CONCLUSIONS	The effect on pain and disability of epidural steroids in lumbosacral radicular syndrome is small but significant , and at lower costs with no reported complications or adverse effects .
CONCLUSIONS	Segmental epidural steroid injections could be considered by policy makers as an additional treatment option .

###24850615
BACKGROUND	We studied whether a 6-month group-mediated cognitive behavioral ( GMCB ) intervention for peripheral artery disease ( PAD ) participants , which promoted home-based walking exercise , improved 6-minute walk and other outcomes at 12-month follow-up , 6 months after completing the intervention , compared to a control group .
RESULTS	We randomized PAD participants to a GMCB intervention or a control group .
RESULTS	During phase I ( months 1 to 6 ) , the intervention used group support and self-regulatory skills during weekly on-site meetings to help participants adhere to home-based exercise .
RESULTS	The control group received weekly on-site lectures on topics unrelated to exercise .
RESULTS	Primary outcomes were measured at the end of phase I.
RESULTS	During phase II ( months 7 to 12 ) , each group received telephone contact .
RESULTS	Compared to controls , participants randomized to the intervention increased their 6-minute walk distance from baseline to 12-month follow-up , ( from 355.4 to 381.9 m in the intervention versus 353.1 to 345.6 m in the control group ; mean difference = +34.1 m ; 95 % confidence interval [ CI ] = +14.6 , +53.5 ; P < 0.001 ) and their Walking Impairment Questionnaire ( WIQ ) speed score ( from 36.1 to 46.5 in the intervention group versus 34.9 to 36.5 in the control group ; mean difference = +8.8 ; 95 % CI = +1.6 , +16.1 ; P = 0.018 ) .
RESULTS	Change in the WIQ distance score was not different between the 2 groups at 12-month follow-up ( P = 0.139 ) .
CONCLUSIONS	A weekly on-site GMCB intervention that promoted home-based walking exercise intervention for people with PAD demonstrated continued benefit at 12-month follow-up , 6 months after the GMCB intervention was completed .
BACKGROUND	ClinicalTrials.gov .
BACKGROUND	Unique identifier : NCT00693940 .

###24363523
OBJECTIVE	To evaluate the use of the Roux loop on the postoperative course in patients submitted for gastroenteroanastomosis ( GE ) .
METHODS	Non-jaundiced patients ( n = 41 ) operated on in the Department of General and Transplant Surgery in Lodz , between January 2010 and December 2011 were enrolled .
METHODS	The tumor was considered unresectable when liver metastases or major vascular involvement were confirmed .
METHODS	Patients were randomized to receive Roux ( n = 21 ) or conventional GE ( n = 20 ) on a prophylactic basis .
RESULTS	The mean time to nasogastric tube withdrawal in Roux GE group was shorter ( 1.4 0.75 vs 2.8 1.1 , P < 0.001 ) .
RESULTS	Time to starting oral liquids , soft diet and regular diet were decreased ( 2.3 0.86 vs 3.45 1.19 ; P < 0.001 ; 3.3 0.73 vs 4.4 1.23 , P < 0.001 and 4.5 0.76 vs 5.6 1.42 , P = 0.002 ; respectively ) .
RESULTS	The Roux GE group had a lower use of prokinetics ( 10 mg thrice daily for 2.2 1.8 d vs 3.7 2.6 d , P = 0.044 ; total 62 49 mg vs 111 79 mg , P = 0.025 ) .
RESULTS	The mean hospitalization time following Roux GE was shorter ( 7.7 d vs 9.6 d , P = 0.006 ) .
RESULTS	Delayed gastric emptying ( DGE ) was confirmed in 20 % after conventional GE but in none of the patients following Roux GE .
CONCLUSIONS	Roux gastrojejunostomy during open abdomen exploration in patients with unresectable pancreatic cancer is easy to perform , decreases the incidence of DGE and lowers hospitalization time .

###24797222
OBJECTIVE	In the Mexican-American population , the prevalence of Type 2 diabetes mellitus ( T2DM ) is as high as 50 % of the population .
OBJECTIVE	This randomized controlled clinical trial was designed to elucidate how treatment of periodontal disease affects HbA1c values in this population .
METHODS	One hundred and fifty-four T2DM patients with periodontal disease were enrolled in the study .
METHODS	The test group was treated with scaling and root planing ( SRP ) ; the control group received oral hygiene instructions .
METHODS	At baseline and 4-6 weeks after therapy , a complete periodontal examination was performed .
METHODS	Blood was collected at baseline and 4 months later for HbA1c levels .
RESULTS	One hundred and twenty-six individuals completed the study .
RESULTS	Baseline mean SD HbA1c for the test and control groups were 9.0 2.3 % and 8.4 2.0 % respectively .
RESULTS	Non-significant difference in HbA1c reductions ( 0.6 2.1 % and 0.3 1.7 % ) was found between test and control groups at 4 months .
RESULTS	Comparisons of the periodontal clinical parameters between the test and control groups found significant differences with improved results in the test subjects .
CONCLUSIONS	No statistically significant differences were found in the changes of HbA1c levels between test and control groups .
CONCLUSIONS	Non-surgical periodontal therapy improved the magnitude of change in periodontal parameters as compared to the control subjects .
CONCLUSIONS	ClinicalTrials.gov Identifier : NCT01128374 .

###24407777
OBJECTIVE	The study aimed at comparing the fixed tapering dose and the symptom-triggered regimens of lorazepam for alcohol detoxification .
METHODS	We carried out a prospective , randomized , double blind controlled trial involving 63 consecutive consenting male patients admitted with diagnosis of uncomplicated alcohol withdrawal .
METHODS	The patients were randomized into two groups based on the type of lorazepam dosage : symptom-triggered ( n = 33 ) and fixed tapering dose regimens ( n = 30 ) .
METHODS	Alcohol withdrawal symptoms were rated on CIWA-Ar ( Clinical Institute Withdrawal Assessment - Alcohol revised ) .
METHODS	The main outcome measures were the total amount and duration of lorazepam treatment and the incidence of adverse events or complications .
RESULTS	The mean lorazepam dose administered in the symptom-triggered group was significantly lower than in the fixed tapering dose group ( 9.5 versus 19.9 mg , P < 0.001 ) and for a significantly shorter duration of time ( 47.8 versus 146 h , P < 0.001 ) with more significant results for higher initial CIWA-Ar scores .
RESULTS	There were no significant differences between both the groups in terms of the incidence of complications like seizures or delirium tremens .
CONCLUSIONS	Symptom-triggered lorazepam treatment for alcohol withdrawal resulted in administration of lower total doses of medication for a shorter duration of treatment and was as safe as the fixed tapering dose .

###25897047
BACKGROUND	Peripheral intravenous catheterization in children is challenging , and success rates vary greatly .
BACKGROUND	We conducted a pragmatic randomized controlled trial to determine whether the use of ultrasound or near-infrared vascular imaging to guide catheterization would be more effective than the standard approach in achieving successful catheter placement on the first attempt .
METHODS	We enrolled a convenience sample of 418 children in a pediatric emergency department who required peripheral intravenous catheterization between June 2010 to August 2012 .
METHODS	We stratified them by age ( 3 yr and > 3 yr ) and randomly assigned them to undergo the procedure with the standard approach , or with the help of either ultrasound or near-infrared vascular imaging .
METHODS	The primary outcome was the proportion of patients who had successful placement of a catheter on the first attempt .
RESULTS	The rate of successful first attempts did not differ significantly between either of the 2 intervention groups and the standard approach group ( differences in proportions -3.9 % , 95 % confidence interval [ CI ] -14.2 % to 6.5 % , for ultrasound imaging ; -8.7 % , 95 % CI -19.4 % to 1.9 % , for near-infrared imaging ) .
RESULTS	Among children 3 years and younger , the difference in success rates relative to standard care was also not significant for ultrasound imaging ( -9.6 % , 95 % CI -29.8 % to 10.6 % ) , but it was significantly worse for near-infrared imaging ( -20.1 % , 95 % CI -40.1 % to -0.2 % ) .
RESULTS	Among children older than 3 years , the differences in success rates relative to standard care were smaller but not significant ( -2.3 % , 95 % CI -13.6 % to 9.0 % , for ultrasound imaging ; -4.1 % , 95 % CI -15.7 % to 7.5 % , for near-infrared imaging ) .
RESULTS	None of the pairwise comparisons were statistically significant in any of the outcomes .
CONCLUSIONS	Neither technology improved first-attempt success rates of peripheral intravenous catheterization in children , even in the younger group .
CONCLUSIONS	These findings do not support investment in these technologies for routine peripheral intravenous catheterization in children .
BACKGROUND	ClinicalTrials.gov , no .
BACKGROUND	NCT01133652 .

###24601050
BACKGROUND	The aim of this survey was to compare the effect of letrozole with medroxyprogesterone acetate ( MPA ) in treatment of simple endometrial hyperplasia to preserve fertility in young women .
METHODS	Forty-five patients referred to Shahid Sadoughi gynecology clinics from 2009 until 2011 who suffered from abnormal vaginal bleeding or endometrial thickness , that underwent curettage with diagnosis of simple endometrial hyperplasia without atypia were enrolled .
METHODS	The patients were divided randomly into two groups .
METHODS	First group including 22 women receive ten mg MPA , for ten days during a month for three months .
METHODS	All cases were followed by interview , endometrial curetage , and vaginal sonography .
METHODS	Serum level of estradiol was checked before and after treatment .
METHODS	At the end of the study , biopsy was retaken in 41 patients .
METHODS	All the patients were under observation by two gynecologists .
RESULTS	Age range of patients was 20 to 42 years .
RESULTS	Mean body mass index ( BMI ) in the MPA and letrozole groups was 29.13 + / - 4.8 and 25.42 + / - 4.2 , respectively .
RESULTS	Fifty and 34.8 percent of cases had history of obesity or polycystic ovarian syndrome ( PCOS ) in MPA and letrozole groups , respectively .
RESULTS	Forty-one selected cases ( 20 of the MPA and 21 of the letrozole groups ) continued the treatment for three months .
RESULTS	The endometrial thicknesses decreased in both groups .
RESULTS	Serum estradiol level also decreased in both groups .
RESULTS	The most common complication in the MPA and letrozole groups was headache ( 27.3 % ) and flashing and dizziness , respectively .
RESULTS	The side-effects were reported less in the letrozole group and the most common ones in this group were dizziness and flashing .
CONCLUSIONS	In women suffering from simple endometrial hyperplasia without atypia , letrozole can lead to decrease of serum estradiol level and endometrial thickness like MPA .
CONCLUSIONS	In both groups , there was no simple hyperplasia report in curettage report following treatment .
CONCLUSIONS	It should be noted that there was an incomplete response to treat case with pathology of disordered proliferative type .
CONCLUSIONS	Letrozole is a good therapeutic option in simple endometrial hyperplasia without atypia : cases candidate for medical treatment .
CONCLUSIONS	To confirm the effect and safety of letrozole , more studies with larger samples are recommended .

###25064627
BACKGROUND	Obstructive Sleep Apnea ( OSA ) is a common medical problem in adults that is becoming increasingly recognized in children .
BACKGROUND	It occurs in the pediatric age group , from newborns to teens .
BACKGROUND	More recently , many specialists have estimated OSA prevalence to be between 5 and 6 % .
BACKGROUND	However , in syndromic children , the prevalence of OSA can be from 50 to 100 % , having a significant effect on their Quality-of-Life .
BACKGROUND	As they are a challenging population for management , it is essential to evaluate them thoroughly before planning appropriate intervention .
OBJECTIVE	To compare the efficacy of Adenotonsillectomy ( T&A ) and Continuous Positive Airway Pressure ( CPAP ) in syndromic children [ Down syndrome ( DS ) and Mucopolysaccharidoses ( MPS ) ] with Obstructive Sleep Apnea ( OSA ) .
METHODS	In a prospective , randomized , cohort comparative study , 124 syndromic children ( DS and MPS ) aged between 6 and 12 years were recruited from a private MPS support group and the Down Syndrome Society , Chennai .
METHODS	A standard assessment was performed on all children who entered the study including a full overnight Polysomnogram ( PSG ) , Epworth Sleepiness Scale-Children ( ESS-C ) and Quality-of-Life ( QOL ) tool OSA-18 .
METHODS	The children with positive PSG who consented for the study ( n = 80 ) were randomly distributed to two groups , T&A group & CPAP group .
METHODS	The children were followed up with repeat PSG , clinical evaluation , ESS-C and Quality-of-Life ( QOL ) tool OSA-18 for a period of 1 year .
RESULTS	Follow-up was available for 73 syndromic children .
RESULTS	Both the groups , T&A group and CPAP group , showed statistically significant ( p < 0.05 ) improvement in Apnea-Hypoapnea Index ( AHI ) , ESS-C , QOL from the intervention .
RESULTS	In our study , T&A showed equal outcome compared to CPAP .
RESULTS	The contrasting feature between the two groups was that CPAP use gave immediate sustained improvement while T&A gave gradual progressive improvement of symptoms over a period of 1 year .
CONCLUSIONS	On average , T&A gives equal outcomes as CPAP and it can be suggested as a first-line treatment in this group of syndromic children .

###24756487
BACKGROUND	During laparoscopic cholecystectomy ( LCHE ) , the insufflation with warmed and humidified carbon dioxide ( CO2 ) may reduce postoperative pain .
BACKGROUND	The aim of the study was to evaluate the positive effects of heated and humidified carbon dioxide gas on patients with regard to postoperative pain after LCHE .
METHODS	This is a prospective , randomized , double-blinded , controlled clinical trial .
METHODS	148 patients ( female = 98 , male = 50 ) scheduled for elective LCHE were randomized into two groups : receiving either heated humidified carbon dioxide , or standard gas .
METHODS	Intraoperative core temperature was measured .
METHODS	The perioperative management was identical for both groups .
METHODS	Postoperative pain intensity was assessed using a visual analog pain scale , and the amount of analgesic consumption was recorded .
METHODS	The postoperative pain management was also standardized and equal for both groups .
RESULTS	67 out of 148 received standard gas ( group A ) , and 81 received warmed , humidified gas ( group B ) .
RESULTS	The groups were comparable demographically .
RESULTS	The amount of analgesic consumption was recorded .
RESULTS	Intraoperative core temperature was significant higher in group B than in group A. Pain was significantly less in group B ( p = 0.025 ) 6h postoperatively .
RESULTS	On the first postoperative day , no significant difference in pain between the two groups was detectable ( p = 0.437 ) .
CONCLUSIONS	The use of warmed and humidified carbon dioxide during LCHE reduces postoperative pain at the day of operation .

###24290078
BACKGROUND	Existing theories suggest that the mother-infant relationship has a potentially significant effect on long-term adult mental health , but there are few empirical data to support this view .
BACKGROUND	Even fewer prior studies have examined the specific dynamics of the mother-infant relationship and their association with adult mental health .
METHODS	A total of 1752 inner-city infants born between 1960 and 1965 were followed prospectively as a part of the Collaborative Perinatal Project ( CPP ) and the Johns Hopkins Pathways to Adulthood Study .
METHODS	Multiple observations of development and an extensive adult interview were performed .
METHODS	Maternal behavior was observed and systematically rated at the infant 's 4-month pediatric neurological evaluation and at 8 months by a developmental psychologist .
METHODS	Factor analysis was used to organize the maternal behavior variables into different types of dysfunctional mother-infant relationships .
METHODS	Adult mental health was assessed at the follow-up interview , when the infant had reached the age of 27-33 years , by the General Health Questionnaire ( GHQ ) and self-perception of current mental health .
RESULTS	There was a significant association between unsupportive maternal behavior at 8 months and subsequent poor adult mental health ( Fisher 's exact test , p = 0.026 ) .
RESULTS	There was no association between overly involved maternal behavior and poor mental health as an adult .
RESULTS	After adjustment for potential confounding variables , the elevated rates of poor adult mental health in children of mothers who exhibited unsupportive maternal behavior at 8 months persisted ( OR = 1.41 [ 95 % CI = 1.00-1 .97 ] , p < 0.05 ) .
CONCLUSIONS	Infants who experience unsupportive maternal behavior at 8 months have an increased risk for developing psychological sequelae later in life .

###25141218
BACKGROUND	Low back pain is a common , highly debilitating condition , whose severity is variable .
BACKGROUND	This study evaluated the efficacy of treatment with Ga-Al-As diode laser ( 980nm ) with a large diameter spot ( 32cm ( 2 ) ) , in association with exercise therapy , in reducing pain .
OBJECTIVE	The present study aimed to evaluate the pain reduction efficacy of treatment with the Ga-Al-As diode laser ( 980nm ) in combination with exercise therapy , in patients with chronic low back pain ( CLBP ) .
METHODS	This study evaluated 100 patients with CLBP ( mean age 60 years ) who were randomly assigned to two groups .
METHODS	The laser plus exercises group ( Laser + EX : 50 patients ) received low-level laser therapy ( LLLT ) with a diode laser , 980nm , with a specific handpiece [ 32cm ( 2 ) irradiation spot size , power 20W in continuous wave ( CW ) , fluence 37.5 J/cm ( 2 ) , total energy per point 1200J ] thrice weekly , and followed a daily exercise schedule for 3 weeks ( 5 days/week ) .
METHODS	The exercises group ( EX : 50 patients ) received placebo laser therapy plus daily exercises .
METHODS	The outcome was evaluated on the visual analogue pain scale ( VAS ) , before and after treatment .
RESULTS	At the end of the 3 week period , the Laser + EX group showed a significantly greater decrease in pain than did the EX group .
RESULTS	There was a significant difference between the two groups , with average VAS scores of 3.96 ( Laser + EX group ) and 2.23 ( EX group ) .
RESULTS	The Student 's t test demonstrated a statistically significant difference between the two groups , at p < 0.001 .
CONCLUSIONS	This study demonstrated that the use of diode laser ( 980nm ) with large diameter spot size , in association with exercise therapy , appears to be effective .
CONCLUSIONS	Such treatment might be considered a valid therapeutic option within rehabilitation programs for nonspecific CLBP .

###24935999
BACKGROUND	Caffeine use is on the rise among children and adolescents .
BACKGROUND	Previous studies from our laboratory reported gender differences in the effects of caffeine in adolescents .
BACKGROUND	The purpose of this study was to test the hypotheses that gender differences in cardiovascular responses to caffeine emerge after puberty and that cardiovascular responses to caffeine differ across the phases of the menstrual cycle .
METHODS	To test these hypotheses , we examined heart rate and blood pressure before and after administration of placebo and 2 doses of caffeine ( 1 and 2 mg/kg ) in prepubertal ( 8 - to 9-year-olds ; n = 52 ) and postpubertal ( 15 - to 17-year-olds ; n = 49 ) boys ( n = 54 ) and girls ( n = 47 ) by using a double-blind , placebo-controlled , dose-response design .
RESULTS	There was an interaction between gender and caffeine dose , with boys having a greater response to caffeine than girls .
RESULTS	In addition , we found interactions between pubertal phase , gender , and caffeine dose , with gender differences present in postpubertal , but not in prepubertal , participants .
RESULTS	Finally , we found differences in responses to caffeine across the menstrual cycle in post-pubertal girls , with decreases in heart rate greater in the midluteal phase and blood pressure increases greater in the midfollicular phase of the menstrual cycle .
CONCLUSIONS	These data suggest that gender differences in response to caffeine emerge after puberty .
CONCLUSIONS	Future research will determine the extent to which these gender differences are mediated by physiological factors , such as steroid hormones , or psychosocial factors , such as more autonomy and control over beverage purchases .

###25138765
OBJECTIVE	To assess the efficacy and safety of oral azithromycin compared with oral doxycycline in patients with meibomian gland dysfunction ( MGD ) who had failed to respond to prior conservative management .
METHODS	110 patients ( > 12years old ) with MGD were randomly assigned to receive either oral 5-day azithromycin ( 500mg on day 1 and then 250mg/day ) or 1-month doxycycline ( 200mg/day ) .
METHODS	They also continued eyelid warming/cleaning and artificial tears .
METHODS	A score comprising five symptoms and seven signs ( primary outcome ) was recorded prior to treatment and at 1week , and 1 and 2months after treatment .
METHODS	Total score was the sum of both scores at each follow-up .
METHODS	Side effects were recorded and overall clinical improvement was categorised as excellent , good , fair or poor based on the percentage of change in the total score .
RESULTS	Symptoms and signs improved significantly in both groups ( p = 0.001 ) .
RESULTS	While improvement of symptoms was not different between the groups , bulbar conjunctival redness ( p = 0.004 ) and ocular surface staining ( p = 0.01 ) were significantly better in the azithromycin group .
RESULTS	The azithromycin group showed a significantly better overall clinical response ( p = 0.01 ) .
RESULTS	Mild gastrointestinal side effects were not significantly different between the groups except for the second visit , when the doxycycline group had significantly more side effects ( p = 0.002 ) .
CONCLUSIONS	Although both oral azithromycin and doxycycline improved the symptoms of MGD , 5-day oral azithromycin is recommended for its better effect on improving the signs , better overall clinical response and shorter duration of treatment .
BACKGROUND	NCT01783860 .

###24996416
BACKGROUND	The novel arthritis-specific Work Productivity Survey ( WPS ) was developed to estimate patient productivity limitations associated with arthritis within and outside the home , which is an unmet need in psoriatic arthritis ( PsA ) .
BACKGROUND	The WPS has been validated in rheumatoid arthritis .
BACKGROUND	This report assesses the discriminant validity , responsiveness and reliability of the WPS in adult-onset PsA .
METHODS	Psychometric properties were assessed using data from the RAPID-PsA trial ( NCT01087788 ) investigating certolizumab pegol ( CZP ) efficacy and safety in PsA .
METHODS	WPS was completed at baseline and every 4 weeks until Week 24 .
METHODS	Validity was evaluated at baseline via known-groups defined using first and third quartiles of patients ' Disease Activity Score 28 based on C-reactive protein ( DAS28 ( CRP ) ) , Health Assessment Questionnaire-Disability Index ( HAQ-DI ) , Short Form-36 ( SF-36 ) items and PsA Quality of Life ( PsAQoL ) scores .
METHODS	Responsiveness and reliability were assessed by comparing WPS mean changes at Week 12 in American College of Rheumatology 20 % improvement criteria ( ACR20 ) or HAQ-DI Minimal Clinically Important Difference ( MCID ) 0.3 responders versus non-responders , as well as using standardized response means ( SRM ) .
METHODS	All comparisons were conducted on the observed cases in the Randomized Set , regardless of the randomization group , using a non-parametric bootstrap-t method .
RESULTS	Compared with patients with a better health state , patients with a worse health state had on average 2 to 6 times more household work days lost , more days with reduced household productivity , more days missed of family/social/leisure activities , more days with outside help hired and a significantly higher interference of arthritis per month .
RESULTS	Among employed patients , those with a worse health state had 2 to 4 times more workplace days lost , more days with patient workplace productivity reduced , and a significantly higher interference of arthritis on patient workplace productivity versus patients with a better health state .
RESULTS	WPS was also responsive to clinical changes , with responders having significantly larger improvements at Week 12 in WPS scores versus non-responders .
RESULTS	The effect sizes for changes in productivity in ACR20 or HAQ-DI MCID responders were moderate ( 0.5 < SRM < 0.8 ) or small .
CONCLUSIONS	These analyses demonstrate the validity , responsiveness and reliability of the WPS , as an instrument for the measurement of patient productivity within and outside the home in an adult-onset PsA population .

###25498130
OBJECTIVE	Insulin degludec/insulin aspart ( IDegAsp ) is a soluble co-formulation of IDeg and IAsp .
OBJECTIVE	This pan-Asian , 26-week trial investigated efficacy and safety of IDegAsp vs biphasic insulin aspart 30 ( BIAsp 30 ) in Asian adults with type 2 diabetes ( T2DM ) , inadequately controlled on once - or twice-daily ( BID ) basal , premixed or self-mixed insulin .
METHODS	Participants ( mean age 59.8 years , HbA1c 8.4 % , FPG 7.9 mmol/L , BMI 25.4 kg/m ( 2 ) ) were randomised 2:1 to BID IDegAsp ( n = 282 ) or BIAsp 30 ( n = 142 ) and continued existing metformin treatment .
METHODS	Insulins were administered with breakfast and main evening meal , titrated to a pre-breakfast and pre-main evening meal self-measured plasma glucose target of 4-5 mmol/L .
RESULTS	IDegAsp achieved the primary endpoint of non-inferiority to BIAsp 30 for mean change in HbAc ( estimated treatment difference [ ETD ] IDegAsp-BIAsp 30 : 0.05 % points [ 95 % CI -0.10 ; 0.20 ] ) .
RESULTS	IDegAsp was superior in lowering fasting plasma glucose ( FPG ) ( ETD -1.06 mmol/L , 95 % CI -1.43 ; -0.70 , p < 0.001 ) , and resulted in a lower final mean daily insulin dose ( 0.79 U/kg vs 0.99 U/kg , estimated rate ratio [ RR ] 0.79 , 95 % CI 0.73 ; 0.85 , p < 0.0001 ) .
RESULTS	Rates of overall confirmed and severe hypoglycaemia were similar between treatments , while rate of nocturnal confirmed hypoglycaemia was numerically ( p = ns ) lower with IDegAsp .
RESULTS	During the maintenance period there was a trend ( p = ns ) towards lower hypoglycaemia rates for IDegAsp .
CONCLUSIONS	In Asian adults with T2DM , IDegAsp BID effectively improves long-term glycaemic control , and compared to BIAsp 30 , provides superior reductions in FPG with a lower dose , and numerically less nocturnal hypoglycaemia .

###24422912
BACKGROUND	While neuromodulation through unihemispheric repetitive transcranial magnetic stimulation ( rTMS ) has shown promise for the motor recovery of stroke patients , the effectiveness of the coupling of different rTMS protocols remains unclear .
OBJECTIVE	We aimed to test the long-term efficacy of this strategy with different applying sequences and to identify the electrophysiological correlates of motor improvements to the paretic hand .
RESULTS	In our sham-controlled , double-blinded parallel study , 48 stroke patients ( 2-6 months poststroke ) were randomly allocated to three groups .
RESULTS	Group A underwent 20-session rTMS conditioning initiated with 10-session 1 Hz rTMS over the contralesional primary motor cortex ( M1 ) , followed by 10-session intermittent theta burst stimulation ( iTBS ) consequently over the ipsilesional M1 ; Group B underwent the same two paradigms but in reverse ; and Group C received sham stimulation that was identical to Group A.
RESULTS	We tested cortical excitability and motor assessments at the baseline , postpriming rTMS , postconsequent rTMS , and at 3-months follow-up .
RESULTS	Group A manifested greater improvement than Group B in Fugl-Meyer Assessment ( FMA ) , Wolf Motor Function testing ( WMFT ) score , and muscle strength ( P = 0.001-0 .02 ) post the priming rTMS .
RESULTS	After the consequent rTMS , Group A continued to present a superior outcome than Group B in FMA ( P = 0.015 ) and WMFT score ( P = 0.008 ) with significant behavior-electrophysiological correlation .
CONCLUSIONS	Conditioning the contralesional M1 prior to ipsilesional iTBS was found to be optimal for enhancing hand function , and this effect persisted for at least 3 months .
CONCLUSIONS	Early modulation within 6 months poststroke rebalances interhemispheric competition and appears to be a feasible time window for rTMS intervention .

###24331681
OBJECTIVE	To clarify the usefulness of protein-sparing modified formula diet in obese type 2 diabetic patients , the effects of partial use of formula diet on weight reduction and changes in related metabolic variables , and the improving rates of risk factors per 1 % body weight reduction , were compared with those of conventional subcaloric diet .
METHODS	Obese patients [ BMI > 25 kg/m ] with diabetic mellitus were randomly assigned to a low-caloric diet with partial use of formula diet group ( FD , n = 119 ) and a conventional low-caloric diet group ( CD , n = 110 ) .
METHODS	Subjects in FD took one pack of formula diet ( MicroDiet , 240 kcal/pack ) in place of one of three daily low-caloric meals for 24 weeks .
METHODS	Total daily calorie prescribed was same .
RESULTS	Weight reduction was greater in FD than in CD ( week 24 : -3.5 vs -1.4 kg ; all p < 0.001 ) .
RESULTS	Systolic blood pressure decreased significantly only in FD .
RESULTS	HbA1c reduction was greater in FD than in CD .
RESULTS	HDL-cholesterol increased significantly more in FD than in CD ( week 24 : +2.8 vs. +0.6 mg/dl , p < 0.001 ) .
RESULTS	Among several improving rates ( % ) of risk factors/1 % body weight reduction , those of HbA1c at weeks 16 and 24 , triglyceride at week 8 and HDL-cholesterol at week 24 , were significantly higher in FD than CD .
RESULTS	Doses of sulfonylurea and thiazolidinedione were significantly decreased in FD than in CD .
CONCLUSIONS	Partial use of formula diet was much more effective in reducing body weight , and also in improving coronary risk factors than conventional diet in part due to reduced body weight through decreased energy diet intake and due to dietary composition of the formula diet .

###24229688
BACKGROUND	The management of patients with refractory immune thrombocytopenia ( ITP ) is challenging , as there is no standard treatment option .
BACKGROUND	The aim of this study was to investigate the efficacy of recombinant human thrombopoietin ( rhTPO ) in combination with cyclosporin A ( CsA ) for the management of patients with corticosteroid-resistant primary ITP .
METHODS	Thirty-six patients with corticosteroid-resistant ITP were randomly divided into an observation group and control group .
METHODS	In the observation group , 19 patients received subcutaneous injection of rhTPO at a dose of 1 g/kg ( 300 U/kg ) once daily up to day 14 .
METHODS	Simultaneously they also received oral CsA at a dose of 1.5-2 .0 mg/kg twice daily for three months .
METHODS	In the control group , rhTPO alone was administered subcutaneously at 1 g/kg once daily in the other 17 ITP patients for 14 consecutive days and then the treatment was withdrawn .
RESULTS	There was no significant difference in the response rate at the end of the first week after treatment initiation between the observation group and the control group ( 63.2 % vs. 58.8 % , P > 0.05 ) , neither was there at the end of the second week ( 89.5 % vs. 94.1 % , P > 0.05 ) .
RESULTS	However , the relapse rate in the observation group was significantly lower than that in control group at the end of the first ( 17.7 % vs. 50.0 % , P < 0.05 ) , second ( 29.4 % vs. 68.8 % , P < 0.05 ) and the third month ( 29.4 % vs. 87.5 % , P < 0.01 ) .
RESULTS	In addition , rhTPO plus CsA were well tolerated and adverse events recorded were mild .
CONCLUSIONS	Combination therapy with rhTPO and CsA was effective in the management of patients with corticosteroidresistant ITP , with a relatively short time to response and low recurrence rate .
CONCLUSIONS	It might be considered as a potential secondline treatment regimen for ITP .

###24953576
OBJECTIVE	To compare the efficacy of glycerin suppository versus no suppository in preterm very-low-birthweight neonates for improving feeding tolerance .
METHODS	Randomized controlled trial .
METHODS	Level III neonatal unit from Mumbai , India .
METHODS	50 very-low-birthweight ( birth weight between 1000 to 1500 grams ) preterm ( gestational age between 28 to 32 weeks ) neonates randomized to glycerine suppository ( n = 25 ) or no intervention ( n = 26 ) .
METHODS	Glycerin suppository ( 1g ) once a day from day-2 to day-14 of life or no suppository , along with intermittent oral feeds and standardized care .
METHODS	Time required to achieve full enteral feeds ( 180 mL/kg/d ) .
RESULTS	Baseline characteristics of neonates like gestational age , birthweight , gender and age at the time of introduction of feeds were comparable in both groups .
RESULTS	The mean ( SD ) duration to reach full enteral feed was 11.90 ( 3.1 ) days in glycerin suppository group and was not significantly different ( P = 0.58 ) from control group , [ 11.33 ( 3.57 ) days ] .
RESULTS	Glycerin suppository group regained birth weight 2 days earlier than control group but this difference was not significant ( P = 0.16 ) .
RESULTS	There was no significant difference in duration of hospital stay or occurrence of necrotizing enterocolitis amongst the two study groups .
CONCLUSIONS	Once daily application of glycerin suppository does not accelerate the achievement of full feeds in preterm very-low-birthweight neonates .

###25190615
BACKGROUND	Hypokalaemia is frequently encountered in the daily clinical practices of a paediatric cardiac intensive care unit ( PCICU ) .
BACKGROUND	It is a strong independent predictor of mortality in patients with heart failure .
BACKGROUND	Thus , prompt potassium replacement therapy holds pivotal importance in therapy for hypokalaemia .
BACKGROUND	Although intravenous potassium replacement ( IVPR ) in hypokalaemia is the preferred route in most intensive care settings , it is associated with known safety risks and can lead to arrhythmias , cardiac arrest and death if inappropriately administered .
BACKGROUND	Enteral potassium replacement ( EPR ) , with its superior safety profile , may be a better alternative to IVPR .
RESULTS	Primary outcome To compare the efficacy EPR and IVPR for treatment of hypokalaemia .
RESULTS	Secondary outcome measures include a comparison of adverse effects ( hyperkalaemia , diarrhoea , gastrointestinal bleeds , nausea and vomiting ) after EPR and IVPR and a comparison of the number of dose/s required to achieve resolution of hypokalaemia for each episode of hypokalaemia .
METHODS	The Enteral Versus Intravenous Potassium Supplementation trial is designed as a randomised , controlled , non-blinded trial with two arms .
METHODS	Intervention arms will be block randomised on alternate weeks for IVPR and EPR .
METHODS	Recruited patients will receive treatment accordingly .
METHODS	For analysis , the percentage change in serum potassium levels in mEq/L after each event of potassium replacement in both arms will be used as an end point to compare the efficacy EPR and IVPR for treatment of hypokalaemia .
METHODS	The study will be conducted at the PCICU at the Aga Khan University Hospital , Karachi .
BACKGROUND	This study has been approved by the Ethics Review Committee and Clinical Trials Unit at The Aga Khan University with respect to scientific content and compliance with applicable research and human subjects regulations .
BACKGROUND	This trial is registered at Clinical Trials.Gov .
BACKGROUND	NCT02015962 .

###24810684
OBJECTIVE	Low-intensity exercise applied in anorexia nervosa patients has been shown to have a harmless effect on body composition and to effect short-term improvements in muscular strength and agility .
OBJECTIVE	The aim of this study was to determine the effects of a high-intensity resistance training program designed for adolescents to improve strength and agility in anorexia nervosa restricting-type patients ( AN-R ) .
METHODS	From a total of 36 female patients with AN-R , one group ( intervention , n = 18 ) underwent a supervised high-intensity resistance training program lasting 8 weeks , and the other group with no exercise ( control , n = 18 ) .
METHODS	Body weight , body mass index , whole-body muscular strength , and agility were assessed before , after , and 4 weeks after training ( detraining ) .
RESULTS	Leg-press , bench-press , and lateral row tests improved significantly ( p < 0.001 ) after 8 weeks of training compared with controls .
RESULTS	Improvements were maintained after the detraining period .
RESULTS	The training program also showed beneficial effects on agility .
CONCLUSIONS	A high-intensity resistance training program adapted to the recommendations for adolescents in AN-R patients was effective and safe , improving muscular strength in the whole body and the ability to perform daily tasks .
CONCLUSIONS	However , long-term maintenance of gains seems to be linked to the continuance of training or the use of a maintenance program .

###25886265
BACKGROUND	Depression is highly prevalent within individuals diagnosed with schizophrenia , and is associated with an increased risk of suicide .
BACKGROUND	There are no current evidence based treatments for low mood within this group .
BACKGROUND	The specific targeting of co-morbid conditions within complex mental health problems lends itself to the development of short-term structured interventions which are relatively easy to disseminate within health services .
BACKGROUND	A brief cognitive intervention based on a competitive memory theory of depression , is being evaluated in terms of its effectiveness in reducing depression within this group .
METHODS	This is a single blind , intention-to-treat , multi-site , randomized controlled trial comparing Positive Memory Training plus Treatment as Usual with Treatment as Usual alone .
METHODS	Participants will be recruited from two NHS Trusts in Southern England .
METHODS	In order to be eligible , participants must have a DSM-V diagnosis of schizophrenia or schizo-affective disorder and exhibit at least a mild level of depression .
METHODS	Following baseline assessment eligible participants will be randomly allocated to either the Positive Memory Training plus Treatment as Usual group or the Treatment as Usual group .
METHODS	Outcome will be assessed at the end of treatment ( 3-months ) and at 6-month and 9-month post randomization by assessors blind to group allocation .
METHODS	The primary outcome will be levels of depression and secondary outcomes will be severity of psychotic symptoms and cost-effectiveness .
METHODS	Semi-structured interviews will be conducted with all participants who are allocated to the treatment group so as to explore the acceptability of the intervention .
CONCLUSIONS	Cognitive behaviour therapy is recommended for individuals diagnosed with schizophrenia .
CONCLUSIONS	However , the number of sessions and length of training required to deliver this intervention has caused a limit in availability .
CONCLUSIONS	The current trial will evaluate a short-term structured protocol which targets a co-morbid condition often considered of primary importance by service users .
CONCLUSIONS	If successful the intervention will be an important addition to current initiatives aimed at increasing access to psychological therapies for people diagnosed with severe mental health problems .
BACKGROUND	Current Controlled Trials .
BACKGROUND	ISRCTN99485756 .
BACKGROUND	Registered 13 March 2014 .

###24867891
BACKGROUND	Manual thrombus aspiration ( TA ) is effective to reduce the thrombus burden during primary percutaneous coronary intervention for ST-elevation myocardial infarction .
BACKGROUND	The objective of this study is to assess the impact of manual TA on stent implantation during primary percutaneous coronary intervention .
RESULTS	Population of the EXAMINATION trial ( n = 1498 ) was divided into 2 groups according to the use of TA .
RESULTS	Immediate angiographic results , primary patient-oriented end point ( combination of all-cause death , myocardial infarction , and any revascularization ) and secondary device-oriented end point ( combination of cardiac death , target vessel myocardial infarction , and clinically driven target lesion revascularization ) , definite/probable stent thrombosis , and major/minor bleeding were evaluated at 2 years .
RESULTS	A total of 976 ( 65.2 % ) patients were classified into TA group and 522 ( 34.8 % ) patients into nonthrombus aspiration group .
RESULTS	Manual TA was most frequently used in patients with worse initial thrombolysis in myocardial infarction flow .
RESULTS	The TA group received less number of stents implanted ( 1.35 0.62 versus 1.45 0.71 , P = 0.005 ) with bigger size ( 3.25 0.44 versus 3.11 0.46 mm , P < 0.001 ) compared with the nonthrombus aspiration group .
RESULTS	A higher rate of direct stenting ( 69.2 % versus 43.3 % , P < 0.001 ) with lower rate of postdilatation ( 13.0 % versus 18.0 % , P < 0.009 ) was also present in the TA group compared with the nonthrombus aspiration group .
RESULTS	At 2-year follow-up , no differences in clinical end point were observed between groups .
CONCLUSIONS	Manual TA during primary percutaneous coronary intervention is associated with a higher rate of direct stenting , a lower rate of postdilatation , and larger and less stents in comparison with conventional primary percutaneous coronary intervention .
CONCLUSIONS	Conversely , manual TA had no apparent impact on clinical outcomes at long-term follow-up .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00828087 .

###26174294
BACKGROUND	Subclinical doses of propofol produce anterograde amnesia , characterized by an early failure of memory consolidation .
BACKGROUND	It is unknown how propofol affects the amygdala-dependent emotional memory system , which modulates consolidation in the hippocampus in response to emotional arousal and neurohumoral stress .
BACKGROUND	We present an event-related functional magnetic resonance imaging study of the effects of propofol on the emotional memory system in human subjects .
METHODS	Thirty-five healthy subjects were randomized to receive propofol , at an estimated brain concentration of 0.90 g ml ( -1 ) , or placebo .
METHODS	During drug infusion , emotionally arousing and neutral images were presented in a continuous recognition task , while blood-oxygen-level-dependent activation responses were acquired .
METHODS	After a drug-free interval of 2 h , subsequent memory for successfully encoded items was assessed .
METHODS	Imaging analysis was performed using statistical parametric mapping and behavioural analysis using signal detection models .
RESULTS	Propofol had no effect on the stereotypical amygdalar response to emotional arousal , but caused marked suppression of the hippocampal response .
RESULTS	Propofol caused memory performance to become uncoupled from amygdalar activation , but it remained correlated with activation in the posterior hippocampus , which decreased in proportion to amnesia .
CONCLUSIONS	Propofol is relatively ineffective at suppressing amygdalar activation at sedative doses , but abolishes emotional modulation and causes amnesia via mechanisms that commonly involve hyporesponsiveness of the hippocampus .
CONCLUSIONS	These findings raise the possibility that amygdala-dependent fear systems may remain intact even when a patient has diminished memory of events .
CONCLUSIONS	This may be of clinical importance in the perioperative development of fear-based psychopathologies , such as post-traumatic stress disorder .
BACKGROUND	NCT00504894 .

###25311220
OBJECTIVE	Four randomized studies show that adjuvant radiotherapy ( RT ) lowers the risk of subsequent ipsilateral breast events ( IBEs ) after breast-conserving surgery ( BCS ) for ductal carcinoma in situ ( DCIS ) by approximately 50 % after 10 to 15 years .
OBJECTIVE	We present 20 years of follow-up data for the SweDCIS trial .
METHODS	Between 1987 and 1999 1,046 women were randomly assigned to RT or not after BCS for primary DCIS .
METHODS	Results up to 2005 have been published , and we now add another 7 years of follow-up .
METHODS	All breast cancer events and causes of death were registered .
RESULTS	There were 129 in situ and 129 invasive IBEs .
RESULTS	Absolute risk reduction in the RT arm was 12.0 % at 20 years ( 95 % CI , 6.5 to 17.7 ) , with a relative risk reduction of 37.5 % .
RESULTS	Absolute reduction was 10.0 % ( 95 % CI , 6.0 to 14.0 ) for in situ and 2.0 % ( 95 % CI , -3.0 to 7.0 ) for invasive IBEs .
RESULTS	There was a nonstatistically significantly increased number of contralateral events in the RT arm ( 67 v 48 events ; hazard ratio , 1.38 ; 95 % CI , 0.95 to 2.00 ) .
RESULTS	Breast cancer-specific death and overall survival were not influenced .
RESULTS	Younger women experienced a relatively higher risk of invasive IBE and lower effect of RT. .
RESULTS	The hazard over time looked different for in situ and invasive IBEs .
CONCLUSIONS	Use of adjuvant RT is supported by 20-year follow-up .
CONCLUSIONS	Modest protection against invasive recurrences and a possible increase in contralateral cancers still call for a need to find groups of patients for whom RT could be avoided or mastectomy with breast reconstruction is indicated .

###24945393
OBJECTIVE	Surgical incision closure , as well as total joint replacement itself , plays a key role in the overall outcome of an arthroplasty procedure .
OBJECTIVE	Uncomplicated wound healing is the essential condition of successful rehabilitation and the patient 's return to normal activities .
OBJECTIVE	Although there are many innovative suturing techniques which offer advantages , their safety is still being discussed .
OBJECTIVE	The aim of this prospective non-blind randomised study was to evaluate wound healing and complications in relation to skin incision closure with either conventional suture or metal staples .
METHODS	A total of 72 patients , 21 men and 51 women , who underwent a standard primary total knee arthroplasty ( TKA ) at our department in the period from January till June 2013 , were evaluated .
METHODS	They were allocated to two groups by random assignment based on the patient 's date of birth ( even or odd day of birth ) .
METHODS	In group 1 ( n = 39 ) skin was closed using metal staples ( Leukosan Skin Stapler ) , in group 2 ( n = 33 ) , conventional continuous Donati suture was used .
METHODS	The groups , previously assessed as independent and comparable in terms of age , gender and BMI , were compared in the following criteria : suturing time , duration of wound drainage , wound healing , complications , resuturing when necessary , and their relation to the body mass index , skin plica thickness and co-morbidities potentially complicating soft tissue healing .
METHODS	The differences were statistically evaluated by parametric and non-parametric tests , i.e. , the median test , ( 2 ) - test , Student 's t-test , Fisher 's exact test and Pearson 's correlation coefficient .
METHODS	The statistical significance of differences was set at a level of 0.05 .
RESULTS	A significant difference ( p < 0.005 ) between the groups was found in suturing time ; the median time for staples was 81 sec in comparison with 290 sec for conventional suture .
RESULTS	In both groups , staples or sutures were removed on the 12 th postoperative day and there was no difference in wound drainage ( median time , 5 days ; p = 0.891 for both ) .
RESULTS	Treatment for late discharge was required in two sutured wounds ( 6.1 % ) and in three stapled wounds ( 7.7 % ) .
RESULTS	One of the latter was due to early deep wound infection , which later resulted in revision TKA .
RESULTS	The groups did not differ in the values of either BMI or plica thickness ( Pearson 's r ) .
CONCLUSIONS	Views on alternative suture techniques for skin closure in orthopaedic surgery vary .
CONCLUSIONS	In this study , the use of metal staples or conventional suture is compared between two groups of patients undergoing TKA , i.e. , the same type of procedure .
CONCLUSIONS	The advantage of staples involves a quick and simple application but , as reported , removal may be more painful with staples than with stitches , and much depends on the technique of staple application .
CONCLUSIONS	The continuous suture technique may produce skin strangulation at wound margins , which will complicate healing .
CONCLUSIONS	Staples minimise this risk and are therefore commonly used in TKA surgery .
CONCLUSIONS	However , only very few studies comparing these two suture techniques in TKA patients have been published .
CONCLUSIONS	Correctly performed skin suturing by means of metal staples is not associated with a higher complication rate and is therefore a simple , rapid , efficient and economical alternative to the conventional suture technique .

###26442398
BACKGROUND	Fluid overload in infants can result from inappropriate volume expansion ( VE ) .
BACKGROUND	The aim of this work was to evaluate the beneficial values of Transoesophageal Doppler TED in intraoperative fluid guidance versus standard clinical monitoring parameters in infants undergoing Kasai operation .
METHODS	Forty infants scheduled for Kasai procedure were randomly allocated into two groups ( Doppler and clinical group ) .
METHODS	In Doppler group decided to provide VE ( 10-30 m1/kg of Hydroxyethyl starches HES ) when the index stroke volume decreased by 15 % from the baseline value , in clinical group , hemodynamic variables triggering colloid administration mean arterial blood pressure ( MAP ) less than 20 % below baseline or central venous pressure ( CVP ) < 5 cmH2O in both groups : Ringer 's acetate was infused at constant rate ( 6 m 1/kg/h ) .
METHODS	Standard and TED-derived data were recorded before and after VE .
METHODS	Follow up the postoperative outcome and hospital stay .
RESULTS	There were significantly lower mean volume of HES ( 42.85 3.93 versus 84 14.29 ml ) and percent of infants required it ( 30 % versus 90 % ) associated with earlier tolerance to oral feeding ( 2 0.66 versus 3.4 0.51 ) , shorter hospital stay ( 5.30 0.47 versus 6.7 [ symbols : see text ] days ) and lower rate of chest infection ( 15 % versus 30 % ) in Doppler group than clinical group .
RESULTS	There was no difference between the two studied groups regarding heart rate , MAP .
CONCLUSIONS	TED guided intraoperative fluid intake in infants undergoing Kasai operation optimize fluid consumption and improve outcome associated with shorter hospital stay .

###25022834
BACKGROUND	High sodium intake during infancy and early childhood can change salt preference and blood pressure trajectories across life , representing a modifiable cardiovascular risk factor .
BACKGROUND	Describing young children 's sodium intake is important for informing effective targets for sodium reduction .
OBJECTIVE	This study aimed to describe food sources and demographic and behavioral correlates of sodium intake in 295 young Australian children using three unscheduled 24-hour recalls ( when children were 9 and then 18 months of age ) with mothers participating within an existing randomized controlled trial , the Melbourne Infant Feeding Activity and Nutrition Trial ( InFANT ) Program .
METHODS	Differences in individual-level and family-level demographic and behavioral variables were assessed across tertiles of sodium density ( mg/1 ,000 kcal ) .
METHODS	Descriptive statistics were used to describe food-group contributions to total energy and sodium intakes at both ages .
RESULTS	Mean sodium intake was 486 mg ( standard deviation = 232 mg ) at 9 months and had more than doubled to 1,069 mg ( standard deviation = 331 mg ) at 18 months of age .
RESULTS	Fifty-four percent of children at 18 months exceeded the Recommended Daily Upper Level for sodium intake , with bread , cheese , breakfast cereal , soup , and mixed dishes all important sources of sodium at both ages .
RESULTS	Yeast extracts , processed meats , and bread products became important additional sources at 18 months .
RESULTS	A greater proportion of children in the highest sodium-density tertile had ceased breastfeeding and had commenced solids at an earlier age .
CONCLUSIONS	The key food sources of sodium for children younger than 2 years are those that contribute to the whole population 's high salt burden and highlight the essential role governments and food industry must play to reduce salt in commonly consumed foods .

###24735588
BACKGROUND	Delirium is a common complication in patients with hip fractures and is associated with an increased risk of subsequent dementia .
BACKGROUND	The aim of this trial was to evaluate the effect of a pre - and postoperative orthogeriatric service on the prevention of delirium and longer-term cognitive decline .
METHODS	This was a single-center , prospective , randomized controlled trial in which patients with hip fracture were randomized to treatment in an acute geriatric ward or standard orthopedic ward .
METHODS	Inclusion and randomization took place in the Emergency Department at Oslo University hospital .
METHODS	The key intervention in the acute geriatric ward was Comprehensive Geriatric Assessment including daily interdisciplinary meetings .
METHODS	Primary outcome was cognitive function four months after surgery measured using a composite outcome incorporating the Clinical Dementia Rating Scale ( CDR ) and the 10 words learning and recalls tasks from the Consortium to Establish a Registry for Alzheimer 's Disease battery ( CERAD ) .
METHODS	Secondary outcomes were pre - and postoperative delirium , delirium severity and duration , mortality and mobility ( measured by the Short Physical Performance Battery ( SPPB ) ) .
METHODS	Patients were assessed four and twelve months after surgery by evaluators blind to allocation .
RESULTS	A total of 329 patients were included .
RESULTS	There was no significant difference in cognitive function four months after surgery between patients treated in the acute geriatric and the orthopedic wards ( mean 54.7 versus 52.9 , 95 % confidence interval for the difference -5.9 to 9.5 ; P = 0.65 ) .
RESULTS	There was also no significant difference in delirium rates ( 49 % versus 53 % , P = 0.51 ) or four month mortality ( 17 % versus 15 % , P = 0.50 ) between the intervention and the control group .
RESULTS	In a pre-planned sub-group analysis , participants living in their own home at baseline who were randomized to orthogeriatric care had better mobility four months after surgery compared with patients randomized to the orthopedic ward , measured with SPPB ( median 6 versus 4 , 95 % confidence interval for the median difference 0 to 2 ; P = 0.04 ) .
CONCLUSIONS	Pre - and postoperative orthogeriatric care given in an acute geriatric ward was not effective in reducing delirium or long-term cognitive impairment in patients with hip fracture .
CONCLUSIONS	The intervention had , however , a positive effect on mobility in patients not admitted from nursing homes .
BACKGROUND	ClinicalTrials.gov NCT01009268 Registered November 5 , 2009 .

###24560350
BACKGROUND	Shockwave was shown to enhance the healing of anterior cruciate ligament ( ACL ) reconstruction in rabbits .
BACKGROUND	This study evaluated the effect of extracorporeal shockwave therapy ( ESWT ) on ACL reconstruction in human subjects .
BACKGROUND	We hypothesized that ESWT may improve human ACL reconstruction .
METHODS	Fifty-three patients were randomized into two groups with 26 patients in ESWT group and 27 patients in control group .
METHODS	The ESWT group underwent single-bundle hamstring autograft ACL reconstruction and received ESWT immediately after surgery .
METHODS	The control group underwent ACL surgery without ESWT .
METHODS	Both groups received the same rehabilitation postoperatively .
METHODS	The evaluations included Lysholm score , IKDC score and KT-1000 , radiograph , bone mineral density , and magnetic resonance imaging .
RESULTS	ESWT group showed significantly better Lysholm score than control group at 1 and 2y postoperatively ( P < 0.001 and 0.001 , respectively ) .
RESULTS	No significant difference was noted in IKDC score between the two groups ( P = 0.080 and 0.076 , respectively ) .
RESULTS	The KT-1000 values were significantly better in ESWT group than control group at 2y postoperatively ( P = 0.027 ) .
RESULTS	The tibia tunnel on X-ray was significantly smaller in ESWT group compared with control group at 2y ( P = 0.018 ) .
RESULTS	The bone mineral density values showed no discernable difference between the two groups at 6mo and 2y ( P = 0.522 and 0.984 , respectively ) .
RESULTS	On magnetic resonance imaging , ESWT group showed significant decrease in tibia tunnel enlargement at 6mo and 2y compared with the control group ( P = 0.024 and < 0.001 , respectively ) .
CONCLUSIONS	ESWT significantly improves the subjective Lysholm score and decreases the middle 1/3 tibia tunnel enlargement after single hamstring autograft ACL reconstruction .

###25189288
OBJECTIVE	The objective was to compare the effectiveness of repositioning every 2 or 4 h for preventing pressure ulcer development in patients in intensive care unit under mechanical ventilation ( MV ) .
METHODS	This was a pragmatic , open-label randomized clinical trial in consecutive patients on an alternating pressure air mattress ( APAM ) requiring invasive MV for at least 24 h in a university hospital in Spain .
METHODS	Eligible participants were randomly assigned to groups for repositioning every 2 ( n = 165 ) or 4 ( n = 164 ) h.
METHODS	The primary outcome was the incidence of a pressure ulcer of at least grade II during ICU stay .
RESULTS	A pressure ulcer of at least grade II developed in 10.3 % ( 17/165 ) of patients turned every 2 h versus 13.4 % ( 22/164 ) of those turned every 4 h ( hazard ratio [ HR ] 0.89 , 95 % confidence interval [ CI ] 0.46-1 .71 , P = 0.73 ) .
RESULTS	The composite end point of device-related adverse events was recorded in 47.9 versus 36.6 % ( HR 1.50 , CI 95 % 1.06-2 .11 , P = 0.02 ) , unplanned extubation in 11.5 versus 6.7 % ( HR 1.77 , 95 % CI 0.84-3 .75 , P = 0.13 ) , and endotracheal tube obstruction in 36.4 versus 30.5 % , respectively ( HR 1.44 , 95 % CI 0.98-2 .12 , P = 0.065 ) .
RESULTS	The median ( interquartile range ) daily nursing workload for manual repositioning was 21 ( 14-27 ) versus 11 min/patient ( 8-15 ) ( P < 0.001 ) .
CONCLUSIONS	A strategy aimed at increasing repositioning frequency ( 2 versus 4 h ) in patients under MV and on an APAM did not reduce the incidence of pressure ulcers .
CONCLUSIONS	However , it did increase device-related adverse events and daily nursing workload .

###24640439
OBJECTIVE	To compare the bond strength to human primary dentin of a self-adhesive light-curing resin composite , a self-etch adhesive and a glass-ionomer cement by means of microshear bond strength ( pSBS ) test and scanning electron microscopic ( SEM ) observations .
METHODS	75 human primary molars were sectioned to obtain a 2 mm-thick slab of mid-coronal dentin , randomly divided into three groups ( n = 25 ) .
METHODS	Nine conical frustum-shaped buildups were constructed on the occlusal surface of each dentin slab using a self-adhesive light-curing resin composite ( Vertise Flow ; Group 1 ) , bonding agent ( Optibond All-in-One ; Group 2 ) combined with resin composite ( Premise Flow ) and a glass-ionomer cement ( Ketac-Fil ; Group 3 ) .
METHODS	After thermocycling , specimens were subjected to microSBS test .
METHODS	All debonded specimens were observed at SEM .
METHODS	Data were analyzed by a mixed model and chi-square test .
RESULTS	The bond strength measured in Group 1 ( 9.0 + / - 4.5 MPa ) was significantly lower than that one recorded in Group 2 ( 20.2 + / -12.5 MPa ) although it was significantly higher than the one recorded in Group 3 ( 4.8 + / - 2.3 MPa ) .
RESULTS	Failures were mainly adhesive in all groups .

###24247662
OBJECTIVE	This study examined potential predictors of nurses ' intentions to work during the 2009 influenza A ( H1N1 ) pandemic .
METHODS	A questionnaire was mailed to a random sample of 1,200 nurses chosen from all RNs and LPNs registered with the Maine State Board of Nursing during the second wave of the flu pandemic .
RESULTS	Of the 735 respondents , 90 % initially indicated that they intended to work during a flu pandemic .
RESULTS	Respondents were significantly more likely to work if provided with adequate personal protective equipment ( PPE ) but significantly less likely without adequate PPE or if they feared family members could become ill with pandemic flu .
RESULTS	They were also significantly less likely to work if assigned to direct care of a flu patient ; if a colleague were quarantined for or died of pandemic flu ; if they feared their own family members might die of pandemic flu ; if they themselves were ill for any reason ; if a family member or loved one were sick at home and needed care ; if they lacked a written family protection plan ; or if certain incentives were offered : antiviral medication or vaccine for nurse and family , double pay , or free room and board at work .
RESULTS	About 7 % of RNs reported that they would not be willing to work during a flu pandemic , regardless of incentives or other factors .
RESULTS	An inverse relationship was found between the perceived level of threat posed by a flu pandemic and nurses ' willingness to work .
CONCLUSIONS	To maintain an adequate nursing workforce during a flu pandemic , employers should ensure that policies and procedures include providing adequate PPE for nurses and safeguarding the health of nurses and their families .
CONCLUSIONS	The level of perceived threat is likely to affect the proportion of nurses willing to work .
CONCLUSIONS	Some nurses will not work during a flu pandemic no matter what protections and incentives are offered ; efforts intended to force or entice all nurses to work are unlikely to succeed .

###24480899
OBJECTIVE	Psychological treatments for posttraumatic stress disorder ( PTSD ) are usually delivered once or twice a week over several months .
OBJECTIVE	It is unclear whether they can be successfully delivered over a shorter period of time .
OBJECTIVE	This clinical trial had two goals : to investigate the acceptability and efficacy of a 7-day intensive version of cognitive therapy for PTSD and to investigate whether cognitive therapy has specific treatment effects by comparing intensive and standard weekly cognitive therapy with an equally credible alternative treatment .
METHODS	Patients with chronic PTSD ( N = 121 ) were randomly allocated to 7-day intensive cognitive therapy for PTSD , 3 months of standard weekly cognitive therapy , 3 months of weekly emotion-focused supportive therapy , or a 14-week waiting list condition .
METHODS	The primary outcomes were change in PTSD symptoms and diagnosis as measured by independent assessor ratings and self-report .
METHODS	The secondary outcomes were change in disability , anxiety , depression , and quality of life .
METHODS	Evaluations were conducted at the baseline assessment and at 6 and 14 weeks ( the posttreatment/wait assessment ) .
METHODS	For groups receiving treatment , evaluations were also conducted at 3 weeks and follow-up assessments at 27 and 40 weeks after randomization .
METHODS	All analyses were intent-to-treat .
RESULTS	At the posttreatment/wait assessment , 73 % of the intensive cognitive therapy group , 77 % of the standard cognitive therapy group , 43 % of the supportive therapy group , and 7 % of the waiting list group had recovered from PTSD .
RESULTS	All treatments were well tolerated and were superior to waiting list on nearly all outcome measures ; no difference was observed between supportive therapy and waiting list on quality of life .
RESULTS	For primary outcomes , disability , and general anxiety , intensive and standard cognitive therapy were superior to supportive therapy .
RESULTS	Intensive cognitive therapy achieved faster symptom reduction and comparable overall outcomes to standard cognitive therapy .
CONCLUSIONS	Cognitive therapy for PTSD delivered intensively over little more than a week was as effective as cognitive therapy delivered over 3 months .
CONCLUSIONS	Both had specific effects and were superior to supportive therapy .
CONCLUSIONS	Intensive cognitive therapy for PTSD is a feasible and promising alternative to traditional weekly treatment .

###25391155
BACKGROUND	Modafinil is a medication licensed for the treatment of narcolepsy .
BACKGROUND	However , it has been reported that healthy individuals without wakefulness disorders are using modafinil off-label to enhance cognitive functioning .
BACKGROUND	Although some studies have reported that modafinil improves cognitive task performance in healthy volunteers , numerous other studies have failed to detect cognitive enhancing effects of modafinil on several well-established neuropsychological tasks .
BACKGROUND	Interestingly , several clinical and preclinical studies have found that improved cognitive task performance by modafinil is accompanied by slower response times .
BACKGROUND	This observation raises the question as to whether this slowing of response time in healthy volunteers is a necessary and sufficient condition for cognitive enhancement with modafinil .
BACKGROUND	The aim of the current experiment was to explore this question by investigating the effects of modafinil on the Hayling Sentence Completion Test ( HSCT ) .
METHODS	Sixty-four healthy volunteers received either a single dose ( 200 mg ) of modafinil ( n = 32 ) or placebo ( n = 32 ) in a randomized , double-blind , placebo-controlled , parallel group study in which the principal outcome measures were response latencies on the response initiation and response inhibition sections of the HSCT .
RESULTS	Participants dosed with modafinil had significantly longer mean response latencies on the HSCT for both the response initiation and response inhibition compared to participants dosed with placebo .
RESULTS	However , participants in both groups made a similar number of errors on each of these measures , indicating that modafinil did not enhance the accuracy of performance of the task relative to placebo .
CONCLUSIONS	This study demonstrated that administration of single 200 mg doses of modafinil to healthy individuals increased the latency of responses in the performance of the HSCT , a task that is highly sensitive to prefrontal executive function , without enhancing accuracy of performance .
CONCLUSIONS	This finding may provide important clues to defining the limitations of modafinil as a putative cognitive enhancer .
BACKGROUND	ClinicalTrials.gov NCT02051153 .

###25139539
BACKGROUND	Subjects with diabetes mellitus ( DM ) develop gait dysfunction contributing to falls , reluctance to perform activities and injuries .
BACKGROUND	Neuropathic pain ( NeP ) related to diabetic peripheral neuropathy ( DPN ) is associated with increased gait variability that may contribute to gait dysfunction .
BACKGROUND	We used a portable device ( GaitMeter ) and related gait and balance measures to measure gait parameters in painful DPN ( PDPN ) subjects prior to and during analgesia .
BACKGROUND	Our hypothesis was that PDPN subjects would have decreased gait step variability when receiving pharmacological relief of NeP .
METHODS	DPN subjects with at least moderate NeP were assessed in a randomized , double-blind crossover study of pregabalin versus placebo .
METHODS	The outcome measure was variability in step length and step velocity .
METHODS	Testing for Timed Get-Up-and-Go Test , Tinetti Mobility Scales , Sway Testing , a Physiological Profile Approach , and fall-related surveys were also performed .
METHODS	DPN severity was quantified using the Utah Early Neuropathy Score .
RESULTS	PDPN subjects developed increased , rather than decreased , step length and step velocity variability during pregabalin treatment .
RESULTS	There were no significant differences between cohorts for other physiological gait and balance testing .
RESULTS	Non-significant NeP relief occurred in the pregabalin phase of study as compared with placebo .
RESULTS	There was a negative relationship for step length with pain severity .
CONCLUSIONS	Analgesia did not decrease gait variability in PDPN patients , and in fact , increased gait variability was seen during pregabalin treatment .
CONCLUSIONS	Other important relationships of gait dysfunction with PDPN should be sought .

###25367242
BACKGROUND	It has been suggested that off-pump coronary artery bypass grafting ( CABG ) surgery reduces myocardial ischemia-reperfusion injury , postoperative systemic inflammatory response , and oxidative stress .
BACKGROUND	The aim of this study was to measure serum malondialdehyde ( MDA ) , high-sensitivity C-reactive protein ( hs-CRP ) , M30 , and M65 levels and to investigate the relationship between M30 levels and oxidative stress and inflammation in patients undergoing on-and off-pump CABG surgery .
METHODS	Fifty patients were randomly assigned to on-pump or off-pump CABG surgery ( 25 patients off-pump and 25 on-pump CABG surgery ) , and blood samples were collected prior to surgery , and 30 minutes , 60 minutes , 6 hours , and 24 hours after CABG surgery .
RESULTS	Compared to the on-pump group , serum MDA levels at 30 minutes , 60 minutes , 6 hours , and 24 hours after the CABG surgery were significantly lower in the off-pump group ( P = .001 , P = .001 , P = .001 , and P = .001 , respectively ) .
RESULTS	Serum M30 levels were found to be elevated in both groups , returning to baseline at 24 hours .
RESULTS	When compared to baseline , the hs-CRP level reached its peak at 24 hours at 13.285.32 mg/dL in the on-pump group , and 15.444.02 mg/dL in the off-pump group .
CONCLUSIONS	CABG surgery is associated with an increase in inflammatory markers and serum M30 levels , indicating epithelial/endothelial apoptosis in the early period .

###25141241
OBJECTIVE	To determine the efficacy of a 14-day regimen of esomeprazole 20 mg for the treatment of frequent heartburn in subjects who are likely to self-treat with over-the-counter medications without consulting a health care provider .
METHODS	Adults with frequent heartburn 2 days per week in the past 4 weeks were randomly assigned to 14-day double-blind treatment with esomeprazole 20 mg once daily or placebo in 2 identical multicenter studies ( ClinicalTrials.gov identifiers : NCT01370525 , NCT01370538 ) .
METHODS	The primary efficacy outcome was percentage of heartburn-free 24-hour days across 14 days .
METHODS	Secondary efficacy outcomes included heartburn resolution , defined as heartburn 2 days over 14 days , and percentages of subjects reporting 1 day with heartburn in the first and final weeks of treatment .
METHODS	Subjects recorded data in daily self-assessment diaries .
RESULTS	The percentage of heartburn-free 24-hour days over 14 days was significantly higher ( P < 0.0001 ) in subjects receiving esomeprazole 20 mg compared with placebo in study 1 ( N = 331 ; 46.13 % vs. 33.07 % , respectively ) and study 2 ( N = 320 ; 48.00 % vs 32.75 % , respectively ) .
RESULTS	Significantly more subjects treated with esomeprazole 20 mg had heartburn resolution over 14 days and in the first and final weeks compared with placebo .
RESULTS	Within the first 4 days , the proportion of subjects with heartburn-free days was significantly greater with esomeprazole 20 mg versus placebo .
RESULTS	Treatment was generally well tolerated , with a safety pattern consistent with the known profile for esomeprazole .
CONCLUSIONS	A 14-day regimen of esomeprazole 20 mg once daily was effective for treating frequent heartburn in subjects who are likely to self-treat with over-the-counter medications .

###25752969
BACKGROUND	In 2002 , the Danish Cancer Society opened a rehabilitation centre in which cancer patients were offered a free , six-day , multidimensional residential course .
BACKGROUND	Our previous studies of the effects of this course at one and six months of follow-up showed no positive effect on distress .
BACKGROUND	We investigated long-term effects at 12 months of follow-up and whether subgroups with fewer psychosocial resources received more benefit from the intervention than patients with better resources .
METHODS	In two Danish counties , 507 patients with breast , prostate , colon or rectum cancer diagnosed within the past two years who had completed primary treatment were randomised to a six-day , multidimensional residential rehabilitation course or to standard care .
METHODS	Of these , 208 patients received the allocated intervention and 244 received the allocated control condition and were included in the analyses .
METHODS	Patients in both groups completed questionnaires at baseline and at one , six and 12 months of follow-up , including the ` Profile of Mood States short form ' , the ` General Self-efficacy ' scale and a question on emotional support .
METHODS	At 12 months of follow-up , 179 participants in the intervention group and 195 in the control group provided data .
RESULTS	No effect of the intervention was found on distress at 12 months of follow-up , even in subgroups with fewer psychosocial resources at baseline , i.e. greater baseline distress , poorer self-efficacy and less emotional support .
CONCLUSIONS	Multidimensional rehabilitation programmes may not be effective in the treatment of distress .
CONCLUSIONS	During the past few decades , studies of psychotherapy or psycho-education in cancer patients have shown small to moderate effects .
CONCLUSIONS	More focused rehabilitation programmes may be more effective .

###24380637
OBJECTIVE	To verify the technical feasibility of low contrast volume ( 40 mL ) run-off CT angiography ( run-off CTA ) with the individual scan time optimization based on double-level test bolus technique .
METHODS	A prospective study of 92 consecutive patients who underwent run-off CTA performed with 40 mL of contrast medium ( injection rate of 6 mL/s ) and optimized scan times on a second generation of dual-source CT. .
METHODS	Individual optimized scan times were calculated from aortopopliteal transit times obtained on the basis of double-level test bolus technique -- the single injection of 10 mL test bolus and dynamic acquisitions in two levels ( abdominal aorta and popliteal arteries ) .
METHODS	Intraluminal attenuation ( HU ) was measured in 6 levels ( aorta , iliac , femoral and popliteal arteries , middle and distal lower-legs ) and subjective quality ( 3-point score ) was assessed .
METHODS	Relations of image quality , test bolus parameters and arterial circulation involvement were analyzed .
RESULTS	High mean attenuation ( HU ) values ( 468 ; 437 ; 442 ; 440 ; 342 ; 274 ) and quality score in all monitored levels was achieved .
RESULTS	In 91 patients ( 0.99 ) the sufficient diagnostic quality ( score 1-2 ) in aorta , iliac and femoral arteries was determined .
RESULTS	A total of 6 patients ( 0.07 ) were not evaluable in distal lower-legs .
RESULTS	Only the weak indirect correlation of image quality and test-bolus parameters was proved in iliac , femoral and popliteal levels ( r values : -0.263 , -0.298 and -0.254 ) .
RESULTS	The statistically significant difference of the test-bolus parameters and image quality was proved in patients with occlusive and aneurysmal disease .
CONCLUSIONS	We proved the technical feasibility and sufficient quality of run-off CTA with low volume of contrast medium and optimized scan time according to aortopopliteal transit time calculated from double-level test bolus .

###24529502
BACKGROUND	Clopidogrel therapy has recently been shown to reduce cardiovascular events in patients with stable vascular disease .
BACKGROUND	This benefit may be due to effects not exclusively related to platelet aggregation .
BACKGROUND	The aim of this study was to evaluate the effect of clopidogrel therapy on microvascular endothelial function in subjects with stable coronary artery disease ( CAD ) .
RESULTS	Forty subjects with stable CAD were randomised to clopidogrel therapy ( 75mg/day ) or control .
RESULTS	Blood and endothelial function testing occurred at baseline , one week and three months following randomisation .
RESULTS	Microvascular endothelial function was assessed via reactive hyperaemic index ( RHI ) .
RESULTS	Platelet function was assessed by adenosine diphosphate ( ADP ) - induced whole blood aggregation and the VerifyNow system .
RESULTS	Plasma markers of endothelial function ( asymmetric dimethylarginine , ADMA ) and oxidative stress ( myeloperoxidase , MPO ) were also tested .
RESULTS	The primary endpoint was endothelial function assessment ( RHI ) at three months .
RESULTS	At one week RHI increased by 2010 % in the clopidogrel group ; this effect was maintained at three months ( 219 % increase from baseline ; P < 0.01 ) .
RESULTS	A significant decrease in ADP-induced platelet aggregation and P2Y12 reaction units was observed in the clopidogrel therapy group ( P < 0.01 ) .
RESULTS	There was no correlation between endothelial function and platelet function testing in the clopidogrel therapy group .
CONCLUSIONS	Clopidogrel therapy is associated with improved microvascular endothelial function in patients with stable CAD .
CONCLUSIONS	This effect is independent of its effects on ADP-induced platelet reactivity .

###25224595
OBJECTIVE	To investigate if adding Caphosol ( ) , a mouthwash solution , to oral cryotherapy ( OC ) further protects against oral mucositis ( OM ) , a toxic painful complication to high dose chemotherapy .
METHODS	The study was a randomised , controlled , study design .
METHODS	Patients 16 years scheduled for allogeneic stem cell transplantation were included consecutively and randomised to experimental group receiving OC combined with Caphosol ( ) ( n = 20 ) or control group receiving OC only ( n = 20 ) .
METHODS	OC was given from start to end of HDCT .
METHODS	Caphosol ( ) , from day 0 to day 21 .
RESULTS	There were no significant differences regarding age or gender between the groups .
RESULTS	Mucositis was assessed with the World Health Organisation ( WHO ) grading scale .
RESULTS	Pain was assessed with a 10 cm visual analogue scale ( VAS ) from 0 = no pain to 10 = worst imaginable pain .
RESULTS	Start and duration of therapy with pain relieving drugs , serum C-reactive protein values , and number of days of hospitalisation were collected from the medical records .
RESULTS	Data on OM , oral pain , use of i.v. opioids and total parenteral nutrition were collected during 22 days .
RESULTS	There was no significant difference between the groups on OM , oral pain , use of i.v. opioids or TPN between the groups .
CONCLUSIONS	The study showed no additional effect of combining Caphosol ( ) with OC .

###24770699
BACKGROUND	The health benefits of exercise are well established .
BACKGROUND	However , the relationship between exercise volume and intensity and health benefits remains unclear , particularly the benefits of low-volume and intensity exercise .
OBJECTIVE	The primary purpose of this investigation was , therefore , to examine the dose-response relationship between exercise volume and intensity with derived health benefits including volumes and intensity of activity well below international recommendations .
METHODS	Generally healthy , active participants ( n = 72 ; age = 44 13 years ) were assigned randomly to control ( n = 10 ) or one of five 13-week exercise programs : ( 1 ) 10-min brisk walking 1/week ( n = 10 ) , ( 2 ) 10-min brisk walking 3/week ( n = 10 ) , ( 3 ) 30-min brisk walking 3/week ( n = 18 ) , ( 4 ) 60-min brisk walking 3/week ( n = 10 ) , and ( 5 ) 30-min running 3/week ( n = 14 ) , in addition to their regular physical activity .
METHODS	Health measures evaluated pre - and post-training including blood pressure , body composition , fasting lipids and glucose , and maximal aerobic power ( VO2max ) .
RESULTS	Health improvements were observed among programs at least 30 min in duration , including body composition and VO2max : 30-min walking 28.8-34 .5 mL kg ( -1 ) min ( -1 ) , 60-min walking 25.1-28 .9 mL kg ( -1 ) min ( -1 ) , and 30-min running 32.4-36 .4 mL kg ( -1 ) min ( -1 ) .
RESULTS	The greater intensity running program also demonstrated improvements in triglycerides .
CONCLUSIONS	In healthy active individuals , a physical activity program of at least 30 min in duration for three sessions/per week is associated with consistent improvements in health status .

###24854049
BACKGROUND	Obesity-related comorbidities frequently contribute to acute illness .
BACKGROUND	Obesity interventions during hospitalization are not often utilized but may be effective .
OBJECTIVE	To examine whether inpatient weight loss intervention with postdischarge follow-up results in weight loss at 6 months when compared to control .
METHODS	Prospective , randomized controlled trial .
METHODS	Academic medical center in Chicago , Illinois .
METHODS	Obese adult inpatients .
METHODS	Intervention subjects viewed a weight education video , underwent personalized counseling , and set specific weight loss , dietary , and fitness goals prior to discharge .
METHODS	All participants were followed by phone over the subsequent 6 months .
METHODS	The trial was unblinded to participants , physicians , and investigators .
METHODS	Primary outcome was weight change between groups at 6 months .
METHODS	Weight change from baseline and waist-to-hip ratios ( WHR ) were also assessed .
RESULTS	For 176 participants in the intention-to-treat analysis , mean baseline weight for the intervention group was 107.7 kg ( standard deviation [ SD ] = 16.7 ) and 105.1 kg ( SD = 17.4 ) for controls .
RESULTS	Mean weight loss at 6 months was 1.08 kg ( SD = 4.33 ) for intervention subjects and 1.35 kg ( SD = 3.65 ) among controls .
RESULTS	There was no significant difference in weight loss between groups at 6 months ( P = 0.26 ) .
RESULTS	As-treated analysis yielded similar results .
RESULTS	There were no differences in WHRs between the intervention and control at 6 months ( 0.04 vs 0.04 , P = 0.59 ) .
CONCLUSIONS	We found no difference in weight loss between the intervention and control groups at 6 months .

###24219770
OBJECTIVE	The purpose of this study was to determine the acceptability of peer - and health-professional-led self-management education using the Stanford Program with Australian veterans and their partners .
METHODS	The 6-week program taught problem-solving and decision-making skills to activate healthful behaviors , including action-planning and goal-setting .
METHODS	The evaluation included a participant and facilitator postprogram questionnaire ; group interview ; and alcohol , posttraumatic stress disorder , anxiety , depression , anger , relationship , and quality-of-life measures as part of a randomized controlled study .
RESULTS	Participants included 25 male veterans with comorbid alcohol dependency , psychiatric and medical conditions , and 18 female partners ( n = 43 ) , 61.5 % of who reported a chronic condition .
RESULTS	The primary outcome was a self-reported improvement in self-management of their conditions in 69 % of participants , with another 22.2 % reporting that their confidence to self-manage had improved .
RESULTS	There was an improvement in all measures at 9 months .
CONCLUSIONS	The program resulted in improvements in lifestyle and confidence in self-management for Vietnam veterans , a cohort difficult to engage in healthy behaviors .
CONCLUSIONS	Most participants were also accompanied by their partners .
CONCLUSIONS	The program is a valuable resource for providing self-management education to veterans with alcohol dependency and various chronic conditions and needs to be considered in the suite of rehabilitation programs available to Defense Force personnel , veterans , and their partners .

###24755124
OBJECTIVE	The objectives of the studies reported here were to determine the relative bioavailability of linagliptin and metformin when administered in a fixed-dose combination ( FDC ) tablet with and without food , and to investigate the relative bioavailability of linagliptin and metformin FDC tablets from two treatment batches with different dissolution behavior .
METHODS	These studies were open-label , single-dose , randomized , two-way crossover trials .
METHODS	After an overnight fast , healthy volunteers received an FDC tablet once ( with/without food in the food-effect study ; or from one of two batches with differing dissolution behavior in the tablet-dissolution study ) .
METHODS	On a separate visit , following a washout period of 35 days , participants received the alternative treatment .
METHODS	In the food-effect study the primary endpoints were maximum measured concentration in plasma ( C ( max ) ) for linagliptin and metformin , area under the plasma concentration-time curve from 0 to 72 hours ( AUC ( 0-72 ) ) for linagliptin and from 0 to infinity ( AUC ( 0-inf ) ) for metformin .
METHODS	In the tablet-dissolution study the primary endpoints were Cmax for both analytes , AUC ( 0-72 ) for linagliptin , and from 0 to the time of the last quantifiable data point ( AUC ( 0-t ) ) for metformin .
RESULTS	The administration of the FDC tablet with food had no influence on the relative bioavailability of linagliptin and metformin with regard to the extent of exposure as determined by AUC ( 0-72 ) ( linagliptin ) and AUC ( 0-inf ) ( metformin ) compared with FDC tablet administration while fasting .
RESULTS	After food intake , peak plasma concentrations of linagliptin were slightly lowered ( from 4.99 to 4.56 nmol L ) , but the 90 % confidence interval ( CI ) of the geometric mean test/reference ratio was still located within the generally applied bioequivalence acceptance limits of 80 - 125 % .
RESULTS	The median time from dosing to the maximum concentration of linagliptin in plasma ( t ( max ) ) was similar under both conditions .
RESULTS	Administration with food reduced the rate of absorption of metformin indicated by a prolongation in median tmax ( from 2 to 4 hours ) and a decrease in Cmax by ~ 18 % .
RESULTS	There were no notable differences between the two treatment groups with respect to safety and tolerability .
RESULTS	In the tablet-dissolution study , bioequivalence was demonstrated between linagliptin/metformin FDC tablets with normal and slower dissolution characteristics .
RESULTS	For both linagliptin and metformin , the 90 % CI of all pharmacokinetic ( PK ) parameters were well within the bioequivalence acceptance limits of 80 - 125 % .
RESULTS	Tablets from both batches were well tolerated with no unexpected adverse events .
CONCLUSIONS	Food did not have a relevant impact on the bioavailability of linagliptin from the FDC tablet .
CONCLUSIONS	The effect of food on the metformin component was comparable to that previously demonstrated .
CONCLUSIONS	Furthermore , differences in tablet-dissolution characteristics did not have an impact on the bioavailability of linagliptin or metformin from the FDC tablet .

###25452062
OBJECTIVE	Social factors play an important role in quitting smoking in the general population , but relatively little is known about social influences on smoking cessation efforts among individuals with serious mental illness who suffer disproportionately high rates of smoking .
OBJECTIVE	This study examined social factors as predictors of using smoking cessation treatment among adults with serious mental illness .
METHODS	We conducted a secondary analysis of data from a randomized study comparing two versions of a motivational decision support system for smoking cessation treatment including 124 smokers with schizophrenia or severe mood disorders .
METHODS	Hierarchical logistic regression with blocked entry of theoretically linked predictor variables was used to model two types of social influences ( explicit and implicit ) as predictors of using cessation group therapy or smoking cessation medication .
RESULTS	Approximately 31 % of participants initiated smoking cessation treatment during the 2-month follow-up .
RESULTS	Hierarchical logistic regression analyses revealed that over and above demographic and personal factors , implicit social influences ( others ' approval of treatment ) significantly predicted use of smoking cessation medication , while explicit social influences ( smoking with others ) significantly predicted use of cessation group therapy .
CONCLUSIONS	For people with serious mental illness , social factors appear to influence use of smoking cessation treatment above and beyond personal factors and may be specific to the type of treatment .
CONCLUSIONS	These data support the need to further explore the role of social factors as potential leverage points for engagement in smoking cessation treatments in this population .

###24307184
OBJECTIVE	To evaluate 8-year weight losses achieved with intensive lifestyle intervention ( ILI ) in the Look AHEAD ( Action for Health in Diabetes ) study .
METHODS	Look AHEAD assessed the effects of intentional weight loss on cardiovascular morbidity and mortality in 5,145 overweight/obese adults with type 2 diabetes , randomly assigned to ILI or usual care ( i.e. , diabetes support and education [ DSE ] ) .
METHODS	The ILI provided comprehensive behavioral weight loss counseling over 8 years ; DSE participants received periodic group education only .
RESULTS	All participants had the opportunity to complete 8 years of intervention before Look AHEAD was halted in September 2012 ; 88 % of both groups completed the 8-year outcomes assessment .
RESULTS	ILI and DSE participants lost ( mean SE ) 4.7 % 0.2 % and 2.1 0.2 % of initial weight , respectively ( P < 0.001 ) at year 8 ; 50.3 % and 35.7 % , respectively , lost 5 % ( P < 0.001 ) , and 26.9 % and 17.2 % , respectively , lost 10 % ( P < 0.001 ) .
RESULTS	Across the 8 years ILI participants , compared with DSE , reported greater practice of several key weight-control behaviors .
RESULTS	These behaviors also distinguished ILI participants who lost 10 % and kept it off from those who lost but regained .
CONCLUSIONS	Look AHEAD 's ILI produced clinically meaningful weight loss ( 5 % ) at year 8 in 50 % of patients with type 2 diabetes and can be used to manage other obesity-related co-morbid conditions .

###24500661
BACKGROUND	Intraocular pressure is increased during laparoscopic surgeries performed in a steep Trendelenburg position .
BACKGROUND	This study compared the effects of propofol with those of sevoflurane on intraocular pressure in patients undergoing robot-assisted laparoscopic radical prostatectomy in a 30 Trendelenburg position .
METHODS	Sixty-six patients were randomly allocated to a maintenance anesthetic consisting of remifentanil and sevoflurane ( Sevoflurane Group ) or remifentanil and propofol ( Propofol Group ) .
METHODS	Intraocular pressure ( IOP ) was measured at nine predefined time points , including baseline ( T0 ) , five minutes after establishing pneumoperitoneum ( T2 ) , 30min after establishing the Trendelenburg position with pneumoperitoneum ( T3 ) , five minutes after returning to the horizontal position ( T4 ) , and immediately after tracheal extubation ( T6 ) .
METHODS	The primary outcome was the change in intraocular pressure from T0 to T3 .
RESULTS	The results of linear mixed model analysis showed that intraocular pressure differed between the two groups ( P = 0.0039 ) .
RESULTS	At T3 , the mean ( SD ) IOP was greater in the Sevoflurane Group [ 23.5 ( 4.3 ) mmHg ] than in the Propofol Group [ 19.9 ( 3.8 ) mmHg ] ( P = 0.0019 ) .
RESULTS	At T2 and T6 , IOP was also greater in the Sevoflurane Group than in the Propofol Group ( P = 0.038 and P = 0.009 , respectively ) .
RESULTS	There was a statistically significant increase in intraocular pressure from baseline to T3 ( pneumoperitoneum and steep Trendelenberg ) in the Sevoflurane Group [ 6.0 ( 5.0 ) mmHg ; P < 0.001 ] but not in the Propofol Group [ 2.1 ( 5.1 ) mmHg ; P = 0.136 ] .
RESULTS	None of the patients experienced ocular complications .
CONCLUSIONS	Intraocular pressure increases after pneumoperitoneum and the steep Trendelenburg position are established .
CONCLUSIONS	This increase is less with propofol than with sevoflurane anesthesia .
CONCLUSIONS	This trial was registered at ClinicalTrials.gov : NCT01744262 .

###24757032
OBJECTIVE	Enhancing exercise adherence over the longer term is an important goal in self-management of knee osteoarthritis ( OA ) .
OBJECTIVE	Following an initial period of more intensive exercise supervision , this study investigated whether 2 additional physiotherapy visits improved outcomes with continued home exercise over a subsequent 24-week period .
METHODS	A total of 78 people with medial knee OA ( mean SD age 62.1 6.9 years , mean SD body mass index 29.4 4.0 kg/m ( 2 ) , and radiographic disease severity 19 % mild , 49 % moderate , and 32 % severe ) who completed a 12-week physiotherapist-supervised exercise trial were randomly allocated to 2 30-minute physiotherapy booster sessions ( delivered by 8 physiotherapists in private clinics ) or no booster sessions for the subsequent 24 weeks .
METHODS	All participants were asked to continue home exercises 4 times weekly .
METHODS	Primary outcomes were change in pain , using a 100-mm visual analog scale , and self-reported physical function , measured using the Western Ontario McMaster Universities Osteoarthritis Index .
METHODS	Participants and physiotherapists were unblinded to group allocation , although participants were blinded to the study hypothesis .
RESULTS	A total of 74 participants ( 95 % ) completed the trial .
RESULTS	There was no significant difference between groups for change in pain ( mean difference [ 95 % confidence interval ( 95 % CI ) ] 0.7 mm [ -9.4 , 8.0 ] ; P = 0.88 ) or physical function ( -0.3 units [ 95 % CI -4.0 , 3.5 ] ; P = 0.88 ) .
RESULTS	The mean SD percentage of home exercise sessions completed was 56 % 34 % in the booster group and 51 % 37 % in the control group ( P > 0.05 ) .
CONCLUSIONS	Two booster sessions with a physiotherapist did not influence pain or physical function outcomes , or measures of home exercise adherence .
CONCLUSIONS	These findings suggest other more effective strategies are needed to maximize longer-term adherence with the aim to achieve greater improvements in clinical outcomes from exercise in this patient population .

###24725308
BACKGROUND	Heart failure is a prevalent health problem associated with costly hospital readmissions .
BACKGROUND	Transitional care programs have been shown to reduce readmissions but are costly to implement .
BACKGROUND	Evidence regarding the effectiveness of telemonitoring in managing the care of this chronic condition is mixed .
BACKGROUND	The objective of this randomized controlled comparative effectiveness study is to evaluate the effectiveness of a care transition intervention that includes pre-discharge education about heart failure and post-discharge telephone nurse coaching combined with home telemonitoring of weight , blood pressure , heart rate , and symptoms in reducing all-cause 180-day hospital readmissions for older adults hospitalized with heart failure .
METHODS	A multi-center , randomized controlled trial is being conducted at six academic health systems in California .
METHODS	A total of 1,500 patients aged 50years and older will be enrolled during a hospitalization for treatment of heart failure .
METHODS	Patients in the intervention group will receive intensive patient education using the ` teach-back ' method and receive instruction in using the telemonitoring equipment .
METHODS	Following hospital discharge , they will receive a series of nine scheduled health coaching telephone calls over 6months from nurses located in a centralized call center .
METHODS	The nurses also will call patients and patients ' physicians in response to alerts generated by the telemonitoring system , based on predetermined parameters .
METHODS	The primary outcome is readmission for any cause within 180days .
METHODS	Secondary outcomes include 30-day readmission , mortality , hospital days , emergency department ( ED ) visits , hospital cost , and health-related quality of life .
CONCLUSIONS	BEAT-HF is one of the largest randomized controlled trials of telemonitoring in patients with heart failure , and the first explicitly to adapt the care transition approach and combine it with remote telemonitoring .
CONCLUSIONS	The study population also includes patients with a wide range of demographic and socioeconomic characteristics .
CONCLUSIONS	Once completed , the study will be a rich resource of information on how best to use remote technology in the care management of patients with chronic heart failure .
BACKGROUND	ClinicalTrials.gov # NCT01360203 .

###24729409
OBJECTIVE	Chemosaturation with percutaneous hepatic perfusion ( PHP ; Hepatic CHEMOSAT ( ) Delivery System ; Delcath Systems Inc , USA ) is a minimally invasive , repeatable regional therapy for unresectable hepatic metastases .
OBJECTIVE	It uses a system of catheters and filters to isolate hepatic venous blood from the systemic circulation , allowing delivery of high-dose chemotherapy to the hepatic artery .
OBJECTIVE	Effluent hepatic venous blood is filtered before being returned to the systemic circulation , thereby reducing exposure to chemotherapy .
OBJECTIVE	We describe our experiences with chemosaturation-PHP at 2 European centers .
METHODS	14 patients presented unresectable hepatic metastases from solid tumors ; 13 received 1-3 sessions of chemosaturation-PHP .
METHODS	Melphalan 2.0 ( n = 1 ) or 3.0 ( n = 12 ) mg/kg was given as a 30-minute infusion into the hepatic artery .
METHODS	12 patients were evaluable for tumor response .
RESULTS	One complete ( cholangiocarcinoma , n = 1 ) and 6 partial responses ( ocular , n = 3 or cutaneous melanoma , n = 3 ) were observed , 5 patients had stable disease ( ocular melanoma , n = 3 ; breast cancer , n = 1 ; gastric cancer , n = 1 ) .
RESULTS	Mild to moderate filter-related toxicity ( i.e. thrombocytopenia , anemia ) was observed immediately post-procedure .
RESULTS	Grade 3/4 melphalan-related pancytopenia developed after 1-2 weeks .
RESULTS	All hematological events were managed effectively with transfusions and/or other supportive measures .
RESULTS	The new high-efficiency filter showed milder toxicity and faster recovery .
RESULTS	In one case , chemosaturation-PHP was abandoned prematurely due to heparin-induced vaginal bleeding , and one patient died due to retroperitoneal hemorrhage from heparin anti-coagulation .
CONCLUSIONS	Chemosaturation-PHP for non-resectable liver metastases is a feasible treatment option when performed by an experienced multi-disciplinary team .
CONCLUSIONS	It may be a promising regional therapy for patients with no effective treatment options .

###25566971
BACKGROUND	The perspectives and experiences of trial staff are increasingly being investigated as these can be used to improve recruitment , adherence to trial protocols and support given to future staff .
BACKGROUND	We interviewed staff working on a type 1 diabetes trial in order to aid interpretation of trial findings , inform recommendations for the rollout of the treatments investigated and provide recommendations for the conduct of future trials .
BACKGROUND	However , our interviews uncovered aspects of trial work erstwhile unrecognised or underreported in the trials literature , and it is these which form the focus of this paper .
METHODS	In-depth interviews were conducted with ( n = 18 ) staff , recruited from seven centres , who were involved in recruitment and trial delivery .
METHODS	Data were analysed thematically .
RESULTS	Alongside logistical and practical issues which made trial work challenging , staff often talked spontaneously and at length about how trial work had affected them emotionally .
RESULTS	Staff not only described the emotional stresses arising from having to meet recruitment targets and from balancing research roles with clinical responsibilities , they also discussed having to emotionally manage patients and their colleagues .
RESULTS	The emotional aspects of trial work particularly came to the fore when staff notified patients about their treatment allocation .
RESULTS	On such occasions , staff described having to employ emotional strategies to pre-empt and manage potential patient disappointment and anger .
RESULTS	Staff also described having to manage their own emotions when patients withdrew from the trial or were not randomised to the treatment arm which , in their clinical judgment , would have been in their best interests .
RESULTS	To help address the emotional challenges they encountered , staff highlighted a need for more practical , emotional and specialist psychological support .
CONCLUSIONS	More attention should be paid to the emotional aspects of trial work to help ensure trial staff are adequately supported .
CONCLUSIONS	Such support could comprise : increased training for staff to improve their own and patients ' understandings of randomization , role-play to develop techniques to manage patient anger and disappointment , sharing of good practice , formalised team support with psychological input and access to specialist psychological support to troubleshoot complex emotional and ethical issues .

###25945662
BACKGROUND	Motion sickness is an unpleasant physiological state that may be controlled via nonpharmacological methods .
BACKGROUND	Controlled breathing has been shown to maximize parasympathetic nervous system ( PNS ) tone and may have the ability to decrease motion sickness symptoms .
METHODS	The effects of slow diaphragmatic breathing ( DB ) in a motion sickness-inducing environment were examined within motion sickness susceptible individuals .
METHODS	Subjects ( N = 43 ) were assigned randomly to either an experimental group trained in slow DB or a control group breathing naturally at a normal pace .
METHODS	The experimental group was trained using a digital video that helped them pace their diaphragmatic breathing at six breaths/min .
METHODS	During the study , subjects viewed a virtual reality ( VR ) experience of a boat in rough seas for 10 min .
METHODS	Motion sickness ratings along with heart rate and respiration rate were collected before , during , and after the VR experience .
RESULTS	Results indicated that the experimental group was able to decrease their breathing to eight breaths/min during the VR experience .
RESULTS	This breathing rate was significantly slower than those in the control group .
RESULTS	We found that DB subjects , compared to those in the control group , displayed significantly greater heart rate variability and reported feeling less motion sickness during exposure to the VR experience than those in the control group .
CONCLUSIONS	Results indicate possible benefits of using slow DB techniques in a motion sickness inducing environment .

###24988909
BACKGROUND	The sore throat pain model has been conducted by different clinical investigators to demonstrate the efficacy of acute analgesic drugs in single-dose randomized clinical trials .
BACKGROUND	The model used here was designed to study the multiple-dose safety and efficacy of lozenges containing flurbiprofen at 8.75 mg .
METHODS	Adults ( n = 198 ) with moderate or severe acute sore throat and findings of pharyngitis on a Tonsillo-Pharyngitis Assessment ( TPA ) were randomly assigned to use either flurbiprofen 8.75 mg lozenges ( n = 101 ) or matching placebo lozenges ( n = 97 ) under double-blind conditions .
METHODS	Patients sucked one lozenge every three to six hours as needed , up to five lozenges per day , and rated symptoms on 100-mm scales : the Sore Throat Pain Intensity Scale ( STPIS ) , the Difficulty Swallowing Scale ( DSS ) , and the Swollen Throat Scale ( SwoTS ) .
RESULTS	Reductions in pain ( lasting for three hours ) and in difficulty swallowing and throat swelling ( for four hours ) were observed after a single dose of the flurbiprofen 8.75 mg lozenge ( P < 0.05 compared with placebo ) .
RESULTS	After using multiple doses over 24 hours , flurbiprofen-treated patients experienced a 59 % greater reduction in throat pain , 45 % less difficulty swallowing , and 44 % less throat swelling than placebo-treated patients ( all P < 0.01 ) .
RESULTS	There were no serious adverse events .
CONCLUSIONS	Utilizing the sore throat pain model with multiple doses over 24 hours , flurbiprofen 8.75 mg lozenges were shown to be an effective , well-tolerated treatment for sore throat pain .
CONCLUSIONS	Other pharmacologic actions ( reduced difficulty swallowing and reduced throat swelling ) and overall patient satisfaction from the flurbiprofen lozenges were also demonstrated in this multiple-dose implementation of the sore throat pain model .
BACKGROUND	This trial was registered with ClinicalTrials.gov , registration number : NCT01048866 , registration date : January 13 , 2010 .

###25017958
OBJECTIVE	The aim of this randomized trial was to compare short-term postoperative complications of laparoscopic transabdominal preperitoneal ( TAPP ) and Lichtenstein tension free hernia repair .
METHODS	A total of 120 patients who went inguinal hernia repair at Shahid Sadoughi university training hospital from April 2011 to August 2013 were randomized into two TAPP ( N. = 60 ) and Lichtenstein ( N. = 60 ) repair group .
METHODS	Follow-up occurred within 6 weeks .
METHODS	The postoperative assessments included pain score ( VAS ) , hematoma/seroma , urinary retention , wound infection incidence , and duration of hospital stay .
RESULTS	Pain was the most common symptoms in both groups .
RESULTS	The TAPP group patients significantly had experienced less postoperative pain than the Lichtenstein group in all moments ( P < 0.05 ) .
RESULTS	TAPP group had lower incidence of hematoma ( TAPP , 6.6 % vs. Lichtenstein 13.3 % ; P = 0.67 ) , seroma ( TAPP 10 % vs. Lichtenstein 13.3 % ; P = 1.00 ) , and infection ( TAPP 0 vs. Lichtenstein 1.6 % ; P = 0.67 ) .
RESULTS	However , no differences between the 2 groups were found in terms of postoperative complications .
RESULTS	In TAPP group mean of hospital stay significantly was less than Lichtenstein group ( TAPP , 8.132.19 vs. Lichtenstein , 13.151.5 days ; P < 0.001 ) .
CONCLUSIONS	The laparoscopic TAPP repair is safer and less complicated approach to inguinal hernia repair .
CONCLUSIONS	The two main short-term advantages of the laparoscopic TAPP repair with the tension free Lichtenstein repair were less postoperative pain and earlier return to the normal life activities .
CONCLUSIONS	No difference was seen in overall complications .

###24909399
OBJECTIVE	To assess whether bipolar transurethral resection of the prostate ( B-TURP ) using the TURis system has a similar level of efficacy and safety to that of the traditional monopolar transurethral resection of the prostate ( M-TURP ) , and to evaluate the impact of the TURis system on postoperative urethral stricture rates over a 36-month follow-up period .
METHODS	A total of 136 patients with benign prostatic obstruction were randomised to undergo either B-TURP using the TURis system or conventional M-TURP , and were regularly followed for 36 months after surgery .
METHODS	The primary endpoint was safety , which included the long-term complication rates of postoperative urethral stricture .
METHODS	The secondary endpoint was the follow-up measurement of efficacy .
RESULTS	In peri-operative findings , no patient in either treatment group presented with transurethral resection syndrome , and the decline in levels of haemoglobin and hematocrit were similar .
RESULTS	The mean operation time was significantly extended in the TURis treatment group compared with the M-TURP group ( 79.5 vs 68.6 min ; P = 0.032 ) and postoperative clot retention was more likely to be seen after M-TURP ( P = 0.044 ) .
RESULTS	Similar efficacy findings were maintained throughout 36 months , but a significant difference in postoperative urethral stricture rates between groups was detected ( 6.6 % in M-TURP vs 19.0 % in TURis ; P = 0.022 ) .
RESULTS	After stratifying patients according to prostate volume , there was no significant difference between the two treatment groups with regard to urethral stricture rates in patients with a prostate volume 70mL ( 3.8 % in M-TURP vs 3.8 % in TURis ) , but in the TURis group there was a significantly higher urethral stricture rate compared with the M-TURP group in patients with a prostate volume > 70mL ( 20 % in TURis vs 2.2 % in M-TURP ; P = 0.012 ) .
RESULTS	Furthermore , the mean operation time for TURis was significantly longer than for M-TURP for the subgroup of patients with a prostate volume > 70mL ( 99.6 vs 77.2 min ; P = 0.011 ) , but not for the subgroup of patients with a prostate volume 70mL .
CONCLUSIONS	The TURis system seems to be as efficacious and safe as conventional M-TURP except that there was a higher incidence of urethral stricture in patients with larger preoperative prostate volumes .

###26295638
OBJECTIVE	The gadolinium-based MRI contrast agent gadobenate dimeglumine has nearly twice the MR relaxivity of gadopentetate dimeglumine at 1.5 T.
OBJECTIVE	The purpose of this study was to determine whether a lower dose ( 0.1 mmol/kg ) of gadobenate dimeglumine can be used to obtain delayed-enhancement MR images comparable to those obtained with a standard dose ( 0.2 mmol/kg ) of gadopentetate dimeglumine .
METHODS	In this blinded randomized crossover study , 20 patients with known myocardial infarction underwent two separate delayed-enhancement MRI examinations after receiving 0.1 mmol/kg gadobenate dimeglumine and 0.2 mmol/kg gadopentetate dimeglumine ( random administration ) .
METHODS	The conspicuity of lesion enhancement 5 , 10 , and 20 minutes after contrast administration was quantified as relative enhancement ratio ( RER ) .
RESULTS	With either gadolinium-based contrast agent , damaged myocardium had higher signal intensity than normal remote myocardium ( RER > 4 ) on delayed-enhancement MR images , and the blood RER declined over time after contrast administration .
RESULTS	The blood RER was not significantly higher for gadobenate dimeglumine than for gadopentetate dimeglumine at 5 and 10 minutes .
RESULTS	Nevertheless , there was a larger reduction in blood RER for gadobenate dimeglumine than for gadopentetate dimeglumine between 5 and 10 minutes and between 10 and 20 minutes .
RESULTS	The volumes of enhancement were similar for gadobenate dimeglumine ( 13.6 8.8 cm ( 3 ) ) and gadopentetate dimeglumine ( 13.5 8.9 cm ( 3 ) ) ( p = 0.98 ) .
RESULTS	The mean difference in Bland-Altman analysis for delayed-enhancement volume between the agents was 0.1 cm ( 3 ) .
CONCLUSIONS	Qualitatively and quantitatively , delayed-enhancement MR images of ischemic myocardium obtained with 0.1 mmol/kg gadobenate dimeglumine are comparable to those obtained with 0.2 mmol/kg gadopentetate dimeglumine 5 , 10 , and 20 minutes after contrast administration .

###24834933
CONCLUSIONS	The ocular vestibular-evoked myogenic potential ( oVEMP ) test yields the same information as the rotational test in sleep-deprived subjects as evidenced by increased vestibulo-ocular reflex ( VOR ) asymmetry .
CONCLUSIONS	However , the duration of sleep deprivation ( 12 h ) and testing time required for the oVEMP test are shorter than for the rotational test .
OBJECTIVE	This study utilized the oVEMP test in sleep-deprived subjects to investigate the effect of short-duration sleep deprivation on the VOR system .
METHODS	Twenty healthy resident physicians underwent oVEMP and cervical VEMP ( cVEMP ) tests twice in a randomized order ; one test battery was performed after a normal sleep , and the other was performed after a night duty at the emergency service , which meant a state of 12 h sleep deprivation .
RESULTS	All 20 subjects had clear oVEMPs regardless of whether testing was performed after a normal sleep or 12 h sleep deprivation condition .
RESULTS	Significant differences were not identified between the two sleep conditions in terms of characteristic parameters , i.e. latencies and amplitude of oVEMPs .
RESULTS	However , the mean asymmetry ratio after sleep deprivation ( 20 13 % ) was significantly larger than that after normal sleep ( 8 12 % ) .
RESULTS	Conversely , the cVEMP parameters did not differ significantly between the two sleep conditions .

###24755206
BACKGROUND	Peer-led interventions to improve chronic disease self-management can improve health outcomes but are not widely used .
BACKGROUND	Therefore , we tested a peer-led hypertension self-management intervention delivered at regular meetings of community veterans ' organizations .
METHODS	We randomized 58 organizational units ( `` posts '' ) of veterans ' organizations in southeast Wisconsin to peer-led vs. professionally delivered self-management education .
METHODS	Volunteer peer leaders at peer-led posts delivered monthly presentations regarding hypertension self-management during regular post meetings .
METHODS	Volunteer post representatives at seminar posts encouraged post members to attend 3 didactic seminars delivered by health professionals at a time separate from the post meeting .
METHODS	Volunteers in both groups encouraged members to self-monitor using blood pressure cuffs , weight scales , and pedometers .
METHODS	Our primary outcome was change in systolic blood pressure ( SBP ) at 12 months .
RESULTS	We measured SBP in 404 participants at baseline and in 379 participants at 12 months .
RESULTS	SBP decreased significantly ( 4.4 mm Hg ; P < 0.0001 ) overall ; the decrease was similar in peer-led and seminar posts ( 3.5 mm Hg vs. 5.4 mm Hg ; P = 0.24 ) .
RESULTS	Among participants with uncontrolled BP at baseline , SBP decreased by 10.1 mm Hg from baseline to 12 months but was again similar in the 2 groups .
RESULTS	This pattern was also seen at 6 months and with diastolic blood pressure .
CONCLUSIONS	Our peer-led educational intervention was not more effective than didactic seminars for SBP control .
CONCLUSIONS	Although peer-led educational programs have had important impacts in a number of studies , we did not find our intervention superior to a similar intervention delivered by healthcare professionals .
BACKGROUND	ClinicalTrials.gov NCT00571038 .

###24428466
BACKGROUND	Pritelivir , an inhibitor of the viral helicase-primase complex , exhibits antiviral activity in vitro and in animal models of herpes simplex virus ( HSV ) infection .
BACKGROUND	We tested the efficacy and safety of pritelivir in otherwise healthy persons with genital HSV-2 infection .
METHODS	We randomly assigned 156 HSV-2-positive persons with a history of genital herpes to receive one of four doses of oral pritelivir ( 5 , 25 , or 75 mg daily , or 400 mg weekly ) or placebo for 28 days .
METHODS	Participants obtained daily swabs from the genital area for HSV-2 testing , which was performed with a polymerase-chain-reaction assay .
METHODS	Participants also maintained a diary of genital signs and symptoms .
METHODS	The primary end point was the rate of genital HSV shedding .
RESULTS	HSV shedding among placebo recipients was detected on 16.6 % of days ; shedding among pritelivir recipients was detected on 18.2 % of days among those receiving 5 mg daily , 9.3 % of days among those receiving 25 mg daily , 2.1 % of days among those receiving 75 mg daily , and 5.3 % of days among those receiving 400 mg weekly .
RESULTS	The relative risk of viral shedding with pritelivir , as compared with placebo , was 1.11 ( 95 % confidence interval [ CI ] , 0.65 to 1.87 ) with the 5-mg daily dose , 0.57 ( 95 % CI , 0.31 to 1.03 ) with the 25-mg daily dose , 0.13 ( 95 % CI , 0.04 to 0.38 ) with the 75-mg daily dose , and 0.32 ( 95 % CI , 0.17 to 0.59 ) with the 400-mg weekly dose .
RESULTS	The percentage of days with genital lesions was also significantly reduced , from 9.0 % in the placebo group to 1.2 % in both the group receiving 75 mg of pritelivir daily ( relative risk , 0.13 ; 95 % CI , 0.02 to 0.70 ) and the group receiving 400 mg weekly ( relative risk , 0.13 ; 95 % CI , 0.03 to 0.52 ) .
RESULTS	The rate of adverse events was similar in all groups .
CONCLUSIONS	Pritelivir reduced the rates of genital HSV shedding and days with lesions in a dose-dependent manner in otherwise healthy men and women with genital herpes .
CONCLUSIONS	( Funded by AiCuris ; ClinicalTrials.gov number , NCT01047540 . )

###24667461
OBJECTIVE	To test the hypothesis that the simultaneous administration of GLP-1 and insulin may increase their vasodilatory , antiinflammatory , and antioxidant action in type 2 diabetes .
METHODS	In two groups of persons with type 2 diabetes , two sets of experiments were performed .
METHODS	The first group had two normoglycemic-normoinsulinemic clamps with or without GLP-1 and two normoglycemic-hyperinsulinemic clamps with or without GLP-1 .
METHODS	The second group had two hyperglycemic-normoinsulinemic clamps and two hyperglycemic-hyperinsulinemic clamps with or without GLP-1 .
RESULTS	During the normoglycemic-hyperinsulinemic clamp , flow-mediated dilatation ( FMD ) increased , while soluble intercellular adhesion molecule ( sICAM-1 ) , plasma 8-iso-prostaglandin F2 ( 8-iso-PGF2 ) , nitrotyrosine , and interleukin ( IL ) -6 decreased compared with normoglycemic-normoinsulinemic clamp .
RESULTS	Similar results were obtained with the infusion of GLP-1 during the normoglycemic-normoinsulinemic clamp .
RESULTS	The combination of hyperinsulinemia and GLP-1 in normoglycemia was accompanied by a further FMD increase and sICAM-1 , 8-iso-PGF2 , nitrotyrosine , and IL-6 decrease .
RESULTS	During the hyperglycemic-normoinsulinemic clamp , FMD significantly decreased , while sICAM-1 , 8-iso-PGF2 , nitrotyrosine , and IL-6 significantly increased .
RESULTS	When hyperglycemia was accompanied by hyperinsulinemia or by the simultaneous infusion of GLP-1 , these phenomena were attenuated .
RESULTS	The simultaneous presence of hyperinsulinemia and GLP-1 had an increased beneficial effect .
CONCLUSIONS	Our results show that the combination of insulin and GLP-1 is more effective than insulin or GLP-1 alone in improving endothelial dysfunction , inflammation , and oxidative stress in type 2 diabetes .

###25249191
OBJECTIVE	Examine the effect of an early intervention programme on cognitive outcome at 7 and 9years in children with birth weight ( BW ) < 2000g .
METHODS	A randomised controlled trial of a modified version of the Mother-Infant Transaction Program .
METHODS	A single tertiary neonatal unit .
METHODS	146 infants were randomised into a preterm control group ( 74 ) or a preterm intervention group ( 72 ) .
METHODS	The intervention consisted of eight sessions shortly before discharge and four home visits by specially trained nurses focusing on the infants ' unique characteristics , temperament , developmental potential and the interaction between infants and parents .
METHODS	Outcomes were assessed with the Wechsler Intelligence Scale for Children ( WISC-III ) .
RESULTS	Mean BWs were 1396 ( 429 ) g in the intervention group and 1381 ( 436 ) g in the control group .
RESULTS	After adjusting for the possible clustering effects of twin pairs and maternal education , there were no significant differences in WISC-III scores at age 7 or 9 .
RESULTS	The mean difference was 4.1 points ( 95 % CI -1.5 to 9.8 points ) in favour of the intervention group at 7years and 2.2 points ( 95 % CI -3.4 to 7.6 points ) at 9years .
RESULTS	At 7years , a 6.8 points difference in the Verbal Comprehension Index ( 95 % CI 0.5 to 13.0 points ) was found in favour of the intervention group .
RESULTS	Loss to follow-up at age 7 and 9 was 11 % and 14 % , respectively .
CONCLUSIONS	This intervention programme did not have a sustained significant effect on overall cognitive outcomes in preterm children at age 7 and 9 .
BACKGROUND	The trial has been registered at http://www.clinicaltrials.gov ( identifier NCT00222456 ) .

###24257146
BACKGROUND	Local analgesia through wound catheters is used as a part of multimodal analgesia .
BACKGROUND	The efficacy of continuous subfascial wound infusion compared to epidural analgesia is unknown for abdominal hysterectomy and bilateral salpingo-oophorectomy ( TAH-BSO ) via Pfannenstiel incision .
BACKGROUND	The aim of this study was to compare the aforementioned two methods in this type of surgery for postoperative morphine consumption , acute and persistent postsurgical pain .
METHODS	Fifty patients enrolled in the study were randomly allocated to receive continuous 10 mL/h levobupivacaine either via subfascial ( Group S ) or epidural ( Group E ) catheter for 48 h postoperatively .
METHODS	In Group S 0.25 % levobupivacaine was used for the first six hours and 0.125 % thereafter , whereas Group E received 0.125 % levobupivacaine throughout the study period .
METHODS	Cumulative morphine consumption , static and dynamic pain , gastrointestinal recovery , ambulation , patient satisfaction , hospital stay , as well as pain at 2nd and 6th months were evaluated .
RESULTS	Group S was superior to Group E regarding cumulative morphine consumption ( 16.87.2 mg and 28.710.3 mg respectively , P < 0.001 ; mean difference -11.9 with 95 % CI of the difference -17.1 to -6.7 ) and pain relief .
RESULTS	Patient satisfaction was higher in Group S compared to Group E ( P = 0.006 ) .
RESULTS	Less postoperative vomiting was observed in Group S. No difference was detected in length of hospital stay and persistent postsurgical pain incidence .
CONCLUSIONS	Wound analgesia via subfascial catheter with continuous levobupivacaine infusion decreases postoperative morphine consumption and increases patient satisfaction compared to epidural analgesia with no difference in persistent postsurgical pain following TAH-BSO via Pfannenstiel incision .

###24447459
BACKGROUND	This study evaluates the effects of an intervention performed by youth health care professionals on child health behaviors .
BACKGROUND	The intervention consisted of offering healthy lifestyle counseling to parents of overweight ( not obese ) 5-year-old children .
BACKGROUND	Effects of the intervention on the child having breakfast , drinking sweet beverages , watching television and playing outside were evaluated .
METHODS	Data were collected with the ` Be active , eat right ' study , a cluster randomized controlled trial among nine youth health care centers in the Netherlands .
METHODS	Parents of overweight children received lifestyle counseling according to the intervention protocol in the intervention condition ( n = 349 ) and usual care in the control condition ( n = 288 ) .
METHODS	Parents completed questionnaires regarding demographic characteristics , health behaviors and the home environment at baseline and at 2-year follow-up .
METHODS	Cluster adjusted regression models were applied ; interaction terms were explored .
RESULTS	The population for analysis consisted of 38.1 % boys ; mean age 5.8 [ sd 0.4 ] years ; mean BMI SDS 1.9 [ sd 0.4 ] .
RESULTS	There were no significant differences in the number of minutes of outside play or television viewing a day between children in the intervention and the control condition .
RESULTS	Also , the odds ratio for having breakfast daily or drinking two or less glasses of sweet beverages a day showed no significant differences between the two conditions .
RESULTS	Additional analyses showed that the odds ratio for drinking less than two glasses of sweet beverages at follow-up compared with baseline was significantly higher for children in both the intervention ( p < 0.001 ) and the control condition ( p = 0.029 ) .
CONCLUSIONS	Comparison of the children in the two conditions showed that the intervention does not contribute to a change in health behaviors .
CONCLUSIONS	Further studies are needed to investigate opportunities to adjust the intervention protocol , such as integration of elements in the regular well-child visit .
CONCLUSIONS	The intervention protocol for youth health care may become part of a broader approach to tackle childhood overweight and obesity .
BACKGROUND	Current Controlled Trials ISRCTN04965410 .

###24629036
BACKGROUND	Current practice in the delivery of caloric intake ( DCI ) in patients with severe acute kidney injury ( AKI ) receiving renal replacement therapy ( RRT ) is unknown .
BACKGROUND	We aimed to describe calorie administration in patients enrolled in the Randomized Evaluation of Normal vs. Augmented Level of Replacement Therapy ( RENAL ) study and to assess the association between DCI and clinical outcomes .
METHODS	We performed a secondary analysis in 1456 patients from the RENAL trial .
METHODS	We measured the dose and evolution of DCI during treatment and analyzed its association with major clinical outcomes using multivariable logistic regression , Cox proportional hazards models , and time adjusted models .
RESULTS	Overall , mean DCI during treatment in ICU was low at only 10.99 Kcal/kg/day for non-survivors and 119 Kcal/kg/day for survivors .
RESULTS	Among patients with a lower DCI ( below the median ) 334 of 729 ( 45.8 % ) had died at 90-days after randomization compared with 316 of 727 ( 43.3 % ) patients with a higher DCI ( above the median ) ( P = 0.34 ) .
RESULTS	On multivariable logistic regression analysis , mean DCI carried an odds ratio of 0.95 ( 95 % confidence interval ( CI ) : 0.91-1 .00 ; P = 0.06 ) per 100 Kcal increase for 90-day mortality .
RESULTS	DCI was not associated with significant differences in renal replacement ( RRT ) free days , mechanical ventilation free days , ICU free days and hospital free days .
RESULTS	These findings remained essentially unaltered after time adjusted analysis and Cox proportional hazards modeling .
CONCLUSIONS	In the RENAL study , mean DCI was low .
CONCLUSIONS	Within the limits of such low caloric intake , greater DCI was not associated with improved clinical outcomes .
BACKGROUND	ClinicalTrials.gov number , NCT00221013 .

###26210844
OBJECTIVE	To develop a clinically valid interactive level 2 screening assessment for autism spectrum disorders ( ASD ) in toddlers that is brief , easily administered , and scored by clinicians .
METHODS	We describe the development , training , standardization , and validation of the Rapid Interactive Screening Test for Autism in Toddlers ( RITA-T ) with ASD-specific diagnostic instruments .
METHODS	The RITA-T can be administered and scored in 10 minutes .
METHODS	We studied the validity of the RITA-T to distinguish between toddlers with ASD from toddlers with developmental delay ( DD ) / non-ASD in an early childhood clinic .
METHODS	We also evaluated the test 's performance in toddlers with no developmental concerns .
METHODS	We identified a cutoff score based on sensitivity , specificity , and positive predictive value of the RITA-T that best differentiates between ASD and DD/non-ASD .
RESULTS	A total of 61 toddlers were enrolled .
RESULTS	RITA-T scores were correlated with ASD-specific diagnostic tools ( r = 0.79 ; P < .01 ) and ASD clinical diagnoses ( r = 0.77 ; P < .01 ) .
RESULTS	Mean scores were significantly different in subjects with ASD , those with DD/non-ASD , and those with no developmental concerns ( 20.8 vs 13 vs 10.6 , respectively ; P < .0001 ) .
RESULTS	At a cutoff score of > 14 , the RITA-T had a sensitivity of 1.00 , specificity of 0.84 , and positive predictive value of 0.88 for identifying ASD risk in a high-risk group .
CONCLUSIONS	The RITA-T is a promising new level 2 interactive screening tool for improving the early identification of ASD in toddlers in general pediatric and early intervention settings and allowing access to treatment .

###25270545
BACKGROUND	Despite the great variety of mammaplasty techniques , outcome assessment remains a challenging issue .
OBJECTIVE	The authors devised an objective method to evaluate mammary symmetry based on statistical analysis of objective manual breast measurements and validated the method by applying it to results of a randomized controlled trial on the correction of breast asymmetry .
METHODS	Sixty consecutive patients with hypoplastic breasts and small-volume asymmetry were enrolled in the study and randomly assigned to 1 of 2 groups .
METHODS	One group received a fixed-volume implant in 1 breast and an adjustable-volume implant in the other .
METHODS	The other group received 2 fixed-volume implants of different sizes .
METHODS	The differences in specific breast and chest measurements , obtained before surgery and during follow-up , were analyzed statistically with the Wilcoxon signed rank test .
RESULTS	Correction of the asymmetry resulted in the reduction of the differences between left and right values for each specific breast measurement .
RESULTS	Placement of an adjustable implant on 1 side yielded better symmetry than placement of 2 fixed-volume prostheses of different sizes .
RESULTS	Patient and physician satisfaction was high for both groups .
CONCLUSIONS	This objective analysis of clinical parameters enables comparing results for different patients in large clinical trials and for the same patient at different follow-up periods .
METHODS	3 .

###24931572
BACKGROUND	The safety and effectiveness of automated glycemic management have not been tested in multiday studies under unrestricted outpatient conditions .
METHODS	In two random-order , crossover studies with similar but distinct designs , we compared glycemic control with a wearable , bihormonal , automated , `` bionic '' pancreas ( bionic-pancreas period ) with glycemic control with an insulin pump ( control period ) for 5 days in 20 adults and 32 adolescents with type 1 diabetes mellitus .
METHODS	The automatically adaptive algorithm of the bionic pancreas received data from a continuous glucose monitor to control subcutaneous delivery of insulin and glucagon .
RESULTS	Among the adults , the mean plasma glucose level over the 5-day bionic-pancreas period was 138 mg per deciliter ( 7.7 mmol per liter ) , and the mean percentage of time with a low glucose level ( < 70 mg per deciliter [ 3.9 mmol per liter ] ) was 4.8 % .
RESULTS	After 1 day of automatic adaptation by the bionic pancreas , the mean ( SD ) glucose level on continuous monitoring was lower than the mean level during the control period ( 13313 vs. 15930 mg per deciliter [ 7.40.7 vs. 8.81.7 mmol per liter ] , P < 0.001 ) and the percentage of time with a low glucose reading was lower ( 4.1 % vs. 7.3 % , P = 0.01 ) .
RESULTS	Among the adolescents , the mean plasma glucose level was also lower during the bionic-pancreas period than during the control period ( 13818 vs. 15727 mg per deciliter [ 7.71.0 vs. 8.71.5 mmol per liter ] , P = 0.004 ) , but the percentage of time with a low plasma glucose reading was similar during the two periods ( 6.1 % and 7.6 % , respectively ; P = 0.23 ) .
RESULTS	The mean frequency of interventions for hypoglycemia among the adolescents was lower during the bionic-pancreas period than during the control period ( one per 1.6 days vs. one per 0.8 days , P < 0.001 ) .
CONCLUSIONS	As compared with an insulin pump , a wearable , automated , bihormonal , bionic pancreas improved mean glycemic levels , with less frequent hypoglycemic episodes , among both adults and adolescents with type 1 diabetes mellitus .
CONCLUSIONS	( Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others ; ClinicalTrials.gov numbers , NCT01762059 and NCT01833988 . )

###24247193
OBJECTIVE	The study aim was to establish the threshold of stretching volume for flexibility enhancement during physical education lessons in secondary school children .
METHODS	Subjects were 239 tenth grade children randomly assigned to four groups ( boys 107 , girls 132 , mean age 15.1 0.4 ) .
METHODS	Children involved in after-school sports were not included in the study .
METHODS	Physical education lessons were performed twice a week for 45 minutes in duration .
METHODS	The intervention lasted for five weeks comprising 10 physical education lessons .
METHODS	Flexibility was determined from sit and reach test before and after intervention .
METHODS	Subjects in group 1 performed standard `` sit and reach '' test of four trials in every physical education lesson ; in group 2 received one stretching exercise of four repetitions ; group 3 received four stretching exercises of four repetitions ; in group 4 no stretching was performed .
RESULTS	Flexibility improvement in group 3 were the greatest ( 21.6 % ; P < 0.05 ) , smaller in group 2 ( 12.6 % , P < 0.05 ) and smallest in 1 group ( 5.1 % , P < 0.05 ) , while control group changes were insignificant ( 1.7 % , P > 0.05 ) .
CONCLUSIONS	The main finding was that single flexibility test performed twice a week for five weeks was sufficient stimulus to increase range of motion in secondary school children .
CONCLUSIONS	Stretching exercises provides exceptional prospects to achieve youths ' improvement since schoolchildren are very sensitive to flexibility training .

###24346102
BACKGROUND	In this phase II study , patients with stage IIIB/IV non-small-cell lung cancer were randomly assigned ( 1:1:1 ) to receive LY293111 ( 200 mg twice daily [ 200 LY293111 ] or 600 mg twice daily [ 600 LY293111 ] ) or placebo for 7 days , followed by concurrent cisplatin ( 75 mg/m2 ; day 1 ) and gemcitabine ( 1250 mg/m2 ; days 1 and 8 ) , every 21 days.The primary endpoint was progression-free survival , ( PFS ) , with 75 % power to detect 33 % improvement compared with placebo ( 5 months ) .
METHODS	Of 200 randomized patients , 195 were treated .
METHODS	Demographics were well balanced across treatment arms : 65 % of the patients were men ; median age was 62 years ; 85 % had stage IV disease ; and patients had an Eastern Cooperative Oncology Group performance status of 0 ( 36 % ) or 1 ( 64 % ) .
RESULTS	The most frequent study drug-related toxicities were nausea , vomiting , and fatigue .
RESULTS	Response rates were similar across treatment arms ( 200 LY293111 : 20 % ; 600 LY293111 : 25 % ; placebo : 31 % ) .
CONCLUSIONS	Median PFS ( 95 % confidence interval ) was not significantly different across treatment arms ( 200 LY293111 : 4.6 months [ 3.2-5 .0 ] ; 600 LY293111 : 5.6 months [ 4.1-6 .8 ] ; placebo : 6.0 months [ 5.2-7 .5 ] ) .
CONCLUSIONS	LY293111 combined with gemcitabine-cisplatin did not increase median PFS compared with placebo plus gemcitabine-cisplatin in patients with non-small-cell lung cancer .

###24471505
BACKGROUND	The alginate-antacid , Gaviscon Double Action ( Gaviscon DA ; Reckitt Benckiser , Slough , UK ) suppresses reflux after meals by creating a gel-like barrier that caps and displaces the acid pocket distal to the oesophago-gastric junction .
BACKGROUND	The effect of Gaviscon DA on reflux and dyspepsia symptoms has not yet been demonstrated with a modern trial design .
OBJECTIVE	A pilot study to assess the efficacy and safety of Gaviscon DA compared with matched placebo for decreasing upper gastrointestinal symptoms in symptomatic gastro-oesophageal reflux disease ( GERD ) patients .
METHODS	A randomised , double-blind , parallel group study was performed in 110 patients with symptoms of GERD .
METHODS	Patients received Gaviscon DA or placebo tablets for 7 consecutive days .
METHODS	The primary endpoint compared the change in overall Reflux Disease Questionnaire ( RDQ ) symptom score ( combined heartburn/regurgitation/dyspepsia ) .
METHODS	Secondary endpoints assessed individual dimensions , GERD dimension ( heartburn and regurgitation ) and overall treatment evaluation ( OTE ) .
RESULTS	There was a greater decrease in overall RDQ symptom score in the Gaviscon DA group compared with the placebo group ( Least Squares Mean difference -0.55 ; P = 0.0033 ) , and for each of the dimensions independently .
RESULTS	Patients in the Gaviscon DA group evaluated their overall treatment response higher than patients in the placebo group [ mean ( standard deviation ) OTE 4.1 ( 2.44 ) vs. 1.9 ( 3.34 ) ; P = 0.0005 ] .
RESULTS	No differences in the incidence of adverse events were observed between treatment groups .
CONCLUSIONS	Gaviscon DA decreases reflux and dyspeptic symptoms in GERD patients compared with matched placebo and has a favourable benefit-risk balance .
CONCLUSIONS	Larger scale clinical investigations of medications targeting the acid pocket are warranted .
CONCLUSIONS	( EudraCT , 2012-002188-84 ) .

###25667240
OBJECTIVE	Polysomnography defines the pathophysiology of obstructive sleep apnea syndrome ( OSAS ) but does not predict some important comorbidities or their response to adenotonsillectomy .
OBJECTIVE	We assessed whether OSAS symptoms , as reflected on the Sleep-Related Breathing Disorders Scale of the Pediatric Sleep Questionnaire ( PSQ ) , may offer clinical predictive value .
METHODS	Baseline and 7-month follow-up data were analyzed from 185 participants ( aged 5-9 years with polysomnographically confirmed OSAS ) in the surgical treatment arm of the multicenter Childhood Adenotonsillectomy Trial .
METHODS	Associations were assessed between baseline PSQ or polysomnographic data and baseline morbidity ( executive dysfunction , behavior , quality of life , sleepiness ) or postsurgical improvement .
RESULTS	At baseline , each 1-SD increase in baseline PSQ score was associated with an adjusted odds ratio that was 3 to 4 times higher for behavioral morbidity , 2 times higher for reduced global quality of life , 6 times higher for reduced disease-specific quality of life , and 2 times higher for sleepiness .
RESULTS	Higher baseline PSQ scores ( greater symptom burden ) also predicted postsurgical improvement in parent ratings of executive functioning , behavior , quality of life , and sleepiness .
RESULTS	In contrast , baseline polysomnographic data did not independently predict these morbidities or their postsurgical improvement .
RESULTS	Neither PSQ nor polysomnographic data were associated with objectively assessed executive dysfunction or improvement at follow-up .
CONCLUSIONS	PSQ symptom items , in contrast to polysomnographic results , reflect subjective measures of OSAS-related impairment of behavior , quality of life , and sleepiness and predict their improvement after adenotonsillectomy .
CONCLUSIONS	Although objective polysomnography is needed to diagnose OSAS , the symptoms obtained during an office visit can offer adjunctive insight into important comorbidities and likely surgical responses .

###25193393
BACKGROUND	Adherence to evidence-based cardiovascular ( CV ) medications after an acute myocardial infarction ( MI ) is low after the first 6 months .
BACKGROUND	The use of fixed-dose combinations ( FDC ) has been shown to improve treatment adherence and risk factor control .
BACKGROUND	However , no previous randomized trial has analyzed the impact of a polypill strategy on adherence in post-MI patients .
OBJECTIVE	The cross-sectional FOCUS ( Fixed-Dose Combination Drug for Secondary Cardiovascular Prevention ) study ( Phase 1 ) aimed to elucidate factors that interfere with appropriate adherence to CV medications for secondary prevention after an acute MI .
OBJECTIVE	Additionally , 695 patients from Phase 1 were randomized into a controlled trial ( Phase 2 ) to test the effect of a polypill ( containing aspirin 100 mg , simvastatin 40 mg , and ramipril 2.5 , 5 , or 10 mg ) compared with the 3 drugs given separately on adherence , blood pressure , and low-density lipoprotein cholesterol , as well as safety and tolerability over a period of 9 months of follow-up .
METHODS	In Phase 1 , a 5-country cohort of 2,118 patients was analyzed .
METHODS	Patients were randomized to either the polypill or 3 drugs separately for Phase 2 .
METHODS	Primary endpoint was adherence to the treatment measured at the final visit by the self-reported Morisky-Green questionnaire ( MAQ ) and pill count ( patients had to meet both criteria for adherence at the in-person visit to be considered adherent ) .
RESULTS	In Phase 1 , overall CV medication adherence , defined as an MAQ score of 20 , was 45.5 % .
RESULTS	In a multivariable regression model , the risk of being nonadherent ( MAQ < 20 ) was associated with younger age , depression , being on a complex medication regimen , poorer health insurance coverage , and a lower level of social support , with consistent findings across countries .
RESULTS	In Phase 2 , the polypill group showed improved adherence compared with the group receiving separate medications after 9 months of follow-up : 50.8 % versus 41 % ( p = 0.019 ; intention-to-treat population ) and 65.7 % versus 55.7 % ( p = 0.012 ; per protocol population ) when using the primary endpoint , attending the final visit with MAQ = 20 and high pill count ( 80 % to 110 % ) combined , to assess adherence .
RESULTS	Adherence also was higher in the FDC group when measured by MAQ alone ( 68 % vs. 59 % , p = 0.049 ) .
RESULTS	No treatment difference was found at follow-up in mean systolic blood pressure ( 129.6 mmHg vs. 128.6 mmHg ) , mean low-density lipoprotein cholesterol levels ( 89.9 mg/dl vs. 91.7 mg/dl ) , serious adverse events ( 23 vs. 21 ) , or death ( 1 , 0.3 % in each group ) .
CONCLUSIONS	For secondary prevention following acute MI , younger age , depression , and a complex drug treatment plan are associated with lower medication adherence .
CONCLUSIONS	Meanwhile , adherence is increased in patients with higher insurance coverage levels and social support .
CONCLUSIONS	Compared with the 3 drugs given separately , the use of a polypill strategy met the primary endpoint for adherence for secondary prevention following an acute MI .
CONCLUSIONS	( Fixed Dose Combination Drug [ Polypill ] for Secondary Cardiovascular Prevention [ FOCUS ] ; NCT01321255 ) .

###25010364
BACKGROUND	The presence of entrapped lung changes the appropriate management of malignant pleural effusion from pleurodesis to insertion of an indwelling pleural catheter .
BACKGROUND	No methods currently exist to identify entrapped lung prior to effusion drainage .
BACKGROUND	Our objectives were to develop a method to identify entrapped lung using tissue movement and deformation ( strain ) analysis with ultrasonography and compare it to the existing technique of pleural elastance ( PEL ) .
METHODS	Prior to drainage , 81 patients with suspected malignant pleural effusion underwent thoracic ultrasound using an echocardiogram machine .
METHODS	Images of the atelectatic lower lobe were acquired during breath hold , allowing motion and strain related to the cardiac impulse to be analyzed using motion mode ( M mode ) and speckle-tracking imaging , respectively .
METHODS	PEL was measured during effusion drainage .
METHODS	The gold-standard diagnosis of entrapped lung was the consensus opinion of two interventional pulmonologists according to postdrainage imaging .
METHODS	Participants were randomly divided into development and validation sets .
RESULTS	Both total movement and strain were significantly reduced in entrapped lung .
RESULTS	Using data from the development set , the area under the receiver-operating curves for the diagnosis of entrapped lung was 0.86 ( speckle tracking ) , 0.79 ( M mode ) , and 0.69 ( PEL ) .
RESULTS	Using respective cutoffs of 6 % , 1 mm , and 19 cm H2O on the validation set , the sensitivity/specificity was 71 % / 85 % ( speckle tracking ) , 50 % / 85 % ( M mode ) , and 40 % / 100 % ( PEL ) .
CONCLUSIONS	This novel ultrasound technique can identify entrapped lung prior to effusion drainage , which could allow appropriate choice of definitive management ( pleurodesis vs indwelling catheter ) , reducing the number of interventions required to treat malignant pleural effusion .

###25511777
BACKGROUND	Oral care is important for oral and systemic health , especially for elderly institutionalized individuals and compromised patients .
BACKGROUND	However , conventional mechanical plaque control is often difficult for these patients because of the pain or the risk of aspiration .
BACKGROUND	Although antimicrobial photodynamic therapy ( aPDT ) , which is considered an alternative or adjunct to mechanical approaches , has potential application as a less stressful method of daily plaque control , no clinical application of this technique has been reported .
METHODS	We investigated the inhibitory effect of a combination of toluidine blue O ( TBO ) , and a red light-emitting diode ( LED ) on dental plaque formation in healthy volunteers .
METHODS	The optimal concentration of TBO was determined in preliminary in vitro experiments to evaluate the bactericidal effect of aPDT on Streptococcus oralis and to clarify its safety in fibroblast cells .
METHODS	To survey the mechanism of TBO-mediated aPDT , the quality and quantity of reactive oxygen species ( ROS ) generated during aPDT were also examined using electron spin resonance ( ESR ) spectroscopy .
METHODS	Subsequently , the inhibitory effect of aPDT on dental plaque formation was investigated in eleven subjects as a clinical pilot study .
METHODS	The right or left mandibular premolars were randomly assigned to the treatment ( with aPDT ) or control ( without aPDT ) groups .
METHODS	In total , aPDT was applied six times ( twice per day ) to the teeth in the test group over a period of four days .
METHODS	On the fourth day , the study concluded and the analyses were performed .
RESULTS	A combination of 500 or 1000 g/ml TBO and LED irradiation for 20 s significantly decreased the number of colony forming units of Streptococcus oralis .
RESULTS	The cytotoxicity of aPDT was comparable to that of standard antiseptics used in the oral cavity .
RESULTS	Hydroxyl radicals were detected by ESR analysis , but singlet oxygen was not .
RESULTS	A randomized controlled trial demonstrated that aPDT with 1000 g/ml TBO and red LED irradiation significantly suppressed dental plaque formation without harming teeth or the surrounding tissues .
CONCLUSIONS	aPDT has the potential to be a promising novel technical modality for dental plaque control .
BACKGROUND	This trial was registered with University Hospital Medical Information Network Clinical Trials Registry ( number UMIN000012504 ) .

###24368466
OBJECTIVE	Familial amyloid polyneuropathy , a lethal genetic disease caused by aggregation of variant transthyretin , induces progressive peripheral nerve deficits and disability .
OBJECTIVE	Diflunisal , a nonsteroidal anti-inflammatory agent , stabilizes transthyretin tetramers and prevents amyloid fibril formation in vitro .
OBJECTIVE	To determine the effect of diflunisal on polyneuropathy progression in patients with familial amyloid polyneuropathy .
METHODS	International randomized , double-blind , placebo-controlled study conducted among 130 patients with familial amyloid polyneuropathy exhibiting clinically detectable peripheral or autonomic neuropathy at amyloid centers in Sweden ( Ume ) , Italy ( Pavia ) , Japan ( Matsumoto and Kumamoto ) , England ( London ) , and the United States ( Boston , Massachusetts ; New York , New York ; and Rochester , Minnesota ) from 2006 through 2012 .
METHODS	Participants were randomly assigned to receive diflunisal , 250 mg ( n = 64 ) , or placebo ( n = 66 ) twice daily for 2 years .
METHODS	The primary end point , the difference in polyneuropathy progression between treatments , was measured by the Neuropathy Impairment Score plus 7 nerve tests ( NIS +7 ) which ranges from 0 ( no neurological deficits ) to 270 points ( no detectable peripheral nerve function ) .
METHODS	Secondary outcomes included a quality-of-life questionnaire ( 36-Item Short-Form Health Survey [ SF-36 ] ) and modified body mass index .
METHODS	Because of attrition , we used likelihood-based modeling and multiple imputation analysis of baseline to 2-year data .
RESULTS	By multiple imputation , the NIS +7 score increased by 25.0 ( 95 % CI , 18.4-31 .6 ) points in the placebo group and by 8.7 ( 95 % CI , 3.3-14 .1 ) points in the diflunisal group , a difference of 16.3 points ( 95 % CI , 8.1-24 .5 points ; P < .001 ) .
RESULTS	Mean SF-36 physical scores decreased by 4.9 ( 95 % CI , -7.6 to -2.2 ) points in the placebo group and increased by 1.5 ( 95 % CI , -0.8 to 3.7 ) points in the diflunisal group ( P < .001 ) .
RESULTS	Mean SF-36 mental scores declined by 1.1 ( 95 % CI , -4.3 to 2.0 ) points in the placebo group while increasing by 3.7 ( 95 % CI , 1.0-6 .4 ) points in the diflunisal group ( P = .02 ) .
RESULTS	By responder analysis , 29.7 % of the diflunisal group and 9.4 % of the placebo group exhibited neurological stability at 2 years ( < 2-point increase in NIS +7 score ; P = .007 ) .
CONCLUSIONS	Among patients with familial amyloid polyneuropathy , the use of diflunisal compared with placebo for 2 years reduced the rate of progression of neurological impairment and preserved quality of life .
CONCLUSIONS	Although longer-term follow-up studies are needed , these findings suggest benefit of this treatment for familial amyloid polyneuropathy .
BACKGROUND	clinicaltrials.gov Identifier : NCT00294671 .

###24797321
BACKGROUND	It has been known that ADH1B * 2 allele has a protective effect against the development of alcohol dependence .
BACKGROUND	However , the protection mechanism is still unknown .
BACKGROUND	We investigated whether ADH1B gene polymorphism affects ethanol ( EtOH ) metabolism .
METHODS	In a parent study , we conducted a randomized crossover trials on 24 healthy male subjects who were selected by genotyping : 12 with ALDH2 * 1 / * 1 ( active form ) and 12 with ALDH2 * 1 / * 2 ( inactive form ) .
METHODS	In the present study , the 24 subjects were reclassified into 2 groups of 11 with ADH1B * 1 / * 2 and 13 with ADH1B * 2 / * 2 according to the ADH1B genotypes .
METHODS	Each subject was administered 1 of 3 doses of EtOH ( 0.25 , 0.5 , 0.75 g/kg ) or a placebo in 4 trials .
METHODS	After the administration of alcohol , blood EtOH and acetaldehyde concentrations were measured 9 times over 4 hours .
RESULTS	In the case of EtOH , the area under the concentration-time curve from 0 to 4 hours ( AUC0-4 ) and the peak blood concentration of EtOH ( Cmax ) in subjects with ADH1B * 2 / * 2 were significantly higher than those in subjects with ADH1B * 1 / * 2 at all 3 dosages before stratifying by ALDH2 genotype .
RESULTS	However , after stratifying by ALDH2 genotype , a statistically significant difference between ADH1B * 2 / * 2 and ADH1B * 1 / * 2 was found only at the 0.5 g/kg dosage regardless of ALDH2 genotype .
RESULTS	In the case of acetaldehyde , the AUC0-4 and Cmax of acetaldehyde of ADH1B * 2 / * 2 after administration of 0.25 g/kg alcohol and the AUC0-4 of acetaldehyde of ADH1B * 2 / * 2 at 0.5 g/kg were significantly higher than corresponding values of ADH1B * 1 / * 2 only in the group of ALDH2 * 1 / * 2 .
CONCLUSIONS	Our findings indicate that the blood EtOH concentrations of ADH1B * 2 / * 2 group are higher than those of ADH1B * 1 / * 2 group regardless of ALDH2 genotype , and the blood acetaldehyde concentrations of ADH1B * 2 / * 2 are also higher than those of ADH1B * 1 / * 2 only in the ALDH2 * 1 / * 2 group .
CONCLUSIONS	To our knowledge , this is the first report to demonstrate the association of ADH1B * 2 allele with blood EtOH and acetaldehyde levels in humans , and these results suggest that higher blood EtOH and acetaldehyde concentrations in ADH1B * 2 / * 2 may constitute the mechanism of protection against alcoholism by ADH1B * 2 / * 2 .

###24886272
BACKGROUND	Chronic kidney disease is associated with increased arterial stiffness even in the early stages and this is thought to be a key mediator in the pathophysiology of the increased cardiovascular risk associated with this condition .
BACKGROUND	The use of low-dose spironolactone has previously been shown to improve arterial stiffness and reduce left ventricular mass safely in early-stage chronic kidney disease in the context of careful monitoring at a university hospital .
BACKGROUND	However , the majority of patients with chronic kidney disease are managed by their general practitioners in the community .
BACKGROUND	It is not known whether similar beneficial effects can be achieved safely using spironolactone in the primary care setting .
BACKGROUND	The aim of this study is to determine whether low-dose spironolactone can safely lower arterial stiffness in patients with stage 3 chronic kidney disease in the primary care setting .
METHODS	STOP-CKD is a multicentre , prospective , randomized , double-blind , placebo-controlled pilot trial of 240 adult patients with stage 3 chronic kidney disease recruited from up to 20 general practices in South Birmingham , England .
METHODS	Participants will be randomly allocated using a secured web-based computer randomization system to receive either spironolactone 25mg once daily or a matching inactive placebo for 40weeks , followed by a wash-out period of 6weeks .
METHODS	Investigators , outcome assessors , data analysts and participants will all be blinded to the treatment allocation .
METHODS	The primary endpoint is improved arterial stiffness , as measured by carotid-femoral pulse wave velocity between baseline and 40weeks .
METHODS	The secondary endpoints are incidence of hyperkalaemia , change in estimated glomerular filtration rate , change in urine albumin : creatinine ratio , change in brachial blood pressure , change in pulse waveform characteristics and overall tolerability of spironolactone .
METHODS	An additional quality control study , aiming to compare the laboratory serum potassium results of samples processed via two methods ( utilizing routine transport or centrifugation on site before rapid transport to the laboratory ) for 100 participants and a qualitative research study exploring patients ' and general practitioners ' attitudes to research and the use of spironolactone in chronic kidney disease in the community setting will be embedded in this pilot study .
BACKGROUND	Current Controlled Trials ISRCTN80658312 .

###26139208
OBJECTIVE	Herpes simplex virus type 2 ( HSV-2 ) biomarkers are often used in adolescent sub-Saharan HIV prevention studies , but evaluations of test performance and disclosure outcomes are rare in the published literature .
OBJECTIVE	Therefore , we investigated the proportion of ELISA-positive and indeterminate samples confirmed by western blot ( WB ) , the psychosocial response to disclosure and whether reports of sexual behaviour and HSV-2 symptoms are consistent with WB confirmatory results among adolescent orphans in Kenya .
METHODS	In 2011 , 837 Kenyan orphan youth in grades 7 and 8 enrolled in an HIV prevention clinical trial with HSV-2 biomarker outcomes .
METHODS	We used a modified algorithm for the Kalon HSV-2 ELISA to improve specificity ; positive and indeterminate results were WB tested .
METHODS	We developed culturally sensitive protocols for disclosing positive results , and documented psychosocial responses , reports of sexual contact and HSV-2 symptoms .
RESULTS	28 adolescents ( 3.3 % ) were identified as HSV-2 seropositive , six as indeterminate .
RESULTS	Of these , 22 positive and all indeterminates were WB tested ; 20 and 5 , respectively , were confirmed positive .
RESULTS	Most youth reported moderate brief stress after disclosure ; 22 % reported longer and more severe distress .
RESULTS	Boys were more likely to be in the latter category .
RESULTS	Self-reported virginity was highly inconsistent with WB-confirmed positives .
CONCLUSIONS	The higher than manufacturer 's cut-off for Kalon ELISA modestly reduced the rate of false-positive test results , but also increased false negatives .
CONCLUSIONS	Investigators should consider the risk : benefit ratio in deciding whether or not to disclose HSV-2 results to adolescent participants under specific field conditions .
BACKGROUND	NCT01501864 .

###25196721
BACKGROUND	We investigated and compared the effects of 2 different types of upper extremity exercise training on upper extremity function , strength , endurance , and ambulation in patients with early-stage Duchenne muscular dystrophy ( DMD ) .
METHODS	The study group ( n = 12 ) exercised with an arm ergometer under the supervision of a physiotherapist , whereas the control group ( n = 12 ) underwent a strengthening range-of-motion ( ROM ) exercise program under the supervision of their families at home for 8 weeks .
METHODS	Upper extremity functional performance , strength , endurance , and ambulatory status were assessed before and after the training .
RESULTS	Ambulation scores , endurance , and arm functions , as well as proximal muscle strength , were improved after the training in the study group ( P < 0.05 ) .
CONCLUSIONS	These results demonstrate that upper extremity training with an arm ergometer is more effective in preserving and improving the functional level of early-stage DMD patients compared to ROM exercises alone .

###25766689
OBJECTIVE	To evaluate whether follow-up of patients with obstructive sleep apnoea ( OSA ) undergoing CPAP treatment could be performed in primary care ( PC ) settings .
METHODS	Non-inferiority , randomised , prospective controlled study .
METHODS	Sleep unit ( SU ) at the University Hospital and in 8 PC units in Lleida , Spain .
METHODS	Patients with OSA were randomised to be followed up at the SU or PC units over a 6-month period .
METHODS	The primary outcome was CPAP compliance at 6months .
METHODS	The secondary outcomes were Epworth Sleep Scale ( ESS ) score , EuroQoL , patient satisfaction , body mass index ( BMI ) , blood pressure and cost-effectiveness .
RESULTS	We included 101 patients in PC ( ( meanSD ) apnoea-hypopnoea index ( AHI ) 50.822.9 / h , age 56.211 years , 74 % male ) and 109 in the SU ( AHI 51.424.4 / h , age 55.811 years , 77 % male ) ) .
RESULTS	The CPAP compliance was ( mean ( 95 % CI ) 4.94 ( 4.47 to 5.5 ) vs 5.23 ( 4.79 to 5.66 ) h , p = 0.18 ) in PC and SU groups , respectively .
RESULTS	In the SU group , there were greater improvements in ESS scores ( mean change 1.79 , 95 % CI +0.05 to +3.53 , p = 0.04 ) and patient satisfaction ( -1.49 , 95 % CI -2.22 to -0.76 ) ; there was a significant mean difference in BMI between the groups ( 0.57 , 95 % CI +0.01 to +1.13 , p = 0.04 ) .
RESULTS	In the PC setting , there was a cost saving of 60 % , with similar effectiveness , as well as a decrease in systolic blood pressure ( -5.32 ; 95 % CI -10.91 to +0.28 , p = 0.06 ) .
CONCLUSIONS	For patients with OSA , treatment provided in a PC setting did not result in worse CPAP compliance compared with a specialist model and was shown to be a cost-effective alternative .
BACKGROUND	Clinical Trials NCT01918449 .

###25601942
BACKGROUND	Japanese encephalitis ( JE ) is a vaccine-preventable acute disease .
BACKGROUND	We report the results of a phase 2/3 trial of JENVAC , a Vero cell-derived vaccine developed using an Indian strain of JE virus ( JEV ) .
METHODS	JENVAC was administered in 2 doses 28 days apart , and immunogenicity was compared to that from a single dose of SA-14-14-2 , the only approved JE vaccine and regimen at the time in India .
RESULTS	After both the doses , seroconversion and seroprotection were > 90 % for JENVAC .
RESULTS	For SA-14-14-2 , seroconversion and seroprotection were 57.69 % and 77.56 % , respectively , on day 28 and 39.74 % and 60.26 % , respectively , on day 56 .
RESULTS	The geometric mean titers at day 28 and day 56 were 145.04 and 460.53 , respectively , for JENVAC and 38.56 and 25.29 , respectively , for SA-14-14-2 .
RESULTS	With a single dose of JENVAC , seroprotection titers lasted at least 12 months in > 80 % of the subjects .
RESULTS	Following receipt of 2 doses , 61.17 % of subjects retained seroprotection titers at 24 months , and immunogenicity criteria were higher than that for SA-14-14-2 at 12 , 18 , and 24 months each .
RESULTS	Sera from JENVAC subjects neutralized JEV genotypes I , II , III , and IV equally well .
RESULTS	Adverse events were not significantly different between the 2 vaccines .
CONCLUSIONS	JENVAC elicits long-lasting , broadly protective immunity .
BACKGROUND	CTRI/2011/07 / 001855 .

###24392848
BACKGROUND	Experimental studies suggest that pretreatment with - agonists might prevent acute lung injury ( ALI ) .
OBJECTIVE	To determine if in adult patients undergoing elective esophagectomy , perioperative treatment with inhaled - agonists effects the development of early ALI .
METHODS	We conducted a randomized placebo-controlled trial in 12 UK centers ( 2008-2011 ) .
METHODS	Adult patients undergoing elective esophagectomy were allocated to prerandomized , sequentially numbered treatment packs containing inhaled salmeterol ( 100 g twice daily ) or a matching placebo .
METHODS	Patients , clinicians , and researchers were masked to treatment allocation .
METHODS	The primary outcome was development of ALI within 72 hours of surgery .
METHODS	Secondary outcomes were ALI within 28 days , organ failure , adverse events , survival , and health-related quality of life .
METHODS	An exploratory substudy measured biomarkers of alveolar-capillary inflammation and injury .
RESULTS	A total of 179 patients were randomized to salmeterol and 183 to placebo .
RESULTS	Baseline characteristics were similar .
RESULTS	Treatment with salmeterol did not prevent early lung injury ( 32 [ 19.2 % ] of 168 vs. 27 [ 16.0 % ] of 170 ; odds ratio [ OR ] , 1.25 ; 95 % confidence interval [ CI ] , 0.71-2 .22 ) .
RESULTS	There was no difference in organ failure , survival , or health-related quality of life .
RESULTS	Adverse events were less frequent in the salmeterol group ( 55 vs. 70 ; OR , 0.63 ; 95 % CI , 0.39-0 .99 ) , predominantly because of a lower number of pneumonia ( 7 vs. 17 ; OR , 0.39 ; 95 % CI , 0.16-0 .96 ) .
RESULTS	Salmeterol reduced some biomarkers of alveolar inflammation and epithelial injury .
CONCLUSIONS	Perioperative treatment with inhaled salmeterol was well tolerated but did not prevent ALI .
CONCLUSIONS	Clinical trial registered with International Standard Randomized Controlled Trial Register ( ISRCTN47481946 ) and European Union database of randomized Controlled Trials ( EudraCT 2007-004096-19 ) .

###25543612
OBJECTIVE	To evaluate the clinical outcome of sonic endo-instruments in combination with Mtwo Ni-Ti files in root canal preparation of molars .
METHODS	One hundred patients ( 118 first molars , 428 root canals ) were included in this study , they were randomly assigned into 2 groups ( n = 50 ) .
METHODS	Group 1 was shaped with sonic endo-instruments in combination with Mtwo Ni-Ti files , while group 2 was treated with stainless-steel files , both groups were obturated with lateral condensation technique .
METHODS	The time of root canal shaping , acute post-operative pain , the quality of the root canal filling and the success rate after 1 year were recorded and analyzed using SPSS 11.0 software package .
RESULTS	The average preparation time in group 1 was ( 5.30.6 ) min/canal and ( 12.70.9 ) min/canal in group 2 ( t = 100.89 , P < 0.001 ) .
RESULTS	The rate of acute postoperative pain was significantly lower X ( 2 ) = 4.87 , P < 0.05 , in group 1 ( 8.20 % ) than in group 2 ( 22.81 % ) ; in group 1 , 92.86 % root canals were filled adequately while only 78.92 % in group 2 , the difference was significant ( X ( 2 ) = 17.45 , P < 0.05 ) ; higher success rate ( X ( 2 ) = 3.95 , P < 0.05 ) after 1 year was achieved in group 1 ( 91.80 % ) compared with group 2 ( 78.95 % ) .
CONCLUSIONS	Compared with stainless-steel files , sonic endo instruments in combination with Mtwo Ni-Ti files in root canal preparation of molars seem more effective , cause less postoperative pain and offer higher success rates .

###25102198
OBJECTIVE	To determine which patients respond best to stereotactic radiotherapy ( SRT ) for neovascular age-related macular degeneration .
METHODS	Participants ( n = 230 ) receiving intravitreal anti-vascular endothelial growth factor injections for neovascular age-related macular degeneration enrolled in a randomized , double-masked sham-controlled trial comparing 16 Gray , 24 Gray , or Sham SRT .
METHODS	In a post hoc analysis , participants were grouped according to their baseline characteristics , to determine if these influenced SRT efficacy .
RESULTS	At 52 weeks , SRT was most effective for lesions 4 mm in greatest linear dimension and with a macular volume greater than the median value of 7.4 mm .
RESULTS	For 26 % of the participants with both these characteristics , SRT resulted in 55 % fewer ranibizumab injections ( 2.08 vs. 4.60 ; P = 0.0002 ) , a mean visual acuity change that was 5.33 letters superior to sham ( +2.18 vs. -3.15 letters ; P = 0.0284 ) , and a 71.1-m greater reduction in mean central subfield thickness ( -122.6 vs. -51.5 m ; P = 0.027 ) .
RESULTS	Other features associated with a positive response to SRT included pigment epithelial detachment and the absence of fibrosis .
CONCLUSIONS	Stereotactic radiotherapy is most effective for neovascular age-related macular degeneration lesions that are actively leaking at the time of treatment , and no larger than the 4-mm treatment zone .

###24295507
OBJECTIVE	To evaluate the efficacy of a stand-alone personalized normative feedback ( PNF ) intervention targeting misperceptions of gambling among college students .
METHODS	Undergraduates ( N = 136 ; 55 % male ) who reported gambling in the past 30 days were recruited between September 2011 and March 2012 .
METHODS	Using a randomized clinical trial design , participants were assigned to receive either PNF or an attention control task .
METHODS	In addition to self-report , this study used 2 computer-based risk tasks framed as `` gambling opportunities '' to assess cognitive and behavioral change at 1 week post intervention .
RESULTS	After 1 week , participants receiving PNF showed a marked decrease in perception of other students ' gambling , and evinced lower risk-taking performance on 2 analog measures of gambling .
CONCLUSIONS	Changes in both self-reported perceived norms and analog gambling behavior suggest that a single , stand-alone PNF intervention may modify gambling among college students .
CONCLUSIONS	Whether it can impact gambling outside of the laboratory remains untested .

###25038853
OBJECTIVE	To evaluate interobserver agreement and time-trend in chest CT assessment of emphysema , airways , and interstitial abnormalities in a lung cancer screening cohort .
METHODS	Visual assessment of baseline and fifth-year examination of 1990 participants was performed independently by two observers .
METHODS	Results were standardised by means of an electronic score sheet ; kappa and time-trend analyses were performed .
RESULTS	Interobserver agreement was substantial in early emphysema diagnosis ; highly significant ( p < 0.001 ) time-trends in both emphysema presence and grading were found ( higher prevalence and grade of emphysema in late CT examinations ) .
RESULTS	Significant progression in emphysema was seen in continuous smokers , but not in former smokers .
RESULTS	Agreement on centrilobular emphysema subtype was substantial ; agreement on paraseptal subtype , moderate .
RESULTS	Agreement on panlobular and mixed subtypes was only fair .
RESULTS	Agreement was fair regarding airway analysis .
RESULTS	Interstitial abnormalities were infrequent in the cohort , and agreement on these was fair to moderate .
RESULTS	A highly significant time-trend was found regarding interstitial abnormalities , which were more frequent in late examinations .
CONCLUSIONS	Visual scoring of chest CT is able to characterise the presence , pattern , and progression of early emphysema .
CONCLUSIONS	Continuous smokers progress ; former smokers do not .
CONCLUSIONS	Substantial interobserver consistency in determining early-stage emphysema in low-dose CT. .
CONCLUSIONS	Longitudinal analyses show clear time-trends for emphysema presence and grading .
CONCLUSIONS	For continuous smokers , progression of emphysema was seen in all lung zones .
CONCLUSIONS	For former smokers , progression of emphysema was undetectable by visual assessment .
CONCLUSIONS	Onset and progression of interstitial abnormalities are visually detectable .

###25282163
BACKGROUND	Aortic root management in type A acute aortic dissection is controversial .
BACKGROUND	This study compared outcomes of root replacement ( RR ) interventions versus more conservative root ( CR ) management .
METHODS	Of 1,995 type A acute aortic dissection patients enrolled in the International Registry of Acute Aortic Dissection , 699 ( 35 % ) underwent RR interventions and 1,296 ( 65 % ) underwent CR management .
METHODS	Independent predictors of hospital and 3-year survival were identified using multivariable logistic and Cox regression models .
RESULTS	Compared with CR patients , RR patients were younger ( 56.9 versus 62.3 years ; p = 0.023 ) and more likely to present with larger root diameter ( 4.7 cm versus 4.0 cm ; p < 0.001 ) , Marfan syndrome ( 8.7 % versus 2.5 % ; p < 0.001 ) , aortic insufficiency ( 64.0 % versus 50.3 % ; p < 0.001 ) , and hypotension , shock , or tamponade ( 33.0 % versus 26.5 % ; p = 0.003 ) .
RESULTS	Root replacement management did not increase hospital mortality ( propensity score-adjusted odds ratio , 1.14 ; p = 0.674 ) .
RESULTS	On Kaplan-Meier analysis , 3-year survival ( RR , 92.5 % 1.7 % versus CR , 91.6 % 1.3 % ; log-rank p = 0.623 ) and freedom from aortic root reintervention ( RR , 99.2 % 0.1 % versus CR ,99.3 % 0.1 % ; log-rank p = 0.770 ) were similar .
RESULTS	Only 2 patients ( 1 per group ) underwent follow-up root reintervention .
RESULTS	Propensity score-adjusted Cox regression excluded a relationship between root treatment and follow-up survival ( hazard ratio , 1.5 ; 95 % confidence interval , 0.502 to 5.010 ; p = 0.432 ) .
CONCLUSIONS	In type A acute aortic dissection patients more-extensive RR interventions are not associated withincreased hospital mortality .
CONCLUSIONS	This supports such anapproach in young patients and patients with connective tissue diseases and bicuspid aortic valves .
CONCLUSIONS	Excellent midterm survival and freedom from root reintervention in both groups suggest stable behavior of the nonreplaced aortic sinuses at 3 years .
CONCLUSIONS	Thus , pending studies with longer follow-up , the use of aggressive RR techniques can be determined by patient-specific and dissection-related factors .

###24412138
OBJECTIVE	To identify clinical conditions associated with a large increase ( spike ) in the heart rate characteristics index in very low birth weight ( VLBW ) infants .
METHODS	Retrospective medical record review within a day of all large heart rate characteristics index spikes ( increase of 3 from the previous 5-day average ) in VLBW infants at a single center enrolled from 2007 to 2010 in a multicenter trial of heart rate characteristics monitoring .
METHODS	In the trial , infants were randomized to having their heart rate characteristics index displayed to clinicians or not displayed .
RESULTS	Of 274 eligible infants , 224 large heart rate characteristics spikes occurred in 105 infants .
RESULTS	Thirty-three spikes were associated with surgery or procedures requiring anesthetic or anticholinergic medications , and infection-related conditions were the most common clinical association with the other spikes .
RESULTS	Of the first spikes in 47 infants randomized to conventional monitoring ( heart rate characteristics index not displayed to clinicians ) , 53 % were associated with suspected or proven infection .
RESULTS	Respiratory deterioration without suspected infection occurred with 34 % , and no association was identified in 13 % .
RESULTS	Infants randomized to having their heart rate characteristics index displayed were more likely to have antibiotics initiated around the time of a large heart rate characteristics index spike .
CONCLUSIONS	Sepsis , other infectious or systemic inflammatory conditions , respiratory deterioration , and surgical procedures are the most common clinical associations with a large increase in the heart rate characteristics index in VLBW infants .
CONCLUSIONS	This information may improve use of heart rate characteristics monitors in patients in the neonatal intensive care unit .

###24485709
BACKGROUND	Small studies suggest peanut oral immunotherapy ( OIT ) might be effective in the treatment of peanut allergy .
BACKGROUND	We aimed to establish the efficacy of OIT for the desensitisation of children with allergy to peanuts .
METHODS	We did a randomised controlled crossover trial to compare the efficacy of active OIT ( using characterised peanut flour ; protein doses of 2-800 mg/day ) with control ( peanut avoidance , the present standard of care ) at the NIHR/Wellcome Trust Cambridge Clinical Research Facility ( Cambridge , UK ) .
METHODS	Randomisation ( 1:1 ) was by use of an audited online system ; group allocation was not masked .
METHODS	Eligible participants were aged 7-16 years with an immediate hypersensitivity reaction after peanut ingestion , positive skin prick test to peanuts , and positive by double-blind placebo-controlled food challenge ( DBPCFC ) .
METHODS	We excluded participants if they had a major chronic illness , if the care provider or a present household member had suspected or diagnosed allergy to peanuts , or if there was an unwillingness or inability to comply with study procedures .
METHODS	Our primary outcome was desensitisation , defined as negative peanut challenge ( 1400 mg protein in DBPCFC ) at 6 months ( first phase ) .
METHODS	Control participants underwent OIT during the second phase , with subsequent DBPCFC .
METHODS	Immunological parameters and disease-specific quality-of-life scores were measured .
METHODS	Analysis was by intention to treat .
METHODS	Fisher 's exact test was used to compare the proportion of those with desensitisation to peanut after 6 months between the active and control group at the end of the first phase .
METHODS	This trial is registered with Current Controlled Trials , number ISRCTN62416244 .
RESULTS	The primary outcome , desensitisation , was recorded for 62 % ( 24 of 39 participants ; 95 % CI 45-78 ) in the active group and none of the control group after the first phase ( 0 of 46 ; 95 % CI 0-9 ; p < 0001 ) .
RESULTS	84 % ( 95 % CI 70-93 ) of the active group tolerated daily ingestion of 800 mg protein ( equivalent to roughly five peanuts ) .
RESULTS	Median increase in peanut threshold after OIT was 1345 mg ( range 45-1400 ; p < 0001 ) or 255 times ( range 182-280 ; p < 0001 ) .
RESULTS	After the second phase , 54 % ( 95 % CI 35-72 ) tolerated 1400 mg challenge ( equivalent to roughly ten peanuts ) and 91 % ( 79-98 ) tolerated daily ingestion of 800 mg protein .
RESULTS	Quality-of-life scores improved ( decreased ) after OIT ( median change -161 ; p < 0001 ) .
RESULTS	Side-effects were mild in most participants .
RESULTS	Gastrointestinal symptoms were , collectively , most common ( 31 participants with nausea , 31 with vomiting , and one with diarrhoea ) , then oral pruritus after 63 % of doses ( 76 participants ) and wheeze after 041 % of doses ( 21 participants ) .
RESULTS	Intramuscular adrenaline was used after 001 % of doses ( one participant ) .
CONCLUSIONS	OIT successfully induced desensitisation in most children within the study population with peanut allergy of any severity , with a clinically meaningful increase in peanut threshold .
CONCLUSIONS	Quality of life improved after intervention and there was a good safety profile .
CONCLUSIONS	Immunological changes corresponded with clinical desensitisation .
CONCLUSIONS	Further studies in wider populations are recommended ; peanut OIT should not be done in non-specialist settings , but it is effective and well tolerated in the studied age group .
BACKGROUND	MRC-NIHR partnership .

###24860157
BACKGROUND	Surgery in the beach chair position ( BCP ) may reduce cerebral blood flow and oxygenation , resulting in neurological injuries .
BACKGROUND	The authors tested the hypothesis that a ventilation strategy designed to achieve end-tidal carbon dioxide ( E ' ( CO ) ) values of 40-42 mm Hg would increase cerebral oxygenation ( Sct ( O ) ) during BCP shoulder surgery compared with a ventilation strategy designed to achieve E ' ( CO ) values of 30-32 mm Hg .
METHODS	Seventy patients undergoing shoulder surgery in the BCP with general anaesthesia were enrolled in this randomized controlled trial .
METHODS	Mechanical ventilation was adjusted to maintain an E ' ( CO ) of 30-32 mm Hg in the control group and an E ' ( CO ) of 40-42 mm Hg in the study group .
METHODS	Cerebral oxygenation was monitored continuously in the operating theatre using near-infrared spectroscopy .
METHODS	Baseline haemodynamics and Sct ( O ) were obtained before induction of anaesthesia , and these values were then measured and recorded continuously from induction of anaesthesia until tracheal extubation .
METHODS	The number of cerebral desaturation events ( CDEs ) ( defined as a 20 % reduction in Sct ( O ) from baseline values ) was recorded .
RESULTS	No significant differences between the groups were observed in haemodynamic variables or phenylephrine interventions during the surgical procedure .
RESULTS	Sct ( O ) values were significantly higher in the study 40-42 group throughout the intraoperative period ( P < 0.01 ) .
RESULTS	In addition , the incidence of CDEs was lower in the study 40-42 group ( 8.8 % ) compared with the control 30-32 group ( 55.6 % , P < 0.0001 ) .
CONCLUSIONS	Cerebral oxygenation is significantly improved during BCP surgery when ventilation is adjusted to maintain E ' ( CO ) at 40-42 mm Hg compared with 30-32 mm Hg .
BACKGROUND	ClinicalTrials.gov NCT01546636 .

###24723487
BACKGROUND	Prognosis of unresectable glioblastoma ( GB ) remains poor , despite temozolomide ( TMZ ) - based chemoradiation .
BACKGROUND	Activity of bevacizumab ( BEV ) and irinotecan ( IRI ) has been reported in recurrent disease .
BACKGROUND	We evaluated BEV and IRI as neo-adjuvant and adjuvant treatment combined with TMZ-based chemoradiation for unresectable GB .
METHODS	Patients with unresectable GB , age 18-70 , IK 50 were eligible .
METHODS	The experimental arm ( BEV/IRI ) consisted of neo-adjuvant intravenous BEV , 10 mg/kg , and IRI , 125 mg/m ( 2 ) , every 2 weeks for four cycles before radiotherapy ( RT ) ( 60 Gy ) , concomitant oral TMZ , 75 mg/m ( 2 ) / day , and BEV , 10 mg/kg every 2 weeks .
METHODS	Adjuvant BEV and IRI were given every 2 weeks for 6 months .
METHODS	The control arm consisted of concomitant oral TMZ , 75 mg/m ( 2 ) / day during RT , and 150-200 mg/m ( 2 ) for 5 days every 28 days for 6 months .
METHODS	The use of BEV was allowed at progression in the control arm .
RESULTS	Patients ( 120 ) were included from April 2009 to January 2011 .
RESULTS	The working hypothesis was that treatment would increase the progression-free survival at 6 month ( PFS-6 ) from 50 % to 66 % .
RESULTS	The primary objective was not achieved , and only 30 out of 60 patients were alive without progression at 6 months ( 50.0 % [ IC95 % ( 36.8 ; 63.1 ) ] in the BEV/IRI arm when 37 out of 60 patients were required according to the Fleming decision rules .
RESULTS	PFS-6 was 7.1 months in BEV/IRI versus 5.2 months in the control arm .
RESULTS	The median overall survival was not different between the two arms ( 11.1 months ) .
RESULTS	Main toxicities were three fatal intracranial bleedings , three bile duct or digestive perforations/infections ( 1 fatal ) , and six thrombotic episodes in the BEV/IRI arm , whereas there was one intracranial bleeding , two bile duct or digestive perforations/infections ( 1 fatal ) , and one thrombotic episode in the control arm .
CONCLUSIONS	Neo-adjuvant and adjuvant BEV/IRI , combined with TMZ-radiation , is not recommended for further evaluation in the first-line treatment of unresectable GB .
BACKGROUND	Clinical trial registered under EUDRACT number 2008-002775-28 ( NCT01022918 ) .

###24903113
BACKGROUND	Physical therapists are well established as providers of treatments for common , painful , and disabling conditions , such as knee osteoarthritis ( OA ) .
BACKGROUND	Thus , they are well placed to deliver treatments that integrate physical and psychosocial elements .
BACKGROUND	Attention is usually given to outcomes of such programs , but few studies have examined the processes and outcomes of training physical therapists to deliver such treatments .
OBJECTIVE	The aim of this study was to describe the processes in training physical therapists : ( 1 ) to deliver a standardized pain coping skills treatment and ( 2 ) to evaluate the effectiveness of that training .
METHODS	This study was an analysis of data relating to therapist performance in a randomized clinical trial .
METHODS	Eleven physical therapists were trained to deliver a 10-session pain coping skills training program for people with knee OA as part of a randomized controlled trial ( N = 222 ) .
METHODS	The initial training was provided in a workshop format and included extensive , ongoing supervision by a psychologist and rigorous use of well-defined performance criteria to assess competence .
METHODS	Adherence to the program , ratings of performance , and use of advanced skills were all measured against these criteria in a sample ( n = 74 , 10 % ) of the audio recordings of the intervention sessions .
RESULTS	Overall , the physical therapists achieved a very high standard of treatment delivery , with 96.6 % adherence to the program and mean performance ratings all in the satisfactory range .
RESULTS	These results were maintained throughout the intervention and across all sessions .
CONCLUSIONS	Only 10 % of the delivered sessions were analyzed , and the physical therapists who took part in the study were a self-selected group .
CONCLUSIONS	This study demonstrated that a systematic approach to training and accrediting physical therapists to deliver a standardized pain coping skills program can result in high and sustained levels of adherence to the program .
CONCLUSIONS	Training fidelity was achieved in this group of motivated clinicians , but the supervision provided was time intensive .
CONCLUSIONS	The data provide a promising indicator of greater potential for psychologically informed practice to be a feature of effective health care .

###24351527
BACKGROUND	Venous thromboembolism ( VTE ) prophylaxis remains debated following trauma , and recommendations have not been established .
BACKGROUND	Although hyperfibrinogenemia is a marker of proinflammatory states , it also contributes to thrombus formation .
BACKGROUND	Postinjury hyperfibrinogenemia is common , but the effect of hyperfibrinogenemia on VTE prophylaxis has not been fully elucidated .
BACKGROUND	Therefore , we hypothesized that heparin is less effective for VTE prophylaxis following severe injury due to hyperfibrinogenemia .
METHODS	In vitro studies evaluated thromboelastography ( TEG ) parameters in 10 healthy volunteers after the addition of fibrinogen concentrate and heparin .
METHODS	Data from a recent randomized controlled trial , conducted at an academic level I trauma center surgical intensive care unit , were reviewed .
METHODS	Critically injured patients were randomized to standard VTE prophylaxis ( 5,000 U low-molecular-weight heparin daily ) or TEG-guided prophylaxis ( up to 10,000 U low-molecular-weight heparin daily ) and were followed up for 5 days .
METHODS	Analysis was performed to evaluate the relationship between fibrinogen levels , measures of anticoagulation , and TEG parameters .
RESULTS	In vitro studies revealed increased fibrinogen reversed the effects of heparin as measured by TEG .
RESULTS	Fifty patients were enrolled in the clinical study with 25 in each arm .
RESULTS	Thromboelastography parameters , fibrinogen , platelet count , and anti-Xa levels did not differ between groups despite treatment provided .
RESULTS	Fibrinogen levels increased over the 5-day study period ( 597 24.0 to 689.3 25.0 ) , as well as clot strength ( 9.8 0.4 to 14.5 0.6 ) , which had a significant correlation coefficient ( P < 0.01 ) .
RESULTS	Moreover , there was a moderate inverse correlation between fibrinogen level and the effect of heparin ( RF ) , which was significant on study days 1 and 3 , implicating hyperfibrinogenemia in heparin resistance .
CONCLUSIONS	Hypercoagulability and heparin resistance are common following trauma .
CONCLUSIONS	The preclinical and clinical relationships between fibrinogen levels and hypercoagulability implicate hyperfibrinogenemia as a potential factor in heparin resistance .

###25958769
OBJECTIVE	( Primary ) To establish the effect of antenatal group self-hypnosis for nulliparous women on intra-partum epidural use .
METHODS	Multi-method randomised control trial ( RCT ) .
METHODS	Three NHS Trusts .
METHODS	Nulliparous women not planning elective caesarean , without medication for hypertension and without psychological illness .
METHODS	Randomisation at 28-32 weeks ' gestation to usual care , or to usual care plus brief self-hypnosis training ( two 90-minute groups at around 32 and 35 weeks ' gestation ; daily audio self-hypnosis CD ) .
METHODS	Follow up at 2 and 6 weeks postnatal .
METHODS	Primary : epidural analgesia .
METHODS	Secondary : associated clinical and psychological outcomes ; cost analysis .
RESULTS	Six hundred and eighty women were randomised .
RESULTS	There was no statistically significant difference in epidural use : 27.9 % ( intervention ) , 30.3 % ( control ) , odds ratio ( OR ) 0.89 [ 95 % confidence interval ( CI ) : 0.64-1 .24 ] , or in 27 of 29 pre-specified secondary clinical and psychological outcomes .
RESULTS	Women in the intervention group had lower actual than anticipated levels of fear and anxiety between baseline and 2 weeks post natal ( anxiety : mean difference -0.72 , 95 % CI -1.16 to -0.28 , P = 0.001 ) ; fear ( mean difference -0.62 , 95 % CI -1.08 to -0.16 , P = 0.009 ) [ Correction added on 7 July 2015 , after first online publication : ` Mean difference ' replaced ` Odds ratio ( OR ) ' in the preceding sentence . ]
RESULTS	Postnatal response rates were 67 % overall at 2 weeks .
RESULTS	The additional cost in the intervention arm per woman was 4.83 ( CI -257.93 to 267.59 ) .
CONCLUSIONS	Allocation to two-third-trimester group self-hypnosis training sessions did not significantly reduce intra-partum epidural analgesia use or a range of other clinical and psychological variables .
CONCLUSIONS	The impact of women 's anxiety and fear about childbirth needs further investigation .

###24582846
OBJECTIVE	The aim of this prospective randomized trial was to test the null hypothesis that there was no difference in the percentage of the fracture line of scaphoid waist fractures that demonstrated bridging bone on computed tomography ( CT ) 10 weeks after injury between patients treated in a below-elbow cast including or excluding the thumb .
METHODS	A total of 62 patients with a CT or magnetic resonance image-confirmed nondisplaced or minimally displaced fracture of the scaphoid were enrolled in a prospective , multicenter , randomized trial comparing treatment in a below-elbow cast including or excluding the thumb .
METHODS	There were 55 waist and 7 distal fractures ( owing to a miscommunication at 3 of the centers ) .
METHODS	We adhered to intention-to-treat principles .
METHODS	The primary outcome was the extent of union on CT performed after 10 weeks of cast treatment , expressed as a percentage of the fracture line that had bridging bone , determined by musculoskeletal radiologists blinded to treatment .
METHODS	Secondary study outcomes included wrist motion ; grip strength ; the Mayo Modified Wrist Score ; the Disabilities of the Arm , Shoulder and Hand score ; a visual analog scale for pain ; and radiographic union at 6 months after injury .
RESULTS	There was a significant difference in the average extent of union on CT at 10 weeks ( 85 % vs 70 % ) favoring treatment with a cast excluding the thumb .
RESULTS	The overall union rate was 98 % .
RESULTS	The 1 exception was a patient in the thumb immobilization group who elected operative treatment 1 week after enrollment , used crutches , and failed to heal .
RESULTS	There were no significant differences between groups for wrist motion ; grip strength ; Mayo Modified Wrist Score ; Disabilities of the Arm , Shoulder , and Hand score ; or pain intensity .
CONCLUSIONS	Immobilization of the thumb appears unnecessary for CT or magnetic resonance image-confirmed nondisplaced or minimally displaced fractures of the waist of the scaphoid .
METHODS	Therapeutic I.

###25417120
BACKGROUND	This study will evaluate hypoxia , as a novel concept in the pathogenesis of diabetic macular oedema ( DMO ) .
BACKGROUND	As the oxygen demand of the eye is maximum during dark-adaptation , we hypothesize that wearing light-masks during sleep will cause regression and prevent the development and progression of DMO .
BACKGROUND	The study protocol comprises both an efficacy and mechanistic evaluation to test this hypothesis .
METHODS	This is a phase III randomised controlled single-masked multicentre clinical trial to test the clinical efficacy of light-masks at preventing dark-adaptation in the treatment of non-central DMO .
METHODS	Three hundred patients with non-centre-involving DMO in at least one eye will be randomised 1:1 to light-masks and control masks ( with no light ) to be used during sleep at night for a period of 24 months .
METHODS	The primary outcome is regression of non-central oedema by assessing change in the zone of maximal retinal thickness at baseline on optical coherence tomography ( SD-OCT ) .
METHODS	Secondary outcomes will evaluate the prevention of development and progression of DMO by assessing changes in retinal thickness in different regions of the macula , macular volume , refracted visual acuity and level of retinopathy .
METHODS	Safety parameters will include sleep disturbance .
METHODS	Adverse events and measures of compliance will be assessed over 24 months .
METHODS	Participants recruited to the mechanistic sub-study will have additional retinal oximetry , multifocal electroretinography ( ERG ) and microperimetry to evaluate the role of hypoxia by assessing and comparing changes induced by supplemental oxygen and the light-masks at 12 months .
CONCLUSIONS	The outcomes of this study will provide insight into the pathogenesis of DMO and provide evidence on whether a simple , non-invasive device in the form of a light-mask can help prevent the progression to centre-involving DMO and visual impairment in people with diabetes .

###24907871
BACKGROUND	Pain is the primary complaint and the main reason for prolonged recovery after laparoscopic cholecystectomy .
BACKGROUND	The authors hypothesized that patients undergoing laparoscopic cholecystectomy will have less pain four hours after surgery when receiving maintenance of anesthesia with propofol when compared to isoflurane , desflurane , or sevoflurane .
METHODS	In this prospective , randomized trial , 80 patients scheduled for laparoscopic cholecystectomy were assigned to propofol , isoflurane , desflurane , or sevoflurane for the maintenance of anesthesia .
METHODS	Our primary outcome was pain measured on the numeric analog scale four hours after surgery .
METHODS	We also recorded intraoperative use of opioids as well as analgesic consumption during the first 24h after surgery .
RESULTS	There was no statistically significant difference in pain scores four hours after surgery ( p = 0.72 ) .
RESULTS	There were also no statistically significant differences in pain scores between treatment groups during the 24h after surgery ( p = 0.45 ) .
RESULTS	Intraoperative use of fentanyl and morphine did not vary significantly among the groups ( p = 0.21 and 0.24 , respectively ) .
RESULTS	There were no differences in total morphine and hydrocodone/APAP use during the first 24h ( p = 0.61 and 0.53 , respectively ) .
CONCLUSIONS	Patients receiving maintenance of general anesthesia with propofol do not have less pain after laparoscopic cholecystectomy when compared to isoflurane , desflurane , or sevoflurane .

###25555154
BACKGROUND	The aim of this study was twofold : First , to assess the personality profile of treatment-seeking adult outpatients with pathological gambling compared to a matched control group under the Alternative Five Factor Model perspective , and second , to determine which personality variables would predict treatment outcome .
METHODS	The final total sample consisted of 44 consecutive treatment-seeking pathological gamblers ( PGs ) and 88 controls paired by age and sex who completed the Zuckerman-Kuhlman Personality Questionnaire ( ZKPQ ) .
METHODS	Twelve months after starting an open program of individual cognitive-behavioral therapy , PGs were categorized as abstinent or treatment failure .
RESULTS	PGs scored significantly higher on Neuroticism-Anxiety .
RESULTS	Those who had relapsed or dropped out showed higher Impulsivity and Sensation Seeking scores .
RESULTS	Impulsivity emerged as a significant predictor of treatment failure .
RESULTS	Treatment-seeking PGs scored higher on Neuroticism-Anxiety and Impulsivity appeared as a risk factor of relapsing or dropping out .
CONCLUSIONS	Our findings support the importance of individual differences in personality on therapy outcomes .
CONCLUSIONS	The ZKPQ may constitute a useful tool to identify these individual differences that might be considered when making personalized treatment decisions to improve the effectiveness and quality of treatment interventions .

###24716336
OBJECTIVE	The purpose of this study was to determine whether a difference exists in learner performance and the type and frequency of diagnostic reasoning skills used , based on the method of case presentation .
BACKGROUND	Faculty can select from a variety of methods for presenting cases when teaching diagnostic reasoning , but little evidence exists with regard to how students use these skills while interacting with the cases .
METHODS	A total of 54 nursing students participated in two case analyses using human patient and computer-based simulations .
METHODS	Participant performance and diagnostic reasoning skills were analyzed .
RESULTS	Performance was significantly better with the human patient simulation case .
RESULTS	All diagnostic reasoning skills were used during both methods of case presentation , with greater performance variation in the computer-based simulation .
CONCLUSIONS	Both human patient and computer-based simulations are beneficial for practicing diagnostic reasoning skills ; however , these findings support the use of human patient simulations for improving student performance in case synthesis .

###24333515
OBJECTIVE	Given the limitations of prostate specific antigen and standard biopsies for detecting prostate cancer , we evaluated the cancer detection rate and external validity of a magnetic resonance imaging/transrectal ultrasound fusion guided prostate biopsy system used at the National Institutes of Health .
METHODS	We performed a phase III trial of a magnetic resonance imaging/transrectal ultrasound fusion guided prostate biopsy system with participants enrolled between 2012 and 2013 .
METHODS	A total of 153 men consented to the study and underwent 3 Tesla multiparametric magnetic resonance imaging with an endorectal coil for clinical suspicion of prostate cancer .
METHODS	Lesions were classified as low or moderate/high risk for prostate cancer .
METHODS	Magnetic resonance imaging/transrectal ultrasound fusion guided biopsy and standard 12-core prostate biopsy were performed and 105 men were eligible for analysis .
RESULTS	Mean patient age was 65.8 years and mean prostate specific antigen was 9.5 ng/ml .
RESULTS	The overall cancer detection rate was 62.9 % ( 66 of 105 patients ) .
RESULTS	The cancer detection rate in those with moderate/high risk on imaging was 72.3 % ( 47 of 65 ) vs 47.5 % ( 19 of 40 ) in those classified as low risk for prostate cancer ( p < 0.05 ) .
RESULTS	Mean tumor core length was 4.6 and 3.7 mm for fusion biopsy and standard 12-core biopsy , respectively ( p < 0.05 ) .
RESULTS	Magnetic resonance imaging/transrectal ultrasound fusion guided biopsy detected prostate cancer that was missed by standard 12-core biopsy in 14.3 % of cases ( 15 of 105 ) , of which 86.7 % ( 13 of 15 ) were clinically significant .
RESULTS	This biopsy upgraded 23.5 % of cancers ( 4 of 17 ) deemed clinically insignificant on 12-core biopsy to clinically significant prostate cancer necessitating treatment .
CONCLUSIONS	Magnetic resonance imaging/transrectal ultrasound fusion guided biopsy can improve prostate cancer detection .
CONCLUSIONS	The results of this trial support the external validity of this platform and may be the next step in the evolution of prostate cancer management .

###24467549
OBJECTIVE	Febuxostat , a novel non-purine selective inhibitor of xanthine oxidase , has been identified as a potential alternative to allopurinol in patients with hyperuricemia .
OBJECTIVE	The purpose of this study was to compare the urate-lowering ( UL ) efficacy and safety of daily febuxostat and allopurinol in Chinese gout patients with hyperuricemia .
METHODS	Gout patients ( n = 512 ) with serum uric acid ( sUA ) concentrations of at least 8.0 mg/dL were randomized to receive daily febuxostat 40mg or 80mg or allopurinol 300mg for 28weeks .
METHODS	Prophylaxis against gout flares with meloxicam or colchicine was provided during weeks 1 through 8 .
METHODS	The primary endpoint was the percentage of subjects achieving a sUA concentration of < 6.0 mg/dL at the last three monthly measurements .
RESULTS	The primary endpoint was reached in 44.77 % of patients receiving 80mg of febuxostat , 27.33 % of those receiving 40mg of febuxostat , and 23.84 % of those receiving allopurinol .
RESULTS	The UL efficacy in the febuxostat 80mg group was higher than in the allopurinol ( P < 0.0001 ) and febuxostat 40mg ( P = 0.0008 ) groups .
RESULTS	The UL efficacy of the febuxostat 40mg group was statistically non-inferior to that of the allopurinol group .
RESULTS	No significant change in the number of tophi was observed during the final visit relative to baseline in each treatment group .
RESULTS	The rate of gout flares requiring treatment from weeks 9 through 28 and the incidence of adverse events was similar among treatment groups .
CONCLUSIONS	The UL efficacy of daily febuxostat 80mg was greater than that of febuxostat 40mg and allopurinol 300mg , which exhibited comparable UL efficacy .
CONCLUSIONS	Safety of febuxostat and allopurinol was comparable at the doses tested .

###24858376
BACKGROUND	Effective functioning of the neurotransmitter serotonin is important for optimal cognitive and emotional function .
BACKGROUND	Dietary supplements able to increase availability to the brain of the precursor amino acid , tryptophan ( TRP ) , and thereby enhance serotonin synthesis , can have measurable impact on these psychological processes .
OBJECTIVE	This study involves a randomised controlled trial of a TRP-rich egg-white protein hydrolysate ( DSM Nutritional Products Ltd. , Switzerland ) on plasma amino acids , cognition , mood and emotional processing in older women .
METHODS	Following a baseline test day without treatment , 60 healthy women aged 45-65 years received drinks containing either 2 or 4 g of TRP-rich protein hydrolysate product or 3.11 g casein hydrolysate as a control .
METHODS	One hour later , they undertook a 2-h battery of cognitive and emotional tests .
RESULTS	The TRP-rich protein hydrolysate produced the expected dose-dependent increase in the ratio of plasma TRP to competing large neutral amino acids .
RESULTS	TRP-rich protein hydrolysate ( 2 g only ) prevented both the decline in wellbeing and increase in fatigue seen over the test session in the control group .
RESULTS	This treatment dose resulted in a significant shift in emotional processing towards positive words and reduced negative bias in assessing negative facial expressions .
RESULTS	Effects on cognition were small and not statistically reliable and are not reported here .
RESULTS	However , there was no evidence for any adverse effects .
CONCLUSIONS	Consumption of a low dose of TRP-rich protein hydrolysate may have beneficial effects on emotional function that could promote feelings of wellbeing , possibly conferring resistance to deterioration in mood in healthy subjects or depressive episodes .

###25163441
OBJECTIVE	There is concern that combining energy drinks with alcohol may ` mask ' subjective intoxication leading to greater alcohol consumption .
OBJECTIVE	This study examines the effects of alcohol alone and combined with energy drink on objective and subjective intoxication and mood over the course of 3h .
METHODS	Using a double-blind , placebo-controlled , balanced , crossover design , 24 participants ( mean age 22.23 years ) were administered with double placebo , 0.6 g/kg alcohol ( mean peak blood alcohol content of 0.051 % ) , 250ml energy drink and alcohol/energy drink , according to a Latin square design , with a washout of > 48h .
METHODS	On each visit , they were breathalysed and rated themselves on a comprehensive battery of mood items at baseline and then at 45 , 90 and 180min post-drink .
RESULTS	Blood alcohol and subjective intoxication were significantly increased following both alcohol alone and alcohol/energy drink .
RESULTS	Both measures were statistically indistinguishable between alcohol conditions .
RESULTS	In keeping with its ( 80mg ) caffeine content , the energy drink alone significantly increased self-rated ` alertness ' and reduced ` depression-dejection ' scores compared with the combined alcohol/energy drink .
RESULTS	The alcohol/energy drink increased ` vigor ' and ` contentment ' at 45min and decreased ` contentment ' at 180min .
CONCLUSIONS	The co-ingestion of an energy drink with alcohol does not differently influence blood alcohol content recordings or subjective intoxication compared with alcohol alone , although some mood items are differentially affected .

###24325147
BACKGROUND	Simethicone and N-acetylcysteine have been widely used in improving endoscopic visibility .
BACKGROUND	However , the optimal dose , volume , and dosing time for the premedication regimen are still unclear .
OBJECTIVE	Our aim was to assess the efficacy of premedication in improving endoscopic visibility and determine the contributions of dose , volume , and premedication time .
METHODS	A total of 1849 patients were prospectively treated in three groups : group A : 100-mg simethicone suspension in 5 mL water ; group B : 100-mg simethicone suspension in 100 mL water ; and group C : 100-mg simethicone suspension in 100 mL water containing 200 mg N-acetylcysteine .
METHODS	Mucosa visibility was assessed at seven sites of upper gastrointestinal tract .
METHODS	The sum of scores was considered as total mucosal visibility score ( TMVS ) .
RESULTS	The upper body of stomach had the worst visibility score for all groups .
RESULTS	TMVS of groups B and C were significantly lower than those of group A. Group C had a significantly fewer patients requiring endoscopic flushing than groups A and B.
RESULTS	The TMVS for groups B and C were significantly lower than for group A within 30 min of beginning premedication .
RESULTS	Beyond 30 min of premedication , there was no significant difference in the TMVS among groups .
CONCLUSIONS	Premedication using 100 mg simethicone in 100 mL of water improves endoscopic visibility .
CONCLUSIONS	Addition of N-acetylcysteine to simethicone in 100 mL of water reduces the need for endoscopic flushing .
CONCLUSIONS	For patients unable to tolerate a large fluid volume , a 5-mL simethicone suspension administered more than 30 min prior to upper endoscopy is suggested .

###25571679
OBJECTIVE	The aim of this study was to evaluate the remineralization effect of Casein Phosphopeptid Amorphous Calcium Phosphate ( CPP-ACP ) on white spot lesions ( WSL ) and its inhibitory effect on Streptococcus mutans colonization .
METHODS	The study group consisted of 60 children exhibiting at least 1-WSL .
METHODS	Subjects were randomly divided into 2 groups : a test group of using CPP-ACP cream ( Tooth Mousse , GC Europe N.V. , Leuven , Belgium ) and a control group using only fluoride containing toothpaste for a period of 3-months .
METHODS	Baseline WSLs were scored using DIAGNOdent device ( KaVo Germany ) and the saliva samples were collected to measure S. mutans counts .
METHODS	After the 3-month period the WSLs were again recorded and the saliva sample collection was repeated .
METHODS	Wilcoxon Signed Ranks Test was used for statistical analysis .
RESULTS	DIAGNOdent measurements were increased by time ( p = 0.002 ) in control group and no statistically significant diference ( p = 0.217 ) was found in test group by the 3-month period .
RESULTS	In both groups , the mutans counts were decreased in 3-month experimental period .
CONCLUSIONS	These clinical and laboratory results suggested that CPP-ACP containing cream had a slight remineralization effect on the WSL in the 3-month evaluation period however longer observation is recommended to confirm whether the greater change in WSLs is maintained .

###25697852
BACKGROUND	The endomyocardial biopsy ( EMB ) is considered the gold standard in rejection surveillance post cardiac transplant , but is invasive , with risk of complications .
BACKGROUND	A previous trial suggested that the gene expression profiling ( GEP ) blood test was noninferior to EMB between 6 and 60 months post transplant .
BACKGROUND	As most rejections occur in the first 6 months , we conducted a single-center randomized trial of GEP versus EMB starting at 55 days post transplant ( when GEP is valid ) .
RESULTS	Sixty heart transplant patients meeting inclusion criteria were randomized beginning at 55 days post transplant to either GEP or EMB arms .
RESULTS	A positive GEP 30 between 2 and 6 months , or 34 after 6 months , prompted a follow-up biopsy .
RESULTS	The primary end point included a composite of death/retransplant , rejection with hemodynamic compromise or graft dysfunction at 18 months post transplant .
RESULTS	A coprimary end point included change in first-year maximal intimal thickness by intravascular ultrasound , a recognized surrogate for long-term outcome .
RESULTS	Corticosteroid weaning was assessed in both the groups .
RESULTS	The composite end point was similar between the GEP and EMB groups ( 10 % versus 17 % ; log-rank P = 0.44 ) .
RESULTS	The coprimary end point of first-year intravascular ultrasound change demonstrated no difference in mean maximal intimal thickness ( 0.350.36 versus 0.360.26 mm ; P = 0.944 ) .
RESULTS	Steroid weaning was successful in both the groups ( 91 % versus 95 % ) .
CONCLUSIONS	In this pilot study , GEP starting at 55 days post transplant seems comparable with EMB for rejection surveillance in selected heart transplant patients and does not result in increased adverse outcomes .
CONCLUSIONS	GEP also seems useful to guide corticosteroid weaning .
CONCLUSIONS	Larger randomized trials are required to confirm these findings .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT014182482377 .

###24977342
BACKGROUND	Short-term advantages to laparoscopic surgery are well described .
BACKGROUND	This study compared medium - to long-term outcomes of a randomized clinical trial comparing laparoscopic and open colonic resection for cancer .
METHODS	The case notes of patients included in the LAFA study ( perioperative strategy in colonic surgery ; LAparoscopy and/or FAst track multimodal management versus standard care ) were reviewed 2-5years after randomization for incisional hernia , adhesional small bowel obstruction ( SBO ) , overall survival , cancer recurrence and quality of life ( QoL ) .
METHODS	The laparoscopic and open groups were compared irrespective of fast-track or standard perioperative care .
RESULTS	Data on incisional hernias , SBO , survival and recurrence were available for 399 of 400 patients : 208 laparoscopic and 191 open resections .
RESULTS	These outcomes were corrected for duration of follow-up .
RESULTS	Median follow-up was 34 ( i.q.r. 26-44 ) years .
RESULTS	Multivariable regression analysis showed that open resection was a risk factor for incisional hernia ( odds ratio ( OR ) 244 , 95 per cent confidence interval ( c.i. ) 112 to 526 ; P = 0022 ) and SBO ( OR 370 , 107 to 1250 ; P = 0039 ) .
RESULTS	There were no differences in overall survival ( hazard ratio 110 , 95 per cent c.i. 067 to 180 ; P = 0730 ) or in cumulative incidence of recurrence ( P = 0514 ) between the laparoscopic and open groups .
RESULTS	There were no measured differences in QoL in 281 respondents ( P > 0350 for all scales ) .
CONCLUSIONS	Laparoscopic colonic surgery led to fewer incisional hernia and adhesional SBO events .
BACKGROUND	NTR222 ( http://www.trialregister.nl ) .

###24357510
OBJECTIVE	Past studies that demonstrated that sexual dysfunction is common among women receiving chronic hemodialysis did not distinguish sexual dysfunction/difficulty from sexual inactivity .
OBJECTIVE	This study sought to differentiate these in order to elucidate the prevalence of true `` sexual dysfunction '' in this population .
METHODS	As part of a clinical trial of symptom management strategies in patients receiving chronic hemodialysis , female sexual function was prospectively assessed monthly for 6 months and quarterly thereafter using the Female Sexual Function Index , to which questions were added differentiating sexual dysfunction/difficulty from sexual inactivity .
METHODS	Beginning in month 7 , patients were asked three questions about sexual activity , difficulty , and satisfaction monthly .
RESULTS	Of the women enrolled in the clinical trial ,125 participants completed 1721 assessments between 2009 and 2011 .
RESULTS	Scores on 574 of 643 ( 89 % ) quarterly Female Sexual Function Index assessments were consistent with sexual dysfunction , due largely to sexual inactivity , which was reported on 525 ( 82 % ) quarterly assessments .
RESULTS	When reported ( n = 1663 ) , the most frequently described reasons for sexual inactivity were lack of interest in sex ( n = 715 ; 43 % ) and lack of a partner ( n = 647 ; 39 % ) , but rarely sexual difficulty ( n = 36 ; 2 % ) .
RESULTS	When reported ( n = 1582 ) , women were moderately to very satisfied with their sexual life on 1020 ( 64 % ) assessments and on 513 of 671 ( 76 % ) assessments in which lack of interest was cited as a reason for sexual inactivity .
RESULTS	Women indicated an interest in learning about the causes of and treatment for sexual dysfunction on just 5 % of all assessments .
CONCLUSIONS	Although many women receiving chronic hemodialysis are sexually inactive , few describe sexual difficulty .
CONCLUSIONS	Most , including those with a lack of interest in sex , are satisfied with their sexual life and few wish to learn about treatment options .
CONCLUSIONS	These findings suggest that true sexual dysfunction is uncommon in this population and that treatment opportunities are rare .

###25209620
OBJECTIVE	To investigate the long term effectiveness of integrated disease management delivered in primary care on quality of life in patients with chronic obstructive pulmonary disease ( COPD ) compared with usual care .
METHODS	24 month , multicentre , pragmatic cluster randomised controlled trial
METHODS	40 general practices in the western part of the Netherlands
METHODS	Patients with COPD according to GOLD ( Global Initiative for COPD ) criteria .
METHODS	Exclusion criteria were terminal illness , cognitive impairment , alcohol or drug misuse , and inability to fill in Dutch questionnaires .
METHODS	Practices were included if they were willing to create a multidisciplinary COPD team .
METHODS	General practitioners , practice nurses , and specialised physiotherapists in the intervention group received a two day training course on incorporating integrated disease management in practice , including early recognition of exacerbations and self management , smoking cessation , physiotherapeutic reactivation , optimal diagnosis , and drug adherence .
METHODS	Additionally , the course served as a network platform and collaborating healthcare providers designed an individual practice plan to integrate integrated disease management into daily practice .
METHODS	The control group continued usual care ( based on international guidelines ) .
METHODS	The primary outcome was difference in health status at 12 months , measured by the Clinical COPD Questionnaire ( CCQ ) ; quality of life , Medical Research Council dyspnoea , exacerbation related outcomes , self management , physical activity , and level of integrated care ( PACIC ) were also assessed as secondary outcomes .
RESULTS	Of a total of 1086 patients from 40 clusters , 20 practices ( 554 patients ) were randomly assigned to the intervention group and 20 clusters ( 532 patients ) to the usual care group .
RESULTS	No difference was seen between groups in the CCQ at 12 months ( mean difference -0.01 , 95 % confidence interval -0.10 to 0.08 ; P = 0.8 ) .
RESULTS	After 12 months , no differences were seen in secondary outcomes between groups , except for the PACIC domain `` follow-up/coordination '' ( indicating improved integration of care ) and proportion of physically active patients .
RESULTS	Exacerbation rates as well as number of days in hospital did not differ between groups .
RESULTS	After 24 months , no differences were seen in outcomes , except for the PACIC follow-up/coordination domain .
CONCLUSIONS	In this pragmatic study , an integrated disease management approach delivered in primary care showed no additional benefit compared with usual care , except improved level of integrated care and a self reported higher degree of daily activities .
CONCLUSIONS	The contradictory findings to earlier positive studies could be explained by differences between interventions ( provider versus patient targeted ) , selective reporting of positive trials , or little room for improvement in the already well developed Dutch healthcare system .
BACKGROUND	Netherlands Trial Register NTR2268 .

###24330422
BACKGROUND	Malaria is a leading cause of morbidity and mortality among young children and is estimated to cause at least 1 million deaths each year especially among pregnant women and young children under the age of five years .
BACKGROUND	Vitamin A supplementation is known to reduce morbidity and mortality in young children .
BACKGROUND	Zinc is required for growth and immunity and we sought to replicate the study by Zeba et al. which showed 30 % lower cases of clinical malaria in children on a combination of zinc and a large dose of vitamin A compared with children on vitamin A alone based on the hypothesis that combined vitamin A and zinc reduced symptomatic malaria compared to vitamin A alone .
OBJECTIVE	The primary objective was to determine the effect of vitamin A alone vs. vitamin A and zinc supplements on the incidence of clinical malaria and other anthropometric indices .
OBJECTIVE	It also sought to assess the effects on the incidence of anaemia , diarrhoea and pneumonia .
METHODS	The study was community-based and 200 children between the ages of 6-24 months were randomised to receive either vitamin A ( 100,000 IU for infants less than 12 months & 200,000 IU for children greater than 12 months and 10 mg daily zinc in the intervention group or vitamin A and zinc placebo for 6 months in the control group .
RESULTS	The number of children who were diagnosed with uncomplicated malaria in the intervention group was 27 % significantly lower compared with the children in the control group ( p = 0.03 ) .
RESULTS	There were , however , no effects on severe malaria , pneumonia , anaemia and diarrhea .
CONCLUSIONS	Our study confirms a significant role of vitamin A and zinc in reducing malaria morbidity .

###24924703
BACKGROUND	Preventing and rehabilitating gait disorders in people with dementia during early disease stage is of high importance for staying independent and ambulating safely .
BACKGROUND	However , the evidence gathered in randomized controlled trials ( RCTs ) on the effectiveness of exercise training for improving spatio-temporal gait parameters in people with dementia is scarce .
BACKGROUND	The aim of the present study was to determine whether a specific , standardized training regimen can improve gait characteristics in people with dementia .
METHODS	Sixty-one individuals ( mean age : 81.9 years ) with confirmed mild to moderate stage dementia took part in a 3-month double-blinded outpatient RCT .
METHODS	Subjects in the intervention group ( IG ) received supervised , progressive resistance and functional group training for 3 months ( 2 times per week for two hours ) specifically developed for people with dementia .
METHODS	Subjects in the control group ( CG ) conducted a low-intensity motor placebo activity program .
METHODS	Gait characteristics were measured before and after the intervention period using a computerized gait analysis system ( GAITRite ) .
RESULTS	Adherence to the intervention was excellent , averaging 91.9 % in the IG and 94.4 % in the CG .
RESULTS	The exercise training significantly improved gait speed ( P < 0.001 ) , cadence ( P = 0.002 ) , stride length ( P = 0.008 ) , stride time ( P = 0.001 ) , and double support ( P = 0.001 ) in the IG compared to the CG .
RESULTS	Effect sizes were large for all gait parameters that improved significantly ( Cohen 's d : 0.80-1 .27 ) .
RESULTS	No improvements were found for step width ( P = 0.999 ) , step time variability ( P = 0.425 ) and Walk-Ratio ( P = 0.554 ) .
RESULTS	Interestingly , low baseline motor status , but not cognitive status , predicted positive training response ( relative change in gait speed from baseline ) .
CONCLUSIONS	The intensive , dementia-adjusted training was feasible and improved clinically meaningful gait variables in people with dementia .
CONCLUSIONS	The exercise program may represent a model for preventing and rehabilitating gait deficits in the target group .
CONCLUSIONS	Further research is required for improving specific gait characteristics such as gait variability in people with dementia .
BACKGROUND	ISRCTN49243245 .

###24667180
BACKGROUND	Palliative care patients and their family caregivers may have a foreshortened perspective of the time left to live , or the expectation of the patient 's death in the near future .
BACKGROUND	Patients and caregivers may report distress in physical , psychological , or existential/spiritual realms .
OBJECTIVE	To conduct a randomized controlled trial examining the effectiveness of retired senior volunteers ( RSVs ) in delivering a reminiscence and creative activity intervention aimed at alleviating palliative care patient and caregiver distress .
METHODS	Of the 45 dyads that completed baseline assessments , 28 completed postintervention and 24 completed follow-up assessments .
METHODS	The intervention group received three home visits by RSVs ; control group families received three supportive telephone calls by the research staff .
METHODS	Measures included symptom assessment and associated burden , depression , religiousness/spirituality , and meaning in life .
RESULTS	Patients in the intervention group reported a significantly greater reduction in frequency of emotional symptoms ( P = 0.02 ) and emotional symptom bother ( P = 0.04 ) than the control group , as well as improved spiritual functioning .
RESULTS	Family caregivers in the intervention group were more likely than control caregivers to endorse items on the Meaning of Life Scale ( P = 0.02 ) .
RESULTS	Only improvement in intervention patients ' emotional symptom bother maintained at follow-up after discontinuing RSV contact ( P = 0.024 ) .
CONCLUSIONS	Delivery of the intervention by RSVs had a positive impact on palliative care patients ' emotional symptoms and burden and caregivers ' meaning in life .
CONCLUSIONS	Meaningful prolonged engagement with palliative care patients and caregivers , possibly through alternative modes of treatment delivery such as continued RSV contact , may be necessary for maintenance of therapeutic effects .

###24849084
BACKGROUND	Postoperative pancreatic fistula is a major contributor to complications and death associated with pancreatic resection .
BACKGROUND	Pasireotide , a somatostatin analogue that has a longer half-life than octreotide and a broader binding profile , decreases pancreatic exocrine secretions and may prevent postoperative pancreatic fistula .
METHODS	We conducted a single-center , randomized , double-blind trial of perioperative subcutaneous pasireotide in patients undergoing either pancreaticoduodenectomy or distal pancreatectomy .
METHODS	We randomly assigned 300 patients to receive 900 g of subcutaneous pasireotide ( 152 patients ) or placebo ( 148 patients ) twice daily beginning preoperatively on the morning of the operation and continuing for 7 days ( 14 doses ) .
METHODS	Randomization was stratified according to the type of resection and whether the pancreatic duct was dilated at the site of transection .
METHODS	The primary end point was the development of pancreatic fistula , leak , or abscess of grade 3 or higher ( i.e. , requiring drainage ) .
RESULTS	The primary end point occurred in 45 of the 300 patients ( 15 % ) .
RESULTS	The rate of grade 3 or higher postoperative pancreatic fistula , leak , or abscess was significantly lower among patients who received pasireotide than among patients who received placebo ( 9 % vs. 21 % ; relative risk , 0.44 ; 95 % confidence interval [ CI ] , 0.24 to 0.78 ; P = 0.006 ) .
RESULTS	This finding was consistent among 220 patients who underwent pancreaticoduodenectomy ( 10 % vs. 21 % ; relative risk , 0.49 ; 95 % CI , 0.25 to 0.95 ) and 80 patients who underwent distal pancreatectomy ( 7 % vs. 23 % ; relative risk , 0.32 ; 95 % CI , 0.10 to 0.99 ) , as well as among 136 patients with a dilated pancreatic duct ( 2 % vs. 15 % ; relative risk , 0.11 ; 95 % CI , 0.02 to 0.60 ) and 164 patients with a nondilated pancreatic duct ( 15 % vs. 27 % ; relative risk , 0.55 ; 95 % CI , 0.29 to 1.01 ) .
CONCLUSIONS	Perioperative treatment with pasireotide decreased the rate of clinically significant postoperative pancreatic fistula , leak , or abscess .
CONCLUSIONS	( Funded by Novartis Pharmaceuticals ; ClinicalTrials.gov number , NCT00994110 . )

###25293665
OBJECTIVE	On the basis of phase II trials , we considered that transcranial laser therapy could have neuroprotective effects in patients with acute ischemic stroke .
METHODS	We studied transcranial laser therapy in a double-blind , sham-controlled randomized clinical trial intended to enroll 1000 patients with acute ischemic stroke treated 24 hours after stroke onset and who did not undergo thrombolytic therapy .
METHODS	The primary efficacy measure was the 90-day functional outcome as assessed by the modified Rankin Scale , with hierarchical Bayesian analysis incorporating relevant previous data .
METHODS	Interim analyses were planned after 300 and 600 patients included .
RESULTS	The study was terminated on recommendation by the Data Monitoring Committee after a futility analysis of 566 completed patients found no difference in the primary end point ( transcranial laser therapy 140/282 [ 49.6 % ] versus sham 140/284 [ 49.3 % ] for good functional outcome ; modified Rankin Scale , 0-2 ) .
RESULTS	The results remained stable after inclusion of all 630 randomized patients ( adjusted odds ratio , 1.024 ; 95 % confidence interval , 0.705-1 .488 ) .
CONCLUSIONS	Once the results of the interim futility analysis became available , all study support was immediately withdrawn by the capital firms behind PhotoThera , and the company was dissolved .
CONCLUSIONS	Proper termination of the trial was difficult but was finally achieved through special efforts by former employees of PhotoThera , the CRO Parexel and members of the steering and the safety committees .
CONCLUSIONS	We conclude that transcranial laser therapy does not have a measurable neuroprotective effect in patients with acute ischemic stroke when applied within 24 hours after stroke onset .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01120301 .

###25387728
BACKGROUND	The frailty syndrome is as a well-established condition of risk for disability .
BACKGROUND	Aim of the study is to explore whether a physical activity ( PA ) intervention can reduce prevalence and severity of frailty in a community-dwelling elders at risk of disability .
METHODS	Exploratory analyses from the Lifestyle Interventions and Independence for Elders pilot , a randomized controlled trial enrolling 424 community-dwelling persons ( mean age = 76.8 years ) with sedentary lifestyle and at risk of mobility disability .
METHODS	Participants were randomized to a 12-month PA intervention versus a successful aging education group .
METHODS	The frailty phenotype ( ie , 3 of the following defining criteria : involuntary weight loss , exhaustion , sedentary behavior , slow gait speed , poor handgrip strength ) was measured at baseline , 6 months , and 12 months .
METHODS	Repeated measures generalized linear models were conducted .
RESULTS	A significant ( p = .01 ) difference in frailty prevalence was observed at 12 months in the PA intervention group ( 10.0 % ; 95 % confidence interval = 6.5 % , 15.1 % ) , relative to the successful aging group ( 19.1 % ; 95 % confidence interval = 13.9 % ,15.6 % ) .
RESULTS	Over follow-up , in comparison to successful aging participants , the mean number of frailty criteria in the PA group was notably reduced for younger subjects , blacks , participants with frailty , and those with multimorbidity .
RESULTS	Among the frailty criteria , the sedentary behavior was the one most affected by the intervention .
CONCLUSIONS	Regular PA may reduce frailty , especially in individuals at higher risk of disability .
CONCLUSIONS	Future studies should be aimed at testing the possible benefits produced by multidomain interventions on frailty .

###25122448
OBJECTIVE	Past traumatic events have been associated with poorer clinical outcomes in people with bipolar disorder .
OBJECTIVE	However , the impact of these events in the early stages of the illness remains unclear .
OBJECTIVE	The aim of this study was to investigate whether prior traumatic events were related to poorer outcomes 12 months following a first episode of psychotic mania .
METHODS	Traumatic events were retrospectively evaluated from patient files in a sample of 65 participants who had experienced first episode psychotic mania .
METHODS	Participants were aged between 15 and 28 years and were treated at a specialised early psychosis service .
METHODS	Clinical outcomes were measured by a variety of symptomatic and functioning scales at the 12-month time-point .
RESULTS	Direct-personal traumatic experiences prior to the onset of psychotic mania were reported by 48 % of the sample .
RESULTS	Participants with past direct-personal trauma had significantly higher symptoms of mania ( p = 0.02 ) , depression ( p = 0.03 ) and psychopathology ( p = 0.01 ) 12 months following their first episode compared to participants without past direct-personal trauma , with medium to large effects observed .
RESULTS	After adjusting for baseline scores , differences in global functioning ( as measured by the Global Assessment of Functioning scale ) were non-significant ( p = 0.05 ) ; however , participants with past direct-personal trauma had significantly poorer social and occupational functioning ( p = 0.04 ) at the 12-month assessment with medium effect .
CONCLUSIONS	Past direct-personal trauma may predict poorer symptomatic and functional outcomes after first episode psychotic mania .
CONCLUSIONS	Limitations include that the findings represent individuals treated at a specialist early intervention centre for youth and the retrospective assessment of traumatic events may have been underestimated .

###26444692
OBJECTIVE	Saline ( 0.9 % sodium chloride ) is the most commonly administered intravenous fluid ; however , its use may be associated with acute kidney injury ( AKI ) and increased mortality .
OBJECTIVE	To determine the effect of a buffered crystalloid compared with saline on renal complications in patients admitted to the intensive care unit ( ICU ) .
METHODS	Double-blind , cluster randomized , double-crossover trial conducted in 4 ICUs in New Zealand from April 2014 through October 2014 .
METHODS	Three ICUs were general medical and surgical ICUs ; 1 ICU had a predominance of cardiothoracic and vascular surgical patients .
METHODS	All patients admitted to the ICU requiring crystalloid fluid therapy were eligible for inclusion .
METHODS	Patients with established AKI requiring renal replacement therapy ( RRT ) were excluded .
METHODS	All 2278 eligible patients were enrolled ; 1152 of 1162 patients ( 99.1 % ) receiving buffered crystalloid and 1110 of 1116 patients ( 99.5 % ) receiving saline were analyzed .
METHODS	Participating ICUs were assigned a masked study fluid , either saline or a buffered crystalloid , for alternating 7-week treatment blocks .
METHODS	Two ICUs commenced using 1 fluid and the other 2 commenced using the alternative fluid .
METHODS	Two crossovers occurred so that each ICU used each fluid twice over the 28 weeks of the study .
METHODS	The treating clinician determined the rate and frequency of fluid administration .
METHODS	The primary outcome was proportion of patients with AKI ( defined as a rise in serum creatinine level of at least 2-fold or a serum creatinine level of 3.96 mg/dL with an increase of 0.5 mg/dL ) ; main secondary outcomes were incidence of RRT use and in-hospital mortality .
RESULTS	In the buffered crystalloid group , 102 of 1067 patients ( 9.6 % ) developed AKI within 90 days after enrollment compared with 94 of 1025 patients ( 9.2 % ) in the saline group ( absolute difference , 0.4 % [ 95 % CI , -2.1 % to 2.9 % ] ; relative risk [ RR ] , 1.04 [ 95 % CI , 0.80 to 1.36 ] ; P = .77 ) .
RESULTS	In the buffered crystalloid group , RRT was used in 38 of 1152 patients ( 3.3 % ) compared with 38 of 1110 patients ( 3.4 % ) in the saline group ( absolute difference , -0.1 % [ 95 % CI , -1.6 % to 1.4 % ] ; RR , 0.96 [ 95 % CI , 0.62 to 1.50 ] ; P = .91 ) .
RESULTS	Overall , 87 of 1152 patients ( 7.6 % ) in the buffered crystalloid group and 95 of 1110 patients ( 8.6 % ) in the saline group died in the hospital ( absolute difference , -1.0 % [ 95 % CI , -3.3 % to 1.2 % ] ; RR , 0.88 [ 95 % CI , 0.67 to 1.17 ] ; P = .40 ) .
CONCLUSIONS	Among patients receiving crystalloid fluid therapy in the ICU , use of a buffered crystalloid compared with saline did not reduce the risk of AKI .
CONCLUSIONS	Further large randomized clinical trials are needed to assess efficacy in higher-risk populations and to measure clinical outcomes such as mortality .
BACKGROUND	clinicaltrials.gov Identifier : ACTRN12613001370796 .

###24812900
OBJECTIVE	To observe the clinical effect of Lingtong Capsule ( LC ) in treating primary dysmenorrhea ( PD ) .
METHODS	Totally 59 PD patients took LC , while 59 patients in the placebo group took placebo capsule , two pills immediately when they felt dysmenorrhea .
METHODS	Their pain levels were quantitatively classified .
METHODS	The pain score was assessed at an interval of 30 min using visual analogue scale/score ( VAS ) while taking medicine and within two h after taking medicine .
METHODS	It was assessed as effective when the pain level was reduced by more than or equal to 50 % within 2 h.
RESULTS	The total effective rate was 69.49 % ( 41 / 59 ) in the LC group and 20.34 % ( 12/59 ) in the placebo group ( P < 0.01 ) .
RESULTS	The analgesia effect was obviously superior in the LC group 60 min after taking medicine ( P < 0.01 ) .
RESULTS	LC showed better effect in treating mild , moderate , and severe PD ( P < 0.05 ) .
CONCLUSIONS	LC showed obvious analgesia effect on PD .

###24721668
BACKGROUND	Increased risk of osteoporosis and its clinical significance in patients with diabetes is controversial .
BACKGROUND	We analyze osteoporosis prevalence and determinants of bone mineral density ( BMD ) in patients with type 1 and 2 diabetes .
METHODS	Three hundred and ninety-eight consecutive diabetic patients from a single outpatient clinic received a standardized questionnaire on osteoporosis risk factors , and were evaluated for diabetes-related complications , HbA1c levels , and lumbar spine ( LS ) and femoral neck ( FN ) BMD .
METHODS	Of these , 139 ( 71 men , 68 women ) type 1 and 243 ( 115 men , 128 women ) type 2 diabetes patients were included in the study .
METHODS	BMD ( T-scores and values adjusted for age , BMI and duration of disease ) was compared between patient groups and between patients with type 2 diabetes and population-based controls ( 255 men , 249 women ) .
RESULTS	For both genders , adjusted BMD was not different between the type 1 and type 2 diabetes groups but was higher in the type 2 group compared with controls ( p < 0.0001 ) .
RESULTS	Osteoporosis prevalence ( BMD T-score < -2.5 SD ) at FN and LS was equivalent in the type 1 and type 2 diabetes groups , but lower in type 2 patients compared with controls ( FN : 13.0 % vs 21.2 % , LS : 6.1 % vs 14.9 % men ; FN : 21.9 % vs 32.1 % , LS : 9.4 % vs 26.9 % women ) .
RESULTS	Osteoporosis prevalence was higher at FN-BMD than at LS-BMD .
RESULTS	BMD was positively correlated with BMI and negatively correlated with age , but not correlated with diabetes-specific parameters ( therapy , HbBA1c , micro - and macrovascular complications ) in all subgroups .
RESULTS	Fragility fracture prevalence was low ( 5.2 % ) and not different between diabetes groups .
RESULTS	Fracture patients had lower BMDs compared with those without fractures ; however , BMD T-score was above -2.5 SD in most patients .
CONCLUSIONS	Diabetes-specific parameters did not predict BMD .
CONCLUSIONS	Fracture occurrence was similar in both diabetes groups and related to lower BMD , but seems unrelated to the threshold T-score , < -2.5 SD .
CONCLUSIONS	These results suggest that osteoporosis , and related fractures , is a clinically significant and commonly underestimated problem in diabetes patients .

###25264024
BACKGROUND	Lumbar punctures are frequently performed in pediatric leukemia for central nervous system leukemic prophylaxis .
BACKGROUND	The contribution of local anesthetic with deep sedation is unknown .
BACKGROUND	The objective was to evaluate EMLA ( eutectic mixture of local anesthetics ) cream as a pain reliever in conjunction with propofol in the setting of routine lumbar punctures .
METHODS	We included patients with acute lymphoblastic leukemia aged 3-21 years requiring at least two routine lumbar punctures .
METHODS	Patients were randomly assigned to receive EMLA or placebo cream and the alternate treatment with the second procedure .
METHODS	Patients , personnel and outcome assessors were blinded to allocation .
METHODS	The primary outcome included three indirect measures of pain : total median propofol doses , patient movement and heart rate changes at the time of skin puncture in both treatment groups .
RESULTS	Twenty-six patients were enrolled and 25 were analyzed .
RESULTS	With EMLA cream , 4 mg/kg ( median ) of propofol was required ( 95 % CI 3.5-4 .4 ) .
RESULTS	With placebo , 4.9 mg/kg of propofol was needed ( 95 % CI 4.3-5 .6 ; P = 0.008 ) .
RESULTS	When EMLA cream was applied , 8 % of patients moved , whereas 84 % moved with placebo cream ( P < 0.0001 ) .
RESULTS	There was a lower average heart rate by seven beats in the EMLA treatment compared to placebo ( 95 % CI -2.3 -4.3 ; 4.1-12 .4 ; P = 0.009 ) .
RESULTS	There were no adverse events in either treatment group .
CONCLUSIONS	This study demonstrated that the combination of EMLA cream with propofol is beneficial .
CONCLUSIONS	Topical analgesics are at the discretion of the oncologist , allowing us to advocate for patients by providing safe and efficacious pain management for lumbar punctures .

###24949549
BACKGROUND	We aimed to investigate effects of superoxide dismutase ( SOD ) - melon concentrate supplementation on psychological stress , physical and mental fatigue in healthy people .
METHODS	A randomized , double-blind , placebo-controlled trial was performed on 61 people divided in two groups : active supplement ( n = 32 ) and placebo ( n = 29 ) for 12 weeks .
METHODS	Volunteers were given one small hard capsule per day .
METHODS	One capsule contained 10 mg of SOD-melon concentrate ( 140 U of SOD ) and starch for the active supplement and starch only for the placebo .
METHODS	Stress and fatigue were evaluated using four psychometric scales : PSS-14 ; SF-36 ; Stroop tests and Prevost scale .
RESULTS	The supplementation with SOD-melon concentrate significantly decreased perceived stress , compared to placebo .
RESULTS	Moreover , quality of life was improved and physical and mental fatigue were reduced with SOD-melon concentrate supplementation .
CONCLUSIONS	SOD-melon concentrate supplementation appears to be an effective and natural way to reduce stress and fatigue .
BACKGROUND	trial approved by the ethical committee of Poitiers ( France ) , and the ClinicalTrials.gov Identifier is NCT01767922 .

###25747582
BACKGROUND	No consensus exists for the best way to monitor and when to trigger delivery in mothers of babies with fetal growth restriction .
BACKGROUND	We aimed to assess whether changes in the fetal ductus venosus Doppler waveform ( DV ) could be used as indications for delivery instead of cardiotocography short-term variation ( STV ) .
METHODS	In this prospective , European multicentre , unblinded , randomised study , we included women with singleton fetuses at 26-32 weeks of gestation who had very preterm fetal growth restriction ( ie , low abdominal circumference [ < 10th percentile ] and a high umbilical artery Doppler pulsatility index [ > 95th percentile ] ) .
METHODS	We randomly allocated women 1:1:1 , with randomly sized blocks and stratified by participating centre and gestational age ( < 29 weeks vs 29 weeks ) , to three timing of delivery plans , which differed according to antenatal monitoring strategies : reduced cardiotocograph fetal heart rate STV ( CTG STV ) , early DV changes ( pulsatility index > 95th percentile ; DV p95 ) , or late DV changes ( A wave [ the deflection within the venous waveform signifying atrial contraction ] at or below baseline ; DV no A ) .
METHODS	The primary outcome was survival without cerebral palsy or neurosensory impairment , or a Bayley III developmental score of less than 85 , at 2 years of age .
METHODS	We assessed outcomes in surviving infants with known outcomes at 2 years .
METHODS	We did an intention to treat study for all participants for whom we had data .
METHODS	Safety outcomes were deaths in utero and neonatal deaths and were assessed in all randomly allocated women .
METHODS	This study is registered with ISRCTN , number 56204499 .
RESULTS	Between Jan 1 , 2005 and Oct 1 , 2010 , 503 of 542 eligible women were randomly allocated to monitoring groups ( 166 to CTG STV , 167 to DV p95 , and 170 to DV no A ) .
RESULTS	The median gestational age at delivery was 307 weeks ( IQR 291-321 ) and mean birthweight was 1019 g ( SD 322 ) .
RESULTS	The proportion of infants surviving without neuroimpairment did not differ between the CTG STV ( 111 [ 77 % ] of 144 infants with known outcome ) , DV p95 ( 119 [ 84 % ] of 142 ) , and DV no A ( 133 [ 85 % ] of 157 ) groups ( ptrend = 009 ) .
RESULTS	12 fetuses ( 2 % ) died in utero and 27 ( 6 % ) neonatal deaths occurred .
RESULTS	Of survivors , more infants where women were randomly assigned to delivery according to late ductus changes ( 133 [ 95 % ] of 140 , 95 % , 95 % CI 90-98 ) were free of neuroimpairment when compared with those randomly assigned to CTG ( 111 [ 85 % ] of 131 , 95 % CI 78-90 ; p = 0.005 ) , but this was accompanied by a non-significant increase in perinatal and infant mortality .
CONCLUSIONS	Although the difference in the proportion of infants surviving without neuroimpairment was non-significant at the primary endpoint , timing of delivery based on the study protocol using late changes in the DV waveform might produce an improvement in developmental outcomes at 2 years of age .
BACKGROUND	ZonMw , The Netherlands and Dr Hans Ludwig Geisenhofer Foundation , Germany .

###25062131
OBJECTIVE	To compare corneal stromal and endothelial cells after photorefractive keratectomy with intraoperative mitomycin C in alcohol-assisted versus mechanical epithelial debridement using confocal microscopy .
METHODS	This prospective randomized comparative study was performed on 88 eyes ( 44 patients ) with myopia up to -6.00 diopters .
METHODS	The right eye of each patient was randomly assigned to either mechanical or alcohol-assisted groups , and the left eye was assigned to the alternate group .
METHODS	Confocal microscopy was performed preoperatively and at 3 months postoperatively .
METHODS	The main outcome measures were epithelial thickness ; number of keratocytes in the anterior , mid - , and posterior stroma ; and characteristics of the central corneal endothelial cells in terms of density , mean cell area , and polymegathism and hexagonality .
RESULTS	Three months after surgery , no statistically significant difference was noted between the study groups in terms of epithelial thickness .
RESULTS	We also found no statistically significant difference in central corneal endothelial cells regarding cell density , mean cell area , hexagonality , or polymegathism .
RESULTS	Compared with baseline values , the density of mid - and posterior stromal keratocytes showed no significant change in either group , whereas it decreased significantly in the anterior stroma in both groups 3 months after surgery .
CONCLUSIONS	We found that the adverse effects of photorefractive keratectomy with mitomycin C on central corneal endothelial cells were comparable between the mechanical and alcohol-assisted epithelial debridement groups and the significant decrease in postoperative keratocyte density in anterior stroma was comparable between the two groups .
CONCLUSIONS	The choice of their application could be left to the discretion of the ophthalmologist .

###25539976
BACKGROUND	The transition from pediatric to nephrology care is not yet a standardized procedure .
BACKGROUND	The result is an increased risk of deteriorating transplant function , with the potential for premature transplant failure .
METHODS	In phase I of this study , we shall evaluate the current patient transition situation in all existing German pediatric and nephrology departments ( n = 17 ) , including an evaluation of the views of physicians , nurses , and psychosocial support staff regarding transition .
METHODS	Phase II will be a prospective , randomized study in which we compare current unstructured transition ( control group ) to structured transition ( intervention group ) .
METHODS	The structured transition approach integrates the core elements of the Berliner TransitionsProgramm in combination with two facilitating smartphone apps .
METHODS	The primary endpoint of this study will be therapy adherence , as reflected by group variation coefficients of immunosuppressive agent levels .
METHODS	As a secondary outcome , we will compare patients ' self-reported quality of life , satisfaction of patients and their parents with each transition model , and how patient-centered healthcare components are utilized .
METHODS	These secondary parameters will be assessed with established instruments or with instruments developed ( and pilot tested ) in phase I of the project .
CONCLUSIONS	The long-term goal of this work is to provide a model of structured transition from pediatric to adult care for adolescent nephrology patients , in order to improve transplant survival and patient wellbeing .
BACKGROUND	Identifier : Clinicaltrials.gov : ISRCTN22988897 , registered on 24 April 2014 ) .

###25778317
OBJECTIVE	To explore the clinical efficacy of radiotherapy combined with concurrent combination chemotherapy in the treatment of patients with advanced nasopharyngeal carcinoma ( NPC ) .
METHODS	Two hundred patients with stage III/IV NPC were randomly allocated into the treatment group ( N = 100 ) and the control group ( N = 100 ) .
METHODS	Patients in the control group received conventional fractionated radiotherapy , while patients in the treatment group received conventional fractionated radiotherapy combined with concurrent combination chemotherapy with cisplatin and 5-fluorouracil ( 5-FU ) .
METHODS	Short-term efficacy , radiotherapy toxicity , shortand long-term survival were compared .
RESULTS	The short-term response rate of the treatment group was 96 % , which was significantly higher than that of the control group ( 87 % , p < 0.05 ) .
RESULTS	The local radiation toxicity of the treatment group was similar to that of the control group p > 0.05 ) , but the hematological and gastrointestinal toxicities were significantly higher in the treatment group p < 0.05 ) .
RESULTS	The 1 - , 3 - and 5-year overall survival rates were 87 , 80 , and 76 % , respectively , in the treatment group and 74 , 64 , and 51 % , respectively , in the control group , significantly favoring the treatment group p < 0.05 ) .
CONCLUSIONS	Radiotherapy with concurrent combination chemotherapy can improve the prognosis of patients with advanced NPC but at the cost of significant toxicity .

###24575797
OBJECTIVE	To determine the induction doses , then minimum infusion rates of alfaxalone for total intravenous anaesthesia ( TIVA ) , and subsequent , cardiopulmonary effects , recovery characteristics and alfaxalone plasma concentrations in cats undergoing ovariohysterectomy after premedication with butorphanol-acepromazine or butorphanol-medetomidine .
METHODS	Prospective randomized blinded clinical study .
METHODS	Twenty-eight healthy cats .
METHODS	Cats undergoing ovariohysterectomy were assigned into two groups : together with butorphanol [ 0.2 mgkg ( -1 ) intramuscularly ( IM ) ] , group AA ( n = 14 ) received acepromazine ( 0.1 mgkg ( -1 ) IM ) and group MA ( n = 14 ) medetomidine ( 20gkg ( -1 ) IM ) .
METHODS	Anaesthesia was induced with alfaxalone to effect [ 0.2 mgkg ( -1 ) intravenously ( IV ) every 20seconds ] , initially maintained with 8mgkg ( -1 ) hour ( -1 ) alfaxalone IV and infusion adjusted ( 0.5 mg kg ( -1 ) hour ( -1 ) ) every five minutes according to alterations in heart rate ( HR ) , respiratory rate ( fR ) , Doppler blood pressure ( DBP ) and presence of palpebral reflex .
METHODS	Additional alfaxalone boli were administered IV if cats moved/swallowed ( 0.5 mgkg ( -1 ) ) or if fR > 40 breaths minute ( -1 ) ( 0.25 mgkg ( -1 ) ) .
METHODS	Venous blood samples were obtained to determine plasma alfaxalone concentrations .
METHODS	Meloxicam ( 0.2 mgkg ( -1 ) IV ) was administered postoperatively .
METHODS	Data were analysed using linear mixed models , Chi-squared , Fishers exact and t-tests .
RESULTS	Alfaxalone anaesthesia induction dose ( meanSD ) , was lower in group MA ( 1.870.5 ; group AA : 2.570.41 mgkg ( -1 ) ) .
RESULTS	No cats became apnoeic .
RESULTS	Intraoperative bolus requirements and TIVA rates ( group AA : 11.621.37 , group MA : 10.760.96 mgkg ( -1 ) hour ( -1 ) ) did not differ significantly between groups .
RESULTS	Plasma concentrations ranged between 0.69 and 10.76 gmL ( -1 ) .
RESULTS	In group MA , fR , end-tidal carbon dioxide , temperature and DBP were significantly higher and HR lower .
CONCLUSIONS	Alfaxalone TIVA in cats after medetomidine or acepromazine sedation provided suitable anaesthesia with no need for ventilatory support .
CONCLUSIONS	After these premedications , the authors recommend initial alfaxalone TIVA rates of 10mg kg ( -1 ) hour ( -1 ) .

###24590644
OBJECTIVE	Zoledronic acid decreases the risk for skeletal-related events ( SREs ) in men with castration-resistant prostate cancer and bone metastases but its role earlier in the natural history of the disease is unknown .
OBJECTIVE	This phase III study evaluated the efficacy and safety of earlier treatment with zoledronic acid in men with castration-sensitive metastatic prostate cancer .
METHODS	Men with castration-sensitive prostate cancer and bone metastases whose androgen-deprivation therapy was initiated within 6 months of study entry were randomly assigned in a blinded 1:1 ratio to receive zoledronic acid ( 4 mg intravenously every 4 weeks ) or a placebo .
METHODS	After their disease progressed to castration-resistant status , all patients received open-label treatment with zoledronic acid .
METHODS	The primary end point was time to first SRE , defined as radiation to bone , clinical fracture , spinal cord compression , surgery to bone , or death as a result of prostate cancer .
METHODS	Target accrual was 680 patients .
METHODS	Primary analysis was planned after 470 SREs .
METHODS	The study was discontinued prematurely ( 645 patients ; 299 SREs ) after the corporate supporter withdrew study drug supply .
RESULTS	Early zoledronic acid was not associated with increased time to first SRE .
RESULTS	The median time to first SRE was 31.9 months in the zoledronic acid group ( 95 % CI , 24.2 to 40.3 ) and 29.8 months in the placebo group ( 95 % CI , 25.3 to 37.2 ; hazard ratio , 0.97 ; 95 % CI , 0 to 1.17 ; one-sided stratified log-rank P = .39 ) .
RESULTS	Overall survival was similar between the groups ( hazard ratio , 0.88 ; 95 % CI , 0.70 to 1.12 ; P = .29 ) .
RESULTS	Rates of adverse events were similar between the groups .
CONCLUSIONS	In men with castration-sensitive prostate cancer and bone metastases , early treatment with zoledronic acid was not associated with lower risk for SREs .

###25027493
BACKGROUND	About 45 % of all pregnant women suffer low back pain and/or pelvic girdle pain ( LBPGP ) .
BACKGROUND	This study seeks to evaluate the effect of auricular acupuncture on LBPGP compared with placebo auricular acupuncture and with standard obstetric care in the field of primary health care .
METHODS	This study will be a four-parallel-arm , multicentre , randomised , placebo-controlled trial .
METHODS	A total of 212 pregnant women ( 24 to 36weeks ' gestation ) , aged at least 17years , with LBPGP , will be randomly assigned to the verum auricular acupuncture plus standard obstetric care group ( VAAc ) , to the non-specific auricular acupuncture plus standard obstetric care group ( NSAAc ) , to the non-specific placebo auricular acupuncture plus standard obstetric care group ( PAAc ) , or the standard obstetric care group ( SOC ) .
METHODS	The VAAc , NSAAc , and PAAc groups will receive treatment at three auricular acupuncture points ( specific points for the VAAc group or non-specific ones for the NSAAc and PAAc groups ) , once a week for 2weeks ; the SOC group will receive only standard obstetric care during the same period .
METHODS	The primary outcome will be the reduction in pain intensity , according to the visual analogue scale ( iVAS ) , at 2weeks after the start of treatment .
METHODS	The secondary outcomes will be functional status with respect to LBPGP ( according to the Roland-Morris disability questionnaire ) , health-related quality of life ( SF12 ) at 2weeks after the start of treatment , and iVAS at 12 and 48weeks postpartum .
CONCLUSIONS	This trial will implement a high-quality methodology and may provide evidence for the efficacy , safety , and specificity of auricular acupuncture as a treatment for pregnant women with LBPGP .
BACKGROUND	Current Controlled Trials ISRCTN41033073 ( date 20/03/2014 ) .

###25233668
OBJECTIVE	To explore safe , effective , simple and easy non-drug treatments for grade 1 essential hypertension .
METHODS	According to TCM syndrome differentiation , 126 cases of grade 1 essential hypertension were classified into 4 types : liver-fire hyperactivity syndrome , yin-deficiency and yang-hyperactivity syndrome , excessive phlegm-dampness syndrome , yin-yang deficiency syndrome , and then the patients were randomly divided into a photoelectric combined with musical treatment group ( group A ) , an acupuncture group ( group B ) and a placebo group ( group C ) .
METHODS	The acupoints were selected according to TCM syndrome differentiation in group A and group B , and multi-mode audio frequency pulse photoelectric therapeutic apparatus and acupuncture were used in the two groups respectively , once daily .
METHODS	Taichong ( LR 3 ) and Quchi ( LI 11 ) were selected in liver-fire hyperactivity syndrome , Taixi ( KI 3 ) and Sanyinjiao ( SP 6 ) were selected yi yin-deficiency and yang-hyperactivity syndrome , Zusanli ( ST 36 ) and Fenglong ( ST 40 ) were selected in excessive phlegm-dampness syndrome , while Taixi ( KI 3 ) and Guanyuan ( CV 4 ) were selected yi yirryang deficiency syndrome .
METHODS	The group C was treated with oral administration of starch tablet ( 25 mg ) , one tablet each time , three times everyday .
METHODS	Ten days were considered as one course , totally three courses were required in the three groups .
METHODS	The blood pressure and scores of TCM syndromes before and after treatment were compared among the three groups .
RESULTS	The blood pressure decreased significantly after treatment in group A and group B ( all P < 0.01 ) , and the decrease in systolic blood pressure was more significant in group A ( P < 0.05 ) .
RESULTS	The total effective rate was 90.5 / ( 38/42 ) in group A , which was superior to 71.4 ( 30/42 , P < 0.05 ) in group B and 19.1 % ( 18/34 , P < 0.01 ) in group C.
RESULTS	The scores of TCM syndromes were both improved in group A and group B , but without significant difference between the two groups ( P > 0.05 ) .
CONCLUSIONS	The clinical effect of multi-mode audio frequency pulse photoelectric therapeutic apparatus for treatment of grade 1 essential hypertension is reliable .
CONCLUSIONS	Meanwhile , it has the advantages of a non-invasive and simple operation .

###24839916
OBJECTIVE	To evaluate the efficacy of adding folic acid to oral iron supplementation in postpartum women with anemia .
METHODS	A randomized controlled trial was conducted in the Netherlands between April 8 , 2008 , and August 31 , 2010 .
METHODS	A total of 112 postpartum women with anemia ( hemoglobin < 10.5 g/dL ) were randomly allocated to receive 600 mg/day ferrous fumarate plus 1mg/day folic acid ( FFFA group ) or 600/day ferrous fumarate alone ( FF group ) for 4 weeks .
METHODS	Primary outcome measures were hemoglobin and health status .
METHODS	Secondary outcome measures were fatigue , compliance , and adverse reactions .
RESULTS	No between-group differences were observed in hemoglobin and health status after treatment , and no differences were found in fatigue scores .
RESULTS	Approximately 75 % of all women reported having at least one symptom resulting from ferrous fumarate use .
RESULTS	Constipation caused by ferrous fumarate was significantly associated with non-compliance ( P = 0.014 ) .
CONCLUSIONS	The addition of folic acid to iron supplementation is not beneficial in women with postpartum anemia , as it has no effect on hematologic or health status parameters .
BACKGROUND	CCMO website NL21797 .028.08 and Netherlands Trial Register NTR2232 .

###25829422
OBJECTIVE	Data show that many research subjects have difficulty understanding study information using traditional paper consent documents .
OBJECTIVE	This study , therefore , was designed to evaluate the effect of an interactive multimedia program on improving parents ' and children 's understanding of clinical trial concepts and participation .
METHODS	Parents ( n = 148 ) and children ( n = 135 ) were each randomised to receive information regarding clinical trials using either a traditional paper format ( TF ) or an interactive iPad program ( IP ) with inline exercises .
METHODS	Participants ' understanding of the information was assessed using semistructured interviews prior to ( pretest ) and after ( post-test ) receiving the information .
METHODS	Participants also completed a short survey to assess their perceptions of information delivery and satisfaction with the process .
RESULTS	Regardless of the mode of information delivery , all participants demonstrated improved pretest to post-test understanding .
RESULTS	While there were no statistical differences in parents ' post-test understanding between the TF and IP groups , children in the IP group had significantly greater post-test understanding compared with children in the TF group ( 11.65 ( 4.1 ) vs 8.85 ( 4.1 ) ( 2.8 , 1.4 , 4.2 ) 0-18 scale where 18 = complete understanding ) .
RESULTS	Furthermore , the IP was found to be significantly ` easier to follow ' and ` more effective ' in presenting information compared with the TF .
CONCLUSIONS	Results demonstrated the importance of providing information regarding clinical trial concepts to parents and children .
CONCLUSIONS	Importantly , the ability of interactive multimedia to improve understanding of clinical trial concepts and satisfaction with information delivery , particularly among children , supports this approach as a novel and effective vehicle for enhancing the informed consent process .

###25580840
BACKGROUND	Many cancer patients report unmet rehabilitation needs .
BACKGROUND	Rehabilitation may include activities of daily living ( ADL ) tasks , but little is known about how cancer patients perform these tasks and how they prioritize their daily activities .
BACKGROUND	Hence , this study aims to identify and characterize ADL task performance problems among a group of adult disabled hospitalized cancer patients using interview and questionnaire data .
METHODS	Cross-sectional study on prevalence of ADL task performance problems experienced by disabled hospitalized cancer patients using the Activities of Daily Living Questionnaire ( ADL-Q ) ( n = 118 ) and the Canadian Occupational Performance Measure ( COPM ) ( n = 55 ) .
RESULTS	All 118 patients reported problems with ADL task performance .
RESULTS	Based on the ADL-Q patients reported more problems within instrumental ( I - ) ADL than personal ( P - ) ADL .
RESULTS	In both I-ADL and P-ADL the results differed between women and men .
RESULTS	There was significant overlap between problems identified using the COPM and the ADL-Q instruments .
RESULTS	RESULTS from the COPM showed that 65 % of problems were related to self-care , 25 % to leisure , and 19 % to productivity .
RESULTS	Using both instruments identified more ADL problems than when using only one of the instruments .
CONCLUSIONS	Adult hospitalized disabled cancer patients experience a high degree and variation in difficulties performing ADL , illustrating the need for a comprehensively planned assessment of problems and needs .

###25884343
OBJECTIVE	Long-term follow-up study is required for verifying whether the clinical outcomes of kyphoplasty and vertebroplasty are altered .
OBJECTIVE	The authors ' findings showed only subtle differences between these operations within a 5-year period .
OBJECTIVE	However , they still suggest the use of vertebroplasty over kyphoplasty in view of the treatment costs .
OBJECTIVE	In their previous study , the authors performed a short-term prospective comparison between vertebroplasty and kyphoplasty .
OBJECTIVE	Vertebroplasty was recommended instead of kyphoplasty for the treatment of vertebral compression fractures ( VCFs ) because of the subtle differences between this procedure and kyphoplasty and the treatment costs .
OBJECTIVE	To determine whether these clinical outcomes persist in the long term , they continued to observe the patients from their short-term study over a longer-term period .
OBJECTIVE	METHODS : One hundred cases of VCF were assigned randomly to either the kyphoplasty or the vertebroplasty group .
OBJECTIVE	In cement augmentation , the authors used polymethylmethacrylate as bone filler .
OBJECTIVE	Pain was assessed by using a visual analog scale ( VAS ) .
OBJECTIVE	For each patient , vertebral body height and wedge angle were measured from reconstructed CT images .
RESULTS	The duration of the follow-up period was 5 years .
RESULTS	Vertebral body height , kyphotic wedge angle , and VAS score were not evidently altered .
RESULTS	Eight patients in the kyphoplasty group had an adjacent fracture after the procedure , whereas 7 patients in the vertebroplasty group had an adjacent fracture after the procedure .
RESULTS	These adjacent fractures occurred within 1 year of surgery in both treatment groups except in 1 kyphoplasty-treated patient in whom the adjacent fracture was noted 16 months after treatment .
RESULTS	Three patients in the vertebroplasty group had a nonadjacent fracture , and 4 patients in the kyphoplasty group had a nonadjacent fracture .
RESULTS	The link between angular correction and the occurrence of adjacent fracture was statistically significant in the vertebroplasty group .
CONCLUSIONS	Excessive angular correction is a critical concern in the risk of adjacent fracture after vertebroplasty .
CONCLUSIONS	Given the subtle differences between vertebroplasty and kyphoplasty observed over the course of 5 years , vertebroplasty remains the preferred option in view of the costs .

###24947656
OBJECTIVE	To determine the rate of cervical intraepithelial neoplasia grade 2 ( CIN2 + ) in women with low grade cervical cytology and a normal colposcopy examination over 3 years of follow-up .
METHODS	Cohort study within a randomised controlled trial .
METHODS	NHS Cervical Screening Programmes in Grampian , Tayside and Nottingham .
METHODS	Eight hundred and eighty-four women aged 20-59 years with borderline nuclear abnormalities ( BNA ) or mild dyskaryosis with a normal and adequate colposcopy examination .
METHODS	Samples at baseline were tested for 14 high-risk ( Hr ) types using GP5 +6 + methodology and for HPV 16 and 18 using type-specific primers .
METHODS	Women were followed up post-colposcopy by cervical cytology at 6-month intervals in primary care .
METHODS	After 3 years , women were invited for an exit colposcopy examination and underwent LLETZ if any colposcopic abnormality was identified .
METHODS	Absolute and relative risks of CIN2 + during follow-up and/or at exit colposcopy .
RESULTS	The median age was 36 years .
RESULTS	The absolute risk of developing CIN2 + within 3 years was 1.86 per 100 woman years and for CIN3 + , 0.64 per 100 woman years .
RESULTS	One microinvasive cancer was identified .
RESULTS	The relative risk ( RR ) was highest for women with initial mild dyskaryosis who were HrHPV-positive ( RR 5.86 , 95 % confidence interval 2.53-13 .56 ) compared with women with BNA who were HrHPV-negative .
CONCLUSIONS	For women with low grade cervical cytology , the risk of a high grade CIN within 3 years of a normal colposcopy examination is low .
CONCLUSIONS	Women can be reassured that , even with a positive HPV test , the risk of developing CIN2 or worse is sufficiently low to return to the routine 3-year recall .

###24322191
BACKGROUND	Constipation is a very common symptom in the general population .
BACKGROUND	One way of non-pharmacological treatment of constipation is through the addition of probiotics to food .
OBJECTIVE	The aim of this study was to evaluate de effect of the consumption of a fresh cheese , enriched with Bifidobacterium lactis Bi-07 on the symptoms of constipated women .
METHODS	A randomized controlled trial , carried out in the Basic Health Units of Guapor 's City - RS/Brazil , between January and May 2012 , with 30 constipated women .
METHODS	The patients were randomized into two groups whom received , for 30 days , 30 g of fresh cheese enriched with Bifidobacterium lactis Bi-07 ( n = 15 ) or regular fresh cheese ( n = 15 ) .
METHODS	Constipation symptoms were evaluated according to ROMA III Consensus , before and after the nutritional intervention .
METHODS	Also , data of clinical and anthropometric characteristics of the individuals were collected .
METHODS	Accepted level of significance 5 % ( P0 ,05 ) .
RESULTS	The medium age of the studied population was 37,514,4 years in the intervention group and 40,812,8 years in the control group .
RESULTS	After 30 days we observed that the ingestion of fresh cheese enriched with Bifidobacterium lactis Bi-07 promoted benefic effects on the symptoms of strength to evacuate .
CONCLUSIONS	The consumption of 30g/day of a fresh cheese enriched with Bifidobacterium lactis Bi-07 has beneficial effects on constipation symptoms .

###25908395
BACKGROUND	There is a need to improve participation in colorectal cancer screening .
BACKGROUND	Our objective was to assess the impact of a signature from the patient 's general practitioner on a letter inviting patients to participate in a colorectal cancer screening .
METHODS	We conducted a cluster randomized controlled trial with 57 general practitioners established in Paris for more than 5 years , randomized to intervention or usual-care arms .
METHODS	There were 3422 patients included , ages 50-74 years , from general practitioner patient files , and eligible for an invitation letter or a reminder letter to participate in the national population-based screening program .
METHODS	In the intervention arm , patients received a standard letter signed by their general practitioner inviting them to visit the general practitioner 's office for a fecal occult blood test if they were eligible .
METHODS	Control patients received the standard invitation letter or the standard reminder .
METHODS	All letters were sent by the district screening organization .
METHODS	The main outcome was the proportion of patients who took the fecal occult blood test within 6 months after the invitation .
RESULTS	Among patients eligible for the study , 508 ( 14.8 % ) took a fecal occult blood test after being invited ; 285 ( 15 % ; 95 % confidence interval [ CI ] , 13.5-16 .7 ) in the intervention group and 223 ( 14.6 % ; 95 % CI , 12.9-16 .5 ) in the control group , with no statistical difference between the 2 groups ( odds ratio 1.04 ; 95 % CI , 0.83-1 .31 ; P = .731 ) .
CONCLUSIONS	The addition of a general practitioner 's signature to a standard letter inviting patients to take a fecal occult blood test had no impact on the frequency of patients taking the fecal occult blood test in the Paris program of colorectal cancer screening .

###25219128
OBJECTIVE	To observe the therapeutic effect of acupuncture and moxibustion interventions in the treatment of chronic fatigue syndrome ( CFS ) .
METHODS	A total of 133 CFS patients were randomized into acupuncture group ( 47 cases ) , warm-needling group ( 44 cases ) and non-acupoint group ( 42 cases ) .
METHODS	Manual acupuncture ( MA ) stimulation was applied to Baihui ( GV 20 ) , Danzhong ( CV 17 ) , Qihai ( CV 6 ) , Guanyuan ( CV 4 ) , bilateral Zusanli ( ST 36 ) , Hegu ( LI 4 ) , Taichong ( LR 3 ) and Sanyinjiao ( SP 6 ) for patients in the acupuncture group .
METHODS	For patients in the warm-needling group , moxa-heated needle was applied to Baihui ( GV 20 ) , Qihai ( CV 6 ) , Guanyuan ( CV 4 ) and bilateral Zusanli ( ST 36 ) .
METHODS	Non-acupoints were located about 1-2 cm beside the Baihui ( GV 20 ) , Danzhong ( CV 17 ) , Qihai ( CV 6 ) , Guanyuan ( CV 4 ) , Zusanli ( ST 36 ) , Taichong ( LR 3 ) , Sanyinjiao ( SP 6 ) and Hegu ( LI 4 ) .
METHODS	The treatment was given once daily for 20 days .
METHODS	The Chalder Fatigue Scale ( 14-item fatigue scale ) was adopted to evaluate the changes of CFS before and after the treatment .
RESULTS	In comparison with pre-treatment , the scores of Chalder Fatigue Scale including physical and mental fatigue and total score were significantly decreased in both acupuncture and warm-needling groups ( P < 0.05 , P < 0.01 ) , but not in the non-acupoint group ( P > 0.05 ) except physical score ( P < 0.05 ) .
RESULTS	The physical , mental and total scores of the acupuncture and warm-needling groups were significantly lower than those of the non-acupoint group ( P < 0.05 , P < 0.01 ) , while the physical and total scores of the warm-needling group were markedly lower than those of the acupuncture group ( P < 0.05 ) .
RESULTS	After the treatment , the CFS patients ' satisfactory rates of the acupuncture , warm-needling and non-acupoint groups were 36.2 % ( 17/47 ) , 72.7 % ( 32/44 ) and 35.7 % ( 15/42 ) , respectively .
CONCLUSIONS	Both MA and warm-needling interventions have a good therapeutic effect in the treatment of CFS patients , while the latter is obviously better .

###25951907
OBJECTIVE	To test the effectiveness of a programme aimed at reducing the risky use of alcohol and alcohol-related HIV risk and increase help-seeking behaviour among a sample of municipal employees in the Western Cape Province , South Africa .
METHODS	A clustered randomised controlled trial was conducted in 2011-2012 among 325 employees .
METHODS	The eight hour intervention , Team Awareness ( TA ) , addressing behavioural risk among employees was administered to 168 employees in the intervention arm and the 157 employees in the control arm who received a one-hour wellness talk .
RESULTS	The results show that TA had the greatest impact on risky drinking practices and hangover effects .
RESULTS	There was a significant group time interaction ( F ( 1 , 117 ) = 25.16 , p < 0.0001 ) with participants in the intervention condition reducing number of days on which they engaged in binge drinking .
RESULTS	There was also a significant time effect with participants in the intervention condition reducing the likelihood of going to work with a hangover ( F ( 1,117 ) = 4.10 , p = 0.045 ) .
RESULTS	No reduction in HIV-related risk behaviours were found .
CONCLUSIONS	This intervention study was able to demonstrate a modest but significant reduction in risky drinking practices and hangover effects .
CONCLUSIONS	This provides encouraging evidence for the effectiveness of interventions that address risky use of alcohol among employed persons , further providing a launch pad for strengthening and replicating future RCT studies on workplace prevention , especially in developing country settings .
BACKGROUND	Pan-African Control Trial Registry ( 201301000458308 ) .

###24823456
BACKGROUND	Insufficient sleep is associated with increased cardiometabolic risk .
BACKGROUND	Alterations in hypothalamic-pituitary-adrenal axis may underlie this link .
OBJECTIVE	Our objective was to examine the impact of restricted sleep on daytime profiles of ACTH and cortisol concentrations .
METHODS	Thirteen subjects participated in 2 laboratory sessions ( 2 nights of 10 hours in bed versus 2 nights of 4 hours in bed ) in a randomized crossover design .
METHODS	Sleep was polygraphically recorded .
METHODS	After the second night of each session , blood was sampled at 20-minute intervals from 9:00 am to midnight to measure ACTH and total cortisol .
METHODS	Saliva was collected every 20 minutes from 2:00 pm to midnight to measure free cortisol .
METHODS	Perceived stress , hunger , and appetite were assessed at hourly intervals by validated scales .
RESULTS	Sleep restriction was associated with a 19 % increase in overall ACTH levels ( P < .03 ) that was correlated with the individual amount of sleep loss ( rSp = 0.63 , P < .02 ) .
RESULTS	Overall total cortisol levels were also elevated ( +21 % ; P = .10 ) .
RESULTS	Pulse frequency was unchanged for both ACTH and cortisol .
RESULTS	Morning levels of ACTH were higher after sleep restriction ( P < .04 ) without concomitant elevation of cortisol .
RESULTS	In contrast , evening ACTH levels were unchanged while total and free cortisol increased by , respectively , 30 % ( P < .03 ) and 200 % ( P < .04 ) .
RESULTS	Thus , the amplitude of the circadian cortisol decline was dampened by sleep restriction ( -21 % ; P < .05 ) .
RESULTS	Sleep restriction was not associated with higher perceived stress but resulted in an increase in appetite that was correlated with the increase in total cortisol .
CONCLUSIONS	The impact of sleep loss on hypothalamic-pituitary-adrenal activity is dependent on time of day .
CONCLUSIONS	Insufficient sleep dampens the circadian rhythm of cortisol , a major internal synchronizer of central and peripheral clocks .

###24300544
OBJECTIVE	Inflammation and coagulation biomarkers interleukin ( IL ) -6 and D-dimer are predictive of all-cause mortality in chronic HIV-1 infection ; however , their predictive value in individuals with recent infection has not been described .
METHODS	SPARTAC was a randomized controlled trial comparing three strategies of intervention in primary HIV-1 infection [ no therapy , 12-week or 48-week antiretroviral therapy ( ART ) ] .
METHODS	Plasma IL-6 and D-dimer were measured in 200 participants from sites in Australia , Brazil , UK and Italy .
METHODS	We evaluated age , sex/HIV risk group , time since HIV-1 seroconversion , baseline HIV-RNA , CD4 cell count and BMI as possible predictors of IL-6 and D-dimer levels at seroconversion using multivariable linear regression .
METHODS	For participants remaining ART-naive , we evaluated whether baseline IL-6 and D-dimer levels independently predicted time to reaching CD4 cell count less than 350 cells/l or initiating ART using multivariable Cox proportional hazards models .
RESULTS	Median ( interquartile range , IQR ) baseline IL-6 and D-dimer levels were 1.45 ( 0.88-2 .41 ) pg/ml and 0.34 ( 0.20-0 .50 ) g/l , respectively .
RESULTS	Higher levels were associated with older age ( P = 0.008 and 0.004 , respectively ) .
RESULTS	Higher D-dimer levels were associated with higher HIV-RNA ( P < 0.001 ) .
RESULTS	For the 73 participants not initiating ART ( median follow-up 225 weeks ) , of whom 48 reached the primary endpoint , higher baseline IL-6 , but not D-dimer , was independently associated with a shorter time to primary endpoint [ hazard ratio = 1.38 per additional pg/ml , 95 % confidence interval ( CI ) 1.09-1 .75 ; P = 0.007 ] .
RESULTS	Other baseline predictors were older age ( P = 0.030 ) , higher RNA ( P = 0.033 ) and lower CD4 cell count ( P < 0.001 ) .
CONCLUSIONS	IL-6 levels at time of HIV-1 seroconversion independently predict HIV-1 disease progression in patients with primary HIV-1 infection .

###24791969
BACKGROUND	The incidence of propofol injection pain is high in children , but no methods have been found to suppress it completely .
BACKGROUND	This study intends to evaluate the efficacy of dexmedetomidine-midazolam in preventing propofol injection pain in children .
METHODS	One-hundred ASA I patients , aged 3-12 years , weighing 15-53 kg , undergoing elective surgery were randomized into two groups of 50 each , using computer-generated random numbers .
METHODS	Normal saline 0.15 ml/kg in Group C or dexmedetomidine 0.6 g/kg in Group D was infused IV over 10 min .
METHODS	Then midazolam 0.06 mg/kg was administered immediately ; 2 min after aforementioned treatments in each group , all patients received propofol 2 mg/kg ( propofol was mixed with lidocaine 1 mg/ml in Group C ) at an average rate of 0.2 ml per 1 s. Another anesthesiologist , blind to the pretreatment , recorded the occurrence of injection pain using a four-graded pain scale : 1 = no pain ( no reaction to injection ) , 2 = slight pain ( minor verbal/facial response or motor reaction to injection ) , 3 = moderate pain ( clear verbal/facial response or motor reaction to injection ) and 4 = severe pain ( the patient both complained of pain and withdrew the arm ) .
RESULTS	Forty ( 80 % ) patients in Group C ( control ) had injection pain ; however , none of patients in Group D had any injection pain .
RESULTS	The total incidence of profol-induced pain in Group C was significantly higher ( P < 0.01 ) .
RESULTS	There were no instances of bradycardia or low blood pressure with either treatment in this study .
CONCLUSIONS	Pretreatment with dexmedetomidine 0.6 g/kg , then midazolam 0.06 mg/kg could suppress propofol injection pain in children .

###24994869
OBJECTIVE	To compare the antioxidant and inflammatory cytokine activities in tears of patients with dry eye syndrome treated with preservative-free versus preserved eye drops .
METHODS	A total of 100 patients with moderate to severe dry eye syndrome were randomly divided into two groups .
METHODS	Fifty patients ( group 1 ) were treated four times with preservative-free 0.1 % sodium hyaluronate and 0.1 % fluorometholone eye drops in the first month and with preservative-free 0.1 % sodium hyaluronate and 0.05 % cyclosporine eye drops in the second and third months .
METHODS	Another 50 patients ( group 2 ) were treated with preserved eye drops on the same schedule .
METHODS	Ocular Surface Disease Index , corneal fluorescein staining , Schirmer I test , tear film breakup time , impression cytology , and antioxidant and inflammatory cytokine activities in tears were evaluated .
RESULTS	Treatment with preservative-free eye drops led to significant improvements in symptoms , tear film breakup time , Schirmer I score , and impression cytologic findings compared to treatment with preserved eye drops ( P < 0.05 ) in patients with dry eye syndrome .
RESULTS	There was a statistically significant decrease in the IL-1 , IL-6 , IL-12 , and TNF - concentrations and a statistically significant increase in the catalase , peroxiredoxin 2 , superoxide dismutase 2 ( SOD 2 ) , and thioredoxin mean fluorescence intensity ( MFI ) of tears in the preservative-free group at 1 , 2 , and 3 months compared to initial values , respectively ( P < 0.05 ) .
CONCLUSIONS	Treatment with preservative-free eye drops is effective against the dry eye syndrome .
CONCLUSIONS	Preservative-free eye drops seem to be more effective than preserved eye drops in decreasing ocular inflammation and in increasing antioxidant contents in tears of patients with dry eye syndrome .

###24461370
OBJECTIVE	The purpose of our study was to evaluate and compare two methods of service delivery ( web-based and telehealth-based ) for chronic insomnia with regard to patient preference , clinical effectiveness , and patient satisfaction .
METHODS	Our study was a randomized controlled trial with manualized telehealth - and web-based delivery conditions ( nonblinded ) .
METHODS	The sample comprised 73 adults with chronic insomnia .
METHODS	Participants received web-based delivery from their homes or telehealth-based delivery from a nearby clinic .
METHODS	Both interventions consisted of identical psychoeducation , sleep hygiene and stimulus control instruction , sleep restriction treatment , relaxation training , cognitive therapy , mindfulness meditation , and medication-tapering assistance .
RESULTS	Using a linear mixed model analysis , results showed that both delivery methods produced equivalent changes in insomnia severity , with large effect sizes .
RESULTS	Attendance patterns favored telehealth , whereas homework adherence and preference data favored web-based delivery .
CONCLUSIONS	Web - and telehealth-based delivery are both helpful in treating chronic insomnia in rural-dwelling adults .

###25879228
BACKGROUND	Metabolic syndrome ( MetS ) comprises a spectrum of clinical phenotypes in which dyslipidemia , dysglycemia and hypertension are clustered and where all share a high level of oxidative stress and an increased risk of cardiovascular disease .
BACKGROUND	This study examines the effect of a nutritional supplement combining red yeast rice and olive fruit extract on the lipid profile and on oxidative stress in a population of patients with MetS .
METHODS	In a double blind placebo controlled randomized trial , 50 persons with MetS , as defined by the ATPIII criteria , received the study product or placebo for 8 weeks .
METHODS	The study product contained 10.82 mg of monacolins and 9,32 mg of hydroxytyrosol per capsule , and is commercialized as Cholesfytol plus .
METHODS	The primary outcome measure was the difference in LDL reduction between intervention and control groups .
METHODS	Furthermore , differences in changes of CH , HDL , ApoA1 , ApoB , HbA1c and oxLDL were measured , as well as side-effects , CK elevation , changes in clinical parameters and in cardiovascular risk .
RESULTS	In the intervention group , LDL cholesterol was lowered by 24 % whereas it increased by 1 % in the control group ( p < 0.001 ) .
RESULTS	Other effects observed were a change in total cholesterol ( -17 % in the intervention group vs +2 % in the control group , p < 0.001 ) , apolipoprotein B ( -15 % vs +6 % , p < 0.001 ) , and TG ( -9 % vs + 16 % , p = 0.02 ) .
RESULTS	Oxidized LDL decreased by 20 % vs an increase of 5 % in the control group ( p < 0.001 ) .
RESULTS	Systolic and diastolic arterial blood pressure decreased significantly by 10 mmHg ( vs 0 % in the control group , p = 0.001 ) and 7 mmHg ( vs 0 % in the control group , p = 0.05 ) respectively .
RESULTS	One person in the intervention group , who suffered from Segawa 's syndrome , dropped out because of severe muscle ache .
CONCLUSIONS	The combination of active products in this study may be an alternative approach to statins in people who do not need , or can not or do not want to be treated with chemical statins .
CONCLUSIONS	Side effects , effects on oxidative stress and on glucose metabolism need to be examined more thoroughly .
BACKGROUND	Clinicaltrials.gov NCT02065180 ( February 2014 ) .

###24233282
BACKGROUND	Neurobehavioral functioning is widely recognized as being an important consideration in lung transplant candidates , but little is known about whether these factors are related to clinical outcomes .
BACKGROUND	The present study examined the relationship of neurobehavioral functioning , including measures of executive function and memory , depression , and anxiety , to long-term survival among lung transplant recipients .
METHODS	The sample was drawn from 201 patients who underwent transplantation at Duke University and Washington University who participated in a dual-site clinical trial investigating medical and psychosocial outcomes in transplant candidates with end-stage lung disease .
METHODS	All patients completed the Beck Depression Inventory-II ( BDI-II ) and Spielberger State-Trait Anxiety Inventory at baseline and again after 12 weeks , while a subset of 86 patients from Duke University also completed neurocognitive testing .
METHODS	Patients were followed for survival up to 12 years after completing baseline assessments .
RESULTS	One hundred eleven patients died over a mean follow-up of 10.8 years ( SD = 0.8 ) .
RESULTS	Baseline depression , anxiety , and neurocognitive function were examined as predictors of posttransplant survival , controlling for age , 6-min walk distance , FEV , and native disease ; education and cardiovascular risk factors were also included in the model for neurocognition .
RESULTS	Lower executive function ( hazard ratio [ HR ] = 1.09 , P = .012 ) and memory performance ( HR = 1.11 , P = .030 ) were independently associated with greater mortality following lung transplant .
RESULTS	Although pretransplant depression and anxiety were not predictive of mortality , patients who scored > 13 on the BDI-II at baseline and after 3 months pretransplant had greater mortality ( HR = 1.85 [ 95 % CI , 1.04 , 3.28 ] , P = .036 ) .
CONCLUSIONS	Neurobehavioral functioning , including persistently elevated depressive symptoms and lower neurocognitive performance , was associated with reduced survival after lung transplantation .
BACKGROUND	ClinicalTrials.gov ; No. : NCT00113139 ; URL : www.clinicaltrials.gov .

###25482548
OBJECTIVE	To compare measures of dry mouth following extended use of an alcohol-based mouthrinse ( LISTERINE Antiseptic [ LA ] ) and a non-alcohol-based mouthrinse ( Crest Pro-Health Rinse [ CPH ] ) on healthy adults with `` normal '' salivary flow .
METHODS	This single-site , randomized , observer-blinded , parallel study compared unstimulated whole salivary flow and perceived dryness following daily use at weeks 4 and 12 versus baseline .
METHODS	Noninferiority , between-treatment flow comparisons ( 0.15 mL/min margin ) , and between-treatment comparisons of the mean Bluestone Mouthfeel Questionnaire ( BMQ ) visual analog scale scores were made using analysis of covariance .
RESULTS	Measures of dry mouth were comparable between mouthrinses , as demonstrated by both noninferiority of LA versus CPH flow ( P < .001 ) and no significant differences between groups in the BMQ measures at 4 or 12weeks .
CONCLUSIONS	Extended use of an alcohol-based mouthrinse is no more likely to cause reduction in salivary flow or perceived dryness in individuals with normal salivary flow compared with a non-alcohol-based mouthrinse ( CPH ) .

###24281785
OBJECTIVE	To investigate the relationship between optic nerve sheath diameter ( ONSD ) and retrobulbar blood flow velocities , as measured by color Doppler imaging ( CDI ) in glaucoma patients .
METHODS	We performed a prospective , randomized , observer-masked study involving a total of 197 subjects .
METHODS	Once enrolled , they were divided by three groups : healthy controls ( n = 51 ) , normal-tension glaucoma patients ( NTG , n = 58 ) , and primary , open-angle glaucoma patients ( POAG , n = 88 ) .
METHODS	All subjects underwent a general ophthalmological examination , an ultrasound-based assessment of the ONSD , and a hemodynamic study of the retrobulbar vascularization using CDI .
METHODS	Non-parametric tests , chi-square contingency tables , and the Deming correlations were used to explore differences and correlations between variables in the diagnostic groups .
RESULTS	ONSD was not different between experimental groups ( p = 0.28 ) .
RESULTS	ONSD correlated positively with the pulsatility index of the ophthalmic artery in healthy individuals ( p = 0.007 ) , but not in glaucoma patients ( NTG : p = 0.41 ; POAG : p = 0.22 ) .
RESULTS	In NTG patients , higher ONSD values were associated with lower end-diastolic and mean flow velocities in the short ciliary arteries ( p = 0.005 in both correlations ) .
RESULTS	No such correlation was found in healthy nor POAG groups ( p range between 0.15 to 0.96 ) .
RESULTS	ONSD was not associated with any CDI-related variable of the central retinal artery in any cohort .
RESULTS	Venous outflow velocities were not associated with ONSD in any of the three groups .
CONCLUSIONS	ONSD is negatively correlated with retrobulbar blood flow velocities in glaucoma patients , but not in healthy controls .

###24400920
OBJECTIVE	The objective of this study was to compare the efficacy and safety of dexamethasone and methylprednisolone for pulse therapy of rheumatoid arthritis flare-up .
METHODS	This randomized double-blind controlled study was performed in the Emam Reza Educational Hospital of Tabriz University of Medical Sciences , Tabriz , Iran .
METHODS	Thirty rheumatoid arthritis patients who had severely active disease were recruited to the dexamethasone and methylprednisolone pulse groups .
METHODS	Disease activity of all the patients was measured by the Disease Activity Score in 28 joints ( DAS28 ) at baseline , and days 4 and 30 .
RESULTS	The differences in the DAS28 at days 4 and 30 , and the number of patients whose DAS28 obtained less than 3.2 and 2.6 in the dexamethasone and methylprednisolone groups were non-significant .
RESULTS	There was not any significant difference between the adverse effects of the treatments in the two groups .
CONCLUSIONS	The results of the study suggest that dexamethasone pulse therapy is a safe and effective treatment for severe rheumatoid arthritis flare-up .

###25389284
BACKGROUND	Both supervised exercise ( SE ) and stenting ( ST ) improve functional status , symptoms , and quality of life compared with optimal medical care ( OMC ) in patients with claudication .
BACKGROUND	The relative cost-effectiveness of these strategies is not well defined .
RESULTS	The Claudication : Exercise Versus Endoluminal Revascularization ( CLEVER ) study randomized patients with claudication due to aortoiliac stenosis to a 6-month SE program , to ST , or to OMC .
RESULTS	Participants who completed 6-month follow-up ( n = 98 ) were included in a health economic analysis through 18 months .
RESULTS	Costs were assessed using resource-based methods and hospital billing data .
RESULTS	Quality-adjusted life-years were estimated using the EQ-5D .
RESULTS	Markov modeling based on the in-trial results was used to explore the impact of assumptions about the longer term durability of observed differences in quality of life .
RESULTS	Through 18 months , mean healthcare costs were $ 5178 , $ 9804 , and $ 14 590 per patient for OMC , SE , and ST , respectively .
RESULTS	Measured quality-adjusted life-years through 18 months were 1.04 , 1.16 , and 1.20 .
RESULTS	In our base case analysis , which assumed that observed differences in quality of life would dissipate after 5 years , the incremental cost-effectiveness ratios were $ 24 070 per quality-adjusted life-year gained for SE versus OMC , $ 41 376 for ST versus OMC , and $ 122 600 for ST versus SE .
RESULTS	If the treatment effect of ST was assumed to be more durable than that of SE , the incremental cost-effectiveness ratio for ST versus SE became more favorable .
CONCLUSIONS	Both SE and ST are economically attractive by US standards relative to OMC for the treatment of claudication in patients with aortoiliac disease .
CONCLUSIONS	ST is more expensive than SE , with uncertain incremental benefit .
BACKGROUND	www.clinicaltrials.gov , Unique identifier : NCT00132743 .

###24665869
BACKGROUND	Vitiligo can be associated with high levels of distress , yet there are currently no self-help interventions available .
OBJECTIVE	To describe the initial development of a psychosocial self-help intervention designed to reduce social anxiety associated with vitiligo .
OBJECTIVE	Also to examine whether including a planning exercise , aimed at increasing use of the intervention ( termed implementation intentions ) , has the potential to achieve a clinically significant reduction in distress .
METHODS	Participants ( n = 75 ) were randomized to one of three groups : cognitive behavioural self-help ( CBSH ) , CBSH augmented with implementation intentions ( CBSH + ) , or no intervention .
METHODS	Participants were assessed at baseline and after 8weeks on measures of social anxiety , anxiety and depression , and appearance-related concern .
METHODS	The two intervention groups also completed a questionnaire evaluating their use of , and satisfaction with , the intervention .
RESULTS	High levels of social anxiety and concern over appearance were reported .
RESULTS	Twenty-four per cent of participants in the CBSH + group experienced clinically significant change on the measure of social anxiety compared with 8 % in the CBSH group and 0 % in the control group .
RESULTS	In addition , 58 % of the control group deteriorated during the study period .
RESULTS	There were no significant differences between the conditions on the other outcome measures .
RESULTS	Participants reported that the self-help leaflets were helpful .
CONCLUSIONS	The findings demonstrate that augmented CBSH provides a relatively simple and accessible intervention that can result in a clinically significant reduction in social anxiety .
CONCLUSIONS	The augmented intervention has potential and might be further developed and evaluated in subsequent trials .

###25242048
BACKGROUND	In the final analysis of the phase 3 COU-AA-301 study , abiraterone acetate plus prednisone significantly prolonged overall survival compared with prednisone alone in patients with metastatic castration-resistant prostate cancer progressing after chemotherapy .
BACKGROUND	Here , we present the final analysis of an early-access protocol trial that was initiated after completion of COU-AA-301 to enable worldwide preapproval access to abiraterone acetate in patients with metastatic castration-resistant prostate cancer progressing after chemotherapy .
METHODS	We did a multicentre , open-label , early-access protocol trial in 23 countries .
METHODS	We enrolled patients who had metastatic castration-resistant prostate cancer progressing after taxane chemotherapy .
METHODS	Participants received oral doses of abiraterone acetate ( 1000 mg daily ) and prednisone ( 5 mg twice a day ) in 28-day cycles until disease progression , development of sustained side-effects , or abiraterone acetate becoming available in the respective country .
METHODS	The primary outcome was the number of adverse events arising during study treatment and within 30 days of discontinuation .
METHODS	Efficacy measures ( time to prostate-specific antigen [ PSA ] progression and time to clinical progression ) were gathered to guide treatment decisions .
METHODS	We included in our analysis all patients who received at least one dose of abiraterone acetate .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01217697 .
RESULTS	Between Nov 17 , 2010 , and Sept 30 , 2013 , 2314 patients were enrolled into the early-access protocol trial .
RESULTS	Median follow-up was 57 months ( IQR 35-106 ) .
RESULTS	952 ( 41 % ) patients had a grade 3 or 4 treatment-related adverse event , and grade 3 or 4 serious adverse events were recorded in 585 ( 25 % ) people .
RESULTS	The most common grade 3 and 4 adverse events were hepatotoxicity ( 188 [ 8 % ] ) , hypertension ( 99 [ 4 % ] ) , cardiac disorders ( 52 [ 2 % ] ) , osteoporosis ( 31 [ 1 % ] ) , hypokalaemia ( 28 [ 1 % ] ) , and fluid retention or oedema ( 23 [ 1 % ] ) .
RESULTS	172 ( 7 % ) patients discontinued the study because of adverse events ( 64 [ 3 % ] were drug-related ) , as assessed by the investigator , and 171 ( 7 % ) people died .
RESULTS	The funder assessed causes of death , which were due to disease progression ( 85 [ 4 % ] ) , an unrelated adverse experience ( 72 [ 3 % ] ) , and unknown reasons ( 14 [ 1 % ] ) .
RESULTS	Of the 86 deaths not attributable to disease progression , 18 ( < 1 % ) were caused by a drug-related adverse event , as assessed by the investigator .
RESULTS	Median time to PSA progression was 85 months ( 95 % CI 83-97 ) and median time to clinical progression was 127 months ( 118-138 ) .
CONCLUSIONS	No new safety signals or unexpected adverse events were found in this early-access protocol trial to assess abiraterone acetate for patients with metastatic castration-resistant prostate cancer who progressed after chemotherapy .
CONCLUSIONS	Future work is needed to ascertain the most effective regimen of abiraterone acetate to optimise patients ' outcomes .
BACKGROUND	Janssen Research & Development .

###24497220
OBJECTIVE	In the last years there has been a progressive reduction of the average duration of sleep and an increase in the incidence of sleep disturbances .
OBJECTIVE	At the same time , an increase of the incidence of the metabolic syndrome has been described , partly attributable to the progressive worsening of dietary habits and the increase in sedentary lifestyle .
OBJECTIVE	Recent studies suggest that adequate sleep is essential to maintain good glucose metabolism and sleep disturbances may contribute to the manifestation of the metabolic syndrome .
OBJECTIVE	Benzodiazepines ( BZ ) , such as brotizolam , and imidazopyridines , such as zolpidem , are frequently used as hypnotics but their potential impact on glucose metabolism has never been evaluated so far .
METHODS	In 12 healthy volunteers [ age ( mean SEM ) 38.3 8.1 years ; body mass index ( BMI ) 21.9 0.8 kg/m ] we studied glucose and insulin responses to oral glucose tolerance test ( OGTT , 75 g ) before and after 15 days treatment with brotizolam 0.25 mg/day or zolpidem 10 mg/day .
RESULTS	Brotizolam increased glucose delta area under curve response to the OGTT by 122 % ( p < 0.01 ) and zolpidem by 86 % ( p < 0.01 ) without significant variations of insulin levels , suggesting an impact on insulin sensitivity and/or insulin secretion .
CONCLUSIONS	This study suggests that BZ and imidazopyridines have a rapid glucometabolic effect that is detectable as early as after 15 days treatment .

###26390700
OBJECTIVE	To compare the therapeutic and side effects of using Californium252 ( 252Cf ) neutron brachytherapy with neoadjuvant intra-arterial embolism chemotherapy in combination with surgery for treating Stage Ib2-IIb cervical cancers ( CCs ) .
METHODS	Thirty-two Stage Ib2-IIb CC patients were enrolled and randomly divided into two groups from January 2007 to April 2010 in the present Hospital .
METHODS	Prior to surgery within four weeks , a total of 17 cases were treated with 252Cf neutron brachytherapy ( 700-800 cGy doses at point A ) once a week ( Group A ) , and 15 cases were treated by neoadjuvant intra-arterial embolism chemotherapy using a combination of bleomycin , carboplatin , and cyclophosphamide twice ( Group B ) .
METHODS	The clinical symptoms and signs , side effects , and relapse condition follow up until July 2013 were compared between the two groups for the perioperation .
RESULTS	Reductions in tumor mass and CR+PR were not significantly different between the groups before the surgery ( p > 0.05 ) .
RESULTS	Abdominal pain and pelvic adhesions were significantly more severe in Group B ( p < 0.05 ) .
RESULTS	There were no significant differences in surgical time , blood loss or the other side effects between Groups A and B ( p > 0.05 ) .
RESULTS	The percentage of pelvic tumor recurrences in Group A was lower than that of the patients in Group B ( 11.8 % vs 20.0 % ) although with no significant difference at present .
RESULTS	No distant metastasis has been found in both two groups .
CONCLUSIONS	Except for less abdominal pain and pelvic adhesions , 252Cf neutron brachytherapy has perioperative effects similar to those of neoadjuvant intra-arterial embolism chemotherapy .

###25442992
BACKGROUND	New-onset postoperative atrial fibrillation ( POAF ) after coronary artery bypass graft surgery ( CABG ) is associated with worse in-hospital morbidity and mortality , extended hospital stays , and higher costs .
BACKGROUND	Beyond the initial hospital discharge , the cost and outcomes of POAF have not been well studied .
METHODS	For CABG patients with and without new-onset POAF , a retrospective propensity-matched , multivariable regression analysis was performed to compare 1-year outcomes ( including health-related quality of life [ HRQoL ] scores and mortality rates ) and costs ( standardized to 2010 dollars ) .
METHODS	Regression models controlled for site and patient factors , with propensity matching used to adjust for differences in POAF versus no-POAF patients ' risk profiles .
RESULTS	Using the existing CABG trial database , 2,096 patient records were analyzed , including POAF patients ( n = 549 ) versus no-POAF patients ( n = 1,547 ) .
RESULTS	For the index CABG hospitalization , POAF patients had longer postoperative length of stay ( +3.9 days ) and higher discharge costs ( + $ 13,993 ) than no-POAF patients .
RESULTS	At 1 year , POAF patients had more than twice the adjusted odds of dying ( p < 0.01 ) , with higher 1-year total cumulative costs .
RESULTS	This 1-year cost difference ( + $ 15,593 ) was largely attributable to hospital-based costs during the index surgery hospitalization .
RESULTS	There was no difference in 1-year HRQoL scores ( or HRQoL score changes ) between POAF patients and no-POAF patients .
CONCLUSIONS	Compared with no-POAF patients , POAF patients had higher discharge and 1-year costs along with higher 1-year mortality rates , but no differences were observed in 1-year HRQoL scores .
CONCLUSIONS	Additional research appears warranted to improve the longer-term survival rates for POAF CABG patients , targeting future POAF-specific postdischarge interventions .

###25773149
BACKGROUND	Deficiency of vitamin D is an environmental risk factor for MS. Vitamin D has immunomodulatory effects , including promotion of T-cell differentiation into T-regulatory cells , which produces regulatory cytokines including TGF - .
BACKGROUND	Increasing serum vitamin D levels have been associated with decreased disease activity in MS patients , but there are only few studies concerning the immunological effects of vitamin D supplementation in MS. In this study we investigated the effect of weekly supplementation of vitamin D3 or placebo on serum levels of multiple cytokines in patients with relapsing remitting MS.
METHODS	The study was conducted on the patient cohort of the Finnish Vitamin D study .
METHODS	All patients were using IFN-beta-1b and were randomized to add-on treatment with either cholecalciferol 20,000 IU/week or placebo .
METHODS	Concentrations of LAP ( TGF - ) , INF - , IL-17A , IL-2 , IL-10 , IL-9 , IL-22 , IL-6 , IL-13 , IL-4 , IL-5 , IL-1 and TNF - were determined at screening and at 12 months using commercial fluorescent bead immunoassay kits .
RESULTS	LAP ( TGF - ) levels increased significantly in the vitamin D treated group from a mean of 47 ( SE 11 ) pg/ml to 55 ( SE 14 ) pg/ml in 12 months ( p-value = 0.0249 ) .
RESULTS	Placebo treatment had no significant effect on LAP levels .
RESULTS	The levels of the other cytokines did not change significantly in either group .
CONCLUSIONS	We showed increased serum latency activated peptide ( LAP ) of TGF - levels in MS patients treated with vitamin D3 .
CONCLUSIONS	The immune regulatory effects of TGF-beta may play a role in the improved MRI outcomes that we observed earlier in the vitamin D treated group of patients .

###24612899
BACKGROUND	Many patients with suspected non-ST-segment elevation acute coronary syndrome ( NSTE-ACS ) do not have significant coronary artery disease .
BACKGROUND	The current diagnostic approach of repeated electrocardiography and cardiac biomarker assessment requires observation for > 6 to 12 hours .
BACKGROUND	This strategy places a heavy burden on hospital facilities .
BACKGROUND	The objective of this study was to investigate whether myocardial strain assessment by echocardiography could exclude significant coronary artery stenosis in patients presenting with suspected NSTE-ACS .
METHODS	Sixty-four patients presenting to the emergency department with suspected NSTE-ACS without known coronary artery disease , inconclusive electrocardiographic findings , and normal cardiac biomarkers at arrival were enrolled .
METHODS	Twelve-lead electrocardiography , troponin T assay , and echocardiography were performed at arrival , and all patients underwent coronary angiography .
METHODS	Significant coronary stenosis was defined as > 50 % luminal narrowing .
METHODS	Global myocardial peak systolic longitudinal strain was measured using speckle-tracking echocardiography .
METHODS	Left ventricular ejection fraction and wall motion score index were calculated .
RESULTS	No significant stenosis in any coronary artery was found in 35 patients ( 55 % ) .
RESULTS	Global peak systolic longitudinal strain was superior to conventional echocardiographic parameters in distinguishing patients with and without significant coronary artery stenosis ( area under the curve , 0.87 ) .
RESULTS	Sensitivity and specificity were calculated as 0.93 and 0.78 , respectively , and positive predictive value and negative predictive value as 0.74 and 0.92 , respectively .
RESULTS	Feasibility of the strain measurements was excellent , with 97 % of segments analyzed .
CONCLUSIONS	Myocardial strain by echocardiography may facilitate the exclusion of significant coronary artery stenosis among patients presenting with suspected NSTE-ACS with inconclusive electrocardiographic findings and normal cardiac biomarkers .

###25938655
OBJECTIVE	Evidence-based treatments that achieve optimal energy intake and improve growth in preschool-aged children with cystic fibrosis ( CF ) are a critical need .
OBJECTIVE	To test whether behavioral and nutritional treatment ( intervention ) was superior to an education and attention control treatment in increasing energy intake , weight z ( WAZ ) score , and height z ( HAZ ) score .
METHODS	This randomized clinical trial included 78 children aged 2 to 6 years ( mean age , 3.8 years ) with CF and pancreatic insufficiency ( intervention , n = 36 and control , n = 42 ) .
METHODS	The study was conducted at 7 CF centers between January 2006 and November 2012 ; all 78 participants who met intent-to-treat criteria completed through follow-up .
METHODS	Behavioral intervention combined individualized nutritional counseling targeting increased energy intake and training in behavioral child management skills .
METHODS	The control arm provided education and served as a behavioral placebo controlling for attention and contact frequency .
METHODS	Both treatments were delivered in person or telehealth ( via telephone ) .
METHODS	Sessions occurred weekly for 8 weeks then monthly for 4 months ( 6 months ) .
METHODS	Participants then returned to standard care for 1 year , with 12-month follow-up thereafter .
METHODS	Changes in energy intake and WAZ score were examined from pretreatment to posttreatment ( 6 months ) and change in HAZ score was assessed pretreatment to follow-up ( 18 months ) .
METHODS	Covariates included sex , Pseudomonas aeruginosa status at baseline , and treatment modality ( in person vs telehealth ) .
RESULTS	At baseline , mean ( SD ) energy intake was 1462 ( 329 ) kcals/d , WAZ score was -0.44 ( 0.81 ) , and HAZ score was -0.55 ( 0.84 ) .
RESULTS	From pretreatment to posttreatment , the intervention increased daily energy intake by 485 calories vs 58 calories for the control group ( adjusted difference , 431 calories ; 95 % CI , 282 to 581 ; P < .001 ) and increased the WAZ score by 0.12 units vs 0.06 for the control ( adjusted difference , 0.09 ; 95 % CI , -0.06 to 0.24 ; P = .25 ) .
RESULTS	From pretreatment to follow-up , the intervention increased the HAZ score by 0.09 units vs -0.02 for the control ( adjusted difference , 0.14 units ; 95 % CI , 0.001 to 0.27 ; P = .049 ) .
RESULTS	Measured treatment integrity and credibility were high for both groups .
CONCLUSIONS	Behavioral and nutritional intervention improved energy intake and HAZ score outcomes but not WAZ score outcomes .
CONCLUSIONS	Our results provide evidence that behavioral and nutritional treatment may be efficacious as a nutritional intervention for preschoolers aged 2 to 6 years with CF and pancreatic insufficiency .
BACKGROUND	clinicaltrials.gov Identifier : NCT00241969 .

###25620454
OBJECTIVE	This study describes the lifetime prevalence of teen dating violence ( TDV ) perpetration in a sample of middle school students from high-risk urban communities and examines the relation between TDV and related cognitive and behavioral risk factors .
METHODS	Surveys were administered to 2,895 middle school students in four U.S. cities ; 1,673 students ( 58 % ) reported having dated and were included in analyses .
METHODS	The sample was 52.3 % female , 48.2 % non-Hispanic black/African-American , 38.2 % Hispanic , 4.8 % non-Hispanic white , and 7.6 % other race .
METHODS	Six types of TDV perpetration were assessed : threatening behaviors , verbal/emotional abuse , relational abuse , physical abuse , sexual abuse , and stalking .
RESULTS	Of the students who had dated , 77 % reported perpetrating verbal/emotional abuse , 32 % reported perpetrating physical abuse , 20 % reported threatening a partner , 15 % reported perpetrating sexual abuse , 13 % reported perpetrating relational abuse , and 6 % reported stalking .
RESULTS	Girls were more likely than boys to report perpetrating threatening behaviors , verbal/emotional abuse , and physical abuse , and boys were more likely to report perpetrating sexual abuse .
RESULTS	Involvement in bullying positively predicted perpetration of TDV , albeit , in different ways for boys and girls .
RESULTS	Other risk factors differed by sex .
RESULTS	For instance , alcohol use and sex initiation predicted multiple forms of TDV perpetration for boys , whereas weapon carrying and emotional symptoms predicted several forms of TDV perpetration for girls .
CONCLUSIONS	The prevalence of TDV was high in our sample .
CONCLUSIONS	Important sex differences in rates of perpetration and risk factors emerged .
CONCLUSIONS	Comprehensive prevention programs that target TDV and related risk factors , such as bullying and other risk factors , seem warranted .

###25204091
OBJECTIVE	The aim of the research was to indicate whether there are differences between locus of control ( LOC ) in girls with anorexia readiness syndrome ( ARS ) and without this syndrome .
OBJECTIVE	There was also a question about the relationship between LOC and the tendency to respond in incorrect attitudes towards food , eating and their bodies under stress .
METHODS	The sample consisted of girls aged 13-18 years randomly selected from five public Polish middle and high schools .
METHODS	Tools : 1 ) Eating Attitudes Questionnaire ( EAQ ) by B. Zikowska ; 2 ) Locus of Control Questionnaire ( LOCQ ) by G. Krasowicz , A. Kurzyp-Wojnarska , to assess LOC of the subjects .
METHODS	The criterion group ( N = 23 ) was formed by girls who received high score in EAQ ( signs of ARS ) in the first stage of research ( N = 189 ) .
METHODS	The control group ( N = 23 ) were girls who received a low score in EAQ ( no signs of ARS ) .
RESULTS	Subjects with ARS were characterized by more external LOC than girls without any signs of this syndrome ( t = -2.898 ; p < 0.01 ) .
RESULTS	The results did not confirm the hypothesis about the relationship between LOC and the tendency to respond by abnormal attitude to eating and own body in difficult situations in both groups .
CONCLUSIONS	In pathogenesis of ARS where anorexic behaviors can become a way to a regain lost control , LOC may play a role as a mediating variable rather than a direct determinant of this syndrome .

###24463451
BACKGROUND	Adults with osteogenesis imperfecta ( OI ) have a high risk of fracture .
BACKGROUND	Currently , few treatment options are available , and bone anabolic therapies have not been tested in clinical trials for OI treatment .
METHODS	79 adults with OI were randomized to receive 20 g recombinant human parathyroid hormone ( teriparatide ) or placebo for 18 months in a double-blind , placebo-controlled trial .
METHODS	The primary endpoint was the percent change in areal bone mineral density ( aBMD ) of the lumbar spine ( LS ) , as determined by dual-energy X-ray absorptiometry .
METHODS	Secondary endpoints included percent change in bone remodeling markers and vertebral volumetric BMD ( vBMD ) by quantitative computed tomography , estimated vertebral strength by finite element analysis , and self-reported fractures .
RESULTS	Compared with the placebo group , the teriparatide group showed increased LS aBMD ( 6.1 % 1.0 % vs. 2.8 % 1.0 % change from baseline ; P < 0.05 ) and total hip aBMD ( 2.6 % 1.0 % vs. -2.4 % 1.0 % change ; P < 0.001 ) .
RESULTS	Vertebral vBMD and strength improved with teriparatide therapy ( 18 % 6 % and 15 % 3 % change , respectively ) , but declined with placebo ( -5.0 % 6 % and -2.0 % 3 % change ; P < 0.05 for both comparisons ) .
RESULTS	Serum procollagen type 1 N-terminal propeptide ( P1NP ) and urine collagen N-telopeptide ( NTx ) levels increased with teriparatide therapy ( 135 % 14 % and 64 % 10 % change , respectively ) .
RESULTS	Teriparatide-induced elevation of P1NP levels was less pronounced in severe forms of OI ( type III/IV ) compared with the milder form ( type I ) .
RESULTS	Type I OI patients exhibited robust BMD increases with teriparatide ; however , there was no observed benefit for those with type III/IV OI .
RESULTS	There was no difference in self-reported fractures between the 2 groups .
CONCLUSIONS	Adults with OI , particularly those with less severe disease ( type I ) , displayed a teriparatide-induced anabolic response , as well as increased hip and spine aBMD , vertebral vBMD , and estimated vertebral strength .
CONCLUSIONS	Trial registration .
CONCLUSIONS	Clinicaltrials.gov NCT00131469 .
CONCLUSIONS	Funding .
CONCLUSIONS	The Osteoporosis Imperfecta Foundation , Eli Lilly and Co. , the National Center for Advancing Translational Science ( NCATS ) at the NIH ( grant no .
CONCLUSIONS	UL1RR024140 ) , and the Baylor College of Medicine General Clinical Research Center ( grant no .
CONCLUSIONS	RR00188 ) .

###25306677
OBJECTIVE	To evaluate the effects of remote ischemic preconditioning ( RIPC ) on the perioperative period in elective aortic valve replacement ( AVR ) along different anaesthesia techniques .
METHODS	48 patients aged 50 to 75 years ( 64 ( 56 ; 69 ) ) which were scheduled for AVR due to aortic valve stenosis were included into the prospective , randomized study .
METHODS	Four groups were formed after randomization : 1 ) RIPC applied during propofol anesthesia ( RIPCprop , n = 12 ) , 2 ) RIPC applied during sevoflurane anesthesia ( RIPCsevo , n = 12 ) , 3 ) propofol anesthesia without RIPC ( CONTROLprop , n = 12 ) , 4 ) sevoflurane anesthesia without RIPC ( CONTROLsevo , n = 12 ) .
METHODS	Groups were similar in baseline data of patients .
METHODS	RIPC protocol : three five-minutes episodes of simultaneous both lower limbs ischemia with five-minutes reperfusion intervals .
METHODS	Troponin I ( cTrI ) , interleukin-6 ( IL-6 ) , Interleukin-8 ( IL-8 ) and C-reactive protein ( CRP ) levels were assessed prior to induction of anesthesia , at 30 min , 6 , 12 , 24 and 48 hours after the cessation of CPB .
METHODS	Significant differences were assessed by the nonparametric Mann-Whitney and Fisher 's exact tests .
METHODS	Data are presented as : median ( 25th percentile , 75th percentile ) .
RESULTS	Significant differences in cTnI were found between RIPCsevo and CONTROLsevo groups at 6 , 12 and 24 hours : 1.68 ( 1.28 , 2.09 ) ng/ml vs 3.66 ( 2.07 , 4.49 ) ng/ml , respectively at 6 hours ( p = 0.04 ) ; 1.89 ( 1.59 , 2.36 ) ng/ml vs 3.66 ( 2.91 , 5.64 ) ng/ml , respectively at 12 hours ( p = 0.001 ) ; 1.68 ( 1.55 ; 2.23 ) ng/ml vs 3.32 ( 2.10 ; 5.46 ) ng/ml , respectively at 24 hours ( p = 0.01 ) .
RESULTS	There were no differences found in cTnI between RIPCprop and CONTROLprop groups during the whole study .
RESULTS	There were no significant differences found in the levels of IL-6 and CRP between RIPC and control groups during the whole study Unexpectedly significant excess concentrations of IL-8 at 24 h were found when RIPC applied during sevoflurane anesthesia : 12.3 ( 10.6 , 14.4 ) pg/mL in RIPCsevo group vs 6.2 ( 4.8 , 11.1 ) pg/ml in CONTROLsevo group ( p = 0.02 ) .
RESULTS	There was no paroxysmal atrial fibrillation ( AF ) after RIPC , and 5 cases were registered in the control groups ( p = 0.02 ) .
RESULTS	No other significant differences in the clinical course of the postoperative period were found .
CONCLUSIONS	Cardioprotective effect of RIPC and its effect on systemic inflammatory response should be assessed in the selected anesthesia groups .
CONCLUSIONS	RIPC on the background of sevoflurane anesthesia reduces myocardial injury during AVR .
CONCLUSIONS	RIPC does not reduce the severity of the systemic inflammatory response after AVR .
CONCLUSIONS	RIPC reduces the risk of AF after AVR .

###24581948
OBJECTIVE	The purpose of this study is to investigate potential associations between sympathoadrenal activation and/or vasopressor/inotropic therapy and endothelial activation , damage , and coagulopathy in septic patients .
METHODS	Septic patients included in the Scandinavian Starch for Severe Sepsis/Septic Shock trial who were expected not to receive catecholamines at screening preintervention ( baseline ) and had baseline blood sampled .
METHODS	Clinical , outcome data , and measurements of plasma concentration ( p - ) biomarkers reflecting sympathoadrenal activation , endothelial activation and damage , natural anticoagulation , fibrinolysis , cell damage , and platelet activation .
RESULTS	Sixty-seven patients were included , of whom 14 turned out to receive noradrenaline infusion at blood sampling .
RESULTS	These 14 patients had p-noradrenaline 5-fold higher than patients not receiving catecholamines ( n = 53 ) , whereas no other baseline preintervention biomarkers differed .
RESULTS	In the 53 patients not receiving catecholamines at blood sampling , endogenous p-noradrenaline correlated positively with adrenaline , syndecan 1 , soluble vascular endothelial growth factor receptor 1 , soluble CD40 ligand , tissue-type plasminogen activator , and plasminogen activator inhibitor 1 ( PAI-1 ) and negatively with PAI-1 / tissue-type plasminogen activator ratio ( all P < .05 ) and was independently associated with syndecan 1 , soluble vascular endothelial growth factor receptor 1 , and PAI-1 ( all P < .05 ) , and 28 - and 90-day mortality ( P < .05 ) .
CONCLUSIONS	In septic patients , endogenous noradrenaline was independently associated with biomarkers of endothelial activation , damage , fibrinolysis and mortality , comparable with findings in trauma and myocardial infarction patients .
CONCLUSIONS	The catecholamine surge in critical illness may contribute to balance endothelial damage and procoagulation with hypocoagulability and hyperfibrinolysis in the circulating blood .

###24613294
OBJECTIVE	The objective was to determine the effects of omega-3 supplementation on nutritional state and inflammatory markers of hemodialysis patients .
METHODS	This was a randomized , placebo-controlled trial .
METHODS	Adult patients undergoing maintenance hemodialysis were included .
METHODS	Patients with malignancy , pregnancy , concurrent inflammatory or infectious diseases , or concomitant use of any medication affecting inflammation status were excluded .
METHODS	The omega-3 group received 6 soft-gel capsules of fish oil ( 180mg eicosapentaenoic acid and 120mg docosahexaenoic acid in each ) daily for 4months , and the placebo group received corresponding paraffin oil capsules.Nutrition indices including body mass index ; mid-arm muscle circumference ; serum concentrations of albumin , prealbumin , and transferrin ; and serum levels of inflammatory/anti-inflammatory markers including interleukin ( IL ) -6 , IL-10 , tumor necrosis factor ( TNF ) - , C-reactive protein , ferritin , parathyroid hormone , and ratios of IL-10 to TNF - and IL-10 to IL-6 were measured before and after 4months of intervention .
RESULTS	Twenty patients in the placebo and 25 patients in the omega-3 group completed the study .
RESULTS	There were no significant changes in nutritional markers between the omega-3 and placebo groups after 4months of intervention .
RESULTS	Regression analysis adjusting post-treatment values of nutrition markers for baseline values , omega-3 treatment , and patients ' baseline demographic and clinical data revealed that omega-3 treatment was a significant independent predictor of increased serum prealbumin level ( 182.53 ; 95 % confidence interval 21.14 , 511.18 ; P = .11 ) .
RESULTS	Although slight reduction of inflammatory state was observed in the omega-3 group , no significant differences were evident in the mean changes of inflammatory and anti-inflammatory markers between the 2 groups with the exception of serum ferritin level and the IL-10 to IL-6 ratio , which significantly changed in favor of omega-3 supplementation ( P < .001 and P = .003 , respectively ) .
CONCLUSIONS	Omega-3 supplementation in hemodialysis patients produced a slight attenuation in systemic inflammation without any remarkable effects on nutritional markers .

###24849794
OBJECTIVE	To improve gait and balance in patients with Parkinson 's disease by combining anodal transcranial direct current stimulation with physical training .
METHODS	In a double-blind design , one group ( physical training ; n = 8 ) underwent gait and balance training during transcranial direct current stimulation ( tDCS ; real/sham ) .
METHODS	Real stimulation consisted of 15 minutes of 2 mA transcranial direct current stimulation over primary motor and premotor cortex .
METHODS	For sham , the current was switched off after 30 seconds .
METHODS	Patients received the opposite stimulation ( sham/real ) with physical training one week later ; the second group ( No physical training ; n = 8 ) received stimulation ( real/sham ) but no training , and also repeated a sequential transcranial direct current stimulation session one week later ( sham/real ) .
METHODS	Hospital Srio Libanes , Buenos Aires , Argentina .
METHODS	Sixteen community-dwelling patients with Parkinson 's disease .
METHODS	Transcranial direct current stimulation with and without concomitant physical training .
METHODS	Gait velocity ( primary gait outcome ) , stride length , timed 6-minute walk test , Timed Up and Go Test ( secondary outcomes ) , and performance on the pull test ( primary balance outcome ) .
RESULTS	Transcranial direct current stimulation with physical training increased gait velocity ( mean = 29.5 % , SD = 13 ; p < 0.01 ) and improved balance ( pull test : mean = 50.9 % , SD = 37 ; p = 0.01 ) compared with transcranial direct current stimulation alone .
RESULTS	There was no isolated benefit of transcranial direct current stimulation alone .
RESULTS	Although physical training improved gait velocity ( mean = 15.5 % , SD = 12.3 ; p = 0.03 ) , these effects were comparatively less than with combined tDCS + physical therapy ( p < 0.025 ) .
RESULTS	Greater stimulation-related improvements were seen in patients with more advanced disease .
CONCLUSIONS	Anodal transcranial direct current stimulation during physical training improves gait and balance in patients with Parkinson 's disease .
CONCLUSIONS	Power calculations revealed that 14 patients per treatment arm ( = 0.05 ; power = 0.8 ) are required for a definitive trial .

###24435207
OBJECTIVE	The purpose of the study is to investigate the efficacy of an alpha-1 adrenergic receptor antagonist ( silodosin ) for the treatment of lower urinary tract symptoms ( LUTS ) associated with interstitial ( 125 ) I implantation for prostate cancer .
METHODS	This randomized single-center study involved 105 patients ( 53 with and 52 without silodosin ) .
METHODS	Silodosin was postoperatively administered , daily , for 6 months ( 8 mg/day ) .
METHODS	Urinary symptoms and pressure flow were evaluated preoperatively and postoperatively at 1 , 3 , 6 , and 12 months .
RESULTS	At 12 months , interstitial ( 125 ) I implantation had induced a significant decrease in prostate volume ( 28.3 11.1-20 .5 8.1 g in the silodosin group and 26.1 9.7-17 .7 4.9 g in the controls ) and the prostate-specific antigen level ( 7.1 3.6-1 .4 1.7 ng/mL in the silodosin group and 8.1 4.3-1 .3 1.2 ng/mL in the controls ) .
RESULTS	Significant improvements in the international prostate symptom voiding subscores at 6 months and quality of life at 3 months were observed in those receiving silodosin .
RESULTS	The pressure flow studies demonstrated that silodosin had significantly enlarged the bladder capacity when the first non-voiding contraction was seen at 3 and 12 months ( 3M : 127.1 74.8 vs. 118.2 83.9 mL , p = 0.001 ; 12M : 123.7 79.3 vs. 100.3 73.4 mL , p = 0.01 ) ; however , there were no improvements in the bladder outlet obstruction index ( BOOI ) or urinary flow .
CONCLUSIONS	Silodosin temporarily improved LUTS , but did not improve the BOOI after ( 125 ) I implantation in the prostate .

###24486033
OBJECTIVE	The purpose of this prospective and randomized clinical study was to assess differences in patient morbidity between minimally invasive lateral sinus elevation ( study group , n = 14 ) and conventional one-stage lateral sinus elevation ( control group , n = 12 ) .
OBJECTIVE	It was hypothesized that trauma to soft tissue was reduced in the study group .
METHODS	Optical 3-D imaging was assessed blinded on days 1 and 7 after surgery to determine the visible soft tissue swelling of the upper lip and cheeks .
METHODS	Postoperative pain and discomfort were evaluated by a visual analogue scale ( VAS ; scale 0-10 ) .
RESULTS	Immediately and on day 1 after surgery , the study group patients rated pain and discomfort as 2.4 [ SD 1.7 ] and 3.1 [ SD 2.1 ] , respectively , on the VAS ; while , the controls rated 4 [ SD 1.6 ] and 5.6 [ SD 1.7 ] , respectively .
RESULTS	The mean facial soft tissue volume change , assessed on day 1 after surgery , was 5.0 cm ( 3 ) [ range : 0.2-9 .2 ] for the study group and 15.5 cm ( 3 ) ( 9.3-21 .55 ) for the controls ( p = 0.00 ) .
CONCLUSIONS	Despite the small number of patients in this prospective study , 3-D based minimally invasive one-stage lateral sinus elevation resulted in favourable patient morbidity with less postoperative visible facial soft tissue volume changes .

###25200271
OBJECTIVE	The purpose of this study was to investigate if differences in spinal height changes in healthy individuals were observed after a period of spinal unloading using repetitive as compared with sustained lumbar extension exercises .
METHODS	This study used a pretest , posttest , crossover design .
METHODS	Asymptomatic participants were recruited using convenience sampling .
METHODS	Thirty-two participants ( 15 male ; 17 female ) without back pain were included in the data analysis ( mean , 24.4 years ; range , 20-41 years ) .
METHODS	Participants performed sustained or repetitive prone lumbar extension exercises after 1 hour of sustained spinal unloading .
METHODS	Spinal height was measured using a stadiometer before and after the repetitive and sustained prone lumbar extension exercises .
RESULTS	Paired t tests revealed no significant difference in spine height after repetitive ( P = .774 ) or sustained ( P = .545 ) prone lumbar extension after a period of spinal unloading .
RESULTS	No significant difference between spinal height changes occurred between sustained ( mean [ SD ] , -0.28 [ 2.59 ] mm ) and repetitive ( mean [ SD ] , -0.12 [ 2.42 ] mm ) lumbar extension ( P = .756 ) .
CONCLUSIONS	In this group of asymptomatic individuals , sustained and repetitive lumbar extension exercises did not appear to affect spinal height after a period of spinal unloading .

###25005011
BACKGROUND	Skills in single-incision laparoscopic surgery ( SILS ) are difficult to acquire .
BACKGROUND	Simulation training leads to skill acquisition but circumstances about skill deterioration are unclear .
BACKGROUND	The aim of this study was to evaluate skill acquisition and retention after single-incision laparoscopic simulation training .
METHODS	From October 2013 to January 2014 , 30 surgically naive participants underwent a SILS training curriculum and completed two validated tasks ( peg transfer , precision cutting ) with subsequent testing to assess acquisition of skills ( baseline testing , BT ) .
METHODS	The participants were randomized into two groups and skill retention testing ( RT ) was measured after 4 weeks ( group A ) or 12 weeks ( group B ) .
METHODS	Task completion was measured in time with penalties for inaccurate performance .
RESULTS	A SILS training curriculum was established .
RESULTS	90 % of the participants completed the training successfully and reached the required levels of proficiency .
RESULTS	Comparison of BT and RT revealed significantly better RT performances for peg transfer and precision cutting in group A ( P < 0.05 ) .
RESULTS	These effects were not seen for RT in group B. Evaluating the RT performance of both groups , group A showed a non-significant trend for improved peg transfer and precision cutting compared to group B.
CONCLUSIONS	A proficiency-based training curriculum for acquisition of basic SILS skills was successfully established in our department .
CONCLUSIONS	The results of this study indicate that acquired SILS skills are well retained for a short period without training ( 4 weeks ) but a longer non-training period ( 12 weeks ) resulted in a significant loss of acquired skills .
CONCLUSIONS	For enhancement of surgical skills , specialised SILS training curricula could be developed for novices and inexperienced surgeons ; however , continuous training is essential to maintain these acquired skills .

###26090731
OBJECTIVE	To reduce radiation exposure of frequently performed radiographs of the knee in follow-up of total-knee arthroplasty ensuring accurate assessment by using objective quality control criteria .
METHODS	In this prospective randomized study 278 radiographs of the knee in follow-up of total-knee arthroplasty were performed with standard and 37 % reduced radiation dose .
METHODS	The evaluation of the plain-radiographs was conducted using the following criteria : bone-implant interface , implant-surface character , implant-implant discrimination and periarticular heterotopic ossification .
METHODS	Two radiologists evaluated these criteria using a score ranging from 1 ( definitely assessable ) to 4 ( not assessable ) .
METHODS	If a single criterion had been evaluated with a score 3 or more than 2 criteria with 2 points , the radiograph was score das `` not assessable '' .
METHODS	The study was designed as non-inferiority-trial .
RESULTS	100 % of examined radiographs were scored as assessable , hence no statistical inferiority between the examinations with standard and reduced dose could be observed .
RESULTS	Singular assessment of the defined criteria was likewise dose-independent .
CONCLUSIONS	Plain-radiography of the knee following total-knee arthroplasty can be performed with 63 % of standard dose without loss of diagnostic validity .
CONCLUSIONS	Due to the non-inferiority of digital radiographs of the knee joint after total-knee arthroplasty done with 37 % reduced image receiver dose we recommend the tested speed class of SC 800 as a new reference value for digital radiographs with this indication .

###24355831
BACKGROUND	The present study was conducted to investigate the influence of different operating table heights on the quality of laryngeal view and the discomfort of the anaesthetist during enodotracheal intubation .
METHODS	Eight anaesthetists participated , to each of whom 20 patients were allocated .
METHODS	Before induction of anaesthesia , the height of the operating table was adjusted to place the patient 's forehead at one of four landmarks on the anaesthetist 's body ( the order being determined by block randomization with eight blocks ) : umbilicus ( Group U ) , lowest rib margin ( Group R ) , xiphoid process ( Group X ) , and nipple ( Group N ) .
METHODS	Next , the anaesthetist began the laryngoscopy and evaluated the grade of laryngeal view .
METHODS	For this ` initial posture ' , the anaesthetist was not allowed to adjust his or her posture ( flexion or extension of the neck , lower back , knee , and ankle ) .
METHODS	This laryngeal view was then re-graded after these constraints were relaxed .
METHODS	At each posture , the anaesthetist 's joint movements and discomfort during mask ventilation or intubation were evaluated .
RESULTS	The laryngeal view before postural changes was better in Group N than in Group U ( P = 0.003 ) .
RESULTS	The objective and subjective measurements of neck or lower back flexion during intubation were higher in Group U than in Groups X and N ( P < 0.01 for each ) .
RESULTS	The improvement of laryngeal view resulting from postural changes correlated with the anaesthetist 's discomfort score before the postural change ( P < 0.01 ) .
CONCLUSIONS	Higher operating tables ( at the xiphoid process and nipple level of the anaesthetist ) can provide better laryngeal views with less discomfort during tracheal intubation .
CONCLUSIONS	TRIAL REGISTRY NUMBER : NCT01649973 ( clinicaltrials.gov ) .

###24274808
OBJECTIVE	This study examines the efficacy of an online screening decision aid ( DA ) for men with a family history of prostate cancer .
METHODS	Unaffected Australian men ( 40-79 years ) with at least one affected relative completed the first online questionnaire , were randomized to read either the tailored DA ( intervention ) or nontailored information about prostate cancer screening ( control ) , then completed a questionnaire postreading and 12 months later .
METHODS	The primary outcome was decisional conflict regarding prostate specific antigen ( PSA ) testing .
METHODS	The impact of the DA on longitudinal outcomes was analyzed by using random intercept mixed effects models .
METHODS	Logistic and linear regressions were used to analyze the impact of the DA on screening behavior and decision regret .
METHODS	Stage of decision-making was tested as a moderator for decisional conflict and decision regret .
METHODS	The frequency of online material access was recorded .
RESULTS	The DA had no effect on decisional conflict , knowledge , inclination toward PSA testing , accuracy of perceived risk , or screening behavior .
RESULTS	However , among men considering PSA testing , those who read the DA had lower decision regret compared with men who read the control materials , = 0.34 , p < .001 , 95 % confidence interval ( CI ) = [ .22 , .53 ] .
CONCLUSIONS	This is the first study to our knowledge to evaluate the uptake and efficacy of an online screening DA among men with a family history of prostate cancer .
CONCLUSIONS	Men who were undecided about screening at baseline benefitted from the DA , experiencing less regret 12 months later .
CONCLUSIONS	In relation to decisional conflict , the control materials may have operated as a less complex and equally informative DA .

###24438381
BACKGROUND	Despite decades of nutrition education , the prevalence of unhealthy dietary patterns is still high and inequalities in intake between high and low socioeconomic groups still exist .
BACKGROUND	Therefore , it is important to innovate and improve existing nutrition education interventions .
BACKGROUND	This paper describes the development , design and evaluation protocol of a web-based computer-tailored nutrition education intervention for adults targeting fruit , vegetable , high-energy snack and fat intake .
BACKGROUND	This intervention innovates existing computer-tailored interventions by not only targeting motivational factors , but also volitional and self-regulation processes and environmental-level factors .
METHODS	The intervention development was guided by the Intervention Mapping protocol , ensuring a theory-informed and evidence-based intervention .
METHODS	Two versions of the intervention were developed : a basic version targeting knowledge , awareness , attitude , self-efficacy and volitional and self-regulation processes , and a plus version additionally addressing the home environment arrangement and the availability and price of healthy food products in supermarkets .
METHODS	Both versions consist of four modules : one for each dietary behavior , i.e. fruit , vegetables , high-energy snacks and fat .
METHODS	Based on the self-regulation phases , each module is divided into three sessions .
METHODS	In the first session , feedback on dietary behavior is provided to increase awareness , feedback on attitude and self-efficacy is provided and goals and action plans are stated .
METHODS	In the second session goal achievement is evaluated , reasons for failure are explored , coping plans are stated and goals can be adapted .
METHODS	In the third session , participants can again evaluate their behavioral change and tips for maintenance are provided .
METHODS	Both versions will be evaluated in a three-group randomized controlled trial with measurements at baseline , 1-month , 4-months and 9-months post-intervention , using online questionnaires .
METHODS	Both versions will be compared with a generic nutrition information control condition .
METHODS	The primary outcomes are fruit , vegetable , high-energy snack and fat intake .
CONCLUSIONS	The evaluation study will provide insight into the short - and long-term efficacy of both intervention versions in adults .
CONCLUSIONS	Additionally , differences in the efficacy among high - and low-educated people will be examined .
CONCLUSIONS	If these interventions are effective , two well-developed interventions will become available for the implementation and promotion of healthy dietary patterns among both high - and low-educated adults in the Netherlands .
BACKGROUND	Dutch Trial Registry NTR3396 .

###25175029
BACKGROUND	Lymphoceles are a common complication after pelvic lymphadenectomy in women with gynecologic malignancies .
BACKGROUND	Although typically asymptomatic , lymphoceles can superinfect requiring medical or surgical intervention .
BACKGROUND	A single center randomized controlled trial provided first evidence , that a collagen-fibrin patch ( Tachosil ) is effective in the prevention of symptomatic lymphoceles after pelvic lymphadenectomy .
METHODS	We will perform a multicentre , blinded , randomized , controlled trial comprising 140 women with gynecologic malignancies undergoing pelvic lymphadenectomy .
METHODS	Women will be randomly allocated to Tachosil application or no application .
METHODS	Primary outcome is efficacy , defined as lymphocele CTCAE 4.03 grade 2 within four weeks after surgery .
METHODS	Secondary outcomes are asymptomatic lymphocele verified by ultrasound , medical or surgical intervention .
METHODS	Assuming a two-sided 5 % significance level , a power of 80 % , and a drop out rate of 10 % , a sample size of 68 patients per group was calculated to detect a 66 % absolute decrease in symptomatic lymphoceles .
CONCLUSIONS	We aim to provide further evidence for the efficacy of a collagen-fibrin patch in the prevention of symptomatic lymphoceles in women with gynecological malignancies undergoing pelvic lymphadenectomy .
BACKGROUND	This study is registered at ClinicalTrials.gov ( NCT01470677 , protocol ID : TACHO-1 ) .
BACKGROUND	This study is registered at the EudraCT database ( EudraCT number : 2011-003115-34 ) .

###24248803
BACKGROUND	South African alcohol-serving establishments ( i.e. , shebeens ) offer unique opportunities to reduce HIV risks among men who drink .
OBJECTIVE	To test an individual - and a social structural-level HIV prevention intervention for men who drink in shebeens .
METHODS	Twelve matched pairs of township neighbourhoods were randomized to receive either ( i ) an HIV prevention intervention ( guided by Social Action Theory ) to reduce sexual risk and increase risk reduction communication in social networks , or ( ii ) an attention-matched control intervention that focused on the prevention of relationship violence .
METHODS	At the individual level , the interventions delivered skills building workshops focused on sexual risk reduction .
METHODS	At the social structural level , the intervention aimed to increase conversations about safer sex among men in the shebeens , distributed small media and implemented community educational events .
METHODS	Individual-level outcomes were assessed by following the workshop cohorts for 1 year ( N = 984 ) , and community-level outcomes were examined through cross-sectional community surveys conducted for 1 year in the shebeens ( N = 9,678 ) .
RESULTS	Men in the HIV prevention workshops demonstrated greater condom use , more HIV prevention-oriented conversations and greater perceptions of safer sex norms than men in the comparison workshops .
RESULTS	Changes at the community level demonstrated significant differences in condom use , although the pattern was not consistent over time .
CONCLUSIONS	Multi-level interventions that target men who drink in South African shebeens may help reduce risks for HIV and other sexually transmitted infections .

###24367796
BACKGROUND	There is no standardized method for cold pressor pain tasks across experiments .
BACKGROUND	Temperature , apparatus and aspects of experimenters vary widely among studies .
BACKGROUND	It is well known that experimental pain tolerance is influenced by setting as well as the sex of the experimenter .
BACKGROUND	It is not known whether other contextual factors influence experimental pain reporting .
OBJECTIVE	The present two-part experiment examines whether minimizing and standardizing interactions with laboratory personnel ( eg , limiting interaction with participants to consenting and questions and not during the actual pain task ) eliminates the influence of examiner characteristics on subjective pain reports and whether using different cold pain apparatus ( cooler versus machine ) influences reports .
METHODS	The present experiment manipulated the gender of the experimenter ( male , female and transgender ) and the type of cold pressor task ( CPT ) apparatus ( ice cooler versus refrigerated bath circulator ) .
METHODS	Participants conducted the CPT at one of two pain levels ( 5C or 16C ) without an experimenter present .
RESULTS	Men and women showed lower pain sensitivity when they were processed by biological male personnel than by biological female personnel before the CPT .
RESULTS	Women who interacted with a transgendered researcher likewise reported higher pain sensitivity than women processed by biological male or female researchers .
RESULTS	The type of CPT apparatus , despite operating at equivalent temperatures , also influenced subjective pain reports .
CONCLUSIONS	The findings show that even minimal interactions with laboratory personnel who differ in gender , and differences in laboratory materials impact the reliable measurement of pain .
CONCLUSIONS	More standardized protocols for measuring pain across varying research and clinical settings should be developed .

###24886064
BACKGROUND	Alteplase is the only approved thrombolytic agent for acute ischaemic stroke .
BACKGROUND	The overall benefit from alteplase is substantial , but some evidence indicates that alteplase also has negative effects on the ischaemic brain .
BACKGROUND	Tenecteplase may be more effective and less harmfull than alteplase , but large randomised controlled phase 3 trials are lacking .
BACKGROUND	The Norwegian Tenecteplase Stroke Trial ( NOR-TEST ) aims to compare efficacy and safety of tenecteplase vs. alteplase .
METHODS	NOR-TEST is a multi-centre PROBE ( prospective randomised , open-label , blinded endpoint ) trial designed to establish superiority of tenecteplase 0.4 mg/kg ( single bolus ) as compared with alteplase 0.9 mg/kg ( 10 % bolus +90 % infusion/60minutes ) for consecutively admitted patients with acute ischaemic stroke eligible for thrombolytic therapy , i.e. patients a ) admitted < 4hours after symptoms onset ; b ) admitted < 4hours after awakening with stroke symptoms c ) receiving bridging therapy before embolectomy.Randomisation tenecteplase : alteplase is 1:1 .
METHODS	The primary study endpoint is favourable functional outcome defined as modified Rankin Scale 0-1 at 90days .
METHODS	Secondary study endpoints are : 1 ) haemorrhagic transformation ( haemorrhagic infarct/haematoma ) ; 2 ) symptomatic cerebral haemorrhage on CT 24-48 hours ; 3 ) major neurological improvement at 24hours ; 4 ) recanalisation at 24-36 hours ; 5 ) death .
CONCLUSIONS	NOR-TEST may establish a novel approach to acute ischaemic stroke treatment .
CONCLUSIONS	A positive result will lead to a more effective , safer and easier treatment for all acute ischaemic stroke pasients.NOR-TEST is reviewed and approved by the Regional Committee for Medical and Health Research Ethics ( 2011/2435 ) , and The Norwegian Medicines Agency ( 12/01402 ) .
CONCLUSIONS	NOR-TEST is registered with EudraCT No 2011-005793-33 and in ClinicalTrials.gov ( NCT01949948 ) .

###25837528
BACKGROUND	The intensity of pain after cardiac surgery is often underestimated , and inadequate pain control may be associated with poorer quality of recovery .
BACKGROUND	The aim of this investigation was to examine the effect of intraoperative methadone on postoperative analgesic requirements , pain scores , patient satisfaction , and clinical recovery .
METHODS	Patients undergoing cardiac surgery with cardiopulmonary bypass ( n = 156 ) were randomized to receive methadone ( 0.3 mg/kg ) or fentanyl ( 12 g/kg ) intraoperatively .
METHODS	Postoperative analgesic requirements were recorded .
METHODS	Patients were assessed for pain at rest and with coughing 15min and 2 , 4 , 8 , 12 , 24 , 48 , and 72h after tracheal extubation .
METHODS	Patients were also evaluated for level of sedation , nausea , vomiting , itching , hypoventilation , and hypoxia at these times .
RESULTS	Postoperative morphine requirements during the first 24h were reduced from a median of 10mg in the fentanyl group to 6mg in the methadone group ( median difference [ 99 % CI ] , -4 [ -8 to -2 ] mg ; P < 0.001 ) .
RESULTS	Reductions in pain scores with coughing were observed during the first 24h after extubation ; the level of pain with coughing at 12h was reduced from a median of 6 in the fentanyl group to 4 in the methadone group ( -2 [ -3 to -1 ] ; P < 0.001 ) .
RESULTS	Improvements in patient-perceived quality of pain management were described in the methadone group .
RESULTS	The incidence of opioid-related adverse events was not increased in patients administered methadone .
CONCLUSIONS	Intraoperative methadone administration resulted in reduced postoperative morphine requirements , improved pain scores , and enhanced patient-perceived quality of pain management .

###25340477
BACKGROUND	Involving family as part of the patient 's rehabilitation plan of care might enhance the management of COPD .
BACKGROUND	The primary aim of this study was to investigate the impact of a family-based pulmonary rehabilitation ( PR ) program on patients and family members ' coping strategies to manage COPD .
METHODS	Family dyads ( patient and family member ) were randomly assigned to family-based ( experimental ) or conventional ( control ) PR .
METHODS	Patients from both groups underwent exercise training three times a week and psychosocial support and education once a week , during 12 weeks .
METHODS	Family members of the family-based PR attended the psychosocial support and education sessions together with patients .
METHODS	In the conventional PR , family members did not participate .
METHODS	Family coping and psychosocial adjustment to illness were assessed in patients and family members of both groups .
METHODS	Patients ' exercise tolerance , functional balance , muscle strength , and health-related quality of life were also measured .
METHODS	All measures were collected pre/post-program .
RESULTS	Forty-two dyads participated ( patients : FEV1 , 70.4 % 22.1 % predicted ) .
RESULTS	Patients ( P = .048 ) and family members ( P = .004 ) in the family-based PR had significantly greater improvements in family coping than the control group .
RESULTS	Family members of the family-based PR had significantly greater changes in sexual relationships ( P = .026 ) and in psychologic distress ( P = .033 ) compared with the control group .
RESULTS	Patients from both groups experienced significant improvements in exercise tolerance , functional balance , knee extensors strength , and health-related quality of life after intervention ( P < .001 ) .
CONCLUSIONS	This research supports family-based PR programs to enhance coping and psychosocial adjustment to illness of the family system .
BACKGROUND	ClinicalTrials.gov ; No. : NCT02048306 ; URL : www.clinicaltrials.gov .

###25747263
OBJECTIVE	The Italian Association of Medical Physics ( AIFM ) started a working group dedicated to stereotactic body radiotherapy ( SBRT ) treatment .
OBJECTIVE	In this work , we performed a multicenter planning study on patients who were candidates for SBRT in the treatment of prostate cancer with the aim of evaluating the dosimetric consistency among the different hospitals .
METHODS	Fourteen centers were provided the contours of 5 patients .
METHODS	Plans were performed following the dose prescription and constraints for organs at risk ( OARs ) of a reference paper .
METHODS	The dose prescription was 35 Gy in five fractions for the planning target volume ( PTV ) .
METHODS	Different techniques were used ( 3D-CRT , fixed-Field IMRT , VMAT , CyberKnife ) .
METHODS	Plans were compared in terms of dose-volume histogram ( DVH ) parameters .
METHODS	Furthermore , the median DVH was calculated and one patient was re-planned .
RESULTS	A total of 70 plans were compared .
RESULTS	The maximum dose to the body was 107.94.5 % ( range 101.5-116 .3 % ) .
RESULTS	Dose at 98 % ( D98 % ) and mean dose to the clinical target volume ( CTV ) were 102.00.9 % ( global range 101.1-102 .9 % ) and 105.10.6 % ( range 98.6-124 .6 % ) .
RESULTS	Similar trends were found for D95 % and mean dose to the PTV .
RESULTS	Important differences were found in terms of the homogeneity index .
RESULTS	Doses to OARs were heterogeneous .
RESULTS	The subgroups with the same treatment planning system showed differences comparable to the differences of the whole group .
RESULTS	In the re-optimized plans , DVH differences among institutes were reduced and OAR sparing improved .
CONCLUSIONS	Important dosimetric differences with possible clinical implications , in particular related to OARs , were found .
CONCLUSIONS	Replanning allowed a reduction in the OAR dose and decreased standard deviations .
CONCLUSIONS	Multicenter clinical trials on SBRT should require a preplanning study to standardize the optimization procedure .

###24372829
BACKGROUND	Delayed gastric emptying symptoms interfere with the absorption of oral medications .
BACKGROUND	Intranasal metoclopramide is being developed as an alternative to oral metoclopramide for patients with diabetic gastroparesis .
METHODS	To compare the efficacy and safety of metoclopramide nasal spray to oral tablets in diabetic patients with symptoms of gastroparesis , this randomized , open-label , parallel design study randomized subjects to 10 or 20 mg nasal spray or 10 mg tablet four times a day for 6 weeks .
METHODS	Efficacy was evaluated using a total symptom score ( TSS ) .
RESULTS	Eighty-nine subjects were enrolled .
RESULTS	For the intention to treat population , both nasal dose groups ( 10 and 20 mg ) had lower TSS with treatment compared to the oral 10 mg group .
RESULTS	The change from baseline in TSS for nasal 20 mg was greater than the oral 10 mg at Week 6 ( p = 0.026 ) .
RESULTS	For the per-protocol population , there was a significant difference in the TSS between baseline and Week 6 for both the nasal 10 mg ( p = 0.026 ) and the nasal 20 mg ( p = 0.008 ) cohorts compared to the oral 10 mg group .
RESULTS	Based on the definition of a responder , 88.9 % of subjects who received oral 10 mg , 91.2 % who received nasal 10 mg , and 97.1 % who received nasal 20 metoclopramide were classified as responders .
RESULTS	The side-effect profile of the metoclopramide nasal spray was favorable .
RESULTS	More side effects , especially nausea , occurred with the oral tablets .
CONCLUSIONS	Metoclopramide nasal spray offers better symptom control than metoclopramide oral tablet in diabetic patients with symptoms of gastroparesis .

###24292991
BACKGROUND	A previous randomized study showed that clarithromycin decreases the risk of death due to ventilator-associated pneumonia and shortens the time until infection resolution .
BACKGROUND	The efficacy of clarithromycin was tested in a larger population with sepsis .
METHODS	Six hundred patients with systemic inflammatory response syndrome due to acute pyelonephritis , acute intra-abdominal infections or primary Gram-negative bacteraemia were enrolled in a double-blind , randomized , multicentre trial .
METHODS	Clarithromycin ( 1 g ) was administered intravenously once daily for 4 days consecutively in 302 patients ; another 298 patients were treated with placebo .
METHODS	Mortality was the primary outcome ; resolution of infection and hospitalization costs were the secondary outcomes .
RESULTS	The groups were well matched for demographics , disease severity , microbiology and appropriateness of the administered antimicrobials .
RESULTS	Overall 28 day mortality was 17.1 % ( 51 deaths ) in the placebo arm and 18.5 % ( 56 deaths ) in the clarithromycin arm ( P = 0.671 ) .
RESULTS	Nineteen out of 26 placebo-treated patients with septic shock and multiple organ dysfunctions died ( 73.1 % ) compared with 15 out of 28 clarithromycin-treated patients ( 53.6 % , P = 0.020 ) .
RESULTS	The median time until resolution of infection was 5 days in both arms .
RESULTS	In the subgroup with severe sepsis/shock , this was 10 days in the placebo arm and 6 days in the clarithromycin arm ( P = 0.037 ) .
RESULTS	The cost of hospitalization was lower after treatment with clarithromycin ( P = 0.044 ) .
RESULTS	Serious adverse events were observed in 1.3 % and 0.7 % of placebo - and clarithromycin-treated patients , respectively ( P = 0.502 ) .
CONCLUSIONS	Intravenous clarithromycin did not affect overall mortality ; however , administration shortened the time to resolution of infection and decreased the hospitalization costs .

###24412161
BACKGROUND	The rate and effect of coronary interventions and induced hypothermia after out-of-hospital cardiac arrest ( OHCA ) are unknown .
BACKGROUND	We measured the association of early ( 24h after arrival ) coronary angiography , reperfusion , and induced hypothermia with favorable outcome after OHCA .
METHODS	We performed a secondary analysis of a multicenter clinical trial ( NCT00394706 ) conducted between 2007 and 2009 in 10 North American regions .
METHODS	Subjects were adults ( 18 years ) hospitalized after OHCA with pulses sustained 60min .
METHODS	We measured the association of early coronary catheterization , percutaneous coronary intervention , fibrinolysis , and induced hypothermia with survival to hospital discharge with favorable functional status ( modified Rankin Score3 ) .
RESULTS	From 16,875 OHCA subjects , 3981 ( 23.6 % ) arrived at 151 hospitals with sustained pulses .
RESULTS	1317 ( 33.1 % ) survived to hospital discharge , with 1006 ( 25.3 % ) favorable outcomes .
RESULTS	Rates of early coronary catheterization ( 19.2 % ) , coronary reperfusion ( 17.7 % ) or induced hypothermia ( 39.3 % ) varied among hospitals , and were higher in hospitals treating more subjects per year .
RESULTS	Odds of survival and favorable outcome increased with hospital volume ( per 5 subjects/year OR 1.06 ; 95 % CI : 1.04-1 .08 and OR 1.06 ; 95 % CI : 1.04 , 1.08 , respectively ) .
RESULTS	Survival and favorable outcome were independently associated with early coronary angiography ( OR 1.69 ; 95 % CI 1.06-2 .70 and OR 1.87 ; 95 % CI 1.15-3 .04 ) , coronary reperfusion ( OR 1.94 ; 95 % CI 1.34-2 .82 and OR 2.14 ; 95 % CI 1.46-3 .14 ) , and induced hypothermia ( OR 1.36 ; 95 % CI 1.01-1 .83 and OR 1.42 ; 95 % CI 1.04-1 .94 ) .
CONCLUSIONS	Early coronary intervention and induced hypothermia are associated with favorable outcome and are more frequent in hospitals that treat higher numbers of OHCA subjects per year .

###24412554
BACKGROUND	Previous studies conducted on animals linked consumption of Nigella sativa L. seeds ( NS ) to decreased anxiety and improved memory .
BACKGROUND	The present study , which was carried out at a boarding school in Bangladesh , was designed to examine probable effect of NS on mood , anxiety and cognition in adolescent human males .
METHODS	Forty-eight healthy adolescent human males aged between 14 to 17 years were randomly recruited as volunteers and were randomly split into two groups : A ( n = 24 ) and B ( n = 24 ) .
METHODS	The treatment procedure for group A and B were one capsule of 500 mg placebo and 500 mg NS respectively once daily for four weeks .
METHODS	All the volunteers were assessed for cognition with modified California verbal learning test-II ( CVLT-II ) , mood with Bond-Lader scale and anxiety with State-Trait Anxiety Inventory ( STAI ) at the beginning and after four weeks of either NS or placebo ingestion .
CONCLUSIONS	No parameter showed statistically significant variation between A and B in measurements in the beginning , but after 4 weeks of one capsule of NS 500 mg intake , there was statistically significant variation of mood within group B but there was not statistically significant variation between group A and B. No significant variation was found in state anxiety within groups and between group A and B but in case of trait anxiety , significant variation was found within group B but not between group A and B.
CONCLUSIONS	In case of CVLT II , there was significant variation within B in immediate short-term recall at trial 4 and 5 whereas this difference was found only in case of trial 5 between group A and B. Within group B , short term-free recall , long-term free recall and long-term cued recall had statistical difference whereas between group A and B long-term free recall and long-term cued recall had statistical difference .
CONCLUSIONS	No parameters had significant variation within group A after placebo intake for 4 weeks .
CONCLUSIONS	Over the 4 weeks study period , the use of NS as a nutritional supplement been observed to - stabilize mood , decrease anxiety and modulate cognition positively .
CONCLUSIONS	However , long term study is suggested before using NS extensively .

###24286408
BACKGROUND	Although noninvasive positive pressure ventilation ( NPPV ) has been successfully used for various kinds of acute respiratory failure , the data are limited regarding its application in postoperative respiratory failure after cardiac surgery .
BACKGROUND	Therefore , we conducted a prospective randomized control study in a university surgical intensive care unit to evaluate the efficacy and safety of NPPV in the treatment of acute respiratory failure after cardiac surgery , and explore the predicting factors of NPPV failure .
METHODS	From September 2011 to November 2012 patients with acute respiratory failure after cardiac surgery who had indication for the use of NPPV were randomly divided into a NPPV treatment group ( NPPV group ) and the conventional treatment group ( control group ) .
METHODS	The between-group differences in the patients ' baseline characteristics , re-intubation rate , tracheotomy rate , ventilator associated pneumonia ( VAP ) incidence , in-hospital mortality , mechanical ventilation time after enrollment ( MV time ) , intensive care unit ( ICU ) and postoperative hospital stays were compared .
METHODS	The factors that predict NPPV failure were analyzed .
RESULTS	During the study period , a total of 139 patients who had acute respiratory failure after cardiac surgery were recorded , and 95 of them met the inclusion criteria , which included 59 males and 36 females with a mean age of ( 61.5 11.2 ) years .
RESULTS	Forty-three patients underwent coronary artery bypass grafting ( CABG ) , 23 underwent valve surgery , 13 underwent CABG + valve surgery , 13 underwent major vascular surgery , and three underwent other surgeries .
RESULTS	The NPPV group had 48 patients and the control group had 47 patients .
RESULTS	In the NPPV group , the re-intubation rate was 18.8 % , tracheotomy rate was 12.5 % , VAP incidence was 0 , and the in-hospital mortality was 18.8 % , significantly lower than in the control group 80.9 % , 29.8 % , 17.0 % and 38.3 % respectively , P < 0.05 or P < 0.01 .
RESULTS	The MV time and ICU stay ( expressed as the median ( P25 , P75 ) ) were 18.0 ( 9.2 , 35.0 ) hours and 4.0 ( 2.0 , 5.0 ) days , which were significantly shorter than in the control group , 96.0 ( 26.0 , 240.0 ) hours and 6.0 ( 4.0 , 9.0 ) days respectively , P < 0.05 or P < 0.01 .
RESULTS	The postoperative hospital stays of the two groups were similar .
RESULTS	The univariate analysis showed that the NPPV success subgroup had more patients with acute lung injury ( ALI ) ( 17 vs. 0 , P = 0.038 ) , fewer patients with pneumonia ( 2 vs. 7 , P < 0.001 ) and lower acute physiology and chronic health evaluation II ( APACHE II ) scores ( 16.1 2.8 vs. 21.8 3.2 , P < 0.001 ) .
RESULTS	Multivariate analysis showed that pneumonia ( P = 0.027 ) and a high APACHE II score > 20 ( P = 0.002 ) were the independent risk factors of NPPV failure .
CONCLUSIONS	We conclude that NPPV can be applied in selected patients with acute respiratory failure after cardiac surgery to reduce the need of re-intubation and improve clinical outcome as compared with conventional treatment .
CONCLUSIONS	Pneumonia and a high APACHE II score > 20 might be the independent risk factors of NPPV failure in this group of patients .

###24365449
OBJECTIVE	Rifaximin is a gut-selective , oral antimicrobial agent shown to reduce the recurrence of overt hepatic encephalopathy ( HE ) and HE-related hospitalizations in a 6-month , randomized , controlled trial ( RCT ) .
OBJECTIVE	We performed a phase 3 , open-label maintenance study to assess the safety and rate of hospitalization with long-term rifaximin use .
METHODS	We conducted a 24-month , open-label maintenance study of rifaximin ( 550 mg , twice daily ) in patients with HE who participated in the previous RCT of rifaximin or new patients enrolled from March 2007 to December 2010 .
METHODS	Safety was assessed ( adverse events , clinical laboratory parameters ) for the integrated population of all patients , who were given rifaximin 550 mg twice daily ( all-rifaximin population , N = 392 ) .
METHODS	Safety and hospitalization data were compared between the group given placebo in the original RCT ( n = 159 ) and those given rifaximin ( n = 140 ) .
RESULTS	In the all-rifaximin population , the median exposure to rifaximin was 427.0 days ( range , 2-1427 d ) , with 510.5 person-years of exposure .
RESULTS	The profile and rate of adverse events with long-term rifaximin treatment were similar to those of the original RCT .
RESULTS	There was no increase in the rate of infections , including with Clostridium difficile , or development of bacterial antibiotic resistance .
RESULTS	Rates of hospitalizations with long-term rifaximin administration remained low : the HE-related hospitalization rate , normalized for exposure ( 0.21 ; all-rifaximin population ) , was similar to that of the rifaximin group in the original RCT ( 0.30 ) , and lower than that for the placebo group ( 0.72 ) .
CONCLUSIONS	Long-term treatment ( 24 mo ) with rifaximin ( 550 mg , twice daily ) appears to provide a continued reduction in the rate of HE-related and all-cause hospitalization , without an increased rate of adverse events .
CONCLUSIONS	ClinicalTrials.gov number : NCT00686920 .

###25256185
BACKGROUND	Physical activity levels of Australia 's ageing population are declining and coincidentally rates of overweight and obesity are increasing .
BACKGROUND	Adequate levels of physical activity and a healthy diet are recognised as important lifestyle factors for the maintenance of a healthy weight and prevention of chronic diseases .
BACKGROUND	Retirement village ( RV ) residents rarely engage in physical activity and nutrition programmes offered , with poor attendance and low use of existing facilities such as on-site fitness centres and classes and nutrition seminars .
BACKGROUND	The RV provides a unique setting to access and engage with this older target group , to test the effectiveness of strategies to increase levels of physical activity , improve nutrition and maintain a healthy weight .
METHODS	This cluster-randomised controlled trial will evaluate a physical activity , nutrition and healthy weight management intervention for insufficiently active ( ` not achieving 150 min of moderate-intensity physical activity per week ' ) adults aged 60-75 residing in RV 's .
METHODS	A total of 400 participants will be recruited from 20 randomly selected RV 's in Perth , Western Australia .
METHODS	Villages will be assigned to either the intervention group ( n = 10 ) or the control group ( n = 10 ) each containing 200 participants .
METHODS	The Retirement Village Physical Activity and Nutrition for Seniors ( RVPANS ) programme is a home-based physical activity and nutrition programme that includes educational resources , along with facilitators who will motivate and guide the participants during the 6-month intervention .
METHODS	Descriptive statistics and mixed regression models will be performed to assess the intervention effects .
METHODS	This trial will evaluate an intervention for the modification of health risk factors in the RV setting .
METHODS	Such research conducted in RV 's has been limited .
BACKGROUND	Curtin University Human Research Ethics Committee ( approval number : HR128/2012 ) .
BACKGROUND	Dissemination of the study results will occur through publications , reports , conference presentations and community seminars .
BACKGROUND	Australia and New Zealand Clinical Trial Registry ( ACTRN12612001168842 ) .

###25253446
BACKGROUND	The supplementation of fat to lactating dairy cows has long been used as a management tool to increase dietary energy density for improving cow production , reproduction and to alleviate negative energy balance .
BACKGROUND	Attempts have been made to investigate the effect of canola meal on plasma metabolites in lactating cows , but the results have been diverse and inconsistent .
BACKGROUND	To our current knowledge , there is a dearth of published information on the utilization of Crude Degummed Canola Oil ( CDCO ) in pasture-based dairy systems .
BACKGROUND	Therefore , the objective of this study was to investigate the changes in plasma metabolite profiles of pasture-based , primiparous , Holstein-Friesian cows supplemented with varying dietary levels of CDCO for eight weeks .
BACKGROUND	The study tested the hypothesis that feeding grazing primiparous Holstein-Friesian cows for eight weeks with incremental levels of CDCO supplement will decrease plasma non-esterified fatty acids ( NEFA ) and - hydroxybutyrate ( BHBA ) , but increase plasma cholesterol and glucose metabolites .
RESULTS	Twenty lactating primiparous Holstein-Friesian cows 40 days in milk were randomly allotted into four treatment groups that consisted of a wheat-based , pelleted basal diet with no supplemental CDCO ( control ) , basal diet with CDCO added at 25 ml/kgDM ( DM ; dry matter ) ( low ) , 35 ml/kgDM ( medium ) and 50 ml/kgDM ( high ) in an eight-week feeding trial , after two weeks of adjustment .
RESULTS	Treatment influenced BHBA but had no effect on plasma NEFA , cholesterol and glucose metabolite profiles ( P > 0.05 ) .
RESULTS	However , week of supplementation had a significant effect ( P < 0.05 ) on BHBA , NEFA and glucose concentrations .
CONCLUSIONS	We concluded that with the exception of BHBA , CDCO at current levels of supplementation does not alter the plasma metabolite profiles of grazing primiparous cows .
CONCLUSIONS	The lack of significant differences across treatments seems to indicate that higher levels of CDCO than the current levels used in this study , are probably needed .
CONCLUSIONS	Furthermore , the duration of supplementation with CDCO had a greater impact on plasma metabolites than the levels of supplementation .
CONCLUSIONS	Our findings also suggest that primiparous cows grazing high quality pastures during spring have sufficient energy intakes to prevent negative energy balance at 40 days in milk without the need for added fat supplements .

###26017649
OBJECTIVE	To investigate the variations in blood glucose levels , hemodynamic effects and patient anxiety scores during tooth extraction in patients with type 2 diabetes mellitus T2DM and coronary disease under local anesthesia with 2 % lidocaine with or without epinephrine .
METHODS	This is a prospective randomized study of 70 patients with T2DM with coronary disease who underwent oral surgery .
METHODS	The study was double blind with respect to the glycemia measurements .
METHODS	Blood glucose levels were continuously monitored for 24 hours using the MiniMed Continuous Glucose Monitoring System .
METHODS	Patients were randomized into two groups : 35 patients received 5.4 mL of 2 % lidocaine , and 35 patients received 5.4 mL of 2 % lidocaine with 1:100,000 epinephrine .
METHODS	Hemodynamic parameters ( blood pressure and heart rate ) and anxiety levels were also evaluated .
RESULTS	There was no difference in blood glucose levels between the groups at each time point evaluated .
RESULTS	Surprisingly , both groups demonstrated a significant decrease in blood glucose levels over time .
RESULTS	The groups showed no significant differences in hemodynamic and anxiety status parameters .
CONCLUSIONS	The administration of 5.4 mL of 2 % lidocaine with epinephrine neither caused hyperglycemia nor had any significant impact on hemodynamic or anxiety parameters .
CONCLUSIONS	However , lower blood glucose levels were observed .
CONCLUSIONS	This is the first report using continuous blood glucose monitoring to show the benefits and lack of side effects of local anesthesia with epinephrine in patients with type 2 diabetes mellitus and coronary disease .

###25531146
OBJECTIVE	An acid-base imbalance precedes renal disease progression in patients with chronic kidney disease ( CKD ) .
OBJECTIVE	Little is known about the effects of a low-salt diet ( LSD ) on net endogenous acid production ( NEAP ) levels in CKD patients using angiotensin receptor blockade .
METHODS	We enrolled a total of 202 nondiabetic CKD patients who underwent an 8-week treatment with olmesartan from the original trial [ Effects of Low Sodium Intake on the Antiproteinuric Efficacy of Olmesartan in Hypertensive Patients with Albuminuria ( ESPECIAL ) trial : NCT01552954 ] .
METHODS	The patients were divided into good - and poor-LSD-compliance groups .
RESULTS	During the interventional 8 weeks , the NEAP in the good-compliance group increased compared to the control group ( 12.9 32.0 vs. -2.0 35.0 mmol/day , p = 0.002 ) .
RESULTS	NEAP was positively associated with the good-LSD-compliance group in the fully adjusted analyses ( r = 0.135 , p = 0.016 ) .
RESULTS	The additional reduction of 2.39 g/day of protein intake with a reduction of 1 g/day of salt intake did not increase the NEAP under angiotensin II receptor blockade ( ARB ) treatment with an LSD ( r = 0.546 , p < 0.001 ) .
CONCLUSIONS	We found that an LSD may increase the NEAP in nondiabetic CKD patients using ARB , which suggests that additional acid producing-protein restriction should be required to prevent the NEAP from rising .

###25545331
BACKGROUND	Coenzyme Q10 ( CoQ10 ) supplementation is the most popular therapy for statin myalgia among both physicians and patients despite limited and conflicting evidence of its efficacy .
OBJECTIVE	This study examined the effect of coenzyme Q10 ( CoQ10 ) supplementation on simvastatin-associated muscle pain , muscle strength and aerobic performance in patients with confirmed statin myalgia .
METHODS	Statin myalgia was confirmed in 120 patients with prior symptoms of statin myalgia using an 8-week randomized , double-blind crossover trial of simvastatin 20mg/d and placebo .
METHODS	Forty-one subjects developed muscle pain with simvastatin but not with placebo and were randomized to simvastatin 20mg/d combined with CoQ10 ( 600mg/d ubiquinol ) or placebo for 8 weeks .
METHODS	Muscle pain ( Brief Pain Inventory [ BPI ] ) , time to pain onset , arm and leg muscle strength , and maximal oxygen uptake ( VO2max ) were measured before and after each treatment .
RESULTS	Serum CoQ10 increased from 1.30.4 to 5.22.3 mcg/mL with simvastatin and CoQ10 , but did not increase with simvastatin and placebo ( 1.30.3 to 0.80.2 ) ( p < 0.05 ) .
RESULTS	BPI pain severity and interference scores increased with simvastatin therapy ( both p < 0.01 ) , irrespective of CoQ10 assignment ( p = 0.53 and 0.56 ) .
RESULTS	There were no changes in muscle strength or VO2max with simvastatin with or without CoQ10 ( all p > 0.10 ) .
RESULTS	Marginally more subjects reported pain with CoQ10 ( 14 of 20 vs 7 of 18 ; p = 0.05 ) .
RESULTS	There was no difference in time to pain onset in the CoQ10 ( 3.02.0 weeks ) vs. placebo ( 2.42.1 wks ) groups ( p = 0.55 ) .
RESULTS	A similar lack of CoQ10 effect was observed in 24 subjects who were then crossed over to the alternative treatment .
CONCLUSIONS	Only 36 % of patients complaining of statin myalgia develop symptoms during a randomized , double-blind crossover of statin vs placebo .
CONCLUSIONS	CoQ10 supplementation does not reduce muscle pain in patients with statin myalgia .
CONCLUSIONS	Trial RegistrationNCT01140308 ; www.clinicaltrials.gov .

###24434887
OBJECTIVE	The purpose of this study was to investigate the effects of whole-body vibration training on muscle strength and balance in children with diplegic cerebral palsy .
METHODS	Fifteen children were assigned to the experimental group , which received whole-body vibration training ( 9 mins per day , 5 days per week ) .
METHODS	Another 15 were assigned to the control group , which participated in a traditional physical therapy exercise program for 3 successive months .
METHODS	Baseline and posttreatment assessments were performed using the Biodex isokinetic dynamometer to evaluate the knee extensors peak torque at 60 degrees per second and 90 degrees per second and using the Biodex balance system to evaluate stability index .
RESULTS	The children in the experimental group showed a significant improvement when compared with those in the control group ( P < 0.001 ) .
RESULTS	The peak torque at 60 degrees per second and 90 degrees per second after treatment was 28.8 0.45 and 47.5 0.7 N m and 30.9 0.68 and 54.2 1.7 N m for the control and the experimental group , respectively .
RESULTS	The overall stability index after treatment was 2.75 and 2.2 for the control group and the experimental group , respectively .
CONCLUSIONS	Whole-body vibration training may be a useful tool for improving muscle strength and balance in children with diplegic cerebral palsy .

###24946627
OBJECTIVE	To evaluate the short-term and long-term effects on treatment of neck pain caused by cervical spondylosis with the combination of acupuncture and moxibustion with seed-size moxa cone .
METHODS	One hundred and forty-five patients of neck pain were randomly divided into an acupuncture-moxibustion group ( 49 cases ) , an acupuncture group ( 48 cases ) and a moxibustion group ( 48 cases ) .
METHODS	Acupoints of Bailao ( Extra ) , Dazhui ( GV 14 ) , Jianzhongshu ( SI15 ) and Zhongzhu ( TE 3 ) were adopted for all the 3 groups .
METHODS	Acupuncture was applied at all the acupoints with 20 min needling retention for the acupuncture group .
METHODS	Moxibustion with seed-size moxa cone was used with 5 cones on each point for the moxibustion group .
METHODS	And both acupuncture and moxibustion with seed-size moxa cone were adopted for the acupuncture-moxibustion group .
METHODS	The treatment was applied once every 3 days , and 10 treatments should be finished within 4 weeks .
METHODS	Follow-up should be carried out for 3 months .
METHODS	The short-term and long-term effects were evaluated with the scores of Northwick Park Pain Questionnaire ( NPQ ) and McGill Pain Questionnaire ( MPQ ) as the indices of therapeutic effect .
RESULTS	The NPQ score and MPQ score of all the 3 groups after the treating course and the 3-month follow-up were both decreased when compared with those before the treatment ( all P < 0.05 ) .
RESULTS	The scores of NPQ and MPQ the acupuncture-moxibustion group were lower than that of the other two groups .
RESULTS	And the difference had obvious significance ( P < 0.05 ) .
RESULTS	High efficiency of pain relieving for cervical spondylosis could be found in all the 3 groups , which showed that short-term and long-term effects were good for all the 3 groups .
RESULTS	And the highest curative effect could be found in acupuncture-moxibustion group .
CONCLUSIONS	Combination of acupuncture and moxibustion with seed-size moxa cone has reached a superior effect in short-term and long-term for neck pain caused by cervical spondylosis .

###24885793
BACKGROUND	Polycystic ovary syndrome ( PCOS ) patients are at increased risk of pregnancy complications , which may impair pregnancy outcome .
BACKGROUND	Transfer of fresh embryos after superovulation may lead to abnormal implantation and placentation and further increase risk for pregnancy loss and complications .
BACKGROUND	Some preliminary data suggest that elective embryo cryopreservation followed by frozen-thawed embryo transfer into a hormonally primed endometrium could result in a higher clinical pregnancy rate than that achieved by fresh embryo transfer .
METHODS	This study is a multicenter , prospective , randomized controlled clinical trial ( 1:1 treatment ratio of fresh vs. elective frozen embryo transfers ) .
METHODS	A total of 1,180 infertile PCOS patients undergoing the first cycle of in vitro fertilization ( IVF ) or intracytoplasmic sperm injection will be enrolled and randomized into two parallel groups .
METHODS	Participants in group A will undergo fresh embryo transfer on day 3 after oocyte retrieval , and participants in group B will undergo elective embryo cryopreservation after oocyte retrieval and frozen-thawed embryo transfer in programmed cycles .
METHODS	The primary outcome is the live birth rate .
METHODS	Our study is powered at 80 to detect an absolute difference of 10 at the significance level of 0.01 based on a two-sided test .
CONCLUSIONS	We hypothesize that elective embryo cryopreservation and frozen-thawed embryo transfer will reduce the incidence of pregnancy complications and increase the live birth rate in PCOS patients who need IVF to achieve pregnancy .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01841528 .

###25150180
OBJECTIVE	To compare the safety and efficiency of plasmakinetic enucleation of the prostate ( PKEP ) with that of plasmakinetic resection of the prostate ( PKRP ) in the treatment of benign prostatic hyperplasia ( BPH ) .
METHODS	Three hundred ten patients diagnosed to have BPH were randomized to undergo either PKEP or PKRP .
METHODS	The perioperative data and postoperative outcomes followed at 1 , 3 , 6 , 12 , 18 , and 24 months after surgery were recorded and compared in the groups classified according to the baseline prostate volume : 60 mL and > 60 mL .
RESULTS	There were no significant differences in the preoperative data .
RESULTS	Compared with PKRP , PKEP costs longer operative time ( 56.1 14.6 vs 41.3 9.6 min ; P < .001 ) for prostate volume 60 mL , but reduced operative time ( 75.6 12.3 vs 88.7 14.3 minutes ; P < .001 ) and caused less blood loss ( 167.6 44.4 vs 225.7 49.5 mL ; P < .001 ) for prostate volume > 60 mL .
RESULTS	However , regardless of prostate size , the incidence of transient incontinence after PKEP was higher .
RESULTS	The postoperative improvement among these groups in International Prostate Symptom Score , quality of life , and maximal flow rate was similar at 24-month follow-up .
CONCLUSIONS	PKEP and PKRP are both safe and effective treatments for BPH independent of prostate size .
CONCLUSIONS	Despite that the incidence of transient incontinence after PKEP was higher , PKEP was significantly superior to PKRP in operative time and blood loss for prostate volume > 60 mL and may become the modern alternative to PKRP for large BPH .

###24686029
OBJECTIVE	Paravertebral block ( PVB ) has been shown to be an ideal aid for analgesia after thoracic or abdominal surgery .
OBJECTIVE	The authors studied the safety and efficacy of the single-dose and bilateral ultrasound-guided ( USG ) - PVB before combined thoracoscopic-laparoscopic esophagectomy ( TLE ) along with intravenous sufentanil analgesia as a method of pain relief in comparison with intravenous sufentanil as a sole analgesic agent .
METHODS	Prospective , randomized study .
METHODS	Single university hospital .
METHODS	Fifty-two patients undergoing TLE .
METHODS	A USG-PVB was performed before surgery using a solution of 30 mL of 0.5 % ropivacaine by 3 injections of 10 mL each at the right T5 and bilateral T8 ( PVB group , n = 26 ) or the saline injection of 10 mL at every site ( control group , n = 26 ) .
RESULTS	Successful PVBs were achieved in all patients of the PVB group .
RESULTS	Intraoperative mean remifentanil usage and end-tidal sevoflurane concentration were lower in the PVB group ( p < 0.001 ) .
RESULTS	Hemodynamic parameters were stable in both groups .
RESULTS	Postoperative pain scores both at rest and on coughing were lower during the first 8 hours in the PVB group than those in the control group ( p < 0.05 ) .
RESULTS	Cumulative sufentanil consumption delivered by patient-controlled analgesia ( PCA ) was significantly lower in the PVB group at all time points ( p < 0.05 ) .
RESULTS	Postoperative pulmonary function was better at the third postoperative day in the PVB group ( p < 0.05 ) , with quicker hospital discharge and lower hospital costs ( p < 0.05 ) .
CONCLUSIONS	The single-dose and bilateral PVB given before TLE combined with sufentanil may provide better postoperative analgesia and early discharge in patients undergoing TLE .

###24961394
METHODS	Dysregulation of lipid homeostasis is related to multiple major healthcare problems .
METHODS	The aim of this study was to investigate the effects of n-3 fatty acid ( FA ) and polyphenol rich diets on plasma and HDL fraction lipidomic profiles in subjects at high cardiovascular risk .
RESULTS	Ultra performance LC coupled to quadrupole TOF/MS mass spectrometry global lipidomic profiling was applied to plasma and HDL fraction from an 8 wk randomized intervention with four isoenergetic diets , differing in their natural n-3 FA and polyphenols content , in 78 subjects with a high BMI , abdominal obesity , and at least one other feature of the metabolic syndrome .
RESULTS	Dependency network analysis showed a different pattern of associations between lipidomics , dietary , and clinical variables after the dietary interventions .
RESULTS	The most remarkable associations between variables were observed after the diet high in n-3 FA and polyphenols , as the inverse association between gallic acid intake and LDL cholesterol levels , which was indirectly associated with a HDL cluster exclusively comprised lysophospholipids .
CONCLUSIONS	This is the first human randomized controlled trial showing direct and indirect associations with lipid molecular species and clinical variables of interest in the evaluation of the metabolic syndrome after diets naturally rich in polyphenols .

###24619793
BACKGROUND	Chemotherapy-induced peripheral neuropathy ( CIPN ) is a significant side effect of taxane and platinum-based chemotherapy .
BACKGROUND	Several studies have supported the potential benefit of glutathione for the prevention of platinum-induced CIPN .
BACKGROUND	The current trial was designed to determine whether glutathione would prevent CIPN as a result of carboplatin/paclitaxel therapy .
METHODS	In total , 185 patients who received treatment with paclitaxel and carboplatin were accrued between December 4 , 2009 and December 19 , 2011 .
METHODS	Patients were randomized to receive either placebo ( n = 91 ) or 1.5 g/m ( 2 ) glutathione ( n = 94 ) over 15 minutes immediately before chemotherapy .
METHODS	CIPN was assessed using the European Organization for Research and Treatment of Cancer Quality-of-Life ( EORTC-QLQ ) 20-item , CIPN-specific ( CIPN20 ) sensory subscale and the National Cancer Institute Common Terminology Criteria for Adverse Events ( CTCAE ) , version 4.0 .
RESULTS	There were no statistically significant differences between the 2 study arms with regard to : 1 ) peripheral neurotoxicity , as assessed using both the EORTC-QLQ-CIPN20 ( P = .21 ) and the CTCAE scales ( P = .449 for grade 2 neurotoxicity ; P = .039 for time to development of grade 2 neuropathy , in favor of the placebo ) ; 2 ) the degree of paclitaxel acute pain syndrome ( P = .30 for patients who received paclitaxel every 3-4 weeks and P = .002 , in favor of the placebo , for patients who received weekly paclitaxel ) ; 3 ) the time to disease progression ( P = .63 ) ; or 4 ) apparent toxicities .
RESULTS	Subgroup analyses did not reveal any evidence of benefit in any particular subgroup .
CONCLUSIONS	The results from this study do not support the use of glutathione for the prevention of paclitaxel/carboplatin-induced CIPN .

###25336193
BACKGROUND	The single most distressing symptom for patients with advanced esophageal cancer is dysphagia .
BACKGROUND	Amongst the more effective treatments for relief of dysphagia is insertion of a self-expanding metal stent ( SEMS ) .
BACKGROUND	It is possible that the addition of a palliative dose of external beam radiotherapy may prolong the relief of dysphagia and provide additional survival benefit .
BACKGROUND	The ROCS trial will assess the effect of adding palliative radiotherapy after esophageal stent insertion .
METHODS	The study is a randomized multicenter phase III trial , with an internal pilot phase , comparing stent alone versus stent plus palliative radiotherapy in patients with incurable esophageal cancer .
METHODS	Eligible participants are those with advanced esophageal cancer who are in need of stent insertion for primary management of dysphagia .
METHODS	Radiotherapy will be administered as 20 Gray ( Gy ) in five fractions over one week or 30 Gy in 10 fractions over two weeks , within four weeks of stent insertion .
METHODS	The internal pilot will assess rates and methods of recruitment ; pre-agreed criteria will determine progression to the main trial .
METHODS	In total , 496 patients will be randomized in a 1:1 ratio with follow up until death .
METHODS	The primary outcome is time to progression of patient-reported dysphagia .
METHODS	Secondary outcomes include survival , toxicity , health resource utilization , and quality of life .
METHODS	An embedded qualitative study will explore the feasibility of patient recruitment by examining patients ' motivations for involvement and their experiences of consent and recruitment , including reasons for not consenting .
METHODS	It will also explore patients ' experiences of each trial arm .
CONCLUSIONS	The ROCS study will be a challenging trial studying palliation in patients with a poor prognosis .
CONCLUSIONS	The internal pilot design will optimize methods for recruitment and data collection to ensure that the main trial is completed on time .
CONCLUSIONS	As a pragmatic trial , study strengths include collection of all follow-up data in the usual place of care , and a focus on patient-reported , rather than disease-orientated , outcomes .
CONCLUSIONS	Exploration of patient experience and health economic analyses will be integral to the assessment of benefit for patients and the NHS .
BACKGROUND	The trial was registered with Current Controlled Trials ( registration number : ISRCTN12376468 ) on 10 July 2012 .

###25006914
OBJECTIVE	Pathophysiology of tinnitus known to accompany nearly all disorders in hearing system has not been fully understood , and therefore , there are some difficulties in evaluation and treatment thereof .
OBJECTIVE	The objective of the current study is to research the effectiveness of transcranial magnetic stimulation ( TMS ) application in treatment of tinnitus .
METHODS	Sixty patients aged between 15 and 70 years who applied to a polyclinic of Ear-Nose-Throat Department , Cerrahpasa Medical Faculty , Istanbul University , because of the complaint of tinnitus between January 2009 and July 2009 were selected using simple random sampling method .
METHODS	The treatment group and the placebo group were separated randomly as to include 30 patients .
METHODS	The tinnitus loudness , tinnitus frequency , tinnitus subjective score , and tinnitus handicap inventory results were compared before application of TMS and after 1 month .
RESULTS	It was found that the difference of tinnitus handicap inventory score within the TMS group ( before the treatment : mean , 52.76 ; SD , 15.8 ; after the treatment : mean , 44.4 ; SD , 13.57 ) was statistically significant ( P < 0.0001 ) and the difference of tinnitus handicap inventory score within the placebo group ( before the treatment : mean , 51.46 ; SD , 15.41 ; after the treatment : mean , 51.13 ; SD , 16.86 ) was significantly insignificant ( P = 0.848 ) .
RESULTS	When tinnitus severities determined at the beginning and end of the treatment were evaluated within each group , it was found that the difference of loudness within the group subjected to TMS was statistically significant ( P < 0.0001 ) but the difference of loudness within the placebo group was statistically insignificant ( P = 0.490 ) .
RESULTS	When tinnitus subjective scores were evaluated within each group before and after the treatment , the difference of subjective score within the group subjected to transcranial magnetic stimulation was statistically significant ( P < 0.0001 ) , and the difference of subjective score within the placebo group was statistically significant ( P = 0.168 ) .
CONCLUSIONS	The studies showed that low-frequency repeating TMS is useful in the treatment of chronic tinnitus .
CONCLUSIONS	In the current study performed on the patients with chronic tinnitus , it was shown that low-frequency repeating TMS has a statistically significant success when compared with the placebo group .

###24885437
BACKGROUND	Although prompt reperfusion treatment restores normal epicardial flow , microvascular dysfunction may persist in some patients with acute coronary syndrome ( ACS ) .
BACKGROUND	Impaired myocardial perfusion is caused by intraluminal platelets , fibrin thrombi and neutrophil plugging ; antiplatelet agents play a significant role in terms of protecting against thrombus microembolization .
BACKGROUND	A novel antiplatelet agent , ticagrelor , is a non-thienopyridine , direct P2Y12 blocker that has shown greater , more rapid and more consistent platelet inhibition than clopidogrel .
BACKGROUND	However , the effects of ticagrelor on the prevention of microvascular dysfunction are uncertain .
BACKGROUND	The present study is a comparison between clopidogrel and ticagrelor use for preventing microvascular dysfunction in patients with ST elevation or non-ST elevation myocardial infarction ( STEMI or NSTEMI , respectively ) .
METHODS	The TIME trial is a single-center , randomized , open-label , parallel-arm study designed to demonstrate the superiority of ticagrelor over clopidogrel .
METHODS	A total of 152 patients with a spectrum of STEMI or NSTEMI will undergo prospective random assignment to clopidogrel or ticagrelor ( 1:1 ratio ) .
METHODS	The primary endpoint is an index of microcirculatory resistance ( IMR ) measured after percutaneous coronary intervention ( PCI ) ; the secondary endpoint is wall motion score index assessed at 3 months by using echocardiography .
CONCLUSIONS	The TIME trial is the first study designed to compare the protective effect of clopidogrel and ticagrelor on coronary microvascular dysfunction in patients with STEMI and NSTEMI .
BACKGROUND	ClinicalTrials.gov : NCT02026219 .
BACKGROUND	Registration date : 24 December 2013 .

###25919527
OBJECTIVE	Opioid-dependent patients often use the emergency department ( ED ) for medical care .
OBJECTIVE	To test the efficacy of 3 interventions for opioid dependence : ( 1 ) screening and referral to treatment ( referral ) ; ( 2 ) screening , brief intervention , and facilitated referral to community-based treatment services ( brief intervention ) ; and ( 3 ) screening , brief intervention , ED-initiated treatment with buprenorphine/naloxone , and referral to primary care for 10-week follow-up ( buprenorphine ) .
METHODS	A randomized clinical trial involving 329 opioid-dependent patients who were treated at an urban teaching hospital ED from April 7 , 2009 , through June 25 , 2013 .
METHODS	After screening , 104 patients were randomized to the referral group , 111 to the brief intervention group , and 114 to the buprenorphine treatment group .
METHODS	Enrollment in and receiving addiction treatment 30 days after randomization was the primary outcome .
METHODS	Self-reported days of illicit opioid use , urine testing for illicit opioids , human immunodeficiency virus ( HIV ) risk , and use of addiction treatment services were the secondary outcomes .
RESULTS	Seventy-eight percent of patients in the buprenorphine group ( 89 of 114 [ 95 % CI , 70 % -85 % ] ) vs 37 % in the referral group ( 38 of 102 [ 95 % CI , 28 % -47 % ] ) and 45 % in the brief intervention group ( 50 of 111 [ 95 % CI , 36 % -54 % ] ) were engaged in addiction treatment on the 30th day after randomization ( P < .001 ) .
RESULTS	The buprenorphine group reduced the number of days of illicit opioid use per week from 5.4 days ( 95 % CI , 5.1-5 .7 ) to 0.9 days ( 95 % CI , 0.5-1 .3 ) vs a reduction from 5.4 days ( 95 % CI , 5.1-5 .7 ) to 2.3 days ( 95 % CI , 1.7-3 .0 ) in the referral group and from 5.6 days ( 95 % CI , 5.3-5 .9 ) to 2.4 days ( 95 % CI , 1.8-3 .0 ) in the brief intervention group ( P < .001 for both time and intervention effects ; P = .02 for the interaction effect ) .
RESULTS	The rates of urine samples that tested negative for opioids did not differ statistically across groups , with 53.8 % ( 95 % CI , 42 % -65 % ) in the referral group , 42.9 % ( 95 % CI , 31 % -55 % ) in the brief intervention group , and 57.6 % ( 95 % CI , 47 % -68 % ) in the buprenorphine group ( P = .17 ) .
RESULTS	There were no statistically significant differences in HIV risk across groups ( P = .66 ) .
RESULTS	Eleven percent of patients in the buprenorphine group ( 95 % CI , 6 % -19 % ) used inpatient addiction treatment services , whereas 37 % in the referral group ( 95 % CI , 27 % -48 % ) and 35 % in the brief intervention group ( 95 % CI , 25 % -37 % ) used inpatient addiction treatment services ( P < .001 ) .
CONCLUSIONS	Among opioid-dependent patients , ED-initiated buprenorphine treatment vs brief intervention and referral significantly increased engagement in addiction treatment , reduced self-reported illicit opioid use , and decreased use of inpatient addiction treatment services but did not significantly decrease the rates of urine samples that tested positive for opioids or of HIV risk .
CONCLUSIONS	These findings require replication in other centers before widespread adoption .
BACKGROUND	clinicaltrials.gov Identifier : NCT00913770 .

###24274213
BACKGROUND	In cerebrospinal fluid ( CSF ) leakage endoscopic repair , lumbar drains ( LDs ) were used in an attempt to increase success rates .
BACKGROUND	To critically assess the relationship between use of LDs and recurrent leaks , we embarked on this randomized prospective study .
METHODS	Patients undergoing CSF leak repair between 2000 and 2012 were randomized into two groups : 75 patients were managed without LDs and in the other group of 75 patients an LD was always placed .
METHODS	Different parameters were analyzed to identify their relationship with failures : occurrence of increased intracranial pressure ( ICP ) , body mass index , smoking habits , existence of diabetes , chronic corticosteroid use , previous sinus surgery , etiology ( traumatic , iatrogenic , or spontaneous leak ) , site , and size of the CSF leak .
RESULTS	Success rate was 93 % for the whole group .
RESULTS	Patients managed with LDs attained 95 % success rate and those without LD attained 92 % ; the difference is not significant ( p = 0.2 ) .
RESULTS	The only factor predictive of recurrence is increased ICP : 77 % success rate versus 97 % for traumatic leaks and 96 % for iatrogenic leaks .
RESULTS	Recurrence rates were identical in the two groups with increased ICP , regardless of the use of a LD ( 23 % ) .
CONCLUSIONS	In this study , success rates of CSF repair were not associated with the use of LDs .
CONCLUSIONS	However , the small number of cases with high success rates precludes appropriate statistical analysis .

###24394884
OBJECTIVE	Migraine is a common form of headache that is a major burden for patients who often seek emergency care .
OBJECTIVE	The goal of this study was to compare the effectiveness of intravenous non-steroidal anti-inflammatory medication ( dexketoprofen ) with paracetamol ( acetaminophen ) in the treatment of an acute migraine attack .
METHODS	This prospective , randomised , double blind , controlled study was conducted in a tertiary care emergency unit .
METHODS	Study patients were randomised into two groups to receive either 50 mg of dexketoprofen trometamol or 1000 mg of paracetamol intravenously by rapid infusion in 150 mL of normal saline .
METHODS	Pain reduction was measured at baseline , and after 15 and 30 min , using a Visual Analogue Scale ( VAS ) ) as the primary outcome .
METHODS	VAS is a measurement tool ranging from 0 ( no pain ) to 100 mm ( worst pain ) .
RESULTS	200 patients were included in the final analysis .
RESULTS	Mean ( SD ) age of the study subjects was 30.1 11 years and 81 % ( n = 162 ) were women .
RESULTS	Median reduction in VAS score at 30 min was 56 ( IQR 30-78 .5 ) for the paracetamol group and 55 ( IQR 34-75 ) for the dexketoprofen group , with a difference of 1 mm ( 95 % CI -7 to 10 ) between the two groups .
CONCLUSIONS	Intravenous paracetamol and dexketoprofen appear to produce equivalent pain relief for migraine in the emergency department .
CONCLUSIONS	CLINICALTRIALS.GOV NO : NCT01730326 .

###24954805
BACKGROUND	The prognosis for locally advanced gastric cancer is poor despite advances in adjuvant chemotherapy .
BACKGROUND	We did the Stomach cancer Adjuvant Multi-Institutional group Trial ( SAMIT ) to assess the superiority of sequential treatment ( paclitaxel then tegafur and uracil [ UFT ] or paclitaxel then S-1 ) compared with monotherapy ( UFT or S-1 ) and also the non-inferiority of UFT compared with S-1 .
METHODS	We did this randomised phase 3 trial with a two-by-two factorial design at 230 hospitals in Japan .
METHODS	We enrolled patients aged 20-80 years with T4a or T4b gastric cancer , who had had D2 dissection and a ECOG performance score of 0-1 .
METHODS	Patients were randomly assigned to one of four treatment groups with minimisation for tumour size , lymph node metastasis , and study site .
METHODS	Patients received UFT only ( 267 mg/m ( 2 ) per day ) , S-1 only ( 80 mg/m ( 2 ) per day ) for 14 days , with a 7-day rest period or three courses of intermittent weekly paclitaxel ( 80 mg/m ( 2 ) ) followed by either UFT , or S-1 .
METHODS	Treatment lasted 48 weeks in monotherapy groups and 49 weeks in the sequential treatment groups .
METHODS	The primary endpoint was disease-free survival assessed by intention to treat .
METHODS	We assessed whether UFT was non-inferior to S-1 with a non-inferiority margin of 133 .
METHODS	This trial was registered at UMIN Clinical Trials Registry , number C000000082 .
RESULTS	We randomly assigned 1495 patients between Aug 3 , 2004 , and Sept 29 , 2009.374 patients were assigned to receive UFT alone , 374 to receive S-1 alone , 374 to received paclitaxel then UFT , and 373 to receive paclitaxel then S-1 .
RESULTS	We included 1433 patients in the primary analysis after at least 3 years of follow-up ( 359 , 364 , 355 , and 355 in each group respectively ) .
RESULTS	Protocol treatment was completed by 215 ( 60 % ) patients in the UFT group , 224 ( 62 % ) in the S-1 group , 242 ( 68 % ) in the paclitaxel then UFT group , and 250 ( 70 % ) in the paclitaxel then S-1 group .
RESULTS	3-year disease-free survival for monotherapy was 540 % ( 95 % CI 502-576 ) and that of sequential treatment was 572 % ( 534-608 ; hazard ratio [ HR ] 092 , 95 % CI 080-107 , p = 0273 ) .
RESULTS	3-year disease-free survival for the UFT group was 530 % ( 95 % CI 492-566 ) and that of the S-1 group was 582 % ( 544-618 ; HR 081 , 95 % CI 070-093 , p = 00048 ; pnon-inferiority = 0151 ) .
RESULTS	The most common grade 3-4 haematological adverse event was neutropenia ( 41 [ 11 % ] of 359 patients in the UFT group , 48 [ 13 % ] of 363 in the S-1 group , 46 [ 13 % ] of 355 in the paclitaxel then UFT group , and 83 [ 23 % ] of 356 in the paclitaxel then S-1 group ) .
RESULTS	The most common grade 3-4 non-haematological adverse event was anorexia ( 21 [ 6 % ] , 24 [ 7 % ] , seven [ 2 % ] , and 18 [ 5 % ] , respectively ) .
CONCLUSIONS	Sequential treatment did not improve disease-free survival , and UFT was not non-inferior to S-1 ( and S-1 was superior to UFT ) , therefore S-1 monotherapy should remain the standard treatment for locally advanced gastric cancer in Japan .
BACKGROUND	Epidemiological and Clinical Research Information Network .

###24809264
OBJECTIVE	To explore the effect of high positive end-expiratory pressure ( PEEP ) for the treatment of neurological pulmonary edema ( NPE ) in patients undergoing mechanical ventilation , and to look for the best mechanical ventilation strategy to improve the prognosis .
METHODS	A prospective study was conducted , and 120 patients with NEP admitted to Department of Critical Care Medicine of the First Affiliated Hospital of Guangxi Traditional Chinese Medical University from January 2010 to August 2013 were enrolled and divided into two groups according to random number table ( n = 60 in each group ) .
METHODS	The patients in two groups were given empiric treatment for the disease , and they underwent mechanical ventilation .
METHODS	In the normal PEEP group PEEP was 3-10 cmH2O ( 1 cmH2O = 0.098 kPa ) , and in the high PEEP group PEEP was 11-30 cmH2O , and all the rest parameters were the same .
METHODS	Clinical indices before and 7 days after treatment , and 28-day morality rate were compared between two groups .
RESULTS	The 28-day morality rate in high PEEP group was obviously lower than that in the normal PEEP group [ 25.0 % ( 15/60 ) vs. 65.0 % ( 39/60 ) , ( 2 ) = 6.465 , P = 0.011 ] .
RESULTS	The clinical signs in both groups were improved after treatment .
RESULTS	Compared with the normal PEEP group , the clinical indices in high PEEP group were more significantly improved .
RESULTS	There were significant differences in body temperature ( 37.40.5 centigrade vs. 38.50.6 centigrade ) , respiratory rate ( 18.33.1 times/min vs. 23.33.5 times/min ) , heart rate ( 94.78.5 beats/min vs. 113.58.0 beats/min ) , white blood cell count ( WBC : 12.52.1 10 ( 9 ) / L vs. 17.11.7 10 ( 9 ) / L ) , acute physiology and chronic health evaluation II ( APACHEII ) score ( 15.63.2 vs. 19.83.7 ) , Glasgow coma score ( GCS : 12.52.1 vs. 8.52.9 ) , gastrointestinal dysfunction score ( 3.93.0 vs. 3.62.4 ) , oxygenation index ( PaO2/FiO2 : 196.545.1 mmHg vs. 134.122.3 mmHg ) , serum creatinine ( SCr : 86.535.6 mol/L vs. 98.537.7 mol/L ) , total bilirubin ( TBil : 39.723.5 mol/L vs. 41.516.2 mol/L ) , C-reacting protein ( CRP : 53.721.4 mmol/L vs. 108.426.3 mmol/L ) , prothrombin time ( PT : 15.02.1 s vs. 20.42.2 s ) , activated partial thromboplastin time ( APTT : 37.34.9 s vs. 56.713.6 s ) , international normalized ratio ( INR : 2.520.64 vs. 4.010.77 ) , extra vascular lung water index ( EVLWI : 7.531.21 mL/kg vs. 15.853.41 mL/kg ) , pulmonary vascular permeability index ( PVPI : 6.070.89 vs. 9.471.26 ) , mean arterial pressure ( MAP : 87.310.9 mmHg vs. 98.713.6 mmHg ) , cardiac output ( CO : 7.151.42 L/min vs. 5.651.82 L/min ) , systemic vascular resistance index ( SVRI : 112.49.5 KP vs. 136.511.9 KP ) , and blood lactate ( 2.531.23 mmol/L vs. 5.812.17 mmol/L ) between high PEEP group and normal PEEP group ( P < 0.05 or P < 0.01 ) .
CONCLUSIONS	Prognosis can be improved in NPE patients with the use of high PEEP in mechanical ventilation .

###24453026
OBJECTIVE	To assess the contribution of contrast material in detecting and evaluating enthesitis of pelvic entheses by MRI .
METHODS	Sixty-seven hip or pelvic 1.5-T MRIs ( 30:37 male : female , mean age : 53 years ) were retrospectively evaluated for the presence of hamstring and gluteus medius ( GM ) enthesitis by two readers ( a resident and an experienced radiologist ) .
METHODS	Short tau inversion recovery ( STIR ) and T1-weighted pre - and post-contrast ( T1 + Gd ) images were evaluated by each reader at two sessions .
METHODS	A consensus reading of two senior radiologists was regarded as the gold standard .
METHODS	Clinical data was retrieved from patients ' referral form and medical files .
METHODS	Cohen 's kappa was used for intra - and inter-observer agreement calculation .
METHODS	Diagnostic properties were calculated against the gold standard reading .
RESULTS	A total of 228 entheses were evaluated .
RESULTS	Gold standard analysis diagnosed 83 ( 36 % ) enthesitis lesions .
RESULTS	Intra-reader reliability for the experienced reader was significantly ( p = 0.0001 ) higher in the T1 + Gd images compared to the STIR images ( hamstring : k = 0.84 / 0.45 , GM : k = 0.84 / 0.47 ) .
RESULTS	Sensitivity and specificity increased from 0.74 / 0.8 to 0.87 / 0.9 in the STIR images and T1 + Gd sequences .
RESULTS	Intra-reader reliability for the inexperienced reader was lower ( p > 0.05 ) .
CONCLUSIONS	Evidence showing that contrast material improves the reliability , sensitivity , and specificity of detecting enthesitis supports its use in this setting .

###25025601
OBJECTIVE	Irritable bowel syndrome ( IBS ) is a chronic , disabling condition that greatly compromises patient functioning .
OBJECTIVE	The aim of this study was to assess the impact of a 6-week twice per week Iyengar yoga ( IY ) program on IBS symptoms in adolescents and young adults ( YA ) with IBS compared with a usual-care waitlist control group .
METHODS	Assessments of symptoms , global improvement , pain , health-related quality of life , psychological distress , functional disability , fatigue , and sleep were collected pre - and posttreatment .
METHODS	Weekly ratings of pain , IBS symptoms , and global improvement were also recorded until 2-month follow-up .
METHODS	A total of 51 participants completed the intervention ( yoga = 29 ; usual-care waitlist = 22 ) .
RESULTS	Baseline attrition was 24 % .
RESULTS	On average , the yoga group attended 75 % of classes .
RESULTS	Analyses were divided by age group .
RESULTS	Relative to controls , adolescents ( 14-17 years ) assigned to yoga reported significantly improved physical functioning , whereas YA ( 18-26 years ) assigned to yoga reported significantly improved IBS symptoms , global improvement , disability , psychological distress , sleep quality , and fatigue .
RESULTS	Although abdominal pain intensity was statistically unchanged , 44 % of adolescents and 46 % of YA reported a minimally clinically significant reduction in pain following yoga , and one-third of YA reported clinically significant levels of global symptom improvement .
RESULTS	Analysis of the uncontrolled effects and maintenance of treatment effects for adolescents revealed global improvement immediately post-yoga that was not maintained at follow-up .
RESULTS	For YA , global improvement , worst pain , constipation , and nausea were significantly improved postyoga , but only global improvement , worst pain , and nausea maintained at the 2-month follow-up .
CONCLUSIONS	The findings suggest that a brief IY intervention is a feasible and safe adjunctive treatment for young people with IBS , leading to benefits in a number of IBS-specific and general functioning domains for YA .
CONCLUSIONS	The age-specific results suggest that yoga interventions may be most fruitful when developmentally tailored .

###24590546
OBJECTIVE	The objective of this study was to characterize the pharmacokinetics of 25 , 100 , and 150mg equivalents ( eq . )
OBJECTIVE	of paliperidone long-acting injection in Chinese subjects with schizophrenia .
METHODS	This was an open-label , randomized , parallel group , multicenter study .
METHODS	A total of 48 patients were randomized in a 1:1:1 ratio to one of three groups .
METHODS	Sequential blood samples were collected immediately before injection on day1 and up to 210days after the first injection .
METHODS	The plasma paliperidone concentrations were determined by a validated high-performance liquid chromatography/tandem mass spectrometry method .
RESULTS	A total of 47 patients received at least one injection of the study medication , and 43 completed the study .
RESULTS	The pharmacokinetic ( PK ) parameters , such as time to maximum concentration , t1/2 , and CL/F , were comparable across the three treatment groups ( p = 0.935 , 0.349 , and 0.794 , respectively ) .
RESULTS	The differences in maximum plasma concentration , AUC ( 035days ) , AUC ( 0-210 days ) , and AUC ( 0 - ) were significant ( p < 0.001 ) and dose proportional .
RESULTS	The inter-individual variation of PK parameters was large .
RESULTS	The most frequent treatment-emergent adverse events were prolactin level increasing , injection site pain , tremor , dry mouth , and constipation .
CONCLUSIONS	The pharmacokinetics of paliperidone palmitate are linear with respect to time in Chinese subjects with schizophrenia at injections from 25 to 150mg eq .

###24759796
BACKGROUND	Prasugrel is an antiplatelet agent that shows more prompt , potent , and consistent platelet inhibition than clopidogrel .
BACKGROUND	The objective of this study was to confirm the efficacy and safety of prasugrel at loading/maintenance doses of 20/3 .75 mg .
RESULTS	Japanese patients ( n = 1,363 ) with acute coronary syndrome undergoing percutaneous coronary intervention were randomized to either prasugrel ( 20/3 .75 mg ) or clopidogrel ( 300/75 mg ) , both in combination with aspirin ( 81-330 mg for the first dose and 81-100 mg/day thereafter ) , for 24-48 weeks .
RESULTS	The primary efficacy endpoint was the incidence of major adverse cardiovascular events ( MACE ) at 24 weeks , defined as a composite of cardiovascular death , nonfatal myocardial infarction , and nonfatal ischemic stroke .
RESULTS	We compared the incidence of MACE between the 2 groups using point estimates .
RESULTS	Safety outcomes included the incidence of bleeding events until 2 weeks after the last dose .
RESULTS	The incidence of MACE at 24 weeks was 9.4 % in the prasugrel group and 11.8 % in the clopidogrel group ( risk reduction 23 % , hazard ratio 0.77 , 95 % confidence interval 0.56-1 .07 ) .
RESULTS	The incidence of non-coronary artery bypass graft-related major bleeding was similar in both groups ( 1.9 % vs. 2.2 % ) .
CONCLUSIONS	Prasugrel 20/3 .75 mg was associated with a low incidence of ischemic events , similar to the results of TRITON-TIMI 38 , and with a low risk of clinically serious bleeding in Japanese ACS patients .

###25002178
BACKGROUND	Bivalirudin , with selective use of glycoprotein ( GP ) IIb/IIIa inhibitor agents , is an accepted standard of care in primary percutaneous coronary intervention ( PPCI ) .
BACKGROUND	We aimed to compare antithrombotic therapy with bivalirudin or unfractionated heparin during this procedure .
METHODS	In our open-label , randomised controlled trial , we enrolled consecutive adults scheduled for angiography in the context of a PPCI presentation at Liverpool Heart and Chest Hospital ( Liverpool , UK ) with a strategy of delayed consent .
METHODS	Before angiography , we randomly allocated patients ( 1:1 ; stratified by age [ < 75 years vs 75 years ] and presence of cardiogenic shock [ yes vs no ] ) to heparin ( 70 U/kg ) or bivalirudin ( bolus 075 mg/kg ; infusion 175 mg/kg per h ) .
METHODS	Patients were followed up for 28 days .
METHODS	The primary efficacy outcome was a composite of all-cause mortality , cerebrovascular accident , reinfarction , or unplanned target lesion revascularisation .
METHODS	The primary safety outcome was incidence of major bleeding ( type 3-5 as per Bleeding Academic Research Consortium definitions ) .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01519518 .
RESULTS	Between Feb 7 , 2012 , and Nov 20 , 2013 , 1829 of 1917 patients undergoing emergency angiography at our centre ( representing 97 % of trial-naive presentations ) were randomly allocated treatment , with 1812 included in the final analyses .
RESULTS	751 ( 83 % ) of 905 patients in the bivalirudin group and 740 ( 82 % ) of 907 patients in the heparin group had a percutaneous coronary intervention .
RESULTS	The rate of GP IIb/IIIa inhibitor use was much the same between groups ( 122 patients [ 13 % ] in the bivalirudin group and 140 patients [ 15 % ] in the heparin group ) .
RESULTS	The primary efficacy outcome occurred in 79 ( 87 % ) of 905 patients in the bivalirudin group and 52 ( 57 % ) of 907 patients in the heparin group ( absolute risk difference 30 % ; relative risk [ RR ] 152 , 95 % CI 109-213 , p = 001 ) .
RESULTS	The primary safety outcome occurred in 32 ( 35 % ) of 905 patients in the bivalirudin group and 28 ( 31 % ) of 907 patients in the heparin group ( 04 % ; 115 , 070-189 , p = 059 ) .
CONCLUSIONS	Compared with bivalirudin , heparin reduces the incidence of major adverse ischaemic events in the setting of PPCI , with no increase in bleeding complications .
CONCLUSIONS	Systematic use of heparin rather than bivalirudin would reduce drug costs substantially .
BACKGROUND	Liverpool Heart and Chest Hospital , UK National Institute of Health Research , The Medicines Company , AstraZeneca , The Bentley Drivers Club ( UK ) .

###24659140
BACKGROUND	Partial weight supported treadmill gait training ( PWSTT ) is widely used in rehabilitation of gait in patient with Parkinsons Diseases ( PD ) .
BACKGROUND	However , its effect on blood pressure variability ( BPV ) and baroreflex sensitivity ( BRS ) in PD has not been studied .
OBJECTIVE	To evaluate the effect of conventional and treadmill gait training on BPV components and BRS .
METHODS	Sixty patients with idiopathic PD were randomized into three groups .
METHODS	Twenty patients in control group were on only stable medication , 20 patients in conventional gait training ( CGT ) group ( Stable medication with CGT ) and 20 patients in PWSTT group ( Stable medication with 20 % PWSTT ) .
METHODS	The CGT and PWSTT sessions were given for 30 min per day , 4 days per week , for 4 weeks ( 16 sessions ) .
METHODS	Groups were evaluated in their best ON states .
METHODS	The beat-to-beat finger blood pressure ( BP ) was recorded for 10 min using a Finometer instrument ( Finapres Medical Systems , The Netherlands ) .
METHODS	BPV and BRS results were derived from artifact-free 5-min segments using Nevrocard software .
RESULTS	BRS showed a significant group with time interaction ( F = 6.930 ; p = 0.003 ) .
RESULTS	Post-hoc analysis revealed that PWSTT group showed significant improvement in BRS ( p < 0.001 ) after 4 weeks of training .
RESULTS	No significant differences found in BPV parameters ; systolic BP , diastolic BP , co-variance of systolic BP and low frequency component of systolic BP .
CONCLUSIONS	Four weeks of PWSTT significantly improves BRS in patients with PD .
CONCLUSIONS	It can be considered as a non-invasive method of influencing BRS for prevention of orthostatic BP fall in patients with PD .

###24411226
OBJECTIVE	To determine the impact of late radiation-induced toxicity on health-related quality of life ( HRQoL ) among patients with prostate cancer .
METHODS	The study sample was composed of 227 patients , treated with external beam radiotherapy .
METHODS	Common Terminology Criteria for Adverse Events version 3.0 were used to grade late genitourinary and gastrointestinal toxicity .
METHODS	The European Organization for Research and Treatment of Cancer Quality of life Questionnaire C30 ( EORTC QLQ-C30 ) was used to assess HRQoL at baseline , and 6 , 12 and 24 months after completion of radiotherapy .
METHODS	Statistical analysis was performed using a multivariate analysis of variance ( MANOVA ) .
RESULTS	Urinary incontinence and rectal discomfort significantly affected HRQoL .
RESULTS	The impact of urinary incontinence on HRQoL was most pronounced 6 months after radiotherapy and gradually decreased over time .
RESULTS	The impact of rectal discomfort on HRQoL was predominant at 6 months after radiotherapy , decreased at 12 months and increased again 2 years after radiotherapy .
RESULTS	No significant impact on HRQoL was observed for any of the other toxicity endpoints , or non-toxicity related factors such as hormonal therapy , radiotherapy technique or age .
CONCLUSIONS	Urinary incontinence and rectal discomfort have a significant impact on HRQoL .
CONCLUSIONS	Prevention of these side effects may likely improve quality of life of prostate cancer patients after completion of treatment .

###25936812
OBJECTIVE	The purpose of this single-institution pilot study was to evaluate the feasibility and safety of an oil-based skin agent , Ultra Emu Oil , on skin-related toxicity in patients undergoing radiation therapy to the breast or chest wall .
METHODS	Patients were randomized 2:1 in a double-blind fashion and were instructed to apply processed Ultra Emu Oil or placebo ( cottonseed oil ) twice daily during the course of radiation therapy .
METHODS	The oils were applied before the third fraction and continued for 6 weeks after completion of treatment .
METHODS	The primary endpoint was the area under the curve ( AUC ) of Skindex-16 scale scores over time .
METHODS	Secondary outcomes included maximum grade of radiation dermatitis using the Common Terminology Criteria ( CTC ) for Adverse Events ( CTCAE 3.0 ) , the Skin Toxicity Assessment Tool , quality of life ( QOL ) measured by Linear Analogue Self-Assessment , and a symptom experience diary ( SED ) .
RESULTS	In all , 42 of 45 patients completed the study and were evaluable .
RESULTS	The median times to peak rash , skin redness , peeling , and skin swelling were weeks 6 , 6 , 7 , and 7 , respectively as measured by the SED .
RESULTS	The Skindex AUC scores tended to be lower in emu oil patients than in placebo patients ( mean total AUC 7.2 vs 10.4 , respectively ) .
RESULTS	This trend was also seen in all the Skindex subdomains .
RESULTS	The overall QOL was slightly better in the emu oil group but remained stable throughout the study for both arms .
RESULTS	Peak CTC toxicity occurred at week 6 .
RESULTS	Patients using emu oil appeared slightly worse on maximum CTC grade , but the difference was not significant .
CONCLUSIONS	This pilot study confirmed the safety of oil-based skin treatments during radiation therapy and suggests a trend for reduced skin toxicity for patients receiving emu oil .
CONCLUSIONS	A larger study is needed to evaluate the efficacy of emu oil in reducing radiation dermatitis in patients receiving breast radiation .

###24495781
BACKGROUND	Behavioural lifestyle interventions can be effective at promoting initial weight loss and supporting physical activity and dietary behaviour change , however maintaining improvements in these outcomes is often more difficult to achieve .
BACKGROUND	Extending intervention contact to reinforce learnt behavioural skills has been shown to improve maintenance of behaviour change and weight loss .
BACKGROUND	This trial aims to evaluate the feasibility , acceptability and efficacy of a text message-delivered extended contact intervention to enhance or maintain change in physical activity , dietary behaviour and weight loss among participants who have completed a six month Government-funded , population-based telephone coaching lifestyle program : the Get Healthy Information and Coaching Service ( GHS ) .
METHODS	GHS completers will be randomised to the 6-month extended contact intervention ( Get Healthy , Stay Healthy , GHSH ) or a no contact control group ( standard practice following GHS completion ) .
METHODS	GHSH participants determine the timing and frequency of the text messages ( 3-13 per fortnight ) and content is tailored to their behavioural and weight goals and support preferences .
METHODS	Two telephone tailoring calls are made ( baseline , 12-weeks ) to facilitate message tailoring .
METHODS	Primary outcomes , anthropometric ( body weight and waist circumference via self-report ) and behavioural ( moderate-vigorous physical activity via self-report and accelerometer , fruit and vegetable intake via self-report ) , will be assessed at baseline ( at GHS completion ) , 6-months ( end of extended contact intervention ) and 12-months ( 6-months post intervention contact ) .
METHODS	Secondary aims include evaluation of : the feasibility of program delivery ; the acceptability for participants ; theoretically-guided , potential mediators and moderators of behaviour change ; dose-responsiveness ; and , costs of program delivery .
CONCLUSIONS	Findings from this trial will inform the delivery of the GHS in relation to the maintenance of behaviour change and weight loss , and will contribute to the broader science of text message lifestyle interventions delivered in population health settings .
BACKGROUND	ACTRN12613000949785 .

###24297687
BACKGROUND	Mineralocorticoid receptor antagonists improve outcomes in patients with systolic heart failure but may induce worsening of renal function ( WRF ) and hyperkalemia ( HK ) .
BACKGROUND	We assessed the risk factors for mineralocorticoid receptor antagonist-related WRF and for HK , as well as the association between HK and WRF with clinical outcomes in the Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure ( EMPHASIS-HF ) .
RESULTS	Serial changes in estimated glomerular filtration rate and in serum potassium were available in 2737 patients during a median 21-month follow-up .
RESULTS	HK variably defined as serum K > 4.5 , 5 , or 5.5 mmol/L occurred in 74.7 % , 32.5 % , and 8.9 % patients enrolled in EMPHASIS-HF , respectively .
RESULTS	WRF defined as a decrease in estimated glomerular filtration rate > 20 % or > 30 % from baseline occurred in 27 % and 14 % of patients , respectively .
RESULTS	Patients assigned eplerenone displayed modest and early but significant and persistent ( 1 ) rise in serum potassium and ( 2 ) reduction in estimated glomerular filtration rate when compared with those assigned placebo .
RESULTS	In multivariate analyses , eplerenone was associated with a higher incidence of WRF and HK , which were interrelated and also associated with baseline patient characteristics ( eg , age75 years , hypertension , diabetes mellitus , nonwhite race , ejection fraction < 30 % , and treatment with an antiarrythmics drug or loop diuretic ) .
RESULTS	Eplerenone retained its survival benefits without any significant interaction with the association between HK > 5.5 mmol/L only and WRF and worse outcomes .
CONCLUSIONS	In patients with heart failure receiving optimal therapy , WRF and HK were more frequent when eplerenone was added , but their occurrence did not eliminate the survival benefit of eplerenone .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00232180 .

###24947447
BACKGROUND	Many primary care patients with raised blood pressure or depression drink potentially hazardous levels of alcohol .
BACKGROUND	Brief interventions ( BI ) to reduce alcohol consumption may improve comorbid conditions and reduce the risk of future alcohol problems .
BACKGROUND	However , research has not established their effectiveness in this patient population .
BACKGROUND	This study aimed to establish the feasibility of definitive trials of BI to reduce excessive drinking in primary care patients with hypertension or mild to moderate depression .
METHODS	Thirteen general practices in North East England were randomized to the intervention or control arm of one of two parallel pilot trials .
METHODS	Adult patients drinking excessively and diagnosed with hypertension or mild-to-moderate depression received the Alcohol Use Disorders Identification Test ( AUDIT ) by postal survey .
METHODS	Consenting respondents scoring more than 7 on AUDIT ( score range 0 to 40 ) received brief alcohol consumption advice plus an information leaflet ( intervention ) or an information leaflet alone ( control ) with follow-up at six months .
METHODS	Measurements included the numbers of patients eligible , recruited , and retained , and the AUDIT score and systolic/diastolic blood pressure of each patient or the nine-item Patient Health Questionnaire ( PHQ-9 ) score .
METHODS	Acceptability was assessed via practitioner feedback and patient willingness to be screened , recruited , and retained at follow-up .
RESULTS	In the hypertension trial , 1709 of 33,813 adult patients ( 5.1 % ) were eligible and were surveyed .
RESULTS	Among the eligible patients , 468 ( 27.4 % ) returned questionnaires ; 166 ( 9.6 % of those surveyed ) screened positively on AUDIT and 83 ( 4.8 % of those surveyed ) were recruited ( 50.0 % of positive screens ) .
RESULTS	Sixty-seven cases ( 80.7 % of recruited patients ) completed follow-up at six months .
RESULTS	In the depression trial , 1,044 of 73,146 adult patients ( 1.4 % ) were eligible and surveyed .
RESULTS	Among these eligible patients , 215 ( 20.6 % ) responded ; 104 ( 10.0 % of those surveyed ) screened positively on AUDIT and 29 ( 2.8 % of those surveyed ) were recruited ( 27.9 % of positive screens ) .
RESULTS	Nineteen cases ( 65.5 % of recruited patients ) completed follow-up at six months .
CONCLUSIONS	Recruitment and retention rates were higher in the hypertension trial than in the depression trial .
CONCLUSIONS	A full brief intervention trial appears feasible for primary care patients with hypertension who drink excessively .
CONCLUSIONS	High AUDIT scores in the depression trial suggest the importance of alcohol intervention in this group .
CONCLUSIONS	However , future work may require alternative screening and measurement procedures .
BACKGROUND	Current Controlled Trials ISRCTN89156543 ; registered 21 October 2013 .

###24950218
BACKGROUND	Physicians are expected to serve as role models for healthy lifestyles , but long work hours reduce time for healthy behaviors .
BACKGROUND	A hospital-based physical activity intervention could improve physician health and increase counseling about exercise .
METHODS	We conducted a two-phase intervention among 104 medical residents at a large hospital in Boston , Massachusetts .
METHODS	Phase 1 was a 6-week randomized controlled trial comparing daily steps of residents assigned to an activity monitor displaying feedback about steps and energy consumed ( intervention ) or to a blinded monitor ( control ) .
METHODS	Phase 2 immediately followed and was a 6-week non-randomized team steps competition in which all participants wore monitors with feedback .
METHODS	Phase 1 outcomes were : 1 ) median steps/day and 2 ) proportion of days activity monitor worn .
METHODS	The Phase 2 outcome was mean steps/day on days monitor worn ( 500 steps/day ) .
METHODS	Physiologic measurements were collected at baseline and study end .
METHODS	Median steps/day were compared using Wilcoxon rank-sum tests .
METHODS	Mean steps were compared using repeated measures regression analyses .
RESULTS	In Phase 1 , intervention and control groups had similar activity ( 6369 vs. 6063 steps/day , p = 0.16 ) and compliance with wearing the monitor ( 77 % vs. 77 % of days , p = 0.73 ) .
RESULTS	In Phase 2 ( team competition ) , residents recorded more steps/day than during Phase 1 ( CONTROL : 7,971 vs. 7,567 , p = 0.002 ;
METHODS	7,832 vs. 7,739 , p = 0.13 ) .
METHODS	Mean compliance with wearing the activity monitor decreased for both groups during Phase 2 compared to Phase 1 ( 60 % vs. 77 % , p < 0.001 ) .
METHODS	Mean systolic blood pressure decreased ( p = 0.004 ) and HDL cholesterol increased ( p < 0.001 ) among all participants at end of study compared to baseline .
CONCLUSIONS	Although the activity monitor intervention did not have a major impact on activity or health , the high participation rates of busy residents and modest changes in steps , blood pressure , and HDL suggest that more intensive hospital-based wellness programs have potential for promoting healthier lifestyles among physicians .
BACKGROUND	Clinicaltrials.gov NCT01287208 .

###25992877
BACKGROUND	Postoperative delirium is common in patients recovering from cardiac surgery .
BACKGROUND	Tight glucose control has been shown to reduce mortality and morbidity .
BACKGROUND	Therefore , the authors sought to determine the effect of tight intraoperative glucose control using a hyperinsulinemic-normoglycemic clamp approach on postoperative delirium in patients undergoing cardiac surgery .
METHODS	The authors enrolled 198 adult patients having cardiac surgery in this randomized , double-blind , single-center trial .
METHODS	Patients were randomly assigned to either tight intraoperative glucose control with a hyperinsulinemic-normoglycemic clamp ( target blood glucose , 80 to 110 mg/dl ) or standard therapy ( conventional insulin administration with blood glucose target , < 150 mg/dl ) .
METHODS	Delirium was assessed using a comprehensive delirium battery .
METHODS	The authors considered patients to have experienced postoperative delirium when Confusion Assessment Method testing was positive at any assessment .
METHODS	A positive Confusion Assessment Method was defined by the presence of features 1 ( acute onset and fluctuating course ) and 2 ( inattention ) and either 3 ( disorganized thinking ) or 4 ( altered consciousness ) .
RESULTS	Patients randomized to tight glucose control were more likely to be diagnosed as being delirious than those assigned to routine glucose control ( 26 of 93 vs. 15 of 105 ; relative risk , 1.89 ; 95 % CI , 1.06 to 3.37 ; P = 0.03 ) , after adjusting for preoperative usage of calcium channel blocker and American Society of Anesthesiologist physical status .
RESULTS	Delirium severity , among patients with delirium , was comparable with each glucose management strategy .
CONCLUSIONS	Intraoperative hyperinsulinemic-normoglycemia augments the risk of delirium after cardiac surgery , but not its severity .

###24825868
BACKGROUND	School-aged children suffer high rates of influenza virus infections and associated illnesses each year , and are a major source of transmission in the community .
BACKGROUND	However , information on the cumulative incidence of infection in specific epidemics is scarce , and there are limited studies with sufficient follow-up to identify the strength and duration of protection against reinfection .
METHODS	We randomly allocated children 5-17 years of age to receive trivalent inactivated influenza vaccine ( TIV ) or placebo from September 2009 through January 2010 , and then conducted follow-up for 3 years including regular collection of sera , symptom diaries , and collection of nose and throat swabs during illness episodes in participants or their household members .
RESULTS	Of 796 children initially randomized , 484 continued to participate for all 3 years .
RESULTS	In unvaccinated children , cumulative incidence of infection was estimated to be 59 % in the first wave of H1N1pdm09 in 2009-2010 , and 7 % , 14 % , 20 % , and 31 % in subsequent epidemics of H3N2 ( 2010 ) , H1N1pdm09 ( 2011 ) , B ( 2012 ) , and H3N2 ( 2012 ) , respectively .
RESULTS	Infection with H1N1pdm09 in 2009-2010 and H3N2 in 2010 was associated with protection against infection with subsequent epidemics of the same subtype in 2011 and 2012 , respectively , but we found no evidence of heterotypic or heterosubtypic protection against infection .
CONCLUSIONS	We identified substantial incidence of influenza virus infections in children in Hong Kong in 5 major epidemics over a 3-year period , and evidence of homosubtypic but not heterosubtypic protection following infection .
BACKGROUND	NCT00792051 .

###25694461
OBJECTIVE	To construct and internally validate a risk score , the ' 80 + score ' , for revisits to hospital and mortality for older patients , incorporating aspects of pharmacotherapy .
OBJECTIVE	Our secondary aim was to compare the discriminatory ability of the score with that of three validated tools for measuring inappropriate prescribing : Screening Tool of Older Person 's Prescriptions ( STOPP ) , Screening Tool to Alert doctors to Right Treatment ( START ) and Medication Appropriateness Index ( MAI ) .
METHODS	Two acute internal medicine wards at Uppsala University hospital .
METHODS	Patient data were used from a randomised controlled trial investigating the effects of a comprehensive clinical pharmacist intervention .
METHODS	Data from 368 patients , aged 80years and older , admitted to one of the study wards .
METHODS	Time to rehospitalisation or death during the year after discharge from hospital .
METHODS	Candidate variables were selected among a large number of clinical and drug-specific variables .
METHODS	After a selection process , a score for risk estimation was constructed .
METHODS	The 80 + score was internally validated , and the discriminatory ability of the score and of STOPP , START and MAI was assessed using C-statistics .
RESULTS	Seven variables were selected .
RESULTS	Impaired renal function , pulmonary disease , malignant disease , living in a nursing home , being prescribed an opioid or being prescribed a drug for peptic ulcer or gastroesophageal reflux disease were associated with an increased risk , while being prescribed an antidepressant drug ( tricyclic antidepressants not included ) was linked to a lower risk of the outcome .
RESULTS	These variables made up the components of the 80 + score .
RESULTS	The C-statistics were 0.71 ( 80 + ) , 0.57 ( STOPP ) , 0.54 ( START ) and 0.63 ( MAI ) .
CONCLUSIONS	We developed and internally validated a score for prediction of risk of rehospitalisation and mortality in hospitalised older people .
CONCLUSIONS	The score discriminated risk better than available tools for inappropriate prescribing .
CONCLUSIONS	Pending external validation , this score can aid in clinical identification of high-risk patients and targeting of interventions .

###25695403
BACKGROUND	An antagonist ( MK-7123 ) of the cytokine receptor CXCR2 reduces neutrophil chemotaxis and thus may alleviate airway inflammation in chronic obstructive pulmonary disease ( COPD ) .
OBJECTIVE	To assess the efficacy , safety , and tolerability of three dose levels of MK-7123 , compared with placebo , in patients with moderate to severe COPD .
METHODS	This 6-month , double-blind study randomized patients with moderate to severe COPD ( already on standard therapy ) to daily MK-7123 at 10 , 30 , or 50 mg or placebo .
METHODS	The primary endpoint was change from baseline in post-bronchodilator FEV1 .
RESULTS	A total of 616 patients ( 71 % male ; mean age , 63 yr ; 45 % current smokers ; baseline FEV1 [ SD ] , 1.43 L [ 0.45 ] ; mean FEV1 percent predicted , 43.9 % ) were randomized .
RESULTS	Only MK-7123 50 mg led to significant improvement in FEV1 over placebo ( mean difference [ SE ] , 67 ml [ 32 ] ) .
RESULTS	Reduced sputum neutrophil count was observed among the 122 patients examined ; P = 0.003 ( 3 mo ) and P = 0.092 ( 6 mo ) ( MK-7123 50 mg vs. placebo ) .
RESULTS	The stratum of current smokers , but not that of nonsmokers , showed significant improvement versus placebo in FEV1 ( 168 ml ) and time-to-first exacerbation , and showed numerical improvement in St. George 's Respiratory Questionnaire for COPD score .
RESULTS	MK-7123 caused a dose-dependent decrease in absolute neutrophil count ( ANC ) and reduced inflammatory biomarkers matrix metallopeptidase-9 and myeloperoxidase in plasma and sputum ; ANC lower than 1.510 ( 9 ) / L led to discontinuations with higher doses of MK-7123 ( 18 % in the MK-7123 50-mg group vs. 1 % in placebo ) .
RESULTS	Plasma C-reactive protein and fibrinogen increased with MK-7123 treatment .
RESULTS	Rates of infections at 6 months were similar in all groups .
CONCLUSIONS	Treatment with MK-7123 50 mg versus placebo led to significant improvement in FEV1 in patients with COPD , suggesting clinically important antiinflammatory effects with CXCR2 antagonism , although dose-related discontinuations were observed because of ANC decreases with MK-7123 .
CONCLUSIONS	Greater response was observed in smokers versus ex-smokers .
CONCLUSIONS	Clinical trial registered with www.clinicaltrials.gov ( NCT 01006616 ) .

###25264014
METHODS	Single-blinded randomized controlled pilot study .
OBJECTIVE	To examine the changes in pectoralis minor length ( PML ) , the supine measurement of rounded shoulder posture ( RSP ) , and the total scapular distance ( TSD ) in seated male workers with RSP , after rounded-shoulder-taping ( RST ) using kinesiology tape with ( experimental taping ) and without stretch ( placebo taping ) .
BACKGROUND	RSP , a postural impairment , is a known cause of upper quarter pain .
METHODS	Fourteen men with RSP , who worked for at least 7h/d in a seated position , were selected for RST , with the shoulders randomly assigned to two kinesiology taping methods : ( 1 ) with 35-40 % stretch of its original length ; and ( 2 ) without stretch .
METHODS	The PML , supine measurements of RSP , and TSD , before and after kinesiology taping , with and without stretch , were assessed .
RESULTS	Kinesiology taping with stretch significantly increased the PML and significantly decreased the supine measurement of RSP and TSD ; kinesiology taping without stretch did not increase the PML significantly and did not decrease the supine measurement of RSP and TSD .
CONCLUSIONS	RST using kinesiology tape with stretch produces immediate mechanical correction of RSP in seated male workers .

###25458646
BACKGROUND	Transradial intervention ( TRI ) and bivalirudin infusion compared with transfemoral coronary intervention or unfractionated heparin plus glycoprotein IIb/IIIa inhibitors decrease bleeding complications in patients with acute coronary syndromes ( ACS ) .
BACKGROUND	Although bleeding is thought to be associated with worse outcomes , it remains unclear whether TRI and bivalirudin both independently lower ischemic or combined ischemic and bleeding complications in ACS patients undergoing contemporary invasive management .
OBJECTIVE	The primary objectives of the MATRIX program are to assess whether TRI or bivalirudin as compared , respectively , with transfemoral coronary intervention ( MATRIX access site ) or unfractionated heparin plus provisional glycoprotein IIb/IIIa inhibitors , ( MATRIX antithrombin ) decrease the 30-day incidence of an ischemic ( ie , death , myocardial infarction or stroke ) or an ischemic and bleeding composite end point across the whole spectrum of ACS patients , including clarifying the optimal duration of bivalirudin infusion after percutaneous coronary intervention ( MATRIX treatment duration ) .
METHODS	The MATRIX ( NCT01433627 ) study , which incorporates 3 randomized comparisons in a nonfactorial manner and primary end points at 30 days and clinical follow-up 1 year , is a large-scale , multicenter study with blind event adjudication conducted at approximately 100 European sites .
METHODS	With 8,200 patients in the randomized comparison of access sites and 6,800 individuals participating in the randomized comparison of antithrombin regimens , this study will have 85 % power for the primary end points .
CONCLUSIONS	The MATRIX program aims at conclusively ascertaining the role of TRI and bivalirudin infusion in the whole spectrum of ACS patients undergoing contemporary invasive management .

###24641522
BACKGROUND	A 3-month topical application of clobetasol propionate ( CP ) represents the recommended and accepted first-line treatment for vulvar lichen sclerosus ( VLS ) ; however , to date , no randomized controlled trials have compared the efficacy and safety of CP with other topical corticosteroids .
OBJECTIVE	To compare the effectiveness and tolerability of two different topical corticosteroids , CP 005 % ointment and mometasone furoate ( MMF ) 01 % ointment , in the treatment of VLS .
METHODS	Fifty-four patients with VLS were enrolled in a 12-week active treatment phase ( ATP ) and randomized to apply either CP or MMF in a tapering regimen .
METHODS	The main efficacy parameters were the response rate , the rate of patients achieving an improvement from baseline of 75 % in the subjective and objective scores , and the mean reduction in subjective and objective scores throughout the treatment .
RESULTS	By the end of the 12-week ATP , 24 ( 89 % ) patients were considered to be responders among the CP patients and 24 ( 89 % ) among the MMF patients ; 59 % and 37 % of patients in the CP group and 67 % and 48 % in the MMF group achieved an improvement of at least 75 % in subjective and objective scores , respectively .
RESULTS	The decrease in mean symptom and sign scores was significant compared with baseline with both treatments .
RESULTS	No significant differences were found in any of the assessed efficacy endpoints between CP and MMF .
RESULTS	Both treatments were well tolerated .
CONCLUSIONS	Clobetasol propionate and MMF appeared similarly efficacious and well tolerated for the treatment of VLS and both may represent the first-line treatment for the disease .

###25214041
BACKGROUND	The aim of this study was to analyze the long-term survival of AML patients with CEBPA mutations .
METHODS	We investigated 88 AML patients with a median age of 61years and ( 1 ) cytogenetically normal AML ( CN-AML ) , ( 2 ) monoallelic ( moCEBPA ) or biallelic ( biCEBPA ) CEBPA mutation , and ( 3 ) intensive induction treatment .
METHODS	60/88 patients have been described previously with a shorter follow-up .
RESULTS	Median follow-up time was 9.8 years ( 95 % CI : 9.4-10 .1 years ) compared to 3.2 and 5.2 years in our former analyses .
RESULTS	Patients with biCEBPA mutations survived significantly longer compared to those with moCEBPA ( median overall survival ( OS ) 9.6 years vs. 1.7 years , p = 0.008 ) .
RESULTS	Patients60years and biCEBPA mutations showed a favorable prognosis with a 10-year OS rate of 81 % .
CONCLUSIONS	In this long-term observation we confirmed the favorable prognostic outcome of patients with biCEBPA mutations compared to moCEBPA-mutated CN-AML .
CONCLUSIONS	The high probability of OS ( 81 % ) in younger patients is helpful to guide intensity of postremission therapy .

###25173550
BACKGROUND	A simple approach is the predominant strategy for the percutaneous coronary intervention of bifurcation lesions .
BACKGROUND	Performing side branch ( SB ) predilation in this context is currently a matter of controversy .
BACKGROUND	In this study , we assess the efficacy of SB predilatation before a provisional T-stent strategy for bifurcation lesions .
METHODS	Between February 2009 and November 2012 , 372 patients with true bifurcation lesions were randomized to either predilation of the SB ( n = 187 ) or no predilatation ( n = 185 ) before main branch ( MB ) stent implantation and a subsequent SB provisional stent strategy .
RESULTS	There were no significant differences between the patient groups regarding the baseline characteristics .
RESULTS	After MB stent implantation , the TIMI flow of the SB was higher in the patients with SB predilation : TIMI flow 0 to 1 ; 2 ( 1 % ) versus 18 ( 10 % ) , P < .001 ; and TIMI flow III ; 179 ( 96 % ) versus 152 ( 82 % ) , P < .001 .
RESULTS	Side branch stenting rates were 4 % versus 3 % , P = not significant .
RESULTS	In addition , 60 patients ( 32 % ) from the SB predilation group presented SB residual stenosis by visual inspection < 50 % , and TIMI flow III did not require any additional treatment .
RESULTS	The failure rate of SB rewiring , the time of rewiring , the number of wires used , and the incidence of major events were similar in both groups of patients .
CONCLUSIONS	Predilation of the SB resulted in improved TIMI flow after MB stenting and less indication to subsequently treat the SB .
CONCLUSIONS	If rewiring of the SB is required , predilation did not hinder this maneuver .

###25452054
OBJECTIVE	This study sought to assess the effectiveness of a secondhand tobacco smoke ( SHS ) prevention program based on an expanded Health Belief Model ( HBM ) incorporating self-efficacy among pregnant women in a hospital setting in Taiwan .
METHODS	This study utilized a two-group longitudinal randomized controlled trial design .
METHODS	Participants in the intervention group ( n = 50 ) enrolled in a SHS prevention program based on the HBM , while participants in the comparison group ( n = 50 ) received standard government-mandated counseling care .
METHODS	Both groups were given questionnaires as a pre-test , two weeks into the intervention , and one month following the conclusion of the intervention .
METHODS	The questionnaire and intervention were developed based on the understanding gained through a series of in-depth interviews and a focus-group conducted among pregnant women .
METHODS	Exhaled carbon monoxide was also measured and used as a proxy for SHS exposure .
RESULTS	Intervention group scores were all significantly higher than comparison group scores ( p < 0.001 ) , indicating a significant increase in knowledge , HBM scores , cues to action , self-efficacy , preventative behaviors , and a significant decrease in smoking exposure .
RESULTS	These differences remained significant at the one-month follow-up assessment ( p < 0.001 ) .
CONCLUSIONS	These results should encourage health professionals to educate pregnant women regarding the harms of SHS while both empowering and equipping them with the tools to confront their family members and effectively reduce their SHS exposure while promoting smoke-free social norms .

###24378766
OBJECTIVE	Isoflavones and exercise have been shown to affect C-reactive protein ( CRP ) and body composition and to act synergistically on trunk and total fat mass ( FM ) , glucose metabolism , and lean body mass in postmenopausal women with a body mass index higher than 25 kg/m .
OBJECTIVE	We hypothesized that exercise and isoflavone supplementation ( Ex + ISO ) could reduce inflammation in the same subpopulation of women .
OBJECTIVE	The objective of this study was to investigate if 6 months of mixed exercise combined with isoflavones could have greater effects on specific inflammatory markers than exercise alone in overweight or obese postmenopausal women .
METHODS	Thirty-four postmenopausal women aged 50 to 70 years were randomly assigned to exercise and placebo ( Ex + PLA ; n = 15 ) or Ex + ISO ( n = 19 ) .
METHODS	At baseline and after 6 months , waist circumference , hip circumference , total FM , trunk FM , leg FM , and muscle mass index ( MMI ; = total fat free mass [ kg ] / height [ m ] ) were assessed ( dual-energy x-ray absorptiometry ) .
METHODS	Inflammatory markers ( CRP , tumor necrosis factor - [ TNF - ] , and interleukin-6 ) were obtained by enzyme-linked immunosorbent assay .
METHODS	T tests were used to compare groups at baseline .
RESULTS	The Ex + PLA group showed significant changes in MMI ( +0.33 kg/m , P 0.009 ) and FM compartments ( waist circumference , -5.13 cm ; % FM , -1.31 % ; P 0.001 ) , whereas inflammation remained unchanged .
RESULTS	However , the Ex + ISO group showed significant changes in total FM ( -1.70 kg , P < 0.0001 ) , FM compartments ( hip circumference [ -2.51 cm , P = 0.019 ] , leg FM [ -1.16 kg , P = 0.037 ] , and trunk FM [ -0.72 kg , P = 0.006 ] ) , MMI ( +0.39 kg , P = 0.011 ) , and inflammation ( CRP , -1.14 mg/L , P = 0.029 ; TNF - , +0.29 pg/mL , P = 0.010 ) .
CONCLUSIONS	Despite an increase in TNF - , the use of isoflavones-when body weight remains stable-seems to enhance the beneficial effects of mixed-exercise training on body composition and CRP in overweight or obese postmenopausal women .

###24398734
BACKGROUND	Although feedback conversations are an essential component of learning , three challenges make them difficult : the fear that direct task feedback will harm the relationship with the learner , overcoming faculty cognitive biases that interfere with their eliciting the frames that drive trainees ' performances , and time pressure .
BACKGROUND	Decades of research on developmental conversations suggest solutions to these challenges : hold generous inferences about learners , subject one 's own thinking to test by making it public , and inquire directly about learners ' cognitive frames .
METHODS	The authors conducted a randomized , controlled trial to determine whether a 1-h educational intervention for anesthesia faculty improved feedback quality in a simulated case .
METHODS	The primary outcome was an analysis of the feedback conversation between faculty and a simulated resident ( actor ) by using averages of six elements of a Behaviorally Anchored Rating Scale and an objective structured assessment of feedback .
METHODS	Seventy-one Harvard faculty anesthesiologists from five academic hospitals participated .
RESULTS	The intervention group scored higher when averaging all ratings .
RESULTS	Scores for individual elements showed that the intervention group performed better in maintaining a psychologically safe environment ( 4.3 1.21 vs. 3.8 1.16 ; P = 0.001 ) , identifying and exploring performance gaps ( 4.1 1.38 vs. 3.7 1.34 ; P = 0.048 ) , and they more frequently emphasized the professionalism error of failing to call for help over the clinical topic of anaphylaxis ( 66 vs. 41 % ; P = 0.008 ) .
CONCLUSIONS	Quality of faculty feedback to a simulated resident was improved in the interventional group in a number of areas after a 1-h educational intervention , and this short intervention allowed a group of faculty to overcome enough discomfort in addressing a professionalism lapse to discuss it directly .

###25622243
BACKGROUND	The effect of ibuprofen on pain tolerance during exercise is controversial , and its effects on endurance performance have been poorly investigated .
OBJECTIVE	To investigate the effect of prophylactic administration of the nonsteroidal anti-inflammatory drug ibuprofen on the time until the self-report of fatigue ( tlim ) in runners with exercise-induced muscle damage .
METHODS	Randomized controlled clinical trial .
METHODS	Laboratory .
METHODS	Twenty healthy male long-distance runners ( age = 18.8 0.4 years , maximal oxygen consumption = 55.5 5.9 mLkg ( -1 ) min ( -1 ) ) .
METHODS	Participants were assigned to 2 groups ( ibuprofen group = 10 , placebo group = 10 ) to perform tlim trials ( speed corresponded to their previously determined secondventilatory thresholds ) 48 hours before and 48 hours after the induction of a lower limb muscle-damage protocol ( isokinetic dynamometry ) .
METHODS	One hour before the second tlim trial , the ibuprofen group received 1.2 g ibuprofen , and the placebo group received lactose orally .
METHODS	Time until self-reported fatigue , heart rate , respiratory quotient , oxygen consumption , and perceived exertion were recorded during each tlim test .
RESULTS	Both groups reported increases in muscle pain in the knee extensors and flexors 48 hours after the muscle-damage protocol .
RESULTS	We observed a reduction in the endurance performance of both groups ( P < .01 ) but no difference between groups ( P = .55 ) .
CONCLUSIONS	Ibuprofen did not reduce the effect of muscle damage and pain on performance .
CONCLUSIONS	Prophylactic use of nonsteroidal anti-inflammatory drugs did not have an ergogenic effect on running performance after exercise-induced muscle damage in male long-distance runners .

###24281411
BACKGROUND	Caregivers of people with chronic conditions are more likely than non-caregivers to have depression and emotional problems .
BACKGROUND	Few studies have examined the effectiveness of mindfulness-based stress reduction ( MBSR ) in improving their mental well-being .
METHODS	Caregivers of persons with chronic conditions who scored 7 or above in the Caregiver Strain Index were randomly assigned to the 8-week MBSR group ( n = 70 ) or the self-help control group ( n = 71 ) .
METHODS	Validated instruments were used to assess the changes in depressive and anxiety symptoms , quality of life , self-efficacy , self-compassion and mindfulness .
METHODS	Assessments were conducted at baseline , post-intervention and at the 3-month follow-up .
RESULTS	Compared to the participants in the control group , participants in the MBSR group had a significantly greater decrease in depressive symptoms at post-intervention and at 3 months post-intervention ( p < 0.01 ) .
RESULTS	The improvement in state anxiety symptoms was significantly greater among participants in the MBSR group than those of the control group at post-intervention ( p = 0.007 ) , although this difference was not statistically significant at 3 months post-intervention ( p = 0.084 ) .
RESULTS	There was also a statistically significant larger increase in self-efficacy ( controlling negative thoughts ; p = 0.041 ) and mindfulness ( p = 0.001 ) among participants in the MBSR group at the 3-month follow-up compared to the participants in the control group .
RESULTS	No statistically significant group effects ( MBSR vs. control ) were found in perceived stress , quality of life or self-compassion .
CONCLUSIONS	MBSR appears to be a feasible and acceptable intervention to improve mental health among family caregivers with significant care burden , although further studies that include an active control group are needed to make the findings more conclusive .

###25378424
OBJECTIVE	Pilot studies have suggested benefit from intravenous administration of bone marrow mononuclear stem cells ( BMSCs ) in stroke .
OBJECTIVE	We explored the efficacy and safety of autologous BMSCs in subacute ischemic stroke .
METHODS	This was a phase II , multicenter , parallel group , randomized trial with blinded outcome assessment that included 120 patients .
METHODS	Patients with subacute ischemic stroke were randomly assigned to the arm that received intravenous infusion of autologous BMSCs or to control arm .
METHODS	Coprimary clinical efficacy outcomes were Barthel Index score and modified Rankin scale at day 180 .
METHODS	Secondary outcomes were change in infarct volume , National Institute of Health Stroke Scale ( NIHSS ) at day 90 and 180 .
METHODS	Main safety outcomes were adverse events , any new area of ( 18 ) fluorodeoxyglucose positron emission tomography uptake in any body part over 365 days .
RESULTS	Fifty-eight patients received a mean of 280.75 million BMSCs at median of 18.5 days after stroke onset .
RESULTS	There was no significant difference between BMSCs arm and control arm in the Barthel Index score ( 63.1 versus 63.6 ; P = 0.92 ) , modified Rankin scale shift analysis ( P = 0.53 ) or score > 3 ( 47.5 % versus 49.2 % ; P = 0.85 ) , NIHSS score ( 6.3 versus 7.0 ; P = 0.53 ) , change in infarct volume ( -11.1 versus -7.36 ; P = 0.63 ) at day 180 .
RESULTS	Adverse events were also similar in the 2 arms , and no patient showed any new area of ( 18 ) fluorodeoxyglucose uptake .
CONCLUSIONS	With the methods used , results of this hitherto first randomized controlled trial indicate that intravenous infusion of BMSCs is safe , but there is no beneficial effect of treatment on stroke outcome .
BACKGROUND	URLs : http://ctri.nic.in/Clinicaltrials and http://www.clinicaltrials.gov .
BACKGROUND	Unique identifiers : CTRI-ROVCTRI/2008/091 / 0004 and NCT0150177 .

###24576857
OBJECTIVE	This investigation examined the ergogenic effect of short-term oral N-acetylcysteine ( NAC ) supplementation and the associated changes in redox balance and inflammation during intense training .
METHODS	A double-blind randomized placebo-controlled crossover design was used to assess 9 d of oral NAC supplementation ( 1200 mgd ) in 10 well-trained triathletes .
METHODS	For each supplement trial ( NAC and placebo ) , baseline venous blood and urine samples were taken , and a presupplementation cycle ergometer race simulation was performed .
METHODS	After the loading period , further samples were collected preexercise , postexercise , and 2 and 24 h after the postsupplementation cycle ergometer race simulation .
METHODS	Changes in total antioxidant capacity , ferric reducing ability of plasma , reduced glutathione , oxidized glutathione , thiobarbituric acid-reactive substances , interleukin 6 , xanthine oxidase , hypoxanthine , monocyte chemotactic protein 1 , nuclear factor B , and urinary 15-isoprostane F2t concentration were assessed .
METHODS	The experimental procedure was repeated with the remaining supplement after a 3-wk washout .
METHODS	Eight participants completed both supplementation trials .
RESULTS	NAC improved sprint performance during the cycle ergometer race simulation ( P < 0.001 , p = 0.03 ) .
RESULTS	Supplementation with NAC also augmented postexercise plasma total antioxidant capacity ( P = 0.005 , p = 0.19 ) , reduced exercise-induced oxidative damage ( plasma thiobarbituric acid-reactive substances , P = 0.002 , p = 0.22 ; urinary 15-isoprostane F2t concentration , P = 0.010 , p = 0.431 ) , attenuated inflammation ( plasma interleukin 6 , P = 0.002 , p = 0.22 ; monocyte chemotactic protein 1 , P = 0.012 , p = 0.17 ) , and increased postexercise nuclear factor B activity ( P < 0.001 , p = 0.21 ) .
CONCLUSIONS	Oral NAC supplementation improved cycling performance via an improved redox balance and promoted adaptive processes in well-trained athletes undergoing strenuous physical training .

###25574960
OBJECTIVE	We investigated the prevalence , incidence and predictors of new peripheral neuropathy episodes in previously untreated , symptomatic HIV-infected Ugandan/Zimbabwean adults initiating zidovudine-based antiretroviral therapy ( ART ) .
METHODS	An open-label , multicentre , randomized trial .
METHODS	Peripheral neuropathy was self-reported at 12-weekly clinic visits .
METHODS	Cox regression models ( excluding participants reporting preexisting peripheral neuropathy at ART initiation ) , considered sex ; pre-ART WHO stage , age and CD4 ( + ) cell count ; CD4 ( + ) cell count versus no CD4 ( + ) cell count monitoring ; and time-updated CD4 ( + ) cell count , weight and use of stavudine , isoniazid and didanosine .
RESULTS	Four hundred and twenty-one out of 3316 ( 13 % ) patients reported preexisting peripheral neuropathy at ART initiation .
RESULTS	Median ( interquartile range , IQR ) follow-up in 2895 participants without preexisting peripheral neuropathy was 4.9 ( 4.7-5 .4 ) years .
RESULTS	Three hundred and fifty-four ( 12 % ) took stavudine as first-line substitution and 518 ( 18 % ) took isoniazid during follow-up .
RESULTS	Two hundred and ninety ( 11 % ) participants developed a new peripheral neuropathy episode , an incidence of 2.12 per 100 person-years .
RESULTS	Eighteen ( 0.1 % ) had a grade 3/4 episode .
RESULTS	Independent predictors of peripheral neuropathy were current stavudine use [ adjusted hazard ratio ( a ) HR 4.16 ( 95 % confidence interval , 95 % CI 3.06-5 .66 ] , current isoniazid use [ aHR 1.59 ( 95 % CI 1.02-2 .47 ) ] and current didanosine use [ aHR 1.60 ( 95 % CI 1.19-2 .14 ) ] .
RESULTS	Higher risks were independently associated with higher pre-ART weight [ aHR ( per +5 kg ) 1.07 ( 95 % CI 1.01-1 .13 ) ] and older age aHR ( per 10 years older ) 1.29 ( 95 % CI 1.12-1 .49 ) , but there was no significant effect of sex ( P = 0.13 ) , pre-ART CD4 ( + ) cell count ( P = 0.91 ) or CD4 ( + ) cell count monitoring ( P = 0.73 ) .
CONCLUSIONS	Current stavudine , didanosine or isoniazid use continue to increase peripheral neuropathy risks , as does older age and weight at ART initiation ; however , we found no evidence of increased risk in women in contrast to previous studies .
CONCLUSIONS	The incidence of peripheral neuropathy may now be lower in ART programmes , as stavudine and didanosine are no longer recommended .
CONCLUSIONS	All patients receiving isoniazid , either as part of antituberculosis ( TB ) chemotherapy or TB-preventive therapy , should receive pyridoxine as recommended in national guidelines .

###25322607
OBJECTIVE	To observe the effects of different maintain doses of Dexmedetomidine on plasma cortisol and glucose during anesthesia recovery period in patients undergoing uvulopalatopharyngoplasty under sevoflurane inhalation anesthesia .
METHODS	In this prospective , randomized , double-blind study , 120 ASA I and II patients undergoing selective uvulopalatopharyngoplasty under general anesthesia were included .
METHODS	The patients were randomly allocated to three groups ( n = 40 ) : Dexmedetomidine low maintain dose group ( D1 ) , Dexmedetomidine high maintain dose group ( group D2 ) and control group ( group C ) .
METHODS	The Dexmedetomidine groups and control group were given Dexmedetomidine 1 microg/kg and normal saline in 20 ml within 15 min just before induction of anesthesia .
METHODS	Then Dexmedetomidine were maintained at 0.2 microg x kg ( -1 ) x h ( -1 ) and 0.7 microg x kg ( -1 ) x h ( -1 ) in group D1 and group D2 and were withdrawed 5 min before the end of operation , the same maintained speed of normal saline was given in group C. BIS value was maintained at 40-60 by adjusting the inhaled concentration of sevoflurane .
METHODS	Anesthetic was withdrawed 10 min before the end of operation .
METHODS	Thus , plasma cortisol concentration and blood glucose was needed to be detected just before anesthesia ( T0 ) , tracheal extubation ( T1 ) , 5 min after extubation ( T2 ) and 15 min after extubation ( T3 ) .
METHODS	Duration of operation and anesthesia , consumption of sevoflurane , emergence time , extubation time , the occurrence of dysphoria , bucking and hypoxemia ( SpO2 < 90 % ) during extubation were recorded .
RESULTS	Compared with group C , MAP and HR at T1 , plasma cortisol concentration and blood glucose at T1 - T3 were all significantly lower in group D1 and group D2 ( P < 0.05 ) , and so were the consumption of sevoflurane and the occurrence of dysphoria ( P < 0.05 ) .
RESULTS	The emergence time and extubation time were significantly prolonged in group D2 compared with group D1 and group C ( P < 0.05 ) .
RESULTS	There was no significant difference in the occurrence of bucking and hypoxemia in three groups ( P > 0.05 ) .
CONCLUSIONS	In the patients undergoing UPPP under sevoflurane inhalation anesthesia , Dexmedetomidine infused at 0.2 microg x kg ( -1 ) x h ( -1 ) maintains a stable hemodynamics without respiratory depression , alleviates stress response during extubation and reduces both the consumption of sevoflurane and the occurrence of dysphoria without prolonging emergence time and extubation time .

###25188436
OBJECTIVE	We aimed to identify those patients with hepatitis C virus who benefit most from prophylactic treatment with selective serotonin reuptake inhibitors ( SSRIs ) during antiviral therapy .
METHODS	We performed post hoc analyses on a prospective randomized controlled trial ( n = 79 ) of escitalopram versus placebo during antiviral therapy with pegylated interferon and ribavirin , conducted between August 2005 and June 2008 .
METHODS	Our primary outcome measure was the association of baseline characteristics with the development of depression and/or depressive symptoms .
METHODS	Further , we studied effects of prophylactic escitalopram on depressive symptoms .
METHODS	Presence of a major depression was diagnosed using Mini-International Neuropsychiatric Interview ( MINI ) , a short , structured interview used to diagnose DSM-IV-TR and ICD-10 disorders .
METHODS	Depressive symptoms were monitored during treatment by using the depression scale of Symptom Checklist-90 ( SCL-90 ) , Montgomery-Asberg Depression Rating Scale ( MADRS ) , and Beck Depression Inventory ( BDI ) at baseline and weeks 4 , 12 , and 24 of antiviral therapy .
RESULTS	Depression occurred in 14 patients receiving placebo and in 5 patients receiving escitalopram ( Pearson , P = .01 ) .
RESULTS	Combination of history of depression and intravenous drug use was associated with depression ( odds ratio = 12.60 ; 95 % CI , 2.47-64 .34 ; P < .01 ) .
RESULTS	Moreover , treatment with selective serotonin reuptake inhibitor compared to placebo was associated with a significant reduction in estimated mean depressive symptoms measured by SCL-90 ( P = .03 ) and BDI ( P = .048 ) , but not with MADRS ( P = .64 ) .
CONCLUSIONS	Patients infected by hepatitis C virus with a history of depression and intravenous drug use carry the highest risk to develop interferon-induced depression .
CONCLUSIONS	In this subset of patients , prophylaxis with escitalopram results in the most substantial decrease of interferon-induced depressive symptoms on the SCL-90 depression scale and the BDI .

###25607608
BACKGROUND	One in 4 men in the United States aged > 50 years will have an osteoporosis-related fracture .
BACKGROUND	Fewer data are available on osteoporosis treatment in men than in women .
OBJECTIVE	The purpose of this study was to evaluate denosumab therapy in men with low bone mineral density ( BMD ) .
METHODS	This was a phase 3 study with 2 treatment periods : a previously reported 12-month double-blind , placebo-controlled phase and a 12-month open-label phase .
METHODS	This was a multicenter study conducted in North America and Europe .
METHODS	A total of 228 men entered the open-label phase and 219 completed the study .
METHODS	Men from the original denosumab ( long-term ) and placebo ( crossover ) groups received 60 mg of denosumab sc every 6 months .
METHODS	BMD , serum collagen type I C-telopeptide , and safety were measured .
RESULTS	During the open-label phase , continued BMD increases occurred with long-term denosumab treatment ( 2.2 % lumbar spine , 0.9 % total hip , 1.3 % femoral neck , 1.3 % trochanter , and 0.2 % 1/3 radius ) , resulting in cumulative 24-month gains from baseline of 8.0 % , 3.4 % , 3.4 % , 4.6 % , and 0.7 % , respectively ( all P < .01 ) .
RESULTS	The crossover group showed BMD gains after 12 months of denosumab treatment similar to those of the long-term denosumab group during the first treatment year .
RESULTS	Significant reductions in serum collagen type I C-teleopeptide were observed after denosumab administration .
RESULTS	Adverse event rates were similar between groups , and no new safety signals were identified .
CONCLUSIONS	In men with low BMD , denosumab treatment for a second year continued to increase BMD , maintained reductions in bone resorption , and was well tolerated .
CONCLUSIONS	BMD increased in men initiating denosumab during the second year .
CONCLUSIONS	These effects were similar to those previously seen in postmenopausal women with osteoporosis and in men with prostate cancer receiving androgen deprivation therapy .

###24731899
OBJECTIVE	Our recent pilot study demonstrated mindfulness-based cognitive therapy ( MBCT ) is a potentially efficacious headache pain treatment ; however , it was not universally effective for all participants .
OBJECTIVE	This study sought to explore patient characteristics associated with MBCT treatment response and the potential processes of change that allowed treatment responders to improve and that were potentially lacking in the non-responders .
METHODS	We implemented a mixed-methods analysis of quantitative and qualitative data .
METHODS	The sample consisted of 21 participants , 14 of whom were classified as treatment responders ( 50 % improvement in pain intensity and/or pain interference ) and seven as non-responders ( < 50 % improvement ) .
METHODS	The study was conducted at the Kilgo Headache Clinic and the University of Alabama Psychology Clinic .
METHODS	Participants completed an 8-week MBCT treatment for headache pain management .
METHODS	Standardized measures of pain , psychosocial outcomes , and non-specific therapy factors were obtained ; all participants completed a post-treatment semi-structured interview .
RESULTS	Quantitative data indicated a large effect size difference between responders and non-responders for pre - to post-treatment change in standardized measures of pain acceptance and catastrophizing , and a small to medium effect size differences on treatment dose indicators .
RESULTS	Both groups showed improved psychosocial outcomes .
RESULTS	Qualitatively , change in cognitive processes was a more salient qualitative theme within treatment responders ; both groups commented on the importance of non-specific therapeutic factors .
RESULTS	Barriers to mindfulness meditation were also commented on by participants across groups .
CONCLUSIONS	Results indicated that change in pain related cognitions during an MBCT intervention for headache pain is a key factor underlying treatment response .

###24814592
BACKGROUND	Many stroke survivors would benefit from modification of their lifestyle in order to reduce their risk of recurrent stroke .
BACKGROUND	We investigated if tailored smoking cessation advice would yield a higher smoking cessation rate and a higher rate with sustained abstinence in ex-smokers in the intervention group than among controls .
METHODS	Patients admitted with an acute stroke or a transient ischaemic attack were included in a randomised controlled trial focusing on control of lifestyle risk factors and hypertension .
METHODS	Here , we report the intervention focused on smoking cessation .
METHODS	We used multiple logistic regression analysis to identify patient characteristics associated with smoking cessation .
METHODS	Analyses were by intention to treat excluding those who died or suffered severe disease .
RESULTS	We included 254 patients with a history of smoking .
RESULTS	Two years after inclusion , 15 of 57 ( 26 % ) baseline smokers in the intervention group had stopped smoking versus eight of 56 ( 14 % ) among controls ( p = 0.112 ) .
RESULTS	Living with a partner ( p = 0.012 ) , having at least ten years of education ( p = 0.012 ) , and not being exposed to smoking at home ( p = 0.036 ) were independent predictors of smoking cessation .
CONCLUSIONS	We did not achieve our aim of higher smoking cessation rates in the intervention group .
CONCLUSIONS	Future smoking cessation interventions should be more intensive , focus on patients ' social circumstances and , if possible , involve patients ' relatives .
BACKGROUND	This study was supported by the Ludvig and Sara Elsass Foundation , the Lundbeck Foundation and The Danish Heart Foundation ( Grant 07-4-B703-A1378-22384F ) .
BACKGROUND	This protocol is registered with Clinical Trials.gov ( NCT 00253097 ) .

###25428346
OBJECTIVE	To test the hypothesis that promoting breakfast cereal consumption , as part of a web-based programme , results in loss of body mass .
METHODS	Single centre , single blind , randomised parallel study .
METHODS	Test group followed a fully interactive website ( B ) with ` prescribed ' breakfast cereals .
METHODS	Control group followed website ( A ) giving standard advice on weight loss.Study site visits at 0 , 4 , 12 and 24 weeks for measurements of height , weight , skinfolds , body fat , waist and hip circumference .
METHODS	180 subjects were randomly allocated to two equal groups.Subjects were in good health and aged 1950 years , with a BMI ranging from 2540 kg/m 2 .
METHODS	At baseline there was no difference in mean age or BMI between the two groups .
RESULTS	The percentage change in body mass loss was greater when following website B than website A ( n = 90 ; ITT repeated measures p = 0.013 ) .
RESULTS	For completers ( website A : n = 62 , website B : n = 64 ) , the percentage change in body mass loss was also greater for website B than website A ( repeated measures p = 0.023 ) .
CONCLUSIONS	The advice and motivation offered by an interactive website , including provision and consumption of breakfast cereals , results in significantly greater loss of body mass compared to the use of a standard website .
CONCLUSIONS	It is not possible to discern which of the three factors is responsible .

###24237386
OBJECTIVE	This randomized , double-blind , placebo-controlled parallel-group study assessed the effects of sodium glucose cotransporter 2 inhibition by dapagliflozin on insulin sensitivity and secretion in subjects with type 2 diabetes mellitus ( T2DM ) , who had inadequate glycemic control with metformin ( with or without an insulin secretagogue ) .
METHODS	Forty-four subjects were randomized to receive dapagliflozin 5 mg or matching placebo once daily for 12 weeks .
METHODS	Subjects continued stable doses of background antidiabetes medication throughout the study .
METHODS	Insulin sensitivity was assessed by measuring the glucose disappearance rate ( GDR ) during the last 40 min of a 5-h hyperinsulinemic , euglycemic clamp .
METHODS	Insulin secretion was determined as the acute insulin response to glucose ( AIRg ) during the first 10 min of a frequently sampled intravenous glucose tolerance test .
METHODS	Where noted , data were adjusted for baseline values and background antidiabetes medication .
RESULTS	An adjusted mean increase from baseline in GDR ( last observation carried forward ) , at Week 12 , was observed with dapagliflozin ( 7.98 % ) versus a decrease with placebo ( -9.99 % ) .
RESULTS	The 19.97 % ( 95 % confidence interval 5.75-36 .10 ) difference in GDR versus placebo was statistically significant ( P = 0.0059 ) .
RESULTS	A change from baseline in adjusted mean AIRg of 15.39 mU/L min was observed with dapagliflozin at Week 12 , versus -12.73 mU/L min with placebo ( P = 0.0598 ) .
RESULTS	Over 12 weeks , numerical reductions from baseline in glycosylated hemoglobin ( HbA1c ) , fasting plasma glucose , and body weight were observed with dapagliflozin ( -0.38 % , -0.39 mmol/L , and -1.58 % , respectively ) versus slight numerical increases with placebo ( 0.03 % , 0.26 mmol/L , and 0.62 % , respectively ) .
CONCLUSIONS	In patients with T2DM and inadequate glycemic control , dapagliflozin treatment improved insulin sensitivity in the setting of reductions in HbA1c and weight .

###25880964
OBJECTIVE	We examined the causes of hospitalization and death of people who inject drugs participating in the Bangkok Tenofovir Study , an HIV preexposure prophylaxis trial .
METHODS	The Bangkok Tenofovir Study was a randomized , double-blind , placebo-controlled trial conducted during 2005 to 2012 among 2413 people who inject drugs .
METHODS	We reviewed medical records to define the causes of hospitalization and death , examined participant characteristics and risk behaviors to determine predictors of death , and compared the participant mortality rate with the rate of the general population of Bangkok , Thailand .
RESULTS	Participants were followed an average of 4 years ; 107 died : 22 ( 20.6 % ) from overdose , 13 ( 12.2 % ) from traffic accidents , and 12 ( 11.2 % ) from sepsis .
RESULTS	In multivariable analysis , older age ( 40-59 years ; P = .001 ) , injecting drugs ( P = .03 ) , and injecting midazolam ( P < .001 ) were associated with death .
RESULTS	The standardized mortality ratio was 2.9 .
CONCLUSIONS	People who injected drugs were nearly 3 times as likely to die as were those in the general population of Bangkok and injecting midazolam was independently associated with death .
CONCLUSIONS	Drug overdose and traffic accidents were the most common causes of death , and their prevention should be public health priorities .

###25889758
BACKGROUND	We aimed to explore the influence of a motivationally-enhanced instructional design on motivation to learn and knowledge , hypothesizing that outcomes would be higher for the enhanced instructional format .
METHODS	Medicine residents completed four online learning modules on primary care topics .
METHODS	Using a crossover design , learners were randomized to receive two standard and two motivationally-enhanced learning modules .
METHODS	Both formats had self-assessment questions , but the enhanced format questions were framed to place learners in a supervisory/teaching role .
METHODS	Learners received a baseline motivation questionnaire , a short motivation survey before and after each module , and a knowledge posttest .
RESULTS	One hundred twenty seven residents were randomized .
RESULTS	123 residents ( 97 % ) completed at least one knowledge posttest and 119 ( 94 % ) completed all four posttests .
RESULTS	Across all modules , a one-point increase in the pretest short motivation survey was associated with a 2.1-point increase in posttest knowledge .
RESULTS	The change in motivation was significantly higher for the motivationally enhanced format ( standard mean change -0.01 , enhanced mean change +0.09 , difference = 0.10 , CI 0.001 to 0.19 ; p = 0.048 ) .
RESULTS	Mean posttest knowledge score was similar ( standard mean 72.8 , enhanced mean 73.0 , difference = 0.2 , CI -1.9 to 2.1 ; p = 0.90 ) .
CONCLUSIONS	The motivationally enhanced instructional format improved motivation more than the standard format , but impact on knowledge scores was small and not statistically significant .
CONCLUSIONS	Learners with higher pre-intervention motivation scored better on post-intervention knowledge tests , suggesting that motivation may prove a viable target for future instructional enhancements .

###25434409
OBJECTIVE	To study the effects of a health check by a nurse alone or combined with an exercise intervention in middle-aged men at increased cardiovascular risk .
METHODS	A randomized controlled trial .
METHODS	Primary care in Kirkkonummi municipality with 36 000 inhabitants .
METHODS	A health check by a nurse alone or combined with an exercise intervention to controls with no intervention was compared .
METHODS	A total of 168 men aged 35 to 45 years with at least two cardiovascular risk factors and physical activity ( PA ) frequency < 3 times a week .
METHODS	Metabolic syndrome ( MetS ) as defined by International Diabetes Federation/American Heart Association and self-reported PA frequency .
RESULTS	Overall , focusing on health increased physical activity frequency in middle-aged men .
RESULTS	After one year , 19 % had increased PA to 3 times a week ( 95 % CI 12-26 ) .
RESULTS	All study groups increased PA to 3 times : 26 % of men in the exercise intervention group , 15 % of men in the health check group , and 16 % of controls .
RESULTS	The differences between the groups were not statistically significant .
RESULTS	The intervention did not have any meaningful impact on MetS or other cardiovascular outcomes at one-year follow up .
CONCLUSIONS	Physical activity increased in all study groups of middle-aged men in this health-promotion trial .
CONCLUSIONS	The interventions had no effect on metabolic syndrome or other cardiovascular outcomes in the participants .
CONCLUSIONS	The trial increased awareness and collaboration in physical activity promotion among municipal health care and exercise services .

###24433126
BACKGROUND	Vegetable consumption among preschool children is below recommended levels .
BACKGROUND	New evidence-based approaches to increase preschoolers ' vegetable intake , particularly in the child care setting , are needed .
BACKGROUND	This study tests the effectiveness of two community-based randomized interventions to increase vegetable consumption and willingness to try vegetables : ( 1 ) the pairing of a vegetable with a familiar , well-liked food and ( 2 ) enhancing the visual appeal of a vegetable .
METHODS	Fifty-seven preschoolers enrolled in a Child and Adult Care Food Program-participating child care center participated in the study ; complete lunch and snack data were collected from 43 and 42 children , respectively .
METHODS	A within-subjects , randomized design was used , with order of condition counterbalanced .
METHODS	For lunch , steamed broccoli was served either on the side of or on top of cheese pizza .
METHODS	For a snack , raw cucumber was served either as semicircles with chive and an olive garnish or arranged in a visually appealing manner ( in the shape of a caterpillar ) .
METHODS	Paired t-tests were used to determine differences in consumption of meal components , and McNemar 's test was performed to compare willingness to taste .
RESULTS	Neither visual appeal enhancement nor pairing with a liked food increased vegetable consumption .
RESULTS	Pairing increased willingness to try the vegetable from 79 % to 95 % of children ( p = 0.07 ) .
RESULTS	Greater vegetable intake occurred at snack than at lunch .
CONCLUSIONS	Further research should explore the strategy of pairing vegetables with liked foods .
CONCLUSIONS	Greater consumption at snack underscores snack time as a critical opportunity for increasing preschool children 's vegetable intake .

###25022119
OBJECTIVE	To compare the difference in the clinical efficacy on cervical spondylosis of vertebral artery type ( CSA ) treated with thermosensitive moxibustion at different dosages .
METHODS	Sixty cases of CSA were randomized into a saturated moxa dosage group and a regular moxa dosage group , 30 cases in each one .
METHODS	The thermosensitive moxibustion was adopted in the two groups .
METHODS	The mild suspended moxibustion was applied at two acupoints with the strongest thermosensitization .
METHODS	In the saturated moxa dosage group , the moxibustion time was determined by the disappearance of thermosensitization .
METHODS	In the regular moxa dosage group , 15 min was required on each acupoint .
METHODS	The treatment was given twice a day for first 4 days in the two groups .
METHODS	Since the 5th day , the treatment was given once a day , continuously for 10 times , and totally 14 days were required .
METHODS	The score of symptoms and function and clinical efficacy were compared between the two groups before and after treatment as well as 6-month follow-up after treatment .
RESULTS	The curative and effective rate was 56.7 % ( 17/30 ) after treatment and 60.0 % ( 18/30 ) in 6-month follow-up after treatment in the saturated moxa dosage group , which were superior to 26.7 % ( 8/30 ) and 30.0 % ( 9/30 ) in the regular moxa dosage group respectively ( P < 0.01 , P < 0.05 ) .
RESULTS	The scores of clinical symptoms and function after treatment and in follow-up were improved apparently as compared with those before treatment in both groups ( all P < 0.01 ) .
RESULTS	The scores of clinical symptoms and function after treatment and in follow-up in the saturated moxa dosage group were increased much more apparently than those in the regular moxa dosage group ( after treatment : 22.32 + / - 4.64 vs 17.43 + / - 3.21 ; in follow-up : 23.01 + / - 4.76 vs 18.32 + / - 2.13 , both P < 0.01 ) .
CONCLUSIONS	The thermosensitization moxibustion of saturated dosage achieves the superior short-term and long-term efficacies in the treatment of CSA as compared with the regular moxibustion dosage .

###24514432
OBJECTIVE	To investigate changes in standard base excess ( SBE ) when administering two different infusion regimens for elective hip replacement within a goal-directed haemodynamic algorithm .
METHODS	This prospective , double-blind , randomized , controlled study enrolled patients scheduled for primary hip replacement surgery , who were randomized to receive either an unbalanced crystalloid ( chloride : 155.5 mmol/l ) or a 1 : 1 mixture of a balanced crystalloid and a balanced colloid ( 6 % w/v hydroxyethyl starch 130/0 .42 ; chloride : 98 and 112 mmol/l , respectively ) .
METHODS	Fluid management was goal-directed to optimize stroke volume using oesophageal Doppler .
RESULTS	A total of 40 patients ( 19 female/21 male ) participated in the study .
RESULTS	After surgery , median ( 25-75 % percentiles ) SBE was significantly lower in the unbalanced group compared with the balanced group : -2.0 mmol/l ( -3.1 to -1.1 ) versus -0.4 mmol/l ( -1.2 to 0.7 ) , respectively .
RESULTS	This difference was mainly due to greater plasma chloride concentrations in the unbalanced group .
RESULTS	The amount of study medication required to reach haemodynamic stability ( median 1200 ml ) did not differ between the two groups .
CONCLUSIONS	SBE decreased in the unbalanced group without influence on fluid requirements and haemodynamic stability .

###24559212
BACKGROUND	Bacterial resistance development is one of the most urgent problems in healthcare worldwide .
BACKGROUND	In Europe , dentistry accounts for a comparatively high amount of antibiotic prescriptions .
BACKGROUND	In light of increasing levels of bacterial resistance , this development is alarming .
BACKGROUND	So far , very few interventional studies have been performed , and further research is urgently needed .
BACKGROUND	By means of a complex educational intervention , the DREAM trial aims at optimising antibiotic prescribing behaviour of general dentists in Germany .
METHODS	This is a cluster-randomised controlled trial , where each cluster consists of one dental practice and all of its patients in a defined period .
METHODS	Participants are general dentists practicing in the German region of Mecklenburg-Western Pomerania .
METHODS	Randomisation takes place after baseline data collection ( 6months ) and will be stratified by the antibiotic prescribing rates of the participating dental practices .
METHODS	Dentists randomised into the intervention group will participate in a complex small group educational seminar that aims at : increasing knowledge on bacterial resistance , pharmacology , and prophylaxis of infectious endocarditis ; increasing awareness of dentist-patient communication using video-taped vignettes of dentist-patient communication on antibiotic treatment ; improving collaboration between general dentists , general practitioners , and practice-based cardiologists on the necessity of antibiotic prophylaxis ; enhancing awareness of the dentists ' own prescribing habits by providing antibiotic prescribing feedback ; and increasing patient knowledge on antibiotic treatment by providing patient-centred information material on antibiotic prophylaxis of endocarditis .
METHODS	The dentists randomised into the control group will not receive any educational programme and provide care as usual .
METHODS	Primary outcome is the overall antibiotic prescribing rate measured at T1 ( period of six months after intervention ) .
METHODS	In a subgroup of adult patients affected by odontogenic infections , microbiological analyses for antibiotic resistance of oral streptococci are performed .
CONCLUSIONS	Major aim of the study is to improve the process of decision making with regard to antibiotic prescribing .
CONCLUSIONS	The approach is simple to implement and might be used rapidly in graduate and post-graduate medical education .
CONCLUSIONS	We expect the results of this trial to have a major impact on antibiotic prescription strategies and practices in Germany .
BACKGROUND	Current Controlled Trials ISRCTN09576376 .

###25572008
BACKGROUND	Renal impairment in cancer patients can affect treatment tolerability and outcomes .
BACKGROUND	This analysis evaluated the safety and efficacy of nab-paclitaxel ( nab-P ) versus solvent-based paclitaxel ( sb-P ) , both in combination with carboplatin ( C ) , in patients with advanced non-small-cell lung cancer ( NSCLC ) and renal impairment .
METHODS	Untreated patients with stage IIIB/IV disease with NSCLC and a performance status of 0/1 were randomly assigned ( 1:1 ) to receive 100 mg/m ( 2 ) nab-P weekly plus C ( under the curve = 6 , every 3 weeks ) or 200 mg/m ( 2 ) sb-P plus C ( under the curve = 6 ) every 3 weeks .
METHODS	The primary end point was overall response rate .
RESULTS	Of 1038 treated patients in the phase III trial , 38 % had mild renal impairment ( creatinine clearance > 50 to 80 mL/min ; n = 198 for nab-P/C and n = 206 for sb-P/C ) and 5 % had moderate renal impairment ( creatinine clearance 50 mL/min : n = 26 for nab-P/C and n = 27 for sb-P/C ) .
RESULTS	For nab-P/C versus sb-P/C , the treatment difference in efficacy in patients with either level of renal impairment was comparable to the overall population but did not reach statistical significance , with an overall response rate of 35 % versus 27 % ( response rate ratio , 1.324 ; P = .060 ) in patients with mild renal impairment , and 31 % versus 19 % ( response rate ratio , 1.662 ; P = .300 ) in patients with moderate renal impairment .
RESULTS	Overall survival and progression-free survival were nonsignificantly longer for nab-P/C versus sb-P/C in these subsets .
RESULTS	Patients with renal impairment experienced less grade 3 or higher neutropenia and sensory neuropathy , but more thrombocytopenia and anemia with nab-P/C versus sb-P/C .
CONCLUSIONS	nab-P/C proved beneficial and tolerable in patients with advanced NSCLC and mild and moderate renal impairment .

###24372992
OBJECTIVE	The effect of aspirin upon platelet function is well documented although experimental studies suggest that aspirin may also affect oxidative stress , vascular inflammation , endothelial dysfunction and dysglycaemia .
OBJECTIVE	The optimal dose of aspirin for cardiovascular protection in type 2 diabetes is still debated .
OBJECTIVE	We examined the effects of different doses of aspirin upon these novel markers of cardiovascular risk and any association between aspirin-mediated changes in these markers .
METHODS	Subjects with type 2 diabetes attended for baseline evaluation including BMI , glycaemic and lipid markers , endothelial function ( photoplethysmography ) , insulin resistance ( HOMA ) , inflammation ( sVCAM-1 and Hs-CRP ) and markers of oxidative stress [ total anti-oxidant status ( TAOS and FRAP ) , whole blood total glutathione ( GSH ) assays ] .
METHODS	Subjects then received in random , sequential , blinded fashion aspirin 75 mg day ( -1 ) , aspirin 300 mg day ( -1 ) , aspirin 3.6 g day ( -1 ) or placebo for 2 weeks with a 2-week washout .
METHODS	The above investigations were repeated after each intervention .
METHODS	Aspirin-related changes compared with placebo were analysed using repeated measures ANOVA .
RESULTS	Subjects = 17 ( M - 12 ; F - 5 ) , mean age - 57.4 9.1 years ( mean 1 SD ) , HbA1c - 63 13 mmol mol ( -1 ) ( 7.9 1.2 % ) , total cholesterol 4.57 1.01 mmol l ( -1 ) .
RESULTS	At baseline TAOS value was 59.3 9.7 M AEAC ( Ascorbate Equivalent Anti-oxidant Concentration ) , glutathione 302.2 183.3 mmol l ( -1 ) and FRAP 0.86 0.23 mM FeII .
RESULTS	None of the aspirin doses had a significant impact upon BMI , blood pressure , lipid parameters , insulin sensitivity ( HOMA ) , FRAP , TAOS , GSH , endothelial function , glycaemic control ( fructosamine ) or inflammation ( sVCAM-1 and HsCRP ) .
CONCLUSIONS	Aspirin exhibited no significant dose-dependent effect on markers of vascular inflammation , oxidative stress , insulin resistance and endothelial function ( photoplethysmography ) when used in type 2 diabetes over a 2-week period .
BACKGROUND	NCT00898950 , EUDRACT :2004 -001418 -14 ) .

###24251826
BACKGROUND	Acetazolamide has been used to attenuate Hunter-Cheyne-Stokes breathing with central sleep apnea ( CSA ) associated with heart failure .
BACKGROUND	However , the mechanisms underlying this improvement remain to be fully elucidated .
OBJECTIVE	We hypothesized that acetazolamide stabilizes CSA by attenuating the ventilatory sensitivity to CO2 , which is increased in patients with heart failure and is thought to be the major mechanism mediating CSA .
METHODS	Six consecutive male patients with stable systolic heart failure and CSA ( apnea-hypopnea index [ AHI ] 15 episodes/h ) were randomized to a double-blind crossover protocol with acetazolamide or placebo received 1 hour before bedtime for six nights with 2 weeks of wash-out .
METHODS	Under both conditions , we measured the hypercapnic ventilatory response ( HCVR ) , arterial blood Pco2 , steady-state metabolic CO2 production , overnight attended polysomnography , and also assessed cardiac and pulmonary function .
RESULTS	Compared with placebo , acetazolamide significantly decreased the AHI ( 65 32 vs. 31 19 events/h , mean SD ) .
RESULTS	Acetazolamide increased the HCVR slope by 55 % ( 3.3 1.7 vs. 5.1 2.4 L/min/mm Hg ; P = 0.03 ) , an increase that far exceeded the 12 % fall in arterial Pco2 ( P = 0.02 ) .
RESULTS	The acetazolamide-induced change in the balance of these effects ( HCVR Pco2 ) was inversely associated with the reduction in AHI ( r = 0.8 ; P = 0.045 ) .
CONCLUSIONS	This placebo-controlled study indicates that acetazolamide improves CSA in patients with heart failure despite an increase in the slope of the HCVR .
CONCLUSIONS	However , because the degree of HCVR elevation inhibits the improvement in unstable breathing , an increased CO2 chemosensitivity may be a key mechanism underlying an incomplete resolution of CSA with acetazolamide .

###24879050
BACKGROUND	The Medicare Accountable Care Organization ( ACO ) programs encourage integration of providers into large groups and reward provider groups for improving quality , but not explicitly for reducing health care disparities .
BACKGROUND	Larger group size and better overall quality may or may not be associated with smaller disparities .
OBJECTIVE	To examine differences in patient characteristics between provider groups sufficiently large to participate in ACO programs and smaller groups ; the association between group size and racial disparities in quality ; and the association between quality and disparities among larger groups .
METHODS	Using 2009 Medicare claims for 3.1 million beneficiaries with cardiovascular disease or diabetes and linked data on provider groups , we compared racial differences in quality by provider group size , adjusting for patient characteristics .
METHODS	Among larger groups , we used multilevel models to estimate correlations between group performance on quality measures for white beneficiaries and black-white disparities within groups .
METHODS	Four process measures of quality , hospitalization for ambulatory care-sensitive conditions ( ACSCs ) related to cardiovascular disease or diabetes , and hospitalization for any ACSC .
RESULTS	Beneficiaries served by larger groups were more likely to be white and live in areas with less poverty and more education .
RESULTS	Larger group size was associated with smaller disparities in low-density lipoprotein ( LDL ) cholesterol testing and retinal exams , but not in other process measures or hospitalization for ACSCs .
RESULTS	Among larger groups , better quality for white beneficiaries in one measure ( hospitalization for ACSCs related to cardiovascular disease or diabetes ) was correlated with smaller racial disparities ( r = 0.28 ; P = 0.02 ) , but quality was not correlated with disparities in other measures .
CONCLUSIONS	Larger provider group size and better performance on quality measures were not consistently associated with smaller racial disparities in care for Medicare beneficiaries with cardiovascular disease or diabetes .
CONCLUSIONS	ACO incentives rewarding better quality for minority groups and payment arrangements supporting ACO development in disadvantaged communities may be required for ACOs to promote greater equity in care .

###24260516
BACKGROUND	Our study aims to evaluate the image quality and feasibility of 128-slice dual-energy CTA ( DE-CTA ) for supra-aortic arteries using reduced amounts of contrast medium ( CM ) .
METHODS	A prospective study was performed in 54 patients receiving CTA of the head and neck with a 128-slice dual-source CT system .
METHODS	Patients were randomized into two groups with a volume of either 40 mL of CM ( Group I ) or 50 mL of CM ( Group II ) .
METHODS	Arterial and venous enhancements were recorded for quantitative assessment .
METHODS	Qualitative assessments for images without bone removal ( BR ) were based on a ) the visualization of the circle of Willis and b ) streak artifacts due to residual CM in the subclavian or internal jugular veins ipsilateral to injection of CM .
METHODS	Qualitative assessment of dual-energy images using BR was based on the presence of bone remnants and vessel integrity .
METHODS	Quantitative data was compared using the Student t test .
METHODS	The ( 2 ) test was used for the qualitative measurements of streak artifacts in veins while the Mann-Whitney U test was used for the qualitative measurements of images with BR .
RESULTS	Arterial and venous attenuation was significantly higher in Group II ( P = 0.000 ) .
RESULTS	Image quality regarding the circle of Willis was excellent in both groups ( 3.900.30 for Group I and 4.000 for Group II ) .
RESULTS	Imaging of the internal jugular veins was scored higher in Group I ( 1.870.72 ) compared with Group II ( 1.480.51 ) ( P = 0.021 ) .
RESULTS	Within Group I using BR , mean scores for bone remnants did not differ significantly ( P > 0.05 ) but mean scores of vessel integrity ( P < 0.05 ) did .
CONCLUSIONS	Contrast-enhanced head and neck CTA is feasible using a scan protocol with low amounts of contrast medium ( 40 mL ) on a 128-slice dual-energy CTA .
CONCLUSIONS	The 40-mL protocol provides satisfactory image quality before and after dual-energy bone-removal post-processing .

###26390725
OBJECTIVE	To evaluate the late cardiotoxicity ( CT ) of high-dose chemotherapy ( CT ) according to the modified NHL-BFM-90 ( mNHL-BFM-90 ) protocol in adult patients with diffuse large B-cell lymphoma ( DLBCL ) .
METHODS	The results of electrocardiography ( ECG ) and echocardiography ( echoCG ) were analyzed in 40 DLBCL patients treated according to the mNHL-BFM-90 program in the Hematology Research Center ( HRC ) , Russian Academy of Medical Sciences ( RAMS ) , in 2002 to 2009 .
METHODS	A study group consisted of 20 men and 20 women whose age was 31 to 76 years ; median age was 56.5 years at the time of their examination and the median follow-up time after therapy was 6 years .
METHODS	The individual cumulative dose of doxorubicin was 150-300 mg/M2 .
METHODS	A comparison group included 19 patients receiving CHOP/R-CHOP CT in HRC , RAMS , in 2002 to 2009 .
METHODS	Out of them , there were 8 men and 11 women whose age was 39 to 78 years median age was 70 years at the time of their examination .
METHODS	The individual cumulative dose of doxorubicin was 200-400 mg/M2 .
METHODS	ECG and echoCG were carried out before and 5 years or more after CT. .
RESULTS	Out of the 40 patients with DLBCL , the signs of subclinical cardiomyopathy ( CMP ) were detected in 24 ( 60 % ) patients ; no clinical manifestations of congestive heart failure ( CHF ) were found in any patient .
RESULTS	In the comparison group of 19 patients receiving CHOP/R-CHOP CT , 14 ( 74 % ) patients were found to have signs of subclinical CMP and no clinical signs of CHF .
RESULTS	The summary toxicity index significantly depended on age ( p = 0.03 ) and a history of heart disease ( p = 0.3 ) ; it was significantly higher after CHOP/R-CHOP CT ( p = 0.05 ) .
RESULTS	There was a statistically significant relationship of the risk of subclinical CMP to the history of heart diseases ( p = 0.05 ) .
CONCLUSIONS	Late cardiotoxicity of the mNHL-BFM-90 program does not exceed the toxicity of standard CHOP/R-CHOP therapy .
CONCLUSIONS	Post-CT Echo-CG and ECG findings showed that the patients with the most marked subclinical signs of CMP in both groups had cardiotoxicity risk factors , such as coronary heart disease , hypertensive disease , or diabetes in their history .
CONCLUSIONS	No clinically significant CHF was identified in any patient .

###25743937
BACKGROUND	Patients with metastatic castration-resistant prostate cancer have few treatment options .
BACKGROUND	We investigated the safety and efficacy of lenalidomide , an immunomodulatory agent with anti-angiogenic properties , in combination with docetaxel and prednisone in chemotherapy-naive patients with metastatic castration-resistant prostate cancer .
METHODS	In this randomised , double-blind , placebo-controlled , phase 3 study , we randomly assigned chemotherapy-naive patients with progressive metastatic castration-resistant prostate cancer in a 1:1 ratio to receive docetaxel ( 75 mg/m ( 2 ) ) on day 1 and prednisone ( 5 mg twice daily ) on days 1-21 and either lenalidomide ( 25 mg ) or placebo once daily on days 1-14 of each 21 day treatment cycle .
METHODS	Permuted block randomisation was done with an interactive voice response system and stratified by Eastern Cooperative Oncology Group performance status , geographic region , and type of disease progression .
METHODS	Clinicians , patients , and investigators were masked to treatment allocation .
METHODS	The primary endpoint was overall survival .
METHODS	Efficacy analysis was by intention to treat .
METHODS	Patients who received at least one dose of study drug were included in the safety analyses .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00988208 .
RESULTS	1059 patients were enrolled and randomly assigned between Nov 11 , 2009 , and Nov 23 , 2011 ( 533 to the lenalidomide group and 526 to the control group ) , and 1046 patients received study treatment ( 525 in the lenalidomide group and 521 in the placebo group ) .
RESULTS	At data cutoff ( Jan 13 , 2012 ) after a median follow-up of 8 months ( IQR 5-12 ) , 221 patients had died : 129 in the lenalidomide group and 92 in the placebo group .
RESULTS	Median overall survival was 177 months ( 95 % CI 148-188 ) in the lenalidomide group and not reached in the placebo group ( hazard ratio [ HR ] 153 , 95 % CI 117-200 , p = 00017 ) .
RESULTS	The trial was subsequently closed early due to futility .
RESULTS	The number of deaths that occurred during treatment or less than 28 days since the last dose were similar in both groups ( 18 [ 3 % ] of 525 patients in the lenalidomide group vs 13 [ 2 % ] of 521 patients ) .
RESULTS	109 ( 21 % ) patients in the lenalidomide group and 78 ( 15 % ) in the placebo group died more than 28 days from last dose , mainly due to disease progression .
RESULTS	At least one grade 3 or higher adverse event was reported in 381 ( 73 % ) of 525 patients receiving lenalidomide and 303 ( 58 % ) of 521 patients receiving placebo .
RESULTS	Grade 3-4 neutropenia ( 114 [ 22 % ] for lenalidomide vs 85 [ 16 % ] for placebo ) , febrile neutropenia ( 62 [ 12 % ] vs 23 [ 4 % ] ) , diarrhoea ( 37 [ 7 % ] vs 12 [ 2 % ] ) , pneumonia ( 24 [ 5 % ] vs five [ 1 % ] ) , dyspnoea ( 22 [ 4 % ] vs nine [ 2 % ] ) , asthenia ( 27 [ 5 % ] vs 17 [ 3 % ] ) , and pulmonary embolism ( 32 [ 6 % ] vs seven [ 1 % ] ) occurred more frequently in the lenalidomide group than in the placebo group .
CONCLUSIONS	Overall survival with the combination of lenalidomide , docetaxel , and prednisone was significantly worse than with docetaxel and prednisone for chemotherapy-naive men with metastatic , castration-resistant prostate cancer .
CONCLUSIONS	Further research with this treatment combination is not warranted .
BACKGROUND	Celgene Corporation .

###25399847
BACKGROUND	The Dual Antiplatelet Therapy Study is large streamlined clinical trial designed to evaluate antiplatelet treatment strategies in a broadly inclusive population of subjects treated with coronary stents .
BACKGROUND	Whether large streamlined trials can successfully include a representative group of study sites and patients has not been formally assessed .
RESULTS	Within the National Cardiovascular Data Registry CathPCI Registry , we compared characteristics and outcomes of hospitals participating versus not participating in the Dual Antiplatelet Therapy Study .
RESULTS	We also compared clinical and procedural characteristics of trial subjects undergoing percutaneous coronary intervention ( PCI ) with drug-eluting stents to contemporaneous patients within the National Cardiovascular Data Registry CathPCI Registry .
RESULTS	Standardized differences between groups were estimated .
RESULTS	Between September 2009 and July 2011 , 1.1 million PCIs were performed among 1276 hospitals , of which 309 ( 24.2 % ) participated in the Dual Antiplatelet Therapy Study .
RESULTS	Participating hospitals were larger ( 468 versus 311 beds ) , more frequently located in urban settings ( 61.2 % versus 42.6 % ) , and had higher annual PCI volumes ( 858 versus 378 ) compared with nonparticipating hospitals , although hospital case mix and procedural outcomes were similar .
RESULTS	Compared with CathPCI patients , trial patients undergoing PCI with drug-eluting stents were similar with respect to race , sex , and rates of diabetes mellitus , hypertension , and smoking , although they had lower rates of prior cardiovascular disease .
CONCLUSIONS	Within the Dual Antiplatelet Therapy Study , clinical trial sites had similar patient case mix and clinical outcomes as nonparticipating sites .
CONCLUSIONS	Although trial participants were representative of PCI patients with respect to race , sex and most comorbidities , they had a lower prevalence of chronic cardiovascular disease compared with registry patients .
CONCLUSIONS	Although a streamlined cardiovascular clinical trial may successfully involve a large number of hospitals and rapidly enroll a diverse population of patients , differences between eligible patients and those actually enrolled remained .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00977938 .

###25388791
OBJECTIVE	To evaluate the safety and feasibility of the da Vinci Surgical System in transoral robotic-assisted surgery for benign indications .
METHODS	A multicenter , single-arm , retrospective case series .
METHODS	Perioperative outcomes were recorded for patients presenting with obstructive sleep apnea , airway obstruction , lingual tonsillar/tonsillar/tongue base hypertrophy , or dysphagia who underwent one or more transoral procedures , including lingual tonsillectomy and tongue base resection ( partial glossectomy ) at one of three US institutions .
RESULTS	Between January 2010 and October 2013 , 285 patients ( age 51.5 years , body mass index 30.5 kg/m ( 2 ) ) underwent 293 procedures .
RESULTS	No conversions or blood transfusions were needed .
RESULTS	The average operative time was 86.7 minutes , and the average volume of tissue resected ( lingual tonsil and tongue base ) was 8.3 mL .
RESULTS	Hospital stays averaged 1.8 days , and the postoperative complication rate was 20.7 % .
RESULTS	There were no complications specifically related to the use the da Vinci Surgical System , and none of the complications were life threatening .
CONCLUSIONS	These results demonstrate that it is safe and feasible to use the da Vinci Surgical System to perform lingual tonsillectomy and base of tongue resection ( partial glossectomy ) procedures for benign indications .

###24347773
OBJECTIVE	The aim of this study was to investigate the efficacy of dezocine ( DEZ ) versus placebo control ( CON ) and 2 % lidocaine ( LID ) in prevention of injection pain due to DEZ .
METHODS	A prospective randomized double-blind , placebo-CON study was conducted in 75 adults , American Society of Anesthesiologists physical status I or II , scheduled to undergo an elective surgery .
METHODS	A total of 25 patients were randomly assigned to one of the three groups , thus CON , group LID and group DEZ .
METHODS	The groups received either 2 ml of normal saline or 2 ml 2 % LID or 2 mg/2 ml DEZ , respectively , as pre-treatment .
METHODS	Propofol was injected 1 min later .
METHODS	A blinded researcher assessed the patient 's pain level using a four point verbal rating scale .
RESULTS	Less patients experienced pain due to propofol injection in the LID ( 40 % ) and DEZ ( 28 % ) groups compared with the CON ( 84 % ) group ( P < 0.05 ) .
RESULTS	Six patients ( 24 % ) in the CON group reported severe pain during propofol injection but none in the other two groups .
CONCLUSIONS	Pre-treatment with DEZ decreases propofol injection pain as effectively as LID .

###25637340
BACKGROUND	For most older women with early breast cancer , standard treatment after breast-conserving surgery is adjuvant whole-breast radiotherapy and adjuvant endocrine treatment .
BACKGROUND	We aimed to assess the effect omission of whole-breast radiotherapy would have on local control in older women at low risk of local recurrence at 5 years .
METHODS	Between April 16 , 2003 , and Dec 22 , 2009 , 1326 women aged 65 years or older with early breast cancer judged low-risk ( ie , hormone receptor-positive , axillary node-negative , T1-T2 up to 3 cm at the longest dimension , and clear margins ; grade 3 tumour histology or lymphovascular invasion , but not both , were permitted ) , who had had breast-conserving surgery and were receiving adjuvant endocrine treatment , were recruited into a phase 3 randomised controlled trial at 76 centres in four countries .
METHODS	Eligible patients were randomly assigned to either whole-breast radiotherapy ( 40-50 Gy in 15-25 fractions ) or no radiotherapy by computer-generated permuted block randomisation , stratified by centre , with a block size of four .
METHODS	The primary endpoint was ipsilateral breast tumour recurrence .
METHODS	Follow-up continues and will end at the 10-year anniversary of the last randomised patient .
METHODS	Analyses were done by intention to treat .
METHODS	The trial is registered on ISRCTN.com , number ISRCTN95889329 .
RESULTS	658 women who had undergone breast-conserving surgery and who were receiving adjuvant endocrine treatment were randomly assigned to receive whole-breast irradiation and 668 were allocated to no further treatment .
RESULTS	After median follow-up of 5 years ( IQR 384-605 ) , ipsilateral breast tumour recurrence was 13 % ( 95 % CI 02-23 ; n = 5 ) in women assigned to whole-breast radiotherapy and 41 % ( 24-57 ; n = 26 ) in those assigned no radiotherapy ( p = 00002 ) .
RESULTS	Compared with women allocated to whole-breast radiotherapy , the univariate hazard ratio for ipsilateral breast tumour recurrence in women assigned to no radiotherapy was 519 ( 95 % CI 199-1352 ; p = 00007 ) .
RESULTS	No differences in regional recurrence , distant metastases , contralateral breast cancers , or new breast cancers were noted between groups .
RESULTS	5-year overall survival was 939 % ( 95 % CI 918-960 ) in both groups ( p = 034 ) .
RESULTS	89 women died ; eight of 49 patients allocated to no radiotherapy and four of 40 assigned to radiotherapy died from breast cancer .
CONCLUSIONS	Postoperative whole-breast radiotherapy after breast-conserving surgery and adjuvant endocrine treatment resulted in a significant but modest reduction in local recurrence for women aged 65 years or older with early breast cancer 5 years after randomisation .
CONCLUSIONS	However , the 5-year rate of ipsilateral breast tumour recurrence is probably low enough for omission of radiotherapy to be considered for some patients .
BACKGROUND	Chief Scientist Office ( Scottish Government ) , Breast Cancer Institute ( Western General Hospital , Edinburgh ) .

###25854012
OBJECTIVE	To explore the impact and effect mechanism of electroacupuncture ( EA ) on oocyte quali ty in the patients with infertility of kidney deficiency pattern .
METHODS	Sixty-six cases differentiated as kidney de ficiency and with in vitro fertilization-embryo transplantation ( IVF-ET ) , aged fromnt 35 to 42 years were rando - mized into an observation group and a control group , 33 cases in each one .
METHODS	The IVF-ET therapy of the long proto - col with gonadotrophin releasing hormone agonist was adopted in the two groups .
METHODS	In the observation group .
METHODS	on the 5th day of menstruation in IVF cycle , EA was applied to Sanyinjiao ( SP 6 ) .
METHODS	Zigong ( EX CA 1 ) , Zhongji ( CV 3 ) and Guanyuan ( CV 4 ) .
METHODS	In the control group , the sham-acupuncture was applied to the same acupoints .
METHODS	The treatment was given once every two days till the date of egg collection and the needles were retained for 30 min each time .
METHODS	The change in the score of kidney deficiency syndrome , the high-quality oocyte rate , the high-quality embryo rate and clinical pregnant rate were observed in the two groups .
METHODS	The levels of insulin-like growth factor-i ( IGF-1 ) and IGF-2 in follicular fluid and the serum - endorphin - EP ) on the date of egg collection and the correlation with oocyte quality were compared bIetween the two groups .
RESULTS	1 ) In the observation group , the kidney deficiency syndrome score after treatment was reduced apparently as compared with that before treatment ( P < 0.05 ) , the score after treatment in the observation group was reduced much more apparently as compared with the control group ( P < 0.05 ) .
RESULTS	2 ) The high-quality egg rate and the high-quality embryo rate in the observation group were both higher than those in the control group [ 81.3 % ( 161/198 ) vs 57.6 % ( 98/170 ) , 59.8 % ( 58/97 ) vs 37.7 % ( 26/69 ) , both P < 0.05 ] .
RESULTS	3 ) Compared with the control group .
RESULTS	the levels of IGF-1 and IGF-2 in follicular fluid and serum - EP on the day of egg collection were all increased obviously in the observation group ( all P < 0.05 ) .
RESULTS	4 ) The levels of IGF-1 and IGF-2 in follicular fluid and serum - EP presented the linear positive correlation with the high-quality egg rate .
CONCLUSIONS	EA effectively improves the expressions of IGF in follicular fluid and serum - EP , increases the high-quality egg rate and high-quality embryo rate and relieves the symptoms of kidney deficiency .

###24676313
OBJECTIVE	The aim of this work was to evaluate the effect of long term supplementation with two moderate dose of Zn on plasma and cellular red-ox status markers in elderly volunteers .
METHODS	In a double blind study 108 healthy volunteers , aged 70-85 years , were enrolled .
METHODS	They were randomly divided in 3 groups of treatment , receiving placebo , 15 mg/day and 30 mg/day of Zn for 6 months .
METHODS	Red-ox status markers were assessed at baseline and after 6 months evaluating carotenoids , vitamin A and E in plasma ; glutathione ( GSH ) , thiol groups ( RSH ) , malondialdehyde ( MDA ) , percentage of haemolysis and methemoglobin in erythrocytes .
RESULTS	Zn supplementation had no significant effects on red-ox status markers except for vitamin A levels ( from 1.940.44 to 2.180.48 M in volunteers receiving 15 mg of Zn and from 1.950.46 to 2.260.56 M in volunteers receiving 30 mg of Zn ) , which increased proportionally to zinc dose .
CONCLUSIONS	It appears that , differently from unhealthy populations , long-term supplementation with two moderate doses of Zn in a healthy elderly population , with an adequate Zn nutritive status and macro and micronutrients intakes in the range of normality , is an inefficient way to increase antioxidant defences .

###24823692
OBJECTIVE	This study extends previous work on longitudinal patterns of spousal associations between functional impairments and psychological well-being in older couples in 3 important ways : By examining Mexican Americans , by considering a broader range of functional limitations , and by assessing the role of health status , social integration , and socioeconomic resources in these associations .
METHODS	Drawing on data from 6 waves of the Hispanic Established Population for the Epidemiologic Study of the Elderly ( 1993-2007 ) , we employed growth curve models to investigate the implications of the spouse 's functional limitations for the respondent 's age trajectories of depressive symptoms in older Mexican American couples .
METHODS	Models were run separately for husbands and wives .
RESULTS	The spouse 's functional limitations were associated with higher levels of depressive symptoms in the respondent .
RESULTS	Personal resources can both ameliorate and intensify the adverse implications of the spouse 's functional limitations for the respondent 's depressive symptomatology .
RESULTS	The interplay among these factors can vary by gender and the type of the spouse 's functional impairment .
CONCLUSIONS	Future studies would benefit by examining caregiving patterns in older couples , by distinguishing between different dimensions of social support available to them , and by considering changes in couples ' marital quality and social ties over time .

###24383930
BACKGROUND	Interleukin-1 ( IL-1 ) is a key mediator of ischaemic brain injury induced by stroke and subarachnoid haemorrhage ( SAH ) .
BACKGROUND	IL-1 receptor antagonist ( IL-1Ra ) limits brain injury in experimental stroke and reduces plasma inflammatory mediators associated with poor outcome in ischaemic stroke patients .
BACKGROUND	Intravenous ( IV ) IL-1Ra crosses the blood-brain barrier ( BBB ) in patients with SAH , to achieve cerebrospinal fluid ( CSF ) concentrations that are neuroprotective in rats .
METHODS	A small phase II , double-blind , randomised controlled study was carried out across two UK neurosurgical centres with the aim of recruiting 32 patients .
METHODS	Adult patients with aneurysmal SAH , requiring external ventricular drainage ( EVD ) within 72 hours of ictus , were eligible .
METHODS	Patients were randomised to receive IL-1Ra ( 500 mg bolus , then a 10 mg/kg/hr infusion for 24 hours ) or placebo .
METHODS	Serial samples of CSF and plasma were taken and analysed for inflammatory mediators , with change in CSF IL-6 between 6 and 24 hours as the primary outcome measure .
RESULTS	Six patients received IL-1Ra and seven received placebo .
RESULTS	Concentrations of IL-6 in CSF and plasma were reduced by one standard deviation in the IL-1Ra group compared to the placebo group , between 6 and 24 hours , as predicted by the power calculation .
RESULTS	This did not reach statistical significance ( P = 0.08 and P = 0.06 , respectively ) , since recruitment did not reach the target figure of 32 .
RESULTS	No adverse or serious adverse events reported were attributable to IL-1Ra .
CONCLUSIONS	IL-1Ra appears safe in SAH patients .
CONCLUSIONS	The concentration of IL-6 was lowered to the degree expected , in both CSF and plasma for patients treated with IL-1Ra .

###25060545
BACKGROUND	Perioperative supplemental oxygen has been proposed to decrease the incidence of surgical site infection ( SSI ) in colorectal surgery with controversial results .
BACKGROUND	We have assessed the influence of hyperoxygenation on SSI by using the most homogeneous study population .
METHODS	We studied , in a prospective randomized study , 81 patients , who underwent elective open infraperitoneal anastomosis for rectal cancer .
METHODS	Patients were assigned randomly to an oxygen/air mixture with a fraction of inspired oxygen ( FiO2 ) of 30 % ( n = 41 ) or 80 % ( n = 40 ) .
METHODS	Administration was commenced after induction of anesthesia and maintained for 6hours after surgery .
RESULTS	The overall wound infection rate was 21 % : 11 patients ( 26.8 % ) had wound infections in the 30 % FiO2 group and 6 ( 15 % ) in the 80 % FiO2 group ( P < .05 ) .
RESULTS	The risk of SSI was 41 % lower in the 80 % FiO2 group .
CONCLUSIONS	Supplemental 80 % FiO2 reduced postoperative SSI with few risks to the patient and little associated cost .

###25227114
BACKGROUND	Early goal-directed therapy refers to the use of predefined hemodynamic goals to optimize tissue oxygen delivery in critically ill patients .
BACKGROUND	Its application in high-risk abdominal surgery is , however , hindered by safety concerns and practical limitations of perioperative hemodynamic monitoring .
BACKGROUND	Arterial waveform analysis provides an easy , minimally invasive alternative to conventional monitoring techniques , and could be valuable in early goal-directed strategies .
BACKGROUND	We therefore investigate the effects of early goal-directed therapy using arterial waveform analysis on complications , quality of life and healthcare costs after high-risk abdominal surgery .
METHODS	In this multicenter , randomized , controlled superiority trial , 542 patients scheduled for elective , high-risk abdominal surgery will be included .
METHODS	Patients are allocated to standard care ( control group ) or early goal-directed therapy ( intervention group ) using a randomization procedure stratified by center and type of surgery .
METHODS	In the control group , standard perioperative hemodynamic monitoring is applied .
METHODS	In the intervention group , early goal-directed therapy is added to standard care , based on continuous monitoring of cardiac output with arterial waveform analysis .
METHODS	A treatment algorithm is used as guidance for fluid and inotropic therapy to maintain cardiac output above a preset , age-dependent target value .
METHODS	The primary outcome measure is a combined endpoint of major complications in the first 30 days after the operation , including mortality .
METHODS	Secondary endpoints are length of stay in the hospital , length of stay in the intensive care or post-anesthesia care unit , the number of minor complications , quality of life , cost-effectiveness and one-year mortality and morbidity .
CONCLUSIONS	Before the start of the study , hemodynamic optimization by early goal-directed therapy with arterial waveform analysis had only been investigated in small , single-center studies , including minor complications as primary endpoint .
CONCLUSIONS	Moreover , these studies did not include quality of life , healthcare costs , and long-term outcome in their analysis .
CONCLUSIONS	As a result , the definitive role of arterial waveform analysis in the perioperative hemodynamic assessment and care for high-risk surgical patients is unknown , which gave rise to the present trial .
CONCLUSIONS	Patient inclusion started in May 2012 and is expected to end in 2016 .
BACKGROUND	This trial was registered in the Dutch Trial Register ( registration number NTR3380 ) on 3 April 2012 .

###25832425
OBJECTIVE	To investigate the QT/QTc effects of orally administered moxifloxacin in healthy Chinese volunteers .
METHODS	This was a single-blinded , randomized , single-dose , placebo-controlled , two-period cross-over study .
METHODS	A total of 24 healthy Chinese volunteers were enrolled , randomly assigned to two groups : one group received moxifloxacin ( 400 mg , po ) followed by placebo with a 7-d interval , another group received placebo followed by moxifloxacin with a 7-d interval .
METHODS	On the days of dosing , 12-lead 24 h Holter ECGs were recorded and evaluated by an ECG laboratory blind to the treatments .
METHODS	Blood samples were collected to determine plasma concentrations of moxifloxacin .
RESULTS	The orally administered moxifloxacin significantly prolonged the mean QTc at all time points except 0.5 h post-dose .
RESULTS	The largest time-matched difference in the QTcI was 8.35 ms ( 90 % CI : 5.43 , 11.27 ) at 4 h post-dose .
RESULTS	The peak effect on QTcF was 9.35 ms ( 90 % CI : 6.36 , 12.34 ) at 3 h post-dose .
RESULTS	A pharmacokinetic-QTc model suggested a 2.084 ms increase in the QTc interval for every 1000 ng/mL increase in plasma concentration of moxifloxacin .
RESULTS	In addition , the orally administered moxifloxacin was well tolerated by the subjects .
CONCLUSIONS	Orally administered moxifloxacin significantly prolongs QTc , which supports its use as a positive control in ICH-E14 TQT studies in Chinese volunteers .

###24666170
BACKGROUND	Cold atmospheric plasma ( CAP , i.e. ionized air ) is an innovating promising tool in reducing bacteria .
OBJECTIVE	We conducted the first clinical trial with the novel PlasmaDerm VU-2010 device to assess safety and , as secondary endpoints , efficacy and applicability of 45 s/cm ( 2 ) cold atmospheric plasma as add-on therapy against chronic venous leg ulcers .
METHODS	From April 2011 to April 2012 , 14 patients were randomized to receive standardized modern wound care ( n = 7 ) or plasma in addition to standard care ( n = 7 ) 3 per week for 8 weeks .
METHODS	The ulcer size was determined weekly ( Visitrak , photodocumentation ) .
METHODS	Bacterial load ( bacterial swabs , contact agar plates ) and pain during and between treatments ( visual analogue scales ) were assessed .
METHODS	Patients and doctors rated the applicability of plasma ( questionnaires ) .
RESULTS	The plasma treatment was safe with 2 SAEs and 77 AEs approximately equally distributed among both groups ( P = 0.77 and P = 1.0 , Fisher 's exact test ) .
RESULTS	Two AEs probably related to plasma .
RESULTS	Plasma treatment resulted in a significant reduction in lesional bacterial load ( P = 0.04 , Wilcoxon signed-rank test ) .
RESULTS	A more than 50 % ulcer size reduction was noted in 5/7 and 4/7 patients in the standard and plasma groups , respectively , and a greater size reduction occurred in the plasma group ( plasma -5.3 cm ( 2 ) , standard : -3.4 cm ( 2 ) ) ( non-significant , P = 0.42 , log-rank test ) .
RESULTS	The only ulcer that closed after 7 weeks received plasma .
RESULTS	Patients in the plasma group quoted less pain compared to the control group .
RESULTS	The plasma applicability was not rated inferior to standard wound care ( P = 0.94 , Wilcoxon-Mann-Whitney test ) .
RESULTS	Physicians would recommend ( P = 0.06 , Wilcoxon-Mann-Whitney test ) or repeat ( P = 0.08 , Wilcoxon-Mann-Whitney test ) plasma treatment by trend .
CONCLUSIONS	Cold atmospheric plasma displays favourable antibacterial effects .
CONCLUSIONS	We demonstrated that plasma treatment with the PlasmaDerm VU-2010 device is safe and effective in patients with chronic venous leg ulcers .
CONCLUSIONS	Thus , larger controlled trials and the development of devices with larger application surfaces are warranted .

###25548845
BACKGROUND	RT002 is a new injectable BoNTA product .
BACKGROUND	This formulation limits the spread of BoNTA , potentially permitting safe administration of larger doses and possibly extending its duration of action .
OBJECTIVE	This phase 1/2 clinical study was designed to establish the safety of RT002 for the treatment of moderate-to-severe glabellar lines .
METHODS	Subjects were randomized into four groups ( N = 12/group ) .
METHODS	Cohorts 1-3 received escalating doses of RT002 ranging from half the equivalent dose of approved toxins up to twice the current dose levels .
METHODS	The safety of each dose was confirmed prior to administering the next dose .
METHODS	Subjects in Cohort 4 were treated with the highest dose and observed for 36 weeks or until GLSS returned to baseline .
RESULTS	All doses of RT002 were well-tolerated .
RESULTS	Common AEs were headache and mild injection site reactions .
RESULTS	At Week 4 , all doses of RT002 were highly effective at maximum frown .
RESULTS	Cohort 4 achieved 7 month median duration .
RESULTS	At 6 months , 80 % of subjects maintained a 1-point improvement in Investigator GLSS and 60 % maintained WSS of None or Mild .
RESULTS	Study limitations include an open-label design and modest number of subjects .
CONCLUSIONS	RT002 is a safe and effective BoNTA product with an extended duration of action .

###24937975
OBJECTIVE	To compare the clinical pregnancy rates in women who underwent fresh embryo transfer ( ET ) with and without one acupuncture session before and after the transfer using a modified Paulus protocol .
METHODS	The prospective , physician-blinded study randomized 113 women to either no intervention ( n = 56 ) or acupuncture performed off-site ( n = 57 ) .
METHODS	Secondary outcomes were positive pregnancy test and live birth rates .
METHODS	Intent-to-treat analysis and per protocol analysis were performed .
RESULTS	No difference in age and in vitro fertilization-embryo transfer ( IVF-ET ) parameters were detected .
RESULTS	Compared to the control group , the treatment group had a lower pregnancy rate ( 43.6 % vs. 64.8 % , p = 0.045 ) .
RESULTS	More women in the control group had live births than did those in the acupuncture group ( 56.0 % vs. 36.0 % , respectively , p = 0.033 ) .
RESULTS	Generalized mixed models revealed that patients who received acupuncture had lower odds of clinical pregnancy than those who did not undergo acupuncture treatment ( OR = 0.42 , 95 % CI 0.19-0 .93 ) .
CONCLUSIONS	Our study found that acupuncture performed off-site on the day of ET was detrimental to the success of the transfer .
CONCLUSIONS	More research is needed with a greater number of subjects to elucidate the role of acupuncture before and after ET , ideal treatment frequency , and to further explore the role of individualized acupuncture treatment on IVF-ET pregnancy rates .

###24257721
BACKGROUND	The energy intake necessary to maintain weight and body composition is called the energy requirement for weight maintenance and can be determined by using the doubly labeled water ( DLW ) method .
OBJECTIVE	The objective was to determine the energy requirements of nonobese men and women in the Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy 2 study .
METHODS	Energy requirements were determined for 217 healthy , weight-stable men and women [ aged > 21 to < 50 y ; 70 % female , 77 % white ; body mass index ( BMI ; in kg/m ( 2 ) ) 22 to < 28 ; 52 % overweight ] over 28 d with 2 consecutive 14-d DLW assessments in addition to serial measures of body weight and fat-free mass and fat mass by dual-energy X-ray absorptiometry .
METHODS	Energy intake and physical activity were also estimated by self-report over 6 consecutive d in each DLW period .
RESULTS	Total daily energy expenditure ( TDEE ) was consistent between the 2 DLW studies ( TDEE1 : 2422 404 kcal/d ; TDEE2 : 2465 408 kcal/d ; intraclass correlation coefficient = 0.90 ) with a mean TDEE of 2443 397 kcal/d that was , on average , 20 % ( 580 kcal/d ) higher in men than in women ( P < 0.0001 ) .
RESULTS	The regression equation relating mean TDEE to demographics and weight was as follows : TDEE ( kcal/d ) = 1279 + 18.3 ( weight , kg ) + 2.3 ( age , y ) - 338 ( sex : 1 = female , 0 = male ) ; R ( 2 ) = 0.57 .
RESULTS	When body composition was included , TDEE ( kcal/d ) = 454 + 38.7 ( fat-free mass , kg ) - 5.4 ( fat mass , kg ) + 4.7 ( age in y ) + 103 ( sex : 1 = female , 0 = male ) ; R ( 2 ) = 0.65 .
RESULTS	Individuals significantly underreported energy intake ( 350 kcal/d ; 15 % ) , and underreporting by overweight individuals ( ~ 400 kcal/d ; 16 % ) was greater ( P < 0.001 ) than that of normal-weight individuals ( ~ 270 kcal/d ; 12 % ) .
RESULTS	Estimates of TDEE from a 7-d physical activity recall and measured resting metabolic rate also suggested that individuals significantly underreported physical activity ( ~ 400 kcal/d ; 17 % ; P < 0.0001 ) .
CONCLUSIONS	These new equations derived over 1 mo during weight stability can be used to estimate the free-living caloric requirements of nonobese adults .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT00427193 .

###24228504
OBJECTIVE	To investigate the effect of vacuum drainage on blood circulation of expanded skin flap , so as to confirm suitable negative pressure for ear reconstruction .
METHODS	21 patients ( Auricular Reconstructive Center of Plastic Surgery Hospital , PUMC ) were randomly divided into A , B , C 3 groups to receive vacuum drainage of : -20 , -40 and -60 kPa , respectively .
METHODS	The length and width of reconstructed ears , which represented the swelling degree , were measured instantly and 5 , 10 days postoperatively .
METHODS	The changes were calculated and reflected venous drainage of flaps .
METHODS	The temperature of proximal ( concha ) and distal ( helix ) part of the expanded flaps , which represented the arterial blood supply of flaps , was detected by infrared thermography after operation .
RESULTS	Five days after operation [ ( 1.48 + / - 0.47 ) mm , ( 0.36 + / - 0.06 ) mm ] and immediately [ ( 1.67 + / - 0.69 ) mm , ( 0.40 + / - 0.16 ) mm ) ] , the changes of the length and width of reconstructed ear in group B was significantly low , while there was no statistically difference between group A and C ( P > 0.05 ) .
RESULTS	The data between 10 days and 5 days after operation showed the same result .
RESULTS	Along with the increase of the negative pressure , the swelling degree of reconstructed ears decreased firstly and then increased reversely ( P < 0.01 ) .
RESULTS	The flap temperature of reconstructed ears increased ( P < 0.01 ) , especially in proximal ( concha ) part ( P < 0.01 ) , when the negative pressure increased ( 0 to -60 kPa ) .
CONCLUSIONS	Vacuum drainage has effect on both the venous drainage and blood supply .
CONCLUSIONS	Negative pressure of -40 kPa can improve both the blood supply and venous drainage .
CONCLUSIONS	It should be as reference for clinical application .

###25314069
BACKGROUND	Recent data suggest the possible benefits of - tocopherol and - carotene supplementation on liver cancer and chronic liver disease ( CLD ) , but the long-term trial data are limited .
METHODS	We evaluated the efficacy of supplemental 50mgday ( -1 ) - tocopherol and 20mgday ( -1 ) - carotene on incident liver cancer and CLD mortality in a randomised trial of 29,105 Finnish male smokers , who received supplementation for 5-8 years and were followed for 16 additional years for outcomes .
RESULTS	Supplemental - tocopherol , - carotene , or both , relative to placebo , did not reduce the risk of liver cancer or CLD , either overall , during the intervention or during the post-intervention period .
CONCLUSIONS	Long-term supplemental - tocopherol or - carotene had no effect on liver cancer or CLD mortality over 24 years of follow-up .

###25099748
BACKGROUND	The analgesic efficacy of sciatic nerve block ( SNB ) after total knee arthroplasty ( TKA ) is unclear .
BACKGROUND	Proximal and distal SNB are each reported to provide posterior knee analgesia , whereas others suggest that posterior knee pain is not important after TKA .
BACKGROUND	This prospective , randomized , double-blind , parallel-arm , placebo-controlled trial examined whether proximal or distal SNB provides superior analgesia in the posterior knee compared with no SNB after TKA .
METHODS	Sixty patients undergoing TKA were randomized to single-shot SNB using either the infragluteal ( Proximal group ) or popliteal ( Distal group ) technique , or no SNB ( Placebo group ) .
METHODS	All patients received spinal anesthesia and continuous-femoral nerve blockade .
METHODS	A blinded observer assessed posterior and anterior knee pain at 2 , 4 , 6 , 8 , 12 , and 24 h postoperatively .
METHODS	The primary outcome was moderate-to-severe posterior knee pain at 4 h postoperatively ; secondary outcomes included SNB procedural time , needle passes , and discomfort .
RESULTS	Fifty-three patients were analyzed .
RESULTS	The proportion of patients ( Proximal : Distal : Placebo ) who experienced moderate-to-severe posterior knee pain was 18 % :22 % :89 % ( P < 0.00001 ) at 2 h , 24 % :28 % :72 % ( P < 0.01 ) at 4 h , and 12 % :17 % :78 % ( P = 0.00003 ) at 6 h postoperatively .
RESULTS	For the anterior knee , the proportion of patients reporting moderate-to-severe pain was 6 % :11 % :44 % ( P = 0.02 ) at 2 h , 6 % :6 % :39 % ( P = 0.012 ) at 4 h , and 12 % :6 % :44 % ( P = 0.017 ) at 6 h postoperatively .
RESULTS	Moderate-to-severe pain did not differ between groups beyond 6 h. Both proximal and distal SNB reduced rest pain in the posterior and anterior knee up to 8 h postoperatively compared with no SNB .
RESULTS	The popliteal technique required shorter procedural time , fewer needle passes , and produced less discomfort .
CONCLUSIONS	Proximal and distal SNB each reduce posterior and anterior knee pain after TKA compared with no SNB .

###24936727
OBJECTIVE	The aim of this study was to determine the role of omega-3 supplementation on NEFA concentration , insulin sensitivity and resistance , and glucose and lipid metabolism in type 2 diabetic patients .
METHODS	Forty-four type 2 diabetic patients were randomly recruited into two groups .
METHODS	Group A received 4 g/day omega-3 soft gels , and group B received a placebo for 10 wks .
METHODS	Blood samples were collected after 12-h fast .
METHODS	Physical activity records , three-day food records , and anthropometric measurements were obtained from all participants at the beginning and end of the study .
RESULTS	Omega-3 supplementation caused a significant reduction in NEFA in the intervention group compared with the placebo group ( P = 0.009 ) .
RESULTS	Additionally , the administration of omega-3 resulted in significantly greater changes ( Diff ) for the intervention group in various parameters , such as insulin and Quicki indices compared with the placebo group ( P < 0.05 ) .
CONCLUSIONS	Omega-3 fatty acid supplementation in type 2 diabetic patients improved insulin sensitivity , probably due to the decrease in NEFA concentrations .

###24368514
OBJECTIVE	The interleukin-6 receptor ( IL-6R ) blocker tocilizumab ( TCZ ) reduces inflammatory disease activity in rheumatoid arthritis ( RA ) but elevates lipid concentrations in some patients .
OBJECTIVE	We aimed to characterise the impact of IL-6R inhibition on established and novel risk factors in active RA .
METHODS	Randomised , multicentre , two-part , phase III trial ( 24-week double-blind , 80-week open-label ) , MEASURE , evaluated lipid and lipoprotein levels , high-density lipoprotein ( HDL ) particle composition , markers of coagulation , thrombosis and vascular function by pulse wave velocity ( PWV ) in 132 patients with RA who received TCZ or placebo .
RESULTS	Median total-cholesterol , low-density lipoprotein-cholesterol ( LDL-C ) and triglyceride levels increased in TCZ versus placebo recipients by week 12 ( 12.6 % vs 1.7 % , 28.1 % vs 2.2 % , 10.6 % vs -1.9 % , respectively ; all p < 0.01 ) .
RESULTS	There were no significant differences in mean small LDL , mean oxidised LDL or total HDL-C concentrations .
RESULTS	However , HDL-associated serum amyloid A content decreased in TCZ recipients .
RESULTS	TCZ also induced reductions ( > 30 % ) in secretory phospholipase A2-IIA , lipoprotein ( a ) , fibrinogen and D-dimers and elevation of paraoxonase ( all p < 0.0001 vs placebo ) .
RESULTS	The ApoB/ApoA1 ratio remained stable over time in both groups .
RESULTS	PWV decreases were greater with placebo than TCZ at 12weeks ( adjusted mean difference 0.79 m/s ( 95 % CI 0.22 to 1.35 ; p = 0.0067 ) ) .
CONCLUSIONS	These data provide the first detailed evidence for the modulation of lipoprotein particles and other surrogates of vascular risk with IL-6R inhibition .
CONCLUSIONS	When compared with placebo , TCZ induced elevations in LDL-C but altered HDL particles towards an anti-inflammatory composition and favourably modified most , but not all , measured vascular risk surrogates .
CONCLUSIONS	The net effect of such changes for cardiovascular risk requires determination .

###25312315
BACKGROUND	in the treatment of early osteoartrosis , analgesics and non-steroidal anti-inflammatory drugs are frequently used to relieve pain .
BACKGROUND	Currently , platelet rich plasma is used as an alternative in the treatment of osteoartrosis .
BACKGROUND	The aim of this study was to evaluate the effect of platelet rich plasma compared to paracetamol as a treatment for patients with knee osteoartrosis grade I.
METHODS	we evaluated 42 patients who were randomized into two groups .
METHODS	Group one was treated with 5 mL of platelet rich plasma in two applications , while group two was treated with 1 gr of oral paracetamol every 8 hours for 30 days .
METHODS	Both patient groups received supervised physical rehabilitation during the 6 month observation period .
METHODS	Peripheral blood samples were taken to measure plasma IL-1 , TNF-a and TGF-1 levels at day 0 and at 6 months post-treatment .
METHODS	Clinical evaluation was conducted using the KOOS at the start of the study and for every subsequent month during the study period .
RESULTS	the Knee injury and Osteoarthritis Outcome Score ( KOOS ) for group one at the start of the treatment was measured at 30.1 points , whereas at the end , it was measured at 48.2 points , showing a clinical improvement of 60 % .
RESULTS	There were no statistically significant differences in IL-1 and TNF-a levels between groups treated either with platelet rich plasma or paracetamol .
CONCLUSIONS	Our patients treated with platelet rich plasma showed a statistically significant increase in the serum levels of TGF-1 , which was associated with an improvement in the clinical evaluation used ( KOOS ) .

###24376568
BACKGROUND	High Frequency electrical Stimulation ( HFS ) of the skin induces enhanced brain responsiveness expressed as enhanced Event-Related Potential ( ERP ) N1 amplitude to stimuli applied to the surrounding unconditioned skin in healthy volunteers .
BACKGROUND	The aim of the present study was to investigate whether this enhanced ERP N1 amplitude could be a potential marker for altered cortical sensory processing in patients with persistent pain after surgery .
METHODS	Nineteen male patients ; 9 with and 10 without persistent pain after inguinal hernia repair received HFS .
METHODS	Before , directly after and thirty minutes after HFS evoked potentials and the subjective pain intensity were measured in response to electric pain stimuli applied to the surrounding unconditioned skin .
RESULTS	The results show that , thirty minutes after HFS , the ERP N1 amplitude observed at the conditioned arm was statistically significantly larger than the amplitude at the control arm across all patients .
RESULTS	No statistically significant differences were observed regarding ERP N1 amplitude between patients with and without persistent pain .
RESULTS	However , thirty minutes after HFS we did observe statistically significant differences of P2 amplitude at the conditioned arm between the two groups .
RESULTS	The P2 amplitude decreased in comparison to baseline in the group of patients with pain .
CONCLUSIONS	The ERP N1 effect , induced after HFS , was not different between patients with vs. without persistent pain .
CONCLUSIONS	The decreasing P2 amplitude was not observed in the patients without pain and also not in the previous healthy volunteer study and thus might be a marker for altered cortical sensory processing in patients with persistent pain after surgery .

###24480637
BACKGROUND	Pilsicainide hydrochloride is a class IC antiarrhythmic agent used for the treatment of supraventricular and ventricular arrhythmias and atrial fibrillation .
OBJECTIVE	The objective of the present study was to determine the pharmacokinetics ( PK ) of a pilsicainide hydrochloride injection in healthy Chinese adults .
OBJECTIVE	The study was conducted to meet China State Food and Drug Administration requirements for the marketing of the new generic formulation of pilsicainide hydrochloride .
METHODS	This Phase I , randomized , parallel-group , open-label , single-dose PK study was conducted in healthy Chinese volunteers .
METHODS	Subjects were randomized to receive a single dose of 0.25 - , 0.50 - , and 0.75-mg / kg pilsicainide hydrochloride with a 10-minute intravenous infusion .
METHODS	Serial blood and urine samples were collected up to 24 hours after dosing ; drug concentrations in plasma and urine were then determined by using LC-MS/MS .
METHODS	The PK parameters of pilsicainide were calculated from the plasma concentration-time data according to noncompartmental methods .
METHODS	Safety profile was evaluated by monitoring adverse events , clinical laboratory parameters , and the results of 12-lead ECGs .
RESULTS	Thirty healthy volunteers ( mean [ SD ] age , 28.0 [ 4.95 ] years ; weight , 59.3 [ 6.51 ] kg ; height , 165.0 [ 7.25 ] cm ; body mass index , 21.7 [ 1.94 ] kg/m ( 2 ) ) were randomly divided into 3 groups , each consisting of 5 men and 5 women .
RESULTS	After single-dose intravenous administration of 0.25 , 0.50 , and 0.75 mg/kg of pilsicainide hydrochloride , mean Cmax was 0.34 ( 0.11 ) , 0.54 ( 0.15 ) , and 1.05 ( 0.19 ) g/mL , respectively ; AUC0-24 was 0.76 ( 0.12 ) , 1.61 ( 0.37 ) , and 2.61 ( 0.46 ) h g/mL ; and AUC0 - was 0.79 ( 0.13 ) , 1.71 ( 0.46 ) , and 2.72 ( 0.50 ) h g/mL .
RESULTS	The ranges for tz , CL , and Vz were 5.19 to 5.98 hours , 4.73 to 5.44 mL/min/kg , and 2.23 to 0.58 L/kg , respectively .
RESULTS	The mean urinary recovery rate within 24 hours was 75.0 % ( 12.0 % ) , 65.0 % ( 19.2 % ) , and 66.4 % ( 14.1 % ) .
RESULTS	Men and women had significantly different AUC0-24 values in the 0.50-mg / kg dose group ( P = 0.044 ) , and Vz showed significant differences between men and women in all 3 dose groups ( P = 0.001 ) .
RESULTS	According to ECG parameters , PR intervals were significantly prolonged after administration at all 3 doses ( P = 0.034 , P < 0.001 , and P = 0.034 ) ; no significant changes were seen in QRS width , QTc interval , or other parameters .
CONCLUSIONS	Pilsicainide hydrochloride demonstrated linear PK , and the increase in the exposure of pilsicainide ( AUC0-24 and AUC0 - ) was dose proportional after single doses of 0.25 , 0.50 , and 0.75 mg/kg .
CONCLUSIONS	All 3 pilsicainide hydrochloride doses were well tolerated in these Chinese volunteers .
CONCLUSIONS	ChiCTR-ONC-13003546 .

###25699397
OBJECTIVE	Hyperthermia has long been used in combination with radiation for the treatment of cancers .
OBJECTIVE	This study aimed to investigate the efficacy safety and impact on the immune function of the abdominal hyperthermia combining with radiotherapy .
METHODS	Sixty-eight patients with post-operative local recurrent gastric carcinoma were divided randomly into two groups .
METHODS	Patients in 3DCRT + HT group received three-dimensional conformal radio therapy combined with abdominal hyperthermia while patients from 3DCRT group only received the three-dimensional conformal radiation therapy .
METHODS	The differences of efficacy , toxicity and the impact on immune function between two kinds of therapies were compared .
RESULTS	Response rate in 3DCRT + HT group was 57.2 % , which was significant higher than that in 3DCRT group ( 47.1 % ) ( P = 0.04 ) .
RESULTS	Median local progression-free survival time of 3DCRT + HT group ( 14 months ) was significantly longer than 3DCRT group ( 11 months ) .
RESULTS	The peripheral blood T lymphocyte subsets analyses showed that , after the treatment , CD3 + , CD4 + , NK level and CD4 + / CD8 + ratio increased significantly , while there was no significant alterations for those immunological parameters in 3DCRT group .
CONCLUSIONS	Abdominal hyperthermia combined with three-dimensional conformal radiotherapy could gain higher response rate , prolong median local progression-free survival time and improve immune function for the post-operative recurrentgastric cancer .

###24887336
OBJECTIVE	To compare the respiratory and circulatory parameters between intranasal and intravenous dexmedetomidine in gastroscopy .
METHODS	60 patients undergoing elective gastroscopy were randomly divided into group D1 and D2 .
METHODS	Dexmedetomidine ( 0.5 g/kg , 1 mL ) and normal saline ( NS , 1 mL ) were given by intranasal route 40 minutes before induction , and then NS ( 20 mL ) and dexmedetomidine ( 0.5 g/kg , 20 mL ) were given intravenously 10 minutes before induction , respectively , in groups D1 and D2 .
METHODS	Propofol ( 1.5 - 2 mg/kg ) was used for induction .
METHODS	Heart rate ( HR ) , mean arterial pressure ( MAP ) , pulse oxygen saturation ( SpO ) , and respiratory rate ( RR ) were monitored .
METHODS	The latent period of falling asleep , the duration of gastroscopy , the time of awakening , and the total dose of propofol consumption were also recorded .
METHODS	Postoperative sedation scale and adverse reactions were observed .
RESULTS	One patient in group D1 was excluded from the study due to atrioventricular block .
RESULTS	The HR and SpO were significantly lower , but RR was significantly higher in group D2 than in group D1 ( all p < 0.05 ) .
RESULTS	The time of awakening was significantly longer and the rates of respiratory depression were significantly higher in group D2 than in group D1 ( all p < 0.05 ) There were no significant differences in other parameters between both groups .
CONCLUSIONS	Intranasal dexmedetomidine is a new , safe , and effective approach for gastroscopy because it has more stable respiratory and circulatory parameters and less adverse reactions than intravenous dexmedetomidine .

###24656609
BACKGROUND	In the SELECT trial , disease activity was reduced in patients with multiple sclerosis who received daclizumab high-yield process ( HYP ) for 52 weeks .
BACKGROUND	The primary aim of the SELECTION extension study was to assess the safety and immunogenicity of extended treatment with daclizumab HYP .
METHODS	A multicentre , randomised , double-blind , 52-week extension trial was done in 74 centres in the Czech Republic , Germany , Hungary , India , Poland , Russia , Ukraine , and the UK between Feb 13 , 2009 , and Oct 3 , 2012 .
METHODS	Eligible patients were aged 18-55 years , had relapsing-remitting multiple sclerosis , and had completed the SELECT study .
METHODS	Patients who received placebo in SELECT were randomly assigned ( 1:1 ) to receive 150 mg or 300 mg subcutaneous daclizumab HYP every 4 weeks for 52 weeks ( treatment initiation group ) ; those who had received daclizumab HYP were randomly assigned ( 1:1 ) to continue their present dose with ( washout and re-initiation group ) or without ( continuous treatment group ) a washout period of 20 weeks .
METHODS	All randomisation was done with a centralised , interactive voice-response system .
METHODS	Patients and personnel were masked to treatment assignment , except for the site pharmacist who prepared the study drug but had no interaction with patients .
METHODS	The primary endpoints were the safety and immunogenicity of daclizumab HYP .
METHODS	Analyses were by intention to treat .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00870740 .
RESULTS	517 ( 91 % ) of 567 patients who completed the SELECT trial entered SELECTION , of whom 170 were in the treatment initiation group , 173 in the continuous treatment group , and 174 in the washout and re-initiation group .
RESULTS	11 patients in the treatment initiation group ( 6 % ) , 13 in the continuous treatment group ( 8 % ) , and ten in the washout and re-initiation group ( 6 % ) had any serious adverse event other than relapse of multiple sclerosis .
RESULTS	One patient in the washout and re-initiation group ( 300 mg daclizumab HYP ) died because of autoimmune hepatitis ; a contributory role of daclizumab HYP could not be excluded .
RESULTS	Seven patients tested positive for neutralising antidrug antibodies : one ( 1 % ) of 128 for whom data were available in the continuous treatment group ( this patient also tested positive at SELECTION baseline ) , four ( 2 % ) in the treatment initiation group , and two ( 2 % ) of 129 in the washout and re-initiation group .
CONCLUSIONS	Adverse events and immunogenicity were not increased in the second year of continuous treatment with daclizumab HYP or during treatment washout and re-initiation .
CONCLUSIONS	These results support further assessment of daclizumab HYP for relapsing-remitting multiple sclerosis .
BACKGROUND	Biogen Idec and AbbVie Biotherapeutics .

###24228710
BACKGROUND	2-Agonists are the treatment of choice for exercise-induced bronchoconstriction ( EIB ) and act through specific receptors ( ADRB2 ) .
BACKGROUND	Arg16Gly polymorphisms have been shown to affect responses to regular use of 2-agonists .
OBJECTIVE	To evaluate the influence of the Arg16Gly receptor polymorphism on salmeterol bronchoprotection in EIB and assess predictors of bronchoprotection .
METHODS	A prospective , genotype-blinded , randomized trial was performed in 26 subjects ( 12 Arg16Arg and 14 Gly16Gly ) with EIB who were not on controller therapy .
METHODS	Subjects were administered salmeterol , 50 g twice a day for 2 weeks , and underwent an exercise challenge 9 hours after the first and last drug dose .
METHODS	In addition to genotype , FEV1 , response to salmeterol , degree of EIB , and exhaled nitric oxide ( FE ( NO ) ) at baseline were examined for their association with loss of bronchoprotection ( LOB ) .
RESULTS	The maximum exercise-induced FEV1 fall was 27.9 1.4 % during the run-in period , 8.1 1.2 % ( 70.3 4.1 % bronchoprotection ) after the first salmeterol dose , and 22.8 3.2 % ( 18.9 11.5 % bronchoprotection ) after 2 weeks of salmeterol ( P = 0.0001 ) .
RESULTS	The Arg16Gly polymorphisms were not associated with the LOB in response to salmeterol .
RESULTS	FeNO values at baseline were significantly related to the LOB ( r = 0.47 ; P = 0.01 ) .
RESULTS	Mean change was a 74 13 % LOB in subjects with FE ( NO ) levels greater than 50 ppb and a 7 16 % gain in bronchoprotection in those with FE ( NO ) levels less than 25 ppb ( P = 0.01 ) .
CONCLUSIONS	The LOB that occurs with chronic long-acting 2-agonists use is not affected by ADRB2 Arg16Gly polymorphisms .
CONCLUSIONS	High FE ( NO ) was associated with marked LOB .
CONCLUSIONS	Use of long-acting 2-agonists before achieving a reduction in FeNO may need to be avoided .
CONCLUSIONS	Clinical trial registered with www.clinicaltrials.gov ( NCT 00595361 ) .

###24708672
BACKGROUND	Panic disorder and agoraphobia are debilitating and frequently comorbid anxiety disorders .
BACKGROUND	A large number of patients with these conditions are treated by general practitioners in primary care .
BACKGROUND	Cognitive behavioural exposure exercises have been shown to be effective in reducing anxiety symptoms .
BACKGROUND	Practice team-based case management can improve clinical outcomes for patients with chronic diseases in primary care .
BACKGROUND	The present study compares a practice team-supported , self-managed exposure programme for patients with panic disorder with or without agoraphobia in small general practices to usual care in terms of clinical efficacy and cost-effectiveness .
METHODS	This is a cluster randomised controlled superiority trial with a two-arm parallel group design .
METHODS	General practices represent the units of randomisation .
METHODS	General practitioners recruit adult patients with panic disorder with or without agoraphobia according to the International Classification of Diseases , version 10 ( ICD-10 ) .
METHODS	In the intervention group , patients receive cognitive behaviour therapy-oriented psychoeducation and instructions to self-managed exposure exercises in four manual-based appointments with the general practitioner .
METHODS	A trained health care assistant from the practice team delivers case management and is continuously monitoring symptoms and treatment progress in ten protocol-based telephone contacts with patients .
METHODS	In the control group , patients receive usual care from general practitioners .
METHODS	Outcomes are measured at baseline ( T0 ) , at follow-up after six months ( T1 ) , and at follow-up after twelve months ( T2 ) .
METHODS	The primary outcome is clinical severity of anxiety of patients as measured by the Beck Anxiety Inventory ( BAI ) .
METHODS	To detect a standardised effect size of 0.35 at T1 , 222 patients from 37 general practices are included in each group .
METHODS	Secondary outcomes include anxiety-related clinical parameters and health-economic costs .
BACKGROUND	Current Controlled Trials [ http://ISCRTN64669297] .

###25171662
OBJECTIVE	The aim of this study was to determine whether adherence to self-care modalities for breast cancer-related lymphedema ( BCRL ) predicts BCRL outcomes among 128 breast cancer survivors who participated in the 12-mo physical activity and lymphedema trial .
METHODS	This was a prospective cohort study .
METHODS	Adherence to ten BCRL self-care modalities , as recommended in the clinical practice guidelines for the management of BCRL , was assessed by a questionnaire at baseline .
METHODS	BCRL outcomes assessed at baseline and 12 mos included volumetry , circumferences , bioimpedence spectroscopy , the Norman lymphedema survey , and therapist-defined lymphedema exacerbations requiring treatment .
METHODS	Generalized linear models were used to estimate the relationship between adherence to BCRL self-care modalities and the likelihood of experiencing a BCRL outcome .
RESULTS	Adherence to BCRL self-care activities did not predict experiencing any BCRL outcomes at 12 mos .
RESULTS	Levels of adherence to BCRL self-care modalities did not predict a 5 % or greater decrease in interlimb volume ( Ptrend = 0.79 ) , 5 % or greater decrease in the sum of interlimb arm circumferences ( Ptrend = 0.47 ) , 10 % or greater decrease in bioimpedence spectroscopy ( Ptrend = 0.83 ) , 1 or greater decrease in self-reported lymphedema symptoms ( Ptrend = 0.91 ) , or therapist-defined lymphedema exacerbation requiring treatment ( Ptrend = 0.84 ) .
CONCLUSIONS	Our findings suggest that levels of BCRL self-care adherence do not predict BCRL outcomes among breast cancer survivors with stable lymphedema who were followed for 12 mos .

###25895054
OBJECTIVE	Electrocorticographic ( ECoG ) recordings from patients with medically intractable partial-onset seizures treated with a responsive neurostimulator system ( the RNS System ) that detects and stores physician-specified ECoG events provide a new data resource .
OBJECTIVE	Interpretation of these recordings has not yet been validated .
OBJECTIVE	The purpose was to evaluate the interrater interpretation of chronic ambulatory ECoG recordings obtained by the RNS System .
METHODS	Five pairs of five experts independently classified 7,221 ECoG recordings obtained from 128 patients with medically intractable partial seizures who participated in a randomized controlled trial of the safety and efficacy of the RNS System .
METHODS	ECoG detections -- `` long episodes '' or `` saturations '' -- were classified as `` seizures '' or `` not seizures '' based on a reference definition .
METHODS	Interrater agreement rates and kappa score reliabilities were calculated between rater pairs from the ECoG sample as a whole and within individual patients who had more than the median number of individual ECoG recordings .
RESULTS	The overall interrater agreement was 79 % , with a reliability = 0.57 ( moderate agreement ) .
RESULTS	Agreement between pairs of reviewers ranged from 0.69 to 0.85 .
RESULTS	Agreement rates were 94 % or better for 50 % of patients .
RESULTS	Only 25 % of patients had ECoG recordings agreement rates worse than 75 % .
RESULTS	ECoGs with mixed interpretations ( one reviewer `` seizure '' / the other -- `` not seizure '' ) consisted of periods of low amplitude activity that evolved in amplitude or periodic discharges near 2 Hz .
CONCLUSIONS	Although reliability as a whole was moderate , for the majority of patients , detections yielded highly reliably interpreted events of either electrographic seizures or nonictal epileptiform activity .

###25040643
OBJECTIVE	To assess nurse-midwife provision of early medical termination of pregnancy ( TOP ) in a high-resource setting where ultrasound examination for dating of pregnancy is part of the protocol .
METHODS	Randomised controlled equivalence trial .
METHODS	Out-patient family planning unit at a university hospital .
METHODS	Women seeking early medical TOP .
METHODS	A total of 1180 women were randomised , without any prior examination , to counselling , examination , and treatment by either nurse-midwife or gynaecologist .
METHODS	Ultrasound was performed in all cases by the allocated provider .
METHODS	The primary outcome was efficacy , defined as the successful completion of TOP without need for vacuum aspiration .
METHODS	Secondary outcomes were safety , defined as need for hospitalisation or blood transfusion , and acceptability , defined as preferred provider were the women to have a medical TOP in the future .
RESULTS	A total of 481 women in the nurse-midwife group and 457 women in the doctor group were available for the final analysis .
RESULTS	The effectiveness of provision of medical TOP by nurse-midwife providers was superior to that provided by doctors ( risk difference 1.6 % , 95 % confidence interval 0.2-3 .0 % , which was within the set margin of equivalence ) .
RESULTS	There were no significant differences in safety parameters .
RESULTS	Women examined and counselled by a nurse-midwife were significantly more likely ( P < 0.001 , 95 % confidence interval 0.308-0 .394 ) to prefer seeing a nurse-midwife for the consultation were they to have another medical TOP in the future .
CONCLUSIONS	These findings show that nurse-midwife provision of early medical TOP in a high-resource setting , where ultrasound is part of the protocol , is effective , and can be safely implemented with high acceptability among women .

###25308408
OBJECTIVE	To evaluate the advantageous anesthetic properties , such as the decrease of intraoperative analgesic requirement , time to extubation and recovery , and early postoperative pain , of dexmedetomidine used as hypotensive agent compared with nitroglycerin in orthognathic surgery .
METHODS	The authors implemented a prospective , single-blinded , randomized clinical trial .
METHODS	The sample was composed of healthy patients who were admitted for bimaxillary osteotomies and were assigned to 1 of 2 groups by a computer-generated random number and blinded to the group .
METHODS	Dexmedetomidine or nitroglycerin was used as the hypotensive drug for each group .
METHODS	All patients underwent hypotensive anesthesia and surgery according to standard protocol .
METHODS	Intraoperative amount of fentanyl , time to eye opening , time to follow basic verbal commands , time to extubation , early postoperative pain scores , and analgesics were recorded .
METHODS	Compared means were analyzed using the unpaired Student t test .
METHODS	A 2-sided statistical test was used .
METHODS	A P value less than .05 was considered significant .
RESULTS	The sample was composed of 40 participants .
RESULTS	The intraoperative fentanyl requirement was significantly lower in the dexmedetomidine group than in the nitroglycerin group ( 168.7556.29 and 222.5096.12 g , respectively ; P = .037 ) .
RESULTS	Times to eye opening and following commands were considerably longer in the dexmedetomidine group , but the time to extubation showed no meaningful difference .
RESULTS	Early postoperative pain after 30 and 60 minutes and the requirement for meperidine were not meaningfully different between the 2 groups .
CONCLUSIONS	Dexmedetomidine , used as a hypotensive drug , has anesthetic benefits compared with nitroglycerin .
CONCLUSIONS	Dexmedetomidine decreases the intraoperative fentanyl requirement and does not meaningfully change the time to extubation , early postoperative pain , and analgesic drug requirement .

###25345739
BACKGROUND	This article aims to assess the efficacy and safety of atomoxetine in Korean adults with attention-deficit hyperactivity disorder ( ADHD ) .
METHODS	This post hoc double-blind , placebo-controlled study of atomoxetine ( 40-120mg / day ) over 10 weeks in adults with ADHD at 45 Japanese , Korean , and Taiwanese study sites focused on patient data from Korea ( atomoxetine , n = 37 ; placebo , n = 37 ) .
METHODS	Primary efficacy outcome was change in baseline-to-endpoint Conners ' Adult ADHD Rating Scale-Investigator-rated : Screening Version ( CAARS-Inv : SV ) Total ADHD Symptoms score .
METHODS	Secondary efficacy outcomes included changes in Adult ADHD Quality of Life ( AAQoL ) total , Behavior Rating Inventory of Executive Function-Adult Version Self-Report ( BRIEF-A : Self-Report ) , and Clinical Global Impression-ADHD-Severity ( CGI-ADHD-S ) scale scores .
RESULTS	Atomoxetine-treated patients demonstrated a mean 18.9-point reduction in CAARS-Inv : SV total ADHD Symptoms score , compared with the 7.45-point reduction in placebo-treated patients ( P0 .01 ) .
RESULTS	Significantly greater improvement was found for atomoxetine versus placebo in CGI-ADHD-S ( P0 .01 ) , BRIEF-A : Self-Report global executive composite ( P0 .05 ) , and metacognition index ( P0 .01 ) executive function scores .
RESULTS	Nausea , decreased appetite , and dry mouth were reported with significantly greater frequency by atomoxetine-treated patients , and only one placebo-treated patient discontinued because of adverse event .
RESULTS	A 2.1-kg reduction in weight and a 7.5-beat / minute increase in pulse rate were observed in atomoxetine-treated patients .
CONCLUSIONS	These data support a significant benefit of 80 - to 120-mg once daily atomoxetine versus placebo for treatment of ADHD in adult Korean patients .
CONCLUSIONS	A high placebo response rate was observed in this adult Korean sample ; a higher discontinuation rate was also observed in atomoxetine-treated patients .
CONCLUSIONS	These observations warrant further investigation .

###25159085
OBJECTIVE	The present trial evaluated incorporation of bright light therapy in the treatment of chronic nonspecific back pain ( CNBP ) .
METHODS	A prospective , randomized , controlled , multicenter , open design with three parallel trial arms was used .
METHODS	Subjects received a novel therapeutic , an expected therapeutic ineffective low dose , or no light exposure at three different medical centers .
METHODS	A total of 125 CNBP patients reporting pain intensity of 3 points on item 5 of the Brief Pain Inventory ( BPI ) were included .
METHODS	Over 3 weeks , 36 active treatment , 36 placebo controls , and 33 controls received 3 or no supplementary light exposures of 5.000 lx or 230lx , respectively .
METHODS	Changes in self-reported scores of pain intensity ( BPI sub-score 1 ) and depression ( Hospital Anxiety and Depression Questionnaire ) were the primary outcome measures .
METHODS	Secondary outcome measures were changes in self-reported overall pain sensation ( BPI total score ) , grade of everyday life impairment ( BPI sub-score 2 ) , mood ( visual analog scale ) , and well-being ( World Health Organization-Five Well-Being Index ) .
RESULTS	Changes in pain intensity were higher ( 1.0 [ 0.8-1 .6 ] ) in the bright light group compared with controls ( 0.3 [ -0.1 -0.8 ] ; effect size D = 0.46 ) .
RESULTS	Changes in the depression score were also higher in the intervention group ( 1.5 [ 0.0-2 .5 ] ) compared with controls ( 0.0 [ 0.0-2 .0 ] ; effect size D = 0.86 ) .
RESULTS	No differences were seen in change scores between intervention vs sham group .
CONCLUSIONS	The present randomized controlled trial shows that light therapy even in low dose could improve depressive symptoms and reduce pain intensity in CNBP patients .
CONCLUSIONS	Further research is needed for optimizing parameters of frequency , dose , and duration of therapeutic light exposure .

###25357218
BACKGROUND	Osteopathy may decrease the severity of irritable bowel syndrome ( IBS ) .
BACKGROUND	About 35 % of patients with quiescent Crohn 's disease ( CD ) continue to suffer from IBS-like symptoms with impaired quality of life ( Qol ) .
BACKGROUND	We aimed to evaluate the effect of osteopathy on the severity of IBS-like symptoms in quiescent CD patients .
METHODS	We prospectively included 38 patients with CD on remission over 12 months while receiving infliximab every 8 weeks .
METHODS	Patients were randomized 2/1 to receive three sessions of standardized osteopathy ( n = 25 ) at 15 , 30 , and 45 days after the last infusion of infliximab or simple follow-up .
METHODS	The severity of IBS-like symptoms , psychological factors , and its impact on Qol were assessed using questionnaires .
RESULTS	Compared with baseline , the severity of IBS-like symptoms was significantly reduced in patients receiving osteopathy .
RESULTS	The decrease was significantly more pronounced in patients receiving osteopathy at day 30 [ -38.4 ( -76.1 to 10.2 ) vs. 32.2 ( -16.6 to 41.6 ) , P = 0.01 ] , day 45 [ -36.7 ( -74.4 to 25.3 ) vs. 32.2 ( -16.6 to 41.6 ) , P = 0.04 ] , and day 60 [ -39.5 ( -60.9 to -9.2 ) vs. 6.1 ( -38.7 to 28.5 ) , P = 0.05 ] with a concomitant increase in Qol ( P = 0.09 at day 30 , P = 0.02 at day 45 , P = 0.3 at day 60 ) .
RESULTS	Compared with baseline , the severity of fatigue was significantly reduced in patients receiving osteopathy , whereas depression and anxiety remained unchanged .
CONCLUSIONS	Three sessions of osteopathy reduced the severity of IBS-like symptoms associated with CD in remission .
CONCLUSIONS	Osteopathy should be viewed as a helpful therapeutic option to reduce the severity of abdominal pain and discomfort in patients with CD but in remission with IBS-like symptoms .

###24945513
OBJECTIVE	The aim of the present study was to evaluate the transverse effect of rapid maxillary expansion in patients with unilateral complete cleft lip and palate while comparing the Haas and Hyrax appliances .
METHODS	The sample consisted of 48 patients divided into two groups : Group I = 25 patients treated with modified Haas appliance ( mean age : 10 years and 8 months ) ; and Group II = 23 patients treated with Hyrax appliance ( mean age : 10 years and 6 months ) .
METHODS	Cast models were taken during pre-expansion and after removal of the appliance , at the end of the retention period .
METHODS	The models were scanned with the aid of the 3 Shape R700 3D scanner .
METHODS	Initial and final transverse distances were measured at cusp tips and cervical-palatal points of maxillary teeth by using the Ortho Analyzer 3D software .
RESULTS	The mean expansion obtained between cusp tips and between cervical-palatal points was , respectively : for inter-canine width , 4.80 mm and 4.35 mm with the Haas appliance and 5.91 mm and 5.91 mm with the Hyrax appliance ; as for first deciduous molars or first deciduous premolars , the values obtained were 6.46 mm and 5.90 mm in the Haas group , and 7.11 mm and 6.65 mm in the Hyrax group ; with regard to first molars , values were 6.11 mm and 5.24 mm in the Haas group , and 7.55 mm and 6.31 mm in the Hyrax group .
CONCLUSIONS	Rapid maxillary expansion significantly increased the transverse dimensions of the upper dental arch in patients with cleft palate , with no significant differences between the Hass and Hyrax expanders .

###24286509
BACKGROUND	Two replicate randomized , placebo-controlled six-month trials ( RCTs ) and an open-label treatment extension ( OLE ) comprised the pegloticase development program in patients with gout refractory to conventional therapy .
BACKGROUND	In the RCTs , approximately 40 % of patients treated with the approved dose saw complete response ( CR ) of at least one tophus .
BACKGROUND	Here we describe the temporal course of tophus resolution , total tophus burden in patients with multiple tophi , tophus size at baseline , and the relationship between tophus response and urate-lowering efficacy .
METHODS	Baseline subcutaneous tophi were analyzed quantitatively using computer-assisted digital images in patients receiving pegloticase ( 8 mg biweekly or monthly ) or placebo in the RCTs , and pegloticase in the OLE .
METHODS	Tophus response , a secondary endpoint in the trials , was evaluated two ways .
METHODS	Overall tophus CR was the proportion of patients achieving a best response of CR ( without any new/enlarging tophi ) and target tophus complete response ( TT-CR ) was the proportion of all tophi with CR .
RESULTS	Among 212 patients randomized in the RCTs , 155 ( 73 % ) had 1 tophus and 547 visible tophi were recorded at baseline .
RESULTS	Overall tophus CR was recorded in 45 % of patients in the biweekly group ( P = 0.002 versus placebo ) , 26 % in the monthly group , and 8 % in the placebo group after six months of RCT therapy .
RESULTS	TT-CR rates at six months were 28 % , 19 % , and 2 % of tophi , respectively .
RESULTS	Patients meeting the primary endpoint of sustained urate-lowering response to therapy ( responders ) were more likely than nonresponders to have an overall tophus CR at six months ( 54 % vs 20 % , respectively and 8 % with placebo ) .
CONCLUSIONS	Pegloticase reduced tophus burden in patients with refractory tophaceous gout , especially those achieving sustained urate-lowering .
CONCLUSIONS	Complete resolution of tophi occurred in some patients by 13 weeks and in others with longer-term therapy .
BACKGROUND	NCT00325195 , NCT01356498 .

###24776325
BACKGROUND	The present study was designed to determine the effect of short-term moderate-intensity exercise training on arterial stiffness in patients with chronic kidney disease ( CKD ) stage3 .
METHODS	Randomized controlled trial with a parallel-group design .
METHODS	Testing and training sessions were performed at Springfield College .
METHODS	46 ( treatment group , n = 25 ; control group , n = 21 ) patients with CKD with diabetes and/or hypertension completed the study .
METHODS	The aerobic training program consisted of 16 weeks of supervised exercise training at 50 % -60 % peak oxygen uptake ( Vo2peak ) 3 times per week , while the control group remained sedentary .
METHODS	Identical testing procedures were performed following the 16-week intervention .
RESULTS	The primary outcome was arterial stiffness .
RESULTS	Secondary outcomes were aerobic capacity , various blood parameters ( endothelin 1 , nitrate/nitrite , and high-sensitivity C-reactive protein ) , and health-related quality of life .
METHODS	Arterial stiffness was assessed with aortic pulse wave velocity ( PWV ) , aerobic capacity by Vo2peak , blood parameters by enzyme-linked immunosorbent assays , and health-related quality of life by the 36-Item Short Form Health Survey ( SF-36 ) .
METHODS	Participants attended 4 sessions before being randomly assigned to either the treatment or control group .
METHODS	Participants gave consent during the first session , whereas a graded exercise test with measurement of Vo2peak was completed during the second session .
METHODS	During sessions 3 and 4 , aortic PWV was measured at rest prior to 40 minutes of either moderate-intensity exercise training or seated rest .
METHODS	A venous blood sample was obtained prior to exercise or rest and participants completed the SF-36 questionnaire .
RESULTS	16 weeks of training led to an 8.2 % increase in Vo2peak for the treatment group ( P = 0.05 ) , but no changes in aortic PWV .
CONCLUSIONS	Randomization was not concealed and was violated on one occasion ; also , use of an indirect measurement of endothelial function and the short duration of the intervention .
CONCLUSIONS	Short-term moderate-intensity exercise training does not alter arterial stiffness in patients with CKD , but seems to reduce endothelin 1 levels .

###25615445
BACKGROUND	Treatment satisfaction of men receiving phosphodiesterase 5 inhibitors ( PDE5 ) for erectile dysfunction ( ED ) and their partners is essential to successful long-term therapy .
OBJECTIVE	This study aims to assess treatment satisfaction , in men with a partial response to on-demand ( PRN ) PDE5 and their female partners , following tadalafil 5mg once daily or placebo .
METHODS	The study was randomized , double-blind , parallel , and placebo-controlled in men primarily with mild to moderate ED .
METHODS	Treatment satisfaction was assessed following a 4-week maximum dose PRN lead-in , 4-week nondrug washout , and treatment through 12 weeks .
METHODS	Men were 18 years old with ED for 3 months and International Index of Erectile Function Erectile Function score of 17 and < 26 at screening and < 26 following PRN lead-in .
METHODS	Treatment satisfaction was assessed using the Treatment Satisfaction Scale ( TSS ) for patients and partners .
METHODS	TSS domain scores range from 0 to 100 , with higher values indicating greater satisfaction .
METHODS	Statistical comparisons were made using analysis of covariance .
RESULTS	Treatment satisfaction was significantly greater with tadalafil once daily vs. placebo across all TSS domains for both patients and their partners ( all P < 0.001 ) .
RESULTS	For patients , mean scores for the TSS domains Confidence to Complete Sexual Activity and Satisfaction with Orgasm ranged from 53.7 to 57.8 after the PRN lead-in and 26.7 to 31.9 following the nondrug washout .
RESULTS	Following randomized treatment , scores for tadalafil and placebo were 55.4 and 32.6 , respectively , for Confidence to Complete Sexual Activity and 57.5 and 37.9 , respectively , for Satisfaction with Orgasm .
RESULTS	Results were comparable for other TSS domains and between men and their partners .
CONCLUSIONS	Treatment satisfaction was comparable for tadalafil 5mg once daily and PRN PDE5 for both patients and female partners , suggesting that tadalafil once daily is a viable therapy option for men with ED who had a partial response to PRN PDE5 therapy .

###25584664
BACKGROUND	Despite recent declines among young children , obesity remains a public health burden in the United States , including among Latino/Hispanic children .
BACKGROUND	The determining factors are many and are too complex to fully address with interventions that focus on single factors , such as parenting behaviors or school policies .
BACKGROUND	In this article , we describe a multisector , multilevel intervention to prevent and control childhood obesity in predominantly Mexican-origin communities in Southern California , one of three sites of the CDC-funded Childhood Obesity Research Demonstration ( CA-CORD ) study .
METHODS	CA-CORD is a partnership between a university-affiliated research institute , a federally qualified health center , and a county public health department .
METHODS	We used formative research , advisory committee members ' recommendations , and previous research to inform the development of the CA-CORD project .
METHODS	Our theory-informed multisector , multilevel intervention targets improvements in four health behaviors : fruit , vegetable , and water consumption ; physical activity ; and quality sleep .
METHODS	Intervention partners include 1200 families , a federally qualified health center ( including three clinics ) , 26 early care and education centers , two elementary school districts ( and 20 elementary schools ) , three community recreation centers , and three restaurants .
METHODS	Intervention components in these sectors target changes in behaviors , policies , systems , and the social and physical environment .
METHODS	Evaluation activities include assessment of the primary outcome , BMI z-score , at baseline , 12 - , and 18-months post-baseline , and sector evaluations at baseline , 12 , and 24 months .
CONCLUSIONS	Identifying feasible and effective strategies to prevent and control childhood obesity has the potential to effect real changes in children 's current and future health status .

###24835497
BACKGROUND	Local anesthesia used for incision and drainage of abscesses is known to be painful .
OBJECTIVE	We studied the analgesia provided by a lidocaine/tetracaine patch compared to injectable lidocaine during incision and drainage ( I&D ) of skin abscesses .
METHODS	This was a prospective , double-blind , randomized , controlled trial carried out in the Emergency Department ( ED ) of an adult tertiary referral center .
METHODS	Adult patients with a skin abscess in need of I&D were randomized to one of two groups .
METHODS	One group received a lidocaine/tetracaine patch and injectable normal saline for anesthesia .
METHODS	The second group received a placebo patch and injectable1 % lidocaine .
METHODS	A visual analog pain scale was used to record the patient 's pain level prior to treatment , during the procedure , and after I&D .
RESULTS	There were 20 patients enrolled in the study , including 12 randomized to the lidocaine/tetracaine patch and 8 to the injectable lidocaine .
RESULTS	Pain scores preprocedure were similar in the two groups .
RESULTS	Pain scores during I&D and postprocedure were compared between groups using a paired t-test .
RESULTS	Patients receiving injectable lidocaine experienced pain that was similar ( 50.1 5.9 mm ; 95 % confidence interval [ CI ] 45.2-55 .1 ) to those receiving the transdermal lidocaine/tetracaine patch ( 60.1 mm 11.0 ; 95 % CI = 55.2-68 .1 ) , p = 0.04 , with a power of 80 % to detect a difference of 20 mm at p 0.05 ; although this was statistically significant , it was not clinically significant .
RESULTS	There was also no statistical difference between the two groups in the postprocedure pain scores ( p = 0.65 ) .
CONCLUSIONS	Local injection of lidocaine provided clinically similar analgesia compared to the lidocaine/tetracaine patch during I&D of skin abscesses in the ED .
CONCLUSIONS	Pain at presentation and after the procedure was similar in both groups .
CONCLUSIONS	Emergency physicians should continue to use a local injected anesthetic for I&D of skin abscesses until a less painful alternative is identified .

###25908001
OBJECTIVE	To evaluate the efficacy and safety of selective laser trabeculoplasty ( SLT ) as a replacement for medical therapy in primary open-angle glaucoma ( POAG ) .
METHODS	A prospective , randomized , controlled study.SLT treatment with SOLO SLT Nd : YAG laser was provided to 45 participants with advanced POAG ( 67 eyes , IOP 21 mmHg , 1 mmHg = 0.133 kPa ) under anti-glaucomatous medications control ) .
METHODS	A table of random numbers was created by simple randomization method .
METHODS	Participants were randomly divided into two groups : the standard-energy group ( 34 eyes ) , which received a 270 standard-energy SLT treatment and the sub-threshold energy group ( 33 eyes ) , which received a 360 sub-threshold energy treatment .
METHODS	The intraocular pressure ( IOP ) before and after SLT , daytime IOP curve , dosage of anti-glaucoma drugs and treatment complications were observed , which were be followed up for 6-9 months ( average 6.4 months ) .
METHODS	Two-tailed t-test or paired t test was used when the continuous variables were normal distribution , such as the basic data , daily fluctuations of IOP , laser energy .
METHODS	Non-parametric Mann-Whitney U test or Wilcoxon rank test was used when data was not distributed normally , such as drug category .
METHODS	Chi-square or Fisher 's exact test was used when count variables such as success rate and complications were analyzed .
RESULTS	The number of anti-glaucomatous drugs used in the standard-energy group and the sub-threshold energy group before SLT was ( 2.3 0.5 ) and ( 2.1 0.4 ) , respectively ; whereas , after the last treatment , it reduced to ( 1.3 0.5 ) and ( 1.1 0.3 ) , respectively ( Z = -5.477 , -5.396 ; P < 0.05 ) .
RESULTS	The success rate of the standard-energy group and the sub-threshold energy group was 91.1 % , and 87.9 % , respectively , which was not significant different ( P = 0.70 ) .
RESULTS	Laser treatment was found to reduce the IOP fluctuation during the daytime.IOP fluctuation decreased from ( 3.6 1.0 ) mmHg to ( 2.3 1.0 ) mmHg in the standard-energy group , and decreased from ( 3.9 1.4 ) mmHg to ( 2.4 0.9 ) mmHg in the sub-threshold energy group , which was significant different ( t = 4.911 , 4.679 ; P < 0.05 ) .
RESULTS	The total laser energy of the standard-energy group ( 47.8 6.0 ) mJ was higher than the sub-threshold energy group ( 43.2 5.1 ) mJ ( t = 12.006 , 3.233 ; P < 0.05 ) .
RESULTS	However , there was no significant difference in the daily IOP fluctuations , success rate , reduction of medication categories , preoperative and postoperative IOP , and adverse reactions between the two groups .
CONCLUSIONS	SLT is a safe and effective replacement for medical therapy in primary open-angle glaucoma treatment .
CONCLUSIONS	SLT could reduce the applications of anti-glaucoma drugs .
CONCLUSIONS	There was no significant difference between therapeutic effects of which eyes received 360 sub-threshold energy and 270 standard-energy .

###25395284
BACKGROUND	Aging results in a decline in the function of the respiratory muscles .
BACKGROUND	Inspiratory muscle training is emerging as a possible intervention to attenuate the decline of respiratory muscles in the elderly .
BACKGROUND	The aim of this study was to evaluate the efficacy of inspiratory muscle training on respiratory strength , diaphragm thickness , and diaphragmatic mobility in elderly women .
METHODS	This was a controlled , randomized , and double-blind clinical trial , performed on 22 elderly women distributed in two groups , training ( TG ) and control ( CG ) .
METHODS	Over an 8-week period a moderate intensity inspiratory muscle training protocol was followed in the TG , while CG followed a sham protocol .
METHODS	In addition maximum expiratory and inspiratory pressure , mobility of the diaphragm and diaphragmatic thickness were evaluated by ultrasound .
RESULTS	After training , in TG maximal inspiratory pressure , maximal expiratory pressure , diaphragm thickness , and mobility increased by 37 % , 13 % , 11 % , and 9 % respectively , and their values were significantly higher than CG ( p < .005 , p = .013 , p = .001 , and p = .001 ) .
CONCLUSIONS	Inspiratory muscle training of moderate intensity improves respiratory muscle strength , diaphragm thickness , and diaphragm mobility in elderly women and it should be considered to minimize changes associated with senescence .

###25105874
OBJECTIVE	Mobile technology can improve lifestyle programs , but the monitoring techniques and carer feedback need to be optimized .
OBJECTIVE	To this end , we investigated the efficacy of telemonitoring physical activity and nutrition over 12 months in patients with metabolic syndrome in a randomized , parallel-group , open trial .
METHODS	Screening all over Germany yielded 184 patients with metabolic syndrome .
METHODS	All patients attended a single 2-hour instruction meeting in their region concerning a combination diet and the importance of physical activity .
METHODS	Thereafter they were randomized into a control group ( controls , n = 62 ) or one of 2 different intervention groups .
METHODS	Both intervention groups were issued accelerometers , which measured physical activity , recorded daily weight and calorie intake , and transmitted these data to a central server for use by patient carers .
METHODS	In the Active Body Control Program of University of Magdeburg ( ABC ) intervention group ( n = 60 ) , information and motivation was ensured by weekly letters .
METHODS	In the 4sigma telephone coaching ( 4S ) intervention group ( n = 58 ) , this was accomplished by monthly telephone calls from the carers .
METHODS	Clinical and biochemical data for all patients were collected at 0 , 4 , 8 , and 12 months without any regular face-to-face meetings between patients and carers .
METHODS	The primary endpoint was weight loss and the secondary endpoint was the presence of metabolic syndrome .
RESULTS	After 12 months the dropout rates in the control , 4S , and ABC groups were respectively 35 % , 17 % , and 18 % .
RESULTS	The adjusted relative weight losses after 12 months were respectively 3.7 % , 8.6 % , and 11.4 % ( all p < 0.000 versus baseline ) .
RESULTS	ABC was more effective than 4S ( p = 0.041 ) ; 43 % of the patients completing the study in the ABC group lost more than 15 % of their baseline weight .
RESULTS	The diagnosis of metabolic syndrome was no longer applicable in 58 % of the cases in the ABC group , in 41 % of the 4S group , and in 33 % of the controls .
CONCLUSIONS	Telemonitoring of physical activity and nutrition markedly improves weight loss and markers of metabolic syndrome .

###24410954
OBJECTIVE	Little is known about the transfer of essential fatty acids ( FAs ) across the human blood-brain barrier ( BBB ) in adulthood .
OBJECTIVE	In this study , we investigated whether oral supplementation with omega-3 ( n-3 ) FAs would change the FA profile of the cerebrospinal fluid ( CSF ) .
METHODS	A total of 33 patients ( 18 receiving the n-3 FA supplement and 15 receiving placebo ) were included in the study .
METHODS	These patients were participants in the double-blind , placebo-controlled randomized OmegAD study in which 204 patients with mild Alzheimer 's disease ( AD ) received 2.3 g n-3 FA [ high in docosahexaenoic acid ( DHA ) ] or placebo daily for 6 months .
METHODS	CSF FA levels were related to changes in plasma FA and to CSF biomarkers of AD and inflammation .
RESULTS	At 6 months , the n-3 FA supplement group displayed significant increases in CSF ( and plasma ) eicosapentaenoic acid ( EPA ) , DHA and total n-3 FA levels ( P < 0.01 ) , whereas no changes were observed in the placebo group .
RESULTS	Changes in CSF and plasma levels of EPA and n-3 docosapentaenoic acid were strongly correlated , in contrast to those of DHA .
RESULTS	Changes in DHA levels in CSF were inversely correlated with CSF levels of total and phosphorylated tau , and directly correlated with soluble interleukin-1 receptor type II .
RESULTS	Thus , the more DHA increased in CSF , the greater the change in CSF AD/inflammatory biomarkers .
CONCLUSIONS	Oral supplementation with n-3 FAs conferred changes in the n-3 FA profile in CSF , suggesting transfer of these FAs across the BBB in adults .

###26028407
BACKGROUND	Patients with advanced squamous-cell non-small-cell lung cancer ( NSCLC ) who have disease progression during or after first-line chemotherapy have limited treatment options .
BACKGROUND	This randomized , open-label , international , phase 3 study evaluated the efficacy and safety of nivolumab , a fully human IgG4 programmed death 1 ( PD-1 ) immune-checkpoint-inhibitor antibody , as compared with docetaxel in this patient population .
METHODS	We randomly assigned 272 patients to receive nivolumab , at a dose of 3 mg per kilogram of body weight every 2 weeks , or docetaxel , at a dose of 75 mg per square meter of body-surface area every 3 weeks .
METHODS	The primary end point was overall survival .
RESULTS	The median overall survival was 9.2 months ( 95 % confidence interval [ CI ] , 7.3 to 13.3 ) with nivolumab versus 6.0 months ( 95 % CI , 5.1 to 7.3 ) with docetaxel .
RESULTS	The risk of death was 41 % lower with nivolumab than with docetaxel ( hazard ratio , 0.59 ; 95 % CI , 0.44 to 0.79 ; P < 0.001 ) .
RESULTS	At 1 year , the overall survival rate was 42 % ( 95 % CI , 34 to 50 ) with nivolumab versus 24 % ( 95 % CI , 17 to 31 ) with docetaxel .
RESULTS	The response rate was 20 % with nivolumab versus 9 % with docetaxel ( P = 0.008 ) .
RESULTS	The median progression-free survival was 3.5 months with nivolumab versus 2.8 months with docetaxel ( hazard ratio for death or disease progression , 0.62 ; 95 % CI , 0.47 to 0.81 ; P < 0.001 ) .
RESULTS	The expression of the PD-1 ligand ( PD-L1 ) was neither prognostic nor predictive of benefit .
RESULTS	Treatment-related adverse events of grade 3 or 4 were reported in 7 % of the patients in the nivolumab group as compared with 55 % of those in the docetaxel group .
CONCLUSIONS	Among patients with advanced , previously treated squamous-cell NSCLC , overall survival , response rate , and progression-free survival were significantly better with nivolumab than with docetaxel , regardless of PD-L1 expression level .
CONCLUSIONS	( Funded by Bristol-Myers Squibb ; CheckMate 017 ClinicalTrials.gov number , NCT01642004 . )

###25066876
OBJECTIVE	To assess same-day and delayed reports of pain intensity during and after second-trimester medical termination of pregnancy ( MTOP ) .
METHODS	A prospective randomized trial ( 217 women ) comparing 1 - and 2-day mifepristone-misoprostol intervals .
RESULTS	Women reported intense pain [ median visual analogue scale ( interquartile range ) ] related to expulsion of the fetus [ 6 ( 0-10 ) ] .
RESULTS	Delayed reports of maximal pain described the pain as more intense than same-day reports [ 8 ( 3-10 ) vs. 7 ( 1-10 ) , p < .001 ] .
CONCLUSIONS	Most women reported and readily remembered intense pain associated with fetal expulsion during second-trimester MTOP .
CONCLUSIONS	Adequate , properly timed pain management during second-trimester MTOP is crucial .

###24272224
OBJECTIVE	To determine the effect of reduced 80-kV tube voltage with increased 370-mAs tube current on radiation dose , image quality and estimated myocardial blood flow ( MBF ) of dynamic CT stress myocardial perfusion imaging ( CTP ) in patients with a normal body mass index ( BMI ) compared with a 100-kV and 300-mAs protocol .
METHODS	Thirty patients with a normal BMI ( < 25 kg/m ( 2 ) ) with known or suspected coronary artery disease underwent adenosine-stress dual-source dynamic CTP .
METHODS	Patients were randomised to 80-kV/370-mAs ( n = 15 ) or 100-kV/300-mAs ( n = 15 ) imaging .
METHODS	Maximal enhancement and noise of the left ventricular ( LV ) cavity , contrast-to-noise ratio ( CNR ) and MBF of the two groups were compared .
RESULTS	Imaging with 80-kV/370-mAs instead of 100-kV/300-mAs was associated with 40 % lower radiation dose ( mean dose-length product , 35966 vs 628112 mGy [ Symbol : see text ] cm ; P < 0.001 ) with no significant difference in CNR ( 34.513.4 vs 33.510.4 ; P = 0.81 ) or MBF in non-ischaemic myocardium ( 0.950.20 vs 0.990.25 ml/min/g ; P = 0.66 ) .
RESULTS	Studies obtained using 80-kV/370-mAs were associated with 30.9 % higher maximal enhancement ( 804204 vs 614115 HU ; P < 0.005 ) , and 31.2 % greater noise ( 22.73.5 vs 17.42.6 ; P < 0.001 ) .
CONCLUSIONS	Dynamic CTP using 80-kV/370-mA instead of 100-kV/300-mAs allowed 40 % dose reduction without compromising image quality or MBF .
CONCLUSIONS	Tube voltage of 80-kV should be considered for individuals with a normal BMI .
CONCLUSIONS	CT stress perfusion imaging ( CTP ) is increasingly used to assess myocardial function .
CONCLUSIONS	Dynamic CTP is feasible at 80-kV in patients with normal BMI .
CONCLUSIONS	An 80-kV/370-mAs protocol allows 40 % dose reduction compared with 100-kV/300-mAs .
CONCLUSIONS	Contrast-to-noise ratio and myocardial blood flow of the two protocols were comparable .

###24575806
OBJECTIVE	Cow 's milk protein allergy ( CMPA ) is treated using an elimination diet with an extensive protein hydrolysate .
OBJECTIVE	We explored whether a thickened or nonthickened version was best for infants with suspected CMPA , which commonly causes regurgitation/vomiting .
METHODS	Diagnosis of CMPA was based on a positive challenge test .
METHODS	We compared the efficacy of two casein extensive hydrolysates ( eCH ) , a nonthickened version ( NT-eCH ) and a thickened version ( T-eCH ) , using a symptom-based score covering regurgitation , crying , stool consistency , eczema , urticarial and respiratory symptoms .
RESULTS	A challenge was performed in 52/72 infants with suspected CMPA and was positive in 65.4 % .
RESULTS	All confirmed CMPA cases tolerated eCH .
RESULTS	The symptom-based score decreased significantly in all infants within a month , and the highest reduction was in those with confirmed CMPA .
RESULTS	Regurgitation was reduced in all infants ( 6.43.2-2 .82.9 , p < 0.001 ) , but fell more with the T-eCH ( -4.23.2 regurgitations/day vs. -3.04.5 , ns ) , especially in infants with a negative challenge ( -3.94.0 vs. -1.93.4 , ns ) .
CONCLUSIONS	eCH fulfilled the criteria for a hypoallergenic formula , and the NT-eCH and T-eCH formulas both reduced CMPA symptoms .
CONCLUSIONS	The symptom-based score is useful for evaluating how effective dietary treatments are for CMPA .

###24892115
OBJECTIVE	The treatment of gingival inflammation is associated with improved glycaemic control in diabetic patients .
OBJECTIVE	The goal of this parallel-randomised controlled trial ( RCT ) was to test the shortterm effects of professional oral hygiene procedures on plasma glucose levels in systemically healthy individuals .
METHODS	Systemically healthy individuals with gingivitis and no sign of periodontitis were enrolled at a private practice in Italy .
METHODS	Patients were randomised to either a 1 hour ( h ) session of professional oral hygiene procedures or to 1 h in the waiting room .
METHODS	Not fasting blood glucose levels were assessed by a blind examiner at baseline ( T0 ) , 1 h ( T1 ) and 2 h ( T2 ) after procedures and finally 1 week after ( T3 ) .
METHODS	Oral hygiene procedures were then performed also in the control group .
RESULTS	Twenty patients were randomly allocated to each group .
RESULTS	There were no drop-outs .
RESULTS	Blood glucose levels at T0 ( P = 0.0001 ) and time of measurement ( P = 0.0001 ) were statistically significant , while oral hygiene procedures were not ( mean difference between groups 0.77 mg/dl , 95 % CI -2.64 mg/dl ; 4.18 mg/dl , P = 0.6581 ) .
RESULTS	Mean blood glucose levels decreased between T0 and T1 , were stable between T1 and T2 and showed similar levels to baseline after 1 week ( T3 ) for both groups .
CONCLUSIONS	This short-term RCT showed that professional oral hygiene procedures were not able to influence plasma glucose levels in individuals with gingivitis , but otherwise systemically healthy .

###24686513
OBJECTIVE	The aim of the study was to extend research on the potential benefits of adding ongoing feedback , coaching , and consultation to initial therapist training workshops to ensure fidelity of delivery of evidence-based practices , specifically for the Incredible Years parenting program .
METHODS	A randomized controlled trial compared two models for training therapists to deliver the parenting program for children at high risk of developing conduct problems .
METHODS	Therapists ( N = 56 ) from ten community-based mental health service organizations in California were trained in either a three-day workshop model ( N = 25 ) , based on active , experiential , self-reflective , principle-based learning , video modeling , and manuals , or an enhanced training model ( N = 31 ) that included all elements of the workshop model plus ongoing expert coaching , video review of and feedback on group sessions , and consultation for therapists and agency supervisors .
RESULTS	Overall fidelity across both conditions was rated > 3 on a 5-point scale in seven of eight domains measured .
RESULTS	Therapists in the condition that received ongoing coaching and consultation were significantly stronger in four of the domains : practical support , collaboration , knowledge , and skill at mediating vignettes .
CONCLUSIONS	Consultation and expert coaching for training therapists beyond the standard three-day training enhanced skills and therapists ' adherence to the model .

###24529119
OBJECTIVE	It is unclear if a modest reduction in dietary salt intake has beneficial effects on vascular function .
OBJECTIVE	The aim was to compare the effects of 9 g salt/day with 6 g salt/day intake on measures of vascular function and explore mechanisms of effect in overweight and obese adults .
METHODS	Twenty-five overweight/obese subjects ( BMI 27-40 kg/m ( 2 ) ) completed a randomised cross-over study of 6 weeks each on a reduced salt ( RS ) ( 6 g/day ) and usual salt diet ( US ) ( 9 g/day ) .
METHODS	Flow-mediated-dilatation ( FMD ) , 24 h blood pressure ( BP ) , augmentation index ( AIx ) , pulse wave velocity ( PWV ) , plasma and urinary nitrate/nitrite , asymmetric dimethylarginine ( ADMA ) , renin , aldosterone and endothelin-1 and vascular adhesion molecules were measured after 2 days and 6 weeks .
METHODS	Adherence to the diets was determined from two 24 h urine collections .
RESULTS	Urinary sodium excretion was 155 58 mmol/24 h US vs 113 45 mmol/24 h RS ( p = 0.002 ) .
RESULTS	Following the RS diet there was a significant improvement in FMD from 3.5 2.8 % to 5.6 2.8 % ( P < 0.001 ) and decrease in serum endothelin-1 from 1.45 0.38 pg/ml to 1.25 0.39 pg/ml ( P < 0.05 ) .
RESULTS	Endothelium-independent vasodilatation was also significantly different between treatments ( P < 0.05 ) .
RESULTS	AIx , PWV , serum ADMA and plasma and urinary nitrate/nitrite concentrations were not different between treatments .
RESULTS	Change in FMD was related to the urinary sodium : creatinine ratio ( r = -0.47 , P < 0.05 ) and was independent of blood pressure .
RESULTS	Aldosterone and renin were unchanged .
CONCLUSIONS	A small reduction in dietary salt intake of 3 g/day improves endothelial function in normotensive overweight and obese subjects .
CONCLUSIONS	This response may be mediated by serum endothelin-1 .
CONCLUSIONS	This small reduction in salt had no effect on aldosterone and renin concentrations .
CONCLUSIONS	This trial was registered with the Australian and New Zealand Clinical Trials Registry Unique Identifier : ACTRN12609000321246 http://www.anzctr.org.au/ACTRN12609000321246.aspx .

###24617449
OBJECTIVE	To evaluate the potential of antimicrobial photodynamic therapy ( aPDT ) as an adjunct to scaling and root planing ( SRP ) in the treatment of chronic periodontitis .
METHODS	In a single-centred randomized and controlled clinical trial , 90 patients ( 51 females and 39 males ) with untreated chronic periodontitis were randomly assigned to receive SRP with aPDT ( test group ) or SRP alone ( control group ) .
METHODS	Clinical parameters and halitosis were recorded for 6months after treatment by a periodontist who was blinded to the procedure .
RESULTS	Inter-group and intra-group statistical analyses were performed .
RESULTS	Significant difference between the two groups with respect to each variable was assessed using non-parametric Rank Order ancova .
RESULTS	Probing pocket depth and clinical attachment levels showed statistically significant reduction in the test group on evaluation at 3months and 6months as compared to the control group ( p < 0.05 ) .
RESULTS	A statistically significant improvement in gingival index and gingival bleeding index was seen for the test group after 2weeks and 1month of aPDT ( p < 0.01 ) , whereas the improvement in gingival index and gingival bleeding index at 3months and in plaque index at 2weeks after aPDT was less ( p < 0.05 ) .
RESULTS	Also , a significant difference was detected for the test group at 1month in terms of halitosis ( p < 0.05 ) , which did not persist for long .
CONCLUSIONS	Antimicrobial photodynamic therapy acts as a beneficial adjunct to SRP in non-surgical treatment and management of chronic periodontitis in short-term .
CONCLUSIONS	Further studies are required to assess the long-term effectiveness of aPDT .

###24500507
OBJECTIVE	To evaluate weight retention 12 months postpartum and factors associated among women who had received prenatal care at Health Care Centers in Porto Alegre , southern Brazil .
METHODS	Pregnant women in the last trimester were identified at 20 Health Care Centers .
METHODS	Socioeconomic , demographic and anthropometrics data were obtained .
METHODS	Six and 12 months after delivery , the women received home visits for anthropometric measures .
METHODS	The gestational weight gain was defined by pre-pregnancy Body Mass Index ( BMI ) .
METHODS	Weight retention was defined as the difference between pre-gestational weight and weight at postpartum .
METHODS	Data were analyzed using McNemar 's Test , ANOVA with Bonferroni correction and multiple linear regression .
RESULTS	Of the 715 pregnant women recruited , 545 were assessed 12 months after delivery .
RESULTS	Women were more likely to be overweight 12 months postpartum compared to the pre-pregnancy period ( 52.9 versus 36.7 % ) and weight retention during the 12 months postpartum was more than 10 kg in 30.7 % of the women .
RESULTS	Weight retention in the postpartum period was higher among women who were overweight ( 9.9 7.7 kg ) compared to those who were of normal weight during the pre-pregnancy period ( 7.6 6.2 kg ) .
RESULTS	Pre-pregnancy BMI , gestational weight gain , and maternal age were associated with gestational weight retention 12 months postpartum ( p < 0.001 ) .
CONCLUSIONS	Adequate prenatal care is necessary to minimize the adverse effects of excessive weight gain during pregnancy on women 's health .

###24565457
BACKGROUND	Few anaphylaxis education materials have been prospectively evaluated in randomized controlled trials .
OBJECTIVE	Our objective was to evaluate the American Academy of Allergy , Asthma & Immunology Anaphylaxis Wallet Card ( AAAAI-AWC ) as an anaphylaxis education mini-handout for health care professionals .
METHODS	We performed a randomized controlled study of the AAAAI-AWC with residents in general pediatrics at Miami Children 's Hospital .
METHODS	Participants in the intervention group completed a pretest about anaphylaxis , heard a 3-minute PowerPoint presentation based on the AAAAI-AWC , reviewed the AAAAI-AWC , and discussed it with the presenter .
METHODS	After this , participants took a post-test immediately and a follow-up test 4 weeks later .
METHODS	Participants in the control group took the pretest , were handed an AAAAI-AWC , studied it briefly , then took the post-test immediately and the follow-up test 4 weeks later .
RESULTS	Fifty-five residents participated .
RESULTS	Regardless of the amount of time spent studying the AAAAI-AWC , when the pretests were compared with the post-tests and follow-up tests , residents in both the intervention and control groups were more likely to recognize anaphylaxis symptoms ( P < .05 ) , name asthma as the most common comorbid disease in children with fatal or near-fatal anaphylaxis ( P < .05 ) , and recall the names of epinephrine auto injectors ( P < .05 ) and the epinephrine doses available in these auto injectors ( P < .05 ) .
RESULTS	When the pretests were compared with the post-tests and the follow-up tests , residents in the intervention group were more likely than controls to identify the body organ systems involved in severe or fatal anaphylaxis correctly ( P < .05 ) .
CONCLUSIONS	The AAAAI-AWC is a practical , concise anaphylaxis education mini-handout for pediatric residents , a time-challenged group of health care professionals .

###25194450
OBJECTIVE	To investigate whether functionally based resistance exercise could improve strength , physical function , and disability among prostate cancer survivors ( PCS ) on androgen deprivation therapy ( ADT ) ; and to explore potential mediators of changes in outcomes from exercise .
METHODS	Randomized controlled trial .
METHODS	Academic medical center .
METHODS	PCS ( N = 51 ; mean age , 70.2 y ) on ADT .
METHODS	PCS were randomized to moderate to vigorous intensity resistance training or stretching ( placebo control ) for 1 year .
METHODS	Maximal leg press and bench press strength , objective and self-reported physical function , and self-reported disability .
METHODS	Hierarchical linear modeling was used to test for significant group time differences adjusting for covariates .
RESULTS	Retention in the study was 84 % , and median attendance to supervised classes was 84 % in the resistance group .
RESULTS	No study-related injuries occurred .
RESULTS	Maximal leg strength ( P = .032 ) and bench press strength ( P = .027 ) were improved after 1 year of resistance training , whereas little change occurred from stretching .
RESULTS	Self-reported physical function improved with resistance training , whereas decreases occurred from stretching ( P = .016 ) .
RESULTS	Disability lessened more with resistance training than stretching ( P = .018 ) .
RESULTS	One-year change in leg press strength mediated the relation between groups ( resistance or stretching ) and 1-year change in self-reported disability ( P < .05 ) .
CONCLUSIONS	One year of resistance training improved muscle strength in androgen-deprived PCS .
CONCLUSIONS	Strengthening muscles using functional movement patterns may be an important feature of exercise programs designed to improve perceptions of physical function and disability .
CONCLUSIONS	Findings from this study contribute to the mounting evidence that exercise should become a routine part of clinical care in older men with advanced prostate cancer .

###24521036
BACKGROUND	Few studies have assessed associations between craving and subsequent opioid use .
BACKGROUND	We prospectively evaluated the relative utility of two craving questionnaires to predict opioid use among opioid-dependent patients in outpatient treatment .
METHODS	Opioid-dependent patients ( n = 147 ) initiating buprenorphine treatment were assessed every two weeks for 3 months .
METHODS	Craving was measured using the : ( 1 ) Desires for Drug Questionnaire ( DDQ ) and ( 2 ) Penn Alcohol-Craving Scale adapted for opioid craving ( PCS ) .
METHODS	Multi-level logistic regression models estimated the effects of craving on the likelihood of opioid use .
METHODS	Craving assessed at time t was entered as a time-varying predictor of opioid use at time t +1 .
RESULTS	Craving scores plateaued at approximately 2 weeks after initiation of buprenorphine .
RESULTS	In adjusted regression models , a 1-point increase in PCS scores ( on a 7-point scale ) was associated with a significant increase in the odds of opioid use at the subsequent assessment ( OR = 1.27 , 95 % CI 1.08 ; 1.49 , p < 0.01 ) .
RESULTS	The odds of opioid use at the subsequent follow-up assessment increased significantly as DDQ desire and intention scores increased ( OR = 1.25 , 95 % CI 1.03 ; 1.51 , p < 0.05 ) , but was not significantly associated with DDQ negative reinforcement ( OR = 1.01 , 95 % CI 0.88 ; 1.17 , p > 0.05 ) or DDQ control ( OR = 0.97 , 95 % CI 0.85 ; 1.11 , p > 0.05 ) scores .
CONCLUSIONS	Self-reported craving for opioids was modestly associated with subsequent relapse to opioid use among a cohort of patients treated with buprenorphine .
CONCLUSIONS	Assessment of craving may provide clinical utility in predicting relapse among treated opioid-dependent patients .

###25789594
OBJECTIVE	Neurotoxic metabolites and oxidative and nitrosative stress reactions play a crucial role in the pathways leading to neuronal cell death and neurodegeneration .
OBJECTIVE	The bioavailability of the many antioxidant ingredients a vitamin and trace element composition was investigated , to reveal the neuroprotective ( preventive ) potential of the composition .
METHODS	We recruited 159 healthy volunteers , assigned them randomly and double blind to a placebo and verum group .
METHODS	Physicians excluded volunteers with severe chronic diseases or interfeering medications .
METHODS	142 participants finished the six month trial .
METHODS	Laboratory parameters were determined 1 ) before participation , and 2 ) after three and 3 ) six months .
METHODS	We confirmed the bioavailability of ingredients , and determined metabolic parameters associated with the integrity of the blood brain barrier , mitochondrial deficiency ( Q 10 ) , neurodegeneration ( homocystein ) , and antioxidative capacity ( e.g. lipidperoxidation ) , and superoxiddismutase activity .
RESULTS	Starting from baseleine , after three months neuroprotective ingredients increased within their physiological borders , folic acid ( p < 0.003 ) , pyridoxin ( p < 0.001 ) , cobalamin ( p = 0.001 ) , and the fat soluble vitamin tocopherol ( p < 0.001 ) .
RESULTS	In parallel , homocytein decreased after 3 and 6 months ( p < 0.001 , and p < 0.025 , respectively ) .
RESULTS	Other paramters like zinc reacted slower , significant changes were observed only after 6 months .
CONCLUSIONS	The observed metabolic changes and alteration of the oxidative status after 3 and six month of regular intake underlines the compositions ' potential to ameliorate neurodegenerative processes .
CONCLUSIONS	We conclude that the subsitution of vitamins and trace-elements with natural source in a proper manner may be effective for neuroprotection in healthy population .

###24531357
OBJECTIVE	Weakness in knee flexion following anterior cruciate ligament ( ACL ) reconstruction is one of the key issues in the treatment of an ACL tear .
OBJECTIVE	The purpose of this study was to examine and compare clinical outcome measures of ACL reconstruction using semitendinosus autograft ( ST ) versus semitendinosus + gracilis ( ST/G ) reconstructive techniques .
METHODS	In a double-blind randomized clinical study , 19 patients with an ACL tear underwent either ST ( 59 ) or ST/G ( 61 ) and observed for 1year .
METHODS	Both patients and the final examiner were unaware as to the type of graft received .
METHODS	Patients were evaluated according to subjective criteria , functional assessment tests , knee isometric torques , knee laxity using KT-2000 and knee range of motion .
RESULTS	The study included 21 ( 17.6 % ) female and 99 ( 82.4 % ) male patients with a mean age of 29.97.8 in the ST group and 32.46.3 in the ST/G group .
RESULTS	There were no significant differences found in surgical complications ; IKD ; Knee injury and Osteoarthritis Outcome Score ; Lysholm ; strength of the knee isometric flexors ; and flexion and extension loss between the two groups .
RESULTS	At the final visit , 86.9 % of ST group and 89.6 % of ST/G group had side-to-side difference of laxity < 3mm ( n.s. ) .
CONCLUSIONS	Since anterior cruciate ligament reconstruction using quadrupled ST is more technically demanding than doubled STG and with there being no difference in outcomes and complications , no compulsory advice should be made on the former technique .
CONCLUSIONS	However , gracilis harvesting may not be necessary based on the function and strength of the knee .
METHODS	Randomized controlled trial , Level I.

###25240556
OBJECTIVE	To evaluate whether wearing a wool cap , a routine practice used to prevent heat loss in premature infants , affects interpretation of electroencephalogram spectral analysis .
METHODS	Eighteen premature infants ( median gestational age 28 weeks , range 23-32 ) without neurological complications were randomized to two channel ( C3 , C4 referred to Cz ) digital electroencephalogram recordings with ( 90 min ) and without ( 90 min ) wearing wool cap , at 4 days of life .
METHODS	Electroencephalogram was analyzed automatically by measurement of burst suppression ratio and asymmetry index and by Fast Fourier Transform to calculate total absolute spectral power ; relative spectral power in the ( 0.5-3 .5 Hz ) , ( 4-7 .5 Hz ) , ( 8-12 .5 Hz ) , and ( 13-30 Hz ) frequency bands ; spectral edge frequency ; and mean dominant frequency .
RESULTS	The use of wool cap had no effect on all electroencephalogram parameters considered .
RESULTS	Gestational age showed an effect on relative spectral power of all considered bands , spectral edge frequency and mean dominant frequency , while no effect was seen on burst suppression ratio and asymmetry index .
RESULTS	Neonates born at gestational weeks lower than 28 had significantly higher relative power in the band and lower relative power in the and bands .
CONCLUSIONS	Heat loss prevention using wool cap does not affect interpretation of spectral electroencephalogram .
CONCLUSIONS	Spectral values in our group of very premature infants without neurological complications correspond to normal data reported in the literature .
CONCLUSIONS	Maturation changes consist of reduction of relative power of the band , spectral edge frequency and mean dominant frequency .

###24716466
BACKGROUND	There is a high prevalence of smoking and high burden of tobacco-related diseases among low-income populations .
BACKGROUND	Effective , evidenced-based smoking cessation treatments are available , but low-income smokers are less likely than higher-income smokers to use these treatments , especially the most comprehensive forms that include a combination of pharmacotherapy and intensive behavioral counseling .
METHODS	The primary objectives of this randomized controlled trial are to compare the effects of a proactive tobacco treatment intervention compared to usual care on population-level smoking abstinence rates and tobacco treatment utilization rates among a diverse population of low-income smokers , and to determine the cost-effectiveness of proactive tobacco treatment intervention .
METHODS	The proactive care intervention systematically offers low-income smokers free and easy access to evidence-based treatments and has two primary components : ( 1 ) proactive outreach to current smokers in the form of mailed invitation materials and telephone calls containing targeted health messages , and ( 2 ) facilitated access to free , comprehensive , evidence-based tobacco cessation treatments in the form of NRT and intensive , telephone-based behavioral counseling .
METHODS	The study aims to include a population-based sample ( N = 2500 ) of adult smokers enrolled in the Minnesota Health Care Programs ( MHCP ) , a state-funded health insurance plan for low-income persons .
METHODS	Baseline data is obtained from MHCP administrative databases and a participant survey that is conducted prior to randomization .
METHODS	Outcome data is collected from a follow-up survey conducted 12months after randomization and MHCP administrative data .
METHODS	The primary outcome is six-month prolonged smoking abstinence at one year and is assessed at the population level .
METHODS	All randomized individuals are asked to complete the follow-up survey , regardless of whether they participated in tobacco treatment .
METHODS	Data analysis of the primary aims will follow intent-to-treat methodology .
CONCLUSIONS	There is a critical need to increase access to effective tobacco dependence treatments .
CONCLUSIONS	This randomized trial evaluates the effects of proactive outreach coupled with free NRT and telephone counseling on the population impact of tobacco dependence treatment .
CONCLUSIONS	If proven to be effective and cost-effective , national dissemination of proactive treatment approaches would reduce tobacco-related morbidity , mortality , and health care costs for low income Americans .
BACKGROUND	ClinicalTrials.gov : NCT01123967 .

###25217464
BACKGROUND	Angina affects more than 50 million people worldwide .
BACKGROUND	Secondary prevention interventions such as cardiac rehabilitation are not widely available for this population .
BACKGROUND	An Internet-based version could offer a feasible alternative .
OBJECTIVE	Our aim was to examine the effectiveness of a Web-based cardiac rehabilitation program for those with angina .
METHODS	We conducted a randomized controlled trial , recruiting those diagnosed with angina from general practitioners ( GPs ) in primary care to an intervention or control group .
METHODS	Intervention group participants were offered a 6-week Web-based rehabilitation program ( `` ActivateYourHeart '' ) .
METHODS	The program was introduced during a face-to-face appointment and then delivered via the Internet ( no further face-to-face contact ) .
METHODS	The program contained information about the secondary prevention of coronary heart disease ( CHD ) and set each user goals around physical activity , diet , managing emotions , and smoking .
METHODS	Performance against goals was reviewed throughout the program and goals were then reset/modified .
METHODS	Participants completed an online exercise diary and communicated with rehabilitation specialists through an email link/synchronized chat room .
METHODS	Participants in the control group continued with GP treatment as usual , which consisted of being placed on a CHD register and attending an annual review .
METHODS	Outcomes were measured at 6-week and 6-month follow-ups during face-to-face assessments .
METHODS	The primary outcome measure was change in daily steps at 6 weeks , measured using an accelerometer .
METHODS	Secondary outcome measures were energy expenditure ( EE ) , duration of sedentary activity ( DSA ) , duration of moderate activity ( DMA ) , weight , diastolic/systolic blood pressure , and body fat percentage .
METHODS	Self-assessed questionnaire outcomes included fat/fiber intake , anxiety/depression , self-efficacy , and quality of life ( QOL ) .
RESULTS	A total of 94 participants were recruited and randomized to the intervention ( n = 48 ) or the usual care ( n = 46 ) group ; 84 and 73 participants completed the 6-week and 6-month follow-ups , respectively .
RESULTS	The mean number of log-ins to the program was 18.68 ( SD 13.13 , range 1-51 ) , an average of 3 log-ins per week per participant .
RESULTS	Change in daily steps walked at the 6-week follow-up was +497 ( SD 2171 ) in the intervention group and -861 ( SD 2534 ) in the control group ( 95 % CI 263-2451 , P = .02 ) .
RESULTS	Significant intervention effects were observed at the 6-week follow-up in EE ( +43.94 kcal , 95 % CI 43.93-309 .98 , P = .01 ) , DSA ( -7.79 minutes , 95 % CI -55.01 to -7.01 , P = .01 ) , DMA ( +6.31 minutes , 95 % CI 6.01-51 .20 , P = .01 ) , weight ( -0.56 kg , 95 % CI -1.78 to -0.15 , P = .02 ) , self-efficacy ( 95 % CI 0.30-4 .79 , P = .03 ) , emotional QOL score ( 95 % CI 0.01-0 .54 , P = .04 ) , and angina frequency ( 95 % CI 8.57-35 .05 , P = .002 ) .
RESULTS	Significant benefits in angina frequency ( 95 % CI 1.89-29 .41 , P = .02 ) and social QOL score ( 95 % CI 0.05-0 .54 , P = .02 ) were also observed at the 6-month follow-up .
CONCLUSIONS	An Internet-based secondary prevention intervention could be offered to those with angina .
CONCLUSIONS	A larger pragmatic trial is required to provide definitive evidence of effectiveness and cost-effectiveness .
BACKGROUND	International Standard Randomized Controlled Trial Number ( ISRCTN ) : 90110503 ; http://www.controlled-trials.com/ISRCTN90110503/ISRCTN90110503 ( Archived by WebCite at http://www.webcitation.org/6RYVOQFKM ) .

###24731892
OBJECTIVE	To compare the clinical efficacy of olive oil and the Saj ( ) cream on the occurrence and severity of striae gravidarum .
METHODS	Parallel randomized controlled clinical trial .
METHODS	West Health Centre , Lolagar and Akbarabadi Hospitals , Tehran , Iran .
METHODS	360 Nulliparous women at their second trimester of pregnancy randomly ( simple randomization ) allocated into three groups of olive oil , the Saj ( ) cream , and control that finally 150 of them ( 50 subjects in each group ) completed the study .
METHODS	Control group did not receive any medication/intervention .
METHODS	At gestational age of 38-40 weeks the participants were evaluated regarding the occurrence of striae on abdominal skin and its severity that were primary outcome of the study .
RESULTS	In the olive oil group , striae occurred in 72 % of the participants , which were mild , moderate , and severe in 32 % , 26 % , and 6 % of the cases , respectively .
RESULTS	In those who received Saj ( ) cream , striae occurred in 64 % of the cases , which were mild , moderate and severe in 16 % , 34 % , and 14 % of the cases , respectively .
RESULTS	With regard to the control group , striae occurred in 60 % of the participants , among which striae were mild , moderate , and severe in 22 % , 24 % , and 14 % of the cases , respectively .
RESULTS	There were no statistically significant differences among the three studied groups regarding the incidence or severity of striae .
CONCLUSIONS	Neither olive oil nor the Saj ( ) cream were effective in preventing the occurrence of striae gravidarum or affecting its severity .
CONCLUSIONS	Further studies to examine the effect of other herbal/chemical preparations on occurrence of striae gravidarum are recommended .

###26012640
OBJECTIVE	Elevated soluble CD40 ligand ( sCD40L ) was shown to be related to cardiovascular events , but the role of sCD40L in predicting recurrent stroke remains unclear .
METHODS	Baseline sCD40L levels were measured in 3044 consecutive patients with acute minor stroke and transient ischemic attack , who had previously been enrolled in the Clopidogrel in High-Risk Patients With Acute Nondisabling Cerebrovascular Events ( CHANCE ) trial .
METHODS	Cox proportional-hazards model was used to assess the association of sCD40L with recurrent stroke .
RESULTS	Patients in the top tertile of sCD40L levels had increased risk of recurrent stroke comparing with those in the bottom tertile , after adjusted for conventional confounding factors ( hazard ratio , 1.49 ; 95 % confidence interval , 1.11-2 .00 ; P = 0.008 ) .
RESULTS	The patients with elevated levels of both sCD40L and high-sensitive C-reactive protein also had increased risk of recurrent stroke ( hazard ratio , 1.81 ; 95 % confidence interval , 1.23-2 .68 ; P = 0.003 ) .
CONCLUSIONS	Elevated sCD40L levels independently predict recurrent stroke in patients with minor stroke and transient ischemic attack .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00979589 .

###24969516
OBJECTIVE	Microglia have been associated with inflammatory changes underlying diabetic retinopathy .
OBJECTIVE	To investigate whether low-dose oral doxycycline monohydrate , a drug capable of inhibiting microglial activation , can improve or slow the deterioration of retinal function and whether it can induce regression or slow progression of diabetic retinopathy in patients with mild to moderate nonproliferative diabetic retinopathy ( NPDR ) .
METHODS	Randomized , double-masked , 24-month proof-of-concept clinical trial .
METHODS	We randomized 33 patients ( from the Penn State Hershey Eye Center ) with at least 1 eye with mild to moderate NPDR ( Early Treatment Diabetic Retinopathy Study level 20-43 ) to doxycycline monohydrate , 50 mg/d , or daily placebo for 24 months .
METHODS	Mean change at 24 months compared with baseline in the foveal sensitivity of matrix frequency-doubling perimetry in each treatment group .
METHODS	We also compared the 2 groups with respect to change from baseline to 24 months in functional variables ( Humphrey photopic visual field testing using the Swedish interactive thresholding algorithm 24-2 strategy , contrast sensitivity , dark adaptation , visual acuity , and quality of life ) and anatomical variables ( diabetic retinopathy severity level , area of retinal thickening , central subfield thickness on optical coherence tomography , and macular volume on optical coherence tomography ) .
RESULTS	From baseline to month 24 , no significant difference was detected between groups with respect to all visual function and anatomical outcomes assessed .
CONCLUSIONS	Although a link between low-dose oral anti-inflammatory agents and subclinical improvement in inner retinal function has been suggested in patients with severe NPDR or non-high-risk proliferative diabetic retinopathy , the same association was not found in the present study of patients with mild to moderate NPDR .
CONCLUSIONS	The different findings in the 2 patient populations may relate to a differential effect of doxycycline on different stages of diabetic retinal dysfunction , or the sample size of the present study may be too small to detect a treatment effect of doxycycline in patients with mild to moderate NPDR .
BACKGROUND	clinicaltrials.gov Identifier : NCT00917553 .

###25368995
OBJECTIVE	To investigate the acute residual hormonal and neuromuscular responses exhibited following a single session of mechanical vibration applied to the upper extremities among different acceleration loads .
METHODS	Thirty male students were randomly assigned to a high vibration group ( HVG ) , a low vibration group ( LVG ) , or a control group ( CG ) .
METHODS	A randomized double-blind , controlled-parallel study design was employed .
METHODS	The measurements and interventions were performed at the Laboratory of Biomechanics of the University of L'Aquila .
METHODS	The HVG and LVG participants were exposed to a series of 20 trials 10 s of synchronous whole-body vibration ( WBV ) with a 10-s pause between each trial and a 4-min pause after the first 10 trials .
METHODS	The CG participants assumed an isometric push-up position without WBV .
METHODS	The outcome measures were growth hormone ( GH ) , testosterone , maximal voluntary isometric contraction during bench-press , maximal voluntary isometric contraction during handgrip , and electromyography root-mean-square ( EMGrms ) muscle activity ( pectoralis major [ PM ] , triceps brachii [ TB ] , anterior deltoid [ DE ] , and flexor carpi radialis [ FCR ] ) .
RESULTS	The GH increased significantly over time only in the HVG ( P = 0.003 ) .
RESULTS	Additionally , the testosterone levels changed significantly over time in the LVG ( P = 0.011 ) and the HVG ( P = 0.001 ) .
RESULTS	MVC during bench press decreased significantly in the LVG ( P = 0.001 ) and the HVG ( P = 0.002 ) .
RESULTS	In the HVG , the EMGrms decreased significantly in the TB ( P = 0.006 ) muscle .
RESULTS	In the LVG , the EMGrms decreased significantly in the DE ( P = 0.009 ) and FCR ( P = 0.006 ) muscles .
CONCLUSIONS	Synchronous WBV acutely increased GH and testosterone serum concentrations and decreased the MVC and their respective maximal EMGrms activities , which indicated a possible central fatigue effect .
CONCLUSIONS	Interestingly , only the GH response was dependent on the acceleration with respect to the subjects ' responsiveness .

###24611442
OBJECTIVE	The purpose of this study was to assess long-term safety and tolerability of desvenlafaxine ( administered as desvenlafaxine succinate ) in children and adolescents with major depressive disorder ( MDD ) .
METHODS	An 8 week , multicenter , open-label , fixed-dose study of children ( ages 7-11 years ) and adolescents ( ages 12-17 years ) with MDD was followed by a 6 month , flexible-dose extension study .
METHODS	Patients were administered desvenlafaxine 10-100mg / day ( children ) or 25-200mg / day ( adolescents ) for a total of 8 months .
METHODS	Treatment-emergent adverse events ( AEs ) , withdrawals because of AEs , laboratory tests , vital signs , and the Columbia Suicide-Severity Rating Scale ( C-SSRS ) were collected .
METHODS	Eight month safety results from the lead-in plus extension studies are reported for extension study participants , using lead-in study day -1 as baseline .
RESULTS	Forty patients were enrolled in both studies ( 20 children ; 20 adolescents ) .
RESULTS	Of those , four children and three adolescents withdrew because of AEs .
RESULTS	Treatment-emergent AEs reported by three or more patients were upper abdominal pain ( 15 % ) and headache ( 15 % ) in children , and somnolence ( 30 % ) , nausea ( 20 % ) , upper abdominal pain ( 15 % ) , and headache ( 15 % ) in adolescents .
RESULTS	Negativism ( oppositional behavior ) in a child was the single serious AE reported .
RESULTS	No deaths occurred during the lead-in or extension studies .
RESULTS	Mean pulse rates demonstrated statistically significant increases from lead-in study baseline to final evaluation ( children , +5.2 bpm ; adolescents , +5.9 bpm ; p0 .05 ) .
RESULTS	No statistically significant change in blood pressure was observed at final evaluation .
RESULTS	Two adolescents ( 0 children ) reported suicidal ideation on the C-SSRS at screening assessment and during the lead-in and/or extension trials ; one adolescent reported suicidal ideation after screening only .
CONCLUSIONS	Long-term ( 8 month ) treatment with desvenlafaxine was generally safe and well tolerated in depressed children and adolescents .

###24682356
OBJECTIVE	To evaluate the effect of a programme of active self-correction and task-oriented exercises on spinal deformities and health-related quality of life ( HRQL ) in patients with mild adolescent idiopathic scoliosis ( AIS ) ( Cobb angle < 25 ) .
METHODS	This was a parallel-group , randomised , superiority-controlled study in which 110 patients were randomly assigned to a rehabilitation programme consisting of active self-correction , task-oriented spinal exercises and education ( experimental group , 55 subjects ) or traditional spinal exercises ( control group , 55 subjects ) .
METHODS	Before treatment , at the end of treatment ( analysis at skeletal maturity ) , and 12 months later ( follow-up ) , all of the patients underwent radiological deformity ( Cobb angle ) , surface deformity ( angle of trunk rotation ) and HRQL evaluations ( SRS-22 questionnaire ) .
METHODS	A linear mixed model for repeated measures was used for each outcome measure .
RESULTS	There were main effects of time ( p < 0.001 ) , group ( p < 0.001 ) and time by group interaction ( p < 0.001 ) on radiological deformity : training in the experimental group led to a significant improvement ( decrease in Cobb angle of > 5 ) , whereas the control group remained stable .
RESULTS	Analysis of all of the secondary outcome measures revealed significant effects of time , group and time by group interaction in favour of the experimental group .
CONCLUSIONS	The programme of active self-correction and task-oriented exercises was superior to traditional exercises in reducing spinal deformities and enhancing the HRQL in patients with mild AIS .
CONCLUSIONS	The effects lasted for at least 1 year after the intervention ended .

###25851423
OBJECTIVE	To evaluate the effect of intraoperative acupuncture on posttonsillectomy pain in the pediatric population .
METHODS	Prospective , double-blind , randomized , placebo-controlled trial .
METHODS	Patients aged 3 to 12 years undergoing tonsillectomy were recruited at a tertiary children 's hospital between February 2011 and May 2012 .
METHODS	Participants were block-randomized to receive acupuncture or sham acupuncture during anesthesia for tonsillectomy .
METHODS	Surgeons , staff , and parents were blinded from treatment .
METHODS	Tonsillectomy was performed by one of two surgeons using a standard technique ( monopolar cautery ) , and a single anesthetic protocol was followed .
METHODS	Study endpoints included time spent in the postanesthesia care unit , the amount of opioids administered in the perioperative period , and pain measures and presence of nausea/vomiting from postoperative home surveys .
RESULTS	Fifty-nine children aged 3 to 12 years were randomized to receive acupuncture ( n = 30 ) or sham acupuncture ( n = 29 ) .
RESULTS	No significant demographic differences were noted between the two cohorts .
RESULTS	Perioperative data were recorded for all patients ; 73 % of patients later returned home surveys .
RESULTS	There were no significant differences in the amount of opioid medications administered or total postanesthesia care unit time between the two cohorts .
RESULTS	Home surveys of patients but not of parents revealed significant improvements in pain control in the acupuncture treatment-group postoperatively ( P = 0.0065 and 0.051 , respectively ) , and oral intake improved significantly earlier in the acupuncture treatment group ( P = 0.01 ) .
RESULTS	No adverse effects of acupuncture were reported .
CONCLUSIONS	This study demonstrates that intraoperative acupuncture is feasible , well tolerated , and results in improved pain and earlier return of diet postoperatively .
METHODS	1b .

###24321380
BACKGROUND	Results supporting the use and the effectiveness of positive expiratory , pressure devices in chronic obstructive pulmonary disease ( COPD ) patients are still controversial , We have tested the hypothesis that adding TPEP or IPPB to standard pharmacological therapy may provide additional clinical benefit over , pharmacological therapy only in patients with severe COPD .
METHODS	Fourty-five patients were randomized in three groups : a group was treated ; with IPPB , a group was treated with TPEP and a group with pharmacological ; therapy alone ( control group ) .
METHODS	Primary outcome measures included the measurement of scale or , questionnaire concerning dyspnea ( MRC scale ) , dyspnea , cough , and , sputum ( BCSS ) and quality of life ( COPD assessment test ) ( CAT ) .
METHODS	Secondary , outcome measures were respiratory function testing , arterial blood gas , analysis , and hematological examinations .
RESULTS	Both patients in the IPPB group and in the TPEP group showed a significant , improvement in two of three tests ( MRC , CAT ) compared to the control , group.However , in the group comparison analysis for , the same variables between IPPB group and TPEP group we observed a , significant improvement in the IPPB group ( P. 05 for MRC and P. 01 for , CAT ) .
RESULTS	The difference of action of the two techniques are evident in the results of , pulmonary function testing : IPPB increases FVC , FEV1 , and MIP ; this reflects , its capacity to increase lung volume .
RESULTS	Also TPEP increases FVC and FEV1 ( less , than IPPB ) , but increases MEP , while decreasing total lung capacity and , residual volume .
CONCLUSIONS	The two techniques ( IPPB and TPEP ) improves significantly dyspnea ; quality of ; life tools and lung function in patients with severe COPD .
CONCLUSIONS	IPPB demonstrated a greater effectiveness to improve dyspnea and quality of life tools ( MRC , CAT ) than TPEP .

###26192873
BACKGROUND	Data from randomized trials are lacking on the benefits and risks of initiating antiretroviral therapy in patients with asymptomatic human immunodeficiency virus ( HIV ) infection who have a CD4 + count of more than 350 cells per cubic millimeter .
METHODS	We randomly assigned HIV-positive adults who had a CD4 + count of more than 500 cells per cubic millimeter to start antiretroviral therapy immediately ( immediate-initiation group ) or to defer it until the CD4 + count decreased to 350 cells per cubic millimeter or until the development of the acquired immunodeficiency syndrome ( AIDS ) or another condition that dictated the use of antiretroviral therapy ( deferred-initiation group ) .
METHODS	The primary composite end point was any serious AIDS-related event , serious non-AIDS-related event , or death from any cause .
RESULTS	A total of 4685 patients were followed for a mean of 3.0 years .
RESULTS	At study entry , the median HIV viral load was 12,759 copies per milliliter , and the median CD4 + count was 651 cells per cubic millimeter .
RESULTS	On May 15 , 2015 , on the basis of an interim analysis , the data and safety monitoring board determined that the study question had been answered and recommended that patients in the deferred-initiation group be offered antiretroviral therapy .
RESULTS	The primary end point occurred in 42 patients in the immediate-initiation group ( 1.8 % ; 0.60 events per 100 person-years ) , as compared with 96 patients in the deferred-initiation group ( 4.1 % ; 1.38 events per 100 person-years ) , for a hazard ratio of 0.43 ( 95 % confidence interval [ CI ] , 0.30 to 0.62 ; P < 0.001 ) .
RESULTS	Hazard ratios for serious AIDS-related and serious non-AIDS-related events were 0.28 ( 95 % CI , 0.15 to 0.50 ; P < 0.001 ) and 0.61 ( 95 % CI , 0.38 to 0.97 ; P = 0.04 ) , respectively .
RESULTS	More than two thirds of the primary end points ( 68 % ) occurred in patients with a CD4 + count of more than 500 cells per cubic millimeter .
RESULTS	The risks of a grade 4 event were similar in the two groups , as were the risks of unscheduled hospital admissions .
CONCLUSIONS	The initiation of antiretroviral therapy in HIV-positive adults with a CD4 + count of more than 500 cells per cubic millimeter provided net benefits over starting such therapy in patients after the CD4 + count had declined to 350 cells per cubic millimeter .
CONCLUSIONS	( Funded by the National Institute of Allergy and Infectious Diseases and others ; START ClinicalTrials.gov number , NCT00867048 . )

###25233867
BACKGROUND	Weight gain during the childbearing years and failure to lose pregnancy weight after birth contribute to the development of obesity in postpartum Latinas .
METHODS	Madres para la Salud [ Mothers for Health ] was a 12-month , randomized controlled trial exploring a social support intervention with moderate-intensity physical activity ( PA ) seeking to effect changes in body fat , fat tissue inflammation , and depression symptoms in sedentary postpartum Latinas .
METHODS	This report describes the efficacy of the Madres intervention .
RESULTS	The results show that while social support increased during the active intervention delivery , it declined to pre-intervention levels by the end of the intervention .
RESULTS	There were significant achievements in aerobic and total steps across the 12months of the intervention , and declines in body adiposity assessed with bioelectric impedance .
CONCLUSIONS	Social support from family and friends mediated increases in aerobic PA resulting in decrease in percent body fat .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01908959 .

###24408084
OBJECTIVE	We sought to investigate the relationship between the SYNTAX score ( SS ) and stent thrombosis ( ST ) in patients with non-ST-segment elevation acute coronary syndromes ( NSTE-ACS ) undergoing percutaneous coronary intervention ( PCI ) .
BACKGROUND	The relationship between the SS and ST is undetermined .
METHODS	We stratified 2,627 patients undergoing PCI in the ACUITY trial by SS tertile according to the current population ( true tertiles , SS < 7 , SS = 7-12 , and SS > 12 ) and by the SYNTAX trial ( original SYNTAX tertiles , SS < 23 , SS = 23-32 , and SS > 32 ) .
METHODS	Thirty-day and 1-year rates of definite/probable ST were determined for each tertile .
RESULTS	A total 30 ( 1.1 % ) and 41 ( 1.6 % ) definite/probable ST events occurred by 30 days and 1 year , respectively .
RESULTS	When stratified by true tertiles , 30-day and 1-year rates of definite/probable ST were significantly greater in the highest tertile ( SS > 12 ; 2.0 % and 2.8 % ) compared with the intermediate ( SS = 7-12 ; 0.7 % and 1.1 % ) and lowest tertiles ( SS < 7 ; 0.6 % and 0.7 % ) , P = 0.007 and P = 0.0009 , respectively .
RESULTS	When stratified by original SYNTAX tertiles , 30-day and 1-year rates of definite/probable ST were significantly greater in the highest ( SS > 32 ; 6.3 % and 8.8 % ) and intermediate tertiles ( SS = 23-32 ; 2.8 % and 3.7 % ) compared with the lowest tertile ( SS < 22 ; 0.8 % and 1.2 % ) , P < 0.0001 for both .
RESULTS	By multivariable analysis , the SS was an independent predictor for both 30-day and 1-year definite/probable ST.
CONCLUSIONS	In patients with NSTE-ACS undergoing PCI , the extent and severity of CAD , as assessed by the SS before revascularization , was strongly associated with the occurrence of ST both at 30 days and 1 year .
CONCLUSIONS	2014 Wiley Periodicals , Inc. .

###24291283
OBJECTIVE	This study sought to identify the incidence , predictors , and prognostic impact of bleeding complications ( BC ) after surgical aortic valve replacement ( SAVR ) compared with transcatheter aortic valve replacement ( TAVR ) .
BACKGROUND	Bleeding complications after SAVR and TAVR are frequent and may be associated with an unfavorable prognosis .
METHODS	In the randomized controlled PARTNER ( Placement of Aortic Transcatheter Valve ) I trial , 657 patients from cohort A ( operable high risk ) were randomly assigned to SAVR or TAVR ( transfemoral [ TF ] if iliofemoral access was suitable or transapical [ TA ] if not ) and received the designated treatment .
METHODS	First-generation Edwards SAPIEN valves and delivery systems ( Edwards Lifesciences , Irvine , California ) were used for TAVR , through a 22 - or 24-F sheath .
METHODS	The 30-day rates of major BC ( modified Valve Academic Research Consortium definitions ) , predictors of BC , and their association with 1-year mortality were assessed .
RESULTS	A total of 71 ( 22.7 % ) , 27 ( 11.3 % ) , and 9 ( 8.8 % ) patients had major BC within 30 days of the procedure after SAVR , TF-TAVR , and TA-TAVR , respectively ( p < 0.0001 ) .
RESULTS	SAVR was associated with a significantly higher 30-day rate of transfusion ( 17.9 % ) than either TF-TAVR ( 7.1 % ) or TA-TAVR ( 4.8 % ; p < 0.0001 ) .
RESULTS	Independent predictors of major BC were the occurrence of major vascular complications and use of intraprocedural hemodynamic support among TF-TAVR patients , severe procedural complications requiring conversion to open surgery among TA-TAVR patients , and the presence of low hemoglobin at baseline among SAVR patients .
RESULTS	Major BC was identified as the strongest independent predictor of 1-year mortality among the full cohort .
RESULTS	However , risk-adjusted analyses demonstrated a significant interaction between BC and treatment strategy with respect to mortality , suggesting that BC after SAVR have a greater impact on prognosis than after TAVR .
CONCLUSIONS	Among high-risk aortic stenosis patients enrolled in the PARTNER I randomized trial , BC were more common after SAVR than after TAVR and were also associated with a worse long-term prognosis .
CONCLUSIONS	( THE PARTNER TRIAL : Placement of AoRTic TraNscathetER Valve Trial ; NCT00530894 ) .

###24756361
OBJECTIVE	Abuse of opioid analgesics has become a public health issue .
OBJECTIVE	Some opioid abusers use intravenous administration to increase the magnitude of positive reinforcing effects .
OBJECTIVE	Intravenous co-administration of oxycodone with naloxone , an opioid antagonist , may reduce these rewarding effects and discourage abuse .
OBJECTIVE	A 2:1 oxycodone : naloxone ( OXN ) tablet formulation has been studied in the USA for the management of moderate-to-severe chronic pain .
OBJECTIVE	Intravenous administration of a 2:1 oxycodone : naloxone solution ( sOXN ) reflects the oxycodone : naloxone ratio found in laboratory studies of OXN following tampering for intravenous administration .
OBJECTIVE	The objective of this study was to characterize abuse-deterrent properties of sOXN .
METHODS	This single-center , double-blind , randomized , placebo-controlled , active-controlled , crossover study enrolled nondependent recreational opioid users with experience using multiple ( two or more ) routes of administration .
METHODS	Following demonstration that subjects could discern between placebo and oxycodone , 24 eligible male and female subjects were randomized to receive intravenous injections of 0.07 mg/kg oxycodone ( OXY ) , 0.07 mg/kg oxycodone and 0.035 mg/kg naloxone solution ( sOXN ) , or matching placebo over three visits .
METHODS	Pharmacokinetics , pharmacodynamics , safety , and tolerability were assessed at scheduled times up to 8h post-dose .
METHODS	Parameters were computed and statistically compared among treatments .
RESULTS	Pharmacokinetics were similar between OXY and sOXN .
RESULTS	Subjects reported significantly fewer rewarding effects with sOXN compared with OXY ; differences between sOXN and placebo were generally not significant .
RESULTS	sOXN was well tolerated .
CONCLUSIONS	Significant reductions in drug liking and other subjective effects following administration of sOXN compared with OXY indicate that naloxone concentrations were sufficient to antagonize the effects of oxycodone when abused by the intravenous route of administration in opioid-experienced drug users .

###24795163
BACKGROUND	Impaired trunk motor control is common after stroke .
BACKGROUND	Combining transcutaneous electrical nerve stimulation ( TENS ) with task-related trunk training ( TRTT ) has been shown to enhance the recovery of lower limb motor function .
OBJECTIVE	This study investigated whether combining TENS with TRTT would enhance trunk control after stroke .
OBJECTIVE	Methods .
OBJECTIVE	Thirty-seven subjects with stroke were recruited into a randomized controlled clinical trial .
OBJECTIVE	Subjects were randomly assigned to any one of the three 6-week home-based training groups : ( 1 ) TENS + TRTT , ( 2 ) placebo TENS + TRTT , or ( 3 ) control without active training .
OBJECTIVE	The outcome measures included isometric peak trunk flexion torque and extension torque ; forward seated and lateral seated reaching distance to the affected and unaffected side ; and Trunk Impairment Scale ( TIS ) scores .
OBJECTIVE	All outcome measures were assessed at baseline , after 3 and 6 weeks of training , and 4 weeks after training ended at follow-up .
RESULTS	Both the TENS + TRTT and the placebo-TENS + TRTT groups had significantly greater improvements in isometric peak trunk flexion torque and extension torque , lateral seated reaching distance to affected and unaffected side , and TIS score than the control group after 3 weeks of training .
RESULTS	The TENS + TRTT group had significantly greater and earlier improvement in its mean TIS score than the other 2 groups .
CONCLUSIONS	Home-based TRTT is effective for improving trunk muscle strength , sitting functional reach and trunk motor control after stroke in subjects without somatosensory deficits .
CONCLUSIONS	The addition of TENS to the trunk augments the effectiveness of the exercise in terms of TIS scores within the first 3 weeks of training .

###25146062
OBJECTIVE	This study was performed to investigate the effect of Seidlitzia rosmarinus on the clinical symptoms of benign prostatic hyperplasia .
METHODS	This single-blind clinical trial included 98 patients with voiding and storage symptoms in Shohada Ashayer Hospital of Khorramabad .
METHODS	The patients were randomly divided into two groups of treatment with prazosin 1mg/day plus Seidlitzia rosmarinus 3g/day and treatment with prazosin 1mg/day .
METHODS	The clinical symptoms were measured using the International Prostate Symptoms Score ( IPSS ) questionnaire .
METHODS	Serum prostate-specific antigen ( PSA ) level , prostate volume , and residual urine volume before and 2 months after the intervention were measured .
RESULTS	The results of the study before the intervention did not show significant differences between the prazosin and Seidlitzia rosmarinus plus prazosin groups for the scores of clinical symptoms , PSA level , prostate volume , and residual urine volume ( p > 0.05 ) .
RESULTS	However , significant differences were found between the two groups after the intervention for the mean change scores of clinical symptoms ( 6.8 scores in the Seidlitzia rosmarinus group vs. 2 scores in the control group ) ( p < 0.001 ) , while no significant differences were found for the mean change scores of PSA level , prostate volume , and residual urine volume ( p > 0.05 ) .
CONCLUSIONS	The results of the study showed that the simultaneous consumption of Seidlitzia rosmarinus and prazosin , compared to the consumption of prazosin alone , results in significant improvements in the clinical symptoms of benign prostatic hyperplasia .

###25858265
OBJECTIVE	To evaluate whether a disease activity guided strategy of dose reduction of two tumour necrosis factor ( TNF ) inhibitors , adalimumab or etanercept , is non-inferior in maintaining disease control in patients with rheumatoid arthritis compared with usual care .
METHODS	Randomised controlled , open label , non-inferiority strategy trial .
METHODS	Two rheumatology outpatient clinics in the Netherlands , from December 2011 to May 2014 .
METHODS	180 patients with rheumatoid arthritis and low disease activity using adalimumab or etanercept ; 121 allocated to the dose reduction strategy , 59 to usual care .
METHODS	Disease activity guided dose reduction ( advice to stepwise increase the injection interval every three months , until flare of disease activity or discontinuation ) or usual care ( no dose reduction advice ) .
METHODS	Flare was defined as increase in DAS28-CRP ( a composite score measuring disease activity ) greater than 1.2 , or increase greater than 0.6 and current score of at least 3.2 .
METHODS	In the case of flare , TNF inhibitor use was restarted or escalated .
METHODS	Difference in proportions of patients with major flare ( DAS28-CRP based flare longer than three months ) between the two groups at 18 months , compared against a non-inferiority margin of 20 % .
METHODS	Secondary outcomes included TNF inhibitor use at study end , functioning , quality of life , radiographic progression , and adverse events .
RESULTS	Dose reduction of adalimumab or etanercept was non-inferior to usual care ( proportion of patients with major flare at 18 months , 12 % v 10 % ; difference 2 % , 95 % confidence interval -12 % to 12 % ) .
RESULTS	In the dose reduction group , TNF inhibitor use could successfully be stopped in 20 % ( 95 % confidence interval 13 % to 28 % ) , the injection interval successfully increased in 43 % ( 34 % to 53 % ) , but no dose reduction was possible in 37 % ( 28 % to 46 % ) .
RESULTS	Functional status , quality of life , relevant radiographic progression , and adverse events did not differ between the groups , although short lived flares ( 73 % v 27 % ) and minimal radiographic progression ( 32 % v 15 % ) were more frequent in dose reduction than usual care .
CONCLUSIONS	A disease activity guided , dose reduction strategy of adalimumab or etanercept to treat rheumatoid arthritis is non-inferior to usual care with regard to major flaring , while resulting in the successful dose reduction or stopping in two thirds of patients.Trial registration Dutch trial register ( www.trialregister.nl ) , NTR 3216 .

###25042877
OBJECTIVE	Peeping testis is an inconsistently palpable/seen undescended testis that migrates back and forth at the internal inguinal ring .
OBJECTIVE	Both open and laparoscopic orchiopexy are effective forms of management .
OBJECTIVE	The present study aimed to evaluate the efficacy and safety of both approaches .
METHODS	Between September 2007 and January 2012 , 46 peeping inguinal testes were randomly treated with either open ( 25 cases ) or laparoscopic ( 21 cases ) orchiopexy procedures .
METHODS	Spermatic vessels were preserved for all cases .
METHODS	Operative details , postoperative morbidity and final testicular site and size were recorded .
RESULTS	The median age of the children was 2.5 years ( range 0.5-12 .0 ) .
RESULTS	The follow-up period ranged from 1.0 to 5.5 years .
RESULTS	Of these testes , 20 in the open surgery group and 19 in the laparoscopic group maintained correct intrascrotal position ( P = 0.428 ) .
RESULTS	Re-do orchiopexy was indicated for two cases in the surgical group ( P = 0.493 ) .
RESULTS	No cases of testicular atrophy or hernia were encountered .
CONCLUSIONS	Open and laparoscopic orchiopexy procedures for peeping testes are fairly comparable .
CONCLUSIONS	However , laparoscopy is relatively more effective , as two re-do orchiopexies were required in the open surgical group .

###24380501
BACKGROUND	The recommended screening interval when using the Papanicolaou ( Pap ) and human papillomavirus ( HPV ) test ( co-testing ) is 5 years .
BACKGROUND	However because providers are reluctant to extend the screening interval , we launched a study to identify barriers to appropriate use of the co-test and to implement an educational intervention to promote evidence-based screening practices .
BACKGROUND	This article provides an overview of the study including the multi-component intervention and participant demographics .
METHODS	The study was conducted in 15 clinics associated with 6 Federally Qualified Health Centers ( FQHCs ) in Illinois .
METHODS	Each clinic received HPV tests to administer with routine Pap tests among enrolled patients ( n = 2,246 ) and was assigned to a study arm : intervention arm ( n = 7 ) received a multi-component educational intervention ( small media , academic detailing , and website ) for providers and printed educational materials for patients , and control arm ( n = 8 ) received printed copies of general guidelines .
METHODS	Clinic coordinators ( n = 15 ) , providers ( n = 98 ) , and patients ( n = 984 ) completed baseline surveys to assess screening practices .
RESULTS	Providers reported an average age of 41.3 years and were predominately female , non-Hispanic , and white .
RESULTS	Patients reported an average age of 45.0 years and nearly two-thirds were Hispanic or black .
RESULTS	Of the 2,246 patients , 89 % had a normal co-test .
RESULTS	Lessons learned from the study included the importance of buy-in at a high level in the organization , a champion provider , and a clinical coordinator devoted to the study .
CONCLUSIONS	Materials from this study can be adapted to educate providers and patients on appropriate use of the co-test and encourage extended screening intervals as a safe and effective practice .

###24668358
OBJECTIVE	To compare the effectiveness of a core stability program with a task-oriented motor training program in improving motor proficiency in children with developmental coordination disorder ( DCD ) .
METHODS	Randomized controlled pilot trial .
METHODS	Outpatient unit in a hospital .
METHODS	Twenty-two children diagnosed with DCD aged 6-9 years were randomly allocated to the core stability program or the task-oriented motor program .
METHODS	Both groups underwent their respective face-to-face training session once per week for eight consecutive weeks .
METHODS	They were also instructed to carry out home exercises on a daily basis during the intervention period .
METHODS	Short Form of the Bruininks-Oseretsky Test of Motor Proficiency ( Second Edition ) and Sensory Organization Test at pre - and post-intervention .
RESULTS	Intention-to-treat analysis revealed no significant between-group difference in the change of motor proficiency standard score ( P = 0.717 ) , and composite equilibrium score derived from the Sensory Organization Test ( P = 0.100 ) .
RESULTS	Further analysis showed significant improvement in motor proficiency in both the core stability ( mean change ( SD ) = 6.3 ( 5.4 ) ; p = 0.008 ) and task-oriented training groups ( mean change ( SD ) = 5.1 ( 4.0 ) ; P = 0.007 ) .
RESULTS	The composite equilibrium score was significantly increased in the task-oriented training group ( mean change ( SD ) = 6.0 ( 5.5 ) ; P = 0.009 ) , but not in the core stability group ( mean change ( SD ) = 0.0 ( 9.6 ) ; P = 0.812 ) .
RESULTS	In the task-oriented training group , compliance with the home program was positively correlated with change in motor proficiency ( = 0.680 , P = 0.030 ) and composite equilibrium score ( = 0.638 , P = 0.047 ) .
CONCLUSIONS	The core stability exercise program is as effective as task-oriented training in improving motor proficiency among children with DCD .

###25112783
BACKGROUND	Plantago ovata husk therapy could be used in patients with Parkinson disease to reduce the symptoms of gastrointestinal disorders , but it is important to know whether this compound modifies levodopa pharmacokinetics .
BACKGROUND	The maintenance of constant plasma concentrations of levodopa abolishes the clinical fluctuations in parkinsonian patients .
BACKGROUND	The aim of this randomised clinical trial was to establish the influence of the fiber Plantago ovata husk in the pharmacokinetics of levodopa when administered to Parkinson patients well controlled by their oral medication .
METHODS	To evaluate the effects of this fiber on several biochemical parameters .
METHODS	18 volunteers participated in the study and received alternatively two treatments ( Plantago ovata husk or placebo ) with their usual levodopa/carbidopa oral dose .
METHODS	On days 0 ( initial situation ) , 14 and 35 of the study , blood samples were taken to assess levodopa pharmacokinetics and to determine biochemical parameters .
RESULTS	Levodopa Cmax was very similar in the initial situation ( 603.2 ng/ml ) and after placebo administration ( 612.0 ng/ml ) , being slightly lower ( 547.8 ng/ml ) when Plantago ovata husk was given .
RESULTS	AUC was very similar in the three groups : initial situation .
RESULTS	- 62.87 g.min / ml , fiber treatment .
RESULTS	- 64.47 g.min / ml and placebo treatment .
RESULTS	- 65.10 g.min / ml .
RESULTS	Fiber reduced significantly the number of peaks observed in the levodopa concentrations , maintaining concentrations more stable .
RESULTS	No significant differences were found in total cholesterol , LDL-cholesterol and triglycerides with the administration of Plantago ovata husk .
CONCLUSIONS	Plantago ovata husk administration caused a smoothing and homogenization of levodopa absorption , providing more stable concentrations and final higher levels , resulting in a great benefit for patients .
BACKGROUND	EudraCT2006-000491-33 .

###24938449
OBJECTIVE	To investigate the effect of Longbishu Capsule ( , LBS ) , doxazosin , and combination therapy on benign prostatic hyperplasia ( BPH ) .
METHODS	A randomized , double-blind , multi-center parallel trial was conducted involving 360 patients in hospitals in Beijing ( 108 cases ) , Heilongjiang ( 90 cases ) , Sichuan ( 90 cases ) , Shanghai ( 72 cases ) , China .
METHODS	They were randomly assigned with central randomization method to group A ( LBS placebo plus doxazosin ) , group B ( LBS plus doxazosin ) or group C ( LBS plus doxazosin placebo ) , 120 cases for each group .
METHODS	The international prostate symptom score , maximum urinary flow rate , postvoid residual urine volume and prostate volume were measured for evaluating the efficacy of the three treatments .
RESULTS	At baseline , there was no significant difference in the measured variables among the three groups .
RESULTS	After 12-month treatment , the three groups showed significant improvements in IPSS and maximum urinary flow rate from baseline ( P < 0.01 ) .
RESULTS	Although postvoid residual urine volume was not significantly different from the baseline in group A ( P > 0.05 ) , it significantly decreased in group B and C ( P < 0.05 ) .
RESULTS	The incidence of adverse events were similar among the three groups .
CONCLUSIONS	The treatment of LBS alone or LBS plus doxazosin was able to significantly improve IPSS in patients with BPH .
CONCLUSIONS	The treatments may reduce the increase in prostate volume and postvoid residual urine volume as well .

###25041101
BACKGROUND	Inhalational induction in children is easiest to perform with the Ayres t-piece & bag ( Mapleson F ) .
BACKGROUND	Drawover anesthesia systems may be used but have not been studied .
BACKGROUND	The aim of this study was to examine the quality of induction of anesthesia in children comparing a continuous flow system using the Farman entrainer and the pediatric t-piece , to a pediatric drawover system .
METHODS	We conducted a randomized controlled trial in accordance with departmental and institutional standards with 60 subjects who received inhalational induction using either apparatus .
RESULTS	There was no evidence of a difference in the median Sp02 between the two methods ( P = 0.626 ) neither was there a difference between the method of induction regarding abdominal distension ( P = 0.348 ) or restraint ( P = 0.186 ) .
RESULTS	Induction time using the pediatric drawover apparatus 240 ( range 115-605 ) seconds was significantly greater than the Farman entrainer/t-piece 146 ( range 65-535 ) seconds ( P < 0.05 ) .
CONCLUSIONS	We consider that this difference is unlikely to be clinically significant in many cases ; however , the increased speed using the entrainer and t-piece may sometimes confer an advantage .

###24326918
BACKGROUND	The reliability and validity of various Objective Structured Clinical Examinations ( OSCEs ) have been well documented in the medical and nursing literature .
BACKGROUND	The purpose of this study was to examine the effect of exam preparation methods on student performance and student satisfaction for an OSCE used to assess doctoral physical therapist students .
METHODS	Sixty-five physical therapist students from two post-professional physical therapist programs were randomized to a rubric exam preparation group and a nonrubric exam preparation group for a musculoskeletal OSCE .
METHODS	The OSCE was a midterm practical exam for a peripheral joint musculoskeletal course .
METHODS	Upon completion of the exam , all students completed a post-exam satisfaction survey .
RESULTS	The results of the 2 x 2 ANCOVA that examined performance and satisfaction on the OSCE indicated a significant interaction between the group assignment and program , p < 0.028 , for performance , and that satisfaction scores between the rubric and nonrubric groups and program were not significant for any of the questions asked on the post-examination survey .
CONCLUSIONS	Despite the reported benefit of utilizing rubrics , the findings of this study did not show a difference in student performance or satisfaction when using a rubric to prepare for an OSCE .

###25587091
BACKGROUND	Single-site studies have demonstrated inadequate quality of discharge summaries in timeliness , transmission , and content , potentially contributing to adverse outcomes .
BACKGROUND	However , degree of hospital-level variation in discharge summary quality for patients hospitalized with heart failure ( HF ) is uncertain .
RESULTS	We analyzed discharge summaries of patients enrolled in the Telemonitoring to Improve Heart Failure Outcomes ( Tele-HF ) study .
RESULTS	We assessed hospital-level performance on timeliness ( fraction of summaries completed on the day of discharge ) , documented transmission to the follow-up physician , and content ( presence of components suggested by the Transitions of Care Consensus Conference ) .
RESULTS	We obtained 1501 discharge summaries from 1640 ( 91.5 % ) patients discharged alive from 46 hospitals .
RESULTS	Among hospitals contributing 10 summaries , the median hospital dictated 69.2 % of discharge summaries on the day of discharge ( range , 0.0 % -98.0 % ; P < 0.001 ) ; documented transmission of 33.3 % of summaries to the follow-up physician ( range , 0.0 % -75.7 % ; P < 0.001 ) ; and included 3.6 of 7 Transitions of Care Consensus Conference elements ( range , 2.9-4 .5 ; P < 0.001 ) .
RESULTS	Hospital course was typically included ( 97.2 % ) , but summaries were less likely to include discharge condition ( 30.7 % ) , discharge volume status ( 16.0 % ) , or discharge weight ( 15.7 % ) .
RESULTS	No discharge summary included all 7 Transitions of Care Consensus Conference-endorsed content elements , was dictated on the day of discharge , and was sent to a follow-up physician .
CONCLUSIONS	Even at the highest performing hospital , discharge summary quality is insufficient in terms of timeliness , transmission , and content .
CONCLUSIONS	Improvements in all aspects of discharge summary quality are necessary to enable the discharge summary to serve as an effective transitional care tool .

###24685786
OBJECTIVE	To evaluate and compare the effcacy of preprocedural mouthrinses ( chlorhexidine digluconate and tea tree oil ) in reducing microbial content of aerosol product during ultrasonic scaling procedures by viable bacterial count .
METHODS	It was a randomized single blind , placebo-controlled parallel group study .
METHODS	Sixty subjects were randomly assigned to rinse 10 ml of any one of the mouthrinses ( chlorhexidine digluconate or tea tree oil or distilled water ) .
METHODS	Ultrasonic scaling was done for a period of 10 minutes in presence of trypticase soy agar plates placed at standardized distance .
METHODS	Plates were then sent for microbiological evaluation for the aerosol produced .
RESULTS	This study showed that all the antiseptic mouthwashes signifcantly reduced the bacterial colony forming units ( CFUs ) in aerosol samples .
RESULTS	Chlorhexidine rinses were found to be superior to tea tree when used preprocedurally in reducing aerolized bacteria .
CONCLUSIONS	This study advocates preprocedural dural rinsing with an effective antimicrobial mouthrinse during any dental treatment which generates aerosols , reduces the risk of cross-contamination with infectious agents in the dental operatory .
CONCLUSIONS	The aerolization of oral microbes occurring during dental procedures can potentially result in cross-contamination in the dental operatory and transmission of infectious agents to both dental professionals and patient .
CONCLUSIONS	It is reasonable to assume therefore , that any stratagem for reducing the viable bacterial content of these aerosols could lower the risk of cross-contamination .

###24369912
OBJECTIVE	We investigated the effects of weight loss and maintenance with diets that varied with regard to protein content and glycemic index ( GI ) on metabolic syndrome ( MetSyn ) status .
METHODS	Secondary analyses were performed within the Diet , Obesity and Genes ( DiOGenes ) study ( 2006-2008 ) , a randomized controlled dietary intervention .
METHODS	Nine hundred and thirty-eight overweight and obese adults from eight European countries entered an 8-wk low-calorie-diet period .
METHODS	Seven hundred and seventy-three adults who lost at least 8 % of their body weights were randomized to one of five ad libitum diets for 6 mo : 1 ) low-protein ( LP ) / low-GI ( LGI ) ; 2 ) LP/high-GI ( HGI ) ; 3 ) high-protein ( HP ) / LGI ; 4 ) HP/HGI ; and 5 ) control diet .
METHODS	MetSyn prevalence and a standardized MetSyn score were assessed at baseline , after the low-calorie diet , and after the intervention .
RESULTS	Weight loss among participants while on the low-calorie diet significantly reduced MetSyn prevalence ( 33.9 % versus 15.9 % ; P < 0.001 ) and MetSyn score ( -1.48 versus -4.45 ; P < 0.001 ) .
RESULTS	During weight maintenance , significant changes in MetSyn score were observed between the groups , with the highest increase detected in the LP/HGI group ( P = 0.039 , partial ( 2 ) = 0.023 ) .
RESULTS	Protein , GI , and their interaction did not have isolated effects on study outcomes .
CONCLUSIONS	Neither protein nor GI affected MetSyn status in this sample of European overweight and obese adults .
CONCLUSIONS	However , a diet with a combination of an increased protein-to-carbohydrate ratio with low-GI foods had beneficial effects on MetSyn factors .

###26206258
OBJECTIVE	To evaluate the optimal time interval from definitive surgery to commencing chemotherapy in early breast cancer ( EBC ) .
METHODS	The relationship between time to initiation of adjuvant chemotherapy ( TTC ) , calculated in weeks , and disease-free ( DFS ) or overall survival ( OS ) , was assessed in 921 EBC patients with rapidly proliferating tumours ( thymidine labelling index > 3 % or G3 or Ki67 > 20 % ) , randomised in a phase III clinical trial ( NCT01031030 ) to receive chemotherapy with or without anthracyclines ( epirubicincyclophosphamide , methotrexate and fluorouracil ( CMF ) versus CMFepirubicin versus CMF ) .
METHODS	DFS , OS and 95 % confidence intervals ( 95 % confidence interval ( CI ) ) were calculated by the Kaplan-Meier method .
METHODS	Multivariate Cox analysis was performed in relation with nodal involvement , oestrogen receptor and human epidermal growth factor receptor 2 ( HER2 ) status , Ki67 value , type of adjuvant chemotherapy , menopausal status and tumour size .
RESULTS	At a median follow-up of 105 months ( range 2-188 ) , a prolonged TTC resulted in a significant increase in the risk of relapse : hazard ratio ( HR ) 1.15 ( 95 % CI 1.02-1 .30 , p = 0.019 ) .
RESULTS	Using a backward elimination procedure , TTC , tumour size and nodal involvement remained significantly associated with DFS .
RESULTS	A time-dependent receiver-operating characteristic ( ROC ) curve analysis was subsequently utilised to evaluate the best cut-off for TTC , identifying 7 weeks as the best threshold for longer OS ( p = 0.043 ) : 8-year OS 88 % ( 95 % CI 85-90 ) for patients with a TTC < 7 weeks and 78 % ( 95 % CI 68-87 ) for the other group .
CONCLUSIONS	Our results confirm that a shorter TTC may reduce relapses and possibly also improve clinical outcome in patients with highly proliferating EBC .

###25514542
OBJECTIVE	The purpose of this study was to evaluate the relative bioavailability and safety of a multilayer extended-release bead methylphenidate ( MPH ) hydrochloride 80mg ( MPH-MLR ) capsule or sprinkles ( 37 % immediate-release [ IR ] ) versus MPH hydrochloride IR ( Ritalin ( ) ) tablets , and to develop a pharmacokinetic ( PK ) model simulating MPH concentration-time data for different MPH-MLR dosage strengths .
METHODS	This was a single-center , randomized , open-label , three-period crossover study conducted in 26 fasted healthy adults ( mean weightstandard deviation , 70.411.7 kg ) assigned to single-dose oral MPH-MLR 80mg capsule or sprinkles with applesauce , or Ritalin IR 25mg ( 15mg and 120mg tablet ) administered at 0 , 4 , and 8 hours .
RESULTS	MPH-MLR 80mg capsule and sprinkles were bioequivalent ; ratios for maximum concentration ( Cmax ) , area under plasma drug concentration versus time curve ( AUC ) 0-t , and AUC0-inf were 1.04 ( 95 % confidence interval [ CI ] , 96.3-112 .4 ) , 0.99 ( 95 % CI , 95.3-102 .8 ) , and 0.99 ( 95 % CI , 95.4-103 .0 ) , respectively .
RESULTS	MPH-MLR capsule/sprinkles produced highly comparable , biphasic profiles of plasma MPH concentrations characterized by rapid initial peak , followed by moderate decline until 5 hours postdose , and gradual increase until 7 hours postdose , culminating in an attenuated second peak .
RESULTS	Based on 90 % CIs , total systemic exposure to MPH-MLR 80mg capsule/sprinkles was similar to that for Ritalin IR 25mg three times daily , but marked differences in Cmax values indicated that MPH-MLR regimens were not bioequivalent to Ritalin .
RESULTS	MPH Cmax and total systemic exposure over the first 4 hours postdose with MPH-MLR capsule/sprinkles was markedly higher than that associated with the first dose of Ritalin .
RESULTS	All study drugs were safe and well tolerated .
RESULTS	The PK modeling in adults suggested that differences in MPH pharmacokinetics between MPH-MLR and Ritalin are the result of dosage form design attributes and the associated absorption profiles of MPH .
CONCLUSIONS	MPH-MLR 80mg provides a long-acting biphasic pattern of plasma MPH concentrations with one less peak and trough than Ritalin IR .

###24297579
OBJECTIVE	The authors evaluated the effect of susceptibility-weighted imaging ( SWI ) for antiplatelet therapy on post-thrombolysis microbleeds ( MB ) .
METHODS	A total of 146 patients without symptomatic intracranial haemorrhage on computed tomography after thrombolysis were allocated to two groups : group A ( n = 72 ) received antiplatelets 24h after recombinant tissue plasminogen activator , regardless of SWI-detected haemorrhage ; group B ( n = 74 ) received antiplatelets for patients without SWI-visualised haemorrhage .
RESULTS	Haemorrhage was detected by SWI in 22 and 28 patients in groups A and B , respectively .
RESULTS	The difference in mean NIHSS ( National Institutes of Health Stroke Scale ) score in group A between baseline and 6 , 24h , 7 , 14days was -1.6 , -1.7 , -3.6 , -5.9 , respectively ; in group B , the difference in mean NIHSS score between baseline and 6 , 24h , 7 , 14days was -2.6 , -3.3 , -5.4 , -8.7 , respectively .
RESULTS	The difference between groups in reduction of mean NIHSS score from baseline was 1.0 ( p < 0.001 ) at 6h , 1.6 ( p < 0.001 ) at 24h , 1.8 ( p = 0.001 ) at 7days and 2.8 ( p < 0.001 ) at 14days .
RESULTS	NIHSS scores at 7 , 14days and modified Rankin scale at 90days were significantly lower in haemorrhage patients in groups B than in A , whereas the hospital stay was shorter and the rate of favourable outcome at 90days was higher .
CONCLUSIONS	Our results indicated that SWI was an effective approach for the guidance of antiplatelet therapy in post-thrombolysis MB .

###24808113
OBJECTIVE	Medication errors can be caused by lack of agreement between what physicians believe patients are taking and what patients actually take .
OBJECTIVE	There has been little systematic research to find the best way to reconcile medication lists in primary care .
OBJECTIVE	The objective of this study was to assess the impact of 2 interventions on agreement between electronic medical record medication lists and what patients report actually taking .
METHODS	This study was a factorial randomized trial that randomized 440 eligible patients ( English-speaking , age 18 and older , taking at least 2 prescriptions ) visiting 20 primary care physicians ; 367 completed the study .
METHODS	Interventions included ( 1 ) providing patients a printed copy of their current medication list at check-in and ( 2 ) beginning the medication review with an open-ended question .
METHODS	Patients were randomized to receive no intervention , one or the other intervention , or both interventions .
METHODS	The outcome measure was agreement on all prescription and nonprescription medications , vitamins , and supplements between the list from the electronic medical record after the visit and a list based on patient report generated during a phone interview within a week of the office visit .
RESULTS	Agreement rates between medication lists and patient report for the 4 study groups were : 67.4 % in the no intervention group , 66.7 % in the printed list only group , 58.1 % in the open-ended question only group , and 75.6 % in the combined intervention group .
RESULTS	Both a printed list and beginning a medication discussion with an open-ended question were required before any significant increase in agreement was observed .
CONCLUSIONS	While neither intervention alone improved medication list agreement , these interventions may have value in a multistep protocol to improve the agreement of medication lists in primary care offices .
CONCLUSIONS	Baseline agreement was much higher than expected , possibly reflecting a Hawthorne effect .

###24770560
BACKGROUND	This study aimed to determine the effectiveness of using a wireless , portable vital signs monitor ( WVSM ) for predicting the need for lifesaving interventions ( LSIs ) in the emergency department ( ED ) and use a multivariate logistic regression model to determine whether the WVSM was an improved predictor of LSIs in the ED over the standard of care monitor currently being used .
METHODS	This study analyzed 305 consecutive patients transported from the scene via helicopter to a Level I trauma center .
METHODS	For 104 patients in the study , a WVSM was also attached to the patient 's arm and used to record and display prehospital and hospital physiologic data in real time on a handheld computer and in the trauma bay .
METHODS	Multivariate logistic regression analyses were performed for accuracy in predicting needs for LSIs in control and WVSM subjects .
METHODS	In addition , receiver operating characteristic curves were obtained to examine the discriminating power of the models for the outcome of one or more LSIs in the ED .
RESULTS	Of the 305 patients , 73 underwent 109 LSIs in the ED .
RESULTS	Of these , 21 patients wore the WVSM during transport in addition to the standard monitor .
RESULTS	Logistic regression analysis revealed that heart rate , respiratory rate , and systolic blood pressure were significantly associated with an increased risk for LSIs in the ED ( p < 0.05 ) .
RESULTS	Receiver operating characteristic curve analysis also demonstrated better prediction for LSIs performed in the ED in WVSM subjects than in control subjects ( area under the curve , 0.86 vs. 0.81 , respectively ) .
CONCLUSIONS	The WVSM system leads to improved LSI accuracy in the ED .
CONCLUSIONS	In addition , many important lessons have been learned in preparation for this study .
CONCLUSIONS	Adoption of nonstandard vital signs monitors into critical care/trauma medicine may require a new paradigm of personnel education , training , and practice .
METHODS	Therapeutic/care management , level IV .

###24535702
OBJECTIVE	Brief potentially ictal rhythmic discharges , termed B ( I ) RDs , have been described mainly in neonates , and their significance in adults remains unclear .
OBJECTIVE	To describe the incidence of B ( I ) RDs in critically ill patients and investigate their association with seizures and outcome .
METHODS	We reviewed the records of prospectively identified patients with B ( I ) RDs and patients serving as controls matched for age ( 5 years ) and primary diagnosis .
METHODS	The prevalence of seizures during continuous electroencephalography and functional outcome , as measured by the Glasgow Outcome Scale , were determined .
RESULTS	We identified B ( I ) RDs in 20 patients ( 2 % ) .
RESULTS	The pattern most often consisted of very brief ( 1-3 seconds ) runs of sharply contoured theta activity without obvious evolution .
RESULTS	All patients with B ( I ) RDs had cerebral injury , and in cases with a single focal lesion ( 11 [ 55 % ] ) , B ( I ) RDs were localized in the same region in all but 2 cases ( 18 % ) .
RESULTS	Patients with B ( I ) RDs were more likely to have seizures during continuous electroencephalography than were patients without B ( I ) RDs ( 15 of 20 [ 75 % ] vs 10 of 40 [ 25 % ] ; P < .001 ) , and 9 patients with B ( I ) RDs ( 60 % ) had only subclinical seizures .
RESULTS	Brief potentially ictal rhythmic discharges were identified before seizures in all but 1 case ( 93 % ) and ceased in all 12 cases ( 80 % ) in which seizures were controlled .
RESULTS	Patients with B ( I ) RDs tended to have a worse outcome than controls ( 16 [ 80 % ] vs 25 [ 63 % ] ) ; however , this finding was not statistically significant .
CONCLUSIONS	Brief potentially ictal rhythmic discharges in critically ill patients are associated with a high prevalence ( 75 % ) of electrographic seizures and might serve as an early predictor of seizures during subsequent monitoring .
CONCLUSIONS	A larger prospective study is needed to better understand their clinical and prognostic significance .

###24290849
OBJECTIVE	To investigate whether strength decline in post-polio syndrome ( PPS ) results from excessive distal axonal degeneration of enlarged motor units .
METHODS	We assessed changes over 10 years in isometric quadriceps strength , mean motor unit action potential ( MUAP ) size , root mean squared ( RMS ) amplitude , and level of interference ( LOI ) in 47 patients with PPS and 12 healthy controls , using high density surface EMG .
METHODS	At baseline , all patients had symptomatic quadriceps dysfunction , evidenced by transmission defects on single-fibre EMG .
RESULTS	MU size and strength declined significantly by 20 % and 15 % , respectively in patients with PPS .
RESULTS	Those with the largest initial MU sizes exhibited the greatest losses of mean MU size ( 27 % ) and proportional decreases in quadriceps strength ( 23 % ) .
RESULTS	Initial strength , change in LOI and change in RMS amplitude together explained 35 % of the variability in strength changes in patients .
RESULTS	MU size of controls did not change , although they lost 29 % strength .
CONCLUSIONS	MU size and strength declined concomitantly in a homogeneous cohort of patients with PPS and quadriceps dysfunction .
CONCLUSIONS	This long term follow-up study provides evidence that size diminution of enlarged MUs combined with a reduced number of active MUs contributes to the gradual strength decline in PPS .

###24284841
BACKGROUND	A high incidence of diabetes mellitus has been reported among patients diagnosed with lumbar degenerative spinal diseases .
BACKGROUND	Although epidural steroid injections are known to increase the postprocedure blood glucose level , it has not been investigated whether a lower steroid dose can reduce blood glucose excursions and still be effective in controlling patients ' subjective pain .
OBJECTIVE	We compared the effects of 2 common doses of triamcinolone administered via epidural steroid injections on blood glucose levels and pain control in patients with diabetes mellitus to determine an adequate epidural steroid dose .
METHODS	A prospective observational study .
METHODS	One hundred patients with diabetes mellitus were enrolled .
METHODS	They received lumbar transforaminal , lumbar interlaminar , or caudal epidural triamcinolone for radiculopathy , spinal stenosis , or failed back surgery syndrome .
METHODS	After the type of procedure was clinically determined , the doses of triamcinolone given were randomly chosen , either 40 mg ( Group 40 ) or 20 mg ( Group 20 ) .
METHODS	The patients were asked to measure their finger stick blood glucose level twice daily ( fasting and postprandial ) for 3 days before the injection , on the day of the injection , for 7 days after the injection , and at 14 days after the injection .
METHODS	They also kept a blood glucose diary .
METHODS	Employment status and clinical outcome were evaluated at 8 weeks after the procedure .
RESULTS	There were significant increases in fasting blood glucose ( FBG ) level on postprocedure day ( PPD ) # 1 to PPD # 3 in Group 40 , but on PPD # 1 in Group 20 .
RESULTS	Moreover , there was a significant difference in FBG between groups on PPD # 1 and PPD # 2 ( FBG on PPD # 1 : 179 [ 51 ] ) mg/dL in Group 40 versus 146 [ 50 ] mg/dL in Group 20 , P < 0.001 ] .
RESULTS	Postprandial blood glucose ( PBG ) level was significantly elevated in both groups from PPD # 0 to PPD # 3 .
RESULTS	Notably , the increase in PBG was significantly greater in Group 40 than Group 20 on PPD # 0 and # 1 ( PBG on PPD # 0 : 288 [ 57 ] mg/dL versus 242 [ 94 ] mg/dL in Groups 40 and 20 , respectively , P = 0.004 ) .
RESULTS	The numeric rating scale for pain reported by the patients decreased for 2 weeks after treatment with no difference between groups .
RESULTS	Employment status and clinical outcome was not different between groups .
CONCLUSIONS	The patients who chose to participate in this study may be a cohort of well-controlled patients with diabetes mellitus .
CONCLUSIONS	The type of procedure performed was determined by a clinical decision and not randomized .
CONCLUSIONS	The different routes of administration and diagnosis of failed back surgery syndrome can result in different levels of systemic absorption , thereby influencing the degree and duration of hyperglycemia .
CONCLUSIONS	In patients with FBSS , the epidural space may be destructed by surgery and adhesive changes in epidural space could be extensive .
CONCLUSIONS	Therefore , we thought that the absorption of epidural space in these patients would be incomplete or slow compared with those without FBSS .
CONCLUSIONS	Epidural steroid injections were associated with statistically significant elevations in PBG in patients with diabetes for up to 4 days after the procedure .
CONCLUSIONS	The higher dose of triamcinolone increased FBG and PBG greater than a lower dose did without affecting pain control , employment status , or clinical outcome .
CONCLUSIONS	Thus , with respect to glucose and pain control , 20 mg of triamcinolone appears to be recommended rather than 40 mg in patients with diabetes .
CONCLUSIONS	Clinical Trials registration : NCT01435707 .

###24261693
BACKGROUND	The CORONIS Trial was a 22222 non-regular , fractional , factorial trial of five pairs of alternative caesarean section surgical techniques on a range of short-term outcomes , the primary outcome being a composite of maternal death or infectious morbidity .
BACKGROUND	The consequences of different surgical techniques on longer term outcomes have not been well assessed in previous studies .
BACKGROUND	Such outcomes include those related to subsequent pregnancy : mode of delivery ; abnormal placentation ( e.g. accreta ) ; postpartum hysterectomy , as well as longer term pelvic problems : pain , urinary problems , infertility .
BACKGROUND	The Coronis Follow-up Study aims to measure and compare the incidence of these outcomes between the randomised groups at around three years after women participated in the CORONIS Trial .
METHODS	This study will assess the following null hypotheses : In women who underwent delivery by caesarean section , no differences will be detected with respect to a range of long-term outcomes when comparing the following five pairs of alternative surgical techniques evaluated in the CORONIS Trial : 1 .
METHODS	Blunt versus sharp abdominal entry .
METHODS	2 .
METHODS	Exteriorisation of the uterus for repair versus intra-abdominal repair .
METHODS	3 .
METHODS	Single versus double layer closure of the uterus .
METHODS	4 .
METHODS	Closure versus non-closure of the peritoneum ( pelvic and parietal ) .
METHODS	5 .
METHODS	Chromic catgut versus Polyglactin-910 for uterine repair .
METHODS	The outcomes will include ( 1 ) women 's health : pelvic pain ; dysmenorrhoea ; deep dyspareunia ; urinary symptoms ; laparoscopy ; hysterectomy ; tubal/ovarian surgery ; abdominal hernias ; bowel obstruction ; infertility ; death .
METHODS	( 2 ) Outcomes of subsequent pregnancies : inter-pregnancy interval ; pregnancy outcome ; gestation at delivery ; mode of delivery ; pregnancy complications ; surgery during or following delivery .
CONCLUSIONS	The results of this follow-up study will have importance for all pregnant women and for health professionals who provide care for pregnant women .
CONCLUSIONS	Although the results will have been collected in seven countries with limited health care resources ( Argentina , Chile , Ghana , India , Kenya , Pakistan , Sudan ) any differences in outcomes associated with different surgical techniques are likely to be generalisable throughout the world .
BACKGROUND	ISRCTN31089967 .

###25479050
BACKGROUND	Psychosocial interventions for bipolar disorder are frequently unavailable and resource intensive .
BACKGROUND	Mobile technology may improve access to evidence-based interventions and may increase their efficacy .
BACKGROUND	We evaluated the feasibility , acceptability and efficacy of an augmentative mobile ecological momentary intervention targeting self-management of mood symptoms .
METHODS	This was a randomized single-blind controlled trial with 82 consumers diagnosed with bipolar disorder who completed a four-session psychoeducational intervention and were assigned to 10 weeks of either : 1 ) mobile device delivered interactive intervention linking patient-reported mood states with personalized self-management strategies , or 2 ) paper-and-pencil mood monitoring .
METHODS	Participants were assessed at baseline , 6 weeks ( mid-point ) , 12 weeks ( post-treatment ) , and 24 weeks ( follow up ) with clinician-rated depression and mania scales and self-reported functioning .
RESULTS	Retention at 12 weeks was 93 % and both conditions were associated with high satisfaction .
RESULTS	Compared to the paper-and-pencil condition , participants in the augmented mobile intervention condition showed significantly greater reductions in depressive symptoms at 6 and 12 weeks ( Cohens d for both were d = 0.48 ) .
RESULTS	However , these effects were not maintained at 24-weeks follow up .
RESULTS	Conditions did not differ significantly in the impact on manic symptoms or functional impairment .
CONCLUSIONS	This was not a definitive trial and was not powered to detect moderators and mediators .
CONCLUSIONS	Automated mobile-phone intervention is feasible , acceptable , and may enhance the impact of brief psychoeducation on depressive symptoms in bipolar disorder .
CONCLUSIONS	However , sustainment of gains from symptom self-management mobile interventions , once stopped , may be limited .

###26299230
BACKGROUND	The incidence of end-stage renal disease ( ESRD ) has been consistently shown to be higher among blacks and Hispanics compared to whites with unmeasured risk factors and access to care as suggested explanations .
BACKGROUND	In a high-risk cohort with frequent protocol-directed follow-up , we evaluated the influence of race on cardiovascular ( CV ) outcomes and incidence of ESRD .
METHODS	TREAT was a randomized , double-blind , placebo-controlled study .
METHODS	This secondary analysis focused on role of race on outcomes .
METHODS	TREAT enrolled 4,038 patients with type 2 diabetes , chronic kidney disease ( estimated glomerular filtration rate 20-60 mL/min per 1.73 m ( 2 ) ) , and anemia ( hemoglobin level 11 g/dL ) treated with either darbepoetin alfa or placebo .
METHODS	We compared self-described black and Hispanic patients to white patients with regard to baseline characteristics and outcomes , including mortality , CV outcomes ( myocardial infarction , stroke , heart failure , resuscitated sudden death , and coronary revascularization ) , and incident ESRD .
METHODS	Multivariate adjusted Cox models were developed for these outcomes .
RESULTS	Black and Hispanic patients were younger , more likely women , had less prior CV disease , and higher blood pressure .
RESULTS	During a mean follow-up of 2.4 years with comparable access to care , blacks and Hispanics had a greater risk of ESRD but a significant lower risk of myocardial infarction and coronary revascularization than whites .
RESULTS	After adjusting for confounders , blacks remained at significantly greater risk of ESRD than whites ( hazard ratio 1.53 , 95 % CI 1.26-1 .85 , P < .001 ) , whereas this ESRD risk did not persist among Hispanics .
CONCLUSIONS	Despite similar access to care and lower CV event rates , the risk of ESRD was higher among blacks and Hispanics than whites .
CONCLUSIONS	For blacks , but not Hispanics , this increase was independent of known attributable risk factors .

###25595234
BACKGROUND	Generic preference-based measures were criticized for being inappropriate in some conditions .
BACKGROUND	One solution is to include `` bolt-on '' dimensions describing additional specific health problems .
OBJECTIVE	This study aimed to develop bolt-on dimensions to the EuroQol five-dimensional questionnaire ( EQ-5D ) and assess their impact on health state values .
METHODS	Bolt-on dimensions were developed for vision problems , hearing problems , and tiredness .
METHODS	Each bolt-on dimension had three severity levels to match the EQ-5D .
METHODS	Three `` core '' EQ-5D states across a range of severity were selected , and each level of a bolt-on item was added , resulting in nine states in each condition .
METHODS	Health states with and without the bolt-on dimensions were valued by 300 members of the UK general public using time trade-off in face-to-face interviews , and mean health state values were compared using t tests .
METHODS	Regression analysis examined the impact of the bolt-on variants and the level of the bolt-on items after controlling for sociodemographic characteristics .
RESULTS	Bolt-on dimensions had an impact on health state values of the EQ-5D ; however , the size , direction , and significance of the impact depend on the severity of the core EQ-5D state and of the bolt-on dimension .
RESULTS	Regression analysis demonstrated that after controlling for possible differences in sociodemographic characteristics between the groups , there were no significant differences in health state values between the three bolt-on dimensions but confirmed that the impact depended on the severity of the EQ-5D health state and the levels of bolt-on dimensions .
CONCLUSIONS	The impact of a bolt-on dimension on the EQ-5D depends on the core health state and the level of the bolt-on dimension .
CONCLUSIONS	Further research in this area is encouraged .

###25624390
BACKGROUND	Studies suggest that giving newly born preterm infants sustained lung inflation ( SLI ) may decrease their need for mechanical ventilation ( MV ) and improve their respiratory outcomes .
METHODS	We randomly assigned infants born at 25 weeks 0 days to 28 weeks 6 days of gestation to receive SLI ( 25 cm H2O for 15 seconds ) followed by nasal continuous positive airway pressure ( nCPAP ) or nCPAP alone in the delivery room .
METHODS	SLI and nCPAP were delivered by using a neonatal mask and a T-piece ventilator .
METHODS	The primary end point was the need for MV in the first 72 hours of life .
METHODS	The secondary end points included the need for respiratory supports and survival without bronchopulmonary dysplasia ( BPD ) .
RESULTS	A total of 148 infants were enrolled in the SLI group and 143 in the control group .
RESULTS	Significantly fewer infants were ventilated in the first 72 hours of life in the SLI group ( 79 of 148 [ 53 % ] ) than in the control group ( 93 of 143 [ 65 % ] ) ; unadjusted odds ratio : 0.62 [ 95 % confidence interval : 0.38-0 .99 ] ; P = .04 ) .
RESULTS	The need for respiratory support and survival without BPD did not differ between the groups .
RESULTS	Pneumothorax occurred in 1 % ( n = 2 ) of infants in the control group compared with 6 % ( n = 9 ) in the SLI group , with an unadjusted odds ratio of 4.57 ( 95 % confidence interval : 0.97-21 .50 ; P = .06 ) .
CONCLUSIONS	SLI followed by nCPAP in the delivery room decreased the need for MV in the first 72 hours of life in preterm infants at high risk of respiratory distress syndrome compared with nCPAP alone but did not decrease the need for respiratory support and the occurrence of BPD .

###26168497
OBJECTIVE	This study aimed to evaluate the efficacy of aprepitant , a neurokinin ( NK ) 1 receptor antagonist , on chemotherapy-induced nausea and vomiting ( CINV ) .
METHODS	A randomized , open-labeled , parallel-design study was undertaken in gynecologic-cancer ( GC ) patients at the Fukuoka University Hospital .
METHODS	Twenty-three patients were divided into without ( group A ) or with aprepitant ( Group B ) in the first cycle of paclitaxel and carboplatin ( TC ) therapy .
METHODS	From the second cycle onwards , all patients used aprepitant .
METHODS	Statistical significance was assessed using McNemar and Chi-square tests .
RESULTS	In the first cycle , the prevalence of a complete response , no episodes of nausea or food intake in group B was significantly increased compared to group A. No significant difference in the prevalence of a complete response or food intake situation was found from the second cycle onwards .
CONCLUSIONS	Combination of aprepitant with standard anti-emetic therapy may contribute to prevention of CINV in TC therapy for GC patients .

###25204479
BACKGROUND	Pemphigus is an autoimmune blistering mucocutaneous disorder .
BACKGROUND	Common treatments include corticosteroids and immunosuppressive drugs .
BACKGROUND	This study aimed to assess the therapeutic effects of oral prednisolone along with the common adjuvant therapy in pemphigus vulgaris .
METHODS	Eighty-seven patients with pemphigus vulgaris from the first stage of a previously randomized clinical trial were enrolled in the present non-blinded clinical trial .
METHODS	The patients were divided into four groups and treated accordingly with prednisolone alone ( P ; N = 23 ) , prednisolone and azathioprine ( P/A ; N = 23 ) , prednisolone and mycophenolate mofetil ( P/M ; N = 21 ) , and prednisolone and cyclophosphamide ( P/C ; N = 20 ) .
METHODS	These patients were followed-up for an extended one-year period .
RESULTS	The primary localization of the recurrence occurred in the oral cavity of 7 , 6 , 2 , and 5 patients in the P , P/A , P/M , and P/C groups , respectively .
RESULTS	There was no significant difference between them ( P = 0.40 ) .
RESULTS	The mean total dose of prednisolone administered in groups P , P/A , P/M , and P/C was accordingly 7.5 , 8.4 , 9.2 , and 8.6 mg/day .
RESULTS	Minor recurrence of the disease in the above-mentioned groups was observed in 7 ( 30.4 % ) , 5 ( 21.7 % ) , 6 ( 28.6 % ) , and 7 ( 35.0 % ) of the patients , respectively .
RESULTS	With regard to the minor recurrence of the disease , there was no significant difference among the four treatment groups ( P = 0.80 ) .
CONCLUSIONS	Since in this follow-up study no therapeutic benefit of oral prednisolone and common adjuvant therapy was found in terms of the number of minor and major recurrences , the extent to which treatment of PV can be improved upon treatment with these agents remains to be elucidated .

###26387408
OBJECTIVE	The purpose of this study was to investigate the immediate effects of traditional Thai massage ( TTM ) on psychological stress and heart rate variability ( HRV ) .
METHODS	Thirty healthy participants were randomly allocated in two groups , a TTM group ( n = 15 ) who received a 1-hour session with moderate pressure of whole body TTM or a control group ( n = 15 ) who rested on the bedfor 1 hour All ofthem were given a 10-minute mental arithmetic test to induce psychological stress after which they received a 1-hour session of TTM or bed rest .
METHODS	Psychological stress and HR V were measured at baseline and immediately after mental arithmetic test , and immediately after TTM or bed rest .
RESULTS	The studyfound that psychological stress was signficantly increased ( p < 0.05 ) after mental arithmetic test in both groups .
RESULTS	Comparison on these measures between immediately after mental arithmetic test and after TTM or bed rest revealed that psychological stress was significantly decreased ( p < 0.05 ) and HR Vwas significantly increased ( p < 0.05 ) in both groups .
RESULTS	Root mean square of successive differences ( RMSSD ) and low frequency were significantly increased ( p < 0.05 ) only in the TTM group .
RESULTS	However ; all of these measures were found without significant difference when groups were compared .
CONCLUSIONS	TTM and bed rest could decrease psychological stress and HRV

###25004196
BACKGROUND	More than a third of the approximately 10 million women with histories of interpersonal violence in the United States develop posttraumatic stress disorder ( PTSD ) .
BACKGROUND	Currently available treatments for this population have a high rate of incomplete response , in part because problems in affect and impulse regulation are major obstacles to resolving PTSD .
BACKGROUND	This study explored the efficacy of yoga to increase affect tolerance and to decrease PTSD symptomatology .
METHODS	Sixty-four women with chronic , treatment-resistant PTSD were randomly assigned to either trauma-informed yoga or supportive women 's health education , each as a weekly 1-hour class for 10 weeks .
METHODS	Assessments were conducted at pretreatment , midtreatment , and posttreatment and included measures of DSM-IV PTSD , affect regulation , and depression .
METHODS	The study ran from 2008 through 2011 .
RESULTS	The primary outcome measure was the Clinician-Administered PTSD Scale ( CAPS ) .
RESULTS	At the end of the study , 16 of 31 participants ( 52 % ) in the yoga group no longer met criteria for PTSD compared to 6 of 29 ( 21 % ) in the control group ( n = 60 , = 6.17 , P = .013 ) .
RESULTS	Both groups exhibited significant decreases on the CAPS , with the decrease falling in the large effect size range for the yoga group ( d = 1.07 ) and the medium to large effect size decrease for the control group ( d = 0.66 ) .
RESULTS	Both the yoga ( b = -9.21 , t = -2.34 , P = .02 , d = -0.37 ) and control ( b = -22.12 , t = -3.39 , P = .001 , d = -0.54 ) groups exhibited significant decreases from pretreatment to the midtreatment assessment .
RESULTS	However , a significant group quadratic trend interaction ( d = -0.34 ) showed that the pattern of change in Davidson Trauma Scale significantly differed across groups .
RESULTS	The yoga group exhibited a significant medium effect size linear ( d = -0.52 ) trend .
RESULTS	In contrast , the control group exhibited only a significant medium effect size quadratic trend ( d = 0.46 ) but did not exhibit a significant linear trend ( d = -0.29 ) .
RESULTS	Thus , both groups exhibited significant decreases in PTSD symptoms during the first half of treatment , but these improvements were maintained in the yoga group , while the control group relapsed after its initial improvement .
CONCLUSIONS	Yoga significantly reduced PTSD symptomatology , with effect sizes comparable to well-researched psychotherapeutic and psychopharmacologic approaches .
CONCLUSIONS	Yoga may improve the functioning of traumatized individuals by helping them to tolerate physical and sensory experiences associated with fear and helplessness and to increase emotional awareness and affect tolerance .
BACKGROUND	ClinicalTrials.gov identifier : NCT00839813 .

###24700260
OBJECTIVE	Nausea and vomiting ( NV ) related to DMSO affect patients undergoing auto-SCT despite antiemetic measures .
OBJECTIVE	Orange flavoring may reduce gastrointestinal symptoms .
METHODS	A multicenter , randomized , three-arm , open-label trial in four Italian large bone marrow transplant centers was conducted to assess the effectiveness of orange aroma in preventing NV related to DMSO .
METHODS	Patients were randomized to orange ice lollies , non-citrus ice lollies , and routine treatment ( deep breaths ) during reinfusion .
METHODS	Data on NV were collected up to 5days after infusion ; 69/98 patients were randomized : 23 to orange , 21 to non-citrus ice lollies , and 25 to routine treatment .
RESULTS	Although 48h after transplantation no differences were observed in controlled nausea ( Numerical Rating Scale ( NRS ) 0-100 , 25 ) or vomiting , significantly fewer patients had no episodes of vomiting , no antiemetic rescue therapy , and no nausea ( NRS < 5 ) in the deep breath vs lollies groups ( P = 0.017 ) .
RESULTS	The intensity of nausea over time differed significantly between ice lollies vs routine care ( P = 0.001 ) groups , but not between the orange and non-citrus groups ( P = 0.428 ) .
CONCLUSIONS	The vasoconstrictive action of ice may prevent NV related to DMSO in the acute phase and reduce the need for rescue antiemetic therapy .
CONCLUSIONS	Ice lollies offer a simple , noninvasive , and economic means for relieving nausea and vomiting related to this preservative .

###24807339
OBJECTIVE	To compare the efficacy of the vaginal and sublingual administration of the synthetic prostaglandin misoprostol with the currently used oral administration route in second-trimester medical abortion .
METHODS	This was a prospective randomized trial of medical abortion with misoprostol after mifepristone priming at 14-24 weeks of gestation .
METHODS	From 2009 to 2013 , recruited women received 200 mg mifepristone orally followed 24-48 hours later by an 800-microgram vaginal loading dose of misoprostol .
METHODS	Women were then randomized to receive additional 400-microgram misoprostol doses orally every 3 hours , vaginally every 4 hours , or sublingually every 3 hours .
METHODS	The main outcome was the duration of abortion with emphasis on the proportion of women undelivered 12 hours after the misoprostol loading dose in the three groups .
RESULTS	A total of 302 women were randomized : 100 to oral , 100 to vaginal , and 102 to sublingual misoprostol .
RESULTS	The median gestation at recruitment was oral 19.1 weeks ( interquartile range 17.2-20 .8 ) , vaginal 19.4 weeks ( interquartile range 17.3-20 .4 ) , and sublingual 19.7 weeks ( interquartile range 17.6-21 .0 ) .
RESULTS	The overall abortion duration was longer in women receiving oral misoprostol : oral 9.5 hours ( 95 % confidence interval [ CI ] 8.5-11 .4 ) , vaginal 7.4 hours ( 95 % CI 6.5-8 .2 ) , and sublingual 7.8 hours ( 95 % CI 7.0-9 .2 ) .
RESULTS	Overall , 84 of 302 ( 27.8 % ) women were undelivered at 12 hours , comprising 37.0 % ( 95 % CI 28.7-47 .8 ) oral , 20.5 % ( 95 % CI 14.0-30 .1 ) vaginal , and 21.0 % ( 95 % CI 14.3-30 .7 ) sublingual groups .
CONCLUSIONS	Vaginal or sublingual misoprostol administered after a vaginal loading dose in second-trimester medical abortion with mifepristone priming is associated with a shorter time to pregnancy termination compared with an oral regimen .
BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT00864799 .
METHODS	I.

###25306200
BACKGROUND	IPX066 , an investigational extended-release carbidopa-levodopa ( CD-LD ) preparation , has demonstrated a rapid attainment and prolonged maintenance of therapeutic LD plasma concentrations in advanced Parkinson 's disease ( PD ) .
BACKGROUND	This phase-3 crossover study assessed its efficacy and safety vs. CD-LD plus entacapone ( CL+E ) .
METHODS	At baseline , all patients had motor fluctuations despite a stable regimen of CL+E or CD-LD-entacapone combination tablets ( CLE ) .
METHODS	The study included a 6-week conversion from CL+E or CLE to IPX066 , followed by two 2-week , double-blind crossover treatment periods in randomized order , one on IPX066 ( and placebo CL+E ) , the other on CL+E ( and placebo IPX066 ) , separated by 1-week open-label IPX066 treatment .
METHODS	The primary efficacy measure was mean percent daily `` off '' time during waking hours ( from patient diaries ) .
RESULTS	Of 91 randomized patients , 84 completed the study .
RESULTS	Their median daily LD dosage was 1495mg from IPX066 and 600mg from CL+E , corresponding , after correction for bioavailability , to an approximately 22 % higher LD exposure on IPX066 .
RESULTS	Compared with CL+E , IPX066 demonstrated a lower percent `` off '' time ( 24.0 % vs. 32.5 % ; p < 0.0001 ) , lower `` off '' time ( 3.8 vs. 5.2 h/day ; p < 0.0001 ) , and higher `` on '' time without troublesome dyskinesia ( 11.4 vs. 10.0 h/day ; p < 0.0001 ) .
RESULTS	Other endpoints , including patient-reported treatment preference , also favored IPX066 ( p < 0.05 ) .
RESULTS	During double-blind treatment , 20.2 % and 13.6 % of patients reported adverse events on IPX066 and CL+E , respectively .
RESULTS	The most common were dyskinesia ( 4 patients ) , insomnia ( 3 ) , and confusional state ( 3 ) for IPX066 , and fall ( 2 ) for CL+E .
CONCLUSIONS	In advanced PD , IPX066 showed improved efficacy , compared with CL+E , and appeared to be well tolerated .

###25433982
OBJECTIVE	To measure the psychosocial consequences in the Danish lung cancer screening trial ( DLCST ) and compare those between the computed tomography ( CT ) group and the control group .
METHODS	This study was a single centre randomised controlled trial with five annual screening rounds .
METHODS	Healthy current or former heavy smokers aged 50-70 years ( men and women ) were randomised 1:1 to a CT group and a control group .
METHODS	Heavy smokers were defined by having smoked 20 pack years and former smokers by being abstinent 10 years .
METHODS	Both groups were invited annually to the screening clinic to complete the validated lung-cancer-specific questionnaire consequences of screening lung cancer ( COS-LC ) .
METHODS	The CT group was also offered a low dose CT scan of the lungs .
METHODS	The COS-LC measures nine scales with psychosocial properties : Anxiety , Behaviour , Dejection , Negative impact on sleep , Self-blame , Focus on Airway Symptoms , Stigmatisation , Introvert , and Harm of Smoking .
RESULTS	4104 participants were randomised to the DLCST and the COS-LC completion rates for the CT group and the control group were 95.5 % and 73.6 % , respectively .
RESULTS	There was a significant increase in negative psychosocial consequences from baseline through rounds 2-5 for both the CT group and the control group ( mean increase > 0 , p < .0001 for 3 of 4 possible scales ) .
RESULTS	During rounds 2-5 the control group experienced significantly more negative psychosocial consequences in seven of nine scales compared with the CT group ( mean score > 0 and p < .033 ) .
CONCLUSIONS	Lung cancer CT-screening trials induced more negative psychosocial reactions in both the CT group and the control group compared with the baseline psychosocial profile .
CONCLUSIONS	The CT group experienced less negative psychosocial consequences compared with the control group , which might be explained by reassurance among those with normal screening results .
BACKGROUND	ClinicalTrials.gov : NCT00496977 .

###24794369
OBJECTIVE	Maternal immunization with tetanus toxoid , reduced diphtheria toxoid , and acellular pertussis ( Tdap ) vaccine could prevent infant pertussis .
OBJECTIVE	To evaluate the safety and immunogenicity of Tdap immunization during pregnancy and its effect on infant responses to diphtheria and tetanus toxoids and acellular pertussis ( DTaP ) vaccine .
METHODS	Phase 1-2 , randomized , double-blind , placebo-controlled , clinical trial conducted from 2008 to 2012 .
METHODS	Forty-eight pregnant women aged 18 to 45 years received Tdap ( n = 33 ) or placebo ( n = 15 ) at 30 to 32 weeks ' gestation , with crossover immunization postpartum .
METHODS	Tdap vaccination at 30 to 32 weeks ' gestation or postpartum .
METHODS	Primary outcomes were maternal and infant adverse events , pertussis illness , and infant growth and development until age 13 months .
METHODS	Secondary outcomes were antibody concentrations in pregnant women before and 4 weeks after Tdap immunization or placebo , at delivery and 2 months ' postpartum , and in infants at birth , at 2 months , and after the third and fourth doses of DTaP .
RESULTS	No Tdap-associated serious adverse events occurred in women or infants .
RESULTS	Injection site reactions after Tdap immunization were reported in 26 ( 78.8 % [ 95 % CI , 61.1 % -91.0 % ] ) and 12 ( 80 % [ 95 % CI , 51.9 % -95.7 % ] ) pregnant and postpartum women , respectively ( P > .99 ) .
RESULTS	Systemic symptoms were reported in 12 ( 36.4 % [ 95 % CI , 20.4 % -54.9 % ] ) and 11 ( 73.3 % [ 95 % CI , 44.9 % -92.2 % ] ) pregnant and postpartum women , respectively ( P = .03 ) .
RESULTS	Growth and development were similar in both infant groups .
RESULTS	No cases of pertussis occurred .
RESULTS	Significantly higher concentrations of pertussis antibodies were measured at delivery in women who received Tdap during pregnancy vs postpartum ( eg , pertussis toxin antibodies : 51.0 EU/mL [ 95 % CI , 37.1-70 .1 ] and 9.1 EU/mL [ 95 % CI , 4.6-17 .8 ] , respectively ; P < .001 ) and in their infants at birth ( 68.8 EU/mL [ 95 % CI , 52.1-90 .8 ] and 14.0 EU/mL [ 95 % CI , 7.3-26 .9 ] , respectively ; P < .001 ) and at age 2 months ( 20.6 EU/mL [ 95 % CI , 14.4-29 .6 ] and 5.3 EU/mL [ 95 % CI , 3.0-9 .4 ] , respectively ; P < .001 ) .
RESULTS	Antibody responses in infants born to women receiving Tdap during pregnancy were not different following the fourth dose of DTaP .
CONCLUSIONS	This preliminary assessment did not find an increased risk of adverse events among women who received Tdap vaccine during pregnancy or their infants .
CONCLUSIONS	For secondary outcomes , maternal immunization with Tdap resulted in high concentrations of pertussis antibodies in infants during the first 2 months of life and did not substantially alter infant responses to DTaP .
CONCLUSIONS	Further research is needed to provide definitive evidence of the safety and efficacy of Tdap immunization during pregnancy .
BACKGROUND	clinicaltrials.gov Identifier : NCT00707148 .

###24568907
OBJECTIVE	To investigate the effects of Huangqi injection on the infection factors in children with acute lymphoblastic leukemia ( ALL ) during remission induction chemotherapy .
METHODS	Ninety-one children with ALL were divided into treatment ( n = 47 ) and control groups ( n = 44 ) by a randomized double-blind method .
METHODS	During remission induction chemotherapy , the treatment group was given Huangqi injection ( 0.5 mL/kgd ) for 35 days , while an equal volume of normal saline was used instead in the control group ; the other supportive care was the same for the two groups .
METHODS	After remission induction chemotherapy , the incidence of infection , duration of infection , white blood cell and neutrophil counts , site of infection , and positive rate of pathogenic bacteria in secretion were compared between the two groups .
RESULTS	Four cases in the treatment group dropped out of the study due to allergic reaction .
RESULTS	After remission induction chemotherapy , compared with the control group , the treatment group had a significantly lower incidence of infection ( P < 0.05 ) , a shorter duration of infection at any site ( P < 0.05 ) , a higher neutrophil count after chemotherapy ( P < 0.05 ) , and lower incidence rates of respiratory tract infection , urinary tract infection , blood infection , and skin and soft tissue infections ( P < 0.05 ) .
RESULTS	Gram-negative bacteria were the main pathogens .
RESULTS	Among the infected children , the positive rate of pathogenic bacteria in secretion was significantly lower in the treatment group than in the control group ( P < 0.05 ) .
CONCLUSIONS	Huangqi injection may reduce bone marrow suppression caused by chemotherapy drugs and increase neutrophil count during remission induction chemotherapy to reduce the incidence and duration of infection in children with ALL .

###25459036
OBJECTIVE	This study sought to determine whether outcomes for transfemoral ( TF ) transcatheter aortic valve replacement ( TAVR ) differ between the randomized controlled trial ( RCT ) and the subsequent NRCA ( Nonrandomized Continued Access ) registry of the PARTNER ( Placement of AoRTic TraNscathetER Valves ) trial .
BACKGROUND	The PARTNER RCT demonstrated that TAVR with the Edwards Sapien valve ( Edwards Lifesciences , Irvine , California ) is noninferior to surgery in high-risk patients and superior to standard therapy for inoperable patients .
METHODS	The inclusion and exclusion criteria , data collection , monitoring , and core laboratories were the same for the RCT and NRCA registry .
METHODS	Baseline characteristics , procedural results , and 1-year outcomes were compared between patients undergoing TF-TAVR as part of the RCT and as part of the NRCA registry .
RESULTS	In the RCT , 415 patients underwent TF-TAVR , whereas in the NRCA , 1,023 patients did .
RESULTS	At 30 days , death , cardiac death , stroke , and transient ischemic attacks were not different in the NRCA registry than in the RCT .
RESULTS	Major vascular complications ( 8.0 % vs. 15.7 % , p < 0.0001 ) and major bleeding ( 6.8 % vs. 15.3 % , p < 0.0001 ) were significantly lower in the NRCA registry .
RESULTS	At 1 year , death rates were significantly lower in the NRCA cohort ( 19.0 % vs. 25.3 % , p = 0.009 ) and cardiac death tended to be lower ( 8.4 % vs. 11.1 % , p = 0.12 ) .
RESULTS	Stroke or transient ischemic attack ( 6.2 % vs. 8.7 % , p = 0.10 ) and stroke alone ( 5.0 % vs. 7.1 % , p = 0.13 ) also tended to be lower .
CONCLUSIONS	The large NRCA registry demonstrates further improvement in procedural and longer-term outcomes after TF-TAVR when compared with the favorable results from the PARTNER RCT .
CONCLUSIONS	( THE PARTNER TRIAL : Placement of AoRTic TraNscathetER Valve Trial ; NCT00530894 ) .

###25732157
OBJECTIVE	Three small retrospective studies have suggested that patients undergoing continuous androgen deprivation ( CAD ) have superior survival and time to progression if lower castrate levels of testosterone ( < 0.7 nmol/L ) are achieved .
OBJECTIVE	Evidence from prospective large studies has been lacking .
METHODS	The PR-7 study randomly assigned patients experiencing biochemical failure after radiation therapy or surgery plus radiation therapy to CAD or intermittent androgen deprivation .
METHODS	The relationship between testosterone levels in the first year and cause-specific survival ( CSS ) and time to androgen-independent progression in men in the CAD arm was evaluated using Cox regression .
RESULTS	There was a significant difference in CSS ( P = .015 ) and time to hormone resistance ( P = .02 ) among those who had first-year minimum nadir testosterone 0.7 , > 0.7 to 1.7 , and 1.7 nmol/L .
RESULTS	Patients with first-year nadir testosterone consistently > 0.7 nmol/L had significantly higher risks of dying as a result of disease ( 0.7 to 1.7 nmol/L : hazard ratio [ HR ] , 2.08 ; 95 % CI , 1.28 to 3.38 ; > 1.7 nmol/L : HR , 2.93 ; 95 % CI , 0.70 to 12.30 ) and developing hormone resistance ( 0.7 to 1.7 nmol/L : HR , 1.62 ; 95 % CI , 1.20 to 2.18 ; 1.7 nmol/L : HR , 1.90 ; 95 % CI , 0.77 to 4.70 ) .
RESULTS	Maximum testosterone 1.7 nmol/L predicted for a higher risk of dying as a result of disease ( P = .02 ) .
CONCLUSIONS	Low nadir serum testosterone ( ie , < 0.7 mmol/L ) within the first year of androgen-deprivation therapy correlates with improved CSS and duration of response to androgen deprivation in men being treated for biochemical failure undergoing CAD .

###25525051
BACKGROUND	Despite vaccination , residents of long-term-care facilities ( LTCFs ) remain at high risk of influenza-related morbidity and mortality .
BACKGROUND	More-effective vaccine options for this population are needed .
METHODS	We conducted a single-blinded , randomized , controlled trial comparing high-dose ( HD ) to standard-dose ( SD ) inactivated influenza vaccine ( IIV ) in 205 frail , elderly residents of LTCFs during the 2011-2012 and 2012-2013 influenza seasons .
METHODS	Hemagglutination inhibition ( HI ) antibody titers were measured at baseline and 30 and 180 days following vaccination .
RESULTS	A total of 187 subjects ( 91 % ) completed the study .
RESULTS	The mean age was 86.7 years .
RESULTS	Geometric mean titers ( GMTs ) were significantly higher ( P < .05 ) at day 30 for HD recipients , compared with SD recipients , for all comparisons except influenza A ( H1N1 ) during 2012-2013 ( the HD formulation was noninferior to the SD formulation for influenza A [ H1N1 ] during 2012-2013 ) .
RESULTS	GMTs for HD and SD recipients during 2011-2012 were as follows : influenza A ( H1N1 ) , 78 ( 95 % confidence interval [ CI ] , 45-136 ) and 27 ( 95 % CI , 17-44 ) , respectively ; influenza A ( H3N2 ) , 26 ( 95 % CI , 17-40 ) and 10 ( 95 % CI , 7-15 ) , respectively ; and influenza B , 26 ( 95 % CI , 19-35 ) and 14 ( 95 % CI , 11-18 ) , respectively .
RESULTS	During 2012-2013 , GMTs for HD and SD recipients were as follows : influenza A ( H1N1 ) , 46 ( 95 % CI , 33-63 ) and 50 ( 95 % CI , 37-67 ) ; influenza A ( H3N2 ) , 23 ( 95 % CI , 18-31 ) and 14 ( 95 % CI , 11-18 ) , respectively ; and influenza B , 26 ( 95 % CI , 21-32 ) and 17 ( 95 % CI , 14-22 ) , respectively .
RESULTS	GMTs were significantly higher at day 180 for HD recipients , compared with SD recipients , for influenza A ( H3N2 ) in both years ( P < .001 ) .
CONCLUSIONS	Among frail , elderly residents of LTCFs , HD influenza vaccine produced superior responses for all strains except influenza A ( H1N1 ) in 2012-2013 .
BACKGROUND	NCT01654224 .

###24874474
BACKGROUND	Preoperative radiotherapy ( RT ) is widely used to downstage rectal tumours , but the rate of recurrence varies significantly .
BACKGROUND	Therefore , new biomarkers are needed for better treatment and prognosis .
BACKGROUND	It has been shown that astrocyte elevated gene-1 ( AEG-1 ) is a key mediator of migration , invasion , and treatment resistance .
BACKGROUND	Our aim was to analyse the AEG-1 expression in relation to RT in rectal cancer patients and to test its radiosensitising properties .
METHODS	The AEG-1 expression was examined by immunohistochemistry in 158 patients from the Swedish clinical trial of RT. .
METHODS	Furthermore , we inhibited the AEG-1 expression by siRNA in five colon cancer cell lines and measured the survival after irradiation by colony-forming assay .
RESULTS	The AEG-1 expression was increased in the primary tumours compared with the normal mucosa independently of the RT ( P < 0.01 ) .
RESULTS	High AEG-1 expression in the primary tumour of the patients treated with RT correlated independently with higher risk of distant recurrence ( P = 0.009 ) and worse disease-free survival ( P = 0.007 ) .
RESULTS	Downregulation of AEG-1 revealed a decreased survival after radiation in radioresistant colon cancer cell lines .
CONCLUSIONS	The AEG-1 expression was independently related to distant recurrence and disease-free survival in rectal cancer patients with RT and could therefore be a marker to discriminate patients for distant relapse .

###24619189
OBJECTIVE	To evaluate the long-term effects of percutaneous tibial nerve stimulation ( PTNS ) on quality of life in women with chronic pelvic pain .
METHODS	Thirty-three women with chronic pelvic pain were randomized into PTNS ( n = 16 ) or control ( n = 17 ) groups .
METHODS	In PTNS group , weekly PTNS in 30-min sessions for 12 weeks was performed whereas the control group received no stimulation .
METHODS	Present pain intensity-visual analog scale ( PPI-VAS ) , short-form McGill pain questionnaire ( SF-MPQ ) , and SF-36 were used at baseline , 12-week , and 6-month follow-up for the evaluation of pain intensity and quality of life .
RESULTS	Two women ( 12.5 % ) were cured , 7 ( 43.8 % ) were much improved , 6 ( 37.5 % ) were the same and 1 ( 6.3 % ) was worse after PTNS .
RESULTS	Two women ( 11.8 % ) were improved , 10 ( 58.8 % ) were the same , and 5 ( 29.4 % ) were worse in the control group .
RESULTS	Mean PPI-VAS of PTNS group at baseline , 12 weeks , and 6 months was 8.4 1.1 , 3.8 3.5 and 4.5 3.7 , respectively .
RESULTS	There was a significant improvement in PPI-VAS scores of PTNS group whereas no change was observed in the control group .
RESULTS	There was a slight increase in the PPI-VAS scores of the PTNS group at 6-month , but the difference was not statistically significant .
RESULTS	There was significant improvement in all domains of SF-MPQ and SF-36 in PTNS group with continuing effects at 6 months whereas no significant change was observed in the control group .
CONCLUSIONS	PTNS is a minimally invasive treatment method that leads to decrease in pain severity and improvement in quality of life in women with chronic pelvic pain with effects continuing at 6 months .

###24881497
BACKGROUND	Antibiotics used to reduce nasal colonization by Staphylococcus aureus in patients before admission are inappropriate for carriage reduction on a regular basis within a hospital community .
BACKGROUND	Effective nonantibiotic alternatives for daily use in the nares will allow reduction of this bacterial source to be addressed .
METHODS	Our study tested the effectiveness of a nonantibiotic , alcohol-based antiseptic in reducing nasal bacterial carriage in health care professionals ( HCPs ) at an urban hospital center .
METHODS	HCPs testing positive for vestibular S aureus colonization were treated 3 times during the day with topical antiseptic or control preparations .
METHODS	Nasal S aureus and total bacterial colonization levels were determined before and at the end of a 10-hour workday .
RESULTS	Seventy-eight of 387 HCPs screened ( 20.2 % ) tested positive for S aureus infection .
RESULTS	Of 39 subjects who tested positive for S aureus infection who completed the study , 20 received antiseptic and 19 received placebo treatment .
RESULTS	Antiseptic treatment reduced S aureus colony forming units from baseline by 99 % ( median ) and 82 % ( mean ) ( P < .001 ) .
RESULTS	Total bacterial colony forming units were reduced by 91 % ( median ) and 71 % ( mean ) ( P < .001 ) .
CONCLUSIONS	Nasal application of a nonantibiotic , alcohol-based antiseptic was effective in reducing S aureus and total bacterial carriage , suggesting the usefulness of this approach as a safe , effective , and convenient alternative to antibiotic treatment .

###25407260
OBJECTIVE	The pharmacokinetics of nifedipine as a tocolytic agent has not been studied in great detail in pregnant women and has instead focused on immediate release tablets and gastrointestinal therapeutic system ( GITS ) tablets .
OBJECTIVE	The aim of this study was to determine nifedipine slow-release half-life and distribution volume in pregnant women and to compare these with pharmacokinetic parameters of nifedipine in non-pregnant subjects described in the literature .
METHODS	This is a study parallel to a trial studying women with threatened preterm labor between 26 + 0 and 32 + 2 weeks after initial tocolysis and a completed course of corticosteroids , who were randomly allocated to maintenance nifedipine ( slow-release tablets 20 mg 4 times daily ) or placebo .
METHODS	Exclusion criteria for the pharmacokinetic study were contra-indications for nifedipine , impaired liver function , and concomitant intake of inhibitors or inducers of the cytochrome P450 3A4 isoenzyme .
METHODS	Blood samples for measuring nifedipine plasma concentrations were drawn at t = 0 , t = 12 hours , t = 24 hours , t = 48 hours , t = 72 hours , t = 7 days , and t = 9 days .
METHODS	Pharmacokinetic parameters were estimated using iterative two-stage Bayesian population pharmacokinetic analysis by MWPharm software .
METHODS	The study was designed to establish a correlation between body weight and nifedipine plasma level .
RESULTS	The pharmacokinetic parameters of nifedipine slow-release tablets were determined from the data of 8 pregnant women .
RESULTS	Nifedipine slow-release had a half-life of 2 - 5 hours , a mean distribution volume of 6.2 1.9 L/kg ( calculated while using a fixed biological availability of 0.45 taken from the literature due to lack of intravenous data in this population ) compared to a half-life of 6 - 11 hours , and a distribution volume of 1.2 - 1.3 L/kg described in non-pregnant subjects in the literature .
RESULTS	None of the women delivered during study medication .
RESULTS	Study medication was continued for the duration of the pharmacokinetic study ( 9 days ) in all women .
RESULTS	A correlation between nifedipine plasma levels and maternal body weight was not demonstrated .
RESULTS	This may have been caused by lack of power .
CONCLUSIONS	Pregnant subjects in this study , using nifedipine slow-release tablets , showed a larger volume of distribution and a shorter elimination half-life than for non-pregnant subjects as published in the literature .

###24386489
BACKGROUND	Impairment of the mucosal barrier plays an important role in the pathophysiology of acute pancreatitis .
BACKGROUND	The myosin IXB ( MYO9B ) gene and the two tight-junction adaptor genes , PARD3 and MAGI2 , have been linked to gastrointestinal permeability .
BACKGROUND	Common variants of these genes are associated with celiac disease and inflammatory bowel disease , two other conditions in which intestinal permeability plays a role .
BACKGROUND	We investigated genetic variation in MYO9B , PARD3 and MAGI2 for association with acute pancreatitis .
METHODS	Five single nucleotide polymorphisms ( SNPs ) in MYO9B , two SNPs in PARD3 , and three SNPs in MAGI2 were studied in a Dutch cohort of 387 patients with acute pancreatitis and over 800 controls , and in a German cohort of 235 patients and 250 controls .
RESULTS	Association to MYO9B and PARD3 was observed in the Dutch cohort , but only one SNP in MYO9B and one in MAGI2 showed association in the German cohort ( p < 0.05 ) .
RESULTS	Joint analysis of the combined cohorts showed that , after correcting for multiple testing , only two SNPs in MYO9B remained associated ( rs7259292 , p = 0.0031 , odds ratio ( OR ) 1.94 , 95 % confidence interval ( 95 % CI ) 1.35-2 .78 ; rs1545620 , p = 0.0006 , OR 1.33 , 95 % CI 1.16-1 .53 ) .
RESULTS	SNP rs1545620 is a non-synonymous SNP previously suspected to impact on ulcerative colitis .
RESULTS	None of the SNPs showed association to disease severity or etiology .
CONCLUSIONS	Variants in MYO9B may be involved in acute pancreatitis , but we found no evidence for involvement of PARD3 or MAGI2 .

###24327037
OBJECTIVE	More than 70 % of patients with resistant hypertension have obstructive sleep apnea ( OSA ) .
OBJECTIVE	However , there is little evidence about the effect of continuous positive airway pressure ( CPAP ) treatment on blood pressure in patients with resistant hypertension .
OBJECTIVE	To assess the effect of CPAP treatment on blood pressure values and nocturnal blood pressure patterns in patients with resistant hypertension and OSA .
METHODS	Open-label , randomized , multicenter clinical trial of parallel groups with blinded end point design conducted in 24 teaching hospitals in Spain involving 194 patients with resistant hypertension and an apnea-hypopnea index ( AHI ) of 15 or higher .
METHODS	Data were collected from June 2009 to October 2011 .
METHODS	CPAP or no therapy while maintaining usual blood pressure control medication .
METHODS	The primary end point was the change in 24-hour mean blood pressure after 12 weeks .
METHODS	Secondary end points included changes in other blood pressure values and changes in nocturnal blood pressure patterns .
METHODS	Both intention-to-treat ( ITT ) and per-protocol analyses were performed .
RESULTS	A total of 194 patients were randomly assigned to receive CPAP ( n = 98 ) or no CPAP ( control ; n = 96 ) .
RESULTS	The mean AHI was 40.4 ( SD , 18.9 ) and an average of 3.8 antihypertensive drugs were taken per patient .
RESULTS	Baseline 24-hour mean blood pressure was 103.4 mm Hg ; systolic blood pressure ( SBP ) , 144.2 mm Hg ; and diastolic blood pressure ( DBP ) , 83 mm Hg .
RESULTS	At baseline , 25.8 % of patients displayed a dipper pattern ( a decrease of at least 10 % in the average nighttime blood pressure compared with the average daytime blood pressure ) .
RESULTS	The percentage of patients using CPAP for 4 or more hours per day was 72.4 % .
RESULTS	When the changes in blood pressure over the study period were compared between groups by ITT , the CPAP group achieved a greater decrease in 24-hour mean blood pressure ( 3.1 mm Hg [ 95 % CI , 0.6 to 5.6 ] ; P = .02 ) and 24-hour DBP ( 3.2 mm Hg [ 95 % CI , 1.0 to 5.4 ] ; P = .005 ) , but not in 24-hour SBP ( 3.1 mm Hg [ 95 % CI , -0.6 to 6.7 ] ; P = .10 ) compared with the control group .
RESULTS	Moreover , the percentage of patients displaying a nocturnal blood pressure dipper pattern at the 12-week follow-up was greater in the CPAP group than in the control group ( 35.9 % vs 21.6 % ; adjusted odds ratio [ OR ] , 2.4 [ 95 % CI , 1.2 to 5.1 ] ; P = .02 ) .
RESULTS	There was a significant positive correlation between hours of CPAP use and the decrease in 24-hour mean blood pressure ( r = 0.29 , P = .006 ) , SBP ( r = 0.25 ; P = .02 ) , and DBP ( r = 0.30 , P = .005 ) .
CONCLUSIONS	Among patients with OSA and resistant hypertension , CPAP treatment for 12 weeks compared with control resulted in a decrease in 24-hour mean and diastolic blood pressure and an improvement in the nocturnal blood pressure pattern .
CONCLUSIONS	Further research is warranted to assess longer-term health outcomes .
BACKGROUND	clinicaltrials.gov Identifier : NCT00616265 .

###24244295
BACKGROUND	Tools to predict death or spontaneous survival are necessary to inform liver transplantation ( LTx ) decisions in pediatric acute liver failure ( PALF ) , but such tools are not available .
BACKGROUND	Recent data suggest that immune/inflammatory dysregulation occurs in the setting of acute liver failure .
BACKGROUND	We hypothesized that specific , dynamic , and measurable patterns of immune/inflammatory dysregulation will correlate with outcomes in PALF .
METHODS	We assayed 26 inflammatory mediators on stored serum samples obtained from a convenience sample of 49 children in the PALF study group ( PALFSG ) collected within 7 days after enrollment .
METHODS	Outcomes were assessed within 21 days of enrollment consisting of spontaneous survivors , non-survivors , and LTx recipients .
METHODS	Data were subjected to statistical analysis , patient-specific Principal Component Analysis ( PCA ) , and Dynamic Bayesian Network ( DBN ) inference .
RESULTS	Raw inflammatory mediator levels assessed over time did not distinguish among PALF outcomes .
RESULTS	However , DBN analysis did reveal distinct interferon-gamma-related networks that distinguished spontaneous survivors from those who died .
RESULTS	The network identified in LTx patients pre-transplant was more like that seen in spontaneous survivors than in those who died , a finding supported by PCA .
CONCLUSIONS	The application of DBN analysis of inflammatory mediators in this small patient sample appears to differentiate survivors from non-survivors in PALF .
CONCLUSIONS	Patterns associated with LTx pre-transplant were more like those seen in spontaneous survivors than in those who died .
CONCLUSIONS	DBN-based analyses might lead to a better prediction of outcome in PALF , and could also have more general utility in other complex diseases with an inflammatory etiology .

###24892815
OBJECTIVE	Treatment of patients with prostate cancer has evolved considerably in the last decade , especially in terms of minimization of the negative impacts on erectile function and continence to ensure good quality of life for treated patients .
OBJECTIVE	New surgical devices , such as dissectors and hemostatic scalpels , allow precise definition of the surgical field with finer dissection of the anatomic structures , with subsequent reductions in operative times and better oncologic and functional outcomes .
OBJECTIVE	Although monopolar scissors ( MS ) are still widely used , radiofrequency ( RF ) and ultrasound ( US ) scalpels have been introduced recently in laparoscopic radical prostatectomy ( LRP ) .
OBJECTIVE	Despite the widespread use of these scalpels , however , few studies have compared these devices in terms of oncologic and functional outcomes after radical prostatectomy .
OBJECTIVE	The present study aimed to prospectively assess the impact of MS , RF , and US scalpels on margin status at apex , and recovery of urinary continence and erectile function in patients undergoing extraperitoneal LRP .
METHODS	A total of 150 men were prospectively enrolled between September 2009 and April 2013 and postoperatively evaluated for continence and clinical factors .
RESULTS	There were no differences in terms of operative times ( P = 0.9433 ) , blood loss ( P = 0.9681 ) , apical margin positivity ( P = 0.3965 ) or postoperative hospital stay ( P = 0.9257 ) among the groups .
RESULTS	Moreover , no differences in the functional outcome scores , as evaluated by the International Consultation on Incontinence self-administered Questionnaire , at 1 , 3 , and 6 months postsurgery were observed .
CONCLUSIONS	Our study represents the first evaluation of continence recovery in LRP with respect to different devices used for prostatic apex dissection .
CONCLUSIONS	We found that the oncologic , functional , and operative outcomes were similar between these different devices during LRP , with no scalpel demonstrating superiority in continence recovery .

###24633277
OBJECTIVE	This study was to determine any significant difference between the incidence of infectious morbidity with the use of a 24 hour antibiotics regimen compared to a 7-day course of antibiotics following elective caesarean section using a cheap and easily available combination of Ampicillin/Cloxacillin and Metronidazole .
METHODS	Two hundred patients planned to have elective caesarean section for various indications and who satisfied the inclusion criteria were enrolled in the study in two groups of 100 patients each between the period of January to June 2010 .
METHODS	Patients were randomized to receive either Ampiclox as 4 intravenous doses of 1g stat and 500 mg each 6 hourly and Metronidazole as 3 intravenous doses of 500 mg each 8 hourly both for 24 hours or same combination intravenously for 48 hours and subsequent oral use for 5 days .
RESULTS	The mean maternal age , parity , gestational age and indication for caesarean section were similar in the two groups of participants .
RESULTS	There was no statistical difference in the incidence of febrile morbidity ( 17 % / 18 % , p = 0.852 ) , urinary tract infection ( 6 % / 4 % , p = 0.196 ) , wound infection ( 4 % / 3 % , p = 0.056 ) and endometritis ( 3 % / 2 % , p = 0.367 ) .
RESULTS	The mean cost of antibiotics per patient ( N730 / $ 4.65 ) in the short term prophylaxis group was half that of the long term prophylaxis group ( N1 , 540 / $ 9.81 ) .
CONCLUSIONS	There was no difference in the incidence of infection related morbidity when short term prophylactic antibiotics was used at elective caesarean section compared to long term prophylactic antibiotics .

###25143506
BACKGROUND	Inferior scapular notching following reverse shoulder arthroplasty is due to mechanical impingement and , in some studies , has been associated with poorer functional scores , lower patient satisfaction , and more limited shoulder motion .
BACKGROUND	We aimed to test the hypothesis that inferior positioning of the center of rotation with eccentric glenosphere designs decreases the adduction deficit before impingement occurs and improves clinical outcome .
METHODS	A randomized , controlled , double-blinded trial was performed .
METHODS	According to the results of a power analysis , fifty patients undergoing reverse shoulder arthroplasty for the diagnosis of cuff tear arthropathy were randomized intraoperatively to receive either a concentric or eccentric glenosphere .
METHODS	The glenoid baseplate was positioned flush to the inferior border of the glenoid before the glenosphere was then attached .
METHODS	Notching was assessed using an anteroposterior radiograph , and clinical outcome was assessed using the visual analog pain scale score , shoulder function rating , American Shoulder and Elbow Surgeons score , and Oxford shoulder score .
METHODS	Active forward elevation and external rotation were assessed .
METHODS	The outcome assessor was blinded to the treatment group .
METHODS	The mean follow-up period for the groups was forty-three and forty-seven months .
RESULTS	Patient demographics and preoperative scores were similar between the groups .
RESULTS	At the time of the final follow-up , four patients ( 14.8 % ) in the concentric group had developed inferior scapular notching ( two with Nerot grade I and two with Nerot grade II ) , ranging in size from 1.1 to 7.4 mm , compared with one patient ( 4.3 % ; Nerot grade I ) in the eccentric group ( p = 0.36 ) .
RESULTS	No notching occurred in any patient with glenoid overhang of > 3.5 mm .
RESULTS	No significant difference between the groups was seen with respect to functional outcome scores , patient satisfaction , or shoulder motion .
CONCLUSIONS	There were no differences in notching rates or clinical outcomes between concentric and eccentric glenospheres following reverse shoulder arthroplasty .
CONCLUSIONS	Inferior glenosphere overhang of > 3.5 mm , however , prevented notching .
CONCLUSIONS	This may be achieved with a modified surgical technique , but eccentric glenospheres provide an additional option .
METHODS	Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence .

###24552199
BACKGROUND	Couples-based HIV counseling and testing ( CHCT ) is a proven strategy to reduce the risk of HIV transmission between partners , but uptake of CHCT is low .
BACKGROUND	We describe the study design of a randomized controlled trial ( RCT ) aimed to increase participation in CHCT and reduce sexual risk behavior for HIV among heterosexual couples in rural KwaZulu-Natal , South Africa .
BACKGROUND	We hypothesize that the rate of participation in CHCT will be higher and sexual risk behavior will be lower in the intervention group as compared to the control .
METHODS	Heterosexual couples ( N = 350 couples , 700 individuals ) are being recruited to participate in a randomized trial of a couples-based intervention comprising two group sessions ( one mixed gender , one single gender ) and four couples ' counseling sessions .
METHODS	Couples must have been in a relationship together for at least 6 months .
METHODS	Quantitative assessments are conducted via mobile phones by gender-matched interviewers at baseline , 3 , 6 , and 9 months post-randomization .
METHODS	Intervention content is aimed to improve relationship dynamics , and includes communication skills and setting goals regarding CHCT .
CONCLUSIONS	The Uthando Lwethu ( ` our love ' ) intervention is the first couples-based intervention to have CHCT as its outcome .
CONCLUSIONS	We are also targeting reductions in unprotected sex .
CONCLUSIONS	CHCT necessitates the testing and mutual disclosure of both partners , conditions that are essential for improving subsequent outcomes such as disclosure of HIV status , sexual risk reduction , and improving treatment outcomes .
CONCLUSIONS	Thus , improving rates of CHCT has the potential to improve health outcomes for heterosexual couples in a rural area of South Africa that is highly impacted by HIV .
CONCLUSIONS	The results of our ongoing clinical trial will provide much needed information regarding whether a relationship-focused approach is effective in increasing rates of participation in CHCT .
CONCLUSIONS	Our intervention represents an attempt to move away from individual-level conceptualizations , to a more integrated approach for HIV prevention .
BACKGROUND	Study Name : Couples in Context : An RCT of a Couples-based HIV Prevention InterventionClinicalTrials.gov identifier : NCT01953133.South African clinical trial registration number : DOH-27-0212-3937 .

###25388906
BACKGROUND	In this post-hoc analysis , we determined the influence of single nucleotide polymorphisms in host candidate immune genes on the outcome of drug resistant malaria in Cameroon .
METHODS	Human DNA from 760 patients from a previous clinical trial was subjected to mass spectrometry-based single nucleotide polymorphism ( SNP ) genotyping .
METHODS	Allele frequencies of candidate immune genes were calculated for 62 SNPs on 17 human chromosomes for their possible involvement in clearance of drug-resistant parasites with the triple mutations of pfcrt76T , pfmdr86Y , and pfmdr1246Y ( TY ) and pfdhfr51I , pfdhfr59R , pfdhfr108N , and pfdhps437G ( IRNG ) which were determined by dotblot or PCR-restriction analysis .
METHODS	Differences in SNP frequencies and association analysis were carried out by comparing Chi-square odds ratios ( ORs ) and stratified by Mantel-Haenzel statistics .
METHODS	An adjusted P value ( OR ) < 00008 was considered significant .
RESULTS	Post-treatment drug failure rates were amodiaquine ( 364 % ) ; sulpadoxine/pyrimethamine-amodiaquine combination ( 154 % ) ; and sulphadoxine/pyrimethamine ( 181 % ) .
RESULTS	SNPs in IL22 , IL-4R1 , and CD36 appeared to have been associated with clearance of resistant parasites [ p = 0017 , OR ( C allele ) :144 , 95 % CI ( OR ) : 106-195 ] ; [ P = 0014 , OR = 131 , 95 % CI ( OR ) : 107-183 ] ; [ P = 57810 ( -5 ) , OR = 027 , 95 % CI ( OR ) : 013-054 ] , respectively , with high fever ( > 39C for 48 hours ) [ IL-22 , P = 001 , OR = 15 , 95 % CI ( OR ) : 18-21 ] and also in high frequency among the Fulani participants [ P = 0006 , OR = 183 , 95 % CI ( OR ) : 111-308 ) ] .
RESULTS	The CD36-1264 null allele was completely absent in the northern population .
CONCLUSIONS	Independent association of SNPs in IL22 and IL-4 with clearance of amodiaquine - and sulphadoxine/pyrimethamine-resistant parasites did not reach statistical significance , but may suggest that not all drug-resistant mutants are adversely affected by the same immune-mediated mechanisms of clearance .

###24463933
OBJECTIVE	We validated the metabolic syndrome ( MetS ) score by confirmatory factor analysis ( CFA ) in children , middle-aged men , and older women and men and by investigating the relationships of the MetS score to incident type 2 diabetes , myocardial infarction , and cardiovascular and overall death in middle-aged men .
METHODS	We assessed the core features of MetS , calculated the MetS score using z scores for waist circumference , insulin , glucose , triacylglycerols , HDL-cholesterol and blood pressure , and carried out CFA to investigate whether MetS represents a single entity in population samples of 491 children , 1,900 middle-aged men , 614 older women and 555 older men from Finland .
METHODS	We also followed-up incident type 2 diabetes for 11 years and other outcomes for 17-18 years in middle-aged men .
RESULTS	We carried out second-order CFAs in which the MetS was represented by a second-order latent variable underlying four latent variables characterised by abdominal obesity , insulin resistance , dyslipidaemia and raised blood pressure in different age groups .
RESULTS	These second-order factors and factors derived from first-order CFA using previously proposed models were strongly associated with a composite MetS score in all age groups ( r = 0.84-0 .94 ) and similarly predicted type 2 diabetes , cardiovascular outcomes and mortality in middle-aged men .
RESULTS	The risk of type 2 diabetes , myocardial infarction , cardiovascular death and overall death increased 3.67 - , 1.38 - , 1.56 - and 1.44-fold , respectively , for a 1 SD increase in the MetS score .
CONCLUSIONS	The MetS can be described as a single entity in all age groups .
CONCLUSIONS	The MetS score is a valid tool for research evaluating cardiometabolic risk in different age groups .
CONCLUSIONS	Further research is needed to define cut-off points for risk estimation in clinical practice .

###24355490
BACKGROUND	Insufficient use of behavioral theory to understand health care workers ' ( HCWs ) hand hygiene compliance may result in suboptimal design of hand hygiene interventions and limit effectiveness .
BACKGROUND	Previous studies examined HCWs ' intended , rather than directly observed , compliance and/or focused on just 1 behavioral model .
BACKGROUND	This study examined HCWs ' explanations of noncompliance in `` real time '' ( immediately after observation ) , using a behavioral theory framework , to inform future intervention design .
METHODS	HCWs were directly observed and asked to explain episodes of noncompliance in `` real-time . ''
METHODS	Explanations were recorded , coded into 12 behavioral domains , using the Theory Domains Framework , and subdivided into themes .
RESULTS	Over two-thirds of 207 recorded explanations were explained by 2 domains .
RESULTS	These were `` Memory/Attention/Decision Making '' ( 87 , 44 % ) , subdivided into 3 themes ( memory , loss of concentration , and distraction by interruptions ) , and `` Knowledge '' ( 55 , 26 % ) , with 2 themes relating to specific hand hygiene indications .
RESULTS	No other domain accounted for more than 18 ( 9 % ) explanations .
CONCLUSIONS	An explanation of HCW 's `` real-time '' explanations for noncompliance identified `` Memory/Attention/Decision Making '' and `` Knowledge '' as the 2 behavioral domains commonly linked to noncompliance .
CONCLUSIONS	This suggests that hand hygiene interventions should target both automatic associative learning processes and conscious decision making , in addition to ensuring good knowledge .
CONCLUSIONS	A theoretical framework to investigate HCW 's `` real-time '' explanations of noncompliance provides a coherent way to design hand hygiene interventions .

###24875092
BACKGROUND	Western industrialised nations face a large increase in the number of older people .
BACKGROUND	People over the age of 60 years account for almost half of the 16.8 million hospital admissions in England from 2009 to 2010 .
BACKGROUND	During 2009-10 , respiratory infections accounted for approximately 1 in 30 hospital admissions and 1 in 20 of the 51.5 million bed-days .
OBJECTIVE	To determine the diagnostic accuracy and clinical effectiveness and cost-effectiveness of rapid molecular and near-patient diagnostic tests for influenza , respiratory syncytial virus ( RSV ) and Streptococcus pneumoniae infections in comparison with traditional laboratory culture .
METHODS	We carried out a randomised controlled trial ( RCT ) to evaluate impact on prescribing and clinical outcomes of point-of-care tests ( POCTs ) for influenza A and B and pneumococcal infection , reverse transcriptase-polymerase chain reaction ( RT-PCR ) tests for influenza A and B and RSV A and B , and conventional culture for these pathogens .
METHODS	We evaluated diagnostic accuracy of POCTs for influenza and pneumococcal infection , RT-PCR for influenza and sputum culture for S. pneumoniae using samples collected during the RCT .
METHODS	We did a systematic review and meta-analysis of POCTs for influenza A and B.
METHODS	We evaluated ease and speed of use of each test , process outcomes and cost-effectiveness .
RESULTS	There was no evidence of association between diagnostic group and prescribing or clinical outcomes .
RESULTS	Using PCR as ` gold standard ' , Quidel Influenza A+B POCT detected 24.4 % [ 95 % confidence interval ( CI ) 16.0 % to 34.6 % ] of influenza infections ( specificity 99.7 % , 95 % CI 99.2 % to 99.9 % ) ; viral culture detected 21.6 % ( 95 % CI 13.5 % to 31.6 % ; specificity 99.8 % , 95 % CI 99.4 % to 100 % ) .
RESULTS	Using blood culture as ` gold standard ' , BinaxNOW pneumococcal POCT detected 57.1 % ( 95 % CI 18.4 % to 90.1 % ) of pneumococcal infections ( specificity 92.5 % ; 95 % CI 90.6 % to 94.1 % ) ; sputum culture detected 100 % ( 95 % CI 2.5 % to 100 % ; specificity 97.2 % , 95 % CI 94.3 % to 98.9 % ) .
RESULTS	Overall , pooled estimates of sensitivity and specificity of POCTs for influenza from the literature were 74 % ( 95 % CI 67 % to 80 % ) and 99 % ( 95 % CI 98 % to 99 % ) , respectively .
RESULTS	Median intervals from specimen collection to test result were 15 minutes [ interquartile range ( IQR ) 10-23 minutes ) for Quidel Influenza A+B POCT , 20 minutes ( IQR 15-30 minutes ) for BinaxNOW pneumococcal POCT , 50.8 hours ( IQR 44.3-92 .6 hours ) for semi-nested conventional PCR , 29.2 hours ( IQR 26-46 .9 hours ) for real-time PCR , 629.6 hours ( IQR 262.5-846 .7 hours ) for culture of influenza and 84.4 hours ( IQR 70.7-137 .8 hours ) and 71.4 hours ( IQR 69.15-84 .0 hours ) for culture of S. pneumoniae in blood and sputum , respectively .
RESULTS	Both POCTs were rated straightforward and undemanding ; blood culture was moderately complex and all other tests were complex .
RESULTS	Costs and quality-adjusted life-years ( QALYs ) of each diagnostic strategy were similar .
RESULTS	Incrementally , PCR was most cost-effective ( 78.3 % probability at a willingness to pay of 20,000 / QALY ) .
RESULTS	Few patients were admitted within a timescale conducive to treatment with a neuraminidase inhibitor according to National Institute for Health and Care Excellence guidance .
CONCLUSIONS	The accuracy study was limited by inadequate gold standards .
CONCLUSIONS	All tests had limitations .
CONCLUSIONS	We found no evidence that POCTs for influenza or S. pneumoniae , or PCR for influenza or RSV influenced antimicrobial prescribing or clinical outcomes .
CONCLUSIONS	The total costs and QALYs of each diagnostic strategy were similar , although , incrementally , PCR was the most cost-effective strategy .
CONCLUSIONS	The analysis does not support routine use of POCTs for either influenza or pneumococcal antigen for adults presenting with acute cardiopulmonary conditions , but suggests that conventional viral culture for clinical diagnosis should be replaced by PCR .
BACKGROUND	Current Controlled Trials ISRCTN21521552 .
BACKGROUND	This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol .
BACKGROUND	18 , No. 36 .
BACKGROUND	See the NIHR Journals Library website for further project information .

###24346292
BACKGROUND	Elastic resistance bands ( ERB ) combined with proprioceptive neuromuscular facilitation ( PNF ) are often used in resistance muscle training programs , which have potential effects on peripheral muscle strength .
BACKGROUND	However , the effects of the combination of ERB and PNF on respiratory muscle strength warrant further investigation .
OBJECTIVE	The assessment of the effects of PNF combined with ERB on respiratory muscle strength .
METHODS	Twenty healthy , right-handed females were included .
METHODS	Subjects were randomized to either the resistance training program group ( TG , n = 10 ) or the control group ( CG , n = 10 ) .
METHODS	Maximal expiratory pressure ( MEP ) and inspiratory pressure ( MIP ) were measured before and after four weeks of an upper extremity resistance training program .
METHODS	The training protocol consisted of upper extremity PNF combined with ERB , with resistance selected from 1 repetition maximum protocol .
RESULTS	PNF combined with ERB showed significant increases in MIP and MEP ( p < 0.05 ) .
RESULTS	In addition , there were significant differences between the TG and CG regarding MIP ( p = 0.01 ) and MEP ( p = 0.04 ) .
CONCLUSIONS	PNF combined with ERB can have a positive impact on respiratory muscle strength .
CONCLUSIONS	These results may be useful with respect to cardiopulmonary chronic diseases that are associated with reduced respiratory muscle strength .

###24447606
OBJECTIVE	To examine the performance of T2-weighted ( T2W ) and diffusion-weighted ( DW ) magnetic resonance imaging ( MRI ) for detecting the index tumour in patients with prostate cancer and to examine the agreement between MRI and histology when assessing tumour volume ( TV ) and overall tumour burden .
METHODS	The study included 199 consecutive patients with biopsy confirmed prostate cancer randomised to MRI before radical prostatectomy from December 2009 to July 2012 .
METHODS	MRI-detected tumours ( MRTs ) were ranked from 1 to 3 according to decreasing volume and were compared with histologically detected tumours ( HTs ) ranked from 1 to 3 , with HT 1 = index tumour .
METHODS	Whole-mount section histology was used as a reference standard .
METHODS	The TVs of true-positive MRTs ( MRTVs 1-3 ) were compared with the TVs found by histology ( HTVs 1-3 ) .
METHODS	All tumours were registered on a 30-sector map and by classifying each sector as positive/negative , the rate of true-positive and - negative sectors was calculated .
RESULTS	The detection rate for the HT 1 ( index tumour ) was 92 % ; HT 2 , 45 % ; and HT 3 , 37 % .
RESULTS	The MRTV 1-3 vs the HTV 1-3 were 2.8 mL vs 4.0 mL ( index tumour , P < 0.001 ) , 1.0 mL vs 0.9 mL ( tumour 2 , P = 0.413 ) , and 0.6 mL vs 0.5 mL ( tumour 3 , P = 0.492 ) .
RESULTS	The rate of true-positive and - negative sectors was 50 % and 88 % , = 0.39 .
CONCLUSIONS	A combination of T2W and DW MRI detects the index tumour in 92 % of cases , although MRI underestimates both TV and tumour burden compared with histology .

###25098373
BACKGROUND	Heart rate variability ( HRV ) is a marker of autonomic dysfunction severity .
BACKGROUND	The effects of physical training on HRV indexes in Chagas heart disease ( CHD ) are not well established .
OBJECTIVE	To evaluate the changes in HRV indexes in response to physical training in CHD .
METHODS	Patients with CHD and left ventricular ( LV ) dysfunction , physically inactive , were randomized either to the intervention ( IG , N = 18 ) or control group ( CG , N = 19 ) .
METHODS	The IG participated in a 12-week exercise program consisting of 3 sessions/week .
RESULTS	Mean age was 49.5 8 years , 59 % males , mean LVEF was 36.3 7.8 % .
RESULTS	Baseline HRV indexes were similar between groups .
RESULTS	From baseline to follow-up , total power ( TP ) : 1653 ( IQ 625 - 3418 ) to 2794 ( 1617 - 4452 ) ms , p = 0.02 ) and very low frequency power : 586 ( 290 - 1565 ) to 815 ( 610 - 1425 ) ms , p = 0.047 ) increased in the IG , but not in the CG .
RESULTS	The delta ( post - pre ) HRV indexes were similar : SDNN 11.5 30.0 vs. 3.7 25.1 ms. p = 0.10 ; rMSSD 2 ( 6 - 17 ) vs. 1 ( 21 - 9 ) ms. p = 0.43 ; TP 943 ( 731 - 3130 ) vs. 1780 ( 921 - 2743 ) Hz .
RESULTS	p = 0.46 ; low frequency power ( LFP ) 1.0 ( 150 - 197 ) vs. 60 ( 111 - 146 ) Hz .
RESULTS	p = 0.85 ; except for high frequency power , which tended to increase in the IG : 42 ( 133 - 92 ) vs. 79 ( 61 - 328 ) Hz .
RESULTS	p = 0.08 ) .
CONCLUSIONS	In the studied population , the variation of HRV indexes was similar between the active and inactive groups .
CONCLUSIONS	Clinical improvement with physical activity seems to be independent from autonomic dysfunction markers in CHD .

###24350571
BACKGROUND	There is co-morbidity between parental depression and childhood conduct disorder .
BACKGROUND	The Incredible Years ( IY ) parenting programmes reduce both conduct disorder in children and depression in their parents .
BACKGROUND	Recent U.K. and Ireland trials of the effectiveness and cost-effectiveness of IY parenting programmes have assessed children 's health and social care service use , but little is known about the programme 's impact on parental service use .
BACKGROUND	This paper explores whether an above clinical cut-off score on the Beck Depression Inventory II ( BDI II ) is associated with high or low parental health and social care service use in high-risk families receiving the IY Basic Programme .
METHODS	This is a secondary analysis of a subsample ( N = 119 ) from the first U.K. community-based randomised controlled trial of the 12-week IY Basic Programme ( N = 153 ) .
METHODS	Parents with children at risk of developing conduct disorder were randomised to receive the programme or to a waiting-list control group .
METHODS	BDI II total and BDI II clinical depression cut-off scores were compared to frequencies and costs of parents ' service use , at baseline , six , twelve and eighteen months post-baseline for the intervention group and at baseline and six months post-baseline for the control group .
RESULTS	Intervention group parents who scored above the clinical cut-off on the BDI II at baseline used more health and social care services than those who scored below at baseline , six and eighteen months .
RESULTS	Significant reductions in service use frequencies were found for the intervention group only .
CONCLUSIONS	Parents with higher levels or depression used more health and social care service and parenting programmes have been shown to reduce parental depression and also health and social service use .
CONCLUSIONS	However , further exploration of depressed parents ' service use and the cost implications for publically funded health and social care services is needed .

###25344361
BACKGROUND	In the late 1990s , the use of high-dose chemotherapy ( HDCT ) and stem-cell rescue held promise for patients with advanced and poor prognosis germ-cell tumors ( GCT ) .
BACKGROUND	We started a randomized phase II trial to assess the efficacy of sequential HDCT compared with cisplatin , etoposide , and bleomycin ( PEB ) .
METHODS	Patients were randomly assigned to receive four cycles of PEB every 3 weeks or two cycles of PEB followed by a high-dose sequence ( HDS ) comprising HD-cyclophosphamide ( 7.0 g/m ( 2 ) ) , 2 courses of cisplatin and HD-etoposide ( 2.4 g/m ( 2 ) ) with stem-cell support , and a single course of HD-carboplatin [ area under the curve ( AUC ) 27 mg/ml min ] with autologous stem-cell transplant .
METHODS	Postchemotherapy surgery was planned on responding residual disease in both arms .
METHODS	The primary end point was progression-free survival ( PFS ) .
METHODS	The study was designed to detect a 30 % improvement of 5-year PFS ( from 40 % to 70 % ) , with 80 % power and two-sided at 5 % .
RESULTS	From December 1996 to March 2007 , 85 patients were randomized : 43 in PEB and 42 in HDS arm .
RESULTS	Median follow-up was 114.2 months [ interquartile range ( IQR ) : 87.7-165 .8 ] .
RESULTS	Complete or partial response with normal markers ( PRm - ) were obtained in 28 ( 65.1 % ) and 29 ( 69.1 % ) patients , respectively .
RESULTS	Five-year PFS was 55.8 % [ 95 % confidence interval ( CI ) 42.8-72 .8 ] and 54.8 % ( 95 % CI 41.6 % -72.1 % ) in PEB and HDS arm , respectively ( log-rank test P = 0.726 ) .
RESULTS	Five-year overall survival was 62.8 % ( 95 % CI 49.9-79 .0 ) and 59.3 % ( 95 % CI 46.1-76 .3 ) .
RESULTS	One toxic death ( PEB arm ) was recorded .
CONCLUSIONS	The study failed to meet the primary end point .
CONCLUSIONS	Furthermore , survival estimates of conventional-dose chemotherapy higher than expected should be accounted for and will likely limit further improvements in the first-line setting .
CONCLUSIONS	CLINICALTRIALS.GOV : NCT02161692 .

###24917648
BACKGROUND	Osteochondral lesions of the talus ( OLT ) frequently occur after ankle sprains in young patients participating in sports activities .
BACKGROUND	These injuries may lead to chronic pain , joint swelling , and finally osteoarthritis , therefore , surgical repair is frequently needed .
BACKGROUND	A collagen scaffold seeded with bone marrow-derived cells ( BMDCs ) harvested from patient 's iliac crest and implanted into the OLT through a single arthroscopic procedure has been recently proposed as an effective treatment option .
BACKGROUND	Nevertheless , BMDCs , embedded in an inflammatory environment , tend to differentiate toward a fibroblast phenotype with a consequential loss of mechanical characteristics .
BACKGROUND	Biophysical stimulation with pulsed electromagnetic fields ( PEMFs ) has been shown to promote anabolic chondrocyte activity , stimulate proteoglycan synthesis , and reduce the release of the most relevant pro-inflammatory cytokines .
BACKGROUND	The aim of this randomized controlled trial was to evaluate the effects of PEMFs on clinical outcome in patients who underwent BMDCs transplantation for OLT .
METHODS	Thirty patients affected by grade III and IV Outerbridge OLT underwent BMDCs transplantation .
METHODS	After surgery , patients were randomly assigned to either experimental group ( PEMFs 4 hours per day for 60 days starting within 3 days after operation ) or control group .
METHODS	Clinical outcome was evaluated with ( American Orthopaedic Foot and Ankle Society ) AOFAS score , Visual Analog Scale ( VAS ) , and Short Form-36 ( SF-36 ) .
RESULTS	Significantly higher AOFAS score was recorded in the experimental group both at 6 or 12 months follow-up .
RESULTS	At 60 days and 6 and 12 months follow-up , significant lower pain was observed in the experimental group .
RESULTS	No significant difference was found in SF-36 between groups .
CONCLUSIONS	A superior clinical outcome was found in the experimental group with more than 10 points higher AOFAS score at final follow-up .
CONCLUSIONS	Biophysical stimulation started soon after surgery aided patient recovery leading to pain control and a better clinical outcome with these improvements lasting more than 1 year after surgery .
METHODS	Level II , prospective comparative study .

###25348002
OBJECTIVE	Asparaginase is a critical agent used to treat acute lymphoblastic leukemia ( ALL ) .
OBJECTIVE	Pegaspargase ( SS-PEG ) , a pegylated form of Escherichia coli L-asparaginase with a succinimidyl succinate ( SS ) linker , is the first-line asparaginase product used in Children 's Oncology Group ( COG ) ALL trials .
OBJECTIVE	Calaspargase pegol ( SC-PEG ) replaces the SS linker in SS-PEG with a succinimidyl carbamate linker , creating a more stable molecule .
OBJECTIVE	COG AALL07P4 was designed to determine the pharmacokinetic and pharmacodynamic comparability of SC-PEG to SS-PEG in patients with newly diagnosed high-risk ( HR ) B-cell ALL .
METHODS	A total of 165 evaluable patients were randomly assigned at a 2:1 ratio to receive SC-PEG at 2,100 ( SC-PEG2100 ; n = 69 ) or 2,500 IU/m ( 2 ) ( SC-PEG2500 ; n = 42 ) versus SS-PEG 2,500 IU/m ( 2 ) ( SS-PEG2500 ; n = 54 ) as part of an otherwise identical chemotherapy regimen .
METHODS	The groups were similar demographically , except more female patients received SC-PEG2500 .
RESULTS	The mean half-life of plasma asparaginase activity for both SC-PEG doses was approximately 2.5 longer than that of SS-PEG2500 .
RESULTS	The total systemic exposure , as defined by induction area under the curve from time 0 to 25 days , was greater with SC-PEG2500 than with SS-PEG2500 or SC-PEG2100 .
RESULTS	The proportion of patients with plasma asparaginase activity 100 mIU/mL and 400 mIU/mL was higher in patients who received SC-PEG as compared with SS-PEG2500 .
RESULTS	After one dose of pegylated asparaginase on induction day 4 , plasma asparagine was undetectable for 11 days for SS-PEG2500 and 18 days for both SC-PEG groups .
CONCLUSIONS	SC-PEG2500 achieves a significantly longer period of asparaginase activity above defined thresholds and asparagine depletion compared with SS-PEG2500 and has a comparable toxicity profile in children with HR B-cell ALL .

###24509284
OBJECTIVE	The aim of this study was to confirm the cardioprotective effects of hypothermia using a combination of cold salineand endovascular cooling .
BACKGROUND	Hypothermia has been reported to reduce infarct size ( IS ) in patients with ST-segment elevation myocardial infarctions .
METHODS	In a multicenter study , 120 patients with ST-segment elevation myocardial infarctions ( < 6 h ) scheduled to undergopercutaneous coronary intervention were randomized to hypothermia induced by the rapid infusion of600to 2,000 ml cold saline and endovascular cooling or standard of care .
METHODS	Hypothermia was initiated before percutaneous coronary intervention and continued for 1 h after reperfusion .
METHODS	The primary end point was IS as apercent of myocardium at risk ( MaR ) , assessed by cardiac magnetic resonance imaging at 4 2 days .
RESULTS	Mean times from symptom onset to randomization were 129 56 min in patients receiving hypothermia and 132 64min in controls .
RESULTS	Patients randomized to hypothermia achieved a core body temperature of 34.7 C before reperfusion , with a 9-min longer door-to-balloon time .
RESULTS	Median IS/MaR was not significantly reduced ( hypothermia : 40.5 % [ interquartile range : 29.3 % to 57.8 % ; control : 46.6 % [ interquartile range : 37.8 % to 63.4 % ] ; relative reduction 13 % ; p = 0.15 ) .
RESULTS	The incidence of heart failure was lower with hypothermia at 45 15 days ( 3 % vs. 14 % , p < 0.05 ) , with no mortality .
RESULTS	Exploratory analysis of early anterior infarctions ( 0 to 4 h ) found a reduction in IS/MaR of 33 % ( p < 0.05 ) and an absolute reduction of IS/left ventricular volume of 6.2 % ( p = 0.15 ) .
CONCLUSIONS	Hypothermia induced by cold saline and endovascular cooling was feasible and safe , and it rapidly reduced coretemperature with minor reperfusion delay .
CONCLUSIONS	The primary end point of IS/MaR was not significantly reduced .
CONCLUSIONS	Lower incidence of heart failure and a possible effect in patients with early anterior ST-segment elevation myocardial infarctions need confirmation .
CONCLUSIONS	( Efficacy of Endovascular Catheter Cooling Combined With Cold Saline for the Treatment of Acute Myocardial Infarction [ CHILL-MI ] ; NCT01379261 ) .

###26034240
OBJECTIVE	Physicians have a major influence on parental vaccine decisions .
OBJECTIVE	We tested a physician-targeted communication intervention designed to ( 1 ) reduce vaccine hesitancy in mothers of infants seen by trained physicians and ( 2 ) increase physician confidence in communicating about vaccines .
METHODS	We conducted a community-based , clinic-level , 2-arm cluster randomized trial in Washington State .
METHODS	Intervention clinics received physician-targeted communications training .
METHODS	We enrolled mothers of healthy newborns from these clinics at the hospital of birth .
METHODS	Mothers and physicians were surveyed at baseline and 6 months .
METHODS	The primary outcome was maternal vaccine hesitancy measured by Parental Attitudes on Childhood Vaccines score ; secondary outcome was physician self-efficacy in communicating with parents by using 3 vaccine communication domains .
RESULTS	We enrolled 56 clinics and 347 mothers .
RESULTS	We conducted intervention trainings at 30 clinics , reaching 67 % of eligible physicians ; 26 clinics were randomized to the control group .
RESULTS	Maternal vaccine hesitancy at baseline and follow-up changed from 9.8 % to 7.5 % in the intervention group and 12.6 % to 8.0 % in the control group .
RESULTS	At baseline , groups were similar on all variables except maternal race and ethnicity .
RESULTS	The intervention had no detectable effect on maternal vaccine hesitancy ( adjusted odds ratio 1.22 , 95 % confidence interval 0.47-2 .68 ) .
RESULTS	At follow-up , physician self-efficacy in communicating with parents was not significantly different between intervention and control groups .
CONCLUSIONS	This physician-targeted communication intervention did not reduce maternal vaccine hesitancy or improve physician self-efficacy .
CONCLUSIONS	Research is needed to identify physician communication strategies effective at reducing parental vaccine hesitancy in the primary care setting .

###24309616
BACKGROUND	Physical therapy influences chronic pain by means of the specific ingredient of an intervention as well as contextual factors including the setting and therapeutic alliance ( TA ) between provider and patient .
OBJECTIVE	The purpose of this study was to compare the effect of enhanced versus limited TA on pain intensity and muscle pain sensitivity in patients with chronic low back pain ( CLBP ) receiving either active or sham interferential current therapy ( IFC ) .
METHODS	An experimental controlled study with repeated measures was conducted .
METHODS	Participants were randomly divided into 4 groups : ( 1 ) AL ( n = 30 ) , which included the application of active IFC combined with a limited TA ; ( 2 ) SL ( n = 29 ) , which received sham IFC combined with a limited TA ; ( 3 ) AE ( n = 29 ) , which received active IFC combined with an enhanced TA ; and ( 4 ) SE ( n = 29 ) , which received sham IFC combined with an enhanced TA .
METHODS	One hundred seventeen individuals with CLBP received a single session of active or sham IFC .
METHODS	Measurements included pain intensity as assessed with a numerical rating scale ( PI-NRS ) and muscle pain sensitivity as assessed via pressure pain threshold ( PPT ) .
RESULTS	Mean differences on the PI-NRS were 1.83 cm ( 95 % CI = 14.3-20 .3 ) , 1.03 cm ( 95 % CI = 6.6-12 .7 ) , 3.13 cm ( 95 % CI = 27.2-33 .3 ) , and 2.22 cm ( 95 % CI = 18.9-25 .0 ) for the AL , SL , AE , and SE groups , respectively .
RESULTS	Mean differences on PPTs were 1.2 kg ( 95 % CI = 0.7-1 .6 ) , 0.3 kg ( 95 % CI = 0.2-0 .8 ) , 2.0 kg ( 95 % CI = 1.6-2 .5 ) , and 1.7 kg ( 95 % CI = 1.3-2 .1 ) , for the AL , SL , AE , and SE groups , respectively .
CONCLUSIONS	The study protocol aimed to test the immediate effect of the TA within a clinical laboratory setting .
CONCLUSIONS	The context in which physical therapy interventions are offered has the potential to dramatically improve therapeutic effects .
CONCLUSIONS	Enhanced TA combined with active IFC appears to lead to clinically meaningful improvements in outcomes when treating patients with CLBP .

###24560278
BACKGROUND	Statins have multiple antiatherosclerotic effects , but can reduce blood plasma concentrations of minerals , including zinc .
BACKGROUND	As zinc possesses antiinflammatory and antioxidant effects , low zinc status can promote injuries or inadequate tissue repair in endothelial cells .
BACKGROUND	Metallothionein ( MT ) expression might modulate responses induced by statins in patients with atherosclerosis .
BACKGROUND	However , research regarding mineral status and the use of statins is scarce .
BACKGROUND	This study evaluated the effects of zinc supplementation on zinc status and expression of the zinc-dependent MT1F and MT2A genes in patients with atherosclerosis treated with rosuvastatin .
METHODS	A double-blind , randomized clinical trial was performed with 54 participants treated with 10mg rosuvastatin for 4 months with or without zinc supplementation ( 30mg/day ) .
METHODS	Diet , lipid profile , high-sensitivity reactive protein C ( hs-CRP ) , plasma and erythrocyte zinc concentrations , erythrocyte superoxide dismutase ( SOD ) activity , and MT1F and MT2A genes expression were analyzed before and after intervention .
RESULTS	Rosuvastatin therapy was effective in reducing low - and non-high-density lipoprotein , total cholesterol , triglycerides , and hs-CRP levels , independent of zinc supplementation .
RESULTS	Additionally , zinc treatment had no effect on SOD enzyme activity ( P = 0.201 ) , plasma ( P > 0.671 ) and erythrocyte ( P > 0.123 ) zinc concentrations , or the pattern of MT1F and MT2A genes expression ( P = 0.088 and P = 0.229 , respectively ) .
CONCLUSIONS	The effectiveness of rosuvastatin treatment is independent of the effects of zinc supplementation .
CONCLUSIONS	Moreover , rosuvastatin treatment did not have a significant impact on zinc status or MT1F and MT2A genes expression in patients with atherosclerosis .

###25688495
OBJECTIVE	A reduction of gynaecological adverse events has been reported in trials comparing aromatase inhibitors with tamoxifen as adjuvant treatment in postmenopausal women with early breast cancer , but there is a paucity of randomised studies specifically investigating their effects on the uterus .
OBJECTIVE	We report here the results of a prospective phase III trial comparing the effects of tamoxifen and exemestane by transvaginal ultrasound ( TVUS ) .
METHODS	Postmenopausal patients with ER + early breast cancer were randomised to receive tamoxifen 20 mg once daily or exemestane 25 mg once daily as adjuvant hormone therapy .
METHODS	TVUS was performed at baseline and at 6 and 12 months to measure endometrial thickness ( ET ) and uterine volume ( UV ) .
RESULTS	A total of 123 women were randomised to tamoxifen ( n = 61 ) or exemestane ( n = 62 ) .
RESULTS	A significantly higher proportion of patients in the tamoxifen group had increased ET at 6 and 12 months from randomisation compared with the exemestane group ( 66.1 % and 64.3 % versus 12.1 % and 6.8 % , respectively ; P < 0.0001 ) .
RESULTS	Mean ET and UV also significantly increased with tamoxifen compared to exemestane at both time points ( P < 0.01 for all comparisons ) .
CONCLUSIONS	Tamoxifen is associated with endometrial thickening and increased uterine volume in a significant proportion of postmenopausal women with early breast cancer .
CONCLUSIONS	Our study confirms the lack of endometrial effects of exemestane , which may be of interest to patients and clinicians when choosing among adjuvant endocrine options for breast cancer .

###25170230
OBJECTIVE	To evaluate the efficacy of furazolidone-based triple and quadruple therapy in eradicating Helicobacter pylori ( H. pylori ) in a multi-center randomized controlled trial .
METHODS	A total of 720 H. pylori positive patients with duodenal ulcer disease were enrolled at 10 different hospitals in Jiangxi province in China .
METHODS	The patients were randomly assigned to four treatment groups as follows : patients in Groups 1 and 3 received rabeprazole ( 10 mg ) , amoxicillin ( 1000 mg ) and furazolidone ( 100 mg ) twice daily for 7 and 10 d , respectively ; patients in Groups 2 and 4 received rabeprazole ( 10 mg ) , bismuth ( 220 mg ) , amoxicillin ( 1000 mg ) and furazolidone ( 100 mg ) twice daily for 7 and 10 d , respectively .
METHODS	The primary outcome measure was H. pylori eradication rate 4 wk after treatment by intention-to-treat and per protocol analysis , while the secondary outcome measures were symptom and sign changes at the end of treatment and 4 wk after the end of treatment , as well as the proportion of patients who developed adverse events .
RESULTS	The demographic data of the four groups were not significantly different .
RESULTS	Overall , 666 patients completed the scheme and were re-assessed with the ( 13 ) C-urea breath test .
RESULTS	The intention-to-treat analysis of the H. pylori eradication rates in Groups 1 , 2 , 3 and 4 were 74.44 % , 82.78 % , 78.89 % and 86.11 % , respectively .
RESULTS	The H. pylori eradication rate in Group 4 was significantly higher than that in Group 1 .
RESULTS	According to the per protocol analysis , the H. pylori eradication rates in Groups 1 , 2 , 3 and 4 were 81.21 % , 89.22 % , 85.54 % and 92.26 % , respectively .
RESULTS	The H. pylori eradication rate in Group 4 was significantly higher than that in Group 1 .
RESULTS	The number of adverse events was 15 ( 8.3 % ) , 16 ( 8.9 % ) , 15 ( 8.3 % ) and 17 ( 9.4 % ) in Groups 1 , 2 , 3 and 4 , respectively , including dizziness , vomiting , diarrhea , nausea , skin rash , itchy skin , and malaise .
RESULTS	The symptoms were relieved without special treatment in all of the patients .
CONCLUSIONS	Both 7 - and 10-d quadruple furazolidone-based therapies achieve satisfactory H. pylori eradication rates .

###25354950
BACKGROUND	Heart failure with preserved left ventricular ejection fraction ( HFpEF ) currently affects more than seven million Europeans and is the only cardiovascular disease increasing in prevalence and incidence .
BACKGROUND	No pharmacological agent has yet been shown to improve symptoms or prognosis .
BACKGROUND	The most promising way to improve pathophysiology and deprived exercise-tolerance in HFpEF patients seems to be exercise training , but the optimal approach and dose of exercise is still unknown .
OBJECTIVE	The major objective of the optimising exercise training in prevention and treatment of diastolic heart failure study ( OptimEx-CLIN ) is to define the optimal dose of exercise training in patients with HFpEF .
OBJECTIVE	In order to optimise adherence , supervision and economic aspects of exercise training a novel telemedical approach will be introduced and investigated .
METHODS	In a prospective randomised multi-centre study , 180 patients with stable symptomatic HFpEF will be randomised ( 1:1:1 ) to moderate intensity continuous training , high intensity interval training , or a control group .
METHODS	The training intervention includes three months supervised followed by nine months of telemedically monitored home-based training .
METHODS	The primary endpoint is change in exercise capacity , defined as change in peak oxygen uptake ( VO2peak ) after three months , assessed by cardiopulmonary exercise testing .
METHODS	Secondary endpoints include diastolic filling pressure ( E/e ' ) and further echocardiographic and cardiopulmonary exercise testing ( CPX ) parameters , biomarkers , quality of life and endothelial function .
METHODS	Training sessions and physical activity will be monitored and documented throughout the study with accelerometers and heart rate monitors developed on a telemedical platform for the OptimEx-CLIN study .
METHODS	Inclusion of patients started in July 2014 , first results are expected in 2017 .

###25438272
OBJECTIVE	The authors hypothesized that a muscle relaxant would have no meaningful difference in intubation conditions during nasal intubation under remifentanil and propofol anesthesia .
METHODS	This parallel-group , double-blinded , randomized controlled trial included 44 patients who received saline ( S group ; n = 22 ) or rocuronium ( R group ; n = 22 ) .
METHODS	In addition to remifentanil 0.5 g/kg per minute and propofol 5 mg/kg per hour , propofol 0.5 mg/kg was administered until loss of consciousness .
METHODS	Nasal intubation was performed 10 minutes after administration of R or S 0.6 mg/kg .
METHODS	Significant differences in intubation conditions and salivary amylase levels before and after intubation were tested ( P < .05 ) .
RESULTS	Vocal cord status ( P = .003 ) and response to intubation or cuff filling ( P = .008 ) were significantly different , but intubation conditions were not .
RESULTS	Salivary amylase level was significantly lower with R administration ( P = .022 ) .
RESULTS	No patient complained of postoperative throat pain and hoarseness .
CONCLUSIONS	Muscle relaxants during nasal intubation performed after bolus administration of propofol 0.9 mg/kg in addition to 10 minutes of remifentanil 0.5 g/kg per minute plus propofol 5 mg/kg per hour are unnecessary .

###24899662
OBJECTIVE	The aims of this study were to establish whether , in patients with gout , MPO is released from neutrophils and urate is oxidized to allantoin and if these effects are attenuated by allopurinol .
METHODS	MPO , urate , allantoin and oxypurinol were measured in plasma from 54 patients with gout and 27 healthy controls .
METHODS	Twenty-three patients had acute gout , 13 of whom were receiving allopurinol , and 31 had intercritical gout , 20 of whom were receiving allopurinol .
METHODS	Ten additional gout patients had samples collected before and after 4 weeks of allopurinol .
RESULTS	Plasma MPO and its specific activity were higher ( P < 0.05 ) in patients with acute gout not receiving allopurinol compared with controls .
RESULTS	MPO protein in patients ' plasma was related to urate concentration ( r = 0.5 , P < 0.001 ) .
RESULTS	Plasma allantoin was higher ( P < 0.001 ) in all patient groups compared with controls .
RESULTS	In controls and patients not receiving allopurinol , allantoin was associated with plasma urate ( r = 0.62 , P < 0.001 ) and MPO activity ( r = 0.45 , P < 0.002 ) .
RESULTS	When 10 patients were treated with allopurinol , it lowered their plasma urate and allantoin ( P = 0.002 ) .
RESULTS	In all patients receiving allopurinol , plasma allantoin was related to oxypurinol ( r = 0.65 , P < 0.0001 ) .
RESULTS	Oxypurinol was a substrate for purified MPO that enhanced the oxidation of urate .
CONCLUSIONS	Increased concentrations of urate in gout lead to the release of MPO from neutrophils and the oxidation of urate .
CONCLUSIONS	Products of MPO and reactive metabolites of urate may contribute to the pathology of gout and hyperuricaemia .
CONCLUSIONS	At low concentrations , oxypurinol should reduce inflammation , but high concentrations may contribute to oxidative stress .

###24844229
OBJECTIVE	To propose a simple correction of body-mass index ( BMI ) based on self-reported weight and height ( reported BMI ) using gender , body shape perception and socioeconomic status in an adolescent population .
METHODS	341 boys and girls aged 17-18 years were randomly selected from a representative sample of 2165 French adolescents living in Paris surveyed in 2010 .
METHODS	After an anonymous self-administered pen-and-paper questionnaire asking for height , weight , body shape perception ( feeling too thin , about the right weight or too fat ) and socioeconomic status , subjects were measured and weighed .
METHODS	BMI categories were computed according to Cole 's cut-offs .
METHODS	Reported BMIs were corrected using linear regressions and ROC analyses and checked with cross-validation and multiple imputations to handle missing values .
METHODS	Agreement between actual and corrected BMI values was estimated with Kappa indexes and Intraclass correlation coefficients ( ICC ) .
RESULTS	On average , BMIs were underreported , especially among girls .
RESULTS	Kappa indexes between actual and reported BMI were low , especially for girls : 0.56 95 % CI = [ 0.42-0 .70 ] for boys and 0.45 95 % CI = [ 0.30-0 .60 ] for girls .
RESULTS	The regression of reported BMI by gender and body shape perception gave the most balanced results for both genders : the Kappa and ICC obtained were 0.63 95 % CI = [ 0.50-0 .76 ] and 0.67 , 95 % CI = [ 0.58-0 .74 ] for boys ; 0.65 95 % CI = [ 0.52-0 .78 ] and 0.74 , 95 % CI = [ 0.66-0 .81 ] for girls .
RESULTS	The regression of reported BMI by gender and socioeconomic status led to similar corrections while the ROC analyses were inaccurate .
CONCLUSIONS	Using body shape perception , or socioeconomic status and gender is a promising way of correcting BMI in self-administered questionnaires , especially for girls .

###25592742
BACKGROUND	Souvenaid is a nutraceutical compound thought to positively enhance synaptic function .
BACKGROUND	In line with this mechanism of action , Souvenaid has been shown to improve cognitive function in subjects with mild Alzheimer 's disease in randomized clinical trials .
BACKGROUND	To date , however , the potential of Souvenaid to improve cognitive functioning in subjects with other neurodegenerative conditions also characterized by synaptic loss has not been explored .
OBJECTIVE	To evaluate the impact of Souvenaid on executive functions , social cognition and behavioral disturbances in subjects with the behavioral variant of frontotemporal dementia ( bv-FTD ) .
METHODS	Twenty-six subjects with bv-FTD were enrolled in the study and randomized to Souvenaid ( 125 ml/day ) or placebo groups .
METHODS	After 12 weeks , subjects were switched between the two groups .
METHODS	All subjects , blinded to treatment , underwent clinical and cognitive evaluations at enrollment , after 12 weeks and after 24 weeks .
RESULTS	Treatment with Souvenaid was associated with a significant reduction of behavioral symptoms and an increase in Theory of Mind skills compared to placebo , which both returned to baseline when Souvenaid was discontinued .
RESULTS	Souvenaid did not have an effect on executive functions .
CONCLUSIONS	Our results provide evidence of the potential of Souvenaid therapy for the treatment of behavioral disturbances and social cognition skills in FTD .

###24650002
BACKGROUND	Intracranial-pressure ( ICP ) monitoring is considered standard care for severe traumatic brain injury and is used frequently , but the efficacy of treatment based on monitoring in patients with hemorrhagic stroke has not been rigorously assessed .
BACKGROUND	In this study , we investigated the clinical value of ICP monitoring in patients with hemorrhagic stroke .
METHODS	We conducted a randomized , unblinded , controlled trial in which 90 patients with hemorrhagic stroke were randomly assigned to ICP monitoring or a control group .
METHODS	The primary outcome was a composite of incidence rate of hematoma enlargement and secondary brain herniation .
METHODS	The secondary outcome was neurological status assessed using the Glasgow Outcome Scale scores at 6months post-onset .
METHODS	Characteristics of the patients at baseline and outcome measurements were also compared between the two groups .
RESULTS	There was no significant between-group difference in the incidence of hematoma enlargement ( control group , 38.6 % vs. ICP monitoring group , 32.6 % ; P > 0.05 ) .
RESULTS	The incidence rate of secondary brain herniation in the ICP monitoring group was significantly lower compared with the control group ( 10.9 % vs. 20.5 % , P = 0.04 ) .
RESULTS	Six-month mortality was 6.5 % in the ICP group and 9.1 % in the control group ( P < 0.05 ) , and neurological outcome was better in the ICP group compared with the control group ( P < 0.05 ) .
CONCLUSIONS	The dynamic ICP value may be more sensitive and effective in preventing secondary brain herniation in patients with hemorrhagic stroke compared with guidance directed by clinical signs and radiological indicators .

###24479361
OBJECTIVE	To explore the pain control effect of lornoxicam on patients after nasal packing .
METHODS	A total of 56 patients undergoing nasal packing between January 2011 and August 2011 were randomly divided into the treatment group and control group .
METHODS	( 1 ) Treatment group : routinely given lornoxicam for injection 8 mg ( 2 ml ) , intravenous injection , twice a day ; ( 2 ) CONTROL GROUP : given saline 2 ml , intravenous injection , twice a day , other treatments are the same with the treatment group .
METHODS	Visual analog scale was used to record the painful severity of nose and head at 3 , 6 , 12 , 24 and 48 h , and record the sleep quality score at 24 and 48 h.
RESULTS	The pain in nose and head and night sleeping in treatment group were all significantly better than that in control group .
CONCLUSIONS	The analgesic effect of lornoxicam in nasal packing is good , with no evident adverse reactions .

###25427033
OBJECTIVE	Noninvasive brain stimulation , including repetitive transcranial magnetic stimulation ( rTMS ) and transcranial direct current stimulation ( tDCS ) , have gained popularity in the stroke rehabilitation literature .
OBJECTIVE	Little is known about the time course and duration of effects of noninvasive brain stimulation on corticospinal excitability in individuals with stroke .
OBJECTIVE	We examined the aftereffects of a single session of high-frequency rTMS ( 5 Hz ) and anodal tDCS on corticospinal excitability in the same sample of participants with chronic stroke .
METHODS	Ten individuals with chronic stroke participated in this randomized cross-over study .
METHODS	Participants received 1 session of rTMS and 1 session of tDCS , with 1 week between sessions .
METHODS	During the rTMS session , 5-Hz rTMS ( total of 1200 stimuli ) was administered to the ipsilesional primary motor cortex ( M1 ) .
METHODS	For anodal tDCS , 1 mA of direct current was delivered to the ipsilesional M1 for 20 minutes .
METHODS	Motor evoked potentials were measured before and after ( immediately , 15 minutes , 30 minutes , and 60 minutes ) each stimulation session .
RESULTS	Both 5-Hz rTMS and anodal tDCS significantly increased corticospinal excitability for 30 to 60 minutes after stimulation .
RESULTS	There was no statistically significant difference between the 2 stimulation techniques in their effects on motor evoked potentials .
RESULTS	No changes in measures of motor or cognitive performance were observed .
CONCLUSIONS	Both 5-Hz rTMS and anodal tDCS induced effects on corticospinal excitability in persons with chronic stroke lasting at least 1 hour after stimulation .
CONCLUSIONS	In the absence of concurrent motor practice , neither form of stimulation applied in a single session was associated the changes in motor performance .
CONCLUSIONS	These approaches to increased cortical excitability may be of value as adjuncts to training .
BACKGROUND	See Video ( Supplemental Digital Content 1 , http://links.lww.com/JNPT/A83 ) for more insights from the authors .

###25305230
BACKGROUND	Postoperative infection after breast reduction surgery is a common complication , with the most commonly involved pathogen being Staphylococcus aureus .
BACKGROUND	Previous studies of antibiotic prophylaxis in breast reduction surgery have been inconclusive .
BACKGROUND	The aim of the present study was to clarify the role of prophylactic antibiotics in breast reduction surgery .
METHODS	In total , 325 women were randomized to antibiotic prophylaxis [ with 2 g of cloxacillin intravenously ( IV ) or 600 mg of clindamycin IV ] ( intervention group ) or no antibiotic prophylaxis ( control group ) .
METHODS	Follow-up was conducted at 1 and 2 weeks postoperatively .
METHODS	Patients with signs of infections or other complications were followed up until resolution .
METHODS	Patients who received antibiotic treatment within 30 days from surgery ( cloxacillin 750 mg or clindamycin 300 mg orally ) were considered having an infection and this was the main outcome variable .
METHODS	All postoperative infections were also judged according to a graded scale .
RESULTS	In the intervention group , 26 ( 16.0 % ) patients were treated with antibiotic ; and in the control group , 32 ( 19.6 % ) patients were treated with antibiotics .
RESULTS	No difference was found between the groups ( relative risk , 0.82 ; 95 % confidence interval , 0.51-1 .31 ; P = 0.49 ) .
RESULTS	Twenty-two ( 14 % ) patients in the intervention group were classified to have a possible infection according to the scale compared to 27 ( 17 % ) in the control group .
RESULTS	No statistical difference was found ( relative risk , 0.81 ; 95 % confidence interval , 0.48-1 .37 ; P = 0.54 ) .
CONCLUSIONS	Prophylactic cloxacillin as a single-dose IV in breast reduction surgery does not reduce the incidence of postoperative infections .

###25253199
BACKGROUND	Personalized medicine is the holy grail of medicine .
BACKGROUND	The EULAR recommendations for the management of rheumatoid arthritis ( RA ) support differential treatment between patients with baseline characteristics suggestive of a non-poor prognosis ( non-PP ) or poor prognosis ( PP ) ( presence of autoantibodies , a high inflammatory activity and damage on radiographs ) .
BACKGROUND	We aimed to determine which prognostic risk groups benefit more from initial monotherapy or initial combination therapy .
METHODS	508 patients were randomized to initial monotherapy ( iMono ) or initial combination therapy ( iCombo ) .
METHODS	Disease outcomes of iMono and iCombo were compared within non-PP or PP groups as determined on baseline characteristics
RESULTS	PP patients treated with iCombo after three months more often achieved ACR20 ( 70 % vs 38 % , P < 0.001 ) , ACR50 ( 48 % vs 13 % , P < 0.001 ) and ACR70 response ( 24 % vs 4 % , P < 0.001 ) than those treated with iMono , and had more improvement in HAQ ( median decrease 0.75 vs 0.38 , P < 0.001 ) .
RESULTS	After 1 year , differences in ACR20 response and DAS-remission remained ; PP patients treated with iCombo ( vs iMono ) had less radiographic progression ( median 0.0 vs 1.5 , P = 0.001 ) .
CONCLUSIONS	Since PP and non-PP patients benefit equally from iCombo through earlier clinical response and functional improvement than with iMono , we conclude that personalized medicine as suggested in the guidelines is not yet feasible .
CONCLUSIONS	The choice of treatment strategy should depend more on rapid relief of symptoms than on prognostic factors .
BACKGROUND	Netherlands Trial Register NTR262 ( registered 7 September 2005 ) and NTR265 ( 8 September 2005 ) .

###24519622
OBJECTIVE	The aim of this study was to evaluate the effect of knee position during wound closure ( flexed vs. extended ) in total knee arthroplasty on knee strength and function , as determined by knee society scores and isokinetic testing of extensor and flexor muscle groups .
METHODS	In a prospective , randomized , double-blind trial , 29 patients were divided in two groups : for Group 1 patients , surgical closing was performed with the knee extended , and for Group 2 patients , the knee flexed at 90 .
METHODS	All the patients were treated with the same anaesthesia method , surgical team , surgical technique , prosthesis type , and rehabilitation process .
METHODS	American Knee Society Score values and knee flexion degrees were recorded .
METHODS	Isokinetic muscle strength measurements of both knees in flexion and extension were taken using 60 and 180/s angular velocity .
METHODS	The peak torque and total work values , isokinetic muscle strength differences , and total work difference values were calculated for surgically repaired and healthy knees .
RESULTS	No significant difference in the mean American Knee Society Score values and knee flexion degrees was observed between the two groups .
RESULTS	However , using isokinetic evaluation , a significant difference was found in the isokinetic muscle strength differences and total work difference of the flexor muscle between the two groups when patients were tested at 180/s .
RESULTS	Less loss of strength was detected in the isokinetic muscle strength differences of the flexor muscle in Group 2 ( -4.2 % ) than in Group 1 ( -23.1 % ) .
CONCLUSIONS	For patients undergoing total knee arthroplasty , post-operative flexor muscle strength is improved if the knee is flexed during wound closure .
METHODS	II .

###25124362
OBJECTIVE	Patients with diabetes mellitus inject insulin in different regions of the body .
OBJECTIVE	This study investigated the pharmacokinetic and pharmacodynamic properties of insulin degludec ( IDeg ) , a new-generation once-daily basal insulin with an ultra-long duration of action , after subcutaneous ( SC ) administration in different injection regions .
METHODS	In this study , 20 healthy subjects received single SC doses of IDeg ( 0.4 U/kg ; separated by 13-21days ) in the thigh , abdomen and deltoid in a randomised , open-label , single-centre , single-dose , complete crossover trial .
METHODS	Each dose was followed by a 24-h euglycaemic clamp and 120-h pharmacokinetic blood sampling .
METHODS	The obtained pharmacokinetic/pharmacodynamic profiles were extrapolated to steady state by simulation using a pharmacokinetic/pharmacodynamic model .
RESULTS	Total IDeg exposure [ area under the IDeg serum concentration-time curve 0-120h after a single dose ( AUCIDeg,0-120h , SD ) ] and maximum serum concentration [ maximum IDeg serum concentration after a single dose ( C max , IDeg , SD ) ] were higher ( 6-7 and 23-27 % , respectively ) following a single SC dose in the deltoid or abdomen , compared with the thigh , as also observed with other insulin preparations .
RESULTS	No statistical difference was observed in these measures between deltoid and abdominal administration .
RESULTS	No pronounced differences were observed in the glucose-lowering effect of IDeg [ area under the glucose infusion rate ( GIR ) curve 0-24h after a single dose ( AUCGIR,0-24h , SD ) and maximum GIR after a single dose ( GIRmax , SD ) ] when injected in the thigh , abdomen or deltoid ( AUCGIR,0-24h , SD 2,572 , 2,833 and 2,960 mg/kg , respectively ) .
RESULTS	Simulated mean steady-state pharmacokinetic and pharmacodynamic profiles supported a flat and stable IDeg exposure and effect regardless of injection region , with comparable total glucose-lowering effects [ area under the GIR curve at steady state ( AUCGIR , , SS ) ] between the thigh , abdomen and deltoid .
CONCLUSIONS	These findings support administering IDeg SC in the thigh , upper arm or abdominal wall without affecting IDeg absorption or effect at steady state .

###25856121
BACKGROUND	FVC outcomes in clinical trials on idiopathic pulmonary fibrosis ( IPF ) can be substantially influenced by the analytic methodology and the handling of missing data .
BACKGROUND	We conducted a series of sensitivity analyses to assess the robustness of the statistical finding and the stability of the estimate of the magnitude of treatment effect on the primary end point of FVC change in a phase 3 trial evaluating pirfenidone in adults with IPF .
METHODS	Source data included all 555 study participants randomized to treatment with pirfenidone or placebo in the Assessment of Pirfenidone to Confirm Efficacy and Safety in Idiopathic Pulmonary Fibrosis ( ASCEND ) study .
METHODS	Sensitivity analyses were conducted to assess whether alternative statistical tests and methods for handling missing data influenced the observed magnitude of treatment effect on the primary end point of change from baseline to week 52 in FVC .
RESULTS	The distribution of FVC change at week 52 was systematically different between the two treatment groups and favored pirfenidone in each analysis .
RESULTS	The method used to impute missing data due to death had a marked effect on the magnitude of change in FVC in both treatment groups ; however , the magnitude of treatment benefit was generally consistent on a relative basis , with an approximate 50 % reduction in FVC decline observed in the pirfenidone group in each analysis .
CONCLUSIONS	Our results confirm the robustness of the statistical finding on the primary end point of change in FVC in the ASCEND trial and corroborate the estimated magnitude of the pirfenidone treatment effect in patients with IPF .
BACKGROUND	ClinicalTrials.gov ; No. : NCT01366209 ; URL : www.clinicaltrials.gov .

###25495390
BACKGROUND	Children whose mothers had low thyroid hormone levels during pregnancy have been reported to have decreased cognitive function .
BACKGROUND	The reported research is part of the follow-on study of the Controlled Antenatal Thyroid Screening Study ( CATS I ) , a randomised controlled trial which investigated the impact of treated vs. untreated low thyroid hormone level in women during pregnancy with the primary outcome being the child 's IQ at age 3 .
BACKGROUND	No significant differences in IQ were found between the treated and untreated groups .
BACKGROUND	These children are now aged between 7 and 10 years and aspects of their cognitive functioning including their IQ are being reassessed as part of CATS II .
METHODS	Cognitive assessments generate an IQ score and further tests administered will investigate long term memory function and motor coordination .
METHODS	The aim is to complete the assessments with 40 % of the children born to mothers either in the treated or untreated low thyroid hormone groups ( n = 120 per group ) .
METHODS	Also children born to mothers who had normal thyroid functioning during CATS I are being assessed for the first time ( n = 240 ) to provide a comparison .
METHODS	Assessments are conducted either in the research facility or the participant 's home .
CONCLUSIONS	The study is designed to assess the cognitive functioning of children born to mothers with low thyroid hormone levels and normal thyroid functioning during pregnancy .
CONCLUSIONS	This is the largest study of its type and also is distinguishable in its longitudinal design .
CONCLUSIONS	The research has the potential to have a significant impact on public health policy in the UK ; universal screening of thyroid hormone levels in pregnancy may be the recommendation .

###24946835
BACKGROUND	Unnecessary ventricular pacing in sinus node disease ( SND ) must be avoided .
BACKGROUND	To test the hypothesis that in SND , with or without 1st degree atrioventricular ( AV ) block , cumulative percent ventricular pacing ( cum % VP ) can be limited by low right atrial septal ( LRAS ) instead of right atrial appendage ( RAA ) pacing .
METHODS	We studied 102 dual-chamber pacemaker recipients with SND .
METHODS	The PQ interval on 12-lead electrocardiogram and the atrial paced to ventricular sensed interval ( Ap-Vs ) during LRAS and RAA pacing were measured and compared at implantation , 3 months and 1 year of follow-up .
METHODS	Group 1 included 62 patients with baseline PQ interval < 200milliseconds during LRAS ( n = 28 ) versus RAA ( n = 34 ) pacing .
METHODS	Group 2 included 40 patients with baseline PQ 200 milliseconds during LRAS ( n = 20 ) versus RAA ( n = 20 ) pacing .
METHODS	cum % VP were measured at 3 months and 1 year .
RESULTS	The characteristics and AV conduction properties were similar and the Ap-Vs interval was significantly shorter in the LRAS than in the RAA pacing group up to 1 year ( 193 32 milliseconds vs. 220 27 milliseconds in Group 1 ; P = 0.003 , 222 41 milliseconds vs. 281 30 milliseconds in Group 2 ; P < 0.001 ) .
RESULTS	While cumulative percent atrial pacing was consistently similar , cum % VP was significantly smaller during LRAS than RAA pacing ( 1 1 % vs. 8 18 % in Group 1 ; P = 0.03 , 7 10 % vs. 48 38 % in Group 2 ; P < 0.001 ) .
RESULTS	Similar observations were made with or without left atrial ( LA ) enlargement .
CONCLUSIONS	Compared with RAA , LRAS pacing showed shorter AV interval in SND patients with or without 1st degree AV block and LA enlargement .
CONCLUSIONS	This beneficial effect persisted through 1-year follow-up , and decreased cum % VP significantly .

###24526709
BACKGROUND	While prior preliminary studies have broadened our understanding of how repetitive transcranial magnetic stimulation ( rTMS ) improves language outcomes in stroke patients with nonfluent aphasia , the evidence base of the effectiveness of this method remains inadequate .
OBJECTIVE	In this study , we aimed to strengthen the evidence that this approach improves language performance and to identify characteristics of patients predisposed to benefit most from this treatment .
METHODS	Fifty-six stroke patients with nonfluent aphasia were randomly allocated to a real or a sham stimulation group : Group A ( n = 33 ) , who underwent 10 sessions of 1-Hz rTMS over the contralesional pars triangularis ( PTr ) , and Group B ( n = 23 ) , who received sham 1-Hz stimulation .
METHODS	We performed the Picture Naming Test and the Concise Chinese Aphasia Test ( CCAT ) at the baseline , post-rTMS intervention , and at 3-month follow-up .
RESULTS	Group A showed significantly greater improvement than Group B in CCAT scoring ( P < .001 ) , object-naming accuracy ( P = .01 ) , and naming reaction time ( P = .004 ) .
RESULTS	The CCAT scoring and naming testing changes for Group A were persistent at 3 months following intervention ( P = .008 ) .
RESULTS	Patients who had a lower contralesional rest motor threshold ( rMT ) were predisposed to a favorable therapeutic outcome ( P = .006 ) , independent of aphasia type , severity , and duration .
CONCLUSIONS	The results of this study provide evidence that inhibitory rTMS , through downregulating the circuitry of the right pars triangularis ( PTr ) , achieves a persistent and broadly modulating effect , irrespective of aphasia severity and subtype .
CONCLUSIONS	Patients who show lower rMT in the right motor system would seem to benefit the most from inhibitory rTMS .

###24341948
OBJECTIVE	The aim of this study was to determine the pharmacokinetic profile of metronidazole ( Mtz ) tablet and to compare Mtz gel and tablet concentrations in both blood plasma and saliva .
METHODS	In this randomized cross-over study with a 1-week washout period , 13 volunteers randomly received one ( a single oral dose of 750 mg Mtz ( Flagyl -- tablet ) and 2 ) 3 g of 15 % Mtz benzoate gel ( applied by using a dental tray ) .
METHODS	The HPLC with ultraviolet detection was used to quantify plasma and saliva concentrations of Mtz .
METHODS	The pharmacokinetic parameters ( PPs ) areas under the curves from 0 to 48 h ( AUC0-48 ) and from 0 to infinity ( AUC0 - ) , the maximum plasma concentration ( C ( max ) ) , the time to C ( max ) , volume of distribution and renal clearance were determined for Mtz tablet .
RESULTS	Considering the Mtz tablet , plasma showed higher Mtz concentration from 6 to 24 h after drug administration and the highest values concerning AUC0-48 h and AUC0 - than those obtained in saliva ( P < 0.05 ) .
RESULTS	No significant differences were observed between plasma and saliva concentrations for Mtz gel .
CONCLUSIONS	The study showed that some PPs were higher in plasma ( P < 0.05 ) than in saliva concerning Mtz tablet .
CONCLUSIONS	Gel formulation had similar Mtz bioavailability in plasma and saliva resulting in systemic absorption .

###24722774
BACKGROUND	Therapy with tenofovir is associated with lower bone mineral density ( BMD ) , higher markers of bone turnover and increased fracture risk in HIV-infected adults .
BACKGROUND	Bone structural parameters generated by hip structural analysis may represent a separate measure of bone strength , but have not been assessed in HIV .
METHODS	Dual-energy X-ray absorptiometry ( DXA ) scans from 254 HIV-infected adults randomised to simplify their existing dual nucleoside analogue reverse transcriptase inhibitor therapy to coformulated tenofovir-emtricitabine or abacavir-lamivudine were analysed using DXA-derived hip structural analysis software .
METHODS	Hip structural parameters included femoral strength index , section modulus , cross-sectional area , and cross-sectional moment of inertia .
METHODS	We used one-way ANOVA to test the relationship between nucleoside analogue type at baseline and structural parameters , multivariable analysis to assess baseline covariates associated with femoral strength index , and t-tests to compare mean change in structural parameters over 96 weeks between randomised groups .
RESULTS	Participants taking tenofovir at baseline had lower section modulus ( -107.3 mm2 , p = 0.001 ) , lower cross-sectional area ( -15.01 mm3 , p = 0.001 ) , and lower cross-sectional moment of inertia ( -2,036.8 mm4 , p = 0.007 ) than those receiving other nucleoside analogues .
RESULTS	After adjustment for baseline risk factors , the association remained significant for section modulus ( p = 0.008 ) and cross-sectional area ( p = 0.002 ) .
RESULTS	Baseline covariates significantly associated with higher femoral strength index were higher spine T-score ( p = 0.001 ) , lower body fat mass ( p < 0.001 ) , lower bone alkaline phosphatase ( p = 0.025 ) , and higher osteoprotegerin ( p = 0.024 ) .
RESULTS	Hip structural parameters did not change significantly over 96 weeks and none was significantly affected by treatment simplification to tenofovir-emtricitabine or abacavir-lamivudine .
CONCLUSIONS	In this population , tenofovir use was associated with reduced composite indices of bone strength as measured by hip structural analysis , but none of the structural parameters improved significantly over 96 weeks with tenofovir cessation .
BACKGROUND	ClinicalTrials.gov NCT00192634 .

###24991038
OBJECTIVE	We examined narrative discourse in amyotrophic lateral sclerosis ( ALS ) to assess the role of executive functioning in support of language and the neuroanatomical basis for such support .
METHODS	We analyzed a semistructured speech sample in 26 patients with ALS and 19 healthy seniors for narrative discourse features of coherence .
METHODS	Regression analyses related a measure of discourse coherence ( `` local connectedness '' ) to gray matter atrophy and reduced white matter fractional anisotropy .
RESULTS	Patients with ALS were impaired relative to controls on measures of discourse adequacy , including local connectedness and maintenance of the theme .
RESULTS	These discourse measures were related to measures of executive functioning but not to motor functioning .
RESULTS	Regressions related local connectedness to gray matter atrophy in ventral and dorsal prefrontal regions and to reduced fractional anisotropy in white matter tracts mediating projections between prefrontal regions .
CONCLUSIONS	Patients with ALS exhibit deficits in their ability to organize narrative discourse .
CONCLUSIONS	These deficits appear to be related in part to executive limitations .
CONCLUSIONS	Consistent with the hypothesis that ALS is a multisystem disorder , this deficit is related to disease in prefrontal regions .

###25023977
BACKGROUND	In spite of the high occurrence of migraine headaches in school-age children , there are currently no approved and widely accepted pharmacologic agents for migraine prophylaxis in children .
BACKGROUND	Our previous open-label study in children revealed the efficacy of cinnarizine , a calcium channel blocker , in migraine prophylaxis .
BACKGROUND	A placebo-controlled trial was conducted to demonstrate the efficacy and safety of cinnarizine in the prophylaxis of migraine in children .
METHODS	A double-blind , placebo-controlled , parallel-group study conducted in a tertiary medical center in Tehran , Iran .
METHODS	Children ( 5-17 years ) who experienced migraines with and without aura , as defined on the basis of 2004 International Headache Society criteria , were recruited into the study .
METHODS	Children were excluded if they had complicated migraine , epilepsy , or a history of use of migraine prophylactic agents .
METHODS	Each participant was randomly assigned to receive cinnarizine ( a single 1.5 mg/kg/day dose in children weighing less than 30 kg and a single 50 mg dose in children weighing more than 30 kg , administered at bedtime ) or placebo .
METHODS	The frequency , severity , and duration of headaches over the trial period were assessed and adverse effects were monitored .
RESULTS	A total of 68 children ( 34 in each group ) with migraine were enrolled and 62 participants completed the study .
RESULTS	After 3 months of taking cinnarizine or placebo , children in both groups experienced significantly reduced frequency , severity , and duration of headaches compared with baseline measurements ( P < 0.001 ) .
RESULTS	However , compared with 31.3 % of children in the placebo group , 60 % of children in the cinnarizine group reported more than 50 % reduction in monthly headache frequency ( P = 0.023 ) , suggesting that cinnarizine was significantly more effective than placebo in reducing the frequency of headaches .
RESULTS	No serious adverse effects of the medications were observed in the treated children , including no abnormal weight gain or extrapyramidal signs .
CONCLUSIONS	Our results indicate that the use of cinnarizine at doses administered in this study is effective and safe for prophylaxis of migraine headaches in children .

###26009829
BACKGROUND	Among patients with HIV infection , changes in the kidney filtration marker cystatin C after initiation of antiretroviral therapy ( ART ) may be related to changes in body composition or biomarkers of inflammation .
METHODS	ACTG A5224s was a substudy of A5202 , which randomly assigned ART-naive HIV-infected subjects to blinded abacavir/lamivudine ( ABC/3TC ) or tenofovir/emtricitabine ( TDF/FTC ) with open-label efavirenz ( EFV ) or ritonavir-boosted atazanavir .
METHODS	This analysis explored changes in cystatin C from 0 to 96 weeks .
RESULTS	Of the 269 subjects , 85 % were male and 66 % white non-Hispanics ; baseline mean CD4 count was 236 cells per cubic millimeter and cystatin C was 0.89 mg/L .
RESULTS	Cystatin C decreased significantly within each arm ; however , ritonavir-boosted atazanavir attenuated the beneficial effects of ART on cystatin C compared to EFV .
RESULTS	Compared to ABC/3TC , TDF/FTC led to a marginally significant attenuation for percent change analyses only .
RESULTS	Higher baseline body mass index and HIV RNA were associated with larger reductions in cystatin C in multivariable models .
RESULTS	At baseline , cystatin C was positively correlated with high-sensitivity C-reactive protein ( Spearman r = 0.25 ) , interleukin 6 ( r = 0.34 ) , soluble intercellular adhesion molecule ( r = 0.36 ) , soluble vascular cell adhesion molecule ( r = 0.54 ) , tumor necrosis factor ( r = 0.57 ) , and soluble TNF - receptor I ( r = 0.70 , all P < 0.001 ) .
RESULTS	Reductions in cystatin C from 0 to 96 weeks correlated with reductions in all inflammatory biomarkers ( r = 0.39-0 .58 , P < 0.001 ) except for high-sensitivity C-reactive protein ( r = 0.01 , P = 0.89 ) and IL-6 ( r = 0.08 , P = 0.24 ) .
CONCLUSIONS	The beneficial effect of ART on cystatin C concentrations is attenuated by boosted ATV when compared to EFV .
CONCLUSIONS	Reductions in cystatin C after ART are associated with reductions in systemic inflammation .

###25589191
BACKGROUND	We aimed to assess the effect of afatinib on overall survival of patients with EGFR mutation-positive lung adenocarcinoma through an analysis of data from two open-label , randomised , phase 3 trials .
METHODS	Previously untreated patients with EGFR mutation-positive stage IIIB or IV lung adenocarcinoma were enrolled in LUX-Lung 3 ( n = 345 ) and LUX-Lung 6 ( n = 364 ) .
METHODS	These patients were randomly assigned in a 2:1 ratio to receive afatinib or chemotherapy ( pemetrexed-cisplatin [ LUX-Lung 3 ] or gemcitabine-cisplatin [ LUX-Lung 6 ] ) , stratified by EGFR mutation ( exon 19 deletion [ del19 ] , Leu858Arg , or other ) and ethnic origin ( LUX-Lung 3 only ) .
METHODS	We planned analyses of mature overall survival data in the intention-to-treat population after 209 ( LUX-Lung 3 ) and 237 ( LUX-Lung 6 ) deaths .
METHODS	These ongoing studies are registered with ClinicalTrials.gov , numbers NCT00949650 and NCT01121393 .
RESULTS	Median follow-up in LUX-Lung 3 was 41 months ( IQR 35-44 ) ; 213 ( 62 % ) of 345 patients had died .
RESULTS	Median follow-up in LUX-Lung 6 was 33 months ( IQR 31-37 ) ; 246 ( 68 % ) of 364 patients had died .
RESULTS	In LUX-Lung 3 , median overall survival was 28.2 months ( 95 % CI 24.6-33 .6 ) in the afatinib group and 28.2 months ( 20.7-33 .2 ) in the pemetrexed-cisplatin group ( HR 0.88 , 95 % CI 0.66-1 .17 , p = 0.39 ) .
RESULTS	In LUX-Lung 6 , median overall survival was 23.1 months ( 95 % CI 20.4-27 .3 ) in the afatinib group and 23.5 months ( 18.0-25 .6 ) in the gemcitabine-cisplatin group ( HR 0.93 , 95 % CI 0.72-1 .22 , p = 0.61 ) .
RESULTS	However , in preplanned analyses , overall survival was significantly longer for patients with del19-positive tumours in the afatinib group than in the chemotherapy group in both trials : in LUX-Lung 3 , median overall survival was 33.3 months ( 95 % CI 26.8-41 .5 ) in the afatinib group versus 21.1 months ( 16.3-30 .7 ) in the chemotherapy group ( HR 0.54 , 95 % CI 0.36-0 .79 , p = 0.0015 ) ; in LUX-Lung 6 , it was 31.4 months ( 95 % CI 24.2-35 .3 ) versus 18.4 months ( 14.6-25 .6 ) , respectively ( HR 0.64 , 95 % CI 0.44-0 .94 , p = 0.023 ) .
RESULTS	By contrast , there were no significant differences by treatment group for patients with EGFR Leu858Arg-positive tumours in either trial : in LUX-Lung 3 , median overall survival was 27.6 months ( 19.8-41 .7 ) in the afatinib group versus 40.3 months ( 24.3-not estimable ) in the chemotherapy group ( HR 1.30 , 95 % CI 0.80-2 .11 , p = 0.29 ) ; in LUX-Lung 6 , it was 19.6 months ( 95 % CI 17.0-22 .1 ) versus 24.3 months ( 19.0-27 .0 ) , respectively ( HR 1.22 , 95 % CI 0.81-1 .83 , p = 0.34 ) .
RESULTS	In both trials , the most common afatinib-related grade 3-4 adverse events were rash or acne ( 37 [ 16 % ] of 229 patients in LUX-Lung 3 and 35 [ 15 % ] of 239 patients in LUX-Lung 6 ) , diarrhoea ( 33 [ 14 % ] and 13 [ 5 % ] ) , paronychia ( 26 [ 11 % ] in LUX-Lung 3 only ) , and stomatitis or mucositis ( 13 [ 5 % ] in LUX-Lung 6 only ) .
RESULTS	In LUX-Lung 3 , neutropenia ( 20 [ 18 % ] of 111 patients ) , fatigue ( 14 [ 13 % ] ) and leucopenia ( nine [ 8 % ] ) were the most common chemotherapy-related grade 3-4 adverse events , while in LUX-Lung 6 , the most common chemotherapy-related grade 3-4 adverse events were neutropenia ( 30 [ 27 % ] of 113 patients ) , vomiting ( 22 [ 19 % ] ) , and leucopenia ( 17 [ 15 % ] ) .
CONCLUSIONS	Although afatinib did not improve overall survival in the whole population of either trial , overall survival was improved with the drug for patients with del19 EGFR mutations .
CONCLUSIONS	The absence of an effect in patients with Leu858Arg EGFR mutations suggests that EGFR del19-positive disease might be distinct from Leu858Arg-positive disease and that these subgroups should be analysed separately in future trials .
BACKGROUND	Boehringer Ingelheim .

###25684006
OBJECTIVE	This study was to evaluate the characteristics of selective spinal anesthesia using 1 mg of bupivacaine combined with fentanyl or sufentanil in elderly patients undergoing transurethral resection of prostate .
METHODS	Fifty-six patients were randomized into two groups .
METHODS	The Fentanyl group received 0.5 % hyperbaric bupivacaine 0.2 mL + fentanyl 20 g +5 % dextrose 1.4 mL , and the Sufentanil group received 0.5 % hyperbaric bupivacaine 0.2 mL + sufentanil 5 g +5 % dextrose 1.7 mL intrathecally .
METHODS	Intraoperative and postoperative characteristics were evaluated .
METHODS	Patient satisfaction was assessed postoperatively .
RESULTS	Twenty-six patients in each group completed the study .
RESULTS	The median peak sensory block level was similar between two groups , but sensory regression time was longer in the Sufentanil group than the Fentanyl group ( p = 0.017 ) .
RESULTS	All patients were able to move themselves to the bed without any aid when they arrived at the admission room .
RESULTS	Pain scores were lower in the Sufentanil group than the Fentanyl group at postoperative 6 , 12 , and 18 hours ( p = 0.001 ) .
RESULTS	Compared to the Fentanyl group , the Sufentanil group required less postoperative analgesia ( p = 0.023 ) and the time to the first analgesic request was longer ( p = 0.025 ) .
RESULTS	Twenty-four of 26 patients ( 92.3 % ) in each group showed `` good '' satisfaction level .
CONCLUSIONS	Selective spinal anesthesia using 1 mg of bupivacaine with fentanyl or sufentanil provided appropriate sensory block level with spared motor function for transurethral resection of the prostate in elderly patients .
CONCLUSIONS	Intrathecal sufentanil was superior to fentanyl in postoperative analgesic quality .

###25925670
BACKGROUND	Angina pectoris ( Angina ) is a medical condition related to myocardial ischemia .
BACKGROUND	Although acupuncture has been widely accepted as a clinical approach for angina , there is no sufficient evidence of its effectiveness against this syndrome , and its mechanisms have not yet been well elucidated .
BACKGROUND	We develop this protocol to confirm the clinical efficacy of electro-acupuncture on stable angina pectoris by needling on acupoint Neiguan ( PC6 ) .
BACKGROUND	Furthermore , we employ high-throughput sequencing technology to investigate the gene expression profiling and determine involvement of histone modifications in the regulation of genes after electro-acupuncture treatment .
METHODS	A randomized , controlled , double-blinded ( assessor and patients ) trial will be carried out .
METHODS	Sixty participants will be randomly assigned to two acupuncture treatment groups and one control group in a 1:1:1 ratio .
METHODS	Participants in acupuncture groups will receive 12 sessions of electro-acupuncture treatment across 4 weeks , followed by a 12-week randomization period .
METHODS	The acupuncture groups are divided into Neiguan ( PC6 ) on Pericardium Meridian of Hand-jueyin or a non-acupoint .
METHODS	The primary clinical measure of effect is the frequency of angina attacks between these groups for four weeks after randomization .
METHODS	RNAs are extracted from peripheral neutrophils collected from all participants on day 0 , day 30 , and week 16 , and are processed to RNA-Seq .
METHODS	We then investigate profiles of histone modifications by ChIP-Seq , for H3 Lysine 4 ( H3K4me ) and acetylation of H3 Lysine 27 ( H3K27ac ) , in the presence or absence of acupuncture treatment .
CONCLUSIONS	This study determines the efficacy and mechanisms of electro-acupuncture on stable angina pectoris .
CONCLUSIONS	We focus on effectiveness of acupuncture on alleviating symptoms of myocardial ischemia and the gene regulation and the chromatin remodeling marks , including H3K4me1 , H3K4me2 , and H3K27ac , which could be key factors for regulating gene expressions caused by electro-acupuncture treatment at Neiguan .
CONCLUSIONS	This is the first genome-wide study of electro-acupuncture treatment in angina patients , and will provide valuable information for future studies in the fields of acupuncture and its underlying mechanisms .
CONCLUSIONS	Fourteen patients have been recruited since recruitment opened in November of 2012 .
CONCLUSIONS	This study is scheduled to end in November of 2014 .
BACKGROUND	ChiCTR-TRC-12002668 .

###24639423
OBJECTIVE	Despite prompt revascularization of acute myocardial infarction ( AMI ) , substantial myocardial injury may occur , in part a consequence of ischaemia reperfusion injury ( IRI ) .
OBJECTIVE	There has been considerable interest in therapies that may reduce IRI .
OBJECTIVE	In experimental models of AMI , sodium nitrite substantially reduces IRI .
OBJECTIVE	In this double-blind randomized placebo controlled parallel-group trial , we investigated the effects of sodium nitrite administered immediately prior to reperfusion in patients with acute ST-elevation myocardial infarction ( STEMI ) .
RESULTS	A total of 229 patients presenting with acute STEMI were randomized to receive either an i.v. infusion of 70 mol sodium nitrite ( n = 118 ) or matching placebo ( n = 111 ) over 5 min immediately before primary percutaneous intervention ( PPCI ) .
RESULTS	Patients underwent cardiac magnetic resonance imaging ( CMR ) at 6-8 days and at 6 months and serial blood sampling was performed over 72 h for the measurement of plasma creatine kinase ( CK ) and Troponin I. Myocardial infarct size ( extent of late gadolinium enhancement at 6-8 days by CMR-the primary endpoint ) did not differ between nitrite and placebo groups after adjustment for area at risk , diabetes status , and centre ( effect size -0.7 % 95 % CI : -2.2 % , +0.7 % ; P = 0.34 ) .
RESULTS	There were no significant differences in any of the secondary endpoints , including plasma troponin I and CK area under the curve , left ventricular volumes ( LV ) , and ejection fraction ( EF ) measured at 6-8 days and at 6 months and final infarct size ( FIS ) measured at 6 months .
CONCLUSIONS	Sodium nitrite administered intravenously immediately prior to reperfusion in patients with acute STEMI does not reduce infarct size .

###24716545
BACKGROUND	The Danish health care sector is reorganising based on disease management programmes designed to secure integrated and high quality chronic care across hospitals , general practitioners and municipalities .
BACKGROUND	The disease management programmes assign a central role to general practice ; and in the Capital Region of Denmark a facilitator-based intervention was undertaken to support the implementation of the programmes in general practice .
BACKGROUND	The purpose of the study was to assess the effectiveness of this semi-tailored facilitator-based intervention .
METHODS	The study was a stepped-wedge , randomised , controlled trial among general practices in the Capital Region of Denmark .
METHODS	The intervention group was offered three one-hour visits by a facilitator .
METHODS	The intervention was semi-tailored to the perceived needs as defined by each general practice , and the practices could choose from a list of possible topics .
METHODS	The control group was a delayed intervention group .
METHODS	The primary outcome was change in the number of annual chronic disease check-ups .
METHODS	Secondary outcomes were : changes in the number of annual check-ups for type 2 diabetes ( DM2 ) and chronic obstructive pulmonary disease ( COPD ) ; changes in the number of spirometry tests , changes in the use of ICPC diagnosis coding and patient stratification ; sign-up for a software program for patient overview ; and reduction in number of practices with few annual chronic disease check-ups .
RESULTS	We randomised 189 general practices : 96 practices were allocated to the intervention group and 93 to the delayed intervention group .
RESULTS	For the primary outcome , 94 and 89 practices were analysed .
RESULTS	Almost every outcome improved from baseline to follow-up in both allocation groups .
RESULTS	At follow-up there was no difference between allocation groups for the primary outcome ( p = 0.1639 ) .
RESULTS	However , some secondary outcomes favoured the intervention : a higher reported use of ICPC diagnosis coding for DM2 and COPD ( p = 0.0050 , p = 0.0243 respectively ) , stratification for COPD ( p = 0.0185 ) and a faster initial sign-up rate for the software program .
CONCLUSIONS	The mixed results from this study indicate that a semi-tailored facilitator-based intervention of relatively low intensity is unlikely to add substantially to the implementation of disease management programmes for DM2 and COPD in a context marked by important concurrent initiatives ( including financial incentives and mandatory registry participation ) aimed at moving all practices towards changes in chronic care .
BACKGROUND	ClinicalTrials.gov : NCT01297075 .

###25588441
OBJECTIVE	To compare the incidence of infection after minor surgery conducted using non-sterile clean boxed gloves with surgery conducted using sterile gloves .
METHODS	Prospective randomised controlled single-centre trial testing for non-inferiority in infection rates .
METHODS	Primary care regional centre , Queensland , Australia .
METHODS	Consecutive patients presenting to participating general practitioners for a minor skin excision , between 30 June 2012 and 28 March 2013 , were eligible to participate .
METHODS	The use of non-sterile clean boxed gloves was compared with normal treatment using sterile gloves in the control group .
METHODS	Wound infection , assessed at the time of removal of sutures , and other adverse events .
RESULTS	Four hundred and ninety-three consecutive patients presenting for minor skin excisions were randomly allocated to the two treatment groups : non-sterile clean boxed gloves ( n = 250 ) or sterile gloves ( n = 243 ) .
RESULTS	Four hundred and seventy-eight patients contributed data for analysis ( 241 non-sterile , 237 sterile gloves ) .
RESULTS	The incidence of infection in the non-sterile gloves group ( 8.7 % ; 95 % CI , 4.9 % -12.6 % ) was significantly non-inferior compared with the incidence in the control group ( 9.3 % ; 95 % CI , 7.4 % -11.1 % ) .
RESULTS	The two-sided 95 % CI for the difference in infection rate ( - 0.6 % ) was - 4.0 % to 2.9 % , and did not reach the predetermined margin of 7 % which had been assumed as the non-inferiority limit .
RESULTS	RESULTS of the intention-to-treat analysis were confirmed by per-protocol and sensitivity analyses .
RESULTS	There were no important adverse effects .
CONCLUSIONS	Our study suggests that in regard to wound infection , non-sterile clean boxed gloves are not inferior to sterile gloves for minor skin excisions in general practice .
BACKGROUND	ACTRN12612000698875 .

###24684171
OBJECTIVE	Reports of the accuracy of existing neuromonitoring methods for detecting or preventing medial malpositioning of thoracic pedicle screws have varied widely in their claimed effectiveness .
OBJECTIVE	The object of this study was to develop , test , and validate a novel neuromonitoring method for preventing medial malpositioning of pedicle screws in the thoracic spine during surgery .
METHODS	This is a prospective , blinded and randomized study using a novel combination of input ( 4-pulse stimulus trains delivered within the pedicle track ) and output ( evoked electromyography from leg muscles ) to detect pedicle track trajectories that-once implanted with a screw-would cause that screw to breach the pedicle 's medial wall and encroach upon the spinal canal .
METHODS	For comparison , the authors also used screw stimulation as an input and evoked electromyogram from intercostal and abdominal muscles as output measures .
METHODS	Intraoperative electrophysiological findings were compared with postoperative CT scans by multiple reviewers blinded to patient identity or intraoperative findings .
RESULTS	Data were collected from 71 patients , in whom 802 screws were implanted between the T-1 and L-1 vertebral levels .
RESULTS	A total of 32 screws ended up with screw threads encroaching on the spinal canal by at least 2 mm .
RESULTS	Pulse-train stimulation within the pedicle track using a ball-tipped probe and electromyography from lower limb muscles correctly predicted all 32 ( 100 % ) of these medially malpositioned screws .
RESULTS	The combination of pedicle track stimulation and electromyogram response from leg muscles proved to be far more effective in predicting these medially malpositioned screws than was direct screw stimulation and any of the target muscles ( intercostal , abdominal , or lower limb muscles ) we monitored .
RESULTS	Based on receiver operating characteristic analysis , the combination of 10-mA ( lower alarm ) and 15-mA stimulation intensities proved most effective for detection of pedicle tracks that ultimately gave rise to medially malpositioned screws .
RESULTS	Additional results pertaining to the impact of feedback of these test results on surgical decision making are provided in the companion report .
CONCLUSIONS	This novel neuromonitoring approach accurately predicts medially malpositioned thoracic screws .
CONCLUSIONS	The approach could be readily implemented within any surgical program that is already using contemporary neuromonitoring methods that include transcranial stimulation for monitoring motor evoked potentials .

###25230559
BACKGROUND	Oxidative stress is involved in lead toxicity .
BACKGROUND	This suggests that some antioxidants may play a role in the treatment of lead poisoning .
BACKGROUND	In the light of this , the aim of the study was to determine whether beta-carotene administration reduces oxidative stress and homocysteine level in workers chronically exposed to lead .
METHODS	The exposed population included healthy male workers exposed to lead who were randomly divided into 2 groups ( mean blood lead level ca. 44 microg/dl ) .
METHODS	Workers in the 1st group ( N = 49 , reference group ) had no antioxidants , drugs , vitamins or dietary supplements administered , while workers in the 2nd group ( N = 33 ) had beta-carotene administered in a dose of 10 mg per day for 12 weeks .
METHODS	Biochemical analysis included markers of lead-exposure and the level of malondialdehyde ( MDA ) , an oxidative stress biomarker .
METHODS	We also measured the level of homocysteine ( Hcy ) and thiol groups as well as the activity of superoxide dismutase ( SOD ) and its isoenzyme EC-SOD in serum .
RESULTS	After supplementation , the level of MDA significantly decreased , compared to baseline , by 16 % , and to the reference group .
RESULTS	When compared to the reference group , Hcy level was also significantly decreased .
RESULTS	However , the level of thiol groups was significantly higher after supplementation with beta-carotene compared to the reference group .
RESULTS	Analogically , the activity of SOD and EC-SOD was significantly higher compared to the baseline and to the reference group .
CONCLUSIONS	Despite some controversies over antioxidant properties of beta-carotene , our results indicate that its antioxidant action could provide some beneficial effects in lead poisoning independent of chelation .

###25784723
BACKGROUND	Public-health guidelines recommend patients with congenital heart disease to exercise .
BACKGROUND	Studies have shown that patients with congenital heart disease can improve physical exercise capacity .
BACKGROUND	The effect of training on regional ventricular performance has hardly been studied .
BACKGROUND	We performed a pilot study to assess whether an exercise training program would result in adverse changes of regional ventricular performance in patients with corrected tetralogy of Fallot .
RESULTS	Multicenter prospective randomized controlled pilot study in patients with tetralogy of Fallot aged 10 to 25 years .
RESULTS	A 12-week standardized aerobic dynamic exercise training program ( 3 one-hour sessions per week ) was used .
RESULTS	Pre - and post-training cardiopulmonary exercise tests , MRI , and echocardiography , including tissue-Doppler imaging , were performed .
RESULTS	Patients were randomized to the exercise group ( n = 28 ) or control group ( n = 20 ) .
RESULTS	One patient in the exercise group dropped out .
RESULTS	Change in tissue-Doppler imaging parameters was similar in the exercise group and control group ( change in right ventricle free wall peak velocity E ' exercise group , 0.82.6 cm/s ; control group , 0.94.1 ; peak velocity A ' exercise group , 0.42.4 m/s ; control group 4.618.1 cm/s ) .
CONCLUSIONS	This randomized controlled pilot study provides preliminary data suggesting that regional ventricular performance is well maintained during 3-month aerobic dynamic exercise training in children and young adults with repaired tetralogy of Fallot .
CONCLUSIONS	This information might help patients adhere to current public-health guidelines .
BACKGROUND	URL : http / / : www.trialregister.nl .
BACKGROUND	Unique identifier : NTR2731 .

###25585069
BACKGROUND	Incident syphilis infections continue to be especially prevalent among a core group of HIV-infected men who have sex with men ( MSM ) .
BACKGROUND	Because of synergy between syphilis and HIV infections , innovative means for controlling incident syphilis infections are needed .
METHODS	Thirty MSM who had syphilis twice or more since their HIV diagnosis were randomized to receive either daily doxycycline prophylaxis or contingency management ( CM ) with incentive payments for remaining free of sexually transmitted diseases ( STDs ) .
METHODS	Participants were tested for the bacterial STDs gonorrhea ( Neisseria gonorrhoeae ) , chlamydia ( Chlamydia trachomatis ) and syphilis at weeks 12 , 24 , 36 , and 48 and completed a behavioral risk questionnaire during each visit to assess number of partners , condom use , and drug use since the last visit .
METHODS	Generalized linear mixed models were used to analyze differences between arms in STD incidence and risk behaviors at follow-up .
RESULTS	Doxycycline arm participants were significantly less likely to test positive for any selected bacterial STD during 48 weeks of follow-up ( odds ratio , 0.27 ; confidence interval , 0.09-0 .83 ) compared with CM arm participants ( P = 0.02 ) .
RESULTS	There were no significant self-reported risk behavior differences between the doxycycline and CM arms at follow-up .
CONCLUSIONS	Daily doxycycline taken prophylactically was associated with a decreased incidence of N. gonorrhoeae , C. trachomatis , or syphilis incident infections among a core group of HIV-infected MSM at high risk for these infections .
CONCLUSIONS	Safe and effective biomedical tools should be included in the efforts to control transmission of syphilis , especially in this population .
CONCLUSIONS	A randomized clinical trial should be conducted to confirm and extend these findings .

###24912063
OBJECTIVE	The individual placement and support ( IPS ) model of supported employment has been implemented throughout North America and Europe , with multiple randomized controlled trials documenting its effectiveness , but it has not been widely implemented in Asia .
OBJECTIVE	To date , no rigorous evaluations of IPS have been conducted in Japan .
OBJECTIVE	We sought to evaluate whether IPS could be implemented in Japan and produce superior competitive employment outcomes compared with conventional vocational services .
METHODS	We employed a randomized controlled trial with a 6-month follow-up ; 18 participants were randomly assigned to IPS and 19 to conventional vocational services .
METHODS	We assessed competitive employment rates , hours and weeks worked , and wages earned .
RESULTS	Over the 6-month follow-up period , IPS participants were more likely than those in usual care to work competitively ( 44.4 % for IPS vs. 10.5 % for controls , p = .022 ) , work more hours ( mean of 168 hr for IPS vs. 41 hr for controls , p = .002 ) , and work more weeks ( mean of 6.4 weeks for IPS vs. 1.8 weeks for controls , p = .003 ) .
CONCLUSIONS	IPS can be implemented in Japan and yield better competitive employment outcomes than conventional vocational services .
CONCLUSIONS	Adoption of the IPS model might have a dramatic impact on the mental health service system in Japan where psychiatric hospitals play a central role in mental health care .

###24636266
BACKGROUND	Procalcitonin-guided antibiotic therapy for community-acquired pneumonia is effective and safe .
BACKGROUND	However , the usefulness of procalcitonin for aspiration pneumonia and its nutrition-related outcomes are unknown .
METHODS	We conducted a noninferiority randomized controlled study in patients with aspiration pneumonia who were admitted to our hospital between September 2010 and January 2012 .
METHODS	We randomly assigned 105 patients to groups with different durations of antibiotic therapy based on the procalcitonin levels upon admission ( procalcitonin group ) or according to the standard guidelines ( control group ) .
METHODS	The primary endpoints were relapse of aspiration pneumonia and death within 30 days , with a predefined noninferiority boundary of 10 % .
METHODS	Secondary endpoints included duration of antibiotic exposure .
METHODS	Furthermore , we conducted a retrospective analysis of the prognostic factors that determined continuation of oral nutritional intake , relapse of pneumonia , and in-hospital death .
RESULTS	The rate of relapse and death within 30 days were similar in the procalcitonin and control groups ( 25 % versus 37.5 % ; difference , -12.5 % ; 95 % confidence interval , -30.9 % to 5.9 % ) .
RESULTS	Procalcitonin-guided antibiotic therapy significantly shortened the median duration of antibiotic exposure ( 5 versus 8 days ; p < 0.0001 ) ; however , the continuation of oral intake was not increased ( 56 % versus 50 % ; p = 0.54 ) .
RESULTS	A multivariable analysis showed a significant association between the continuation of oral nutritional intake and the body mass index upon admission .
CONCLUSIONS	Procalcitonin-guided antibiotic therapy for aspiration pneumonia can shorten the duration of antibiotic exposure , but it does not increase the continuation of oral intake ( UMIN000004800 ) .

###24796047
OBJECTIVE	To evaluate the clinical efficacy of acupuncture for treatment of diarrhea-predominant irritable bowel syndrome and discuss its action mechanism .
METHODS	Fifty-seven cases were randomly divided into two groups .
METHODS	The acupuncture group ( 29 cases ) was treated with acupuncture at Taichong ( LR 3 ) , Zusanli ( ST 36 ) and Sanyinjiao ( SP 6 ) etc. , once a day and 5 times per week .
METHODS	The medication group ( 28 cases ) was treated with oral administration of pinaverium ( 50 mg each time , 3 times a day ) and live combined bifidobacterium and lactobacillus tablet ( 4 tablets each time , 3 times a day ) .
METHODS	Four weeks were taken as a treatment course in both groups .
METHODS	Before and after treatment ELISA method was applied to measure the level of serum 5-HT of the patients in two groups .
METHODS	The scores of clinical symptoms were observed before treatment , after one and four weeks of treatment and 3 months after treatment , respectively .
RESULTS	The level of serum 5-HT was significantly reduced in the acupuncture group and medication group ( P < 0.01 , P < 0.05 ) , which had no statistical difference between two groups ( P > 0.05 ) .
RESULTS	Compared with the medication group , the scores of clinical symptoms were obviously improved in the acupuncture group after one and four weeks of treatment and 3 months after treatment ( P < 0.01 , P < 0.05 ) .
RESULTS	The total effective rate was 89.66 % ( 26/29 ) in the acupuncture group , which was superior to 67.85 % ( 19/28 ) in the medication group ( P < 0.05 ) .
CONCLUSIONS	The efficacy of acupuncture is superior to that of medicine in the treatment of diarrhea-predominant irritable bowel syndrome .
CONCLUSIONS	The acupuncture treatment could reduce the visceral sensitivity , improve the intestinal motility and regulate the imbalance of brain-intestine interactive function .

###24762631
BACKGROUND	Recurrent Clostridium difficile infection ( CDI ) with poor response to standard antimicrobial therapy is a growing medical concern .
BACKGROUND	We aimed to investigate the outcomes of fecal microbiota transplant ( FMT ) for relapsing CDI using a frozen suspension from unrelated donors , comparing colonoscopic and nasogastric tube ( NGT ) administration .
METHODS	Healthy volunteer donors were screened and a frozen fecal suspension was generated .
METHODS	Patients with relapsing/refractory CDI were randomized to receive an infusion of donor stools by colonoscopy or NGT .
METHODS	The primary endpoint was clinical resolution of diarrhea without relapse after 8 weeks .
METHODS	The secondary endpoint was self-reported health score using standardized questionnaires .
RESULTS	A total of 20 patients were enrolled , 10 in each treatment arm .
RESULTS	Patients had a median of 4 ( range , 2-16 ) relapses prior to study enrollment , with 5 ( range , 3-15 ) antibiotic treatment failures .
RESULTS	Resolution of diarrhea was achieved in 14 patients ( 70 % ) after a single FMT ( 8 of 10 in the colonoscopy group and 6 of 10 in the NGT group ) .
RESULTS	Five patients were retreated , with 4 obtaining cure , resulting in an overall cure rate of 90 % .
RESULTS	Daily number of bowel movements changed from a median of 7 ( interquartile range [ IQR ] , 5-10 ) the day prior to FMT to 2 ( IQR , 1-2 ) after the infusion .
RESULTS	Self-ranked health score improved significantly , from a median of 4 ( IQR , 2-6 ) before transplant to 8 ( IQR , 5-9 ) after transplant .
RESULTS	No serious or unexpected adverse events occurred .
CONCLUSIONS	In our initial feasibility study , FMT using a frozen inoculum from unrelated donors is effective in treating relapsing CDI .
CONCLUSIONS	NGT administration appears to be as effective as colonoscopic administration .
BACKGROUND	NCT01704937 .

###24758077
OBJECTIVE	To observe the effect of catgut implantation at acupoint on the content of tumor necrosis factor alpha ( TNF-alpha ) , and to explore its mechanism for treatment of ankylosing spondylitis ( AS ) .
METHODS	Seventy-four AS patients were randomly assigned to the observation group and the control group by digit random table , 37 in each group .
METHODS	Patients in the control group took Sulfasalazine Enteric-coated Tablet ( SECT ) , 0.5 g each time , three times daily for 3 months .
METHODS	Those in the observation group additionally received catgut implantation at acupoint for 3 months .
METHODS	Changes of visual analogue scale ( VAS ) , Schober test , pillow wall distance , thoracic activity , erythrocyte sedimentation rate ( ESR ) , C reactive protein ( CRP ) , and TNF-alpha were compared after 3 months of treatment .
RESULTS	There was obvious change in VAS , Schober test , pillow wall distance , thoracic activity , ESR , CRP , and TNF-alpha after treatment in the both groups , showing statistical difference when compared with before treatment ( P < 0.05 , P < 0.01 ) .
RESULTS	The aforesaid indices were obviously improved after treatment in the observation group ( P < 0.05 , P < 0.01 ) .
CONCLUSIONS	Catgut implantation at acupoint , as an assistant therapy , could significantly improve clinical symptoms and signs , decrease the level of TNF-alpha , and its effect was superior to that of oral SECT administration alone .

###24929889
OBJECTIVE	In Scotland most women get emergency contraception ( EC ) from pharmacies .
OBJECTIVE	Pharmacists currently can not provide effective ongoing contraception after EC .
OBJECTIVE	In this pilot study , we aimed to determine the feasibility of a larger study designed to ascertain if pharmacy-based interventions can increase the uptake of effective contraception after EC .
METHODS	This is a pilot study of women presenting for levonorgestrel EC to community pharmacies in Edinburgh , UK , in 2012 .
METHODS	Pharmacies were cluster randomized to provide either standard care or one of two interventions : ( a ) one packet of progestogen-only pills ( POPs ) , giving women 1 month to arrange ongoing contraception ; ( b ) invitation to present the empty EC packet to a family planning clinic ( FPC ) for contraceptive advice ( rapid access ) .
RESULTS	One hundred sixty-eight women were recruited from 11 pharmacies to POP ( n = 56 ) , rapid access ( n = 58 ) and standard care ( N = 54 ) groups , respectively .
RESULTS	Telephone follow-up was conducted successfully in 102 women ( 61 % ) 6-8 weeks later to determine current contraceptive use .
RESULTS	In the POP arm , 35/39 ( 90 % ) women used the pills provided , and 9/28 women ( 32 % ) in the rapid access arm attended the FPC .
RESULTS	The proportion of women using effective contraception at follow-up was significantly greater in both POP [ 56 % ( 22/39 ) , p = < 0.001 ] and rapid access [ 52 % ( 13/25 ) , p = 0.006 ] groups compared to standard care [ 16 % ( 5/31 ) ] .
RESULTS	The relative probability of a woman using an effective method of contraception versus barrier/no method , after use of EC , was 3.13 [ 95 % confidence interval ( CI ) , 1.90-5 .13 ] in the POP group and 2.57 ( 95 % CI , 1.55-4 .27 ) in the rapid access group .
CONCLUSIONS	This promising pilot study suggests that simple pharmacy-based interventions may increase the uptake of effective contraception after EC .
CONCLUSIONS	A larger study is required to provide further validation of these findings .
CONCLUSIONS	For women obtaining EC from a pharmacy , simple interventions such as supplying 1 month of a POP , or offering rapid access to a FPC , hold promise as strategies to increase the uptake of effective contraception after EC .

###24667753
OBJECTIVE	Dietary triacylglycerols ( TAGs ) containing palmitic acid in the sn-2 position might impair insulin release and increase plasma glucose .
OBJECTIVE	We tested this hypothesis by comparing postprandial responses to fats with varying proportions of palmitic acid in the sn-2 position .
METHODS	Using a crossover-designed randomized controlled trial in healthy men ( n = 25 ) and women ( n = 25 ) , we compared four meals on postprandial changes in glucose ( primary outcome ) , insulin , C-peptide , glucose , glucose-dependent insulinotropic polypeptide ( GIP ) and polypeptide YY ( PYY ) concentrations .
METHODS	The meals provided 14g protein , 85g carbohydrate and 50g test fat , supplied as high oleic sunflower ( HOS ) oil ( control ) , palm olein ( PO ) , interesterified palm olein ( IPO ) and lard containing 0.6 , 9.2 , 39.1 and 70.5 mol % palmitic acid at sn-2 , respectively .
RESULTS	No differences in plasma glucose , insulin and C-peptide response between meals were found .
RESULTS	GIP release was lower ( P < 0.001 ) for IPO and lard compared with HOS and PO meals ; the maximal increments ( geometric mean and 95 % confidence interval ) for HOS , PO , IPO and lard were 515 ( 468 , 569 ) , 492 ( 448 , 540 ) , 398 ( 350 , 452 ) and 395 ( 364 , 429 ) ng/l , respectively .
RESULTS	There was a trend for the postprandial increase in PYY to be lower in women on the IPO and lard meals than those on the HOS and PO meals .
CONCLUSIONS	Dietary TAGs with an increased proportion of palmitic acid in the sn-2 position do not have acute adverse effects on the insulin and glucose response to meals in healthy men and women , but they decrease GIP release .

###24491072
OBJECTIVE	Although recent studies have documented high-risk drinking occurring during Spring Break ( SB ) , particularly on SB trips with friends , published intervention studies are few .
OBJECTIVE	In the present study , we evaluated the efficacy of event specific prevention strategies for reducing SB drinking among college students , compared to general prevention strategies and an assessment-only control group , as well as evaluated inclusion of peers in interventions and mode of intervention delivery ( in-person vs. web ) .
METHODS	Participants included 783 undergraduates ( 56.1 % women ; average age = 20.5 years ) intending to go on a SB trip with friends as well as to drink heavily on at least 1 day of SB .
METHODS	Participants completed assessments prior to SB and were randomized to 1 of 5 intervention conditions : SB in-person Brief Alcohol Screening and Intervention for College Students ( BASICS ; Dimeff , Baer , Kivlahan , & Marlatt , 1999 ) , SB web BASICS , SB in-person BASICS with friend , SB web BASICS with friend , general BASICS , or an attention control condition .
METHODS	Follow-up assessment was completed 1 week after SB .
RESULTS	Although the SB web BASICS ( with and without friends ) and general BASICS interventions were not effective at reducing SB drinking , results indicated significant intervention effects for SB in-person BASICS in reducing SB drinking , particularly on trip days .
RESULTS	Follow-up analyses indicated that change in descriptive norms mediated treatment effect and reductions in drinking , whereas SB drinking intentions and positive expectancies did not .
CONCLUSIONS	Overall , results suggest that an in-person SB-specific intervention is effective at reducing SB drinking , especially during trips .
CONCLUSIONS	In contrast , interventions that contain non-SB-related content , are web-based , or seek to involve friends may be less effective at reducing SB drinking .

###25097091
OBJECTIVE	This study aimed to improve our understanding of static and dynamic lower extremity sensory perception and the impact of sensory impairments on the control of walking in stroke survivors .
METHODS	Using a custom , real-time unloading system , we tested load perception at heel strike , mid stance and push off in 10 stroke survivors and compared their performance to 10 age-matched and 5 young adult control subjects .
METHODS	Dynamic load perception was based on a judgment of which leg was bearing more load , which was altered on a step by step basis .
METHODS	We also examined lower extremity static load perception , coordination , proprioception , balance , and gait symmetry .
RESULTS	The stroke survivors performed significantly worse than the control subjects in dynamic load perception , coordination , proprioception , balance and gait symmetry .
RESULTS	Gait symmetry correlated with static and dynamic load perception measures but not with age , proprioception , coordination , and balance .
CONCLUSIONS	Sensory deficits related to load detection in the impaired limb could result in an increased uncertainty of limb load and a gait strategy in which stroke survivors minimize loading of the impaired limb .
CONCLUSIONS	This new method of measuring lower extremity dynamic load perception provides a framework for understanding gait-related sensory impairments in stroke survivors .

###24326928
OBJECTIVE	To investigate the impact of respiratory muscle endurance training ( RMET ) on lung function and exercise performance in athletes with high lesion level paraplegia .
METHODS	This was a case-control intervention study .
METHODS	Sport and exercise science laboratories and bike path .
METHODS	Twelve competitive handbike athletes with high lesion level paraplegia matched by lesion and fitness level in training ( T ) group ( 7 ) and control ( C ) group ( 5 ) .
METHODS	The T group performed 20 RMET training sessions over a 4-week period using a SpiroTiger .
METHODS	Each session lasted for 30 minutes .
METHODS	The C group did not perform any RMET .
METHODS	Resting lung function , respiratory muscle endurance , and exercise performance ( arm cranking maximal incremental test and simulated handbike time trial ) .
RESULTS	Resting lung function was not different between groups and did not change with the intervention .
RESULTS	After RMET , the respiratory muscle endurance was significantly increased by 27 % in the T group but did not alter in the C group .
RESULTS	Final minute ventilation was increased from 89 20 L/min to 112 20 L/min after RMET in the T group and the sensation of dyspnea decreased ( P < 0.05 ) .
RESULTS	Peak oxygen consumption , peak mechanical power output , and handbike time trial performance were not different between groups and did not change with the RMET intervention .
CONCLUSIONS	A short-term RMET intervention in handbike athletes with high lesion level paraplegia improved respiratory muscle endurance but had little impact on overall exercise performance .

###24965957
OBJECTIVE	To assess the effectiveness of pilates method on patients with chronic non-specific low back pain ( LBP ) .
METHODS	A randomized controlled trial was carried out in sixty patients with a diagnosis of chronic non-specific LBP .
METHODS	Patients were randomly assigned to one of two groups : Experimental Group ( EG ) that maintained medication treatment with use of NSAID and underwent treatment with the pilates method and Control Group ( CG ) that continue medication treatment with use of NSAID and did not undergo any other intervention .
METHODS	A blinded assessor performed all evaluations at baseline ( T0 ) , after 45 , 90 , and 180 days ( T45 , T90 and T180 ) for : pain ( VAS ) , function ( Roland Morris questionnaire ) , quality of life ( SF-36 ) , satisfaction with treatment ( Likert scale ) , flexibility ( sit and reach test ) and NSAID intake .
RESULTS	The groups were homogeneous at baseline .
RESULTS	Statistical differences favoring the EG were found with regard to pain ( P < 0.001 ) , function ( P < 0.001 ) and the quality of life domains of functional capacity ( P < 0.046 ) , pain ( P < 0.010 ) and vitality ( P < 0.029 ) .
RESULTS	Statistical differences were also found between groups regarding the use of pain medication at T45 , T90 and T180 ( P < 0.010 ) , with the EG taking fewer NSAIDs than the CG .
CONCLUSIONS	The pilates method can be used by patients with LBP to improve pain , function and aspects related to quality of life ( functional capacity , pain and vitality ) .
CONCLUSIONS	Moreover , this method has no harmful effects on such patients .

###25391194
BACKGROUND	Obese children tend to consume less dietary folate , which is an important cofactor in remethylation of homocysteine to methionine .
BACKGROUND	The deficiency of folate can lead to hyperhomocysteinemia .
OBJECTIVE	To determine whether folic acid supplementation could reduce plasma homocysteine in obese children .
METHODS	Obese children , aged 9-15 years with body mass index > median plus 2 SD according to WHO reference , were randomly assigned to 2 groups : receiving either 5 mg folic acid or placebo for 2 months .
METHODS	Fasting homocysteine , creatinine , folate , vitamin B12 , insulin , glucose and lipid profiles were taken at baseline and the end of the study .
METHODS	Dietary vitamin B12 , folate intake and physical activity were assessed using validated questionnaires .
RESULTS	Fifty obese children ( 31 boys and 19 girls ) took part in the study .
RESULTS	Their mean age was 10.9 1.6 years and mean BMI Z-score was 3.41 0.69 .
RESULTS	After the intervention , plasma homocysteine decreased by 15.75 % and 6.99 % in the folic acid and placebo group , respectively ( mean difference 8.76 % ; 95 % CI : 0.26 % , 17.25 % , p = 0.044 ) .
RESULTS	This divergence was more pronounced in boys and it remained significant after adjusting for baseline homocysteine and other confounders .
RESULTS	Subgroup analysis showed a larger magnitude of plasma homocysteine reduction in the low folate group ( mean difference 12.24 % ; 95 % CI : 1.39 % , 23.09 % ) .
CONCLUSIONS	The homocysteine lowering effect of folic acid supplementation was found in obese children , especially in boys and those with low serum folate .
CONCLUSIONS	Further long-term interventional studies are needed to determine the effects of the lowered plasma homocysteine on the cardiovascular outcomes of obese children .
CONCLUSIONS	This trial was registered on clinicaltrials.gov ( NCT01766310 ) .

###25436480
OBJECTIVE	The purpose of this study was to evaluate whether simple bone cysts ( SBC ) resolve with age .
METHODS	Twenty four subjects with SBC who participated in a prior randomized clinical trial but had not healed at trial conclusion were evaluated for cyst healing .
METHODS	The following clinical and radiographic data were evaluated : age , sex , pain ( Visual Analogue Scale ) , functional health ( Short Form 36 ) , subsequent fracture , involved bone , cyst area ( cm ) , distance from physis ( cm ) , endosteal thickening ( yes/no ) , scalloping ( no new scalloping/new scalloping ) , opacity/radiolucency ( as is ) , loculation ( yes/no ) , trabeculation ( yes/no ) , tubulation ( yes/no ) , transition zone ( sharp/wide ) , geographic borders ( geographic nonpermeative/nongeographic permeative ) , radiodense rim ( > 50 % / no rim ) , and growth plate status ( open/closed ) .
METHODS	Cyst healing was graded as : 1-cyst clearly visible ; 2-cyst visible but multilocular and opaque ; 3-sclerosis around or within a partially visible cyst ; or 4-complete healing with obliteration of cyst .
METHODS	Healing was defined as grade 4 .
RESULTS	Of 24 subjects , 15 ( 63 % ) were male , 18 ( 75 % ) cysts were located in the humerus , and 4 ( 25 % ) in the femur .
RESULTS	Patients were followed for 7.01.0 years following initial treatment with a mean age at follow-up of 17.23.2 years and 14 ( 87 % ) of growth plates were closed .
RESULTS	Pain was minimal ( 0.6 / 10 ) , function was high ( 91/100 ) , and none of the patients had experienced subsequent fractures .
RESULTS	Although distance from physeal scar had increased ( P < 0.0001 ) , cyst area reduction ( P < 0.1 ) and overall cyst healing ( P < 0.2 ) had not changed .
RESULTS	Of the 24 subjects , none were graded as healed at time of follow-up .
RESULTS	Of the remaining radiographic variables , only decreased loculation ( P < 0.02 ) and increased endosteal thickening ( P < 0.04 ) showed significant changes .
CONCLUSIONS	Despite the assumption that most SBC will resolve with skeletal maturity , this study indicates that none of the cysts were graded as completely healed although 87 % of growth plates were closed .
CONCLUSIONS	Growth plate closure may not signify healing of SBC and although symptoms and fractures are rare , further studies are needed to follow patients with SBC through early adulthood .

###24731674
BACKGROUND	Lifestyle interventions among people with impaired glucose tolerance reduce the incidence of diabetes , but their effect on all-cause and cardiovascular disease mortality is unclear .
BACKGROUND	We assessed the long-term effect of lifestyle intervention on long-term outcomes among adults with impaired glucose tolerance who participated in the Da Qing Diabetes Prevention Study .
METHODS	The study was a cluster randomised trial in which 33 clinics in Da Qing , China-serving 577 adults with impaired glucose tolerance-were randomised ( 1:1:1:1 ) to a control group or lifestyle intervention groups ( diet or exercise or both ) .
METHODS	Patients were enrolled in 1986 and the intervention phase lasted for 6 years .
METHODS	In 2009 , we followed up participants to assess the primary outcomes of cardiovascular mortality , all-cause mortality , and incidence of diabetes in the intention-to-treat population .
RESULTS	Of the 577 patients , 439 were assigned to the intervention group and 138 were assigned to the control group ( one refused baseline examination ) .
RESULTS	542 ( 94 % ) of 576 participants had complete data for mortality and 568 ( 99 % ) contributed data to the analysis .
RESULTS	174 participants died during the 23 years of follow-up ( 121 in the intervention group vs 53 in the control group ) .
RESULTS	Cumulative incidence of cardiovascular disease mortality was 11.9 % ( 95 % CI 8.8-15 .0 ) in the intervention group versus 19.6 % ( 12.9-26 .3 ) in the control group ( hazard ratio [ HR ] 0.59 , 95 % CI 0.36-0 .96 ; p = 0.033 ) .
RESULTS	All-cause mortality was 28.1 % ( 95 % CI 23.9-32 .4 ) versus 38.4 % ( 30.3-46 .5 ; HR 0.71 , 95 % CI 0.51-0 .99 ; p = 0.049 ) .
RESULTS	Incidence of diabetes was 72.6 % ( 68.4-76 .8 ) versus 89.9 % ( 84.9-94 .9 ; HR 0.55 , 95 % CI 0.40-0 .76 ; p = 0.001 ) .
CONCLUSIONS	A 6-year lifestyle intervention programme for Chinese people with impaired glucose tolerance can reduce incidence of cardiovascular and all-cause mortality and diabetes .
CONCLUSIONS	These findings emphasise the long-term clinical benefits of lifestyle intervention for patients with impaired glucose tolerance and provide further justification for adoption of lifestyle interventions as public health measures to control the consequences of diabetes .
BACKGROUND	Centers for Disease Control and Prevention , WHO , the China-Japan Friendship Hospital , Da Qing First Hospital .

###26016859
BACKGROUND	To our knowledge , prior research has not examined the effects of magnesium supplementation on metabolic status and pregnancy outcomes in maternal-child dyads affected by gestational diabetes ( GDM ) .
OBJECTIVE	This study was designed to assess the effects of magnesium supplementation on metabolic status and pregnancy outcomes in magnesium-deficient pregnant women with GDM .
METHODS	A randomized , double-blind , placebo-controlled clinical trial was performed in 70 women with GDM .
METHODS	Patients were randomly assigned to receive either 250 mg magnesium oxide ( n = 35 ) or a placebo ( n = 35 ) for 6 wk .
METHODS	Fasting blood samples were taken at baseline and after a 6-wk intervention .
RESULTS	The change in serum magnesium concentration was greater in women consuming magnesium than in the placebo group ( +0.06 0.3 vs. -0.1 0.3 mg/dL , P = 0.02 ) .
RESULTS	However , after controlling for baseline magnesium concentrations , the changes in serum magnesium concentrations were not significantly different between the groups .
RESULTS	Changes in fasting plasma glucose ( -9.7 10.1 vs. +1.8 8.1 mg/dL , P < 0.001 ) , serum insulin concentration ( -2.1 6.5 vs. +5.7 10.7 IU/mL , P = 0.001 ) , homeostasis model of assessment-estimated insulin resistance ( -0.5 1.3 vs. +1.4 2.3 , P < 0.001 ) , homeostasis model of assessment-estimated - cell function ( -4.0 28.7 vs. +22.0 43.8 , P = 0.006 ) , and the quantitative insulin sensitivity check index ( +0.004 0.021 vs. -0.012 0.015 , P = 0.005 ) in supplemented women were significantly different from those in women in the placebo group .
RESULTS	Changes in serum triglycerides ( +2.1 63.0 vs. +38.9 37.5 mg/dL , P = 0.005 ) , high sensitivity C-reactive protein ( -432.8 2521.0 vs. +783.2 2470.1 ng/mL , P = 0.03 ) , and plasma malondialdehyde concentrations ( -0.5 1.6 vs. +0.3 1.2 mol/L , P = 0.01 ) were significantly different between the supplemented women and placebo group .
RESULTS	Magnesium supplementation resulted in a lower incidence of newborn hyperbilirubinemia ( 8.8 % vs. 29.4 % , P = 0.03 ) and newborn hospitalization ( 5.9 % vs. 26.5 % , P = 0.02 ) .
CONCLUSIONS	Magnesium supplementation among women with GDM had beneficial effects on metabolic status and pregnancy outcomes .
CONCLUSIONS	This trial was registered at www.irct.ir as IRCT201503055623N39 .

###24757674
BACKGROUND	Physical performances and cognition are positively related in cognitively healthy people .
BACKGROUND	The aim of this study was to examine whether physical performances are related to specific cognitive functioning in older people with mild to severe cognitive impairment .
METHODS	This cross-sectional study included 134 people with a mild to severe cognitive impairment ( mean age 82 years ) .
METHODS	Multiple linear regression was performed , after controlling for covariates and the level of global cognition , with the performances on mobility , strength , aerobic fitness , and balance as predictors and working memory and episodic memory as dependent variables .
RESULTS	The full models explain 49-57 % of the variance in working memory and 40-43 % of episodic memory .
RESULTS	Strength , aerobic fitness , and balance are significantly associated with working memory , explaining 3-7 % of its variance , irrespective of the severity of the cognitive impairment .
RESULTS	Physical performance is not related to episodic memory in older people with mild to severe cognitive impairment .
CONCLUSIONS	Physical performance is associated with working memory in older people with cognitive impairment .
CONCLUSIONS	Future studies should investigate whether physical exercise for increased physical performance can improve cognitive functioning .
CONCLUSIONS	This trial is registered with ClinicalTrials.gov NTR1482 .

###24658550
OBJECTIVE	Different types of modified ultrafiltration ( MUF ) systems evaluated showed that none of the MUF techniques adhered to the normal venous to arterial blood flow dynamics .
OBJECTIVE	This study compared a conventional arteriovenous modified ultrafiltration ( AVMUF ) system to a custom - designed venoarterial modified ultrafiltration ( VAMUF ) system .
METHODS	Randomized , controlled clinical study conducted at the Northwest Armed Forces Military hospital in Tabuk , Saudi Arabia .
METHODS	Sixty patients who underwent MUF during the years 2007 and 2009 were divided into 2 groups : the AVMUF ( n = 30 ) and the VAMUF ( n = 30 ) groups .
METHODS	MUF was performed for a mean time of 12 minutes in both groups .
METHODS	In AVMUF , blood was removed from the aorta , hemoconcentrated , and infused into the right atrium ( RA ) .
METHODS	In VAMUF , blood flow was from the RA through a hemoconcentrator and re-infused into the aorta .
RESULTS	Results of the study showed that the VAMUF group required a shorter ventilation time ( P < .001 ) , in.tensive care unit ( ICU ) ( P = .003 ) , and hospital stay ( P = .007 ) than the AVMUF group .
RESULTS	Results also demonstrated a lower percentage of fluid balance ( P = .008 ) in the VAMUF group .
RESULTS	The systolic ( P < .001 ) and mean blood pres.sures ( P < .001 ) were significantly higher after VAMUF , with a decrease in heart rate ( P < .001 ) and central venous pressure ( P = .002 ) .
RESULTS	The VAMUF group showed a significantly greater decrease of creatinine ( P < .001 ) , serum lactacte ( P < .001 ) , and uric acid ( P < .027 ) over time with no significant differences in oximetry .
CONCLUSIONS	Results prove that VAMUF is a more physiological technique than AVMUF .

###24996648
BACKGROUND	Interspinous spacers are a minimally invasive surgical alternative for patients with lumbar spinal stenosis ( LSS ) unresponsive to conservative care .
BACKGROUND	The purpose of this prospective , multicenter , randomized , controlled trial was to compare 2-year clinical outcomes in patients with moderate LSS treated with the Superion ( ) ( Experimental ) or the X-Stop ( ) , a FDA-approved interspinous spacer ( Control ) .
METHODS	A total of 250 patients with moderate LSS unresponsive to conservative care were randomly allocated to treatment with the Experimental ( n = 123 ) or Control ( n = 127 ) interspinous spacer and followed through 2 years post-treatment .
METHODS	Complication data were available for all patients and patient-reported outcomes were available for 192 patients ( 101 Experimental , 91 Control ) at 2 years .
RESULTS	Zurich Claudication Questionnaire ( ZCQ ) Symptom Severity and Physical Function scores improved 34 % to 36 % in both groups through 2 years ( all p < 0.001 ) .
RESULTS	Patient Satisfaction scores at 2 years were 1.8 0.9 with Experimental and 1.6 0.8 with Control .
RESULTS	Axial pain decreased from 59 26 mm at baseline to 21 26 mm at 2 years with Experimental and from 55 26 mm to 21 25 mm with Control ( both p < 0.001 ) .
RESULTS	Extremity pain decreased from 67 24 mm to 14 22 mm at 2 years with Experimental and from 63 24 mm to 18 23 mm with Control ( both p < 0.001 ) .
RESULTS	Back function assessed with the Oswestry Disability Index similarly improved with Experimental ( 37 12 % to 18 16 % ) and Control ( 39 12 % to 20 16 % ) ( both p < 0.001 ) .
RESULTS	Freedom from reoperation at the index level was 84 % for Experimental and 83 % for Control ( log-rank : p = 0.38 ) at 2 years .
CONCLUSIONS	Both interspinous spacers effectively alleviated pain and improved back function to a similar degree through 2 years in patients with moderate LSS who were unresponsive to conservative care .
BACKGROUND	NCT00692276 .

###26039952
OBJECTIVE	Sacrococcygeal pilonidal sinus is common in young men and may recur over time after surgery .
OBJECTIVE	We investigated whether a factor exists that can aid in the determination of the preferred technique between the early Limberg flap and Karydakis flap techniques for treating recurrent pilonidal sinus .
METHODS	This prospective and randomized study enrolled 71 patients with recurrent pilonidal sinus in whom the Limberg flap or Karydakis flap techniques were applied for reconstruction after excision .
METHODS	Patients were divided into two groups as follows : 37 patients were treated with the Limberg flap technique and 34 patients were treated with the Karydakis flap technique .
METHODS	Fluid collection , wound infection , flap edema , hematoma , partial wound separation , return to daily activities , pain score , complete healing time , painless seating and patient satisfaction were compared between the groups .
METHODS	ClinicalTrial.gov : NCT02287935 .
RESULTS	The development rates of total fluid collection , wound infection , flap edema , hematoma , and partial wound separation were 9.8 % , 16 % , 7 % , 15 % and 4.2 % , respectively ; total flap necrosis was not observed in any patient ( p < 0.001 ) .
RESULTS	During the average follow-up of 28 months , no patients ( 0 % ) developed recurrent disease .
RESULTS	The two groups differed with respect to early surgical complications ( p < 0.001 ) .
CONCLUSIONS	In this study , use of the Limberg flap was associated with lower complication rates , shorter length of hospital stay , early return to work , low pain score , high patient satisfaction and better complete healing duration .
CONCLUSIONS	Therefore , we recommend the Limberg flap for treatment of recurrent pilonidal sinus .

###24226495
BACKGROUND	Hyperbaric 2 % prilocaine produces a faster onset and shorter duration of spinal anesthesia than a plain solution .
BACKGROUND	The anesthetic profile could be improved by restricting the block to the operative side .
BACKGROUND	We compared unilateral versus conventional bilateral spinal anesthesia with hyperbaric 2 % prilocaine in day-case patients undergoing unilateral inguinal herniorrhaphy .
METHODS	Eighty patients were randomly assigned to receive either conventional bilateral ( N. = 40 ) or unilateral ( N. = 40 ) spinal anesthesia with 50 mg hyperbaric prilocaine 2 % .
METHODS	In the unilateral group , lateral decubitus was maintained for 10 minutes .
METHODS	Sensory and motor block courses , time to first micturition , and side effects were recorded .
RESULTS	On the operated side , the highest sensory block was T8 ( T12-T2 ) in the unilateral and T9 ( T11-T4 ) in the bilateral group ( P = 0.0328 ) ; the time to motor ( 115 26 min in the unilateral and 108 24 min in the bilateral groups , P = 0.2350 ) and sensory ( 156 30 min in the unilateral and 158 26 min in the bilateral groups , P = 0.7550 ) block resolution was similar in both groups .
RESULTS	On the non-operated side , the unilateral group had a faster motor ( 64 48 , P < 0.001 ) and sensory ( 120 47 , P < 0.001 ) time to block resolution than the conventional group .
RESULTS	Restricted unilateral motor and sensory block was achieved in 30 % and 12.5 % of patients , respectively .
RESULTS	Time to voiding was shorter in the unilateral than in the conventional group ( 220 47 vs. 249 51 min , respectively , P = 0.0104 ) .
RESULTS	There were no significant differences in adequacy for surgery and side effects between the groups .
CONCLUSIONS	In day-case inguinal herniorrhaphy , attempting unilateral spinal anesthesia with 50 mg hyperbaric 2 % prilocaine produced faster time to voiding .

###25484179
BACKGROUND	Eslicarbazepine acetate ( ESL ) is an anticonvulsant approved as an adjunctive therapy in adults with partial-onset seizures .
OBJECTIVE	To evaluate the efficacy , safety and tolerability of ESL in the treatment of acute mania and prevention of recurrence in bipolar disorder I.
METHODS	Two 3-week multicentre , double-blind , randomised , placebo-controlled studies in acute mania ( study BIA-2093-203 : dose titrated by response , ESL 600-1800mg or 800-2400mg , once-daily ; study BIA-2093-204 : fixed doses of 600 , 1200 and 1800mg , once-daily ) were followed by a recurrence prevention study consisting of a 2-week open-label period ( 900mg , once-daily ) continued by a double-blind , parallel-group , fixed dose ( 300 , 900 and 1800mg , once-daily ) period for a minimum of 6 months .
METHODS	The primary endpoint was changed from baseline until the end of the 3-week treatment period in Young Mania Rating Scale ( YMRS ) in studies BIA-2093-203 and BIA-2093-204 , and the proportion of patients showing no worsening according to the Clinical Global Impressions - Bipolar Version ( CGI-BP ) over Part II in study BIA-2093-205 .
RESULTS	In study BIA-2093-203 ( n = 160 , ITT ) , neither dose group was statistically different from placebo in the primary endpoint , though the ESL 800-2400mg showed a greater reduction in YMRS score ( p = 0.0523 ) .
RESULTS	CGI-BP score changes for mania and overall bipolar illness indicate a significant improvement in patient symptomatology for the ESL 800-2400mg group ( from preceding and worst phase ) and for ESL 600-1800mg group ( from worst phase only ) when compared to placebo .
RESULTS	Study BIA-2093-204 ( n = 38 ) results were inconclusive due to premature termination caused by recruitment difficulties .
RESULTS	In study BIA-2093-205 ( n = 85 , ITT ) , at least 50 % of patients showed no worsening in all treatment groups ( p = 0.250 ) .
RESULTS	ESL adverse events were mostly of mild and moderate intensities and consistent with previously reported observations for ESL .
CONCLUSIONS	ESL treatment was not significantly different from placebo in manic patients in the primary outcome , but secondary outcomes may be suggestive of efficacy .
CONCLUSIONS	The recurrence prevention study provides preliminary support for efficacy of ESL in patients recovered from an acute manic episode .

###25420793
BACKGROUND	A previously published proof of principle phase IIa trial with 113 patients from Kabul showed that bipolar high-frequency ( HF ) electro-cauterization ( EC ) of cutaneous leishmaniasis ( CL ) ulcers and subsequent moist wound treatment ( MWT ) closed 85 % of all Leishmania ( L. ) tropica lesions within 60days .
METHODS	A three-armed phase IIb , randomized and controlled clinical trial was performed in Mazar-e-Sharif .
METHODS	L. tropica - or L. major-infected CL patients received intradermal sodium stibogluconate ( SSG ) ( Group I ) ; HF-EC followed by MWT with 0.045 % DAC N-055 ( Group II ) ; or MWT with 0.045 % DAC N-055 in basic crme alone ( Group III ) .
METHODS	The primary outcome was complete epithelialisation before day 75 after treatment start .
RESULTS	87 patients enrolled in the trial were randomized into group I ( n = 24 ) , II ( n = 32 ) and III ( n = 31 ) .
RESULTS	The per-protocol analysis of 69 ( 79 % ) patients revealed complete epithelialisation before day 75 in 15 ( of 23 ; 65 % ) patients of Group I , in 23 ( of 23 ; 100 % ) patients of Group II , and in 20 ( of 23 ; 87 % ) patients of Group III ( p = 0.004 , Fisher 's Exact Test ) .
RESULTS	In the per-protocol analysis , wound closure times were significantly different between all regimens in a pair-wise comparison ( p = 0.000039 , Log-Rank ( Mantel-Cox ) test ) .
RESULTS	In the intention-to-treat analysis wound survival times in Group II were significantly different from those in Group I ( p = 0.000040 , Log-Rank ( Mantel-Cox ) test ) .
RESULTS	Re-ulcerations occurred in four ( 17 % ) , three ( 13 % ) and seven ( 30 % ) patients of Group I , II or III , respectively ( p = 0.312 , Pearson Chi-Square Test ) .
CONCLUSIONS	Treatment of CL ulcers with bipolar HF-EC followed by MWT with 0.045 % DAC N-055 or with DAC N-055 alone showed shorter wound closure times than with the standard SSG therapy .
CONCLUSIONS	The results merit further exploration in larger trials in the light of our current knowledge of in vitro and in vivo activities of chlorite .
CONCLUSIONS	Clinicaltrials.gov ID : NCT00996463 .
CONCLUSIONS	Registered : 15th October 2009 .

###24392996
BACKGROUND	The primary objective of this prospective controlled study was to investigate the impact of standardized injection-site warming on prandial rapid acting insulin dose and glycemic control when studied under real-world conditions .
METHODS	All 145 participating patients ( 51 female , 94 male , 13 type 1 and 132 type 2 patients , age : 61.68.4 yrs , HbA1c : 7.190.50 % ) were treated with intensive insulin glargine and short-acting insulin analog therapy .
METHODS	After a 4week treatment optimization run-in period , patients were randomized to continue therapy for three months without ( control ) or with a local injection-site warming device ( InsuPad * ) .
METHODS	Observation parameters included HbA1c , insulin dose , frequency of hypoglycemia , body weight and adverse events .
RESULTS	HbA1c improved in both arms until study end ( control group : 6.30.5 % ; injection-site warming device : 6.30.5 % ; both p < 0.001 vs. baseline ) .
RESULTS	To achieve this good control , patients in the control group needed to increase the daily prandial insulin dose by 8.1 % ( from 6631U to 7138U , p < 0.05 ) with stable basal insulin requirements .
RESULTS	Patients who used the injection-site warming device required less prandial insulin ( 7043U to 5534U ; -19 % , p < 0.001 ) and slightly more basal insulin ( +3.9 % ) .
RESULTS	Total daily insulin dose increased in the control group ( +3.7 % ) and decreased with warming device use ( -8.6 % , p < 0.001 ) .
RESULTS	The number of hypoglycemic events ( < 63mg/dL ) during the observation period was higher in the control group ( 6.29.9 / patient vs. injection-site warming device : 3.34.8 / patient , p < 0.05 ) .
RESULTS	Main study limitations can be seen in the open label design reliability of the collected dose information and the very obese patient cohort .
CONCLUSIONS	When treating obese patients to target with insulin therapy , use of an injection-site warming device for 3months resulted in a lower frequency of hypoglycemic events and a reduction in prandial insulin analog requirements .
CONCLUSIONS	If these results are confirmed in other patient populations , an injection-site warming device may be useful in achieving treatment targets with a safer and more efficient basal bolus therapy in insulin-treated patients with type 1 and type 2 diabetes .

###25229605
OBJECTIVE	To examine whether an acute bout of active or dynamic hamstring-stretching exercises would reduce the amount of muscle damage observed after a strenuous eccentric task and to determine whether the stretching protocols elicit similar responses .
METHODS	A randomized controlled clinical trial .
METHODS	Thirty-six young male students performed 5 min of jogging as a warm-up and were allocated to 1 of 3 groups : 3 min of static active stretching ( SAS ) , 3 min of dynamic active stretching ( DAS ) , or control ( CON ) .
METHODS	All subjects performed eccentric exercise immediately after stretching .
METHODS	Heart rate , core temperature , maximal voluntary isometric contraction , passive hip flexion , passive hamstring stiffness ( PHS ) , plasma creatine kinase activity , and myoglobin were recorded at prestretching , at poststretching , and every day after the eccentric exercises for 5 d.
RESULTS	After stretching , the change in hip flexion was significantly higher in the SAS ( 5 ) and DAS ( 10.8 ) groups than in the CON ( -4.1 ) group .
RESULTS	The change in PHS was significantly higher in the DAS ( 5.6 % ) group than in the CON ( -5.7 % ) and SAS ( -6.7 % ) groups .
RESULTS	Furthermore , changes in muscle-damage markers were smaller in the SAS group than in the DAS and CON groups .
CONCLUSIONS	Prior active stretching could be useful for attenuating the symptoms of muscle damage after eccentric exercise .
CONCLUSIONS	SAS is recommended over DAS as a stretching protocol in terms of strength , hamstring range of motion , and damage markers .

###25202885
OBJECTIVE	To develop and validate a predictive model for glucose change and risk for new-onset impaired fasting glucose in hypertensive participants following treatment with atenolol or hydrochlorothiazide ( HCTZ ) .
METHODS	Randomized multicenter clinical trial .
METHODS	A total of 735 white or African-American men and women with uncomplicated hypertension .
RESULTS	Pharmacogenomic Evaluation of Antihypertensive Responses ( PEAR ) is a randomized clinical trial to assess the genetic and nongenetic predictors of blood pressure response and adverse metabolic effects following treatment with atenolol or HCTZ .
RESULTS	To develop and validate predictive models for glucose change , PEAR participants were randomly divided into a derivation cohort of 367 and a validation cohort of 368 .
RESULTS	Linear and logistic regression modeling were used to build models of drug-associated glucose change and impaired fasting glucose ( IFG ) , respectively , in the derivation cohorts .
RESULTS	These models were then evaluated in the validation cohorts .
RESULTS	For glucose change after atenolol or HCTZ treatment , baseline glucose was a significant ( p < 0.0001 ) predictor , explaining 13 % of the variability in glucose change after atenolol and 12 % of the variability in glucose change after HCTZ .
RESULTS	Baseline glucose was also the strongest and most consistent predictor ( p < 0.0001 ) for development of IFG after atenolol or HCTZ monotherapy .
RESULTS	The area under the receiver operating curve was 0.77 for IFG after atenolol and 0.71 after HCTZ treatment , respectively .
CONCLUSIONS	Baseline glucose is the primary predictor of atenolol or HCTZ-associated glucose increase and development of IFG after treatment with either drug .

###25447748
OBJECTIVE	To compare the benefits of a thermal cure and non-thermal rehabilitation in treatment of knee osteoarthritis ( KOA ) .
METHODS	Randomized therapeutic trial including patients with knee osteoarthritis ( American College of Rheumatology criteria ) .
METHODS	Patients were randomly divided into two groups .
METHODS	Spa treatment consisted of underwater shower , massage-jet showers , hydromassage , pool rehabilitation and peloid therapy .
METHODS	Non-thermal rehabilitation consisted of analgesic physiotherapy , muscle strengthening and group physical rehabilitation .
METHODS	A blinded evaluation was carried out at day 21 and 12months following treatment .
METHODS	It was based on the visual analogic scale of pain ( VAS ) , which represented the primary endpoint .
RESULTS	Two hundred and forty patients were included ( February-June 2005 ) .
RESULTS	The spa treatment and non-thermal rehabilitation groups included 119 and 121patients respectively .
RESULTS	Two hundred and thirty-three patients completed their treatments .
RESULTS	Significant improvement of the visual analogic scale of pain was noted in the thermal cure group ( 61.615 at day 0 versus 46.522.4 at 12months , P < 0.001 ) , but not in the non-thermal group ( 64.115 at day 0 versus 6229 at 12months , P = 0.68 ) .
RESULTS	At day 21 , comparison of the two groups revealed no significant difference on the VAS ( P = 0.08 ) .
RESULTS	However , at 12months , the thermal cure group was significantly more improved ( P = 0.000 ) .
CONCLUSIONS	In our study , crenobalneotherapy had resulted , at 12months , in more pronounced long-term improvement of the painful symptoms of KOA than had non-thermal rehabilitation .

###25281992
OBJECTIVE	To assess the effects of maintenance therapy with aripiprazole once-monthly 400mg on personal and social functioning .
METHODS	Data were analyzed from 2 randomized , double-blind trials of patients with schizophrenia requiring chronic antipsychotic treatment .
METHODS	One study was a 52-week trial of aripiprazole once-monthly 400mg versus placebo ; the other was a 38-week trial of aripiprazole once-monthly 400mg , oral aripiprazole ( 10-30 mg daily ) , and aripiprazole once-monthly 50mg ( subtherapeutic dose to test assay sensitivity ) .
METHODS	Functioning was assessed using the Personal and Social Performance ( PSP ) scale , comprising 4 domain subscales .
RESULTS	In the 52-week study , 403 patients stabilized on aripiprazole once-monthly 400mg were randomized to receive aripiprazole once-monthly 400mg ( n = 269 ) or placebo ( n = 134 ) .
RESULTS	In the 38-week study , 662 patients stabilized on oral aripiprazole were randomized to receive aripiprazole once-monthly 400mg ( n = 265 ) , oral aripiprazole ( n = 266 ) , or aripiprazole once-monthly 50mg ( subtherapeutic dose ; n = 131 ) .
RESULTS	In the 52-week study , mean changes from baseline were significantly worsened with placebo compared with aripiprazole once-monthly 400mg for PSP total score ( P < 0.001 ) and domain scores for Personal and Social Relationships ( P < 0.001 ) , Self-Care ( P < 0.01 ) , and Disturbing and Aggressive Behavior ( P < 0.0001 ) .
RESULTS	In the 38-week study , mean changes from baseline were significantly worsened with aripiprazole once-monthly 50mg compared with aripiprazole once-monthly 400mg for PSP total score ( P < 0.05 ) and the Personal and Social Relationships domain score ( P < 0.05 ) .
CONCLUSIONS	Patient functioning , assessed using the PSP scale , was maintained in stabilized patients treated with aripiprazole once-monthly in 2 pivotal relapse studies .

###24862240
OBJECTIVE	To ( 1 ) determine diabetes patients ' acceptance of Internet-based interventions ( IBIs ) for depression , to ( 2 ) examine the effectiveness of an acceptance facilitating intervention ( AFI ) and to ( 3 ) explore subgroup specific effects .
METHODS	141 diabetes patients from two inpatient rehabilitation units and one outpatient clinic in Germany were randomly allocated to an intervention ( IG ) and a no-intervention control group ( CG ) .
METHODS	The IG received an AFI consisting of a personal information session before filling-out a questionnaire on patients ' acceptance of IBIs , predictors of acceptance ( performance expectancy , effort expectancy , social influence , facilitating conditions , and Internet anxiety ) as well as sociodemographic , depression-related and diabetes-related variables .
METHODS	The CG filled out the questionnaire immediately .
METHODS	Patients ' acceptance of IBIs was measured with a four-item scale ( sum-score ranging from 4 to 20 ) .
RESULTS	The CG showed a low ( 50.7 % ) to medium ( 40.8 % ) acceptance with only 8.5 % of all diabetes patients reporting a high acceptance of IBIs for depression .
RESULTS	The AFI had no significant effect on acceptance ( IG : M = 10.55 , SD = 4.69 , n = 70 ; KG : M = 9.65 , SD = 4.27 , n = 71 ; d = 0.20 [ 95 % - CI : -0.13 ; 0.53 ] ) and the predictors of acceptance .
RESULTS	Yet , subgroup analyses yielded a trend for depressed , diabetes-related distressed , female and younger ( < 59 ) participants and for those who do not frequently use the Internet to profit from the AFI .
CONCLUSIONS	Diabetes patients show a rather low acceptance toward IBIs for depression .
CONCLUSIONS	Findings indicate that the AFI is likely to be effective in the subgroup of depressed , diabetes-related distressed , female or younger diabetes patients , but not in the whole target population .
CONCLUSIONS	Hence , AFIs might need to be tailored to the specific needs of subpopulations .

###24366788
OBJECTIVE	To compare the use of ropivacaine versus bupivacaine for 3-in-1 block during total knee arthroplasty ( TKA ) in terms of efficacy and safety ( lack of toxicity ) .
METHODS	14 men and 26 women aged 58 to 77 ( median , 70 ) years who had the American Society of Anesthesiologists ( ASA ) grades I to III physical status were randomised to receive ropivacaine ( n = 20 ) or bupivacaine ( n = 20 ) of a concentration of 0.5 % for 3-in-1 block during TKA .
METHODS	The dosage was 0.5 ml/kg .
METHODS	In addition , a sciatic nerve block ( 20 ml of prilocaine 1 % ) was used .
METHODS	The onset of the block , duration of postoperative analgesia , level of motor block , and any side-effects were compared .
RESULTS	The median time to onset of block was significantly shorter in those receiving ropivacaine than bupivacaine ( 13 vs. 17.5 minutes , p < 0.001 ) , but the levels of motor blockade were not significantly different ( p = 0.355 ) .
RESULTS	Complete analgesia was achieved throughout the procedure .
RESULTS	There was no significant difference between the ropivacaine and bupivacaine groups in terms of the mean duration of analgesia ( 398 vs. 367 minutes , p = 0.62 ) , the mean VAS scores at all time points , and the mean total morphine consumption .
RESULTS	One patient in the ropivacaine group developed a joint haematoma and 2 patients in the bupivacaine group had excessive wound drainage .
RESULTS	Both conditions resolved after antibiotic use .
CONCLUSIONS	Ropivacaine and bupivacaine showed similar anesthetic and analgesic effects , but the former had a significantly faster onset time .

###24996511
BACKGROUND	Many of the approximately 15 million people with a migration background living in Germany ( 19 % of the population ) are inadequately reached by existing healthcare provision .
BACKGROUND	In the literature , the necessity for cultural adaptation of information material for patients with a migration background is often cited as a measure for improving healthcare.In this study , culturally sensitive information material will be developed and evaluated for patients with a migration background and depression or chronic low back pain .
BACKGROUND	In this respect , it will be examined whether culturally sensitive information material is judged as more useful by the patients than standard translated patient information without cultural adaptation .
METHODS	The implementation and evaluation of culturally sensitive patient information material will occur in the framework of a double-blind randomized controlled parallel-group study in four study centres in Germany .
METHODS	Primary care patients with a Turkish , Polish , Russian or Italian migration background with a diagnosis of depressive disorder or chronic low back pain will be included and randomly allocated to the intervention group or the control group .
METHODS	In the intervention group , culturally sensitive patient information will be handed to the patient at the end of the physician consultation , while in the control group , standard translated patient information material will be provided .
METHODS	The patients will be surveyed by means of questionnaires following the consultation as well as after 8weeks and 6months .
METHODS	In addition to the primary outcome ( subjective usefulness ) , several patient - and physician-rated secondary outcomes will be considered .
CONCLUSIONS	The study will provide an empirical answer to the question of whether persons with a migration background perceive culturally sensitive patient information material as more useful than translated information material without cultural adaptation .
BACKGROUND	Deutsches Register Klinischer Studien ( DRKS-ID ) DRKS00004241 and Universal Trial Number ( UTN ) U1111-1135-8043 .

###26323938
BACKGROUND	Central sleep apnea is associated with poor prognosis and death in patients with heart failure .
BACKGROUND	Adaptive servo-ventilation is a therapy that uses a noninvasive ventilator to treat central sleep apnea by delivering servo-controlled inspiratory pressure support on top of expiratory positive airway pressure .
BACKGROUND	We investigated the effects of adaptive servo-ventilation in patients who had heart failure with reduced ejection fraction and predominantly central sleep apnea .
METHODS	We randomly assigned 1325 patients with a left ventricular ejection fraction of 45 % or less , an apnea-hypopnea index ( AHI ) of 15 or more events ( occurrences of apnea or hypopnea ) per hour , and a predominance of central events to receive guideline-based medical treatment with adaptive servo-ventilation or guideline-based medical treatment alone ( control ) .
METHODS	The primary end point in the time-to-event analysis was the first event of death from any cause , lifesaving cardiovascular intervention ( cardiac transplantation , implantation of a ventricular assist device , resuscitation after sudden cardiac arrest , or appropriate lifesaving shock ) , or unplanned hospitalization for worsening heart failure .
RESULTS	In the adaptive servo-ventilation group , the mean AHI at 12 months was 6.6 events per hour .
RESULTS	The incidence of the primary end point did not differ significantly between the adaptive servo-ventilation group and the control group ( 54.1 % and 50.8 % , respectively ; hazard ratio , 1.13 ; 95 % confidence interval [ CI ] , 0.97 to 1.31 ; P = 0.10 ) .
RESULTS	All-cause mortality and cardiovascular mortality were significantly higher in the adaptive servo-ventilation group than in the control group ( hazard ratio for death from any cause , 1.28 ; 95 % CI , 1.06 to 1.55 ; P = 0.01 ; and hazard ratio for cardiovascular death , 1.34 ; 95 % CI , 1.09 to 1.65 ; P = 0.006 ) .
CONCLUSIONS	Adaptive servo-ventilation had no significant effect on the primary end point in patients who had heart failure with reduced ejection fraction and predominantly central sleep apnea , but all-cause and cardiovascular mortality were both increased with this therapy .
CONCLUSIONS	( Funded by ResMed and others ; SERVE-HF ClinicalTrials.gov number , NCT00733343 . )

###24646311
OBJECTIVE	To determine if the presence of diabetes autoantibodies predicts the development of diabetes among participants in the Diabetes Prevention Program .
METHODS	A total of 3050 participants were randomized into three treatment groups : intensive lifestyle intervention , metformin and placebo .
METHODS	Glutamic acid decarboxylase ( GAD ) 65 autoantibodies and insulinoma-associated-2 autoantibodies were measured at baseline and participants were followed for 3.2 years for the development of diabetes .
RESULTS	The overall prevalence of GAD autoantibodies was 4.0 % , and it varied across racial/ethnic groups from 2.4 % among Asian-Pacific Islanders to 7.0 % among non-Hispanic black people .
RESULTS	There were no significant differences in BMI or metabolic variables ( glucose , insulin , HbA ( 1c ) , estimated insulin resistance , corrected insulin response ) stratified by baseline GAD antibody status .
RESULTS	GAD autoantibody positivity did not predict diabetes overall ( adjusted hazard ratio 0.98 ; 95 % CI 0.56-1 .73 ) or in any of the three treatment groups .
RESULTS	Insulinoma-associated-2 autoantibodies were positive in only one participant ( 0.033 % ) .
CONCLUSIONS	These data suggest that ` diabetes autoimmunity ' , as reflected by GAD antibodies and insulinoma-associated-2 autoantibodies , in middle-aged individuals at risk for diabetes is not a clinically relevant risk factor for progression to diabetes .

###24675714
BACKGROUND	A high dietary protein ( P ) content and low glycemic index ( LGI ) have been suggested to be beneficial for weight management , but long-term studies are scarce .
OBJECTIVE	The DIOGENES randomized clinical trial investigated the effect of P and GI on weight loss maintenance in overweight or obese adults in eight centers across Europe .
OBJECTIVE	This study reports the 1-year results in two of the centers that extended the intervention to 1 year .
METHODS	After an 8-week low-calorie diet ( LCD ) , 256 adults ( body mass index > 27kgm ( - ) ( 2 ) ) were randomized to five ad libitum diets for 12 months : high P/LGI ( HP/LGI ) , HP/high GI ( HP/HGI ) , low P/LGI ( LP/LGI ) , LP/HGI and a control diet .
METHODS	During the first 6 months , foods were provided for free through a shop system and during the whole 12-month period , subjects received guidance by a dietician .
METHODS	Primary outcome variable was the change in body weight over the 12-month intervention period .
RESULTS	During the LCD period , subjects lost 11.2 ( 10.8 , 12.0 ) kg ( mean ( 95 % confidence interval ( CI ) ) ) .
RESULTS	Average weight regain over the 12-month intervention period was 3.9 ( 95 % CI 3.0-4 .8 ) kg .
RESULTS	Subjects on the HP diets regained less weight than subjects on the LP diets .
RESULTS	The difference in weight regain after 1 year was 2.0 ( 0.4 , 3.6 ) kg ( P = 0.017 ) ( completers analysis , N = 139 ) or 2.8 ( 1.4 , 4.1 ) kg ( P < 0.001 ) ( intention-to-treat analysis , N = 256 ) .
RESULTS	No consistent effect of GI on weight regain was found .
RESULTS	There were no clinically relevant differences in changes in cardiometabolic risk factors among diet groups .
CONCLUSIONS	A higher protein content of an ad libitum diet improves weight loss maintenance in overweight and obese adults over 12 months .

###24626975
OBJECTIVE	To verify the effectiveness of the Cognitive Auditory Evoked Potential-P300 ( CAEP-P300 ) for monitoring the therapeutical evolution of students with developmental dyslexia .
METHODS	Twenty students diagnosed with developmental dyslexia , of both genders , aged between 8 and 14 years , divided into two randomized groups , one of them submitted to a phonological remediation program associated with reading and writing ( GI ) , and the other one representing the control group ( GII ) , participated in the study .
METHODS	The groups were paired up , and the individuals were submitted to two evaluations of the CAEP-P300 and the same interval was kept for both .
METHODS	Paired Student 's t-test , ANOVA test , and Pearson 's correlation coefficient were used , adopting 5 % significance level .
RESULTS	The statistical comparison of the pre and post evaluations of each group demonstrated difference in the Phonological Awareness Test ( p = 0.000 ) and in the P300 latency ( p = 0.005 ) only for GI .
CONCLUSIONS	CAEP-P300 use for monitoring the therapeutical evolution of children with developmental dyslexia is possible and represents a viable option for intervention programs .

###25514700
OBJECTIVE	The aim of this study was to evaluate the effectiveness of punctal occlusion using hypromellose 2 % in patients with dry eye .
METHODS	In this prospective , randomized single-blinded clinical trial , we evaluated 76 eyes of 38 patients ( 36 women and 2 men ) with dry eye secondary to rheumatic diseases .
METHODS	In each patient , the lower lacrimal punctum of 1 eye was occluded using hypromellose 2 % , whereas the contralateral eye underwent a simulation of the procedure ( control group ) .
METHODS	Patients ' eyes were assessed for burning , itching , redness , foreign body sensation , and tearing based on a visual scale questionnaire ( score , 0-10 ) .
METHODS	We also performed objective tests for evaluation of dry eye using a Schirmer test with anesthesia ( basal tear secretion test ) , the tear film break-up time test , and fluorescein and rose bengal staining tests at 0 , 28 , and 56 days after treatment .
RESULTS	Fluorescein and rose bengal staining tests showed that there was a significant reduction in signs after occlusion using hypromellose .
RESULTS	The symptoms measured by the visual scale were significantly reduced .
RESULTS	The values of the Schirmer test with anesthesia and the break-up time test increased significantly .
RESULTS	The effects persisted for up to 8 weeks .
RESULTS	There were no dropouts or reported side effects during the 24-month follow-up .
CONCLUSIONS	Our results suggest that punctal occlusion using hypromellose 2 % is a low-cost and safe additional treatment for dry eye .

###25065540
BACKGROUND	Systemic inflammation plays an important role in the initiation , promotion , and progression of lung carcinogenesis .
BACKGROUND	In patients with non-small cell lung cancer ( NSCLC ) , fibrinogen levels correlate with neoplasia .
BACKGROUND	Here we compared the effects of pulmonary rehabilitation ( PR ) with chest physical therapy ( CPT ) on fibrinogen and albumin levels in patients with LC and previous inflammatory lung disease awaiting lung resection .
METHODS	We conducted a randomized clinical trial with 24 patients who were randomly assigned to Pulmonary Rehabilitation ( PR ) and Chest Physical Therapy ( CPT ) groups .
METHODS	Each group underwent training 5 days weekly for 4 weeks .
METHODS	All patients were assessed before and after four weeks of training through clinical assessment , measurement of fibrinogen and albumin levels , spirometry , 6-minute Walk Test ( 6MWT ) , quality of life survey , and anxiety and depression scale .
METHODS	PR involved strength and endurance training , and CPT involved lung expansion techniques .
METHODS	Both groups attended educational classes .
RESULTS	A mixed between-within subjects analysis of variance ( ANOVA ) revealed a significant interaction between time ( before and after intervention ) and group ( PR vs. CPT ) on fibrinogen levels ( F ( 1 , 22 ) = 0.57 , p < 0.0001 ) and a significant main effect of time ( F ( 1 , 22 ) = 0.68 , p = 0.004 ) .
RESULTS	Changes in albumin levels were not statistically significant relative to the interaction effect between time and group ( F ( 1 , 22 ) = 0.96 , p = 0.37 ) nor the main effects of time ( F ( 1 , 22 ) = 1.00 , p = 1.00 ) and group ( F ( 1 , 22 ) = 0.59 , p = 0.45 ) .
RESULTS	A mixed between-within subjects ANOVA revealed significant interaction effects between time and group for the peak work rate of the unsupported upper limb exercise ( F ( 1 , 22 ) = 0.77 , p = 0.02 ) , endurance time ( F ( 1 , 22 ) = 0.60 , p = 0.001 ) , levels of anxiety ( F ( 1 , 22 ) = 0.60 , p = 0.002 ) and depression ( F ( 1 , 22 ) = 0.74 , p = 0.02 ) , and the SF-36 physical component summary ( F ( 1 , 22 ) = 0.83 , p = 0.07 ) .
CONCLUSIONS	PR reduced serum fibrinogen levels , improved functional parameters , and quality of life of patients with LC and inflammatory lung disease awaiting lung resection .
BACKGROUND	Current Controlled Trials RBR-3nm5bv .

###25765696
BACKGROUND	The EXAMINE trial showed non-inferiority of the DPP-4 inhibitor alogliptin to placebo on major adverse cardiac event ( MACE ) rates in patients with type 2 diabetes and recent acute coronary syndromes .
BACKGROUND	Concerns about excessive rates of in-hospital heart failure in another DPP-4 inhibitor trial have been reported .
BACKGROUND	We therefore assessed hospital admission for heart failure in the EXAMINE trial .
METHODS	Patients with type 2 diabetes and an acute coronary syndrome event in the previous 15-90 days were randomly assigned alogliptin or placebo plus standard treatment for diabetes and cardiovascular disease prevention .
METHODS	The prespecified exploratory extended MACE endpoint was all-cause mortality , non-fatal myocardial infarction , non-fatal stroke , urgent revascularisation due to unstable angina , and hospital admission for heart failure .
METHODS	The post-hoc analyses were of cardiovascular death and hospital admission for heart failure , assessed by history of heart failure and brain natriuretic peptide ( BNP ) concentration at baseline .
METHODS	We also assessed changes in N-terminal pro-BNP ( NT-pro-BNP ) from baseline to 6 months .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00968708 .
RESULTS	5380 patients were assigned to alogliptin ( n = 2701 ) or placebo ( n = 2679 ) and followed up for a median of 533 days ( IQR 280-751 ) .
RESULTS	The exploratory extended MACE endpoint was seen in 433 ( 160 % ) patients assigned to alogliptin and in 441 ( 165 % ) assigned to placebo ( hazard ratio [ HR ] 098 , 95 % CI 086-112 ) .
RESULTS	Hospital admission for heart failure was the first event in 85 ( 31 % ) patients taking alogliptin compared with 79 ( 29 % ) taking placebo ( HR 107 , 95 % CI 079-146 ) .
RESULTS	Alogliptin had no effect on composite events of cardiovascular death and hospital admission for heart failure in the post hoc analysis ( HR 100 , 95 % CI 082-121 ) and results did not differ by baseline BNP concentration .
RESULTS	NT-pro-BNP concentrations decreased significantly and similarly in the two groups .
CONCLUSIONS	In patients with type 2 diabetes and recent acute coronary syndromes , alogliptin did not increase the risk of heart failure outcomes .
BACKGROUND	Takeda Development Center Americas .

###24393134
BACKGROUND	Umeclidinium bromide ( UMEC ) is an inhaled long-acting muscarinic antagonist in development for chronic obstructive pulmonary disease ( COPD ) .
METHODS	This was a multicentre , randomised , double-blind , placebo-controlled , three-way cross-over , incomplete block study to evaluate UMEC 15.6 , 31.25 , 62.5 , and 125 g administered once daily ( QD ) , and UMEC 15.6 g and 31.25 g administered twice daily ( BID ) , over 7 days in patients with COPD .
METHODS	Tiotropium was included as an open-label treatment arm .
METHODS	The primary efficacy endpoint was trough forced expiratory volume in 1 second ( FEV1 ) on Day 8 .
METHODS	Secondary efficacy endpoints included weighted mean FEV1 over 0-24 hours after morning dosing on Day 7 , and serial FEV1 at each time point over 24 hours after morning dosing on Day 7 .
METHODS	Safety and pharmacokinetics were also examined .
RESULTS	One hundred and sixty-three patients ( mean age 59.5 years , 52 % female ) were randomised .
RESULTS	Based on the population dose-response model of trough FEV1 data , the geometric mean potency ( ED50 ) of UMEC was 37 g ( 95 % confidence interval [ CI ] : 18 , 57 ) with a predicted maximum intrinsic efficacy ( Emax ) at trough of 0.185 L ( 95 % CI : 0.153 , 0.218 ) after QD dosing .
RESULTS	UMEC 125 g QD demonstrated the greatest improvements in measure of lung function compared with doses of 62.5 g and below .
RESULTS	UMEC 125 g QD exhibited more consistent increases in FEV1 from baseline across serial time points over 24 hours compared with other UMEC doses and tiotropium .
RESULTS	Increases in FEV1 over 0-12 hours were similar to those observed over 12-24 hours after the second dose of UMEC was administered .
RESULTS	UMEC was rapidly absorbed following inhaled dosing and eliminated from plasma .
RESULTS	Adverse events , generally mild , were highest with UMEC 125 g QD ( 18 % ) compared with placebo ( 8 % ) , tiotropium ( 4 % ) and other UMEC doses ( 5-12 % ) .
CONCLUSIONS	UMEC is a potent QD bronchodilator with geometric mean ED50 of 37 g.
CONCLUSIONS	A dose ordering over the range of UMEC 15.6-125 g QD doses was observed , with UMEC 125 g showing the greatest improvement in trough FEV1 .

###25438877
BACKGROUND	Non-adherence with antipsychotic medication is a frequently occurring problem , particularly among patients with psychotic disorders .
BACKGROUND	Prior research has generally shown encouraging results for interventions based on ` Contingency Management ' ( CM ) , in which desirable behaviour is encouraged by providing rewards contingent upon the behaviour .
BACKGROUND	However , little is known about the application of CM on medication adherence in patients with psychotic disorders .
BACKGROUND	An earlier pilot-study by our study group showed promising results in reducing admission days and increasing adherence .
BACKGROUND	The current study is a randomized controlled trial concerning the effectiveness of a CM procedure called ` Money for Medication ' ( M4M ) , aimed at improving adherence with antipsychotic depot medication in psychotic disorder patients .
METHODS	Outpatients ( n = 168 ) with a psychotic disorder will be randomly assigned to either the experimental group ( n = 84 ) , receiving a financial reward for each accepted antipsychotic medication depot , or the control group ( n = 84 ) , receiving treatment as usual without financial rewards .
METHODS	Patients are included regardless of their previous adherence .
METHODS	The intervention has a duration of twelve months .
METHODS	During the subsequent six months follow-up , the effects of discontinuing the intervention on depot acceptance will be assessed .
METHODS	The primary goal of this study is to assess the effectiveness of providing financial incentives for improving adherence with antipsychotic depot medication ( during and after the intervention ) .
METHODS	The primary outcome measure is the percentage of accepted depots in comparison to prescription .
METHODS	Secondary , we will consider alternative measures of medication acceptance , i.e. the longest period of uninterrupted depot acceptance and the time expired before depot is taken .
METHODS	Additionally , the effectiveness of the experimental intervention will be assessed in terms of psychosocial functioning , substance use , medication side-effects , quality of life , motivation , cost-utility and patients ' and clinicians ' attitudes towards M4M .
CONCLUSIONS	This RCT assesses the effectiveness and side-effects of financial incentives in improving adherence with antipsychotic depot medication in patients with psychotic disorders .
CONCLUSIONS	This study is designed to assess whether M4M is an effective intervention to improve patients ' acceptance of their antipsychotic depot medication and to examine how this intervention contributes to patients ' functioning and wellbeing .
BACKGROUND	NTR2350 .

###26182769
BACKGROUND	Percutaneous coronary interventions are almost always preceded by the loading dose of platelets inhibiter drugs such as clopidogrel or prasugrel and followed by maintenance therapy to decrease the mortality and morbidity due to stent thrombosis .
BACKGROUND	This study was conducted to compare the efficacy of clopidogrel and prasugrel for inhibiting platelet aggregation among patients undergoing elective percutaneous coronary intervention .
METHODS	This randomized controlled trial study was done in Department of Cardiology , Postgraduate Medical Institute Govt .
METHODS	Lady Reading Hospital Peshawar .
METHODS	A total of 148 patients were randomly allocated to either group-A containing 74 patients using clopidogrel or group-B containing 74 patients using prasugrel
RESULTS	Group-A had 55 ( 74.3 % ) male and 19 ( 25.7 % ) females while group-B had 56 ( 75.7 % ) males and 18 ( 24.3 % ) females ( p = 0.85 ) .
RESULTS	Mean age was 54.9 + / - 11.2 years in group-A and was 57.7 + / - 8.7 years in group-B ( p = 0.09 ) .
RESULTS	Mean body weight was 71.8 ?
RESULTS	6.4 Kg in group-A and 70.8 + / - 6.3 Kg in group-B ( p = 0.35 ) .
RESULTS	Mean Baseline platelet aggregation before drug administration was 10.43 + / - 1.9 ohm in group-A while 10.12 + / - 2.2 ohm in group-B ( p = 0.36 ) .
RESULTS	Mean Follow up platelet aggregation 6 hours after drug administration was 5.88 + / - 2.9 in group-A while it was 3.47 + / - 1.8 ohm in group-B ( p = 0.001 ) .
RESULTS	Mean Difference between basal and follow up platelet aggregation + / - SD was 52.9649 + / - 24.77 in group-A while it was 82.25 + / - 14.34 in group-B ( p = 0.001 ) .
RESULTS	63 ( 85.15 % ) of group-A had inhibition of platelets aggregation > 10 % as compare to 72 ( 97.3 % ) of group-B had inhibition of platelets aggregation > 10 % ( p = 0.009 ) .
CONCLUSIONS	Prasugrel is more efficacious than clopidogrel in term of inhibition of platelets aggregation .

###24890141
BACKGROUND	Short-segment U-shaped pedicle screw fixation has been widely used to treat thoracolumbar burst fracture .
BACKGROUND	Some studies have reported the disadvantages of traditional U-shaped pedicle screw , which included a relatively high rate of adjacent segment degeneration and screw failure , including screw pullout and breakage .
BACKGROUND	The purpose of this study was to assess the efficacy of open reduction and fixation using KumaFix fixation system in treatment of thoracolumbar burst fractures .
METHODS	From June 2011 to June 2012 , 45 consecutive patients with thoracolumbar burst fractures were enrolled .
METHODS	They were randomly assigned to treatment with KumaFix ( the treatment group , n = 23 ) or traditional U-shaped pedicle screw ( the control group , n = 22 ) .
METHODS	The patients were followed up postoperatively and were assessed with regard to radiologic and clinical outcomes .
METHODS	Radiologic outcomes were assessed mainly on the basis of Cobb angle and vertebral wedge angle .
METHODS	Clinical outcomes were evaluated mainly with use of Visual Analog Scale ( VAS ) for pain and the Oswestry Disability Index ( ODI ) Questionnaire .
RESULTS	All patients were followed up from 9 to 22 months .
RESULTS	There were no significant differences between the two groups with regard to preoperative indices .
RESULTS	The operation time in the treatment group was significantly lower than that in the control group .
RESULTS	Preoperative Cobb angles and vertebral wedge angles in two groups were significantly decreased after surgery , and these have been well maintained at the last follow-up with mild correction losses .
RESULTS	The results of clinical outcome showed lower VAS and ODI scores in two groups compared with those preoperative , and the treatment group had greater improvement on the ODI compared with the control group at the last follow-up .
CONCLUSIONS	Compared with traditional U-shaped pedicle screw , KumaFix fixation system can achieve gradual , controlled reduction , provide enough space for bone implantation , and avoid acceleration of adjacent segment degeneration .
CONCLUSIONS	It is an effective and reliable technique to treat thoracolumbar burst fractures .

###24229558
BACKGROUND	Educating emergency medical staffs in triage skills is an important aspect of disaster preparedness .
BACKGROUND	The aim of the study was to compare the effect of role-playing and educational video presentation on the learning and performance of the emergency medical service staffs in Khozestan , Iran
METHODS	A total of 144 emergency technicians were randomly classified into two groups .
METHODS	A researcher trained the first group using an educational video method and the second group with a role-playing method .
METHODS	Data were collected before , immediately , and 15 days after training using a questionnaire covering the three domains of demographic information , triage knowledge , and triage performance .
METHODS	The data were analyzed using defined knowledge and performance parameters .
RESULTS	There was no significant difference between the two training methods on performance and immediate knowledge ( P = .2 ) , lasting knowledge ( P = .05 ) and immediate performance ( P = .35 ) , but there was a statistical advantage for the role-playing method on lasting performance ( P = .02 ) .
CONCLUSIONS	The two educational methods equally increase knowledge and performance , but the role-playing method may have a more desirable and lasting effect on performance .

###25178383
OBJECTIVE	This study evaluated preferences for shared decision making with respect to mental health treatment in a sample of veterans who were diagnosed as having serious mental illness .
METHODS	Participants were 239 outpatients receiving care from the Department of Veterans Affairs who completed self-report questionnaires assessing demographic factors , shared decision-making preferences , psychiatric symptom severity , and the therapeutic relationship with their second-generation antipsychotic prescribers ( N = 21 ) .
METHODS	Preferences were assessed in regard to three components of decision making : knowledge about mental illness , options about mental health treatment , and decisions about mental health care .
RESULTS	Most participants ( 85 % ) indicated that they preferred to be offered options and to be asked their opinions about mental health treatment .
RESULTS	More variability was noted in preferences for obtaining knowledge and making final treatment decisions ; 61 % preferred to rely on their providers ' knowledge and 64 % preferred their provider to make treatment final decisions .
RESULTS	Greater preferences for participation in shared decision making were found among African American clients , those currently working for pay , those with college or higher education , those with other than a schizophrenia spectrum diagnosis , and those who reported a poorer therapeutic relationship with their prescribers .
CONCLUSIONS	The degree to which veterans with serious mental illness desired to participate in their mental health care differed in terms of the aspect of care and across demographic and clinical factors .
CONCLUSIONS	A thorough assessment of shared decision-making preferences is an important component of recovery-oriented , client-centered care .

###24525910
OBJECTIVE	To examine the imaging-detected mechanism of reduction of structural joint damage progression by tocilizumab ( TCZ ) in patients with rheumatoid arthritis ( RA ) using MRI .
METHODS	In a substudy of a randomised , double-blind , phase 3b study ( ACT-RAY ) of biologic-nave patients with RA who were methotrexate ( MTX ) - inadequate responders , 63 patients were randomised to continue MTX or receive placebo ( PBO ) , both in combination with TCZ 8 mg/kg every 4 weeks , with optional additional disease-modifying antirheumatic drugs at week 24 if Disease Activity Score of 28 joints < 3.2 .
METHODS	The most symptomatic hand was imaged with 0.2 Tesla extremity MRI at weeks 0 , 2 , 12 and 52 .
METHODS	MR images were scored using Outcome Measures in Rheumatology-Rheumatoid Arthritis Magnetic Resonance Imaging Score .
METHODS	Predictors of week 52 erosion progression were determined by logistic regression analysis .
RESULTS	TCZ + PBO ( n = 32 ) demonstrated mean improvements in synovitis from baseline to weeks 2 ( -0.92 ; p = 0.0011 ) , 12 ( -1.86 ; p < 0.0001 ) and 52 ( -3.35 ; p < 0.0001 ) , while TCZ + MTX ( n = 31 ) had mean improvements in synovitis at week 12 ( -0.88 ; p = 0.0074 ) , but not week 52 ( -1.00 ; p = 0.0711 ) .
RESULTS	TCZ+PBO demonstrated mean reductions in osteitis at weeks 12 ( -5.10 ; p = 0.0022 ) and 52 ( -8.56 ; p = 0.0006 ) , while TCZ+MTX had mean reductions at weeks 2 ( -0.21 ; p < 0.05 ) and 12 ( -3.63 ; p = 0.0008 ) , but not week 52 ( -2.31 ; p = 0.9749 ) .
RESULTS	Mean erosion scores did not worsen in either group .
RESULTS	MRI erosion scores at weeks 12 and 52 correlated strongly with radiography erosion scores at week 52 ( r > 0.80 ) .
RESULTS	Baseline synovitis and worsening of osteitis predicted erosion progression .
CONCLUSIONS	Rapid suppression of synovitis and osteitis with reduction in structural joint damage progression occurred with TCZ , as monotherapy or in combination with MTX , through week 52 .

###25008853
BACKGROUND	Recent posttrial analysis of a completed randomized trial found an increased risk of prostate cancer among healthy men taking high-dose vitamin E supplements .
BACKGROUND	Trials that examined the effect of vitamin C supplements on cancer risk are few .
OBJECTIVE	We examined whether vitamin E or vitamin C supplementation affects the risk of cancer events during posttrial follow-up of the Physicians ' Health Study II .
METHODS	Beginning in 1997 , a total of 14,641 US male physicians aged 50 y were randomly assigned to receive 400 IU of vitamin E every other day , 500 mg of vitamin C daily , or their respective placebos .
METHODS	The vitamin E and vitamin C treatment ended in 2007 , and observational follow-up continued through June 2011 .
RESULTS	This study included an additional 356 cases of incident prostate cancer and 771 total cancers that developed during a mean ( maximum ) of 2.8 ( 3.8 ) y of posttrial observation .
RESULTS	During an overall mean of 10.3 ( 13.8 ) y , there were a total of 1373 incident prostate cancers and 2669 total cancers documented .
RESULTS	In comparison with placebo , vitamin E supplementation had no effect on the incidence of prostate cancer ( HR : 0.99 ; 95 % CI : 0.89 , 1.10 ) or total cancers ( HR : 1.02 ; 95 % CI : 0.95 , 1.10 ) .
RESULTS	There was also no effect of vitamin C supplementation on total cancers ( HR : 1.02 ; 95 % CI : 0.94 , 1.10 ) or incident prostate cancer ( HR : 1.03 ; 95 % CI : 0.93 , 1.15 ) .
RESULTS	Neither vitamin E nor vitamin C supplementation had effects on other site-specific cancers overall .
RESULTS	Stratification by known cancer risk factors , history of cancer , other randomized treatment , and follow-up time showed no significant interactions .
CONCLUSIONS	In this large-scale randomized trial in men , vitamin E and C supplementation had no immediate or long-term effects on the risk of total cancers , prostate cancer , or other site-specific cancers .

###25548848
BACKGROUND	Although millions of aesthetic procedures are performed annually , few patient-reported outcome ( PRO ) measures have been used in this setting .
OBJECTIVE	To evaluate the impact of onabotulinumtoxinA treatment for crow 's feet lines ( CFL ) on relevant psychological variables and self-perception of age/appearance in subgroup populations .
METHODS	Facial Lines Outcomes ( FLO-11 ) Questionnaire , Self-Perception of Age ( SPA ) , and Subject Global Assessment of Change in CFL ( SGA-CFL ) were PRO measures administered in 2 Phase 3 , double-blind placebo-controlled trials for the treatment of CFL alone or CFL/glabellar lines ( GL ) .
METHODS	Patient-reported outcome measures were analyzed by subgroups ( age , gender , and baseline CFL severity ) .
METHODS	Subject satisfaction with appearance was also analyzed .
RESULTS	Most subgroups receiving onabotulinumtoxinA demonstrated significant improvements in psychological impact ( FLO-11 Items 2 , 5 , and 8 ) versus placebo at Day 30 ( p .05 ) .
RESULTS	OnabotulinumtoxinA-treated subjects consistently rated themselves as looking younger on SPA versus placebo in all subgroups at Day 30 ( p .05 ) and showed significant improvements in CFL appearance versus placebo at all time points on SGA-CFL .
RESULTS	Overall , subjects were satisfied with their appearance .
CONCLUSIONS	OnabotulinumtoxinA-treated subjects experienced significant improvements in perceived appearance , attractiveness , tiredness , age , and satisfaction versus placebo .
CONCLUSIONS	Subjects treated for CFL and GL experienced even greater effects .

###24440236
OBJECTIVE	Retrospective single institution data suggest that postoperative pain after robot-assisted laparoscopic radical prostatectomy is decreased by early removal of the urethral catheter with suprapubic tube drainage .
OBJECTIVE	In a randomized patient population we determined whether suprapubic tube drainage with early urethral catheter removal would improve postoperative pain compared with urethral catheter drainage alone .
METHODS	Men with a body mass index of less than 40 kg/m ( 2 ) who had newly diagnosed prostate cancer and elected robot-assisted laparoscopic radical prostatectomy were included in analysis .
METHODS	Block randomization by surgeon was used and randomization assignment was done after completing the urethrovesical anastomosis .
METHODS	In patients assigned to suprapubic tube drainage the urethral catheter was removed on postoperative day 1 and all catheters were removed on postoperative day 7 .
METHODS	Visual analog pain scale and satisfaction questionnaires were administered on postoperative days 0 , 1 and 7 .
RESULTS	A total of 29 patients were randomized to the urethral catheter vs 29 to the suprapubic tube plus early urethral catheter removal at the time of interim futility analysis .
RESULTS	Mean visual analog pain scale scores did not differ between the groups at any time point and a similar percent of patients cited the catheter as the greatest bother with nonsignificant differences in treatment related satisfaction .
RESULTS	Complications during postoperative week 1 did not vary between the groups .
RESULTS	Based on interim results the trial was terminated due to lack of effect .
CONCLUSIONS	Patients randomized to suprapubic tube vs urethral catheter drainage for the week after prostatectomy had similar pain , catheter related bother and treatment related satisfaction in the perioperative period .
CONCLUSIONS	We no longer routinely offer suprapubic tube drainage with early urethral catheter removal at our institution .

###24342198
OBJECTIVE	To investigate the clinical effect of combination therapy with high-frequency oscillation ventilation ( HFOV ) , pulmonary surfactant ( PS ) and inhaled nitric oxide ( iNO ) in the treatment of neonatal hypoxemic respiratory failure ( HRF ) .
METHODS	A total of 116 neonates with HRF were studied , and they were randomly divided into two groups : triple therapy ( n = 58 ) and dual therapy ( n = 58 ) .
METHODS	The triple therapy group received HFOV , PS , and iNO , while the dual therapy group received HFOV and iNO .
METHODS	Blood gas values , PaO2/FiO2 ( P/F ) , oxygenation index ( OI ) , and pulmonary arterial pressure ( PA ) were determined before treatment and after 24 and 48 hours of treatment .
METHODS	Among the neonates with different P/F ratios and OI values and with or without persistent pulmonary hypertension of the newborn ( PPHN ) , the treatment outcomes of two groups were compared .
RESULTS	The durations of mechanical ventilation and iNO therapy in the triple therapy group were significantly shorter than in the dual therapy group ( P < 0.01 ) .
RESULTS	After 24 and 48 hours of treatment , the triple therapy group had significantly improve PaO2 and PaCO2 compared with the dual therapy group ( P < 0.01 ) .
RESULTS	After 24 and 48 hours of treatment , the neonates with PPHN in the triple therapy group had significantly decreased PA compared with the dual therapy group ( P < 0.01 ) .
RESULTS	In the cases with a P/F ratio of 50 , the triple group had a significantly higher cure rate than the dual therapy group ( P < 0.05 ) .
RESULTS	In both groups , the P/F ratios of the neonates who died were significantly lower than those of survivors ( P < 0.01 ) .
RESULTS	In the cases with an OI of 40 , the triple group had a significantly higher cure rate than the dual therapy group ( P < 0.05 ) .
RESULTS	In both groups , the OI values of the neonates who died were significantly higher than those of survivors ( P < 0.01 ) .
RESULTS	In neonates with PPHN , the triple group had a significantly higher cure rate than the dual therapy group ( P < 0.05 ) .
RESULTS	The triple therapy group had a significantly shorter length of hospital stay ( P < 0.01 ) and a significantly higher cure rate ( P < 0.05 ) compared with the dual therapy group .
RESULTS	There were no significant differences in complications between the two groups ( P > 0.05 ) .
RESULTS	No severe side effect was found during the treatment in either group .
CONCLUSIONS	Triple therapy with HFOV , PS and iNO is a more effective treatment for neonatal HRF compared with the dual therapy with HFOV and iNO .
CONCLUSIONS	The triple therapy can significantly improve oxygenation and survival rate , providing a new treatment for the neonates with HRF , especially the critical cases who suffer severe lung disease with PPHN and have a P/F ratio of 50 or an OI of 40 .

###25478237
OBJECTIVE	Several neuroscience tools showed the involvement of auditory cortex in chronic tinnitus .
OBJECTIVE	In this proof-of-principle study we probed the capability of functional near-infrared spectroscopy ( fNIRS ) for the measurement of brain oxygenation in auditory cortex in dependence from chronic tinnitus and from intervention with transcranial magnetic stimulation .
METHODS	Twenty-three patients received continuous theta burst stimulation over the left primary auditory cortex in a randomized sham-controlled neuronavigated trial ( verum = 12 ; placebo = 11 ) .
METHODS	Before and after treatment , sound-evoked brain oxygenation in temporal areas was measured with fNIRS .
METHODS	Brain oxygenation was measured once in healthy controls ( n = 12 ) .
RESULTS	Sound-evoked activity in right temporal areas was increased in the patients in contrast to healthy controls .
RESULTS	Left-sided temporal activity under the stimulated area changed over the course of the trial ; high baseline oxygenation was reduced and vice versa .
CONCLUSIONS	By demonstrating that rTMS interacts with auditory evoked brain activity , our results confirm earlier electrophysiological findings and indicate the sensitivity of fNIRS for detecting rTMS induced changes in brain activity .
CONCLUSIONS	Moreover , our findings of trait - and state-related oxygenation changes indicate the potential of fNIRS for the investigation of tinnitus pathophysiology and treatment response .

###24346235
BACKGROUND	To evaluate the effect of combination of ranibizumab and laser photocoagulation to peripheral retinal areas of nonperfusion in patients with non-ischemic central retinal vein occlusion ( CRVO ) without neovascularizations .
METHODS	This prospective , proof of concept study randomized 22 CRVO patients into two arms .
METHODS	The RL group ( ranibizumab + laser ; n = 10 ) received ranibizumab with additive laser photocoagulation ; the control R group ( n = 12 ) was treated with ranibizumab only .
METHODS	All patients received three initial monthly ranibizumab injections followed by PRN regimen .
METHODS	Changes in best corrected visual acuity ( BCVA ) and in central retinal thickness ( CRT ) were documented over 6 months .
RESULTS	Median of BCVA improved in the RL group from 65 ETDRS letters ( interquartile range IQR = 10 letters ) at baseline to 70 ( IQR = 23.2 ) letters at month 6 .
RESULTS	In the control group BCVA remained stable [ baseline : 61 ( IQR = 19.5 ) and month 6 : 61 ( IQR = 22 ) letters ] .
RESULTS	CRT decreased between baseline and final visit in the RL group from 547 ( IQR = 513 ) m to 246.5 ( IQR = 346.3 ) m , and in the control group from 637.5 ( IQR = 344 ) m to 423 ( IQR = 737 ) m.
RESULTS	More pronounced improvements in BCVA were seen in the RL group ( medians = 14 vs. 6.5 letters ) although the observed group differences were not statistically significant due to small samples .
CONCLUSIONS	The selective laser photocoagulation of peripheral areas of nonperfusion seems to lead to additional visual improvement in patients with CRVO .
CONCLUSIONS	A larger replication trial is necessary to confirm the results of this proof of concept study .

###25452653
OBJECTIVE	To evaluate the effectiveness of a coparenting intervention on exclusive breastfeeding among primiparous mothers and fathers .
METHODS	A randomized controlled trial was conducted in a large teaching hospital in Toronto , Canada .
METHODS	Couples were randomized to receive either usual care ( n = 107 ) or a coparenting breastfeeding support intervention ( n = 107 ) .
METHODS	Follow-up of exclusive breastfeeding and diverse secondary outcomes was conducted at 6 and 12 weeks postpartum .
RESULTS	Significantly more mothers in the intervention group than in the control group continued to breastfeed at 12 weeks postpartum ( 96.2 % vs 87.6 % , P = .02 ) .
RESULTS	Although proportionately more mothers in the intervention group were exclusively breastfeeding at 6 and 12 weeks , these differences were not significant .
RESULTS	Fathers in the intervention group had a significantly greater increase in breastfeeding self-efficacy scores from baseline to 6 weeks postpartum compared with fathers in the control group ( P = .03 ) .
RESULTS	In addition , significantly more mothers in the intervention group than in the control group reported that their partners provided them with breastfeeding help in the first 6 weeks ( 71 % vs 52 % , P = .02 ) and that they were satisfied with their partners ' involvement with breastfeeding ( 89 % vs 78.1 % , P = .04 ) .
RESULTS	Mothers in the intervention group were also more satisfied with the breastfeeding information they received ( 81 % vs 62.5 % , P < .001 ) .
CONCLUSIONS	The significant improvements in breastfeeding duration , paternal breastfeeding self-efficacy , and maternal perceptions of paternal involvement and assistance with breastfeeding suggest that a coparenting intervention involving fathers warrants additional investigation .

###25147819
OBJECTIVE	To examine the effect of rilonacept on the health-related quality of life ( HRQoL ) in patients with poorly controlled familial Mediterranean fever ( FMF ) .
METHODS	As part of a randomized , double-blinded trial comparing rilonacept and placebo for the treatment of FMF , patients/parents completed the modified Child Health Questionnaire ( CHQ ) at baseline , and at the start and end of each of 4 treatment courses , 2 each with rilonacept and placebo .
RESULTS	Fourteen subjects were randomized ; mean age was 24.4 11.8 years .
RESULTS	At baseline the physical HRQoL score was significantly less ( 24.2 49.5 ) but the psychosocial score was similar to the population norm ( 49.5 10.0 ) .
RESULTS	There were significant improvements in most HRQoL concepts after rilonacept but not placebo .
RESULTS	Significant differences between rilonacept and placebo were found in the physical ( 33.7 16.4 versus 23.7 14.5 , P = 0.021 ) but not psychosocial scores ( 51.4 10.3 versus 49.8 12.4 , P = 0.42 ) .
RESULTS	The physical HRQoL was significantly impacted by the treatment effect and patient global assessment .
CONCLUSIONS	Treatment with rilonacept had a beneficial effect on the physical HRQoL in patients with poorly controlled FMF and was also significantly related to the patient global assessment .
CONCLUSIONS	This trial is registered with ClinicalTrials.gov Identifier NCT00582907 .

###25438232
BACKGROUND	An elevated resting heart rate ( RHR ) may be an early sign of cardiac failure , but its prognostic value during watchful waiting in asymptomatic aortic stenosis ( AS ) is largely unknown .
METHODS	RHR was determined by annual ECGs in the Simvastatin and Ezetimibe in Aortic Stenosis ( SEAS ) study of asymptomatic mild-to-moderate AS patients .
METHODS	Primary endpoint in this substudy was major cardiovascular events ( MCEs ) and secondary outcomes its individual components .
METHODS	Multivariable Cox-models using serially-measured RHR were used to examine the prognostic impact of RHR per se .
RESULTS	1563 patients were followed for a mean of 4.3 years ( 6751 patient-years of follow-up ) , 553 ( 35 % ) MCEs occurred , 10 % ( n = 151 ) died , including 75 cardiovascular deaths .
RESULTS	In multivariable analysis , baseline RHR was independently associated with MCEs ( HR 1.1 per 10min ( -1 ) faster , 95 % CI : 1.0-1 .3 ) and cardiovascular mortality ( HR 1.3 per 10min ( -1 ) faster , 95 % CI : 1.0-1 .7 , both p0 .03 ) .
RESULTS	Updating RHR with annual in-study reexaminations , time-varying RHR was highly associated with excess MCEs ( HR 1.1 per 10min ( -1 ) faster , 95 % CI : 1.1-1 .3 ) and cardiovascular mortality ( HR 1.4 per 10min ( -1 ) faster , 95 % CI : 1.2-1 .7 , both p0 .006 ) .
RESULTS	The association of RHR with MCEs and cardiovascular mortality was not dependent on atrial fibrillation status ( both p0 .06 for interaction ) .
CONCLUSIONS	RHR is independently associated with MCEs and cardiovascular death in asymptomatic AS ( Clinicaltrials.gov ; unique identifier NCT00092677 ) .

###24566573
OBJECTIVE	The aim of the present study was to evaluate the efficacy and safety of narrowband UVB ( NB-UVB ) compared with tacrolimus ointment 0.1 % in patients with bilateral vitiligo .
METHODS	In this comparative study , four groups of patients were randomized .
METHODS	Each group was composed by 12 patients with bilateral vitiligo ; in each group , every patient was irradiated with NB-UVB ( length : 311 nm ) twice a week for 9 months and applied tacrolimus ointment 0.1 % twice a day on the other area in the same period .
METHODS	Before starting therapy and after 3 , 6 and 9 months of therapy , a clinical and photographic evaluation of percentage of repigmentation was performed and Dermatology Life Quality Index Questionnaire was fulfilled .
RESULTS	A repigmentation at least partial occurred in 71 % of patients after 36 weeks of treatment with tacrolimus ointment 0.1 % ; in the whole sample , 14 patients ( 29 % ) showed no repigmentation at all , with 2 of them discontinuing the therapy because of side effects ( erythema and folliculitis-like manifestations ) .
RESULTS	A homogeneous repigmentation at least partial occurred in 69 % of patients after 36 weeks of treatment with NB-UVB ; in the whole sample 15 patients ( 31 % ) showed no repigmentation at all , with 1 of them discontinuing the therapy because of side effects .
CONCLUSIONS	The present study confirmed that the efficacy of NB-UVB phototherapy in vitiligo is comparable to tacrolimus ointment 0.1 % therapy .
CONCLUSIONS	On the basis of our study , we may suggest tacrolimus ointment 0.1 % as an alternative to NB-UVB therapy for treating vitiligo .

###24268570
OBJECTIVE	In order to quantify the effects of physical activity such as walking on chronic disease , accurate measurement of physical activity is needed .
OBJECTIVE	The objective of this study was to determine the validity and reliability of a new activity monitor , the Fitbit One , in a population of healthy adults .
METHODS	Cross-sectional study .
METHODS	Thirty healthy adults ambulated at 5 different speeds ( 0.90 , 1.12 , 1.33 , 1.54 , 1.78 m/s ) on a treadmill while wearing three Fitbit One activity monitors ( two on the hips and one in the pocket ) .
METHODS	The order of each speed condition was randomized .
METHODS	Fitbit One step count output was compared to observer counts and distance output was compared to the calibrated treadmill output .
METHODS	Two-way repeated measures ANOVA , concordance correlation coefficients , and Bland and Altman plots were used to assess validity and intra-class correlation coefficients ( ICC ) were used to assess reliability .
RESULTS	No significant differences were noted between Fitbit One step count outputs and observer counts , and concordance was substantial ( 0.97-1 .00 ) .
RESULTS	Inter-device reliability of the step count was high for all walking speeds ( ICC 0.95 ) .
RESULTS	Percent relative error was less than 1.3 % .
RESULTS	The distance output of the Fitbit One activity monitors was significantly different from the criterion values for each monitor at all speeds ( P < 0.001 ) and exhibited poor concordance ( 0.0-0 .05 ) .
RESULTS	Inter-device reliability was excellent for all treadmill speeds ( ICC 0.90 ) .
RESULTS	Percent relative error was high ( up to 39.6 % ) .
CONCLUSIONS	The Fitbit One activity monitors are valid and reliable devices for measuring step counts in healthy young adults .
CONCLUSIONS	The distance output of the monitors is inaccurate and should be noted with caution .

###25557371
OBJECTIVE	Delayed-release dimethyl fumarate ( DMF , also known as gastro-resistant DMF ) , demonstrated efficacy and safety in relapsing-remitting multiple sclerosis in the 2-year , randomized , placebo-controlled , phase 3 DEFINE and CONFIRM trials .
OBJECTIVE	A post hoc analysis of integrated data from DEFINE and CONFIRM was conducted to determine the temporal profile of the clinical and neuroradiological effects of DMF .
METHODS	Eligible patients were randomized to receive placebo , DMF 240mg twice ( BID ) or three times ( TID ) daily or glatiramer acetate ( GA ; reference comparator ; CONFIRM only ) for up to 96weeks .
METHODS	Patients in the GA group were excluded from this analysis .
RESULTS	A total of 2301 patients were randomized and received treatment with placebo ( n = 771 ) or DMF BID ( n = 769 ) or TID ( n = 761 ) .
RESULTS	DMF significantly reduced the annualized relapse rate beginning in weeks 0-12 ( BID , P = 0.0159 ; TID , P = 0.0314 ) ; the proportion of patients relapsed beginning at week 10 ( BID , P = 0.0427 ) and week 12 ( TID , P = 0.0451 ) ; and the proportion of patients with 12-week confirmed disability progression beginning at week 62 ( BID , P = 0.0454 ) and week 72 ( TID , P = 0.0399 ) , compared with placebo .
RESULTS	These effects were sustained throughout the 2-year study period .
RESULTS	DMF significantly reduced the odds of having a higher number of gadolinium-enhancing lesions by 88 % ( BID ) and 75 % ( TID ) and the mean number of new or enlarging T2 lesions by 72 % ( BID ) and 67 % ( TID ) , from the first post-baseline magnetic resonance imaging assessment at 24weeks ( all P < 0.0001 versus placebo ) .
CONCLUSIONS	In phase 3 clinical trials , DMF demonstrated rapid and sustained clinical and neuroradiological efficacy in relapsing-remitting multiple sclerosis .

###24690416
BACKGROUND	Repetitive transcranial magnetic stimulation ( rTMS ) is able to induce changes in neuronal activity that outlast stimulation .
BACKGROUND	The underlying mechanisms are not completely understood .
BACKGROUND	They might be analogous to long-term potentiation or depression , as the duration of the effects seems to implicate changes in synaptic plasticity .
BACKGROUND	Norepinephrine ( NE ) has been shown to play a crucial role in neuronal plasticity in the healthy and injured human brain .
BACKGROUND	Atomoxetine ( ATX ) and other NE reuptake inhibitors have been shown to increase excitability in different systems and to influence learning processes .
BACKGROUND	Thus , the combination of two facilitative interventions may lead to further increase in excitability and motor learning .
BACKGROUND	But in some cases homeostatic metaplasticity might protect the brain from harmful hyperexcitability .
BACKGROUND	In this study , the combination of 60mg ATX and 10Hz rTMS over the primary motor cortex was used to examine changes in cortical excitability and motor learning and to investigate their influence on synaptic plasticity mechanisms .
RESULTS	The results of this double-blind placebo-controlled study showed that ATX facilitated corticospinal and intracortical excitability in motor cortex .
RESULTS	10 Hertz rTMS applied during a motor task was able to further increase intracortical excitability only in combination with ATX .
RESULTS	In addition , only the combination of 10Hz rTMS and ATX was capable of enhancing the total number of correct responses and reaction time significantly , indicating an interaction effect between rTMS and ATX without signs of homeostatic metaplasticity .
CONCLUSIONS	These results suggest that pharmacologically enhanced NE transmission and 10Hz rTMS exert a synergistic effect on motor cortex excitability and motor learning in healthy humans .

###24772989
OBJECTIVE	To investigate whether self care behaviours , medical outcomes and quality of life of Taiwanese elderly with Type 2 diabetes mellitus ( DM ) can be improved by delivery of an educational health care package .
BACKGROUND	DM is a major health problem in developed and developing countries , with older adults constituting about half of the diabetic population .
BACKGROUND	Type 2 DM is the most rapidly increasing chronic disease in Taiwan .
METHODS	During 2005 and 2006 , Taiwanese elderly with Type 2 DM ( n = 500 ) were randomly allocated to either an intervention or control group .
METHODS	Data collection using validated instruments occurred at baseline and 6 months follow-up .
METHODS	Main outcome measures were blood glucose levels and diabetic complications .
RESULTS	At baseline , 88.4 % participants in the control and 78.8 % in the experimental group had a blood glucose level above normal range ( p = 0.076 ) ; respective results at 6 months were 92.4 % for the control group and 60.4 % for the experimental group ( p < 0.001 ) .
RESULTS	The multivariate adjusted result showed that the intervention group was 11.1 times less likely to have blood glucose levels above normal ( p = 0.002 ) at 6 months follow-up compared to the control group .
RESULTS	Occurrence of complications was significantly fewer in the intervention group at baseline and at 6 month follow-up compared to the control group ( baseline : 42.0 % versus 82.1 % , p = 0.003 ; 6 month follow-up : 48.4 % versus 87.0 % ; p = 0.006 ) .
CONCLUSIONS	Although overall occurrence of complications remained unchanged , the educational health care package specifically developed for Taiwanese elderly with Type 2 DM improved blood glucose levels .

###24288691
BACKGROUND	Transnasal esophagogastroduodenoscopy ( EGD ) without sedation has been reported to be safe and tolerable .
BACKGROUND	It has recently been used widely in Japan for the detection of upper gastrointestinal disease .
BACKGROUND	Alternatively , transoral examination using a thin endoscope has also been reported to be highly tolerable .
OBJECTIVE	To examine the cardiocirculatory effects of transoral versus transnasal EGD in an attempt to determine the most suitable endoscopic methods for patients 75 years of age .
METHODS	Subjects who underwent monitoring of respiratory and circulatory dynamics without sedation during endoscopic screening examinations were enrolled at the New Ooe Hospital ( Kyoto , Japan ) between April 2008 and March 2009 .
METHODS	A total of 165 patients ( age 75 years ) provided written informed consent and were investigated in the present study .
METHODS	Patients were randomly divided into three subgroups : UO group -- thin endoscope ; SO group -- standard endoscope ; and UT group -- transnasal EGD .
METHODS	Percutaneous arterial blood oxygen saturation , heart rate and blood pressure were evaluated just before EGD and at five time points during EGD .
METHODS	After transnasal EGD , patients who had previously been examined using transoral EGD with a standard endoscope were asked about preferences for their next examination .
RESULTS	There were no statistical differences in the characteristics among the groups .
RESULTS	Percutaneous oxygen saturation in the UT group showed a transient drop compared with the SO and UO groups at the beginning of the endoscopic procedure .
RESULTS	Heart rate showed no significant differences among the SO , UO and UT groups ; Systolic blood pressure in the UO group was lower immediately after insertion compared with the SO and UT groups .
RESULTS	The rate pressure product in the UO group was comparable with that in the UT group during endoscopy , and the SO group showed a continuously higher level than the UO and UT groups .
RESULTS	More than one-half ( 54.4 % ) of patients were ` willing to choose transnasal EGD for next examination ' .
CONCLUSIONS	For elderly patients , unsedated transnasal EGD failed to show an advantage over unsedated standard endoscopy .
CONCLUSIONS	Transoral thin EGD was estimated to be safe and tolerable .

###25416602
BACKGROUND	Urethrocutaneous fistulae ( UCFs ) represent one of the most frequent causes of morbidity after urethroplasty .
BACKGROUND	Hypospadias can be repaired using different surgical techniques , but-regardless of technique-the incidence of UCF ranges between 10 % and 40 % .
BACKGROUND	Surgical repair of UCF remains the treatment of choice , even if some patients need further surgery because of recurrences .
BACKGROUND	Cyanoacrylates have been used as skin suture substitutes , and some evidence suggests a beneficial effect when these adhesives are used as an adjuvant in the management of UCF .
BACKGROUND	Here we describe the results of management of UCF using 2-octyl cyanoacrylate ( OCA ) compared with surgical repair .
METHODS	A randomized clinical trial conducted from January 2008 to December 2012 included 42 children with UCF complications after urethroplasty for hypospadias .
METHODS	Twenty-one children were assigned to receive OCA as ambulatory patients and 21 were treated surgically .
METHODS	The main outcome variable was closure of the UCF .
METHODS	The estimated costs of both treatments were also calculated , as were absolute risk reduction ( ARR ) , relative risk reduction ( RRR ) and number needed to treat ( NNT ) to prevent a surgical intervention .
RESULTS	The mean numbers of UCF were 1.3 in the OCA group ( n = 28 ) and 1.1 in the surgical group ( n = 25 ) with no statistically significant difference .
RESULTS	The external orifices measured were 2.96 1.0 mm and 3.8 0.89 mm , respectively ( NS ) .
RESULTS	Sixty per cent of the UCFs treated with cyanoacrylate were completely closed and 68 % of the surgical group healed completely ( NS ) .
RESULTS	More than one reoperation to improve complications was needed in the surgical group ( 3.5 1.2 ) .
RESULTS	The clinical significance of the therapeutic usefulness of OCA was demonstrated by an ARR of 0.08 , RRR of 0.25 and NNT of 12 to avoid further surgical treatment .
RESULTS	The total costs of adhesive applications and reoperations were $ US 14,809.00 and $ US 158,538.50 , respectively .
CONCLUSIONS	The results showed a similar success rate for both treatments .
CONCLUSIONS	However , sealant use should be considered before surgical treatment because this is a simple outpatient procedure with a reasonable success rate .
BACKGROUND	ClinicalTrials.gov Identifier : NCT02115191 .
BACKGROUND	Date : April 13 , 2014 .

###25153106
BACKGROUND	Alterations in the vocal folds that involve volume reduction and glottal closure failure result in exaggerated air escape during speech .
BACKGROUND	For such situations , the use of implants or grafts of different materials has been proposed .
OBJECTIVE	To define the effect of sugarcane biopolymer gel when implanted in the vocal folds of rabbits .
METHODS	This was an experimental study .
METHODS	The vocal folds of rabbits injected with sugarcane biopolymer and saline solution were histologically evaluated after 21 and 90 days .
RESULTS	Mild to moderate inflammation and increased volume were observed in all vocal folds injected with biopolymer , when compared to controls .
RESULTS	There were no cases of necrosis or calcification .
CONCLUSIONS	This study showed higher inflammatory reaction in cases than in controls and biopolymer biointegration to the vocal fold .
CONCLUSIONS	This fibrogenic response with absence of epithelial repercussions suggests that the biopolymer in its gel form can be bioactive and preserve the normal vibratory function of the epithelium .
CONCLUSIONS	We show that in spite of producing an inflammatory reaction in vocal fold tissues , the material remained in vocal fold throughout the study period .

###24444140
BACKGROUND	Despite growing interest in psychotherapy in child and adolescent headache , efficacy studies in this research field have focused mainly on cognitive-behavioral therapies .
BACKGROUND	Whereas relaxation and cognitive-behavioral techniques , in particular , have been found to reduce the intensity and frequency of headache in children and adolescents , data on psychodynamic psychotherapy in this population are lacking.Our aim was to explore the effectiveness of a brief psychodynamic psychotherapy program in the treatment of idiopathic headache in childhood and adolescence .
METHODS	Thirty-three newly diagnosed idiopathic headache sufferers aged 6-18 years , consecutively referred to our outpatient services , were randomized to receive either a brief cycle of psychodynamic psychotherapy ( eight sessions administered at two-week intervals ) or usual care ( clinical interview , neurological examination , counselling , symptomatic therapy ) .
METHODS	The two groups were evaluated at baseline ( T0 ) and at six months ( T1 ) to be assessed for headache characteristics ( i.e. frequency , intensity and duration ) , quality of life ( i.e. the EuroQoL score ) , patient 's global health status ( i.e. the Clinical Global Impression score ) , and emotional-behavioral symptoms ( i.e. Child Behavior Checklist scores ) .
RESULTS	The two groups were fairly similar with reference to the main demographic and clinical variables .
RESULTS	The T0/T1 comparison showed a statistically significant improvement in headache frequency ( p = 0.005 ) , intensity ( p < 0.001 ) and duration ( p = 0.002 ) , a statistically significant improvement in the CGI score ( p = 0.018 ) , and a borderline improvement in the EuroQoL score ( p = 0.053 ) in the group receiving psychotherapy .
CONCLUSIONS	According to our pilot findings , a brief psychodynamic psychotherapy program may be more effective than usual care in children and adolescents with idiopathic headache .

###24224808
BACKGROUND	Quinolone-based regimens have been used as the rescue for eradication of Helicobacter pylori .
BACKGROUND	Sitafloxacin is known to have low minimum inhibitory concentration for H.pylori .
BACKGROUND	Here , we compared two sitafloxacin-based eradication regimens as rescue for the eradication of H.pylori .
METHODS	We attempted to eradicate H.pylori in 180 Japanese patients who had never failed in eradication of H.pylori with the triple proton pump inhibitor/amoxicillin/clarithromycin therapy ( 1st line ) and the triple proton pump inhibitor/amoxicillin/metronidazole therapy ( 2nd line ) .
METHODS	They were assigned to either the triple therapy with rabeprazole 10mg b.i.d. / q.i.d. , amoxicillin 500mg q.i.d , and sitafloxacin 100mg b.i.d. ( RAS ) for 1 or 2 weeks or the triple therapy with rabeprazole 10mg b.i.d. / q.i.d. , metronidazole 250mg b.i.d. , and sitafloxacin 100mg b.i.d. ( RMS ) for 1 or 2 weeks .
METHODS	Eradication was assessed via the ( 13 ) C-urea breath test and rapid urease test .
RESULTS	Intention-to-treat and per-protocol analyses of eradication rates were 84.1 % ( 37/44 ) and 86.4 % ( 37/43 ) with RAS for 1 week , 88.9 % ( 40/45 ) and 90.9 % ( 40/44 ) for RAS for 2 weeks , 90.9 % ( 40/44 ) and 90.9 % ( 40/44 ) for 1 week-RMS and 87.2 % ( 41/47 ) and 91.1 % ( 41/45 ) with RMS for 2 weeks .
RESULTS	We noted no statistical significant differences in eradication rates among four regimens .
CONCLUSIONS	All of the above-described rescue regimens proved relatively equally useful in the eradication of H.pylori .
CONCLUSIONS	Of them , RAS for 2 weeks and RMS for 1 or 2 weeks could attain the rescue eradication rates higher than 90 % by per-protocol analysis .

###25361785
OBJECTIVE	To examine the efficacy of an integrative cognitive training program ( REHACOP ) to improve cognition , clinical symptoms , and functional disability of patients with Parkinson disease ( PD ) .
METHODS	Forty-two patients diagnosed with PD in Hoehn & Yahr stages 1 to 3 were randomly assigned to either the cognitive training group ( REHACOP ) or the control group ( occupational activities ) for 3 months ( 3 sessions , 60 min/wk ) .
METHODS	Primary outcomes were change on processing speed , verbal memory , visual memory , executive functioning , and theory of mind .
METHODS	Secondary outcomes included changes on neuropsychiatric symptoms , depression , apathy , and functional disability .
METHODS	The trial was registered with clinicaltrials.gov ( NCT02118480 ) .
RESULTS	No baseline group differences were found .
RESULTS	Bootstrapped analysis of variance results showed significant differences in the mean change scores between the REHACOP group and control group in processing speed ( 0.13 [ SE = 0.07 ] vs -0.15 [ SE = 0.09 ] , p = 0.025 ) , visual memory ( 0.10 [ SE = 0.10 ] vs -0.24 [ SE = 0.09 ] , p = 0.011 ) , theory of mind ( 1.00 [ SE = 0.37 ] vs -0.27 [ SE = 0.29 ] , p = 0.013 ) , and functional disability ( -5.15 [ SE = 1.35 ] vs 0.53 [ SE = 1.49 ] , p = 0.012 ) .
CONCLUSIONS	Patients with PD receiving cognitive training with REHACOP demonstrated statistically significant and clinically meaningful changes in processing speed , visual memory , theory of mind , and functional disability .
CONCLUSIONS	Future studies should consider the long-term effect of this type of intervention .
CONCLUSIONS	These findings support the integration of cognitive training into the standard of care for patients with PD .
METHODS	This study provides Class II evidence that for patients with PD , an integrative cognitive training program improves processing speed , visual memory , theory of mind , and functional disability .

###26211378
BACKGROUND	Observational data indicate that carotid artery stenting ( CAS ) is associated with higher incidence of subclinical cerebral microemboli than carotid endarterectomy ( CEA ) .
BACKGROUND	We hypothesized that CEA would be associated with superior performance on detailed domain-specific cognitive testing compared with CAS .
METHODS	Patients with > 80 % asymptomatic carotid artery stenosis were randomized to CEA or CAS with side of stenosis balanced across condition .
METHODS	A robust battery of tests was used to assess the cognitive domains of attention , memory , mood , visual-spatial skills , motor ability , processing speed , and executive functioning 10 days preoperatively and postoperatively at 6 weeks and 6 months .
METHODS	Tests were administered using standardized conditions and were scored by individuals blinded to treatment allocation .
RESULTS	Baseline cognitive performance was similar between CAS ( n = 29 ) and CEA ( n = 31 ) groups ( P > .05 ) .
RESULTS	Relative to baseline , verbal and visual memory and attention functions substantially improved in the CAS and CEA groups at 6 months ( multiple cognitive tests achieved statistical significance ) .
RESULTS	Compared with CEA , cognitive processing speed ( Stroop Color test : 9.0 vs 7.3 , P = .04 ; and Stroop Word test : 9.0 vs 7.4 , P = .05 ) was superior in the CAS group at 6 weeks .
RESULTS	Executive functioning ( phonemic verbal fluency : 10.6 vs 8.4 , P = .043 ) and motor function ( Grooved Pegboard of nondominant extremity : 45.7 vs 38.9 , P = .022 ) were also superior in the CAS group at 6 months .
RESULTS	Tests of attention , memory , and visual-spatial skills were similar between CAS and CEA patients at 6 weeks and 6 months .
CONCLUSIONS	Carotid revascularization improves memory and attention within the first 6 postoperative months .
CONCLUSIONS	Compared with CEA , CAS produces improvements in cognitive processing speed , executive functioning , and motor function .

###25040192
BACKGROUND	Health utilities measure patients ' preferences for a health state .
OBJECTIVE	To assess health utilities for sofosbuvir-containing therapy for chronic hepatitis C.
METHODS	The SF-6D utility scores were derived from the SF-36 instrument administered at baseline , during and post-treatment to participants of the previously reported clinical trials of sofosbuvir .
METHODS	EQ-5D utility scores were also approximated from the SF-36 using a regression model .
RESULTS	Nine hundred and ninety-four patients were enrolled .
RESULTS	Baseline SF-6D and EQ-5D scores were 0.66 0.13 and 0.71 0.22 , respectively ( the POSITRON trial ) , 0.71 0.16 and 0.76 0.23 ( FISSION ) , 0.70 0.14 and 0.75 0.22 ( FUSION ) , 0.72 0.15 and 0.79 0.22 ( NEUTRINO ) .
RESULTS	In all studies , SF-6D and EQ-5D scores were highly correlated with each other .
RESULTS	( r = 0.83-0 .87 , P < 0.0001 ) .
RESULTS	After 12 weeks , patients receiving sofosbuvir + ribavirin ( POSITRON ) had similar utility scores to placebo ( P > 0.05 ) .
RESULTS	Patients receiving 12 and 16 weeks of sofosbuvir + ribavirin ( FUSION ) had similar utility scores ( P > 0.05 ) .
RESULTS	In FISSION , patients receiving sofosbuvir + ribavirin had significantly better utilities compared to patients receiving interferon + ribavirin ( P < 0.001 ) .
RESULTS	Patients receiving sofosbuvir + ribavirin + interferon ( NEUTRINO ) had a decrease in utilities during treatment ( SF-6D : from 0.72 to 0.62 , EQ-5D : 0.79 to 0.65 ; P < 0.0001 ) similar to that observed in patients receiving pegylated interferon + ribavirin for 24 weeks in FISSION ( 0.72 to 0.62 and 0.77 to 0.65 , respectively , P < 0.0001 ) .
RESULTS	After 12 weeks post-treatment , patients with SVR ( FUSION ) had improvement in SF-6D ( +0.026 from baseline , P = 0.013 ) and EQ-5D ( +0.043 , P = 0.013 ) .
RESULTS	In multivariate analyses , baseline depression , anxiety , fatigue , insomnia and treatment-related anaemia were the most consistent predictors of utilities .
CONCLUSIONS	Patients ' health utilities are minimally impacted by sofosbuvir + ribavirin treatment , as compared to interferon-based , therapy regardless of treatment duration .
CONCLUSIONS	Clinical trials ' numbers : NCT01542788 ( POSITRON ) , NCT01497366 ( FISSION ) , NCT01604850 ( FUSION ) , NCT01641640 ( NEUTRINO ) .

###24254557
BACKGROUND	In our study , the efficiency and reliability of lidocaine ( 1 cc/1 % ) application during transrectal ultrasound-guided ( TRUS ) prostate biopsy to levatores prostate was studied .
BACKGROUND	Levatores prostate was visualized on a cadaver dissection previously .
METHODS	Eighty outpatients with lower urinary tract complaints or were suspected clinically to have prostate cancer were submitted to TRUS-guided prostate biopsy .
METHODS	The ages of outpatients were ranging from 45 to 81 .
METHODS	Patients were randomized in 2 groups : Group-I , with 40 patients submitted to local anesthesia by periprostatic injection of 1 cc 1 % lidocaine before biopsy ; and group-II , with 40 controls the biopsy was performed without local anesthesia .
METHODS	The anatomical region for anesthesia was determined via dissection .
METHODS	The name of this anatomical region is levatores prostatae and it has got high nerve density .
METHODS	The process was explained to the patients and their approvals were obtained .
METHODS	Levatores prostatae was detected with TRUS before biopsy .
METHODS	Pain ; related to digital rectal examination ( DRE ) , probe insertion or biopsy , was scored via visual analog scale ( VAS ) .
METHODS	The patients were evaluated about side effects of lidocaine and early and late complications of biopsy as well .
RESULTS	Both groups were similar in terms of mean age , PSA levels , prostate volume and VAS scores ( p > 0.05 ) .
RESULTS	As for VAS score , on the group submitted to anesthesia was determined 2.34 1.08 , while for VAS score on the group submitted conventional biopsy was determined 5.8 1.6 .
RESULTS	Between two groups , there was a statistical difference in terms of VSA score ( p < 0.05 ) ; but there was no statistical difference about early and late complications of biopsy .
CONCLUSIONS	The periprostatic blockage use is clearly associated with more tolerance and patient comfort during TRUS-guided biopsy .
CONCLUSIONS	Owing to the local anesthesia introduced to the periprostatic nerve bundle localization in levatores prostate area , the patients could tolerate the pain better .

###25304999
OBJECTIVE	To assess the morbidity and efficacy of thermal tissue welder instrument for tonsillectomy and compare it with monopolar electrocautery .
METHODS	IRB approval was obtained at the Wexner Medical Center at Ohio State University for a prospective , randomized , single-blinded , controlled clinical study of 48 healthy adult volunteers undergoing tonsillectomy for chronic tonsillitis and tonsil hypertrophy .
METHODS	Subjects were randomized to the TW or EC group .
METHODS	Post-operative pain , pain medication use , return to normal oral intake , return to normal activity , and bleeding were measured on the post-operative log .
METHODS	We recorded operative time , operating room time , and blood loss .
METHODS	All procedures were performed by one surgeon to eliminate variations in time and experience .
METHODS	Operative and patient data were analyzed using a Student T-test and evaluated by cost analysis .
RESULTS	There was a statically significant increase in operative time with the TW taking an average of 4min longer per procedure , p < 0.001 .
RESULTS	However , when total anesthesia time was compared , this did not translate into a statistically significant increase in total operating room time and therefore did not translate into additional cost .
RESULTS	The remaining categories were not significantly different between the two groups .
RESULTS	In 3/23 TW cases , suction cautery was required for hemostasis .
RESULTS	Two patients had 3 occurrences of secondary bleeding in the electrocautery group and none in the tissue welder group .
RESULTS	TW cost increase per case was $ 167 per instrument but averaged $ 700 per case .
CONCLUSIONS	While the tissue welder remains a viable option for the adult tonsillectomy procedure , it has not demonstrated in our study the necessary parameters intraoperatively , postoperatively , or via cost analysis to become the choice instrument at our institution .
CONCLUSIONS	We can not ignore the increase in cost that may be seen for short and routine procedures without an added benefit to the patient in terms of outcome or safety .
CONCLUSIONS	A larger study is needed to determine if secondary bleeding rates are lower with this instrument .

###26281201
OBJECTIVE	To determine the efficacy of 0.1 % tacrolimus ointment in patients with perianal Crohn 's disease ( CD ) .
METHODS	This prospective randomized trial enrolled 20 patients with perianal CD as anal fissures and rectal fistulas .
METHODS	The inclusion criteria were rectovaginal or extrasphincteric fistulas and purulent leakages .
METHODS	A study group comprised 11 patients , including 9 with anal fissures and 2 with fistulas .
METHODS	A control group included 9 patients , including 8 with fissures and 1 with fistulas .
METHODS	The study group received systemic therapy with azathioprine 2 mg/kg/day and tacrolimus ointment 2 mg/day ; the control group had systemic therapy with azathioprine 2 mg/kg/day , hormone ointment 1 mg/day , and metronidazole suppositories 250 mg/day .
METHODS	Control examination and perianal CD activity index ( PCDAI ) determination were done 6 and 12 weeks after therapy initiation .
RESULTS	At 6 weeks after beginning the study , local examination revealed the signs of anal fissure epithelialization in 5 ( 45.5 % ) of the 11 patients in the study group and in 3 ( 33.3 % ) of the 9 patients in the control one .
RESULTS	At 12 weeks , fissure epithelialization and fistula obliteration were stated in 6 ( 54 % ) patients in the study group and in 3 ( 33 % ) of the 9 patients in the control group .
RESULTS	At 12 weeks , PCDAI in the study and control groups was 2.00 and 4.44 scores ( p = 0.01 ) .
CONCLUSIONS	The findings suggest that topical 0.1 % tacrolimus ointment versus antibacterial suppositories and hormone ointments is effective in treating patients with perianal CD .
CONCLUSIONS	Topical 0.1 % tacrolimus ointment therapy caused a reduction in PCDAI .

###24914089
BACKGROUND	Medication adherence is critical for transplant patients because the consequences of non-adherence can result in allograft loss and may be life threatening .
METHODS	A prospective study with 74 renal transplant recipients using a sequential control group design was performed to investigate the impact of a pharmaceutical intensified care programme led by a clinical pharmacist on daily drug adherence during the first year after renal transplantation .
METHODS	Thirty-nine patients of the control group received the already established standardized drug and transplant training , while 35 patients of the intensified care group ( ICG ) received additional inpatient and outpatient pharmaceutical care and counselling by a dedicated clinical pharmacist .
METHODS	Applied interventions were clustered and classified using the behaviour change technique taxonomy according to Michie .
METHODS	Adherence to immunosuppressive drug therapy was monitored up to 1 year using a medication event monitoring system , pill count ( PC ) , drug holiday ( DH ) occurrence , Morisky questionnaire and self-report .
RESULTS	Sixty-seven patients ( 35 of the standard care and 32 of the ICG ) were analysed .
RESULTS	Implementation of DA was significantly ( P = 0.014 ) improved in patients of the ICG ( 91 % ) compared with SCG ( 75 % ) during the first year after transplantion .
RESULTS	Daily adherence measures were already improved within 30-40 days after start of intensified patient care and continued throughout the study period .
RESULTS	Intensified care patients also showed significantly better results for taking adherence ( P = 0.006 ) , PC ( P = 0.008 ) and DHs ( P = 0.001 ) .
CONCLUSIONS	The additional , intensified pharmaceutical care improved patients ' medication adherence remarkably , suggesting that the applied additional care programme has the potential to improve outcomes after organ transplantation .

###25635970
OBJECTIVE	Postpartum hemorrhage ( PPH ) is one of the major preventable causes of maternal death in developing countries .
OBJECTIVE	Although the non-parenteral use of misoprostol is a big advantage especially in home births , its benefits in prevention of PPH is still debating .
OBJECTIVE	We aimed to assess the effect and side-effects of prophylactic oral , rectal or vaginal misoprostol on preventing postpartum hemorrhage comparing with no-treatment option .
METHODS	In a randomized clinical trial , during uncomplicated vaginal delivery , 248 women were assigned to receive one of the five treatment protocols in the third stage of labor which was managed routinely by early cord clamping and controlled cord traction .
METHODS	Maternal hemoglobin and hematocrit values , the duration of the third stage , and the incidence of blood transfusion was recorded .
RESULTS	There was no statistically significant differences between the antepartum and postpartum values of hemoglobin or hematocrit between the groups .
RESULTS	The mean duration ( 11.8 4.5 min ) of the third stage of labor in oral + vaginal group was significantly shorter .
RESULTS	Shivering was observed totally in 11 women and the differences were not significant between groups .
CONCLUSIONS	Despite misoprostol has benefit in treatment of postpartum hemorrhage , it has no remarkable effect in prophylaxis of atony-induced postpartum hemorrhage .

###24702572
OBJECTIVE	To compare femtosecond laser-assisted cataract surgery with standard phacoemulsification concerning the incidence of postoperative clinical or subclinical macular edema and the correlation between macular thickness and postoperative intraocular inflammation values .
METHODS	One hundred four eyes of 104 patients were treated by laser-assisted cataract surgery and the fellow 104 eyes underwent phacoemulsification using pulsed ultrasound energy and intraocular lens implantation in this prospective randomized study .
METHODS	Laser flare photometry was measured preoperatively and at 2 hours , 3 to 4 days , 1 month , 3 months , and 6 months postoperatively .
METHODS	Retinal thickness was measured by spectral-domain optical coherence tomography .
RESULTS	Two hundred two eyes ( 97 % ) were included and analyzed at 6 months postoperatively .
RESULTS	The mean center thickness in the laser group was 210 24 m at 4 days postoperatively , 214 22 m at 1 month postoperatively , 219 20 m at 3 months postoperatively , and 215 22 m at 6 months postoperatively .
RESULTS	The mean center thickness in the standard group was 211 32 m at 4 days postoperatively , 210 34 m at 1 month postoperatively , 217 29 m at 3 months postoperatively , and 209 30 m at 6 months postoperatively .
RESULTS	Laser flare photometry showed higher levels in the standard group at the first postoperative visit 2 hours after surgery compared with the laser group .
CONCLUSIONS	Femtosecond laser-assisted cataract surgery did not obviously influence the incidence of postoperative macular edema .

###24505200
OBJECTIVE	To evaluate the effects of a bimatoprost/timolol fixed combination ( BTFC ) and a latanoprost/timolol fixed combination ( LTFC ) on diurnal intraocular pressure ( IOP ) and anterior ocular parameters in healthy subjects .
METHODS	We enrolled 58 healthy subjects in this prospective clinical study .
METHODS	Thirty subjects were treated with BTFC and 28 subjects were treated with LTFC .
METHODS	IOP was measured every 2 hours except from 01:00 and 05:00 .
METHODS	Axial length , corneal curvature , and anterior chamber depth were obtained using the IOL master at baseline and 24 hours later .
METHODS	Adverse events were assessed by patient interview and by slit lamp examination .
RESULTS	The largest difference in IOP between treated and untreated eyes 8 hours after instillation was 1.67 mmHg in the BTFC group ( p < 0.001 ) .
RESULTS	The largest difference in IOP between treated and untreated eyes 10 hours after instillation was 1.93 mmHg in the LTFC group ( p < 0.001 ) .
RESULTS	For anterior ocular parameters such as axial length , corneal curvature , anterior chamber depth at baseline and 24 hours after instillation , there were no significant differences between the baseline and 24-hour values in either the BTFC or LTFC group .
RESULTS	The most frequently occurring adverse event was conjunctival hyperemia , which was found in 33.3 % ( n = 10 ) of the BTFC group and 25.0 % ( n = 7 ) of the LTFC group ( p = 0.486 ) .
CONCLUSIONS	BTFC and LTFC provided a significant reduction in IOP from baseline without changing any anterior ocular parameters .
CONCLUSIONS	Our results provide a reference for monocular trials to assess the effect of eye drops in a clinical condition .

###25790807
OBJECTIVE	Thiazide diuretics are reported to have antioxidant effects and reduce pulse pressure ( PP ) .
OBJECTIVE	The aim of this study was to elucidate whether hydrochlorothiazide additionally exerts such effects in stroke patients under treatment with losartan .
METHODS	This study was an open-label , randomized , multicenter study .
METHODS	Patients with a history of chronic stroke and treatment with angiotensin receptor blockers or angiotensin-converting enzyme inhibitors for essential hypertension were enrolled .
METHODS	Fifty-five hypertensive patients were randomly assigned to two groups : those further treated with hydrochlorothiazide and those further treated with non-diuretic antihypertensive drugs .
RESULTS	Both groups showed a significant decrease in PP over six months ( hydrochlorothiazide group : 6712 mmHg to 5812 , p < 0.001 ; non-diuretic group : 7212 to 6112 , p < 0.001 ) , although no significant differences were observed between the two groups .
RESULTS	The malondialdehyde-modified low-density lipoprotein levels did not change significantly after treatment in either group .
CONCLUSIONS	In this study , hydrochlorothiazide treatment did not provide any additional benefits over non-diuretic antihypertensive drugs in terms of antioxidant effects or reducing PP .

###25342738
BACKGROUND	Invasive hemodynamic exercise testing is commonly used in the evaluation of patients with suspected heart failure with preserved ejection fraction ( HFpEF ) or pulmonary hypertension .
BACKGROUND	Saline loading has been suggested as an alternative provocative maneuver , but the hemodynamic changes induced by the 2 stresses have not been compared .
RESULTS	Twenty-six subjects ( aged , 6710 years ; n = 14 HFpEF ; n = 12 control ) underwent right heart catheterization at rest , during supine exercise , and with acute saline loading in a prospective study .
RESULTS	Exercise and saline each increased cardiac output and pressures in the right atrium , pulmonary artery , and pulmonary capillary wedge positions .
RESULTS	Changes in heart rate , blood pressure , rate-pressure product , and cardiac output were greater with exercise compared with saline .
RESULTS	In controls subjects , right atrial pressure , pulmonary arterial pressure , and pulmonary capillary wedge pressure increased similarly with saline and exercise , whereas in HFpEF subjects , exercise led to 2-fold greater increases in right atrial pressure ( 104 versus 63 mm Hg ; P = 0.02 ) , pulmonary arterial pressure ( 228 versus 114 mm Hg ; P = 0.0001 ) , and pulmonary capillary wedge pressure ( 185 versus 104 mm Hg ; P < 0.0001 ) compared with saline .
RESULTS	Systolic reserve assessed by stroke work and cardiac power output was lower in HFpEF subjects with both exercise and saline .
RESULTS	Systemic and pulmonary arterial compliances were enhanced with saline but reduced with exercise .
CONCLUSIONS	Exercise elicits greater pulmonary capillary wedge pressure elevation compared with saline in HFpEF but not controls , suggesting that hemodynamic stresses beyond passive stiffness and increased venous return explain the development of pulmonary venous hypertension in HFpEF .
CONCLUSIONS	Exercise testing is more sensitive than saline loading to detect hemodynamic derangements indicative of HFpEF .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01418248 .

###24769563
OBJECTIVE	The aim of this study was to evaluate DNA damage and cytokinetic defects , proliferative potential and cell death caused by the frequent use of mouthrinses containing chlorhexidine , triclosan and essential oils in ethanolic solution , compared to a placebo mouthwash .
METHODS	This double-blind , prospective , randomized clinical trial included 80 Caucasian patients .
METHODS	Subjects were divided into four groups : Group I used a mouthrinse , Triclosan ; Group II used physiological saline ; Group III used chlorhexidine ; Group IV a mouthrinse with essential oils in ethanolic solution .
METHODS	All subjects used the mouthrinses for two weeks ( 15 ml , twice a day , rinsing for 30s ) .
METHODS	Two cell samples per subject were collected , before and after mouthrinse use ( on day 0 and day 15 ) .
METHODS	Samples were processed as follows : cell collection from cheeks with a cytobrush ; cell centrifuge ; slide preparation , fixation and staining ; and fluorescent microscope analysis .
METHODS	2000 exfoliated cells were screened for nuclear abnormalities , particularly the presence of micronuclei by means of cytome assay .
RESULTS	No significant differences between study times ( before and after use of mouthwash ) were identified for any of the variables studied ( p > 0.05 ) .
RESULTS	Differences between mouthrinse groups were also compared but no significant differences were found ( p > 0.05 ) .
CONCLUSIONS	This study did not observe any genotoxic effect resulting from mouthrinse use .

###25041141
BACKGROUND	Recent studies have shown that Gaviscon Double Action Liquid ( a combination alginate-antacid ) administered post-prandially co-localises with the acid pocket , the ` reservoir ' for post-prandial acid reflux .
OBJECTIVE	To compare the effectiveness of Gaviscon Double Action Liquid to an equivalent strength antacid without alginate in controlling post-prandial acid reflux in GERD patients .
METHODS	Fourteen GERD patients undertook two 3.5-h high-resolution manometry/pH-impedance studies during which they ate a standardised meal .
METHODS	In a double-blinded randomised crossover design they then took Gaviscon or CVS brand antacid , each with ~ 18mmol/L acid neutralising capacity .
METHODS	The primary outcome was distal oesophageal acid exposure ; secondary outcomes were number of reflux events , proximal extent of reflux , nadir pH of the refluxate , mechanism of reflux and reflux symptoms scored with a validated instrument .
RESULTS	Ten patients completed the study .
RESULTS	Gaviscon studies had significantly less distal oesophageal acid exposure and greater nadir refluxate pH in the 30-150min post-prandial period than antacid studies .
RESULTS	There were no differences in the number of reflux events ( acid or weakly acidic ) or the number of proximal reflux events ( 15-17cm above the LES ) with either study medication .
CONCLUSIONS	Gaviscon Double Action Liquid is more effective than an antacid without alginate in controlling post-prandial oesophageal acid exposure .
CONCLUSIONS	However , the number and spatial distribution of reflux events within the oesophagus are similar .
CONCLUSIONS	This suggests that Gaviscon main effectiveness relates to its co-localisation with and displacement/neutralisation of the post-prandial acid pocket , rather than preventing reflux .

###26480544
OBJECTIVE	To compare the differences of clinical effects in female patients with obesity and hyperlipidemia of yang deficiency of spleen and kidney syndrome between warm acupuncture combined with auricular acupuncture and simple warm acupuncture .
METHODS	One hundred and thirty patients were randomly divided into an observation group and a control group , 65 cases in each one .
METHODS	In the control group , acupuncture was used at Pishu ( BL 20 ) , Zhongwan ( CV 12 ) , Shenshu ( BL 23 ) , Zhongji ( CV 3 ) , Guanyuan ( CV 4 ) , Mingmen ( GV 4 ) , Taibai ( SP 3 ) , Fenglong ( ST 40 ) , etc. ; warm acupuncture was applied at Pishu ( BL 20 ) , Zhongwan ( CV 12 ) , Shenshu ( BL 23 ) and Zhongji ( CV 3 ) ; the treatment was required once every two days and for 3 months continuously .
METHODS	In the observation group , based on the treatment in the control group , thumbtack intradermal needles were embedded at auricular points , including pi ( CO13 ) , shen ( CO10 ) , pangguang ( CO9 ) , sanjiao ( CO17 ) , neifenmi ( CO18 ) , neishengzhiqi ( TF2 ) , etc. .
METHODS	Obesity indices [ body mass ( W ) , obesity degree ( A ) , body mass index ( BMI ) , body fat percentage ( F % ) ] blood lipid indices [ serum total cholesterol ( TC ) , triglyceride ( TG ) , low density lipoprotein ( LDL-C ) , high density lipoprotein ( HDL-C ) ] and clinical efficacy were observed before and after treatment in the two groups .
METHODS	Results After treatment in the two groups , the obesity indices of W , A , BMI , F % and the blood lipid levels of TC , TG , LDL-C were obviously decreased compared with those before treatment ( all P < 0.01 ) and the HDL-C levels were apparently increased than those before treatment ( both P < 0.01 ) .
METHODS	After treatment , the improvement of TC and HDL-C in the observation group was superior to that in the control group ( both P < 0.01 ) .
METHODS	The difference was not statistically significant in the aspect of improving every obesity index between two groups ( all P > .
METHODS	05 ) .
METHODS	The comprehensive total effective rate of the observation group was 95.4 % ( 62/65 ) , which was better than 84.6 % ( 55/65 ) of the control group ( P < 0.001 ) .
CONCLUSIONS	Warm acupuncture combined with auricular acupuncture and simple warm acupuncture can both benignly adjust abnormal lipid metabolism of obesity patients with hyperlipidemia , and warm acupuncture combined with auricular acupuncture are superior to simple warm acupuncture treatment on antiobesity action and improving the TC and HDL-C levels .

###24691410
BACKGROUND	Increasing cases of diabetes , a general lack of routinely operational prevention , and a long history of separating disease prevention and treatment call for immediate engagement of frontier clinicians .
BACKGROUND	This applies especially to village doctors who work in rural China where the majority of the nation 's vast population lives .
OBJECTIVE	This study aims to develop and test an online Smart Web Aid for Preventing Type 2 Diabetes ( SWAP-DM2 ) capable of addressing major barriers to applying proven interventions and integrating diabetes prevention into routine medical care .
METHODS	Development of SWAP-DM2 used evolutionary prototyping .
METHODS	The design of the initial system was followed by refinement cycles featuring dynamic interaction between development of practical and effective standardized operation procedures ( SOPs ) for diabetes prevention and Web-based assistance for implementing the SOPs .
METHODS	The resulting SOPs incorporated proven diabetes prevention practices in a synergetic way .
METHODS	SWAP-DM2 provided support to village doctors ranging from simple educational webpages and record maintenance to relatively sophisticated risk scoring and personalized counseling .
METHODS	Evaluation of SWAP-DM2 used data collected at baseline and 6-month follow-up assessment : ( 1 ) audio recordings of service encounters ; ( 2 ) structured exit surveys of patients ' knowledge , self-efficacy , and satisfaction ; ( 3 ) measurement of fasting glucose , body mass index , and blood pressure ; and ( 4 ) qualitative interviews with doctors and patients .
METHODS	Data analysis included ( 1 ) descriptive statistics of patients who received SWAP-DM2-assisted prevention and those newly diagnosed with prediabetes and diabetes ; ( 2 ) comparison of the variables assessed between baseline and follow-up assessment ; and ( 3 ) narratives of qualitative data .
RESULTS	The 17 participating village doctors identified 2219 patients with elevated diabetes risk .
RESULTS	Of these , 84.85 % ( 1885/2219 ) consented to a fasting glucose test with 1022 new prediabetes and 113 new diabetes diagnoses made within 6 months .
RESULTS	The prediabetic patients showed substantial improvement from baseline to 6-month follow-up in vegetable intake ( 17.0 % , 43/253 vs 88.7 % , 205/231 ) , calorie intake ( 1.6 % , 4/253 vs 71.4 % , 165/231 ) , leisure-time exercises ( 6.3 % , 16/253 vs 21.2 % , 49/231 ) , body weight ( mean 62.12 kg , SD 9.85 vs mean 58.33 kg , SD 9.18 ) , and body mass index ( mean 24.80 kg/m ( 2 ) , SD 3.21 vs mean 23.36 kg/m ( 2 ) , SD 2.95 ) .
RESULTS	The prediabetic patients showed improvement in self-efficacy for modifying diet ( mean 5.31 , SD 2.81 vs mean 8.53 , SD 2.25 ) , increasing physical activities ( mean 4.52 , SD 3.35 vs mean 8.06 , SD 2.38 ) , engaging relatives ( mean 3.93 , SD 3.54 vs mean 6.93 , SD 2.67 ) , and knowledge about diabetes and risks of an imbalanced diet and inadequate physical activity .
RESULTS	Most participating doctors and patients viewed SWAP-DM2 as useful and effective .
CONCLUSIONS	SWAP-DM2 is helpful to village doctors , acceptable to patients , and effective in modifying immediate determinants of diabetes at least in the short term , and may provide a useful solution to the general lack of participation in diabetes prevention by frontier clinicians in rural China .
BACKGROUND	International Standard Randomized Controlled Trial Number ( ISRCTN ) : 66772711 ; http://www.controlled-trials.com/ISRCTN66772711 .

###25795646
OBJECTIVE	To assess long-term safety and efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis ( RRMS ) .
METHODS	Patients completing FTY720 Research Evaluating Effects of Daily Oral Therapy in MS ( FREEDOMS ) were eligible for this dose-blinded , parallel-group extension study , continuing fingolimod 0.5 mg/day or 1.25 mg/day , or switching from placebo to either dose , randomized 1:1 .
METHODS	Efficacy variables included annualized relapse rate ( ARR ) , brain volume loss ( BVL ) , and confirmed disability progression ( CDP ) .
METHODS	Between-group analyses were conducted in the intent-to-treat ( ITT ) population from FREEDOMS baseline to end of study .
METHODS	Within-group analyses compared years 0-2 ( FREEDOMS ) and years 2-4 ( extension ) in the extension ITT population .
RESULTS	Of 1,272 patients ( FREEDOMS ITT population ) , 1,033 were eligible , and 920 enrolled in the extension study ( continuous-fingolimod : 0.5 mg [ n = 331 ] , 1.25 mg [ n = 289 ] ; placebo-fingolimod : 0.5 mg [ n = 155 ] , 1.25 mg [ n = 145 ] ) ; 916 formed the extension ITT population ( n = 330 ; n = 287 ; n = 154 ; n = 145 ) and 773 ( 84 % ) completed .
RESULTS	In the continuous-fingolimod groups , ARR was lower ( p < 0.0001 ) , BVL was reduced ( p < 0.05 ) , and proportionately more patients were free from 3-month CDP ( p < 0.05 ) than in a group comprising all placebo-fingolimod patients .
RESULTS	Within each placebo-fingolimod group , ARR was lower ( p < 0.001 , both ) and BVL was reduced after switching ( p < 0.01 , placebo-fingolimod 0.5 mg ) .
RESULTS	Rates and types of adverse events were similar across groups ; no new safety issues were reported .
CONCLUSIONS	Efficacy benefits of fingolimod during FREEDOMS were sustained during the extension ; ARR and BVL were reduced after switching .
METHODS	This study provides Class IV evidence that long-term fingolimod treatment is well-tolerated and reduces relapse rates , disability progression , and MRI effects in patients with RRMS .

###25604122
OBJECTIVE	This study examines neurocognitive functioning in a large , well-characterized sample of homeless adults with mental illness and assesses demographic and clinical factors associated with neurocognitive performance .
METHODS	A total of 1500 homeless adults with mental illness enrolled in the At Home Chez Soi study completed neuropsychological measures assessing speed of information processing , memory , and executive functioning .
METHODS	Sociodemographic and clinical data were also collected .
METHODS	Linear regression analyses were conducted to examine factors associated with neurocognitive performance .
RESULTS	Approximately half of our sample met criteria for psychosis , major depressive disorder , and alcohol or substance use disorder , and nearly half had experienced severe traumatic brain injury .
RESULTS	Overall , 72 % of participants demonstrated cognitive impairment , including deficits in processing speed ( 48 % ) , verbal learning ( 71 % ) and recall ( 67 % ) , and executive functioning ( 38 % ) .
RESULTS	The overall statistical model explained 19.8 % of the variance in the neurocognitive summary score , with reduced neurocognitive performance associated with older age , lower education , first language other than English or French , Black or Other ethnicity , and the presence of psychosis .
CONCLUSIONS	Homeless adults with mental illness experience impairment in multiple neuropsychological domains .
CONCLUSIONS	Much of the variance in our sample 's cognitive performance remains unexplained , highlighting the need for further research in the mechanisms underlying cognitive impairment in this population .

###24290406
BACKGROUND	Paracetamol poisoning is common worldwide .
BACKGROUND	It is treated with intravenous acetylcysteine , but the standard regimen is complex and associated with frequent adverse effects related to concentration , which can cause treatment interruption .
BACKGROUND	We aimed to ascertain whether adverse effects could be reduced with either a shorter modified acetylcysteine schedule , antiemetic pretreatment , or both .
METHODS	We undertook a double-blind , randomised factorial study at three UK hospitals , between Sept 6 , 2010 , and Dec 31 , 2012 .
METHODS	We randomly allocated patients with acute paracetamol overdose to either the standard intravenous acetylcysteine regimen ( duration 2025 h ) or a shorter ( 12 h ) modified protocol , with or without intravenous ondansetron pretreatment ( 4 mg ) .
METHODS	Masking was achieved by infusion of 5 % dextrose ( during acetylcysteine delivery ) or saline ( for antiemetic pretreatment ) .
METHODS	Randomisation was done via the internet and included a minimisation procedure by prognostic factors .
METHODS	The primary outcome was absence of vomiting , retching , or need for rescue antiemetic treatment at 2 h. Prespecified secondary outcomes included a greater than 50 % increase in alanine aminotransferase activity over the admission value .
METHODS	Analysis was by intention to treat .
METHODS	This trial is registered with ClinicalTrials.gov ( identifier NCT01050270 ) .
RESULTS	Of 222 patients who underwent randomisation , 217 were assessable 2 h after the start of acetylcysteine treatment .
RESULTS	Vomiting , retching , or need for rescue antiemetic treatment at 2 h was reported in 39 of 108 patients assigned to the shorter modified protocol compared with 71 of 109 allocated to the standard acetylcysteine regimen ( adjusted odds ratio 026 , 975 % CI 013-052 ; p < 00001 ) , and in 45 of 109 patients who received ondansetron compared with 65 of 108 allocated placebo ( 041 , 020-080 ; p = 0003 ) .
RESULTS	Severe anaphylactoid reactions were recorded in five patients assigned to the shorter modified acetylcysteine regimen versus 31 who were allocated to the standard protocol ( adjusted common odds ratio 023 , 975 % CI 012-043 ; p < 00001 ) .
RESULTS	The proportion of patients with a 50 % increase in alanine aminotransferase activity did not differ between the standard ( 9/110 ) and shorter modified ( 13/112 ) regimens ( adjusted odds ratio 060 , 975 % CI 020-183 ) ; however , the proportion was higher with ondansetron ( 16/111 ) than with placebo ( 6/111 ; 330 , 101-1072 ; p = 0024 ) .
CONCLUSIONS	In patients with paracetamol poisoning , a 12 h modified acetylcysteine regimen resulted in less vomiting , fewer anaphylactoid reactions , and reduced need for treatment interruption .
CONCLUSIONS	This study was not powered to detect non-inferiority of the shorter protocol versus the standard approach ; therefore , further research is needed to confirm the efficacy of the 12 h modified acetylcysteine regimen .
BACKGROUND	Chief Scientist Office of the Scottish Government .

###25615523
OBJECTIVE	The presence of anxiety disorders is associated with poorer alcohol use disorder treatment outcomes , but little is known about the impact of alcohol use problems on anxiety disorder treatment outcomes despite their high comorbidity .
OBJECTIVE	The current study examined the impact of alcohol use symptom severity on anxiety disorder treatment outcomes in a multi-site primary care effectiveness study of anxiety disorder treatment .
METHODS	Data came from the Coordinated Anxiety Learning and Management ( CALM ) effectiveness trial .
METHODS	Participants ( N = 1004 ) were randomized to an evidence-based anxiety intervention ( including cognitive behavioral therapy and medications ) or usual care in primary care .
METHODS	Participants completed measures of alcohol use , anxiety , and depression at baseline , 6 - , 12 - , and 18-month follow-up periods .
METHODS	Patients with alcohol dependence were excluded .
RESULTS	There were no significant moderating ( Treatment Group Alcohol Use Severity ) interactions .
RESULTS	The majority of analyses revealed no predictive effects of alcohol use severity on outcome ; however , alcohol problems at baseline were associated with somewhat higher anxiety and depression symptoms at the 18-month follow-up .
CONCLUSIONS	These data indicate that patients with alcohol problems in primary care can be effectively treated for anxiety disorders .
CONCLUSIONS	Baseline alcohol problems were associated with some poorer long-term outcomes , but this was evident across CALM and usual care .
CONCLUSIONS	These findings provide preliminary evidence that there may be no need to postpone treatment of anxiety disorders until alcohol problems are addressed , at least among those who have mild to moderate alcohol problems .
CONCLUSIONS	Replication with more severe alcohol use disorders is needed .

###24953914
OBJECTIVE	To evaluate the effectiveness of nebulized mucolytic therapy ( N-acetylcysteine ) in treatment of children with acute bronchiolitis .
METHODS	Prospective randomized , controlled study .
METHODS	Paediatric Medical Unit of the Children 's Hospital and the Institute of Child Health , Lahore , from November 2011 to April 2012 .
METHODS	All the patients aged 2 months to 24 months , with the diagnosis of acute viral bronchiolitis were enrolled in the study .
METHODS	A predesigned proforma was completed after taking parental consent .
METHODS	All eligible patients were randomly assigned to one of the two groups : group-1 received N-acetylcysteine in nebulized form , and group-2 received salbutamol as a nebulized aerosol .
METHODS	Both groups were then compared regarding their clinical improvement and duration of stay in the hospital .
METHODS	The data obtained was analyzed on the statistical software SPSS version 16 .
METHODS	Descriptive statistics were obtained by frequencies and percentages .
METHODS	Chi-square test was applied to find p-value .
RESULTS	A total of 100 patients met the inclusion criteria .
RESULTS	The mean age was 3 months .
RESULTS	On the first day of treatment , the mean clinical severity score at baseline were 5.38 2.62 in group-1 and 4.68 2.2 in group-2 .
RESULTS	At day 3 and 5 , it was 2.9 1.48 and 3.30 1.77 in group-1 and 0.88 1.08 and 1.90 1.32 in group-2 respectively .
RESULTS	The clinical severity score after N-acetylcysteine inhalation therapy was better in group-1 on the third but more so on fifth day after hospital admission .
RESULTS	The mean duration of hospitalization was 4.67 2.2 days for the whole population and it differed between the 2 groups : 4.36 1.66 days in group-1 versus 4.98 2.6 days in group-2 .
CONCLUSIONS	On the basis of improvement in clinical severity score and early discharge from the hospital , N-acetylcysteine was found to be an effective therapy in acute bronchiolitis .

###24606088
BACKGROUND	For patients with active moderate-to-severe Graves ' ophthalmopathy ( GO ) , a course of 4.5 g iv glucocorticoids ( GCs ) is the recommended therapy .
BACKGROUND	The weekly protocol is preferred because of the potential safety concerns with the daily protocol .
BACKGROUND	However , evidence for the superiority of different administration protocols is lacking .
METHODS	We conducted a prospective , randomized trial to compare the efficacy and safety of two protocols of iv 4.5 g methylprednisolone in a total of 80 patients in our institute .
METHODS	The patients were randomized to receive iv methylprednisolone weekly or daily .
METHODS	The response rate ( a composite response endpoint including lid width , soft tissue involvement , proptosis , intraocular pressure , Clinical Activity Score [ CAS ] , diplopia , and visual acuity ) was evaluated as the primary outcome , and adverse effects were recorded at each visit .
METHODS	GO-associated serum cytokines were measured .
RESULTS	We found a significantly greater response rate for the weekly protocol vs the daily protocol at the 12th week ( 76.92 vs 41.03 % ; P = .0025 ) and a similar response rate at the fourth week .
RESULTS	Seven patients on the daily protocol worsened when tapering iv methylprednisolone to oral prednisone in the fourth week .
RESULTS	Patients in both groups showed significant CAS response , and at the 12th week , patients on the weekly protocol showed a nonsignificant trend toward greater CAS response .
RESULTS	Weekly protocol showed significant prolonged retreatment-free survival .
RESULTS	Severe side effects were only observed in two cases , both of which were on the daily protocol .
RESULTS	Furthermore , we observed sustained decreased levels of serum CXCL10 in the 12th week compared to the baseline level ( P = .0009 ) in the patients on the weekly protocol .
CONCLUSIONS	The weekly protocol of iv methylprednisolone therapy is more efficient and safer than the daily protocol for patients with active moderate-to-severe GO .

###24827879
OBJECTIVE	Published data supporting the best practice for patients with atrial fibrillation ( AF ) presenting to the emergency department ( ED ) are limited .
OBJECTIVE	Our objective was to evaluate the impact of an AF clinical protocol initiated in the ED with early follow-up in a specialty AF outpatient clinic .
METHODS	This was a single-center prospective study of all consented patients with AF who were discharged from the ED through the AF clinical pathway and were then seen in the AF clinic .
METHODS	The primary endpoint was the rate of 90-day hospitalization/ED visits .
METHODS	Secondary endpoints included adherence to established AF anticoagulation guidelines , rate of thromboembolic events , quality of life , and patient satisfaction .
RESULTS	One hundred consecutive patients were enrolled in the study .
RESULTS	Within 90 days , 15 had ED visits and 4 were hospitalized , whereas none developed thromboembolic complications .
RESULTS	There were significant increases in the Atrial Fibrillation Effect on QualiTy of life survey quality of life ( 67.3 24.8 vs. 89.2 15.7 ; P < 0.001 ) and patient satisfaction ( 66.4 25.3 vs. 77.9 22.8 ; P < 0.001 ) scores from baseline to 90 days .
RESULTS	Of the 29 patients with CHADS2 score 2 , 20 ( 69 % ) were discharged from the AF clinic with oral anticoagulation .
CONCLUSIONS	We describe a novel approach to the care of patients with AF presenting to the ED .
CONCLUSIONS	Usage of the ED-initiated AF clinical pathway with early follow-up in a protocol-driven AF clinic was associated with low readmission rates , no thromboembolic complications at 90 days , improved quality of life , and high patient satisfaction .

###24938136
BACKGROUND	The role of therapy on improvement of hypsarrhythmia has not been systematically assessed .
BACKGROUND	This study was performed to assess the efficacy of oral prednisolone and intramuscular adrenocorticotrophin hormone in improving hypsarrhythmia in West syndrome .
METHODS	Children ( 2 months-2 years ) , with previously untreated West syndrome , were randomized to receive 40-60 IU every other day of intramuscular adrenocorticotrophin hormone or 40-60 mg/day of oral prednisolone for 14 days .
METHODS	Children with tuberous sclerosis were excluded .
METHODS	Improvement of hypsarrhythmia was assessed blindly using a hypsarrhythmia severity scale before and after completion of therapy .
METHODS	Adverse effects were assessed on day 14 using symptom diary .
METHODS	( Clinical trial registry identifier : SLCTR/2010/010 . )
RESULTS	From 92 newly diagnosed West syndrome infants , 48 were randomized to receive prednisolone and 44 to receive adrenocorticotrophin hormone .
RESULTS	Eighty infants completed the posttreatment evaluation according to specifications .
RESULTS	The hypsarrhythmia severity score , significantly improved with hormonal therapy for 2 weeks ( 10.45 2.65 vs 3.45 2.67 ) ; P < 0.01 .
RESULTS	When individual treatment arms were compared using mean differences in the improvement of scores , improvement in prednisolone arm ( 7.95 2.76 ) was significantly greater than that in the adrenocorticotrophin hormone arm ( 6.00 2.61 ) ; P < 0.01 .
RESULTS	Both forms of therapy were tolerated well .
RESULTS	Frequent crying , irritability , weight gain , increased appetite , and abdominal distension were more common ( but not statistically significant ) with prednisolone .
CONCLUSIONS	Hypsarrhythmia severity score improved significantly with both hormonal therapies , but this improvement was significantly better with oral prednisolone than intramuscular adrenocorticotrophin hormone .
CONCLUSIONS	This is the first ever documentation of a superior therapeutic role of oral steroids in West syndrome .

###24607303
OBJECTIVE	The aim of this study was to investigate the effect of a single dose of Brazil nuts on the inflammatory markers of healthy individuals .
METHODS	A randomized crossover study was conducted with 10 healthy individuals ( mean age 24.7 3.4 y ) .
METHODS	Each individual was tested four times regarding intake of different portions of Brazil nuts : 0 , 5 , 20 and 50 g.
METHODS	At each testing period , peripheral blood was collected before and at 1 , 3 , 6 , 9 , 24 , and 48 h after intake of nuts , as well as at 5 and 30 d after intake of various Brazil nut portions .
METHODS	Blood samples were tested for high-sensitivity to C-reactive protein , interleukin ( IL ) -1 , IL-6 , IL-10 , tumor necrosis factor ( TNF ) - , and interferon ( IFN ) - , aspartate and alanine aminotransferases , albumin , total protein , alkaline phosphatase , gamma-glutamyltransferase , urea , and creatinine .
RESULTS	Consumption of nuts did not affect biochemical parameters for liver and kidney function , indicating absence of hepatic and renal toxicity .
RESULTS	A single intake of Brazil nuts ( 20 or 50 g ) caused a significant decrease in serum IL-1 , IL-6 , TNF - , and IFN - levels ( P < 0.05 ) , whereas serum levels of IL-10 were significantly increased ( P < 0.05 ) .
CONCLUSIONS	The results indicate a long-term decrease in inflammatory markers after a single intake of large portions of Brazil nuts in healthy volunteers .
CONCLUSIONS	Therefore , the long-term effect of regular Brazil nut consumption on inflammatory markers should be better investigated .

###24888295
OBJECTIVE	We investigated the manifestations of pediatric loss of control ( LOC ) eating at different stages of pubertal development .
METHODS	Participants were a nonclinical sample of 468 youth ( 8-17 years ) .
METHODS	Physical examination determined pubertal stage .
METHODS	LOC eating and disordered eating attitudes were assessed with the Eating Disorder Examination .
METHODS	In a randomized crossover design , a subset ( n = 244 ) ate ad libitum from two test meals designed to capture normal and LOC eating .
RESULTS	There were no differences in the prevalence rates or frequency of reported LOC eating episodes across pubertal stages ( ps0 .50 ) .
RESULTS	There were , however , puberty by LOC eating interactions in disordered eating attitudes and palatable food consumption ( ps .05 ) , even after adjusting for age and body composition .
RESULTS	LOC eating was associated with elevated global disordered eating attitudes , weight concern , and shape concern in post-pubertal youth ( ps .001 ) , but not pre-pubertal youth ( ps .49 ) .
RESULTS	In late-puberty , youth with LOC eating consumed less energy from protein ( p < .001 ) and more from carbohydrate ( p = .003 ) and snack-type foods ( p = .02 ) than those without LOC eating , whereas endorsement of LOC eating in pre - or early-to-mid-puberty was not associated with differences in eating behavior ( ps0 .20 ) .
CONCLUSIONS	Findings suggest that puberty may be a critical risk period , when LOC eating behaviors in boys and girls may become accompanied by greater weight and shape concerns and more obesogenic food consumption patterns .
CONCLUSIONS	Interventions for LOC eating during pre-puberty should be evaluated to determine if they are particularly beneficial for the prevention of exacerbated eating disorder psychopathology and adverse weight outcomes .

###25220724
CONCLUSIONS	No significant differences in the number of immune aberrations were seen between children with or without severe recurrent acute otitis media ( rAOM ) ; however , subnormal values of immunological markers were found more often than expected , and 4 of the 60 children had treatment-requiring immune deficiencies .
OBJECTIVE	Minor immunologic aberrations have been reported to be more frequent in children with rAOM .
OBJECTIVE	Immune investigation is recommended in children with severe rAOM , defined as six or more AOM episodes per year .
OBJECTIVE	The purpose of this study was to describe immunological findings in young children at high risk of developing rAOM , and to relate these to the number of expected aberrations and to the presence of severe rAOM .
METHODS	A total of 109 children at risk of developing rAOM were offered immune investigation including complement function , immunoglobulins with subclasses and cellular immunity .
RESULTS	Sixty patients were tested , 31 of whom had severe rAOM and 12 of whom did not develop rAOM .
RESULTS	Low levels of IgG2 ( 27 % ) , C1q ( 31 % ) and mannan-binding lectin ( 21 % ) were found up to eight times as often as expected .
RESULTS	Although subnormal values were more frequent among children with severe rAOM , the study was too small to provide reliable evidence of any difference .
RESULTS	Four children were diagnosed with immune deficiencies that required treatment .

###24268595
BACKGROUND	It is unknown whether young adults with bipolar disorder are able to benefit from early intervention combining optimised pharmacological treatment and group psychoeducation .
BACKGROUND	The aim of the present report was to compare the effects of early intervention among patients with bipolar disorder aged 18-25 years to that of patients aged 26 years or older .
METHODS	Patients were randomised to early treatment in a specialised outpatient mood disorder clinic versus standard care .
METHODS	The primary outcome was risk of psychiatric re-hospitalisation .
RESULTS	A total of 158 patients with mania/bipolar disorder were included among whom 29 ( 18.4 % ) were between 18 and 25 years and 129 patients were 26 years or older .
RESULTS	For both age groups , the point estimate of the hazard ratio of re-hospitalisation was insignificantly decreased for patients treated in the mood disorder clinic versus standard treatment but more so for patients between 18 and 25 years ( HR 0.33 , 95 % CI 0.10-1 .07 ; p = 0.064 ) than for patients 26 years or older ( HR 0.68 , 95 % CI 0.40-1 .14 , p = 0.14 ) .
RESULTS	Younger adults treated in the mood disorder clinic used mood stabilisers and antipsychotics more in contrast to those treated in standard care .
RESULTS	The differences between the estimates of effects did not reach significance in tests of interactions ( p > 0.2 ) .
CONCLUSIONS	The study was based on a post hoc subgroup analysis and due to the small number of patients aged 18-25 years , type II errors can not be excluded .
CONCLUSIONS	Although not statistically different , the observed differences of the point estimates was surprisingly larger for young adults suggesting that young adults with bipolar disorder may benefit even more than older adults from early intervention combining pharmacological treatment and group psychoeducation .

###25921377
OBJECTIVE	Antidepressants are frequently prescribed to treat functional dyspepsia ( FD ) , a common disorder characterized by upper abdominal symptoms , including discomfort or postprandial fullness .
OBJECTIVE	However , there is little evidence of the efficacy of these drugs in patients with FD .
OBJECTIVE	We performed a randomized , double-blind , placebo-controlled trial to evaluate the effects of antidepressant therapy on symptoms , gastric emptying ( GE ) , and meal-induced satiety in patients with FD .
METHODS	We performed a study at 8 North American sites of patients who met the Rome II criteria for FD and did not have depression or use antidepressants .
METHODS	Patients ( n = 292 ; 44 15 years old , 75 % were female , 70 % with dysmotility-like FD , and 30 % with ulcer-like FD ) were randomly assigned to groups given placebo , 50 mg amitriptyline , or 10 mg escitalopram for 10 weeks .
METHODS	The primary end point was adequate relief of FD symptoms for 5 weeks of the last 10 weeks ( of 12 ) .
METHODS	Secondary end points included GE time , maximum tolerated volume in Nutrient Drink Test , and FD-related quality of life .
RESULTS	An adequate relief response was reported by 39 subjects given placebo ( 40 % ) , 51 given amitriptyline ( 53 % ) , and 37 given escitalopram ( 38 % ) ( P = .05 , after treatment , adjusted for baseline balancing factors including all subjects ) .
RESULTS	Subjects with ulcer-like FD given amitriptyline were > 3-fold more likely to report adequate relief than those given placebo ( odds ratio = 3.1 ; 95 % confidence interval : 1.1-9 .0 ) .
RESULTS	Neither amitriptyline nor escitalopram appeared to affect GE or meal-induced satiety after the 10-week period in any group .
RESULTS	Subjects with delayed GE were less likely to report adequate relief than subjects with normal GE ( odds ratio = 0.4 ; 95 % confidence interval : 0.2-0 .8 ) .
RESULTS	Both antidepressants improved overall quality of life .
CONCLUSIONS	Amitriptyline , but not escitalopram , appears to benefit some patients with FD , particularly those with ulcer-like ( painful ) FD .
CONCLUSIONS	Patients with delayed GE do not respond to these drugs .
CONCLUSIONS	ClinicalTrials.gov ID : NCT00248651 .

###24814583
BACKGROUND	Infectious complications and especially anastomotic leakage ( AL ) severely impede the recuperation of patients following colorectal cancer ( CRC ) surgery .
BACKGROUND	When the normal gut barrier fails , as in AL , pathogenic microorganisms can enter the circulation and may cause severe sepsis which is associated with substantial mortality .
BACKGROUND	Moreover , AL has a negative impact on the CRC prognosis .
BACKGROUND	Selective decontamination of the digestive tract ( SDD ) employs oral nonabsorbable antibiotics to eradicate pathogenic microorganisms before elective tumour resection .
METHODS	In this multicentre randomised clinical trial , perioperative SDD in addition to standard antibiotic prophylaxis is compared with standard antibiotic prophylaxis alone in patients with CRC who undergo elective surgical resection with a curative intent .
METHODS	The SDD regimen consists of colistin , tobramycin and amphotericin B.
METHODS	The primary objectives of this randomised clinical trial are to evaluate if perioperative SDD reduces the incidence of clinical AL and its septic consequences as well as other infectious complications .
METHODS	A main secondary objective is improvement of the cancer-free survival .
METHODS	A total of 762 patients will be included in total for sufficient power .
CONCLUSIONS	It is hypothesised that SDD will reduce clinical AL thereby reducing the morbidity and the mortality in CRC patients .
BACKGROUND	The trial is investigator-initiated , investigator-driven and supported by the Dutch Digestive Foundation ( WO 11-06 ) and the private Posthumus Meyes Fund .
BACKGROUND	The trial is registered at ClinicalTrials.gov : NCT01740947 .

###24439929
BACKGROUND	Afatinib-an oral irreversible ErbB family blocker-improves progression-free survival compared with pemetrexed and cisplatin for first-line treatment of patients with EGFR mutation-positive advanced non-small-cell lung cancer ( NSCLC ) .
BACKGROUND	We compared afatinib with gemcitabine and cisplatin-a chemotherapy regimen widely used in Asia-for first-line treatment of Asian patients with EGFR mutation-positive advanced NSCLC .
METHODS	This open-label , randomised phase 3 trial was done at 36 centres in China , Thailand , and South Korea .
METHODS	After central testing for EGFR mutations , treatment-naive patients ( stage IIIB or IV cancer [ American Joint Committee on Cancer version 6 ] , performance status 0-1 ) were randomly assigned ( 2:1 ) to receive either oral afatinib ( 40 mg per day ) or intravenous gemcitabine 1000 mg/m ( 2 ) on day 1 and day 8 plus cisplatin 75 mg/m ( 2 ) on day 1 of a 3-week schedule for up to six cycles .
METHODS	Randomisation was done centrally with a random number-generating system and an interactive internet and voice-response system .
METHODS	Randomisation was stratified by EGFR mutation ( Leu858Arg , exon 19 deletions , or other ; block size three ) .
METHODS	Clinicians and patients were not masked to treatment assignment , but the independent central imaging review group were .
METHODS	Treatment continued until disease progression , intolerable toxic effects , or withdrawal of consent .
METHODS	The primary endpoint was progression-free survival assessed by independent central review ( intention-to-treat population ) .
METHODS	This study is registered with ClinicalTrials.gov , NCT01121393 .
RESULTS	910 patients were screened and 364 were randomly assigned ( 242 to afatinib , 122 to gemcitabine and cisplatin ) .
RESULTS	Median progression-free survival was significantly longer in the afatinib group ( 110 months , 95 % CI 97-137 ) than in the gemcitabine and cisplatin group ( 56 months , 51-67 ; hazard ratio 028 , 95 % CI 020-039 ; p < 00001 ) .
RESULTS	The most common treatment-related grade 3 or 4 adverse events in the afatinib group were rash or acne ( 35 [ 146 % ] of 239 patients ) , diarrhoea ( 13 [ 54 % ] ) , and stomatitis or mucositis ( 13 [ 54 % ] ) , compared with neutropenia ( 30 [ 265 % ] of 113 patients ) , vomiting ( 22 [ 195 % ] ) , and leucopenia ( 17 [ 150 % ] ) in the gemcitabine and cisplatin group .
RESULTS	Treatment-related serious adverse events occurred in 15 ( 63 % ) patients in the afatinib group and nine ( 80 % ) patients in the gemcitabine and cisplatin group .
CONCLUSIONS	First-line afatinib significantly improves progression-free survival with a tolerable and manageable safety profile in Asian patients with EGFR mutation-positive advanced lung NSCLC .
CONCLUSIONS	Afatinib should be considered as a first-line treatment option for this patient population .
BACKGROUND	Boehringer Ingelheim .

###25133492
OBJECTIVE	Physical inactivity and advanced age are associated with risk of depressive disorders .
OBJECTIVE	Physical activity can reduce depressive symptoms in older subjects with depressive disorders .
OBJECTIVE	We investigated whether a walking intervention program may decrease the occurrence of depressive symptoms in inactive post-menopausal women without depression .
METHODS	A total of 121 participants aged 57-75 years were randomly assigned to a six-month moderate intensity walking intervention ( three times a week , 40 minutes per session , supervised and home-based ) or to a control group ( waiting list ) .
METHODS	Inactivity was assessed using the Physical Activity Questionnaire for the Elderly .
METHODS	Depression levels were measured pre - and post-intervention with the Beck depression inventory ( BDI ) .
METHODS	Several baseline measures were considered as possible predictors of post-intervention BDI score .
RESULTS	Participants in the walking intervention showed a significant decrease in depression as compared with controls .
RESULTS	Baseline cognitive-BDI subscore , subjective health status , body mass index and adherence were post-intervention BDI score predictors .
CONCLUSIONS	A six-month , three-session per week , moderate intensity walking intervention with a minimal 50 % adherence rate reduces depression in post-menopausal women at risk for depression due to physical inactivity .
CONCLUSIONS	This type of walking intervention could be considered as a widely accessible prevention strategy to prevent depressive symptoms in post-menopausal women at risk of depression .

###24815533
OBJECTIVE	The purpose of this study was to evaluate the efficacy and safety of duloxetine fixed dose in the treatment of children ( 7-11 years ) and adolescents ( 12-17 years ) with major depressive disorder ( MDD ) .
METHODS	Patients ( n = 463 ) in this 36 week study ( 10 week acute and 26 week extension treatment ) received duloxetine 60mg QD ( n = 108 ) , duloxetine 30mg QD ( n = 116 ) , fluoxetine 20mg QD ( n = 117 , active control ) , or placebo ( n = 122 ) .
METHODS	Measures included : Children 's Depression Rating Scale-Revised ( CDRS-R ) , treatment-emergent adverse events ( TEAEs ) , and Columbia-Suicide Severity Rating Scale ( C-SSRS ) .
RESULTS	Neither active drug ( duloxetine or fluoxetine ) separated significantly ( p < 0.05 ) from placebo on mean change from baseline to end-point ( 10 weeks ) on the CDRS-R total score .
RESULTS	Total TEAEs and discontinuation for AEs were significantly ( p < 0.05 ) higher only for the duloxetine 60mg group versus the placebo group during acute treatment .
RESULTS	No clinically significant electrocardiogram ( ECG ) or laboratory abnormalities were observed , and no completed suicides or deaths occurred during the study .
RESULTS	A total of 7 ( 6.7 % ) duloxetine 60mg , 6 ( 5.2 % ) duloxetine 30mg , 9 ( 8.0 % ) fluoxetine , and 11 ( 9.4 % ) placebo patients had worsening of suicidal ideation from baseline during acute treatment .
RESULTS	Of the patients with suicidal ideation at baseline , 13/16 ( 81 % ) duloxetine 60mg , 16/17 ( 94 % ) duloxetine 30mg , 11/16 ( 69 % ) fluoxetine , and 13/15 ( 87 % ) placebo had improvement in suicidal ideation at end-point during acute treatment .
RESULTS	One fluoxetine , one placebo , and six duloxetine patients had treatment-emergent suicidal behavior during the 36 week study .
CONCLUSIONS	Trial results were inconclusive , as neither the investigational drug ( duloxetine ) nor the active control ( fluoxetine ) separated from placebo on the CDRS-R at 10 weeks .
CONCLUSIONS	No new duloxetine safety signals were identified relative to those seen in adults .
CONCLUSIONS	Clinical Trial Registry Number ( www.ClinicalTrials.gov ) : NCT00849693 .

###24880577
OBJECTIVE	The aim of this study was to evaluate early complications following retromuscular mesh repair with those after dual layer suture of the anterior rectus sheath in a randomised controlled clinical trial for abdominal rectus muscle diastasis ( ARD ) .
METHODS	Patients with an ARD wider than 3 cm and clinical symptoms related to the ARD were included in a prospective randomised study .
METHODS	They were assigned to either retromuscular inset of a lightweight polypropylene mesh or to dual closure of the anterior rectus fascia using Quill self-locking technology .
METHODS	All patients completed a validated questionnaire for pain assessment ( Ventral Hernia Pain Questionnaire , VHPQ ) and for quality of life ( SF36 ) prior to and 3 months after surgery .
RESULTS	The most frequently seen adverse event was minor wound infection .
RESULTS	Of the patients , 14/57 had a superficial wound infection ; five related to Quill and nine to mesh repair .
RESULTS	No deep wound infections were reported .
RESULTS	Patient rating for subjective muscular improvement postoperatively was better in the mesh technique group with a mean of 6.9 ( range 0-10 ) compared to a mean of 4.8 ( range 0-10 ) in the Quill group ( p = 0.01 ) .
RESULTS	The pre - and post-operative SF36 scores improved in both groups .
CONCLUSIONS	There was no significant difference between the two surgical techniques in terms of early complications and perceived pain at the 3-month follow-up .
CONCLUSIONS	Both techniques may be considered equally reliable for ARD repair in terms of adverse outcomes during the early postoperative phase , even though patients operated with a mesh experienced better improvement in muscular strength .
CONCLUSIONS	ClinicalTrial.gov : 2009/227 -31 / 3/PE/96 .

###25815419
OBJECTIVE	The study aims were 1 ) to describe the proportions of individuals who met criteria for melancholic , atypical , and anxious depressive subtypes , as well as subtype combinations , in a large sample of depressed outpatients , and 2 ) to compare subtype profiles on remission and change in depressive symptoms after acute treatment with one of three antidepressant medications .
METHODS	Participants 18-65 years of age ( N = 1,008 ) who met criteria for major depressive disorder were randomly assigned to 8 weeks of treatment with escitalopram , sertraline , or extended-release venlafaxine .
METHODS	Participants were classified by subtype .
METHODS	Those who met criteria for no subtype or multiple subtypes were classified separately , resulting in eight mutually exclusive groups .
METHODS	A mixed-effects model using the intent-to-treat sample compared the groups ' symptom score trajectories , and logistic regression compared likelihood of remission ( defined as a score 5 on the 16-item Quick Inventory of Depressive Symptomatology-Self-Report ) .
RESULTS	Thirty-nine percent of participants exhibited a pure-form subtype , 36 % met criteria for more than one subtype , and 25 % did not meet criteria for any subtype .
RESULTS	All subtype groups exhibited a similar significant trajectory of symptom reduction across the trial .
RESULTS	Likelihood of remission did not differ significantly between subtype groups , and depression subtype was not a moderator of treatment effect .
CONCLUSIONS	There was substantial overlap of the three depressive subtypes , and individuals in all subtype groups responded similarly to the three antidepressants .
CONCLUSIONS	The consistency of these findings with those of the Sequenced Treatment Alternatives to Relieve Depression trial suggests that subtypes may be of minimal value in antidepressant selection .

###24450889
BACKGROUND	Tuberculosis is epidemic among workers in South African gold mines .
BACKGROUND	We evaluated an intervention to interrupt tuberculosis transmission by means of mass screening that was linked to treatment for active disease or latent infection .
METHODS	In a cluster-randomized study , we designated 15 clusters with 78,744 miners as either intervention clusters ( 40,981 miners in 8 clusters ) or control clusters ( 37,763 miners in 7 clusters ) .
METHODS	In the intervention clusters , all miners were offered tuberculosis screening .
METHODS	If active tuberculosis was diagnosed , they were referred for treatment ; if not , they were offered 9 months of isoniazid preventive therapy .
METHODS	The primary outcome was the cluster-level incidence of tuberculosis during the 12 months after the intervention ended .
METHODS	Secondary outcomes included tuberculosis prevalence at study completion .
RESULTS	In the intervention clusters , 27,126 miners ( 66.2 % ) underwent screening .
RESULTS	Of these miners , 23,659 ( 87.2 % ) started taking isoniazid , and isoniazid was dispensed for 6 months or more to 35 to 79 % of miners , depending on the cluster .
RESULTS	The intervention did not reduce the incidence of tuberculosis , with rates of 3.02 per 100 person-years in the intervention clusters and 2.95 per 100 person-years in the control clusters ( rate ratio in the intervention clusters , 1.00 ; 95 % confidence interval [ CI ] , 0.75 to 1.34 ; P = 0.98 ; adjusted rate ratio , 0.96 ; 95 % CI , 0.76 to 1.21 ; P = 0.71 ) , or the prevalence of tuberculosis ( 2.35 % vs. 2.14 % ; adjusted prevalence ratio , 0.98 ; 95 % CI , 0.65 to 1.48 ; P = 0.90 ) .
RESULTS	Analysis of the direct effect of isoniazid in 10,909 miners showed a reduced incidence of tuberculosis during treatment ( 1.10 cases per 100 person-years among miners receiving isoniazid vs. 2.91 cases per 100 person-years among controls ; adjusted rate ratio , 0.42 ; 95 % CI , 0.20 to 0.88 ; P = 0.03 ) , but there was a subsequent rapid loss of protection .
CONCLUSIONS	Mass screening and treatment for latent tuberculosis had no significant effect on tuberculosis control in South African gold mines , despite the successful use of isoniazid in preventing tuberculosis during treatment .
CONCLUSIONS	( Funded by the Consortium to Respond Effectively to the AIDS TB Epidemic and others ; Thibela TB Current Controlled Trials number , ISRCTN63327174 . )

###24330619
BACKGROUND	Our main objective was to evaluate the ability of cranberry phytochemicals to modify immunity , specifically - T cell proliferation , after daily consumption of a cranberry beverage , and its effect on health outcomes related to cold and influenza symptoms .
METHODS	The study was a randomized , double-blind , placebo-controlled , parallel intervention .
METHODS	Subjects drank a low calorie cranberry beverage ( 450 ml ) made with a juice-derived , powdered cranberry fraction ( n = 22 ) or a placebo beverage ( n = 23 ) , daily , for 10 wk .
METHODS	PBMC were cultured for six days with autologous serum and PHA-L stimulation .
METHODS	Cold and influenza symptoms were self-reported .
RESULTS	The proliferation index of - T cells in culture was almost five times higher after 10 wk of cranberry beverage consumption ( p < 0.001 ) .
RESULTS	In the cranberry beverage group , the incidence of illness was not reduced , however significantly fewer symptoms of illness were reported ( p = 0.031 ) .
CONCLUSIONS	Consumption of the cranberry beverage modified the ex vivo proliferation of - T cells .
CONCLUSIONS	As these cells are located in the epithelium and serve as a first line of defense , improving their function may be related to reducing the number of symptoms associated with a cold and flu .

###24699298
BACKGROUND	Neonates at risk for early-onset sepsis are started on antibiotics empirically .
BACKGROUND	Antibiotic resistance to conventionally used antibiotics is increasingly being reported .
BACKGROUND	Antenatal maternal antibiotic exposure in this setting contributes to low yield on blood culture drawn at birth , limiting the planning of antibiotics based on culture reports .
BACKGROUND	A head-to-head comparison for selecting the appropriate antibiotic is one strategy .
OBJECTIVE	To compare monotherapy with amikacin against piperacillin-tazobactum as an empirical therapy in neonates at risk for early-onset sepsis .
METHODS	Randomized open-label controlled trial with stratification and block randomization .
METHODS	Tertiary care neonatal unit in India
METHODS	All consecutive inborn neonates delivered between 01 May 2009 and 30 April 2011 who were 28 week gestation and/or 1000 g birth weight with risk factors for early-onset sepsis .
METHODS	Randomized to receive either amikacin or piperacillin-tazobactum , after stratifying as asymptomatic or symptomatic within 1 h of birth .
METHODS	Incidence of treatment failure to the allocated antibiotic defined as blood culture isolate reported resistant to the allocated antibiotic or progression of the illness , necessitating a change of antibiotic .
RESULTS	Of 204 eligible cases , 187 were enrolled .
RESULTS	Seventeen babies were excluded .
RESULTS	A total of 128 neonates were stratified as asymptomatic and 59 as symptomatic .
RESULTS	In all , 64 of the asymptomatic cases received amikacin and 64 received piperacillin-tazobactum , while 29 symptomatic babies received amikacin and 30 received piperacillin-tazobactum .
RESULTS	Five babies had blood culture-positive sepsis , and 28 babies had strong suspicion of sepsis .
RESULTS	There was no difference in the treatment failure in the amikacin group ( 3 of 93 ; 3.2 % ) compared with piperacillin-tazobactum group ( 2 of 94 ; 2.1 % ) ( p > 0.01 ) and no difference in the incidence of second infection , fungal sepsis and all-cause mortality at day 7 and 28 between the two study groups ( p > 0.01 ) .
CONCLUSIONS	Monotherapy with amikacin as an empirical antibiotic did not result in a higher incidence of treatment failure in neonates at risk for early-onset sepsis as compared with piperacillin-tazobactum .
CONCLUSIONS	Both antibiotics were effective in management of babies with early-onset sepsis .

###24251363
BACKGROUND	The level of anticoagulation in response to a fixed-dose regimen of warfarin is difficult to predict during the initiation of therapy .
BACKGROUND	We prospectively compared the effect of genotype-guided dosing with that of standard dosing on anticoagulation control in patients starting warfarin therapy .
METHODS	We conducted a multicenter , randomized , controlled trial involving patients with atrial fibrillation or venous thromboembolism .
METHODS	Genotyping for CYP2C9 * 2 , CYP2C9 * 3 , and VKORC1 ( -1639 GA ) was performed with the use of a point-of-care test .
METHODS	For patients assigned to the genotype-guided group , warfarin doses were prescribed according to pharmacogenetic-based algorithms for the first 5 days .
METHODS	Patients in the control ( standard dosing ) group received a 3-day loading-dose regimen .
METHODS	After the initiation period , the treatment of all patients was managed according to routine clinical practice .
METHODS	The primary outcome measure was the percentage of time in the therapeutic range of 2.0 to 3.0 for the international normalized ratio ( INR ) during the first 12 weeks after warfarin initiation .
RESULTS	A total of 455 patients were recruited , with 227 randomly assigned to the genotype-guided group and 228 assigned to the control group .
RESULTS	The mean percentage of time in the therapeutic range was 67.4 % in the genotype-guided group as compared with 60.3 % in the control group ( adjusted difference , 7.0 percentage points ; 95 % confidence interval , 3.3 to 10.6 ; P < 0.001 ) .
RESULTS	There were significantly fewer incidences of excessive anticoagulation ( INR 4.0 ) in the genotype-guided group .
RESULTS	The median time to reach a therapeutic INR was 21 days in the genotype-guided group as compared with 29 days in the control group ( P < 0.001 ) .
CONCLUSIONS	Pharmacogenetic-based dosing was associated with a higher percentage of time in the therapeutic INR range than was standard dosing during the initiation of warfarin therapy .
CONCLUSIONS	( Funded by the European Commission Seventh Framework Programme and others ; ClinicalTrials.gov number , NCT01119300 . )

###24421289
OBJECTIVE	Subjective response to alcohol represents a marker of alcoholism risk .
OBJECTIVE	The A118G single-nucleotide polymorphism ( SNP ) of the mu opioid receptor ( OPRM1 ) gene has been associated with subjective response to alcohol .
OBJECTIVE	Recently , the dopamine transporter ( DAT1 ) variable number of tandem repeat ( VNTR ; SLC6A3 ) has been found to interact with the OPRM1 A118G SNP in predicting neural and behavioral responses to naltrexone and to alcohol .
OBJECTIVE	This exploratory study examines the OPRM1 DAT1 interaction on subjective responses to alcohol .
METHODS	Non-treatment-seeking problem drinkers ( n = 295 ) were assessed in the laboratory for alcohol dependence .
METHODS	Following prospective genotyping for the OPRM1 gene , 43 alcohol-dependent individuals were randomized to two intravenous infusion sessions , one of alcohol ( target BrAC = 0.06 g/dl ) and one of saline .
METHODS	Measures of subjective responses to alcohol were administered in both infusion sessions .
RESULTS	Analyses revealed significant Alcohol OPRM1 DAT1 interactions for alcohol-induced stimulation , vigor and positive mood as well as significant Alcohol OPRM1 DAT1 Time interactions for stimulation and positive mood .
RESULTS	These effects were such that , compared with other genotype groups , OPRM1 G-allele carriers + DAT1 A10 homozygotes reported steeper increases in stimulation and positive mood across rising BrAC , when compared with placebo .
RESULTS	All Alcohol OPRM1 DAT1 interactions remained significant when analyses were restricted to a subsample of Caucasian participants ( n = 34 ) ; however , 4-way interactions did not reach statistical significance in this subsample .
CONCLUSIONS	This study suggests that the contribution of OPRM1 genotype to alcohol-induced stimulation , vigor and positive mood is moderated by DAT1 genotype .
CONCLUSIONS	These findings are consistent with the purported interaction between opioidergic and dopaminergic systems in determining the reinforcing properties of alcohol .

###24630296
OBJECTIVE	Women with late preterm premature rupture of membranes ( PROM ) have an increased risk that their child will develop neonatal sepsis .
OBJECTIVE	We evaluated whether neonatal sepsis can be predicted from antepartum parameters in these women .
METHODS	We used multivariable logistic regression to develop a prediction model .
METHODS	Data were obtained from two recent randomized controlled trials on induction of labor versus expectant management in late preterm PROM ( PPROMEXIL trials , ( ISRCTN29313500 and ISRCTN05689407 ) .
METHODS	Data from randomized as well as non-randomized women , who consented to the use of their medical data , were used .
METHODS	We evaluated 13 potential antepartum predictors for neonatal sepsis .
METHODS	Missing data were imputed .
METHODS	Discriminative ability of the model was expressed as the area under the receiver operating characteristic ( ROC ) curve and a calibration with both a calibration plot and the Hosmer and Lemeshow goodness-of-fit test .
METHODS	Overall performance of the prediction model was quantified as the scaled Brier score .
RESULTS	We studied 970 women .
RESULTS	Thirty-three ( 3.4 % ) neonates suffered neonatal sepsis .
RESULTS	Maternal age ( OR 1.09 per year ) , maternal CRP level ( OR 1.01 per mmol/l ) , maternal temperature ( OR 1.80 per C ) and positive GBS culture ( OR 2.20 ) were associated with an increased risk of neonatal sepsis .
RESULTS	The model had an area under the ROC-curve of 0.71 .
RESULTS	The model had both a good calibration and accuracy .
CONCLUSIONS	Antepartum parameters aid in the more precise prediction of the risk of neonatal sepsis in women with late preterm PPROM .

###24534763
BACKGROUND	The Canadian Fabry disease initiative ( CFDI ) tracks outcomes of subjects with Fabry disease treated enzyme replacement therapy ( ERT ) given to subjects who meet evidence-based treatment guidelines and cardiovascular risk factor modification .
METHODS	We report 5 year follow-up data on 362 subjects for a composite endpoint ( death , neurologic or cardiovascular events , development of end-stage renal disease or sustained increase in serum creatinine of 50 % from baseline ) .
RESULTS	At enrollment , 86 subjects had previously received ERT ( Cohort 1a ) and 67 subjects were newly started ( Cohort 1b ) and randomized to agalsidase alfa or agalsidase beta .
RESULTS	209 subjects did not initially meet ERT criteria ( Cohort 1c ) , 25 of whom met ERT criteria in follow-up and were moved to Cohort 1b ( total N = 178 ERT treated subjects ) .
RESULTS	Use of supportive therapies such as aspirin ( 78 % ) , renin-angiotensin blockade ( 59 % ) , and statins ( 55 % ) was common in ERT treated subjects .
RESULTS	In Cohort 1a , 32 subjects met the composite endpoint with 8 deaths .
RESULTS	In Cohort 1b , 16 subjects met the composite endpoint with 1 death .
RESULTS	Cohort 1b had fewer clinical events than Cohort 1a ( p = 0.039 ) suggesting that the treatment protocol was effective in targeting subjects at an earlier stage .
RESULTS	19.4 % of Cohort 1b subjects on agalsidase alfa and 13.3 % on agalsidase beta had a clinical event ( p = 0.57 ) .
RESULTS	10 Cohort 1c subjects had clinical events , none of which would have been prevented by earlier use of ERT .
CONCLUSIONS	Cardiovascular risk factor modification and targeted use of ERT reduce the risk of adverse outcomes related to Fabry disease .

###25066875
OBJECTIVE	Prostate capsule sparing and nerve sparing cystectomies are alternative procedures for bladder cancer that may decrease morbidity while achieving cancer control .
OBJECTIVE	However , to our knowledge the comparative effectiveness of these approaches has not been established .
OBJECTIVE	We evaluated functional and oncologic outcomes in patients undergoing these procedures .
METHODS	We performed a single institution trial in patients with bladder cancer in whom transurethral prostatic urethral biopsy and transrectal prostate biopsy were negative .
METHODS	Men were randomized to prostate capsule sparing or nerve sparing cystectomy with neobladder creation and stratified by Sexual Health Inventory for Men score ( greater than 21 vs 21 or less ) .
METHODS	Our primary end point was 12-month overall urinary function as measured by Bladder Cancer Index .
METHODS	Secondary end points included sexual function , cancer control and complications .
RESULTS	A total of 40 patients were enrolled in the study with 20 patients in each arm .
RESULTS	Urinary function at 12 months decreased by 13 and 28 points in the prostate capsule and nerve sparing groups , respectively ( p = 0.10 ) .
RESULTS	Sexual function followed a similar pattern ( p = 0.06 ) .
RESULTS	There was no difference in recurrence-free , metastasis-free or overall survival ( each p > 0.05 ) .
RESULTS	The rate of incidentally detected prostate cancer was similar ( p = 0.15 ) .
CONCLUSIONS	Our study provides a randomized comparison of prostate capsule sparing and nerve sparing cystectomy techniques .
CONCLUSIONS	We found no difference in functional or oncologic outcomes between the 2 approaches , although our study was underpowered due to a lack of patient accrual .

###24682463
OBJECTIVE	Following the demonstrated efficacy and safety of eribulin mesylate in heavily pretreated patients with metastatic breast cancer , an exploratory analysis was performed to investigate the effect of age in these patients .
METHODS	Data were pooled from two single-arm phase II studies and one open-label randomized phase III study in which patients received eribulin mesylate at 1.4 mg/m ( 2 ) as 2 - to 5-minute intravenous infusions on days 1 and 8 of a 21-day cycle .
METHODS	The effect of age on median overall survival ( OS ) , progression-free survival ( PFS ) , overall response rate ( ORR ) , clinical benefit rate ( CBR ) , and incidence of adverse events ( AEs ) was calculated for four age groups ( < 50 years , 50-59 years , 60-69 years , 70 years ) .
METHODS	RESULTS .
METHODS	Overall , 827 patients were included in the analysis ( < 50 years , n = 253 ; 50-59 years , n = 289 ; 60-69 years , n = 206 ; 70 years , n = 79 ) .
METHODS	Age had no significant impact on OS ( 11.8 months , 12.3 months , 11.7 months , and 12.5 months , respectively ; p = .82 ) , PFS ( 3.5 months , 2.9 months , 3.8 months , and 4.0 months , respectively ; p = .42 ) , ORR ( 12.7 % , 12.5 % , 6.3 % , and 10.1 % , respectively ) , or CBR ( 20.2 % , 20.8 % , 20.4 % , and 21.5 % , respectively ) .
METHODS	Although some AEs had higher incidence in either the youngest or the oldest subgroup , there was no overall effect of age on the incidence of AEs ( including neuropathy , neutropenia , and leukopenia ) .
CONCLUSIONS	Eribulin monotherapy in these selected older patients with good baseline performance status led to OS , PFS , ORR , CBR , and tolerability similar to those of younger patients with metastatic breast cancer .
CONCLUSIONS	The benefits and risks of eribulin appear to be similar across age groups .

###24359313
OBJECTIVE	To evaluate the efficacy , tolerability , and safety of once-daily 1200 mg and 2400 mg SPN-804 ( Oxtellar XR , Supernus Pharmaceuticals ) , an extended-release tablet formulation of oxcarbazepine ( OXC ) , added to 1-3 concomitant antiepileptic drugs ( AEDs ) in adults with refractory partial-onset seizures , with or without secondary generalization .
METHODS	The Prospective , Randomized Study of OXC XR in Subjects with Partial Epilepsy Refractory ( PROSPER ) study was a multinational , randomized , double-blind , parallel-group Phase 3 study .
METHODS	The primary efficacy endpoint was median percent reduction from baseline in monthly ( 28-day ) seizure frequency for the 16-week double-blind treatment period in the intent-to-treat ( ITT ) population with analyzable seizure data .
METHODS	Other efficacy analyses included proportion of patients with 50 % seizure reduction , proportion of patients seizure free , and the relationship between clinical response and plasma concentration .
RESULTS	Median percent reduction was -28.7 % for placebo , -38.2 % ( P = 0.08 vs placebo ) for once-daily SPN-804 1200 mg , and -42.9 % ( P = 0.003 ) for SPN-804 2400 mg .
RESULTS	Responder rates were 28.1 % , 36.1 % ( P = 0.08 ) , and 40.7 % ( P = 0.02 ) ; 16-week seizure-free rates in a pragmatic ITT analysis were 3.3 % , 4.9 % ( P = 0.59 ) , and 11.4 % ( P = 0.008 ) , respectively .
RESULTS	When data were analyzed separately for study site clusters , a post hoc analysis demonstrated that both SPN-804 dosages were significantly superior to placebo in median percent seizure reduction ( placebo : -13.3 % ; 1200 mg : -34.5 % , P = 0.02 ; 2400 mg : -52.7 % , P = 0.006 ) in the North American study site cluster .
RESULTS	A concentration-response analysis also supported a clinically meaningful effect for 1200 mg .
RESULTS	Adverse event types reflected the drug 's established profile .
RESULTS	Adverse event frequency was consistent with a pharmacokinetic profile in which SPN-804 produces lower peak plasma concentrations vs immediate-release OXC .
RESULTS	Once-daily dosing was not associated with any new safety signals .
CONCLUSIONS	Adjunctive once-daily SPN-804 improved seizure control in patients with inadequately controlled partial-onset seizures .
CONCLUSIONS	Adverse event occurrence and discontinuations due to adverse events suggest improved tolerability vs previously published data with immediate-release OXC .

###24767892
BACKGROUND	Few studies examine the helpfulness and effectiveness of substance abuse treatment from the clients ' perspective .
METHODS	The current secondary analysis examined the perceived helpfulness of substance abuse treatment components and its relationship to treatment outcomes among 387 Black and White adults participating in a multisite randomized clinical trial ( RCT ) of Motivational Enhancement Therapy .
METHODS	Throughout the 16-week RCT , participants self-reported substance use .
METHODS	Upon completion of treatment , participants completed a self-report measure assessing the perceived helpfulness of treatment components .
RESULTS	Black participants rated 9 out of 12 treatment components ( e.g. , `` learning skills that will help me cope with my problems '' ) as being more helpful than their White counterparts , even after controlling for age , gender , employment status , primary drug type , and treatment assignment .
RESULTS	However , perceived helpfulness ratings were not associated with substance use outcomes among Black or White participants .
CONCLUSIONS	Clients ' perceived helpfulness of treatment components is an important factor to consider in improving the delivery of substance abuse treatment , especially for Black adults .

###24593836
OBJECTIVE	To evaluate the direct effects of periodontal therapy in Chronic Obstructive Pulmonary Disease ( COPD ) patients with chronic periodontitis ( CP ) .
METHODS	In a pilot randomized controlled trial , 60 COPD patients with CP were randomly assigned to receive scaling and root planing ( SRP ) treatment , supragingival scaling treatment , or oral hygiene instructions only with no periodontal treatment .
METHODS	We evaluated their periodontal indexes , respiratory function , and COPD exacerbations at baseline , 6months , 1 , and 2years .
RESULTS	Compared with the control group , measurements of periodontal indexes were significantly improved in patients in two treatment groups at 6-month , 1-year , and 2-year follow-up ( all p < 0.05 ) .
RESULTS	Overall , the means of forced expiratory volume in the first second/forced vital capacity ( FEV1/FVC ) and FEV1 were significantly higher in the two therapy groups compared with the control group during the follow-up ( p < 0.05 ) .
RESULTS	In addition , the frequencies of COPD exacerbation were significantly lower in the two therapy groups than in the control group at 2-year follow-up ( p < 0.05 ) .
CONCLUSIONS	Our preliminary results from this pilot trial suggest that periodontal therapy in COPD patients with CP may improve lung function and decrease the frequency of COPD exacerbation .

###25731215
OBJECTIVE	Arterial punctures are important procedures performed by emergency physicians in the assessment of ill patients .
OBJECTIVE	However , arterial punctures are painful and can create anxiety and needle phobia in patients .
OBJECTIVE	The pain score of radial arterial punctures were compared between the insulin needle and the standard 23-gauge hypodermic needle .
METHODS	In a randomized controlled crossover design , healthy volunteers were recruited to undergo bilateral radial arterial punctures .
METHODS	They were assigned to receive either the insulin or the standard needle as the first puncture , using blocked randomization .
METHODS	The primary outcome was the pain score measured on a 100-mm visual analogue scale ( VAS ) for pain , and secondary outcomes were rate of hemolysis , mean potassium values , and procedural complications immediately and 24 hours postprocedure .
RESULTS	Fifty healthy volunteers were included in the study .
RESULTS	The mean ( standard deviation ) VAS score in punctures with the insulin needle was lower than the standard needle ( 23 22 mm vs. 39 24 mm ; mean difference = -15 mm ; 95 % confidence interval = -22 mm to -7 mm ; p < 0.001 ) .
RESULTS	The rates of hemolysis and mean potassium value were greater in samples obtained using the insulin needle compared to the standard needle ( 31.3 % vs. 11.6 % , p = 0.035 ; and 4.6 0.7 mmol/L vs. 4.2 0.5 mmol/L , p = 0.002 ) .
RESULTS	Procedural complications were lower in punctures with the insulin needle both immediately postprocedure ( 0 % vs. 24 % ; p < 0.001 ) and at 24 hours postprocedure ( 5.4 % vs. 34.2 % ; p = 0.007 ) .
CONCLUSIONS	Arterial punctures using insulin needles cause less pain and fewer procedural complications compared to standard needles .
CONCLUSIONS	However , due to the higher rate of hemolysis , its use should be limited to conditions that do not require a concurrent potassium value in the same blood sample .

###24598216
BACKGROUND	Remifentanil is widely used for monitored anesthesia care in spontaneously breathing patients .
BACKGROUND	However , the authors ' previous studies have shown that remifentanil induces subjective swallowing difficulties , which may increase the risk of aspiration .
METHODS	Twenty-five healthy volunteers participated in a double-blind , randomized , crossover trial at the University Hospital in rebro , rebro , Sweden .
METHODS	The volunteers were studied on two different occasions during which they received either remifentanil with an effect-site target concentration of 3 ng/ml or saline over 1 h.
METHODS	A radionuclide tracer was infused simultaneously into the nasopharynx at a rate of 0.1 ml/min .
METHODS	Aspiration was determined by lung scans , and subjective swallowing difficulties and grip strength were evaluated .
METHODS	The primary outcome was the difference in occurrence of aspiration between remifentanil and placebo treatments .
METHODS	The secondary outcomes were differences in swallowing difficulty and grip strength and the association between aspiration and swallowing difficulty .
RESULTS	During remifentanil and placebo infusion , 48 and 12 % of the volunteers aspirated , respectively , difference : 36 % ( 95 % CI , 10 to 62 % ) .
RESULTS	A similar significant difference was found for swallowing difficulties but not for the association between aspiration and swallowing .
RESULTS	No difference was found in grip strength between the two treatments .
CONCLUSIONS	Remifentanil infusion at concentrations used in monitored anesthesia care increases the incidence of aspiration .
CONCLUSIONS	However , the subjective swallowing difficulty induced by remifentanil is not indicative of the aspiration risk .

###25777546
OBJECTIVE	Vitamin D modulates the immune response and blocks induction of an interferon ( IFN ) signature by systemic lupus erythematosus ( SLE ) sera .
OBJECTIVE	This study was undertaken to investigate the effects of vitamin D supplementation on the IFN signature in patients with SLE .
METHODS	SLE patients ( n = 57 ) with stable , inactive disease , a serum 25-hydroxyvitamin D ( 25 [ OH ] D ) level 20 ng/ml , an elevated anti-double-stranded DNA antibody level , and an IFN signature ( as determined by measuring the expression levels of 3 IFN response genes ) were randomized into a 12-week double-blind , placebo-controlled trial of vitamin D3 at doses of 2,000 IU or 4,000 IU .
METHODS	An IFN signature response was defined as a 50 % reduction in the expression of 1 of the 3 genes or a 25 % reduction in the expression of 2 of the 3 genes .
METHODS	Disease activity , adverse events , and endocrine effects were assessed .
RESULTS	Baseline characteristics of the patients in the 3 treatment groups ( placebo , low-dose vitamin D3 , or high-dose vitamin D3 ) were similar .
RESULTS	Repletion of 25 ( OH ) D ( i.e. , levels 30 ng/ml ) was not observed in any of the patients who were receiving placebo , while repletion was observed in 16 of 33 patients receiving vitamin D3 .
RESULTS	The percentage of patients with an IFN signature response did not differ among the treatment groups .
RESULTS	Moreover , there was no difference in the percentage of patients with an IFN signature response between those who remained vitamin D deficient and those who demonstrated repletion of vitamin D. Modular microarray analysis of a subset of patients ( n = 40 ) did not reveal changes from baseline in any modules ( including the IFN-inducible module ) in any of the treatment groups , and no differences in expression were found between patients who demonstrated vitamin D repletion and patients who were persistently vitamin D deficient .
RESULTS	Vitamin D3 was well tolerated , and there were no safety concerns .
CONCLUSIONS	Vitamin D3 supplementation up to 4,000 IU daily was safe and well-tolerated but failed to diminish the IFN signature in vitamin D-deficient SLE patients .
CONCLUSIONS	Higher 25 ( OH ) D levels sustained for a longer duration may be required to affect immunologic outcomes .

###24612524
BACKGROUND	Distal radius fractures are among the most common fractures seen in the hospital emergency department .
BACKGROUND	Of these , over 40 % are considered unstable and require some form of fixation .
BACKGROUND	In recent years with the advent of low profile plating , open reduction and internal fixation ( ORIF ) using volar plates has become the surgical treatment of choice in many hospitals .
BACKGROUND	However , it is currently unknown which plating system has the lowest complication rate and/or superior clinical and radiological outcomes following surgery .
BACKGROUND	Few studies have compared different types of plates , which may have various features , different plate and screw designs or may be manufactured from different materials ( for example , stainless steel or titanium ) .
BACKGROUND	This study will specifically investigate and compare the clinical and radiological outcomes and complication rates of two commonly used volar plating systems for fixation of distal radius fractures : one made from stainless steel ( Trimed Volar Plate , Trimed , California , USA ) and the other made from titanium ( Medartis Aptus Volar Plate , Medartis , Basel , Switzerland ) .
BACKGROUND	The primary aim of this study is to determine if there is a difference on the Patient Reported Wrist Evaluation six months following ORIF using a volar plate for adult patients with a distal radius fracture .
METHODS	This study will implement a randomized prospective clinical trial study design evaluating the outcomes of two different types of volar plates : one plate manufactured from stainless steel ( Trimed Volar Plate ) and one plate manufactured from titanium ( Medartis Aptus Volar Plate ) .
METHODS	The surgery will be performed at a major trauma hospital in Brisbane , Australia .
METHODS	Outcome measures including function , adverse events , range of movement , strength , disability , radiological findings and health-related quality of life will be collected at 6 weeks , 3 , 6 , 12 and 24 months following surgery .
METHODS	A parallel economic analysis will also be performed .
METHODS	This randomized clinical trial is due to deliver results in December 2016 .
CONCLUSIONS	Results from this trial will contribute to the evidence on operative management of distal radius fractures and plate material type .
BACKGROUND	ACTRN12612000969864 .

###25178805
OBJECTIVE	To compare corneal sensation and self-reported dry eye symptoms after femtosecond-assisted LASIK with conventional versus inverted side cuts .
METHODS	Prospective , randomized , eye-to-eye study .
METHODS	A total of 120 eyes in 60 participants with myopia .
METHODS	Fellow eyes were randomized to receive femtosecond-assisted LASIK with a conventional 70-degree side cut made with the 60 kHz IntraLase FS ( Abbott Medical Optics , Santa Ana , CA ) or an inverted 130-degree side cut made with the 150 kHz IntraLase iFS ( Abbott Medical Optics ) .
METHODS	Cochet-Bonnet aesthesiometry ( Luneau Ophthalmologia , Chartes , France ) measured corneal sensation ( 60 mm = normal sensation ; < 60 mm = depressed sensation ) preoperatively and at postoperative months 1 , 3 , 6 , and 12 .
METHODS	Participants also completed serial dry eye surveys using the same subscales ( frequency , severity , bothersome ) as the validated , Rasch-tested , linear-scaled Quality of Vision questionnaire .
METHODS	Objective corneal sensation and self-reported light sensitivity , dryness , foreign body sensation , and pain/discomfort .
RESULTS	Preoperative corneal sensation as measured by mean Cochet-Bonnet aethesiometry was equal between the inverted and conventional side cut groups but was better in eyes with an inverted side cut compared with a conventional side cut at all postoperative months ( inverted vs. conventional : 1 month , 14.5 vs. 13.2 mm ; 3 months , 24.9 vs. 18.4 mm ; 6 months , 51.2 vs. 42.6 mm ; 12 months , 59.8 vs. 58.3 mm ; all P 0.02 ) .
RESULTS	None of the subjective dry eye parameters demonstrated statistically significant differences between the groups at any time point .
CONCLUSIONS	The LASIK flaps with an inverted side cut are associated with superior recovery of corneal sensation compared with flaps with a conventional side cut during the first postoperative year ; however , this may not translate to significant improvements in subjective dry eye symptoms .

###24457061
OBJECTIVE	This trial was designed to compare levonorgestrel intrauterine device ( LNG-IUD ) use at 1 year after delivery between women randomized to postplacental insertion at the time of cesarean delivery and delayed insertion 4-8 weeks after delivery .
METHODS	This randomized controlled trial was conducted at two urban medical centers .
METHODS	Eligible pregnant women with planned cesarean deliveries were randomized to immediate postplacental insertion during cesarean or delayed insertion after 4-8 weeks .
METHODS	We used intention-to-treat analysis for the primary outcome of LNG-IUD use 12 months after delivery .
RESULTS	Forty-two women were randomized , 20 into the postplacental group and 22 in the delayed group .
RESULTS	Although confirmed use of the LNG-IUD 12 months after delivery was higher in the postplacental group ( 60.0 % vs. 40.9 % , p = .35 ) , this difference was not statistically significance .
RESULTS	Expulsion was significantly more common in the postplacental group ( 20.0 % vs. 0 % , p = .04 ) .
RESULTS	There were significant differences between the two sites in baseline population characteristics , follow-up and expulsion .
RESULTS	The trial did not answer the intended question as it was halted early due to slow enrollment .
CONCLUSIONS	Our results show higher expulsion after postplacental insertion compared to delayed insertion but suggest similar IUD use at 12 months .
CONCLUSIONS	Moreover , it provides valuable lessons regarding a randomized controlled trial of postplacental LNG-IUD placement due to the challenges of estimating effect size and the nature of the population who might benefit from immediate insertion .
CONCLUSIONS	Postplacental insertion of an IUD may improve use of highly effective contraception during the postpartum period .
CONCLUSIONS	While our results suggest higher expulsion after postplacental insertion compared to delayed insertion and similar IUD use at 12 months , our trial was insufficient to definitively test our hypothesis .

###25448243
OBJECTIVE	To investigate the effect of adding segmental epidural steroid injections ( SESIs ) to usual care compared with usual care alone on quality of life and cost utility in lumbosacral radicular syndrome ( LRS ) in general practice .
METHODS	A pragmatic randomized controlled trial .
METHODS	Results were analyzed using mixed models .
METHODS	Primary care .
METHODS	Patients ( N = 50 ) in the acute phase of LRS .
METHODS	One epidural injection containing 80mg of triamcinolone in normal saline .
METHODS	Back pain at 4 weeks after the start of the treatment .
RESULTS	Both groups experienced a significant increase in quality of life in ( especially ) the physical domains of the Medical Outcomes Study 36-Item Short-Form Health Survey .
RESULTS	The intervention group scored significantly better than the control group at certain time points in the physical domain .
RESULTS	The differences were small .
RESULTS	The cost-utility analysis showed that with a negligible loss of utility ( 3d in perfect health ) , societal costs ( 193,354 euros per quality-adjusted life year lost ) would be saved because of more productivity in the intervention group .
CONCLUSIONS	Although the beneficial effects of SESIs are small and the natural course of LRS is predominantly favorable , we think decision makers can consider implementing SESIs in daily practice with the purpose of saving resources .
CONCLUSIONS	Caution must be taken , and further research should be directed at identifying patient subgroups who might benefit from SESIs , with additional focus on ( costs of ) complications and adverse effects .

###25352208
BACKGROUND	To test the hypothesis that a semi-quantitative echocardiographic calcium score ( eCS ) significantly correlates with cardiac calcium measured by coronary computed tomography angiography ( CCTA ) and , secondarily , severe coronary artery calcifications and stenosis .
METHODS	This is a retrospective , observational study , conducted in a tertiary centre .
METHODS	eCS was compared with CCTA scores of non-coronary cardiac calcium ( nCACS ) , coronary cardiac calcium ( CACS ) and number of diseased coronary vessels , in 141 subjects without known coronary artery disease ( CAD ) , who underwent both echocardiography and CCTA for clinical reasons .
RESULTS	Age , prevalence of hypertension and all measures of calcium ( eCS , nCACS and CACS ) differed significantly between the no-CAD and CAD subgroups .
RESULTS	eCS was positively correlated with nCACS ( Spearman rho = 0.64 , p < 0.0001 ) , CACS ( rho = 0.46 , p < 0.01 ) and weakly with the number of diseased coronary vessels ( rho = 0.28 , p < 0.05 ) .
RESULTS	eCS and nCACS had similar area under the curve ( AUC ) for the prediction of severe CACS ( 400 ) ( 0.77 , 95 % CI 0.68-0 .86 and 0.79 , 95 % CI 0.72-0 .88 ) or obstructive CAD ( 0.63 , 95 % CI 0.54-0 .72 and 0.63 , 95 % CI 0.55-0 .73 ) .
CONCLUSIONS	eCS , a calcium score easily obtainable during standard echocardiography , is moderately to strongly correlated with nCACS by CCTA .
CONCLUSIONS	The full eCS score correlates with nCACS better than its single components .
CONCLUSIONS	It correlates with CACS and predicts severe coronary calcification ( CACS > 400 ) , a known predictor of cardiovascular morbidity and mortality .
CONCLUSIONS	The eCS also predicts obstructive CAD , incrementally to age and clinical variables , although for this purpose CACS remains the most accurate score .

###24655465
OBJECTIVE	As young women from certain ethnic minority groups have reported less pursuit of the thin ideal and body dissatisfaction than European American young women we tested whether a dissonance-based prevention program designed to reduce thin-ideal internalization among women with body dissatisfaction is less effective for the former relative to the later groups .
OBJECTIVE	We also tested whether intervention effects are larger when participants from minority groups worked with a facilitator matched versus not matched on ethnicity .
METHODS	In Study 1 , 426 female undergraduates ( M age = 21.6 , SD = 5.6 ) were randomized to clinician-led Body Project groups or an educational control group .
METHODS	In Study 2 , 189 female undergraduates were randomized to peer-led Body Project groups or a waitlist control condition .
RESULTS	Although there was some variation in risk factor scores across ethnic groups , ethnic minority participants did not demonstrate consistently higher or lower risk relative to European American participants .
RESULTS	Intervention effects did not significantly differ for participants from minority groups versus European American participants in either trial .
RESULTS	There was no evidence that effects were significantly larger when minority participants and facilitators were matched on ethnicity .
CONCLUSIONS	Results suggest that the Body Project is similarly effective for African American , Asian American , European American , and Hispanic female college students , and when participants and facilitators are matched or not on minority ethnicity status , implying that this prevention program can be broadly disseminated in this population .

###24658769
OBJECTIVE	There are no data regarding management and outcomes of major bleeding events in patients treated with oral factor Xa inhibitors .
RESULTS	Using data from ROCKET AF , we analysed the management and outcomes of major bleeding overall and according to the randomized treatment .
RESULTS	During a median follow-up of 1.9 years , 779 ( 5.5 % ) patients experienced major bleeding at a rate of 3.52 events/100 patient-years with a similar event rate in each arm ( n = 395 rivaroxaban vs. n = 384 warfarin ) .
RESULTS	The median number of transfused packed red blood cells ( PRBC ) per episode was similar in both arms [ 2 ( 25th , 75th : 2 , 4 ) units ] .
RESULTS	Overall , few transfusions of whole blood ( n = 14 ) , platelets ( n = 10 ) , or cryoprecipitate ( n = 2 ) were used .
RESULTS	Transfusion of fresh frozen plasma ( FFP ) was significantly less in the rivaroxaban arm ( n = 45 vs. n = 81 units ) after adjustment for covariates [ odds ratio ( OR ) 0.43 ( 95 % CI 0.29-0 .66 ) ; P < 0.0001 ] .
RESULTS	Prothrombin complex concentrates ( PCC ) were administered less in the rivaroxaban arm ( n = 4 vs. n = 9 ) .
RESULTS	Outcomes after major bleeding , including stroke or non-central nervous system embolism ( 4.7 % rivaroxaban vs. 5.4 % warfarin ; HR 0.89 ; 95 % CI 0.42-1 .88 ) and all-cause death ( 20.4 % rivaroxaban vs. 26.1 % warfarin ; HR 0.69 , 95 % CI 0.46-1 .04 ) were similar in patients treated with rivaroxaban and warfarin ( interaction P = 0.51 and 0.11 ) .
CONCLUSIONS	Among high-risk patients with atrial fibrillation who experienced major bleeding in ROCKET AF , the use of FFP and PCC was less among those allocated rivaroxaban compared with warfarin .
CONCLUSIONS	However , use of PRBCs and outcomes after bleeding were similar among patients randomized to rivaroxaban or to warfarin .

###24371264
BACKGROUND	Remote ischemic preconditioning ( RIPC ) has been suggested to induce cardioprotection during cardiac surgery .
BACKGROUND	Maintaining proper atrial function is imperative in preventing arrhythmia and thrombus formation .
BACKGROUND	Mitochondria have been proposed as key targets in conveying RIPC mechanisms and effects .
BACKGROUND	MicroRNA ( miR ) is emerging as an important regulator of mitochondrial function , arrhythmia , and protection from ischemia and reperfusion .
OBJECTIVE	This study aimed to evaluate the effect of RIPC on mitochondrial respiration and miR expression in human atrial tissue .
RESULTS	Sixty patients undergoing coronary artery bypass graft surgery were randomized to RIPC ( n = 30 ) or control ( n = 30 ) .
RESULTS	RIPC was performed preoperatively by inflating a blood pressure cuff on the upper arm to 200 mm Hg for 35 minutes , with 5 minutes reperfusion intervals .
RESULTS	Biopsies were obtained from the right atrial appendage before and after aortic cross-clamping .
RESULTS	Mitochondrial respiration was measured in situ and miR assessed by commercial miR array and quantitative reverse transcription polymerase chain reaction .
RESULTS	Postoperative atrial fibrillation occurrence was monitored by biotelemetry .
RESULTS	Maximal mitochondrial respiration was preserved throughout surgery after RIPC but significantly reduced ( -28 % ; P < 0.05 ) after aortic cross-clamping in control .
RESULTS	Incidence of postoperative atrial fibrillation was lower after RIPC versus control ( 14 % versus 50 % ; P < 0.01 ) .
RESULTS	Myocardial expression of miR-133a and miR-133b increased after aortic cross-clamping in both RIPC and control , whereas miR-1 was upregulated in control only .
RESULTS	MiR-338-3p expression was higher in RIPC versus control after aortic cross-clamping .
CONCLUSIONS	RIPC preserves mitochondrial respiration and prevents upregulation of miR-1 in the right atrium during coronary artery bypass graft .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01308138 .

###25048810
OBJECTIVE	Providing different programs of occupational health services in the same company is difficult .
OBJECTIVE	We report the results of a parallel randomized trial for the employees of our company for visceral fat measurements and the effect of a weight loss support web system .
METHODS	181 healthy employees with BMI over 23 who volunteered to participate in this study .
METHODS	In a parallel randomized study , we divided them into 3 groups ( A , health guidance by occupational health staff with visceral fat measurements and a weight loss support web system ; B , health guidance by occupational health staff with a weight loss support web system ; C , without health guidance ( control ) ) by date of birth .
METHODS	To assess the effects of guidance and support , we compared each group 's waist circumference ( WC ) , weight , and BMI , before and after the guidance .
METHODS	We also conducted questionnaire surveys of eating behavior and life activities before and after the guidance to estimate the relationship between the intervention method used for each group and their behavioral modification .
RESULTS	150 employees ( 83 % ) finished this program .
RESULTS	Within 3 months , reduction in the outcome measures was largest in group A , and showed significant differences from the other two groups .
RESULTS	For many employees in group A , eating behavior factors improved markedly ; however , in the control group , there were no changes in eating behavior or daily living activities .
CONCLUSIONS	A parallel randomized trial involving the employees of our company was performed and we scientifically verified the effects of an occupational health programs .
CONCLUSIONS	Objective study of occupational health activities and measures were enabled by devising methods and procedures , e.g. , applying the waiting-list method for the control group .
CONCLUSIONS	This approach will lead to appropriate selection and precise implementation of evidence-based measures in occupational health in the future .

###25670542
OBJECTIVE	This paper reports long-term results of RTOG 9903 , to determine whether the addition of erythropoietin ( EPO ) would improve the outcomes of radiation therapy ( RT ) in mildly to moderately anemic patients with head and neck squamous cell carcinoma ( HNSCCa ) .
METHODS	The trial included HNSCCa patients treated with definitive RT. .
METHODS	Patients with stage III or IV disease received concomitant chemoradiation therapy or accelerated fractionation .
METHODS	Pretreatment hemoglobin levels were required to be between 9.0 and 13.5 g/dL ( 12.5 g/dL for females ) .
METHODS	EPO , 40,000 U , was administered weekly starting 7 to 10days before RT was initiated in the RT+EPO arm .
RESULTS	A total of 141 of 148 enrolled patients were evaluable .
RESULTS	The baseline median hemoglobin level was 12.1 g/dL .
RESULTS	In the RT+EPO arm , the mean hemoglobin level at 4weeks increased by 1.66 g/dL , whereas it decreased by 0.24 g/dL in the RT arm .
RESULTS	With a median follow-up of 7.95 years ( range : 1.66-10 .08 years ) for surviving patients and 3.33 years for all patients ( range : 0.03-10 .08 years ) , the 5-year estimate of local-regional failure was 46.2 % versus 39.4 % ( P = .42 ) , local-regional progression-free survival was 31.5 % versus 37.6 % ( P = .20 ) , and overall survival was 36.9 % versus 38.2 % ( P = .54 ) for the RT+EPO and RT arms , respectively .
RESULTS	Late toxicity was not different between the 2 arms .
CONCLUSIONS	This long-term analysis confirmed that despite the ability of EPO to raise hemoglobin levels in anemic patients with HNSCCa , it did not improve outcomes when added to RT. .
CONCLUSIONS	The possibility of a detrimental effect of EPO could not be ruled out .

###24304724
BACKGROUND	To define protein molecular characteristics of tumor cells prior to , and immediately following , preoperative human epidermal growth factor receptor 2 ( HER2 ) - targeted therapy that correlate with pathologic complete response ( pCR ) or non response ( no pCR ) to preoperative HER2-directed therapy and chemotherapy .
METHODS	This open-label , phase II study randomized patients with HER2-positive stage II or III invasive breast cancer to trastuzumab , lapatinib , or both , 2 weeks prior to and during chemotherapy with FEC75 for 4 courses ; then paclitaxel 80 mg/m2 weekly for 12 courses , then surgery .
METHODS	Core needle biopsies were collected at baseline and after 2 weeks of anti-HER2 therapy prior to chemotherapy .
METHODS	Data were correlated with pCR , defined as absence of invasive tumor in breast and lymph nodes .
RESULTS	Of 100 enrolled patients , the analysis population included those who had surgery and received 75 % chemotherapy ( 78 % [ n = 78 ] ) .
RESULTS	pCRs by arm are : trastuzumab ( n = 26 ) , 54 % [ n = 14 ] ; lapatinib ( n = 29 ) , 45 % [ n = 13 ] ; trastuzumab plus lapatinib ( n = 23 ) , 74 % [ n = 17 ] ) .
RESULTS	Paired biopsy specimens were available for 49 patients ( 63 % ) .
RESULTS	Tumor cells of patients with pCR in the trastuzumab or lapatinib treatment arms showed nonphosphorylated FOXO , phosphorylated Stat5 , and sparse signal-transduction protein network crosstalk representing different patterns of connections with PI3K and autophagy proteins compared with no pCR .
CONCLUSIONS	In this exploratory study , pCR with preoperative anti-HER2 therapy and chemotherapy correlated with the levels and phosphorylation status of specific baseline signal pathway proteins in tumor cells .
CONCLUSIONS	These data may provide candidate biomarkers to stratify initial treatment and potential combination therapies for future study .
CONCLUSIONS	Tissue preservation technology introduced here makes this procedure widely feasible .
BACKGROUND	ClinicalTrials.gov : NCT00524303 .

###24826958
OBJECTIVE	To investigate the feasibility and effectiveness of conducting two positive psychology interventions to improve mood and self-concept with survivors of traumatic brain injury ( TBI ) , within a neuro-rehabilitation hospital .
METHODS	Ten patients with brain injury were randomly allocated to an intervention and control group .
METHODS	The efficacy of the first intervention , ` three positive things in life ' was measured via Seligman 's Authentic Happiness Index ( AHI ) , at base-line , directly following the intervention and at the end of the 12-week group programme .
METHODS	The second intervention , the ` Value in Action ( VIA ) signature strengths intervention ' was measured by the Head Injury Semantic Differential Scale ( HISDS ) at baseline and at the end of the group .
RESULTS	Compared to baseline and control group scores , the AHI index showed an increase in the intervention group 's happiness following the intervention and at the end of the 12-week programme , albeit the latter increase was non-significant .
RESULTS	The HISDS showed non-significant improvement in self-concept and reduction in polarization of the self in the present , future and past in the second intervention .
RESULTS	Anecdotal evidence revealed a clear improved mood following the interventions .
CONCLUSIONS	This study shows promising results for the effectiveness of Positive Psychology interventions and methods to improve feasibility when applying this treatment within a hospital setting .

###25841237
BACKGROUND	The optimal use of various therapeutic combinations for moderate/severe chronic obstructive pulmonary disease ( COPD ) is unclear .
BACKGROUND	The GLISTEN trial compared the efficacy of two long-acting anti-muscarinic antagonists ( LAMA ) , when combined with an inhaled corticosteroid ( ICS ) and a long-acting 2 agonist ( LABA ) .
METHODS	This randomised , blinded , placebo-controlled trial in moderate/severe COPD patients compared once-daily glycopyrronium ( GLY ) 50g , once-daily tiotropium ( TIO ) 18g or placebo ( PLA ) , when combined with salmeterol/fluticasone propionate ( SAL/FP ) 50/500g twice daily .
METHODS	The primary objective was to determine the non-inferiority of GLY+SAL / FP versus TIO+SAL / FP on trough FEV1 after 12weeks .
METHODS	An important secondary objective was whether addition of GLY to SAL/FP was better than SAL/FP alone .
RESULTS	773 patients ( mean FEV1 57.2 % predicted ) were randomised ; 84.9 % completed the trial .
RESULTS	At week 12 , GLY+SAL / FP demonstrated non-inferiority to TIO+SAL / FP for trough FEV1 : least square mean treatment difference ( LSMdiff ) -7 mL ( SE 17.4 ) with a lower limit for non-inferiority of -60 mL .
RESULTS	There was significant increase in week 12 trough FEV1 with GLY+SAL / FP versus PLA+SAL / FP ( LSMdiff 101mL , p < 0.001 ) .
RESULTS	At 12weeks , GLY+SAL / FP produced significant improvement in St George 's Respiratory Questionnaire total score versus PLA+SAL / FP ( LSMdiff -2.154 , p = 0.02 ) .
RESULTS	GLY+SAL / FP demonstrated significant rescue medication reduction versus PLA+SAL / FP ( LSMdiff -0.72 puffs/day , p < 0.001 ) .
RESULTS	Serious adverse events were similar for GLY+SAL / FP , TIO+SAL / FP and PLA+SAL / FP with an incidence of 5.8 % , 8.5 % and 5.8 % , respectively .
CONCLUSIONS	GLY+SAL / FP showed comparable improvements in lung function , health status and rescue medication to TIO+SAL / FP .
CONCLUSIONS	Importantly , addition of GLY to SAL/FP demonstrated significant improvements in lung function , health status and rescue medication compared to SAL/FP .
BACKGROUND	NCT01513460 .

###25578926
BACKGROUND	There is a need for culturally relevant nutrition programs targeted to underserved cancer survivors .
OBJECTIVE	Our aim was to examine the effect of a culturally based approach to dietary change on increasing fruit/vegetable ( F/V ) intake and decreasing fat intake among Hispanic breast cancer survivors .
METHODS	Participants were randomized to Intervention and Control groups .
METHODS	Diet recalls , detailed interviews , fasting blood , and anthropometric measures were collected at baseline , 3 , 6 , and 12 months .
METHODS	Hispanic women ( n = 70 ) with stage 0 to III breast cancer who completed adjuvant treatment and lived in New York City were randomized between April 2011 and March 2012 .
METHODS	The Intervention group ( n = 34 ) participated in Cocinar Para Su Salud !
METHODS	, a culturally based nine-session ( 24 hours over 12 weeks ) intervention including nutrition education , cooking classes , and food-shopping field trips .
METHODS	The Control group ( n = 36 ) received written dietary recommendations for breast cancer survivors .
METHODS	Change at 6 months in daily F/V servings and percent calories from total fat were the main outcome measures .
METHODS	Linear regression models adjusted for stratification factors and estimated marginal means were used to compare changes in diet from baseline to 3 and 6 months .
RESULTS	Baseline characteristics were the following : mean age 56.6 years ( standard deviation 9.7 years ) , mean time since diagnosis 3.4 years ( standard deviation 2.7 years ) , mean body mass index ( calculated as kg/m ) 30.9 ( standard deviation 6.0 ) , 62.9 % with annual household income $ 15,000 , mean daily servings of all F/V was 5.3 ( targeted F/V 3.7 servings excluding legumes/juices/starchy vegetables/fried foods ) , and 27.7 % of daily calories from fat .
RESULTS	More than 60 % in the Intervention group attended seven or more of nine classes , with overall study retention of 87 % retention at 6 months .
RESULTS	At month 6 , the Intervention group compared with Control group reported an increase in mean servings of F/V from baseline ( all F/V : +2.0 vs -0.1 ; P = 0.005 ; targeted F/V : +2.7 vs +0.5 ; P = 0.002 ) and a nonsignificant decrease in percent calories from fat ( -7.5 % vs -4.4 % ; P = 0.23 ) and weight ( -2.5 kg vs +3.8 kg ; P = 0.22 ) .
CONCLUSIONS	Cocinar Para Su Salud !
CONCLUSIONS	was effective at increasing short-term F/V intake in a diverse population of Hispanic breast cancer survivors .

###24968886
OBJECTIVE	Copeptin , a quantitative marker of endogenous stress , seems to provide incremental value in addition to cardiac troponin in the early rule-out of acute myocardial infarction ( AMI ) .
OBJECTIVE	Prevalence , characteristics and outcome of acute chest pain patients with causes other than AMI and elevated copeptin are poorly understood .
METHODS	A total of 984 consecutive patients with non-cardiac chest pain were selected from a prospective multicentre study of acute chest pain patients presenting to the emergency department .
METHODS	Levels of copeptin were determined in a blinded fashion and considered elevated if above 13pmol/L ( the 97,5 th centile of healthy individuals ) .
METHODS	The final diagnosis was adjudicated by two independent cardiologists .
METHODS	Median duration of follow-up was 756days .
RESULTS	Elevated copeptin levels were seen in 215 patients ( 22 % ) .
RESULTS	In comparison to patients with normal copeptin levels , patients with elevated levels were older , had more pre-existing cardiac and non-cardiac disorders , more silent cardiomyocyte injury and increased haemodynamic stress as quantified by levels of high-sensitivity cardiac troponin T ( 9.6 ng/L ( 3.6-18 .3 ) vs 5.8 ng/L ( 2.9-9 .4 ) ) and B-type natriuretic peptide ( 75ng/L ( 37-187 ) vs 35ng/L ( 15-77 ) ) ( both p < 0.001 ) , more electrocardiographic abnormalities , more often an adjudicated diagnosis of gastroesophageal reflux or bronchitis/pneumonia and higher 2-year mortality ( HR 2.9 , 95 % CI 1.5 to 5.7 ) .
RESULTS	The increased mortality rate seemed to be largely explained by age and comorbidities .
CONCLUSIONS	Elevated levels of copeptin are present in about one in five patients with non-cardiac chest pain and are associated with aging , cardiac and non-cardiac comorbidities as well as mortality .

###24660645
OBJECTIVE	This study investigated the efficacy of low-level laser therapy ( LLLT ) for the management of temporomandibular joint ( TMJ ) osteoarthritis .
METHODS	In a double-blind clinical trial , 20 patients with TMJ osteoarthritis were randomly divided into laser and placebo groups .
METHODS	The patients in the laser group received irradiation from an 810 nm low-level laser ( Peak power 80 W , average power 50 mW , 1500 Hz , 1 micro s pulse width , 120 seconds , 6 J , 3.4 J/cm ( 2 ) per point ) , which was applied on four points around the TMJs and on painful muscles three times a week for 4 weeks .
METHODS	In the placebo group , the treatment was the same as that in the laser group , but with laser simulation .
METHODS	The patients were evaluated before laser therapy ( T1 ) , after 6 ( T2 ) and 12 ( T3 ) laser applications and 1 month after the last application ( T4 ) , and the amount of mouth opening and the pain intensity were recorded .
RESULTS	No significant differences were found in mouth opening either between the study groups or between the different evaluation times in each group ( P > 0.05 ) .
RESULTS	There was no significant difference in pain symptoms of the masticatory muscles and TMJ between the laser and the placebo groups ( P > 0.05 ) , but some significant within-group improvements were present for Visual Analogue Scale ( VAS ) scores of the body of the masseter and TMJ in both groups .
CONCLUSIONS	LLLT using the present laser parameters was no more effective than the placebo treatment for reducing pain and improving mouth opening in patients with TMJ osteoarthritis .

###25945551
BACKGROUND	Hypoxemia secondary to reduced barometric pressure is a complication of ascent to altitude .
BACKGROUND	We designed a study to compare the reversal of hypobaric hypoxemia at 14,000 ft with continuous flow oxygen from a cylinder and pulsed dose oxygen from a portable concentrator .
METHODS	There were 30 healthy volunteers who were randomized to one of three study groups , placed in an altitude chamber , and ascended to 14,000 ft. There were 10 subjects in each study group .
METHODS	Subjects breathed room air for 10 min to induce hypoxemia .
METHODS	Oxygen was then delivered via a nasal cannula from a cylinder at 1 , 2 , or 3 lpm of continuous flow for 10 min .
METHODS	The subjects again breathed room air at altitude for 10 min and were then placed on pulsed dose oxygen and titrated to obtain the continuous flow Spo2 equivalent .
METHODS	Spo2 , Etco2 , RR , HR , Hgb , and tissue oxygenation ( Sto2 ) were continuously recorded .
RESULTS	The 1-lpm group 's Spo2 range was 89-99 % .
RESULTS	The 2-lpm group 's Spo2 range was 95-98 % , and the 3-lpm group 's Spo2 range was 95-99 % .
RESULTS	The 2-lpm and 3-lpm flows were able to correct hypoxemia in every subject .
RESULTS	The mean pulsed dose required to achieve an equivalent Spo2 ranged from 36.8 ml 18.9 ml in the 1-lpm arm , and 102.4 ml 53.8 in the 3-lpm arm .
CONCLUSIONS	Portable oxygen concentrators using pulsed dose technology corrected hypoxemia in every subject .
CONCLUSIONS	Oxygen concentrators may be an alternative to liquid oxygen or cylinders for use during aeromedical evacuation .

###24952281
BACKGROUND	Breast cancer is the most common cancer and the leading cause of death among Latinas in the United States .
BACKGROUND	The Multi-level Intervention to Increase Participation in Mammography Screening study ( Fortaleza Latina ! )
BACKGROUND	is a partnership among research institutions , a Latino-serving community-based primary care clinic organization , and a cancer treatment center .
BACKGROUND	The study will assess the efficacy of a clinic - and patient-level program to increase breast cancer screening among Latinas in Western Washington .
METHODS	The intervention is a multi-level breast cancer screening program in four participating primary care clinics .
METHODS	The study is a parallel randomized controlled trial of 600 Latino women aged 42-74 who are non-compliant with breast cancer screening guidelines .
METHODS	Participants will be randomized within clinic using block randomization to : ( 1 ) a control arm ( usual care ) ; and ( 2 ) a theory-based counseling program consisting of a ` promotora ' or community health worker-led home-based intervention to encourage breast cancer screening .
METHODS	At the clinic-level , two clinics will offer additional mammography services provided by a mobile mammography unit operated by the Seattle Cancer Care Alliance .
METHODS	The primary endpoint is the rate of mammography uptake over the 1-year follow-up period .
CONCLUSIONS	This multi-level intervention aims to raise rates of participation in breast cancer screening among Latino women .
CONCLUSIONS	If effective , the program may improve rates of early detection of breast cancer in Latino women .
CONCLUSIONS	Clinicaltrials.gov
BACKGROUND	NCT02010008 .

###25467619
OBJECTIVE	To determine the perceived risk of type 2 diabetes in a sample of healthy middle-aged adults and examine the association between perceived risk and modelled risk , clinical risk factors , and psychological factors theorised to be antecedents of behaviour change .
METHODS	An exploratory , cross-sectional analysis of perceived risk of type 2 diabetes ( framed according to time and in comparison with peers ) was conducted using baseline data collected from 569 participants of the Diabetes Risk Communication Trial ( Cambridgeshire , UK ) .
METHODS	Type 2 diabetes risk factors were measured during a health assessment and the Framingham Offspring Diabetes Risk Score was used to model risk .
METHODS	Questionnaires assessed psychological factors including anxiety , diabetes-related worry , behavioural intentions , and other theory-based antecedents of behaviour change .
METHODS	Multivariable regression analyses were used to examine associations between perceived risk and potential correlates .
RESULTS	Participants with a high perceived risk were at higher risk according to the Framingham Offspring Diabetes Risk Score ( p < 0.001 ) .
RESULTS	Higher perceived risk was observed in those with a higher body fat percentage , lower self-rated health , higher diabetes-related worry , and lower self-efficacy for adhering to governmental recommendations for physical activity ( all p < 0.001 ) .
RESULTS	The framing of perceived risk according to time and in comparison with peers did not influence these results .
CONCLUSIONS	High perceived risk of type 2 diabetes is associated with higher risk of developing the disease , and a decreased likelihood of engagement in risk-reducing health behaviours .
CONCLUSIONS	Risk communication interventions should target high-risk individuals with messages about the effectiveness of prevention strategies .

###25527758
BACKGROUND	Although multivitamins are widely used , there are limited prospective studies investigating their association with both long - and short-term risk of cardiovascular disease ( CVD ) .
OBJECTIVE	The objective was to investigate how multivitamin use is associated with the long - and short-term risk of CVD .
METHODS	A prospective cohort study was conducted of 37,193 women from the Women 's Health Study aged 45 y and free of CVD and cancer at baseline who were followed for an average of 16.2 y.
METHODS	At baseline , women self-reported a wide range of lifestyle , clinical , and dietary factors .
METHODS	Women were categorized into 1 ) no current use and 2 ) current use of multivitamins .
METHODS	Duration and updated measures over the course of the follow-up to address short-term effects were also considered .
METHODS	Women were followed for major CVD events , including myocardial infarction ( MI ) , stroke , and CVD death .
RESULTS	During the follow-up , 1493 incident cases of CVD [ defined as myocardial infarction ( MI ) , stroke , and CVD death ] occurred .
RESULTS	In multivariable analyses , multivitamin use compared with no use was not associated with major CVD events ( HR : 1.01 ; 95 % CI : 0.89 , 1.15 ) , MI ( HR : 1.04 ; 95 % CI : 0.84 , 1.27 ) , stroke ( HR : 0.99 ; 95 % CI : 0.83 , 1.18 ) , or CVD death ( HR : 1.10 ; 95 % CI : 0.84 , 1.45 ) .
RESULTS	A nonsignificant inverse association was observed between baseline multivitamin use and major CVD events among women aged 70 y ( P-interaction = 0.04 ) and those consuming < 3 servings/d of fruit and vegetables ( P-interaction = 0.01 ) .
RESULTS	When updating information on multivitamin use during the course of follow-up , no associations were observed for major CVD events ( HR : 0.91 ; 95 % CI : 0.82 , 1.02 ) , MI ( HR : 0.89 ; 95 % CI : 0.74 , 1.06 ) , stroke ( HR : 0.91 ; 95 % CI : 0.78 , 1.06 ) , and CVD death ( HR : 0.91 ; 95 % CI : 0.71 , 1.16 ) .
CONCLUSIONS	In this study of middle-aged and elderly women , neither baseline nor time-varying multivitamin use was associated with the long-term risk of major CVD events , MI , stroke , cardiac revascularizations , or CVD death .
CONCLUSIONS	Additional studies are needed to clarify the role of multivitamins on CVD .

###24566612
OBJECTIVE	To compare the immediate effects of electroacupuncture and manual acupuncture on pain , mobility and muscle strength in patients with knee osteoarthritis .
METHODS	Sixty patients with knee osteoarthritis , with a pain intensity of 2 on the pain Numerical Rating Scale , were included .
METHODS	The patients were randomised into two groups : manual acupuncture and electroacupuncture .
METHODS	Pain intensity , degree of dysfunction ( Timed Up and Go ( TUG ) test ) , maximal voluntary isometric contraction and pressure pain threshold were assessed before and after a single session of manual acupuncture or electroacupuncture treatments .
RESULTS	Both groups showed a significant reduction in pain intensity ( p < 0.001 ) and time to run the TUG test after the acupuncture treatment ( p = 0.005 for the manual acupuncture group and p = 0.002 for the electroacupuncture group ) .
RESULTS	There were no differences between the groups regarding pain intensity ( p = 0.25 ) , TUG test ( p = 0.70 ) , maximum voluntary isometric contraction ( p = 0.43 ) or pressure pain threshold ( p = 0.27 ) .
CONCLUSIONS	This study found no difference between the immediate effects of a single session of manual acupuncture and electroacupuncture on pain , muscle strength and mobility in patients with knee osteoarthritis .
BACKGROUND	RBR-9TCN2X .

###24387663
BACKGROUND	The duration between first symptom and a cancer diagnosis is important because , if shortened , may lead to earlier stage diagnosis and improved cancer outcomes .
BACKGROUND	We have previously developed a tool to measure this duration in newly-diagnosed patients .
BACKGROUND	In this two-phase study , we aimed further improve our tool and to conduct a trial comparing levels of anxiety between two modes of delivery : self-completed versus researcher-administered .
METHODS	In phase 1 , ten patients completed the modified tool and participated in cognitive debrief interviews .
METHODS	In phase 2 , we undertook a Randomised Controlled Trial ( RCT ) of the revised tool ( Cancer Symptom Interval Measure ( C-SIM ) ) in three hospitals for 11 different cancers .
METHODS	Respondents were invited to provide either exact or estimated dates of first noticing symptoms and presenting them to primary care .
METHODS	The primary outcome was anxiety related to delivery mode , with completeness of recording as a secondary outcome .
METHODS	Dates from a subset of patients were compared with GP records .
RESULTS	After analysis of phase 1 interviews , the wording and format were improved .
RESULTS	In phase 2 , 201 patients were randomised ( 93 self-complete and 108 researcher-complete ) .
RESULTS	Anxiety scores were significantly lower in the researcher-completed group , with a mean rank of 83.5 ; compared with the self-completed group , with a mean rank of 104.0 ( Mann-Whitney U = 3152 , p = 0.007 ) .
RESULTS	Completeness of data was significantly better in the researcher-completed group , with no statistically significant difference in time taken to complete the tool between the two groups .
RESULTS	When comparing the dates in the patient questionnaires with those in the GP records , there was evidence in the records of a consultation on the same date or within a proscribed time window for 32/37 ( 86 % ) consultations ; for estimated dates there was evidence for 23/37 consultations ( 62 % ) .
CONCLUSIONS	We have developed and tested a tool for collecting patient-reported data relating to appraisal intervals , help-seeking intervals , and diagnostic intervals in the cancer diagnostic pathway for 11 separate cancers , and provided evidence of its acceptability , feasibility and validity .
CONCLUSIONS	This is a useful tool to use in descriptive and epidemiological studies of cancer diagnostic journeys , and causes less anxiety if administered by a researcher .

###24277055
BACKGROUND	Radiofrequency ablation of atrial fibrillation has been associated with some risk of thromboembolic events .
BACKGROUND	Previous studies showed that preventive short episodes of forearm ischemia ( remote ischemic preconditioning [ IPC ] ) reduce exercise-induced platelet reactivity .
BACKGROUND	In this study , we assessed whether remote IPC has any effect on platelet activation induced by radiofrequency ablation of atrial fibrillation .
RESULTS	We randomized 19 patients ( age , 54.711 years ; 17 male ) undergoing radiofrequency catheter ablation of paroxysmal atrial fibrillation to receive remote IPC or sham intermittent forearm ischemia ( control subjects ) before the procedure .
RESULTS	Blood venous samples were collected before and after remote IPC/sham ischemia , at the end of the ablation procedure , and 24 hours later .
RESULTS	Platelet activation and reactivity were assessed by flow cytometry by measuring monocyte-platelet aggregate formation , platelet CD41 in the monocyte-platelet aggregate gate , and platelet CD41 and CD62 in the platelet gate in the absence and presence of ADP stimulation .
RESULTS	At baseline , there were no differences between groups in platelet variables .
RESULTS	Radiofrequency ablation induced platelet activation in both groups , which persisted after 24 hours .
RESULTS	However , compared with control subjects , remote IPC patients showed a lower increase in all platelet variables , including monocyte-platelet aggregate formation ( P < 0.0001 ) , CD41 in the monocyte-platelet aggregate gate ( P = 0.002 ) , and CD41 ( P < 0.0001 ) and CD62 ( P = 0.002 ) in the platelet gate .
RESULTS	Compared with control subjects , remote IPC was also associated with a significantly lower ADP-induced increase in all platelet markers .
CONCLUSIONS	Our data show that remote IPC before radiofrequency catheter ablation for paroxysmal atrial fibrillation significantly reduces the increased platelet activation and reactivity associated with the procedure .

###24504008
OBJECTIVE	To analyse if social capital modifies the effect of educational intervention of home visitors on mobility disability .
OBJECTIVE	Earlier studies have found that educational intervention of home visitors has a positive effect of older peoples ' functional decline , but how social capital might modify this effect is still unknown .
METHODS	We used the Danish Intervention Study on Preventive Home Visits - a prospective cohort study including 2863 75-year-olds and 1171 80-year-olds in 34 Danish municipalities - to analyse the modifying effect of different aspects of social capital on the effect of educational intervention of home visitors on functional decline .
METHODS	The three measures of social capital ( bonding , bridging , and linking ) were measured at contextual level .
METHODS	Data was analysed with multivariate linear regression model using generalised estimating equations to account for repeated measurements .
RESULTS	We found that 80-year-olds living in municipalities with high bonding ( B = 0.089 , p = 0.0279 ) and high linking ( B = 0.0929 ; p = 0.0217 ) had significant better mobility disability in average at 3-year follow up if their municipality had received intervention .
CONCLUSIONS	With the unique design of the Danish Intervention Study on Preventive Home Visits and with theory-based measures of social capital that distinguish between three aspects of social capital with focus on older people , this study contributes to the literature about the role of social capital for interventions on mobility disability .

###26011955
OBJECTIVE	To investigate the effect of preoperative psychological intervention on alleviating negative emotions in patients undergoing emergent ocular trauma surgery .
METHODS	A total of 100 patients undergoing emergent ocular trauma surgery were selected using convenience sampling and randomly divided into control ( n = 49 ) and experimental ( n = 51 ) groups .
METHODS	Patients in the control group received conventional nursing and their counterparts in the observation group were treated with individualized psychological interventions including psychological support , relaxation training , and humanistic care based on conventional nursing care .
METHODS	Self-rating anxiety scale ( SAS ) , self-rating depression scale ( SDS ) , and fear visual analog scale ( FVAS ) scores were statistically compared between the two groups .
RESULTS	The scores of SAS , SDS , and FAVS were significantly lower in the experimental group than in the control group ( all P < 0.001 ) .
CONCLUSIONS	Comprehensive psychological intervention effectively eliminates negative emotions in patients undergoing emergent ocular trauma surgery and accelerates their physical and mental recovery .

###25377507
BACKGROUND	Vascular endothelial growth factor ( VEGF ) - mediated angiogenesis plays an important role in non-small cell lung cancer ( NSCLC ) .
BACKGROUND	Ramucirumab is a human immunoglobulin G1 monoclonal antibody that inhibits VEGF receptor 2 .
BACKGROUND	This phase 2 study investigated ramucirumab in combination with first-line pemetrexed and platinum chemotherapy in advanced/metastatic NSCLC .
METHODS	Eligible stage IV nonsquamous NSCLC patients with no prior chemotherapy for metastatic disease were randomized 1:1 to pemetrexed and carboplatin ( or cisplatin ) or ramucirumab ( 10 mg/kg ) plus pemetrexed and carboplatin ( or cisplatin ) once every 3 weeks .
METHODS	Treatment was given for 4 to 6 cycles , and this was followed by a maintenance phase with pemetrexed or ramucirumab and pemetrexed .
METHODS	The primary endpoint was progression-free survival ( PFS ) with a sample size of sufficient power to detect an increase from 7 to 10.4 months .
RESULTS	From October 2010 to October 2011 , 140 patients were randomized ( pemetrexed-platinum arm , 71 ; ramucirumab-pemetrexed-platinum arm , 69 ) , and most baseline characteristics were similar for the 2 treatment arms .
RESULTS	The median PFS was 5.6 months for the pemetrexed-platinum arm and 7.2 months for the ramucirumab-pemetrexed-platinum arm ( hazard ratio , 0.75 ; P = .132 ) .
RESULTS	The objective response rates were 38.0 % and 49.3 % for the pemetrexed-platinum and ramucirumab-pemetrexed-platinum arms , respectively ( P = .180 ) .
RESULTS	The disease control rate was 70.4 % for the pemetrexed-platinum arm and 85.5 % for the ramucirumab-pemetrexed-platinum arm ( P = .032 ) .
RESULTS	The grade 3 or higher adverse events occurring in 10 % or more of patients were thrombocytopenia , neutropenia , fatigue , anemia , nausea , back pain , and hypertension .
CONCLUSIONS	The primary endpoint of significant prolongation of PFS was not met ; however , ramucirumab showed evidence of clinical activity in combination with pemetrexed and platinum in nonsquamous NSCLC patients .
CONCLUSIONS	The addition of ramucirumab to pemetrexed and platinum did not result in new or unexpected safety findings .

###24609628
OBJECTIVE	To combine multiple Heidelberg Retina Tomograph ( HRT ) parameters using the Random Forests classifier to diagnose glaucoma , both in highly and physiologically myopic ( highly myopic ) eyes and emmetropic eyes .
METHODS	Subjects consisted of healthy subjects and age-matched patients with open-angle glaucoma in emmetropic ( -1.0 to +1.0 diopters [ D ] , 63 and 59 subjects , respectively ) and highly myopic eyes ( -10.0 to -5.0 D , 56 and 64 subjects , respectively ) .
METHODS	First , area under the receiver operating characteristic curve ( AUC ) was derived using 84 HRT global and sectorial parameters and the representative HRT raw parameter ( largest AUC ) was identified .
METHODS	Then , the Random Forests method was carried out using age , refractive error , and 84 HRT parameters .
METHODS	The AUCs were also derived using the following : ( 1 ) Frederick S. Mikelberg discriminant function ( FSM ) score , ( 2 ) Reinhard O.W. Burk discriminant function ( RB ) score , ( 3 ) Moorfields regression analysis ( MRA ) score , and ( 4 ) glaucoma probability score ( GPS ) .
RESULTS	In combined emmetropic and highly myopic population , AUC with Random Forests method ( 0.96 ) was significantly larger than AUCs with the representative HRT raw parameter ( vertical cup-to-disc ratio [ global ] , 0.89 ) , FSM ( 0.90 ) , RB ( 0.83 ) , MRA ( 0.87 ) , and GPS ( 0.81 ) ( P < 0.001 ) .
RESULTS	Similarly , AUC with the Random Forests method was significantly ( P < 0.05 ) larger than these other parameters , both in emmetropic and highly myopic groups .
RESULTS	Also , the Random Forests method achieved partial AUCs above 80 % / 90 % significantly ( P < 0.05 ) larger than any other HRT parameters in all populations .
CONCLUSIONS	Evaluating multiple HRT parameters using the Random Forests classifier provided accurate diagnosis of glaucoma , both in emmetropic and highly myopic eyes .

###25087476
BACKGROUND	Dengue virus is the most serious mosquito-borne viral threat to public health and no vaccines or antiviral therapies are approved for dengue fever .
BACKGROUND	The tetravalent DENVax vaccine contains a molecularly characterised live attenuated dengue serotype-2 virus ( DENVax-2 ) and three recombinant vaccine viruses expressing the prM and E structural genes for serotypes 1 , 3 , and 4 in the DENVax-2 genetic backbone .
BACKGROUND	We aimed to assess the safety and immunogenicity of tetravalent DENVax formulations .
METHODS	We undertook a randomised , double-blind , phase 1 , dose-escalation trial between Oct 11 , 2011 , and Nov 9 , 2011 , in the Rionegro , Antioquia , Colombia .
METHODS	The first cohort of participants ( aged 18-45 years ) were randomly assigned centrally , via block randomisation , to receive a low-dose formulation of DENvax , or placebo , by either subcutaneous or intradermal administration .
METHODS	After a safety assessment , participants were randomly assigned to receive a high-dose DENVax formulation , or placebo , by subcutaneous or intradermal administration .
METHODS	Group assignment was not masked from study pharmacists , but allocation was concealed from participants , nurses , and investigators .
METHODS	Primary endpoints were frequency and severity of injection-site and systemic reactions within 28 days of each vaccination .
METHODS	Secondary endpoints were the immunogenicity of DENVax against all four dengue virus serotypes , and the viraemia due to each of the four vaccine components after immunisation .
METHODS	Analysis was by intention to treat for safety and per protocol for immunogenicity .
METHODS	Because of the small sample size , no detailed comparison of adverse event rates were warranted .
METHODS	The trial is registered with ClinicalTrials.gov , number NCT01224639 .
RESULTS	We randomly assigned 96 patients to one of the four study groups : 40 participants ( 42 % ) received low-dose vaccine and eight participants ( 8 % ) received placebo in the low-dose groups ; 39 participants ( 41 % ) received high-dose vaccine , with nine ( 9 % ) participants assigned to receive placebo .
RESULTS	Both formulations were well tolerated with mostly mild and transient local or systemic reactions .
RESULTS	No clinically meaningful differences were recorded in the overall incidence of local and systemic adverse events between patients in the vaccine and placebo groups ; 68 ( 86 % ) of 79 participants in the vaccine groups had solicited systemic adverse events compared with 13 ( 76 % ) of 17 of those in the placebo groups .
RESULTS	By contrast , 67 participants ( 85 % ) in the vaccine group had local solicited reactions compared with five ( 29 % ) participants in the placebo group .
RESULTS	Immunisation with either high-dose or low-dose DENVax formulations induced neutralising antibody responses to all four dengue virus serotypes ; 30 days after the second dose , 47 ( 62 % ) of 76 participants given vaccine seroconverted to all four serotypes and 73 ( 96 % ) participants seroconverted to three or more dengue viruses .
RESULTS	Infectious DENVax viruses were detected in only ten ( 25 % ) of 40 participants in the low-dose group and 13 ( 33 % ) of 39 participants in the high-dose group .
CONCLUSIONS	Our findings emphasise the acceptable tolerability and immunogenicity of the tetravalent DENVax formulations in healthy , flavivirus-naive adults .
CONCLUSIONS	Further clinical testing of DENVax in different age groups and in dengue-endemic areas is warranted .
BACKGROUND	Takeda Vaccines .

###25404102
OBJECTIVE	To study the role of mometasone furoate aqueous nasal spray for the management of adenoidal hypertrophy in children with more than 50 per cent obstruction , and to assess its impact on change in quality of life .
METHODS	A prospective , randomised , double-blind , interventional placebo-controlled study was conducted .
METHODS	A total of 100 children aged 2-12 years completed treatment and follow up .
METHODS	The symptoms and degree of obstruction were evaluated by nasopharyngoscopy conducted pre-treatment and 24 weeks post-treatment .
METHODS	Subjects received mometasone furoate nasal spray at a daily dose of 200g for 8 weeks , followed by a dose of 200g on alternate days for 16 weeks .
METHODS	RESULTS were compared with those of a matched control group who were given saline nasal spray .
RESULTS	With mometasone treatment , there was an 89.8 per cent reduction in clinical symptom score , and the degree of obstruction dropped from 87 to 72 per cent ( p < 0.0001 ) .
RESULTS	A statistically significant change in quality of life scores was seen in patients treated with the mometasone nasal spray ( score change of 37.47 ) as compared with those given saline nasal spray ( score change of 11.25 ) ( p = 0.0001 ) .
CONCLUSIONS	Mometasone nasal spray appears to be effective in treating children with obstructive adenoids .

###24812899
OBJECTIVE	To observe the effect of Ningdong Granule ( NG ) on serum levels of interleukin-12 ( IL-12 ) and tumor necrosis factor-alpha ( TNF-alpha ) of children patients with Tourette 's syndrome ( TS ) .
METHODS	Totally 90 TS children patients were randomly assigned to the NG group , the NG + Tiapride group ( abbreviated as the combined treatment group ) , and the Tiapride group , 30 in each group .
METHODS	Besides , another 30 healthy children were recruited as the healthy control group .
METHODS	Patients in the NG group were treated with NG ( consisting of all gastrodia rhizome , Codonopsis pilosula , Ophiopogon japonicus , white peony root , Rhinocerotidae , oyster , earthworm , licorice root , etc. ) , one dose daily , administered by dissolving it in boiled water , taken in two portions in the morning and in the evening respectively .
METHODS	Patients in the Tiapride group took Tiapride Tablet , 50 -100 mg each time , twice daily .
METHODS	The dosage was adjusted according to individual difference and changes of pathogenic conditions .
METHODS	The maximal dosage was 300 mg per day .
METHODS	Those in the combined treatment group were treated with equal dose of NG and Tiapride Tablet in combination .
METHODS	The treatment course was 3 months for all .
METHODS	Changes of pathogenic condition before and after treatment were assessed by Yale global tic severity scale ( YGTSS ) .
METHODS	Serum levels of IL-12 and TNF-alpha were detected by enzyme-labeled immunosorbent assay ( ELISA ) before and after treatment .
RESULTS	( 1 ) The total effective rate of the NG group , the combined treatment group , and the Tiapride group was 79.3 % , 83.3 % , and 67.9 % , respectively .
RESULTS	It was the lowest in the Tiapride group ( P < 0.05 ) .
RESULTS	It was significantly higher in the combined treatment group than in the NG group ( P < 0.05 ) .
RESULTS	( 2 ) The post-treatment YGTSS score was obviously lower in each group after treatment than before treatment ( P < 0.05 ) .
RESULTS	The posttreatment YGTSS score was obviously lower in the NG group and the combined treatment group than in the Tiapride group ( P < 0.05 ) , but with no statistical difference between the fromer two groups ( P > 0.05 ) .
RESULTS	( 3 ) Compared with the healthy control group before treatment , serum levels of IL-12 and TNF-alpha ( pg/mL ) were 124.95 + / - 22.78 and 209.52 + / - 21.69 in the NG group , 126.14 + / - 25.65 and 208.97 + / - 22.46 in the combined treatment group , 123.00 + / - 24.26 and 205.10 + / - 26.16 in the Tiapride group , being higher than those in the healthy control group ( 64.56 + / - 27.59 and 78.13 + / - 33.42 ; P < 0.05 ) .
RESULTS	After treatment , serum levels of of IL-12 and TNF-alpha were 104.67 + / - 16.84 and 183.01 + / - 24.95 in the NG group , 109.04 + / - 16.81 and 179.87 + / - 23.45 in the combined treatment group , significantly lower than before treatment ( P < 0.05 ) .
RESULTS	But there was no statistical difference in serum levels of IL-12 or TNF-alpha in the Tiapride group between before treatment ( 123.00 + / - 24.26 and 205.10 + / - 26.16 ) and after treatment ( 117.75 + / - 16.79 and 199.76 + / - 33.21 ; P > 0.05 ) .
CONCLUSIONS	NG could modulate abnormal serum levels of IL-12 and TNF-alpha in TS children patients , which might be one of its pharmacodynamic mechanisms for treating TS .

###24942382
OBJECTIVE	To evaluate the effect of certolizumab pegol ( CZP ) on productivity outside and within the home , and on participation in family , social and leisure activities in adult patients with psoriatic arthritis ( PsA ) .
METHODS	RAPID-PsA ( NCT01087788 ) is a phase 3 , double-blind , placebo-controlled trial .
METHODS	409 patients with active PsA were randomised 1:1:1 to placebo , CZP 200mg every 2weeks ( Q2W ) or CZP 400mg every 4weeks ( Q4W ) .
METHODS	The arthritis-specific Work Productivity Survey ( WPS ) assessed the impact of PsA on paid work and household productivity , and participation in social activities during the preceding month .
METHODS	WPS responses were compared between treatment arms using a non-parametric bootstrap-t method .
RESULTS	At baseline , 56.6 % , 60.1 % and 61.5 % of placebo , CZP 200mg Q2W and CZP 400mg Q4W patients were employed .
RESULTS	By week 24 , employed CZP patients reported an average of 1.0-1 .8 and 3.0-3 .9 fewer days of absenteeism and presenteeism , respectively , per month compared with 1.0 and 0.3 fewer days for placebo patients ( p < 0.05 ) .
RESULTS	Within the home , by week 24 , CZP patients reported an average of 3.0-3 .5 household work days gained per month versus 1.0 day for placebo ( p < 0.05 ) .
RESULTS	CZP patients also reported fewer days with reduced household productivity or days lost for participation in family , social and leisure activities .
RESULTS	Improvements with CZP were seen as early as week 4 and continued to week 24 .
CONCLUSIONS	CZP treatment significantly improved productivity at paid work and within the home , and resulted in greater participation in social activities for PsA patients .
BACKGROUND	NCT01087788 .

###24628035
OBJECTIVE	Two double-blind , randomized studies were conducted to assess the tolerability , pharmacokinetics and pharmacodynamics of oral TA-8995 , a new cholesteryl ester transfer protein ( CETP ) inhibitor , in healthy subjects .
METHODS	Study 1 : Subjects received single doses of TA-8995 or placebo ( fasted ) .
METHODS	Doses were 5 , 10 , 25 , 50 ( fed/fasted ) , 100 and 150mg ( Caucasian males , 18-55years ) , 25mg ( Caucasian males , > 65years and Caucasian females , 18-55years ) , 25 , 50 , 100 and 150mg ( Japanese males , 18-55years ) .
METHODS	Study 2 : Caucasian males ( 18-55years ) received 1 , 2.5 , 10 or 25mg once daily TA-8995 or placebo for 21-28days .
METHODS	Blood and urine for pharmacokinetics and/or pharmacodynamics were collected .
METHODS	Tolerability was assessed by adverse events , vital signs , electrocardiograms and laboratory safety tests .
RESULTS	Peak TA-8995 concentrations occurred approximately 4h post-dose .
RESULTS	Mean half-lives ranged from 81 to 166h , without an obvious dose relationship .
RESULTS	Exposure increased less than proportionally to dose .
RESULTS	TA-8995 was not excreted in urine .
RESULTS	Following 2.5 to 25mg once daily dosing , TA-8995 demonstrated nearly complete inhibition of CETP activity ( 92-99 % ) , increased high density lipoprotein-cholesterol ( HDL-C ) by 96 to 140 % and decreased low density liporotein-cholesterol ( LDL-C ) by 40 % to 53 % .
RESULTS	There were dose-related increases in apolipoproteins A-1 and E , HDL2-C and HDL3-C , and decreases in apolipoprotein B and lipoprotein A.
RESULTS	There was no evidence of significant effects of age , gender , ethnicity or food on pharmacokinetics or pharmacodynamics .
RESULTS	All doses were well tolerated .
CONCLUSIONS	TA-8995 is a potent CETP inhibitor and warrants further investigation .

###25069531
BACKGROUND	Limited data exist regarding the efficacy of metoclopramide in the treatment of intractable hiccups .
OBJECTIVE	This study aimed to assess the feasibility efficacy of metoclopramide in the treatment of patients with intractable hiccups .
METHODS	A total of 36 patients with intractable hiccups was randomly assigned to arm A ( n = 18 ) or arm B ( n = 18 ) in a multicentre , double-blind , randomised , controlled pilot study .
METHODS	Participants in arm A received 10-mg metoclopramide thrice daily for 15 days , whereas those assigned to arm B received 10-mg placebo thrice daily for 15 days .
METHODS	The primary outcome measure was total efficacy against hiccups ( including cessation and improvement of hiccups ) .
METHODS	Secondary outcome measures included a comparison of overall efficacy and adverse events between the two arms .
RESULTS	Of the 36 patients enrolled , 34 participants completed the study .
RESULTS	The total efficacy was higher in arm A than in arm B ( relative risk , 2.75 ; 95 % confidence interval : 1.09-6 .94 , P = 0.03 ) .
RESULTS	Furthermore , comparison between the two arms revealed that overall efficacy was higher in arm A than that in arm B ( P < 0.05 ) .
RESULTS	No serious adverse events related to the treatment were documented in either arm .
RESULTS	The most common adverse events occurring in patients in arm A included fatigue , upset mood and dizziness .
CONCLUSIONS	Metoclopramide appears to be a promising candidate for the treatment of patients with intractable hiccups , with mild adverse events .
CONCLUSIONS	However , further clinical trials are required to confirm these results .

###25880278
BACKGROUND	Plain packaging requires tobacco products to be sold in packs with a standard shape , method of opening and colour , leaving the brand name in a standard font and location .
BACKGROUND	We ran a randomised controlled trial to investigate the impact of plain packaging on smoking behaviour and attitudes .
METHODS	In a parallel group randomised trial design , 128 daily smokers smoked cigarettes from their usual UK brand , or a plain Australian brand that was closely matched to their usual UK brand for 24 hours .
METHODS	Primary outcomes were number of cigarettes smoked and volume of smoke inhaled per cigarette .
METHODS	Secondary outcomes were self-reported ratings of motivation to quit , cigarette taste , experience of using the pack , experience of smoking , attributes of the pack , perceptions of the health warning , changes in smoking behaviour , and views on plain packaging .
RESULTS	There was no evidence that pack type had an effect on either of the primary measures ( ps > 0.279 ) .
RESULTS	However , smokers using plain cigarette packs rated the experience of using the pack more negatively ( -0.52 , 95 % CI -0.82 to -0.22 , p = 0.001 ) , rated the pack attributes more negatively ( -1.59 , 95 % CI -1.80 to -1.39 , p < 0.001 ) , and rated the health warning as more impactful ( +0.51 , 95 % CI 0.24 to 0.78 , p < 0.001 ) .
CONCLUSIONS	Plain cigarette packs reduce ratings of the experience of using the cigarette pack , and ratings of the pack attributes , and increase the self-perceived impact of the health warning , but do not change smoking behaviour , at least in the short term .
BACKGROUND	Current Controlled Trials ISRCTN52982308 .
BACKGROUND	Registered 27 June 2013 .

###24628438
BACKGROUND	Until now , working memory training has not reached sufficient evidence as effective treatment for ADHD core symptoms in children with ADHD ; for young children with ADHD , no studies are available .
BACKGROUND	To this end , a triple-blind , randomized , placebo-controlled study was designed to assess the efficacy of Cogmed Working Memory Training ( CWMT ) in young children with ADHD .
METHODS	Fifty-one children ( 5-7years ) with a DSM-IV-TR diagnosis of ADHD ( without current psychotropic medication ) were randomly assigned to the active ( adaptive ) or placebo ( nonadaptive ) training condition for 25 sessions during 5 weeks .
METHODS	The compliance criterion ( > 20 sessions ) was met for 47 children .
METHODS	The primary outcome measure concerned the core behavioural symptoms of ADHD , measured with the ADHD Rating Scale IV ( ADHD-RS ) .
METHODS	Secondary outcome measures were neurocognitive functioning , daily executive functioning , and global clinical functioning .
METHODS	The influence of the increase in difficulty level ( Index-Improvement ) for the treatment group was also analysed .
METHODS	Clinical trial registration information - ` Working Memory Training in Young ADHD Children ' ; www.clinicaltrials.gov ; NCT00819611 .
RESULTS	A significant improvement in favour of the active condition was found on a verbal working memory task ( p = .041 ; adapted Digit Span WISC-III , backward condition ) .
RESULTS	However , it did not survive correction for multiple testing .
RESULTS	No significant treatment effect on any of the primary or other secondary outcome measurements was found .
RESULTS	The Index-Improvement significantly contributed to ADHD-RS and the Behavior Rating Inventory of Executive Function , both rated by the teacher , but revealed no significant group difference .
CONCLUSIONS	This study failed to find robust evidence for benefits of CMWT over the placebo training on behavioural symptoms , neurocognitive , daily executive , and global clinical functioning in young children with ADHD .

###24812104
BACKGROUND	In our previous randomised controlled trial ( RCT ) , we have shown in preterm babies ( PBs ) < 30weeks gestation that CeasIng Cpap At standarD criteriA ( CICADA ( method 1 ) ) compared with cycling off continuous positive airway pressure ( CPAP ) gradually ( method 2 ) or cycling off CPAP gradually with low flow air/oxygen during periods off CPAP ( method 3 ) reduces CPAP cessation time in PBs < 30weeks gestation .
METHODS	This retrospective study reviewed weight gain , time to reach full feeds and time to cease caffeine in PBs previously enrolled in the RCT .
RESULTS	Data were collected from 162 of the 177 PBs , and there was no significant difference in the projected weight gain between the three methods .
RESULTS	Based on intention to treat , the time taken to reach full feeds for all three methods showed no significant difference .
RESULTS	However , post hoc analysis showed the CICADA method compared with cycling off gradually just failed significance ( 30.31.6 vs 31.12.4 ( weeks corrected gestational age ( Wks CGASD ) ) , p = 0.077 ) .
RESULTS	Analysis of time to cease caffeine showed there was a significant difference between the methods with PBs randomised to the CICADA method compared with the cycling off method ceasing caffeine almost a week earlier ( 33.62.4 vs 34.52.8 ( Wks CGASD ) , p = 0.02 ) .
CONCLUSIONS	This retrospective study provides evidence to substantiate the optimum method of ceasing CPAP ; the CICADA method , does not adversely affect weight gain , time to reach full feeds and may reduce time to cease caffeine in PBs < 30weeks gestation .

###25449504
BACKGROUND	The effect of intracoronary adenosine ( ADO ) on ST-segment elevation myocardial infarction ( STEMI ) size and adverse remodeling is not well established .
METHODS	In a double-blind trial , 201 patients with STEMI were randomized to receive percutaneous coronary intervention ( PCI ) within 6 hours of symptom onset , 4.5 mg ADO or saline immediately prior to reperfusion .
METHODS	Primary end-point : percentage of total myocardial necrotic mass by cardiac magnetic resonance ( CMR ) 2-7 days post-reperfusion .
METHODS	Secondary end-points : changes in left ventricular volumes and ejection fraction ( LVEF ) at baseline and at 6 months .
RESULTS	Baseline CMR could not be performed in 20 patients .
RESULTS	Overall , no significant differences were observed between ADO and placebo regarding infarct size ( 20.8 % vs. 22.5 % ; p = 0.40 ) .
RESULTS	However , infarct size was significantly reduced ( 19.4 % vs. 25.7 % ; p for interaction = 0.031 ) in those with ischemia duration below the median ( 200 min ) .
RESULTS	CMR at 6 months , performed in 138 patients , did not show statistically significant differences between groups in the rate of LVEF increase ( 3.3 units ( SD 9.6 ) in ADO group vs. 1.5 units ( SD 9 ) in placebo group ; p = 0.25 ) .
RESULTS	In the subgroup analysis , among patients with ischemia time below 200 min , the increase in LVEF was slightly higher with ADO ( 3.59 % vs. 0.43 % ; p for interaction = 0.06 ) .
CONCLUSIONS	Although our study failed to demonstrate that intracoronary administration of ADO prior to PCI limits infarct size , in patients receiving early PCI ADO might enhance myocardial salvage and has a favorable effect on LVEF evolution , which may help to reconcile apparently contradictory results of previous studies .
BACKGROUND	http://clinicaltrials.gov ( NCT00781404 ) .

###25188501
OBJECTIVE	To evaluate aripiprazole once-monthly ( AOM ) , a long-acting injectable suspension of aripiprazole , as acute treatment in patients with schizophrenia ( DSM-IV-TR ) .
METHODS	Adults experiencing an acute psychotic episode were randomized to 12 weeks of double-blind treatment with AOM 400 mg or placebo ( October 2012-August 2013 ) .
METHODS	The primary efficacy outcome was change from baseline to endpoint ( week 10 ) in Positive and Negative Syndrome Scale ( PANSS ) total score .
METHODS	The key secondary efficacy outcome was change from baseline in Clinical Global Impressions-Severity of Illness scale ( CGI-S ) score .
METHODS	Secondary efficacy outcomes included change from baseline in PANSS positive and negative subscale and Personal and Social Performance Scale ( PSP ) scores .
METHODS	The study took place from October 2012 through August 2013 .
RESULTS	Patients ( N = 340 ; 79 % male , 66 % black ) were randomized to AOM ( n = 168 ) or placebo ( n = 172 ) .
RESULTS	Least squares ( LS ) mean change from baseline to endpoint ( week 10 ) favored AOM versus placebo in PANSS total ( treatment difference , -15.1 [ 95 % CI , -19.4 to -10.8 ] ; P < .0001 ) and CGI-S ( treatment difference , -0.8 [ 95 % CI , -1.1 to -0.6 ] ; P < .0001 ) scores , as it did at all other timepoints through 12 weeks ( all P .0005 ) .
RESULTS	LS mean change from baseline in PANSS positive and negative subscale and PSP scores favored AOM versus placebo ( P < .0001 ) .
RESULTS	Common ( > 10 % ) treatment-emergent adverse events ( AOM vs. placebo ) were increased weight ( 16.8 % vs 7.0 % ) , headache ( 14.4 % vs. 16.3 % ) , and akathisia ( 11.4 % vs 3.5 % ) .
CONCLUSIONS	Symptoms and functioning improved with AOM 400 mg versus placebo in patients with acute schizophrenia , with acceptable safety and tolerability .
CONCLUSIONS	These data suggest that AOM 400 mg is a viable treatment option for patients experiencing an acute schizophrenia episode .
BACKGROUND	ClinicalTrials.gov identifier : NCT01663532 .

###25706053
OBJECTIVE	This study investigated the short-term effects of Kinesio taping ( KT ) on various types of pain , active range of motion ( AROM ) , and proprioception in patients with knee osteoarthritis .
METHODS	Forty-six older participants ( mean [ SD ] , 57.9 [ 4.4 ] yrs ) with osteoarthritis were randomly allocated to two groups : the KT group or the placebo-KT group .
METHODS	Taping with tension ( KT application ) or without tension ( placebo-KT application ) was applied to the quadriceps of the participants in both groups .
METHODS	Before and after intervention , pain intensity was measured using a visual analog scale at rest and during walking , and pressure pain thresholds ( PPTs ) were assessed using an algometer in the quadriceps and the tibialis anterior .
METHODS	In addition , pain-free AROM and proprioception were measured .
RESULTS	The KT group showed attenuation of pain during walking ( effect size [ ES ] , 1.97 ) , PPT in the quadriceps ( ES , 2.58 ) , and PPT in the tibialis anterior ( ES , 2.45 ) .
RESULTS	This group also showed significantly improved AROM ( ES , 2.01 ) and proprioception ( ES , 1.73-1 .89 ; P < 0.05 ) .
RESULTS	However , the placebo-KT group did not show significant changes in pain , AROM , or proprioception .
RESULTS	There were significant differences between the two groups in pain during walking and PPT .
RESULTS	In addition , pain during walking showed a significant correlation with AROM and proprioception , and a significant correlation was found between PPT and AROM .
CONCLUSIONS	These results demonstrated that KT application with proper tension to the quadriceps effectively attenuates various types of pain and improves AROM and proprioception in osteoarthritis patients .
CONCLUSIONS	Thus , KT may be a suitable intervention to improve pain , AROM , and proprioception in patients with osteoarthritis in clinics .

###24804879
OBJECTIVE	The literature on the relationship of depressive symptoms and stress hormones after cancer diagnosis has been mixed , with some studies showing a relationship and other studies showing none .
OBJECTIVE	Time since diagnosis may explain these contradictory findings .
OBJECTIVE	This study examined the relationship of depressive symptoms to stress hormones in patients with breast cancer using 12-month longitudinal data .
METHODS	Patients with Stage II or III breast cancer ( n = 227 ) were assessed every 4 months from diagnosis/surgery to 12 months .
METHODS	They completed the Centers for Epidemiological Studies Depression Scale ( CES-D ) Iowa Short Form and the Perceived Stress Scale and blood samples were obtained to measure stress hormones ( i.e. , cortisol , adrenocorticotropin hormone , norepinephrine , and epinephrine ) .
RESULTS	Depressive symptoms were negatively related to cortisol levels ( = -0.023 , p = .002 ) but were positively related to rate of change in cortisol ( = 0.003 , p = .003 ) .
RESULTS	Adrenocorticotropin hormone , epinephrine , and norepinephrine did not covary with depressive symptoms ( all p values > .05 ) .
RESULTS	When the CES-D and Perceived Stress Scale were both used to predict cortisol , only the CES-D was significantly related ( = -0.025 , p = .017 ) .
CONCLUSIONS	Depressive symptoms were negatively related to cortisol , but this relationship changed from the time of diagnosis/surgery through 12 months .
CONCLUSIONS	Cortisol may initially provide a buffering effect against depression during the stress of initial diagnosis and treatment , but this relationship seems to change over time .

###25464505
BACKGROUND	Hematologic reference values vary by ethnicity .
BACKGROUND	We aimed to determine reference values of hemoglobin ( Hb ) for Korean adolescents .
METHODS	Using data from the 5th Korean National Health and Nutrition Examination Survey ( KNHANES ) , we obtained reference values for Hb in adolescents aged 10-20 years .
RESULTS	Among 2,526 subjects recruited , 330 were excluded due to chronic diseases ( 9 congenital heart disease , 6 epilepsy , and 1 thyroid disease ) or abnormal laboratory values ( 253 subjects with Fe/TIBC < 16 % , 103 subjects with MCV < 80fl ) .
RESULTS	Accordingly , data from 2,196 subjects ( male = 1,196 and female = 1,000 ) were analyzed and age - and gender-stratified means and percentile values of Hb were obtained .
RESULTS	Pertinent findings observed in the current study were : ( i ) Hb levels in Korean male were similar to those of non-Hispanic Caucasians ; ( ii ) Hb values in females were similar to those of non-Hispanic Caucasians until age of 15 , and thereafter were slightly lower .
RESULTS	Prevalence of anemia according to WHO criteria and our own criteria ( Hb levels < 2 standard deviations of age - and gender-specific values ) in total sample was 3.5 % ( 88/2 ,526 ) and 3.8 % ( 97/2 ,526 ) , respectively .
RESULTS	Anemia was more prevalent in female in comparison with male ( 6.5 % vs. 1.0 % , P < 0.001 ) .
CONCLUSIONS	Our results could be used as a national reference standard to correctly classify a large population sample .
CONCLUSIONS	Further studies are necessary to determine reference Hb values for children younger than 10 years and identify genetic variations associated with distinctive characteristics observed in this study .

###24814566
BACKGROUND	Most tobacco smokers who wish to quit fail to reach their goal .
BACKGROUND	One important , insufficiently emphasized aspect of addiction relates to the decision-making system , often characterized by dysfunctional cognitive control and a powerful drive for reward .
BACKGROUND	Recent proof-of-principle studies indicate that transcranial direct current stimulation ( tDCS ) over the dorsolateral prefrontal cortex ( DLPFC ) can transiently modulate processes involved in decision-making , and reduce substance intake and craving for various addictions .
BACKGROUND	We previously proposed that this beneficial effect of stimulation for reducing addictive behaviors is in part mediated by more reflective decision-making .
BACKGROUND	The goal of this study was to test whether nicotine intake and decision-making behaviors are modulated by tDCS over the DLPFC in tobacco smokers who wished to quit smoking .
METHODS	Subjects received two five-day tDCS regimens ( active or sham ) .
METHODS	Stimulation was delivered over the right DLPFC at a 2 mA during 30 min .
METHODS	Nicotine cravings , cigarette consumption and decision-making were assessed before and after each session .
RESULTS	Main findings include a significant decrease in the number of cigarettes smoked when participants received active as compared to sham stimulation .
RESULTS	This effect lasted up to four days after the end of the stimulation regimen .
RESULTS	In regards to decision-making , smokers rejected more often offers of cigarettes , but not offers of money , after they received active as compared to sham stimulation at the Ultimatum Game .
RESULTS	No significant change was observed at the Risk Task with cigarettes or money as rewards .
CONCLUSIONS	Overall , these findings suggest that tDCS over the DLPFC may be beneficial for smoking reduction and induce reward sensitive effects .

###25293728
BACKGROUND	Previous studies showed that noncoplanar intensity-modulated radiotherapy ( NC-IMRT ) for sinonasal cancer is superior to coplanar intensity-modulated radiotherapy ( IMRT ) .
BACKGROUND	Volumetric-modulated arc therapy ( VMAT ) is a newly introduced treatment modality , and the performance of noncoplanar VMAT for sinonasal cancer has not been well described to date .
OBJECTIVE	To compare the dosimetry difference of noncoplanar VMAT ( NC-VMAT ) , coplanar VMAT ( co-VMAT ) , and NC-IMRT for sinonasal cancer .
METHODS	Ten postoperative patients with sinonasal cancer were randomly selected for planning with NC-VMAT , co-VMAT , and NC-IMRT .
METHODS	Two planning target volumes ( PTVs ) were contoured representing high-risk and low-risk regions set to receive a median absorbed dose ( D50 % ) of 68 Gy and 59 Gy , respectively .
METHODS	The homogeneity index ( HI ) , conformity index ( CI ) , dose-volume histograms ( DVHs ) , and delivery efficiency were all evaluated .
RESULTS	Both NC-VMAT and co-VMAT showed superior dose homogeneity and conformity in PTVs compared with NC-IMRT .
RESULTS	There was no significant difference between NC-VMAT and co-VMAT in PTV coverage .
RESULTS	Both VMAT plans provided a better protection for organs at risk ( OARs ) than NC-IMRT plans , and NC-VMAT showed a small improvement over co-VMAT in sparing of OARs .
RESULTS	For peripheral doses , the doses to breast , thyroid , and larynx in the NC-IMRT plans were significantly higher than those in both VMAT plans .
RESULTS	Compared to NC-VMAT , co-VMAT significantly reduced peripheral doses .
RESULTS	NC-VMAT and co-VMAT reduced the average delivery time by 63.2 and 64.2 % , respectively , in comparison with NC-IMRT .
RESULTS	No differences in delivery efficiency were observed between the two VMAT plans .
CONCLUSIONS	Compared to NC-VMAT , co-VMAT showed similar PTV coverage and comparable OAR sparing but significantly reduced peripheral doses and positioning uncertainty .
CONCLUSIONS	We propose to give priority to coplanar VMAT in the treatment of sinonasal cancer .

###26102252
OBJECTIVE	There are no current pharmacological therapies for the prevention or treatment of acute respiratory distress syndrome .
OBJECTIVE	Early dysregulated inflammation likely plays a role in acute respiratory distress syndrome development and possibly acute respiratory distress syndrome outcomes .
OBJECTIVE	p38 mitogen-activated protein kinase is central to the regulation of multiple inflammatory mediators implicated in acute organ dysfunction and is the target for a novel class of cytokine-suppressive anti-inflammatory drugs .
OBJECTIVE	In preclinical models , p38 inhibitors reduce lung injury following pancreatitis and burn injury .
METHODS	We conducted a phase IIa , randomized , double-blind , placebo-controlled , parallel-group study to evaluate the safety and tolerability of dilmapimod , a novel p38 mitogen-activated protein kinase inhibitor , in patients at risk for developing acute respiratory distress syndrome admitted with an Injury Severity Score more than 16 , excluding head trauma .
METHODS	Enrolled patients received 4 - or 24-hour IV dilmapimod infusions at different doses or placebo , daily for 3 days , in four separate cohorts .
METHODS	Multicenter randomized clinical trial of large , academic trauma centers .
RESULTS	Seventy-seven patients were enrolled .
RESULTS	Although adverse events were common in this critically ill population , dilmapimod was well tolerated , with no clinically relevant safety findings .
RESULTS	Pharmacokinetic models indicated that the higher dose of 10mg given as continuous infusion over 24 hours had the most favorable plasma concentration profile .
RESULTS	Likewise , measures of soluble inflammatory markers including interleukin-6 , C-reactive peptide , interleukin-8 , and soluble tumor necrosis factor receptor 1 were most different between this dosing arm and placebo .
RESULTS	Although the study was not specifically designed with acute respiratory distress syndrome as an outcome , the number of patients who developed acute respiratory distress syndrome was small ( 2/77 ) .
CONCLUSIONS	The novel p38 mitogen-activated protein kinase inhibitor dilmapimod appears well tolerated and may merit further evaluation for prevention of acute respiratory distress syndrome and other organ injury in larger clinical trials .
CONCLUSIONS	Furthermore , results of this early-phase trial may aid in design of future studies aimed at prevention of acute respiratory distress syndrome and other organ injury .

###24917588
OBJECTIVE	To compare the effectiveness of two procedures increasing the botulinum toxin type A effect for wrist and finger flexor spasticity after stroke .
METHODS	A single-blind randomized trial .
METHODS	Seventy patients with upper limb post-stroke spasticity .
METHODS	Adults with wrist and finger flexor muscles spasticity after stroke were submitted to botulinum toxin type A therapy .
METHODS	After the treatment , the subjects injected were randomly divided into two groups and submitted to adhesive taping ( Group A ) or daily muscle manual stretching , passive articular mobilization of wrist and fingers , and palmar splint ( Group B ) for 10 days .
METHODS	We measured spasticity with Modified Ashworth Scale , related disability with Disability Assessment Scale , and fingers position at rest .
METHODS	The measurements were done at baseline , after two weeks , and after one month from the treatment session .
RESULTS	After two weeks , subjects in Group A reported a significantly greater decrease in spasticity scores ( Modified Ashworth Scale fingers : mean ( standard deviation ) 1.30.6 vs. 2.10.6 ; Modified Ashworth Scale wrist : 1.7 0.6 vs. 2.3 0.8 ) , and after one month in spasticity and disability scores ( Modified Ashworth Scale fingers : mean ( standard deviation ) 1.9 0.7 vs. 2.5 0.6 ; Modified Ashworth Scale wrist : 2.0 0.7 vs. 2.6 0.6 ; Disability Assessment Scale : 1.6 0.7 vs. 2.1 0.7 ) compared with Group B subjects .
RESULTS	Subjects in Group A reported also a significantly improved fingers position at rest compared with Group B subjects after two weeks ( 2.8 0.9 vs. 2.1 0.7 ) and one month ( 2.3 0.7 vs. 1.5 0.6 ) .
CONCLUSIONS	Adhesive taping of wrist and finger flexor muscles appeared to enhance the effect of botulinum toxin type A therapy more than daily manual muscle stretching combined with passive articular mobilization and palmar splint .

###24645833
BACKGROUND	Research has shown that 6h after breeding is a critical time during the uterine innate immune response , and the failure to respond appropriately will result in persistent breeding-induced endometritis .
BACKGROUND	This presents a potential opportunity to modulate the course of inflammation towards a timely resolution .
OBJECTIVE	To evaluate the effects of immune modulation on endometrial mRNA expression of inflammatory genes in susceptible mares 6h after breeding .
OBJECTIVE	The hypothesis was that immune modulation alters endometrial cytokine expression in susceptible mares .
METHODS	A randomised controlled study to evaluate the effects of mycobacterial cell wall extract and dexamethasone on endometrial gene expression after insemination in 6 mares susceptible to persistent breeding-induced endometritis .
METHODS	Six susceptible mares were selected based on their uterine inflammatory response to insemination .
METHODS	Mares were inseminated during 3 oestrous cycles with 1 10 ( 9 ) nonviable spermatozoa and 1 ) no additional treatment ( control ) , or in combination with 2 ) dexamethasone ( 50mg i.v. ) at the time of insemination , or 3 ) with mycobacterial cell wall extract ( 1.5 ml i.v. ) administered 24h prior to insemination .
METHODS	Mares received one treatment per cycle in randomised order , and each mare served as her own control .
METHODS	Endometrial biopsies were collected 6h after breeding , and quantitative polymerase chain reaction analysis for interleukin ( IL ) 1 , IL6 , interferon , IL10 and IL1RA was performed .
METHODS	Relative quantification values reported fold changes in mRNA expression from the control .
METHODS	Data were analysed using an ANOVA and significance was set at P < 0.05 .
RESULTS	Expression of IL1 mRNA was lower after treatment with dexamethasone ( P < 0.001 ) and mycobacterial cell wall extract ( P < 0.05 ) when compared with control .
RESULTS	No differences were detected in the mRNA expression of the other cytokines after any of the treatments .
CONCLUSIONS	Treatment with immune modulators alters endometrial mRNA expression of IL1 after insemination .
CONCLUSIONS	A better understanding of the mechanisms of immune modulation in the equine uterus can help to improve treatments for persistent breeding-induced endometritis .

###25376972
OBJECTIVE	Total knee arthroplasty ( TKA ) is often associated with severe pain .
OBJECTIVE	Different regional anesthetic techniques exist , all with varying degrees of motor blockade .
OBJECTIVE	We hypothesized that pain relief provided by the adductor canal block ( ACB ) could increase functional muscle strength .
METHODS	We included 50 TKA patients with severe movement-related pain ; defined as having visual analog scale pain score of greater than 60 mm during active flexion of the knee .
METHODS	The ACB group received an ACB with ropivacaine 0.2 % 30 mL and a femoral nerve block ( FNB ) with 30 mL saline .
METHODS	The FNB group received an ACB with 30 mL saline and an FNB with ropivacaine 0.2 % 30 mL .
METHODS	We compared the effect of the ACB versus FNB on maximum voluntary isometric contraction of the quadriceps muscle relative to a postoperative baseline value .
METHODS	Secondary end points were differences between groups in ability to ambulate and changes in pain scores ( Clinicaltrials.gov identifier NCT01922596 ) .
RESULTS	After block , the quadriceps maximum voluntary isometric contraction increased to 193 % ( 95 % confidence interval [ CI ] , 143-288 ) of the baseline value in the ACB group and decreased to 16 % ( 95 % CI , 3-33 ) in the FNB group with an estimated difference of 178 % ( 95 % CI , 136-226 ) , P < 0.0001 .
RESULTS	Pain scores were similar between groups .
RESULTS	Before block , 2 of 25 patients in each group were unable to perform the Timed-Up-and-Go test ; after block , this number increased to 7 of 25 in the FNB group and decreased to 0 of 25 in the ACB group .
CONCLUSIONS	Adductor canal block provides a clinically relevant and statistically significant increase in quadriceps muscle strength for patients in severe pain after TKA .

###24754066
OBJECTIVE	To make a comprehensive evaluation of the efficiency of eradication therapy in patients with coronary heart disease ( CHD ) concurrent with peptic ulcer disease ( PUD ) .
METHODS	The results of treatment were studied in 112 patients with CHD concurrent with PUD who were randomized into 3 groups : 1 ) adequate eradication therapy during treatment for CHD ; 2 ) antisecretory therapy ; 3 ) treatment for CHD only .
METHODS	The trend in the clinical symptoms of the diseases and the results of an exercise test were assessed .
RESULTS	After eradication therapy , Group 1 patients displayed a reduction in the frequency of angina attacks by 62.6 % and weekly nitroglycerin needs by 70.4 % and an increase in exercise tolerance by 45.3 % .
RESULTS	In Group 2 patients on antisecretory therapy , the similar indicators changed by 30.7 , 21.2 , and 26.5 % , respectively .
RESULTS	Group 3 patients showed no significant change in the study indicators .
CONCLUSIONS	The findings suggest that eradication therapy has a positive impact on the course of CHD , which manifests itself as an antianginal effect and hence a change in the clinical picture .

###24317850
OBJECTIVE	This paper examines the relationship between race , religiousness , spiritual well-being , antitumor treatment and preference for aggressive care among Black and White patients with advanced stage lung cancer receiving ambulatory cancer care in an urban setting .
METHODS	A cross-sectional exploration of patients enrolled in a Cleveland-based longitudinal study after initial diagnosis of advanced lung cancer were interviewed in Cleveland regarding religiousness , spiritual well-being , preferences for cardiopulmonary resuscitation ( CPR ) , goals of aggressive care , and willingness to tolerate adverse health states .
METHODS	Receipt of antitumor treatment was identified from medical records .
RESULTS	We analyzed data from 67 Black and 129 White patients ( N = 196 ) .
RESULTS	Regression analysis for CPR showed that race was not associated with preference for CPR ( OR = 1.12 , CI 0.44-2 .85 ) .
RESULTS	The odds of choosing CPR were three times higher among patients receiving antitumor treatment ( OR = 3.26 , CI 1.12-9 .44 ) .
RESULTS	Greater willingness to endure adverse health states was associated with higher spiritual well-being scores ( b = 0.12 , CI 0.01-0 .25 ) .
RESULTS	Choosing goals to extend life versus relieve pain was higher among persons with higher spiritual well-being as well ( RRR = 1.08 , CI 1.01-1 .16 ) , yet the relationship with religiousness was negative ( RRR = 0.46 , CI 0.22-0 .98 ) .
CONCLUSIONS	After controlling for multiple factors , race was associated only with CPR , but not with other measures of preference for aggressive care .
CONCLUSIONS	In addition , receipt of active antitumor treatment was positively associated with preference for CPR and spiritual well-being was important to setting end-of-life care goals and perspectives .
CONCLUSIONS	Future directions for tailoring end-of-life care decision-making initiatives should move beyond race and discussions of CPR alone and focus on a full spectrum of patient beliefs and preferences at the end of life .

###24708696
BACKGROUND	Continuous intraperitoneal insulin infusion ( CIPII ) with an implantable pump is a treatment option for patients with type 1 diabetes mellitus ( T1DM ) .
BACKGROUND	Aim of the present study was to describe the long-term course of glycaemic control , complications , health related quality of life ( HRQOL ) and treatment satisfaction among T1DM patients treated with CIPII .
METHODS	Nineteen patients that participated in a randomized cross-over trial comparing CIPII and subcutaneous ( SC ) therapy in 2006 were followed until 2012 .
METHODS	Laboratory , continuous glucose monitoring , HRQOL and treatment satisfaction measurements were performed at the start of the study , the end of the SC - , the end of the CIPII treatment phase in 2006 and during CIPII therapy in 2012 .
METHODS	Linear mixed models were used to calculate estimated values and to test differences between the moments in time .
RESULTS	In 2012 , more time was spent in hyperglycaemia than after the CIPII treatment phase in 2006 : 37 % ( 95 % CI 29 , 44 ) vs. 55 % ( 95 % CI 48 , 63 ) , mean difference 19.8 % ( 95 % CI 3.0 , 36.6 ) .
RESULTS	HbA1c was 65mmol/mol ( 95 % CI 60 , 71 ) at the end of the SC treatment phase in 2006 , 58mmol/mol ( 95 % CI 53 , 64 ) at the end of the CIPII treatment phase and 65mmol/mol ( 95 % CI 60 , 71 ) in 2012 , respectively ( p > 0.05 ) .
RESULTS	In 2012 , the median number of grade 2 hypoglycaemic events per week ( 1 ( 95 % CI 0 , 2 ) ) was still significantly lower than during prior SC therapy ( 3 ( 95 % CI 2 , 4 ) ) : mean change -1.8 ( 95 % CI -3.4 , -0.4 ) .
RESULTS	Treatment satisfaction with CIPII was better than with SC insulin therapy and HRQOL remained stable .
RESULTS	Pump or catheter dysfunction of the necessitated re-operation in 7 patients .
RESULTS	No mortality was reported .
CONCLUSIONS	After 6years of CIPII treatment , glycaemic regulation is stable and the number of hypoglycaemic events decreased compared to SC insulin therapy .
CONCLUSIONS	Treatment satisfaction with CIPII is superior to SC insulin therapy , HRQOL is stable and complications are scarce .
CONCLUSIONS	CIPII is a safe and effective treatment option for selected patients with T1DM , also on longer term .

###24758245
BACKGROUND	Atelectasis is common during and after general anaesthesia .
BACKGROUND	We hypothesized that a ventilation strategy , without recruitment manoeuvres , using a combination of continuous positive airway pressure ( CPAP ) or positive end-expiratory pressure ( PEEP ) and a reduced end-expiratory oxygen fraction ( FETO2 ) before ending mask ventilation with CPAP after extubation would reduce the area of postoperative atelectasis .
METHODS	Thirty patients were randomized into three groups .
METHODS	During induction and emergence , inspiratory oxygen fractions ( FIO2 ) were 1.0 in the control group and 1.0 or 0.8 in the intervention groups .
METHODS	No CPAP/PEEP was used in the control group , whereas CPAP/PEEP of 6 cmH2O was used in the intervention groups .
METHODS	After extubation , FIO2 was set to 0.30 in the intervention groups and CPAP was applied , aiming at FETO2 < 0.30 .
METHODS	Atelectasis was studied by computed tomography 25 min postoperatively .
RESULTS	The median area of atelectasis was 5.2 cm ( 2 ) ( range 1.6-12 .2 cm ( 2 ) ) and 8.5 cm ( 2 ) ( 3-23 .1 cm ( 2 ) ) in the groups given FIO2 1.0 with or without CPAP/PEEP , respectively .
RESULTS	After correction for body mass index the difference between medians ( 2.9 cm ( 2 ) ) was statistically significant ( confidence interval 0.2-7 .6 cm ( 2 ) , p = 0.04 ) .
RESULTS	In the group given FIO2 0.8 , in which seven patients were ex - or current smokers , the median area of atelectasis was 8.2 cm ( 2 ) ( 1.8-14 .7 cm ( 2 ) ) .
CONCLUSIONS	Compared with conventional ventilation , after correction for obesity , this ventilation strategy reduced the area of postoperative atelectasis in one of the intervention groups but not in the other group , which included a higher proportion of smokers .

###24330570
BACKGROUND	Androgen deprivation therapy ( ADT ) is a cornerstone in the treatment of advanced prostate cancer .
BACKGROUND	Adverse musculoskeletal and cardiovascular effects of ADT are widely reported and investigations into the potential of exercise to ameliorate the effects of treatment are warranted .
BACKGROUND	The ` Football Club ( FC ) Prostate ' study is a randomized trial comparing the effects of soccer training with standard treatment approaches on body composition , cardiovascular function , physical function parameters , glucose tolerance , bone health , and patient-reported outcomes in men undergoing ADT for prostate cancer .
METHODS	Using a single-center randomized controlled design , 80 men with histologically confirmed locally advanced or disseminated prostate cancer undergoing ADT for 6months or more at The Copenhagen University Hospital will be enrolled on this trial .
METHODS	After baseline assessments eligible participants will be randomly assigned to a soccer training group or a control group receiving usual care .
METHODS	The soccer intervention will consist of 12weeks of training 2-3 times/week for 45-60min after which the assessment protocol will be repeated .
METHODS	Soccer training will then continue bi-weekly for an additional 20weeks at the end of which all measures will be repeated to allow for additional analyses of long-term effects .
METHODS	The primary endpoint is changes in lean body mass from baseline to 12weeks assessed by dual X-ray absorptiometry scan .
METHODS	Secondary endpoints include changes of cardiovascular , metabolic , and physical function parameters , as well as markers of bone metabolism and patient-reported outcomes .
CONCLUSIONS	The FC Prostate trial will assess the safety and efficacy of a novel soccer-training approach to cancer rehabilitation on a number of clinically important health outcomes in men with advanced prostate cancer during ADT .
CONCLUSIONS	The results may pave the way for innovative , community-based interventions in the approach to treating prostate cancer .
BACKGROUND	ClinicalTrials.gov : NCT01711892 .

###24890138
OBJECTIVE	Thiazolidinediones reduce ectopic fat , increase adiponectin and reduce inflammatory adipokines , fatty acids and glucose in people with Type 2 diabetes .
OBJECTIVE	We aimed to measure these effects in people with impaired fasting glucose and/or impaired glucose tolerance .
METHODS	After approximately 3.5 years of exposure to rosiglitazone 8 mg ( n = 88 ) or placebo ( n = 102 ) , 190 DREAM trial participants underwent abdominal computed tomography and dual-energy X-ray absorptiometry scans .
METHODS	Visceral and subcutaneous adipose tissue areas , estimated hepatic fat content , total fat and lean mass were calculated and changes in levels of fasting adipokines , free fatty acids , glucose and post-load glucose were assessed .
RESULTS	Compared with the placebo , participants on rosiglitazone had no difference in lean mass , had 4.1 kg more body fat ( P < 0.0001 ) and 31 cm ( 2 ) more subcutaneous abdominal adipose tissue area ( P = 0.007 ) .
RESULTS	Only after adjusting for total fat , participants on rosiglitazone had 23 cm less visceral adipose tissue area ( P = 0.01 ) and an 0.08-unit higher liver : spleen attenuation ratio ( i.e. less hepatic fat ; P = 0.02 ) than those on the placebo .
RESULTS	Adiponectin increased by 15.0 g/ml with rosiglitazone and by 0.4 g/ml with placebo ( P < 0.0001 ) .
RESULTS	Rosiglitazone 's effect on fat distribution was not independent of changes in adiponectin .
RESULTS	Rosiglitazone 's effects on fasting ( -0.36 mmol/l ; P = 0.0004 ) and 2-h post-load glucose ( -1.21 mmol/l ; P = 0.0008 ) were not affected by adjustment for fat distribution or changes in adiponectin or free fatty acids .
CONCLUSIONS	In people with impaired fasting glucose/impaired glucose tolerance , rosiglitazone is associated with relatively less hepatic and visceral fat , increased subcutaneous fat and increased adiponectin levels .
CONCLUSIONS	These effects do not appear to explain the glucose-lowering effect of rosiglitazone .

###24792011
OBJECTIVE	The aim of this study was to compare the preperitoneal versus the preaponeurotic mesh positioning in open paraumbilical hernia repair .
METHODS	During the period from January 2011 until July 2012 , 60 adult patients were randomly assigned to two equal groups .
METHODS	The patients in group A were treated by preperitoneal mesh repair and those in group B underwent preaponeurotic mesh repair .
METHODS	Both groups were assessed and compared .
RESULTS	There were no significant differences between the two groups in the demographics , hernia characteristics , risk factors , type of anesthesia , American Society of Anesthesiologists score or the mean follow-up period .
RESULTS	The length of the operation was significantly shorter in group B than in group A ( P value = 0.01 ) .
RESULTS	There were no significant differences in the early postoperative complications except for the development of a seroma , which developed only in group B ( P value = 0.044 ) .
RESULTS	The postoperative pain was significantly lower in group A than in group B ( P value = 0.01 ) .
RESULTS	The time of return to normal daily activities was significantly shorter in group A than in group B ( P value = 0.001 ) .
CONCLUSIONS	The preperitoneal mesh placement during the repair of paraumbilical hernias is superior to the preaponeurotic placement , because it is associated with fewer complications , less pain and a shorter time of return to normal daily activities .

###24853585
BACKGROUND	Subphenotypes have been identified within heterogeneous diseases such as asthma and breast cancer , with important therapeutic implications .
BACKGROUND	We assessed whether subphenotypes exist within acute respiratory distress syndrome ( ARDS ) , another heterogeneous disorder .
METHODS	We used data from two ARDS randomised controlled trials ( ARMA trial and ALVEOLI trial ) , sponsored by the National Heart , Lung , and Blood Institute .
METHODS	We applied latent class modelling to identify subphenotypes using clinical and biological data .
METHODS	We modelled data from both studies independently .
METHODS	We then tested the association of subphenotypes with clinical outcomes in both cohorts and with the response to positive end-expiratory pressure ( PEEP ) in the ALVEOLI cohort .
RESULTS	We analysed data for 1022 patients : 473 in the ARMA cohort and 549 in the ALVEOLI cohort .
RESULTS	Independent latent class models indicated that a two-class ( ie , two subphenotype ) model was the best fit for both cohorts .
RESULTS	In both cohorts , we identified a hyperinflammatory subphenotype ( phenotype 2 ) that was characterised by higher plasma concentrations of inflammatory biomarkers , a higher prevalence of vasopressor use , lower serum bicarbonate concentrations , and a higher prevalence of sepsis than phenotype 1 .
RESULTS	Participants in phenotype 2 had higher mortality and fewer ventilator-free days and organ failure-free days in both cohorts than did those in phenotype 1 ( p < 0007 for all ) .
RESULTS	In the ALVEOLI cohort , the effects of ventilation strategy ( high PEEP vs low PEEP ) on mortality , ventilator-free days and organ failure-free days differed by phenotype ( p = 0049 for mortality , p = 0018 for ventilator-free days , p = 0003 for organ-failure-free days ) .
CONCLUSIONS	We have identified two subphenotypes within ARDS , one of which is categorised by more severe inflammation , shock , and metabolic acidosis and by worse clinical outcomes .
CONCLUSIONS	Response to treatment in a randomised trial of PEEP strategies differed on the basis of subphenotype .
CONCLUSIONS	Identification of ARDS subphenotypes might be useful in selecting patients for future clinical trials .
BACKGROUND	National Institutes of Health .

###24852376
BACKGROUND	Influenza is an important cause of morbidity and mortality worldwide .
BACKGROUND	Treatment options are scarce , and new drugs with novel mechanisms of action are needed .
BACKGROUND	We aimed to assess the efficacy and safety of nitazoxanide , a thiazolide anti-infective , for treatment of acute uncomplicated influenza .
METHODS	We did a double-blind , randomised , placebo-controlled , phase 2b/3 trial in 74 primary care clinics in the USA between Dec 27 , 2010 , and April 30 , 2011 .
METHODS	We enrolled participants aged 12-65 years with fever , at least one respiratory symptom , and one constitutional symptom of influenza within 48 h of symptom onset .
METHODS	We randomly assigned participants to receive either nitazoxanide 600 mg , nitazoxanide 300 mg , or placebo twice daily for 5 days , ( ratio 1:1:1 ) and followed them up for 28 days .
METHODS	Randomisation lists were computer generated and done in blocks of three .
METHODS	Sponsor , investigators , study monitors , patients , and laboratory personnel were all masked to treatment allocation in the study .
METHODS	The primary endpoint was the time from first dose to alleviation of symptoms .
METHODS	The primary analysis was by intention-to-treat for participants with influenza infection confirmed by RT-PCR or culture at baseline .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01227421 .
RESULTS	Of 650 participants screened , 624 ( 96 % ) were enrolled .
RESULTS	Of these , 212 were randomly assigned to receive placebo twice a day , 201 to receive nitazoxanide 300 mg twice a day , and 211 to receive nitazoxanide 600 mg a day .
RESULTS	The median duration of symptoms for participants receiving placebo was 1167 h ( 95 % CI 1081-1221 ) compared with 955 h ( 840-1080 ; p = 00084 ) for those receiving 600 mg nitazoxanide and 1091 h ( 961-1295 , p = 052 ) for those receiving 300 mg nitazoxanide .
RESULTS	Adverse events were similar between the three groups , the most common being headache reported by 24 ( 11 % ) of 212 patients enrolled in placebo group , 12 ( 6 % ) of 201 patients in the low-dose group , and 17 ( 8 % ) of 211 patients in the high-dose group , or diarrhoea , reported by seven ( 3 % ) patients in the placebo group , four ( 2 % ) patients enrolled in the low-dose group , and 17 ( 8 % ) patients in the high-dose group .
CONCLUSIONS	Treatment with nitazoxanide 600 mg twice daily for 5 days was associated with a reduction of the duration of symptoms in participants with acute uncomplicated influenza .
CONCLUSIONS	Further studies are warranted to confirm these findings and to assess efficacy of the drug alone or in combination with existing drugs in seriously ill patients and those at risk of influenza complications .
BACKGROUND	Romark Laboratories LC .

###24313583
OBJECTIVE	The effects on plaque parameters of sugar free chewing-gums ( CG ) sweetened with either maltitol or xylitol were assessed to better understand the role polyols can play in dental caries prevention .
METHODS	A double-blind , parallel , randomised , controlled study was conducted in China .
METHODS	Subjects ( N = 258 , age = 13 to 15 years-old ) were divided into 4 groups : 2 receiving polyols CG , containing respectively maltitol or xylitol , a group receiving gum base ( placebo ) and a negative control group not receiving any gum .
METHODS	CG were chewed for 30 days .
METHODS	This corresponds to a 10 g consumption of polyol per day .
METHODS	Plaque parameters ( growth , pH , bacteria and insoluble glucans ) were evaluated throughout the experimental period .
RESULTS	All parameters studied were significantly modified with gum base compared to no-gum : plaque pH increased ; plaque growth , bacteria ( S. mutans , S. sobrinus , A. viscosus and Lactobacillus ) and insoluble glucans decreased .
RESULTS	Maltitol and xylitol CG led similarly to a higher plaque pH ( AUC , p0 .05 ) on short ( at baseline after the first CG consumption ) and long term ( after 4 weeks of daily CG consumption ) , with or without saliva stimulation compared to both control and placebo groups .
RESULTS	They led to a decrease in plaque growth ( p = 0.02 ) over the experimental period compared to controls .
RESULTS	Moreover , they significantly reduced the concentration of 4 cariogenic bacteria species ( p0 .05 ) in dental plaque compared to gum base .
CONCLUSIONS	Sugar free CG sweetened with either maltitol or xylitol can similarly reduce plaque acidogenicity compared to gum base through a decrease in oral bacteria presence .
CONCLUSIONS	The use of a gum base placebo allowed to isolate effects on parameters involved in dental caries development specific to maltitol and xylitol , and to show these effects were similar .

###24795254
BACKGROUND	The prevalence of non-alcoholic fatty liver disease is increasing worldwide and an effective and safe pharmacological treatment is needed .
BACKGROUND	We investigated whether inhibition of 11-hydroxysteroid dehydrogenase type 1 ( 11-HSD1 , also known as HSD11B1 ) by RO5093151 could safely and effectively decrease liver-fat content in patients with this disorder .
METHODS	We did this phase 1b trial at four centres in Germany and Austria .
METHODS	Participants with non-alcoholic fatty liver disease ( defined as ( 1 ) H magnetic resonance spectroscopy liver-fat content > 556 % ) , insulin resistance ( homoeostatic model assessment of insulin resistance [ HOMA-IR ] of at least 20 mmol/LmU/L ) , BMI greater than 27 kg/m ( 2 ) , and aged 35-65 years were randomly assigned by interactive voice response system in a 1:1 ratio , stratified for triglyceride concentration ( < 17 mmol/L or 17 mmol/L ) , to oral RO5093151 ( 200 mg twice daily ) or matching placebo for 12 weeks .
METHODS	The main exclusion criteria were other liver diseases , aspartate aminotransferase or alanine aminotransferase concentrations of more than two and a half times the upper limit of normal , history of diabetes or bariatric surgery , and use of weight lowering drugs .
METHODS	Participants and investigators were masked to assignment throughout the study .
METHODS	The primary endpoint was change in liver-fat content from baseline to week 12 .
METHODS	Efficacy analysis was by modified intention to treat , including all patients who received at least one dose of study drug and had a baseline and follow-up measurement of liver-fat content .
METHODS	Safety analyses included all patients who received at least one dose of study drug .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01277094 .
RESULTS	We did this trial between Jan 13 , 2011 , and March 28 , 2012.41 patients were randomly assigned to RO5093151 and 41 to placebo .
RESULTS	35 patients in the RO5093151 group and 39 in the placebo group were included in the efficacy analysis .
RESULTS	Mean liver-fat content decreased in the RO5093151 group ( from 1675 % [ SD 867 ] to 1428 % [ 889 ] ) , but not in the placebo group ( from 1853 % [ 1000 ] to 1846 % [ 1078 ] , p = 002 for between group difference ) .
RESULTS	26 participants ( 65 % ) in the RO5093151 group had adverse events , compared with 21 ( 53 % ) in the placebo group .
RESULTS	The most common adverse events were gastrointestinal disorders ( 12 patients [ 30 % ] in the RO5093151 group vs seven [ 18 % ] in the placebo group ) , and infections and infestations ( eight [ 20 % ] vs nine [ 23 % ] ) .
RESULTS	Nervous system disorders occurred in significantly more patients in the RO5093151 group than in the placebo group ( nine [ 23 % ] vs two [ 5 % ] ; p = 002 ) ; all other differences in adverse events were non-significant .
RESULTS	One participant ( 3 % ) in the placebo group and three participants ( 8 % ) in the RO5093151 group had serious adverse events .
RESULTS	All serious adverse events were deemed unrelated to study treatment .
CONCLUSIONS	Inhibition of 11-HSD1 by RO5093151 was effective and safe in reducing liver-fat content , suggesting that targeting of 11-HSD1 might be a promising approach for the treatment of non-alcoholic fatty liver disease .
BACKGROUND	F Hoffmann-La Roche .

###24656645
BACKGROUND	Bone marrow mononuclear cell ( BMMC ) transplantation for heart failure has shown inconsistent therapeutic efficacy .
METHODS	We enrolled 104 ischemic heart failure patients scheduled for coronary artery bypass surgery ( CABG ) .
METHODS	After 4 - to 12-week pharmacotherapy optimization , 39 patients with left ventricular ejection fraction ( LVEF ) of 45 % received injections of BMMC or vehicle intra-operatively into the myocardial infarction border area in a randomized , double-blind manner .
RESULTS	The median number of cells injected was 8.4 10 ( 8 ) ( interquartile range [ IQR ] : 5.2 10 ( 8 ) to 13.5 10 ( 8 ) ) .
RESULTS	We measured LV function and myocardial scar size by magnetic resonance imaging ( MRI ) , and viability by positron emission tomography ( PET ) and single-photon emission computed tomography ( SPECT ) , pre-operatively and after 1-year follow-up .
RESULTS	LVEF , the pre-defined primary end-point measure , improved by a median of 5.6 % in the control group ( IQR 0.2 to 10.1 ) and by 4.8 % in the BMMC group ( IQR -0.5 to 8.2 ) ( p = 0.59 ) .
RESULTS	Wall thickening in injected segments rose by a median of 4.5 % among controls ( IQR -18.1 to 23.9 ) and by 5.5 % in the BMMC group ( IQR -6.6 to 26.5 ) ( p = 0.68 ) .
RESULTS	Changes in viability by PET and SPECT did not differ between groups .
RESULTS	Myocardial scar size by MRI in injected segments rose by a median of 5.1 % among controls ( IQR -3.3 to 10.8 ) , but fell by 13.1 % in the BMMC group ( IQR -21.4 to -6.5 ) ( p = 0.0002 ) .
CONCLUSIONS	BMMC therapy combined with CABG failed to improve LV systolic function , or viability , despite reducing myocardial scar size .

###24901279
OBJECTIVE	To assess the efficacy of moxibustion ( heating of the acupuncture needle with an igniting charcoal moxa stick ) with acupuncture for version of breech presentations after 33 4/7 weeks of gestation to reduce their rate at 37 weeks of gestation and at delivery .
METHODS	This was a randomized placebo-controlled single-blind trial including 328 pregnant women recruited in a university hospital center between 33 4/7 and 35 4/7 weeks of gestation .
METHODS	Moxibustion with acupuncture or inactivated laser ( placebo ) treatment was applied to point BL 67 for six sessions .
METHODS	The principal endpoint was the percentage of fetuses in breech presentation at 37 2/7 weeks of gestation .
RESULTS	The study included 328 women randomized into two groups : moxibustion with acupuncture ( n = 164 ) or placebo ( n = 164 ) .
RESULTS	The percentage of fetuses in breech presentation at 37 2/7 weeks of gestation was not significantly different in both groups ( 72.0 in the moxibustion with acupuncture group compared with 63.4 % in the placebo group , relative risk 1.13 , 95 % confidence interval 0.98-1 .32 , P = .10 ) .
CONCLUSIONS	Treatment by moxibustion with acupuncture was not effective in correcting breech presentation in the third trimester of pregnancy .
BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT01487590 .

###25901479
OBJECTIVE	To evaluate the effects of different dosing intervals on multiple-dose pharmacokinetics , and safety and tolerability of fentanyl pectin nasal spray ( FPNS ) .
METHODS	This was an open-label study in healthy volunteers .
METHODS	Five FPNS treatments ( 1 100 g ; 2 100 g at 4 - , 2 - , and 1-hour intervals , and 8 100 g consecutively ) were administered to the right nostril , with a 3-day washout period .
METHODS	Blood samples were collected at predose and up to 1,440 minutes postdose .
METHODS	Plasma fentanyl concentrations were determined .
METHODS	Pharmacokinetic parameters-peak concentration ( C ( max ) ) , time to C ( max ) ( t ( max ) ) , and area under the concentration-time curve ( AUC ) - were derived using noncompartmental method .
METHODS	For the two-dose regimens , pharmacokinetic parameters were compared between doses using a paired t-test with p < 0.05 as statistically significant .
RESULTS	Thirteen subjects were enrolled and 10 completed the study .
RESULTS	Median tmax was 10-15 minutes across five regimens .
RESULTS	Cmax post the second dose significantly increased for 1-hour ( p < 0.0001 ) and 2-hour ( p < 0.001 ) but not 4-hour intervals ( p = 0.462 ) .
RESULTS	C ( max ) and AUC ( 0-24 ) following 8 100 g were approximately fivefold of those following 1 100 g. Dizziness ( 11.9 percent ) and somnolence ( 4.9 percent ) were most common adverse events ( AEs ) .
RESULTS	12.9 percent of patients discontinued due to AEs .
CONCLUSIONS	FPNS exhibited consistently rapid t ( max ) .
CONCLUSIONS	When intervals between two doses were shorter , the difference in C ( max ) between the first and second dose was larger .
CONCLUSIONS	All regimens of FPNS were well tolerated .
CONCLUSIONS	Exposure reached a plateau after eight consecutive doses , suggesting potential limited absorption through the nasal mucosa .

###25245591
BACKGROUND	Transcranial random noise stimulation ( tRNS ) is an innovative technique of non-invasive electrical stimulation .
BACKGROUND	tRNS over the parietal cortex has improved cognitive function in healthy controls and , applied to the auditory cortex , tRNS has shown beneficial effects on tinnitus .
OBJECTIVE	Here we aimed to investigate the effects of tRNS over the auditory cortex on resting state and evoked activity in healthy subjects .
METHODS	We used EEG to measure tRNS induced changes in resting state activity and in auditory steady state responses ( ASSRs ) .
METHODS	Stimuli were 1000 Hz carrier frequency tones , amplitude modulated at 20 Hz and 40 Hz and applied in randomized order .
METHODS	Fourteen subjects participated in a placebo-controlled randomized design study ; each received 20 min of tRNS applied over auditory cortices with 2 mA , with a one week interval between real and sham stimulation .
RESULTS	We found a significant increase in the ASSR in response to 40 Hz frequency modulated tone and a non-significant trend toward an increase in mean theta band power and variability of the theta band power for the resting state data .
CONCLUSIONS	Our finding of tRNS induced increased excitability in the auditory cortex parallels previous findings of tRNS effects on motor cortex excitability and is in line with current concepts of tRNS mechanisms such as increase of stochastic resonance .

###24509273
OBJECTIVE	The purpose of this study was assess the effect of evolocumab ( AMG 145 ) on lipoprotein ( Lp ) ( a ) from a pooled analysis of 4 phase II trials .
BACKGROUND	Lp ( a ) , a low-density lipoprotein ( LDL ) particle linked to the plasminogen-like glycoprotein apolipoprotein ( a ) , shows a consistent and independent positive association with cardiovascular disease risk in epidemiological studies .
BACKGROUND	Current therapeutic options to reduce Lp ( a ) are limited .
METHODS	A pooled analysis of data from 1,359 patients in 4 phase II trials assessed the effects of evolocumab , a fully human monoclonal antibody to PCSK9 , on Lp ( a ) , the relationship between Lp ( a ) and lowering of low-density lipoprotein cholesterol ( LDL-C ) and apolipoprotein B , and the influence of background statin therapy .
METHODS	Lp ( a ) was measured using a standardized isoform-independent method .
RESULTS	Evolocumab treatment for 12 weeks resulted in significant ( p < 0.001 ) mean ( 95 % confidence interval ) dose-related reductions in Lp ( a ) compared to control : 29.5 % ( 23.3 % to 35.7 % ) and 24.5 % ( 20.4 % to 28.7 % ) with 140 mg and 420 mg , dosed every 2 and 4 weeks , respectively , with no plateau of effect .
RESULTS	Lp ( a ) reductions were significantly correlated with percentages of reductions in LDL-C ( Spearman correlation coefficient , 0.5134 ; p < 0.001 ) and apolipoprotein B ( Spearman correlation coefficient , 0.5203 ; p < 0.001 ) .
RESULTS	Mean percentage reductions did not differ based on age or sex but the trend was greater in those patients taking statins .
CONCLUSIONS	Inhibition of PCSK9 with evolocumab resulted in significant dose-related reductions in Lp ( a ) .
CONCLUSIONS	While the mean percentage of reduction was significantly greater in those patients with baseline Lp ( a ) of 125 nmol/l , the absolute reduction was substantially larger in those with levels > 125 nmol/l .

###25192980
BACKGROUND	The aim of this study was to assess whether the combination of low frequency repetitive transcranial magnetic stimulation ( rTMS ) and venlafaxine ( 150-225 mg/day ) is effective and safe for treatment-resistant unipolar depression ( TRD ) .
METHODS	In a multicenter ( 18 centers ) randomized double blind controlled trial with three arms , 170 patients were allocated to receive active rTMS combined with active venlafaxine ( n = 55 ) , active rTMS combined with placebo venlafaxine ( n = 60 ) or sham rTMS combined with active venlafaxine ( n = 55 ) .
METHODS	The patients received once daily sessions of active or sham 1 Hz rTMS applied over the right dorsolateral prefrontal cortex ( 360 pulses/day delivered at 120 % of the resting motor threshold ) for two to six weeks ; rTMS was combined with active or sham venlafaxine ( mean dose : 179.0 36.6 mg/day ) .
METHODS	The primary outcome was the number of patients who achieved remission , which was defined as an HDRS17 score < 8 .
RESULTS	We reported a similar significant antidepressant effect in the 3 groups ( P < 10 ( -6 ) ) , with a comparable delay of action and a comparable number of remitters at the endpoint ( 28 % in the combination group , 41 % in the rTMS group and 43 % in the venlafaxine group ; P = 0.59 ) .
CONCLUSIONS	Low frequency rTMS appears to be as effective as venlafaxine and as effective as the combination of both treatments for TRD .
CONCLUSIONS	Because of its short session duration ( the duration of one session was 8.5 min ) and its safety , slow rTMS might be a useful alternative treatment for patients with TRD .

###25157647
BACKGROUND	Several clinical trials have demonstrated the safety and effectiveness of oral tenofovir disoproxil fumarate ( TDF ) , with or without emtricitabine ( FTC ) , as pre-exposure prophylaxis ( PrEP ) for reducing the risk of HIV acquisition .
BACKGROUND	Adherence to the study product was insufficient to demonstrate the effectiveness of FTC/TDF in 2 PrEP clinical trials conducted among women ( FEM-PrEP and the Vaginal and Oral Interventions to Control the Epidemic study ) , but further analyses of adherence in these studies may inform PrEP demonstration projects and future HIV prevention clinical trials .
METHODS	We randomly selected a subcohort of 150 participants randomized to FTC/TDF in 3 FEM-PrEP sites ( Bondo , Kenya ; Bloemfontein , South Africa ; and Pretoria , South Africa ) to examine adherence levels over time and to assess factors associated with adherence , based on plasma tenofovir and intracellular tenofovir diphosphate drug concentrations in specimens collected at 4-week visit intervals .
RESULTS	We observed drug concentrations consistent with good adherence in 28.5 % of all visit intervals when drug was available to use , but only 12 % of participants achieved good adherence throughout their study participation .
RESULTS	In multivariate analysis , the Bloemfontein site [ odds ratio ( OR ) : 2.43 ; 95 % confidence interval ( CI ) : 1.32 to 4.48 ] and liking the pill color ( OR : 2.93 ; 95 % CI : 1.18 to 7.27 ) were positively associated with good adherence , whereas using oral contraceptive pills at enrollment was negatively associated with good adherence ( OR : 0.37 ; 95 % CI : 0.18 to 0.74 ) .
CONCLUSIONS	Most participants did not regularly adhere to the study product throughout their trial participation , although a small minority did .
CONCLUSIONS	Few factors associated with good adherence to the study product were identified in FEM-PrEP .

###25627150
METHODS	Randomized crossover laboratory study .
OBJECTIVE	To determine the effects of ankle destabilization devices on surface electromyography ( sEMG ) measures of selected lower extremity muscles during functional exercises in participants with chronic ankle instability .
BACKGROUND	Ankle destabilization devices are rehabilitation tools that can be worn as a boot or sandal to increase lower extremity muscle activation during walking in healthy individuals .
BACKGROUND	However , they have not been tested in a population with pathology .
METHODS	Fifteen adults with chronic ankle instability participated .
METHODS	Surface electromyography electrodes were located over the anterior tibialis , fibularis longus , lateral gastrocnemius , rectus femoris , biceps femoris , and gluteus medius .
METHODS	The activity level of these muscles was recorded in a single testing session during unipedal stance with eyes closed , the Star Excursion Balance Test , lateral hops , and treadmill walking .
METHODS	Each task was performed under 3 conditions : shod , ankle destabilization boot , and ankle destabilization sandal .
METHODS	Surface electromyography signal amplitudes were measured for each muscle during each exercise for all 3 conditions .
RESULTS	Participants demonstrated a significant increase , with moderate to large effect sizes , in sEMG signal amplitude of the fibularis longus in the ankle destabilization boot and ankle destabilization sandal conditions during the unipedal eyes-closed balance test , the Star Excursion Balance Test in the anterior and posteromedial directions , lateral hops , and walking , when compared to the shod condition .
RESULTS	Both devices also resulted in an increase in sEMG signal amplitudes , with large effect sizes of the lateral gastrocnemius , rectus femoris , biceps femoris , and gluteus medius during the unipedal-stance-with-eyes-closed test , compared to the shod condition .
CONCLUSIONS	Wearing ankle destabilization devices caused greater muscle activation during functional exercises in individuals with chronic ankle instability .
CONCLUSIONS	Based on the magnitude of the effect , there were consistent increases in fibularis longus sEMG amplitudes during the unipedal eyes-closed balance test , the Star Excursion Balance Test in the anterior and posteromedial directions , and pre-initial contact and post-initial contact during lateral hops and walking .

###25003980
BACKGROUND	Oxygen is commonly administered after extubation .
BACKGROUND	Although several devices are available , data about their clinical efficacy are scarce .
OBJECTIVE	To compare the effects of the Venturi mask and the nasal high-flow ( NHF ) therapy on PaO2/FiO2SET ratio after extubation .
OBJECTIVE	Secondary endpoints were to assess effects on patient discomfort , adverse events , and clinical outcomes .
METHODS	Randomized , controlled , open-label trial on 105 patients with a PaO2/FiO2 ratio less than or equal to 300 immediately before extubation .
METHODS	The Venturi mask ( n = 52 ) or NHF ( n = 53 ) were applied for 48 hours postextubation .
RESULTS	PaO2/FiO2SET , patient discomfort caused by the interface and by symptoms of airways dryness ( on a 10-point numerical rating scale ) , interface displacements , oxygen desaturations , need for ventilator support , and reintubation were assessed up to 48 hours after extubation .
RESULTS	From the 24th hour , PaO2/FiO2SET was higher with the NHF ( 287 74 vs. 247 81 at 24 h ; P = 0.03 ) .
RESULTS	Discomfort related both to the interface and to airways dryness was better with NHF ( respectively , 2.6 2.2 vs. 5.1 3.3 at 24 h , P = 0.006 ; 2.2 1.8 vs. 3.7 2.4 at 24 h , P = 0.002 ) .
RESULTS	Fewer patients had interface displacements ( 32 % vs. 56 % ; P = 0.01 ) , oxygen desaturations ( 40 % vs. 75 % ; P < 0.001 ) , required reintubation ( 4 % vs. 21 % ; P = 0.01 ) , or any form of ventilator support ( 7 % vs. 35 % ; P < 0.001 ) in the NHF group .
CONCLUSIONS	Compared with the Venturi mask , NHF results in better oxygenation for the same set FiO2 after extubation .
CONCLUSIONS	Use of NHF is associated with better comfort , fewer desaturations and interface displacements , and a lower reintubation rate .
CONCLUSIONS	Clinical trial registered with www.clinicaltrials.gov ( NCT 01575353 ) .

###24490521
OBJECTIVE	To analysis the clinical characteristics of children with cough variation asthma ( CVA ) who received treatments with Carboxymethl starch sodium solution and inhaled Glucocorticoid budesonide .
METHODS	A total of 96 children with CVA were divided into two group randomly .
METHODS	The control group ( n = 49 ) received inhaled budesonide treatment ( 500 microg/times in 1-5 years old children , 1 mg/times and 2 times/day in 6-14 years old children over a 12 week period ) .
METHODS	The children in treatment group ( n = 47 ) were given carboxymethl starch sodium solution ( 3 mL/times in 1-3 years old children , 5 mL/times in 4-7 years old children , 7 mL/times in 8-14 years old children , 3 times/day ) in addition to the inhaled budesonide treatment .
METHODS	Observations were made on clinical therapeutic effects , cough score and the level of IgE 4 weeks , 8 weeks and 12 weeks after the treatments , respectively .
METHODS	Recurrence rate and adverse reactions were investigated .
RESULTS	Compared with the control group , the treatment group had significantly improved clinical characteristics after 8 weeks and 12 weeks of treatments ( P < 0.05 ) , and reduced cough scores after 4 weeks , 8 weeks and 12 weeks of treatments ( P < 0.05 ) .
RESULTS	The IgE level of the children in the treatment group was significantly lower than the controls after 12 weeks of treatments ( P < 0.05 ) .
RESULTS	The treatment group also had significantly lower recurrence rate and adverse reactions than the controls ( P < 0.05 ) .
CONCLUSIONS	Carboxymethl starch sodium solution can boost the clinical efficiency of inhaled budesonide in the treatment of children with cough variant asthma .
CONCLUSIONS	It is safe and effectual .

###24662812
OBJECTIVE	To determine any differences between the prevalence of adolescent idiopathic scoliosis in ballet dancers who are girls compared with age-matched nondancers , and to establish if any relations exist between the presence of scoliosis and generalized joint hypermobility , age of menarche , body mass index ( BMI ) , and the number of hours of dance training per week .
METHODS	Cross-sectional , matched pair study .
METHODS	Dance school .
METHODS	Dancers ( n = 30 ) between the ages of 9 and 16 years were recruited from a certified dance school in Western Australia ; each dancer provided a consenting age-matched nondancer ( n = 30 ) .
METHODS	Not applicable .
METHODS	Measurements were taken for angle of trunk rotation using a scoliometer ( presence of scoliosis ) and for height and weight to produce generalized joint hypermobility using Beighton criteria and an age-adjusted BMI , respectively .
METHODS	A subjective questionnaire regarding age of menarche and participation in dance and other sports was completed .
RESULTS	Thirty percent of dancers tested positive for scoliosis compared with 3 % of nondancers .
RESULTS	Odds ratio calculations suggest that dancers were 12.4 times more likely to have scoliosis than nondancers of the same age .
RESULTS	There was a higher rate of hypermobility in the dancer group ( 70 % ) compared with the nondancers ( 3 % ) ; however , there were no statistically significant relations between scoliosis and hypermobility , age of menarche , BMI , or hours of dance per week .
CONCLUSIONS	Adolescent dancers , similar to adult dancers , are at significantly higher risk of developing scoliosis than nondancers of the same age .
CONCLUSIONS	Vigilant screening and improved education of dance teachers and parents of dance students may be beneficial in earlier detection and , consequently , reducing the risk of requiring surgical intervention .

###24331988
BACKGROUND	The aim of this study was to evaluate the effect of working length determination methods , electronic apex locator and digital radiography , on postoperative pain .
METHODS	Two hundred twenty patients with asymptomatic single-rooted vital teeth were randomly assigned to 2 groups according to the method used for working length determination , the radiographic group and the electronic apex locator group .
METHODS	After working length determination , chemomechanical preparation was performed in a crown-down technique with ProTaper instruments .
METHODS	A master cone radiograph was taken .
METHODS	Canals were obturated with gutta-percha and sealer by using a lateral compaction technique .
METHODS	Postoperative pain was assessed after 4 , 6 , 12 , 24 , and 48hours by using a 4-point pain intensity scale .
METHODS	In addition , patients were asked to record the number of days necessary to achieve complete pain resolution .
RESULTS	Postoperative pain during the 4-hour to 48-hour interval studied was not significantly different ( P > .05 ) between groups .
RESULTS	The mean times for pain dissipation in the radiographic and electronic apex locator groups were 3.37 2.79 and 3.88 3.34 days , respectively .
RESULTS	The difference between groups was not statistically significant ( P > .05 ) .
CONCLUSIONS	There is no difference in postoperative pain between working length measurement methods by using an electronic apex locator or digital radiography .
CONCLUSIONS	The reduced exposure to radiation by using apex locator may be a factor that influences a dentist 's decision to choose the electronic apex locator over radiography .

###25683312
OBJECTIVE	Rehabilitation has been reported to improve pain and disability for patients after lumbar surgery .
OBJECTIVE	However , studies to investigate the rehabilitation intervention for lumbar decompression surgery during hospitalization are scarce .
OBJECTIVE	The aim of this study was to examine outcomes of perioperative rehabilitation intervention for patients who underwent lumbar decompression surgery ( LDS ) .
METHODS	Patients aged 18-65 years old who received their first LDS were randomized into the perioperative rehabilitation group ( PG ) or control group ( CG ) .
METHODS	The PG received rehabilitation intervention during hospitalization for lumbar decompression surgery .
METHODS	Pain , functional capacity , Roland-Morris Disability Questionnaire ( RMDQ ) , and Short-Form Health Survey ( SF-12 ) were assessed on admission , at discharge , and at follow-ups one month , three months , and six months after surgery .
METHODS	Two-way repeated measures ANOVAs were used for statistical analysis .
RESULTS	A total of 60 patients scheduled for decompression surgery for lumbar stenosis were enrolled into the study .
RESULTS	After surgery , the PG showed significant pain relief and improvement of disability as well as quality of life , but there were no significant functional improvements compared with the CG .
CONCLUSIONS	The findings of this study indicate that the rehabilitation intervention during hospitalization improves pain intensity as well as disability and quality of life , yet has limited effects on the functional performance over time up to six months post-surgery in patients who received LDS .
CONCLUSIONS	The study suggest that rehabilitation interventions during hospitalization must include regular support for patient adherence to the intervention program and focus on task-oriented programs for lower extremities such as closed-chain exercises in functional postures .

###25948722
OBJECTIVE	The 5-HT1B / D agonists ( triptans ) are specific headache medications that have no effect on pain as such .
OBJECTIVE	Although they are routinely used in the treatment of acute migraine attacks , the underlying mechanisms of action are still a matter of debate .
METHODS	Forty-three healthy participants underwent fMRI while receiving trigemino-nociceptive stimulation and control stimuli in a standardized fMRI paradigm .
METHODS	Using a crossover , double-blind , placebo-controlled design , 21 participants ( 10 women , mean age 26.9 , range 20-37 years ) received sumatriptan and 22 participants ( 11 women , mean age 25.5 , range 22-32 years ) received acetylsalicylic acid ( ASA ) .
METHODS	Administration of medication and saline was randomized between participants of each group resulting in half of the participants receiving saline and the other half receiving the respective medication during the first fMRI data acquisition .
RESULTS	While mean pain intensity ratings did not differ significantly between control and medication nor between medications , we found a significant blood oxygen level-dependent signal increase in the trigeminal nuclei and the thalamus after sumatriptan treatment compared with placebo or ASA .
RESULTS	In addition , we specifically looked for the pharmacologic modulation of functional coupling between trigeminal nuclei and higher brain areas , i.e. , trigemino-cortical pathways , and found a strong coupling during the saline condition , which was altered by sumatriptan but not after ASA administration .
CONCLUSIONS	These data suggest that a specific functional inhibition of trigemino-cortical projections is one of the reasons that triptans , unlike pain killers , act highly specifically on headache and migraine but not pain as such .

###25015597
OBJECTIVE	To compare dilutional effect of distilled water with saline solution as an irrigation fluid in percutaneous nephrolithotomy ( PCNL ) .
METHODS	Three hundred twenty eight adult patients ( 191 men , 137 women ) who were candidates for PCNL were randomly assigned into two groups ( distilled water , n = 158 , group 1 ; saline solution , n = 162 , group 2 ) .
METHODS	Stone size , operation time , irrigation fluid volume , blood hemoglobin level , urea nitrogen , creatinine , sodium and potassium levels were checked before and at 6 and 12 hours after operation .
RESULTS	The mean age of the patients was 37.8 years , and the mean stone diameter was 31.5 mm .
RESULTS	There was no clinical case of transurethral resection ( TUR ) syndrome .
RESULTS	Serum sodium depletion was significantly more in group 1 than group 2 ( P < .0001 ) .
RESULTS	Group 1 had significant decreased post-operative serum sodium levels ( P < .0003 ) .
RESULTS	Similarly in group 2 , postoperative serum sodium levels were significantly lower than the preoperative concentration ( P < .01 ) , but it was not the same 6 hours after the operation ( P = .23 ) .
RESULTS	Serum sodium concentrations remained within normal limits in all cases , without causing clinical signs and symptoms of hyponatremia .
CONCLUSIONS	We found that distilled water is safe irrigation fluid for PCNL in adults .
CONCLUSIONS	In addition , it is more available and cost effective .

###24826396
OBJECTIVE	To determine whether field photodynamic therapy ( PDT ) of actinic keratoses using a novel preparation of 5-aminolevulonic acid ( novel ALA ) results in fewer subsequent invasive skin cancers developing on the face of individuals with previous facial cutaneous malignancy in a prospective randomized controlled trial .
METHODS	Intervention patients received two treatments of novel ALA 2 weeks apart .
METHODS	Controls were observed .
METHODS	Patients were followed up with biopsy of any suspicious lesions for 3 years .
RESULTS	The trial was suspended early because of problems with trial governance and the reporting of severe adverse events .
RESULTS	Sixty-four patients who were recruited at that time at one center were monitored .
RESULTS	Their average age was 71 , and 57 % were male .
RESULTS	Patients were randomized to intervention ( n = 34 ) or observation ( n = 29 ) .
RESULTS	Over the subsequent 3 years , 13 intervention patients ( 38 % ) developed 30 new cutaneous malignancies in the field treated , and 11 control patients ( 38 % ) developed 22 new malignancies .
RESULTS	Some intervention patients experienced prolonged adverse events , including permanent scarring .
CONCLUSIONS	Novel ALA made no difference in the likelihood of new malignancies developing .
CONCLUSIONS	The risks without benefit of this novel ALA are troubling .
CONCLUSIONS	Lack of efficacy and safety of novel ALA can not be extrapolated to other PDT products .

###24553557
BACKGROUND	Nonmedical use of prescription opioids ( NM-POs ) has reached epidemic proportions in the United States .
BACKGROUND	Unintentional overdose deaths involving prescription opioids have quadrupled since 1999 .
BACKGROUND	Herein , we examine NM-POs and their associated risk factors among two cohorts of trauma patients with at-risk drinking .
METHODS	This secondary analysis examines NM-PO from two separate randomized trials that delivered brief alcohol interventions to patients in urban Level I trauma centers .
METHODS	In the first study , data were collected from 1,493 injured patients at a single trauma center , and in the second study , data were collected from 596 injured patients at two trauma centers .
METHODS	All participants were considered at-risk drinkers because they were admitted for an alcohol related injury as indicated by a positive blood alcohol concentration and/or self-reported heavy drinking .
RESULTS	In Study 1 , NM-PO nearly doubled from 5.2 % before admission to 9.8 % at 6 months after discharge .
RESULTS	At 12 months after discharge , those who reported NM-PO ( odds ratio [ OR ] , 2.31 ; 95 % confidence interval [ CI ] , 1.28-4 .15 ) and drug use ( OR , 2.62 , 95 % CI , 1.70-4 .04 ) before admission had the highest odds for postdischarge NM-PO .
RESULTS	In Study 2 , NM-PO increased from 5.2 % before admission to 6.8 % at 12 months after discharge .
RESULTS	At 12 months after discharge , those who reported NM-PO ( OR , 2.71 ; 95 % CI , 1.10-6 .66 ) or drug use ( OR , 4.05 ; 95 % CI , 2.00-8 .21 ) before admission had the highest odds for postdischarge NM-PO .
CONCLUSIONS	The results suggest that there is an increased risk of postdischarge NM-PO among injured patients with at-risk drinking , particularly among those with a recent history of drug use or NM-PO .
CONCLUSIONS	Cautious , evidence-based opioid prescribing may reduce exposure to prescription opioids in high-risk patients , risk of subsequent misuse , and possible diversion .
METHODS	Prognostic/epidemiologic study , level II .

###25542821
OBJECTIVE	To investigate the efficacy and safety of repeated 12-week courses of 5 or 10 mg daily of ulipristal acetate for intermittent treatment of symptomatic uterine fibroids .
METHODS	Double-blind , randomized administration of two 12-week courses of ulipristal acetate .
METHODS	Gynecology centers .
METHODS	A total of 451 patients with symptomatic uterine fibroid ( s ) and heavy bleeding .
METHODS	Two repeated 12-week treatment courses of daily 5 or 10 mg of ulipristal acetate .
METHODS	Amenorrhea , controlled bleeding , fibroid volume , quality of life ( QoL ) , pain .
RESULTS	In the 5 - and 10-mg treatment groups ( 62 % and 73 % of patients , respectively ) achieved amenorrhea during both treatment courses .
RESULTS	Proportions of patients achieving controlled bleeding during two treatment courses were > 80 % .
RESULTS	Menstruation resumed after each treatment course and was diminished compared with baseline .
RESULTS	After the second treatment course , median reductions from baseline in fibroid volume were 54 % and 58 % for the patients receiving 5 and 10 mg of ulipristal acetate , respectively .
RESULTS	Pain and QoL improved in both groups .
RESULTS	Ulipristal acetate was well tolerated with less than 5 % of patients discontinuing treatment due to adverse events .
CONCLUSIONS	Repeated 12-week courses of daily oral ulipristal acetate ( 5 and 10 mg ) effectively control bleeding and pain , reduce fibroid volume , and restore QoL in patients with symptomatic fibroids .
BACKGROUND	NCT01629563 ( PEARL IV ) .

###25445335
OBJECTIVE	The aim of this study is to assess the effectiveness of a very brief structured counseling for tobacco cessation in dentistry clinics .
METHODS	A cluster randomized trial was conducted in Sweden in 2012-2013 .
METHODS	Twenty-seven dentistry clinics in two Swedish counties were randomized to provide either a structured brief advice based on the 5 A 's model or usual care .
METHODS	Participants were 467 patients currently using tobacco daily ( 225 in the intervention group and 242 in usual care ) , of which 97 % were retained at follow-up , six months after enrolment .
METHODS	Study outcomes were : 7-day abstinence ( primary outcome ) ; 3-month sustained abstinence ; 50 % reduction of the amount tobacco used ; quit attempts lasting at least 24h .
RESULTS	Compared to usual care , brief counseling was not associated to statistically significant increase in the proportion abstinent from tobacco use after 6months .
RESULTS	However , there was a statistically significant association with reduction of tobacco consumption ( OR = 2.07 95 % CI 1.28-3 .35 ) .
RESULTS	Changes in the expected direction for all outcomes were more frequent in the intervention than in the usual care group , and larger among exclusive snus users than among smokers .
CONCLUSIONS	Very brief and structured counseling in dentistry may achieve positive behavioral modifications among tobacco users , with significant reduction of tobacco consumption , particularly among smokeless tobacco users .

###25595417
OBJECTIVE	To study whether high-dose versus usual-dose statin treatment reduces the incidence of peripheral artery disease ( PAD ) and what is the effect of high-dose statin treatment on cardiovascular disease ( CVD ) outcome in patients with PAD .
RESULTS	In the Incremental Decrease in End Points Through Aggressive Lipid Lowering trial , 8888 post-myocardial infarction patients were randomised to high-dose or usual-dose statin therapy ( atorvastatin 80mg/day vs simvastatin 20-40mg / day ) .
RESULTS	We investigated the effect of high-dose versus usual-dose statins on the pre-specified outcome PAD incidence , and additionally performed a posthoc analysis of the efficacy of high-dose statins in reducing CVD risk among patients with PAD .
RESULTS	During a median follow-up of 4.8 years , 94 patients ( 2.2 % ) receiving atorvastatin and 135 patients ( 3.2 % ) receiving simvastatin developed PAD ( HR = 0.70 , 95 % CI 0.53 to 0.91 ; p = 0.007 ) .
RESULTS	The risk of major coronary events was almost twofold higher in patients with PAD at baseline , but was no longer significant after adjusting for the adverse cardiovascular risk profile .
RESULTS	In PAD patients , major coronary events occurred in fewer patients in the atorvastatin group ( 14.4 % ) than in the simvastatin group ( 20.1 % ) , but the difference did not reach statistical significance .
RESULTS	( HR = 0.68 , 95 % CI 0.41 to 1.11 ; p = 0.13 ) .
RESULTS	Atorvastatin treatment significantly reduced overall cardiovascular ( p = 0.046 ) and coronary events ( p = 0.004 ) , and coronary revascularisation ( p = 0.007 ) in these patients .
CONCLUSIONS	High-dose statin therapy with atorvastatin significantly reduced the incidence of PAD compared with usual-dose statin therapy with simvastatin .
CONCLUSIONS	Patients with a history of PAD at baseline were at higher risk of future coronary events and this risk was reduced by high-dose atorvastatin treatment .
BACKGROUND	NCT00159835 ( URL : http://clinicaltrials.gov/show/NCT00159835 ) .

###25740700
OBJECTIVE	To evaluate the effect of tube current limitation on contrast enhancement , image quality , and radiation dose in whole-body 64-detector CT with a high heat-capacity X-ray tube and automated tube current modulation .
METHODS	One hundred eighteen patients were randomized into three whole-body CT protocols : tube current limitation at 210 mA , 450 mA , and no limitation .
METHODS	Signal-to-noise ratio ( SNR ) , dose-length product ( DLP ) , estimated effective dose ( ED ) , and image quality were assessed .
RESULTS	Mean SNR of aorta was comparable among protocols , but that of liver was somewhat lower in 210-mA than in 450-mA and no-limitation protocols ( p < 0.05 ) .
RESULTS	Mean DLP with 210-mA ( 533.8 mGy cm ) was reduced by 31 % from that with 450-mA ( 768.4 mGy cm ) and by 38 % from that with no-limitation protocol ( 861.3 mGy cm ) , respectively .
RESULTS	Image quality was slightly degraded ( p < 0.017 ) with 210 mA relative to the others in thorax and pelvis , but no difference was found in diagnostic acceptability .
CONCLUSIONS	For whole-body CT using multidetector CT mounted with a high heat-capacity X-ray tube , an appropriate tube current limitation setting may help reduce excessive radiation dose without significant compromise in diagnostic acceptability .

###25623564
OBJECTIVE	To compare the efficacy and safety of long-term treatment ( 48 weeks ) with tiotropium bromide ( 5 g ) via Respimat ( ) with placebo in patients with chronic obstructive pulmonary disease ( COPD ) .
METHODS	A total of 338 patients were randomized in this double-blind , placebo controlled , parallel study .
METHODS	All patients received either tiotropium bromide or placebo .
METHODS	Tiotropium bromide solution 5 g ( 22.5 g/puff ) or matching placebo was delivered via Respimat ( ) at a dosage of once daily for 48 weeks .
METHODS	Co-primary endpoints were trough forced expiratory volume in one second ( FEV ( 1 ) ) and the time to first exacerbation .
RESULTS	Statistically significant improvements of both trough FEV ( 1 ) and trough forced vital capacity ( FVC ) in the tiotropium group were achieved at weeks 4 , 24 , and 48 compared with those in the placebo group ( P < 0.000 1 ) .
RESULTS	Tiotropium treatment delayed the time to first exacerbation .
RESULTS	The time was 157 days in the tiotropium group and 85 days in the placebo group .
RESULTS	A statistically significant difference ( P = 0.002 7 ) in favor of tiotropium was also observed .
RESULTS	The total numbers of exacerbation during treatment were 90 and 128 in the tiotropium and placebo groups , respectively .
RESULTS	The Poisson regression analysis gave a mean exacerbation rate per patient year exposure of 0.67 in the tiotropium group compared to 0.98 in the placebo group with a rate ratio of 0.69 ( 95 % CI 0.50-0 .93 , P = 0.016 4 ) .
RESULTS	A much larger improvement from baseline in St. George 's respiratory questionnaire ( SGRQ ) total score was observed for the tiotropium group than in the placebo group ( P = 0.036 7 ) , SGRQ symptom and activity scores of patients in the tiotropium group were also superior to those of patients receiving placebo .
RESULTS	The drugs-related adverse events in the tiotropium and placebo groups were 12 cases and 11 cases , respectively .
CONCLUSIONS	Tiotropium significantly improved lung function and quality of life , delayed the time to first exacerbation , reduced the number of exacerbation .
CONCLUSIONS	Overall , tiotropium was well tolerated .

###25514875
BACKGROUND	According to the International Association for the Study of Pain ( IASP ) , the term temporomandibular disorder ( TMD ) regards a subgroup of orofacial pain , the symptoms of which include pain or discomfort in the temporomandibular joint , ears , masticatory muscles and neck on one or both sides , as well as joint sounds , limited mandibular movements or mandibular deviation and difficulties chewing .
BACKGROUND	Phototherapy , such as low-level laser therapy ( LLLT ) and light-emitting diode ( LED ) therapy , is one of the resources used to treatment muscle pain .
BACKGROUND	Thus , there is a need to investigate therapeutic resources that combine different wavelengths as well as different light sources ( LLLT and LED ) in the same apparatus .
BACKGROUND	The aim of the proposed study is to evaluate the effects of four different doses of phototherapy on pain , activity of the masticatory muscles ( masseter and bilateral anterior temporal ) and joint mobility in individuals with temporomandibular disorder .
BACKGROUND	A further aim is to determine the cumulative effect 24 and 48 hours after a single session .
METHODS	A placebo-controlled , double-blind , randomized , clinical trial will be carried out involving 72 women between 18 and 40 years of age with a diagnosis of myogenous TMD .
METHODS	The participants will then be randomly allocated to four groups totaling 18 individuals per group .
METHODS	Three groups will be submitted to a single session of phototherapy with different light sources , and one group will receive placebo therapy : Group A ( 2.62 Joules ) ; Group B ( 5.24 Joules ) ; Group C ( 7.86 Joules ) ; and Group D ( 0 Joules ) .
METHODS	The following assessment tools will be administered on four separate occasions ( baseline and immediately after , 24 h after and 48 h after phototherapy ) .
METHODS	Pain intensity will be assessed using the visual analog scale for pain , while pain thresholds will be determined using algometer , and electromyographic ( EMG ) analysis on the masseter and anterior temporal muscles .
CONCLUSIONS	The study will contribute to the practice of the evidence-based use of phototherapy in individuals with a myogenous TMD .
CONCLUSIONS	Data will be published after the study is completed .
BACKGROUND	This study is registered with the Brazilian Registry of Clinical Trials , NCT02018770 , date of registration : 7 December 2013 .

###24383370
OBJECTIVE	Data relating to the impact of body mass index ( BMI ) on outcomes after isolated aortic valve replacement ( AVR ) are scarce and controversial .
OBJECTIVE	The study aim was to investigate the predictive value of BMI for early and late mortality after isolated AVR .
METHODS	Data obtained from patients who underwent isolated AVR between January 1998 and December 2010 at the authors ' institution were analyzed retrospectively .
METHODS	Patients were allocated to five groups according to the preoperative BMI : underweight ( BMI < 20 kg/m2 ) ; normal weight ( BMI 20.0-24 .9 kg/m2 ) ; overweight ( BMI 25.0-29 .9 kg/m2 ) ; obese ( BMI 30.0-34 .9 kg/m2 ) ; and morbidly obese ( BMI > 34.9 kg/m2 ) .
METHODS	Logistic and Cox regression analyses were performed to identify the independent predictors of early and late mortality , respectively .
RESULTS	After excluding 20 patients who were lost to follow up , and 30 patients with missing preoperative BMI data , a total of 1,758 patients was included in the analysis .
RESULTS	The mean follow up was 5.6 + / - 3.5 years ( range : 0-13 .4 years ) , and the mean BMI 26.8 + / - 4.3 kg/m2 ( range : 17-52 kg/m2 ) .
RESULTS	Multivariate logistic regression analyses showed no association between early mortality and the BMI groups .
RESULTS	Multivariate Cox regression analyses showed ` underweight ' to be an independent predictor for late mortality ( hazard ratio 2.89 ; 95 % confidence interval 1.63-5 .13 , p < 0.0001 ) .
CONCLUSIONS	` Underweight ' is an independent predictor for late mortality after AVR surgery .
CONCLUSIONS	Morbid obesity did not prove to be predictive of a worse late survival .

###24287166
BACKGROUND	Patients with mild to moderate obstructive sleep apnoea ( OSA ) commonly suffer excessive daytime sleepiness .
BACKGROUND	Continuous positive airway pressure ( CPAP ) has limited effectiveness in reducing sleepiness in milder OSA .
BACKGROUND	Modafinil is a wake-promoting drug licensed to treat residual sleepiness in CPAP-treated OSA .
BACKGROUND	We hypothesised that modafinil may effectively treat sleepiness in untreated mild to moderate OSA .
METHODS	Untreated sleepy men with mild to moderate OSA ( age 18-70 , apnoea-hypopnoea index ( AHI ) 5-30 / h , Epworth Sleepiness Scale ( ESS ) 10 ) were randomised to receive 200 mg modafinil or matching placebo daily for 2 weeks before crossing over to the alternative treatment after a minimum 2-week washout .
METHODS	Mixed model analysis of variance was used to compare the changes on modafinil to placebo while classifying all randomised patients as random factors .
RESULTS	32 patients were randomised ( mean ( SD ) AHI 13 ( 6.4 ) / h , age 47 ( 10.7 ) years , ESS 13.6 ( 3.3 ) , body mass index 28.2 ( 3.6 ) kg/m ( 2 ) ) , 29 of whom ( 91 % ) completed the trial .
RESULTS	The primary outcome ( ESS ) improved more on modafinil than placebo ( 3.6 points , 95 % CI 1.3 to 5.8 , p = 0.003 ) and the secondary outcome ( 40-min driving simulator performance ) also improved more on modafinil than placebo ( steering deviation 4.7 cm , 95 % CI 0.8 to 8.5 , p = 0.018 ) .
RESULTS	Psychomotor Vigilance Task reciprocal reaction time improved significantly over placebo ( 0.15 ( 1/ms ) , 95 % CI 0.03 to 0.27 , p = 0.016 ) .
RESULTS	Improvements on the Functional Outcomes of Sleep Questionnaire were not significant ( 5.3 points over placebo , 95 % CI -1 to 11.6 , p = 0.093 ) .
CONCLUSIONS	Modafinil significantly improved subjective sleepiness in patients with untreated mild to moderate OSA .
CONCLUSIONS	The size of this effect is clinically relevant at 3-4 ESS points of improvement compared with only 1-2 points in CPAP clinical trials .
CONCLUSIONS	Driving simulator performance and reaction time also improved on modafinil .
BACKGROUND	ACTRN # 12608000128392 .

###25033745
OBJECTIVE	This study investigated the effects of irrigation solutions , administered at either 21 or 37C in percutaneous nephrolithotomy ( PCNL ) , on hypothermia and related postoperative complications such as late emergence and late recovery from anesthesia , shivering , lactic acidosis , and excess bleeding .
METHODS	Sixty patients who were scheduled for PCNL were enrolled in this prospective randomized double-blind study .
METHODS	Irrigation solutions at room temperature were administered to patients in group R ( 30 patients ) , and warmed irrigation solutions were administered to patients in group W ( 30 patients ) .
METHODS	The two groups were compared for core and peripheral body temperature , incidence of hypothermia , duration of emergence from anesthesia , duration of recovery from anesthesia , shivering , lactic acidosis , and hemoglobin levels .
RESULTS	Hypothermia was incident in 19patients ( 63.3 % ) in group W and in 27 patients ( 90 % ) in group R at the end of surgery .
RESULTS	The difference between the initial and the final core body temperature was 0.90.6 C group W and 1.40.7 C in group R ( p = 0.003 ) .
RESULTS	The extubation time was 4.42.2 min in group W and 5.93 min in group R ( p = 0.032 ) .
RESULTS	Shivering was detected in seven patients ( 23.3 % ) in group W and in 15patients ( 50 % ) in group R ( p = 0.032 ) .
RESULTS	The recovery duration was 49.824.6 min in group W and 67.633.9 min in group R ( p = 0.023 ) .
CONCLUSIONS	Administration of irrigation solutions at room temperature in PCNL operations causes the body temperature to decrease significantly , which results in postoperative complications such as late emergence from anesthesia , late recovery from anesthesia , and shivering .

###24703280
BACKGROUND	The aim of this study was to assess the effect of intraoral aging on the setting status of a resin composite and a glass ionomer adhesive , relative to control specimens stored in water .
METHODS	Metallic brackets were bonded with resin composite orthodontic adhesive ( Transbond XT ; 3M Unitek , Monrovia , Calif ) or a glass ionomer cement ( Fuji I ; GC , Tokyo , Japan ) to recently extracted premolars and kept in water for 6 months .
METHODS	The same materials were also bonded to the premolars of orthodontic patients .
METHODS	After 6 months , the teeth were carefully extracted , with the brackets intact on their buccal surfaces .
METHODS	All teeth were embedded in epoxy resin and sectioned buccolingually .
METHODS	Fourier transform infrared microscopy and Raman microscopy were used for the estimation of the degree of cure in the composite and the salt yield in the glass ionomer adhesives .
RESULTS	The control samples of the composite showed significantly lower degrees of cure than did the retrieved specimens ( 52.40 % 3.21 % vs 57.62 % 1.32 % by Fourier transform infrared microscopy , and 61.40 % 2.61 % vs 67.40 % 3.44 % by Raman microscopy ) .
RESULTS	Raman microscopy significantly overestimated the degree of cure and failed to provide reliable information for the salt yield in the glass ionomer cement .
RESULTS	Fourier transform infrared microscopy showed increased , but no statistically significant difference in , aluminum-carboxylate salts in the retrieved specimens .
CONCLUSIONS	Enhanced oxidation of residual carbon-carbon bonds in the composite and slightly increased dissolution of the weaker calcium-salt phase in the glass ionomer cement were the main differences in the intraorally aged specimens in comparison with the specimens stored in water .

###26324049
BACKGROUND	Conflicting evidence exists on the efficacy and safety of bivalirudin administered as part of percutaneous coronary intervention ( PCI ) in patients with an acute coronary syndrome .
METHODS	We randomly assigned 7213 patients with an acute coronary syndrome for whom PCI was anticipated to receive either bivalirudin or unfractionated heparin .
METHODS	Patients in the bivalirudin group were subsequently randomly assigned to receive or not to receive a post-PCI bivalirudin infusion .
METHODS	Primary outcomes for the comparison between bivalirudin and heparin were the occurrence of major adverse cardiovascular events ( a composite of death , myocardial infarction , or stroke ) and net adverse clinical events ( a composite of major bleeding or a major adverse cardiovascular event ) .
METHODS	The primary outcome for the comparison of a post-PCI bivalirudin infusion with no post-PCI infusion was a composite of urgent target-vessel revascularization , definite stent thrombosis , or net adverse clinical events .
RESULTS	The rate of major adverse cardiovascular events was not significantly lower with bivalirudin than with heparin ( 10.3 % and 10.9 % , respectively ; relative risk , 0.94 ; 95 % confidence interval [ CI ] , 0.81 to 1.09 ; P = 0.44 ) , nor was the rate of net adverse clinical events ( 11.2 % and 12.4 % , respectively ; relative risk , 0.89 ; 95 % CI , 0.78 to 1.03 ; P = 0.12 ) .
RESULTS	Post-PCI bivalirudin infusion , as compared with no infusion , did not significantly decrease the rate of urgent target-vessel revascularization , definite stent thrombosis , or net adverse clinical events ( 11.0 % and 11.9 % , respectively ; relative risk , 0.91 ; 95 % CI , 0.74 to 1.11 ; P = 0.34 ) .
CONCLUSIONS	In patients with an acute coronary syndrome , the rates of major adverse cardiovascular events and net adverse clinical events were not significantly lower with bivalirudin than with unfractionated heparin .
CONCLUSIONS	The rate of the composite of urgent target-vessel revascularization , definite stent thrombosis , or net adverse clinical events was not significantly lower with a post-PCI bivalirudin infusion than with no post-PCI infusion .
CONCLUSIONS	( Funded by the Medicines Company and Terumo Medical ; MATRIX ClinicalTrials.gov number , NCT01433627 . )

###24928832
BACKGROUND	Afatinib is an oral , irreversible ErbB family blocker that has shown activity in epidermal growth factor receptor ( EGFR ) - mutated lung cancer .
BACKGROUND	We hypothesized that the agent would have greater antitumor activity compared with cetuximab in recurrent or metastatic ( R/M ) head and neck squamous cell carcinoma ( HNSCC ) patients , whose disease has progressed after platinum-containing therapy .
METHODS	An open-label , randomized , phase II trial was conducted in 43 centers ; 124 patients were randomized ( 1 : 1 ) to either afatinib ( 50 mg/day ) or cetuximab ( 250 mg/m ( 2 ) / week ) until disease progression or intolerable adverse events ( AEs ) ( stage I ) , with optional crossover ( stage II ) .
METHODS	The primary end point was tumor shrinkage before crossover assessed by investigator ( IR ) and independent central review ( ICR ) .
RESULTS	A total of 121 patients were treated ( 61 afatinib , 60 cetuximab ) and 68 crossed over to stage II ( 32 and 36 respectively ) .
RESULTS	In stage I , mean tumor shrinkage by IR/ICR was 10.4 % / 16.6 % with afatinib and 5.4 % / 10.1 % with cetuximab ( P = 0.46 / 0.30 ) .
RESULTS	Objective response rate was 16.1 % / 8.1 % with afatinib and 6.5 % / 9.7 % with cetuximab ( IR/ICR ) .
RESULTS	Comparable disease control rates were observed with afatinib ( 50 % ) and cetuximab ( 56.5 % ) by IR ; similar results were seen by ICR .
RESULTS	Most common grade 3 drug-related AEs ( DRAEs ) were rash/acne ( 18 % versus 8.3 % ) , diarrhea ( 14.8 % versus 0 % ) , and stomatitis/mucositis ( 11.5 % versus 0 % ) with afatinib and cetuximab , respectively .
RESULTS	Patients with DRAEs leading to treatment discontinuation were 23 % with afatinib and 5 % with cetuximab .
RESULTS	In stage II , disease control rate ( IR/ICR ) was 38.9 % / 33.3 % with afatinib and 18.8 % / 18.8 % with cetuximab .
CONCLUSIONS	Afatinib showed antitumor activity comparable to cetuximab in R/M HNSCC in this exploratory phase II trial , although more patients on afatinib discontinued treatment due to AEs .
CONCLUSIONS	Sequential EGFR/ErbB treatment with afatinib and cetuximab provided sustained clinical benefit in patients after crossover , suggesting a lack of cross-resistance .

###24947878
BACKGROUND	Exercise training may improve components of metabolic syndrome and obstructive sleep apnea syndrome ( OSAS ) .
BACKGROUND	The objective of our pilot randomized controlled study was to determine the benefits of a short intensive inpatient individualized exercise training ( IET ) program in sedentary untreated OSAS patients .
METHODS	Twenty-two sedentary patients with moderate to severe OSAS were randomly assigned either to one-month education activity sessions ( n = 11 ; control group ) or to inpatient rehabilitation program ( n = 11 ) , including IET , education activities sessions , and dietary management .
METHODS	Full polysomnography ( PSG ) , OSLER ( Oxford Sleep Resistance test ) , body composition , anthropometric measurements , metabolic syndrome components , and questionnaires were performed at baseline and at study end point .
RESULTS	No changes occurred in the control group in all variables .
RESULTS	Compared to controls , participants randomized to the IET group presented a significant decrease in apnea-hypopnea index ( AHI ) ( 40.619.4 vs. 28.019.3 ; P < 0.001 ) , oxygen desaturation index ( ODI ) , and arousal index , which occurred in conjunction with significant decrease in body mass index ( BMI ) , neck circumference , fat mass , fasting glucose , and diastolic blood pressure .
RESULTS	Increased sleep latency was found in participants in the IET group with altered values at baseline .
CONCLUSIONS	IET reduced OSAS severity with improvement of metabolic syndrome components with concomitant loss in body fat in sedentary adults .
CONCLUSIONS	If confirmed on a larger scale , a comprehensive rehabilitation program could constitute an additional or alternative treatment for moderate to severe OSAS patients .

###24990088
BACKGROUND	The most appropriate means of capturing data from the Neuropsychiatric Inventory ( NPI ) must be understood to optimize use of this instrument in clinical trials .
BACKGROUND	The utility of the composite score ( frequency times severity ) was recently demonstrated in mild and moderate dementia .
BACKGROUND	Determination of frequency compared to composite scores in mild cognitive impairment ( MCI ) warrants investigation .
METHODS	We used the NPI data from a randomized , placebo-controlled , multi-center , 24-week , clinical trial involving 160 patients who were diagnosed with amnestic MCI and had clinically significant neuropsychiatric symptoms ( NPS ) .
METHODS	We calculated standardized changes for both frequency and composite scores .
RESULTS	There were improvements in NPI composite scores in both active drug - and placebo-treated patients , with significant superiority of active drug .
RESULTS	Standardized changes in severity and composite scores tended to be larger than those in the frequency scores , whereas discrimination between treatment groups was similar for all three scores .
CONCLUSIONS	Our findings support the hypothesis that in MCI , as in dementia , the NPI frequency score is not more sensitive to treatment-related change than the composite score .
CONCLUSIONS	As the severity score adds information , the use of the composite score has better performance characteristics .

###24423311
BACKGROUND	Patients with type 2 diabetes mellitus ( T2DM ) have clinically relevant disturbances in the effects of the hormone glucose-dependent insulinotropic polypeptide ( GIP ) .
OBJECTIVE	We aimed to evaluate the importance of the prevailing plasma glucose levels for the effect of GIP on responses of glucagon and insulin and glucose disposal in patients with T2DM .
METHODS	We performed a single center , placebo-controlled , cross-over , experimental study .
METHODS	We studied twelve patients with T2DM ( age : 62 1 years [ mean SEM ] , body mass index : 29 1 kg/m ( 2 ) ; glycosylated hemoglobin A1c : 6.5 0.1 % [ 48 2 mmol/mol ] ) .
METHODS	We infused physiological amounts of GIP ( 2 pmol kg ( -1 ) min ( -1 ) ) or saline .
METHODS	We measured plasma concentrations of glucagon , glucose , insulin , C-peptide , intact GIP , and amounts of glucose needed to maintain glucose clamps .
RESULTS	During fasting glycemia ( plasma glucose 8 mmol/L ) , GIP elicited significant increments in both insulin and glucagon levels , resulting in neutral effects on plasma glucose .
RESULTS	During insulin-induced hypoglycemia ( plasma glucose 3 mmol/L ) , GIP elicited a minor early-phase insulin response and increased glucagon levels during the initial 30 minutes , resulting in less glucose needed to be infused to maintain the clamp ( 29 8 vs 49 12 mg kg ( -1 ) , P < .03 ) .
RESULTS	During hyperglycemia ( 1.5 fasting plasma glucose 12 mmol/L ) , GIP augmented insulin secretion throughout the clamp , with slightly less glucagon suppression compared with saline , resulting in more glucose needed to maintain the clamp during GIP infusions ( 265 21 vs 213 13 mg kg ( -1 ) , P < .001 ) .
CONCLUSIONS	In patients with T2DM , GIP counteracts insulin-induced hypoglycemia , most likely through a predominant glucagonotropic effect .
CONCLUSIONS	In contrast , during hyperglycemia , GIP increases glucose disposal through a predominant effect on insulin release .

###25438609
OBJECTIVE	To determine the effect of fall-related concerns on physical , mental , and social function .
METHODS	Community-based prospective cohort study ( secondary analysis using control group data from a randomized controlled trial ) .
METHODS	Two municipalities in the south of the Netherlands .
METHODS	Community-dwelling older adults ( N = 260 ) .
METHODS	Two groups were created using Modified Falls Efficacy Scale scores ( high and low levels of fall-related concerns ) .
METHODS	Five outcome measures representing physical , mental , and social function were included : activities of daily living ( ADLs ) , symptoms of depression , feelings of anxiety , social participation , and social support interactions .
METHODS	Outcomes were measured at baseline and at 2 , 8 , and 14 months .
METHODS	Data were analyzed using analysis of covariance and mixed-effect regression models for longitudinal data , adjusting for age , sex , living status ( alone or with another person ) , educational level , cognitive status , self-perceived health , and falls history at baseline .
RESULTS	At baseline , significantly more limitations in ADLs and social participation were found for older persons with high levels of fall-related concerns than for those with low levels of concern .
RESULTS	These differences persisted over 14 months of follow-up and were consistent over time .
RESULTS	No significant differences were found for symptoms of depression , feelings of anxiety , or social support interactions , except for feelings of anxiety at 14 months .
CONCLUSIONS	Older persons with higher levels of fall-related concerns reported up to 14 months poorer ADL and social participation for up to 14 months than those with lower levels of fall-related concerns .
CONCLUSIONS	From a clinical point of view , the clear relationship between fall-related concerns and ADL dysfunction and social participation may help to target groups who are at risk of developing adverse consequences of concerns about falls .

###25048381
OBJECTIVE	To determine whether an intensive lifestyle intervention ( ILI ) designed to sustain weight loss and improve physical fitness in overweight or obese persons with type 2 diabetes was associated with bone loss after 4 years of follow-up .
METHODS	This randomized controlled trial of intensive weight loss compared an ILI with a diabetes support and education ( DSE ) group among 1,309 overweight or obese subjects .
METHODS	Bone mineral density was assessed at baseline and after 1 year and 4 years of intervention .
RESULTS	ILI was effective in producing significant weight loss ( 5.3 % vs. 1.8 % in ILI and DSE , respectively ; P < 0.01 ) and increased fitness ( 6.4 % vs. -0.8 % ) at year 4 .
RESULTS	In men , ILI participants had a greater rate of bone loss during the first year ( -1.66 % vs. -0.09 % per year in ILI and DSE , respectively ) .
RESULTS	Differences between groups were diminished by one-half after 4 years ( -0.88 % vs. -0.05 % per year in ILI and DSE , respectively ) but remained significant ( P < 0.01 ) .
RESULTS	The difference in rate of hip bone loss between groups over 4 years was related to increased weight loss in ILI .
RESULTS	Among women , the rate of bone loss did not differ between ILI and DSE after 4 years .
CONCLUSIONS	A 4-year weight loss intervention was significantly associated with a modest increase in bone loss at the hip in men but not in women .

###25002136
BACKGROUND	Epidemiological studies have found a U-shaped relationship between serum phosphorus and cardiovascular disease ( CVD ) .
BACKGROUND	The mechanism ( s ) behind such a relationship are poorly understood .
BACKGROUND	Phosphorus ( P ) is reported to improve insulin sensitivity , which is involved in lipid metabolism , and thus we were interested in determining the impact of phosphorus ingestion on postprandial lipemia , a recognized CVD risk factor .
RESULTS	A within-subject study design was conducted , whereby 8 healthy male subjects received a high fat meal ( 330 Kcal ; 69 % energy from fat ; 35 mg of phosphorus ) with placebo or phosphorus ( 500 mg ) in a random order .
RESULTS	Postprandial blood samples ( ~ 10 ml ) were collected every hour for 6 hours after meal ingestion .
RESULTS	Changes in different parameters were analyzed using a 2-factor repeated-measure ANOVA .
RESULTS	In the phosphorus ( P ) supplemented group , postprandial serum P increased ( p = 0.00 ) , while changes in insulin , non-esterified fatty acids ( NEFA ) and triglyceride ( TG ) were not significantly different than that of placebo .
RESULTS	Concurrently , phosphorus supplementation increased postprandial concentrations of apolipoprotein B48 ( ApoB48 ) ( p < 0.05 ) and decreased that of apolipoprotein B100 ( ApoB100 ) ( p < 0.05 ) .
CONCLUSIONS	Phosphorus supplementation ( 500 mg ) of the meal seems to alter the different components of postprandial lipemia .
CONCLUSIONS	These findings highlight the potential role of phosphorus in CVD .

###24477109
OBJECTIVE	To determine whether extracranial-intracranial ( EC-IC ) bypass can improve cognition over 2 years compared to best medical therapy alone in patients with symptomatic internal carotid artery ( ICA ) occlusion and increased oxygen extraction fraction ( OEF ) on PET .
METHODS	Patients underwent ( 15 ) O PET and were randomized if OEF ratio was > 1.13 on the occluded side .
METHODS	Using blinded baseline and 2-year cognitive assessments , age-adjusted composite z scores were generated from subtests sensitive to right/left hemisphere plus global cognitive functioning .
METHODS	Multiple regression predicted 2-year cognitive change .
RESULTS	Eighty-nine patients were enrolled ; 41 had increased OEF and were randomized .
RESULTS	Two died , 2 were lost to follow-up , and 2 refused 2-year testing .
RESULTS	Of the 35 remaining , 6 had ipsilateral stroke or death , leaving 13 surgical and 16 medical patients .
RESULTS	Controlling for age , education , and depression , there was no difference in 2-year cognitive change between the medical and surgical arms ( 95 % confidence interval -0.5 to 0.5 , p = 0.9 ) .
RESULTS	In post hoc analysis of 26 patients with no stroke in the follow-up period , cognitive improvement was associated with less impaired PET OEF at baseline ( p = 0.045 ) .
CONCLUSIONS	Cognitive improvement following bypass surgery was not superior to medical therapy among patients with recently symptomatic carotid occlusion and increased OEF .
CONCLUSIONS	Among those with no recurrent stroke , less hemodynamic impairment at baseline was associated with greater cognitive gain in both groups .
CONCLUSIONS	Reversing cognitive impairment in hemodynamic failure remains an open challenge .
METHODS	This study provides Class II evidence that for patients with symptomatic ICA occlusion and increased OEF on PET , EC-IC bypass compared to no bypass does not improve cognitive function after 2 years .

###25982590
OBJECTIVE	To evaluate the safety , tolerability , and comparative pharmacokinetics ( PK ) of intravenous and oral carbamazepine .
METHODS	In this phase 1 , open-label study , adult patients with epilepsy on a stable oral carbamazepine dosage ( 400-2 ,000 mg/day ) were converted to intravenous carbamazepine ( administered at 70 % of the oral dosage ) .
METHODS	A 28-day outpatient period preceded an up to 10-day inpatient period and a 30-day follow-up period .
METHODS	Intravenous carbamazepine was administered over 15 or 30 min every 6 h on days 1-7 ; some patients in the 15-min group were eligible to receive four 2 - to 5-min ( rapid ) infusions on day 8 .
METHODS	Patients underwent blood sampling to determine the area under the concentration-time curve ( AUC ) for carbamazepine and metabolite carbamazepine-10 ,11 - epoxide following oral ( day 0 ) and intravenous carbamazepine administration ( days 1 , 7 , and 8 ) .
METHODS	Bioequivalence was evaluated in patients with normal renal function ( creatinine clearance > 80 ml/min ) .
METHODS	Safety assessments were conducted through day 38 .
RESULTS	Ninety-eight patients enrolled and 77 completed the PK component .
RESULTS	The mean daily oral and intravenous carbamazepine dosage for 64 PK-evaluable patients with normal renal function was 962.5 and 675.1 mg ( 70 % of oral dosage ) , respectively .
RESULTS	Steady-state minimum concentration ( C ( min ) ) and overall exposure ( AUC0-24 ) for intravenous carbamazepine infused over 30 , 15 , or 2-5 min were similar to oral carbamazepine .
RESULTS	The 90 % confidence intervals ( CIs ) for the ratios of the adjusted means for AUC0-24 , maximum concentration ( Cmax ) , and C ( min ) were within the 80 % -125 % bioequivalence range for 30-min intravenous infusions versus oral administration , but exceeded the upper limit for Cmax for the 15-min and rapid infusions .
RESULTS	All intravenous carbamazepine infusions were well tolerated .
CONCLUSIONS	Intravenous carbamazepine infusions ( 70 % of oral daily dose ) of 30 - , 15 - , and 2 - to 5-min duration , given every 6 h , maintained patients ' plasma carbamazepine concentrations .
CONCLUSIONS	Intravenous carbamazepine 30-min infusions were bioequivalent to oral carbamazepine in patients with normal renal function ; rapid infusions were well-tolerated in this study .

###24270950
OBJECTIVE	To assess the effectiveness of healthcare team guidance in the implementation of a glycemic control protocol in the non-intensive care unit of a cardiology hospital .
METHODS	This was a randomized clinical trial comparing 9 months of intensive guidance by a healthcare team on a protocol for diabetes care ( Intervention Group , n = 95 ) with 9 months of standard care ( Control Group , n = 87 ) .
METHODS	Clinicaltrials.gov : NCT01154413 .
RESULTS	The mean age of the patients was 61.710 years , and the mean glycated hemoglobin level was 7123 mmol/mol ( 8.72.1 % ) .
RESULTS	The mean capillary glycemia during hospitalization was similar between the groups ( 9.82.9 and 9.12.4 mmol/l for the Intervention Group and Control Group , respectively , p = 0.078 ) .
RESULTS	The number of hypoglycemic episodes ( p = 0.77 ) , hyperglycemic episodes ( 47 vs. 50 in the Intervention Group and Control Group , p = 0.35 , respectively ) , and the length of stay in the hospital were similar between the groups ( p = 0.64 ) .
RESULTS	The amount of regular insulin administered was 0 ( 0-10 ) IU in the Intervention Group and 28 ( 7-56 ) IU in the Control Group ( p < 0.001 ) , and the amount of NPH insulin administered was similar between the groups ( p = 0.16 ) .
CONCLUSIONS	While guidance on a glycemic control protocol given by a healthcare team resulted in a modification of the therapeutic strategy , no changes in glycemic control , frequency of episodes of hypoglycemia and hyperglycemia , or hospitalization duration were observed .

###24886409
BACKGROUND	Dietary carbohydrates may affect metabolic and physiologic parameters .
BACKGROUND	The present study evaluated whether a combination of two dietary fibers , oligofructose ( OFS ) and pectin ( P ) , altered satiety and glycemic parameters .
BACKGROUND	The primary objective of this study was to determine whether dietary supplementation for 3weeks with OFS+P would produce a greater reduction in energy intake of an ad libitum test meal compared to control .
METHODS	This was a single center , randomized , double-blind , placebo-controlled , parallel group study in overweight and obese , otherwise healthy , subjects ( N = 96 ) .
METHODS	There were two OFS+P treatment groups : high-dose ( 30g/d ) , low-dose ( 15g/d ) , and a control group ( maltodextrin 15g/d ) .
METHODS	Energy intake , appetite measures based on Satiety Labeled Intensity Magnitude ( SLIM ) scale , fasting and post-prandial glucose , and insulin levels and body weight were measured at baseline and at the end of 3weeks .
METHODS	Adverse events and gastrointestinal tolerability of the treatments were also assessed .
RESULTS	An analysis of covariance ( ANCOVA ) performed on the primary endpoint change from baseline in energy intake , showed no statistically significant difference in energy intake among the three treatment groups ( p = 0.5387 ) .
RESULTS	The LS mean changes ( SE ) in energy intake from baseline to week 3 were -58.3 ( 42.4 ) kilocalories ( kcal ) for the high dose group , -74.2 ( 43.6 ) kcal for the low dose group , and -9.0 ( 42.9 ) kcal for the control group .
RESULTS	For the pairwise comparisons of OFS+P doses and control , confidence intervals were constructed around the difference in LS mean changes .
RESULTS	All study products were generally well tolerated .
CONCLUSIONS	There was a directional benefit in ad libitum energy intake for both OFS+P doses compared to control , with a greater reduction in kilocalories in the low dose comparison , but the reductions were not significant .
CONCLUSIONS	Further studies are warranted .
BACKGROUND	GSK Clinical Study Register # W7781293 .

###25066019
OBJECTIVE	To examine protocol fidelity among teachers involved in a six-month cluster-randomized physical activity ( PA ) intervention .
METHODS	In 2011 , preschools in Springfield , MA were randomized to short bouts of structured PA ( SBS-PA , n = 5 ) or unstructured playtime ( UPA , n = 5 ) .
METHODS	SBS-PA provided structured PA in the classroom during the first 10 min of gross-motor playtime followed by 20 min of unstructured playtime .
METHODS	UPA consisted of 30 min of unstructured playtime .
METHODS	All teachers ( SBS-PA and UPA ) received a written study protocol and 1.5 h of training .
METHODS	SBS-PA also received videos to use to lead structured PA and 1.5 additional hours of training .
METHODS	Study fidelity and process evaluation were assessed twice weekly via semi-structured questionnaire .
RESULTS	Only 56.6 % of SBS-PA and 75.2 % of UPA free playtimes lasted for 30 min ; 86.3 % of SBS-PA teachers implemented structured PA during the first 10 min of gross-motor playtime but only 67.2 % delivered the intervention as instructed .
RESULTS	Only 68.5 % of SBS-PA teachers implemented the 20-minute unstructured playtime .
RESULTS	SBS-PA teachers reported that time limitations was a major barrier in implementing the designed intervention .
RESULTS	Pre-post changes in PA did not differ between groups .
CONCLUSIONS	Limited fidelity to intervention protocol likely impacted study findings .
CONCLUSIONS	Future studies should focus on strategies to improve adherence among intervention leaders .

###25987694
OBJECTIVE	Advanced pancreatic cancer ( APC ) , in addition to its high mortality , accounts for the highest rates of venous thromboembolic events ( VTEs ) .
OBJECTIVE	Enoxaparin , a low-molecular weight heparin , is effective in prevention and treatment of VTEs .
OBJECTIVE	Some small studies have indicated that this benefit might extend to patients with cancer .
METHODS	Patients with histologically proven APC were randomly assigned to ambulant first-line chemotherapy and prophylactic use of enoxaparin or chemotherapy alone to investigate the probable reduction in symptomatic VTEs and the impact on survival .
RESULTS	A total of 312 patients were recruited as one of the protocol end points was reached .
RESULTS	Within the first 3 months , the numbers of symptomatic VTEs were as follows : 15 of 152 patients in the observation group and two of 160 patients in the enoxaparin group ( hazard ratio [ HR ] , 0.12 ; 95 % CI , 0.03 to 0.52 ; ( 2 ) P = .001 ) .
RESULTS	The numbers of major bleeding events were as follows : five of 152 patients in the observation arm and seven of 160 patients in the enoxaparin arm ( HR , 1.4 ; 95 % CI , 0.35 to 3.72 ; ( 2 ) P = 1.0 ) .
RESULTS	Overall cumulative incidence rates of symptomatic VTEs were 15.1 % ( observation ) and 6.4 % ( enoxaparin ; HR , 0.40 ; 95 % CI , 0.19 to 0.83 ; P = .01 ) .
RESULTS	Progression-free ( HR , 1.06 ; 95 % CI , 0.84 to 1.32 ; P = .64 ) and overall survival ( HR , 1.01 ; 95 % CI , 0.87 to 1.38 ; P = .44 ) did not differ between groups .
CONCLUSIONS	This study demonstrates the high efficacy and feasibility of primary pharmacologic prevention of symptomatic VTEs in outpatients with APC .
CONCLUSIONS	Treatment efficacy was not affected by simultaneous treatment with enoxaparin in this trial setting .

###25022156
BACKGROUND	As spaceflight compromises skeletal muscle oxidative and aerobic work capacity , this study assessed the efficacy of resistance exercise ( RE ) to counteract muscle metabolic perturbations induced by 5 wk unilateral lower limb unloading ( UL ) .
METHODS	There were 21 men and women ( 30-56 yr ) who were randomly assigned to either UL with ( Group , Grp ; UL+RE ; N = 10 ) or without ( Grp UL ; N = 11 ) concurrent RE .
METHODS	Iso-inertial RE comprised four sets of seven maximal coupled concentric-eccentric knee extensions executed 2-3 times per week .
METHODS	Percutaneous biopsies were obtained from m. vastus lateralis before and after either intervention .
METHODS	Levels of mRNA expression of factors regulating skeletal muscle oxidative capacity i.e. , peroxisome proliferator-activated receptor gamma coactivator-1 ( PGC-1alpha ) and vascular endothelial growth factor ( VEGF ) , and glycolytic capacity , i.e. , phosphofructokinase ( PFK ) , glycogen phosphorylase and synthase , hexokinase , and phosphorylase kinase alpha1 , were subsequently analyzed .
RESULTS	Grp UL showed decreased ( 36 % ) PGC-1alpha expression , increased ( 1.5-fold ) PFK expression , and a trend toward decreased VEGF post-intervention .
RESULTS	Grp UL+RE showed no changes .
CONCLUSIONS	These results suggest that 5 wk unloading reduces skeletal muscle oxidative capacity and increases glycolytic enzyme activity .
CONCLUSIONS	More importantly , only 12 bouts of high-force , low-volume resistance exercise attenuated these responses .
CONCLUSIONS	Thus , the current resistance exercise paradigm emphasizing eccentric overload effectively counteracts unwarranted metabolic alterations induced by 5 wk unloading and may , therefore , aid in maintaining skeletal muscle integrity and endurance , and hence astronaut health and fitness during spaceflight .

###24454970
BACKGROUND	Anti-leishmanial drug regimens that include a single dose AmBisome could be suitable for eastern African patients with symptomatic visceral leishmaniasis ( VL ) but the appropriate single dose is unknown .
METHODS	A multi-centre , open-label , non-inferiority , randomized controlled trial with an adaptive design , was conducted to compare the efficacy and safety of a single dose and multiple doses of AmBisome for the treatment of VL in eastern Africa .
METHODS	The primary efficacy endpoint was definitive cure ( DC ) at 6 months .
METHODS	Symptomatic patients with parasitologically-confirmed , non-severe VL , received a single dose of AmBisome 7.5 mg/kg body weight or multiple doses , 7 times 3 mg/kg on days 1-5 , 14 , and 21 .
METHODS	If interim analyses , evaluated 30 days after the start of treatment following 40 or 80 patients , showed the single dose gave significantly poorer parasite clearance than multiple doses at the 5 % significance level , the single dose was increased by 25 mg/kg .
METHODS	In a sub-set of patients , parasite clearance was measured by quantitative reverse transcriptase ( qRT ) PCR .
RESULTS	The trial was terminated after the third interim analysis because of low efficacy of both regimens .
RESULTS	Based on the intention-to-treat population , DC was 85 % ( 95 % CI 73-93 % ) , 40 % ( 95 % CI 19-64 % ) , and 58 % ( 95 % CI 41-73 % ) in patients treated with multiple doses ( n = 63 ) , and single doses of 75 ( n = 21 ) or 10 mg/kg ( n = 40 ) , respectively .
RESULTS	qRT-PCR suggested superior parasite clearance with multiple doses as early as day 3 .
RESULTS	Safety data accorded with the drug label .
CONCLUSIONS	The tested AmBisome regimens would not be suitable for VL treatment across eastern Africa .
CONCLUSIONS	An optimal single dose regimen was not identified .
BACKGROUND	www.clinicaltrials.govNCT00832208 .

###24534386
BACKGROUND	It is not clear whether Modic changes ( MC ) is associated with low back pain ( LBP ) outcome .
OBJECTIVE	To study associations between baseline degenerative manifestations and outcome in sick-listed LBP patients .
METHODS	Prospective nested cohort study based on a randomized controlled trial .
METHODS	Out of 325 sick-listed LBP patients , 141 were consecutively examined by magnetic resonance imaging ( MRI ) and included and 140 completed the study .
METHODS	Degenerative manifestations of the lumbar spine were quantified ; associations were studied in relation to the three primary outcomes : change of back + leg pain , change of function as measured by Roland-Morris questionnaire , and 1-year unsuccessful return to work ( U-RTW ) .
METHODS	By using a previously validated MRI protocol , a specialist in radiology , who had no access to clinical data , described the images .
METHODS	Associations were studied by linear and logistic regression with adjustment for previously identified prognostic factors for 1-year pain and function and for U-RTW .
RESULTS	Clinically , 43 % of the patients had radiculopathy .
RESULTS	Degenerative changes were prevalent with altered disc contours in 84 % , high-intensity zones in 70 % , and nerve root touch or impingement in 63 % of the patients .
RESULTS	MC was identified in 60 % of the patients , 18 % with Type 1 changes and 42 % with Type 2 changes , Type 1 including both Type 1 and Type 1 in combination with Type 2 .
RESULTS	Patients with Type 1 changes reported more back pain and did not improve in pain or disability .
RESULTS	They increased to include 30 % of the patients with U-RTW at 1 year .
RESULTS	Patients with Type 2 changes did not differ significantly from patients without MC but differed significantly from patients with Type 1 changes in all three outcomes .
RESULTS	Other degenerative manifestations were not significantly associated with any of the three outcomes .
CONCLUSIONS	The only degenerative manifestation negatively associated with outcome was Type 1 MC that affected 18 % of the cohort at baseline and implied an increased risk for no improvement in pain and function and for U-RTW , even after adjustment for other prognostic factors .

###25517194
BACKGROUND	Knowledge of the excess hospital costs and prolonged length of stay attributable to perioperative respiratory event ( PRE ) in pediatric anesthesia is useful for hospital planning .
BACKGROUND	In this study , we compared costs ( excess hospital costs and indirect costs ) and length of hospital stay between children who had PRE and did not have PRE for noncardiac surgery at a tertiary care hospital in southern Thailand .
METHODS	A prospective matched cohort study was conducted in children aged < 15 years who underwent general anesthesia between November 2012 and December 2013 at Songklanagarind Hospital .
METHODS	PRE children were matched with no PRE children ( 1:1 ) using a random selection procedure on outpatients/inpatients , type of surgery , surgical charge ( baht ) , ASA physical status , age difference < 9 years , and difference in time of surgery < 6 months .
METHODS	Primary end points were excess hospital costs and number of days hospitalized after surgery .
METHODS	Number of days hospitalized after surgery , excess hospital costs and indirect costs regarding transportation , and income loss of parents between groups were compared using Wilcoxon signed rank test .
METHODS	Any hospital stay after surgery between groups was compared using McNemar test .
METHODS	A hurdle model was used to predict any hospital stay and number of days hospitalized after surgery .
METHODS	Multiple mixed-effects linear regression was used to identify predictors of adjusted excess hospital costs and indirect costs .
RESULTS	A total 430 children were included ( 215 matched pairs ) .
RESULTS	More PRE children required hospital stay after surgery ( 81 % vs 72 % , P = 0.004 ) , and PRE children had a longer number of days hospitalized after surgery ( median [ interquartile ranges ] : 1 [ 1-3 .5 ] vs 1 [ 0-2 ] ; P < 0.001 ) and incurred higher excess costs ( P < 0.001 ) but not indirect costs ( P = 0.23 ) .
RESULTS	In multivariate analysis , PRE was a significant predictor for hospital stay after surgery ( odds ratio , 2.56 ; 95 % confidence interval , 1.23-5 .31 ) , longer hospitalization ( count ratio , 2.10 [ 1.31-3 .35 ] ) , higher excess costs ( cost ratio , 1.30 [ 1.12-1 .53 ] ) , and indirect cost ( cost ratio , 1.58 [ 1.20-2 .08 ] ) after adjusting for patient and anesthesia characteristics .
RESULTS	Universal coverage ( 74 % ) was associated with 35 % and 64 % higher excess cost compared with the Comptroller General 's Department ( 17 % ) and self-pay ( 7 % ) , respectively ( P = 0.003 ) .
CONCLUSIONS	The effects of PRE in pediatric anesthesia were hospital stay after surgery , 2 times longer hospitalization , 30 % higher excess hospital costs , and 58 % higher indirect cost among outpatients .
CONCLUSIONS	Hospital policy to efficiently manage hospital beds and compensatory budget should be developed .

###24994839
BACKGROUND	The level of evidence regarding the association between red and processed meat intakes and breast cancer risk is still low , due to insufficient prospective studies .
BACKGROUND	Moreover , mechanistic data suggest that some antioxidants may modulate this relationship but epidemiological evidence is lacking .
BACKGROUND	Our objectives were to investigate relationships between red and processed meat intakes and breast cancer risk , and to study whether an antioxidant supplementation modulates these associations , which , to our knowledge , has never been investigated before .
METHODS	The SU.VI.MAX study was a randomized , double-blind , placebo-controlled trial in which participants received a combination of low-dose antioxidants or a placebo from 1994 to 2002 .
METHODS	This observational prospective analysis included 4684 women among whom 190 developed a first incident breast cancer between 1994 and 2007 [ mean ( range ) follow-up = 11.3 ( 0-13 ) years ] .
METHODS	Baseline dietary data were assessed by repeated dietary records in 1994-1995 .
METHODS	Associations between quartiles of red and processed meat intakes and breast cancer risk were characterized by multivariate Cox proportional hazards models .
RESULTS	Breast cancer risk was directly associated with processed meat intake [ hazard ratio ( HR ) Q4vsQ1 = 1.45 ( 0.92-2 .27 ) , Ptrend = 0.03 ] and this association was stronger when excluding cooked ham [ HRQ4vsQ1 = 1.90 ( 1.18-3 .05 ) , Ptrend = 0.005 ] .
RESULTS	In stratified analyses , processed meat intake was directly associated with breast cancer risk in the placebo group only [ HRQ4vsQ1 = 2.46 ( 1.28-4 .72 ) , Ptrend = 0.001 ] , but not in the supplemented group [ HRQ4vsQ1 = 0.86 ( 0.45-1 .63 ) , Ptrend = 0.7 ] .
CONCLUSIONS	Processed meat intake was prospectively associated with increased breast cancer risk .
CONCLUSIONS	This study also suggests that antioxidants may modulate this association by counteracting the potential pro-carcinogenic effects of processed meat on breast cancer .

###24512053
OBJECTIVE	To evaluate long-term safety and efficacy of tofogliflozin in Japanese patients with type 2 diabetes as monotherapy or in combination with other oral antidiabetic agents , we conducted 52-week , open-label , randomized controlled trials .
METHODS	The single-agent trial included patients with inadequate glycemic control on diet and exercise , whereas the add-on trial included those uncontrolled with any of the oral antidiabetic agents .
METHODS	In both trials , patients were randomly assigned to receive tofogliflozin 20 or 40 mg once daily orally for 52 weeks .
METHODS	Safety assessments .
RESULTS	A total of 194 patients ( 65 , 20-mg group ; 129 , 40-mg group ) were enrolled into the single-agent trial , whereas 602 ( 178 and 424 , respectively ) were enrolled into the add-on trial .
RESULTS	Tofogliflozin was well tolerated for 52 weeks in both trials with < 6 % of treatment discontinuation because of adverse events in each treatment group .
RESULTS	It also reduced hemoglobin A1c .
RESULTS	In the single-agent trial , mean reductions at 52 weeks were 0.67 and 0.66 % in the 20 - and 40-mg groups , respectively .
RESULTS	In the add-on trial , mean reductions ranged from 0.71 to 0.93 % across the subgroups by dose and background therapy .
CONCLUSIONS	Tofogliflozin was well tolerated and showed sustained efficacy in both trials .

###26035186
BACKGROUND	This 8-week , randomized , double-blind , placebo-controlled study , conducted August 2010-May 2012 in the United States , evaluated the safety and efficacy of vortioxetine 10 mg and 15 mg in patients with major depressive disorder ( MDD ) .
BACKGROUND	The mechanism of action of vortioxetine is thought to be related to direct modulation of serotonin ( 5-HT ) receptor activity and inhibition of the serotonin transporter .
METHODS	Adults aged 18-75 years with MDD ( DSM-IV-TR ) and Montgomery-Asberg Depression Rating Scale ( MADRS ) total score 26 were randomized ( 1:1:1 ) to receive vortioxetine 10 mg or 15 mg or placebo once daily , with the primary efficacy end point being change from baseline at week 8 in MADRS analyzed by mixed model for repeated measures .
METHODS	Adverse events were recorded during the study , suicidal ideation and behavior were assessed using the Columbia-Suicide Severity Rating Scale ( C-SSRS ) , and sexual dysfunction was assessed using the Arizona Sexual Experience ( ASEX ) scale .
RESULTS	Of the 1,111 subjects screened , 469 subjects were randomized : 160 to placebo , 157 to vortioxetine 10 mg , and 152 to vortioxetine 15 mg .
RESULTS	Differences from placebo in the primary efficacy end point were not statistically significant for vortioxetine 10 mg or vortioxetine 15 mg .
RESULTS	Nausea , headache , dry mouth , constipation , diarrhea , vomiting , dizziness , and flatulence were reported in 5 % of subjects receiving vortioxetine .
RESULTS	Discontinuation due to adverse events occurred in 7 subjects ( 4.4 % ) in the placebo group , 8 ( 5.2 % ) in the vortioxetine 10 mg group , and 12 ( 7.9 % ) in the vortioxetine 15 mg group .
RESULTS	ASEX total scores were similar across groups .
RESULTS	There were no clinically significant trends within or between treatment groups on the C-SSRS , laboratory values , electrocardiogram , or vital sign parameters .
CONCLUSIONS	In this study , vortioxetine did not differ significantly from placebo on MADRS total score after 8 weeks of treatment in MDD subjects .
BACKGROUND	ClinicalTrials.gov identifier : NCT01179516 .

###25129967
OBJECTIVE	To examine the value of self-treatment for Posterior canal benign paroxysmal positional vertigo ( PC-BPPV ) .
OBJECTIVE	The treatment effect was compared between patients treated with modified Epley in outpatient clinic combined with self treatment at home and patients treated by modified Epley alone .
METHODS	A randomized controlled trial were carried out in the Department of Otolaryngology Head and Neck Surgery , the Affiliated Sixth People 's Hospital of Shanghai Jiao Tong University from December 2012 to May 2013.147 out of 150 patients with unilateral idiopathic BPPV-PSC were enrolled in follow-up .
METHODS	Among which , 73 patients were allocated in modified Epley-alone group and 74 were allocated in slef-treatment group .
RESULTS	The success rate was 53.4 % in modified Epley-alone group vs 83.8 % in self-treatment group ( P < 0.01 ) after 1 week treatment .
RESULTS	In the modified Epley-alone group , the success rate of hand repositioning group and chair-assisted repositioning group was 45.9 % vs 61.1 % ( P > 0.05 ) , the risk rate was 0.752 , 95 % CI ( 0.486 - 1.163 ) .
RESULTS	In the self-treatment group , the success rate of hand repositioning group and chair-assisted repositioning group was 87.5 % vs 81.0 % ( P > 0.05 ) , the risk rate was 1.081 , 95 % CI ( 0.888-1 .316 ) .
RESULTS	Incidence rate of serious complications was 0 % in the modified Epley-alone group and 1.3 % in the self-treatment group ( P > 0.05 ) .
CONCLUSIONS	Complementary self-treatment with modified Epley maneuver treated PC-BPPV sooner and more effectively , Compared with modified Epley maneuver alone .
CONCLUSIONS	And its incidence rate of serious complications did n't increase .
CONCLUSIONS	Chair-assisted repositioning showed better result than hand repositioning alone , and self-treatment at home can reduce the effect of the gap .
CONCLUSIONS	We found that complementary self-treatment with modified Epley maneuver had more benefits for patients with PC-BPPV .

###24824018
BACKGROUND	The use of isotonic electrolytic solutions for the intraoperative fluid management in children is largely recognized , but the exact composition still needs to be defined .
OBJECTIVE	The primary objective of this randomized controlled open trial was to compare the changes in chloride plasma concentration using two intraoperative isotonic fluid regimens ( Sterofundin vs. normal saline , both added with 1 % of glucose ) in children undergoing major surgery .
OBJECTIVE	Secondary objectives were to compare changes in other electrolytes , renal function , and the occurrence of hypoglycemia .
METHODS	Children aged between 1 and 36 months , scheduled for major surgery , were randomized to receive Sterofundin or saline during the intraoperative time .
METHODS	Children with preoperative electrolyte abnormalities , hemodynamic instability , and severe renal or hepatic dysfunction were excluded .
METHODS	The primary outcome was the of Cl ( - ) ( = change in plasma concentration between post - and pre-infusion ) , and secondary outcomes included of other electrolytes and intraoperative hypoglycemia .
RESULTS	A total of 240 patients were included in the two study sites and randomized to receive Sterofundin plus 1 % glucose or normal saline plus 1 % glucose , in a open fashion ( 229 were finally analyzed ) .
RESULTS	of Cl - and Mg + + was statistically less relevant in patients who received intraoperative Sterofundin , and of the other electrolytes was comparable between the two study groups .
RESULTS	Relative risk of hyperchloremia was significantly higher when large volumes were infused ( over than 46.7 mlkg ( -1 ) ) , regardless of type of crystalloid infused .
RESULTS	Hypoglycemia occurred in two of 229 patients .
CONCLUSIONS	Sterofundin is safer than normal saline in protecting young children undergoing major surgery against the risk of increasing plasma chlorides and the subsequent metabolic acidosis .

###24970876
OBJECTIVE	Treatment with azathioprine within 3 months of remission induction with cyclophosphamide is a common treatment strategy for patients with ANCA-associated vasculitis .
OBJECTIVE	This study comprised patients undergoing long-term follow-up who were randomly allocated to azathioprine after 3-6 months or after 12 months of cyclophosphamide treatment .
METHODS	Patients from 39 European centers between 1995 and 1997 with a new diagnosis of ANCA-associated vasculitis that involved the kidneys or another vital organ were eligible .
METHODS	At the time of diagnosis , participants were randomly allocated to convert to azathioprine after 3-6 months ( the azathioprine group ) or after 12 months of cyclophosphamide ( the cyclophosphamide group ) .
METHODS	Patients who did not achieve a remission within 6 months were excluded .
METHODS	This study assessed relapses , ESRD , and death during long-term follow-up .
RESULTS	Patients were allocated to the azathioprine group ( n = 71 ) and the cyclophosphamide group ( n = 73 ) .
RESULTS	Of these patients , 63 ( 43.8 % ) developed a relapse , 35 ( 24.3 % ) developed a renal relapse , 13 ( 9.0 % ) developed ESRD , and 21 ( 14.6 % ) died .
RESULTS	Although there were worse outcomes in the azathioprine group , none were statistically significant .
RESULTS	The subdistribution hazard ratio [ sHR ] for relapse was 1.63 ( 95 % confidence interval [ 95 % CI ] , 0.99 to 2.71 ) , the composite of relapse or death hazard ratio [ HR ] was 1.59 ( 95 % CI , 1.00 to 2.54 ) , the ESRD sHR was 1.71 ( 95 % CI , 0.56 to 5.19 ) , and the death HR was 0.75 ( 95 % CI , 0.32 to 1.79 ) .
CONCLUSIONS	It remains uncertain whether converting to azathioprine after 3-6 months of induction cyclophosphamide therapy is as effective as converting after 12 months .
CONCLUSIONS	Outcomes are still poor for this group of patients and further research is required to determine the optimal timing of maintenance therapy .

###24520780
OBJECTIVE	To evaluate the efficacy and safety of Chinese medicine ( CM ) intervention in the treatment of nonalcoholic steatohepatitis ( NASH ) from liver enzyme ( ALT ) , imaging ( the liver/spleen CT ratio ) and syndrome scores , and to establish standard methods for diagnosis and therapeutic efficacy evaluation with characteristics of CM .
METHODS	A multi-center , stratified randomized , parallel controlled , blindness-method evaluated , superiority trial was performed .
METHODS	Totally 204 patients were randomly allocated into two groups , 102 patients in the experimental group ( treated with CM ) and 102 patients in the control group [ treated with Western medicine ( WM ) ] .
METHODS	The alanine aminotransferase ( ALT ) , liver/spleen CT ratio , and clinical symptoms were observed in both groups .
RESULTS	Of the randomly allocated 204 cases from 4 hospitals , 3 patients were rejected , and 25 were lost .
RESULTS	Totally 176 cases con - formed to the plan with complete follow-ups .
RESULTS	After 3 months of treatment , syndrome scores and the improvement of partial clinical symptoms ( fatigue and sallow complexion ) were superior in the experimental group to those in the control group ( P < 0.05 ) .
RESULTS	After 3 months of follow-up , the syndrome scores and improvement of partial clinical symptoms ( fatigue and sallow complexion ) were superior in the experimental group to those in the control group ( P < 0.05 ) .
RESULTS	There was no statistical difference in improving liver enzymes or the liver/spleen CT ratio between the two groups ( P > 0.05 ) .
RESULTS	There were 4 adverse reactions/adverse events in the two groups in the process of treatment , mainly covering drug-induced liver injury , diarrhea , and epigastric distension .
RESULTS	Adverse reactions had nothing to do with CM treatment .
CONCLUSIONS	Jianpi Shugan Recipe had obvious efficacy in treatment of NASH .
CONCLUSIONS	It could remove the liver fat and play a role in anti-inflammation and liver protection .
CONCLUSIONS	It also could improve the indices of liver enzymes and the liver/spleen CT ratio effectively , which was superior to Polyene Phosphatidylcholine Capsule ( PPC ) in improving clinical symptoms , especially for such symptoms as fatigue and sallow complexion .

###24484726
BACKGROUND	Chronic obstructive pulmonary disease ( COPD ) is a chronic inflammatory disease mediated by an array of inflammatory cells and mediators , but above all , CD8 + T-lymphocytes , macrophages and neutrophils are important players in disease pathogenesis .
BACKGROUND	Roflumilast , a first-in-class , potent and selective phosphodiesterase 4 ( PDE4 ) inhibitor , reduces the rate of exacerbations in patients with a high risk of future exacerbations and has been shown to reduce inflammatory cells and mediators in induced sputum , a surrogate of airway inflammation .
BACKGROUND	However , these anti-inflammatory effects are yet to be confirmed in another robust study directly assessing inflammatory markers in bronchial sub-mucosa .
METHODS	An international , 16-week , randomized , double-blind , placebo-controlled , parallel-group study investigating the effects of roflumilast 500 g once-daily versus placebo on inflammatory parameters in bronchial biopsy tissue specimens , sputum and blood serum .
METHODS	One hundred and fifty patients with COPD and chronic bronchitis for at least 12 months will be recruited into the study and randomized in a 1:1 ratio to receive either roflumilast or placebo .
METHODS	The primary endpoint will be the number of CD8 + cells ( cell counts per mm2 ) in bronchial biopsy tissue specimens ( sub-mucosa ) and the key secondary endpoint will be the number of CD68 + cells ( cell counts per mm2 ) , assessed by indirect immunohistochemistry .
CONCLUSIONS	It is hypothesized that treatment with roflumilast reduces the characteristic inflammation found in the airways of patients with moderate-to-severe COPD , compared with placebo .
CONCLUSIONS	The design of the present study has built on the work of previous bronchial biopsy studies available in the literature .
CONCLUSIONS	It is hoped that it will reveal the cellular mechanisms underlying the anti-inflammatory effects of roflumilast and identify potentially important biomarkers and other surrogate endpoints in patients with COPD .
CONCLUSIONS	The design and rationale for this trial are described herein .

###24767604
BACKGROUND	Obesity during pregnancy is associated with adverse outcomes for the offspring and mother .
BACKGROUND	Lifestyle interventions in pregnancy such as antenatal exercise , are proposed to improve both short - and long-term health of mother and child .
BACKGROUND	We hypothesise that regular moderate-intensity exercise during the second half of pregnancy will result in improved maternal and offspring outcomes , including a reduction in birth weight and adiposity in the offspring , which may be protective against obesity in later life .
METHODS	The IMPROVE ( Improving Maternal and Progeny Risks of Obesity Via Exercise ) study is a two-arm parallel randomised controlled clinical trial being conducted in Auckland , New Zealand .
METHODS	Overweight and obese women ( BMI 25kg/m2 ) aged 18-40 years , with a singleton pregnancy of < 20weeks of gestation , from the Auckland region , are eligible for the trial .
METHODS	Exclusion criteria are ongoing smoking or medical contra-indications to antenatal exercise.Participants are randomised with 1:1 allocation ratio to either intervention or control group , using computer-generated randomisation sequences in variable block sizes , stratified on ethnicity and parity , after completion of baseline assessments .
METHODS	The intervention consists of a 16-week structured home-based moderate-intensity exercise programme utilising stationary cycles and heart rate monitors , commencing at 20 weeks of gestation .
METHODS	The control group do not receive any exercise intervention .
METHODS	Both groups undergo regular fetal ultrasonography and receive standard antenatal care .
METHODS	Due to the nature of the intervention , participants are un-blinded to group assignment during the trial.The primary outcome is offspring birth weight .
METHODS	Secondary offspring outcomes include fetal and neonatal body composition and anthropometry , neonatal complications and cord blood metabolic markers .
METHODS	Maternal outcomes include weight gain , pregnancy and delivery complications , aerobic fitness , quality of life , metabolic markers and post-partum body composition .
CONCLUSIONS	The results of this trial will provide valuable insights on the effects of antenatal exercise on health outcomes in overweight and obese mothers and their offspring .
BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12612000932864 .

###26087573
OBJECTIVE	This randomized clinical trial assessed the effect of three different prosthetic abutments ( titanium , gold-hue titanium and zirconia ) on peri-implant soft tissue 2 years after treatment in partially edentulous subjects .
METHODS	Baseline data concerning ( 1 ) thickness of the buccal peri-implant soft tissue , ( 2 ) soft tissue thickness above the bone crest , ( 3 ) depth/length of transmucosal pathway , and ( 4 ) periodontal biotype at adjacent teeth were collected .
METHODS	The final sample consisted of 47 subjects ( 21 males , 26 females ) with a total of 97 implants .
METHODS	A two-level ( patient , implant ) statistical model was applied .
RESULTS	At the 2-year clinical observation , recession of the gingival margin was observed only at 13 % of implants irrespective of the type of abutment .
RESULTS	No significant correlation between periodontal biotype at adjacent teeth and peri-implant biotype was observed .
RESULTS	Furthermore , none of the investigated variables at patient level ( age , gender , implant type , periodontal biotype ) or at implant level ( keratinized tissue thickness , probing depth , soft tissue thickness ) was identified as a significant predictor of recession .
RESULTS	In conclusion , this study pointed out that ( 1 ) abutment type was not able to influence peri-implant variables after 2 years , and ( 2 ) caution should be used in considering periodontal biotype at patient level as a possible indicator of the future peri-implant biotype .

###25213203
BACKGROUND	Transient post-ischemic LV dysfunction due to myocardial stunning in patients with coronary artery disease can be missed by conventional gated SPECT ( GSPECT ) acquisitions .
BACKGROUND	The aim of this IAEA-sponsored multi-center study was to determine whether early post-exercise imaging is more likely to detect stunning than conventional without adversely affecting image quality or perfusion information .
RESULTS	Patients undergoing exercise/rest GSPECT were enrolled in this international multicenter study .
RESULTS	Post-exercise studies were acquired at 15 5 minutes after radiotracer injection ( Stress-1 ) and repeated at 60 15 minutes ( Stress-2 ) .
RESULTS	Rest studies ( R ) were acquired at 60 minutes post injection .
RESULTS	A core laboratory quantitatively assessed perfusion pattern and LV blinded to the acquisition time .
RESULTS	Ischemia was defined as summed stress score ( SDS ) 4 , and stunning was defined as the difference between rest and post-stress LVEF ( - LVEF ) .
RESULTS	In the 229 patients enrolled into the study , both image quality and perfusion information were similar between Stress-1 and Stress-2 .
RESULTS	Post-stress LVEF was associated with both ischemia and time of acquisition , with a significant correlation between SDS and - LVEF , which was stronger at Stress-1 than Stress-2 in the ischemic compared to the non-ischemic population ( r = 0.23 vs 0.08 , P = 0.10 ) .
CONCLUSIONS	Early post-exercise imaging is feasible , and can potentially improve the detection of post-ischemic stunning without compromising image quality and perfusion data .

###24719123
OBJECTIVE	The aim of this study was to evaluate and compare the long-term clinical outcomes of the spot drug-eluting stent ( DES ) implantation strategy , which is used to minimize implanted stent length and the number of stents , versus full lesion coverage for treatment of coronary artery stenoses .
METHODS	We evaluated 1-year clinical outcomes of 1619 patients with stent implantation for a single coronary lesion .
METHODS	They were divided into two groups : those treated by full lesion coverage ( n = 1200 ) and those treated with the spot stenting strategy ( n = 419 ) .
METHODS	The combined occurrence of 1-year target vessel failure ( TVF ) , including cardiac death , target-vessel related myocardial infarction , or ischemia-driven target-vessel revascularization was evaluated .
RESULTS	The spot DES implantation group had a shorter stent length ( 23.149.70 mm vs. 25.4413.24 mm , respectively ; p < 0.001 ) and a fewer number of stents ( 1.090.30 vs. 1.160.41 , respectively ; p < 0.001 ) , even though the average lesion length was similar to the full lesion coverage group ( 21.3610.30 mm vs. 20.5810.97 mm , respectively ; p = 0.206 ) .
RESULTS	Spot DES implantation was superior to full DES coverage with respect to 1-year TVF ( 1.4 % vs. 3.3 % , p = 0.044 ) .
RESULTS	Cox proportional hazard model analysis showed that the risk for 1-year TVF was almost 60 % lower among patients who received spot DESs compared to those who received full DES coverage after adjustment for other risk factors ( HR = 0.40 , 95 % confidence interval = 0.17-0 .98 ; p = 0.046 ) .
CONCLUSIONS	Minimizing stent length and the number of stents with overlapping by spot DES implantation may result in reduced rates of 1-year TVF , compared with full DES coverage .

###25060610
OBJECTIVE	To compare pro re nata ( PRN ) and monthly injections of 0.5 mg ranibizumab in retinal vein occlusion ( RVO ) patients stabilized by monthly injections .
METHODS	Randomized , open-label , vision-examiner masked , 15-month study .
METHODS	Subjects with macular edema secondary to branch or central RVO .
METHODS	Subjects received monthly injections of 0.5 mg ranibizumab for 7 months and those meeting stability criteria between months 7 and 14 were randomized ( 1:1 ) to PRN injections versus continued monthly injections .
METHODS	Non-randomized ( NR ) subjects ( never met stability criteria ) received monthly injections .
METHODS	The primary endpoint was the slope of change in best-corrected visual acuity ( BCVA ) between months 7 and 15 .
RESULTS	There was no significant difference in the slope of change in BCVA between months 7 and 15 in patients treated PRN versus those treated with monthly injections ( P = 0.509 ) .
RESULTS	Mean ( standard deviation ) change from baseline BCVA in Early Treatment Diabetic Retinopathy Study letter score at month 15 was 21.0 14.1 in the PRN group ( n = 82 ) versus 18.7 14.1 in the monthly group ( n = 80 ) and 14.5 14.7 in NR subjects ( n = 13 ) .
RESULTS	The percentage of subjects who achieved BCVA 20/40 at month 15 was 76.8 % in the PRN group , 71.3 % in the monthly group , and 46.2 % in NR subjects .
RESULTS	The mean ( standard deviation ) change from baseline central subfield thickness was -247.8 207.5 m in the PRN group , -289.9 177.2 m in the monthly group , and -93.2 225.2 m in NR subjects .
RESULTS	There were no significant differences in mean BCVA gains or central subfield thickness reductions at month 15 between the PRN and monthly injection groups ( all > 0.05 ) .
CONCLUSIONS	After edema resolution from 7 or more monthly ranibizumab injections in RVO subjects , visual outcomes at month 15 were excellent and not significantly different in subjects treated PRN versus those who continued monthly injections .

###25193534
OBJECTIVE	To determine whether a 3-month contraceptive vaginal ring ( CVR ) delivering ulipristal acetate ( UPA ) can inhibit ovulation in 90 % of cycles .
METHODS	This was a randomized dose-finding parallel group clinical trial .
METHODS	Fifty-five healthy women with normal ovulation at baseline were randomized to receive a low-dose ( 1500 g/day ) or a high-dose ( 2500 g/day ) UPA-CVR for two consecutive 12-week treatment periods , followed by a recovery cycle .
METHODS	A subgroup of women received levonorgestrel ( LNG ) 1.5 mg orally twice ( at the end of both 12-week ring periods ) or once ( at the end of the 24-week treatment ) .
METHODS	The primary outcome was ovulation suppression assessed by transvaginal ultrasound and hormone levels .
METHODS	Secondary outcomes included endometrial safety and bleeding patterns .
RESULTS	All subjects showed normal ovulation at baseline and recovery .
RESULTS	Ovulation suppression was seen in 81.8 % ( 95 % CI : 73.3 % , 88.5 % ) and 86.1 % ( 95 % CI : 78.1 % , 92 % ) of treatment cycles with low and high-dose , respectively .
RESULTS	Benign progesterone receptor modulator associated endometrial changes ( PAEC ) were seen during treatment ; 78.8 % at week 24 , but resolved at recovery cycle .
RESULTS	A few cases of heavy bleeding occurred near the end of the 24-week treatment , but a single dose of LNG every 12 weeks reduced the increase in endometrial thickness during the second treatment period and prevented excessive bleeding .
CONCLUSIONS	The 3-month UPA-CVR may become an effective long-acting , user-controlled estrogen-free contraceptive .
CONCLUSIONS	The greatest suppression of ovulation was seen with the 2500-g/day ring .
CONCLUSIONS	The 3-month CVR delivering UPA 2500 g/day can become an effective user-controlled estrogen-free contraceptive method .
CONCLUSIONS	Benign PAEC during treatment returns to normal after discontinuation .
CONCLUSIONS	The prevention of occasional excessive withdrawal bleeding , either by a progestin or by using higher UPA levels to increase follicle suppression may permit prolonged treatment .

###25416687
BACKGROUND	Docetaxel/cisplatin/infusional 5-fluorouracil ( 5-FU ; DCF ) is a standard chemotherapy regimen for patients with advanced gastric cancer ( GC ) .
BACKGROUND	This phase II study evaluated docetaxel/oxaliplatin ( TE ) , docetaxel/oxaliplatin/5-FU ( TEF ) , and docetaxel/oxaliplatin/capecitabine ( TEX ) in patients with advanced GC .
METHODS	Patients with metastatic or locally recurrent gastric adenocarcinoma ( including carcinoma of the gastro-oesophageal junction ) were randomly assigned ( 1 : 1 : 1 ) to TE , TEF , or TEX. .
METHODS	Each regimen was tested at two doses before full evaluation at optimized dose levels .
METHODS	The primary end point was progression-free survival ( PFS ) .
METHODS	Overall survival ( OS ) , tumour response , and safety were also assessed .
METHODS	A therapeutic index ( median PFS relative to the incidence of febrile neutropenia ) was calculated for each regimen and compared with DCF ( historical data ) .
RESULTS	Overall , 248 patients were randomly assigned to receive optimized dose treatment .
RESULTS	Median PFS was longer with TEF ( 7.66 [ 95 % confidence interval ( CI ) : 6.97-9 .40 ] months ) versus TE ( 4.50 [ 3.68-5 .32 ] months ) and TEX ( 5.55 [ 4.30-6 .37 ] months ) .
RESULTS	Median OS was 14.59 ( 95 % CI : 11.70-21 .78 ) months for TEF versus 8.97 ( 7.79-10 .87 ) months for TE and 11.30 ( 8.08-14 .03 ) months for TEX. .
RESULTS	The rate of tumour response ( complete or partial ) was 46.6 % ( 95 % CI 35.9-57 .5 ) for TEF versus 23.1 % ( 14.3-34 .0 ) for TE and 25.6 % ( 16.6-36 .4 ) for TEX. .
RESULTS	The frequency and type of adverse events ( AEs ) were similar across the three arms .
RESULTS	Common grade 3/4 AEs were fatigue ( 21 % ) , sensory neuropathy ( 14 % ) , and diarrhoea ( 13 % ) .
RESULTS	Febrile neutropenia was reported in 2 % ( TEF ) , 14 % ( TE ) , and 9 % ( TEX ) of patients .
RESULTS	The therapeutic index was improved with TEF versus TEX , TE , or DCF .
CONCLUSIONS	These results suggest that TEF is worthy of evaluation as an arm in a phase III trial or as a backbone regimen for new targeted agents in advanced GC .
CONCLUSIONS	CLINICALTRIALS.GOV : Identifier Trial registration number : NCT00382720 .

###24418365
BACKGROUND	Procollagen 1 amino-terminal propeptide ( P1NP ) is a bone formation marker and has been shown to have a strong association with the extent of bone metastases ( BM ) in patients with advanced prostate cancer .
BACKGROUND	More recently , its levels were found to be affected by androgen deprivation therapies and bisphosphonates .
BACKGROUND	We investigated the role of P1NP as a surrogate marker of sub-radiological skeletal metastases in prostate cancer patients with biochemical failure ( BF ) .
METHODS	BePrepared is a prospective longitudinal substudy of RADAR trial in which serial P1NPs were collected at regular intervals for 123 patients who had completed RADAR protocol treatment .
RESULTS	There was no trend identified in P1NP levels prior to diagnosis of BM .
RESULTS	We found that there was no difference in P1NP concentrations at the time of diagnosis of BM in the group that developed BM compared with P1NP levels in groups with only nodal metastases or BF .
RESULTS	In the group of patients who did not experience BF , P1NP was affected by previous luteinizing hormone-releasing hormone-agonist and bisphosphonate therapy .
RESULTS	Hence , patients who received an 18-month course of androgen deprivation without bisphosphonates had significantly higher P1NP values than patients with shorter androgen deprivation therapy ( ADT ) course combined with a course of bisphosphonates .
CONCLUSIONS	P1NP is not a sensitive serum marker of early BM in high-risk prostate cancer patients with BF and low prostate-specific antigen levels as its levels are affected by prior history of bone remodelling therapies such as ADT and bisphosphonates .

###24736197
OBJECTIVE	Postmenopausal bone loss can be exacerbated by environmental contaminants , including the heavy metal cadmium ( Cd ) .
OBJECTIVE	We hypothesized that incorporating phosphorus ( P ) into the diet would lead to the chelation of Cd into P , preventing its absorption and subsequent bone loss .
METHODS	To test this hypothesis , we used ovariectomized rats as a model of postmenopausal osteoporosis to examine the deleterious effects of Cd on bone with and without added P. Fifty 3-month-old ovariectomized Sprague-Dawley rats were assigned to five treatment groups ( n = 10 per group ) for 3 months as follows : ( 1 ) control ; ( 2 ) 50 ppm Cd ; ( 3 ) 50 ppm Cd plus 1.2 % P ; ( 4 ) 200 ppm Cd ; and ( 5 ) 200 ppm Cd plus 1.2 % P.
RESULTS	Cd plus P caused a significant loss of whole body ( P = 0.0001 and P < 0.001 ) and femoral ( P = 0.0005 and P < 0.001 ) bone mineral density ( BMD ) and bone mineral content , respectively , and a loss of fourth lumbar vertebra BMD and bone mineral content ( P < 0.0001 and P < 0.001 , respectively ) .
RESULTS	Nonetheless , 200 ppm Cd plus 1.2 % P had the most deleterious effects on whole body and femoral BMD .
RESULTS	For femoral neck microstructural properties , 50 ppm Cd plus 1.2 % P caused an increase in trabecular separation , whereas 200 ppm Cd plus 1.2 % P caused a decrease in bone volume-to-total volume ratio , a decrease in trabecular number , and an increase in trabecular separation and structural model index .
CONCLUSIONS	Our findings indicate that Cd exposure , along with high intake of P , may be a public health hazard with respect to bone health .

###24812894
OBJECTIVE	To evaluate the clinical efficacy and safety of integrative medical program based on blood cooling and detoxification recipe ( BCDR ) in treating patients with hepatitis B virus related acute-on-chronic liver failure ( HBV-ACLF ) of heat-toxicity accumulation syndrome ( HTAS ) .
METHODS	Adopting randomized controlled clinical design , a total of 105 HBV-ACLF patients of HTAS were randomly assigned to the trial group ( 64 cases ) and the control group ( 41 cases ) .
METHODS	Patients in the control group were treated with comprehensive Western therapy , while those in the trial group were treated with comprehensive Western therapy plus BCDR .
METHODS	All were treated for 8 weeks and followed up for 40 weeks .
METHODS	Effect and safety of the treatment were assessed , including fatality , liver functions [ total bilirubin ( TBIL ) , albumin ( ALB ) , alanine aminotransferase ( ALT ) , and aspartate transaminase ( AST ) ] , and prothrombin activity ( PTA ) after treatment and at week 48 of follow-ups .
RESULTS	After 8-week treatment , there was statistical difference in the overall fatality rate ( 15.63 % vs 34.15 % ) , the fatality rate in the mid-term ( 25.0 % vs 64.7 % ) , TBIL at week 8 ( 64.54 + / - 79.75 ) , AST [ at week 2 : ( 178.97 + / - 44.24 ) U/L vs ( 288.48 + / - 58.49 ) U/L ; at week 4 : ( 61.65 + / - 27.36 ) U/L vs ( 171.12 + / - 89.11 ) U/L ] and PTA [ at week 4 : ( 58.30 + / - 15.29 ) vs ( 42.56 + / - 15.27 ) ; at week 6 : ( 60.77 + / - 20.40 ) vs ( 43.08 + / - 12.79 ) ] ( all P < 0.05 ) .
RESULTS	At week 48 of the followup , the fatality rate of the trial group ( 21.88 % ) decreased by 17.14 % when compared with that of the control group ( 39.02 % ; P < 0.05 ) .
RESULTS	No obvious adverse event occurred in the two groups during the 8-week treatment period .
CONCLUSIONS	BCDR could significantly reduce the mortality of HBV-ACLF patients .

###24906838
OBJECTIVE	This study was conducted for the nutritional assessment of cancer patients undergoing radiotherapy ( RT ) and to investigate the changes in nutrition status , oral intake , morbidity and quality of life ( QOL ) in cancer patients after intensive nutrition counseling .
METHODS	Eighty-seven cancer patients were randomized to either a nutrition counseling group ( n = 44 , age 58.02.2 years ) or a control group ( n = 43 , 62.01.8 years ) .
METHODS	Nutrition counseling accompanied RT , and the subjects received at least three sessions of individualized dietary counseling over the duration of RT. .
METHODS	Assessment parameters were nutritional intake ( 24-h recall method ) , nutritional status Patient-Generated Subjective Global Assessment ( PG-SGA ) , QOL and blood parameters including albumin .
METHODS	All parameters were measured at baseline , at the end of RT , and 1 month after the termination of RT. .
RESULTS	Body weight , body mass index ( BMI ) , and energy and protein intake for the intervention and control groups did not differ significantly between baseline and the end of RT. .
RESULTS	However , at 1 month follow-up , protein intake was significantly decreased in the control group ( p < 0.05 ) .
RESULTS	Blood albumin , total protein ( TP ) , total lymphocyte count ( TLC ) were not different between the two groups .
RESULTS	According to PG-SGA stage , at 1 month follow-up , patients in the intervention group showed increased number of patients with stage A status ( well nourished ) .
RESULTS	In addition , insomnia and nausea was significantly improved in the intervention group assessed by QOL .
CONCLUSIONS	We suggest that repetitive and intensive nutritional counseling is necessary to improve QOL and to prevent deterioration of nutritional status in cancer patients receiving RT. .

###25371347
BACKGROUND	Gentamicin is an aminoglycoside antibiotic that is highly effective in treating Gram-negative infections , but inappropriate use leads to toxicity .
BACKGROUND	In 2010 , the Australian Therapeutic Guidelines ( Antibiotic ) were revised to recommend the use of computerised methods to individualise dosing of gentamicin and optimise therapy , rather than traditional nomogram approaches .
OBJECTIVE	To determine whether gentamicin prescribing was compliant with the Australian Therapeutic Guidelines , version 14 ( 2010 ) in a setting where computerised dose recommendation resources and computerised decision support were available , and to determine why the resources were effective or ineffective in achieving compliance to guidelines .
METHODS	During phase 1 , a retrospective audit of gentamicin prescribing from 1 January 2012 to 31 December 2012 ( n = 826 ) at a 320-bed teaching hospital in Sydney was undertaken .
METHODS	In phase 2 , 12 doctors from specialties with high-volume prescribing of gentamicin were interviewed .
RESULTS	Intravenous gentamicin was used in 545 cases , 81 % of which were for short-term therapy ( 48h ) .
RESULTS	Doctors feared inducing toxicity in patients , but limited the dose rather than altering the dosing interval according to renal function .
RESULTS	Of the ` continued ' dosing cases , 55 % went unmonitored and the computerised dose recommendation service was rarely used .
RESULTS	Doctors were unaware of its availability despite electronic alerts accompanying prescriptions of gentamicin .
CONCLUSIONS	In comparison with the national guidelines , there was significant under-dosing and monitoring practices were haphazard .
CONCLUSIONS	Computerised electronic alerts were ineffective in informing users .
CONCLUSIONS	To improve prescribing practices , we recommend exploring alternative computerised decision support approaches ( e.g. pre-written orders ) and more pervasive and persuasive implementation strategies .

###24970570
BACKGROUND	The construction of a colostomy is a common procedure , but the evidence for the different parts of the construction of the colostomy is lacking .
BACKGROUND	Parastomal hernia is a common complication of colostomy formation .
BACKGROUND	The aim of this study is to standardise the colostomy formation and to compare three types of colostomy formation ( one including a mesh ) regarding the development of parastomal hernia .
METHODS	Stoma-Const is a Scandinavian randomised trial comparing three types of colostomy formation .
METHODS	The primary endpoint is parastomal herniation as shown by clinical examination or CT scan within one year .
METHODS	Secondary endpoints are re-admission rate , postoperative complications ( classified according to Clavien-Dindo ) , stoma-related complications ( registered in the case record form at stoma care nurse follow-up ) , total length of hospital stay during 12months , health-related quality of life and health economic analysis as well as re-operation rate and mortality within 30days and 12months of primary surgery .
METHODS	Follow-up is scheduled at 4-6 weeks , and 6 and 12months .
METHODS	Inclusion is set at 240 patients .
CONCLUSIONS	Parastomal hernia is a common complication after colostomy formation .
CONCLUSIONS	Several studies have been performed with the aim to reduce the rate of this complication .
CONCLUSIONS	However , none are fully conclusive and data on quality of life and health economy are lacking .
CONCLUSIONS	The aim of this study is to develop new standardised techniques for colostomy formation and evaluate this with patient reported outcomes as well as clinical and radiological assessment .
BACKGROUND	Clinicaltrials.gov , NCT01694238.2012-09-24 .

###25659828
BACKGROUND	Zonisamide has been associated with weight loss in children and adults .
OBJECTIVE	To assess the effects of adjunctive zonisamide on weight and body mass index ( BMI ) in children with partial epilepsy .
METHODS	A subanalysis was conducted of a Phase III trial and extension study , in which children with partial epilepsy received adjunctive zonisamide ( target dose 8 mg/kg/day ; maximum 500 mg/day ) .
METHODS	Changes in weight were correlated with skeletal development and sexual maturation .
RESULTS	Overall , 179 children ( 93 male , 86 female ; age 6-18 years ) received zonisamide ( mean duration 370.6 days ) .
RESULTS	Weight loss 5 % was reported for 64 of 179 ( 35.8 % ) zonisamide-treated children .
RESULTS	Of these , 46.9 % were overweight/obese at study entry , compared with 23.4 % at study end ( P = 0.0007 ) ; 48.4 % had normal weight at study entry , compared with 65.6 % at study end ( P = 0.03 ) .
RESULTS	Three patients were underweight at study entry , and four more became underweight by study end .
RESULTS	No consistent correlations between weight loss and skeletal development or sexual maturation were observed .
CONCLUSIONS	Approximately one-third of children treated with zonisamide experienced 5 % weight loss .
CONCLUSIONS	Weight loss was most apparent in children with high baseline BMI values and did not appear to be associated with any consistent effects on growth and development .

###24238498
BACKGROUND	A multi-center large scale study is needed to confirm the efficacy and safety of domestic peritoneal dialysis ( PD ) solutions .
BACKGROUND	Some researchers believe that 6 L/d is enough for adequate dialysis , but there is no multi-center prospective study on Chinese population to confirm this .
BACKGROUND	In this study , we evaluated the efficacy and safety of domestic PD solution ( Changfu ) and its difference between 6 L and 8 L dosage .
METHODS	Adult PD patients who had taken PD therapy for at least one month were selected and divided into four groups according to two dialysis solution brands and two dialysis dosages , i.e. , 6 L dose with Changfu dialysis solution , 6 L dose with Baxter dialysis solution , 8 L dose with Changfu dialysis solution , and 8 L dose with Baxter dialysis solution .
METHODS	After 48 weeks , the changes of primary and secondary efficacy indices were compared between different types and different dosages .
METHODS	We also analyzed the changes of safety indices .
RESULTS	Changes of Kt/V from baseline to 48 weeks between Changfu and Baxter showed no statistical differences ; so did those of creatinine clearance rate ( Ccr ) .
RESULTS	Normalized protein catabolic rate ( nPCR ) from baseline to 48 weeks between Changfu and Baxter showed no statistical differences ; so did those of net ultrafiltration volume ( nUF ) and estimated glomerular filtration rate ( eGFR ) .
RESULTS	Changes of nPCR from baseline to 48 weeks between 6 L and 8 L showed no statistical differences ; so did those of nUF and eGFR .
RESULTS	The decline of Kt/V from baseline to 48 weeks in 6 L group was more than that in 8 L group .
RESULTS	Change of Ccr was similar .
RESULTS	During the 48-week period , the mean Kt/V was above 1.7 / w , and mean Ccr was above 50 L1 .73 m ( -2 ) w ( -1 ) .
RESULTS	More adverse events were found in Changfu group before Changfu Corporation commenced technology optimization , and the statistical differences disappeared after that .
CONCLUSIONS	The domestic PD solution ( Changfu ) was proven to be as effective as Baxter dialysis solution .
CONCLUSIONS	During 48-week period , a dosage of 6 L/d was enough for these patients to reach adequate PD .
CONCLUSIONS	Clinical study promotes technological optimization , further helps to improve the safety indices of the medical products .

###25497165
OBJECTIVE	To assess and compare efficacy , pain , and the learning curve associated with diagnostic therapeutic hysteroscopy using mechanical tissue removal versus bipolar electrical resection in the management of endometrial polyps in an ambulatory care setting .
METHODS	A randomized controlled clinical trial ( Canadian Task Force classification I ) .
METHODS	Hospital de Igulada , Barcelona , Spain .
METHODS	A total of 133 patients diagnosed with endometrial polyp ( s ) were included and randomly assigned to 1 of the 2 hysteroscopic methods .
METHODS	Criteria assessed were total hysteroscopy time , full polypectomy procedure time , pain experienced by patients , and learning curve of staff in training .
RESULTS	The average time to perform total hysteroscopy using the mechanical tissue removal system ( TRUCLEAR 5.0 System ; Smith & Nephew Inc. , Andover , MD ) was 6 minutes 49 seconds versus 11 minutes 37 seconds required for the bipolar electrosurgery system ( GYNECARE VERSAPOINT ; Ethicon Inc , Somerville , NJ ) ( p < .01 ) .
RESULTS	Results for complete polypectomy time favored the TRUCLEAR System at 3 minutes 7 seconds over the VERSAPOINT System at 8 minutes 25 seconds ( p < .01 ) .
RESULTS	If a successful procedure is predicated on access to cavity , visualization , and complete resection and excision of endometrial polyp , the mechanical TRUCLEAR Tissue Removal System shows a higher success rate than the VERSAPOINT Bipolar Electrosurgery System at 92 % and 77 % , respectively .
RESULTS	Analysis of pain using the visual analog scale revealed no significant differences between the 2 techniques ( p > .05 ) .
RESULTS	A study of the residents ' learning curve showed a higher level of autonomy with hysteroscopy using the TRUCLEAR Tissue Removal System with which residents showed a higher level of confidence compared with hysteroscopy with the VERSAPOINT Bipolar Electrosurgery System .
CONCLUSIONS	In hysteroscopic polypectomy , the mechanical tissue removal system was significantly faster , achieved a greater success rate for complete polypectomy , and required a shorter learning curve from staff being trained in the management of endometrial polyps when compared with bipolar electrical resection .

###24511099
BACKGROUND	Complicated skin and skin structure infections ( cSSSIs ) are characterized by infections with gram-positive or gram-negative aerobic or anaerobic bacteria , as well as by a polymicrobial etiology .
BACKGROUND	These invading microorganisms are recognized by pattern-recognition receptors ( PRRs ) of the innate immune system .
BACKGROUND	This study assessed whether genetic variation in genes encoding PRRs influences the susceptibility to cSSSIs .
METHODS	A total of 318 patients with cSSSI and 328 healthy controls were genotyped for 9 nonsynonymous single-nucleotide polymorphisms ( SNPs ) in PRR genes coding for Toll-like receptors ( TLRs ) 1 , 2 , 4 , and 6 ; NOD-like receptor 2 ; and the signaling adaptor molecule TIRAP .
METHODS	Associations between susceptibility to cSSSIs and a SNP were investigated by means of logistic regression models .
METHODS	In an additional cohort of 74 healthy individuals in whom the same SNPs were genotyped , peripheral blood mononuclear cells ( PBMCs ) were obtained and stimulated with Staphylococcus aureus .
METHODS	Interleukin 6 concentrations were determined in supernatants by enzyme-linked immunosorbent assay to determine the correlation between genotypes and levels of IL-6 secretion .
RESULTS	In the genetic association analysis , polymorphisms in TLR1 ( S248N and R80T ) , TLR2 ( P631H ) , and TLR6 ( P249S ) were associated with an increased susceptibility to cSSSIs .
RESULTS	No association with susceptibility to cSSSIs was observed for polymorphisms TLR2 ( R753Q ) , TLR4 ( D299G and T399I ) , NOD2 ( P268S ) , and TIRAP ( S180L ) .
RESULTS	In the functional analysis , individuals bearing the TLR1 248N or 80T allele showed lower IL-6 secretion upon stimulation with S. aureus .
CONCLUSIONS	Polymorphisms in TLR1 , TLR2 , and TLR6 are associated with increased susceptibility to cSSSIs .
CONCLUSIONS	For TLR1 , impaired proinflammatory cytokine production due to the polymorphism is most likely the mechanism mediating this effect .

###24424708
OBJECTIVE	Cognitive benefits of multivitamins have been observed in the elderly , but fewer trials have investigated younger , healthy cohorts .
OBJECTIVE	This randomised , double-blind , placebo-controlled study investigated the cognitive effects of 16-week multivitamin supplementation in adults aged 20-49years .
METHODS	A total of 138 participants aged 20-50years were randomised and 116 completed the trial .
METHODS	The participants completed a computerised battery of cognitive tasks before and after 16-week supplementation with a multivitamin containing minerals and herbs or placebo .
METHODS	Blood measures of homocysteine , vitamin B6 , B12 and folate were collected at both time points .
RESULTS	In men , there was a strong trend ( p = 0.01 ; which did not reach significance when adjusted for multiple comparisons ) for the multivitamin to improve performance on the incongruent stroop task , a measure of selective attention and response inhibition .
RESULTS	There were no cognitive benefits of multivitamin supplements in women .
RESULTS	Multivitamin supplementation substantially increased blood levels of vitamin B6 , B12 and folate in both genders and decreased homocysteine in men .
RESULTS	In men who received the multivitamin , improved stroop congruent performance was associated with increased vitamin B6 levels .
CONCLUSIONS	Multivitamin supplementation may be useful for maintaining levels of B vitamins .
CONCLUSIONS	The effects of multivitamins on speeded attention such as the stroop task in young adults warrant further investigation .

###25012407
BACKGROUND	Current cognitive behavioral models of hoarding view hoarding as a multifaceted problem stemming from various information processing deficits .
BACKGROUND	However , there is also reason to suspect that the consequences of hoarding may in turn impact or modulate deficits in information processing .
BACKGROUND	The current study sought to expand upon the existing literature by manipulating clutter to examine whether the presence of a cluttered environment affects information processing .
METHODS	Participants included 34 individuals with hoarding disorder .
METHODS	Participants were randomized into a clutter or non-clutter condition and asked to complete various neuropsychological tasks of memory and attention .
RESULTS	Results revealed that hoarding severity was associated with difficulties in sustained attention .
RESULTS	However , individuals in the clutter condition relative to the non-clutter condition did not experience greater deficits in information processing .
CONCLUSIONS	Limitations include the cross-sectional design and small sample size .
CONCLUSIONS	The current findings add considerably to a growing body of literature on the relationships between information processing deficits and hoarding behaviors .
CONCLUSIONS	Research of this type is integral to understanding the etiology and maintenance of hoarding .

###25125506
OBJECTIVE	To evaluate the safety and efficacy of methazolamide as a potential therapy for type 2 diabetes .
METHODS	This double-blind , placebo-controlled study randomized 76 patients to oral methazolamide ( 40 mg b.i.d. ) or placebo for 24 weeks .
METHODS	The primary efficacy end point for methazolamide treatment was a placebo-corrected reduction in HbA1c from baseline after 24 weeks ( HbA1c ) .
RESULTS	Mean SD baseline HbA1c was 7.1 0.7 % ( 54 5 mmol/mol ; n = 37 ) and 7.4 0.6 % ( 57 5 mmol/mol ; n = 39 ) in the methazolamide and placebo groups , respectively .
RESULTS	Methazolamide treatment was associated with a HbA1c of -0.39 % ( 95 % CI -0.82 , 0.04 ; P < 0.05 ) ( -4.3 mmol/mol [ -9.0 , 0.4 ] ) , an increase in the proportion of patients achieving HbA1c 6.5 % ( 48 mmol/mol ) from 8 to 33 % , a rapid reduction in alanine aminotransferase ( 10 units/L ) , and weight loss ( 2 % ) in metformin-cotreated patients .
CONCLUSIONS	Methazolamide is the archetype for a new intervention in type 2 diabetes with clinical benefits beyond glucose control .

###24977996
OBJECTIVE	Although procedural sedation using intravenous agents is highly effective for forearm fracture reduction , the process is both resource and time intensive .
OBJECTIVE	Our objective was to determine whether the use of a hematoma block as an adjunct to procedural sedation with ketamine and midazolam reduces ( 1 ) pain during the procedure ( scored using the Observational Score for Behavioral Distress-Revised score ) or ( 2 ) the excess sedation time , defined by the time between procedure completion and discharge from sedation .
OBJECTIVE	Our secondary outcome measure was total ketamine dose administered during the procedure .
METHODS	A randomized , double-blind , placebo-controlled clinical trial was conducted .
METHODS	Before fracture reduction , children 3 to 17 years of age randomly received 2 % lidocaine ( L ) or normal saline ( NS ) into the hematoma of their fracture site during sedation with intravenous ketamine and midazolam .
RESULTS	Ninety patients were randomized : 50 to L and 40 to NS .
RESULTS	The groups were similar with regard to age , sex , type of fracture , and prior administration of pain medication .
RESULTS	Median Observational Score for Behavioral Distress-Revised scores were 1.11 and 1.69 for the L and NS groups , respectively ( P = 0.23 ) .
RESULTS	Excess sedation time was not significantly different between the groups ( P = 0.36 ) , with a median excess sedation time of 33.0 and 36.0 minutes for the L and NS groups , respectively .
RESULTS	Mean ketamine dose administered was not different between the groups ( P = 0.42 ) .
RESULTS	The mean total dose administered was 1.00 mg/kg and 1.07 mg/kg in the L and NS groups , respectively .
RESULTS	Mean midazolam dose was 0.05 mg/kg for both groups .
CONCLUSIONS	The use of a hematoma block as an adjunct to procedural sedation with ketamine and midazolam for forearm fracture reduction conferred no additional benefit and did not decrease observed pain scores , excess sedation time , or total ketamine dose administered .

###25932553
OBJECTIVE	This study assessed the safety , tolerability , and pharmacodynamics of emixustat hydrochloride ( ACU-4429 ) , a novel visual cycle modulator , in subjects with geographic atrophy associated with dry age-related macular degeneration .
METHODS	Subjects were randomly assigned to oral emixustat ( 2 , 5 , 7 , or 10 mg once daily ) or placebo ( 3:1 ratio ) for 90 days .
METHODS	Recovery of rod photoreceptor sensitivity after a photobleach was measured by electroretinography .
METHODS	Safety evaluations included analysis of adverse events and ophthalmic examinations .
RESULTS	Seventy-two subjects ( 54 emixustat and 18 placebo ) were evaluated .
RESULTS	Emixustat suppressed rod photoreceptor sensitivity in a dose-dependent manner .
RESULTS	Suppression plateaued by Day 14 and was reversible within 7 days to 14 days after drug cessation .
RESULTS	Most systemic adverse events were not considered treatment related .
RESULTS	Dose-related ocular adverse events ( chromatopsia , 57 % emixustat vs. 17 % placebo and delayed dark adaptation , 48 % emixustat vs. 6 % placebo ) were mild to moderate in severity , and the majority resolved on study or within 7 days to 14 days after study drug cessation .
RESULTS	Reversibility of these adverse events with long-term administration , however , is undetermined .
CONCLUSIONS	In this Phase II study , emixustat produced a dose-dependent reversible effect on rod function that is consistent with the proposed mechanism of action .
CONCLUSIONS	These results support further testing of emixustat for the treatment of geographic atrophy associated with dry age-related macular degeneration .

###24655865
BACKGROUND	Various surgical meshes are used in the repair of inguinal hernia and are associated with numerous complications .
BACKGROUND	Our main objective in this study was to determine whether a biologic hernia matrix is equivalent to polypropylene mesh in an open inguinal hernia repair using the Lichtenstein technique .
METHODS	A prospective , randomized , double-blinded , single-center trial was conducted to evaluate the efficacy of a biologic Inguinal Hernia Matrix ( IHM ; Cook Medical ) compared with polypropylene ( PP ) mesh using Lichtenstein 's inguinal hernia repair in a 3-year outcomes study .
METHODS	Patients were evaluated for recurrence and complications by a blinded surgeon at 2 weeks , 3 months , 6 months , and 1 year post procedure .
METHODS	Patient demographics , including comorbidities and nutrition status , were recorded .
METHODS	Intraoperative information including hernia type and location , procedure time , level of difficulty , degree of surgeon frustration , and surgical experience were collected .
RESULTS	One hundred male patients provided informed consent and were randomized into the study in a 1:1 fashion .
RESULTS	There were no significant differences in degree of difficulty and level of frustration between the 2 groups .
RESULTS	At 1-year follow-up , 3 recurrences were diagnosed in the IHM group as compared with none in the PP group ( p = 0.11 ) .
RESULTS	Persistent pain trended higher in the PP group ( 6 % vs 4 % ) .
RESULTS	All 3 recurrences occurred in the direct inguinal hernia group and were performed by attendings in the first year post training ( 3 different attendings ) .
RESULTS	No recurrences occurred in patients operated on by more senior surgeons .
CONCLUSIONS	The IHM hernioplasty compares favorably with PP mesh at 1-year follow-up with similar recurrence rates and complications .
CONCLUSIONS	Surgeon experience appears to be a major factor affecting successful outcomes .

###24322378
OBJECTIVE	The authors compared the effectiveness of 50 sessions of schema therapy with clarification-oriented psychotherapy and with treatment as usual among patients with cluster C , paranoid , histrionic , or narcissistic personality disorder .
METHODS	A multicenter randomized controlled trial , with a single-blind parallel design , was conducted between 2006 and 2011 in 12 Dutch mental health institutes .
METHODS	A total of 323 patients with personality disorders were randomly assigned ( schema therapy , N = 147 ; treatment as usual , N = 135 ; clarification-oriented psychotherapy , N = 41 ) .
METHODS	There were two cohorts of schema therapy therapists , with the first trained primarily with lectures and the second primarily with exercises .
METHODS	The primary outcome was recovery from personality disorder 3 years after treatment started ( assessed by blinded interviewers ) .
METHODS	Secondary outcomes were dropout rates and measures of personality disorder traits , depressive and anxiety disorders , general psychological complaints , general and social functioning , self-ideal discrepancy , and quality of life .
RESULTS	A significantly greater proportion of patients recovered in schema therapy compared with treatment as usual and clarification-oriented psychotherapy .
RESULTS	Second-cohort schema therapists had better results than first-cohort therapists .
RESULTS	Clarification-oriented psychotherapy and treatment as usual did not differ .
RESULTS	Findings did not vary with specific personality disorder diagnosis .
RESULTS	Dropout was lower in the schema therapy and clarification-oriented psychotherapy conditions .
RESULTS	All treatments showed improvements on secondary outcomes .
RESULTS	Schema therapy patients had less depressive disorder and higher general and social functioning at follow-up .
RESULTS	While interview-based measures demonstrated significant differences between treatments , differences were not found with self-report measures .
CONCLUSIONS	Schema therapy was superior to treatment as usual on recovery , other interview-based outcomes , and dropout .
CONCLUSIONS	Exercise-based schema therapy training was superior to lecture-based training .

###25575254
OBJECTIVE	To reduce the incidence of incisional hernia ( IH ) in colorectal surgery by implanting a mesh on the overlay position .
BACKGROUND	The incidence of IH in colorectal surgery may be as high as 40 % .
BACKGROUND	IH causes severe health and cosmetic problems , and its repair increases health care costs .
METHODS	Randomized , controlled , prospective trial .
METHODS	Patients undergoing any colorectal procedure ( both elective and emergency ) through a midline laparotomy were divided into 2 groups .
METHODS	The abdomen was closed with an identical technique in both groups , except for the implantation of an overlay large-pore polypropylene mesh in the study group .
METHODS	Patients were followed up clinically and radiologically for 24 months .
RESULTS	A total of 107 patients were included : 53 in the study group and 54 in the control group .
RESULTS	Both groups were homogeneous , except for a higher incidence of diabetes in the mesh group .
RESULTS	There were 20 emergency procedures in the study group and 17 in the control group .
RESULTS	There were no statistical differences in surgical site infections , seromas , or mortality between the groups ( 33.3 % , 13.8 % , and 3.7 % in the control group and 18.9 % , 13.2 % , and 3.8 % in the study group ) .
RESULTS	No mesh rejection was reported .
RESULTS	The incidence of IH was 17 of 54 ( 31.5 % ) in the control group and 6 of 53 ( 11.3 % ) in the study group ( P = 0.011 ) .
CONCLUSIONS	The incidence of IH is high in patients undergoing elective or emergency surgery for colorectal diseases .
CONCLUSIONS	The addition of a prophylactic large-pore polypropylene mesh on the overlay position decreases the incidence of IH without adding morbidity .

###24344222
OBJECTIVE	The purpose of this trial was to evaluate the effect of a Web-based , self-report assessment and educational intervention on symptom distress during cancer therapy .
METHODS	A total of 752 ambulatory adult participants were randomly assigned to symptom/quality-of-life ( SxQOL ) screening at four time points ( control ) versus screening , targeted education , communication coaching , and the opportunity to track/graph SxQOL over time ( intervention ) .
METHODS	A summary of the participant-reported data was delivered to clinicians at each time point in both groups .
METHODS	All participants used the assessment before a new therapeutic regimen , at 3 to 6 weeks and 6 to 8 weeks later , completing the final assessment at the end of therapy .
METHODS	Change in Symptom Distress Scale-15 ( SDS-15 ) score from pretreatment to end of study was compared using analysis of covariance and regression analysis adjusting for selected variables .
RESULTS	We detected a significant difference between study groups in mean SDS-15 score change from baseline to end of study : 1.27 ( standard deviation [ SD ] , 6.7 ) in the control group ( higher distress ) versus -0.04 ( SD , 5.8 ) in the intervention group ( lower distress ) .
RESULTS	SDS-15 score was reduced by an estimated 1.21 ( 95 % CI , 0.23 to 2.20 ; P = .02 ) in the intervention group .
RESULTS	Baseline SDS-15 score ( P < .001 ) and clinical service ( P = .01 ) were predictive .
RESULTS	Multivariable analyses suggested an interaction between age and study group ( P = .06 ) ; in subset analysis , the benefit of intervention was strongest in those age > 50 years ( P = .002 ) .
CONCLUSIONS	Web-based self-care support and communication coaching added to SxQOL screening reduced symptom distress in a multicenter sample of participants with various diagnoses during and after active cancer treatment .
CONCLUSIONS	Participants age > 50 years , in particular , may have benefited from the intervention .

###24691112
BACKGROUND	Findings from inflammatory bowel disease ( IBD ) genome-wide association studies are being translated clinically into prognostic and diagnostic indicators of disease .
BACKGROUND	Yet , patient perception and understanding of these tests and their applicability to providing risk information is unclear .
BACKGROUND	The goal of this study was to determine , using hypothetical scenarios , whether patients with IBD perceive genetic testing to be useful for risk assessment , whether genetic test results impact perceived control , and whether low genetic literacy may be a barrier to patient understanding of these tests .
METHODS	Two hundred fifty seven patients with IBD from the Johns Hopkins gastroenterology clinics were randomized to receive a vignette depicting either a genetic testing scenario or a standard blood testing scenario .
METHODS	Participants were asked questions about the vignette and responses were compared between groups .
RESULTS	Perceptions of test utility for risk assessment were higher among participants responding to the genetic vignette ( P < 0.001 ) .
RESULTS	There were no significant differences in perceptions of control over IBD after hypothetical testing between vignettes ( P = 0.24 ) .
RESULTS	Participant responses were modified by genetic literacy , measured using a scale developed for this study .
RESULTS	Participants randomized to the genetic vignette who scored higher on the genetic literacy scale perceived greater utility of testing for risk assessment ( P = 0.008 ) and more control after testing ( P = 0.02 ) .
CONCLUSIONS	Patients with IBD perceive utility in genetic testing for providing information relevant to family members , and this appreciation is promoted by genetic literacy .
CONCLUSIONS	Low genetic literacy among patients poses a potential threat to effective translation of genetic and genomic tests .

###25228838
OBJECTIVE	Recent epidemiological studies revealed a striking inverse relationship between vitamin D levels , glucose intolerance/insulin resistance ( IR ) , and cardiovascular disease .
OBJECTIVE	However , few interventional studies have evaluated the effect of vitamin D supplementation on cardiovascular risk , such as IR and arterial stiffness , in diabetes .
OBJECTIVE	We investigated the role of vitamin D supplementation on cardiovascular risk in type 2 diabetes patients , including metabolic parameters , IR , and arterial stiffness .
METHODS	We enrolled patients who were taking antidiabetic medications or managed their diabetes using lifestyle changes .
METHODS	We excluded patients who were taking vitamin D or calcium supplements .
METHODS	We randomized participants into the vitamin D group ( cholecalciferol 2,000 IU/day + calcium 200 mg/day , n = 40 ) or the placebo group ( calcium 200 mg/day , n = 41 ) .
METHODS	We compared their IR ( homeostasis model of assessment [ HOMA ] - IR ) and arterial stiffness ( brachial-ankle pulse wave velocity and radial augmentation index ) before and after 24 weeks of intervention .
RESULTS	The baseline characteristics of the two groups were similar .
RESULTS	A total of 62 participants ( placebo , 30 ; vitamin D , 32 ) completed the study protocol .
RESULTS	At the end of the study period , the 25-hydroxyvitamin D [ 25 ( OH ) D ] levels were significantly higher in the vitamin D group than in the placebo group ( 35.4 8.5 ng/mL vs. 18.4 7.3 ng/mL , p < 0.001 ) .
RESULTS	There was no difference in HOMA-IR or changes in arterial stiffness ( placebo , 21 , vitamin D , 24 ) between the groups .
CONCLUSIONS	Our data suggest that high-dose vitamin D supplementation might be effective in terms of elevating 25 ( OH ) D levels .
CONCLUSIONS	However , we identified no beneficial effects on cardiovascular risk in type 2 diabetes , including IR and arterial stiffness .

###24672232
OBJECTIVE	To determine the efficacy and safety of Curcuma domestica extracts in pain reduction and functional improvement .
METHODS	367 primary knee osteoarthritis patients with a pain score of 5 or higher were randomized to receive ibuprofen 1,200 mg/day or C. domestica extracts 1,500 mg/day for 4 weeks .
METHODS	The main outcomes were Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) total , WOMAC pain , WOMAC stiffness , and WOMAC function scores .
METHODS	Adverse events ( AEs ) were also recorded .
RESULTS	185 and 182 patients were randomly assigned into C. domestica extracts and ibuprofen groups , respectively .
RESULTS	The baseline characteristics were no different between groups .
RESULTS	The mean of all WOMAC scores at weeks 0 , 2 , and 4 showed significant improvement when compared with the baseline in both groups .
RESULTS	After using the noninferiority test , the mean difference ( 95 % confidence interval ) of WOMAC total , WOMAC pain , and WOMAC function scores at week 4 adjusted by values at week 0 of C. domestica extracts were noninferior to those for the ibuprofen group ( P = 0.010 , P = 0.018 , and P = 0.010 , respectively ) , except for the WOMAC stiffness subscale , which showed a trend toward significance ( P = 0.060 ) .
RESULTS	The number of patients who developed AEs was no different between groups .
RESULTS	However , the number of events of abdominal pain/discomfort was significantly higher in the ibuprofen group than that in the C. domestica extracts group ( P = 0.046 ) .
RESULTS	Most subjects ( 96 % -97 % ) were satisfied with the treatment , and two-thirds rated themselves as improved in a global assessment .
CONCLUSIONS	C. domestica extracts are as effective as ibuprofen for the treatment of knee osteoarthritis .
CONCLUSIONS	The side effect profile was similar but with fewer gastrointestinal AE reports in the C. domestica extracts group .

###24822236
OBJECTIVE	To evaluate the effectiveness of a prefabricated appliance and compare it to the effectiveness of a stabilization appliance in patients with temporomandibular joint ( TMJ ) pain .
METHODS	This randomized , controlled multicenter study comprised 48 patients diagnosed with TMJ arthralgia according to the Research Diagnostic Criteria for Temporomandibular Disorders .
METHODS	The effectiveness of a prefabricated appliance ( Relax ) , worn by half of the patients ( referred to as the R group ) , was compared to the effectiveness of a stabilization appliance , worn by the other half of patients ( S group ) .
METHODS	Treatment outcome was assessed according to the recommendations by the Initiative on Methods , Measurement , and Pain Assessment in Clinical Trials ( IMMPACT ) on an intent-to-treat basis .
METHODS	To analyze the differences between groups , the chi-square test and the Mann-Whitney U test were used , while the Friedman analysis of variance ( ANOVA ) on ranks was used for the analyses between baseline data and follow-up measurements , all with a significance level set at P < .05 .
RESULTS	There were no differences between the groups at baseline .
RESULTS	A 30 % reduction of pain intensity was reported by 62.5 % of the R group and 58.3 % of the S group at the 10-week follow-up ; 58 % and 50.3 % , respectively , at the 6-month follow-up ; and 41.7 % in both groups at 12 months .
RESULTS	At the 12-month follow-up , pain intensity had decreased and physical function had improved in both groups ( P < .005 and P < .016 , respectively ) , without significant group differences .
RESULTS	Emotional function ( depression and nonspecific physical symptoms ) did not change .
RESULTS	Overall improvement of `` better '' to `` symptom-free '' was observed in 67 % of the R group and 58 % of the S group .
RESULTS	No side effects occurred .
CONCLUSIONS	The effectiveness of the prefabricated appliance seems to be similar to that of the stabilization appliance in alleviating TMJ pain .
CONCLUSIONS	Since the prefabricated appliance requires only one visit for construction , it is convenient for both the general practitioner and for the patient .

###24799602
BACKGROUND	Low 25-hydroxyvitamin D ( 25 ( OH ) D ) has been associated with increased HIV mortality , but prospective studies assessing treatment outcomes after combination antiretroviral therapy ( cART ) initiation in resource-limited settings are lacking .
METHODS	A case-cohort study ( N = 411 ) was nested within a randomized cART trial of 1571 cART-naive adults in 8 resource-limited settings and the United States .
METHODS	The primary outcome ( WHO stage 3/4 disease or death within 96 weeks of cART initiation ) was met by 192 cases , and 152 and 29 cases met secondary outcomes of virologic and immunologic failure .
METHODS	We studied prevalence and risk factors for baseline low 25 ( OH ) D ( < 32 ng/mL ) and examined associated outcomes using proportional hazard models .
RESULTS	Low 25 ( OH ) D prevalence was 49 % and ranged from 27 % in Brazil to 78 % in Thailand .
RESULTS	Low 25 ( OH ) D was associated with high body mass index ( BMI ) , winter/spring season , country-race group , and lower viral load .
RESULTS	Baseline low 25 ( OH ) D was associated with increased risk of human immunodeficiency virus ( HIV ) progression and death ( adjusted hazard ratio ( aHR ) 2.13 ; 95 % confidence interval [ CI ] , 1.09-4 .18 ) and virologic failure ( aHR 2.42 ; 95 % CI , 1.33-4 .41 ) .
CONCLUSIONS	Low 25 ( OH ) D is common in diverse HIV-infected populations and is an independent risk factor for clinical and virologic failure .
CONCLUSIONS	Studies examining the potential benefit of vitamin D supplementation among HIV patients initiating cART are warranted .

###25319597
BACKGROUND	Domestic violence and abuse ( DVA ) are associated with an increased risk of mental illness , but we know little about the mental health of female DVA survivors seeking support from domestic violence services .
OBJECTIVE	Domestic violence and abuse ( DVA ) are associated with an increased risk of mental illness , but we know little about the mental health of female DVA survivors seeking support from domestic violence services .
METHODS	Baseline data on 260 women enrolled in a randomized controlled trial of a psychological intervention for DVA survivors was analyzed .
METHODS	We report prevalence of and associations between mental health status and severity of abuse at the time of recruitment .
METHODS	We used logistic and normal regression models for binary and continuous outcomes , respectively .
METHODS	Mental health measures used were : Clinical Outcomes in Routine Evaluation-Outcome Measure ( CORE-OM ) , Patient Health Questionnaire , Generalized Anxiety Disorder Assessment , and the Posttraumatic Diagnostic Scale ( PDS ) to measure posttraumatic stress disorder .
METHODS	The Composite Abuse Scale ( CAS ) measured abuse .
RESULTS	Exposure to DVA was high , with a mean CAS score of 56 ( SD 34 ) .
RESULTS	The mean CORE-OM score was 18 ( SD 8 ) with 76 % above the clinical threshold ( 95 % confidence interval : 70-81 % ) .
RESULTS	Depression and anxiety levels were high , with means close to clinical thresholds , and all respondents recorded PTSD scores above the clinical threshold .
RESULTS	Symptoms of mental illness increased stepwise with increasing severity of DVA .
CONCLUSIONS	Exposure to DVA was high , with a mean CAS score of 56 ( SD 34 ) .
CONCLUSIONS	The mean CORE-OM score was 18 ( SD 8 ) with 76 % above the clinical threshold ( 95 % confidence interval : 70-81 % ) .
CONCLUSIONS	Depression and anxiety levels were high , with means close to clinical thresholds , and all respondents recorded PTSD scores above the clinical threshold .
CONCLUSIONS	Symptoms of mental illness increased stepwise with increasing severity of DVA .

###24423018
BACKGROUND	Women who have survived breast cancer have hot flushes that are `` significantly more frequent , severe , distressing , and of greater duration '' than in other women .
BACKGROUND	We compared the efficacy and safety of stellate ganglion block and pregabalin for the relief of hot flushes in breast cancer survivors .
METHODS	Forty patients who were breast cancer survivors and were suffering from hot flushes to the degree that they seeked for treatment were included in the study and randomly divided into two groups : group I : ( N = 20 ) stellate ganglion block was done for the patients of this group ; and group II : ( N = 20 ) in this group , the patients received 75mg pregabalin twice daily .
METHODS	In both groups self-completed daily hot flush diaries and monthly symptom questionnaires were obtained at baseline and for the following 3 months .
RESULTS	Our results showed that group I ( stellate ganglion block ) had significant ( P < 0.05 ) decline in the frequency of mild , moderate , very severe , and total hot flushes in comparison with group II ( pregabalin 75mg twice daily ) throughout the 3 months of follow up period .
CONCLUSIONS	The stellate ganglion block had superior efficacy in the management of hot flushes in breast cancer survivors .

###24408211
BACKGROUND	The treatment of obesity is an increasing global health priority , yet few effective drug treatments are currently available .
BACKGROUND	The discovery of novel anti-obesity therapies could be assisted by the validation of experimental ( translational ) medicine models in healthy volunteers that assess efficacy and safety at an early stage of drug development .
OBJECTIVE	The aim of this study was to examine the effects of the 5-HT2C receptor agonist meta-chlorophenylpiperazine ( mCPP ) in an experimental medicine model assessing both appetite and mood .
METHODS	Using a between-subjects , double-blind , placebo-controlled design , 24 male and 24 female participants were randomly assigned to either placebo , 15 - or 30-mg mCPP treatment groups .
METHODS	Lunch was eaten from a Universal Eating Monitor ( UEM ) that measured eating rate , and the participants completed the P1vital Oxford Emotional Test Battery ( ETB ) and a series of appetite and mood ratings .
RESULTS	mCPP reduced appetite and , in women , enhanced measures of satiation .
RESULTS	The drug also enhanced memory for emotional material in the word recall and recognition memory tasks of the ETB .
CONCLUSIONS	The results provide new insight into the effects of mCPP on appetite , satiety and memory in humans .
CONCLUSIONS	In addition , our data provide an illustration of the value of measuring changes in appetite and mood in healthy volunteers to determine the potential efficacy and safety of novel anti-obesity drugs .

###25205802
BACKGROUND	The long-term outcomes of transcatheter aortic valve replacement ( TAVR ) in inoperable patients with severe aortic stenosis remain unknown .
RESULTS	In the Placement of Aortic Transcatheter Valves ( PARTNER ) study , 358 patients were randomly assigned to TAVR or standard therapy .
RESULTS	We report the 3-year outcomes on these patients , and the pooled outcomes for all randomly assigned inoperable patients ( n = 449 ) in PARTNER , as well , including the randomized portion of the continued access study ( n = 91 ) .
RESULTS	The 3-year mortality rate in the TAVR and standard therapy groups was 54.1 % and 80.9 % , respectively ( P < 0.001 ; hazard ratio , 0.53 ; 95 % confidence interval , 0.41-0 .68 ; P < 0.001 ) .
RESULTS	In survivors , there was significant improvement in New York Heart Association functional class sustained at 3 years .
RESULTS	The cumulative incidence of strokes at 3-year follow-up was 15.7 % in TAVR patients versus 5.5 % in patients undergoing standard therapy ( hazard ratio , 2.81 ; 95 % confidence interval , 1.26-6 .26 ; P = 0.012 ) ; however , the composite of death or strokes was significantly lower after TAVR versus standard therapy ( 57.4 % versus 80.9 % , P < 0.001 ; hazard ratio , 0.60 ; 95 % confidence interval , 0.46-0 .77 ; P < 0.001 ) .
RESULTS	Echocardiography showed a sustained increase in aortic valve area and decrease in transvalvular gradient after TAVR .
RESULTS	Analysis of the 449 pooled randomly assigned patients ( TAVR , n = 220 ; standard therapy , n = 229 ) demonstrated significant improvement in all-cause mortality and functional status during early and 3-year follow-up .
RESULTS	The results of the pooled cohort were similar to the results obtained from the pivotal PARTNER trial .
CONCLUSIONS	TAVR resulted in better survival and functional status in inoperable patients with severe aortic stenosis with durable hemodynamic benefit on long-term follow-up .
CONCLUSIONS	However , high residual mortality , even in successfully treated TAVR patients , highlights the need for more strategic patient selection .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00530894 .

###24225337
BACKGROUND	Subjective clinical improvement does not always go hand-in-hand with right ventricular ( RV ) reverse remodeling after surgery for isolated severe tricuspid regurgitation ( TR ) .
BACKGROUND	This study aimed to evaluate the level of agreement between clinical improvement and echocardiographic RV reverse remodeling , and determine the relative prognostic powers of these 2 factors in terms of long-term prognosis for patients with isolated TR surgery .
RESULTS	Sixty-one consecutive patients ( 588 years ) were included .
RESULTS	During a median follow up of 55 months ( IQR , 36.571.5 months ) , a composite endpoint including death and admission for right heart failure was investigated .
RESULTS	Extents of reductions in RV end-systolic area ( RV-ESA ) and subjective clinical improvement at 6 months were examined .
RESULTS	There were 6 deaths and 5 admissions for right heart failure .
RESULTS	A reduction in RV-ESA of > 20 % effectively predicted event-free survival , with a sensitivity of 90.9 % and a specificity of 72.0 % ( AUC 0.81 , P = 0.001 ) .
RESULTS	With this cut-off , the agreement between a clinical and echocardiographic response was only 57.4 % ( 35 patients ) .
RESULTS	On Cox regression analysis , RV-ESA change emerged as the only independent predictor of event-free survival , whereas subjective clinical improvement did not .
CONCLUSIONS	A discrepancy between subjective and echocardiographic improvement at 6 months after isolated TR surgery was observed in 42.6 % of the patients .
CONCLUSIONS	Echocardiographic RV reverse remodeling , but not subjective clinical amelioration , was a strong prognosticator after surgery .

###24838902
OBJECTIVE	The effects of acute continuous positive airway pressure therapy on left ventricular diastolic function and functional capacity in patients with compensated systolic heart failure remain unclear .
METHODS	This randomized , double-blind , placebo-controlled clinical trial included 43 patients with heart failure and a left ventricular ejection fraction < 0.50 who were in functional classes I-III according to the New York Heart Association criteria .
METHODS	Twenty-three patients were assigned to continuous positive airway pressure therapy ( 10 cmH2O ) , while 20 patients received placebo with null pressure for 30 minutes .
METHODS	All patients underwent a 6-minute walk test ( 6MWT ) and Doppler echocardiography before and immediately after intervention .
METHODS	Clinicaltrials.gov : NCT01088854 .
RESULTS	The groups had similar clinical and echocardiographic baseline variables .
RESULTS	Variation in the diastolic function index ( e ' ) after intervention was associated with differences in the distance walked in both groups .
RESULTS	However , in the continuous positive airway pressure group , this difference was greater ( continuous positive airway pressure group : 6MWT = 9.44 +16.05 e ' , p = 0.002 ; sham group : 6MWT = 7.49 +5.38 e ' ; p = 0.015 ) .
RESULTS	There was a statistically significant interaction between e ' index variation and continuous positive airway pressure for the improvement of functional capacity ( p = 0.020 ) .
CONCLUSIONS	Continuous positive airway pressure does not acurately change the echocardiographic indexes of left ventricle systolic or diastolic function in patients with compensated systolic heart failure .
CONCLUSIONS	However , 30-minute continuous positive airway pressure therapy appears to have an effect on left ventricular diastolic function by increasing functional capacity .

###25200462
OBJECTIVE	To explore if cognitive impairment in relapsing-remitting multiple sclerosis ( RRMS ) is associated with abnormal neural function and if there is evidence of neural compensatory mechanisms .
METHODS	Seventy-two RRMS patients and 89 healthy control subjects were included in a cross-sectional study .
METHODS	Event-related brain potential ( P300 ) and response time ( RT ) were recorded with visual and auditory choice reaction tasks .
METHODS	Cognitive function was evaluated with an 18 item test battery .
RESULTS	Patients had a decrease in cognitive function ( p < 0.001 for global score ) and increased visual P300 amplitude frontally .
RESULTS	P300 amplitude was normal in other brain areas and RT was normal .
RESULTS	P300 latency was normal except for an increase in auditory latency occipitally .
RESULTS	Cognitive performance correlated positively with parietal P300 amplitude in patients but not in controls .
RESULTS	Cognition had stronger correlation ( negative ) with RT in patients than in controls .
CONCLUSIONS	Patients with low P300 amplitude and long RT were more often cognitively impaired .
CONCLUSIONS	This indicates that general factors such as signal amplitude and speed are limiting for cognitive function in RRMS patients .
CONCLUSIONS	The increase in frontal P300 amplitude may be a compensatory effect .
CONCLUSIONS	Our findings suggest that high amplitude and fast speed may be protective against cognitive impairment .

###24474177
OBJECTIVE	To investigate the sedative and clinical effects of the pharmacopuncture with xylazine , compared to the conventional dose of a intramuscular injection in dogs .
METHODS	Twelve dogs were randomly distributed in two groups of six animals and treated as follows : control group ( X-IM ) : 1mg kg ( -1 ) of xylazine given intramuscularly ( IM ) ; pharmacopuncture group ( X-Yintang ) : 0.1 mg kg ( -1 ) of xylazine diluted to 0.5 mL of saline injected into the Yin Tang acupoint .
METHODS	Heart rate , cardiac rhythm ( ECG ) , systolic arterial blood pressure ( SABP ) , respiratory rate ( RR ) , rectal temperature ( RT ) , blood glucose concentration , degree of sedation and adverse effects were evaluated .
RESULTS	Sedative effect was observed in both groups .
RESULTS	The degree of sedation was greater in X-IM only at 15 min when compared with X-Yintang group .
RESULTS	Cardiovascular established was observed in X-Yintang group , while marked reduction in the HR and increased incidence of ECG abnormalities were detected in X-IM .
RESULTS	In both treatment groups , minimal changes were observed in relation to SABP , RR , RT and blood glucose .
RESULTS	High incidence ( 66 % ) of vomiting was observed in X-IM , while this adverse effect was absent in X-Yintang .
CONCLUSIONS	Pharmacopuncture with xylazine induced clinically relevant sedative effects in dogs , with the advantage of reduction of undesirable side effects associated with 2-agonists , including bradycardia , cardiac arrhythmias , and emesis .

###24565620
BACKGROUND	Poor adherence to inhaled corticosteroids ( ICS ) is a critical risk factor contributing to asthma morbidity among low-income minority adolescents .
OBJECTIVE	This trial tested whether peer support group meetings and peer asthma messages delivered via mp3 players improved adherence to ICS .
METHODS	Low-income African American and/or Hispanic adolescents , ages 11-16 years old , with persistent asthma , and poor ( 48 % ) adherence to prescription ICS during the 3-week run-in were randomized to intervention or attention control groups ( ATG ) for the 10-week treatment .
METHODS	During treatment , the intervention arm subjects participated in weekly coping peer group support sessions and received mp3 peer-recorded asthma messages that promoted adherence .
METHODS	The ATG participated in weekly meetings with a research assistant and received an equivalent number of mp3 physician-recorded asthma messages .
METHODS	Adherence was measured by using self-report and the Doser CT , an electronic dose counter .
METHODS	The primary outcome was the difference in adherence at 10 weeks between the 2 arms .
RESULTS	Thirty-four subjects were randomized to each arm .
RESULTS	At 10 weeks , no statistical difference in objectively measured adherence could be detected between the 2 arms when adjusting for baseline adherence ( P = .929 ) .
RESULTS	Adherence declined in both groups over the course of the active treatment period .
RESULTS	In both study arms , self-reported adherence by participants was significantly higher than their objectively measured adherence at week 10 ( P < .0001 ) .
CONCLUSIONS	Improving medication adherence in longitudinal studies is challenging .
CONCLUSIONS	Peer support and mp3-delivered peer asthma messages may not be of sufficient dose to improve outcomes .

###24983200
BACKGROUND	Recent studies have demonstrated higher-quality chest compressions ( CCs ) following a 60 s ultra-brief video ( UBV ) on compression-only CPR ( CO-CPR ) .
BACKGROUND	However , the effectiveness of UBVs as a CPR-teaching tool for lay bystanders in public venues remains unknown .
OBJECTIVE	Determine whether an UBV is effective in teaching laypersons CO-CPR in a public setting and if viewing leads to superior responsiveness and CPR skills .
METHODS	Adult lay bystanders were enrolled in a public shopping mall and randomized to : ( 1 ) Control ( CTR ) : sat idle for 60 s ; ( 2 ) UBV : watched a 60 s UBV on CO-CPR .
METHODS	Subjects were read a scenario detailing a sudden collapse in the mall and asked to do what they `` thought was best '' on a mannequin .
METHODS	Performance measures were recorded for 2 min : responsiveness ( time to call 911 and first CCs ) and CPR quality [ CC depth , rate , hands-off interval ( time without CC after first CC ) ] .
RESULTS	One hundred subjects were enrolled .
RESULTS	Demographics were similar between groups .
RESULTS	UBV subjects called 911 more frequently ( percent difference : 31 % ) and initiated CCs sooner in the arrest scenario ( median difference ( MD ) : 5 s ) .
RESULTS	UBV cohort had increased CC rate ( MD : 19 cpm ) and decreased hands-off interval ( MD : 27 s ) .
RESULTS	There was no difference in CC depth .
CONCLUSIONS	Bystanders with UBV training in a shopping mall had significantly improved responsiveness , CC rate , and decreased hands-off interval .
CONCLUSIONS	Given the short length of training , UBV may have potential as a ubiquitous intervention for public venues to help improve bystander reaction to arrest and CO-CPR performance .

###24762683
OBJECTIVE	To explore the eradication efficacies of triple versus quadruple furazolidone-based regimens for Helicobacter pylori ( H. pylori ) infection .
METHODS	A total of 357 outpatients with H. pylori infection were enrolled from June to December 2010 .
METHODS	There were 200 males and 157 females with an average age of ( 42 12 ) years .
METHODS	A diagnosis of duodenal ulcer was made according to their endoscopic examination results .
METHODS	They were randomly assigned into 4 treatment groups : 7-day triple ( n = 89 ) and 10-day triple ( n = 91 ) , rabeprazole 10 mg , amoxicillin 1 000 mg and furazolidone 100 mg twice daily for 7 and 10 days respectively .
METHODS	7-day quadruple ( n = 88 ) and 10-day quadruple ( n = 89 ) , rabeprazole 10 mg , bismuth 220 mg , amoxicillin 1 000 mg and furazolidone 100 mg twice daily for 7 and 10 days respectively.H .
METHODS	pylori status was re-assessed with ( 14 ) C-urea breath test after 4-week therapy .
RESULTS	Among them , 323 cases completed the study .
RESULTS	According to the analysis of intention-to-treat ( ITT ) , the H. pylori eradication rates were 71.91 % ( 64/89 ) in 7-day triple , 81.32 % ( 74/91 ) in 10-day triple , 78.41 % ( 69/88 ) in 7-day quadruple and 83.15 % ( 74/89 ) in 10-day quadruple groups .
RESULTS	No significant deviation existed among all groups ( P > 0.05 ) .
RESULTS	According the per-protocol ( PP ) analysis , H. pylori eradication rates were 78.05 % ( 64/82 ) in 7-day triple , 88.10 % ( 74/84 ) in 10-day triple , 87.34 % ( 69/79 ) in 7-day quadruple and 94.87 % ( 74/78 ) in 10-day quadruple groups .
RESULTS	Significant deviation existed among all groups ( P = 0.017 ) .
RESULTS	The H. pylori eradication rate in 10-day quadruple group was significantly higher than that in 7-day triple group ( P = 0.002 ) .
RESULTS	The total adverse reaction rate was 7.00 % ( 25/357 ) .
RESULTS	No significant difference existed among all groups ( P > 0.05 ) .
CONCLUSIONS	Quadruple treatments provide higher H. pylori eradication rates than triple therapies .
CONCLUSIONS	A 10-day treatment may improve H. pylori eradication rate .
CONCLUSIONS	And 10-day quadruple regimen with furazolidone and bismuth may be effective for H. pylori infection .

###24790271
BACKGROUND	Prior studies show that adaptive servoventilation ( ASV ) is initially more effective than continuous positive airway pressure ( CPAP ) for patients with complex sleep apnea syndrome ( CompSAS ) , but choosing therapies has been controversial because residual central breathing events may resolve over time in many patients receiving chronic CPAP therapy .
BACKGROUND	We conducted a multicenter , randomized , prospective trial comparing clinical and polysomnographic outcomes over prolonged treatment of patients with CompSAS , with CPAP versus ASV .
METHODS	Qualifying participants meeting criteria for CompSAS were randomized to optimized CPAP or ASV treatment .
METHODS	Clinical and polysomnographic data were obtained at baseline and after 90 days of therapy .
RESULTS	We randomized 66 participants ( 33 to each treatment ) .
RESULTS	At baseline , the diagnostic apnea-hypopnea index ( AHI ) was 37.7 27.8 ( central apnea index [ CAI ] = 3.2 5.8 ) and best CPAP AHI was 37.0 24.9 ( CAI 29.7 25.0 ) .
RESULTS	After second-night treatment titration , the AHI was 4.7 8.1 ( CAI = 1.1 3.7 ) on ASV and 14.1 20.7 ( CAI = 8.8 16.3 ) on CPAP ( P 0.0003 ) .
RESULTS	At 90 days , the ASV versus CPAP AHI was 4.4 9.6 versus 9.9 11.1 ( P = 0.0024 ) and CAI was 0.7 3.4 versus 4.8 6.4 ( P < 0.0001 ) , respectively .
RESULTS	In the intention-to-treat analysis , success ( AHI < 10 ) at 90 days of therapy was achieved in 89.7 % versus 64.5 % of participants treated with ASV and CPAP , respectively ( P = 0.0214 ) .
RESULTS	Compliance and changes in Epworth Sleepiness Scale and Sleep Apnea Quality of Life Index were not significantly different between treatment groups .
CONCLUSIONS	Adaptive servoventilation ( ASV ) was more reliably effective than CPAP in relieving complex sleep apnea syndrome .
CONCLUSIONS	While two thirds of participants experienced success with CPAP , approximately 90 % experienced success with ASV .
CONCLUSIONS	Because both methods produced similar symptomatic changes , it is unclear if this polysomnographic effectiveness may translate into other desired outcomes .
RESULTS	Clinicaltrials.Gov NCT00915499 .

###26182774
BACKGROUND	Carpal tunnel syndrome ( CTS ) is one of the commonest peripheral neuropathies which effects mainly middle aged women .
BACKGROUND	Different techniques are being tried to decrease the postoperative pain in patients operated for CTS .
BACKGROUND	The objective of this study was to compare effectiveness of local injection of steroid and mini incision technique in the treatment of carpal tunnel syndrome .
METHODS	This randomized control trial was conducted at department of Orthopedics and department of Neurosurgery , Ayub Teaching Hospital , Abbottabad from Aug 2011 to Feb 2013 .
METHODS	A total of 116 patients of CTS were randomly allocated to either of the two groups .58 Patient in Group A were subjected to local steroid injection and the same number of patient in Group B underwent mini incision technique .
METHODS	All patients of were advised to report to the OPD after one month to determine intervention effectiveness in terms of improvement in at least one grade of pain .
RESULTS	In this study mean age of the patients was 32.8 + / - 5.1 years .
RESULTS	Female gender was in dominance with 99 ( 86.3 % ) cases .
RESULTS	In this study we compared the effectiveness of local steroid injection and mini incision technique in the treatment of carpel tunnel syndrome .
RESULTS	We found out that the steroid injection was effective in 69.0 % cases while mini incision technique was effective in 56.9 % cases .
RESULTS	The difference being statistically insignificant with a p-value of 0.17 .
CONCLUSIONS	The difference in pain after 1 month of the intervention was not statistically significant .

###24434794
OBJECTIVE	The assessment of myocardial fatty acid metabolism impairment by single-photon emission computed tomography ( SPECT ) using ( 123 ) I -- methyliodophenyl-pentadecanoic acid ( BMIPP ) might predict the risk of cardiac death in hemodialysis patients .
OBJECTIVE	We investigated the potential of oral nicorandil to improve myocardial fatty acid metabolism after percutaneous coronary intervention ( PCI ) in this population .
METHODS	We evaluated 128 hemodialysis patients who had obtained coronary revascularization by PCI ( 90 men and 38 women , 66 9 years ) .
METHODS	Participants for the analysis were randomly assigned to either the nicorandil ( n = 63 ) or control group ( n = 65 ) .
METHODS	BMIPP SPECT was performed every year after coronary revascularization by PCI .
METHODS	Uptake on SPECT was graded in 17 segments on a 5-point scale ( 0 , normal ; 4 , absent ) and assessed as BMIPP summed scores ( SS ) .
RESULTS	The incidence of cardiac death was lower ( p = 0.004 ) in the nicorandil group ( 7/63 , 11.1 % ) than in the control group ( 21/65 , 32.3 % ) during a mean follow-up of 2.7 1.4 years .
RESULTS	BMIPP SS reduction rates improved in the nicorandil group compared with the control group from 3 years of administration .
RESULTS	In Kaplan-Meier analyses , free survival rate of cardiac death was higher in patients with a 20 % BMIPP SS reduction rate as compared with those with a < 20 % BMIPP SS reduction rate ( p = 0.0001 ) .
RESULTS	In multiple logistic analysis , oral administration of nicorandil was associated with 20 % reduction rates of BMIPP SS ( odds ratio 2.823 , p = 0.011 ) .
CONCLUSIONS	Long-term oral administration of nicorandil may improve impaired myocardial fatty acid metabolism after coronary revascularization by PCI in hemodialysis patients .

###25037033
BACKGROUND	The immunogenicity and safety of the investigational diphtheria , tetanus , acellular pertussis , hepatitis B , poliomyelitis , Haemophilus influenzae type b ( Hib ) and meningococcal serogroup C ( MenC ) heptavalent combination vaccine were compared with those of licensed control vaccines .
METHODS	In this open , phase II , randomized study ( NCT01090453 ) , 480 infants from Germany , France and Canada received the heptavalent vaccine ( Hepta group ) or hexavalent and monovalent MenC control vaccines ( HexaMenC group ) co-administered with a 13-valent pneumococcal conjugate vaccine at 2 , 4 and 12 months of age .
METHODS	Immunogenicity was measured 1 month after the second primary dose , and before and 1 month after the booster dose .
METHODS	Safety and reactogenicity were also evaluated .
RESULTS	Non-inferiority of immune responses to MenC and Hib induced by 2-dose primary vaccination with the heptavalent vaccine versus control vaccines was demonstrated .
RESULTS	In exploratory analyses , postprimary and postbooster functional antibody geometric mean titers against MenC tended to be lower ( 1119.5 vs. 3200.5 ; 2653.8 vs. 6028.4 ) and antibody geometric mean concentrations against Hib higher ( 1.594 vs. 0.671 g/mL ; 17.678 vs. 13.737 g/mL ) in the Hepta versus the HexaMenC group .
RESULTS	The heptavalent and control vaccines were immunogenic to all other antigens , although immune responses to poliovirus were lower than expected in both groups .
RESULTS	No differences in safety and reactogenicity profiles were detected between groups .
CONCLUSIONS	The heptavalent vaccine induced non-inferior MenC and Hib responses compared with control vaccines .
CONCLUSIONS	Both vaccination regimens , when administered at 2 , 4 and 12 months of age , had comparable safety profiles and were immunogenic to all antigens , with lower-than-expected responses to poliomyelitis .

###24432872
OBJECTIVE	The phase III EINSTEIN DVT and EINSTEIN PE trials demonstrated the potential of oral rivaroxaban for the treatment of deep vein thrombosis ( DVT ) and pulmonary embolism ( PE ) .
OBJECTIVE	The length of initial hospitalization in patients presenting with either symptomatic DVT or PE was assessed using hospitalization records from these trials .
METHODS	Analyses were carried out in the intention-to-treat population , using non-parametric and parametric statistical methods .
RESULTS	Overall , 52 % ( 1781/3434 ) of EINSTEIN DVT patients and 90 % ( 4328/4821 ) of EINSTEIN PE patients were admitted to hospital .
RESULTS	The proportion of hospitalized patients with a length of stay of five or fewer days receiving rivaroxaban was 54 % compared with 31 % for enoxaparin/vitamin K antagonist ( VKA ) in patients with DVT .
RESULTS	For patients with PE , the corresponding values were 45 % and 33 % .
RESULTS	Stays of 6-10 days were observed in 29 % of rivaroxaban-treated patients compared with 45 % of enoxaparin/VKA-treated patients for DVT .
RESULTS	For patients with PE , these values were 39 % and 46 % in the rivaroxaban and enoxaparin/VKA groups , respectively .
RESULTS	Overall , length of stay was significantly shorter in the rivaroxaban group , compared with the enoxaparin/VKA group across all analyses performed ( p < 0.0001 ) .
RESULTS	Across regions , the observed admission rates and length of stay duration varied greatly : Asia had the longest overall hospitalization rates , whereas the lowest rates were reported in North America , Australia and New Zealand .
RESULTS	Nevertheless , a consistent trend was observed : length of hospital stay in patients with DVT or PE receiving rivaroxaban was shorter than , or at least similar to , patients receiving enoxaparin/VKA .
CONCLUSIONS	A single-drug regimen with rivaroxaban may reduce the burden on healthcare systems and patients , and provides effective and well tolerated treatment .
CONCLUSIONS	The studies shared an open-label design that allowed comparison of initial hospitalization , but limitations include the well monitored clinical trial setting in which decisions on admission and discharge could vary from real-world management .

###25076161
BACKGROUND	Identification of cancer or inflammatory bowel disease in the intestinal tract by PET/computed tomography ( CT ) imaging can be hampered by physiological uptake of F-fluorodeoxyglucose ( F-FDG ) in the normal colon .
BACKGROUND	Previous work has localized this F-FDG uptake to the intestinal lumen , predominantly occupied by bacteria .
BACKGROUND	We sought to determine whether pretreatment with an antibiotic could reduce F-FDG uptake in the healthy colon .
METHODS	Thirty patients undergoing restaging PET/CT for nongastrointestinal lymphoma were randomly selected to receive rifaximin 550 mg twice daily for 2 days before their scan ( post-rifaximin ) .
METHODS	Their PET/CT images were compared with those from their prior study ( pre-rifaximin ) .
METHODS	Cecal maximum standard uptake value ( SUVmax ) and overall colonic F-FDG uptake were compared between scans .
METHODS	All PET/CT images were blindly scored by a radiologist .
METHODS	The same comparison of sequential scans was also undertaken in 30 patients who did not receive antibiotics .
RESULTS	Thirty post-rifaximin scans were compared with 30 pre-rifaximin scans in the same patients .
RESULTS	SUVmax in the cecum was significantly lower in the patient 's post-rifaximin scans than in their pre-rifaximin scans ( P = 0.002 ) .
RESULTS	The percentage of scans with greater than grade 1 colonic F-FDG uptake was significantly lower in the post-rifaximin scans than in the pre-rifaximin scans ( P < 0.05 ) .
RESULTS	In contrast , there was no significant difference in the paired sequential scans from control patients , nor a reduction in the percentage of scans with greater than grade 1 colonic F-FDG uptake .
CONCLUSIONS	This pilot study shows that treatment with rifaximin for 2 days before PET/CT scanning can significantly reduce physiological F-FDG uptake in the normal colonic lumen .

###25907174
OBJECTIVE	Bioequivalence and comparability studies are necessary for changing formulations of large-molecule drugs , such as antibody drugs and protein products , and in the development of their biosimilars .
OBJECTIVE	This study is the first application of modeling and simulation ( M&S ) in the design of bioequivalence and comparability studies of erythropoietin as an example of a large-molecule drug .
METHODS	A novel population pharmacokinetic and pharmacodynamic ( PPK/PD ) model was developed for erythropoietin .
METHODS	Based on this PPK/PD model , the probabilities of success of bioequivalence and comparability studies were simulated with various numbers of subjects and samples .
RESULTS	The simulation indicated that the minimum numbers of subjects and samples required to satisfy the criteria for bioequivalence and comparability studies were as follows : fewest for the area under the serum concentration-time curve , more for the area under the efficacy-time curve , and most for the maximum serum concentration of erythropoietin .
CONCLUSIONS	These results suggested that M&S could be successfully applied in the design of bioequivalence and comparability studies of large-molecule drugs .

###25915628
BACKGROUND	A previous multicenter clinical trial of a needle-based fractional radiofrequency ( FRF ) treatment for facial and neck rhytides and laxity counterintuitively demonstrated a mean target temperature and treatment duration of 69.5 C and 4.9 seconds for subjects with lesser improvement and 67 C and 4.2 seconds for greater improvement .
OBJECTIVE	To determine optimal temperature and duration settings for maximal clinical results in rhytides and laxity from a single FRF treatment of the face and neck .
METHODS	A randomized , blinded , 3-arm clinical evaluation of FRF at a series of temperatures from 52-57 C to 67 C. Three blinded plastic surgeons and dermatologists scored rhytides using the Fitzpatrick Wrinkle Assessment Scale and laxity using the Alexiades Laxity Assessment Scale at 1 , 3 , and 6 months .
RESULTS	Blinded grading showed optimal improvement at 67 C and 3 seconds and decreased efficacy below 67 C , with mean rhytide reductions of 40 , 29 , and 25 % and mean laxity reductions of 34 , 36 , and 25 % in Arms 3 ( 67 C ) , 2 ( 62 C ) , and 1 ( 52 C-57 C ) , respectively .
RESULTS	A 100 % response rate was observed for all subjects treated at 62 C to 67 C target temperature .
CONCLUSIONS	The optimal target dermal temperature for facial and neck rhytide and laxity treatment is 67 C and duration of 3 to 4 seconds with a 100 % response rate after a single FRF treatment .

###24238118
BACKGROUND	To reduce the spread of antibiotic resistance , there is a pressing need for worldwide implementation of effective interventions to promote more prudent prescribing of antibiotics for acute LRTI .
BACKGROUND	This study is a process analysis of the GRACE/INTRO trial of a multifactorial intervention that reduced antibiotic prescribing for acute LRTI in six European countries .
BACKGROUND	The aim was to understand how the interventions were implemented and to examine effects of the interventions on general practitioners ' ( GPs ' ) and patients ' attitudes .
METHODS	GPs were cluster randomised to one of three intervention groups or a control group .
METHODS	The intervention groups received web-based training in either use of the C-reactive protein ( CRP ) test , communication skills and use of a patient booklet , or training in both .
METHODS	GP attitudes were measured before and after the intervention using constructs from the Theory of Planned Behaviour and a Website Satisfaction Questionnaire .
METHODS	Effects of the interventions on patients were assessed by a post-intervention questionnaire assessing patient enablement , satisfaction with the consultation , and beliefs about the risks and need for antibiotics .
RESULTS	GPs in all countries and intervention groups had very positive perceptions of the intervention and the web-based training , and felt that taking part had helped them to reduce prescribing .
RESULTS	All GPs perceived reducing prescribing as more important and less risky following the intervention , and GPs in the communication groups reported increased confidence to reduce prescribing .
RESULTS	Patients in the communication groups who received the booklet reported the highest levels of enablement and satisfaction and had greater awareness that antibiotics could be unnecessary and harmful .
CONCLUSIONS	Our findings suggest that the interventions should be broadly acceptable to both GPs and patients , as well as feasible to roll out more widely across Europe .
CONCLUSIONS	There are also some indications that they could help to engender changes in GP and patient attitudes that will be helpful in the longer-term , such as increased awareness of the potential disadvantages of antibiotics and increased confidence to manage LRTI without them .
CONCLUSIONS	Given the positive effects of the booklet on patient beliefs and attitudes , it seems logical to extend the use of the patient booklet to all patients .

###24915612
OBJECTIVE	Durable post-treatment response is uncommon in chronic hepatitis B ( CHB ) patients on nucleos ( t ) ide analogue therapy .
OBJECTIVE	Response , response predictors and safety were assessed in patients who switched from long-term entecavir ( ETV ) to peginterferon alfa-2a .
METHODS	Hepatitis B e antigen ( HBeAg ) - positive CHB patients who had received ETV for 9-36 months , with HBeAg < 100 PEIU/ml and HBV DNA 1000 copies/ml , were randomised 1:1 to receive peginterferon alfa-2a 180 g/week or ETV 0.5 mg/day for 48 weeks .
METHODS	The primary endpoint was HBeAg seroconversion at week 48 ( ClinicalTrials.gov : NCT00940485 ) .
RESULTS	200 patients were randomised ; 197 received 1 study drug dose .
RESULTS	Five patients who were anti-HBe-positive at baseline were excluded from the modified intention-to-treat population ( peginterferon alfa-2a , n = 94 ; ETV , n = 98 ) .
RESULTS	Patients who switched to peginterferon alfa-2a achieved higher week 48 HBeAg seroconversion rates vs. those who continued ETV ( 14.9 % vs. 6.1 % ; p = 0.0467 ) .
RESULTS	Only patients receiving peginterferon alfa-2a achieved HBsAg loss ( 8.5 % ) .
RESULTS	Among peginterferon alfa-2a-treated patients with HBeAg loss and HBsAg < 1500 IU/ml at randomisation , 33.3 % and 22.2 % achieved HBeAg seroconversion and HBsAg loss , respectively .
RESULTS	Early on-treatment HBsAg decline predicted response at week 48 ; highest rates were observed in patients with week 12 HBsAg < 200 IU/ml ( HBeAg seroconversion , 66.7 % ; HBsAg loss , 77.8 % ) .
RESULTS	Alanine aminotransferase elevations were not associated with viral rebound ( n = 38 ) .
RESULTS	Peginterferon alfa-2a was well-tolerated .
CONCLUSIONS	For patients who achieve virological suppression with ETV , switching to a finite course of peginterferon alfa-2a significantly increases rates of HBeAg seroconversion and HBsAg loss .
CONCLUSIONS	A response-guided approach may identify patients with the greatest chance of success .

###25554551
OBJECTIVE	To estimate effect sizes for a trial to compare preventable pulmonary complications ( PPCs ) , turning-related adverse events , mechanical ventilation duration , intensive care unit ( ICU ) length of stay , and ICU mortality between patients randomized to 2-hourly manual or continuous automated lateral rotation .
METHODS	Randomized controlled trial pilot study with 15 patients selected randomly from eligible medical-surgical ICU patients from 2 tertiary hospitals and assigned randomly to the manual-turn or automated-turn protocol for up to 7 consecutive days .
METHODS	A radiologist blinded to group and site assessed serial chest radiographs for PPCs .
METHODS	Repeated-measures analysis with linear mixed models was used to estimate change in PPC score , and Wilcoxon rank sum or Fisher exact test was used to compare group differences in the secondary outcomes .
RESULTS	Of 16 patients enrolled , 12 ( 75 % ) completed the study .
RESULTS	Data from 15 patients , 7 manual turn and 8 automated turn , were analyzed .
RESULTS	Between-group differences in PPC incidence ( 67 % overall ) , change in PPC score ( = 0.15 , manual turn and = -0.44 , automated turn ) , and secondary outcomes were not significant ( P > .05 ) .
RESULTS	Standardized effect sizes were small to moderate for the outcome variables .
RESULTS	A sample size of 54 patients would be needed to detect statistically significant between-group differences in PPC over time .
CONCLUSIONS	The incidence of PPCs in adult patients receiving mechanical ventilation in a medical-surgical ICU was high .
CONCLUSIONS	Automated turning decreased PPCs with time but had little effect on secondary outcomes .
CONCLUSIONS	Safety outcomes were not substantially different between groups .
CONCLUSIONS	A modest efficacy effect supported reduced PPCs with automated turning to the lateral position .

###25464675
BACKGROUND	There are so many studies associating blood pressure in children and adolescents with body fatness i.e. stating that high body fat is associated with high blood pressure in children and adolescents .
BACKGROUND	The purpose of this study was to determine that which portion of the body mass index , fat or fat free mass index is more influencing the blood pressure in Gujarati Indian adolescents .
METHODS	733 schoolchildren of 10-18 years of both genders were chosen for this study .
METHODS	The body fat percentage and blood pressure were measured and on the basis of body mass and fat mass , fat free mass index and various other indices were calculated .
METHODS	The association of fat mass index and fat free mass index with blood pressure was computed using correlations .
RESULTS	The relationship of BMI with mean blood pressure of boys ( R = .326 ) was more strong than that in girls ( R = .149 ) .
RESULTS	The blood pressure was having more strong positive correlation with lean body mass index than that with fat mass index in all subjects ( R = 0.230 versus R = 0.184 ) , boys ( R = 0.285 versus R = 0.242 ) , & girls ( R = 0.179 versus R = -0.081 ) .
CONCLUSIONS	Fat free mass index has more strong association with blood pressure than fat mass index in the adolescent population irrespective of gender .
CONCLUSIONS	However as far as prevention of hypertension is concerned , reducing body fat ( rather than only body weight ) may remain an important measure to prevent hypertension as body fat mass is reducible while lean body mass may not be reducible and , in long term , obesity itself can lead to hypertension by various mechanisms .

###25359007
BACKGROUND	Forming ` habit ' - defined as a learned process that generates automatic responses to contextual cues - has been suggested as a mechanism for behaviour maintenance , but few studies have applied habit theory to behaviour change .
BACKGROUND	This study used process evaluation data , taken from a randomised controlled trial of a healthy child-feeding intervention for parents previously shown to be effective , to explore the applicability to dietary behaviour change of predictions and recommendations drawn from habit theory .
BACKGROUND	The intervention supported parents in pursuing child-feeding habit goals in three domains ( giving fruit and vegetables , water , healthy snacks ) , over four fortnightly home visits .
BACKGROUND	We explored whether ( a ) the habit-formation model was acceptable to participants , ( b ) better-specified habit-formation goals yielded greater habit gains , and ( c ) habit gains were sustained ( d ) even when subsequent , new habit goals were pursued .
METHODS	Qualitative and quantitative data were taken from 57 parents randomised to the intervention arm , and so analyses presented here used a pre-post intervention design .
METHODS	Thematic analysis of post-intervention qualitative interviews evaluated acceptability , and self-reported habit goals were content-analysed .
METHODS	ANOVAs explored changes in habit strength , recorded at home visits and one - and two-month follow-ups , across time and goals .
RESULTS	Participants understood and engaged positively with the habit-formation approach .
RESULTS	Although many seemingly poorly-specified habit goals were set , goal characteristics had minimal impact on habit strength , which were achieved within two weeks for all behaviours ( p 's < .001 ) , and were maintained or had increased further by the final follow-up .
CONCLUSIONS	The habit-formation model appears to be an acceptable and fruitful basis for dietary behaviour change .

###24470392
OBJECTIVE	N-acetyltransferase 2 ( NAT2 ) is involved in the metabolism of various environmental substances , both with and without carcinogenic potential .
OBJECTIVE	Alcoholic and nonalcoholic caffeine-rich beverages may be associated with markers of inflammation .
OBJECTIVE	Systemic lupus erythematosus ( SLE ) is a chronic , multifaceted inflammatory disease .
OBJECTIVE	We investigated the effects of alcoholic and nonalcoholic caffeine-rich beverages on risk of SLE and determined whether the effects were modified by NAT2 status .
METHODS	The NAT2 polymorphism was genotyped in 152 SLE cases and 427 healthy controls , all women and Japanese .
METHODS	We assessed effect modification by testing an interaction term for the NAT2 polymorphism and consumption of beverages .
RESULTS	Consumption of black tea ( odds ratio [ OR ] 1.88 , 95 % confidence interval [ 95 % CI ] 1.03-3 .41 ) and coffee ( OR 1.57 , 95 % CI 0.95-2 .61 ) , but not green tea , was associated with an increased risk of SLE , while alcohol use ( OR 0.33 , 95 % CI 0.20-0 .55 ) was associated with a decreased risk of SLE .
RESULTS	There were significant interactions between the NAT2 polymorphism and either alcohol use ( Pinteraction = 0.026 ) or consumption of black tea ( Pinteraction = 0.048 ) .
CONCLUSIONS	The NAT2 polymorphism significantly modified the effects of alcohol use and black tea consumption on SLE , emphasizing the importance of incorporating genetic and metabolic information in studies on management of SLE .
CONCLUSIONS	Additional studies are warranted to confirm the findings suggested in this study .

###24458508
OBJECTIVE	To examine the effects of 12 weeks of periodized resistance training ( RT ) with and without combined creatine and whey protein supplementation on changes in body composition , muscular strength , and functional performance .
METHODS	Twenty-two male volunteers ( 68.1 6.1 years ) were randomly assigned to one of three groups : RT plus supplementation ( RTS , n = 7 ) ; RT only ( RT , n = 7 ) ; or control ( C , n = 8 ) .
METHODS	RTS consumed 0.3 g/kg/day of creatine for 5 days followed by 0.07 g/kg/day .
METHODS	RTS also consumed one 35 g liquid protein ready-to-drink daily .
METHODS	RT and RTS trained 3 days/week .
RESULTS	Following 12 weeks of training , there were no significant differences in the main measured outcome variables between RT and RTS .
RESULTS	RTS increased relative ( % change ) lean body mass ( LBM , 3.3 3.1 % ) compared with C ( p = 0.01 ) .
RESULTS	Compared to baseline , RT increased LBM at week 6 ( 60.2 8.3 to 61.6 9.4 kg ; p < 0.05 ) , and decreased fat mass ( 20.8 4.2 to 19.0 3.9 kg ; p = 0.05 ) and percentage body fat at week 12 ( 25.7 3.8 to 23.8 4.0 % ; p = 0.05 ) ; RTS increased LBM at week 6 ( p < 0.01 ) and week 12 ( 56.4 4.3 to 58.2 3.4 kg ; p < 0.01 ) , and decreased percentage body fat at week 12 ( 23.9 4.4 to 22.0 4.4 % ; p < 0.01 ) .
RESULTS	In addition , compared to C , relative bench press 1-RM increased for RTS ( 72.4 62.2 % ; p < 0.01 ) and RT ( 50.1 21.5 % ; p = 0.05 ) ; relative leg press 1-RM increased for RTS ( 129.6 39.4 % ; p < 0.0001 ) and RT ( 112.9 22.7 % ; p < 0.0001 ) ; RTS increased relative Margaria stair-climbing power ( 38.3 30.4 % ; p < 0.05 ) ; and , relative 400-m walk time decreased for RT ( -11 9.2 % ; p < 0.05 ) and RTS ( -9.6 9.4 % ; p = 0.05 ) .
RESULTS	RT increased estimated VO2Max at week 6 ( p < 0.01 ) and 12 ( 34.6 1.9 to 36.4 2.7 ml/kg/min ; p = 0.01 ) compared to baseline .
RESULTS	Lastly , RTS increased estimated VO2Max at week 12 ( 36.3 2.7 to 37.5 3.3 ml/kg/min ; p = 0.05 ) compared to baseline .
CONCLUSIONS	Creatine and whey protein supplementation may not provide additional benefits in older adults performing periodized RT to augment muscular and functional performance .

###24468539
OBJECTIVE	Our previous study found that cortical gray matter ( cGM ) volume predicted vascular cognitive impairment independent of age-related white matter changes ( WMC ) .
OBJECTIVE	We aimed to investigate predictors for cGM volume in ischemic stroke patients with confluent WMC .
METHODS	One-hundred post-stroke patients with confluent WMC were recruited into the study .
METHODS	All volumetric measures were standardized by intracranial volume as volume ratio .
METHODS	Univariate analyses and multivariate linear regression models were used to test relationship of cGM volume with basic demography , vascular risk factors , APOE status , WMC volume ( periventricular and deep WMC ) , infarct measures ( volume , number and location ) and microbleed ( number , presence and location ) .
RESULTS	After controlling for significant variables in the univariate analyses , multivariate linear regression models found that old age ( = -0.288 , p = 0.001 ) , low triglyceride ( = 0.194 , p = 0.027 ) , periventricular WMC ( PVWMC ) ( = -0.392 , p < 0.001 ) and presence of thalamic microbleed ( = -0.197 , p = 0.041 ) were independently predictive of less cGM volume ratio .
CONCLUSIONS	Age , PVWMC and left thalamic microbleed predict less cGM volume .

###24223806
BACKGROUND	Alcohol consumption of college students has a fluctuating nature , which might impact the measurement of intervention effects .
BACKGROUND	By using 25 follow-up time-points , this study tested whether intervention effects are robust or might vary over time .
METHODS	Data were used from a two-arm parallel group randomized controlled trial applying ecological momentary assessment ( EMA ) with 30 data time-points in total .
METHODS	Students between 18 and 24 years old who reported heavy drinking in the past six months and who were ready to change their alcohol consumption were randomly assigned to the experimental ( n = 456 : web-based brief alcohol intervention ) and control condition ( n = 451 : no intervention ) .
METHODS	Outcome measures were weekly alcohol consumption , frequency of binge drinking , and heavy drinking status .
RESULTS	According to the intention-to-treat principle , regression analyses revealed that intervention effects on alcohol consumption varied when exploring multiple follow-up time-points .
RESULTS	Intervention effects were found for a ) weekly alcohol consumption at 1 , 2 , 3 , 4 , and 7 weeks follow-up , b ) frequency of binge drinking at 1 , 2 , 7 , and 12 weeks follow-up , and c ) heavy drinking status at 1 , 2 , 7 , and 16 weeks follow-up .
CONCLUSIONS	This research showed that the commonly used one and six month follow-up time-points are relatively arbitrary and not using EMA might bring forth erroneous conclusions on the effectiveness of interventions .
CONCLUSIONS	Therefore , future trials in alcohol prevention research and beyond are encouraged to apply EMA when assessing outcome measures and intervention effectiveness .
BACKGROUND	Netherlands Trial Register NTR2665 .

###24634003
BACKGROUND	Using phase 3 trial data for sunitinib versus interferon ( IFN ) - in treatment-naive patients with metastatic renal cell carcinoma , retrospective analyses characterized sunitinib-associated fatigue and its impact on patient-reported health-related quality of life ( HRQoL ) .
METHODS	Patients received sunitinib at a dose of 50 mg/day on a schedule of 4 weeks on/2 weeks off ( 375 patients ) or IFN - at a dose of 9 MU subcutaneously 3 times per week ( 360 patients ) .
METHODS	HRQoL was self-assessed using the Functional Assessment of Cancer Therapy-Kidney Symptom Index-15-item ( FKSI-15 ) questionnaire , with fatigue assessed using its Disease-Related Symptoms subscale .
METHODS	Fatigue was also assessed by providers using Common Terminology Criteria for Adverse Events ( CTCAE ) .
METHODS	A repeated-measures model ( M1 ) and random intercept-slope model ( M2 ) characterized sunitinib-associated fatigue over time .
METHODS	Another repeated-measures model examined the relationship between HRQoL scores and CTCAE fatigue grade .
RESULTS	M1 demonstrated that the initial increase in patient-reported fatigue with sunitinib was worst during cycle 1 , with mean values numerically better at subsequent cycles ; most pairwise comparisons of consecutive CTCAE fatigue cycle means were not found to be statistically significant .
RESULTS	M2 demonstrated that the overall trend ( slope ) for patient-reported and CTCAE fatigue with sunitinib was not statistically different from 0 .
RESULTS	The relationship between most HRQoL scores and CTCAE fatigue was close to linear regardless of treatment , with lower scores ( worse HRQoL ) corresponding to higher fatigue grade .
RESULTS	The majority of HRQoL scores were better with sunitinib versus IFN - for the same CTCAE fatigue grade .
CONCLUSIONS	Patients reported worse fatigue during the first sunitinib cycle .
CONCLUSIONS	However , in subsequent consecutive cycles , less fatigue was reported with no statistically significant worsening .
CONCLUSIONS	CTCAE fatigue assessment may not fully capture patient treatment experience .

###24677110
OBJECTIVE	Endogenous anterior uveitis ( AU ) , when untreated , may lead to vision loss .
OBJECTIVE	This study compared the safety and efficacy of difluprednate versus prednisolone acetate for the treatment of this condition .
METHODS	This phase III , double-masked , noninferiority study randomized patients with mild to moderate endogenous AU to receive difluprednate 0.05 % ( n = 56 ) four times daily , alternating with vehicle four times daily , or prednisolone acetate 1 % ( n = 54 ) eight times daily .
METHODS	The 14-day treatment period was followed by a 14-day dose-tapering period and a 14-day observation period .
METHODS	The primary efficacy end point was change in anterior chamber cell grade ( range , 0 for 1 cell to 4 for > 50 cells ) from baseline to day 14 .
RESULTS	At day 14 , the mean change in anterior chamber cell grade with difluprednate was noninferior to that with prednisolone acetate ( -2.2 vs. -2.0 , P = 0.16 ) .
RESULTS	The proportions of difluprednate-treated patients versus prednisolone acetate-treated patients demonstrating complete clearing of anterior chamber cells at day 3 were 13.0 % vs. 2.1 % ( P = 0.046 ) and at day 21 were 73.9 % vs. 63.8 % ( P = 0.013 ) .
RESULTS	A significant between-group difference in the mean IOP increase was seen at day 3 ( 2.5 mm Hg for difluprednate-treated patients and 0.1 mm Hg for prednisolone acetate-treated patients , P = 0.0013 ) but not at other time points .
RESULTS	The mean IOP values in both groups remained less than 21 mm Hg throughout the study .
CONCLUSIONS	Difluprednate 0.05 % four times daily is well tolerated and is noninferior to prednisolone acetate 1 % eight times daily for the treatment of endogenous AU .
CONCLUSIONS	( ClinicalTrials.gov number , NCT01201798 . )

###25112083
OBJECTIVE	To compare the differences in the efficacy on speech and swallowing dysfunction of medulla oblongata palsy ( MOP ) after brainstem infarction between electroacupuncture at eight-neck-occiput points and routine acupoints .
METHODS	Seventy-two patients were randomized into a neck-occiput points group and a meridian points group , 36 cases in each one .
METHODS	In the neck-occiput points group , the eight-neck-occiput points ( Neck 1-4 points , Occiput 1-4 points ) were selected .
METHODS	In the meridian points group , Lianquan ( CV 23 ) , Futu ( LI 18 ) , Tongli ( HT 5 ) , Hegu ( LI 4 ) and the others were selected .
METHODS	Electroacupuncture was used in the two groups , dense-dispersion wave , retaining for 30 min .
METHODS	The treatment was given once a day , 5 treatments a week .
METHODS	Totally , 4 weeks were required .
METHODS	The symptom scores of speech and swallowing dysfunction were observed before and after treatment in the two groups .
METHODS	The efficacy was compared between the two groups .
RESULTS	The scores of speech and swallowing dysfunction were improved significantly after treatment in the two groups ( P < 0.05 , P < 0.01 ) .
RESULTS	The results in the neck-occiput points group were better than those in the meridian points group ( both P < 0.01 ) .
RESULTS	The curative rate of speech dysfunction was 30.6 % ( 11/36 ) and that of swallowing dysfunction was 22.2 % ( 8 / 36 ) in the neck-occiput points group , which were better than 11.1 % ( 4/36 ) and 5.6 % ( 2/36 ) in the meridian points group , respectively .
RESULTS	The differences were significant in comparison of the two groups ( P < 0.01 , P < 0.05 ) .
CONCLUSIONS	Electroacupuncture at eight-neck-occiput points achieves a better efficacy on speech and swallowing dysfunction of MOP after brainstem infarction as compared with the routine acupoints .
CONCLUSIONS	This therapy is characterized as more accurate point localization and safer operation .

###24698702
BACKGROUND	Wet-wrap treatment ( WWT ) has been advocated as a relatively effective treatment in children with severe atopic dermatitis ( AD ) .
BACKGROUND	WWT often serves as crisis intervention for AD .
OBJECTIVE	We sought to evaluate the use of WWT with diluted corticosteroids in comparison with emollient in children with severe AD during 4 weeks in a proactive schedule during which the frequency of corticosteroid applications was tapered .
METHODS	A randomized , double-blind , placebo-controlled study was performed in children aged 6 months to 10 years with severe AD ( objective SCORAD at least 40 5 ) , comparing WWT with diluted corticosteroids ( 1:3 mometasone furoate 0.1 % ointment and for the face 1:19 mometasone furoate 0.1 % ointment under a mask ) with emollient ( petrolatum 20 % in cetomacrogol cream ) .
METHODS	The primary outcome was improvement of the objective SCORAD ; secondary outcomes included Patient-Oriented Eczema Measure and quality-of-life index .
RESULTS	WWT with diluted corticosteroids acted faster and was more efficacious than WWT with emollients .
RESULTS	Best results were obtained in age groups 6 to 9 years and 0 to 3 years .
RESULTS	The difference in efficacy evaluated by objective SCORAD was significant at all measuring points .
RESULTS	This also applied to the quality-of-life index .
CONCLUSIONS	The study group was relatively small .
CONCLUSIONS	WWT for severe AD is an effective therapy option for at least a period of 4 weeks .

###25761503
BACKGROUND	The common variants in the fat mass and obesity-associated ( FTO ) gene have been associated with obesity and insulin resistance .
BACKGROUND	Recently , studies also linked FTO variants with macronutrient intakes .
OBJECTIVE	We aimed to investigate whether diet interventions varying in macronutrients modified the effects of FTO genotypes on changes in insulin resistance .
METHODS	We genotyped FTO variants rs1558902 and rs9939609 and measured insulin resistance in fasting plasma samples at baseline and at 6-mo and 2-y visits in 743 overweight or obese adults ( aged 30-70 y , 60 % women ) from a randomized weight-loss dietary interventional trial , the Preventing Overweight Using Novel Dietary Strategies ( POUNDS LOST ) trial .
METHODS	We assessed interactions between FTO variants and intakes of dietary fat and protein in relation to change in body weight and insulin resistance using generalized estimating equation models .
RESULTS	We found significant interactions between rs1558902 and dietary fat on changes in homeostasis model assessment of insulin resistance ( HOMA-IR ) and insulin ( P = 0.003 and 0.004 , respectively ) .
RESULTS	Each risk allele ( A ) of rs1558902 showed a trend to be related to a 0.05-unit less reduction in both log ( insulin ) and log ( HOMA-IR ) among the participants assigned to low-fat diets ( both P = 0.06 ) , but this was not significantly related to reduction in those assigned to high-fat diets ( both P > 0.1 ) during the 2-y period of intervention .
RESULTS	Our data showed that the association between rs9939609 and changes in insulin resistance was not modified by diet macronutrient intakes .
CONCLUSIONS	Our results show that carriers of the risk alleles of rs1558902 benefit differently in improving insulin sensitivity by consuming high-fat weight-loss diets rather than low-fat diets .
CONCLUSIONS	Still , given our data , we acknowledge it is difficult to determine whether fat or carbohydrate contributed to the observed associations .

###25641452
BACKGROUND	The ideal bioptic strategy for CaP detection is still to be completely defined .
BACKGROUND	The aim of our study is to compare transperineal ( TP ) and transrectal ( TR ) approaches , in a 14-core initial prostate biopsy for CaP detection .
METHODS	A prospective controlled study was conducted enrolling 108 consecutive patients with a PSA level greater than 4 ng/mL and/or an abnormal DRE .
METHODS	TR versus TP 14-core initial prostatic biopsies were performed on 54 and 54 patients , respectively , with a randomisation ratio of 1:1 .
RESULTS	The cancer detection rates were 46.29 ( 25 out of 54 patients ) , and 44.44 % ( 24 out of 54 patients ) , respectively , using the TR or the TP approach ( p = 0.846 ) .
RESULTS	The overall cancer core rate was significantly higher when the TP approach was used : 21.43 % ( 162 out of 756 cores ) and 16.79 % ( 127 out of 756 cores ) , with the TP and the TR approach , respectively ( p = 0.022 ) .
RESULTS	The cores were significantly longer performing TP approach : at the site `` 1 '' ( 14.92 versus 12.97 mm , p = 0.02 ) ; at `` 5 '' ( 15.53 versus 13.69 mm , p = 0.037 ) ; at `` 7 '' ( 15.06 versus 12.86 mm , p = 0.001 ) ; at `` 9 '' ( 14.92 versus 13.38 mm , p = 0.038 ) ; at `` 11 '' ( 16.32 versus 12.31 mm , p = 0.0001 ) ; at `` 12 '' ( 15.14 versus 12.19 mm , p = 0.0001 ) ; at `` 13 '' ( 17.49 versus 13.98 mm , p = 0.0001 ) ; at `` 14 '' ( 16.77 versus 13.36 mm , p = 0.0001 ) .
RESULTS	As to the biopsy related pain , the mean pain level perceived by patients during the TR approach was 1.56 1.73 versus 1.42 1.37 registered during TP approach ( p = 0.591 ) .
CONCLUSIONS	No significant differences were found in cancer detection rate , cancer core rate between TP and TR approaches for prostatic biopsy .
CONCLUSIONS	Even in terms of complication rate or pain level , it can not be concluded that one procedure is superior to the other one .
CONCLUSIONS	Apparently , strictly following our protocol , TP approach seems to offer a better sampling at the level of the apex and the TZ , however without adding any significant advantage in terms of overall cancer detection rate .

###25593053
BACKGROUND	The role of patient age in the efficacy of mesenchymal stem cell ( MSC ) therapy in ischemic cardiomyopathy ( ICM ) is controversial .
OBJECTIVE	This study sought to determine whether the therapeutic effect of culture-expanded MSCs persists , even in older subjects .
METHODS	Patients with ICM who received MSCs via transendocardial stem cell injection ( TESI ) as part of the TAC-HFT ( Transendocardial Autologous Cells in Ischemic Heart Failure ) ( n = 19 ) and POSEIDON ( Percutaneous Stem Cell Injection Delivery Effects on Neomyogenesis ) ( n = 30 ) clinical trials were divided into 2 age groups : younger than 60 and 60 years of age and older .
METHODS	Functional capacity was measured by 6-min walk distance ( 6MWD ) and quality of life using the Minnesota Living With Heart Failure Questionnaire ( MLHFQ ) score , measured at baseline , 6 months , and 1 year post-TESI .
METHODS	Various cardiac imaging parameters , including absolute scar size , were compared at baseline and 1 year post-TESI .
RESULTS	The mean 6MWD was similar at baseline and increased at 1 year post-TESI in both groups : 48.5 14.6 m ( p = 0.001 ) for the younger and 35.9 18.3 m ( p = 0.038 ) for the older participants ( p = NS between groups ) .
RESULTS	The older group exhibited a significant reduction in MLHFQ score ( -7.04 3.54 ; p = 0.022 ) , whereas the younger than 60 age group had a borderline significant reduction ( -11.22 5.24 ; p = 0.058 ) from baseline ( p = NS between groups ) .
RESULTS	Although there were significant reductions in absolute scar size from baseline to 1 year post-TESI , the effect did not differ by age .
CONCLUSIONS	MSC therapy with TESI in ICM patients improves 6MWD and MLHFQ score and reduces myocardial infarction size .
CONCLUSIONS	Importantly , older individuals did not have an impaired response to MSC therapy .

###25661136
OBJECTIVE	To compare the intraoperative pain , anxiety , undesired movement , and cooperation between patients receiving oral diazepam or intravenous ( IV ) midazolam for conscious sedation during cataract surgery under topical anesthesia .
METHODS	Ambulatory surgical center , Honolulu , Hawaii , USA .
METHODS	Prospective randomized controlled trial .
METHODS	Patients having first-time cataract extraction with topical anesthesia were randomized to receive sedation with oral diazepam 30 minutes before surgery or IV midazolam immediately preceding surgery .
METHODS	The outcomes of intraoperative pain , anxiety , undesired movement , and poor cooperation were observed by the surgeon and recorded during surgery .
RESULTS	One hundred fifty-six cataract surgeries were included , 83 in the IV midazolam group and 73 in the oral diazepam group .
RESULTS	Twenty-four patients ( 29 % ) in the IV group and 7 patients ( 10 % ) in the oral group showed undesired movement ( P < .02 ) .
RESULTS	Seven patients ( 8 % ) in the IV group and 2 patients ( 3 % ) in the oral group showed poor cooperation ( P > .05 ) .
RESULTS	Fifteen patients ( 18 % ) in the IV group and 9 patients ( 12 % ) in the oral group had anxiety ( P > .05 ) .
RESULTS	Three patients ( 4 % ) in the IV group and 3 patients ( 4 % ) in the oral group experienced pain ( P > .05 ) .
CONCLUSIONS	Fewer patients receiving oral diazepam 30 minutes before cataract surgery than patients receiving IV midazolam immediately preceding surgery showed undesired movement during surgery .
CONCLUSIONS	There was no statistically significant difference in the number of patients showing poor cooperation or experiencing pain or anxiety between the 2 groups .
BACKGROUND	No author has a financial or proprietary interest in any material or method mentioned .

###24892114
OBJECTIVE	To compare the efficacy of 1-stage versus 2-stage lateral maxillary sinus lift procedures .
METHODS	Sixty partially edentulous patients requiring 1 to 3 implants and having 1 to 3 mm of residual bone height and at least 5 mm bone width below the maxillary sinus , as measured on CT scans were selected .
METHODS	They were randomised according to a parallel group study design into two equal arms to receive either a 1-stage lateral window sinus lift with simultaneous implant placement or a 2-stage procedure with implant placement delayed by 4 months , using a bone substitute in three different centres .
METHODS	Implants were submerged for 4 months , loaded with reinforced provisional prostheses , which were replaced , after 4 months , by definitive prostheses .
METHODS	Outcome measures , assessed by masked assessors , were : augmentation procedure failures ; prosthesis failures and implant failures ; complications ; and marginal peri-implant bone level changes .
METHODS	Patients were followed up to 1 year after loading .
METHODS	Only data of implants placed in 1 to 3 mm of bone height were reported .
RESULTS	Two patients dropped out from the 1-stage group and none from the 2-stage group .
RESULTS	No sinus lift procedure failed in the 1-stage group but one failed in the 2-stage group , the difference being not statistically significant ( P = 1.00 ) .
RESULTS	Two prostheses failed or could not be placed in the planned time in the 1-stage group and one in the 2-stage group , the difference being not statistically significant ( P = 0.51 ) .
RESULTS	Three implants failed in three patients of the 1-stage group , versus one implant in the 2-stage group , the difference being not statistically significant ( P = 0.28 ) .
RESULTS	Two complications occurred in the 1-stage group and one in the 2-stage group , the difference being not statistically significant ( P = 0.61 ) .
RESULTS	One year after loading , 1-stage treated patients lost an average of -1.01 mm ( SD : 0.56 ) of peri-implant bone and 2-stage sites about -0.93 mm ( SD : 0.40 ) .
RESULTS	There were no statistically significant differences in bone level change between groups 1 year after loading ( -0.08 mm 95 % CI : -0.33 to 0.18 P = 0.56 ) .
CONCLUSIONS	No statistically significant differences were observed between implants placed according to 1 - or 2-stage sinus lift procedures .
CONCLUSIONS	However this study may suggest that in patients having residual bone height between 1 to 3 mm below the maxillary sinus , there might be a slightly higher risk for implant failures when performing a 1-stage lateral sinus lift procedure .

###24580114
OBJECTIVE	The main aim was to investigate the effectiveness of a novel internal teat sealant ( ITS ) formulation containing bismuth subnitrate and the antiseptic chlorhexidine , in adult cows ( Trial A ) and nulliparous heifers ( Trial B ) , to reduce the incidence of new intramammary infection ( IMI ) between treatment and calving and reduce the prevalence of IMI within 6 days following calving .
METHODS	In Trial A dairy cows ( n = 326 ) without history of clinical mastitis and with a maximum composite milk somatic cell count < 200,000 cells/mL during the current lactation were enrolled from three spring-calving mainly pasture-based herds immediately following the final milking .
METHODS	In Trial B all heifers ( n = 166 ) were enrolled from two herds approximately 3 weeks before the start of calving .
METHODS	Glands were randomly assigned to controls or treatment with ITS , and mammary secretion samples were taken from all glands prior to treatment , and on two occasions 0-4 and 3-6 days post-calving to determine the incidence of new IMI and the prevalence of IMI immediately post-calving .
METHODS	Additionally , cows in Trial A were monitored for cases of clinical mastitis ( CM ) in the non-lactating period and animals in both trials were monitored for cases of CM within 30 days of calving .
RESULTS	The ITS reduced the estimated incidence of new IMI with both major and any pathogens compared to control glands in cows ( 6.2 vs. 14.2 % and 14.7 vs. 32.8 % , respectively ) and in heifers ( 3.0 vs. 13.1 % and 13.4 vs. 25.3 % , respectively ) ( p < 0.001 ) .
RESULTS	The ITS reduced the estimated prevalence of a major or any pathogen compared to untreated controls at both 0-4 and 3-6 days post-calving , in both cows and heifers .
RESULTS	Additionally , the ITS reduced the incidence of CM in the non-lactating period in cows ( -1.0 % , p = 0.01 ) and in the 30 days following calving in heifers ( -2.0 % , p = 0.06 ) , and tended to reduce the estimated incidence of CM in cows post-calving ( -1.7 % , p = 0.10 ) .
CONCLUSIONS	The novel ITS reduced the incidence of new IMI , and the prevalence of IMI at calving in both adult cows and heifers , and reduced the incidence of CM in the non-lactating period of cows and in the first 30 days after calving in heifers .
CONCLUSIONS	The results of these trials demonstrate the efficacy of a novel ITS for the control of mastitis in likely uninfected dairy cows over the non-lactating period and in heifers in late pregnancy .

###24778046
BACKGROUND	We report the results of a phase II trial of adding the anti-ascular endothelial growth factor ( VEGF ) bevacizumab to gemcitabine neoadjuvant chemotherapy for patients with borderline and unresectable non-metastatic pancreatic cancer .
METHODS	Patients were assigned to one of the two treatment arms .
METHODS	Both groups received 1,000 mg/m ( 2 ) gemcitabine on days 1 , 8 , and 15 of a 4-week cycle for a total of four cycles .
METHODS	Group 1 received 5 mg/kg bevacizumab for six weeks ( three doses ) , every second week , starting at week 6 of gemcitabine therapy .
METHODS	Group 2 received 5 mg/kg bevacizumab for 12 weeks ( six doses ) , every second week , starting at week 1 of gemcitabine therapy .
METHODS	The objective of the present study was to assess the rate of complete radical resection and overall survival .
RESULTS	A total of 30 patients were enrolled : 19 patients had unresectable and 11 patients had borderline-resectable pancreatic cancer .
RESULTS	Eleven patients ( 37 % ) underwent resection .
RESULTS	The median overall survival of patients who underwent tumor resection was 13 months ( 95 % confidence interval = 11-15 months ) .
CONCLUSIONS	In general , adding bevacizumab to neoadjuvant gemcitabine does not improve outcomes for patients with locally advanced pancreatic cancer .
CONCLUSIONS	However , in individual cases , surgery is consequently possible and prolonged survival may be observed .

###25581660
BACKGROUND	Heavy drinking poses significant risks to the health and survival of individuals infected with HIV , particularly those coinfected with hepatitis C virus ( HCV ) .
BACKGROUND	However , little is known about patients ' perceptions of these risks , and whether these perceptions relate to their alcohol consumption .
METHODS	A sample of 254 heavily drinking HIV primary care patients ( 78 % male ; 94.5 % minority ; 31.8 % with HCV ) reported on their perceptions of the medical risks of drinking and on their alcohol consumption prior to participation in a drinking-reduction intervention trial .
RESULTS	In the HIV-infected sample as a whole , 62.9 % reported that they had a medical problem made worse by drinking , and 64.3 % reported restricting drinking to avoid future medical problems .
RESULTS	Although patients coinfected with HIV/HCV reported greater efforts to restrict drinking to avoid future medical problems ( adjusted odds ratio = 1.94 ) , their reported drinking quantity and frequency did not differ from that of HIV mono-infected patients .
RESULTS	Awareness of medical risk was not associated with drinking level .
RESULTS	Effort to restrict drinking to avoid medical risk was associated with lower drinking quantity , frequency , and binge frequency ( ps < 0.05 ) , but the association with binge frequency was specific to patients without HCV .
CONCLUSIONS	Over one-third of HIV patients are unaware of the medical risks of drinking , and do not restrict use , suggesting the need for intervention in this group .
CONCLUSIONS	Patients coinfected with HIV/HCV may report more effort to restrict drinking , but their reported drinking quantity and frequency suggest that they are actually drinking just as heavily as HIV mono-infected patients .
CONCLUSIONS	Awareness of medical risk was unrelated to drinking , which suggests the need for interventions consisting of more than simple education .
CONCLUSIONS	However , reported effort to restrict drinking did predict less drinking , suggesting the importance of patient commitment and initiative in change .

###24534599
OBJECTIVE	In a nonclinical trial setting , we sought to determine the proportion of individuals with coronary artery disease ( CAD ) with optimal risk factor levels based on the COURAGE ( Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation ) trial .
BACKGROUND	In the COURAGE trial , the addition of percutaneous coronary intervention ( PCI ) to optimal medical therapy did not reduce the risk of death or myocardial infarction in stable CAD patients but resulted in more revascularization procedures .
METHODS	The REGARDS ( REasons for Geographic And Racial Differences in Stroke ) study is a national prospective cohort study of 30,239 African-American and white community-dwelling individuals older than 45 years of age who enrolled in 2003 through 2007 .
METHODS	We calculated the proportion of 3,167 participants with self-reported CAD meeting 7 risk factor goals based on the COURAGE trial : 1 ) aspirin use ; 2 ) systolic blood pressure < 130 mm Hg and diastolic blood pressure < 85 mm Hg ( < 80 mm Hg if diabetic ) ; 3 ) low-density lipoprotein cholesterol < 85 mg/dl , high-density lipoprotein cholesterol > 40 mg/dl , and triglycerides < 150 mg/dl ; 4 ) fasting glucose < 126 mg/dl ; 5 ) nonsmoking status ; 6 ) body mass index < 25 kg/m ( 2 ) ; and 7 ) exercise4 days per week .
RESULTS	The mean age of participants was 69 9 years ; 33 % were African American and 35 % were female .
RESULTS	Overall , the median number of goals met was 4 .
RESULTS	Less than one-fourth met5 of the 7 goals , and 16 % metall 3 goals for aspirin , blood pressure , and low-density lipoprotein cholesterol .
RESULTS	Older age , white race , higher income , more education , and higher physical functioning were independently associated with meeting more goals .
CONCLUSIONS	There is substantial room for improvement in risk factor reduction among U.S. individuals with CAD .

###24569618
OBJECTIVE	This trial examined diaries of hot flash events reported upon occurrence to assess the test/retest reliability of the diaries and their ability to measure treatment effects on hot flash frequency and severity .
METHODS	Forty-two postmenopausal women ( aged 40 y ; 5-50 hot flashes/wk ) were randomized ( 3:3:1 ) to placebo , raloxifene 60 mg , or paroxetine 20 mg daily for 12 weeks .
METHODS	Diaries of hot flash frequency and severity were evaluated at 1-week intervals ( twice before study treatment and thrice during study treatment ) .
RESULTS	Forty-one women were evaluated .
RESULTS	Baseline characteristics were similar between groups ( eg , mean , 29.8 hot flashes/wk ) .
RESULTS	Concordance correlation coefficients between screening ( week -2 ) and baseline ( week -1 ) measures of hot flash frequency and severity were 0.73 and 0.71 , respectively .
RESULTS	After 12 weeks , the mean ( 95 % CI ) percent changes from baseline in weekly hot flash frequency were as follows : placebo , -37.4 % ( -60.9 to -14.0 ) ; raloxifene , -14.2 % ( -37.7 to 9.3 ) ; paroxetine , -49.8 % ( -88.6 to -11.0 ) ; the mean ( 95 % CI ) percent changes in hot flash severity were as follows : placebo , -39.9 % ( -69.1 to -10.8 ) ; raloxifene , -9.6 % ( -38.8 to 19.6 ) ; paroxetine , -36.6 % ( -84.7 to 11.5 ) .
RESULTS	There were no significant differences in hot flash diary results between treatment groups .
CONCLUSIONS	Measures of hot flash frequency and severity show acceptable test/retest reliability between screening and baseline .
CONCLUSIONS	Reductions in vasomotor symptoms by raloxifene are numerically less than those seen with placebo , but no statistically significant treatment differences have been documented in this small study .
CONCLUSIONS	The large effect of placebo and the significant reduction in vasomotor symptoms by paroxetine are consistent with other studies .
CONCLUSIONS	The diary seems to be suitable for use in hot flash clinical trials .

###25136050
BACKGROUND	We present a long-term safety , immunogenicity , and effectiveness study of a quadrivalent human papillomavirus ( HPV4 ) vaccine .
METHODS	Sexually naive boys and girls aged 9 to 15 years ( N = 1781 ) were assigned ( 2:1 ) to receive HPV4 vaccine or saline placebo at day 1 and months 2 and 6 .
METHODS	At month 30 , the placebo group ( n = 482 ) received HPV4 vaccine following the same regimen and both cohorts were followed through month 96 .
METHODS	Subjects 16 years were eligible for effectiveness evaluations .
METHODS	The primary objective was to evaluate the long-term anti-HPV6 / 11/16/18 serological levels .
METHODS	The secondary objective was to estimate vaccine effectiveness against HPV6/11/16 / 18-related persistent infection or disease .
RESULTS	For each of the HPV4 vaccine types , vaccination-induced anti-HPV response persisted through month 96 .
RESULTS	Among 429 subjects who received HPV4 vaccine at a mean age of 12 , none developed HPV6/11/16 / 18-related disease or persistent infection of 12 months ' duration .
RESULTS	Acquisition of new sexual partners ( among those 16 years ) was 1 per year .
RESULTS	Subjects receiving HPV4 vaccine at month 30 ( mean age 15 years ) had a similar baseline rate of seropositivity to 1 of the 4 HPV types to those vaccinated at day 1 ( mean age 12 years ; 1.9 % [ 9 of 474 ] vs 1.7 % [ 20 of 1157 ] ) ; however , 4 of the 9 subjects vaccinated at the later age were seropositive to 3 vaccine types , indicating previous HPV exposure .
RESULTS	No new significant serious adverse events were observed for 8 years postvaccination in both genders .
CONCLUSIONS	When administered to adolescents , the HPV4 vaccine demonstrated durability in clinically effective protection and sustained antibody titers over 8 years .

###24359572
BACKGROUND	A strong association exists between the use of tamsulosin and the occurance of intraoperative floppy iris syndrome .
BACKGROUND	Several methods were advocated to overcome the progressive intraopertive miosis.Our purpose was to investigate the effect of a mydriatic-cocktail soaked cellulose sponge on perioperative pupil diameter in tamsulosin-treated patients undergoing elective cataract surgery .
METHODS	Patients using tamsulosin were dilated either with mydriatic-cocktail soaked sponge ( group 1 ) or with conventional eyedrop regimen ( group 2 ) .
METHODS	Control patients not taking any 1 adrenergic receptor inhibtors were also dilated with mydriatic sponge ( group 3 ) .
METHODS	In all groups oxybuprocain 0.4 % , cocain 4 % , tropicamide 1 % , phenylephrine 10 % , diclophenac 0.1 % along with chloramphenicol 0.5 % were used preoperatively.Pupil diameter ( mm ) was measured preoperatively , after nucleus delivery , and before IOL implantation .
METHODS	Adverse effects associated with the use of sponge , minor and major intraoperative complications , the use of iris retractors and operation time were recorded.Differences in general between groups were analyzed with a one way analysis of variance ( ANOVA ) ; differences between groups in proportions were assessed by Fisher 's exact test .
RESULTS	Mean pupil diameter ( mm ) was preopertively : 7.52 1.21 , 7.30 1.55 and 7.99 0.96 ( ANOVA : p = 0.079 ) ; after nucleus delivery : 6 1.20 , 6.29 1.12 and 6.52 0.81 ( ANOVA : p = 0.123 ) ; before IOL implantation : 5.46 1.06 , 5.83 1.09 and 6.17 0.89 ( ANOVA : p = 0.0291 ) .
RESULTS	No adverse effect related to sponge use was detected .
RESULTS	Frequency of minor complications , and iris hook use was similar in the two tamsulosin treated group .
RESULTS	Operation time did not differ significantly in the three groups .
CONCLUSIONS	We have found that using a mydriatic cocktail-soaked wick - an alternative way to achieve intraoperative mydriasis for cataract surgery - was as effective and safe as the conventional repeated eyedrops regiment for tamsulosin treated patients .
BACKGROUND	Current Controlled Trials ISRCTN37834752 .

###24368464
OBJECTIVE	Gastroparesis remains a challenging syndrome to manage , with few effective treatments and a lack of rigorously controlled trials .
OBJECTIVE	Tricyclic antidepressants are often used to treat refractory symptoms of nausea , vomiting , and abdominal pain .
OBJECTIVE	Evidence from well-designed studies for this use is lacking .
OBJECTIVE	To determine whether treatment with nortriptyline results in symptomatic improvement in patients with idiopathic gastroparesis .
METHODS	The NORIG ( Nortriptyline for Idiopathic Gastroparesis ) trial , a 15-week multicenter , parallel-group , placebo-controlled , double-masked , randomized clinical trial from the National Institute of Diabetes and Digestive and Kidney Diseases Gastroparesis Clinical Research Consortium ( GpCRC ) , comparing nortriptyline with placebo for symptomatic relief in idiopathic gastroparesis .
METHODS	One hundred thirty patients with idiopathic gastroparesis were enrolled between March 2009 and June 2012 at 7 US academic medical centers .
METHODS	Patient follow-up was completed in October 2012 .
METHODS	Inclusion criteria included delayed gastric emptying and moderate to severe symptom scores using the Gastroparesis Cardinal Symptom Index ( GCSI ) .
METHODS	INTERVENTIONS Nortriptyline vs placebo .
METHODS	Study drug dose was increased at 3-week intervals ( 10 , 25 , 50 , 75 mg ) up to 75 mg at 12 weeks .
METHODS	The primary outcome measure of symptomatic improvement was a decrease from the patient 's baseline GCSI score of at least 50 % on 2 consecutive 3-week GCSI assessments during 15 weeks of treatment .
RESULTS	The primary symptomatic improvement outcome did not differ between 65 patients randomized to nortriptyline vs 65 patients randomized to placebo : 15 ( 23 % [ 95 % CI , 14 % -35 % ] ) in the nortriptyline group vs 14 ( 21 % [ 95 % CI , 12 % -34 % ] ) in the placebo group ( P = .86 ) .
RESULTS	Treatment was stopped more often in the nortriptyline group ( 19 [ 29 % { 95 % CI , 19 % -42 % } ] ) than in the placebo group ( 6 [ 9 % ] { 95 % CI , 3 % -19 % } ] ) ( P = .007 ) , but numbers of adverse events were not different ( 27 [ 95 % CI , 18-39 ] vs 28 [ 95 % CI , 19-40 ] ) ( P = .89 ) .
CONCLUSIONS	Among patients with idiopathic gastroparesis , the use of nortriptyline compared with placebo for 15 weeks did not result in improvement in overall symptoms .
CONCLUSIONS	These findings do not support the use of nortriptyline for idiopathic gastroparesis .
BACKGROUND	clinicaltrials.gov Identifier : NCT00765895 .

###26321103
BACKGROUND	Experimental and clinical evidence suggests that cyclosporine may attenuate reperfusion injury and reduce myocardial infarct size .
BACKGROUND	We aimed to test whether cyclosporine would improve clinical outcomes and prevent adverse left ventricular remodeling .
METHODS	In a multicenter , double-blind , randomized trial , we assigned 970 patients with an acute anterior ST-segment elevation myocardial infarction ( STEMI ) who were undergoing percutaneous coronary intervention ( PCI ) within 12 hours after symptom onset and who had complete occlusion of the culprit coronary artery to receive a bolus injection of cyclosporine ( administered intravenously at a dose of 2.5 mg per kilogram of body weight ) or matching placebo before coronary recanalization .
METHODS	The primary outcome was a composite of death from any cause , worsening of heart failure during the initial hospitalization , rehospitalization for heart failure , or adverse left ventricular remodeling at 1 year .
METHODS	Adverse left ventricular remodeling was defined as an increase of 15 % or more in the left ventricular end-diastolic volume .
RESULTS	A total of 395 patients in the cyclosporine group and 396 in the placebo group received the assigned study drug and had data that could be evaluated for the primary outcome at 1 year .
RESULTS	The rate of the primary outcome was 59.0 % in the cyclosporine group and 58.1 % in the control group ( odds ratio , 1.04 ; 95 % confidence interval [ CI ] , 0.78 to 1.39 ; P = 0.77 ) .
RESULTS	Cyclosporine did not reduce the incidence of the separate clinical components of the primary outcome or other events , including recurrent infarction , unstable angina , and stroke .
RESULTS	No significant difference in the safety profile was observed between the two treatment groups .
CONCLUSIONS	In patients with anterior STEMI who had been referred for primary PCI , intravenous cyclosporine did not result in better clinical outcomes than those with placebo and did not prevent adverse left ventricular remodeling at 1 year .
CONCLUSIONS	( Funded by the French Ministry of Health and NeuroVive Pharmaceutical ; CIRCUS ClinicalTrials.gov number , NCT01502774 ; EudraCT number , 2009-013713-99 . )

###24975522
OBJECTIVE	To evaluate the effects of acute and daily consumption of high-oleic peanuts ( HOP ) on inflammation and glucose homeostasis in overweight/obese men .
METHODS	In a 4-week randomized clinical trial , males with body mass index of 29.8 2.3 kg/m ( 2 ) and aged 18-50 years were assigned to the groups : control ( CT , n = 22 ) ; conventional peanuts ( CVP , n = 22 ) ; or HOP ( n = 21 ) .
METHODS	They followed a hypocaloric-diet with or without 56 g/day of CVP or HOP .
METHODS	Main outcomes were changes in fasting blood biomarkers and postprandial insulin , glucose , tumor necrosis factor-alfa ( TNF - ) , and interleukin-10 ( IL-10 ) responses after acute peanut intake .
RESULTS	At baseline , HOP showed significantly lower postprandial responses of glucose , insulin , and TNF - than CVP and CT. .
RESULTS	Changes in fasting blood biomarkers did not differ between groups after the 4-week intervention .
RESULTS	However , within groups , total cholesterol decreased in CT , and all groups reduced High-density lipoprotein ( HDL-c ) .
RESULTS	Triglycerides were reduced in HOP and CVP .
RESULTS	IL-10 increased significantly in all groups while only the CT and CVP showed increased TNF - after intervention .
CONCLUSIONS	Acute high-oleic peanut consumption leads to stronger moderation of postprandial glucose , insulin , and TNF - concentrations than CVP and control meal intake .
CONCLUSIONS	Whether daily intake of high-oleic peanuts has additional benefits to CVP remains uncertain .

###25855926
OBJECTIVE	To evaluate the safety and efficacy of urinary kallidinogenase for recombinant tissue-type plasminogen activator ( rt-PA ) intravenous thrombolytic treatment in patients with acute cerebral infarction .
METHODS	All 200 patients with acute cerebral infarction were randomized 1:1 into an experimental group ( 100 cases ) and a control group ( 100 cases ) .
METHODS	Patients in the control group were administrated rt-PA ( 0/9 mg/kg ) while patients in the experimental group were given urinary kallidinogenase by intravenous drip ( 0.15 PNAU/d , for 7 days ) after rt-PA intravenous thrombolytic treatment ( 0.9 mg/kg ) .
METHODS	The main evaluation index was NIHSS and BI .
RESULTS	Compared to the control group , the NIHSS scores were significantly lower 7 and 90 days after thrombolytic therapy ( t = 2.391 , 2.714 ; p < 0.05 ) .
RESULTS	BI scores were obviously higher at 90 days after thrombolytic therapy in the experimental group ( t = 2.675 , p < 0.05 ) .
CONCLUSIONS	Urinary kallidinogenase may improve the treatment effect for rt-PA intravenous thrombolytic treatment in patients with acute cerebral infraction .

###24903347
OBJECTIVE	To assess the impact of dutasteride compared with placebo on nocturia in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia , using pooled data from dutasteride phase III studies .
METHODS	Nocturia was assessed using Question 7 of the International Prostate Symptom Score questionnaire .
METHODS	Efficacy measures included : mean change in nocturia at 24 months ; proportion of patients with improvement/worsening in nocturia ; nocturnal voiding frequency at baseline and study end , overall and by baseline subgroups ; and nocturnal voiding frequency < 2 at study end in patients with baseline score 2 .
RESULTS	In total , 4,321 patients with a mean age of 66 years were evaluated .
RESULTS	From month 12 onwards , mean nocturia improvements were significantly superior with dutasteride than with placebo ( p 0.05 ) .
RESULTS	Reduction in nocturia was significantly better with dutasteride than with placebo across all baseline subgroups tested ( p 0.05 ) .
RESULTS	Also at month 24 , dutasteride therapy resulted in a greater proportion of subjects with nocturia improvement compared with placebo ( p 0.05 ) , with the largest treatment group differences in subjects with a baseline nocturia score of 2 or 3 .
RESULTS	Among patients with significant nocturia at baseline ( score 2 ) , significantly more subjects with dutasteride versus placebo had a score < 2 at month 24 ( 26 vs. 19 % , p < 0.001 ) .
CONCLUSIONS	After 24 months of treatment , dutasteride treatment provided significantly greater improvements in nocturia , and less worsening , compared with placebo , primarily in subjects with two or three nocturia episodes per night .
CONCLUSIONS	Studies specifically designed to assess nocturia are required to prospectively confirm these findings .

###25644349
BACKGROUND	There is increasing interest in the extraskeletal effects of vitamin D , particularly in the obese state with regard to the development of insulin resistance and diabetes .
OBJECTIVE	The objective of the study was to determine the effect of 2 doses of cholecalciferol ( vitamin D3 ) supplementation on insulin action ( Si ) and pancreatic - cell function in obese adolescents .
METHODS	We performed a 12-wk double-blind , randomized comparison of the effect of vitamin D3 supplementation on Si and - cell function in obese Caucasian adolescents ( body mass index > 95 ( th ) percentile ) .
METHODS	The subjects were randomly assigned to receive either 400 IU/d ( n = 25 ) or 2000 IU/d ( n = 26 ) of vitamin D3 .
METHODS	Each subject underwent a 7-sample 75 g oral glucose tolerance test , with glucose , insulin , and C-peptide measurements , to calculate Si and - cell function as assessed by the disposition index ( DI ) , with use of the oral minimal model before and after supplementation .
METHODS	A total of 51 subjects aged 15.0 1.9 y were enrolled .
METHODS	Included for analysis at follow-up were a total of 46 subjects ( 20 male and 26 female adolescents ) , 23 in each group .
RESULTS	Initial serum 25-hydroxyvitamin D [ 25 ( OH ) D ] was 24.0 8.1 g/L .
RESULTS	There was no correlation between 25 ( OH ) D concentrations and Si or DI .
RESULTS	There was a modest but significant increase in 25 ( OH ) D concentration in the 2000 IU/d group ( 3.1 6.5 g/L , P = 0.04 ) but not in the 400 IU/d group ( P = 0.39 ) .
RESULTS	There was no change in Si or DI following vitamin D3 supplementation in either of the treatment groups ( all P > 0.10 ) .
CONCLUSIONS	The current study shows no effect from vitamin D3 supplementation , irrespective of its dose , on - cell function or insulin action in obese nondiabetic adolescents with relatively good vitamin D status .
CONCLUSIONS	Whether obese adolescents with vitamin D deficiency and impaired glucose metabolism would respond differently to vitamin D3 supplementation remains unclear and warrants further studies .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT00858247 .

###24980704
BACKGROUND	Gestational diabetes mellitus ( GDM ) is associated with both maternal and offspring adverse effects .
BACKGROUND	The World Health Organization ( WHO ) has recently adopted novel GDM criteria .
BACKGROUND	The aim of this study was to evaluate the former WHO and a simplified version of the new International Association for Diabetes in Pregnancy Study Group ( IADPSG ) criteria as to prevalence of and risk factors for GDM in a Nordic Caucasian population .
METHODS	A 75 g oral glucose tolerance test was performed in 687 women at 18-22 and 32-36 pregnancy weeks .
METHODS	GDM was defined according to the WHO criteria as fasting plasma glucose 7.0 mmol/L and/or 2-hour plasma glucose 7.8 mmol/L and by a simplified version of the IADPSG criteria as either fasting glucose 5.1 mmol/L and/or 2-h plasma glucose 8.5 mmol/L .
METHODS	One-hour glucose values were not available and were thus not included in the diagnosis of GDM by IADPSG .
METHODS	Prevalence of GDM during pregnancy and risk factors for GDM at 18-22 weeks were studied in retrospect according to each of the two criteria .
RESULTS	The total prevalence of GDM during pregnancy was 6.1 % ( 42/687 ) for the WHO criteria and 7.4 % ( 51/687 ) for the simplified IADPSG criteria .
RESULTS	High maternal age and short stature were independently associated with WHO GDM .
RESULTS	Maternal age , fasting insulin and no regular exercise at 18-22 pregnancy weeks associated with simplified IADPSG GDM .
CONCLUSIONS	Simplified IADPSG criteria moderately increase GDM prevalence compared with the WHO criteria .
CONCLUSIONS	Risk factors for GDM differ with the diagnostic criteria used .

###24290606
OBJECTIVE	At the doses typically used to treat hypertriacylglycerolemia , fish oil may increase low-density lipoprotein ( LDL ) cholesterol and blood glucose levels .
OBJECTIVE	The aim of the present study was to verify whether soy could attenuate the effects of fish oil on blood lipids and carbohydrate metabolism in patients with metabolic syndrome .
METHODS	Sixty-five women ( 47.9 9.98 y ) were studied with the use of a parallel , randomized design .
METHODS	The control group maintained the usual diet ; the second group received 29.14 g/d of soy ( kinako ) ; the third group received 3 g/d of fish oil n-3 fatty acids ; and the fourth group received fish oil ( 3 g/d ) and kinako ( 29.14 g/d ) .
METHODS	Assessments were performed at baseline and after 45 and 90 d.
RESULTS	In relation to baseline values , fish oil increased ( P < 0.05 ) total and LDL cholesterol , glucose , insulin , and homeostasis model assessment of insulin resistance levels after 90 d. Comparisons among groups demonstrated a decrease ( P < 0.05 ) in total cholesterol in the fish oil and kinako group after 90 d as compared with the fish oil group .
RESULTS	LDL cholesterol decreased ( P < 0.01 ) in the kinako group as compared with the fish oil group .
RESULTS	Blood glucose and homeostasis model assessment of insulin resistance levels decreased after 90 d ( P < 0.01 and P < 0.05 , respectively ) and insulin levels decreased ( P < 0.05 ) after 45 d when the kinako group was compared with the fish oil group .
CONCLUSIONS	The present study showed that kinako moderates the adverse effects of high doses of fish oil on LDL cholesterol , total cholesterol , and glucose metabolism levels .

###24640432
OBJECTIVE	To compare the relative plaque control efficacy of a marketed 0.454 % stabilized stannous fluoride ( SnF2 ) dentifrice relative to a triclosan/copolymer dentifrice using digital plaque imaging analysis ( DPIA ) .
METHODS	This was a randomized , two-treatment , double-blind , parallel group design study that compared SnF2 and triclosan/copolymer dentifrices over a period of 3 weeks .
METHODS	DPIA was used to capture a digital image of the maxillary and mandibular anterior facial surfaces of 12 teeth and to calculate plaque area coverage .
METHODS	Overnight DPIA images were taken at a baseline visit after which subjects were randomly assigned to one of the two treatment groups and were required to brush with their assigned dentifrice according to each manufacturer 's instructions .
METHODS	Subjects had DPIA assessments on two separate days at the end of Week 3 .
RESULTS	96 subjects were randomized to treatment .
RESULTS	Plaque area data for 47 subjects per treatment group were compared at Week 3 using ANCOVA .
RESULTS	The SnF2 group demonstrated a statistically significant reduction in overnight plaque at Week 3 compared to baseline ( P = 0.002 ) .
RESULTS	The reduction for the triclosan group at Week 3 compared to baseline was not statistically significant ( P = 0.24 ) .
RESULTS	At Week 3 , the SnF2 group demonstrated a 17 % lower adjusted mean for overnight plaque relative to the triclosan group with a mean difference that was statistically significant ( P < 0.05 ) .
RESULTS	The Week 3 adjusted mean change from baseline in overnight plaque for the SnF2 group was 3 times greater versus that of the triclosan group ( P < 0.05 ) .

###25131073
BACKGROUND	The study purpose was to analyze 5-year outcomes in a prospective , randomized trial of alemtuzumab ( ALEM ) versus rabbit antithymocyte globulin ( rATG ) induction in simultaneous kidney-pancreas transplantation ( SKPT ) .
METHODS	From February 2005 through October 2008 , a total of 46 SKPTs ( 45 portal-enteric drainage ) were prospectively randomized to receive either single-dose ALEM ( 30 mg intraoperatively ) or multiple-dose rATG antibody induction ( starting intraoperatively , minimum of 3 doses administered ) with tacrolimus/mycophenolate and/or steroids .
RESULTS	Of 222 kidney transplant patients enrolled in the study , 46 received SKPTs ; 28 ( 61 % ) received ALEM and 18 ( 39 % ) received rATG induction .
RESULTS	Follow-up ranged from 54 to 98 months ( mean , 69 months ) .
RESULTS	There were no significant differences between the 2 groups in 5-year patient ( 82 % ALEM vs 89 % rATG ) , kidney graft ( 79 % ALEM vs 72 % rATG ) , or pancreas graft ( 64 % ALEM vs 56 % rATG ) survival rates .
RESULTS	Death-censored kidney ( 90 % ALEM vs 75 % rATG ) and pancreas ( 71 % ALEM vs 56 % rATG ) graft survival rates were likewise comparable ( both , P = NS ) .
RESULTS	Acute rejection ( 21 % ALEM vs 44 % rATG ; P = .11 ) and major infection ( 39 % ALEM vs 67 % rATG ; P = .13 ) rates were slightly lower in the ALEM group ; cytomegalovirus infections were significantly lower ( 0 % ALEM vs 17 % rATG ; P = .05 ) .
RESULTS	The incidence of late acute rejection was low in both groups .
RESULTS	There were no differences in early pancreas thromboses ( 3.6 % ALEM vs 11 % rATG ) , postoperative bleeding ( 11 % ALEM vs 0 % rATG ) , other surgical complications , or readmissions between groups .
RESULTS	In patients with functioning grafts , 5-year mean serum creatinine ( 1.4 ALEM vs 1.6 mg/dL rATG ) , calculated abbreviated Modification of Diet in Renal Disease glomerular filtration rate ( 55 ALEM vs 52 mL/min/1 .73 m ( 2 ) rATG ) , glycosylated hemoglobin ( both 5.4 % ) , and C-peptide ( 2.2 ALEM vs 2.3 ng/mL rATG ) levels were similar .
CONCLUSIONS	Single-dose ALEM and multiple dose rATG induction provided similar medium-term patient , kidney , and pancreas graft function and survival rates .
CONCLUSIONS	ALEM induction may be associated with less acute rejection and major infection over the long term .

###26160958
OBJECTIVE	To determine the mechanisms by which extended-release nicotinic acid reduces circulating lipoprotein ( a ) concentrations in hypertriglyceridemic patients .
RESULTS	Eight nondiabetic , obese male subjects ( aged 4812 years ; body mass index , 31.21.8 kg/m ( 2 ) ) with hypertriglyceridemia ( triglycerides , 22678 mg/dL ) were enrolled in an 8 week , double blind , placebo-controlled cross-over study .
RESULTS	At the end of each treatment phase , fasted subjects received a 10 mol/L per kg bolus injection of [ 5,5,5 - ( 2 ) H3 ] - l-Leucine immediately followed by constant infusion of [ 5,5,5 - ( 2 ) H3 ] - l-Leucine ( 10 mol L ( -1 ) kg ( -1 ) h ( -1 ) ) for 14 hours , and blood samples were collected .
RESULTS	A liquid chromatography-tandem mass spectrometry method was used to study apolipoprotein ( a ) ( Apo ( a ) ) kinetics .
RESULTS	The fractional catabolic rate of Apo ( a ) was calculated with a single compartmental model using the apolipoprotein B100 ( ApoB100 ) containing very low density lipoprotein tracer enrichment as a precursor pool .
RESULTS	Extended-release nicotinic acid decreased plasma triglycerides ( -46 % ; P = 0.023 ) , raised high-density lipoprotein cholesterol ( +20 % ; P = 0.008 ) , and decreased Apo ( a ) plasma concentrations ( -20 % ; P = 0.008 ) .
RESULTS	Extended-release nicotinic acid also decreased ApoB100 ( 22 % ; P = 0.008 ) and proprotein convertase subtilisin/kexin type 9 ( PCSK9 , -29 % ; P = 0.008 ) plasma concentrations .
RESULTS	Apo ( a ) fractional catabolic rate and production rates were decreased by 37 % ( 0.580.28 versus 0.360.19 pool/d ; P = 0.008 ) and 50 % ( 1.40.8 versus 0.70.4 nmol/kg per day ; P = 0.008 ) , respectively .
CONCLUSIONS	Extended-release nicotinic acid treatment decreased Apo ( a ) plasma concentrations by 20 % , production rates by 50 % , and catabolism by 37 % .
CONCLUSIONS	ApoB100 and PCSK9 concentrations were also decreased by treatment , but no correlation was found with Apo ( a ) kinetic parameters .

###25141084
OBJECTIVE	We sought to compare the effects of physical practice ( PP ) and mental practice ( MP ) on the immediate and long-term learning of the finger-to-thumb opposition sequence task ( FOS ) in children ; in addition , we investigated the transfer of this learning to an untrained sequence of movements and to the contralateral untrained hand .
METHODS	This study included thirty-six 9 - and 10-year-old children who were randomly allocated into 3 groups : MP , PP , and no practice ( NP ) .
METHODS	The MP and PP groups were subjected to a single session of training with the dominant trained hand .
METHODS	MP participants were trained by mentally rehearsing the movements , PP participants were trained by executing the movements , and the NP group had no training .
METHODS	The performance of the trained sequence ( TS ) and untrained reverse sequence ( URS ) by each of the 3 groups was evaluated under identical conditions before training , after 5 min , and at 4 days , 7 days , and 28 days after training .
RESULTS	Whereas both trained groups ( MP and PP ) showed statistically significant improvement in TS using the trained hand at all assessment points after the training , only MP participants were able to transfer the performance gains from the TS to the URS and from the trained hand to the untrained opposite hand .
CONCLUSIONS	Children were able to learn the FOS through MP or PP with a similar level of performance .
CONCLUSIONS	Unlike PP , MP allowed for the transfer of performance gain to the URS and to the opposite hand , suggesting that the internal representations developed by MP were effector-independent .

###25449505
BACKGROUND	Renal dysfunction ( RD ) is associated with poor outcome in systolic heart failure ( HF ) .
BACKGROUND	Left ventricular ejection fraction ( LVEF ) is not depressed to a greater extent in patients with RD compared to patients with normal renal function , but it is relatively unknown whether other measures of myocardial function are impaired by RD. .
BACKGROUND	The objective of the present study is to evaluate whether RD in systolic HF is associated with excessive impairment of myocardial function , evaluated by strain analysis and cardiac biomarkers .
METHODS	Patients with LVEF < 0.45 % were enrolled from an outpatient HF clinic .
METHODS	The patients underwent advanced echocardiography .
METHODS	Glomerular filtration rate was estimated by the CKD-EPI equation ( eGFR ) and patients grouped by eGFR : eGFR group-I , 90 ml/min/1 .73 m ( 2 ) ; eGFR group-II , 60-89 ml/min/1 .73 m ( 2 ) ; and eGFR group-III , 59 ml/min/1 .73 m ( 2 ) .
METHODS	Multivariate regression models were developed to evaluate the associations between eGFR groups , echocardiographic measures and cardiac biomarkers .
RESULTS	A total of 149 patients participated in the study .
RESULTS	Median age was 69 years , 26 % were female ; LVEF was 33 % .
RESULTS	Patients with a low eGFR were older ( P < 0.001 ) , but there were no differences in frequency of atrial fibrillation , hypertension , diabetes and ischemic heart disease between eGFR groups ( P > 0.05 for all ) .
RESULTS	RD was associated with impaired global longitudinal strain ( P = 0.018 ) , increased E/e ' ( P = 0.032 ) , larger left atria ( P = 0.038 ) and increased levels of proANP ( P < 0.001 ) , NT-proBNP ( P < 0.001 ) and troponin I ( P = 0.019 ) after adjustment for traditional confounders .
CONCLUSIONS	Echocardiographic measures and biomarkers reflecting different aspects of myocardial function are impaired in systolic HF patients with RD and the increased mortality risk in these patients may partly be explained by a depressed cardiac function .

###25183661
BACKGROUND	Previously , in a 40-week , randomised , double-blind , placebo-controlled core study comprising three phases ( 9-week dose confirmation , 5-week open-label dose optimisation and 6-month maintenance of effect ) in adults with attention-deficit/hyperactivity disorder ( ADHD ) , methylphenidate modified-release long-acting formulation ( MPH-LA ) at 40-80 mg/day controlled ADHD symptoms as well as decreased functional impairment with a good tolerability profile ( NCT01259492 ) .
BACKGROUND	Here , we report the long-term efficacy and safety from a 26-week , open-label extension phase of the same study ( NCT01338818 ) .
METHODS	Patients in the extension study ( n = 298 ) initiated treatment with MPH-LA ( 20 mg/day ) , up-titrated in increments of 20 mg/week to reach individual patient 's daily optimal dose of 40-80 mg .
METHODS	Adverse events ( AEs ) and serious adverse events ( SAEs ) were reported at the end of extension study for events monitored from ( 1 ) maintenance of effect phase baseline ( core study ; 12 months ) and ( 2 ) extension study baseline ( 6 months ) .
METHODS	Mean changes in DSM-IV ADHD Rating Scale ( DSM-IV ADHD RS ) and Sheehan Disability Scale ( SDS ) total scores are reported for both the timelines .
METHODS	Efficacy was also evaluated using clinician-rated instruments , namely Clinical Global Impression-Improvement Scale ( CGI-I ) and Clinical Global Impression-Severity Scale ( CGI-S ) .
RESULTS	No unexpected AEs were reported in the extension study .
RESULTS	Incidence of SAEs reported during 6 months and 12 months were similar ( 0.7 % ) , and no deaths were reported .
RESULTS	No SAEs were considered attributable to the drug at the end of 12 months .
RESULTS	There were no reports of patients with QT , QTcB or QTcF > 500 ms. The mean improvement in DSM-IV ADHD RS and SDS total scores at the end of 12 months were 0.9 and 1.4 points , respectively ; and at the end of 6 months were 7.2 and 4.8 , respectively .
RESULTS	The proportion of patients with improvement in CGI-S scale was 31.4 % and 52.1 % at the end of 12 and 6 months , respectively .
RESULTS	Overall , 69.4 % of patients showed clinical improvement in CGI-I scale at the end of 6 months .
CONCLUSIONS	In adult patients with ADHD , use of MPH-LA up to 1 year continued to be well tolerated while maintaining the clinical efficacy .

###25826885
OBJECTIVE	To investigate the efficiency of total knee arthroplasty ( TKA ) for varus osteoarthritic knees with tibial bone resection determined by lateral tibiofemoral joint 90 flexional gap measurement .
METHODS	Between March and June 2013 , 60 patients ( 60 knees ) with varus osteoarthritic knees underwent TKA .
METHODS	All patients were randomly divided into traditional osteotomy group ( control group , 30 cases ) and lateral tibiofemoral joint 90 flexional gap measurement resection group ( trial group , 30 cases ) .
METHODS	There was no significant difference in gender , age , affected side , body mass index and preoperative knee society score ( KSS ) , range of motion ( ROM ) of the knee , anatomic tibiofemoral angle ( ATFA ) , patellar tilt angle , posterior condylar offset ( PCO ) , and joint line height between 2 groups ( P > 0.05 ) .
METHODS	The bone resection thickness of the distal femoral lateral condyle , femoral posterior lateral condyle , and lateral tibial plateau were measured ; and the X-ray films were taken to measure and compare ATFA , patellar tilt angle , PCO , and joint line height after TKA .
METHODS	The knee function recovery was evaluated with KSS score and ROM of the knee .
RESULTS	The bone resection thickness of the lateral tibial plateau and distal femoral lateral condyle in trial group was significantly smaller than that in control group ( P < 0.05 ) ; while the bone resection thickness of the femoral posterior lateral condyle was significantly bigger than that in control group ( P < 0.05 ) .
RESULTS	The 10 mm polyethylene insert was used in 19 cases of the trial group and in 8 cases of the control group , showing significant difference ( Z = -4.040 , P = 0.003 ) .
RESULTS	All the patients were followed up 13-16 months ( mean , 14.5 months ) .
RESULTS	Radiography at 6 weeks after TKA indicated that the ATFA , patellar tilt angle , and joint line height had no significant difference between 2 groups ( P > 0.05 ) ; the PCO of trial group was significantly lower than that of control group ( P < 0.05 ) .
RESULTS	The KSS score and ROM of the knee at 12 months after operation were significantly improved when compared with preoperative ones in 2 groups ( P < 0.05 ) , and trial group was significantly better than control group ( P < 0.05 ) .
CONCLUSIONS	It was an effective method to determine bone resection thickness using lateral tibiofemoral joint 90 flexional gap measurement in TKA for varus osteoarthritic knees , which can reduce the bone resection thickness of the tibial plateau and distal femoral lateral condyle and restore the joint line and PCO with better early recovery of the knee function .

###25951307
OBJECTIVE	The aim of the present study was to evaluate the reduction in bacterial loading uing MTAD as an irrigating solution in pulpectomized primary teeth .
METHODS	A randomized , controlled clinical trial was performed that included primary teeth with pulp necrosis .
METHODS	Sixty necrotic canals were included , 30 irrigated with MTAD ( experimental group ) and 30 with 1 % Na0Cl solution ( control group ) ; in all cases , 2 microbiological samples from within the canals were taken with sterile paper points , the first after the canal opening and before the first irrigation , and the second after instrumentation and final irrigation , before obturation .
METHODS	All samples were evaluated by Agar plate method .
RESULTS	The results were statistically analyzed by student ` t ' test .
RESULTS	After analyzing samples before and after irrigation in the control group ( NaOCl ) , we found a significant decrease of bacterial load ( p = < 0.001 ) .
RESULTS	The same occurred in the MTAD group samples ( p = < 0.001 ) .
RESULTS	When both groups were compared post irrigation , a statistically significant difference was observed in favor of MTAD .
CONCLUSIONS	MTAD can be suggested as an alternative irrigant for pulpectomy of necrotic teeth .

###25758601
OBJECTIVE	To describe the imaging standards , grading protocol and baseline characteristics of polypoidal choroidal vasculopathy ( PCV ) from the EVEREST study .
METHODS	In a prospective , multicentre study , confocal scanning laser ophthalmoscope indocyanine green angiography ( ICGA ) was performed using a standardised imaging protocol .
METHODS	All images were graded using standardised , calibrated equipment by fellowship-trained ophthalmologists at the Central Reading Center .
RESULTS	Sixty-one patients with PCV were included in the study .
RESULTS	ICGA characteristics included : nodular appearance stereoscopically ( 56 eyes , 91.8 % ) , hypofluorescent halo ( 42 , 68.9 % ) , abnormal vascular network ( 54 , 88.5 % ) and pulsation of the polyps ( 4 , 6.6 % ) .
RESULTS	Colour fundus photography revealed orange subretinal nodules ( 34 , 55.7 % ) and massive submacular haemorrhage ( 8 , 13.1 % ) .
RESULTS	The mean area of the PCV lesion was 3.11 mm ( 2 ) ( range , 0.2-10 .7 mm ( 2 ) ) .
RESULTS	The vascular channels filled within 7.3-32 .0 s ( mean : 17.9 s ) while the mean filling time for polyps was 21.9 s ( range , 7.3-40 .4 s ) .
RESULTS	Patients with massive submacular haemorrhage were less likely to have abnormal vascular channels seen on ICGA ( 28.6 % vs 83.3 % for those without massive haemorrhage , p = 0.001 ) .
CONCLUSIONS	The imaging and grading protocols and baseline characteristics of a multicentre , randomised controlled trial of PCV are described in detail , and may serve as reference for future randomised , controlled trials on PCV .
BACKGROUND	This work was supported by Novartis Pharma AG , Basel , Switzerland grant number NCT00674323 ( clinicaltrials.gov ) .

###25734218
OBJECTIVE	To evaluate attainment of diabetes-related quality measures with canagliflozin 100 mg , canagliflozin 300 mg , and sitagliptin 100 mg in patients with type 2 diabetes mellitus .
METHODS	This post hoc analysis used pooled data from two 52-week , randomized , double-blind , phase 3 clinical trials that evaluated the comparative efficacy of canagliflozin and sitagliptin .
METHODS	One trial evaluated patients on metformin at baseline with add-on canagliflozin 100 mg , canagliflozin 300 mg , or sitagliptin 100 mg ; the other trial evaluated patients on metformin and a sulfonylurea at baseline with add-on canagliflozin 300 mg or sitagliptin 100 mg .
METHODS	Individual diabetes-related quality measures , including glycated hemoglobin ( A1C ) , blood pressure ( BP ) , low-density lipoprotein cholesterol ( LDL-C ) , body mass index ( BMI ) , and change in body weight , were assessed .
RESULTS	At baseline , the proportions of patients meeting criteria for all quality measures were similar between groups .
RESULTS	At 52 weeks , compared with sitagliptin 100-mg treatment , canagliflozin 100 mg demonstrated either comparable or superior glycemic control .
RESULTS	Additionally , canagliflozin 100 mg versus sitagliptin 100 mg demonstrated superior attainment of BP , BMI , and weight-related quality measures ; no difference was seen with respect to LDL-C .
RESULTS	At 52 weeks , compared with sitagliptin 100-mg treatment , canagliflozin 300 mg demonstrated superior glycemic control at all thresholds of A1C , and superior BP , BMI , and weight-related quality measures ; there was no difference in LDL-C quality measure attainment .
CONCLUSIONS	We evaluated the comparative efficacy of canagliflozin 100 mg , canagliflozin 300 mg , and sitagliptin 100 mg on quality measure attainment after 52 weeks of treatment .
CONCLUSIONS	Compared with sitagliptin 100 mg , canagliflozin 100 mg demonstrated comparable or superior attainment of diabetes-related quality measures .
CONCLUSIONS	Compared with sitagliptin 100 mg , canagliflozin 300 mg demonstrated superior diabetes-related quality measure attainment , including glycemic , BP , and weight-related quality measures ; there was no difference in LDL-C quality measure attainment between either dosage of canagliflozin and the 100-mg dosage of sitagliptin .

###25204714
OBJECTIVE	This study aimed to determine the effect of topical lidocaine on Penetration-Aspiration Scale ( PAS ) scores and patient comfort and tolerance of flexible endoscopic evaluation of swallowing ( FEES ) examinations in dysphagic patients .
METHODS	Adults with dysphagia referred for swallowing evaluation were recruited to participate in consecutive nonanesthetized and then anesthetized FEES examinations .
METHODS	Under endoscopic visualization , participants consumed 6 swallows consisting of graduated volumes of milk , pudding , and cracker in each condition and recorded their discomfort and tolerance in the 2 conditions .
METHODS	Penetration-Aspiration Scale scores were assigned in blinded fashion for each swallow .
RESULTS	Twenty-five adults participated in the study .
RESULTS	Although there was no statistically significant effect of anesthesia on PAS scores ( P = .065 ) , the odds of a higher PAS score were 33 % higher during anesthetized swallows .
RESULTS	The anesthetized condition yielded significantly less discomfort and pain during the examination , significantly less pain and discomfort during insertion and removal of the endoscope , and significantly greater overall tolerance than the nonanesthetized condition .
CONCLUSIONS	The use of topical lidocaine during FEES may impair swallowing ability in patients with dysphagia , but this result does not achieve statistical significance .
CONCLUSIONS	Topical nasal anesthesia significantly reduces subjective pain and discomfort and improves tolerance during FEES .

###25066869
OBJECTIVE	A prospective , randomized comparison of shock wave lithotripsy , retrograde intrarenal surgery and miniperc for the treatment of 1 to 2 cm radiolucent lower calyceal renal calculi was done to evaluate the safety and efficacy of these procedures .
METHODS	Patients with a single 1 to 2 cm radiolucent lower calyceal renal stone who underwent treatment between January 2012 and May 2013 were included in study .
METHODS	They were randomized to shock wave lithotripsy , retrograde intrarenal surgery and miniperc groups .
METHODS	Patient demographic profiles , success and re-treatment rates , auxiliary procedures and complications were analyzed .
RESULTS	A total of 45 patients were enrolled in each of the shock wave lithotripsy , retrograde intrarenal surgery and miniperc groups .
RESULTS	Three , 2 and 4 patients , respectively , were excluded from final analysis due to a matrix stone diagnosis .
RESULTS	Mean procedure and fluoroscopy times were significantly greater in the miniperc group than in the other groups .
RESULTS	Hospital stay ( 3.1 days vs 3.1 hours and 1.3 days , p = 0.01 ) and the blood transfusion rate ( 13.3 % vs 0 % and 0 % , p = 0.03 ) were significantly higher for miniperc vs shock wave lithotripsy and retrograde intrarenal surgery , respectively .
RESULTS	The re-treatment rate ( 63.4 % vs 2.1 % and 2.2 % , p < 0.001 ) and the auxiliary procedure rate ( 20.2 % vs 8.8 % and 6.6 % , p = 0.02 ) were significantly greater for shock wave lithotripsy than for retrograde intrarenal surgery and miniperc , respectively .
RESULTS	The 3-month stone-free rate of shock wave lithotripsy , retrograde intrarenal surgery and miniperc was 73.8 % ( 31 of 42 patients ) , 86.1 % ( 37 of 43 ) and 95.1 % ( 39 of 41 ) , respectively ( p = 0.01 ) .
CONCLUSIONS	Miniperc and retrograde intrarenal surgery were more effective than shock wave lithotripsy to treat 1 to 2 cm radiolucent lower calyceal renal calculi in terms of a better stone-free rate , and lesser auxiliary and re-treatment rates .
CONCLUSIONS	However , miniperc resulted in more complications , greater operative time and radiation exposure , and a longer hospital stay .

###25419180
BACKGROUND	Blood biomarkers are increasingly used to diagnose , guide therapy in , and risk-stratify community-acquired pneumonia ( CAP ) patients in emergency departments ( EDs ) .
BACKGROUND	How pre-analytic factors affect these markers ' initial levels in this population is unknown .
METHODS	In this secondary analysis of consecutive ED patients with CAP from a large multicentre antibiotic stewardship trial , we used adjusted multivariate regression models to determine the magnitude and statistical significance of differences in mean baseline concentrations of five biomarkers ( procalcitonin [ PCT ] , C-reactive protein [ CRP ] , white blood cells count [ WBC ] , proadrenomedullin [ ProADM ] , copeptin ) associated with six pre-analytic factors ( antibiotic or corticosteroid pretreatment , age , gender , chronic renal failure or chronic liver insufficiency ) .
RESULTS	Of 925 CAP patients ( median age 73 years , 58.8 % male ) , 25.5 % had antibiotic pretreatment , 2.4 % , corticosteroid pretreatment , 22.3 % , chronic renal failure , 2.4 % chronic liver insufficiency .
RESULTS	Differences associated with pre-analytic factors averaged 6.1 % 4.6 % ; the three largest statistically significant changes ( 95 % confidence interval ) were : PCT , +14.2 % ( +2.1 % to +26.4 % , p = 0.02 ) with liver insufficiency ; ProADM , +13.2 % ( +10.2 % to +16.1 % , p < 0.01 ) with age above median ; CRP , -12.8 % ( -25.4 % to -0.2 % , p = 0.05 ) with steroid pretreatment .
RESULTS	In post hoc sensitivity analyses , reclassification statistics showed that these factors did not result in significant changes of biomarker levels across clinically used cut-off ranges .
CONCLUSIONS	Despite statistically significant associations of some pre-analytic factors and biomarker levels , a clinically relevant influence seems unlikely .
CONCLUSIONS	Our observations reinforce the concept of using biomarkers in algorithms with widely-separated cut-offs and overruling criteria considering the entire clinical picture .
BACKGROUND	Identifier ISRCTN95122877 .

###25701866
BACKGROUND	Malaria prophylaxis is recommended for persons with sickle cell disease ( SCD ) , but the value of this has been questioned .
BACKGROUND	The aim of this study was to find out whether intermittent preventive treatment ( IPT ) with a fixed-dose combination of mefloquine-artesunate ( MQAS ) or sulfadoxine-pyrimethamine plus amodiaquine ( SPAQ ) was more effective than daily proguanil for malaria prevention in subjects with SCD .
METHODS	Patients with SCD were randomized to receive daily treatment with proguanil or IPT with either MQAS or SPAQ once every 2 months at routine clinic visits .
METHODS	Patients were followed up for 14 months .
RESULTS	A total of 270 patients with SCD were studied , with 90 in each group .
RESULTS	Adherence to the IPT regimens was excellent , but 57 % of patients took < 75 % of their daily doses of proguanil .
RESULTS	IPT was well tolerated ; the most common side effects were vomiting and abdominal pain .
RESULTS	Protective efficacy against malaria , compared with daily proguanil , was 61 % ( 95 % confidence interval , 3 % -84 % ) for MQAS and 36 % ( 40 % -70 % ) for SPAQ .
RESULTS	There were fewer outpatient illness episodes in children who received IPT than those who received proguanil .
CONCLUSIONS	IPT with MQAS administered to patients with SCD during routine clinic visits was well tolerated and more effective in preventing malaria than daily prophylaxis with proguanil .
BACKGROUND	NCT01319448 and ISRCTN46158146 .

###24508285
OBJECTIVE	To compare the clinical effectiveness of a newly developed cognitive behavioural self-management manual delivered by specialist heart failure nurses or the same programme followed by the patient on their own , in terms of readmissions/admissions to hospital for any reason within a 12 month period , patient health related quality of life , self-management and carer quality of life .
METHODS	Pragmatic , open parallel group , randomised controlled trial .
METHODS	Open access heart failure diagnostic clinics and primary care .
METHODS	260 patients with a definitive diagnosis of symptomatic heart failure ( LVSD ) as defined by ECHO , clinical diagnosis or coronary angiography were eligible for the study .
METHODS	A newly developed nurse facilitated , cognitive behavioural self-management programme was developed and was delivered either by a heart failure nurse or by the patient on their own .
METHODS	Patient admission/readmission to hospital for any reason within a 12 month period following randomisation .
METHODS	Secondary outcomes were : participant health related quality of life as measured by the Minnesota Living with Heart Failure questionnaire , the Hospital , Anxiety and Depression Scale , the European self-care form .
RESULTS	There was no evidence of a difference between the groups in whether or not a patient was re-admitted to hospital during the 12 month follow-up period ( p = 0.66 ) .
RESULTS	There was no evidence of a difference between the treatment groups in the mean MLHF scores over time ( p = 0.768 ) , the European self-care questionnaire ( p = 0.340 ) or the mean HAD anxiety score ( p = 0.786 ) .
RESULTS	However , when adjusted for baseline scores the self-management group had a statistically significant higher HADS depression score at 12 months ( p = 0.003 ) .
CONCLUSIONS	There was no evidence of a difference in admissions/readmission to hospital between patients who undertook a brief heart failure self-management programme facilitated by a specialist heart failure nurse and those also receiving care from a specialist nurse who followed the programme on their own .
BACKGROUND	This trial is registered as ISRCTN84692046 .

###24768330
OBJECTIVE	For advanced gastrointestinal stromal tumour ( GIST ) patients who are responding to imatinib mesylate , the role of surgery has not been formally demonstrated .
OBJECTIVE	This multicenter randomised controlled trial was designed to assess whether surgery to treat residual disease for patients with recurrent/metastatic GISTs responding to imatinib mesylate ( IM ) improved progression free survival ( PFS ) compared with IM treatment alone .
METHODS	Between 3 and 12months after starting IM for recurrent/metastatic GISTs , eligible patients were randomised to two arms : Arm A ( surgery for residual disease ) and Arm B ( IM treatment alone ) .
METHODS	In Arm A ( 19pts ) , surgery was performed to remove residual macroscopic lesions as completely as possible , and IM treatment continued after surgery .
METHODS	In Arm B ( 22pts ) , IM was given alone at a dose of 400mg per day until disease progression .
METHODS	The primary end-point was PFS measured from the date IM started .
METHODS	This study was registered in the ChiCTR registry with the ID number ChiCTR-TRC-00000244 .
RESULTS	This randomised trial was closed early due to poor accrual .
RESULTS	Only 41 patients were enrolled as opposed to 210 patients planned .
RESULTS	2-year PFS was 88.4 % in the surgery arm and 57.7 % in the IM-alone arm ( P = 0.089 ) .
RESULTS	Median overall survival ( mOS ) was not reached in the surgery arm and 49months in patients with IM-alone arm ( P = 0.024 ) .
CONCLUSIONS	While no significant differences were observed in the two arms , this study suggests that surgical removal of the metastatic lesion may improve the outcome of advanced GIST patients and should stimulate additional research on this topic .

###24917354
OBJECTIVE	The aim of this study was to compare the effects of low-volume , high-intensity aerobic interval training ( HAIT ) on maximal oxygen consumption ( VOmax ) , left ventricular ( LV ) mass , and heart rate recovery ( HRR ) with high-volume , moderate-intensity continuous aerobic training ( CAT ) in sedentary adults .
METHODS	Twenty-four healthy but sedentary male adults ( aged 29.2 7.2 years ) participated in an 8-week , 3-day a week , supervised exercise intervention .
METHODS	They were randomly assigned to either HAIT ( 18 min , 180 kcal per exercise session ) or CAT ( 45 min , 360 kcal ) .
METHODS	VOmax , LV mass ( 3T-MRI ) , and HRR at 1 min ( HRR-1 ) and 2 min ( HRR-2 ) after maximal exercise were measured pre - and post-intervention .
RESULTS	Changes in VOmax during the 8-week intervention were significant ( P < 0.01 ) in both groups ( HAIT , 8.7 3.2 ml kg ( -1 ) min ( -1 ) , 22.4 8.9 % ; CAT , 5.5 2.8 ml kg ( -1 ) min ( -1 ) , 14.7 9.5 % ) , while the VOmax improvement in HAIT was greater ( P = 0.02 ) than in CAT .
RESULTS	LV mass in HAIT increased ( 5.1 8.4 g , 5.7 9.1 % , P = 0.05 ) , but not in CAT ( 0.9 7.8 g , 1.1 8.4 % , P = 0.71 ) .
RESULTS	While changes in HRR-1 were not significant in either group , change in HRR-2 for HAIT ( 9.5 6.4 bpm , 19.0 16.0 % , P < 0.01 ) was greater ( P = 0.03 ) than for CAT ( 1.6 10.9 bpm , 3.9 16.2 % , P = 0.42 ) .
CONCLUSIONS	This study suggests that HAIT has potential as a time-efficient training mode to improve cardiorespiratory capacity and autonomic nervous system function in sedentary adults .

###24646343
OBJECTIVE	To investigate short - and long-term effects of real-time monitoring medication use combined with short message service ( SMS ) reminders for missed doses on refill adherence to oral anti-diabetic medication .
METHODS	A randomized controlled trial with two intervention groups and one control group involving 161 participants with Type2 diabetes with suboptimal adherence .
METHODS	For 6months , participants in the SMS group ( n = 56 ) were monitored and received SMS reminders if they missed their medication .
METHODS	Participants in the non-SMS group ( n = 48 ) were only monitored .
METHODS	The control group ( n = 57 ) was not exposed to any intervention .
METHODS	Primary outcome measure was refill adherence to oral anti-diabetic medication .
METHODS	Multi-level regression analyses were performed to examine intervention effects on adherence between and within groups after 1 and 2years of follow-up .
RESULTS	At baseline , mean refill adherence was comparable between the groups .
RESULTS	After 1year , adherence in the SMS group was significantly higher than in the control group ( 79.5 % vs. 64.5 % ; P < 0.001 ) and showed a significant improvement from baseline ( +16.3 % ; P < 0.001 ) .
RESULTS	Mean adherence in the non-SMS group reached 73.1 % ( +7.3 % ; P < 0.05 ) , but did not differ from the control group ( P = 0.06 ) .
RESULTS	After 2years , the improved adherence in the SMS group persisted and remained significantly higher than in the control group ( 80.4 % vs. 68.4 % ; P < .01 ) , contrary to the non-SMS group whose adherence approached baseline level again ( 65.5 % ) .
CONCLUSIONS	This study shows the long-term effectiveness of real-time medication monitoring combined with SMS reminders in improving refill adherence .
CONCLUSIONS	This new reminder system can strengthen the self-management of people with diabetes .

###24299607
BACKGROUND	Rheumatoid arthritis ( RA ) , as a common systemic inflammatory autoimmune disease , affects approximately 1 in 100 individuals .
BACKGROUND	Effective treatment for RA is not yet available because current research does not have a clear understanding of the etiology and pathogenesis of RA .
BACKGROUND	Xinfeng Capsule , a patent Chinese herbal medicine , has been used in the treatment of RA in recent years .
BACKGROUND	Despite its reported clinical efficacy , there are no large-sample , multicenter , randomized trials that support the use of Xinfeng Capsule for RA .
BACKGROUND	Therefore , we designed a randomized , double-blind , multicenter , placebo-controlled trial to assess the efficacy and safety of Xinfeng Capsule in the treatment of RA .
METHODS	This is a 12-week , randomized , placebo-controlled , double-blind , multicenter trial on the treatment of RA .
METHODS	The participants will be randomly assigned to the experimental group and the control group at a ratio of 1:1 .
METHODS	Participants in the experimental group will receive Xinfeng Capsule and a pharmaceutical placebo ( imitation leflunomide ) .
METHODS	The control group will receive leflunomide and an herbal placebo ( imitation Xinfeng Capsule ) .
METHODS	The American College of Rheumatology ( ACR ) Criteria for RA will be used to measure the efficacy of the Xinfeng Capsule .
METHODS	The primary outcome measure will be the percentage of study participants who achieve an ACR 20 % response rate ( ACR20 ) , which will be measured every 4 weeks after randomization .
METHODS	Secondary outcomes will include the ACR50 and ACR70 responses , the side effects of the medications , the Disease Activity Score 28 , RA biomarkers , quality of life , and X-rays of the hands and wrists .
METHODS	The first four of the secondary outcomes will be measured every 4 weeks and the others will be measured at baseline and after 12 weeks of treatment .
CONCLUSIONS	The result of this trial will help to evaluate whether Xinfeng Capsule is effective and safe in the treatment of RA .
BACKGROUND	This trial has been registered in ClinicalTrials.gov .
BACKGROUND	The identifier is NCT01774877 .

###24355450
BACKGROUND	Despite rehabilitation programmes offered to all patients with newly diagnosed type 2 diabetes in Denmark , a number of patients either never accomplish good diabetes regulation or the regulation deteriorates with time .
BACKGROUND	Therefore , new approaches are needed .
BACKGROUND	The aim of the present study is to examine whether telemedicine conferences with a nurse can contribute to achieving good diabetes control among patients with poorly regulated type 2 diabetes .
METHODS	A total of 165 patients with type 2 diabetes who have formerly undergone a rehabilitation programme are randomized to either telemedicine intervention or usual care .
METHODS	The intervention lasts for 32 weeks and consists of monthly videoconferences with a nurse from a health-care centre as an add-on to usual care .
METHODS	Blood sugar , blood pressure and weight are regularly self-monitored and measurements are automatically transferred to a database .
METHODS	Glycaemic control ( HbA1c level ) is examined at baseline , 16 weeks , 32 weeks and 58 weeks ( six months post intervention ) .
METHODS	Blood pressure , weight , waist/hip ratio , quality of life , physical activity , lipids , creatinine and haemoglobin are examined at baseline and after 32 weeks .
CONCLUSIONS	The study will examine whether telemedicine technology can contribute to achieving good diabetes regulation .
BACKGROUND	The City of Copenhagen and the Prevention Fund of the Capital Region of Denmark funded the project .
BACKGROUND	Also `` Smedemester Niels Hansen og Hustru Johanne F. Frederiksens Legat '' has supported the study .
BACKGROUND	ClinicalTrials.gov registration number : NCT01688778 .

###25056240
BACKGROUND	Different aspiration techniques to retrieve bronchoalveolar lavage fluid ( BALF ) affect sample quality in healthy dogs .
BACKGROUND	Studies evaluating these techniques in dogs with respiratory disease are lacking .
OBJECTIVE	To compare sample quality of BALF acquired by manual aspiration ( MA ) and suction pump aspiration ( SPA ) .
METHODS	Eighteen client-owned dogs with respiratory disease .
METHODS	Randomized , blinded prospective clinical trial .
METHODS	Manual aspiration was performed with a 35-mL syringe attached directly to the bronchoscope biopsy channel and SPA was performed with a maximum of 50 mmHg negative pressure applied to the bronchoscope suction valve using the suction trap connection .
METHODS	Both aspiration techniques were performed in each dog on contralateral lung lobes , utilizing 2 mL/kg lavage volumes per site .
METHODS	Samples of BALF were analyzed by percentage of retrieved infusate , total nucleated cell count ( TNCC ) , differential cell count , semiquantitative assessment of slide quality , and diagnosis score .
METHODS	Data were compared by paired Student 's t-test , Wilcoxon signed-rank test , chi-squared test , and ANOVA .
METHODS	Cohen 's kappa coefficient was used to assess agreement .
RESULTS	The percentage of retrieved BALF ( P = .001 ) was significantly higher for SPA than MA .
RESULTS	Substantial agreement was found between cytologic classification of BALF obtained with MA and SPA ( kappa = 0.615 ) .
RESULTS	There was no significant difference in rate of definitive diagnosis achieved with cytologic assessment between techniques ( P = .78 ) .
CONCLUSIONS	Suction pump aspiration , compared to MA , improved BALF retrieval , but did not significantly affect the rate of diagnostic success of bronchoalveolar lavage ( BAL ) in dogs with pulmonary disease .

###25673440
BACKGROUND	As a Chinese Traditional Medicine product , Kuntai capsule could improve the peri-menopausal symptoms in postmenopausal women .
BACKGROUND	But it is still not clear whether Kuntai capsule has a good effect on alleviating peri-menopausal symptoms induced by gonadotropin releasing hormone agonist ( GnRH-a ) treatment .
BACKGROUND	The purpose of this study was to investigate the clinical effectiveness and safety of Kuntai capsule , on peri-menopausal symptoms in endometriosis ( EMS ) patients , with postoperative GnRH-a treatment .
METHODS	Ninety EMS ovarian cyst women with postoperative GnRH-a administration were enrolled in the study , and were randomly divided into Kuntai group , Tibolone group , or blank Control group .
METHODS	The therapeutic strategy in Kuntai group was 4 Kuntai capsules tid , po for 12 weeks after the first GnRH-a injection , while Tibolone 2.5 mg qd , po for 12 weeks in Tibolone group .
METHODS	There was no drug addition in Control group .
METHODS	Climacteric complaints were evaluated by Kupperman menopausal index ( KMI ) and hot flash/sweating score .
METHODS	Liver and renal functions , lipid profile , serum sex hormone levels and endometrial thickness were measured , and the frequency of adverse events in Kuntai and Tibolone groups was recorded .
RESULTS	( 1 ) Before GnRH-a therapy , the baseline parameter results were comparable in the three groups ( P > 0.05 ) .
RESULTS	( 2 ) After GnRH-a therapy , KMI and hot flash/sweating scores in all the three groups increased significantly ( P < 0.05 ) .
RESULTS	At the 4 th week after GnRH-a therapy , KMI and hot flash/sweating score results were as follows : Control group > Kuntai group > Tibolone group ( P < 0.05 ) ; at the 8 th and 12 th week after GnRH-a therapy , KMI and hot flash/sweating score in Control group were significantly higher than the other two groups ( P < 0.05 ) , and no significant difference was identified between Kuntai and Tibolone group ( P > 0.05 ) .
RESULTS	( 3 ) No statistical change took place in the liver and renal functions and lipid profile in all the three groups after the treatment ( P > 0.05 ) .
RESULTS	( 4 ) The posttherapeutic serum follicle-stimulating hormone ( FSH ) , luteinizing hormone ( LH ) and estradiol ( E2 ) level and endometrial thickness decreased significantly in all the three groups ( P < 0.05 ) .
RESULTS	After therapy , serum E2 level in Tibolone group was obviously higher than the other two groups ( P < 0.05 ) , while FSH and LH levels were obviously lower ( P < 0.05 ) .
RESULTS	( 5 ) The incidence of vaginal bleeding , breast distending pain in Tibolne group was obviously higher than Kuntai group ( P < 0.05 ) .
CONCLUSIONS	Kuntai capsule is effective on the peri-menopausal symptoms induced by postoperative GnRH-a administration to EMS patients , although its clinical effect might be a few weeks later than Tibolone .
CONCLUSIONS	Kuntai capsule might be a little safer than Tibolone tablet .

###26054175
OBJECTIVE	The purpose of this clinical investigation was to evaluate the effectiveness of a marketed whitening chewing gum compared to a no-gum control in preventing the formation of extrinsic stains on the teeth of stain-forming subjects when chewed over a 12-week period of regular unsupervised use in conjunction with daily tooth brushing .
METHODS	This was a single-center , examiner-blind , randomized , 12-week crossover clinical trial .
METHODS	Stain-forming ( after smoking or drinking coffee or tea ) adults , starting with a stain-free baseline , either chewed the test gum ( Orbit White ) unsupervised four times per day , 15 minutes/chew , or used no gum along with daily brushing with a commercially available toothbrush and dentifrice for 12 weeks .
METHODS	At the crossover , all procedures were repeated with subjects assigned the opposite treatment .
METHODS	Extrinsic stain was measured at six and 12 weeks by both the Lobene Stain Index ( LSI ) and the Modified Lobene Stain Index ( MLSI ) using separate experienced examiners .
RESULTS	After 12 weeks , LSI stain scores showed a significant 25 % reduction ( p = 0.0008 ) in new stain formation for subjects using the test chewing gum along with tooth brushing versus tooth brushing alone ( no-gum control ) .
RESULTS	The corresponding MLSI stain scores demonstrated a 36 % reduction ( p < 0.0001 ) in the formation of extrinsic stain on the teeth .
CONCLUSIONS	The overall findings of this clinical study demonstrated that regular use of Orbit White chewing gum , soon after smoking or drinking coffee or tea , will supplement daily tooth brushing in preventing unsightly stains from forming on the anterior teeth compared to brushing alone .

###25842575
OBJECTIVE	To evaluate the effectiveness and safety of cervical arthroplasty and anterior cervical discectomy fusion methods .
METHODS	The randomised clinical trial was conducted at the neurosurgical clinic of University of Harran , Turkey , between February 2009 and January 2010 .
METHODS	The patients had single level disc disorder between C4-C7 levels .
METHODS	Before surgery , all of the patients had taken medical treatment with no improvement .
METHODS	Surgery was conducted with anterior approach , and disc prosthesis or polyetheretherketone cage for fusion were applied after patients were randomly divided into two groups .
METHODS	For preoperative and postoperative clinical evaluations Neck Disability Index and Visual Analogue Scale were used .
METHODS	Surgical results were evaluated according to Odom 's criterion , and ` excellent ' and ` good ' results were accepted as successful .
METHODS	P < 0.05 was taken as statistically significant .
RESULTS	Of the 42 patients in the study , 23 ( 54.76 % ) were treated with Anterior Cervical Discectomy and Fusion , and 19 ( 45.23 % ) with Cervical Disc Arthroplasty .
RESULTS	There were no statistical differences between postoperative mean Visual Analogue Scale score ( p < 0.86 ) and Neck Disability Index scores ( p < 0.11 ) in the two groups .
RESULTS	Average decrease in lordosis angle was 1.2 degree in Arthroplasty group , while it was 1 degree in the Fusion group .
RESULTS	Postoperative adjacent segment degeneration was not detected in either group .
CONCLUSIONS	Anterior Cervical Discectomy and Fusion , and Cervical Disc Arthroplasty are safe and successful methods for the treatment of single level cervical disc disease .
CONCLUSIONS	Although the latter is a relatively new technique performed with increased frequency , but its superiority is still uncertain .

###24443305
OBJECTIVE	The objective of study was to develop an accurate and reproducible HPLC method for determination of piracetam in human plasma and to evaluate pharmacokinetic parameters of 800 mg piracetam .
METHODS	A simple , rapid , accurate , precise and sensitive high pressure liquid chromatography method has been developed and subsequently validated for determination of piracetam .
METHODS	This study represents the results of a randomized , single-dose and single-period in 18 healthy male volunteers to assess pharmacokinetic parameters of 800 mg piracetam tablets .
METHODS	Various pharmacokinetic parameters were determined from plasma for piracetam and found to be in good agreement with previous reported values .
METHODS	The data was analyzed by using Kinetica version 4.4 according to non-compartment model of pharmacokinetic analysis and after comparison with previous studies , no significant differences were found in present study of tested product .
RESULTS	The major pharmacokinetic parameters for piracetam were as follows : t1/2 was ( 4.40 0.179 ) h ; Tmax value was ( 2.33 0.105 ) h ; Cmax was ( 14.53 0.282 ) g/mL ; the AUC ( 0 - ) was ( 59.19 4.402 ) gh/mL .
RESULTS	AUMC ( 0 - ) was ( 367.23 38.96 ) g. ( h ) ( 2 ) / mL ; Ke was ( 0.16 0.006 ) h ; MRT was ( 5.80 0.227 ) h ; Vd was ( 96.36 8.917 L ) .
CONCLUSIONS	A rapid , accurate and precise high pressure liquid chromatography method was developed and validated before the study .
CONCLUSIONS	It is concluded that this method is very useful for the analysis of pharmacokinetic parameters , in human plasma and assured the safety and efficacy of piracetam , can be effectively used in medical practice .

###25142566
OBJECTIVE	To evaluate the efficacy of mindfulness meditation for the treatment of chronic insomnia .
METHODS	Three-arm , single-site , randomized controlled trial .
METHODS	Academic medical center .
METHODS	Fifty-four adults with chronic insomnia .
METHODS	Participants were randomized to either mindfulness-based stress reduction ( MBSR ) , mindfulness-based therapy for insomnia ( MBTI ) , or an eight-week self-monitoring ( SM ) condition .
RESULTS	Patient-reported outcome measures were total wake time ( TWT ) from sleep diaries , the pre-sleep arousal scale ( PSAS ) , measuring a prominent waking correlate of insomnia , and the Insomnia Severity Index ( ISI ) to determine remission and response as clinical endpoints .
RESULTS	Objective sleep measures were derived from laboratory polysomnography and wrist actigraphy .
RESULTS	Linear mixed models showed that those receiving a meditation-based intervention ( MBSR or MBTI ) had significantly greater reductions on TWT minutes ( 43.75 vs 1.09 ) , PSAS ( 7.13 vs 0.16 ) , and ISI ( 4.56 vs 0.06 ) from baseline-to-post compared to SM .
RESULTS	Post hoc analyses revealed that each intervention was superior to SM on each of the patient-reported measures , but no significant differences were found when comparing MBSR to MBTI from baseline-to-post .
RESULTS	From baseline to 6-month follow-up , MBTI had greater reductions in ISI scores than MBSR ( P < 0.05 ) , with the largest difference occurring at the 3-month follow-up .
RESULTS	Remission and response rates in MBTI and MBSR were sustained from post-treatment through follow-up , with MBTI showing the highest rates of treatment remission ( 50 % ) and response ( 78.6 % ) at the 6-month follow-up .
CONCLUSIONS	Mindfulness meditation appears to be a viable treatment option for adults with chronic insomnia and could provide an alternative to traditional treatments for insomnia .
BACKGROUND	Mindfulness-Based Approaches to Insomnia : clinicaltrials.gov , identifier : NCT00768781 .

###26289684
OBJECTIVE	To determine the effect of nurse-implemented transitional care ( TC ) on readmission and mortality rates in Chinese individuals with chronic heart failure ( CHF ) in Hong Kong .
METHODS	Single-center randomized controlled trial of TC versus usual care ( UC ) .
METHODS	University-affiliated hospital in Hong Kong .
METHODS	Hospitalized Chinese individuals with CHF ( N = 178 ; aged 78.6 6.9 , 45 % male ) .
METHODS	The TC group received a predischarge visit , two home visits , and then regular telephone calls over 9 months to provide self-care education and support , optimized health surveillance , and facilitation in use of community services .
METHODS	Primary endpoints were event-free survival , all-cause hospital readmission , and mortality during the 9-month follow-up .
METHODS	Secondary endpoints were length of hospital stay , self-care , and health-related quality of life ( HRQL ) .
METHODS	Data were analyzed using survival analysis and generalized estimating equations , following an intention-to-treat principle .
RESULTS	Survival analysis indicated no significant differences in event-free survival , hospital readmission , or mortality between the TC and UC groups , although the TC group had a lower hospital readmission rate at 6 weeks ( 8.1 % vs 16.3 % , P = .048 ) and lower mortality at 9 months ( 4.1 % vs 13.8 % , P = .03 ) .
RESULTS	The TC group also had a shorter hospital stay ( P = .006 ) and significantly better self-care and HRQL .
RESULTS	Because of attrition , sensitivity analyses were conducted to examine whether the intention-to-treat assumption affected the results .
RESULTS	Per-protocol population analyses ( hazard ratio ( HR ) = 0.40 , 95 % confidence interval ( CI ) = 0.17-0 .93 ) and worst-case-scenario analysis ( HR = 0.44 , 95 % CI = 0.25-0 .77 ) suggested a lower mortality risk in the TC group .
CONCLUSIONS	The translation of individual-centered nurse-implemented TC to the Chinese culture and healthcare context of Hong Kong appears beneficial .

###25498484
BACKGROUND	To investigate the mechanism of action of tranexamic acid ( TXA ) in bleeding trauma patients , we examined the timing of its effect on mortality .
BACKGROUND	We hypothesised that if TXA reduces mortality by decreasing blood loss , its effect should be greatest on the day of the injury when bleeding is most profuse .
BACKGROUND	However , if TXA reduces mortality via an anti-inflammatory mechanism its effect should be greater over the subsequent days .
METHODS	Exploratory analysis , including per-protocol analyses , of data from the CRASH-2 trial , a randomised placebo controlled trial of the effect of TXA on mortality in 20,211 trauma patients with , or at risk of , significant bleeding .
METHODS	We examined hazard ratios ( HR ) and 95 % confidence intervals for all-cause mortality , deaths due to bleeding and non-bleeding deaths , according to the day since injury .
METHODS	The CRASH-2 trial is registered as ISRCTN86750102 and ClinicalTrials.gov NCT00375258 .
RESULTS	The effect of TXA on mortality is greatest for deaths occurring on the day of the injury ( HR all-cause mortality = 0.83 , 0.73 to 0.93 ) .
RESULTS	This survival benefit is only evident in patients in whom treatment is initiated within 3 hours of their injury ( HR 3 hours = 0.78 , 0.68 to 0.90 ; HR > 3 hours = 1.02 , 0.76 to 1.36 ) .
RESULTS	Initiation of TXA treatment within 3 hours of injury reduced the hazard of death due to bleeding on the day of the injury by 28 % ( HR = 0.72 , 0.60 to 0.86 ) .
RESULTS	TXA treatment initiated beyond 3 hours of injury appeared to increase the hazard of death due to bleeding , although the estimates were imprecise .
CONCLUSIONS	Early administration of tranexamic acid appears to reduce mortality primarily by preventing exsanguination on the day of the injury .

###24992939
BACKGROUND	Photoperiod is known to cause physiological changes in seasonal mammals , including changes in body weight , physical activity , reproductive status , and adipose tissue gene expression in several species .
BACKGROUND	The objective of this study was to determine the effects of day length on the adipose transcriptome of cats as assessed by RNA sequencing .
BACKGROUND	Ten healthy adult neutered male domestic shorthair cats were used in a randomized crossover design study .
BACKGROUND	During two 12-wk periods , cats were exposed to either short days ( 8 hr light :16 hr dark ) or long days ( 16 hr light :8 hr dark ) .
BACKGROUND	Cats were fed a commercial diet to maintain baseline body weight to avoid weight-related bias .
BACKGROUND	Subcutaneous adipose biopsies were collected at wk 12 of each period for RNA isolation and sequencing .
RESULTS	A total of 578 million sequences ( 28.9 million/sample ) were generated by Illumina sequencing .
RESULTS	A total of 170 mRNA transcripts were differentially expressed between short day - and long day-housed cats .
RESULTS	89 annotated transcripts were up-regulated by short days , while 24 annotated transcripts were down-regulated by short days .
RESULTS	Another 57 un-annotated transcripts were also different between groups .
RESULTS	Adipose tissue of short day-housed cats had greater expression of genes involved with cell growth and differentiation ( e.g. , myostatin ; frizzled-related protein ) , cell development and structure ( e.g. , cytokeratins ) , and protein processing and ubiquitination ( e.g. , kelch-like proteins ) .
RESULTS	In contrast , short day-housed cats had decreased expression of genes involved with immune function ( e.g. , plasminogen activator inhibitor 1 ; chemokine ( C-C motif ) ligand 2 ; C-C motif chemokine 5 ; T-cell activators ) , and altered expression of genes associated with carbohydrate and lipid metabolism .
CONCLUSIONS	Collectively , these gene expression changes suggest that short day housing may promote adipogenesis , minimize inflammation and oxidative stress , and alter nutrient metabolism in feline adipose tissue , even when fed to maintain body weight .
CONCLUSIONS	Although this study has highlighted molecular mechanisms contributing to the seasonal metabolic changes observed in cats , future research that specifically targets and studies these biological pathways , and the physiological outcomes that are affected by them , is justified .

###25160533
OBJECTIVE	The purpose of this study was to investigate the effect of lutein on systemic complement activation in elderly individuals .
METHODS	Seventy patients with signs of early age-related macular degeneration ( AMD ) were included in this study .
METHODS	All subjects were randomly assigned to receive a 10 mg daily dose of lutein or a placebo for a time period of 1 year .
METHODS	EDTA blood was collected before and at various time-points during the study ( 0 , 4 , 8 and 12 months ) .
METHODS	The plasma level of the soluble complement membrane attack complex sC5b-9 was measured by ELISA .
RESULTS	We found a significant 1.1 ng/ml monthly decrease in the plasma sC5b-9 concentration in the lutein group ( p < 0.001 ) , resulting in a decrease from 60.3 ng/ml at baseline to 46.3 ng/ml at 12 months .
RESULTS	For the placebo group , we found a significant 0.6 ng/ml monthly increase in plasma sC5b-9 concentration ( p = 0.001 ) , resulting in an increase from 51.6 ng/ml at baseline to 58.4 ng/ml at 12 months .
CONCLUSIONS	Lutein supplementation inhibits the systemic activation of the complement system , which provides further functional evidence for the reported beneficial effects of this carotenoid in the management of AMD .

###24391801
BACKGROUND	Tuberculosis ( TB ) is common among HIV-infected individuals in many resource-limited countries and has been associated with poor survival .
BACKGROUND	We evaluated morbidity and mortality among individuals first starting antiretroviral therapy ( ART ) with concurrent active TB or other AIDS-defining disease using data from the `` Prospective Evaluation of Antiretrovirals in Resource-Limited Settings '' ( PEARLS ) study .
METHODS	PARTICIPANTS WERE CATEGORIZED RETROSPECTIVELY INTO THREE GROUPS ACCORDING TO PRESENCE OF ACTIVE CONFIRMED OR PRESUMPTIVE DISEASE AT ART INITIATION : those with pulmonary and/or extrapulmonary TB ( `` TB '' group ) , those with other non-TB AIDS-defining disease ( `` other disease '' ) , or those without concurrent TB or other AIDS-defining disease ( `` no disease '' ) .
METHODS	Primary outcome was time to the first of virologic failure , HIV disease progression or death .
METHODS	Since the groups differed in characteristics , proportional hazard models were used to compare the hazard of the primary outcome among study groups , adjusting for age , sex , country , screening CD4 count , baseline viral load and ART regimen .
RESULTS	31 of 102 participants ( 30 % ) in the `` TB '' group , 11 of 56 ( 20 % ) in the `` other disease '' group , and 287 of 1413 ( 20 % ) in the `` no disease '' group experienced a primary outcome event ( p = 0.042 ) .
RESULTS	This difference reflected higher mortality in the TB group : 15 ( 15 % ) , 0 ( 0 % ) and 41 ( 3 % ) participants died , respectively ( p < 0.001 ) .
RESULTS	The adjusted hazard ratio comparing the `` TB '' and `` no disease '' groups was 1.39 ( 95 % confidence interval : 0.93-2 .10 ; p = 0.11 ) for the primary outcome and 3.41 ( 1.72-6 .75 ; p < 0.001 ) for death .
CONCLUSIONS	Active TB at ART initiation was associated with increased risk of mortality in HIV-1 infected patients .

###25233646
OBJECTIVE	To compare the clinical efficacy in the treatment of post-stroke shoulder-hand syndrome between floating-needle therapy and conventional acupuncture on the basis of rehabilitation training .
METHODS	One hundred cases of post-stroke shoulder-hand syndrome were randomized into a floating-needle group and an acupuncture group , 50 cases in each one .
METHODS	The passive and positive rehabilitation training was adopted in the two groups .
METHODS	Additionally , in the floating-needle group , the floating-needle therapy was used .
METHODS	The needle was inserted at the site 5 to 10 cm away from myofasical trigger point ( MTrP ) , manipulated and scattered subcutaneously , for 2 min continuously .
METHODS	In the acupuncture group , the conventional acupuncture was applied at Jianqian ( EX-UE ) , Jianyu ( LI 15 ) , Jianliao ( TE 14 ) , etc. .
METHODS	The treatment was given once every two days , 3 times a week , and 14 days of treatment were required .
METHODS	The shoulder hand syndrome scale ( SHSS ) , the short form McGill pain scale ( SF-MPQ ) and the modified Fugl-Meyer motor function scale ( FMA ) were used to evaluate the damage severity , pain and motor function of the upper limbs before and after treatment in the two groups .
METHODS	The clinical efficacy was compared between the two groups .
RESULTS	SHSS score , SF-MPQ score and FMA score were improved significantly after treatment in the two groups ( all P < 0.01 ) , and the improvements in the floating-needle group were superior to those in the acupuncture group ( all P < 0.05 ) .
RESULTS	The total effective rate was 94.0 % ( 47/50 ) in the floating-needle group , which was better than 90.0 % ( 45/50 ) in the acupuncture group ( P < 0.05 ) .
CONCLUSIONS	The floating-needle therapy combined with rehabilitation training achieves a satisfactory efficacy on post-stroke shoulder-hand syndrome , which is better than the combined therapy of conventional acupuncture and rehabilitation training .

###25494297
OBJECTIVE	To prospectively determine the feasibility of low-iodine-load and low-tube-voltage computed tomographic ( CT ) angiographic imaging of the kidney and to evaluate the opacification and image quality compared with moderate-iodine-load and high-iodine-load techniques .
METHODS	Institutional review board approval and written informed consent was obtained .
METHODS	One hundred thirteen consecutive patients randomly underwent three protocols for dual-phase renal CT angiographic imaging : high-iodine-load ( 600 mg iodine per kilogram of body weight at 120 kVp ) ; moderate-iodine-load ( 400 mg iodine per kilogram of body weight at 80 kVp ) ; and low-iodine-load ( contrast agent injection initially prepared at 400 mg iodine per kilogram of body weight but stopped immediately after bolus-tracking trigger at 80 kVp ) scanning .
METHODS	CT numbers of vessels and kidneys were measured .
METHODS	CT numbers and signal-to-noise ratio ( SNR ) were compared with one-way analysis of variance and posthoc Tukey-Kramer test and depiction of vessels and image noise , with Kruskal-Wallis test and pair-wise Mann-Whitney test with Bonferroni correction .
RESULTS	Mean iodine weight administered was significantly reduced in order of low - ( 16.4 g ) , moderate - ( 23.5 g ) , and high-iodine-load ( 33.7 g ) protocols ( P < .001 ) .
RESULTS	Mean CT numbers of abdominal aorta , renal artery , and renal cortex in first phase were significantly lower with high-iodine-load protocol ( 308 , 274 , and 132 HU , respectively ) than with moderate - ( 347 , 334 , and 156 HU , respectively ; P = .001 -.006 ) or low-iodine-load ( 362 , 316 , and 161 HU , respectively ; P = .001 -.003 ) protocol .
RESULTS	Mean CT number of renal vein in second phase was significantly lower with low-iodine-load protocol ( 223 HU ) than with moderate - ( 299 HU ; P < .001 ) or high-iodine-load ( 258 HU ; P = .020 ) .
RESULTS	Mean SNR of renal medulla in second phase was significantly lower ( P = .019 ) with moderate-iodine-load protocol ( mean SNR , 7.2 ) than with high-iodine-load protocol ( mean SNR , 10.0 ) .
RESULTS	No significant difference in image quality grades was found between high-iodine-load ( mean grade , 2.6-2 .9 ) , moderate-iodine-load ( mean grade , 2.6-3 .0 ) , and low-iodine-load ( mean grade , 2.6-2 .9 ) protocols ( P = .018 -.31 ) .
CONCLUSIONS	Combined application of low-iodine-load , bolus tracking with saline flushing , and low-tube-voltage scanning is feasible and resulted in substantial reduction of iodine dose for renal CT angiographic imaging without compromising image quality .

###24449819
BACKGROUND	Transendocardial stem cell injection ( TESI ) with mesenchymal stem cells improves remodeling in chronic ischemic cardiomyopathy , but the effect of the injection site remains unknown .
OBJECTIVE	To address whether TESI exerts its effects at the site of injection only or also in remote areas , we hypothesized that segmental myocardial scar and segmental ejection fraction improve to a greater extent in injected than in noninjected segments .
RESULTS	Biplane ventriculographic and endocardial tracings were recorded .
RESULTS	TESI was guided to 10 sites in infarct-border zones .
RESULTS	Sites were mapped according to the 17-myocardial segment model .
RESULTS	As a result , 510 segments were analyzed in 30 patients before and 13 months after TESI .
RESULTS	Segmental early enhancement defect ( a measure of scar size ) was reduced by TESI in both injected ( -43.7 4.4 % ; n = 95 ; P < 0.01 ) and noninjected segments ( -25.1 7.8 % ; n = 148 ; P < 0.001 ; between-group comparison P < 0.05 ) .
RESULTS	Conversely , segmental ejection fraction ( a measure of contractile performance ) improved in injected scar segments ( 19.9 3.3-26 .3 3.5 % ; P = 0.003 ) but not in noninjected scar segments ( 21.3 2.6-23 .5 3.2 % ; P = 0.20 ; between-group comparison P < 0.05 ) .
RESULTS	Furthermore , segmental ejection fraction in injected scar segments improved to a greater degree in patients with baseline segmental ejection fraction < 20 % ( 12.1 1.2-19 .9 2.7 % ; n = 18 ; P = 0.003 ) , versus < 20 % ( 31.7 3.4-35 .5 3.3 % ; n = 12 ; P = 0.33 , between-group comparison P < 0.0001 ) .
CONCLUSIONS	These findings illustrate a dichotomy in regional responses to TESI .
CONCLUSIONS	Although scar size reduction was evident in all scar segments , scar size reduction and ventricular functional responses preferentially occurred at the sites of TESI versus non-TESI sites .
CONCLUSIONS	Furthermore , improvement was greatest when segmental left ventricular dysfunction was severe .

###24613110
OBJECTIVE	To assess the effectiveness of recombinant human ( rh ) IL-11 to increase platelets count in patients suffering from Dengue fever ( DF ) .
METHODS	Randomized double blind placebo control study .
METHODS	Farooq Hospital , Lahore , from July to October 2011 .
METHODS	Forty hospitalized patients suffering from Dengue fever having platelets count 30000 per micro liter were randomly categorized into two groups , rhIL-11 ( test ) and distilled water ( placebo ) groups .
METHODS	The efficacy outcomes ( as indicated by step up in platelets count at 48 hours ) for the treatment group were compared with the outcomes for the placebo group .
RESULTS	The data revealed that the increase in platelet response with recombinant human interleukin 11 , 1.5 mg subcutaneously is significantly more brisk than the placebo group .
RESULTS	The platelets response in patients with severe thrombocytopenia was greater in the treatment group ( 50 % ) at 48 hours as compared to the placebo group ( 20 % ) ( p = 0.047 ) .
RESULTS	Response rate was slightly greater among males ( 6/10 , 60 % ) than females ( 8/16 , 50 % ) ; moreover , three-fourth ( 75 % ) female responders were in the placebo group , compared to half ( 50 % ) male responders in the treatment group .
CONCLUSIONS	Results of the study suggest that treatment of severe thrombocytopenia accompanying DF with recombinant human interleukin11 may be a useful therapeutic option .

###25336939
BACKGROUND	People with chronic obstructive pulmonary disease lead sedentary lives and could benefit from increasing their physical activity .
BACKGROUND	The purpose of this study was to determine if an exercise-specific self-efficacy enhancing intervention could increase physical activity and functional performance when delivered in the context of 4 months of upper body resistance training with a 12-month follow-up .
METHODS	IN THIS RANDOMIZED CONTROLLED TRIAL , SUBJECTS WERE ASSIGNED TO : exercise-specific self-efficacy enhancing intervention with upper body resistance training ( SE-UBR ) , health education with upper body resistance training ( ED-UBR ) , or health education with gentle chair exercises ( ED-Chair ) .
METHODS	Physical activity was measured with an accelerometer and functional performance was measured with the Functional Performance Inventory .
METHODS	Forty-nine people with moderate to severe chronic obstructive pulmonary disease completed 4 months of training and provided valid accelerometry data , and 34 also provided accelerometry data at 12 months of follow-up .
METHODS	The self-efficacy enhancing intervention emphasized meeting physical activity guidelines and increasing moderate-to-vigorous physical activity .
RESULTS	Differences were observed in light physical activity ( LPA ) after 4 months of training , time by group interaction effect ( P = 0.045 ) .
RESULTS	The SE-UBR group increased time spent in LPA by +20.6829.30 minutes/day and the other groups decreased time spent in LPA by -22.4347.88 minutes/day and -25.7351.76 minutes/day .
RESULTS	Changes in LPA were not sustained at 12-month follow-up .
RESULTS	There were no significant changes in moderate-to-vigorous physical activity , sedentary time , or functional performance .
RESULTS	Subjects spent most of their waking hours sedentary : 72 % 9 % for SE-UBR , 68 % 10 % for ED-UBR , and 74 % 9 % for ED-Chair .
CONCLUSIONS	The self-efficacy enhancing intervention produced a modest short-term increase in LPA .
CONCLUSIONS	Further work is needed to increase the magnitude and duration of effect , possibly by targeting LPA .

###25371053
BACKGROUND	Inhaled endotoxin induces airways ` neutrophilia , in human .
BACKGROUND	TNF-a being a key cytokine in the response to endotoxin , the effect of anti-TNF on the endotoxin-induced neutrophilic response was evaluated among healthy volunteers .
METHODS	Among a population of 30 healthy subjects , an induced-sputum was collected 2 weeks before , and 24 hours after an inhalation of 20 mcg endotoxin ( E. coli 026 : B6 ) .
METHODS	Then , the subjects were randomized into 3 parallel groups treated with control , oral methylprednisolone 20 mg/day during 7 days or anti-TNF ( adalimumab , Humira , Abbott ) 40 mg s.c. .
METHODS	One week later , an induced-sputum was sampled , 24 hours after an inhalation of endotoxin .
RESULTS	After endotoxin inhalation , the number of total cells , neutrophils and macrophages was significantly increased ( p < 0.001 ) .
RESULTS	Compared to the response to endotoxin among the control group , anti-TNF inhibited the endotoxin-induced neutrophil influx , both in relative ( 51.3 ( 6.4 ) % versus 26.2 ( 5.3 ) % , p < 0.002 ) and in absolute values ( 1321 ( 443-3935 ) cells/mcL versus 247 ( 68-906 ) cells/mcL , p < 0.02 ) .
RESULTS	The endotoxin-induced neutrophilic response was not significantly modified among the control group and oral corticosteroid group .
CONCLUSIONS	While oral corticosteroid had no effect , anti-TNF inhibited the neutrophil influx in sputum , induced by inhalation of endotoxin , in human subject .
CONCLUSIONS	The endotoxin model could be an early predictor of clinical efficacy of novel therapeutics .
BACKGROUND	ClinicalTrials.gov NCT02252809 ( EudraCT2008-005526-37 ) .

###26028346
OBJECTIVE	A previously published study demonstrated a pharmacogenetic association between the minor alleles of 2 VEGFR2 single nucleotide polymorphisms ( SNPs ) and greater improvement in visual acuity ( VA ) to treatment with ranibizumab , an anti-vascular endothelial growth factor ( VEGF ) drug , in patients with neovascular age-related macular degeneration ( AMD ) .
OBJECTIVE	We evaluated whether this association was replicated among patients who participated in the Comparison of AMD Treatments Trials ( CATT ) or the Alternative Treatments to Inhibit VEGF in Patients with Age-Related Choroidal Neovascularisation ( IVAN ) trial .
METHODS	Cohort studies within randomized clinical trials .
METHODS	Eight hundred thirty-five patients participating in CATT and 512 patients participating in IVAN .
METHODS	Each patient was genotyped for the SNPs rs4576072 and rs6828477 in the VEGFR2 gene .
METHODS	Mean change in VA from baseline to 1 year after initiation of treatment with ranibizumab or bevacizumab .
METHODS	Differences in VA response between the patient group homozygous for the minor allele of each SNP and the other genotype groups were evaluated with analysis of variance .
METHODS	Differences in VA response by the number of minor alleles present for either SNP or both combined were evaluated with tests of linear trend .
METHODS	Analyses were conducted separately for CATT and IVAN participants and with both the studies combined .
RESULTS	No statistically significant difference in mean change in VA was identified between genotypes of either SNP ( P 0.05 ) .
RESULTS	Furthermore , a stepwise analysis failed to show a significant interaction for either SNP based on the number of minor alleles present .
RESULTS	The lack of association was similar in both the CATT and IVAN cohorts and whether the analysis combined patients treated with either ranibizumab or bevacizumab or when restricted to patients treated with ranibizumab only .
CONCLUSIONS	The CATT and IVAN data do not support a pharmacogenetic association between the 2VEGFR2 SNPs , rs4576072 and rs6828477 , and change in VA in response to anti-VEGF therapy in patients with neovascular AMD .

###24473502
OBJECTIVE	Amiodarone is used commonly for pharmacological cardioversion of atrial fibrillation ( AF ) , but it is limited by moderate efficacy and delayed action .
OBJECTIVE	Ranolazine and amiodarone are markedly synergistic in suppressing experimental AF in vitro , yet the clinical efficacy of ranolazine combined with amiodarone for AF conversion has only undergone minimal investigation .
OBJECTIVE	This prospective , single-blinded , randomized study compared the safety and efficacy of ranolazine added to amiodarone vs. amiodarone alone for conversion of recent-onset AF .
RESULTS	We enroled 121 patients ( 64 10 years , 45 % male ) with recent-onset ( < 48 h duration ) AF who were eligible for pharmacological cardioversion .
RESULTS	Patients received either 24 h amiodarone infusion ( loading dose 5 mg/kg followed by maintenance dose of 50 mg/h ; n = 60 ) , or amiodarone infusion at the same dosage plus a single oral dose of ranolazine 1500 mg ( n = 61 ) .
RESULTS	Patients in the amiodarone plus ranolazine group compared with the amiodarone-only group showed significantly higher conversion rates at 24 h ( 87 vs. 70 % , respectively ; P = 0.024 ) and at 12 h ( 52 vs. 32 % ; P = 0.021 ) , and shorter time to conversion ( 10.2 3.3 vs. 13.3 4.1 h ; P = 0.001 ) .
RESULTS	Subgroup analysis identified higher 24 h conversion in patients with left atrial ( LA ) diameter > 46 mm who received the combination treatment vs. amiodarone alone ( 81 vs. 54 % ; P = 0.02 ) , whereas the efficacy of the two interventions did not differ among patients with LA diameter 46 mm ( P = 0.77 ) .
RESULTS	There was modest QT prolongation in both the groups , no serious adverse reactions , and no pro-arrhythmic events .
CONCLUSIONS	Addition of ranolazine to amiodarone was safe and well tolerated in this study , and it demonstrated efficacy superior to amiodarone alone for conversion of recent-onset AF .
CONCLUSIONS	These findings may have clinical implications by offering a simple therapeutic manoeuvre to enhance amiodarone 's effectiveness for conversion of AF .

###24321804
BACKGROUND	QVA149 is an inhaled fixed-dose combination therapy under development for the treatment of chronic obstructive pulmonary disease ( COPD ) .
BACKGROUND	It combines indacaterol ( a longacting 2-agonist ) with glycopyrronium ( a longacting muscarinic antagonist ) as a dual bronchodilator .
BACKGROUND	We aimed to compare the efficacy , safety , and tolerability of QVA149 versus salmeterol-fluticasone ( SFC ) over 26 weeks in patients with moderate-to-severe COPD .
METHODS	In this multicentre double-blind , double-dummy , parallel-group study , 523 patients ( age 40 years or older , Global Initiative for Chronic Obstructive Lung Disease [ GOLD ] stages II-III , without exacerbations in the previous year ) were randomly assigned ( 1:1 ; via automated , interactive response technology and stratified for smoking status ) to once-daily QVA149 110/50 g or twice-daily SFC 50/500 g for 26 weeks .
METHODS	Efficacy was assessed in the full analysis set ( randomised patients who received at least one dose of study drug ) ; safety was assessed in all patients who received at least one dose of study drug .
METHODS	The primary endpoint was to demonstrate the superiority of QVA149 compared with SFC for the standardised area under the curve from 0 to 12 h post dose for forced expiratory volume in 1 second ( FEV1 AUC0-12h ) after 26 weeks of treatment .
METHODS	This trial was registered at ClinicalTrial.gov , NCT01315249 .
RESULTS	Between March 25 , 2011 , and March 12 , 2012 , 259 patients were randomly assigned to receive QVA149 and 264 to receive SFC. At week 26 , FEV1 AUC0-12h was significantly higher with QVA149 than with SFC ( treatment difference 0138 L ; 95 % CI 0100-0176 ; p < 00001 ) .
RESULTS	Overall incidence of adverse events ( including COPD exacerbations ) was 554 % ( 143 of 258 ) for the QVA149 group and 602 % ( 159 of 264 ) for the SFC group .
RESULTS	Incidence of serious adverse events was similar between treatment groups ( QVA149 , 13 of 258 [ 50 % ] ; SFC 14 of 264 [ 53 % ] ) ; COPD worsening was the most frequent serious adverse event ( one of 13 [ 04 % ] and three of 14 [ 11 % ] , respectively ) .
CONCLUSIONS	Once-daily QVA149 provides significant , sustained , and clinically meaningful improvements in lung function versus twice-daily SFC , with significant symptomatic benefit .
CONCLUSIONS	These results indicate the potential of dual bronchodilation as a treatment option for non-exacerbating symptomatic COPD patients .
BACKGROUND	Novartis Pharma AG .

###25110991
BACKGROUND	Though current hospital paging systems are neither efficient ( callbacks disrupt workflow ) , nor secure ( pagers are not Health Insurance Portability and Accountability Act [ HIPAA ] - compliant ) , they are routinely used to communicate patient information .
BACKGROUND	Smartphone-based text messaging is a potentially more convenient and efficient mobile alternative ; however , commercial cellular networks are also not secure .
OBJECTIVE	To determine if augmenting one-way pagers with Medigram , a secure , HIPAA-compliant group messaging ( HCGM ) application for smartphones , could improve hospital team communication .
METHODS	Eight-week prospective , cluster-randomized , controlled trial
METHODS	Stanford Hospital
METHODS	Three inpatient medicine teams used the HCGM application in addition to paging , while two inpatient medicine teams used paging only for intra-team communication .
METHODS	Baseline and post-study surveys were collected from 22 control and 41 HCGM team members .
RESULTS	When compared with paging , HCGM was rated significantly ( P < 0.05 ) more effective in : ( 1 ) allowing users to communicate thoughts clearly ( P = 0.010 ) and efficiently ( P = 0.009 ) and ( 2 ) integrating into workflow during rounds ( P = 0.018 ) and patient discharge ( P = 0.012 ) .
RESULTS	Overall satisfaction with HCGM was significantly higher ( P = 0.003 ) .
RESULTS	85 % of HCGM team respondents said they would recommend using an HCGM system on the wards .
CONCLUSIONS	Smartphone-based , HIPAA-compliant group messaging applications improve provider perception of in-hospital communication , while providing the information security that paging and commercial cellular networks do not .

###25960303
BACKGROUND	Evidence of a beneficial effect of exercise training on mediators of vascular disease is accumulating in chronic kidney disease ( CKD ) , but its effect on vascular function in vivo still has to be established .
BACKGROUND	The present study was designed to investigate whether a formal aerobic exercise training program improves peripheral endothelial function in patients with CKD stages 3 to 4 .
METHODS	Randomized controlled trial with a parallel-group design .
METHODS	48 patients with CKD stages 3 to 4 without established cardiovascular disease were randomly assigned to either an exercise training program or usual care .
METHODS	40 patients completed the study ( exercise training , 19 ; usual care , 21 ) .
METHODS	The 3-month home-based aerobic training program consisted of 4 daily cycling sessions of 10 minutes each at a target heart rate , calculated as 90 % of the heart rate achieved at the anaerobic threshold .
METHODS	Patients in the usual-care group were given standard therapy .
RESULTS	The primary outcome was peripheral endothelial function .
RESULTS	Secondary outcomes were aerobic capacity , arterial stiffness , numbers of endothelial ( EPCs ) and osteogenic progenitor cells ( OPCs ) , migratory function of circulatory angiogenic cells , and health-related quality of life .
METHODS	Endothelial function was assessed with flow-mediated dilation of the brachial artery , aerobic capacity by peak oxygen uptake ( VO ( 2peak ) ) , arterial stiffness by carotid-femoral pulse wave velocity , numbers of EPCs and OPCs by flow cytometry , circulatory angiogenic cell function by an in vitro migratory assay , and quality of life by the Kidney Disease Quality of Life-Short Form questionnaire .
RESULTS	Exercise training significantly improved VO ( 2peak ) and quality of life , but not in vivo vascular function ( flow-mediated dilation and carotid-femoral pulse wave velocity ) or cellular markers for vascular function ( EPC and OPC count and circulatory angiogenic cell migratory function ) .
CONCLUSIONS	Short duration and intermittent nature of the exercise intervention .
CONCLUSIONS	In patients with CKD stages 3 to 4 without overt cardiovascular disease , 3 months of aerobic exercise training improved VO ( 2peak ) and quality of life , without altering endothelial function or arterial stiffness .

###25108586
OBJECTIVE	To determine the most efficient route and timing of oxytocin administration for active management of the third stage of labor .
METHODS	A prospective randomized study was done at one center in Ankara , Turkey , between January and October 2010 .
METHODS	Women with a singleton pregnancy ( > 37 weeks ) who had a live vaginal birth were randomly allocated to four groups : iv-A ( intravenous oxytocin after delivery of the fetus ) , iv-B ( when anterior shoulder seen ) , im-A ( intramuscular oxytocin after delivery ) , and im-B ( when anterior shoulder seen ) .
METHODS	Postpartum blood loss within the first hour , hemoglobin , hematocrit , and duration of the third stage were compared .
RESULTS	A total of 600 eligible women were recruited ; 150 were assigned to each group .
RESULTS	Postpartum blood loss , prepartum and postpartum hemoglobin and hematocrit , and need for additional uterotonics were similar among groups ( P > 0.05 ) .
RESULTS	The duration of the third stage of labor and changes in hemoglobin and hematocrit were significantly reduced in group iv-B ( P < 0.05 ) .
RESULTS	Among women not exposed to oxytocin before delivery , postpartum blood loss was significantly lower in group iv-B ( P = 0.019 ) .
RESULTS	Labor augmentation was related to significantly increased postpartum blood loss in all groups except iv-A .
CONCLUSIONS	Although postpartum blood loss was similar in all groups , early intravenous administration seemed to have beneficial effects .
CONCLUSIONS	ClinicalTrials.gov : NCT01954186 .

###25042605
BACKGROUND	Stroke is the second-leading cause of death in low - and middle-income countries , but use of evidence-based therapies for stroke prevention in such countries , especially those in Africa , is extremely poor .
BACKGROUND	This study is designed to enhance the implementation and sustainability of secondary stroke-preventive services following hospital discharge .
OBJECTIVE	The primary study aim is to test whether a Chronic Care Model-based initiative entitled the Tailored Hospital-based Risk reduction to Impede Vascular Events after Stroke ( THRIVES ) significantly improves blood pressure control after stroke .
METHODS	This prospective triple-blind randomized controlled trial will include a cohort of 400 patients with a recent stroke discharged from four medical care facilities in Nigeria .
METHODS	The culturally sensitive , system-appropriate intervention comprises patient report cards , phone text messaging , an educational video , and coordination of posthospitalization care .
RESULTS	The primary outcome is improvement of blood pressure control .
RESULTS	Secondary endpoints include control of other stroke risk factors , medication adherence , functional status , and quality of life .
RESULTS	We will also perform a cost analysis of THRIVES from the viewpoint of government policy-makers .
CONCLUSIONS	We anticipate that a successful intervention will serve as a scalable model of effective postdischarge chronic blood pressure management for stroke in sub-Saharan Africa and possibly for other symptomatic cardiovascular disease entities in the region .

###24718270
BACKGROUND	Postoperative surgical site infections are one of the most frequent complications after open abdominal surgery , and triclosan-coated sutures were developed to reduce their occurrence .
BACKGROUND	The aim of the PROUD trial was to obtain reliable data for the effectiveness of triclosan-coated PDS Plus sutures for abdominal wall closure , compared with non-coated PDS II sutures , in the prevention of surgical site infections .
METHODS	This multicentre , randomised controlled group-sequential superiority trial was done in 24 German hospitals .
METHODS	Adult patients ( aged 18 years ) who underwent elective midline abdominal laparotomy for any reason were eligible for inclusion .
METHODS	Exclusion criteria were impaired mental state , language problems , and participation in another intervention trial that interfered with the intervention or outcome of this trial .
METHODS	A central web-based randomisation tool was used to randomly assign eligible participants by permuted block randomisation with a 1:1 allocation ratio and block size 4 before mass closure to either triclosan-coated sutures ( PDS Plus ) or uncoated sutures ( PDS II ) for abdominal fascia closure .
METHODS	The primary endpoint was the occurrence of superficial or deep surgical site infection according to the Centers for Disease Control and Prevention criteria within 30 days after the operation .
METHODS	Patients , surgeons , and the outcome assessors were masked to group assignment .
METHODS	Interim and final analyses were by modified intention to treat .
METHODS	This trial is registered with the German Clinical Trials Register , number DRKS00000390 .
RESULTS	Between April 7 , 2010 , and Oct 19 , 2012 , 1224 patients were randomly assigned to intervention groups ( 607 to PDS Plus , and 617 to PDS II ) , of whom 1185 ( 587 PDS Plus and 598 PDS II ) were analysed by intention to treat .
RESULTS	The study groups were well balanced in terms of patient and procedure characteristics .
RESULTS	The occurrence of surgical site infections did not differ between the PDS Plus group ( 87 [ 148 % ] of 587 ) and the PDS II group ( 96 [ 161 % ] of 598 ; OR 091 , 95 % CI 066-125 ; p = 064 ) .
RESULTS	Serious adverse events also did not differ between the groups-146 of 583 ( 250 % ) patients treated with PDS Plus had at least one serious adverse event , compared with 138 of 602 ( 229 % ) patients treated with PDS II ; p = 039 ) .
CONCLUSIONS	Triclosan-coated PDS Plus did not reduce the occurrence of surgical site infection after elective midline laparotomy .
CONCLUSIONS	Innovative , multifactorial strategies need to be developed and assessed in future trials to reduce surgical site infections .
BACKGROUND	Johnson & Johnson Medical Limited .

###25569408
OBJECTIVE	Tonsillectomy is the oldest and most frequently performed surgical procedure practiced by ear , nose , and throat physicians .
OBJECTIVE	In this study , our aim was to compare the analgesic effects of peritonsillar , rectal , as well as intravenous infiltration of ketamine and intravenous tramadol hydrochloride infiltration for postoperative pain relief and sedation after tonsillectomy in children .
METHODS	This randomized controlled study evaluated the effects of peritonsillar , intravenous , and rectal infiltration of ketamine in children undergoing adenotonsillectomy .
METHODS	One hundred twenty children who were categorized under American Society of Anesthesiologists classes I to II were randomized to 4 groups of 30 members each .
METHODS	Group 1 received intravenous ( IV ) ketamine ( 0.5 mg/kg ) , group 2 received rectal ketamine ( 0.5 mg/kg ) , group 3 received local peritonsillar ketamine ( 2 mg/kg ) , and the control group received IV tramadol hydrochloride infiltration ( 2 mg/kg ) .
METHODS	Children 's Hospital of Eastern Ontario Pain Scale scores and Wilson sedation scale were recorded at minutes 1 , 15 , 30 , 60 as well as hours 2 , 12 , and 24 postoperatively .
METHODS	The patients were interviewed on the day after the surgery to assess the postoperative pain and sedation .
RESULTS	All the routes of infiltration of ketamine were as effective as those of tramadol hydrochloride ( P > 0.05 ) .
RESULTS	A statistically significant difference was observed between IV infiltrations and all groups during the assessments at hours 6 and 24 .
RESULTS	The analgesic efficacy of IV ketamine was found especially higher at hours 6 and 24 ( P ( 6 ) = 0.045 , P ( 24 ) = 0.011 ) .
CONCLUSIONS	Perioperative , low-dose IV , rectal , or peritonsillar ketamine infiltration provides efficient pain relief without any adverse effects in children who would undergo adenotonsillectomy .

###25106761
OBJECTIVE	To compare the long-term clinical safety between two drug-eluting stents with different healing characteristics in the Patient Related Outcomes with Endeavour ( E-ZES ) vs. Cypher ( C-SES ) Stenting Trial ( PROTECT ) .
OBJECTIVE	At 3 years , there was no difference in the primary outcome of definite or probable stent thrombosis or in the other main secondary clinical outcomes consisting of the composite of death or myocardial infarction ( MI ) .
OBJECTIVE	Prespecified 4-year clinical follow-up was analysed .
RESULTS	Patient Related OuTcomes with Endeavour vs. Cypher Stenting Trial was a prospective , open-label randomized-controlled superiority trial powered to look at differences in long-term clinical safety , including stent thrombosis .
RESULTS	Dual antiplatelet therapy ( DAPT ) was prescribed for 3 months and up to 12 months based on current guidelines .
RESULTS	Patient Related OuTcomes with Endeavour vs. Cypher Stenting Trial enrolled 8791 patients undergoing elective or emergency PCI to E-ZES or C-SES .
RESULTS	There was no difference in DAPT usage between the two groups up to 4 years .
RESULTS	At 4-year follow-up , the primary outcome occurred in 1.6 % of E-ZES vs. 2.6 % of C-SES patients [ HR 0.63 ( 95 % CI 0.46-0 .85 ) , P = 0.003 ] .
RESULTS	The composite of all-cause death or large MI occurred in 6.7 % of E-ZES vs. 8.0 % of C-SES-treated patients [ HR 0.84 ( 95 % CI 0.71-0 .98 ) , P = 0.024 ] .
CONCLUSIONS	Drug-eluting coronary stents with different healing characteristics demonstrated different late safety profiles : after 4 years , compared with C-SES , E-ZES reduced the risk of stent thrombosis and the risk of the composite endpoints of death or MI .
CONCLUSIONS	Appropriately powered large-scale trials with long-term follow-up are critical to determine clinical safety and efficacy of permanently implanted coronary stents .
CONCLUSIONS	This trial is registered with ClinicalTrials.gov , number NCT00476957 .

###25648347
OBJECTIVE	This 2-arm crossover study compared the relative bioavailability of two dovitinib ( TKI258 ) formulations [ anhydrate clinical service form ( CSF ) capsule and monohydrate final market image ( FMI ) tablet ; Arm 1 ] and determined the effect of food on dovitinib exposure ( Arm 2 ) .
METHODS	Patients with advanced solid tumors , excluding breast cancer , were enrolled in 1 of the 2 arms of the study .
METHODS	Patients in Arm 1 were randomized to a single 500-mg dose of CSF capsule or FMI tablet followed by 7 days of rest and 500 mg of the other formulation .
METHODS	Patients in Arm 2 received 300 mg of FMI tablet daily and were randomized to follow 1 of 6 meal sequences , each with 3 prandial conditions : low fat ( LF ) , high fat ( HF ) , or no meal ( NM ) .
RESULTS	In Arm 1 ( n = 21 ) , 17 patients were evaluable .
RESULTS	FMI tablet compared with CSF capsule showed only slight reductions in the adjusted geometric means for area under the plasma concentration-time curve ( AUClast ; 3 % ) and maximum plasma concentration ( C max ; 1 % ) .
RESULTS	In Arm 2 ( n = 42 ) , 19 patients were evaluable .
RESULTS	HF meal versus NM showed a 9 % decrease in the adjusted geometric mean for AUClast and an 18 % decrease for C max .
RESULTS	Comparison of LF meal versus NM showed a 1 % decrease for AUClast and a 10 % decrease for C max .
RESULTS	Common adverse events suspected to be study drug related included vomiting , diarrhea , nausea , and fatigue .
CONCLUSIONS	Dovitinib FMI tablet had similar systemic exposure to the CSF capsule and was not affected by food .

###25725503
OBJECTIVE	In a published study on cervical cancer , 5-beam IMRT was inferior to single arc VMAT .
OBJECTIVE	Here we compare 9 , 12 , and 20 beam IMRT with single and dual arc VMAT .
METHODS	For each of 10 patients , automated plan generation with the in-house Erasmus-iCycle optimizer was used to assist an expert planner in generating the five plans with the clinical TPS .
RESULTS	For each patient , all plans were clinically acceptable with a high and similar PTV coverage .
RESULTS	OAR sparing increased when going from 9 to 12 to 20 IMRT beams , and from single to dual arc VMAT .
RESULTS	For all patients , 12 and 20 beam IMRT were superior to single and dual arc VMAT , with substantial variations in gain among the study patients .
RESULTS	As expected , delivery of VMAT plans was significantly faster than delivery of IMRT plans .
CONCLUSIONS	Often reported increased plan quality for VMAT compared to IMRT has not been observed for cervical cancer .
CONCLUSIONS	Twenty and 12 beam IMRT plans had a higher quality than single and dual arc VMAT .
CONCLUSIONS	For individual patients , the optimal delivery technique depends on a complex trade-off between plan quality and treatment time that may change with introduction of faster delivery systems .

###25142121
OBJECTIVE	Depression is common in heart failure ( HF ) and associated with adverse outcomes .
OBJECTIVE	Randomized comparisons of the effectiveness of HF care strategies by patients ' mood are scarce .
OBJECTIVE	We therefore investigated in a randomized trial a structured collaborative disease management programme ( HeartNetCare-HF ; HNC ) recording mortality , morbidity , and symptoms in patients enrolled after hospitalization for decompensated systolic HF according to their responses to the 9-item Patient Health Questionnaire ( PHQ-9 ) during an observation period of 180 days .
RESULTS	Subjects scoring < 12/12 were categorized as non-depressed/depressed , and those ignoring the questionnaire as PHQ-deniers .
RESULTS	Amongst 715 participants ( 6912years , 29 % female ) , 141 ( 20 % ) were depressed , 466 ( 65 % ) non-depressed , and 108 ( 15 % ) PHQ-deniers .
RESULTS	The composite endpoint of mortality and re-hospitalization was neutral overall and in all subgroups .
RESULTS	However , HNC reduced mortality risk in both depressed and non-depressed patients [ adjusted hazard ratios ( HRs ) 0.12 , 95 % confidence interval ( CI ) 0.03-0 .56 , P = 0.006 , and 0.49 , 95 % CI 0.25-0 .93 , P = 0.03 , respectively ] , but not in PHQ-deniers ( HR 1.74 , 95 % CI 0.77-3 .96 , P = 0.19 ; P = 0.006 for homogeneity of HRs ) .
RESULTS	Average frequencies of patient contacts in the HNC arm were 12.87.9 in non-depressed patients , 12.47.1 in depressed patients , and 5.57.2 in PHQ-deniers ( P < 0.001 ) .
CONCLUSIONS	Early after decompensation , HNC reduced mortality risk in non-depressed and even more in depressed subjects , but not in PHQ-deniers .
CONCLUSIONS	This suggests that differential acceptability and chance of success of care strategies such as HNC might be predicted by appropriate assessment of patients ' baseline characteristics including psychological disposition .
CONCLUSIONS	These post-hoc results should be reassessed by prospective evaluation of HNC in larger HF populations .

###24913343
OBJECTIVE	Generalized anxiety and panic disorders are a burden on the society because they are costly and have a significant adverse effect on quality of life .
OBJECTIVE	The aim of this study was to evaluate the cost-utility of a collaborative stepped care intervention for panic disorder and generalized anxiety disorder in primary care compared to care as usual from a societal perspective .
METHODS	The design of the study was a two armed cluster randomized controlled trial .
METHODS	In total 43 primary care practices in the Netherlands participated in the study .
METHODS	Eventually , 180 patients were included ( 114 collaborative stepped care , 66 care as usual ) .
METHODS	Baseline measures and follow-up measures ( 3 , 6 , 9 and 12 months ) were assessed using questionnaires .
METHODS	We applied the TiC-P , the SF-HQL and the EQ-5D respectively measuring health care utilization , production losses and health related quality of life .
RESULTS	The average annual direct medical costs in the collaborative stepped care group were 1854 Euro ( 95 % C.I. , 1726 to 1986 ) compared to 1503 ( 95 % C.I. , 1374 to 1664 ) in the care as usual group .
RESULTS	The average quality of life years ( QALYs ) gained was 0.05 higher in the collaborative stepped care group , leading to an incremental cost effectiveness ratio ( ICER ) of 6965 Euro per QALY .
RESULTS	Inclusion of the productivity costs , consequently reflecting the full societal costs , decreased the ratio even more .
CONCLUSIONS	The study showed that collaborative stepped care was a cost effective intervention for panic disorder and generalized anxiety disorder and was even dominant when a societal perspective was taken .
BACKGROUND	trialregister.nl , Netherlands Trial Register NTR107 .

###24291444
OBJECTIVE	Despite anecdotal reports of voice impairment in quadriplegia , the exact nature of these impairments is not well described in the literature .
OBJECTIVE	This article details objective and subjective voice assessments for people with quadriplegia at baseline and after a respiratory-targeted singing intervention .
METHODS	Randomized controlled trial .
METHODS	Twenty-four participants with quadriplegia were randomly assigned to a 12-week program of either a singing intervention or active music therapy control .
METHODS	Recordings of singing and speech were made at baseline , 6 weeks , 12weeks , and 6 months postintervention .
METHODS	These deidentified recordings were used to measure sound pressure levels and assess voice quality using the Multidimensional Voice Profile and the Perceptual Voice Profile .
RESULTS	Baseline voice quality data indicated deviation from normality in the areas of breathiness , strain , and roughness .
RESULTS	A greater percentage of intervention participants moved toward more normal voice quality in terms of jitter , shimmer , and noise-to-harmonic ratio ; however , the improvements failed to achieve statistical significance .
CONCLUSIONS	Subjective and objective assessments of voice quality indicate that quadriplegia may have a detrimental effect on voice quality ; in particular , causing a perception of roughness and breathiness in the voice .
CONCLUSIONS	The results of this study suggest that singing training may have a role in ameliorating these voice impairments .

###25432143
BACKGROUND	Medications to control intraocular pressure ( IOP ) are frequently preserved using benzalkonium chloride ( BAK ) , which can negatively affect the ocular surface .
BACKGROUND	Data are needed to assess efficacy and safety of prostaglandin drugs preserved with and without BAK .
BACKGROUND	The present study compared the efficacy and safety of BAK-free travoprost 0.004 % ( TRAV ) and BAK 0.02 % - preserved bimatoprost 0.01 % ( BIM ) during late-day time points in patients with open-angle glaucoma or ocular hypertension .
METHODS	This was a 12-week , phase 4 , randomized , investigator-masked , crossover study .
METHODS	84 patients with IOP 24 and < 36 mmHg were randomized 1:1 to receive once-daily TRAV or BIM for 6 weeks followed by an additional 6-week crossover period .
METHODS	IOP was measured at the end of each treatment period at 4 , 6 , and 8 pm .
METHODS	TRAV was considered noninferior to BIM if the upper limit of the 95 % CI of the between-group difference in mean IOP was 1.5 mmHg .
METHODS	Adverse events were assessed throughout the study .
RESULTS	One patient discontinued due to allergic conjunctivitis , and 2 patients with missing data were excluded ; 81 patients were included in the per-protocol population ( mean SD age , 58.3 11.4 years ; TRAV/BIM , n = 41 ; BIM/TRAV , n = 40 ) .
RESULTS	After 6 weeks , mean IOP with TRAV ( 17.4 2.7 mmHg ; change from baseline , -6.0 mmHg ) was similar to BIM ( 17.2 2.6 mmHg ; change from baseline , -6.3 mmHg ) ; the between-group difference was 0.22 mmHg ( 95 % CI , -0.22 to 0.67 ) .
RESULTS	Thus , noninferiority of TRAV versus BIM was demonstrated .
RESULTS	Mean IOP at each time point and mean and percentage IOP change from baseline were not significantly different between treatments .
RESULTS	All treatment-emergent adverse events were mild to moderate .
RESULTS	The incidences of mild ocular hyperemia with TRAV and BIM were 31 % and 39 % , respectively ; moderate hyperemia was observed in 2 % of patients receiving BIM .
CONCLUSIONS	Late-day IOP-lowering efficacy of BAK-free TRAV was noninferior to that of BAK 0.02 % - preserved BIM ; both reduced baseline IOP by 25 % .
CONCLUSIONS	Both treatments were well tolerated , although a higher incidence of moderate ocular hyperemia was observed with BIM .
BACKGROUND	ClinicalTrials.gov identifier , NCT01464424 ; registered November 1 , 2011 .

###24610183
OBJECTIVE	Most electronic health record ( EHR ) systems have the capability of generating a printed after-visit summary ( AVS ) , but there has been little research on optimal content .
OBJECTIVE	We conducted a qualitative study and a randomized trial to understand the effect of AVS content on patient recall and satisfaction .
METHODS	Adult primary care patients ( n = 272 ) with at least 1 chronic condition were randomly assigned to 4 AVS content conditions : minimum , intermediate , maximum , or standard AVS .
METHODS	Demographics and health literacy were measured at an index clinic visit .
METHODS	Recall and satisfaction were measured by telephone 2 days and 2 to 3 weeks after the clinic visit .
RESULTS	Average age was 52 years ; 75 % of patients were female , 61 % were Hispanic , and 21 % were African American , and 64 % had adequate health literacy .
RESULTS	Average medication recall accuracy was 53 % at 2 days and 52 % at 3 weeks , with no significant difference among groups at either time .
RESULTS	Satisfaction with AVS content was high and did not differ among groups .
RESULTS	Recall of specific content categories was low and unrelated to group assignment .
RESULTS	Health literacy was unrelated to recall and satisfaction .
CONCLUSIONS	Primary care patients like to receive an AVS , but the amount of information included does not affect content recall or satisfaction with the information .

###25070320
BACKGROUND	Adequate serum 25-hydroxyvitamin D concentrations , [ 25 ( OH ) D ] , are required for optimal bone health , and low levels are associated with chronic diseases .
OBJECTIVE	We investigated whether 41 candidate single nucleotide polymorphisms ( SNPs ) in vitamin D and calcium pathway genes ( GC , DHCR7 , CYP2R1 , CYP27B1 , CYP24A1 , VDR , and CASR ) are associated with [ 25 ( OH ) D ] or modify the increase in [ 25 ( OH ) D ] from vitamin D3 supplementation .
METHODS	Baseline and year 1 [ 25 ( OH ) D ] measurements from a randomized controlled trial conducted at 11 clinical centers in the United States .
METHODS	A total of 1787 healthy non-Hispanic white participants aged 45-75 years .
METHODS	Vitamin D3 ( 1000 IU/d ) , calcium carbonate ( 1200 mg/d elemental ) , both , or placebo .
METHODS	Genotype main effects and interactions with vitamin D3 treatment estimated using multiple linear regression .
RESULTS	The baseline serum [ 25 ( OH ) D ] was 25.4 8.7 ng/mL ( mean SD ) .
RESULTS	Associations with baseline levels were discovered for SNPs in CYP24A1 ( rs2209314 , rs2762939 ) and confirmed for SNPs in GC and CYP2R1 .
RESULTS	After 1 year , [ 25 ( OH ) D ] increased on average by 6.1 8.9 ng/mL on vitamin D3 treatment and decreased by 1.1 8.4 ng/mL on placebo .
RESULTS	The increase in [ 25 ( OH ) D ] due to vitamin D3 supplementation was modified by genotypes at rs10766197 near CYP2R1 , rs6013897 near CYP24A1 , and rs7968585 near VDR .
CONCLUSIONS	The increase in [ 25 ( OH ) D ] attributable to vitamin D3 supplementation may vary according to common genetic differences in vitamin D 25-hydroxylase ( CYP2R1 ) , 24-hydroxylase ( CYP24A1 ) , and the vitamin D receptor ( VDR ) genes .
CONCLUSIONS	These findings have implications for achieving optimal vitamin D status and potentially for vitamin D-related health outcomes .

###24439245
BACKGROUND	The purpose of this study was to evaluate postoperative pain levels after arthroscopic elbow surgery under general anesthesia and to determine whether an axillary nerve block provides additional pain management benefits compared with a portal site injection of local anesthetic .
METHODS	Thirty-six patients undergoing arthroscopic elbow surgery under general anesthesia were randomized to either a study group receiving axillary nerve block ( Ax group ) or a control group receiving portal site injections of local anesthetic ( Lo group ) .
METHODS	During the first 48 hours after surgery , pain visual analog scale ( VAS ) scores ( 0-100 ) , total amount of oral analgesics required , and patient satisfaction were assessed .
RESULTS	Among all 36 patients , mean pain VAS scores at rest were 37 , 18 , and 9 for the first 12-hour period and at 24 and 48 hours after surgery , respectively .
RESULTS	The mean pain VAS scores during physiotherapy were 47 and 33 at 24 and 48 hours postoperatively , respectively .
RESULTS	No intergroup differences were observed between the Ax and Lo groups at any time point after surgery ( P value range , .41 to .87 ) .
RESULTS	The mean number of loxoprofen tablets required during the 48-hour study period was 5.1 in the Ax group and 4.5 in the Lo group ( P = .90 ) .
RESULTS	The Ax and Lo groups had mean overall patient satisfaction scores of 91 and 91 , respectively ( P = .98 ) .
CONCLUSIONS	Postoperative pain levels after arthroscopic elbow surgery could be well managed with oral analgesics and local anesthetic .
CONCLUSIONS	An axillary nerve block was not found to provide any postoperative pain control benefits .

###25132778
OBJECTIVE	To evaluate the benefit of aerobic exercise on colonic transit time ( CTT ) for psychiatric inpatients in a closed ward .
METHODS	Sixty consecutive adult inpatients of the Somang Hospital Psychiatry Unit ( Eumsung-gun , South Korea ) , without CTT-related diseases or drug therapies , were recruited for study from March to June of 2012 .
METHODS	Upon enrollment , the patients were randomly assigned to partake in a 12-wk instructor-led group aerobic exercise program ( exercise group ; n = 30 ) or to maintain their ordinary daily activities ( control group ; n = 30 ) .
METHODS	The exercise program was structured as 10 min warm-up ( stretching ) , 40 min exercise , and 10 min cool-down ( stretching ) for three days each week .
METHODS	The exercise sessions consisted of walking only in week one and aerobics from weeks two to 12 , with increasing intensity ( 50 % heart rate reserve ( HRR ) for weeks one to four , 60 % HRR for weeks five to eight , and 70 % HRR for weeks nine to 12 ) .
METHODS	CTT was measured before ( baseline ) and after ( week 12 ) the exercise program , in duplicate ( on days four and seven ) , using abdominal radiography and the multiple radio-opaque marker technique .
METHODS	Changes in the exercising patients ' CTT and weight - , cardiovascular - and fitness-related parameters were statistically assessed .
RESULTS	The study dropout rate was 30.0 % , with 23 patients in the exercise group and 19 patients in the control group completing the study .
RESULTS	At week 12 , the exercise group showed decreases in body weight ( mean SE ) baseline : 69.4 2.8 vs study-end : 67.6 2.7 ; P < 0.635 ) and body mass index ( BMI ) ( 25.2 1.1 vs 24.9 0.8 ; P < 0.810 ) , but the extent of change was not significantly different from that experienced by the control group ( body weight : 68.8 4.0 vs 68.8 3.9 ; BMI : 24.3 1.1 vs 24.4 1.2 ) .
RESULTS	However , the exercise group showed significant improvements in leg muscle strength ( baseline : 41.7 4.3 vs study-end : 64.1 5.0 ; P < 0.001 ) , cardio-respiratory endurance ( 120.5 4.5 vs 105.4 2.8 ; P < 0.004 ) , and leg muscle elasticity and power output ( 21.5 2.6 vs 30.6 2.8 ; P < 0.001 ) .
RESULTS	The exercise group showed an exercise-induced reduction in total CTT ( baseline : 54.2 8.0 vs 30.3 6.1 ) , which was significantly different from that experienced by the control group over the 12-wk period ( 48.6 9.3 vs 48.3 12.3 ; P = 0.027 ) ; however , the exercise-induced decreases in CTT involving the three colonic segments examined ( right , left and recto-sigmoid ) showed no significant differences from the control group .
CONCLUSIONS	A 12-wk aerobic exercise program can benefit psychiatric inpatients by increasing intestinal motility , possibly decreasing risk of metabolic - and cardiovascular-related disease .

###25765720
OBJECTIVE	Reported rates of hypoglycemia in patients with type 2 diabetes mellitus are lower with glimepiride as compared to glyburide .
OBJECTIVE	The aim of this study was to determine whether physiologic differences in counterregulatory neuroendocrine and metabolic mechanisms during hypoglycemia provide a basis for the observed clinical differences between glimepiride and glyburide .
METHODS	Non-diabetic volunteers ( age 382years , BMI 261kg/m ( 2 ) ) were studied in a single-blind fashion during separate 2day randomized protocols consisting of 2h hyperinsulinemic ( 9pmol/kg/min ) euglycemic ( 4.90.1 mmol ) and hypoglycemic ( 2.90.1 mmol/L ) clamps .
METHODS	Individuals received biologically equivalent doses of glimepiride ( 4mg ) or glyburide ( 10mg ) 1h prior to each glucose clamp ( n = 11 ) as well as a control group of placebo studies .
METHODS	Glucose kinetics were calculated using D-Glucose-6-6d2 .
RESULTS	Insulin and C-peptide levels were increased ( p < 0.05 ) during euglycemia in both sulfonylurea groups as compared to placebo .
RESULTS	However , despite equivalent hypoglycemia , insulin and C-peptide levels were higher ( p < 0.05 ) only after glyburide .
RESULTS	Glucagon responses and endogenous glucose production ( EGP ) were decreased ( p < 0.05 ) during hypoglycemia following glyburide administration as compared to glimepiride .
RESULTS	Glyburide reduced ( p < 0.05 ) norepinephrine responses during euglycemic clamps .
RESULTS	In addition combined epinephrine and norepinephrine responses during hypoglycemia were reduced ( p < 0.05 ) following glyburide as compared to placebo .
RESULTS	Leptin levels fell by a greater amount ( p < 0.05 ) during hypoglycemia with both sulfonylureas as compared to placebo .
CONCLUSIONS	In summary , glimepiride and glyburide can both similarly increase insulin and C-peptide levels during hyperinsulinemic euglycemia .
CONCLUSIONS	However , during moderate hyperinsulinemic hypoglycemia ( 2.9 mmol/L ) glyburide resulted in increased C-peptide and insulin , but blunted glucagon , sympathetic nervous system and EGP responses .
CONCLUSIONS	We conclude that glyburide can acutely reduce key neuroendocrine and metabolic counterregulatory defenses during hypoglycemia in healthy individuals .

###24836961
BACKGROUND	Tobramycin inhalation is an accepted treatment of chronic pseudomonal infection in cystic fibrosis ( CF ) patients .
BACKGROUND	Twice daily inhalation is efficacious , but time-consuming .
METHODS	In this randomized , open-label , multicentre , two-period , crossover study , 58 patients with CF and chronic Pseudomonas aeruginosa ( PA ) infection received two tobramycin nebuliser solutions : T100/eFlow or TNS/PARI LC PLUS .
METHODS	The primary objective was to demonstrate the equivalence of both treatments with respect to pharmacokinetics ( area under the concentration-time curve and maximum concentration in plasma ) .
METHODS	Secondary endpoints were tobramycin sputum pharmacokinetics , reduction in PA colony forming units , improvement of lung function , incidence of adverse drug reactions and reduction of inhalation times .
RESULTS	Tobramycin plasma AUC and Cmax were lower after administration of T100 than after TNS .
RESULTS	The study failed to demonstrate systemic bioequivalence of the two treatments .
RESULTS	After T100 administration , tobramycin sputum AUC and Cmax achieved higher values than after TNS .
RESULTS	Changes in efficacy parameters from baseline were similar .
RESULTS	Safety profiles were not different or unexpected .
RESULTS	Inhalation time per inhalation was shorter during treatment with T100 .
CONCLUSIONS	The lower systemic drug burden and the higher local drug deposition together with a comparable efficacy/safety profile and a shorter inhalation time render T100/eFlow an attractive treatment option for CF patients .
CONCLUSIONS	( www.controlled-trials.com/ISRCTN85410458 ) .

###24597840
OBJECTIVE	Luseogliflozin is a novel sodium glucose cotransporter 2 inhibitor for type 2 diabetes mellitus ( T2DM ) treatment .
OBJECTIVE	An exploratory Phase II study was conducted to assess the efficacy and safety of several doses of luseogliflozin in Japanese T2DM patients .
METHODS	Japanese T2DM patients aged 20-74 years with hemoglobin A1c ( HbA1c ) of 6.9-10 .5 % , fasting plasma glucose ( FPG ) 126mg/dL and on diet therapy were randomized in a double-blind manner to receive luseogliflozin ( 0.5 , 2.5 , or 5mg ) or placebo once daily for 12 weeks ( n = 61 , 61 , 61 , and 56 , respectively ) .
METHODS	The primary endpoint was the change in HbA1c from baseline to end of treatment .
METHODS	Other endpoints included FPG , 2h postprandial plasma glucose ( PPG ) in a meal tolerance test ( MTT ) , and body weight .
METHODS	Drug safety was also assessed .
BACKGROUND	Japan Pharmaceutical Information Center ( identifier : JapicCTI-090908 ) .
RESULTS	Changes in HbA1c from baseline to end of treatment were -0.36 , -0.62 , and -0.75 % in the 0.5 , 2.5 , and 5mg luseogliflozin groups , respectively , versus +0.06 % in the placebo group ( all P < 0.001 ) .
RESULTS	The reductions in FPG and 2h-PPG in the MTT were also significantly greater in the luseogliflozin groups ( all P < 0.01 ) without increases in insulin levels from baseline .
RESULTS	Luseogliflozin reduced body weight at all doses .
RESULTS	There were no significant differences in the incidences of adverse events among groups .
RESULTS	Most adverse events were mild in severity .
RESULTS	There were no serious adverse events .
CONCLUSIONS	Although this was a small-scale study with a short duration , all tested doses of luseogliflozin significantly improved glycemic control , reduced body weight , and were well tolerated in Japanese T2DM patients over the 12-week treatment period .

###25908462
OBJECTIVE	Short-term blood pressure variability ( BPV ) may predict outcome in acute stroke .
OBJECTIVE	We undertook a post hoc analysis of data from 2 randomized controlled trials to determine the effect of short-term BPV on 2-week outcome .
METHODS	Controlling Hypertension and Hypotension Immediately Post Stroke ( CHHIPS ) was a trial of BP-lowering , enrolling 179 acute stroke patients ( onset < 36 hours ) .
METHODS	Continue or Stop Post-Stroke Antihypertensives Collaborative Study ( COSSACS ) compared a strategy of continuation versus temporarily stopping prestroke antihypertensive therapy in 763 acute stroke patients ( onset < 48 hours ) .
METHODS	BPV at baseline ( defined as SD , coefficient of variation , variation independent of the mean , and average real variability ) was derived from standardized casual cuff BP measures ( 6 readings < 30 minutes ) .
METHODS	Adjusted logistic regression models were used to assess the relation between BPV and death and disability ( modified Rankin scale > 3 ) at 2 weeks .
RESULTS	Seven hundred six ( 92.5 % ) and 171 ( 95.5 % ) participants were included in the analysis for the COSSACS and CHHIPS data sets , respectively .
RESULTS	Adjusted logistic regression analyses revealed no statistically significant associations between any of the included BPV parameters with 2-week death or disability in either study data set : COSSACS , odds ratio SD systolic BP 0.98 ( 0.78-1 .23 ) ; CHHIPS , odds ratio SD systolic BP 0.97 ( 0.90-1 .11 ) .
CONCLUSIONS	When derived from casual cuff BP measures , short-term BPV is not a useful predictor of early ( 2 weeks ) outcome after acute stroke .
CONCLUSIONS	Differing methodology may account for the discordance with previous studies indicating long-term ( casual BPV ) and short-term ( beat-to-beat BPV ) prognostic value .
BACKGROUND	COSSACS was registered on the International Standard Randomised Controlled Trial Register ; URL : http://www.isrctn.com .
BACKGROUND	Unique identifier : ISRCTN89712435 .
BACKGROUND	CHHIPS was registered on the National Research Register ; URL : http://public.ukcrn.org.uk .
BACKGROUND	Unique identifier : N0484128008 .

###25258158
BACKGROUND	Stroke is a major cause of morbidity and mortality during open-heart surgery .
BACKGROUND	Up to 60 % of intraoperative cerebral events are emboli induced .
BACKGROUND	This randomized , controlled , multicenter trial is the first human study evaluating the safety and efficacy of a novel aortic cannula producing simultaneous forward flow and backward suction for extracting solid and gaseous emboli from the ascending aorta and aortic arch upon their intraoperative release .
METHODS	Sixty-six patients ( 25 females ; 6810 years ) undergoing elective aortic valve replacement surgery , with or without coronary artery bypass graft surgery , were randomized to the use of the CardioGard ( CardioGard Medical , Or-Yehuda , Israel ) Emboli Protection cannula ( `` treatment '' ) or a standard ( `` control '' ) aortic cannula .
METHODS	The primary endpoint was the volume of new brain lesions measured by diffusion-weighted magnetic resonance imaging ( DW-MRI ) , performed preoperatively and postoperatively .
METHODS	Device safety was investigated by comparisons of complications rate , namely neurologic events , stroke , renal insufficiency and death .
RESULTS	Of 66 patients ( 34 in the treatment group ) , 51 completed the presurgery and postsurgery MRI ( 27 in the treatment group ) .
RESULTS	The volume of new brain lesion for the treatment group was ( meanstandard error of the mean ) 44.0064.00 versus 126.5628.74 mm3 in the control group ( p = 0.004 ) .
RESULTS	Of the treatment group , 41 % demonstrated new postoperative lesions versus 66 % in the control group ( p = 0.03 ) .
RESULTS	The complication rate was comparable in both groups .
CONCLUSIONS	The CardioGard cannula is safe and efficient in use during open-heart surgery .
CONCLUSIONS	Efficacy was demonstrated by the removal of a substantial amount of emboli , a significant reduction in the volume of new brain lesions , and the percentage of patients experiencing new brain lesions .

###25194517
BACKGROUND	The skills and knowledge that residents have to master has increased , yet the amount of hours that the residents are allowed to work has been reduced .
BACKGROUND	There is a strong need to improve training techniques to compensate for these changes .
BACKGROUND	One approach is to use simulation-training methods to shorten the learning curve for surgeons in training .
OBJECTIVE	To analyze the effect of surgical training using three-dimensional ( 3D ) simulation on the placement of lateral mass screws in the cervical spine on either cadavers or sawbones .
METHODS	A blinded randomized control study .
METHODS	Fifteen orthopedic residents , postgraduate year ( PGY ) 1 to 6 , were asked to simulate Magerl lateral mass screw trajectories from C3-C7 on cadavers using a navigated drill guide , but with no feedback as to the actual trajectory within the bone ( Baseline 1 ) .
METHODS	This was repeated to determine baseline accuracy ( Baseline 2 ) .
METHODS	They were then randomized into three groups : Group 1 , control , did not receive any training , whereas Groups 2 and 3 received 3D navigational feedback as to the intended drill trajectory on sawbones and cadavers , respectively .
METHODS	All three groups then performed final simulated drilling ( final test ) .
METHODS	All 3D images were deidentified and reviewed by a blinded single fellowship-trained orthopedic spine surgeon .
METHODS	Each image/screw was measured for the starting site , caudad/cephalad angle , and medial/lateral angle to determine trajectory accuracy .
RESULTS	The aggregate mean difference from a perfect screw was compiled for each session for each group .
RESULTS	A negative difference shows improvement , whereas a positive difference shows regression .
RESULTS	The difference between final test and Baseline 1 in the control group was 2.4 , suggesting regression .
RESULTS	In contrast , the differences for groups sawbone and cadaver were -8.2 and -7.2 , respectively , suggesting improvement .
RESULTS	When comparing the difference in aggregate sum angle for the sawbones and cadaver groups with the control group , the difference was statistically significant ( p < .0001 ) .
CONCLUSIONS	Training with 3D navigation significantly improved the ability of orthopedic residents to properly drill simulated lateral mass screws .
CONCLUSIONS	As such , training with 3D navigation may be a useful adjunct in resident surgical education .

###24332524
OBJECTIVE	Anti-inflammatory therapeutic approaches are considered for the management of type 2 diabetes and for the prevention of its complications .
OBJECTIVE	There is limited evidence regarding the effects of prebiotics on inflammation , especially in patients with type 2 diabetes .
OBJECTIVE	This trial aims to examine the effects of oligofructose-enriched inulin on glycemic status , inflammation markers , and metabolic endotoxemia in female patients .
METHODS	Over a period of 8 wk , 52 women with body mass indices of > 25 kg/m ( 2 ) but < 35 kg/m ( 2 ) with type 2 diabetes were randomly assigned to either an intervention group , in which participants were given oligofructose-enriched inulin ( n = 27 , consuming 10 g/d of oligofructose-enriched inulin ) , or to a control group , in which participants were given maltodextrin ( n = 25 , consuming 10 g/d of maltodextrin ) .
METHODS	Fasting plasma glucose , glycosylated hemoglobin , high-sensitivity C-reactive protein , interleukin-6 , tumor necrosis factor - , interferon - , interleukin-10 , and plasma lipopolysaccharide were measured before and after the intervention .
METHODS	Data were analyzed with the use of SPSS software version 13 .
METHODS	Paired and unpaired Student t tests and analysis of covariance were used to compare quantitative variables .
RESULTS	Oligofructose-enriched inulin caused a significant decrease in the levels of fasting plasma glucose ( 19.2 mg/dL ; 9.50 % ) , glycosylated hemoglobin ( 1.0 % ; 8.40 % ) , interleukin-6 ( 1.3 pg/mL ; 8.15 % ) , tumor necrosis factor - ( 3.0 pg/mL ; 19.80 % ) and plasma lipopolysaccharide ( 6.0 EU/mL ; 21.95 % ) as compared with maltodextrin ( P < 0.05 ) .
RESULTS	Decreases in levels of interferon - ( 0.3 pg/mL ; 16.50 % ) and high-sensitivity C-reactive protein ( 3.9 ng/mL ; 31.70 % ) and an increase in the level of interleukin-10 ( 0.4 pg/mL , 11.50 % ) were not significant in the oligofructose-enriched inulin group as compared with the maltodextrin group .
CONCLUSIONS	In women with type 2 diabetes and suboptimal daily dietary fiber intake , oligofructose-enriched inulin may help to modulate some inflammatory markers .

###24373301
BACKGROUND	Interventions that make extensive use of theory tend to have larger effects on behaviour .
BACKGROUND	The Intervention Mapping ( IM ) framework incorporates theory into intervention design , implementation and evaluation , and was applied to the development of a community-based childhood obesity prevention intervention for a multi-ethnic population .
METHODS	IM was applied as follows : 1 ) Needs assessment of the community and culture ; consideration of evidence-base , policy and practice ; 2 ) Identification of desired outcomes and change objectives following identification of barriers to behaviour change mapped alongside psychological determinants ( e.g. knowledge , self-efficacy , intention ) ; 3 ) Selection of theory-based methods and practical applications to address barriers to behaviour change ( e.g. , strategies for responsive feeding ) ; 4 ) Design of the intervention by developing evidence-based interactive activities and resources ( e.g. , visual aids to show babies stomach size ) .
METHODS	The activities were integrated into an existing parenting programme ; 5 ) Adoption and implementation : parenting practitioners were trained by healthcare professionals to deliver the programme within Children Centres .
RESULTS	HAPPY ( Healthy and Active Parenting Programme for Early Years ) is aimed at overweight and obese pregnant women ( BMI > 25 ) ; consists of 12 2.5 hr .
RESULTS	sessions ( 6 ante-natal from 24weeks ; 6 postnatal up to 9months ) ; it addresses mother 's diet and physical activity , breast or bottle feeding , infant diet and parental feeding practices , and infant physical activity .
CONCLUSIONS	We have demonstrated that IM is a feasible and helpful method for providing an evidence based and theoretical structure to a complex health behaviour change intervention .
CONCLUSIONS	The next stage will be to assess the impact of the intervention on behaviour change and clinical factors associated with childhood obesity .
CONCLUSIONS	The HAPPY programme is currently being tested as part of a randomised controlled feasibility trial .

###24946965
BACKGROUND	Glycerol preserved acellular dermis ( Glyaderm ( ) ) consists of collagen and elastin fibers and is the first non-profit dermal substitute derived from glycerol-preserved , human allogeneic skin .
BACKGROUND	It is indicated for bi-layered skin reconstruction of full thickness wounds .
METHODS	A protocol for clinical application and optimal interval before autografting with split thickness skin graft ( STSG ) was developed in a pilot study .
METHODS	A phase III randomized , controlled , paired , intra-individual study compared full thickness defects engrafted with Glyaderm ( ) and STSG versus STSG alone .
METHODS	Outcome measures included percentage of Glyaderm ( ) take , STSG take , and scar quality assessment .
RESULTS	Pilot study ( 27 patients ) : Mean take rates equaled 91.55 % for Glyaderm ( ) and 96.67 % for STSG .
RESULTS	The optimal autografting interval was 6 days ( 1 day ) .
RESULTS	Randomized trial ( 28 patients ) : Mean Glyaderm ( ) take rate was 88.17 % .
RESULTS	STSG take rates were comparable for both research groups ( p = 0.588 ) .
RESULTS	One year after wound closure , Glyaderm ( ) + STSG was significantly more elastic ( p = 0.003 ) than STSG alone .
RESULTS	Blinded observers scored Glyaderm ( ) treated wounds better in terms of scar quality .
CONCLUSIONS	The efficacy of Glyaderm ( ) as a suitable dermal substitute for full thickness wounds is attested .
CONCLUSIONS	Currently a procedure for simultaneous application of Glyaderm ( ) and STSG is adopted , allowing for further widespread use of Glyaderm ( ) .

###25169040
BACKGROUND	Cardiac surgery has been shown to result in a significant decrease of the antioxidant selenium , which is associated with the development of multiorgan dysfunction and increased mortality .
BACKGROUND	Thus , a large-scale study is needed to investigate the effect of perioperative selenium supplementation on the occurrence of postoperative organ dysfunction .
METHODS	We plan a prospective , randomized double-blind , multicenter controlled trial , which will be conducted in North and South America and in Europe .
METHODS	In this trial we will include 1,400 high-risk patients , who are most likely to benefit from selenium supplementation .
METHODS	This includes patients scheduled for non-emergent combined and/or complex procedures , or with a predicted operative mortality of 5 % according to the EuroSCORE II .
METHODS	Eligible patients will be randomly assigned to either the treatment group ( bolus infusion of 2,000 g sodium selenite immediately prior to surgery , followed by an additional dosage of 2,000 g at ICU admission , and a further daily supplementation of 1,000 g up to 10 days or ICU discharge ) or to the control group ( placebo administration at the same time points ) .
METHODS	The primary endpoint of this study is a composite of ` persistent organ dysfunction ' ( POD ) and/or death within 30 days from surgery ( POD + death ) .
METHODS	POD is defined as any need for life-sustaining therapies ( mechanical ventilation , vasopressor therapy , mechanical circulatory support , continuous renal replacement therapy , or new intermittent hemodialysis ) at any time within 30 days from surgery .
CONCLUSIONS	The SUSTAIN-CSX study is a multicenter trial to investigate the effect of a perioperative high dosage sodium selenite supplementation in high-risk cardiac surgical patients .
BACKGROUND	This trial was registered at Clinicaltrials.gov ( identifier : NCT02002247 ) on 28 November 2013 .

###25535596
BACKGROUND	Heart failure ( HF ) disproportionately affects Native Hawaiians and Other Pacific Islanders ( NHOPIs ) .
BACKGROUND	This study examines risk factors associated with left ventricular ejection fraction ( LVEF ) among 151 hospitalized NHOPI HF patients enrolled at a single tertiary care hospital between June 2006 and April 2010 .
METHODS	Enrollment criteria : ( 1 ) NHOPI by self-identification .
METHODS	( 2 ) Age 21 yrs .
METHODS	( 3 ) Diagnosis of HF defined : ( a ) left ventricular ejection fraction ( LVEF ) 40 % or LVEF 60 % with abnormal diastolic function and ( b ) classic HF signs/symptoms .
METHODS	LVEF was measured by echocardiography within 6 weeks of hospitalization .
METHODS	Clinical measures , medical history , and questionnaires were assessed using standardized protocols .
METHODS	Linear regression modeling was used to examine the association of significant correlates of LVEF , which were then included en bloc into the final model .
METHODS	A P-value < .05 was considered statistically significant .
RESULTS	Of 151 participants , 69 % were men , mean age 54.3 13.5 years , blood pressure 112 20/69 15 mmHg , and body mass index ( BMI ) 36.9 9 kg/m ( 2 ) .
RESULTS	Twenty-five percent of participants were smokers , 45 % used alcohol and 23 % reported a history of methamphetamine use .
RESULTS	Clinically , 72 % had hypertension , 49 % were diabetic and 37 % had a prior myocardial infarction .
RESULTS	Nearly 60 % had moderate to severe LVEF ( < 35 % ) .
RESULTS	Higher LVEF was independently associated with female sex and greater BMI ( P < .04 ) while pacemaker/defibrillator and methamphetamine use was independently associated with lower LVEF ( P < .05 ) .
CONCLUSIONS	Methamphetamine use and BMI may be important modifiable risk factors associated with LVEF and may be important targets for improving HF morbidity and mortality .

###24983679
OBJECTIVE	The objective of the study was to evaluate the impact of doula support on first-trimester abortion care .
METHODS	Women were randomized to receive doula support or routine care during first-trimester surgical abortion .
METHODS	We examined the effect of doula support on pain during abortion using a 100 mm visual analog scale .
METHODS	The study had the statistical power to detect a 20 % difference in mean pain scores .
METHODS	Secondary measures included satisfaction , procedure duration , and patient recommendations regarding doula support .
RESULTS	Two hundred fourteen women completed the study : 106 received doula support , and 108 received routine care .
RESULTS	The groups did not differ regarding demographics , gestational age , or medical history .
RESULTS	Pain scores in the doula and control groups did not differ at speculum insertion ( 38.6 [ 26.3 mm ] vs 43.6 mm [ 25.9 mm ] , P = .18 ) or procedure completion ( 68.2 [ 28.0 mm ] vs 70.6 mm [ 23.5 mm ] , P = .52 ) .
RESULTS	Procedure duration ( 3.39 [ 2.83 min ] vs 3.18 min [ 2.36 min ] , P = .55 ) and patient satisfaction ( 75.2 [ 28.6 mm ] vs 74.6 mm [ 27.4 mm ] , P = .89 ) did not differ between the doula and control groups .
RESULTS	Among women who received doula support , 96.2 % recommended routine doula support for abortion and 60.4 % indicated interest in training as doulas .
RESULTS	Among women who did not receive doula support , 71.6 % of women would have wanted it .
RESULTS	Additional clinical staff was needed to provide support for 2.9 % of women in the doula group and 14.7 % of controls ( P < .01 ) .
CONCLUSIONS	Although doula support did not have a measurable effect on pain or satisfaction , women overwhelmingly recommended it for routine care .
CONCLUSIONS	Women receiving doula support were less likely to require additional clinic support resources .
CONCLUSIONS	Doula support therefore may address patient psychosocial needs .

###25342205
OBJECTIVE	The incidence of propofol injection pain during induction of general anesthesia varies from 28 % to 90 % .
OBJECTIVE	This prospective , randomized , double-blind , placebo-controlled study evaluated the effect of dexmedetomidine ( DEX ) for reducing the incidence and severity of propofol injection pain .
METHODS	Patients undergoing elective surgical procedures were randomly allocated into seven groups of 30 patients each .
METHODS	Experimental treatments were intravenously administered over 10 min ( total volume 10 mL ) prior to intravenous propofol injection , as follows : group I , the control group , was given isotonic saline .
METHODS	Patients in groups II , III , and IV received DEX 0.25 g/kg , 0.5 g/kg , or 1.0 g/kg , respectively , mixed with isotonic saline immediately before propofol injection .
METHODS	Patients in groups V , VI , and VII received DEX as above , but 5 minutes before propofol injection .
METHODS	Propofol consisted of 1 % long-chain triglyceride propofol ( 2.5 mg/kg ) injected at 1 mL/s .
RESULTS	Median propofol injection pain score was 0.00 ( IQR 0.00-3 .00 ) in patients who received 1.0 g/kg DEX 5 min before the propofol injection ( group VII ) , and only 1 patient ( of 30 ) in this group received a pain score > 2 .
RESULTS	The median pain score and number of patients with pain scores > 2 in group VII were both significantly less than in the control ( group I ; p = 0.000 , both ) .
RESULTS	There were no differences in either mean arterial pressure or heart rate at any time point after DEX injection among the groups .
CONCLUSIONS	Pretreatment with intravenous DEX 1 g/kg 5 min prior to injection of long-chain triglyceride propofol is effective and safe in reducing the incidence and severity of pain due to propofol injection .

###25672163
BACKGROUND	Hyperkalemia is one of the most dreadful complications of chronic kidney disease ( CKD ) .
BACKGROUND	Medical management includes use of cation exchange resins to reduce the amount of excessive potassium from the body .
BACKGROUND	Sodium polystyrene sulphonate ( SPS ) and calcium polystyrene sulphonate ( CPS ) are currently used for hyperklemia of CKD all over the world .
BACKGROUND	The objective was to compare the efficacy and safety of two different cation exchange resins ( CPS and SPS ) in patients of CKD with hyperkalemia .
METHODS	This randomized control trial was done at the Kidney Centre , Post Graduate Training Institute ( PGTi ) , Karachi , Pakistan between 15 January 2010 till 31st December 2010 to compare the efficacy and safety of , CPS and SPS in 97 CKD patients with hyperkalemia .
METHODS	The subjects were divided in two groups .
METHODS	Group-A received CPS while group-B received SPS .
METHODS	The data included symptoms , food recall , physical signs of volume overload and electrolytes .
METHODS	After receiving potassium binding resin for 3 days patients were evaluated for symptoms , weight gain , worsening of blood pressure and effect on electrolytes .
METHODS	Adverse events were recorded in an event reporting form .
RESULTS	Average potassium level pre resin was 5.8 _ 0.26 in group-A and 5.80.6 in group-B , which reduced to 4.80.5 in group-A and 4.30.53 in group-B suggesting the efficacy of both drugs for treatment of hyperkalemia in CKD patients .
RESULTS	Systolic blood pressure remains stable in both the groups while an increase in diastolic blood pressure was noticed in group-B patients ( p-value 0.004 ) .
RESULTS	No major adverse effect occurred in both the groups .
CONCLUSIONS	Both CPS and SPS can be used effectively for reducing hyperkalemia of CKD .
CONCLUSIONS	CPS showed fewer side effects as compared to SPS .

###24534128
BACKGROUND	The Combined Approach to Lysis Utilizing Eptifibatide and Recombinant Tissue Plasminogen Activator ( rt-PA ) in Acute Ischemic Stroke-Enhanced Regimen ( CLEAR-ER ) trial found that intravenous rt-PA plus eptifibatide ( combination arm ) in acute ischemic stroke ( AIS ) was safe and had a direction of effect that would justify a phase III trial .
BACKGROUND	CLEAR-ER had unanticipated imbalances between treatment groups .
BACKGROUND	We compared the rates of symptomatic intracranial hemorrhage ( sICH ) and good outcomes for combination therapy patients in the CLEAR-ER trial to a matched cohort of rt-PA patients from the National Institute of Neurological Disorders and Stroke ( NINDS ) trial .
METHODS	CLEAR-ER was a multicenter , double-blind , randomized study ; rt-PA-eligible AIS patients were randomized to .6 mg/kg rt-PA plus eptifibatide ( 135 mcg/kg bolus and .75 mcg/kg/min two-hour infusion ) versus standard rt-PA ( .9 mg/kg ) .
METHODS	For this analysis , we matched 1:1 CLEAR-ER combination therapy patients with rt-PA arm NINDS trial patients .
METHODS	Patients were matched by age , gender , race , baseline modified Rankin Scale score , baseline National Institutes of Health Stroke Scale ( NIHSS ) score , and stroke onset to rt-PA time .
RESULTS	Fifty-four matches were made .
RESULTS	One ( 1.8 % ) sICH occurred in each group ( odds ratio [ OR ] 1.00 , 95 % confidence interval [ CI ] .01 -78.50 ) .
RESULTS	At 90days , 51.8 % of the CLEAR-ER group had good outcomes versus 46.3 % in the NINDS rt-PA group ( OR 1.30 , 95 % CI .57 -2.96 ) .
RESULTS	For subjects with baseline NIHSS score > 12 ( CLEAR-ER median NIHSS score ) , 38.5 % of the CLEAR-ER group had good outcomes versus 23.1 % in the NINDS group ( OR 2.33 , 95 % CI .60 -9.02 ) .
CONCLUSIONS	The safety and direction of effect of eptifibatide plus rt-PA were confirmed .
CONCLUSIONS	A phase III trial is needed to determine the efficacy of eptifibatide plus rt-PA for improving long-term outcomes after AIS .

###24742399
OBJECTIVE	We explore gender differences in older adults ' appraisals of positive and negative aspects of their marriages , examine how these appraisals relate to global marital satisfaction , and identify distinctive marital profiles associated with global satisfaction in men and women .
METHODS	Data are from the Changing Lives of Older Couples Study ( n = 1,110 ) .
METHODS	We used a variant of principal components analysis to generate marital quality profiles , based on one 's endorsement of positive and negative marital characteristics .
METHODS	OLS regression was used to detect associations between marital profiles and global marital satisfaction .
RESULTS	Men offered more positive marital assessments than women , particularly on items reflecting positive treatment by one 's wife .
RESULTS	Three marital quality profiles emerged : Positive , Positive-Negative , and Negative .
RESULTS	Although marital satisfaction was best explained by positive appraisals in both genders , they were less important for men than for women .
RESULTS	The negative profile showed a tendency for a stronger prediction in men .
CONCLUSIONS	Prior studies show small differences in men 's and women 's global marital satisfaction .
CONCLUSIONS	Our work provides evidence that the presence and magnitude of such gender differences may vary based on the specific marital component considered .
CONCLUSIONS	We discuss ways that gender shapes marital interactions , expectations , and perceptions , and the implications of our results for the well-being of married older adults .

###24804913
BACKGROUND	Ward rounds represent an important task in clinical settings .
BACKGROUND	Despite their importance , students show substantial deficits in ward round competencies ( e.g. physical examination , drug prescription , documentation ) .
BACKGROUND	Previously reported teaching methods such as ward round training with standardized patients or educational wards , however , are time-consuming and expensive .
OBJECTIVE	To assess the effects of a structured on-ward supervision program for final-year students with specially trained supervising doctors focusing on ward round competencies .
METHODS	A total of 36 medical students were randomly assigned to an intervention group ( IG ) and a control group ( CG ) .
METHODS	During an eight-week-long training course , the intervention group ( IG ; n = 18 ) received structured ward round training while the control group ( CG ; n = 18 ) received on-ward training regarding how to take patient histories and perform physical examinations .
METHODS	Ward round competencies were assessed using simulated ward round scenarios with objective checklist ratings and standardized patient ratings .
RESULTS	The IG achieved significantly more predefined learning goals compared to the CG .
RESULTS	Standardized patient ratings did not differ significantly between groups .
CONCLUSIONS	RESULTS provide evidence that the presented program is a feasible and efficient tool for teaching ward round skills at the bedside .
CONCLUSIONS	Further research should focus on cost effectiveness compared to alternative models .

###24271567
BACKGROUND	Performance of transesophageal echocardiography ( TEE ) requires the psychomotor ability to obtain interpretable echocardiographic images .
BACKGROUND	The purpose of this study was to determine the effectiveness of a simulation-based curriculum in which a TEE simulator is used to teach the psychomotor skills to novice echocardiographers and to compare instructor-guided with self-directed online delivery of the curriculum .
METHODS	After institutional review board approval , subjects inexperienced in TEE completed an online review of TEE material prior to a baseline pre-test of TEE psychomotor skills using the simulator .
METHODS	Subjects were randomized to two groups .
METHODS	The first group received an instructor-guided lesson of TEE psychomotor skills with the simulator .
METHODS	The second group received a self-directed slide presentation of TEE psychomotor skills with the simulator .
METHODS	Both lessons delivered identical information .
METHODS	Following their respective training sessions , all subjects performed a post-test of their TEE psychomotor skills using the simulator .
METHODS	Two assessors rated the TEE performances using a validated scoring system for acquisition of images .
RESULTS	Pre-test TEE simulator scores were similar between the two instruction groups ( 9.0 vs 5.0 ; P = 0.28 ) .
RESULTS	The scores in both groups improved significantly following training , regardless of the method of instruction ( P < 0.0001 ) .
RESULTS	The improvement in scores ( post-test scores minus pre-test scores ) did not differ significantly between instruction groups ( 12.5 vs 14.5 ; P = 0.55 ) .
RESULTS	There was strong inter-rater reliability between assessors ( = 0.98 ; 95 % confidence interval [ CI ] : 0.97 to 0.99 ) .
CONCLUSIONS	High-fidelity TEE simulators are an effective training adjunct for the acquisition of basic TEE psychomotor skills .
CONCLUSIONS	There was no difference in improvement between the different modalities of instruction .
CONCLUSIONS	Further research will examine the need for a faculty resource for a curriculum in which a simulator is used as an adjunct .

###24468006
BACKGROUND	Complications due to hemodilution ( hematocrit value less than 22 % ) after cardiopulmonary bypass inevitably resulted with significantly greater intensive care requirements , long hospital stays , more operative costs , and increased mortality rates .
BACKGROUND	We tried to identify whether crystalloid cardioplegia is the strongest predictor of intraoperative hemodilution or not .
METHODS	One hundred patients were included into this randomized prospective study .
METHODS	Patients were divided into the two groups .
METHODS	Crystalloid cardioplegia were given to the odd-numbered patients ( Group 1 , n = 50 patients ) and blood cardioplegia were given to the even-numbered patients ( Group 2 , n = 50 patients ) .
METHODS	St. Thomas-II solution was used in Group-1 and Calafiore cold blood cardioplegia was in Group-2 .
RESULTS	Average intraoperative hematocrit value was 18.4 % 2.3 in crystalloid group 24.2 % 3.4 in blood cardioplegia group ( p < 0.001 ) .
RESULTS	The lowest hematocrit value was 15 % and 20 % in two groups respectively ( p < 0.001 ) .
RESULTS	In crystalloid group average intraoperative packed red blood cell ( RBC ) transfusion was 2.3 0.41 units , 0.7 0.6 units blood cardioplegia group ( p = 0.001 ) .
RESULTS	Average transfused RBC was 2.7 0.8 units in crystalloid group , 0.9 0.4 units blood cardioplegia group ( p < 0.001 ) .
RESULTS	Multivariate analyses confirmed age ( p = 0.005 , OR = 3.78 ) , female gender ( p = 0.003 , OR = 2.91 ) , longer cross-clamp time ( > 60 minutes ) ( p = 0.001 , OD = 0.97 ) , body surface area < 1.6 m2 ( p = 0.001 , OR = 6.01 ) and crystalloid cardioplegia ( p < 0.001 , OR = 0.19 ) as predictor of intraoperative hemodilution .
CONCLUSIONS	Crystalloid cardioplegia , compared to blood cardioplegia not only causes much more intra-operative hemodilution but also increases the blood transfusion requirement .
CONCLUSIONS	Hemodilution and increased transfusion increases the intensive care unit and hospital stay , in the early postoperative period .

###26041677
BACKGROUND	High phytate ( HP ) consumption is a concern in developing countries because of the high prevalence of iron deficiency in these countries .
OBJECTIVE	We investigated whether habitual consumption of an HP diet reduces the inhibitory effect of phytate on nonheme-iron absorption .
METHODS	Thirty-two nonanemic females , 18-35 y of age , with normal body mass index but with suboptimal iron stores ( serum ferritin , 30 g/L ) , were matched for serum ferritin concentration and randomly assigned to HP and low-phytate ( LP ) groups , in a parallel design study .
METHODS	Each subject consumed HP or LP foods with at least 2 of their daily meals for 8 wk , resulting in a change in phytate intake ( from 718 to 1190 mg/d in the HP group and 623 to 385 mg/d in the LP group ) .
METHODS	The serum iron response over 4 h after a test meal containing 350 mg of phytate was measured at baseline and postintervention .
METHODS	Ferritin , transferrin receptor , and hepcidin concentrations were measured at baseline and 8 wk .
RESULTS	Twenty-eight subjects completed the study ( n = 14 per group ) .
RESULTS	The serum iron response to the test meal increased in the HP group at postintervention , resulting in a 41 % increase in the area under the curve ( AUC ; P < 0.0001 ) .
RESULTS	However , no effect was observed in the LP group ( 21 % decrease in AUC ; P = 0.76 ) .
RESULTS	The postintervention serum iron response was lower ( P < 0.0001 ) in the LP group than in the HP group after controlling for the baseline serum iron response and hepcidin concentration , reflecting in a 64 % lower AUC .
CONCLUSIONS	We found that habitual consumption of an HP diet can reduce the negative effect of phytate on nonheme-iron absorption among young women with suboptimal iron stores .
CONCLUSIONS	Future studies are needed to explore possible mechanisms .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT02370940 .

###24485080
BACKGROUND	The realization of the prostatic biopsies is a painful act .
BACKGROUND	The objective of our work was to compare the analgesic efficiency of the injection of the lidocaine at the level of periprostatics laterals and apical areas compared with the use of gel of lidocaine intrarectal associated with the taking of oral tramadol .
METHODS	Between November 2007 and December 2009 , 60 patients admitted in the service of urology of the university hospital Mohammed VI of Marrakesh for prostatic biopsies were randomized in two groups .
METHODS	The group 1 ( 30 patients ) received two tablets from tramadol 50mg with 10 mL of gel of lidocaine 2 % intrarectal while 30 patients of the group 2 received 10 mL from lidocaine 2 % injected at the level of periprostatics laterals and apicales .
METHODS	The pain was estimated by a visual analog scale ( AVS ) at the introduction of the probe of echography ( AVS 1 ) , at the time of the biopsy ( AVS 2 ) and 20 minutes later ( AVS 3 ) .
RESULTS	There was no significant difference between both groups concerning AVS 1 means .
RESULTS	The average score of the pain was significantly lower in the group 2 for the AVS 2 and AVS 3 .
CONCLUSIONS	The periprostatics anesthesia assured a better control of the pain at the time of the prostatic biopsy and 20 minutes later , without increase of the complications .
CONCLUSIONS	We recommend it to decrease the pain and the discomfort related to this technique .

###25391168
BACKGROUND	Necrotizing enterocolitis ( NEC ) is the most serious gastrointestinal problem in very low birth weight preterm infants .
BACKGROUND	Multiple risk factors activate the inflammatory cascade leading to high expressions of pro-inflammatory mediators causing bowel injury in NEC .
BACKGROUND	The anti-inflammatory effect of probiotics is due to the inhibition and reduction of inflammatory signal in intestinal epithelium .
OBJECTIVE	To evaluate the efficacy of probiotics supplementation in the prevention of NEC among very low birth weight preterm infants .
METHODS	A prospective randomized controlled trial .
METHODS	All preterm infants with gestational age less than or equal to 34 weeks and birth weight less than or equal to 1,500 grams admitted in neonatal care unit , Queen Sirikit National Institute of Child Health during June 1st , 2012 and January 31th , 2013 were enrolled in this study .
METHODS	They were randomized into two groups , study and control group .
METHODS	Infants in the study group were fed Infloran ( Lactobacillus acidophilus 1 x 10 ( 9 ) and Bifidobacterium bifidum 1 x 10 ( 9 ) organisms ) dose 125 mg/kg/dose twice a day with breast milk or premature formula from the start of feeding until 6 weeks or discharge .
METHODS	Infants in the control group were fed with either breast milk or premature formula alone .
METHODS	The primary outcome was NEC stage 2 .
RESULTS	Sixty infants completed the study , 31 infants in the study group and 29 infants in the control group .
RESULTS	The baseline characteristic data of infants were similar except for more males in the present study group .
RESULTS	Incidence of NEC stage 2 were similar in both the groups , 3.2 vs. 3.4 % ( p = 0.74 ) .
RESULTS	There were no deaths during the study period .
RESULTS	Days to reach full feeding , 150 ml/kg/day , were no differences between the two groups , 12.03 5.49 days vs. 13.76 8.25 days ( p = 0.31 ) .
RESULTS	No adverse effects such as sepsis , flatulence or diarrhea were noted .
CONCLUSIONS	In this study , there was no difference in incidence of NEC stage 2 between the two groups .
CONCLUSIONS	No adverse effects of probiotics supplementation were observed .

###24447649
OBJECTIVE	Rasagiline is a selective , irreversible monoamine oxidase type B inhibitor , developed for the treatment of Parkinson 's disease .
OBJECTIVE	In compliance with current regulatory requirements , rasagiline underwent a thorough QT/QTc ( TQT ) study to assess its potential to prolong cardiac repolarization .
OBJECTIVE	The primary aim of this study was to evaluate the effects of clinical ( 1 mg/day ) and supratherapeutic ( 2 mg/day and 6 mg/day ) multiple oral doses of rasagiline on the baseline - and placebo-adjusted QTc interval ( delta delta QTc ( ddQTc ) ) .
OBJECTIVE	Other electrocardiogram parameters , pharmacokinetic assessments , safety and tolerability as well as vital signs were investigated .
METHODS	This was a five-arm , randomized , double-blind , placebo - and active-controlled , and parallel study in healthy subjects .
METHODS	Moxifloxacin ( 400 mg ) positive control was included to demonstrate assay sensitivity .
RESULTS	247 of 250 randomized subjects completed the study .
RESULTS	Time-matched analysis of ddQTc yielded two-sided 90 % confidence intervals for all rasagiline doses below the 10 ms regulatory threshold , showing no effect on cardiac repolarization .
RESULTS	Concentration-effect analysis demonstrated no relationships between rasagiline ( and its metabolite 1-aminoindan ) , plasma concentrations , and ddQTc .
RESULTS	The pharmacokinetic profile of rasagiline was consistent with previous studies .
RESULTS	Adverse events were mild to moderate in intensity and were similar across all treatment groups .
RESULTS	There were no clinically significant changes in heart rate and systolic blood pressure .
CONCLUSIONS	This TQT study demonstrated a favorable cardiac safety profile of rasagiline .

###24663388
BACKGROUND	Credible measures of disease incidence , trends and mortality can be obtained through surveillance using manual chart review , but this is both time-consuming and expensive .
BACKGROUND	ICD-10 discharge diagnoses are used as surrogate markers of infection , but knowledge on the validity of infections in general is sparse .
BACKGROUND	The aim of the study was to determine how well ICD-10 discharge diagnoses identify patients with community-acquired infections in a medical emergency department ( ED ) , overall and related to sites of infection and patient characteristics .
METHODS	We manually reviewed 5977 patients admitted to a medical ED in a one-year period ( September 2010-August 2011 ) , to establish if they were hospitalised with community-acquired infection .
METHODS	Using the manual review as gold standard , we calculated the sensitivity , specificity , predictive values , and likelihood ratios of discharge diagnoses indicating infection .
RESULTS	Two thousand five hundred eleven patients were identified with community-acquired infection according to chart review ( 42.0 % , 95 % confidence interval [ 95 % CI ] : 40.8-43 .3 % ) compared to 2550 patients identified by ICD-10 diagnoses ( 42.8 % , 95 % CI : 41.6-44 .1 % ) .
RESULTS	Sensitivity of the ICD-10 diagnoses was 79.9 % ( 95 % CI : 78.1-81 .3 % ) , specificity 83.9 % ( 95 % CI : 82.6-85 .1 % ) , positive likelihood ratio 4.95 ( 95 % CI : 4.58-5 .36 ) and negative likelihood ratio 0.24 ( 95 % CI : 0.22-0 .26 ) .
RESULTS	The two most common sites of infection , the lower respiratory tract and urinary tract , had positive likelihood ratios of 8.3 ( 95 % CI : 7.5-9 .2 ) and 11.3 ( 95 % CI : 10.2-12 .9 ) respectively .
RESULTS	We identified significant variation in diagnostic validity related to age , comorbidity and disease severity .
CONCLUSIONS	ICD-10 discharge diagnoses identify specific sites of infection with a high degree of validity , but only a moderate degree when identifying infections in general .

###24712563
BACKGROUND	The affect of the kidneys in elimination and degradation of intact incretin hormones and their truncated metabolites is unclear .
OBJECTIVE	To evaluate elimination and degradation of glucose-dependent insulinotropic polypeptide ( GIP ) and glucagon-like peptide-1 ( GLP-1 ) in patients with dialysis-dependent kidney failure .
METHODS	Twelve non-diabetic patients treated with chronic hemodialysis and 12 control subjects were examined in a double-blind , randomized , matched observational study at the Department of Nephrology , Rigshospitalet , University of Copenhagen , Denmark .
METHODS	Over 4 separate study days , synthetic human GIP or GLP-1 was infused with or without concurrent inhibition of dipeptidyl peptidase 4 using sitagliptin or placebo .
METHODS	Plasma concentrations of glucose , insulin , glucagon , and intact and total forms of GLP-1 or GIP were measured repeatedly .
METHODS	Plasma half-life ( T1/2 ) , metabolic clearance rate ( MCR ) , area under curve , and volume of distribution for intact and metabolite levels of GLP-1 and GIP were calculated .
RESULTS	Fasting concentrations of intact GLP-1 and GIP were increased in dialysis patients ( P < .001 ) whereas fasting levels of GLP-1 and GIP metabolites did not differ between groups ( P > .738 ) .
RESULTS	MCRs of intact GLP-1 and GIP , and the GLP-1 metabolite were reduced in dialysis patients on the placebo day ( P < .009 ) , and T1/2 of intact and metabolite forms of GLP-1 and GIP were comparable between groups ( P > .121 ) .
CONCLUSIONS	Unexpectedly , degradation and elimination of the intact and metabolite forms of GLP-1 and GIP seemed preserved , although reduced , in patients with dialysis-dependent kidney failure .

###25671655
OBJECTIVE	To explore the effects of combined intervention with education and progressive muscle relaxation ( PMR ) on quality of life ( QoL ) , functional disability , and positive symptoms of patients with acute schizophrenia .
METHODS	This randomized controlled study took place in an acute schizophrenia ward in Changsha , China .
METHODS	Sixty-four patients with acute schizophrenia were randomly assigned to four groups : control , education , PMR , and education plus PMR .
METHODS	QoL was assessed with the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form .
METHODS	Functional disability was assessed with the Sheehan Disability Scale .
METHODS	Severity of positive schizophrenia symptoms was assessed with the Scale for the Assessment of Positive Symptoms .
METHODS	All patients were evaluated at baseline ( within 72 hours before the interventions ) and at the end of weeks 5 ( when the interventions ended ) and week 15 ( a 10-week follow-up after the interventions ) .
RESULTS	The sociodemographic and clinical characteristics of all four study groups were similar at baseline .
RESULTS	Repeated-measures analysis of variance showed significant differences among the interventions in improving QoL , functional disability , and positive symptoms over time in the patients .
RESULTS	Education and PMR alone resulted in sustained improvement of QoL during the intervention period and a 10-week follow-up but had no significant effects on functional disability or positive schizophrenia symptoms .
RESULTS	In contrast , combined intervention with education and PMR showed better effects on improving QoL than did education or PMR alone throughout the 15-week study .
RESULTS	It also statistically significantly improved functional disability and positive schizophrenia symptoms during the intervention period and led to sustained improvement of functional disability during the 10-week follow-up .
CONCLUSIONS	A combined intervention with education and PMR is effective in improving QoL , functional disability , and positive symptoms in patients with acute schizophrenia .
CONCLUSIONS	The combined intervention model could be a new paradigm of adjunctive treatment for acute schizophrenia .

###25366707
OBJECTIVE	To evaluate the impact of radiological expertise on screen result decisions in a CT lung cancer screening trial .
METHODS	In the NELSON lung cancer screening trial , the baseline CT result was based on the largest lung nodule 's volume .
METHODS	The protocol allowed radiologists to manually adjust screen results in cases of high suspicion of benign or malignant nodule nature .
METHODS	Participants whose baseline CT result was based on a solid or part-solid nodule were included in this study .
METHODS	Adjustments by radiologists at baseline were evaluated .
METHODS	Histology was the reference for diagnosis or to confirm benignity and stability on subsequent CT examinations .
RESULTS	A total of 3,318 participants ( 2,796 male , median age 58.0 years ) were included .
RESULTS	In 195 participants ( 5.9 % ) the initial baseline screen result was adjusted by the radiologist .
RESULTS	Adjustment was downwards from positive or indeterminate to negative in two and 119 participants , respectively , and from positive to indeterminate in 65 participants .
RESULTS	None of these nodules turned out to be malignant .
RESULTS	In 9/195 participants ( 4.6 % ) the screen result was adjusted upwards from negative to indeterminate or indeterminate to positive ; two nodules were malignant .
CONCLUSIONS	In one in 20 cases of baseline lung cancer screening , nodules were reclassified by the radiologist , leading to a reduction of false-positive screen results .

###24622414
BACKGROUND	Type 1 diabetes results from autoimmune targeting of the pancreatic cells , likely mediated by effector memory T ( Tem ) cells .
BACKGROUND	CD2 , a T cell surface protein highly expressed on Tem cells , is targeted by the fusion protein alefacept , depleting Tem cells and central memory T ( Tcm ) cells .
BACKGROUND	We postulated that alefacept would arrest autoimmunity and preserve residual cells in patients newly diagnosed with type 1 diabetes .
METHODS	The T1DAL study is a phase 2 , double-blind , placebo-controlled trial in patients with type 1 diabetes , aged 12-35 years who , within 100 days of diagnosis , were enrolled at 14 US sites .
METHODS	Patients were randomly assigned ( 2:1 ) to receive alefacept ( two 12-week courses of 15 mg intramuscularly per week , separated by a 12-week pause ) or a placebo .
METHODS	Randomisation was stratified by site , and was computer-generated with permuted blocks of three patients per block .
METHODS	All participants and site personnel were masked to treatment assignment .
METHODS	The primary endpoint was the change from baseline in mean 2 h C-peptide area under the curve ( AUC ) at 12 months .
METHODS	Secondary endpoints at 12 months were the change from baseline in the 4 h C-peptide AUC , insulin use , major hypoglycaemic events , and HbA1c concentrations .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00965458 .
RESULTS	Of 73 patients assessed for eligibility , 33 were randomly assigned to receive alefacept and 16 to receive placebo .
RESULTS	The mean 2 h C-peptide AUC at 12 months increased by 0.015 nmol/L ( 95 % CI -0.080 to 0.110 ) in the alefacept group and decreased by 0.115 nmol/L ( -0.278 to 0.047 ) in the placebo group , and the difference between groups was not significant ( p = 0.065 ) .
RESULTS	However , key secondary endpoints were met : the mean 4 h C-peptide AUC was significantly higher ( mean increase of 0.015 nmol/L [ 95 % CI -0.076 to 0.106 ] vs decrease of -0.156 nmol/L [ -0.305 to -0.006 ] ; p = 0.019 ) , and daily insulin use ( 0.48 units per kg per day for placebo vs 0.36 units per kg per day for alefacept ; p = 0.02 ) and the rate of hypoglycaemic events ( mean of 10.9 events per person per year for alefacept vs 17.3 events for placebo ; p < 0.0001 ) was significantly lower at 12 months in the alefacept group than in the placebo group .
RESULTS	Mean HbA1c concentrations at week 52 were not different between treatment groups ( p = 0.75 ) .
RESULTS	So far , no serious adverse events were reported and all patients had at least one adverse event .
RESULTS	In the alefacept group , 29 ( 88 % ) participants had an adverse event related to study drug versus 15 ( 94 % ) participants in the placebo group .
RESULTS	In the alefacept group , 14 ( 42 % ) participants had grade 3 or 4 adverse events compared with nine ( 56 % ) participants in the placebo group ; no deaths occurred .
CONCLUSIONS	Although the primary outcome was not met , at 12 months , alefacept preserved the 4 h C-peptide AUC , lowered insulin use , and reduced hypoglycaemic events , suggesting efficacy .
CONCLUSIONS	Safety and tolerability were similar in the alefacept and placebo groups .
CONCLUSIONS	Alefacept could be useful to preserve - cell function in patients with new-onset type 1 diabetes .

###26372583
OBJECTIVE	Myopia has reached epidemic levels in parts of East and Southeast Asia .
OBJECTIVE	However , there is no effective intervention to prevent the development of myopia .
OBJECTIVE	To assess the efficacy of increasing time spent outdoors at school in preventing incident myopia .
METHODS	Cluster randomized trial of children in grade 1 from 12 primary schools in Guangzhou , China , conducted between October 2010 and October 2013 .
METHODS	For 6 intervention schools ( n = 952 students ) , 1 additional 40-minute class of outdoor activities was added to each school day , and parents were encouraged to engage their children in outdoor activities after school hours , especially during weekends and holidays .
METHODS	Children and parents in the 6 control schools ( n = 951 students ) continued their usual pattern of activity .
METHODS	The primary outcome measure was the 3-year cumulative incidence rate of myopia ( defined using the Refractive Error Study in Children spherical equivalent refractive error standard of -0.5 diopters [ D ] ) among the students without established myopia at baseline .
METHODS	Secondary outcome measures were changes in spherical equivalent refraction and axial length among all students , analyzed using mixed linear models and intention-to-treat principles .
METHODS	Data from the right eyes were used for the analysis .
RESULTS	There were 952 children in the intervention group and 951 in the control group with a mean ( SD ) age of 6.6 ( 0.34 ) years .
RESULTS	The cumulative incidence rate of myopia was 30.4 % in the intervention group ( 259 incident cases among 853 eligible participants ) and 39.5 % ( 287 incident cases among 726 eligible participants ) in the control group ( difference of -9.1 % [ 95 % CI , -14.1 % to -4.1 % ] ; P < .001 ) .
RESULTS	There was also a significant difference in the 3-year change in spherical equivalent refraction for the intervention group ( -1.42 D ) compared with the control group ( -1.59 D ) ( difference of 0.17 D [ 95 % CI , 0.01 to 0.33 D ] ; P = .04 ) .
RESULTS	Elongation of axial length was not significantly different between the intervention group ( 0.95 mm ) and the control group ( 0.98 mm ) ( difference of -0.03 mm [ 95 % CI , -0.07 to 0.003 mm ] ; P = .07 ) .
CONCLUSIONS	Among 6-year-old children in Guangzhou , China , the addition of 40 minutes of outdoor activity at school compared with usual activity resulted in a reduced incidence rate of myopia over the next 3 years .
CONCLUSIONS	Further studies are needed to assess long-term follow-up of these children and the generalizability of these findings .
BACKGROUND	clinicaltrials.gov Identifier : NCT00848900 .

###24884888
BACKGROUND	Suicide-related behaviour among young people is of significant concern , yet little is known regarding the effectiveness of interventions designed to reduce risk among this population .
BACKGROUND	Of those interventions that have been tested , cognitive-behavioural therapy appears to show some promise among young people with suicidal ideation .
BACKGROUND	Internet-based interventions are becoming increasingly popular and have shown some effect in preventing and treating depression and anxiety in young people .
BACKGROUND	However , to date there are no randomised controlled trials examining the impact of Internet-based Cognitive Behavioural Therapy among suicidal youth .
METHODS	This is a randomised controlled trial testing the effects of Internet-based cognitive-behavioural therapy among suicidal high school students who have sought help from the school wellbeing team .
METHODS	The intervention comprises 8 modules of Cognitive Behavioural Therapy delivered online .
METHODS	The study has a staggered , two-year recruitment phase and participants are assessed at baseline , post intervention and 12weeks later .
CONCLUSIONS	If effective the program has the ability to be readily adapted and delivered to a range of populations in a range of settings , at relatively little cost .
CONCLUSIONS	It can also be adapted for mobile applications .
BACKGROUND	ACTRN12613000864729 .
BACKGROUND	Date registered : 05/08/2013 .

###24400883
BACKGROUND	Online formative assessment continues to be an important area of research and methods which actively engage the learner and provide useful learning outcomes are of particular interest .
BACKGROUND	This study reports on the outcomes of a two year study of medical students using formative assessment tools .
METHODS	The study was conducted over two consecutive years using two different strategies for engaging students .
METHODS	The Year 1 strategy involved voluntary use of the formative assessment tool by 129 students .
METHODS	In Year 2 , a second cohort of 130 students was encouraged to complete the formative assessment by incorporating summative assessment elements into it .
METHODS	Outcomes from pre and post testing students around the formative assessment intervention were used as measures of learning .
METHODS	To compare improvement scores between the two years a two-way Analysis of Variance ( ANOVA ) model was fitted to the data .
RESULTS	The ANOVA model showed that there was a significant difference in improvement scores between students in the two years ( mean improvement percentage 19 % vs. 38.5 % , p < 0.0001 ) .
RESULTS	Students were more likely to complete formative assessment items if they had a summative component .
RESULTS	In Year 2 , the time spent using the formative assessment tool had no impact on student improvement , nor did the number of assessment items completed .
CONCLUSIONS	The online medium is a valuable learning resource , capable of providing timely formative feedback and stimulating student-centered learning .
CONCLUSIONS	However the production of quality content is a time-consuming task and careful consideration must be given to the strategies employed to ensure its efficacy .
CONCLUSIONS	Course designers should consider the potential positive impact summative components to formative assessment may have on student engagement and outcomes .

###25493600
OBJECTIVE	Estimate association between postpartum antiretroviral adherence and breast milk HIV-1 transmission .
METHODS	Prospective cohort study .
METHODS	Mother-infant pairs were randomized after delivery to immediately begin receiving 28 weeks of either triple maternal antiretrovirals ( zidovudine , lamivudine , and either nevirapine , nelfinavir , or lopinavir-ritonavir ) or daily infant nevirapine as part of the Breastfeeding , Antiretrovirals , and Nutrition ( BAN ) study .
METHODS	Associations between postpartum antiretroviral adherence and rate of breast milk HIV-1 transmission were estimated using Cox models .
METHODS	We measured adherence over four postpartum time intervals using pill count , suspension bottle weight , and maternal self-report .
METHODS	Adherence was categorized and lagged by one interval .
METHODS	Missing adherence measures were multiply imputed .
METHODS	Infant HIV-1 infection was determined by DNA PCR every 2-6 weeks .
METHODS	The primary endpoint was infant HIV-1 infection by 38 weeks of age among infants alive and uninfected at 5 weeks .
RESULTS	Analyses included 1479 mother-infant pairs and 45 transmission events .
RESULTS	Using pill count and bottle weight information , 22-40 % of mother-infant pairs at any given interval were less than 90 % adherent .
RESULTS	Having at least 90 % adherence was associated with a 52 % [ 95 % confidence interval ( CI ) 3-76 ] relative reduction in the rate of breast milk HIV-1 transmission , compared with having less than 90 % adherence when controlling for study arm , breastfeeding status , and maternal characteristics .
RESULTS	Complete case analysis rendered similar results ( n = 501 ; relative reduction 59 % , 95 % CI 6-82 ) .
CONCLUSIONS	Nonadherence to extended postpartum antiretroviral regimens in ` real world ' settings is likely to be higher than that seen in BAN .
CONCLUSIONS	Identifying mothers with difficulty adhering to antiretrovirals , and developing effective adherence interventions , will help maximize benefits of antiretroviral provision throughout breastfeeding .

###25446057
BACKGROUND	The Fontan procedure has improved survival in children with functionally univentricular hearts .
BACKGROUND	With time , however , complications such as reduced exercise capacity are seen more frequently .
BACKGROUND	Exercise intolerance is multifactorial , but pulmonary vascular resistance probably plays a crucial role .
BACKGROUND	Elevated pulmonary vascular resistance has been associated with raised levels of endothelin-1 , which are common both before and after Fontan operations .
BACKGROUND	Treatment with endothelin-1 receptor antagonists could theoretically improve cardiopulmonary hemodynamics and exercise capacity .
BACKGROUND	The aim of this study was therefore to examine the efficacy and safety of bosentan in Fontan patients .
RESULTS	Seventy-five adolescents and adults were randomized 1:1 to 14 weeks of treatment with bosentan or placebo .
RESULTS	Cardiopulmonary exercise test , functional class , blood samples , and quality-of-life questionnaires were evaluated at baseline and at the end of treatment .
RESULTS	Sixty-nine patients ( 92 % ) completed the study .
RESULTS	Peak oxygen consumption increased 2.0 mLkg ( -1 ) min ( -1 ) ( from 28.7 to 30.7 mLkg ( -1 ) min ( -1 ) ) in the bosentan group compared with 0.6 mLkg ( -1 ) min ( -1 ) ( from 28.4 to 29.0 mLkg ( -1 ) min ( -1 ) ) in the placebo group ( P = 0.02 ) .
RESULTS	Cardiopulmonary exercise test time increased by 0.48 minute ( from 6.79 to 7.27 minutes ) versus 0.08 minute ( from 6.94 to 7.02 minutes ; P = 0.04 ) .
RESULTS	Nine bosentan-treated patients improved 1 functional class , whereas none improved in the placebo group ( P = 0.0085 ) .
RESULTS	Side effects were mild and occurred equally in both groups .
RESULTS	No serious adverse effects were seen , and no patients had liver enzyme levels above the 3-fold upper limit .
CONCLUSIONS	Bosentan improves exercise capacity , exercise time , and functional class in Fontan patients without serious adverse events or hepatotoxicity .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01292551 .

###24605717
OBJECTIVE	To compare the glycaemic effect of 75 gram and 30 gram of natural honey in a honey tolerance test with that of 75 gram glucose in type 2 diabetics .
METHODS	The experimental study was conducted at the Jinnah Medical College Hospital , Karachi , and comprised 97 type 2 diabetic patients who came to the out-patient department between March and August 2011 .
METHODS	The patients were randomly divided into 75 gram honey group ( group 1 ) , 30 gram honey group ( group 2 ) , and 75 gram glucose group ( group 3 ) .
METHODS	Fasting blood samples were obtained as well as after 1 and 2 hour .
METHODS	SPSS 11 was used for statistical analysis .
RESULTS	Of the 97 participants , 62 ( 64 % ) were females and 35 ( 36 % ) males.Their ages ranged from 25-68 years .
RESULTS	Mean rise in blood glucose after two hours in group 2 was 30 mg/dl ; group 1 , 85mg/dl , and group 3 , 170 mg/dl .
RESULTS	The difference was statistically significant ( p < 0.005 ) .
RESULTS	The glucose response was significantly lower at 2 hours in group 2 ( p < 0.001 ) compared to group 1 or group 2 .
RESULTS	A significant difference was also seen in group 1 and 3 ( p < 0.0001 ) .
RESULTS	The plasma glucose level in response to honey peaked at 60 min and showed a rapid decline compared to that of glucose , indicating a lower glycaemic response of honey .
RESULTS	A small proportion of patients 3 ( 10.7 % ) even showed a glucose lowering effect after low dose of honey .
CONCLUSIONS	Low dose of honey can be a valuable sugar substitute for patients with diabetes .

###24636143
OBJECTIVE	Little is known about learning/adherence after different baby massage teaching strategies .
OBJECTIVE	We compared the learning/adherence after two strategies .
METHODS	Twenty mothers from the group manual-course ( GMC ) and 20 from the group manual-orientations ( GMO ) received a booklet .
METHODS	GMC participated in a course during the third trimester .
METHODS	GMO received verbal instructions during the postpartum hospital stay .
METHODS	Multiple-choice and practical tests assessed learning ( GMC : performing strokes on a doll ; GMO : on the baby ) .
METHODS	Adherence was measured 3 months after childbirth .
RESULTS	No differences were found between the groups in learning/adherence .
CONCLUSIONS	Both teaching strategies showed similar and positive results .

###24345073
BACKGROUND	Older adults can benefit from physical activity in numerous ways .
BACKGROUND	Physical activity is considered to be one of the few ways to influence the level of frailty .
BACKGROUND	Standardized exercise programs do not necessarily lead to more physical activity in daily life , however , and a more personalized approach seems appropriate .
BACKGROUND	The main objective of this study is to investigate whether a focused , problem-oriented coaching intervention ( ` Coach2Move ' ) delivered by a physiotherapist specializing in geriatrics is more effective for improving physical activity , mobility and health status in community-dwelling older adults than usual physiotherapy care .
BACKGROUND	In addition , cost-effectiveness will be determined .
METHODS	The design of this study is a single-blind randomized controlled trial in thirteen physiotherapy practices .
METHODS	Randomization will take place at the individual patient level .
METHODS	The study population consists of older adults , 70 years of age , with decreased physical functioning and mobility and/or a physically inactive lifestyle .
METHODS	The intervention group will receive geriatric physiotherapy according to the Coach2Move strategy .
METHODS	The control group will receive the usual physiotherapy care .
METHODS	Measurements will be performed by research assistants not aware of group assignment .
METHODS	The results will be evaluated on the amount of physical activity ( LASA Physical Activity Questionnaire ) , mobility ( modified ` get up and go ' test , walking speed and six-minute walking test ) , quality of life ( SF-36 ) , degree of frailty ( Evaluative Frailty Index for Physical Activity ) , fatigue ( NRS-fatigue ) , perceived effect ( Global Perceived Effect and Patient Specific Complaints questionnaire ) and health care costs .
CONCLUSIONS	Most studies on the effect of exercise or physical activity consist of standardized programs .
CONCLUSIONS	In this study , a personalized approach is evaluated within a group of frail older adults , many of whom suffer from multiple and complex diseases and problems .
CONCLUSIONS	A complicating factor in evaluating a new approach is that it may not be automatically adopted by clinicians .
CONCLUSIONS	Specific actions are undertaken to optimize implementation of the Coach2Move strategy during the trial .
CONCLUSIONS	Whether or not these will be sufficient is a matter we will consider subsequently , using quality indicators and process analysis .
BACKGROUND	The Netherlands National Trial Register : NTR3527 .

###25628196
OBJECTIVE	To evaluate and compare the effects of two chest physiotherapy interventions in patients hospitalized due to acute bronchiolitis .
METHODS	Prospective randomized study with a sample of 83 calls for 29 patients aged between 3 months and 1 year hospitalized for acute bronchiolitis .
METHODS	Patients were distributed randomly into two groups : Group 1 , submitted to postural drainage , tapping and tracheal aspiration ; and Group 2 , submitted to postural drainage , expiratory acceleration flow and tracheal aspiration .
METHODS	Assessments were made before and 10 and 60 minutes after the end of therapy .
METHODS	Patients also underwent drug treatment .
METHODS	The endpoint was to compare two physical therapy interventions as to clinical improvement in infants with acute bronchiolitis by means of oxygen saturation and the Respiratory Distress Assessment Instrument score .
METHODS	The parents/guardians was requested to answer a questionnaire about the treatment applied before the last evaluation in order to measure their satisfaction related to the interventions made .
RESULTS	The groups were similar regarding the use of antibiotics and bronchodilators .
RESULTS	A greater number of patients used corticosteroids in Group 2 .
RESULTS	A relevant improvement was observed on Respiratory Distress Assessment Instrument score with physical therapy , with reduction of the score 10 minutes after interventions , and the same score 60 minutes later , with no differences between techniques applied .
RESULTS	There was no significant variation of pulse oximetry after chest physiotherapy .
RESULTS	Most items assessed by the questionnaire had satisfactory answers .
CONCLUSIONS	No differences were observed between groups regarding the items assessed ( time required to discharge from study , pulse oximetry in room air and disease severity according to the Respiratory Distress Assessment Instrument score ) .
CONCLUSIONS	Parents answered positively about the effects of therapy in the majority of items in the questionnaire , both for the expiratory acceleration flow technique and for tapping .

###25095314
OBJECTIVE	The present study was conducted to compare and evaluate the relative efficacy of enamel microabrasion ( using 18 % HCl ) and bleaching with McInnes solution in the esthetic improvement of fluorosed teeth and to check postoperative sensitivity .
METHODS	30 children aged between 9-14yrs with a mild or moderate grade of fluorosis as classified according to Dean 's fluorosis index and who complained of objectionable esthetics were selected .
METHODS	Split mouth study design was selected in our study .
METHODS	Each subject had one of their maxillary central incisor randomly selected for Enamel microabrasion and the contra lateral maxillary central incisor for McInnes bleaching .
METHODS	Esthetic improvement was assessed by comparing the pre and postoperative digital photographs .
METHODS	During the evaluation session , the pre and postoperative photographs of 30 subjects were incorporated into a power point presentation and were projected side by side in a darkened room .
METHODS	Four calibrated and blinded examiners , including a layman rated the photographs under standardized viewing conditions .
METHODS	Esthetic improvement was assessed for both short and long term improvement .
METHODS	The postoperative sensitivity was recorded for both the procedures immediately after treatment and at one , three and six months interval .
RESULTS	The results proved that both immediate and long term ( 6 month ) esthetic improvement achieved by McInnes bleaching were superior to enamel microabrasion .
RESULTS	There is a reduction in aesthetics of teeth in both the procedures after six months , which was very minimal in McInnes procedure and significant in enamel micro abrasion .
RESULTS	Postoperative sensitivity in both techniques were negligible .
RESULTS	The sensitivity observed were transient and subsided within an one-month post operatively .
RESULTS	None of the subjects reported sensitivity at one , three and six months intervals .
CONCLUSIONS	McInnes bleaching is a better procedure compared to enamel microabrasion in improving the appearance of fluorosed teeth .
CONCLUSIONS	Both techniques are conservative and safe .

###25212745
BACKGROUND	The effectiveness of intermittent montelukast for wheeze in young children is unclear .
BACKGROUND	We aimed to assess whether intermittent montelukast is better than placebo for treatment of wheeze in this age group .
BACKGROUND	Because copy numbers of the Sp1-binding motif in the arachidonate 5-lipoxygenase ( ALOX5 ) gene promoter ( either 5/5 , 5/x , or x/x , where x does not equal 5 ) modifies response to montelukast in adults , we stratified by this genotype .
METHODS	We did this multicentre , parallel-group , randomised , placebo-controlled trial between Oct 1 , 2010 , and Dec 20 , 2013 , at 21 primary care sites and 41 secondary care sites in England and Scotland .
METHODS	Children aged 10 months to 5 years with two or more wheeze episodes were allocated to either a 5/5 or 5/x + x/x ALOX5 promoter genotype stratum , then randomly assigned ( 1:1 ) via a permuted block schedule ( size ten ) , to receive intermittent montelukast or placebo given by parents at each wheeze episode over a 12 month period .
METHODS	Clinical investigators and parents were masked to treatment group and genotype strata .
METHODS	The primary outcome was number of unscheduled medical attendances for wheezing episodes .
METHODS	Analysis was by intention to treat .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01142505 .
RESULTS	We randomly assigned 1358 children to receive montelukast ( n = 669 ) or placebo ( n = 677 ) .
RESULTS	Consent was withdrawn for 12 ( 1 % ) children .
RESULTS	Primary outcome data were available for 1308 ( 96 % ) children .
RESULTS	There was no difference in unscheduled medical attendances for wheezing episodes between children in the montelukast and placebo groups ( mean 20 [ SD 26 ] vs 23 [ 27 ] ; incidence rate ratio [ IRR ] 088 , 95 % CI : 077-101 ; p = 006 ) .
RESULTS	Compared with placebo , unscheduled medical attendances for wheezing episodes were reduced in children given montelukast in the 5/5 stratum ( 20 [ 27 ] vs 24 [ 30 ] ; IRR 080 , 95 % CI 068-095 ; p = 001 ) , but not in those in the 5/x + x/x stratum ( 20 [ 25 ] vs 20 [ 23 ] ; 103 , 083-129 ; p = 079 , pinteraction = 008 ) .
RESULTS	We recorded one serious adverse event , which was a skin reaction in a child allocated to placebo .
CONCLUSIONS	Our findings show no clear benefit of intermittent montelukast in young children with wheeze .
CONCLUSIONS	However , the 5/5 ALOX5 promoter genotype might identify a montelukast-responsive subgroup .
BACKGROUND	Medical Research Council ( UK ) and National Institute for Health Research .

###25148049
BACKGROUND	Chronic Obstructive Pulmonary Disease ( COPD ) is a progressive airway disease characterised by neutrophilic airway inflammation or bronchitis .
BACKGROUND	Neutrophilic bronchitis is associated with both bacterial colonisation and lung function decline and is common in exacerbations of COPD .
BACKGROUND	Despite current available therapies to control inflammation , neutrophilic bronchitis remains common .
BACKGROUND	This study tested the hypothesis that azithromycin treatment , as an add-on to standard medication , would significantly reduce airway neutrophil and neutrophils chemokine ( CXCL8 ) levels , as well as bacterial load .
BACKGROUND	We conducted a randomised , double-blind , placebo-controlled study in COPD participants with stable neutrophilic bronchitis .
METHODS	Eligible participants ( n = 30 ) were randomised to azithromycin 250 mg daily or placebo for 12 weeks in addition to their standard respiratory medications .
METHODS	Sputum was induced at screening , randomisation and monthly for a 12 week treatment period and processed for differential cell counts , CXCL8 and neutrophil elastase assessment .
METHODS	Quantitative bacteriology was assessed in sputum samples at randomisation and the end of treatment visit .
METHODS	Severe exacerbations where symptoms increased requiring unscheduled treatment were recorded during the 12 week treatment period and for 14 weeks following treatment .
METHODS	A sub-group of participants underwent chest computed tomography scans ( n = 15 ) .
RESULTS	Nine participants with neutrophilic bronchitis had a potentially pathogenic bacteria isolated and the median total bacterial load of all participants was 5.22107 cfu/mL .
RESULTS	Azithromycin treatment resulted in a non-significant reduction in sputum neutrophil proportion , CXCL8 levels and bacterial load .
RESULTS	The mean severe exacerbation rate was 0.33 per person per 26 weeks in the azithromycin group compared to 0.93 exacerbations per person in the placebo group ( incidence rate ratio ( 95 % CI ) : 0.37 ( 0.11,1.21 ) , p = 0.062 ) .
RESULTS	For participants who underwent chest CT scans , no alterations were observed .
CONCLUSIONS	In stable COPD with neutrophilic bronchitis , add-on azithromycin therapy showed a trend to reduced severe exacerbations sputum neutrophils , CXCL8 levels and bacterial load .
CONCLUSIONS	Future studies with a larger sample size are warranted .
BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12609000259246 .

###25537204
OBJECTIVE	The purpose of this study was to evaluate fixation location and oculomotor characteristics of 15 patients with Leber congenital amaurosis ( LCA ) caused by RPE65 mutations ( RPE65-LCA ) who underwent retinal gene therapy .
METHODS	Eye movements were quantified under infrared imaging of the retina while the subject fixated on a stationary target .
METHODS	In a subset of patients , letter recognition under retinal imaging was performed .
METHODS	Cortical responses to visual stimulation were measured using functional magnetic resonance imaging ( fMRI ) in two patients before and after therapy .
RESULTS	All patients were able to fixate on a 1 diameter visible target in the dark .
RESULTS	The preferred retinal locus of fixation was either at the anatomical fovea or at an extrafoveal locus .
RESULTS	There were a wide range of oculomotor abnormalities .
RESULTS	Natural history showed little change in oculomotor abnormalities if target illuminance was increased to maintain target visibility as the disease progressed .
RESULTS	Eleven of 15 study eyes treated with gene therapy showed no differences from baseline fixation locations or instability over an average of follow-up of 3.5 years .
RESULTS	Four of 15 eyes developed new pseudo-foveas in the treated retinal regions 9 to 12 months after therapy that persisted for up to 6 years ; patients used their pseudo-foveas for letter identification .
RESULTS	fMRI studies demonstrated that preservation of light sensitivity was restricted to the cortical projection zone of the pseudo-foveas .
CONCLUSIONS	The slow emergence of pseudo-foveas many months after the initial increases in light sensitivity points to a substantial plasticity of the adult visual system and a complex interaction between it and the progression of underlying retinal disease .
CONCLUSIONS	The visual significance of pseudo-foveas suggests careful consideration of treatment zones for future gene therapy trials .
CONCLUSIONS	( ClinicalTrials.gov number , NCT00481546 . )

###24429540
BACKGROUND	Data on the protein requirements of elderly adults are limited , because it is impractical to conduct repeated nitrogen balance protocols in these vulnerable humans .
OBJECTIVE	This study was designed to determine the dietary protein requirement of elderly women by using the recently developed minimally invasive indicator amino acid oxidation ( IAAO ) technique .
METHODS	Six white women aged 80-87 y [ mean SEM : 82 1 y and body mass index ( in kg/m ) 26 2 ] completed a 3-d protocol 7 times .
METHODS	Each woman consumed an adaptation diet for 2 d and on day 3 consumed a complete test diet with a crystalline amino acid mixture containing 1 of 7 protein intakes ( 0.1 , 0.3 , 0.6 , 0.9 , 1.2 , 1.5 , or 1.8 g kg d ) tested randomly .
METHODS	A group-based protein requirement was assessed by using a nonlinear mixed model of protein intake and L - [ 1-C ] phenylalanine oxidation .
METHODS	The breakpoint , at which there was no further decline in the rate of appearance of C in the breath , was used as an index of the mean protein requirement .
RESULTS	The mean protein requirement ( 95 % CI ) was 0.85 ( 0.60 , 1.09 ) g kg d.
RESULTS	This requirement is 29 % higher than the current Estimated Average Requirement ( EAR ) for adults of 0.66 g kg d based on the nitrogen balance technique , although the 95 % CI includes the current EAR .
RESULTS	The corresponding adequate protein allowance of 1.15 ( 0.77 , 1.54 ) g kg d is 44 % higher , although the 95 % CI includes the Recommended Dietary Allowance ( RDA ) of 0.80 g kg d.
CONCLUSIONS	Notwithstanding uncertainty about the validity of the use of the IAAO technique to assess protein requirements , the results of this study with octogenarian women suggest that the current EAR and RDA for elderly women may be underestimated .
CONCLUSIONS	The limitations of this short-term , noninvasive method underscore the need for new research that uses alternative experimental designs and measuring physiologic , morphologic , and health-related outcomes .

###25862516
BACKGROUND	Physician-rating websites combine public reporting with social networking and offer an attractive means by which users can provide feedback on their physician and obtain information about other patients ' satisfaction and experiences .
BACKGROUND	However , research on how users evaluate information on these portals is still scarce and only little knowledge is available about the potential influence of physician reviews on a patient 's choice .
OBJECTIVE	Starting from the perspective of prospective patients , this paper sets out to explore how certain characteristics of physician reviews affect the evaluation of the review and users ' attitudes toward the rated physician .
OBJECTIVE	We propose a model that relates review style and review number to constructs of review acceptance and check it with a Web-based experiment .
METHODS	We employed a randomized 2x2 between-subject , factorial experiment manipulating the style of a physician review ( factual vs emotional ) and the number of reviews for a certain physician ( low vs high ) to test our hypotheses .
METHODS	A total of 168 participants were presented with a Web-based questionnaire containing a short description of a dentist search scenario and the manipulated reviews for a fictitious dental physician .
METHODS	To investigate the proposed hypotheses , we carried out moderated regression analyses and a moderated mediation analysis using the PROCESS macro 2.11 for SPSS version 22 .
RESULTS	Our analyses indicated that a higher number of reviews resulted in a more positive attitude toward the rated physician .
RESULTS	The results of the regression model for attitude toward the physician suggest a positive main effect of the number of reviews ( mean [ low ] 3.73 , standard error [ SE ] 0.13 , mean [ high ] 4.15 , SE 0.13 ) .
RESULTS	We also observed an interaction effect with the style of the reviewif the physician received only a few reviews , fact-oriented reviews ( mean 4.09 , SE 0.19 ) induced a more favorable attitude toward the physician compared to emotional reviews ( mean 3.44 , SE 0.19 ) , but there was no such effect when the physician received many reviews .
RESULTS	Furthermore , we found that review style also affected the perceived expertise of the reviewer .
RESULTS	Fact-oriented reviews ( mean 3.90 , SE 0.13 ) lead to a higher perception of reviewer expertise compared to emotional reviews ( mean 3.19 , SE 0.13 ) .
RESULTS	However , this did not transfer to the attitude toward the physician .
RESULTS	A similar effect of review style and number on the perceived credibility of the review was observed .
RESULTS	While no differences between emotional and factual style were found if the physician received many reviews , a low number of reviews received lead to a significant difference in the perceived credibility , indicating that emotional reviews were rated less positively ( mean 3.52 , SE 0.18 ) compared to fact-oriented reviews ( mean 4.15 , SE 0.17 ) .
RESULTS	Our analyses also showed that perceived credibility of the review fully mediated the observed interaction effect on attitude toward the physician .
CONCLUSIONS	Physician-rating websites are an interesting new source of information about the quality of health care from the patient 's perspective .
CONCLUSIONS	This paper makes a unique contribution to an understudied area of research by providing some insights into how people evaluate online reviews of individual doctors .
CONCLUSIONS	Information attributes , such as review style and review number , have an impact on the evaluation of the review and on the patient 's attitude toward the rated doctor .
CONCLUSIONS	Further research is necessary to improve our understanding of the influence of such rating sites on the patient 's choice of a physician .

###24486335
BACKGROUND	Subcutaneous ondansetron facilitated by recombinant human hyaluronidase PH20 ( rHuPH20 ) is an alternative for treating nausea/vomiting in patients who can not receive ondansetron by other routes of administration .
OBJECTIVE	Based on preclinical results in minipigs , a Phase I study was designed to assess the tolerability and pharmacokinetic properties of subcutaneous ondansetron + rHuPH20 compared with intramuscular , intravenous , or oral ondansetron monotherapy in healthy volunteers .
METHODS	In a crossover design , 3 minipigs were dosed with subcutaneous ondansetron 0.08 mg/kg + rHuPH20 , or as intramuscular or intravenous monotherapy , for the evaluation of plasma ondansetron concentrations and local tolerability .
METHODS	In a randomized , open-label , 4-way crossover study , subjects received a randomized sequence of SC ondansetron 4 mg + rHuPH20 , or ondansetron monotherapy IM ( 4 mg ) , IV ( 4 mg ) , or PO ( 8 mg ) , over 4 daily visits .
METHODS	Study participants included healthy volunteers aged 19 to 65 years with adequate venous access in both upper extremities and no history of QT-interval prolongation .
METHODS	Primary tolerability end points ( administration-site observations , systemic adverse events [ AEs ] , and subject-assessed pain ) were assessed , and pharmacokinetic parameters ( AUC , Cmax , Tmax , t ) were computed to compare relative rate and extent of systemic exposure .
METHODS	Results were described using summary statistics , and bioequivalence was determined with a linear mixed-effects model .
RESULTS	In the preclinical study , no adverse events or significant local reactions were observed .
RESULTS	The Cmax ( 45.8 ng/mL at 0.08 hour ) with subcutaneous administration + rHuPH20 was 83 % greater and was achieved 68 % faster than with intramuscular administration ( Cmax = 25 ng/mL at 0.25 hour ) .
RESULTS	In the clinical study , a total of 12 subjects ( 7 women , 5 men ; white majority ; mean age , 44.8 ) were randomized .
RESULTS	The majority of AEs were at the injection site , mild in severity , and transient .
RESULTS	After subcutaneous administration of ondansetron + rHuPH20 , geometric mean Cmax was 35 % higher than with intramuscular ondansetron , 43 % lower than with intravenous ondansetron , and 126 % higher than with oral ondansetron ( corrected for dose ) .
RESULTS	Bioequivalence tests demonstrated that systemic exposure after subcutaneous administration was similar to that after intramuscular or intravenous administration and significantly greater than that after oral administration .
CONCLUSIONS	Subcutaneous ondansetron + rHuPH20 was generally well-tolerated .
CONCLUSIONS	Subcutaneous dosing resulted in an extent of systemic exposure similar to that with intramuscular or intravenous dosing and greater than that with oral administration , and may be an option for clinical administration of ondansetron .
CONCLUSIONS	ClinicalTrials.gov identifier : NCT01572012 .

###25473882
OBJECTIVE	Pharmacokinetics , safety , and tolerability of GSK1265744 ( 744 ) and rilpivirine ( RPV ) ( TMC278 ) were assessed after repeat dosing of long-acting ( LA ) injectable formulations in healthy subjects .
METHODS	Subjects received a 14-day lead-in of oral 744 ( 30 mg/d ) to assess safety and tolerability before injectable administration .
METHODS	Subjects were randomized into 4 cohorts : 800 mg of 744 LA intramuscularly ( IM ) followed by 3 monthly doses of ( 1 ) 200 mg subcutaneously , ( 2 ) 200 mg IM , ( 3 ) 400 mg IM , or ( 4 ) a second injection of 800 mg IM after 12 weeks .
METHODS	Cohorts 2 and 3 also received IM doses of RPV LA at months 3 ( 1200 mg ) and 4 ( 900 or 600 mg ) .
METHODS	Pharmacokinetics and safety were assessed throughout the trial .
RESULTS	Forty-seven subjects enrolled ; 40 received 1 LA injection with 37 completing all planned injections .
RESULTS	Seven subjects discontinued 744 oral ( non-drug-related , n = 6 ; dizziness , n = 1 ) .
RESULTS	The 744 LA and RPV LA injections were generally well tolerated , with grade 1 injection site reactions most commonly reported .
RESULTS	Three subjects discontinued during injection phase ( consent withdrawn , n = 2 ; self-limited rash , n = 1 ) .
RESULTS	There were no grade 3 or 4 adverse events and no clinically significant trends in laboratory abnormalities , electrocardiograms , or vital signs .
RESULTS	All dose cohorts achieved therapeutically relevant plasma concentrations of each drug within 3 days with prolonged exposure over the dosing interval .
RESULTS	Plasma concentrations of 744 exceeded the protein-adjusted IC90 and RPV plasma concentrations and were comparable to steady-state oral RPV 25 mg/d .
CONCLUSIONS	These data support the potential application of dual-therapy 744 LA and RPV LA for treatment of HIV-1 infection .

###24583059
OBJECTIVE	Gluten ingestion leads to small intestinal mucosal injury in patients with celiac disease , necessitating strict life-long exclusion of dietary gluten .
OBJECTIVE	Despite adherence to a gluten-free diet , many patients remain symptomatic and still have small intestinal inflammation .
OBJECTIVE	In this case , nondietary therapies are needed .
OBJECTIVE	We investigated the ability of ALV003 , a mixture of 2 recombinant gluten-specific proteases given orally , to protect patients with celiac disease from gluten-induced mucosal injury in a phase 2 trial .
METHODS	We established the optimal daily dose of gluten to be used in a 6-week challenge study .
METHODS	Then , in the intervention study , adults with biopsy-proven celiac disease were randomly assigned to groups given ALV003 ( n = 20 ) or placebo ( n = 21 ) together with the daily gluten challenge .
METHODS	Duodenal biopsies were collected at baseline and after gluten challenge .
METHODS	The ratio of villus height to crypt depth and densities of intraepithelial lymphocytes were the primary end points .
RESULTS	A daily dose of 2 g gluten was selected for the intervention study .
RESULTS	Sixteen patients given ALV003 and 18 given placebo were eligible for efficacy evaluation .
RESULTS	Biopsies from subjects in the placebo group showed evidence of mucosal injury after gluten challenge ( mean villus height to crypt depth ratio changed from 2.8 before challenge to 2.0 afterward ; P = .0007 ; density of CD3 ( + ) intraepithelial lymphocytes changed from 61 to 91 cells/mm after challenge ; P = .0003 ) .
RESULTS	However , no significant mucosal deterioration was observed in biopsies from the ALV003 group .
RESULTS	Between groups , morphologic changes and CD3 ( + ) intraepithelial lymphocyte counts differed significantly from baseline to week 6 ( P = .0133 and P = .0123 , respectively ) .
RESULTS	There were no statistically significant differences in symptoms between groups .
CONCLUSIONS	Based on a phase 2 trial , the glutenase ALV003 appears to attenuate gluten-induced small intestinal mucosal injury in patients with celiac disease in the context of an everyday gluten-free diet containing daily up to 2 g gluten .
CONCLUSIONS	Clinicaltrial.gov ,
METHODS	NCT00959114 and NCT01255696 .

###24731567
OBJECTIVE	The purpose of this study is to validate the efficacy of intensive statin therapy for patients with atherosclerotic intracranial arterial stenosis ( AICAS ) .
METHODS	In this study , we performed a single-center , randomized , single-blind , parallel-group clinical trial .
METHODS	A total of 120 Chinese patients with AICAS were enrolled and randomly divided into three groups [ low-dose atorvastatin therapy ( LAT , 10mg/day ) , standard-dose atorvastatin therapy ( SAT , 20mg/day ) , and intensive-dose atorvastatin therapy ( IAT , 40mg/day ) groups ] in a 1:1:1 ratio .
METHODS	Evaluation variables , including changes in serum lipid profiles , degree of stenosis , and perfusion-related parameters derived from computed tomography perfusion ( CTP ) imaging from baseline to weeks 26 and 52 , as well as the occurrence of cerebrovascular events during the study period , were used to compare the benefits of these three statin therapies .
RESULTS	After 52 weeks of treatment , improvement of serum lipid profiles , degree of stenosis , and perfusion-related parameters were all significantly better in the IAT group .
RESULTS	In addition , the cumulative probability of cerebrovascular events at 52 weeks was significantly lower in the IAT group than in the LAT group , although there was no statistical difference between the IAT group and the SAT group .
RESULTS	The proportion of patients experiencing any adverse event was similar among the three treatment groups .
RESULTS	Adverse events caused by IAT were generally mild ; no serious adverse events occurred throughout the entire period of study .
CONCLUSIONS	In conclusion , long-term use of IAT appears to be a safe and effective treatment at least for Chinese patients with AICAS .

###24528351
BACKGROUND	Carbohydrate counting ( CHC ) is ack - nowledged by the American Diabetes Association ( ADA ) as an important tool .
OBJECTIVE	To assess the efficacy of photographic educational materials to train adolescents with DM to perform CHC .
METHODS	76 adolescents were randomly divided into two groups of CHC orientation : by means of photographic materials ( Photo ) or by a list of foods ( List ) .
METHODS	One month afterwards , the participants were contacted via telephone to answer questions on CHC to reinforce the training ( Quiz ) .
METHODS	Two days after taking the quiz , required the participants to visit an experimental kitchen to observe food portions in natura and to respond to a questionnaire on the weights in grams or carbohydrate equivalents of these portions .
METHODS	Statistical significance was established at p < 0.05 .
RESULTS	54 adolescents completed the study ( 79.7 % female ) , with 51.8 % allocated to the Photo group and 48.1 % to the List group .
RESULTS	The mean age was 13.8 2.0 years old , and the mean body mass index ( BMI ) was 21.0 3.2 kg/m2 .
RESULTS	The participants had average of 7.9 1.5 years of schooling , while their parents had 8.0 3.8 years .
RESULTS	The knowledge of CHC was similar in both groups before the intervention .
RESULTS	After the intervention , the Photo group achieved a significantly higher hit difference on the CHC assessment test than the List group ( Photo : 2.5 vs List : 1.0 ; p = 0.03 ) .
CONCLUSIONS	The photographic educational material was more effective in helping adolescents with DM understand and learn to perform carbohydrate counting .

###24559015
OBJECTIVE	To investigate the gastric emptying of an oral supplement containing carbohydrate plus whey protein drunk before sedation for gastroscopy .
METHODS	This is a randomized double-blind trial including adult patients ( ages 18-65 ) with a chief complaint of epigastric burning and who were candidates to elective gastroscopy .
METHODS	After overnight fast subjects were randomized to drink 200 mL of an oral nutritional supplement containing maltodextrine in addition to whey protein 150 to 210 min before the gastroscopy ( intervention group , n = 12 ) or to undergo the endoscopic procedure with no supplement ( control group , n = 12 ) .
METHODS	The residual gastric volume ( RGV ) suctioned and measured during the exam was the main endpoint of the study .
RESULTS	There were no complications during all exams .
RESULTS	The median ( range ) fasting time was greater ( P < 0.001 ) in control group ( 770 min , ranging from 660-917 min ) than in the study group ( 175 min ranging from 150 to 210 min ) .
RESULTS	The median ( range ) RGV was similar in between the two groups ( control group : 25 ( 10-70 ) mL versus intervention group : 10 ( 0-100 ) mL ; p = 0.32 ) .
CONCLUSIONS	Gastric emptying 150-210 min after the ingestion of an oral supplement containing carbohydrate plus whey protein is similar to an overnight fasting condition .
CONCLUSIONS	Although limited by the number of cases , the sedation for endoscopic procedures is safe with this fasting protocol .

###24518533
OBJECTIVE	To evaluate effects of an exercise program on health-related quality of life ( HRQoL ) in children and adolescents with tetralogy of Fallot ( ToF ) or a Fontan circulation .
METHODS	Stratified , randomized , controlled intervention study conducted in five participating centers of pediatric cardiology in The Netherlands .
METHODS	In total , 93 patients , aged 10-25 years , with surgical repair for tetralogy of Fallot or with a Fontan circulation for single-ventricle physiology were included .
METHODS	They were randomly allocated with a ratio of 2:1 to : ( 1 ) a 12-week period with an exercise program for 3 times per week or ( 2 ) to a control group .
METHODS	Randomization was stratified by age , gender , and cardiac diagnosis .
METHODS	At baseline and follow-up after 12 weeks , all participants completed Web-based age-appropriate HRQoL questionnaires .
METHODS	Primary analyses involved change in HRQoL during follow-up .
METHODS	Secondary analyses concerned influence of cardiac diagnosis and comparison with normative data .
RESULTS	Forty-eight ( 86 % ) and 32 ( 86 % ) patients in the exercise-group and control-group respectively completed all questionnaires at baseline and follow-up .
RESULTS	Compared with the control-group , children , aged 10-15 years , in the exercise-group improved significantly on self-reported cognitive functioning , p < .05 , r = .30 , and parent-reported social functioning , p < .05 , r = .30 .
RESULTS	Youngsters aged 16-25 years did not change their HRQoL .
RESULTS	Cardiac diagnosis had no influence on pre/post changes .
RESULTS	Children and youngsters in this study reported comparable or better HRQoL than norm groups .
CONCLUSIONS	Participation in an exercise program improved HRQoL of children with ToF or a Fontan circulation , especially in those with low baseline QoL .

###24412523
OBJECTIVE	Heart failure ( HF ) is associated with changes in myocardial metabolism that lead to impairment of contractile function .
OBJECTIVE	Trimetazidine ( TMZ ) modulates cardiac energetic efficiency and improves outcomes in ischemic heart disease .
OBJECTIVE	We evaluated the effects of TMZ on left ventricular ejection fraction ( LVEF ) , cardiac metabolism , exercise capacity , O2 uptake , and quality of life in patients with nonischemic HF .
RESULTS	Sixty patients with stable nonischemic HF under optimal medical therapy were included in this randomized double-blind study .
RESULTS	Patients were randomized to TMZ ( 35 mg orally twice a day ) or placebo for 6 months .
RESULTS	LVEF , 6-minute walk test ( 6MWT ) , maximum O2 uptake in cardiopulmonary exercise test , different markers of metabolism , oxidative stress , and endothelial function , and quality of life were assessed at baseline and after TMZ treatment .
RESULTS	Left ventricular peak glucose uptake was evaluated with the use of the maximum standardized uptake value ( SUV ) by 18-fluorodeoxyglucose positron emission tomography ( ( 18 ) FDG-PET ) .
RESULTS	Etiology was idiopathic in 85 % and hypertensive in 15 % .
RESULTS	Both groups were similar in age , functional class , LVEF , and levels of N-terminal pro-B-type natriuretic peptide at baseline .
RESULTS	After 6 months of TMZ treatment , no changes were observed in LVEF ( 31 10 % vs 34 8 % ; P = .8 ) , 6MWT ( 443 25 m vs 506 79 m ; P = .03 ) , maximum O2 uptake ( 19.1 5.0 mL kg ( -1 ) min ( -1 ) vs 23.0 7.2 mL kg ( -1 ) min ( -1 ) ; P = .11 ) , functional class ( percentages of patients in functional classes I/II/III / IV 10/3753/0 vs 7/40/50 / 3 ; P = .14 ) , or quality of life ( 32 26 points vs 24 18 points ; P = .25 ) in TMZ versus placebo , respectively .
RESULTS	In the subgroup of patients evaluated with ( 18 ) FDG-PET , no significant differences were observed in SUV between both groups ( 7.0 3.6 vs 8.2 3.4 respectively ; P = .47 ) .
CONCLUSIONS	In patients with nonischemic HF , the addition of TMZ to optimal medical treatment does not result in significant changes of LVEF , exercise capacity , O2 uptake , or quality of life .

###24393576
BACKGROUND	The aim of this study was to investigate the efficacy of catheter ablation in the treatment of persistent atrial fibrillation ( AF ) and the predictors of arrhythmia recurrence .
METHODS	Absence of atrial tachyarrhythmia ( AT ) recurrence during a mid-term follow-up was correlated with several clinical and procedural characteristics in a population of 82 patients aged 20-70 years who had experienced at least one documented relapse of persistent AF during a single trial of antiarrhythmic drug therapy .
METHODS	Electrophysiological success of ablation was declared when all identified PVs were isolated ( confirmation of entry and exit block ) .
METHODS	Patients were followed for a maximum of 24 months after the blanking period with outpatient visits , ECG recordings , 24-hour Holter monitoring , and weekly transtelephonic monitoring for 30s .
RESULTS	Electrophysiological success was documented in 38/82 ( 46.3 % ) patients .
RESULTS	During a mean follow-up of 24.7 4.2 months , 69/82 ( 84.1 % ) patients presented at least one episode of AT after the 2 month blanking period .
RESULTS	According to univariate and multivariate logistic regression analyses , only an electrophysiologically successful ablation significantly correlated with the absence of documented AT relapse ( OR 5.32 , 95 % CL 1.02-27 .72 ; p = .0472 ) .
CONCLUSIONS	Mid-term outcome of a single procedure of catheter ablation without the adjunction of antiarrhythmic drug therapy is poor in patients with persistent AF .
CONCLUSIONS	Documented PV isolation is useful to increase the success rate of circumferential PV ablation even in persistent AF patients .

###25603666
BACKGROUND	Delayed primary closure in cases of acute appendicitis is debated among the surgeons as to whether it decreases the rate of wound infection in comparison to primary closure .
BACKGROUND	The aim of this study was to find out the optimal method of wound closure in cases of perforated appendicitis .
METHODS	This randomized control trial was conducted at the surgical units of Ayub Teaching Hospital Abbottabad from May to November 2012 .
METHODS	A total of 158 patients having perforated appendicitis were included in the study .
METHODS	They were randomly divided two groups .
METHODS	The wounds were primarily closed in one group and left open with daily saline soaked dressing , to be closed on postoperative day 4 in case of the other group .
METHODS	The main outcome measure was wound infection .
METHODS	A wound was considered infected if it was discharging pus , was red and swollen on postoperative day 8th .
METHODS	The method of wound closure was considered efficacious if there was no wound infection till 8th postoperative day .
RESULTS	A total of 158 patients , 56 ( 35.4 % ) male and 102 ( 64.6 % ) female were included in the study .
RESULTS	Primary closure group had a total number of 79 patients with 26 ( 32.9 % ) male and 53 ( 67.1 % ) female .
RESULTS	Delayed primary group had also a total number of 79 patients with 30 ( 38 % ) male and 49 ( 62 % ) female .
RESULTS	The mean age of patients in the primary closure group was 26.67 7.32 years while in the delayed primary group was 28.15 6.88 years .
RESULTS	In the entire series , 36 ( 22.8 % ) patients developed wound infection .
RESULTS	There was a significant association between wound infection and type of skin closure ( Delayed Primary Closure 6.3 % vs. Primary Closure 39.2 % , p < 0.000 ) .
CONCLUSIONS	Delayed Primary closure is the optimal management strategy in case of perforated appendicitis as it decreases the incidence of wound infection .

###24402336
OBJECTIVE	this study aimed to evaluate the efficacy of hand hygiene performed with two different soap formulations : 0.3 % Melaleuca alternifolia essential oil versus 0.5 % triclosan , and to compare them with two reference hygiene procedures : the official methodology procedure ( soft soap ) versus the draft version of the procedure ( soft soap + propan-2-ol ) .
METHODS	using the European EN 1499 method , logarithmic reduction factors were determined for the number of colony forming units of Escherichia coli K12 before and after hand hygiene of 15 volunteer subjects , and compared using the one-tailed Wilcoxon test .
RESULTS	referring to the soft soap , there was no difference between the performance of soap with 0.3 % M. alternifolia and soap containing 0.5 % triclosan .
RESULTS	The soft soap + propan-2-ol proved to be more effective than the other hand hygiene procedures .
CONCLUSIONS	studies to verify the therapeutic efficacy of essential oil in hand hygiene can improve adherence to this practice .

###25807800
OBJECTIVE	To identify the effects of ingested anti-rotavirus immunoglobulin on enteric expressions of SIgA in pediatric rotavirus enteritis .
METHODS	In this randomized , placebo controlled clinic trial , 100 patients of pediatric rotavirus enteritis who simultaneously received fluid replacement as basic therapy , were randomly divided into control and immunoglobulin treated groups .
METHODS	The patients in experimental group were given `` ingested antirotavirus IgY '' .
METHODS	Stool sample was collected at day 1 , 3 , 5 , 7 , 9 and 11 , the level of fecal SIgA was quantifies by radioimmunoassay kit , and fecal rotavirus shedding was detected by double-sandwich ELISA .
RESULTS	The frequency of diarrhea in immunoglobulin group was obviously less than that in control group ( P < 0.05 ) .
RESULTS	The mean course of diarrhea was ( 4.5 + / - 0.92 ) d in immunoglobulin group , and ( 5.8 + / - 1.68 ) d in control group ( P = 0.015 ) .
RESULTS	The fecal SIgA level in immunoglobulin group was higher than that in control group ( P < 0.05 ) .
RESULTS	The doubling time of SIgA level was the 3rd d in immunoglobulin group , and the 5th d in control group .
RESULTS	The fecal rotavirus shedding in immunoglobulin group was obviously lower than that in control group ( P < 0.05 ) .
CONCLUSIONS	Ingested anti-rotavirus immunoglobulin could promote the expression of enteric SIgA to remove rotavirus , achieving the benefit to release diarrhea in pediatric rotavirus enteritis .

###24621936
OBJECTIVE	This study sought to evaluate the efficacy and safety of long-term growth hormone ( GH ) replacement therapy in GH-deficient patients with chronic heart failure ( CHF ) .
BACKGROUND	Recent evidence indicates that growth hormone deficiency ( GHD ) affects as many as 40 % of patients with CHF , and short-term GH replacement causes functional benefit .
BACKGROUND	Whether long-term GH replacement also affects CHF progression is unknown .
METHODS	The study is an extension of a previous randomized , controlled single-blind trial that screened 158 consecutive CHF patients ( New York Heart Association classes II to IV ) and identified 63 who had GHD by the growth hormone releasing hormone plus arginine test .
METHODS	Fifty-six patients were randomized to receive either GH therapy or standard CHF therapy .
METHODS	Patients were evaluated at baseline and after a 4-year follow-up .
METHODS	The primary endpoint was peak oxygen consumption ( VO2 ) .
METHODS	Secondary endpoints included left ventricular ( LV ) ejection fraction and volumes , serum amino terminal fragment of the pro-hormone brain-type natriuretic peptide , quality of life , and safety .
RESULTS	Seventeen patients in the GH group and 14 in the control group completed the study .
RESULTS	In the GH group , peak VO2 improved over the 4-year follow-up .
RESULTS	The treatment effect was 7.1 0.7 ml/kg/min versus -1.8 0.5 ml/kg/min in the GH and control groups , respectively .
RESULTS	At 4 years , LV ejection fraction increased by 10 3 % in the GH group , whereas it decreased by 2 5 % in control patients .
RESULTS	The treatment effect on LV end-systolic volume index was -22 6 ml and 8 3 ml/m ( 2 ) in the GH and control groups , respectively ( all p < 0.001 ) .
RESULTS	No major adverse events were reported in the patients who received GH .
CONCLUSIONS	Although this is a preliminary study , the finding suggests a new therapeutic approach to a large proportion of GHD patients with CHF .

###24829493
BACKGROUND	It is well recognized that amounts of trans and saturated fats should be minimized in Western diets ; however , considerable debate remains regarding optimal amounts of dietary n-9 , n-6 , and n-3 fatty acids .
OBJECTIVE	The objective was to examine the effects of varying n-9 , n-6 , and longer-chain n-3 fatty acid composition on markers of coronary heart disease ( CHD ) risk .
METHODS	A randomized , double-blind , 5-period , crossover design was used .
METHODS	Each 4-wk treatment period was separated by 4-wk washout intervals .
METHODS	Volunteers with abdominal obesity consumed each of 5 identical weight-maintaining , fixed-composition diets with one of the following treatment oils ( 60 g/3000 kcal ) in beverages : 1 ) conventional canola oil ( Canola ; n-9 rich ) , 2 ) high-oleic acid canola oil with docosahexaenoic acid ( CanolaDHA ; n-9 and n-3 rich ) , 3 ) a blend of corn and safflower oil ( 25:75 ) ( CornSaff ; n-6 rich ) , 4 ) a blend of flax and safflower oils ( 60:40 ) ( FlaxSaff ; n-6 and short-chain n-3 rich ) , or 5 ) high-oleic acid canola oil ( CanolaOleic ; highest in n-9 ) .
RESULTS	One hundred thirty individuals completed the trial .
RESULTS	At endpoint , total cholesterol ( TC ) was lowest after the FlaxSaff phase ( P < 0.05 compared with Canola and CanolaDHA ) and highest after the CanolaDHA phase ( P < 0.05 compared with CornSaff , FlaxSaff , and CanolaOleic ) .
RESULTS	Low-density lipoprotein ( LDL ) cholesterol and high-density lipoprotein ( HDL ) cholesterol were highest , and triglycerides were lowest , after CanolaDHA ( P < 0.05 compared with the other diets ) .
RESULTS	All diets decreased TC and LDL cholesterol from baseline to treatment endpoint ( P < 0.05 ) .
RESULTS	CanolaDHA was the only diet that increased HDL cholesterol from baseline ( 3.5 1.8 % ; P < 0.05 ) and produced the greatest reduction in triglycerides ( -20.7 3.8 % ; P < 0.001 ) and in systolic blood pressure ( -3.3 0.8 % ; P < 0.001 ) compared with the other diets ( P < 0.05 ) .
RESULTS	Percentage reductions in Framingham 10-y CHD risk scores ( FRS ) from baseline were greatest after CanolaDHA ( -19.0 3.1 % ; P < 0.001 ) than after other treatments ( P < 0.05 ) .
CONCLUSIONS	Consumption of CanolaDHA , a novel DHA-rich canola oil , improves HDL cholesterol , triglycerides , and blood pressure , thereby reducing FRS compared with other oils varying in unsaturated fatty acid composition .
CONCLUSIONS	This trial was registered at www.clinicaltrials.gov as NCT01351012 .

###24265189
OBJECTIVE	To assess short - and long-term outcomes of pregnant women with very early rupture of membranes randomized to serial amnioinfusion or expectant management , and to collect data to inform a larger , more definitive clinical trial .
METHODS	This was a prospective non-blinded randomized controlled trial with randomization stratified for pregnancies in which the membranes ruptured between 16 +0 and 19 +6 weeks ' gestation and 20 +0 and 23 +6 weeks ' gestation to minimize the risk of random imbalance in gestational age distribution between randomized groups .
METHODS	Intention-to-treat analysis was used .
METHODS	The study was conducted in four UK hospital-based fetal medicine units ( Liverpool Women 's NHS Trust , St Mary 's Hospital Manchester , Birmingham Women 's NHS Foundation Trust and Wirral University Hospitals Trust ) .
METHODS	The participants were women with confirmed preterm prelabor rupture of membranes at 16 +0 to 24 +0 weeks ' gestation .
METHODS	Women with multiple pregnancy , fetal abnormality or obstetric indication for immediate delivery were excluded .
METHODS	Participants were randomly allocated to either serial weekly transabdominal amnioinfusions if the deepest pool of amniotic fluid was < 2cm or expectant management until 37 weeks ' gestation .
METHODS	Short-term maternal , pregnancy and neonatal and long-term outcomes for the child were studied .
METHODS	Long-term respiratory morbidity was assessed using validated respiratory questionnaires at 6 , 12 and 18 months of age and infant lung function test at around 12 months of age .
METHODS	Neurodevelopment was assessed using the Bayley Scales of Infant Development , second edition ( BSID-II ) at corrected age of 2 years .
RESULTS	Fifty-eight women were randomized to the study .
RESULTS	Two babies were excluded from the analysis because of termination of pregnancy for lethal anomaly , leaving 56 participants ( 28 assigned to serial amnioinfusion and 28 to expectant management ) recruited between 2002 and 2009 .
RESULTS	There was no significant difference in perinatal mortality ( 19/28 vs 19/28 ; relative risk ( RR ) 1.0 ( 95 % CI , 0.70-1 .43 ) ) and maternal or neonatal morbidity .
RESULTS	The overall chance of surviving without long-term respiratory or neurodevelopmental disability was 4/56 ( 7.1 % ) ; 4/28 ( 14.3 % ) in the amnioinfusion group and 0/28 in the expectant group ( RR 9.0 ( 95 % CI , 0.51-159 .70 ) ) .
CONCLUSIONS	This pilot study found no major differences in maternal , perinatal or pregnancy outcomes .
CONCLUSIONS	The study was not designed to show a difference between the groups and the number of survivors was too small to draw any conclusions about long-term outcomes .
CONCLUSIONS	It does , however , signal that a larger definitive study to evaluate amnioinfusion for improvement in healthy survival is needed .
CONCLUSIONS	The pilot suggests that , with appropriate funding , such a study is feasible .

###25910292
OBJECTIVE	We investigated the risk of abdominal operation in patients with fatty liver and the risk of any cancer in first-degree relatives of patients with fatty liver .
METHODS	We evaluated 105 patients with nonalcoholic fatty liver disease ( NAFLD ) , 121 patients with biopsy-proven hepatitis C ( 61 patients with fatty liver and 60 patients without fatty liver ) , 50 patients with inflammatory bowel disease ( IBD ) , and 109 patients with dyspepsia .
RESULTS	There was no difference in sex , mean age , and marital status among the groups except that patients with IBD were younger than the others ( p < 0.001 ) .
RESULTS	The frequency of cancer among family members was 18 % in IBD , 9 % in dyspepsia , 28 % in hepatitis C with steatosis , 21.5 % in hepatitis C without steatosis , and 27 % in NAFLD ( p = 0.006 ) .
RESULTS	Then , we divided the study group into two groups as follows : group 1 : ( IBD + dyspepsia + hepatitis C without steatosis ) and group 2 : ( hepatitis C with steatosis + NAFLD ) .
RESULTS	We found that the frequency of cancer was 16 % in group 1 versus 24.4 % in group 2 ( p = 0.037 ) .
RESULTS	We also investigated the risk of abdominal operation in patients with fatty liver .
RESULTS	The results were as follows : 33 % in group without fatty liver versus 43 % in group with fatty liver ( p = 0.043 ) .
CONCLUSIONS	Understanding the underlying causes of fatty liver forms might decrease the cancer frequency in the population and number of operations in patients with fatty liver .

###24886488
BACKGROUND	Chronic kidney disease ( CKD ) is common and increasing in prevalence .
BACKGROUND	Cardiovascular disease ( CVD ) is a major cause of morbidity and death in CKD , though of a different phenotype to the general CVD population .
BACKGROUND	Few therapies have proved effective in modifying the increased CVD risk or rate of renal decline in CKD .
BACKGROUND	There are accumulating data that aldosterone receptor antagonists ( ARA ) may offer cardio-protection and delay renal impairment in patients with the CV phenotype in CKD .
BACKGROUND	The use of ARA in CKD has therefore been increasingly advocated .
BACKGROUND	However , no large study of ARA with renal or CVD outcomes is underway .
METHODS	The study is a prospective randomised open blinded endpoint ( PROBE ) trial set in primary care where patients will mainly be identified by their GPs or from existing CKD lists .
METHODS	They will be invited if they have been formally diagnosed with CKD stage 3b or there is evidence of stage 3b CKD from blood results ( eGFR 30-44mL / min/1 .73 m2 ) and fulfil the other inclusion/exclusion criteria .
METHODS	Patients will be randomised to either spironolactone 25mg once daily in addition to routine care or routine care alone and followed-up for 36months .
CONCLUSIONS	BARACK D is a PROBE trial to determine the effect of ARA on mortality and cardiovascular outcomes ( onset or progression of CVD ) in patients with stage 3b CKD .
BACKGROUND	EudraCT : 2012-002672-13ISRTN : ISRCTN44522369 .

###25451890
OBJECTIVE	To assess changes in circulating incretin levels and body fat compositions with initial combination therapy with - glucosidase inhibitor and dipeptidyl peptidase-4 inhibitor in patients with type 2 diabetes ( T2D ) .
METHODS	In this multicenter open-label 24-week trial , Japanese over-weight ( BMI 25 kg/m ( 2 ) ) patients with T2D not taking medication or taking metformin and/or sulfonylurea were randomly assigned to receive either 50mg of miglitol three times a day ( M , n = 14 ) , 50mg of sitagliptin once a day ( S , n = 14 ) , or a combination of both ( M+S , n = 13 ) .
METHODS	Changes in plasma incretin levels during a meal tolerance test ( MTT ) and body fat composition with impedance method were evaluated .
RESULTS	During MTT , postprandial plasma glucose levels decreased more after M+S than after M or S , and postprandial serum insulin levels decreased significantly after M and M+S whereas they increased after S.
RESULTS	After M , active gastric inhibitory polypeptide ( aGIP ) decreased significantly at 30 min despite a significant increase at 120 min .
RESULTS	After S , aGIP levels increased significantly throughout the MTT .
RESULTS	After M+S , aGIP increased significantly at 0 and 120 min despite of significant decrease at 30 min .
RESULTS	M+S further enhanced postprandial active glucagon-like peptide-1 levels during MTT than S did .
RESULTS	Total body fat mass decreased significantly after M and M+S .
RESULTS	Visceral fat mass decreased significantly only after M+S .
RESULTS	Serum adiponectin increased significantly only after M+S .
CONCLUSIONS	In over-weight patients with T2D , M+S may have a beneficial effect on adiposity with relation to these different effects on two incretins .

###25876343
OBJECTIVE	To observe the effect differences on post-stroke dysphagia among acupoint injection combined with neural electrical stimulation , acupoint injection , neural electrical stimulation , and swallowing training respectively , so eligible intervention can be applied to this kind of disease .
METHODS	One hundred and eight-three patients of post-stroke dysphagia were randomized into a comprehensive treatment group ( 42 cases ) , an acupoint injection group ( 44 cases ) , a neural electrical stimulation group ( 49 cases ) and a swallow training group ( 48 cases ) and were treated with the comprehensive therapy of acupoint injection and neural electrical stimulation , acupoint injection , neural electrical stimulation and swallowing training separately .
METHODS	The treatments for 10 days made one session .
METHODS	There were 3 days at the interval among treatment sessions and 3 sessions were required totally .
METHODS	The cases in those treatment groups were blankly controlled with the other 47 patients of post-stroke dysphagia .
METHODS	All the patients received basic rehabilitation treatment .
METHODS	The modified water swallowing test was conducted to assess the efficacy before treatment , 10 days after treatment and 30 days after treatment in each group separately .
METHODS	The clinical efficacy , score of water swallowing test and improvement in water swallow test were compared among the groups .
RESULTS	After 10-day treatment , the differences in efficacy and score of water swallow test were not significant in each group ( all P > 0.05 ) .
RESULTS	After 30-day treatment , the effective rate ( 94.29 % , 33/35 ) in the comprehensive treatment group was apparently better than 68.75 % ( 22/32 ) in the acupoint injection group , 80.00 % ( 32/40 ) in the neural electrical stimulation group , 67.50 % ( 27/40 ) in the swallowing training group and 42.86 % ( 12/28 ) in the blank group separately .
RESULTS	The score in water swallow test in the comprehensive treatment group was lower than that in each of the other groups ( 1.37 0.60 vs 2.03 1.00 , 1.90 0.90 , 2.20 0.72 , 2.71 0.90 , all P < 0.05 ) .
RESULTS	The differences in the effective rate and score in water swallow test were not significant among the acupoint injection group , neural electrical stimulation group and swallowing training group ( all P > 0.05 ) , which indicated that the improvement in swallowing function in the comprehensive treatment group was significantly superior to the other groups ( all P < 0.05 ) .
CONCLUSIONS	The comprehensive therapy of acupoint injection and neural electrical stimulation achieves the much better efficacy on post-stroke dysphagia .

###24923685
OBJECTIVE	To evaluate the impact of a 91-day extended regimen combined oral contraceptive ( 150 g levonorgestrel [ LNG ] / 30 g ethinylestradiol [ EE ] for 84 days , followed by 10 g EE for seven days [ Treatment 1 ] ) compared with two traditional 21/7 regimens ( 21 days 150 g LNG/30 g EE [ Treatment 2 ] or 150 g desogestrel [ DSG ] / 30 g EE [ Treatment 3 ] , both with seven days ' hormone free ) , on several coagulation factors and thrombin formation markers .
METHODS	Randomised , open-label , parallel-group comparative study involving healthy women ( 18-40 years ) .
METHODS	The primary endpoint was change from baseline in prothrombin fragment 1 + 2 ( F1 + 2 ) levels over six months .
RESULTS	A total of 187 subjects were included in the primary analysis .
RESULTS	In all groups , mean F1 + 2 values were elevated after six months of treatment .
RESULTS	Changes were comparable between Treatments 1 and 2 ( least squares mean change : 170 pmol/L and 158 pmol/L , respectively ) but noticeably larger after Treatment 3 ( least squares mean change : 592 pmol/L ) .
RESULTS	The haemostatic effects of Treatment 1 were comparable to those of Treatment 2 and noninferior to those of Treatment 3 ( lower limit of 95 % confidence interval [ - 18.3 pmol/L ] > - 130 pmol/L ) .
CONCLUSIONS	The LNG/EE regimens had similar effects on F1 + 2 .
CONCLUSIONS	Noninferiority was demonstrated between extended regimen LNG/EE and DSG/EE .

###25200640
OBJECTIVE	To investigate whether the type of anesthetic agent administered affects the antitussive effect of remifentanil .
METHODS	Prospective randomized study .
METHODS	Operating room of a university hospital .
METHODS	78 ASA physical status 1 and 2 women , aged 20 to 65 years , who were scheduled to undergo a thyroidectomy .
METHODS	Patients were randomly assigned to three groups to receive anesthesia with propofol ( Group P ) , sevoflurane ( Group S ) , or desflurane ( Group D ) .
METHODS	The main anesthetics were titrated to maintain a target Bispectral Index for hypnosis of 40 to 60 .
METHODS	Remifentanil was administered via effect-site target-controlled infusion ( TCI ) .
METHODS	To determine the effective remifentanil effect-site concentration ( Ce ) to suppress coughing in each group , the up-and-down sequential allocation design was used .
METHODS	The half maximal effective concentration ( EC50 ) values of remifentanil for preventing coughing in the groups were estimated using isotonic regression and compared among the groups .
RESULTS	The EC50 of remifentanil for cough suppression in Group P [ 1.60 ng/mL ( 98.3 % CI , 0.92-1 .75 ng/mL ) ] was statistically lower than in Group D [ 1.96 ng/mL ( 98.3 % CI , 1.81-2 .50 ng/mL ) ] .
RESULTS	The EC50 in Group S was 1.75 ng/mL ( 98.3 % CI , 1.39-2 .13 ng/mL ) , which was higher than in Group P and lower than in Group D , but did not differ significantly from either group .
CONCLUSIONS	Remifentanil administration for cough suppression during emergence should be customized to the anesthetic agent .

###24686884
BACKGROUND	It is important that patients are well-informed about risks and benefits of therapies to help them decide whether to accept medical therapy .
BACKGROUND	Different numerical formats can be used in risk communication but It remains unclear how the different formats affect decisions made by real-life patients .
OBJECTIVE	To compare the impact of using Prolongation Of Life ( POL ) and Absolute Risk Reduction ( ARR ) information formats to express effectiveness of cholesterol-lowering therapy on patients ' redemptions of statin prescriptions , and on patients ' confidence in their decision and satisfaction with the risk communication .
METHODS	Cluster-randomised clinical trial in general practices .
METHODS	Thirty-four Danish GPs from 23 practices participated in a primary care-based clinical trial concerning use of quantitative effectiveness formats for risk communication in health prevention consultations .
METHODS	GPs were cluster-randomised ( treating practices as clusters ) to inform patients about cardiovascular mortality risk and the effectiveness of statin treatment using either POL or ARR formats .
METHODS	Patients ' redemptions of statin prescriptions were obtained from a regional prescription database .
METHODS	The COMRADE questionnaire was used to measure patients ' confidence in their decision and satisfaction with the risk communication .
RESULTS	Of the 240 patients included for analyses , 112 were allocated to POL information and 128 to ARR .
RESULTS	Patients redeeming a statin prescription totalled six ( 5.4 % ) when informed using POL , and 32 ( 25.0 % ) when using ARR .
RESULTS	The level of confidence in decision and satisfaction with risk communication did not differ between the risk formats .
CONCLUSIONS	Patients redeemed statin prescriptions less often when their GP communicated treatment effectiveness using POL compared with ARR .

###25627076
BACKGROUND	Although hydroxyethyl starch ( HES ) is commonly used as an intravascular volume expander in surgical patients , recent studies suggest that it may increase the risk of renal failure in critically ill patients .
BACKGROUND	We hypothesized that patients undergoing radical prostatectomy and receiving HES would be more likely to develop markers of renal failure , such as increasing urinary neutrophil gelatinase-associated lipocalin ( u-NGAL ) , creatinine clearance ( C ( crea ) ) , and decreasing urine output ( UO ) .
METHODS	In a randomized , double-blinded , placebo-controlled study , 40 patients referred for radical prostatectomy received either 6 % HES 130/0 .4 or saline 0.9 % ; 7.5 mL/kg during the first hour of surgery and 5 mL/kg in the following hours ; u-NGAL , urine albumin , C ( crea ) , UO , arterial blood pressure , and plasma concentrations of creatinine , renin , angiotensin II , aldosterone , and vasopressin were measured before , during , and after surgery .
RESULTS	Thirty-six patients completed the study .
RESULTS	u-NGAL , C ( crea ) , UO , plasma neutrophil gelatinase-associated lipocalin , p-creatinine , urine albumin , and arterial blood pressure were the same in both groups .
RESULTS	Blood loss was higher in the HES group ( HES 1250 vs saline 750 mL ) , while p-albumin was reduced to a significantly lower level .
RESULTS	P-renin and p-angiotensin-II increased in both groups , whereas p-aldosterone and p-vasopressin increased significantly in the saline group .
CONCLUSIONS	We found no evidence of nephrotoxicity after infusion of 6 % HES 130/0 .4 in patients undergoing prostatectomy with normal preoperative renal function .
CONCLUSIONS	Hemodynamic stability and infused fluid volume were the same in both groups .
CONCLUSIONS	We observed an increased blood loss in the group given 6 % HES 130/0 .4 .

###25478975
BACKGROUND	Nasotracheal intubation of patients with temporomandibular joint ( TMJ ) ankylosis is a challenge for anesthesiologists .
BACKGROUND	Awake fiberoptic intubation ( AFOI ) is the safest technique in patients with difficult airway .
BACKGROUND	This study compares 3 different techniques of conscious sedation during AFOI in patients with TMJ ankylosis .
METHODS	This study comprised 54 patients , American Society of Anesthesiologists physical status 1 , scheduled for TMJ surgery .
METHODS	The patients were randomly allocated to remifentanil group ( n = 18 , 0.75 g/kg over 30 seconds ) , ketamine group ( n = 18 , 0.25 mg/kg over 30 seconds ) , or propofol group ( n = 18 , 0.5 mg/kg over 30 seconds ) for conscious sedation .
METHODS	The main determinants affecting the patient 's outcome included intubation time , intubation conditions , and patient discomfort , which were determined by scoring system .
METHODS	In addition , postoperative patient dissatisfaction , hemodynamic stability , and respiratory impairment were measured .
RESULTS	Intubation times were significantly different between groups ( P < 0.001 ) , where remifentanil had the shortest time ( 30.28 seconds ) .
RESULTS	Intubation conditions ( scores 0-3 ) were significantly different between groups ( P < 0.001 ) .
RESULTS	In this context , remifentanil had score 3 ( 2-3 ) , which was higher compared with 2 ( 1-3 ) for ketamine and 2 ( 1-2 ) for propofol .
RESULTS	Patient discomfort score was lowest in the remifentanil group .
RESULTS	Hemodynamic stability was maintained within groups , and its changes were not significant ( P > 0.05 ) .
RESULTS	Postoperative patient 's dissatisfaction was observed in 2 , 3 , and 5 patients in remifentanil , ketamine , and propofol groups , respectively .
RESULTS	Respiratory impairment ( apnea ) recorded lowest in the remifentanil group .
CONCLUSIONS	Remifentanil was the best agent for AFOI , because it provided shorter intubation time , better intubation conditions , and least patient 's complaint.Iranian registry no. : IRCT 201208061674N4 ( www.irct.ir ) .

###24802722
OBJECTIVE	AZD7325 is a novel 2,3 - subtype-selective partial GABA-A-receptor modulator .
OBJECTIVE	This study investigated the pharmacodynamics of single oral doses of AZD7325 2mg and 10mg on the central nervous system ( CNS ) compared with placebo and lorazepam 2mg .
METHODS	This double-blind , randomized , four way crossover study enrolled 16 healthy males and administered two validated CNS test batteries to measure drug effects on cognitive , neurophysiologic and psychomotor function and subjective feelings .
METHODS	The pharmacological selectivity of AZD7325 was compared with lorazepam by plotting saccadic peak velocity change from baseline ( SPV ) against body sway ( Sway ) and visual analogue scale for alertness ( VASalertness ) .
METHODS	This analysis has previously been used to identify 2,3 - subtype-selectivity .
RESULTS	In contrast with the robust impairment caused by lorazepam ( all P < 0.05 vs. placebo ) , neither dose of AZD7325 induced statistically significant effects on any pharmacodynamic measurements .
RESULTS	Lorazepam-induced SPV-reduction was linearly related to changes in other neurophysiologic biomarkers .
RESULTS	In contrast , the slopes of the regression lines were flatter for AZD7325 , particularly for the log ( Sway ) - SPV relation ( estimate slope , AZD7325 10mg vs. lorazepam , difference [ 95 % confidence interval ] , P value -0.00036 vs. -0.00206 , 0.001704 [ 0.000639 , 0.002768 ] , P = 0.0018 ) and the VASalertness - SPV relationship ( 0.01855 vs. 0.08216 , -0.06360 [ -0.1046 , -0.02257 ] , P = 0.0024 ) .
RESULTS	AZD7325 10mg and lorazepam induced different response patterns on VAS ` feeling high ' and electro-encephalography .
CONCLUSIONS	The characteristic SPV-relative effect profiles of AZD7325 vs. lorazepam suggest anxio-selectivity related to 2,3 - selective GABAA agonism .
CONCLUSIONS	However , exploration of higher doses may be warranted .
CONCLUSIONS	The paucity of effects on most CNS-PD parameters also indicates a mitigated side effect pattern , with potentially lower cognitive and neurophysiological side effect burden than non-selective benzodiazepines .

###25471366
BACKGROUND	Healthcare providers ( HCPs ) play a critical role in controlling the spread of sexually transmitted infections ( STI ) through early and accurate diagnosis , appropriate treatment and prevention counselling .
BACKGROUND	This study aimed to assess the effectiveness of an educational intervention about STI on knowledge and reported practice among HCPs and to explore which determinants may influence the intervention 's effects .
METHODS	A cluster randomized controlled educational intervention was carried out in a rural district , Vietnam .
METHODS	32 communes of the district were randomized into two arms , with 160 HCPs in an STI intervention arm and 144 in a control arm .
METHODS	The STI intervention comprised interactive training with basic STI knowledge , case scenarios , and poster distribution .
METHODS	Questionnaires to evaluate knowledge and reported practice were completed three times : before , during and after the intervention .
METHODS	Correct answer was scored as 1 ; `` do not know '' , incorrect answer was scored as 0 .
METHODS	Univariate and multilevel multivariate analyses were applied .
RESULTS	Of the maximum 56 points , the mean knowledge score increased significantly in the STI intervention arm and in the control arm post-intervention ( 37.2 to 48.4 , and 32.7 to 41.7 , respectively ) .
RESULTS	In multivariate regression analysis , knowledge improvement in the intervention arm was significantly higher than that in the control arm ( regression coefficient = 2.97 , p = 0.008 ) .
RESULTS	Other factors which positively influenced the increase in knowledge were being between 35 and 50 years old , having intermediate professional training , being a pharmacist or working at a village level ( regression coefficient : 2.81 , 4.43 , 5.53 and 7.91 , respectively ) .
RESULTS	Post-intervention , the mean reported practice score increased significantly in the STI intervention arm ( from 17.6 to 21.8 ) and insignificantly in the control arm ( maximum 36 points ) .
RESULTS	Factors which positively influenced the increase in reported practice were being between 35 and 50 years old , having intermediate professional training , or working at a pharmacy/drugstore ( regression coefficient : 2.15 , 3.33 and 3.22 , respectively ) .
CONCLUSIONS	This study indicates that an educational intervention including interactive training and multi-faceted interventions may be effective in improving STI knowledge and reported practice of HCPs at grassroots level , particularly among pharmacists , HCPs who work in villages or pharmacies/drugstores , and who initially have low STI knowledge .

###25604761
BACKGROUND	Long-lasting insecticidal net screens ( LLIS ) fitted to domestic windows and doors in combination with targeted treatment ( TT ) of the most productive Aedes aegypti breeding sites were evaluated for their impact on dengue vector indices in a cluster-randomised trial in Mexico between 2011 and 2013 .
METHODS	Sequentially over 2 years , LLIS and TT were deployed in 10 treatment clusters ( 100 houses/cluster ) and followed up over 24 months .
METHODS	Cross-sectional surveys quantified infestations of adult mosquitoes , immature stages at baseline ( pre-intervention ) and in four post-intervention samples at 6-monthly intervals .
METHODS	Identical surveys were carried out in 10 control clusters that received no treatment .
RESULTS	LLIS clusters had significantly lower infestations compared to control clusters at 5 and 12 months after installation , as measured by adult ( male and female ) and pupal-based vector indices .
RESULTS	After addition of TT to the intervention houses in intervention clusters , indices remained significantly lower in the treated clusters until 18 ( immature and adult stage indices ) and 24 months ( adult indices only ) post-intervention .
CONCLUSIONS	These safe , simple affordable vector control tools were well-accepted by study participants and are potentially suitable in many regions at risk from dengue worldwide .

###24582007
OBJECTIVE	To compare remifentanil and morphine-midazolam for use in nonurgent endotracheal intubation in neonates .
METHODS	In this prospective noninferiority randomized trial , newborns of gestational age 28 weeks admitted in the neonatal intensive care unit requiring an elective or semielective endotracheal intubation were divided into 2 groups .
METHODS	One group ( n = 36 ) received remifentanil ( 1 g/kg ) , and the other group ( n = 35 ) received morphine ( 100 g/kg ) and midazolam ( 50 g/kg ) at a predefined time before intubation ( different in each group ) , to optimize the peak effect of each drug .
METHODS	Both groups also received atropine ( 20 g/kg ) .
METHODS	The primary outcome was to compare the conditions of intubation , and the secondary outcome was to compare the duration of successful intubation , physiological variables , and pain scores between groups for first and second intubation attempts .
METHODS	Adverse events and neurologic test data were reported .
RESULTS	Intubation with remifentanil was not inferior to that with morphine-midazolam .
RESULTS	At the first attempted intubation , intubation conditions were poor in 25 % of the remifentanil group and in 28.6 % of the morphine-midazolam group ( P = .471 ) .
RESULTS	For the second attempt , conditions were poor in 28.6 % of the remifentanil group , compared with 10 % of the morphine-midazolam group ( P = .360 ) .
RESULTS	The median time to successful intubation was 33 seconds ( IQR , 24-45 seconds ) for the remifentanil group versus 36 seconds ( IQR , 25-59 seconds ) for the morphine-medazolam group ( P = .359 ) at the first attempt and 45 seconds ( IQR , 35-64 seconds ) versus 56 seconds ( IQR , 44-68 seconds ) , respectively , for the second attempt ( P = .302 ) .
RESULTS	No significant between-group difference was reported for hypotension , bradycardia , or adverse events .
CONCLUSIONS	In our cohort , remifentanil was at least as effective as the morphine-midazolam regimen for endotracheal intubation .
CONCLUSIONS	Thus , premedication using this very-short-acting opioid can be considered in urgent intubations and is advantageous in rapid extubation .

###24738461
OBJECTIVE	To evaluate the efficacy and safety of the combination therapy of tamsulosin and solifenacin for mild and moderate benign prostatic hyperplasia ( BPH ) with overactive bladder ( OAB ) .
METHODS	We randomly divided 166 patients with BPH and concomitant OAB into a mild obstruction symptom group ( n = 88 ) and a moderate obstruction symptom group ( n = 78 ) , 48 of the former group treated with 0.2 mg tamsulosin + 5 mg solifenacin and the other 40 with 0.2 mg tamsulosin ; 36 of the latter group treated with 0.2 mg tamsulosin + 5 mg solifenacin and the other 42 with 0.2 mg tamsulosin , all administered once daily for 12 weeks .
METHODS	We obtained the International Prostate Symptom Score ( IPSS ) , urine storage period symptom score ( USPSS ) , voiding symptom score ( VSS ) , Qmax , residual urine volume , OAB symptom score ( OABSS ) and adverse reactions , and compared them among different
RESULTS	Among the patients with mild obstruction symptoms , the combination of tamsulosin and solifenacin achieved remark-groups .
RESULTS	able improvement in IPSS , USPSS , Qmax and OABSS as compared with the baseline ( P < 0.05 ) , but made no significant difference in the residual urine volume ( P > 0.05 ) , while tamsulosin improved IPSS only ( P < 0.05 ) .
RESULTS	The combination therapy exhibited an obvious superiority over tamsulosin alone in improving IPSS ( 9.7 micro 3.0 vs 15.8 micro 3.3 ) , USPSS ( 8.1 micro 1.7 vs 12.3 micro 3.1 ) , Qmax ( [ 18.6 micro 2.3 ] ml/s vs [ 14.2 micro 2.3 ] ml/s ) , and OABSS ( 5.3 micro 1.3 vs 9.7 micro 2.7 ) ( P < 0.05 ) , but there were no obvious differences in residual urine , urine routine test results and adverse events between the two therapies ( P > 0.05 ) .
RESULTS	In those with moderate obstruction symptoms , the combination therapy significantly improved IPSS , VSS , Qmax and OABSS ( P < 0.05 ) but not the residual urine ( P > 0.05 ) in comparison with the baseline .
RESULTS	The tamsulosin therapy achieved obvious improvement in IPSS , VSS , Qmax , OABSS and residual urine .
RESULTS	The combination therapy showed a better effect than tamsulosin only in OABSS ( 4.8 + / -1.5 vs 6.5 + / -2.5 , P < 0.05 ) , but no significant differences from the latter in IPSS , Qmax , VSS , routine urine test results , and adverse
CONCLUSIONS	Combination therapy of tamsulosin and solifenacin is obviously safe and efficacious in the treatment ( P > 0.05 ) .
CONCLUSIONS	eventsof bothmild and moderate BPH with concomitant OAB , and it is superior to tamsulosin alone .

###25557936
BACKGROUND	Circular excision by secondary-intention healing is useful for small skin defects ( diameter < 10 mm ) .
BACKGROUND	But the injection pain as the local anesthesia is administered one of the patients ' biggest concerns .
BACKGROUND	Buffered lidocaine can effectively relieve the injection pain , but it might increase the potential complications .
BACKGROUND	This study examined the effect of buffered lidocaine on wound healing .
METHODS	Patients undergoing circular excision by secondary-intention healing were divided into 2 groups and were administered buffered or unbuffered lidocaine as the local anesthesia .
METHODS	Comparative parameters included injection pain , postoperative pain , complication rate , scar width , and scar quality at 6 months .
METHODS	Statistical differences between the 2 agents were assessed .
RESULTS	The patients in the buffered group experienced 0.9 fewer scaled injection pain units than did the patients in the unbuffered group ( p = 0.009 ) .
RESULTS	Complication rates and scar appearance did not show any statistical difference between the 2 groups .
CONCLUSIONS	Buffered lidocaine is useful to relieve the injection pain during the secondary-intention healing , and it is safe to use if it is applied properly .

###25485802
BACKGROUND	Different techniques have been used for filler injection of the tear trough and palpebromalar groove .
BACKGROUND	Most patients report good results ; however , some patients here experienced variable degrees of side effects .
OBJECTIVE	To assess if previous estimation of the bony orbit depth could affect the choice between bolus and serial puncture technique , and thereby the procedure outcome .
METHODS	In 32 patients , the periosteum depth was measured by using a 28 G needle at 2 points : Point A at the midpupillary line and Point B at the outer canthus .
METHODS	The bolus technique was performed in the right side , and serial puncture technique was done on the left side .
RESULTS	There was a significant difference in the degree of improvement between both sides in 71 % of patients : 40 % had better improvement on the right side , whereas 31 % had better improvement on the left side .
RESULTS	Cases with skin-to-periosteum depth less than 0.5 cm showed better results with serial puncture technique , whereas those with more than 0.5 cm depth showed better results with bolus technique .
CONCLUSIONS	Assessment of bony orbit depth could offer new tool for selecting infraorbital groove injection technique .

###24509190
OBJECTIVE	A randomized controlled trial to confirm the non-inferiority of laparoscopic surgery to open surgery in terms of overall survival was conducted , and short-term surgical outcomes are demonstrated .
BACKGROUND	The efficacy and safety outcome of laparoscopic surgery for clinical stages II/III colon cancer undergoing Japanese D3 dissection are still unclear .
METHODS	Eligibility criteria included colon cancer ; tumor located in the cecum , ascending , sigmoid , or rectosigmoid colon ; T3 or T4 without involvement of other organs ; N0-2 ; and M0 .
METHODS	Patients were randomized preoperatively and underwent tumor resection with D3 dissection .
METHODS	Safety analyses were conducted by per-protocol set .
RESULTS	A total of 1057 patients were randomized between October 2004 and March 2009 .
RESULTS	By per-protocol set , 524 patients who underwent open surgery and 533 patients who underwent laparoscopic surgery were analyzed .
RESULTS	D3 dissection was performed in 521 ( 99.4 % ) patients in the open surgery arm and 529 ( 99.2 % ) patients in the laparoscopic surgery arm .
RESULTS	Conversion to open surgery was needed for 29 ( 5.4 % ) patients .
RESULTS	Patients assigned to laparoscopic surgery had less blood loss ( P < 0.001 ) , although laparoscopic surgery lasted 52 minutes longer ( P < 0.001 ) .
RESULTS	Laparoscopic surgery was associated with a shorter time to pass first flatus , decreased use of analgesics after 5 postoperative days , and a shorter hospital stay .
RESULTS	Morbidity [ 14.3 % ( 76/533 ) vs 22.3 % ( 117/524 ) , P < 0.001 ] was lower in the laparoscopic surgery arm .
CONCLUSIONS	Short-term surgical safety and clinical benefits of laparoscopic D3 dissection were demonstrated .
CONCLUSIONS	The primary endpoint will be reported after the primary analysis , planned for 2014 .

###24343353
OBJECTIVE	The objective of this study is to understand the effectiveness of foam rolling ( FR ) as a recovery tool after exercise-induced muscle damage , analyzing thigh girth , muscle soreness , range of motion ( ROM ) , evoked and voluntary contractile properties , vertical jump , perceived pain while FR , and force placed on the foam roller .
METHODS	Twenty male subjects ( 3 yr of strength training experience ) were randomly assigned into the control ( n = 10 ) or FR ( n = 10 ) group .
METHODS	All the subjects followed the same testing protocol .
METHODS	The subjects participated in five testing sessions : 1 ) orientation and one-repetition maximum back squat , 2 ) pretest measurements , 10 10 squat protocol , and POST-0 ( posttest 0 ) measurements , along with measurements at 3 ) POST-24 , 4 ) POST-48 , and 5 ) POST-72 .
METHODS	The only between-group difference was that the FR group performed a 20-min FR exercise protocol at the end of each testing session ( POST-0 , POST-24 , and POST-48 ) .
RESULTS	FR substantially reduced muscle soreness at all time points while substantially improving ROM .
RESULTS	FR negatively affected evoked contractile properties with the exception of half relaxation time and electromechanical delay ( EMD ) , with FR substantially improving EMD .
RESULTS	Voluntary contractile properties showed no substantial between-group differences for all measurements besides voluntary muscle activation and vertical jump , with FR substantially improving muscle activation at all time points and vertical jump at POST-48 .
RESULTS	When performing the five FR exercises , measurements of the subjects ' force placed on the foam roller and perceived pain while FR ranged between 26 and 46 kg ( 32 % -55 % body weight ) and 2.5 and 7.5 points , respectively .
CONCLUSIONS	The most important findings of the present study were that FR was beneficial in attenuating muscle soreness while improving vertical jump height , muscle activation , and passive and dynamic ROM in comparison with control .
CONCLUSIONS	FR negatively affected several evoked contractile properties of the muscle , except for half relaxation time and EMD , indicating that FR benefits are primarily accrued through neural responses and connective tissue .

###25575764
OBJECTIVE	Biochemical modulation of 5-fluorouracil ( 5-FU ) by leucovorin ( LV ) enhances antitumor activity .
OBJECTIVE	LV is thus often added to 5-FU-based regimens for the treatment of metastatic colorectal cancer ( mCRC ) .
OBJECTIVE	A combination of S-1 , oxaliplatin , and LV ( SOL ) was shown to be feasible , effective , and safe in a previous phase I trial .
OBJECTIVE	We therefore conducted a randomized phase II trial to evaluate efficacy and safety of SOL compared with mFOLFOX6 .
METHODS	Patients with mCRC and no prior chemotherapy were randomly assigned to receive either SOL or mFOLFOX6 .
METHODS	SOL consisted of S-1 ( 40-60mg bid ) plus oral LV ( 25mg bid ) for 1week and oxaliplatin ( 85mg/m ( 2 ) ) on day 1 , repeated every 2weeks .
RESULTS	Among 107 patients enrolled from July 2008 through July 2009 , 105 ( 56 in the SOL group and 49 in the mFOLFOX6 group ) were eligible and evaluated .
RESULTS	The median progression-free survival was 9.6 months in the SOL group and 6.9 months in the mFOLFOX6 group [ hazard ratio ( HR ) 0.83 , 95 % confidence interval ( CI ) 0.49-1 .40 ] .
RESULTS	The median overall survival was 29.9 and 25.9 months , respectively ( HR 0.91 , 95 % CI 0.55-1 .49 ) .
RESULTS	The response rate was 55 % in both groups .
RESULTS	Grade 3 or 4 adverse drug reactions were neutropenia ( 20 % with SOL vs 41 % with mFOLFOX6 ) , sensory neuropathy ( 20 vs 2.0 % ) , anorexia ( 13 vs 7.8 % ) , fatigue ( 11 vs 5.9 % ) , and diarrhea ( 11 vs 3.9 % ) .
CONCLUSIONS	SOL demonstrated promising efficacy and acceptable toxicity as first-line chemotherapy for mCRC .
CONCLUSIONS	Further studies of SOL combined with molecular target agents are warranted .

###25391539
OBJECTIVE	To test the hypothesis that the GH receptor ( GHR ) exon 3 deleted ( d3 ) / full-length ( fl ) polymorphism influences anthropometry and body composition in the general population .
METHODS	The Swedish Obese Subjects ( SOS ) reference study is a cross-sectional population-based study , randomly selected from a population registry .
METHODS	A subgroup of the population-based Malm Diet and Cancer study ( MDC-CC ) was used as a replication cohort .
METHODS	The SOS reference study comprises 1135 subjects ( 46.2 % men ) , with an average age of 49.5 years .
METHODS	The MDC-CC includes 5451 successfully genotyped subjects ( 41.5 % men ) , with an average age of 57.5 years .
METHODS	GHR d3/fl genotypes were determined using TagSNP rs6873545 .
METHODS	Linear regression analyses were used to test for genotype-phenotype associations .
RESULTS	In the SOS reference study , subjects homozygous for the d3-GHR weighed 4kg more ( P = 0.011 ) , and had larger waist-to-hip ratio ( WHR , P = 0.036 ) , larger waist circumference ( P = 0.016 ) , and more fat-free mass estimated from total body potassium ( P = 0.026 ) than grouped fl/d3 and fl/fl subjects ( d3-recessive genetic model ) .
RESULTS	The association with WHR was replicated in the MDC-CC ( P = 0.002 ) , but not those with other anthropometric traits .
CONCLUSIONS	In this population-based study , the GHR d3/fl polymorphism was found to be of functional relevance and associated with central adiposity , such that subjects homozygous for the d3-GHR showed an increased abdominal obesity .

###26299215
BACKGROUND	Appropriate use criteria ( AUC ) for transthoracic echocardiography ( TTE ) were developed to address concerns regarding inappropriate use of TTE .
BACKGROUND	A previous pilot study suggests that an educational and feedback intervention can reduce inappropriate TTEs ordered by physicians in training .
BACKGROUND	It is unknown if this type of intervention will be effective when targeted at attending level physicians in a variety of clinical settings .
OBJECTIVE	The aim of this international , multicenter study is to evaluate the hypothesis that an AUC-based educational and feedback intervention will reduce the proportion of inappropriate echocardiograms ordered by attending physicians in the ambulatory environment .
METHODS	In an ongoing multicentered , investigator-blinded , randomized controlled trial across Canada and the United States , cardiologists and primary care physicians practicing in the ambulatory setting will be enrolled .
METHODS	The intervention arm will receive ( 1 ) a lecture outlining the AUC and most recent available evidence highlighting appropriate use of TTE , ( 2 ) access to the American Society of Echocardiography mobile phone app , and ( 3 ) individualized feedback reports e-mailed monthly summarizing TTE ordering behavior including information on inappropriate TTEs and brief explanations of the inappropriate designation .
METHODS	The control group will receive no education on TTE appropriate use and order TTEs as usual practice .
CONCLUSIONS	The Echo WISELY ( Will Inappropriate Scenarios for Echocardiography Lessen Significantly in an education RCT ) study is the first multicenter randomized trial of an AUC-based educational intervention .
CONCLUSIONS	The study will examine whether an education and feedback intervention will reduce the rate of outpatient inappropriate TTEs ordered by attending level cardiologists and primary care physicians ( www.clinicaltrials.gov identifier NCT02038101 ) .

###24957311
BACKGROUND	Poststroke cognitive impairment is common and identification of prognostic factors associated with it and its relationship with other functional outcomes may help in developing preventative strategies .
METHODS	Previously independent patients with acute stroke , enrolled into the ongoing `` Efficacy of Nitric Oxide in Stroke '' trial , were assessed by telephone on day 90 for cognitive impairment using modified versions of `` Mini Mental State Examination '' ( MMSE-M ) and `` Telephone Instrument for Cognitive Status '' ( TICS-M ) scales and category fluency .
METHODS	The relationship of cognitive impairment with baseline prognostic factors and other functional outcomes at day 90 were studied .
RESULTS	The analysis included 1572 patients , mean age 69years ( standard deviation , 12 ) , and female 40 % .
RESULTS	By 90days , 246 patients had died , and cognitive impairment was present in 38 % .
RESULTS	Increasing age , stroke severity , heart rate , and presence of cerebral atrophy on baseline neuroimaging were associated with cognitive impairment ( all P < .001 ) .
RESULTS	Hypertension and atrial fibrillation were also associated with category fluency and MMSE-M , respectively .
RESULTS	Cognition was significantly related to other functional outcomes , TICS-M with dependency ( modified Rankin Scale , rs = -.562 , P < .001 ) ; disability ( Barthel Index , rs = .577 , P < .001 ) ; mood ( Zung Depression Score , rs = -.542 , P < .001 ) ; and quality of life ( Euro Quality of life-5 Descriptor , rs = .519 , P < .001 ) .
CONCLUSIONS	In previouslyindependent individuals , cognitive impairment was common 3months after stroke and related to increasing age , stroke severity , hypertension , atrial fibrillation , and cerebral atrophy on brain scanning .
CONCLUSIONS	Cognition was related to dependency , disability , low mood , and quality of life .
CONCLUSIONS	Hence , treatment directed toward reducing dependency might also reduce cognitive impairment .

###24456998
BACKGROUND	Diabetes , a highly prevalent , chronic disease , is associated with increasing frailty and functional decline in older people , with concomitant personal , social , and public health implications .
BACKGROUND	We describe the rationale and methods of the multi-modal intervention in diabetes in frailty ( MID-Frail ) study .
METHODS	The MID-Frail study is an open , randomised , multicentre study , with random allocation by clusters ( each trial site ) to a usual care group or an intervention group .
METHODS	A total of 1,718 subjects will be randomised with each site enrolling on average 14 or 15 subjects .
METHODS	The primary objective of the study is to evaluate , in comparison with usual clinical practice , the effectiveness of a multi-modal intervention ( specific clinical targets , education , diet , and resistance training exercise ) in frail and pre-frail subjects aged 70years with type 2 diabetes in terms of the difference in function 2 years post-randomisation .
METHODS	Difference in function will be measured by changes in a summary ordinal score on the short physical performance battery ( SPPB ) of at least one point .
METHODS	Secondary outcomes include daily activities , economic evaluation , and quality of life .
CONCLUSIONS	The MID-Frail study will provide evidence on the clinical , functional , social , and economic impact of a multi-modal approach in frail and pre-frail older people with type 2 diabetes .
BACKGROUND	ClinicalTrials.gov : NCT01654341 .

###25315960
OBJECTIVE	We devised a 1-step posterior reconstruction technique that opposes the median dorsal raphe only to the posterior counterpart of the detrusor apron rather than to Denonvilliers ' fascia .
OBJECTIVE	In a retrospective study we previously found that during robot-assisted laparoscopic prostatectomy this new technique could significantly shorten continence recovery time .
OBJECTIVE	We designed a prospective clinical trial to confirm this .
METHODS	We designed a single-blind , parallel group , randomized , controlled trial .
METHODS	A total of 100 men who underwent robot-assisted laparoscopic prostatectomy performed by a single surgeon at a referral center were randomly allocated to the intervention group ( 50 ) or the control group ( 50 ) from October 2012 through August 2013 .
METHODS	The intervention group underwent posterior reconstruction with this new technique before vesicourethral anastomosis .
METHODS	All patients in each group were treated with anterior reconstruction .
METHODS	The study primary end point was time to continence recovery , defined as no pad use .
METHODS	Secondary outcomes were time to recovery of social continence , defined as 0 or 1 pad used per day .
RESULTS	One control was excluded from analysis due to open conversion and 4 patients were excluded since they withdrew from participation .
RESULTS	Median time to complete continence recovery did not differ significantly between the intervention and control groups ( 106 and 119 days , respectively , p = 0.890 ) .
RESULTS	However , time to social continence recovery was significantly shorter in the intervention group than in controls ( median 18 vs 30 days , p = 0.024 ) .
CONCLUSIONS	One-step posterior reconstruction did not significantly shorten time to complete continence recovery .
CONCLUSIONS	However , it seemed to have a marginal benefit on early recovery of social continence .

###26142600
OBJECTIVE	To assess ( 1 ) plasma levels of antidiuretic hormone ( ADH ) and brain natriuretic peptide ( BNP ) and urinary levels of electrolytes in children with sleep disordered breathing ( SDB ) , with or without nocturnal enuresis ( NE ) , and ( 2 ) the effect of adenotonsillectomy ( T&A ) on urinary electrolytes and the secretion of ADH and BNP in children with NE and SDB .
OBJECTIVE	We previously reported post-T & A improvements in plasma levels of BNP and ADH in children with SDB and NE .
OBJECTIVE	However , the differences in plasma concentration of these hormones in SDB children with and without NE , and their relationships with urinary electrolytes , have not yet been addressed .
METHODS	This prospective study compared concentrations of urinary electrolytes and plasma ADH and BNP in ( 1 ) children with SDB and NE ( study group ) and an age - and sex-matched control group of children with SDB without NE , and ( 2 ) the study group before and 1-month after T&A .
RESULTS	Compared with the control group ( n = 31 ) , the study group ( n = 37 ) exhibited significantly lower ADH ( P = .04 ) and higher BNP ( P = .009 ) plasma levels .
RESULTS	The differences in urinary electrolytes were not significant .
RESULTS	Post-T & A , the study group showed significantly decreased BNP ( P = .018 ) , urinary sodium-to-creatinine ratio ( P = .02 ) , and urinary calcium-to-creatinine ratio ( P = .007 ) compared with the pre-T & A values .
RESULTS	Post-T & A changes in urinary calcium were significantly correlated with changes in sodium excretion ( P = .002 ) and in plasma levels of BNP ( P < .001 ) .
CONCLUSIONS	The presence of NE is associated with altered ADH and BNP levels in children with SDB .
CONCLUSIONS	T&A led to normalization of ADH and BNP , probably through a calcium - and sodium-dependent mechanism .

###24811228
OBJECTIVE	We compared intra-procedural neonatal pain , agitation and sedation scale ( N-PASS ) scores between a novel ` continuous arteriovenous exchange ' ( CAVE ) and conventional pull-push ( PP ) techniques of partial exchange transfusion ( PET ) among neonates with polycythemia .
METHODS	Neonates > 32-0/7 weeks gestation , requiring PET for polycythemia , were randomized to PP or CAVE techniques .
METHODS	The procedure was video-recorded and edited to mask the technique .
METHODS	Intra-procedural N-PASS scores assigned by two trained and masked neonatal fellows were compared .
RESULTS	Twenty-two neonates were randomized to CAVE ( n = 12 ) or PP ( n = 10 ) method .
RESULTS	The area under curve for cumulative N-PASS scores was significantly lesser in CAVE group ( mean difference-11 .9 ( 95 % CI = -4.2 , -19.6 ) , P = 0.005 ) ) .
RESULTS	Decrease in hematocrit and complications of PET were comparable .
RESULTS	Time for PET was longer with CAVE technique ( 16 ( 9 , 29 ) min vs 10 ( 6 , 12 ) min , P = 0.016 ) .
CONCLUSIONS	CAVE technique of PET was associated with lesser procedure-related pain ( N-PASS scores ) as compared with PP technique among neonates > 32 weeks gestation .

###24921948
BACKGROUND	Multicomponent school-based interventions have the potential to reduce the age-related decline in adolescents ' physical activity ( PA ) , yet there is not consistent evidence to guide non-curricular and school environment interventions .
BACKGROUND	The aim of this study was to assess the effectiveness of a multicomponent environmental school-based intervention , designed to reduce the age-related decline in PA among adolescents .
METHODS	A cluster randomized controlled trial was conducted with 7 intervention and 7 control schools .
METHODS	Baseline measurements were carried out in spring 2010 with 2 years of follow-up .
METHODS	A total of 1,348 students ( 11-13 years , in grade 5 and 6 ) enrolled in the study at baseline .
METHODS	The 14 schools included in the study were located in the Region of Southern Denmark .
METHODS	The intervention consisted of organizational and physical changes in the school environment with a total of 11 intervention components .
METHODS	The primary outcome measure was overall PA ( cpm , counts per minute ) and was supported by analyses of time spent in MVPA , and time spent sedentary .
METHODS	Furthermore , a secondary outcome measure was PA in school time and during recess .
METHODS	PA was measured using accelerometer ( Actigraph GT3X ) .
RESULTS	A total of 797 students completed the trial and had valid accelerometer data .
RESULTS	No significant difference was found for overall PA with an adjusted difference of -19.1 cpm ( 95 % CI : -93 , 53 ) or for school time activity with an adjusted difference of 6 cpm ( 95 % CI : -73 , 85 ) .
RESULTS	A sensitivity analysis revealed a positive significant intervention effect of PA in recess with an adjusted difference of 95 cpm .
CONCLUSIONS	No evidence was found of the overall effect of a non-curricular multicomponent school-based intervention on PA among Danish adolescents .
CONCLUSIONS	The intervention was positively associated with PA during school time and recess , however , with small estimates .
CONCLUSIONS	Lack of effect on overall PA could be due to both program theory and different degrees of implementation .
BACKGROUND	www.Controlled-Trials.com ISRCTN79122411 .

###24777164
METHODS	Randomized , controlled clinical trial .
OBJECTIVE	Bladder and bowel management may cause serious autonomic dysreflexia ( AD ) in subjects with high spinal cord injury ( SCI ) .
OBJECTIVE	We aimed at investigating autonomic responses to digital rectal evacuation ( DE ) , transanal irrigation ( TAI ) with 500ml and filling cystometry ( FC ) in SCI .
METHODS	Aarhus University Hospital , Denmark .
METHODS	Eight subjects with SCI ( AIS A ) at or above T6 ( high SCI ) and a previous history of AD were compared with three subjects with SCI ( AIS A ) between T10 and L2 ( low SCI ) .
METHODS	In randomized order , DE , TAI and FC were performed .
METHODS	AD was defined as an acute rise in systolic blood pressure ( sBP ) of 30mmHg above baseline .
METHODS	Blood levels of norepinephrine and epinephrine were determined before and shortly after the procedures .
RESULTS	During all three procedures , AD occurred in all patients with high SCI but not in those with low SCI .
RESULTS	In high SCI subjects , DE increased median sBP from 127 ( range : 86-154 ) to 188 ( range : 140-206 ) mmHg ( P < 0.02 ) , TAI from 126 ( range : 91-146 ) to 163 ( range : 130-188 ) mmHg ( P < 0.02 ) and FC from 125 ( range : 106-149 ) to 200 ( range : 179-220 ) mmHg ( P < 0.01 ) .
RESULTS	The sBP increase was lower during TAI than during DE ( P < 0.05 ) or FC ( P < 0.02 ) .
RESULTS	In high SCI subjects , the blood levels of norepinephrine , but not those of epinephrine , increased significantly during all three stimuli ( all P < 0.05 ) .
CONCLUSIONS	Bowel and bladder management caused AD in high SCI .
CONCLUSIONS	The response is less severe during TAI than during FC or DE .

###24533878
BACKGROUND	In high-resource settings , obstetric ultrasound is a standard component of prenatal care used to identify pregnancy complications and to establish an accurate gestational age in order to improve obstetric care .
BACKGROUND	Whether or not ultrasound use will improve care and ultimately pregnancy outcomes in low-resource settings is unknown .
METHODS	This multi-country cluster randomized trial will assess the impact of antenatal ultrasound screening performed by health care staff on a composite outcome consisting of maternal mortality and maternal near-miss , stillbirth and neonatal mortality in low-resource community settings .
METHODS	The trial will utilize an existing research infrastructure , the Global Network for Women 's and Children 's Health Research with sites in Pakistan , Kenya , Zambia , Democratic Republic of Congo and Guatemala .
METHODS	A maternal and newborn health registry in defined geographic areas which documents all pregnancies and their outcomes to 6 weeks post-delivery will provide population-based rates of maternal mortality and morbidity , stillbirth , neonatal mortality and morbidity , and health care utilization for study clusters .
METHODS	A total of 58 study clusters each with a health center and about 500 births per year will be randomized ( 29 intervention and 29 control ) .
METHODS	The intervention includes training of health workers ( e.g. , nurses , midwives , clinical officers ) to perform ultrasound examinations during antenatal care , generally at 18-22 and at 32-36 weeks for each subject .
METHODS	Women who are identified as having a complication of pregnancy will be referred to a hospital for appropriate care .
METHODS	Finally , the intervention includes community sensitization activities to inform women and their families of the availability of ultrasound at the antenatal care clinic and training in emergency obstetric and neonatal care at referral facilities .
CONCLUSIONS	In summary , our trial will evaluate whether introduction of ultrasound during antenatal care improves pregnancy outcomes in rural , low-resource settings .
CONCLUSIONS	The intervention includes training for ultrasound-nave providers in basic obstetric ultrasonography and then enabling these trainees to use ultrasound to screen for pregnancy complications in primary antenatal care clinics and to refer appropriately .
BACKGROUND	Clinicaltrials.gov ( NCT # 01990625 ) .

###24411809
OBJECTIVE	Substance use and childhood maltreatment experience are linked , but little is known about the association with polydrug use patterns .
METHODS	Latent class analyses ( LCA ) were performed on eight illicit drugs in a random population sample of young Danes separated by sex ( males : n = 1,555 ; females : n = 1,425 ) .
METHODS	Logistic regressions explored associations of polydrug use patterns and childhood maltreatment .
RESULTS	A three-class solution best described patterns of polydrug use in both the male and female samples .
RESULTS	Across all LCA models , Class 1 was characterized by individuals who represented wide-range polydrug users , endorsing many of the drug types ( males = 8 % ; females = 2 % ) .
RESULTS	Class 2 was characterized by amphetamine , cannabis , cocaine , and amyl nitrate users ( males = 18 % ; females = 7 % ) .
RESULTS	Class 3 was characterized by individuals who endorsed either low-level use of cannabis only or no drug use ( males = 74 % ; females = 91 % ) .
RESULTS	For males , having been a child-protection case was associated with Classes 1 and 2 and for females with Class 2 , compared with Class 3 .
RESULTS	Alcohol problems were associated with Classes 1 and 2 for both sexes .
RESULTS	Sexual abuse was associated with Classes 1 and 2 for females but not males , whereas physical abuse was associated with Classes 1 and 2 for males but not females , as compared with Class 3 .
CONCLUSIONS	Separate sex analyses are important ; although patterns of polydrug use are broadly similar , females are less frequently polydrug users .
CONCLUSIONS	In addition , different relationships exist for the sexes , such that polydrug use patterns are associated with sexual abuse in females , whereas such patterns are associated with physical abuse in young males .

###24909628
BACKGROUND	Recombinant human bone morphogenetic protein ( rhBMP ) -2 has been used in some craniofacial centers worldwide .
BACKGROUND	However , its influence on nasal morphology is unknown .
BACKGROUND	Thus , the objective of this investigation was to assess the effect of maxillary alveolar reconstruction on nasal position and symmetry in unilateral complete cleft lip patients who underwent traditional iliac crest bone grafting transferring versus reconstruction using rhBMP-2 .
METHODS	Nineteen unilateral complete cleft lip patients were randomly divided into two groups .
METHODS	In group 1 , patients underwent traditional iliac crest bone grafting transferring ( n = 11 ) and in group 2 , patients underwent alveolar reconstruction using collagen matrix with lyophilized rhBMP-2 ( n = 8 ) .
METHODS	Computerized tomography ( CT ) imaging was performed preoperatively and at 6 months postoperatively using a previously standardized protocol .
METHODS	Linear distances using anatomic landmarks were performed using tridimensional CT data reformatted by the OsiriX ( ) software .
METHODS	Quantitative and qualitative measurements to assess intra - and inter-group nasal position modifications were performed .
RESULTS	Intra-group pre - and postoperative comparisons showed significant differences ( p < 0.05 ) in two linear measurements of group 1 , while group 2 did not present a difference ( p > 0.05 ) .
RESULTS	Group 2 presented significant postoperative enhancement ( p < 0.05 ) in the quantitative nasal symmetry in one measurement .
RESULTS	Qualitative analysis showed postoperative nasal symmetry enhancement in 75 % of the measurements of group 2 and 36 % of group 1 .
RESULTS	There was no statistically significant difference in the inter-group comparisons .
CONCLUSIONS	Our study demonstrated that both groups showed similar effect on nasal symmetry .

###25371578
BACKGROUND	Connective Tissue Massage ( CTM ) or Manipulation is a bodywork technique which lies at the interface between alternative approaches .
BACKGROUND	The autonomic balancing responses to CTM can be useful in the treatment of anxiety .
OBJECTIVE	This study was planned to investigate the effects of connective tissue mobilization ( CTM ) on quality of life and emotional status in healthy subjects .
OBJECTIVE	Design ; Prospective trial , Setting ; Treatment and Population .
OBJECTIVE	The study was conducted on 100 volunteers ( students ) .
OBJECTIVE	Students in second class were in CTM group ( 20,491,37 years ) and students ( 19,501,15 years ) educating in class 1 were in control group .
METHODS	Participants were assessed before and after CTM according to flexibility of trunk flexion , hamstring muscles , trunk hyperextension and lateral flexion .
METHODS	It was used The SF-36 Health-Related Quality of Life Inventory ( SF-36 ) to assess general health status and Beck Depression Scale was used for assessing emotional status .
RESULTS	It was observed a significant increase at lateral flexion to the right of trunk ( p = 0,03 ) in CTM group after application .
RESULTS	It was found a significant difference ( p = 0,009 ) in emotional status between groups .
RESULTS	It was found differences at general health level ( p = 0,001 ) , limitations in emotional role ( p = 0,016 ) in SF-36 .
RESULTS	It was some differences in depression status and some subscales of SF-36 ( general health , social status , emotional well-being , pain and energy levels ) in favour of control group before application .
RESULTS	It was no difference between groups after application .
CONCLUSIONS	CTM could be used for minimizing depressive symptoms , improving quality of life in healthy young subjects .

###24265734
BACKGROUND	Occupational sedentary behaviour is an important contributor to overall sedentary risk .
BACKGROUND	There is limited evidence for effective workplace interventions to reduce occupational sedentary time and increase light activity during work hours .
BACKGROUND	The purpose of the study was to determine if participatory workplace interventions could reduce total sedentary time , sustained sedentary time ( bouts > 30 minutes ) , increase the frequency of breaks in sedentary time and promote light intensity activity and moderate/vigorous activity ( MVPA ) during work hours .
METHODS	A randomised controlled trial ( ANZCTR NUMBER : ACTN12612000743864 ) was conducted using clerical , call centre and data processing workers ( n = 62 , aged 25-59 years ) in 3 large government organisations in Perth , Australia .
METHODS	Three groups developed interventions with a participatory approach : ` Active office ' ( n = 19 ) , ` Active Workstation ' and promotion of incidental office activity ; ` Traditional physical activity ' ( n = 14 ) , pedometer challenge to increase activity between productive work time and ` Office ergonomics ' ( n = 29 ) , computer workstation design and breaking up computer tasks .
METHODS	Accelerometer ( ActiGraph GT3X , 7 days ) determined sedentary time , sustained sedentary time , breaks in sedentary time , light intensity activity and MVPA on work days and during work hours were measured before and following a 12 week intervention period .
RESULTS	For all participants there was a significant reduction in sedentary time on work days ( -1.6 % , p = 0.006 ) and during work hours ( -1.7 % , p = 0.014 ) and a significant increase in number of breaks/sedentary hour on work days ( 0.64 , p = 0.005 ) and during work hours ( 0.72 , p = 0.015 ) ; there was a concurrent significant increase in light activity during work hours ( 1.5 % , p = 0.012 ) and MVPA on work days ( 0.6 % , p = 0.012 ) .
CONCLUSIONS	This study explored novel ways to modify work practices to reduce occupational sedentary behaviour .
CONCLUSIONS	Participatory workplace interventions can reduce sedentary time , increase the frequency of breaks and improve light activity and MVPA of office workers by using a variety of interventions .
BACKGROUND	Australian New Zealand Clinical Trials Registry ACTN12612000743864 .

###26267984
OBJECTIVE	To study postoperative pain relief in major gynaecological surgery by perioperative parecoxib administration in Thammasat University Hospital .
METHODS	This double-blind randomized controlled clinical trial was conducted in Thammasat University Hospital , Pathumthani , Thailand from October 2013 to May 2014 .
METHODS	One hundred and twenty patients who underwent elective gynaecological surgery were randomized assigned to study and control groups .
METHODS	Study group ( n = 60 ) received 40 mg parecoxib and control group ( n = 60 ) received placebo at 1 hour before surgery .
METHODS	The postoperative visual analog scale ( VAS ) at 3 , 6 , 12 and 24 hours , frequency of meperidine consumption in 24 hours and side effects of parecoxib were recorded .
RESULTS	VAS of study group after operation at 3 , 6 , 12 and 24 hours was significantly lower than control group .
RESULTS	Meperidine consumption in placebo group was significantly higher than study group ( 27.50 19.36 and 48.75 28.15 mg , respectively ; p < 0.001 ) .
RESULTS	There was no side effect from parecoxib in this study .
CONCLUSIONS	Intravenous postoperativeparecoxib injection could relief pain and reduced meperidine consumption .
CONCLUSIONS	Parecoxib could be safely used in gynaecological surgery for postoperative pain relief

###24910161
BACKGROUND	Efficacy of burping in lowering colic and regurgitation episodes in healthy term babies lacks evidence in literature .
METHODS	We conducted a randomized controlled trial to compare efficacy of burping versus no-burping in 71 mother-baby dyads in community setting .
METHODS	Primary outcome was reduction in event rates of colic and regurgitation episodes over 3 months .
RESULTS	Baseline characteristics were similar in two groups .
RESULTS	Difference in incidence rates of colic between the control and burping group was 1.57 episodes/infant/100 weeks [ 95 % confidence interval ( CI ) : -0.63 to 3.76 ] .
RESULTS	There was statistically no significant reduction in colic episodes between burping and non-burping study subjects during 3 months of follow-up ( adjusted relative risk 0.64 ; 95 % CI : 0.22-1 .86 , P-value 0.41 ) .
RESULTS	Incidence rate difference of regurgitation episodes/infant/week between burping and control group was 4.36 ( 95 % CI : 4.04 to 4.69 ) and there was statistically significant increase in burping group ( adjusted relative risk 2.05 ; 95 % CI : 1.92-2 .18 , P-value < 0.0001 ) .
CONCLUSIONS	Although burping is a rite of passage , our study showed that burping did not significantly lower colic events and there was significant increase in regurgitation episodes in healthy term infants up to 3 months of follow-up .

###25565495
OBJECTIVE	To test a novel social network HIV risk-reduction intervention for MSM in Russia and Hungary , where same-sex behavior is stigmatized and men may best be reached through their social network connections .
METHODS	A two-arm trial with 18 sociocentric networks of MSM randomized to the social network intervention or standard HIV/STD testing/counseling .
METHODS	St. Petersburg , Russia and Budapest , Hungary .
METHODS	Eighteen ` seeds ' from community venues invited the participation of their MSM friends who , in turn , invited their own MSM friends into the study , a process that continued outward until eighteen three-ring sociocentric networks ( mean size = 35 members , n = 626 ) were recruited .
METHODS	Empirically identified network leaders were trained and guided to convey HIV prevention advice to other network members .
METHODS	Changes in sexual behavior from baseline to 3-month and 12-month follow-up , with composite HIV/STD incidence , measured at 12 months to corroborate behavior changes .
RESULTS	There were significant reductions between baseline , first follow-up , and second follow-up in the intervention versus comparison arm for proportion of men engaging in any unprotected anal intercourse ( UAI ) ( P = 0.04 ) ; UAI with a nonmain partner ( P = 0.04 ) ; and UAI with multiple partners ( P = 0.002 ) .
RESULTS	The mean percentage of unprotected anal intercourse acts significantly declined ( P = 0.001 ) , as well as the mean number of UAI acts among men who initially had multiple partners ( P = 0.05 ) .
RESULTS	Biological HIV/STD incidence was 15 % in comparison condition networks and 9 % in intervention condition networks .
CONCLUSIONS	Even where same-sex behavior is stigmatized , it is possible to reach MSM and deliver HIV prevention through their social networks .

###25638438
OBJECTIVE	Children 's nighttime fears are a normal part of child development and are transient for most children , but result in considerable distress for others .
OBJECTIVE	The present study evaluated a 4-week bibliotherapy intervention designed to treat young children with persistent and interfering nighttime fears utilizing a multiple baseline design .
METHODS	Nine children between 5 and 7 years of age with specific phobia diagnoses were randomized into one of three baseline control conditions ( 1 , 2 , or 3 weeks ) .
METHODS	The treatment protocol involved parents reading Uncle Lightfoot , Flip that Switch : Overcoming Fear of the Dark , Academic Version ( Coffman , 2012 ) with their children over 4 weeks while engaging in activities prescribed in the book .
METHODS	Assessments took place at baseline , post treatment , and 1 month following treatment .
METHODS	Daily and weekly tracking of nighttime behaviors was also obtained .
RESULTS	Pre-post group analyses revealed that eight of the nine children demonstrated clinically significant change in anxiety severity .
RESULTS	In addition , decreases in child-reported nighttime fears were observed , as were parent-reported decreases in separation anxiety and increases in the number of nights children slept in their own bed .
CONCLUSIONS	The present study provides initial support for the use of bibliotherapy in the treatment of nighttime fears .
CONCLUSIONS	Further replication and evaluation are needed to determine appropriate length of treatment and long-term effects .
CONCLUSIONS	Implications of the findings are discussed .

###25881589
BACKGROUND	Helicobacter pylori ( H. pylori ) frequently colonizes the stomach .
BACKGROUND	Gastroesophageal reflux disease ( GERD ) is a common and costly disease .
BACKGROUND	But the relationship of H. pylori and GERD is still unclear .
BACKGROUND	This study aimed to explore the effect of H. pylori and its eradication on reflux esophagitis therapy .
METHODS	Patients diagnosed with reflux esophagitis by endoscopy were enrolled ; based on rapid urease test and Warth-Starry stain , they were divided into H. pylori positive and negative groups .
METHODS	H. pylori positive patients were randomly given H. pylori eradication treatment for 10 days , then esomeprazole 20 mg bid for 46 days .
METHODS	The other patients received esomeprazole 20 mg bid therapy for 8 weeks .
METHODS	After treatment , three patient groups were obtained : H. pylori positive eradicated , H. pylori positive uneradicated , and H. pylori negative .
METHODS	Before and after therapy , reflux symptoms were scored and compared .
METHODS	Healing rates were compared among groups .
METHODS	The 2 test and t-test were used , respectively , for enumeration and measurement data .
RESULTS	There were 176 H. pylori positive ( with 92 eradication cases ) and 180 negative cases .
RESULTS	Healing rates in the H. pylori positive eradicated and H. pylori positive uneradicated groups reached 80.4 % and 79.8 % ( P = 0.911 ) , with reflux symptom scores of 0.22 and 0.14 ( P = 0.588 ) .
RESULTS	Healing rates of esophagitis in the H. pylori positive uneradicated and H. pylori negative groups were , respectively , 79.8 % and 82.2 % ( P = 0.848 ) ; reflux symptom scores were 0.14 and 0.21 ( P = 0.546 ) .
CONCLUSIONS	Based on esomeprazole therapy , H. pylori infection and eradication have no significant effect on reflux esophagitis therapy .

###24730757
BACKGROUND	Residual walking deficits are common in people after stroke .
BACKGROUND	Treadmill training can increase walking speed and walking distance .
BACKGROUND	A new way to increase the challenge of walking is to walk backwards .
BACKGROUND	Backward treadmill walking may provide advantages by promoting improvement in balance , walking spatiotemporal parameters and quality that may reflect in improving walking distance .
OBJECTIVE	This study will test the hypothesis that backward treadmill walking is superior to forward treadmill walking in improving walking capacity , walking parameters , quality and balance in people with stroke .
METHODS	A prospective , single-blinded , randomized trial will randomly allocate 88 community-dwelling people after stroke into either an experimental or control group .
METHODS	The experimental group will undertake 30-min sessions of backward treadmill walking , three-days/week for six-weeks , while the control group will undertake the same dose of forward treadmill walking .
METHODS	Training will begin at the baseline overground walking speed and will increase each week by 10 % of baseline speed .
RESULTS	The primary outcome will be distance walked in the 6-min Walk Test .
RESULTS	Secondary outcomes will be walking speed , step length , cadence , and one-leg stance time .
RESULTS	Outcomes will be collected by a researcher blinded to group allocation at baseline ( Week 0 ) , at the end of training period ( Week 6 ) , and three-months after the cessation of intervention ( Week 18 ) .
CONCLUSIONS	If backward treadmill walking can improve walking capacity more than forward treadmill training in stroke , it may have broader implications because walking capacity has been shown to predict physical activity level and community participation .

###25329822
BACKGROUND	Despite its widespread use , the beneficial effect of low-dose fentanyl administered at induction of anesthesia on perioperative outcomes has not been studied in the ambulatory setting .
BACKGROUND	Therefore , this study was designed to test the hypothesis that administration of small-dose fentanyl vs. saline during induction reduces coughing and movements without adversely affecting recovery after day-surgery .
METHODS	One hundred consenting outpatients scheduled to undergo superficial surgical procedures under general anesthesia with a laryngeal mask airway ( LMA ) device for airway management were randomly assigned to one of two treatment groups : control ( n = 50 ) or fentanyl ( n = 50 ) .
METHODS	After administration of 2 ml of the unlabelled study medication containing either fentanyl ( 100 g ) or saline , anesthesia was induced with lidocaine 30-50 mg and propofol 2 mg/kg IV followed by the insertion of an LMA device .
METHODS	General anesthesia was maintained using a propofol infusion , 75 g/kg/min , and desflurane ( 2-5 % end-tidal ) in 100 % oxygen .
RESULTS	Coughing was observed in six ( 12 % ) and ten ( 20 % ) in the fentanyl and control group , respectively ( P = 0.41 ) .
RESULTS	The incidence of movements during surgery was lower in the fentanyl group ( 18 % vs. 31 % , P < 0001 ) .
RESULTS	There were no significant differences in early and late recovery times or pain scores between the two groups .
CONCLUSIONS	Administration of a small-dose of fentanyl at induction of anesthesia significantly reduced purposeful movements during day-surgery under propofol-desflurane anesthesia .
CONCLUSIONS	No significant difference was found in coughing or recovery times .

###24818523
OBJECTIVE	To evaluate phenylalanine plasma profile in preterm newborns fed different human milk diets .
METHODS	Twenty-four very-low weight preterm newborns were distributed randomly in three groups with different feeding types : Group I : banked human milk plus 5 % commercial fortifier with bovine protein , Group II : banked human milk plus evaporated fortifier derived from modified human milk , Group III : banked human milk plus lyophilized fortifier derived from modified human milk .
METHODS	The newborns received the group diet when full diet was attained at 15 2 days .
METHODS	Plasma amino acid analysis was performedon the first and last day of feeding .
METHODS	Comparison among groups was performed by statistical tests : one way ANOVA with Tukey 's post-test using SPSS software , version 20.0 ( IBM Corp , NY , USA ) , considering a significance level of 5 % .
RESULTS	Phenylalanine levels in the first and second analysis were , respectively , in Group I : 11.9 1.22 and 29.72 0.73 ; in Group II : 11.72 1.04 and 13.44 0.61 ; and in Group III : 11.3 1.18 and 15.42 0.83 mol/L .
CONCLUSIONS	The observed results demonstrated that human milk with fortifiers derived from human milk acted as a good substratum for preterm infant feeding both in the evaporated or the lyophilized form , without significant increases in plasma phenylalanine levels in comparison to human milk with commercial fortifier .

###24477043
BACKGROUND	Physical inactivity , inadequate dietary protein , and low-grade systemic inflammation contribute to age-related muscle loss , impaired function , and disability .
OBJECTIVE	We assessed the effects of progressive resistance training ( PRT ) combined with a protein-enriched diet facilitated through lean red meat on lean tissue mass ( LTM ) , muscle size , strength and function , circulating inflammatory markers , blood pressure , and lipids in elderly women .
METHODS	In a 4-mo cluster randomized controlled trial , 100 women aged 60-90 y who were residing in 15 retirement villages were allocated to receive PRT with lean red meat ( 160 g cooked ) to be consumed 6 d/wk [ resistance training plus lean red meat ( RT+M eat ) group ; n = 53 ] or control PRT [ 1 serving pasta or rice/d ; control resistance training ( CRT ) group ; n = 47 ) ] .
METHODS	All women undertook PRT 2 times/wk and received 1000 IU vitamin D3/d .
RESULTS	The mean ( SD ) protein intake was greater in the RT+M eat group than in the CRT group throughout the study ( 1.3 0.3 compared with 1.1 0.3 g kg d , respectively ; P < 0.05 ) .
RESULTS	The RT+M eat group experienced greater gains in total body LTM ( 0.45 kg ; 95 % CI : 0.07 , 0.84 kg ) , leg LTM ( 0.22 kg ; 95 % CI : 0.02 , 0.42 kg ) , and muscle strength ( 18 % ; 95 % CI : 0.03 , 0.34 ) than did the CRT group ( all P < 0.05 ) .
RESULTS	The RT+M eat group also experienced a 10 % greater increase in serum insulin-like growth factor I ( P < 0.05 ) and a 16 % greater reduction in the proinflammatory marker interleukin-6 ( IL-6 ) ( P < 0.05 ) after 4 mo. .
RESULTS	There were no between-group differences for the change in blood lipids or blood pressure .
CONCLUSIONS	A protein-enriched diet equivalent to 1.3 g kg d achieved through lean red meat is safe and effective for enhancing the effects of PRT on LTM and muscle strength and reducing circulating IL-6 concentrations in elderly women .
CONCLUSIONS	This trial was registered at the Australian Clinical Trials Registry as ACTRN12609000223235 .

###26218723
BACKGROUND	Actinic keratoses ( AKs ) are a common premalignant skin condition .
BACKGROUND	Many treatments are available for AKs .
BACKGROUND	Photodynamic therapy ( PDT ) is one of the most effective treatments .
BACKGROUND	However , major concerns exist on the possibility of PDT-induced DNA-mutagenesis/immunosuppression , leading to AKs recurrence/treatment failure .
BACKGROUND	An extract ( PLE ) from the fern polypodium leucotomos reduces UV-induced immunosuppression and mutagenesis .
OBJECTIVE	To assess the ability of PLE to enhance the efficacy of PDT treatment , reducing AKs recurrence on the scalp .
METHODS	Thirty-four bald patients presenting at least two AKs on the scalp were alternatively assigned to two groups .
METHODS	Both groups underwent two PDT-sessions one-week apart .
METHODS	The first group began oral PLE supplementation one week after the last PDT session .
METHODS	Evaluation of the effect of PLE supplementation was performed by direct inspection of the bald areas , lesions count , and photodynamic diagnosis assessment at 2 and 6 months .
RESULTS	Both groups were homogeneous in terms of skin phototype and previous UV exposure .
RESULTS	Mean age was 75.7 7.8 years and 76.5 5.5 years , respectively .
RESULTS	Both treatment modalities were successful in reducing AKs number ( p < .001 ) .
RESULTS	However , PLE supplementation increased clearance rate compared with PDT alone ( p = .040 ) .
CONCLUSIONS	Polypodium leucotomos improves PDT clearance and decreases AK recurrence rate at 6 months , suggesting its use as a complementary agent in the treatment of field cancerization .

###26126062
BACKGROUND	Type 2 diabetes mellitus is a chronic condition that requires ongoing , life-long care in order to be controlled .
OBJECTIVE	The aims of the study were to assess the effect of nursing case management on glycated hemoglobin ( HbA1c ) levels compared to usual care in people with type 2 diabetes mellitus and to determine if effects of nursing case management varied by gender , age , duration of disease , education , and income .
METHODS	This is a pragmatic clinical trial , conducted in the municipality of Bandeirantes , Paran , Brazil , in 2011 and 2012 .
METHODS	Eighty individuals were recruited and randomized equally to receive nursing case management or usual care .
METHODS	Covariates were sociodemographic and clinical factors .
METHODS	The outcome was HbA1c measured at baseline , 6 months , and 12 months .
RESULTS	The sample consisted predominately of women ; most had been diagnosed with type 2 diabetes mellitus within the previous 5 years .
RESULTS	Mean age was 50.14 ( SD = 7.00 ) , with 5.27 ( SD = 4.39 ) years of schooling and an average HbA1c of 9.90 % ( SD = 2.49 ) .
RESULTS	Hemoglobin A1c was reduced from an average of 10.33 % to 9.0 % ( p < .01 ) in the nursing case management group and from 9.57 % to 8.93 % ( p = .05 ) in the usual care group ; the group by time effect was not significant .
RESULTS	Case management effects varied by younger age ( p = .05 ) , duration of type 2 diabetes less than 5 years ( p = .03 ) , up to 4 years of schooling ( p = .04 ) , and being in the lowest-income stratum ( p = .02 ) .
CONCLUSIONS	Both groups showed a statistically significant reduction of HbA1c at 6 and 12 months following baseline .
CONCLUSIONS	The difference in proportional reduction of HbA1c between groups was not statistically significant .

###24612448
OBJECTIVE	To establish and evaluate a systematic training programme to be included into the ophthalmologic resident curriculum .
METHODS	Medical students ( n = 20 ) within a year from graduation and with no previous ophthalmic experience were included in this prospective study and randomized into two groups .
METHODS	Group A ( n = 10 ) completed the Eyesi cataract simulator training programme once a week for 4 weeks , while Group B ( n = 10 ) completed it once a week at the first and the last week .
METHODS	Two cataract surgeons were used to determine two different levels of reference scores .
METHODS	Score per analysed module [ two different levels of Capsulorhexis ( A and B ) , Hydromaneuver , Phaco divide and conquer ] , Overall score , Total time , Cornea injury , Capsule rupture and Capsule damage by ultrasound were recorded .
RESULTS	Group A outperformed Group B in several modules , reached a significant higher number of reference scores ( p < 0.01 ) and caused fewer complications with regard to Capsule rupture ( p = 0.01 ) and Capsule damage by ultrasound ( p < 0.05 ) .
RESULTS	Both Groups A and B improved their performance and also became more time efficient ( p < 0.01 for both groups ) .
RESULTS	Group A showed positive learning curves for Overall score ( p < 0.01 ) , Capsulorhexis A ( p < 0.01 ) , Capsulorhexis B ( p < 0.01 ) and Hydromaneuver ( p = 0.01 ) .
RESULTS	Group B showed a significant improvement for Overall score ( p < 0.01 ) , Hydromaneuver ( p = 0.02 ) and Phaco divide and conquer ( p < 0.01 ) .
CONCLUSIONS	Repetitive training with a systematic training programme , based on validated modules in the Eyesi simulator , was shown to improve simulated cataract surgery skills .
CONCLUSIONS	Higher level of skills and more reference scores were reached with more training .
CONCLUSIONS	Furthermore , the programme was optimized to be applied into the standard ophthalmological curriculum for cataract surgery training .

###25904494
BACKGROUND	Late recurrence of atrial fibrillation ( AF ) after radiofrequency ablation remains significant .
BACKGROUND	Asymptomatic recurrence poses a difficult clinical problem as it is associated with an equally increased risk of stroke and death compared with symptomatic AF events .
BACKGROUND	Meta-analyses reveal that no single preablation patient characteristic efficiently predicts these AF recurrences .
BACKGROUND	This study aimed to evaluate the prognostic value of premature atrial complex ( PAC ) occurrence with regard to the risk of late AF recurrence after radiofrequency ablation .
RESULTS	The study cohort consisted of 124 patients with 7-day Holter recordings at 6 months post radiofrequency ablation for AF .
RESULTS	No patients had AF recurrence before this time .
RESULTS	Patients were followed-up every 6 months .
RESULTS	Holter-detected PACs were defined as any supraventricular complexes occurring > 30 % earlier than expected .
RESULTS	During a median follow-up of 4.2 years ( first quartile to third quartile [ Q1-Q3 ] = 1.6-4 .5 ) , 32 patients ( 26 % ) had late recurrences of AF at a median of 462 days ( Q1-Q3 = 319-1026 ) post radiofrequency ablation .
RESULTS	The number of PACs per 24 hours was 248 ( Q1-Q3 = 62-1026 ) in patients with and 77 ( Q1-Q3 = 24-448 ) in patients without recurrence of AF ( P = 0.02 ) .
RESULTS	Multivariate analysis of the risk of late AF recurrence found 142 PACs per 24 hours to have a hazard ratio 2.84 ( confidence interval , 1.26-6 .43 ) , P = 0.01 .
CONCLUSIONS	This study showed that occurrence of 142 PACs per day at 6 months after PVI was independently associated with a significantly increased risk of late AF recurrence .
CONCLUSIONS	These results could have important clinical implications for the design of post-PVI follow-up .
BACKGROUND	URL : http://www.anzctr.org.au .
BACKGROUND	Unique identifier : ACRTN12606000467538 .

###25017268
OBJECTIVE	Distal radius fracture ( DRF ) in postmenopausal women is often the first clinical sign of osteoporosis ( OP ) .
OBJECTIVE	Despite the availability of effective treatments , only a minority of patients who sustain a fragility fracture are tested for OP .
OBJECTIVE	The purpose of this study was to examine whether a simple intervention by the hospital staff increases rates of OP workup .
METHODS	We conducted a prospective randomized clinical trial .
METHODS	Ninety nine patients after DRF were randomized to two groups .
METHODS	Both groups were contacted after their fracture and were asked to answer a questionnaire and were informed about the possible relationship between DRF and OP .
METHODS	In the intervention group , patients were sent an explanatory pamphlet and a letter to their primary care physician .
METHODS	An additional survey was conducted to establish whether the intervention improved the number of patients who undergo OP workup .
RESULTS	The intervention increased the proportion of patients who turned to their primary care physician from 22.9 % to 68.6 % , and increased the proportion of patients undergoing OP workup from 14.3 % to 40 % ( p < 0.001 ) .
CONCLUSIONS	Women with DRF who receive an explanation about possible OP implications and are sent explanatory materials are more likely to undergo OP workup .

###24842445
OBJECTIVE	The aims of the study were to clarify the occurrence of disturbance in surgical wound healing ( DSWH ) after surgery of zygomatic complex ( ZC ) fractures and to determine whether perioperatively applied dexamethasone increases the risk for DSWH .
METHODS	Of 64 patients who were included in a single-blind prospective trial , 33 perioperatively received a total dose of 10 mg or 30 mg of dexamethasone .
METHODS	The remaining 31 patients served as controls .
RESULTS	DSWH occurred in 9 patients ( 14.1 % ) .
RESULTS	Occurrence of DSWH was 24.4 % in patients who received dexamethasone and 3.2 % in controls .
RESULTS	The association between DSWH and dexamethasone was significant ( P = .016 ) .
RESULTS	Intraoral approach also was associated with DSWH significantly ( P = .042 ) .
RESULTS	No association emerged between DSWH and age , gender , time span from accident to surgery , or duration of surgery .
CONCLUSIONS	DSWH occurred significantly more frequently in patients who received perioperative dexamethasone .
CONCLUSIONS	Because of increased risk of DSWH , perioperative dexamethasone can not be recommended in open reduction and fixation of ZC fractures .

###24709765
OBJECTIVE	To assess the explanatory power of disease severity and health-related quality of life ( HRQOL ) on absenteeism and presenteeism in a working population suffering from depression and/or anxiety disorders .
METHODS	We used data of a large , multicenter , randomized trial ( n = 644 ) .
METHODS	Pearson chi-squared tests , analysis of variance , and multinomial logistic regression analyses were performed to explore associations of the type of the disorder and HRQOL with different types of productivity losses .
METHODS	Multivariate regression analyses were performed to assess associations with the duration of absenteeism .
RESULTS	The type of the disorder , disease severity , and HRQOL were associated with different types of productivity losses .
RESULTS	Health-related quality of life and age were significantly associated with the duration of absenteeism .
CONCLUSIONS	Our findings indicate that HRQOL may significantly explain the type of productivity loss as well as the duration of absenteeism .

###25723140
OBJECTIVE	In resource-limited settings without safe alternatives to breastfeeding , the WHO recommends exclusive breastfeeding and antiretroviral ( ARV ) prophylaxis .
OBJECTIVE	Given the high prevalence of anemia among HIV-infected women , mothers and their infants ( through fetal iron accretion ) may be at risk of iron deficiency .
OBJECTIVE	We assessed the effects of maternal micronutrient-fortified lipid-based nutrient supplements ( LNS ) and maternal ARV treatment or infant ARV prophylaxis on maternal and infant iron status during exclusive breastfeeding from birth to 24 weeks .
METHODS	The Breastfeeding , Antiretrovirals , and Nutrition study was a randomized controlled trial conducted in Lilongwe , Malawi , from 2004 to 2010 .
METHODS	HIV-infected mothers ( CD4 > 200 cells/L ) and their infants were randomly assigned to 28-week interventions : maternal LNS/maternal ARV ( n = 424 ) , maternal LNS/infant ARV ( n = 426 ) , maternal LNS ( n = 334 ) , maternal ARV ( n = 425 ) , infant ARV ( n = 426 ) , or control ( n = 334 ) .
METHODS	Longitudinal models tested intervention effects on hemoglobin ( Hb ) .
METHODS	In a subsample ( n = 537 ) with multiple iron indicators , intervention effects on Hb , transferrin receptors ( TfR ) , and ferritin were tested with linear and Poisson regression .
RESULTS	In longitudinal models , LNS effects on maternal and infant Hb were minimal .
RESULTS	In subsample mothers , maternal ARVs were associated with tissue iron depletion ( TfR > 8.3 mg/L ) ( risk ratio : 3.1 , P < 0.01 ) , but not in ARV-treated mothers receiving LNS ( P = 0.17 ) .
RESULTS	LNS without ARVs was not associated with iron deficiency or anemia ( P > 0.1 ) .
RESULTS	In subsample infants , interventions were not associated with impaired iron status ( all P > 0.1 ) .
CONCLUSIONS	Maternal ARV treatment with protease inhibitors is associated with maternal tissue iron depletion ; but LNS mitigates adverse effects .
CONCLUSIONS	ARVs do not seem to influence infant iron status ; however , extended use needs to be evaluated .

###25837193
OBJECTIVE	This study examined the sparing effect of sufentanil on the median effective concentration ( EC ) of epidural ropivacaine in elderly patients undergoing elective transurethral resection of prostate ( TURP ) .
METHODS	This was a prospective randomized double-blind dose-response study .
METHODS	Fifty eight elderly patients with American Society of Anesthesiologists physical status I-II who were scheduled for TURP surgery under epidural anesthesia were randomly allocated to a group receiving 15 mL of ropivacaine ( group R ) or a group receiving ropivacaine plus 5 g of sufentanil ( group RS ) .
METHODS	The concentration of ropivacaine was determined by a Dixon 's up-and-down sequential allocation .
METHODS	The first participant received 0.3 % of ropivacaine in both groups and subsequent concentrations were determined by the response of the previous patient in the same group .
METHODS	The EC of epidural ropivacaine was analyzed using the Dixon and Massey method .
RESULTS	The EC of ropivacaine during TURP surgery was 0.186 % ( 95 % confidence interval , 0.173-0 .200 % ) in group R , and 0.136 % ( 95 % confidence interval , 0.127-0 .144 % ) in group RS ( p < 0.01 ) .
RESULTS	No differences in Bromage scale of motor block examination and the onset time of sensory block were observed .
CONCLUSIONS	Administration of 5 g of epidural sufentanil caused a 37 % reduction in the EC of epidural ropivacaine in elderly patients who underwent TURP surgery .
CONCLUSIONS	Thus , sufentanil addition during surgery of TURP can decrease the dose of ropivacaine anesthesia required .

###24475766
BACKGROUND	The National Institute for Health and Clinical Excellence in the UK has recommended that the effectiveness of ongoing exercise referral schemes to promote physical activity should be examined in research trials .
BACKGROUND	Recent empirical evidence in health care and physical activity promotion contexts provides a foundation for testing the feasibility and impact of a Self Determination Theory-based ( SDT ) exercise referral consultation .
METHODS	An exploratory cluster randomised controlled trial comparing standard provision exercise referral with an exercise referral intervention grounded in Self Determination Theory .
METHODS	Individuals ( N = 347 ) referred to an exercise referral scheme were recruited into the trial from 13 centres.Outcomes and processes of change measured at baseline , 3 and 6-months : Minutes of self-reported moderate or vigorous physical activity ( PA ) per week ( primary outcome ) , health status , positive and negative indicators of emotional well-being , anxiety , depression , quality of life ( QOL ) , vitality , and perceptions of autonomy support from the advisor , need satisfaction ( 3 and 6 months only ) , intentions to be active , and motivational regulations for exercise.Blood pressure and weight were assessed at baseline and 6 months .
RESULTS	Perceptions of the autonomy support provided by the health and fitness advisor ( HFA ) did not differ by arm .
RESULTS	Between group changes over the 6-months revealed significant differences for reported anxiety only .
RESULTS	Within arm contrasts revealed significant improvements in anxiety and most of the Dartmouth CO-OP domains in the SDT arm at 6 months , which were not seen in the standard exercise referral group .
RESULTS	A process model depicting hypothesized relationships between advisor autonomy support , need satisfaction and more autonomous motivation , enhanced well being and PA engagement at follow up was supported .
CONCLUSIONS	Significant gains in physical activity and improvements in quality of life and well-being outcomes emerged in both the standard provision exercise referral and the SDT-based intervention at programme end .
CONCLUSIONS	At 6-months , observed between arm and within intervention arm differences for indicators of emotional health , and the results of the process model , were in line with SDT .
CONCLUSIONS	The challenges in optimising recruitment and implementation of SDT-based training in the context of health and leisure services are discussed .
BACKGROUND	The trial is registered as Current Controlled trials ISRCTN07682833 .

###25043067
BACKGROUND	Drug-eluting stents ( DES ) with durable polymer have significantly reduced restenosis and target vessel revascularization compared with bare metal stents .
BACKGROUND	Durable polymer has been linked with persistent inflammation of vessel wall and delayed endothelial healing that may increase the risk of late and very late stent thrombosis .
BACKGROUND	This study sought to evaluate the efficacy and safety of HELIOS completed biodegradable polymer sirolimus-eluting stent ( SES ) in de novo coronary lesions .
METHODS	Totally , 287 patients with one or two de novo coronary lesions ( lesion length 38 mm and reference vessel diameter 2.5-4 .0 mm ) were enrolled in the HOPE study , a prospective , multicenter , randomized , non-inferiority trial .
METHODS	Patients were randomized to treatment either with HELIOS completed biodegradable polymer SES ( n = 142 ) or PARTNER durable polymer SES ( n = 145 ) .
METHODS	The primary endpoint was angiographic in-stent late lumen loss ( LLL ) at 9-month follow-up .
METHODS	The secondary endpoint included stent thrombosis and major adverse cardiac events including cardiac death , myocardial infarction ( MI ) and target lesion revascularization ( TLR ) .
RESULTS	The 9-month in-stent LLL in the HELIOS group was similar to the PARTNER group , ( 0.16 0.22 ) mm vs. ( 0.19 0.30 ) mm ( P = 0.28 ) .
RESULTS	The difference and 95 % confidence interval were -0.03 ( -0.09 , 0.04 ) , and the P value for non-inferiority < 0.01 .
RESULTS	Major adverse cardiovascular event ( MACE ) occurred in 7.9 % vs. 8.2 % , MI in 2.4 % vs. 3.0 % , TLR in 5.5 % vs. 3.0 % , and stent thrombosis in 0 vs. 1.5 % ; and events were comparable between the HELIOS group and PARTNER group at three-year follow-up ( all P > 0.05 ) .
RESULTS	The three-year cardiac death was lower in the HELIOS group , but with no significant difference , 0 vs. 3.0 % ( P = 0.12 ) .
CONCLUSIONS	In the HOPE trial , the novel completed biodegradable polymer SES HELIOS was non-inferior to the durable polymer SES PARTNER with respect to nine-month in-stent LLL in de novo coronary lesions .
CONCLUSIONS	The incidence of other clinical endpoints was low for both of the stents in three-year follow-up .

###25043862
OBJECTIVE	Postoperative atrial fibrillation ( POAF ) is the most frequent complication arising after cardiac surgery , occurring in 30 % of cases .
OBJECTIVE	Amiodarone is the most effective drug for prophylaxis and treatment .
OBJECTIVE	However , because of significant extracardiac side effects , only high-risk patients are eligible for prophylactic amiodarone therapy .
OBJECTIVE	We performed a randomized prospective study of 100 patients undergoing cardiac surgery with epicardial application of amiodarone-releasing hydrogel to determine the effectiveness of preventing POAF .
METHODS	After institutional review board approval , 100 patients , from January 2012 to July 2013 , who had undergone cardiac surgery , were randomized to 2 equal groups .
METHODS	The study group received poly-based hydrogel with amiodarone sprayed diffusely over the epicardium .
METHODS	The control group underwent the procedure without the spray .
METHODS	Continuous telemetry monitored for POAF , and amiodarone levels in the atria , plasma , and tissue were measured postoperatively .
METHODS	Daily electrocardiographic parameters were measured until postoperative day 14 .
RESULTS	The incidence of POAF was significantly less in the study group , with 4 of 50 patients ( 8 % ) incurring atrial fibrillation compared with 13 of 50 patients ( 26 % ) in the control group ( P < .01 ) .
RESULTS	The mean amiodarone concentrations in the atria ( 12.06 3.1 ) were significantly greater than those in the extracardiac tissues ( 1.32 0.9 ; P < .01 ) .
RESULTS	The plasma amiodarone levels remained below the detection limit ( < 8 g/mL ) during the 14 days of follow-up .
RESULTS	Bradycardia was observed less in the study group ( 76 29 ) than in the control group ( 93 18 ; P < .01 ) .
CONCLUSIONS	Epicardial application of amiodarone-releasing adhesive hydrogel is a less invasive , well-tolerated , quick , and effective therapeutic option for preventing POAF at minimal risk of extracardiac adverse side effects .

###24502414
BACKGROUND	Many patients with cervical disc disease require leave from work , due to long-lasting , complex symptoms , including chronic pain and reduced levels of physical and psychological function .
BACKGROUND	Surgery on a few segmental levels might be expected to resolve disc-specific pain and reduce neurological deficits , but not the non-specific neck pain and the frequent illness .
BACKGROUND	No study has investigated whether post-surgery physiotherapy might improve the outcome of surgery .
BACKGROUND	The main purpose of this study was to evaluate whether a well-structured rehabilitation programme might add benefit to the customary post-surgical treatment for cervical disc disease , with respect to function , disability , work capability , and cost effectiveness .
METHODS	This study was designed as a prospective , randomised , controlled , multi-centre study .
METHODS	An independent , blinded investigator will compare two alternatives of rehabilitation .
METHODS	We will include 200 patients of working age , with cervical disc disease confirmed by clinical findings and symptoms of cervical nerve root compression .
METHODS	After providing informed consent , study participants will be randomised to one of two alternative physiotherapy regimes ; ( A ) customary treatment ( information and advice on a specialist clinic ) ; or ( B ) customary treatment plus active physiotherapy .
METHODS	Physiotherapy will follow a standardised , structured programme of neck-specific exercises combined with a behavioural approach .
METHODS	All patients will be evaluated both clinically and subjectively ( with questionnaires ) before surgery and at 6 weeks , 3 months , 6 months , 12 months , and 24 months after surgery .
METHODS	The main outcome variable will be neck-specific disability .
METHODS	Cost-effectiveness will also be calculated .
CONCLUSIONS	We anticipate that the results of this study will provide evidence to support physiotherapeutic rehabilitation applied after surgery for cervical radiculopathy due to cervical disc disease .
BACKGROUND	ClinicalTrials.gov identifier : NCT01547611 .

###25234181
BACKGROUND	The influence of size on the effectiveness of nasobiliary catheters has not yet been studied .
BACKGROUND	We compared biliary drainage effectiveness and procedure-related discomfort and adverse events in 5 French ( Fr ) and 7 Fr nasobiliary catheters .
METHODS	We prospectively studied 100 patients undergoing endoscopic biliary drainage for obstructive jaundice , who were randomly allocated to a 5 Fr or 7 Fr nasobiliary catheter group .
METHODS	As the primary endpoint , the effectiveness was evaluated by the serum total bilirubin decreasing rate and the success rate of jaundice relief .
METHODS	As the secondary endpoint , the degree of discomfort was investigated using a questionnaire survey after catheter removal .
RESULTS	The bilirubin decrease rate was significantly higher in the 7 Fr catheter group than in the 5 Fr group ( 53.0 21.4 % vs 40.5 29.9 % , respectively ; P = 0.019 ) .
RESULTS	The success rate of jaundice relief tended to be higher in the 7 Fr catheter group , although the difference was not statistically significant ( 98 % vs 88 % , respectively ; P = 0.056 ) .
RESULTS	The questionnaire survey demonstrated that total discomfort was significantly greater in the 7 Fr group ( 3.9 1.5 vs 3.2 1.4 , respectively ; P = 0.018 ) .
RESULTS	Larger-diameter catheters tended to increase difficulty in eating , although the difference between the groups was not statistically significant .
CONCLUSIONS	7 Fr nasobiliary catheters are recommended for patients requiring rapid and reliable relief of obstructive jaundice .
CONCLUSIONS	However , because they can cause greater discomfort , 5 Fr nasobiliary catheters are preferred in other settings .
BACKGROUND	On July 1 , 2012 ; UMIN000008288 ( Japan Primary Registries Network ) .

###25994853
BACKGROUND	The recommended dose of erlotinib is 150mg daily either 1h before a meal ( complete fasting ) or 2h after a meal ( 2h post-meal ) , because of the food effect .
METHODS	We conducted a cross-over pharmacokinetic study to compare the fed bioequivalence in the two conditions .
RESULTS	Twenty-three patients with non-small cell lung cancer were included in the analysis .
RESULTS	AUC0-24 and C max in the 2-h post-meal status were significantly higher than in the complete fasting status ( GMR = 1.33 , P < 0.001 ; GMR = 1.44 , P < 0.001 , respectively ) .
RESULTS	However , because the concentration of erlotinib did not reach the steady state within 7days in the complete fasting state , we conducted analyses only on day 14 , which showed no significant difference in AUC0-24 or C max between the two conditions .
RESULTS	The more rapid increase in AUC0-24 and C min did not produce any earlier and more severe toxic events .
CONCLUSIONS	The AUC0-24 increased significantly faster ( 48-53 % greater ) in the 2-h post-meal status than in complete fasting status , which suggested that the two gastric emptying states might differ in their absorption .
CONCLUSIONS	However , there was no clinically significant difference in bioavailability or toxicity between the two clinically used fed conditions at least in 14days .

###25262475
OBJECTIVE	Percutaneous tunneling ( hydrodissection ) in the neck and anterior chest in patients undergoing robotic thyroidectomy leads to significant hemodynamic responses such as increases in blood pressure and heart rate .
OBJECTIVE	We evaluated whether a single preoperative dexmedetomidine injection attenuated hemodynamic responses to hydrodissection by reducing the half-maximal effective concentration ( EC50 ) of remifentanil needed to maintain hemodynamic stability during hydrodissection .
METHODS	Forty-one patients undergoing robot-assisted endoscopic thyroidectomy were randomly allocated to one of the two groups-group D ( n = 22 ) and group C ( n = 19 ) patients received dexmedetomidine 1g/kg and normal saline for 10min before anesthetic induction , respectively .
METHODS	The EC50 of remifentanil for hemodynamic stability during hydrodissection was determined using Dixon 's up-and-down method with initial dose ( 4and 5ng/mL in groups D and C , respectively ) .
METHODS	The concentration of remifentanil for consecutive patients in each group was determined by the response of the previous patient , using increments or decrements of 0.5 ng/mL .
METHODS	Hemodynamic stability during hydrodissection was defined as increased systolic blood pressure < 20 % of baseline .
RESULTS	The EC50 of remifentanil for maintaining hemodynamic stability during hydrodissection was 0.8 ng/mL in group D and 7.3 ng/mL in group C ( p = 0.002 ) .
CONCLUSIONS	A single preoperative dexmedetomidine injection attenuated hydrodissection-induced hemodynamic responses in patients undergoing robotic thyroidectomy .

###24590752
OBJECTIVE	Prenatal lipid-based nutrient supplements ( LNS ) have been shown to improve birth anthropometry .
OBJECTIVE	However , little is known about the effects of such supplements on infant health .
OBJECTIVE	We hypothesized that prenatal LNS compared with multiple micronutrient supplement for pregnant and lactating women would improve survival , growth , and morbidity during infancy .
METHODS	Infants ' weight , length , head , chest , and mid-upper arm circumferences were measured during monthly home visits from birth to 12 months of age in the Micronutriments et Sant de la Mre et de l'Enfant -- 2 trial .
METHODS	Differences in stunting and wasting episodes between study arms were assessed by Cox regression for recurrent event models .
METHODS	Morbidity signs during the 2 weeks before the visits and death cases were also assessed by multilevel analysis accounting for repeated individual measurements .
RESULTS	Infant length-for-age growth ( -0.033 z score/month ; 95 % confidence interval : -0.601 to -0.006 ; P = .018 ) for the LNS group was inferior to that of the control group .
RESULTS	We did not find evidence of significant difference in mortality or morbidity between groups .
CONCLUSIONS	The previously reported positive effect of prenatal LNS on birth length was not sustained during the postnatal phase .
CONCLUSIONS	Prenatal LNS does not appear to make a long-lasting difference in child linear growth .

###24527596
OBJECTIVE	To assess the effect of pulsed electromagnetic fields ( PEMFs ) on balance ability of postmenopausal women with osteoporosis .
METHODS	43 eligible patients were randomly divided into experimental ( n = 24 ) and control ( n = 19 ) groups .
METHODS	Patients in both groups received conventional drug therapy .
METHODS	Meanwhile , patients in the experimental group were given PEMFs once a day for 30 days .
RESULTS	The Berg Balance Scale ( BBS ) scores increased and the timed upand to test ( TUG ) scores , sway index ( forward-backward ) , rectangle area and sway path decreased in the patients in the experimental group ( P < 0.05 ) .
RESULTS	In the patients in the control group , only changes in BBS scores and sway path were statistically significant ( P < 0.05 ) .
RESULTS	The decrease of sway index ( forward-backward ) in the experimental group was greater than that of the control group ( P < 0 01 ) .
CONCLUSIONS	PEMFs can improve the balance ability of patients with post-menopausal osteoporosis .

###25319879
BACKGROUND	The prognostic impact of improvement in health-related quality of life ( QoL ) and its relation to response in cardiac resynchronization therapy ( CRT ) recipients remains unknown .
OBJECTIVE	To assess the correspondence between response to CRT and improvements in QoL and to verify if a change in QoL after pacing influences outcome in CRT patients .
METHODS	Ninety-seven participants of the Triple-Site Versus Standard Cardiac Resynchronization Therapy Trial ( TRUST CRT ) randomized trial , in New York Heart Association class III-IV , QRS width 120 ms , left ventricular ejection fraction 35 % , and significant mechanical dyssynchrony were included .
METHODS	Subjects filled out the Minnesota-QoL questionnaire prior to and 6 months after CRT with defibrillator ( CRT-D ) implantation .
METHODS	Data on major adverse cardiac events ( MACEs : death , heart failure hospitalization , heart transplant ) collected within the next 2.5 years and adjudicated blindly constituted the censoring variables .
RESULTS	Within the first 6 months of resynchronization QoL improved in 81 % , while worsening in 19 % of patients .
RESULTS	Clinical response , but not the echocardiographic one , was associated with improved QoL .
RESULTS	During subsequent 2.5 years MACEs occurred in 37 % of patients ( 23 % died ) .
RESULTS	Subjects without QoL improvement were significantly ( both P < 0.05 ) more prone to experience MACE ( 61 % vs 32 % ) and die ( 44 % vs 18 % ) within the follow-up .
RESULTS	Unimproved QoL increased the probability of future MACE by 2.7 times ( 95 % confidence intervals [ CI ] : 1.26-5 .83 ; P = 0.01 ) and death by 3.2 times ( 95 % CI : 1.23-8 .32 ; P = 0.02 ) independently from clinical and echocardiographic response .
CONCLUSIONS	Clinical response , but not the echocardiographic one , was associated with improved QoL in CRT recipients .
CONCLUSIONS	These preliminary data suggest that lack of improvement in QoL after CRT was associated with a strongly unfavorable prognosis , regardless of functional or echocardiographic response .
CONCLUSIONS	Our results merit further studies with a larger number of patients .

###25427330
OBJECTIVE	To investigate the effect of resin-modified , glass-ionomer cement lining on the quality of posterior resin composite restorations , bonded with a two-step , total-etch or self-etching adhesive , at 1year .
METHODS	Patients with 1-4 moderate-to-deep , primary occlusal caries in molars were informed and recruited .
METHODS	A total of 110 composite restorations were placed in 75 participants , with one of four restorative procedures : ( a ) bonded with a total-etch adhesive ( Single Bond 2 ) ; ( b ) lined with glass-ionomer cement ( Fuji Lining LC ) , and then bonded with total-etch adhesive ; ( c ) bonded with a self-etching adhesive ( Clearfil SE Bond ) ; and ( d ) lined with glass-ionomer cement , and then bonded with self-etching adhesive .
RESULTS	At 1year , 57 patients ( 86 restorations ) attended the recall .
RESULTS	Each of the restorations was evaluated and scored from 1 ( clinically excellent ) to 5 ( clinically poor ) using the following criteria : ( a ) patient satisfaction ; ( b ) fracture and retention ; ( c ) marginal adaptation ; ( d ) recurrent caries ; and ( e ) post-operative sensitivity .
RESULTS	At 1year , the qualities of the restorations were not significantly affected by the placement of glass-ionomer cement lining , regardless of the adhesive used ( P > 0.05 ) .
RESULTS	Most of the restorations were scored 1 for all criteria .
CONCLUSIONS	The benefit of placing a glass-ionomer cement liner in resin composite restoration is questionable .

###24901876
METHODS	This was a prospective study of patients who underwent vertebroplasty ( VP ) at a single institute .
OBJECTIVE	The aim of this study was to assess and compare the clinical outcomes and complications of unilateral and bilateral VP in treating severe vertebral compression fractures .
BACKGROUND	Typically , VP involves cement injection by bilateral transpedicular or extrapedicular approach .
BACKGROUND	Recently , several articles reported that unilateral VP can achieve comparable outcomes in most cases .
BACKGROUND	However , few prospective randomized studies compared the clinical outcomes and complications in treating severe vertebral compression fractures .
METHODS	Thirty-nine patients with 44 severe osteoporotic vertebral compression fractures ( OVCFs ) were randomly allocated into 2 groups adopting unilateral or bilateral VP .
METHODS	Preoperative and postoperative pain scores , back disability , and cement leakage were recorded and compared .
RESULTS	Significant improvement on the visual analog scale and Oswestry disability index scores were noted in each group , and there were no significant differences between the 2 groups .
RESULTS	Cement leakage was seen more in bilateral VP .
CONCLUSIONS	Severe OVCFs should be candidates for VP .
CONCLUSIONS	The unilateral VP can get the same clinical results with fewer complications compared with the bilateral VP .

###25443996
OBJECTIVE	To investigate the impact of a 12-week exercise programme in addition to usual care for post-traumatic stress disorder ( PTSD ) .
METHODS	An assessor-blinded randomized controlled trial was conducted among 81 participants with a DSM-IV-TR diagnosis of primary PTSD .
METHODS	Participants were recruited after admission to an in-patient programme at a private hospital .
METHODS	Participants were randomized to receive either usual care ( n = 42 ) , or exercise in addition to usual care ( n = 39 ) .
METHODS	The exercise intervention involved three , 30-min resistance-training sessions/week and a pedometer-based walking programme .
METHODS	Usual care involved psychotherapy , pharmaceutical interventions , and group therapy .
METHODS	Primary outcome was PTSD symptoms assessed via the PTSD checklist-civilian version ( PCL-C ) .
METHODS	Secondary outcomes included symptoms of depression , anthropometry , physical activity , mobility , strength , and sleep quality .
RESULTS	Participants had a mean ( SD ) age of 47.8 years ( 12.1 ) , 84 % male .
RESULTS	PTSD symptoms in the intervention group significantly reduced compared with the usual care group ( mean difference = -5.4 , 95 % CI -10.5 to -0.3 , P = 0.04 , n = 58 ) .
RESULTS	There were significant between-group differences at follow-up for depressive symptoms , waist circumference , sleep quality , and sedentary time .
CONCLUSIONS	This study provides the first evidence that an exercise intervention is associated with reduced PTSD and depressive symptoms , reduced waist circumference , and improved sleep quality .

###24708300
OBJECTIVE	To evaluate the efficacy and safety of retroperitoneal laparoscopic pyelolithotomy ( RLP ) versus percutaneous nephrolithotomy ( PCNL ) for large renal pelvic calculi using a randomized controlled trial .
METHODS	Patients with large renal pelvic calculi were prospectively randomized using matched-pair analysis ( 1:1 scenario ) into either the RLP group or the PCNL group .
METHODS	The patients in each group underwent the procedure accordingly .
METHODS	Treatment efficacy , safety , and complications were evaluated after surgery .
RESULTS	Finally , 178 eligible patients were included and the demographics and mean stone size of two groups were similar .
RESULTS	We found no significant differences in the mean postoperative hospital stay ( 4.52.3 vs. 4.31.3 days ) , rate of blood transfusion ( 0 % vs. 1.1 % ) , conversion rate ( 0 % vs. 3.4 % ) , and rate of total postoperative complication ( p > 0.05 ) .
RESULTS	The procedural duration and mean drop in hemoglobin levels were significantly lower in the RLP group as compared with the PCNL group ( 90.8733.4 vs. 116.844.4 minutes , p < 0.001 ; 0.90.5 vs. 1.71.3 g/dL , p < 0.001 , respectively ) .
RESULTS	Significant differences were also observed in the stone-free rate ( 98 % vs. 90 % , p = 0.03 ) and postoperative fever rate ( 3.4 % vs. 13.5 % , p = 0.02 ) .
CONCLUSIONS	Current evidence suggests that PCNL and RLP are both effective and safe for the treatment of large renal pelvic calculi .
CONCLUSIONS	Our study shows that , compared with the PCNL approach , RLP for large renal pelvic stone resulted in shorter operative time , less bleeding , less postoperative fever , and a higher stone-free rate .
CONCLUSIONS	Data from larger , multicenter randomized controlled trials of high quality are needed to further confirm our findings .

###25304838
BACKGROUND	Postoperative catheter-related bladder discomfort ( CRBD ) can be a distressing complication for patients in whom a urinary catheter was inserted during an operation .
BACKGROUND	Our randomized , dual-center , clinical trial investigated the effects of butylscopolamine on the prevention of postoperative CRBD in patients undergoing various operations .
METHODS	Adult male patients undergoing elective operations requiring intraoperative urinary catheterization under general anesthesia were enrolled .
METHODS	They were assigned randomly to 2 groups : The butylscopolamine group ( n = 49 ) received 20 mg of butylscopolamine intravenously immediately before the end of the operation ; no medication was given for prevention of CRBD in the control group ( n = 50 ) .
METHODS	The presence and severity of CRBD were assessed at 1 , 2 , and 6 hours postoperatively .
METHODS	Adverse effects of butylscopolamine were also examined .
RESULTS	The overall incidence of CRBD was less in the butylscopolamine group than in the control group ( 31 % vs 66 % , respectively ; P = .001 ) .
RESULTS	The incidence of CRBD at 1 , 2 , and 6 hours postoperatively was also less in the butylscopolamine group ( P = .006 , .04 , and .048 , respectively ) .
RESULTS	In addition , the average severity of CRBD for 6 hours postoperatively was significantly less in the butylscopolamine group than in the control group ( median , 0 [ interquartile range , 0-17 ] vs 22 [ interquartile range , 0-47 ] , respectively ; P = .002 ) .
RESULTS	Adverse effects were comparable between the 2 groups .
CONCLUSIONS	Intravenous administration of butylscopolamine at the end of an operation decreases effectively the incidence and severity of early postoperative CRBD without adverse effects .

###24290734
BACKGROUND	Preclinical studies comparing paclitaxel formulated with polyethoxylated castor oil with the sonicated formulation of liposome-entrapped paclitaxel ( LEP ) have demonstrated that LEP was associated with reduced toxicity while maintaining similar efficacy .
BACKGROUND	Preliminary studies on the pharmacokinetics in patients support earlier preclinical data , which suggested that the LEP Easy-to-Use ( LEP-ETU ) formulation and paclitaxel formulated with castor oil may have comparable pharmacokinetic properties .
OBJECTIVE	Our objectives were : ( 1 ) to determine bioequivalence of paclitaxel pharmaceutically formulated as LEP-ETU ( test ) and paclitaxel formulated with castor oil ( reference ) ; and ( 2 ) to assess the tolerability of LEP-ETU following intravenous administration .
METHODS	Patients with advanced cancer were studied in a randomized , 2-period crossover bioequivalence study .
METHODS	Patients received paclitaxel 175 mg/m ( 2 ) administered as an intravenous infusion over 180 minutes , either as a single-treatment cycle of the test formulation followed by a single-treatment cycle of the reference formulation , or vice versa .
RESULTS	Thirty-two of 58 patients were evaluable and were included in the analysis for bioequivalence .
RESULTS	Mean total paclitaxel Cmax values for the test and reference formulations were 4955.0 and 5108.8 ng/mL , respectively .
RESULTS	Corresponding AUC0 - values were 15,853.8 and 18,550.8 ngh/mL , respectively .
RESULTS	Treatment ratios of the geometric means were 97 % ( 90 % CI , 91 % -103 % ) for Cmax and 84 % ( 90 % CI , 80 % -90 % ) for AUC0 - .
RESULTS	These results met the required 80 % to 125 % bioequivalence criteria .
RESULTS	The most frequently reported adverse events after LEP-ETU administration were fatigue , alopecia , and myalgia .
CONCLUSIONS	At the studied dose regimen , LEP-ETU showed bioequivalence with paclitaxel formulated with polyethoxylated castor oil .

###24839206
OBJECTIVE	To assess the efficacy and safety of rilonacept , an interleukin-1 inhibitor , in a randomized , double-blind , placebo-controlled trial .
METHODS	An initial 4-week double-blind placebo phase was incorporated into a 24-week randomized multicenter design , followed by an open-label phase .
METHODS	Seventy-one children who had active arthritis in 2 joints were randomized ( 1:1 ) to the 2 arms of the study .
METHODS	Patients in the rilonacept arm received rilonacept ( loading dose 4.4 mg/kg followed by 2.2 mg/kg weekly , subcutaneously ) beginning on day 0 .
METHODS	Patients in the placebo arm received placebo for 4 weeks followed by a loading dose of rilonacept at week 4 followed by weekly maintenance doses .
METHODS	The primary end point was time to response , using the adapted American College of Rheumatology Pediatric 30 criteria coupled with the absence of fever and taper of the dosage of systemic corticosteroids , using prespecified criteria .
RESULTS	The time to response was shorter in the rilonacept arm than in the placebo arm ( ( 2 ) = 7.235 , P = 0.007 ) .
RESULTS	The secondary analysis , which used the same response criteria , showed that 20 ( 57 % ) of 35 patients in the rilonacept arm had a response at week 4 compared with 9 ( 27 % ) of 33 patients in the placebo arm ( P = 0.016 ) .
RESULTS	Exacerbation of systemic juvenile idiopathic arthritis ( JIA ) was the most common severe adverse event .
RESULTS	More patients in the rilonacept arm had elevated liver transaminase levels ( including levels more than 3 times the upper limit of normal ) compared with those in the placebo arm .
RESULTS	Adverse events were similar in the 2 arms of the study .
CONCLUSIONS	Rilonacept was generally well tolerated and demonstrated efficacy in active systemic JIA .

###25687152
OBJECTIVE	To evaluate the effectiveness of a multilevel and multimodal school-based education program .
METHODS	A cluster randomized controlled trial with 14 secondary schools in Hong Kong and a total of 3713 students ( intervention : 1545 vs control : 2168 ; 40.2 % boys ; mean age SD : 14.72 1.53 years ) were included in the final analysis .
METHODS	The intervention included a town hall seminar , small class workshops , a slogan competition , a brochure , and an educational Web site .
METHODS	Their parents and teachers were offered sleep education seminars .
METHODS	The control schools did not receive any sleep program .
METHODS	Data were collected before and 5 weeks after the intervention .
RESULTS	The students in the intervention group had significantly improved sleep knowledge compared with the control group ( mean difference : 3.64 [ 95 % confidence interval ( CI ) : 3.21 to 4.07 ] ; Cohen 's d = 0.51 ) as measured by using a sleep knowledge questionnaire .
RESULTS	Weekday sleep duration was reduced in both groups , and the significant difference in weekday sleep duration was lost in the intention-to-treat analysis ( mean difference : 0:01 [ 95 % CI : -0:00 to 0:04 ] ) .
RESULTS	In addition , the intervention group had a lower incidence of consuming caffeine-containing energy drinks ( adjusted odds ratio : 0.46 [ 95 % CI : 0.22 to 0.99 ] ) and had better behavioral ( mean difference : -0.56 [ 95 % CI : -1.02 to -0.10 ] ; Cohen 's d = 0.13 ) and mental health ( mean difference : -0.30 [ 95 % CI : -0.15 to -0.46 ] ; Cohen 's d = 0.11 ) outcomes .
CONCLUSIONS	A school-based sleep education program was effective in enhancing sleep knowledge and improving behavioral and mental health , but it had no significant impact on sleep duration or pattern among adolescents .

###24884497
BACKGROUND	Anaemia is a common health problem among pregnant women and a contributing factor with a major influence on maternal mortality in Indonesia .
BACKGROUND	The Four Pillars Approach is a new approach to anaemia in pregnancy , combining four strategies to improve antenatal and delivery care .
BACKGROUND	The primary objective of this study is to measure the effectiveness of the Four Pillars Approach .
BACKGROUND	The barriers , the facilitators , and the patients ' as well as the midwives ' satisfaction with the Four Pillars Approach will also be measured .
METHODS	This study will use a cluster randomised controlled trial .
METHODS	This intervention study will be conducted in the Public Health Centres with basic emergency obstetric care in Yogyakarta Special Province and in Central Java Province .
METHODS	We will involve all the Public Health Centres ( 24 ) with emergency obstetric care in Yogyakarta Special Province .
METHODS	Another 24 Public Health Centres with emergency obstetric care in Central Java Province which have similarities in their demographic , population characteristics , and facilities will also be involved .
METHODS	Each Public Health Centre will be asked to choose two or three nurse-midwives to participate in this study .
METHODS	For the intervention group , the Public Health Centres in Yogyakarta Special Province , training on the Four Pillars Approach will be held prior to the model 's implementation .
METHODS	Consecutively , we will recruit 360 pregnant women with anaemia to take part in part in the study to measure the effectiveness of the intervention .
METHODS	The outcome measurements are the differences in haemoglobin levels between the intervention and control groups in the third trimester of pregnancy , the frequency of antenatal care attendance , and the presence of a nurse-midwife during labour .
METHODS	Qualitative data will be used to investigate the barriers and facilitating factors , as to nurse-midwives ' satisfaction with the implementation of the Four Pillars Approach .
CONCLUSIONS	If the Four Pillars Approach is effective in improving the outcome for pregnant women with anaemia , this approach could be implemented nationwide and be taken into consideration to improve the outcome for other conditions in pregnancy , after further research .
BACKGROUND	Current Controlled Trials ISRCTN35822126 .

###24438512
BACKGROUND	Progressive Supranuclear Palsy ( PSP ) is a sporadic and progressive neurodegenerative disease which belongs to the family of tauopathies and involves both cortical and subcortical structures .
BACKGROUND	No effective therapy is to date available .
METHODS	Autologous bone marrow ( BM ) mesenchymal stem cells ( MSC ) from patients affected by different type of parkinsonisms have shown their ability to improve the dopaminergic function in preclinical and clinical models .
METHODS	It is also possible to isolate and expand MSC from the BM of PSP patients with the same proliferation rate and immuphenotypic profile as MSC from healthy donors .
METHODS	BM MSC can be efficiently delivered to the affected brain regions of PSP patients where they can exert their beneficial effects through different mechanisms including the secretion of neurotrophic factors.Here we propose a randomized , placebo-controlled , double-blind phase I clinical trial in patients affected by PSP with MSC delivered via intra-arterial injection .
CONCLUSIONS	To our knowledge , this is the first clinical trial to be applied in a no-option parkinsonism that aims to test the safety and to exploit the properties of autologous mesenchymal stem cells in reducing disease progression .
CONCLUSIONS	The study has been designed to test the safety of this `` first-in-man '' approach and to preliminarily explore its efficacy by excluding the placebo effect .
BACKGROUND	NCT01824121 .

###24597923
BACKGROUND	The importance of using technologies such as e-learning in different disciplines is discussed in the literature .
BACKGROUND	Researchers have measured the effectiveness of e-learning in a number of fields.Considering the lack of research on the effectiveness of online learning in dental education particularly in Iran , the advantages of these learning methods and the positive university atmosphere regarding the use of online learning .
BACKGROUND	This study , therefore , aims to compare the effects of two methods of teaching ( virtual versus traditional ) on student learning .
METHODS	This post-test only design study approached 40 , fifth year dental students of Shiraz University of Medical Sciences .
METHODS	From this group , 35 students agreed to participate .
METHODS	These students were randomly allocated into two groups , experimental ( virtual learning ) and comparison ( traditional learning ) .
METHODS	To ensure similarity between groups , we compared GPAs of all participants by the Mann-Whitney U test ( P > 0.05 ) .
METHODS	The experimental group received a virtual learning environment courseware package specifically designed for this study , whereas the control group received the same module structured in a traditional lecture form .
METHODS	The virtual learning environment consisted of online and offline materials .
METHODS	Two identical valid , reliable post-tests that consisted of 40 multiple choice questions ( MCQs ) and 4 essay questions were administered immediately ( 15 min ) after the last session and two months later to assess for knowledge retention .
METHODS	Data were analyzed by SPSS version 20 .
RESULTS	A comparison of the mean knowledge score of both groups showed that virtual learning was more effective than traditional learning ( effect size = 0.69 ) .
CONCLUSIONS	The newly designed virtual learning package is feasible and will result in more effective learning in comparison with lecture-based training .
CONCLUSIONS	However further studies are needed to generalize the findings of this study .

###24294000
BACKGROUND	Cerium oxide nanoparticles ( nanoceria ) are effective at quenching reactive oxygen species ( ROS ) in cell culture and animal models .
BACKGROUND	Although nanoceria reportedly deposit in lungs , their efficacy in conferring lung protection during oxidative stress remains unexplored .
BACKGROUND	Thus , the study evaluated the protective efficacy of nanoceria in rat lung tissue during hypobaric hypoxia .
METHODS	A total of 48 animals were randomly divided into four equal groups ( control [ C ] , nanoceria treated [ T ] , hypoxia [ H ] , and nanoceria treated plus hypoxia [ T+H ] ) .
METHODS	Animals were injected intraperitoneally with either a dose of 0.5 g/kg body weight/week of nanoceria ( T and T+H groups ) or vehicle ( C and H groups ) for 5 weeks .
METHODS	After the final dose , H and T+H animals were challenged with hypobaric hypoxia , while C and T animals were maintained at normoxia .
METHODS	Lungs were isolated and homogenate was obtained for analysis of ROS , lipid peroxidation , glutathione , protein carbonylation , and 4-hydroxynonenal-adduct formation .
METHODS	Plasma was used for estimating major inflammatory cytokines using enzyme-linked immunosorbent assay .
METHODS	Intact lung tissues were fixed and both transmission electron microscopy and histopathological examinations were carried out separately for detecting internalization of nanoparticles as well as altered lung morphology .
RESULTS	Spherical nanoceria of 7-10 nm diameter were synthesized using a microemulsion method , and the lung protective efficacy of the nanoceria evaluated during hypobaric hypoxia .
RESULTS	With repeated intraperitoneal injections of low micromole concentration , we successfully localized the nanoceria in rodent lung without any inflammatory response .
RESULTS	The lung-deposited nanoceria limited ROS formation , lipid peroxidation , and glutathione oxidation , and prevented oxidative protein modifications like nitration and carbonyl formation during hypobaric hypoxia .
RESULTS	We also observed reduced lung inflammation in the nanoceria-injected lungs , supporting the anti-inflammatory properties of nanoceria .
CONCLUSIONS	Cumulatively , these results suggest nanoceria deposit in lungs , confer protection by quenching noxious free radicals during hypobaric hypoxia , and do not evoke any inflammatory response .

###24705731
BACKGROUND	The Alvarado score is a clinical scoring system used in the diagnosis of acute appendicitis .
BACKGROUND	This study aimed to compare the reliability of the Alvarado score and clinical judgment and to refine the score to make it easier to use .
METHODS	In this prospective , randomized study , patients presenting at the authors ' outpatient department with suspected appendicitis during a 1-year period were assigned in weekly alternation to either group A or group B.
METHODS	The group A patients were treated on the basis of their Alvarado score , and the group B patients underwent treatment based on clinical judgment .
METHODS	The correctness of the methods was assessed by evaluation of the final histology .
METHODS	Statistical comparison of the data was performed using SPSS 20 .
RESULTS	The study investigated 269 patients ( 131 in group A and 138 in group B ) .
RESULTS	The groups were homogeneous in terms of mean age , gender , body mass index , and American Society of Anesthesiologists score .
RESULTS	The number of negative appendectomies was 12 ( 9.16 % ) in group A versus 5 ( 3.6 % ) in group B ( p = 0.063 ) .
RESULTS	The clinical judgment had better specificity and sensitivity than the Alvarado score .
RESULTS	For that reason , the specificity of the Alvarado score was refined using statistical methods , with weighting of certain clinical data and inclusion of new ones ( e.g. , ultrasound investigation ) .
RESULTS	Consequently , the area under the curve by receiver operating characteristic analysis gradually increased , and the Alvarado score became more accurate .
CONCLUSIONS	The study findings showed clinical judgment to be more reliable in the diagnosis of acute appendicitis than the Alvarado score , but the score is a useful diagnostic aid , especially for young colleagues .
CONCLUSIONS	The use of the new scoring system has become easier .
CONCLUSIONS	It includes fewer criteria as well as an important and sensitive predictor : the ultrasound investigation .

###25978169
OBJECTIVE	Sirtuin 1 influences gene expression and other cellular functions through deacetylation of histone and nonhistone proteins .
OBJECTIVE	We here sought to determine the effects of a small molecule sirtuin 1 activator , SRT2104 , on inflammation and coagulation induced by lipopolysaccharide in humans .
METHODS	A randomized , double-blind , placebo-controlled study .
METHODS	An academic hospital .
METHODS	Twenty-four healthy humans .
METHODS	All subjects received an intravenous injection with lipopolysaccharide .
METHODS	Subjects were randomized to one of three groups ( n = 8 per group ) : 1 ) pretreatment with oral SRT2104 for 7 days ( 2 g/d ) , 2 ) pretreatment with a single SRT2104 dose ( 2 g ) , or 3 ) placebo .
RESULTS	SRT2104 attenuated lipopolysaccharide-induced release of the cytokines interleukin-6 ( mean peak levels of 58.8 % [ p < 0.05 ] and 80.9 % [ p = 0.078 ] after single and repeated SRT2104 administration , respectively , relative to those measured after placebo treatment ) and interleukin-8 ( mean peak levels of 57.0 % [ p < 0.05 vs placebo ] and 77.1 % [ p < 0.05 vs placebo ] after single and repeated SRT2104 ingestion , respectively , while not affecting tumor necrosis factor - and interleukin-10 release ) .
RESULTS	SRT2104 also reduced the lipopolysaccharide-induced acute phase protein response ( C-reactive protein ) .
RESULTS	SRT2104 inhibited activation of coagulation , as reflected by lower plasma levels of the prothrombin fragment F1 +2 ( mean peak levels 57.9 % [ p < 0.05 ] and 64.2 % [ p < 0.05 ] after single and repeated SRT2104 administration , respectively , relative to those measured after placebo treatment ) .
RESULTS	Activation of the vascular endothelium ( plasma von Willebrand levels ) and the fibrinolytic system ( plasma tissue-type plasminogen activator and plasminogen activator inhibitor type I ) was not influenced by SRT2104 .
CONCLUSIONS	This is the first human study to demonstrate biological anti-inflammatory and anticoagulant responses consistent with the activation of sirtuin 1 by a small molecule .

###26258314
OBJECTIVE	The objective of this study was to compare the long-term outcome of patients with metastatic melanoma vaccinated with 6MHP to that of a group of unvaccinated historical controls .
BACKGROUND	A multipeptide vaccine ( 6MHP ) , designed to induce helper T cells against melanocytic and cancer-testis antigens , has been shown to induce specific Th1-dominant CD4 + T cell responses .
METHODS	The 6MHP vaccine was administered to patients with metastatic melanoma .
METHODS	Circulating CD4 + T cell responses were measured by proliferation or direct IFN-gamma ELIspot assay .
METHODS	Overall survival of vaccinated patients was compared to a group of clinically comparable historical controls using multivariable Cox regression analysis and Kaplan-Meier survival analysis , taking into account age , metastatic site , and resection status .
RESULTS	Across 40 vaccinated patients and 87 controls , resection status ( HR 0.54 , P = 0.004 ) and vaccination ( HR 0.24 , P < 0.001 ) were associated with improved overall survival .
RESULTS	Forty pairs of vaccinated patients and controls were matched by metastatic site , resection status , and age within 10 years .
RESULTS	Median survival was significantly longer for vaccinated patients ( 5.4 vs 1.3 years , P < 0.001 ) .
RESULTS	Among the vaccinated patients , the development of a specific immune response after vaccination was associated with improved survival ( HR 0.35 , P = 0.040 ) .
CONCLUSIONS	Helper peptide vaccination is associated with improved overall survival among patients with metastatic melanoma .
CONCLUSIONS	These data support a randomized prospective trial of the 6MHP vaccine .

###24290148
OBJECTIVE	To examine the effect of reducing questionnaire length on the response rate in a physician survey .
METHODS	A postal four double-page questionnaire on end-of-life decision making was sent to a random sample of 1,100 general practitioners , 400 elderly care physicians , and 500 medical specialists .
METHODS	Another random sample of 500 medical specialists received a shorter questionnaire of two double pages .
METHODS	After 3months and one reminder , all nonresponding physicians received an even shorter questionnaire of one double page .
RESULTS	Total response was 64 % ( 1,456 of 2,269 eligible respondents ) .
RESULTS	Response rate of medical specialists for the four double-page questionnaire was equal to that of the two double-page questionnaire ( 190 and 191 questionnaires were returned , respectively ) .
RESULTS	The total response rate increased from 53 % to 64 % after sending a short one double-page questionnaire ( 1,203-1 ,456 respondents ) .
CONCLUSIONS	The results of our study suggest that reducing the length of a long questionnaire in a physician survey does not necessarily improve response rate .
CONCLUSIONS	To improve response rate and gather more information , researchers could decide to send a drastically shortened version of the questionnaire to nonresponders .

###25464511
BACKGROUND	In mouse models for atopic dermatitis ( AD ) hypothalamus pituitary adrenal axis ( HPA ) dysfunction and neuropeptide-dependent neurogenic inflammation explain stress-aggravated flares to some extent .
BACKGROUND	Lately , cholinergic signaling has emerged as a link between innate and adaptive immunity as well as stress responses in chronic inflammatory diseases .
BACKGROUND	Here we aim to determine in humans the impact of acute stress on neuro-immune interaction as well as on the non-neuronal cholinergic system ( NNCS ) .
METHODS	Skin biopsies were obtained from 22 individuals ( AD patients and matched healthy control subjects ) before and after the Trier social stress test ( TSST ) .
METHODS	To assess neuro-immune interaction , nerve fiber ( NF ) - density , NF-mast cell contacts and mast cell activation were determined by immunohistomorphometry .
METHODS	To evaluate NNCS effects , expression of secreted mammal Ly-6 / urokinase-type plasminogen activator receptor-related protein ( SLURP ) 1 and 2 ( endogenous nicotinic acetylcholine receptor ligands ) and their main corresponding receptors were assessed by quantitative RT-PCR .
RESULTS	With respect to neuro-immune interaction we found higher numbers of NGF + dermal NF in lesional compared to non-lesional AD but lower numbers of Gap43 + growing NF at baseline .
RESULTS	Mast cell-NF contacts correlated with SCORAD and itch in lesional skin .
RESULTS	With respect to the NNCS , nicotinic acetylcholine receptor 7 ( 7nAChR ) mRNA was significantly lower in lesional AD skin at baseline .
RESULTS	After TSST , PGP 9.5 + NF numbers dropped in lesional AD as did their contacts with mast cells .
RESULTS	NGF + NF now correlated with SCORAD and mast cell-NF contacts with itch in non-lesional skin .
RESULTS	At the same time , SLURP-2 levels increased in lesional AD skin .
CONCLUSIONS	In humans chronic inflammatory and highly acute psycho-emotional stress interact to modulate cutaneous neuro-immune communication and NNCS marker expression .
CONCLUSIONS	These findings may have consequences for understanding and treatment of chronic inflammatory diseases in the future .

###25127372
BACKGROUND	The HOT ( Healthy Outcome for Teens ) Project is an innovative online educational intervention for middle school children for prevention of diabetes and obesity by balancing food intake with physical activity .
BACKGROUND	The objective was to improve knowledge , outcome expectations , self-efficacy , and self-reported food intake and skills and to compare a passive online learning ( POL ) control group with an active online learning ( AOL ) treatment group by implementing a social cognitive theory ( SCT ) - grounded online intervention .
METHODS	In total , 214 participants were recruited from three middle schools .
METHODS	Full data were secured for 181 students .
METHODS	Six valid , reliable questionnaires were administered online , pre/post , to both the AOL and POL groups to assess knowledge gain , self-reported intake , and meal planning skills , as well as change in SCT constructs .
RESULTS	Subjects in the AOL group improved significantly for all five categories of planning a meal questionnaire ( P = 0.001 ) and also for outcome expectations for exercise ( P = 0.001 ) .
RESULTS	At postintervention , no significant differences were found for composite scores of exercise self-efficacy , weight efficacy lifestyle , and rapid eating assessment plan questionnaires between AOL versus POL ( by Mann-Whitney test ) .
CONCLUSIONS	We conclude that teens participating in the AOL version of the HOT Project intervention acquired skills for planning a meal and improved outcome expectations for exercise .

###25730929
BACKGROUND	Vegetative dysfunction is observed in 60-90 % of the children presenting with chronic respiratory diseases .
BACKGROUND	Its timely identification and correction increases the effectiveness of the combined rehabilitative treatment of such patients .
METHODS	The vegetative regulation was dynamically evaluated by the analysis of the heart rate variability in 95 patients presenting with bronchial asthma and chronic nonspecific lung diseases .
METHODS	The age of the patients varied from 7 to 16 years .
METHODS	Sixty children received the combined treatment including enteral oxygen therapy , the control group was comprised of 35 patients .
RESULTS	The enteral oxygen therapy eliminated the vegetative disbalance in 80.0 % of the children with bronchial asthma and in 88,0 % of those suffering from chronic nonspecific lung diseases .
RESULTS	The results of the spectral analysis of heart rate variability indicate that the total spectrum power ( TSP ) was significantly increased in the patients of the study group .
RESULTS	This effect was accompanied by the restructuring of wave frequency ranges pointing out to the enhancement of the activity of the sympathetic-adrenal system .
RESULTS	The integral index of adaptive reserves ( AR ) increased from 2.00,6 to 4.70,6 points ( p < 0.001 ) under the influence of enteral oxygen therapy ; this parameter remained practically unaltered in the patients of the control group where it varied from 1.70,8 to 2.00,9 points ( p > 0.05 ) .
RESULTS	More manifest pronounced positive dynamics was observed in the patients presenting with initial vagotonia and the severe or moderate form of the disease .
CONCLUSIONS	The present study has demonstrated the favourable influence of enteral oxygen therapy on the vegetative regulation mechanisms and the adaptive potential of the organism .
CONCLUSIONS	Analysis of the heart rate variability may be a screening method for the evaluation of the effectiveness of the proposed therapeutic modality .

###26480547
OBJECTIVE	To compare the efficacy difference in the treatment of senile insomnia among western , medication , acupuncture and the integrated therapy of acupuncture and western medication .
METHODS	Ninety-eight patients of senile insomnia were randomized into a western medication group ( 30 cases ) , an acupuncture group ( 35 cases ) and an integrated acupuncture and medication group ( 35 cases ) .
METHODS	In the western medication group , estazolam 1mg was prescribed , taken 30 min before going to bed , oryzanol 20 mg , oral administration , three times a day , for 4 weeks totally .
METHODS	In the acupuncture group , the simple acupuncture therapy was applied at Shenmen ( HT 7 ) , Sanyinjiao ( SP 6 ) , Anmian ( Extra ) , Baihui ( GV 20 ) and Sishencong ( EX-HN 1 ) , as well as the supplementary points selected according to the differentiation .
METHODS	The acupuncture treatment was given once a day , 5 treatments a week , for 4 weeks totally .
METHODS	In the integrated acupuncture and medication group , the western medication was combined with acupuncture .
METHODS	The dosage and usage of western medication were same as those in the western medication group ; and acupoints in acupuncture treatment were same as those in the acupuncture group .
METHODS	The treatment lasted for 4 weeks in the three groups .
METHODS	Pittsburgh sleep quality index ( PSQI ) and clinical efficacy were observed before treatment , after 4 weeks ' treatment and in 4 weeks after discontinuity of treatment in the three groups .
RESULTS	Four weeks after treatment , the clinical curative rates were 3.3 % ( 1/30 ) , 21.2 % ( 7/33 ) and 25.7 % ( 9/35 ) in the western medication group , the acupuncture group and the integrated acupuncture and medicines group separately .
RESULTS	The total effective rates were 70.0 % ( 21/30 ) , 93.9 % ( 31/33 ) and 97.1 % ( 34/35 ) in the three groups separately .
RESULTS	The curative rates and the total effective rates in the integrated acupuncture and medication group and the acupuncture group were higher than those in the western medication group separately ( all , P < 0.01 ) .
RESULTS	PSQI scores after 4 Weeks ' treatment were all improved as compared with those before treatment in the three groups ( all P < 0.05 ) .
RESULTS	PSQI score in either the integrated acupuncture and medication group or the acupuncture group was lower than that in the western medication group , indicating the significant difference ( both P < 0.05 ) .
RESULTS	Four weeks after discontinuity of treatment , the efficacy was stable in the acupuncture group and the integrated acupuncture and medication group .
RESULTS	PSQI score did not change as compared with that in the 4th week of treatment .
RESULTS	The score in the western medication group ran back , close to that before treatment ( P > 0.05 ) .
RESULTS	During the treatment , a few patients had dry mouth in the western medication group .
RESULTS	The adverse reactions were not discovered in the other two groups .
CONCLUSIONS	The integrated therapy of acupuncture and medication achieves the quick efficacy on senile insomnia and rapidly relieves the symptoms , with quite high clinical curative rate and total effective rate obtained .
CONCLUSIONS	The long-term efficacy is better than that of western medication .
CONCLUSIONS	The integrated therapy is the first option among the three therapeutic programs .

###24597915
BACKGROUND	Sexual risk is an important , oft-neglected area in addiction treatment .
OBJECTIVE	This report examines computerized sexual risk assessment and client feedback at intake as means of enhancing counselor awareness of client risk behavior during early treatment , as well as any clinical impact of that counselor awareness .
METHODS	In 2009-2011 , new clients at both opiate treatment and drug-free treatment programs endorsed in a computer-assisted assessment at intake 90-day retrospective indices for : being sexually active , having multiple partners , having sex under drug influence , and inconsistently using condoms .
METHODS	Clients were randomly assigned in a 2:1 ratio to receive or not receive a personal feedback report , and those receiving a report chose if a counselor copy was also distributed .
METHODS	Ninety days later , retained clients ( N = 79 ) repeated the assessment and their counselors concurrently reported perceptions of recent client risk behavior .
RESULTS	Based on client reports , pretreatment risk behaviors were prevalent among men and women and remained so during treatment .
RESULTS	A general linear model revealed greater counselor awareness of subsequent client risk behavior with mutual distribution of intake feedback reports to client and counselor , and at the opiate treatment program .
RESULTS	A repeated-measures analysis of variance indicated that counselor awareness did not predict change in temporally stable patterns of sexual risk behavior .
RESULTS	CONCLUSIONS/IMPORTANCE : Findings document that computerized intake assessment of sexual risk and mutually distributed feedback reports prompt greater counselor awareness of clients ' subsequent risk behavior .
RESULTS	Future research is needed to determine how best to prepare counselors to use such awareness to effectively prompt risk reduction in routine care .

###24902406
OBJECTIVE	To assess the sealing properties of four luting materials used for cementation of full cast crowns .
METHODS	40 human premolars were prepared with a chamfer finish line .
METHODS	Stone dies were fabricated and copings were waxed , invested and cast in gold .
METHODS	Ten samples ( n = 10 ) were randomly assigned to four groups .
METHODS	In two groups , resin modified glass-ionomer cements were used , ACTIVA BioACTIVE-CEMENT/BASE/LINER and FujiCem2 ; the third group received the self-adhesive resin cement Embrace WetBond , while the fourth group served as control with a zinc phosphate cement .
METHODS	After cementation , excess cement was removed followed by bench-set for 10 minutes .
METHODS	All samples were stored in water at 37 degrees C and subjected to thermal cycling ( x2000 between 5 and 55 degrees C ) .
METHODS	Subsequently the occlusal surface was reduced exposing the dentin .
METHODS	After sterilization the specimens were subjected to bacterial microleakage with E. faecalis in a dual chamber apparatus for a period of 60 days .
METHODS	Bacterial leakage was checked daily .
METHODS	Data were analyzed using the Kaplan-Meyer survival test .
METHODS	Significant pairwise differences were analyzed using the Log Rank test and the Fishers ' exact test at P < 0.05 .
RESULTS	ACTIVA BioACTIVE-CEMENT/BASE/LINER , FujiCem2 and Embrace WetBond showed the lowest microleakage scores and differed statistically significantly ( P < 0.05 ) from zinc phosphate cement .

###24356166
BACKGROUND	There is no current consensus on the optimal technique for subarachnoid anesthesia in morbidly obese parturients even though some providers prefer the combined spinal-epidural ( CSE ) over single-shot spinal ( SSS ) technique .
BACKGROUND	In this randomized controlled study , we compared the time required for initiation of subarachnoid anesthesia between SSS and CSE techniques in morbidly obese parturients undergoing elective cesarean delivery .
METHODS	Morbidly obese parturients presenting for elective cesarean delivery were randomized to receive subarachnoid anesthesia performed either with a SSS or a CSE technique .
METHODS	The spinal procedure in the sitting position was attempted by an experienced resident for up to 10 minutes , and if unsuccessful , the attending obstetric anesthesiologist assumed control of the procedure .
METHODS	The primary outcome was the time it took from the insertion of the introducer needle ( SSS group ) or insertion of the epidural needle ( CSE group ) to the end of intrathecal injection of drugs ( procedure time ) .
RESULTS	Forty-four patients were enrolled and completed the study .
RESULTS	Three were excluded due to protocol violations .
RESULTS	Of the remaining , 21 patients were in the SSS group and 20 in the CSE group .
RESULTS	Demographic variables and mean ( SD ) body mass index ( 48.7 7.6 kg/m for SSS ; 49.9 8.6 kg/m for CSE ) were not different between groups .
RESULTS	The median [ interquartile range ] for procedure time was 210 [ 116-692 ] seconds and 180 [ 75-450 ] seconds for SSS and CSE groups , respectively ( P = 0.36 ) , while the 95 % confidence interval ( CI ) of the difference was -80 to +180 seconds .
RESULTS	The first operator completed the procedure in < 10 minutes in 71 % of subjects in the SSS group and 95 % of those in the CSE group ( P = 0.09 ) and the 95 % CI of the difference was -2 % to +45 % .
RESULTS	There were more attempts to successful completion of the procedure in the SSS group ( P = 0.007 ) with its 95 % CI of the difference being +1 to +6 .
CONCLUSIONS	Our results suggest that the CSE technique is noninferior to the SS technique in morbidly obese parturients for time of initiation of subarachnoid anesthesia and may be accomplished with fewer attempts than the SSS technique with experienced residents .

###24835849
BACKGROUND	In the acute respiratory distress syndrome ( ARDS ) , inflammation in the lungs and other organs can cause life-threatening organ failure .
BACKGROUND	Inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A reductase ( statins ) can modulate inflammatory responses .
BACKGROUND	Previous observational studies suggested that statins improved clinical outcomes in patients with sepsis .
BACKGROUND	We hypothesized that rosuvastatin therapy would improve clinical outcomes in critically ill patients with sepsis-associated ARDS .
METHODS	We conducted a multicenter trial in which patients with sepsis-associated ARDS were randomly assigned to receive either enteral rosuvastatin or placebo in a double-blind manner .
METHODS	The primary outcome was mortality before hospital discharge home or until study day 60 if the patient was still in a health care facility .
METHODS	Secondary outcomes included the number of ventilator-free days ( days that patients were alive and breathing spontaneously ) to day 28 and organ-failure-free days to day 14 .
RESULTS	The study was stopped because of futility after 745 of an estimated 1000 patients had been enrolled .
RESULTS	There was no significant difference between study groups in 60-day in-hospital mortality ( 28.5 % with rosuvastatin and 24.9 % with placebo , P = 0.21 ) or in mean ( SD ) ventilator-free days ( 15.110.8 with rosuvastatin and 15.111.0 with placebo , P = 0.96 ) .
RESULTS	The groups were well matched with respect to demographic and key physiological variables .
RESULTS	Rosuvastatin therapy , as compared with placebo , was associated with fewer days free of renal failure to day 14 ( 10.15.3 vs. 11.04.7 , P = 0.01 ) and fewer days free of hepatic failure to day 14 ( 10.85.0 vs. 11.84.3 , P = 0.003 ) .
RESULTS	Rosuvastatin was not associated with an increased incidence of serum creatine kinase levels that were more than 10 times the upper limit of the normal range .
CONCLUSIONS	Rosuvastatin therapy did not improve clinical outcomes in patients with sepsis-associated ARDS and may have contributed to hepatic and renal organ dysfunction .
CONCLUSIONS	( Funded by the National Heart , Lung , and Blood Institute and the Investigator-Sponsored Study Program of AstraZeneca ; ClinicalTrials.gov number , NCT00979121 . )

###24261687
BACKGROUND	Determining sample sizes for metabolomic experiments is important but due to the complexity of these experiments , there are currently no standard methods for sample size estimation in metabolomics .
BACKGROUND	Since pilot studies are rarely done in metabolomics , currently existing sample size estimation approaches which rely on pilot data can not be applied .
RESULTS	In this article , an analysis based approach called MetSizeR is developed to estimate sample size for metabolomic experiments even when experimental pilot data are not available .
RESULTS	The key motivation for MetSizeR is that it considers the type of analysis the researcher intends to use for data analysis when estimating sample size .
RESULTS	MetSizeR uses information about the data analysis technique and prior expert knowledge of the metabolomic experiment to simulate pilot data from a statistical model .
RESULTS	Permutation based techniques are then applied to the simulated pilot data to estimate the required sample size .
CONCLUSIONS	The MetSizeR methodology , and a publicly available software package which implements the approach , are illustrated through real metabolomic applications .
CONCLUSIONS	Sample size estimates , informed by the intended statistical analysis technique , and the associated uncertainty are provided .

###25593485
OBJECTIVE	To assess the long-term effects of physical activity on irritable bowel syndrome ( IBS ) symptoms and on quality of life , fatigue , depression and anxiety .
METHODS	Seventy-six patients from a previous randomized controlled interventional study on increased physical activity in IBS were asked to participate in this long-term follow-up study .
METHODS	The included patients attended one visit in which they filled out questionnaires and they underwent a submaximal cycle ergometer test .
METHODS	The primary end point was the change in the IBS Severity Scoring System ( IBS-SSS ) at baseline , i.e. , before the intervention and at follow-up .
METHODS	The secondary endpoints were changes in quality of life , fatigue , depression and anxiety .
RESULTS	A total of 39 [ 32 women , median age 45 ( 28-61 ) years ] patients were included in this follow-up .
RESULTS	Median follow-up time was 5.2 ( range : 3.8-6 .2 ) years .
RESULTS	The IBS symptoms were improved compared with baseline [ IBS-SSS : 276 ( 169-360 ) vs 218 ( 82-328 ) , P = 0.001 ] .
RESULTS	This was also true for the majority of the dimensions of psychological symptoms such as disease specific quality of life , fatigue , depression and anxiety .
RESULTS	The reported time of physical activity during the week before the visit had increased from 3.2 ( 0.0-10 .0 ) h at baseline to 5.2 ( 0.0-15 .0 ) h at follow-up , P = 0.019 .
RESULTS	The most common activities reported were walking , aerobics and cycling .
RESULTS	There was no significant difference in the oxygen uptake 31.8 ( 19.7-45 .8 ) mL per min per kg at baseline vs 34.6 ( 19.0-54 .6 ) mL/min per kg at follow-up .
CONCLUSIONS	An intervention to increase physical activity has positive long-term effects on IBS symptoms and psychological symptoms .

###25728105
BACKGROUND	Streptococcus mutans is one of the most common cariogenic microorganisms .
BACKGROUND	Use of natural anticariogenic agents , such as Xylitol has been well-established in the literature .
BACKGROUND	On the other hand , there is a scarcity of studies that have reported the antimicrobial potential of Propolis as an anticariogenic chewing agent ; hence , the present study was designed .
OBJECTIVE	To evaluate and compare the anticariogenic action of two commercial chewing gums Propolis and Xylitol on the salivary S. mutans count in a group of children from Bengaluru city .
METHODS	Clinical setting and experimental design .
METHODS	Thirty healthy children aged 8-11 years with decayed , missing , and filled teeth ( dmft ) / DMFT index score3 were included in the study .
METHODS	Before the test , unstimulated saliva was collected .
METHODS	Children divided into Group I and II were given Propolis and Xylitol chewing gums respectively ; to chew for 15 min .
METHODS	Saliva samples were then collected at 15 min ( just after spitting ) and after 1 h.
METHODS	The amount of S. mutans in saliva was evaluated using a selective media ( MSAB ) .
METHODS	In addition , compliance of the two chewing gums among the children was tested with a questionnaire .
METHODS	Student 's t-test .
RESULTS	Six samples out of 30 were excluded due to no growth .
RESULTS	The total number of bacterial colonies was significantly reduced when compared to baseline in both the groups .
RESULTS	Propolis gum showed statistically significant reduction in the number of colonies as compared to Xylitol .
RESULTS	Xylitol gum was more preferred than Propolis gum by the children .
CONCLUSIONS	Propolis chewing gum can be used as an anticariogenic agent in children .

###24913212
OBJECTIVE	To evaluate the effect of a dance-based therapy on depressive symptoms among institutionalized older adults .
METHODS	Randomized controlled trial .
METHODS	Nursing homes .
METHODS	Older adults ( 60 years or older ) permanently living in a nursing home .
METHODS	Exercise Dance for Seniors ( EXDASE ) Program designed for the use in long-term care settings performed once a week for 60 minutes for 3 months .
METHODS	Baseline measures included sociodemographic characteristics , ability to perform basic as well as instrumental activities of daily living , basic mobility , self-rated health , and cognitive status .
METHODS	Outcome measures were collected before and after the intervention and included assessment of depressive symptoms using the geriatric depression scale ( GDS ) .
RESULTS	Comparison of participants with MMSE of 15 or higher showed that GDS scores in the intervention group significantly improved ( P = .005 ) , whereas the control group had a trend of further worsening of depressive symptoms ( P = .081 ) .
RESULTS	GLM analysis documented highly statistically significant effect of dance therapy ( P = .001 ) that was not influenced by controlling for intake of antidepressants and nursing home location .
RESULTS	Dance therapy may have decreased depressive symptoms even in participants with MMSE lower than 15 and resulted in more discontinuations and fewer prescriptions of antidepressants in the intervention group than in the control group .
CONCLUSIONS	This study provides evidence that dance-based exercise can reduce the amount of depressive symptoms in nursing home residents .
CONCLUSIONS	In general , this form of exercise seems to be very suitable and beneficial for this population .

###24737406
OBJECTIVE	This study aimed to investigate the efficacy of UPPP combined with an oral appliance ( OA ) in the treatment of obstructive sleep apnea-hypopnea syndrome ( OSAHS ) .
METHODS	Forty patients diagnosed with severe OSAHS were randomly divided into two groups : 20 patients in the pure surgery group treated by uvulopalatopharyngoplasty ( UPPP ) surgery and the remaining 20 patients in the combined treatment group for the combined application of UPPP and OA .
METHODS	Nocturnal PSG monitoring was performed in postoperative 0.5 and 3.0 a. AHI , SaO , and sleep structure improvement were calculated to compare the treatment efficiency of the two groups .
RESULTS	The AHI of the combined treatment group in the postoperative 3 was lower than that of the pure surgery group , whereas the lowest SaO value was higher than that of the pure surgery group ( P < 0.05 ) .
RESULTS	The sleep structure improvement of the combined treatment group in the postoperative 3a was possibly more normal than that of the pure surgery group .
CONCLUSIONS	The long-term efficacy of the combined UPPP and OA for the treatment of OSAHS was higher than that of pure UPPP treatment .

###24957530
OBJECTIVE	To describe specific causes of death and evaluate whether bleeding events and infection contributed to mortality in all ticagrelor-treated and clopidogrel-treated patients with acute coronary syndromes .
METHODS	In the PLATelet inhibition and patient Outcomes ( PLATO ) trial , ticagrelor significantly reduced rates of vascular and total death compared with clopidogrel .
METHODS	In the 905 patients who died postenrolment in the PLATO trial ( n = 18624 ) , reviewers , blinded to study treatment , subclassified direct causes of death and evaluated whether infection or bleeding events contributed to fatal events .
RESULTS	Among vascular deaths , there were significantly fewer sudden deaths ( 63 ( 0.7 % ) vs 98 ( 1.1 % ) , p < 0.01 ) but no significant difference in deaths caused by acute myocardial infarction ( 179 ( 1.9 % ) vs 194 ( 2.1 % ) , p = 0.43 ) or heart failure ( 31 ( 0.3 % ) vs 42 ( 0.5 % ) , p = 0.20 ) with ticagrelor compared with clopidogrel .
RESULTS	For non-vascular deaths , there was no difference between treatments in deaths directly caused by infection .
RESULTS	Although , patients treated with ticagrelor were at lower risk for death where infection was either a direct cause or contributed to death ( 51 ( 0.5 % ) vs 76 ( 0.8 % ) , HR 0.67 ( 0.47 to 0.95 ) , p < 0.05 ) but not for bleeding ( 42 ( 0.5 % ) vs 42 ( 0.5 % ) , HR 0.99 ( 0.65 to 1.53 ) , p = 0.98 ) .
CONCLUSIONS	In this post hoc analysis , ticagrelor compared with clopidogrel reduced total and cardiovascular mortality , which appeared to be mainly mediated by a reduction in sudden death .
CONCLUSIONS	Importantly , bleeding causing or contributing to death did not differ between treatments .
BACKGROUND	NCT00391872 ( http://www.clinicaltrial.gov ) .

###24957844
OBJECTIVE	Many studies have failed to show an effect of parent-supervised practice driving on the driving performance of teenagers ; nevertheless , most Graduated Driver Licensing programs have provisions that require supervised practice .
OBJECTIVE	To determine whether a web-based intervention , the Teen Driving Plan ( TDP ) , can improve the driving performance of teenagers before licensure as measured by the Teen On-road Driving Assessment ( tODA ) .
METHODS	Randomized , single-blind , clinical trial among 217 dyads ( 1 parent : 1 teenaged learner 's - permit holder ) to test TDP effectiveness on increasing the quantity and diversity of supervised practice and improving the teenagers ' prelicensed driving performance .
METHODS	The study was conducted from December 2011 through January 2013 in Southeastern Pennsylvania .
METHODS	Dyads were randomized ( 3:2 ) to receive the TDP or the Pennsylvania driver 's manual ( control group ) .
METHODS	The TDP is a psychoeducational intervention designed to increase the quantity and diversity of parent-supervised practice .
METHODS	Materials are grouped by the following driving environments : empty parking lots , suburban residential streets , intermediate ( 1 - or 2-lane ) roads , highways , rural roads with curves and elevation changes , and commercial districts .
METHODS	The main outcomes were self-reported practice driving across 6 environments and 2 conditions and driving performance as measured by the teenagers ' completion of the standardized and validated tODA 24 weeks after enrollment .
METHODS	Certified professional driving evaluators blinded to randomization status terminated the tODA if they determined that the teenager could not safely complete it .
METHODS	We examined mean differences in the quantity of supervised practice , differences in the overall proportion of teenagers in each group that had assessments terminated for unsafe driving , and the point of termination during the assessment .
RESULTS	The TDP dyads reported more practice in 5 of the 6 environments and at night and in bad weather compared with the control dyads .
RESULTS	Overall , 5 of 86 TDP teenagers ( 6 % ) had the tODA terminated compared with 10 of 65 control teenagers ( 15 % ) ( risk difference [ TDP-control ] , -9 % [ 95 % CI , -21 % to 2 % ] ; P = .06 ) .
RESULTS	The hazard ratio for exposure to TDP was 0.35 ( 95 % CI , 0.12-1 .03 ; P = .05 , log-rank test ) .
CONCLUSIONS	Preliminary evidence suggests that the TDP improves supervised practice and the driving performance of prelicensed teenaged drivers .
CONCLUSIONS	Future studies can explore how to revise the TDP to enhance the treatment effect and how best to disseminate the TDP without compromising implementation fidelity .
BACKGROUND	clinicaltrials.gov Identifier : NCT01498575 .

###25352865
BACKGROUND	Hypoglycemia is a major cause of morbidity and mortality among preterm infants and its management remains a challenge in resource limited settings .
BACKGROUND	Use of dextrose infusion by the recommended infusion pumps is not feasible in our environment due to their high costs and yet the current use of mini dextrose boluses with syringes as adapted at Mulago national referral and tertiary teaching hospital has unknown efficacy in prevention of hypoglycemia .
OBJECTIVE	We determined the efficacy of dextrose infusions by burettes versus two hourly dextrose boluses in prevention of hypoglycemia among preterms admitted in the first 72 hours at Special Care Unit , Mulago Hospital .
METHODS	One hundred and forty preterms aged 0 to 24 hours of life were randomized to receive 10 % IV dextrose either as mini boluses or by infusion using burettes in an open label clinical trial .
METHODS	Blood glucose was measured at 0 , two hourly for next 6 hours , 6 hourly for next 12 hours and thereafter 12 hourly until end of 72 hours following admission .
METHODS	Primary end point was incidence of hypoglycemia ( random blood sugar ( RBS ) < 2.6 mmol/l ) which was expressed as relative risk ( RR ) .
METHODS	Efficacy of the dextrose infusion was computed using 1-RR .
RESULTS	From February 2012 to April 2012 , 68 preterms in the bolus arm and 72 in the infusion arm were studied .
RESULTS	Hypoglycemia was detected in 34 % ( 48/140 ) .
RESULTS	The incidence of hypoglycemia in the bolus arm was 59 % ( 40/68 ) compared to 11 % ( 8/72 ) in the infusion arm ( RR ; 0.19 , 95 % CI ; 0.09-0 .37 ) .
RESULTS	Efficacy ( 1-RR ) of infusion by burettes versus boluses in prevention of hypoglycemia among preterms was 0.81 ( 95 % CI ; 0.63-0 .90 ) .
CONCLUSIONS	Continuous 10 % dextrose infusion by burettes reduced the incidence of hypoglycemia by 81 % in the first 72 hours of admission compared to two hourly 10 % mini dextrose boluses among preterms admitted at Special Care Unit , Mulago Hospital .
CONCLUSIONS	( ClinicalTrials.gov Identifier : NCT01688674 ) .

###25916088
OBJECTIVE	The aim of our study was to investigate the inhibitory effects on gastric acid secretion of a single oral dose of a proton pump inhibitor , esomeprazole 20 mg and omeprazole 20 mg .
METHODS	A total of 14 Helicobacter pylori-negative male subjects participated in this study .
METHODS	Intragastric pH was monitored continuously for 6 hours after a single oral dose of omeprazole 20 mg and a single oral dose of esomeprazole 20 mg .
METHODS	Each administration was separated by a 7-day washout period .
RESULTS	During the 6-hour study period , the average pH after administration of esomeprazole was higher than that after the administration of omeprazole .
RESULTS	Also during the 6-hour study period , each of pH > 2 , 3 , 3.5 , 4 , and 5 was maintained for a longer duration after administration of esomeprazole 20 mg than after administration of omeprazole 20 mg ( median : 75.4 % vs. 53.8 % , p = 0.0138 ; 52.1 % vs. 33.4 % , p = 0.0188 ; 45.8 % vs. 28.2 % , p = 0.0262 ; 42.5 % vs. 20.7 % , p = 0.0414 ; 35.8 % vs. 11.6 % , p = 0.0262 ; respectively ) .
CONCLUSIONS	In Helicobacter pylori-negative healthy male subjects , single oral administration of esomeprazole 20 mg increased the intragastric pH more rapidly than single oral administration of omeprazole 20 mg .

###24351886
OBJECTIVE	Procedural sedation by non-anaesthesiologists with GABAergic anaesthetics has the potential risk of fatal respiratory depression .
OBJECTIVE	Dexmedetomidine works its sedative action via 2-adrenergic receptors , and is less associated with respiratory depression .
OBJECTIVE	We tested the usability of dexmedetomidine as a procedural sedative during ablation of atrial fibrillation ( AF ) .
RESULTS	Consecutive patients were randomized to be treated with dexmedetomidine ( n = 43 ) or thiamylal ( n = 44 ) as sedatives during AF ablation .
RESULTS	Apnoeic and body movement events were monitored using a novel portable respiratory monitor , the SD-101 , during the procedure .
RESULTS	Although the majority of the patients receiving dexmedetomidine required rescue sedations with thiamylal , the respiratory disturbance index ( RDI ) defined as the total number of sleep-disordered breathing events divided by the recording time ( 10.4 5.1 vs. 18.2 8.1 events/h ; P < 0.0001 ) and movement index defined as the number of body movement events per hour ( 7.6 6.1 vs. 11.0 5.5 events/h ; P = 0.0098 ) were both significantly lower in the dexmedetomidine arm than in the thiamylal arm .
RESULTS	A multivariate linear regression analysis including potential factors revealed that dexmedetomidine vs. thiamylal was solely and independently associated with the RDI ( = -0.62 ; P = 0.0031 ) .
RESULTS	The occurrence of hypotension [ 9 ( 21 % ) vs. 4 ( 9 % ) ; P = 0.14 ] and bradycardia [ 4 ( 9 % ) vs. 4 ( 9 % ) ; P = 1.0 ] were similar in the patients with dexmedetomidine and thiamylal .
CONCLUSIONS	Procedural sedation with dexmedetomidine may assure safety and patient immobility during AF ablation , and therefore may be a potential alternative for that with GABAergic anaesthetics .

###25386778
OBJECTIVE	The goal of this study was to examine the longitudinal trajectories of posttraumatic stress disorder ( PTSD ) symptoms in a sample of acutely injured hospitalized civilian trauma survivors who participated in a randomized clinical trial .
OBJECTIVE	Prior longitudinal descriptive research has shown that there are distinct trajectories of PTSD symptoms over time in trauma survivors .
OBJECTIVE	Limited clinical trial research exists that describes the patterns of the trajectories as well as the risk factors that influence the trajectories for seriously injured trauma-exposed patients .
METHODS	Semiparametric , group-based approach trajectory modeling was used to examine four group trajectories of a subset of data obtained from a previous longitudinal clinical trial .
METHODS	Trajectories examined included resilience , recovery , relapsing/remitting , and chronic symptom patterns .
METHODS	One hundred and ninety-four patients who participated in the randomized clinical trial were assessed at baseline in the days and weeks after injury and then randomized .
METHODS	The associations between previously identified PTSD risk factors and the four trajectories were examined .
RESULTS	The risk factors of ethnocultural minority status , psychiatric history , additional life stressors , and depressive symptoms , as well as intervention versus control group status , were found to significantly affect the probability of trajectory group membership for PTSD symptom severity .
CONCLUSIONS	These findings suggest that there is a need for early PTSD interventions that anticipate differences in injured patients ' PTSD trajectory profiles .
CONCLUSIONS	Stepped care intervention procedures may optimally address the diverse PTSD trajectory patterns observed in injured trauma survivors through the tailoring of intervention timing and dosing .

###25113556
BACKGROUND	Postoperative pain control remains a major challenge for surgical procedures , including laparoscopic gastric bypass .
BACKGROUND	Pain management is particularly relevant in obese patients who experience a higher number of cardiovascular and pulmonary events .
BACKGROUND	Effective pain management may reduce their risk of serious postoperative complication , such as deep vein thrombosis and pulmonary emboli .
BACKGROUND	The objective of this study is to evaluate the efficacy of intraperitoneal local anaesthetic , ropivacaine , to reduce postoperative pain in patients undergoing laparoscopic Roux-en-Y gastric bypass .
METHODS	A randomised controlled trial will be conducted to compare intraperitoneal ropivacaine ( intervention ) versus normal saline ( placebo ) in 120 adult patients undergoing bariatric bypass surgery .
METHODS	Ropivacaine will be infused over the oesophageal hiatus and throughout the abdomen .
METHODS	Patients in the control arm will undergo the same treatment with normal saline .
METHODS	The primary end point will be postoperative pain at 1 , 2 and 4h postoperatively .
METHODS	Pain measurements will then occur every 4h for 24h and every 8h until discharge .
METHODS	Secondary end points will include opioid use , peak expiratory flow , 6min walk distance and quality of life assessed in the immediate postoperative period .
METHODS	Intention-to-treat analysis will be used and repeated measures will be analysed using mixed modelling approach .
METHODS	Post-hoc pairwise comparison of the treatment groups at different time points will be carried out using multiple comparisons with adjustment to the type 1 error .
METHODS	Results of the study will inform the feasibility of recruitment and inform sample size of a larger definitive randomised trial to evaluate the effectiveness of intraperitoneal ropivacaine .
BACKGROUND	This study has been approved by the Ottawa Health Science Network Research Ethics Board and Health Canada in April 2014 .
BACKGROUND	The findings of the study will be disseminated through national and international conferences and peer-reviewed journals .
BACKGROUND	Clinicaltrial.gov NCT02154763 .

###25348858
OBJECTIVE	Mild therapeutic hypothermia ( TH ) is recommended as soon as possible after the return of spontaneous circulation to improve outcomes after out-of-hospital cardiac arrest ( OHCA ) .
OBJECTIVE	Preclinical data suggest that the benefit of TH could be increased if treatment is started during cardiac arrest .
OBJECTIVE	We aimed to study the impact of intra-arrest therapeutic hypothermia ( IATH ) on neurological injury and inflammation following OHCA .
METHODS	We conducted a 1:1 randomized , multicenter study in three prehospital emergency medical services and four critical care units in France .
METHODS	OHCA patients , irrespective of the initial rhythm , received either an infusion of cold saline and external cooling during cardiac arrest ( IATH group ) or TH started after hospital admission ( hospital-cooling group ) .
METHODS	The primary endpoint was neuron-specific enolase ( NSE ) serum concentrations at 24 h. Secondary endpoints included IL-6 , IL-8 , and IL-10 concentrations , and clinical outcome .
RESULTS	Of the 245 patients included , 123 were analyzed in the IATH group and 122 in the hospital-cooling group .
RESULTS	IATH decreased time to reach temperature 34 C by 75 min ( 95 % CI : 4 ; 269 ) .
RESULTS	The rate of patients admitted alive to hospital was not different between groups [ IATH n = 41 ( 33 % ) vs. hospital cooling n = 36 ( 30 % ) ; p = 0.51 ] .
RESULTS	Levels of NSE and inflammatory biomarkers were not different between groups [ median NSE at 24 h : IATH 96.7 g/l ( IQR : 49.9-142 .8 ) vs. hospital cooling 97.6 g/l ( IQR : 74.3-142 .4 ) , p = 0.64 ] .
RESULTS	No difference in survival and cerebral performance were found at 1 month .
CONCLUSIONS	IATH did not affect biological markers of inflammation or brain damage or clinical outcome .

###24682465
BACKGROUND	Standard first-line chemotherapy for elderly non-small cell lung cancer ( NSCLC ) patients has been monotherapy with vinorelbine or gemcitabine .
BACKGROUND	Docetaxel has also been considered as an alternative option for the elderly population in Japan .
BACKGROUND	We have previously demonstrated the high efficacy of carboplatin plus weekly paclitaxel for elderly NSCLC patients .
BACKGROUND	Consequently , we conducted a randomized phase II study to select the proper regimen for a future phase III trial .
METHODS	Eligible patients were aged 70 years or older with newly diagnosed advanced NSCLC .
METHODS	Patients were randomly assigned either to a combination of carboplatin ( area under the curve : 6 mg/mL per minute ) with weekly paclitaxel ( 70 mg/m ) ( CP regimen ) or to single-agent docetaxel ( 60 mg/m ) .
METHODS	The primary endpoint of this study was objective response rate .
METHODS	Secondary endpoints were progression-free survival , overall survival , and toxicity profile .
RESULTS	Among 83 eligible patients ( 41 to CP , 42 to docetaxel ) , the objective response rates were 54 % ( 95 % confidence interval : 39 % -69 % ) and 24 % ( 95 % confidence interval : 11 % -37 % ) and median progression-free survival was 6.6 months and 3.5 months in the CP arm and the docetaxel arm , respectively .
RESULTS	Severe neutropenia , febrile neutropenia , and nausea were significantly frequent in the docetaxel arm , whereas toxicities in the CP arm were generally moderate .
RESULTS	One treatment-related death was observed in the docetaxel arm .
CONCLUSIONS	The CP regimen achieved higher activity with less toxicity than single-agent docetaxel .
CONCLUSIONS	Considering the results of this phase II trial and the IFCT-0501 trial , we have selected the CP regimen for a future phase III trial in elderly patients with advanced NSCLC .

###24766746
BACKGROUND	Field vaccination trials with Mycobacterium bovis BCG , an attenuated mutant of M. bovis , are ongoing in Spain , where the Eurasian wild boar ( Sus scrofa ) is regarded as the main driver of animal tuberculosis ( TB ) .
BACKGROUND	The oral baiting strategy consists in deploying vaccine baits twice each summer , in order to gain access to a high proportion of wild boar piglets .
BACKGROUND	The aim of this study was to assess the response of wild boar to re-vaccination with BCG and to subsequent challenge with an M. bovis field strain .
RESULTS	BCG re-vaccinated wild boar showed reductions of 75.8 % in lesion score and 66.9 % in culture score , as compared to unvaccinated controls .
RESULTS	Only one of nine vaccinated wild boar had a culture-confirmed lung infection , as compared to seven of eight controls .
RESULTS	Serum antibody levels were highly variable and did not differ significantly between BCG re-vaccinated wild boar and controls .
RESULTS	Gamma IFN levels differed significantly between BCG re-vaccinated wild boar and controls .
RESULTS	The mRNA levels for IL-1b , C3 and MUT were significantly higher in vaccinated wild boar when compared to controls after vaccination and decreased after mycobacterial challenge .
CONCLUSIONS	Oral re-vaccination of wild boar with BCG yields a strong protective response against challenge with a field strain .
CONCLUSIONS	Moreover , re-vaccination of wild boar with BCG is not counterproductive .
CONCLUSIONS	These findings are relevant given that re-vaccination is likely to happen under real ( field ) conditions .

###25596571
BACKGROUND	In this study , we examined the effects of Brucella infection on endothelial dysfunction .
BACKGROUND	Flow-mediated dilatation ( FMD ) measurement is indicator of the endothelial function , and abnormal values indicating endothelial dysfunction are accepted as the first stage of atherosclerosis .
METHODS	Twenty-four patients who had been treated for acute brucellosis two years before , and who had had no relapses in the follow-up , were prospectively included in the study , along with 30 healthy individuals in the control group .
RESULTS	While the highly sensitive C-reactive protein ( hs-CRP ) value was 2.42 1.45 in the patient group , it was 1.72 0.61 in the control group ( p = 0.025 ) .
RESULTS	While the FMD value was 3.50 1.58 in the patient group , it was 5.88 1.88 in the control group ( p < 0.001 ) .
RESULTS	While the percentage increase in FMD was 9.88 4.92 in the patient group , it was 17.49 6.3 in the control group ( p < 0.001 ) .
RESULTS	It was observed that FMD value , the percentage increase in FMD , and basal radius were correlated with hs-CRP ( r = -0.644 , p < 0.001 ; r = - 0.558 , p = 0.002 ; r = 0.444 , p = 0.018 , respectively ) .
RESULTS	The carotid artery intima media thickness ( IMT ) value was found to be 0.61 0.17 in the patient group and 0.49 0.12 in the control group ( p = 0.004 ) .
CONCLUSIONS	The abnormal FMD and IMT values observed in brucellosis patients might be an indicator of more frequent arterial dysfunction , increased cardiovascular risk , and atherosclerosis .

###25955226
BACKGROUND	Undercarboxylated osteocalcin ( ucOC ) has been shown to affect glucose metabolism in mice .
BACKGROUND	We recently randomized patients with hypoparathyroidism to treatment with PTH or placebo and demonstrated a marked increase in total osteocalcin .
OBJECTIVE	To investigate whether there was a similar increase in ucOC and whether that increase affected glucose metabolism .
METHODS	A 24-week randomized , placebo-controlled trial .
METHODS	Ambulatory patients in a research facility .
METHODS	Sixty-two patients aged 31-78 years with hypoparathyroidism , of which 58 completed the trial .
METHODS	100 g/d of PTH ( 1-84 ) .
METHODS	Change in ucOC .
RESULTS	ucOC increased by 1185.0 814.4 % ( mean SD ) in the PTH-treated group and by 69.3 79.4 % in the placebo group ( P < 10 ( -50 ) ) .
RESULTS	In addition , body weight decreased by 1.1 4.0 % in the treatment group and increased 0.8 2.5 % in the placebo group ( P = .04 ) .
RESULTS	Glucose , adiponectin , leptin , homeostasis model of assessment for insulin resistance , total body fat mass , or truncal fat did not change significantly .
RESULTS	In addition , the number of hypercalcemic episodes per patient was 3.7 2.9 ( mean SD ) in the PTH-treated group but only 0.2 0.6 in the placebo group ( P < .001 ) .
RESULTS	Moreover , there was a significant and negative correlation between the change in ucOC and change in body weight ( P = .004 ) or change in total body fat mass ( P = .03 ) , and a negative but nonsignificant correlation between the number of hypercalcemic episodes and percentage change in body weight ( r = -0.32 ; P = .1 ) .
RESULTS	Change in ucOC did not significantly correlate with changes in other parameters .
CONCLUSIONS	An explanation for the weight loss may be subtle hypercalcemia in PTH treatment inhibiting appetite .
CONCLUSIONS	Our data do not support a role for ucOC in energy metabolism in humans .

###24219852
OBJECTIVE	Despite the benefits of endoscopic nasobiliary drainage ( NBD ) in endoscopic retrograde cholangiopancreatography ( ERCP ) , post-ERCP pancreatitis ( PEP ) and nose/throat discomfort can result .
OBJECTIVE	We aimed to determine whether the use of a smaller catheter alleviates these complications .
METHODS	A randomized , controlled trial at a tertiary care center compared 4 Fr and 6 Fr NBD catheters ; 165 ERCP patients with nave papillae were randomly assigned to a catheter-size group .
RESULTS	The prevalence of PEP was significantly lower in the 4 Fr group ( 3.7 % ; 3/82 ) than in the 6 Fr group ( 15.7 % ; 13/83 ; P = 0.019 ) .
RESULTS	No spontaneous catheter displacement occurred within 24h .
RESULTS	Discomfort visual analog scores were 2.6 and 4.3 in the 4 Fr and 6 Fr groups , respectively ( P = 0.0048 ) on procedure day ; on the following day , the scores were 2.3 and 3.6 ( P = 0.028 ) .
RESULTS	Bile output was 16.3 mL/h and 21.4 mL/h in the 4 Fr and 6 Fr groups ( P = 0.051 ) .
RESULTS	On obstructive jaundice subgroup analysis , bile drainage was 19.2 mL/h and 22.1 mL/h in the 4 Fr and 6 Fr groups ( P = 0.40 ) .
RESULTS	The 4 Fr group required 5.6 days to reduce bilirubin levels versus 6.1 days in the 6 Fr group ( P = 0.51 ) .
CONCLUSIONS	In patients with nave papillae , lower rates of PEP and less nose/throat discomfort are associated with the use of 4 Fr NBD catheters .
CONCLUSIONS	In patients with obstructive jaundice , 4 Fr and 6 Fr catheters are comparable with regard to bile output and bilirubin level reduction .

###24429539
BACKGROUND	Telephone-based interventions can be effective in increasing child fruit and vegetable intake in the short term ( < 6 mo ) .
BACKGROUND	The long-term efficacy of such interventions , however , is unknown .
OBJECTIVE	The primary aim of this study was to determine whether the short-term ( < 6 mo ) impact of a telephone-based intervention on children 's fruit and vegetable intake was sustained over a longer term .
OBJECTIVE	A secondary aim of the study was to assess the long-term impact of the intervention on the intake of foods high in fat , salt , or sugar ( noncore foods ) .
METHODS	The study used a cluster randomized controlled trial design .
METHODS	Parents were recruited from Australian preschools between February and August 2010 and allocated to receive an intervention consisting of print materials and 4 telephone-counseling calls delivered over 1 mo or to a print information-only control group .
METHODS	The primary endpoint for the trial was the 18-mo postbaseline follow-up .
METHODS	Linear regression models were used to assess between-group differences in child consumption of fruit and vegetables and noncore foods by subscales of the Children 's Dietary Questionnaire .
RESULTS	Fruit and vegetable subscale scores were significantly higher , indicating greater child fruit and vegetable intake , among children in the intervention group at the 12-mo ( 16.77 compared with 14.89 ; P < 0.01 ) but not the 18-mo ( 15.98 compared with 16.82 ; P = 0.14 ) follow-up .
RESULTS	There were no significant differences between groups at either of the follow-up periods in the noncore food subscale score .
CONCLUSIONS	Further research to identify effective maintenance strategies is required to maximize the benefits of telephone-based interventions on child diet .

###24478190
OBJECTIVE	To assess and compare the intra-arterial injection-associated discomfort of iodinated contrast media ( CM ) and the impact on diagnostic efficacy in diabetics with critical limb ischemia ( CLI ) .
BACKGROUND	Arterial revascularization is a mainstay in patients with CLI .
BACKGROUND	Previous diagnostic angiography is a crucial step that can be affected by CM injection discomfort compromising the revascularization results , and it could vary related to the CM agents .
METHODS	One hundred forty-eight patients received Iodixanol 270 mg iodine pro ml or Ioversol 320 mg iodine pro ml in a prospective , double-blind , randomized , parallel-group clinical trial .
METHODS	Injection-associated discomfort was assessed by Visual Analogic Scale ( VAS ) .
METHODS	Diagnostic efficacy and safety up to 1 week were evaluated .
RESULTS	The incidence of pain has been around 50 % of the all population in study , with lesser incidence of pain ( 25.7 % vs 74.3 % ; P < 0.0001 ) and of heat sensation ( 55.4 % vs 85.1 % ; P < 0.0001 ) , after Iodixanol than after Ioversol injection .
RESULTS	Discomfort mean score , according to VAS assessment , was less in the Iodixanol group ( 8.115.3 ) than in the Ioversol group ( 36.029.7 ) , after first injection ( P < 0.001 ) and for all injections ( P < 0.001 ) .
RESULTS	A significant difference was also observed in favor of Iodixanol ( P < 0.001 ) , respect to mean score of discomfort and heat sensation , assessed by the operators after all the CM injections .
CONCLUSIONS	Iodixanol caused less frequent and severe discomfort , characterized as pain and heat during intra-arterial administration compared with Ioversol .
CONCLUSIONS	The pain severity is tightly related to image and diagnosis quality with an impact on the patients for additional injections and larger CM volumes .

###25840525
BACKGROUND	Barbed sutures have unidirectional circumferential shallow barbs , which distribute tension throughout the wound and close wound securely without the need to tie knots .
OBJECTIVE	We compare two different methods of wound closure in elective plastic surgical cases : barbed 3/0V-Loc 180 suture and smooth 3/0Maxon sutures , both polyglyconate monofilament synthetic absorbable sutures .
OBJECTIVE	We assessed the aesthetic long-term results with a minimum two year follow up .
METHODS	This is a prospective , randomized controlled study with internal control .
METHODS	A single surgeon performed all cases .
METHODS	Patients who underwent elective operations that involved long wound closure were enrolled in the study .
METHODS	Each patient acted as their own internal control with half their wound being sutured with 3/0V-Loc 180 barbed suture and the other half with smooth 3/0Maxon deep dermal sutures and then a subcuticular skin closure .
METHODS	In both groups , the superficial fascial system was closed with 1 Vicryl interrupted sutures on both sides .
METHODS	Long-term cosmesis was evaluated using the modified Hollander cosmesis score by review of standardized postoperative photographs by 9 blinded plastic surgeons and specialist registrars .
RESULTS	The study reports on 33 female patients .
RESULTS	The time taken for wound closure was significantly reduced using the barbed suture ( p < 0.001 ) .
RESULTS	There was no difference in the complication ratio in either group .
RESULTS	Two-year aesthetic outcome was significantly superior when using the barbed suture ( p = 0.0075 ) .
CONCLUSIONS	Barbed sutures closure of long wounds is faster and produces a better long-term aesthetic outcome than smooth sutures .

###24598293
OBJECTIVE	To investigate the effects of Sini decoction on function of hypothalamic-pituitary-adrenal axis in patients with sepsis .
METHODS	A prospective single-blind randomized controlled trial was conducted .
METHODS	60 septic patients were divided into three groups with the method of random number table , 20 cases in the control group , 20 in the Chinese herb group , and 20 in corticoid group .
METHODS	All of them received routine treatment .
METHODS	Patients in Chinese herb group were given Sini decoction in addition ( decoction of monkshood 15 g , dried ginger 15 g , honey-fried licorice 10 g ) 100 mL/d orally or by nasal feeding , while patients in corticoid group were given hydrocortisone 200 mg/d intravenously instead , both for 7 days .
METHODS	Before the treatment , 3 days and 14 days after treatment , blood was collected to determine the levels of adrenocorticotropic hormone ( ACTH ) and cortisol , and the result of ACTH stimulating test was observed .
METHODS	At the same time , acute physiology and chronic health evaluation II ( APACHEII ) score was recorded , and 3-day shock recovery rate and 28-day death rate were also compared among these groups .
RESULTS	None of the three groups showed different result in ACTH stimulating test ( ( 2 ) = 1.101 , P = 0.605 ) .
RESULTS	ACTH in three groups was gradually decreased .
RESULTS	Compared with that before treatment , ACTH in Chinese herb group and corticoid groups began to decrease obviously on day 3 ( 29.903.31 ng/L vs. 33.103.31 ng/L , 28.202.45 ng/L vs. 33.303.84 ng/L , both P < 0.01 ) , while in control group declined ACTH appeared later ( on day 14 ) compared with before treatment ( 29.405.63 ng/L vs. 33.504.89 ng/L , P < 0.05 ) .
RESULTS	No obvious difference in ACTH level was showed between the Chinese herb group and the cortical group ( both P > 0.05 ) .
RESULTS	Cortisol level in both Chinese herb and cortical groups showed a raise-fall biphase trend while there was no change in the control .
RESULTS	The cortical levels on day 3 in Chinese herb and cortical groups were much higher than that before treatment ( 343.0431.20 g/L vs. 294.7042.10 g/L , 331.2542.80 g/L vs. 280.3638.10 g/L , both P < 0.01 ) and that of control group ( 291.6141.50 g/L , both P < 0.01 ) , though no significant statistical difference was observed between two groups ( both P > 0.05 ) .
RESULTS	APACHEII score on day 14 in control , Chinese herb and cortical groups was significantly lower than that before treatment ( 16.85.1 vs. 20.14.3 , 13.43.2 vs. 18.33.8,15.12.5 vs. 19.54.0 , all P < 0.01 ) , and the score was much lower in Chinese herb group comparing with that of control group ( P < 0.05 ) .
RESULTS	No statistical difference was observed among control , Chinese herb and cortical groups in lowering 28-day death rate [ 35.0 % ( 7/20 ) , 25.0 % ( 5/20 ) , 20.0 % ( 4/20 ) ] and improving 3-day shock recovery rate [ 40.0 % ( 8/20 ) , 70.0 % ( 14/20 ) , 60.0 % ( 12/20 ) , all P > 0.05 ] .
CONCLUSIONS	Sini decoction could elevate cortisol while lower ACTH at the early stage of sepsis .
CONCLUSIONS	Sini decoction could also effectively improve symptoms and hypothalamic-pituitary-adrenal axis function in septic patients without affecting death rate .

###24473153
OBJECTIVE	To investigate the efficacy of pregabalin for the relief of postoperative shoulder pain after laparoscopic gynecologic surgery .
METHODS	Prospective , randomized , double-blind , placebo-controlled trial ( Canadian Task Force classification I ) .
METHODS	Tertiary referral center , university hospital .
METHODS	Fifty-six women undergoing elective laparoscopic gynecologic surgery between June 2012 and March 2013 .
METHODS	Women in the study group received 75 mg pregabalin 2 hours before surgery and then every 12 hours for 2 doses , and women in the control group received an identical capsule and the same dosage of placebo .
RESULTS	Visual analog scale ( VAS ) scores for shoulder pain and surgical pain at 24 and 48 hours after surgery were evaluated as primary outcome .
RESULTS	Postoperative analgesics used and drug-related adverse events were also monitored .
RESULTS	Patients in the pregabalin group had significantly lower postoperative VAS scores for shoulder pain at 24 hours , compared with the placebo group ( median , 23.14 [ range , 13.67-32 .61 ] vs. 37.22 [ 27.75-46 .64 ] ; p = .04 ) , and required less analgesic ( p = .01 ) .
RESULTS	There were no significant differences in VAS scores for surgical pain and adverse events between the 2 groups ( p = .56 ) .
CONCLUSIONS	Perioperative administration of 75 mg pregabalin significantly reduced postoperative laparoscopic shoulder pain and amount of analgesic used .

###25614898
OBJECTIVE	With technological advances in NICUs the survival rate of preterm infants has been increased .
OBJECTIVE	Because NICU environment is a potent source of stress for infants , its modification is an essential measure to decrease infants ' morbidity .
OBJECTIVE	The purposes of this study were to compare the effects of wearing earmuff and provision silence for infants on their motor responses and gaining weight .
METHODS	In a randomized clinical trial 96 preterm infants were enrolled .
METHODS	Their motor responses were evaluated for two consecutive days in the morning and afternoon shifts , in the groups of earmuff and silence , and at similar time points in the control group .
METHODS	Also their weight was measured at days 1 and 10 .
RESULTS	In the two intervention groups , means of motor responses in infants were significantly less than in the control group , and weight gain of infants was more than the control group .
RESULTS	However weight gain was more pronounced in the earmuff group .
CONCLUSIONS	Both interventions led to decreasing number of motor responses and improvement of weight gain pattern , but these effects were more pronounced in earmuff group ; thus because implementation of silence in NICUs has many barriers , it is suggested to use earmuff for preterm infants in these units .
CONCLUSIONS	This trial obtained IRCT registration number IRCT2012092010812N2 .

###24606865
BACKGROUND	Unlike free pneumococcal polysaccharide vaccines ( PPSVs ) , pneumococcal conjugate vaccines ( PCVs ) induce a T-cell-dependent immune response .
BACKGROUND	The study assessed potential influence of initial 13-valent PCV ( PCV13 ) or 23-valent PPSV ( PPSV23 ) on subsequent vaccine administrations .
METHODS	We conducted a randomized , modified double-blind study in 720 pneumococcal vaccine-nave adults 60-64 years of age .
METHODS	Subjects received either PCV13 at year 0 and PCV13 at year 1 ; PCV13 at year 0 and PPSV23 at year 1 ; or PPSV23 at year 0 and PCV13 at year 1 .
METHODS	Antipneumococcal opsonophagocytic activity ( OPA ) titers were measured before and 1 month after each vaccination .
RESULTS	OPA titers following PPSV23 given 1 year after PCV13 ( PCV13/PPSV23 ) ( a ) were noninferior for the 12 common serotypes and significantly higher for 6 of 12 common serotypes than those following only an initial PPSV23 ; and ( b ) were significantly higher for 11 of 12 common serotypes compared with PPSV23 followed by PCV13 ( PPSV23/PCV13 ) .
RESULTS	In addition , PPSV23 followed 1 year later by PCV13 ( PPSV23/PCV13 ) elicited significantly lower OPA titers than after only an initial dose of PCV13 for all 13 serotypes .
RESULTS	Responses after a second vaccination with either PCV13 ( PCV13/PCV13 ) or PPSV23 ( PCV13/PPSV23 ) were noninferior for 9 of 13 and 8 of 12 common serotypes compared with the initial PCV13 dose .
CONCLUSIONS	In pneumococcal vaccine-nave adults 60-64 years of age , an initial PCV13 augmented the antipneumococcal response to subsequent administration of PPSV23 for many of the serotypes in common to both vaccines .
CONCLUSIONS	In contrast , an initial PPSV23 resulted in a diminished response to subsequent administration of PCV13 for all serotypes .
CONCLUSIONS	With a relatively short 1-year interval between doses , responses after a second vaccination with PCV13 ( PCV13/PCV13 ) or PPSV23 ( PCV13/PPSV23 ) were noninferior for a majority of serotypes compared with the initial PCV13 dose , probably reflecting the need for a longer interval between vaccine administrations .
CONCLUSIONS	ClinicalTrials.gov Identifier : NCT00574548 .

###25356603
BACKGROUND	Nilotinib and dasatinib have shown superior rates of molecular response ( MR ) compared to imatinib for the treatment of newly diagnosed chronic myeloid leukemia ( CML ) in chronic phase ( CP ) .
BACKGROUND	This study indirectly compares MR in patients taking nilotinib 300mg bid with that in those taking dasatinib 100mg qd by 12 months and through 48 months .
METHODS	Patients in ENESTnd were re-weighted to match published baseline characteristics reported for DASISION using a propensity score model .
METHODS	After matching , differences in rates of major MR ( MMR , measured as a 3log reduction on the International Scale [ IS ] ) , MR ( 4.0 ) ( 4log reduction on IS ) , and MR ( 4.5 ) ( 4.5 log reduction on IS ) relative to imatinib were indirectly compared between nilotinib and dasatinib .
METHODS	Hazard ratios ( HRs ) were used to indirectly compare MR outcomes between nilotinib and dasatinib through 48 months of follow-up , while rate differences were used to compare progression to AP/BC between nilotinib and dasatinib by 48 months .
RESULTS	After matching , rates of MR by 12 months were higher with nilotinib vs dasatinib by 11.7 % for MMR ( p = 0.045 ) , 8.2 % for MR ( 4.0 ) ( p = 0.029 ) , and 8.5 % for MR ( 4.5 ) ( p < 0.001 ) .
RESULTS	Higher rates of MMR ( HR = 1.44 , p = 0.018 ) and MR ( 4.0 ) ( HR = 1.58 , p = 0.013 ) achievement were maintained with nilotinib compared to dasatinib through 48 months of follow-up .
RESULTS	No statistically significant differences were observed for MR ( 4.5 ) through 48 months or progression to AP/BC by 48 months .
CONCLUSIONS	LIMITATIONS include comparisons based solely on indirect evidence and HRs for MR ( 4.0 ) and MR ( 4.5 ) from the DASISION trial being extracted from cumulative incidence curves .
CONCLUSIONS	This indirect comparison suggests that nilotinib is associated with higher rates of achieving MMR , MR ( 4.0 ) , and MR ( 4.5 ) by 12 months compared to dasatinib for the treatment of newly diagnosed CML-CP .
CONCLUSIONS	In addition , higher rates of MR achievement with nilotinib were also maintained through 48 months of follow-up .

###24898574
BACKGROUND	Motor cortex excitability was found to be changed after repetitive transcranial magnetic stimulation ( rTMS ) of the temporal cortex highlighting the occurrence of cross-modal plasticity in non-invasive brain stimulation .
BACKGROUND	Here , we investigated the effects of temporal low-frequency rTMS on motor cortex plasticity in a large sample of tinnitus patients .
BACKGROUND	In 116 patients with chronic tinnitus different parameters of cortical excitability were assessed before and after ten rTMS treatment sessions .
BACKGROUND	Patients received one of three different protocols all including 1 Hz rTMS over the left temporal cortex .
BACKGROUND	Treatment response was defined as improvement by at least five points in the tinnitus questionnaire ( TQ ) .
BACKGROUND	Variables of interest were resting motor threshold ( RMT ) , short-interval intra-cortical inhibition ( SICI ) , intracortical facilitation ( ICF ) , and cortical silent period ( CSP ) .
RESULTS	After rTMS treatment RMT was decreased by about 1 % of stimulator output near-significantly in the whole group of patients .
RESULTS	SICI was associated with significant changes with respect to treatment response .
RESULTS	The group of treatment responders showed a decrease of SICI over the course of treatment , the group of non-responders the reverse pattern .
CONCLUSIONS	Minor RMT changes during rTMS treatment do not necessarily suggest the need for systematic re-examination of the RMT for safety and efficacy issues .
CONCLUSIONS	Treatment response to rTMS was shown to be related to changes in SICI that might reflect modulation of GABAergic mechanisms directly or indirectly related to rTMS treatment effects .

###24712378
BACKGROUND	Fibre intake among North Americans is currently less than half the recommended amount .
BACKGROUND	Consumers are interested in food products that could promote weight loss and improve health .
BACKGROUND	Consequently , evaluation of unique fibre sources with potential gut-mediated benefits for metabolic health warrants investigation .
BACKGROUND	Our objective is to assess the effects of yellow pea fibre supplementation on weight loss and gut microbiota in an overweight and obese adult population .
METHODS	In a double blind , placebo controlled , parallel group study , overweight and obese ( BMI = 25-38 ) adults will be randomized to either a 15 g/d yellow pea fibre supplemented group or isocaloric placebo group for 12 weeks ( n = 30/group ) .
METHODS	The primary outcome measure is a change in body fat from baseline to 12 weeks .
METHODS	Secondary outcomes include glucose tolerance , appetite regulation , serum lipids and inflammatory markers .
METHODS	Anthropometric data ( height , weight , BMI , and waist circumference ) and food intake ( by 3-day weighed food records ) will be measured at baseline and every 4 weeks thereafter .
METHODS	Subjective ratings of appetite will be recorded by participants at home on a weekly basis using validated visual analogue scales .
METHODS	At week 0 and at the end of the study ( week 12 ) , an ad libitum lunch buffet protocol for objective food intake measures and dual-energy X-ray absorptiometry ( DXA ) scan for body composition will be completed .
METHODS	Participants will be instructed not to change their exercise habits during the 12 week study .
METHODS	Glucose and insulin will be measured during an oral glucose tolerance test at weeks 0 and 12 .
METHODS	Levels of lipids and CRP will be measured and inflammatory markers ( adiponectin , leptin , TNF - , IL-6 and IL-8 ) in the serum will be quantified using Milliplex kits .
METHODS	Mechanisms related to changes in gut microbiota , serum and fecal water metabolomics will be assessed .
CONCLUSIONS	Globally the development of functional foods and functional food ingredients are critically needed to curb the rise in metabolic disease .
CONCLUSIONS	This project will assess the potential of yellow pea fibre to improve weight control via gut-mediated changes in metabolic health in overweight and obese adults .
BACKGROUND	ClinicalTrials.gov ( NCT01719900 ) Registered October 23 , 2012 .

###24641687
OBJECTIVE	The effect of oral anxiolytics in diminishing patient discomfort and pain perception has been demonstrated in GI endoscopy , percutaneous coronary interventions , and various procedures in the emergency department setting , but has not been prospectively studied in the setting of prostate biopsy .
OBJECTIVE	The purpose of this study was to investigate the effect of diazepam on pain perception during and after prostate biopsy .
METHODS	Sixty patients undergoing prostate biopsy at a single academic institution were enrolled into a prospective , randomized , placebo-controlled study .
METHODS	A questionnaire was administered prebiopsy to determine baseline discomfort and pain history .
METHODS	A visual analog pain scale was used to determine pain associated with each step of the transrectal Ultrasonography-guided prostate biopsy and was administered 20 minutes after biopsy and 1 week later .
METHODS	Responses were compared between groups using the Mann-Whitney U test , Fisher exact test , and Wilcoxon signed rank test as appropriate .
RESULTS	A total of 60 patients ( 29 diazepam , 31 placebo ) completed pre - and postbiopsy surveys for analysis .
RESULTS	The number of cores sampled during biopsy was controlled during analysis and was found to have no correlation with total pain measured .
RESULTS	There were no differences between diazepam and placebo groups in age , prebiopsy survey results , immediate and 1 week postbiopsy survey results .
RESULTS	There was no difference in the patients ' willingness to undergo a repeated procedure in the control and treatment groups .
RESULTS	Complications of taking diazepam prebiopsy included drowsiness , chills , and ankle injury .
CONCLUSIONS	Diazepam does not improve patient pain perception immediately after or at 1-week recall after prostate biopsy .
CONCLUSIONS	Omitting diazepam simplifies the biopsy regimen and allows the patient to drive himself home .
CONCLUSIONS	Based on these results , routine use of diazepam in prostate biopsy is not recommended .

###25499162
BACKGROUND	External trigeminal nerve stimulation ( eTNS ) is an emerging noninvasive therapy for drug-resistant epilepsy ( DRE ) .
BACKGROUND	We report the long-term safety and efficacy of eTNS after completion of a phase II randomized controlled clinical trial for drug-resistant epilepsy .
METHODS	This was a prospective open-label long-term study .
METHODS	Subjects who completed the phase II randomized controlled trial of eTNS for DRE were offered long-term follow-up for 1year .
METHODS	Subjects who were originally randomized to control settings were crossed over to effective device parameters ( 30s on , 30s off , pulse duration of 250s , frequency of 120Hz ) .
METHODS	Efficacy was assessed using last observation carried forward or parametric imputation methods for missing data points .
METHODS	Outcomes included change in median seizure frequency , RRATIO , and 50 % responder rate .
RESULTS	Thirty-five of 50 subjects from the acute double-blind randomized controlled study continued in the long-term study .
RESULTS	External trigeminal nerve stimulation was well tolerated .
RESULTS	No serious device-related adverse events occurred through 12months of long-term treatment .
RESULTS	At six and twelve months , the median seizure frequency for the original treatment group decreased by -2.39 seizures per month at 6 months ( -27.4 % ) and -3.03 seizures per month at 12 months ( -34.8 % ) , respectively , from the initial baseline ( p < 0.05 , signed-rank test ) .
RESULTS	The 50 % responder rates at three , six , and twelve months were 36.8 % for the treatment group and 30.6 % for all subjects .
CONCLUSIONS	The results provide long-term evidence that external trigeminal nerve stimulation is a safe and promising long-term treatment for drug-resistant epilepsy .

###24555998
OBJECTIVE	The antiviral efficacy of nucleos ( t ) ide analogues whose main limitation is relapse after discontinuation requires long-term therapy .
OBJECTIVE	To overcome the risk of relapse and virological breakthrough during long-term therapy , we performed a phase I/II , open , prospective , multicentre trial using a HBV envelope-expressing DNA vaccine .
METHODS	70 patients treated effectively with nucleos ( t ) ide analogues for a median of 3years ( HBV DNA < 12IU/mL for at least 12months ) were randomised into two groups : one received five intramuscular injections of vaccine ( weeks 0 , 8 , 16 , 40 and 44 ) and one did not receive the vaccine .
METHODS	Analogues were stopped after an additional 48weeks of treatment in patients who maintained HBV DNA < 12IU/mL with no clinical progression and monthly HBV DNA for 6months .
METHODS	The primary endpoint was defined as viral reactivation at week 72 ( HBV DNA > 120IU/mL ) or impossibility of stopping treatment at week 48 .
RESULTS	Reactivation occurred in 97 % of each group after a median 28days without liver failure but with an HBV DNA < 2000IU/mL in 33 % ; 99 % of adverse reactions were mild to moderate .
RESULTS	Immune responses were evaluated by enzyme-linked immunosorbent spot and proliferation assays : there was no difference in the percentage of patients with interferon - secreting cells and a specific T-cell proliferation to HBcAg but not to HBsAg after reactivation in each group .
CONCLUSIONS	Although it is fairly well tolerated , the HBV DNA vaccine does not decrease the risk of relapse in HBV-treated patients or the rate of virological breakthrough , and does not restore the anti-HBV immune response despite effective viral suppression by analogues .
BACKGROUND	NCT00536627 .

###24986816
OBJECTIVE	At present , there is debate about the gastrointestinal effects of A1-type beta-casein protein in cows ' milk compared with the progenitor A2 type .
OBJECTIVE	In vitro and animal studies suggest that digestion of A1 but not A2 beta-casein affects gastrointestinal motility and inflammation through the release of beta-casomorphin-7 .
OBJECTIVE	We aimed to evaluate differences in gastrointestinal effects in a human adult population between milk containing A1 versus A2 beta-casein .
METHODS	Forty-one females and males were recruited into this double-blinded , randomised 8-week cross-over study .
METHODS	Participants underwent a 2-week dairy washout ( rice milk replaced dairy ) , followed by 2 weeks of milk ( 750ml/day ) that contained beta-casein of either A1 or A2 type before undergoing a second washout followed by a final 2 weeks of the alternative A1 or A2 type milk .
RESULTS	The A1 beta-casein milk led to significantly higher stool consistency values ( Bristol Stool Scale ) compared with the A2 beta-casein milk .
RESULTS	There was also a significant positive association between abdominal pain and stool consistency on the A1 diet ( r = 0.520 , P = 0.001 ) , but not the A2 diet ( r = -0.13 , P = 0.43 ) .
RESULTS	The difference between these two correlations ( 0.52 versus -0.13 ) was highly significant ( P < 0.001 ) .
RESULTS	Furthermore , some individuals may be susceptible to A1 beta-casein , as evidenced by higher faecal calprotectin values and associated intolerance measures .
CONCLUSIONS	These preliminary results suggest differences in gastrointestinal responses in some adult humans consuming milk containing beta-casein of either the A1 or the A2 beta-casein type , but require confirmation in a larger study of participants with perceived intolerance to ordinary A1 beta-casein-containing milk .

###24425854
OBJECTIVE	To determine whether daily irrigation with sterile saline solution during silicone hydrogel ( SiH ) contact lens continuous wear ( CW ) can mitigate increases in corneal epithelial permeability ( Pdc ) and reduce the risk of adverse events .
METHODS	In this study , 161 non-contact lens wearers were fit with SiH contact lenses and randomized to either a treatment ( n = 81 ) or control ( n = 80 ) group for 30-day CW .
METHODS	Subjects in the treatment group irrigated every morning and whenever dryness symptoms occurred ; subjects in the control group did not .
METHODS	Mixed effects models were employed to assess the changes in Pdc , and survival analysis methods were employed to estimate the risk for adverse events .
RESULTS	Epithelial permeability increased over 30-day CW with SiH lenses ( P = 0.001 ) .
RESULTS	Risk of inflammatory ( odds ratio [ OR ] = 1.94 ) and lens-induced ( OR = 1.90 ) adverse events increased with irrigation ; these events also occurred sooner , on average , in the irrigation group .
RESULTS	Although the overall risk for Asians was higher than for non-Asians , irrigation had no significant impact on risk among Asians , but significantly increased risk among non-Asians .
CONCLUSIONS	Thirty-day CW results in a measurable increase in epithelial permeability .
CONCLUSIONS	Risk of inflammatory and lens-induced adverse events also increase over time during CW .
CONCLUSIONS	Daily irrigation with sterile saline solution did not mitigate increases in epithelial permeability or decrease risk of adverse events .

###25524831
BACKGROUND	We aimed to detail the effects of hydroxyethyl starch ( HES ) vs. Ringer 's on kidney function including the interaction with mortality in post-hoc analyses as resuscitation with HES 130/0 .42 increased mortality in the Scandinavian Starch for Severe Sepsis/Septic Shock ( 6S ) trial .
METHODS	In all 798 randomised patients , we assessed the incidence and effect on mortality of acute kidney injury ( AKI ) in the HES vs. Ringer 's acetate groups using the Kidney Disease : Improving Global Outcome criteria .
METHODS	We also assessed the intervention effect on time to and duration of renal replacement therapy ( RRT ) .
RESULTS	At baseline , the intervention groups were similar .
RESULTS	The maximal AKI stage was higher in the HES vs. Ringer 's group within the first 5 days after randomisation ( P = 0.03 ) , the average difference being 0.2 points ( P < 0.01 ) .
RESULTS	An increase in AKI stage was associated with mortality ( hazard ratio ( HR ) 1.35 ; 95 % CI 1.22 to 1.49 ; P < 0.01 ) .
RESULTS	Significantly , more patients in the HES group received RRT within the first 5 days ( P = 0.01 ) , and the time to initiation of RRT was also shorter compared with the Ringer 's group ( HR 1.40 ; 95 % CI 1.01-1 .93 ; P = 0.04 ) .
RESULTS	The intervention effect of HES on mortality was reduced when adjusting for AKI stage as a time-dependent covariate ( P = 0.15 ) .
CONCLUSIONS	In patients with severe sepsis , HES appeared to increase the rate of severe AKI and use of RRT within the first 5 days .
CONCLUSIONS	The increased mortality observed with HES may have been partly mediated through acute kidney impairment .

###24733191
OBJECTIVE	To compare the efficacy and safety of Tripterygium wilfordii Hook F ( TwHF ) with methotrexate ( MTX ) in the treatment of active rheumatoid arthritis ( RA ) .
METHODS	Design : a multicentre , open-label , randomised controlled trial .
METHODS	All patients were assessed by trained investigators who were unaware of the therapeutic regimen .
METHODS	207 patients with active RA were randomly allocated ( 1:1:1 ) to treatment with MTX 12.5 mg once a week , or TwHF 20mg three times a day , or the two in combination .
METHODS	At week 12 , if reduction of the 28-joint count Disease Activity Score ( DAS28 ) was < 30 % in the monotherapy groups , the patient was switched to MTX+T wHF .
METHODS	The primary efficacy point was the proportion of patients achieving an American College of Rheumatology ( ACR ) 50 response at week 24 .
RESULTS	174/207 ( 84.1 % ) patients completed 24weeks of the trial .
RESULTS	In an intention-to-treat analysis , the proportion of patients reaching the ACR50 response criteria was 46.4 % ( 32/69 ) , 55.1 % ( 38/69 ) and 76.8 % ( 53/69 ) , respectively , in the MTX , TwHF and MTX+T wHF groups ( TwHF vs MTX monotherapy , p = 0.014 ; MTX+T wHF vs MTX monotherapy , p < 0.001 ) .
RESULTS	Similar statistically significant patterns at week 24 were found for ACR20 , ACR70 , clinical Disease Activity Index good responses , EULAR good response , remission rate and low disease activity rate .
RESULTS	Significant improvement in the Health Assessment Questionnaire and 36-item Short-Form Health Survey questionnaire scores from baseline to week 24 was seen in each treatment arm ( p < 0.05 ) , though no significant difference was found among the treatment arms ( p > 0.05 ) .
RESULTS	The result of per-protocol analysis agreed with that seen in the intention-to-treat analysis .
RESULTS	Seven , three and five women in the TwHF , MTX and combination groups , respectively , developed irregular menstruation ( TwHF vs MTX monotherapy , p = 0.216 ) .
CONCLUSIONS	TwHF monotherapy was not inferior to , and MTX+T wHF was better than , MTX monotherapy in controlling disease activity in patients with active RA .
BACKGROUND	NCT01613079 .

###25485857
BACKGROUND	Fibromyalgia is a chronic musculoskeletal pain syndrome characterized by a broad spectrum of manifestations .
BACKGROUND	Patients with fibromyalgia frequently suffer from manifestations similar to those experienced by patients with gluten-related disorders raising the possibility that some patients with fibromyalgia could suffer from underlying gluten sensitivity .
OBJECTIVE	This study aims to assess whether avoiding gluten among patients with fibromyalgia and gluten sensitivity is beneficial .
METHODS	Adult patients with fibromyalgia presenting gluten sensitivity symptoms are randomly allocated to receive gluten-free diet or hypocaloric diet for 24 weeks .
METHODS	The primary outcome measure is the mean change in the number of experienced gluten sensitivity symptoms .
METHODS	Secondary outcome measures include the mean changes in the body mass index , Revised Fibromyalgia Impact Questionnaire , Pittsburgh Sleep Quality Index , Brief Pain Inventory , Beck Depression Inventory-II , State-Trait Anxiety Inventory , Short-Form Health Survey and Patient Global Impression Scale of Severity .
METHODS	Other secondary outcome measures include the frequency of potential adverse events and the proportion of responders according to the Patient Global Impression Scale of Improvement .
CONCLUSIONS	Previous studies assessing dietary interventions in fibromyalgia primarily evaluated their effects on the severity and impact of fibromyalgia symptoms and pain .
CONCLUSIONS	The current study is the first to evaluate the effects of gluten-free diet on the gluten sensitivity symptoms experienced by patients with fibromyalgia .
CONCLUSIONS	The results of this study will contribute to a better understanding of the potential role of gluten sensitivity in fibromyalgia .

###25615001
BACKGROUND	Primary medication nonadherence ( PMN ) , defined as patients not picking up an initial prescription , can limit the effectiveness of therapy for chronic conditions .
BACKGROUND	Effective interventions to reduce PMN have not been widely studied or implemented .
OBJECTIVE	To evaluate the ability of an additional nurse-directed telephone intervention to reduce PMN in a cohort of patients with persistent nonadherence after repeated pharmacy-based outreach .
METHODS	Patients in the Geisinger Health System receiving new ( i.e. , initially prescribed ) prescriptions sent to CVS pharmacies for medications treating asthma , hypertension , diabetes , or hyperlipidemia were identified .
METHODS	As part of existing programs , all patients received 2 automated and 1 live call from CVS pharmacies encouraging them to pick up their prescriptions ; those who had canceled their prescriptions or had not picked them up after the 3 pharmacy interventions were eligible for this study .
METHODS	Patients were then randomized , and the intervention group received telephone outreach from a nursing call center to assess reasons for PMN and encourage pickup of prescriptions , with up to 3 attempts to reach each patient .
METHODS	Medication pickup rates were compared across the intervention and control groups .
RESULTS	Initial PMN rates in the overall population were 6 % , lower than previously observed in other studies .
RESULTS	A total of 290 patients had not picked up their prescriptions after 3 calls from the pharmacy and were enrolled in the study : 142 in the intervention group and 148 controls .
RESULTS	The intervention did not change the rate at which patients picked up their prescriptions : 25 % of intervention patients did so compared with 24 % of control patients .
RESULTS	Multivariate models adjusting for patient characteristics and medication classes did not change the results .
CONCLUSIONS	In a population of patients who had not picked up new prescriptions after 3 calls from the pharmacy , additional nurse-directed outreach did not improve primary medication adherence .
CONCLUSIONS	Re-engagement with the prescribing clinician may be needed to improve adherence in this patient population .
CONCLUSIONS	The low rate of PMN in the overall population differed from prior studies in this setting and others and should be assessed in future research .

###24934893
BACKGROUND	Small studies have yielded divergent results for administration of granulocyte colony-stimulating factor ( G-CSF ) after acute myocardial infarction .
BACKGROUND	Adequately powered studies involving patients with at least moderate left ventricular dysfunction are lacking .
METHODS	Patients with left ventricular ejection fraction less than 45 % after anterior-wall myocardial infarction were treated with G-CSF ( 10 g/kg daily for 4 days ) or placebo .
METHODS	After initial randomization of 86 patients , 41 in the placebo group and 39 in the G-CSF group completed 6-month follow-up and underwent measurement of left ventricular ejection fraction by radionuclide angiography .
RESULTS	Baseline and 6-week mean ejection fraction was similar for the G-CSF and placebo groups : 34.8 % ( 95 % confidence interval [ CI ] 32.6 % -37.0 % ) v. 36.4 % ( 95 % CI 33.5 % -39.2 % ) at baseline and 39.8 % ( 95 % CI 36.2 % -43.4 % ) v. 43.1 % ( 95 % CI 39.2 % -47.0 % ) at 6 weeks .
RESULTS	However , G-CSF therapy was associated with a lower ejection fraction at 6 months relative to placebo ( 40.8 % [ 95 % CI 37.4 % -44.2 % ] v. 46.0 % [ 95 % CI 42.7 % -44.3 % ] ) .
RESULTS	Both groups had improved left ventricular function , but change in left ventricular ejection fraction was lower in patients treated with G-CSF than in those who received placebo ( 5.7 [ 95 % CI 3.4-8 .1 ] percentage points v. 9.2 [ 95 % CI 6.3-12 .1 ] percentage points ) .
RESULTS	One or more of a composite of several major adverse cardiac events occurred in 8 patients ( 19 % ) within each group , with similar rates of target-vessel revascularization .
CONCLUSIONS	In patients with moderate left ventricular dysfunction following anterior-wall infarction , G-CSF therapy was associated with a lower 6-month left ventricular ejection fraction but no increased risk of major adverse cardiac events .
CONCLUSIONS	Future studies of G-CSF in patients with left ventricular dysfunction should be monitored closely for safety .
BACKGROUND	ClinicalTrials.gov , no .
BACKGROUND	NCT00394498 .

###25439611
OBJECTIVE	To examine the long-term effect of donor diabetes history on graft failure and endothelial cell density ( ECD ) after penetrating keratoplasty ( PK ) in the Cornea Donor Study .
METHODS	Multicenter , prospective , double-masked , controlled clinical trial .
METHODS	One thousand ninety subjects undergoing PK for a moderate risk condition , principally Fuchs ' dystrophy or pseudophakic or aphakic corneal edema , were enrolled by 105 surgeons from 80 clinical sites in the United States .
METHODS	Corneas from donors 12 to 75 years of age were assigned by 43 eye banks to participants without respect to recipient factors .
METHODS	Donor and recipient diabetes status was determined from existing medical records .
METHODS	Images of the central endothelium were obtained before surgery ( baseline ) and at intervals for 10 years after surgery and were analyzed by a central image analysis reading center to determine ECD .
METHODS	Time to graft failure ( regraft or cloudy cornea for 3 consecutive months ) and ECD .
RESULTS	There was no statistically significant association of donor diabetes history with 10-year graft failure , baseline ECD , 10-year ECD , or ECD values longitudinally over time in unadjusted analyses , nor after adjusting for donor age and other significant covariates .
RESULTS	The 10-year graft failure rate was 23 % in the 199 patients receiving a cornea from a donor with diabetes versus 26 % in the 891 patients receiving a cornea from a donor without diabetes ( 95 % confidence interval for the difference , -10 % to 6 % ; unadjusted P = 0.60 ) .
RESULTS	Baseline ECD ( P = 0.71 ) , 10-year ECD ( P > 0.99 ) , and changes in ECD over 10 years ( P = 0.86 ) were similar comparing donor groups with and without diabetes .
CONCLUSIONS	The study results do not suggest an association between donor diabetes and PK outcome .
CONCLUSIONS	However , the assessment of donor diabetes was imprecise and based on historical data only .
CONCLUSIONS	The increasing frequency of diabetes in the aging population in the United States affects the donor pool .
CONCLUSIONS	Thus , the impact of donor diabetes on long-term endothelial health after PK or endothelial keratoplasty , or both , warrants further study with more precise measures of diabetes and its complications .

###24268210
BACKGROUND	Although high-sensitivity cardiac troponin ( hs-cTn ) substantially improves the early detection of myocardial injury , it lacks specificity for acute myocardial infarction ( MI ) .
BACKGROUND	In suspected non-ST-elevation MI , invasive coronary angiography ( ICA ) remains necessary to distinguish between acute MI and noncoronary myocardial disease ( eg , myocarditis ) , unnecessarily subjecting the latter to ICA and associated complications .
BACKGROUND	This trial investigates whether implementing cardiovascular magnetic resonance ( CMR ) or computed tomography angiography ( CTA ) early in the diagnostic process may help to differentiate between coronary and noncoronary myocardial disease , thereby preventing unnecessary ICA .
METHODS	In this prospective , single-center , randomized controlled clinical trial , 321 consecutive patients with acute chest pain , elevated hs-cTnT , and nondiagnostic electrocardiogram are randomized to 1 of 3 strategies : ( 1 ) CMR , or ( 2 ) CTA early in the diagnostic process , or ( 3 ) routine clinical management .
METHODS	In the 2 investigational arms of the study , results of CMR or CTA will guide further clinical management .
METHODS	It is expected that noncoronary myocardial disease is detected more frequently after early noninvasive imaging as compared with routine clinical management , and unnecessary ICA will be prevented .
METHODS	The primary end point is the total number of patients undergoing ICA during initial admission .
METHODS	Secondary end points are 30-day and 1-year clinical outcome ( major adverse cardiac events and major procedure-related complications ) , time to final diagnosis , quality of life , and cost-effectiveness .
CONCLUSIONS	The CARMENTA trial investigates whether implementing CTA or CMR early in the diagnostic process in suspected non-ST-elevation MI based on elevated hs-cTnT can prevent unnecessary ICA as compared with routine clinical management , with no detrimental effect on clinical outcome .

###25402168
OBJECTIVE	Biomarkers can provide objective measures of dietary exposure , but their relationship with dietary intake in different populations needs to be characterized .
OBJECTIVE	This study aimed to determine the association between C14 :0 , C15 :0 and C17 :0 and children 's dairy fat intake , and to ascertain whether these fatty acids can be used as biomarkers for detecting change in dairy fat intake .
METHODS	Data from a randomized controlled trial ( 114 healthy children of 4-13 years of age ) was used .
METHODS	The intervention was a replacement of regular-fat dairy foods with reduced-fat or low-fat items .
METHODS	Serum fatty acid composition was measured and dairy intake was assessed via 3 24-hour diet recalls at baseline and at 12 weeks ( the end of the intervention ) .
METHODS	Correlation analysis was used to evaluate the relationship between dietary intake and fatty acids at baseline and at week 12 , and for the change in biomarkers and diet between these time points .
RESULTS	Total dairy fat intake correlated with C14 :0 , C15 :0 and C17 :0 at baseline ( n = 114 ; r = 0.24 ; r = 0.42 ; r = 0.25 respectively , all p < 0.05 ) , but not at week 12 .
RESULTS	The change in the total amount of dairy fat ( g/day ) after 12 weeks was associated with a change in serum C15 :0 ( n = 59 ; r = 0.27 ; p = 0.04 ) .
CONCLUSIONS	C15 :0 is a useful biomarker of dairy fat intake in children and can detect short-term changes in the absolute intake of dairy fat .

###24767003
BACKGROUND	The intravenous administration of scopolamine produces rapid antidepressant effects .
BACKGROUND	Generally , failing multiple previous antidepressant trials is associated with a poor prognosis for response to future medications .
BACKGROUND	This study evaluated whether treatment history predicts antidepressant response to scopolamine .
METHODS	Treatment resistant patients ( 2 failed medication trials ) ( n = 31 ) and treatment nave patients ( no exposure to psychotropic medication ) ( n = 31 ) with recurrent major depressive or bipolar disorder participated in a double-blind , placebo-controlled , crossover clinical trial .
METHODS	Following a placebo lead-in , participants randomly received P/S or S/P ( P = 3 placebo ; S = 3 scopolamine ( 4ug/kg ) sessions 3 to 5 days apart ) .
METHODS	The Montgomery-Asberg Depression Rating Scale ( MADRS ) was the primary outcome measure .
METHODS	A linear mixed model was used to examine the interaction between clinical response and treatment history , adjusting for baseline MADRS .
RESULTS	Treatment resistant and treatment nave subjects combined responded significantly to scopolamine compared to placebo ( F = 15.06 , p < 0.001 ) .
RESULTS	Reduction in depressive symptoms was significant by the first post-scopolamine session ( F = 42.75 , p < 0.001 ) .
RESULTS	A treatment history by scopolamine session interaction ( F = 3.37 , p = 0.04 ) indicated treatment nave subjects had lower MADRS scores than treatment resistant patients ; this was significant after the second scopolamine infusion ( t = 2.15 , p = 0.03 ) .
CONCLUSIONS	Post-hoc analysis : Also , we used a single regimen to administer scopolamine , and smokers were excluded from the sample , limiting generalizability .
CONCLUSIONS	Treatment nave and treatment resistant patients showed improved clinical symptoms following scopolamine , while those who were treatment nave showed greater improvement .
CONCLUSIONS	Scopolamine rapidly reduces symptoms in both treatment history groups , and demonstrates sustained improvement even in treatment resistant patients .

###24949564
BACKGROUND	Heavy drinking smokers constitute a sizeable and hard-to-treat subgroup of smokers , for whom tailored smoking cessation therapies are not yet available .
OBJECTIVE	The present study used a double-blind , randomized , 22 medication design , testing varenicline alone ( VAR ; 1mg twice daily ) , naltrexone alone ( NTX ; 25mg once daily ) , varenicline plus naltrexone , and placebo for effects on neural activation to cigarette cues in a sample ( n = 40 ) of heavy drinking daily smokers ( 10 cigarettes/day ) .
METHODS	All participants were tested after a 10-12-day titration period designed to reach steady state on the target medication .
METHODS	Participants underwent functional neuroimaging ( fMRI ) for examination of brain responses to visual smoking-related ( vs. neutral ) cues .
RESULTS	Region of interest ( ROI ) analyses of brain responses to Cigarette vs. Neutral Cues indicated that the combination of VAR+NTX was associated with reduced activation of the bilateral anterior cingulate cortex as compared to placebo and to NTX alone .
RESULTS	Exploratory whole-brain analyses also indicated significant differences in brain activation during cigarette cues in the active medications versus placebo condition .
RESULTS	All medications suppressed left nucleus accumbens activation relative to placebo , suggesting the possibility that both medications , either alone or in combination , reduce neural signals associated with appetitive behavior .
CONCLUSIONS	Although preliminary , these neuroimaging findings indicate that clinical studies of the combination of VAR+NTX for heavy drinkers trying to quit smoking may be warranted .

###25456363
BACKGROUND	Poor prognosis germ-cell tumours are only cured in about half of patients .
BACKGROUND	We aimed to assess whether treatment intensification based on an early tumour marker decline will improve progression-free survival for patients with germ-cell tumours .
METHODS	In this phase 3 , multicentre , randomised trial , patients were enrolled from France ( 20 centres ) , USA ( one centre ) , and Slovakia ( one centre ) .
METHODS	Patients were eligible if they were older than 16 years , had evidence of testicular , retroperitoneal , or mediastinal non-seminomatous germ cell tumours based on histological findings or clinical evidence and highly elevated serum human chorionic gonadotropin or alfa-fetoprotein concentrations that matched International Germ Cell Cancer Consensus Group poor prognosis criteria .
METHODS	After one cycle of BEP ( intravenous cisplatin [ 20 mg/m ( 2 ) per day for 5 days ] , etoposide [ 100 mg/m ( 2 ) per day for 5 days ] , and intramuscular or intravenous bleomycin [ 30 mg per day on days 1 , 8 , and 15 ] ) , patients ' human chorionic gonadotropin and alfa-fetoprotein concentrations were measured at day 18-21 .
METHODS	Patients with a favourable decline in human chorionic gonadotropin and alfa-fetoprotein continued BEP ( Fav-BEP group ) for 3 additonal cycles , whereas patients with an unfavourable decline were randomly assigned ( 1:1 ) to receive either BEP ( Unfav-BEP group ) or a dose-dense regimen ( Unfav-dose-dense group ) , consisting of intravenous paclitaxel ( 175 mg/m ( 2 ) over 3 h on day 1 ) before BEP plus intravenous oxaliplatin ( 130 mg/m ( 2 ) over 3 h on day 10 ; two cycles ) , followed by intravenous cisplatin ( 100 mg/m ( 2 ) over 2 h on day 1 ) , intravenous ifosfamide ( 2 g/m ( 2 ) over 3 h on days 10 , 12 , and 14 ) , plus mesna ( 500 mg/m ( 2 ) at 0 , 3 , 7 and 11 h ) , and bleomycin ( 25 units per day , by continuous infusion for 5 days on days 10-14 ; two cycles ) , with granulocyte-colony stimulating factor ( lenograstim ) support .
METHODS	Centrally blocked computer-generated randomisation stratified by centre was used .
METHODS	The primary endpoint was progression-free survival and the efficacy analysis was done in the intention-to-treat population .
METHODS	The planned trial accrual was completed in May , 2012 , and follow-up is ongoing .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00104676 .
RESULTS	Between Nov 28 , 2003 , and May 16 , 2012 , 263 patients were enrolled and 254 were available for tumour marker assessment .
RESULTS	Of these 51 ( 20 % ) had a favourable marker assessment , and 203 ( 80 % ) had an unfavourable tumour marker decline ; 105 were randomly assigned to the Unfav-dose-dense group and 98 to the Unfav-BEP group .
RESULTS	3-year progression-free survival was 59 % ( 95 % CI 49-68 ) in the Unfav-dose-dense group versus 48 % ( 38-59 ) in the Unfav-BEP group ( HR 066 , 95 % CI 044-100 , p = 005 ) .
RESULTS	3-year progression-free survival was 70 % ( 95 % CI 57-81 ) in the Fav-BEP group ( HR 066 , 95 % CI 049-088 , p = 001 for progression-free survival compared with the Unfav-BEP group ) .
RESULTS	More grade 3-4 neurotoxic events ( seven [ 7 % ] vs one [ 1 % ] ) and haematotoxic events occurred in the Unfav-dose-dense group compared with in the Unfav-BEP group ; there was no difference in grade 1-2 febrile neutropenia ( 18 [ 17 % ] vs 18 [ 18 % ] ) or toxic deaths ( one [ 1 % ] in both groups ) .
RESULTS	Salvage high-dose chemotherapy plus a stem-cell transplant was required in six ( 6 % ) patients in the Unfav-dose-dense group and 16 ( 16 % ) in the Unfav-BEP group .
CONCLUSIONS	Personalised treatment with chemotherapy intensification reduces the risk of progression or death in patients with poor prognosis germ-cell tumours and an unfavourable tumour marker decline .
BACKGROUND	Institut National du Cancer ( Programme Hospitalier de Recherche Clinique ) .

###24585267
OBJECTIVE	Diminished diuretic response is common in patients with acute heart failure , although a clinically useful definition is lacking .
OBJECTIVE	Our aim was to investigate a practical , workable metric for diuretic response , examine associated patient characteristics and relationships with outcome .
RESULTS	We examined diuretic response ( defined as weight kg/40 mg furosemide ) in 1745 hospitalized acute heart failure patients from the PROTECT trial .
RESULTS	Day 4 response was used to allow maximum differentiation in responsiveness and tailoring of diuretic doses to clinical response , following sensitivity analyses .
RESULTS	We investigated predictors of diuretic response and relationships with outcome .
RESULTS	The median diuretic response was -0.38 ( -0.80 to -0.13 ) kg/40 mg furosemide .
RESULTS	Poor diuretic response was independently associated with low systolic blood pressure , high blood urea nitrogen , diabetes , and atherosclerotic disease ( all P < 0.05 ) .
RESULTS	Worse diuretic response independently predicted 180-day mortality ( HR : 1.42 ; 95 % CI : 1.11-1 .81 , P = 0.005 ) , 60-day death or renal or cardiovascular rehospitalization ( HR : 1.34 ; 95 % CI : 1.14-1 .59 , P < 0.001 ) and 60-day HF rehospitalization ( HR : 1.57 ; 95 % CI : 1.24-2 .01 , P < 0.001 ) in multivariable models .
RESULTS	The proposed metric-weight loss indexed to diuretic dose-better captures a dose-response relationship .
RESULTS	Model diagnostics showed diuretic response provided essentially the same or slightly better prognostic information compared with its individual components ( weight loss and diuretic dose ) in this population , while providing a less biased , more easily interpreted signal .
CONCLUSIONS	Worse diuretic response was associated with more advanced heart failure , renal impairment , diabetes , atherosclerotic disease and in-hospital worsening heart failure , and predicts mortality and heart failure rehospitalization in this post hoc , hypothesis-generating study .

###25315665
BACKGROUND	Calcium pyrophosphate deposition ( CPPD ) may cause severe arthropathy , major joint destruction and treatment options are limited .
BACKGROUND	The aim of this study was to test the therapeutic efficacy of methotrexate ( MTX ) in chronic or recurrent CPPD arthropathy .
METHODS	Patients with CPPD arthropathy were randomized to receive either weekly subcutaneous injections of 15 mg/week of MTX or placebo ( PBO ) for three months , in a double-blind , crossover randomized controlled trial .
METHODS	Inclusion criteria comprised definite CPPD disease , recurrent arthritis or persistent polyarthritis , and an insufficient response to NSAIDs , glucocorticoids or colchicine .
METHODS	The primary outcome was an improvement in the disease activity scores based on 44 joints ( DAS44 ) .
METHODS	The analysis was performed on an intent-to-treat basis .
RESULTS	We randomized 26 patients , and compared 25 treatment periods on MTX with 21 treatment periods on PBO .
RESULTS	Baseline characteristics were balanced between the groups .
RESULTS	The evolution of the DAS44 was not statistically significantly different between groups ( median DAS44 decreased by -0.08 on MTX versus -0.13 on PBO , after three months , P = 0.44 ) .
RESULTS	Furthermore , pain levels remained stable in both groups ( median change in VAS Pain -1 unit on MTX and 0 on PBO , P = 0.43 ) , and none of the secondary outcomes was significantly different between the two groups .
RESULTS	Minor adverse events ( AE ) did not differ in frequency between the groups , but the only serious AE occurred on MTX ( bicytopenia ) .
CONCLUSIONS	The results of this trial with MTX in this older population with chronic or recurrent CPPD arthropathy suggest no strong effect of MTX on disease activity .
BACKGROUND	EudraCT No : 2007-003479-37 .
BACKGROUND	Registered 26 April 2008 .

###25061313
BACKGROUND	Systolic hypertension is the most common form of hypertension in elderly patients .
BACKGROUND	There is increasing evidence that measurement of central aortic pressure ( CAP ) better accounts for cardiovascular risk than brachial blood pressure ( BP ) .
BACKGROUND	The Aliskiren for GEriatric LowEring of SyStolic hypertension ( AGELESS ) study in elderly patients with systolic hypertension showed that aliskiren-based therapy provided greater reductions in peripheral BP than ramipril-based therapy over 12 and 36 weeks of treatment .
BACKGROUND	Here , we present CAP results in a substudy of elderly patients from the AGELESS study .
METHODS	This was a post hoc analysis of a 36-week , randomized , double-blind , parallel-group , active-controlled , optional-titration study in patients 65 years of age with systolic BP 140 mmHg .
METHODS	Changes in both central and peripheral BP and pulse pressure ( PP ) and changes in systolic and PP amplification ratios from baseline to the week 36 end point with aliskiren-based versus ramipril-based therapy were analyzed .
RESULTS	Of the 901 patients randomized in the overall study , 154 patients ( aliskiren , n = 78 ; ramipril , n = 76 ) had CAP data .
RESULTS	Numerically comparable reductions were seen for central aortic systolic pressure ( CASP ) in aliskiren-based therapy ( baseline : 143.715.0 ; week 36 : -20.316.2 ) compared with ramipril-based therapy ( baseline : 147.911.9 ; week 36 : -20.714.6 ) .
RESULTS	However , for the change in central aortic diastolic pressure , the least squares mean between-treatment difference ( -3.6 mmHg [ 95 % confidence interval , -6.76 , -0.43 ; P = 0.0263 ] ) was in favor of aliskiren , while the other changes were comparable between the two groups with a trend in favor of aliskiren for CASP as well ( -2.6 mmHg [ 95 % confidence interval , -7.38 , 2.19 ; P = 0.2855 ) ] .
RESULTS	Correlation coefficients for change from baseline between CASP and systolic BP and between central aortic pulse pressure and PP ( r = 0.8 , P < 0.0001 ) were highly significant .
CONCLUSIONS	Aliskiren-based therapy provides comparable reductions in CASP to ramipril-based therapy .
CONCLUSIONS	Although the results did not reach statistical significance , these findings , when coupled with those of the main study , suggest that aliskiren may offer effective control of central BP in elderly patients with systolic hypertension and may be a good alternative to ramipril .

###24655464
OBJECTIVE	Conduct a pilot trial testing whether a brief cognitive-behavioral ( CB ) group reduced depressive symptoms and secondary outcomes relative to bibliotherapy and brochure controls in college students with elevated depressive symptoms .
METHODS	82 college students ( M age = 19.0 , SD = 0.9 ; 70 % female , 80 % White ) with elevated self-assessed depressive symptoms were randomized to a 6-session CB group , bibliotherapy , or educational brochure control condition , completing assessments at pretest , posttest , and at 6 - and 12-month follow-up .
RESULTS	Planned contrasts found no significant effects for CB group on depressive symptoms compared to either bibliotherapy or brochure controls at posttest ( d = -.08 and .06 , respectively ) or over follow-up ( d = -.04 and -.10 , respectively ) .
RESULTS	There were no intervention effects for social adjustment and substance use , though CB group participants had improved knowledge of CB concepts at posttest , versus brochure controls .
RESULTS	Condition differences in major depression onset were nonsignificant but suggested support for CB interventions ( CB group = 7.4 % , bibliotherapy = 4.5 % , brochure control = 15.2 % ) .
CONCLUSIONS	Unexpectedly modest support was found for a brief CB group depression prevention intervention , compared to bibliotherapy or brochure control , when provided to self-selected college students , suggesting that alternative screening or interventions approaches are needed for this population .

###24876156
BACKGROUND	Sexual dysfunction ( SD ) affects up to 80 % of multiple sclerosis ( MS ) patients and pelvic floor muscles ( PFMs ) play an important role in the sexual function of these patients .
OBJECTIVE	The objective of this paper is to evaluate the impact of a rehabilitation program to treat lower urinary tract symptoms on SD of women with MS.
METHODS	Thirty MS women were randomly allocated to one of three groups : pelvic floor muscle training ( PFMT ) with electromyographic ( EMG ) biofeedback and sham neuromuscular electrostimulation ( NMES ) ( Group I ) , PFMT with EMG biofeedback and intravaginal NMES ( Group II ) , and PFMT with EMG biofeedback and transcutaneous tibial nerve stimulation ( TTNS ) ( Group III ) .
METHODS	Assessments , before and after the treatment , included : PFM function , PFM tone , flexibility of the vaginal opening and ability to relax the PFMs , and the Female Sexual Function Index ( FSFI ) questionnaire .
RESULTS	After treatment , all groups showed improvements in all domains of the PERFECT scheme .
RESULTS	PFM tone and flexibility of the vaginal opening was lower after the intervention only for Group II .
RESULTS	All groups improved in arousal , lubrication , satisfaction and total score domains of the FSFI questionnaire .
CONCLUSIONS	This study indicates that PFMT alone or in combination with intravaginal NMES or TTNS contributes to the improvement of SD .

###25560809
OBJECTIVE	To report pre-specified and exploratory results on the effect of different surgical approaches on erectile function ( EF ) after nerve-sparing radical prostatectomy ( nsRP ) obtained from the multicentre , randomised , double-blind , double-dummy REACTT trial of tadalafil ( once a day [ OaD ] or on-demand [ pro-re-nata , PRN ] ) vs placebo .
METHODS	Patients aged < 68years with normal preoperative EF who underwent nsRP for localised prostate cancer ( Gleason 7 , prostate-specific antigen [ PSA ] < 10ng/mL ) were randomised after nsRP 1:1:1 to 9-month double-blind treatment with tadalafil 5mg OaD , tadalafil 20mg PRN , or placebo , followed by 6-week drug-free washout , and 3-month open-label OaD treatment ( all patients ) .
METHODS	Recovery of EF was defined as an International Index of Erectile Function ( IIEF ) - EF domain score of 22 and normal orgasmic function was defined based on IIEF Question 10 .
METHODS	Both parameters were analysed at the end of washout using logistic regression including terms for treatment , country , visit , visit-by-treatment interaction , age group , nerve-sparing score ( perfect = 2 , non-perfect > 2 ) , and surgical approach ( open surgery , robot-assisted laparoscopy , conventional laparoscopy , other ) .
METHODS	Time to EF recovery was analysed post hoc with a Cox proportional-hazards model including terms for treatment , age-group , country , surgical approach and surgery-by-treatment interaction .
RESULTS	Of 422 patients treated , 189 underwent open surgery , 115 robot-assisted laparoscopy , 88 conventional laparoscopy and 30 surgery classified as ` other ' .
RESULTS	The odds of achieving EF recovery at the end of drug-free washout were about twice as high for the robot-assisted laparoscopy group compared with the open surgery group ( odds ratio 2.42 ; 95 % confidence interval [ CI ] 1.24 , 4.72 ; P = 0.029 ) .
RESULTS	Patients who underwent robot-assisted laparoscopy were significantly more likely to recover during double-blind treatment compared with patients who underwent open surgery ( hazard ratio 1.92 ; 95 % CI 1.17 , 3.15 ; P = 0.010 ) .
RESULTS	No favourable effect of conventional laparoscopy compared with open surgery could be seen .
CONCLUSIONS	These results may provide further insights into the role of surgery on EF recovery after nsRP .
CONCLUSIONS	However , the trial was not designed for these analyses and further prospective studies are needed .

###24834887
OBJECTIVE	To prospectively assess the contrast enhancement , image quality , radiation dose , and detectability of malignant pancreatic tumors with pancreatic computed tomography ( CT ) obtained at an 80-kilovolt ( peak ) ( kV [ p ] ) tube voltage setting and reduced iodine dose .
METHODS	Institutional review board approval and written informed consent were obtained .
METHODS	During a recent 10-month period , 136 patients ( 66 men and 70 women ; age range , 21-86 years ; mean SD age , 65.9 11.0 years ) with suspected pancreatic disease were randomized into 3 groups according to the following iodine-load and tube-voltage protocols : 600 mg of iodine per kilogram body weight ( mg/kg ) and 120 kV ( p ) ( 600-120 group ) , 500 mg/kg and 80 kV ( p ) ( 500-80 group ) , and 400 mg/kg and 80 kV ( p ) ( 400-80 group ) .
METHODS	Analysis of variance was conducted to evaluate differences in CT number , background noise , signal-to-noise ratio , effective dose , lesion-to-pancreas contrast-to-noise ratio , and figure of merit .
METHODS	Sensitivity , specificity , and area under the receiver-operating-characteristic curve were compared to assess the detectability of malignant pancreatic tumors .
RESULTS	The signal-to-noise ratios in vessels were greater ( P < 0.05 ) in the 400-80 and 500-80 groups than in the 600-120 group , and those in pancreas were comparable between the 400-80 and 600-120 groups .
RESULTS	No significant difference was found in effective dose , image quality , lesion-to-pancreas contrast-to-noise ratio , or figure of merit between the groups .
RESULTS	Sensitivity , specificity , and area under the receiver-operating-characteristic curve for detecting malignant pancreatic tumors were comparable between the groups .
CONCLUSIONS	Pancreatic CT with an 80-kV ( p ) setting and 400-mg iodine per kilogram contrast material load facilitates the reduction of iodine dose while maintaining image quality and the detectability of malignant pancreatic tumors .

###24500582
BACKGROUND	Proponents of minimally invasive total knee arthroplasty argue that retracting rather than everting the patella results in quicker postoperative recovery and improved function .
BACKGROUND	We aimed to investigate this in patients undergoing knee arthroplasty through a standard medial parapatellar approach .
METHODS	In a prospective randomized double-blinded study , sixty-eight patients undergoing total knee arthroplasty through a standard medial parapatellar approach were assigned to either retraction or eversion of the patella .
METHODS	Postoperatively , at three months , and at one year after surgery , an independent observer assessed the primary outcome measure ( i.e. , knee flexion ) and secondary outcome measures ( i.e. , Oxford knee score , Short Form-12 [ SF-12 ] score , visual analog scale pain score , knee motion , and alignment and patellar height as measured on radiographs with use of the Insall-Salvati ratio ) .
RESULTS	Early ( three-month ) follow-up showed no significant difference between patellar eversion and subluxation in flexion ( mean and 95 % confidence interval [ CI ] , 101 5.37 versus 102 4.14 , respectively ) , Oxford knee scores ( 25 3 versus 27 2.69 , respectively ) , SF-12 , or visual analog scale pain scores ( 1.9 0.54 versus 1.1 0.44 , respectively ) .
RESULTS	A significant improvement in extension was found ( -3.9 1.12 versus -2.0 0.91 , respectively [ p = 0.034 ] ) , but this was not clinically significant .
RESULTS	There was no significant difference in any of the outcomes at one year .
RESULTS	There was a significant difference in implant malpositioning between the eversion group and the subluxation group , with an increased percentage of lateral tibial overhang in the subluxation group ( 0.45 0.39 versus 1.84 0.82 , respectively [ p = 0.005 ] ) , but this did not correlate with functional outcome .
RESULTS	There was no significant difference in alignment between the two groups ( 178.29 0.84 versus 178.18 0.78 ) .
RESULTS	At one year after surgery , there was no difference between the two groups in Insall-Salvati ratio ( 1.15 0.06 versus 1.12 0.06 ) although there was a correlation between the percentage reduction in the ratio and functional outcome .
RESULTS	There were two partial divisions of the patella tendon in the subluxation group , but no patella-related complications in the eversion group .
CONCLUSIONS	The results of this trial showed that retracting rather than everting the patella during total knee arthroplasty resulted in no significant clinical benefit in the early to medium term .
CONCLUSIONS	We observed no increase in patellar tendon shortening as a result of eversion rather than subluxation .
CONCLUSIONS	Our findings did suggest that , with subluxation , there may be an increased risk of damage to the patellar tendon and reduced visualization of the lateral compartment , leading to an increase in implant malpositioning with lateral tibial overhang .

###24816958
BACKGROUND	Chronic anal fissure ( CAF ) is perpetuated by high sphincter pressures and secondary local ischemia .
BACKGROUND	Pharmacological approaches include topical nitrates and botulinum toxin ( BT ) , which both help to decrease the sphincter pressure .
OBJECTIVE	The aims of the present study were to assess the efficacy and safety of BT injection and combined treatment with BT injection and lowered dose glyceryltrinitrate ( GTN ) cream for the treatment of CAF .
OBJECTIVE	We hypothesised that combined treatment would have a synergistic effect on healing .
METHODS	Forty-one consecutive patients with CAF were randomly assigned to receive one of the following treatments : Group A , injection of BT ( 20 U into internal anal sphincter ) and Group B , BT injection ( 20 units ) and subsequent thrice daily topical applications of half-dose 0.2 % GTN cream for 6 weeks .
METHODS	Patients were followed up at 6 and 12 weeks and were assessed for healing of anal fissure , by means of visual inspection using fissure grades ; for faecal incontinence , using Cleveland Clinic incontinence scores ; and for fissure pain and headache using a numeric pain rating scale .
RESULTS	Fissure healing was similar in the two groups at both 6 ( 30 % in BT and GTN and 33 % in BT only ) and 12 weeks ( 50 % in BT and GTN vs 57 % in BT-only group ) .
RESULTS	Neither the change in pain score from 6 to 12 weeks , nor the overall level of pain was significantly different in the 2 groups .
RESULTS	Moderate or severe headaches were suffered by 58 % of patients using GTN .
CONCLUSIONS	Single-agent treatment by means of BT injection alone was well tolerated compared with combination treatment with BT injection and GTN cream , with no significant differences in healing of CAF observed in this small study .

###25376714
BACKGROUND	The `` original '' traction-free Kocher 's method to perform the reduction of shoulder dislocation has been recently reviewed and some authors speculated that it can be self performed by patients under the guide of the physician .
BACKGROUND	In this way , as an `` assisted self-reduction '' technique , it is also effective and simple to perform .
BACKGROUND	The aim is to study the effectiveness of the assisted self-reduction technique , in comparison to the well known and largely used traction-countertraction method .
METHODS	From a consecutive series of 237 uncomplicated anterior shoulder dislocations , a total of 61 were managed by the residents of our institution under the supervision of the senior authors using the assisted self-reduction method and 176 were managed by other orthopaedic consultants on duty in the Emergency Department using the traction-countertraction technique .
METHODS	Only the senior authors used the assisted self-reduction technique , whereas the other orthopaedic consultants used the traction-countertraction method .
METHODS	The need for intravenous sedation or general anaesthesia to perform the assisted self-reduction was considered a failure .
METHODS	Recorded variables were demographic data , previous dislocation , traumatic mechanism and medication use during shoulder reduction , time to perform the reduction .
RESULTS	Ninety-eight percent of the acute dislocation treated with the assisted self-reduction technique and 81 % treated with the traction-countertraction method were reducible without recourse to intravenous sedation .
CONCLUSIONS	The assisted self-reduction technique is simple , effective and gentle .
CONCLUSIONS	Physicians on duty in the Emergency Departments should therefore be encouraged to use it .

###25700289
OBJECTIVE	Many ischemic strokes or transient ischemic attacks are labeled cryptogenic but may have undetected atrial fibrillation ( AF ) .
OBJECTIVE	We sought to identify those most likely to have subclinical AF .
METHODS	We prospectively studied patients with cryptogenic stroke or transient ischemic attack aged 55 years in sinus rhythm , without known AF , enrolled in the intervention arm of the 30 Day Event Monitoring Belt for Recording Atrial Fibrillation After a Cerebral Ischemic Event ( EMBRACE ) trial .
METHODS	Participants underwent baseline 24-hour Holter ECG poststroke ; if AF was not detected , they were randomly assigned to 30-day ECG monitoring with an AF auto-detect external loop recorder .
METHODS	Multivariable logistic regression assessed the association between baseline variables ( Holter-detected atrial premature beats [ APBs ] , runs of atrial tachycardia , age , and left atrial enlargement ) and subsequent AF detection .
RESULTS	Among 237 participants , the median baseline Holter APB count/24 h was 629 ( interquartile range , 142-1973 ) among those who subsequently had AF detected versus 45 ( interquartile range , 14-250 ) in those without AF ( P < 0.001 ) .
RESULTS	APB count was the only significant predictor of AF detection by 30-day ECG ( P < 0.0001 ) , and at 90 days ( P = 0.0017 ) and 2 years ( P = 0.0027 ) .
RESULTS	Compared with the 16 % overall 90-day AF detection rate , the probability of AF increased from < 9 % among patients with < 100 APBs/24 h to 9 % to 24 % in those with 100 to 499 APBs/24 h , 25 % to 37 % with 500 to 999 APBs/24 h , 37 % to 40 % with 1000 to 1499 APBs/24 h , and 40 % beyond 1500 APBs/24 h.
CONCLUSIONS	Among older cryptogenic stroke or transient ischemic attack patients , the number of APBs on a routine 24-hour Holter ECG was a strong dose-dependent independent predictor of prevalent subclinical AF .
CONCLUSIONS	Those with frequent APBs have a high probability of AF and represent ideal candidates for prolonged ECG monitoring for AF detection .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00846924 .

###25519790
METHODS	Port-au-Prince , Haiti .
OBJECTIVE	To determine long-term effects of early vs. delayed initiation of antiretroviral therapy ( ART ) on immune recovery and tuberculosis ( TB ) risk in human immunodeficiency virus ( HIV ) infected individuals .
METHODS	Open-label randomized controlled trial of immediate ART in HIV-infected adults with CD4 counts between 200 and 350 cells/mm ( 3 ) vs. deferring ART until the CD4 count was < 200 cells/mm ( 3 ) .
METHODS	The primary comparisons were CD4 counts over time and risk for incident TB , with 5 years of follow-up .
RESULTS	A total of 816 participants were enrolled , with 408 in each treatment arm .
RESULTS	The early treatment group started ART within 2 weeks , while the deferred treatment group started ART a median of 1.3 years after enrollment .
RESULTS	After 5 years , the mean CD4 count in the early treatment group was significantly higher than in the deferred treatment group ( 496 cells/mm ( 3 ) , 95 % confidence interval [ CI ] 477-515 vs. 373 cells/mm ( 3 ) , 95 % CI 357-389 ; P < 0.0001 ) .
RESULTS	TB risk was higher in the deferred treatment group ( unadjusted HR 2.41 , 95 % CI 1.56-3 .74 ; P < 0.0001 ) and strongly correlated with lower CD4 counts in time-dependent multivariate analysis .
CONCLUSIONS	Delays in ART initiation for HIV-infected adults with CD4 counts of 200-350 cells/mm ( 3 ) can result in long-term immune dysfunction and persistent increased risk for TB .

###24645907
BACKGROUND	Elderly individuals with coronary heart disease are a population particularly burdened by disability .
BACKGROUND	However , to date many predictors of disability established in general populations have not been considered in studies examining disability in elderly acute myocardial infarction ( AMI ) survivors .
BACKGROUND	Our study explores factors associated with the ability to perform basic activities of daily living in elderly patients with AMI .
METHODS	Baseline data from 333 AMI-survivors older than 64 years included within the randomized controlled KORINNA-study were utilized to examine disability assessed by the Stanford Health Assessment Questionare Disability Index ( HAQ-DI ) .
METHODS	Numerous potential determinants including demographic characteristics , clinical parameters , co-morbidities , interventions , lifestyle , behavioral and personal factors were measured.Disability was defined as a HAQ-DI 0.5 .
METHODS	After bi-variate testing the probability of disability was modeled with logistic regression .
METHODS	Missing covariate values were imputed using a Markov Chain Monte Carlo method .
RESULTS	Disability was significantly more frequent in older individuals ( Odds Ratio ( OR ) : 1.10 , 95 % Confidence Interval ( CI ) : 1.05-1 .16 ) , patients with deficient nutrition ( OR : 3.38 , 95 % CI : 1.60-7 .15 ) , coronary artery bypass graft ( CABG ) ( OR : 3.26 , 95 % CI : 1.29-8 .25 ) , hearing loss in both ears ( OR : 2.85 , 95 % CI : 1.41-5 .74 ) , diabetes mellitus ( OR : 2.56 , 95 % CI : 1.39-4 .72 ) , and heart failure ( OR : 3.32 , 95 % CI : 1.79-6 .16 ) .
RESULTS	It was reduced in patients with percutaneous transluminal coronary angioplasty ( PTCA ) ( OR : 0.41 , 95 % CI : 0.21-0 .80 ) and male sex ( OR : 0.48 , 95 % CI : 0.27-0 .85 ) .
CONCLUSIONS	Effects of nutrition , hearing loss , and diametrical effects of PTCA and CABG on disability were identified as relevant for examination of causality in longitudinal trials .
BACKGROUND	ISRCTN02893746 .

###24286591
BACKGROUND	Circulating progenitor cells ( CPCs ) improve cardiovascular function and organ perfusion by enhancing the capacities of endothelial repair and neovasculogenesis .
BACKGROUND	This study investigates whether exercise regimens with/without hypoxia affect cardiac and muscular hemodynamics by modulating CPCs and angiogenic factors .
METHODS	Forty sedentary males were randomly divided into hypoxic ( HT , n = 20 ) and normoxic ( NT , n = 20 ) training groups .
METHODS	The subjects were trained on a bicycle ergometer at 60 % VO ( 2max ) under 15 % ( HT ) or 21 % ( NT ) O2 conditions for 30 min daily , five days weekly for five weeks .
RESULTS	After the five-week interventions , the HT group exhibited a larger improvement in aerobic capacity than the NT group .
RESULTS	Furthermore , the HT regimen ( i ) enhanced cardiac output ( Q ( H ) ) and perfusion ( Q ( M ) ) / oxygenation of vastus lateralis during exercise ; ( ii ) increased levels of CD34 ( + ) / KDR ( + ) / CD117 ( + ) , CD34 ( + ) / KDR ( + ) / CD133 ( + ) , and CD34 ( + ) / KDR ( + ) / CD31 ( + ) cells in blood ; ( iii ) promoted the proliferative capacity of these CPC subsets , and ( iv ) elevated plasma nitrite/nitrate , stromal cell-derived factor-1 ( SDF-1 ) , matrix metalloproteinase-9 ( MMP-9 ) , and vascular endothelial growth factor-A ( VEGF-A ) concentrations .
RESULTS	Despite the lack of changes in Q ( H ) and the number or proliferative capacity of CD34 ( + ) / KDR ( + ) / CD117 ( + ) or CD34 ( + ) / KDR ( + ) / CD31 ( + ) cells , the NT regimen elevated both Q ( M ) and plasma nitrite/nitrate levels and suppressed the shedding of endothelial cells ( CD34 ( - ) / KDR ( + ) / phosphatidylserine ( + ) cells ) .
CONCLUSIONS	The HT regimen improves cardiac and muscular hemodynamic adaptations , possibly by promoting the mobilization/function of CPCs and the production of angiogenic factors .

###24650839
BACKGROUND	Pharmacist - or nurse-led team care decreases patient blood pressure ( BP ) and cardiovascular disease ( CVD ) risk .
OBJECTIVE	To evaluate whether a Web-based dietitian-led ( WD ) team care intervention was feasible and resulted in decreased BP , CVD risk , and weight compared to usual care ( UC ) .
METHODS	Electronic health record ( EHR ) data identified patients aged 30-69 years with BMI > 26 , elevated BP , and 10 % -25 % 10-year Framingham CVD risk who were registered patient website users .
METHODS	Patients with uncontrolled BP at screening were randomized to UC or WD , which included a home BP monitor , scale , and dietitian team care .
METHODS	WD participants had a single in-person dietitian visit to obtain baseline information and create a plan to reduce CVD risk .
METHODS	Planned follow-up occurred via secure messaging to report BP , weight , and fruit and vegetable intake and receive ongoing feedback .
METHODS	If needed , dietitians encouraged patients and their physicians to intensify antihypertensive and lipid-lowering medications .
METHODS	Primary outcomes were change in systolic BP and weight loss 4 kg at 6 months .
METHODS	Feasibility outcomes included intervention utilization and satisfaction .
RESULTS	Between 2010 and 2011 , a total of 90 of 101 participants completed 6-month follow-ups .
RESULTS	The WD group had higher rates of secure messaging utilization and patient satisfaction .
RESULTS	The WD group lost significantly more weight than the UC group ( adjusted net difference = -3.2 kg , 95 % CI = -5.0 , -1.5 , p < 0.001 ) and was more likely to lose 4 kg ( adjusted relative risk [ RRadj ] = 2.96 , 95 % CI = 1.16 , 7.53 ) .
RESULTS	BP control and CVD risk reduction were greater in WD than UC , but differences were not statistically significant .
CONCLUSIONS	WD intervention was feasible and resulted in decreased weight , BP , and CVD risk .
CONCLUSIONS	A larger trial is justified .
BACKGROUND	Trial Registration Number : NCT01077388 .

###25887096
OBJECTIVE	Adult attention-deficit/hyperactivity disorder ( ADHD ) is prevalent but often unrecognized , in part because it tends to co-occur with other disorders such as substance use disorders .
OBJECTIVE	Cocaine use disorder is one such disorder with high co-occurrence of ADHD .
OBJECTIVE	To examine whether treatment of co-occurring ADHD and cocaine use disorder with extended-release mixed amphetamine salts is effective at both improving ADHD symptoms and reducing cocaine use .
METHODS	Thirteen-week , randomized , double-blind , 3-arm , placebo-controlled trial of participants meeting DSM-IV-TR criteria for both ADHD and cocaine use disorder conducted between December 1 , 2007 , and April 15 , 2013 , at 2 academic health center substance abuse treatment research sites .
METHODS	One hundred twenty-six adults diagnosed as having comorbid ADHD and cocaine use disorder were randomized to extended-release mixed amphetamine salts or placebo .
METHODS	Analysis was by intent-to-treat population .
METHODS	Participants received extended-release mixed amphetamine salts ( 60 or 80 mg ) or placebo daily for 13 weeks and participated in weekly individual cognitive behavioral therapy .
METHODS	For ADHD , percentage of participants achieving at least a 30 % reduction in ADHD symptom severity , measured by the Adult ADHD Investigator Symptom Rating Scale ; for cocaine use , cocaine-negative weeks ( by self-report of no cocaine use and weekly benzoylecgonine urine screens ) during maintenance medication ( weeks 2-13 ) and percentage of participants achieving abstinence for the last 3 weeks .
RESULTS	More patients achieved at least a 30 % reduction in ADHD symptom severity in the medication groups ( 60 mg : 30 of 40 participants [ 75.0 % ] ; odds ratio [ OR ] = 5.23 ; 95 % CI , 1.98-13 .85 ; P < .001 ; and 80 mg : 25 of 43 participants [ 58.1 % ] ; OR = 2.27 ; 95 % CI , 0.94-5 .49 ; P = .07 ) compared with placebo ( 17 of 43 participants [ 39.5 % ] ) .
RESULTS	The odds of a cocaine-negative week were higher in the 80-mg group ( OR = 5.46 ; 95 % CI , 2.25-13 .27 ; P < .001 ) and 60-mg group ( OR = 2.92 ; 95 % CI , 1.15-7 .42 ; P = .02 ) compared with placebo .
RESULTS	Rates of continuous abstinence in the last 3 weeks were greater for the medication groups than the placebo group : 30.2 % for the 80-mg group ( OR = 11.87 ; 95 % CI , 2.25-62 .62 ; P = .004 ) and 17.5 % for the 60-mg group ( OR = 5.85 ; 95 % CI , 1.04-33 .04 ; P = .04 ) vs 7.0 % for placebo .
CONCLUSIONS	Extended-release mixed amphetamine salts in robust doses along with cognitive behavioral therapy are effective for treatment of co-occurring ADHD and cocaine use disorder , both improving ADHD symptoms and reducing cocaine use .
CONCLUSIONS	The data suggest the importance of screening and treatment of ADHD in adults presenting with cocaine use disorder .
BACKGROUND	clinicaltrials.gov Identifier : NCT00553319 .

###25140986
OBJECTIVE	We previously reported on a randomized controlled trial ( RCT ) that examined the effect of adding tobramycin to bone cement after femoral stem migration .
OBJECTIVE	The present study examined femoral head penetration into both conventional and highly crosslinked polyethylene acetabular liners in the same group of RCT patients , with a minimum of 5 years of postoperative follow-up .
METHODS	Linear penetration of the femoral head into an X3 ( Stryker ) crosslinked polyethylene ( XLPE ) liner was measured in 18 patients ( 19 hips ) using radiostereometric analysis ( RSA ) .
METHODS	Femoral head penetration was also measured in 6 patients ( 6 hips ) with a conventional polyethylene liner ( CPE ) , which served as a control group .
RESULTS	The median proximal femoral head penetration in the XLPE group after 5.5 years was 0.025 mm with a steady-state penetration rate of 0.001 mm/year between year 1 and year 5 .
RESULTS	The CPE liner showed a median proximal head penetration of 0.274 mm after 7.2 years , at a rate of 0.037 mm/year .
CONCLUSIONS	The Trident X3 sequentially annealed XLPE liner shows excellent in vivo wear resistance compared to non-crosslinked CPE liners at medium-term implantation .
CONCLUSIONS	The rate of linear head penetration in the XLPE liners after > 5 years of follow-up was 0.001 mm/year , which is in close agreement with the results of previous studies .

###24610884
BACKGROUND	Lowering blood pressure ( BP ) after stroke remains a challenge , even in the context of clinical trials .
BACKGROUND	The Secondary Prevention of Small Subcortical Strokes ( SPS3 ) BP protocol , BP management during the study , and achieved BPs are described here .
METHODS	Patients with recent symptomatic lacunar stroke were randomized to 1 of 2 levels of systolic BP ( SBP ) targets : lower : < 130mm Hg , or higher : 130-149mm Hg .
METHODS	SBP management over the course of the trial was examined by race/ethnicity and other baseline conditions .
RESULTS	Mean SBP decreased for both groups from baseline to the last follow-up , from 142.4 to 126.7 mm Hg for the lower SBP target group and from 143.6 to 137.4 mm Hg for the higher SBP target group .
RESULTS	At baseline , participants in both groups used an average of 1.71.2 antihypertensive medications , which increased to a mean of 2.41.4 ( lower group ) and 1.81.4 ( higher group ) by the end-study visit .
RESULTS	It took an average of 6 months for patients to reach their SBP target , sustained to the last follow-up .
RESULTS	Black participants had the highest proportion of SBP 150mm Hg at both study entry ( 40 % ) and end-study visit ( 17 % ) , as compared with whites ( 9 % ) and Hispanics ( 11 % ) .
CONCLUSIONS	These results show that it is possible to safely lower BP even to a SBP goal < 130mm Hg in a variety of patients and settings , including private and academic centers in multiple countries .
CONCLUSIONS	This provides further support for protocol-driven care in lowering BP and consequently reducing the burden of stroke .

###24373195
OBJECTIVE	It is generally accepted that patients prefer to be told the truth by their physicians ; however , the practice of partial truth-telling is frequent with an existing ` norm of nondisclosure . '
OBJECTIVE	Our primary objective was to determine what patients wanted to be told about their illness , and whether there might be differences between patients with either cancer or advanced chronic obstructive pulmonary disease ( COPD ) .
OBJECTIVE	A second objective was to determine how these patients envisioned their participation , or lack thereof , in the treatment decision-making process .
METHODS	Subjects were eligible for this prospective study if they were attending the oncology or pulmonary outpatient consultation services at the British Hospital or the Sanatorio Gemes Private Hospital in Buenos Aires , Argentina between June 2009 and May 2010 .
RESULTS	Ninety-nine patients were recruited .
RESULTS	Forty-four had a diagnosis of COPD , and 55 patients had cancer .
RESULTS	Seventeen of the patients expected their health to improve in the future , but a significantly higher proportion of patients with malignant disorders expected to get better in the near future as compared with those with COPD ( 98.2 % vs 62.8 % , P < 0.001 ) .
RESULTS	Most study participants expressed a desire to receive all the information available about their condition .
RESULTS	A majority of the participants expressed a preference for making treatment decisions in collaboration with their physician ( 40.4 % )
CONCLUSIONS	While they considered the role of their families relevant and wanted information to be shared so that family members might participate in decision-making , they did not want their families to have a right to withhold information , make final decisions .

###26070699
OBJECTIVE	We sought to determine if insulin detemir ( IDet ) is noninferior to insulin neutral protamine Hagedorn ( NPH ) for the treatment of gestational diabetes mellitus ( GDM ) and type 2 diabetes mellitus ( T2DM ) in pregnancy .
METHODS	We conducted a randomized , controlled noninferiority trial of women with GDM and T2DM who entered our Diabetes in Pregnancy Program from March 2013 through October 2014 .
METHODS	Exclusion criteria were type 1 diabetes , age < 18 years , and insulin allergy .
METHODS	Women who failed to achieve good glycemic control ( GC ) ( mean blood glucose [ BG ] < 100 mg/dL ) on diet and/or hypoglycemic agents were randomized to receive either IDet or NPH , with short-acting insulin aspart added as needed .
METHODS	Patients were instructed to test BG 4 times a day ( fasting and 2-hour postprandial ) .
METHODS	Targets of GC were fasting BG < 90 mg/dL and postprandial BG < 120 mg/dL , and insulin was adjusted as needed to achieve the targets .
METHODS	The primary outcome was overall mean BG during insulin treatment ; secondary outcomes included overall mean postprandial and fasting BG , median number of weeks to achieve GC , percent of patients with overall GC , maternal weight gain , perinatal/neonatal outcomes , and number of hypoglycemic events .
METHODS	Power analysis ( 90 % power ) determined that 88 patients would need to be randomized , assuming a maximal acceptable difference in overall mean BG of 7 mg/dL ( SD 10 mg/dL ) .
METHODS	A per protocol analysis was performed .
RESULTS	In all , 105 women were randomized .
RESULTS	Eighteen women were excluded leaving 87 participants for analysis ( 45 NPH , 42 IDet ) .
RESULTS	Maternal characteristics were similar in both groups .
RESULTS	The difference in the mean BG of the groups was 2.1 mg/dL with a 1-sided upper 95 % confidence limit of 5.5 mg/dL ( less than the maximal acceptable difference of 7 mg/dL ; P = .2937 ) .
RESULTS	There was no significant difference in the primary outcome when an intent-to-treat analysis was performed or when the T2DM patients were excluded .
RESULTS	The time to achieve GC was similar in both groups .
RESULTS	There were no differences in perinatal outcomes and maternal weight gain among the groups .
RESULTS	There were more hypoglycemic events per patient in the NPH group .
CONCLUSIONS	IDet is noninferior to insulin NPH for the treatment of GDM and T2DM in pregnancy .

###25946480
BACKGROUND	Transfusion-related acute lung injury incidence remains the leading cause of posttransfusion mortality .
BACKGROUND	The etiology may be related to leukocyte antibodies or biologically active compounds in transfused plasma , injuring susceptible recipient 's lungs .
BACKGROUND	The authors have hypothesized that transfusion could have less severe effects that are not always appreciated clinically and have shown subtly decreased pulmonary oxygen gas transfer in healthy volunteers after transfusion of fresh and 21-day stored erythrocytes .
BACKGROUND	In this study , the authors tested the same hypothesis in surgical patients .
METHODS	Ninety-one patients undergoing elective major spine surgery with anticipated need for erythrocyte transfusion were randomly allocated to receive their first transfusion of erythrocytes as cell salvage ( CS ) , washed stored , or unwashed stored .
METHODS	Clinicians were not blinded to group assignment .
METHODS	Pulmonary gas transfer and mechanics were measured 5 min before and 30 min after erythrocyte transfusion .
RESULTS	The primary outcome variable , gas transfer , as assessed by change of PaO2/FIO2 , with erythrocyte transfusion was not significant in any group ( mean SD ; CS : 9 59 ; washed : 10 26 ; and unwashed : 15 1 ) and did not differ among groups ( P = 0.92 ) .
RESULTS	Pulmonary dead space ( VD/VT ) decreased with CS transfusion ( -0.01 0.04 ; P = 0.034 ) but did not change with other erythrocytes ; the change from before to after erythrocyte transfusion did not differ among groups ( -0.01 to +0.01 ; P = 0.28 ) .
CONCLUSIONS	The authors did not find impaired gas exchange as assessed by PaO2/FIO2 with transfused erythrocytes that did or did not contain nonautologous plasma .
CONCLUSIONS	This clinical trial did not support the hypothesis of erythrocyte transfusion-induced gas exchange deficit that had been found in healthy volunteers .

###24320906
BACKGROUND	Dentinal hypersensitivity is a common problem and there is a growing interest in herbal based formulations for the treatment of oral diseases .
BACKGROUND	This study was conducted to assess the efficacy of a commercially available novel herbal dentifrice in reduction of dentinal hypersensitivity .
METHODS	A total of 73 subjects ( 38 males and 35 females ; aged 25-60years ) were randomly divided into two groups : Group 1 - a placebo dentifrice ( The Himalaya Drug Company Research and Development , Makali , Bangalore ) and Group 2 - ( test group ) , a commercially available herbal dentifrice ( Hi Ora K , The Himalaya Drug Company Research and Development , Makali , Bangalore ) .
METHODS	Sensitivity scores for controlled air stimulus and cold water were recorded at baseline , 6weeks and 12weeks .
RESULTS	The test group was found to be significantly better compared to the placebo group at the end of 6 and 12weeks in reduction of dentinal hypersensitivity .
CONCLUSIONS	The novel herbal dentifrice can be recommended for treatment of dentinal hypersensitivity .

###24420962
BACKGROUND	Peripheral neuropathic pain ( PNP ) associated with allodynia poses a significant clinical challenge .
BACKGROUND	The efficacy of ( 9 ) - tetrahydrocannabinol/cannabidiol ( THC/CBD ) oromucosal spray , a novel cannabinoid formulation , was investigated in this 15-week randomized , double-blind , placebo-controlled parallel group study .
METHODS	In total , 303 patients with PNP associated with allodynia were screened ; 128 were randomized to THC/CBD spray and 118 to placebo , in addition to their current analgesic therapy .
METHODS	The co-primary efficacy endpoints were the 30 % responder rate in PNP 0-10 numerical rating scale ( NRS ) score and the mean change from baseline to the end of treatment in this score .
METHODS	Various key secondary measures of pain and functioning were also investigated .
RESULTS	At the 30 % responder level , there were statistically significant treatment differences in favour of THC/CBD spray in the full analysis ( intention-to-treat ) dataset [ p = 0.034 ; 95 % confidence interval ( CI ) : 1.05-3 .70 ] .
RESULTS	There was also a reduction in mean PNP 0-10 NRS scores in both treatment groups that was numerically higher in the THC/CBD spray group , but which failed to reach statistical significance .
RESULTS	Secondary measures of sleep quality 0-10 NRS score ( p = 0.0072 ) and Subject Global Impression of Change ( SGIC ) ( p = 0.023 ) also demonstrated statistically significant treatment differences in favour of THC/CBD spray treatment .
CONCLUSIONS	These findings demonstrate that , in a meaningful proportion of otherwise treatment-resistant patients , clinically important improvements in pain , sleep quality and SGIC of the severity of their condition are obtained with THC/CBD spray .
CONCLUSIONS	THC/CBD spray was well tolerated and no new safety concerns were identified .

###25023385
BACKGROUND	Cerebral palsy ( CP ) and brain injury ( BI ) are common conditions that have devastating effects on a child 's ability to use their hands .
BACKGROUND	Hand splinting and task-specific training are two interventions that are often used to address deficits in upper limb skills , both in isolation or concurrently .
BACKGROUND	The aim of this paper is to describe the method to be used to conduct two randomised controlled trials ( RCT ) investigating ( a ) the immediate effect of functional hand splints , and ( b ) the effect of functional hand splints used concurrently with task-specific training compared to functional hand splints alone , and to task-specific training alone in children with CP and BI .
BACKGROUND	The Cognitive Orientation to Occupational Performance ( CO-OP ) approach will be the task-specific training approach used .
METHODS	Two concurrent trials ; a two group , parallel design , RCT with a sample size of 30 participants ( 15 per group ) ; and a three group , parallel design , assessor blinded , RCT with a sample size of 45 participants ( 15 per group ) .
METHODS	age 4-15 years ; diagnosis of CP or BI ; Manual Abilities Classification System ( MACS ) level I - IV ; hand function goals ; impaired hand function ; the cognitive , language and behavioural ability to participate in CO-OP .
METHODS	Participants will be randomly allocated to one of 3 groups ; ( 1 ) functional hand splint only ( n = 15 ) ; ( 2 ) functional hand splint combined with task-specific training ( n = 15 ) ; ( 3 ) task-specific training only ( n = 15 ) .
METHODS	Allocation concealment will be achieved using sequentially numbered , sealed opaque envelopes opened by an off-site officer after baseline measures .
METHODS	Treatment will be provided for a period of 2 weeks , with outcome measures taken at baseline , 1 hour after randomisation , 2 weeks and 10 weeks .
METHODS	The functional hand splint will be a wrist cock-up splint ( + / - thumb support or supination strap ) .
METHODS	Task-specific training will involve 10 sessions of CO-OP provided in a group of 2-4 children .
METHODS	Primary outcome measures will be the Canadian Occupational Performance Measure ( COPM ) and the Goal Attainment Scale ( GAS ) .
METHODS	Analysis will be conducted on an intention-to-treat basis .
CONCLUSIONS	This paper outlines the protocol for two randomised controlled trials investigating functional hand splints and CO-OP for children with CP and BI .

###24456128
BACKGROUND	The nipple-areolar complex ( NAC ) has special histological properties with higher melanocyte concentration than breast skin .
BACKGROUND	To date , there are no data describing the late effects on the NAC following breast-conserving therapy ( BCT ) .
BACKGROUND	This study evaluated colour changes in the NAC in patients treated with breast-conserving surgery and adjuvant radiotherapy after 5 years .
METHODS	Digital photographs obtained at 5 years following breast irradiation from the St. George and Wollongong ( SGW ) trial ( NCT00138814 ) were evaluated by five experts using an iPad ( Apple Inc. , Cupertino , CA , USA ) application specifically created for this study .
METHODS	The SGW trial randomised 688 patients with Tis-2 , N0-1 , M0 carcinoma to the control arm of 50Gy in 25 fractions and boost arm of 45Gy in 25 fractions and 16Gy in 8 fractions electron boost .
RESULTS	A total of 141/372 ( 38 % ) patients had altered NAC ( 86 % lighter , 10 % darker ) .
RESULTS	Patients with Celtic skin type had increased likelihood of having an altered NAC ( odds ratio ( OR ) , 1.75 ( CI 1.1-2 .7 , P = 0.011 ) ) .
RESULTS	On subgroup analysis , those with Celtic skin type receiving biologically equivalent dose ( BED ) Gy3 80Gy had OR of 3.03 ( 95 % CI 1.2-7 .5 , P = 0.016 ) for having altered colour .
RESULTS	There was a dose response with more profound changes seen in the NAC compared with irradiated breast skin if BED Gy3 80Gy with OR of 2.42 ( 95 % CI 1.1-5 .6 , P = 0.036 ) .
CONCLUSIONS	In this Caucasian BCT population , over 30 % of patients developed lighter NAC and more commonly in women with Celtic skin type .
CONCLUSIONS	The degree of this effect increased with higher radiation dose .

###25205864
OBJECTIVE	Substantial progress has been made in identifying susceptibility variants for AMD in European populations ; however , few studies have been conducted to understand the role these variants play in AMD risk in diverse populations .
OBJECTIVE	The present study aims to examine AMD risk across diverse populations in known and suspected AMD complement factor and lipid-related loci .
METHODS	Targeted genotyping was performed across study sites for AMD and lipid trait-associated single nucleotide polymorphism ( SNPs ) .
METHODS	Genetic association tests were performed at individual sites and then meta-analyzed using logistic regression assuming an additive genetic model stratified by self-described race/ethnicity .
METHODS	Participants included cases with early or late AMD and controls with no signs of AMD as determined by fundus photography .
METHODS	Populations included in this study were European Americans , African Americans , Mexican Americans , and Singaporeans from the Population Architecture using Genomics and Epidemiology ( PAGE ) study .
RESULTS	Index variants of AMD , rs1061170 ( CFH ) and rs10490924 ( ARMS2 ) , were associated with AMD at P = 3.0510 ( -8 ) and P = 6.3610 ( -6 ) , respectively , in European Americans .
RESULTS	In general , none of the major AMD index variants generalized to our non-European populations with the exception of rs10490924 in Mexican Americans at an uncorrected P value < 0.05 .
RESULTS	Four lipid-associated SNPS ( LPL rs328 , TRIB1 rs6987702 , CETP rs1800775 , and KCTD10/MVK rs2338104 ) were associated with AMD in African Americans and Mexican Americans ( P < 0.05 ) , but these associations did not survive strict corrections for multiple testing .
CONCLUSIONS	While most associations did not generalize in the non-European populations , variants within lipid-related genes were found to be associated with AMD .
CONCLUSIONS	This study highlights the need for larger well-powered studies in non-European populations .

###25168404
OBJECTIVE	( 1 ) The primary objectives were ( 1 ) to assess the response to intravenous ( IV ) fluid in children presenting to the ED with migraine and ; ( 2 ) to assess the effect of treatment expectation on the response to I.
BACKGROUND	Despite a lack of evidence for the practice , many emergency department ( ED ) migraine treatment protocols include a bolus of IV fluid .
BACKGROUND	This study assessed the overall response to IV fluid hydration and the effect of expected medication treatment on the pain response among children and adolescents with migraine in an urban ED .
METHODS	A single-blind , randomized parallel arm trial of 10mL/kg IV 0.9 % sodium chloride for children and adolescents aged 5-17 years presenting to a pediatric ED with migraine .
METHODS	Patients were randomized into group A ( no expectation of medication in combination with IV fluid ) and group B ( expectation that medication may be given simultaneously ) .
METHODS	All participants were treated with standard care following the 30-minute assessment .
RESULTS	Forty-seven participants were randomized and 2 were excluded ; mean age was 13.3 years and 31 ( 67.4 % ) were females .
RESULTS	Demographics and baseline characteristics were similar between groups .
RESULTS	Overall , there was no statistically significant difference for the primary outcome - change from baseline on the visual analog scale ( VAS ) at 30 minutes with a mean change of -12.3 mm ( standard deviation [ SD ] 17.9 ) in group A and -12.7 mm ( SD 13.2 ) in group B ( P = .936 ) .
RESULTS	The standardized difference between the 2 means ( Cohen 's d effect size ) was low at 0.024 ( 95 % confidence interval [ CI ] -0.56 to 0.61 ) .
RESULTS	Overall , complete headache relief was observed in only 1 participant ; 16 of 45 ( 35.6 % ; 95 % CI 21.8 to 51.2 ) had a reduction in headache of 33 % or more and 8 of 45 ( 17.8 % ; 95 % CI 6.1 to 29.4 % ) had a minimum clinical significant difference of 30mm or more on VAS with 4 in each group .
RESULTS	Thirteen of 39 patients with follow-up data ( 33.3 % ; 95 % CI 19.1 to 50.2 % ) reported a moderate or severe headache at the 24-hour follow up with no difference between groups ; only 3 patients returned to the ED .
RESULTS	One participant reported a minor IV-related adverse event .
CONCLUSIONS	The overall decrease in pain with IV fluid is small and clinically insignificant .
CONCLUSIONS	Treatment expectation did not significantly influence headache relief at 30 minutes with IV fluid hydration in children or adolescents with migraine in the ED .
CONCLUSIONS	The average relief of headache with IV fluid alone was small ; however , a clinically meaningful response was observed in 17.8 % .
CONCLUSIONS	Recurrence of headache is common in 33 % after ED discharge .

###24346596
BACKGROUND	Combination diphtheria-tetanus-5 component acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine ( DTaP5-IPV-Hib-HepB ) administered either concurrently with 7-valent pneumococcal conjugate vaccine ( PCV7 ) or 1 month apart was generally safe and immunogenic at 2 , 4 and 6 months of age .
BACKGROUND	This study examined the effects of a booster dose at age 15 months .
METHODS	Participants were randomized to DTaP5-IPV-Hib-HepB plus PCV7 , DTaP5-IPV-Hib-HepB with PCV7 administered 1 month later or a pentavalent DTaP5-IPV/Hib plus HepB plus PCV7 at 15 months of age in a randomized , open-label , phase IIb clinical trial .
METHODS	Immunogenicity endpoints were rates of seroresponse to pertussis toxoid , filamentous hemagglutinin , pertactin and fimbriae types 2 and 3 ; rates of seroprotection against ( Hib ) polyribosylribitol phosphate capsular polysaccharide , hepatitis B surface antigen , diphtheria toxoid , tetanus toxoid and poliovirus types 1 , 2 and 3 ; and geometric mean titers to all vaccine antigens .
METHODS	Safety endpoints included solicited injection-site reactions and systemic and serious adverse events .
RESULTS	Seroresponse/seroprotection rates for all antigens exceeded prespecified criteria in both groups that received the hexavalent DTaP5-IPV-Hib-HepB ; in the group that received the currently licensed pentavalent vaccine , seroresponse/seroprotection rates exceeded the criteria for all antigens except filamentous hemagglutinin .
RESULTS	Seroresponse rates were 88.9 % for pertussis antigens and seroprotection rates against polyribosylribitol phosphate capsular polysaccharide , hepatitis B surface antigen , diphtheria toxoid , tetanus toxoid and poliovirus antigens were 95.1 % in recipients of DTaP5-IPV-Hib-HepB .
CONCLUSIONS	DTaP5-IPV-Hib-HepB administered concomitantly with PCV7 or 1 month apart at 15 months of age following the infant series was well-tolerated and elicited antibody responses to all vaccine antigens , with no significant interference from concomitant PCV7 administration ( clinicaltrials.gov registration number NCT00362427 ) .

###26356396
OBJECTIVE	Treatment of patients with neurological manifestations of degenerative-dystrophic lesions of the spine must be integrated and optimized from the perspective of pathogenesis .
OBJECTIVE	Antiedematous therapy is an important moment that takes into account the development of localized swelling affected the spinal structures .
OBJECTIVE	We studied the efficacy of L-lysine aescinat in the treatment of patients with discogenic-venous lumbosacral radiculomyelopathy .
METHODS	We analyzed the therapeutic efficacy of antitumor therapy with the drug L-lysine aescinat in 40 patients with discogenic-venous lumbosacral radiculomyelopathy in comparison with a control group of 40 patients treated with conventional therapy in a neurological hospital .
METHODS	The age of the patients ranged from 30 to 60 years .
METHODS	In total , there were 36 ( 45 % ) women and 44 ( 55 % ) men .
METHODS	Herniated discs were visualized by MRI in all patients , attention was drawn to the condition of radicular veins of the cauda equina .
METHODS	We assessed muscle strength of lumbosacral myotomes , their trophicity and state of segmental-conductor apparatus sensitivity with the quantitative determination of the time of vibration of a tuning fork .
CONCLUSIONS	The comparison of neurological status dynamics during treatment of inpatients has shown that neurological symptoms reduce more effectively in patients treated with L - lysine aescinat ( by 75 % during the first 3-5 days ) and in a greater number of the patients ( 77.5 % vs 55 % in the control group ) .
CONCLUSIONS	The authors ' experience has shown that venous micro - and macro-circulation disorders play an important role in the pathogenesis of lower lumbar disk hernia .
CONCLUSIONS	Clinical manifestations of these disorders are segmental and conductive spinal motor disorders in myotomes and sensitivity .
CONCLUSIONS	Quantitative determination of vibration sensitivity ( tuning fork test ) is pathognomonic for radiculomyeloischemia .
CONCLUSIONS	Vein tonics and antiedemics , including L - lysine aescinat as one of the most effective drugs , exert a pathogenetic effect on spondylic and discogenic nervous system disturbances .

###24743444
OBJECTIVE	Intracranial hemorrhage ( ICH ) is a life-threatening complication of anticoagulation .
METHODS	We investigated the rate , outcomes , and predictors of ICH in 14 264 patients with atrial fibrillation from Rivaroxaban Once Daily , Oral , Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation ( ROCKET AF ) .
METHODS	Cox proportional hazards modeling was used .
RESULTS	During 1.94 years ( median ) of follow-up , 172 patients ( 1.2 % ) experienced 175 ICH events at a rate of 0.67 % per year .
RESULTS	The significant , independent predictors of ICH were race ( Asian : hazard ratio , 2.02 ; 95 % CI , 1.39-2 .94 ; black : hazard ratio , 3.25 ; 95 % CI , 1.43-7 .41 ) , age ( 1.35 ; 1.13-1 .63 per 10-year increase ) , reduced serum albumin ( 1.39 ; 1.12-1 .73 per 0.5 g/dL decrease ) , reduced platelet count below 21010 ( 9 ) / L ( 1.08 ; 1.02-1 .13 per 1010 ( 9 ) / L decrease ) , previous stroke or transient ischemic attack ( 1.42 ; 1.02-1 .96 ) , and increased diastolic blood pressure ( 1.17 ; 1.01-1 .36 per 10 mm Hg increase ) .
RESULTS	Predictors of a reduced risk of ICH were randomization to rivaroxaban ( 0.60 ; 0.44-0 .82 ) and history of congestive heart failure ( 0.65 ; 0.47-0 .89 ) .
RESULTS	The ability of the model to discriminate individuals with and without ICH was good ( C-index , 0.69 ; 95 % CI , 0.64-0 .73 ) .
CONCLUSIONS	Among patients with atrial fibrillation treated with anticoagulation , the risk of ICH was higher among Asians , blacks , the elderly , and in those with previous stroke or transient ischemic attack , increased diastolic blood pressure , and reduced platelet count or serum albumin at baseline .
CONCLUSIONS	The risk of ICH was significantly lower in patients with heart failure and in those who were randomized to rivaroxaban instead of warfarin .
CONCLUSIONS	The external validity of these findings requires testing in other atrial fibrillation populations .

###25037695
BACKGROUND	Efficacy and safety of alirocumab were compared with ezetimibe in hypercholesterolemic patients at moderate cardiovascular risk not receiving statins or other lipid-lowering therapy .
METHODS	In a Phase 3 , randomized , double-blind , double-dummy study ( NCT01644474 ) , patients ( low-density lipoprotein cholesterol [ LDL-C ] 100-190 mg/dL , 10-year risk of fatal cardiovascular events 1 % - < 5 % [ systemic coronary risk estimation ] ) were randomized to ezetimibe 10mg/day ( n = 51 ) or alirocumab 75 mg subcutaneously ( via 1-mL autoinjector ) every 2 weeks ( Q2W ) ( n = 52 ) , with dose up-titrated to 150 mg Q2W ( also 1 mL ) at week 12 if week 8 LDL-C was 70 mg/dL .
METHODS	Primary endpoint was mean LDL-C % change from baseline to 24 weeks , analyzed using all available data ( intent-to-treat approach , ITT ) .
METHODS	Analyses using on-treatment LDL-C values were also conducted .
RESULTS	Mean ( SD ) baseline LDL-C levels were 141.1 ( 27.1 ) mg/dL ( alirocumab ) and 138.3 ( 24.5 ) mg/dL ( ezetimibe ) .
RESULTS	The 24-week treatment period was completed by 85 % of alirocumab and 86 % of ezetimibe patients .
RESULTS	Least squares mean ( SE ) LDL-C reductions were 47 ( 3 ) % with alirocumab versus 16 ( 3 ) % with ezetimibe ( ITT ; p < 0.0001 ) and 54 ( 2 ) % versus 17 ( 2 ) % ( on-treatment ; p < 0.0001 ) .
RESULTS	At week 12 , before up-titration , alirocumab 75 mg Q2W reduced LDL-C by 53 ( 2 ) % ( on-treatment ) .
RESULTS	Injection site reactions were infrequent ( < 2 % and < 4 % of alirocumab and ezetimibe patients , respectively ) .
CONCLUSIONS	Alirocumab demonstrated significantly greater LDL-C lowering versus ezetimibe after 24 weeks with the lower 75 mg Q2W dose sufficient to provide 50 % LDL-C reduction in the majority of the patients .
CONCLUSIONS	Adverse events were comparable between groups .

###25396407
BACKGROUND	Diabetes is a chronic , potentially debilitating , and often fatal disease .
BACKGROUND	Dietary strategies to reduce postprandial glycemia are important in the prevention and treatment of diabetes .
BACKGROUND	Nuts are rich in mono - and polyunsaturated fatty acids , which may reduce hyperglycemia and improve metabolism .
OBJECTIVE	To evaluate the effectiveness of pistachio nut supplementation on glycemic and inflammatory measures in patients with type 2 diabetes .
METHODS	In this double-blind , randomized , placebo-controlled , crossover trial , 48 diabetic patients were equally assigned to groups A and B. Patients in group A received a snack of 25 g pistachio nuts twice a day for 12 weeks and group B received a control meal without nuts .
METHODS	After 12 weeks of intervention , the patients had an 8-week washout .
METHODS	Then the groups were displaced , and group B received the same amount of pistachios for 12 weeks .
RESULTS	With respect to the total change in variables over both phases , there was a marked decrease in HbA1c ( -0.4 % ) and fasting blood glucose ( FBG ) concentrations ( -16 mg/dl ) in the pistachio group compared with the control group ( p 0.001 for both ) .
RESULTS	There was no overall significant change in BMI , blood pressure , HOMA-IR , and C-reactive protein ( CRP ) concentrations .
RESULTS	Analysis of the two phases separately showed a decrease in FBG by 14 mg/dl and in HbA1c by 0.45 % in the treatment group ( A ) after 12 weeks , while no significant differences were seen in group B ( control group ) .
RESULTS	In the second phase , FBG decreased from 151.36 39.22 to 137.28 28.65 mg/dl ( -14 mg/dl ) and HbA1c decreased from 7.42 0.97 to 7.15 0.68 mg/dl ( -0.28 % , p = 0.013 and p = 0.033 , respectively ) in the pistachio group ( B ) .
RESULTS	Pistachio consumption reduced systolic blood pressure ( p = 0.007 ) , BMI ( p = 0.011 ) , and CRP ( p = 0.002 ) in patients from the treatment groups , but not insulin resistance .
CONCLUSIONS	Dietary consumption of pistachio nuts as a snack has beneficial effects on glycemic control , blood pressure , obesity , and inflammation markers in diabetic patients .

###25391549
OBJECTIVE	A hydrocodone extended-release ( ER ) formulation employing the CIMA ( ) Abuse-Deterrence Technology platform was developed to provide resistance against rapid release of hydrocodone when tablets are comminuted or taken with alcohol .
OBJECTIVE	This study evaluated the pharmacokinetics of three hydrocodone ER tablet prototypes with varying levels of polymer coating to identify the prototype expected to have the greatest abuse deterrence potential based on pharmacokinetic characteristics that maintain systemic exposure to hydrocodone comparable to that of a commercially available hydrocodone immediate-release ( IR ) product .
METHODS	In this four-period crossover study , healthy subjects aged 18-45 years were randomized to receive a single intact , oral 45-mg tablet of one of three hydrocodone ER prototypes ( low - , intermediate - , or high-level coating ) or an intact , oral tablet of hydrocodone IR/acetaminophen ( APAP ) 10/325 mg every 6 h until four tablets were administered , with each of the four treatments administered once over the four study periods .
METHODS	Dosing periods were separated by a minimum 5-day washout .
METHODS	Naltrexone 50 mg was administered to block opioid receptors .
METHODS	Blood samples for pharmacokinetic assessments were collected predose and through 72 h postdose .
METHODS	Parameters assessed included maximum observed plasma hydrocodone concentration ( C ( max ) ) , time to C ( max ) ( t ( max ) ) , and area under the concentration-time curve from time 0 to infinity ( AUC ( 0 - ) ) .
RESULTS	Mean C ( max ) values were 49.2 , 32.6 , and 28.4 ng/mL for the low - , intermediate - , and high-level coating hydrocodone ER tablet prototypes , respectively , and 37.3 ng/mL for the hydrocodone IR/APAP tablet ; respective median t ( max ) values were 5.9 , 8.0 , 8.0 , and 1.0 h. Total systemic exposure to hydrocodone ( AUC ( 0 - ) ) was comparable between hydrocodone ER tablet prototypes ( 640 , 600 , and 578 ngh/mL , respectively ) and hydrocodone IR/APAP ( 581 ngh/mL ) .
RESULTS	No serious adverse events or deaths were reported .
RESULTS	The most common adverse events included headache ( 26 % ) and nausea ( 18 % ) .
CONCLUSIONS	All three hydrocodone ER tablet prototypes ( low - , intermediate - , and high-level polymer coating ) demonstrated ER pharmacokinetic characteristics .
CONCLUSIONS	The hydrocodone ER tablet prototype with the high-level coating was selected for development because of its comparable exposure to the hydrocodone IR/APAP formulation and potentially increased ability to resist rapid drug release upon product tampering because of a higher polymer coating level .
CONCLUSIONS	All study medications were well tolerated in healthy naltrexone-blocked volunteers .

###25016597
OBJECTIVE	A low FODMAP ( Fermentable Oligosaccharides , Disaccharides , Monosaccharides And Polyols ) diet reduces symptoms of IBS , but reduction of potential prebiotic and fermentative effects might adversely affect the colonic microenvironment .
OBJECTIVE	The effects of a low FODMAP diet with a typical Australian diet on biomarkers of colonic health were compared in a single-blinded , randomised , cross-over trial .
METHODS	Twenty-seven IBS and six healthy subjects were randomly allocated one of two 21-day provided diets , differing only in FODMAP content ( mean ( 95 % CI ) low 3.05 ( 1.86 to 4.25 ) g/day vs Australian 23.7 ( 16.9 to 30.6 ) g/day ) , and then crossed over to the other diet with 21-day washout period .
METHODS	Faeces passed over a 5-day run-in on their habitual diet and from day 17 to day 21 of the interventional diets were pooled , and pH , short-chain fatty acid concentrations and bacterial abundance and diversity were assessed .
RESULTS	Faecal indices were similar in IBS and healthy subjects during habitual diets .
RESULTS	The low FODMAP diet was associated with higher faecal pH ( 7.37 ( 7.23 to 7.51 ) vs. 7.16 ( 7.02 to 7.30 ) ; p = 0.001 ) , similar short-chain fatty acid concentrations , greater microbial diversity and reduced total bacterial abundance ( 9.63 ( 9.53 to 9.73 ) vs. 9.83 ( 9.72 to 9.93 ) log10 copies/g ; p < 0.001 ) compared with the Australian diet .
RESULTS	To indicate direction of change , in comparison with the habitual diet the low FODMAP diet reduced total bacterial abundance and the typical Australian diet increased relative abundance for butyrate-producing Clostridium cluster XIVa ( median ratio 6.62 ; p < 0.001 ) and mucus-associated Akkermansia muciniphila ( 19.3 ; p < 0.001 ) , and reduced Ruminococcus torques .
CONCLUSIONS	Diets differing in FODMAP content have marked effects on gut microbiota composition .
CONCLUSIONS	The implications of long-term reduction of intake of FODMAPs require elucidation .
BACKGROUND	ACTRN12612001185853 .

###25269885
OBJECTIVE	As compared with individual tablets , saxagliptin/metformin extended-release ( XR ) fixed-dose combination ( FDC ) tablets offer the potential for increased patient compliance with the convenience of once daily dosing .
OBJECTIVE	The aim of the present study was to show that the FDC of saxagliptin and metformin XR is bioequivalent to co-administration of the individual components when given to Chinese subjects residing in China .
METHODS	This was a randomized , open-label , single-dose , two-period , cross-over pharmacokinetic study in two cohorts of healthy adult Chinese male subjects ( n = 32 in each cohort ) under fed conditions .
METHODS	In cohort 1 , the pharmacokinetic properties of a saxagliptin/metformin XR 5/500mg FDC tablet were compared with those of co-administration of a 5mg saxagliptin tablet and a 500mg metformin XR tablet .
METHODS	In cohort 2 , the pharmacokinetic properties of a saxagliptin/metformin XR 5/1 ,000 mg FDC tablet were compared with those of co-administration of a 5mg saxagliptin tablet and 2500mg metformin XR tablets .
METHODS	The two cohorts were independent of each other with respect to treatment and results .
METHODS	The pharmacokinetic properties of the active metabolite of saxagliptin ( 5-hydroxy-saxagliptin ) , as well as the safety and tolerability of each treatment , were also evaluated .
RESULTS	For both cohorts , saxagliptin and metformin in the FDCs were bioequivalent to the individual components , as the limits of the 90 % confidence intervals of the geometric least squares mean ratios were contained within the 80-125 % bioequivalence limits for the area under the plasma concentration-time curve parameters and within the 70-143 % bioequivalence limits for the maximum plasma concentration .
RESULTS	Similar exposures of 5-hydroxy-saxagliptin were observed with the two treatment regimens within each cohort .
RESULTS	Co-administration of saxagliptin and metformin XR was generally safe and well tolerated as the FDCs or as individual tablets .
CONCLUSIONS	Saxagliptin/metformin XR 5/500mg and saxagliptin/metformin XR 5/1 ,000 mg FDCs were bioequivalent to individual tablets of saxagliptin and metformin XR of the same strengths and were generally well tolerated .
CONCLUSIONS	These results in healthy Chinese subjects are consistent with those of previous assessments of saxagliptin/metformin XR FDC in the saxagliptin clinical development programme .

###25006707
OBJECTIVE	To test a virtual case-based Simulated Diabetes Education intervention ( SimDE ) developed to teach primary care residents how to manage diabetes .
METHODS	Nineteen primary care residency programs , with 341 volunteer residents in all postgraduate years ( PGY ) , were randomly assigned to a SimDE intervention group or control group ( CG ) .
METHODS	The Web-based interactive educational intervention used computerized virtual patients who responded to provider actions through programmed simulation models .
METHODS	Eighteen distinct learning cases ( L-cases ) were assigned to SimDE residents over six months from 2010 to 2011 .
METHODS	Impact was assessed using performance on four virtual assessment cases ( A-cases ) , an objective knowledge test , and pre-post changes in self-assessed diabetes knowledge and confidence .
METHODS	Group comparisons were analyzed using generalized linear mixed models , controlling for clustering of residents within residency programs and differences in baseline knowledge .
RESULTS	The percentages of residents appropriately achieving A-case composite clinical goals for glucose , blood pressure , and lipids were as follows : A-case 1 : SimDE = 21.2 % , CG = 1.8 % , P = .002 ; A-case 2 : SimDE = 15.7 % , CG = 4.7 % , P = .02 ; A-case 3 : SimDE = 48.0 % , CG = 10.4 % , P < .001 ; and A-case 4 : SimDE = 42.1 % , CG = 18.7 % , P = .004 .
RESULTS	The mean knowledge score and pre-post changes in self-assessed knowledge and confidence were significantly better for SimDE group than CG participants .
CONCLUSIONS	A virtual case-based simulated diabetes education intervention improved diabetes management skills , knowledge , and confidence for primary care residents .

###24549550
OBJECTIVE	For many older people , long-term functional limitations persist after a hip fracture .
OBJECTIVE	The efficacy of a home exercise program with minimal supervision after formal hip fracture rehabilitation ends has not been established .
OBJECTIVE	To determine whether a home exercise program with minimal contact with a physical therapist improved function after formal hip fracture rehabilitation ended .
METHODS	Randomized clinical trial conducted from September 2008 to October 2012 in the homes of 232 functionally limited older adults who had completed traditional rehabilitation after a hip fracture .
METHODS	The intervention group ( n = 120 ) received functionally oriented exercises ( such as standing from a chair , climbing a step ) taught by a physical therapist and performed independently by the participants in their homes for 6 months .
METHODS	The attention control group ( n = 112 ) received in-home and telephone-based cardiovascular nutrition education .
METHODS	Physical function assessed at baseline , 6 months ( ie , at completion of the intervention ) , and 9 months by blinded assessors .
METHODS	The primary outcome was change in function at 6 months measured by the Short Physical Performance Battery ( SPPB ; range 0-12 , higher score indicates better function ) and the Activity Measure for Post-Acute Care ( AM-PAC ) mobility and daily activity ( range , 23-85 and 9-101 , higher score indicates better function ) .
RESULTS	Among the 232 randomized patients , 195 were followed up at 6 months and included in the primary analysis .
RESULTS	The intervention group ( n = 100 ) showed significant improvement relative to the control group ( n = 95 ) in functional mobility ( mean SPPB scores for intervention group : 6.2 [ SD , 2.7 ] at baseline , 7.2 [ SD , 3 ] at 6 months ; control group : 6.0 [ SD , 2.8 ] at baseline , 6.2 [ SD , 3 ] at 6 months ; and between-group differences : 0.8 [ 95 % CI , 0.4 to 1.2 ] , P < .001 ; mean AM-PAC mobility scores for intervention group : 56.2 [ SD , 7.3 ] at baseline , 58.1 [ SD , 7.9 ] at 6 months ; control group : 56 [ SD , 7.1 ] at baseline , 56.6 [ SD , 8.1 ] at 6 months ; and between-group difference , 1.3 [ 95 % CI , 0.2 to 2.4 ] , P = .03 ; and mean AM-PAC daily activity scores for intervention group : 57.4 [ SD , 13.7 ] at baseline , 61.3 [ SD , 15.7 ] at 6 months ; control group : 58.2 [ SD , 15.2 ] at baseline , 58.6 [ SD , 15.3 ] at 6 months ; and between-group difference , 3.5 [ 95 % CI , 0.9 to 6.0 ] , P = .03 ) .
RESULTS	In multiple imputation analyses , between-group differences remained significant for SPPB and AM-PAC daily activity , but not for mobility .
RESULTS	Significant between-group differences persisted at 9 months for all functional measures with and without imputation .
CONCLUSIONS	Among patients who had completed standard rehabilitation after hip fracture , the use of a home-based functionally oriented exercise program resulted in modest improvement in physical function at 6 months after randomization .
CONCLUSIONS	The clinical importance of these findings remains to be determined .
BACKGROUND	clinicaltrials.gov Identifier : NCT00592813 .

###25123978
OBJECTIVE	To explore any differences in efficacy and safety outcomes between European ( EU ) ( n = 684 ) and North American ( NA ) ( n = 395 ) patients in the AFFIRM trial ( NCT00974311 ) .
METHODS	Phase III , double-blind , placebo-controlled , multinational AFFIRM trial in men with metastatic castration-resistant prostate cancer ( mCRPC ) after docetaxel .
METHODS	Participants were randomly assigned in a 2:1 ratio to receive oral enzalutamide 160mg/day or placebo .
METHODS	The primary end point was overall survival ( OS ) in a post hoc analysis .
RESULTS	Enzalutamide significantly improved OS compared with placebo in both EU and NA patients .
RESULTS	The median OS in EU patients was longer than NA patients in both treatment groups .
RESULTS	However , the relative treatment effect , expressed as hazard ratio and 95 % confidence interval , was similar in both regions : 0.64 ( 0.50 , 0.82 ) for EU and 0.63 ( 0.47 , 0.83 ) for NA .
RESULTS	Significant improvements in other end points further confirmed the benefit of enzalutamide over placebo in patients from both regions .
RESULTS	The tolerability profile of enzalutamide was comparable between EU and NA patients , with fatigue and nausea the most common adverse events .
RESULTS	Four EU patients ( 4/461 enzalutamide-treated , 0.87 % ) and one NA patient ( 1/263 enzalutamide-treated , 0.38 % ) had seizures .
RESULTS	The difference in median OS was related in part to the timing of development of mCRPC and baseline demographics on study entry .
CONCLUSIONS	This post hoc exploratory analysis of the AFFIRM trial showed a consistent OS benefit for enzalutamide in men with mCRPC who had previously progressed on docetaxel in both NA - and EU-treated patients , although the median OS was higher in EU relative to NA patients .
CONCLUSIONS	Efficacy benefits were consistent across end points , with a comparable safety profile in both regions .

###24576720
BACKGROUND	Although opioids are widely used as analgesics in general anaesthesia , they have unpleasant side-effects and can delay postoperative recovery .
BACKGROUND	Acupuncture and related techniques are effective for acute and chronic pain , and reduces some side-effects .
BACKGROUND	We assessed the effect of transcutaneous electric acupoint stimulation ( TEAS ) on intra-operative remifentanil consumption and the incidences of anaesthesia-related side-effects .
METHODS	Sixty patients undergoing sinusotomy were randomly assigned to TEAS or control group .
METHODS	TEAS consisted of 30 min of stimulation ( 6-9 mA , 2/10 Hz ) on the Hegu ( LI4 ) , Neiguan ( PC6 ) , and Zusanli ( ST36 ) before anaesthesia .
METHODS	The patients in the control group had the electrodes applied , but received no stimulation .
METHODS	Bispectral index was used to monitor the depth of anaesthesia .
METHODS	Perioperative haemodynamics were recorded , and peripheral blood samples were collected to measure the levels of mediators of surgical stress .
METHODS	The primary end point was intraoperative remifentanil consumption and the secondary endpoints were recovery quality and anaesthesia-related side-effects .
RESULTS	Patients in the TEAS group required 39 % less remifentanil during surgery than controls [ 0.0907 ( SD 0.026 ) g kg ( -1 ) min ( -1 ) vs 0.051 ( 0.018 ) g kg ( -1 ) min ( -1 ) ] .
RESULTS	There were no differences in intra-operative haemodynamics or surgical stress between groups .
RESULTS	However , the time to extubation and recall in the control group was 16.8 ( 6.8 ) min and 23.0 ( 5.0 ) min , respectively , significantly longer than that in the TEAS group ( P < 0.01 ) .
RESULTS	TEAS also decreased the incidence of dizziness and pruritus within the first 24 h after surgery ( P < 0.01 ) .
CONCLUSIONS	The use of TEAS significantly reduced intra-operative remifentanil consumption and alleviated postoperative side-effects in patients undergoing sinusotomy .
BACKGROUND	The trial was registered at clinicaltrials.gov ( NCT01700855 ) .

###24664649
BACKGROUND	Radial-head subluxation is an easily identified and treated injury .
BACKGROUND	We investigated whether triage nurses in the emergency department can safely reduce radial-head subluxation at rates that are not substantially lower than those of emergency department physicians .
METHODS	We performed an open , noninferiority , cluster-randomized control trial .
METHODS	Children aged 6 years and younger who presented to the emergency department with a presentation consistent with radial-head subluxation and who had sustained a known injury in the previous 12 hours were assigned to either nurse-initiated or physician-initiated treatment , depending on the day .
METHODS	The primary outcome was the proportion of children who had a successful reduction ( return to normal arm usage ) .
METHODS	We used a noninferiority margin of 10 % .
RESULTS	In total , 268 children were eligible for inclusion and 245 were included in the final analysis .
RESULTS	Of the children assigned to receive physician-initiated care , 96.7 % ( 117/121 ) had a successful reduction performed by a physician .
RESULTS	Of the children assigned to receive nurse-treatment care , 84.7 % ( 105/124 ) had a successful reduction performed by a nurse .
RESULTS	The difference in the proportion of successful radial head subluxations between the groups was 12.0 % ( 95 % confidence interval [ CI ] 4.8 % to 19.7 % ) .
RESULTS	Noninferiority of nurse-initiated radial head subluxation was not shown .
CONCLUSIONS	In this trial , the rate of successful radial-head subluxation performed by nurses was inferior to the physician success rate .
CONCLUSIONS	Although the success rate in the nurse-initiated care group did not meet the non-inferiority margin , nurses were able to reduce radial head subluxation for almost 85 % of children who presented with probable radial-head subluxation .
BACKGROUND	Clinical Trials.gov , no .
BACKGROUND	NCT00993954 .

###24304745
BACKGROUND	One in ten people aged between 55 to 74 years have a significant hearing impairment in their better hearing ear ( as defined by audiometric hearing thresholds ) .
BACKGROUND	However , it is becoming increasingly clear that the challenges faced by older listeners can not be explained by the audiogram alone .
BACKGROUND	The ability for people with hearing loss to use cognition to support speech perception allows for compensation of the degraded auditory input .
BACKGROUND	This in turn offers promise for new cognitive-based rehabilitative interventions .
BACKGROUND	Working memory is known to be highly associated with language comprehension and recent evidence has shown significant generalization of learning from trained working memory tasks to improvements in sentence-repetition skills of children with severe to profound hearing loss .
BACKGROUND	This evidence offers support for further investigation into the potential benefits of working memory training to improve speech perception abilities in other hearing impaired populations .
METHODS	This is a double-blind randomized active controlled trial aiming to assess whether a program of working memory training results in improvements in untrained measures of cognition , speech perception and self-reported hearing abilities in adult hearing aid users aged ( 50 to 74 years ) with mild-to-moderate hearing loss hearing aid users , compared with an active control group who receive a placebo version of the working memory training program .
CONCLUSIONS	The present study aims to generate high-quality preliminary evidence for the efficacy of working memory training for adult hearing aid users with mild-to-moderate sensorineural hearing loss who are existing hearing aid users .
CONCLUSIONS	This trial addresses a number of gaps in the published literature assessing training interventions for people with hearing loss , and in the general literature surrounding working memory training , such as the inclusion of an active control group , participant and tester blinding , and increased transparency in reporting .
BACKGROUND	ClinicalTrials.gov identifier : NCT01892007 .
BACKGROUND	Date of registration : 27 June 2013 .

###25869369
OBJECTIVE	To investigate whether a responsive stimulation intervention delivered to caregivers of young children either alone or integrated with nutrition interventions would benefit parenting skills and emotional availability to promote children 's development and growth compared with either a nutrition intervention alone or the usual standard of care .
METHODS	A cluster randomized factorial effectiveness trial was implemented in an impoverished community in Pakistan .
METHODS	The 4 trial arms were control ( usual standard of care ) , responsive stimulation ( responsive care and stimulation ) , enhanced nutrition ( education and multiple micronutrients ) , and a combination of both enriched interventions .
METHODS	The 4 intervention packages were delivered by community health workers to 1489 mother-infant dyads in the first 2 years of life .
METHODS	Parenting skills and emotional availability indexed by mother-child interaction , caregiving environment , knowledge and practices pertaining to early childhood care and feeding , and maternal depressive symptoms were assessed at multiple intervals .
METHODS	An intention-to-treat factorial analysis was conducted .
RESULTS	Intervention groups were comparable at baseline .
RESULTS	Responsive stimulation significantly benefitted parenting skills with large effect sizes on mother-child interaction ( Cohen 's d 0.8 ) , caregiving environment ( Cohen 's d 0.9-1 .0 ) , and knowledge and practices ( Cohen 's d 0.7-1 .1 ) compared with small-modest significant effects as a result of nutrition intervention on mother-child interaction and caregiving environment only ( Cohen 's d 0.4 and 0.2 , respectively ) .
RESULTS	The combined intervention had a small significant effect on decreasing maternal depressive symptoms over time ( Cohen 's d 0-0 .2 ) .
CONCLUSIONS	A responsive stimulation intervention can promote positive caregiving behaviors among impoverished families .
CONCLUSIONS	Additional research is needed on interventions to reduce maternal depressive symptoms .

###25016366
OBJECTIVE	To compare the efficacy of behavior activation ( BA ) + low vision rehabilitation ( LVR ) with supportive therapy ( ST ) + LVR to prevent depressive disorders in patients with age-related macular degeneration ( AMD ) .
METHODS	Single-masked , attention-controlled , randomized , clinical trial with outcome assessment at 4 months .
METHODS	Patients with AMD and subsyndromal depressive symptoms attending retina practices ( n = 188 ) .
METHODS	Before randomization , all subjects had 2 outpatient LVR visits , and were then randomized to in-home BA+LVR or ST+LVR .
METHODS	Behavior activation is a structured behavioral treatment that aims to increase adaptive behaviors and achieve valued goals .
METHODS	Supportive therapy is a nondirective , psychological treatment that provides emotional support and controls for attention .
METHODS	The Diagnostic and Statistical Manual IV defined depressive disorder based on the Patient Health Questionnaire-9 ( primary outcome ) , Activities Inventory , National Eye Institute Vision Function Questionnaire-25 plus Supplement ( NEI-VFQ ) , and NEI-VFQ quality of life ( secondary outcomes ) .
RESULTS	At 4 months , 11 BA+LVR subjects ( 12.6 % ) and 18 ST+LVR subjects ( 23.4 % ) developed a depressive disorder ( relative risk [ RR ] , 0.54 ; 95 % CI , 0.27-1 .06 ; P = 0.067 ) .
RESULTS	In planned adjusted analyses the RR was 0.51 ( 95 % CI , 0.27-0 .98 ; P = 0.04 ) .
RESULTS	A mediational analysis suggested that BA+LVR prevented depression to the extent that it enabled subjects to remain socially engaged .
RESULTS	In addition , BA+LVR was associated with greater improvements in functional vision than ST+LVR , although there was no significant between-group difference .
RESULTS	There was no significant change or between-group difference in quality of life .
CONCLUSIONS	An integrated mental health and low vision intervention halved the incidence of depressive disorders relative to standard outpatient LVR in patients with AMD .
CONCLUSIONS	As the population ages , the number of persons with AMD and the adverse effects of comorbid depression will increase .
CONCLUSIONS	Promoting interactions between ophthalmology , optometry , rehabilitation , psychiatry , and behavioral psychology may prevent depression in this population .

###24600214
BACKGROUND	Both peripheral nerve blocks with sedation or general anesthesia can be used for total knee replacement surgery .
OBJECTIVE	We compared these anesthetic techniques on the postoperative quality of recovery early in elderly patients .
METHODS	In our study , 213 patients who were 65 years old and undergoing total knee replacement were randomized to peripheral nerve blocks ( PNBs ) - lumbar plexus and sciatic - with propofol sedation , or general anesthesia with combined propofol and remifentanil .
METHODS	Blocks were performed using nerve stimulation and 0.35 % ropivacaine .
METHODS	All patients received postoperative multimodal analgesia .
METHODS	Postoperative recovery was assessed at 15 minutes , 40 minutes , 1 day , 3 days , and 7 days after surgery , with the Postoperative Quality of Recovery Scale , in physiological , nociceptive , emotive , modified activities of daily living , modified cognitive , and overall patient perspective domains .
RESULTS	Intraoperative blood pressure and heart rate were more stable with PNBs ( P < 0.001 ) .
RESULTS	The recovery was better with PNBs in physiological ( P < 0.001 ) , emotive ( depression and anxiety ) ( P < 0.001 ) , nociceptive ( pain and nausea ) ( P < 0.001 ) , modified cognitive ( P < 0.001 ) , and all domains recovery ( P < 0.001 ) , but not in activities of daily living ( P = 0.181 ) .
RESULTS	Intraoperative drugs and the postoperative sulfentanil requirement of the PNBs group were lower ( all P < 0.001 ) .
RESULTS	Differences were greatest early after surgery with equivalence by 1 week .
RESULTS	Satisfaction was high and not different between groups ( P = 0.059 ) .
CONCLUSIONS	Lumbar plexus and sciatic blocks with sedation facilitates faster postoperative recovery than general anesthesia , but not at 1 week after total knee replacement in patients who were 65 years or older .
CONCLUSIONS	The trial has been registered at ClinicalTrials.gov .
CONCLUSIONS	( NCT01871012 ) .

###25803648
OBJECTIVE	To perform a pilot study to assess the feasibility of performing a phase III trial of therapeutic hypothermia started early and continued for at least 72 hours in children with severe traumatic brain injury .
METHODS	Multicenter prospective randomized controlled phase II trial .
METHODS	All eight of the PICUs in Australia and New Zealand and one in Canada .
METHODS	Children 1-15 years old with severe traumatic brain injury and who could be randomized within 6 hours of injury .
METHODS	The control group had strict normothermia to a temperature of 36-37C for 72 hours .
METHODS	The intervention group had therapeutic hypothermia to a temperature of 32-33C for 72 hours followed by slow rewarming at a rate compatible with maintaining intracranial pressure and cerebral perfusion pressure .
RESULTS	Of 764 children admitted to PICU with traumatic brain injury , 92 ( 12 % ) were eligible and 55 ( 7.2 % ) were recruited .
RESULTS	There were five major protocol violations ( 9 % ) : three related to recruitment and consent processes and two to incorrect temperature management .
RESULTS	Rewarming took a median of 21.5 hours ( 16-35hr ) and was performed without compromise in the cerebral perfusion pressure .
RESULTS	There was no increase in any complications , including infections , bleeding , and arrhythmias .
RESULTS	There was no difference in outcomes 12 months after injury ; in the therapeutic hypothermia group , four ( 17 % ) had a bad outcome ( pediatric cerebral performance category , 4-6 ) and three ( 13 % ) died , whereas in the normothermia group , three ( 12 % ) had a bad outcome and one ( 4 % ) died .
CONCLUSIONS	Early therapeutic hypothermia in children with severe traumatic brain injury does not improve outcome and should not be used outside a clinical trial .
CONCLUSIONS	Recruitment rates were lower and outcomes were better than expected .
CONCLUSIONS	Conventional randomized controlled trials in children with severe traumatic brain injury are unlikely to be feasible .
CONCLUSIONS	A large international trials group and alternative approaches to trial design will be required to further inform practice .

###26011959
OBJECTIVE	To compare early visual function between patients undergoing phacoemulsification combined with multifocal and accommodative intraocular lens implantation .
METHODS	A total of 112 patients with age-related cataract undergoing phacoemulsification in our hospital were recruited for this study and randomly assigned into multifocal ( 56 eyes ; ZAM00 group ) and accommodative ( 56 eyes ; FLEX group ) intraocular lens groups .
METHODS	Visual acuity and contrast sensitivity were statistically compared between the two groups .
RESULTS	No significant difference was found in uncorrected distant visual acuity between the ZMA00 and FLEX groups at 1 week , or 1 , 3 , and 6 months after operation ( all P > 0.05 ) .
RESULTS	At postoperative 6 months , no statistical significance was noted in distant and intermediate best-corrected visual acuity or in contrast sensitivity between the two groups ( all P > 0.05 ) .
RESULTS	Patients in the ZMA00 group were superior to their counterparts in the FLEX group regarding near best corrected visual acuity , reading speed , and spectacle independence ( all P < 0.05 ) .
CONCLUSIONS	ZMA00 and FLEX IOL implantation can provide excellent distant and intermediate visual acuity for patients with age-related cataract .
CONCLUSIONS	ZMA00 IOL is superior to FLEX in terms of near visual acuity .

###24675035
BACKGROUND	A conformable self-expandable metallic stent was developed to overcome the limitation of previous self-expandable metallic stents .
BACKGROUND	The aim of this study was to evaluate outcomes after placement of conformable covered and uncovered self-expandable metallic stents for palliation of malignant gastroduodenal obstruction .
METHODS	A single-blind , randomized , parallel-group , prospective study were conducted in 4 medical centres between March 2009 and July 2012.134 patients with unresectable malignant gastroduodenal obstruction were assigned to a covered double-layered ( n = 66 ) or uncovered unfixed-cell braided ( n = 68 ) stent placement group .
METHODS	Primary analysis was performed to compare re-intervention rates between two groups .
RESULTS	120 patients were analysed ( 59 in the covered group and 61 in the uncovered group ) .
RESULTS	Overall rates of re-intervention were not significantly different between the two groups : 13/59 ( 22.0 % ) in the covered group vs. 13/61 ( 21.3 % ) in the uncovered group , p = 0.999 .
RESULTS	Stent migration was more frequent in the covered group than in the uncovered group ( p = 0.003 ) .
RESULTS	The tumour ingrowth rate was higher in the uncovered group than in the covered group ( p = 0.016 ) .
CONCLUSIONS	The rates of re-intervention did not significantly differ between the two stents .
CONCLUSIONS	Conformable covered double-layered and uncovered unfixed-cell braided stents were associated with different patterns of stent malfunction .

###24517052
OBJECTIVE	To observe the curative effect of Xinfeng Capsule ( XC ) in treatment of rheumatoid arthritis ( RA ) .
METHODS	Recruited were 80 active RA patients , who were randomly assigned to the normal control group and the treatment group , 40 in each group .
METHODS	All patients received the same routine anti-rheumatic treatment : Methotrexate 10 mg per week ; Diclofenac 50 mg when pain was obvious , twice daily .
METHODS	Patients in the treatment group took XC 3 tablets each time , thrice daily .
METHODS	All treatment lasted for 12 consecutive weeks .
METHODS	Serum iron ( SI ) , serum ferritin ( SF ) , transferrin ( TRF ) ; and RA disease activity index ( DAS-28 ) were detected in all patients .
RESULTS	XC could improve HAQ , DAS-28 , hypersensitive C reactive protein ( hs-CRP ) , prostaglandins A ( PGA ) , erythrocyte sedimentation rate ( ESR ) , number of swelling joints , number of tender joints , and morning stiffness time in acute RA patients , showing statistical difference when compared with those of the control group ( P < 0.01 , P < 0.05 ) .
RESULTS	Compared with the control group , SI , SF , DAS-28 , and TRF significantly decreased in the treatment group ( P < 0.05 ) .
CONCLUSIONS	XC could improve DAS-28 , and SI reserve in patients with active RA , and lower DAS-28 related indicators .

###25151205
OBJECTIVE	Our purpose was to evaluate ertapenem versus ceftriaxone/metronidazole for prophylaxis of surgical site infections ( SSIs ) following elective colorectal surgery in Chinese adult patients .
METHODS	Eligible Chinese adults aged 18-80 years scheduled to undergo elective colorectal surgery by laparotomy were randomized to receive a 30 min infusion of 1 g of ertapenem/metronidazole placebo or 2 g of ceftriaxone/500 mg of metronidazole within 2 h before initial incision .
METHODS	The study endpoint was the proportion of patients with successful prophylaxis at 4 weeks after treatment .
METHODS	The primary analysis was based on the evaluable population ( PP population ) and the pre-specified non-inferiority margin was set at -15 % .
METHODS	ClinicalTrials.gov : NCT01254344 .
RESULTS	Of 599 patients randomized , 499 ( 251 ertapenem and 248 ceftriaxone ) were eligible for inclusion in the PP population .
RESULTS	The proportions of patients with successful prophylaxis in the ertapenem and ceftriaxone groups were 90.4 % ( 227/251 ) and 90.3 % ( 224/248 ) , respectively .
RESULTS	The difference in the proportion of successful outcomes was 0.1 % ( 95 % CI -5.2 % , 5.5 % ) .
RESULTS	Unexplained antibiotic use was the most frequent reason for prophylaxis failure in both groups [ ertapenem 4.8 % ( 12/251 ) , ceftriaxone 4.4 % ( 11/248 ) ; difference 0.3 % ; 95 % CI -3.6 , 4.3 ] .
RESULTS	Pathogen species isolated from SSI sources were consistent with previously conducted studies and the product package insert .
RESULTS	The incidence of adverse events ( AEs ) was similar between the groups , with the most common AE being pyrexia [ ertapenem 7.6 % ( 22/290 ) , ceftriaxone 5.7 % ( 17/297 ) ] .
CONCLUSIONS	Ertapenem is as effective as ceftriaxone/metronidazole for SSI prophylaxis in patients undergoing elective colorectal surgery , and is well tolerated .

###25198030
BACKGROUND	This study evaluates the safety and efficacy of specific sublingual immunotherapy ( SLIT ) against grass pollen allergens in patients > 60 years of age with seasonal allergic rhinitis ( SAR ) and/or asthma .
BACKGROUND	This study sought to assess nasal symptoms during the grass pollen season , reduce medication use , and monitor adverse reactions during immunotherapy .
METHODS	Seventy-eight 60 - to 70-year-old patients with SAR and a confirmed grass pollen allergy according to skin-prick tests , nasal provocation , and measurement of serum IgE were included in the study .
METHODS	The patients were individually randomized to the active or placebo groups using a double-blind method .
METHODS	A total of 41 subjects in the SLIT group ( 5 grass pollen mixture ) and 37 subjects in the placebo group were monitored for 3 years .
METHODS	The patients were required to record each use of an antiallergy medication on a diary card .
RESULTS	Thirty-eight patients completed 3 years ( preseasonal ) of SLIT , and 34 subjects finished the placebo treatment in the same time period .
RESULTS	The total nasal symptom score decreased by 64 % in the active group and 7 % in the placebo group after SLIT .
RESULTS	This difference was only significant in the active group ( p < 0.05 ) .
RESULTS	At the end of therapy , the total medication score of the active group decreased significantly by a maximum of 51 % ( p < 0.05 ) , whereas the total medication score of the placebo group had an insignificant decrease .
RESULTS	None of the study participants had systemic adverse reactions during the study period .
CONCLUSIONS	SLIT in elderly patients with a grass pollen allergy generated a significant clinical improvement in the active group compared with the placebo group for grass pollen season .
CONCLUSIONS	This therapy was well tolerated .

###24635370
OBJECTIVE	Comparison of duration of surgery , blood loss , complications , lenght of post-operative hospitalisation and post-operative morbidity in a group of patient operated for the diagnosis FtM transsexualism .
METHODS	Retrospective clinical study .
METHODS	In our set of patients were 163 FtM transsexuals with caryotype 46 XX and normal gynecological finding ( 81 virgins ) .
METHODS	They were operated on from 1998-2012 at Department of Obstetrics and Gynecology The First Faculty of Medicine Charles University in Prague and Hospital Na Bulovce after at least of 12 months of hormonal preparation .
METHODS	We used following types of hysterectomy and bilateral adnexectomy : total abdominal hysterectomy from infraumbilical median laparotomy ( AHL ) or from suprapubic transverse incision - Pfannenstiel ( AH ) , laparoscopically assisted vaginal hysterectomy ( LAVH ) , total laparoscopic hysterectomy ( TLH ) .
METHODS	In two patients TLH and colpectomy was performed in one setting .
RESULTS	In the 23 AHL group the duration of the surgery was 54 minute , blood loss was 226 ml and the length of post-operative hospitalisation was 6.7 days .
RESULTS	In the 22 individualy of AH group the duration of the surgery was 60 minute , blood loss was 240 ml and the length of post-operative hospitalisation was 6.1 days .
RESULTS	In 4 patients of LAVH group the duration of the surgery was 73 minute , blood loss 200 ml and the length of post-operative hospitalisation was 5 days .
RESULTS	In the TLH group ( 112 pts ) the duration of the surgery was 91 minutes , blood loss was 121 ml and the length of post-operative hospitalisation was 4.4 days .
RESULTS	In the 2 TLH with colpectomy group the duration of the surgery was 152 minute , blood loss was 250 ml and the length of post-operative hospitalisation was 5.5 days .
RESULTS	In one case a peroperative lesion of urinary bladder occured and once a conversion TLH to AH for a strong vaginal bleeding was necessary .
RESULTS	Among postoperative complication in one case subileus in AH group was diagnosed , once vaginal bleeding , once haematoma in the suture and one case of secondary healing .
RESULTS	Postoperative complication after TLH included 4 times bleeding from vaginal suture , once haematoma in Douglas pouch , once seroma in the place of trocar insertion , once subileus .
RESULTS	Once ureter was injured and treated by the ureteral stent insertion .
RESULTS	Complication after AHL and LAVH were not recognised .
CONCLUSIONS	Total laparoscopic hysterectomy is the method of choice in the group of FtM transsexuals .
CONCLUSIONS	This technique could be used also in nuliparous women with long and narrow vagina .
CONCLUSIONS	Compared with laparotomic approach lower blood loss and shorter hospital stay was proved .
CONCLUSIONS	Earlier restitution of full activity is another advantage .
CONCLUSIONS	Musculus rectus abdominis flap can be used for phallus construction .
CONCLUSIONS	The only significant disadvantage is a longer duration of surgery .

###25236993
BACKGROUND	Nocturia is a chronic , fluctuating disease that disrupts sleep and has a wide-ranging impact on quality of life .
BACKGROUND	Valid tools to measure the patient-reported impact of nocturia are essential for evaluating the value of treatment , but the available tools are suboptimal .
OBJECTIVE	This study reports the development and validation of the Nocturia Impact Diary-an augmented form of the Nocturia Quality of Life questionnaire designed to be completed in conjunction with the widely used 3-day voiding diary .
METHODS	The process comprised three steps : Step 1 : Development of a concept pool using the Nocturia Quality of Life questionnaire and data from relevant studies ; Step 2 : Content validity study ; Step 3 : Psychometric testing of construct validity , reliability , and sensitivity of the diary in a randomized , placebo-controlled study in patients with nocturia .
RESULTS	Step 1 : Fourteen items and 4 domains were included in the first draft of the diary .
RESULTS	Step 2 : Twenty-three patients with nocturia participated in the cognitive debriefing study .
RESULTS	Items were adjusted accordingly , and the content validity was high .
RESULTS	Step 3 : Fifty-six patients were randomized to desmopressin orally disintegrating tablet or placebo .
RESULTS	The diary demonstrated high construct validity , with good sensitivity and a good fit to Rasch model , as well as high internal consistency , discriminatory ability , and acceptable sensitivity to change .
RESULTS	Results indicated that the diary was unidimensional .
CONCLUSIONS	The Nocturia Impact Diary is a convenient , validated patient-reported outcome measure .
CONCLUSIONS	It should be used in conjunction with a voiding diary to capture the real-life consequences of nocturia and its treatment .

###24280476
OBJECTIVE	To investigate the introduction of case tariff fee remuneration - as required by the current system - and its influence on patient satisfaction with the provision of physiotherapeutic treatment in an acute hospital aligned on a holistic , interdisciplinary therapeutic approach .
METHODS	Randomised controlled study with a total of 4598 patients were interviewed .
METHODS	No case tariff fee system was used during the years 2004 to 2006 .
METHODS	The data were compared with the results of interviews that took place during 2007 and 2008 ( use of DRGs ) .
METHODS	The results of this study are based on the largest survey performed to date of patient satisfaction with physiotherapeutic treatment in acute care focusing on a holistic interdisciplinary approach .
METHODS	In-patients being treated under DRG conditions were compared with a control group for whom the DRG system had not been applied .
METHODS	The target parameter of the study , which took more than five years , was the determination of patient satisfaction with the physiotherapeutic interventions .
RESULTS	There were no significant differences between the two groups in respect of satisfaction with the physiotherapeutic treatments received .
RESULTS	Regarding the outcome parameter encouragement to take more exercise , a significant change could be demonstrated under DRG conditions .
CONCLUSIONS	Physiotherapeutic interventions play an important role in the provision of interdisciplinary care .
CONCLUSIONS	In particular , the holistic perception of the patient , the interdisciplinary approach to complex diseases , and the requirements of the DRG system on the care provider can exert a positive influence on outcome quality .

###25420552
BACKGROUND	Performing regular exercise is known to manifest a number of health benefits that mainly relate to cardiovascular and muscular adaptations to allow for greater oxygen extraction and utilization .
BACKGROUND	There is increasing evidence that nutrient intake can affect the adaptive response to a single exercise bout , and that protein feeding is important to facilitate this process .
BACKGROUND	Thus , the exercise-nutrient interaction may potentially lead to a greater response to training .
BACKGROUND	The role of post-exercise protein ingestion in enhancing the effects of running-based endurance exercise training relative to energy-matched carbohydrate intervention remains to be established .
BACKGROUND	Additionally , the influence of immediate versus overnight protein ingestion in mediating these training effects is currently unknown .
BACKGROUND	The current protocol aims to establish whether post-exercise nutrient intake and timing would influence the magnitude of improvements during a prescribed endurance training program .
METHODS	The project involves two phases with each involving two treatment arms applied in a randomized investigator-participant double-blind parallel group design .
METHODS	For each treatment , participants will be required to undergo six weeks of running-based endurance training .
METHODS	Immediately post-exercise , participants will be prescribed solutions providing 0.4 grams per kilogram of body mass ( g kg ( -1 ) ) of whey protein hydrolysate plus 0.4 g kg ( -1 ) sucrose , relative to an isocaloric sucrose control ( 0.8 g kg ( -1 ) ; Phase I ) .
METHODS	In Phase II , identical protein supplements will be provided ( 0.4 + 0.4 g kg ( -1 ) h ( -1 ) of whey protein hydrolysate and sucrose , respectively ) , with the timing of ingestion manipulated to compare immediate versus overnight recovery feedings .
METHODS	Anthropometric , expired gas , venous blood and muscle biopsy samples will be obtained at baseline and following the six-week training period .
CONCLUSIONS	By investigating the role of nutrition in enhancing the effects of endurance exercise training , we will provide novel insight regarding nutrient-exercise interactions and the potential to help and develop effective methods to maximize health or performance outcomes in response to regular exercise .
BACKGROUND	Current Controlled Trials registration number : ISRCTN27312291 ( date assigned : 4 December 2013 ) .
BACKGROUND	The first participant was randomized on 11 December 2013 .

###25068290
OBJECTIVE	We aimed to assess changes in myositis core set measures and ancillary clinical and laboratory data from the National Institutes of Health 's subset of patients enrolled in the Rituximab in Myositis trial .
METHODS	Eighteen patients ( 5 dermatomyositis , 8 polymyositis , 5 juvenile dermatomyositis ) completed more in-depth testing of muscle strength and cutaneous assessments , patient-reported outcomes , and laboratory tests before and after administration of rituximab .
METHODS	Percentage change in individual measures and in the definitions of improvement ( DOIs ) and standardized response means were examined over 44 weeks .
RESULTS	Core set activity measures improved by 18-70 % from weeks 0-44 and were sensitive to change .
RESULTS	Fifteen patients met the DOI at week 44 , 9 patients met a DOI 50 % response , and 4 met a DOI 70 % response .
RESULTS	Muscle strength and function measures were more sensitive to change than cutaneous assessments .
RESULTS	Constitutional , gastrointestinal , and pulmonary systems improved 44-70 % .
RESULTS	Patient-reported outcomes improved up to 28 % .
RESULTS	CD20 + B cells were depleted in the periphery , but B cell depletion was not associated with clinical improvement at week 16 .
CONCLUSIONS	This subset of patients had high rates of clinical response to rituximab , similar to patients in the overall trial .
CONCLUSIONS	Most measures were responsive , and muscle strength had a greater degree of change than cutaneous assessments .
CONCLUSIONS	Several novel assessment tools , including measures of strength and function , extra-muscular organ activity , fatigue , and health-related quality of life , are promising for use in future myositis trials .
CONCLUSIONS	Further study of B cell-depleting therapies in myositis , particularly in treatment-nave patients , is warranted .

###24484540
BACKGROUND	Rapid diagnostic tests ( RDTs ) for malaria provide a practical alternative to light microscopy for malaria diagnosis in resource-limited settings .
BACKGROUND	Three-band RDTs incorporating two parasite antigens may have enhanced diagnostic specificity , relative to two-band RDTs with a single parasite antigen ( typically histidine-rich protein 2 [ HRP2 ] ) .
METHODS	Phase 1 : 2,000 children , two months to five years of age , admitted to a referral hospital in Jinja , Uganda , with acute febrile illness were enrolled .
METHODS	A WHO highly rated three-band RDT was compared to light microscopy of thick peripheral blood films read by local expert microscopists.Phase 2 : the three-band RDT was used as a screening tool for inclusion of patients in a clinical trial , and subjects with three positive RDT bands were tested by microscopy using blood samples drawn in parallel .
METHODS	Discordant results were adjudicated by PCR .
RESULTS	Phase 1 : 1,648 children had both a RDT and peripheral blood smear performed .
RESULTS	The specificity of a RDT with all three bands positive was 82 % ( 95 % CI : 79-85 % ) compared to 62 % ( 95 % CI : 59-66 % ) for HRP2 alone .
RESULTS	The sensitivity was 88 % ( 95 % CI : 85-89 % ) and 94 % ( 95 % CI : 92-95 % ) for three-band positive RDT and HRP2 antigen , respectively .
RESULTS	119 patients ( 7.2 % ) had a positive HRP2 band , but negative parasite lactate dehydrogenase ( pLHD ) band and negative peripheral smear , and 72 ( 61 % ) of these had received pre-treatment with anti-malarials , suggesting a false positive HRP2 result ( p = 0.002 ) .
RESULTS	Phase 2 : the positive predictive value ( PPV ) of the three-band RDT was 94 % ( 95 % CI 89 % -97 % ) using microscopy as the reference standard .
RESULTS	However , microscopy-discordant results were shown to be positive for P. falciparum by PCR in all cases , suggesting that the PPV was in fact higher .
CONCLUSIONS	The pLDH antigen on three-band RDTs , used in combination with HRP2 , provides added diagnostic specificity for malaria parasitaemia and may be useful to distinguish acute infection from recently treated infection .
CONCLUSIONS	In situations where diagnostic specificity is desirable ( e.g. , for selection of malaria-infected participants in clinical trials ) , a three-band RDT should be considered in a sub-Saharan African setting .

###24657333
BACKGROUND	Hydrochlorothiazide , an effective antihypertensive medication commonly prescribed to blacks , decreases urinary calcium excretion .
BACKGROUND	Blacks have significantly higher rates of hypertension and lower levels of 25-hydroxyvitamin D. Thus , they are more likely to be exposed to vitamin D supplementation and thiazide diuretics .
BACKGROUND	The risk for hypercalcemia among blacks using vitamin D and hydrochlorothiazide is undefined .
METHODS	We assessed the frequency of hypercalcemia in hydrochlorothiazide users in a post hoc analysis of a randomized , double-blind , dose-finding trial of 328 blacks ( median age 51 years ) assigned to either placebo , or 1000 , 2000 , or 4000 international units of cholecalciferol ( vitamin D3 ) daily for 3 months during the winter ( 2007-2010 ) .
RESULTS	Of the 328 participants , 84 reported hydrochlorothiazide use and had serum calcium levels assessed .
RESULTS	Additionally , a comparison convenience group of 44 enrolled participants who were not taking hydrochlorothiazide had serum calcium measurements at 3 months , but not at baseline .
RESULTS	At 3 months , hydrochlorothiazide participants had higher calcium levels ( 0.2 mg/dL , P < .001 ) than nonhydrochlorothiazide participants , but only one participant in the hydrochlorothiazide group had hypercalcemia .
RESULTS	In contrast , none of the nonhydrochlorothiazide participants had hypercalcemia .
RESULTS	In a linear regression model adjusted for age , sex , 25-hydroxyvitamin D at 3 months , and other covariates , only hydrochlorothiazide use ( Estimate [ SE ] : 0.05 [ 0.01 ] , P = .01 ) predicted serum calcium at 3 months .
CONCLUSIONS	In summary , vitamin D3 supplementation up to 4000 IU in hydrochlorothiazide users is associated with an increase in serum calcium but a low frequency of hypercalcemia .
CONCLUSIONS	These findings suggest that participants of this population can use hydrochlorothiazide with up to 4000 IU of vitamin D3 daily and experience a low frequency of hypercalcemia .

###24862906
BACKGROUND	This study determined whether the presence of nonsustained ventricular tachycardia ( NSVT ) was predictive of clinical events in MADIT-CRT ( multicenter automatic defibrillator implantation trial-cardiac resynchronization therapy ) patients treated with CRT-defibrillator .
RESULTS	We analyzed 24-hour Holters for the presence of NSVT .
RESULTS	Patients were then stratified by the etiology ( ischemic or nonischemic ) of cardiomyopathy .
RESULTS	The impact of NSVT on heart failure events ( HF ) , implantable cardioverter-defibrillator ( ICD ) therapy for rapid ventricular tachycardia ( VT ) or fibrillation ( VF ) , and reverse remodeling was determined .
RESULTS	At least a single episode of NSVT was recorded in 483 ( 49 % ) patients .
RESULTS	These patients had a higher burden of premature ventricular contractions , lower percentage of biventricular ( BiV ) pacing , and significantly less reduction in left ventricular end-diastolic and end-systolic volumes .
RESULTS	The risk of HF was significantly greater in patients with nonischemic cardiomyopathy and NSVT ( hazard ratio [ HR ] 2.89 ; 95 % confidence interval [ CI ] : 1.49-5 .61 ; P = 0.002 ) .
RESULTS	The risk of rapid VT/VF was significantly greater ( in both ischemic and nonischemic patients ) when NSVT was observed ( HR 2.06 ; 95 % CI : 1.30-3 .26 ; P = 0.002 in ischemic patients ; HR 3.09 ; 95 % CI : 1.80-5 .28 ; P < 0.001 in nonischemic patients ) .
CONCLUSIONS	MADIT-CRT patients with NSVT had a high burden of ventricular ectopy , lower percentage of BiV pacing , and less reverse remodeling .
CONCLUSIONS	These patients had an increase in HF ( in nonischemic cardiomyopathy patients ) and rapid VT/VF ICD therapies ( in ischemic and nonischemic patients ) .
CONCLUSIONS	These findings may have implications for the management of nonsustained ventricular ectopy in CRT patients .

###25171883
OBJECTIVE	Postoperative esophageal strictures frequently recur .
OBJECTIVE	We assessed the efficacy of injecting triamcinolone after bougie dilation in comparison to dilation alone .
METHODS	In a double-blind randomized fashion , 19 patients ( 68 % male with mean age of 53-years old ) with non-dilated esophagogastric complex strictures after esophagectomy with gastric pull-up were assigned to receive dilation alone ( control ) or 40 mg of triamcinolone at the borders of the wall lacerations caused by the bougienage in each dilation session during the study follow-up .
METHODS	Dysphagia and complications were assessed at 1 , 2 , and 6 months .
METHODS	Primary end-point was to be dysphagia-free .
RESULTS	After 1 month of the beginning of therapy , 4 patients in the steroid group were without dysphagia , in comparison to 0 patient in the control group ( P = 0.021 ) .
RESULTS	Six months after endoscopic therapy , 62 % of the cases in the triamcinolone group versus none in the control group were dysphagia-free ( P = 0.009 ) .
RESULTS	There was no perforation nor hemorrhage .
CONCLUSIONS	Injecting triamcinolone after every dilation session next to or at the borders of the lacerations caused by the dilators , results in a significant improvement or resolution of dysphagia .

###24566599
OBJECTIVE	Few publications of prospective studies have described patient outcomes in community-acquired bacterial pneumonia ( CABP ) - associated bacteremia .
OBJECTIVE	Our objective , in performing this subgroup analysis , was to assess outcomes in subjects with CABP-associated bacteremia in 2 randomized , double-blind clinical studies comparing treatment with ceftaroline fosamil versus ceftriaxone .
METHODS	Our analysis summarizes baseline subject demographics , distribution of baseline pathogens isolated from blood cultures , clinical response rates at Day 4 , and clinical cure rates at end of therapy and test of cure ( 8 to 15 days after end of therapy ) in subjects with bacteremic CABP in the ceFtarOline Community-acquired pneUmonia trial vS ceftriaxone in hospitalized patients ( FOCUS ) studies .
RESULTS	In the FOCUS studies , 23 of 614 patients in the ceftaroline fosamil-treated group and 22 of 614 patients in the ceftriaxone-treated group had CABP-associated bacteremia .
RESULTS	Baseline demographics were similar between groups .
RESULTS	Streptococcus pneumoniae was the most common baseline bloodstream isolate .
RESULTS	For subjects with CABP-associated bacteremia , clinical response/cure rates were similar at Day 4 ( 60.9 % vs 59.1 % ) , end of therapy ( 69.6 % vs 72.7 % ) , and test of cure ( 69.6 % vs 68.2 % ) for ceftaroline fosamil and ceftriaxone , respectively .
CONCLUSIONS	In subjects with CABP-associated bacteremia , ceftaroline fosamil demonstrated similar clinical outcomes at Day 4 , end of therapy , and test of cure compared with ceftriaxone .

###24560554
OBJECTIVE	To evaluate changes in anterior corneal topography after femtosecond laser-created clear corneal incisions ( CCIs ) .
METHODS	Fondazione G.B. Bietti IRCCS , Rome , Italy .
METHODS	Comparative case series .
METHODS	Phacoemulsification was performed through a 2.75 mm incision .
METHODS	In the study group , a 3-plane CCI was created using a 150 kHz femtosecond laser .
METHODS	In the control group , a single-plane angled CCI was created using disposable knives .
METHODS	Placido disk corneal topography was performed preoperatively and 1 week and 1 month postoperatively .
METHODS	Central curvature ( simulated keratometry [ K ] ) and local changes in anterior corneal topography at the CCI site were evaluated and compared between groups .
RESULTS	No significant changes in the mean simulated K values were found in either group postoperatively ( P > .05 ) .
RESULTS	The preoperative to 1-month postoperative mean simulated K ranged between 43.30 diopters ( D ) 0.82 ( SD ) and 43.170.82 D in the study group and between 43.341.44 D and 43.291.48 D in the control group .
RESULTS	The method of CCI creation significantly influenced the changes in the anterior central topography during the first month postoperatively ( P < .001 ) .
RESULTS	Greater steepening of the incision edges was found in the control group ( mean 36.604.13 D to 37.742.39 D ) than in the study group ( mean 38.812.91 D to 39.154.48 D ) .
CONCLUSIONS	The 2.75 mm 3-plane femtosecond CCIs induced slight changes in the anterior central corneal topography , similar to single-plane angled manual incisions .
CONCLUSIONS	Topographic differences between the femtosecond method and manual method were found at the CCI site .
BACKGROUND	No author has a financial or proprietary interest in any material or method mentioned .

###24733235
BACKGROUND	Heavy-drinking smokers constitute a sizeable and hard-to-treat subgroup of smokers , for whom tailored smoking cessation therapies are not yet available .
OBJECTIVE	The present study used a double-blind , randomized , 22 medication design , testing varenicline alone ( VAR ; 1 mg twice daily ) , low dose naltrexone alone ( L-NTX ; 25 mg once daily ) , varenicline plus naltrexone , and placebo for effects on cigarette craving and subjective response to alcohol and cigarettes in a sample ( n = 130 ) of heavy-drinking daily smokers ( 10 cigarettes/day ) .
METHODS	All participants were tested after a 9-day titration period designed to reach a steady state on the target medication .
METHODS	Testing was completed at 12 h of nicotine abstinence , after consuming a standard dose of alcohol ( target breath alcohol concentration = 0.06 g/dl ) and after smoking the first cigarette of the day .
RESULTS	The combination of VAR+L - NTX was superior to placebo , and at times superior to monotherapy , in attenuating cigarette craving , cigarette and alcohol `` high , '' and in reducing ad-lib consumption of both cigarettes and alcohol during the 9-day medication titration period .
CONCLUSIONS	These preliminary findings indicate that clinical studies of the combination of VAR+L - NTX for heavy drinkers trying to quit smoking are warranted and may ultimately improve clinical care for this sizeable and treatment-resistant subgroup of smokers .

###25355977
OBJECTIVE	The Rapid Emergency Alert Communication in Health ( REACH ) Trial was a randomized control trial to systematically compare and evaluate the effectiveness of traditional and mobile communication modalities for public health agencies to disseminate time-sensitive information to health-care providers ( HCPs ) .
OBJECTIVE	We conducted a sub-study to identify the communication channels by which HCPs preferred receiving public health alerts and advisories .
METHODS	Enrolled HCPs were blindly randomized into four message delivery groups to receive time-sensitive public health messages by e-mail , fax , or short message service ( SMS ) or to a no-message control group .
METHODS	Follow-up interviews were conducted 5-10 days after the message .
METHODS	In the final interview , additional questions were asked regarding HCP preferences for receiving public health alerts and advisories .
METHODS	We examined the relationship between key covariates and preferred method of receiving public health alert and advisory messages .
RESULTS	Gender , age , provider type , and study site showed statistically significant associations with delivery method preference .
RESULTS	Older providers were more likely than younger providers to prefer e-mail or fax , while younger providers were more likely than older providers to prefer receiving messages via SMS .
CONCLUSIONS	There is currently no evidence-based research to guide or improve communication between public health agencies and HCPs .
CONCLUSIONS	Understanding the preferences of providers for receiving alerts and advisories may improve the effectiveness of vital public health communications systems and , in turn , may enhance disease surveillance , aid in early detection , and improve case finding and situational awareness for public health emergencies .

###24631162
BACKGROUND	In head-to-head comparisons of coronary drug-eluting stents , the primary endpoint is traditionally assessed after 9-12 months .
BACKGROUND	However , the optimum timepoint for this assessment remains unclear .
BACKGROUND	In this study , we assessed clinical outcomes at up to 5 years ' follow-up in patients who received two different types of drug-eluting stents .
METHODS	We undertook this multicentre , open-label , randomised superiority trial at five percutaneous coronary intervention centres in Denmark .
METHODS	We randomly allocated 2332 eligible adult patients ( 18 years of age ) with an indication for drug-eluting stent implantation to the zotarolimus-eluting Endeavor Sprint stent ( Medtronic , Santa Rosa , CA , USA ) or the sirolimus-eluting Cypher Select Plus stent ( Cordis , Johnson & Johnson , Warren , NJ , USA ) .
METHODS	Randomisation of participants was achieved by computer-generated block randomisation and a telephone allocation service .
METHODS	The primary endpoint of the SORT OUT III study was a composite of major adverse cardiac events-cardiac death , myocardial infarction , and target vessel revascularisation-at 9 months ' follow-up .
METHODS	In this study , endpoints included the occurrence of major adverse cardiac events and definite stent thrombosis at follow-up times of up to 5 years .
METHODS	Analysis was by intention to treat .
METHODS	The trial is registered with ClinicalTrials.gov , number NCT00660478 .
RESULTS	We randomly allocated 1162 patients to receive the zotarolimus-eluting stent and 1170 to the sirolimus-eluting stent .
RESULTS	At 5-year follow-up , rates of major adverse cardiac events were similar in patients treated with both types of stents ( zotarolimus-eluting stents 197/1162 [ 17.0 % ] vs sirolimus-eluting stents 182/1170 [ 15.6 % ] ; odds ratio [ OR ] 1.10 , 95 % CI 0.88-1 .37 ; p = 0.40 ) .
RESULTS	This finding was indicative of the directly contrasting results for rates of major adverse cardiac events at 1-year follow up ( zotarolimus 93/1162 [ 8.0 % ] vs sirolimus 46/1170 [ 3.9 % ] ; OR 2.13 , 95 % CI 1.48-3 .07 ; p < 0.0001 ) compared with those at follow-up between 1 and 5 years ( 104 [ 9.0 % ] vs 136 [ 11.6 % ] ; OR 0.78 , 95 % CI 0.59-1 .02 ; p = 0.071 ) .
RESULTS	At 1-year follow-up , definite stent thrombosis was more frequent after implantation of the zotarolimus-eluting stent ( 13/1162 [ 1.1 % ] ) than the sirolimus-eluting stent ( 4/1170 [ 0.3 % ] ; OR 3.34 , 95 % CI 1.08-10 .3 ; p = 0.036 ) , whereas the opposite finding was recorded for between 1 and 5 years ' follow-up ( zotarolimus-eluting stent 1/1162 [ 0.1 % ] vs sirolimus-eluting stent 21/1170 [ 1.8 % ] , OR 0.05 , 95 % CI 0.01-0 .36 ; p = 0.003 ) .
RESULTS	26 of 88 ( 30 % ) target lesion revascularisations in the zotarolimus-eluting stent group occurred between 1 and 5 years ' follow-up , whereas 54 of 70 ( 77 % ) of those in the sirolimus-eluting stent group occurred during this follow-up period .
CONCLUSIONS	The superiority of sirolimus-eluting stents compared with zotarolimus-eluting stents at 1-year follow-up was lost after 5 years .
CONCLUSIONS	The traditional 1-year primary endpoint assessment therefore might be insufficient to predict 5-year clinical outcomes in patients treated with coronary drug-eluting stent implantation .
BACKGROUND	Cordis and Medtronic .

###24650076
BACKGROUND	Numerous studies indicate that the use of feeding tubes ( FT ) in persons with advanced cognitive impairment ( CI ) does not improve clinical outcomes or survival , and results in higher rates of hospitalization and emergency department ( ED ) visits .
BACKGROUND	It is not clear , however , whether such risk varies by resident level of CI and whether these ED visits and hospitalizations are potentially preventable .
BACKGROUND	The objective of this study was to determine the rates of ED visits , hospitalizations and potentially preventable ambulatory care sensitive ( ACS ) ED visits and ACS hospitalizations for long-stay NH residents with FTs at differing levels of CI .
METHODS	We linked Centers for Medicare and Medicaid Services inpatient & outpatient administrative claims and beneficiary eligibility data with Minimum Data Set ( MDS ) resident assessment data for nursing home residents with feeding tubes in a 5 % random sample of Medicare beneficiaries residing in US nursing facilities in 2006 ( n = 3479 ) .
METHODS	Severity of CI was measured using the Cognitive Performance Scale ( CPS ) and categorized into 4 groups : None/Mild ( CPS = 0-1 , MMSE = 22-25 ) , Moderate ( CPS = 2-3 , MMSE = 15-19 ) , Severe ( CPS = 4-5 , MMSE = 5-7 ) and Very Severe ( CPS = 6 , MMSE = 0-4 ) .
METHODS	ED visits , hospitalizations , ACS ED visits and ACS hospitalizations were ascertained from inpatient and outpatient administrative claims .
METHODS	We estimated the risk ratio of each outcome by CI level using over-dispersed Poisson models accounting for potential confounding factors .
RESULTS	Twenty-nine percent of our cohort was considered `` comatose '' and `` without any discernible consciousness '' , suggesting that over 20,000 NH residents in the US with feeding tubes are non-interactive .
RESULTS	Approximately 25 % of NH residents with FTs required an ED visit or hospitalization , with 44 % of hospitalizations and 24 % of ED visits being potentially preventable or for an ACS condition .
RESULTS	Severity of CI had a significant effect on rates of ACS ED visits , but little effect on ACS hospitalizations .
CONCLUSIONS	ED visits and hospitalizations are common in cognitively impaired tube-fed nursing home residents and a substantial proportion of ED visits and hospitalizations are potentially preventable due to ACS conditions .

###25996101
OBJECTIVE	This study was conducted to investigate the efficacy and safety of using a concurrent neoadjuvant chemoradiotherapy ( a XELOX regimen ) to treat adenocarcinoma of the gastroesophageal junction .
METHODS	Seventy-six patients having resectable adenocarcinoma at the gastroesophageal junction ( T3/4 , N + , M0 ) were recruited to participate and randomly assigned to either a chemoradiotherapy group or a surgery group .
METHODS	Patients in the chemoradiotherapy group were orally given capecitabine ( 1,000 mg/m2 , twice daily for 14 days , days 1-14 ) and intravenous oxaliplatin ( 130 mg/m2 on day 1 ) for 2 cycles .
METHODS	Radiotherapy was performed with a total of 45 Gy administered in 25 sessions for 5 weeks .
METHODS	Patients in the surgery group received only surgical intervention .
RESULTS	In the concurrent chemoradiotherapy group , the overall response rate was 55.6 % ( 20/36 ) , tumor control rate was 100 % and a pathological complete response was achieved in 16.7 % ( 6/36 ) .
RESULTS	The entire chemoradiotherapy group had R0 resections as did 80 % of the surgery group ( 32/40 ) ( P < 0.05 ) .
RESULTS	In the concurrent chemoradiotherapy group , 6 patients developed grade 3 side effects .
RESULTS	Treatment was either discontinued or the dose adjusted .
RESULTS	Major hematological side effects in the chemoradiotherapy group included leukopenia , neutropenia , anemia and thrombocytopenia .
RESULTS	Nonhematological side effects included nausea , vomiting and appetite loss .
RESULTS	Chemoradiotherapy-related death was not observed .
CONCLUSIONS	Concurrent neoadjuvant chemoradiotherapy administration increased the rate of R0 resection and demonstrated favorable safety in patients with Siewert II or III adenocarcinoma at the gastroesophageal junction .
CONCLUSIONS	These results support the use of neoadjunctive chemoradiotherapy in the treatment of adenocarcinoma of the gastroesophageal junction .

###24563178
OBJECTIVE	In the 2010 American Heart Association guidelines , supraglottic devices ( SGDs ) such as the laryngeal mask are proposed as alternatives to tracheal intubation for cardiopulmonary resuscitation .
OBJECTIVE	Some SGDs can also serve as a means for tracheal intubation after successful ventilation .
OBJECTIVE	The purpose of this study was to evaluate the effect of chest compression on airway management with four intubating SGDs , aura-i ( aura-i ) , air-Q ( air-Q ) , i-gel ( i-gel ) , and Fastrack ( Fastrack ) , during cardiopulmonary resuscitation using a manikin .
METHODS	Twenty novice physicians inserted the four intubating SGDs into a manikin with or without chest compression .
METHODS	Insertion time and successful ventilation rate were measured .
METHODS	For cases of successful ventilation , blind tracheal intubation via the intubating SGD was performed with chest compression and success or failure within 30 s was recorded .
RESULTS	Chest compression did not decrease the ventilation success rate of the four intubating SGDs ( without chest compression ( success/total ) : air-Q , 19/20 ; aura-i , 19/20 ; i-gel , 18/20 ; Fastrack , 19/20 ; with chest compression : air-Q , 19/20 ; aura-i , 19/20 ; i-gel , 16/20 ; Fastrack , 18/20 ) .
RESULTS	Insertion time was significantly lengthened by chest compression in the i-gel trial ( P < 0.05 ) , but not with the other three devices .
RESULTS	The blind intubation success rate with chest compression was the highest in the air-Q trial ( air-Q , 15/19 ; aura-i , 14/19 ; i-gel , 12/16 ; Fastrack , 10/18 ) .
CONCLUSIONS	This simulation study revealed the utility of intubating SGDs for airway management during chest compression .

###25424464
OBJECTIVE	To assess the effectiveness of a two-year school-based intervention , consisting of integrated and replicable physical activity and nutritional education on weight , fat percentage , cardiovascular risk factors , and blood pressure .
METHODS	Six elementary schools in Reykjavik were randomly assigned to be either intervention ( n = 3 ) or control ( n = 3 ) schools .
METHODS	Seven-year-old children in the second grade in these schools were invited to participate ( n = 321 ) ; 268 ( 83 % ) underwent some or all of the measurements .
METHODS	These 286 children were followed up for two years .
METHODS	Children in intervention schools participated in an integrated and replicable physical activity programme , increasing to approximately 60 minutes of physical activity during school in the second year of intervention .
METHODS	Furthermore , they received special information about nutrition , and parents , teachers , and school food service staff were all involved in the intervention .
METHODS	Subjects .
METHODS	321seven-year-old schoolchildren .
METHODS	Blood pressure , obesity , percentage of body fat , lipid profile , fasting insulin .
RESULTS	Children in the intervention group had a 2.3 mmHg increase in systolic blood pressure ( SBP ) and a 2.9 mmHg increase in diastolic blood pressure ( DBP ) over the two-year intervention period , while children in the control group increased SBP by 6.7 mmHg and DPB by 8.4 mmHg .
RESULTS	These changes were not statistically significant .
RESULTS	Furthermore there were no significant changes in percentage body fat , lipid profile , or fasting insulin between the intervention and control schools .
CONCLUSIONS	A two-year school-based intervention with increased physical activity and healthy diet did not have a significant effect on common cardiovascular risk factors .

###24485549
BACKGROUND	Recent conflicts have been characterised by the use of improvised explosive devices causing devastating injuries , including heavily contaminated wounds requiring meticulous surgical debridement .
BACKGROUND	After being rendered surgical clean , these wounds are dressed and the patient transferred back to the UK for on-going treatment .
BACKGROUND	A dressing that would prevent wounds from becoming colonised during transit would be desirable .
BACKGROUND	The aim of this study was to establish whether using nanocrystalline silver dressings , as an adjunct to the initial debridement , would positively affect wound microbiology and wound healing compared to standard plain gauze dressings .
METHODS	Patients were prospectively randomised to receive either silver dressings , in a nanocrystalline preparation ( Acticoat ) , or standard of care dressings ( plain gauze ) following their initial debridement in the field hospital .
METHODS	On repatriation to the UK microbiological swabs were taken from the dressing and the wound , and an odour score recorded .
METHODS	Wounds were followed prospectively and time to wound healing was recorded .
METHODS	Additionally , patient demographic data were recorded , as well as the mechanism of injury and Injury Severity Score .
RESULTS	76 patients were recruited to the trial between February 2010 and February 2012.39 received current dressings and 37 received the trial dressings .
RESULTS	Eleven patients were not swabbed .
RESULTS	There was no difference ( p = 0.1384 , Fishers ) in the primary outcome measure of wound colonisation between the treatment arm ( 14/33 ) and the control arm ( 20/32 ) .
RESULTS	Similarly time to wound healing was not statistically different ( p = 0.5009 , Mann-Whitney ) .
RESULTS	Wounds in the control group were scored as being significantly more malodorous ( p = 0.002 , Mann-Whitney ) than those in the treatment arm .
CONCLUSIONS	This is the first randomised controlled trial to report results from an active theatre of war .
CONCLUSIONS	Performing research under these conditions poses additional challenges to military clinicians .
CONCLUSIONS	Meticulous debridement of wounds remains the critical determinant in wound healing and infection and this study did not demonstrate a benefit of nanocrystaline silver dressing in respect to preventing wound colonisation or promoting healing , these dressings do however seem to significantly reduce the unpleasant odour commonly associated with battlefield wounds .

###25494217
BACKGROUND	The acute respiratory distress syndrome ( ARDS ) is a common devastating syndrome in intensive care unit in critically ill patients .
BACKGROUND	Continuous renal replacement therapy ( CRRT ) has been shown beneficial effects on oxygenation and survival in patients with ARDS .
BACKGROUND	However , it is still controversial about the timing of initiation of CRRT .
METHODS	Fifty-three patients with ARDS admitted to intensive care unit in Zhejiang Provincial People 's Hospital , China from 2009 to 2013 were enrolled in the study .
METHODS	The authors compared ventilation parameter , including PaO2/FIO2 , A-a gradient , positive end-expiratory pressure , plateau pressure , dynamic compliance and hemodynamic parameters , including central venous pressure , mean arterial pressure , cardiac index , extravascular lung water index , fluid balance between early initiation ( within 12 hours after ARDS onset ) and late initiation of CRRT ( 48 hours after ARDS onset ) groups .
METHODS	The authors further investigated transforming growth factor ( TGF ) -1 level changes in serum and bronchoalveolar lavage fluid ( BALF ) by enzyme-linked immunosorbent assay during 7 days of follow-up .
RESULTS	Significant improvement of oxygenation and shorter duration of mechanical ventilation were observed in early CRRT group during 7-day follow-up .
RESULTS	In addition , TGF-1 concentrations in serum and BALF were significantly decreased in patients with early initiation of CRRT compared to those with late initiation of CRRT on day 2 and day 7 .
RESULTS	Furthermore , patients who died of ARDS had higher levels of TGF-1 in BALF than survivors .
CONCLUSIONS	Our findings showed that early initiation of CRRT is associated with favorable clinical outcomes in ARDS patients , which might be due to the reduced serum and BALF TGF-1 levels through CRRT .
CONCLUSIONS	However , large multi-center studies are needed to make further recommendations as to the optimal use of CRRT in ARDS patient populations .

###25925801
BACKGROUND	The use of amphetamine-type stimulants ( ATS ) places a large burden on health services .
OBJECTIVE	The aim was to evaluate the effectiveness of a self-guided Web-based intervention ( `` breakingtheice '' ) for ATS users over 6 months via a free-to-access site .
METHODS	We conducted a randomized trial comparing a waitlist control with a fully automated intervention containing 3 modules derived from cognitive behavioral therapy and motivation enhancement .
METHODS	The main outcome was self-reported ATS use in the past 3 months assessed at 3 - and 6-month follow-ups using the Alcohol , Smoking , and Substance Involvement Screening Test ( ASSIST ) .
METHODS	Secondary outcomes were help-seeking intentions ( general help-seeking questionnaire ) , actual help seeking ( actual help-seeking questionnaire ) , psychological distress ( Kessler 10 ) , polydrug use ( ASSIST ) , quality of life ( European Health Interview Survey ) , days out of role , and readiness to change .
METHODS	Follow-up data were evaluated using an intention-to-treat ( ITT ) analysis with a group by time interaction .
RESULTS	We randomized 160 people ( intervention : n = 81 ; control : n = 79 ) .
RESULTS	At 6 months , 38 of 81 ( 47 % ) intervention and 41 of 79 ( 52 % ) control participants provided data .
RESULTS	ATS scores significantly declined for both groups , but the interaction effect was not significant .
RESULTS	There were significant ITT time by group interactions for actual help seeking ( rate ratio [ RR ] 2.16 ; d = 0.45 ) and help-seeking intentions ( RR 1.17 ; d = 0.32 ) , with help seeking increasing for the intervention group and declining for the control group .
RESULTS	There were also significant interactions for days completely ( RR 0.50 ) and partially ( RR 0.74 ) out of role favoring the intervention group .
RESULTS	However , 37 % ( 30/81 ) of the intervention group did not complete even 1 module .
CONCLUSIONS	This self-guided Web-based intervention encouraged help seeking associated with ATS use and reduced days out of role , but it did not reduce ATS use .
CONCLUSIONS	Thus , this program provides a means of engaging with some sections of a difficult-to-reach group to encourage treatment , but a substantial minority remained disengaged .
BACKGROUND	Australian and New Zealand Clinical Trials Registry : ACTRN12611000947909 ; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=343307 ( Archived by WebCite at http://www.webcitation.org/6Y0PGGp8q ) .

###25775747
OBJECTIVE	To investigate the treatment of benign positional paroxysmal vertigo of posterior semi-circular canal by Epley maneuver combined with Semont maneuver .
METHODS	One hundred and fifty patients with benign positional paroxysmal vertigo of posterior semicircular canal were randomly divided into three groups : group A , B and C. Patients in group A were treated by Epley maneuver and patients in group B were treated by Semont maneuver .
METHODS	Patients in group C were received the treatment of Epley maneuver combined with Semont ma - neuver .
METHODS	We recorded the times of treatments in different groups respectively .
METHODS	Statistics of treatment effects and follow-up studies with 3 months after the recovery were assessed .
RESULTS	The cure rate of the canalith repositioning on the primary , secondary and tertiary treatment in group A was respective 72 % ( 38/53 ) and 81 % ( 43/53 ) and 85 % ( 45/53 ) , in group B was 68 % ( 30/44 ) and 80 % ( 35/44 ) and 84 % ( 37/44 ) , in group C was 89 % ( 47/53 ) and 94 % ( 50/53 ) and 98 % ( 52/53 ) .
RESULTS	The cure rate in group C is significantly higher than group A and group B ( 2 = 6.777 , P < 0.05 ; 2 = 6.647 , P < 0.05 ) .
RESULTS	3 months after recovery 6 patients in group A , 5 patients in group B and 1 patient in group C were relapsed .
CONCLUSIONS	By the use of Epley maneuver combined with Semont maneuver in the treatment of benign positional paroxysmal vertigo of posterior semicircular canal , the primary cure rate was increased and the numbers of treatments were reduced and the relapse was decreased .
CONCLUSIONS	It is suitable to use Epley maneuver combined with Semont maneuver in the clinic .

###24887970
OBJECTIVE	To examine the feasibility and outcomes of video-based peer feedback through social networking to facilitate robotic surgical skill acquisition .
BACKGROUND	The acquisition of surgical skills may be challenging for novel techniques and/or those with prolonged learning curves .
METHODS	Randomized controlled trial involving 41 resident physicians performing the Tubes ( Da Vinci Intuitive Surgical , Sunnyvale , CA ) simulator exercise with versus without peer feedback of video-recorded performance through a social networking Web page .
METHODS	Data collected included simulator exercise score , time to completion , and comfort and satisfaction with robotic surgery simulation .
RESULTS	There were no baseline differences between the intervention group ( n = 20 ) and controls ( n = 21 ) .
RESULTS	The intervention group showed improvement in mean scores from session 1 to sessions 2 and 3 ( 60.7 vs 75.5 , P < 0.001 , and 60.7 vs 80.1 , P < 0.001 , respectively ) .
RESULTS	The intervention group scored significantly higher than controls at sessions 2 and 3 ( 75.5 vs 59.6 , P = 0.009 , and 80.1 vs 65.9 , P = 0.019 , respectively ) .
RESULTS	The mean time ( seconds ) to complete the task was shorter for the intervention group than for controls during sessions 2 and 3 ( 217.4 vs 279.0 , P = 0.004 , and 201.4 vs 261.9 , P = 0.006 , respectively ) .
RESULTS	At the study conclusion , feedback subjects were more comfortable with robotic surgery than controls ( 90 % vs 62 % , P = 0.021 ) and expressed greater satisfaction with the learning experience ( 100 % vs 67 % , P = 0.014 ) .
RESULTS	Of the intervention subjects , 85 % found that peer feedback was useful and 100 % found it effective .
CONCLUSIONS	Video-based peer feedback through social networking appears to be an effective paradigm for surgical education and accelerates the robotic surgery learning curve during simulation .

###25218906
BACKGROUND	Olaparib is a poly ( ADP-ribose ) polymerase inhibitor and cediranib is an anti-angiogenic agent with activity against VEGF receptor ( VEGFR ) 1 , VEGFR2 , and VEGFR3 .
BACKGROUND	Both oral agents have antitumour activity in women with recurrent ovarian cancer , and their combination was active and had manageable toxicities in a phase 1 trial .
BACKGROUND	We investigated whether this combination could improve progression-free survival ( PFS ) compared with olaparib monotherapy in women with recurrent platinum-sensitive ovarian cancer .
METHODS	In our randomised , open-label , phase 2 study , we recruited women ( aged 18 years ) who had measurable platinum-sensitive , relapsed , high-grade serous or endometrioid ovarian , fallopian tube , or primary peritoneal cancer , or those with deleterious germline BRCA1/2 mutations from nine participating US academic medical centres .
METHODS	We randomly allocated participants ( 1:1 ) according to permuted blocks , stratified by germline BRCA status and previous anti-angiogenic therapy , to receive olaparib capsules 400 mg twice daily or the combination at the recommended phase 2 dose of cediranib 30 mg daily and olaparib capsules 200 mg twice daily .
METHODS	The primary endpoint was progression-free survival analysed in the intention-to-treat population .
METHODS	The phase 2 trial is no longer accruing patients .
METHODS	An interim analysis was conducted in November , 2013 , after 50 % of expected events had occurred and efficacy results were unmasked .
METHODS	The primary analysis was performed on March 31 , 2014 , after 47 events ( 66 % of those expected ) .
METHODS	The trial is registered with ClinicalTrials.gov , number NCT01116648 .
RESULTS	Between Oct 26 , 2011 , and June 3 , 2013 , we randomly allocated 46 women to receive olaparib alone and 44 to receive the combination of olaparib and cediranib .
RESULTS	Median PFS was 177 months ( 95 % CI 147-not reached ) for the women treated with cediranib plus olaparib compared with 90 months ( 95 % CI 57-165 ) for those treated with olaparib monotherapy ( hazard ratio 042 , 95 % CI 023-076 ; p = 0005 ) .
RESULTS	Grade 3 and 4 adverse events were more common with combination therapy than with monotherapy , including fatigue ( 12 patients in the cediranib plus olaparib group vs five patients in the olaparib monotherapy group ) , diarrhoea ( ten vs none ) , and hypertension ( 18 vs none ) .
CONCLUSIONS	Cediranib plus olaparib seems to improve PFS in women with recurrent platinum-sensitive high-grade serous or endometrioid ovarian cancer , and warrants study in a phase 3 trial .
CONCLUSIONS	The side-effect profile suggests such investigations should include assessments of quality of life and patient-reported outcomes to understand the effects of a continuing oral regimen with that of intermittent chemotherapy .
BACKGROUND	American Recovery and Reinvestment Act grant from the National Institutes of Health ( NIH ) ( 3 U01 CA062490-16S2 ) ; Intramural Program of the Center for Cancer Research ; and the Division of Cancer Treatment and Diagnosis , National Cancer Institute , NIH .

###25533977
OBJECTIVE	To compare the clinical efficacies of single segment transforaminal lumbar interbody fusion ( TLIF ) with cage versus autogenous morselized bone for degenerative lumbar spinal stenosis .
METHODS	A total of 87 patients undergoing single segment TLIF were randomly divided into 2 groups .
METHODS	A cage was implanted into intervertebral space in group A patients while autogenous morselized bone in group B patients .
METHODS	Operative duration , blood loss , length of stay and cost of hospitalization of two groups were recorded .
METHODS	They were followed up at 1 week , 12 , 24 months post-operation .
METHODS	Oswestry disability index ( ODI ) , visual analogue scale ( VAS ) fusion rates , intervertebral space and foramen height restoration , lumbar lordosis and postoperative complications were compared between two groups .
RESULTS	No significant inter-group difference existed in operative duration , blood loss or length of stay .
RESULTS	However , the average hospitalization cost in group A were 18 % higher than that of group B ( P < 0.05 ) .
RESULTS	Both groups achieved excellent clinical outcomes within 2 years .
RESULTS	ODI , VAS score improvement rates and postoperative complication rates were not statistically different .
RESULTS	Lumbar fusion rate was 86.7 % in group A versus 85.7 % in group B after 2 years .
RESULTS	And there was no significant difference ( P > 0.05 ) .
RESULTS	The heights of intervertebral space and foramen in group A achieved a better recovery than those of group B. Both groups had similar improvements of lumbar lordosis .
CONCLUSIONS	For degenerative lumbar spinal stenosis , usage of interbody cage is more effective in terms of recovery of intervertebral space and foraminal height compared with usage of bone graft .
CONCLUSIONS	However it brings no better clinical efficacy while the usage of autogenous morselized bone is more cost-effective .
CONCLUSIONS	Two grafting methods yield similar overall clinical outcomes .

###25007003
OBJECTIVE	To study the efficacy and safety of quetiapine-XR as monotherapy or adjunctive therapy to a mood stabilizer in acute bipolar I or II depression with comorbid generalized anxiety disorder ( GAD ) and other comorbidities .
METHODS	The study was conducted from January 2007 to November 2011 .
METHODS	The Mini-International Neuropsychiatric Interview was used to ascertain the diagnosis of DSM-IV bipolar disorder , GAD , and other Axis I disorders .
METHODS	Eligible patients were randomly assigned to quetiapine-XR or placebo for up to 8 weeks .
METHODS	The Hamilton Depression Rating Scale-17 items ( HDRS-17 ) was used as a primary outcome to evaluate the difference between the 2 groups using the change from baseline to end of study .
METHODS	Last observation carried forward and mixed-effects modeling for repeated measures were used to analyze the primary and secondary outcome measures .
RESULTS	Of the 120 patients screened , 100 patients were randomized to receive quetiapine-XR ( n = 50 ) or placebo ( n = 50 ) .
RESULTS	Twenty-six patients in the quetiapine-XR and 18 in the placebo group completed the study .
RESULTS	The mean quetiapine-XR dose was 276 50 mg/d ( 50-300 mg/d ) .
RESULTS	There was no significant difference between the 2 groups in the change from baseline to end of study in HDRS-17 total score with an effect size of 0.19 favoring quetiapine-XR .
RESULTS	There were also no significant differences between the 2 groups in secondary efficacy and safety outcome measures .
CONCLUSIONS	Quetiapine-XR was not significantly superior to placebo in bipolar I or II depression with GAD and other comorbidities , suggesting that data from relatively `` pure '' bipolar patients may not be generalizable to a highly comorbid population .
BACKGROUND	ClinicalTrials.gov identifier : NCT00671853 .

###24450776
OBJECTIVE	This study determined the association of continuous glucose monitoring glucose ( CGM-glucose ) levels at different times of the day with improvement in glycated hemoglobin ( HbA1c ) levels .
OBJECTIVE	The potential application of these data is to focus effort to improve glucose control in patients with type 1 diabetes .
METHODS	Data were analyzed from 196 patients with type 1 diabetes who were randomized to receive sensor-augmented pump therapy in the 1-year STAR 3 trial .
METHODS	CGM-glucose values and HbA1c levels from baseline and after 1 year were evaluated to determine associations of improvement in CGM-glucose at different times of the day with longitudinal improvement in HbA1c .
RESULTS	Improvement in HbA1c levels after 1 year was related to improvement in mean CGM-glucose levels in daytime ( 6 a.m.-midnight ) , overnight ( midnight-6 a.m. ) , and each mealtime period ( P < 0.0001 for each ) .
RESULTS	In multivariable analysis , only improvement in breakfast meal period was associated with improvement in HbA1c after 1 year , explaining 59 % of the HbA1c improvement using the partial R ( 2 ) test .
RESULTS	Moreover , among those patients who only improved CGM-glucose in the overnight period there was an associated improvement in breakfast meal period CGM-glucose of 26 22 mg/dL ( P < 0.01 ) .
CONCLUSIONS	Breakfast period glucose improvement had the greatest effect on lowering HbA1c levels in patients with type 1 diabetes .
CONCLUSIONS	Improving glucose control overnight resulted in subsequent improvement in the breakfast period .
CONCLUSIONS	Although glucose control should be improved at all times , methods to improve overnight and post-breakfast glucose levels may be of primary importance in improving glucose control in patients with type 1 diabetes .

###24470004
OBJECTIVE	To evaluate yoga 's impact on inflammation , mood , and fatigue .
METHODS	A randomized controlled 3-month trial was conducted with two post-treatment assessments of 200 breast cancer survivors assigned to either 12 weeks of 90-minute twice per week hatha yoga classes or a wait-list control .
METHODS	The main outcome measures were lipopolysaccharide-stimulated production of proinflammatory cytokines interleukin-6 ( IL-6 ) , tumor necrosis factor alpha ( TNF - ) , and interleukin-1 ( IL-1 ) , and scores on the Multidimensional Fatigue Symptom Inventory-Short Form ( MFSI-SF ) , the vitality scale from the Medical Outcomes Study 36-item Short Form ( SF-36 ) , and the Center for Epidemiological Studies-Depression ( CES-D ) scale .
RESULTS	Immediately post-treatment , fatigue was not lower ( P > .05 ) but vitality was higher ( P = .01 ) in the yoga group compared with the control group .
RESULTS	At 3 months post-treatment , fatigue was lower in the yoga group ( P = .002 ) , vitality was higher ( P = .01 ) , and IL-6 ( P = .027 ) , TNF - ( P = .027 ) , and IL-1 ( P = .037 ) were lower for yoga participants compared with the control group .
RESULTS	Groups did not differ on depression at either time ( P > .2 ) .
RESULTS	Planned secondary analyses showed that the frequency of yoga practice had stronger associations with fatigue at both post-treatment visits ( P = .019 ; P < .001 ) , as well as vitality ( P = .016 ; P = .0045 ) , but not depression ( P > .05 ) than simple group assignment ; more frequent practice produced larger changes .
RESULTS	At 3 months post-treatment , increasing yoga practice also led to a decrease in IL-6 ( P = .01 ) and IL-1 ( P = .03 ) production but not in TNF - production ( P > .05 ) .
CONCLUSIONS	Chronic inflammation may fuel declines in physical function leading to frailty and disability .
CONCLUSIONS	If yoga dampens or limits both fatigue and inflammation , then regular practice could have substantial health benefits .

###24525690
OBJECTIVE	Topiramate has been shown to reduce drinking and heavy drinking in individuals with alcohol dependence whose goal was to stop drinking .
OBJECTIVE	The authors evaluated the efficacy and tolerability of topiramate in heavy drinkers whose treatment goal was to reduce drinking to safe levels .
METHODS	A total of 138 individuals ( 62.3 % men ) were randomly assigned to receive 12 weeks of treatment with topiramate ( N = 67 ) , at a maximal daily dose of 200 mg , or matching placebo ( N = 71 ) .
METHODS	Both groups received brief counseling to reduce drinking and increase abstinent days .
METHODS	It was hypothesized that topiramate-treated patients would be better able to achieve these goals , and it was predicted that based on prior research , the effects would be moderated by a single nucleotide polymorphism ( rs2832407 ) in GRIK1 , encoding the kainate GluK1 receptor subunit .
RESULTS	The rate of treatment completion was 84.9 % and equal by treatment group .
RESULTS	Topiramate treatment significantly reduced heavy drinking days and increased abstinent days relative to placebo .
RESULTS	Patients receiving topiramate also had lower concentrations of the liver enzyme - glutamyl transpeptidase and lower scores on a measure of alcohol-related problems than the placebo group .
RESULTS	In a European American subsample ( N = 122 ) , topiramate 's effect on heavy drinking days was significantly greater than that for placebo only in rs2832407 C-allele homozygotes .
CONCLUSIONS	These findings support the use of topiramate at a daily dose of 200 mg to reduce heavy drinking in problem drinkers .
CONCLUSIONS	The moderator effect of rs2832407 , if validated , would facilitate the identification of heavy drinkers who are likely to respond well to topiramate treatment and provide an important personalized treatment option .
CONCLUSIONS	The pharmacogenetic findings also implicate the kainate receptor in the mechanism of topiramate 's effects on heavy drinking .

###24916909
OBJECTIVE	A response-adaptive randomization ( RAR ) trial design actively adjusts the ratio of participants assigned to each trial arm , favoring the better performing treatment by using outcome data from participants already in the trial .
OBJECTIVE	Compared with a standard clinical trial , an RAR study design has the potential to improve patient participation in acute stroke trials .
METHODS	This cross-sectional randomized survey included adult emergency department patients , age18 , without symptoms of stroke or other critical illness .
METHODS	A standardized protocol was used , and subjects were randomized to either an RAR or standard hypothetical acute stroke trial .
METHODS	After viewing the video describing the hypothetical trial ( http://youtu.be/cKIWduCaPZc ) , reviewing the consent form , and having questions answered , subjects indicated whether they would consent to the trial .
METHODS	A multivariable logistic regression model was fitted to estimate the impact of RAR while controlling for demographic factors and patient understanding of the design .
RESULTS	A total of 418 subjects ( 210 standard and 208 RAR ) were enrolled .
RESULTS	All baseline characteristics were balanced between groups .
RESULTS	There was significantly higher participation in the RAR trial ( 67.3 % ) versus the standard trial ( 54.5 % ) , absolute increase : 12.8 % ( 95 % confidence interval , 3.7-22 .2 ) .
RESULTS	The RAR group had a higher odds ratio of agreeing to research ( odds ratio , 1.89 ; 95 % confidence interval , 1.2-2 .9 ) while adjusting for patient level factors .
RESULTS	Trial designs were generally well understood by the participants .
CONCLUSIONS	The hypothetical RAR trial attracted more research participation than standard randomization .
CONCLUSIONS	RAR has the potential to increase recruitment and offer benefit to future trial participants .

###24887229
BACKGROUND	Blood supplies in Greece are insufficient to meet the high transfusion needs arising from car accidents and treatment of thalassaemia .
BACKGROUND	This study was designed to determine Greeks ' opinions about blood donation , in order to identify the reasons for the lack of motivation to donate and allow experts to establish better recruitment campaigns for the enrichment of the donor pool , based on our findings .
METHODS	The opinions of randomly selected Greek citizens ( n = 800 ) about volunteer blood donation were assessed by means of a standardised , anonymous questionnaire .
METHODS	The results were analysed using the ( 2 ) test and Spearman 's correlation coefficient .
RESULTS	With regards to attitudes towards intention to donate , only 7.1 % were indifferent , while 88.0 % of the individuals believed that donating blood was an `` offer '' .
RESULTS	Reasons for not donating mainly involved safety ( 36.0 % ) and fear ( 24.0 % ) , whereas need ( 77.9 % ) was the most fundamental positive motivation .
RESULTS	Of the people enrolled in the present study , 10.0 % were active donors , 31.3 % occasional donors , 15.0 % rare donors and 36.6 % non-donors .
CONCLUSIONS	The considerable percentages of occasional and rare donors in comparison with the low proportion of active donors in the Greek donor pool indicates that `` need '' is a more important motivation for blood donation than altruism in Greece .
CONCLUSIONS	These results could be useful for establishing advertising campaigns on blood donation and for a more direct approach to the population , aiming for a change in mentality in favour of active blood donation .

###24726210
BACKGROUND	Angiotensin receptor antagonists ( ARBs ) improve outcomes in patients with heart failure ( HF ) with reduced left ventricular ejection fraction , but may induce hyperkalemia ( HK ) and/or a worsening of renal function ( WRF ) .
RESULTS	The incidence and risk factors of HK and its inter-relationship with WRF , as well as associations with clinical outcome ( death or admission for HF i.e. the primary outcome ) in 3846 HF patients enrolled in the double blind HEAAL trial ( losartan 150 mg/d vs. 50 mg/d ) were assessed .
RESULTS	Worsening of renal function was defined as a decrease in eGFR > 20 % from baseline and HK as serum K > 5.5 or > 5 mmol/L .
RESULTS	Higher dose of losartan increased serum potassium .
RESULTS	Episodes of HK > 5 mmol/L or WRF occurred at least once in about half of the patients .
RESULTS	WRF was associated with higher occurrence of HK ( HR 1.19 ( 1.06-1 .34 ) ) and vice versa ( HR 1.35 ( 1.19-1 .53 ) ) , but preceded HK in only about half of the events .
RESULTS	High dose losartan improved outcome despite more frequent WRF and HK , both being independently associated with adverse outcomes in multivariate analyses .
CONCLUSIONS	HK and WRF are common in HF patients .
CONCLUSIONS	Both can be predicted from baseline risk factors and are therefore potentially preventable .
CONCLUSIONS	Although associated with worse outcome , occurrence of any does not hinder the efficacy of high dose losartan .
CONCLUSIONS	HK was associated with WRF and worse outcomes .
CONCLUSIONS	Whether therapy targeting specifically HK may maximize the survival benefit derived from renin angiotensin aldosterone inhibitor use should be appropriately tested in future trials .

###24565293
OBJECTIVE	We aimed to investigate the effect of 21 % and 40 % oxygen supplementation on maternal and neonatal oxidative stress in elective cesarean section ( CS ) under spinal anesthesia .
METHODS	Eighty term parturients undergoing elective CS under spinal anesthesia were enrolled in the study .
METHODS	We allocated patients randomly to breathe 21 % ( air group ) or 40 % ( oxygen group ) oxygen from the time of skin incision until the end of the operation .
METHODS	We collected maternal pre - and post-operative and umbilical artery ( UA ) blood samples .
METHODS	Total antioxidant capacity ( TAC ) , total oxidant status ( TOS ) and the oxidative stress index ( OSI ) were measured .
RESULTS	Age , weight , height , parity , gestation week , spinal-skin incision time , skin incision-delivery time , delivery time , operation time , 1 ( st ) and 5 ( th ) minutes Apgar scores , and birth weight were similar between the groups ( p > 0.05 for all comparisons ) .
RESULTS	There were no differences in preoperative TAC , TOS , or OSI levels between the groups ( p > 0.05 for all comparisons ) .
RESULTS	Postoperative maternal TAC , TOS and OSI levels significantly increased in the oxygen group ( p = 0.047 , < 0.001 and 0.038 , respectively ) ; umbilical artery TAC levels significantly increased in the oxygen group ( p = 0.003 ) ; and umbilical artery TOS and OSI levels significantly increased in the air group ( p = 0.02 and < 0.001 , respectively ) .
CONCLUSIONS	The difference in impact on maternal and fetal oxidative stress of supplemental 40 % compared to 21 % oxygen mandates further large-scale studies that investigate the role of oxygen supplementation during elective CS under spinal anesthesia .

###25675664
OBJECTIVE	We compared the effects of preincisional peritonsillar infiltration of 5 ml levobupivacaine hydrochloride ( 50 mg/10 ml ) on bleeding during surgery and pain after tonsillectomy in patients aged 16 years or older .
METHODS	The study was conducted in 44 adult patients who underwent tonsillectomy .
METHODS	These patients were randomized to either the study group ( SG ) who received levobupivacaine infiltration to the peritonsillary fossae prior to surgery , or a control group ( CG ) treated with 0.9 % sodium chloride infiltration to the peritonsillary fossae prior to incision .
METHODS	The volume of intraoperative bleeding was recorded .
METHODS	Pain was evaluated using a visual analogue scale ( VAS ) .
METHODS	The first pain score was assessed immediately after arriving in the postoperative care unit .
METHODS	VAS scores were subsequently re-assessed 2 , 4 , 8 , 12 , and 24 hours postoperatively .
METHODS	The first analgesic requirement was assessed 24 hours postoperatively .
RESULTS	The pain relieving effect in the levobupivacaine group was statistically significant 2 , 4 , 12 , and 24 hours postoperatively ( p 0.05 ) , but there was no difference in VAS scores between groups at the first and 8-hour postoperative assessments .
RESULTS	There were no differences between the two groups regarding analgesic requirements .
RESULTS	The difference between the mean intraoperative blood loss in the SG and CG was statistically significant ( p 0.05 ) .
RESULTS	No serious complications were observed in either group .
CONCLUSIONS	Preincisional levobupivacaine infiltration seems to be a safe and easily applied medication for postoperative pain control , and decreased the volume of intraoperative blood loss in adult patients after tonsillectomy .

###25693050
BACKGROUND	Less than one-third of HIV-infected pregnant women eligible for combination antiretroviral therapy ( ART ) globally initiate treatment prior to delivery , with lack of access to timely CD4 results being a principal barrier .
BACKGROUND	We evaluated the effectiveness of an SMS-based intervention to improve access to timely antenatal ART .
METHODS	We conducted a stepped-wedge cluster randomized trial of a low-cost programmatic intervention in 20 antenatal clinics in Gaborone , Botswana .
METHODS	From July 2011-April 2012 , 2 clinics were randomly selected every 4 weeks to receive an ongoing clinic-based educational intervention to improve CD4 collection and to receive CD4 results via an automated SMS platform with active patient tracing .
METHODS	CD4 testing before 26 weeks gestation and ART initiation before 30 weeks gestation were assessed .
RESULTS	Three-hundred-sixty-six ART-nave women were included , 189 registering for antenatal care under Intervention and 177 under Usual Care periods .
RESULTS	Of CD4-eligible women , 100 ( 59.2 % ) women under Intervention and 79 ( 50.6 % ) women under Usual Care completed CD4 phlebotomy before 26 weeks gestation , adjusted odds ratio ( aOR , adjusted for time that a clinic initiated Intervention ) 0.87 ( 95 % confidence interval [ CI ] 0.47-1 .63 , P = 0.67 ) .
RESULTS	The SMS-based platform reduced time to clinic receipt of CD4 test result from median of 16 to 6 days ( P < 0.001 ) , was appreciated by clinic staff , and was associated with reduced operational cost .
RESULTS	However , rates of ART initiation remained low , with 56 ( 36.4 % ) women registering under Intervention versus 37 ( 24.2 % ) women under Usual Care initiating ART prior to 30 weeks gestation , aOR 1.06 ( 95 % CI 0.53-2 .13 , P = 0.87 ) .
CONCLUSIONS	The augmented SMS-based intervention delivered CD4 results more rapidly and efficiently , and this type of SMS-based results delivery platform may be useful for a variety of tests and settings .
CONCLUSIONS	However , the intervention did not appear to improve access to timely antenatal CD4 testing or ART initiation , as obstacles other than CD4 impeded ART initiation during pregnancy .

###25752116
OBJECTIVE	To observe the clinical efficacy of nasal vestibule eczema by using beclomethasone dipropionate in combination with He-Ne laser therapy .
METHODS	The 200 cases of nasal vestibule eczema patients were randomly divided into treatment and control groups .
METHODS	The control group received the rub beclomethasone dipropionate cream treatment one time per day .
METHODS	The treatment group supplemented with He-Ne laser irradiation treatment on the basis of the control group on the same treatment , alsoone time per day .
METHODS	Then the results were analyzed .
RESULTS	The total effective rate was 100.0 % in treatment group , while 75.0 % in the control group .
RESULTS	The difference between the two groups was statistically significant ( P < 0.05 ) .
CONCLUSIONS	Beclomethasone dipropionate cream combined with He-Ne laser irradiation therapy on nasal vestibule eczema is significant , and easily to operate , with significant anti-inflammatory , anti-itch , analgesic effects .

###24662777
OBJECTIVE	Investigating the effects of lipid-lowering drugs on HDL subclasses has shown ambiguous results .
OBJECTIVE	This study assessed the effects of ezetimibe , simvastatin , and their combination on HDL subclass distribution .
METHODS	A single-center randomized parallel 3-group open-label study was performed in 72 healthy men free of cardiovascular disease with a baseline LDL-cholesterol of 11130 mg/dl ( 2.90.8 mmol/l ) and a baseline HDL-cholesterol of 6415 mg/dl ( 1.70.4 mmol/l ) .
METHODS	They were treated with ezetimibe ( 10 mg/day , n = 24 ) , simvastatin ( 40 mg/day , n = 24 ) or their combination ( n = 24 ) for 14 days .
METHODS	Blood was drawn before and after the treatment period .
METHODS	HDL subclasses were determined using polyacrylamide gel-tube electrophoresis .
METHODS	Multivariate regression models were used to determine the influence of treatment and covariates on changes in HDL subclass composition .
RESULTS	Baseline HDL subclasses consisted of 3310 % large , 486 % intermediate and 198 % small HDL .
RESULTS	After adjusting for baseline HDL subclass distribution , body mass index , LDL-C and the ratio triglycerides/HDL-C , there was a significant increase in large HDL by about 3.9 percentage points ( P < 0.05 ) and a decrease in intermediate HDL by about 3.5 percentage points ( P < 0.01 ) in both simvastatin-containing treatment arms in comparison to ezetimibe .
RESULTS	The parameters obtained after additional adjustment for the decrease in LDL-C indicated that about one third to one half of these effects could be explained by the extent of LDL-C-lowering .
CONCLUSIONS	In healthy men , treatment with simvastatin leads to favorable effects on HDL subclass composition , which was not be observed with ezetimibe .
CONCLUSIONS	Part of these differential effects may be due to the stronger LDL-C-lowering effects of simvastatin .
BACKGROUND	ClinicalTrials.gov NCT00317993 .

###24817294
OBJECTIVE	The aim of this study is to evaluate the effects of calisthenic exercises on balance , walking speed , fatigue , quality of life , and psychological status in patients with Multiple Sclerosis ( MS ) .
METHODS	Forty patients diagnosed with MS were randomized into two exercise groups ( group 1 = hospital-based , group 2 = home-based ) .
METHODS	Outcome measures including the MS International Quality of Life Scale , 10-meter walking test , Berg Balance Scale , Fatigue Severity Scale and the Hospital Anxiety Depression Inventory were assessed at the baseline and at 12-weeks .
RESULTS	Thirty-six participants completed the exercise programme ( hospital based = 16 , home based = 20 ) .
RESULTS	The mean age was 32.83 3.64 years .
RESULTS	The mean duration of disease was 6.97 3.15 years .
RESULTS	Hospital-based and home-based exercise groups had significant improvements in the balance , 10-meter walking test , anxiety , and the quality of life after the 12-week exercise programme .
RESULTS	There was a significant improvement in the hospital-based patients in terms of the depression scores .
RESULTS	No significant improvement was observed in terms of fatigue in any of the groups .
RESULTS	When both groups were compared , the improvement in the balance and depression scores of the hospital-based patients was significantly higher than the home-based patients .
CONCLUSIONS	Calisthenic exercises can be easily performed both at home and in hospital setting .
CONCLUSIONS	In patients with MS , calisthenic exercises performed at home or at the hospital may improve the balance , quality of life , and the functional and psychological status , while no significant effect has been observed on fatigue .

###24933799
OBJECTIVE	An intra-oral remineralization study was conducted to compare the ability of a dentifrice containing 8 % arginine and calcium carbonate ( Pro-Argin Technology ) , and 1450 ppm fluoride as sodium monofluorophosphate ( MFP ) to remineralize acid-softened bovine enamel specimens compared to a silica-based dentifrice with 1450 ppm fluoride as MFP .
METHODS	The intra-oral clinical study employed a double blind , two-treatment , crossover design , and used an upper palatal retainer to expose the enamel specimens to the oral environment during product use and periods of remineralization .
METHODS	The retainer was designed to house three partially demineralized bovine enamel samples .
METHODS	The study population was comprised of 30 adults , ages 18 to 70 years .
METHODS	The study consisted of two treatment phases with a washout period lasting seven ( + / - three ) days preceding each treatment phase .
METHODS	A silica-based dentifrice without fluoride was used during the washout period .
METHODS	The Test Dentifrice used in this study contained 8 % arginine , calcium carbonate , and 1450 ppm fluoride as sodium monofluorophosphate ( MFP ) .
METHODS	The Control Dentifrice was silica-based and contained 1450 ppm fluoride as MFP .
METHODS	The treatment period consisted of a three-day lead-in period with the assigned product .
METHODS	The panelists brushed two times per day during the three-day lead-in period with the assigned product .
METHODS	On the fourth day , the panelists began brushing with the assigned product with the retainer in their mouth .
METHODS	The panelists brushed for one minute , followed by a one-minute swish with the slurry and a rinse with 15 ml of water in the morning , in the afternoon , and night with the retainer in the mouth .
METHODS	The panelists brushed only their teeth and not the specimens directly .
METHODS	Changes in mineral content before and after treatment were measured using a Knoop microhardness tester .
RESULTS	The results of the study showed that percent remineralization values for the Test Dentifrice and Control Dentifrice were 14.99 % and 8.66 % , respectively .
RESULTS	A statistical analysis showed that the Test Dentifrice was statistically significantly more effective at remineralizing acid-softened enamel in comparison to the Control Dentifrice ( p < 0.05 ) .
CONCLUSIONS	This study demonstrated that the Test Dentifrice with 8 % arginine , calcium carbonate , and 1450 ppm fluoride as MFP is highly effective treatment for promoting remineralization of enamel that has been softened by an erosive challenge .

###24417772
OBJECTIVE	Ritonavir-boosted atazanavir and darunavir are protease inhibitors that are recommended for initial treatment of HIV infection because each has shown better lipid effects and overall tolerability than ritonavir-boosted lopinavir .
OBJECTIVE	The extent to which lipid effects and overall tolerability differ between treatments with atazanavir and darunavir and whether atazanavir-induced hyperbilirubinaemia may result in more favourable metabolic effects are issues that remain to be resolved .
METHODS	A 96-week randomized clinical trial was carried out .
METHODS	The primary endpoint was change in total cholesterol at 24 weeks .
METHODS	Secondary endpoints were changes in lipids other than total cholesterol , insulin sensitivity , total bilirubin , estimated glomerular filtration rate , and CD4 and CD8 cell counts , and the proportion of patients with plasma HIV RNA < 50 HIV-1 RNA copies/mL and study drug discontinuation because of adverse effects at 24 weeks .
METHODS	Analyses were intent-to-treat .
RESULTS	One hundred and seventy-eight patients received once-daily treatment with either atazanavir/ritonavir ( n = 90 ) or darunavir/ritonavir ( n = 88 ) plus tenofovir/emtricitabine .
RESULTS	At 24 weeks , mean total cholesterol had increased by 7.26 and 11.47 mg/dL in the atazanavir/ritonavir and darunavir/ritonavir arms , respectively [ estimated difference -4.21 mg/dL ; 95 % confidence interval ( CI ) -12.11 to +3.69 mg/dL ; P = 0.75 ] .
RESULTS	However , the ratio of total to high-density lipoprotein ( HDL ) cholesterol tended to show a greater decrease with atazanavir/ritonavir compared with darunavir/ritonavir ( estimated difference -1.02 ; 95 % CI -2.35 to +0.13 ; P = 0.07 ) .
RESULTS	Total bilirubin significantly increased with atazanavir/ritonavir ( estimated difference +1.87 mg/dL ; 95 % CI +1.58 to +2.16 mg/dL ; P < 0.01 ) , but bilirubin changes were not associated with lipid changes .
RESULTS	Secondary endpoints other than total bilirubin were not significantly different between arms .
CONCLUSIONS	Atazanavir/ritonavir and darunavir/ritonavir plus tenofovir/emtricitabine did not show significant differences in total cholesterol change or overall tolerability at 24 weeks .
CONCLUSIONS	However , there was a trend towards a lower total to HDL cholesterol ratio with atazanavir/ritonavir and this effect was unrelated to bilirubin .

###25459920
OBJECTIVE	Various healthcare interventions have been launched targeting the growing population of older people .
OBJECTIVE	The objective of this study was to investigate the of a case management intervention for frail old people ( aged 65 + years ) effects on healthcare utilization .
METHODS	The study was conducted in a municipality in southern Sweden and included people aged 65 + years who lived in their ordinary homes , were dependent in two or more activities of daily living ( ADL ) , and had at least two hospital admissions , or four physician visits , in the previous year .
METHODS	One-hundred-fifty-three participants were randomly assigned to either an intervention ( n = 80 ) or a control group ( n = 73 ) .
METHODS	The one-year intervention comprised home visits , at least once a month , by case managers .
METHODS	Group differences were investigated 6-12 and 0-6 months before , and 0-6 and 6-12 months after , baseline .
RESULTS	The intervention group had , compared to the control group , significant lower mean number ( 0.08 vs. 0.37 , p = 0.041 ) and proportion ( 17.4 vs. 46.9 % , p = 0.016 ) of ED visits not leading to hospitalization 6-12 months after baseline .
RESULTS	The intervention group also had a significantly lower mean number of visits to physicians in outpatient care 6-12 months after baseline ( 4.09 vs. 5.29 , p = 0.047 ) .
CONCLUSIONS	The effect on ED visits not leading to hospitalization meant that those in the control group were more likely to visit the ED for reasons that did not require hospitalization , suggesting that they may have been less monitored than the intervention group .
CONCLUSIONS	The intervention has the potential to reduce the burden on outpatient care and ED .

###24289216
OBJECTIVE	Intramuscular ( i.m. ) pethidine is used worldwide for labour analgesia and i.m. diamorphine usage has increased in the UK in the last 15years .
OBJECTIVE	This trial aims to ascertain the relative efficacy and adverse effects of diamorphine and pethidine for labour pain .
METHODS	Prospective , parallel-arm randomised controlled trial with blinding of participants , care-givers and outcome assessors .
METHODS	Maternity units in two District General Hospitals in the UK .
METHODS	After written informed consent , 484 women were randomised and recruited ( 244 diamorphine , 240 pethidine ) .
METHODS	Inclusion criteria included women 16years or older , established labour , singleton pregnancy , 37-42weeks of gestation and weight 60-120kg .
METHODS	On request of i.m. analgesia , participants received either 150mg pethidine or 7.5 mg diamorphine based on computer-generated block randomisation .
METHODS	Maternal-reduction in pain intensity from baseline ( 10-cm visual analogue scale ) at 60minutes and over the 3-hour period after drug administration .
METHODS	Neonatal-requirement for resuscitation and Apgar score at 1minute .
RESULTS	Diamorphine provided modestly improved pain relief at 60minutes , mean difference 1cm ( 95 % confidence interval [ CI ] 0.5-1 .5 ) , and over the 3hours , mean difference 0.7 cm ( 95 % CI 0.3-1 .1 ) .
RESULTS	However , average length of labour in women receiving diamorphine was 82minutes longer ( 95 % CI 39-124 ) and therefore they experienced more pain overall .
RESULTS	There were no statistically significant differences in primary neonatal outcomes .
CONCLUSIONS	There is a modest difference between the analgesia provided by diamorphine or pethidine for labour analgesia but diamorphine is associated with significantly longer labours .

###25125068
BACKGROUND	Persistent knee pain in people over 50 years of age is often attributable to knee osteoarthritis ( OA ) , a common joint condition that causes physical and psychological dysfunction .
BACKGROUND	Exercise and pain coping skills training ( PCST ) can help reduce the impact of persistent knee pain , however , access to health professionals who deliver these services can be challenging .
BACKGROUND	With increasing access to the Internet , remotely delivered Internet-based treatment approaches may provide alternatives for healthcare delivery .
BACKGROUND	This pragmatic randomised controlled trial will investigate whether an Internet-delivered intervention that combines PCST and physiotherapist-guided exercise ( PCST + Ex ) is more effective than online educational material ( educational control ) in people with persistent knee pain .
METHODS	We will recruit 148 people over 50 years of age with self-reported persistent knee pain consistent with knee OA from the Australian community .
METHODS	Following completion of baseline questionnaires , participants will be randomly allocated to access a 3-month intervention of either ( i ) online educational material , or ( ii ) the same online material plus an 8-module ( once per week ) Internet-based PCST program and seven Internet-delivered physiotherapy sessions with a home exercise programs to be performed 3 times per week .
METHODS	Outcomes will be measured at baseline , 3 months and 9 months with the primary time point at 3 months .
METHODS	Primary outcomes are average knee pain on walking ( 11-point numeric rating scale ) and self-reported physical function ( Western Ontario and McMaster Universities Osteoarthritis Index subscale ) .
METHODS	Secondary outcomes include additional measures of knee pain , health-related quality-of-life , perceived global change in symptoms , and potential moderators and mediators of outcomes including self-efficacy for pain management and function , pain coping attempts and pain catastrophising .
METHODS	Other measures of adherence , adverse events , harms , use of health services/co-interventions , and process measures including appropriateness and satisfaction of the intervention , will be collected at 3 , 6 and 9 months .
CONCLUSIONS	The findings will help determine the effectiveness and acceptability of Internet access to a combination of interventions that are known to be beneficial to people with persistent knee pain .
CONCLUSIONS	This study has the potential to guide clinical practice towards innovative modes of healthcare provision .
BACKGROUND	Australian New Zealand Clinical Trials Registry reference : ACTRN12614000243617 .

###25424689
OBJECTIVE	To investigate the efficacy and safety of perindopril-lercanidipine combination versus perindopril or lercanidipine monotherapies in patients with mild essential hypertension .
METHODS	A total of 180 patients with mild essential hypertension were randomly assigned to three groups : group A ( perindopril 2mg plus lercanidipine 5mg ; n = 60 ) , group B ( lercanidipine 10mg ; n = 60 ) and group C ( perindopril 4mg ; n = 60 ) .
METHODS	The treatment efficacy and the incidence of adverse events were evaluated at the end of 4 , 8 and 12 weeks after treatment initiation .
RESULTS	The blood pressure in group A was already lower than in group B and group C at week 4 after treatment initiation .
RESULTS	Systolic blood pressure was 14813mmHg in group A , 15114mmHg in group B , and 15313 in group C ( p < 0.001 ) ; diastolic blood pressure was 898 , 927 and 926mmHg , respectively ( p < 0.001 ) .
RESULTS	At the end of treatment the normalization rate was significantly higher in group A , compared with group B and group C ( 71.7 % , 68.3 % , and 48.3 % , respectively ; p < 0.05 ) .
RESULTS	Four adverse events were observed in group A , while seven and nineteen adverse events occurred in group B and in group C , respectively .
RESULTS	Statistically significant differences in adverse reaction incidence were reported among three groups .
CONCLUSIONS	Although its results were collected in an overall limited number of patients in a single center , this study shows that the combination of perindopril and lercanidipine , compared with lercanidipine alone or perindopril alone , was effective in improving blood pressure in mild essential hypertensive patients , and also decreased the incidence of adverse events .

###25075811
BACKGROUND	Longitudinal changes in awareness in dementia have been studied with short follow-up time and mostly in small patient groups ( including patients with moderate dementia ) .
BACKGROUND	We investigated awareness in patients with mild Alzheimer 's disease ( AD ) over 36 months and studied if a decline in awareness was associated with decline in cognition and increase in neuropsychiatric symptoms .
METHODS	Awareness was measured on a categorical scale in 95 AD patients ( age 50 years , Mini-Mental State Examination ( MMSE ) score 20 ) .
METHODS	Awareness was rated at three time points ( follow-up at 12 and 36 months ) where MMSE , Neuropsychiatric Inventory ( NPI-Q ) , and Cornell scale for Depression in Dementia also were applied .
RESULTS	At 12 months , 26 % had lower awareness rating as compared to baseline and at 36 months lower awareness ratings were found in 39 % .
RESULTS	At both visits , 16 % had higher awareness rating as compared to baseline .
RESULTS	Patients with lower awareness at 36 months as compared to baseline had a more rapid increase in NPI-Q score ( p = 0.002 ) over 36 months as compared to patients with stable or improved awareness over 36 months .
RESULTS	A more rapid decline in MMSE score was observed for patients with lower awareness at 36 months ( as compared to baseline ) but only when compared to patients in whom awareness improved over time .
CONCLUSIONS	The results show essentially no clear relationship between cognitive decline over three years and awareness .
CONCLUSIONS	In some cases , awareness remained stable or even improved despite significant cognitive decline .
CONCLUSIONS	In the subgroup where awareness declined over time , overall ratings of neuropsychiatric symptoms declined more rapidly than in the remaining patients .

###25268437
OBJECTIVE	Hospital readmissions are common and costly , and no single intervention or bundle of interventions has reliably reduced readmissions .
OBJECTIVE	Virtual wards , which use elements of hospital care in the community , have the potential to reduce readmissions , but have not yet been rigorously evaluated .
OBJECTIVE	To determine whether a virtual ward-a model of care that uses some of the systems of a hospital ward to provide interprofessional care for community-dwelling patients-can reduce the risk of readmission in patients at high risk of readmission or death when being discharged from hospital .
METHODS	High-risk adult hospital discharge patients in Toronto were randomly assigned to either the virtual ward or usual care .
METHODS	A total of 1923 patients were randomized during the course of the study : 960 to the usual care group and 963 to the virtual ward group .
METHODS	The first patient was enrolled on June 29 , 2010 , and follow-up was completed on June 2 , 2014 .
METHODS	Patients assigned to the virtual ward received care coordination plus direct care provision ( via a combination of telephone , home visits , or clinic visits ) from an interprofessional team for several weeks after hospital discharge .
METHODS	The interprofessional team met daily at a central site to design and implement individualized management plans .
METHODS	Patients assigned to usual care typically received a typed , structured discharge summary , prescription for new medications if indicated , counseling from the resident physician , arrangements for home care as needed , and recommendations , appointments , or both for follow-up care with physicians as indicated .
METHODS	The primary outcome was a composite of hospital readmission or death within 30 days of discharge .
METHODS	Secondary outcomes included nursing home admission and emergency department visits , each of the components of the primary outcome at 30 days , as well as each of the outcomes ( including the composite primary outcome ) at 90 days , 6 months , and 1 year .
RESULTS	There were no statistically significant between-group differences in the primary or secondary outcomes at 30 or 90 days , 6 months , or 1 year .
RESULTS	The primary outcome occurred in 203 of 959 ( 21.2 % ) of the virtual ward patients and 235 of 956 ( 24.6 % ) of the usual care patients ( absolute difference , 3.4 % ; 95 % CI , -0.3 % to 7.2 % ; P = .09 ) .
RESULTS	There were no statistically significant interactions to indicate that the virtual ward model of care was more or less effective in any of the prespecified subgroups .
CONCLUSIONS	In a diverse group of high-risk patients being discharged from the hospital , we found no statistically significant effect of a virtual ward model of care on readmissions or death at either 30 days or 90 days , 6 months , or 1 year after hospital discharge .
BACKGROUND	clinicaltrials.gov Identifier : NCT01108172 .

###25901481
OBJECTIVE	Remoxy ( Pain Therapeutics , Inc. , Austin , TX ) is an abuse-deterrent formulation of extended-release oxycodone .
OBJECTIVE	The effects of renal or hepatic impairment on the pharmacokinetics ( PK ) of single , oral doses of Remoxy 20 or 10 mg , respectively , were assessed in two phase 1 studies in subjects aged 18-80 years .
METHODS	PK parameters included maximum plasma concentration ( C ( max ) ) and area under the concentration-time curve from time 0 to the last quantifiable concentration ( AUC ( 0-t ) ) , and extrapolated to infinity ( AUCinf ) .
METHODS	Adverse events ( AEs ) were monitored .
RESULTS	Mean ( SD ) oxycodone Cmax values following Remoxy 20-mg administration were 17.6 ( 9.1 ) , 21.9 ( 11.2 ) , 25.9 ( 18.2 ) , and 31.6 ( 14.5 ) ng/mL and AUC0-t values were 210.7 ( 82.1 ) , 271.6 ( 83.3 ) , 299.5 ( 76.3 ) , and 493.5 ( 175.9 ) ngh/mL in subjects with normal or mild ( n = 6 each ) , moderate ( n = 5 ) , and severely impaired renal function ( n = 6 ) , respectively .
RESULTS	Mean ( SD ) oxycodone Cmax following Remoxy 10-mg administration was 7.6 ( 3.3 ) , 7.8 ( 2.3 ) , and 13.1 ( 5.3 ) ng/mL and AUC ( 0-t ) was 105.7 ( 49.5 ) , 134.7 ( 38.3 ) , and 218.0 ( 74.1 ) ngh/mL in subjects with normal , mild , and moderately impaired hepatic function ( n = 6 each ) , respectively .
RESULTS	Differences in exposure values between the different renal and hepatic groups were significant .
RESULTS	Treatment-emergent AEs were reported by 14.3 , 66.7 , 66.7 , and 50.0 percent of subjects with normal , mild , moderate , and severely impaired renal function , respectively , and by 50.0 , 33.3 , and 66.7 percent of subjects with normal , mild , and moderately impaired hepatic function , respectively .
CONCLUSIONS	As renal or hepatic function decreased , oxycodone Cmax and AUC ( 0-t ) were up to approximately twofold higher following single , oral doses of extended-release Remoxy .
CONCLUSIONS	AEs were those typically reported for opioids .
CONCLUSIONS	Lower doses of Remoxy may thus be safely prescribed to subjects with renal or hepatic impairment .

###25858478
BACKGROUND	Idiopathic bile acid malabsorption ( BAM ) has been suggested as a cause of chronic watery diarrhoea , with a response to colestyramine in 70 % of patients .
BACKGROUND	However , the efficacy of this drug has never been investigated in placebo-controlled trials .
OBJECTIVE	To evaluate the efficacy of colestyramine as compared with hydroxypropyl cellulose in the treatment of functional chronic watery diarrhoea .
METHODS	Patients with chronic watery diarrhoea were randomly assigned to groups given colestyramine sachets 4g twice daily ( n = 13 ) or identical hydroxypropyl cellulose sachets ( n = 13 ) for 8weeks .
METHODS	The primary end-point was clinical remission defined as a mean of 3 or fewer stools per day during the week before the visit , with less than 1 watery stool per day .
METHODS	A secondary end-point was the reduction in daily watery stool number .
METHODS	SeHCAT test was performed in all patients , but an abnormal test was not a prerequisite to be included .
RESULTS	All included patients had a SeHCAT 7-day retention 20 % .
RESULTS	There were no statistical differences in the percentage of patients in clinical remission at week 8 between colestyramine and hydroxypropyl cellulose with either intention-to-treat ( 53.8 % vs. 38.4 % ; P = 0.43 ) or per-protocol ( 63.6 % vs. 38.4 % ; P = 0.22 ) analyses .
RESULTS	However , the mean per cent decrease in watery stool number was significantly higher with colestyramine than with hydroxypropyl cellulose ( -92.43.5 % vs. -75.87.1 % ; P = 0.048 ) .
RESULTS	The rate of adverse events related to study drugs did not differ between groups .
CONCLUSIONS	Colestyramine ( 4g twice daily ) is effective and safe for short-term treatment of patients with chronic watery diarrhoea presumably secondary to BAM .
CONCLUSIONS	Clinical Trials Register number EudraCT 2009-011149-14 .

###25490277
BACKGROUND	During puberty , reactivation of the reproductive axis occurs during sleep , with LH pulses specifically tied to deep sleep .
BACKGROUND	This association suggests that deep sleep may stimulate LH secretion , but there have been no interventional studies to determine the characteristics of deep sleep required for LH pulse initiation .
OBJECTIVE	The objective of this study was to determine the effect of deep sleep fragmentation on LH secretion in pubertal children .
METHODS	Studies were performed in a clinical research center .
METHODS	Fourteen healthy pubertal children ( 11.3-14 .1 y ) participated in the study .
METHODS	Subjects were randomized to two overnight studies with polysomnography and frequent blood sampling , with or without deep sleep disruption via auditory stimuli .
RESULTS	An average of 68.1 10.7 ( SE ) auditory stimuli were delivered to interrupt deep sleep during the disruption night , limiting deep sleep to only brief episodes ( average length disrupted 1.3 0.2 min vs normal 7.1 0.8 min , P < .001 ) , and increasing the number of transitions between non-rapid eye movement ( NREM ) , REM , and wake ( disrupted 274.5 33.4 vs normal 131.2 8.1 , P = .001 ) .
RESULTS	There were no differences in mean LH ( normal : 3.2 0.4 vs disrupted : 3.2 0.5 IU/L ) , LH pulse frequency ( 0.6 0.06 vs 0.6 0.07 pulses/h ) , or LH pulse amplitude ( 2.8 0.4 vs 2.8 0.4 IU/L ) between the two nights .
RESULTS	Poisson process modeling demonstrated that the accumulation of deep sleep in the 20 minutes before an LH pulse , whether consolidated or fragmented , was a significant predictor of LH pulse onset ( P < .001 ) .
CONCLUSIONS	In pubertal children , nocturnal LH augmentation and pulse patterning are resistant to deep sleep fragmentation .
CONCLUSIONS	These data suggest that , even when fragmented , deep sleep is strongly related to activation of the GnRH pulse generator .

###24407192
BACKGROUND	Laparoscopic radical cystectomy ( LRC ) is increasingly being used for muscle-invasive bladder cancer .
BACKGROUND	However , high levels of clinical evidence comparing laparoscopic vs open radical cystectomy ( ORC ) are lacking .
METHODS	A prospective randomised controlled clinical trial comparing LRC vs ORC in patients undergoing radical cystectomy for bladder cancer .
METHODS	Thirty-five patients were eligible for final analysis in each group .
RESULTS	The median follow-up was 26 months ( range , 4-59 months ) for laparoscopic vs 32 months ( range , 6-60 months ) for ORC .
RESULTS	Significant differences were noted in operative time , estimated blood loss ( EBL ) , blood transfusion rate , analgesic requirement , and time to resumption of oral intake .
RESULTS	No significant differences were noted in the length of hospital stay , complication rate , lymph node yield ( 14.16.3 for LRC and 15.25.9 for ORC ) , positive surgical margin rate , postoperative pathology , or recurrence rate ( 7 for LRC and 8 for ORC ) .
RESULTS	The 5-year recurrence-free survival with laparoscopic vs ORC was 78.5 % vs 70.9 % , respectively ( P = 0.773 ) .
RESULTS	The overall survival with laparoscopic vs ORC was 73.8 % vs 67.4 % , respectively ( P = 0.511 ) .
CONCLUSIONS	Our study demonstrated that LRC is superior to ORC in perioperative outcomes , including EBL , blood transfusion rate , and analgesic requirement .
CONCLUSIONS	We found no major difference in oncologic outcomes .
CONCLUSIONS	The number of patients is too small to allow for a final conclusion .

###24453078
OBJECTIVE	We present the first study to explore safety and efficacy of the human CD20 monoclonal antibody ofatumumab in relapsing-remitting multiple sclerosis ( RRMS ) .
METHODS	In this randomized , double-blind , placebo-controlled study , patients received 2 ofatumumab infusions ( 100 mg , 300 mg , or 700 mg ) or placebo 2 weeks apart .
METHODS	At week 24 , patients received alternate treatment .
METHODS	Safety and efficacy were assessed .
RESULTS	Thirty-eight patients were randomized ( ofatumumab/placebo , n = 26 ; placebo/ofatumumab , n = 12 ) and analyzed ; 36 completed the study .
RESULTS	Two patients in the 300-mg group withdrew from the study because of adverse events .
RESULTS	No unexpected safety signals emerged .
RESULTS	Infusion-related reactions were common on the first infusion day but not observed on the second infusion day .
RESULTS	None of the patients developed human anti-human antibodies .
RESULTS	Ofatumumab was associated with profound selective reduction of B cells as measured by CD19 ( + ) expression .
RESULTS	New brain MRI lesion activity was suppressed ( > 99 % ) in the first 24 weeks after ofatumumab administration ( all doses ) , with statistically significant reductions ( p < 0.001 ) favoring ofatumumab found in new T1 gadolinium-enhancing lesions , total enhancing T1 lesions , and new and/or enlarging T2 lesions .
CONCLUSIONS	Ofatumumab ( up to 700 mg ) given 2 weeks apart was not associated with any unexpected safety concerns and was well tolerated in patients with RRMS .
CONCLUSIONS	MRI data suggest a clinically meaningful effect of ofatumumab for all doses studied .
CONCLUSIONS	Results warrant further exploration of ofatumumab in RRMS .
METHODS	This study provides Class II evidence that in patients with RRMS , ofatumumab compared with placebo does not increase the number of serious adverse events and decreases the number of new MRI lesions .

###25180702
BACKGROUND	Home exercise can prevent falls in the general older community but its impact in people recently discharged from hospital is not known .
BACKGROUND	The study aimed to investigate the effects of a home-based exercise program on falls and mobility among people recently discharged from hospital .
RESULTS	This randomised controlled trial ( ACTRN12607000563460 ) was conducted among 340 older people .
RESULTS	Intervention group participants ( n = 171 ) were asked to exercise at home for 15-20 minutes up to 6 times weekly for 12 months .
RESULTS	The control group ( n = 169 ) received usual care .
RESULTS	Primary outcomes were rate of falls ( assessed over 12 months using monthly calendars ) , performance-based mobility ( Lower Extremity Summary Performance Score , range 0-3 , at baseline and 12 months , assessor unaware of group allocation ) and self-reported ease of mobility task performance ( range 0-40 , assessed with 12 monthly questionaries ) .
RESULTS	Participants had an average age of 81.2 years ( SD 8.0 ) and 70 % had fallen in the past year .
RESULTS	Complete primary outcome data were obtained for at least 92 % of randomised participants .
RESULTS	Participants in the intervention group reported more falls than the control group ( 177 falls versus 123 falls ) during the 12-month study period and this difference was statistically significant ( incidence rate ratio 1.43 , 95 % CI 1.07 to 1.93 , p = 0.017 ) .
RESULTS	At 12-months , performance-based mobility had improved significantly more in the intervention group than in the control group ( between-group difference adjusted for baseline performance 0.13 , 95 % CI 0.04 to 0.21 , p = 0.004 ) .
RESULTS	Self-reported ease in undertaking mobility tasks over the 12-month period was not significantly different between the groups ( 0.49 , 95 % CI -0.91 to 1.90 , p = 0.488 ) .
CONCLUSIONS	An individualised home exercise prescription significantly improved performance-based mobility but significantly increased the rate of falls in older people recently discharged from hospital .
BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12607000563460 .

###24238896
BACKGROUND	Methicillin-resistant Staphylococcus aureus ( MRSA ) accounts for 10-40 % of hospital-acquired pneumonia , and even more in intensive care units .
BACKGROUND	The current guidelines for the treatment of MRSA nosocomial pneumonia include vancomycin and linezolid .
BACKGROUND	The authors of 2 prospective randomized trials comparing vancomycin and linezolid in nosocomial pneumonia had concluded to the non-inferiority of linezolid .
BACKGROUND	A slight superiority of linezolid was observed in the MRSA pneumonia subgroup , in terms of clinical success and survival , but no definite conclusion could be drawn .
METHODS	A prospective randomized study was made to compare a fixed linezolid dose to dose-optimized vancomycin for the treatment of bacteriologically proven MRSA nosocomial pneumonia ( ZEPHyR Study ) .
RESULTS	Among the 165 patients treated by linezolid ( 57.6 % ) in the PP population , 95 were clinically cured at the end of the study , compared to 81 of the 174 patients treated by vancomycin ( 46.6 % ) ( IC 95 % of the difference 0.5 % -21.6 % , P = 0.042 ) .
RESULTS	Nephrotoxicity in the mITT population reached 8.4 % in the linezolid group compared to 18.2 % in the vancomycin group .
CONCLUSIONS	LNZ was superior to vancomycin for the treatment of MRSA nosocomial pneumonia .

###25196020
BACKGROUND	Early-phase and preclinical studies suggest that moxifloxacin-containing regimens could allow for effective 4-month treatment of uncomplicated , smear-positive pulmonary tuberculosis .
METHODS	We conducted a randomized , double-blind , placebo-controlled , phase 3 trial to test the noninferiority of two moxifloxacin-containing regimens as compared with a control regimen .
METHODS	One group of patients received isoniazid , rifampin , pyrazinamide , and ethambutol for 8 weeks , followed by 18 weeks of isoniazid and rifampin ( control group ) .
METHODS	In the second group , we replaced ethambutol with moxifloxacin for 17 weeks , followed by 9 weeks of placebo ( isoniazid group ) , and in the third group , we replaced isoniazid with moxifloxacin for 17 weeks , followed by 9 weeks of placebo ( ethambutol group ) .
METHODS	The primary end point was treatment failure or relapse within 18 months after randomization .
RESULTS	Of the 1931 patients who underwent randomization , in the per-protocol analysis , a favorable outcome was reported in fewer patients in the isoniazid group ( 85 % ) and the ethambutol group ( 80 % ) than in the control group ( 92 % ) , for a difference favoring the control group of 6.1 percentage points ( 97.5 % confidence interval [ CI ] , 1.7 to 10.5 ) versus the isoniazid group and 11.4 percentage points ( 97.5 % CI , 6.7 to 16.1 ) versus the ethambutol group .
RESULTS	Results were consistent in the modified intention-to-treat analysis and all sensitivity analyses .
RESULTS	The hazard ratios for the time to culture negativity in both solid and liquid mediums for the isoniazid and ethambutol groups , as compared with the control group , ranged from 1.17 to 1.25 , indicating a shorter duration , with the lower bounds of the 95 % confidence intervals exceeding 1.00 in all cases .
RESULTS	There was no significant difference in the incidence of grade 3 or 4 adverse events , with events reported in 127 patients ( 19 % ) in the isoniazid group , 111 ( 17 % ) in the ethambutol group , and 123 ( 19 % ) in the control group .
CONCLUSIONS	The two moxifloxacin-containing regimens produced a more rapid initial decline in bacterial load , as compared with the control group .
CONCLUSIONS	However , noninferiority for these regimens was not shown , which indicates that shortening treatment to 4 months was not effective in this setting .
CONCLUSIONS	( Funded by the Global Alliance for TB Drug Development and others ; REMoxTB ClinicalTrials.gov number , NCT00864383 . )

###25675380
BACKGROUND	Polycystic ovary syndrome ( PCOS ) is an insulin resistance ( IR ) state , like obesity and type 2 diabetes mellitus ( T2DM ) .
BACKGROUND	Although previous studies have suggested a correlation between irisin and the metabolic parameters associated with obesity and T2DM , the results have been inconsistent .
OBJECTIVE	Our objective was to ( 1 ) determine circulating irisin levels in women with PCOS and control subjects , ( 2 ) examine the relationship of irisin and conventional markers of insulin resistance , and ( 3 ) examine irisin changes with interventions modulating IR in PCOS women .
METHODS	This study was comprised of a series of cross-sectional and interventional studies of 178 PCOS and 123 healthy women from the general population and outpatients of the Internal Medicine Department at the Second Affiliated Hospital , Chongqing Medical University , China .
METHODS	Forty seven women with PCOS were randomly assigned to 6 months of oral metformin ( 850 mg bid ) .
METHODS	The oral glucose tolerance test ( OGTT ) and the euglycemic-hyperinsulinemic clamp ( EHC ) were performed to assess glucose tolerance and insulin sensitivity .
METHODS	Outcome measures were IR ( AUC ( Insulin ) and M values ) on an OGTT and EHC , irisin levels , and metabolic markers .
RESULTS	Circulating irisin was significantly higher in both overweight/obese ( body mass index [ BMI ] 25 kg/m ( 2 ) ) and PCOS women ( P < .01 ) .
RESULTS	Circulating irisin levels correlated with BMI , WHR , FAT % , total cholesterol ( TC ) , triglyceride ( TG ) , low-density lipoprotein cholesterol ( LDL-C ) , AUC ( Insulin ) , homeostasis model assessment of insulin resistance ( HOMA2-IR ) , M values , and free androgen index ( FAI ) .
RESULTS	During EHC , short-term hyperinsulinemia exhibited an inhibitory effect on irisin levels .
RESULTS	After 6 months of metformin treatment , there was a significant decrease in circulating irisin in PCOS women following improved IR .
CONCLUSIONS	These data suggest that irisin may be a useful marker of IR in PCOS women .

###25310750
BACKGROUND	Novel and promising results in acne treatment with infrared lasers have been reported .
BACKGROUND	The 1,550-nm erbium glass laser is one of the infrared lasers that may be useful in the treatment of acne .
OBJECTIVE	The aim of this study was to evaluate the efficacy of an erbium glass laser in treatment of active acne and to study the effect of this type of laser on sebaceous glands .
METHODS	Twenty-four patients with active acne lesions were treated using 1,550-nm ( 30-40 mJ ) fractional erbium glass laser .
METHODS	Every patient received 4 sessions with a 2-week interval .
METHODS	Follow-up was done every 3 months for 1 year .
METHODS	The image analyzer computer system was used to measure the sebaceous gland size .
RESULTS	A significant reduction ( p < .0001 ) in the mean count of lesions was observed after treatment and in the follow-up period .
RESULTS	A significant reduction in the size of sebaceous glands was also evident after laser treatment .
CONCLUSIONS	Treatment of active acne with the 1,550-nm erbium glass laser is effective .
CONCLUSIONS	Papules , pustules , and nodules all respond well to therapy .
CONCLUSIONS	The sebaceous gland size decreased significantly , which accounts for the long remission period .

###24275780
OBJECTIVE	The aim of this study was to determine the level of middle ear pressure and alterations in middle ear pressure levels after septoplasty among the individuals having advanced degree isolated nasal septal deviation .
METHODS	A prospective randomized study was conducted .
METHODS	The study included 72 adult patients who had severely deviated septum .
METHODS	The middle ear pressure values at both sides of nasal obstruction and opposite side were determined using tympanometry before the surgery and at postoperative week 3 .
METHODS	The middle ear pressure values were divided into 2 groups , side of nasal obstruction ( group 1 ) and opposite nonaffected side ( group 2 ) .
METHODS	The middle ear pressure values obtained before and after septoplasty were compared .
RESULTS	Before the septoplasty , the median middle ear pressure value was -54 dPa at the side of nasal obstruction , and -46 dPa at the opposite side .
RESULTS	Three weeks after the septoplasty , it was -38 dPa at the side of nasal obstruction , and -40 dPa at the opposite side .
RESULTS	The middle ear pressure improved by approximately 30 % at the side of nasal obstruction and by 11 % at the nonaffected side ; a statistically significant decrease was found at the side of nasal obstruction ( P < 0.05 ) .
CONCLUSIONS	In adult patients with isolated nasal septum deviation , the middle ear pressure is lower at the side of nasal obstruction , but it remains within reference ranges .
CONCLUSIONS	An approximately 30 % improvement occurs in the middle ear pressure after septoplasty .

###25684963
OBJECTIVE	To compare the efficacy and palatability of 4 L polyethylene glycol electrolyte ( PEG ) plus sugar-free menthol candy ( PEG + M ) vs reduced-volume 2 L ascorbic acid-supplemented PEG ( AscPEG ) .
METHODS	In a randomized controlled trial setting , ambulatory patients scheduled for elective colonoscopy were prospectively enrolled .
METHODS	Patients were randomized to receive either PEG + M or AscPEG , both split-dosed with minimal dietary restriction .
METHODS	Palatability was assessed on a linear scale of 1 to 5 ( 1 = disgusting ; 5 = tasty ) .
METHODS	Quality of preparation was scored by assignment-blinded endoscopists using the modified Aronchick and Ottawa scales .
METHODS	The main outcomes were the palatability and efficacy of the preparation .
METHODS	Secondary outcomes included patient willingness to retake the same preparation again in the future and completion of the prescribed preparation .
RESULTS	Overall , 200 patients were enrolled ( 100 patients per arm ) .
RESULTS	PEG + M was more palatable than AscPEG ( 76 % vs 62 % , P = 0.03 ) .
RESULTS	Completing the preparation was not different between study groups ( 91 % PEG + M vs 86 % AscPEG , P = 0.38 ) but more patients were willing to retake PEG + M ( 54 % vs 40 % respectively , P = 0.047 ) .
RESULTS	There was no significant difference between PEG + M vs AscPEG in adequate cleansing on both the modified Aronchick ( 82 % vs 77 % , P = 0.31 ) and the Ottawa scale ( 85 % vs 74 % , P = 0.054 ) .
RESULTS	However , PEG + M was superior in the left colon on the Ottawa subsegmental score ( score 0-2 : 94 % for PEG + M vs 81 % for AscPEG , P = 0.005 ) and received significantly more excellent ratings than AscPEG on the modified Aronchick scale ( 61 % vs 43 % , P = 0.009 ) .
RESULTS	Both preparations performed less well in afternoon vs morning examinations ( inadequate : 29 % vs 15.2 % , P = 0.02 ) .
CONCLUSIONS	4 L PEG plus menthol has better palatability and acceptability than 2 L ascorbic acid - PEG and is associated with a higher rate of excellent preparations ; Clinicaltrial.gov identifier : NCT01788709 .

###25329681
OBJECTIVE	Cough variant asthma ( CVA ) is an important cause of chronic cough , and pathophysiological features of the disease appear to be similar to typical asthma .
OBJECTIVE	Because CVA is recognized as a precursor of asthma , early intervention with long-term anti-inflammatory agents may be recommended .
OBJECTIVE	However , the role of combination therapy with inhaled corticosteroid and 2-agonist in the treatment of CVA has not been elucidated .
OBJECTIVE	To evaluate the effectiveness of the combination therapy , we investigated the clinical impact of regular treatment with salmeterol/fliticasone propionate combination ( SFC ) and inhaled salmeterol ( SAL ) alone in patients with CVA .
METHODS	The study was a randomized , controlled , parallel-group multi-center trial .
METHODS	Forty-three CVA patients were assigned to SFC ( 50/100g once daily ) or SAL ( 50g twice daily ) for 12 weeks .
METHODS	Then , these medications were stopped for the next 24 weeks .
METHODS	Main outcome measures were cough symptoms , pulmonary function and airway inflammation .
RESULTS	Treatment with each of SFC and SAL significantly decreased cough scores and increased FEV1 and PEF , where the efficacy was more pronounced with SFC than SAL .
RESULTS	SFC also decreased sputum eosinophil counts and eosinophil cationic protein contents , whereas SAL had no effect .
RESULTS	After discontinuation of the treatment , cough scores increased , pulmonary function and eosinophilic airway inflammation were aggravated and returned to the baseline levels .
CONCLUSIONS	Maintenance therapy with SFC provides further improvements in cough symptoms , pulmonary function and airway inflammation , and discontinuation of the therapy causes worsening of the disease , indicating that stopping or interrupting anti-inflammatory therapy may not be advisable in patients with CVA .

###25539349
BACKGROUND	Use of acellular dermal matrix in tissue expander breast reconstruction has become a popular adjunct to the total submuscular technique .
BACKGROUND	The question remains as to which matrix , if any , is ideal for breast reconstruction .
METHODS	A randomized trial was conducted to analyze outcomes of immediate staged tissue expander breast reconstruction using either AlloDerm or DermaMatrix .
METHODS	The impact of obesity , radiation , and chemotherapy on complications and biointegration of matrix was investigated .
METHODS	The trial was divided into three stages , with stage I results reported here .
RESULTS	One hundred twenty-eight patients ( 199 breasts ) were randomized equally over 2.5 years .
RESULTS	Most patients were white , healthy nonsmokers .
RESULTS	The overall complication rate was 36.2 percent ; half of the complications were minor .
RESULTS	The AlloDerm and DermaMatrix groups had similar rates of complications ( 33.6 percent versus 38.8 percent ; p = 0.52 ) , consisting mostly of skin necrosis ( 17.8 percent versus 21.4 percent ; p = 0.66 ) and infections ( 13.9 percent versus 16.3 percent ; p = 0.29 ) , both of which led to tissue expander losses ( 5 percent versus 11.2 percent ; p = 0.11 ) .
RESULTS	The AlloDerm group required less time for completion of expansion ( 42 days versus 70 days ; p < 0.001 ) .
RESULTS	Obesity was associated with poor matrix biointegration and a longer drain time , both of which were associated with higher complication rates .
CONCLUSIONS	The Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial is the largest randomized trial to date in matrix breast reconstruction and emphasizes the importance of careful patient and allograft selection to minimize complications .
METHODS	Therapeutic , II .

###24686911
OBJECTIVE	This study was designed to compare acquisition and maintenance of scripts under two conditions : high cue , which provided numerous multimodality cues designed to minimize errors , and low cue , which provided minimal cues .
METHODS	In a randomized controlled crossover study , eight individuals with chronic aphasia received intensive computer-based script training under two cuing conditions .
METHODS	Each condition lasted 3 weeks , with a 3-week washout period .
METHODS	Trained and untrained scripts were probed for accuracy and rate at baseline , during treatment , immediately posttreatment , and at 3 and 6 weeks posttreatment .
METHODS	Significance testing was conducted on gain scores , and effect sizes were calculated .
RESULTS	Training resulted in significant gains in script acquisition with maintenance of skills at 3 and 6 weeks posttreatment .
RESULTS	Differences between cuing conditions were not significant .
RESULTS	When severity of aphasia was considered , there also were no significant differences between conditions , although magnitude of change was greater in the high-cue condition versus the low-cue condition for those with more severe aphasia .
CONCLUSIONS	Both cuing conditions were effective in acquisition and maintenance of scripts .
CONCLUSIONS	The high-cue condition may be advantageous for those with more severe aphasia .
CONCLUSIONS	Findings support the clinical use of script training and the importance of considering aphasia severity .

###25818679
BACKGROUND	Arterial stiffness is associated with elevated blood pressure ( BP ) , but it is unclear whether it also makes hypertension more resistant to treatment .
BACKGROUND	Among hypertensive dialysis patients , this study investigated whether aortic stiffness determines ambulatory BP and predicts its improvement with therapy .
METHODS	Post hoc analysis of the Hypertension in Hemodialysis Patients Treated With Atenolol or Lisinopril ( HDPAL ) trial .
METHODS	179 hypertensive hemodialysis patients with echocardiographic left ventricular hypertrophy .
METHODS	Baseline aortic pulse wave velocity ( PWV ) .
RESULTS	Baseline and treatment-induced change in 44-hour ambulatory BP at 3 , 6 , and 12 months .
METHODS	Aortic PWV was assessed with an echocardiographic-Doppler technique ( ACUSON Cypress , Siemens Medical ) , and 44-hour interdialytic ambulatory BP monitoring was performed with a Spacelabs 90207 monitor .
RESULTS	Mean baseline aortic PWV was 7.62.7 ( SD ) m/s .
RESULTS	Overall treatment-induced changes in ambulatory systolic BP ( SBP ) were -15.620.4 , -18.922.5 , and -20.019.7 mmHg at 3 , 6 , and 12 months .
RESULTS	Changes in SBP were no different among tertiles of baseline PWV .
RESULTS	Aortic PWV was associated directly with baseline ambulatory SBP and pulse pressure ( PP ) and inversely with diastolic BP ( DBP ) .
RESULTS	After adjustment for several cardiovascular risk factors , each 1-m/s higher PWV was associated with 1.34-mm Hg higher baseline SBP ( = 1.340.46 ; P = 0.004 ) and 1.02-mm Hg higher PP ( = 1.020.33 ; P = 0.002 ) , whereas the association with DBP was no longer significant .
RESULTS	Baseline PWV did not predict treatment-induced changes in SBP ( Wald test , P = 0.3 ) and DBP ( Wald test , P = 0.7 ) , but was a predictor of an overall improvement in PP during follow-up ( Wald test , P = 0.03 ) .
CONCLUSIONS	Observational design ; predominantly black patients were studied .
CONCLUSIONS	Because aortic PWV is not a predictor of treatment-induced change in ambulatory BP among hypertensive dialysis patients , it indicates that among these patients , hypertension can be controlled successfully regardless of aortic stiffness .

###24588936
BACKGROUND	The efficacy of pegloticase , a polyethylene glycol ( PEG ) - conjugated mammalian recombinant uricase , approved for chronic refractory gout , can be limited by the development of antibodies ( Ab ) .
BACKGROUND	Analyses from 2 replicate , 6-month , randomized controlled trials were performed to characterize Ab responses to pegloticase .
METHODS	Anti-pegloticase , anti-PEG , and anti-uricase Ab were determined by validated enzyme-linked immunosorbent assays .
METHODS	Ab titers were analyzed for possible relationships with serum pegloticase concentrations , serum uric acid ( sUA ) lowering , and risk of infusion reactions ( IRs ) .
RESULTS	Sixty-nine ( 41 % ) of 169 patients receiving pegloticase developed high titer anti-pegloticase Ab ( > 1:2430 ) and 40 % ( 67/169 ) developed anti-PEG Ab ; 1 patient receiving placebo developed high titer anti-pegloticase Ab .
RESULTS	Only 14 % ( 24/169 ) of patients developed anti-uricase Ab , usually at low titer .
RESULTS	In responders , patients showing sustained UA lowering , mean anti-pegloticase titers at week 25 ( 1:837 1687 with biweekly and 1:2025 4506 with monthly dosing ) were markedly lower than in nonresponders ( 1:34,528 42,228 and 1:89,658 297,797 , respectively ) .
RESULTS	Nonresponder status was associated with reduced serum pegloticase concentrations .
RESULTS	Baseline anti-pegloticase Ab , evident in 15 % ( 31/212 ) of patients , did not predict subsequent loss of urate-lowering response .
RESULTS	Loss of sUA response preceded IRs in 44 of 56 ( 79 % ) pegloticase-treated patients .
CONCLUSIONS	Loss of responsiveness to pegloticase is associated with the development of high titer anti-pegloticase Ab that increase clearance of pegloticase and are associated with a loss of the sUA lowering effect and increased IR risk .
CONCLUSIONS	Pre-infusion sUA can be used as a surrogate for the presence of deleterious anti-pegloticase Ab .
BACKGROUND	NCT00325195 .
BACKGROUND	Registered 10 May 2006 , NCT01356498 .
BACKGROUND	Registered 27 October 2008 .

###25671925
BACKGROUND	Sympathetic response associated with laryngoscopy and endotracheal intubation is recognized as a potential cause for a number of complications especially in coronary bypass surgery patients .
BACKGROUND	Various methods have been used to attenuate these hemodynamic responses , The aim of our study was to compare lidocaine spray in addition to intravenous morphine on attenuating the hemodynamic response to laryngoscopy and endotracheal intubation with intravenous lidocaine and morphine in coronary artery bypass surgery patients .
METHODS	Sixty patients , scheduled for elective coronary bypass grafting surgery were included in this randomized controlled trial .
METHODS	The patients randomly divided in group-A ( Intravenous Morphine 0.1 mg/kg and Intravenous lidocaine 1.5 mg/kg ) and group-B ( Intravenous Morphine 0.1 mg/kg and lidocaine spray 1.5 mg/kg ) .
RESULTS	Demographic data was comparable in both groups .
RESULTS	There was no statistically significant difference between two groups in the duration of laryngoscopy and intubation .
RESULTS	There was statistically insignificant attenuation in heart rate in both groups ( p = 0.134 ) , the trends of attenuation of systolic blood pressure , diastolic blood pressure and mean arterial pressure in group-A compared to group-B ( p = 0.933 ) , ( p = 0.768 ) and ( p = 0.136 ) respectively were statistically insignificant .
CONCLUSIONS	Under the present study design , lidocaine spray in addition to intravenous morphine had no better effect on attenuating the hemodynamic response to laryngoscopy and endotracheal intubation as compared to intravenous lidocaine and morphine in coronary artery bypass surgery patients .

###24289488
OBJECTIVE	To help facilitate economic evaluations of oncology treatments , we mapped responses on cancer-specific instrument to generic preference-based measures .
METHODS	Cancer patients ( n = 367 ) completed one cancer-specific instrument , the FACT-G , and two preference-based measures , the EQ-5D and SF-6D .
METHODS	Responses were randomly divided to form development ( n = 184 ) and cross-validation ( n = 183 ) samples .
METHODS	Relationships between the instruments were estimated using ordinary least squares ( OLS ) , generalized linear models ( GLM ) , and censored least absolute deviations ( CLAD ) regression approaches .
METHODS	The performance of each model was assessed in terms of how well the responses to the cancer-specific instrument predicted EQ-5D and SF-6D utilities using mean absolute error ( MAE ) and root mean squared error ( RMSE ) .
RESULTS	Physical , functional , and emotional well-being domain scores of the FACT-G best explained the EQ-5D and SF-6D .
RESULTS	In terms of accuracy of prediction as measured in RMSE , the CLAD model performed best for the EQ-5D ( RMSE = 0.095 ) whereas the GLM model performed best for the SF-6D ( RMSE = 0.061 ) .
RESULTS	The GLM predicted SF-6D scores matched the observed values more closely than the CLAD and OLS .
CONCLUSIONS	Our results demonstrate that the estimation of both EQ-5D and SF-6D utility indices using the FACT-G responses can be achieved .
CONCLUSIONS	The CLAD model for the EQ-5D and the GLM model for the SF-6D are recommended .
CONCLUSIONS	Thus , it is possible to estimate quality-adjusted life years for economic evaluation from studies where only cancer-specific instrument have been administered .

###25311218
OBJECTIVE	The Children 's Oncology Group study AHOD0031 , a randomized phase III study , was designed to evaluate the role of early chemotherapy response in tailoring subsequent therapy in pediatric intermediate-risk Hodgkin lymphoma .
OBJECTIVE	To avoid treatment-associated risks that compromise long-term health and to maintain high cure rates , dose-intensive chemotherapy with limited cumulative doses was used .
METHODS	Patients received two cycles of doxorubicin , bleomycin , vincristine , etoposide , cyclophosphamide , and prednisone ( ABVE-PC ) followed by response evaluation .
METHODS	Rapid early responders ( RERs ) received two additional ABVE-PC cycles , followed by complete response ( CR ) evaluation .
METHODS	RERs with CR were randomly assigned to involved-field radiotherapy ( IFRT ) or no additional therapy ; RERs with less than CR were nonrandomly assigned to IFRT .
METHODS	Slow early responders ( SERs ) were randomly assigned to receive two additional ABVE-PC cycles with or without two cycles of dexamethasone , etoposide , cisplatin , and cytarabine ( DECA ) .
METHODS	All SERs were assigned to receive IFRT .
RESULTS	Among 1,712 eligible patients , 4-year event-free survival ( EFS ) was 85.0 % : 86.9 % for RERs and 77.4 % for SERs ( P < .001 ) .
RESULTS	Four-year overall survival was 97.8 % : 98.5 % for RERs and 95.3 % for SERs ( P < .001 ) .
RESULTS	Four-year EFS was 87.9 % versus 84.3 % ( P = .11 ) for RERs with CR who were randomly assigned to IFRT versus no IFRT , and 86.7 % versus 87.3 % ( P = .87 ) for RERs with positron emission tomography ( PET ) - negative results at response assessment .
RESULTS	Four-year EFS was 79.3 % versus 75.2 % ( P = .11 ) for SERs who were randomly assigned to DECA versus no DECA , and 70.7 % versus 54.6 % ( P = .05 ) for SERs with PET-positive results at response assessment .
CONCLUSIONS	This trial demonstrated that early response assessment supported therapeutic titration ( omitting radiotherapy in RERs with CR ; augmenting chemotherapy in SERs with PET-positive disease ) .
CONCLUSIONS	Strategies directed toward improved response assessment and risk stratification may enhance tailoring of treatment to patient characteristics and response .

###26094838
OBJECTIVE	Some central hypersomnolence syndromes are associated with a positive allosteric modulator of - aminobutyric acid ( GABA ) - A receptors in cerebrospinal fluid .
OBJECTIVE	Negative allosteric modulators of GABA-A receptors , including clarithromycin , have been reported to reduce sleepiness in these patients .
OBJECTIVE	We sought to systematically assess the effects of clarithromycin on objective vigilance and subjective sleepiness .
METHODS	This was a 5-week , randomized , placebo-controlled , double-blind , crossover trial of clarithromycin 500mg with breakfast and lunch , in patients with hypersomnolence syndromes ( excluding narcolepsy with cataplexy ) and evidence for abnormal cerebrospinal fluid potentiation of GABA-A receptors .
METHODS	The study occurred at a university-affiliated medical center .
METHODS	The primary outcome measure was median reaction time on the psychomotor vigilance task ( PVT ) at week 2 in each condition .
METHODS	Secondary outcomes included the Epworth Sleepiness Scale , Stanford Sleepiness Scale , Functional Outcomes of Sleep Questionnaire , Pittsburgh Sleep Quality Index , SF-36 , and additional PVT measures .
RESULTS	Twenty-three patients began treatment .
RESULTS	Three patients dropped out , and final analyses were performed on 20 complete cases .
RESULTS	Median reaction time was not significantly different between clarithromycin and placebo .
RESULTS	Subjective measures of sleepiness were significantly improved on clarithromycin versus placebo .
RESULTS	Altered taste perception occurred , but was the only side effect more common on clarithromycin than placebo .
RESULTS	No serious adverse events occurred .
CONCLUSIONS	Subjective sleepiness , but not psychomotor vigilance , improved during a 2-week course of clarithromycin .
CONCLUSIONS	Although additional studies are needed , this suggests that clarithromycin may be a reasonable treatment option in patients with treatment-refractory hypersomnolence .
CONCLUSIONS	This trial was registered at ClinicalTrials.gov ( NCT01146600 ) and supported by the American Sleep Medicine Foundation .

###25730930
OBJECTIVE	To report the results of analysis of the economic efficiency of physical rehabilitation of the patients surviving after myocardial infarction with the use of physical exercises .
METHODS	The study included 110 patients ( mean age 58,39,8 years ) who were randomized into two groups : the group where the patients were treated with the use of physical training ( n = 53 ) and the control group ( n = 57 ) .
METHODS	The physical training included natural walking over the level ground at a speed corresponding to 60 % of the maximum heart rate achieved during the initial 6 minute of the walking test .
RESULTS	The results of the analysis indicate that the cost of the full course of medicamental therapy for the patients of the control group was 790.043,83 rubles higher than that for the patients treated with the use of physical exercises .
RESULTS	The expenses for the instrumental and laboratory studies in the former group proved to be 142.776,8 rubles higher than in the latter .
CONCLUSIONS	The inclusion of controlled physical exercises in the program in the rehabilitative treatment of the patients surviving after myocardial infarction makes it possible to achieve a higher quality of their life with the more favourable cost-benefit ratio compared with use of medicamental therapy alone .

###25307886
BACKGROUND	The primary aim of the present study was to evaluate whether usage of self-gripping mesh in open inguinal hernia repair , compared with standard Lichtenstein repair with sutured mesh , could result in a decreased rate of chronic pain at 6-mo follow-up .
BACKGROUND	The secondary outcome was to evaluate foreign body feeling and the quality of life after inguinal hernia repair .
METHODS	The patients were randomized into two study groups as follows : the OLP group received Optilene LP mesh and the PPG group received self-gripping Parietex ProGrip mesh .
METHODS	Pain scores were measured on a visual analog scale .
METHODS	Foreign body feeling was registered as a yes or no question .
METHODS	Quality of life was evaluated using the Medical Outcome Study Short-Form 36 questionnaire .
RESULTS	A total of 75 patients in the OLP group and 70 patients in the PPG group were included in the analysis .
RESULTS	According to the primary end point , 45.3 % and 31.4 % of the patients in the OLP group and PPG group experienced pain during different activities at 6-mo follow-up , respectively ( P = 0.092 ) .
RESULTS	Per secondary end point , 22.7 % in the OLP group and 40 % in the PPG group reported foreign body feeling at the operation site at 6-mo follow-up ( P = 0.031 , risk ratio 0.57 , 95 % confidence interval 0.29-1 .07 ) .
RESULTS	There were no significant differences in any domain of quality of life according to the Short-Form 36 questionnaire between the two study groups at 6-mo follow-up , except for the social functioning domain ( P = 0.035 ) .
RESULTS	In the OLP group , the quality of life scores improved significantly after operation in all domains except for general health and mental health .
RESULTS	In the PPG group , the quality of life scores improved significantly after operation in the domains of bodily pain , physical functioning , and physical role .
CONCLUSIONS	Self-gripping mesh compared with standard Lichtenstein operation has no advantages in reducing chronic pain 6-mo after surgery .
CONCLUSIONS	The rate of foreign body feeling was higher in the self-gripping mesh group .
CONCLUSIONS	Scores of bodily pain , physical functioning , and physical role improved significantly in both study groups after hernia surgery .

###25534295
OBJECTIVE	To perform a subset analysis of patients with very platinum-sensitive recurrent ovarian cancer ( ROC ) enrolled in the phase III CALYPSO trial .
METHODS	The international non-inferiority trial enrolled women with ROC that relapsed > 6 months following first - or second-line platinum - and paclitaxel-based therapies .
METHODS	Patients were randomised to CD [ carboplatin-pegylated liposomal doxorubicin ( PLD ) ] or CP ( carboplatin-paclitaxel ) and stratified by treatment-free interval ( TFI ) .
METHODS	In this analysis , patients with a TFI > 24 months were analysed separately for progression free survival ( PFS ) , the primary endpoint of CALYPSO , overall survival ( OS ) and safety .
RESULTS	A total of 259 very platinum-sensitive patients were included ( n = 131 , CD ; n = 128 , CP ) .
RESULTS	Median PFS was 12.0 months for the CD arm and 12.3 months for CP [ HR = 1.05 ( 95 % CI , 0.79-1 .40 ) ; P = 0.73 for superiority ] and median OS was 40.2 months for CD and 43.9 for CP [ HR = 1.18 ( 95 % CI 0.85-1 .63 ) ; P = 0.33 for superiority ] .
RESULTS	Overall response rates were 42 % and 38 % , respectively ( P = 0.46 ) .
RESULTS	Toxicities were more common with CP versus CD , including grade 3/4 neutropenia ( 40.8 % versus 27.5 % ; P = 0.025 ) , nausea ( 4.8 % versus 3.1 % ; P = 0.47 ) , allergic reaction ( 8 % versus 3.1 % ; P = 0.082 ) sensory neuropathy ( 4.8 % versus 2.3 % ; P = 0.27 ) and grade 2 alopecia ( 88 % versus 9.2 % ; P < 0.001 ) .
RESULTS	Grade 3/4 thrombocytopenia ( 12.2 % versus 3.2 % ; P = 0.007 ) and mucositis ( 2.3 % versus 0 % ; P = 0.089 ) were more common with CD .
RESULTS	Grade 3/4 hand-foot syndrome occurred rarely with CD ( 3 patients versus 0 in CP arm ; P = 0.089 ) .
CONCLUSIONS	CP and CD were equally effective treatment regimens for patients with very platinum-sensitive ROC .
CONCLUSIONS	The favourable risk-benefit profile suggests carboplatin-PLD as treatment of choice for these patients .

###24472622
BACKGROUND	Allocentric navigation declines with age and neurologic disease whereas egocentric navigation does not ; differences that likely arise from maladaptive changes in brain regions mediating spatial ( parietal cortex ; hippocampus ) but not procedural processing ( caudate nucleus ) .
BACKGROUND	Transcranial direct current stimulation ( tDCS ) holds promise for treating such decline given its ability to modulate neuronal excitability , but its effects have yet to be examined on spatial navigation .
OBJECTIVE	Using healthy young adults as a model , Study 1 intended to validate a novel spatial navigation paradigm using functional magnetic resonance imaging ( fMRI ) .
OBJECTIVE	Using these data to determine targets for tDCS , Study 2 aimed to determine if 1 ) stimulation modulates activation in a polarity-specific manner ; 2 ) stimulation results in global and/or task-specific activation changes ; 3 ) activation changes are accompanied by changes in effective connectivity .
METHODS	All participants underwent fMRI while learning allocentric and egocentric environments .
METHODS	Twelve participants completed Study 1 .
METHODS	In Study 2 , 16 participants were randomized to 20 min of tDCS ( 2 mA ) using a montage with the anode over PZ and cathode over AF4 ( P+F - ) or the reverse montage ( P-F + ) .
RESULTS	Study 1 revealed that distinct networks preferentially mediate allocentric and egocentric navigation .
RESULTS	Study 2 revealed polarity-dependent changes in activation and connectivity .
RESULTS	The P+F - montage increased these measures in spatial regions , especially during allocentric navigation , and the caudate nucleus .
RESULTS	Conversely , the P-F + montage increased activation and connectivity in lateral prefrontal cortices and posterior hippocampus .
CONCLUSIONS	These findings support the neuromodulatory effects of tDCS in non-motor areas and demonstrate proof-of-principle for ameliorating age - and disease-related decline in navigational abilities .

###24616307
OBJECTIVE	This study aimed to determine whether feeding back patient-reported outcomes ( PROs ) to providers and families of children with advanced cancer improves symptom distress and health-related quality of life ( HRQoL ) .
METHODS	This study was a parallel , multicentered pilot randomized controlled trial .
METHODS	At most once per week , children age 2 years old with advanced cancer or their parent completed the computer-based Pediatric Quality of Life and Evaluation of Symptoms Technology ( PediQUEST ) survey consisting of age - and respondent-adapted versions of the Memorial Symptom Assessment Scale ( MSAS ) , Pediatric Quality of Life Inventory 4.0 Generic Core Scales ( PedsQL4 .0 ) , and an overall Sickness question .
METHODS	In the intervention group ( n = 51 ) , oncologists and families received printed reports summarizing PROs ; e-mails were sent to oncologists and subspecialists when predetermined scores were exceeded .
METHODS	No feedback was provided in the control group ( n = 53 ) .
METHODS	Primary outcomes included linear trends of MSAS , PedsQL4 .0 total and subscale scores , and Sickness scores during 20 weeks of follow-up , along with child , parent , and provider satisfaction with PediQUEST feedback .
RESULTS	Feedback did not significantly affect average MSAS , PedsQL4 .0 , or Sickness score trends .
RESULTS	Post hoc subgroup analyses among children age 8 years who survived 20 weeks showed that feedback improved PedsQL4 .0 emotional ( +8.1 ; 95 % CI , 1.8 to 14.4 ) and Sickness ( -8.2 ; 95 % CI , -14.2 to -2.2 ) scores .
RESULTS	PediQUEST reports were valued by children , parents , and providers and contributed at least sometimes to physician initiation of a psychosocial consult ( 56 % ) .
CONCLUSIONS	Although routine feedback of PROs did not significantly affect the child 's symptoms or HRQoL , changes were in expected directions and improvements observed in emotional HRQoL through exploratory analyses were encouraging .
CONCLUSIONS	Importantly , children , parents , and providers value PRO feedback .

###26347918
BACKGROUND	Patients with acute ST-segment elevation myocardial infarction ( STEMI ) and multivessel coronary disease have a worse prognosis compared with individuals with single-vessel disease .
BACKGROUND	We aimed to study the clinical outcome of patients with STEMI treated with fractional flow reserve ( FFR ) - guided complete revascularisation versus treatment of the infarct-related artery only .
METHODS	We undertook an open-label , randomised controlled trial at two university hospitals in Denmark .
METHODS	Patients presenting with STEMI who had one or more clinically significant coronary stenosis in addition to the lesion in the infarct-related artery were included .
METHODS	After successful percutaneous coronary intervention ( PCI ) of the infarct-related artery , patients were randomly allocated ( in a 1:1 ratio ) either no further invasive treatment or complete FFR-guided revascularisation before discharge .
METHODS	Randomisation was done electronically via a web-based system in permuted blocks of varying size by the clinician who did the primary PCI .
METHODS	All patients received best medical treatment .
METHODS	The primary endpoint was a composite of all-cause mortality , non-fatal reinfarction , and ischaemia-driven revascularization of lesions in non-infarct-related arteries and was assessed when the last enrolled patient had been followed up for 1 year .
METHODS	Analysis was on an intention-to-treat basis .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01960933 .
RESULTS	From March , 2011 , to February , 2014 , we enrolled 627 patients to the trial ; 313 were allocated no further invasive treatment after primary PCI of the infarct-related artery only and 314 were assigned complete revascularization guided by FFR values .
RESULTS	Median follow-up was 27 months ( range 1244 months ) .
RESULTS	Events comprising the primary endpoint were recorded in 68 ( 22 % ) patients who had PCI of the infarct-related artery only and in 40 ( 13 % ) patients who had complete revascularisation ( hazard ratio 056 , 95 % CI 038083 ; p = 0004 ) .
CONCLUSIONS	In patients with STEMI and multivessel disease , complete revascularisation guided by FFR measurements significantly reduces the risk of future events compared with no further invasive intervention after primary PCI .
CONCLUSIONS	This effect is driven by significantly fewer repeat revascularisations , because all-cause mortality and non-fatal reinfarction did not differ between groups .
CONCLUSIONS	Thus , to avoid repeat revascularisation , patients can safely have all their lesions treated during the index admission .
CONCLUSIONS	Future studies should clarify whether complete revascularization should be done acutely during the index procedure or at later time and whether it has an effect on hard endpoints .
BACKGROUND	Danish Agency for Science , Technology and Innovation and Danish Council for Strategic Research .

###25441567
BACKGROUND	The treatment of adhesive capsulitis is a dilemma for orthopaedic rehabilitation specialists .
BACKGROUND	In this study , we assessed whether extracorporeal shockwave therapy ( ESWT ) improves the functional outcome of primary shoulder adhesive capsulitis .
METHODS	In this prospective , randomized , controlled , single-blind clinical trial , we enrolled 40 patients with primary adhesive capsulitis to assess whether ESWT can improve the functional outcome of primary adhesive capsulitis better than oral steroid therapy .
METHODS	Patients were allocated to the oral steroid group or ESWT group with randomization .
METHODS	Functional outcome evaluations were performed using the Constant Shoulder Score ( CSS ) and Oxford Shoulder Score .
RESULTS	Both groups showed significant improvement in the Oxford Shoulder Score evaluation throughout the study period .
RESULTS	In the ESWT group , the total CSS and range of motion ( ROM ) parameter of the CSS in the ESWT group showed significant improvement from the fourth week that was better than that in the steroid group ; the activitiesofdaily living ( ADL ) parameter of the CSS achieved significance and was better than that in the steroid group at the sixth week .
RESULTS	For the steroid group , pain was significantly reduced from baseline to the fourth week of the study ; ADL and ROM improved at the fourth to 12th week .
RESULTS	For the ESWT group , ADL and ROM improvements were significant from baseline to the sixth week .
CONCLUSIONS	Our results showed that ESWT can be an alternative treatment , at least in the short-term , for primary adhesive capsulitis of the shoulder .
CONCLUSIONS	In addition , all of the side effects of ESWT were transient and tolerable .

###24429129
BACKGROUND	Few treatment options exist for patients with severe emphysema .
BACKGROUND	We assessed the clinical benefits and safety of lung volume reduction coils ( LVRCs ) for the treatment of patients with severe emphysema with hyperinflation .
METHODS	In a randomised study , we recruited patients with severe emphysema ( aged 35 years ) from three centres in the UK .
METHODS	Using a computer-generated randomisation sequence , we randomly allocated patients in a one-to-one ratio ( block sizes of four and stratified by centre ) to either LVRC treatment ( treatment group ) or best medical care ( usual care group ) .
METHODS	The primary endpoint was the difference in response in the St George 's Respiratory Questionnaire ( SGRQ ) between treatment and usual care groups at 90 days after final treatment ( by intention-to-treat analysis ) .
METHODS	The trial is registered with ClinicalTrials.gov , number NCT01334307 .
RESULTS	Between Jan 27 , 2010 , to Oct 25 , 2011 , we recruited and randomly allocated 47 patients : 23 to treatment and 24 to usual care ( 23 patients in each group were included in the intention-to-treat analysis ) .
RESULTS	SGRQ response at 90 days after final treatment was greater in the treatment group than it was in the usual care group ( between-group difference in change from baseline -836 points [ 95 % CI -1624 to -047 ] ; p = 004 ) .
RESULTS	We detected no between-group difference in serious adverse events .
CONCLUSIONS	Our findings suggest that treatment with endobronchial coils can improve quality of life for patients with severe emphysema and hyperinflation .
BACKGROUND	PneumRx .

###26154547
OBJECTIVE	To evaluate the change in respiratory function and functional capacity according to the type of preoperative fasting .
METHODS	Randomized prospective clinical trial , with 92 female patients undergoing cholecystectomy by laparotomy with conventional or 2 hours shortened fasting .
METHODS	The variables measured were the peak expiratory flow , forced expiratory volume in the first second , forced vital capacity , dominant handgrip strength , and non-dominant handgrip strength .
METHODS	Evaluations were performed 2 hours before induction of anesthesia and 24 hours after the operation .
RESULTS	The two groups were similar in preoperative evaluations regarding demographic and clinical characteristics , as well as for all variables .
RESULTS	However , postoperatively the group with shortened fasting had higher values than the group with conventional fasting for lung function tests peak expiratory flow ( 128.762.5 versus 115.759.9 ; p = 0.040 ) , forced expiratory volume in the first second ( 1.50.6 versus 1.20.5 ; p = 0.040 ) , forced vital capacity ( 2.31.1 versus 1.80.9 ; p = 0.021 ) , and for muscle function tests dominant handgrip strength ( 24.96.8 versus 18.47.7 ; p = 0.001 ) and non-dominant handgrip strength ( 22.96.3 versus 17.07.8 ; p = 0.0002 ) .
RESULTS	In the intragroup evaluation , there was a decrease in preoperative compared with postoperative values , except for dominant handgrip strength ( 25.26.7 versus 24.96.8 ; p = 0.692 ) , in the shortened fasting group .
CONCLUSIONS	Abbreviation of preoperative fasting time with ingestion of maltodextrin solution is beneficial to pulmonary function and preserves dominant handgrip strength .

###24874564
BACKGROUND	Wholegrain rye has been associated with decreased hunger sensations .
BACKGROUND	This may be partly mediated by colonic fermentation .
BACKGROUND	Sustained consumption of fermentable components is known to change the gut microflora and may increase numbers of saccharolytic bacteria .
OBJECTIVE	To investigate the effect of wholegrain rye consumption on appetite and colonic fermentation after a subsequent meal .
METHODS	In a randomized , controlled , three-arm cross-over study , twelve healthy male subjects consumed three iso-caloric evening test meals .
METHODS	The test meals were based on white wheat bread ( WBB ) , wholegrain rye kernel bread ( RKB ) , or boiled rye kernels ( RK ) .
METHODS	Breath hydrogen excretion and subjective appetite sensation were measured before and at 30min intervals for 3h after a standardized breakfast in the subsequent morning .
METHODS	After the 3h , an ad libitum lunch meal was served to assess energy intake .
METHODS	In an in vitro study , RKB and RK were subjected to digestion and 24h-fermentation in order to study SCFA production and growth of selected saccharolytic bacteria .
RESULTS	The test meals did not differ in their effect on parameters of subjective appetite sensation the following day .
RESULTS	Ad libitum energy intake at lunch was , however , reduced by 11 % ( P < 0.01 ) after RKB and 7 % ( P < 0.05 ) after RK compared with after WWB evening meal .
RESULTS	Breath hydrogen excretion was significantly increased following RKB and RK evening meals compared with WWB ( P < 0.01 and P < 0.05 , respectively ) .
RESULTS	Overall , RKB and RK were readily fermented in vitro and exhibited similar fermentation profiles , although total SCFA production was higher for RK compared with RKB ( P < 0.001 ) .
RESULTS	In vitro fermentation of RKB and RK both increased the relative quantities of Bifidobacterium and decreased Bacteroides compared with inoculum ( P < 0.001 ) .
RESULTS	The C. coccoides group was reduced after RKB ( P < 0.001 ) .
CONCLUSIONS	Consumption of wholegrain rye products reduced subsequent ad libitum energy intake in young healthy men , possibly mediated by mechanisms related to colonic fermentation .

###25613949
OBJECTIVE	We investigated the safety of a telemetric IOP sensor and the accuracy of its IOP measurements in six patients with open-angle glaucoma and cataract .
METHODS	The study design was a prospective , single-center clinical trial .
METHODS	Here we present 1-year follow-up data .
METHODS	A ring-shaped telemetric IOP sensor was implanted in the ciliary sulcus after implantation of the intracapsular lens , during planned cataract surgery .
METHODS	The sensor is encapsulated in silicone rubber and consists of a miniature device with eight pressure-sensitive capacitors and a circular microcoil antenna .
METHODS	IOP measurements are performed with a reader unit held in front of the eye .
METHODS	IOP is calculated as the differences between the absolute pressure inside the eye ( pressure sensor ) and that outside the eye ( reader unit ) .
RESULTS	The sensor was successfully implanted in all patients .
RESULTS	Four patients developed sterile anterior chamber inflammation that resolved completely within 9 days after surgery with anti-inflammatory treatment .
RESULTS	All patients showed mild to moderate pupillary distortion and pigment dispersion after surgery .
RESULTS	Telemetric IOP measurement was performed in all patients at all visits , and the patients successfully performed self-tonometry at home after receiving instructions .
RESULTS	Telemetric IOP values showed similar profiles compared to those of Goldmann applanation tonometry ( GAT ) .
RESULTS	Three patients showed a relevant IOP step during follow-up , and in one patient , negative values were obtained throughout the study .
CONCLUSIONS	Despite early postoperative anterior chamber inflammation , the IOP sensor was well tolerated by all patients .
CONCLUSIONS	We describe the first prospective clinical study of a noncontact IOP sensor that potentially enables continuous IOP monitoring in patients with glaucoma .
CONCLUSIONS	The sensor shape and size needs to be adapted to avoid pupillary distortion and to confirm that IOP measurements are accurately recorded in comparison to those of GAT .
CONCLUSIONS	( www.germanctr.de ; number DRKS00003335 . )

###24991933
BACKGROUND	Sleep-disturbed breathing ( SDB ) is common in patients with precapillary pulmonary hypertension ( PH ) .
BACKGROUND	Nocturnal oxygen therapy ( NOT ) and acetazolamide improve SDB in patients with PH , and NOT improves exercise capacity .
BACKGROUND	We investigated the effect of NOT and acetazolamide on nocturnal cardiac conduction , repolarization , and arrhythmias in patients with PH and SDB .
METHODS	In a randomized , placebo-controlled , double-blind , crossover trial , 23 patients with arterial ( n = 16 ) or chronic thromboembolic PH ( n = 7 ) and SDB defined as a mean nocturnal oxygen saturation < 90 % or dips ( > 3 % ) > 10/h with daytime Pao2 7.3 kPa were studied .
METHODS	Participants received NOT ( 3 L/min ) , acetazolamide tablets ( 2 250 mg ) , and sham-NOT/placebo each during 1 week separated by a 1-week washout period .
METHODS	Three-lead ECG was recorded during overnight polysomnography at the end of each treatment period .
METHODS	Repolarization indices were averaged over three cardiac cycles at late evening and at early morning , and nocturnal arrhythmias were counted .
RESULTS	NOT was associated with a lower overnight ( 68 10 beats/min vs 72 9 beats/min , P = .010 ) and early morning heart rate compared with placebo .
RESULTS	At late evening , the heart rate-adjusted PQ time was increased under acetazolamide compared with placebo ( mean difference , 10 milliseconds ; 95 % CI , 0-20 milliseconds ; P = .042 ) .
RESULTS	In the morning under NOT , the heart rate-adjusted QT ( QTc ) interval was decreased compared with placebo ( mean difference , -25 milliseconds ; 95 % CI , -45 to -6 milliseconds ; P = .007 ) , and the interval between the peak and the end of the T wave on the ECG was shorter compared with acetazolamide ( mean difference , -11 milliseconds ; 95 % CI , -21 to -1 milliseconds ; P = .028 ) .
RESULTS	Arrhythmias were rare and similar with all treatments .
CONCLUSIONS	In patients with PH with SDB , NOT reduces nocturnal heart rate and QTc in the morning , thus , favorably modifying prognostic markers .
BACKGROUND	ClinicalTrials.gov ; No. : NTC-01427192 ; URL : www.clinicaltrials.gov .

###25087414
OBJECTIVE	The objective of the present work was to study effects of low-level laser irradiation on the endothelial function and selected parameters of microcirculation in the patients presenting with rheumatoid arthritis .
METHODS	This study included 132 patients at the age varying from 18 to 85 years presenting with rheumatoid arthritis .
METHODS	They were divided into 2 groups .
METHODS	The patients of the main group ( n = 102 ) underwent daily intravenous laser blood irradiation during 10 days .
METHODS	The control group was comprised of 30 patients .
METHODS	Laser therapy was performed with the help of a laser therapeutic device Matrix - VLOK ( `` Matrix '' , Russia ) using alternation of two radiating heads : KI-VLOK-63 ( wavelength 0.63 pm , for 15 minutes ) and KI-VLOK-365 ( wavelength 0.365 microm , for 5 minutes ) in the continuous emission regime .
METHODS	The parameters of interest were measured before and after the treatment .
METHODS	The overall duration of intravenous laser irradiation of blood was 10 days without a break for the weekend .
RESULTS	The data obtained suggest the improvement of the endothelial function and the microcirculation indices .

###25312449
BACKGROUND	Few clinical trials in chronic idiopathic constipation ( CIC ) patients have evaluated abdominal symptom severity and whether CIC patients with abdominal symptoms respond similarly to patients with limited abdominal symptoms .
OBJECTIVE	To examine abdominal symptom severity and relationships between symptoms and global measures at baseline ; compare linaclotide 's effect on symptoms in subpopulations with more or less abdominal pain ; and assess relationships between symptom improvement and global measures in these two subpopulations .
METHODS	In two phase 3 trials , patients meeting modified Rome II CIC criteria were assigned to linaclotide 145g , 290g , or placebo once daily .
METHODS	Patients rated abdominal and bowel symptoms daily during 2-week pre-treatment and 12-week treatment periods .
METHODS	Linaclotide 's effect on symptoms and global measures [ constipation severity , health-related quality of life ( HRQOL ) , treatment satisfaction ] and their inter-relationships were assessed in post hoc analyses of abdominal pain subpopulations .
RESULTS	Of 1271 CIC patients , 23 % , 32 % , and 43 % reported moderate-to-severe abdominal pain , discomfort , and bloating , respectively , during baseline .
RESULTS	In more-severe abdominal pain patients , abdominal symptoms were more strongly correlated than bowel symptoms with global measures , but in less-severeabdominal pain patients , abdominal and bowel symptoms were similarly correlated with global measures , at baseline and post-treatment .
RESULTS	Linaclotide significantly improved all symptoms and global measures in both subpopulations .
CONCLUSIONS	When abdominal pain is present in CIC , abdominal and not bowel symptoms may drive patient assessments of constipation severity , HRQOL , and treatment satisfaction .
CONCLUSIONS	Linaclotide ( 145g and 290g ) is an effective treatment for both abdominal and bowel symptoms , even in CIC patients with more severe abdominal pain at baseline .
CONCLUSIONS	( Clinicaltrials.gov : NCT00765882 , NCT00730015 ) .

###25649209
OBJECTIVE	To investigate the safety and efficacy of QMF149 , a once-daily , fixed-dose combination of the long-acting 2-agonist ( LABA ) indacaterol maleate and inhaled corticosteroid ( ICS ) mometasone furoate ( MF ) for the treatment of persistent asthma .
OBJECTIVE	The hypothesis was that QMF149 would not increase the risk of serious asthma exacerbations .
METHODS	174 research centres in nine countries .
METHODS	1519 adolescents and adults with persistent asthma who were treated or qualified for treatment with combination LABA/ICS were randomised , and 1508 were included in the intention-to-treat analysis .
METHODS	Patients were randomised to QMF149 ( indacaterol maleate 500g/MF 400g ) or MF ( 400g ) once daily via Twisthaler inhalation device in a double-blind , parallel-group study for 6-21months .
METHODS	The primary end point was time to first serious asthma exacerbation ( resulting in hospitalisation , intubation or death ) .
METHODS	The key secondary end point was annual rate of exacerbations requiring systemic corticosteroids .
RESULTS	Treatment with QMF149 resulted in no significant difference in time to first serious exacerbation compared to MF ( 2 ( 0.3 % ) vs 6 events ( 0.8 % ) ; difference -0.52 percentage point ; 95 % CI -1.25 to 0.21 , p = 0.160 , HR = 0.31 ; 95 % CI 0.06 to 1.54 , p = 0.151 ) .
RESULTS	QMF149 significantly reduced the annual rate of exacerbations requiring systemic corticosteroids ( rate ratio = 0.71 ; 95 % CI 0.55 to 0.90 , p = 0.005 ) .
RESULTS	Proportions of patients experiencing adverse events were similar across groups ( 74.0 % in the QMF149 group and 73.4 % in the MF group ) .
RESULTS	Serious adverse events occurred in 4 % and 5.8 % of patients in the QMF149 and MF groups , respectively .
CONCLUSIONS	No significant difference was observed in the primary outcome of time to first serious asthma exacerbation in patients treated with QMF149 compared with patients treated with MF .
CONCLUSIONS	Long-term treatment with QMF149 once daily had a favourable safety/efficacy profile in adolescent and adult patients with persistent asthma .
BACKGROUND	ClinicalTrials.gov ; NCT00941798 .

###25470975
OBJECTIVE	To study the clinical effect of Dengzhanhua injection and Xiongqin injection combined with Xuesaitong to treat the elderly patients with acute cerebral infarction .
METHODS	From March 2012 to March 2013,140 patients with acute cerebral infarction elderly patients were treated , as research subjects were randomly divided into two groups , the observation group and the control group ,70 cases in each group .
METHODS	The control group were treated using Xuesaitong ; The observation group using Dengzhanhua injection and Xiongqin injection combined with Xuesaitong .
METHODS	The changes of cerebral blood flow , plasma viscosity and platelet adhesion rate were com - pared before and after the treatment ; Nerve function and living abilities of the two groups were recorded and compared ; Cure rate of the two groups were compared .
RESULTS	The cerebral blood flow , plasma viscosity and platelet adhesion rate had improved to some extent af - ter treatment both of the two groups , the degree of improvement in the observation group was significantly better than the control group ( P < 0.01 ) ; Nerve function and living abilities of the observation group was significantly better than the control group ( P < 0.05 ) ; Cure rate in the observation group was significantly higher than the control group ( P < 0.01 ) .
CONCLUSIONS	Using Dengzhanhua injection and Xiongqin injection combined with Xuesaitong to treat elderly patients with acute cerebral infarction has significantly high curative rate , which can significantly improve patients ' cerebral blood flow , plasma viscosity , platelet adhesion rate , nerve function and life skills .

###25220196
BACKGROUND	Implant migration , bone mineral density ( BMD ) , length of glenohumeral offset ( LGHO ) , and clinical results were compared for the Copeland ( Biomet Inc , Warsaw , IN , USA ) and the Global C.A.P. ( DePuy Int , Warsaw , IN , USA ) humeral head resurfacing implants ( HHRIs ) .
METHODS	The study randomly allocated 32 patients ( 13 women ) , mean age 63 years ( range , 39-82 years ) , with shoulder osteoarthritis to a Copeland ( n = 14 ) or Global C.A.P. ( n = 18 ) HHRI .
METHODS	Patients were monitored for 2 years with radiostereometry , dual-energy X-ray absorptiometry , Constant Shoulder Score ( CSS ) , and the Western Ontario Osteoarthritis of the Shoulder Index ( WOOS ) .
METHODS	LGHO was measured preoperatively and 6 months postoperatively .
RESULTS	At 2 years , total translation ( TT ) was 0.48 mm ( standard deviation [ SD ] , 0.21 mm ) for the Copeland and 0.82 mm ( SD , 0.46 mm ) for the Global C.A.P. ( P = .06 ) .
RESULTS	Five HHRI were revised , and in the interval before the last follow-up ( revision or 2 years ) , TT of 0.58 mm ( SD , 0.61 mm ) for revised HHRI was higher ( P = .02 ) than TT of 0.22 mm ( SD , 0.17 mm ) in nonrevised HHRI .
RESULTS	A comparison of TT at the last follow-up ( revision or 2 years ) found no difference between the HHRIs ( P = .12 ) .
RESULTS	Periprosthetic BMD decreased initially but increased continuously after 6 months for both HHRIs .
RESULTS	At 2 years , BMD was 48 % higher around the Copeland HHRI ( P = .005 ) .
RESULTS	The mean difference in LGHO was significantly higher for the Copeland than for the Global C.A.P. HHRI ( P = .02 ) .
RESULTS	Clinical results evaluated with CSS and WOOS improved over time for both implant groups ( P < .01 ) , with no differences between the groups .
CONCLUSIONS	Both implants had only little migration and good clinical results .
CONCLUSIONS	Periprosthetic BMD and LGHO both increased for the Copeland HHRI more than for the Global C.A.P HHRI .

###24334921
BACKGROUND	The role of glucagon-like peptide-1 receptor ( GLP-1R ) variants on body weight response after dietary intervention has not been evaluated so far .
OBJECTIVE	Our aim was to evaluate weight loss and adipocytokine levels after two hypocaloric diets with different macronutrient distribution in obese subjects with rs6923761 .
METHODS	A sample of 280 obese subjects was randomized to two hypocaloric diets .
RESULTS	124 patients ( 44.3 % ) had the genotype GG ( wild-type ) and 156 ( 55.7 % ) had another genotype ( mutant ) , i.e. GA ( n = 132 , 47.1 % ) or AA ( n = 24 , 8.6 % ) .
RESULTS	With the type I diet ( low in carbohydrates ) in the wild-type and mutant groups , BMI , weight , fat mass , waist circumference , insulin levels , insulin resistance and triglycerides decreased .
RESULTS	Anthropometric parameters were higher in non-A-allele carriers than A-allele carriers .
RESULTS	With the type II diet ( low in fats ) in all genotypes , BMI , weight , fat mass , waist circumference , insulin levels , total cholesterol and LDL cholesterol decreased .
CONCLUSIONS	Our data showed better anthropometric parameters in obese subjects with the mutant allele ( A ) of the rs6923761 GLP-1R polymorphism .
CONCLUSIONS	A lack of association of this polymorphism with weight loss or biochemical parameters after two different hypocaloric diets was observed .

###24766686
OBJECTIVE	Missing data are a significant problem in clinical trials , particularly for quality of life ( QOL ) , which can not be obtained retrospectively .
OBJECTIVE	The purpose of this study was to evaluate the feasibility of an electronic web-based strategy for QOL data collection in a cooperative group radiation oncology trial setting .
METHODS	Radiation Therapy Oncology Group ( RTOG ) 0828 was a prospective National Cancer Institute cooperative group companion study of RTOG-0415 , a randomized study of conventional versus hypofractionated radiation .
METHODS	Forty-nine English-speaking patients with favorable risk prostate cancer who enrolled on RTOG-0415 consented to using web-based technology for completing QOL .
METHODS	In RTOG-0415 , using paper forms , the 6-month QOL compliance rate was 52 % .
METHODS	The purpose of RTOG-0828 was to test the feasibility of a web-based strategy with the goal of increasing the 6-month QOL completion rate by 25 % ( from 52 % to 77 % ) for a relative improvement of ~ 50 % .
METHODS	The web-based tool used in this study was VisionTree Optimal Care ( VTOC ; VisionTree Software , Inc , San Diego , CA ) , a Health-Insurance-Portability-Accountability-Act secure , online technology that allows real-time tracking and e-mail reminders .
METHODS	The primary endpoint was the 6-month compliance rate for the validated QOL instrument , Expanded Prostate Index Composite .
RESULTS	The QOL completion rate at baseline was 98 % .
RESULTS	Compared with the prior 52 % QOL completion rate at 6 months using paper forms , the QOL web-based completion rate at 6 months was 90 % ( 2-sided P value < .001 ) .
RESULTS	At 12 months , the EPIC completion rate was 82 % ( compared with 36 % using paper forms ) .
CONCLUSIONS	This RTOG study suggests that a web-based strategy to collect QOL appears to be feasible in the cooperative group radiation oncology trial setting and is associated with an increase in the 6-month QOL compliance rate compared with the prior method of using paper forms .
CONCLUSIONS	The RTOG plans to further test this strategy in a head-and-neck cancer trial across all participating RTOG sites .

###25295834
OBJECTIVE	The increase in numbers of patients requiring oral anti-coagulation testing in outpatient clinics has focused attention on alternative flexible systems of anti-coagulation management .
OBJECTIVE	One option is pharmacist led patient self-testing ( PST ) of international normalised ratio ( INR ) levels .
OBJECTIVE	PST has demonstrated improvements in anti-coagulation control , but its cost-effectiveness is inconclusive .
OBJECTIVE	This study reports the first cost-effectiveness evaluation of a randomized controlled trial of an automated direct-to-patient expert system , enabling remote and effective management of patients on oral anti-coagulation therapy .
METHODS	We conducted an economic evaluation alongside a randomised controlled trial investigating a pharmacist led PST method .
METHODS	The primary outcome was to determine the cost effectiveness of PST in comparison with usual care ( management in a hospital based anti-coagulation clinic ) .
METHODS	Long term anti-coagulation patients were recruited to a 6 month cross over study between PST and routine care in an anti-coagulation clinic .
METHODS	Economic evaluation was from the healthcare payer perspective .
CONCLUSIONS	On a per patient basis over a 6 month period , PST resulted in an incremental cost of 59.08 in comparison with routine care .
CONCLUSIONS	Patients achieved a significantly higher time in therapeutic range ( TTR ) during the PST arm in comparison with routine care , ( 72 19.7 % vs. 59 13.5 % ) .
CONCLUSIONS	Overall cost of managing a patient through pharmacist supervised PST for a 6 month period is 226.45 .
CONCLUSIONS	Additional analysis of strategies from a societal perspective indicated that PST was the dominant strategy .
CONCLUSIONS	Pharmacist led patient self-testing is a viable method of management .
CONCLUSIONS	It provides significant increases in anti-coagulation control for a minimal increase in cost .

###25052161
BACKGROUND	Psoriasis causes worldwide concern because of its high-prevalence , as well as its harmful , and incurable characteristics .
BACKGROUND	Topical therapy is a conventional treatment for psoriasis vulgaris .
BACKGROUND	Chinese medicine ( CM ) has been commonly used in an integrative way for psoriasis patients for many years .
BACKGROUND	Some CM therapies have shown therapeutic effects for psoriasis vulgaris ( PV ) , including relieving symptoms and improving quality of life , and may reduce the relapse rate .
BACKGROUND	However , explicit evidence has not yet been obtained .
BACKGROUND	The purpose of the present trial is to examine the efficacy and safety of the YXBCM01 granule , a compound Chinese herbal medicine , with a combination of topical therapy for PV patients .
METHODS	Using an add-on design , the trial is to evaluate whether the YXBCM01 granule combined topical therapy is more effective than topical therapy alone for the treatment of PV .
METHODS	The study design is a double-blind , parallel , randomized controlled trial comparing the YXBCM01 granule ( 5.5 g twice daily ) to a placebo .
METHODS	The duration of treatment is 12weeks .
METHODS	A total of 600 participants will be randomly allocated into two groups , YXBCM01 granule group and placebo group , from 11 general or dermatological hospitals in China .
METHODS	Topical use of calcipotriol betamethasone for the first 4weeks and calcipotriol ointment for the remaining 8weeks will be the same standard therapy for the two groups .
METHODS	Patients will be enrolled if they have a clinical diagnosis of PV , a psoriasis area severe index ( PASI ) of more than 10 or body surface area ( BSA ) of more than 10 % , but PASI of less than 30 and BSA of less than 30 % , are aged between 18 and 65-years-old , and provide signed informed consent .
METHODS	The primary outcome , relapse rate , is based on PASI assessed blindly during the treatment .
METHODS	Secondary outcomes include : ( i ) relapse time interval , ( ii ) time to onset , ( iii ) rebound rate , ( iv ) PASI score , ( v ) cumulative consumption of medicine , ( vi ) the dermatology quality life index ( DLQI ) , and ( vii ) the medical outcomes study ( MOS ) item short form health survey ( SF-36 ) .
METHODS	Analysis will be on intention-to-treat and per-protocol subject analysis principles .
CONCLUSIONS	To address the effectual remission of the YXBCM01 granule for PV , this trial may provide a novel regimen for PV patients if the granule can decrease relapse rate without more adverse effects .
BACKGROUND	Chinese Clinical Trial Registry ( http://cwww.chictr.org ) : ChiCTR-TRC-13003233 , registered 26 May 2013 .

###25234679
OBJECTIVE	This study sought to report the results of a prospective randomized controlled trial comparing paclitaxel-coated balloons ( PCB ) versus drug-eluting stents ( DES ) in long infrapopliteal lesions .
BACKGROUND	DES have an established role in the treatment of short infrapopliteal lesions , whereas there is increasing evidence for the use of PCB in longer below-the-knee lesions .
METHODS	Inclusion criteria were patients with Rutherford classes 3 to 6 and angiographically documented infrapopliteal disease with a minimum lesion length of 70 mm .
METHODS	The primary endpoint was target lesion restenosis > 50 % assessed by digital angiography at 6 months .
METHODS	Secondary endpoints included immediate post-procedure stenosis and target lesion revascularization .
RESULTS	Fifty patients were randomized to undergo infrapopliteal PCB angioplasty ( 25 arteries in 25 limbs ; PCB group ) or primary DES placement ( 30 arteries in 27 limbs ; DES group ) .
RESULTS	Immediate residual post-procedure stenosis was significantly lower in DES ( 9.6 2.2 % vs. 24.8 3.5 % in PCB ; p < 0.0001 ) .
RESULTS	At 6 months , 5 patients died ( 2 in PCB vs. 3 in DES ; p = 1.00 ) and 3 suffered a major amputation ( 1 in PCB vs. 2 in DES ; p = 1.00 ) .
RESULTS	In total , 44 angiograms were evaluable with quantitative vessel analysis .
RESULTS	Binary ( > 50 % ) angiographic restenosis rate was significantly lower in DES ( 7of 25 [ 28 % ] vs. 11 of 19 [ 57.9 % ] in PCB ; p = 0.0457 ) .
RESULTS	There were no significant differences with regard to target lesion revascularization ( 2 of 26 [ 7.7 % ] in DES vs. 3 of 22 [ 13.6 % ] in PCB ; p = 0.65 ) .
RESULTS	Positive vessel wall remodeling was observed in 3 cases in the PCB arm ( 3 of 19 [ ( 15.8 % ) ] vs. 0 of 19 [ 0 % ] in DES ; p = 0.07 ) .
CONCLUSIONS	Compared with PCB in long infrapopliteal lesions , DES are related with significantly lower residual immediate post-procedure stenosis and have shown significantly reduced vessel restenosis at 6 months .
CONCLUSIONS	PCB may produce positive vessel remodeling .
CONCLUSIONS	( Infrapopliteal Drug-Eluting Angioplasty Versus Stenting [ IDEAS-I ] ; NCT01517997 ) .

###25282564
BACKGROUND	Recent studies have suggested that epidermal barrier dysfunction contributes to the development of atopic dermatitis ( AD ) and other allergic diseases .
OBJECTIVE	We performed a prospective , randomized controlled trial to investigate whether protecting the skin barrier with a moisturizer during the neonatal period prevents development of AD and allergic sensitization .
METHODS	An emulsion-type moisturizer was applied daily during the first 32 weeks of life to 59 of 118 neonates at high risk for AD ( based on having a parent or sibling with AD ) who were enrolled in this study .
METHODS	The onset of AD ( eczematous symptoms lasting > 4 weeks ) and eczema ( lasting > 2 weeks ) was assessed by a dermatology specialist on the basis of the modified Hanifin and Rajka criteria .
METHODS	The primary outcome was the cumulative incidence of AD plus eczema ( AD/eczema ) at week 32 of life .
METHODS	A secondary outcome , allergic sensitization , was evaluated based on serum levels of allergen-specific IgE determined by using a high-sensitivity allergen microarray of diamond-like carbon-coated chips .
RESULTS	Approximately 32 % fewer neonates who received the moisturizer had AD/eczema by week 32 than control subjects ( P = .012 , log-rank test ) .
RESULTS	We did not show a statistically significant effect of emollient on allergic sensitization based on the level of IgE antibody against egg white at 0.34 kUA/L CAP-FEIA equivalents .
RESULTS	However , the sensitization rate was significantly higher in infants who had AD/eczema than in those who did not ( odds ratio , 2.86 ; 95 % CI , 1.22-6 .73 ) .
CONCLUSIONS	Daily application of moisturizer during the first 32 weeks of life reduces the risk of AD/eczema in infants .
CONCLUSIONS	Allergic sensitization during this time period is associated with the presence of eczematous skin but not with moisturizer use .

###24441150
OBJECTIVE	The aim of this study was to compare efficacy outcomes of initial treatment with adalimumab + MTX vs adalimumab addition following 26 weeks of MTX monotherapy in Japanese early RA patients naive to MTX with high disease activity .
METHODS	Patients completing the 26-week , randomized , placebo-controlled trial of adalimumab + MTX were eligible to receive 26 weeks of open-label adalimumab + MTX .
METHODS	Patients were assessed for mean change from baseline in the 28-joint DAS with ESR ( DAS28-ESR ) and modified total Sharp score ( mTSS ) , and for the proportions of patients achieving clinical , functional or radiographic remission .
RESULTS	Of 333 patients assessed , 278 ( 137 from the initial adalimumab + MTX and 141 from the initial placebo + MTX groups ) completed the 52-week study .
RESULTS	Significant differences in clinical and functional parameters observed during the 26-week blinded period were not apparent following the addition of open-label adalimumab to MTX .
RESULTS	Open-label adalimumab + MTX slowed radiographic progression through week 52 in both groups , but patients who received adalimumab + MTX throughout the study exhibited less radiographic progression than those who received placebo + MTX during the first 26 weeks ( mean mTSS at week 52 = 2.56 vs 3.30 , P < 0.001 ) .
CONCLUSIONS	Delayed addition of adalimumab in Japanese MTX-naive early RA patients did not impact clinical and functional outcomes at week 52 compared with the earlier addition of adalimumab .
CONCLUSIONS	However , the accrual of significant structural damage during blinded placebo + MTX therapy contributed to the persistence of differences between the treatment strategies , suggesting that Japanese patients at risk for aggressive disease should benefit from the early inclusion of adalimumab + MTX combination therapy .
CONCLUSIONS	Trial registration .
CONCLUSIONS	ClinicalTrials.gov ( http://clinicaltrials.gov/ ) , NCT00870467 .

###24687826
OBJECTIVE	Patient-reported outcomes may help inform treatment choice in advanced/metastatic renal cell carcinoma ( RCC ) , particularly between approved targeted therapies with similar efficacy .
OBJECTIVE	This double-blind cross-over study evaluated patient preference for pazopanib or sunitinib and the influence of health-related quality of life ( HRQoL ) and safety factors on their stated preference .
METHODS	Patients with metastatic RCC were randomly assigned to pazopanib 800 mg per day for 10 weeks , a 2-week washout , and then sunitinib 50 mg per day ( 4 weeks on , 2 weeks off , 4 weeks on ) for 10 weeks , or the reverse sequence .
METHODS	The primary end point , patient preference for a specific treatment , was assessed by questionnaire at the end of the two treatment periods .
METHODS	Other end points and analyses included reasons for preference , physician preference , safety , and HRQoL .
RESULTS	Of 169 randomly assigned patients , 114 met the following prespecified modified intent-to-treat criteria for the primary analysis : exposure to both treatments , no disease progression before cross over , and completion of the preference questionnaire .
RESULTS	Significantly more patients preferred pazopanib ( 70 % ) over sunitinib ( 22 % ) ; 8 % expressed no preference ( P < .001 ) .
RESULTS	All preplanned sensitivity analyses , including the intent-to-treat population , statistically favored pazopanib .
RESULTS	Less fatigue and better overall quality of life were the main reasons for preferring pazopanib , with less diarrhea being the most cited reason for preferring sunitinib .
RESULTS	Physicians also preferred pazopanib ( 61 % ) over sunitinib ( 22 % ) ; 17 % expressed no preference .
RESULTS	Adverse events were consistent with each drug 's known profile .
RESULTS	Pazopanib was superior to sunitinib in HRQoL measures evaluating fatigue , hand/foot soreness , and mouth/throat soreness .
CONCLUSIONS	This innovative cross-over trial demonstrated a significant patient preference for pazopanib over sunitinib , with HRQoL and safety as key influencing factors .

###24292257
BACKGROUND	Only a few , small , monocentric randomized controlled trials ( RCTs ) have compared routine vs. no placement of a nasogastric or nasojejunal tube decompression ( NG/NJT ) in patients undergoing partial distal gastrectomy ( PDG ) for gastric cancer .
BACKGROUND	However , to our knowledge , no multicenter prospective RCT has analyzed the role of decompression after both the Billroth II ( BII ) procedure and Roux-en-Y ( RY ) gastrojejunostomy .
BACKGROUND	The aim of this study was to determine whether NG/NJT prevents the consequences of postoperative ileus after PDG for gastric cancer after both BII reconstruction and RY .
METHODS	Two hundred seventy patients undergoing PDG for gastric cancer were randomly assigned NG/NJT placement ( NG/NJT group ) or not ( no-NG/NJT group ) with either Billroth II gastrojejunostomy or Roux-en-Y gastrojejunostomy .
METHODS	The patients were monitored for postoperative complications , mortality , and postoperative course .
RESULTS	By January 2010 to June 2012 , among 270 patients undergoing PDG for gastric cancer , 134 were randomly assigned to NG/NJT placement ( NG/NJT group ) and 136 to no decompression ( no-NG/NJT group ) .
RESULTS	Time to passage of flatus was significantly shorter in the NG/NJT group than in the no-NG/NJT group , but only after RY reconstruction ( 3.3 1.5 vs. 4.3 1.6 days , P < 0.001 , respectively ) .
RESULTS	Postoperative abdominal distention was significantly lower in the NG/NJT group than in the no-NG/NJT group after both BII and the RY procedure ( P < 0.001 ) .
RESULTS	No significant differences in postoperative mortality or morbidity , especially anastomotic leakage or intra-abdominal sepsis , were observed between the groups .
CONCLUSIONS	Routine placement of an NG/NJT after BII and RY PDG is not necessary in elective surgery for gastric cancer .

###24469906
OBJECTIVE	Once daily doses of 100-400 mg lumiracoxib have been proposed to inhibit local prostaglandin synthesis longer than systemic prostaglandin synthesis due to local accumulation in inflamed , acidic tissue .
OBJECTIVE	Lower , less toxic doses , however , might still achieve the clinical goal and merit further contemplation .
METHODS	In a randomized , double-blind , placebo-controlled , three-way cross-over study , 18 healthy men received , with an interval of 24 h , two oral doses of 50 mg lumiracoxib or for comparison , 90 mg etoricoxib , for which local tissue accumulation has not been claimed as therapeutic component .
METHODS	Systemic and local drug concentrations , assessed by means of subcutaneous in-vivo microdialysis , were related to COX-2 inhibiting effects , quantified as inhibition of prostaglandin ex-vivo production in whole blood as well as local tissue prostaglandin ( PG ) concentrations .
RESULTS	Twenty-four hours after the first dose , only etoricoxib was detectable in plasma and inhibited PGE2 production .
RESULTS	In contrast , after the second dose , systemic PGE2 concentrations were significantly reduced by both coxibs , indicating similar maximum systemic effects of the selected doses .
RESULTS	The local COX-2 inhibition by etoricoxib was most pronounced for PGD2 .
RESULTS	To the contrary , no indication was given of local inhibition of PG production by lumiracoxib at the dose tested .
CONCLUSIONS	Doses of 50 mg lumiracoxib and 90 mg etoricoxib produced similar maximum inhibition of systemic COX-2 function whereas 50 mg lumiracoxib was ineffective in producing local COX-2 inhibition .
CONCLUSIONS	At a 50 mg dosage , lumiracoxib does not provide peripheral effects that outlast its systemic actions in therapies of rheumatic diseases such as osteoarthritis .

###26062180
OBJECTIVE	To observe the acupuncture effect on urinary retention after spinal anesthesia .
METHODS	One hundred and fifty-four patients with spinal anesthesia were randomized into an observation group ( 80 cases ) and a control group ( 74 cases ) .
METHODS	In the observation group , the electroacupuncture was applied to bilateral Fushe ( SP 13 ) and Shuidao ( ST 28 ) ; 2 Hz/50 Hz , retaining for 30 min .
METHODS	One treatment was required .
METHODS	In the control group , no any intervention was applied after operation .
METHODS	The incidence of the postoperative urinary retention , the time of the first automatic micturition since 30 min after spinal anesthesia , the volume of the first micturition , the postoperative urine condition , the lower abdominal distention , incomplete urination and the others were observed .
RESULTS	The incidence of urinary retention in the observation group was lower than that in the control group ; the first automatic micturition in 30 min after spinal anesthesia was earlier than that in the control group ; the comfortable urination rate was higher than that in the control group ; the incidence of incomplete urination and lower abdominal distention were lower than those in the control group .
RESULTS	The differences were significant in comparison of the two groups ( all P < 0.05 ) .
CONCLUSIONS	Acupuncture apparently shortens the time of first automatic micturition after spinal anesthesia and promotes the recovery of bladder urinary reflection .
CONCLUSIONS	This therapy acts on promoting urination and reducing postoperative urinary retention .

###25098313
BACKGROUND	Chronic Obstructive Pulmonary Disease ( COPD ) is a growing worldwide problem that imposes a great burden on the daily life of patients .
BACKGROUND	Since there is no cure , the goal of treating COPD is to maintain or improve quality of life .
BACKGROUND	We have developed a new tool , the Assessment of Burden of COPD ( ABC ) tool , to assess and visualize the integrated health status of patients with COPD , and to provide patients and healthcare providers with a treatment algorithm .
BACKGROUND	This tool may be used during consultations to monitor the burden of COPD and to adjust treatment if necessary .
BACKGROUND	The aim of the current study is to analyse the effectiveness of the ABC tool compared with usual care on health related quality of life among COPD patients over a period of 18 months .
METHODS	A cluster randomised controlled trial will be conducted in COPD patients in both primary and secondary care throughout the Netherlands .
METHODS	An intervention group , receiving care based on the ABC tool , will be compared with a control group receiving usual care .
METHODS	The primary outcome will be the change in score on a disease-specific-quality-of-life questionnaire , the Saint George Respiratory Questionnaire .
METHODS	Secondary outcomes will be a different questionnaire ( the COPD Assessment Test ) , lung function and number of exacerbations .
METHODS	During the 18 months follow-up , seven measurements will be conducted , including a baseline and final measurement .
METHODS	Patients will receive questionnaires to be completed at home .
METHODS	Additional data , such as number of exacerbations , will be recorded by the patients ' healthcare providers .
METHODS	A total of 360 patients will be recruited by 40 general practitioners and 20 pulmonologists .
METHODS	Additionally , a process evaluation will be performed among patients and healthcare providers .
CONCLUSIONS	The new ABC tool complies with the 2014 Global Initiative for Chronic Obstructive Lung Disease guidelines , which describe the necessity to classify patients on both their airway obstruction and a comprehensive symptom assessment .
CONCLUSIONS	It has been developed to classify patients , but also to provide visual insight into the burden of COPD and to provide treatment advice .
BACKGROUND	Netherlands Trial Register , NTR3788 .

###24586490
BACKGROUND	The aim of this study was to assess the effects of darapladib , a selective oral investigational lipoprotein-associated phospholipase A2 inhibitor , on both plasma and plaque lipoprotein-associated phospholipase A2 activity .
METHODS	Patients undergoing elective carotid endarterectomy were randomized to darapladib 40 mg ( n = 34 ) , 80 mg ( n = 34 ) , or placebo ( n = 34 ) for 14 days , followed by carotid endarterectomy 24 hours after the last dose of study medication .
RESULTS	Darapladib 40 mg and 80 mg reduced plasma lipoprotein-associated phospholipase A2 activity by 52 % and 81 % , respectively , versus placebo ( both P < 0.001 ) .
RESULTS	Significant reductions in plaque lipoprotein-associated phospholipase A2 activity were also observed compared with placebo ( P < 0.0001 ) , which equated to a 52 % and 80 % decrease compared with placebo .
RESULTS	No significant differences were observed between groups in plaque lysophosphatidylcholine content or other biomarkers , although a dose-dependent decrease in plaque matrix metalloproteinase-9 mRNA expression was observed with darapladib 80 mg ( P = 0.053 vs placebo ) .
RESULTS	In a post-hoc analysis , plaque caspase-3 ( P < 0.001 ) and caspase-8 ( P < 0.05 ) activity were found to be significantly lower in the darapladib 80-mg group versus placebo .
RESULTS	No major safety concerns were identified in the study .
CONCLUSIONS	Short-term treatment ( 14 4 days ) with darapladib produced a robust , dose-dependent reduction in plasma lipoprotein-associated phospholipase A2 activity .
CONCLUSIONS	More importantly , darapladib demonstrated placebo-corrected reductions in carotid plaque lipoprotein-associated phospholipase A2 activity of similar magnitude .
CONCLUSIONS	Darapladib was generally well tolerated and no safety concerns were identified .
CONCLUSIONS	Additional studies of longer duration are needed to explore whether these pharmacodynamic effects are associated with improved clinical outcomes , as might be hypothesized .

###24859205
OBJECTIVE	The CpG island methylator phenotype ( CIMP ) , defined by a high frequency of aberrantly methylated genes , is a characteristic of a subclass of colon tumors with distinct clinical and molecular features .
OBJECTIVE	Cohort studies have produced conflicting results on responses of CIMP-positive tumors to chemotherapy .
OBJECTIVE	We assessed the association between tumor CIMP status and survival of patients receiving adjuvant fluorouracil and leucovorin alone or with irinotecan ( IFL ) .
METHODS	We analyzed data from patients with stage III colon adenocarcinoma randomly assigned to groups given fluorouracil and leucovorin or IFL after surgery , from April 1999 through April 2001 .
METHODS	The primary end point of the trial was overall survival and the secondary end point was disease-free survival .
METHODS	DNA isolated from available tumor samples ( n = 615 ) was used to determine CIMP status based on methylation patterns at the CACNA1G , IGF2 , NEUROG1 , RUNX3 , and SOCS1 loci .
METHODS	The effects of CIMP on survival were modeled using Kaplan-Meier and Cox proportional hazards ; interactions with treatment and BRAF , KRAS , and mismatch repair ( MMR ) status were also investigated .
RESULTS	Of the tumor samples characterized for CIMP status , 145 were CIMP positive ( 23 % ) .
RESULTS	Patients with CIMP-positive tumors had shorter overall survival times than patients with CIMP-negative tumors ( hazard ratio = 1.36 ; 95 % confidence interval : 1.01-1 .84 ) .
RESULTS	Treatment with IFLshowed a trend toward increased overall survival for patients with CIMP-positive tumors , compared with treatment with fluorouracil and leucovorin ( hazard ratio = 0.62 ; 95 % CI : 0.37-1 .05 ; P = .07 ) , but not for patients with CIMP-negative tumors ( hazard ratio = 1.38 ; 95 % CI : 1.00-1 .89 ; P = .049 ) .
RESULTS	In a 3-way interaction analysis , patients with CIMP-positive , MMR-intact tumors benefited most from the addition of irinotecan to fluorouracil and leucovorin therapy ( for the interaction , P = .01 ) .
RESULTS	CIMP was more strongly associated withresponse to IFL than MMR status .
RESULTS	Results for disease-free survival times were comparable among all analyses .
CONCLUSIONS	Patients with stage III , CIMP-positive , MMR-intact colon tumors have longer survival times when irinotecan is added to combination therapy with fluorouracil and leucovorin .

###24754555
OBJECTIVE	We assessed the effectiveness of Circle of Life ( COL ) , an HIV-preventive intervention developed specifically for American Indian and Alaska Native ( AI/AN ) middle school youths .
METHODS	By partnering with a tribal community , we conducted a longitudinal wait-listed group randomized trial with 635 seventh and eighth graders in 13 schools of a Northern Plains tribe .
METHODS	We surveyed participants at baseline , 3 months , and 12 months from 2006 to 2007 .
RESULTS	COL was found to increase HIV knowledge in the short term , but had no effect on sexual activity compared with those who did not receive it .
RESULTS	However , COL was found to be effective for delaying the onset of sexual activity , with the greatest reduction in risk occurring for those receiving COL at early ages .
CONCLUSIONS	Community partnership was key to successful project design , implementation , and analysis .
CONCLUSIONS	The project confirmed the importance of the timing of interventions in early adolescence .
CONCLUSIONS	COL may be a key resource for reducing sexual risk among AI/AN youths .

###24768112
BACKGROUND	Patients with radioactive iodine ( ( 131 ) I ) - refractory locally advanced or metastatic differentiated thyroid cancer have a poor prognosis because of the absence of effective treatment options .
BACKGROUND	In this study , we assessed the efficacy and safety of orally administered sorafenib in the treatment of patients with this type of cancer .
METHODS	In this multicentre , randomised , double-blind , placebo-controlled , phase 3 trial ( DECISION ) , we investigated sorafenib ( 400 mg orally twice daily ) in patients with radioactive iodine-refractory locally advanced or metastatic differentiated thyroid cancer that had progressed within the past 14 months .
METHODS	Adult patients ( 18 years of age ) with this type of cancer were enrolled from 77 centres in 18 countries .
METHODS	To be eligible for inclusion , participants had to have at least one measurable lesion by CT or MRI according to Response Evaluation Criteria In Solid Tumors ( RECIST ) ; Eastern Cooperative Oncology Group performance status 0-2 ; adequate bone marrow , liver , and renal function ; and serum thyroid-stimulating hormone concentration lower than 05 mIU/L .
METHODS	An interactive voice response system was used to randomly allocate participants in a 1:1 ratio to either sorafenib or matching placebo .
METHODS	Patients , investigators , and the study sponsor were masked to treatment assignment .
METHODS	The primary endpoint was progression-free survival , assessed every 8 weeks by central independent review .
METHODS	Analysis was by intention to treat .
METHODS	Patients in the placebo group could cross over to open-label sorafenib upon disease progression .
METHODS	Archival tumour tissue was examined for BRAF and RAS mutations , and serum thyroglobulin was measured at baseline and at each visit .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00984282 , and with the EU Clinical Trials Register , number EudraCT 2009-012007-25 .
RESULTS	Patients were randomly allocated on a 1:1 basis to sorafenib or placebo .
RESULTS	The intention-to-treat population comprised 417 patients ( 207 in the sorafenib group and 210 in the placebo group ) and the safety population was 416 patients ( 207 in the sorafenib group and 209 in the placebo group ) .
RESULTS	Median progression-free survival was significantly longer in the sorafenib group ( 108 months ) than in the placebo group ( 58 months ; hazard ratio [ HR ] 059 , 95 % CI 045-076 ; p < 00001 ) .
RESULTS	Progression-free survival improved in all prespecified clinical and genetic biomarker subgroups , irrespective of mutation status .
RESULTS	Adverse events occurred in 204 of 207 ( 986 % ) patients receiving sorafenib during the double-blind period and in 183 of 209 ( 876 % ) patients receiving placebo .
RESULTS	Most adverse events were grade 1 or 2 .
RESULTS	The most frequent treatment-emergent adverse events in the sorafenib group were hand-foot skin reaction ( 763 % ) , diarrhoea ( 686 % ) , alopecia ( 671 % ) , and rash or desquamation ( 502 % ) .
CONCLUSIONS	Sorafenib significantly improved progression-free survival compared with placebo in patients with progressive radioactive iodine-refractory differentiated thyroid cancer .
CONCLUSIONS	Adverse events were consistent with the known safety profile of sorafenib .
CONCLUSIONS	These results suggest that sorafenib is a new treatment option for patients with progressive radioactive iodine-refractory differentiated thyroid cancer .
BACKGROUND	Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals ( an Amgen subsidiary ) .

###25904733
BACKGROUND	Cardiometabolic risk is the risk of cardiovascular disease ( CVD ) , diabetes , or stroke , which are leading causes of mortality and morbidity worldwide .
OBJECTIVE	The objective of this study was to determine the potential of low-calorie cranberry juice ( LCCJ ) to lower cardiometabolic risk .
METHODS	A double-blind , placebo-controlled , parallel-arm study was conducted with controlled diets .
METHODS	Thirty women and 26 men ( mean baseline characteristics : 50 y ; weight , 79 kg ; body mass index , 28 kg/m ( 2 ) ) completed an 8-wk intervention with LCCJ or a flavor/color/energy-matched placebo beverage .
METHODS	Twice daily volunteers consumed 240 mL of LCCJ or the placebo beverage , containing 173 or 62 mg of phenolic compounds and 6.5 or 7.5 g of total sugar per 240-mL serving , respectively .
RESULTS	Fasting serum triglycerides ( TGs ) were lower after consuming LCCJ and demonstrated a treatment baseline interaction such that the participants with higher baseline TG concentrations were more likely to experience a larger treatment effect ( 1.15 0.04 mmol/L vs. 1.25 0.04 mmol/L , respectively ; P = 0.027 ) .
RESULTS	Serum C-reactive protein ( CRP ) was lower for individuals consuming LCCJ than for individuals consuming the placebo beverage [ ln transformed values of 0.522 0.115 ln ( mg/L ) vs. 0.997 0.120 ln ( mg/L ) , P = 0.0054 , respectively , and equivalent to 1.69 mg/L vs. 2.71 mg/L back-transformed ] .
RESULTS	LCCJ lowered diastolic blood pressure ( BP ) compared with the placebo beverage ( 69.2 0.8 mm Hg for LCCJ vs. 71.6 0.8 mm Hg for placebo ; P = 0.048 ) .
RESULTS	Fasting plasma glucose was lower ( P = 0.03 ) in the LCCJ group ( 5.32 0.03 mmol/L ) than in the placebo group ( 5.42 0.03 mmol/L ) , and LCCJ had a beneficial effect on homeostasis model assessment of insulin resistance for participants with high baseline values ( P = 0.035 ) .
CONCLUSIONS	LCCJ can improve several risk factors of CVD in adults , including circulating TGs , CRP , and glucose , insulin resistance , and diastolic BP .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01295684 .

###24447651
OBJECTIVE	To assess the impact of sugammadex on activated partial thromboplastin time ( APTT ) and international normalized ratio for prothrombin time ( PT ( INR ) ) in healthy subjects and characterize the concentration-dependency of sugammadex effects on APTT and prothrombin time ( PT ) in normal human plasma in vitro .
METHODS	Eight healthy subjects ( 18 - 45 years of age ) were administered intravenous doses of 4 mg/kg sugammadex , 16 mg/kg sugammadex , or placebo in a randomized , placebo-controlled , three period cross-over trial .
METHODS	The primary endpoint was area under the curve from 2 to 60 minutes post-dose ( AUC2-60min ) for APTT and PT ( INR ) .
METHODS	In vitro , the effects of sugammadex on APTT and PT were assessed in pooled normal human citrate plasma .
RESULTS	In subjects dosed with 4 and 16 mg/kg sugammadex , geometric mean ratios ( treated vs. placebo ) for AUC2-60min were 1.085 ( 95 % confidence interval , 0.888 - 1.325 ) and 1.019 ( 0.868 - 1.195 ) , respectively , for APTT , and 1.047 ( 0.904 - 1.213 ) and 1.096 ( 0.953 - 1.261 ) , respectively , for PT ( INR ) .
RESULTS	At individual timepoints , mean APTT and PT ( INR ) increased by up to 22 % after 16 mg/kg sugammadex compared with placebo .
RESULTS	All such increases occurred within 30 minutes post-dose .
RESULTS	Sugammadex was generally well tolerated .
RESULTS	In the in vitro experiments , addition of sugammadex to plasma resulted in limited , concentration dependent increases in both APTT and PT .
RESULTS	At 200 g/mL ( the mean maximum concentration reached therapeutically ) , the relative increases were 29 % and 19 % , respectively .
CONCLUSIONS	Administration of sugammadex is associated with a dose-related , limited and transient prolongation of APTT and PT ( INR ) that is unlikely to be of clinical relevance .

###25079862
OBJECTIVE	Besides diabetic patients , glycated hemoglobin ( HbA1c ) levels have been reported to predict mortality in non-diabetics patients .
OBJECTIVE	However , the importance of HbA1c levels in non-diabetic hemodialysis patients still remains unknown .
OBJECTIVE	Thus , we aimed to prospectively investigate the impact of HbA1c on all-cause and cardiovascular mortality in a large group of prevalent non-diabetic hemodialysis patients .
METHODS	HbA1c was measured quarterly in 489 non-diabetic prevalent hemodialysis patients .
METHODS	Overall and cardiovascular mortality were evaluated over a 3 year follow-up .
RESULTS	Mean HbA1c level was 4.88 0.46 % ( 3.5 - 6.9 % ) .
RESULTS	During the 28.3 10.6 months follow-up period , 67 patients ( 13.7 % ) died ; 31 from cardiovascular causes .
RESULTS	In Kaplan-Meier analysis , patients in the lowest ( < 4.69 % ) and highest HbA1c ( > 5.04 % ) tertiles had poorer overall survival compared to the middle HbA1c tertile ( p < 0.001 ) .
RESULTS	Adjusted Cox-regression analysis revealed that the highest HbA1c tertile was associated with both overall ( HR = 3.60 , 95 % CI 1.57 - 8.27 , p = 0.002 ) and cardiovascular ( HR = 6.66 , 95 % CI 1.51 - 29.4 ; p = 0.01 ) mortality .
RESULTS	Also , low HbA1c levels tended to be associated with overall mortality ( HR = 2.26 , 95 % CI 0.96 - 5.29 , p = 0.06 ) .
CONCLUSIONS	Upper normal HbA1c levels are independently associated with cardiovascular and overall mortality in non-diabetic hemodialysis patients , whereas lower HbA1c levels are not .

###24714415
BACKGROUND	Indoxyl sulfate ( IS ) suppresses erythropoietin ( EPO ) activity and exerts renal damage .
BACKGROUND	The oral adsorbent AST-120 reduces IS load and has antioxidant and renoprotective properties ; however , its roles in the treatment of anemia remain unclear in chronic kidney disease ( CKD ) patients .
METHODS	Fifty-one Stage 5 predialysis CKD patients with hemoglobin < 10 g/dL were randomly assigned to receive two period treatments with AST-120 plus once-monthly administration of continuous EPO receptor activator ( CERA , A ) and CERA alone ( B ) , with a 4-week washout period in between .
METHODS	Mean changes of serum creatinine , estimated glomerular filtration rate ( eGFR ) and hemoglobin levels from the baseline were compared between two treatments .
RESULTS	The baseline and postintervention mean creatinine levels were 5.48 and 5.36 mg/dL in the Treatment A , and 5.14 mg/dL and 5.61 g/dL in the Treatment B group , respectively ( treatment effect P = 0.025 , period effect P = 0.467 , carryover effect P = 0.384 ) .
RESULTS	The baseline and postintervention mean hemoglobin levels were 9.27 and 10.47 g/dL in the Treatment A , and 9.63 g/dL and 9.54 g/dL in the Treatment B group , respectively ( treatment effect P = 0.039 , period effect P = 0.001 , carryover effect P = 0.060 ) .
RESULTS	Use of AST-120 significantly reduced IS and p-cresyl sulfate ( PCS ) levels .
RESULTS	Hierarchical regression showed that eGFR was an independent predictor for hemoglobin after adjustment of serum free IS and PCS levels ( B = 0.049 , P = 0.005 ) .
CONCLUSIONS	Use of adjuvant AST-120 may improve renal function and hemoglobin levels than use of CERA alone in late-stage CKD patients .
CONCLUSIONS	The change of eGFR might play an intermediate role between serum IS/PCS and improve hemoglobin levels .
CONCLUSIONS	The finding offered insight into novel therapeutic strategies of anemia for late-stage CKD patients .

###24605986
OBJECTIVE	Two studies examined the hypothesis that the presence vs. absence of holiday food cues leads dieters to bolster self-regulatory resources and reduce consumption of a snack food .
OBJECTIVE	Study 1 evaluated snack-food consumption on a holiday vs. a non-holiday and in Study 2 , the proposed underlying mechanism -- the bolstering of self-regulatory resources when facing holiday-related cues -- was explored .
METHODS	Study 1 followed a quasi-experimental design in which participants ( N = 152 ) consumed candies either on a holiday or a non-holiday .
METHODS	Dieting behaviour was measured and the main outcome measure was consumption quantity .
METHODS	In Study 2 , a true experiment , participants ( N = 110 ) read primes associated with holiday eating , holiday history or a neutral topic .
METHODS	Self-regulatory bolstering was assessed as the main outcome measure .
RESULTS	Study 1 showed that dieters consume more of a food item on an ordinary day relative to a holiday ; the consumption patterns of non-dieters did not vary based on holiday cues .
RESULTS	Study 2 demonstrated that dieters , but not non-dieters , bolster self-regulatory resources to a greater extent in the presence vs. absence of a holiday food cue .
CONCLUSIONS	Dieters are better equipped to defend their diet-related goals when facing strong holiday-related temptations than weaker , everyday temptations .

###26027102
OBJECTIVE	To investigate the pathogenesis of globozoospermia , fertilization ability of round-headed sperm , and the application value of assisted oocyte activation in intracytoplasmic sperm injection ( ICSI ) for the wives of glohozoospermia men .
METHODS	We collected oocytes from the wives of 2 globozoospermia patients and randomly divided them into two groups after ICSI to receive calcium ionophore A23187-activation and conventional treatment , respectively .
METHODS	We reviewed the relevant literature published at home and abroad , and discussed the etiology of globozoospermia , fertilization ability of round-headed sperm , and treatment options for this disease .
RESULTS	Quality embryos were obtained in the A23187-activation group while no fertilized oocytes , oocyte cleavage , quality embryos , or blastular formation were found in the conventional treatment group .
RESULTS	Both women achieved pregnancy and gave birth to healthy neonates after transfer of the quality embryos from the A23187-activation group .
CONCLUSIONS	Calcium ionophore A23187 can be applied to ICSI for the wives of globozoospermia men and bring about desirable clinical outcomes .
CONCLUSIONS	Meanwhile , attention should be paid to its safety .

###24385115
BACKGROUND	A fixed-dose combination of clindamycin phosphate 1.2 % and tretinoin 0.025 % gel ( VELTIN ( clindamycin phosphate and tretinoin ) 1.2 % / 0.025 % Gel [ VELTIN ] ) ( clindamycin/tretinoin gel ) is currently available for the once-daily topical treatment of acne .
OBJECTIVE	Two-phase I studies were conducted to evaluate the phototoxic and photoallergic potential of clindamycin/tretinoin gel .
METHODS	Study 1 ( phototoxic ) ( n = 37 ) and Study 2 ( photoallergic ) ( n = 58 ) were single-center , evaluator-blinded , randomized , vehicle-controlled , phase 1 studies conducted in healthy volunteers .
METHODS	In Study 1 , clindamycin/tretinoin gel patches , vehicle gel patches and blank patches ( no gel ) were applied concurrently for 24 hours to nave sites .
METHODS	After patch removal , sites were irradiated with 16 joules/cm2 of ultraviolet A light ( UVA ) then 0.75 minimal erythema dose ( MED ) of UVA/ultraviolet B light ( UVB ) , the same irradiation protocol followed by 15 joules/cm2 of visible light ( VIS ) , or served as non-irradiated controls .
METHODS	Study 2 examined the effect of repeated drug exposure and involved an induction period ( 6 repeat phases at the same body sites during which clindamycin/tretinoin gel and vehicle gel patches were applied for 24 hours , removed and sites irradiated with UVB + / - VIS ) , followed by a rest period ( 10 to 17 days ) , then a challenge period that used the protocol described for Study 1 .
METHODS	In both studies , inflammatory responses and other cutaneous effects were evaluated at 1 , 24 , 48 , and 72 hours after patch removal .
RESULTS	No subject experienced any adverse events in Study 1 ( phototoxic ) .
RESULTS	One subject in Study 2 ( photoallergic ) experienced AEs ( diffuse erythema ; mild application site irritation at one each of UV/VIS-irradiated clindamycin/tretinoin gel and vehicle gel patch sites ) considered definitely related to study product that resulted in discontinuation from the study .
RESULTS	Data from Study 1 and the challenge phase from Study 2 showed most subjects had no visible inflammatory reaction to clindamycin/tretinoin gel after irradiation .
CONCLUSIONS	Clindamycin/tretinoin gel has a favorable safety profile following UV/visible irradiation and a low potential for phototoxicity and photoallergenicity .

###24439682
OBJECTIVE	To assess changes in health related quality of life after a cognitive behavioural program for patients diagnosed with abridged somatization disorder in primary care .
METHODS	A multicentre , randomized , parallel group , controlled trial was designed .
METHODS	168 patients were recruited from 29 primary health care centres in Spain and were randomly assigned to one of the three study arms : treatment as usual improved with Smith 's norms , individual cognitive behavioural treatment , and group cognitive behavioural treatment .
METHODS	Health-related quality of life was assessed using SF-36 Health Survey .
RESULTS	Individual cognitive behavioural treatment achieves greater changes in health related quality of life than group cognitive behavioural therapy and treatment as usual .
RESULTS	Improvement in health related quality of life was fully observed at 12 month , and partially at 6 months .
RESULTS	The modality of intervention interacts with time in all dimensions except for Physical functioning and Vitality .
RESULTS	Patients who received individual cognitive behavioural therapy treatment had better scores in Physical and Mental health summary measures at 12 month follow-up .
CONCLUSIONS	Individual cognitive behavioural treatment is the most effective way to improve health related quality of life in abridged somatization disorder patients , and its effects are sustained over time .
CONCLUSIONS	Also , regardless of the type of intervention , physical functioning improves compared with treatment as usual .

###25367235
OBJECTIVE	Ventricular fibrillation is common after aortic declamping in patients undergoing open heart surgery .
OBJECTIVE	This situation has a negative impact on morbidity and mortality .
OBJECTIVE	The aim of this prospective study was to compare the effect of administering lidocaine versus amiodarone before aortic declamping during elective coronary bypass grafting , paying close attention to when the initial effect of amiodarone sets in .
METHODS	In this double blind , prospective , randomized , controlled study , 86 patients who were candidates for elective coronary artery bypass grafting were recruited into three groups : group lidocaine ( group L , n = 29 ) ; group amiodarone ( group A , n = 27 ) ; and group placebo ( group P , n = 30 ) .
METHODS	Group L patients received 1.5 mg/kg of lidocaine 2 minutes before aortic declamping and group A patients received 300 mg of amiodarone intravenously 15 minutes before release of the aortic cross clamp .
METHODS	The primary endpoints were the incidence of ventricular fibrillation and the number of shocks required to terminate ventricular fibrillation .
RESULTS	The frequency of ventricular fibrillation occurrence was significantly higher in group P ( 70 % ) when compared with group A ( 37 % ) and group L ( 38 % ) ( P = .017 ) .
RESULTS	There was no statistically significant difference between the amiodarone and the lidocaine groups regarding ventricular fibrillation .
RESULTS	However , when ventricular fibrillation occurred , the percentage of patients requiring electrical defibrillation was significantly higher in both group L and group P when compared with group A ( P = .023 ) .
CONCLUSIONS	We suggest that during coronary arterial bypass surgery , administration of an amiodarone regime before release of the aortic cross clamp , paying particular attention to the start of the initial effect of amiodarone , is no more effective than lidocaine for prevention from arrhythmia ; however , amiodarone reduces the need for electrical defibrillation .

###24323035
OBJECTIVE	We evaluated angiogenesis-targeted sunitinib therapy in a randomized , double-blind trial of metastatic castration-resistant prostate cancer ( mCRPC ) .
METHODS	Men with progressive mCRPC after docetaxel-based chemotherapy were randomly assigned 2:1 to receive sunitinib 37.5 mg/d continuously or placebo .
METHODS	Patients also received oral prednisone 5 mg twice daily .
METHODS	The primary end point was overall survival ( OS ) ; secondary end points included progression-free survival ( PFS ) .
METHODS	Two interim analyses were planned .
RESULTS	Overall , 873 patients were randomly assigned to receive sunitinib ( n = 584 ) or placebo ( n = 289 ) .
RESULTS	The independent data monitoring committee stopped the study for futility after the second interim analysis .
RESULTS	After a median overall follow-up of 8.7 months , median OS was 13.1 months and 11.8 months for sunitinib and placebo , respectively ( hazard ratio [ HR ] , 0.914 ; 95 % CI , 0.762 to 1.097 ; stratified log-rank test , P = .168 ) .
RESULTS	PFS was significantly improved in the sunitinib arm ( median 5.6 v 4.1 months ; HR , 0.725 ; 95 % CI , 0.591 to 0.890 ; stratified log-rank test , P < .001 ) .
RESULTS	Toxicity and rates of discontinuations because of adverse events ( AEs ; 27 % v 7 % ) were greater with sunitinib than placebo .
RESULTS	The most common treatment-related grade 3/4 AEs were fatigue ( 9 % v 1 % ) , asthenia ( 8 % v 2 % ) , and hand-foot syndrome ( 7 % v 0 % ) .
RESULTS	Frequent treatment-emergent grade 3/4 hematologic abnormalities were lymphopenia ( 20 % v 11 % ) , anemia ( 9 % v 8 % ) , and neutropenia ( 6 % v < 1 % ) .
CONCLUSIONS	The addition of sunitinib to prednisone did not improve OS compared with placebo in docetaxel-refractory mCRPC .
CONCLUSIONS	The role of antiangiogenic therapy in mCRPC remains investigational .

###24678939
BACKGROUND	Prior unblinded studies have suggested that catheter-based renal-artery denervation reduces blood pressure in patients with resistant hypertension .
METHODS	We designed a prospective , single-blind , randomized , sham-controlled trial .
METHODS	Patients with severe resistant hypertension were randomly assigned in a 2:1 ratio to undergo renal denervation or a sham procedure .
METHODS	Before randomization , patients were receiving a stable antihypertensive regimen involving maximally tolerated doses of at least three drugs , including a diuretic .
METHODS	The primary efficacy end point was the change in office systolic blood pressure at 6 months ; a secondary efficacy end point was the change in mean 24-hour ambulatory systolic blood pressure .
METHODS	The primary safety end point was a composite of death , end-stage renal disease , embolic events resulting in end-organ damage , renovascular complications , or hypertensive crisis at 1 month or new renal-artery stenosis of more than 70 % at 6 months .
RESULTS	A total of 535 patients underwent randomization .
RESULTS	The mean ( SD ) change in systolic blood pressure at 6 months was -14.1323.93 mm Hg in the denervation group as compared with -11.7425.94 mm Hg in the sham-procedure group ( P < 0.001 for both comparisons of the change from baseline ) , for a difference of -2.39 mm Hg ( 95 % confidence interval [ CI ] , -6.89 to 2.12 ; P = 0.26 for superiority with a margin of 5 mm Hg ) .
RESULTS	The change in 24-hour ambulatory systolic blood pressure was -6.7515.11 mm Hg in the denervation group and -4.7917.25 mm Hg in the sham-procedure group , for a difference of -1.96 mm Hg ( 95 % CI , -4.97 to 1.06 ; P = 0.98 for superiority with a margin of 2 mm Hg ) .
RESULTS	There were no significant differences in safety between the two groups .
CONCLUSIONS	This blinded trial did not show a significant reduction of systolic blood pressure in patients with resistant hypertension 6 months after renal-artery denervation as compared with a sham control .
CONCLUSIONS	( Funded by Medtronic ; SYMPLICITY HTN-3 ClinicalTrials.gov number , NCT01418261 . )

###24679062
BACKGROUND	There is substantial variability in the perioperative administration of aspirin in patients undergoing noncardiac surgery , both among patients who are already on an aspirin regimen and among those who are not .
METHODS	Using a 2-by-2 factorial trial design , we randomly assigned 10,010 patients who were preparing to undergo noncardiac surgery and were at risk for vascular complications to receive aspirin or placebo and clonidine or placebo .
METHODS	The results of the aspirin trial are reported here .
METHODS	The patients were stratified according to whether they had not been taking aspirin before the study ( initiation stratum , with 5628 patients ) or they were already on an aspirin regimen ( continuation stratum , with 4382 patients ) .
METHODS	Patients started taking aspirin ( at a dose of 200 mg ) or placebo just before surgery and continued it daily ( at a dose of 100 mg ) for 30 days in the initiation stratum and for 7 days in the continuation stratum , after which patients resumed their regular aspirin regimen .
METHODS	The primary outcome was a composite of death or nonfatal myocardial infarction at 30 days .
RESULTS	The primary outcome occurred in 351 of 4998 patients ( 7.0 % ) in the aspirin group and in 355 of 5012 patients ( 7.1 % ) in the placebo group ( hazard ratio in the aspirin group , 0.99 ; 95 % confidence interval [ CI ] , 0.86 to 1.15 ; P = 0.92 ) .
RESULTS	Major bleeding was more common in the aspirin group than in the placebo group ( 230 patients [ 4.6 % ] vs. 188 patients [ 3.8 % ] ; hazard ratio , 1.23 ; 95 % CI , 1.01 , to 1.49 ; P = 0.04 ) .
RESULTS	The primary and secondary outcome results were similar in the two aspirin strata .
CONCLUSIONS	Administration of aspirin before surgery and throughout the early postsurgical period had no significant effect on the rate of a composite of death or nonfatal myocardial infarction but increased the risk of major bleeding .
CONCLUSIONS	( Funded by the Canadian Institutes of Health Research and others ; POISE-2 ClinicalTrials.gov number , NCT01082874 . )

###24787495
BACKGROUND	There is a lack of appetite studies in free-living subjects supplying the habitual diet with either sucrose or artificially sweetened beverages and foods .
BACKGROUND	Furthermore , the focus of artificial sweeteners has only been on the energy intake ( EI ) side of the energy-balance equation .
BACKGROUND	The data are from a subgroup from a 10-wk study , which was previously published .
OBJECTIVE	The objective was to investigate changes in EI and energy expenditure ( EE ) as possible reasons for the changes in body weight during 10 wk of supplementation of either sucrose or artificial sweeteners in overweight subjects .
METHODS	Supplements of sucrose-sweetened beverages and foods ( 2 g/kg body weight ; n = 12 ) or similar amounts containing artificial sweeteners ( n = 10 ) were given single-blind in a 10-wk parallel design .
METHODS	Beverages accounted for 80 % and solid foods for 20 % by weight of the supplements .
METHODS	The rest of the diet was free choice .
METHODS	Indirect 24-h whole-body calorimetry was performed at weeks 0 and 10 .
METHODS	At week 0 the diet was a weight-maintaining standardized diet .
METHODS	At week 10 the diet consisted of the supplements and ad libitum choice of foods .
METHODS	Visual analog scales were used to record appetite .
RESULTS	Body weight increased in the sucrose group and decreased in the sweetener group during the intervention .
RESULTS	The sucrose group had a 3.3-MJ higher EI but felt less full and had higher ratings of prospective food consumption than did the sweetener group at week 10 .
RESULTS	Basal metabolic rate was increased in the sucrose group , whereas 24-h EE was increased in both groups at week 10 .
RESULTS	Energy balance in the sucrose group was more positive than in the sweetener group at the stay at week 10 .
CONCLUSIONS	The changes in body weight in the 2 groups during the 10-wk intervention seem to be attributable to changes in EI rather than to changes in EE .

###24836438
METHODS	Cluster randomised crossover trial with seven wards randomly allocated to intervention or control arm .
METHODS	Medical and surgical wards of a university hospital with active MRSA control programme .
METHODS	All patients hospitalized > 48 h in study wards and screened for MRSA on admission and discharge Intervention : Rapid PCR-based screening test for MRSA compared with control screening test by enrichment culture using chromogenic agar .
OBJECTIVE	We determined the benefit of PCR-detection versus culture-based detection of MRSA colonisation upon patient admission on early implementation of isolation precautions and reduction of hospital transmission of MRSA .
RESULTS	Cumulative rate of MRSA hospital acquisition of in patients screened negative on admission .
METHODS	The sequential order of inclusion of study wards in each arm was randomised by assigning a number to each ward and using a computer generated list of random numbers .
RESULTS	Of 3704 eligible patients , 67.8 % were evaluable for the study .
RESULTS	Compared with culture , PCR-screening reduced the median test reporting time from admission from 88 to 11 hours ( p < 0.001 ) and the median time from admission to isolation from 96 to 25 hours ( p < 0.001 ) .
RESULTS	MRSA acquisition was detected in 36 patients ( 3.2 % ) in the control arm and 34 ( 3.2 % ) in the intervention arm .
RESULTS	The incidence density rate of hospital acquired MRSA was 2.82 and 2.57 / 1,000 exposed patient-days in the control and intervention arm , respectively ( risk ratio 0.91 ( 95 % confidence interval , 0.60-1 .39 ) .
RESULTS	Poisson regression model adjusted for colonisation pressure , compliance with hand hygiene and antibiotic use indicated a RR 0.99 ( 95 % CI , 0.69 to 1.44 ) .
CONCLUSIONS	Universal PCR screening for MRSA on admission to medical and surgical wards in an endemic setting shortened the time to implement isolation precautions but did not reduce nosocomial acquisition of MRSA .
BACKGROUND	clinicaltrials.gov NCT00846105 .

###24953909
OBJECTIVE	To compare postoperative sensitivity following composite restoration placed in supra gingival class-V cavities using self etch adhesive and total etch adhesive .
METHODS	A randomized clinical trial .
METHODS	Operative Dentistry Department of Armed Forces Institute of Dentistry , Rawalpindi , from July to December 2009 .
METHODS	A total of 70 patients having class-V supra gingival carious lesions were divided into two groups .
METHODS	Classes-V cavities not exceeding 3 mm were prepared .
METHODS	One treatment group was treated with self etch adhesive ( adhe SE one Ivoclar ) and the control group was treated with total-etch adhesive ( Eco-Etch Ivoclar ) after acid etching with 37 % phosphoric acid .
METHODS	Light cured composite ( Te-Econom Ivoclar ) restoration was placed for both groups and evaluated for postoperative sensitivity immediately after restoration , after 24 hours and after one week .
METHODS	Data was recorded on visual analogue scale .
RESULTS	Comparison of sensitivity between the two treatment groups on application cold stimulus after 24 hours of restoration showed significant difference ; however , no statistically significant difference was observed at baseline , immediately after restoration and at 1 week follow-up with cold stimulus or compressed air application .
CONCLUSIONS	Less postoperative sensitivity was observed at postoperative 24 hours assessment in restoration placed using SE adhesives compared to TE adhesives .
CONCLUSIONS	Thus , the use of SE adhesives may be helpful in reducing postoperative sensitivity during 24 hours after restoration placement .

###25316463
OBJECTIVE	To evaluate masticatory efficiency ( ME ) and oral health-related quality of life ( OHRQoL ) in patients rehabilitated with implant-retained mandibular overdentures .
METHODS	In this randomized controlled clinical trial , 50 edentulous patients visiting the Implant Center and Department of Prosthodontics , West China College of Stomatology , Sichuan University , Chengdu , China between June 2010 and June 2012 were selected and received 2 implant-retained mandibular overdenture treatments .
METHODS	All patients were rehabilitated with maxillary complete dentures .
METHODS	The ME and OHRQoL were determined both one month before the mandibular complete denture was anchored to the osseointegrated implants , and 6 months after anchoring .
METHODS	Paired t-tests were used to compare means of ME , and oral health impact profile-49 ( OHIP-49 ) domains scores between pre - and post-implant .
METHODS	Linear regression models were utilized to seek correlations between ME and OHIP domains scores .
RESULTS	The ME increased from pre - to post-implant retained mandibular overdentures significantly ( p < 0.001 ) .
RESULTS	The total OHIP score and 4 subscales scores were changed significantly from pre - to post-implant ; namely , functional limitation , psychological discomfort , physical disability , and physical pain .
RESULTS	The total OHIP score , functional limitation , physical disability , and physical pain subscale scores were related to ME .
CONCLUSIONS	Implant-retained mandibular over dentures can significantly improve patients ' ME and OHRQoL .
CONCLUSIONS	The improvement in OHRQoL is mainly because of the improved ME .
CONCLUSIONS	An improved chewing experience , and pain relief also contributes to improvement of OHRQoL .

###26271132
OBJECTIVE	To observe the clinical efficacy on chronic stable angina pectoris treated with acupuncture at Neiguan ( PC 6 ) and explore the impacts of acupuncture on peripheral blood neutrophil to lymphocyte ratio ( NLR ) in the patients of stable angina pectoris .
METHODS	Thirty patients of chronic stable angina pectoris met the inclusive criteria were randomized into an acupuncture group ( 15 cases ) and a medication group ( 15 cases ) , and a healthy control group ( 15 cases of the same ages ) was set up separately .
METHODS	In the acupuncture group , at the same time of the basic medication , acupuncture was applied to bilateral Neiguan ( PC 6 ) , once every two days , 3 days a week , totally for 4 weeks .
METHODS	In the medication group , the basic medication was applied , without acupuncture intervention .
METHODS	In the healthy control group , no any intervention was applied .
METHODS	The attack frequency of angina pectoris , dose of nitrogly-cerin , the evaluation of visual analogue scale ( VAS ) , Seattle angina questionnaire ( SAQ ) , the six-minute walking test ( 6MWT ) , the self-rating anxiety scale ( SAS ) and the self-rating depression scale ( SDS ) were observed before and after treatment in the subjects .
METHODS	Additionally , the peripheral blood cells were detected to analyze specifically the changes in NLR before and after treatment and observe the relationship between NLR and clinical efficacy .
RESULTS	Compared with the medication group , the attack frequency of angina pectoris was reduced within 30 days ( P < 0.01 ) ; the dose of nitroglycerin was reduced ( P < 0.01 ) ; VAS was reduced ( P < 0.01 ) and SAQ was increased ( P < 0.05 ) in the acupuncture group .
RESULTS	The differences in 6 MWT , SAS and SDS were not significant between the two groups after treatment ( all P > 0.05 ) .
RESULTS	Additionally , compared with the medication group , in 30 days of acupuncture , NLR was reduced apparently in the acupuncture group ( P < 0.05 ) .
CONCLUSIONS	Acupuncture relieves the clinical symptoms of chronic stable angina pectoris , but has not apparent effects on motor ability and psychological health .
CONCLUSIONS	Corresponding to that before treatment , the decreased NRL in the patients of acupuncture group suggests the potential good prognosis on coronary heart disease after acupuncture .

###25554555
BACKGROUND	Guidelines recommending head of bed ( HOB ) elevation greater than 30 to prevent ventilator-associated pneumonia conflict with guidelines to prevent pressure ulcers , which recommend HOB elevation less than 30 .
OBJECTIVE	To examine the feasibility of 45 HOB elevation and describe and compare the occurrence of reflux , aspiration , and pressure ulcer development at 30 and 45 HOB elevation .
METHODS	A randomized 2-day crossover trial was conducted .
METHODS	HOB angle was measured every 30 seconds .
METHODS	Oral and tracheal secretions were analyzed for pepsin presence .
METHODS	Skin was assessed for pressure ulcers .
METHODS	Wilcoxon signed rank tests and Kendall correlations were conducted .
RESULTS	Fifteen patients were enrolled ; 11 completed both days .
RESULTS	Patients were maintained at 30 ( mean , 30 ) for 96 % of minutes and at 45 ( mean , 39 ) for 77 % of minutes .
RESULTS	No patients showed signs of pressure ulcers .
RESULTS	A total of 188 oral secretions were obtained , 82 ( 44 % ) were pepsin-positive ; 174 tracheal secretions were obtained , 108 ( 62 % ) were pepsin-positive .
RESULTS	The median percentage of pepsin-positive oral secretions was not significantly higher ( P = .11 ) at 30 elevation ( 54 % ) than at 45 elevation ( 20 % ) .
RESULTS	The median percentage of pepsin-positive tracheal secretions was not significantly higher ( P = .37 ) at 30 elevation ( 71 % ) than 45 elevation ( 67 % ) .
RESULTS	Deeper sedation correlated with increased reflux ( P = .03 ) .
CONCLUSIONS	HOB elevation greater than 30 is feasible and preferred to 30 for reducing oral secretion volume , reflux , and aspiration without pressure ulcer development in gastric-fed patients receiving mechanical ventilation .
CONCLUSIONS	More deeply sedated patients may benefit from higher HOB elevations .

###25335089
BACKGROUND	Force feedback might improve surgical performance during minimally invasive surgery .
BACKGROUND	This study sought to determine whether training with force feedback shortened the tissue-handling learning curve , and examined the influence of real-time visual feedback compared with postprocessing feedback .
METHODS	Medical students without experience of minimally invasive surgery were randomized into three groups : real-time force feedback , postprocessing force feedback and no force feedback ( control ) .
METHODS	All performed eight suturing tasks consecutively , of which the first and eighth were the premeasurement and postmeasurement tasks respectively ( no feedback ) .
METHODS	Depending on randomization , either form of feedback was given during the second to seventh task .
METHODS	Time , mean force non-zero and maximum force were measured with a force sensor .
METHODS	Results of the groups were compared with one-way ANOVA , and intragroup improvement using a paired-samples t test .
RESULTS	A total of 72 students took part .
RESULTS	Both intervention groups used significantly lower interaction forces than the control group during the knot-tying phase of the postmeasurement task and improved their interaction forces significantly during the knot-tying phase .
RESULTS	The form of feedback did not influence its effectiveness .
CONCLUSIONS	The tissue-handling skills of medical students improved significantly when they were given force feedback of their performance .
CONCLUSIONS	This effect was seen mainly during the knot-tying phase of the suturing task .

###25623520
OBJECTIVE	Despite the efficacy of TNF inhibitors , most patients with psoriatic arthritis maintain a residual synovial inflammation .
OBJECTIVE	The main aim of the study was to evaluate the effects of mud-bath therapy on clinical picture of PsA patients treated with TNF inhibitors .
OBJECTIVE	The secondary outcome was to assess synovial inflammation in hand joints detected by contrast-enhanced ultrasound .
OBJECTIVE	Other aims were to verify the risk of arthritis flare and to evaluate the effects of spa treatment on functional ability and on quality of life .
METHODS	Thirty-six patients with psoriatic arthritis , treated in the last 6 months with TNF inhibitors , were enrolled .
METHODS	After 1:1 randomisation , 18 patients ( group A ) underwent mud-bath therapy ( 12 mudpacks and 12 thermal baths ) , maintaining treatment with TNF inhibitors ; 18 patients ( group B ) continued pharmacological therapy alone .
METHODS	CRP , PASI , DAS28 , swollen and tender joint count , VAS pain , HAQ and SF-36 were evaluated at baseline ( T0 ) and after 45 days ( T1 ) .
METHODS	Synovial inflammation detected by contrast-enhanced ultrasound , analysed by a software system , was also assessed .
RESULTS	A significant improvement in PASI ( P < 0.005 ) , DAS28 ( P < 0.05 ) , swollen joint count and tender joint count ( P < 0.001 ) , and HAQ ( P < 0.001 ) between T0 and T1 was observed in group A. No patient underwent a flare-up of arthritis .
RESULTS	Ultrasound videos demonstrated a significant appearance delay ( P < 0.05 ) and faster washout ( P < 0.02 ) of contrast dye in group A patients with respect to group B.
CONCLUSIONS	These data suggest a decrease of residual synovial inflammation and a beneficial clinical effect of spa therapy in psoriatic arthritis patients treated with TNF inhibitors .

###24997307
BACKGROUND	This longitudinal study examined the association between trajectories of cigarette smoking and unemployment across a 29-year time period from mean age 14 to mean age 43 .
METHODS	Participants came from a community-based random sample of residents in 2 upstate New York counties .
METHODS	Data were collected at 7 timepoints .
RESULTS	Using growth mixture modeling , 5 trajectory groups of cigarette smokers were identified .
RESULTS	The trajectory groups were as follows : heavy/continuous smokers , occasional smokers , late-starting smokers , quitters/decreasers , and nonsmokers .
RESULTS	Multivariate logistic regression analysis was used to study the relationship between the participant 's trajectory group membership and unemployment in the fifth decade of life .
RESULTS	The association was determined with controls for age , gender , current cigarette use , current alcohol use , current marijuana use , physical diseases , occupation , educational level , past unemployment experience , socioeconomic status measures of family of origin , depressive mood , and self-control from adolescence through the early 40s .
RESULTS	The findings indicate that patterns of adolescent and young adult cigarette smoking have implications for later unemployment .
RESULTS	Overall , the results showed that people who fell into the categories of heavy/continuous smokers ( adjusted odds ratio [ AOR ] = 3.84 ) and occasional smokers ( AOR = 4.03 ) were more likely to be unemployed at mean age 43 when compared with nonsmokers .
RESULTS	There was no significant difference between the quitters/decreasers and the nonsmokers with respect to unemployment .
CONCLUSIONS	Intervention programs designed to deal with unemployment should consider focusing on heavy/continuous and occasional cigarette smokers as risk factors for unemployment .

###25091664
BACKGROUND	Rotavirus infections , prevalent in human populations worldwide are mostly caused by Group A viruses .
BACKGROUND	Live attenuated rotavirus vaccines are highly effective in preventing severe rotavirus gastroenteritis .
BACKGROUND	However , the cost of these vaccines and local availability can be a barrier for widespread adoption in public health programs in developing countries where infants suffer a heavy burden of rotavirus related morbidity and mortality .
BACKGROUND	A phase I/II study was carried out with the long term aim to produce a locally licensed vaccine which is equally safe and immunogenic as compared to available licensed vaccines .
METHODS	This study was conducted in two cohorts .
METHODS	In the first cohort , 20 healthy adults were administered a single dose of the rotavirus vaccine ( highest antigen concentration planned for infants ) or placebo and were followed up for 10 days for safety .
METHODS	Following demonstration of safety in adult volunteers , 100 healthy infants were recruited ( cohort 2 ) and randomly divided into five equal study groups .
METHODS	They were administered three doses of either the investigational rotavirus vaccine ( BRV-TV ) at one of the three antigen concentrations or Rotateq or Placebo at 6-8 , 10-12 and 14-16 weeks of age .
METHODS	All infants were followed up for safety till 28 days after the third dose .
METHODS	Immune response to the vaccine , in terms of seroresponse and geometric mean concentrations , was compared across the five study groups .
RESULTS	Increase in anti-rotavirus serum IgA antibodies from baseline , demonstrated higher immune response for all the three antigen concentrations of BRV-TV vaccine and RotaTeq in comparison with the placebo .
RESULTS	Sero-response rates for placebo , BRV-TV dose-levels 10 ( 5.0 ) FFU , 10 ( 5.8 ) FFU , 10 ( 6.4 ) FFU , and Rotateq at 28 days post third dose were 11.1 % , 27.8 % , 41.2 % , 83.3 % , and 63.2 % respectively using the four-fold or more criteria .
RESULTS	The BRV-TV vaccine arm corresponding to the highest antigen concentration of 10 ( 6.4 ) FFU had a higher sero-response rate compared to the active comparator arm ( RotaTeq ) , 28 days post each vaccine dose .
RESULTS	The safety profile was comparable across the treatment groups .
CONCLUSIONS	Overall , the results showed that all three doses of BRV-TV vaccine were safe , well tolerated and displayed good immunogenicity ( dose-response ) in healthy Indian infants .

###26030518
BACKGROUND	Growth of hormone-receptor-positive breast cancer is dependent on cyclin-dependent kinases 4 and 6 ( CDK4 and CDK6 ) , which promote progression from the G1 phase to the S phase of the cell cycle .
BACKGROUND	We assessed the efficacy of palbociclib ( an inhibitor of CDK4 and CDK6 ) and fulvestrant in advanced breast cancer .
METHODS	This phase 3 study involved 521 patients with advanced hormone-receptor-positive , human epidermal growth factor receptor 2-negative breast cancer that had relapsed or progressed during prior endocrine therapy .
METHODS	We randomly assigned patients in a 2:1 ratio to receive palbociclib and fulvestrant or placebo and fulvestrant .
METHODS	Premenopausal or perimenopausal women also received goserelin .
METHODS	The primary end point was investigator-assessed progression-free survival .
METHODS	Secondary end points included overall survival , objective response , rate of clinical benefit , patient-reported outcomes , and safety .
METHODS	A preplanned interim analysis was performed by an independent data and safety monitoring committee after 195 events of disease progression or death had occurred .
RESULTS	The median progression-free survival was 9.2 months ( 95 % confidence interval [ CI ] , 7.5 to not estimable ) with palbociclib-fulvestrant and 3.8 months ( 95 % CI , 3.5 to 5.5 ) with placebo-fulvestrant ( hazard ratio for disease progression or death , 0.42 ; 95 % CI , 0.32 to 0.56 ; P < 0.001 ) .
RESULTS	The most common grade 3 or 4 adverse events in the palbociclib-fulvestrant group were neutropenia ( 62.0 % , vs. 0.6 % in the placebo-fulvestrant group ) , leukopenia ( 25.2 % vs. 0.6 % ) , anemia ( 2.6 % vs. 1.7 % ) , thrombocytopenia ( 2.3 % vs. 0 % ) , and fatigue ( 2.0 % vs. 1.2 % ) .
RESULTS	Febrile neutropenia was reported in 0.6 % of palbociclib-treated patients and 0.6 % of placebo-treated patients .
RESULTS	The rate of discontinuation due to adverse events was 2.6 % with palbociclib and 1.7 % with placebo .
CONCLUSIONS	Among patients with hormone-receptor-positive metastatic breast cancer who had progression of disease during prior endocrine therapy , palbociclib combined with fulvestrant resulted in longer progression-free survival than fulvestrant alone .
CONCLUSIONS	( Funded by Pfizer ; PALOMA3 ClinicalTrials.gov number , NCT01942135 . )

###24304478
OBJECTIVE	To investigate the effectiveness of self-weighing twice a day with a supportive program installed on a body composition monitor in overweight adults .
METHODS	Sixty adults with BMI > 24 kg/m ( 2 ) were randomly assigned to either a group that weighed themselves once per day ( group 1 , n = 30 ) or a group that weighed themselves twice per day ( group 2 , n = 30 ) .
METHODS	Group 1 was instructed to self-weigh at the same time once per day and group 2 was instructed to self-weigh immediately after waking up in the morning and immediately before going to bed every day for twelve weeks .
METHODS	In addition , participants in group 2 was received the daily target setting during morning weighing and the difference between the measured weight and the target weight during bedtime weighing .
RESULTS	Average weight reduction in group 1 was significantly lower than that in group 2 ( 1.0 1.4 kg vs. 2.7 2.1 kg , p < 0.05 ) .
RESULTS	The proportion of participants who lost 5 % of their pre-program weight in group 2 was significantly higher than that in group 1 ( 28.6 % vs. 3.6 % , p < 0.05 ) .
CONCLUSIONS	A self-weighing twice per day plus daily target setting and feedback is more effective in promoting weight loss than once-daily self-measurement .

###24913347
OBJECTIVE	The DiaMind trial showed beneficial immediate effects of mindfulness-based cognitive therapy ( MBCT ) on emotional distress , but not on diabetes distress and HbA1c .
OBJECTIVE	The aim of the present report was to examine if the effects would be sustained after six month follow-up .
METHODS	In the DiaMind trial , 139 outpatients with diabetes ( type-I or type-II ) and a lowered level of emotional well-being were randomized into MBCT ( n = 70 ) or a waiting list with treatment as usual ( TAU : n = 69 ) .
METHODS	Primary outcomes were perceived stress , anxiety and depressive symptoms , and diabetes distress .
METHODS	Secondary outcomes were , among others , health status , and glycemic control ( HbA1c ) .
RESULTS	Compared to TAU , MBCT showed sustained reductions at follow-up in perceived stress ( p < .001 , d = .76 ) , anxiety ( p < .001 , assessed by HADS d = .83 ; assessed by POMS d = .92 ) , and HADS depressive symptoms ( p = .004 , d = .51 ) , but not POMS depressive symptoms when using Bonferroni correction for multiple testing ( p = .016 , d = .48 ) .
RESULTS	No significant between-group effect was found on diabetes distress and HbA1c .
CONCLUSIONS	This study showed sustained benefits of MBCT six months after the intervention on emotional distress in people with diabetes and a lowered level of emotional well-being .
BACKGROUND	Dutch Trial Register NTR2145 , http://www.trialregister.nl .

###24717377
OBJECTIVE	Cost-effectiveness of treatment for posttraumatic stress disorder ( PTSD ) may depend on type of treatment ( eg , pharmacotherapy vs psychotherapy ) and patient choice of treatment .
OBJECTIVE	We examined the cost-effectiveness of treatment with prolonged exposure therapy versus pharmacotherapy with sertraline , overall treatment preference , preference for choosing prolonged exposure therapy , and preference for choosing pharmacotherapy with sertraline from the US societal perspective .
METHODS	Two hundred patients aged 18 to 65 years with PTSD diagnosis based on DSM-IV criteria enrolled in a doubly randomized preference trial .
METHODS	Patients were randomized to receive their treatment of choice ( n = 97 ) or to be randomly assigned treatment ( n = 103 ) .
METHODS	In the choice arm , patients chose either prolonged exposure therapy ( n = 61 ) or pharmacotherapy with sertraline ( n = 36 ) .
METHODS	In the no-choice arm , patients were randomized to either prolonged exposure therapy ( n = 48 ) or pharmacotherapy with sertraline ( n = 55 ) .
METHODS	The total costs , including direct medical costs , direct nonmedical costs , and indirect costs , were estimated in 2012 US dollars ; and total quality-adjusted life-year ( QALY ) was assessed using the EuroQoL Questionnaire-5 dimensions ( EQ-5D ) instrument in a 12-month period .
METHODS	This study was conducted from July 2004 to January 2009 .
RESULTS	Relative to pharmacotherapy with sertraline , prolonged exposure therapy was less costly ( - $ 262 ; 95 % CI , - $ 5,068 to $ 4,946 ) and produced more QALYs ( 0.056 ; 95 % CI , 0.014 to 0.100 ) when treatment was assigned , with 93.2 % probability of being cost-effective at $ 100,000 / QALY .
RESULTS	Independently , giving a choice of treatment also yielded lower cost ( - $ 1,826 ; 95 % CI , - $ 4,634 to $ 749 ) and more QALYs ( 0.010 ; 95 % CI , -0.019 to 0.044 ) over no choice of treatment , with 87.0 % probability of cost-effectiveness at $ 100,000 / QALY .
CONCLUSIONS	Giving PTSD patients a choice of treatment appears to be cost-effective .
CONCLUSIONS	When choice is not possible , prolonged exposure therapy may provide a cost-effective option over pharmacotherapy with sertraline .
BACKGROUND	ClinicalTrials.gov identifier : NCT00127673 .

###24244656
OBJECTIVE	To determine the effects of combined aerobic and resistance exercise training during the second half of pregnancy on endothelial NOS expression ( eNOS ) , nitric oxide ( NO ) production and oxygen metabolism in human placenta .
METHODS	The study included 20 nulliparous in gestational week 16-20 , attending prenatal care at three tertiary hospitals in Colombia who were randomly assigned into one of two groups : The exercise group ( n = 10 ) took part in an exercise session three times a week for 12 weeks which consisted of : aerobic exercise at an intensity of 55-75 % of their maximum heart rate for 60 min and 25 mins .
METHODS	Resistance exercise included 5 exercise groups circuit training ( 50 repetitions of each ) using barbells ( 1-3 kg/exercise ) and low-to-medium resistance bands .
METHODS	The control group ( n = 10 ) undertook their usual physical activity .
METHODS	Mitochondrial and cytosol fractions were isolated from human placental tissue by differential centrifugation .
METHODS	A spectrophotometric assay was used to measure NO production in cytosolic samples from placental tissue and Western Blot technique to determine eNOS expression .
METHODS	Mitochondrial superoxide levels and hydrogen peroxide were measured to determine oxygen metabolism .
RESULTS	Combined aerobic and resistance exercise training during pregnancy leads to a 2-fold increase in eNOS expression and 4-fold increase in NO production in placental cytosol ( p = 0.05 ) .
RESULTS	Mitochondrial superoxide levels and hydrogen peroxide production rate were decreased by 8 % and 37 % respectively in the placental mitochondria of exercising women ( p = 0.05 ) .
CONCLUSIONS	Regular exercise training during the second half of pregnancy increases eNOS expression and NO production and decreases reactive oxygen species generation in human placenta .
CONCLUSIONS	Collectively , these data demonstrate that chronic exercise increases eNOS/NO production , presumably by increasing endothelial shear stress .
CONCLUSIONS	This adaptation may contribute to the beneficial effects of exercise on the vascular and antioxidant system and in turn reduce the risk of preeclampsia , diabetes or hypertension during pregnancy .

###24673056
OBJECTIVE	To compare differences of clinical therapeutic effect of heat-sensitive moxibustion with different doses for irritable bowel syndrome ( IBS ) .
METHODS	Sixty cases of IBS were randomly divided into a saturated-dose group ( 30 cases ) and a traditional-dose group ( 30 cases ) .
METHODS	Heat-sensitive moxibustion was applied in both groups .
METHODS	The acupoints that had the strongest heat-sensitive feeling were selected and treated by warm and suspended moxibustion with moxa stick .
METHODS	Disappearance of heat-sensitive feeling was taken as the sign of treatment time in the saturated-dose group , while the traditional-dose group was treated for 15 min each time .
METHODS	The treatment in both groups was given twice a day for first 5 days , and from the sixth day it was given once a day for continuous 25 times , totally 30 days .
METHODS	Clinical symptom scores and therapeutic effect before and after treatment in two groups were observed .
RESULTS	After the treatment , the cured and markedly effective rate was 75.0 % ( 21/28 ) in the saturated-dose group , which was inferior to 44.4 % ( 12/27 ) in the traditional-dose group ( P < 0.05 ) .
RESULTS	The clinical symptom scores , including diarrhea , abdominal distension and pain , were obviously reduced in two groups compared with those before the treatment ( all P < 0.05 ) .
RESULTS	Compared with the traditional-dose group , the symptom scores of diarrhea and abdominal distension in the saturated-dose group were obviously decreased ( 0.87 + / - 0.13 vs 1.27 + / - 0.21 , P < 0.01 ; 1.12 + / - 0.41 vs 1.32 + / - 0.26 , P < 0.05 ) .
CONCLUSIONS	The moxibustion featured with disappearance of heat-sensitive feeling and saturated dose has better therapeutic effect than that with traditional-dose for treatment of IBS .
CONCLUSIONS	As individual dynamic amount of moxibustion , disappearance of heat-sensitive and quantitation varies from person to person , which is one of the key factors to obtain the best curative effect .

###24846619
BACKGROUND	Interventions requiring abstinence from alcohol are neither preferred by nor shown to be highly effective with many homeless individuals with alcohol dependence .
BACKGROUND	It is therefore important to develop lower-threshold , patient-centered interventions for this multimorbid and high-utilizing population .
BACKGROUND	Harm-reduction counseling requires neither abstinence nor use reduction and pairs a compassionate style with patient-driven goal-setting .
BACKGROUND	Extended-release naltrexone ( XR-NTX ) , a monthly injectable formulation of an opioid receptor antagonist , reduces craving and may support achievement of harm-reduction goals .
BACKGROUND	Together , harm-reduction counseling and XR-NTX may support alcohol harm reduction and quality-of-life improvement .
OBJECTIVE	Study aims include testing : a ) the relative efficacy of XR-NTX and harm-reduction counseling compared to a community-based , supportive-services-as-usual control , b ) theory-based mediators of treatment effects , and c ) treatment effects on publicly funded service costs .
METHODS	This RCT involves four arms : a ) XR-NTX + harm-reduction counseling , b ) placebo + harm-reduction counseling , c ) harm-reduction counseling only , and d ) community-based , supportive-services-as-usual control conditions .
METHODS	Participants are currently/formerly homeless , alcohol dependent individuals ( N = 300 ) .
METHODS	Outcomes include alcohol variables ( i.e. , craving , quantity/frequency , problems and biomarkers ) , health-related quality of life , and publicly funded service utilization and associated costs .
METHODS	Mediators include 10-point motivation rulers and the Penn Alcohol Craving Scale .
METHODS	XR-NTX and harm-reduction counseling are administered every 4weeks over the 12-week treatment course .
METHODS	Follow-up assessments are conducted at weeks 24 and 36 .
CONCLUSIONS	If found efficacious , XR-NTX and harm-reduction counseling will be well-positioned to support reductions in alcohol-related harm , decreases in costs associated with publicly funded service utilization , and increases in quality of life among homeless , alcohol-dependent individuals .

###24289513
BACKGROUND	The Protocolised Management in Sepsis ( ProMISe ) trial is an open , multicentre , randomised controlled trial ( RCT ) of the clinical effectiveness and cost-effectiveness of early , goal directed , protocolised resuscitation compared with usual resuscitation for patients presenting to emergency departments ( EDs ) in the United Kingdom with early signs of severe sepsis or septic shock .
BACKGROUND	The rationale for the ProMISe trial derives from a single-centre United States RCT that reported a reduction in hospital mortality from 46.5 % to 30.5 % .
OBJECTIVE	To describe the proposed statistical analyses for the evaluation of clinical effectiveness for the ProMISe trial .
OBJECTIVE	It is important to complete this plan before inspecting the data , and before completion of two related international studies , so that post-hoc , data-derived decisions are avoided .
METHODS	The primary and secondary outcomes were defined precisely , and the approach to safety monitoring and data collection summarised , with a description of the planned statistical analyses including prespecified subgroup and secondary analyses .
RESULTS	The primary outcome is all-cause mortality at 90 days .
RESULTS	The primary analysis will be reported as a relative risk and absolute risk reduction and tested with the Fisher exact test .
RESULTS	Prespecified subgroup analyses will be based on age , baseline Medical Emergency Department Sepsis score , baseline Sequential Organ Failure Assessment score , and time from ED presentation to randomisation .
RESULTS	Secondary analyses include adjustment for baseline covariates , estimation of learning curve effects and adjustment for noncompliance .
CONCLUSIONS	In keeping with best practice , we have developed a statistical analysis plan for the ProMISe trial and place it in the public domain before inspecting data from the trial .

###25370587
OBJECTIVE	Prompt thrombolytic therapy with intravenous alteplase reduces disability after acute ischemic stroke .
OBJECTIVE	In an exploratory analysis , we examined whether long-term survival varied by baseline characteristics after alteplase .
METHODS	In this open-treatment , international , randomized , controlled trial , ischemic stroke patients were randomly allocated < 6 hours of onset to intravenous alteplase ( 0.9 mg/kg ) plus standard care ( n = 1515 ) or standard care alone ( n = 1520 ) .
METHODS	We followed patients to death , censoring when last known to be alive .
METHODS	We grouped patients by delay to randomization , and good or poor predicted prognosis ( calculated from baseline National Institutes of Health Stroke Scale [ NIHSS ] score and age ) .
METHODS	We present absolute mortality differences between treated and control groups at 7 days , 6 months , and 18 months poststroke .
RESULTS	Alteplase was not associated with a significant increase in mortality within 18 months ( 0.6 % [ 95 % confidence interval ( CI ) , -2.9 % to +4.2 ] P = 0.72 ] in all patients with complete vital status ( 99.9 % , 3034/3035 ) .
RESULTS	In patients randomized < 3 hours of stroke , 18-month mortality was lower in the alteplase-treated group than the control group ( 40.6 % [ 95 % CI , 42.6-52 .7 ] versus 47.8 % [ 95 % CI , 35.5-45 .3 ] ; P = 0.0434 ] .
RESULTS	The difference in 18-month mortality between alteplase-treated and control patients was greater in patients who were randomized early ( < 3 hours ) compared with late ( 3-6 hours ; +9 % [ 95 % CI , 1-17 ] ; P = 0.0317 ) .
RESULTS	Alteplase led to a greater improvement in 18-month survival in patients with a poor prognosis than in patients with a good prognosis ( +8 % [ 95 % CI , 2-14 ] ; P = 0.0091 ) .
CONCLUSIONS	These exploratory analyses of the third International Stroke Trial ( IST-3 ) trial support improving acute stroke patients ' access to earlier alteplase treatment , treatment of patients with poor prognosis , and further randomized controlled trials in minor stroke to replicate these findings .
BACKGROUND	http://www.controlled-trials.com .
BACKGROUND	Unique identifier : ISRCTN25765518 .

###25066248
BACKGROUND	Thrombophilias are common disorders that increase the risk of pregnancy-associated venous thromboembolism and pregnancy loss and can also increase the risk of placenta-mediated pregnancy complications ( severe pre-eclampsia , small-for-gestational-age infants , and placental abruption ) .
BACKGROUND	We postulated that antepartum dalteparin would reduce these complications in pregnant women with thrombophilia .
METHODS	In this open-label randomised trial undertaken in 36 tertiary care centres in five countries , we enrolled consenting pregnant women with thrombophilia at increased risk of venous thromboembolism or with previous placenta-mediated pregnancy complications .
METHODS	Eligible participants were randomly allocated in a 1:1 ratio to either antepartum prophylactic dose dalteparin ( 5000 international units once daily up to 20 weeks ' gestation , and twice daily thereafter until at least 37 weeks ' gestation ) or to no antepartum dalteparin ( control group ) .
METHODS	Randomisation was done by a web-based randomisation system , and was stratified by country and gestational age at randomisation day with a permuted block design ( block sizes 4 and 8 ) .
METHODS	At randomisation , site pharmacists ( or delegates ) received a randomisation number and treatment allocation ( by fax and/or e-mail ) from the central web randomisation system and then dispensed study drug to the local coordinator .
METHODS	Patients and study personnel were not masked to treatment assignment , but the outcome adjudicators were masked .
METHODS	The primary composite outcome was independently adjudicated severe or early-onset pre-eclampsia , small-for-gestational-age infant ( birthweight < 10th percentile ) , pregnancy loss , or venous thromboembolism .
METHODS	We did intention-to-treat and on-treatment analyses .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00967382 , and with Current Controlled Trials , number ISRCTN87441504 .
RESULTS	Between Feb 28 , 2000 , and Sept 14 , 2012 , 292 women consented to participate and were randomly assigned to the two groups .
RESULTS	Three women were excluded after randomisation because of ineligibility ( two in the antepartum dalteparin group and one in the control group ) , leaving 146 women assigned to antepartum dalteparin and 143 assigned to no antepartum dalteparin .
RESULTS	Some patients crossed over to the other group during treatment , and therefore for on-treatment and safety analysis there were 143 patients in the dalteparin group and 141 in the no dalteparin group .
RESULTS	Dalteparin did not reduce the incidence of the primary composite outcome in both intention-to-treat analysis ( dalteparin 25/146 [ 171 % ; 95 % CI 114-242 % ] vs no dalteparin 27/143 [ 189 % ; 95 % CI 128-263 % ] ; risk difference -18 % [ 95 % CI -106 % to 71 % ) ) and on-treatment analysis ( dalteparin 28/143 [ 196 % ] vs no dalteparin 24/141 [ 170 % ] ; risk difference +26 % [ 95 % CI -64 to 116 % ] ) .
RESULTS	In safety analysis , the occurrence of major bleeding did not differ between the two groups .
RESULTS	However , minor bleeding was more common in the dalteparin group ( 28/143 [ 196 % ] ) than in the no dalteparin group ( 13/141 [ 92 % ] ; risk difference 104 % , 95 % CI 23-184 ; p = 001 ) .
CONCLUSIONS	Antepartum prophylactic dalteparin does not reduce the occurrence of venous thromboembolism , pregnancy loss , or placenta-mediated pregnancy complications in pregnant women with thrombophilia at high risk of these complications and is associated with an increased risk of minor bleeding .
BACKGROUND	Canadian Institutes of Health Research , Heart and Stroke Foundation of Canada , and Pharmacia and UpJohn .

###24393781
OBJECTIVE	To compare a walking reeducation program with robotic locomotor training plus overground therapy ( LKOGT ) to conventional overground training ( OGT ) in individuals with incomplete upper motor neuron ( UMN ) or lower motor neuron ( LMN ) injuries having either traumatic or nontraumatic nonprogressive etiology .
METHODS	Randomized open controlled trial with blind evaluation by an independent observer .
METHODS	An inpatient spinal cord injury rehabilitation center .
METHODS	A total of 88 adults within 6 months of spinal cord injury onset ( group A , 44 with UMN injury , and group B , 44 with LMN injury ) were graded on the American Spinal Injury Association Impairment Scale as C or D. Each of these groups was then randomly allocated to conditions 1 or 2 .
METHODS	Condition 1 : Subgroups A1 and B1 were treated with LKOGT for 60 minutes .
METHODS	Condition 2 : Subgroups A2 and B2 received 60 minutes of conventional OGT 5 days per week for 8 weeks .
METHODS	Subjects with UMN and LMN were randomized into 2 training groups .
METHODS	Ten-meter walk test and 6-minute walk test ( 6MWT ) .
METHODS	Walking Index for Spinal Cord Injury II , lower extremity motor score ( LEMS ) , and the FIM-Locomotor were secondary outcome measures .
RESULTS	By using the LKOGT program compared with OGT , we found significant differences in the 6MWT for groups A1 and B1 .
RESULTS	LKOGT also provided higher scores than did OGT in secondary outcomes such as the LEMS and the FIM-Locomotor .
CONCLUSIONS	Robotic-assisted step training yielded better results in the 6MWT and the LEMS in patients with UMN and LMN .

###25019487
OBJECTIVE	This planned secondary analysis of the Outcomes Following Vaginal Prolapse Repairs and Midurethral Sling trial assessed whether treatment knowledge differed between randomized groups at 12 months and whether treatment success was affected by treatment perception .
METHODS	Sham suprapubic tension-free vaginal tape ( TVT ) incisions were made in the Outcomes Following Vaginal Prolapse Repairs and Midurethral Sling trial participants randomized to no-TVT .
METHODS	Primary surgical outcomes and maintenance of blinding was assessed at 12 months .
METHODS	Knowledge of treatment assignment was compared between groups , and the relationship with treatment success rates was assessed .
RESULTS	Prior to the 12 month postoperative visit , only 4 % of treated participants ( 13 of 336 ) formally reported unmasking .
RESULTS	At 12 months , 94 % of the randomized participants ( 315 of 336 ) provided treatment knowledge data .
RESULTS	Sixteen TVT participants ( 10 % ) reported treatment knowledge ; most ( n = 15 , 94 % ) were correct ; 17 of the sham participants ( 11 % ) reported treatment knowledge ; half ( n = 8 , 47 % ) were correct .
RESULTS	Similar proportions of unmasked participants who reported no treatment knowledge correctly guessed/perceived treatment assignment ( sham , 46 [ 33 % ] vs TVT , 44 [ 33 % ] ) .
RESULTS	We did not detect significant differences in treatment success rates based on perception within and across received treatment groups ( perceived sham vs TVT overall [ P = .76 ] ) .
RESULTS	Of those receiving TVT , more participants perceiving TVT had treatment success compared with those who perceived sham ( 84 % vs 74 % ; P = .29 ) .
RESULTS	Among sham participants , more participants perceiving sham had success compared with those who perceived receiving TVT ( 65 % vs 56 % ; P = .42 ) .
CONCLUSIONS	Sham surgical incisions effectively mask TVT randomization .
CONCLUSIONS	These findings may help to inform future surgical trial designs .

###25840082
OBJECTIVE	Tubeless mini-percutaneous nephrolithotomy ( MPCNL ) for treating renal calculi was introduced in response to concerns over the use of adult nephrolithotomy apparatus in small children .
OBJECTIVE	However , it is unclear whether tubeless mini-PCNL ( MPCNL ) is of any benefit in the treatment of children .
OBJECTIVE	This study therefore aimed to assess the possible benefits of MPCNL , as compared to standard PCNL , in preschool children .
METHODS	Seventy-eight preschool children under 3 years with renal calculi were randomized into two groups ( PCNL and MPCNL ) .
METHODS	Operative time , hemoglobin decrease , blood transfusion rate , postoperative complications and length of hospital stay in the two groups were statistically compared .
RESULTS	Recovery time was significantly shorter for patients receiving MPCNL than those treated with standard PCNL ( 4.6 versus 7.7 days , P < 0.05 ) .
CONCLUSIONS	Treating preschool children with tubeless percutaneous nephrolithotomy has advantages over standard PCNL , including faster recovery and shorter hospital stay .

###25114296
OBJECTIVE	Insulin degludec/liraglutide ( IDegLira ) is a novel combination of insulin degludec ( IDeg ) and liraglutide .
OBJECTIVE	This trial investigated the contribution of the liraglutide component of IDegLira versus IDeg alone on efficacy and safety in patients with type 2 diabetes .
METHODS	In a 26-week , double-blind trial , patients with type 2 diabetes ( A1C 7.5-10 .0 % [ 58-86 mmol/mol ] ) on basal insulin ( 20-40 units ) and metformin with or without sulfonylurea/glinides were randomized ( 1:1 ) to once-daily IDegLira + metformin or IDeg + metformin with titration aiming for fasting plasma glucose between 4 and 5 mmol/L .
METHODS	Maximum allowed doses were 50 dose steps ( equal to 50 units IDeg plus 1.8 mg liraglutide ) and 50 units for IDeg .
METHODS	The primary end point was change in A1C from baseline .
RESULTS	A total of 413 patients were randomized ( mean A1C 8.8 % [ 73 mmol/mol ] ; BMI 33.7 kg/m2 ) .
RESULTS	IDeg dose , alone or as part of IDegLira , was equivalent ( 45 units ) .
RESULTS	A1C decreased by 1.9 % ( 21 mmol/mol ) with IDegLira and by 0.9 % ( 10 mmol/mol ) with IDeg ( estimated treatment difference -1.1 % [ 95 % CI -1.3 , -0.8 ] , -12 mmol/mol [ 95 % CI -14 , -9 ; P < 0.0001 ) .
RESULTS	Mean weight reduction with IDegLira was 2.7 kg vs. no weight change with IDeg , P < 0.0001 .
RESULTS	Hypoglycemia incidence was comparable ( 24 % for IDegLira vs. 25 % for IDeg ) .
RESULTS	Overall adverse events were similar , and incidence of nausea was low in both groups ( IDegLira 6.5 % vs. IDeg 3.5 % ) .
CONCLUSIONS	IDegLira achieved glycemic control superior to that of IDeg at equivalent insulin doses without higher risk of hypoglycemia and with the benefit of weight loss .
CONCLUSIONS	These findings establish the efficacy and safety of IDegLira and the distinct contribution of the liraglutide component .

###25315941
OBJECTIVE	To assess the feasibility , safety , and effectiveness of early rapid icy normal saline infusion to attain mild hypothermia in cardiac arrest patients .
METHODS	A single-center prospective randomized controlled trial was conducted .
METHODS	From March 2011 to October 2013 , patients who had recovery of spontaneous circulation ( ROSC ) after cardiopulmonary resuscitation ( CPR ) in Beijing Daxing District People 's Hospital were randomly divided into two groups .
METHODS	In icy normal saline group , patients received a rapid infusion of 1 000 mL of 4 centigrade normal saline intravenously to attain a mild hypothermia .
METHODS	In the control group , the patients were treated with ice bag on head , and axillary temperature was monitored .
METHODS	For all patients , rectal temperature was measured and recorded immediately and 1 hour later .
METHODS	The occurrence of pulmonary edema on initial chest X-ray at 6 hours , occurrence of tremor within 48 hours , ventricular fibrillation recurring within 48 hours , and consciousness or death within 14 days were recorded .
RESULTS	A total of 45 patients were enrolled , including 23 patients in icy normal saline group and 22 in control group .
RESULTS	The patients in icy normal saline group had a rectal temperature descended from ( 36.7 0.9 ) centigrade to ( 34.9 0.7 ) centigrade 1 hour later , while the patients in control group had a rectal temperature risen from ( 36.5 1.0 ) centigrade to ( 37.9 0.9 ) centigrade 1 hour later .
RESULTS	There was significant difference in rectal temperature between two groups ( t = 2.228 , P = 0.031 ) .
RESULTS	The number of patients who successfully awaken within 14 days in ice normal saline group was significantly larger than that in control group ( 13 cases vs. 7 cases , = 65.710 , P = 0.021 ) .
RESULTS	There was no statistical difference in the occurrence of acute pulmonary edema ( 4 cases vs. 6 cases ) , tremor ( 2 cases vs. 0 case ) , ventricular fibrillation recurrence ( 4 cases vs. 5 cases ) and death within 14 days ( 11 cases vs. 12 cases , all P > 0.05 ) .
CONCLUSIONS	The study shows that early rapid i.v. infusion of 4 centigrade normal saline is feasible , safe and effective for cerebral resuscitation .

###24603054
OBJECTIVE	To compare in a randomised trial the safety and efficacy of the FemoSeal vascular closure device ( VCD ) versus manual compression ( MC ) after femoral access coronary angiography ( CAG ) .
RESULTS	In 13 months , 1,014 patients were included and 1,001 patients entered analysis .
RESULTS	Median [ interquartile range ] closure time was 8.0 [ 6-10 ] minutes after MC versus 1.0 [ 1-1 ] minute ( p < 0.0001 ) for the FemoSeal VCD .
RESULTS	Bed rest for one hour after the closure procedure was recommended in both groups .
RESULTS	The primary endpoint of incidence of large groin haematoma was 6.7 % in the MC group vs. 2.2 % ( p = 0.002 ) in the FemoSeal group .
RESULTS	The combined endpoint of 14-day adverse vascular events occurred in 1.0 % in the MC group vs. 0.6 % in the FemoSeal VCD group ( p = 0.7 ) .
RESULTS	Manual compression ( OR 3.3 , 95 % CI : 1.5-7 .2 , p = 0.002 ) , female gender ( OR 2.1 , 95 % CI : 1.1-3 .9 , p = 0.018 ) , and multiple punctures ( OR 10.5 , 95 % CI : 3.2-34 .3 , p = 0.001 ) were identified as independent predictors of adverse events and large haematomas .
CONCLUSIONS	Closure of femoral access after coronary angiography by the FemoSeal vascular closure device was safe , faster , and associated with significantly fewer in-hospital large haematomas as compared to closure by manual compression .

###24798419
BACKGROUND	Type 2 diabetes is a common metabolic disease with the potential for prevention of complications .
BACKGROUND	The prevention requires a high level of lasting actions from the patients , which may be burdensome .
BACKGROUND	The aim of this trial was to evaluate the effectiveness of a training course for general practice nurses in motivation support at 18 months follow-up in the affiliated type 2 diabetes population .
METHODS	Forty general practices with nurse-led diabetes consultations from the area of Aarhus , Denmark were randomised 11 to either intervention or usual practice .
METHODS	Intervention practices were offered a 16-hour Self-determination theory-based course including communication training for general practice nurses delivered over 10 months .
METHODS	The affiliated diabetes populations ( aged 40-74 years ) were identified from registers ( intervention n = 2,005 ; usual n = 2,029 ) .
METHODS	Primary outcomes were register-based glycated haemoglobin ( HbA1c ) - , total cholesterol levels , and well-being measured by the Problem Areas In Diabetes scale ( PAID ) and the mental component summary score , SF12 ( SF12 , mcs ) .
METHODS	Intention-to-treat analyses were performed .
METHODS	Predefined subgroups analyses were performed .
RESULTS	The differences between the intervention - and the control practices ' mean HbA1c and total cholesterol at follow-up adjusted for baseline values and clustering were respectively : -0.02 % - points ( 95 % CI : -0.11 to 0.07 ; p : 0.67 ) ; 0.08 mmol/l ( 95 % CI : 0.01 to 0.15 ; p : 0.02 ) .
RESULTS	Differences in median scores adjusted for clustering were for PAID : 1.25 ; p = 0.31 and SF12 , mcs : 0.99 ; p = 0.15 .
RESULTS	Women in intervention practices differed from women in usual practices on mean HbA1c : -0.12 % - points ( -0.23 to -0.02 ; p = 0.02 ) and SF12 , mcs : 2.6 ; p = 0.01 .
CONCLUSIONS	Offering a training course for general practice nurses in applying the Self-determination theory in current type 2 diabetes care had no effect compared with usual practice measured by HbA1c and total cholesterol levels and the well-being at 18 months of follow-up in a comprehensive register-based diabetes population .
CONCLUSIONS	Subgroup analyses suggested a possible effect in women , which deserves further attention .
BACKGROUND	ClinicalTrials.gov ( Identifier NCT01187069 ) .

###24553479
OBJECTIVE	To investigate the efficacy of the intraoperative posterior pericardial window technique in preventing pericardial tamponade following open heart surgery .
METHODS	Adult patients undergoing coronary and/or valve surgery were randomly divided into a control ( traditional ) or a pericardial window ( PW ) technique group .
METHODS	Pre - , intra - , peri - and postoperative clinical data were collected prospectively , including incidence of pericardial tamponade , cardiac arrest , drainage volume , ventilation assistance time and moderate-to-large pericardial effusion .
RESULTS	In total , 458 patients were included : 230 controls and 228 in the PW group .
RESULTS	The incidence of pericardial tamponade in the PW group was significantly lower than in controls .
RESULTS	Cardiac arrest occurred in one patient ( 0.4 % ) in the PW group and five ( 2.2 % ) controls ; this difference was not statistically significant .
RESULTS	Moderate-to-large pericardial effusion after drainage extubation and new-onset atrial fibrillation were significantly more common in controls than in the PW group .
RESULTS	After stratification by age ( 70 versus > 70 years ) , there was no between-group difference in duration of endotracheal intubation , although in the PW group , after removal of the tracheal cannula , duration of noninvasive positive pressure ventilation was significantly longer in older patients .
CONCLUSIONS	The pericardial window procedure did not increase the rate or severity of procedure-related complications .
CONCLUSIONS	This simple technique significantly decreased the incidence of postoperative pericardial tamponade and new-onset atrial fibrillation .

###24280466
OBJECTIVE	To evaluate the efficacy of comprehensive interventions based on the three TCM patterns on symptoms and quality of life of COPD patients .
METHODS	An open-label , randomized , controlled trial .
METHODS	Four hospitals in China .
METHODS	352 patients were randomly divided into two groups .
METHODS	Patients in the trial group were given conventional Western medicine and Bu-Fei Jian-Pi granules , Bu-Fei Yi-Shen granules and Yi-Qi Zi-Shen granules respectively ; patients in the control group were given conventional Western medicine .
METHODS	Data collection was performed at baseline , in the 3rd and 6th month during the treatment period , and the 12th month during the follow-up period .
RESULTS	Symptoms , including cough , sputum , pant , chest tightness , short of breath , lassitude , cyanosis and symptom total score ; quality of life , measured by the WHOQOL-BREF questionnaire and adult COPD quality of life questionnaire ( COPD-QOL ) .
RESULTS	Of the 352 patients , 306 fully completed the study .
RESULTS	After treatment and follow-up , there were significant differences between two groups in the following : cough , sputum , pant , chest tightness , shortness of breath , lassitude score and symptom total score ( P < .05 ) ; physical , psychological , social and environment domain ( P < .05 ) of the WHOQOL-BREF ; daily living ability , social activity , depression symptoms and anxiety symptoms domain ( P < .05 ) of the COPD-QOL .
RESULTS	There were no differences between two groups in cyanosis and adverse events .
CONCLUSIONS	Based on the TCM patterns , Bu-Fei Jian-Pi granules , Bu-Fei Yi-Shen granules and Yi-Qi Zi-Shen granules have beneficial effects on symptoms and quality of life of COPD patients .

###25755211
BACKGROUND	Nelarabine has shown impressive single agent clinical activity in T-cell acute lymphoblastic leukemia ( T-ALL ) , but has been associated with significant neurotoxicities in heavily pre-treated patients .
BACKGROUND	We showed previously that it was safe to add nelarabine to a BFM-86 chemotherapy backbone ( AALL00P2 ) .
BACKGROUND	Children 's Oncology Group ( COG ) AALL0434 is a Phase III study designed to test the safety and efficacy of nelarabine when incorporated into a COG augmented BFM-based regimen , which increases exposure to agents with potential neurotoxicity compared to the historical AALL00P2 regimen .
METHODS	AALL0434 included a safety phase to assess nelarabine toxicity .
METHODS	Patients with high-risk ( HR ) T-ALL were randomized to receive Capizzi-style escalating methotrexate ( MTX ) plus pegaspargase or high dose ( HD ) MTX with/without six five-days courses of nelarabine .
METHODS	We report results from 94 patients who participated in the initial safety phase of the study .
RESULTS	There were no differences in the incidence of peripheral motor neuropathies , sensory neuropathies or central neurotoxicities among those randomized to the nelarabine ( n = 47 ) and non-nelarabine arms ( n = 47 ) .
CONCLUSIONS	The addition of nelarabine to COG-augmented BFM chemotherapy regimen is safe and feasible .
CONCLUSIONS	The ongoing AALL0434 Efficacy Phase will determine whether the addition of nelarabine treatment improves outcome for patients with T-ALL .

###24528246
BACKGROUND	In a previous single-center , open-label randomized 3-month study of triple oral antidiabetes drug ( OAD ) therapy , we investigated factors affecting the glycemic control afforded by sitagliptin , high-dose metformin , and low-dose glimepiride .
BACKGROUND	Patients were prospectively assigned to either Group 1 ( 50 % reduction in metformin ) or Group 2 ( discontinuation of glimepiride ) and compared .
BACKGROUND	The results showed that the glycated hemoglobin ( HbA1c ) levels of patients in Group 2 deteriorated more than those in Group 1 , whereas HbA1c levels were maintained in some patients in both groups .
METHODS	To determine the factors associated with maintenance of HbA1c under this triple OAD regimen , data from the prospective study were further analyzed .
RESULTS	In both Groups 1 and 2 , the baseline HbA1c level was higher in patients with HbA1c 7.0 % after 3 months of treatment than those with an HbA1c level of < 7.0 % .
RESULTS	A generalized linear model revealed that high-dose metformin was associated with a deterioration of HbA1c levels in Group 2 .
CONCLUSIONS	Together , the findings indicate that glimepiride and high-dose metformin are important for sustained glycemic control in triple OAD therapy with sitagliptin , metformin , and sulfonylurea .

###25195982
OBJECTIVE	Conduct of emergency research under waiver of consent produces special challenges .
OBJECTIVE	Moreover , the act of performing research may have unintended effects , potentially beneficial or detrimental .
OBJECTIVE	The Dispatcher-Assisted Randomized Trial ( DART ) was designed to compare 2 types of dispatcher cardiopulmonary ( CPR ) instruction , but not intended to affect the proportion of arrest victims that received bystander CPR .
OBJECTIVE	We sought to determine whether odds of receiving bystander CPR were higher during DART than during the periods before and after .
METHODS	We conducted an observational cohort study of 8626 adults who suffered non-traumatic out-of-hospital cardiac arrest prior to emergency medical services ( EMS ) arrival in greater King County , Washington , between January 1 , 1999 , and December 31 , 2011 .
METHODS	Bystander CPR status was assessed through review of dispatch recordings and EMS reports to classify any bystander CPR ( any B-CPR ) , and further categorized as bystander CPR with or without dispatcher assistance ( DA-CPR and B-CPR , no DA ) .
METHODS	We used multivariable logistic regression to evaluate odds of B-CPR before , during , and after DART .
RESULTS	The proportions receiving any B-CPR were 52 % before DART ( 1817/3468 ) , 59 % during DART ( 2093/3527 ) , and 54 % after DART ( 885/1631 ) .
RESULTS	Compared to the period before DART , odds of receiving any B-CPR were higher during DART ( OR = 1.35 , 95 % CI = 1.23-1 .49 ) , but no different after ( OR = 1.10 , 0.98-1 .24 ) .
RESULTS	Compared to the before period , odds of DA-CPR were higher during DART ( OR = 1.79 , 1.59-2 .02 ) but no different after ( OR = 0.94 , 0.80-1 .10 ) .
CONCLUSIONS	Odds of bystander CPR were higher during the trial , an increase related to higher likelihood of DA-CPR .
CONCLUSIONS	The finding suggests a possible indirect community-wide benefit due to the interventional trial .

###25112584
BACKGROUND	Opioid-induced constipation ( OIC ) is a common adverse effect of opioid therapy .
OBJECTIVE	To evaluate the long-term safety and tolerability of naloxegol , an oral , peripherally acting - opioid receptor antagonist ( PAMORA ) , in patients with noncancer pain and OIC .
METHODS	A 52-week , multicenter , open-label , randomised , parallel-group phase 3 study was conducted in out-patients taking 30-1000 morphine-equivalent units per day for 4 weeks .
METHODS	Patients were randomised 2:1 to receive naloxegol 25 mg/day or usual-care ( UC ; investigator-chosen laxative regimen ) treatment for OIC .
RESULTS	The safety set comprised 804 patients ( naloxegol , n = 534 ; UC , n = 270 ) .
RESULTS	Mean exposure duration was 268 days with naloxegol and 297 days with UC .
RESULTS	Frequency of adverse events ( AEs ) was 81.8 % with naloxegol and 72.2 % with UC .
RESULTS	Treatment-emergent AEs occurring more frequently for naloxegol vs. UC were abdominal pain ( 17.8 % vs. 3.3 % ) , diarrhoea ( 12.9 % vs. 5.9 % ) , nausea ( 9.4 % vs. 4.1 % ) , headache ( 9.0 % vs. 4.8 % ) , flatulence ( 6.9 % vs. 1.1 % ) and upper abdominal pain ( 5.1 % vs. 1.1 % ) .
RESULTS	Most naloxegol-emergent gastrointestinal AEs occurred early , resolving during or after naloxegol discontinuation and were mild or moderate in severity ; 11 patients discontinued due to diarrhoea and nine patients owing to abdominal pain .
RESULTS	Pain scores and mean daily opioid doses remained stable throughout the study ; no attributable opioid withdrawal AEs were observed .
RESULTS	Two patients in each group had an adjudicated major adverse cardiovascular event unrelated to study drug ; no AEs were reported nor adjudicated as bowel perforations .
CONCLUSIONS	In patients with noncancer pain and opioid-induced constipation , naloxegol 25 mg/day up to 52 weeks was generally safe and well tolerated .

###24867688
BACKGROUND	Screening for prostate cancer continues to generate controversy because of concerns about over-diagnosis and unnecessary treatment .
BACKGROUND	We describe the rationale , design and recruitment of the Cluster randomised triAl of PSA testing for Prostate cancer ( CAP ) trial , a UK-wide cluster randomised controlled trial investigating the effectiveness and cost-effectiveness of prostate-specific antigen ( PSA ) testing .
METHODS	Seven hundred and eighty-five general practitioner ( GP ) practices in England and Wales were randomised to a population-based PSA testing or standard care and then approached for consent to participate .
METHODS	In the intervention arm , men aged 50-69 years were invited to undergo PSA testing , and those diagnosed with localised prostate cancer were invited into a treatment trial .
METHODS	Control arm practices undertook standard UK management .
METHODS	All men were flagged with the Health and Social Care Information Centre for deaths and cancer registrations .
METHODS	The primary outcome is prostate cancer mortality at a median 10-year-follow-up .
RESULTS	Among randomised practices , 271 ( 68 % ) in the intervention arm ( 198,114 men ) and 302 ( 78 % ) in the control arm ( 221,929 men ) consented to participate , meeting pre-specified power requirements .
RESULTS	There was little evidence of differences between trial arms in measured baseline characteristics of the consenting GP practices ( or men within those practices ) .
CONCLUSIONS	The CAP trial successfully met its recruitment targets and will make an important contribution to international understanding of PSA-based prostate cancer screening .

###25022114
OBJECTIVE	To verify the clinical efficacy of acupuncture combined with auricle cutting method for treatment of blood stasis-type psoriasis .
METHODS	Fifty-six cases of blood stasis-type psoriasis were randomly divided into a combined therapy group , a auricle cutting group , an acupuncture group and a control group , 14 cases in each one .
METHODS	Based on regular treatment of TCM decoction in four groups , the combined therapy group was treated with acupuncture and auricle cutting method , and the auricle cutting group was treated with sham-acupuncture and auricle cutting , and the acupuncture group was treated with acupuncture and sham auricle cutting , and the control group was treated with sham-acupuncture and sham auricle cutting .
METHODS	The acupuncture was applied at Dazhui ( GV 14 ) , Feishu ( BL 13 ) , Ganshu ( BL 18 ) and Geshu ( BL 17 ) , etc. , and manipulated with routine technique ; in the sham acupuncture , the needle was inserted into dermis layer so that the needles could be swung without being dropped out .
METHODS	In the auricle cutting , erbeixin ( P1 ) of unilateral auricle was selected and cut by Chan needle to perform bloodletting ; in the sham auricle cutting , the neighborhood approximately 0.5 cm next to erbeixin ( P ) of auricle was selected as cutting area .
METHODS	The treatment was given once a day , seven days as a treatment session for totally two sessions .
METHODS	Psoriasis area and severity index ( PASI ) before and after treatment was observed and efficacy of each group was compared .
RESULTS	The effective rate was 57.1 % ( 8/14 ) in the combined therapy group , which was superior to 14.3 % ( 2/14 ) in the auricle cutting group , 7.1 % ( 1/14 ) in the acupuncture group and 0.0 % ( 0/14 ) in the control group ( all P < 0.05 ) .
RESULTS	The scores of PASI were all decreased in each group after the treatment ( all P < 0.05 ) , which was the most significant in the combined therapy group ( all P < 0.05 ) .
RESULTS	After factorial analysis , the main effect was P < 0.05 in the auricle cutting , P < 0.05 in the acupuncture and P < 0.05 in interaction effect of combined therapy .
CONCLUSIONS	The scores of PASI of blood stasis-type psoriasis could be effectively reduced by acupuncture , auricle cutting method and TCM decoction , among which the interaction effect of auricle cutting and acupuncture combined with TCM decoction is the most significant .

###25246421
BACKGROUND	The deep-fried Mars bar has been cited as ` all that is wrong with the high-fat , high-sugar Scottish diet ' .
BACKGROUND	We investigated the effect of ingestion of a deep-fried Mars bar or porridge on cerebrovascular reactivity .
BACKGROUND	We hypothesised that deep-fried Mars bar ingestion would impair cerebrovascular reactivity , which is associated with increased risk of ischaemic stroke .
METHODS	Twenty-four fasted volunteers were randomised to receive a deep-fried Mars bar and then porridge ( control ) , or vice-versa .
METHODS	We used transcranial Doppler ultrasound to calculate Breath Holding Index as a surrogate measure of cerebrovascular reactivity .
METHODS	Change in Breath Holding Index post-ingestion was the primary outcome measure .
RESULTS	Twenty-four healthy adults ( mean ( SD ) age 21.5 ( 1.7 ) years , 14 males ) completed the protocol .
RESULTS	Deep-fried Mars bar ingestion caused a non-significant reduction in cerebrovascular reactivity relative to control ( mean difference in absolute Breath Holding Index after deep-fried Mars bar versus porridge -0.11 , p = 0.40 ) .
RESULTS	Comparison of the difference between the absolute change in Breath Holding Index between genders demonstrated a significant impairment of cerebrovascular reactivity in males ( mean difference women minus men of 0.65 , 95 % CI 0.30 to 1.00 , p = 0.0003 ) .
CONCLUSIONS	Ingestion of a bolus of sugar and fat caused no overall difference in cerebrovascular reactivity , but there was a modest decrease in males .
CONCLUSIONS	Impaired cerebrovascular reactivity is associated with increased stroke risk , and therefore deep-fried Mars bar ingestion may acutely contribute to cerebral hypoperfusion in men .

###25708147
OBJECTIVE	To evaluate changes in salivary gland echostructure and vascularization after rituximab treatment in patients with primary Sjgren 's syndrome ( SS ) .
METHODS	Twenty-eight patients with primary SS included in the multicenter , randomized , double-blind , placebo-controlled Tolerance and Efficacy of Rituximab in Primary Sjgren 's Syndrome ( TEARS ) trial underwent salivary gland ultrasonography before the first placebo or rituximab infusion and then 6 months later .
METHODS	Trial inclusion criteria were scores of 50 mm on at least 2 of 4 visual analog scales ( VAS ) evaluating dryness , pain , fatigue , and global disease ; and recent-onset ( < 10 years ) biologically active primary SS and/or systemic primary SS .
METHODS	Patients were randomly assigned ( 1:1 ) to rituximab ( 1 gm at weeks 0 and 2 ) or placebo .
METHODS	Ultrasonography of both parotid and submandibular glands was performed to assess echostructure ( using a semiquantitative score of 0-4 , with improvement defined as a 1-point decrease ) , size of each gland , and vascularization based on the resistive index of the transverse facial artery of the parotid gland before and after lemon juice stimulation .
RESULTS	Of the 28 patients , 5 ( 18 % ; 3 in the placebo group and 2 in the rituximab group ) had clinically detectable bilateral parotid gland enlargement at baseline .
RESULTS	Parotid parenchyma echostructure improved in 50 % of the rituximab-treated patients versus 7 % of the placebo-treated patients ( P = 0.03 ) .
RESULTS	In the submandibular glands , echostructure also improved in a larger proportion of rituximab-treated patients , although the difference was not significant ( 36 % versus 7 % of placebo-treated patients ; P = 0.16 ) .
RESULTS	Gland sizes and resistive index remained unchanged .
CONCLUSIONS	Ultrasonography showed improved salivary gland echostructure in patients with primary SS receiving rituximab , with no changes in salivary gland size or vascularization , 6 months after the first infusion .

###25850706
OBJECTIVE	The aim of this study was to describe the aims , methods , donor and recipient cohort characteristics , and potential impact of the Cornea Preservation Time Study ( CPTS ) .
METHODS	The CPTS is a randomized clinical trial conducted at 40 clinical sites ( 70 surgeons ) designed to assess the effect of donor cornea preservation time ( PT ) on graft survival 3 years after Descemet stripping automated endothelial keratoplasty ( DSAEK ) .
METHODS	Eyes undergoing surgery for Fuchs endothelial corneal dystrophy or pseudophakic/aphakic corneal edema were randomized to receive donor corneas stored 7 days or 8 to 14 days .
METHODS	Donor and patient characteristics , tissue preparation and surgical parameters , recipient and donor corneal stroma clarity , central corneal thickness , intraocular pressure , complications , and a reading center-determined central endothelial cell density were collected .
METHODS	Surveys were conducted to evaluate pre-CPTS PT practices .
RESULTS	The 1330 CPTS donors were : 49 % > 60 years old , 27 % diabetic , had a median eye bank-determined screening endothelial cell density of 2688 cells/mm , and 74 % eye bank prepared for DSAEK .
RESULTS	A total of 1090 recipients ( 1330 eyes including 240 bilateral cases ) had : median age of 70 years , were 60 % female , 90 % white , 18 % diabetic , 52 % phakic , and 94 % had Fuchs endothelial corneal dystrophy .
RESULTS	Before the CPTS , 19 eye banks provided PT data on 20,852 corneas domestically placed for DSAEK in 2010 to 2011 ; 96 % were preserved 7 days .
RESULTS	Of 305 American Academy of Ophthalmology members responding to a pre-CPTS survey , 233 ( 76 % ) set their maximum PT preference at 8 days or less .
CONCLUSIONS	The CPTS will increase understanding of factors related to DSAEK success and , if noninferiority of longer PT is shown , will have great potential to extend the available pool of endothelial keratoplasty donors.Clinical Trial Registration-URL : http://www.clinicaltrials.gov .
CONCLUSIONS	Unique identifier : NCT01537393 .

###24560173
OBJECTIVE	The aim of the present study was to evaluate the periodontal regenerative capacity of demineralized freeze-dried bone allograft ( DFDBA ) alone or used with local lincomycin .
METHODS	In the present single-blind , randomized , controlled clinical trial , 20 subjects 26 years old or older , requiring extraction of bilateral third molars ( M3s ) , were included .
METHODS	Each subject was randomly assigned to receive either DFDBA or DFDBA plus lincomycin therapy .
METHODS	Within the subjects , 1 M3 site was randomly selected to be the experimental site and the contralateral served as the control and was permitted to heal without intervention .
METHODS	The primary variables were changes in the probing depth ( PD ) , clinical alveolar bone levels ( ABLs ) , and radiographic alveolar bone density ( ABD ) on the distal aspect of second molar between baseline ( immediately postoperatively ) and 26 weeks postoperatively ( T26 ) .
METHODS	Appropriate sample sizes and descriptive , bivariate , and multivariate statistics were computed .
RESULTS	For both treatment and control sites , between T0 and T26 , statistically significant improvements were seen in the ABLs and ABD ( P < .05 ) .
RESULTS	Within-subject comparisons showed no significant differences in PD , ABL , or ABD between the treatment and control M3 sites at T0 or T26 ( P > .05 ) .
RESULTS	Also , no significant differences were found in the PD , ABL , or ABD between the 2 treatment M3 sites at T26 ( P > .05 ) .
CONCLUSIONS	The results of the present study have revealed that the PD , ABL , and ABD improved after M3 removal in subjects 26 years old or older , irrespective of the treatment or control group .
CONCLUSIONS	Reconstructive procedures ( e.g. , DFDBA with or without lincomycin therapy ) did not offer predictable benefits compared with a no-treatment protocol in patients younger than 30 years old .

###25795059
OBJECTIVE	To compare outcomes of phaco-canaloplasty ( PC ) and phaco-non-penetrating deep sclerectomy ( PDS ) with a viscoelastic compound .
METHODS	This study included 29 eyes after PC and 30 after PDS .
METHODS	Indications were uncontrolled primary open-angle glaucoma ( POAG ) and a cataract .
METHODS	Corrected distance visual acuity ( CDVA ) , intraocular pressure ( IOP ) , and number of medications were evaluated .
METHODS	Follow-up examinations were performed on days 1 and 7 , and after 1 , 3 , 6 , and 12 months .
METHODS	Complete and qualified success was an IOP 18 mmHg .
RESULTS	At the 12-month follow-up , mean IOP decreased in the PC group from 19.06.9 mmHg to 12.62.7 mmHg , and in the PDS group , from 19.15.8 mmHg to 14.33.5 mmHg ( P < 0.05 ) .
RESULTS	Both groups preoperatively and at 12 months showed no significant differences in IOP ( P > 0.05 ) .
RESULTS	There was no statistically significant difference between the number of medications used ( P > 0.05 ) .
RESULTS	Complete and qualified success rates for both groups were 79.0 % and 76.9 % ( P = 0.701 ) .
RESULTS	The most frequent postoperative PC complication was hyphema ( 58.0 % ) ; for PDS , bleb fibrosis was most frequent ( 26.7 % ) .
RESULTS	No PC patients required postoperative management .
RESULTS	PDS patients required postoperative interventions 58.7 % of the time , including a 5-fluorouracil ( 5-FU ) injection ( 58.7 % ) , suture lysis ( 48.3 % ) , and needling ( 27.6 % ) .
CONCLUSIONS	Both PC and PDS lead to an effective decrease in IOP on a short-term follow-up basis and demonstrate similar efficacy and safety profiles .
CONCLUSIONS	PDS patients required additional procedures including 5-FU injections , suture lysis , or needling .
CONCLUSIONS	PC patients required no additional procedures .

###24528528
BACKGROUND	Type 2 diabetes ( T2D ) brings significant human and healthcare costs .
BACKGROUND	Its progressive nature means achieving normoglycaemia is increasingly difficult , yet critical to avoiding long term vascular complications .
BACKGROUND	Nearly one-half of people with T2D have glycaemic levels out of target .
BACKGROUND	Insulin is effective in achieving glycaemic targets , yet initiation of insulin is often delayed , particularly in primary care .
BACKGROUND	Given limited access to specialist resources and the size of the diabetes epidemic , primary care is where insulin initiation must become part of routine practice .
BACKGROUND	This would also support integrated holistic care for people with diabetes .
BACKGROUND	Our Stepping Up Program is based on a general practitioner ( GP ) and practice nurse ( PN ) model of care supported appropriately by endocrinologists and credentialed diabetes educator-registered nurses .
BACKGROUND	Pilot work suggests the model facilitates integration of the technical work of insulin initiation within ongoing generalist care .
METHODS	This protocol is for a cluster randomized controlled trial to examine the effectiveness of the Stepping Up Program to enhance the role of the GP-PN team in initiating insulin and improving glycaemic outcomes for people with T2D .
METHODS	224 patients between the ages of 18 and 80 years with T2D , on two or more oral hypoglycaemic agents and with an HbA1c 7.5 % in the last six months will be recruited from 74 general practices .
METHODS	The unit of randomization is the practice.Primary outcome is change in glycated haemoglobin HbA1c ( measured as a continuous variable ) .
METHODS	We hypothesize that the intervention arm will achieve an absolute HbA1c mean difference of 0.5 % lower than control group at 12 months follow up .
METHODS	Secondary outcomes include the number of participants who successfully transfer to insulin and the proportion who achieve HbA1c measurement of < 7.0 % .
METHODS	We will also collect data on patient psychosocial outcomes and healthcare utilization and costs .
CONCLUSIONS	The study is a pragmatic translational study with important potential implications for people with T2D , healthcare professionals and funders of healthcare though making better use of scarce healthcare resources , improving timely access to therapy that can improve disease outcomes .
BACKGROUND	Australian and New Zealand Clinical Trials Registry ACTRN12612001028897 .

###24501384
BACKGROUND	Probiotics have a possible role in the treatment of pediatric acute gastroenteritis .
BACKGROUND	We report the effect of the probiotic Lactobacillus rhamnosus GG ( LGG ) on intestinal function , immune response , and clinical outcomes in Indian children with cryptosporidial or rotavirus diarrhea .
METHODS	Children with gastroenteritis aged 6 months to 5 years , testing positive for either rotavirus or Cryptosporidium species in stool ( coinfections were excluded ) , were randomized to LGG ( ATCC 53103 ) or placebo , once daily for 4 weeks .
METHODS	Baseline demographic and clinical details were obtained .
METHODS	Sera were tested for immunoglobulin G ( IgG ) and immunoglobulin A ( IgA ) antibodies to Cryptosporidium and rotavirus , and the lactulose to mannitol ratio for intestinal permeability was determined at baseline and at the end of follow-up .
RESULTS	Of the 124 children enrolled , 82 and 42 had rotavirus and cryptosporidial diarrhea , respectively .
RESULTS	Median diarrheal duration was 4 days ; one-third of the children had severe diarrhea .
RESULTS	Baseline and clinical parameters were comparable between children receiving LGG and placebo .
RESULTS	At the end of follow-up , fewer children with rotavirus diarrhea on LGG had repeated diarrheal episodes ( 25 % vs 46 % ; P = .048 ) and impaired intestinal function ( 48 % vs 72 % ; P = .027 ) .
RESULTS	Significant increase in IgG levels postintervention ( 456 vs 2215 EU ; P = .003 ) was observed in children with rotavirus diarrhea receiving LGG .
RESULTS	Among children with cryptosporidial diarrhea , those receiving LGG showed significant improvement in intestinal permeability .
CONCLUSIONS	LGG has a positive immunomodulatory effect and may be useful in decreasing repeated episodes of rotavirus diarrhea .
CONCLUSIONS	Improvement in intestinal function in children with rotavirus and cryptosporidial gastroenteritis emphasizes the role of probiotics in treating intestinal impairment after infection .
BACKGROUND	CTRI/2010/091 / 000339 .

###24353022
OBJECTIVE	Arthroscopic shoulder surgery can result in substantial postoperative pain .
OBJECTIVE	This study evaluated the efficacy and safety of tapentadol immediate release ( IR ) or oxycodone IR in this setting for the treatment of acute pain .
METHODS	Subjects received tapentadol IR 50 or 100 mg or oxycodone IR 5 or 10 mg every 4-6 hours as needed for pain up to 7 days after arthroscopic shoulder surgery .
METHODS	Twice daily , subjects recorded pain intensity from 0 ( no pain ) to 10 ( pain as bad as you can imagine ) and pain relief from 0 ( none ) to 5 ( complete ) .
METHODS	Final assessments included patient and clinician global impression of change and subject satisfaction with treatment .
METHODS	The primary efficacy endpoint was the sum of pain intensity differences ( SPID ) over 3 days .
RESULTS	Of 378 subjects ( 192 tapentadol IR , 186 oxycodone IR ) who took study medication , 312 ( 158 tapentadol IR , 154 oxycodone IR ) had pain intensity 4 before the first dose and were evaluated for efficacy .
RESULTS	Mean SPID scores over 3 days were 32.1 and 41.1 in the tapentadol IR and oxycodone IR groups , respectively ( least-squares mean difference [ 95 % confidence interval ] , 9.0 [ -18.9 , 36.9 ] ; p = 0.527 ) .
RESULTS	Secondary analyses of pain intensity , pain relief , and subject satisfaction were similar between groups .
RESULTS	Subjects and clinicians reported significantly better global impression of change for tapentadol IR .
RESULTS	Adverse events were consistent with established safety profiles for IR opioids .
CONCLUSIONS	Tapentadol IR and oxycodone IR had similar efficacy for pain after arthroscopic shoulder surgery , but subjects and clinicians reported greater overall improvement with tapentadol IR .

###24313543
BACKGROUND	Dietary modification may be important in the prevention and control of chronic adult periodontitis .
BACKGROUND	The role of promoting an adequate consumption of fruits , vegetables and whole grains in chronic periodontitis has not been thoroughly investigated .
BACKGROUND	The main aim of this dietary intervention study was to assess the influence of a customised dietary intervention ( aiming to increase the consumption of fruits , vegetables and whole grains ) on antioxidant status in adults with chronic periodontitis .
METHODS	Fifty-one participants , aged 30-65 years , were recruited from a U.K. Dental Hospital and randomly allocated to an intervention or control group .
METHODS	Both groups received normal clinical treatment but customised dietary advice was delivered to the intervention group by a community nutrition assistant .
METHODS	Dietary intakes , anthropometric parameters and biochemical indices with respect to blood and saliva and periodontal indices were evaluated at baseline , as well as at 3 and 6 months post-dietary intervention .
RESULTS	At 3 and 6 months post-intervention , the intervention group showed a significant ( P < 0.05 ) increase in plasma total antioxidant capacity measured by Trolox equivalent antioxidant capacity assay compared to the control group .
RESULTS	At 3 and 6 months after dietary intervention , the intervention group had significantly higher intakes of fruits and vegetables compared to the control group .
RESULTS	The intake of whole grain was significantly higher in the intervention group than in the control group , 6 months post-intervention .
RESULTS	No significant differences were observed with respect to periodontal indices between groups .
CONCLUSIONS	It is suggested that dietary advice may help to improve dietary habits and , consequently , the antioxidant status of patients with chronic periodontitis .
CONCLUSIONS	However , the impact of such intervention on periodontal indices needs further investigation .

###24361787
OBJECTIVE	The purpose of this study was to explore in greater depth the outcomes of the Italian randomized trial investigating the role of pelvic lymphadenectomy in clinical early stage endometrial cancer .
OBJECTIVE	In the attempt to identify the patients with poorer prognosis , the impact of age and body mass index were also thoroughly investigated by cancer-specific survival ( CSS ) analyses .
METHODS	Survival outcomes of trial patients were analyzed in relation to age ( 65 years and > 65 years ) in the 2 arms ( lymphadenectomy and no lymphadenectomy ) and in the whole population of the trial .
RESULTS	Univariate and multivariable analyses of CSS and overall survival ( OS ) of patients showed that age > 65 years is a strong independent poor prognostic factor ( 5-y OS 92.1 % and 78.4 % in 65 years and > 65 years patients , respectively , P < .0001 ; 5-y CSS 93.8 % and 83.5 % in 65 years and > 65 years patients , respectively , P = .003 ) .
RESULTS	Among women 65 years , node negative patients had 94.4 % 5-y OS and 96.3 % 5-y CSS vs 74.3 % 5-y OS and 74.3 % 5-y CSS for node positive patients ( P = .009 and P = .002 , respectively ) , while among women > 65 y , node negative patients had 75.7 % 5-y OS and 83.6 % 5-y CSS vs 74.1 % 5-y OS and 83.3 % 5-y CSS for node positive patients ( P = .55 and P = .58 , respectively ) .
RESULTS	Univariate and multivariable survival analyses in the whole trial population showed that older age , and higher tumor grade and stage were significantly associated to a worse prognosis .
CONCLUSIONS	Older women faced an intrinsic poorer survival whether or not they underwent lymphadenectomy , and , unexpectedly , irrespective of the presence of nodal metastasis .
CONCLUSIONS	Only in older patients was obesity ( body mass index > 30 ) significantly associated with scarce prognosis .

###25214775
BACKGROUND	Treatment decisions for older patients with type 2 diabetes mellitus must balance glycemic control and adverse event risk .
BACKGROUND	The objective of this study was to evaluate the long-term safety and tolerability of saxagliptin 5 mg as add-on therapy to common antihyperglycemic drugs in patients aged 65 years and < 65 years .
METHODS	Pooled adverse event data from three placebo-controlled trials of 76-206 weeks ' duration in older ( 65 years ) and younger ( < 65 years ) patients receiving saxagliptin 5 mg or matching placebo added to metformin , glyburide , or a thiazolidinedione were analyzed .
METHODS	Measurements were calculated from day of first dose to specified event or last dose and included time at risk for adverse events , treatment-related adverse events , serious adverse events , adverse events leading to discontinuation , and events of special interest .
METHODS	Weighted incidence rates ( number of events/total time ) and incidence rate ratios ( saxagliptin/placebo ) with 95 % confidence intervals were calculated ( Mantel-Haenszel test ) .
RESULTS	A total of 205 older ( mean age 69 years ; saxagliptin , n = 99 ; placebo , n = 106 ) and 1,055 younger ( mean age 52 years ; saxagliptin , n = 531 ; placebo , n = 524 ) patients were assessed .
RESULTS	Regardless of age category , the adverse event incidence rates were generally similar between treatments , with confidence intervals for incidence rate ratios bridging 1 .
RESULTS	Treatment-related adverse events occurred in 36 older patients receiving saxagliptin versus 32 receiving placebo ( incidence rate 34.1 versus 27.1 per 100 person-years ) and in 150 younger patients in both treatment groups ( incidence rate 24.0 versus 27.8 per 100 person-years ) .
RESULTS	With saxagliptin versus placebo , serious adverse events occurred in eight versus 14 older ( incidence rate 5.7 versus 9.9 per 100 person-years ) and 49 versus 44 younger patients ( incidence rate 6.5 versus 6.6 per 100 person-years ) .
RESULTS	There were two deaths ( one patient 65 years ) with saxagliptin and six ( none aged 65 years ) with placebo .
RESULTS	Older patients rarely experienced symptomatic confirmed hypoglycemia ( fingerstick glucose 50 mg/dL ; saxagliptin , n = 1 ; placebo , n = 2 ) .
CONCLUSIONS	Saxagliptin add-on therapy was generally well tolerated in older patients aged 65 years with type 2 diabetes mellitus , with a long-term safety profile similar to that of placebo .

###25451321
OBJECTIVE	Genetic knockout or pharmacological inhibition of the beta-2 adrenergic receptor ( B2AR ) increased bone mass , whereas stimulation decreased bone mass in rodents .
OBJECTIVE	In humans , observational studies support sympathetic nervous system regulation of bone metabolism , but intervention studies are lacking .
OBJECTIVE	We aimed to determine the effects of a selective beta-2 adrenergic agonist and non-selective antagonist on human bone metabolism .
METHODS	32 healthy postmenopausal women were included in a randomized controlled trial conducted in the Academic Medical Center Amsterdam .
METHODS	Participants were randomized to receive treatment with 17 - estradiol 2mg/day ; 17 - estradiol 2mg/day and terbutaline 5mg/day ( selective B2AR agonist ) ; propranolol 80mg/day ( non-selective B-AR antagonist ) ; or no treatment during 12weeks .
METHODS	Main outcome measure was the change in serum concentrations of procollagen type I N propeptide ( P1NP ) and C-terminal crosslinking telopeptides of collagen type I ( CTx ) as markers of bone formation and resorption after 12weeks compared between the treatment groups .
METHODS	Data were analyzed with mixed model analysis .
RESULTS	17 - estradiol decreased bone turnover compared to control ( P1NP p < 0.001 , CTx p = 0.003 ) , but terbutaline combined with 17 - estradiol failed to increase bone turnover compared to 17 - estradiol alone ( P1NP p = 0.135 , CTx p = 0.406 ) .
RESULTS	Propranolol did not affect bone turnover compared to control ( P1NP p = 0.709 , CTx p = 0.981 ) .
CONCLUSIONS	Selective beta-2 adrenergic agonists and non-selective beta-antagonists do not affect human bone turnover although we can not exclude small changes below the detection limit of this study .

###24811326
BACKGROUND	The Personal Calorie Monitor ( PCM ) is a portable direct calorimeter that estimates energy expenditure ( EE ) from measured heat flux ( i.e. , the sum of conductive , convective , radiative , and evaporative heat ) .
OBJECTIVE	The primary aim of this study was to compare EE estimated from measures of heat flux with those measured using indirect calorimetry in a thermoneutral environment ( 26C ) .
OBJECTIVE	A secondary aim was to determine whether exposure to ambient temperature below thermoneutral condition ( 19C ) influences the accuracy of the PCM .
METHODS	Thirty-four adults ( mean SD : age , 28 5 yr ; body mass index , 22.9 2.6 kg m ( -2 ) ) were studied for 5 h in a whole-room indirect calorimeter ( IC ) in thermoneutral and cool conditions .
METHODS	Participants wore the PCM on their upper arm and completed two 20-min treadmill walking bouts ( 0 % grade , 3 mph ) .
METHODS	The remaining time was spent sedentary ( e.g. , watching television , using a computer ) .
RESULTS	In thermoneutral conditions , EE values ( mean ( 95 % confidence interval ) ) measured by IC and PCM were 560.0 ( 526.5-593 .5 ) and 623.3 ( 535.5-711 .1 ) kcal , respectively .
RESULTS	In cool conditions , EE values measured by IC and PCM were 572.5 ( 540.9-604 .0 ) and 745.5 ( 668.1-822 .8 ) kcal , respectively .
RESULTS	Under thermoneutral conditions , mean PCM minute-by-minute EE tracked closely with IC , resulting in a small nonsignificant bias ( 63 kcal ( -5.8 to 132.4 ) ) .
RESULTS	During cool conditions , mean PCM minute-by-minute EE did not track IC , resulting in a large bias ( 173.0 kcal ( 93.9-252 .1 ) ) ( P < ; 0.001 ) .
CONCLUSIONS	This study demonstrated the validity of using measured heat flux to estimate EE .
CONCLUSIONS	However , accuracy may be impaired in cool conditions possibly because of excess heat loss from the exposed limbs .

###24444992
OBJECTIVE	To determine the accuracy and precision of simultaneous noninvasive blood pressure ( NIBP ) measurement in the arm , forearm , and ankle in anesthetized children .
METHODS	Prospective , randomized study .
METHODS	University medical center .
METHODS	101 ASA physical status 1 and 2 children ( aged 1-8 yrs ) scheduled for elective surgery with general anesthesia .
METHODS	Simultaneous NIBP measurements were recorded at the arm , forearm , and ankle at 5-minute intervals .
RESULTS	The systolic blood pressure difference between the arm-forearm or the arm-ankle was within the 10 % range in 63 % and 29 % of measurements , and within the 20 % range in 85 % and 67 % of measurements , respectively .
RESULTS	The diastolic blood pressure difference between the arm-forearm or the arm-ankle was within the 10 % range in 42 % and 44 % and within the 20 % range in 67 % and 74 % of measurements , respectively .
RESULTS	In patients in whom the initial three NIBP measurements were within the 20 % range between the forearm and arm , 86 % of the subsequent measurements were also within that limit .
CONCLUSIONS	Forearm and ankle NIBP measurements are unreliable and inconsistent with NIBP measured in the arm of anesthetized children .
CONCLUSIONS	These alternative BP measurement sites are not reliable in accuracy ( comparison with reference `` gold '' standard ) and precision ( reproducibility ) .

###24863677
OBJECTIVE	To assess health-related quality of life ( QoL ) and clinical factors predicting it after tonsillectomy among adult patients with recurrent pharyngitis .
METHODS	Prospective cohort design .
METHODS	Tertiary referral centre .
METHODS	Adults ( n = 153 ) who underwent tonsillectomy for recurrent pharyngitis .
METHODS	QoL 6 months after tonsillectomy measured by the Glasgow Benefit Inventory ( GBI ) .
METHODS	Factors predicting high postoperative QoL were sought using multiple linear regression analysis .
RESULTS	Of the 142 patients ( 93 % of all eligible ) responding to the GBI questionnaire , 94 ( 66 % ) were female ; median age was 26 years ( range 14-65 ) .
RESULTS	GBI Total Scores varied markedly ( range -19 to +69 ) , but on average showed improvement ( median +27 , interquartile range 18-36 ) , most evidently in the GBI Physical Health Score ( median +83 ) , after tonsillectomy .
RESULTS	Among routinely recorded clinical characteristics , the number of prior pharyngitis episodes , frequent throat pain , untreated dental caries and chronically infected tonsils made up the optimal subset of factors for predicting the GBI Total Score .
RESULTS	However , in a random sample of patients ( n = 56 ) for whom preoperative diary-based data were also available , somewhat better predictive ability was achieved based on just two diary items : number of days with throat pain and with fever during the preceding few months ( correlation coefficient , r , between observed and fitted scores improved from 0.39 to 0.55 ) .
RESULTS	Yet , the precision of even these predictions was still quite low .
CONCLUSIONS	Adult patients with recurrent pharyngitis were on average satisfied after tonsillectomy , regardless of the aetiology of the episodes .
CONCLUSIONS	Clinical factors rather modestly predicted which patients benefited most from the operation .

###24714829
OBJECTIVE	To determine the impact of supplemental zinc , vitamin A , and glutamine alone or in combination on growth , intestinal barrier function , stress and satiety-related hormones among Brazilian shantytown children with low median height-for-age z-scores .
METHODS	A randomized , double-blind , placebo-controlled trial was conducted in children aged two months to nine years from the urban shanty compound community of Fortaleza , Brazil .
METHODS	Demographic and anthropometric information was assessed .
METHODS	The random treatment groups available for testing ( a total of 120 children ) were as follows : ( 1 ) glutamine alone , n = 38 ; ( 2 ) glutamine plus vitamin A plus zinc , n = 37 ; and a placebo ( zinc plus vitamin A vehicle ) plus glycine ( isonitrogenous to glutamine ) control treatment , n = 38 .
METHODS	Leptin , adiponectin , insulin-like growth factor ( IGF-1 ) , and plasma levels of cortisol were measured with immune-enzymatic assays ; urinary lactulose/mannitol and serum amino acids were measured with high-performance liquid chromatography .
METHODS	ClinicalTrials.gov : NCT00133406 .
RESULTS	Glutamine treatment significantly improved weight-for-height z-scores compared to the placebo-glycine control treatment .
RESULTS	Either glutamine alone or all nutrients combined prevented disruption of the intestinal barrier function , as measured by the percentage of lactulose urinary excretion and the lactulose : mannitol absorption ratio .
RESULTS	Plasma leptin was negatively correlated with plasma glutamine ( p = 0.002 ) and arginine ( p = 0.001 ) levels at baseline .
RESULTS	After glutamine treatment , leptin was correlated with weight-for-age ( WAZ ) and weight-for-height z-scores ( WHZ ) ( p0 .002 ) at a 4-month follow-up .
RESULTS	In addition , glutamine and all combined nutrients ( glutamine , vitamin A , and zinc ) improved the intestinal barrier function in these children .
CONCLUSIONS	Taken together , these findings reveal the benefits of glutamine alone or in combination with other gut-trophic nutrients in growing children via interactions with leptin .

###24910270
BACKGROUND	Undecylenoyl phenylalanine is a novel skin-lightening agent , probably acting as - melanocyte-stimulating hormone ( - MSH ) and beta-adrenergic receptor ( - ADR ) antagonist .
OBJECTIVE	The objective of this double-blind randomized comparative study was to evaluate the efficacy and safety of a preparation containing undecylenoyl phenylalanine 2 % in the topical treatment of melasma in females .
METHODS	Forty female patients with melasma were randomly assigned to apply either the active preparation or the vehicle alone , twice daily for 12weeks .
METHODS	Patients were evaluated monthly for efficacy and safety .
RESULTS	In all , 37 patients completed the study .
RESULTS	Of the 20 patients on active treatment , no one responded completely , but 17 ( 85 % ) had partial response .
RESULTS	Of them , 11 had moderate improvement and six had marked improvement .
RESULTS	Lightening of the lesions was evident from the first follow-up visit at 4weeks .
RESULTS	A statistically significant difference ( P < 0.001 ) in efficacy between the active preparation and the vehicle was documented .
RESULTS	Using patient assessment ratings , 80 % were extremely satisfied or satisfied with the result .
RESULTS	The reported side effects were minor and included erythema and itching or burning at the site of application .
CONCLUSIONS	Undecylenoyl phenylalanine 2 % achieved a significant lightening of melasma lesions with minimal side effects .

###24553807
OBJECTIVE	Older men are at risk of dying of melanoma .
OBJECTIVE	To assess attendance at and clinical outcomes of clinical skin examinations ( CSEs ) in older men exposed to a video-based behavioral intervention .
METHODS	This was a behavioral randomized clinical trial of a video-based intervention in men aged at least 50 years .
METHODS	Between June 1 and August 31 , 2008 , men were recruited , completed baseline telephone interviews , and were than randomized to receive either a video-based intervention ( n = 469 ) or brochures only ( n = 461 ; overall response rate ,37.1 % ) and were again interviewed 7 months later ( n = 870 ; 93.5 % retention ) .
METHODS	Video on skin self-examination and skin awareness and written informational materials .
METHODS	The control group received written materials only .
METHODS	Participants who reported a CSE were asked for the type of CSE ( skin spot , partial body , or whole body ) , who initiated it , whether the physician noted any suspicious lesions , and , if so , how lesions were managed .
METHODS	Physicians completed a case report form that included the type of CSE , who initiated it , the number of suspicious lesions detected , how lesions were managed ( excision , nonsurgical treatment , monitoring , or referral ) , and pathology reports after lesion excision or biopsy .
RESULTS	Overall , 540 of 870 men ( 62.1 % ) self-reported a CSE since receiving intervention materials , and 321 of 540 ( 59.4 % ) consented for their physician to provide medical information ( received for 266 of 321 [ 82.9 % ] ) .
RESULTS	Attendance of any CSE was similar between groups ( intervention group , 246 of 436 [ 56.4 % ] ; control group , 229 of 434 [ 52.8 % ] ) , but men in the intervention group were more likely to self-report a whole-body CSE ( 154 of 436 [ 35.3 % ] vs 118 of 434 [ 27.2 % ] for control group ; P = .01 ) .
RESULTS	Two melanomas , 29 squamous cell carcinomas , and 38 basal cell carcinomas were diagnosed , with a higher proportion of malignant lesions in the intervention group ( 60.0 % vs 40.0 % for controls ; P = .03 ) .
RESULTS	Baseline attitudes , behaviors , and skin cancer history were associated with higher odds of CSE and skin cancer diagnosis .
CONCLUSIONS	A video-based intervention may increase whole-body CSE and skin cancer diagnosis in older men .
BACKGROUND	anzctr.org.au Identifier : ACTRN12608000384358 .

###25267266
BACKGROUND	The results of conservative treatment of knee osteoarthritis ( OA ) are generally evaluated in epidemiological studies with clinical outcome measures as primary outcomes .
BACKGROUND	Biomechanical evaluation of orthoses shows that there are potentially beneficial biomechanical changes to joint loading ; however , evaluation in relation to clinical outcome measures in longitudinal studies is needed .
OBJECTIVE	We asked ( 1 ) is there an immediate effect on gait in patients using a laterally wedged insole or valgus knee brace ; ( 2 ) is there a late ( 6 weeks ) effect ; and ( 3 ) is there a difference between subgroups within each group with respect to patient compliance , body mass index , and OA status ?
METHODS	This was a secondary analysis of data from a previous randomized controlled trial of patients with early medial knee OA .
METHODS	A total of 91 patients were enrolled in that trial , and 73 ( 80 % ) completed it after 6 months .
METHODS	Of the enrolled patients , 80 ( 88 % ) met prespecified inclusion criteria for analysis in the present study .
METHODS	The patients were randomized to an insole or brace .
METHODS	Gait was analyzed with and without wearing the orthosis ( insole or brace ) at baseline and after 6 weeks .
METHODS	Measurements were taken of the knee adduction moment , ground reaction force , moment arm , walking speed , and toe-out angle .
METHODS	Data were analyzed with regression analyses based on an intention-to-treat principle .
RESULTS	A mean reduction of 4 % ( 10 ) ( 95 % confidence interval [ CI ] , -0.147 to -0.03 , p = 0.003 ) of the peak knee adduction moment and 4 % ( 13 ) ( 95 % CI , -0.009 to -0.001 , p = 0.01 ) of the moment arm at baseline was observed in the insole group when walking with an insole was compared with walking without an insole .
RESULTS	A mean reduction of 1 % ( 10 ) ( 95 % CI , -0.002 to -0.001 , p = 0.001 ) of the peak knee adduction moment and no reduction of the moment arm were measured after 6 weeks .
RESULTS	No reduction of knee adduction moment , moment arm , or ground reaction force was seen in the brace group at baseline and after 6 weeks .
RESULTS	Subgroup analysis showed no differences in biomechanical effect for obesity , stage of OA , and whether patients showed a clinical response to the treatment .
CONCLUSIONS	Laterally wedged insoles unload the medial compartment only at baseline in patients with varus alignment and by an amount that might not be clinically important .
CONCLUSIONS	No biomechanical alteration was seen after 6 weeks of wearing the insole .
CONCLUSIONS	Valgus brace therapy did not result in any biomechanical alteration .
CONCLUSIONS	Taken together , this study does not show a clinically relevant biomechanical effect of insole and brace therapy in patients with varus medial knee OA .
METHODS	Level I , therapeutic study .
METHODS	See Instructions for Authors for a complete description of levels of evidence .

###24439984
BACKGROUND	In patients with severe aortic stenosis ( AS ) , treatment with angiotensin-converting enzyme inhibitors has previously been considered contraindicated .
BACKGROUND	However , there is a lack of clinical evidence to confirm these potential hemodynamic risks and benefits .
METHODS	Forty-four patients with severe AS ( aortic valve area < 1 cm ( 2 ) ) were randomized to treatment with trandolapril 22 mg daily/placebo ( 1:1 ) .
METHODS	Right heart catheterization and echocardiography were performed at rest and during exercise at baseline and on day 3 .
METHODS	Follow-up was performed before valve replacement or after a maximum of 8 weeks , when exercise echocardiography was repeated .
RESULTS	Compared with placebo , systolic blood pressure and systemic arterial compliance significantly changed at day 3 ( -14 11 vs -5 13 mm Hg , P = .02 , and 0.08 0.16 vs -0.05 0.86 mL/m ( 2 ) per mm Hg , P = .03 , respectively ) .
RESULTS	Changes in left ventricular end systolic volume ( LVESV ) was nonsignificant ( -8 9 vs -3 11 mL , P = .17 ) .
RESULTS	At a median of 49 days of follow-up , changes in LVESV and N-terminal pro-brain natriuretic peptide were even lower revealing significant differences between the groups ( -7.8 2.6 vs -0.5 2.5 mL , P = .04 , and -19 7 vs 0.8 6 pmol/L , P = .04 , respectively ) .
RESULTS	No episodes of symptomatic hypotension were noted , and other hemodynamic parameters remained unchanged .
CONCLUSIONS	Angiotensin-converting enzyme inhibition in severe AS caused a decrease in LVESV and N-terminal pro-brain natriuretic peptide with other hemodynamic parameters preserved both at rest and during exercise implying hemodynamic improvement with left ventricular unloading .

###25189167
OBJECTIVE	Alternative cerebral fuels are reputed to provide neuroprotection during hypoglycaemia , particularly in breastfed babies .
OBJECTIVE	We measured concentrations of alternative cerebral fuels in hypoglycaemic babies in the first 48h .
METHODS	Babies were 35weeks , 48h old and at risk of hypoglycaemia ( infant of diabetic , preterm , small or large ) .
METHODS	Plasma glucose , - hydroxybutyrate , lactate and insulin concentrations were measured in babies who had been hypoglycaemic ( < 2.6 mM ) for > 1h .
RESULTS	Samples were taken from 35 hypoglycaemic babies at 3.7 ; 1.8-39 .6 ( median ; range ) hours after birth .
RESULTS	Concentrations of glucose and - hydroxybutyrate were low ( 2.03 ; 0.19-3 .39 mM and 0.06 ; 0.00-1 .20 mM ) , but lactate concentrations varied widely ( 3.06 ; 0.02-7 .96 mM ) .
RESULTS	Infants of diabetics had lower - hydroxybutyrate and higher insulin concentrations , but mode of feeding did not influence plasma concentrations of alternative cerebral fuels .
CONCLUSIONS	Hypoglycaemic babies within the first 48h after birth are unlikely to receive neuroprotection from ketones .
CONCLUSIONS	However , lactate may provide an alternative cerebral fuel for many .
CONCLUSIONS	Lactate , rather than ketones , may provide alternative cerebral fuel in hypoglycaemic newborns .
BACKGROUND	ACTRN12608000623392 .

###24603844
BACKGROUND	There is a wide variability in measurement methodology of physical activity .
BACKGROUND	This study investigated the effect of different analysis techniques on the statistical power of physical activity outcomes after pulmonary rehabilitation .
METHODS	Physical activity was measured with an activity monitor armband in 57 patients with COPD ( mean SD age , 66 7 years ; FEV1 , 46 17 % predicted ) before and after 3 months of pulmonary rehabilitation .
METHODS	The choice of the outcome ( daily number of steps [ STEPS ] , time spent in at least moderate physical activity [ TMA ] , mean metabolic equivalents of task level [ METS ] , and activity time [ ACT ] ) , impact of weekends , number of days of assessment , postprocessing techniques , and influence of duration of daylight time ( DT ) on the sample size to achieve a power of 0.8 were investigated .
RESULTS	The STEPS and ACT ( 1.6-2 .3 metabolic equivalents of task ) were the most sensitive outcomes .
RESULTS	Excluding weekends decreased the sample size for STEPS ( 83 vs 56 ) , TMA ( 160 vs 148 ) , and METS ( 251 vs 207 ) .
RESULTS	Using 4 weekdays ( STEPS and TMA ) or 5 weekdays ( METS ) rendered the lowest sample size .
RESULTS	Excluding days with < 8 h wearing time reduced the sample size for STEPS ( 56 vs 51 ) .
RESULTS	Differences in DT were an important confounder .
CONCLUSIONS	Changes in physical activity following pulmonary rehabilitation are best measured for 4 weekdays , including only days with at least 8 h of wearing time ( during waking hours ) and considering the difference in DT as a covariate in the analysis .
BACKGROUND	ClinicalTrials.gov ; No. : NCT00948623 ; URL : www.clinicaltrials.gov .

###25264016
OBJECTIVE	While studies have looked into the effects of Maitland mobilization on symptom relief , to date , no work has specifically looked at the effects of Mulligan mobilization .
OBJECTIVE	The objective of this work was to compare the effectiveness of Maitland and Mulligan 's mobilization and exercises on pain response , range of motion ( ROM ) and functional ability in patients with mechanical neck pain .
METHODS	A total sample of 60 subjects ( 21-45 years of age ) with complaints of insidious onset of mechanical pain that has lasted for less than 12 weeks and reduced ROM were randomly assigned to : group I - Maitland mobilization and exercises ; group - II Mulligan mobilization and exercises ; and group-III exercises only , and assessed for dependent variables by a blinded examiner .
RESULTS	Post measurement readings revealed statistical significance with time ( p < 0.00 ) and no significance between groups ( p > 0.05 ) indicating no group is superior to another after treatment and at follow-up .
RESULTS	The effect sizes between the treatment groups were small .
CONCLUSIONS	Our results showed that manual therapy interventions were no better than supervised exercises in reducing pain , improving ROM and neck disability .

###24629480
BACKGROUND	Waterpipe use has increased dramatically in the Middle East and other parts of the world .
BACKGROUND	Many users exhibit signs of dependence , including withdrawal and difficulty quitting , but there is no evidence base to guide cessation efforts .
METHODS	We developed a behavioral cessation program for willing-to-quit waterpipe users , and evaluated its feasibility and efficacy in a pilot , two arm , parallel group , randomized , open label trial in Aleppo , Syria .
METHODS	Fifty adults who smoked waterpipe 3 times per week in the last year , did not smoke cigarettes , and were interested in quitting were randomized to receive either brief ( 1 in-person session and 3 phone calls ) or intensive ( 3 in-person sessions and 5 phone calls ) behavioral cessation treatment delivered by a trained physician in a clinical setting .
METHODS	The primary efficacy end point of the developed interventions was prolonged abstinence at three months post-quit day , assessed by self-report and exhaled carbon monoxide levels of < 10 ppm .
METHODS	Secondary end points were 7 day point-prevalent abstinence and adherence to treatment .
RESULTS	Thirty percent of participants were fully adherent to treatment , which did not vary by treatment group .
RESULTS	The proportions of participants in the brief and intensive interventions with prolonged abstinence at the 3-month assessment were 30.4 % and 44.4 % , respectively .
RESULTS	Previous success in quitting ( OR = 3.57 ; 95 % CI = 1.03-12 .43 ) predicted cessation .
RESULTS	Higher baseline readiness to quit , more confidence in quitting , and being unemployed predicted a better adherence to treatment ( all p-values < 0.05 ) .
CONCLUSIONS	Brief behavioral cessation treatment for waterpipe users appears to be feasible and effective .

###24364800
OBJECTIVE	Young gay and bisexual men ( YGBM ) are disproportionally at risk of HIV infection due to sexual risk behaviors , which are often exacerbated by recreational drug use .
OBJECTIVE	However , there have been no evidence-based interventions targeting substance-using YGBM .
OBJECTIVE	This study was designed to test a brief motivational interviewing ( MI ) intervention to reduce both risky sex and drug use among HIV-negative YGBM .
METHODS	A total of 143 non-treatment-seeking YGBM ( ages 18-29 years ) who reported recent unprotected anal intercourse ( UAI ) and recreational drug use were randomized to 4 sessions of MI or 4 sessions of content-matched education .
METHODS	Participants were followed every 3 months for 1 year , and behavior change was examined across conditions and time for aggregated and day-level drug use and UAI .
RESULTS	Regardless of condition , participants reported significant reductions in UAI and substance use over time .
RESULTS	However , YGBM in the MI condition were 18 % less likely to use drugs and 24 % less likely to engage in UAI than YGBM in the education condition .
CONCLUSIONS	The results support the utility of MI , compared with a content-matched education condition , to significantly reduce both UAI and drug use among YGBM .
CONCLUSIONS	Interventions may benefit from an emphasis on substance use reductions , which might indirectly lead to less frequent UAI .
CONCLUSIONS	Future research efforts should examine whether this type of brief MI intervention is effective when delivered by clinic or community settings utilized by YGBM .

###24660837
BACKGROUND	Data regarding immunomodulatory effects of parenteral n-3 fatty acids in sepsis are conflicting .
BACKGROUND	In this study , the effect of administration of parenteral n-3 fatty acids on markers of brain injury , incidence of sepsis-associated delirium , and inflammatory mediators in septic patients was investigated .
METHODS	Fifty patients with sepsis were randomized to receive either 2 ml/kg/day of a lipid emulsion containing highly refined fish oil ( equivalent to n-3 fatty acids 0.12 mg/kg/day ) during 7 days after admission to the intensive care unit or standard treatment .
METHODS	Markers of brain injury and inflammatory mediators were measured on days 1 , 2 , 3 and 7 .
METHODS	Assessment for sepsis-associated delirium was performed daily .
METHODS	The primary outcome was the difference in S-100 from baseline to peak level between both the intervention and the control group , compared by t-test .
METHODS	Changes of all markers over time were explored in both groups , fitting a generalized estimating equations model .
RESULTS	Mean difference in change of S-100 from baseline to peak level was 0.34 ( 95 % CI : -0.18 -0.85 ) between the intervention and control group , respectively ( P = 0.19 ) .
RESULTS	We found no difference in plasma levels of S-100 , neuron-specific enolase , interleukin ( IL ) -6 , IL-8 , IL-10 , and C-reactive protein between groups over time .
RESULTS	Incidence of sepsis-associated delirium was 75 % in the intervention and 71 % in the control groups ( risk difference 4 % , 95 % CI -24 -31 % , P = 0.796 ) .
CONCLUSIONS	Administration of n-3 fatty acids did not affect markers of brain injury , incidence of sepsis-associated delirium , and inflammatory mediators in septic patients .

###24887576
OBJECTIVE	To assess whether low-dose contrast medium and low-tube voltage computed tomography ( CT ) venography can be used for clinical diagnosis .
METHODS	This prospective study included 63 patients who were randomized into 3 groups and administered contrast medium of either 600 , 500 , or 400 mg of iodine per kilogram ( mgI/kg ) .
METHODS	All patients underwent dual-energy CT at either 80 or 135 kilovolt ( peak ) ( kV [ p ] ) .
METHODS	Control images ( 120 kV [ p ] ) were acquired from them and were compared with 80-kV ( p ) images .
METHODS	The mean CT values of the bilateral femoral and popliteal veins were compared .
RESULTS	The mean CT values of the 80-kV ( p ) images were significantly higher than 120-kV ( p ) images for all doses .
RESULTS	No significant difference was observed for the CT values of the 80-kV ( p ) images with the 400-mgI/kg dose and the control images ( 600 mgI/kg at 120 kV [ p ] ) .
CONCLUSIONS	Low tube voltage enabled a reduction of contrast medium to 400 mgI/kg for CT venography .

###24884787
BACKGROUND	The dipeptidyl-peptidase-IV ( DPP-4 ) inhibitors , including sitagliptin , are used for the treatment of type 2 diabetes mellitus ( T2DM ) .
BACKGROUND	Adiponectin , an adipocyte-derived circulating protein , has anti-atherosclerotic and anti-diabetic properties and is effectively elevated in bloodstream by thiazolidinediones , an insulin sensitizer .
BACKGROUND	However , the effect of sitagliptin treatment on serum adiponectin level in T2DM has not fully elucidated in Japanese T2DM patients .
BACKGROUND	The aim of the present study was to examine the effect of sitagliptin treatment on serum adiponectin levels in T2DM subjects .
METHODS	Twenty-six consecutive Japanese T2DM outpatients were recruited between April 2011 and March 2013 , and randomized into the control ( conventional treatment , n = 10 ) group and sitagliptin treatment group ( n = 16 ) .
METHODS	Serum adiponectin was measured by enzyme-linked immunosorbent assay .
RESULTS	Indices of glycemic control , such as hemoglobin A1c , glycated albumin , and 1.5-anhydro-D-glucitol , were significantly improved after the three-month treatment in both the control and sitagliptin groups .
RESULTS	Serum adiponectin level was significantly increased in sitagliptin group from 6.70.8 to 7.41.0 g/mL without change of body mass index ( p = 0.034 ) , while serum adiponectin level was not altered in the control group ( p = 0.601 ) .
CONCLUSIONS	In Japanese T2DM patients , serum adiponectin level was elevated by three-month treatment with sitagliptin without change of body weight .
BACKGROUND	UMIN000004721 .

###25125271
OBJECTIVE	In this study , Increasing Viral Testing in the Emergency Department ( InVITED ) , the authors investigated if a brief intervention about human immunodeficiency virus ( HIV ) and hepatitis C virus ( HCV ) risk-taking behaviors and drug use and misuse in addition to a self-administered risk assessment , compared to a self-administered risk assessment alone , increased uptake of combined screening for HIV and HCV , self-perception of HIV/HCV risk , and impacted beliefs and opinions on HIV/HCV screening .
METHODS	InVITED was a randomized , controlled trial conducted at two urban emergency departments ( EDs ) from February 2011 to March 2012 .
METHODS	ED patients who self-reported drug use within the past 3 months were invited to enroll .
METHODS	Drug misuse severity and need for a brief or more intensive intervention was assessed using the Alcohol , Smoking and Substance Involvement Screening Test ( ASSIST ) .
METHODS	Participants were randomly assigned to one of two study arms : a self-administered HIV/HCV risk assessment alone ( control arm ) or the assessment plus a brief intervention about their drug misuse and screening for HIV/HCV ( intervention arm ) .
METHODS	Beliefs on the value of combined HIV/HCV screening , self-perception of HIV/HCV risk , and opinions on HIV/HCV screening in the ED were measured in both study arms before the HIV/HCV risk assessment ( pre ) , after the assessment in the control arm , and after the brief intervention in the intervention arm ( post ) .
METHODS	Participants in both study arms were offered free combined rapid HIV/HCV screening .
METHODS	Uptake of screening was compared by study arm .
METHODS	Multivariable logistic regression models were used to evaluate factors related to uptake of screening .
RESULTS	Of the 395 participants in the study , the median age was 28 years ( interquartile range [ IQR ] = 23 to 38 years ) , 44.8 % were female , 82.3 % had ever been tested for HIV , and 67.3 % had ever been tested for HCV .
RESULTS	Uptake of combined rapid HIV/HCV screening was nearly identical by study arm ( 64.5 % vs. 65.2 % ; = -0.7 % ; 95 % confidence interval [ CI ] = -10.1 % to 8.7 % ) .
RESULTS	Of the 256 screened , none had reactive HIV antibody tests , but seven ( 2.7 % ) had reactive HCV antibody tests .
RESULTS	Multivariable logistic regression analysis results indicated that uptake of screening was not related to study arm assignment , total ASSIST drug scores , need for an intervention for drug misuse , or HIV/HCV sexual risk assessment scores .
RESULTS	However , uptake of screening was greater among participants who indicated placing a higher value on combined rapid HIV/HCV screening for themselves and all ED patients and those with higher levels of perceived HIV/HCV risk .
RESULTS	Uptake of combined rapid HIV/HCV screening was not related to changes in beliefs regarding the value of combined HIV/HCV screening or self-perceived HIV/HCV risk ( post - vs. pre-risk assessment with or without a brief intervention ) .
RESULTS	Opinions regarding the ED as a venue for combined rapid HIV/HCV screening were not related to uptake of screening .
CONCLUSIONS	Uptake of combined rapid HIV/HCV screening is high and considered valuable among drug using and misusing ED patients with little concern about the ED as a screening venue .
CONCLUSIONS	The brief intervention investigated in this study does not appear to change beliefs regarding screening , self-perceived risk , or uptake of screening for HIV/HCV in this population .
CONCLUSIONS	Initial beliefs regarding the value of screening and self-perceived risk for these infections predict uptake of screening .

###24366433
OBJECTIVE	To investigate the effects of a single instillation of hypotonic 0.18 % sodium hyaluronate artificial tears on wavefront aberrations in dry eye patients .
METHODS	Fifty patients with dry eye were recruited into this single-center , prospective , double-masked , randomized controlled trial .
METHODS	Patients were randomly assigned to receive one drop of preservative-free , hypotonic 0.18 % sodium hyaluronate ( treatment ) in one eye and one drop of sterile 0.9 % sodium chloride solution ( control ) in the other eye .
METHODS	Ocular aberrations evaluated by a Hartmann-Shack aberrometer and severity of dry eye symptoms graded by a questionnaire ( at baseline , 1 , 10 , 30 , 60 , and 120 minutes after instillation ) were the main outcome measures .
RESULTS	After a single instillation of one drop of the allocated eye drops , there were no statistically significant differences between the treatment and control groups in total higher-order aberrations , coma , and spherical aberrations during the study period ( p = 0.40 , 0.57 , and 0.16 , respectively ) .
RESULTS	Although a statistically significant ( p = 0.04 ) decrease from baseline in spherical aberrations was noted in the treatment group at 1 minute following instillation , it gradually increased back to baseline values at later time points .
RESULTS	A statistically significant diminishment of dry eye symptoms compared with the placebo was reported at all time points by the treatment group ( p < 0.001 ) .
CONCLUSIONS	A single instillation of hypotonic 0.18 % sodium hyaluronate eye drops is safe and effective in alleviating subjective dry eye symptoms ; however , it does not appear to affect higher-order aberrations in moderate to severe dry eye patients .

###24618327
OBJECTIVE	We described the change in visual acuity experienced by eyes successfully treated for bacterial keratitis .
METHODS	This was a prospective cohort study of a subset of study participants who had previously enrolled in the Steroids for Corneal Ulcers Trial ( SCUT ) .
METHODS	All study participants had been diagnosed with culture-proven bacterial keratitis before enrollment in SCUT and subsequently were randomized to adjunctive topical corticosteroids or placebo .
METHODS	During SCUT , we monitored study participants at enrollment , 3 weeks , 3 months , and 12 months .
METHODS	We invited a subset to complete a comprehensive eye examination approximately 4 years after enrollment in SCUT .
METHODS	Certified refractionists assessed best spectacle-corrected visual acuity ( BSCVA ) using the same protocol at each study visit .
RESULTS	We examined 50 SCUT participants at 4 years after enrollment .
RESULTS	Among those in this cohort , mean logMAR BSCVA at enrollment was 0.85 ( Snellen equivalent , 20/160 ; 95 % confidence interval [ CI ] , 0.71-0 .99 ) .
RESULTS	On average , visual acuity improved by 2.9 logMAR lines from enrollment to 3 weeks ( P < 0.001 ) , 1.2 lines from 3 weeks to 3 months ( P = 0.002 ) , and 0.8 lines from 3 to 12 months ( P = 0.01 ) .
RESULTS	The BSCVA did not change significantly between 12 months and 4 years ( 0.04-line improvement , P = 0.88 ) .
RESULTS	After controlling for visual acuity at enrollment , BSCVA was not significantly different between the corticosteroid and placebo groups at 4 years ( P = 0.53 ) .
CONCLUSIONS	Cases of bacterial keratitis may continue to demonstrate improvements in visual acuity up to 12 months following diagnosis , but further improvements are unlikely .
CONCLUSIONS	These findings may guide the appropriate timing of surgical intervention in these patients .
CONCLUSIONS	( ClinicalTrials.gov number , NCT00324168 . )

###25307707
BACKGROUND	The analgesic effect of the adductor canal block ( ACB ) after knee surgery has been evaluated in a number of trials .
BACKGROUND	We hypothesized that the ACB would provide substantial pain relief to patients responding with moderate to severe pain after arthroscopic knee surgery .
METHODS	Fifty subjects with moderate to severe pain after arthroscopic knee surgery were enrolled in this placebo-controlled , blinded trial .
METHODS	All subjects received two ACBs ; an initial ACB with either 30ml ropivacaine 7.5 mg/ml ( n = 25 ) ( R group ) or saline ( n = 25 ) ( C group ) and after 45min a second ACB with the opposite study medication , according to randomization .
METHODS	Primary outcome was pain during 45 degrees active flexion of the knee at 45min after the first block , assessed on a 0-100mm visual analogue scale .
METHODS	Secondary outcome measures were : pain at rest and during flexion of the knee , worst pain experienced during a 5-m walk , patient 's evaluation of muscle strength during walk , and amount of sufentanil administered during the 90-min study period .
RESULTS	Regarding primary outcome , mean pain score difference between groups was 34 ( 95 % CI : 25 to 44 ) mm , P < 0.001 , in favour of the R group .
RESULTS	At rest , mean pain score difference was 32 ( 23 to 41 ) mm , P < 0.001 , and during walk : 21 ( 6 to 36 ) mm , P = 0.01 in favour of the R group .
RESULTS	There were no differences between groups regarding other secondary outcome measures .
CONCLUSIONS	The ACB is a relevant option for patients with moderate to severe pain after arthroscopic knee surgery .

###24563158
OBJECTIVE	To prospectively evaluate if training with direct feedback improves grading accuracy of inexperienced readers for Crohn 's disease activity on magnetic resonance imaging ( MRI ) .
METHODS	Thirty-one inexperienced readers assessed 25 cases as a baseline set .
METHODS	Subsequently , all readers received training and assessed 100 cases with direct feedback per case , randomly assigned to four sets of 25 cases .
METHODS	The cases in set 4 were identical to the baseline set .
METHODS	Grading accuracy , understaging , overstaging , mean reading times and confidence scores ( scale 0-10 ) were compared between baseline and set 4 , and between the four consecutive sets with feedback .
METHODS	Proportions of grading accuracy , understaging and overstaging per set were compared using logistic regression analyses .
METHODS	Mean reading times and confidence scores were compared by t-tests .
RESULTS	Grading accuracy increased from 66 % ( 95 % CI , 56-74 % ) at baseline to 75 % ( 95 % CI , 66-81 % ) in set 4 ( P = 0.003 ) .
RESULTS	Understaging decreased from 15 % ( 95 % CI , 9-23 % ) to 7 % ( 95 % CI , 3-14 % ) ( P < 0.001 ) .
RESULTS	Overstaging did not change significantly ( 20 % vs 19 % ) .
RESULTS	Mean reading time decreased from 6 min 37 s to 4 min 35 s ( P < 0.001 ) .
RESULTS	Mean confidence increased from 6.90 to 7.65 ( P < 0.001 ) .
RESULTS	During training , overall grading accuracy , understaging , mean reading times and confidence scores improved gradually .
CONCLUSIONS	Inexperienced readers need training with at least 100 cases to achieve the literature reported grading accuracy of 75 % .
CONCLUSIONS	Most radiologists have limited experience of grading Crohn 's disease activity on MRI .
CONCLUSIONS	Inexperienced readers need training in the MRI assessment of Crohn 's disease .
CONCLUSIONS	Grading accuracy , understaging , reading time and confidence scores improved during training .
CONCLUSIONS	Radiologists and residents show similar accuracy in grading Crohn 's disease .
CONCLUSIONS	After 100 cases , grading accuracy can be reached as reported in the literature .

###24928796
OBJECTIVE	The aim of this study was to assess the various doses of oral oxybutynin on cardiac autonomic modulation by measuring short-term heart rate variability ( HRV ) indexes during supine rest position .
METHODS	Eight male healthy subjects ( 20-23years ) participated in the double-blind crossover randomized study .
METHODS	The single dose of oxybutynin ( 2.5 , 5 and 10mg ) or placebo was given to the volunteers in four sessions within 5-day intervals .
METHODS	Before and minutes of 30 , 60 , 90 and 120 after administration , lead II electrocardiogram ( ECG ) was recorded for 5min .
METHODS	ECG extracted RR intervals data became the base of the calculation of time domain and frequency domain HRV parameters , which indicate cardiac autonomic activity .
METHODS	Statistical analysis was done by using the nonparametric Wilcoxon and Kruskal-Wallis tests .
RESULTS	The data analysis has revealed that MNN ( P < 0.001 ) , SDNN ( P < 0.05 ) , PNN50 % ( P < 0.01 ) , RMSSD ( P < 0.001 ) , HFnu ( P < 0.05 ) and LF/HF ratio ( P < 0.05 ) values were significantly increased relative to baseline at various time points in all the groups except in placebo group .
RESULTS	LFnu ( P < 0.05 ) values were significantly increased relative to baseline at various time points in all the groups except in placebo group .
CONCLUSIONS	Our findings have revealed that acute consumption of 2.5 , 5 and 10mg oxybutynin ( an anticholinergic compound ) in the juvenile healthy male subjects produces a cholinergic effect according to time and frequency domain of HRV indexes .

###25037034
BACKGROUND	Annual seasonal influenza epidemics are particularly dangerous for the very young , the elderly and chronically ill individuals , in whom infection can cause severe morbidity , hospitalization and death .
BACKGROUND	Existing , nonadjuvanted influenza vaccines exhibit a suboptimal immunogenicity and efficacy in immunologically naive subjects such as young children .
METHODS	This phase II , randomized clinical trial was conducted to evaluate the antibody and cell-mediated responses to a trivalent influenza vaccine administered without adjuvant ( TIV ) or adjuvanted with MF59 ( ATIV ) in previously nonvaccinated children less than 3 years of age .
RESULTS	The MF59-adjuvanted vaccine was well tolerated , and induced higher titers of hemagglutination inhibition antibodies able to recognize strains different from the one used in the vaccine ( heterovariant ) than TIV .
RESULTS	The presence of the adjuvant MF59 induced a larger expansion of vaccine-specific CD4 T cells .
RESULTS	Interestingly , the adjuvant MF59 did not modify the cytokine profile of the elicited T cells , characterized by the production of IL-2 and TNF - , and did not bias the response toward either Th1 or Th2 .
RESULTS	The advantage of ATIV over TIV was more pronounced for the virus strains that had not circulated in the years that preceded this study and for the heterovariant strains .
CONCLUSIONS	These data highlight the relevant role played by the oil-in-water adjuvant MF59 in enhancing the immunogenicity of inactivated influenza vaccines in immunologically naive individuals .

###25561817
OBJECTIVE	To study the clinical efficacy of traditional Chinese medicine ( TCM ) intervention `` tonifying the kidney to promote liver regeneration and repair by affecting stem cells and their microenvironment '' ( `` TTK '' ) for treating liver failure due to chronic hepatitis B.
METHODS	We designed the study as a randomized controlled clinical trial .
METHODS	Registration number of Chinese Clinical Trial Registry is ChiCTR-TRC-12002961 .
METHODS	A total of 144 patients with liver failure due to infection with chronic hepatitis B virus were enrolled in this randomized controlled clinical study .
METHODS	Participants were randomly assigned to the following three groups : ( 1 ) a modern medicine control group ( MMC group , 36 patients ) ; ( 2 ) a `` tonifying qi and detoxification '' ( `` TQD '' ) group ( 72 patients ) ; and ( 3 ) a `` tonifying the kidney to promote liver regeneration and repair by affecting stem cells and their microenvironment '' ( `` TTK '' ) group ( 36 patients ) .
METHODS	Patients in the MMC group received general internal medicine treatment ; patients in the `` TQD '' group were given a TCM formula `` tonifying qi and detoxification '' and general internal medicine treatment ; patients in the `` TTK '' group were given a TCM formula of `` TTK '' and general internal medicine treatment .
METHODS	All participants were treated for 8 wk and then followed at 48 wk following their final treatment .
METHODS	The primary efficacy end point was the patient fatality rate in each group .
METHODS	Measurements of various virological and biochemical indicators served as secondary endpoints .
METHODS	The one-way analysis of variance and the t-test were used to compare patient outcomes in the different treatment groups .
RESULTS	At the 48-wk post-treatment time point , the patient fatality rates in the MMC , `` TQD '' , and `` TTK '' groups were 51.61 % , 35.38 % , and 16.67 % , respectively , and the differences between groups were statistically significant ( P < 0.05 ) .
RESULTS	However , there were no significant differences in the levels of hepatitis B virus DNA or prothrombin activity among the three groups ( P > 0.05 ) .
RESULTS	Patients in the `` TTK '' group had significantly higher levels of serum total bilirubin compared to MMC subjects ( 339.40 mol/L 270.09 mol/L vs 176.13 mol/L 185.70 mol/L , P = 0.014 ) .
RESULTS	Serum albumin levels were significantly increased in both the `` TQD '' group and `` TTK '' group as compared with the MMC group ( 31.30 g/L 4.77 g/L , 30.72 g/L 2.89 g/L vs 28.57 g/L 4.56 g/L , P < 0.05 ) .
RESULTS	There were no significant differences in levels of alanine transaminase among the three groups ( P > 0.05 ) .
RESULTS	Safety data showed that there was one case of stomachache in the `` TQD '' group and one case of gastrointestinal side effect in the `` TTK '' group .
CONCLUSIONS	Treatment with `` TTK '' improved the survival rates of patients with liver failure due to chronic hepatitis B. Additionally , liver tissue was regenerated and liver function was restored .

###24259652
BACKGROUND	Drug therapy problems , adverse drug events ( ADEs ) , and symptom burden are high among adults with disabilities .
OBJECTIVE	To compare the effects of a modified medication therapy management ( MTM ) program within a self-efficacy workshop versus the workshop alone or usual care on symptom burden among adults with activity limitations .
METHODS	Three-group randomized controlled trial among adults ( age 40 and older ) with self-reported activity limitations in community practice .
METHODS	8 weekly Living Well With a Disability ( LWD ) 2-hour workshop sessions with and without a collaborative medication management ( CMM ) module .
METHODS	mean number of moderate to very severe symptoms from a list of 11 physical and mental symptoms .
METHODS	Process measures : changes in medication regimens and self-reported ADEs .
METHODS	general linear mixed models ( continuous outcomes ) and generalized estimating equations ( categorical outcomes ) .
RESULTS	Participants had high symptom burden , low physical health , and took many medications .
RESULTS	There was a significant increase in ADE reporting in the LWD + CMM group relative to the other 2 groups ( Study group Time P = .014 ) , and there were significantly more changes in medication regimens in the LWD + CMM group ( P = .013 LWD only vs LWD + CMM ) .
RESULTS	The oldest third of participants had significantly fewer mean symptoms but received more intense CMM .
RESULTS	There was no difference between the LWD-only , LWD + CMM , and usual care groups in symptom burden over time .
CONCLUSIONS	Pharmacist MTM practices and MTM guidelines may need to be modified to affect symptom burden in a population with physical activity limitations .

###24737460
OBJECTIVE	In both dementia with Lewy bodies ( DLB ) and Parkinson 's disease dementia ( PDD ) , attentional dysfunction is a core clinical feature together with disrupted episodic memory .
OBJECTIVE	This study evaluated the cognitive effects of memantine in DLB and PDD using automated tests of attention and episodic memory .
METHODS	A randomised double-blind , placebo-controlled , 24-week three centre trial of memantine ( 20mg/day ) was conducted in which tests of attention ( simple and choice reaction time ) and word recognition ( immediate and delayed ) from the CDR System were administered prior to dosing and again at 12 and 24weeks .
METHODS	Although other results from this study have been published , the data from the CDR System tests were not included and are presented here for the first time .
RESULTS	Data were available for 51 patients ( 21 DLB and 30 PDD ) .
RESULTS	In both populations , memantine produced statistically significant medium to large effect sized improvements to choice reaction time , immediate and delayed word recognition .
CONCLUSIONS	These are the first substantial improvements on cognitive tests of attention and episodic recognition memory identified with memantine in either DLB or PDD .

###24942155
BACKGROUND	This Phase IV , open-label , multicentre , randomized study ( MEnTOR ) compared two low-dose recombinant human follicle-stimulating hormone ( r-hFSH ) protocols for ovulation induction .
METHODS	This study was conducted in six Middle Eastern countries between March 2009 and March 2011 .
METHODS	Eligible women ( 18-37 years ) , with World Health Organization Group II anovulatory infertility , were randomized to receive r-hFSH ( starting daily dose : 75 IU ) as a chronic low-dose ( CLD ) ( 37.5 IU dose increase on Day 14 ) or low-dose ( LD ) ( 37.5 IU dose increase on Day 7 ) protocol if no follicles were 10 mm .
METHODS	The maximum r-hFSH daily dose permitted was 225 IU/day .
METHODS	The total length of ovarian stimulation could not exceed 35 days , unless ultrasound assessment suggested imminent follicular growth and maturation .
METHODS	Patients underwent only one treatment cycle .
METHODS	Primary endpoint : incidence of mono-follicular development .
METHODS	Secondary endpoints included : stimulation duration and rates of bi-follicular development ; human chorionic gonadotrophin administration rate ; clinical pregnancy ; and cycle cancellation ( owing to inadequate response ) .
METHODS	Adverse events ( AEs ) were recorded .
METHODS	The primary efficacy analysis was performed using data from all patients who received at least one dose of correct study medication , had at least one efficacy assessment , and no protocol violations at treatment start ( CLD group , n = 122 ; LD group , n = 125 ) .
RESULTS	Mono-follicular development rates ( primary endpoint ) were similar in both groups ( CLD : 56.6 % [ 69/122 ] versus LD : 55.2 % [ 69/125 ] , p = 0.93 ; primary efficacy analysis population ) .
RESULTS	Similarly , there were no significant differences between groups in bi-follicular development , clinical pregnancy or cycle cancellation ( inadequate response ) rates .
RESULTS	In patients who received human chorionic gonadotrophin injections , the mean duration of stimulation was 13.7 days in the CLD group and 12.9 days in the LD group .
RESULTS	Clinical pregnancy rates for those patients who received an hCG injection were similar in both groups ( CLD : 20.2 % [ 19/94 ] versus LD : 19.8 % [ 18/91 ] , p = 0.94 ; primary efficacy analysis population ) .
RESULTS	Most AEs were mild in severity .
RESULTS	Only one case of ovarian hyperstimulation syndrome was reported ( mild ; CLD group ) .
CONCLUSIONS	Efficacy and safety outcomes were similar for the two protocols .

###24336820
BACKGROUND	Human immunodeficiency virus ( HIV ) and malaria during pregnancy cause substantial perinatal mortality .
BACKGROUND	As co-trimoxazole ( CMX ) protects children and HIV-positive adults against malaria , we compared the effectiveness of daily CMX with sulfadoxine-pyrimethamine intermittent preventive treatment ( IPT-SP ) on malaria risk in HIV-positive pregnant women in a Plasmodium falciparum-endemic African area .
METHODS	From January 2009 to April 2011 , we included in a randomized noninferiority trial all HIV type 1-infected pregnant women ( 28 weeks ' gestation , CD4 count 200 cells/L , hemoglobin level 7 g/L ) in 19 health centers in Togo .
METHODS	Women were randomly assigned to daily 800 mg/160 mg CMX , or IPT-SP .
METHODS	The primary outcome was the proportion of malaria-free pregnancies .
METHODS	Other outcomes included malaria incidence , parasitemia , placental malaria , anemia , and infants ' birth weight .
RESULTS	Of 264 women randomly assigned to the CMX or IPT-SP group , 126 of 132 and 124 of 132 , respectively , were included in the analysis .
RESULTS	There were 33 confirmed cases of clinical malaria among 31 women in the CMX group , and 19 among 19 women in the IPT-SP group .
RESULTS	Ninety-five of 126 ( 75.4 % ) women in the CMX group and 105 of 124 ( 84.7 % ) in the IPT-SP group remained malaria-free during their pregnancy ( difference , 9.3 % ; 95 % confidence interval [ CI ] , -.53 to 19.1 , not meeting the predefined noninferiority criterion ) .
RESULTS	The incidence rate in intention-to-treat analysis was 108.8 malaria episodes per 100 person-years in CMX ( 95 % CI , 105.4-112 .2 ) and 90.1 in IPT-SP ( 95 % CI , 86.8-93 .4 ) ( not significant ) .
RESULTS	Prevalence of parasitemia was 16.7 % in the CMX group vs 28 % in the IPT-SP group ( P = .02 ) .
RESULTS	Histology revealed 20.3 % placental malaria in the CMX group vs. 24.6 % in the IPT-SP group ( not significant ) .
RESULTS	Grade 3-4 anemia was more frequent in the CMX group ( 10 % vs 4 % ; P = .008 ) .
RESULTS	No pregnant women died .
RESULTS	Median birth weight was similar .
CONCLUSIONS	Daily CMX was not noninferior to IPT-SP for preventing maternal malaria but safe and at least similar regarding parasitemia or placental malaria and birth outcomes .
CONCLUSIONS	Clinical Trials Registration ISRCTN98835811 .

###24445832
BACKGROUND	Tympanostomy with or without adenoidectomy is effective in preventing recurrences of acute otitis media ( RAOM ) , but little is known about the effect of these operations on the quality of life ( QOL ) .
BACKGROUND	We evaluated the efficacy of insertion of tympanostomy tubes with and without adenoidectomy for improving QOL in young children in a controlled , randomized trial .
METHODS	QOL was evaluated in the 159 children aged 10 months to 2 years participating in our larger study in which children with RAOM were randomly assigned to receive tympanostomy tubes , tympanostomy tubes with adenoidectomy or neither .
METHODS	The caregiver of the child completed otitis media-specific QOL questionnaires ( Otitis Media-6 ) at entry and after 4 months and 12 months of follow up .
RESULTS	Scores on the global ear-related QOL and the subsets of caregiver concern , emotional distress and physical suffering in the questionnaires improved with time during the follow up , but the groups did not differ from each other .
CONCLUSIONS	QOL in children with RAOM improves with time when the subjects are closely followed .
CONCLUSIONS	Tympanostomy with adenoidectomy does not provide any additional QOL benefit for children with RAOM , even though these operations are effective in preventing further otitis media episodes .

###24365043
OBJECTIVE	To evaluate risk factors for recurrent events in patients enrolled in the SteFlux ( Superficial Thromboembolism Fluxum ) clinical trial which compared different doses and duration of low molecular weight heparin ( parnaparin ) for superficial vein thrombosis ( SVT ) .
METHODS	Outpatients with acute SVT of at least 4 cm in length of the internal or external saphenous veins or their collaterals were randomized in a double blind fashion to receive either parnaparin 8500 UI aXa od for ten days followed by placebo for 20 days or 8500 UI aXa od for ten days followed by 6400 UI aXa od for 20 days or 4250 UI aXa od for 30 days .
METHODS	Outcomes were the composite of symptomatic and asymptomatic deep vein thrombosis , pulmonary embolism and SVT recurrence or extension in the first 30 + / -3 days with a 60 + / -3 day follow-up .
RESULTS	98 outcomes ( 14.7 % ) were recorded during 93 days among 664 patients ( M/F : 246/418 , mean age 65 ) .
RESULTS	After correction for treatment , outcomes during 33 days were associated with previous venous thromboembolism ( VTE ) and/or SVT and/or family history of VTE ( odds ratio-OR : 2.5 ; 95 % confidence interval - CI : 1.4-4 .8 ; p = 0.003 ) .
RESULTS	After stopping LMWH treatment , only the absence of varicose veins ( OR : 2.5 ; 95 % CI 1.3-5 .0 ; p = 0.004 ) and previous VTE and/or SVT and/or family history of VTE ( OR : 1.9 ; 95 % CI :1.0 -3.7 ; p = 0.048 ) were significantly associated with outcomes .
CONCLUSIONS	SVT patients with these factors may deserve a higher intensity and/or longer anticoagulant treatment .

###25682579
OBJECTIVE	Fingertip amputation is a common injury .
OBJECTIVE	Considerable controversy exists as to whether prophylactic antibiotics are necessary for this injury .
OBJECTIVE	Our goal was to compare the rate of infections among subgroups with and without prophylactic antibiotic treatment .
OBJECTIVE	The study hypothesis was that infection rates were similar in the 2 groups .
METHODS	This was a prospective randomized control trial of adult patients presenting with fingertip amputation with bone exposed , requiring surgical treatment .
METHODS	Patients were randomized to 2 groups : group 1 received no antibiotics , and group 2 received 1 g intravenous antibiotics ( cefazolin ) for 3 days .
METHODS	The 2 groups were matched for age , time to surgery , injury mechanism , and type of surgery .
METHODS	All surgical treatments were performed in the operating room , and all patients were reevaluated in our outpatient clinic after 10 days and again after a month .
METHODS	The primary outcome measure was the rate of infection .
RESULTS	Fifty-eight patients were initially enrolled in the study ; 2 patients withdrew before study completion , 29 subjects were randomized to the no-antibiotic group , and 27 subjects were randomized to the antibiotic group .
RESULTS	No statistically significant differences on any baseline values were found between the 2 treatment groups .
RESULTS	There was no infection in either group at the end of follow-up .
CONCLUSIONS	This study suggests that routine prophylactic antibiotics do not reduce the rate of infection after fingertip amputations with bone exposed treated surgically in the operating room .

###25452437
OBJECTIVE	Arthralgia occurs in up to 50 % of breast cancer survivors treated with aromatase inhibitors ( AIs ) and is the most common reason for poor AI adherence .
OBJECTIVE	We conducted , in 121 breast cancer survivors receiving an AI and reporting arthralgia , a yearlong randomized trial of the impact of exercise versus usual care on arthralgia severity .
METHODS	Eligibility criteria included receiving an AI for at least 6 months , reporting 3 of 10 for worst joint pain on the Brief Pain Inventory ( BPI ) , and reporting < 90 minutes per week of aerobic exercise and no strength training .
METHODS	Participants were randomly assigned to exercise ( 150 minutes per week of aerobic exercise and supervised strength training twice per week ) or usual care .
METHODS	The BPI , Western Ontario and McMaster Universities Osteoarthritis ( WOMAC ) index , and Disabilities of the Arm , Shoulder and Hand ( DASH ) questionnaire were completed at baseline and at 3 , 6 , 9 , and 12 months .
METHODS	Intervention effects were evaluated using mixed-model repeated measures analysis , with change at 12 months as the primary end point .
RESULTS	Over 12 months , women randomly assigned to exercise ( n = 61 ) attended 70 % ( standard deviation [ SD ] , 28 % ) of resistance training sessions and increased their exercise by 159 ( SD , 136 ) minutes per week .
RESULTS	Worst joint pain scores decreased by 1.6 points ( 29 % ) at 12 months among women randomly assigned to exercise versus a 0.2-point increase ( 3 % ) among those receiving usual care ( n = 60 ; P < .001 ) .
RESULTS	Pain severity and interference , as well as DASH and WOMAC pain scores , also decreased significantly at 12 months in women randomly assigned to exercise , compared with increases for those receiving usual care ( all P < .001 ) .
CONCLUSIONS	Exercise led to improvement in AI-induced arthralgia in previously inactive breast cancer survivors .

###25480344
BACKGROUND	Hyperkalemia is an infrequent but potentially serious complication of low molecular weight heparin ( LMWH ) use .
BACKGROUND	While there are a number of trials comparing LMWH to unfractionated heparin ( UFH ) there is no comparison of the risk with LMWH versus placebo .
BACKGROUND	Aim of the present post-hoc analysis of the PARAT trial was the description of serum potassium levels with certoparin compared to placebo .
RESULTS	PARAT was a double-blind , placebo-controlled , randomized trial in patients with coronary artery disease receiving either 8,000 I.U. aXa per day or placebo .
RESULTS	Serum potassium was monitored at baseline and at scheduled follow-up visits at 2 and 4-6 weeks and 3 and 4-6 months .
RESULTS	Statistical evaluation included paired , two sided t-test for each of the treatment groups to compare baseline and follow-up values .
RESULTS	A total of 117 patients ( 59 certoparin , 58 placebo ) were included with a mean age of 59 years and 84.6 % male gender .
RESULTS	There was a statistically significant increase in serum potassium at two weeks after discharge compared to baseline ( p < 0.001 ) in either group which remained elevated throughout the three months treatment phase .
RESULTS	Differences between treatment groups were not statistically significant .
RESULTS	After treatment discontinuation at the three months ' visit serum potassium returned to normal values ( p = n.s. vs. baseline ) in both groups .
RESULTS	Overall 12 out of 59 patients receiving certoparin ( 20.3 % ) and 11 out of 58 patients receiving placebo ( 19.0 % ) experienced hyperkalemia based on threshold of > 5.0 mmol/l at any time during the observation .
CONCLUSIONS	We conclude that there is no incremental risk of hyperkalemia with certoparin up to 8,000 I.U. aXa per day versus placebo in patients with coronary artery disease .
CONCLUSIONS	The increase in serum potassium values in either group calls for clinical surveillance and the consideration of further risk factors predisposing to hyperkalemia .

###24768443
BACKGROUND	Our randomized trial found no survival advantage for axillary dissection ( AD ) compared observation only ( no AD ) in older patients with early breast cancer and a clinically negative axilla , indicating that AD is unnecessary .
BACKGROUND	We compared characteristics and outcomes in out-trial patients with those in trial patients to provide indications as to whether AD can be safely omitted outside the trial setting .
METHODS	The trial started in 1996 , recruiting 238 patients age 65-80 years with cT1cN0 breast cancer , randomized to conservative surgery with or without AD .
METHODS	Over the recruitment period , 109 eligible patients who refused to participate in the trial , also received conservative breast surgery with or without AD depending on patient preference/surgeon opinion .
METHODS	Trial and out-trial patients received conventionally-fractioned whole breast radiation and tamoxifen for five years .
METHODS	Endpoints were breast cancer mortality , overall survival , and cumulative incidence of axillary disease in patients not receiving AD .
RESULTS	After 15 years of follow-up , breast cancer mortality and overall survival did not differ between the AD and no AD arms , in either the trial or out-trial cohorts .
RESULTS	The 15-year cumulative incidence of axillary relapse was 6 % in the no AD arm of the trial group , and zero in the no AD arm of the out-trial group .
CONCLUSIONS	Outside the trial setting , older patients with T1N0 breast cancer can be safely treated by conservative surgery , postoperative radiotherapy and tamoxifen for five years ( if ER-positive ) .
CONCLUSIONS	Axillary surgery is appropriate only for the small proportion of patients who develop overt axillary disease during follow-up .

###25370185
BACKGROUND	The aim of the Youth Depression Alleviation-Combined Treatment ( YoDA-C ) study is to determine whether antidepressant medication should be started as a first-line treatment for youth depression delivered concurrently with psychotherapy .
BACKGROUND	Doubts about the use of medication have been raised by meta-analyses in which the efficacy and safety of antidepressants in young people have been questioned , and subsequent treatment guidelines for youth depression have provided only qualified support .
METHODS	YoDA-C is a double-blind , randomised controlled trial funded by the Australian government 's National Health and Medical Research Council .
METHODS	Participants between the ages of 15 and 25 years with moderate to severe major depressive disorder will be randomised to receive either ( 1 ) cognitive behavioural therapy ( CBT ) and fluoxetine or ( 2 ) CBT and placebo .
METHODS	The treatment duration will be 12 weeks , and follow-up will be conducted at 26 weeks .
METHODS	The primary outcome measure is change in the Montgomery-sberg Depression Rating Scale ( MADRS ) after 12 weeks of treatment .
METHODS	The MADRS will be administered at baseline and at weeks 4 , 8 , 12 and 26 .
METHODS	Secondary outcome measures will address additional clinical outcomes , functioning , quality of life and safety .
BACKGROUND	Australian and New Zealand Clinical Trials Registry ID : ACTRN12612001281886 ( registered on 11 December 2012 ) .

###24495682
OBJECTIVE	To investigates factors affecting the positive rate of blocking antibody treated by paternal lymphocyte immunotherapy in patients with recurrent spontaneous abortion ( RSA ) .
METHODS	From January 2008 to August 2012 , 326 RSA cases undergoing treatment in Infertility Center of Qilu Hospital were studied retrospectively .
METHODS	Those patients were divided into 2 groups randomly : 260 cases in intradermal injection group were administered via bilateral forearm intradermal injections for immunotherapy once 21 days , then the blocking antibody was determined after 2 ( 23 cases ) , 3 ( 73 cases ) , 4 ( 74 cases ) , 5 ( 90 cases ) times respectively , while in subcutaneous injection group , the 66 cases were administered via subcutaneous injection once 21 days , the blocking antibody measured after 3 times ; In both cases , the blocking antibody was all determined 2 weeks later .
METHODS	The positive rate of blocking antibodies and the rate of successful pregnancy was recorded , and then followed up after the blocking antibody turning positive .
RESULTS	( 1 ) Positive rate of blocking antibodies : the positive rate of blocking antibodies were 17 % ( 4/23 ) , 58 % ( 42/73 ) , 72 % ( 53/74 ) and 84 % ( 76/90 ) in the 2 , 3 , 4 , and 5 times of intradermal injection group , respectively ( P < 0.05 ) .
RESULTS	In subcutaneous injection group , the positive rate of blocking antibodies was 38 % ( 25/66 ) , which was significantly lower than that in group intradermal injection receiving 3 times immunotherapy ( P < 0.05 ) .
RESULTS	( 2 ) The rate of pregnancy : the 176 patients out of 200 patients were pregnant when antibody was positive after immunotherapy , with 71.6 % ( 126/176 ) of patients gained successful pregnancy ( the length of pregnancy more than 5 months ) .
CONCLUSIONS	The route and frequency of administration of immunotherapy could influence the positive rate of blocking antibody .
CONCLUSIONS	The rate of successful pregnancy will be increased after blocking antibody turning positive .

###24385632
OBJECTIVE	The current study examined a 5-year cognitive change in untrained African American and White participants from the Advanced Cognitive Training in Independent and Vital Elderly ( ACTIVE ) study .
METHODS	Five-year trajectories of memory , reasoning , visual processing speed/useful field of view , digit-symbol substitution , and vocabulary were investigated .
METHODS	Education , health , gender , age , and retest/practice effects were controlled for , and a missing data pattern mixture approach was used to adjust for dropout effects .
RESULTS	After considering age , education , health , and gender , being African American uniquely explained 2 % to 7 % of the variance in cognitive performance .
RESULTS	There were virtually no significant race differences in the rates of change .
CONCLUSIONS	Race-related results in the current study are consistent with previous research suggesting that social advantage factors such as education have a stronger influence on the level of performance than the rate of change .
CONCLUSIONS	The small remaining effects of being African American on performance levels likely reflect uncontrolled variation in factors like literacy and financial advantage .

###24796764
OBJECTIVE	To determine the optimal infertility therapy for women at the end of their reproductive potential .
METHODS	Randomized clinical trial .
METHODS	Academic medical centers and private infertility center in a state with mandated insurance coverage .
METHODS	Couples with 6 months of unexplained infertility ; female partner aged 38-42 years .
METHODS	Randomized to treatment with two cycles of clomiphene citrate ( CC ) and intrauterine insemination ( IUI ) , follicle stimulating hormone ( FSH ) / IUI , or immediate IVF , followed by IVF if not pregnant .
METHODS	Proportion with a clinically recognized pregnancy , number of treatment cycles , and time to conception after two treatment cycles and at the end of treatment .
RESULTS	We randomized 154 couples to receive CC/IUI ( N = 51 ) , FSH/IUI ( N = 52 ) , or immediate IVF ( N = 51 ) ; 140 ( 90.9 % ) couples initiated treatment .
RESULTS	The cumulative clinical pregnancy rates per couple after the first two cycles of CC/IUI , FSH/IUI , or immediate IVF were 21.6 % , 17.3 % , and 49.0 % , respectively .
RESULTS	After all treatments , 110 ( 71.4 % ) of 154 couples had conceived a clinically recognized pregnancy , and 46.1 % had delivered at least one live-born baby ; 84.2 % of all live-born infants resulting from treatment were achieved via IVF .
RESULTS	There were 36 % fewer treatment cycles in the IVF arm compared with either COH/IUI arm , and the couples conceived a pregnancy leading to a live birth after fewer treatment cycles .
CONCLUSIONS	A randomized controlled trial in older women with unexplained infertility to compare treatment initiated with two cycles of controlled ovarian hyperstimulation/IUI versus immediate IVF demonstrated superior pregnancy rates with fewer treatment cycles in the immediate IVF group .
BACKGROUND	NCT00246506 .

###25693990
BACKGROUND	Grades are commonly used in formative workplace-based assessment ( WBA ) in medical education and training , but may draw attention away from feedback about the task .
BACKGROUND	A dilemma arises because the self-regulatory focus of a trainee must include self-awareness relative to agreed standards , which implies grading .
OBJECTIVE	In this study we aimed to understand the meaning which medical students construct from WBA feedback with and without grades , and what influences this .
METHODS	Year 3 students were invited to take part in a randomised crossover study in which each student served as his or her own control .
METHODS	Each student undertook one WBA with and one without grades , and then chose whether or not to be given grades in a third WBA .
METHODS	These preferences were explored in semi-structured interviews .
METHODS	A realist approach to analysis was used to gain understanding of student preferences and the impact of feedback with and without grades .
RESULTS	Of 83 students who were given feedback with and without grades , 65 ( 78 % ) then chose to have feedback with grades and 18 ( 22 % ) without grades in their third WBA .
RESULTS	A total of 24 students were interviewed .
RESULTS	Students described how grades locate their performance and calibrate their self-assessment .
RESULTS	For some , low grades focused attention and effort .
RESULTS	Satisfactory and high grades enhanced self-efficacy .
CONCLUSIONS	Grades are concrete , powerful and blunt , can be harmful and need to be explained to help students create helpful meaning from them .
CONCLUSIONS	Low grades risk reducing self-efficacy in some and may encourage others to focus on proving their ability rather than on improvement .
CONCLUSIONS	A metaphor of the semi-permeable membrane is introduced to elucidate how students reduced potential negative effects and enhanced the positive effects of feedback with grades by selective filtering and pumping .
CONCLUSIONS	This study illuminates the complexity of the processing of feedback by its recipients , and informs the use of grading in the provision of more effective , tailored feedback .

###25176628
OBJECTIVE	Sedation with propofol should be administered by personnel trained in advanced airway management .
OBJECTIVE	To overcome this limitation , the use of short acting benzodiazepines by cardiologists spread widely , causing concerns about the safety of this procedure in the absence of anesthesiology assistance .
OBJECTIVE	The aim of the study was to compare feasibility of a cardiologist-only approach with an anesthesiologist-assisted sedation protocol during elective direct-current cardioversion ( DCC ) of persistent atrial fibrillation ( AF ) .
METHODS	This prospective , open-blinded , randomized study included 204 patients , which were admitted for scheduled cardioversion of persistent AF , and randomized in a 1:1 fashion to either propofol or midazolam treatment arm .
METHODS	Patients in the propofol group underwent DCC with anesthesiologist assistance , while patients in the midazolam group saw the cardiologist as the only responsible for both sedation and DCC .
RESULTS	Twenty-three adverse events occurred : 13 in the propofol group and 10 in the midazolam group ( p = NS ) .
RESULTS	Most of them were related to bradyarrhythmias and respiratory depressions .
RESULTS	There was no need of intubation or other advanced resuscitation techniques in any of these patients .
RESULTS	No differences were found regarding procedure tolerability and safety endpoints between the two groups .
RESULTS	DCC procedures with anesthesiology support were burdened by higher delay from scheduled time and higher costs .
CONCLUSIONS	Sedation with midazolam administered by cardiologist-only appears to be as safe as sedation with propofol and anesthesiologist assistance .
CONCLUSIONS	Adverse events were few in both groups and easily handled by the cardiologist alone .
CONCLUSIONS	A cardiologist-only approach to sedation provides less procedural delay , thus being easier to schedule and correlated with fewer costs .

###24447354
OBJECTIVE	To investigate the effect of low molecular heparin on degree of severity and prognosis of severe pneumonia in elderly patients .
METHODS	A prospective randomized control study was conducted .
METHODS	During October 2009 to July 2013 , 63 patients over 65 years old and suffering from severe pneumonia were enrolled .
METHODS	Patients were grouped into control or treatment group randomly .
METHODS	The control group ( n = 36 ) received routine treatment , while low molecular heparin 4 kU once a day was added in treatment group ( n = 39 ) for 7 days .
METHODS	Acute physiology and chronic health evaluationII ( APACHEII ) score , coagulation function indexes , blood gas analysis , arterial lactic acid at 1 , 3 , 7 days after treatment , and length of mechanical ventilation , days of stay in ICU , and 7-day mortality were compared between both groups .
RESULTS	The basic data and APACHEII score had no difference between two groups ( all P > 0.05 ) .
RESULTS	Bleeding events occurred on day 1 , 3 , 7 in 1 , 1 , 2 patients in control group , respectively , and 0 , 1 , 3 cases in treatment group .
RESULTS	There was no difference in APACHEII score on day 1 and day 3 between control group and treatment group ( 1 day : 19.33 5.90 vs. 20.31 4.97 , t = 0.775 , P = 0.441 ; 3 days : 18.69 4.88 vs. 17.41 3.83 , t = 1.272 , P = 0.207 ) .
RESULTS	APACHEII score on day 7 in treatment group was significantly lower than that in control group ( 13.92 3.61 vs. 16.20 4.23 , t = 2.480 , P = 0.016 ) .
RESULTS	There was no significant difference in coagulation function indexes during observation period between two groups ( all P > 0.05 ) .
RESULTS	The blood gas analysis showed that only arterial partial pressure of oxygen ( PaO2 ) 7 days after treatment in treatment group was significantly higher than that in control group ( 110.52 28.57 mm Hg vs. 95.47 24.17 mm Hg , t = -2.354 , P = 0.022 ) .
RESULTS	There was no significant difference in 7-day mortality between two groups .
RESULTS	The mechanical ventilation time in treatment group was slightly shorter than that in control group ( 147.45 111.45 hours vs. 192.20 115.57 hours , t = 1.704 , P = 0.093 ) .
RESULTS	The length of stay in ICU in treatment group was significantly shorter than that in control group ( 13.77 5.77 days vs. 17.22 6.21 days , t = 2.497 , P = 0.015 ) .
CONCLUSIONS	In elderly patients suffering from severe pneumonia , low molecular heparin may reduce APACHEII score , shorten mechanical ventilation time and length of ICU stay , and the prognosis may be improved .

###24598116
BACKGROUND	Nasal douching is commonly performed after endoscopic sinus surgery ( ESS ) .
BACKGROUND	There is a lack of studies comparing the clinical effect of various douching solutions after ESS .
BACKGROUND	This study investigated the clinical effects of normal saline , lactated Ringer 's , and hypertonic saline nasal douching solutions after ESS .
METHODS	Adult patients ( 41.8 12.9 years ) undergoing bilateral ESS for chronic rhinosinusitis at a single tertiary referral center were blindly randomized to one of the three study solutions and reviewed on postoperative weeks 1 , 3 , and 6 .
METHODS	The 20-item Sino-Nasal Outcome Test ( SNOT-20 ) scores , visual analog scale ( VAS ) symptom scores , digital video capture of the sinus cavities , and mucociliary clearance ( MCC ) times were performed at each visit .
METHODS	The mucosa appearances were scored by a second investigator , blinded to the douching solution .
RESULTS	Seventy-four patients were recruited .
RESULTS	All groups showed an improvement with treatment in SNOT-20 scores and VAS scores , as well as endoscopic evaluation of mucosa appearance over time .
RESULTS	There was no improvement of MCC during the treatment period .
RESULTS	Irrigation with lactated Ringer 's solution resulted in better symptom scores in SNOT-20 ( p < 0.05 ) and VAS ( p < 0.05 ) , compared with irrigation with normal saline or hypertonic saline solutions .
RESULTS	Patients receiving hypertonic saline solutions had less polypoidal mucosa at week 6 .
CONCLUSIONS	Douching with lactated Ringer 's solution after ESS results in better improvement in sinonasal symptoms , compared with normal saline or hypertonic saline solutions .

###25097192
BACKGROUND	Previous studies have shown that the injection of dehydrated alcohol has been successful for the treatment of Morton 's neuroma in the foot .
BACKGROUND	In this study , we determined the cellular effect of injection of alcohol into and around the sciatic nerve of rats and measured the extent of cell necrosis and/or any associated histologic or inflammatory changes .
METHODS	Twenty-two male ( ~ 375 g ) Wistar rats were randomized into 2 groups each receiving alcohol injections into or around the sciatic nerve after nerve exposure under sterile technique .
METHODS	Group 1 rats were injected with a 0.5 ml solution of 0.5 % Marcaine in the left sciatic nerve as a control group .
METHODS	In the right sciatic nerve a 0.5 ml solution of 4 % ethanol with 0.5 % Marcaine was injected .
METHODS	Group 2 rats received 0.5 ml of 20 % ethanol with 0.5 % Marcaine injected into the left sciatic nerve and 0.5 ml of 30 % ethanol with 0.5 % Marcaine injected into the right sciatic nerve .
METHODS	In each group , the rats were placed in 3 subgroups : intraneural , perineural , perimuscular injections .
METHODS	All rats were sacrificed and tissue harvested for histologic evaluation at day 10 post injection .
RESULTS	No evidence of alcohol-associated cell necrosis , apoptosis , or apparent inflammation was observed in histologic specimens of any injected nerves , perineural tissue , or muscles in controls or experimental groups regardless of concentration of ethanol injected on day 10 .
CONCLUSIONS	We concluded that alcohol injection ( 30 % ethanol ) into and/or around the sciatic nerve or the adjacent muscle of rats has no histologic evidence of necrosis or inflammation to the nerve or surrounding tissue .
CONCLUSIONS	There was no observable histological change in apoptosis , or cell number , in response to the alcohol injection .
CONCLUSIONS	The lack of any measureable changes in nerve or adjacent muscle histology with ethanol injection into the rat sciatic nerve ( and surrounding tissues ) raises questions about the efficacy of using ethanol injections in the treatment of Morton 's neuroma in human clinical practice .

###25540069
BACKGROUND	Laparoscopic cholecystectomy frequently results in significant immediate postoperative pain .
BACKGROUND	A new pain monitor , analgesic nociception index ( ANI ) , based on heart rate variability , has recently been approved for intraoperative nociception monitoring .
BACKGROUND	We designed a single-blind , parallel-group , randomized control trial to test the hypothesis that protocol-driven intraoperative analgesia guided by ANI during laparoscopic cholecystectomy would improve titration of intraoperative analgesics leading to decreased postoperative pain .
METHODS	One hundred and twenty consecutive adult participants presenting for elective laparoscopic cholecystectomy were recruited .
METHODS	Participants were randomly allocated by sealed envelope to receive intraoperative morphine either guided by ANI via a protocol ( intervention group ) or guided by the anaesthetist with ANI concealed ( control group ) .
METHODS	All participants received paracetamol , parecoxib , fentanyl at induction , and local anaesthetic to port sites .
METHODS	The primary endpoint was the presence of moderate/severe pain ( visual analogue scale 50 mm ) at any of the four time points in the first postoperative hour .
METHODS	Secondary endpoints included postoperative rescue morphine .
RESULTS	Sixty participants were randomized to each group , and all but one drop-out from the intervention group were analysed .
RESULTS	The usage of ANI guidance did not result in a decrease in the rate of moderate/severe pain ( 50.8 % vs 45.0 % : difference of -5.8 % , 95 % confidence interval , -23.7 % to 12.1 % , P = 0.58 ) , or the use of postoperative rescue analgesia .
CONCLUSIONS	This randomized control trial of intraoperative ANI-guided morphine administration in elective laparoscopic cholecystectomy failed to show any advantage over the current standard of care , and demonstrated a high level of postoperative pain , despite the use of multimodal analgesia .
BACKGROUND	ANZCTR Reference ACTRN12612000953831 ( URL : http://www.anzctr.org.au/trial_view.aspx?ID=362949 ) .

###25924490
OBJECTIVE	To compare the therapeutic effects between anatomical locked plate combined with coracoclavicular ligament reconstruction and clavicular hook plate for treatment of distal clavicle fracture of Neer type II b.
METHODS	From August 2010 to August 2013 , 42 patients with Neer II b distal clavicle fractures were randomly divided into two groups as group A and group B.
METHODS	In group A , there were 22 cases including 14 males and 8 females with an average age of ( 44.211.6 ) years old .
METHODS	In group B , there were 20 cases including 11 males and 9 females with an average of ( 45.612.4 ) years old .
METHODS	The patients of group A were treated with anatomical locked plate combined with coracoclavicular ligament reconstruction , the patients of group B were treated with hook plate .
METHODS	All fractures were fresh , the time between injuries and operation was 24 hours to 7 days ( mean ,72 h ) .
METHODS	General information between the two groups was comparable before operation ( P > 0.05 ) .
METHODS	Postoperative radiographic were followed up to observe the fracture healing , internal fixation and to measure coracoclavicular distance of two groups .
METHODS	Shoulder function after operation was evaluated by Constant-Murley score system .
RESULTS	All patients were followed up with an average of 16.8 months ( ranging 12 to 24 months ) .
RESULTS	There was no nonunion , infection and other complications between two groups .
RESULTS	The clavicular stress fracture occurred in 1 clavicular hook patient at 6 months after the operation .
RESULTS	According to the Constant-Murley score system , that the scores of group A were 90.66.2 , 91.84.8 , 94.73.6 and 97.81.2 at 1st , 3rd , 6 month and last follow-up after operation were higher than those of group B 74.83.4 , 78.44.4 , 82.22.8 and 94.63.6 ( P 0.05 ) .
RESULTS	The fracture healing time of group A ( 21.62.2 ) weeks was shorter than that of group B ( 25.82.5 ) weeks ( P 0.05 ) .
RESULTS	There were no statistically significant differences between two groups in coracoclavicular distance at last follow-up ( P > 0.05 ) .
CONCLUSIONS	The anatomical locked plate combined with coracoclavicular ligament reconstruction need not expose shoulder and can reduce the incidence of postoperative pain and limited activity of shoulder , with fewer complication , it is advantageous to the shoulder joint function early recovery .

###25230684
BACKGROUND	Virtual patient simulation has grown substantially in health care education .
BACKGROUND	A virtual patient simulation was developed as a refresher training course to reinforce nursing clinical performance in assessing and managing deteriorating patients .
OBJECTIVE	The objective of this study was to describe the development of the virtual patient simulation and evaluate its efficacy , by comparing with a conventional mannequin-based simulation , for improving the nursing students ' performances in assessing and managing patients with clinical deterioration .
METHODS	A randomized controlled study was conducted with 57 third-year nursing students who were recruited through email .
METHODS	After a baseline evaluation of all participants ' clinical performance in a simulated environment , the experimental group received a 2-hour fully automated virtual patient simulation while the control group received 2-hour facilitator-led mannequin-based simulation training .
METHODS	All participants were then re-tested one day ( first posttest ) and 2.5 months ( second posttest ) after the intervention .
METHODS	The participants from the experimental group completed a survey to evaluate their learning experiences with the newly developed virtual patient simulation .
RESULTS	Compared to their baseline scores , both experimental and control groups demonstrated significant improvements ( P < .001 ) in first and second post-test scores .
RESULTS	While the experimental group had significantly lower ( P < .05 ) second post-test scores compared with the first post-test scores , no significant difference ( P = .94 ) was found between these two scores for the control group .
RESULTS	The scores between groups did not differ significantly over time ( P = .17 ) .
RESULTS	The virtual patient simulation was rated positively .
CONCLUSIONS	A virtual patient simulation for a refreshing training course on assessing and managing clinical deterioration was developed .
CONCLUSIONS	Although the randomized controlled study did not show that the virtual patient simulation was superior to mannequin-based simulation , both simulations have demonstrated to be effective refresher learning strategies for improving nursing students ' clinical performance .
CONCLUSIONS	Given the greater resource requirements of mannequin-based simulation , the virtual patient simulation provides a more promising alternative learning strategy to mitigate the decay of clinical performance over time .

###26187233
BACKGROUND	Caloric restriction ( CR ) , energy intake reduced below ad libitum ( AL ) intake , increases life span in many species .
BACKGROUND	The implications for humans can be clarified by randomized controlled trials of CR .
METHODS	To determine CR 's feasibility , safety , and effects on predictors of longevity , disease risk factors , and quality of life in nonobese humans aged 21-51 years , 218 persons were randomized to a 2-year intervention designed to achieve 25 % CR or to AL diet .
METHODS	Outcomes were change from baseline resting metabolic rate adjusted for weight change ( `` RMR residual '' ) and core temperature ( primary ) ; plasma triiodothyronine ( T3 ) and tumor necrosis factor - ( secondary ) ; and exploratory physiological and psychological measures .
RESULTS	Body mass index averaged 25.1 ( range : 21.9-28 .0 kg/m ( 2 ) ) .
RESULTS	Eighty-two percent of CR and 95 % of AL participants completed the protocol .
RESULTS	The CR group achieved 11.70.7 % CR ( mean standard error ) and maintained 10.40.4 % weight loss .
RESULTS	Weight change in AL was negligible .
RESULTS	RMR residual decreased significantly more in CR than AL at 12 months ( p = .04 ) but not 24 months ( M24 ) .
RESULTS	Core temperature change differed little between groups .
RESULTS	T3 decreased more in CR at M12 and M24 ( p < .001 ) , while tumor necrosis factor - decreased significantly more only at M24 ( p = .02 ) .
RESULTS	CR had larger decreases in cardiometabolic risk factors and in daily energy expenditure adjusted for weight change , without adverse effects on quality of life .
CONCLUSIONS	Sustained CR is feasible in nonobese humans .
CONCLUSIONS	The effects of the achieved CR on correlates of human survival and disease risk factors suggest potential benefits for aging-related outcomes that could be elucidated by further human studies .

###24636808
BACKGROUND	Although scientific knowledge about the benefits of probiotic use in cystis fibrosis ( CF ) is scarce , their expectative is promising .
BACKGROUND	The aim of this work was to analyze the effect of a Lactobacillus reuteri probiotic preparation versus placebo in CF patients .
METHODS	A prospective , double blind , crossover and with placebo study was carried out in 30 CF patients from two Spanish hospitals .
METHODS	Patients were randomized in Group A ( 6 months of probiotic followed by 6 months of placebo ) and Group B ( 6 months of placebo followed by 6 months of probiotic ) .
METHODS	GIQLI ( gastrointestinal ) and SF-12 ( general ) health tests were performed after probiotic and placebo intakes .
METHODS	Fat absorption coefficient , calprotectin , and inflammatory interleukin quantification were determined in fecal samples .
METHODS	Total fecal DNA was obtained and metagenomic 454-pyrosequencing was applied to analyze the microbiome composition .
METHODS	STATA v12 MP software was used for statistical analyses .
RESULTS	Statistically significant improvement in the gastrointestinal health and decrease of the calprotectin levels were demonstrated in patients after probiotic exposure , in comparison with placebo .
RESULTS	All CF subjects reported good tolerance to L. reuteri without secondary effects .
RESULTS	Metagenomic analysis showed an important dysbiosis in CF gut microbiota associated with a high concentration of Proteobacteria .
RESULTS	Probiotic intake was followed by a reduction in the total bacterial density , mostly due to a considerable reduction in the - Proteobacteria phylum ; and an important increase of the microbial diversity with a higher representation of Firmicutes .
CONCLUSIONS	Probiotics might ameliorate the dysbiosis of CF gut microbiota , characterized by a high density of Proteobacterial organisms .
CONCLUSIONS	L. reuteri significantly decrease intestinal inflammation and increase digestive comfort .

###25636947
BACKGROUND	The magnitude of effect of sublingual immunotherapy for house dust mite ( HDM ) - induced allergic rhinitis with or without conjunctivitis is uncertain , partly because there are few well-controlled trials with well-defined doses .
OBJECTIVE	We sought to determine the dose-related efficacy and onset of action of the HDM sublingual immunotherapy tablet MK-8237 ( Merck/ALK-Abell ) using the Vienna Challenge Chamber .
METHODS	In this randomized , double-blind , single-site trial , adults with HDM-induced allergic rhinitis with or without conjunctivitis and with or without asthma ( n = 124 ) received 12 developmental units ( DU ) of MK-8237 , 6 DU of MK-8237 , or placebo daily for 24 weeks .
METHODS	Subjects underwent 6-hour exposure challenges at screening and weeks 8 , 16 , and 24 .
METHODS	The total nasal symptom score ( TNSS ) during chamber challenge at week 24 was the primary end point .
METHODS	The TNSS was the sum of 4 nasal symptom scores ( maximum = 12 ) .
METHODS	Total ocular symptom scores ( TOSSs ; 2 symptoms ; maximum = 6 ) and total symptom scores ( TSSs ; TSS = TNSS plus TOSS ; maximum = 18 ) were secondary end points .
RESULTS	Dose - and time-dependent improvements with MK-8237 versus placebo were observed .
RESULTS	At week 24 , TNSS improvement relative to placebo was 48.6 % ( 95 % CI , 35.3 % to 60.2 % ) with 12 DU of MK-8237 and 26.6 % ( 95 % CI , 11.2 % to 39.6 % ) with 6 DU of MK-8237 .
RESULTS	Statistically significant improvements for TNSSs were also observed at weeks 8 ( 12 DU of MK-8237 ) and 16 ( 6 and 12 DU of MK-8237 ) and for TOSSs and TSSs by both doses at week 24 .
RESULTS	MK-8237 was well tolerated .
RESULTS	No investigator-assessed anaphylactic allergic reactions or reactions requiring epinephrine were observed .
CONCLUSIONS	MK-8237 , 12 DU , reduced nasal and ocular symptoms and exceeded World Allergy Organization-established clinical efficacy criteria ( 20 % improvement vs placebo ) .
CONCLUSIONS	The onset of action for 12 DU of MK-8237 was week8.MK-8237 , 12 DU , is appropriate for further evaluation to determine the magnitude of effect in an uncontrolled allergenexposure environment .

###24761898
BACKGROUND	Oesophageal cancer presents high incidence rates in the so-called Brazilian-Uruguayan belt .
METHODS	The present study included 1,170 participants ( 234 cases and 936 controls ) which were analyzed by unconditional multiple logistic regression in order to examine risk of oesophageal squamous cell carcinoma ( OESCC ) associated with several food groups .
RESULTS	Boiled red meat ( OR 2.59 , 95 % CI 1.69-3 .97 ) , lamb meat ( OR 1.64 , 95 % CI 1.07-2 .51 ) , processed meat ( OR 1.49 , 95 % CI 1.01-2 .21 ) , whole milk ( OR 1.78 , 1.19-1 .68 ) , fresh vegetables and fruits ( OR 0.42 , 95 % CI 0.27-0 .63 ) , mate consumption ( OR 2.04 , 95 % CI 1.32 - 3.16 ) , and black tea ( OR 0.10 , 95 % CI 0.04-0 .28 ) were significantly associated with risk of OESCC .
CONCLUSIONS	Hot beverages ( mate ) and hot foods ( boiled meat ) appear to be important determinants in the risk of OESCC , allowing the penetration of carcinogens in tobacco and alcohol into the oesophageal mucosa .

###25300273
BACKGROUND	Despite the growing interest in the early-origins-of-later-disease hypothesis , little is known about the metabolic underpinnings linking infant weight gain and childhood obesity .
OBJECTIVE	To discover biomarkers reflective of weight change in the first 6 months and overweight/obesity at age 6 years via a targeted metabolomics approach .
METHODS	This analysis comprised 726 infants from a European multicenter randomized trial ( Childhood Obesity Programme , CHOP ) for whom plasma blood samples at age 6 months and anthropometric data up to the age of 6 years were available .
METHODS	` Rapid growth ' was defined as a positive difference in weight within the first 6 months of life standardized to WHO growth standards .
METHODS	Weight change was regressed on each of 168 metabolites ( acylcarnitines , lysophosphatidylcholines , sphingomyelins , and amino acids ) .
METHODS	Metabolites significant after Bonferroni 's correction were tested as predictors of later overweight/obesity .
RESULTS	Among the overall 19 significant metabolites , 4 were associated with rapid growth and 15 were associated with a less-than-ideal weight change .
RESULTS	After adjusting for feeding group , only the lysophosphatidylcholine LPCaC14 :0 remained significantly associated with rapid weight gain ( = 0.18 ) .
RESULTS	Only LPCaC14 :0 at age 6 months was predictive of overweight/obesity at age 6 years ( OR 1.33 ; 95 % CI 1.04-1 .69 ) .
CONCLUSIONS	LPCa14 :0 is strongly related to rapid growth in infancy and childhood overweight/obesity .
CONCLUSIONS	This suggests that LPCaC14 :0 levels may represent a metabolically programmed effect of infant weight gain on the later obesity risk .
CONCLUSIONS	However , these results require confirmation by independent cohorts .

###24674962
OBJECTIVE	To study the clinical effectiveness of biofeedback treatment in reducing tics in patients with Tourette syndrome .
BACKGROUND	Despite advances in the pharmacologic treatment of patients with Tourette syndrome , many remain troubled by their tics , which may be resistant to multiple medications at tolerable doses .
BACKGROUND	Electrodermal biofeedback is a noninvasive biobehavioral intervention that can be useful in managing neuropsychiatric and neurologic conditions .
METHODS	We conducted a randomized controlled trial of electrodermal biofeedback training in 21 patients with Tourette syndrome .
RESULTS	After training the patients for 3 sessions a week over 4 weeks , we observed a significant reduction in tic frequency and improved indices of subjective well-being in both the active-biofeedback and sham-feedback ( control ) groups , but there was no difference between the groups in these measurements .
RESULTS	Furthermore , the active-treatment group did not demonstrably learn to reduce their sympathetic electrodermal tone using biofeedback .
CONCLUSIONS	Our findings indicate that this form of biofeedback training was unable to produce a clinical effect greater than placebo .
CONCLUSIONS	The main confounding factor appeared to be the 30-minute duration of the training sessions , which made it difficult for patients to sustain a reduction in sympathetic tone when their tics themselves were generating competing phasic electrodermal arousal responses .
CONCLUSIONS	Despite a negative finding in this study , electrodermal biofeedback training may have a role in managing tics if optimal training schedules can be identified .

###24479280
OBJECTIVE	To measure the pH , titratable acidity , fluoride concentration and erosive potential of brewed teas .
METHODS	Bag teas were purchased to represent black , green , citrus , fruity , and floral tea flavors from Tulsi , Bigelow , HyVee , Tazo , and Yogi brands and brewed ( 1 bag/240 ml ) in boiling water for 3 minutes .
METHODS	The pH , titratable acidity , and fluoride concentrations were measured .
METHODS	Following these measurements , a representative tea from each flavor was selected for investigation of erosion potential .
METHODS	Six extracted human molars were randomly assigned to each tea .
METHODS	Teeth were painted with fingernail polish to expose a 1 x 4 mm window and then soaked in tea for a total of 25 hours with teas refreshed every 5 hours .
METHODS	Teeth were then sectioned using a microtome and photographed using a polarized light microscope .
METHODS	Lesion depths ( i.e. , eroded surfaces ) were measured using Image Pro Plus software .
METHODS	Differences in physiochemical properties and lesion depths between beverages were investigated using one-way ANOVA with post-hoc Tukey 's HSD test .
METHODS	Relationships among lesion depths and physiochemical properties were evaluated using the Pearson correlation test .
RESULTS	pH , titratable acidity and fluoride concentrations differed between tea flavors ( P < 0.05 ) and between brands ( P < 0.05 ) .
RESULTS	Lesion depths produced by the citrus tea ( 83.1 + / - 10.3 microm ) were greater than those produced by the fruity tea ( 56.5 + / - 6.1 microm ) ; both teas produced greater depths than black ( 30.1 + / - 7.4 microm ) , floral ( 25.0 + / - 3.2 microm ) or green ( 22.3 + / - 6.3 microm ) teas ( P < 0.05 ) .
RESULTS	pH ( r = -0.96 ; P = 0.009 ) was inversely and titratable acidity ( r = 0.97 ; P = 0.006 ) was positively associated with lesion depths .

###25211663
BACKGROUND	Anti-HER2 / neu therapy is well-established in breast and gastric carcinoma .
BACKGROUND	The increased understanding of this pathway led to the identification of new promising drugs in addition to trastuzumab , offering further perspectives .
BACKGROUND	The role of HER2/neu in colorectal carcinoma is controversially discussed , as discrepant data has been reported .
METHODS	Here , we retrospectively assessed the prevalence of HER2/neu positivity in a large series of colorectal carcinoma , testing HER2/neu status according to current recommendations .
METHODS	We correlated the results to clinico-pathological data and patient survival .
RESULTS	Overall , in 1645 primary colorectal carcinoma cases , 1.6 % of the cases were HER2/neu positive .
RESULTS	HER2/neu positivity significantly correlated with higher UICC stages ( P = 0.017 ) and lymph node metastases ( P = 0.029 ) .
RESULTS	In the subgroup of sigmoideal and rectal carcinomas , positive HER2/neu status was associated with T-category ( P = 0.041 ) and higher UICC stages ( P = 0.022 ) .
RESULTS	Although statistically not significant , HER2/neu-positive colorectal carcinomas displayed a tendency to poorer overall survival .
CONCLUSIONS	These results illustrate the importance of testing HER2/neu by approved diagnostic techniques and scoring systems .
CONCLUSIONS	We assume that although the prevalence of HER2/neu positivity in colorectal carcinoma is low , HER2/neu testing in advanced , nodal-positive colorectal carcinoma is reasonable , offering a potential target in high risk colorectal carcinoma .

###24952837
OBJECTIVE	After stroke , does treadmill training provide greater benefit to the subgroup of community-dwelling people who walk faster than 0.4 m/s than those who walk more slowly ?
METHODS	Subgroup analysis of a randomised trial : the AMBULATE trial .
METHODS	68 people with stroke living in the community .
METHODS	The experimental group received 30 minutes of treadmill and overground walking , three times a week for four months ; the control group received no intervention .
METHODS	The primary outcome was walking distance covered during the six-minute walk test .
METHODS	Other outcomes were comfortable and fast walking speed and health status .
RESULTS	At four months , in the subgroup of participants with a baseline comfortable walking speed of > 0.4 m/s , treadmill training produced an extra distance of 72m ( 95 % CI 23 to 121 ) and an increased comfortable speed of 0.16 m/s ( 95 % CI 0.00 to 0.32 ) , compared with the subgroup with a speed of 0.4 m/s .
RESULTS	There was also a trend towards an extra fast speed of 0.17 m/s ( 95 % CI -0.04 to 0.36 ) .
RESULTS	There was no extra effect of treadmill training in the faster walkers in terms of EuroQol 5Q-5D .
RESULTS	There were no differences between the experimental and control groups between subgroups in the long term .
CONCLUSIONS	Treadmill training is more likely to benefit people who walk at a speed of > 0.4 m/s .
CONCLUSIONS	Clinicians should use comfortable walking speed to predict the potential for improvement and to guide intervention .
BACKGROUND	ACTRN12607000227493 .

###24887686
BACKGROUND	No study has investigated whether pioglitazone ( an agonist of peroxisome proliferator-activated receptor gamma ) protects against ischemia and reperfusion ( IR ) - induced endothelial dysfunction in humans .
RESULTS	In the first crossover study , 20 volunteers were randomized to 1 week of pioglitazone ( 30 mg/d , postoperatively ) or control ( no treatment ) .
RESULTS	In the second single-arm study , 15 volunteers received pioglitazone and the cyclooxygenase-2 inhibitor meloxicam for 1 week .
RESULTS	On day 7 , endothelium-dependent flow-mediated dilation ( FMD ) of the distal brachial artery was measured before and after IR ( 15 minutes of ischemia followed by 15 minutes of reperfusion in the proximal upper arm ) .
RESULTS	Pre-IR brachial-artery diameter and FMD were similar across the 2 sessions ( control , pioglitazone ) in protocol 1 and between the 2 protocols .
RESULTS	IR significantly blunted FMD after no treatment ( pre-IR FMD : 10.2 % 2.6 % ; post-IR FMD : 3.5 % 1.9 % , P < 0.01 ) but not after pioglitazone administration ( pre-IR FMD : 9.7 % 2.5 % ; post-IR FMD : 8.8 % 2.9 % , P = 0.11 ) .
RESULTS	This protective effect was accompanied by an increase in serum levels of the antioxidant enzyme extracellular superoxide dismutase and was not affected by concomitant administration of the cyclooxygenase-2 inhibitor meloxicam ( P = 0.10 ) .
CONCLUSIONS	In humans , pioglitazone provides potent protection against IR-induced endothelial dysfunction .

###25391431
BACKGROUND	Vascular cognitive impairment , no dementia ( VCIND ) is a condition at risk for future dementia and should be the target of preventive strategies .
BACKGROUND	Preliminary evidence suggests that acupuncture may be a clinically effective intervention for people with early-stage vascular cognitive impairment .
BACKGROUND	We will do a multicenter , 6-month , drug-controlled , nonblinded , randomized , parallel-group trial to determine whether acupuncture is effective for improving cognitive function and quality of life for patients with VCIND .
METHODS	A total of 216 eligible patients will be recruited and randomly assigned acupuncture for two sessions/week ( n = 108 ) or citicoline 300 mg/day ( n = 108 ) in a multicenter , 6-month trial .
METHODS	The primary endpoint is cognition ( Alzheimer 's Disease Assessment Scale , Cognitive Subscale ( ADAS-cog ) ) .
METHODS	Secondary endpoints include assessments of activities of daily living and behavioral symptoms ( Clock Drawing Test ( CDT ) , Activities of Daily Living ( ADL ) and Instrumental Activities of Daily Living scale ( IADL ) ) .
CONCLUSIONS	This will be the first large-scale trial specifically evaluating acupuncture therapy in VCIND .
CONCLUSIONS	If the study confirms the effectiveness and safety of acupuncture treatment , it will be important to examine how the acupuncture approach could most effectively be integrated into the provision of routine healthcare .
BACKGROUND	This study is registered as an International Standard Randomised Controlled Trial on 17 January 2014 , number ISRCTN 82980206 .

###25436830
BACKGROUND	Death rates due to hypertension in low and middle income countries are higher compared to high income countries .
BACKGROUND	The present study is designed to combine life style modification and home blood pressure monitoring for control of hypertension in the context of low and middle income countries .
METHODS	The study is a two armed , parallel group , un-blinded , cluster randomized controlled trial undertaken within lower income areas in Kuala Lumpur .
METHODS	Two housing complexes will be assigned to the intervention group and the other two housing complexes will be allocated in the control group .
METHODS	Based on power analysis , 320 participants will be recruited .
METHODS	The participants in the intervention group ( n = 160 ) will undergo three main components in the intervention which are the peer support for home blood pressure monitoring , face to face health coaching on healthy diet and demonstration and training for indoor home based exercise activities while the control group will receive a pamphlet containing information on hypertension .
METHODS	The primary outcomes are systolic and diastolic blood pressure .
METHODS	Secondary outcome measures include practice of self-blood pressure monitoring , dietary intake , level of physical activity and physical fitness .
CONCLUSIONS	The present study will evaluate the effect of lifestyle modification and peer support home blood pressure monitoring on blood pressure control , during a 6 month intervention period .
CONCLUSIONS	Moreover , the study aims to assess whether these effects can be sustainable more than six months after the intervention has ended .

###24756512
OBJECTIVE	Time to thrombolysis is crucial for outcome in acute ischemic stroke .
OBJECTIVE	To determine if starting thrombolysis in a specialized ambulance reduces delays .
METHODS	In the Prehospital Acute Neurological Treatment and Optimization of Medical care in Stroke Study ( PHANTOM-S ) , conducted in Berlin , Germany , we randomly assigned weeks with and without availability of the Stroke Emergency Mobile ( STEMO ) from May 1 , 2011 , to January 31 , 2013 .
METHODS	Berlin has an established stroke care infrastructure with 14 stroke units .
METHODS	We included 6182 adult patients ( STEMO weeks : 44.3 % male , mean [ SD ] age , 73.9 [ 15.0 ] y ; control weeks : 45.2 % male , mean [ SD ] age , 74.3 [ 14.9 ] y ) for whom a stroke dispatch was activated .
METHODS	The intervention comprised an ambulance ( STEMO ) equipped with a CT scanner , point-of-care laboratory , and telemedicine connection ; a stroke identification algorithm at dispatcher level ; and a prehospital stroke team .
METHODS	Thrombolysis was started before transport to hospital if ischemic stroke was confirmed and contraindications excluded .
METHODS	Primary outcome was alarm-to-thrombolysis time .
METHODS	Secondary outcomes included thrombolysis rate , secondary intracerebral hemorrhage after thrombolysis , and 7-day mortality .
RESULTS	Time reduction was assessed in all patients with a stroke dispatch from the entire catchment area in STEMO weeks ( 3213 patients ) vs control weeks ( 2969 patients ) and in patients in whom STEMO was available and deployed ( 1804 patients ) vs control weeks ( 2969 patients ) .
RESULTS	Compared with thrombolysis during control weeks , there was a reduction of 15 minutes ( 95 % CI , 11-19 ) in alarm-to-treatment times in the catchment area during STEMO weeks ( 76.3 min ; 95 % CI , 73.2-79 .3 vs 61.4 min ; 95 % CI , 58.7-64 .0 ; P < .001 ) .
RESULTS	Among patients for whom STEMO was deployed , mean alarm-to-treatment time ( 51.8 min ; 95 % CI , 49.0-54 .6 ) was shorter by 25 minutes ( 95 % CI , 20-29 ; P < .001 ) than during control weeks .
RESULTS	Thrombolysis rates in ischemic stroke were 29 % ( 310/1070 ) during STEMO weeks and 33 % ( 200/614 ) after STEMO deployment vs 21 % ( 220/1041 ) during control weeks ( differences , 8 % ; 95 % CI , 4 % -12 % ; P < .001 , and 12 % , 95 % CI , 7 % -16 % ; P < .001 , respectively ) .
RESULTS	STEMO deployment incurred no increased risk for intracerebral hemorrhage ( STEMO deployment : 7/200 ; conventional care : 22/323 ; adjusted odds ratio [ OR ] , 0.42 , 95 % CI , 0.18-1 .03 ; P = .06 ) or 7-day mortality ( 9/199 vs 15/323 ; adjusted OR , 0.76 ; 95 % CI , 0.31-1 .82 ; P = .53 ) .
CONCLUSIONS	Compared with usual care , the use of ambulance-based thrombolysis resulted in decreased time to treatment without an increase in adverse events .
CONCLUSIONS	Further studies are needed to assess the effects on clinical outcomes .
BACKGROUND	clinicaltrials.gov Identifier : NCT01382862 .

###24779025
OBJECTIVE	To evaluate and compare the 3-year clinical performance of a silorane-based composite with that of a methacrylate-based composite in Class II restorations .
METHODS	Seventy-eight patients , each with two class II restorations under occlusion , were enrolled in this study .
METHODS	One hundred fifty-six restorations were placed , 50 % for each material : a silorane-based composite , Filtek P90 / P90 System Adhesive and a methacrylate-based resin composite , Quixfil / Prime & Bond NT .
METHODS	A single operator placed all restorations according to the manufacturers ' instructions .
METHODS	Immediately after placement , the restorations were finished/polished .
METHODS	Clinical evaluation was performed at baseline and at yearly intervals after placement by two other independent examiners using slightly modified USPHS criteria .
METHODS	The changes in the USPHS parameters during the three-year period were analyzed with the Friedman test .
METHODS	The baseline scores were compared with those at the recall visits using the Wilcoxon signed rank test .
METHODS	The level of significance was set at p < 0.05 .
RESULTS	All restorations were evaluated at 3 years .
RESULTS	Post-operative sensitivity was observed in 6 patients ( 2 Filtek P90 , 4 Quixfil ) between 1 and 3 weeks .
RESULTS	Seven failed restorations ( 4.5 % ) were observed during the follow up : 4 in the Filtek P90 ( 5.1 % ) and 3 in the Quixfil group ( 3.8 % ) .
RESULTS	This resulted in non-significantly different annual failure rates of 1.7 % and 1.2 % , respectively .
RESULTS	Fracture of restoration was the main reason for failure .
CONCLUSIONS	After 3 years , no significant difference was seen in overall clinical effectiveness between the silorane - based and methacrylate-based composite restorative systems .

###24740025
BACKGROUND	Prosthetic reconstruction of the breast , as a 2-staged procedure using tissue expanders followed by placement of permanent implants , offers favorable aesthetic results with minimal additional surgical intervention .
BACKGROUND	However , the current outpatient process to fill saline expanders can be lengthy and onerous , involving months of office visits and discomfort from the bolus saline expansions .
BACKGROUND	We present a new technology ( AeroForm Tissue Expansion System ) , which has the potential to improve the process of breast tissue expansion by providing a method for low-volume incremental filling , eliminating the need for injections and directly involving the patient by allowing her some control over the expansion process .
METHODS	The described study is a 2:1 randomized controlled trial of the investigational CO2 expansion system and saline expanders .
METHODS	Of the 82 women receiving expanders , 58 ( 39 bilateral and 19 unilateral ; bilateral rate , 67 % ) were implanted with CO2 tissue expanders and 24 subjects ( 15 bilateral and 9 unilateral ; bilateral rate , 63 % ) were implanted with saline expanders .
RESULTS	Preliminary validated expansion results were available for 55 women .
RESULTS	Available mean time for active expansion in the CO2 group was 18.2 ( 9.2 ) days ( median , 14.0 ; range , 5-39 ; number of expanders , 53 ) , which was less than the mean time for active expansion in the saline group : 57.4 ( 33.6 ) days ( median , 55 ; range , 5-137 ; number of expanders , 33 ) .
RESULTS	Available mean time from implant placement to exchange for a permanent prosthesis in the CO2 group was shorter [ 106.3 ( 42.9 ) days ; median , 99 ; range , 42-237 ; number of expanders , 53 ] than for the women in the control group [ 151.7 ( 62.6 ) days ; median , 140 ; range , 69-433 ; number of expanders , 33 ] .
RESULTS	After 2 events -- underexpansion ( n = 1 ) and erosion ( n = 1 ) -- in the CO2 group , the internal membrane was redesigned and the expander bulk was decreased to minimize the risk of underexpansion and erosion in subsequent patients .
CONCLUSIONS	Preliminary evidence indicates that the CO2-based tissue expansion system performs the same function as saline expansion devices without significantly altering the risk to the patient and that the device has the potential to make the expansion process faster and more convenient for both the patient and the physician .

###24885779
BACKGROUND	Cognitive bias modification ( CBM ) interventions have demonstrated efficacy in augmenting core biases implicated in psychopathology .
BACKGROUND	The current randomized controlled trial ( RCT ) will evaluate the efficacy of an internet-delivered positive imagery cognitive bias modification intervention for obsessive compulsive disorder ( OCD ) when compared to a control condition .
METHODS	Patients meeting diagnostic criteria for a current or lifetime diagnosis of OCD will be recruited via the research arm of a not-for-profit clinical and research unit in Australia .
METHODS	The minimum sample size for each group ( alpha set at 0.05 , power at .80 ) was identified as 29 , but increased to 35 to allow for 20 % attrition .
METHODS	We will measure the impact of CBM on interpretations bias using the OC Bias Measure ( The Ambiguous Scenarios Test for OCD ; AST-OCD ) and OC-beliefs ( The Obsessive Beliefs Questionnaire-TRIP ; OBQ-TRIP ) .
METHODS	Secondary outcome measures include the Dimensional Obsessive-Compulsive Scale ( DOCS ) , the Patient Health Questionnaire ( PHQ-9 ) , The Kessler Psychological Distress Scale ( K10 ) , and the Word Sentence Association Test for OCD ( WSAO ) .
METHODS	Change in diagnostic status will be indexed using the OCD Mini International Neuropsychiatric Interview ( M.I.N.I ) Module at baseline and follow-up .
METHODS	Intent-to-treat ( ITT ) marginal and mixed-effect models using restricted maximum likelihood ( REML ) estimation will be used to evaluate the primary hypotheses .
METHODS	Stability of bias change will be assessed at 1-month follow-up .
CONCLUSIONS	A limitation of the online nature of the study is the inability to include a behavioral outcome measure .
BACKGROUND	The trial was registered on 10 October 2013 with the Australian New Zealand Clinical Trials Registry ( ACTRN12613001130752 ) .

###25197908
BACKGROUND	Perennial allergic rhinitis ( PAR ) has a high and increasing prevalence worldwide .
BACKGROUND	Ear acupressure ( EAP ) is a noninvasive semi-self-administered form of acupuncture .
BACKGROUND	Previous studies indicated that EAP could be effective and safe for AR symptom management .
BACKGROUND	However , there was insufficient evidence to confirm this .
BACKGROUND	This study investigated whether EAP , a noninvasive clinical alternative to acupuncture , is effective and safe for PAR .
METHODS	This is an international , multicenter , randomized , single-blind , sham-controlled trial .
METHODS	The trial was conducted at two centers : Royal Melbourne Institute of Technology University ( Melbourne , Australia ) Clinical Trial Clinic and Guangdong Provincial Hospital of Chinese Medicine , Guangzhou , China .
METHODS	PAR participants were randomized to receive real or sham EAP treatment once a week for 8 weeks and then were followed-up for 12 weeks .
METHODS	Participants were instructed to administer EAP stimulation three times daily .
METHODS	Symptom severity and quality of life ( QoL ) were evaluated .
METHODS	Adverse events ( AEs ) were also monitored .
METHODS	Intention-to-treat analysis on change of symptom scores and QoL was applied .
RESULTS	Two hundred forty-five participants were randomly assigned to real ( n = 124 ) and sham EAP ( n = 121 ) groups .
RESULTS	Twenty-five participants discontinued during treatment and 15 participants dropped out during follow-up .
RESULTS	At the end of treatment and follow-up periods , changes of global QoL score were significantly greater in the real EAP group compared with the sham group .
RESULTS	At the end of follow-up , scores for total nasal symptom , runny nose , and eye symptoms in the real EAP group had a greater reduction compared with the sham group .
RESULTS	Overall , both real and sham EAP were well tolerated .
RESULTS	Two severe AEs were reported but were not considered related to the EAP procedures .
CONCLUSIONS	In conclusion , EAP showed short-term and extended benefit for improving PAR symptoms and QoL for PAR patients .

###24506815
BACKGROUND	Few studies to date have directly compared outcomes of retropubic ( RRP ) and laparoscopic ( LRP ) radical prostatectomy .
BACKGROUND	We investigated a single institution experience with RRP and LRP with respect to functional and pathological outcomes .
METHODS	168 patients who underwent RRP were compared to 171 patients who underwent LRP at our institution .
METHODS	Pathological and functional outcomes including postoperative urinary incontinence and erectile dysfunction ( ED ) of the two cohorts were examined .
RESULTS	Patients had bilateral , unilateral and no nerve sparing technique performed in 83.3 % , 1.8 % and 14.9 % of cases for RRP and 23.4 % , 22.8 % and 53.8 % of cases for LRP , respectively ( p < 0.001 ) .
RESULTS	Overall positive surgical margin rates were 22.2 % among patients who underwent RRP compared to 26.5 % of patients who underwent LRP ( p = 0.435 ) .
RESULTS	Based upon pads/day , urinary continence postoperatively was achieved in 83.2 % and 82.8 % for RRP and LRP , respectively ( p = 0.872 ) .
RESULTS	Analysis on postoperative ED was limited due to lack of information on the preoperative erectile status .
RESULTS	However , postoperatively there were no differences with respect to ED between the two cohorts ( p = 0.151 ) .
RESULTS	Based on ICIQ-scores , surgeons with more experience had lower rates of postoperative incontinence irrespective of surgical technique ( p = 0.001 and p < 0.001 for continuous and stratified data , respectively ) .
CONCLUSIONS	RRP and LRP represent effective surgical approaches for the treatment of clinically localized prostate cancer .
CONCLUSIONS	Pathological outcomes are excellent for both surgical techniques .
CONCLUSIONS	Functional outcomes including postoperative urinary incontinence and ED are comparable between the cohorts .
CONCLUSIONS	Surgeon experience is more relevant than surgical technique applied .

###25439711
BACKGROUND	Up to 87 % of professional musicians develop work-related complaints of the musculoskeletal system during their careers .
BACKGROUND	Music school students are at specific risk for developing musculoskeletal complaints and disabilities .
BACKGROUND	This study aims to evaluate the effectiveness of a biopsychosocial prevention program to prevent or reduce disabilities from playing-related musculoskeletal disorders .
BACKGROUND	Secondary objectives are evaluation of cost-effectiveness and feasibility .
METHODS	Healthy , first or second year students ( n = 150 ) will be asked to participate in a multicentre , single-blinded , parallel-group randomised controlled trial .
METHODS	Students randomised to the intervention group ( n = 75 ) will participate in a biopsychosocial prevention program that addresses playing-related health problems and provides postural training according to the Mensendieck or Cesar methods of postural exercise therapy , while incorporating aspects from behavioural change theories .
METHODS	A control group ( n = 75 ) will participate in a program that stimulates a healthy physical activity level using a pedometer , which conforms to international recommendations .
METHODS	No long-term effects are expected from this control intervention .
METHODS	Total follow-up duration is two years .
METHODS	The primary outcome measure is disability ( Disabilities of Arm , Shoulder and Hand questionnaire ) .
METHODS	The secondary outcome measures are pain , quality of life and changes in health behaviour .
METHODS	Multilevel mixed-effect logistic or linear regression analyses will be performed to analyse the effects of the program on the aforementioned outcome measurements .
METHODS	Furthermore , cost-effectiveness , cost-utility and feasibility will be analysed .
CONCLUSIONS	It is believed that this is the first comprehensive randomised controlled trial on the effect and rationale of a biopsychosocial prevention program for music students .

###24613333
OBJECTIVE	A post-approval ( PA ) study for destination therapy ( DT ) was required by the Food and Drug Administration ( FDA ) to determine whether results with the HeartMate ( HM ) II ( Thoratec , Pleasanton , California ) left ventricular assist device ( LVAD ) in a commercial setting were comparable to results during the DT multicenter pivotal clinical trial .
BACKGROUND	New device technology developed in the clinical research setting requires validation in a real-world setting .
METHODS	The PA study was a prospective evaluation of the first 247 HM II patients identified pre-operatively as eligible for DT in the national INTERMACS ( Interagency Registry for Mechanically Assisted Circulatory Support ) registry .
METHODS	Patients were enrolled from January to September 2010 at 61 U.S. centers and followed for 2 years .
METHODS	A historical comparison group included patients ( n = 133 at 34 centers ) enrolled in the primary data cohort in the DT pivotal trial ( TR ) .
METHODS	Survival rates and adverse events for the PA group were obtained from the INTERMACS registry .
RESULTS	Baseline characteristics were similar for PA versus TR .
RESULTS	Forty-five percent of PA patients were in INTERMACS profiles 1 to 2 and 28 % were in profile 3 .
RESULTS	Adverse events in the PA group were similar or lower than those in the TR group , including improvements in device-related infection ( 0.22 vs. 0.47 ) and post-operative bleeding requiring surgery ( 0.09 vs. 0.23 ) events per patient-year .
RESULTS	Kaplan-Meier survival at 2 years was 62 % ( PA group ) versus 58 % ( TR group ) .
RESULTS	PA group survival at 1 and 2 years was 82 5 % and 69 6 % for INTERMACS profiles 4 to 7 ( n = 63 ) versus 72 3 % and 60 4 % for profiles 1 to 3 ( n = 184 ) .
RESULTS	The median length of stay after surgery was reduced by 6 days in the PA group versus the TR group .
CONCLUSIONS	Results in a commercial patient care setting for the DT population supported the original pivotal clinical trial findings regarding the efficacy and risk profile of the HM II LVAD .
CONCLUSIONS	Survival was best in patients who were not inotrope-dependent ( INTERMACS profiles 4 to 7 ) .

###24691771
OBJECTIVE	To investigate how group-based exercise affects the levels of physical activity , physical fitness and health - related quality of life ( HRQoL ) in patients with chronic heart failure and comorbidities .
METHODS	Randomized controlled trial .
METHODS	A total of 48 patients ( 10 women , 38 men ) , mean age 71 years ( standard deviation 8 years ) , ejection fraction 27 % ( standard deviation 10 % ) , and New York Heart Association functional class II-III .
METHODS	A bicycle test , 6-min walk test ( 6MWT ) and muscle endurance tests were performed .
METHODS	Physical activity was assessed with a pedometer and the International Physical Activity Questionnaire ( IPAQ ) , HRQoL was evaluated with the Short Form-36 ( SF-36 ) .
METHODS	Patients were randomized to control or intervention groups .
METHODS	Intervention consisted of an individually designed group-based exercise programme twice a week , for a period of 3 months .
METHODS	Subjects in the control group were asked to continue with their usual lives .
RESULTS	A total of 42 patients completed the study , and 6 dropped-out .
RESULTS	Steps/day did not increase significantly after intervention ( p = 0.351 ) , but IPAQ score did ( p = 0.008 ) .
RESULTS	Exercise tolerance ( p = 0.001 ) , 6MWT ( p = 0.014 ) , shoulder abduction ( p = 0.028 ) , heel lift ( p < 0.0001 ) and HRQoL ( p = 0.018 ) improved significantly in the intervention group compared with the control group .
CONCLUSIONS	Group-based exercise did not improve the level of physical activity in patients with chronic heart failure and comorbidity ; however , physical fitness and HRQoL were significantly improved .

###24621858
BACKGROUND	Phase 1 evaluation of the VRC HIV DNA and rAd5 vaccines delivered intramuscularly ( i.m. ) supported proceeding to a Phase 2 b efficacy study .
BACKGROUND	Here we report comparison of the i.m. , subcutaneous ( s.c. ) and intradermal ( i.d. ) routes of administration .
METHODS	Sixty subjects were randomized to 6 schedules to evaluate the i.m. , s.c. or i.d. route for prime injections .
METHODS	Three schedules included DNA primes ( Wks 0,4,8 ) and 3 schedules included rAd5 prime ( Wk0 ) ; all included rAd5 i.m. boost ( Wk24 ) .
METHODS	DNA vaccine dosage was 4 mg i.m. or s.c. , but 0.4 mg i.d. , while all rAd5 vaccinations were 1010 PU .
METHODS	All injections were administered by needle and syringe .
RESULTS	Overall , 27/30 subjects completed 3 DNA primes ; 30/30 subjects completed rAd5 primes .
RESULTS	Mild local pruritus ( itchiness ) , superficial skin lesions and injection site nodules were associated with i.d. and s.c. , but not i.m. injections .
RESULTS	All routes induced T-cell and antibody immune responses after rAd5 boosting .
RESULTS	Overall , > 95 % had Env antibody and > 80 % had Env T-cell responses .
CONCLUSIONS	The pattern of local reactogenicity following i.d. and s.c. injections differed from i.m. injections but all routes were well-tolerated .
CONCLUSIONS	There was no evidence of an immunogenicity advantage following s.c. or i.d. delivery , supporting i.m. delivery as the preferred route of administration .
BACKGROUND	Clinicaltrials.gov NCT00321061 .

###25386945
BACKGROUND	Existing studies of mental health interventions in low-resource settings have employed highly structured interventions delivered by non-professionals that typically do not vary by client .
BACKGROUND	Given high comorbidity among mental health problems and implementation challenges with scaling up multiple structured evidence-based treatments ( EBTs ) , a transdiagnostic treatment could provide an additional option for approaching community-based treatment of mental health problems .
BACKGROUND	Our objective was to test such an approach specifically designed for flexible treatments of varying and comorbid disorders among trauma survivors in a low-resource setting .
RESULTS	We conducted a single-blinded , wait-list randomized controlled trial of a newly developed transdiagnostic psychotherapy , Common Elements Treatment Approach ( CETA ) , for low-resource settings , compared with wait-list control ( WLC ) .
RESULTS	CETA was delivered by lay workers to Burmese survivors of imprisonment , torture , and related traumas , with flexibility based on client presentation .
RESULTS	Eligible participants reported trauma exposure and met severity criteria for depression and/or posttraumatic stress ( PTS ) .
RESULTS	Participants were randomly assigned to CETA ( n = 182 ) or WLC ( n = 165 ) .
RESULTS	Outcomes were assessed by interviewers blinded to participant allocation using locally adapted standard measures of depression and PTS ( primary outcomes ) and functional impairment , anxiety symptoms , aggression , and alcohol use ( secondary outcomes ) .
RESULTS	Primary analysis was intent-to-treat ( n = 347 ) , including 73 participants lost to follow-up .
RESULTS	CETA participants experienced significantly greater reductions of baseline symptoms across all outcomes with the exception of alcohol use ( alcohol use analysis was confined to problem drinkers ) .
RESULTS	The difference in mean change from pre-intervention to post-intervention between intervention and control groups was -0.49 ( 95 % CI : -0.59 , -0.40 ) for depression , -0.43 ( 95 % CI : -0.51 , -0.35 ) for PTS , -0.42 ( 95 % CI : -0.58 , -0.27 ) for functional impairment , -0.48 ( 95 % CI : -0.61 , -0.34 ) for anxiety , -0.24 ( 95 % CI : -0.34 , -0.15 ) for aggression , and -0.03 ( 95 % CI : -0.44 , 0.50 ) for alcohol use .
RESULTS	This corresponds to a 77 % reduction in mean baseline depression score among CETA participants compared to a 40 % reduction among controls , with respective values for the other outcomes of 76 % and 41 % for anxiety , 75 % and 37 % for PTS , 67 % and 22 % for functional impairment , and 71 % and 32 % for aggression .
RESULTS	Effect sizes ( Cohen 's d ) were large for depression ( d = 1.16 ) and PTS ( d = 1.19 ) ; moderate for impaired function ( d = 0.63 ) , anxiety ( d = 0.79 ) , and aggression ( d = 0.58 ) ; and none for alcohol use .
RESULTS	There were no adverse events .
RESULTS	Limitations of the study include the lack of long-term follow-up , non-blinding of service providers and participants , and no placebo or active comparison intervention .
CONCLUSIONS	CETA provided by lay counselors was highly effective across disorders among trauma survivors compared to WLCs .
CONCLUSIONS	These results support the further development and testing of transdiagnostic approaches as possible treatment options alongside existing EBTs .
BACKGROUND	ClinicalTrials.gov NCT01459068 Please see later in the article for the Editors ' Summary .

###24344689
OBJECTIVE	The wide use of computed tomography ( CT ) for diverticulitis has initiated new classifications , but their reliability has not been studied .
OBJECTIVE	The aim of the study was to assess the inter-observer agreement of radiologists on the classifications of diverticulitis .
METHODS	A set of 100 CT examinations of patients with an episode of diverticulitis was used to assess inter-observer agreement .
METHODS	Cases were derived from two prospective trials and a retrospective cohort to comprise an evenly distributed case mix of patients .
METHODS	The reference standard was the modified Hinchey classification based on all available information .
METHODS	Three blinded radiologists independently read all CT examinations .
METHODS	We calculated the proportion of agreement and kappa values for the Hinchey and Ambrosetti classifications .
METHODS	For the Dharmarajan classification only inter-observer agreement was calculated .
RESULTS	The agreement with the reference standard was substantial for both the modified Hinchey and the Ambrosetti classifications ( P = 0.68 and P = 0.76 ) .
RESULTS	Overall inter-observer agreement for the modified Hinchey classification was substantial ( median kappa 0.72 ) , for the Ambrosetti classification almost perfect ( median kappa 0.83 ) and for the Dharmarajan classification substantial ( median kappa 0.76 ) .
CONCLUSIONS	The Ambrosetti classification is more reproducible than the modified Hinchey and Dharmarajan classifications .
CONCLUSIONS	The Ambrosetti and modified Hinchey classifications have a substantial agreement with the reference standard and therefore produce a reliable classification .
CONCLUSIONS	The Dhamarajan is applicable only in complicated diverticulitis and is an important complementary classification to the other more general classifications of diverticulitis .

###25005017
BACKGROUND	Exercise is beneficial to learning .
BACKGROUND	The purpose of this research was to determine whether an episode of aerobic exercise prior to practice improves the acquisition and retention of laparoscopic skills in the fundamentals of laparoscopic surgery ( FLS ) simulator .
METHODS	Baseline maximal physical fitness ( VO2 max ) , performance on peg transfer ( PT ) , pattern cut ( PC ) , and intracorporeal suture ( ICS ) were measured for FLS nave undergraduates .
METHODS	2 Weeks later , participants were randomized into exercise ( E ) and control ( C ) groups .
METHODS	C did unrelated work for 40 min and then practiced PT and PC for 10 min , and ICS for 15 min .
METHODS	Final scores were recorded .
METHODS	In E , participants ran on a treadmill for 20 min at 60 % of their VO2 max .
METHODS	After a 15 min cool down , they engaged in identical FLS simulator training as group C. Both groups completed the NASA task load index ( TLX ) to assess workload .
METHODS	Retention was recorded 2 months after the training session .
METHODS	Groups were compared using t tests , ( 2 ) and Wilcoxon rank tests .
METHODS	p < 0.05 was considered significant .
RESULTS	There were 52 participants ( 22 in C ; 30 in E ) with high physical fitness at baseline .
RESULTS	Demographics between the groups were similar at baseline .
RESULTS	There were no differences in VO2 max and scores on the three tasks at baseline ( all p values NS ) .
RESULTS	There was no statistical significance between the scores of the C and E groups at the training session and retention , except for higher PT scores in the E group after the training session .
CONCLUSIONS	In physically fit , surgically nave students , one bout of aerobic exercise enhanced immediate learning of simple FLS skills but did not have an impact on more complex skills or on retention .
CONCLUSIONS	The use of exercise in the surgical curriculum , or as a learning tool , warrants further investigation regarding how best to apply it .

###24615602
BACKGROUND	No studies have compared robot-assisted transaxillary thyroidectomy ( RATT ) and minimally invasive video-assisted thyroidectomy ( MIVAT ) regarding cosmetic outcome and satisfaction
METHODS	Patients matching the inclusion criteria ( benign nodule less than 4 cm and thyroid volume less than 30 mL ) were randomly allotted to undergo MIVAT ( group A ) or RATT ( group B ) .
METHODS	Cosmetic result , overall satisfaction , operative time , and complications were evaluated .
RESULTS	A total of 62 patients underwent hemithyroidectomy ( 30 in group A and 32 in group B ) .
RESULTS	All patients were women , with the exception of one man in each group .
RESULTS	The mean patient age was 36.9 years ( group A ) and 32.5 years ( group B ) .
RESULTS	Total operative time ( intubation-extubation ) was shorter in group A ( 71.6 min ) than in group B ( 120.4 min ) .
RESULTS	Complications included one transient laryngeal nerve injury in each group and one subcutaneous hematoma in group B. Postoperative hospital stay was longer in group B ( 1.85 days ) than in group A ( 1.15 days ) .
RESULTS	On the PASQ questionnaire , `` scar appearance '' and `` satisfaction with appearance '' scores were better in group A than in group B.
RESULTS	In the Short Form ( SF-36 ) 36-Item Health Survey Questionnaire , domains of `` social activity '' and `` general health '' were better in group B than in group A , whereas `` bodily pain '' scored higher in group B than in group A.
CONCLUSIONS	RATT seems not to supersede MIVAT in terms of satisfaction when comparing two groups of patients undergoing thyroidectomy for benign disease .

###25272582
BACKGROUND	Osteoporosis is a growing problem facing modern society and currently poses one of the most serious health challenges .
BACKGROUND	It is a progressive skeletal disease characterised by low bone mineral density whose development depends on multiple factors .
BACKGROUND	These principally include increasing age , nutrition , physical activity , endocrine changes , lifestyles , general health condition and taken drugs .
OBJECTIVE	To assess how much subjects ( aged > 50 years ) are aware of the dangers in contracting osteoporosis along with the effects that lifestyle and dairy product consumption can have on this condition developing .
METHODS	A questionnaire , designed in-house , was used to survey a group of 150 randomly selected individuals aged above 50 years .
METHODS	This was performed in June 2012 .
METHODS	Questions were on socio-demographics , milk and dairy product consumption , physical activity as well as assessing knowledge about osteoporosis that included issues such as its incidence , prevention and morbidity .
RESULTS	Osteoporosis was established in 60.7 % subjects of whom 69.2 % were women .
RESULTS	Only 9.3 % never consumed any dairy products .
RESULTS	Physical activity of some kind was undertaken by 77.3 % subjects .
RESULTS	Within the last year , 38.0 % reported having fractures of whom 46.0 % had osteoporosis and 25 % were healthy .
RESULTS	Respondents were aware that consuming dairy products is beneficial to bone health and this awareness was higher among those with osteoporosis .
RESULTS	Physical activity was also recognised to be important in preventing this condition .
CONCLUSIONS	Subjects suffering from osteoporosis had twice as many more fractures than healthy subjects .

###26280968
OBJECTIVE	Younger patients with unicompartmental degenerative knee joint diseases present a therapeutic dilemma .
OBJECTIVE	The purpose of this study is to evaluate the long-term results of the Oxford phase III unicompartmental knee replacement through a minimally invasive approach in the young patient .
METHODS	We have studied a total of 51 patients ( 59 interventions ) who underwent the Oxford Phase III Unicompartmental Knee Replacement .
METHODS	A clinical , radiographical and functional evaluation was performed twelve years after intervention .
RESULTS	According to the American Knee Society Score using Insall 's criteria overall results of unicompartmental knee arthroplasty showed an excellent or good outcome for 53 knees ( 96.36 % ) , fair for 1 ( 1.81 % ) and poor for 1 ( 1.81 % ) in the postoperative long term .
RESULTS	The survival rate of the implants was close to 95 % at follow-up .
CONCLUSIONS	Twelve years follow-up results of UKA through a minimally invasive exposure in young patients demonstrate predictably good outcomes .

###25305376
BACKGROUND	The HealthValues Healthy Eating Programme is a standalone Internet-based intervention that employs a novel strategy for promoting behavior change ( analyzing one 's reasons for endorsing health values ) alongside other psychological principles that have been shown to influence behavior .
BACKGROUND	The program consists of phases targeting motivation ( dietary feedback and advice , analyzing reasons for health values , thinking about health-related desires , and concerns ) , volition ( implementation intentions with mental contrasting ) , and maintenance ( reviewing tasks , weekly tips ) .
OBJECTIVE	The aim was to examine the effects of the program on consumption of fruit and vegetables , saturated fat , and added sugar over a 6-month period .
METHODS	A total of 82 females and 18 males were recruited using both online and print advertisements in the local community .
METHODS	They were allocated to an intervention or control group using a stratified block randomization protocol .
METHODS	The program was designed such that participants logged onto a website every week for 24 weeks and completed health-related measures .
METHODS	Those allocated to the intervention group also completed the intervention tasks at these sessions .
METHODS	Additionally , all participants attended laboratory sessions at baseline , 3 months , and 6 months .
METHODS	During these sessions , participants completed a food frequency questionnaire ( FFQ , the Block Fat/Sugar/Fruit / Vegetable Screener , adapted for the UK ) , and researchers ( blind to group allocation ) measured their body mass index ( BMI ) , waist-to-hip ratio ( WHR ) , and heart rate variability ( HRV ) .
RESULTS	Data were analyzed using a series of ANOVA models .
RESULTS	Per protocol analysis ( n = 92 ) showed a significant interaction for fruit and vegetable consumption ( P = .048 ) ; the intervention group increased their intake between baseline and 6 months ( 3.7 to 4.1 cups ) relative to the control group ( 3.6 to 3.4 cups ) .
RESULTS	Results also showed overall reductions in saturated fat intake ( 20.2 to 15.6 g , P < .001 ) and added sugar intake ( 44.6 to 33.9 g , P < .001 ) during this period , but there were no interactions with group .
RESULTS	Similarly , there were overall reductions in BMI ( 27.7 to 27.3 kg/m ( 2 ) , P = .001 ) and WHR ( 0.82 to 0.81 , P = .009 ) , but no interactions with group .
RESULTS	The intervention did not affect alcohol consumption , physical activity , smoking , or HRV .
RESULTS	Data collected during the online sessions suggested that the changes in fruit and vegetable consumption were driven by the motivational and maintenance phases of the program .
CONCLUSIONS	Results suggest that the program helped individuals to increase their consumption of fruit and vegetables and to sustain this over a 6-month period .
CONCLUSIONS	The observed reduction in fat and sugar intake suggests that monitoring behaviors over time is effective , although further research is needed to confirm this conclusion .
CONCLUSIONS	The Web-based nature of the program makes it a potentially cost-effective way of promoting healthy eating .

###24357420
BACKGROUND	Laparoscopic cholecystectomy ( LC ) is increasingly being performed as a day-care surgery .
BACKGROUND	Intraperitoneal ( IP ) instillation of lignocaine has been proved to provide pain relief following LC .
BACKGROUND	Of late , there is an increased interest in using intravenous ( IV ) lignocaine to provide pain relief following LC .
BACKGROUND	There are no studies in the existing literature as to which form of administration is more effective for pain relief .
BACKGROUND	Hence , this study has been undertaken .
METHODS	Patients ( n = 50 ) undergoing LC for symptomatic cholelithiasis were randomized into two groups ( n = 25 each ) to receive IV 2 % lignocaine from induction until 1 h after surgery or IP instillation of 0.2 % lignocaine in the gallbladder fossa after removal of gallbladder .
METHODS	Postoperative analgesic requirement , pain scores , time to return of bowel activity , and stress response were assessed .
RESULTS	The mean total morphine requirement ( p = 0.001 ) , median VAS , first analgesic requirement time ( p < 0.001 ) , and total PCA demands ( p < 0.001 ) during the 24-h period were statistically significantly less in the IV group compared with the IP group .
RESULTS	Return of bowel activity was earlier in the IV group , and it was statistically significant ( p < 0.001 ) .
RESULTS	However , stress response , respiratory function , and postoperative nausea and vomiting were not significant statistically among the two groups .
CONCLUSIONS	IV lignocaine is superior to IP lignocaine in providing pain relief following LC .
CONCLUSIONS	IV lignocaine has an added advantage of bringing about the early return of bowel activity , which will further facilitate surgeons to perform LC as a day-care procedure .

###26470422
OBJECTIVE	Evaluation of microbiological effectiveness of longidaze preparation use during therapy of active non-specific endometritis in women with uterus myoma .
METHODS	2 groups of women were formed by a method of random selection .
METHODS	The first was composed of patients with active chronic endometritis , that had received standard etiotropic antibacterial therapy .
METHODS	The second included patients , that had received longidaze in addition to the standard therapy .
METHODS	Therapy effectiveness evaluation was carried out based on the analysis of microbial landscape of cervical canal and uterine cavity 2 months after the therapy during phase I of the menstrual cycle .
RESULTS	Non-plasma-coagulating staphylococci , enterococci and anaerobes were established to be present predominately in the examined women of both the first and the second group .
CONCLUSIONS	The application of longidaze in combination with antibacterial therapy results in the most significant improvement of microbial landscape of cervical canal and uterine cavity .

###25452446
OBJECTIVE	Overexpression of COX-2 correlates with advanced stage and worse outcomes in non-small-cell lung cancer ( NSCLC ) , possibly as a result of elevated levels of COX-2-dependent prostaglandin E2 ( PGE2 ) .
OBJECTIVE	Exploratory analyses of studies that used COX-2 inhibitors have demonstrated potentially superior outcome in patients in whom the urinary metabolite of PGE2 ( PGE-M ) is suppressed .
OBJECTIVE	We hypothesized that patients with disease defined by PGE-M suppression would benefit from the addition of apricoxib to second-line docetaxel or pemetrexed .
METHODS	Patients with NSCLC who had disease progression after one line of platinum-based therapy , performance status of 0 to 2 , and normal organ function were potentially eligible .
METHODS	Only patients with a 50 % decrease in urinary PGE-M after 5 days of treatment with apricoxib could enroll .
METHODS	Docetaxel 75 mg/m ( 2 ) or pemetrexed 500 mg/m ( 2 ) once every 21 days per the investigator was administered with apricoxib or placebo 400 mg once per day .
METHODS	The primary end point was progression-free survival ( PFS ) .
METHODS	Exploratory analysis was performed regarding baseline urinary PGE-M and outcomes .
RESULTS	In all , 101 patients completed screening , and 72 of the 80 who demonstrated 50 % suppression were randomly assigned to apricoxib or placebo .
RESULTS	Toxicity was similar between the arms .
RESULTS	No improvement in PFS was seen with apricoxib versus placebo .
RESULTS	The median PFS for the control arm was 97 days ( 95 % CI , 52 to 193 days ) versus 85 days ( 95 % CI , 67 to 142 days ) for the experimental arm ( P = .91 ) .
CONCLUSIONS	Apricoxib did not improve PFS , despite biomarker-driven patient selection .

###25717250
OBJECTIVE	To determine the efficacy and safety benefits of performing intraoperative cholangiography ( IOC ) during laparoscopic cholecystectomy ( LC ) to treat symptomatic cholelithiasis .
METHODS	Patients admitted to the Minimally Invasive Surgery Center of Tianjin Nankai Hospital between January 2012 and January 2014 for management of symptomatic cholelithiasis were recruited for this prospective randomized trial .
METHODS	Study enrollment was offered to patients with clinical presentation of biliary colic symptoms , radiological findings suggestive of gallstones , and normal serum biochemistry results .
METHODS	Study participants were randomized to receive either routine LC treatment or LC+IOC treatment .
METHODS	The routine LC procedure was carried out using the standard four-port technique ; the LC+IOC procedure was carried out with the addition of meglumine diatrizoate ( 1:1 dilution with normal saline ) injection via a catheter introduced through a small incision in the cystic duct made by laparoscopic scissors .
METHODS	Operative data and postoperative outcomes , including operative time , retained common bile duct ( CBD ) stones , CBD injury , other complications and length of hospital stay , were recorded for comparative analysis .
METHODS	Inter-group differences were statistically assessed by the 2 test ( categorical variables ) and Fisher 's exact test ( binary variables ) , with the threshold for statistical significance set at P < 0.05 .
RESULTS	A total of 371 patients were enrolled in the trial ( late-adolescent to adult , age range : 16-70 years ) , with 185 assigned to the routine LC group and 186 to the LC+IOC group .
RESULTS	The two treatment groups were similar in age , sex , body mass index , duration of symptomology , number and size of gallstones , and clinical symptoms .
RESULTS	The two treatment groups also showed no significant differences in the rates of successful LC ( 98.38 % vs 97.85 % ) , CBD stone retainment ( 0.54 % vs 0.00 % ) , CBD injury ( 0.54 % vs 0.53 % ) and other complications ( 2.16 % vs 2.15 % ) , as well as in duration of hospital stay ( 5.101.41 d vs 4.991.53 d ) .
RESULTS	However , the LC+IOC treatment group showed significantly longer mean operative time ( routine LC group : 43.004.15 min vs 52.864.47 min , P < 0.01 ) .
RESULTS	There were no cases of fatal complications in either group .
RESULTS	At the one-year follow-up assessment , one patient in the routine LC group reported experiencing diarrhea for three months after the LC and one patient in the LC+IOC group reported on-going intermittent epigastric discomfort , but radiological examination provided no abnormal findings .
CONCLUSIONS	IOC addition to the routine LC treatment of symptomatic cholelithiasis does not improve rates of CBD stone retainment or bile duct injury but lengthens operative time .

###25092553
OBJECTIVE	The purpose of this study was to assess the effectiveness of global postural reeducation ( GPR ) relative to segmental exercises ( SE ) in the treatment of scapular dyskinesis ( SD ) associated with neck pain .
METHODS	Participants with SD and neck pain ( n = 30 ) aged 18 to 65 years were randomly assigned to one of two groups : GPR and SE ( stretching exercises ) .
METHODS	The upper extremity was assessed using the Disabilities of the Arm , Shoulder , and Hand questionnaire ; function of the neck was estimated using the Neck Disability Index ; pain severity was measured using a visual analogical scale ; and health-related quality of life was assessed using the Short Form-12 .
METHODS	Assessments were conducted at baseline and after 10 weekly sessions ( 60 minutes each ) .
METHODS	The significance level adopted was < .05 .
RESULTS	For pre-post treatment comparisons , GPR was significantly associated with improvements in function of neck and upper extremities , pain , and physical and mental domains of quality of life ( P < .05 ) .
RESULTS	Segmental exercises improved function of upper extremities and of the neck and severity of pain ( P < .05 ) .
RESULTS	When contrasting groups , GPR was significantly superior to SE in improving pain and physical domains of the quality of life .
CONCLUSIONS	This study showed that GPR and SE had similar effects on function of the neck and upper extremity in patients with SD associated with neck pain .
CONCLUSIONS	When comparing groups , GPR was superior to SE in improving pain and quality of life .

###25421272
BACKGROUND	It is widely believed that in patients with allergic rhinitis and asthma , avoidance of specific triggers can help improve symptom control and reduce need for medication .
BACKGROUND	Whilst most patients with asthma or rhinitis are sensitized to airborne allergens , primary care diagnostic and management decisions are often made without either obtaining a detailed history of the patient 's allergic triggers or performing skin prick tests .
BACKGROUND	Thus , management decisions are empirical and allergen avoidance advice is either not given or , if given , not tailored to the patient 's sensitivities .
METHODS	To ascertain whether allergy assessment and tailored advice in general practice for patients with asthma and rhinitis enhance well-being , we conducted a pragmatic , open , randomized controlled trial of allergy intervention ( structured allergy history and skin prick testing and appropriate advice on allergy avoidance ) versus usual care in adult patients with a working diagnosis of asthma and/or rhino-conjunctivitis .
METHODS	Outcomes were assessed after 12months by an observer who was blinded to allocation .
METHODS	The main outcome measures were asthma and rhinitis symptoms , disease-specific health-related quality of life , generic quality of life and lung function .
RESULTS	There were no significant differences in baseline demographics or disease characteristics between patients assigned to immediate or delayed skin prick testing .
RESULTS	No significant differences were observed between groups for any measures of symptoms , quality of life or lung function at 12months ( all P > 0.05 ) .
CONCLUSIONS	Amongst adults with known asthma and/or rhinitis in primary care , taking a structured allergy history with skin prick tests and giving tailored advice on allergy avoidance made no difference to their symptoms , quality of life or lung function as measured twelve months later .

###24960395
OBJECTIVE	The purpose of this study was to evaluate the clinical performance of posterior preveneered stainless steel crowns after three years .
METHODS	NuSmile crowns and Kinder Krowns were randomly allocated on paired molars using a split-mouth design .
METHODS	Variables such as fracture , wear , gingival health , and esthetics were recorded .
METHODS	( P < .05 ) .
RESULTS	Statistical analysis was completed on 34 paired crowns in 14 children .
RESULTS	After three years , 53 percent of crowns were fracture free compared to 81 percent at one year .
RESULTS	There was minimal esthetic impact for most fractures due to the location of the veneer fracture , but five crowns had extensive fracture .
RESULTS	No difference was reported in the clinical performance between the two crown types .
RESULTS	Fracture was more likely to occur where the adjacent tooth was missing .
RESULTS	Parents reported a satisfaction rating of 8.3 out of 10 .
CONCLUSIONS	Clinical performance of both crown types was similar and successful for three years .
CONCLUSIONS	Facing fracture occurred in 47 percent of crowns but had minimal impact on the esthetic value or parental satisfaction in the majority of cases .
CONCLUSIONS	These crowns offer an esthetic alternative to the traditional stainless steel crown , but parents should be alerted to the possibility of veneer loss over time .

###25035291
BACKGROUND	Treatment options for recurrent glioblastoma are scarce , with second-line chemotherapy showing only modest activity against the tumour .
BACKGROUND	Despite the absence of well controlled trials , bevacizumab is widely used in the treatment of recurrent glioblastoma .
BACKGROUND	Nonetheless , whether the high response rates reported after treatment with this drug translate into an overall survival benefit remains unclear .
BACKGROUND	We report the results of the first randomised controlled phase 2 trial of bevacizumab in recurrent glioblastoma .
METHODS	The BELOB trial was an open-label , three-group , multicentre phase 2 study undertaken in 14 hospitals in the Netherlands .
METHODS	Adult patients ( 18 years of age ) with a first recurrence of a glioblastoma after temozolomide chemoradiotherapy were randomly allocated by a web-based program to treatment with oral lomustine 110 mg/m ( 2 ) once every 6 weeks , intravenous bevacizumab 10 mg/kg once every 2 weeks , or combination treatment with lomustine 110 mg/m ( 2 ) every 6 weeks and bevacizumab 10 mg/kg every 2 weeks .
METHODS	Randomisation of patients was stratified with a minimisation procedure , in which the stratification factors were centre , Eastern Cooperative Oncology Group performance status , and age .
METHODS	The primary outcome was overall survival at 9 months , analysed by intention to treat .
METHODS	A safety analysis was planned after the first ten patients completed two cycles of 6 weeks in the combination treatment group .
METHODS	This trial is registered with the Nederlands Trial Register ( www.trialregister.nl , number NTR1929 ) .
RESULTS	Between Dec 11 , 2009 , and Nov 10 , 2011 , 153 patients were enrolled .
RESULTS	The preplanned safety analysis was done after eight patients had been treated , because of haematological adverse events ( three patients had grade 3 thrombocytopenia and two had grade 4 thrombocytopenia ) which reduced bevacizumab dose intensity ; the lomustine dose in the combination treatment group was thereafter reduced to 90 mg/m ( 2 ) .
RESULTS	Thus , in addition to the eight patients who were randomly assigned to receive bevacizumab plus lomustine 110 mg/m ( 2 ) , 51 patients were assigned to receive bevacizumab alone , 47 to receive lomustine alone , and 47 to receive bevacizumab plus lomustine 90 mg/m ( 2 ) .
RESULTS	Of these patients , 50 in the bevacizumab alone group , 46 in the lomustine alone group , and 44 in the bevacizumab and lomustine 90 mg/m ( 2 ) group were eligible for analyses .
RESULTS	9-month overall survival was 43 % ( 95 % CI 29-57 ) in the lomustine group , 38 % ( 25-51 ) in the bevacizumab group , 59 % ( 43-72 ) in the bevacizumab and lomustine 90 mg/m ( 2 ) group , 87 % ( 39-98 ) in the bevacizumab and lomustine 110 mg/m ( 2 ) group , and 63 % ( 49-75 ) for the combined bevacizumab and lomustine groups .
RESULTS	After the reduction in lomustine dose in the combination group , the combined treatment was well tolerated .
RESULTS	The most frequent grade 3 or worse toxicities were hypertension ( 13 [ 26 % ] of 50 patients in the bevacizumab group , three [ 7 % ] of 46 in the lomustine group , and 11 [ 25 % ] of 44 in the bevacizumab and lomustine 90 mg/m ( 2 ) group ) , fatigue ( two [ 4 % ] , four [ 9 % ] , and eight [ 18 % ] ) , and infections ( three [ 6 % ] , two [ 4 % ] , and five [ 11 % ] ) .
RESULTS	At the time of this analysis , 144/148 ( 97 % ) of patients had died and three ( 2 % ) were still on treatment .
CONCLUSIONS	The combination of bevacizumab and lomustine met prespecified criteria for assessment of this treatment in further phase 3 studies .
CONCLUSIONS	However , the results in the bevacizumab alone group do not justify further studies of this treatment .
BACKGROUND	Roche Nederland and KWF Kankerbestrijding .

###24226720
OBJECTIVE	A study designed to examine the importance of the sensory attributes of oral nutritional supplements on preference and likelihood of compliance .
METHODS	Independent individuals 50 years not currently receiving oral nutritional supplements were recruited to a two-stage , single-blind , randomised , preference study , conducted in four European countries .
METHODS	Stage 1 consisted of a 5-day trial period during which two units of commonly prescribed oral nutritional supplements were administered , with a different oral nutritional supplements being consumed each day .
METHODS	In Stage 2 , all participants consumed two units daily of one oral nutritional supplements for five days and two units daily of a second oral nutritional supplements for a further five days .
METHODS	Using standardised hedonic scales , participants reported their perceptions of each oral nutritional supplements for a range of sensory attributes , and estimated how many units of each oral nutritional supplements they could consume .
RESULTS	One thousand seven hundred seventy one individuals completed the study .
RESULTS	The overall opinion of each oral nutritional supplements was strongly correlated with taste ( r = 0.91 ; p < 0,0001 ) , while unit volume demonstrated a weak relationship ( r = 0,29 ; p < 0,0001 ) .
RESULTS	One oral nutritional supplements ( Reformulated Ensure Plus ) was preferred overall , scoring significantly higher for taste ( p < 0,05 ) and oral sensation ( p < 0,05 ) than other oral nutritional supplements .
CONCLUSIONS	This study contributes to the understanding of how sensory attributes , particularly taste and oral sensation , influence preference and compliance to oral nutritional supplements .

###24903987
OBJECTIVE	We are aimed to investigate whether right ventricular mid-septal pacing ( RVMSP ) is superior to conventional right ventricular apical pacing ( RVAP ) in improving clinical functional capacity and left ventricular ejection fraction ( LVEF ) for patients with high-degree atrio-ventricular block and moderately depressed left ventricle ( LV ) function .
METHODS	Ninety-two patients with high-degree atrio-ventricular block and moderately reduced LVEF ( ranging from 35 % to 50 % ) were randomly allocated to RVMSP ( n = 45 ) and RVAP ( n = 47 ) .
METHODS	New York Heart Association ( NYHA ) functional class , echocardiographic LVEF , and distance during a 6-min walk test ( 6MWT ) were determined at 18 months after pacemaker implantation .
METHODS	Serum levels of N-terminal pro-brain natriuretic peptide ( NT-proBNP ) were measured using an enzyme-linked immunosorbent assay ( ELISA ) kit .
RESULTS	Compared with baseline , NYHA functional class remained unchanged at 18 months , distance during 6MWT ( 485 m vs. 517 m ) and LVEF ( 36.7 % vs. 41.8 % ) were increased , but BNP levels were reduced ( 2352 pg/ml vs. 710 pg/ml ) in the RVMSP group compared with those in the RVAP group , especially in patients with LVEF 35 % -40 % ( for all comparisons , P < 0.05 ) .
RESULTS	However , clinical function capacity and LV function measurements were not significantly changed in patients with RVAP , despite the pacing measurements being similar in both groups , such as R-wave amplitude and capture threshold .
CONCLUSIONS	RVMSP provides a better clinical utility , compared with RVAP , in patients with high-degree atrioventricular block and moderately depressed LV function whose LVEF levels ranged from 35 % to 40 % .

###25786042
OBJECTIVE	To examine the effects of a supervised aerobic exercise programme on heart rate variability ( HRV ) parameters and symptom severity in women with fibromyalgia ( FM ) .
METHODS	Thirty-two women with FM were randomly allocated to one of two groups : aerobic exercise ( AE ) or usual care control for 24 weeks .
METHODS	Women allocated to AE performed two aerobic exercise sessions per week of 45-60 min duration including 15-20 min of steady-state aerobic exercise at 60-65 % of predicted maximum heart rate ( HRmax ) and 15 min of interval training at 75-80 % HRmax ( six repetitions of 1.5 min , with 1 min interpolated rest intervals ) .
METHODS	Cardiac autonomic modulation was assessed using power spectral analysis of HRV .
METHODS	Symptom severity was assessed by a 10 cm visual analogue scale ( VAS ) for pain , sleep disturbances , stiffness , anxiety and depression .
RESULTS	After 24 weeks , the women in the exercise group showed an increase ( 4.8 0.2 to 5.2 0.2 ) in total power ( LnTP , p < 0.001 ) , low frequency power ( LnLF , p < 0.01 ) , high frequency power ( LnHF , p < 0.001 ) , and the root-mean-square of successive R-R intervals ( rMSSD , p < 0.001 ) .
RESULTS	In addition , significant group-by-time interaction effects were observed for LnHF ( p = 0.036 ) and LnLF/HF ( p = 0.014 ) .
RESULTS	Improvements in anxiety and depression were also observed in AE versus control patients .
CONCLUSIONS	These results show that a programme of aerobic exercise training induced changes in cardiac autonomic nervous system modulation in FM and that these changes in HRV parameters were accompanied by changes in anxiety and depression .

###24528331
OBJECTIVE	This study investigated relevant pharmacodynamic and pharmacokinetic parameters during the transition from warfarin to rivaroxaban in healthy male subjects .
METHODS	Ninety-six healthy men were randomized into the following three groups : warfarin [ international normalized ratio ( INR ) 2.0-3 .0 ] transitioned to rivaroxaban 20mg once daily ( od ; group A ) ; warfarin ( INR 2.0-3 .0 ) followed by placebo od ( group B ) ; and rivaroxaban alone 20mg od ( group C ) for 4 days .
METHODS	Anti-factor Xa activity , inhibition of factor Xa activity , prothrombin time ( PT ) , activated partial thromboplastin time , HepTest , prothrombinase-induced clotting time , factor VIIa activity , factor IIa activity , endogenous thrombin potential and pharmacokinetics were measured .
RESULTS	An additive effect was observed on the PT and PT/INR during the initial transition period .
RESULTS	The mean maximal prolongation of PT was 4.39-fold [ coefficient of variation ( CV ) 18.03 % ; range 3.39-6 .50 ] of the baseline value in groupA , compared with 1.88-fold ( CV 10.35 % ; range 1.53-2 .21 ) in groupB and 1.57-fold ( CV 9.98 % ; range 1.37-2 .09 ) in groupC .
RESULTS	Rivaroxaban had minimal influence on the PT/INR at trough levels .
RESULTS	Inhibition of factor Xa activity , activated partial thromboplastin time and endogenous thrombin potential were also enhanced , but to a lesser extent .
RESULTS	In contrast , the effects of rivaroxaban on anti-factor Xa activity , HepTest and prothrombinase-induced clotting time were not affected by pretreatment with warfarin .
CONCLUSIONS	Changes in pharmacodynamics during the transition from warfarin to rivaroxaban vary depending on the test used .
CONCLUSIONS	A supra-additive effect on PT/INR is expected during the initial period of transition , but pretreatment with warfarin does not influence the effect of rivaroxaban on anti-factor Xa activity .

###24702797
BACKGROUND	Hope is an essential dimension of successful coping in the context of illnesses such as HIV/AIDS , because positive expectations for the future alleviate emotional distress , enhance quality of life and have been linked to the capacity for behavioural change .
BACKGROUND	The social environment ( e.g. family , peers ) is a regulator of hope for people living with HIV/AIDS ( PLWHA ) .
BACKGROUND	In this regard , the dual aim of this article is ( 1 ) to analyze the influence of a peer adherence support ( PAS ) intervention and the family environment on the state of hope in PLWHA and ( 2 ) to investigate the interrelationship between the two determinants .
METHODS	The Effective AIDS Treatment and Support in the Free State study is a prospective randomized controlled trial .
METHODS	Participants were recruited from 12 public antiretroviral treatment ( ART ) clinics across five districts in the Free State Province of South Africa .
METHODS	Each of these patients was assigned to one of the following groups : a control group receiving standard care , a group receiving additional biweekly PAS or a group receiving PAS and nutritional support .
METHODS	Latent cross-lagged modelling ( Mplus ) was used to analyse the impact of PAS and the family environment on the level of hope in PLWHA .
RESULTS	The results of the study indicate that neither PAS nor the family environment has a direct effect on the level of hope in PLWHA .
RESULTS	Subsequent analysis reveals a positive significant interaction between family functioning and PAS at the second follow-up , indicating that better family functioning increases the positive effect of PAS on the state of hope in PLWHA .
CONCLUSIONS	The interplay between well-functioning families and external PAS generates higher levels of hope , which is an essential dimension in the success of lifelong treatment .
CONCLUSIONS	This study provides additional insight into the important role played by family dynamics in HIV/AIDS care , and it underscores the need for PAS interventions that are sensitive to the contexts in which they are implemented .

###25255578
OBJECTIVE	To assess how acute consumption of fructose affects flow-mediated dilatation in brachial artery .
METHODS	The randomised cross-over study was conducted at the University of Nottingham 's Medical School , Nottingham , United Kingdom in July 2009 .
METHODS	Ten healthy , white European males visited the laboratory twice , on separate mornings .
METHODS	On each visit , the volunteers consumed water ( 3 ml/kg bodyweight ) and rested semi-supine on the bed .
METHODS	After 30 minutes , baseline diastolic brachial artery diameter and blood velocity was measured .
METHODS	At 60 minutes , blood velocity and five scans of brachial artery diameter were recorded before a blood pressure cuff was inflated on the forearm for 5 minutes and at 50-60-70-80 and 90 sec after cuff deflation .
METHODS	Fifteen minutes later , the volunteers consumed 500 ml of test-drink containing either fructose ( 0.75 g/kg bodyweight ) or sucralose ( sweetness-matched with fructose drink ) ; 45 minutes later , baseline and flow-mediated dilatation was re-measured .
RESULTS	Pre-drink and post-drink baseline values were similar on two occasions ( p > 0.05 ) .
RESULTS	Brachial artery diameter increased ( p < 0.05 ) by 7 + / - 3 % pre-fructose and by 6.9 + / - 3 % above baseline values post-fructose with no significant difference in these responses ( p < 0.15 ) .
RESULTS	It increased ( p < 0.05 ) by 5.9 + / - 3 % above baseline before and by 6.7 + / - 2 % ( p < 0.01 ) after sucralose ; a significant difference was noted in these flow-mediated dilatation responses ( p < 0.02 ) .
RESULTS	Responses before and after sucralose were not different from those before and after fructose ( p < 0.294 ) .
CONCLUSIONS	Acute ingestion of fructose or sucralose had no effect on flow-mediated dilatation measured at brachial artery .

###24332263
BACKGROUND	Sublingual immunotherapy with liquid extracts provides an appealing alternative to subcutaneous immunotherapy for the treatment of allergic rhinoconjunctivitis ( ARC ) , but a lack of robust evidence has deterred its use in North America .
OBJECTIVE	To determine the efficacy and tolerability of standardized glycerinated short ragweed sublingual allergen immunotherapy liquid ( RW-SAIL ) extract in subjects with ragweed-related ARC .
METHODS	This phase 3 , randomized , placebo-controlled trial was conducted in North America .
METHODS	Subjects ( age range , 18-55 years ) with or without asthma were selected based on ARC symptom severity and erythema skin prick reaction to short ragweed .
METHODS	Subjects self-administered the maximum tolerated dose of RW-SAIL ( n = 218 ) or placebo ( n = 211 ) daily beginning approximately 8 to 16 weeks before and through the end of the ragweed pollen season .
METHODS	The primary end point was subject-assessed total combined daily rhinoconjunctivitis symptom and medication scores ( TCS ) .
RESULTS	During the entire season , there was a 43 % decrease in TCS in subjects treated with RW-SAIL compared with placebo .
RESULTS	Similar decreases were observed in TCS between the 2 groups during peak season ( 42 % ) and in daily symptom scores during the entire ( 42 % ) and peak ( 41 % ) seasons .
RESULTS	The occurrence of adverse events was similar between the treatment groups ; most were mild in severity .
RESULTS	Treatment-related oromucosal local application site reactions occurred early and were transient and self-limited .
RESULTS	No anaphylaxis occurred .
CONCLUSIONS	This is the first successful North American confirmatory phase 3 clinical trial to demonstrate the safety and efficacy of a sublingual standardized ragweed allergen immunotherapy liquid extract for the treatment of ARC .

###25510692
OBJECTIVE	This study determined the correlation between the levels of reactive oxygen species ( ROS ) in prepared culture media and the early development of human embryos .
METHODS	This was an autocontrolled comparison study .
METHODS	A total of 159 patients undergoing invitro fertilization/intracytoplasmic sperm injection treatment were recruited in this study .
METHODS	The pH values , osmolarity pressures , and ROS levels of 15 batches of two culture media were measured .
METHODS	Sibling oocytes or embryos from individual patients were randomly assigned to two culture groups with Quinn 's Advantage Cleavage and Blastocyst media ( QAC/QAB ) or GIII series cleavage and blastocyst media ( G1 .3 / G2 .3 ) .
METHODS	The difference between the two culture groups was analyzed using one-sample t test .
RESULTS	The QAC/QAB and G1 .3 / G2 .3 media exhibited similar pH values and osmolarity pressures .
RESULTS	However , the prepared QAC/QAB media were characterized to contain lower amounts of ROS than the G1 .3 / G2 .3 media .
RESULTS	Furthermore , the blastocysts that developed under the QAC/QAB media were morphologically superior to those that developed under the G1 .3 / G2 .3 media .
CONCLUSIONS	The elevated ROS levels in culture media were associated with poor development of blastocyst-stage embryos .
CONCLUSIONS	Measurement of ROS levels may be a valuable process for medium selection or modification .

###26045340
BACKGROUND	Necitumumab is a second-generation , recombinant , human immunoglobulin G1 EGFR antibody .
BACKGROUND	In this study , we aimed to compare treatment with necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone in patients with previously untreated stage IV squamous non-small-cell lung cancer .
METHODS	We did this open-label , randomised phase 3 study at 184 investigative sites in 26 countries .
METHODS	Patients aged 18 years or older with histologically or cytologically confirmed stage IV squamous non-small-cell lung cancer , with an Eastern Cooperative Oncology Group ( ECOG ) performance status of 0-2 and adequate organ function and who had not received previous chemotherapy for their disease were eligible for inclusion .
METHODS	Enrolled patients were randomly assigned centrally 1:1 to a maximum of six 3-week cycles of gemcitabine and cisplastin chemotherapy with or without necitumumab according to a block randomisation scheme ( block size of four ) by a telephone-based interactive voice response system or interactive web response system .
METHODS	Chemotherapy was gemcitabine 1250 mg/m ( 2 ) administered intravenously over 30 min on days 1 and 8 of a 3-week cycle and cisplatin 75 mg/m ( 2 ) administered intravenously over 120 min on day 1 of a 3-week cycle .
METHODS	Necitumumab 800 mg , administered intravenously over a minimum of 50 min on days 1 and 8 , was continued after the end of chemotherapy until disease progression or intolerable toxic side-effects occurred .
METHODS	Randomisation was stratified by ECOG performance status and geographical region .
METHODS	Neither physicians nor patients were masked to group assignment because of the expected occurrence of acne-like rash -- a class effect of EGFR antibodies -- that would have unmasked most patients and investigators to treatment .
METHODS	The primary endpoint was overall survival , analysed by intention to treat .
METHODS	We report the final clinical analysis .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00981058 .
RESULTS	Between Jan 7 , 2010 , and Feb 22 , 2012 , we enrolled 1093 patients and randomly assigned them to receive necitumumab plus gemcitabine and cisplatin ( n = 545 ) or gemcitabine and cisplatin ( n = 548 ) .
RESULTS	Overall survival was significantly longer in the necitumumab plus gemcitabine and cisplatin group than in the gemcitabine and cisplatin alone group ( median 115 months [ 95 % CI 104-126 ] ) vs 99 months [ 89-111 ] ; stratified hazard ratio 084 [ 95 % CI 074-096 ; p = 001 ] ) .
RESULTS	In the necitumumab plus gemcitabine and cisplatin group , the number of patients with at least one grade 3 or worse adverse event was higher ( 388 [ 72 % ] of 538 patients ) than in the gemcitabine and cisplatin group ( 333 [ 62 % ] of 541 ) , as was the incidence of serious adverse events ( 257 [ 48 % ] of 538 patients vs 203 [ 38 % ] of 541 ) .
RESULTS	More patients in the necitumumab plus gemcitabine and cisplatin group had grade 3-4 hypomagnesaemia ( 47 [ 9 % ] of 538 patients in the necitumumab plus gemcitabine and cisplatin group vs six [ 1 % ] of 541 in the gemcitabine and cisplatin group ) and grade 3 rash ( 20 [ 4 % ] vs one [ < 1 % ] ) .
RESULTS	Including events related to disease progression , adverse events with an outcome of death were reported for 66 ( 12 % ) of 538 patients in the necitumumab plus gemcitabine and cisplatin group and 57 ( 11 % ) of 541 patients in the gemcitabine and cisplatin group ; these were deemed to be related to study drugs in 15 ( 3 % ) and ten ( 2 % ) patients , respectively .
RESULTS	Overall , we found that the safety profile of necitumumab plus gemcitabine and cisplatin was acceptable and in line with expectations .
CONCLUSIONS	Our findings show that the addition of necitumumab to gemcitabine and cisplatin chemotherapy improves overall survival in patients with advanced squamous non-small-cell lung cancer and represents a new first-line treatment option for this disease .
BACKGROUND	Eli Lilly and Company .

###24575717
OBJECTIVE	Motor imagery ( MI ) has been used as a complementary therapeutic tool for motor recovery after central nervous system disease and peripheral injuries .
OBJECTIVE	However , it has never been used as a preventive tool .
OBJECTIVE	We investigated the use of MI in the rehabilitation of stage II shoulder impingement syndrome .
OBJECTIVE	For the first time , MI is used before surgery .
METHODS	Sixteen participants were randomly assigned to either a MI or control group .
METHODS	Shoulder functional assessment ( Constant score ) , range of motion and pain were measured before and after intervention .
RESULTS	Higher Constant score was observed in the MI than in the control group ( p = 0.04 ) .
RESULTS	Participants in the MI group further displayed greater movement amplitude ( extension ( p < 0.001 ) ; flexion ( p = 0.025 ) ; lateral rotation ( p < 0.001 ) .
RESULTS	Finally , the MI group showed greater pain decrease ( p = 0.01 ) .
CONCLUSIONS	MI intervention seems to alleviate pain and enhance mobility , this is probably due to changes in muscle control and consequently in joint amplitude .
CONCLUSIONS	MI might contribute to postpone or even protect from passing to stage III that may require surgery .
CONCLUSIONS	Implications for Rehabilitation Adding motor imagery training to classical physical therapy in a stage II impingement syndrome : Helps in alleviating pain Enhances shoulder mobility Motor imagery is a valuable technique that can be used as a preventive tool before the stage III of the impingement syndrome .

###25164450
OBJECTIVE	Insulin sensitivity often decreases after surgery in spite of normal insulin secretion , and may worsen the outcome .
OBJECTIVE	This post-operative insulin resistance increases according to the magnitude of surgical invasion .
OBJECTIVE	However , supplementation of carbohydrates before surgery attenuates the post-operative insulin resistance .
OBJECTIVE	This study aimed to investigate the effect of intra-operative administration of low-dose glucose on the post-operative insulin resistance .
METHODS	Patients undergoing maxillofacial surgery were randomly assigned to two groups throughout the surgical procedure : The glucose group receiving acetated Ringer solution with 1.5 % glucose and the control group receiving acetated Ringer solution without glucose .
METHODS	Insulin resistance quantified by the mean glucose infusion rate ( the glucose infusion rate ) was evaluated by glucose clamp using the STG-22TM instrument on the previous day and on the next day of surgery .
METHODS	Blood glucose level was monitored continuously during surgery .
METHODS	In addition , serum insulin , ketone bodies and 3-methylhistidine were measured during perioperative period .
RESULTS	Patients in the glucose group ( n = 11 ) received 0.15 0.06 g/kg/h of glucose during surgery , while patients in the control group ( n = 11 ) received no glucose .
RESULTS	In both groups , however , the mean blood glucose levels were maintained stable at less than 150 mg/dL during and after surgery .
RESULTS	The serum ketone bodies significantly increased after surgery in the control group ( p = 0.0035 ) , while it decreased significantly in the glucose group ( p = 0.043 ) .
RESULTS	The reduction rate in the glucose infusion rate was significantly lower in the glucose group , 43.3 20.7 % , than that in the control group , 57.7 9.3 % ( p = 0.041 ) .
CONCLUSIONS	Intra-operative small-dose of glucose administration may suppress ketogenesis and attenuate the post-operative insulin resistance without causing hyperglycemia .

###25437716
OBJECTIVE	To evaluate the efficacy of transcervical intralesional vasopressin injection to submucous myoma in hysteroscopic myomectomy from 2011 to 2014 .
METHODS	This was a prospective , randomized , double-blind study in a single center .
METHODS	Forty premenopausal women with symptomatic submucous myoma requiring hysteroscopic myomectomy were randomized to transcervical intralesional vasopressin injection or placebo in a 4:4 ratio .
METHODS	The primary outcome was operative time .
METHODS	Secondary outcomes including fluid volumes , blood loss , and visual clarity were compared between the two groups .
RESULTS	The median duration for myomectomy was 19.9 minutes ( range 3.1-54 .2 minutes ) in the vasopressin group compared with 29.0 minutes ( range 8.0-60 .9 minutes ) in the placebo group , a nonsignificant difference ( P = .14 ) .
RESULTS	There were significant reductions in the median volume of fluid used ( 4,200 mL [ range 1,300-21 ,000 mL ] compared with 9,800 mL ( range 1,500-23 ,000 mL ; P = .004 ) and fluid intravasation ( 0 mL [ range 0-3 ,100 ] compared with 300 mL [ range -150 -3,150 mL ; P = .029 ) in the vasopressin group .
RESULTS	The median intraoperative blood loss was reduced ( 5 mL [ range 1-50 mL ] compared with 20 mL [ range 1-150 mL ; P = .002 ) .
RESULTS	The operative surgeon rated that 95 % of the vasopressin group had `` minimal '' bleeding compared with 36.8 % in the placebo group .
RESULTS	The surgical field ( visual analog scale [ VAS ] 9 [ range 2-10 ] compared with 6 [ range 2-10 ; P < .001 ] ; 0 = worst visual clarity , 10 = best visual clarity ) and the effluent fluid ( VAS 1 [ range 0-7 ] compared with 4 [ range 0-8 ; P < .001 ] ; 0 = clear , 10 = unclear ) were statistically significantly clearer in the vasopressin group .
CONCLUSIONS	Transcervical intralesional vasopressin injection in hysteroscopic myomectomy did not reduce operative time but did reduce volume of inflow fluid , fluid intravasation , intraoperative blood loss , and improving visual clarity .
BACKGROUND	Centre for Clinical Research and Biostatistics , http://www.cct.cuhk.edu.hk/Registry/publictriallist.aspx , CUHK_CCT00291 .

###25394818
BACKGROUND	Postoperative nausea and vomiting ( PONV ) are frequent but unwanted complications for patients following anaesthesia and cardiac surgery , affecting at least a third of patients , despite pharmacological treatment .
BACKGROUND	The primary aim of the proposed research is to test the efficacy of PC6 acupoint stimulation versus placebo for reducing PONV in cardiac surgery patients .
BACKGROUND	In conjunction with this we aim to develop an understanding of intervention fidelity and factors that support , or impede , the use of PC6 acupoint stimulation , a knowledge translation approach .
METHODS	712 postcardiac surgery participants will be recruited to take part in a two-group , parallel , superiority , randomised controlled trial .
METHODS	Participants will be randomised to receive a wrist band on each wrist providing acupressure to PC six using acupoint stimulation or a placebo .
METHODS	Randomisation will be computer generated , use randomly varied block sizes , and be concealed prior to the enrolment of each patient .
METHODS	The wristbands will remain in place for 36h .
METHODS	PONV will be evaluated by the assessment of both nausea and vomiting , use of rescue antiemetics , quality of recovery and cost .
METHODS	Patient satisfaction with PONV care will be measured and clinical staff interviewed about the clinical use , feasibility , acceptability and challenges of using acupressure wristbands for PONV .
BACKGROUND	Ethics approval will be sought from appropriate Human Research Ethics Committee/s before start of the study .
BACKGROUND	A systematic review of the use of wrist acupressure for PC6 acupoint stimulation reported minor side effects only .
BACKGROUND	Study progress will be reviewed by a Data Safety Monitoring Committee ( DSMC ) for nausea and vomiting outcomes at n = 350 .
BACKGROUND	Dissemination of results will include conference presentations at national and international scientific meetings and publications in peer-reviewed journals .
BACKGROUND	Study participants will receive a one-page lay-summary of results .
BACKGROUND	Australian New Zealand Clinical Trials Registry -- ACTRN12614000589684 .

###25635959
OBJECTIVE	To compare the effects of occlusal appliance therapy ( OA ) and therapist-guided relaxation training ( RT ) on temporomandibular disorder ( TMD ) pain in adolescents , thereby replicating a previous randomized controlled trial , and to explore whether additional therapy administered in a crossover sequential design improves treatment outcomes .
METHODS	The study involved 64 adolescents , aged 12 to 19 years , experiencing TMD pain at least once a week and diagnosed with myofascial pain in accordance with the Research Diagnostic Criteria for TMD .
METHODS	For phase 1 of the study , subjects were randomly assigned to OA or RT ; nonresponders were offered the other treatment in phase 2 .
METHODS	Self-reports of TMD pain and clinical assessments were performed before and after treatment in each phase and 6 months after the last treatment phase .
METHODS	Differences in outcomes between treatment groups across the different phases were analyzed by analysis of covariance ( ANCOVA ) , and for differences in proportions , the chi-square test was used .
RESULTS	After phase 1 , a significantly higher proportion of adolescents treated with OA ( 62.1 % ) than those treated with RT ( 17.9 % ) responded to treatment , defined as a subjective report of `` Completely well/Very much improved '' or `` Much improved . ''
RESULTS	Similar differences in self - report of treatment effect occurred after phase 2 .
RESULTS	About two-thirds of all adolescents in both phases reported such an improvement level at the 6-month follow-up , including a somewhat higher proportion of phase 1 responders ( 79.2 % ) than phase 1 nonresponders ( 60 % ) .
CONCLUSIONS	The findings suggest that , for adolescents with TMD pain , use of standardized clinical treatment with OA is more effective than RT on self-evaluation of treatment improvement .
CONCLUSIONS	For nonresponders , subsequent crossover treatment might be useful to improve subjective TMD pain .

###24365793
OBJECTIVE	The objective of this study is to determine the effect of intravenous ( i.v. ) or oral N-acetylcysteine ( NAC ) in preventing contrast-induced nephropathy ( CIN ) in patients with moderate-to-severe renal insufficiency undergoing intra-arterial interventions .
METHODS	We studied 307 patients with estimated glomerular filtration rate of less than 60 ml/min/1 .73 m undergoing an elective intra-arterial procedure .
METHODS	Patients were assigned randomly to three groups according to the prophylactic regimen used .
METHODS	In group 1 , patients were administered an i.v. infusion of 0.9 % saline ( n = 103 ) ; in group 2 , patients were administered oral NAC in addition to an i.v. saline infusion ( n = 102 ) ; and in group 3 , patients were administered i.v. NAC in addition to an i.v. saline infusion ( n = 102 ) .
METHODS	Serum creatinine ( SCr ) and cystatin C levels were measured at baseline and 4 , 24 , and 48 h after the application of contrast media .
METHODS	The primary endpoint was defined as an increase in the SCr or cystatin C concentration of at least 0.5 mg/dl and/or of at least 25 % from the baseline value at 48 h after administration of the contrast dye .
RESULTS	The overall incidence of SCr-based CIN was 11.1 % : 6.8 % in the saline group , 13.7 % in the oral NAC group , and 12.7 % in the i.v. NAC group ( P = 0.231 ) .
RESULTS	That of cystatin C-based CIN was 8.1 % : 6.8 % in the saline group , 6.9 % in the oral NAC group , and 10.8 % in the i.v. NAC group ( P = 0.491 ) .
CONCLUSIONS	In this study , there was no detectable benefit of either high-dose oral or i.v. NAC over an aggressive hydration protocol in patients with moderate-to-severe renal insufficiency .

###24485467
BACKGROUND	Neuromodulation techniques , i.e. repetitive transcranial magnetic stimulation ( rTMS ) and transcranial direct current stimulation ( tDCS ) , can modify cerebral hemodynamics .
BACKGROUND	High frequency rTMS appeared to decrease cerebral vasomotor reactivity ( VMR ) , while there is still poor evidence about the effect of low frequency ( LF ) rTMS on cerebral blood flow ( CBF ) and VMR .
OBJECTIVE	The present study aimed to test if LF rTMS decreases CBF and increases cerebral VMR .
OBJECTIVE	Monolateral or bilateral hemispheric involvement and duration of the effect were considered .
OBJECTIVE	A possible role of autonomic nervous system in CBF and VMR modulation was also investigated .
METHODS	Twenty-four right-handed healthy subjects underwent randomly real ( 12 ) or sham ( 12 ) 20-min 1-Hz rTMS on left primary motor cortex .
METHODS	Mean flow velocity and VMR of middle cerebral arteries were evaluated by means of transcranial Doppler before ( T0 ) , after 10 min ( T1 ) and after 2 ( T2 ) , 5 ( T3 ) and 24 h ( T4 ) from rTMS .
METHODS	Heart rate variability ( HRV ) was studied within the same timing interval , assessing low frequency/high frequency ( LF/HF ) ratio as index of autonomic balance .
RESULTS	After real rTMS compared with sham stimulation , MFV decreased bilaterally at T1 ( F = 3.240 , P = .030 ) while VMR increased bilaterally ( F = 5.116 , P = .002 ) for at least 5 h ( T3 ) .
RESULTS	LF/HF ratio decreased early after real rTMS ( F = 2.881 , P = .040 ) .
CONCLUSIONS	1-Hz rTMS may induce a bilateral long-lasting increase of VMR , while its effect on MFV is short-lasting .
CONCLUSIONS	Moreover , HRV changes induced by rTMS suggest a possible autonomic nervous system modulation .

###25093998
BACKGROUND	Heme oxygenase 1 ( HO-1 ) degrades heme and protects against oxidative stress .
BACKGROUND	In vitro and animal models suggest that HO-1 is beneficial in several diseases ( e.g. , postoperative ileus , gastroparesis , acute pancreatitis , and colitis ) .
BACKGROUND	However , the only drugs ( i.e. , hemin and heme arginate ) which pharmacologically upregulate HO-1 in humans are expensive and can only be administered intravenously .
BACKGROUND	Our aims were to compare the effects of placebo , aspirin , and simvastatin alone , and with - lipoic acid , on HO-1 protein concentration and activity in humans .
METHODS	This randomized , double-blind , placebo-controlled study compared the effects of three oral regimens administered for 7days , i.e. , placebo ; aspirin ( 325mg twice daily ) and simvastatin ( 40mg twice daily ) ; aspirin , simvastatin , and the sodium salt of R - - lipoic acid ( NaRLA , 600mg three times daily ) on markers of HO-1 activation ( i.e. , plasma HO-1 protein concentration and venous monocyte HO-1 protein activity ) in 18 healthy subjects ( 14 females ) .
METHODS	Markers of HO-1 activation were evaluated at baseline , days 2 , and 7 .
RESULTS	Baseline HO-1 protein concentrations and activity were similar among the three groups .
RESULTS	Compared to placebo , aspirin and simvastatin combined , or together with NaRLA did not affect HO-1 protein concentration or activity at 2 or 7days .
RESULTS	HO-1 protein concentrations and activity were correlated on day 7 ( r = 0.75 , p = 0.0004 ) but not at baseline and on day 2 .
CONCLUSIONS	At therapeutic doses , aspirin , simvastatin , and - lipoic acid do not increase plasma HO-1 protein concentration or venous monocyte HO-1 activity in healthy humans .

###24830400
OBJECTIVE	The effectiveness of the prophylactic clip for the prevention of postpolypectomy bleeding in pedunculated colonic polyps has not been confirmed .
OBJECTIVE	The aim of this prospective , randomized study was to compare the efficacy of prophylactic clip and endoloop application in the prevention of postpolypectomy bleeding in large pedunculated polyps .
METHODS	A total of 195 patients who had pedunculated colorectal polyps , with heads 10mm and stalks 5mm in diameter , were included in the study between July 2010 and January 2013 .
METHODS	Polyps were randomized to receive either clips or endoloops .
METHODS	Both devices were applied to the base of the stalk before conventional snare polypectomy .
METHODS	Bleeding complications were analyzed with a noninferiority margin of 5 % .
RESULTS	A total of 203 polyps were included in the study ( 98 in the clip group and 105 in the endoloop group ) .
RESULTS	Bleeding occurred after five polypectomies in the clip group ( 5.1 % ) and after six in the endoloop group ( 5.7 % ) ( P = 0.847 ) .
RESULTS	Noninferiority of the prophylactic clip to the endoloop could not be confirmed ( absolute bleeding rate difference-0 .6 % , 95 % confidence interval -5.6 % to 6.8 % ) due to small sample size .
RESULTS	Immediate bleeding episodes occurred in 4/5 polyps in the clip group and 5/6 polyps in the endoloop group .
RESULTS	Delayed bleeding occurred in one polyp in each group .
CONCLUSIONS	These results suggest that the application of a prophylactic clip is as effective and safe as an endoloop in the prevention of postpolypectomy bleeding in large pedunculated colonic polyps .
BACKGROUND	ClinicalTrials.gov ( NCT01406379 ) .

###25898052
OBJECTIVE	Exposing the oral mucosa to antigen may stimulate immune tolerance .
OBJECTIVE	It is unknown whether treatment with oral insulin can induce a tolerogenic immune response in children genetically susceptible to type 1 diabetes .
OBJECTIVE	To assess the immune responses and adverse events associated with orally administered insulin in autoantibody-negative , genetically at-risk children .
METHODS	The Pre-POINT study , a double-blind , placebo-controlled , dose-escalation , phase 1/2 clinical pilot study performed between 2009 and 2013 in Germany , Austria , the United States , and the United Kingdom and enrolling 25 islet autoantibody-negative children aged 2 to 7 years with a family history of type 1 diabetes and susceptible human leukocyte antigen class II genotypes .
METHODS	Follow-up was completed in August 2013 .
METHODS	Children were randomized to receive oral insulin ( n = 15 ) or placebo ( n = 10 ) once daily for 3 to 18 months .
METHODS	Nine children received insulin with dose escalations from 2.5 to 7.5 mg ( n = 3 ) , 2.5 to 22.5 mg ( n = 3 ) , or 7.5 to 67.5 mg ( n = 3 ) after 6 months ; 6 children only received doses of 22.5 mg ( n = 3 ) or 67.5 mg ( n = 3 ) .
METHODS	An immune response to insulin , measured as serum IgG and saliva IgA binding to insulin , and CD4 + T-cell proliferative responses to insulin .
RESULTS	Increases in IgG binding to insulin , saliva IgA binding to insulin , or CD4 + T-cell proliferative responses to insulin were observed in 2 of 10 ( 20 % [ 95 % CI , 0.1 % -45 % ] ) placebo-treated children and in 1 of 6 ( 16.7 % [ 95 % CI , 0.1 % -46 % ] ) children treated with 2.5 mg of insulin , 1 of 6 ( 16.7 % [ 95 % CI , 0.1 % -46 % ] ) treated with 7.5 mg , 2 of 6 ( 33.3 % [ 95 % CI , 0.1 % -71 % ] ) treated with 22.5 mg , and 5 of 6 ( 83.3 % [ 95 % CI , 53 % -99.9 % ] ) treated with 67.5 mg ( P = .02 ) .
RESULTS	Insulin-responsive T cells displayed regulatory T-cell features after oral insulin treatment .
RESULTS	No hypoglycemia , IgE responses to insulin , autoantibodies to glutamic acid decarboxylase or insulinoma-associated antigen 2 , or diabetes were observed .
RESULTS	Adverse events were reported in 12 insulin-treated children ( 67 events ) and 10 placebo-treated children ( 35 events ) .
CONCLUSIONS	In this pilot study of children at high risk for type 1 diabetes , daily oral administration of 67.5 mg of insulin , compared with placebo , resulted in an immune response without hypoglycemia .
CONCLUSIONS	These findings support the need for a phase 3 trial to determine whether oral insulin can prevent islet autoimmunity and diabetes in such children .
BACKGROUND	isrctn.org Identifier : ISRCTN76104595 .

###24417452
OBJECTIVE	The aim of this study was to evaluate complex intervention using time aids for children with intellectual and developmental disabilities who exhibit limitations in daily time management .
METHODS	Participating children ( n = 47 ) ( F17/M30 ) were aged 6-11 with ADHD , autism spectrum disorders , mild or moderate intellectual disability , spina bifida , and cerebral palsy .
METHODS	This study used a Randomized Block and Waiting List control group design , with 25 children allocated to control and 22 to intervention group .
METHODS	In total 10 children ( 21.3 % ) , five from each group , dropped out , leaving 37 children in the data analysis .
RESULTS	Children in both groups gained significantly in time-processing ability between the first and second data collection , but the children in the intervention group improved time-processing ability significantly more than controls .
RESULTS	The control group also displayed significant changes after receiving intervention between the second and third data collection .
RESULTS	The intervention had a large effect ( ES Cohen 's d = 0.81 ) on time-processing ability and a medium effect ( ES Cohen 's d = 0.68 ) on managing one 's time .
CONCLUSIONS	This study provides preliminary evidence that time-processing ability and managing one 's time can be improved by intervention using time aids in children with intellectual and developmental disabilities , supporting the need to consider time aids in intervention in these children .

###25077418
BACKGROUND	For regulatory approval , consistency in manufacturing of vaccine lots is expected to be demonstrated in confirmatory immunogenicity studies using two-sided equivalence trials .
BACKGROUND	This randomized , double-blind study ( NCT01323972 ) assessed consistency of three RTS , S/AS01 malaria vaccine batches formulated from commercial-scale purified antigen bulk lots in terms of anti-CS-responses induced .
METHODS	Healthy children aged 5-17 months were randomized ( 1:1:1:1 ) to receive RTS , S/AS01 at 0-1-2 months from one of three commercial-scale purified antigen bulk lots ( 1600 litres-fermentation scale ; commercial-scale lots ) , or a comparator vaccine batch made from pilot-scale purified antigen bulk lot ( 20 litres-fermentation scale ; pilot-scale lot ) .
METHODS	The co-primary objectives were to first demonstrate consistency of antibody responses against circumsporozoite ( CS ) protein at one month post-dose 3 for the three commercial-scale lots and second demonstrate non-inferiority of anti-CS antibody responses at one month post-dose 3 for the commercial-scale lots compared to the pilot-scale lot .
METHODS	Safety and reactogenicity were evaluated as secondary endpoints .
RESULTS	One month post-dose-3 , anti-CS antibody geometric mean titres ( GMT ) for the 3 commercial scale lots were 319.6 EU/ml ( 95 % confidence interval ( CI ) : 268.9-379 .8 ) , 241.4 EU/ml ( 207.6-280 .7 ) , and 302.3 EU/ml ( 259.4-352 .3 ) .
RESULTS	Consistency for the RTS , S/AS01 commercial-scale lots was demonstrated as the two-sided 95 % CI of the anti-CS antibody GMT ratio between each pair of lots was within the range of 0.5-2 .0 .
RESULTS	GMT of the pooled commercial-scale lots ( 285.8 EU/ml ( 260.7-313 .3 ) ) was non-inferior to the pilot-scale lot ( 271.7 EU/ml ( 228.5-323 .1 ) ) .
RESULTS	Each RTS , S/AS01 lot had an acceptable tolerability profile , with infrequent reports of grade 3 solicited symptoms .
RESULTS	No safety signals were identified and no serious adverse events were considered related to vaccination .
CONCLUSIONS	RTS , S/AS01 lots formulated from commercial-scale purified antigen bulk batches induced a consistent anti-CS antibody response , and the anti-CS GMT of pooled commercial-scale lots was non-inferior to that of a lot formulated from a pilot-scale antigen bulk batch .

###25636792
OBJECTIVE	In resource-poor settings , the standard of care to inform labour management is the partograph plus Pinard stethoscope for intermittent fetal heart rate ( FHR ) monitoring .
OBJECTIVE	We compared FHR monitoring in labour using a novel , robust wind-up handheld Doppler with the Pinard as a primary screening tool for abnormal FHR on perinatal outcomes .
METHODS	Prospective equally randomised clinical trial .
METHODS	The labour and delivery unit of a teaching hospital in Kampala , Uganda .
METHODS	Of the 2042 eligible antenatal women , 1971 women in active term labour , following uncomplicated pregnancies , were randomised to either the standard of care or not .
METHODS	Intermittent FHR monitoring using Doppler .
METHODS	Incidence of FHR abnormality detection , intrapartum stillbirth and neonatal mortality prior to discharge .
RESULTS	Age , parity , gestational age , mode of delivery and newborn weight were similar between study groups .
RESULTS	In the Doppler group , there was a significantly higher rate of FHR abnormalities detected ( incidence rate ratio ( IRR ) = 1.61 , 95 % CI 1.13 to 2.30 ) .
RESULTS	However , in this group , there were also higher though not statistically significant rates of intrapartum stillbirths ( IRR = 3.94 , 0.44 to 35.24 ) and neonatal deaths ( IRR = 1.38 , 0.44 to 4.34 ) .
CONCLUSIONS	Routine monitoring with a handheld Doppler increased the identification of FHR abnormalities in labour ; however , our trial did not find evidence that this leads to a decrease in the incidence of intrapartum stillbirth or neonatal death .
BACKGROUND	Clinical Trails.gov ( 1000031587 ) .

###24607365
OBJECTIVE	Determine if employment-based reinforcement can increase methadone treatment engagement and drug abstinence in out-of-treatment injection drug users .
METHODS	This study was conducted from 2008 to 2012 in a therapeutic workplace in Baltimore , MD. .
METHODS	After a 4-week induction , participants ( N = 98 ) could work and earn pay for 26 weeks and were randomly assigned to Work Reinforcement , Methadone & Work Reinforcement , and Abstinence , Methadone & Work Reinforcement conditions .
METHODS	Work Reinforcement participants had to work to earn pay .
METHODS	Methadone & Work Reinforcement and Abstinence , Methadone , & Work Reinforcement participants had to enroll in methadone treatment to work and maximize pay .
METHODS	Abstinence , Methadone , & Work Reinforcement participants had to provide opiate - and cocaine-negative urine samples to maximize pay .
RESULTS	Most participants ( 92 % ) enrolled in methadone treatment during induction .
RESULTS	Drug abstinence increased as a graded function of the addition of the methadone and abstinence contingencies .
RESULTS	Abstinence , Methadone & Work Reinforcement participants provided significantly more urine samples negative for opiates ( 75 % versus 54 % ) and cocaine ( 57 % versus 32 % ) than Work Reinforcement participants .
RESULTS	Methadone & Work Reinforcement participants provided significantly more cocaine-negative samples than Work Reinforcement participants ( 55 % versus 32 % ) .
CONCLUSIONS	The therapeutic workplace can promote drug abstinence in out-of-treatment injection drug users .
CONCLUSIONS	Clinical trial registration number : NCT01416584 .

###26017589
BACKGROUND	Mastectomy flap necrosis is a common complication of immediate breast reconstruction that impacts recovery time and reconstructive success .
BACKGROUND	Nitroglycerin ointment is a topical vasodilator that has been shown to improve skin flap survival in an animal model .
BACKGROUND	The objective of this study was to evaluate whether the application of nitroglycerin ointment to the breast skin after mastectomy and immediate reconstruction causes a decrease in the rate of mastectomy flap necrosis compared with placebo .
METHODS	This study was conducted as a randomized controlled trial and included patients aged 21 to 69 years undergoing mastectomy and immediate breast reconstruction at the University of British Columbia-affiliated hospitals ( Vancouver , British Columbia , Canada ) .
METHODS	Patients with a medical history that precluded the administration of nitroglycerin were excluded from the study .
METHODS	The target sample size was 400 patients .
METHODS	Nitroglycerin ointment ( 45 mg ) or a placebo was applied to the mastectomy skin at the time of surgical dressing .
RESULTS	The trial was stopped at the first interim analysis after 165 patients had been randomized ( 85 to the treatment group and 80 to the placebo group ) .
RESULTS	Mastectomy flap necrosis developed in 27 patients ( 33.8 percent ) receiving placebo and in 13 patients ( 15.3 percent ) receiving nitroglycerin ointment ; the between-group difference was 18.5 percent ( p = 0.006 ; 95 percent CI , 5.3 to 31.0 percent ) .
RESULTS	Postoperative complications were similar in both groups [ nitroglycerin , 22.4 percent ( 19 of 85 ) ; placebo , 28.8 percent ( 23 of 80 ) ] .
CONCLUSIONS	In patients undergoing mastectomy and immediate reconstruction , there was a marked reduction in mastectomy flap necrosis in patients who received nitroglycerin ointment .
CONCLUSIONS	Nitroglycerin ointment application is a simple , safe , and effective way to help prevent mastectomy flap necrosis .
METHODS	Therapeutic , I.

###25252423
OBJECTIVE	To evaluate maternal-newborn outcomes with immediate or expectantly managed preeclampsia first diagnosed at 34-37 weeks .
METHODS	Late preterm patients with preeclampsia without severe features were randomly assigned to immediate delivery ( n = 94 ) or expectant management ( n = 75 ) until 37 weeks gestation or earlier if severe features developed .
METHODS	Data were analyzed by appropriate tests for continuous or categorical outcomes with differences considered significant if p < 0.05 .
RESULTS	The two groups were similar at presentation .
RESULTS	41 % of those expectantly managed developed severe features of preeclampsia within 72 hours versus 3 % in the immediately delivered group ( p < 0.001 ) .
RESULTS	Immediate delivery did not significantly increase cesarean delivery or neonatal morbidity .
CONCLUSIONS	Immediate delivery of the late preterm patient with preeclampsia significantly lessens her development of severe features without significantly increasing newborn risks .
CONCLUSIONS	For the expectantly managed late preterm patient with preeclampsia , close surveillance for the first 72 hours following diagnosis and twice weekly thereafter appears prudent .

###25337966
OBJECTIVE	Reliable saphenous nerve blockade is a desirable complement to popliteal sciatic nerve blockade for foot and ankle surgery .
OBJECTIVE	We compared two promising ultrasound-guided techniques , the supine adductor canal ( AC ) technique and the prone peri-saphenous branch of the descending genicular artery ( Peri-SBDGA ) technique , using 8 mL of 2 % lidocaine with epinephrine 1:400,000 .
METHODS	Following Research Ethics Board approval , we conducted a randomized single-blinded parallel-group trial in 102 patients undergoing foot and ankle surgery at a single centre .
METHODS	The primary endpoint was saphenous nerve ease of visualization ( 0 = not visible ; 1 = visible with difficulty ; and 2 = easily visible ) .
METHODS	Other endpoints included vascular landmark visualization ( 0 = not visible ; 1 = visible with colour flow Doppler ; 2 = visible without colour flow Doppler ) , block success , onset , and complications .
RESULTS	Ninety-one patients were eligible for analysis .
RESULTS	Saphenous nerve visibility was not different between the groups ( visibility score = 2 : AC group , n = 24/49 [ 49 % ] vs Peri-SBDGA group , 20/42 [ 48 % ] ; P = 1.00 ) .
RESULTS	Vascular landmark visibility was better in the AC group than in the Peri-SBDGA group ( visibility score = 2 : 41/49 [ 84 % ] vs 25/42 [ 60 % ] , respectively ; P = 0.018 ) .
RESULTS	Block success rates were similar ( AC group , 41/49 [ 84 % ] vs Peri-SBDGA group , 34/42 [ 81 % ] ; P = 0.79 ) , as were median [ interquartile range ] onset times ( AC group , 5 [ 5-10 ] min vs Peri-SBDGA group , 8 [ 5-11 ] min ; P = 0.38 ) .
CONCLUSIONS	In this randomized trial , we found no differences in nerve visibility , block success rate , or onset between the AC and Peri-SBDGA techniques of ultrasound-guided saphenous nerve blockade , although the former technique provided superior vascular landmark visibility .
CONCLUSIONS	Neither technique produced a sufficiently high success rate to provide reliable surgical anesthesia per se .

###25400467
OBJECTIVE	To compare the effectiveness of needle-free incision suture closure with butterfly tape and traditional secondary suturing techniques in treating incision infection .
METHODS	Two hundred and twenty-three patients with incision infection following hepatobiliary surgery at a tertiary hospital were randomly divided into three groups : 90 patients were closed by needle-free incision suture closure , which gradually closed the incision wound when drainage from incision infection was visibly decreased and healthy granulation tissues had grown ; 79 patients were closed by butterfly bandage ; another 54 patients were closed by traditional secondary suturing technique .
METHODS	Healing time of incision infection was calculated from the beginning of dressing change to the healing of the incision .
RESULTS	Healing time in the needle-free incision suture closure group ( 24.2 7.2 d ) was significantly shorter than that in the butterfly bandage group ( 33.3 11.2 d ) and the traditional secondary suturing group ( 36.2 15.3 d ) ( P < 0.05 ) .
RESULTS	Healing time in the butterfly bandage group appeared to be slightly shorter than that in the secondary suture group , but the difference was not statistically significant ( P > 0.05 ) .
CONCLUSIONS	Needle-free incision suture closure could gradually close the infection wound at the same time of drainage and dressing change , thereby shortening the healing time .

###26441180
OBJECTIVE	Laparoscopic procedures are generally thought to have better outcomes than open procedures .
OBJECTIVE	Because of anatomical constraints , laparoscopic rectal resection may not be better because of limitations in performing an adequate cancer resection .
OBJECTIVE	To determine whether laparoscopic resection is noninferior to open rectal cancer resection for adequacy of cancer clearance .
METHODS	Randomized , noninferiority , phase 3 trial ( Australasian Laparoscopic Cancer of the Rectum ; ALaCaRT ) conducted between March 2010 and November 2014 .
METHODS	Twenty-six accredited surgeons from 24 sites in Australia and New Zealand randomized 475 patients with T1-T3 rectal adenocarcinoma less than 15 cm from the anal verge .
METHODS	Open laparotomy and rectal resection ( n = 237 ) or laparoscopic rectal resection ( n = 238 ) .
METHODS	The primary end point was a composite of oncological factors indicating an adequate surgical resection , with a noninferiority boundary of = -8 % .
METHODS	Successful resection was defined as meeting all the following criteria : ( 1 ) complete total mesorectal excision , ( 2 ) a clear circumferential margin ( 1 mm ) , and ( 3 ) a clear distal resection margin ( 1 mm ) .
METHODS	Pathologists used standardized reporting and were blinded to the method of surgery .
RESULTS	A successful resection was achieved in 194 patients ( 82 % ) in the laparoscopic surgery group and 208 patients ( 89 % ) in the open surgery group ( risk difference of -7.0 % [ 95 % CI , -12.4 % to ] ; P = .38 for noninferiority ) .
RESULTS	The circumferential resection margin was clear in 222 patients ( 93 % ) in the laparoscopic surgery group and in 228 patients ( 97 % ) in the open surgery group ( risk difference of -3.7 % [ 95 % CI , -7.6 % to 0.1 % ] ; P = .06 ) , the distal margin was clear in 236 patients ( 99 % ) in the laparoscopic surgery group and in 234 patients ( 99 % ) in the open surgery group ( risk difference of -0.4 % [ 95 % CI , -1.8 % to 1.0 % ] ; P = .67 ) , and total mesorectal excision was complete in 206 patients ( 87 % ) in the laparoscopic surgery group and 216 patients ( 92 % ) in the open surgery group ( risk difference of -5.4 % [ 95 % CI , -10.9 % to 0.2 % ] ; P = .06 ) .
RESULTS	The conversion rate from laparoscopic to open surgery was 9 % .
CONCLUSIONS	Among patients with T1-T3 rectal tumors , noninferiority of laparoscopic surgery compared with open surgery for successful resection was not established .
CONCLUSIONS	Although the overall quality of surgery was high , these findings do not provide sufficient evidence for the routine use of laparoscopic surgery .
CONCLUSIONS	Longer follow-up of recurrence and survival is currently being acquired .
BACKGROUND	anzctr.org Identifier : ACTRN12609000663257 .

###25547513
BACKGROUND	Financial abuse of elders is an under acknowledged problem and professionals ' judgements contribute to both the prevalence of abuse and the ability to prevent and intervene .
BACKGROUND	In the absence of a definitive `` gold standard '' for the judgement , it is desirable to try and bring novice professionals ' judgemental risk thresholds to the level of competent professionals as quickly and effectively as possible .
BACKGROUND	This study aimed to test if a training intervention was able to bring novices ' risk thresholds for financial abuse in line with expert opinion .
METHODS	A signal detection analysis , within a randomised controlled trial of an educational intervention , was undertaken to examine the effect on the ability of novices to efficiently detect financial abuse .
METHODS	Novices ( n = 154 ) and experts ( n = 33 ) judged `` certainty of risk '' across 43 scenarios ; whether a scenario constituted a case of financial abuse or not was a function of expert opinion .
METHODS	Novices ( n = 154 ) were randomised to receive either an on-line educational intervention to improve financial abuse detection ( n = 78 ) or a control group ( no on-line educational intervention , n = 76 ) .
METHODS	Both groups examined 28 scenarios of abuse ( 11 `` signal '' scenarios of risk and 17 `` noise '' scenarios of no risk ) .
METHODS	After the intervention group had received the on-line training , both groups then examined 15 further scenarios ( 5 `` signal '' and 10 `` noise '' scenarios ) .
RESULTS	Experts were more certain than the novices , pre ( Mean 70.61 vs. 58.04 ) and post intervention ( Mean 70.84 vs. 63.04 ) ; and more consistent .
RESULTS	The intervention group ( mean 64.64 ) were more certain of abuse post-intervention than the control group ( mean 61.41 , p = 0.02 ) .
RESULTS	Signal detection analysis of sensitivity ( A ) and bias ( C ) revealed that this was due to the intervention shifting the novices ' tendency towards saying `` at risk '' ( C post intervention -.34 ) and away from their pre intervention levels of bias ( C -.12 ) .
RESULTS	Receiver operating curves revealed more efficient judgments in the intervention group .
CONCLUSIONS	An educational intervention can improve judgements of financial abuse amongst novice professionals .

###24322192
BACKGROUND	Functional dyspepsia represents a frequent gastrointestinal disorder in clinical practice .
BACKGROUND	According to the Roma III criteria , functional dyspepsia can be classified into two types as the predominant symptom : epigastric pain and postprandial discomfort .
BACKGROUND	Even though the pathophysiology is still uncertain , the functional dyspepsia seems to be related to multiple mechanisms , among them visceral hypersensitivity , changes in the gastroduodenal motility and gastric accommodation and psychological factors .
OBJECTIVE	Evaluate the effectiveness of acupuncture as a complementary to conventional treatment in functional dyspepsia patients .
METHODS	Randomized clinical trial in which were enrolled patients with functional dyspepsia patients in according with Rome III criteria .
METHODS	One group was submitted to drug therapy and specific acupuncture ( GI ) and the other to drug therapy and non-specific acupuncture ( GII ) .
METHODS	The gastrointestinal symptoms , presence of psychiatric disorders and quality of life were evaluated , at the end and three months after treatment .
RESULTS	After 4 weeks of treatment there was improvement of gastrointestinal symptoms in Group I ( 55 12 vs 29 8.8 ; P = 0.001 ) and Group II ( 50.5 10.2 vs 46 10.5 ; P = 0.001 ) .
RESULTS	Quality of life was significantly better in Group I than group II ( 93.4 7.3 vs 102.4 5.1 ; P = 0.001 ) .
RESULTS	Anxiety ( 93.3 % vs 0 % ; P = 0.001 ) and depression ( 46.7 % vs 0 % ; P = 0.004 ) were significantly lower in Group I than group II .
RESULTS	When comparing the two groups after 4 weeks of treatment , gastrointestinal symptoms ( 29 8.8 vs 46 10.5 ; P < 0.001 ) and quality of life ( 102.4 5.1 vs 96 6.1 ; P = 0.021 ) were significantly better in Group I than group II .
RESULTS	Three months after the treatment , gastrointestinal symptoms remained better only in Group I , when compared to the pre-treatment values ( 38 11.3 vs 55 12 ; P = 0.001 ) .
CONCLUSIONS	In patients with functional dyspepsia the complementary acupuncture treatment is superior to conventional treatment .
CONCLUSIONS	Further studies with more patients are needed to confirm these findings .

###25641464
BACKGROUND	Less than 40 % of men with LUTS consult their doctor .
BACKGROUND	Patients consider the LUTS as physiological and are resigned to endure them .
BACKGROUND	It is necessary to foster awareness of the micturition disorders , to monitor their development and to assess the effectiveness of therapies .
BACKGROUND	At present the only validated test is the IPSS-Q8 , but in Italy it is used by only 4 % of General Practitioners ( GPs ) .
BACKGROUND	Because the IPSS is complex and not easy to handle , we need a more simple test but nevertheless efficient .
BACKGROUND	The Italian Society of Urology ( SIU ) and the Italian Society for Interdisciplinary Primary Care ( SIICP ) presented the `` Quick Prostate Test '' ( QPT ) in November 2012 .
BACKGROUND	We aimed to evaluate the efficiency of QPT versus the IPSSQ8 and its suitability in primary care .
METHODS	The QPT is composed of 3 questions to be answered `` yes '' or `` no . ''
METHODS	The answer `` yes '' just to one question makes `` positive '' the test .
METHODS	We enrolled 64 men , 50 years old , suffering from BPH , extracted from the database of five GPs .
METHODS	The patients were randomized into two arms : to the arm 1 only QPT was administered , to verify efficiency of the test ; to the arm 2 both the QPT that the IPSS-Q8 were administered .
RESULTS	Into the arm 1 , the 96.4 % has tested positive for QPT .
RESULTS	Into the arm 2 , the 89 % of patients with one or two positive responses to the QPT showed a moderate IPSSQ8 score ; the 75 % of the patients with three positive responses to the QPT had a serious IPSS-Q8 score .
RESULTS	The GPs ( 80 % ) have expressed the highest level of satisfaction for the QPT for the `` time of administration '' and for the `` simplicity '' of the test .
CONCLUSIONS	The experience with the QPT has shown that the test is efficient and suitable in the primary care setting .
CONCLUSIONS	We want to encourage the GPs to use the QPT for the monitoring of patients with lower urinary tract symptoms ( LUTS ) and to contribute to the validation of the test .

###24602844
BACKGROUND	Use of antiretroviral treatment for HIV-1 infection has decreased AIDS-related morbidity and mortality and prevents sexual transmission of HIV-1 .
BACKGROUND	However , the best time to initiate antiretroviral treatment to reduce progression of HIV-1 infection or non-AIDS clinical events is unknown .
BACKGROUND	We reported previously that early antiretroviral treatment reduced HIV-1 transmission by 96 % .
BACKGROUND	We aimed to compare the effects of early and delayed initiation of antiretroviral treatment on clinical outcomes .
METHODS	The HPTN 052 trial is a randomised controlled trial done at 13 sites in nine countries .
METHODS	We enrolled HIV-1-serodiscordant couples to the study and randomly allocated them to either early or delayed antiretroviral treatment by use of permuted block randomisation , stratified by site .
METHODS	Random assignment was unblinded .
METHODS	The HIV-1-infected member of every couple initiated antiretroviral treatment either on entry into the study ( early treatment group ) or after a decline in CD4 count or with onset of an AIDS-related illness ( delayed treatment group ) .
METHODS	Primary events were AIDS clinical events ( WHO stage 4 HIV-1 disease , tuberculosis , and severe bacterial infections ) and the following serious medical conditions unrelated to AIDS : serious cardiovascular or vascular disease , serious liver disease , end-stage renal disease , new-onset diabetes mellitus , and non-AIDS malignant disease .
METHODS	Analysis was by intention-to-treat .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00074581 .
RESULTS	1763 people with HIV-1 infection and a serodiscordant partner were enrolled in the study ; 886 were assigned early antiretroviral treatment and 877 to the delayed treatment group ( two individuals were excluded from this group after randomisation ) .
RESULTS	Median CD4 counts at randomisation were 442 ( IQR 373-522 ) cells per L in patients assigned to the early treatment group and 428 ( 357-522 ) cells per L in those allocated delayed antiretroviral treatment .
RESULTS	In the delayed group , antiretroviral treatment was initiated at a median CD4 count of 230 ( IQR 197-249 ) cells per L. Primary clinical events were reported in 57 individuals assigned to early treatment initiation versus 77 people allocated to delayed antiretroviral treatment ( hazard ratio 073 , 95 % CI 052-103 ; p = 0074 ) .
RESULTS	New-onset AIDS events were recorded in 40 participants assigned to early antiretroviral treatment versus 61 allocated delayed initiation ( 064 , 043-096 ; p = 0031 ) , tuberculosis developed in 17 versus 34 patients , respectively ( 049 , 028-089 , p = 0018 ) , and primary non-AIDS events were rare ( 12 in the early group vs nine with delayed treatment ) .
RESULTS	In total , 498 primary and secondary outcomes occurred in the early treatment group ( incidence 249 per 100 person-years , 95 % CI 225-275 ) versus 585 in the delayed treatment group ( 292 per 100 person-years , 265-321 ; p = 0025 ) .
RESULTS	26 people died , 11 who were allocated to early antiretroviral treatment and 15 who were assigned to the delayed treatment group .
CONCLUSIONS	Early initiation of antiretroviral treatment delayed the time to AIDS events and decreased the incidence of primary and secondary outcomes .
CONCLUSIONS	The clinical benefits recorded , combined with the striking reduction in HIV-1 transmission risk previously reported , provides strong support for earlier initiation of antiretroviral treatment .
BACKGROUND	US National Institute of Allergy and Infectious Diseases .

###24894026
OBJECTIVE	To test an intervention bundle for thirst intensity , thirst distress , and dry mouth , which are among the most pervasive , intense , distressful , unrecognized , and undertreated symptoms in ICU patients , but for which data-based interventions are lacking .
METHODS	This was a single-blinded randomized clinical trial in three ICUs in a tertiary medical center in urban California .
METHODS	A total of 252 cognitively intact patients reporting thirst intensity ( TI ) and/or thirst distress ( TD ) scores 3 on 0-10 numeric rating scales ( NRS ) were randomized to intervention or usual care groups .
METHODS	A research team nurse ( RTN # 1 ) obtained patients ' pre-procedure TI and TD scores and reports of dry mouth .
METHODS	She then administered a thirst bundle to the intervention group : oral swab wipes , sterile ice-cold water sprays , and a lip moisturizer , or observed patients in the usual care group .
METHODS	RTN # 2 , blinded to group assignment , obtained post-procedure TI and TD scores .
METHODS	Up to six sessions per patient were conducted across 2 days .
RESULTS	Multilevel linear regression determined that the average decreases in TI and TD scores from pre-procedure to post-procedure were significantly greater in the intervention group ( 2.3 and 1.8 NRS points , respectively ) versus the usual care group ( 0.6 and 0.4 points , respectively ) ( p < 0.05 ) .
RESULTS	The usual care group was 1.9 times more likely than the intervention group to report dry mouth for each additional session on day 1 .
CONCLUSIONS	This simple , inexpensive thirst bundle significantly decreased ICU patients ' thirst and dry mouth and can be considered a practice intervention for patients experiencing thirst .

###24375082
BACKGROUND	This study aimed to investigate the role of the effectiveness of camel milk ( CM ) ( raw and boiled ) on thymus and activation-regulated chemokine ( TARC ) serum levels and childhood autism rating scale ( CARS ) score in subjects with autism and compared to placebo group ( cow milk ) .
METHODS	Forty-five subjects diagnosed with autism were randomly assigned to receive boiled CM for group I ( n = 15 ) , raw CM for group II ( n = 15 ) , and placebo for group III ( n = 15 ) for 2 wk .
METHODS	Measures included changes in professionally completed CARS score and blood samples for TARC serum level were taken before and after milk consumption of 500ml per day in children 's regular daily diet .
RESULTS	The serum levels of TARC decreased significantly ( P = 0.004 ) in boiled CM and in raw CM group ( P = 0.01 ) too , but no effect was observed ( P = 0.68 ) in placebo group .
RESULTS	Furthermore , significant improvements were observed in CARS score ( P = 0.04 ) in raw CM group only .
RESULTS	There were no significant relationships between the serum of TARC level and the CARS score , age , or gender for any group .
CONCLUSIONS	CM administered for 2 wk significantly improved clinical measurements of autism severity and decreased serum level of TARC in autistic children , but subsequent studies are recommended .

###25356619
BACKGROUND	Single-photon emission computed tomography ( SPECT ) myocardial perfusion imaging is an accepted method for reflecting the pathophysiological significance of lesions detected by coronary angiography .
BACKGROUND	However , it has an inherent drawback in terms of false-positive perfusion defects for the inferior myocardial wall .
BACKGROUND	To overcome this problem , different acquisition techniques have been proposed , including the computed tomographic-based attenuation correction method .
BACKGROUND	In this respect , a new imaging technique , left supine lateral position SPECT myocardial perfusion imaging with technetium-99m methoxyisobutylisonitrile ( Tc-99m MIBI ) , has been proposed to eliminate this problem and its value has been investigated in this report .
METHODS	Sixty-two patients were prospectively and randomly enrolled in this study .
METHODS	They underwent Tc-99m MIBI SPECT in the supine , prone , left lateral , and sitting positions after an adequate stress test on the same day.The presence and extent of defects on stress images were noted in the supine image data set for the 11 myocardial segments , which were then labeled as 1 or 0 if a defect was present or absent , respectively .
METHODS	This evaluation sequence was repeated in all other image data sets .
METHODS	When defects persisted in other scan positions it was regarded as true positive , and when they were resolved they were regarded as false positive .
METHODS	By this means , the percentages of resolving perfusion defects by that imaging position were calculated for each observer per positional pair under comparison .
RESULTS	From six interpretations carried out by the nuclear medicine physicians , 6113 = 198 four-fold tables in 11 segments were analyzed for discrepancies between position pairs .
RESULTS	In 31 of 33 discrepant interpretations , defects observed in any of the other positions were resolved in the lateral position .
RESULTS	Only in two evaluations of one observer were the discrepancies against lateral positioning for the anterior wall .
RESULTS	If the inferior wall was considered alone , it was clearly obvious that lateral positioning was more accurate than the other positions.Intraobserver evaluation showed the methodology to be highly reproducible.The SPECT findings were concordant with coronary angiography results in selected patients .
CONCLUSIONS	Visual and quantitative evaluations of the variation in inferior wall activity lead us to suggest that SPECT imaging with Tc-99m MIBI be performed in the left lateral position to allow better visualization of the inferior and septal walls in those departments not able to utilize computed tomographic attenuation correction .

###24662296
OBJECTIVE	To compare the growth of HIV-exposed children receiving 1 of 2 complementary foods after prevention of mother-to-child HIV transmission through maternal lifelong antiretroviral therapy ( ART ) .
METHODS	In rural Malawi , 280 HIV-infected pregnant women were consecutively identified and offered ART , without consideration of their CD4 counts .
METHODS	Mothers were supported to exclusively breast-feed and children tested for HIV status at 1.5 and 5.5 months of age .
METHODS	From this group , 248 HIV-exposed children were enrolled and randomized to receive micronutrients with either whole milk powder or a ready-to-use complementary food ( RUF ) , until the child reached 12 months of age .
METHODS	Children were followed until 18 months of age .
RESULTS	HIV-free survival at 12 months was 90 % ( 95 % confidence interval : 87 % to 94 % ) .
RESULTS	Exclusive breast-feeding for the first 6 months of life was practiced in 97 % of the children .
RESULTS	At 12 months of age , 89 % of the children continued to be breast-fed .
RESULTS	At 6 months of age , infants had a weight-for-height z score of 0.7 1.1 ( mean SD ) and length-for-age z score of -1.3 1.2 .
RESULTS	The decrease in length-for-age z score among children receiving RUF at 12 months of age was greater than that seen in those receiving milk powder ( -0.3 0.8 vs -0.1 0.7 , P = 0.04 ) .
RESULTS	Mean weight-for-height z score was > 0 at 12 and 18 months of age in both groups .
CONCLUSIONS	HIV-free survival 90 % at 12 months was achieved with maternal ART while either milk powder or RUF as a complementary food preserved child anthropometry .
CONCLUSIONS	Breast-feeding by mothers receiving ART was acceptable .

###24368344
OBJECTIVE	Severe infections , often requiring ICU admission , have been associated with persistent cognitive dysfunction .
OBJECTIVE	Less severe infections are more common and whether they are associated with an increased risk of dementia is unclear .
OBJECTIVE	We determined the association of pneumonia hospitalization with risk of dementia in well-functioning older adults .
METHODS	Secondary analysis of a randomized multicenter trial to determine the effect of Gingko biloba on incident dementia .
METHODS	Five academic medical centers in the United States .
METHODS	Healthy community volunteers ( n = 3,069 ) with a median follow-up of 6.1 years .
METHODS	None .
RESULTS	We identified pneumonia hospitalizations using International Classification of Diseases , 9th Edition-Coding Manual codes and validated them in a subset .
RESULTS	Less than 3 % of pneumonia cases necessitated ICU admission , mechanical ventilation , or vasopressor support .
RESULTS	Dementia was adjudicated based on neuropsychological evaluation , neurological examination , and MRI .
RESULTS	Two hundred twenty-one participants ( 7.2 % ) incurred at least one hospitalization with pneumonia ( mean time to pneumonia = 3.5 yr ) .
RESULTS	Of these , dementia was developed in 38 ( 17 % ) after pneumonia , with half of these cases occurring 2 years after the pneumonia hospitalization .
RESULTS	Hospitalization with pneumonia was associated with increased risk of time to dementia diagnosis ( unadjusted hazard ratio = 2.3 ; CI , 1.6-3 .2 ; p < 0.0001 ) .
RESULTS	The association remained significant when adjusted for age , sex , race , study site , education , and baseline mini-mental status examination ( hazard ratio = 1.9 ; CI , 1.4-2 .8 ; p < 0.0001 ) .
RESULTS	Results were unchanged when additionally adjusted for smoking , hypertension , diabetes , heart disease , and preinfection functional status .
RESULTS	Results were similar using propensity analysis where participants with pneumonia were matched to those without pneumonia based on age , probability of developing pneumonia , and similar trajectories of cognitive and physical function prior to pneumonia ( adjusted prevalence rates , 91.7 vs 65 cases per 1,000 person-years ; adjusted prevalence rate ratio = 1.6 ; CI , 1.06-2 .7 ; p = 0.03 ) .
RESULTS	Sensitivity analyses showed that the higher risk also occurred among those hospitalized with other infections .
CONCLUSIONS	Hospitalization with pneumonia is associated with increased risk of dementia .

###25074318
BACKGROUND	Alpha glucosidase inhibitor ( GI ) attenuates postprandial hyperglycemia ( PPH ) and reduces the risk of cardiovascular events in patients with impaired glucose tolerance or type 2 diabetes .
BACKGROUND	Dipeptidyl peptidase 4 ( DPP-4 ) inhibitors also attenuate PPH .
BACKGROUND	PPH is one of the factors leading to endothelial dysfunction which is an early event in the pathogenesis of atherosclerosis .
BACKGROUND	Furthermore , DPP-4 inhibitors protect endothelial function through a GLP-1-dependent mechanism .
BACKGROUND	However , the impact of these two types of drugs on endothelial dysfunction in patients with type 2 diabetes has not been fully elucidated .
BACKGROUND	We compared the effects of sitagliptin , a DPP-4 inhibitor , and voglibose , an alpha GI , on endothelial function in patients with diabetes .
METHODS	We conducted a randomized prospective multicenter study in 66 patients with type 2 diabetes who did not achieve the treatment goal with sulfonylurea , metformin or pioglitazone treatment ; 31 patients received sitagliptin treatment and 35 patients , voglibose treatment .
METHODS	The flow-mediated dilatation ( FMD ) of the brachial artery was measured in the fasting state at baseline and after 12weeks of treatment .
METHODS	The primary endpoint was a change in FMD ( FMD ) from the baseline to the end of follow-up .
METHODS	The effects of sitagliptin and voglibose on FMD were assessed by ANCOVA after adjustment for the baseline FMD , age , sex , current smoking , diabetes duration and body mass index .
METHODS	Secondary efficacy measures included changes in HbA1c , GIP , GLP-1 , C-peptide , CD34 , lipid profile , oxidative stress markers , inflammatory markers and eGFR and any adverse events .
RESULTS	FMD was significantly improved after 12weeks of treatment in both groups , and there was no significant difference in FMD between the two groups .
RESULTS	There were no significant differences in changes in HbA1c , GIP , GLP-1 , C-peptide , lipid profile , oxidative stress marker , inflammatory marker and eGFR between the two groups .
RESULTS	Compared with voglibose , sitagliptin significantly increased the circulating CD34 , a marker of endothelial progenitor cells .
RESULTS	Adverse events were observed in 5 patients in only the voglibose group ( diarrhea 1 , nausea 1 , edema 2 and abdominal fullness 1 ) .
CONCLUSIONS	Sitagliptin improved endothelial dysfunction just as well as voglibose in patients with type 2 diabetes .
CONCLUSIONS	Sitagliptin had protective effects on endothelial function without adverse events .
BACKGROUND	registered at http://www.umin.ac.jp/ctrj/ under UMIN000003951 .

###24377635
BACKGROUND	Smoking among adolescents has been linked to a variety of adverse and long term health consequences .
BACKGROUND	`` Susceptibility to smoking '' or the lack of cognitive commitment to abstain from smoking is an important predictor of adolescent smoking .
BACKGROUND	In 2008 , we conducted a study to determine the psycho-sociological factors associated with susceptibility to smoking among secondary school students in the district of Kota Tinggi , Johor .
METHODS	Two thousand seven hundred students were randomly selected by proportional stratified sampling .
METHODS	Analyses on 1,736 non-smoking students revealed that prevalence of adolescents susceptible to smoking was 16.3 % .
RESULTS	Male gender ( aOR = 2.05 , 95 % CI = 1.23-3 .39 ) , poor academic achievement ( aOR 1.60 , 95 % CI 1.05-2 .44 ) , ever-smoker ( aOR 2.17 , 95 % CI 1.37-3 .44 ) and having a smoking friend ( aOR 1.76 , 95 % CI 1.10-2 .83 ) were associated with susceptibility to smoking , while having the perception that smoking prohibition in school was strictly enforced ( aOR 0.55 , 95 % CI 0.32-0 .94 ) , and had never seen friends smoking in a school compound ( aOR 0.59 , 95 % CI 0.37-0 .96 ) were considered protective factors
CONCLUSIONS	These results indicate that follow-up programmes need to capitalise on the modifiable factors related to susceptibility to smoking by getting all stakeholders to be actively involved to stamp out smoking initiation among adolescents .

###25265777
OBJECTIVE	To compare effectiveness of the generic form of gabapentin with its original form .
METHODS	A single-blind evaluation randomized controlled trial ( RCT ) of patients that were diagnosed with low back pain with suspected neuropathic component at the Department of Rehabilitation Medicine , King Chulalongkorn Memorial Hospital were included in the present study .
METHODS	Patients were randomized into two treatment groups .
METHODS	The first group received gabapentin generic form ( GGF ) or Gabapentin Sandoz , whereas the other received gabapentin original form ( GOF ) or Neurontin .
METHODS	The primary endpoint was the VisualAnalogue Scale ( VAS ) pain score .
METHODS	The secondary endpoints were the Thai version of the Oswestry low back pain disability index ( ODI ) score , lumbar spine 's range ofmotion , safety profiles , and average medical cost .
METHODS	Non-inferiority was pre-specified at 20 % .
METHODS	The amount of medication was increased to maintain VAS less than 40 mm and tapered off in case of adverse event .
RESULTS	Forty-one patients , GGF 21 and GOF 20 , had completed the study .
RESULTS	At 8th week , the visual analogue scale ( VAS ) and ODI scores significantly decreased in both groups .
RESULTS	Mean and standard deviation ( SD ) of VAS improvement were 31.4 + / - 22.1 mm for the GGF group versus 34.3 + / - 22.6 mm for the GOF group ( p = 0.69 ) , within pre-specified 20 % non-inferiority margin ( difference 2.9 mm 95 % CI-17 .7 mm , 11.8 mm ) .
RESULTS	Mean ODI improvement was 1.1 % for the GGF group versus 7.6 % for the GOF group ( p = 0.42 ) , within pre-specified 20 % non-inferiority margin , ( difference 3.5 , 95 % CI = -12.3 % , 5.3 % ) .
RESULTS	Both groups have significantly gainedflexion of the lumbar spine .
RESULTS	Both groups revealed similar safety profiles .
RESULTS	The GGF group showed significantly lower average cost for medications ( 2,844 baht ) .
CONCLUSIONS	In comparison with the GOF ( Neurontin ) group , the non-inferior effectiveness for pain reduction and improvement of back function has been revealed in the GGF ( Gabapentin Sandoz ) group .
CONCLUSIONS	Similar safety profiles were demonstrated in both groups .
CONCLUSIONS	The average medication cost of GGF is much lower than GOF ( 4.67 times ) .

###24297666
BACKGROUND	Important changes are occurring in how the medical profession approaches assessing and maintaining competence .
BACKGROUND	Physician support for such changes will be essential for their success .
OBJECTIVE	To describe physician attitudes towards assessing and maintaining competence .
METHODS	Cross-sectional internet survey .
METHODS	Random sample of 1,000 American College of Physicians members who were eligible to participate in the American Board of Internal Medicine Maintenance of Certification program .
METHODS	Questions assessed physicians ' attitudes and experiences regarding : 1 ) self-regulation , 2 ) feedback on knowledge and clinical care , 3 ) demonstrating knowledge and clinical competence , 4 ) frequency of use and effectiveness of methods to assess or improve clinical care , and 5 ) transparency .
RESULTS	Surveys were completed by 446 of 943 eligible respondents ( 47 % ) .
RESULTS	Eighty percent reported it was important ( somewhat/very ) to receive feedback on their knowledge , and 94 % considered it important ( somewhat/very ) to get feedback on their quality of care .
RESULTS	However , only 24 % reported that they receive useful feedback on their knowledge most/all of the time , and 27 % reported receiving useful feedback on their clinical care most/all of the time .
RESULTS	Seventy-five percent agreed that participating in programs to assess their knowledge is important to staying up-to-date , yet only 52 % reported participating in such programs within the last 3 years .
RESULTS	The majority ( 58 % ) believed physicians should be required to demonstrate their knowledge via a secure examination every 9-10 years .
RESULTS	Support was low for Specialty Certification Boards making information about physician competence publically available , with respondents expressing concern about patients misinterpreting information about their Board Certification activities .
CONCLUSIONS	A gap exists between physicians ' interest in feedback on their competence and existing programs ' ability to provide such feedback .
CONCLUSIONS	Educating physicians about the importance of regularly assessing their knowledge and quality of care , coupled with enhanced systems to provide such feedback , is needed to close this gap .

###24990296
BACKGROUND	The aim of this study is to compare the microleakage of Class II dental composite resin restorations which have been cured by three different LED ( light emitting diode ) light curing modes compared to control samples cured by QTH ( quartz tungsten halogen ) light curing units ( LCUs ) , to determine the most effective light curing unit and mode of curing .
RESULTS	In this experimental study , class II cavities were prepared on 100 sound human premolars which have been extracted for orthodontic treatment .
RESULTS	The teeth were randomly divided into four groups ; three experimental and one control group of 25 teeth each .
RESULTS	Experimental groups were cured by either conventional , pulse-delay , or ramped curing modes of LED .
RESULTS	The control group was cured for 20 seconds by QTH .
RESULTS	The restorations were thermocycled ( 1000 times , between 5 and 55C , for 5 seconds dwell time ) , dyed , sectioned mesio-distally and viewed under stereo-microscope ( 40 ) magnification .
RESULTS	Teeth were then scored on a 0 to 4 scale based on the amount of microleakage .
RESULTS	The data were analyzed by Chi-square test.No significant difference was demonstrated between the different LCUs ( light curing units ) , or modes of curing , at the enamel side ( p > 0.05 ) .
RESULTS	At the dentin side , all modes of LED curing could significantly reduce microleakage ( p < 0.05 ) .
RESULTS	The results suggest that slow start curing improves marginal integrity and seal .
RESULTS	High intense curing endangers those aims .
CONCLUSIONS	Comparison between the three LED mode cured composite resin restorations and QTH curing showed LED curing in all modes is more effective than QTH for reducing microleakage .
CONCLUSIONS	Both LED and QTH almost completely eliminate the microleakage on the enamel side , however none of them absolutely eliminated microleakage on the dentin side .

###25119120
OBJECTIVE	Determine whether absorbable or nonabsorbable mesh in repair of large hiatus hernias reduces the risk of recurrence , compared with suture repair .
BACKGROUND	Repair of large hiatus hernia is associated with radiological recurrence rates of up to 30 % , and to improve outcomes mesh repair has been recommended .
BACKGROUND	Previous trials have shown less short-term recurrence with mesh , but adverse outcomes limit mesh use .
METHODS	Multicentre prospective double blind randomized controlled trial of 3 methods of repair : sutures versus absorbable mesh versus nonabsorbable mesh .
METHODS	Primary outcome-hernia recurrence assessed by barium meal radiology and endoscopy at 6 months .
METHODS	Secondary outcomes-clinical symptom scores at 1 , 3 , 6 , and 12 months .
RESULTS	A total of 126 patients enrolled : 43 sutures , 41 absorbable mesh , and 42 nonabsorbable mesh .
RESULTS	Among them , 96.0 % were followed up to 12 months , with objective follow-up data in 92.9 % .
RESULTS	A recurrent hernia ( any size ) was identified in 23.1 % after suture repair , 30.8 % after absorbable mesh , and 12.8 % after nonabsorbable mesh ( P = 0.161 ) .
RESULTS	Clinical outcomes were similar , except less heartburn at 3 and 6 months and less bloating at 12 months with nonabsorbable mesh ; more heartburn at 3 months , odynophagia at 1 month , nausea at 3 and 12 months , wheezing at 6 months ; and inability to belch at 12 months after absorbable mesh .
RESULTS	The magnitudes of the clinical differences were small .
CONCLUSIONS	No significant differences were seen for recurrent hiatus hernia , and the clinical differences were unlikely to be clinically significant .
CONCLUSIONS	Overall outcomes after sutured repair were similar to mesh repair .

###24516621
OBJECTIVE	To examine the effects of Diet ( D ) and Exercise ( E ) interventions on cardiovascular fitness , waist circumference , blood lipids , glucose metabolism , inflammation markers , insulin-like growth factor 1 ( IGF-1 ) and blood pressure in overweight and obese lactating women .
METHODS	At 10-14 wk postpartum , 68 Swedish women with a self-reported pre-pregnancy BMI of 25-35 kg/m ( 2 ) were randomized to a 12-wk behavior modification treatment with D , E , both or control using a 22 factorial design .
METHODS	The goal of D treatment was to reduce body weight by 0.5 kg/wk , accomplished by decreasing energy intake by 500 kcal/d and monitoring weight loss through self-weighing .
METHODS	The goal of E treatment was to perform 4 45-min walks per wk at 60-70 % of max heart-rate using a heart-rate monitor .
METHODS	Effects were measured 12 wk and 1 y after randomization .
METHODS	General Linear Modeling was used to study main and interaction effects adjusted for baseline values of dependent variable .
RESULTS	There was a significant main effect of the D treatment , decreasing waist circumference ( P = 0.001 ) , total cholesterol ( P = 0.007 ) , LDL-cholesterol ( P = 0.003 ) and fasting insulin ( P = 0.042 ) , at the end of the 12-wk treatment .
RESULTS	The decreased waist circumference ( P < 0.001 ) and insulin ( P = 0.024 ) was sustained and HDL-cholesterol increased ( P = 0.005 ) at the 1-y follow-up .
RESULTS	No effects from the E treatment or any interaction effects were observed .
CONCLUSIONS	Dietary behavior modification that produced sustained weight loss among overweight and obese lactating women also improved risk factors for cardiovascular disease and type 2 diabetes .
CONCLUSIONS	This intervention may not only reduce weight-related risks with future pregnancies but also long-term risk for metabolic disease .
BACKGROUND	ClinicalTrials.gov NCT01343238 .

###25209897
BACKGROUND	There is as yet no evidence on the feasibility of implementing recommendations from the National Institute of Health and Care Excellence ( NICE ) osteoarthritis ( OA ) guidelines in primary care , or of the effect these recommendations have on the condition .
BACKGROUND	The primary aim of this study is to determine the clinical and cost effectiveness of a model OA consultation ( MOAC ) , implementing the core recommendations from the NICE OA guidelines in primary care .
BACKGROUND	Secondary aims are to investigate the impact , feasibility and acceptability of the MOAC intervention ; to develop and evaluate a training package for management of OA by general practitioners ( GPs ) and practice nurses ; test the feasibility of deriving ` quality markers ' of OA management using a new consultation template and medical record review ; and describe the uptake of core NICE OA recommendations in participants aged 45years and over with joint pain .
METHODS	A mixed methods study with a nested cluster randomised controlled trial .
METHODS	This study was developed according to a defined theoretical framework ( the Whole System Informing Self-management Engagement ) .
METHODS	An overarching model ( the Normalisation Process Theory ) will be employed to undertake a comprehensive ` whole-system ' evaluation of the processes and outcomes of implementing the MOAC intervention .
METHODS	The primary outcome is general physical health ( Short Form-12 Physical component score [ PCS ] ) ( Ware 1996 ) .
METHODS	The impact , acceptability and feasibility of the MOAC intervention at practice level will be assessed by comparing intervention and control practices using a Quality Indicators template and medical record review .
METHODS	Impact and acceptability of the intervention for patients will be assessed via self-completed outcome measures and semi-structured interviews .
METHODS	The impact , acceptability and feasibility of the MOAC intervention and training for GPs and practice nurses will be evaluated using a variety of methods including questionnaires , semi-structured interviews , and observations .
CONCLUSIONS	The main output from the study will be to determine whether the MOAC intervention is clinically and cost effective .
CONCLUSIONS	Additional outputs will be the development of the MOAC for patients consulting with joint pain in primary care , training and educational materials , and resources for patients and professionals regarding supported self-management and uptake of NICE guidance .
BACKGROUND	ISRCTN number : ISRCTN06984617 .

###24294687
OBJECTIVE	Postoperative debridement is a controversial subject in the rhinology literature .
OBJECTIVE	The objective of this randomized controlled trial was to determine the effect of regular debridement versus no debridement on disease-specific outcomes and patient inconvenience .
METHODS	Patients with chronic rhinosinusitis with polyposis who were to undergo basic sinus surgery ( antrostomy , ethmoidectomy , and polypectomy ) were randomized to either debridement ( at postoperative weeks 2 and 4 ) or no debridement , and their outcomes were assessed at 4 weeks and at 6 months with the Lund-Kennedy Endoscopic Score ( LKES ) , the Sino-Nasal Outcome Test-21 ( SNOT-21 ) , a visual analog scale for postoperative pain , and a novel scoring system for postoperative inconvenience ( Post-Operative Inconvenience Scale ; POIS ) .
METHODS	All patients were instructed to use high-volume saline rinses twice daily .
RESULTS	At 4 weeks after operation , there was no difference between the groups in regard to LKESs ( control group , 2.1 of 20 ; debridement group , 2.4 of 20 ; p = 0.59 ) or SNOT scores ( control group , 9.1 ; debridement group , 8.3 ; p = 0.47 ) .
RESULTS	The visual analog scale pain scores showed significance ( control group , 19 mm ; debridement group , 38 mm ; p = 0.019 ) , as did the POIS scores ( control group , 18.3 ; debridement group , 6.1 ; p = 0.002 ) .
RESULTS	At 6 months after surgery , again no difference was seen between the groups on either LKESs or SNOT scores .
CONCLUSIONS	In our patient population , debridement after surgery did not affect disease-specific outcomes .

###24221838
BACKGROUND	Cardiovascular diseases are rising as a cause of death and disability in China .
BACKGROUND	To improve outcomes for patients with these conditions , the Chinese government , academic researchers , clinicians , and > 200 hospitals have created China Patient-Centered Evaluative Assessment of Cardiac Events ( China PEACE ) , a national network for research and performance improvement .
BACKGROUND	The first study from China PEACE , the Retrospective Study of Acute Myocardial Infarction ( China PEACE-Retrospective AMI Study ) , is designed to promote improvements in acute myocardial infarction ( AMI ) quality of care by generating knowledge about the characteristics , treatments , and outcomes of patients hospitalized with AMI across a representative sample of Chinese hospitals during the past decade .
RESULTS	The China PEACE-Retrospective AMI Study will examine > 18 000 patient records from 162 hospitals identified using a 2-stage cluster sampling design within economic-geographic regions .
RESULTS	Records were chosen from 2001 , 2006 , and 2011 to identify temporal trends .
RESULTS	Data quality will be monitored by a central coordinating center and will , in particular , address case ascertainment , data abstraction , and data management .
RESULTS	Analyses will examine patient characteristics , diagnostic testing patterns , in-hospital treatments , in-hospital outcomes , and variation in results by time and site of care .
RESULTS	In addition to publications , data will be shared with participating hospitals and the Chinese government to develop strategies to promote quality improvement .
CONCLUSIONS	The China PEACE-Retrospective AMI Study is the first to leverage the China PEACE platform to better understand AMI across representative sites of care and during the past decade in China .
CONCLUSIONS	The China PEACE collaboration among government , academicians , clinicians , and hospitals is poised to translate research about trends and patterns of AMI practices and outcomes into improved care for patients .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01624883 .

###25650040
BACKGROUND	Whereas thermal ablation of incompetent saphenous veins is highly effective , all heat-based ablation techniques require the use of perivenous subfascial tumescent anesthesia , involving multiple needle punctures along the course of the target vein .
BACKGROUND	Preliminary evidence suggests that cyanoacrylate embolization ( CAE ) may be effective in the treatment of incompetent great saphenous veins ( GSVs ) .
BACKGROUND	We report herein early results of a randomized trial of CAE vs radiofrequency ablation ( RFA ) for the treatment of symptomatic incompetent GSVs .
METHODS	Two hundred twenty-two subjects with symptomatic GSV incompetence were randomly assigned to receive either CAE ( n = 108 ) with the VenaSeal Sapheon Closure System ( Sapheon , Inc , Morrisville , NC ) or RFA ( n = 114 ) with the ClosureFast system ( Covidien , Mansfield , Mass ) .
METHODS	After discharge , subjects returned to the clinic on day 3 and again at months 1 and 3 .
METHODS	The study 's primary end point was closure of the target vein at month 3 as assessed by duplex ultrasound and adjudicated by an independent vascular ultrasound core laboratory .
METHODS	Statistical testing focused on showing noninferiority with a 10 % delta conditionally followed by superiority testing .
METHODS	No adjunctive procedures were allowed until after the month 3 visit , and missing month 3 data were imputed by various methods .
METHODS	Secondary end points included patient-reported pain during vein treatment and extent of ecchymosis at day 3 .
METHODS	Additional assessments included general and disease-specific quality of life surveys and adverse event rates .
RESULTS	All subjects received the assigned intervention .
RESULTS	By use of the predictive method for imputing missing data , 3-month closure rates were 99 % for CAE and 96 % for RFA .
RESULTS	All primary end point analyses , which used various methods to account for the missing data rate ( 14 % ) , showed evidence to support the study 's noninferiority hypothesis ( all P < .01 ) ; some of these analyses supported a trend toward superiority ( P = .07 in the predictive model ) .
RESULTS	Pain experienced during the procedure was mild and similar between treatment groups ( 2.2 and 2.4 for CAE and RFA , respectively , on a 10-point scale ; P = .11 ) .
RESULTS	At day 3 , less ecchymosis in the treated region was present after CAE compared with RFA ( P < .01 ) .
RESULTS	Other adverse events occurred at a similar rate between groups and were generally mild and well tolerated .
CONCLUSIONS	CAE was proven to be noninferior to RFA for the treatment of incompetent GSVs at month 3 after the procedure .
CONCLUSIONS	Both treatment methods showed good safety profiles .
CONCLUSIONS	CAE does not require tumescent anesthesia and is associated with less postprocedure ecchymosis .

###25502841
BACKGROUND	This exploratory study was the first study of remimazolam in patients to assess the safety and efficacy of different single doses for procedural sedation .
METHODS	Patients scheduled to undergo a diagnostic upper gastrointestinal endoscopy were randomized to receive 1 of 3 doses of remimazolam or midazolam ( 25 per group ) in a double-blind manner .
METHODS	After a single dose of study drug to achieve sedation , patients underwent gastroscopy .
METHODS	We assessed the success of the procedure , sedation levels , recovery from sedation , and safety .
RESULTS	A single dose of remimazolam resulted in a successful procedure in 32 % , 56 % , and 64 % of patients in the low ( 0.10 ) , middle ( 0.15 ) , and high ( 0.20 mg/kg ) dose groups compared with 44 % of patients in the midazolam ( 0.075 mg/kg ) dose group .
RESULTS	The onset of sedation was 1.5 to 2.5 minutes in the remimazolam dose groups compared with 5 minutes for midazolam .
RESULTS	Because this was a single administration study , sedation could be maintained for as long as necessary to complete the procedure , using rescue midazolam or propofol .
RESULTS	Recovery from sedation was rapid for all treatment groups but was influenced by the choice of rescue medication .
RESULTS	There were no obvious differences in the safety profiles of remimazolam and midazolam .
CONCLUSIONS	This exploratory dose-finding study showed that a single administration of remimazolam ( 0.10-0 .20 mg/kg ) was capable of inducing rapid sedation with a quick recovery profile in patients undergoing a diagnostic upper gastrointestinal endoscopy .
CONCLUSIONS	The safety profile was favorable and appeared to be similar to that of midazolam , warranting further development of this short-acting compound .

###24490169
OBJECTIVE	The Solitaire Flow Restoration was approved by the FDA in 2012 for mechanical thrombolysis of proximal occlusion of intracranial arteries .
OBJECTIVE	To compare the Solitaire FR device and the Merci/Penumbra ( previously FDA approved ) systems in terms of safety , clinical outcomes , and efficacy including radiographic brain parenchymal salvage .
METHODS	Thirty-one consecutive patients treated with the Solitaire and 20 patients with comparable baseline characteristics treated with Merci or Penumbra systems were included in the study .
METHODS	Primary outcome measures included recanalization rate and modified Rankin Scale score at followup .
METHODS	Secondary outcomes included length of procedure , incidence of symptomatic intracranial hemorrhage , 90-day mortality , and radiographic analysis of percentage area salvage .
RESULTS	Compared with the Merci/Penumbra group , the Solitaire group showed a statistically significant improvement in favorable outcomes ( mRS 2 ) ( 69 % versus 35 % , P = 0.03 ) and symptomatic ICH rate ( 0 versus 15 % , P = 0.05 ) with a trend towards higher recanalization rates ( 93.5 % versus 75 % , P = 0.096 ) and shorter length of procedure ( 58.5 min versus 70.8 min , P = 0.08 ) .
RESULTS	Radiographic comparison also showed a significantly larger area of salvage in the Solitaire group ( 81.9 % versus 71.9 % , P = 0.05 ) .
CONCLUSIONS	Our study suggests that the Solitaire system allows faster , safer , and more efficient thrombectomy than Merci or Penumbra systems .

###24667658
BACKGROUND	Production and consumption of industrially processed food and drink products have risen in parallel with the global increase in overweight and obesity and related chronic non-communicable diseases .
BACKGROUND	The objective of this study was to analyze the relationship between household availability of processed and ultra-processed products and the prevalence of excess weight ( overweight plus obesity ) and obesity in Brazil .
METHODS	The study was based on data from the 2008-2009 Household Budget Survey involving a probabilistic sample of 55,970 Brazilian households .
METHODS	The units of study were household aggregates ( strata ) , geographically and socioeconomically homogeneous .
METHODS	Multiple linear regression models were used to assess the relationship between the availability of processed and ultra-processed products and the average of Body Mass Index ( BMI ) and the percentage of individuals with excess weight and obesity in the strata , controlling for potential confounders ( socio-demographic characteristics , percentage of expenditure on eating out of home , and dietary energy other than that provided by processed and ultra-processed products ) .
METHODS	Predictive values for prevalence of excess weight and obesity were estimated according to quartiles of the household availability of dietary energy from processed and ultra-processed products .
RESULTS	The mean contribution of processed and ultra-processed products to total dietary energy availability ranged from 15.4 % ( lower quartile ) to 39.4 % ( upper quartile ) .
RESULTS	Adjusted linear regression coefficients indicated that household availability of ultra-processed products was positively associated with both the average BMI and the prevalence of excess weight and obesity , whereas processed products were not associated with these outcomes .
RESULTS	In addition , people in the upper quartile of household consumption of ultra-processed products , compared with those in the lower quartile , were 37 % more likely to be obese .
CONCLUSIONS	Greater household availability of ultra-processed food products in Brazil is positively and independently associated with higher prevalence of excess weight and obesity in all age groups in this cross-sectional study .

###24378629
OBJECTIVE	SpineCor is a relatively innovative brace for non-operative treatment of adolescent idiopathic scoliosis ( AIS ) .
OBJECTIVE	However , the effectiveness of SpineCor still remains controversial .
OBJECTIVE	The objective of the current study was to compare the treatment outcomes of SpineCor brace with that of rigid brace following the standardized Scoliosis Research Society ( SRS ) criteria on AIS brace study .
METHODS	Females subjects with AIS and aged 10-14 were randomly allocated into two groups undergoing treatment of SpineCor ( S Group , n = 20 ) or rigid brace ( R Group , n = 18 ) .
METHODS	During SpineCor treatment , patients who had curve progression of > 5 would be required to switch to rigid brace treatment .
METHODS	The effectiveness of the two brace treatments was assessed using the SRS standardized criteria .
RESULTS	Before skeletal maturity , 7 ( 35.0 % ) patients in the S Group and 1 ( 5.6 % ) patient in the R Group had curve progression > 5 ( P = 0.026 ) .
RESULTS	At skeletal maturity , 5 of the 7 ( 71.4 % ) patients who failed with SpineCor bracing showed control from further progression by changing to rigid bracing .
RESULTS	At the latest follow-up with a mean duration of 45.1 months after skeletally maturity , 29.4 % of patients who were successfully treated by rigid brace showed further curve progression beyond skeletal maturity , versus 38.5 % of patients in the SpineCor group ( P > 0.05 ) .
RESULTS	For both groups , the primary curves were slightly improved at the time of brace weaning , but additionally increased at the latest follow-up , with a rate of 1.5 per year for post-maturity progression .
CONCLUSIONS	Curve progression rate was found to be significantly higher in the SpineCor group when compared with the rigid brace group .
CONCLUSIONS	Changing to rigid bracing could control further curve progression for majority of patients who previously failed with SpineCor bracing .
CONCLUSIONS	For both SpineCor and rigid brace treatments , 30-40 % of patients who were originally successfully treated by bracing would exhibit further curve progression beyond skeletal maturity .
CONCLUSIONS	The post-maturity progression rate was found to be 1.5 per year in the current study , which was relatively greater than those reported before .

###25164793
METHODS	In vitro and animal studies have shown differential colonic fermentation of structurally different prebiotics .
METHODS	We evaluated the impact of two structurally different prebiotics ( wheat bran extract ( WBE , containing arabinoxylan-oligosaccharides ) and oligofructose ) on colonic fermentation and markers of bowel health in healthy volunteers .
RESULTS	Nineteen healthy subjects completed a double-blind , cross-over randomized controlled trial .
RESULTS	Interventions with WBE , oligofructose or placebo for 2 wk ( week 1 : 15 g/day ; week 2 : 30 g/day ) were separated by 2-wk wash-out periods .
RESULTS	At the end of each study period , colonic fermentation was characterized through a metabolomics approach .
RESULTS	Fecal water genotoxicity and cytotoxicity were determined using the comet and WST-1 assay , respectively , as parameters of gut health .
RESULTS	Cluster analysis revealed differences in effects of WBE and oligofructose on colonic fermentation .
RESULTS	WBE , but not oligofructose , reduced fecal p-cresol ( p = 0.009 ) and isovaleric acid concentrations ( p = 0.022 ) , markers of protein fermentation .
RESULTS	Fecal water cytotoxicity was significantly lower after intake of WBE ( p = 0.015 ) .
RESULTS	Both WBE - and oligofructose-intake tended to reduce fecal water genotoxicity compared to placebo ( WBE : p = 0.060 ; oligofructose : p = 0.057 ) .
RESULTS	Changes in fermentation were not related to changes in fecal water toxicity .
CONCLUSIONS	Structurally different prebiotics affect colonic fermentation and gut health in a different way .

###25873050
BACKGROUND	Three decades of research suggests that prevention of iron deficiency anemia ( IDA ) in the primary care setting may be an unrealized and unique opportunity to prevent poor developmental outcomes in children .
BACKGROUND	A longitudinal study of infants with IDA showed that the developmental disadvantage persists long term despite iron therapy .
BACKGROUND	Early stages of iron deficiency , termed non-anemic iron deficiency ( NAID ) , provide an opportunity for early detection and treatment before progression to IDA .
BACKGROUND	There is little research regarding NAID , which may be associated with delayed development in young children .
BACKGROUND	The aim of this study is to compare the effectiveness of four months of oral iron treatment plus dietary advice , with placebo plus dietary advice , in improving developmental outcomes in children with NAID and to conduct an internal pilot study .
METHODS	From a screening cohort , those identified with NAID ( hemoglobin 110 g/L and serum ferritin < 14 g/L ) are invited to participate in a pragmatic , multi-site , placebo controlled , blinded , parallel group , superiority randomized trial .
METHODS	Participating physicians are part of a primary healthcare research network called TARGet Kids !
METHODS	Children between 12 and 40 months of age and identified with NAID are randomized to receive four months of oral iron treatment at 6 mg/kg/day plus dietary advice , or placebo plus dietary advice ( 75 per group ) .
METHODS	The primary outcome , child developmental score , is assessed using the Mullen Scales of Early Learning at baseline and at four months after randomization .
METHODS	Secondary outcomes include an age appropriate behavior measure ( Children 's Behavior Questionnaire ) and two laboratory measures ( hemoglobin and serum ferritin levels ) .
METHODS	Change in developmental and laboratory measures from baseline to the end of the four-month follow-up period will be analyzed using linear regression ( analysis of covariance method ) .
CONCLUSIONS	This trial will provide evidence regarding the association between child development and NAID , and the effectiveness of oral iron to improve developmental outcomes in children with NAID .
CONCLUSIONS	The sample size of the trial will be recalculated using estimates taken from an internal pilot study .
BACKGROUND	This trial was registered with Clinicaltrials.gov ( identifier : NCT01481766 ) on 22 November 2011 .

###25383369
BACKGROUND	This study prospectively evaluates and compares the treatment efficacy of botulinum toxin injection under electromyography guidance ( EMG group ) and percutaneous botulinum toxin injection under flexible fiberscopic guidance ( fiberscopy group ) .
METHODS	Thirty patients with adductor spasmodic dysphonia ( ADSD ) , who had never received treatment , were randomly allocated into EMG - or fiberscopy-guided botulinum toxin injections between March 2008 and February 2010 .
METHODS	We assessed acoustic and aerodynamic voice parameters , and the voice handicap index ( VHI ) before injection and at 1 , 3 , and 6 months after injection .
RESULTS	The mean total dosage of botulinum toxin was similar for both groups : 1.7 0.5 U for the EMG group and 1.8 0.4 U for the fiberscopy group ( P > 0.05 ) .
RESULTS	There were no significant differences in outcomes between the two groups in either the duration of effectiveness or complications such as breathy voice and aspiration .
CONCLUSIONS	Botulinum toxin injection under fiberscopic guidance is a viable alternative to EMG-guided botulinum toxin injection for the treatment of adductor spasmodic dysphonia when EMG equipment is unavailable .

###25710563
BACKGROUND	- Cell dysfunction is a core defect in T2DM , and chronic , sustained hyperglycemia has been implicated in progressive - cell failure , ie , glucotoxicity .
BACKGROUND	The aim of the present study was to examine the effect of lowering the plasma glucose concentration with dapagliflozin , a glucosuric agent , on - cell function in T2DM individuals .
METHODS	Twenty-four subjects with T2DM received dapagliflozin ( n = 16 ) or placebo ( n = 8 ) for 2 weeks , and a 75-g oral glucose tolerance test ( OGTT ) and insulin clamp were performed before and after treatment .
METHODS	Plasma glucose , insulin , and C-peptide concentrations were measured during the OGTT .
RESULTS	Dapagliflozin significantly lowered both the fasting and 2-hour plasma glucose concentrations and the incremental area under the plasma glucose concentration curve ( G0-120 ) during OGTT by -33 5 mg/dL , -73 9 mg/dL , and -60 12 mg/dL min , respectively , compared to -13 9 , -33 13 , and -18 9 reductions in placebo-treated subjects ( both P < .01 ) .
RESULTS	The incremental area under the plasma C-peptide concentration curve tended to increase in dapagliflozin-treated subjects , whereas it did not change in placebo-treated subjects .
RESULTS	Thus , C-Pep0-120 / G0-120 increased significantly in dapagliflozin-treated subjects , whereas it did not change in placebo-treated subjects ( 0.019 0.005 vs 0.002 0.006 ; P < .01 ) .
RESULTS	Dapagliflozin significantly improved whole-body insulin sensitivity ( insulin clamp ) .
RESULTS	Thus , - cell function , measured as C-Pep0-120 / G0-120 insulin resistance , increased by 2-fold ( P < .01 ) in dapagliflozin-treated vs placebo-treated subjects .
CONCLUSIONS	Lowering the plasma glucose concentration with dapagliflozin markedly improves - cell function , providing strong support in man for the glucotoxic effect of hyperglycemia on - cell function .

###25212457
BACKGROUND	Functional abdominal pain ( FAP ) is not only a highly prevalent disease but also poses a considerable burden on children and their families .
BACKGROUND	Untreated , FAP is highly persistent until adulthood , also leading to an increased risk of psychiatric disorders .
BACKGROUND	Intervention studies underscore the efficacy of cognitive behavioral treatment approaches but are limited in terms of sample size , long-term follow-up data , controls and inclusion of psychosocial outcome data .
METHODS	In a multicenter randomized controlled trial , 112 children aged 7 to 12 years who fulfill the Rome III criteria for FAP will be allocated to an established cognitive behavioral training program for children with FAP ( n = 56 ) or to an active control group ( focusing on age-appropriate information delivery ; n = 56 ) .
METHODS	Randomization occurs centrally , blockwise and is stratified by center .
METHODS	This study is performed in five pediatric gastroenterology outpatient departments .
METHODS	Observer-blind assessments of outcome variables take place four times : pre - , post - , 3 - and 12-months post-treatment .
METHODS	Primary outcome is the course of pain intensity and frequency .
METHODS	Secondary endpoints are health-related quality of life , pain-related coping and cognitions , as well as self-efficacy .
CONCLUSIONS	This confirmatory randomized controlled clinical trial evaluates the efficacy of a cognitive behavioral intervention for children with FAP .
CONCLUSIONS	By applying an active control group , time and attention processes can be controlled , and long-term follow-up data over the course of one year can be explored .
BACKGROUND	DRKS00005038 ( date : 25 July 2013 ) ; NCT02030392 ( date : 7 January 2014 ) .

###24657236
BACKGROUND	When first approved in the European Union ( EU ) , the omalizumab dosing table had upper bodyweight and IgE limits of 150kg and 700IU/mL , respectively .
BACKGROUND	In this study , we assessed the safety , pharmacokinetics ( PK ) and pharmacodynamics ( PD ) of omalizumab in patients with IgE/bodyweight combinations above those in the original dosing table .
METHODS	A multicentre , open-label , parallel-group study assessed the safety , PK and PD of omalizumab in 32 patients with mild-to-moderate allergic ( IgE-mediated ) asthma .
METHODS	Patients received two subcutaneous injections of omalizumab at one of three dosage levels ( 450 , 525 , or 600mg ) , chosen according to baseline IgE ( 300-2000IU / mL ) and bodyweight ( 40-150kg ) , with a 14-day interval between injections .
RESULTS	Overall , 69 adverse events ( AEs ) , none of them serious , were reported by 26 ( 81.3 % ) patients .
RESULTS	Analysis of laboratory measurements , vital signs and ECG data revealed no adverse findings of clinical relevance .
RESULTS	The PK profile was consistent with previous data for lower doses .
RESULTS	Mean maximum decrease of free IgE from screening was 99 % for all three doses , and mean free IgE concentrations remained < 25ng/mL for at least 2 weeks after the second dose .
RESULTS	The reductions in free IgE were consistent with levels previously associated with clinical improvements .
CONCLUSIONS	The safety and PK/PD findings from this study are consistent with previous data , and supported the extension of the omalizumab dosing table to include those patients with higher IgE/bodyweight combinations .
CONCLUSIONS	Clinical trial registry and registration number : clinicaltrials.gov ( NCT00546143 ) .

###25420830
OBJECTIVE	To test the hypothesis that the restrictive volume therapy decreases blood transfusion requirement during liver orthotopic transplantation ( OLT ) without increasing acute renal complications and hospital length stay .
METHODS	We conducted a retrospective cohort study ( n = 89 ) , randomized into 2 groups : A ( liberal fluid strategy ) and B ( restrictive therapy ) .
METHODS	We analyzed packed red blood cells ( PRBCs ) units , transfused units of fresh frozen plasma ( FFP ) , colloids , crystalloids , perioperative renal function , and hospital length stay .
METHODS	For comparison of proportions , we used the ( 2 ) test and Student t test to compare means ( parametric ) .
METHODS	A logistic regression model was constructed to evaluate the association of all these variables with probability of PRBCs transfusion .
RESULTS	In group A , 88.4 % of patients required intraoperative transfusion of PRBCs , with a mean of 8.5 7.02 IU , compared with 82.2 % in group B with a mean of 5.02 4.5 IU ( P < .001 ) .
RESULTS	We also found differences in the following variables : FFP transfusion rate was 95.3 % ( mean , 15.02 8.2 IU ) in group A and 75.6 % ( mean , 8.7 6.04 IU ) in B ( P < .001 ) .
RESULTS	The amount of colloid was 50 % ( mean , 692.8 409.6 mL ) in group A and 28.9 % ( mean , 607.6 316.7 mL ) in B ( P = .032 ) .
RESULTS	Platelet concentrates transfusion was 79.1 % ( mean , 2.05 1.1 IU ) in group A and 51.1 % ( mean , 2.0 1.08 IU ) in B ( P = .014 ) .
RESULTS	As an important effect of restrictive fluid therapy , renal function was assessed ; no differences in mean creatinine or acute renal failure in the immediate postoperative period were observed .
RESULTS	There was no difference in hospital length stay .
RESULTS	Logistic regression modelling identified 3 variables as significant predictors of transfusion : Fluid administration policy , preoperative hemoglobin and FFP units transfused .
RESULTS	Furthermore , an increase of preoperative hemoglobin is associated with a lesser probability of transfusion .
CONCLUSIONS	These results show that fluid restriction management for OLT decreased blood products requirements , especially FFP .
CONCLUSIONS	This could suggest that liberal fluid management may aggravate , rather than prevent , bleeding in these patients .
CONCLUSIONS	We did observed any no difference in failure of renal function .

###24290843
BACKGROUND	Typhoid vaccination is a public health priority in developing countries where young children are greatly affected by typhoid fever .
BACKGROUND	Because present vaccines are not recommended for children younger than 2 years , the Novartis Vaccines Institute for Global Health developed a conjugate vaccine ( Vi-CRM197 ) for infant immunisation .
BACKGROUND	We aimed to assess the immunogenicity and safety of Vi-CRM197 in participants of various ages in endemic countries in south and southeast Asia .
METHODS	We did two randomised , observer-blind , age de-escalation , phase 2 trials at two sites in Pakistan and India ( study A ) , and at one site in the Philippines ( study B ) , between March 2 , 2011 , and Aug 9 , 2012 .
METHODS	Adults aged 18-45 years , children aged 24-59 months , older infants aged 9-12 months , and infants aged 6-8 weeks were randomly assigned ( 1:1 ) with a computer-generated randomisation list ( block size of four ) to receive either 5 g Vi-CRM197 or 25 g Vi-polysaccharide vaccine ( or 13-valent pneumococcal conjugate vaccine in children younger than 2 years ) .
METHODS	Both infant populations received Vi-CRM197 concomitantly with vaccines of the Expanded Programme on Immunization ( EPI ) , according to WHO schedule .
METHODS	With the exception of designated study site personnel responsible for vaccine preparation , study investigators , those assessing outcomes , and data analysts were masked to treatment allocation .
METHODS	We specified no a-priori null hypothesis for the immunogenicity or safety objectives and all analyses were descriptive .
METHODS	Analyses were by modified intention-to-treat .
METHODS	These studies are registered with ClinicalTrials.gov , numbers NCT01229176 and NCT01437267 .
RESULTS	320 participants were enrolled and vaccinated in the two trials : 200 in study A ( all age groups ) and 120 in study B ( children and infants only ) , of whom 317 ( 99 % ) were included in the modified intention-to-treat analysis .
RESULTS	One dose of Vi-CRM197 significantly increased concentrations of anti-Vi antibody in adults ( from 113 U/mL [ 95 % CI 67-190 ] to 208 U/mL [ 117-369 ] ) , children ( 201 U/mL [ 138-294 ] to 368 U/mL [ 234-580 ] ) , and older infants ( 179 U/mL [ 129-250 ] to 249 U/mL [ 130-477 ] ) .
RESULTS	However , in children and older infants , a second dose of conjugate vaccine had no incremental effect on antibody titres and , at all ages , concentrations of antibodies increased substantially 6 months after vaccination ( from 55 U/mL [ 33-94 ] to 63 U/mL [ 35-114 ] in adults , from 23 U/mL [ 15-34 ] to 51 U/mL [ 34-76 ] in children , and from 21 U/mL [ 14-31 ] to 22 U/mL [ 14-33 ] in older infants ) .
RESULTS	Immune response in infants aged 6-8 weeks was lower than that in older participants and , 6 months after third vaccination , antibody concentrations were significantly higher than pre-vaccination concentrations in Filipino ( 21 U/mL [ 16-28 ] vs 2.88 U/mL [ 1.95-4 .25 ] ) , but not Pakistani ( 3.76 U/mL [ 2.77-5 .08 ] vs 2.77 U/mL [ 2.1-3 .66 ] ) , infants .
RESULTS	Vi-CRM197 was safe and well tolerated and did not induce any significant interference with EPI vaccines .
RESULTS	No deaths or vaccine-related serious adverse events were reported throughout the studies .
CONCLUSIONS	Vi-CRM197 is safe and immunogenic in endemic populations of all ages .
CONCLUSIONS	Given at 9 months of age , concomitantly with measles vaccine , Vi-CRM197 shows a promise for potential inclusion in EPI schedules of countries endemic for typhoid .
CONCLUSIONS	An apparent absence of booster response and a reduction in antibody titres 6 months after immunisation should be further investigated , but data show that an immunogenic typhoid vaccine can be safely delivered to infants during EPI visits recommended by WHO .
BACKGROUND	Sclavo Vaccines Association and Regione Toscana .

###25522824
BACKGROUND	Steady-state visual evoked potentials ( SSVEPs ) are widely used for brain-computer interfaces .
BACKGROUND	However , users experience fatigue due to exposure to flickering stimuli .
BACKGROUND	High-frequency stimulation has been proposed to reduce this problem .
BACKGROUND	We adapt frequency-modulated ( FM ) stimulation from the auditory domain , where it is commonly used to evoke steady-state responses , and compare the EEG as well as behavioral flicker perceptibility ratings .
METHODS	We evoke SSVEPs with a green light-emitting diode ( LED ) driven by FM signals .
RESULTS	FM-SSVEPs with different carrier and modulation frequencies can reliably be evoked with spectral peaks at the lower FM sideband .
RESULTS	Subjective perceptibility ratings decrease with increasing FM carrier frequencies , while the peak amplitude and signal-to-noise ratio ( SNR ) remain the same .
CONCLUSIONS	There are neither amplitude nor SNR differences between SSVEPs evoked rectangularly , sinusoidally or via FM .
CONCLUSIONS	Perceptibility ratings were lower for FM-SSVEPs with carrier frequencies of 20Hz and above than for sinusoidally evoked SSVEPs .
CONCLUSIONS	FM-SSVEPs seem to be beneficial for BCI usage .
CONCLUSIONS	Reduced flicker perceptibility in FM-SSVEPs suggests reduced fatigue , which leads to an enhanced user experience and performance .

###24981319
OBJECTIVE	This 24-week , placebo-controlled , double-blind , randomized study ( NCT00791921 ) investigated efficacy and safety of certolizumab pegol ( CZP ) in Japanese rheumatoid arthritis ( RA ) patients in whom methotrexate ( MTX ) can not be administered .
METHODS	A total of 230 patients were randomized to subcutaneous CZP 200 mg ( induction dosing : 400 mg at Weeks 0 , 2 and 4 ) or placebo every 2 weeks .
RESULTS	ACR20 responses with CZP were rapid and significant versus placebo at Week 1 , sustained to Week 12 ( 67.2 % vs. 14.9 % ) and Week 24 ( 63.8 % vs. 11.4 % ) .
RESULTS	Week 24-modified Total Sharp Score ( mTSS ) change from baseline ( CFB ) was 0.48 ( CZP ) versus 2.45 ( placebo ) .
RESULTS	CZP treatment was associated with higher Week 12 ACR20 responses versus placebo ( with non-MTX disease modifying antirheumatic drugs [ DMARDs ] , 74.2 % vs. 20.0 % ; without [ monotherapy ] , 59.3 % vs. 8.2 % ) and inhibition of radiographic progression at Week 24 ( mTSS CFB ; with non-MTX DMARDs , 0.24 vs. 1.61 ; monotherapy , 0.68 vs. 3.65 ) .
RESULTS	Incidences of serious adverse events were 11.2 % ( CZP ) and 2.6 % ( placebo ) ; one CZP patient died of dissecting aortic aneurysm .
CONCLUSIONS	CZP treatment with and without non-MTX DMARDs in Japanese patients in whom MTX can not be administered resulted in rapid , sustained reductions in RA signs and symptoms .
CONCLUSIONS	Notably , CZP monotherapy showed significant inhibition of radiographic progression .

###24733648
OBJECTIVE	To investigate the effects of a physiotherapy protocol on patients with pleural effusion .
METHODS	Randomized controlled trial .
METHODS	University hospital .
METHODS	A total of 104 consecutive inpatients with a medical diagnosis of pleural effusion .
METHODS	Patients were randomly allocated to a control group receiving standard treatment ( medical treatment and drainage ) or an intervention group treated with physiotherapy added to standard treatment .
METHODS	The physiotherapy programme included deep breathing exercises , mobilizations and incentive spirometry .
METHODS	Spirometric predicted values and chest radiographs were measured before treatment and at discharge and the length of hospital stay was recorded .
METHODS	Assessors were blinded to the intervention .
RESULTS	A comparative analysis showed a significant improvement of spirometric parameters in the intervention group ; pre-to-post hospitalization predicted values showed significant changes in vital capacity ( 73.1 12.6 % to 72.13 13.7 % , P < 0.001 ) , forced expiratory volume in first second ( 72.13 13.7 % to 78.98 16.9 % , P < 0.001 ) and forced expiratory flow at 25-75 % ( 64.8 35.1 % to 76.78 35.3 % , P = 0.198 ) compared to the control group that showed no significant changes across treatment .
RESULTS	The radiographic findings showed better scores on the affected side of the thorax at discharge in the physiotherapy group .
RESULTS	Length of hospital stay was also significantly ( P = 0.014 ) shorter in the intervention group ( 26.7 8.8 days ) compared to the control group ( 38.6 10.7 days ) .
CONCLUSIONS	A physiotherapy programme added to standard treatment improves the spirometric parameters and the radiological findings and reduces the hospital stay in patients with a pleural effusion .

###24735110
BACKGROUND	Geriatric evaluation and management has become standard care for community dwelling older adults following an acute admission to hospital .
BACKGROUND	It is unclear whether this approach is beneficial for the frailest older adults living in permanent residential care .
BACKGROUND	This study was undertaken to evaluate ( 1 ) the feasibility and consumer satisfaction with a geriatrician-led supported discharge service for older adults living in residential care facilities ( RCF ) and ( 2 ) its impact on the uptake of Advanced Care Planning ( ACP ) and acute health care service utilisation .
METHODS	In 2002-4 a randomised controlled trial was conducted in Melbourne , Australia comparing the geriatrician-led outreach service to usual care for RCF residents .
METHODS	Patients were recruited during their acute hospital stay and followed up at the RCF for six months .
METHODS	The intervention group received a post-discharge home visit within 96 hours , at which a comprehensive geriatric assessment was performed and a care plan developed .
METHODS	Participants and their families were also offered further meetings to discuss ACPs and document Advanced Directives ( AD ) .
METHODS	Additional reviews were made available for assessment and management of intercurrent illness within the RCF .
METHODS	Consumer satisfaction was surveyed using a postal questionnaire .
RESULTS	The study included 116 participants ( 57 intervention and 59 controls ) with comparable baseline characteristics .
RESULTS	The service was well received by consumers demonstrated by higher satisfaction with care in the intervention group compared to controls ( 95 % versus 58 % , p = 0.006 ) .
RESULTS	AD were completed by 67 % of participants/proxy decision makers in the intervention group compared to 13 % of RCF residents prior to service commencement .
RESULTS	At six months there was a significant reduction in outpatient visits ( intervention 21 ( 37 % ) versus controls 45 ( 76 % ) , ( p < 0.001 ) , but no difference in readmissions rates ( 39 % intervention versus 34 % control , p = 0.6 ) .
RESULTS	There was a trend towards reduced hospital bed-day utilisation ( intervention 271 versus controls 372 days ) .
CONCLUSIONS	It is feasible to provide a supported discharge service that includes geriatrician assessment and care planning within a RCF .
CONCLUSIONS	By expanding the service there is the potential for acute health care cost savings by decreasing the demand for outpatient consultation and further reducing acute care bed-days .

###25280132
OBJECTIVE	It is unclear whether mobile-bearing ( MB ) total knee arthroplasties reduce the risk of tibial component loosening compared to fixed-bearing ( FB ) designs .
OBJECTIVE	This randomized study investigated implant migration , periprosthetic bone mineral density ( BMD ) , and patient-reported outcomes ( Oxford knee score ) - all at 2 years-for the P.F.C. Sigma Cruciate Retaining total knee arthroplasty .
METHODS	50 osteoarthritis patients were allocated to either FB or MB tibial articulation .
CONCLUSIONS	At 2 years , the mean total translation ( implant migration ) was higher for the FB implant ( 0.30 mm , SD 0.22 ) than for the MB implant ( 0.17 mm , SD 0.09 ) ( p = 0.04 ) .
CONCLUSIONS	BMD decreased between baseline and 1-year follow-up .
CONCLUSIONS	At 2-year follow-up , BMD was close to the baseline level .
CONCLUSIONS	The knee scores of both groups improved equally well .
CONCLUSIONS	The FB tibial implant migrated more than the MB , but this was not clinically significant .
CONCLUSIONS	The mobile polyethylene presumably partly absorbs the force transmitted to the metal tibial tray , thereby reducing micromotion .

###24325987
BACKGROUND	Shoulder pain is a very common presentation in primary care .
BACKGROUND	Evidence of benefit for subacromial corticosteroid injection is inconclusive and confined largely to studies with short follow-up .
BACKGROUND	We plan a large , definitive , primary-care-based trial to determine efficacy and safety in patients with rotator cuff tendinopathy , and conducted a pilot trial to explore feasibility .
METHODS	Six general practitioners ( GPs ) from Oxfordshire , UK underwent update training in assessing painful shoulders and injecting the subacromial space .
METHODS	Each then recruited patients aged 35 to 74 years from primary care complaining of shoulder pain lasting no more than 6 months .
METHODS	Eligible participants were randomized to receive either methylprednisolone acetate 40 mg with lidocaine 1 % ( total volume 1 ml ) , or lidocaine 1 % alone ( total volume 1 ml ) , injected into the subacromial space .
METHODS	The participants were blinded to treatment allocation .
METHODS	Feasibility outcomes were rates of recruitment , withdrawal , adherence to the protocol , completeness of follow-up , and success of patient masking .
METHODS	Clinical outcomes were the Oxford Shoulder Score ( OSS ) at baseline and at 4 and 12 weeks , and responses to three satisfaction questions at 2 , 4 and 12 weeks .
METHODS	Outcome data were collected by postal questionnaires .
RESULTS	A total of 40 participants were randomized ( 80 % of the target 50 participants ) over 26 weeks giving an overall recruitment rate of 1.5 participants per week .
RESULTS	Rates of follow-up were maintained to a high level for the full 12 weeks .
RESULTS	Four participants requested a ` rescue ' corticosteroid injection but no patients withdrew .
RESULTS	The trial GPs gave high scores for their confidence that the patient had remained blinded to treatment allocation during the procedure .
RESULTS	The OSS at 4 and 12 weeks and the responses to the satisfaction questions are reported .
CONCLUSIONS	It is feasible to recruit participants with shoulder pain in the primary care setting for a blinded , randomized trial of corticosteroid injection .
CONCLUSIONS	Online randomization of participants from the practice is also feasible , and postal questionnaires provide an effective means of gathering outcome data in this area of study .
CONCLUSIONS	The lessons learned from this pilot will usefully inform the design of a large , definitive efficacy trial in primary care .
BACKGROUND	Current Clinical Trials ISRCTN82357435 .

###25015398
OBJECTIVE	To explore the cross-sectional and longitudinal relationships between fractional liver fat content , liver volume , and total liver fat burden .
METHODS	In 43 adults with non-alcoholic steatohepatitis participating in a clinical trial , liver volume was estimated by segmentation of magnitude-based low-flip-angle multiecho GRE images .
METHODS	The liver mean proton density fat fraction ( PDFF ) was calculated .
METHODS	The total liver fat index ( TLFI ) was estimated as the product of liver mean PDFF and liver volume .
METHODS	Linear regression analyses were performed .
RESULTS	Cross-sectional analyses revealed statistically significant relationships between TLFI and liver mean PDFF ( R 2 = 0.740 baseline/0 .791 follow-up , P < 0.001 baseline/P < 0.001 follow-up ) , and between TLFI and liver volume ( R 2 = 0.352 / 0.452 , P < 0.001 / < 0.001 ) .
RESULTS	Longitudinal analyses revealed statistically significant relationships between liver volume change and liver mean PDFF change ( R 2 = 0.556 , P < 0.001 ) , between TLFI change and liver mean PDFF change ( R 2 = 0.920 , P < 0.001 ) , and between TLFI change and liver volume change ( R 2 = 0.735 , P < 0.001 ) .
CONCLUSIONS	Liver segmentation in combination with MRI-based PDFF estimation may be used to monitor liver volume , liver mean PDFF , and TLFI in a clinical trial .

###25115748
BACKGROUND	Data suggest that the amygdala and hippocampus contribute to cocaine seeking and use , particularly following exposure to cocaine-related cues and contexts .
BACKGROUND	Furthermore , indices of pre-treatment cocaine-use severity have been shown to correlate with treatment outcome in cocaine-dependent patients .
METHODS	The aim of this study was to assess the relationships between amygdalar and hippocampal volumes and cocaine use before and during treatment .
METHODS	High-resolution magnetic-resonance brain images were obtained from 23 cocaine-dependent patients prior to treatment and 54 healthy comparison individuals .
METHODS	Automated segmentation of the amygdala and hippocampus images was performed in FreeSurfer .
METHODS	Cocaine-dependent patients subsequently received behavioral therapy alone or combined with contingency management as part of a treatment trial , and cocaine-use indices ( self-report , urine toxicology ) were collected .
RESULTS	Comparison participants and cocaine-dependent patients did not show significant difference in amygdalar and hippocampal volumes at pre-treatment .
RESULTS	Within the patient group , greater hippocampal volumes were correlated with more days of cocaine use before treatment and with poorer treatment outcome as indexed by shorter durations of continuous abstinence from cocaine and lower percentages of cocaine-negative urine samples during treatment .
RESULTS	Mediation analysis indicated that pre-treatment hippocampal volumes mediated the relationships between pre-treatment cocaine use and treatment outcomes .
CONCLUSIONS	The finding of a significant correlation between hippocampal volume and pre-treatment cocaine-use severity and treatment response suggests that hippocampal volume should be considered when developing individualized treatments for cocaine dependence .

###24955448
OBJECTIVE	Recent prospective studies have shown that the sequential therapy has not achieved the target Helicobacter pylori eradication rate of > 80 % in Korea .
OBJECTIVE	The aim of this study was to therefore assess the efficacy of the hybrid therapy as a first-line treatment for H.pylori eradication in a prospective trial .
METHODS	From December 2012 to August 2013 , 184 patients with confirmed H.pylori infections received either the 14-day hybrid therapy or the 14-day sequential therapy .
METHODS	Eradication outcomes were evaluated using a 13C-urea breath test at least 4 weeks after treatment cessation .
RESULTS	A total of 184 patients ( 90 receiving hybrid treatment and 94 receiving sequential treatment ) completed the study .
RESULTS	The eradication rates of the hybrid and sequential therapy groups were 81.1 % ( 73/90 ; 95 % confidence interval [ CI ] = 73.0-89 .2 % ) and 79.8 % ( 75/94 ; 95 % CI = 71.7-87 .9 % ) , respectively , by intention-to-treat analysis ( P = 0.821 ) .
RESULTS	By per protocol analysis , eradication rates were 85.9 % ( 73/85 ; 95 % CI = 78.5-93 .3 % ) and 82.0 % ( 73/89 ; 95 % CI = 74.0-89 .9 % ; P = 0.489 ) , respectively .
RESULTS	There were no significant intergroup differences in treatment compliance or discontinuation induced by severe side effects .
CONCLUSIONS	The hybrid therapy achieved acceptable eradication rate ( 85.9 % ) , but not statistically significantly higher rates than the sequential therapy ( 82.0 % ) .
CONCLUSIONS	Further studies are therefore needed to identify first-line treatments with even better eradication rates in the Korean population .

###25425373
OBJECTIVE	The purpose of this study was to quantify the time required for transvaginal cervical length measurements during a second-trimester anatomy scan and to evaluate patient attitudes regarding cervical length assessment .
METHODS	Consenting women were randomly assigned to one of the following : ( 1 ) standard arm-cervix visualized , no prespecified cervical length measurement ; ( 2 ) sequential arm-3 transabdominal cervical length measurements obtained , transvaginal sonography performed if images were inadequate or if any measurement was 3 cm or less ; and ( 3 ) screening transvaginal sonography arm-3 transvaginal cervical length measurements obtained .
METHODS	Times were recorded for the entire examination and cervical length evaluation .
METHODS	Participants completed a questionnaire at the end of their visits .
RESULTS	Sixty of 230 eligible women enrolled .
RESULTS	Demographic characteristics were similar across groups except for body mass index , which was greater in the sequential arm than the screening arm ( mean SD , 28.5 7.75 versus 24.7 3.89 kg/m ( 2 ) ; P = .03 ) .
RESULTS	There were no differences in total examination times between the 3 arms ( 24.8 8.59 versus 27.8 8.75 versus 28.5 7.78 minutes ; P = .39 ) .
RESULTS	There were no differences across groups in participant attitudes regarding examination discomfort or embarrassment .
CONCLUSIONS	Performing screening transvaginal sonography to measure cervical length did not have a statistically significant impact on the amount of time for completion of the entire examination .
CONCLUSIONS	Participants had positive responses regarding cervical length assessment by transabdominal and transvaginal sonography .

###24384495
OBJECTIVE	The objective of the study was to evaluate the efficacy of intravaginal application of 5 % 5-fluorouracil ( 5-FU ) for the treatment of cervical intraepithelial neoplasia ( CIN ) 2 in women .
METHODS	Women aged 18-29 years with CIN 2 were recruited for this randomized controlled trial of observation vs treatment with intravaginal 5-FU .
METHODS	Women in the observation group returned in 6 months for a Papanicolaou smear , colposcopy , and a human papillomavirus ( HPV ) deoxyribonucleic acid test .
METHODS	Women in the 5-FU group were treated with intravaginal 5-FU once every 2 weeks for a total of 16 weeks and were similarly evaluated at 6 months .
METHODS	All women who had a baseline visit were included in the intention-to-treat analysis .
METHODS	Values of P < .05 were considered statistically significant .
RESULTS	Between August 2010 and June 2013 , 60 women were randomized and had a baseline visit for intervention ( n = 31 ) vs observation ( n = 29 ) .
RESULTS	Of women who had cervical biopsy results at 6 months , regression of disease was demonstrated in 93 % of women in the 5-FU group ( 26 of 28 ) and 56 % of women in the observation group ( 15 of 27 ) .
RESULTS	Under the intention-to-treat analysis , a relative risk for cervical disease regression of 1.62 ( 95 % confidence interval [ CI ] , 1.10-2 .56 ) was found between the 5-FU and observation arms ( P = .01 ) .
RESULTS	When the cervical biopsy , Papanicolaou smear , and HPV results were combined for the 6 month follow-up visit , 50 % of the 5-FU group ( 14 of 28 ) had a documented normal biopsy , normal Papanicolaou smear , and negative HPV test compared with 22 % in the observation group ( 6 of 27 ) ( relative risk , 2.25 ; 95 % confidence interval , 1.05-5 .09 ; P < .05 ) .
RESULTS	There were no moderate or severe side effects in the intervention group .
CONCLUSIONS	Topical 5-FU appears to be an effective medical therapy for CIN 2 in young women .
CONCLUSIONS	5-FU is readily available and may be considered as an off-label treatment option for young women with CIN 2 who are interested in the treatment of disease but want to avoid excisional procedures .

###24479703
BACKGROUND	Pain is expected during noninvasive skin tightening and can be anxiety provoking , especially for those who have not had prior treatments .
OBJECTIVE	To compare pain reported by patients nave to nonablative skin tightening energy devices with those who were not naive .
METHODS	The non-nave group at least three nonablative laser procedures or one nonablative skin tightening procedure , and the nave group no previous treatments .
METHODS	Four sites at each of two anatomic locations ( periorbital and midface or cheek ) were treated in each subject with needle prick , pulsed dye laser , radiofrequency , and ultrasound with the order of the interventions randomized .
METHODS	All interventions except ultrasound were also applied to three abdominal sites .
METHODS	The difference in mean pain scores between nave and nonnave subjects were averaged over the anatomic sites .
RESULTS	Ten nave and 10 non-nave subjects completed study procedures .
RESULTS	Mean pain scores ranged from 1.3 to 4.9 .
RESULTS	The mean for all nave conditions was 2.3 1.0 , vs 2.2 1.4 for non-nave conditions .
RESULTS	There was no overall difference according to group , device , or anatomic area .
CONCLUSIONS	There was no significant difference in pain between nave and non-nave subjects undergoing cutaneous energy treatments .
CONCLUSIONS	Individual devices may elicit more pain at specific anatomic locations .

###24412249
OBJECTIVE	The purpose of this study was to investigate the effects of 4 weeks of custom foot orthotics on pain , disability , recurrence of spinal fixation , and muscle dysfunction in adult low back pain patients receiving limited chiropractic care .
METHODS	Adult volunteers with low back pain of greater than or equal to 1 month 's duration were randomized to receive custom orthotics ( group A ) or a flat insole sham ( group B ) with limited chiropractic care in 5 visits over 4 weeks .
METHODS	Primary outcome measures are as follows : Quadruple Numerical Pain Rating Scale ( for back ) , the Roland-Morris Disability Questionnaire , the number of muscles grade 4 or lower on manual muscle testing , and the number of spinal fixations detected by motion palpation and vertebral challenge at intake ( B1 ) , 2 weeks later before treatment began and orthotic use was initiated ( B2 ) and before each subsequent treatment at approximately days 3 , 10 , 17 , and 24 after B2 .
METHODS	Secondary outcome measures are correlations of all primary outcomes .
RESULTS	Both groups improved on all Numerical Pain Rating Scale , Roland-Morris Disability Questionnaire , and the number of muscles from intake ( B1 ) to final visit .
RESULTS	Only group B yielded significant improvements in the number of spinal fixations .
RESULTS	No outcome measures showed statistical difference between groups at any time point ; however , those who wore custom orthotics longer each day showed trends toward greater improvements in some outcome measures .
CONCLUSIONS	Both groups improved with chiropractic care including spinal manipulation ; however , there were no statistical differences shown between sham and custom orthotic groups .
CONCLUSIONS	Future studies should formally measure the time that orthotics or shams are worn in a weight-bearing capacity each day .

###25457116
OBJECTIVE	We aimed to test the effectiveness of checklists for emergency procedures on medical staff performance in intensive care crises .
METHODS	This is a prospective single-center randomized trial in a high-fidelity simulation center modeling an intensive care unit ( ICU ) in a tertiary care hospital in Germany .
METHODS	Teams consisted of 1 ICU resident and 2 ICU nurses ( in total , n = 48 ) .
METHODS	All completed 4 crisis scenarios , in which they were randomized to use checklists or to perform without any aid .
METHODS	In 2 of the scenarios , checklists could be used immediately ( type 1 scenarios ) ; and for the remaining , some further steps , for example , confirming diagnosis , were required first ( type 2 scenarios ) .
METHODS	Outcome measurements were number of predefined items and time to completion of more than 50 % and more than 75 % of steps , respectively .
RESULTS	When using checklists , participants initiated items faster and more completely according to appropriate treatment guidelines ( 9 vs 7 items with and without checklists , P < .05 ) .
RESULTS	Benefit of checklists was better in type 2 scenarios than in type 1 scenarios ( 2 vs 1 additional item , P < .05 ) .
RESULTS	In type 2 scenarios , time to complete 50 % and 75 % of items was faster with the use of checklists ( P < .005 ) .
CONCLUSIONS	Use of checklists in ICU crises has a benefit on the completion of critical treatment steps .
CONCLUSIONS	Within the type 2 scenarios , items were fulfilled faster with checklists .
CONCLUSIONS	The implementation of checklists for intensive care crises is a promising approach that may improve patients ' care .

###25728933
BACKGROUND	Rapid reversal of vitamin K antagonist ( VKA ) - induced anticoagulation is often necessary for patients needing urgent surgical or invasive procedures .
BACKGROUND	The optimum means of VKA reversal has not been established in comparative clinical trials .
BACKGROUND	We compared the efficacy and safety of four-factor prothrombin complex concentrate ( 4F-PCC ) with that of plasma in VKA-treated patients needing urgent surgical or invasive procedures .
METHODS	In a multicentre , open-label , phase 3b randomised trial we enrolled patients aged 18 years or older needing rapid VKA reversal before an urgent surgical or invasive procedure .
METHODS	We randomly assigned patients in a 1:1 ratio to receive vitamin K concomitant with a single dose of either 4F-PCC ( Beriplex/Kcentra/Confidex ; CSL Behring , Marburg , Germany ) or plasma , with dosing based on international normalised ratio ( INR ) and weight .
METHODS	The primary endpoint was effective haemostasis , and the co-primary endpoint was rapid INR reduction ( 13 at 05 h after infusion end ) .
METHODS	The analyses were intended to evaluate , in a hierarchical fashion , first non-inferiority ( lower limit 95 % CI greater than -10 % for group difference ) for both endpoints , then superiority ( lower limit 95 % CI > 0 % ) if non-inferiority was achieved .
METHODS	Adverse events and serious adverse events were reported to days 10 and 45 , respectively .
METHODS	This trial is registered at ClinicalTrials.gov , number NCT00803101 .
RESULTS	181 patients were randomised ( 4F-PCC n = 90 ; plasma n = 91 ) .
RESULTS	The intention-to-treat efficacy population comprised 168 patients ( 4F-PCC , n = 87 ; plasma , n = 81 ) .
RESULTS	Effective haemostasis was achieved in 78 ( 90 % ) patients in the 4F-PCC group compared with 61 ( 75 % ) patients in the plasma group , demonstrating both non-inferiority and superiority of 4F-PCC over plasma ( difference 143 % , 95 % CI 28-258 ) .
RESULTS	Rapid INR reduction was achieved in 48 ( 55 % ) patients in the 4F-PCC group compared with eight ( 10 % ) patients in the plasma group , demonstrating both non-inferiority and superiority of 4F-PCC over plasma ( difference 453 % , 95 % CI 319-564 ) .
RESULTS	The safety profile of 4F-PCC was generally similar to that of plasma ; 49 ( 56 % ) patients receiving 4F-PCC had adverse events compared with 53 ( 60 % ) patients receiving plasma .
RESULTS	Adverse events of interest were thromboembolic adverse events ( six [ 7 % ] patients receiving 4F-PCC vs seven [ 8 % ] patients receiving plasma ) , fluid overload or similar cardiac events ( three [ 3 % ] patients vs 11 [ 13 % ] patients ) , and late bleeding events ( three [ 3 % ] patients vs four [ 5 % ] patients ) .
CONCLUSIONS	4F-PCC is non-inferior and superior to plasma for rapid INR reversal and effective haemostasis in patients needing VKA reversal for urgent surgical or invasive procedures .
BACKGROUND	CSL Behring .

###25298158
BACKGROUND	Major depressive disorder ( MDD ) places a significant disease burden on individuals as well as on societies .
BACKGROUND	Several web-based interventions for MDD have shown to be effective in reducing depressive symptoms .
BACKGROUND	However , it is not known whether web-based interventions , when used as adjunctive treatment tools to regular psychotherapy , have an additional effect compared to regular psychotherapy for depression .
METHODS	This study is a currently recruiting pragmatic randomized controlled trial ( RCT ) that compares regular psychotherapy plus a web-based depression program ( `` deprexis '' ) with a control condition exclusively receiving regular psychotherapy .
METHODS	Adults with a depressive disorder ( N = 800 ) will be recruited in routine secondary care from therapists over the course of their initial sessions and will then be randomized within therapists to one of the two conditions .
METHODS	The primary outcome is depressive symptoms measured with the Beck Depression Inventory ( BDI-II ) at three months post randomization .
METHODS	Secondary outcomes include changes on various indicators such as anxiety , somatic symptoms and quality of life .
METHODS	All outcomes are again assessed at the secondary endpoint six months post randomization .
METHODS	In addition , the working alliance and feasibility/acceptability of the treatment condition will be explored .
CONCLUSIONS	This is the first randomized controlled trial to examine the feasibility/acceptability and the effectiveness of a combination of traditional face-to-face psychotherapy and web-based depression program compared to regular psychotherapeutic treatment in depressed outpatients in routine care .
BACKGROUND	ISRCTN20165665 .

###25215557
BACKGROUND	To the best of our knowledge , no study has examined the effects of vitamin D-calcium cosupplementation on inflammatory biomarkers and adipocytokines in vitamin D-insufficient type 2 diabetics .
OBJECTIVE	This study was performed to assess the effects of vitamin D and calcium supplementation on inflammatory biomarkers and adipocytokines in vitamin D-insufficient people with type 2 diabetes .
METHODS	Totally , 118 diabetic patients were enrolled in this randomized , placebo-controlled clinical trial .
METHODS	After matching for age , sex , body mass index , type and dose of hypoglycemic agents , and duration of diabetes , subjects were randomly assigned into 4 groups receiving the following : 1 ) 50000 IU/wk vitamin D + calcium placebo ; 2 ) 1000 mg/d calcium + vitamin D placebo ; 3 ) 50 000 IU/wk vitamin D + 1000 mg/d calcium ; or 4 ) vitamin D placebo + calcium placebo for 8 weeks .
METHODS	Blood sampling was done for the quantification of inflammatory biomarkers and adipocytokines at the study baseline and after 8 weeks of intervention .
RESULTS	Calcium ( changes from baseline : -75 19 ng/ml , P = .01 ) and vitamin D alone ( -56 19 ng/mL , P = .01 ) and joint calcium-vitamin D supplementation ( -92 19 ng/mL , P = .01 ) resulted in a significant reduction in serum leptin levels compared with placebo ( -9 18 ng/mL ) .
RESULTS	This was also the case for serum IL-6 , such that calcium ( -2 1 pg/mL , P < .001 ) and vitamin D alone ( -4 1 pg/mL , P < .001 ) and their combination ( -4 1 pg/mL , P < .001 ) led to significant reductions compared with placebo ( 3 1 pg/mL ) .
RESULTS	After adjustment for potential confounders , individuals in the calcium ( -3.1 1.3 , P < .05 ) , vitamin D ( -3.1 1.3 , P < .05 ) , and joint calcium-vitamin D groups ( -3.4 1.3 , P < .05 ) had greater reductions in serum TNF - concentrations compared with placebo ( 0.1 1.2 ) .
RESULTS	Individuals who received joint calcium-vitamin D supplements tended to have a decrease in serum high-sensitivity C-reactive protein levels compared with placebo after controlling for baseline levels ( -1.14 0.25 vs 0.02 0.24 ng/mL , P = .09 ) .
CONCLUSIONS	Joint calcium-vitamin D supplementation might improve systemic inflammation through decreasing IL-6 and TNF - concentrations in vitamin D-insufficient people with type 2 diabetes .

###25882337
BACKGROUND	There has not been sufficient data to evaluate the serial vascular healing pattern after everolimus-eluting stent ( EES ) implantation .
BACKGROUND	Using optical coherence tomography , we compared serial changes in strut coverage of the EES and the first-generation sirolimus-eluting stent ( SES ) .
METHODS	Sixty patients were randomly assigned to receive either EES ( n = 30 ) or first-generation SES ( n = 30 ) for coronary artery disease .
METHODS	Serial optical coherence tomography evaluation immediately after the procedure , and 3 - and 12-month follow-ups were performed in 50 patients with 54 stents ( 25 patients with 28 EES vs. 25 patients with 26 SES ) .
METHODS	The percentage of uncovered struts was defined as the ratio of uncovered struts to total struts .
METHODS	The primary end point was the percentage of uncovered struts at 12-month follow-up .
METHODS	The secondary primary end point was the percentage of uncovered struts at the 3-month follow-up and the comparative percentage change ( ) of uncovered struts at 3 - and 12-month follow-ups of EES vs SES .
RESULTS	The percentage of uncovered struts was significantly lower in the EES group compared with the SES group ( median value , 6.9 % ; interquartile range [ IQR ] , 3.9-10 .6 % vs. 11.1 % ; IQR , 5.5-29 .4 % , respectively ) at the 3-month follow-up ( P = 0.03 ) , and at the 12-month follow-up ( median value , 1.3 % ; IQR , 0.3-3 .5 % vs. 3.6 % ; IQR , 1.0-9 .4 % ; P = 0.02 ) .
RESULTS	The percentage of uncovered struts from the 3 - to the 12-month follow-up was similar ( -7.0 6.9 % in EES vs. -10.5 13.6 % in SES ; P = 0.24 ) .
CONCLUSIONS	The EES group showed more favourable stent strut coverage than the first-generation SES group at the early and late periods after stent implantation .
CONCLUSIONS	These findings suggest that EES have a more beneficial effect for vascular healing .

###24686045
BACKGROUND	Perineural dexamethasone has been investigated as an adjuvant for brachial plexus nerve blocks , but it is not known whether the beneficial effect of perineural dexamethasone on analgesia duration leads to a better quality of surgical recovery .
BACKGROUND	We hypothesized that patients receiving dexamethasone would have a better quality of recovery than patients not receiving dexamethasone .
BACKGROUND	We also sought to compare the effect of perineural with that of IV dexamethasone on block characteristics .
METHODS	Patients undergoing elective ankle and foot surgery were recruited over a 9-month period .
METHODS	Patients received ultrasound-guided sciatic nerve blocks by using 0.5 % bupivacaine with epinephrine 1:300,000 ( 0.45 mL/kg ) and were randomized into 3 groups : group 1 = perineural dexamethasone 8 mg/2 mL with 50 mL IV normal saline , group 2 = perineural saline/2 mL with IV 8 mg dexamethasone in 50 mL normal saline , and group 3 = perineural saline/2 mL with 50 mL normal saline .
METHODS	The primary outcome was the global score in the quality of recovery ( QoR-40 ) .
METHODS	The secondary outcomes included analgesia duration , opioid consumption , patient satisfaction , numeric pain rating scores , and postoperative neurologic symptoms .
RESULTS	Eighty patients were randomized , and 78 patients completed the study protocol .
RESULTS	There was no improvement in the global QoR-40 score at 24 hours between the perineural dexamethasone and saline , median ( 97.5 % CI ) difference of -3 ( -7 to 3 ) ; IV dexamethasone and saline , median difference of -1 ( -8 to 5 ) ; or perineural dexamethasone and IV dexamethasone median difference of -2 ( -6 to 5 ) .
RESULTS	Analgesia duration ( P < 0.001 ) and time to first toe movement ( P < 0.001 ) were prolonged by perineural dexamethasone compared with saline .
RESULTS	IV dexamethasone prolonged time to first toe movement compared with saline ( P = 0.008 ) but not analgesia duration ( P = 0.18 ) .
RESULTS	There was no significant difference in the time to first toe movement or analgesia duration between the perineural and IV dexamethasone groups .
RESULTS	Postoperative opioid consumption was not different among study groups .
RESULTS	Self-reported neurologic symptoms at 24 hours were not different among perineural dexamethasone ( 17 , 63 % ) , IV dexamethasone ( 10 , 42 % ) , or normal saline ( 8 , 30 % ) ( P = 0.31 ) .
RESULTS	All postoperative neurologic sequelae were resolved by 8 weeks .
CONCLUSIONS	Preoperative administration of IV and perineural dexamethasone compared with saline did not improve overall QoR-40 or decrease opioid consumption but did prolong analgesic duration in patients undergoing elective foot and ankle surgery and receiving sciatic nerve block .
CONCLUSIONS	Given the lack of clinical benefit and the concern of dexamethasone neurotoxicity as demonstrated in animal studies , the practice of perineural dexamethasone administration needs to be further evaluated .

###25106447
BACKGROUND	Stroke has a huge impact , leaving more than a third of affected people with lasting disability and rehabilitation remains a cornerstone treatment in the National Health Service ( NHS ) .
BACKGROUND	Recovery of mobility and arm function post-stroke occurs through re-learning to use the affected body parts and/or learning to compensate with the lesser affected side .
BACKGROUND	Promising evidence suggests that the addition of Co-careldopa to physical therapy and occupational therapy may improve the recovery of arm and leg movement and lead to improved function .
METHODS	Dopamine Augmented Rehabilitation in Stroke ( DARS ) is a multi-centre double-blind , randomised , placebo , controlled clinical trial of Co-careldopa in addition to routine NHS occupational therapy and physical therapy as part of early stroke rehabilitation .
METHODS	Participants will be randomised on a 1:1 basis to either Co-careldopa or placebo .
METHODS	The primary objective of the trial is to determine whether the addition of six weeks of Co-careldopa treatment to rehabilitation therapy can improve the proportion of patients who can walk independently eight weeks post-randomisation .
CONCLUSIONS	The DARS trial will provide evidence as to whether Co-careldopa , in addition to routine NHS occupational and physical therapy , leads to a greater recovery of motor function , a reduction in carer dependency and advance rehabilitation treatments for people with stroke .
BACKGROUND	ISRCTN99643613 assigned on 4 December 2009 .

###25075927
OBJECTIVE	A pilot study was conducted to assess the acceptability and feasibility of a breast milk expression education and support intervention in mothers of preterm infants and study procedures .
METHODS	Forty mothers of preterm infants born at less than 30 weeks of gestation .
METHODS	Pilot randomized controlled trial .
METHODS	Mothers of preterm infants were randomly allocated to the breast milk expression education and support intervention or standard care .
METHODS	The experimental intervention encompassed a breast milk expression education session on 7 themes , telephone follow-up , and telephone helpline .
METHODS	Data related to the acceptability and feasibility of the intervention and study procedures were collected throughout the study .
METHODS	At the end of the study , mothers allocated to the experimental intervention completed a self-report questionnaire assessing the acceptability of each of the intervention components .
RESULTS	It was feasible to recruit 70 % of eligible mothers and retain 83 % of mothers who consented to participate in the study .
RESULTS	Mothers reported that all the intervention components were appropriate and effective in supporting their breast milk production .
RESULTS	Although the reliability of the data collection method was demonstrated , the fidelity of the telephone follow-up faced some challenges .
CONCLUSIONS	Both the intervention and study procedures were acceptable and feasible .
CONCLUSIONS	Improvements related to the fidelity of the intervention would ensure the feasibility and internal validity of a larger-scale trial .

###24574549
OBJECTIVE	We assessed the effects of left dorsolateral prefrontal cortex transcranial direct current stimulation ( DLPF-tDCS ) on Coma Recovery Scale-Revised ( CRS-R ) scores in severely brain-damaged patients with disorders of consciousness .
METHODS	In a double-blind sham-controlled crossover design , anodal and sham tDCS were delivered in randomized order over the left DLPF cortex for 20 minutes in patients in a vegetative state/unresponsive wakefulness syndrome ( VS/UWS ) or in a minimally conscious state ( MCS ) assessed at least 1 week after acute traumatic or nontraumatic insult .
METHODS	Clinical assessments were performed using the CRS-R directly before and after anodal and sham tDCS stimulation .
METHODS	Follow-up outcome data were acquired 12 months after inclusion using the Glasgow Outcome Scale-Extended .
RESULTS	Patients in MCS ( n = 30 ; interval 43 63 mo ; 19 traumatic , 11 nontraumatic ) showed a significant treatment effect ( p = 0.003 ) as measured by CRS-R total scores .
RESULTS	In patients with VS/UWS ( n = 25 ; interval 24 48 mo ; 6 traumatic , 19 nontraumatic ) , no treatment effect was observed ( p = 0.952 ) .
RESULTS	Thirteen ( 43 % ) patients in MCS and 2 ( 8 % ) patients in VS/UWS further showed postanodal tDCS-related signs of consciousness , which were observed neither during the pre-tDCS evaluation nor during the pre - or post-sham evaluation ( i.e. , tDCS responders ) .
RESULTS	Outcome did not differ between tDCS responders and nonresponders .
CONCLUSIONS	tDCS over left DLPF cortex may transiently improve signs of consciousness in MCS following severe brain damage as measured by changes in CRS-R total scores .
METHODS	This study provides Class II evidence that short-duration tDCS of the left DLPF cortex transiently improves consciousness as measured by CRS-R assessment in patients with MCS .

###25856211
BACKGROUND	Obese men with normal semen parameters exhibit reduced fertility but few prospective data are available .
OBJECTIVE	This study aimed to determine the effect of male factors and body mass among the Pregnancy in Polycystic Ovary Syndrome II ( PPCOS II ) participants .
METHODS	This is a secondary analysis of the PPCOS II trial .
METHODS	A total of 750 infertile women with polycystic ovary syndrome ( PCOS ) were randomly assigned to up to receive five cycles of letrozole or clomiphene citrate .
METHODS	Females were 18-39-years-old and had a male partner with sperm concentration of at least 14 million/mL who consented to regular intercourse .
METHODS	Analysis was limited to couples with complete male partner information ( n = 710 ) .
RESULTS	Male body mass index ( BMI ) was higher in couples who failed to conceive ( 29.5 kg/m ( 2 ) vs 28.2 kg/m ( 2 ) ; P = .039 ) as well as those who did not achieve a live birth ( 29.5 kg/m ( 2 ) vs 28.1 kg/m ( 2 ) ; P = .047 ) .
RESULTS	At least one partner was obese in 548 couples ( 77.1 % ) .
RESULTS	A total of 261 couples were concordant for obesity ( 36.8 % ) .
RESULTS	After adjustment for female BMI , the association of male BMI with live birth was no longer significant ( odds ratio [ OR ] = 0.85 ; 95 % confidence interval [ CI ] , 0.68-1 .05 ; P = .13 ) .
RESULTS	Couples in which both partners smoked had a lower chance of live birth vs nonsmokers ( OR = 0.20 ; 95 % CI , 0.08-0 .52 ; P = .02 ) , whereas there was not a significant effect of female or male smoking alone .
RESULTS	Live birth was more likely in couples with at least three sexual intercourse attempts over the previous 4 weeks ( reported at baseline ) as opposed to couples with lesser frequency ( OR = 4.39 ; 95 % CI , 1.52-12 .4 ; P < .01 ) .
CONCLUSIONS	In this large cohort of obese women with PCOS , effect of male obesity was explained by female BMI .
CONCLUSIONS	Lower chance of success was seen among couples where both partners smoked .
CONCLUSIONS	Obesity and smoking are common among women with PCOS and their partners and contribute to a decrease in fertility treatment success .

###24756119
OBJECTIVE	To assess risk factors associated with substantial microbial bioburden of lids , conjunctivae , contact lenses , and storage cases during daily wear of silicone hydrogel contact lenses .
METHODS	Two hundred eighteen patients were fit to lotrafilcon A lenses , randomized to use either a multipurpose solution or a hydrogen peroxide care system , and followed up for 1 year .
METHODS	Lenses , lens transport saline , lids , conjunctivae , and storage cases were cultured and considered to have substantial microbial bioburden when they harbored high levels of commensal or pathogenic organisms .
METHODS	Univariate and multivariate logistic regression analyses were conducted to examine which demographic covariates were associated with significant bioburden at each location while controlling for solution use .
RESULTS	In multivariate analyses , smoking trended toward an association with lens bioburden ( odds ratio [ OR ] = 2.15 , 95 % confidence interval [ CI ] : 0.95-4 .88 ) .
RESULTS	Clerical occupations were found to be associated with more frequent overall storage case contamination ( OR = 3.51 , 95 % CI : 1.15-10 .70 ) and , specifically , higher gram-positive storage case contamination ( OR = 5.57 , 95 % CI : 1.82-17 .06 ) .
RESULTS	The peroxide system was associated with more frequent storage case contamination ( OR = 7.6 , 95 % CI : 3.79-15 .19 ) .
RESULTS	Coagulase-negative staphylococci ( CNS ) were the most frequently cultured organisms within storage cases , and in multivariate analyses , CNS were more frequently found in storage cases of peroxide users ( OR = 6.12 , 95 % CI : 2.91-13 .09 ) .
CONCLUSIONS	Clerical occupations were associated with increased microbial bioburden of storage cases during daily wear of silicone hydrogel lenses .
CONCLUSIONS	Smoking may increase the risk of lens contamination .
CONCLUSIONS	Storage cases are most frequently contaminated with normal skin flora , and peroxide cases were associated with more frequent contamination .
CONCLUSIONS	However , the solution type was not associated with lid or lens contamination nor with corneal infiltrative events in this study .

###24695080
BACKGROUND	Training-induced cognitive bias may affect performance .
BACKGROUND	Using a simulation-based emergency airway curriculum , we tested the hypothesis that curriculum design would induce bias and affect decision making .
METHODS	Twenty-three novice anesthesiology residents were randomized into 2 groups .
METHODS	The primary outcome measure was the initiation of supraglottic airway and cricothyroidotomy techniques in a simulated cannot-ventilate , cannot-intubate scenario during 3 evaluation sessions .
METHODS	Secondary outcomes were response times for device initiation .
METHODS	After a baseline evaluation and didactic lecture , residents received an initial practical training in either surgical cricothyroidotomy ( CRIC group ) or supraglottic airway ( SGA group ) .
METHODS	After the midtest , the groups switched to receive the alternate training .
RESULTS	From baseline to midtest , the SGA group increased initiation of supraglottic airway but not cricothyroidotomy .
RESULTS	The CRIC group increased initiation of cricothyroidotomy but not supraglottic airway .
RESULTS	After completion of training in both techniques , the SGA group increased initiation of both supraglottic airway and cricothyroidotomy .
RESULTS	In contrast , the CRIC group increased initiation of cricothyroidotomy but failed to change practice in supraglottic airway .
RESULTS	Final test response times showed that the CRIC group was slower to initiate supraglottic airway and faster to initiate cricothyroidotomy .
CONCLUSIONS	Practical training in only 1 technique caused bias in both groups despite a preceding didactic lecture .
CONCLUSIONS	The chief finding was an asymmetrical effect of training sequence even after training in both techniques .
CONCLUSIONS	Initial training in cricothyroidotomy caused bias that did not correct despite subsequent supraglottic airway training .
CONCLUSIONS	Educators must be alert to the risk of inducing cognitive bias when designing curricula .

###24595113
BACKGROUND	Gastric sonography can provide information about gastric content and volume that can help determine aspiration risk at the bedside .
BACKGROUND	The primary objective of this study is to assess the intrarater and interrater reliability of a previously validated method of gastric volume assessment based on gastric antral area .
BACKGROUND	The secondary objective is to evaluate the agreement between two different methods to measure gastric antral area .
METHODS	Three independent raters performed a standardized gastric ultrasound assessment in healthy subjects who had been randomly allocated to ingest a predetermined volume of clear fluid ( apple juice ) from 0 to 400 ml .
METHODS	Each rater measured the gastric antral area , using twice the two-diameter method and twice the free-tracing method .
METHODS	The rater order was allocated at random and raters were unaware of the volume ingested and of one-another 's measurements .
METHODS	The Guidelines for Reporting Reliability and Agreement Studies were followed for conducting and reporting this study .
RESULTS	Twenty-two volunteers were studied .
RESULTS	Ultrasound assessment of antral cross-sectional area and volume was found to have `` nearly perfect '' intrarater and interrater reliability ( correlation coefficient > 0.8 ) with maximum differences within 13 % .
RESULTS	A Bland-Altman analysis suggests that the free-tracing method and the two-diameter method are essentially equivalent , within a clinically acceptable level of agreement .
CONCLUSIONS	Ultrasound assessment of gastric volume by clinical anesthesiologists is highly reproducible with high intrarater and interrater reliability .
CONCLUSIONS	The free-tracing method to measure antral cross-sectional area is equivalent to the two-diameter method .

###24886027
BACKGROUND	Although childhood sexual and/or physical abuse ( CSA/CPA ) is known to have severe psychopathological consequences , there is little evidence on psychotherapeutic interventions for adolescents and young adults suffering from post-traumatic stress disorder ( PTSD ) .
BACKGROUND	Equally sparse are data on moderators of treatment response on PTSD-related epigenetic changes , health care costs and loss of productivity , alterations in cognitive processing , and on how successful interventions affect all of these factors .
BACKGROUND	Early treatment may prevent later ( co ) morbidity .
BACKGROUND	In this paper , we present a study protocol for the evaluation of a newly developed psychotherapeutic manual for PTSD after CSA/CPA in adolescents and young adults - the Developmentally Adapted Cognitive Processing Therapy ( D-CPT ) .
METHODS	In a multicenter randomized controlled trial ( RCT ) D-CPT is compared to treatment as usual ( TAU ) .
METHODS	A sample of 90 adolescent outpatients aged 14 to 21 years will be randomized to one of these conditions .
METHODS	Four assessments will be carried out at baseline , at end of treatment , and 3 and 6 months after end of therapy .
METHODS	Each time , patients will be assessed via clinical interviews and a wide range of questionnaires .
METHODS	In addition to PTSD symptoms and comorbidities , we will evaluate moderators of treatment response , epigenetic profiles , direct and indirect costs of this disorder , and neurophysiological processing of threat cues in PTSD and their respective changes in the course of these two treatments ( D-CPT and TAU ) .
CONCLUSIONS	The study will provide new insights in the understudied field of PTSD in adolescents and young adults .
CONCLUSIONS	A newly developed intervention will be evaluated in this therapeutically underserved population .
CONCLUSIONS	Results will provide data on treatment efficacy , direct and indirect treatment costs , as well as on associations of treatment outcome and PTSD intensity both to epigenetic profiles and to the neurobiological processing of threat cues .
CONCLUSIONS	Besides , they will help to learn more about the psychopathology and possible new objective correlates of PTSD .
BACKGROUND	Germanctr.de identifier : DRKS00004787 .

###25185683
BACKGROUND	Ulcerative colitis ( UC ) is associated with an increased risk of colorectal cancer .
BACKGROUND	Chromoendoscopy showed superiority to conventional colonoscopy ( CC ) in surveillance studies including high-risk patients .
BACKGROUND	We aimed to compare chromoendoscopy-guided endomicroscopy ( CGE ) with CC for intraepithelial neoplasia ( IN ) detection in patients with longstanding UC without primary sclerosing cholangitis and/or history of IN .
METHODS	One hundred sixty-two patients with longstanding ( 8 yr ) distal/extensive UC and without primary sclerosing cholangitis and/or history of IN were prospectively randomized to undergo CGE ( group A ) or CC ( group B ) .
METHODS	Seventeen patients were excluded .
METHODS	In group A ( n = 72 ) , circumscribed lesions highlighted by pan-chromoendoscopy were evaluated by endomicroscopy , and targeted biopsy/polypectomy was performed .
METHODS	In group B ( n = 73 ) , 4 random biopsies every 10 cm and targeted biopsy/polypectomy of detected lesions were performed .
RESULTS	Thirteen IN , all low grade , were detected : 7 IN in group A and 6 in group B ( P > 0.05 ) , distributed , respectively , by 6 and 4 patients ( P > 0.05 ) .
RESULTS	Significantly , more biopsies were performed in group B ( 4.7 4.9 versus 36.0 6.2 , P < 0.001 ) , and the per-biopsy yield of IN was higher in group A ( 1/48 versus 1/438 , P < 0.001 ) .
RESULTS	Examination time was 61.5 15.6 minutes in group A and 40.7 8.7 minutes in group B ( P < 0.001 ) .
RESULTS	The IN detection by endomicroscopy revealed : sensitivity = 85.7 % , specificity = 97.9 % , positive predictive value = 75.0 % , and negative predictive value = 98.9 % .
CONCLUSIONS	CGE does not improve the detection of IN in the endoscopic screening of patients with longstanding UC without primary sclerosing cholangitis and/or history of IN .
CONCLUSIONS	CGE takes longer than CC , but it decreases the number of biopsies performed and significantly increases the per-biopsy yield of IN .
CONCLUSIONS	Endomicroscopy is an accurate tool for IN detection .

###25994567
BACKGROUND	Age-associated declines in muscle mass and function are major risk factors for an impaired ability to carry out activities of daily living , falls , prolonged recovery time after hospitalization , and mortality in older adults .
BACKGROUND	New strategies that can slow the age-related loss of muscle mass and function are needed to help older adults maintain adequate performance status to reduce these risks and maintain independence .
OBJECTIVE	We evaluated the efficacy of fish oil-derived n-3 ( -3 ) PUFA therapy to slow the age-associated loss of muscle mass and function .
METHODS	Sixty healthy 60-85-y-old men and women were randomly assigned to receive n-3 PUFA ( n = 40 ) or corn oil ( n = 20 ) therapy for 6 mo. .
METHODS	Thigh muscle volume , handgrip strength , one-repetition maximum ( 1-RM ) lower - and upper-body strength , and average power during isokinetic leg exercises were evaluated before and after treatment .
RESULTS	Forty-four subjects completed the study [ 29 subjects ( 73 % ) in the n-3 PUFA group ; 15 subjects ( 75 % ) in the control group ] .
RESULTS	Compared with the control group , 6 mo of n-3 PUFA therapy increased thigh muscle volume ( 3.6 % ; 95 % CI : 0.2 % , 7.0 % ) , handgrip strength ( 2.3 kg ; 95 % CI : 0.8 , 3.7 kg ) , and 1-RM muscle strength ( 4.0 % ; 95 % CI : 0.8 % , 7.3 % ) ( all P < 0.05 ) and tended to increase average isokinetic power ( 5.6 % ; 95 % CI : -0.6 % , 11.7 % ; P = 0.075 ) .
CONCLUSIONS	Fish oil-derived n-3 PUFA therapy slows the normal decline in muscle mass and function in older adults and should be considered a therapeutic approach for preventing sarcopenia and maintaining physical independence in older adults .
CONCLUSIONS	This study was registered at clinicaltrials.gov as NCT01308957 .

###24378283
BACKGROUND	In HIV-HCV co-infected patients who failed to achieve sustained viral response ( SVR ) with PEG-IFN + RBV , data on SVR rate after re-treatment with Peginterferon ( PEG-IFN ) + ribavirin ( RBV ) are scarce .
OBJECTIVE	The aim of this study was to identify factors predictive of SVR after re-treatment in a large cohort of HIV/HCV co-infected patients - the ANRS-CO7 Ribavic cohort study , which is a long term follow-up study of patients who were included in the randomized controlled trial ANRS-HC02 RIBAVIC .
RESULTS	Among the 176 patients who did not achieve a SVR during the RIBAVIC trial , sixty-six patients ( 38 % ) experienced a re-treatment with PEG-IFN + RBV .
RESULTS	The SVR observed to the second course of HCV treatment was 44 % overall , i.e. 93 % in patients who were relapsers and 29 % in nonresponders .
RESULTS	In the nonresponders subgroup , the SVR rate was 42 % in patients with genotype 2-3 and 26 % in patients with genotype 1-4 .
RESULTS	In multivariate analysis , age 40 years ( OR 12.4 95 % CI 1.9-171 , p = 0.003 ) , genotype 2-3 versus 1-4 ( OR 8.1 95 % CI 8.1 1.2-97 , p = 0.002 ) and relapser status at first treatment ( OR 32.9 95 % CI 3.2-278 , p < 0.0001 ) were significantly associated with SVR .
CONCLUSIONS	Our findings strongly suggest that patients who relapse after first treatment , particularly those infected with HCV genotype 2-3 , or living in countries with no access to the direct acting antiviral drugs for HCV , could be successfully re-treated with standard bi-therapy of PEG-IFN + RBV regimen .

###24423203
OBJECTIVE	To evaluate two different treatment systems with regard to incisor position , transverse dimension changes in maxillary arch , changes in maxillary molar inclinations , clinical periodontal parameters , and pain intensity in patients with a Class I malocclusion .
METHODS	Seventeen patients ( with a mean age of 14.5 years ) underwent orthodontic treatment with the Roth prescribed edgewise bracket systems after expanding the maxillary arch with a quad-helix appliance , and 16 patients ( with a mean age of 14.8 years ) underwent orthodontic treatment with the Damon 3MX bracket system .
METHODS	Each subject 's lateral cephalometric and posteroanterior radiographs and dental casts were obtained at the beginning of the treatment and after debonding .
METHODS	In addition to these , the periodontal index and pain scores were taken .
RESULTS	Cephalometric data showed that in both treatment systems , overjet value decreased and maxillary and mandibular incisors proclined .
RESULTS	Posteroanterior measurements demonstrated a greater increase in the maxillary molar inclination in the Damon group .
RESULTS	Significant increase of maxillary intercanine , interpremolar , and intermolar widths was shown in both systems .
RESULTS	Periodontal index and pain score changes between different observation periods were the same .
CONCLUSIONS	The conventional and Damon systems were found similar with regard to the incisor position , transverse dimension changes in maxillary arch , clinical periodontal parameters , and pain intensity .
CONCLUSIONS	The only significant difference was that the Damon system inclined the maxillary molars more buccally than the conventional group .

###25741871
OBJECTIVE	Strategies are needed to improve medication management among vulnerable populations .
OBJECTIVE	We tested the effect of providing illustrated , plain-language medication lists on medication understanding , adherence , and satisfaction among Latino patients with diabetes in a safety net clinic .
METHODS	Randomized controlled trial .
METHODS	Intervention patients received a PictureRx illustrated medication list that depicted the medication , indication , and dosing instructions , accompanied by plain language bilingual text .
METHODS	Usual care patients received a written list of their medications in their preferred language , with indication but no images .
METHODS	Outcomes were assessed by telephone approximately 1 week later .
METHODS	The Medication Understanding Questionnaire measured patients ' ability to report the indication , strength , dosing , and frequency for their medication regimen .
METHODS	Self-reported adherence and satisfaction were secondary outcomes .
METHODS	Analysis was performed by intention to treat .
RESULTS	Of 200 enrolled participants , 197 ( 98.5 % ) completed follow-up .
RESULTS	Most ( 71 % ) had not graduated high school , and 59 % had low health literacy .
RESULTS	Patients randomized to illustrated medication instructions had better overall understanding of their medications ( P < .001 ) , including greater ability to report the drug indication ( P < .01 ) , strength ( P < .05 ) , dosing ( P < .01 ) , and frequency of administration ( P < .001 ) .
RESULTS	Self-reported adherence did not differ significantly between study groups .
RESULTS	Patients who received illustrated medication lists were very satisfied with them .
CONCLUSIONS	In this randomized controlled trial , patients who received illustrated , plain-language medication lists demonstrated significantly greater understanding of their medication regimen .
CONCLUSIONS	Such tools have the potential to improve medication use and chronic disease control , as well as reduce health disparities-although this requires further study .

###24660581
OBJECTIVE	To investigate the effect of Soothing liver therapy on infertile women undergoing in vitro fertilization and embryo transfer ( IVF-ET ) and to explore its mechanism .
METHODS	Fifty-eight women with tubal infertility were randomized into two groups : 30 in an experimental group treated with Xiaoyao powder ( Shugan ) plus gonadotropin-releasing hormone analog ( GnRHa ) / follicle-stimulating hormone ( FSH ) / human chorionic gonadotropin ( hCG ) and 28 in the control group who were treated with GnRHa/FSH / hCG only .
METHODS	The total gonadotropin ( Gn ) doses required , endometrial thickness , oocyte numbers , high quality embryo production rate and pregnancy rate of the two groups were compared .
METHODS	The concentration of growth differentiation factor-9 ( GDF-9 ) in follicular fluid was detected by western blotting and the expression of GDF-9 mRNA in granulosa cells was measured using reverse transcription-polymerase chain reaction amplification .
RESULTS	In the experimental group , the Gn dose was significantly lower than that in the control group ; the endometrial thickness , high quality embryo production and pregnancy rates were significantly higher and the expression of GDF-9 mRNA was also significantly higher than in the control group ( all P < 0.05 ) .
CONCLUSIONS	Shugan treatment can improve the pregnancy rate of women with tubal infertility ; its mechanism is possibly related to the increased expression of GDF-9 in granulosa cells .

###24747553
OBJECTIVE	To compare the effects of horizontal and vertical vaginal cuff closure techniques on vagina length after vaginal hysterectomy .
METHODS	Prospective randomized study ( Canadian Task Force classification I ) .
METHODS	Teaching and research hospital , a tertiary center .
METHODS	Fifty-two women with POP-Q stage 0 or 1 uterine prolapse were randomized into 2 groups using vertical ( n = 26 ) or horizontal ( n = 26 ) vaginal cuff closure .
METHODS	All patients underwent vaginal hysterectomy .
RESULTS	Vagina length in the 2 groups was compared preoperatively , immediately after surgery , and at 6 weeks postoperatively .
RESULTS	Mean ( SD ) preoperative vagina length in the horizontal and vertical groups was similar ( 7.87 [ 0.92 ] cm vs 7.99 [ 0.78 ] cm ; p = .41 ) .
RESULTS	Immediately postoperatively , the vagina was significantly shorter in the horizontal group than in the vertical group ( 6.61 [ 0.89 ] cm vs 7.51 [ 0.74 ] cm ; p < .001 ) .
RESULTS	At 6 weeks postoperatively , the vagina was still significantly shorter in the horizontal group ( 6.55 [ 0.89 ] cm vs 7.42 ( 0.73 ) cm ; p < .001 ) .
RESULTS	The mean difference in vagina length before and after surgery was also significantly higher in the horizontal group than in the vertical group ( -1.26 [ 0.12 ] cm vs 0.49 [ 0.11 ] cm ; p < .001 ) .
CONCLUSIONS	Vertical cuff closure during vaginal hysterectomy seems to preserve vagina length better than does horizontal cuff closure .

###25329386
BACKGROUND	Information on benefits and risks of drugs is a key element affecting doctors ' prescribing decisions .
BACKGROUND	Outreach visits promoting independent information have proved moderately effective in changing prescribing behaviours .
OBJECTIVE	Testing the short and long-term effectiveness on general practitioners ' prescribing of small groups meetings led by pharmacists .
METHODS	Two cluster open randomised controlled trials ( RCTs ) were carried out in a large scale NHS setting .
METHODS	Ad hoc prepared evidence based material were used considering a therapeutic area approach -- TEA , with information materials on osteoporosis or prostatic hyperplasia -- and a single drug oriented approach -- SIDRO , with information materials on me-too drugs of 2 different classes : barnidipine or prulifloxacin .
METHODS	In each study , all 115 Primary Care Groups in a Northern Italy area ( 2.2 million inhabitants , 1737 general practitioners ) were randomised to educational small groups meetings , in which available evidence was provided together with drug utilization data and clinical scenarios .
METHODS	Main outcomes were changes in the six-months prescription of targeted drugs .
METHODS	Longer term results ( 24 and 48 months ) were also evaluated .
RESULTS	In the TEA trial , one of the four primary outcomes showed a reduction ( prescription of alfuzosin compared to tamsulosin and terazosin in benign prostatic hyperplasia : prescribing ratio -8.5 % , p = 0.03 ) .
RESULTS	Another primary outcome ( prescription of risedronate ) showed a reduction at 24 and 48 months ( -7.6 % , p = 0.02 ; and -9,8 % , p = 0.03 ) , but not at six months ( -5.1 % , p = 0.36 ) .
RESULTS	In the SIDRO trial both primary outcomes showed a statistically significant reduction ( prescription of barnidipine -9.8 % , p = 0.02 ; prescription of prulifloxacin -11.1 % , p = 0.04 ) , which persisted or increased over time .
CONCLUSIONS	These two cluster RCTs showed the large scale feasibility of a complex educational program in a NHS setting , and its potentially relevant long-term impact on prescribing habits , in particular when focusing on a single drug .
CONCLUSIONS	National Health systems should invest in independent drug information programs .
BACKGROUND	Controlled-Trials .
BACKGROUND	com ISRCTN05866587 .

###24608161
OBJECTIVE	There are no long-term medical treatments for uterine fibroids , and non-invasive biomarkers are needed to evaluate novel therapeutic interventions .
OBJECTIVE	The aim of this study was to determine whether serial dynamic contrast-enhanced MRI ( DCE-MRI ) and magnetization transfer MRI ( MT-MRI ) are able to detect changes that accompany volume reduction in patients administered GnRH analogue drugs , a treatment which is known to reduce fibroid volume and perfusion .
OBJECTIVE	Our secondary aim was to determine whether rapid suppression of ovarian activity by combining GnRH agonist and antagonist therapies results in faster volume reduction .
METHODS	Forty women were assessed for eligibility at gynaecology clinics in the region , of whom thirty premenopausal women scheduled for hysterectomy due to symptomatic fibroids were randomized to three groups , receiving ( 1 ) GnRH agonist ( Goserelin ) , ( 2 ) GnRH agonist + GnRH antagonist ( Goserelin and Cetrorelix ) or ( 3 ) no treatment .
METHODS	Patients were monitored by serial structural , DCE-MRI and MT-MRI , as well as by ultrasound and serum oestradiol concentration measurements from enrolment to hysterectomy ( approximately 3 months ) .
RESULTS	A volumetric treatment effect assessed by structural MRI occurred by day 14 of treatment ( 9 % median reduction versus 9 % increase in untreated women ; P = 0.022 ) and persisted throughout .
RESULTS	Reduced fibroid perfusion and permeability assessed by DCE-MRI occurred later and was demonstrable by 2-3 months ( 43 % median reduction versus 20 % increase respectively ; P = 0.0093 ) .
RESULTS	There was no apparent treatment effect by MT-MRI .
RESULTS	Effective suppression of oestradiol was associated with early volume reduction at days 14 ( P = 0.041 ) and 28 ( P = 0.0061 ) .
CONCLUSIONS	DCE-MRI is sensitive to the vascular changes thought to accompany successful GnRH analogue treatment of uterine fibroids and should be considered for use in future mechanism/efficacy studies of proposed fibroid drug therapies .
CONCLUSIONS	GnRH antagonist administration does not appear to accelerate volume reduction , though our data do support the role of oestradiol suppression in GnRH analogue treatment of fibroids .
BACKGROUND	ClinicalTrials.gov NCT00746031 .

###24606094
BACKGROUND	Dysregulated chylomicron metabolism may account for hypertriglyceridemia and increased risk of cardiovascular disease in obese subjects .
BACKGROUND	Supplementation with -3 fatty acid ethyl ester ( FAEE ) decreases plasma triglyceride .
BACKGROUND	However , its effect on postprandial chylomicron metabolism in obese subjects on a weight-loss diet has not yet been investigated .
OBJECTIVE	We aimed to examine the effect of -3 FAEE supplementation on apolipoprotein ( apo ) B-48 kinetics in obese subjects on a weight-loss diet .
METHODS	We carried out a 12-week , randomized trial of a hypocaloric diet plus 4 g/d -3 FAEE supplementation ( 46 % eicosapentaenoic acid and 38 % docosahexaenoic acid ) ( n = 13 ) compared with a hypocaloric diet alone ( n = 12 ) on postprandial apoB-48 kinetics in obese subjects after ingestion of an oral load .
METHODS	The apoB-48 kinetics were determined using stable isotope tracer kinetics and multicompartmental modeling .
METHODS	We evaluated plasma total and incremental apoB-48 0 - to 10-hour area under the curves ( AUCs ) as well as apoB-48 secretion and fractional catabolic rate .
RESULTS	Weight loss with or without -3 FAEE supplementation significantly reduced body weight , total fat mass , homeostasis model assessment score , fasting triglyceride concentration , postprandial triglyceride AUC , and increased plasma high-density lipoprotein cholesterol concentration ( P < .05 in all ) .
RESULTS	Compared with weight loss alone , weight loss plus -3 FAEE significantly ( all P < .05 ) decreased fasting triglyceride ( -11 % ) , apoB-48 ( -36 % ) concentrations , postprandial triglyceride ( -21 % ) , and apoB-48 ( -22 % ) total AUCs , as well as incremental postprandial triglyceride AUCs ( -32 % ) .
RESULTS	The -3 FAEE also significantly decreased apoB-48 secretion in the basal state , without a significant effect during the postprandial period ( 3-6 hours ) .
RESULTS	The fractional catabolic rate of apoB-48 increased with both interventions with no significant independent effect of -3 FAEE supplementation .
CONCLUSIONS	Addition of -3 FAEE supplementation to a moderate weight-loss diet in obese subjects can significantly improve chylomicron metabolism by independently decreasing the secretion of apoB-48 .

###25499587
OBJECTIVE	To compare rates of Copper T380A intrauterine device ( IUD ) utilization and satisfaction with immediate versus delayed IUD insertion after cesarean delivery in Kampala , Uganda .
METHODS	This study was a randomized clinical trial of women undergoing cesarean section who desired an IUD in Kampala , Uganda .
METHODS	Participants were randomly assigned to IUD insertion at the time of cesarean delivery or 6weeks afterward .
METHODS	The primary outcome was IUD utilization at 6months after delivery .
RESULTS	Among 68 women who underwent randomization , an IUD was inserted in 100 % ( 34/34 ) of the women in the immediate insertion group and in 53 % ( 18/34 ) in the delayed group .
RESULTS	IUD use at 6 months was higher in the immediate insertion group ( 93 % vs. 50 % after delayed insertion ; p < .0001 ) .
RESULTS	Infection and expulsion were rare and did not differ between groups .
RESULTS	When we pooled both groups and looked at IUD users compared to nonusers , 91 % ( 39/43 ) of IUD users were satisfied or very satisfied with their contraceptive method compared to 44 % ( 11/25 ) of nonusers ( p < .0001 ) .
RESULTS	Women who chose not to be in the study or had the IUD removed often did so because of perceived husband or community disapproval .
CONCLUSIONS	The 6-month utilization of an IUD after immediate insertion was significantly higher than after delayed insertion without increased complications .
CONCLUSIONS	Contraceptive satisfaction was significantly higher among IUD users than nonusers .
CONCLUSIONS	Community and husband attitudes influence IUD utilization and continuation in Kampala , Uganda .
CONCLUSIONS	This work is important because it shows the safety and efficacy of providing IUDs during cesarean section in a setting where access to any healthcare , including contraception , can be extremely limited outside of childbearing and the consequences of an unintended , closely spaced pregnancy after a cesarean section can be life threatening .

###25712944
OBJECTIVE	Controversy exists over the prognostic significance of perihematomal edema ( PHE ) in intracerebral hemorrhage .
OBJECTIVE	We aimed to determine the association of early PHE and clinical outcome among participants of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial ( INTERACT ) studies .
METHODS	Pooled analyses of computed tomographic substudies in the pilot phase ( INTERACT1 ) and main phase ( INTERACT2 ) , both international , prospective , open , blinded end point , randomized controlled trials , of patients with spontaneous intracerebral hemorrhage ( < 6 hours ) and elevated systolic blood pressure , randomly assigned to intensive ( target systolic blood pressure , < 140 mm Hg ) or guideline-based ( systolic blood pressure , < 180 mm Hg ) blood-pressure management .
METHODS	Substudy participants ( n = 1310 ; 346 INTERACT1 , 964 INTERACT2 ) had blinded central analyses of digital images from standardized baseline and 24-hour computed tomography .
METHODS	Predictors of death or dependency ( modified Rankin scale scores , 3 ) at 90 days were assessed in logistic regression models and reported with odds ratios and 95 % confidence intervals .
METHODS	INTERACT studies are registered at ClinicalTrials.gov ( NCT00226096 and NCT00716079 ) .
RESULTS	Of 1138 ( 87 % ) patients with 2 CTs available for edema analysis and outcome information , time from intracerebral hemorrhage onset to baseline computed tomography , baseline hematoma volume , 24-hour hematoma growth , and intraventricular extension were independent predictors of 24-hour PHE growth .
RESULTS	Absolute growth in PHE volume was significantly associated with death or dependency ( adjusted odds ratio , 1.17 ; 95 % confidence interval , 1.02-1 .33 per 5 mL increase from baseline ; P = 0.025 ) at 90 days after adjustment for demographic , clinical , and hematoma parameter prognostic factors .
RESULTS	Associations were consistent across various sensitivity analyses .
CONCLUSIONS	PHE growth is an independent prognostic factor in intracerebral hemorrhage .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00226096 and NCT00716079 .

###25268806
BACKGROUND	To prevent or combat infection , increasing the effectiveness of the immune response is highly desirable , especially in case of compromised immune system function .
BACKGROUND	However , immunostimulatory therapies are scarce , expensive , and often have unwanted side-effects .
BACKGROUND	- glucans have been shown to exert immunostimulatory effects in vitro and in vivo in experimental animal models .
BACKGROUND	Oral - glucan is inexpensive and well-tolerated , and therefore may represent a promising immunostimulatory compound for human use .
METHODS	We performed a randomized open-label intervention pilot-study in 15 healthy male volunteers .
METHODS	Subjects were randomized to either the - glucan ( n = 10 ) or the control group ( n = 5 ) .
METHODS	Subjects in the - glucan group ingested - glucan 1000 mg once daily for 7 days .
METHODS	Blood was sampled at various time-points to determine - glucan serum levels , perform ex vivo stimulation of leukocytes , and analyze microbicidal activity .
RESULTS	- glucan was barely detectable in serum of volunteers at all time-points .
RESULTS	Furthermore , neither cytokine production nor microbicidal activity of leukocytes were affected by orally administered - glucan .
CONCLUSIONS	The present study does not support the use of oral - glucan to enhance innate immune responses in humans .
BACKGROUND	ClinicalTrials.gov NCT01727895 .

###26001894
OBJECTIVE	To investigate if contact lens-related discomfort is a function of the time of day at which lenses are worn .
METHODS	This was a randomized , crossover , open-label clinical trial where subjective responses , with and without contact lenses , were assessed every 2 hours during five stages ( A to E ) .
METHODS	Each stage began at the time when subjects would normally have inserted their contact lenses ( T0 ) .
METHODS	During stage A , no lenses were worn , whereas in stage B , lenses were worn continuously for 12 hours .
METHODS	In stages C to E , lenses were worn for only 4 hours .
METHODS	Contact lenses were inserted at T0 for stage C , but for stages D and E , lenses were not inserted until T0 + 4 and T0 + 8 hours , respectively .
METHODS	Mixed linear models were used for statistical analysis .
RESULTS	In the absence of contact lenses , ocular comfort and dryness remained reasonably constant throughout the observation period .
RESULTS	Ocular comfort and dryness decreased during 12 hours of continuous lens wear and became significantly worse from the 8-hour time onward compared with insertion ( p < 0.023 ) .
RESULTS	There were no significant differences in terms of ocular comfort and dryness between any of the 4-hour lens wear stages ( p < 0.82 ) .
RESULTS	During each 4-hour stage , both comfort and dryness behaved in a similar fashion ( p > 0.05 ) to the first 4 hours of continuous contact lens wear .
RESULTS	Comparing the scores of each of these stages with the no-lens response at the corresponding time showed no significant differences for comfort ( p > 0.23 ) or dryness ( p > 0.37 ) .
CONCLUSIONS	Short periods of wear can be experienced at any time of day without significant change in ocular discomfort and dryness .
CONCLUSIONS	This suggests that subjective responses at the end of the day are determined by the length of time lenses are in contact with the eye , rather than the time of day at which lenses are worn .

###25618971
OBJECTIVE	To investigate a quantitative method for using radial artery pulse waveforms to assess the effect of pulsatile flow during cardiopulmonary bypass ( CPB ) .
METHODS	A total of 34 adults with heart disease who underwent open-heart surgery between April 2010 and January 2011 were randomized into a pulsatile perfusion group ( n = 17 ) and a non-pulsatile perfusion group ( n = 17 ) .
METHODS	Radial arterial pulse waveforms of pulsatile and non-pulsatile perfusion patients were observed and compared before and during CDB .
RESULTS	No pulse waveform could be detected at patients ' radial artery in both groups when the aorta was cross-clamped .
RESULTS	Pulse waveforms could be detected at pulsatile perfusion patients ' radial artery , but could not be detected at non-pulsatile perfusion patients ' radial artery during CPB .
RESULTS	Additionally , patients ' pulse waveforms during pulsatile perfusion were lower than those before the operation .
CONCLUSIONS	Our findings indicate that radial artery sphygmogram can be used as a valid indicator to evaluate the effectiveness of pulsatile perfusion during CPB .

###24760951
BACKGROUND	The Internet is an optimal setting to provide massive access to tobacco treatments .
BACKGROUND	To evaluate open-access Web-based smoking cessation programs in a real-world setting , adherence and retention data should be taken into account as much as abstinence rate .
OBJECTIVE	The objective was to analyze the usage and effectiveness of a fully automated , open-access , Web-based smoking cessation program by comparing interactive versus noninteractive versions .
METHODS	Participants were randomly assigned either to the interactive or noninteractive version of the program , both with identical content divided into 4 interdependent modules .
METHODS	At baseline , we collected demographic , psychological , and smoking characteristics of the smokers self-enrolled in the Web-based program of Universidad Nacional de Educacin a Distancia ( National Distance Education University ; UNED ) in Madrid , Spain .
METHODS	The following questionnaires were administered : the anxiety and depression subscales from the Symptom Checklist-90-Revised , the 4-item Perceived Stress Scale , and the Heaviness of Smoking Index .
METHODS	At 3 months , we analyzed dropout rates , module completion , user satisfaction , follow-up response rate , and self-assessed smoking abstinence .
RESULTS	A total of 23,213 smokers were registered , 50.06 % ( 11,620 / 23,213 ) women and 49.94 % ( 11,593 / 23,213 ) men , with a mean age of 39.5 years ( SD 10.3 ) .
RESULTS	Of these , 46.10 % ( 10,701 / 23,213 ) were married and 34.43 % ( 7992/23 ,213 ) were single , 46.03 % ( 10,686 / 23,213 ) had university education , and 78.73 % ( 18,275 / 23,213 ) were employed .
RESULTS	Participants smoked an average of 19.4 cigarettes per day ( SD 10.3 ) .
RESULTS	Of the 11,861 smokers randomly assigned to the interactive version , 2720 ( 22.93 % ) completed the first module , 1052 ( 8.87 % ) the second , 624 ( 5.26 % ) the third , and 355 ( 2.99 % ) the fourth .
RESULTS	Completion data was not available for the noninteractive version ( no way to record it automatically ) .
RESULTS	The 3-month follow-up questionnaire was completed by 1085 of 23,213 enrolled smokers ( 4.67 % ) .
RESULTS	Among them , 406 ( 37.42 % ) self-reported not smoking .
RESULTS	No difference between groups was found .
RESULTS	Assuming missing respondents continued to smoke , the abstinence rate was 1.74 % ( 406/23 ,213 ) , in which 22,678 were missing respondents .
RESULTS	Among follow-up respondents , completing the 4 modules of the intervention increased the chances of smoking cessation ( OR 1.95 , 95 % CI 1.27-2 .97 , P < .001 ) , as did smoking 30 minutes ( OR 1.58 , 95 % CI 1.04-2 .39 , P = .003 ) or 1 hour after waking ( OR 1.93 , 95 % CI 1.27-2 .93 , P < .001 ) compared to smoking within the first 5 minutes after waking .
CONCLUSIONS	The findings suggest that the UNED Web-based smoking cessation program was very accessible , but a high level of attrition was confirmed .
CONCLUSIONS	This could be related to the ease of enrollment , its free character , and the absence of direct contact with professionals .
CONCLUSIONS	It is concluded that , in practice , the greater the accessibility to the program , the lower the adherence and retention .
CONCLUSIONS	Professional support from health services and the payment of a reimbursable fee could prevent high rates of attrition .

###25500941
BACKGROUND	Stroke volume variation ( SVV ) and pulse pressure variation ( PPV ) , termed dynamic markers of preload responsiveness , may predict the response to i.v. fluid in critically ill patients .
BACKGROUND	However , the predictive accuracy of these variables during gastrointestinal surgery remains uncertain .
METHODS	Observational study of patients aged 50 yr undergoing major gastrointestinal surgery , enrolled in the OPTIMISE trial .
METHODS	Patients received six 250 ml fluid challenges with i.v. colloid solution ( three during and three after surgery ) , while SVV and PPV were measured using the LiDCOrapid monitor ( LiDCO Ltd , UK ) .
METHODS	Fluid responsiveness was defined as a stroke volume increase 10 % .
METHODS	Area under the receiver operating characteristic curve was calculated with 95 % confidence intervals .
METHODS	Adjustment for covariates was performed by regression modelling and a clustering method was used to adjust for intra-patient correlation .
RESULTS	One hundred patients were recruited between August 2010 and October 2012 .
RESULTS	Five hundred and fifty-six fluid challenges were administered and 159 ( 28.6 % ) were associated with increased stroke volume .
RESULTS	The predictive value of both variables was poor during surgery [ SVV 0.69 ( 0.63-0 .77 ) ; PPV 0.70 ( 0.62-0 .77 ) ] , and also after surgery [ SVV 0.69 ( 0.63-0 .78 ) ; PPV 0.64 ( 0.56-0 .73 ) ] .
RESULTS	The findings were similar when analysed according to whether patients were mechanically ventilated [ SVV 0.68 ( 0.63-0 .77 ) ; PPV 0.69 ( 0.61-0 .77 ) ] or breathing spontaneously [ SVV 0.69 ( 0.61-0 .77 ) ; PPV 0.63 ( 0.56-0 .72 ) ] .
RESULTS	Predictive value improved slightly in a sensitivity analysis excluding outlier values of SVV and PPV .
CONCLUSIONS	In this study , the predictive accuracy of SVV and PPV for fluid responsiveness was insufficient to recommend for routine clinical use during or after major gastrointestinal surgery .

###25826644
OBJECTIVE	To report the 6-month comparative outcomes and bleb morphology for needle revision with bevacizumab and mitomycin C ( MMC ) versus MMC alone of failed trabeculectomy and ExPRESS shunt blebs .
METHODS	Patients undergoing bleb needle revision procedures were enrolled in this study .
METHODS	All patients received a subconjunctival injection of 0.1 mL MMC ( 0.4 mg/mL ) mixed with 0.1 mL preservative-free lidocaine ( 1 % ) at the beginning of the procedure .
METHODS	The patients were randomized into 2 cohorts assigned to receive either 1.0 mg ( 0.04 mL of 25 mg/mL ) subconjunctival bevacizumab ( treatment group ) or 0.04 mL of balanced salt solution ( control group ) injected in an identical manner posterior to the bleb after the bleb needling .
METHODS	Success was defined as 20 % reduction in intraocular pressure ( IOP ) without any IOP-lowering medications .
METHODS	Qualified success was defined as 20 % reduction of IOP with IOP-lowering medications .
METHODS	Failure was defined as IOP > 21 mm Hg , IOP reduction < 20 % , or need for additional surgery .
METHODS	Bleb morphology was classified using the Indiana Bleb Appearance Grading Scale .
RESULTS	Six months postoperatively , in treatment group ( n = 29 ) , 57 % of patients achieved complete success , and 43 % failed .
RESULTS	In control group ( n = 29 ) , 41 % of patients achieved complete success , 7 % achieved qualified success , and 52 % failed .
RESULTS	The difference in success rates between the 2 groups was not statistically significant ( P = 0.35 ) .
RESULTS	At 6 months , the mean IOP was 11.52 in treatment group and 12.83 in control group ( P = 0.45 ) ; patients in treatment group were on a mean of 0.16 medications as compared with 0.58 medications in control group ( P = 0.058 ) .
RESULTS	For bleb morphology of treatment group compared with control group , the blebs had less vascularity ( 0.76 vs. 1.20 , respectively , on a scale of 0 to 4 , P < 0.05 ) and greater extent ( 2.68 vs. 2.36 , on a scale of 0 to 3 , P = 0.022 ) in treatment group .
CONCLUSIONS	There was no significant difference between the success rates and IOPs at postoperative month 6 between treatment and control groups .
CONCLUSIONS	Postoperative blebs in the treatment group were less vascular and had greater extent .

###24931228
BACKGROUND	Venous thromboembolism ( VTE ) is an important complication after major orthopedic surgery .
BACKGROUND	Pharmaceutical methods represent the main strategy of VTE prevention .
BACKGROUND	The use of aspirin in VTE prevention is still controversial worldwide , especially in China .
BACKGROUND	The purpose of this study was to evaluate the role of aspirin combined with mechanical measures in the prevention of VTE after total knee arthroplasty ( TKA ) .
METHODS	Between January 2012 and May 2013 and in accordance with the inclusion criteria , 120 patients undergoing TKA were randomly allocated to two groups .
METHODS	To prevent VTE , patients in group A received aspirin combined with mechanical measures postoperatively , while patients in group B received low-molecular-weight heparin ( LMWH ) sodium and rivaroxaban sequentially in combination with mechanical measures postoperatively .
METHODS	All surgeries were performed by one surgeon using a posterior-stabilized cemented prosthesis .
METHODS	The two groups were followed up and compared for the incidence of deep vein thrombosis ( DVT ) by duplex ultrasound scan and clinical VTE events .
METHODS	The adverse events , the blood loss index , and the cost of VTE prevention were also compared .
RESULTS	DVT was detected in 10 of 60 patients in group A ( 16.7 % , 95 % CI : 7.3 % -26.1 % ) compared with 11 of 60 in group B ( 18.3 % , 95 % CI : 8.5 % -27.8 % ) ( P = 0.500 ) .
RESULTS	There is no statistical evidence supporting the inferior effect of aspirin in preventing DVT as compared with the other medications .
RESULTS	There were no cases of symptomatic VTE or death during the follow-up period .
RESULTS	Area of ecchymosis was lower in group A than in group B , and the differences were statistically significant .
RESULTS	Patients in group A had the lower blood loss index as compared with patients in group B. No transfusion cases were found in both groups .
RESULTS	The differences were statistically significant .
RESULTS	The cost of VTE prevention analysis indicated a cost reduction using aspirin in group A compared with using LMWH and rivaroxaban in group B.
CONCLUSIONS	Aspirin combined with mechanical measures had a good effect on prevention of VTE after TKA and resulted in lower cost , less blood loss , and less subcutaneous ecchymosis .

###24373830
BACKGROUND	Catheter-related infections ( CRIs ) caused by peripheral intravenous catheters ( PIVCs ) are an increasingly common iatrogenic complication .
BACKGROUND	To prevent this , recommended timelines for routine replacement of PIVCs have increased from 48 h to 72 h and subsequently to 96 h , despite a lack of supporting scientific evidence .
OBJECTIVE	To compare closed-system ( COS ) PIVCs with open-system ( MOS ) PIVCs .
METHODS	This prospective , randomized controlled trial compared the indwell time of COS PIVCs without complications with that of MOS PIVCs , removed only by clinical indication .
METHODS	In total , 1199 PIVCs ( 642 inpatients ) were randomized and 283 PIVCs were cultured .
METHODS	Sixteen catheters ( 11 patients ) were lost to the study after randomization .
RESULTS	In total , 104,469 catheter-hours ( 54,173 h in 584 COS and 50,296 h in 599 MOS ) were recorded .
RESULTS	The median dwell time was 137.1 h for COS PIVCs and 96 h for MOS PIVCs ( P = 0.001 ) .
RESULTS	Among PIVCs in place for 24 h , the median dwell time was 144.5 h for COS PIVCs [ 95 % confidence interval ( CI ) 123.4-165 .6 ] and 99 h for MOS PIVCs ( 95 % CI 87.2-110 .8 ) .
RESULTS	Use of COS PIVCs reduced phlebitis rates by 29 % ( 31 vs 45 cases/1000 catheter-days ; P = 0.004 ) .
RESULTS	The probability that a MOS PIVC would last for 96 h was 79.9 % , and the probability that a COS PIVC would last for 144 h was 80.4 % .
RESULTS	There were no significant differences in rates of bacterial colonization per 1000 catheter-days ( 51.1 COS vs 54.1 MOS ) or CRI ( 5.76 COS vs 6.65 MOS ) .
RESULTS	Nevertheless , there was a 20 % relative risk reduction in CRI .
CONCLUSIONS	Use of COS PIVCs reduced episodes of phlebitis and risk of infection at a cost of only 0.09 / day .
CONCLUSIONS	When PIVCs are replaced based on clinical indication , COS PIVCs last for up to 144 h and MOS PIVCs last for up to 96 h without increased risk and with significant cost savings ( 786,257 / year/1000 beds ) .

###24973841
BACKGROUND	Hypertension is a global health problem .
BACKGROUND	Multiple classes of drugs including angiotensin receptor blockers ( ARBs ) are available for the treatment of hypertension .
BACKGROUND	Olmesartan is a relatively newer ARB used in hypertension management .
OBJECTIVE	To assess the efficacy and safety of WIN-BP ( Olmesartan 20mg/40mg ) tablet in Indian patients with hypertension .
METHODS	An open label , non-comparative , multi-centric , real world post marketing observational study included Indian adult hypertensive patients who were treated with olmesartan 20mg/40mg tablet once daily for six months .
METHODS	The primary outcome was reduction of systolic blood pressure ( SBP ) to < 140mmHg and diastolic BP ( DBP ) to < 90mmHg at 3 and 6 months after initiation of treatment with olmesartan .
METHODS	All reported adverse events were recorded .
RESULTS	A total of 8940 patients were enrolled in this study .
RESULTS	Baseline SBP of 164mmHg was reduced to 153 , 145 , 134 and 130mmHg at the end of 15 days , 1 , 3 and 6 months respectively .
RESULTS	Similarly , baseline DBP of 100mmHg was reduced to 93 , 89 , 84 and 82mmHg at the end of 15 days , 1 , 3 and 6 months respectively .
RESULTS	The reduction in both systolic and diastolic blood pressure from day 15 to month 6 was statistically significant ( p < 0.0001 ) with olmesartan treatment .
RESULTS	The percentage of responders for both systolic and diastolic blood pressure increased consistently from day 15 to month 6 .
RESULTS	Only 0.08 % patients reported the adverse events .
RESULTS	No serious adverse event was reported in the study .
CONCLUSIONS	Olmesartan 20mg/40mg is effective and well tolerated without any serious adverse events in patients with hypertension .

###25308537
OBJECTIVE	We suggest an alternative chest compression ( CC ) in kneeling posture using a ` kneeling stool ' on which the performer kneels beside the patient on a bed in-hospital .
OBJECTIVE	In kneeling posture , we can maintain high quality cardiopulmonary resuscitation ( CPR ) without the bed height adjustment , which is necessary and inconvenient in standing posture .
METHODS	This study is a randomised crossover trial with 38 participants working in one ED .
METHODS	The first group knelt on the kneeling stool beside a manikin placed on a bed , whereas the second group stood on a step stool with the manikin at knee level using bed height adjustment .
METHODS	All the participants performed continuous chest compression for 5 min without audio-visual feedback .
METHODS	After that , the posture was changed in each group .
METHODS	The parameters of CC quality ( CC depth , rate , accuracy , and incomplete chest recoil ) , visual analogue scale ( VAS ) for fatigue and pain , and preference of participants were compared between the two groups .
RESULTS	The data of 33 participants in both postures were analysed following exclusion of five participants .
RESULTS	In the comparisons overall and per minute between the two postures , the parameters and VAS do not differ significantly ( all P > 0.05 ) except for the median 1st CC rate that was faster in kneeling posture than in standing posture , P = 0.01 ) .
RESULTS	Twenty-three performers preferred the kneeling posture .
CONCLUSIONS	A kneeling posture with a kneeling stool were preferred by participants , which have shown similar results in CC parameters and VAS with a standing posture on a stepstool with bed height adjustment during in-hospital CPR .

###24588631
OBJECTIVE	The purpose of this study was to establish , using a quasi-experimental design , whether 2 family risk factors , parental psychological dysfunction and nonsupportive parenting , during preadolescence could longitudinally predict elevated sympathetic nervous system ( SNS ) activity 9 years later , and to determine whether participation in an efficacious family centered prevention program could moderate these associations if they emerged .
METHODS	Rural African American preadolescents ( N = 476 ) were assigned randomly to the Strong African American Families ( SAAF ) program or to a control condition .
METHODS	When youths were 11 years of age ( M = 11.2 years ) , primary caregivers provided data on their own depressive symptoms and self-esteem , and youths provided data on their receipt of nonsupportive parenting .
METHODS	When the youths were 20 years of age , indicators of SNS activity , the catecholamines epinephrine and norepinephrine , were assayed from their overnight urine voids .
RESULTS	Parental psychological dysfunction and nonsupportive parenting forecast elevated catecholamine levels for youths in the control condition , but not for those in the SAAF condition .
CONCLUSIONS	The demonstration that a prevention program can induce reduction of catecholamine levels is important from both theoretical and public health perspectives , because it shows that the developmental progression from family risk factors to heightened sympathetic nervous system activity is not immutable .

###25037617
OBJECTIVE	The technical performance score ( TPS ) has been reported in a single center study to predict the outcomes after congenital cardiac surgery .
OBJECTIVE	We sought to determine the association of the TPS with outcomes in patients undergoing the Norwood procedure in the Single Ventricle Reconstruction trial .
METHODS	We calculated the TPS ( class 1 , optimal ; class 2 , adequate ; class 3 , inadequate ) according to the predischarge echocardiograms analyzed in a core laboratory and unplanned reinterventions that occurred before discharge from the Norwood hospitalization .
METHODS	Multivariable regression examined the association of the TPS with interval to first extubation , Norwood length of stay , death or transplantation , unplanned postdischarge reinterventions , and neurodevelopment at 14 months old .
RESULTS	Of 549 patients undergoing a Norwood procedure , 356 ( 65 % ) had an echocardiogram adequate to assess atrial septal restriction or arch obstruction or an unplanned reintervention , enabling calculation of the TPS .
RESULTS	On multivariable regression , adjusting for preoperative variables , a better TPS was an independent predictor of a shorter interval to first extubation ( P = .019 ) , better transplant-free survival before Norwood discharge ( P < .001 ; odds ratio , 9.1 for inadequate vs optimal ) , shorter hospital length of stay ( P < .001 ) , fewer unplanned reinterventions between Norwood discharge and stage II ( P = .004 ) , and a higher Bayley II psychomotor development index at 14 months ( P = .031 ) .
RESULTS	The TPS was not associated with transplant-free survival after Norwood discharge , unplanned reinterventions after stage II , or the Bayley II mental development index at 14 months .
CONCLUSIONS	TPS is an independent predictor of important outcomes after Norwood and could serve as a tool for quality improvement .

###25497258
BACKGROUND	Quality improvement is central to improving the care of patients with cardiovascular disease ; however , the optimum type of data feedback to support such efforts is unknown .
METHODS	Over 26 months , 149 eligible Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With The Guidelines hospitals were randomized to receive either standard ( n = 76 control ) or targeted ( n = 73 intervention ) performance feedback reports for acute myocardial infarction patient care .
METHODS	Each report summarized performance on identified metrics ( providing hospitals with detailed data on their 3 lowest-performing quality metrics , relative to their peers ) .
METHODS	Intervention sites received 5 targeted feedback reports .
METHODS	Overall composite performance was compared between cohorts at end of study and as a change from baseline .
RESULTS	Intervention ( n = 60 ) and control ( n = 64 ) hospitals that completed the study had similar baseline performance ( median score 83.7 % vs 84.2 % ) .
RESULTS	Over 26 months of follow-up , the change in overall composite score across hospitals was neutral ( median 0.1 % [ interquartile range { IQR } -2.4 % to 3.3 % ] ) .
RESULTS	There was no difference in observed improvement in either the intervention ( median -0.2 % [ IQR-2 .6 % to 3.3 % ] ) or control ( median 0.1 % [ IQR -2.2 % to 3.4 % ] ) hospitals .
CONCLUSIONS	We were unable to demonstrate that targeted performance feedback reports lead to more rapid care improvements than standard reports .
CONCLUSIONS	Future directions should explore the relationship between hospital self-selection of targeted metrics and the identification and promulgation of less common metrics -- particularly those that reflect processes of care .

###25144550
OBJECTIVE	The use of the incentive spirometer ( IS ) and expiratory positive airway pressure ( EPAP ) provides several benefits in patients with respiratory disorders .
OBJECTIVE	However , the effects of the use of these devices coupled ( IS+EPAP ) are still unknown in asthmatic patients .
OBJECTIVE	The aim of this study was to evaluate the effect of IS associated with EPAP on exercise tolerance ( six-minute walk test - 6MWT ) , lung function ( by spirometry ) , asthma control ( Asthma Control Questionnaire - ACQ ) and quality of life ( Asthma Quality of Life Questionnaire - AQLQ ) in patients with severe asthma .
METHODS	Patients were randomised into two groups : IS+EPAP ( n = 8 ) and control ( n = 6 ) .
METHODS	The IS+EPAP group performed breathing exercises at home , twice daily for 20min , over a period of 5 weeks .
RESULTS	There was no significant difference in spirometric variables and in the distance walked in the 6MWT in both groups .
RESULTS	However , the IS+EPAP group showed an improvement in asthma control ( p = 0.002 ) and quality of life ( p = 0.02 ) .
CONCLUSIONS	These findings demonstrate that the IS+EPAP protocol , when performed at home , provides an improvement in asthma control and quality of life for patients with severe asthma when evaluated by ACQ and AQLQ , respectively .

###24831116
BACKGROUND	The aim of this study was to test the effect different unstable footwear constructions have on centre of pressure motion when standing .
METHODS	Sixteen young female volunteers were tested in five conditions , three unstable footwear ( Reebok Easy-Tone , FitFlop and Skechers Shape-Ups ) , a standard shoe and barefoot in a randomised order .
METHODS	Double and single leg balance on a force plate was assessed via centre of pressure excursions and displacements in each condition .
RESULTS	For double leg and single leg standing centre of pressure excursions in the anterior-posterior direction were significantly increased wearing Skechers Shape-Ups compared to barefoot and the standard shoe .
RESULTS	For the Reebok Easy Tone during single leg standing excursions in the anterior-posterior direction were significantly greater compared to the barefoot condition .
RESULTS	Cumulative displacement of the centre of pressure in medial-lateral direction increased significantly during single leg standing when wearing Skechers Shape-Ups compared to barefoot and standard shoe as well as for Reebok Easy Tone vs. barefoot .
CONCLUSIONS	It would appear from these quiet standing results that the manner of the construction of instability shoes effects the CoP movement which is associated with induced instability .
CONCLUSIONS	Greater CoP excursion occurred in the A-P direction while the cumulative displacements were greater in the M-L direction for those shoes with the rounded sole and soft foam and those with airpods .
CONCLUSIONS	The shoe construction with altered density foam did not induce any change in the CoP movement , during quite standing , which tends to suggest that it is not effective at inducing balance .
CONCLUSIONS	Not all instability shoes are effective in altering the overall instability of the wearer .

###25219130
OBJECTIVE	To observe the clinical effect of cupping combined with acupuncture stimulation of trigger points on lumbar myofascial pain syndrome ( MPS ) .
METHODS	Sixty MPS patients were randomly divided into acupuncture + TDP group ( n = 30 ) , and cupping + acupuncture group ( n = 30 ) .
METHODS	Patients in the acupuncture + TDP group were treated by acupuncture stimulation of trigger points and local TDP irradiation , and patients of the cupping + acupuncture group treated by intensive cupping applied to the myofascial band and acupuncture stimulation of the locus according to the position of muscular tension band .
METHODS	The therapeutic effects were assessed according to the score of the McGill pain questionnaire composing of pain rating index ( PRI ) , visual analogue scale ( VAS ) and present pain intensity ( PPI ) before , immediately and 1 month after the treatment .
RESULTS	After the treatment , the total effective rates of the acupuncture + TDP and cupping + acupuncture groups were 83.3 % ( 25/30 ) and 96.6 % ( 29/30 ) , respectively , without significant difference between the two groups ( P > 0.05 ) .
RESULTS	One month 's follow-up showed that the total effective rates of the acupuncture + TDP and cupping + acupuncture groups were 40.0 % and 90.0 % respectively , and the latter group was significantly better than the acupuncture + TDP group in the therapeutic effect ( P < 0.05 ) .
RESULTS	The scores of PRI , VAS , PPI after the treatment were markedly decreased in both groups ( P < 0.05 ) .
RESULTS	One month later , the scores of PRI , VAS and PPI in the cupping + acupuncture group were obviously lower than those of the acupuncture group ( P < 0.05 ) .
CONCLUSIONS	Both acupuncture stimulation of trigger points plus TDP and cupping plus acupuncture can effectively relieve pain in MPS patients , while the therapeutic effect of cupping plus acupuncture treatment lasts longer analgesic effect .

###24733990
OBJECTIVE	The efficacy of cognitive behavioral therapy for insomnia ( CBT-I ) has been suggested for insomnia concomitant with depression , but its impact on quality of life ( QoL ) has not been adequately evaluated .
OBJECTIVE	The study aimed to determine which aspects of QoL could be affected by CBT-I and how any changes in QoL were mediated by changes in insomnia and depression .
METHODS	We conducted a 4-week randomized controlled trial with 4-week follow-up in outpatient clinics in Japan .
METHODS	Thirty-seven patients with DSM-IV diagnosis of major depressive disorder concomitant with chronic insomnia were randomly assigned to the treatment-as-usual ( TAU ) alone arm or the TAU with brief behavioral therapy for insomnia ( TAU plus psychotherapy ) arm using modified CBT-I consisting of 4 weekly individual sessions .
METHODS	We evaluated QoL using norm-based scoring of the Short Form-36 at baseline and at 8 weeks .
METHODS	We also examined associations between QoL subscales and remission in insomnia or depression while controlling for baseline scores of the entire sample .
RESULTS	We tested group effects while controlling for baseline scores .
RESULTS	TAU plus psychotherapy resulted in significantly better scores on physical functioning ( p = 0.006 ) , social functioning ( p = 0.002 ) , and mental health ( p = 0.041 ) subscales than TAU alone at 8 weeks .
RESULTS	Patients with either remitted insomnia or depression showed higher QoL scores than non-remitted patients ; scores approximated those within the normal range .
CONCLUSIONS	For patients with insomnia in depression , adding CBT-I to TAU can produce substantive benefits in some aspects of QoL .
BACKGROUND	ClinicalTrials.gov Identifier : NCT00610259 , http://www.clinicaltrials.gov/ .

###25144827
BACKGROUND	The feasibility of an interventional clinical trial in idiopathic pulmonary fibrosis ( IPF ) using death and hospitalization as primary end points is an area of uncertainty .
BACKGROUND	Using data from a large well-characterized clinical trial population , this article aims to illustrate the impact of cohort enrichment and study duration on sample size requirements for IPF clinical trials in which death alone or death plus hospitalization serve as the primary end point .
METHODS	Event rate estimates for death and hospitalization were determined from patients enrolled in National Institutes of Health-sponsored IPF Clinical Research Network clinical trials .
METHODS	Standard equations were applied to estimate the total sample size required for varying gender , age , and pulmonary function ( GAP ) stage-based cohorts .
RESULTS	Risk estimates for death and hospitalization in the clinical trial cohort were substantially lower than those published .
RESULTS	An IPF trial with death as its primary end point enrolling subjects designated as GAP stage 1 and 2 over 1 year with a minimum follow-up of 1 year would require an estimated 7,986 subjects to achieve 90 % power for a hazard ratio of 0.70 .
RESULTS	Alternatively , an IPF trial with death plus hospitalization as its primary end point enrolling subjects with GAP stage 2 and 3 over 2 years with a minimum follow-up of 1 year would require an estimated 794 subjects for the same power and hazard ratio .
CONCLUSIONS	Study design decisions , in particular cohort enrichment strategies , have a substantial impact on sample size requirements for IPF clinical trials using time-to-event primary end points such as death and death plus hospitalization .

###25142032
BACKGROUND	Epidermal growth factor ( EGF ) is an important growth factor in regulation of cell proliferation , differentiation , survival and apoptosis .
BACKGROUND	Studies showed that food-grade Lactococcus lactis ( L. lactis ) and NICE expression system have superior performance in exogenous protein expression .
BACKGROUND	This study aimed to construct and express porcine EGF ( pEGF ) , and use L. lactis as vehicle for producing and delivering pEGF .
BACKGROUND	Furthermore , investigating biological activity of pEGF and exploring applications feasibility of combination effects of L. lactis and pEGF on early weaned piglets ' production .
RESULTS	A recombinant Lactococcus lactis which produced and secreted pEGF at 1000 ng/ml in culture supernatant was generated .
RESULTS	Secreted pEGF was a fully biologically active protein , as demonstrated by its capacity to stimulate L929 mouse fibroblast cell line proliferation in vitro .
RESULTS	For in vivo study , forty piglets were randomly allocated to control , antibiotic control , empty vector-expressing L. lactis ( LL-EV ) and pEGF-secreting L. lactis ( LL-pEGF ) .
RESULTS	After 14 d of rearing , final body weight and average daily gain in LL-pEGF were greater ( P < 0.05 , 8.95 vs. 8.37 kg , 206.1 vs. 157.7 g/day , respectively ) than those in control , but no significant differences between LL-pEGF , LL-EV and antibiotic control .
RESULTS	Overall period average daily feed intake was higher in LL-pEGF , LL-EV and antibiotic control than in control ( P < 0.05 , 252.9 , 255.6 , 250.0 , 207.3 g/day , respectively ) .
RESULTS	No significant difference was observed on ADFI/ADG .
RESULTS	LL-pEGF increased villous height in the duodenum , jejunum and ileum than in control and LL-EV ( P < 0.05 ) .
RESULTS	Sucrase in the 3 intestinal segments , aminopeptidase A in the duodenum and Jejunum , aminopeptidase N and dipeptidase IV in the duodenum in LL-pEGF were higher than those in control ( P < 0.05 ) .
RESULTS	Furthermore , Escherichia coli and Enterococcus counts decreased in the ileum and Lactobacillus increased in the ileum and cecum digesta in LL-pEGF compare with the control ( P < 0.05 ) .
RESULTS	Lactobacillus increased in the cecum in LL-EV compared with control and antibiotic control ( P < 0.05 ) .
CONCLUSIONS	We have generated a recombinant Lactococcus lactis which produced and secreted fully biologically active porcine EGF .
CONCLUSIONS	Oral administration of pEGF-secreting L. lactis had beneficial effects on intestinal health and performance of early-weaned piglets .

###24288121
OBJECTIVE	Sequence-dependent improved efficacy of topoisomerase I followed by topoisomerase 2 inhibitors was assessed in a randomized phase II study in extensive-stage small-cell lung cancer ( SCLC ) .
METHODS	Patients with previously untreated extensive-stage SCLC with measurable disease , ECOG performance status of 0-3 and stable brain metastases were eligible .
METHODS	Arm A consisted of topotecan ( 0.75 mg/m ( 2 ) ) on days 1 , 2 and 3 , etoposide ( 70 mg/m ( 2 ) ) and cisplatin ( 20 mg/m ( 2 ) ) ( PET ) on days 8 , 9 and 10 in a 3-week cycle .
METHODS	Arm B consisted of irinotecan ( 50 mg/m ( 2 ) ) and cisplatin ( 20 mg/m ( 2 ) ) on days 1 and 8 followed by etoposide ( 85 mg/m ( 2 ) PO bid ) on days 3 and 10 ( PIE ) in a 3-week cycle .
RESULTS	We enrolled 140 patients and randomized 66 eligible patients to each arm .
RESULTS	Only 54.5 % of all patients completed the planned maximum 6 cycles .
RESULTS	There were grade 3 treatment-related adverse events in approximately 70 % of the patients on both arms including 6 treatment-related grade 5 events .
RESULTS	The overall response rates ( CR + PR ) were 69.7 % ( 90 % CI 59.1-78 .9 , 95 % CI 57.1-80 .4 % ) for arm A and 57.6 % ( 90 % CI 46.7-67 .9 , 95 % CI 44.8-69 .7 % ) for arm B.
RESULTS	The median progression-free survival and overall survival were 6.4 months ( 95 % CI 5.4-7 .5 months ) and 11.9 months ( 95 % CI 9.6-13 .7 months ) for arm A and 6.0 months ( 95 % CI 5.4-7 .0 months ) and 11.0 months ( 95 % CI 8.6-13 .1 months ) for arm B.
CONCLUSIONS	Sequential administration of topoisomerase inhibitors did not improve on the historical efficacy of standard platinum-doublet chemotherapy for extensive-stage SCLC .

###24477817
BACKGROUND	Atrial fibrillation is associated with inflammation and oxidative stress .
OBJECTIVE	Carvedilol and N-acetyl cysteine ( NAC ) combination decreases inflammation , oxidative stress , and postoperative atrial fibrillation ( POAF ) rates more than metoprolol or carvedilol .
METHODS	Preoperative and postoperative total oxidative stress ( TOS ) , total antioxidant capacity ( TAC ) , and white blood cells ( WBC ) were measured in metoprolol , carvedilol , or carvedilol plus NAC groups , and association with POAF was evaluated .
RESULTS	Preoperative TAC , TOS , and WBC levels were similar among the groups .
RESULTS	Postoperative TAC levels were lower in the metoprolol group compared with the carvedilol group ( 1.0 vs 1.4 ) or the carvedilol plus NAC group ( 1.0 vs 1.9 ) and were also lower in the carvedilol group compared with the carvedilol plus NAC group ( all P < 0.0001 ) .
RESULTS	Postoperative TOS levels were higher in the metoprolol group as compared with the carvedilol ( 29.6 vs 24.2 ; P < 0.0001 ) or the carvedilol plus NAC groups ( P < 0.0001 ) , and were also higher in the carvedilol group as compared with the carvedilol plus NAC group ( 24.2 vs 19.3 ; P < 0.0001 ) .
RESULTS	Postoperative WBC counts were lower in the carvedilol plus NAC group compared with the metoprolol group ( 12.9 vs 14.8 ; P = 0.004 ) , were similar between the carvedilol and the metoprolol groups ( 13 vs 14.8 ) and between the carvedilol plus NAC group and the carvedilol group ( both P > 0.05 ) .
RESULTS	Postoperative TAC , TOS , and WBC were associated with POAF .
CONCLUSIONS	Carvedilol plus NAC reduced oxidative stress and inflammation compared with metoprolol and decreased oxidative stress compared with carvedilol .
CONCLUSIONS	Postoperative TAC , TOS , and WBC were associated with POAF .

###24353113
BACKGROUND	The issue on timing and number of bile sampling for exfoliative bile cytology is still unsettled .
METHODS	A total of 100 patients with cholangiocarcinoma undergoing resection after external biliary drainage were randomized into two groups : a 2-day group where bile was sampled five times per day for 2 days ; and a 10-day group where bile was sampled once per day for 10 days ( registered University Hospital Medical Information Network/ID 000005983 ) .
METHODS	The outcome of 87 patients who underwent laparotomy was analyzed , 44 in the 2-day group and 43 in the 10-day group .
RESULTS	There were no significant differences in patient characteristics between the two groups .
RESULTS	Positivity after one sampling session was significantly lower in the 2-day group than in the 10-day group ( 17.0 3.7 % vs. 20.7 3.5 % , P = 0.034 ) .
RESULTS	However , cumulative positivity curves were similar and overlapped each other between both groups .
RESULTS	The final cumulative positivity by the 10th sampling session was 52.3 % in the 2-day group and 51.2 % in the 10-day group .
RESULTS	We observed a small increase in cumulative positivity after the 5th or 6th session in both groups .
CONCLUSIONS	Bile cytology positivity is unlikely to be affected by sample time .

###25686338
OBJECTIVE	To identify nasal width changes occurring after Le Fort I osteotomy and to compare prospectively the effect of three surgical techniques for controlling postoperative nasal width .
METHODS	In the study , 79 patients ( 22 male and 57 female , mean age 23.2 3.4 years ) , who received Le Fort I osteotomy at Peking University Hospital of Stomatology from 2011 to 2014 , were randomly divided into three groups .
METHODS	Group 1 was treated with traditional intraoral alar base cinch suture ( ABCS ) ; Group 2 with extraoral ABCS , and Group 3 with traditional ABCS plus an extra intraoral suture at points G.lat .
METHODS	All the patients had taken 3D photos using 3dMD camera before operation , and 3 , and 6 months after operation .
METHODS	The nasal widths , which were indicated as distances between Sbal-Sbal , G.lat-G .
METHODS	lat and Al-Al , were measured by two examiners in the 3D photos three times with a time-interval of one week .
METHODS	SPSS 13.0 was used to do the statistic analysis .
RESULTS	At the end of the postoperative 6 months , the nasal widths lessened as compared with the postoperative 3 months .
RESULTS	No significant differences were found between the three groups 6 months after the operation .
RESULTS	The degree of the postoperative nasal width widening had positive correlation with that of the intraoperative nasal width widening , and had negative correlation with the initial nasal width and the amount of post-suture narrowing .
CONCLUSIONS	There is no difference between three suturing techniques for controlling nasal width widening after Le Fort I osteotomy .
CONCLUSIONS	The postoperative nasal width-widening ca n't be totally avoided , and the alteration might last at least 6 months after the operation .
CONCLUSIONS	For patients with narrow nasal width and need to move maxilla forward , more overcorrection of ABCS is needed to control the postoperative nasal base widening .

###24285336
OBJECTIVE	To examine physical activity ( PA ) thresholds affecting glucose , insulin and lipid concentrations and body fat composition in high-risk patients for type 2 diabetes ( T2D ) .
METHODS	A total of 113 subjects of both genders having abnormal glucose levels in the oral glucose tolerance test were contacted .
METHODS	A total of 78 subjects with age 58.810.4 years and body mass index 31.75.3 kgm ( -2 ) were randomly assigned to intervention and control groups .
METHODS	INTERVENTION consisted of a supervised walking ( 60min three times weekly ) for 3 months .
METHODS	All the subjects received standard care for PA and weight reduction and wore an accelerometer during the whole wakeful time .
RESULTS	Over 80 % of the daily steps clustered at an acceleration level of 0.3-0 .7 g ( 2-3kmh ( -1 ) of walking ) and were 5870 in the intervention and 4434 in the control group ( P < 0.029 ) .
RESULTS	Between 0 and 3 months no significant changes were observed in fasting and 2-h glucose , body weight or maximal oxygen uptake .
RESULTS	In contrast , changes in fasting and 2-h insulin ( -3.4 mUl ( -1 ) , P = 0.035 and -26.6 , P = 0.003 , respectively ) , homeostasis model assessment-estimated insulin resistance ( -1.0 , P = 0.036 ) , total cholesterol ( -0.55 mmoll ( -1 ) , P = 0.041 ) , low-density lipoprotein ( LDL ) cholesterol ( -0.36 mmoll ( -1 ) , P = 0.008 ) and visceral fat area ( -5.5 cm ( 2 ) , P = 0.030 ) were significantly greater in the intervention than in control subjects .
RESULTS	The overall effects of PA were analyzed by quartiles of daily steps of all subjects .
RESULTS	There were significant reductions in total and LDL cholesterol and visceral fat area between the highest ( daily steps over 6520 ) and the lowest quartile ( 1780-2810 daily steps ) .
RESULTS	The changes associated with PA remained significant after adjustments of baseline , sex , age and body weight change .
CONCLUSIONS	Habitual and structured PAs with the acceleration levels of 0.3-0 .7 g and daily steps over 6520 , equivalent to walking at 2-3kmh ( -1 ) for 90min daily , standing for the relative PA intensity of 30-35 % of the maximal oxygen uptake , are clinically beneficial for overweight/obese and physically inactive individuals with a high risk for T2D .

###25044819
BACKGROUND	Palliative care incorporates comprehensive support of family caregivers because many of them experience burden and distress .
BACKGROUND	However , evidence-based support initiatives are few .
OBJECTIVE	We evaluated a one-to-one psychoeducational intervention aimed at mitigating the distress of caregivers of patients with advanced cancer receiving home-based palliative care .
OBJECTIVE	We hypothesised that caregivers would report decreased distress as assessed by the General Health Questionnaire ( GHQ ) .
METHODS	A randomised controlled trial comparing two versions of the delivery of the intervention ( one face-to-face home visit plus telephone calls versus two visits ) plus standard care to a control group ( standard care only ) across four sites in Australia .
RESULTS	Recruitment to the one visit condition was 57 , the two visit condition 93 , and the control 148 .
RESULTS	We previously reported non-significant changes in distress between times 1 ( baseline ) and 2 ( 1-week post-intervention ) but significant gains in competence and preparedness .
RESULTS	We report here changes in distress between times 1 and 3 ( 8-week post-death ) .
RESULTS	There was significantly less worsening in distress between times 1 and 3 in the one visit intervention group than in the control group ; however , no significant difference was found between the two visit intervention and the control group .
CONCLUSIONS	These results are consistent with the aim of the intervention , and they support existing evidence demonstrating that relatively short psychoeducational interventions can help family caregivers who are supporting a dying relative .
CONCLUSIONS	The sustained benefit during the bereavement period may also have positive resource implications , which should be the subject of future inquiry .

###25173535
BACKGROUND	Biodegradable polymers for release of antiproliferative drugs from metallic drug-eluting stents aim to improve long-term vascular healing and efficacy .
BACKGROUND	We designed a large scale clinical trial to compare a novel thin strut , cobalt-chromium drug-eluting stent with silicon carbide-coating releasing sirolimus from a biodegradable polymer ( O-SES , Orsiro ; Biotronik , Blach , Switzerland ) with the durable polymer-based Xience Prime/Xpedition everolimus-eluting stent ( EES ) ( Xience Prime/Xpedition stent , Abbott Vascular , IL ) in an all-comers patient population .
METHODS	The multicenter BIOSCIENCE trial ( NCT01443104 ) randomly assigned 2,119 patients to treatment with biodegradable polymer sirolimus-eluting stents ( SES ) or durable polymer EES at 9 sites in Switzerland .
METHODS	Patients with chronic stable coronary artery disease or acute coronary syndromes , including non-ST-elevation and ST-elevation myocardial infarction , were eligible for the trial if they had at least 1 lesion with a diameter stenosis > 50 % appropriate for coronary stent implantation .
METHODS	The primary end point target lesion failure ( TLF ) is a composite of cardiac death , target vessel myocardial infarction , and clinically driven target lesion revascularization within 12 months .
METHODS	Assuming a TLF rate of 8 % at 12 months in both treatment arms and accepting 3.5 % as a margin for noninferiority , inclusion of 2,060 patients would provide more than 80 % power to detect noninferiority of the biodegradable polymer SES compared with the durable polymer EES at a 1-sided type I error of 0.05 .
METHODS	Clinical follow-up will be continued through 5 years .
CONCLUSIONS	The BIOSCIENCE trial will determine whether the biodegradable polymer SES is noninferior to the durable polymer EES with respect to TLF .

###25825006
BACKGROUND	Asthma guidelines recommend monitoring of asthma control .
BACKGROUND	However , in a substantial proportion of children , asthma is poorly controlled and the best monitoring strategy is not known .
OBJECTIVE	We studied two monitoring strategies for their ability to improve asthma outcomes in comparison with standard care ( SC ) : web-based monthly monitoring with the ( Childhood ) Asthma Control Test ( ACT or C-ACT ) and 4-monthly monitoring of FENO .
METHODS	In this randomised controlled , partly blinded , parallel group multicentre trial with a 1-year follow-up , children aged 4-18 with a doctor 's diagnosis of asthma treated in seven hospitals were randomised to one of the three groups .
METHODS	In the web group , treatment was adapted according to ACT obtained via a website at 1-month intervals ; in the FENO group according to ACT and FENO , and in the SC group according to the ACT at 4-monthly visits .
METHODS	The primary endpoint was the change from baseline in the proportion of symptom-free days ( SFD ) .
RESULTS	Two-hundred and eighty children ( mean age 10.4 years , 66 % boys ) were included ; 268 completed the study .
RESULTS	Mean changes from baseline in SFD were similar between the groups : -2.1 % ( web group , n = 90 ) , +8.9 % ( FENO group , n = 91 ) versus 0.15 % ( SC , n = 87 ) , p = 0.15 and p = 0.78 .
RESULTS	Daily dose of inhaled corticosteroids ( ICS ) decreased more in the web-based group compared with both other groups ( -200 g/day , p < 0.01 ) , while ACT and SFD remained similar .
CONCLUSIONS	The change from baseline in SFD did not differ between monitoring strategies .
CONCLUSIONS	With web-based ACT monitoring , ICS could be reduced substantially while control was maintained .
BACKGROUND	NTR 1995 .

###24955752
OBJECTIVE	Depressive symptoms are common in schizophrenia and can worsen outcomes and increase suicide risk .
OBJECTIVE	Lurasidone is an atypical antipsychotic agent indicated for the treatment of schizophrenia and for the treatment of major depressive episodes associated with bipolar I disorder .
OBJECTIVE	This post hoc analysis evaluated the effect of lurasidone on depressive symptoms in patients with schizophrenia .
METHODS	Patient-level data were pooled from 4 similarly designed , double-blind , placebo-controlled , 6-week registration studies of lurasidone ( 40-160 mg/d ) in adult patients with an acute exacerbation of schizophrenia .
METHODS	Changes in depressive symptoms , measured by the Montgomery-sberg Depression Rating Scale ( MADRS ) , were analyzed for the overall sample and for subgroups of patients stratified by baseline MADRS scores .
RESULTS	MADRS assessments at baseline and endpoint ( day 42 or last observation carried forward [ LOCF ] ) were available for 1330 patients .
RESULTS	Patients receiving lurasidone experienced significantly greater decreases in MADRS score ( -2.8 , least-squares [ LS ] mean change , LOCF ) compared with patients receiving placebo ( -1.4 , P < .001 , effect size 0.24 ) .
RESULTS	Analysis of change in MADRS score ( LOCF ) by baseline symptom severity ( MADRS score of 12 , 14 , 16 , 18 ) showed significantly greater improvement for lurasidone-treated patients across all severity groups ; effect sizes ranged from 0.25 to 0.34 .
RESULTS	Among patients with a baseline MADRS score of 12 , depressive symptom remission ( defined as MADRS score < 10 at LOCF endpoint ) was attained by 45.0 % of lurasidone-treated patients and 36.3 % of patients receiving placebo ( P < .05 ) .
CONCLUSIONS	In a pooled analysis of short-term , placebo-controlled studies , lurasidone significantly improved depressive symptoms in patients with schizophrenia .

###25409371
BACKGROUND	Early enteral feeding through a nasoenteric feeding tube is often used in patients with severe acute pancreatitis to prevent gut-derived infections , but evidence to support this strategy is limited .
BACKGROUND	We conducted a multicenter , randomized trial comparing early nasoenteric tube feeding with an oral diet at 72 hours after presentation to the emergency department in patients with acute pancreatitis .
METHODS	We enrolled patients with acute pancreatitis who were at high risk for complications on the basis of an Acute Physiology and Chronic Health Evaluation II score of 8 or higher ( on a scale of 0 to 71 , with higher scores indicating more severe disease ) , an Imrie or modified Glasgow score of 3 or higher ( on a scale of 0 to 8 , with higher scores indicating more severe disease ) , or a serum C-reactive protein level of more than 150 mg per liter .
METHODS	Patients were randomly assigned to nasoenteric tube feeding within 24 hours after randomization ( early group ) or to an oral diet initiated 72 hours after presentation ( on-demand group ) , with tube feeding provided if the oral diet was not tolerated .
METHODS	The primary end point was a composite of major infection ( infected pancreatic necrosis , bacteremia , or pneumonia ) or death during 6 months of follow-up .
RESULTS	A total of 208 patients were enrolled at 19 Dutch hospitals .
RESULTS	The primary end point occurred in 30 of 101 patients ( 30 % ) in the early group and in 28 of 104 ( 27 % ) in the on-demand group ( risk ratio , 1.07 ; 95 % confidence interval , 0.79 to 1.44 ; P = 0.76 ) .
RESULTS	There were no significant differences between the early group and the on-demand group in the rate of major infection ( 25 % and 26 % , respectively ; P = 0.87 ) or death ( 11 % and 7 % , respectively ; P = 0.33 ) .
RESULTS	In the on-demand group , 72 patients ( 69 % ) tolerated an oral diet and did not require tube feeding .
CONCLUSIONS	This trial did not show the superiority of early nasoenteric tube feeding , as compared with an oral diet after 72 hours , in reducing the rate of infection or death in patients with acute pancreatitis at high risk for complications .
CONCLUSIONS	( Funded by the Netherlands Organization for Health Research and Development and others ; PYTHON Current Controlled Trials number , ISRCTN18170985 . )

###25445314
BACKGROUND	An explicit goal of Patient Aligned Care Teams ( PACTs ) within the Veterans Health Administration is to promote continuity of care in primary care clinics and thereby reduce Emergency Department ( ED ) utilization ; however , there has been little research to guide PACTs on how to accomplish this .
OBJECTIVE	The overall goal of this study is to examine the impact of a primary care-based nurse telephone support program [ DISPO ED ] on Veterans treated and released from the ED who are at high risk for repeat visits .
METHODS	This study is a two group randomized , controlled trial to evaluate DISPO ED for Veterans treated and released from the ED who are at high risk for repeat visits .
METHODS	We define high risk as those who have had an ED visit or hospitalization during the 6 month period before the index ED visit and have 2 chronic conditions .
METHODS	Veterans are randomized to nurse telephone support or usual care .
METHODS	The primary outcome is repeat ED use within 30 days ; secondary outcomes are patient satisfaction with care and total costs .
CONCLUSIONS	The results of this randomized , controlled trial with an Effectiveness-Implementation Type I Hybrid design will be directly relevant to the care of more than 500,000 high risk patients seen in Veterans ' Affairs Medical Center ( VAMC ) EDs annually .
CONCLUSIONS	Results will also be informative to health systems outside VA aiming to reduce ED use through accountable care organizations .

###26376136
BACKGROUND	Sequelae of severe neonatal hyperbilirubinemia constitute a substantial disease burden in areas where effective conventional phototherapy is unavailable .
BACKGROUND	We previously found that the use of filtered sunlight for the purpose of phototherapy is a safe and efficacious method for reducing total bilirubin .
BACKGROUND	However , its relative safety and efficacy as compared with conventional phototherapy are unknown .
METHODS	We conducted a randomized , controlled noninferiority trial in which filtered sunlight was compared with conventional phototherapy for the treatment of hyperbilirubinemia in term and late-preterm neonates in a large , urban Nigerian maternity hospital .
METHODS	The primary end point was efficacy , which was defined as a rate of increase in total serum bilirubin of less than 0.2 mg per deciliter per hour for infants up to 72 hours of age or a decrease in total serum bilirubin for infants older than 72 hours of age who received at least 5 hours of phototherapy ; we prespecified a noninferiority margin of 10 % for the difference in efficacy rates between groups .
METHODS	The need for an exchange transfusion was a secondary end point .
METHODS	We also assessed safety , which was defined as the absence of the need to withdraw therapy because of hyperthermia , hypothermia , dehydration , or sunburn .
RESULTS	We enrolled 447 infants and randomly assigned 224 to filtered sunlight and 223 to conventional phototherapy .
RESULTS	Filtered sunlight was efficacious on 93 % of treatment days that could be evaluated , as compared with 90 % for conventional phototherapy , and had a higher mean level of irradiance ( 40 vs. 17 W per square centimeter per nanometer , P < 0.001 ) .
RESULTS	Temperatures higher than 38.0 C occurred in 5 % of the infants receiving filtered sunlight and in 1 % of those receiving conventional phototherapy ( P < 0.001 ) , but no infant met the criteria for withdrawal from the study for reasons of safety or required an exchange transfusion .
CONCLUSIONS	Filtered sunlight was noninferior to conventional phototherapy for the treatment of neonatal hyperbilirubinemia and did not result in any study withdrawals for reasons of safety .
CONCLUSIONS	( Funded by the Thrasher Research Fund , Salt Lake City , and the National Center for Advancing Translational Sciences of the National Institutes of Health ; Clinical Trials.gov number , NCT01434810 . )

###24626980
OBJECTIVE	To assess any changes in the Functional Communicative Profile ( FCP ) and in the Social Cognitive Performance ( SCP ) of children with Autism Spectrum Disorders , based on two short periods of intervention .
METHODS	The study was conducted with 21 children with Autism Spectrum Disorder diagnoses , randomly allocated into two groups , who received the same short-term intervention types ( 6 weeks with the mother and 6 weeks with the support of an educational software program ) .
METHODS	The intervention process was conducted by speech-language pathologists who were part of a graduate program in this area .
RESULTS	Samples of 15-minute interaction sessions between the child and speech-language pathologist were used to assess the changes in the FCP and the SCP .
RESULTS	The statistic analysis pointed out differences only in Group 1 for the variables `` percentage of communicative space used '' and `` use of the mediating object '' .
CONCLUSIONS	With the intervention sessions structured over 12 weeks , it was possible to observe a few changes in the children 's FCP and in the SCP .
CONCLUSIONS	Therefore , we point out the need for new research studies of longer duration .

###24320728
BACKGROUND	Urticaria is a distressing condition associated with diverse clinical presentations .
BACKGROUND	Chronic spontaneous urticaria ( CsU ) is characterized by wheals and angioedema .
BACKGROUND	Its treatment requires an algorithmic approach to identify the optimum medication .
OBJECTIVE	Cetirizine is commonly used in the treatment of urticaria .
OBJECTIVE	Rupatadine is a selective non-sedating H1 - antihistamine approved for the treatment of CsU .
OBJECTIVE	This trial was conducted to ascertain whether the properties of rupatadine offer advantages over cetirizine .
METHODS	Seventy patients with CsU were enrolled .
METHODS	Parameters assessed included : ( i ) mean number of wheals ( MNW ) ; ( ii ) pruritus ; ( iii ) mean total symptom score ( MTSS ) ; ( iv ) size of wheal ; ( v ) interference of wheals with sleep ; and ( vi ) sedation .
METHODS	Patients with CsU were divided randomly into two groups .
METHODS	Routine investigations were performed at baseline and at the end of the study .
RESULTS	Evaluations of MTSS , MNW , and pruritus revealed statistically significant differences at week 3 compared with baseline in the cetirizine group .
RESULTS	However , greater reductions in these parameters were obtained with rupatadine .
RESULTS	In patients receiving rupatadine , reductions in the MNW , size of wheals , and intensity of erythema were also significant at six weeks ( P < 0.001 ) and were significantly greater than those in the cetirizine group ( P < 0.05 ) .
CONCLUSIONS	Improvements in MTSS , MNW , size of wheals , intensity of erythema , and differential eosinophil count imply that rupatadine is a particularly attractive therapeutic modality compared with cetirizine for the treatment of CsU .

###24459240
OBJECTIVE	This study evaluated the feasibility , acceptability , and initial efficacy of an intervention based on Schachter 's externality theory ; the Regulation of Cues ( ROC ) program .
METHODS	44 overweight and obese 8-12-year-old children and their parents were randomly assigned to a 4-month ROC program or the control group .
METHODS	Outcomes were assessed at baseline , posttreatment , and 4 months posttreatment and included acceptability and feasibility , body weight , and eating behaviors .
RESULTS	The ROC program had moderate to high acceptability ratings .
RESULTS	Significant improvements were found for the ROC group compared with the control group on child food responsiveness at posttreatment and eating in the absence of hunger at 4 months posttreatment .
RESULTS	Improvements were seen for the ROC group compared with the control group on body weight measures and food responsiveness , although these only approached significance .
CONCLUSIONS	The ROC intervention may be useful with overweight and obese children .
CONCLUSIONS	Larger , fully powered studies are needed to further evaluate the efficacy of this model .

###24386911
BACKGROUND	Although the use of bortezomib alone and in combination with steroids has shown efficacy in AL amyloidosis , its role in combination with high-dose melphalan and autologous stem cell transplantation ( HDM/SCT ) is unknown .
BACKGROUND	In this study , we evaluated bortezomib in combination with dexamethasone ( BD ) for induction chemotherapy prior to HDM/SCT .
METHODS	This was a single-center , prospective , randomized controlled trial comparing induction therapy consisting of two BD cycles followed by HDM/SCT ( BD+HDM / SCT ) with HDM/SCT alone in the treatment of patients with newly diagnosed AL amyloidosis .
METHODS	The hematological and organ responses of the patients were assessed every three months post HDM/SCT .
RESULTS	Fifty-six patients newly diagnosed with renal ( 100 % ) , cardiac ( 57.1 % ) , liver ( 7.1 % ) , or nervous system ( 8.9 % ) AL amyloidosis were enrolled in this study ; 28 patients were assigned to each arm .
RESULTS	Two patients died within 100days of HDM/SCT ( 3.6 % treatment-related mortality ) .
RESULTS	The overall hematologic response rates in the BD+HDM / SCT arm and HDM/SCT arm at three , six and twelve months were 78.5 % versus 50 % , 82.1 % versus 53.5 % and 85.7 % versus 53.5 % , respectively .
RESULTS	In the BD+HDM / SCT arm , 15 ( 53.5 % ) patients achieved a hematologic response after BD and before HDM/SCT .
RESULTS	An intention-to-treat analysis revealed a higher rate of complete remission in the BD+HDM / SCT arm at both 12 and 24months ( 67.9 % and 70 % , respectively ) than with the HDM/SCT-only therapy ( 35.7 % and 35 % , respectively , P = 0.03 ) .
RESULTS	After a median follow-up of 28months , the survival rates at 24months post-treatment start were 95.0 % in the BD+HDM / SCT group and 69.4 % in the HDM/SCT alone group ( P = 0.03 ) .
CONCLUSIONS	Our preliminary data suggest that the outcome of treating AL amyloidosis with BD induction and HDM/SCT was superior to the outcome of the HDM/SCT treatment alone .
BACKGROUND	This trial has been registered at clinicaltrials.gov with the number NCT01998503 .

###25873248
BACKGROUND	The prevalence of fibromyalgia increases worldwide and is characterized by widespread and chronic pain .
BACKGROUND	Treatment is difficult and includes both drug and non-drug approaches .
BACKGROUND	Milnacipran , an antidepressant , is used for fibromyalgia , with a possible beneficial effect on central pain modulation .
BACKGROUND	Our hypothesis is that the efficacy of milnacipran in fibromyalgia depends on the performance of pain inhibitory controls .
METHODS	A randomized , double blind , clinical trial ( NCT01747044 ) with two parallel groups , in 48 women with fibromyalgia , is planned in the Clinical Pharmacology Center , University Hospital , Clermont-Ferrand , France .
METHODS	Conditioned pain modulation ( estimated with thermal stimuli using a numeric pain rating scale ) , the primary endpoint measure , is evaluated before and one month after treatment with milnacipran or placebo .
METHODS	Secondary outcome measures include the predictability of pain descending pathways performance for milnacipran efficacy , tolerance and cognitive function .
METHODS	Data analysis is performed using mixed models ; the tests are two-sided , with a type I error set at alpha = 0.05 .
METHODS	Not only will this trial allow estimation of the beneficial effect of milnacipran on pain and on descending pain pathways but it will also evaluate whether the performance of this modulatory system could be predictive of its efficacy in alleviating pain .
CONCLUSIONS	This method would allow clinicians to take a pro-active attitude by performing a rapid psychophysical test before starting milnacipran treatment and would avoid unnecessary prescription while preventing therapeutic failure in patients who often face this recurrent problem .
BACKGROUND	ClinicalTrials.gov NCT01747044 .

###25427944
BACKGROUND	Opioid maintenance treatment is the option of choice to stabilize opioid-dependent patients .
BACKGROUND	Whilst efficacy of methadone and buprenorphine has been studied extensively , fewer data on slow-release oral morphine are available .
OBJECTIVE	This study analyzes the effects of slow-release oral morphine compared to methadone with regard to self-reported mental symptoms , drug use and satisfaction with treatment .
METHODS	The study was carried out as an open-label randomized crossover trial in 14 treatment sites in Switzerland and Germany .
METHODS	It comprised 2 crossover periods of 11 weeks each .
METHODS	For measuring mental symptoms , the Symptom Checklist-27 ( SCL-27 ) was used .
METHODS	Drug and alcohol use was assessed by the number of consumption days , and treatment satisfaction by a visual analogue scale .
RESULTS	A total of 157 patients were included for the analyses ( per-protocol sample ) .
RESULTS	Statistically significantly better outcomes for morphine as compared to methadone treatment were found for overall severity of mental symptoms ( SCL-27 Global Severity Index ) , as well as 5 of the 6 syndrome groups of the SCL-27 , and for treatment satisfaction .
RESULTS	There were no statistically significant differences with regard to drug or alcohol use between groups .
CONCLUSIONS	This study supports positive effects of slow-release oral morphine compared to methadone on patient-reported outcomes such as mental symptoms and treatment satisfaction with comparable effects on concomitant drug use .
CONCLUSIONS	Slow-release oral morphine represents a meaningful alternative to methadone for treatment of opioid dependence .

###25644619
OBJECTIVE	To document the anatomical effects of clear lens extraction by phacoemulsification versus trabeculectomy on anterior chamber angle in patients with primary angle-closure glaucoma ( PACG ) .
METHODS	Gonioscopy and ultrasound biomicroscopy ( UBM ) were performed pre-operatively , and at 1 year after clear lens extraction or trabeculectomy in PACG eyes .
RESULTS	Fifty PACG eyes of 50 patients were included .
RESULTS	Twenty-six eyes had clear lens extraction by phacoemulsification , while 24 eyes underwent trabeculectomy .
RESULTS	The mean extent of synechial angle closure was significantly reduced from 272.357.3 to 253.370.5 ( p = 0.007 ) by phacoemulsification , but it was only reduced from 285.064.6 to 283.155.5 ( p = 0.32 ) by trabeculectomy .
RESULTS	The mean angle-opening distance at 500 microns from sclera spur ( AOD500 ) measured by UBM was significantly increased from 220.393.8 microns to 388.9134.1 microns ( p < 0.001 ) by clear lens extraction , but decreased from 220.979.8 microns to 214.570.2 microns ( p = 0.11 ) by trabeculectomy .
RESULTS	The mean anterior chamber depth ( ACD ) measured by UBM was significantly increased from 1,983.8176.8 microns to 3335.0174.2 microns ( p < 0.001 ) by clear lens extraction , but decreased from 2,000.2214.5 microns to 1975.8218.2 microns ( p = 0.001 ) by trabeculectomy .
CONCLUSIONS	Compared to trabeculectomy , clear lens extraction resulted in a significant reduction in synechial angle closure , and an increase in anterior chamber angle width and anterior chamber depth in PACG eyes without cataract .

###24958908
BACKGROUND	Human immunodeficiency virus ( HIV ) - infected pregnant women are at increased risk of malaria and its complications .
BACKGROUND	In vitro and in vivo data suggest that the HIV protease inhibitors lopinavir/ritonavir may have potent antimalarial activity .
BACKGROUND	We sought to evaluate whether lopinavir/ritonavir-based antiretroviral therapy ( ART ) reduced the risk of placental malaria .
METHODS	HIV-infected , ART-naive pregnant women were enrolled between gestational weeks 12 and 28 and randomly assigned to receive lopinavir/ritonavir-based or efavirenz-based ART .
METHODS	Women received daily trimethoprim-sulfamethoxazole prophylaxis and insecticide-treated bed nets at enrollment and were followed up to 1 year after delivery .
METHODS	The primary outcome was placental malaria , defined by the detection of malaria parasites , using microscopy or polymerase chain reaction ( PCR ) analysis of placental blood specimens .
METHODS	Secondary outcomes included placental malaria , defined by histopathologic results ; adverse birth outcomes ; incidence of malaria ; and prevalence of asymptomatic parasitemia .
METHODS	Analyses were done using an intention-to-treat approach .
RESULTS	Of 389 subjects randomly assigned to a treatment group , 377 were followed through to delivery .
RESULTS	There was no significant difference in the risk of placental malaria , as defined by thick smear or PCR findings , between the lopinavir/ritonavir-based and efavirenz-based ART arms ( 7.4 % vs 9.8 % ; P = .45 ) .
RESULTS	Similarly , there were no differences in secondary outcomes between the 2 treatment arms .
CONCLUSIONS	Lopinavir/ritonavir-based ART did not reduce the risk of placental or maternal malaria or improve birth outcomes , compared with efavirenz-based ART .
BACKGROUND	NCT00993031 .

###24314359
BACKGROUND	TAK-085 is an omega-3 preparation that contains eicosapentaenoic acid ethyl-ester ( EPA-E ) and docosahexaenoic acid-ethyl ester used in the management of hypertriglyceridemia .
OBJECTIVE	The aim of the study was to evaluate the long-term safety ( adverse events [ AEs ] , laboratory parameters , vital signs , weight , and electrocardiograms ) and effects on lipid profiles , especially triglyceride levels , of TAK-085 in Japanese patients with hypertriglyceridemia ( triglyceride levels 150 mg/dL and < 750 mg/dL ) .
METHODS	In this multicenter , open-label , randomized study , adults with hypertriglyceridemia undergoing lifestyle modification received TAK-085 2 g ( 2 g once daily ; n = 165 ) or 4 g ( 2 g twice daily ; n = 171 ) , or EPA-E 1.8 g ( 0.6 g three times daily ; n = 167 ) for 52 weeks .
METHODS	Patients were stratified for co-administration of a statin .
RESULTS	TAK-085 was well tolerated throughout the 52-week study .
RESULTS	Overall , no substantial differences were found in the tolerability of TAK-085 2 g , TAK-085 4 g , and EPA-E 1.8 g with incidence rates for AEs of 83.6 % , 86.0 % , and 89.2 % , respectively .
RESULTS	Most AEs were mild or moderate in severity .
RESULTS	Triglyceride levels decreased from baseline in all groups by week 4 , and the decreases were maintained throughout the study .
RESULTS	At week 52 the reduction in triglycerides with TAK-085 2 g ( -13.9 % ) was similar to that with EPA-E 1.8 g ( -12.1 % ) , whereas the reduction seen with TAK-085 4 g ( -25.5 % ) was greater than that with EPA-E 1.8 g , as assessed by point estimates and 95 % confidence intervals .
CONCLUSIONS	TAK-085 was safe and well tolerated for up to 52 weeks of treatment in Japanese patients with hypertriglyceridemia undergoing lifestyle modification .
CONCLUSIONS	Reductions in triglyceride levels achieved after 4 weeks were maintained at 52 weeks .

###25682401
BACKGROUND	Various procedures have been used for the management of neglected and resistant clubfoot .
BACKGROUND	The aim of our study was to assess the clinical and radiological correction by Joshi 's external stabilization system ( JESS fixator ) and Simons subtalar release in resistant and neglected idiopathic congenital talipes equinovarus in children between the ages of 1 and 2 years .
METHODS	A total of 50 resistant and neglected clubfeet were randomly divided into two equal groups of 25 feet each .
METHODS	Group I was treated with JESS fixator and group II was treated with complete subtalar release as described by Simons .
METHODS	Assessment of correction achieved was done both clinically and radiologically .
METHODS	Functional outcome was assessed with Ponseti scale .
RESULTS	The change in clinical deformity and radiological correction of deformity were statistically significant within each group , but not significant when compared to each other .
RESULTS	In group I excellent results were obtained in 17 ( 68 % ) and good in 8 ( 32 % ) of the feet .
RESULTS	In group II , excellent results were found in 16 ( 64 % ) and good in 9 ( 36 % ) feet out of the 25 feet .
RESULTS	Pin-site infections were seen in two cases in group I and serious skin problems occurred in two feet in group II .
CONCLUSIONS	We conclude that there were no statistical significant differences between the outcomes of the two techniques in this short-term follow-up of 2.4 years .
CONCLUSIONS	Thus , functional distraction using JESS can be utilized as an alternative method in cases of neglected and resistant clubfoot .

###24573730
OBJECTIVE	Carbon dioxide ( CO2 ) insufflation during colonoscopy can significantly decrease abdominal pain and bloating after the procedure , but its impact on the frequency and duration of toilet use remains unknown .
OBJECTIVE	The aim of this study was to assess the impact of CO2 insufflation on toilet use after screening colonoscopy .
METHODS	From 138 average-risk individuals who underwent screening colonoscopy during March to August 2013 , 120 were enrolled and randomized to receive either CO2 or air insufflation at colonoscopy .
METHODS	Both the colonoscopist and participant were blinded to the type of gas used .
METHODS	Abdominal pain and distension were assessed using a visual analog scoring system .
METHODS	The frequency and duration of toilet visits during a 2-hour postcolonoscopy period were recorded using a radiofrequency identification system .
RESULTS	Baseline characteristics were similar in both groups in terms of age , sex , and procedure time .
RESULTS	In the 2 hours after colonoscopy , 50 participants ( 83 % ) in the air group and 18 participants ( 30 % ) in the CO2 group ( P < 0.001 ) used the toilet at least once .
RESULTS	The mean ( SD ) duration of each toilet visit was 5.934.65 minutes in the air group and 1.532.84 minutes in the CO2 group ( P < 0.001 ) .
RESULTS	The abdominal discomfort score was lower in the CO2 group than in the air group both at the end of the colonoscopy ( P < 0.001 ) and 2 hours later ( P < 0.001 ) .
CONCLUSIONS	Insufflation with CO2 can significantly reduce abdominal discomfort and toilet use after colonoscopy .
CONCLUSIONS	Use of this technique may help reduce patient burden and allow more efficient use of space in the endoscopy unit .

###25446600
BACKGROUND	Ginsenosides are the proposed bioactive constituent of ginseng , especially for the attenuation of postprandial glycemia ( PPG ) .
BACKGROUND	The efficacious proportion of total and specific ginsenosides , remains unknown .
BACKGROUND	Alcohol extraction of whole ginseng root can be used to selectively manipulate the ginsenoside profile with increasing alcohol concentrations producing high yields of total ginsenosides and varying their individual proportions .
OBJECTIVE	We aimed to compare the acute efficacy of different ethanol-extraction preparations of American ginseng ( AG ) and Korean red ginseng ( KRG ) , with their whole-root origins , on PPG and insulin parameters in healthy adults .
METHODS	Following an overnight fast , 13 healthy individuals ( Gender : 5M :8 F , with mean SD , age : 28.9 9.2 years , BMI : 26.3 2.7 kg/m ( 2 ) and fasting plasma glucose : 4.21 0.04 mmol/L ) randomly received 3g of each of the following 10 different ginseng treatments on separate visits : whole root KRG and AG ; 30 % , 50 % or 70 % ethanol extracts of KRG and AG and 2 cornstarch placebos .
METHODS	Treatments were consumed 40 min prior to a 50 g oral glucose challenge test with capillary blood samples collected at baseline , 15 , 30 , 45 , 60 , 90 and 120 min .
METHODS	Insulin samples were collected at 0 , 30 , 60 and 120 min .
RESULTS	There was no difference in attenuation of PPG among the tested ginseng preparations .
RESULTS	Measures of Insulin Sensitivity Index ( ISI ) showed increased insulin sensitivity ( IS ) with KRG-30 % and AG-50 % extracts compared to placebo ( p < 0.05 ) .
CONCLUSIONS	The insulin sensitizing effects of KRG-30 % and AG-50 % extracts suggest that other root parts , including other ginsenosides not typically measured , may influence PPG and insulin parameters .
CONCLUSIONS	There is potential for AG and KRG extracts to modulate IS , an independent predictor of type 2 diabetes .

###24552307
BACKGROUND	Bonafide psychotherapy is an effective treatment for generalised anxiety disorder compared to no-treatment .
BACKGROUND	Rather than creating increasing numbers of new overall treatment-packets within a medical meta-model , an additional approach to investigating clinical research designs may be to increase the understanding of already effective psychotherapies .
BACKGROUND	Treatment manuals and protocols allow a relatively high degree of freedom for the way therapists implement the overall treatment manuals .
BACKGROUND	There is a systematic lack of knowledge on how therapists should customise these overall protocols .
BACKGROUND	The present study experimentally examines three ways of conducting a bonafide psychotherapy based on a 15 session time-limited cognitive-behavioural therapy ( CBT ) protocol and their relation to the therapists ' protocol adherence and treatment efficacy .
METHODS	This trial will investigate three different methods of customising a bonafide CBT-protocol using dyadic peer-tutoring methodology ( primings ) .
METHODS	The individuals with GAD will be randomly assigned to one of three priming conditions ( resource priming , supportive resource priming , or adherence priming ) .
METHODS	The participant treatment allocation will be performed randomly .
METHODS	Therapists will be assigned to a peer-tutoring partner and priming condition based on a mutual agreement .
METHODS	Treatment outcomes will be assessed at the following times : observer based in-session outcomes , session-by-session post-session outcomes , treatment outcome at post assessment and treatment outcome at 6-month follow-up .
CONCLUSIONS	The proposed trial addresses the clinically relevant question of how to customise a bonafide psychotherapy protocol using tandem peer-tutoring methodology ( three priming conditions ) .
CONCLUSIONS	Through the development and testing of the proposed priming procedures , this study describes levels of adherence and how to conduct an overall treatment protocol in a more systematised way .
BACKGROUND	From ClinicalTrials.gov Identifier : NCT02039193 .

###24576156
BACKGROUND	De-escalating natalizumab ( NTZ ) to interferon beta 1b ( IFN B 1B ) is a possible treatment option in multiple sclerosis ( MS ) patients interrupting NTZ because of increased risk of progressive multifocal leukoencephalopathy ( PML ) .
BACKGROUND	The aim of this study was to evaluate satisfaction and adherence to treatment , behavioral and fatigue changes in patients switched to IFN B 1B compared to continued NTZ treatment .
METHODS	A 1 year , prospective , randomized , rater-blinded , parallel-group study .
METHODS	Nineteen relapsing remitting ( RR ) MS patients , randomly assigned to undergo either NTZ ( n = 10 ) or IFN B 1B ( n = 9 ) treatment , who had previously received NTZ for at least 12 months with disease stability and fearing or at risk for PML were included .
METHODS	Patients underwent behavioral and treatment assessments at baseline , after 24-week and 1 year follow-up .
METHODS	Behavioral assessment included measures of cognition , fatigue and quality of life .
METHODS	Treatment assessment included measures of satisfaction , persistence and adherence to treatment .
METHODS	Clinical-radiological disease activity and safety were also assessed .
RESULTS	Baseline characteristics of patients were similar between groups except for Euro Quality Visual Analogue Scale , being higher in the NTZ group ( p = 0.04 ) .
RESULTS	Within-group comparisons at the three time points , as well as interaction analysis of treatment effect over time did not show any statistically significant differences in behavioral or treatment assessments , but a coherent trend favoring NTZ over IFN B 1B .
CONCLUSIONS	De-escalating NTZ to IFN B 1B is feasible and associated with overall good patient related outcome and persistently stable behavioral measures .

###24567651
BACKGROUND	Three randomised controlled trials have provided strong evidence that Weight Watchers ( ) is an effective weight-loss programme but there is insufficient evidence to determine whether three other weight-loss programmes are also effective .
OBJECTIVE	To examine whether other group-based weight-loss programmes were not inferior to Weight Watchers .
METHODS	A prospective cohort study using a non-inferiority analysis of 3290 adults referred through primary care .
METHODS	METHOD Participants who met the eligibility criteria for primary care obesity management treatment chose a free programme ( Weight Watchers , Rosemary Conley Diet and Fitness Clubs , Slimming World or a NHS group programme ) lasting 3 months ; they were weighed at 3 months ( programme end ) and self-reported their weight at 12 months .
RESULTS	At 3 months , weight loss achieved through Rosemary Conley and Slimming World was not inferior to Weight Watchers .
RESULTS	The NHS group programme was inferior .
RESULTS	At 12 months Slimming World and Rosemary Conley were not inferior to Weight Watchers , although participants using Slimming World lost significantly more weight than those using Weight Watchers .
RESULTS	Data on the NHS group programme were inconclusive .
CONCLUSIONS	In the short term all commercial weight-loss programmes appear to result in similar weight loss but the NHS alternative appears to produce less weight loss .
CONCLUSIONS	At 12 months Slimming World led to greater weight loss but the differences between commercial programmes was small and of minor clinical importance .

###25414593
BACKGROUND	Our aim is to compare the hemodynamic effects of combined psoas compartment-sciatic nerve block ( PCSNB ) with continuous spinal anaesthesia ( CSA ) in elderly high-risk patients undergoing hip replacement surgery .
METHODS	Seventy patients over the age of 60 with ASA III or IV physical status were randomly allocated to two groups : In the PCSNB group , ultrasound-guided psoas compartment block was performed with modified Winnie technique using 30 mL of 0.25 % bupivacaine with 1:200.000 epinephrine ( 5 gr/mL ) and iliac crest block was performed using the same local anaesthetic solution ( 5 mL ) .
METHODS	All patients in the PCSNB group needed continuing infusion of propofol ( 2 mg/kg/h ) during operation .
METHODS	In the CSA group , CSA was performed in the L3-L4 interspaced with the patient in lateral decubitus position using 2.5 mg of isobaric bupivacaine 0.5 % .
METHODS	When sensory block was not reached to the level of T12 within 10 minutes in the CSA group , additional 2.5 mg of isobaric bupivacaine 0.5 % was administered through the catheter at 5-min intervals by limiting the total dose of 15 mg until a T12 level of the sensory block was achieved .
RESULTS	The PCSNB group had significantly higher mean arterial blood pressure values at the beginning of surgery and at 5 ( th ) , 10 ( th ) and 20 ( th ) minutes of surgery compared to the CSA group ( P = 0.038 , P = 0.029 , P = 0.012 , P = 0.009 respectively ) .
RESULTS	There were no significant differences between groups in terms of heart rate and peripheral oxygen saturation values during surgery and the postoperative period ( P > 0.05 ) .
RESULTS	Arterial hypotension required ephedrine was observed in 13 patients in the CSA and 4 patients in the PCSNB group ( P = 0.012 ) .
CONCLUSIONS	CSA and PCSNB produce satisfactory quality of anaesthesia in elderly high-risk patients with fewer hemodynamic changes in PCSNB cases compared with CSA cases .
BACKGROUND	Australian New Zealand Clinical Trials Registry : ACTRN12614000658617 , Registered 24 June 2014 .

###25142773
OBJECTIVE	Mandibular advancement splints ( MAS ) are often preferred to CPAP treatment for OSA but are not always equally efficacious .
OBJECTIVE	High therapeutic CPAP pressure has been associated with MAS treatment failure in a Japanese population .
OBJECTIVE	We sought to assess the relationship between CPAP pressure and MAS treatment response in an Australian population .
METHODS	Therapeutic CPAP pressure and MAS treatment response were obtained from a one-month crossover trial of both treatments .
METHODS	Predictive utility of CPAP pressure to identify MAS treatment response was assessed .
RESULTS	Seventy-eight OSA patients were included ( age 49.3 11.1 years , BMI 29.1 5.8 kg/m ( 2 ) ) with predominantly moderate-severe OSA ( AHI 30.0 12.7 / h ) .
RESULTS	CPAP pressure was lower in MAS responders ( MAS AHI < 10/h ) 9.7 1.6 vs. 11.7 2.4 cm H O , p < 0.01 , with area under ROC curve of 0.74 ( 95 % CI 0.63-0 .86 ) , p < 0.01 .
RESULTS	The best cutoff value of 10.5 cm H O useful for discriminating MAS responders and non-responders in the previous Japanese population , was inadequate for prediction in the current population ( 0.47 negative predictive value [ NPV ] ) .
RESULTS	However a cutoff of 13 cm H O identified MAS non-responders ( 1.0 NPV ) .
RESULTS	Multivariate regression identified CPAP pressure ( odds ratio [ 95 % confidence interval ] 0.53 [ 0.33-0 .87 ] , age ( 0.93 [ 0.87-0 .99 ] ) and AHI ( 0.92 [ 0.86-0 .97 ] ) as predictors of MAS treatment response ( model r ( 2 ) = 0.54 , p < 0.001 ) .
CONCLUSIONS	In Australian patients , the majority of whom are Caucasian , a higher therapeutic CPAP pressure requirement in conjunction with age and OSA severity characteristics may be useful to indicate likelihood of success with MAS as an alternative therapy .

###25015740
BACKGROUND	Since the results from the randomized TARGIT A trial were published , intraoperative radiotherapy ( IORT ) is used more often .
BACKGROUND	IORT can be provided as accelerated partial breast irradiation ( APBI ) or as a boost .
BACKGROUND	The definition of suitable patients for IORT as APBI differs between different national societies ( e.g. ESTRO and ASTRO ) and different inclusion criteria of trials and so does the eligibility of patients .
BACKGROUND	This analysis identifies eligible patients for IORT according to available consensus statements and inclusion criteria of the ongoing TARGIT trials .
METHODS	Between 01/03 - 12/09 , 1505 breast cancer cases were treated at the breast cancer center at the University Medical Center Mannheim .
METHODS	Complete data sets for age , stage ( T , N , and M ) , histology and hormone receptor status were available in 1108 cases .
METHODS	Parameters to identify eligible patients are as follows : ESTRO : > 50 years , invasive ductal carcinoma/other favorable histology ( IDC ) , T1-2 ( 3 cm ) , N0 , any hormone receptor status , M0 ; ASTRO : 60 years , IDC , T1 , N0 , positive estrogen hormone receptor status , M0 ; TARGIT E `` elderly '' , risk adapted radiotherapy with IORT followed by external beam radiotherapy in case of risk factors in final histopathology , phase II : 70 years , IDC , T1 , N0 , any hormone receptor status , M0 ; TARGIT C `` consolidation '' , risk adapted radiotherapy , phase IV : 50 years , IDC , T1 , N0 , positive hormone receptor status , M0 ; TARGIT BQR `` boost quality registry '' : every age , every histology , T1-2 ( max .
METHODS	3.5 cm ) , any hormone receptor status , N0 / + , M0 / + .
RESULTS	Out of the 1108 cases , 379 cases ( 34.2 % ) were suitable for IORT as APBI regarding the ESTRO and 175 ( 15.8 % ) regarding the ASTRO consensus statements .
RESULTS	82 ( 7.4 % ) patients were eligible for the TARGIT E trial , 258 ( 23.3 % ) for the TARGIT C trial and 671 ( 60.6 % ) for the TARGIT BQR registry .
RESULTS	According to the consensus statements of ASTRO ( 45.1 % ) and ESTRO ( 41.4 % ) about half of the eligible patients were treated with IORT as APBI .
RESULTS	From the eligible patients fulfilling the criteria for IORT boost ( 35 % ) about one third was eventually treated .
CONCLUSIONS	Patient selection for IORT should be restrictive .
CONCLUSIONS	For IORT as APBI the TARGIT trials are even more restrictive including patients than the ESTRO and ASTRO consensus statements .

###25722291
BACKGROUND	Cell-culture-derived ( CC ) influenza vaccine production methods could provide benefits over classical embryonated-egg technology , including a higher production capacity and the faster creation of a supply that meets demand .
METHODS	A CC-inactivated split-virus influenza A/Indonesia/5 / 2005 ( H5N1 ) vaccine derived from the EB66 cell line ( hereafter , `` CC-H5N1 '' ) was investigated in a phase 1 randomized , blinded study .
METHODS	Healthy adults ( n = 521 ) received 2 vaccine doses ( days 0 and 21 ) of either investigational CC-H5N1 vaccine ( 1.9 g or 3.75 g of hemagglutinin antigen [ HA ] with the AS03 adjuvant system or 15 g of plain HA ) , embryonated-egg-derived vaccines ( 3.75 g of HA with AS03 or 15 g of plain HA ) , or placebo .
METHODS	Assessment of the adjuvant effect and immunogenicity was performed using Center for Biologics Evaluation and Research acceptability criteria 21 days after dose 2 .
METHODS	Safety was assessed until month 12 .
RESULTS	AS03-adjuvanted CC-H5N1 elicited a homologous hemagglutination inhibition antibody response that satisfied immunogenicity criteria 21 days after dose 2 and persisted at month 12 .
RESULTS	Adjuvant effect and immune response against a drift-variant strain were demonstrated .
RESULTS	No vaccine-related serious adverse events were reported .
RESULTS	The immunogenicity and safety of the CC-H5N1 formulation containing 3.75 g of HA and AS03 appeared to be similar to those for the licensed egg-derived AS03-adjuvanted control vaccine .
CONCLUSIONS	The feasibility of the EB66 cell line to produce an immunogenic influenza vaccine with acceptable safety profile was demonstrated .
CONCLUSIONS	Antigen sparing was achieved through combination with AS03 adjuvant .
CONCLUSIONS	This CC-H5N1 might contribute to the rapid access of vaccine in the event of an influenza A ( H5N1 ) pandemic .
BACKGROUND	NCT01236040 .

###25654519
OBJECTIVE	The aim of this study was to evaluate a tailored physical activity protocol performed in a work environment with a group of female workers employed in manual precision tasks to reduce upper limb pain .
METHODS	Sixty female subjects were randomly assigned to an intervention group or a control group .
METHODS	The IG was administered of a 6-month , twice-a-week , tailored exercise program , whereas the CG received no intervention .
RESULTS	The IG showed a reduction on shoulder pain accompanied by increases on the range of motion measures .
RESULTS	In addition , reductions in upper limb pain and neck disability were detected with concomitant increases in grip strength .
CONCLUSIONS	This study indicated positive effects of a tailored workplace exercise protocol in female workers exposed to moderate risk for work-related musculoskeletal disorders , showing clinically meaningful reductions of pain symptoms and disability on upper limb and neck regions .

###24332432
BACKGROUND	Sayana Press ( SP ) , a subcutaneous formulation of depot medroxyprogesterone acetate ( DMPA ) prefilled in a Uniject injection system , could potentially improve and expand contraceptive injection services , but acceptability of SP is unknown .
BACKGROUND	HIV-positive women need contraception to avoid unintended pregnancy and risk of vertical HIV transmission .
BACKGROUND	We assessed acceptability of SP versus intramuscular DMPA ( DMPA-IM ) among HIV-positive women and their care providers in Rakai , Uganda .
METHODS	Women were randomized to DMPA-IM or SP at baseline , received the alternate product at 3 months , and chose their preferred method at 6 months .
METHODS	We determined preferences among new and experienced contraceptive injectable users who had tried both types of injection during the trial , and from providers before and after providing both types of injectables to clients .
RESULTS	Among 357 women randomized , 314 were followed up at 6 months ( 88 % ) .
RESULTS	Although SP caused more skin irritation than DMPA-IM ( 3.8 % vs. 0 % at 6 months , p = .03 ) , it was associated with marginally fewer side effects ( 30.4 % vs. 40.4 % at 6 months , p = .06 ) .
RESULTS	Participants reported high levels of willingness to recommend the DMPA contraception to a friend and satisfaction with the injection received , and these did not differ by injection type .
RESULTS	Sixty-four percent of women and 73 % of providers preferred SP to DMPA-IM at 6 months ; women 's preferences did not differ by previous experience with injectable contraception .
CONCLUSIONS	SP is acceptable to HIV-positive women and health care providers in this rural Ugandan population .
CONCLUSIONS	SP appears to be acceptable to HIV-positive women and their care providers in Rakai , Uganda , and strategies for appropriate rollout of this innovative technology should be explored .

###24504872
OBJECTIVE	The aim of this randomised clinical trial was to assess a comprehensive cardiac rehabilitation intervention including exercise training and psycho-education vs ` treatment as usual ' in patients treated with an implantable cardioverter defibrillator ( ICD ) .
METHODS	In this study 196 patients with first time ICD implantation ( mean age 57.2 ( standard deviation ( SD ) = 13.2 ) ; 79 % men ) were randomised ( 1:1 ) to comprehensive cardiac rehabilitation vs ` treatment as usual ' .
METHODS	Altogether 144 participants completed the 12 month follow-up .
METHODS	The intervention consisted of twelve weeks of exercise training and one year of psycho-educational follow-up focusing on modifiable factors associated with poor outcomes .
METHODS	Two primary outcomes , general health score ( Short Form-36 ( SF-36 ) ) and peak oxygen uptake ( VO ) , were used .
METHODS	Post-hoc analyses included SF-36 and ICD therapy history .
RESULTS	Comprehensive cardiac rehabilitation significantly increased VO2 uptake after exercise training to 23.0 ( 95 % confidence interval ( CI ) 20.9-22 .7 ) vs 20.8 ( 95 % CI 18.9-22 .7 ) ml/min/kg in the control group ( p = 0.004 ( multiplicity p = 0.015 ) ) .
RESULTS	Comprehensive cardiac rehabilitation significantly increased general health ; at three months ( mean 62.8 ( 95 % CI 58.1-67 .5 ) vs 64.4 ( 95 % CI : 59.6-69 .2 ) ) points ; at six months ( mean 66.7 ( 95 % CI 61.5-72 .0 ) vs 61.9 ( 95 % CI 56.1-67 .7 ) points ) ; and 12 months ( mean 63.5 ( 95 % CI 57.7-69 .3 ) vs 62.1 ( 95 % CI 56.2-68 .0 ) ) points ( p < 0.05 ) .
RESULTS	Explorative analyses showed a significant difference between groups in favour of the intervention group .
RESULTS	No significant difference was seen in ICD therapy history .
CONCLUSIONS	Comprehensive cardiac rehabilitation combining exercise training and a psycho-educational intervention improves VO-uptake and general health .
CONCLUSIONS	Furthermore , mental health seems improved .
CONCLUSIONS	No significant difference was found in the number of ICD shocks or anti-tachycardia pacing therapy .

###25453515
OBJECTIVE	The immune system has been implicated as one mechanism underlying the benefits of acupuncture therapy .
OBJECTIVE	Evidence suggests that acupuncture can ameliorate symptoms of chronic prostatitis/chronic pelvic pain syndrome ( CP/CPPS ) , but the association between clinical response and the immune system has not been investigated .
METHODS	We investigated 12 CP/CPPS patients participating in a prospective randomized clinical trial comparing acupuncture versus sham acupuncture for effects on cellular immunity .
METHODS	Blood samples were taken before the first needling and after the last of 20 treatment sessions ( week 10 ) .
METHODS	Patients also completed questionnaires examining their CP/CPPS symptoms and mood status at the baseline and end of study visits .
RESULTS	At the end of study 8 of 12 participants ( 67 % ) were classified as treatment responders , four participants each from the acupuncture and sham groups .
RESULTS	The acupuncture group averaged a 5 % increase in natural killer cell levels compared to corresponding sham ( -13 % ; p = 0.03 ) .
RESULTS	Similarly , patients randomized to acupuncture reported a reduction in other white blood cell parameters examined , supporting the possibility that immunity might be important in the pathophysiology of CP/CPPS .
CONCLUSIONS	The specific effect of acupuncture on CP/CPPS remains unclear .
CONCLUSIONS	Further research is warranted to examine the mechanisms by which acupuncture therapy may improve clinical symptoms in patients with CP/CPPS .
BACKGROUND	ClinicalTrials.gov number , NCT00260637 ) .

###25156854
BACKGROUND	Limited data is available on long-term atrial fibrillation ( AF ) free survival after multi-electrode catheter pulmonary vein isolation ( PVI ) .
BACKGROUND	The aim of this study was to compare point-by-point PVI to multi-electrode PVI in terms of procedural characteristics and long-term AF free survival .
RESULTS	460 consecutive patients were randomly allocated : 230 patients underwent conventional , point-by-point ablation with a radiofrequency ablation catheter ( cPVI group ) and 230 patients underwent multi-electrode , phased radiofrequency ablation ( MER group ) .
RESULTS	Median follow-up was 43 months .
RESULTS	Mean age was 56 years , 82 % of patients had paroxysmal AF .
RESULTS	Baseline characteristics did not differ among catheter groups .
RESULTS	Acute electrical PVI was achieved in 99.7 % of pulmonary veins , with no differences among catheter groups .
RESULTS	Procedure time and ablation time were significantly shorter in the MER group .
RESULTS	There were significantly less complications in the MER group ( 4.8 % vs. 1.3 % , P = 0.025 ) .
RESULTS	After a mean of 1.5 procedures , AF free survival without the use of antiarrhythmic drugs was 74 % at 1 year and 46 % at 5 years follow-up and did not differ among catheter groups ( cPVI group 45 % , MER group 48 % , P = 0.777 ) .
RESULTS	In multivariate analysis , BMI , AF duration and CHADSVASc score were predictors of AF free survival .
CONCLUSIONS	Multi-electrode ablation was superior in procedure duration and ablation time , with less complications .
CONCLUSIONS	However , both conventional point-by-point PVI and multi-electrode PVI achieved a high acute PVI success rate and showed a comparable long-term AF free survival .

###24958525
OBJECTIVE	To determine whether supplementation with the long-chain omega-3 polyunsaturated fatty acids eicosapentaenoic ( EPA ) and docosahexaenoic acid ( DHA ) affects behavioral symptoms and cognitive impairments in children 6-12 years of age diagnosed with attention-deficit/hyperactivity disorder ( ADHD ) .
METHODS	The randomized , double-blind placebo-controlled 16 weeks trial was conducted with 95 children diagnosed with ADHD according to DSM-IV criteria .
METHODS	Behavior was assessed by parents , teachers and investigators using standardized rating scales and questionnaires .
METHODS	Further outcome variables were working memory , speed of information processing and various measures of attention .
METHODS	For a subgroup of 81 participants , erythrocyte membrane fatty acid composition was analyzed before and after the intervention .
RESULTS	Supplementation with the omega-3 fatty acid mix increased EPA and DHA concentrations in erythrocyte membranes and improved working memory function , but had no effect on other cognitive measures and parent - and teacher-rated behavior in the study population .
RESULTS	Improved working memory correlated significantly with increased EPA , DHA and decreased AA ( arachidonic acid ) .

###25337035
BACKGROUND	Transfusion with red blood cells ( RBC ) may be needed during hip revision surgery but the appropriate haemoglobin concentration ( Hb ) threshold for transfusion has not been well established .
BACKGROUND	We hypothesized that a higher transfusion threshold would improve ambulation after hip revision surgery .
METHODS	The trial was registered at Clinicaltrials.gov ( NCT00906295 ) .
METHODS	Sixty-six patients aged 18 years or older undergoing hip revision surgery were randomized to receive RBC at a Hb threshold of either 7.3 g/dL ( restrictive group ) or 8.9 g/dL ( liberal group ) .
METHODS	Postoperative ambulation was assessed using Timed Up and Go-test ( TUG ) and ability to walk was also assessed daily by a physiotherapist blinded to the allocation .
RESULTS	Fifty-three patients were able to perform the TUG and included in the analysis .
RESULTS	The TUG could be completed in a median of 36 sec vs. 30 sec in the restrictive group and the liberal group , respectively ( P = 0.02 ) .
RESULTS	The mean difference in TUG was 14.5 sec ( 95 % CI 2.8-26 .2 sec ) .
RESULTS	No difference was found in the day patients could perform TUG or walk 10 meters .
RESULTS	The Hb at the day of testing was 10.2 g/dL in the restrictive group and 9.9 g/dL in the liberal group .
RESULTS	Only 26 patients received RBC .
CONCLUSIONS	A Hb transfusion threshold of 8.9 g/dL was associated with a statistically significantly faster TUG after hip revision surgery compared to a threshold of 7.3 g/dL but the clinical importance is questionable and the groups did not differ in Hb at the time of testing .

###25137188
BACKGROUND	Although acute treatments have been shown to be effective in treating early-onset depression , only one-third or thereabouts reach a remission within 3 months .
BACKGROUND	Unfortunately , delayed time to remission in early-onset depression leads to poorer therapeutic outcomes .
BACKGROUND	Clearly , there is a need to identify , diagnose , and provide effective treatment of a depressed patient quickly .
BACKGROUND	A sophisticated understanding of depression subscales and their change over time with treatment could enhance pathways to individualized treatment approaches for childhood depression .
OBJECTIVE	Previous studies have found that the clinician-measured instrument , Children 's Depression Rating Scale-Revised ( CDRS-R ) measures multiple subscales ( or components ) of depression .
OBJECTIVE	The aim of this study was to see how these subscales may change over the course of a 12-week study .
OBJECTIVE	This knowledge will help determine if dimensions/subscales of childhood depression ( paralleling the adult literature ) using the subscales derived from factor analysis procedure is useful .
METHODS	We examined two clinical trials in which youth ( n = 234 ) with major depressive disorder ( MDD ) were treated openly with fluoxetine for eight sessions spread over 12 weeks .
METHODS	The CDRS-R was completed based on clinician interviews with parent and child at each session .
METHODS	Classical test theory and component analysis with associated parallel analysis ( oblique rotation ) were conducted on each week 's scores .
RESULTS	Although more factors were needed for the baseline and first two therapy sessions , a two-factor solution sufficed thereafter .
RESULTS	Depressed facial affect , listless speech , and hypoactivity best defined Factor I , whereas sleep problems , appetite disturbance , physical symptoms , irritability , guilt , and weeping best defined Factor II .
RESULTS	All other symptoms cross-loaded almost equally on the two factors .
RESULTS	The scale 's reliability ( internal consistency ) improved from baseline to exit sessions ( = 0.65-0 .91 ) .
RESULTS	As a result , the clinicians ' assessments of the various symptoms became more highly related to one another .
RESULTS	This caused the first eigenvalue to increase from 3.24 to 7.38 and the variance explained to increase ( % ) from 19 % to 43 % over sessions .
RESULTS	These two factors may reflect 1 ) clinician-observed signs and 2 ) reported symptoms of depression .
CONCLUSIONS	Factor analysis of CDRS-R data in a single session consistently generates a complex and difficult to interpret structure of at least three factors .
CONCLUSIONS	This makes it very difficult to understand what these factors measure .
CONCLUSIONS	However , when gathered over additional sessions , the CDRS-R structure tends to simplify to two factors .
CONCLUSIONS	The reasons for this simplification are as yet unclear and in need of further study .

###24628390
OBJECTIVE	This study was conducted to determine the effects of folate supplementation on inflammatory factors and biomarkers of oxidative stress among women with polycystic ovary syndrome ( PCOS ) .
METHODS	This randomized , double-blind , placebo-controlled clinical trial was conducted among 69 women diagnosed with PCOS and aged 18-40year old .
METHODS	Participants were randomly assigned to three groups receiving the following : ( 1 ) folate-1 : 1mg/d folate supplements ( N = 23 ) ; ( 2 ) folate-5 : 5mg/d folate supplements ( N = 23 ) and ( 3 ) placebo ( N = 23 ) for 8weeks .
METHODS	Fasting blood samples were taken at the beginning of the study and after 8weeks to measure homocysteine ( Hcy ) , inflammatory factors including high-sensitivity C-reactive protein ( hs-CRP ) , nitric oxide ( NO ) , biomarkers of oxidative stress including total antioxidant capacity ( TAC ) , glutathione ( GSH ) , malondialdehyde ( MDA ) and homoeostatic model assessment-beta cell function ( HOMA-B ) .
RESULTS	Supplementation with 5mg/d folate resulted in reduced plasma Hcy ( -223 vs -186 and 116m , respectively , P < 005 ) , HOMA-B ( -763 vs 143 and 1366 , respectively , P < 005 ) , serum hs-CRP ( -2122 vs -2624 and 7298g/l , respectively , P < 005 ) and plasma MDA concentrations ( -048 vs -024 and 069m , respectively , P < 001 ) compared with folate-1 and placebo groups .
RESULTS	Furthermore , a significant rise in plasma TAC ( 064 vs -353 and -21547 mm , respectively , P < 001 ) and GSH levels ( 1621 vs 1958 and -1582 m , respectively , P < 001 ) was also observed following the administration of 5mg/d folate supplements compared with folate-1 and placebo groups .
CONCLUSIONS	In conclusion , folate supplementation ( 5mg/d ) in women with PCOS had beneficial effects on inflammatory factors and biomarkers of oxidative stress .

###24467258
OBJECTIVE	Teenage passengers affect teenage driving performance , possibly by social influence .
OBJECTIVE	To examine the effect of social norms on driving behavior , male teenagers were randomly assigned to drive in a simulator with a peer-aged confederate to whom participants were primed to attribute either risk-accepting or risk-averse social norms .
OBJECTIVE	It was hypothesized that teenage drivers would engage in more risky driving behavior in the presence of peer passengers than no passengers , and with a risk-accepting compared with a risk-averse passenger .
METHODS	66 male participants aged 16 to 18 years holding a provisional driver license were randomized to drive with a risk-accepting or risk-averse passenger in a simulator .
METHODS	Failure to Stop at a red light and percent Time in Red ( light ) were measured as primary risk-relevant outcomes of interest at 18 intersections , while driving once alone and once with their assigned passenger .
RESULTS	The effect of passenger presence on risky driving was moderated by passenger type for Failed to Stop in a generalized linear mixed model ( OR = 1.84 , 95 % CI [ 1.19 , 2.86 ] , p < .001 ) , and percent Time in Red in a mixed model ( B = 7.71 , 95 % CI [ 1.54 , 13.87 ] , p < .05 ) .
CONCLUSIONS	Exposure of teenage males to a risk-accepting confederate peer increased teenage males ' risky simulated driving behavior compared with exposure to a risk-averse confederate peer .
CONCLUSIONS	These results indicate that variability in teenage risky driving could be partially explained by social norms .

###24304363
BACKGROUND	Transcutaneous electrical tibial nerve stimulation ( TENS ) is of growing interest for the treatment of fecal incontinence ( FI ) , but its mechanism of action remains uninvestigated .
BACKGROUND	We aimed to further assess the anorectal response to TENS in a dynamic model .
METHODS	We performed a placebo-controlled , randomized , double-blinded crossover study in 19 patients suffering from FI to assess the effects of TENS on anorectal function .
METHODS	Anorectal physiology and perception were recorded through two sequences of rectal isobaric distension using an electronic barostat device to measure anal and rectal pressures , rectal volumes , and perception scores .
RESULTS	Maximal rectal pressure and volume variation were affected by TENS , with higher mean maximal rectal pressure ( 5.33 and 4.06 mmHg in the active and sham TENS respectively , p < 0.0001 ) and lower volume variation ( 11.45 and 14.7 mL in the active and sham stimulation respectively , p < 0.05 ) .
RESULTS	Rectal compliance was not modified by active TENS .
RESULTS	Pressure of the upper anal canal was significantly lower with raised isobaric distension in sequences assigned to active TENS .
CONCLUSIONS	Acute TENS modified anorectal physiology by strengthening the myogenic response to distension rather than increasing muscle relaxation and related rectal compliance in patients with FI .

###24807325
OBJECTIVE	To compare the incidence of wound complications between suture and staple skin closure after cesarean delivery .
METHODS	This prospective , randomized clinical trial conducted at three hospitals in the United States between 2010 and 2012 included women undergoing cesarean delivery at 23 weeks of gestation or greater through a low-transverse skin incision .
METHODS	Women were randomized to closure of the skin incision with suture or staples after stratifying by body mass index and primary compared with repeat cesarean delivery .
METHODS	The primary outcome was incidence of wound complications , predefined as a composite of infection , hematoma , seroma , separation of 1 cm or longer , or readmission for wound complications .
METHODS	Analysis was according to the intention-to-treat principle ; results were stratified by randomization group and adjusted for hospital by including it as a covariate .
RESULTS	A total of 746 women were randomized , 370 to suture and 376 to staple closure .
RESULTS	The median gestational age was 39 weeks .
RESULTS	Fifty-eight women ( 7.8 % ) had wound complications-4 .9 % in the suture group and 10.6 % in the staple group ( adjusted odds ratio [ OR ] 0.43 , 95 % confidence interval [ CI ] 0.23-0 .78 ) ; this was largely the result of the decreased incidence of wound separation in the respective groups ( 1.6 % compared with 7.4 % ; adjusted OR 0.20 , 95 % CI 0.07-0 .51 ) .
CONCLUSIONS	Suture closure of the skin incision at cesarean delivery is associated with a 57 % decrease in wound complications compared with staple closure .
BACKGROUND	Clinicaltrials.gov , www.clinicaltrials.gov , NCT01211600 .
METHODS	I.

###25611935
BACKGROUND	The purpose of this study was to compare physical activity ( PA ) outcomes in a sample of high school ( HS ) physical education ( PE ) lessons from schools that adopted traditional versus modified block schedule formats .
METHODS	We used the System for Observing Fitness Instruction Time ( SOFIT ) to conduct observations of 168 HS PE lessons delivered by 22 PE teachers in 4 schools .
METHODS	T-tests and multilevel models were used to explore variability in moderate PA and vigorous PA. .
RESULTS	PA outcomes were significantly different between modified block and traditional schools .
RESULTS	Students who attended traditional schools engaged in more vigorous PA in PE lessons .
RESULTS	Modified block lessons lost more scheduled lesson time due to poor transition to and from the locker room .
RESULTS	PA outcomes were positively associated with fitness and teacher promotion of PA and negatively associated with lost time , class size , management , and knowledge .
CONCLUSIONS	Although PE proponents widely advocate for more PE minutes , this study showed that greater time scheduled in PE does not necessarily result in more student accrual of moderate to vigorous physical activity ( MVPA ) minutes .

###24667090
OBJECTIVE	This study evaluated whether a nutrition-education program in child-care centers improved children 's at-home daily consumption of fruits and vegetables , at-home use of low-fat/fat-free milk , and other at-home dietary behaviors .
METHODS	Twenty-four child-care centers serving low-income families were matched by region , type , and size , and then randomly assigned to either an intervention or control condition .
METHODS	In the 12 intervention centers , registered dietitian nutritionists provided nutrition education to children and parents separately during a 6 - to 10-week period .
METHODS	They also held two training sessions for center staff , to educate them on healthy eating and physical activity policies at the centers , and distributed weekly parent newsletters that included activities and recipes .
METHODS	Parents ( n = 1,143 ) completed a mail or telephone survey at baseline and follow-up to report information on their child 's fruit , vegetable , and milk consumption and other dietary behaviors at home .
METHODS	This study used general and generalized linear mixed models to evaluate program impacts , while accounting for the clustering of children within centers .
METHODS	This study included child age , child sex , household size , respondent race/ethnicity , respondent age , and respondent sex as covariates .
RESULTS	The program had a substantial impact on children 's at-home daily consumption of vegetables and use of low-fat/fat-free milk .
RESULTS	This study also found a significant increase in the frequency of child-initiated vegetable snacking , which might have contributed to the significant increase in vegetable consumption .
RESULTS	The program did not have a significant impact on fruit consumption or parental offerings of fruits and vegetables , child-initiated fruit snacking , or child fruit consumption .
CONCLUSIONS	This intervention in child-care settings that emphasized children , parents , and teachers significantly increased at-home vegetable and low-fat/fat-free milk consumption among low-income preschoolers .

###24804220
OBJECTIVE	Greater skeletal muscle fat infiltration occurs with age and contributes to numerous negative health outcomes .
OBJECTIVE	The primary purpose was to determine whether intermuscular adipose tissue ( IMAT ) can be influenced by an exercise intervention and if a greater reduction in IMAT occurs with eccentric versus traditional resistance training .
METHODS	Seventy-seven older adults ( age 75.5 6.8 ) with multiple comorbidities and a history of falling completed a three-month exercise intervention paired with either eccentric or traditional resistance training .
METHODS	MRI of the mid-thigh was examined at three time points to determine changes in muscle composition after intervention .
RESULTS	No differences in IMAT were observed over time , and there were no differences in IMAT response between intervention groups .
RESULTS	Participants in the traditional group lost a significant amount of lean tissue ( P = 0.007 ) in the nine months after intervention , while participants in the eccentric group did not ( P = 0.32 ) .
RESULTS	When IMAT levels were partitioned into high and low IMAT groups , there were differential IMAT responses to intervention with the high group lowering thigh IMAT .
CONCLUSIONS	There is no decrease in thigh IMAT after a three-month exercise intervention in older adults at risk for falling and no benefit to eccentric training over traditional resistance training for reducing IMAT in these individuals .

###25518030
OBJECTIVE	Healing is an event that is fundamental to the success of total knee arthroplasty .
OBJECTIVE	The aims of the present study were to compare the rates of complications related to wound healing between two groups of volunteers submitted to total knee arthroplasty and to evaluate the effects of postoperative oxygen supplementation by means of a nasal catheter .
METHODS	A total of 109 patients who underwent total knee arthroplasty were randomized into two groups , namely , groups that did and did not receive postoperative oxygen supplementation via a nasal catheter .
METHODS	The surgical wound was monitored every day during the hospital stay and on the 7th , 14th , 21st , 30th and 42nd postoperative days .
METHODS	Characteristics related to healing were observed , including hyperemia , dehiscence , necrosis , phlyctenules and deep and superficial infection .
RESULTS	There were no cases of deep infection .
RESULTS	Hyperemia was statistically correlated with the total number of complications in the groups , with oxygen demonstrated to be a protective factor against hyperemia .
RESULTS	Approximately 30 % of the patients who exhibited hyperemia had other complications , independent of oxygen supplementation .
CONCLUSIONS	Oxygen supplementation following total knee arthroplasty was shown to be effective in diminishing hyperemia around the operative wound .
CONCLUSIONS	The development of hyperemia was a precursor to other complications , irrespective of whether oxygen supplementation was used .

###26521582
OBJECTIVE	To explore the clinical effect of Erlong Xizhu acupuncture for retinitis pigmentosa .
OBJECTIVE	Methods Sixty patients with retinitis pigmentosa were randomly divided into an Erlong Xizhu acupuncture group and a conventional acupuncture group , 30 cases in each one .
OBJECTIVE	In the conventional acupuncture group , Tongziliao ( GB 1 ) , Sizhukong ( TE 23 ) , Taiyang ( EX-HN 5 ) were acupunctured as the main acupoints by uniform reinforcing-reducing manipulation ; acupoints based on syndrome differentiation were coordinated by acupuncture manipulation of reinforcing deficiency and reducing excess .
OBJECTIVE	The treatment in the Erlong Xizhu acupuncture group was the same as that in the conventional group , except acupuncture manipulation at the main acupoints replaced by Erlong Xizhu acupuncture .
OBJECTIVE	In the two groups , treatment was given once a day , 10 days as one session and there were 2 days at the interval between sessions .
OBJECTIVE	The change of the vision and visual field and the efficacy were observed after 3 sessions in the two groups .
RESULTS	The total effective rate on enhancing the vision of patients in the Erlong Xizhu acupuncture group was 93.10 % ( 54/58 ) , which was superior to 81.36 % ( 48/59 ) in the conventional acupuncture group ( P < 0.01 ) .
RESULTS	And the effective rate on improving the visual field was 91.38 % ( 53/58 ) in the Erlong Xizhu acupuncture group , which was better than 83.05 % ( 49/59 ) in the conventional acupuncture group ( P < 0.01 ) .
RESULTS	On the comprehensive effect , the effective rate was 90.00 % ( 27/30 ) in the Erlong Xizhu acupuncture group , which was better than 63.34 % ( 19/30 ) in the conventional acupuncture group ( P < 0.05 ) .
CONCLUSIONS	The clinical effect of Erlong Xizhu acupuncture is superior to that of conventional acupuncture for retinitis pigmentosa and it is worthy of promoting .

###24299257
BACKGROUND	A significant number of individuals suffer from plantar heel pain ( PHP ) and many go on to have chronic symptoms and continued disability .
BACKGROUND	Persistence of symptoms adds to the economic burden of PHP and cost-effective solutions are needed .
BACKGROUND	Currently , there is a wide variation in treatment , cost , and outcomes of care for PHP with limited information on the cost-effectiveness and comparisons of common treatment approaches .
BACKGROUND	Two practice guidelines and recent evidence of effective physical therapy intervention are available to direct treatment but the timing and influence of physical therapy intervention in the multidisciplinary management of PHP is unclear .
BACKGROUND	The purpose of this investigation is to compare the outcomes and costs associated with early physical therapy intervention ( ePT ) following initial presentation to podiatry versus usual podiatric care ( uPOD ) in individuals with PHP .
METHODS	A parallel-group , block-randomized clinical trial will compare ePT and uPOD .
METHODS	Both groups will be seen initially by a podiatrist before allocation to a group that will receive physical therapy intervention consisting primarily of manual therapy , exercise , and modalities , or podiatric care consisting primarily of a stretching handout , medication , injections , and orthotics .
METHODS	Treatment in each group will be directed by practice guidelines and a procedural manual , yet the specific intervention for each participant will be selected by the treating provider .
METHODS	Between-group differences in the Foot and Ankle Ability Measure 6 months following the initial visit will be the primary outcome collected by an independent investigator .
METHODS	In addition , differences in the European Quality of Life -- Five Dimensions , Numeric Pain Rating Scale , Global Rating of Change ( GROC ) , health-related costs , and cost-effectiveness at 6 weeks , 6 months , and 1 year will be compared between groups .
METHODS	The association between successful outcomes based on GROC score and participant expectations of recovery generally , and specific to physical therapy and podiatry treatment , will also be analyzed .
CONCLUSIONS	This study will be the first pragmatic trial to investigate the clinical outcomes and cost-effectiveness of ePT and uPOD in individuals with PHP .
CONCLUSIONS	The results will serve to inform clinical practice decisions and management guidelines of multiple disciplines .
BACKGROUND	ClinicalTrials.gov : NCT01865734 .

###25175734
OBJECTIVE	To evaluate the efficacy and safety of canagliflozin , a sodium glucose co-transporter 2 inhibitor , in Asian patients with type 2 diabetes mellitus ( T2DM ) inadequately controlled by metformin or metformin in combination with sulphonylurea .
METHODS	In this 18-week , randomized , double-blind , placebo-controlled phase III study , patients ( N = 676 ) received canagliflozin 100 or 300mg or placebo once daily .
METHODS	The primary efficacy endpoint was change in glycated haemoglobin ( HbA1c ) level from baseline at week 18 .
METHODS	Additional endpoints included change in fasting plasma glucose ( FPG ) and percent change in body weight .
METHODS	Adverse events ( AEs ) were recorded throughout the study .
METHODS	Efficacy and safety were assessed in the overall population and in two strata based on background therapy .
RESULTS	At week 18 , canagliflozin 100 and 300mg provided significant reductions from baseline in HbA1c compared with placebo ( -0.97 , -1.06 and -0.47 % , respectively ; p < 0.001 ) .
RESULTS	Relative to placebo , canagliflozin 100 and 300mg also significantly reduced FPG ( -1.0 and -1.4 mmol/l ) and body weight [ -2.2 % ( -1.5 kg ) and -2.3 % ( -1.6 kg ) ] .
RESULTS	Both canagliflozin doses lowered systolic blood pressure ( BP ) compared with placebo .
RESULTS	The overall incidence of AEs was 38.6 , 43.2 and 42.0 % with canagliflozin 100 and 300mg and placebo , respectively .
RESULTS	The incidence of genital mycotic infections and urinary tract infections was low and similar across groups .
RESULTS	Efficacy and safety findings in the two strata were generally consistent with the overall population .
CONCLUSIONS	Canagliflozin provided glycaemic improvements and reductions in body weight and systolic BP , and was generally well tolerated in Asian patients with T2DM on metformin or metformin in combination with sulphonylurea .

###24528693
BACKGROUND	Fish oil intake reduces serum triglycerides ; however , little is known about the effects of dietary fish intake on lipoprotein subclasses .
OBJECTIVE	We aimed at assessing the effect of fatty and lean fish intake on the lipoprotein subclasses in an intervention study .
METHODS	The intervention study included 33 patients with coronary heart disease , who were aged 61.0 5.8 ( mean SD ) years .
METHODS	The subjects were randomly assigned to a fatty fish ( n = 11 ) , lean fish ( n = 12 ) , or control ( n = 10 ) diet for 8 weeks .
METHODS	Fish diets included at least 4 fish meals per week .
METHODS	Subjects in the control group consumed lean beef , pork , and chicken .
METHODS	Lipoprotein subclasses and their lipid components were determined by nuclear magnetic resonance spectroscopy .
RESULTS	Concentrations of n-3 fatty acids and docosahexaenoic acid increased in the fatty fish group .
RESULTS	The concentrations of cholesterol , cholesterol esters , and total lipids in very large high-density lipoproteins ( HDLs ) increased in the fatty fish group ( overall difference P = .005 , P = .002 , and P = .007 , respectively ; false discovery rate P = .04 , P = .04 , and P = .05 , respectively ) .
RESULTS	The mean size of HDL particles increased in the fatty fish group ( 9.8 0.3 nm at baseline and 9.9 0.4 nm at end of study ; overall difference P = .004 , false discovery rate P = .04 ) .
RESULTS	The fish diets did not affect very-low-density lipoprotein or low-density lipoprotein size .
CONCLUSIONS	Fatty fish intake at least 4 times per week increases HDL particle size which might have beneficial effect in patients with coronary heart disease .

###24618485
OBJECTIVE	The purpose of our study is to present a surgical technique of primary porous orbital ball implantation with overlying mucus membrane graft ( MMG ) for reconstruction of severely contracted socket and to evaluate prosthesis retention and motility in comparison to dermis fat graft ( DFG ) .
METHODS	Prospective comparative study .
METHODS	A total of 24 patients of severe socket contracture ( Grade 2-4 Krishna 's classification ) were subdivided into two groups , 12 patients in each group .
METHODS	In Group I , DFG have been used for reconstruction .
METHODS	In Group II , porous polyethylene implant with MMG has been used as a primary procedure for socket reconstruction .
METHODS	In Group I DFG was carried out in usual procedure .
METHODS	In case of Group II , vascularized scar tissues were separated 360 and were fashioned into four strips .
METHODS	A scleral capped porous polyethylene implant was placed in the intraconal space and four strips of scar tissue were secured to the scleral cap and extended part overlapped the implant to make a twofold barrier between the implant and MMG .
METHODS	Patients were followed-up as per prefixed proforma .
METHODS	Prosthesis motility and retention between the two groups were measured .
RESULTS	In Group I , four patients had recurrence of contracture with fall out of prosthesis .
RESULTS	In Group II stable reconstruction was achieved in all the patients .
RESULTS	In terms of prosthesis motility , maximum in Group I was 39.2 % and Group II , was 59.3 % .
RESULTS	The difference in prosthesis retention ( P = 0.001 ) and motility ( P = 0.004 ) between the two groups was significant .
CONCLUSIONS	Primary socket reconstruction with porous orbital implant and MMG for severe socket contracture is an effective method in terms of prosthesis motility and prosthesis retention .

###25860108
BACKGROUND	Female adolescents at high pregnancy risk frequently visit the emergency department ( ED ) and lack primary providers .
BACKGROUND	It is unclear if current methods of ED referral are successful .
BACKGROUND	The objective of this pilot study was to assess the potential effect and feasibility of a standardized , enhanced method of referral of sexually active females from an ED for family planning ( FP ) .
METHODS	We conducted an ED-based intervention study using an enhanced referral process , which included a wallet card advertising a walk-in , adolescent-friendly FP clinic and a standardized ED physician monologue .
METHODS	ED physicians were instructed to disseminate the enhanced process to sexually active females ages 12-19 years ( intervention group ) .
METHODS	Patients receiving the intervention were prospectively enrolled .
METHODS	The control group consisted of patients who , on retrospective review , came to the ED during the enrollment period and were eligible but were not enrolled .
METHODS	We used the electronic medical record ( EMR ) to identify and randomly select missed eligible patients ( control group ) and accumulated one control for each case .
METHODS	The primary outcome was FP follow-up within 2 months , measured by EMR review .
RESULTS	The intervention ( n = 101 ) and control groups ( n = 101 ) were similar in age , prior ED visits ( 54 % versus 56 % ) , and previous FP visits ( 28 % versus 28 % ) .
RESULTS	The absolute difference in follow-up to a FP clinic between the enhanced referral group ( 7 % ; 7/101 ) compared with the nonenhanced referral group ( 5 % ; 5/101 ) was only 2 % ( 95 % confidence interval -5 % to 9 % ) .
RESULTS	Feasibility of the intervention was modest , with a best-case scenario of 59/160 ( 37 % ) of eligible patients captured .
CONCLUSIONS	An enhanced referral initiative relying on physician participation did not substantially increase follow-up rates to a FP clinic and showed modest feasibility .
CONCLUSIONS	More research is required to identify effective means of ED-based referral for preventive reproductive care .

###24328444
BACKGROUND	Commonly used trivalent vaccines contain one influenza B virus lineage and may be ineffective against viruses of the other B lineage .
BACKGROUND	We evaluated the efficacy of a candidate inactivated quadrivalent influenza vaccine ( QIV ) containing both B lineages .
METHODS	In this multinational , phase 3 , observer-blinded study , we randomly assigned children 3 to 8 years of age , in a 1:1 ratio , to receive the QIV or a hepatitis A vaccine ( control ) .
METHODS	The primary end point was influenza A or B confirmed by real-time polymerase chain reaction ( rt-PCR ) .
METHODS	Secondary end points were rt-PCR-confirmed , moderate-to-severe influenza and rt-PCR-positive , culture-confirmed influenza .
METHODS	The vaccine efficacy and the effect of vaccination on daily activities and utilization of health care resources were assessed in the total vaccinated cohort ( 2584 children in each group ) and the per-protocol cohort ( 2379 children in the QIV group and 2398 in the control group ) .
RESULTS	In the total vaccinated cohort , 62 children in the QIV group ( 2.40 % ) and 148 in the control group ( 5.73 % ) had rt-PCR-confirmed influenza , representing a QIV efficacy of 59.3 % ( 95 % confidence interval [ CI ] , 45.2 to 69.7 ) , with efficacy against culture-confirmed influenza of 59.1 % ( 97.5 % CI , 41.2 to 71.5 ) .
RESULTS	For moderate-to-severe rt-PCR-confirmed influenza , the attack rate was 0.62 % ( 16 cases ) in the QIV group and 2.36 % ( 61 cases ) in the control group , representing a QIV efficacy of 74.2 % ( 97.5 % CI , 51.5 to 86.2 ) .
RESULTS	In the per-protocol cohort , the QIV efficacy was 55.4 % ( 95 % CI , 39.1 to 67.3 ) , and the efficacy against culture-confirmed influenza 55.9 % ( 97.5 % CI , 35.4 to 69.9 ) ; the efficacy among children with moderate-to-severe influenza was 73.1 % ( 97.5 % CI , 47.1 to 86.3 ) .
RESULTS	The QIV was associated with reduced risks of a body temperature above 39C and lower respiratory tract illness , as compared with the control vaccine , in the per-protocol cohort ( relative risk , 0.29 [ 95 % CI , 0.16 to 0.56 ] and 0.20 [ 95 % CI , 0.04 to 0.92 ] , respectively ) .
RESULTS	The QIV was immunogenic against all four strains .
RESULTS	Serious adverse events occurred in 36 children in the QIV group ( 1.4 % ) and in 24 children in the control group ( 0.9 % ) .
CONCLUSIONS	The QIV was efficacious in preventing influenza in children .
CONCLUSIONS	( Funded by GlaxoSmithKline Biologicals ; ClinicalTrials.gov number , NCT01218308 . )

###24984130
OBJECTIVE	To compare the analgesic effects of buprenorphine and butorphanol in domestic cats .
METHODS	2-phase positive-controlled randomized masked clinical trial .
METHODS	39 healthy female cats ( 10 in phase 1 and 29 in phase 2 ) .
METHODS	Cats admitted for ovariohysterectomy received buprenorphine ( 4 in phase 1 ; 14 in phase 2 ) or butorphanol ( 6 in phase 1 ; 15 in phase 2 ) .
METHODS	In phase 1 , cats were premedicated with buprenorphine ( 0.02 mg/kg [ 0.009 mg/lb ] , IM ) or butorphanol ( 0.4 mg/kg [ 0.18 mg/lb ] , IM ) , in combination with medetomidine .
METHODS	Anesthesia was induced with propofol ( IV ) and maintained with isoflurane in oxygen .
METHODS	After extubation , medetomidine was antagonized with atipamezole .
METHODS	A validated multidimensional composite scale was used to assess signs of pain after surgery starting 20 minutes after extubation and continuing for up to 360 minutes , and pain score comparisons were made between the 2 groups .
METHODS	Phase 2 proceeded similar to phase 1 with the following addition : during wound closure , cats from the butorphanol and buprenorphine groups received butorphanol ( 0.4 mg/kg , IM ) or buprenorphine ( 0.02 mg/kg , IM ) , respectively .
RESULTS	Phase 1 of the study was stopped after 10 cats were ovariohysterectomized because 9 of 10 cats required rescue analgesia at the first evaluation .
RESULTS	In phase 2 , at the first pain evaluation , pain scores from the buprenorphine group were lower , and all cats from the butorphanol group required rescue analgesia .
RESULTS	None of the cats from the buprenorphine group required rescue analgesia at any time .
CONCLUSIONS	Buprenorphine ( 0.02 mg/kg , IM ) given before surgery and during wound closure provided adequate analgesia for 6 hours following ovariohysterectomy in cats , whereas butorphanol did not .

###24340417
BACKGROUND	Family-centered rounds ( FCR ) are becoming the status quo for inpatient pediatric medical care ; however , barriers still exist .
BACKGROUND	The use of facilitators in FCR is gaining popularity .
BACKGROUND	Although facilitators can increase comfort with FCR , the choice of preferred facilitator has not been studied by using rigorous methodology .
BACKGROUND	In this study , we performed a randomized trial of facilitated FCR with bunnies and clowns , 2 commonly mentioned facilitators , and compared their results with the usual care condition .
METHODS	The 3 floor teams were randomized to have rounds facilitated with bunnies and clowns or the usual care model facilitated by distracted residents and overbearing attending physicians .
METHODS	Infection control procedures were instituted .
METHODS	Outcome measures were parent satisfaction scores , use of anxiolytic agents during examinations as part of FCR , resident satisfaction , and the number of times presenters were interrupted by their attending .
METHODS	Differences between the experimental and control groups were analyzed by using ttests , chi2 statistics , and multiple regression analysis .
METHODS	Qualitative analyses were also performed by using participant-observers .
RESULTS	Bunnies had the best overall improvement in parent satisfaction , anxiety , and resident satisfaction .
RESULTS	Both intervention groups were successful at reducing attending interruptions .
RESULTS	The clown arm was suspended by the Data Safety Monitoring Board before study completion due to adverse events .
CONCLUSIONS	Facilitated FCR has the potential to improve satisfaction among parents , patients , and residents , and to decrease attending interruptions .
CONCLUSIONS	Care needs to be taken , however , to avoid unanticipated adverse effects from potentially emotionally damaging interventions .
CONCLUSIONS	Tularemia was not identified in any of our treatment conditions .

###24954053
OBJECTIVE	This study assessed oral health status for preschool-aged children in the Navajo Nation to obtain data on baseline decayed , missing , and filled tooth surfaces ( dmfs ) and dental caries patterns , describe sociodemographic correlates of children 's baseline dmfs measures , and compare the children 's dmfs measures with previous dental survey data for the Navajo Nation from the Indian Health Service and the National Health and Nutrition Examination Survey ( NHANES ) .
METHODS	The analyzed study sample included 981 child/caregiver dyads residing in the Navajo Nation who completed baseline dmfs assessments for an ongoing randomized clinical trial involving Navajo Nation Head Start Centers .
METHODS	Calibrated dental hygienists collected baseline dmfs data from child participants ages 3-5 years ( 488 males and 493 females ) , and caregivers completed a basic research factors questionnaire .
RESULTS	Mean dmfs for the study population was 21.33 ( SD = 19.99 ) and not appreciably different from the 1999 Indian Health Service survey of Navajo Nation preschool-aged children ( mean = 19.02 , SD = 16.59 , P = 0.08 ) .
RESULTS	However , only 69.5 percent of children in the current study had untreated decay compared with 82.9 percent in the 1999 Indian Health Service survey ( P < 0.0001 ) .
RESULTS	Study results were considerably higher than the 16.0 percent reported for 2-4-year-old children in the whites-only group from the 1999-2004 NHANES data .
RESULTS	Age had the strongest association with dmfs , followed by child gender , then caregiver income and education .
CONCLUSIONS	Dental caries in preschool-aged Navajo children is extremely high compared with other US population segments , and dmfs has not appreciably changed for more than a decade .

###25223209
OBJECTIVE	To compare the post cataract surgery anti-inflammatory effect of bromfenac monotherapy and of bromfenac and betamethasone combination therapy in diabetes mellitus patients .
METHODS	A prospective study approved by the Institutional Review Board .
METHODS	Fifty-one eyes of 51 patients were randomly allocated to either bromfenac 0.1 % monotherapy ( n = 23 ) or combined therapy with bromfenac 0.1 % and betamethasone 0.1 % ( n = 28 ) .
METHODS	After surgery , monotherapy group was administered bromfenac alone for 8 weeks , while the combined therapy group was administered both bromfenac and betamethasone for 2 weeks , bromfenac alone for the next 6 weeks .
METHODS	The amount of change from preoperative values in anterior chamber flare and foveal thickness were compared between the 2 groups .
RESULTS	There was no significant difference in change in anterior chamber flare between the 2 groups .
RESULTS	The increase in foveal thickness 4 weeks postoperatively was significantly larger in the bromfenac group ( p = 0.0356 ) .
RESULTS	Four patients of the bromfenac group , all with a history of diabetic macular edema , developed macular edema after surgery .
CONCLUSIONS	Bromfenac and betamethasone combination exhibited a stronger anti-inflammatory effect after cataract surgery patients with diabetes mellitus .
CONCLUSIONS	In particular , patients with a history of diabetic macular edema were susceptible to foveal thickening and macular edema , and a combined treatment is desirable .

###25241220
BACKGROUND	The role of implantable loop recorders ( ILRs ) in the evaluation strategy for recurrent syncope in France is limited by lack of knowledge of the cost .
OBJECTIVE	To compare a conventional evaluation strategy for syncope with the early use of an ILR in low-risk patients , in terms of diagnostic yield , cost and impact on quality of life ( QoL ) .
METHODS	National prospective randomized open-label multicenter study of patients with a single syncope ( if severe and recent ) or at least two syncopes in the past year .
RESULTS	Seventy-eight patients ( 32 men ) were randomized to the ILR strategy ( ILR group , n = 39 ) or the conventional evaluation strategy ( CONV group , n = 39 ) : mean age 66.214.8 years ; 4.36.4 previous syncopes .
RESULTS	After 14 months of follow-up , a certain cause of syncope was established in 18 ( 46.2 % ) patients in the ILR group and two ( 5 % ) patients in the CONV group ( P < 0.001 ) .
RESULTS	Advanced cardiological tests were performed less frequently in the ILR group than in the CONV group ( 0.030.2 vs. 0.20.5 tests per patient ; P = 0.05 ) .
RESULTS	Patients in the ILR group were hospitalized for a non-significantly shorter period than patients in the CONV group ( 5.73.2 vs. 8.01.4 days ) .
RESULTS	There was no difference between the two groups in terms of QoL main composite score .
CONCLUSIONS	In patients with unexplained syncope , the early use of an ILR has a superior diagnostic yield compared with the conventional evaluation strategy , with lower healthcare-related costs .

###24824648
OBJECTIVE	More severe influenza disease and poor vaccine immunogenicity is reported in HIV-infected patients .
OBJECTIVE	We measured antibody avidity after influenza vaccination in HIV patients to assess vaccine efficacy .
METHODS	Two dosing strategies ( Group1 : single dose , n = 28 .
METHODS	Group2 : single dose plus booster , n = 36 ) with an AS03A-adjuvanted H1N12009 pandemic influenza vaccine ( Arepanrix , GSK ) were assessed in HIV patients .
METHODS	Serum hemagglutination inhibition ( HAI ) titers and antibody avidity reported as an avidity index ( AI ) were measured at days 21 and 42 and at 6months .
RESULTS	Baseline HIV parameters were similar among all participants .
RESULTS	Eighteen participants had measurable baseline HAI titers .
RESULTS	In these subjects , AI was at ~ 9 at baseline and was not significantly increased by one or two vaccine doses .
RESULTS	In those without detectable baseline antibodies , immunization induced modest antibody titers [ Group1 HAI , 61 ( 26-144 ) ; Group2 HAI , 46 ( 28-76 ) ] with high AI after one dose at day 21 [ Group1 AI , 8.8 ( 7.3-10 .7 ) ; Group2 AI , 8.9 ( 7.8-10 .1 ) ] .
RESULTS	A second dose of vaccine generated significantly higher HAI titers at day 42 [ Group1 HAI , 41 ( 18-90 ) ; Group2 HAI , 92 ( 64-132 ) ] and persisted to 6months [ Group1 HAI , 9 ( 6-13 ) ; Group2 HAI , 19 ( 13-30 ) ] .
RESULTS	All subjects who produced detectable HAI titers after vaccination generated high antibody avidity ( AI , 9-10 ) , which persisted up to 6months .
CONCLUSIONS	In participants initially seronegative , two doses of vaccine enabled a greater percentage of subjects to respond to the vaccine and elicited higher HAI titers .
CONCLUSIONS	All subjects who produced detectable HAI titers also rapidly generated high AI in the short and long term .
CONCLUSIONS	We demonstrate that high avidity antibodies can be achieved after vaccination and support a two-dose immunization strategy for HIV-positive subjects .

###25535650
OBJECTIVE	The present paper aims to investigate the effect of psoriatic arthritis ( PsA ) disease duration on the outcome of treatment with etanercept ( ETN ) in patients with PsA who also have moderate-to-severe psoriasis .
METHODS	Patients from the PRESTA trial who received 1 ETN 50 mg once weekly ( QW ) dose and had 1 post-baseline value were evaluated .
METHODS	Baseline and after-treatment changes were compared between patients with PsA 2 years versus PsA > 2 years in efficacy measures ( physician global assessment [ PGA ] arthritis , swollen joint count and Psoriasis Area and Severity Index [ PASI ] ) and patient reported outcomes ( PROs ; joint pain , arthritis activity , Euro-Qol [ EQ-5D ] utility and visual analogue score [ VAS ] ) using linear regression analysis .
RESULTS	Baseline efficacy measures were similar between the PsA 2 years ( n = 103 ) and PsA > 2 years ( n = 269 ) groups , with the exception of PGA arthritis ( p = 0.006 ) .
RESULTS	At week 24 , improvements in efficacy measures were observed in both groups but were significantly greater for PGA arthritis in the PsA 2 years group ( p = 0.03 ) .
RESULTS	Quality of life ( QoL ) , measured using PROs , was generally lower at baseline in patients with PsA > 2 years .
RESULTS	Clinically meaningful improvements were seen in QoL with ETN treatment in both groups , but the change from baseline scores at week 24 were significantly higher in PsA 2 years group for joint pain ( p = 0.007 ) , arthritis activity ( p = 0.01 ) , EQ-5D utility ( p = 0.046 ) and EQ-5D VAS ( p = 0.04 ) responses .
CONCLUSIONS	PsA patients responded to ETN 50 mg QW treatment irrespective of disease duration ; however , patients with shorter PsA duration had greater improvements in arthritis scores and several PRO measures .

###24890224
OBJECTIVE	To compare anaesthetic induction in healthy dogs using propofol or ketofol ( a propofol-ketamine mixture ) .
METHODS	Prospective , randomized , controlled , ` blinded ' study .
METHODS	Seventy healthy dogs ( 33 males and 37 females ) , aged 6-157 months and weighing 4-48 kg .
METHODS	Following premedication , either propofol ( 10 mg mL ( -1 ) ) or ketofol ( 9 mg propofol and 9 mg ketamine mL ( -1 ) ) was titrated intravenously until laryngoscopy and tracheal intubation were possible .
METHODS	Pulse rate ( PR ) , respiratory rate ( f ( R ) ) and arterial blood pressure ( ABP ) were compared to post-premedication values and time to first breath ( TTFB ) recorded .
METHODS	Sedation quality , tracheal intubation and anaesthetic induction were scored by an observer who was unaware of treatment group .
METHODS	Mann-Whitney or t-tests were performed and significance set at p 0.05 .
RESULTS	Induction mixture volume ( mean SD ) was lower for ketofol ( 0.2 0.1 mL kg ( -1 ) ) than propofol ( 0.4 0.1 mL kg ( -1 ) ) ( p < 0.001 ) .
RESULTS	PR increased following ketofol ( by 35 20 beats minute ( -1 ) ) but not consistently following propofol ( 4 16 beats minute ( -1 ) ) ( p < 0.001 ) .
RESULTS	Ketofol administration was associated with a higher mean arterial blood pressure ( MAP ) ( 82 10 mmHg ) than propofol ( 77 11 ) ( p = 0.05 ) .
RESULTS	TTFB was similar , but ketofol use resulted in a greater decrease in f ( R ) ( median ( range ) : ketofol -32 ( -158 to 0 ) propofol -24 ( -187 to 2 ) breaths minute ( -1 ) ) ( p < 0.001 ) .
RESULTS	Sedation was similar between groups .
RESULTS	Tracheal intubation and induction qualities were better with ketofol than propofol ( p = 0.04 and 0.02 respectively ) .
CONCLUSIONS	Induction of anaesthesia with ketofol resulted in higher PR and MAP than when propofol was used , but lower f ( R ) .
CONCLUSIONS	Quality of induction and tracheal intubation were consistently good with ketofol , but more variable when using propofol .

###25362223
BACKGROUND	Unfractionated ( UF ) heparin is the most common anticoagulant used during hemodialysis .
BACKGROUND	Failure of the kidneys to excrete potassium as well as heparin-induced reduction of aldosterone synthesis put hemodialysis patients at risk of hyperkalemia .
BACKGROUND	It has not yet been clearly known whether hyperkalemia is also induced by low-molecular-weight ( LMW ) heparins .
BACKGROUND	This study aimed to evaluate the effect of switching UF heparin to LMW heparin enoxaparin , as an anticoagulant during hemodialysis , on serum potassium level in patients on hemodialysis .
METHODS	In two hemodialysis units , 58 patients were randomly assigned into two groups , to receive two different anticoagulation protocols for 3 weeks ; one group continued to receive their routine dose of UF heparin , 5000 units , and the other received enoxaparin , 0.5 mg/kg , at the beginning of each hemodialysis session .
RESULTS	While there was no significant difference between baseline blood measurements of the two groups in terms of kidney function tests and electrolytes , following 3 weeks of the study , the mean serum potassium level decreased from 4.9 0.8 mEq/L to 4.5 0.5 mEq/L in the LMW heparin group ( P = .001 ) ; however , there was no change in the mean serum potassium level in those who continued to receive their usual dose of UF heparin .
RESULTS	In a subgroup analysis , diabetic patients in the enoxaparin group did not experience significant reduction in serum potassium levels .
CONCLUSIONS	Our study revealed the role of LMW heparins as a potential alternative to UF heparins in the hemodialysis patients with hyperkalemia .

###24351501
BACKGROUND	Antidepressants are often the first-line treatment for depression in primary care .
BACKGROUND	However , not all patients respond to medication after an adequate dose and duration of treatment .
BACKGROUND	Currently , there are no estimates of the prevalence of treatment-resistant depression ( TRD ) from UK primary care .
OBJECTIVE	To estimate the prevalence of TRD in UK primary care .
OBJECTIVE	Design and setting Data were collected as part of a multicentre randomised controlled trial , from 73 general practices in UK primary care .
METHODS	Potential participants ( aged 18-75 years who had received repeated prescriptions for antidepressants ) were identified from general practice records .
METHODS	Those who agreed to be contacted were mailed a questionnaire that included questions on depressive symptoms ( Beck Depression Inventory [ BDI-II ] ) , and adherence to antidepressants .
METHODS	Those who scored 14 on the BDI-II and had taken antidepressants for at least 6 weeks at an adequate dose were defined as treatment resistant .
RESULTS	A total of 2439 patients completed the questionnaire ( 84 % of those who agreed to be contacted ) , of whom 2129 had been prescribed an adequate dose of antidepressants for at least 6 weeks .
RESULTS	Seventy-seven per cent ( 95 % CI = 75 % to 79 % ) had a BDI score of 14 .
RESULTS	Fifty-five per cent ( 95 % CI = 53 % to 58 % ) ( n = 1177 ) met the study 's definition of TRD , of whom 67 % had taken their antidepressants for more than 12 months .
CONCLUSIONS	The high prevalence of TRD is an important challenge facing clinicians in UK primary care .
CONCLUSIONS	A more proactive approach to managing this patient population is required to improve outcome .

###25196041
OBJECTIVE	Cognitive enhancement resulting from nicotinic acetylcholine receptor stimulation may be evidenced by increased efficiency of the auditory-frontal cortex network of auditory discrimination , which is impaired in schizophrenia , a cognitive disorder associated with excessive tobacco use .
OBJECTIVE	Investigating automatic ( preattentive ) detection of acoustic change with the mismatch negativity ( MMN ) brain event-related potential in response to nicotine in individuals with varying baseline levels of auditory discrimination may provide useful insight into the cholinergic regulation of this neural network and its potential amelioration with novel nicotinic agents .
METHODS	Sixty healthy , non-smoking male volunteers were presented with an ` optimal ' multi-feature MMN paradigm in a randomized , placebo controlled double-blind design with 6mg of nicotine gum .
RESULTS	Participants with low , medium , and high baseline amplitudes responded differently to nicotine ( vs. placebo ) , and nicotine response was feature specific .
RESULTS	Whereas MMN in individuals with high amplitudes was diminished by nicotine , MMN increased in those with low amplitudes .
RESULTS	Nicotine effects were not shown in medium amplitude participants .
CONCLUSIONS	These findings provide preliminary support for the role of nicotinic neurotransmission in sensory memory processing of auditory change and suggest that nicotinic receptor modulation can both enhance and diminish change detection , depending on baseline MMN and its eliciting stimulus feature .

###25146127
BACKGROUND	Community-acquired pneumonia ( CAP ) is considered the leading cause of death from infectious disease in developed countries , while complications of CAP - sepsis being the most common and challenging - increase the risk of mortality .
BACKGROUND	During the progression of sepsis , a state of neutrophil ` paralysis ' develops resulting in the impairment of neutrophil anti-microbial functions including : chemotaxis , production of reactive oxygen species , and formation of neutrophil extracellular traps ( NETs ) .
BACKGROUND	Mechanisms underlying defective neutrophil function remain elusive although NET formation has been implicated in the immunosuppression and increased rates of sepsis observed in neonates .
BACKGROUND	There is , however , increasing evidence that statins are able to modulate neutrophil function in sepsis as several systematic reviews have concluded that statins have a role in improving infection-related outcomes and mortality while , in vitro , statins have also been shown to boost NET formation in healthy individuals .
METHODS	The ` SNOOPI ' trial is a phase 4 , randomised placebo-controlled trial .
METHODS	The aim of this study is to determine whether oral treatment with simvastatin compared to placebo optimises neutrophil anti-microbial functions in elderly patients with septic pneumonia improving patient outcomes in the elderly .
METHODS	The primary outcome will be NET production within 72 to 96 hours of treatment with simvastatin or placebo measured in response to a number of inflammatory mediators , including IL8 , f-Met-Leu-Phe and lipopolysaccharide .
METHODS	Secondary outcomes include neutrophil migratory capacity ; reactive oxygen species production ; neutrophil phagocytic capacity ; safety and tolerability of simvastatin administration within this patient group ; biological markers of neutrophil activation , the inflammatory response , alveolar epithelial and endothelial injury ; systemic endothelial function biomarkers and pulmonary extracellular matrix degradation .
METHODS	This study aims to recruit 60 patients admitted into Queen Elizabeth Hospital Birmingham NHS-Foundation Trust .
CONCLUSIONS	This study will investigate the ability of in vivo simvastatin therapy to modulate neutrophil anti-microbial functions in CAP-associated sepsis .
BACKGROUND	EudraCT number : 2012-003343-29 ( Trial Registered : 26 November 2012 ) .

###24433978
BACKGROUND	The identification of patients at risk for developing left ventricular ( LV ) remodeling after acute myocardial infarction ( AMI ) has crucial prognostic implications .
BACKGROUND	The aims of this study were ( 1 ) to investigate the relationship between peak subepicardial and subendocardial twist and infarct transmurality , as assessed using contrast-enhanced magnetic resonance imaging , and ( 2 ) to evaluate the association between peak subepicardial and subendocardial twist and LV remodeling 6 months after AMI .
METHODS	A total of 213 patients with ST-segment elevation AMIs who underwent three-dimensional echocardiography for LV volumes and functional assessment and two-dimensional speckle-tracking analysis for the evaluation of LV twist ( subendocardial vs subepicardial ) were retrospectively included .
METHODS	A subgroup of 40 patients underwent magnetic resonance imaging within 2 months for infarct size quantification .
RESULTS	Peak subepicardial twist was strongly related to infarct size ( number of segments with transmural scar : r ( 2 ) = 0.526 , P < .001 ; total scar score : r ( 2 ) = 0.515 , P < .001 ) compared with peak subendocardial twist ( number of segments with transmural scar : r ( 2 ) = 0.379 , P < .001 ; total scar score : r ( 2 ) = 0.331 , P < .001 ) .
RESULTS	In the overall population , 44 patients ( 21 % ) developed significant LV remodeling at 6-month follow-up ( LV end-systolic volume increase 15 % ) .
RESULTS	These patients showed significantly more impaired peak subepicardial and subendocardial twist at baseline compared with patients without LV remodeling ( 4.5 1.3 vs 9.4 3.5 , P < .001 ; 7.0 3.2 vs 12.9 5.8 , P < .001 , respectively ) .
RESULTS	Importantly , peak subepicardial twist ( odds ratio , 0.241 ; 95 % confidence interval , 0.134-0 .431 ; P < .001 ) and peak troponin T ( odds ratio , 1.152 ; 95 % confidence interval , 1.006-1 .320 ; P = .041 ) were independently associated with the development of LV remodeling .
CONCLUSIONS	Peak subepicardial twist strongly reflects infarct transmurality as assessed with magnetic resonance imaging and is independently associated with LV remodeling after AMI .

###26021223
OBJECTIVE	To compare the clinical outcome of single implants which underwent immediate nonocclusal loading with implants subjected to early non-occlusal loading at 3 weeks , and implants conventionally loaded at 4 months .
METHODS	One hundred and five patients in five private practices requiring a single implant-supported crown were randomised to immediate loading ( 35 patients ) , early loading ( 35 patients ) and conventional loading ( 35 patients ) groups .
METHODS	To be immediately or early loaded , implants had to be inserted with a torque superior to 45 Ncm .
METHODS	Immediately and early loaded implants received non-occluding temporary crows , whereas conventionally loaded implants were directly restored with definitive crowns .
METHODS	Temporary crowns were replaced by definitive ones after 4 months .
METHODS	Outcome measures were crown and implant failures , complications and peri-implant marginal bone level changes recorded by a blinded assessor .
RESULTS	Two patients dropped out from the immediate loading group up to 1-year post-loading .
RESULTS	Two implants failed , one in the immediately loaded and one in the early loaded group ( P = 0.601 ) .
RESULTS	One immediately loaded implant and two early loaded implants were affected by one complication each ( P = 0.162 ) .
RESULTS	Mean peri-implant marginal bone loss after 1 year was -0.1200.230 mm ( 95 % CI -0.35 , 0.10 ) for immediate , -0.3900.840 mm ( 95 % CI -1.23 , 0.45 ) for early and -0.2010.306 mm ( 95 % CI -0.51 ; 0.11 ) for conventionally loaded implants .
RESULTS	There were no statistically significant differences for any of the outcome measures between the three loading strategies up to 1-year post-loading .
CONCLUSIONS	No major clinical differences were observed with regard to implant survival , complications and marginal bone level changes when loading single implants immediately , early or conventionally .

###25002195
OBJECTIVE	Assess the effects of a home exercise programme , based on aerobic training and muscle strength training , in patients with cystic fibrosis ( CF ) , for a period of 3 months .
METHODS	Randomised controlled clinical experiment , with an analysis of intention to treat including clinically stable patients with CF and of age 16 .
METHODS	Assessments include : a 6 min walk test ( 6 MWT ) , one-repetition maximum strength test ( 1 RM ) , spirometry and quality of life questionnaires .
METHODS	The patients randomised for the exercise group exercise group followed a home exercise protocol , supervised by telephone , while the control group maintained their usual activities .
RESULTS	41 Patients were included , 22 in the control group and 19 in the exercise group .
RESULTS	The exercise group presented a significant increase in muscle strength in upper limbs ( UULL ) on the 1 RM test .
RESULTS	There was no significant difference between groups on the scores for general quality of life and specifically for CF and in the distance walked on the 6 MWT .
CONCLUSIONS	The study demonstrated that a home exercise programme had positive effects in adult patients with CF , including gain in muscle strength in UULL .
CONCLUSIONS	No increase in tolerance to exercise was shown and improvement in the quality of life of the patients who received intervention .

###24525635
OBJECTIVE	Posttraumatic stress disorder ( PTSD ) is a chronic disabling illness , resulting from exposure to extreme traumatic event .
OBJECTIVE	Although different pharmacologic agents are suggested for treatment of PTSD , none have been completely effective in eliminating symptoms .
OBJECTIVE	The purpose of this study was to assess the use of baclofen as an add-on to citalopram in treatment of PTSD .
METHODS	In this double-blind clinical trial , 40 Iranian combat veterans with PTSD were randomly assigned to 2 groups .
METHODS	The first group received a combination treatment of 20 to 60 mg/d citalopram and 40 mg/d baclofen , and the second group received 20 to 60 mg/d citalopram plus placebo .
METHODS	Symptom severity was assessed by Clinician-Administered PTSD Scale at the beginning of the study and after 2 , 4 , 6 , and 8 weeks .
METHODS	Global Assessment of Functioning and Hamilton Rating Scale for Anxiety and Depression were also used at the same periods .
METHODS	Data were analyzed with independent t test and paired t test using SPSS software version 13 ( IBM , Armonk , NY ) .
RESULTS	Twenty-three male patients ( baclofen group , 13 patients ; placebo group , 10 patients ) completed the study .
RESULTS	Dropout from the treatment was not caused by adverse effects of the new medications in any of the subjects .
RESULTS	Baclofen group showed significantly larger improvement in Clinician-Administered PTSD Scale total ( P = 0.040 ) , hyperarousal ( P = 0.020 ) , and avoidance ( 0.020 ) scores , Global Assessment of Functioning score ( 0.001 ) , depression ( P = 0.000 ) , and anxiety ( P = 0.000 ) after 8 weeks of treatment .
RESULTS	No intergroup difference was found in improvement of reexperience symptoms ( P = 0.740 ) .
CONCLUSIONS	Baclofen showed to be an effective add-on to selective serotonin reuptake inhibitors in treatment of PTSD for better symptom recovery and functional improvement .

###24752056
OBJECTIVE	We previously described the prognostic impact of tumor regression grading ( TRG ) on the outcome of patients with rectal carcinoma treated with preoperative chemoradiotherapy ( CRT ) in the CAO/ARO/AIO -94 trial .
OBJECTIVE	Here we report long-term results after a median follow-up of 132 months .
METHODS	TRG after preoperative CRT was determined in 386 surgical specimens by the amount of viable tumor cells versus fibrosis , ranging from TRG 4 ( no viable tumor cells ) to TRG 0 ( no signs of regression ) .
METHODS	Clinicopathologic parameters and TRG were correlated to the cumulative incidence of local recurrence , distant metastasis , and disease-free survival ( DFS ) .
RESULTS	Ten-year cumulative incidence of distant metastasis and DFS were 10.5 % and 89.5 % for patients with TRG 4 ( complete regression ) , 29.3 % and 73.6 % for TRG 2 and 3 ( intermediate regression ) , and 39.6 % and 63 % for TRG 0 and 1 ( poor regression ) , respectively ( P = .005 and P = .008 , respectively ) .
RESULTS	On multivariable analysis , residual lymph node metastasis ( ypN + ) and TRG were the only independent prognostic factors for cumulative incidence of distant metastasis ( P < .001 and P = .035 , respectively ) and DFS ( P < .001 and P = .039 , respectively ) , whereas local recurrence was significantly affected by ypN status ( P < .001 ) and lymphatic invasion ( P = .026 ) .
CONCLUSIONS	Complete and intermediate tumor regressions were associated with improved long-term outcome in patients with rectal carcinoma after preoperative CRT independent of clinicopathologic parameters .
CONCLUSIONS	This classification system needs to be prospectively tested in multiple data sets to validate its reproducibility in a wider setting .

###24950773
BACKGROUND	The current standard for pain control following liver surgery is intravenous , patient-controlled analgesia ( IV PCA ) or epidural analgesia .
BACKGROUND	We have developed a modification of a regional technique called medial open transversus abdominis plane ( MOTAP ) catheter analgesia .
BACKGROUND	The MOTAP technique involves surgically placed catheters through the open surgical site into a plane between the internal oblique muscle and the transverse abdominis muscle superiorly .
BACKGROUND	The objective of this trial is to assess the efficacy of this technique .
METHODS	This protocol describes a multicentre , prospective , blinded , randomized controlled trial .
METHODS	One hundred and twenty patients scheduled for open liver resection through a subcostal incision will be enrolled .
METHODS	All patients will have two MOTAP catheters placed at the conclusion of surgery .
METHODS	Patients will be randomized to one of two parallel groups : experimental ( local anaesthetic through MOTAP catheters ) or placebo ( normal saline through MOTAP catheters ) .
METHODS	Both groups will also receive IV PCA .
METHODS	The primary endpoint is mean cumulative postoperative opioid consumption over the first 2 postoperative days ( 48 hours ) .
METHODS	Secondary outcomes include pain intensity , patient functional outcomes , and the incidence of complications .
CONCLUSIONS	This trial has been approved by the ethics boards at participating centres and is currently enrolling patients .
CONCLUSIONS	Data collection will be completed by the end of 2014 with analysis mid-2015 and publication by the end of 2015 .
BACKGROUND	The study is registered with http://clinicaltrials.gov ( NCT01960049 ; 23 September 2013 ) .

###24447003
OBJECTIVE	Telephone-administered therapies have emerged as an alternative method of delivery for the treatment of depression , yet concerns persist that the use of the telephone may have a deleterious effect on therapeutic alliance .
OBJECTIVE	The purpose of this study was to compare therapeutic alliance in clients receiving cognitive behavioral therapy ( CBT ) for depression by telephone ( T-CBT ) or face-to-face ( FtF-CBT ) .
METHODS	We randomized 325 participants to receive 18 sessions of T-CBT or FtF-CBT .
METHODS	The Working Alliance Inventory ( WAI ) was administered at Weeks 4 and 14 .
METHODS	Depression was measured during treatment and over 1 year posttreatment follow-up using the Hamilton Rating Scale for Depression and Patient Health Questionnaire-9 .
RESULTS	There were no significant differences in client or therapist WAI between T-CBT or FtF-CBT ( Cohen 's f ranged from 0 to .013 , all ps > .05 ) .
RESULTS	All WAI scores predicted depression end of treatment outcomes ( Cohen 's f ranged from .009 to .06 , all ps < .02 ) .
RESULTS	The relationship between the WAI and depression outcomes did not vary by treatment group ( Cohen 's f ranged from 0 to .004 , ps > .07 ) .
RESULTS	The WAI did not significantly predict depression during posttreatment follow-up ( all ps > .12 ) .
CONCLUSIONS	Results from this analysis do not support the hypothesis that the use of the telephone to provide CBT reduces therapeutic alliance relative to FtF-CBT .

###24558280
OBJECTIVE	To design an educational activity and evaluate its effectiveness on increasing third-year pharmacy students ' knowledge and confidence to recommend self-care products to patients .
METHODS	Faculty members created a self-care activity , the Amazing Self-Care Race , for educational use in a pharmaceutical care laboratory course .
METHODS	Student teams worked competitively to complete 15 stations focused on self-care .
METHODS	A complex , real-world case was presented at each station .
METHODS	Student recommendations were presented to a facilitator .
METHODS	Prior to and following the activity , students were invited to complete an online anonymous survey instrument .
RESULTS	Eighty-six students completed presurvey and postsurvey instruments to assess their knowledge and perceived confidence to recommend a self-care product to a patient prior to and following participation in the Amazing Self-Care Race .
RESULTS	Students demonstrated a significant increase in their ability and confidence to recommend self-care products following the activity ( p < 0.001 ) .
CONCLUSIONS	The Amazing Self-Care Race is an effective educational activity that increases student knowledge and confidence in self-care therapeutics .
CONCLUSIONS	The activity helped students to develop self-care skills , enabled them to learn through doing , encouraged them to synthesize information while making self-care recommendations , and helped them to develop confidence by thinking on their feet .

###24754493
OBJECTIVE	To determine the relationship between coronary plaque detected with coronary computed tomographic ( CT ) angiography and clinical parameters and cardiovascular risk factors in asymptomatic patients with diabetes .
METHODS	All patients signed institutional review board-approved informed consent forms before enrollment .
METHODS	Two hundred twenty-four asymptomatic diabetic patients ( 121 men ; mean patient age , 61.8 years ; mean duration of diabetes , 10.4 years ) underwent coronary CT angiography .
METHODS	Total coronary artery wall volume in all three vessels was measured by using semiautomated software .
METHODS	The coronary plaque volume index ( PVI ) was determined by dividing the wall volume by the coronary length .
METHODS	The relationship between the PVI and cardiovascular risk factors was determined with multivariable analysis .
RESULTS	The mean PVI ( standard deviation ) was 11.2 mm ( 2 ) 2.7 .
RESULTS	The mean coronary artery calcium ( CAC ) score ( determined with the Agatston method ) was 382 ; 67 % of total plaque was noncalcified .
RESULTS	The PVI was related to age ( standardized = 0.32 , P < .001 ) , male sex ( standardized = 0.36 , P < .001 ) , body mass index ( BMI ) ( standardized = 0.26 , P < .001 ) , and duration of diabetes ( standardized = 0.14 , P = .03 ) .
RESULTS	A greater percentage of soft plaque was present in younger individuals with a shorter disease duration ( P = .02 ) .
RESULTS	The soft plaque percentage was directly related to BMI ( P = .002 ) .
RESULTS	Patients with discrepancies between CAC score and PVI rank quartiles had a higher percentage of soft and fibrous plaque ( 18.7 % 3.3 vs 17.4 % 3.5 [ P = .008 ] and 52.2 % 7.2 vs 47.2 % 8.8 [ P < .0001 ] , respectively ) .
CONCLUSIONS	In asymptomatic diabetic patients , BMI was the primary modifiable risk factor that was associated with total and soft coronary plaque as assessed with coronary CT angiography .

###24360749
BACKGROUND	Walnut consumption is associated with reduced risk of coronary heart disease ( CHD ) .
OBJECTIVE	We assessed the effect of walnuts on lipid and glucose metabolism , adipokines , inflammation and endothelial function in healthy Caucasian men and postmenopausal women 50years old .
METHODS	Forty subjects ( meanSEM : age 601years , BMI 24.90.6 kg/m ( 2 ) ; 30 females ) were included in a controlled , cross-over study and randomized to receive first a walnut-enriched ( 43g/d ) and then a Western-type ( control ) diet or vice-versa , with each lasting 8weeks and separated by a 2-week wash-out .
METHODS	At the beginning and end of each diet phase , measurements of fasting values , a mixed meal test and an assessment of postprandial endothelial function ( determination of microcirculation by peripheral artery tonometry ) were conducted .
METHODS	Area under the curve ( AUC ) , incremental AUC ( iAUC ) and treatmenttime interaction ( shape of the curve ) were evaluated for postprandial triglycerides , VLDL-triglycerides , chylomicron-triglycerides , glucose and insulin .
RESULTS	Compared with the control diet , the walnut diet significantly reduced non-HDL-cholesterol ( walnut vs. control : -103 vs. -32 mg/dL ; p = 0.025 ) and apolipoprotein-B ( -5.01.3 vs. -0.21.1 mg/dL ; p = 0.009 ) after adjusting for age , gender , BMI and diet sequence .
RESULTS	Total cholesterol showed a trend toward reduction ( p = 0.073 ) .
RESULTS	Fasting VLDL-cholesterol , LDL-cholesterol , HDL-cholesterol , triglycerides and glucose , insulin , HOMA-IR , and HbA1c did not change significantly .
RESULTS	Similarly , fasting adipokines , C-reactive protein , biomarkers of endothelial dysfunction , postprandial lipid and glucose metabolism and endothelial function were unaffected .
CONCLUSIONS	Daily consumption of 43g of walnuts for 8weeks significantly reduced non-HDL-cholesterol and apolipoprotein-B , which may explain in part the epidemiological observation that regular walnut consumption decreases CHD risk .

###25423960
OBJECTIVE	A subgroup of oropharyngeal squamous cell carcinoma ( OPC ) is infected with high-risk human papillomavirus ( HPV ) .
OBJECTIVE	The object of this study is to evaluate the efficacy of adjuvant chemotherapy with S-1 , an oral 5-fluorouracil prodrug , on survival of patients with OPC according to HPV status .
METHODS	Among OPC patients of stage III or IV who received definitive treatment from 1998 to 2008 , 38 who were confirmed tumor-free after primary treatment were analyzed .
METHODS	Before 2003 , none of the patients received S-1 adjuvant chemotherapy ( S-1 ( - ) - group ) ; however , all patients who were eligible were administered S-1 ( S-1 ( + ) - group ) after 2003 .
METHODS	The expression of thymidylate synthase ( TYMS ) involved in 5-FU metabolism was also examined in protein and mRNA levels .
RESULTS	Although there was a trend to disease-free and overall survival benefit in HPV-negative patients with S-1 , it did not achieve statistical significance ( P = .082 and P = .065 , respectively ) .
RESULTS	For the HPV-positive patients , the survivals were similar with or without S-1 administration .
RESULTS	TYMS-expression in HPV-positive OPC tissues was significantly higher than in HPV-negative ones in both protein and mRNA levels ( P = .0489 and P = .0446 , respectively ) .
CONCLUSIONS	The current study provides a rationale to plan a randomized trial to compare the efficacy of S-1 according to the HPV status in OPCs .

###24416197
BACKGROUND	It is an inherent assumption in randomised controlled trials that the drug effect can be estimated by subtracting the response during placebo from the response during active drug treatment .
OBJECTIVE	To test the assumption of additivity .
OBJECTIVE	The primary hypothesis was that the total treatment effect is smaller than the sum of the drug effect and the placebo effect .
OBJECTIVE	The secondary hypothesis was that non-additivity was most pronounced in participants with large placebo effects .
METHODS	We used a within-subject randomised blinded balanced placebo design and included 48 healthy volunteers ( 50 % males ) , mean ( SD ) age 23.4 ( 6.2 ) years .
METHODS	Experimental pain was induced by injections of hypertonic saline into the masseter muscle .
METHODS	Participants received four injections with hypertonic saline along with lidocaine or matching placebo in randomised order : A : received hypertonic saline/told hypertonic saline ; B : received hypertonic saline + lidocaine/told hypertonic saline ; C : received hypertonic saline + placebo/told hypertonic saline + pain killer ; D : received hypertonic saline + lidocaine/told hypertonic saline + pain killer .
METHODS	The primary outcome measure was the area under the curve ( AUC , mm ( 2 ) ) of pain intensity during injections .
RESULTS	There was a significant difference between the sum of the drug effect and the placebo effect ( mean AUC 6279 mm ( 2 ) ( 95 % CI , 4936-7622 ) ) and the total treatment effect ( mean AUC 5455 mm ( 2 ) ( 95 % CI , 4585-6324 ) ) ( P = 0.049 ) .
RESULTS	This difference was larger for participants with large versus small placebo effects ( P = 0.015 ) , and the difference correlated significantly with the size of the placebo effect ( r = 0.65 , P = 0.006 ) .
CONCLUSIONS	Although this study examined placebo effects and not the whole placebo response as in randomised controlled trials , it does suggest that the additivity assumption may be incorrect , and that the estimated drug effects in randomised controlled trials may be underestimated , particularly in studies reporting large placebo responses .
CONCLUSIONS	The implications for randomised controlled trials and systematic reviews need to be discussed .

###24716628
BACKGROUND	Cardiovascular diseases ( CVD ) are a leading cause of death worldwide including the Middle East .
BACKGROUND	This is caused in part by the dysregulation of adipose tissue leading to increased production of pro-inflammatory adipokines and reduction in cardio-protective adipokines such as adiponectin .
BACKGROUND	Ethnicity has been recognized as a major factor in the association between CVD risk factors and the different circulating adipokines .
BACKGROUND	In this study , for the first time , the relationship between traditional cardiovascular risk factors , Metabolic Syndrome ( MetS ) and circulating level of adipokines in Arab ethnicity was investigated .
METHODS	We conducted a population-based cross-sectional survey on 379 adult Arab participants living in Kuwait .
METHODS	Traditional cardiovascular risk factors such as blood pressure ( BP ) , low density lipoprotein ( LDL ) and triglyceride ( TG ) were measured .
METHODS	Plasma levels of circulating Leptin , Plasminogen Activator Inhibitor ( PAI-1 ) visfatin , adiponectin , resistin and adipsin were assessed using the multiplexing immunobead-based assay .
RESULTS	Circulating levels of High sensitivity C-Reactive Protein ( hsCRP ) , Leptin , PAI-1 and adiponectin were significantly higher in Arab women than men ( p < 0.0001 ) .
RESULTS	In multi-variate analysis , the homeostasis model assessment-insulin resistance ( HOMA-IR ) and body mass index ( BMI ) showed strong association with most of the biomarkers ( p < 0.05 ) .
RESULTS	HsCRP showed significant association with all risk factors ( p < 0.05 ) .
RESULTS	Leptin , PAI-1 and adipsin showed significant positive correlation with BMI , unlike adiponectin which showed inverse correlation ( p < 0.05 ) .
RESULTS	Subjects in the highest tertile of leptin , PAI-1 and hsCRP had higher odds of having Metabolic Syndrome ( MetS ) ( odd ratio [ OR ] = 3.02 , 95 % confidence interval [ CI ] = 1.47-6 .19 ) and ( OR = 2.52 , 95 % CI = 1.45-4 .35 ) , ( OR = 4.26 , 95 % CI = 2.39-7 .59 ) respectively .
RESULTS	On the other hand subjects with highest tertile of adiponectin had lower odds of having MetS ( OR = 0.22 , 95 % CI = 0.12-0 .40 ) .
RESULTS	Leptin , PAI-1 and hsCRP showed significant positive association with increased MetS components ( P-trend < 0.05 ) , while adiponectin was negatively associated with increased MetS components ( P-trend < 0.0001 ) .
CONCLUSIONS	Our results show positive association between hsCRP , leptin , PAI-1 with increased MetS components and increase the odds of having MetS .
CONCLUSIONS	Adiponectin on the other hand showed inverse correlation with MetS components and associated with reduction in MetS .
CONCLUSIONS	Overall , our data highlights the significant clinical value these markers have in MetS especially hsCRP which can be used as good marker of low grade inflammation in Arabs .

###24599749
BACKGROUND	Studies utilizing beta-hydroxy-beta-methylbutyrate ( HMB ) supplementation in trained populations are limited .
BACKGROUND	No long-term studies utilizing HMB free acid ( HMB-FA ) have been conducted .
BACKGROUND	Therefore , we investigated the effects of 12 weeks of HMB-FA supplementation on skeletal muscle hypertrophy , body composition , strength , and power in trained individuals .
BACKGROUND	We also determined the effects of HMB-FA on muscle damage and performance during an overreaching cycle .
METHODS	A three-phase double-blind , placebo - and diet-controlled randomized intervention study was conducted .
METHODS	Phase 1 was an 8-week-periodized resistance-training program ; Phase 2 was a 2-week overreaching cycle ; and Phase 3 was a 2-week taper .
METHODS	Muscle mass , strength , and power were examined at weeks 0 , 4 , 8 , and 12 to assess the chronic effects of HMB-FA ; and assessment of these , as well as cortisol , testosterone , and creatine kinase ( CK ) was performed at weeks 9 and 10 of the overreaching cycle .
RESULTS	HMB-FA resulted in increased total strength ( bench press , squat , and deadlift combined ) over the 12-week training ( 77.1 18.4 vs. 25.3 22.0 kg , p < 0.001 ) ; a greater increase in vertical jump power ( 991 168 vs. 630 167 W , p < 0.001 ) ; and increased lean body mass gain ( 7.4 4.2 vs. 2.1 6.1 kg , p < 0.001 ) in HMB-FA - and placebo-supplemented groups , respectively .
RESULTS	During the overreaching cycle , HMB-FA attenuated increases in CK ( -6 91 vs. 277 229 IU/l , p < 0.001 ) and cortisol ( -0.2 2.9 vs. 4.5 1.7 g/dl , p < 0.003 ) in the HMB-FA - and placebo-supplemented groups , respectively .
CONCLUSIONS	These results suggest that HMB-FA enhances hypertrophy , strength , and power following chronic resistance training , and prevents decrements in performance following the overreaching .

###24338947
BACKGROUND	The current study tested whether perceived social support serves as a mediator of anxiety and depressive symptom change following evidence-based anxiety treatment in the primary care setting .
BACKGROUND	Gender , age , and race were tested as moderators .
METHODS	Data were obtained from 1004 adult patients ( age M = 43 , SD = 13 ; 71 % female ; 56 % White , 20 % Hispanic , 12 % Black ) who participated in a randomized effectiveness trial ( coordinated anxiety learning and management [ CALM ] study ) comparing evidence-based intervention ( cognitive-behavioral therapy and/or psychopharmacology ) to usual care in the primary care setting .
METHODS	Patients were assessed with a battery of questionnaires at baseline , as well as at 6 , 12 , and 18 months following baseline .
METHODS	Measures utilized in the mediation analyses included the Abbreviated Medical Outcomes ( MOS ) Social Support Survey , the Brief Symptom Index ( BSI ) - Somatic and Anxiety subscales , and the Patient Health Questionnaire ( PHQ-9 ) .
RESULTS	There was a mediating effect over time of perceived social support on symptom change following treatment , with stronger effects for 18-month depression than anxiety .
RESULTS	None of the mediating pathways were moderated by gender , age , or race .
CONCLUSIONS	Perceived social support may be central to anxiety and depressive symptom changes over time with evidence-based intervention in the primary care setting .
CONCLUSIONS	These findings possibly have important implications for development of anxiety interventions .

###25090853
BACKGROUND	The article presents the results of psychosocial burdens in special educators ( specialists in the field of oligophrenopedagogy ) with intellectually disabled students .
BACKGROUND	In theoretical part , specific context of occupational stress in special educators was introduced .
BACKGROUND	Additionally , the need of broader research context regarding occupational stress and the risk of burnout in special educators working with intellectually disabled individuals were included .
METHODS	The results were obtained using Plichta and Pyzalski 's Questionnaire of Occupational Burdens in Teaching ( QOBT ) .
METHODS	The presented results are based on a research sample ( N = 100 ) of special educators ( female ) teaching intellectually disabled students attending special schools in the city of Ldz .
METHODS	The obtained results were compared with the results coming from a large random sample of public school teachers working with non-intellectually disabled children from the Lodi voivodeship ( N = 429 ) and referred to the norms of QOBT .
RESULTS	The results show significant percentage of respondents obtaining high level of occupational burdens ( conflict situations - 45 % , organizational burdens - 31 % , lack of work sense - 40 % , global score - 40 % ) .
RESULTS	Seniority is not related to the level of burdens .
RESULTS	Some significant differences concerning the level of occupational burdens between both groups of teachers were found .
CONCLUSIONS	The study showed e.g. the strong need for supporting special educators in the workplace context and the need of implementing preventive and remedial measures at both individual and organizational levels ( especially in terms of improving personal relationships in a workplace ) .
CONCLUSIONS	Generally , the results show similarity of the stressors ' ranking in special educators and school teachers working with non-intellectually disabled children .

###25233856
BACKGROUND	Chronic kidney disease ( CKD ) is public health concern even in Asian countries .
BACKGROUND	TRK-100STP , a sustained release tablet of an orally-active prostacyclin analogue , beraprost sodium , is suggested to suppress worsening of some parameters of renal filtration function , containing in slope of 1/serum creatinine ( 1/SCr ) vs. time in a phase II clinical trial .
METHODS	We describe the design of the phase IIb/III trial of TRK-100STP , CASSIOPEIR ( CRF Asian Study with Oral PGI2 derivative for Evaluating Improvement of Renal function ) conducted in approximately 160 centers in China , Hong Kong , Japan , Malaysia , Republic of Korea , Taiwan , and Thailand .
METHODS	A total of 750 patients ( n = 250 per group ) with primary glomerular disease or nephrosclerosis were planned to be enrolled .
METHODS	Patients were randomized into one of three treatment groups in a double-bind , placebo-controlled manner : TRK-100STP 60 g b.i.d. ; TRK-100STP 120 g b.i.d. ; or placebo .
METHODS	The treatment period is planned to last 2 to 4 years .
METHODS	The primary efficacy endpoint is the renal composite endpoint including doubling of SCr and ESRD ( dialysis induction , renal transplantation , or increase in SCr to 6.0 mg/dL ) .
CONCLUSIONS	This trial targeting CKD patients is designed to ( a ) demonstrate the superiority of TRK-100STP over placebo using renal composite endpoints , ( b ) determine the recommended clinical dose , and ( c ) assess the safety of TRK-100STP in this population and setting .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01090037 .

###25280934
BACKGROUND	Indacaterol is a long-acting beta-2 agonist for once-daily treatment of COPD .
BACKGROUND	We evaluated the effects of indacaterol 150g on lung hyperinflation compared with placebo and open-label tiotropium 18g .
BACKGROUND	We measured physical activity during treatment with indacaterol 150g and matched placebo .
METHODS	We performed a randomized , three-period , cross-over study ( 21days of treatment separated by two wash-out periods of 13days ) with indacaterol 150g or matching placebo and tiotropium 18g .
METHODS	Lung function was assessed by body plethysmography and spirometry .
METHODS	Physical activity was measured for one week by a multisensory armband at the end of both treatment periods with indacaterol/matched placebo .
METHODS	The primary endpoint was peak inspiratory capacity at the end of each treatment period .
RESULTS	129 patients ( mean age , 61years ; mean post-bronchodilator FEV1 , 64 % ) , were randomized and 110 patients completed the study .
RESULTS	Peak inspiratory capacity was 0.22 L greater with Indacaterol at day 21 compared to placebo ( p < 0.001 ) .
RESULTS	Similar results were observed for tiotropium .
RESULTS	Both bronchodilators also significantly improved other parameters of lung hyperinflation compared with placebo .
RESULTS	All parameters of physical activity were significantly increased during treatment with indacaterol versus placebo .
CONCLUSIONS	Indacaterol 150g improved lung hyperinflation in patients with moderate COPD , which was associated with an increase of physical activity .
BACKGROUND	ClinicalTrials.gov registration number : NCT01012765 .

###25099079
OBJECTIVE	Available drug treatments for bipolar disorder fail to reverse patients ' cognitive deficits .
OBJECTIVE	Erythropoietin has neurotrophic actions and aids neurocognitive function .
OBJECTIVE	The aim of the study was to investigate the potential of erythropoietin to treat cognitive dysfunction in bipolar disorder .
METHODS	Patients with an ICD-10 diagnosis of bipolar disorder in remission were randomized , with stratification by age and gender , to receive 8 weekly erythropoietin ( 40,000 IU ) or saline ( sodium chloride [ NaCl ] , 0.9 % ) infusions in a double-blind , parallel-group design .
METHODS	The first patient was randomized in September 2009 and last assessment was completed in October 2012 .
METHODS	Patients were assessed at baseline and at weeks 9 and 14 .
METHODS	The primary outcome was change in verbal memory indexed by the total words recalled across Rey Auditory Verbal Learning Test learning trials ( I-V ) from baseline to week 9 ; secondary outcomes were sustained attention and facial expression recognition ; and tertiary outcomes were attention , executive function , subjective cognitive function , and mood .
METHODS	Analysis was by intention to treat , using repeated-measures analysis of covariance adjusted for stratification variables and mood .
METHODS	The statistical threshold for which results were considered significant was P .05 ( 2-tailed ) .
RESULTS	44 patients were randomized ; given 1 dropout after baseline , results were analyzed for 43 patients ( erythropoietin : n = 23 ; saline : n = 20 ) .
RESULTS	There was no significant improvement of verbal memory in erythropoietin versus saline groups ( P = .10 ) .
RESULTS	However , erythropoietin enhanced sustained attention ( P = .001 ) , recognition of happy faces ( P = .03 ) , and speed of complex information processing across learning , attention , and executive function ( P = .01 ) .
RESULTS	These effects occurred in absence of changes in simple reaction times or mood ( P values .16 ) and were maintained after red blood cell normalization .
CONCLUSIONS	This is the first trial investigating erythropoietin to treat cognitive dysfunction in bipolar disorder .
CONCLUSIONS	The findings highlight erythropoietin as a candidate treatment for deficits in attention and executive function in bipolar disorder .
BACKGROUND	ClinicalTrials.gov identifier : NCT00916552 .

###24336297
OBJECTIVE	The objective was to compare retinal morphology and function following intravitreal injections of bevacizumab ( Avastin ) or triamcinolone ( Volon A ) in patients with early diabetic macular edema ( DME ) .
METHODS	The study was planned as a randomized , prospective , interventional clinical trial .
METHODS	A total of 30 diabetic patients with treatment-nave , clinically significant macular edema were included in this study and randomized to two equal groups .
METHODS	One group initially received three injections of 2.5 mg bevacizumab in monthly intervals .
METHODS	The second group received a single injection of 8 mg triamcinolone , followed by two sham interventions .
METHODS	Functional and anatomic results were evaluated monthly using ETDRS vision charts and spectral-domain optical coherence tomography .
METHODS	According to the study protocol , retreatment after 3 months was dependent on functional and anatomic outcome in a PRN regimen .
RESULTS	Baseline best corrected visual acuity ( BCVA ) was 0.30 logMAR and central retinal subfield thickness ( CSRT ) was 505m in the bevacizumab group and 0.32 logMAR and 490 m CSRT in the triamcinolone group .
RESULTS	After 3 months , BCVA improved to 0.23 logMAR ( bevacizumab ) and 358 m CRST and 0.26 logMAR ( triamcinolone ) and 308m CSRT .
RESULTS	After 12 months , BCVA further recovered in the bevacizumab group ( 0.18 logMAR ) but slightly decreased in the triamcinolone group ( 0.36 logMAR ) .
CONCLUSIONS	Intravitreal bevacizumab and triamcinolone are both equally effective in reducing CSRT in early DME .
CONCLUSIONS	After 6 months , rehabilitation of vision was comparable in both treatment arms , whereas at the final follow-up at month 12 , BCVA was superior in the bevacizumab than in the triamcinolone sample .
CONCLUSIONS	This may be related to cataract development following steroid treatment , as well as to substance-specific mechanisms within the angiogenic versus the inflammatory cascade .

###25349310
OBJECTIVE	To determine the prevalence and characteristics of fetal alcohol spectrum disorders ( FASD ) among first grade students ( 6 - to 7-year-olds ) in a representative Midwestern US community .
METHODS	From a consented sample of 70.5 % of all first graders enrolled in public and private schools , an oversample of small children ( 25th percentile on height , weight , and head circumference ) and randomly selected control candidates were examined for physical growth , development , dysmorphology , cognition , and behavior .
METHODS	The children 's mothers were interviewed for maternal risk .
RESULTS	Total dysmorphology scores differentiate significantly fetal alcohol syndrome ( FAS ) and partial FAS ( PFAS ) from one another and from unexposed controls .
RESULTS	Alcohol-related neurodevelopmental disorder ( ARND ) is not as clearly differentiated from controls .
RESULTS	Children who had FASD performed , on average , significantly worse on 7 cognitive and behavioral tests and measures .
RESULTS	The most predictive maternal risk variables in this community are late recognition of pregnancy , quantity of alcoholic drinks consumed 3 months before pregnancy , and quantity of drinking reported for the index child 's father .
RESULTS	From the final multidisciplinary case findings , 3 techniques were used to estimate prevalence .
RESULTS	FAS in this community likely ranges from 6 to 9 per 1000 children ( midpoint , 7.5 ) , PFAS from 11 to 17 per 1000 children ( midpoint , 14 ) , and the total rate of FASD is estimated at 24 to 48 per 1000 children , or 2.4 % to 4.8 % ( midpoint , 3.6 % ) .
CONCLUSIONS	Children who have FASD are more prevalent among first graders in this Midwestern city than predicted by previous , popular estimates .

###24446242
OBJECTIVE	Cancer-associated inflammation plays a driver role in pancreatic tumor development and progression .
OBJECTIVE	Moreover , recent studies have implicated the inflammatory tumor microenvironment in modulating therapy response and inducing resistance .
OBJECTIVE	The aim of this study is to investigate the prognostic and predictive value of the inflammatory biomarkers serum ferritin and C-reactive protein ( CRP ) in advanced pancreatic cancer patients .
METHODS	We measured pretreatment serum ferritin and CRP levels in 159 patients with inoperable pancreatic cancer participating in a phase III trial .
RESULTS	Serum ferritin and CRP levels were examined for correlations with overall survival using Kaplan-Meier analysis .
RESULTS	When analyzed on a categorical basis , patients with higher ferritin ( > median ) or CRP ( > 25th percentile ) had shorter overall survival .
RESULTS	Moreover , the two biomarkers were not correlated suggesting independent mechanisms of production and release .
RESULTS	However , when patients were evaluated by their ferritin and CRP levels , only patients with elevation in both inflammatory biomarkers showed a significant decrease in overall survival .
CONCLUSIONS	Serum ferritin and CRP are independent prognostic factors for shorter survival in patients with inoperable pancreatic tumors .
CONCLUSIONS	Moreover , the evaluation of patients based on both biomarkers suggested that their prognostic value , although independent , reflected the broader state of cancer-associated inflammation .
CONCLUSIONS	Thus , serum ferritin and CRP should be further explored as clinical biomarkers .

###26356398
OBJECTIVE	To study efficacy and safety of baclofen for treatment of alcohol dependence .
METHODS	32 patients with alcohol dependence had been randomized into one of two treatment groups ( 16 patients in each ) : patients of the 1st group were treated with baclofen ( 50 mg/day ) for 3 months while patients of the 2nd one received identically looking placebo .
METHODS	All the study subjects were scheduled to come to the clinic on the weekly basis to control alcohol use and compliance with the study medications ( by riboflavin marker in urine ) and also - for psychiatric evaluations ( severity of craving for alcohol , anxiety and depression ) .
METHODS	Alcohol use evaluated with the Time Line Follow Back technique and gamma-glutamiltranspeptidase activity in blood .
METHODS	To assess anxiety Spielberger state-trait inventory and Hamilton scale were used .
METHODS	Depression was assessed with Montgomery-Ashberg scale .
METHODS	To evaluate carving for alcohol used Obsessive-Compulsive Drinking scale , Penn Alcohol Craving scale , and Visual Analog Scale of Craving .
METHODS	Overall treatment effect assessed with the Clinical Global Impression scale .
METHODS	The study design was double blind .
CONCLUSIONS	Baclofen did no differ significantly from placebo on either of primary or secondary outcome variables .
CONCLUSIONS	However , primary outcome variables of retention in treatment and drinking were slightly better in the baclofen group compared to placebo , and those differences were close to the level of statistical significance .
CONCLUSIONS	There were no differences between the groups in either rate of adverse events or liver enzymes activity which is an evidence of safety and good tolerability of baclofen in alcohol dependent patients .
CONCLUSIONS	Further studies of baclofen for alcohol dependence in the larger sample size are needed .

###25078977
BACKGROUND	Pregabalin ( Lyrica ( ) ) is approved as an immediate-release ( IR ) formulation for administration twice ( BID ) or three times ( TID ) a day depending on indication .
BACKGROUND	Once daily ( QD ) dosing may be appropriate for ease of clinical use and patient convenience .
OBJECTIVE	The objectives of this analysis were : ( 1 ) to evaluate the pharmacokinetics of pregabalin controlled-release ( CR ) administered with food relative to the pregabalin IR formulation administered fasted ; ( 2 ) to evaluate the pharmacokinetics of a two-tablet dose of pregabalin CR compared with the equivalent one-tablet dose of pregabalin CR ; and ( 3 ) to determine the safety and tolerability of multiple-dose administration of pregabalin CR and IR .
METHODS	The pharmacokinetic properties of pregabalin CR were determined in four phase I , open-label , multiple-dose crossover studies ( 18-24 participants/study ) .
METHODS	Pregabalin CR ( 82.5 , 165 , 330 or 660mg/day ) administered QD was compared with pregabalin IR ( 75 , 150 , 300 or 600mg/day , respectively ) administered either BID or TID .
METHODS	Blood samples were collected up to 24h post-dose .
METHODS	Pharmacokinetic parameters were estimated from plasma concentration-time data using standard noncompartmental methods .
METHODS	Adverse events were monitored throughout all studies .
RESULTS	Eight-four healthy participants ( 19-55years of age ) received pregabalin .
RESULTS	For all pregabalin CR doses , total exposure was equivalent to the corresponding pregabalin IR dose .
RESULTS	Relative bioavailability of pregabalin CR was 93-97 % of pregabalin IR , and bioequivalence criteria with respect to the 24-h steady-state exposure ( area under the plasma concentration-time curve from 0 to 24h [ AUC24 ] ) were met .
RESULTS	Administration of a two-tablet dose of pregabalin CR was bioequivalent to one-tablet pregabalin CR .
RESULTS	The relative bioavailability of two-tablet pregabalin CR was 97-102 % of one-tablet pregabalin CR , and bioequivalence criteria with respect to AUC24 and peak plasma concentrations were met .
RESULTS	Pregabalin CR pharmacokinetic parameters were dose proportional following administration of 82.5-660mg / day pregabalin CR .
RESULTS	Pregabalin was well tolerated across studies , with no serious or severe adverse events .
CONCLUSIONS	Total daily exposure with multiple-dose pregabalin CR is equivalent to the corresponding pregabalin IR dose .

###24286636
BACKGROUND	The radial artery ( RA ) is a useful conduit for coronary artery bypass grafting ( CABG ) but is susceptible to vasospasm during harvesting .
BACKGROUND	We evaluated the usefulness of fasudil , a Rho kinase inhibitor , in dilating the RA graft and increasing graft free flow ( GFF ) compared with the conventional graft-dilating agents papaverine and verapamil-nitroglycerin ( VG ) .
METHODS	Between June 2012 and January 2013 , 45 patients with ischemic heart disease who underwent isolated CABG using the RA were enrolled and randomly assigned to fasudil ( n = 15 ) , papaverine ( n = 15 ) , or VG ( n = 15 ) .
METHODS	Fasudil ( 2.67 mmol/L ) , papaverine ( 1.0 mmol/L ) mixed with heparinized blood , or VG ( 30 mol/L each of verapamil and nitroglycerin ) was injected intraluminally into the RA graft after harvesting .
METHODS	Main outcome measures were RA GFF , hemodynamic changes , and histopathologic examination of the RA .
RESULTS	In the fasudil group , GFF increased significantly ( p < 0.001 ) from 36.8 20.4 at baseline to 148.0 88.3 mL/min after injection .
RESULTS	GFF increased significantly ( p < 0.001 ) from 36.0 19.0 to 72.3 36.7 mL/min in the papaverine group and increased significantly ( p < 0.001 ) from 39.5 23.3 to 64.3 29.9 mL/min in the VG group .
RESULTS	The GFF was significantly higher ( p = 0.001 ) in fasudil-treated RA than in papaverine - or VG-treated RA .
RESULTS	Histopathologically , RA graft diameter was markedly increased after fasudil injection , and the structure of the multiple elastic lamellae was intact .
RESULTS	Blood pressure did not change significantly after drug injection in all groups .
CONCLUSIONS	Fasudil exhibited a very potent vasodilatory effect on the RA compared with conventional papaverine or VG , resulting in increased GFF .
CONCLUSIONS	This agent is useful for dilating RA grafts in CABG .

###25031533
OBJECTIVE	The objective of this pilot trial was to evaluate the safety and efficacy of AKL1 , a patented botanical formulation containing extracts of Picrorhiza kurroa , Ginkgo biloba , and Zingiber officinale , as add-on therapy for patients with chronic obstructive pulmonary disease ( COPD ) and chronic cough .
METHODS	This randomized , double-blind , placebo-controlled trial enrolled male and female patients > 18 years old with COPD and Leicester Cough Questionnaire ( LCQ ) score of < 18 .
METHODS	The 10-week study period comprised a 2-week single-blind placebo run-in period followed by add-on treatment with AKL1 or placebo twice daily for 8 weeks .
METHODS	The primary study endpoint was the change from week 0 to week 8 in cough-related health status , as assessed by the LCQ .
RESULTS	Of 33 patients enrolled , 20 were randomized to AKL1 and 13 to placebo .
RESULTS	Patients included 19 ( 58 % ) men and 14 ( 42 % ) women of mean ( standard deviation [ SD ] ) age of 67 ( 9.4 ) years ; 15 ( 45 % ) patients were smokers and 16 ( 49 % ) were ex-smokers .
RESULTS	The mean ( SD ) change from baseline in LCQ score at 8 weeks was 2.3 ( 4.9 ) in the AKL1 group and 0.6 ( 3.7 ) in the placebo group , with mean difference in change of 1.8 ( 95 % confidence interval : -1.5 to 5.1 ; P = 0.28 ) .
RESULTS	The St George 's Respiratory Questionnaire score improved substantially in the AKL1 treatment group by a mean ( SD ) of -7.7 ( 11.7 ) versus worsening in the placebo group ( +1.5 [ 9.3 ] ) , with mean difference in change of -9.2 ( 95 % confidence interval : -19.0 to 0.6 ; P = 0.064 ) .
RESULTS	There were no significant differences between treatment groups in change from baseline to week 8 in other patient-reported measures , lung function , or the 6-minute walk distance .
CONCLUSIONS	Further study is needed with a larger patient population and over a longer duration to better assess the effects of add-on therapy with AKL1 in COPD .

###25671683
OBJECTIVE	Smokers with depressive symptoms have more difficulty quitting smoking than the general population of smokers .
OBJECTIVE	The present study examines a web-based treatment using acceptance and commitment therapy ( ACT ) for smokers with depressive symptoms .
OBJECTIVE	The study aimed to determine participant receptivity to the intervention and its effects on smoking cessation , acceptance of internal cues , and depressive symptoms .
METHODS	Smokers who had positive screening results for depressive symptoms at baseline ( n = 94 ) were selected from a randomized controlled trial ( N = 222 ) comparing web-based ACT for smoking cessation ( WebQuit.org ) with Smokefree.gov .
METHODS	Forty-five participants ( 48 % ) completed the three-month follow-up .
RESULTS	Compared to Smokefree.gov , WebQuit participants spent significantly more time on site ( p = .001 ) and had higher acceptance of physical cravings ( p = .033 ) .
RESULTS	While not significant , WebQuit participants were more engaged and satisfied with their program and were more accepting of internal cues overall .
RESULTS	There was preliminary evidence that WebQuit participants had higher quit rates ( 20 % versus 12 % ) and lower depressive symptoms at follow-up ( 45 % versus 56 % ) than those in Smokefree.gov .
CONCLUSIONS	This was the first study of web-based ACT for smoking cessation among smokers with depressive symptoms , with promising evidence of receptivity , efficacy , impact on a theory-based change process , and possible secondary effects on depression .
CONCLUSIONS	A fully powered trial of the ACT WebQuit.org intervention specifically for depressed smokers is needed .
CONCLUSIONS	This was part of a clinical trial registered as NCT # 01166334 at www.clinicaltrials.gov .

###24325639
BACKGROUND	Students in German medical schools frequently complain that the subject ` clinical examination ' is not taught in a satisfying manner due to time constraints and lack of personnel resources .
BACKGROUND	While the effectiveness and efficiency of practice-oriented teaching in small groups using near-peer teaching has been shown , it is rarely used in German medical schools .
BACKGROUND	We investigated whether adding a new near-peer teaching course developed with student input plus patient examination under supervision in small groups improves basic clinical examination skills in third year medical students compared to a traditional clinical examination course alone .
METHODS	Third year medical students registered for the mandatory curricular clinical examination course at the medical faculty of the Technische Universitt Mnchen were invited to participate in a randomised trial with blinded outcome assessment .
METHODS	Students were randomised to the control group participating in the established curricular physical examination course or to the intervention group , which received additional near-peer teaching for the same content .
METHODS	The learning success was verified by a voluntary objective structured clinical examination ( OSCE ) .
RESULTS	A total of 84 students were randomised and 53 ( 63 % ) participated in the final OSCE .
RESULTS	Students in the control group scored a median of 57 % ( 25th percentile 47 % , 75th percentile 61 % ) of the maximum possible total points of the OSCE compared to 77 % ( 73 % , 80 % ; p < 0.001 ) for students in the intervention group .
RESULTS	Only two students in the intervention group received a lower score than the best student in the control group .
CONCLUSIONS	Adding a near-peer teaching course to the routine course significantly improved the clinical examination skills of medical students in an efficient manner in the context of a resource-constrained setting .

###24732833
METHODS	A prospective randomized study .
OBJECTIVE	To compare occupational radiation exposure to the surgeon , as well as the patient , during posterior lumbar spine instrumentation in 10 navigated cases ( navigated ) versus 11 cases using the freehand technique ( non-navigated ) .
BACKGROUND	The use of navigation increases the accuracy of posterior lumbar instrumentation.A further speculated benefit of navigation is the reduction of radiation exposure of the surgeon .
BACKGROUND	However , this has so far not been evaluated in such comparative manner .
METHODS	Radiation exposure to the surgeon was measured by digital dosimeters placed at the level of the eye , chest , and dominant forearm .
METHODS	Radiation exposure was measured from the time of positioning of the patient to the end of the procedure both for navigated ( intraoperative 3-dimensional [ 3D ] fluoroscopy-based ) and non-navigated ( 2-dimensional fluoroscopy-guided ) freehand posterior lumbar spine instrumentations .
METHODS	A 3D fluoroscopic scan was routinely performed at the end of the procedure for all patients .
RESULTS	Patients were distributed evenly in the 2 groups in terms of sex , age , body mass index , and the number of operated levels .
RESULTS	The accumulated radiation dose for the surgeon was significantly higher in the non-navigated group ; up to 9.96 times .
RESULTS	The radiation dose for the patient was higher with the freehand technique , 1884.8 cGycm ( non-navigated ) versus 887 cGycm ( navigated ) , without reaching a statistically significant level .
CONCLUSIONS	Radiation exposure to the surgeon during pedicle screw placement with the freehand technique is up to 9.96 times greater than with the use of navigation .
CONCLUSIONS	In the latter group , the only radiation exposure comes from the preoperative-level control and positioning of the 3D C-arm before 3D fluoroscopic acquisition .
CONCLUSIONS	Furthermore , neuronavigation also reduces the cumulative dose for the patient .
METHODS	2 .

###24642620
BACKGROUND	Our previous laboratory and clinical data suggested that one mechanism underlying the development of platinum resistance in ovarian cancer is the acquisition of DNA methylation .
BACKGROUND	We therefore tested the hypothesis that the DNA hypomethylating agent 5-aza-2 ' - deoxycytodine ( decitabine ) can reverse resistance to carboplatin in women with relapsed ovarian cancer .
METHODS	Patients progressing 6-12 months after previous platinum therapy were randomised to decitabine on day 1 and carboplatin ( AUC 6 ) on day 8 , every 28 days or carboplatin alone .
METHODS	The primary objective was response rate in patients with methylated hMLH1 tumour DNA in plasma .
RESULTS	After a pre-defined interim analysis , the study closed due to lack of efficacy and poor treatment deliverability in 15 patients treated with the combination .
RESULTS	Responses by GCIG criteria were 9 out of 14 vs 3 out of 15 and by RECIST were 6 out of 13 vs 1 out of 12 for carboplatin and carboplatin/decitabine , respectively .
RESULTS	Grade 3/4 neutropenia was more common with the combination ( 60 % vs 15.4 % ) as was G2/3 carboplatin hypersensitivity ( 47 % vs 21 % ) .
CONCLUSIONS	With this schedule , the addition of decitabine appears to reduce rather than increase the efficacy of carboplatin in partially platinum-sensitive ovarian cancer and is difficult to deliver .
CONCLUSIONS	Patient-selection strategies , different schedules and other demethylating agents should be considered in future combination studies .

###25456798
OBJECTIVE	To evaluate the impact of Playworks on students ' physical activity during recess .
METHODS	Twenty-seven elementary schools from six U.S. cities were grouped into blocks and randomly assigned to implement Playworks ( treatment ) or not ( control ) during an entire school year ( either 2010-2011 or 2011-2012 ) .
METHODS	Study data were collected at the end of the school year only .
METHODS	Fourth - and 5th-grade students ( n = 2278 ) reported on their physical activity during recess , and a subset ( n = 1537 ) wore accelerometers during recess .
METHODS	Teachers ( n = 111 ) also reported on their students ' physical activity during recess .
RESULTS	A significantly higher percentage of teachers in treatment schools reported that their students engaged in an intense physical activity during recess ( p = 0.01 ) .
RESULTS	Marginally significant differences between treatment and control groups were found for the mean number of accelerometer intensity counts recorded per minute during recess ( p = 0.10 ) and the mean percentage of time spent in vigorous physical activity during recess ( p = 0.07 ) .
RESULTS	No significant differences were found for student reports about their physical activity during recess ( p = 0.92 ) .
CONCLUSIONS	Teachers in Playworks schools reported that students were more active during recess , but accelerometer and student survey measures showed either no impacts or marginally significant impacts .

###25284708
BACKGROUND	Adults with intellectual disability ( ID ) are physically very inactive .
BACKGROUND	This study will compare two approaches to increasing physical activity in adults with ID : a lifestyle physical activity ( light-moderate intensity ) approach and a structured exercise ( moderate-vigorous intensity ) approach .
BACKGROUND	The trial will compare the short-term ( 3-month ) and long-term ( 9-month ) outcomes and sustainability of each approach with a usual-care control group .
METHODS	A three-arm randomised controlled trial ( RCT ) will be conducted .
METHODS	Ninety adults with ID aged 18-55 will be randomly assigned to one of three groups : 1 ) a lifestyle physical activity group ( n = 30 ) , 2 ) a structured exercise group ( n = 30 ) , or 3 ) a usual care control group ( n = 30 ) .
METHODS	Participants in both groups will receive a 12-week intervention delivered by exercise specialists in the community with disability service staff , after which intervention will continue for 6months , delivered by disability service staff only .
METHODS	Primary outcomes are aerobic fitness , 12-hour energy expenditure , and proxy-reported everyday physical activity .
METHODS	Secondary outcomes include objectively assessed physical activity and sedentary behaviour , intervention compliance , functional walking capacity , participation in domestic activities , muscle strength , body composition , psychosocial outcomes , quality of life and health care costs .
CONCLUSIONS	The trial results will determine the effectiveness and sustainability of two approaches to increasing physical activity and exercise among adults with ID .
BACKGROUND	ISRCTN77889248 ( 18 April 2012 ) .

###25833972
BACKGROUND	Poor nutritional quality of complementary foods often limits growth .
BACKGROUND	Animal source foods , such as milk or meat , are often unaffordable .
BACKGROUND	Local affordable alternatives are needed .
OBJECTIVE	We evaluate the efficacy of 2 newly developed , rice-based complementary food products : WinFood ( WF ) with small fish and edible spiders and WinFood-Lite ( WF-L ) fortified with small fish , against 2 existing fortified corn-soy blend products , CSB + ( purely plant based ) and CSB + + ( 8 % dried skimmed milk ) .
METHODS	In total , 419 infants aged 6 mo were enrolled in this randomized , single-blinded study for 9 mo , designed primarily to assess increments in fat-free mass by a deuterium dilution technique and change in plasma ferritin and soluble transferrin receptor .
METHODS	Secondary endpoints were changes in anthropometric variables , including knee-heel length .
METHODS	Data were analyzed by the intention-to-treat approach .
RESULTS	There was no difference in fat-free mass increment in WF or WF-L compared with CSB + [ WF : +0.04 kg ( 95 % CI : -0.20 , 0.28 kg ) ; WF-L : +0.14 kg ( 95 % CI : -0.10 , 0.38 kg ) ] or CSB + + [ WF : -0.03 kg ( 95 % CI : -0.27 , 0.21 kg ) ; WF-L : +0.07 kg ( 95 % CI : -0.18 , 0.31 kg ) ] and no effect on iron status .
RESULTS	The 1.7-mm ( 95 % CI : -0.1 , 3.5 mm ) greater increase in knee-heel length in WF-L than in CSB + was not significant .
CONCLUSIONS	No difference was found between the locally produced products ( WF and WF-L ) and the CSBs .
CONCLUSIONS	Micronutrient fortification may be necessary , and small fish may be an affordable alternative to milk to improve complementary foods .
CONCLUSIONS	The dietary role of edible spiders needs to be further explored .
CONCLUSIONS	This trial was registered at controlled-trials .
CONCLUSIONS	com as ISRCTN19918531 .

###25689245
OBJECTIVE	To compare the effectiveness and safety of two glycemic control regimens in stable critical care patients receiving parenteral nutrition ( PN ) .
METHODS	Prospective , randomized open-label clinical trial .
METHODS	Eligible postoperative critical care patients in the ICU began PN on the first to the seventh day of ICU admission .
METHODS	The PN admixture included regular insulin , in doses sufficient to maintain 3 or more goal blood glucose ( BG ) levels between 110 and 180mg/dl .
METHODS	After 3 to 5days of PN containing regular insulin , patients were randomized to 3 more days of regular insulin at the same dose or 80 % of their total daily regular insulin dose provided in PN solution as glargine insulin .
METHODS	Capillary BG monitoring was performed every 6hours .
RESULTS	Twenty one patients were randomized to each treatment group .
RESULTS	Median APACHE II scores were not significantly different between the two groups within the first 24-hour of ICU admission .
RESULTS	There were no significant differences between the two groups at day 3 for mean daily dextrose ( 306.946.2 vs. 305.252.2 g ; p = 0.913 ) or insulin ( 18.38.8 vs. 19.510.0 units ; p = 0.696 ) doses .
RESULTS	The percentage of BG values in the goal ( 110-180mg / dl ) , hyperglycemic ( > 180mg/dl ) , and hypoglycemic ( < 70mg/dl ) BG levels were similar between the two groups ( 69.0 % vs. 66.7 % , p = 0.567 ; 11.9 % vs. 11.1 % , p = 0.780 ; 0 % vs. 1.6 % , p = 0.124 , respectively ) .
RESULTS	Mean daily BG levels were not significantly different between the two groups on each of the 3 study days ( day 1 : 14020 vs. 13125mg/dl , p = 0.194 ; day 2 : 13620 vs. 14018mg/dl , p = 0.498 ; day 3 : 14215 vs. 14019mg/dl ; p = 0.741 ) .
CONCLUSIONS	These data suggest that , compared with regular insulin added to PN , glargine insulin results in similar glycemic control and rates of hyperglycemia and hypoglycemia in stable critical care patients .

###24669015
BACKGROUND	Everolimus synergistically enhances taxane-induced cytotoxicity in breast cancer cells in vitro and in vivo in addition to demonstrating a direct antiproliferative activity .
BACKGROUND	We aim to determine pharmacodynamics changes and response of adding everolimus to standard neoadjuvant chemotherapy in triple-negative breast cancer ( TNBC ) .
METHODS	Phase II study in patients with primary TNBC randomized to T-FEC ( paclitaxel 80 mg/m ( 2 ) i.v. weekly for 12 weeks , followed by 5-fluorouracil 500 mg/m ( 2 ) , epirubicin 100 mg/m ( 2 ) , and cyclophosphamide 500 mg/m ( 2 ) every 3 weeks for four cycles ) versus TR-FEC ( paclitaxel 80 mg/m ( 2 ) i.v. and everolimus 30 mg PO weekly for 12 weeks , followed by FEC ) .
METHODS	Tumor samples were collected to assess molecular changes in the PI3K/AKT/mTOR pathway , at baseline , 48 h , 12 weeks , and at surgery by reverse phase protein arrays ( RPPA ) .
METHODS	Clinical end points included 12-week clinical response rate ( 12-week RR ) , pathological complete response ( pCR ) , and toxicity .
RESULTS	Sixty-two patients were registered , and 50 were randomized , 27 received T-FEC , and 23 received TR-FEC .
RESULTS	Median age was 48 ( range 31-75 ) .
RESULTS	There was downregulation of the mTOR pathway at 48 h in the TR-FEC arm .
RESULTS	Twelve-week RR by ultrasound were 29.6 % versus 47.8 % , ( P = 0.075 ) , and pCR were 25.9 % versus 30.4 % ( P = 0.76 ) for T-FEC and TR-FEC , respectively .
RESULTS	mTOR downregulation at 48 h did not correlate with 12-week RR in the TR-FEC group ( P = 0.58 ) .
RESULTS	Main NCI grade 3/4 toxicities included anemia , neutropenia , rash/desquamation , and vomiting in both arms .
RESULTS	There was one case of grade 3 pneumonitis in the TR-FEC arm .
RESULTS	No grade 3/4 stomatitis occurred .
CONCLUSIONS	The addition of everolimus to paclitaxel was well tolerated .
CONCLUSIONS	Everolimus downregulated mTOR signaling but downregulation of mTOR at 48 h did not correlate with 12-week RR in the TR-FEC group .
BACKGROUND	NCT00499603 .

###24827696
BACKGROUND	Pain after total knee arthroplasty ( TKA ) is usually severe .
BACKGROUND	Recently , the usefulness of local periarticular injection analgesia ( PAI ) and peripheral nerve block ( PNB ) has been reported .
BACKGROUND	We report a prospective blinded randomized trial of PAI versus PNB in patients undergoing primary TKA , in accordance with the CONSORT statement 2010 .
METHODS	A total of 210 patients undergoing TKA under spinal anesthesia were randomized to receive PNB group or PAI group .
METHODS	In the PNB group , femoral nerve block and sciatic nerve block were performed .
METHODS	In the PAI group , a special mixture containing ropivacaine , saline , epinephrine , morphine hydrochloride , and dexamethasone was injected into the periarticular soft tissue .
METHODS	Pain intensity at rest was assessed using a numerical rating scale ( NRS : 0-10 ) after surgery .
METHODS	Use of a diclofenac sodium suppository ( 25mg ) was allowed for all patients at any time after surgery , and the diclofenac sodium suppository usage was assessed .
METHODS	The NRS for patient satisfaction at 48 hours after surgery was examined .
RESULTS	The average NRS for pain at rest up to 48 hours after surgery was low in both groups .
RESULTS	Within 48 hours after surgery , the diclofenac sodium suppository usage was similar in both groups .
RESULTS	There were no significant differences in the NRS for patient satisfaction in both groups .
CONCLUSIONS	The analgesic effects of PAI and PNB are similar .
CONCLUSIONS	PAI may be considered superior to PNB because it is easier to perform .
METHODS	Therapeutic Level 1 .

###24400643
BACKGROUND	Most patients with heart failure are diagnosed and managed in primary care , however , underdiagnosis and undertreatment are common .
BACKGROUND	We assessed whether implementation of a diagnostic-therapeutic strategy improves functionality , health-related quality of life , and uptake of heart failure medication in primary care .
METHODS	A selective screening study followed by a single-blind cluster randomized trial in primary care .
METHODS	The study population consists of patients aged 65 years or over who presented themselves to the general practitioner in the previous 12 months with shortness of breath on exertion .
METHODS	Patients already known with established heart failure , confirmed by echocardiography , are excluded .
METHODS	Diagnostic investigations include history taking , physical examination , electrocardiography , and serum N-terminal pro B-type natriuretic peptide levels .
METHODS	Only participants with an abnormal electrocardiogram or an N-terminal pro B-type natriuretic peptide level exceeding the exclusionary cutpoint for non-acute onset heart failure ( > 15 pmol/L ( 125 pg/ml ) ) will undergo open-access echocardiography .
METHODS	The diagnosis of heart failure ( with reduced or preserved ejection fraction ) is established by an expert panel consisting of two cardiologists and a general practitioner , according to the criteria of the European Society of Cardiology guidelines.Patients with newly established heart failure are allocated to either the ` care as usual ' group or the ` intervention ' group .
METHODS	Randomization is at the level of the general practitioner .
METHODS	In the intervention group general practitioners receive a single half-day training in heart failure management and the use of a structured up-titration scheme .
METHODS	All participants fill out quality of life questionnaires at baseline and after six months of follow-up .
METHODS	A six-minute walking test will be performed in patients with heart failure .
METHODS	Information on medication and hospitalization rates is extracted from the electronic medical files of the general practitioners .
CONCLUSIONS	This study will provide information on the prevalence of unrecognized heart failure in elderly with shortness of breath on exertion , and the randomized comparison will reveal whether management based on a half-day training of general practitioners in the practical application of an up-titration scheme results in improvements in functionality , health-related quality of life , and uptake of heart failure medication in heart failure patients compared to care as usual .
BACKGROUND	ClinicalTrials.gov NCT01202006 .

###24378032
OBJECTIVE	To determine the effects of constant exposure to cattle persistently infected ( PI ) with bovine viral diarrhea virus ( BVDV ) on health and performance of feedlot cattle .
METHODS	3 controlled trials .
METHODS	Crossbred feedlot cattle ( trial 1 , n = 184 ; trial 2 , 138 ; trial 3 , 138 ) .
METHODS	Weaned calves were or were not vaccinated against BVDV at feedlot arrival ( trial 1 ) or 2 ( trial 2 ) or 3 ( trial 3 ) weeks before feedlot arrival .
METHODS	During trial 1 , half of the calves were commingled with PI cattle throughout the feeding period .
METHODS	During trial 2 , 63 calves were exposed to PI cattle before weaning and all calves were exposed to PI cattle throughout the feeding period .
METHODS	During trial 3 , all study calves were exposed to PI cattle throughout the feeding period .
METHODS	Morbidity and mortality rates and average daily gain ( ADG ) data were analyzed .
RESULTS	During trial 1 , calves maintained with PI cattle had a higher morbidity rate regardless of BVDV vaccination than did calves not exposed to PI cattle ; however , for calves maintained with PI cattle , the morbidity rate for those vaccinated against BVDV was less than that for those not vaccinated against BVDV .
RESULTS	During trial 2 , calves exposed to PI cattle before weaning or vaccinated against BVDV had lower morbidity and mortality rates and increased ADG , compared with those for calves not exposed to PI cattle before weaning or vaccinated against BVDV .
RESULTS	During trial 3 , health and performance did not vary between calves that were and were not vaccinated against BVDV .
CONCLUSIONS	Exposure of cattle to BVDV naturally or through vaccination before or at feedlot arrival mitigated the negative effects of constant exposure to PI cattle .

###25023573
BACKGROUND	The efficacy of a slow-release insecticidal and repellent collar containing 10 % imidacloprid and 4.5 % flumethrin ( Seresto , Bayer Animal Health ) in preventing Leishmania infantum infection was evaluated in a large population of dogs living in a hyper-endemic area of Sicily ( Italy ) .
METHODS	A total of 219 dogs , negative for L. infantum were enrolled in a multicentre , controlled study .
METHODS	Dogs were divided into two homogeneous groups , defined as G1 ( n = 102 ) and G2 ( n = 117 ) .
METHODS	Before the start of the sand fly season , dogs in G1 were treated with the collar while animals in G2 were left untreated , serving as negative controls .
METHODS	Dogs were serially sampled on day D90 , D180 , D210 and D300 in order to assess Leishmania infection by IFAT , PCR on skin ( D210-D300 ) and bone marrow ( D300 ) and cytology on bone marrow aspirate ( D300 ) .
RESULTS	Three dogs ( 2.9 % ) in G1 and 41 ( 40.2 % ) in G2 became positive for L. infantum in at least one of the diagnostic tests employed in the study .
RESULTS	The number of seropositive dogs in G2 increased in the course of the study from 15 ( D90 ) to 41 ( D300 ) , with some of them also positive in other diagnostic tests .
RESULTS	Eight ( 19.6 % ) of the seropositive dogs in G2 showed an increase in antibody titers ranging from 1:160 to 1:1,280 .
RESULTS	At the last follow-up , some of dogs in G2 displayed overt clinical signs suggestive of leishmaniosis .
RESULTS	The mean incidence density rate at the final follow-up was 4.0 % for G1 and 60.7 % for G2 , leading to a mean efficacy of the collar in protecting dogs at both sites of 93.4 % .
CONCLUSIONS	The slow-release collar tested in this study was shown to be safe and highly effective in preventing L. infantum infection in a large population of dogs .
CONCLUSIONS	Protection conferred by a single collar ( up to eight months ) spanned an entire sand fly season in a hyper-endemic area of southern Italy .
CONCLUSIONS	The regular use of collars , at least during the sand fly season , may represent a reliable and sustainable strategy for the prevention of leishmaniosis in dogs living in or travelling to an endemic area .

###24815501
BACKGROUND	Meaningful delays occurred in the Interventional Management of Stroke ( IMS ) III trial .
BACKGROUND	Analysis of the work flow will identify factors contributing to the in-hospital delays .
RESULTS	In the endovascular arm of the IMS III trial , the following time intervals were calculated : stroke onset to emergency department arrival ; emergency department to computed tomography ( CT ) ; CT to intravenous tissue plasminogen activator start ; intravenous tissue plasminogen activator start to randomization ; randomization to groin puncture ; groin puncture to thrombus identification ; thrombus identification to start of endovascular therapy ; and start of endovascular therapy to reperfusion .
RESULTS	The effects of enrollment time , CT angiography use , interhospital transfers , and intubation on work flow were evaluated .
RESULTS	Delays occurred notably in the time intervals from intravenous tissue plasminogen activator initiation to groin puncture ( median 84 minutes ) and start of endovascular therapy to reperfusion ( median 85 minutes ) .
RESULTS	The CT to groin puncture time was significantly shorter during working hours than after .
RESULTS	Times from emergency department to reperfusion and groin puncture to reperfusion decreased over the trial period .
RESULTS	Patients with CT angiography had shorter emergency department to reperfusion and onset to reperfusion times .
RESULTS	Transfer of patients resulted in a longer onset to reperfusion time compared with those treated in the same center .
RESULTS	Age , sex , National Institutes of Health Stroke Scale score , and intubation did not affect delays .
CONCLUSIONS	Important delays were identified before reperfusion in the IMS III trial .
CONCLUSIONS	Delays decreased as the trial progressed .
CONCLUSIONS	Use of CT angiography and endovascular treatment in the same center were associated with time savings .
CONCLUSIONS	These data may help in optimizing work flow in current and future endovascular trials .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00359424 .

###26091202
BACKGROUND	Dosages of vitamin D necessary to prevent or treat vitamin D deficiency in children remain to be clarified .
OBJECTIVE	To determine the effects of vitamin D3 1000 IU/d on serum 25-hydroxyvitamin D [ 25 ( OH ) D ] , PTH , and markers of bone turnover ( osteocalcin and collagen type 1 cross-linked C-telopeptide ) in black children and white children , and to explore whether there is a threshold level of 25 ( OH ) D associated with maximal suppression of serum PTH concentration .
METHODS	Healthy 8 - to 14-year-old Pittsburgh-area black ( n = 84 ) and white ( n = 73 ) children not receiving vitamin supplements , enrolled from October through March from 2008 through 2011 , were randomized to vitamin D3 1000 IU or placebo daily for 6 months .
RESULTS	The mean baseline concentration of 25 ( OH ) D was < 20 ng/mL in both the vitamin D-supplemented group and the placebo group ( 19.8 7.6 and 18.8 6.9 ng/mL , respectively ) .
RESULTS	The mean concentration was higher in the supplemented group than in the placebo group at 2 months ( 26.4 8.1 vs 18.9 8.1 ng/mL ; P < .0001 ) and also at 6 months ( 26.7 7.6 vs 22.4 7.3 ; P = .003 ) , after adjusting for baseline 25 ( OH ) D , race , gender , pubertal status , dietary vitamin D intake , body mass index , and sunlight exposure .
RESULTS	Increases were only significant in black children , when examined by race .
RESULTS	The association between 25 ( OH ) D and PTH concentrations was inverse and linear , without evidence of a plateau .
RESULTS	Overall , vitamin D supplementation had no effect on PTH and bone turnover .
CONCLUSIONS	Vitamin D3 supplementation with 1000 IU/d in children with mean baseline 25 ( OH ) D concentration < 20 ng/mL effectively raised their mean 25 ( OH ) D concentration to 20 ng/mL but failed to reach 30 ng/mL .
CONCLUSIONS	Vitamin D supplementation had no effect on PTH concentrations .

###24623067
OBJECTIVE	Vitamin D may be a regulator of skeletal muscle function , although human trials investigating this hypothesis are limited to predominantly elderly populations .
OBJECTIVE	We aimed to assess the effect of oral vitamin D3 in healthy young males upon skeletal muscle function .
METHODS	Participants ( n = 29 ) received an oral dose of 10,000 IU day ( -1 ) vitamin D3 ( VITD ) or a visually identical placebo ( PLB ) for 3 months .
METHODS	Serum 25 [ OH ] D and intact parathyroid hormone ( iPTH ) were measured at baseline and at week 4 , 8 and 12 .
METHODS	Muscle function was assessed in n = 22 participants by isokinetic dynamometry and percutaneous isometric electromyostimulation at baseline and at week 6 and 12 .
RESULTS	Baseline mean total serum 25 [ OH ] D was 40 17 and 41 20 nmol L ( -1 ) for PLB and VITD , respectively .
RESULTS	VITD showed a significant improvement in total 25 [ OH ] D at week 4 ( 150 31 nmol L ( -1 ) ) that remained elevated throughout the trial ( P < 0.005 ) .
RESULTS	Contrastingly , PLB showed a significant decrease in 25 [ OH ] D at week 12 ( 25 15 nmol L ( -1 ) ) compared with baseline .
RESULTS	Despite marked increases in total serum 25 [ OH ] D in VITD and a decrease in PLB , there were no significant changes in any of the muscle function outcome measures at week 6 or 12 for either group ( P > 0.05 ) .
CONCLUSIONS	Elevating total serum 25 [ OH ] D to concentrations > 120 nmol L ( -1 ) has no effect on skeletal muscle function .
CONCLUSIONS	We postulate that skeletal muscle function is only perturbed in conditions of severe deficiency ( < 12.5 nmol L ( -1 ) ) .

###25459393
BACKGROUND	The addition of bevacizumab to paclitaxel or capecitabine has demonstrated improved progression-free survival ( PFS ) and objective response rate ( ORR ) as compared with chemotherapy alone in patients with HER2-negative locally recurrent or metastatic breast cancer ( LR/MBC ) .
BACKGROUND	We evaluated the efficacy and safety of first-line therapy of paclitaxel and bevacizumab with or without capecitabine in patients with HER2-negative LR/MBC .
METHODS	In this multicentre , open-label , randomised phase II trial , women with HER2-negative LR/MBC were randomly assigned in a 1:1 ratio to paclitaxel ( 90 mg/m2 intravenously [ IV ] on days 1 , 8 , and 15 ) and bevacizumab ( 10 mg/kg IV on days 1 and 15 ) every 4 weeks for six cycles , followed by bevacizumab ( 15 mg/kg IV on day 1 ) every 3 weeks ( AT ) or to paclitaxel ( 90 mg/m2 IV on days 1 and 8 ) , bevacizumab ( 15 mg/kg IV on day 1 ) and capecitabine ( 825 mg/m2 orally twice daily on days 114 ) every 3 weeks for eight cycles , followed by bevacizumab and capecitabine at the same doses every 3 weeks ( ATX ) .
METHODS	The primary end-point was investigator-assessed PFS .
METHODS	Secondary end-points included ORR , duration of response , overall survival ( OS ) and safety .
METHODS	Exploratory analyses were conducted to evaluate the impact of capecitabine on OS and to validate a novel prognostic model .
METHODS	This trial is registered with EudraCT , number 2006-006058-83 .
RESULTS	Median PFS was significantly longer in ATX as compared with AT ( 11.2 months versus 8.4 months ; stratified hazard ratio ( HR ) , 0.52 ; 95 % confidence interval ( CI ) , 0.410.67 ; p < 0.0001 ) .
RESULTS	The ORR in ATX patients with measurable disease ( n = 268 ) was higher than that in AT ( 69 % versus 51 % ; p = 0.01 ) .
RESULTS	The median duration of response was 6.8 versus 5.4 months for , respectively , ATX and AT ( p < 0.0001 ) .
RESULTS	Median OS was 24.2 months for ATX and 23.1 months for AT ( p = 0.53 ) .
RESULTS	The increased rate of grade 34 adverse events related to the addition of capecitabine , being hand-foot syndrome ( 34 % versus 0 % for AT ) and neutropenia ( 20 % versus 12 % for AT ) , generally did not preclude continuation of treatment .
RESULTS	Exploratory analyses indicated that ( 1 ) patients receiving capecitabine at some line for treatment have significantly improved OS and ( 2 ) a prognostic model can classify patients into three risk groups associated with OS .
CONCLUSIONS	In patients with HER2-negative LR/MBC , addition of capecitabine to paclitaxel and bevacizumab significantly improved PFS , ORR and response duration .
CONCLUSIONS	This combination was reasonably well tolerated and may be considered of use as first-line treatment in rapidly progressive disease .
BACKGROUND	F. Hoffmann-La Roche Ltd , the Netherlands .

###25632085
OBJECTIVE	We investigated the determinants and clinical correlations of MRI-detected brain volume loss ( BVL ) among patients with relapsing-remitting multiple sclerosis from the phase 3 trials of fingolimod : FREEDOMS , FREEDOMS II , and TRANSFORMS .
METHODS	Post hoc analyses were conducted in the intent-to-treat populations from each trial and in a combined dataset of 3,635 patients from the trials and their extensions .
METHODS	The relationship between brain volume changes and demographic , clinical , and MRI parameters was studied in pairwise correlations ( Pearson ) and in multiple regression models .
METHODS	The relative frequency of confirmed disability progression was evaluated in the combined dataset by strata of concurrent BVL at up to 4 years .
RESULTS	Increasing age , disease duration , T2 lesion volume , T1-hypointense lesion volume , and disability were associated with reduced brain volume ( p < 0.001 , all ) .
RESULTS	The strongest individual baseline predictors of on-study BVL were T2 lesion volume , gadolinium-enhancing lesion count , and T1-hypointense lesion volume ( p < 0.01 , all ) .
RESULTS	During each study , BVL correlated most strongly with cumulative gadolinium-enhancing lesion count , new/enlarged T2 lesion count ( p < 0.001 , both ) , and number of confirmed on-study relapses ( p < 0.01 ) .
RESULTS	Over 4 years in the combined dataset ( mean exposure to study drug , 2.4 years ) , confirmed disability progression was most frequent in patients with greatest BVL .
CONCLUSIONS	Rate of BVL in patients during the fingolimod trials correlated with disease severity at baseline and new disease activity on study , and was associated with worsening disability .

###26437535
OBJECTIVE	To study the changes in cortisol levels during and after cardiac surgery after an inductive dose of either etomidate or thiopentone and their consequences .
METHODS	A prospective , randomized , double-blinded study was conducted in 26 patients undergoing elective cardiac surgery .
METHODS	They received either etomidate or thiopentone for induction .
METHODS	Serum cortisol levels were measured preoperatively , and then at 2 - , 4 - , 8 - , and 24-hour All of the patients received standard anesthesia and surgery .
METHODS	The data also included patients perioperative management and outcome .
RESULTS	There is no difference in patients ' characteristics .
RESULTS	The baseline plasma morning cortisols in the two groups were comparable ( 11.7 7.5 mcg/dL in etomidate group vs. 12.0 8.2 mcg/dL in thiopentone group ) .
RESULTS	In both groups , during surgery , the cortisol levels rose to higher levels and reached peak levels at four to eight hours and related to surgical stress .
RESULTS	At all times , the etomidate group had lower cortisol levels but only at 8-hour the etomidate group had significantly lower cortisol level ( 39.9 14.2 vs. 65.9 20.0 mcg/dL ) .
RESULTS	At 24 hours , in both groups , cortisol levels were lower than at 8-hour but did not return to normal baseline levels .
RESULTS	There were no differences in the dose of inotropic use and ICU stay .
RESULTS	However surprisingly the etomidate group had shorter hospital stay .
CONCLUSIONS	A single dose of etomidate usedfor induction in elective cardiac patients can partially and reversibly inhibit of the cortisol synthesis for , at least , 24 hours , but its association with any hemodynamic consequences can not be concluded .
BACKGROUND	ClinicalTrials.gov as NCT01495949 .

###24796044
OBJECTIVE	To observe improved effects of Jingjin acupuncture on fine activity of hemiplegic hand in recovery period of stroke .
METHODS	Fifty cases were randomly divided into an observation group and a control group , 25 cases in each one .
METHODS	Regular western medicine treatment , rehabilitation training and regular acupuncture ( in which Shuigou ( GV 26 ) , Baihui ( GV 20 ) , Neiguan ( PC 6 ) , etc. were selected ) were applied in both groups .
METHODS	Additionally , muscles in palm side of affected hand , dorsal metacarpophalangeal joints and proximal interphalangeal joints were treated with acupuncture in the observation group , once every other day and electroacupuncture was applied when arrival of qi was acquired .
METHODS	Baxie ( EX-UE 9 ) in the affected hand were needled in the control group , and electroacupuncture was added when arrival of qi was acquired .
METHODS	Ten days of treatment was considered a treatment course , and after two courses Lindmark score , Brunnstrom movement function grade , joint range of hand and Barthel index ( BI ) were observed in two groups .
RESULTS	Compared before the treatment , the Lindmark score in two groups were both improved after the treatment ( both P < 0.01 ) .
RESULTS	Compared with the control group , the motor coordination ability , sensory function and total score of Lindmark in observation group were obviously improved ( differences before and after treatment : 8.24 + / - 3.07 vs 6.84 + / - 2.43 , 3.52 + / - 2.33 vs 2.16 + / - 2.12 , 11.76 + / - 3.55 vs 9.00 + / - 3.62 , all P < 0.05 ) .
RESULTS	The Brunnstrom movement function grade was significantly improved in both groups after treatment ( both P < 0.01 ) , which was more obvious in the observation group ( P < 0.05 ) .
RESULTS	The joint range of hemiplegic hand was improved in both groups after treatment ( both P < 0.01 ) , which was more obvious in the observation group [ differences before and after treatment : ( 25.35 + / - 10.91 ) degrees vs ( 18.65 + / - 7.86 ) degrees , p < 0.05 ] .
RESULTS	The score of BI was also significantly improved after treatment in two groups ( both P < 0.01 ) .
CONCLUSIONS	The Jingjin acupuncture could effectively improve fine activity of hemiplegic hand in recovery period of stroke prove daily life ability .

###25339485
OBJECTIVE	This study aimed to explore the possible mechanism of spironolactone in reduction of atrial fibrosis in elderly patients with atrial fibrillation .
METHODS	67 patients with atrial fibrillation and 30 matching patients with sinus rhythm were included into this study , in which the former patients were randomly divided into the conventional treatment group ( 33 cases ) and spironolactone ( 20 mg/d ) treatment group ( 34 cases ) .
METHODS	They underwent follow-ups for 6 months .
METHODS	The levels of serum aldosterone , PICP ( propeptide of type I procollagen ) and CITP ( carboxy-terminal cross-linking telopeptide of type I collagen ) were determined before and after treatment .
RESULTS	The concentrations of serum PICP , CITP and aldosterone and left atrial size in the atrial fibrillation group were all higher than the control group ( t values were 7.982 , 5.950 , 9.309 , 9.050 , respectively , p < 0.01 ) , with a significant statistical difference .
RESULTS	The concentrations of serum PICP and aldosterone were both positively corelated to the left atrial size in the atrial fibrillation group ( r values were 0.302 and 0.369 , respectively ) .
RESULTS	The levels of serum aldosterone and PICP after treatment were both decreased compared to those before treatment in the spironolactone treatment group and conventional treatment group , especially in the spironolactone treatment group .
RESULTS	There were statistical differences in the levels of serum aldosterone and PICP after treatment between the two groups ( t values were 2.872 and 3.054 , respectively , p < 0.01 ) .
CONCLUSIONS	Spironolactone could reduce the levels of serum aldosterone and PICP in patients with atrial fibrillation , so as to reduce the atrial fibrosis and delay the occurrence and development of atrial fibrillation .

###24595800
BACKGROUND	The presence of tumor cells at the margins of breast lumpectomy specimens is associated with an increased risk of ipsilateral tumor recurrence .
BACKGROUND	Twenty to 30 % of patients undergoing breast-conserving surgery require second procedures to achieve negative margins .
BACKGROUND	This study evaluated the adjunctive use of the MarginProbe device ( Dune Medical Devices Ltd , Caesarea , Israel ) in providing real-time intraoperative assessment of lumpectomy margins .
METHODS	This multicenter randomized trial enrolled patients with nonpalpable breast malignancies .
METHODS	The study evaluated MarginProbe use in addition to standard intraoperative methods for margin assessment .
METHODS	After specimen removal and inspection , patients were randomized to device or control arms .
METHODS	In the device arm , MarginProbe was used to examine the main lumpectomy specimens and direct additional excision of positive margins .
METHODS	Intraoperative imaging was used in both arms ; no intraoperative pathology assessment was permitted .
RESULTS	In total , 596 patients were enrolled .
RESULTS	False-negative rates were 24.8 and 66.1 % and false-positive rates were 53.6 and 16.6 % in the device and control arms , respectively .
RESULTS	All positive margins on positive main specimens were resected in 62 % ( 101 of 163 ) of cases in the device arm , versus 22 % ( 33 of 147 ) in the control arm ( p < 0.001 ) .
RESULTS	A total of 19.8 % ( 59 of 298 ) of patients in the device arm underwent a reexcision procedure compared with 25.8 % ( 77 of 298 ) in the control arm ( 6 % absolute , 23 % relative reduction ) .
RESULTS	The difference in tissue volume removed was not significant .
CONCLUSIONS	Adjunctive use of the MarginProbe device during breast-conserving surgery improved surgeons ' ability to identify and resect positive lumpectomy margins in the absence of intraoperative pathology assessment , reducing the number of patients requiring reexcision .
CONCLUSIONS	MarginProbe may aid performance of breast-conserving surgery by reducing the burden of reexcision procedures for patients and the health care system .

###25597555
OBJECTIVE	To determine the prevalence of impaired olfaction in individuals presenting for cardiac surgery and the independent association between impaired olfaction and postoperative delirium and cognitive decline .
METHODS	Nested prospective cohort study .
METHODS	Academic hospital .
METHODS	Individuals undergoing coronary artery bypass , valve surgery , or both ( n = 165 ) .
METHODS	Olfaction was measured using the Brief Smell Identification Test , with impaired olfaction defined as an olfactory score below the fifth percentile of normative data .
METHODS	Delirium was assessed using a validated chart review method .
METHODS	Cognitive performance was assessed using a neuropsychological testing battery at baseline and 4 to 6 weeks after surgery .
RESULTS	Impaired olfaction was identified in 54 of 165 participants ( 33 % ) before surgery .
RESULTS	Impaired olfaction was associated with greater adjusted risk of postoperative delirium ( relative risk = 1.90 , 95 % confidence interval = 1.17-3 .09 , P = .009 ) .
RESULTS	There was no association between impaired olfaction and change in composite cognitive score in the overall study population .
CONCLUSIONS	Impaired olfaction is prevalent in individuals undergoing cardiac surgery and is associated with greater adjusted risk of postoperative delirium but not cognitive decline .
CONCLUSIONS	Impaired olfaction may identify unrecognized vulnerability to postoperative delirium in individuals undergoing cardiac surgery .

###25433628
BACKGROUND	WHO recommends daily co-trimoxazole for children born to HIV-infected mothers from 6 weeks of age until breastfeeding cessation and exclusion of HIV infection .
BACKGROUND	We have previously reported on the effectiveness of continuation of co-trimoxazole prophylaxis up to age 2 years in these children .
BACKGROUND	We assessed the protective efficacy and safety of prolonging co-trimoxazole prophylaxis until age 4 years in HIV-exposed children .
METHODS	We undertook an open-label randomised controlled trial alongside two observational cohorts in eastern Uganda , an area with high HIV prevalence , malaria transmission intensity , and antifolate resistance .
METHODS	We enrolled HIV-exposed infants between 6 weeks and 9 months of age and prescribed them daily co-trimoxazole until breastfeeding cessation and HIV-status confirmation .
METHODS	At the end of breastfeeding , children who remained HIV-uninfected were randomly assigned ( 1:1 ) to discontinue co-trimoxazole or to continue taking it up to age 2 years .
METHODS	At age 2 years , children who continued co-trimoxazole prophylaxis were randomly assigned ( 1:1 ) to discontinue or continue prophylaxis from age 2 years to age 4 years .
METHODS	The primary outcome was incidence of malaria ( defined as the number of treatments for new episodes of malaria diagnosed with positive thick smear ) at age 4 years .
METHODS	For additional comparisons , we observed 48 HIV-infected children who took continuous co-trimoxazole prophylaxis and 100 HIV-unexposed uninfected children who never received prophylaxis .
METHODS	We measured grade 3 and 4 serious adverse events and hospital admissions .
METHODS	All children were followed up to age 5 years and all analyses were by intention to treat .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00527800 .
RESULTS	203 HIV-exposed infants were enrolled between Aug 10 , 2007 , and March 28 , 2008 .
RESULTS	After breastfeeding ended , 185 children were not infected with HIV and were randomly assigned to stop ( n = 87 ) or continue ( n = 98 ) co-trimoxazole up to age 2 years .
RESULTS	At age 2 years , 91 HIV-exposed children who had remained on co-trimoxazole prophylaxis were randomly assigned to discontinue ( n = 46 ) or continue ( n = 45 ) co-trimoxazole from age 2 years to age 4 years .
RESULTS	We recorded 243 malaria episodes ( 291 per person-years ) in the 45 HIV-exposed children assigned to continue co-trimoxazole until age 4 years compared with 503 episodes ( 560 per person-years ) in the 46 children assigned to stop co-trimoxazole at age 2 years ( incidence rate ratio 053 , 95 % CI 039-071 ; p < 00001 ) .
RESULTS	There was no evidence of malaria incidence rebound in the year after discontinuation of co-trimoxazole in the HIV-exposed children who stopped co-trimoxazole at age 2 years , but incidence increased significantly in HIV-exposed children who stopped co-trimoxazole at age 4 years ( odds ratio 178 , 95 % CI 119-266 ; p = 0005 ) .
RESULTS	Incidence of grade 3 or 4 serious adverse events , hospital admissions , or deaths did not significantly differ between HIV-exposed , HIV-unexposed , and HIV-infected children .

###24563440
OBJECTIVE	We aimed to determine the relationship between blood lactate , carboxy-hemoglobin ( COHb ) levels and the severity of clinical findings in patients with CO poisoning .
METHODS	Patients over 18 years old and of both gender who were admitted to Emergency Department with the diagnosis of CO poisoning between 10.02.2008 and 17.03.2011 were enrolled in this study .
METHODS	Detailed physical examination of each patient was performed , patients and their relatives were informed about the study and written consents were noted .
METHODS	The levels of consciousness , physical examination findings , electrocardiographic findings , Glasgow Coma Scale ( GCS ) scores , laboratory results ( lactate , COHb , CK-MB , Troponin-I levels ) and applied treatments [ normobaric oxygen therapy ( NBOT ) , hyperbaric oxygen therapy ( HBOT ) ] were recorded to standart data entry form for each patient .
METHODS	`` SPSS for Windows version 18 '' package program was used for statistical analysis of the data .
RESULTS	Total 201 patients were included in this study .
RESULTS	Thirty five patients ( 17.4 % ) received HBOT and lactate ; COHb , CKMB , Troponin-I levels of this group were higher than the other patients .
RESULTS	Lactate and COHb levels were statistically significantly higher in patients with GCS < 15 than the ones with GCS = 15 ( p < 0.01 ) .
RESULTS	The patients whose both Troponin-I and CK-MB levels increased have higher lactate levels ( p = 0.038 ) , but COHb levels of these patients did not change ( p = 0.495 ) .
CONCLUSIONS	According to our study , blood lactate and COHb levels were both correlated with the changes of consciousness in CO poisoning .
CONCLUSIONS	Blood lactate levels together with COHb in defining indications for HBO treatment might be suggested .

###24623718
OBJECTIVE	To evaluate ixekizumab , an anti-interleukin-17A ( anti-IL-17A ) monoclonal antibody , in 2 populations of rheumatoid arthritis ( RA ) patients : biologics-naive patients and patients with an inadequate response to tumor necrosis factor ( TNF ) inhibitors .
METHODS	In this phase II , randomized , double-blind study , placebo or ixekizumab was administered subcutaneously to 260 biologics-naive patients and 188 patients with an inadequate response to TNF inhibitors at weeks 0 , 1 , 2 , 4 , 6 , 8 , and 10 with concomitant disease-modifying antirheumatic drugs .
METHODS	The primary objective was to determine the dose-response relationship of ixekizumab as measured by the proportion of biologics-naive patients meeting the American College of Rheumatology 20 % improvement criteria ( ACR20 ) at week 12 .
RESULTS	Using a logistic regression model defined a priori , a statistically significant dose-response relationship as measured by ACR20 response rates at week 12 was detected in biologics-naive patients ( P = 0.031 ) .
RESULTS	For patients with an inadequate response to TNF inhibitors , ACR20 responses at week 12 were significantly better with ixekizumab than placebo ( P < 0.05 ) .
RESULTS	Decreases in the Disease Activity Score in 28 joints using the C-reactive protein level ( DAS28-CRP ) , Clinical Disease Activity Index ( CDAI ) , and CRP level from baseline were observed at week 12 in the ixekizumab groups in both populations ( P < 0.05 versus placebo ) .
RESULTS	Onset of action was rapid in some dose groups in both populations , with improvements in the ACR20 , DAS28-CRP , CRP levels , and CDAI observed by day 3 ( P < 0.05 ) .
RESULTS	Adverse events occurred with similar frequencies overall in the ixekizumab and placebo groups .
RESULTS	Infections were more frequent with ixekizumab than placebo ( biologics-naive 25 % versus 19 % ; inadequate responders to TNF inhibitors 27 % versus 25 % ) .
RESULTS	No mycobacterial or invasive fungal infections were reported .
CONCLUSIONS	Ixekizumab improved RA signs and symptoms in RA patients who were either naive to biologics treatment or had an inadequate response to TNF inhibitors .
CONCLUSIONS	The safety profile was similar to that of other biologic agents , with no unexpected safety concerns .

###26054140
OBJECTIVE	Io compare the difference on the clinical efficacy in treatment of chronic nephritis albuminuria between acupuncture and moxibustion at `` Xiasanhuang '' , DONG 's extra points and benazepril hydrochloride so as to provide the effective therapeutic method for the treatment of chronic nephritis albuminuria .
OBJECTIVE	Methods One hundred and six cases of nephritis albuminuria were randomized into an acupuncture and moxibustion group and a western medication group , 53 cases in each one .
OBJECTIVE	In the acupuncture and moxibustion group , acupuncture and moxibustion were applied to `` Xiasanhuang '' ( Tianhuang fuxue namely `` shenguan '' , `` Dihuang '' , `` Renhuang '' ) , once a day , the interval of 2 days once every 10 treatments .
OBJECTIVE	In the western medication group , benazepril hydrochloride was prescribed for oral administration , 5 to 10 mg each time , once a day .
OBJECTIVE	The treatment of 2 months made , one session in the two groups .
OBJECTIVE	After 1 session treatment , the clinical efficacy , red blood cell count ( RBC ) of urinary sediment , 24 h urine protein quantitation and creatinine clearance rate ( Ccr ) before and after treatment were observed in the two groups .
RESULTS	The total effective rate was 84.9 % ( 45/53 ) in the acupuncture and moxibustion group , superior to 52.8 % ( 28/53 ) in the western medication group ( P < 0.01 ) .
RESULTS	After treatment , RBC of urinary sediment and 24 h urine protein quantitation were reduced as compared with those before treatment ( P < 0.01 , P < 0.05 ) , and the results in the acupuncture and moxibustion group were lower than those in the western medication group ( P < 0.05 , P < 0.01 ) .
RESULTS	After treatment , Ccr in the acupuncture and moxibustion group was higher than that before treatment ( P < 0.05 ) and higher than that in the western medication group ( P < 0.05 ) .
RESULTS	Ccr was not different significantly before and after treatment in the western medication group ( P > 0.05 ) .
CONCLUSIONS	Acupuncture and moxibustion at DONG 's extra points ( Xiasanhuang ) reduce proteinuria and improve kidney , function in patients of chronic nephritis and the efficacy is better than that with benazepril hydrochloride .

###24898301
OBJECTIVE	Depression is a common comorbidity of diabetes , undesirably affecting patients ' physical and mental functioning .
OBJECTIVE	Psychological interventions are effective treatments for depression in the general population as well as in patients with a chronic disease .
OBJECTIVE	The aim of this study was to assess the efficacy of individual mindfulness-based cognitive therapy ( MBCT ) and individual cognitive behavior therapy ( CBT ) in comparison with a waiting-list control condition for treating depressive symptoms in adults with type 1 or type 2 diabetes .
METHODS	In this randomized controlled trial , 94 outpatients with diabetes and comorbid depressive symptoms ( i.e. , Beck Depression Inventory-II [ BDI-II ] 14 ) were randomized to MBCT ( n = 31 ) , CBT ( n = 32 ) , or waiting list ( n = 31 ) .
METHODS	All participants completed written questionnaires and interviews at pre - and postmeasurement ( 3 months later ) .
METHODS	Primary outcome measure was severity of depressive symptoms ( BDI-II and Toronto Hamilton Depression Rating Scale ) .
METHODS	Anxiety ( Generalized Anxiety Disorder 7 ) , well-being ( Well-Being Index ) , diabetes-related distress ( Problem Areas In Diabetes ) , and HbA1c levels were assessed as secondary outcomes .
RESULTS	Results showed that participants receiving MBCT and CBT reported significantly greater reductions in depressive symptoms compared with patients in the waiting-list control condition ( respectively , P = 0.004 and P < 0.001 ; d = 0.80 and 1.00 ; clinically relevant improvement 26 % and 29 % vs. 4 % ) .
RESULTS	Both interventions also had significant positive effects on anxiety , well-being , and diabetes-related distress .
RESULTS	No significant effect was found on HbA1c values .
CONCLUSIONS	Both individual MBCT and CBT are effective in improving a range of psychological symptoms in individuals with type 1 and type 2 diabetes .

###24946633
OBJECTIVE	To explore the better therapy in the treatment of ganglion .
METHODS	Ninety cases of ganglion were randomized into a two-way quintuple puncture group , a common quintuple puncture group and a fire needling group , 30 cases in each one .
METHODS	In the two-way quintuple puncture group , the `` 9-in-1 '' multiple penetrating needling technique was used .
METHODS	In the common quintuple puncture group , the traditional `` 5-in-1 '' multiple penetrating needling technique was applied .
METHODS	In the fire needling group , the traditional multiple fire needling technique was adopted .
METHODS	The treatment was given once a day , 3 treatments made one session and the efficacy was analyzed statistically after 1 session treatment in the three groups .
RESULTS	All of the three therapeutic methods achieved the efficacy on ganglion .
RESULTS	The curative rate was 96.7 % ( 29/30 ) in the two-way quintuple puncture group , which was better obviously than 66.7 % ( 20/30 ) in the common quintuple puncture group and 60.0 % ( 18/30 ) in the fire needling group ( both P < 0.01 ) .
CONCLUSIONS	The two-way quintuple puncture technique achieves the remarkably superior efficacy on ganglion as compared with the common quintuple puncture technique and fire needling technique .

###24323549
BACKGROUND	Existing evidence suggests that administration of intravenous fluids has been shown to improve outcomes including pain in gynecological laparoscopic surgery but the optimum fluid dose has not been determined .
OBJECTIVE	To determine the effect of administration of intravenous fluids on post-operative pain and pulmonary function after gynecological laparoscopy .
METHODS	In a prospective randomized double-blinded study 100 ASA 1 and 2 elective patients undergoing gynecological laparoscopy were randomized to receive intravenous compound sodium lactate 10 ml kg ( -1 ) ( CSL10-restrictive ) or 30 ml kg ( -1 ) ( CSL30-liberal ) administered intra-operatively .
METHODS	The primary outcome measure was the post-operative pain score at 24 , 48 and 72 h , assessed by 0-10 verbal rating scale ( VRS ) .
METHODS	Pulmonary function ( FEV1 , FVC , PEFR ) and oxygen saturation were also measured .
RESULTS	Patients who received CSL 30 had lower post-operative pain scores than CSL 10 ( ANCOVA-mean difference = 0.47 , 95 % CI 0.11-0 .83 , P = 0.01 ) .
RESULTS	Post-operative pain VRS was lower in CSL30 than CSL10 at 48 h ( mean difference 0.56 , 95 % CI 0.04-1 .09 , P = 0.036 ) .
RESULTS	Patients in CSL30 reported shoulder tip pain less frequently than those in CSL10 ( 30.4 vs. 43.9 % of assessments , P = 0.03 , OR 0.58 ) but reported wound pain more frequently 39.0 vs. 24.2 % , P = 0.01 , OR 2.0 ) .
RESULTS	Indices of pulmonary function did not differ between groups at any time .
CONCLUSIONS	Liberal compared to restrictive administration of i.v. crystalloid is associated with a clinical modest reduction in pain .
CONCLUSIONS	Pulmonary dysfunction was not increased with liberal fluid administration .

###25403144
BACKGROUND	Borderline personality disorder ( BPD ) is associated with a high socioeconomic burden .
BACKGROUND	Although a number of evidence-based treatments for BPD are currently available , they are not widely disseminated ; furthermore , there is a need for more research concerning their efficacy and cost-effectiveness .
BACKGROUND	Such knowledge promises to lead to more efficient use of resources , which will facilitate the effective dissemination of these costly treatments .
BACKGROUND	This study focuses on the efficacy and cost-effectiveness of Mentalization-Based Treatment ( MBT ) , a manualized treatment for patients with BPD .
BACKGROUND	Studies to date have either investigated MBT in a day hospitalization setting ( MBT-DH ) or MBT offered in an intensive outpatient setting ( MBT-IOP ) .
BACKGROUND	No trial has compared the efficacy and cost-effectiveness of these MBT programmes .
BACKGROUND	As both interventions differ considerably in terms of intensity of treatment , and thus potentially in terms of efficacy and cost-effectiveness , there is a need for comparative trials .
BACKGROUND	This study therefore sets out to investigate the efficacy and cost-effectiveness of MBT-DH versus MBT-IOP in patients with BPD .
BACKGROUND	A secondary aim is to investigate the association between baseline measures and outcome , which might improve treatment selection and thus optimize efficacy and cost-effectiveness .
METHODS	A multicentre randomized controlled trial comparing MBT-DH versus MBT-IOP in severe BPD patients .
METHODS	Patients are screened for BPD using the Structured Clinical Interview for DSM-IV Axis II Personality Disorders , and are assessed before randomization , at the start of treatment and 6 , 12 , 18 , 24 , 30 and 36 months after the start of treatment .
METHODS	Patients who refuse to participate will be offered care as usual in the same treatment centre .
METHODS	The primary outcome measure is symptom severity as measured by the Brief Symptom Inventory .
METHODS	Secondary outcome measures include parasuicidal behaviour , depression , substance use , social , interpersonal , and personality functioning , attachment , mentalizing capacities , and quality of life .
METHODS	All analyses will be conducted based on the intention-to-treat principle .
METHODS	Cost-effectiveness will be calculated based on costs per quality-adjusted life-year .
CONCLUSIONS	This multisite randomized trial will provide data to refine criteria for treatment selection for severe BPD patients and promises to optimize ( cost - ) effectiveness of the treatment of BPD patients .
BACKGROUND	NTR2292 .
BACKGROUND	Registered 16 April 2010 .

###24520387
BACKGROUND	Neuroplasticity drives recovery of walking after a lesion of the descending tract .
BACKGROUND	Intramuscular coherence analysis provides a way to quantify corticomotor drive during a functional task , like walking and changes in coherence serve as a marker for neuroplasticity .
BACKGROUND	Although intramuscular coherence analysis is already applied and rapidly growing in interest , the reproducibility of variables derived from coherence is largely unknown .
BACKGROUND	The purpose of this study was to determine the test-retest reliability and agreement of intramuscular coherence variables obtained during walking in healthy subjects .
RESULTS	Ten healthy participants walked on a treadmill at a slow and normal speed in three sessions .
RESULTS	Area of coherence and peak coherence were derived from the intramuscular coherence spectra calculated using rectified and non-rectified M. tibialis anterior Electromyography ( EMG ) .
RESULTS	Reliability , defined as the ability of a measurement to differentiate between subjects and established by the intra-class correlation coefficient , was on the limit of good for area of coherence and peak coherence when derived from rectified EMG during slow walking .
RESULTS	Yet , the agreement , defined as the degree to which repeated measures are identical , was low as the measurement error was relatively large .
RESULTS	The smallest change to exceed the measurement error between two repeated measures was 66 % of the average value .
RESULTS	For normal walking and/or other EMG-processing settings , not rectifying the EMG and/or high-pass filtering with a high cutoff frequency ( 100 Hz ) the reliability was only moderate to poor and the agreement was considerably lower .
CONCLUSIONS	Only for specific conditions and EMG-processing settings , the derived coherence variables can be considered to be reliable measures .
CONCLUSIONS	However , large changes ( > 66 % ) are needed to indicate a real difference .
CONCLUSIONS	So , although intramuscular coherence is an easy to use and a sufficiently reliable tool to quantify intervention-induced neuroplasticity , the large effects needed to reveal a real change limit its practical use .

###26081329
OBJECTIVE	To analyze the efficacy and safety of mexidol and their effect on the dynamics of neurological signs of the disease , emotional status and quality of life in patients with chronic cerebral ischemia ( CCI ) .
METHODS	We studied 45 patients with CCI who received mexidol in dose 500 mg a day during 14 days by introvenal introduction with the following peroral administration in doses 500 mg twice a day during 60 days .
METHODS	A comparison group included 30 patients with CCI matched for age , risk factors and severity of neurological symptoms , who did not receive mexidol .
METHODS	Patients of both groups received standard treatment that included medications needed for the complete correction of the risk factors .
METHODS	Cognitive function ( MMSE ) , movement activity and quality of life ( SF-36 ) were assessed .
RESULTS	To the end of the study ( 74th day ) , a decrease in the severity of movement disorders , normalization of SF-36 scores and improvement of mean values of screening-assessment of cognitive function were identified in patients of the main group compared to those of the comparison group .
CONCLUSIONS	The high efficacy and safety of treatment of CCI patients with mexidol using .

###24862170
OBJECTIVE	To compare the efficacy of non-nutritive sweetened beverages ( NNS ) or water for weight loss during a 12-week behavioral weight loss treatment program .
METHODS	An equivalence trial design with water or NNS beverages as the main factor in a prospective randomized trial among 303 men and women was employed .
METHODS	All participants participated in a behavioral weight loss treatment program .
METHODS	The results of the weight loss phase ( 12 weeks ) of an ongoing trial ( 1 year ) that is also evaluating the effects of these two treatments on weight loss maintenance were reported .
RESULTS	The two treatments were not equivalent with the NNS beverage treatment group losing significantly more weight compared to the water group ( 5.95 kg versus 4.09 kg ; P < 0.0001 ) after 12 weeks .
RESULTS	Participants in the NNS beverage group reported significantly greater reductions in subjective feelings of hunger than those in the water group during 12 weeks .
CONCLUSIONS	These results show that water is not superior to NNS beverages for weight loss during a comprehensive behavioral weight loss program .

###25494823
BACKGROUND	Adequate monitoring tools are required to optimise the immunosuppressive therapy of an individual patient .
BACKGROUND	Particularly , in calcineurin inhibitors , as critical dose drugs with a narrow therapeutic range , the optimal monitoring strategies are discussed in terms of safety and efficacy .
BACKGROUND	Nevertheless , no pharmacokinetic monitoring markers reflect the biological activity of the drug .
BACKGROUND	A new quantitative analysis of gene expression was employed to directly measure the functional effects of calcineurin inhibition : the transcriptional activities of the nuclear factor of activated T-cell ( NFAT ) - regulated genes in the peripheral blood .
METHODS	The CIS study is a randomised prospective controlled trial , comparing a ciclosporin A ( CsA ) - based immunosuppressive regimen monitored by CsA trough levels to a CsA-based immunosuppressive regimen monitored by residual NFAT-regulated gene expression .
METHODS	Pulse wave velocity as an accepted surrogate marker of the cardiovascular risk is assessed in both study groups .
METHODS	Our hypothesis is that an individualised CsA therapy monitored by residual NFAT-regulated gene expression results in a significantly lower cardiovascular risk compared to CsA therapy monitored by CsA trough levels .
CONCLUSIONS	There is a lack of evidence in individualising standard immunosuppression in renal allograft recipients .
CONCLUSIONS	The CIS study will consider the feasibility of individualised ciclosporin A immunosuppression by pharmacodynamic monitoring and evaluate the opportunity to reduce cardiovascular risk while maintaining sufficient immunosuppression .
BACKGROUND	EudraCT identifier 2011-003547-21 , registration date 18 July 2011https : / / www.clinicaltrialsregister.eu .

###24944257
OBJECTIVE	To systematically study the effects of shared medical appointments ( SMAs ) compared with individual appointments for patients with a chronic neuromuscular disorder and their partners .
METHODS	In this randomized controlled trial with a follow-up of 6 months , we included patients with a chronic neuromuscular disorder and their partners .
METHODS	Participants were randomly allocated to an SMA or an individual outpatient appointment .
METHODS	The primary outcome measure was patients ' health-related quality of life ( QOL ) ( 36-Item Short Form Health Survey ) .
METHODS	Secondary outcome measures included self-efficacy , social support , patient and partner satisfaction with the appointment , and time available per patient .
RESULTS	Two hundred seventy-two patients and 149 partners were included .
RESULTS	Health-related QOL showed greater improvement in patients who had attended an SMA ( mean difference 2.8 points , 95 % confidence interval 0.0-5 .7 , p = 0.05 ) .
RESULTS	Secondary outcomes showed small improvements in the control group for satisfaction with the appointment ( p = 0.01 ) .
RESULTS	Neurologists spent less time per patient during the SMAs : mean 16 minutes ( range 11-30 ) vs. 25 minutes ( range 20-30 ) for individual appointments .
CONCLUSIONS	This study provides evidence that SMAs can improve aspects of QOL of patients with a chronic neuromuscular disorder .
CONCLUSIONS	This could result in an alternative to individual appointments and improvements in both effectiveness and efficiency .
CONCLUSIONS	Further research to optimize SMAs and to identify critical success factors seems warranted .
CONCLUSIONS	These data extend evidence on SMAs for neurologic patients .
METHODS	This study provides Class III evidence that for patients with chronic neuromuscular disorders , SMAs improve QOL as compared with individual medical appointments .

###26281171
OBJECTIVE	To study features of lipid peroxidation in patients with different types of gastroesophageal reflux disease ( GERD ) .
METHODS	We examined 120 patients with different clinical variants of GERD and 25 healthy individuals .
METHODS	It was determined the concentration of diene conjugates ( DC ) ketodienes ( KD ) , conjugated trienes ( CT ) by biochemical methods in serum and mucosal biopsies of the lower third of the esophagus .
RESULTS	In biopsies of esophagus mucosa the content of DK , CD , CT was increased in patients with complications of GERD ( ulcerative esophagitis and Barrett 's esophagus ) in 2,2-5 ,3 times compared with healthy individuals .
RESULTS	In blood serum registered similar but less pronounced regularities .
CONCLUSIONS	It was revealed a significant intensification of free radical oxidation in the tissues of the esophagus and the blood of patients with GERD , which was exacerbated in proportion to the severity of the disease .

###25038733
BACKGROUND	Our previous studies have demonstrated the treatment benefits of dense cranial electroacupuncture stimulation ( DCEAS ) , a novel brain stimulation therapy in patients with major depression , postpartum depression and obsessive-compulsive disorder .
BACKGROUND	The purpose of the present study was to further evaluate the effectiveness of DCEAS combined with body acupuncture and selective serotonin reuptake inhibitors ( SSRIs ) in patients with post-stroke depression ( PSD ) .
METHODS	In a single-blind , randomized controlled trial , 43 patients with PSD were randomly assigned to 12 sessions of DCEAS plus SSRI plus body electroacupuncture ( n = 23 ) , or sham ( non-invasive cranial electroacupuncture , n-CEA ) plus SSRI plus body electroacupuncture ( n = 20 ) for 3 sessions per week over 4 weeks .
METHODS	Treatment outcomes were measured using the 17-item Hamilton Depression Rating Scale ( HAMD-17 ) , the Clinical Global Impression - Severity scale ( CGI-S ) and Barthel Index ( BI ) , a measure used to evaluate movement ability associated with daily self-caring activity .
RESULTS	DCEAS produced a significantly greater reduction of both HAMD-17 and CGI-S as early as week 1 and CGI-S at endpoint compared to n-CEA , but subjects of n-CEA group exhibited a significantly greater improvement on BI at week 4 than DCEAS .
RESULTS	Incidence of adverse events was not different in the two groups .
CONCLUSIONS	These results indicate that DCEAS could be effective in reducing stroke patients ' depressive symptoms .
CONCLUSIONS	Superficial electrical stimulation in n-CEA group may be beneficial in improving movement disability of stroke patients .
CONCLUSIONS	A combination of DCEAS and body acupuncture can be considered a treatment option for neuropsychiatric sequelae of stroke .
BACKGROUND	http://www.clinicaltrials.gov , NCT01174394 .

###24867391
OBJECTIVE	To evaluate safety , tolerability , seizure frequency , and regional variations in treatment responses with the AMPA antagonist , perampanel , in a large extension study during up to 3 years of treatment .
METHODS	Patients 12 years old with partial-onset seizures despite treatment with 1-3 antiepileptic drugs at baseline completed a perampanel phase III trial and entered extension study 307 ( NCT00735397 ) .
METHODS	Patients were titrated to 12 mg/day ( or their individual maximum tolerated dose ) during the blinded conversion period , followed by open-label maintenance .
METHODS	Exposure , safety ( adverse events [ AEs ] , vital signs , weight , electrocardiography [ ECG ] , laboratory values ) and seizure outcomes were analyzed ; key measures were assessed by geographic regions .
RESULTS	Among 1,216 patients , median exposure was 1.5 years ( range 1 week to 3.3 years ) , with > 300 patients treated for > 2 years .
RESULTS	Treatment retention was 58.5 % at cutoff .
RESULTS	AEs reported in 10 % of patients were dizziness , somnolence , headache , fatigue , irritability , and weight increase .
RESULTS	Only dizziness and irritability caused discontinuation in > 1 % of patients ( 3.9 % and 1.3 % , respectively ) .
RESULTS	The only serious AEs reported in > 1 % of patients were epilepsy-related ( convulsion , 3.0 % ; status epilepticus , 1.1 % ) .
RESULTS	No clinically relevant changes in vital signs , ECG or laboratory parameters were seen .
RESULTS	After titration/conversion , responder rate and median percentage change from baseline in seizure frequency were stable : 46 % for both measures at 9 months ( in 980 patients with 9 months ' exposure ) and 58 % and 60 % , respectively , at 2 years ( in the 337 patients with 2 years ' exposure ) .
RESULTS	Median percentage reduction in frequency of secondarily generalized ( SG ) seizures ranged from 77 % at 9 months ( N = 422 ) to 90 % at 2 years ( N = 141 ) .
RESULTS	Among the 694 patients with maintenance data 1 year , 5.3 % were seizure-free for the entire year .
CONCLUSIONS	No new safety signals emerged during up to 3 years of perampanel exposure in 39 countries .
CONCLUSIONS	Seizure responses remained stable , with marked reductions , particularly in SG seizures .

###25248449
BACKGROUND	Sensitivity of the myofascial trigger point ( MTrP ) can be inhibited by electrical stimulation of remote site .
BACKGROUND	However , it remains unclear whether remote pain control of the MTrP occurs in the same spinal segment or in the supraspinal system .
OBJECTIVE	The aims of this study were to identify whether the remote pain control occurs in the spinal segment corresponding to the MTrP or in the supraspinal system .
METHODS	Test subjects ( n = 10 ) received transcutaneous electrical nerve stimulation for 5 minutes , whereas control subjects ( n = 10 ) received no intervention .
METHODS	The threshold for tactile sensory modulation at the lateral elbow was assessed using Von Frey filaments .
METHODS	The pressure sensitivities of MTrPs in both the infraspinatus and upper trapezius muscles were quantified by algometry .
METHODS	Measurements were performed at baseline and 1 and 15 minutes after the intervention .
RESULTS	Increases of the tactile threshold at the remote site decreased the sensitivity of the MTrP innervated by same spinal segment .
RESULTS	However , no changes were observed at MTrP sites innervated by contralateral fibers or those from different spinal segment .
CONCLUSIONS	MTrP sensitivity is more strongly affected by interventions at remote ipsilateral sites in the same spinal segment than by stimulation of extra-segmental sites .

###24726205
BACKGROUND	Thrombocytopenia occurs in 20 % to 45 % of critically ill medical-surgical patients .
BACKGROUND	The 4Ts heparin-induced thrombocytopenia ( HIT ) score ( with 4 domains : Thrombocytopenia , Timing of thrombocytopenia , Thrombosis and oTher reason [ s ] for thrombocytopenia ) might reliably identify patients at low risk for HIT .
BACKGROUND	Interobserver agreement on 4Ts scoring is uncertain in this setting .
OBJECTIVE	To evaluate whether a published clinical prediction rule ( the `` 4Ts score '' ) reliably rules out HIT in `` low-risk '' intensive care unit ( ICU ) patients as assessed by research coordinators ( who prospectively scored ) and 2 adjudicators ( who scored retrospectively ) during an international heparin thromboprophylaxis trial ( PROTECT , NCT00182143 ) .
METHODS	Of 3746 medical-surgical ICU patients in PROTECT , 794 met the enrollment criteria for this HIT substudy .
METHODS	Enrollment was predicated on one of the following occurring in ICU : platelets less than 5010 ( 9 ) / L , platelets decreased to 50 % of ICU admission value ( if admission value < 10010 ( 9 ) / L ) , any venous thrombosis , or if HIT was otherwise clinically suspected .
METHODS	Independently , 4Ts scores were completed in real time by research coordinators blinded to study drug and laboratory HIT results , and retrospectively by 2 adjudicators blinded to study drug , laboratory HIT results , and research coordinators ' scores ; the adjudicators arrived at consensus in all cases .
METHODS	Of the 763 patients , 474 had a central or local laboratory HIT test performed and had 4Ts scoring by adjudicators ; 432 were scored by trained research coordinators .
METHODS	Heparin-induced thrombocytopenia was defined by a centrally performed positive serotonin release assay ( SRA ) .
RESULTS	Of the 474 patients with central adjudication , 407 ( 85.9 % ) had a 4Ts score of 3 or lower , conferring a low pretest probability ( PTP ) of HIT ; of these , 6 ( 1.5 % [ 95 % confidence interval , 0.7 % -3.2 % ) had a positive SRA .
RESULTS	Fifty-nine ( 12.4 % ) had a moderate PTP ( 4Ts score of 4-5 ) ; of these , 4 ( 6.8 % ) had a positive SRA .
RESULTS	Eight patients had a high PTP ( 4Ts score of 6 ) ; of these , 1 ( 12.5 % ) had a positive SRA .
RESULTS	Raw agreement between research coordinators and central adjudication on each domain of the 4Ts score and low , intermediate , and high PTP was good .
RESULTS	However , chance-corrected agreement was variable between adjudicators ( weighted values of 0.31-0 .93 ) and between the adjudicator consensus and research coordinators ( weighted values of 0.13 and 0.78 ) .
RESULTS	Post hoc review of the 6 SRA-positive cases with an adjudicated low PTP demonstrated that their scores would have been increased if the adjudicators had had additional information on heparin exposure prior to ICU admission .
RESULTS	In general , the fourth domain of 4Ts ( oTher causes of thrombocytopenia ) generated the most disagreement .
CONCLUSIONS	Real-time 4Ts scoring by research coordinators at the time of testing for HIT was not consistent with 4Ts scores obtained by central adjudicators .
CONCLUSIONS	The results of this comprehensive HIT testing highlight the need for further research to improve the assessment of PTP scoring of HIT for critically ill patients .

###24998517
BACKGROUND	Subendocardial strain analysis is currently feasible in two-dimensional and three-dimensional ( 3D ) echocardiography ; however , there is a lack of clarity regarding the most useful strain component for subclinical disease detection .
BACKGROUND	The aim of this study was to test the hypothesis that strain analysis along the direction of strongest and weakest systolic compression ( referred to as principal and secondary strain , respectively ) circumvents the need for multidirectional strains and provides a more simplified assessment of left ventricular subendocardial function .
METHODS	Strain analyses were performed by using two-dimensional and 3D echocardiography in 41 consecutive subjects with normal results on electron-beam computed tomography , including 15 controls and 26 patients with systemic hypertension .
METHODS	The direction of principal strain referenced the myofiber geometry obtained from diffusion tensor magnetic resonance imaging of a normal autopsied human heart .
METHODS	The incremental value of principal strain over multidirectional two-dimensional and 3D strain was analyzed .
RESULTS	In healthy subjects , 50 3 % of the subendocardial shortening occurred in the cross-fiber direction ( left-handed helical ) ; this balance was significantly altered in patients with hypertension ( P = .01 ) .
RESULTS	The magnitude of longitudinal and circumferential strain was similar in patients with hypertension and controls .
RESULTS	However , the alteration of the directional contraction pattern resulted in reduced secondary strain magnitude in patients with hypertension ( P = .01 ) , and the differences were further exaggerated when the secondary strain was normalized by the principal strain magnitude ( P = .004 ) .
CONCLUSIONS	Two-component principal and secondary strain analysis can be related to left ventricular myofiber geometry and may simplify the assessment of 3D left ventricular deformation by circumventing the need to assess multiple shortening and shear strain components .

###25418907
BACKGROUND	Children with type 1 diabetes ( T1D ) and elevated LDL-C have an increased risk for cardiovascular disease , a process that can begin in childhood .
OBJECTIVE	To assess the safety and efficacy of atorvastatin improving lipid profiles in children with T1D and elevated LDL-C .
METHODS	Sixty children ( 31M/29F ) with T1D , mean age : 15 0.3 yr , mean diabetes duration : 6.8 0.5 yr , HbA ( 1c ) : 8.8 0.2 % , with mean LDL-C 124 4.0 mg/dl were recruited .
METHODS	After a 3-month run-in period , subjects were randomized double-blindly to atorvastatin or placebo for 6 months .
METHODS	Lipoprotein subfractions were measured by ion mobility and glucose control by HbA1C ; continuous glucose monitors were worn quarterly .
RESULTS	After a run-in period , 42 subjects were randomized .
RESULTS	There were decreases in total cholesterol ( -21 % ) , LDL-C ( -32 % ) , non-HDL-C ( -31 % ) and apoB ( -26 % ) in the atorvastatin group versus placebo ( p < 0.001 ) .
RESULTS	Lipoprotein subparticles ( LDL-large 1 and 2A , IDL-large and small , VLDL - medium and small ) decreased with statins ( p < 0.03 all ) .
RESULTS	Insulin sensitivity scores remained constant in both groups and correlated inversely with apoB ( r = -0.312 p = 0.039 ) and small LDL 3A ( r = -0.404 p = 0.007 ) .
RESULTS	One subject had asymptomatic elevation of creatinine kinase which normalized after atorvastatin discontinuation .
CONCLUSIONS	Atorvastatin lowered LDL-C , apoB , and atherogenic lipoprotein subparticles in children with T1D and elevated LDL-C without worsening insulin resistance .
CONCLUSIONS	The drug was well tolerated and safe .
CONCLUSIONS	Long-term studies would provide better insight on the impact of these interventions in the development of cardiovascular disease in children with diabetes .

###24448046
OBJECTIVE	Protected sleep periods for internal medicine interns have previously resulted in increased amount slept and improved cognitive alertness but required supplemental personnel .
OBJECTIVE	The authors evaluated intern and patient outcomes associated with protected nocturnal nap periods of three hours that are personnel neutral .
METHODS	Randomized trial at Philadelphia Veterans Affairs Medical Center ( PVAMC ) Medical Service and Hospital of the University of Pennsylvania ( HUP ) Oncology Unit .
METHODS	During 2010-2011 , four-week blocks were randomly assigned to a standard intern schedule ( extended duty overnight shifts of up to 30 hours ) , or sequential protected sleep periods ( phone sign-out midnight to 3:00 AM [ early shift ] intern 1 ; 3:00 to 6:00 AM [ late shift ] intern 2 ) .
METHODS	Participants wore wrist Actiwatches , completed sleep diaries , and performed daily assessments of behavioral alertness .
METHODS	Between-group comparisons of means and proportions controlled for within-person correlations .
RESULTS	HUP interns had significantly longer sleep durations during both early ( 2.40 hours ) and late ( 2.44 hours ) protected periods compared with controls ( 1.55 hours , P < .0001 ) .
RESULTS	At PVAMC sleep duration was longer only for the late shift group ( 2.40 versus 1.90 hours , P < .036 ) .
RESULTS	Interns assigned to either protected period were significantly less likely to have call nights with no sleep and had fewer attentional lapses on the Psychomotor Vigilance Test .
RESULTS	Differences in patient outcomes between standard schedule months versus intervention months were not observed .
CONCLUSIONS	Protected sleep periods of three hours resulted in more sleep during call and reductions in periods of prolonged wakefulness , providing a plausible alternative to 16-hour shifts .

###25155931
OBJECTIVE	Determine whether SNPs of OPRM1 118A > G ( asn ( 40 ) asp ) , COMT 472G > A ( val ( 158 ) met ) and ARRB2 8622C > T are associated with morphine rescue in newborns on mechanical ventilation .
METHODS	This is a pharmacogenetic analysis of a randomized controlled trial in ( pre ) term newborns ( n = 64 ) at a level III Neonatal Intensive Care Unit ( NICU ) who received placebo infusion and for whom need and dose for rescue morphine was documented .
RESULTS	For OPRM1 and COMT separately , the expected risk for rescue morphine or morphine dose was not significantly increased .
RESULTS	However , the combined OPRM1/COMT ` high-risk ' genotype lead to a significant association with the need for rescue ( OR : 5.12 ; 95 % CI : 1.12-23 .3 ; p = 0.035 ) .
RESULTS	No association was found between OPRM1/COMT ` high-risk ' genotype and total morphine dose administered .
CONCLUSIONS	Combined OPRM1 118A > G and COMT 472G > A genotype might serve as a predictor for the need of rescue morphine in premature and term newborns on mechanical ventilation .

###25040441
OBJECTIVE	To determine if application of silver sodium zirconium phosphate polyurethane semi-occlusive foam ( SPF ) dressing would improve measures of wound healing and decrease bacterial contamination compared with a non-adherent , absorbent dressing applied to wounds created on the distal aspect of the equine limb .
METHODS	Controlled randomized experimental study .
METHODS	Adult Quarter Horse and Thoroughbred horses ( n = 5 ) .
METHODS	One 6.25 cm ( 2 ) wound was created on the dorsomedial aspect of the proximal metacarpus on each forelimb .
METHODS	A SPF dressing was applied to 1 randomly assigned limb as a treatment and a non-adherent , absorbent dressing was applied to the opposite limb as control .
METHODS	Bandages were changed every 3 days for 60 days .
METHODS	Granulation tissue was scored every 3 days , wound area measured every 6 days , and wound bed was cultured every 12 days .
RESULTS	SPF-treatment wounds had significantly decreased wound area and decreased granulation tissue scores when evaluated < 30 days and over the 60 day study , although complete wound healing times were not significantly different .
RESULTS	Bacteria were cultured from all wounds at varying times throughout the study .
CONCLUSIONS	The SPF wound dressing improved some measures of wound healing compared with the control dressing , most significantly during the first 30 days .
CONCLUSIONS	This suggests that the SPF wound dressing may be useful in the early management of wounds on the equine lower limb .
CONCLUSIONS	Further studies using the SPF dressing are needed to characterize the temporal and cellular effects on wound healing and evaluate this dressing in a clinical environment .

###25592006
OBJECTIVE	The aim of this study was to investigate the effects of ingesting caffeine and green coffee bean extract on blood glucose and insulin concentrations during a post-exercise oral glucose tolerance test .
METHODS	Ten male cyclists ( age : 26 5 y ; height : 179.9 5.4 cm ; weight : 77.6 13.3 kg ; body mass index : 24 4.3 kg/m ( 2 ) ; VO2 peak : 55.9 8.4 mLkgmin ( -1 ) ) participated in this study .
METHODS	In a randomized order , each participant completed three 30-min bouts of cycling at 60 % of peak power output .
METHODS	Immediately after exercise , each participant consumed 75 g of dextrose with either 5 mg/kg body weight of caffeine , 10 mg/kg of green coffee bean extract ( 5 mg/kg chlorogenic acid ) , or placebo .
METHODS	Venous blood samples were collected immediately before and after exercise during completion of the oral glucose tolerance test .
RESULTS	No significant time treatment effects for blood glucose and insulin were found .
RESULTS	Two-h glucose and insulin area under the curve values , respectively , for the caffeine ( 658 74 mmol/L and 30,005 13,304 pmol/L ) , green coffee bean extract ( 637 100 mmol/L and 31,965 23,586 pmol/L ) , and placebo ( 661 77 mmol/L and 27,020 12,339 pmol/L ) trials were not significantly different ( P > 0.05 ) .
CONCLUSIONS	Caffeine and green coffee bean extract did not significantly alter postexercise blood glucose and insulin concentrations when compared with a placebo .
CONCLUSIONS	More human research is needed to determine the impact of these combined nutritional treatments and exercise on changes in blood glucose and insulin .

###24905427
OBJECTIVE	Exercise has beneficial effects on pain in knee osteoarthritis ( OA ) , yet the underlying mechanisms are unclear .
OBJECTIVE	The purpose of this study was to investigate the effects of exercise on pressure-pain sensitivity in patients with knee OA .
METHODS	In a randomized controlled trial , participants were assigned to 12 weeks of supervised exercise therapy ( ET ; 36 sessions ) or a no attention control group ( CG ) .
METHODS	Pressure-pain sensitivity was assessed by cuff pressure algometry on the calf of the most symptomatic leg .
METHODS	The coprimary outcomes were pressure-pain thresholds ( PPTs ) and cumulated visual analog scale pain scores during constant pressure for 6 minutes at 125 % of the PPT as a measure of temporal summation ( TS ) of pressure-pain .
METHODS	Secondary outcomes included self-reported pain using the Knee Injury and Osteoarthritis Outcome Score ( KOOS ) questionnaire .
METHODS	Analyses were based on the `` per-protocol '' population ( participants following the protocol ) .
RESULTS	Sixty participants were randomized ( 31 in ET group , 29 in CG ) , and the per-protocol population included 48 participants ( 25 in ET group , 23 in CG ) .
RESULTS	At followup , mean group differences in the change from baseline were 3.1 kPa ( 95 % confidence interval [ 95 % CI ] 0.2 , 6.0 ; P = 0.038 ) for the PPT , 2,608 mm seconds ( 95 % CI 458 , 4,758 ; P = 0.019 ) for TS , and 6.8 points ( 95 % CI 1.2 , 12.4 ; P = 0.018 ) for KOOS pain , all in favor of ET .
CONCLUSIONS	Pressure-pain sensitivity , TS , and self-reported pain are reduced among patients completing a 12-week supervised exercise program compared to a no attention CG .
CONCLUSIONS	These results demonstrate beneficial effects of exercise on basic pain mechanisms and further exploration may provide a basis for optimized treatment .

###25549681
OBJECTIVE	To explore the therapeutic effect evaluation of proton magnetic resonance spectroscopy ( ( 1 ) H-MRS ) in patients with vascular cognitive impairment no dementia ( VCIND ) with dioscorea modified pill .
METHODS	A total of 100 patients with VCIND were randomly assigned into the dioscorea modified pill group ( n = 50 ) and the aricept group ( n = 50 ) .
METHODS	And 50 healthy volunteers were recruited as normal group .
METHODS	Each patient was examined with ( 1 ) H-MRS and scored with mini-mental state examination ( MMSE ) and clinical dementia rating ( CDR ) scale pre - and post-treatment .
RESULTS	After therapy , the NAA/Cr ratios and the itemized scores of cognitive scale compared with that of pre-therapy had significantly difference ( P < 0.05 ) in the dioscorea modified pill group ( MMSE ( 26.5 2.0 ) , CDR ( 0.14 0.23 ) ) vs ( MMSE ( 25.1 2.3 ) , CDR ( 0.5 ) ) .
RESULTS	But no difference existed in the aricept group ( P > 0.05 ) .
CONCLUSIONS	( 1 ) H-MRS may objectively reflect cognitive dysfunction in VCIND patients .
CONCLUSIONS	And it has important values in the therapeutic effect evaluation of VCIND with dioscorea modified pill .

###24506429
OBJECTIVE	Soluble CD14 ( sCD14 ) is a monocyte activation marker associated with increased mortality in HIV infection .
OBJECTIVE	We assessed 48-week changes in sCD14 and other inflammatory biomarkers in virologically suppressed , HIV-infected women switching to raltegravir ( RAL ) from a protease inhibitor ( PI ) or nonnucleoside reverse transcriptase inhibitor ( NNRTI ) .
METHODS	HIV-infected women with central adiposity and HIV-1 RNA < 50 HIV-1 RNA copies/mL continued their thymidine-sparing nucleoside reverse transcriptase inhibitor ( NRTI ) backbone and were randomized to switch to open-label RAL at week 0 ( immediate ) or 24 ( delayed ) .
METHODS	In an exploratory analysis , inflammatory biomarkers were measured on stored fasting plasma .
RESULTS	Of the 37 evaluable subjects , 78 % were non-White ; the median age was 43 years , the median body mass index ( BMI ) was 32kg/m ( 2 ) and the median CD4 count was 558cells/L .
RESULTS	At baseline , biomarker values were similar between groups .
RESULTS	After 24 weeks , median sCD14 significantly declined in subjects switching to RAL [ -21 % ( P < 0.001 ) vs.PI / NNRTI -5 % ( P = 0.49 ) ; between-group P < 0.01 ] .
RESULTS	After 48 weeks , immediate-switch subjects maintained this decline and delayed-switch subjects experienced a similar decline following the switch to RAL ( -10 % ; within-group P < 0.01 ) .
RESULTS	Immediate-switch subjects also experienced an initial increase in tumour necrosis factor ( TNF ) - that was neither maintained after 48 weeks nor seen in delayed-switch subjects .
RESULTS	After adjustment for multiple testing , only declines in sCD14 remained significant .
CONCLUSIONS	In this randomized trial of women with central adiposity , a switch to RAL from a PI or NNRTI was associated with a statistically significant decline in sCD14 .
CONCLUSIONS	Further studies are needed to determine whether integrase inhibitors have improved monocyte activation profiles compared with PIs and/or NNRTIs , and whether measured differences between antiretroviral agents translate to demonstrable clinical benefit .

###24298784
OBJECTIVE	To evaluate the efficacy of abdominal acupuncture for adhesion-stage shoulder periarthritis .
METHODS	One hundred and fifty-seven cases of shoulder periarthritis were randomly divided into an abdominal acupuncture group ( 79 cases ) and a body acupuncture group ( 78 cases ) .
METHODS	The abdominal acupuncture was applied at Zhongwan ( CV 12 ) , Shangqu ( KI 17 ) and Huaroumen ( ST 24 ) in the abdominal acupuncture group while conventional acupuncture was applied at Jianyu ( LI 15 ) , Jianliao ( TE 14 ) and Jianzhen ( SI 9 ) in the body acupuncture group .
METHODS	The treatment was given three times a week for both groups and ten times made an observation course .
METHODS	Before and after treatment , visual analogue scale ( VAS ) was adopted for pain assessment and functional activity score ( Mallet score ) was used for shoulder joint function assessment for all the patients .
METHODS	Also the efficacy of both groups was compared .
RESULTS	The total effective rate in the abdominal acupuncture group was 92.4 % ( 73/79 ) , which was superior to 71.8 % ( 56/78 ) in the body acupuncture group .
RESULTS	The score of VAS after the treatment was 2.58 + / - 1.64 in the abdominal acupuncture group while 3.12 + / - 1.93 in the body acupuncture group , which had no statistical significance between each other ( P > 0.05 ) .
RESULTS	The functional activity score after the treatment was 8.34 + / - 3.02 in the abdominal acupuncture group while 7.49 + / - 3.36 in the body acupuncture group , which had no statistical significance between each other ( P > 0.05 ) .
CONCLUSIONS	The abdominal acupuncture is an ideal treatment for adhesion-stage shoulder periarthritis , which has better total efficacy than conventional acupuncture .
CONCLUSIONS	It achieves the same effect in relieving pain and improving functional activity as conventional acupuncture , but also has an advantage at fast selection of acupoint and less discomfort of needling sensation .

###24452845
OBJECTIVE	We evaluated the feasibility of a trial of Wii interactive video gaming , and its potential efficacy at improving cognitive functioning compared with health education , in a community sample of older adults with neuropsychologically defined mild cognitive impairment .
METHODS	Twenty older adults were equally randomized to either group-based interactive video gaming or health education for 90min each week for 24weeks .
METHODS	Although the primary outcomes were related to study feasibility , we also explored the effect of the intervention on neuropsychological performance and other secondary outcomes .
RESULTS	All 20 participants completed the intervention , and 18 attended at least 80 % of the sessions .
RESULTS	The majority ( 80 % ) of participants were `` very much '' satisfied with the intervention .
RESULTS	Bowling was enjoyed by the most participants and was also rated the highest among the games for mental , social , and physical stimulation .
RESULTS	We observed medium effect sizes for cognitive and physical functioning in favor of the interactive video gaming condition , but these effects were not statistically significant in this small sample .
CONCLUSIONS	Interactive video gaming is feasible for older adults with mild cognitive impairment , and medium effect sizes in favor of the Wii group warrant a larger efficacy trial .

###25840299
OBJECTIVE	To assess the effect of preoperative topical nonsteroidal antiinflammatory drugs ( NSAIDs ) on postoperative pain after laser-assisted subepithelial keratectomy ( LASEK ) and to investigate their mechanism .
METHODS	Severance Eye Hospital and Saeyan Eye Clinic , Seoul , South Korea .
METHODS	Prospective randomized clinical trial .
METHODS	Participants in 2 related studies were assessed .
METHODS	Study 1 comprised patients scheduled for bilateral LASEK ( Group 1 ) who were randomized to receive an NSAID in 1 eye and a placebo in the fellow eye 30 , 20 , and 10 minutes before LASEK .
METHODS	Postoperative pain , glare , tearing , and irritation were assessed using a visual analog scale .
METHODS	Study 2 comprised healthy subjects ( Group 2 ) who were randomly divided into subgroups .
METHODS	The participants in these subgroups were randomized to receive ketorolac tromethamine 0.5 % in 1 eye and placebo ( ofloxacin 0.3 % ) in the fellow eye ( Group 2A ) , proparacaine hydrochloride 0.5 % in 1 eye and placebo in the fellow eye ( Group 2B ) , or ketorolac tromethamine 0.5 % in 1 eye and placebo in the fellow eye , followed 10 minutes later by 1 drop of proparacaine hydrochloride 0.5 % in both eyes ( Group 2C ) .
METHODS	In all 3 groups , corneal sensitivity was measured after 1 , 2 , and 6 hours .
RESULTS	The mean postoperative pain score in the NSAID-pretreated eye was statistically significantly lower than in the placebo-pretreated eye 6 , 12 , and 24 hours postoperatively ( P < .05 ) .
RESULTS	The mean corneal sensitivity was statistically significantly lower in the NSAID-treated eye than in the placebo-treated eye at 1 and 2 hours in Groups 2A and 2C ( P < .05 ) .
CONCLUSIONS	Preoperative administration of topical NSAIDs before LASEK effectively reduces postoperative pain .
BACKGROUND	No author has a financial or proprietary interest in any material or method mentioned .

###25159356
BACKGROUND	Sufentanil sublingual microtablets ( SSMs ) at a dose of 15 g per tablet have been studied for postoperative patient-controlled analgesia with a 20-minute lockout via a bedside handheld system over 2 days to 3 days of use .
BACKGROUND	For more short-term ( < 24 hours ) management of acute moderate-to-severe pain , such as in the ambulatory surgical setting , a single , higher-strength SSM dose administered via a health care provider would be of benefit as it would require less frequent administration and avoid the setup of a drug delivery system .
METHODS	This study was a two-center , randomized , double-blind , placebo-controlled trial for 12 hours in patients 18 years to 80 years of age who were undergoing bunionectomy alone or with hammertoe repair .
METHODS	Patients were randomly assigned at a 2:2:1 ratio to treatment with SSM 20 g , SSM 30 g , or placebo .
METHODS	The primary endpoint was time-weighted summed pain intensity difference to baseline over 12 hours ( SPID12 ) .
METHODS	Patients had to have a pain intensity score of 4 or higher just before initial microtablet dosing .
METHODS	Additional doses were administered when requested by the patient , with a minimum redosing interval of 1 hour .
RESULTS	One hundred patients were randomized and received study drug .
RESULTS	The SSM 30 g was superior in the treatment of postbunionectomy surgical pain compared with placebo as demonstrated by the SPID12 score ( 6.53 vs. -7.12 , respectively ; p = 0.003 ) as well as all other secondary efficacy end points .
RESULTS	The SSM 20-g dosage strength was not superior to placebo for primary or secondary efficacy measures .
RESULTS	Adverse events were similar among the three groups with the exception of nausea , vomiting , and somnolence , which demonstrated a dose-dependent increase in occurrence .
CONCLUSIONS	The SSM 30 g may be an effective , noninvasive alternative to health care provider-administered intravenous , intramuscular , or oral opioids for the management of moderate-to-severe acute pain .
METHODS	Therapeutic study , level I.

###24576148
OBJECTIVE	Fibromyalgia ( FM ) is a chronic disorder that can have a devastating effect on patients ' lives .
OBJECTIVE	This study assessed the efficacy of a 6-week interdisciplinary treatment that combines coordinated PSYchological , Medical , Educational , and PHYsiotherapeutic interventions ( PSYMEPHY ) compared with standard pharmacologic care .
METHODS	The study was a randomized controlled trial ( 54 participants in the PSYMEPHY group and 56 in the control group [ CG ] ) with follow-up at 6 months .
METHODS	PSYMEPHY patients were also assessed at 12 months .
METHODS	The main outcomes were changes in total Fibromyalgia Impact Questionnaire ( FIQ ) score , pain , fatigue , morning tiredness , anxiety , and use of pain coping strategies as measured by the FIQ , the visual analog scale , and the Coping with Chronic Pain Questionnaire .
METHODS	After the 6-month assessment , patients in the CG were offered the PSYMEPHY treatment , and completed all of the instruments immediately after treatment , and at 6 - and 12-month follow-up visits ( N = 93 ) .
METHODS	Subjects received therapy at two different outpatient clinical locations .
METHODS	Fibromyalgia patients .
RESULTS	Six months after the intervention , significant improvements in total FIQ score ( P = 0.04 ) , and pain ( P = 0.03 ) were seen in the PSYMEPHY group compared with controls .
RESULTS	Twelve months after the intervention , all patients in the PSYMEPHY group maintained statistically significant improvements in total FIQ score , and pain , and showed an improvement in fatigue , rested , anxiety , and current pain compared with baseline .
RESULTS	Data from the control patients who underwent the PSYMEPHY intervention corroborated the initial results .
CONCLUSIONS	This study highlights the beneficial effects of an interdisciplinary treatment for FM patients in a hospital pain management unit .
CONCLUSIONS	A 6-week interdisciplinary intervention showed significant improvement in key domains of fibromyalgia , as quality of life , pain , fatigue , rested , and anxiety at 12 months .

###24597866
BACKGROUND	Radical prostatectomy reduces mortality among men with localized prostate cancer ; however , important questions regarding long-term benefit remain .
METHODS	Between 1989 and 1999 , we randomly assigned 695 men with early prostate cancer to watchful waiting or radical prostatectomy and followed them through the end of 2012 .
METHODS	The primary end points in the Scandinavian Prostate Cancer Group Study Number 4 ( SPCG-4 ) were death from any cause , death from prostate cancer , and the risk of metastases .
METHODS	Secondary end points included the initiation of androgen-deprivation therapy .
RESULTS	During 23.2 years of follow-up , 200 of 347 men in the surgery group and 247 of the 348 men in the watchful-waiting group died .
RESULTS	Of the deaths , 63 in the surgery group and 99 in the watchful-waiting group were due to prostate cancer ; the relative risk was 0.56 ( 95 % confidence interval [ CI ] , 0.41 to 0.77 ; P = 0.001 ) , and the absolute difference was 11.0 percentage points ( 95 % CI , 4.5 to 17.5 ) .
RESULTS	The number needed to treat to prevent one death was 8 .
RESULTS	One man died after surgery in the radical-prostatectomy group .
RESULTS	Androgen-deprivation therapy was used in fewer patients who underwent prostatectomy ( a difference of 25.0 percentage points ; 95 % CI , 17.7 to 32.3 ) .
RESULTS	The benefit of surgery with respect to death from prostate cancer was largest in men younger than 65 years of age ( relative risk , 0.45 ) and in those with intermediate-risk prostate cancer ( relative risk , 0.38 ) .
RESULTS	However , radical prostatectomy was associated with a reduced risk of metastases among older men ( relative risk , 0.68 ; P = 0.04 ) .
CONCLUSIONS	Extended follow-up confirmed a substantial reduction in mortality after radical prostatectomy ; the number needed to treat to prevent one death continued to decrease when the treatment was modified according to age at diagnosis and tumor risk .
CONCLUSIONS	A large proportion of long-term survivors in the watchful-waiting group have not required any palliative treatment .
CONCLUSIONS	( Funded by the Swedish Cancer Society and others . )

###25479296
OBJECTIVE	To evaluate the effectiveness of a 3-month treadmill desk intervention in eliciting changes in physical activity and sedentary behavior among overweight/obese office workers .
METHODS	A randomized controlled trial was conducted among overweight/obese office workers ( n = 41 ; mean age = 40.1 10.1 years ) at a private workplace .
METHODS	Participants were randomly assigned to a shared-treadmill desk intervention ( n = 21 ) or a usual working condition control group ( n = 20 ) .
METHODS	Accelerometer-determined physical activity and sedentary behavior were measured before and after the intervention .
RESULTS	Compared with the control group , the intervention group increased daily steps ( 1622 steps/day ; P = 0.013 ) and light physical activity ( 1.6 minutes/hour ; P = 0.008 ) , and decreased sedentary time ( -3.6 minutes/hour ; P = 0.047 ) during working hours .
CONCLUSIONS	Shared-treadmill desks in the workplace can be effective at promoting favorable changes in light physical activity ( specifically 40 to 99 steps/minute ) and sedentary behavior among overweight/obese office workers .

###25219986
BACKGROUND	Lower impacted third molar surgical extraction usually causes post-surgical sequelae like pain , trismus and swelling as a result of postoperative inflammatory response .
OBJECTIVE	The aim of this study was to evaluate and compare the efficacy of single dose 40-mg ( 1 cc ) of methylprednisolone acetate , injected into the masseter muscle , preoperatively one hour before the surgery or post-operatively , immediately following the surgical removal of impacted lower third molars , in controlling most common postoperative sequelae , i.e. trismus , pain and swelling of facial soft tissue .
METHODS	A randomized control study was done of 60 patients .
METHODS	Each patient was categorized in two groups , group I and group II , according to the time of receiving methylprednisolone acetate .
METHODS	Group I was injected 40 mg of methylprednisolone acetate into the masseter muscle via the intrabuccal approach , one hour before the surgery .
METHODS	Group II was injected 40 mg of methylprednisolone acetate into the masseter muscle via the intrabuccal approach , immediately after suturing of the surgical wound .
METHODS	The washout period was one month after the first operation .
METHODS	Evaluation were made of postoperative pain , trismus and swelling .
METHODS	The numeric pain scale ( NPS ) was used for pain assessment .
RESULTS	When the patients were administered methylprednisolone acetate preoperatively , showed superior results in terms of oral aperture , pain and all the facial swelling parameters , with statistically significant differences versus the postoperatively administered methylprednisolone acetate ( p < 0.05 ) .
CONCLUSIONS	A single dose of 40 mg ( 1 cc ) methylprednisolone acetate injected into the masseter muscle preoperatively is more effective in reducing pain , trismus and swelling , when compared to that administered postoperatively .

###25218880
BACKGROUND	Gaining too much weight in pregnancy poses health risks for mother and child .
BACKGROUND	Eating style has been shown to be related to weight gain in general but the relation to maternal weight gain in pregnancy is unclear .
OBJECTIVE	To assess the influence of eating style and psycho social factors on maternal weight gain .
METHODS	Healthy pregnant women ( n = 161 ) , filled in a questionnaire at 15 and 35 weeks of pregnancy .
METHODS	Eating style , social norm , self-efficacy and attitude with regard to weight gain and health during pregnancy were measured .
METHODS	Self-reported pre-pregnancy body mass index ( BMI ) was used to determine weight category and weight was objectively measured at 15 and 35 weeks of gestation .
METHODS	Linear regression was used to study the relationship between eating style , psychosocial factors and gestational weight gain , controlling for BMI and age .
METHODS	Hierarchical regression analyses were carried out where the effects of the other eating styles were partialled out .
RESULTS	During pregnancy , 66 % of the women remained stable as far as individual eating style concerned .
RESULTS	At 15 weeks of gestation , 11 ( 7 % ) women were classified as emotional eaters , 89 ( 55 % ) as external eaters and 61 ( 38 % ) as restrained eaters .
RESULTS	At first sight being an emotional eater was associated with higher weight gain in pregnancy .
RESULTS	In hierarchical regression analyses however none of the eating styles was associated with higher gestational weight gain .
RESULTS	Of the psychosocial factors , a better healthy pregnancy attitude at 35 weeks of gestation was associated with less weight gain .
CONCLUSIONS	In the long list of potential drivers of gestational weight gain , eating style does not seem to be of any significance .
CONCLUSIONS	Healthy pregnancy attitude in late pregnancy was found to be related with less weight gain .

###25527165
BACKGROUND	The prevalence of chronic venous disease is high and occurs more frequently in females .
BACKGROUND	According to the clinical , etiological , anatomical , and pathological classification ( CEAP ) definition , the reticular veins are included in the C1 class and are mainly associated with aesthetic complaints .
BACKGROUND	Several invasive techniques are used for treatment , including mini phlebectomy , laser ablation , and radiofrequency ablation .
BACKGROUND	However , a wide range of sclerosing agents may serve as minimally invasive alternatives , promoting chemical sclerosis of the vein wall .
BACKGROUND	Although this technique is routinely performed around the world , there is no consensus on the most efficacious and safe chemical agent to be used .
METHODS	Inclusion criteria are women between 18 and 69 years old with at least 10 cm long reticular veins in the lower limbs , on the outer side of the leg/thigh .
METHODS	Patients with CEAP 2 to 6 , or with allergies , pregnancy , performing breastfeeding , or with any dermatologic or clinical problems will be excluded .
METHODS	Patients with venous ultrasound mapping showing involvement of saphenous trunks and/or a deep venous system will also be excluded .
METHODS	Patients will be randomized into two groups , one receiving 75 % pure glucose and the other group receiving 0.2 % polidocanol diluted in 70 % glucose .
METHODS	Just one limb and one session per patient will be performed .
METHODS	The sclerosing agent volume will not exceed 5 mL .
METHODS	Clinical follow-up will include visits on days 7 and 60 , always with photographic documentation .
CONCLUSIONS	This project aims to enroll 96 patients and subject them to a double-blind treatment after the randomization process .
CONCLUSIONS	The design is intended to evaluate efficacy through a primary end point and safety through a secondary end point .
CONCLUSIONS	Forty-eight patients have currently been enrolled .
CONCLUSIONS	Preliminary results for these patients showed that 25 received treatment , 2 were excluded , and 22 returned after 7 days and showed no greater adverse events .
CONCLUSIONS	To date , establishing efficacy criteria has not been possible , and no patients have reached the 60-day return point .
CONCLUSIONS	These data may help doctors choose the best chemical agent for the treatment of reticular veins .
BACKGROUND	ClinicalTrials.gov Identifier : NCT02054325 , 3/02/2014 .

###24845395
OBJECTIVE	This study aims to qualitatively evaluate the feasibility of using a pragmatic network of community-based Tai Chi schools to deliver 9-month exercise interventions to women with osteopenia and to explore the impact of this design feature on facilitators and barriers to trial recruitment and participant adherence during and after the trial .
METHODS	In a randomized trial comparing 9 months of Tai Chi plus usual care with usual care alone for postmenopausal women with moderately low bone mass , exit interviews were conducted with 43 participants randomized to the pragmatically delivered Tai Chi intervention .
METHODS	Transcripts were digitially recorded , transcribed , and imported into NVivo , a computer-assisted qualitative data analysis software .
METHODS	Qualitative content analysis was used to code the data .
METHODS	Patterns emerging from among the codes were further examined and clustered into themes .
RESULTS	Analyses revealed features of pragmatically delivered Tai Chi programs that both facilitated and impeded study participation and/or posttrial adherence .
RESULTS	Direct facilitators included convenience of class locations and times , alternative learning modalities , quality of teaching , community and social support , and perceived health benefits .
RESULTS	Barriers consisted primarily of time-related issues .
RESULTS	A possible causal mechanism ( self-efficacy ) was also identified .
CONCLUSIONS	Factors related to the use of pragmatically delivered interventions are beneficial for fostering both study participation and posttrial adherence to the Tai Chi programs .
CONCLUSIONS	This qualitative substudy is valuable for identifying these factors and a possible causal mechanism .
CONCLUSIONS	These findings will assist in the design and conduct of future studies exploring the use of Tai Chi in fracture prevention and health-related quality of life in postmenopausal women .

###25403306
OBJECTIVE	To study the characteristics of asthenic syndrome in elderly people after acute respiratory viral infection .
METHODS	We examined 87 patients with chronic cerebral ischemia and other comorbid disorders , aged from 63 to 78 years .
METHODS	Patients were randomized to two groups .
METHODS	Patients of the main group received mexidol ( 1 tablet ( 125 mg ) 3 times a day during 3 weeks ) along with standard treatment .
METHODS	Patients of the control group received standard treatment only .
METHODS	All patients underwent neuropsychological testing for the assessment of symptoms of asthenic syndrome .
CONCLUSIONS	A comparative analysis of the patient 's condition in both groups has demonstrated a reduction in symptoms of asthenia , autonomic lability and cognitive deficit in patients treated with mexidol .

###25270776
BACKGROUND	Exercise at altitude places additional physiological stress on the individual in comparison with sea-level performance .
BACKGROUND	This study examines the effect of a moderate hypoxic environment ( FiO2 = ~ 17 % ) on intermittent sprint exercise performance .
METHODS	Nine male games players completed two consecutive sets of a 40 minute cycling intermittent sprint protocol ( CISP2 ) in a hypoxic ( HYP ; FiO2 = ~ 17 % ) and normoxic ( NORM ; FiO2 = ~ 21 % ) environment .
METHODS	During each sprint peak power output ( PPO ; the highest power during each 5 s sprint ) , mean power output ( MPO ; the average power during the 3 s sprint ) were measured and total work done ( WD ; force applied from the highest 3 s period of power output ) was calculated .
METHODS	Physiological responses were recorded throughout the testing procedure .
RESULTS	Reductions were found in PPO ( 944155 vs. 983167 W ) , MPO ( 900176 vs. 853177 W ) and WD ( 10220 vs. 10820 kJ ) during the CISP2 ( P < 0.05 ) at HYP compared to NORM .
RESULTS	Reductions in PPO , MPO and WD were also found between the 1st half and 2nd half CISP ( P < 0.05 ) and there was a greater decline from the 1st half CISP to the 2nd half CISP in PPO , MPO and WD at HYP .
RESULTS	Heart rate was higher and peripheral arterial oxygen saturation lower during HYP compared to NORM ( P < 0.05 ) .
CONCLUSIONS	Moderate hypoxia significantly reduced PPO ( ~ 4 % ) , MPO ( ~ 5 % ) and WD ( ~ 5 % ) compared to normoxia .
CONCLUSIONS	The results suggest athletes will be at a disadvantage when performing intermittent sprinting at moderate altitude .

###25836986
OBJECTIVE	Several case series have reported the effects of fecal microbiota transplantation ( FMT ) for ulcerative colitis ( UC ) .
OBJECTIVE	We assessed the efficacy and safety of FMT for patients with UC in a double-blind randomized trial .
METHODS	Patients with mild to moderately active UC ( n = 50 ) were assigned to groups that underwent FMT with feces from healthy donors or were given autologous fecal microbiota ( control ) ; each transplant was administered via nasoduodenal tube at the start of the study and 3 weeks later .
METHODS	The study was performed at the Academic Medical Center in Amsterdam from June 2011 through May 2014 .
METHODS	The composite primary end point was clinical remission ( simple clinical colitis activity index scores 2 ) combined with 1-point decrease in the Mayo endoscopic score at week 12 .
METHODS	Secondary end points were safety and microbiota composition by phylogenetic microarray in fecal samples .
RESULTS	Thirty-seven patients completed the primary end point assessment .
RESULTS	In the intention-to-treat analysis , 7 of 23 patients who received fecal transplants from healthy donors ( 30.4 % ) and 5 of 25 controls ( 20.0 % ) achieved the primary end point ( P = .51 ) .
RESULTS	In the per-protocol analysis , 7 of 17 patients who received fecal transplants from healthy donors ( 41.2 % ) and 5 of 20 controls ( 25.0 % ) achieved the primary end point ( P = .29 ) .
RESULTS	Serious adverse events occurred in 4 patients ( 2 in the FMT group ) , but these were not considered to be related to the FMT .
RESULTS	At 12 weeks , the microbiota of responders in the FMT group was similar to that of their healthy donors ; remission was associated with proportions of Clostridium clusters IV and XIVa .
CONCLUSIONS	In this phase 2 trial , there was no statistically significant difference in clinical and endoscopic remission between patients with UC who received fecal transplants from healthy donors and those who received their own fecal microbiota , which may be due to limited numbers .
CONCLUSIONS	However , the microbiota of responders had distinct features from that of nonresponders , warranting further study .
CONCLUSIONS	ClinicalTrials.gov Number : NCT01650038 .

###24305422
BACKGROUND	Even facial pigmentation is considered a universal sign of youth and beauty in all cultures and at all ages in both men and women .
BACKGROUND	The recent FDA concern about the safety of topical hydroquinone has provided the impetus for research into new pigment lightening alternatives in the cosmetic OTC market .
OBJECTIVE	This research examined a novel hydroxyphenoxy propionic acid , ellagic acid , yeast extract , and salicylic acid formulation applied twice daily compared to the standard prescription combination of 4 % hydroquinone cream and 0.025 % tretinoin cream applied nightly .
METHODS	This single-center investigator-blinded 12week study enrolled 82 subjects ( 7 male , 75 female ) ages 25-60years divided into 2 balanced groups of 41 subjects each with one group using a novel hydroxyphenoxy propionic acid , ellagic acid , yeast extract , and salicylic acid formulation applied twice daily compared to the standard prescription combination of 4 % hydroquinone cream and 0.025 % tretinoin cream applied nightly .
RESULTS	Significant tolerability issues arose with the prescription combinations that were not seen with the cosmetic formulation .
RESULTS	In terms of ability to even skin tone , decrease spot intensity , decrease spot size , and improve overall pigmentation , both products demonstrated parity .
CONCLUSIONS	This research demonstrated the value of cosmetic formulations as part of a treatment regimen for pigmentation issues .

###24886549
BACKGROUND	Studies all over the world reported that smoking relapses occur during the first two weeks after a quit date .
BACKGROUND	The current study aimed to assess the impact of the additional phone calls counselling during the first month on the abstinence rate at 3 and 6months after quit date among smokers in Penang , Malaysia .
METHODS	The study was conducted at Quit Smoking Clinic of two major hospitals in Penang , Malaysia .
METHODS	All the eligible smokers who attended the clinics between February 1st and October 31st 2012 were invited .
METHODS	Participants were randomly assigned by using urn design method either to receive the usual care that followed in the clinics ( control ) or the usual care procedure plus extra counselling sessions through phone calls during the first month of quit attempt ( intervention ) .
RESULTS	Participants in our cohort smoked about 14 cigarettes per day on average ( mean = 13.787.0 ) .
RESULTS	At 3months , control group was less likely to quit smoking compared to intervention group ( 36.9 % vs. 46.7 % , verified smoking status ) but this did not reach statistical significance ( OR = 0.669 ; 95 % CI = 0.395-1 .133 , P = 0.86 ) .
RESULTS	However , at 6months , 71.7 % of the intervention group were successfully quit smoking ( bio-chemically verified ) compared to 48.6 % of the control group ( P < 0.001 ) .
RESULTS	The control group were significantly less likely to quit smoking ( OR = 0.375 ; 95 % CI = 0.217-0 .645 , P < 0.001 ) .
CONCLUSIONS	Smoking cessation intervention consisting of phone calls counselling delivered during the first month of quit attempt revealed significantly higher abstinence rates compared with a standard care approach .
CONCLUSIONS	Therefore , the additional counselling in the first few weeks after stop smoking is a promising treatment strategy that should be evaluated further .
BACKGROUND	TCTR20140504001 .

###25418218
BACKGROUND	Many methods reportedly prevent contrast-induced nephropathy ( CIN ) , but the effect of brain natriuretic peptide ( BNP ) on CIN is unknown .
BACKGROUND	In this study we investigated recombinant BNP use before coronary angiography ( CA ) or nonemergent percutaneous coronary intervention ( PCI ) in patients with unstable angina .
METHODS	One thousand patients with unstable angina were prospectively evaluated .
METHODS	The patients were randomly assigned to : group A , isotonic normal saline ( NaCl 0.9 % , 1 mL/kg/h ) for 24 hours before CA or PCI ; and group B , human recombinant BNP ( rhBNP ; 0.005 g/kg/min ) .
METHODS	Serum creatinine ( Scr ) levels and estimated glomerular filtration rate were measured before and 24 , 48 , and 72 hours , and 7 days after the procedure .
METHODS	The primary outcome was CIN incidence defined according to a relative ( 25 % ) or absolute ( 0.5 mg/dL and 44 mol/L , respectively ) increase in Scr from baseline within 48 hours .
METHODS	The secondary end points were the changes in the Scr and estimated glomerular filtration rate , before and after the procedure .
RESULTS	Contrast volume , a history of diabetes mellitus , and BNP administration independently predicted CIN .
RESULTS	The incidence of CIN was significantly greater in group A than in group B ( 14.8 % vs 5.6 % ; P < 0.01 ) .
RESULTS	Renal function was less compromised in patients who received rhBNP .
RESULTS	The Scr of all patients with CIN remained increased for 24 hours , but it was lower and recovered faster in patients who received rhBNP .
CONCLUSIONS	rhBNP administration before CA or PCI protects renal function and can significantly decrease CIN incidence .

###24620666
OBJECTIVE	To investigate the effect of aerobic exercise on immune factor IL-4 , TNF-alpha in patients with allergic rhinitis , which provide a theoretical basis for the treatment of allergic rhinitis .
METHODS	Thirty-two allergic rhinitis patients were selected and divided into a control group ( 14 people ) and the experimental group ( 18 people ) .
METHODS	During the treatment , both groups receive conventional symptomatic treatment .
METHODS	Meanwhile , aerobic exercise therapy is applied to the experimental group for 40 - 60 minutes a day , 3 - 4 days a week .
METHODS	Serum IL-4 , TNF-alpha and allergic rhinitis symptoms graded scoring were tested before and after 6 month therapy .
RESULTS	After six months of exercise intervention , the 11-4 , and TNF-alpha levels of experimental group were significantly lower than the level of control group .
RESULTS	The symptoms score is also significantly decreased in experimental group .
CONCLUSIONS	Aerobic exercise had good therapeutic effect in patients with allergic rhinitis .
CONCLUSIONS	The mechanism may be that aerobic exercise can reduce the level of IL-4 and TNF-alpha , which can relieve infiltration and activation of inflammatory cells .

###25611582
OBJECTIVE	To examine the impact of a pre-bariatric surgery physical activity intervention ( PAI ) , designed to increase bout-related ( 10 min ) moderate to vigorous PA ( MVPA ) , on health-related quality of life ( HRQoL ) .
METHODS	Analyses included 75 adult participants ( 86.7 % female ; BMI = 45.0 6.5 kg m ( -2 ) ) who were randomly assigned to 6 weeks of PAI ( n = 40 ) or standard pre-surgical care ( SC ; n = 35 ) .
METHODS	PAI received 6 individual weekly counseling sessions to increase walking exercise .
METHODS	Participants wore an objective PA monitor for 7 days and completed the SF-36 Health Survey at baseline and post-intervention to evaluate bout-related MVPA and HRQoL changes , respectively .
RESULTS	PAI increased bout-related MVPA from baseline to post-intervention ( 4.4 5.5 to 21.0 21.4 min day ( -1 ) ) versus no change ( 7.9 16.6 to 7.6 11.5 min day ( -1 ) ) for SC ( P = 0.001 ) .
RESULTS	PAI reported greater improvements than SC on all SF-36 physical and mental scales ( P < 0.05 ) , except role-emotional .
RESULTS	In PAI , better baseline scores on the physical function and general health scales predicted greater bout-related MVPA increases ( P < 0.05 ) , and greater bout-related MVPA increases were associated with greater post-intervention improvements on the physical function , bodily pain , and general health scales ( P < 0.05 ) .
CONCLUSIONS	Increasing PA preoperatively improves physical and mental HRQoL in bariatric surgery candidates .
CONCLUSIONS	Future studies should examine whether this effect improves surgical safety , weight loss outcomes , and postoperative HRQoL .

###25652579
BACKGROUND	Insomnia is a significant risk factor for depression onset , can result in more disabling depressive illness , and is a common residual symptom following treatment cessation that can increase the risk of relapse .
BACKGROUND	Internet-based cognitive behavioural therapy for insomnia has demonstrated efficacy and acceptability to men who are less likely than women to seek help in standard care .
BACKGROUND	We aim to evaluate whether internet delivered cognitive behavioural therapy for insomnia as an adjunct to a standard depression therapeutic plan can lead to improved mood outcomes .
METHODS	Male participants aged 50 years or more , meeting Diagnostic and Statistical Manual of Mental Disorders criteria for current Major Depressive Episode and/or Dysthymia and self-reported insomnia symptoms , will be screened to participate in a single-centre double-blind randomised controlled trial with two parallel groups involving adjunctive internet-delivered cognitive behavioural therapy for insomnia and an internet-based control program .
METHODS	The trial will consist of a nine-week insomnia intervention period with a six-month follow-up period .
METHODS	During the insomnia intervention period participants will have their depression management coordinated by a psychiatrist using standard guideline-based depression treatments .
METHODS	The study will be conducted in urban New South Wales , Australia , where 80 participants from primary and secondary care and direct from the local community will be recruited .
METHODS	The primary outcome is change in the severity of depressive symptoms from baseline to week 12 .
CONCLUSIONS	This study will provide evidence on whether a widely accessible , evidence-based , internet-delivered cognitive behavioural therapy for insomnia intervention can lead to greater improvements than standard treatment for depression alone , in a group who traditionally do not readily access psychotherapy .
CONCLUSIONS	The study is designed to establish effect size , feasibility and processes associated with implementing e-health solutions alongside standard clinical care , to warrant undertaking a larger more definitive clinical trial .
BACKGROUND	Australian and New Zealand Clinical Trials Registry ACTRN12612000985886 .

###25253123
BACKGROUND	In acute cough patients , impaired lung function as present in chronic lung conditions like asthma and chronic obstructive pulmonary disease ( COPD ) are often thought to negatively influence course of disease , but clear evidence is lacking .
OBJECTIVE	To investigate the influence of lung function abnormalities on course of disease and response to antibiotic therapy in primary care patients with acute cough .
METHODS	A total of 3,104 patients with acute cough ( 28 days ) were included in a prospective observational study with a within-nested trial , of which 2,427 underwent spirometry 28-35 days after inclusion .
METHODS	Influence of the lung function abnormalities fixed obstruction ( forced expiratory volume in 1s ( FEV1 ) / forced vital capacity ( FVC ) ratio < 0.7 ) and bronchodilator responsiveness ( FEV1 increase of 12 % or 200ml after 400g salbutamol ) on symptom severity , duration and worsening were evaluated using uni - and multivariable regression models .
METHODS	Antibiotic use was defined as the reported use of antibiotics 5 days in the first week .
METHODS	Interaction terms were calculated to investigate modifying effects of lung function on antibiotic effect .
RESULTS	The only significant association was the effect of severe airway obstruction on symptom severity on days 2-4 ( difference = 0.31 , 95 % confidence interval ( CI ) = 0.03-0 .60 , P = 0.03 ) .
RESULTS	No evidence of a differential effect of lung function on the effect of antibiotics was found .
RESULTS	Prior use of inhaled steroids was associated with a 30 % slower resolution of symptoms rated ` moderately bad ' or worse ( hazard ratio = 0.75 , 95 % CI = 0.63-0 .90 , P = 0.00 ) .
CONCLUSIONS	In adult patients with acute cough , lung function abnormalities were neither significantly associated with course of disease nor did they modify the effect of antibiotics .

###25586473
OBJECTIVE	To determine whether an avatar-based , online , self-management program is an effective therapeutic approach for women with overactive bladder ( OAB ) .
OBJECTIVE	OAB is a highly prevalent symptom complex that significantly impacts health-related quality of life ( HRQOL ) .
OBJECTIVE	Behavioral interventions can produce substantial improvement in symptoms and HRQOL .
OBJECTIVE	Online education programs offer patients with OAB an alternative to face-to-face self-management instruction .
OBJECTIVE	Evidence suggests that avatars ( digital humans ) embedded into online programs may help persuade and motivate patients to adopt healthy behaviors .
METHODS	In a 12-week , randomized , controlled trial , women ( aged > 55 years ) with symptoms of OAB for at least 3 months were randomized to 2 versions of a 3-part , online , self-management program .
METHODS	After collecting the baseline metrics , the intervention group viewed a generic avatar coach with a self-avatar peer mentor designed to resemble the participant , and the control group viewed the identical online program with voice only .
METHODS	Participants viewed part 1 at week 1 and parts 2 and 3 at week 6 .
METHODS	Participants completed daily bladder diaries throughout the 12-week period and OAB-related outcome measures at weeks 1 , 6 , and 12 .
RESULTS	Forty-one women completed the study ( mean age = 61 years , standard deviation = 6 ) .
RESULTS	The analysis of covariance of week-12 outcome measures with the baseline as covariates demonstrated significant improvements in the intervention group in OAB questionnaire HRQOL ( P = .02 ; large effect ) , 24-hour frequency ( P < .001 ; large effect ) , night-time urination ( P < .001 ; large effect ) , urgency ( P < .001 ; large effect ) , and urge incontinence ( P < .001 ; large effect ) .
CONCLUSIONS	An avatar-based intervention embedded into an online self-management program improved OAB HRQOL and symptoms in women .

###25406657
BACKGROUND	Pharmacokinetic interactions between rifampicin and protease inhibitors ( PIs ) complicate the management of HIV-associated tuberculosis .
BACKGROUND	Rifabutin is an alternative rifamycin , for patients requiring PIs .
BACKGROUND	Recently some international guidelines have recommended a higher dose of rifabutin ( 150mg daily ) in combination with boosted lopinavir ( LPV/r ) , than the previous dose of rifabutin ( 150mg three times weekly { tiw } ) .
BACKGROUND	But there are limited pharmacokinetic data evaluating the higher dose of rifabutin in combination with LPV/r .
BACKGROUND	Sub-optimal dosing can lead to acquired rifamycin resistance ( ARR ) .
BACKGROUND	The plasma concentration of 25-O-desacetylrifabutin ( d-RBT ) , the metabolite of rifabutin , increases in the presence of PIs and may lead to toxicity .
RESULTS	Sixteen patients with TB-HIV co-infection received rifabutin 300mg QD in combination with tuberculosis chemotherapy ( initially pyrazinamide , isoniazid and ethambutol then only isoniazid ) , and were then randomized to receive isoniazid and LPV/r based ART with rifabutin 150mg tiw or rifabutin 150mg daily .
RESULTS	The rifabutin dose with ART was switched after 1month .
RESULTS	Serial rifabutin and d-RBT concentrations were measured after 4weeks of each treatment .
RESULTS	The median AUC0-48 and Cmax of rifabutin in patients taking 150mg rifabutin tiw was significantly reduced compared to the other treatment arms .
RESULTS	Geometric mean ratio ( 90 % CI ) for AUC0-48 and Cmax was 0.6 ( 0.5-0 .7 ) and 0.5 ( 0.4-0 .6 ) for RBT 150mg tiw compared with RBT 300mg and 0.4 ( 0.4-0 .4 ) and 0.5 ( 0.5-0 .6 ) for RBT 150mg tiw compared with 150mg daily .
RESULTS	86 % of patients on the tiw rifabutin arm had an AUC0-24 < 4.5 g.h / mL , which has previously been associated with acquired rifamycin resistance ( ARR ) .
RESULTS	Plasma d-RBT concentrations increased 5-fold with tiw rifabutin dosing and 15-fold with daily doses of rifabutin .
RESULTS	Rifabutin was well tolerated at all doses and there were no grade 4 laboratory toxicities .
RESULTS	One case of uveitis ( grade 4 ) , occurred in a patient taking rifabutin 300mg daily prior to starting ART , and grade 3 neutropenia ( asymptomatic ) was reported in 4 patients .
RESULTS	These events were not associated with increases in rifabutin or metabolite concentrations .
CONCLUSIONS	A daily 150mg dose of rifabutin in combination with LPV/r safely maintained rifabutin plasma concentrations in line with those shown to prevent ARR .
BACKGROUND	ClinicalTrials.gov Identifier : NCT00640887 .

###25025057
BACKGROUND	Oats are high in soluble fibers and effective in reducing the risk of cardiovascular diseases ( CVD ) .
BACKGROUND	We assessed the effects of beta-glucan from oat bran on serum nitric oxide ( NO ) endothelial function in patients with hypercholesterolemia .
METHODS	Sixty hypercholesterolemic patients were randomly divided to receive an experimental bread rich in beta-glucan from oat bran ( intervention ) or bread rich in wheat fiber ( control ) for four weeks .
METHODS	All subjects had the same diet for two-week baseline period and hypocaloric diet for four weeks of intervention .
METHODS	Serum NO concentration and flow-mediated dilation ( FMD ) were determined before and after the experiment .
RESULTS	Mean age of the participants was 51.1 9.3 years and 65 % ( n = 39 ) were female .
RESULTS	After intervention , serum NO concentration increased by 50.2 19.8 mol/lit in the intervention group ( P = 0.017 ) , but no change was observed in the control group ( 17.5 27.5 mol/lit ; P = 0.530 ) .
RESULTS	No change of FMD was observed in the intervention ( 0.48 0.78 % ; P = 0.546 ) or in the control group ( 0.59 0.92 % ; P = 0.533 ) .
CONCLUSIONS	Consumption of oat bread for four weeks increases serum NO concentration but has no effect on FMD .
CONCLUSIONS	Further studies are warranted in this regard .

###25149295
OBJECTIVE	To compare two regimens of reduced bowel preparation and faecal tagging for CT colonography .
METHODS	Single centre , prospective , randomized , noninferiority study , in which 52 consecutive adults underwent routine CT colonography .
METHODS	Patients , following a three-day low-fibre diet , received one of the two reduced preparations : 1-L polyethylene glycol and four tablets of bisacodyl in association with 90 mL of Iopamidol for faecal tagging administered on the same day as CTC examination ( group 1 ) ; or a standard `` iodine-only '' preparation , consisting in 180 ml of Iopamidol the day before the examination ( group 2 ) .
METHODS	Primary outcome was the overall quality of bowel preparation .
RESULTS	Twenty-six patients per group were included .
RESULTS	Per segment analysis showed preparation of diagnostic quality in 97.4 % of segments in group 1 and in 95.5 % in group 2 ( p = ns ) .
RESULTS	Per-patient analysis showed optimal quality of preparation in 76.9 % of patients in group 1 and in 84.6 % in group 2 ( p = ns ) .
RESULTS	Patient tolerability to both preparations was not different .
CONCLUSIONS	A limited bowel preparation consisting of 1-L PEG and four tablets of bisacodyl in association with 90 mL of Iodine for faecal tagging administered on the same day as CTC examination is feasible and offers bowel cleansing comparable to `` iodine-only '' preparation .
CONCLUSIONS	Low-dose PEG bisacodyl and Iopamidol preparation is feasible , providing adequate bowel cleansing .
CONCLUSIONS	Faecal tagging is not different from the two limited preparations .
CONCLUSIONS	Patient tolerability to the two colon cleansing regimens is similar .

###25740743
OBJECTIVE	This study aims to determine the impact of increasing polyunsaturated fatty acid intake on blood glucose , lipid metabolism , and pregnancy outcomes of pregnant women with gestational diabetes mellitus .
METHODS	Under constant total energy and protein intake , 84 pregnant women with gestational diabetes mellitus were randomly divided into the experimental and control groups , which were given oil-rich and conventional low-oil meals , respectively .
RESULTS	After the dietary intervention , the intake and energy supply of fat and the three fatty acids were significantly higher in the experimental group than the control group ( p < 0.001 ) .
RESULTS	The intake and energy supply of polyunsaturated fatty acids increased significantly post-intervention in the experimental group but did not change in the control group .
RESULTS	In both the intervention and the control group , fasting blood glucose , 2 h postprandial plasma glucose , and the insulin resistance index decreased significantly post-intervention ( p < 0.05 ) ; the lipid changes were consistent between groups .
RESULTS	Pregnancy outcomes did not differ significantly between the two groups ( p > 0.05 ) .
CONCLUSIONS	An appropriate increase in polyunsaturated fatty acid intake benefits pregnant women with gestational diabetes mellitus as well as fetuses , as long as the diet therapy follows basic recommendations and total energy intake is strictly controlled .

###24436240
OBJECTIVE	Hypothermia improves outcome in resuscitated patients and newborns with hypoxic brain injury .
OBJECTIVE	We studied the safety and feasibility of mild hypothermia in awake patients with stroke after intravenous thrombolysis .
METHODS	Patients were randomized 1:1 to mild hypothermia ( 35C ) or to standard stroke unit care within 6 hours of symptom onset .
METHODS	Hypothermia was induced with a surface-cooling device and cold saline infusions .
METHODS	Active cooling was restrained gradually after 12 hours at < 35.5 C.
METHODS	The primary outcome measure was the number of patients with < 36C body temperature for > 80 % of the 12-hour cooling period .
RESULTS	We included 36 patients with a median of National Institutes of Health Stroke Scale score of 9 one hour after thrombolysis .
RESULTS	Fifteen of 18 ( 83 % ) patients achieved the primary end point .
RESULTS	Sixteen ( 89 % ) patients reached < 35.5 C in a median time of 10 hours ( range , 7-16 hours ) from symptom onset , spent 10.5 hours ( 1-17 hours ) in hypothermia , and were back to normothermia in 23 hours ( 15-29 hours ) .
RESULTS	Few serious adverse events were more common in the hypothermia group .
RESULTS	At 3 months , 7 patients ( 39 % ) in both groups had good outcome ( modified Ranking Scale , 0-2 ) , whereas poor outcome ( modified Ranking Scale , 4-6 ) was twice as common in the normothermia group ( 44 % versus 22 % ) .
CONCLUSIONS	Mild hypothermia with a surface-cooling device in an acute stroke unit is safe and feasible in thrombolyzed , spontaneously breathing patients with stroke , despite the adverse events .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00987922 .

###24995962
OBJECTIVE	In patients with ulcerative colitis ( UC ) , colonoscopy is an essential procedure for evaluating mucosal damage , and treatment outcomes .
OBJECTIVE	A new flexible ultrathin colonoscope ( PCF-PQ260 ) has been developed to readily pass through tortuous and narrow lesions of the colon and cause minimum patient discomfort .
OBJECTIVE	The objective of the present study was to evaluate the comfort and performance of this new type of scope in UC patients who underwent colonoscopy for estimation of mucosal inflammation , basically without sedation .
METHODS	In a prospective , single-center setting , among 107 UC patients who were to undergo colonoscopy , 84 eligible cases were randomly assigned to the new ultrathin flexible colonoscope , PCF-PQ260 ( n = 42 ) or to a conventional colonoscope , PCF-Q260A ( n = 42 ) .
METHODS	Main outcome measure was patient pain level determined by visual analogue scale ( VAS ) with 0 = none , and 100 = extremely painful .
METHODS	Other outcomes were cecal intubation time , rate of complete intubation ( to reach the cecum ) and rate of procedural complications .
RESULTS	VAS score was significantly lower in the new-scope group as compared with the conventional-scope group : meanSD , median ( range ) : 19.316.9 , 14 ( 0-62 ) vs 32.021.6 , 31.8 ( 0-100 , P = 0.005 ) .
RESULTS	However , cecal intubation rate ( 97.6 % ) and time ( 4min ) were similar in the two groups .
RESULTS	There was no procedure-related serious complication in either group .
CONCLUSIONS	The findings indicated that the flexible ultrathin colonoscope PCF-PQ260 has significantly better tolerability in UC patients compared to a conventional colonoscope .

###25030621
BACKGROUND	In a pan-European randomised controlled trial ( GRACE INTRO ) of two interventions , ( i ) a point-of-care C-reactive protein test and/or ( ii ) training in communication skills and use of an interactive patient booklet , both interventions resulted in large reductions in antibiotic prescribing for acute cough .
OBJECTIVE	This process evaluation explored patients ' views of primary care consultations using the two interventions in six European countries .
METHODS	Sixty-two interviews were conducted with patients who had participated in the GRACE INTRO trial .
METHODS	Interviews were transcribed verbatim and translated into English where necessary .
METHODS	Analysis used techniques from thematic and framework analysis .
RESULTS	Most patients were satisfied with their consultation despite many not receiving an antibiotic .
RESULTS	Patients appeared to accept the use of both intervention approaches .
RESULTS	A minority , but particularly in the trial arm with both interventions , reported that they would wait longer before consulting for cough in future .
CONCLUSIONS	Patients perceived that both interventions supported the general practitioner 's ( GP 's ) prescribing decisions by helping them understand when an antibiotic was , and was not , needed .
CONCLUSIONS	Patients consulting with acute cough had largely positive views about the GP 's enhanced communication skills , which included understanding their concerns , and the use of a near-patient test as an additional investigation .

###25238728
OBJECTIVE	Prior analysis in the Open vs Endovascular Repair Veterans Affairs ( VA ) Cooperative Study ( CSP # 498 ) demonstrated that survival , quality of life , and total health care costs are not significantly different between the open and endovascular methods of repair of abdominal aortic aneurysm .
OBJECTIVE	The device is a major cost of this method of repair , and the objective of this study was to evaluate the costs of the device , abdominal aortic aneurysm repair , and total health care costs when different endograft systems are selected for the endovascular repair ( EVR ) .
OBJECTIVE	Within each selected system , EVR costs are compared with open repair costs .
METHODS	The study randomized 881 patients to open ( n = 437 ) or EVR ( n = 444 ) .
METHODS	Device selection was recorded before randomization ; therefore , open repair controls were matched to each device cohort .
METHODS	Data were excluded for two low-volume devices , implanted in only 13 individuals , leaving 423 control and 431 endovascular patients : 166 Zenith ( Cook Medical , Bloomington , Ind ) , 177 Excluder ( W. L. Gore & Associates , Flagstaff , Ariz ) , and 88 AneuRx ( Medtronic , Minneapolis , Minn ) .
METHODS	Mean device , hospitalization , and total health care costs from randomization to 2 years were compared .
METHODS	Health care utilization data were obtained from patients and national VA and Medicare data sources .
METHODS	VA costs were determined using methods previously developed by the VA Health Economics Resource Center .
METHODS	Non-VA costs were obtained from Medicare claims data and billing data from the patient 's health care providers .
RESULTS	Implant costs were 38 % of initial hospitalization costs .
RESULTS	Mean device ( range , $ 13,600 - $ 14,400 ) , initial hospitalization ( range , $ 34,800 - $ 38,900 ) , and total health care costs at 2 years in the endovascular ( range , $ 72,400 - $ 78,200 ) and open repair groups ( range , $ 75,600 - $ 82,100 ) were not significantly different among device systems .
RESULTS	Differences between endovascular and corresponding open repair cohorts showed lower mean costs for EVR ( range , $ 3200 - $ 8300 ) , but these were not statistically different .
CONCLUSIONS	The implant costs of endovascular aneurysm repair are substantial .
CONCLUSIONS	When evaluating total health care system expenditures , there is large individual variability in costs , and there is no significant difference at 2 years among systems or when an individual system is compared with open repair .

###24703722
BACKGROUND	Itolizumab , a humanized monoclonal antibody to CD6 , is a novel therapeutic agent evaluated in chronic plaque psoriasis .
OBJECTIVE	We sought to assess the safety and efficacy of itolizumab in moderate to severe chronic plaque psoriasis .
METHODS	A total of 225 patients were randomized ( 2:2:1 ) to 2 different itolizumab arms ( A or B ; A = 4-week loading dose of 0.4 mg/kg/wk followed by 1.6 mg/kg every 2 weeks ; B = 1.6 / mg every 2 weeks ) or placebo .
METHODS	At week 12 , the placebo arm was switched to 1.6 mg/kg itolizumab every 2 weeks .
METHODS	The primary end point was the proportion of patients with at least 75 % improvement in Psoriasis Area and Severity Index score at week 12 .
RESULTS	At week 12 , 27.0 % in arm A ( P = .0172 vs placebo ) , 36.4 % in B ( P = .0043 vs placebo ) , and 2.3 % in the placebo arm had at least 75 % improvement in Psoriasis Area and Severity Index score .
RESULTS	At week 28 , the proportion with at least 75 % improvement in Psoriasis Area and Severity Index score was comparable : 46.1 % , 45.5 % , and 41.9 % for A , B , and placebo , respectively .
RESULTS	In weeks 1 to 12 , the incidence of all adverse events was comparable across arms ( A , 43 % ; B , 38 % ; placebo , 47 % ) and the incidence of infections was not greater than placebo ( 11.1 % , 8.9 % , and 18.6 % for A , B , and placebo ) .
CONCLUSIONS	No active comparator is a limitation .
CONCLUSIONS	Itolizumab is an effective and well-tolerated novel biological therapy in moderate to severe psoriasis .

###26144908
BACKGROUND	Unlike most chronic diseases , osteoporosis treatments are generally limited to a single drug at a fixed dose and frequency .
BACKGROUND	Nonetheless , no approved therapy is able to restore skeletal integrity in most osteoporotic patients and the long-term use of osteoporosis drugs is controversial .
BACKGROUND	Thus , many patients are treated with the sequential use of two or more therapies .
BACKGROUND	The DATA study showed that combined teriparatide and denosumab increased bone mineral density more than either drug alone .
BACKGROUND	Discontinuing teriparatide and denosumab , however , results in rapidly declining bone mineral density .
BACKGROUND	In this DATA-Switch study , we aimed to assess the changes in bone mineral density in postmenopausal osteoporotic women who transitioned between treatments .
METHODS	This randomised controlled trial ( DATA-Switch ) is a preplanned extension of the denosumab and teriparatide administration study ( DATA ) , in which 94 postmenopausal osteoporotic women were randomly assigned to receive 24 months of teriparatide ( 20 mg daily ) , denosumab ( 60 mg every 6 months ) , or both drugs .
METHODS	In DATA-Switch , women originally assigned to teriparatide received denosumab ( teriparatide to denosumab group ) , those originally assigned to denosumab received teriparatide ( denosumab to teriparatide group ) , and those originally assigned to both received an additional 24 months of denosumab alone ( combination to denosumab group ) .
METHODS	Bone mineral density at the spine , hip , and wrist were measured 6 months , 12 months , 18 months , and 24 months after the drug transitions as were biochemical markers of bone turnover .
METHODS	The primary endpoint was the percent change in posterior-anterior spine bone mineral density over 4 years .
METHODS	Between-group changes were assessed by one-way analysis of variance in our modified intention-to-treat population .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00926380 .
RESULTS	Between Sept 27 , 2011 , and Jan 28 , 2013 , eligible women from the DATA study were enrolled into DATA-Switch .
RESULTS	Of 83 potential enrollees from the DATA study , 77 completed at least one post-baseline visit .
RESULTS	After 48 months , the primary outcome of mean spine bone mineral density increased by 183 % ( 95 % CI 149-218 ) in 27 women in the teriparatide to denosumab group , 140 % ( 109-172 ) in 27 women the denosumab to teriparatide group , and 160 % ( 140-180 ) in 23 women in the combination to denosumab group , although this increase did not differ significantly between groups ( for between-group comparisons , p = 013 for the teriparatide to denosumab group vs the denosumab to teriparatide group , p = 030 for the teriparatide to denosumab group vs the combination to denosumab group , and p = 041 for the denosumab to teriparatide group vs the combination to denosumab group ) .
RESULTS	For the bone mineral density secondary outcomes , total hip bone mineral density increased more in the teriparatide to denosumab group ( 66 % [ 95 % CI 53-79 ] ) than in the denosumab to teriparatide group ( 28 % [ 13-42 ] , p = 00002 ) , but had the greatest increase in the combination to denosumab group ( 86 % [ 71-100 ] ; p = 00446 vs the teriparatide to denosumab group , p < 00001 vs the denosumab to teriparatide group ) .
RESULTS	Similarly , femoral neck bone mineral density increased more in the teriparatide to denosumab group ( 83 % [ 95 % CI 61-105 ] ) and the combination to denosumab group ( 91 % [ 61-120 ] ) than in the denosumab to teriparatide group ( 49 % [ 22-75 ] ; p = 00447 for teriparatide to denosumab vs denosumab to teriparatide , p = 00336 for combination to denosumab vs denosumab to teriparatide ) .
RESULTS	Differences between the combination to denosumab group and the teriparatide to denosumab group did not differ significantly ( p = 067 ) .
RESULTS	After 48 months , radius bone mineral density was unchanged in the teriparatide to denosumab group ( 00 % [ 95 % CI -13 to 14 ] ) , whereas it decreased by -18 % ( -50 to 13 ) in the denosumab to teriparatide group , and increased by 28 % ( 12-44 ) in the combination to denosumab group ( p = 00075 for the teriparatide to denosumab group vs the combination to denosumab group ; p = 00099 for the denosumab to teriparatide group vs the combination to denosumab group ) .
RESULTS	One participant in the denosumab to teriparatide group had nephrolithiasis , classified as being possibly related to treatment .
CONCLUSIONS	In postmenopausal osteoporotic women switching from teriparatide to denosumab , bone mineral density continued to increase , whereas switching from denosumab to teriparatide results in progressive or transient bone loss .
CONCLUSIONS	These results should be considered when choosing the initial and subsequent management of postmenopausal osteoporotic patients .
BACKGROUND	Amgen , Eli Lilly , and National Institutes of Health .

###25636822
BACKGROUND	Previous evaluations of the SunSmart Program have supported the link between a written sun protection policy and improved sun protection behaviours in New South Wales ( NSW ) primary schools .
BACKGROUND	However these evaluations have relied on self-reported data and research suggests that direct observations are required to better represent schools ' usual sun protective practices .
METHODS	Data will be collected in the summer months of 2014 , 2015 , and 2016 as part of an 18-month cluster-controlled trial in NSW primary schools ( n = 20 ) .
METHODS	Researchers will conduct three direct observations to record students ' hat use and teachers ' use of sun protective measures during recess and lunch periods in each school .
METHODS	Researchers will also record the volume of sunscreen that the Year 6 classes in each school utilise over the term .
METHODS	At the conclusion of baseline data collection , five schools will be randomised into an intervention group that will work with researchers to develop a policy-driven intervention to improve sun safety behaviour in NSW primary schools .
CONCLUSIONS	An initial review of relevant Australian and New Zealand literature suggests that provision of policy support is likely to improve school sun protection practices ; however there is no suggested model for this support .
CONCLUSIONS	This will be the first objective analysis of sun safe behaviours leading to a policy-driven intervention conducted in Australian primary schools since the 1990s , and will inform the future direction of sun safety in our schools .
BACKGROUND	Australian and New Zealand Clinical Trials Register ACTRN12614000926639 Registered 28 ( th ) August 2014 .

###24796768
OBJECTIVE	Phosphatidylcholine is a key component of the mucosal barrier .
OBJECTIVE	Treatment with modified release phosphatidylcholine aims to improve the impaired barrier function .
OBJECTIVE	The primary objective is to evaluate the efficacy of LT-02 , a newly designed modified release phosphatidylcholine formula , in a multicenter setting .
METHODS	This is a double-blinded , randomized , placebo-controlled , superiority study conducted in 24 ambulatory referral centers in Germany , Lithuania , and Romania .
METHODS	A total of 156 patients with an inadequate response to mesalazine , a disease activity score ( Simple Clinical Colitis Activity Index ( SCCAI ) ) of 5 , and bloody diarrhea underwent treatment with 0 , 0.8 , 1.6 , or 3.2 g LT-02 .
METHODS	The primary end point was defined a priori as changes in SCCAI from baseline to the end of treatment .
METHODS	The primary statistical model was a general linear least-squares model .
METHODS	The study was funded by the sponsor Lipid Therapeutics , Heidelberg , Germany , and registered at http://clinicaltrials.gov/show/NCT01011322 .
RESULTS	Baseline characteristics and dropouts were well balanced between all groups .
RESULTS	The primary analyses revealed an SCCAI drop of 33.3 % in the placebo group ( from 9.0 to 6.0 points ) compared with 44.3 % in the 0.8 g LT-02 ( from 8.8 to 4.9 , P > 0.05 ) and 40.7 % in the 1.6 g groups ( from 8.6 to 5.1 , P > 0.05 ) .
RESULTS	The 3.2 g group improved 51.7 % from 8.5 to 4.1 ( P = 0.030 in comparison with placebo ) .
RESULTS	The remission rate was 15 % ( 6/40 ) in the placebo group compared with 31.4 % ( 11/35 ) in the highest LT-02 dose group ( P = 0.089 ) .
RESULTS	Mucosal healing was achieved in 32.5 % of placebo patients compared with 47.4 % of LT-02 patients ( P = 0.098 ) ; the rates for histologic remission were 20 % compared with 40.5 % , respectively ( P = 0.016 ) .
RESULTS	There were 17 ( 48.6 % ) treatment-emergent adverse events in the highest dose group ( and 0 serious adverse events ( SAEs ) ) compared with 22 ( 55 % ) in the placebo group ( 4 SAEs ) .
CONCLUSIONS	The primary end point analysis showed a statistically significant improvement in disease activity during LT-02 treatment in comparison with placebo .
CONCLUSIONS	The drug was found to be very safe .

###24372439
OBJECTIVE	To evaluate an individually tailored oral health educational programme on patient-reported outcome compared with a standard oral health educational programme , assess change over time and determine minimal important differences ( MID ) in change scores for two different oral health related quality of life ( OHRQoL ) instrument after non-surgical periodontal treatment ( NSPT ) .
METHODS	In a randomized controlled trial evaluating two educational programmes , patients ( n = 87 ) with chronic periodontitis completed a questionnaire at baseline and after 12 months .
METHODS	OHRQoL was assessed with the General Oral Health Assessment Index ( GOHAI ) and the UK oral health-related quality-of-life measure ( OHQoL-UK ) .
METHODS	In addition , patients ' global rating of oral health and socio-demographic variables were recorded .
METHODS	The MID was estimated with anchor-based and distributions-based methods .
RESULTS	There were no differences between the two educational groups .
RESULTS	The OHRQoL was significantly improved after treatment .
RESULTS	The MID was approximately five for OHQoL-UK with a moderate ES , and three for GOHAI with a Small ES , and 46-50 % of the patients showed improvements beyond the MID .
CONCLUSIONS	Both oral health educational groups reported higher scores in OHRQoL after NSPT resulting in more positive well-being ( OHQoL-UK ) and less frequent oral problems ( GOHAI ) .
CONCLUSIONS	OHQoL-UK gave a greater effect size and mean change scores but both instruments were associated with the participants ' self-rated change in oral health .
CONCLUSIONS	The changes were meaningful for the patients supported by the estimated MID .

###24378865
BACKGROUND	Streamlining the triage process is the key in improving emergency department ( ED ) workflow .
BACKGROUND	Our objective was to determine if parents of pediatric ED patients in , low-literacy , inner-city hospital , who used the audio-assisted bilingual ( English/Spanish ) self-triage kiosk , were able to enter their child 's medical history data using a touch screen panel with greater speed and accuracy than routine nurse-initiated triage .
METHODS	Parent/child dyads visiting the pediatric ED for nonurgent conditions ( February to April 2012 ) were randomized prospectively to self-triage kiosk group ( n = 200 ) and standard nurse triage group ( n = 200 ) .
METHODS	Both groups underwent routine nurse-initiated triage that included verbal elicitation of basic medical history and manual entry into patients ' electronic medical records .
RESULTS	The kiosk user was a parent in 88.5 % of the cases , a patient ( range , 11-17 years ) in 9.5 % of the cases , and a proxy user ( sibling or friend ) in 2 % of the cases .
RESULTS	Language choice for kiosk use was equally distributed ( English vs Spanish , 50.5 % vs 49.5 % ) .
RESULTS	The mean ( SD ) time to enter medical history data by the kiosk group was significantly shorter than the standard nurse triage group ( 94.38 [ 38.61 ] vs 126.72 [ 62.61 ] seconds ; P < 0.001 ) .
RESULTS	Significant inverse relationship was observed between parent education level and kiosk usage time ( r = -0.26 ; P < 0.001 ) .
RESULTS	The mean inaccuracies were significantly lower for kiosk group ( P < 0.05 ) in areas of medical , medication and immunization histories , and total discrepancy score .
CONCLUSIONS	Kiosk triage enabled users to enter basic medical triage history data quickly and accurately in an ED setting with future potential for its wider use in improving ED workflow efficiency .

###24851679
OBJECTIVE	To observe the long-term effects of hydroxychloroquine treatment on blood lipids and left ventricular function of systemic lupus erythematosus ( SLE ) patients .
METHODS	A total of 72 SLE patients were randomly divided into 2 groups of hydroxychloroquine treatment ( n = 36 ) and non-hydroxychloroquine ( n = 36 ) .
METHODS	The serum level of lipids , left ventricular end-diastolic diameter ( LVEDD ) , left ventricular end-systolic diameter ( LVESD ) , interventricular septum thickness ( IVST ) , left ventricular posterior wall thickness ( LVPWT ) , fractional shortening rate ( FS ) , left ventricular ejection fraction ( LVEF ) and E/A ratio were measured before , 6 month , 12 month and 2 years after treatment .
RESULTS	After long-term use of hydroxychloroquine , there were statistically differences in the levels of total cholesterol ( TC ) , triglyceride ( TG ) , low-density lipoprotein ( LDL ) and high-density lipoprotein ( HDL ) .
RESULTS	And LVEDD , LVWPT and E/A were statistically different ( P < 0.05 ) before and after hydroxychloroquine dosing .
CONCLUSIONS	The long-term use of hydroxychloroquine may improve lipid metabolism and left ventricular function in SLE patients .

###25467772
BACKGROUND	The incidence of chronic diseases , including diabetes mellitus ( DM ) , heart failure ( HF ) and chronic obstructive pulmonary disease ( COPD ) is on the rise .
BACKGROUND	The existing health care system must evolve to meet the growing needs of patients with these chronic diseases and reduce the strain on both acute care and hospital-based health care resources .
BACKGROUND	Paramedics are an allied health care resource consisting of highly-trained practitioners who are comfortable working independently and in collaboration with other resources in the out-of-hospital setting .
BACKGROUND	Expanding the paramedic 's scope of practice to include community-based care may decrease the utilization of acute care and hospital-based health care resources by patients with chronic disease .
METHODS	This will be a pragmatic , randomized controlled trial comparing a community paramedic intervention to standard of care for patients with one of three chronic diseases .
METHODS	The objective of the trial is to determine whether community paramedics conducting regular home visits , including health assessments and evidence-based treatments , in partnership with primary care physicians and other community based resources , will decrease the rate of hospitalization and emergency department use for patients with DM , HF and COPD .
METHODS	The primary outcome measure will be the rate of hospitalization at one year .
METHODS	Secondary outcomes will include measures of health system utilization , overall health status , and cost-effectiveness of the intervention over the same time period .
METHODS	Outcome measures will be assessed using both Poisson regression and negative binomial regression analyses to assess the primary outcome .
CONCLUSIONS	The results of this study will be used to inform decisions around the implementation of community paramedic programs .
CONCLUSIONS	If successful in preventing hospitalizations , it has the ability to be scaled up to other regions , both nationally and internationally .
CONCLUSIONS	The methods described in this paper will serve as a basis for future work related to this study .
BACKGROUND	ClinicalTrials.gov : NCT02034045 .
BACKGROUND	Date : 9 January 2014 .

###25309754
OBJECTIVE	To evaluate the relationship of physical activity ( PA ) and sedentary behaviour with gestational weight gain ( GWG ) and birth weight .
METHODS	Combined data from two prospective studies : ( 1 ) nulliparous pregnant women without BMI restrictions and ( 2 ) overweight and obese pregnant women at risk for gestational diabetes .
METHODS	Daily PA and sedentary behaviour were measured with an accelerometer around 15 and at 32-35 weeks of gestation .
METHODS	The association between time spent in moderate-to-vigorous PA ( MVPA ) and in sedentary activities with GWG and birth weight was determined .
METHODS	Main outcome measures were GWG between 15 and 32 weeks of gestation , average GWG per week , and birth weight .
RESULTS	We studied 111 women .
RESULTS	Early in pregnancy , 32 % of women spent 30 minutes/day in at least moderate PA versus 12 % in late pregnancy .
RESULTS	No significant associations were found between time spent in MVPA or sedentary behaviour with GWG or birth weight .
CONCLUSIONS	We found no relation between MVPA and sedentary behaviour with GWG or birth weight .
CONCLUSIONS	The small percentage of women meeting the recommended levels of PA indicates the need to inform and support pregnant women to maintain regular PA , as there seems to be no adverse effect on birth weight and maintaining PA increases overall health .

###24508983
OBJECTIVE	To study whether demographic and smoking-related characteristics are associated with participation ( reach ) in a smoking cessation trial and subsequent use ( uptake ) of two specific smoking interventions ( Internet-based program and proactive telephone counseling ) .
METHODS	We used data from a four-arm randomized smoking cessation trial ( 2011 ) .
METHODS	Participants ( n = 1,809 ) were recruited among 9,924 smokers who previously participated in two health surveys in Denmark ( 2007-2008 and 2010 ) .
METHODS	Interventions were as follows : ( 1 ) an Internet-based smoking cessation program , ( 2 ) proactive telephone counseling , ( 3 ) reactive telephone counseling and ( 4 ) a self-help booklet .
RESULTS	Reach ( defined as the proportion accepting to participate in the trial of those invited ) was highest among persons aged 40-59 years , women , heavy smokers and persons with long education .
RESULTS	Among trial participants , uptake ( defined as any use of the specific intervention at 1-month follow-up ) was 69 % for the Internet-based program , 74 % and 9 % for proactive and reactive telephone counseling , respectively , and 84 % for the self-help booklet .
RESULTS	Young age was associated with the uptake of the Internet-based program , and short education was associated with using proactive telephone counseling .
CONCLUSIONS	Internet-based interventions and proactive telephone counseling appeal to different age and educational groups .
CONCLUSIONS	Further , offering similar intervention content by a proactive and a reactive approach can be associated with different intervention uptake .

###24565342
OBJECTIVE	Supraglottic airway devices are increasingly used as an option to tracheal intubation for elective procedures of varying complexity .
OBJECTIVE	The aim of this study was to prospectively evaluate the clinical use of the laryngeal mask airway Supreme ( ) ( LMAS ) in patients undergoing elective breast surgery and compare it with endotracheal tube ( ETT ) .
METHODS	Sixty patients undergoing breast procedures under general anesthesia were randomly divided into two groups according to the device used ( LMAS or ETT ) .
METHODS	Time of insertion , number of insertion attempts , hemodynamic response to insertion , presence of blood on the device used ; and incidence of sore throat , dysphagia , nausea and vomiting were assessed postoperatively .
RESULTS	There was no difference between groups regarding time of insertion , number of attempts for successful insertion , and presence of blood on the device .
RESULTS	Heart rate and blood pressure after insertion were higher in ETT group .
RESULTS	Incidence of sore throat and dysphagia was also higher in ETT group after two hours in the postoperative period .
RESULTS	There was no difference regarding incidence and severity of complications evaluated after six hours postoperatively .
CONCLUSIONS	The use of the LMAS technique to access airway during general anesthesia for elective breast surgery is as safe and effective as tracheal intubation , with the advantage of promoting smaller hemodynamic response during its management and lower incidence of sore throat and dysphagia in the first hours after surgery .

###25365753
BACKGROUND	In light of the increasing rate of dengue infections throughout the world despite vector-control measures , several dengue vaccine candidates are in development .
METHODS	In a phase 3 efficacy trial of a tetravalent dengue vaccine in five Latin American countries where dengue is endemic , we randomly assigned healthy children between the ages of 9 and 16 years in a 2:1 ratio to receive three injections of recombinant , live , attenuated , tetravalent dengue vaccine ( CYD-TDV ) or placebo at months 0 , 6 , and 12 under blinded conditions .
METHODS	The children were then followed for 25 months .
METHODS	The primary outcome was vaccine efficacy against symptomatic , virologically confirmed dengue ( VCD ) , regardless of disease severity or serotype , occurring more than 28 days after the third injection .
RESULTS	A total of 20,869 healthy children received either vaccine or placebo .
RESULTS	At baseline , 79.4 % of an immunogenicity subgroup of 1944 children had seropositive status for one or more dengue serotypes .
RESULTS	In the per-protocol population , there were 176 VCD cases ( with 11,793 person-years at risk ) in the vaccine group and 221 VCD cases ( with 5809 person-years at risk ) in the control group , for a vaccine efficacy of 60.8 % ( 95 % confidence interval [ CI ] , 52.0 to 68.0 ) .
RESULTS	In the intention-to-treat population ( those who received at least one injection ) , vaccine efficacy was 64.7 % ( 95 % CI , 58.7 to 69.8 ) .
RESULTS	Serotype-specific vaccine efficacy was 50.3 % for serotype 1 , 42.3 % for serotype 2 , 74.0 % for serotype 3 , and 77.7 % for serotype 4 .
RESULTS	Among the severe VCD cases , 1 of 12 was in the vaccine group , for an intention-to-treat vaccine efficacy of 95.5 % .
RESULTS	Vaccine efficacy against hospitalization for dengue was 80.3 % .
RESULTS	The safety profile for the CYD-TDV vaccine was similar to that for placebo , with no marked difference in rates of adverse events .
CONCLUSIONS	The CYD-TDV dengue vaccine was efficacious against VCD and severe VCD and led to fewer hospitalizations for VCD in five Latin American countries where dengue is endemic .
CONCLUSIONS	( Funded by Sanofi Pasteur ; ClinicalTrials.gov number , NCT01374516 . )

###24931823
OBJECTIVE	This study aims to evaluate the feasibility of intraoperative composite target-controlled infusion ( TCI ) anesthesia application using remifentanil hydrochloride with etomidate in patients with severe burns , as monitored by Narcotrend .
METHODS	A total of 40 patients with severe burns with eschar excisions and skin grafts were randomly and equally grouped into the etomidate ( E ) and the propofol groups ( P ) .
METHODS	Anesthesia was induced and maintained by a remifentanil hydrochloride TCI combined with etomidate or propofol .
METHODS	The depth of anesthesia and other relevant indicators were recorded through intraoperative electroencephalogram monitoring using a Narcotrend monitor .
RESULTS	No statistically significant differences were observed between the drug withdrawal times , eye opening requirements , or orientation recoveries of the two groups ( P > 0.05 ) .
RESULTS	The cortisol and aldosterone levels in group E were significantly lower than those in group P 24h post operation ( P < 0.05 ) .
RESULTS	No significant differences between the number of operations , hospitalization duration , mean arterial pressure , heart rate , and postoperative adverse reaction incidence of the two groups were observed at each time point ( P > 0.05 ) .
CONCLUSIONS	The application of a composite remifentanil hydrochloride combined with etomidate TCI is feasible for the early eschar excision in patients with severe burns .

###25313094
BACKGROUND	Uric acid ( UA ) could act as a natural peroxynitrite scavenger with antioxidant properties .
BACKGROUND	It has been proposed that hyperuricemia might protect against multiple sclerosis ( MS ) .
METHODS	Patients with relapsing-remitting MS starting treatment with interferon beta-1a 44 g sc 3/week were randomly assigned to receive either inosine 3 g/day or placebo in a double-blind manner .
METHODS	Follow-up was 12 months .
METHODS	Outcome measures were adverse events and UA laboratory results .
METHODS	Secondary end point was clinical and radiological activity of MS. Relapse rates , percentage of patients without relapses , and progression to secondary MS ( SPMS ) were assessed .
RESULTS	Thirty six patients were included .
RESULTS	Two patients in the inosine group showed UA serum level above 10 mg/ml , and symptoms derived from renal colic not leading to hospital admission .
RESULTS	Ten additional patients had asymptomatic hyperuricemia ( > 7 mg ) .
RESULTS	Efficacy parameters ( clinical and radiological ) were similar between groups .
RESULTS	No patient progressed to SPMS CONCLUSIONS : Inosine administration was associated with hyperuricemia and renal colic with no additional effect on MS. We can not conclude inosine is a safe and well-tolerated drug .
RESULTS	Doses of around 2 g/day may be more appropriate for future trials .

###24750029
OBJECTIVE	This study aimed to compare the efficacy of a peel-off facial mask based on polyvinyl alcohol ( PVA ) with an oil-in-water ( o/w ) emulsion and the effect of a soybean extract fermented by Bifidobacterium animale incorporated in those formulations ( 5 % w/w ) .
METHODS	The formulations were submitted to randomized clinical studies in volunteers to evaluate the measurement effects as ( a ) tensor by Cutometer , ( b ) moisturizing by Corneometer and transepidermal water loss ( TEWL ) by Tewameter .
METHODS	These effects were determined in a short-term study ( 3 h ) in a controlled-temperature room .
RESULTS	The tensor effect and TEWL values indicated no significant difference between the use of facial mask and emulsion .
RESULTS	On the other hand , the moisturizing effect of the facial mask on the stratum corneum was more significant than that of the emulsion according to Corneometer measurements .
RESULTS	Biometric cutaneous evaluation of peel-off facial masks ( short-term study ) showed that the masks promoted moisturizing effect of the stratum corneum more effectively than the oil-in-water emulsions .
RESULTS	Thus , the facial masks were more efficient than emulsions in relation to moisturizing effects , but this efficiency is not related to the presence of fermented soybean extract .
CONCLUSIONS	The results indicated that peel-off facial masks increase skin hydration in a process related to the occlusive effect .

###24239799
BACKGROUND	The possibility and likelihood of a postoperative medical complication after spine surgery undoubtedly play a major role in the decision making of the surgeon and patient alike .
BACKGROUND	Although prior study has determined relative risk and odds ratio values to quantify risk factors , these values may be difficult to translate to the patient during counseling of surgical options .
BACKGROUND	Ideally , a model that predicts absolute risk of medical complication , rather than relative risk or odds ratio values , would greatly enhance the discussion of safety of spine surgery .
BACKGROUND	To date , there is no risk stratification model that specifically predicts the risk of medical complication .
OBJECTIVE	The purpose of this study was to create and validate a predictive model for the risk of medical complication during and after spine surgery .
METHODS	Statistical analysis using a prospective surgical spine registry that recorded extensive demographic , surgical , and complication data .
METHODS	Outcomes examined are medical complications that were specifically defined a priori .
METHODS	This analysis is a continuation of statistical analysis of our previously published report .
METHODS	Using a prospectively collected surgical registry of more than 1,476 patients with extensive demographic , comorbidity , surgical , and complication detail recorded for 2 years after surgery , we previously identified several risk factor for medical complications .
METHODS	Using the beta coefficients from those log binomial regression analyses , we created a model to predict the occurrence of medical complication after spine surgery .
METHODS	We split our data into two subsets for internal and cross-validation of our model .
METHODS	We created two predictive models : one predicting the occurrence of any medical complication and the other predicting the occurrence of a major medical complication .
RESULTS	The final predictive model for any medical complications had a receiver operator curve characteristic of 0.76 , considered to be a fair measure .
RESULTS	The final predictive model for any major medical complications had receiver operator curve characteristic of 0.81 , considered to be a good measure .
RESULTS	The final model has been uploaded for use on SpineSage.com .
CONCLUSIONS	We present a validated model for predicting medical complications after spine surgery .
CONCLUSIONS	The value in this model is that it gives the user an absolute percent likelihood of complication after spine surgery based on the patient 's comorbidity profile and invasiveness of surgery .
CONCLUSIONS	Patients are far more likely to understand an absolute percentage , rather than relative risk and confidence interval values .
CONCLUSIONS	A model such as this is of paramount importance in counseling patients and enhancing the safety of spine surgery .
CONCLUSIONS	In addition , a tool such as this can be of great use particularly as health care trends toward pay-for-performance , quality metrics , and risk adjustment .
CONCLUSIONS	To facilitate the use of this model , we have created a website ( SpineSage.com ) where users can enter in patient data to determine likelihood of medical complications after spine surgery .

###24607801
OBJECTIVE	To determine whether a single trial of interferential current therapy ( ICT ) can immediately alleviate spasticity and improve balance and gait performance in patients with chronic stroke .
METHODS	Randomized , placebo-controlled clinical trial .
METHODS	Inpatient rehabilitation in a local center .
METHODS	A total of 42 adult patients with chronic stroke with plantar flexor spasticity of the lower limb .
METHODS	The ICT group received a single 60-minute ICT stimulation of the gastrocnemius in conjunction with air-pump massage .
METHODS	In the placebo-ICT group , electrodes were placed and air-pump massage performed without electrical stimulation .
METHODS	After a single ICT application , spasticity was measured immediately using the Modified Ashworth Scale ( MAS ) , and balance and functional gait performance were assessed using the following clinical tools : Functional Reach Test ( FRT ) , Berg Balance Scale ( BBS ) , Timed Up and Go Test ( TUG ) , and 10-m Walk Test ( 10MWT ) .
RESULTS	Gastrocnemius spasticity significantly decreased in the ICT group than in the placebo-ICT group ( MAS : ICT vs placebo-ICT : 1.550.76 vs 0.400.50 ) .
RESULTS	The ICT group showed significantly greater improvement in balance and gait abilities than the placebo-ICT group ( FRT : 2.621.21 vs 0.611.34 , BBS : 1.751.52 vs 0.400.88 , TUG : 6.076.11 vs 1.682.39 , 10MWT : 7.027.02 vs 1.963.13 ) .
RESULTS	Spasticity correlated significantly with balance and gait abilities ( P < 0.05 ) .
CONCLUSIONS	A single trial of ICT is a useful intervention for immediately improving spasticity , balance , and gait abilities in chronic stroke patients , but not for long-term effects .
CONCLUSIONS	Further study on the effects of repeated ICT is needed .

###24595146
OBJECTIVE	Pretreatment with intravenous 40 mg or 0.5 mg/kg lidocaine with venous occlusion is recommended to prevent pain following injection of lipid emulsion propofol .
OBJECTIVE	This approach is not sufficient to prevent pain from the injection of microemulsion propofol .
OBJECTIVE	The present study investigated whether a higher dose of lidocaine pretreatment with venous occlusion would be more effective for reducing pain following injection of microemulsion propofol compared with 40 mg lidocaine .
METHODS	Patients undergoing elective surgery were randomly assigned to one of three groups : pretreatment with 40 mg ( group L40 ) , 60 mg ( group L60 ) or 80 mg ( group L80 ) lidocaine intravenously with venous occlusion , followed by injection with microemulsion propofol 1 min later .
METHODS	Pain was assessed on a four-point scale ( severe , moderate , mild , none ) based on physical responses to the injection .
RESULTS	A total of 68 patients were included in the final analysis .
RESULTS	Pain severity and incidence were significantly lower in patients in group L60 and L80 compared with patients in group L40 .
RESULTS	There were no statistically significant differences in pain incidence or severity between group L60 and group L80 .
CONCLUSIONS	Pretreatment with 60 mg lidocaine intravenously with venous occlusion may be the most effective minimum dose for reducing injection pain following microemulsion propofol administration for induction of anaesthesia .

###24664615
BACKGROUND	Depressive symptoms are common among adults with diabetes .
BACKGROUND	Depression and social support may influence diabetes self-management .
OBJECTIVE	This study aimed to examine change in depressive symptoms and the role of depression and support on clinical and dietary outcomes among Latinos with type 2 diabetes participating in a diabetes self-management intervention .
METHODS	Participants ( N = 252 ) were randomized to the intervention or usual care .
METHODS	Mixed effects models were used to examine interaction effects between intervention status and depressive symptoms ( Centers for Epidemiologic Studies Depression ( CES-D ) score ) and support for diabetes self-management behaviors at baseline .
METHODS	Outcomes were measured at baseline and 4 and 12months and included dietary quality , physical activity , depressive symptoms , and hemoglobin A1c levels .
RESULTS	Intervention participants had lower CES-D scores at follow-up than control participants .
RESULTS	An interaction effect between intervention status and CES-D scores predicted diet quality .
CONCLUSIONS	Latinos with depressive symptoms may derive the greatest benefits from diabetes self-management interventions .
CONCLUSIONS	Additional research on support during diabetes self-management interventions is warranted .

###24711067
OBJECTIVE	To assess the long-term ( up to 6 months ) safety profile of a 3-month regimen of NeuroAiD for acute ischemic stroke .
METHODS	A total of 190 patients with acute ischemic stroke were identified for eligibility in a randomized , double-blind , placebo-controlled clinical trial , of which 150 patients allocated to either receiving NeuroAiD ( 80 cases ) or placebo ( 70 cases ) were analyzed after dropouts due to absence of baseline data , early death , or noncompliance .
METHODS	Both groups received treatment for three months and followed up for another three months after the completion of the treatment .
METHODS	Occurrence of clinical adverse events and laboratory parameters were assessed at 1 month , 3 months ( while under treatment ) and 6 months ( 3 months after the completion of treatment ) .
METHODS	Statistical comparisons between groups were performed using chi-square test or t-test whenever appropriate .
RESULTS	The two groups had comparable baseline characteristics .
RESULTS	Mild nausea was more commonly reported in patients taking NeuroAid compared with placebo ( P = 0.01 ) , of which 9 out of 10 were observed only during the first month of treatment .
RESULTS	However , none of the adverse events reported were considered severe or required discontinuation of the study drug .
RESULTS	There was no significant change observed in mean arterial blood pressure , haemoglobin , renal and liver laboratory parameters during treatment with NeuroAid and up to 3 months after completion of a 3-month regimen .
CONCLUSIONS	NeuroAiD is safe and does not affect hematologic , hepatic , and renal functions during and long after completion of treatment .

###24465955
BACKGROUND	The pre-drinking mood state has been indicated to be an important factor in the mood effects of alcohol .
BACKGROUND	However , for moderate alcohol consumption there are no controlled studies showing this association .
BACKGROUND	Also , the mood effects of consuming alcohol combined with food are largely unknown .
BACKGROUND	The aim of this study was to investigate the effects of moderate alcohol combined with a meal on ambiance-induced mood states .
BACKGROUND	Furthermore effects on autonomic nervous system activity were measured to explore physiological mechanisms that may be involved in changes of mood state .
METHODS	In a crossover design 28 women ( age 18-45 y , BMI 18.5-27 kg/m2 ) were randomly allocated to 4 conditions in which they received 3 glasses of sparkling white wine ( 30 g alcohol ) or alcohol-free sparkling white wine while having dinner in a room with either a pleasant or unpleasant created ambiance .
METHODS	Subjects filled out questionnaires ( B-BAES , POMS and postprandial wellness questionnaire ) at different times .
METHODS	Skin conductance and heart rate variability were measured continuously .
RESULTS	Moderate alcohol consumption increased happiness scores in the unpleasant , but not in the pleasant ambiance .
RESULTS	Alcohol consumption increased happiness and stimulation feelings within 1 hour and increased sedative feelings and sleepiness for 2.5 hour .
RESULTS	Skin conductance was increased after alcohol within 1 hour and was related to happiness and stimulation scores .
RESULTS	Heart rate variability was decreased after alcohol for 2 hours and was related to mental alertness .
CONCLUSIONS	Mood inductions and autonomic nervous system parameters may be useful to evaluate mood changes by nutritional interventions .
CONCLUSIONS	Moderate alcohol consumption elevates happiness scores in an unpleasant ambiance .
CONCLUSIONS	However , drinking alcohol during a pleasant mood results in an equally positive mood state .
BACKGROUND	Clinicaltrials.gov NCT01426022 .

###25746509
OBJECTIVE	Remotely monitored patients may be at risk for a delayed response to critical arrhythmias if the telemetry watchers who monitor them are subject to an excessive patient load .
OBJECTIVE	There are no guidelines or studies regarding the appropriate number of patients that a single watcher may safely and effectively monitor .
OBJECTIVE	Our objective was to determine the impact of increasing the number of patients monitored on response time to simulated cardiac arrest .
METHODS	Randomized trial .
METHODS	Laboratory-based experiment .
METHODS	Forty-two remote telemetry technicians and nurses from cardiac units .
METHODS	Number of patients monitored in a simulation of cardiac telemetry monitoring work .
RESULTS	We carried out a study to compare response times to ventricular fibrillation across five patient loads : 16 , 24 , 32 , 40 , and 48 patients .
RESULTS	The simulation replicated the work of telemetry watchers using a combination of real recorded patient electrocardiogram signals and a simulated patient experiencing ventricular fibrillation .
RESULTS	Study participants were assigned to one of the five patient loads and completed a 4-hour monitoring session , during which they performed tasks-including event documentation and phone calls to report events-similar to real monitoring work .
RESULTS	When the simulated patient sustained ventricular fibrillation , the time required to report this arrhythmia was recorded .
RESULTS	As patient loads increased , there was a statistically significant increase in response times to the ventricular fibrillation .
RESULTS	In addition , frequency of failure to meet a response time goal of less than 20 seconds was significantly higher in the 48-patient condition than in all other conditions .
RESULTS	Task performance decreased as patient load increased .
CONCLUSIONS	As participants monitored more patients in a laboratory setting , their performance with respect to recognizing critical and noncritical events declined .
CONCLUSIONS	This study has implications for the design of remote telemetry work and other patient monitoring tasks in critical and intermediate care units .

###25495459
BACKGROUND	We conducted a nested randomised trial to evaluate the effect of an educational DVD , providing information about healthy food choices and exercise during pregnancy , on diet and physical activity , among pregnant women who were overweight or obese .
METHODS	We conducted a nested randomised trial within the context of the LIMIT randomised trial .
METHODS	Women were eligible with a singleton pregnancy between 10 and 20weeks gestation , and body mass index at the time of their first antenatal appointment of 25kg/m ( 2 ) .
METHODS	All women who were randomised to the Lifestyle Advice Group of the LIMIT trial received a series of consultations with both research dieticians and research assistants , in addition to standard written dietary and exercise materials ( Standard Materials Group ) .
METHODS	Women randomised to the DVD Group received the same consultations and written materials , and additionally received an educational DVD ( DVD Group ) .
METHODS	The primary study outcome was the Healthy Eating Index .
METHODS	Other study outcomes included physical activity , and gestational weight gain .
METHODS	Women completed a qualitative evaluation of all the materials provided .
RESULTS	1,108 women in the LIMIT Lifestyle Advice Group participated in the nested trial , with 543 women randomised to the DVD Group , and 565 women to the Standard Materials Group .
RESULTS	Women who received the DVD compared with those who did not , had a higher mean Healthy Eating Index at 36weeks gestation ( 73.6 vs 72.3 ; adjusted mean difference 1.2 ; 95 % CI 0.2 to 2.3 ; p = 0.02 ) , but not at 28weeks gestation ( 73.2 vs 73.5 ; adjusted mean difference -0.1 ; 95 % CI -1.1 to 0.9 ; p = 0.82 ) .
RESULTS	There were no statistically significant differences in physical activity or total gestational weight gain .
RESULTS	While most women evaluated the materials positively , frequency of utilisation was poor .
CONCLUSIONS	Ongoing attention to the delivery of information is required , particularly with the increased use and availability of digital and multi-media interactive technologies .
BACKGROUND	Australian and New Zealand Clinical Trials Registry ACTRN12607000161426 .

###25523533
OBJECTIVE	This study sought to investigate whether the beneficial impact of high-dose rosuvastatin against contrast-induced acute kidney injury ( CI-AKI ) in acute coronary syndrome ( ACS ) patients varied in relation to baseline high-sensitivity C-reactive protein ( hs-CRP ) levels .
BACKGROUND	High-dose rosuvastatin administered on admission has been shown to prevent CI-AKI and improve short - and mid-term clinical outcome in ACS patients .
METHODS	All 504 statin-nave ACS patients enrolled in the PRATO-ACS ( Protective Effect of Rosuvastatin and Antiplatelet Therapy on Contrast-Induced Acute Kidney Injury and Myocardial Damage in ACS Patients ) study were stratified into baseline hs-CRP tertiles : < 2.7 mg/l , 2.7 to < 7.5 mg/l , and 7.5 mg/l .
METHODS	The primary endpoint was CI-AKI occurrence ( creatinine 0.5 mg/dl or 25 % above baseline within 72 h ) .
METHODS	Logistic regression models were used to evaluate the relationship between hs-CRP levels and effects of rosuvastatin .
RESULTS	Patients with higher baseline hs-CRP values presented a significantly higher incidence of CI-AKI ( 5.4 % , 8.7 % , and 18.3 % in the first , second , and third tertiles , respectively ; p = 0.0001 ) .
RESULTS	The beneficial effect of rosuvastatin was markedly significant in the third hs-CRP tertile ( odds ratio : 0.20 ; 95 % confidence interval : 0.07 to 0.54 ; p = 0.002 ) .
RESULTS	Statin-treated patients in the third tertile presented a significantly lower rate of adverse events at 30 days ( 7.2 % vs. 17.4 % , p = 0.043 ) with a trend toward better outcome at 6 months ( 6.02 % vs. 13.04 % , p = 0.12 ) .
CONCLUSIONS	High-dose rosuvastatin administered on admission appears to exert more effective kidney protection in ACS subjects with higher baseline hs-CRP levels resulting in better short - and mid-term clinical outcome .
CONCLUSIONS	( Protective Effect of Rosuvastatin and Antiplatelet Therapy on Contrast-Induced Nephropathy and Myocardial Damage in Patients With Acute Coronary Syndrome Undergoing Coronary Intervention [ PRATO-ACS ] ; NCT01185938 ) .

###26115796
BACKGROUND	Patients with melanoma that progresses on ipilimumab and , if BRAF ( V600 ) mutant-positive , a BRAF or MEK inhibitor or both , have few treatment options .
BACKGROUND	We assessed the efficacy and safety of two pembrolizumab doses versus investigator-choice chemotherapy in patients with ipilimumab-refractory melanoma .
METHODS	We carried out a randomised phase 2 trial of patients aged 18 years or older from 73 hospitals , clinics , and academic medical centres in 12 countries who had confirmed progressive disease within 24 weeks after two or more ipilimumab doses and , if BRAF ( V600 ) mutant-positive , previous treatment with a BRAF or MEK inhibitor or both .
METHODS	Patients had to have resolution of all ipilimumab-related adverse events to grade 0-1 and prednisone 10 mg/day or less for at least 2 weeks , an Eastern Cooperative Oncology Group ( ECOG ) performance status of 0 or 1 , and at least one measurable lesion to be eligible .
METHODS	Using a centralised interactive voice response system , we randomly assigned ( 1:1:1 ) patients in a block size of six to receive intravenous pembrolizumab 2 mg/kg or 10 mg/kg every 3 weeks or investigator-choice chemotherapy ( paclitaxel plus carboplatin , paclitaxel , carboplatin , dacarbazine , or oral temozolomide ) .
METHODS	Randomisation was stratified by ECOG performance status , lactate dehydrogenase concentration , and BRAF ( V600 ) mutation status .
METHODS	Individual treatment assignment between pembrolizumab and chemotherapy was open label , but investigators and patients were masked to assignment of the dose of pembrolizumab .
METHODS	We present the primary endpoint at the prespecified second interim analysis of progression-free survival in the intention-to-treat population .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01704287 .
METHODS	The study is closed to enrolment but continues to follow up and treat patients .
RESULTS	Between Nov 30 , 2012 , and Nov 13 , 2013 , we enrolled 540 patients : 180 patients were randomly assigned to receive pembrolizumab 2 mg/kg , 181 to receive pembrolizumab 10 mg/kg , and 179 to receive chemotherapy .
RESULTS	Based on 410 progression-free survival events , progression-free survival was improved in patients assigned to pembrolizumab 2 mg/kg ( HR 057 , 95 % CI 045-073 ; p < 00001 ) and those assigned to pembrolizumab 10 mg/kg ( 050 , 039-064 ; p < 00001 ) compared with those assigned to chemotherapy .
RESULTS	6-month progression-free survival was 34 % ( 95 % CI 27-41 ) in the pembrolizumab 2 mg/kg group , 38 % ( 31-45 ) in the 10 mg/kg group , and 16 % ( 10-22 ) in the chemotherapy group .
RESULTS	Treatment-related grade 3-4 adverse events occurred in 20 ( 11 % ) patients in the pembrolizumab 2 mg/kg group , 25 ( 14 % ) in the pembrolizumab 10 mg/kg group , and 45 ( 26 % ) in the chemotherapy group .
RESULTS	The most common treatment-related grade 3-4 adverse event in the pembrolizumab groups was fatigue ( two [ 1 % ] of 178 patients in the 2 mg/kg group and one [ < 1 % ] of 179 patients in the 10 mg/kg group , compared with eight [ 5 % ] of 171 in the chemotherapy group ) .
RESULTS	Other treatment-related grade 3-4 adverse events include generalised oedema and myalgia ( each in two [ 1 % ] patients ) in those given pembrolizumab 2 mg/kg ; hypopituitarism , colitis , diarrhoea , decreased appetite , hyponatremia , and pneumonitis ( each in two [ 1 % ] ) in those given pembrolizumab 10 mg/kg ; and anaemia ( nine [ 5 % ] ) , fatigue ( eight [ 5 % ] ) , neutropenia ( six [ 4 % ] ) , and leucopenia ( six [ 4 % ] ) in those assigned to chemotherapy .
CONCLUSIONS	These findings establish pembrolizumab as a new standard of care for the treatment of ipilimumab-refractory melanoma .
BACKGROUND	Merck Sharp & Dohme .

###25997544
OBJECTIVE	Febuxostat is a selective inhibitor of xanthine oxidase , which is used to manage hyperuricemia in patients with gout .
OBJECTIVE	The objective of the study was to compare the pharmacokinetics of two different strength of febuxostat formulations ( 80 mg and 40 mg ) .
METHODS	A randomized , single-dose , open-label , two-period , two-sequence crossover study with a 7-day washout period was conducted in 30 healthy male subjects .
METHODS	Participants received either reference ( 1 80 mg ) or test ( 2 40 mg ) formulations during the first period and the alternative formulation during the second period .
METHODS	Plasma samples for the drug analysis were collected up to 24 hours after treatment .
RESULTS	All pharmacokinetic parameters were comparable between the two formulations The observed mean Cmax , AUC ( last ) , and AUC ( ) values for the reference formulation were 3,670 ng/mL , 12,086 ng x h/mL , and 12,880 ng x h/mL , respectively .
RESULTS	Corresponding values for the test formulation were 4,108 ng/mL , 12,689 ng x h/mL , and 13,278 ng x h/mL , respectively .
RESULTS	The geometric mean ratios ( 90 % CI ) between the two formulations were 1.1273 ( 1.0286 - 1.2355 ) for Cmax , 1.054 ( 1.0115 - 1.0980 ) for AUC ( last ) , and 1.0395 ( 0.9959 - 1.0851 ) for AUC ( ) .
RESULTS	The changes of serum uric acid at 24 hours after reference and test formations were comparable ( -1.36 mg/dL for reference and -1.37 mg/dL for test ; p = 0.892 ) .
CONCLUSIONS	The results of the present study indicated that the reference and test formulations have comparable pharmacokinetics and that these two formulations meet the regulatory criteria for bioequivalence .
CONCLUSIONS	In addition , the reduction of serum UA levels in the reference formulation was similar to that of the test formulation after a single dose .

###25251794
OBJECTIVE	The aim of this study was to determine whether massage therapy can be used as an adjunct intervention to induce sleep in infants born preterm .
METHODS	Thirty infants born at a minimum of 28 weeks gestational age , who were at the time of the study between 32 and 48 weeks adjusted gestational age , were randomly assigned to receive massage therapy on 1 day and not receive massage on an alternate day .
METHODS	The Motionlogger Micro Sleep Watch Actigraph recorded lower extremity activity on the morning of each day .
RESULTS	No significant difference was found between groups for sleep efficiency ( P = .13 ) during the time period evaluated .
RESULTS	Groups differed significantly during the time period after the massage ended with more infants sleeping on the nonmassage day ( = 4.9802 , P = .026 ) .
CONCLUSIONS	Massage is well tolerated in infants born preterm and infants do not fall asleep faster after massage than without massage .

###25641535
BACKGROUND	Circulating levels of cardiac troponin I ( cTnI ) after ST-segment elevation myocardial infarction ( STEMI ) are associated with infarct size and chronic left ventricular dysfunction , but the relation to clinical end points and biochemical measures of global cardiac function remains less well defined .
METHODS	One thousand sixty-six patients receiving primary percutaneous coronary intervention ( PCI ) in the PROTECTION AMI trial were studied in a post hoc analysis .
METHODS	Cardiac troponin I was measured at several time points during the index hospitalization , and patients were followed up for 3 months before reassessment including N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) and left ventricular ejection fraction ( LVEF ) measurements .
RESULTS	The median ( quartile 1-3 ) cTnI levels were 0.4 ( 0.1-0 .4 ) g/L at admission , 33.1 ( 12.8-72 .1 ) g/L after 16 to 24 hours , and 9.1 ( 3.9-17 .5 ) g/L after 70 to 80 hours .
RESULTS	In adjusted models , all post-PCI single points , peak , and area under curve were found to be independently associated with clinical events , NT-proBNP > 118 pmol/L , or LVEF < 40 % ( P for all < .001 ) .
RESULTS	When cTnI was added to a baseline risk model for prediction of clinical events , the C statistic improved from 0.779 to 0.846 ( 16-24 hours ) and 0.859 ( 70-80 hours ) .
RESULTS	Quantified by integrated discrimination improvement , the addition of cTnI significantly augmented prediction ability ( relative integrated discrimination improvement 44 % -154 % ; P for all .001 ) .
RESULTS	Consistent improvements in discrimination of NT-proBNP > 118 pmol/L and LVEF < 40 % were observed .
CONCLUSIONS	Cardiac troponin I measured after primary PCI for STEMI is independently associated with clinical outcomes and cardiac function through 3-month follow-up .
CONCLUSIONS	These results suggest that cTnI levels are a useful risk stratification tool in STEMI patients .

###24685971
OBJECTIVE	Published studies of triptans in acute migraine have shown relatively disappointing 2-hour pain-free rates , ranging from 18 % to 58 % , with 2 - to 24-hour sustained pain-free rates from 17 % to 25 % .
OBJECTIVE	A major flaw in the design of previous studies may have contributed to disappointing results : many subjects are not truly episodic in the nature of their headaches-they discount days with mild headache and ignore days with migraine-related neck pain .
OBJECTIVE	Believing that neck pain is integrally related to migraine , we sought to ascertain whether early treatment with sumatriptan 85/naproxen sodium 500 ( sumatriptan/naproxen ) in truly episodic migraineurs is more robust than results when neck pain has not been considered .
METHODS	Successfully screened adult migraineurs who returned baseline diaries showing 2 to 7 migraine attacks monthly and < 15 headache and/or neck pain days/month received blister packs containing 3 sumatriptan/naproxen/1 placebo for treatment of 4 migraines .
METHODS	Instructions were to treat within the first 30 minutes of mild headache or neck discomfort-but only if the preceding day was completely free of both headache and neck pain .
RESULTS	In our study , 63.9 % of patient attacks treated with sumatriptan/naproxen achieved 2-hour pain freedom compared with 33.3 % of those with placebo ( P < 0.001 ) .
RESULTS	Sustained pain freedom ( 2-24 hours ) was achieved in 69.1 % of sumatriptan/naproxen-treated attacks , compared with 23.3 % with placebo ( P < 0.01 ) .
RESULTS	More subjects using sumatriptan/naproxen achieved sustained pain freedom ( than 2-hour pain freedom ) , due to 6 time points when the subject was sleeping/napping 2-hours post dose ( 5 sumatriptan/naproxen , 1 placebo ) , yet attested to no discomfort between 2 and 24 hours post dose .
RESULTS	Had the attacks been scored as pain-free at 2 hours , the 2-hour pain-free and sustained pain-free rates with sumatriptan/naproxen would have been identical at 69.1 % ( vs 36.7 % with placebo ) .
RESULTS	With truly episodic migraineurs , pain freedom was significant as soon as 15 minutes following treatment with sumatriptan/naproxen ( 5.2 % vs 0 % with placebo ; P < 0.01 ) .
CONCLUSIONS	Our study results support a fundamental re-evaluation of the role of neck pain in migraine .

###25277549
BACKGROUND	Endobronchial valve ( EBV ) therapy is an innovative treatment that has been shown to be safe and effective in selected subgroups of patients with severe emphysema .
OBJECTIVE	The objective of our study was to assess the cost-effectiveness of EBV therapy compared to the medical management of patients with high heterogeneity , complete fissures and lobar exclusion in the context of the German health-care system .
METHODS	Clinical data from a subset of VENT ( Endobronchial Valve for Emphysema Palliation Trial ) provided information about clinical events , health-related quality of life , and disease staging for 12 months .
METHODS	This information was subsequently used to project long-term disease progression , mortality , and health resource utilization .
METHODS	We computed the 5 - and 10-year incremental cost-effectiveness ratio ( ICER ) in euros per quality-adjusted life year ( QALY ) .
METHODS	Costs and effects were discounted at 3 % per year .
RESULTS	EBV therapy led to clinically meaningful disease restaging at 12 months ( 37.8 % of the cohort improved staging , compared to 0 % in the controls ) .
RESULTS	Over 5 years , EBV therapy was projected to increase survival from 66.4 to 70.7 % , and to add 0.22 QALYs .
RESULTS	Costs were estimated to increase by EUR 10,299 , resulting in an ICER of EUR 46,322 per QALY .
RESULTS	Over 10 years , 0.41 QALYs were gained at an additional cost of EUR 10,425 , yielding an ICER of EUR 25,142 per QALY .
CONCLUSIONS	Our model-based analysis suggests that EBV therapy leads to clinically meaningful changes in disease staging and progression when compared to medical management , with resulting gains in unadjusted and quality-adjusted life expectancy .
CONCLUSIONS	Our results indicate that EBV therapy is cost-effective in the German health-care system .

###24767716
OBJECTIVE	Burns remain disproportionately prevalent in developing countries .
OBJECTIVE	This study aims to describe the epidemiology of burns in Sierra Leone to serve as a baseline for future programs .
METHODS	A cluster randomized , cross-sectional , countrywide survey was conducted in 2012 in Sierra Leone .
METHODS	With a standardized questionnaire demographics and deaths during the previous 12 months of household members were assessed with the household representative .
METHODS	Thereafter , 2 randomly selected household members were interviewed , elucidating whether participants had ever had a burn in six body regions and determining burn mechanisms and patterns of health care seeking behavior .
RESULTS	This study included 1843 households and 3645 individuals .
RESULTS	3.98 % ( 145/3645 ) of individuals reported at least one burn-injury .
RESULTS	The highest proportions of burns were reported in the age groups 0-4 years old ( 23/426 , 5.4 % ) and 5-14 years old ( 37/887 , 4.17 % ) .
RESULTS	The majority of burns ( 129/145 , 89.0 % ) were caused by a hot liquid/object and the upper , extremities were the most commonly burned body regions , with 36 % ( 53/145 ) of cases .
RESULTS	21 % ( 30/145 ) of individuals with burns sought care from a traditional healer .
CONCLUSIONS	Burns are highly prevalent in Sierra Leone .
CONCLUSIONS	Further research and resources should be allocated to the care and prevention of thermal injuries .

###24554519
OBJECTIVE	We investigated whether micronutrients given acutely following the Christchurch earthquakes continued to confer benefit 1 year following the treatment .
METHODS	Sixty-four adults from the original 91 participants experiencing heightened anxiety or stress 2-3 months following the 22nd February 2011 earthquake and who had been randomized to receive three different doses of micronutrients completed on-line questionnaires assessing mood , anxiety , stress , and symptoms associated with post-traumatic stress disorder 1 year after completing the initial study .
METHODS	Twenty-one out of 29 nonrandomized controls who did not receive the treatment also completed the questionnaires .
RESULTS	Both the treated and control groups experienced significant improvement in psychological functioning compared with end-of-trial .
RESULTS	However , treated participants had better long-term outcomes on most measures compared with controls ( ES = 0.69-1 .31 ) .
RESULTS	Those who stayed on micronutrients through to follow-up or stopped all treatment reported better psychological functioning than those who switched to other treatments including medications .
RESULTS	About 10 % of the sample continued to have post-traumatic stress disorder symptoms .
CONCLUSIONS	Disaster survivors improve psychologically over time regardless of receiving intervention ; however , those taking micronutrients during the acute phase following a disaster show better outcomes , identifying micronutrients as a viable treatment for acute stress following a natural disaster with maintenance of benefits 1 year later .
CONCLUSIONS	ACTRN 12611000460909

###24628955
OBJECTIVE	To investigate an infusion of propofol for anesthesia in comparison to tiletamine-zolazepam anesthesia , evaluating physiological variables and recovery in squirrel monkeys .
METHODS	Prospective non-blinded randomized study .
METHODS	Eight healthy squirrel monkeys ( Saimiri sciureus ) , aged 3years and weighing 0.340-0 .695 kg .
METHODS	Premedication was intramuscular midazolam ( 0.5 mg ) and meperidine ( 4mg ) .
METHODS	Anesthesia was induced with intravenous ( IV ) propofol ( 4mgkg ( -1 ) minute ( -1 ) ) and maintained with propofol starting at 0.4 mgkg ( -1 ) minute ( -1 ) ( PRO , n = 4 ) or IV tiletamine-zolazepam ( 5mgkg ( -1 ) ) and maintained with supplementary doses of TZ ( TZ , n = 4 ) .
METHODS	Cardiopulmonary variables were measured continuously .
METHODS	Arterial blood gases and lactate concentration were measured at the end of anesthesia .
METHODS	Quality and times of recovery were determined .
METHODS	Repeatedly measured data for significant differences were tested between groups with t-test and within groups by anova .
RESULTS	Median time for induction of anesthesia in PRO was 180seconds .
RESULTS	Mean maintenance infusion rate of propofol was 0.430.05 mgkg ( -1 ) minute ( -1 ) , varying during the 1hour period .
RESULTS	One monkey died after administration of TZ ; others required 1 , 4 , or 8 supplemental doses .
RESULTS	Cardiopulmonary variables were similar between groups , but hypotension was recorded .
RESULTS	Recovery times to ventral recumbency in PRO ( 3217minutes ) and TZ ( 8411minutes ) and normal ambulation in PRO ( 5822minutes ) and TZ ( 358109minutes ) were significantly different ( p < 0.05 ) .
RESULTS	Recovery quality was superior in PRO , with less ataxia and fewer unsuccessful attempts to stand .
RESULTS	Lactate concentration was not different between treatments .
CONCLUSIONS	Cardiopulmonary variables were similar between protocols , aside from the higher incidence of hypotension in PRO , indicating that further studies with a larger number of animals are required .
CONCLUSIONS	Compared to tiletamine-zolazepam , propofol anesthesia provided faster and superior anesthetic recovery in these animals .

###25022824
OBJECTIVE	The objectives of this study were to evaluate the effects of medication education and behavioral intervention on Chinese patients with epilepsy and to compare the difference between them .
METHODS	A total of 109 patients with epilepsy who did not to take their antiepileptic drugs ( AEDs ) more than once were randomly assigned to two intervention groups : the medication education group ( group I ) and the medication education with behavioral intervention group ( group II ) .
METHODS	Group I was initially provided with medication education in the form of oral education and written materials , and this education was reinforced by monthly calls from the pharmacist over the next six months .
METHODS	The behavioral intervention provided to group II consisted of a modified medication schedule which was based on cue-dose training therapy .
METHODS	The outcomes that were evaluated both in the beginning and in the end of the study included adherence , which was measured using the four-item Morisky Medication Adherence Scale ( MMAS-4 ) , the number of seizures , knowledge of AEDs , and the number of patients who missed a dose of their AEDs .
METHODS	Differences within and between the groups were analyzed .
RESULTS	After intervention , the adherence and knowledge of AEDs increased greatly in all patients , and the number of patients who had seizures or missed AEDs decreased .
RESULTS	However , no significant differences were observed between groups I and II .
RESULTS	The observed changes were ( group I vs group II , p value ) increased adherence : 62.3 % vs 64.3 % , 0.827 ; increased knowledge of AEDs : 88.7 % vs 80.4 % , 0.231 ; and improved seizure control : 64.2 % vs 64.3 % , 0.988 .
RESULTS	In addition , the percentage of patients who forgot to take their AEDs decreased to 45.0 % from more than 70 % , and 44.9 % of these patients took the missed AEDs as soon as they remembered .
CONCLUSIONS	These findings clearly demonstrate that medication education and reinforced telephone calls from pharmacists can help to increase adherence to AEDs , the knowledge of patients regarding AEDs , and seizure control .
CONCLUSIONS	However , the inclusion of a behavioral strategy that was easy to administer and use in this program did not lead to any significant effects on improving adherence .
CONCLUSIONS	The results indicate that pharmacists can play an important role in improving the effects of medication regimens , but further research is required to identify strategies for improving adherence to behavioral theory .

###25817108
OBJECTIVE	To compare between the effects of cold and warm ischemia on the risk of deterioration of renal insufficiency in patients with T1 renal tumor managed by partial nephrectomy .
METHODS	This prospective randomized study was performed on 120 patients with chronic kidney disease , all having T1 renal tumors .
METHODS	Renal function was estimated by estimated glomerular filtration rate ( eGFR ) , using the Modification of Diet in Renal Disease formula .
METHODS	Patients were randomly divided into 2 groups : in group A , warm ischemia was used , and in group B , cold ischemia was used .
METHODS	All patients were treated by open partial nephrectomy .
METHODS	Patients were followed up for 2years .
METHODS	The primary outcome of the study was eGFR at 2years .
METHODS	Secondary outcomes were tumor recurrence , loss of follow-up , or patient death .
RESULTS	Mean age of patients was 60.7 5.3 years .
RESULTS	Associated chronic disease ( diabetes and/or hypertension ) was present in 93 patients .
RESULTS	Worsening of renal insufficiency occurred within 1month of surgery in 38 patients ( 27 in group A and 11 in group B ) .
RESULTS	At 3months follow-up , 21 of these 38 patients returned to their baseline eGFR .
RESULTS	Warm ischemia rendered patients more prone to a decrease in eGFR after partial nephrectomy , with relative risk of 1.34 and 2 times at 3months and 2years of follow-up , respectively .
CONCLUSIONS	Warm ischemia increases the risk of deterioration of renal functions in patients with renal insufficiency undergoing open partial nephrectomy for renal tumors .

###26027619
BACKGROUND	Impaired nitric oxide-mediated pulmonary vascular tone is commonly found in heart failure with reduced ejection fraction ( HFrEF ) , and is associated with derangement of left ventricular ( LV ) hemodynamics and decreased exercise capacity , which may be reversed by PDE5 inhibitor .
BACKGROUND	This study investigated the effects of a new , long-acting PDE5 inhibitor on LV hemodynamics and exercise capacity in HFrEF .
METHODS	Patients with chronic HFrEF on optimal medical therapy for > 30 days before enrollment were randomly assigned to placebo or udenafil at a dose of 50mg 2x/day for the first 4 weeks followed by 100mg 2x/day for the next 8 weeks .
METHODS	All patients underwent cardiopulmonary exercise echocardiography before and after the 12-week treatment .
RESULTS	Improvement of subjective functional capacity was more frequently reported in the udenafil group ( P = 0.002 ) .
RESULTS	Also , a higher increase in peak VO2 ( peak VO2 , 21.6 % ( 6.9 ~ 106.4 % ) vs 1.9 % ( -15.7 ~ 21.0 % ) in the placebo group , P = 0.04 ) and a larger decrease in ventilatory efficiency were observed in the udenafil group ( -6.4 9.7 vs 1.9 12.1 in the placebo group , P = 0.03 ) .
RESULTS	Regarding LV systolic function , the extent of increment in LV ejection fraction was significantly greater in the udenafil group ( 6.6 6.4 % vs 2.3 4.8 % in the placebo group , P = 0.02 ) .
RESULTS	In the udenafil group , an echocardiographic surrogate of LV filling pressure was more prominently decreased ( P = 0.006 ) along with a significant reverse remodeling of left atrial volume index ( 57 25mL at baseline to 44 23 at 12th week , P = 0.04 ) and a progressive fall in B-type natriuretic peptide level ( 589 679pg/mL at baseline to 220 225pg/mL at 12th week , P < 0.001 ) , indicating LV diastolic function improvement .
RESULTS	Udenafil was well tolerated without excess of adverse events compared to placebo .
CONCLUSIONS	Udenafil improves LV systolic/diastolic functions and exercise capacity in conjunction with established conventional pharmacotherapy , without significant adverse events in HFrEF .

###24755129
OBJECTIVE	Two studies assessing ticagrelor pharmacokinetics , pharmacodynamics , and tolerability in healthy Japanese and Caucasian volunteers .
METHODS	Single-ascending dose ( SAD ) study : Japanese ( n = 20 ) and Caucasians ( n = 20 ) received single doses of ticagrelor ( 50 , 100 , 200 , 300 , 400 , and 600 mg ) or placebo .
METHODS	Multiple-ascending dose ( MAD ) study : Japanese ( n = 36 ) and Caucasians ( n = 36 ) received single doses of 100 mg or 300 mg ticagrelor ( day 1 ) , twice-daily 100 mg or 300 mg ticagrelor , or placebo ( days 4 9 ) , and single doses of 100 mg or 300 mg ticagrelor ( day 10 ) .
RESULTS	Exposure to ticagrelor and its active metabolite , AR-C124910XX , was generally higher in Japanese vs. Caucasians .
RESULTS	In the SAD study , area under the plasma concentration-time curve ( AUC ) values were 33 % ( ticagrelor ) and 55 % ( AR-C124910XX ) greater in Japanese vs. Caucasians following 600 mg ticagrelor .
RESULTS	In the MAD study , AUC values of ticagrelor and AR-C124910XX following multiple doses of ticagrelor 100 mg and 300 mg were statistically significantly greater ( 33 - 48 % ) in Japanese vs. Caucasians .
RESULTS	In both groups , mean peak inhibition of platelet aggregation was > 86 % after single doses ( > = 100 mg ticagrelor ) and > 84 % after multiple doses .
RESULTS	Bleeding times were > = 60 minutes in more Japanese than Caucasians with multiple dosing of 100 mg and 300 mg ticagrelor Adverse events were similar between groups ( mild-to-moderate intensity ) .
CONCLUSIONS	The pharmacokinetics and tolerability of ticagrelor were broadly similar in Japanese and Caucasians , although exposure was slightly greater in Japanese volunteers .
CONCLUSIONS	Ticagrelor was generally well tolerated .

###24972473
BACKGROUND	The use of procinticos in the critical patient with nutrition enteral , they have as aim reduce the increase of the gastric residue ( RG ) .
BACKGROUND	We evaluate his efficiency in the improvement of the intake enteral and on the reduction in the incident gastrointestinal complications ( CGI ) and pneumonia , in critical patients , with neurological injury Aims : To evaluate the effects in the administration metoclopramide ( MCG ) , during the first five days with enteral nutrition , versus control ( GC ) , on the volume of administered diet , gastrointestinal complications and the incidence of mechanical ventilation associated pneumonia ( NAVM ) , in neuro-critically patients ( NC ) of traumatic and vascular aetiology .
BACKGROUND	Prospective , closed-label , randomized study performed in an intensive Care Unit .
BACKGROUND	Methords : 150 adult neuro-critical patients ( NC ) were admitted of consecutive form and 109 were randomly and two groups 58 MCG y 51 GC .
BACKGROUND	The primary outcomes was the nutritional : the volume of administered diet ( VAD ) ; mean efficacious volume ( MEV ) measured in three consecutive periods of time ; the gastrointestinal complications ( GIC ) , and the rate of partial and definitive suspension of the diet .
BACKGROUND	Infecction : incidence of ventilator associated pneumonia NAVM ; and of secondary outcomes were : the duration of mechanical ventilation , length of ICU and hospital stay , and incidence the serious sequelae , and 30 days mortality .
RESULTS	Differences were not observed in the severity variables between groups on admission .
RESULTS	A significant increase was observed in the global values and in the first five days of ( p < 0.03 ) of the VEM in the group of MCG .
RESULTS	The values of the global VDA and during three phases of study , the number CGI , the rate of partial and definitive suspensions of the diet , and number of NAVM , were similar in both not significant groups .
RESULTS	Neither differences were observed in the overall analysis secondary variables .
CONCLUSIONS	The metoclopramida in the NC , it is not effective in the decrease of the CGI , in the doses and time of treatment reflected in the study .

###24912062
OBJECTIVE	Whereas in the U.S. and Canada the Individual Placement and Support ( IPS ) model has proven to be highly effective in enhancing employment perspectives for persons with severe mental illnesses , the evidence base is less abundant in countries with a different socioeconomic climate .
OBJECTIVE	The aim of this study was to examine the effectiveness of IPS in the Dutch socioeconomic context .
METHODS	A multisite randomized controlled trial was performed following 151 persons with severe mental illnesses expressing an explicit wish for regular employment , comparing IPS with traditional vocational rehabilitation ( TVR ) .
METHODS	Primary outcome was the proportion of persons who were competitively employed over a period of 30 months .
METHODS	Secondary outcomes were self-reported quality of life , self-esteem and mental health .
METHODS	Additionally , the impact of being engaged in competitive employment on these secondary outcomes was examined .
RESULTS	In 30 months , 44 % of IPS participants found competitive work , compared with 25 % of participants supported by TVR .
RESULTS	No direct effect of IPS on mental health , self-esteem or quality of life was found .
RESULTS	Being competitively employed before follow-up measurements was significantly associated with an increase in mental health , self-esteem and quality of life .
CONCLUSIONS	This study strongly confirms that IPS is an effective method in helping people with severe mental illnesses find competitive work also in countries characterized by a relatively protective socioeconomic climate putting up unintended barriers to employment .
CONCLUSIONS	The implementation of IPS on a larger scale seems warranted , and new studies are needed on the mechanisms through which IPS works .

###24684263
BACKGROUND	The incidence of venous thromboembolism in children has increased significantly over the past 20 years .
BACKGROUND	Over the same period of time , there was an increase in the prevalence of obesity in the pediatric population .
BACKGROUND	Obesity is a known risk factor for VTE in adults , but little information is available in children .
METHODS	This study evaluates the relation between obesity and VTE using a retrospective , case-control design , comparing the body mass index ( BMI ) of patients admitted with a diagnosis of VTE versus patients admitted with other diagnoses , at a single institution , between 2007 and 2011 .
RESULTS	We studied 48 inpatients diagnosed with deep venous thrombosis or pulmonary embolism and a control group of 274 age and gender matched patients admitted with other diagnoses .
RESULTS	We found obese patients ( BMI > 95th percentile ) to have significantly higher risk of VTE ( odds ratio 2.1 , with 95 % CI 1.1-4 .2 ) than patients of normal weight ( BMI < 85th percentile ) .
RESULTS	Overweight patients ( BMI 85th-95th percentile ) did not demonstrate a significant change in risk .
RESULTS	Most of the VTE patients were adolescents and the majority of them had other identifiable risk factors for thrombosis .
CONCLUSIONS	This study establishes a correlation between obesity and VTE in a group of hospitalized children , showing a risk for VTE in obese children similar to the one described in much larger adult cohorts .

###25391864
OBJECTIVE	To evaluate the feasibility of low radiation exposure and low contrast medium volume for coronary CT angiography with High - pitch spiral acquisition mode of dual source CT. .
METHODS	135 patients whose BMI < 23 kg/m and heart rates < 65 bpm selected from 291 patients diagnosed of suspected CHD at our institution from September 2013 to February 2014 were randomly divided into 3 groups before CCTA , and there were 45 patients in each group .
METHODS	80 kV , Iodixanol ( 320 mgI/ml ) and sinogram affirmed iterative reconstruction ( SAFIRE ) were used in A group .
METHODS	80 kV , Iopamidol ( 370 mgI/ml ) and SAFIRE were used in B group .
METHODS	100 kV , Iodixanol and filtered back projection ( FBP ) were used in C group .
METHODS	Two radiologists assessed image quality with 5-piont scale subjectively and double-blind .
METHODS	Independent-Sample Test was used to analyze statistical significance of image quality including signal to noise ratio ( SNR ) and contrast to noise ratio ( CNR ) between A and B group or between A and C group .
METHODS	At the same time , Contrast medium dose statistical significance between A and B group and mean effective Radiation dose ( ED ) statistical significance between A and C were analyzed by the same way .
RESULTS	There were no significant difference of image quality including SNR and CNR of aortic root ( AO ) , left main coronary artery ( LM ) , left anterior descending artery ( LAD ) , circumflex coronary artery ( CX ) and right coronary artery ( RCA ) Between A and B group ( P = non-significant for all comparison ) , whereas Iodine in taken of A group decreased 14 % ( 17 600 mg vs 20 350 mg ) .
RESULTS	There were no significant difference of image quality including SNR and CNR of AO , LM , LAD , CX and RCA Between A and C group ( P = non-significant for all comparison ) , whereas mean ED of A group decreased 50 % ( 0.41 0.05 mSv vs 0.79 0.15 mSv ) .
CONCLUSIONS	The double low dose application which use High-pitch spiral mode , 80 kV , SAFIRE , and Iodixanol ( 320 mgI/ml ) can be used in those patients whose BMI < 23 kg/m and heart rates < 65 bpm to reduce the burden of radiation and contrast medium significantly , without compromising the image quality .

###25159626
BACKGROUND	The Fundamentals of Laparoscopic Surgery ( FLS ) trainer is currently the standard for training and evaluating basic laparoscopic skills .
BACKGROUND	However , its manual scoring system is time-consuming and subjective .
BACKGROUND	The Virtual Basic Laparoscopic Skill Trainer ( VBLaST ) is the virtual version of the FLS trainer which allows automatic and real time assessment of skill performance , as well as force feedback .
BACKGROUND	In this study , the VBLaST pattern cutting ( VBLaST-PC ) and ligating loop ( VBLaST-LL ) tasks were evaluated as part of a validation study .
BACKGROUND	We hypothesized that performance would be similar on the FLS and VBLaST trainers , and that subjects with more experience would perform better than those with less experience on both trainers .
METHODS	Fifty-five subjects with varying surgical experience were recruited at the Learning Center during the 2013 SAGES annual meeting and were divided into two groups : experts ( PGY 5 , surgical fellows and surgical attendings ) and novices ( PGY 1-4 ) .
METHODS	They were asked to perform the PC or the ligating loop task on the FLS and the VBLaST trainers .
METHODS	Their performance scores for each trainer were calculated and compared .
RESULTS	There were no significant differences between the FLS and VBLaST scores for either the PC or the ligating loop task .
RESULTS	Experts ' scores were significantly higher than the scores for novices on both trainers .
CONCLUSIONS	This study showed that the subjects ' performance on the VBLaST trainer was similar to the FLS performance for both tasks .
CONCLUSIONS	Both the VBLaST-PC and the VBLaST-LL tasks permitted discrimination between the novice and expert groups .
CONCLUSIONS	Although concurrent and discriminant validity has been established , further studies to establish convergent and predictive validity are needed .
CONCLUSIONS	Once validated as a training system for laparoscopic skills , the system is expected to overcome the current limitations of the FLS trainer .

###24485479
OBJECTIVE	Patients with major depressive disorder ( MDD ) often suffer from impaired declarative , episodic and working memory .
OBJECTIVE	Further , MDD is associated with alterations in the noradrenergic system .
OBJECTIVE	There is evidence that presynaptic 2 receptors that inhibit release of noradrenaline are upregulated in MDD .
OBJECTIVE	Results from our recent study demonstrated that increasing noradrenergic activity by blocking the 2 receptor with yohimbine leads to stronger memory consolidation in MDD patients .
OBJECTIVE	In the current study , we further examined the role of noradrenaline on memory in MDD by administering clonidine that activates presynaptic 2 receptors and thereby globally suppresses the noradrenergic output .
METHODS	In a placebo-controlled , within-subject crossover design , 20 patients with MDD and 20 healthy controls received either 0.15 mg of clonidine or placebo orally before memory testing .
METHODS	A word list paradigm ( memory consolidation ) , an autobiographical memory test ( retrieval ) and a working memory test were applied .
METHODS	Salivary alpha-amylase and blood pressure were measured .
RESULTS	Across groups , clonidine decreased blood pressure and alpha-amylase .
RESULTS	Clonidine impaired memory consolidation ( word list learning ) in depressed patients and controls .
RESULTS	Memory retrieval and working memory were not affected by clonidine .
CONCLUSIONS	Reducing noradrenergic activity had a specific effect on memory consolidation in patients with MDD and healthy controls .
CONCLUSIONS	The underlying mechanisms need further scrutiny .

###24571755
BACKGROUND	Enterovirus 71 ( EV71 ) is a major cause of hand , foot , and mouth disease in children and may be fatal .
BACKGROUND	A vaccine against EV71 is needed .
METHODS	We conducted a randomized , double-blind , placebo-controlled phase 3 trial involving healthy children 6 to 71 months of age in Guangxi Zhuang Autonomous Region , China .
METHODS	Two doses of an inactivated EV71 vaccine or placebo were administered intramuscularly , with a 4-week interval between doses , and children were monitored for up to 11 months .
METHODS	The primary end point was protection against hand , foot , and mouth disease caused by EV71 .
RESULTS	A total of 12,000 children were randomly assigned to receive vaccine or placebo .
RESULTS	Serum neutralizing antibodies were assessed in 549 children who received the vaccine .
RESULTS	The seroconversion rate was 100 % 4 weeks after the two vaccinations , with a geometric mean titer of 170.6 .
RESULTS	Over the course of two epidemic seasons , the vaccine efficacy was 97.4 % ( 95 % confidence interval [ CI ] , 92.9 to 99.0 ) according to the intention-to-treat analysis and 97.3 % ( 95 % CI , 92.6 to 99.0 ) according to the per-protocol analysis .
RESULTS	Adverse events , such as fever ( which occurred in 41.6 % of the participants who received vaccine vs. 35.2 % of those who received placebo ) , were significantly more common in the week after vaccination among children who received the vaccine than among those who received placebo .
CONCLUSIONS	The inactivated EV71 vaccine elicited EV71-specific immune responses and protection against EV71-associated hand , foot , and mouth disease .
CONCLUSIONS	( Funded by the National Basic Research Program and others ; ClinicalTrials.gov number , NCT01569581 . )

###25224684
BACKGROUND	Olfactory dysfunction is deemed to be a significant contributor to poor quality of life in chronic rhinosinusitis ( CRS ) .
OBJECTIVE	To assess and to compare the effectiveness of three modalities of corticosteroids administration in patients with CRS .
METHODS	A prospective randomized controlled study
METHODS	Thirty patients with CRS were randomized in three groups depending on the route of corticosteroids administration : 16 days by oral route ( Medrol ( Pfizer , Belgique ) , 32 mg/8 days -16 mg/4 days-8 mg/4 days ) ; nasal spray ( Rhinocort ( AstraZeneca , Belgique ) , 2 2 64 g/nostril ) ; or sonic nebulization ( Pulmicort ( AstraZeneca , Belgique ) , 2 1 mg/4 mL ) ( Sonic nebulizer , AOHBOX-NL11SN , DTF , France ) .
METHODS	Olfactory function was assessed using orthonasal threshold discrimination identification and retronasal psychophysical olfactory tests ( RNT ) before and after the treatment .
METHODS	Same intranasal modalities were previously tested for in vitro airways scintigraphic deposition .
RESULTS	In vitro differences in drug deposition pattern between both intranasal modalities were demonstrated .
RESULTS	Threshold discrimination identification and RNT were similar between three groups at baseline .
RESULTS	Threshold discrimination identification improved by 5.5 , 5.8 , and -1.1 for sonic nebulization , oral , and nasal spray groups , respectively ( P = 0.010 ) .
RESULTS	This improvement was clinically relevant for oral and nebulized administration .
RESULTS	It was similar between oral and nebulized administration but significantly higher than nasal spray administration .
RESULTS	Retronasal psychophysical olfactory tests improved similarly for the three groups ( P = 0.231 ) CONCLUSION : Effectiveness of sonic nebulized and oral administration is demonstrated on orthonasal olfactory .
RESULTS	The clinical benefit is better than with nasal spray .

###25041859
BACKGROUND	Patients with moderately to severely active ulcerative colitis occasionally do not respond to or lose initial response to maintenance dosing of anti-TNF therapy .
OBJECTIVE	To report the efficacy of escalation from every other week ( EOW ) to weekly adalimumab dosing in patients from the clinical trial ULTRA 2 ( NCT00408629 ) , by week 8 response ( i.e. response after adalimumab induction therapy ) .
METHODS	Week 52 remission , response , and mucosal healing rates were assessed in ULTRA 2 adalimumab-randomised patients who escalated to weekly dosing .
METHODS	Patients were stratified by week 8 response per partial Mayo score .
METHODS	Kaplan-Meier and logistic regression analyses estimated time to weekly dosing and defined predictors of escalation to weekly dosing , respectively .
METHODS	Adverse events were reported for patients receiving open-label adalimumab .
RESULTS	The rate of escalation to weekly dosing was 16.3 % ( 20/123 ) for week 8 responders and 38.4 % ( 48/125 ) for week 8 nonresponders .
RESULTS	Week 52 remission , response and mucosal healing rates with weekly dosing were 20 % , 45 % , and 45 % for week 8 responders and 2.1 % , 25 % and 29.2 % for nonresponders , respectively ( NRI ) .
RESULTS	The median time to weekly dosing was 288days for week 8 nonresponders and not estimable for responders .
RESULTS	Prior anti-TNF use was a significant predictor of escalation to weekly dosing .
RESULTS	Treatment-emergent adverse event rates were similar for patients receiving open-label EOW or weekly adalimumab .
CONCLUSIONS	Escalation to weekly adalimumab dosing demonstrated clinical benefits for patients who lost response to therapy and may be beneficial for patients not initially responding to induction therapy .
CONCLUSIONS	No new safety risks were identified with weekly dosing .

###24500080
BACKGROUND	Implementation intentions are effective for enhancing physical activity , but it is unknown how well these effects extend to older adults and/or are modified by cognitive variables .
OBJECTIVE	Our objective is to examine ( 1 ) the efficacy of an implementation intentions intervention for physical activity in older adult women and ( 2 ) to examine the moderating effects of executive function .
METHODS	Participants ( N = 75 , M age = 73.72 ) completed measures of executive function and were randomly assigned to weekly implementation intentions for physical activity ( experimental condition ) , implementation intentions for an unrelated behavior ( control condition ) , or no treatment .
METHODS	Baseline activity was measured by accelerometer and self-report ; follow-up activity was measured by weekly self-report .
RESULTS	Findings indicated a significant treatment effect for the experimental condition and a treatment by executive function interaction .
RESULTS	Specifically , participants with relatively stronger executive function benefited most from the experimental intervention .
CONCLUSIONS	Implementation intentions are effective for enhancing physical activity among older adult women , and the effects may be especially pronounced for those with relatively stronger executive function .

###24652692
OBJECTIVE	Vitamin D ( D ) status is reported to correlate negatively with insulin production and insulin sensitivity in patients with type 2 diabetes mellitus ( T2DM ) .
OBJECTIVE	However , few placebo-controlled intervention data are available .
OBJECTIVE	We aimed to assess the effect of large doses of parenteral D3 on glycosylated haemoglobin ( HbA ( c ) ) and estimates of insulin action ( homeostasis model assessment insulin resistance : HOMA-IR ) in patients with stable T2DM .
METHODS	We performed a prospective , randomised , double-blind , placebo-controlled pilot study at a single university care setting in Switzerland .
METHODS	Fifty-five patients of both genders with T2DM of more than 10 years were enrolled and randomised to either 300,000 IU D or placebo , intramuscularly .
METHODS	The primary endpoint was the intergroup difference in HbA ( c ) levels .
METHODS	Secondary endpoints were : changes in insulin sensitivity , albuminuria , calcium/phosphate metabolism , activity of the renin-aldosterone axis and changes in 24-hour ambulatory blood pressure values .
RESULTS	After 6 months of D supply , there was a significant intergroup difference in the change in HbA ( c ) levels ( relative change [ mean standard deviation ] +2.9 % 1.5 % in the D group vs +6.9 % 2.1 % the in placebo group , p = 0.041 ) as HOMA-IR decreased by 12.8 % 5.6 % in the D group and increased by 10 % 5.4 % in the placebo group ( intergroup difference , p = 0.032 ) .
RESULTS	Twenty-four-hour urinary albumin excretion decreased in the D group from 200 41 to 126 39 , p = 0.021 ) .
RESULTS	There was no significant intergroup difference for the other secondary endpoints .
CONCLUSIONS	D improved insulin sensitivity ( based on HOMA-IR ) and affected the course of HbA ( c ) positively compared with placebo in patients with T2DM .

###24998653
OBJECTIVE	To investigate the effect of atorvastatin on exercise tolerance in patients with diastolic dysfunction and exercise-induced hypertension .
METHODS	A randomized , double-blind , placebo-controlled prospective study was performed .
METHODS	Sixty patients with diastolic dysfunction ( mitral flow velocity E/A < 1 ) and exercise-induced hypertension ( SBP > 200 mm Hg ) treated with atorvastatin ( 20 mg q.d ) or placebo for 1 year .
METHODS	Cardiopulmonary exercise test and exercise blood pressure measurement were performed .
METHODS	Plasma B-natriuretic peptide ( BNP ) concentration at rest and at peak exercise , plasma high sensitive-C reaction protein ( hs-CRP ) and endothelin ( ET ) concentration were determined at baseline and after treatment .
RESULTS	After treatment by atorvastatin , the resting SBP , pulse pressure , the peak exercise SBP and BNP were significantly decreased ; and the exercise time , metabolic equivalent , maximal oxygen uptake and anaerobic threshold were increased .
RESULTS	All of these parameters had significant differences with baseline levels ( P < 0.05 ) and the rest pulse pressure , the peak exercise SBP and BNP , and the exercise time had significant differences compared with placebo treatment ( P < 0.05 ) .
RESULTS	Plasma concentrations of hs-CRP and ET were markedly reduced by atorvastatin treatment compared with baseline and placebo ( P < 0.05 ) .
RESULTS	No difference in above parameters was found before and after placebo treatment ( P > 0.05 ) .
CONCLUSIONS	In patients with diastolic dysfunction at rest and exercise-induced hypertension , atorvastatin can effectively reduce plasma hs-CRP and ET level , lower blood pressure and peak exercise SBP , decrease peak exercise plasma BNP concentration , and ultimately improve exercise tolerance .

###25192793
BACKGROUND	The inequity of randomising participants to control groups in randomised controlled trials ( RCTs ) is often considered inappropriate , especially for research trials that include vulnerable populations such as Indigenous peoples .
BACKGROUND	The Aboriginal and Torres Strait Islander Women 's Fitness Program conducted a trial that randomly assigned participants to ` active ' and ` waitlisted ' groups .
BACKGROUND	This paper reports on participant views of the randomisation protocol .
METHODS	A pragmatic RCT was conducted in an urban setting to assess the effectiveness of the 12-week Aboriginal and Torres Strait Islander Women 's Fitness Program on metabolic health outcomes and waist circumference .
METHODS	Qualitative interviews were conducted at follow-up , one of the objectives was to explore participant perspectives on the research protocol , including participant randomisation to ` Active ' and ` Waitlisted ' groups .
RESULTS	A total of 49 interviews were conducted ( 26 Active and 23 Waitlisted participants ) .
RESULTS	Two key factors influenced participant views on the protocol : 1 ) group assignment ; and 2 ) how well they understood the research design , including the justification for randomisation .
RESULTS	` Active ' participants were concerned about the inequity of the randomisation process but overall supported the study protocol .
RESULTS	Although most Waitlisted participants were disappointed about having to wait 12-months for the program , some participants derived motivation from being waitlisted , whilst others lost motivation .
RESULTS	Well-informed participants were more likely to express both support for the randomisation process and an understanding of the research benefits than participants not attending an information session prior to registration .
CONCLUSIONS	Participants were more accepting of the research protocol if it was clearly explained to them , if they understood the randomisation process and felt the randomisation was justified in terms of the potential for the results to benefit other Aboriginal and Torres Strait Islander women .
CONCLUSIONS	Our study suggests that the time and resources required to adequately explain the research protocol in research trials should not be undervalued .
BACKGROUND	Australian New Zealand Clinical Trials Registry ( ACTRN12610000224022 ) .

###24566244
BACKGROUND	The authors studied the interaction between sevoflurane and remifentanil on bispectral index ( BIS ) , state entropy ( SE ) , response entropy ( RE ) , Composite Variability Index , and Surgical Pleth Index , by using a response surface methodology .
BACKGROUND	The authors also studied the influence of stimulation on this interaction .
METHODS	Forty patients received combined concentrations of remifentanil ( 0 to 12 ng/ml ) and sevoflurane ( 0.5 to 3.5 vol % ) according to a crisscross design ( 160 concentration pairs ) .
METHODS	During pseudo-steady-state anesthesia , the pharmacodynamic measures were obtained before and after a series of noxious and nonnoxious stimulations .
METHODS	For the `` prestimulation '' and `` poststimulation '' BIS , SE , RE , Composite Variability Index , and Surgical Pleth Index , interaction models were applied to find the best fit , by using NONMEM 7.2.0 .
METHODS	( Icon Development Solutions , Hanover , MD ) .
RESULTS	The authors found an additive interaction between sevoflurane and remifentanil on BIS , SE , and RE .
RESULTS	For Composite Variability Index , a moderate synergism was found .
RESULTS	The comparison of pre - and poststimulation data revealed a shift of C50SEVO for BIS , SE , and RE , with a consistent increase of 0.3 vol % .
RESULTS	The Surgical Pleth Index data did not result in plausible parameter estimates , neither before nor after stimulation .
CONCLUSIONS	By combining pre - and poststimulation data , interaction models for BIS , SE , and RE demonstrate a consistent influence of `` stimulation '' on the pharmacodynamic relationship between sevoflurane and remifentanil .
CONCLUSIONS	Significant population variability exists for Composite Variability Index and Surgical Pleth Index .

###25963302
BACKGROUND	Abdominal aortic aneurysm ( AAA ) is thought to develop as a result of inflammatory processes in the aortic wall .
BACKGROUND	In particular , mast cells are believed to play a central role .
BACKGROUND	The AORTA trial was undertaken to investigate whether the mast cell inhibitor , pemirolast , could retard the growth of medium-sized AAAs .
BACKGROUND	In preclinical and clinical trials , pemirolast has been shown to inhibit antigen-induced allergic reactions .
METHODS	Inclusion criteria for the trial were patients with an AAA of 39-49mm in diameter on ultrasound imaging .
METHODS	Among exclusion criteria were previous aortic surgery , diabetes mellitus , and severe concomitant disease with a life expectancy of less than 2years .
METHODS	Included patients were treated with 10 , 25 or 40mg pemirolast , or matching placebo for 52weeks .
METHODS	The primary endpoint was change in aortic diameter as measured from leading edge adventitia at the anterior wall to leading edge adventitia at the posterior wall in systole .
METHODS	All ultrasound scans were read in a central imaging laboratory .
RESULTS	Some 326 patients ( mean age 708years ; 880 per cent men ) were included in the trial .
RESULTS	The overall mean growth rate was 242mm during the 12-month study .
RESULTS	There was no statistically significant difference in growth between patients receiving placebo and those in the three dose groups of pemirolast .
RESULTS	Similarly , there were no differences in adverse events .
CONCLUSIONS	Treatment with pemirolast did not retard the growth of medium-sized AAAs .
BACKGROUND	NCT01354184 ( https://www.clinicaltrials.gov ) .

###24307259
BACKGROUND	Little is known about how U.S. physicians political affiliations , specialties , or sense of social responsibility relate to their reactions to health care reform legislation .
OBJECTIVE	To assess U.S. physicians impressions about the direction of U.S. health care under the Affordable Care Act ( ACA ) , whether that legislation will make reimbursement more or less fair , and examine how those judgments relate to political affiliation and perceived social responsibility .
METHODS	A cross-sectional , mailed , self-reported survey .
METHODS	Simple random sample of 3,897 U.S.physicians .
METHODS	Views on the ACA in general , reimbursement under the ACA in particular , and perceived social responsibility .
RESULTS	Among 2,556 physicians who responded ( RR2 : 65 % ) , approximately two out of five ( 41 % ) believed that the ACA will turn U.S. health care in the right direction and make physician reimbursement less fair ( 44 % ) .
RESULTS	Seventy-two percent of physicians endorsed a general professional obligation to address societal health policy issues , 65 % agreed that every physician is professionally obligated to care for the uninsured or underinsured , and half ( 55 % ) were willing to accept limits on coverage for expensive drugs and procedures for the sake of expanding access to basic health care .
RESULTS	In multivariable analyses , liberals and independents were both substantially more likely to endorse the ACA ( OR 33.0 [ 95 % CI , 23.646.2 ] ; OR 5.0 [ 95 % CI , 3.76.8 ] , respectively ) , as were physicians reporting a salary ( OR 1.7 [ 95 % CI , 1.22.5 ] ) or salary plus bonus ( OR 1.4 [ 95 % CI , 1.11.9 ) compensation type .
RESULTS	In the same multivariate models , those who agreed that addressing societal health policy issues are within the scope of their professional obligations ( OR 1.5 [ 95 % CI , 1.02.0 ] ) , who believe physicians are professionally obligated to care for the uninsured / under-insured ( OR 1.7 [ 95 % CI ,1.32.4 ] ) , and who agreed with limiting coverage for expensive drugs and procedures to expand insurance coverage ( OR 2.3 [ 95 % CI , 1.83.0 ] ) , were all significantly more likely to endorse the ACA .
RESULTS	Surgeons and procedural specialists were less likely to endorse it ( OR 0.5 [ 95 % CI , 0.40.7 ] , OR 0.6 [ 95 % CI , 0.50.9 ] , respectively ) .
CONCLUSIONS	Significant subsets of U.S. physicians express concerns about the direction of U.S. health care under recent health care reform legislation .
CONCLUSIONS	Those opinions appear intertwined with political affiliation , type of medical specialty , as well as perceived social responsibility .

###24535350
OBJECTIVE	To evaluate the influence of different alveolar bone heights on fracture resistance and pattern of post and core restored maxillary premolars .
METHODS	Forty-eight maxillary premolars were randomly divided into 6 groups ( 8 teeth in each group ) for different alveolar bone heights and different post and core materials .
METHODS	Group A : fiber post and core and normal alveolar bone height .
METHODS	Group B : Ni-Cr cast post and core and normal alveolar bone height .
METHODS	Group C : fiber post and core with 2 mm alveolar bone height reduction .
METHODS	Group D : Ni-Cr cast post and core with 2 mm alveolar bone height reduction .
METHODS	Group E : fiber post and core with 4 mm alveolar bone height reduction .
METHODS	Group F : Ni-Cr cast post and core with 4 mm alveolar bone height reduction .
METHODS	All of the teeth were restored with Ni-Cr cast crowns .
METHODS	Fracture resistances were tested and the failure modes were examined .
RESULTS	The mean fracture resistances were ( 762.49 84.91 ) N for group A , ( 794.26 72.61 ) N for group B , ( 517.69 80.30 ) N for group C , ( 543.50 62.88 ) N for group D , ( 219.91 43.20 ) N for group E , and ( 196.16 41.08 ) N for group F.
RESULTS	The ratios of favorable fractures were 100.0 % for group A , 37.5 % for group B , 75.0 % for group C , 12.5 % for group D , 50.0 % for group E , and 0 for group F.
CONCLUSIONS	The alveolar bone height has a significant impact on fracture resistance and modes of post and core restored maxillary premolars .
CONCLUSIONS	With the reduction of alveolar bone height , the fracture decreases and the fracture mode tends to be unfavorable .

###24337491
OBJECTIVE	Computed tomography ( CT ) is used to assess for fracture after knee trauma , but identification of ligamentous injuries may also be beneficial .
OBJECTIVE	Our purpose is to assess the potential of dual-energy computed tomography ( DECT ) for the detection of complete anterior cruciate ligament ( ACL ) disruption .
METHODS	Sixteen patients with unilateral traumatic ACL disruption ( average of 58 days following trauma ) confirmed by MRI , and 11 control patients without trauma , underwent DECT of both knees .
METHODS	For each knee , axial , sagittal , and oblique sagittal images ( with DECT bone removal , single-energy ( SE ) bone removal , and DECT tendon-specific color mapping ) were reconstructed .
METHODS	Four musculoskeletal radiologists randomly evaluated the 324 DECT reconstructed series ( 54 knees with 6 displays ) separately , to assess for ACL disruption using a five-point scale ( 1 = definitely not torn , to 5 = definitely torn ) .
METHODS	ROC analysis was used to compare performance across readers and displays .
RESULTS	Sagittal oblique displays ( mixed kV soft tissue , SE bone removal , and DECT bone removal ) demonstrated higher areas under the curve for ACL disruption ( AUC = 0.95 , 0.93 and 0.95 respectively ) without significant differences in performance between readers ( p > 0.23 ) .
RESULTS	Inter-reader agreement was also better for these display methods ( ICC range 0.62-0 .69 ) compared with other techniques ( ICC range 0.41-0 .57 ) .
RESULTS	Mean sensitivity for ACL disruption was worst for DECT tendon-specific color map and axial images ( 24 % and 63 % respectively ) .
CONCLUSIONS	DECT knee images with oblique sagittal reconstructions using either mixedkV or bone removal displays ( either DECT or SE ) depict ACL disruption in the subacute or chronic setting with reliable identification by musculoskeletal radiologists .

###24804884
OBJECTIVE	A treatment-as-usual randomized wait-list controlled trial was conducted to investigate the feasibility and impact of an online synchronous Mindfulness-Based Cancer Recovery ( MBCR ) group program for underserved distressed cancer survivors .
METHODS	Sixty-two men and women exhibiting moderate to high distress within 3 years of completing primary cancer treatment without access to in-person MBCR were randomized to either immediate online MBCR ( n = 30 ) or to wait for the next available program ( n = 32 ) .
METHODS	Participants completed questionnaires preintervention and postintervention or wait period online .
METHODS	Program evaluations were completed after MBCR .
METHODS	Feasibility was tracked through monitoring eligibility and participation through the protocol .
METHODS	Intent-to-treat mixed-model analyses for repeated measures were conducted .
RESULTS	Feasibility targets for recruitment and retention were achieved , and participants were satisfied and would recommend online MBCR .
RESULTS	There were significant improvements and moderate Cohen d effect sizes in the online MBCR group relative to controls after MBCR for total scores of mood disturbance ( d = 0.44 , p = .049 ) , stress symptoms ( d = 0.49 , p = .021 ) , spirituality ( d = 0.37 , p = .040 ) , and mindfully acting with awareness ( d = 0.50 , p = .026 ) .
RESULTS	Main effects of time were observed for posttraumatic growth and remaining mindfulness facets .
CONCLUSIONS	Results provide evidence for the feasibility and efficacy of an online adaptation of MBCR for the reduction of mood disturbance and stress symptoms , as well as an increase in spirituality and mindfully acting with awareness compared with a treatment-as-usual wait-list .
CONCLUSIONS	Future study using larger active control RCT designs is warranted .
BACKGROUND	Clinical Trials.gov : NCT01476891 .

###25327222
OBJECTIVE	Lemongrass oil ( LG ) has been reported as being effective against bacteria embedded within the biofilm .
OBJECTIVE	The aims of this study were to investigate antimicrobial activity against common odourigenic micro-organisms , the safety and efficacy of LG mouthrinse on oral malodour in healthy volunteers .
RESULTS	Antimicrobial activity of LG mouthrinse was examined against common odourigenic micro-organisms using broth microdilution assay and the disc diffusion method .
RESULTS	A randomised double-blind clinical study was performed in 20 healthy volunteers .
RESULTS	Volatile sulphur compounds ( VSCs ) level was measured using a Halimeter on day 0 and day 8 in each volunteer .
RESULTS	The results showed that LG mouthrinse was effective against Aggregatibacter actinomycetemcomitans ATCC43718 and Porphyromonas gingivalis W50 but less effective against Streptococcus mutans ATCC 25175 .
RESULTS	In addition , the mouthrinse significantly reduced VSCs on day 8 .
CONCLUSIONS	LG mouthrinse was able to reduce oral malodour and appeared to be safe .
CONCLUSIONS	The overall satisfaction of the mouthrinse was acceptable .
CONCLUSIONS	However , the spiciness and taste of the mouthrinse need to be improved .
CONCLUSIONS	This study demonstrated that the LG mouthrinse significantly reduced oral malodour .
CONCLUSIONS	This mouthrinse would be another alternative mouthrinse choice for prevention of malodour , plaque and gingivitis .

###24831596
OBJECTIVE	The goal of aneurysm treatment is occlusion of an aneurysm without morbidity or mortality .
OBJECTIVE	Using well-established , traditional endovascular techniques , this is generally achievable with a high level of safety and efficacy .
OBJECTIVE	These techniques involve either constructive treatment of the aneurysm ( coils with or without an intravascular stent ) or deconstruction ( coil occlusion ) of the aneurysm and the parent artery .
OBJECTIVE	While established as safe and efficacious , the constructive treatment of large and giant aneurysms with coils has typically been associated with relatively lower rates of complete occlusion and higher rates of recurrence .
OBJECTIVE	Parent artery deconstruction , though immediately efficacious in achieving complete and durable occlusion , does require occlusion of a major intracranial blood vessel and is associated with risk of stroke .
METHODS	Flow diversion represents a new technology that can be used to constructively treat large and giant aneurysms .
METHODS	Once excluded successfully , the vessel reconstruction and aneurysm occlusion appears durable .
METHODS	The ability to definitively reconstruct cerebral blood vessels is an attractive approach to these large and giant complex aneurysms and allows the treatment of some aneurysms which were previously not amenable to other therapies .
METHODS	By comparison , conventional coiling techniques have traditionally been used for endovascular treatment of large aneurysms .
METHODS	Large and giant aneurysms that are amenable to either flow diversion or traditional endovascular treatment will be randomized to either therapy with FDA ( or appropriate regulatory body ) approved devices .
RESULTS	The trial is currently enrolling and results of the data are pending the completion of enrollment and follow-up .
CONCLUSIONS	This paper details the trial design of the LARGE trial , a blinded , prospective randomized trial of large anterior circulation aneurysms amenable to either traditional endovascular treatments using coils or reconstruction with flow diverters .

###25449185
BACKGROUND	Sixty percent of cancer survivors are 65years of age or older .
BACKGROUND	Cancer and its treatments lead to cancer-related fatigue and many other side effects , in turn , creating substantial global side-effect burden ( total burden from all side effects ) which , ultimately , compromises functional independence and quality of life .
BACKGROUND	Various modes of exercise , such as yoga , reduce cancer-related fatigue and global side-effect burden in younger cancer survivors , but no studies have specifically examined the effects of yoga on older cancer survivors .
OBJECTIVE	The purpose of this study was to assess the effects of a 4-week yoga intervention ( Yoga for Cancer Survivors : YOCAS ) on overall cancer-related fatigue , and due to its multidimensional nature , the subdomains of cancer-related fatigue ( general , physical , emotional , and mental ) and global side-effect burden in older cancer survivors .
METHODS	We conducted a secondary analysis on data from a multicenter phase III randomized controlled clinical trial with 2 arms ( standard care and standard care plus a 4-week YOCAS intervention ) .
METHODS	The sample for this secondary analysis was 97 older cancer survivors ( 60years of age ) , between 2months and 2years post-treatment , who participated in the original trial .
RESULTS	Participants in the YOCAS intervention arm reported significantly lower cancer-related fatigue , physical fatigue , mental fatigue , and global side-effect burden than participants in the standard care arm following the 4-week intervention period ( p < 0.05 ) .
CONCLUSIONS	YOCAS is an effective standardized yoga intervention for reducing cancer-related fatigue , physical fatigue , mental fatigue , and global side-effect burden among older cancer survivors .

###25845223
OBJECTIVE	To observe the clinical effect of acupuncture therapy combined with Lipitor in the treatment of primary hyperlipidemia ( spleen deficiency and food stagnation type ) .
METHODS	Sixty primary hyperlipidemia patients ( spleen deficiency and food stagnation type ) were equally randomized into medication group and acupuncture plus medication group .
METHODS	Patients of both groups were treated by oral administration of Lipitor ( 20 mg/tablet , one tablet per day ) for 6 weeks .
METHODS	Manual acupuncture stimulation was applied to Baihui ( GV 20 ) , Zhongwan ( CV 12 ) , and bilateral Zusanli ( ST 36 ) , Sanyinjiao ( SP 6 ) , Yin-lingquan ( SP 9 ) and Fenglong ( ST 40 ) for 40 min , twice daily for 6 weeks except the weekends .
METHODS	Serum total cholesterol ( TC ) , triglyceride ( TG ) , high density lipoprotein-cholesterol ( HDL-C ) , low density lipoprotein-cholesterol ( LDL-C ) were detected by using a full-automatic biochemistry analyzer before and after the treatment .
METHODS	The therapeutic effect was assessed according to the standards described in `` Guide Principles for Clinical Researches of New Chinese Herbal Drugs '' .
RESULTS	After the treatment , the levels of serum TC , TG of the two groups were significantly decreased in comparison with pre-treatment in the same one group ( P < 0.05 ) , and the therapeutic effect of the acupuncture + medication group was significantly superior to that of simple medication group in lowering serum TC , TG and LDL-C levels and heightening HDL-C levels ( P < 0.05 ) .
RESULTS	Of the two 30 cases in the medication and acupuncture + medication groups , 2 ( 6.7 % ) and 7 ( 23.3 % ) were basically controlled in their blood-lipid levels , 10 ( 33.3 % ) and 15 ( 50.0 % ) had a marked improvement , 10 ( 33.3 % ) and 6 ( 20.0 % ) were improved , and 8 ( 26.7 % ) and 2 ( 6.7 % ) were invalid , with the effective rates being 73.3 % and 93.3 % , respectively .
CONCLUSIONS	Acupuncture combined with administration of Lipitor is effective in improving primary hyperlipidemia in patients , which is superior to administration of simple Lipitor .

###25468636
OBJECTIVE	To evaluate the feasibility of using a reduced radiation dose and reduced iodine intake ( i.e. , `` double low '' : low tube voltage/low iodine dose contrast agent ) scanning protocol and the adaptive iterative dose reduction ( AIDR ) reconstruction algorithm in coronary heart disease ( CHD ) patients with a BMI of 26-30kg / m ( 2 ) .
METHODS	One-hundred and seventy-nine consecutive CHD patients with a body mass index > 26kg/m but < 30kg/m were randomly assigned to two groups ( group A : 53 men , 39 women , average age 61.8311.84 years , and group B : 40 men , 47 women , average age 62.2511.37 years ) based on tube voltage , contrast agent , and algorithm used .
METHODS	Group A underwent the `` double low '' protocol ( iodixanol at 270mg iodine/ml , 100kVp tube voltage , and AIDR ) .
METHODS	Group B received the conventional protocol [ iopamidol at 370mg iodine/ml , 120kVp tube voltage , and filtered back projection ( FBP ) ] .
RESULTS	The volume CT dose index ( CTDIvol ) , dose-length product ( DLP ) , effective dose ( ED ) , and iodine intake of patients in `` double low '' group A were significantly lower than the `` conventional '' group B ( p < 0.001 ) .
RESULTS	The mean intraluminal attenuation and contrast enhancement in group A were also significantly less than group B ( p < 0.001 ) , whereas the image noise using AIDR in group A was significantly lower than group B using FBP ( p < 0.001 ) .
RESULTS	However , the signal-to - noise ratio ( SNR ) , contrast-to-noise ratio ( CNR ) , and image-quality scores between the two groups were comparable .
CONCLUSIONS	Use of 320-row CT with a `` double low '' scanning protocol for CCTA in patients with a BMI of 26-30kg / m ( 2 ) not only provided images of diagnostic quality but also reduced both radiation dose and iodine intake during scanning .

###24560581
BACKGROUND	A self-enhancing loop between impaired inhibitory control under alcohol and alcohol consumption has been proposed as a possible mechanism underlying dysfunctional drinking in susceptible people .
BACKGROUND	However , the neural underpinnings of alcohol-induced impairment of inhibitory control are widely unknown .
METHODS	We measured inhibitory control in 50 young adults with a stop-signal task during functional magnetic resonance imaging .
METHODS	In a single-blind placebo-controlled cross-over design , all participants performed the stop-signal task once under alcohol with a breath alcohol concentration of .6 g/kg and once under placebo .
METHODS	In addition , alcohol consumption was assessed with a free-access alcohol self-administration paradigm in the same participants .
RESULTS	Inhibitory control was robustly decreased under alcohol compared with placebo , indicated by longer stop-signal reaction times .
RESULTS	On the neural level , impaired inhibitory control under alcohol was associated with attenuated brain responses in the right fronto-temporal portion of the inhibition network that supports the attentional capture of infrequent stop-signals and subsequent updating of action plans from response execution to inhibition .
RESULTS	Furthermore , the extent of alcohol-induced impairment of inhibitory control predicted free-access alcohol consumption .
CONCLUSIONS	We suggest that during inhibitory control alcohol affects cognitive processes preceding actual motor inhibition .
CONCLUSIONS	Under alcohol , decreased brain responses in right fronto-temporal areas might slow down the attentional capture of infrequent stop-signals and subsequent updating of action plans , which leads to impaired inhibitory control .
CONCLUSIONS	In turn , pronounced alcohol-induced impairment of inhibitory control might enhance alcohol consumption in young adults , which might promote future alcohol problems .

###24372991
BACKGROUND	Ex vivo evidence suggests that cyclo-oxygenase ( COX ) 2-preferential inhibitor nonsteroidal anti-inflammatory drugs ( NSAIDs ) , such as meloxicam , have a less detrimental effect on intestinal healing than flunixin meglumine ( FM ) .
BACKGROUND	Whether this translates to a beneficial effect in horses with naturally occurring strangulating small intestinal ( SSI ) lesions is unknown .
OBJECTIVE	To compare the clinical outcome of horses with naturally occurring SSI lesions treated with meloxicam or FM .
METHODS	Randomised prospective study .
METHODS	Cases presenting to the Royal Veterinary College Equine Referral Hospital and Bell Equine Veterinary Clinic during 2010 and 2011 in which an SSI lesion was identified at exploratory laparotomy were eligible for inclusion .
METHODS	Horses received either 1.1 mg/kg bwt FM or 0.6 mg/kg bwt meloxicam i.v. q. 12h .
METHODS	Clinical outcomes and clinical and laboratory parameters associated with endotoxaemia were compared between groups .
RESULTS	Sixty cases were enrolled , 32 horses received FM and 28 received meloxicam .
RESULTS	There was no difference in signalment , physical examination or surgical factors between groups .
RESULTS	The overall survival to discharge was 81 % ; there was no difference in survival ( P = 0.14 ) or incidence of post operative ileus ( P = 0.25 ) between groups .
RESULTS	There was no significant difference between the plasma lipopolysaccharide ( LPS ) concentrations at 0h ( P = 0.18 ) or 48h ( P = 0.60 ) ; however , there was a significant difference between neutrophil count at 48h ( P < 0.05 ) and at 96h ( P < 0.01 ) with significantly greater cell numbers in horses receiving meloxicam compared with FM .
RESULTS	Blinded pain score evaluation showed that more horses receiving meloxicam showed gross signs of pain than those treated with FM ( P = 0.04 ) .
CONCLUSIONS	Nonsteroidal anti-inflammatory drug choice did not affect major clinical outcomes in horses with SSI lesions but had some effects on signs of pain .
CONCLUSIONS	This study provides no evidence to recommend one NSAID treatment above another based on survival or the incidence of ileus ; however , evaluation of a larger number of cases is required .

###25231604
BACKGROUND	Long-term ventilated intensive care patients frequently require tracheostomy .
BACKGROUND	Although overall risks are low , serious immediate and late complications still arise .
BACKGROUND	Real-time ultrasound guidance has been proposed to decrease complications and improve the accuracy of the tracheal puncture .
BACKGROUND	We aimed to compare the procedural safety and efficacy of real-time ultrasound guidance with the traditional landmark approach during percutaneous dilatational tracheostomy ( PDT ) .
METHODS	A total of 50 patients undergoing PDT for clinical indications were randomly assigned , after obtaining informed consent , to have the tracheal puncture procedure carried out using either traditional anatomical landmarks or real-time ultrasound guidance .
METHODS	Puncture position was recorded via bronchoscopy .
METHODS	Blinded assessors determined in a standardised fashion the deviation of the puncture off midline and whether appropriate longitudinal position between the first and fourth tracheal rings was achieved .
METHODS	Procedural safety and efficacy data , including complications and number of puncture attempts required , were collected .
RESULTS	In total , 47 data sets were evaluable .
RESULTS	Real-time ultrasound guidance resulted in significantly more accurate tracheal puncture .
RESULTS	Mean deviation from midline was 153 versus 355 ( P = 0.001 ) .
RESULTS	The proportion of appropriate punctures , defined a priori as 030 from midline , was significantly higher : 20 ( 87 % ) of 23 versus 12 ( 50 % ) of 24 ( RR = 1.74 ; 95 % CI = 1.13 to 2.67 ; P = 0.006 ) .
RESULTS	First-pass success rate was 20 ( 87 % ) of 23 in the ultrasound group and 14 ( 58 % ) of 24 in the landmark group ( RR = 1.49 ; 95 % CI = 1.03 to 2.17 ; P = 0.028 ) .
RESULTS	The observed decrease in procedural complications was not statistically significant : 5 ( 22 % ) of 23 in the ultrasound group versus 9 ( 37 % ) of 24 in the landmark group ( RR = 0.58 ; 95 % CI = 0.23 to 1.47 ; P = 0.24 ) .
CONCLUSIONS	Ultrasound guidance significantly improved the rate of first-pass puncture and puncture accuracy .
CONCLUSIONS	Fewer procedural complications were observed ; however , this did not reach statistical significance .
CONCLUSIONS	These results support wider general use of real-time ultrasound guidance as an additional tool to improve PDT .
BACKGROUND	Australian New Zealand Clinical Trials Registry ID : ACTRN12611000237987 ( registered 4 March 2011 ) .

###25052420
BACKGROUND	The United Nations Millennium Development Goals include targets for the health of children under five years old .
BACKGROUND	Poor health is linked to poverty and microfinance initiatives are economic interventions that may improve health by breaking the cycle of poverty .
BACKGROUND	However , there is a lack of reliable evidence to support this .
BACKGROUND	In addition , microfinance schemes may have adverse effects on health , for example due to increased indebtedness .
BACKGROUND	Rojiroti UK and the Centre for Promoting Sustainable Livelihood run an innovative microfinance scheme that provides microcredit via women 's self-help groups ( SHGs ) .
BACKGROUND	This pilot study , conducted in rural Bihar ( India ) , will establish whether it is feasible to collect anthropometric and mortality data on children under five years old and to conduct a limited cluster randomized trial of the Rojiroti intervention .
METHODS	We have designed a cluster randomized trial in which participating tolas ( small communities within villages ) will be randomized to either receive early ( SHGs and microfinance at baseline ) or late intervention ( SHGs and microfinance after 18months ) .
METHODS	Using predesigned questionnaires , demographic , and mortality data for the last year and information about participating mothers and their children will be collected and the weight , height , and mid upper arm circumference ( MUAC ) of children will be measured at baseline and at 18months .
METHODS	The late intervention group will establish SHGs and microfinance support at this point and data collection will be repeated at 36months .
METHODS	The primary outcome measure will be the mean weight for height z-score of children under five years old in the early and late intervention tolas at 18months .
METHODS	Secondary outcome measures will be the mortality rate , mean weight for age , height for age , prevalence of underweight , stunting , and wasting among children under five years of age .
CONCLUSIONS	Despite economic progress , marked inequalities in child health persist in India and Bihar is one of the worst affected states .
CONCLUSIONS	There is a need to evaluate programs that may alleviate poverty and improve health .
CONCLUSIONS	This study will help to inform the design of a definitive trial to determine if the Rojiroti scheme can improve the nutrition and survival of children under five years of age in deprived rural communities .
BACKGROUND	Clinicaltrials.gov ( study ID : NCT01845545 ) .
BACKGROUND	Registered on 24 April 2013 .

###24368436
BACKGROUND	The potential for small-quantity lipid-based nutrient supplements ( LNS ) to promote growth and development after 6 mo of age is currently being investigated .
BACKGROUND	Because infants self-regulate energy intake , consumption of LNS may reduce breast milk intake and potentially decrease the beneficial effects of breast milk .
OBJECTIVE	The objective was to test the hypothesis that the breast milk intake of 9 - to 10-mo-old rural Malawian infants receiving LNS would not be lower than that of infants receiving no supplementation .
METHODS	This was a substudy of the International Lipid-based Nutrient Supplements ( iLiNS ) DOSE trial , in which 6-mo-old infants were randomly assigned to receive 10 , 20 , or 40 g LNS/d containing 56 , 117 , or 241 kcal/d , respectively , or no LNS until 18 mo of age .
METHODS	A subset was randomly selected to estimate breast milk intake at 9-10 mo of age with the dose-to-mother deuterium oxide dilution method .
METHODS	The noninferiority margin was < 10 % of total energy requirements .
RESULTS	Baseline characteristics ( n = 376 ) were similar across groups .
RESULTS	The mean ( SD ) daily breast milk intake of unsupplemented infants was 730 226 g.
RESULTS	The differences ( 95 % CIs ) in mean intake of infants provided with 10 , 20 , or 40 g LNS/d , compared with controls , were +62 ( -18 , +143 ) , +30 ( -40 , +99 ) , and +2 ( -68 , +72 ) g/d , respectively .
RESULTS	Non-breast milk oral water intake did not differ by group ( P = 0.39 ) and was inversely ( r = -0.22 , P < 0.01 ) associated with breast milk intake .
CONCLUSIONS	In this rural Malawian population , breast milk intake at 9-10 mo of age was not reduced by supplementation with complementary foods with 10-40 g LNS/d .

###24616359
OBJECTIVE	In the United States , data from federally funded genomics studies are stored in national databases , which may be accessible to anyone online ( public release ) or only to qualified researchers ( restricted release ) .
OBJECTIVE	The availability of such data exposes participants to privacy risk and limits the ability to withdraw from research .
OBJECTIVE	This exposure is especially challenging for pediatric participants , who are enrolled in studies with parental permission .
OBJECTIVE	The current study examines genomic research participants ' attitudes to explore differences in data sharing ( DS ) preferences between parents of pediatric patients and adult patients .
METHODS	A total of 113 parents of pediatric patients and 196 adult participants from 6 genomics studies were randomly assigned to 3 experimental consent forms .
METHODS	Participants were invited to a follow-up structured interview exploring DS preferences , study understanding , and attitudes .
METHODS	Descriptive analyses and regression models were built on responses .
RESULTS	Most parents ( 73.5 % ) and adult participants ( 90.3 % ) ultimately consented to broad public release .
RESULTS	However , parents were significantly more restrictive in their data release decisions , not because of understanding or perceived benefits of participation but rather autonomy and control .
RESULTS	Parents want to be more involved in the decision about DS and are significantly more concerned than adult participants about unknown future risks .
CONCLUSIONS	Parents have the same altruistic motivations and grasp of genomics studies as adult participants .
CONCLUSIONS	However , they are more concerned about future risks to their child , which probably motivates them to choose more restrictive DS options , but only when such options are made available .

###24586912
OBJECTIVE	To evaluate the safety , tolerability and immunogenicity of three different doses ( 5 , 25 and 50 g ) of the novel antituberculous vaccine RUTI compared to placebo in subjects with latent tuberculosis infection .
RESULTS	Double-blind , randomized , placebo-controlled Phase II Clinical Trial ( 95 patients randomized ) .
RESULTS	Three different RUTI doses and placebo were tested , randomized both in HIV-positive ( n = 47 ) and HIV-negative subjects ( n = 48 ) , after completion of one month isoniazid ( INH ) pre-vaccination .
RESULTS	Each subject received two vaccine administrations , 28 Days apart .
RESULTS	Five patients withdrew and 90 patients completed the study .
RESULTS	Assessment of safety showed no deaths during study .
RESULTS	Two subjects had serious adverse events one had a retinal detachment while taking INH and was not randomized and the other had a severe local injection site abscess on each arm and was hospitalized ; causality was assessed as very likely and by the end of the study the outcome had resolved .
RESULTS	All the patients except 5 ( 21 % ) patients of the placebo group ( 3 HIV + and 2 HIV - ) reported at least one adverse event ( AE ) during the study .
RESULTS	The most frequently occurring AEs among RUTI recipients were ( % in HIV + / - ) : injection site reactions [ erythema ( 91/92 ) , induration ( 94/92 ) , local nodules ( 46/25 ) , local pain ( 66/75 ) , sterile abscess ( 6/6 ) , swelling ( 74/83 ) , ulcer ( 20/11 ) , headache ( 17/22 ) and nasopharyngitis ( 20/5 ) ] .
RESULTS	These events were mostly mild and well tolerated .
RESULTS	Overall , a polyantigenic response was observed , which differed by HIV - status .
RESULTS	The best polyantigenic response was obtained when administrating 25 g RUTI , especially in HIV-positive subjects which was not increased after the second inoculation .
CONCLUSIONS	This Phase II clinical trial demonstrates reasonable tolerability of RUTI .
CONCLUSIONS	The immunogenicity profile of RUTI vaccine in LTBI subjects , even being variable among groups , allows us considering one single injection of one of the highest doses in future trials , preceded by an extended safety clinical phase .
BACKGROUND	ClinicalTrials.gov NCT01136161 .

###24582071
BACKGROUND	Regular monitoring of the international normalized ratio ( INR ) is crucial for dose adjustment of vitamin K antagonists ( VKA ) to maximize time in therapeutic range ( TTR ) .
BACKGROUND	We compared the use of a mobile electronic assistant INRPlus which proposes patient-specific fluindione doses , to standard fluindione management in a cluster randomized controlled study .
METHODS	Twenty clusters of six general practitioners were randomized to adjust fluindione doses in VKA-treated patients either using INRPlus or according to routine practice .
METHODS	TTR was measured over 6 months , along with time spent above or below the recommended INR range , frequency of measurements and related complications .
RESULTS	Of the 595 included patients , 551 were assessable ( 259 INRPlus , 292 control ) and had a mean of 1.6 INR measurements/month .
RESULTS	TTR was not significantly different between the two groups , 72.7 % [ Q1 : 58.1 % ; Q3 : 90 % ] in INRPlus patients and 71.2 % [ Q1 : 54.8 % ; Q3 : 88.2 % ] in control patients ( p = 0.445 ) .
RESULTS	At least 60 % time within reference ranges was reported in 73.4 % of INRPlus patients and 67.1 % of control patients ( relative risk 1.09 , 95 % CI 0.98-1 .22 , p = 0.115 ) .
RESULTS	No significant differences were reported between the two groups for time outside reference ranges , frequency of measurements or complications .
RESULTS	Eighty-two percent ( 82 % ) of patients complying with INRPlus-proposed doses spent more than 60 % of TTR versus 66.9 % of non-compliant patients and 67.1 % of reference patients .
CONCLUSIONS	In this trial , the use of the INRPlus electronic assistant resulted in a non-significant improvement in TTR that may be due to a higher than expected TTR in the control group .

###24342427
BACKGROUND	Hospital malnutrition is a highly prevalent problem that affects patient morbidity and mortality resulting in longer hospital stays and increased healthcare costs .
BACKGROUND	Although there is no single nutritional screening method , subjective global assessment ( SGA ) may be a useful , inexpensive , and easily reproducible tool .
METHODS	A cross-sectional , observational , randomized study was conducted in 197 patients in a tertiary hospital .
METHODS	SGA , anthropometric data , and biochemical parameters were used to assess the nutritional status of study patients .
RESULTS	Fifty percent of subjects were malnourished according to SGA .
RESULTS	A higher prevalence of malnutrition was found in medical ( 53 % ) as compared to surgical departments ( 47 % ) .
RESULTS	Half the subjects ( 50 % ) had malnutrition by SGA , but only 37.8 % received nutritional treatment during their hospital stay .
RESULTS	Mean hospital stay was longer for patients malnourished ( 13.5 days ) or at risk of malnutrition ( 12.1 days ) as compared to well nourished subjects ( 6.97 days ) .
RESULTS	SGA significantly correlated ( P < .012 ) with anthropometric and biochemical malnutrition parameters .
CONCLUSIONS	Prevalence of hospital malnutrition is very high in both medical and surgical departments and is inadequately treated .
CONCLUSIONS	SGA is a useful tool for screening hospital malnutrition because of its high degree of correlation with anthropometric and biochemical parameters .

###24957950
OBJECTIVE	To compare the immunogenicity and safety between full-dose ( 15 g ) intramuscular ( i.m. ) and full-dose ( 15 g ) intradermal ( i.d. ) immunization of the trivalent influenza vaccine in nursing home older adults .
METHODS	A single-center , randomized , controlled , open-label , parallel group trial from October 2013 to April 2014 .
METHODS	Nine nursing homes in Hong Kong .
METHODS	Hundred nursing home older adults ( mean age : 82.9 7.4 years ) .
METHODS	Fifty received i.d. ( Intanza ) and 50 received i.m. ( Vaxigrip ) vaccination .
METHODS	Baseline measurements included demographics , comorbidity , frailty and nutritional status .
METHODS	Day 21 and day 180 immunogenicity ( seroconversion rate , seroprotection rate , geometric mean titer [ GMT ] fold increase in antibody titer ) using hemagglutination-inhibition and adverse events were measured .
METHODS	Noninferiority and superiority of i.d. compared with i.m. vaccination in immunogenicity were analyzed .
METHODS	The study was registered on ClinicalTrials.gov ; identifier : NCT 01967368 .
RESULTS	At day 21 , noninferiority in immunogenicity of the i.d. vaccination was demonstrated .
RESULTS	The seroconversion rate of the H1N1 strain was significantly higher in the i.d. group .
RESULTS	At day 180 , immunogenicity of both groups fell but the GMT of all strains in i.d. group was higher and the difference was significant for H3N2 strain .
RESULTS	The seroconversion rate and GMT fold increase of H3N2 strain was significantly higher in the i.d. group .
RESULTS	Local adverse events was significantly more in i.d. group , but they were mild and resolved in 72 hours .
CONCLUSIONS	I.d. vaccination is noninferior , and even superior in some parts of immunogenicity assessment , to i.m. vaccination without compromising safety in nursing home older adults .
CONCLUSIONS	I.d. vaccination is a good alternative to i.m. vaccination in this population .

###25078310
BACKGROUND	Calcineurin inhibitors ( CNIs ) reduce short-term kidney transplant failure , but might contribute to transplant failure in the long-term .
BACKGROUND	The role of alemtuzumab ( a potent lymphocyte-depleting antibody ) as an induction treatment followed by an early reduction in CNI and mycophenolate exposure and steroid avoidance , after kidney transplantation is uncertain .
BACKGROUND	We aimed to assess the efficacy and safety of alemtuzumab-based induction treatment compared with basiliximab-based induction treatment in patients receiving kidney transplants .
METHODS	For this randomised trial , we enrolled patients aged 18 years and older who were scheduled to receive a kidney transplant in the next 24 h from 18 transplant centres in the UK .
METHODS	Using minimised randomisation , we randomly assigned patients ( 1:1 ; minimised for age , sex , and immunological risk ) to either alemtuzumab-based induction treatment ( ie , alemtuzumab followed by low-dose tacrolimus and mycophenolate without steroids ) or basiliximab-based induction treatment ( basiliximab followed by standard-dose tacrolimus , mycophenolate , and prednisolone ) .
METHODS	Participants were reviewed at discharge from hospital and at 1 , 3 , 6 , 9 , and 12 months after transplantation .
METHODS	The primary outcome was biopsy-proven acute rejection at 6 months , analysed by intention to treat .
METHODS	The study is registered at ClinicalTrials.gov , number NCT01120028 , and isrctn.org , number ISRCTN88894088 .
RESULTS	Between Oct 4 , 2010 , and Jan 21 , 2013 , we randomly assigned 852 participants to treatment : 426 to alemtuzumab-based treatment and 426 to basiliximab-based treatment .
RESULTS	Overall , individuals allocated to alemtuzumab-based treatment had a 58 % proportional reduction in biopsy-proven acute rejection compared with those allocated to basiliximab-based treatment ( 31 [ 7 % ] patients in the alemtuzumab group vs 68 [ 16 % ] patients in the basiliximab group ; hazard ratio ( HR ) 042 , 95 % CI 028-064 ; log-rank p < 00001 ) .
RESULTS	We detected no between-group difference in treatment effect on transplant failure during the first 6 months ( 16 [ 4 % ] patients vs 13 [ 3 % ] patients ; HR 123 , 059-255 ; p = 058 ) or serious infection ( 135 [ 32 % ] patients vs 136 [ 32 % ] patients ; HR 102 , 080-129 ; p = 088 ) .
RESULTS	During the first 6 months after transplantation , 11 ( 3 % ) patients given alemtuzumab-based treatment and six ( 1 % ) patients given basiliximab-based treatment died ( HR 179 , 95 % CI 066-483 ; p = 025 ) .
CONCLUSIONS	Compared with standard basiliximab-based treatment , alemtuzumab-based induction therapy followed by reduced CNI and mycophenolate exposure and steroid avoidance reduced the risk of biopsy-proven acute rejection in a broad range of patients receiving a kidney transplant .
CONCLUSIONS	Long-term follow-up of this trial will assess whether these effects translate into differences in long-term transplant function and survival .
BACKGROUND	UK National Health Service Blood and Transplant Research and Development Programme , Pfizer , and Novartis UK .

###24585720
BACKGROUND	Initially , unresectable colorectal liver metastases can be resected after response to chemotherapy .
BACKGROUND	While cetuximab has been shown to increase response and resection rates , the survival outcome for this conversion strategy needs further evaluation .
METHODS	Patients with technically unresectable and/or 5 liver metastases were treated with FOLFOX/cetuximab ( arm A ) or FOLFIRI/cetuximab ( arm B ) and evaluated with regard to resectability every 2 months .
METHODS	Tumour response and secondary resection data have been reported previously .
METHODS	A final analysis of overall survival ( OS ) and progression-free survival ( PFS ) was carried out in December 2012 .
RESULTS	Between December 2004 and March 2008 , 56 patients were randomised to arm A , 55 to arm B.
RESULTS	The median OS was 35.7 [ 95 % confidence interval ( CI ) 27.2-44 .2 ] months [ arm A : 35.8 ( 95 % CI 28.1-43 .6 ) , arm B : 29.0 ( 95 % CI 16.0-41 .9 ) months , HR 1.03 ( 95 % CI 0.66-1 .61 ) , P = 0.9 ] .
RESULTS	The median PFS was 10.8 ( 95 % CI 9.3-12 .2 ) months [ arm A : 11.2 ( 95 % CI 7.2-15 .3 ) , arm B : 10.5 ( 95 % CI 8.9-12 .2 ) months , HR 1.18 ( 95 % CI 0.79-1 .74 ) , P = 0.4 ] .
RESULTS	Patients who underwent R0 resection ( n = 36 ) achieved a better median OS [ 53.9 ( 95 % CI 35.9-71 .9 ) months ] than those who did not [ 21.9 ( 95 % CI 17.1-26 .7 ) months , P < 0.001 ] .
RESULTS	The median disease-free survival for R0 resected patients was 9.9 ( 95 % CI 5.8-14 .0 ) months , and the 5-year OS rate was 46.2 % ( 95 % CI 29.5 % to 62.9 % ) .
CONCLUSIONS	This study confirms a favourable long-term survival for patients with initially sub-optimal or unresectable colorectal liver metastases who respond to conversion therapy and undergo secondary resection .
CONCLUSIONS	Both FOLFOX/FOLFIRI plus cetuximab , appear to be appropriate regimens for ` conversion ' treatment in patients with K-RAS codon 12/13/61 wild-type tumours .
CONCLUSIONS	Thus , liver surgery can be considered curative or alternatively as an additional ` line of therapy ' in those patients who are not cured .
BACKGROUND	NCT00153998 , www.clinicaltrials.gov .

###24621174
BACKGROUND	Ankle fractures account for 9 % of all fractures with a quarter of these occurring in adults over 60years .
BACKGROUND	The short term disability and long-term consequences of this injury can be considerable .
BACKGROUND	Current opinion favours open reduction and internal fixation ( ORIF ) over non-operative treatment ( fracture manipulation and the application of a standard moulded cast ) for older people .
BACKGROUND	Both techniques are associated with complications but the limited published research indicates higher complication rates of fracture malunion ( poor position at healing ) with casting .
BACKGROUND	The aim of this study is to compare ORIF with a modification of existing casting techniques , Close Contact Casting ( CCC ) .
BACKGROUND	We propose that CCC may offer an equivalent functional outcome to ORIF and avoid the risks associated with surgery .
METHODS	This study is a pragmatic multi-centre equivalence randomised controlled trial .
METHODS	620 participants will be randomised to receive ORIF or CCC after sustaining an isolated displaced unstable ankle fracture .
METHODS	Participants will be recruited from a minimum of 20 National Health Service ( NHS ) acute hospitals throughout England and Wales .
METHODS	Participants will be aged over 60years and be ambulatory prior to injury .
METHODS	Follow-up will be at six weeks and six months after randomisation .
METHODS	The primary outcome is the Olerud & Molander Ankle Score , a functional patient reported outcome measure , at 6months .
METHODS	Follow-up will also include assessments of mobility , ankle range of movement , health related quality of life and complications .
METHODS	The six-month follow-up will be conducted face-to-face by an assessor blinded to the allocated intervention .
METHODS	A parallel economic evaluation will consider both a health service and a broader societal perspective including the individual and their family .
METHODS	In order to explore patient experience of their treatment and recovery , a purposive sample of 40 patients will also be interviewed using a semi-structured interview schedule between 6-10weeks post treatment .
CONCLUSIONS	This multicentre study was open to recruitment July 2010 and recruitment is due to be completed in December 2013 .
BACKGROUND	Current Controlled Trials ISRCTN04180738 .

###25693988
BACKGROUND	Dyad practice may be as effective as individual practice during clinical skills training , improve students ' confidence , and reduce costs of training .
BACKGROUND	However , there is little evidence that dyad training is non-inferior to single-student practice in terms of skills transfer .
OBJECTIVE	This study was conducted to compare the effectiveness of simulation-based ultrasound training in pairs ( dyad practice ) with that of training alone ( single-student practice ) on skills transfer .
METHODS	In a non-inferiority trial , 30 ultrasound novices were randomised to dyad ( n = 16 ) or single-student ( n = 14 ) practice .
METHODS	All participants completed a 2-hour training programme on a transvaginal ultrasound simulator .
METHODS	Participants in the dyad group practised together and took turns as the active practitioner , whereas participants in the single group practised alone .
METHODS	Performance improvements were evaluated through pre - , post - and transfer tests .
METHODS	The transfer test involved the assessment of a transvaginal ultrasound scan by one of two clinicians using the Objective Structured Assessment of Ultrasound Skills ( OSAUS ) .
RESULTS	Thirty participants completed the simulation-based training and 24 of these completed the transfer test .
RESULTS	Dyad training was found to be non-inferior to single-student training : transfer test OSAUS scores were significantly higher than the pre-specified non-inferiority margin ( delta score 7.8 % , 95 % confidence interval -3.8 -19.6 % ; p = 0.04 ) .
RESULTS	More dyad ( 71.4 % ) than single ( 30.0 % ) trainees achieved OSAUS scores above a pre-established pass/fail level in the transfer test ( p = 0.05 ) .
RESULTS	There were significant differences in performance scores before and after training in both groups ( pre - versus post-test , p < 0.01 ) with large effect sizes ( Cohen 's d = 3.85 ) and no significant interactions between training type and performance ( p = 0.59 ) .
RESULTS	The dyad group demonstrated higher training efficiency in terms of simulator score per number of attempts compared with the single-student group ( p = 0.03 ) .
CONCLUSIONS	Dyad practice improves the efficiency of simulation-based training and is non-inferior to individual practice in terms of skills transfer .

###24913256
BACKGROUND	Google Street View provides a valuable and efficient alternative to observe the physical environment compared to on-site fieldwork .
BACKGROUND	However , studies on the use , reliability and validity of Google Street View in a cycling-to-school context are lacking .
BACKGROUND	We aimed to study the intra - , inter-rater reliability and criterion validity of EGA-Cycling ( Environmental Google Street View Based Audit - Cycling to school ) , a newly developed audit using Google Street View to assess the physical environment along cycling routes to school .
METHODS	Parents ( n = 52 ) of 11-to-12-year old Flemish children , who mostly cycled to school , completed a questionnaire and identified their child 's cycling route to school on a street map .
METHODS	Fifty cycling routes of 11-to-12-year olds were identified and physical environmental characteristics along the identified routes were rated with EGA-Cycling ( 5 subscales ; 37 items ) , based on Google Street View .
METHODS	To assess reliability , two researchers performed the audit .
METHODS	Criterion validity of the audit was examined by comparing the ratings based on Google Street View with ratings through on-site assessments .
RESULTS	Intra-rater reliability was high ( kappa range 0.47-1 .00 ) .
RESULTS	Large variations in the inter-rater reliability ( kappa range -0.03 -1.00 ) and criterion validity scores ( kappa range -0.06 -1.00 ) were reported , with acceptable inter-rater reliability values for 43 % of all items and acceptable criterion validity for 54 % of all items .
CONCLUSIONS	EGA-Cycling can be used to assess physical environmental characteristics along cycling routes to school .
CONCLUSIONS	However , to assess the micro-environment specifically related to cycling , on-site assessments have to be added .

###25091056
OBJECTIVE	Preoperative nutrition is beneficial for malnourished cancer patients .
OBJECTIVE	Yet , there is little evidence whether or not it should be given to nonmalnourished patients .
OBJECTIVE	The aim of this study was to assess the need to introduce preoperative nutritional support in patients without malnutrition at qualification for surgery .
METHODS	This was a prospective , two-arm , randomized , controlled , open-label study .
METHODS	Patients in interventional group received nutritional supplementation for 14 days before surgery , while control group kept on to their everyday diet .
METHODS	Each patient 's nutritional status was assessed twice -- at qualification ( weight loss in 6 months , laboratory parameters : albumin , total protein , transferrin , and total lymphocyte count ) and 1 day before surgery ( change in body weight and laboratory parameters ) .
METHODS	After surgery , all patients were followed up for 30 days for postoperative complications .
RESULTS	Fifty-four patients in interventional and 48 in control group were analyzed .
RESULTS	In postoperative period , patients in control group suffered from significantly higher ( p < 0.001 ) number of serious complications compared with patients receiving nutritional supplementation .
RESULTS	Moreover , levels of all laboratory parameters declined significantly ( p < 0.001 ) in these patients , while in interventional arm were stable ( albumin and total protein ) or raised ( transferrin and total lymphocyte count ) .
CONCLUSIONS	Preoperative nutritional support should be introduced for nonmalnourished patients as it helps to maintain proper nutritional status and reduce number and severity of postoperative complications compared with patients without such support .

###25764777
BACKGROUND	Juvenile Cerebral Palsy -- is caused by damage of the motor control centers of the developing brain ( cerebral refers to the cerebrum , which is the affected area of the brain , although the disorder probably involves connections between the cortex and other parts of the brain and palsy refers to disorder of movement ) .
BACKGROUND	The clinical symptoms of juvenile cerebral palsy are very diversified and include gross and fine motor-coordination disorders , manual ability , locomotion , perception and response , speech , psychomotor retardation , emotional disorders .
BACKGROUND	The primary therapeutic problem in children with cerebral palsy is learning to move in a lower position and learning to walk .
BACKGROUND	The aim of this research is evaluation the action of the botulinum toxin on gait pattern of children with cerebral palsy .
BACKGROUND	Application of a comprehensive BTS analysis of gait will get accurate , consistent EBM ( Evidence Base Medicine ) results .
METHODS	The children with pyramidal syndrome of juvenile cerebral palsy have been included in the examinations .
METHODS	The children have been divided into 2 random groups : group I -- children treated with standard therapy a neurodevelopmental rehabilitation and classic kinesiotherapy , group II -- hildren treated with standard therapy -- eurodevelopmental rehabilitation , classic kinesiotherapy and a botulinum toxin .
METHODS	The children were examined three times : before the therapy , after 6 weeks of treatment and after 3 months of treatment .
METHODS	In the research BTS comprehensive motion analysis system have been used where influence of toxin botulin on walk stereotype of children was assessed .
RESULTS	The treatment connected with standard rehabilitation and using botulinum toxin brings quicker walk improvement .
RESULTS	Comparing the above treatment methods of influence on the walk stereotype of children with juvenile cerebral palsy , we can confirm , that standard treatment brings regular improvement , still , it requires longer period of time , often even 3 months .
RESULTS	Using botulinum toxin brings quicker walk improvement , after 6 weeks only , which is a clear , but short-term result .
CONCLUSIONS	Botulinum toxin has a positive effect on gait parameters in children , especially until 3 months , after this time parameters are not better .
CONCLUSIONS	Concomitant treatment with standard therapy and botulinum toxin should be used becouse it is possitive treatment for locomotion of children with cerebral palsy .

###24508292
BACKGROUND	Appearance-based education shows promise in promoting sunscreen use although resource-intensive methods used in prior studies preclude wide dissemination .
BACKGROUND	Appearance-based video education can be made easily accessible .
OBJECTIVE	We sought to compare the effectiveness of appearance-based video education with that of health-based video education in improving sunscreen use and knowledge .
METHODS	In a randomized controlled trial , participants viewed either an appearance-based video on ultraviolet-induced premature aging or a health-based video emphasizing ultraviolet exposure and skin cancer risk .
RESULTS	Fifty high-school students participated in the study , conducted from February through March 2012 .
RESULTS	The health-based group had a nonstatistically significant increase in sunscreen use ( 0.9 1.9 d/wk , P = .096 ) , whereas the appearance-based group demonstrated a statistically significant increase in sunscreen use ( 2.8 2.2 , P < .001 ) .
RESULTS	Between-group comparisons revealed that the appearance-based group applied sunscreen at significantly greater frequencies compared with the health-based group ( 2.21.4 vs 0.2 0.6 , P < .001 ) .
RESULTS	Knowledge scores significantly improved in both study groups .
RESULTS	Thedifference in knowledge scores between the study groups was not significant .
CONCLUSIONS	The study population may not reflect the general population .
CONCLUSIONS	Appearance-based video education appears to be effective in promoting sunscreen use and knowledge in adolescents .

###24897083
BACKGROUND	Oritavancin is a lipoglycopeptide with bactericidal activity against gram-positive bacteria .
BACKGROUND	Its concentration-dependent activity and prolonged half-life allow for single-dose treatment .
METHODS	We conducted a randomized , double-blind trial in which adults with acute bacterial skin and skin-structure infections received either a single intravenous dose of 1200 mg of oritavancin or a regimen of intravenous vancomycin twice daily for 7 to 10 days .
METHODS	Three efficacy end points were tested for noninferiority .
METHODS	The primary composite end point was defined as cessation of spreading or reduction in lesion size , absence of fever , and no need for administration of a rescue antibiotic 48 to 72 hours after administration of oritavancin .
METHODS	Secondary end points were clinical cure 7 to 14 days after the end of treatment , as determined by a study investigator , and a reduction in lesion size of 20 % or more 48 to 72 hours after administration of oritavancin .
RESULTS	The modified intention-to-treat population comprised 475 patients who received oritavancin and 479 patients who received vancomycin .
RESULTS	All three efficacy end points met the prespecified noninferiority margin of 10 percentage points for oritavancin versus vancomycin : primary end point , 82.3 % versus 78.9 % ( 95 % confidence interval [ CI ] for the difference , -1.6 to 8.4 percentage points ) ; investigator-assessed clinical cure , 79.6 % versus 80.0 % ( 95 % CI for the difference , -5.5 to 4.7 percentage points ) ; and proportion of patients with a reduction in lesion area of 20 % or more , 86.9 % versus 82.9 % ( 95 % CI for the difference , -0.5 to 8.6 percentage points ) .
RESULTS	Efficacy outcomes measured according to type of pathogen , including methicillin-resistant Staphylococcus aureus , were similar in the two treatment groups .
RESULTS	The overall frequency of adverse events was also similar , although nausea was more common among those treated with oritavancin .
CONCLUSIONS	A single dose of oritavancin was noninferior to twice-daily vancomycin administered for 7 to 10 days for the treatment of acute bacterial skin and skin-structure infections caused by gram-positive pathogens .
CONCLUSIONS	( Funded by the Medicines Company ; SOLO I ClinicalTrials.gov number , NCT01252719 . )

###24761786
OBJECTIVE	Many interventions targeting college student drinking have focused on negative health effects of drinking heavily ; however , some research suggests that social factors may have a stronger influence on the drinking behaviour of young people .
OBJECTIVE	Moreover , few studies have examined message framing effects in the context of alcohol consumption .
OBJECTIVE	This study investigated the effects of social and health consequence framing on college students ' intentions to engage in heavy drinking .
METHODS	This study used a 2 2 experimental design with an appended control condition .
METHODS	One hundred and twenty-four college students ( 74 women ; M ( age ) = 18.9 ) participated in this study for course credit .
METHODS	Participants read vignettes that were ostensibly written by a recent graduate from the university , who described an episode of drinking in which he or she experienced either social or health consequences .
METHODS	These consequences were framed as either a gain ( i.e. , positive consequences of not drinking heavily ) or a loss ( i.e. , negative consequences of drinking heavily ) .
METHODS	After reading the vignette , participants completed a measure of heavy drinking intentions .
RESULTS	Regression analyses revealed that social consequences were associated with lower heavy drinking intentions when framed as a loss and that health consequences were associated with lower heavy drinking intentions when framed as a gain .
RESULTS	These effects were stronger among those who reported higher ( vs. lower ) levels of previous drinking .
CONCLUSIONS	Results suggest that interventions that focus on the negative health effects of heavy drinking may be improved by instead emphasizing the negative social consequences of drinking heavily and the positive health consequences of avoiding this behaviour .
CONCLUSIONS	Statement of contribution What is already known on this subject ?
CONCLUSIONS	Previous studies have shown that gain frames are more effective than loss frames when highlighting the health consequences of health risk behaviours , such as heavy drinking .
CONCLUSIONS	The heavy drinking behaviour of young people is influenced by social factors ( e.g. , perceived social consequences ) .
CONCLUSIONS	However , little is known about framing effects for social consequences of heavy drinking .
CONCLUSIONS	What does this study add ?
CONCLUSIONS	This study builds on previous research by demonstrating that a loss frame is more effective than a gain frame when highlighting the social consequences of health risk behaviour .
CONCLUSIONS	Framing effects are strongest for those with more previous drinking experience .

###24239295
OBJECTIVE	Lactobacilli have been found in the neovagina of very low numbers of transsexual women .
OBJECTIVE	We undertook this study to determine whether an orally administered preparation of four lactobacilli strains exerts some measurable effect on the neovaginal microflora of female transsexuals .
METHODS	60 male to female transsexual women with penile linked neovagina were randomised into two groups .
METHODS	Women in the intervention group ( n = 33 ) received oral probiotic capsules and women in the control group ( n = 27 ) placebo in for 7 days .
METHODS	Swabs of the neovagina were taken before and after the therapy .
RESULTS	Comparing the first and second swabs , we observed a significant improvement of the Nugent score in the intervention group 16 ( 48.5 % ) vs. low improvement in control group 4 ( 14.8 % ) ( p < 0.006 ) .
RESULTS	The neovaginal microflora was significantly enriched with lactobacilli after oral supplementation compared to placebo .
RESULTS	In the intervention group , an increase by 10,000600 colony forming units ( CFU ) of presumptive lactobacilli was observed , compared with an increase by 1600100CFU in the control group ( p < 0.0001 ) .
RESULTS	When measured by real-time PCR ( c/ml ) , lactobacilli increased by 1400100c/ml in the intervention group and 300100c/ml in the control group ( p < 0.0001 ) .
CONCLUSIONS	There was an improvement of vaginal lactobacilli microflora after of oral supplementation with lactobacilli strains in transsexual women .

###24256551
BACKGROUND	There is no single model available to predict the long term survival for patients starting renal replacement therapy ( RRT ) .
BACKGROUND	The available models either predict survival on dialysis until transplantation , survival on the transplant waiting list , or survival after transplantation .
BACKGROUND	The aim of this study was to develop a model that includes dialysis survival and survival after an eventual transplantation .
METHODS	From the Dutch renal replacement registry , patients of 16 years of age or older were included if they started RRT between 1995 and 2005 , still underwent RRT at baseline ( 90 days after the start of RRT ) and were not registered at a non-renal organ transplant waiting list ( N = 13868 ) .
METHODS	A prediction model of 10-year patient survival after baseline was developed through multivariate Cox regression analysis , in one half of the research group .
METHODS	Age at start , sex , primary renal disease ( PRD ) and therapy at baseline were included as possible predictors .
METHODS	A sensitivity analysis has been performed to determine whether listing on the transplant waiting list should be added .
METHODS	The predictive performance of the model was internally validated .
METHODS	Calibration and discrimination were computed in the other half of the research group .
METHODS	Another sensitivity analysis was to assess whether the outcomes differed if the model was developed and tested in two geographical regions , which were less similar than the original development and validation group .
METHODS	No external validation has been performed .
RESULTS	Survival probabilities were influenced by age , sex , PRD and therapy at baseline ( p < 0.001 ) .
RESULTS	The calibration and discrimination both showed very reasonable results for the prediction model ( C-index = 0.720 and calibration slope for the prognostic index = 1.025 , for the 10 year survival ) .
RESULTS	Adding registration on the waiting list for renal transplantation as a predictor did not improve the discriminative power of the model and was therefore not included in the model .
CONCLUSIONS	With the presented prediction model , it is possible to give a reasonably accurate estimation on the survival chances of patients who start with RRT , using a limited set of easily available data .

###24637126
BACKGROUND	The ADAGIO study included a large cohort of patients with early PD ( baseline total-UPDRS = 20 ) who were initially randomized to rasagiline and placebo , thereby allowing analyses of symptomatic efficacy .
METHODS	Post-hoc analyses comparing the efficacy of rasagiline 1mg/day ( n = 288 ) versus placebo ( n = 588 ) on key symptoms at 36 weeks , and on total-UPDRS scores over 72 weeks ( completer population : rasagiline 1mg/day n = 221 , placebo n = 392 ) were performed .
RESULTS	Treatment with rasagiline resulted in significantly better tremor , bradykinesia , rigidity and postural-instability-gait-difficulty scores at week 36 versus placebo .
RESULTS	Whereas the placebo group experienced progressive deterioration from baseline ( 2.6 UPDRS points at week 36 ) , patients in the rasagiline group were maintained at baseline values at week 60 ( UPDRS-change of 0.3 points ) .
RESULTS	At week 72 , patients who had received continuous monotherapy with rasagiline experienced a worsening of only 1.6 points .
CONCLUSIONS	Treatment with rasagiline maintained motor function to baseline values for at least a year with significant benefits observed in all key PD motor symptoms .

###24916996
BACKGROUND	In medicine , research misconduct is historically associated with laboratory or pharmaceutical research , but the vulnerability of epidemiological surveys should be recognized .
BACKGROUND	As these surveys underpin health policy and allocation of limited resources , misreporting can have far-reaching implications .
BACKGROUND	We report how fraud in a nationwide headache survey occurred and how it was discovered and rectified before it could cause harm .
METHODS	The context was a door-to-door survey to estimate the prevalence and burden of headache disorders in Pakistan .
METHODS	Data were collected from all four provinces of Pakistan by non-medical interviewers and collated centrally .
METHODS	Measures to ensure data integrity were preventative , detective and corrective .
METHODS	We carefully selected and trained the interviewers , set rules of conduct and gave specific warnings regarding the consequences of falsification .
METHODS	We employed two-fold fraud detection methods : comparative data analysis , and face-to-face re-contact with randomly selected participants .
METHODS	When fabrication was detected , data shown to be unreliable were replaced by repeating the survey in new samples according to the original protocol .
RESULTS	Comparative analysis of datasets from the regions revealed unfeasible prevalences and gender ratios in one ( Multan ) .
RESULTS	Data fabrication was suspected .
RESULTS	During a surprise-visit to Multan , of a random sample of addresses selected for verification , all but one had been falsely reported .
RESULTS	The data ( from 840 cases ) were discarded , and the survey repeated with new interviewers .
RESULTS	The new sample of 800 cases was demographically and diagnostically consistent with other regions .
CONCLUSIONS	Fraud in community-based surveys is seldom reported , but no less likely to occur than in other fields of medical research .
CONCLUSIONS	Measures should be put in place to prevent , detect and , where necessary , correct it .
CONCLUSIONS	In this instance , had the data from Multan been pooled with those from other regions before analysis , a damaging fraud might have escaped notice .

###25879419
BACKGROUND	Access to effective smoking cessation programs is crucial to reducing smoking-related morbidity and mortality .
BACKGROUND	Several studies have shown promising results for the application of Acceptance and Commitment Therapy ( ACT ) in managing psychological or behavioral health problems .
BACKGROUND	However , to date , only one study has examined the feasibility of a telephone-based ACT for smoking cessation and it was conducted among a Western population , in the United States .
BACKGROUND	This study reports a protocol for a randomized controlled trial ( RCT ) examining the feasibility and potential efficacy of an individual , telephone-delivered ACT for smoking cessation in primary healthcare settings among a Chinese population .
METHODS	A randomized , two-group design was chosen , with assessment at baseline ( before intervention ) and via telephone follow-ups at three and six months .
METHODS	Subjects will be proactively recruited from primary healthcare centers .
METHODS	Eligible participants will be randomized to either the intervention ( ACT ) or control group following the baseline assessment .
METHODS	Both groups will receive self-help materials on smoking cessation .
METHODS	Those in the ACT group will undergo an initial face-to-face session and two telephone ACT sessions at one week and one month following the first session , to be delivered by a counselor based on the treatment protocol .
METHODS	All of the participants will be contacted by telephone for follow-up assessments at three and six months .
METHODS	Treatment fidelity will be assessed by reviewing around one-fifth of audio-recorded telephone calls .
CONCLUSIONS	To the best of our knowledge , this protocol describes the first RCT of a telephone-based ACT for smoking cessation .
CONCLUSIONS	It is also the first RCT of ACT for smoking cessation on a Chinese population .
CONCLUSIONS	The study will provide us with information about the feasibility of a telephone-delivered ACT within a Chinese sample .
CONCLUSIONS	If effective , this trial will support the development of ACT treatment protocols that could be made available for use by a greater range of clinicians , and offer an evidence base to support alternative treatments for smoking cessation .
BACKGROUND	ClinicalTrials.gov ID NCT01652508 .
BACKGROUND	Registered on 26 ( th ) July 2012 .

###24839883
OBJECTIVE	In this phase 3 extension study , the long-term maintenance of efficacy of lisdexamfetamine dimesylate ( LDX ) in children and adolescents with attention-deficit/hyperactivity disorder ( ADHD ) was evaluated using a randomized-withdrawal study design .
METHODS	European and US patients ( 6-17 years ; N = 276 ) with ADHD were entered into a 26-week open-label trial of LDX treatment .
METHODS	Those who completed the open-label period ( n = 157 ) were randomized 1:1 to their optimized dose of LDX ( 30 , 50 , or 70 mg per day ) or placebo for a 6-week randomized-withdrawal period ( RWP ) .
METHODS	The primary efficacy measure was the proportion of patients meeting treatment failure criteria ( 50 % increase in ADHD Rating Scale IV total score and 2-point increase in Clinical Global Impressions-Severity of Illness [ CGI-S ] score , compared with RWP start point ) .
METHODS	Safety and tolerability were also evaluated .
RESULTS	During the RWP ( LDX , n = 78 ; placebo , n = 79 ) , significantly fewer patients receiving LDX met treatment failure criteria ( 15.8 % ) compared with those receiving placebo ( 67.5 % ; difference = -51.7 % ; 95 % confidence interval = -65.0 , -38.5 ; p < .001 ) .
RESULTS	Most treatment failures occurred at or before the week 2 visit after randomization .
RESULTS	Treatment-emergent adverse events were reported in 39.7 % and 25.3 % of patients receiving LDX and placebo , respectively , during the RWP .
CONCLUSIONS	These data demonstrate the maintenance of efficacy of LDX during long-term treatment in children and adolescents with ADHD .
CONCLUSIONS	The rapid return of symptoms on LDX withdrawal demonstrates the need for continuing treatment .
CONCLUSIONS	The safety profile of LDX was consistent with that of other stimulants .
CONCLUSIONS	Clinical trial registration information-Double-Blind , Placebo-Controlled , Randomized Withdrawal , Extension , Safety and Efficacy Study of LDX in Children and Adolescents Aged 6-17 ; http://clinicaltrials.gov; NCT00784654 .

###24399100
OBJECTIVE	To compare the utilization of conventional treatments and utilization of complementary and alternative medicine in preschoolers with autism spectrum disorders ( ASD ) and other developmental disabilities ( DD ) .
METHODS	Participants were 578 children who were part of an ongoing population-based , case-control study of 2 - to 5-year olds with ASD , DD , and the general population .
METHODS	Parents completed an interview on past and current services .
RESULTS	Four hundred fifty-three children with ASD and 125 DD children were included .
RESULTS	ASD families received more hours of conventional services compared with DD families ( 17.8 vs 11 ; p < .001 ) .
RESULTS	The use of psychotropic medications was low in both groups ( approximately 3 % ) .
RESULTS	Overall , complementary and alternative medicine ( CAM ) use was not significantly different in ASD ( 39 % ) versus DD ( 30 % ) .
RESULTS	Hispanic families in both groups used CAM less often than non-Hispanic families .
RESULTS	Variables such as level of function , immunization status , and the presence of an identified neurogenetic disorder were not predictive of CAM use .
RESULTS	A higher level of parental education was associated with an increased CAM use in ASD and DD .
RESULTS	Families who used > 20 hours per week of conventional services were more likely to use CAM , including potentially unsafe or disproven CAM .
RESULTS	Underimmunized children were marginally more likely to use CAM but not more likely to have received potentially unsafe or disproven CAM .
CONCLUSIONS	Use of CAM is common in families of young children with neurodevelopmental disorders , and it is predicted by higher parental education and non-Hispanic ethnicity but not developmental characteristics .
CONCLUSIONS	Further research should address how health care providers can support families in making decisions about CAM use .

###24439830
BACKGROUND	There is no established psychometric instrument dedicated to the measurement of severity in psychotic depression ( PD ) .
BACKGROUND	The aim of this study was to investigate whether a new composite rating scale , the Psychotic Depression Assessment Scale ( PDAS ) , covering both the psychotic and the depressive domains of PD , could detect differences in effect between two psychopharmacological treatment regimens .
METHODS	We reanalyzed the data from the Study of Pharmacotherapy of Psychotic Depression ( STOP-PD ) , which compared the effect of Olanzapine + Sertraline ( n = 129 ) versus Olanzapine + Placebo ( n = 130 ) .
METHODS	The response to the two regimens was compared using both a mixed effects model and effect size statistics on the total scores of three rating scales : the 17-item Hamilton Depression Rating Scale ( HAM-D17 ) , its 6-item melancholia subscale ( HAM-D6 ) , and the 11-item PDAS consisting of the HAM-D6 plus five items from the Brief Psychiatric Rating Scale covering psychotic symptoms .
RESULTS	According to both statistical approaches , the PDAS , the HAM-D17 and the HAM-D6 were all able to detect significant differences in treatment effect between Olanzapine + Sertraline and Olanzapine + Placebo ( Olanzapine + Sertraline being superior ) .
RESULTS	Notably , 45 % of the trial participants were at least `` probable psychotic '' at their last assessment in the trial .
CONCLUSIONS	The STOP-PD was not designed specifically to answer the research questions of the present study .
CONCLUSIONS	The Psychotic Depression Assessment Scale ( PDAS ) is a sensitive measure of treatment response in PD .
CONCLUSIONS	The fact that 45 % of the patients still experienced psychotic symptoms at their last trial assessment emphasizes the need to include items pertaining to psychotic symptoms in rating scales for PD .

###24767623
BACKGROUND	This study examined the effects of three consecutive days of attentional training on the salivary alpha amylase ( sAA ) , cortisol , and mood response to the Trier Social Stress Test ( TSST ) .
BACKGROUND	The training was designed to elicit faster disengagement of attention away from threatening facial expressions and faster shifts of attention toward positive ones .
METHODS	Fifty-six healthy participants between the ages of 18 and 30 participated in a double-blind , within-subject experiment .
METHODS	Participants were randomly assigned to one of three attentional training conditions - supraliminal training : pictures shown with full conscious awareness , masked training : stimuli presented with limited conscious awareness , or control training : both supraliminal and masked pictures shown but no shifting of attention required .
METHODS	Following training , participants underwent the TSST .
METHODS	Self-reported mood and saliva samples were collected for the determination of emotional reactivity , cortisol , and sAA in response to stress post-training .
RESULTS	Unexpectedly , participants in both attentional training groups exhibited a higher salivary cortisol response to the TSST relative to participants who underwent the control training , F ( 4 , 86 ) = 4.07 , p = .005 , p ( 2 ) = .16 .
RESULTS	Supraliminal training was also associated with enhanced sAA reactivity , F ( 2 , 44 ) = 13.90 , p = .000 , p ( 2 ) = .38 , and a more hostile mood response ( p = .021 ) , to the TSST .
RESULTS	Interestingly , the effect of attention training on the cortisol response to stress was more robust in those with high attentional control than those with low attentional control ( = -0.134 ; t = -2.24 , p = .03 ) .
CONCLUSIONS	This is among the first experimental manipulations to demonstrate that attentional training can elicit a paradoxical increase in three different markers of stress reactivity .
CONCLUSIONS	These findings suggest that attentional training , in certain individuals , can have iatrogenic effects .

###25039961
BACKGROUND	The PACT randomised-controlled trial evaluated a parent-mediated communication-focused treatment for children with autism , intended to reduce symptom severity as measured by a modified Autism Diagnostic Observation Schedule-Generic ( ADOS-G ) algorithm score .
BACKGROUND	The therapy targeted parental behaviour , with no direct interaction between therapist and child .
BACKGROUND	While nonsignificant group differences were found on ADOS-G score , significant group differences were found for both parent and child intermediate outcomes .
BACKGROUND	This study aimed to better understand the mechanism by which the PACT treatment influenced changes in child behaviour though the targeted parent behaviour .
METHODS	Mediation analysis was used to assess the direct and indirect effects of treatment via parent behaviour on child behaviour and via child behaviour on ADOS-G score .
METHODS	Alternative mediation was explored to study whether the treatment effect acted as hypothesised or via another plausible pathway .
METHODS	Mediation models typically assume no unobserved confounding between mediator and outcome and no measurement error in the mediator .
METHODS	We show how to better exploit the information often available within a trial to begin to address these issues , examining scope for instrumental variable and measurement error models .
RESULTS	Estimates of mediation changed substantially when account was taken of the confounder effects of the baseline value of the mediator and of measurement error .
RESULTS	Our best estimates that accounted for both suggested that the treatment effect on the ADOS-G score was very substantially mediated by parent synchrony and child initiations .
CONCLUSIONS	The results highlighted the value of repeated measurement of mediators during trials .
CONCLUSIONS	The theoretical model underlying the PACT treatment was supported .
CONCLUSIONS	However , the substantial fall-off in treatment effect highlighted both the need for additional data and for additional target behaviours for therapy .

###24330484
BACKGROUND	Medical textbooks often list Legionnaires ' disease as a differential diagnosis of the syndrome of inappropriate secretion of anti-diuretic hormone ( ADH ) ( SIADH ) , but evidence supporting this association is largely lacking .
BACKGROUND	We tested the hypothesis whether hyponatremia in patients with Legionnaires ' disease would be caused by increased CT-ProVasopressin .
METHODS	We measured CT-ProVasopressin and sodium levels in a prospective cohort of 873 pneumonia patients from a previous multicentre study with 27 patients having positive antigen tests for Legionella pneumophila .
RESULTS	Patients with Legionnaires ' disease more frequently had low sodium levels ( Na < 130mmol/L ) ( 44.4 % vs 8.2 % , p < 0.01 ) , but similar mean CT-ProVasopressin levels ( pmol/l ) ( 39.4 [ 7 ] vs 51.2 [ 2.7 ] , p = 0.43 ) as compared to patients with pneumonia of other etiologies .
RESULTS	In patients with Legionnaires ' disease , CT-ProVasopressin levels showed a positive correlation with sodium ( r = 0.42 , p < 0.05 ) .
RESULTS	Independent of pneumonia etiology , CT-ProVasopressin correlated significantly with the pneumonia severity index ( r = 0.56 , p < 0.05 ) , ICU admission ( adjusted odds ratio per decile , 95 % CI ) ( 1.6 , 1.2 - 2.0 ) , and 30-day-mortality ( 1.8 , 1.3 - 2.4 ) .
CONCLUSIONS	While Legionnaires ' disease was associated with hyponatremia , no concurrent increase in CT-ProVasopressin levels was found , which argues against elevated ADH levels as the causal pathway to hyponatremia .
CONCLUSIONS	Rather , Vasopressin precursors were upregulated as response to stress in severe disease , which seems to overrule the osmoregulatory regulation of ADH .

###24630572
OBJECTIVE	Follicular fluid of mature oocytes is rich in growth factors and cytokines that may exert paracrine and autocrine effects on implantation .
OBJECTIVE	The aim of this study was to investigate if flushing the endometrial cavity with follicular fluid after oocyte retrieval improved pregnancy rates in subfertile women undergoing intracytoplasmic sperm injection ( ICSI ) .
METHODS	One hundred subfertile women undergoing ICSI between April 2012 and September 2012 at the centre for reproductive medicine , Cairo University , Egypt were enrolled in this open label , parallel randomized controlled study .
METHODS	Patients were randomized into two groups at the start of treatment using a computer-generated programme and sealed opaque envelopes : the follicular fluid group ( n = 50 ) and the control group ( n = 50 ) .
METHODS	Inclusion criteria were : age 20-38 years ; basal follicle-stimulating hormone < 10mIU/ml ; body mass index < 35kg/m ( 2 ) ; and ostradiol > 1000pg/ml and < 4000pg/ml on the day of human chorionic gonadotrophin administration .
METHODS	Exclusion criteria were : evidence of endometriosis ; uterine myoma ; hydrosalpinges ; endocrinological disorders ; history of implantation failure in previous in-vitro fertilization/ICSI cycles ; and severe male factor infertility .
RESULTS	Clinical pregnancy and implantation rates were higher in the follicular fluid group compared with the control group [ 354 % ( 17/48 ) vs 319 % ( 15/47 ) ; p = 0718 ] and ( 18.6 % vs 11.3 % ; p = 0.153 ) , respectively .
RESULTS	However , the difference was not statistically significant .
CONCLUSIONS	Flushing the endometrial cavity with follicular fluid after oocyte retrieval neither improved nor adversely affected clinical pregnancy and implantation rates in subfertile women undergoing ICSI .

###25179916
OBJECTIVE	RCT-18 is a novel recombinant fusion protein that targets and neutralizes B-lymphocyte stimulator ( BLyS ) and a proliferation-inducing ligand ( APRIL ) .
OBJECTIVE	This first in-human study investigated the safety , tolerability , pharmacokinetics , immunogenicity , and pharmacodynamics of RCT-18 in patients with rheumatoid arthritis ( RA ) .
METHODS	This was a single-center , randomized , single-blind , placebo-controlled study in 28 RA patients .
METHODS	Eligible patients were randomized 3:1 to receive single subcutaneous doses of RCT-18 ( 1.2 , 6 , 18 , 60 , 180 , 360 , 540mg ) or placebo .
METHODS	A 71-day observation period was scheduled for each patient , during which serial blood sampling for pharmacokinetic , pharmacodynamic , and immunogenicity assessments was performed .
METHODS	Safety was assessed throughout the study .
RESULTS	RCT-18 was well tolerated , although mild infections and skin irritation occurred more frequently in patients receiving this drug .
RESULTS	After single-dose RCT-18 , the maximal serum concentration ( C max ) of total and free RCT-18 was reached within 1-2days , followed by a multi-exponential decline .
RESULTS	Mean elimination half-life for total RCT-18 and free RCT-18 was 5.7-12 .8 days and 3.2-11 .3 days at 6-60mg , and 15.1-17 .5 days and 18.8-36 .8 days with 180-540mg RCT-18 .
RESULTS	The formation and elimination of BLyS-RCT-18 complex were much slower , with a time to C max of 5-29days and the elimination half-life mounting from 13.3 to 32.8 days with dose escalation .
RESULTS	No positive reaction was detected in the immunogenicity assessments .
RESULTS	Substantial IgM reduction was only evidenced with 540mg RCT-18 , while the response profiles of IgM/IgG were distinguishable from placebo after 180 , 360 , or 540mg RCT-18 .
CONCLUSIONS	RCT-18 was safe and well tolerated up to 540-mg single doses .
CONCLUSIONS	The serum exposure of total and free RCT-18 is linearly correlated to the weight-normalized doses of RCT-18 in dose groups receiving 180-540mg RCT-18 .
CONCLUSIONS	The elimination half-life of BLyS-RCT-18 increased with RCT-18 doses , suggesting a shift from target-mediated disposition in 1.2-18mg RCT-18 groups to non-specific clearance in 60-540mg RCT-18 groups .
CONCLUSIONS	Assuming the concentration of BLyS-RCT-18 complex and the IgM/IgG ratio are surrogate biomarkers for clinical effects of RCT-18 , the dose-response relationship suggests 180-540mg are pharmacodynamically effective doses in RCT-18 for RA patients , but the effect profile of 540mg RCT-18 on IgM is similar to that of atacicept at pharmacodynamically effective but clinically ineffective doses .

###24801369
OBJECTIVE	Dairy protein seems to reduce appetite by increasing satiety and delaying the return of hunger and subsequently lowering energy intake compared with fat or carbohydrate .
OBJECTIVE	The aim of this study was to compare the effect of whey with that of casein proteins on satiety in overweight/obese individuals .
METHODS	This was a randomized , parallel-design 12-week-long study .
METHODS	Seventy subjects with a body mass index between 25 and 40kg/m ( 2 ) and aged 18-65 years were randomized into one of three supplement groups : glucose control ( n = 25 ) , casein ( n = 20 ) or whey ( n = 25 ) protein .
METHODS	Before commencing the study , at weeks 6 and 12 of the treatment , a Visual Analogue Scale ( VAS ) was used to measure subjective sensations of appetite before lunch and before dinner .
RESULTS	Rating for VAS ( mm ) at 6 and 12 weeks showed significantly higher satiety in the whey group compared with the casein ( P = 0.017 and P = 0.025 , respectively ) or control ( P = 0.024 and P = 0.032 , respectively ) groups when measured before lunch .
RESULTS	Similarly , at 6 and 12 weeks , the score for fullness was also significantly higher in the whey group compared with both casein ( P = 0.038 and P = 0.022 , respectively ) and control ( P = 0.020 and P = 0.030 , respectively ) groups .
RESULTS	However , these short-term effects on satiety from dairy whey proteins did not have any long-term effects on energy intake or body weight over 12 weeks compared with casein .
CONCLUSIONS	Collectively , whey protein supplementation appears to have a positive and acute postprandial effect on satiety and fullness compared with casein and carbohydrate supplementation in overweight and obese individuals .

###24814479
BACKGROUND	Inhalation of diesel exhaust ( DE ) at moderate concentrations causes increased airway responsiveness in asthmatics and increased airway resistance in both healthy and asthmatic subjects , but the effect of baseline airway responsiveness and anti-oxidant supplementation on this dynamic is unknown .
OBJECTIVE	We aimed to determine if changes in airway responsiveness due to DE are attenuated by thiol anti-oxidant supplementation , particularly in those with underlying airway hyper-responsiveness .
METHODS	Participants took N-acetylcysteine ( 600 mg ) or placebo capsules three times daily for 6 days .
METHODS	On the last of these 6 days , participants were exposed for 2 h to either filtered air ( FA ) or DE ( 300 g/m ( 3 ) of particulate matter smaller than 2.5 microns ) .
METHODS	Twenty-six non-smokers were studied under each of three experimental conditions ( filtered air with placebo , diesel exhaust with placebo , and diesel exhaust with N-acetylcysteine ) using a randomized , double-blind , crossover design , with a 2-week washout between conditions .
METHODS	Methacholine challenge was performed pre-exposure ( baseline airway responsiveness ) and post-exposure ( effect of exposure ) .
RESULTS	Anti-oxidant supplementation reduced baseline airway responsiveness in hyper-responsive individuals by 20 % ( p = 0.001 ) .
RESULTS	In hyper-responsive individuals , airway responsiveness increased 42 % following DE compared with FA ( p = 0.03 ) and this increase was abrogated with anti-oxidant supplementation ( diesel exhaust with N-acetylcysteine vs. filtered air with placebo , p = 0.85 ) .
CONCLUSIONS	Anti-oxidant ( N-acetylcysteine ) supplementation protects against increased airway responsiveness associated with DE inhalation and reduces need for supplement bronchodilators in those with baseline airway hyper-responsiveness .
CONCLUSIONS	Individuals with variants in genes of oxidative stress metabolism when exposed to DE are protected from increases in airway responsiveness if taking anti-oxidant supplementation .

###24256334
OBJECTIVE	To test the effectiveness of thymus honey as a complementary intervention for decreasing the salivary gland damage due to Radioiodine ( ( 131 ) I ) therapy .
BACKGROUND	Radioiodine is the treatment of choice in people diagnosed with thyroid cancer following total thyroidectomy .
BACKGROUND	Although its value has been acknowledged in eradicating remnant thyroid tissue and treating residual disease in patients with visible , inoperable , iodine-avid metastases , it has been associated with various salivary gland side effects .
METHODS	This is a randomized controlled trial with a 2 3 mixed between-within subjects design .
METHODS	In total , 120 participants of postsurgical differentiated thyroid cancer , who will be referred to this centre for ( 131 ) I therapy to ablate the remnant thyroid tissue or to treat metastatic tumour , will be prospectively studied under varying regimens of lemon candy ( standard treatment ) and thymus honey mouthwashes ( experimental intervention ) .
METHODS	Patients will be randomized in four equally numbered groups based on the assumptions and hypothesis of the study .
METHODS	The recruiting process will be informed by predefined inclusion and exclusion criteria .
METHODS	Mixed statistical modelling will be adopted taking into consideration between and within subjects ' effects and repeated measures .
CONCLUSIONS	The recommended intervention protocol is expected to improve the comprehensive management of salivary gland-related side effects induced by the radioiodine treatment in people diagnosed with thyroid cancer .
CONCLUSIONS	Through the methodological approach chosen , the ideal intervention protocol in terms of the time to initiate the intervention and the frequency of the intervention to acquire optimal results in minimizing salivary glands damage will be tested .

###24800718
OBJECTIVE	This study examined the immediate effects of noxious and innocuous thermal stimulation intervention on corticomotor excitability for the paretic arm in patients with stroke .
METHODS	Sixteen patients with stroke for more than 3 mos were randomly assigned into the experimental and control groups .
METHODS	All participants received the thermal stimulation protocol on the affected arm for 30 mins .
METHODS	The experimental group received noxious heat ( 46C-47C ) and cold ( 7C-8C ) stimuli , and the control group received innocuous heat ( 40C-41C ) and cold ( 20C-21C ) stimuli .
METHODS	Corticomotor excitability was assessed to measure the motor threshold , size of cortical motor output map , and mean motor evoked potentials for the abductor pollicis brevis by focal transcranial magnetic stimulation before and after 30 mins of thermal stimulation intervention program .
RESULTS	The findings of transcranial magnetic stimulation revealed a significant increase in map size of the affected hemisphere and mean motor evoked potentials in the experimental group .
RESULTS	Moreover , significant differences in the change values of map size ( 7.0 [ 7.9 ] for the experimental group vs. -1.7 [ 2.9 ] for the control group , P = 0.03 ) and mean ( SD ) motor evoked potentials ( 0.4 [ 8.9 ] mV for the experimental group vs. -0.1 [ 0.1 ] mV for the control group , P = 0.03 ) were found .
CONCLUSIONS	The preliminary results suggest that the noxious 30 mins of thermal stimulation intervention induced neurophysiologic changes in the motor cortex of the lesioned hemisphere .

###25573027
OBJECTIVE	To evaluate the effectiveness of neuromuscular electrical stimulation ( NMES ) treatment in patients with oropharyngeal dysphagia secondary to acquired brain injury .
METHODS	Twenty patients with neurological oropharyngeal dysphagia ( 14 stroke and six severe traumatic brain injury ) were enrolled in a prospective randomized study , with patients and assessors blinded ( to group allocation ) : 10 patients underwent NMES and conventional swallowing therapy and 10 patients underwent sham electrical stimulation ( SES ) and conventional swallowing therapy .
METHODS	Both groups completed 20 sessions .
METHODS	At baseline , at the end of treatment ( 1month ) and at 3-month follow-up , clinical , videofluoroscopic and esophageal manometric analyses were done .
METHODS	Feeding swallowing capacity was evaluated using the functional oral intake scale ( FOIS ) .
RESULTS	Mean FOIS score before treatment was 1.9 for the NMES group and 2.1 for the SES group .
RESULTS	After treatment , the NMES group increased by 2.6 points ( 4.5 points ) compared with only 1 point ( 3.1 points ) for the SES group ( P = 0.005 ) .
RESULTS	At 3months of follow-up , mean scores were 5.3 and 4.6 respectively ; thus , both groups improved similarly .
RESULTS	At that time point ( 3months ) , tracheal aspiration persisted in six patients in each group .
RESULTS	However , a significant improvement in relation to the bolus viscosity at which aspiration appeared was found in the NMES group versus the SES group ( P = 0.015 ) .
RESULTS	Also , a significant increase ( P = 0.04 ) in pharyngeal amplitude contraction was observed at the end of treatment ( 1month ) in the NMES group compared with the SES group .
CONCLUSIONS	Neuromuscular electrical stimulation significantly accelerated swallowing function improvement in patients with oropharyngeal dysphagia secondary to acquired brain injury .

###25380241
OBJECTIVE	An earlier randomized controlled trial ( RCT ) study showed that bee venom acupuncture ( BVA ) in combination with physiotherapy can be more effective in functional improvement and pain reduction in patients with adhesive capsulitis ( AC ) .
OBJECTIVE	The objective of the current study was to examine the long-term effect of BVA in combination with physiotherapy on AC of the shoulder .
METHODS	Retrospective 1-year follow-up analysis of a previous RCT using a telephone interview method .
METHODS	Outpatient joint center at the Gang Dong Kyung Hee University Hospital of Seoul , Republic of Korea .
METHODS	A total of 192 patients had been enrolled in the previous study , and 124 of these were excluded from the current study .
METHODS	Sixty-eight patients who had been treated with combined BVA and physiotherapy for AC of the shoulder for 2 months were interviewed at approximately 1 year after treatment by telephone .
METHODS	Sixty of 68 patients were included in the follow-up analysis .
METHODS	Twenty received BV 1 treatment ( 1:10,000 concentration BVA plus physiotherapy ) , 22 received BV 2 treatment ( 1:30,000 concentration BVA plus physiotherapy ) , and 18 received control treatment ( normal saline injection plus physiotherapy ) .
METHODS	The primary outcome measure was Shoulder Pain And Disability Index ( SPADI ) score .
METHODS	Secondary outcome measure was score on verbal rating scale for pain and patient satisfaction .
RESULTS	Baseline characteristics of the groups did not significantly differ .
RESULTS	SPADI scores at 1 year significantly differed between the BV 1 group and the control group ( p = 0.043 ) .
RESULTS	No significant differences were found in pain verbal rating scores after 1 year .
RESULTS	Treatment satisfaction with therapy was also assessed , and the BV 1 and BV 2 groups showed significantly greater satisfaction compared with the control group .
CONCLUSIONS	BVA combined with physiotherapy remains clinically effective 1 year after treatment and may help improve long-term quality of life in patients with AC of the shoulder .

###24475144
BACKGROUND	Synaptic loss is a major hallmark of Alzheimer 's disease ( AD ) .
BACKGROUND	Disturbed organisation of large-scale functional brain networks in AD might reflect synaptic loss and disrupted neuronal communication .
BACKGROUND	The medical food Souvenaid , containing the specific nutrient combination Fortasyn Connect , is designed to enhance synapse formation and function and has been shown to improve memory performance in patients with mild AD in two randomised controlled trials .
OBJECTIVE	To explore the effect of Souvenaid compared to control product on brain activity-based networks , as a derivative of underlying synaptic function , in patients with mild AD .
METHODS	A 24-week randomised , controlled , double-blind , parallel-group , multi-country study .
METHODS	179 drug-nave mild AD patients who participated in the Souvenir II study .
METHODS	Patients were randomised 11 to receive Souvenaid or an iso-caloric control product once daily for 24 weeks .
RESULTS	In a secondary analysis of the Souvenir II study , electroencephalography ( EEG ) brain networks were constructed and graph theory was used to quantify complex brain structure .
RESULTS	Local brain network connectivity ( normalised clustering coefficient gamma ) and global network integration ( normalised characteristic path length lambda ) were compared between study groups , and related to memory performance .
RESULTS	THE NETWORK MEASURES IN THE BETA BAND WERE SIGNIFICANTLY DIFFERENT BETWEEN GROUPS : they decreased in the control group , but remained relatively unchanged in the active group .
RESULTS	No consistent relationship was found between these network measures and memory performance .
CONCLUSIONS	The current results suggest that Souvenaid preserves the organisation of brain networks in patients with mild AD within 24 weeks , hypothetically counteracting the progressive network disruption over time in AD .
CONCLUSIONS	The results strengthen the hypothesis that Souvenaid affects synaptic integrity and function .
CONCLUSIONS	Secondly , we conclude that advanced EEG analysis , using the mathematical framework of graph theory , is useful and feasible for assessing the effects of interventions .
BACKGROUND	Dutch Trial Register NTR1975 .

###24680330
OBJECTIVE	To investigate the therapeutic effect of topical corticosteroids injection and systemic application in the treatment of typing idiopathic sudden sensorineural hearing loss ( ISSNHL ) .
METHODS	Total of 438 patients with ISSNHL , including 76 with hearing loss in low-middle frequencies , 43 in middle-high frequencies , 162 in all frequencies and 157 in total deafness , were randomly divided into two groups , the systemic application group : dexamethasone ( DEX ) was applied by intravenous injection in dose of 10 mg3 d followed by 5 mg4 d , and the topical injection group : methylprednisolone sodium succinate of 40 mg was injected into cortical bone of mastoid region every three days .
METHODS	According to the results of pure-tone threshold audiometry , the curative effect among ISSNHL with low-middle frequencies , middle-high frequencies , all frequencies hearing loss , and total deafness were evaluated .
METHODS	SPSS 18.0 software was used to analyze the data .
RESULTS	Among 220 patients with systemic application of DEX , 66 subjects ( 30.0 % ) cases were recovery , 51 ( 23.2 % ) were excellent better , 39 ( 17.7 % ) better , 64 ( 29.1 % ) were poor , and the total effective rate was 70.9 % ( 156/220 ) .
RESULTS	There was no statistical difference in total effective rate of four typing subgroups ( ( 2 ) = 1.60 , P > 0.05 ) .
RESULTS	And the recovery rate in total deafness subgroup was significant lower than that in low-middle and all frequencies subgroups ( ( 2 ) = 10.63 and 15.94 respectively , both P < 0.05 ) .
RESULTS	In the topical injection group , the recovery rate was 30.3 % ( 66 cases ) , excellent better 18.8 % ( 41 ) , better 15.6 % ( 34 ) , poor 35.3 % ( 77 ) , and the total effective rate was 64.7 % ( 141/220 ) .
RESULTS	There were statistical differences of total effective rate in low-middle frequencies in comparison with that in all frequencies ( ( 2 ) = 8.38 ) and total deafness ( ( 2 ) = 7.28 ) subgroups ( both P < 0.05 ) .
RESULTS	Regarding recovery rate , there were significant differences between each two typing subgroups , except middle-high frequencies subgroup vs. all frequencies ( ( 2 ) = 1.60 ) and total deafness ( ( 2 ) = 2.29 ) subgroups ( both P < 0.05 ) .
RESULTS	In 76 ISSNHL with hearing loss in low-middle frequencies , the recovery rate in cases with local corticosteroids injection ( 65.0 % ) was significantly increased in comparison with that with systemic application ( 41.7 % ) , ( 2 ) = 4.15 , P < 0.05 .
RESULTS	There were increasing tendencies of curative effect in other three typing groups by systemic corticosteroids application when compared with local injection , but no statistical significances ( all P > 0.05 ) .
CONCLUSIONS	For low-middle frequencies ISSNHL , the corticosteroids administration of local injection should be the optimization .
CONCLUSIONS	Systemic application would be applied for middle-high frequencies , all frequencies and total deafness .

###24619957
OBJECTIVE	The present study investigated the efficacy of a 6-hour self-directed workbook adapted from the REACH Forgiveness intervention .
METHODS	Undergraduates ( N = 41 ) were randomly assigned to either an immediate treatment or waitlist control condition .
METHODS	Participants were assessed across 3 time periods using a variety of forgiveness outcome measures .
RESULTS	The 6-hour workbook intervention increased forgiveness , as indicated by positive changes in participants ' forgiveness ratings that differed by condition .
RESULTS	In addition , benchmarking analysis showed that the self-directed workbook intervention is at least as efficacious as the delivery of the REACH Forgiveness model via group therapy .
CONCLUSIONS	A self-directed workbook intervention adapted from the REACH Forgiveness intervention provides an adjunct to traditional psychotherapy that could assist the mental health community to manage the burden of unforgiveness among victims of interpersonal harm .

###24713489
OBJECTIVE	Although renal sinus fat invasion has prognostic significance in patients with renal cell carcinomas ( RCCs ) , there are no previous studies about the value of multidetector computed tomography ( MDCT ) about this issue in the current literature .
METHODS	A total of 863 consecutive patients ( renal sinus fat invasion in 110 patients ( 12.7 % ) ) from single institutions with surgically-confirmed renal cell carcinoma who underwent MDCT between 2010 and 2012 were included in this study .
METHODS	The area under the curves ( AUCs ) of the receiver operating characteristic ( ROC ) analysis was used to compare diagnostic performance .
METHODS	Reference standard was pathologic examination .
METHODS	Weighted statistics were used to measure the level of interobserver agreement .
METHODS	Multivariate logistic regression model was used to find the predictors for renal sinus fat invasion .
METHODS	Image analysis was first performed with axial-only CT images .
METHODS	A second analysis was then performed with both axial and coronal CT images .
METHODS	A qualitative analysis was then conducted by two reviewers who reached consensus regarding tumor size , decreased perfusion , tumor margin , vessel displacement , and lymph node metastasis .
METHODS	The reference standard was pathologic evaluation .
RESULTS	The AUCs of the ROC analysis were 0.881 and 0.922 for axial-only images and 0.889 and 0.902 for combined images in both readers .
RESULTS	The AUC of tumor size was 0.884 , a similar value to that of the reviewers .
RESULTS	In multivariate analysis , tumor size , a linear-nodular or nodular type of fat infiltration , and an irregular tumor margin were independent predicting factors for perinephric fat invasion .
CONCLUSIONS	MDCT shows relatively high diagnostic performance in detecting perinephric fat invasion of RCC but suffers from a relatively low PPV related to low prevalence of renal sinus fat invasion .
CONCLUSIONS	Applying tumor size alone we could get similar diagnostic performance to those of radiologists .
CONCLUSIONS	Tumor size , fat infiltration with a nodular appearance , and an irregular tumor margin were predictors for perinephric invasion .

###24347531
BACKGROUND	Quality of life ( QOL ) of patients receiving home parenteral nutrition ( HPN ) may be impacted by device technology .
BACKGROUND	Historically , our HPN patients used pole-mounted pumps which can hinder activities and affect QOL .
METHODS	Patients receiving HPN with a pole-mounted pump completed Short Form 36 ( SF-36 ) and pump-specific questionnaires .
METHODS	Patients were then enrolled in a 2-month prospective crossover open study .
METHODS	Patients were randomized to use a pole-mounted pump or a portable pump .
METHODS	After 1 month , each arm crossed over .
METHODS	Measurements were repeated at 4 and 8 weeks .
RESULTS	Participants included 5 males , 15 females ; age 52.8 3.3 ( mean SEM ) years ; 50 % had short bowel syndrome ; received HPN for 83.3 15.9 months ; infused HPN over 11.2 0.3 hours/day ; 4.3 0.4 days/week .
RESULTS	Portable pump users scored 53.75 5.64 , 61.25 6.14 , and 40.31 4.94 in SF-36v2 physical , social , and health vitality , respectively , while the stationary pump users scored 45.50 4.82 , 55.00 5.97 , and 35.31 4.63 , respectively ( NS ) .
RESULTS	They reported ease of movement between rooms ( 4.11 0.21 vs 1.44 0.20 ; P = .001 ) ; when traveling ( 5.00 0.00 vs 3.00 0.45 ; P < .02 ) ( 1 = very difficult , 5 = very easy ) ; 5.0 % were sleep disturbed with the portable compared to 42.1 % with pole-mounted pump ( P < .04 ) .
RESULTS	Overall , patients were significantly happier with the portable vs pole-mounted pump ( 4.53 0.19 vs 2.68 0.22 ; P < .001 ) ( 1 = very unhappy , 5 = very happy ) .
CONCLUSIONS	Our HPN patients reported improved happiness and satisfaction regarding ease of use and function with a portable vs pole-mounted pump .

###24392946
OBJECTIVE	We aimed to evaluate the surrogacy of bone mineral density and bone turnover markers for incident vertebral fracture using data from 237 patients treated with once weekly 56.5 g teriparatide or placebo .
METHODS	This analysis was conducted using data from the Teriparatide Once-Weekly Efficacy Research trial , a randomized , double-blind , placebo-controlled trial for patients with severe osteoporosis in Japan .
METHODS	A total of 237 subjects ( placebo group , n = 130 ; teriparatide group , n = 107 ) were assessed at baseline and at 72 weeks .
METHODS	Main outcome measures included estimation of the treatment effects of once weekly teriparatide on vertebral fracture risk reduction using percentage changes in lumbar bone mineral density and bone turnover markers .
RESULTS	The percentage change in lumbar bone mineral density was 6.69 % in the teriparatide group compared with 0.28 % in the placebo group ( p < 0.01 ) .
RESULTS	One incident vertebral fracture occurred in the teriparatide group compared with 16 in the placebo group .
RESULTS	The unadjusted and adjusted hazard ratios of the teriparatide group compared with the placebo group were 0.07 ( 95 % confidence interval : 0.01 to 0.56 ) and 0.64 ( 95 % confidence interval : 0.06 to 6.36 ) , respectively .
RESULTS	The proportion of treatment effect explained by changes in lumbar bone mineral density was 83 % ( Freedman 's method ) and 66 % ( Chen 's method ) .
RESULTS	There were no notable changes in hazard ratios if we adjusted for bone turnover markers .
CONCLUSIONS	Most of the vertebral fracture risk reduction with once weekly 56.5 g teriparatide is explained by changes in lumbar bone mineral density rather than changes in bone turnover markers .

###24522288
OBJECTIVE	Poor sleep hygiene including sleeping in the daytime or with the lights on at night is discovered during the assessment of many sleep disorders including sleep apnea .
OBJECTIVE	The aim of this study was to investigate whether environmental light affected autonomic control of heart rate , sleep-disordered breathing ( SDB ) , and/or breathing patterning .
METHODS	Seventeen non-obese healthy volunteers without witnessed snoring and apneas were recruited .
METHODS	Studies were performed at home using a type 3 portable monitor combined with actigraphy for sleep-wake timing , using a randomly assigned , crossover between dark , or 1,000 lx of fluorescent lighting environment .
METHODS	The outcomes were low-frequency power divided by high-frequency power ( LF/HF ratio ) in the analysis of heart rate variability , the apnea-hypopnea index ( AHI ) , and ventilatory pattern variability before and after sleep onset between environments .
RESULTS	The LF/HF ratio and AHI were both significantly higher in light as compared to dark .
RESULTS	Before sleep onset , the coefficient of variation ( CV ) for breath-to-breath tidal volume representing breathing irregularity tended to be higher in light than in dark environment .
RESULTS	The CV values for tidal volume after sleep onset were significantly decreased compared with before sleep onset in both sleep environments .
RESULTS	Mutual information of the ventilatory pattern was significantly lower before sleep onset than after sleep onset , only in the light environment .
CONCLUSIONS	Sleeping in the light has effects like that of a stressor as it is associated with neuroexcitation , SDB , and resting breathing irregularity in healthy volunteers .
CONCLUSIONS	These findings may be relevant to many sleep disorders associated with poor sleep hygiene .

###24355668
BACKGROUND	Despite evidence that daily self-weighing is an effective strategy for weight control , concerns remain regarding the potential for negative psychological consequences .
OBJECTIVE	The goal of the study was to examine the impact of a daily self-weighing weight-loss intervention on relevant psychological constructs .
METHODS	A 6-month RCT .
METHODS	The study sample ( N = 91 ) included overweight men and women in the Chapel Hill NC area .
METHODS	Between February and August 2011 , participants were randomly assigned to a daily self-weighing intervention or delayed-intervention control group .
METHODS	The 6-month intervention included daily self-weighing for self-regulation of diet and exercise behaviors using an e-scale that transmitted weights to a study website .
METHODS	Weekly e-mailed lessons and tailored feedback on daily self-weighing adherence and weight-loss progress were provided .
METHODS	Self-weighing frequency was measured throughout the study using e-scales .
METHODS	Weight was measured in-clinic at baseline , 3 months , and 6 months .
METHODS	Psychological outcomes were assessed via self-report at the same time points .
RESULTS	In 2012 , using linear mixed models and generalized estimating equation models , there were no significant differences between groups in depressive symptoms , anorectic cognitions , disinhibition , susceptibility to hunger , and binge eating .
RESULTS	At 6 months , there was a significant group X time interaction for body dissatisfaction ( p = 0.007 ) and dietary restraint ( p < 0.001 ) , with the intervention group reporting lower body dissatisfaction and greater dietary restraint compared to controls .
CONCLUSIONS	Results indicate that a weight-loss intervention that focuses on daily self-weighing does not cause adverse psychological outcomes .
CONCLUSIONS	This suggests that daily self-weighing is an effective and safe weight-control strategy among overweight adults attempting to lose weight .
BACKGROUND	This study is registered at clinicaltrials.gov NCT01369004 .

###24252475
BACKGROUND	Depression is a mental health condition which affects millions of people each year , with worldwide rates increasing .
BACKGROUND	Cognitive behavioral therapy ( CBT ) is recommended in the National Institute for Health and Clinical Excellence ( NICE ) guidelines for the treatment of depression .
BACKGROUND	However , waiting lists can cause delays for face-to-face therapy .
BACKGROUND	Also a proportion of people decline to present for help through the health service - the so-called treatment gap .
BACKGROUND	Self-referral to CBT using community-based group interventions delivered by a voluntary sector organization may serve to resolve this problem .
BACKGROUND	The aim of this randomized controlled trial ( RCT ) is to determine the efficacy of such a guided CBT self-help course , the ` Living Life to the Full ' ( LLTTF ) classes delivered by the charity Action on Depression ( AOD ) .
BACKGROUND	The primary outcome is level of depression at 6 months assessed using the patient health questionnaire-9 ( PHQ9 ) depression scale .
BACKGROUND	Secondary measures include levels of anxiety and social functioning .
METHODS	Participants with symptoms of low mood will be recruited from the community through newspaper adverts and also via the AOD website .
METHODS	Participants will receive either immediate or delayed access to guided CBT self-help classes - the eight session LLTTF course .
METHODS	The primary endpoint will be at 6 months at which point the delayed group will be offered the intervention .
METHODS	Levels of depression , anxiety and social functioning will be assessed and an economic analysis will be carried out .
CONCLUSIONS	This RCT will test whether the LLTTF intervention is effective and/or cost-effective .
CONCLUSIONS	If the LLTTF community-based classes are found to be cost effective , they may be helpful as both an intervention for those already seeking care in the health service , as well as those seeking help outside that setting , widening access to psychological therapy .
BACKGROUND	Current Controlled Trials ISRCTN86292664 .

###25180056
BACKGROUND	High levels of oxidative stress can have considerable impact on the outcomes of in vitro fertilisation ( IVF ) .
BACKGROUND	Recent studies have reported that melatonin , a neurohormone secreted from the pineal gland in response to darkness , has significant antioxidative capabilities which may protect against the oxidative stress of infertility treatment on gametes and embryos .
BACKGROUND	Early studies of oral melatonin ( 3-4mg / day ) in IVF have suggested favourable outcomes .
BACKGROUND	However , most trials were poorly designed and none have addressed the optimum dose of melatonin .
BACKGROUND	We present a proposal for a pilot double-blind randomised placebo-controlled dose-response trial aimed to determine whether oral melatonin supplementation during ovarian stimulation can improve the outcomes of assisted reproductive technology .
METHODS	We will recruit 160 infertile women into one of four groups : placebo ( n = 40 ) ; melatonin 2mg twice per day ( n = 40 ) ; melatonin 4mg twice per day ( n = 40 ) and melatonin 8mg twice per day ( n = 40 ) .
METHODS	The primary outcome will be clinical pregnancy rate .
METHODS	Secondary clinical outcomes include oocyte number/quality , embryo number/quality and fertilisation rate .
METHODS	We will also measure serum melatonin and the oxidative stress marker , 8-hydroxy-2 ' - deoxyguanosine at baseline and after treatment and levels of these in follicular fluid at egg pick-up .
METHODS	We will investigate follicular blood flow with Doppler ultrasound , patient sleepiness scores and pregnancy complications , comparing outcomes between groups .
METHODS	This protocol has been designed in accordance with the SPIRIT 2013 Guidelines .
BACKGROUND	Ethical approval has been obtained from Monash Health HREC ( Ref : 13402B ) , Monash University HREC ( Ref : CF14/523 -2014000181 ) and Monash Surgical Private Hospital HREC ( Ref : 14107 ) .
BACKGROUND	Data analysis , interpretation and conclusions will be presented at national and international conferences and published in peer-reviewed journals .
BACKGROUND	ACTRN12613001317785 .

###25641761
BACKGROUND	Women with urinary incontinence ( UI ) frequently present with complaints of sexual problems .
OBJECTIVE	To evaluate the predictors of sexual function improvement after participating in three physical therapy sessions and performing home-based pelvic floor muscle exercises ( PFME ) for the treatment of female UI .
METHODS	This is a secondary analysis of a randomized trial with a 3-month follow-up in which the sexual function of 54 women with UI was evaluated .
METHODS	These women joined three supervised physiotherapy sessions that included PFME and health education during 1 month , with a 15-day interval between each session , and kept practicing home-based PFME for a further 2 months .
METHODS	Sexual function was assessed using the FemaleSexualQuotient , the pelvic floor muscle strength was measured using the modified Oxford scale , and UI was assessed using the InternationalConsultation onIncontinenceQuestionnaire .
RESULTS	The mean of sexual quotient score improved after treatment ( P = 0.001 ) .
RESULTS	With respect to specific domains of sexual function , improvement was observed only in the questions about sexual desire , arousal/excitement , and orgasm .
RESULTS	Before treatment , 18 women ( 33.3 % ) were classified as having sexual dysfunction , and after treatment , eight remained with sexual dysfunction and two other joined this category ( total of 18.5 % ) .
RESULTS	Those women who had sexual dysfunction at baseline experienced a higher level of improvement of the sexual quotient compared with those without sexual dysfunction ( P = 0.001 , 95 % CI = 9.1-31 .9 ) .
RESULTS	A multivariate linear regression with backward elimination revealed the following predictors of improvement of the sexual quotient : higher parity , higher adherence to PFME , improvement in the strength of PFM , and a decrease in the frequency of urine leakage ( R ( 2 ) = 0.497 ) .
CONCLUSIONS	PFME was more beneficial with regard to sexual function in those women who presented with sexual dysfunction at baseline .

###26427106
OBJECTIVE	To evaluate the clinical efficacy of Zhenjingdingzhi decoction in treating insomnia with Qi-deficiency of heart and gallbladder .
METHODS	We conducted a double-blind , randomized , controlled trial involving 100 patients with insomnia of Qi-deficiency of heart and gallbladder .
METHODS	Patients were randomly divided into the treatment group ( n = 50 ) and the control group ( n = 50 ) according to a random number table .
METHODS	The treatment group was given Zhenjingdingzhi decoction , while the control group was treated with Suanzaoren decoction .
METHODS	The pharmacological treatment lasted for 8 weeks .
METHODS	The clinical efficacy was assessed by using Spiegel scale , Pittsburgh sleep quality index ( PSQ ) and Traditional Chinese Medicine ( TCM ) syndrome scores .
RESULTS	Comparing Spiegel scores between the two groups at 4 and 8 weeks , the differences in curative effect between the two groups were both significant ( both P < 0.05 ) .
RESULTS	The total effective rate was 46 % in the treatment group and 27.7 % in the control group at 4 weeks , and 80 % and 53.2 % at 8 weeks , respectively ; After 8 weeks , PSQI scores showed that the total effective rates differed significantly between the two groups ( P < 0.01 ) : 84 % in the treatment group and 59.6 % in the control group ; In improving sleep quality and sleep duration , the curative effect of the treatment group was better than that of the control group ( P < 0.05 ) .
RESULTS	TCM syndrome , especially insomnia and palpitation , was improved better in the treatment group after 8 weeks as compared to that in the control group ( P < 0.05 ) .
RESULTS	The total effective rate of the two groups was 84 % and 66 % , respectively .
CONCLUSIONS	Zhenjingdingzhi decoction is effective and safe for the treatment of insomnia with Qi-deficiency of heart and gallbladder , especially for improving sleep quality and sleep duration .

###24502859
OBJECTIVE	To evaluate the efficacy and safety of aripiprazole versus placebo in preventing relapse of irritability symptoms associated with autistic disorder in pediatric patients .
METHODS	This multicenter , double-blind , randomized , placebo-controlled , relapse-prevention trial enrolled patients ( 6-17 years ) who met the current Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , Text Revision ( DMS-IV-TR ) criteria for autistic disorder and who also had serious behavioral problems ( ie , tantrums , aggression , self-injurious behavior , or a combination of these behavioral problems ) between March 2011 and June 2012 .
METHODS	In phase 1 , single-blind aripiprazole was flexibly dosed ( 2-15 mg/d ) for 13-26 weeks .
METHODS	Patients with a stable response ( 25 % decrease in Aberrant Behavior Checklist-irritability subscale score and a rating of `` much improved '' or `` very much improved '' on the Clinical Global Impressions-Improvement scale ) for 12 consecutive weeks were randomized into phase 2 to continue aripiprazole or switch to placebo .
METHODS	Treatment was continued until relapse or up to 16 weeks .
METHODS	The primary end point was time from randomization to relapse .
RESULTS	Eighty-five patients were randomized in phase 2 .
RESULTS	The difference in time to relapse between aripiprazole and placebo was not statistically significant ( P = .097 ) .
RESULTS	Kaplan-Meier relapse rates at week 16 were 35 % for aripiprazole and 52 % for placebo ( hazard ratio [ HR ] = 0.57 ; number needed to treat [ NNT ] = 6 ) .
RESULTS	The most common adverse events during phase 1 were weight increase ( 25.2 % ) , somnolence ( 14.8 % ) , and vomiting ( 14.2 % ) ; and , during phase 2 ( aripiprazole vs placebo ) , they were upper respiratory tract infection ( 10.3 % vs 2.3 % ) , constipation ( 5.1 % vs 0 % ) , and movement disorder ( 5.1 % vs 0 % ) .
CONCLUSIONS	In this study , there was no statistically significant difference between aripiprazole and placebo in time to relapse during maintenance therapy .
CONCLUSIONS	However , the HR and NNT suggest some patients will benefit from maintenance treatment .
CONCLUSIONS	Patients receiving aripiprazole should be periodically reassessed to determine the continued need for treatment .
BACKGROUND	ClinicalTrials.gov identifier : NCT01227668 .

###24419239
BACKGROUND	This preplanned subset analysis of the phase III MONET1 study aimed to determine whether motesanib combined with carboplatin/paclitaxel ( C/P ) would result in improved overall survival ( OS ) versus chemotherapy alone , in a subset of Asian patients with nonsquamous nonsmall-cell lung cancer ( NSCLC ) .
METHODS	Patients with nonsquamous NSCLC ( stage IIIB/IV or recurrent ) and no prior systemic therapy for advanced disease were randomized to IV carboplatin ( AUC , 6 mg/ml min ) and paclitaxel ( 200 mg/m2 ) for up to six 3-week cycles , plus either oral motesanib 125 mg q.d. or placebo .
METHODS	Primary end point was OS ; secondary end points included progression-free survival ( PFS ) , objective response rate ( ORR ) , and safety .
RESULTS	Two hundred twenty-seven Asian patients from MONET1 were included in this descriptive analysis .
RESULTS	Median OS was 20.9 months in the motesanib plus C/P arm and 14.5 months in the placebo plus C/P arm ( P = 0.0223 ) ; median PFS was 7.0 and 5.3 months , respectively , ( P = 0.0004 ) ; and ORR was 62 % and 27 % , respectively , ( P < 0.0001 ) .
RESULTS	Grade3 adverse events were more common in the motesanib plus C/P arm versus placebo plus C/P ( 79 % versus 61 % ) .
CONCLUSIONS	In this preplanned subset analysis of Asian patients with nonsquamous NSCLC , motesanib plus C/P significantly improved OS , PFS , and ORR versus placebo plus C/P .
BACKGROUND	NCT00460317 .

###24517167
BACKGROUND	The model of Family group-conferencing ( FG-c ) for decision making in child welfare has rapidly spread over the world during the past decades .
BACKGROUND	Its popularity is likely to be caused by its philosophy , emphasizing participation and autonomy of families , rather than based on positive research outcomes .
BACKGROUND	Conclusive evidence regarding the ( cost ) effectiveness of FG-c is not yet available .
BACKGROUND	The aim of this protocol is to describe the design of a study to evaluate the ( cost ) effectiveness of FG-c as compared to Treatment as Usual .
METHODS	The effectiveness of FG-c will be examined by means of a Randomized Controlled Trial .
METHODS	A multi-informant approach will be used to assess child safety as the primary outcome , and commitment of the social network , perceived control / empowerment ; family functioning and use of professional care as secondary outcomes .
METHODS	Implementation of FG-c , characteristics of family manager and family will be examined as moderators of effectiveness .
CONCLUSIONS	Studying the effectiveness of Fg-c is crucial now the method is being implemented all over the world as a decision making model in child and youth care .
CONCLUSIONS	Policy makers should be informed whether the ideals of participation in society and the right for self-determination indeed result in more effective care plans , and the money spent on FG-c is warranted .
BACKGROUND	Dutch Trial Register number NTR4320 .
BACKGROUND	The design of this study is approved by the independent Ethical Committee of the Faculty of Social and Behavioral Sciences of The University of Amsterdam ( approval number : 2013-POWL-3308 ) .
BACKGROUND	This study is financially supported by a grant from ZonMw , The Netherlands Organization for Health Research and Development , grant number : 70-72900-98-13158 .

###24576321
BACKGROUND	Recent studies involving phototherapy applied prior to exercise have demonstrated positive results regarding the attenuation of muscle fatigue and the expression of biochemical markers associated with recovery .
BACKGROUND	However , a number of factors remain unknown , such as the ideal dose and application parameters , mechanisms of action and long-term effects on muscle recovery .
BACKGROUND	The aims of the proposed project are to evaluate the long-term effects of low-level laser therapy on post-exercise musculoskeletal recovery and identify the best dose andapplication power/irradiation time .
METHODS	A double-blind , randomized , placebo-controlled clinical trial with be conducted .
METHODS	After fulfilling the eligibility criteria , 28 high-performance athletes will be allocated to four groups of seven volunteers each .
METHODS	In phase 1 , the laser power will be 200 mW and different doses will be tested : Group A ( 2 J ) , Group B ( 6 J ) , Group C ( 10 J ) and Group D ( 0 J ) .
METHODS	In phase 2 , the best dose obtained in phase 1 will be used with the same distribution of the volunteers , but with different powers : Group A ( 100 mW ) , Group B ( 200 mW ) , Group C ( 400 mW ) and Group D ( 0 mW ) .
METHODS	The isokinetic test will be performed based on maximum voluntary contraction prior to the application of the laser and after the eccentric contraction protocol , which will also be performed using the isokinetic dynamometer .
METHODS	The following variables related to physical performance will be analyzed : peak torque/maximum voluntary contraction , delayed onset muscle soreness ( algometer ) , biochemical markers of muscle damage , inflammation and oxidative stress .
CONCLUSIONS	Our intention , is to determine optimal laser therapy application parameters capable of slowing down the physiological muscle fatigue process , reducing injuries or micro-injuries in skeletal muscle stemming from physical exertion and accelerating post-exercise muscle recovery .
CONCLUSIONS	We believe that , unlike drug therapy , LLLT has a biphasic dose-response pattern .
BACKGROUND	The protocol for this study is registered with the Protocol Registry System , ClinicalTrials.gov identifier NCT01844271 .

###25567765
BACKGROUND	Patients with severe limb ischemia may not be eligible for conventional therapeutic interventions .
BACKGROUND	Pioneering clinical trials suggest that bone marrow-derived cell therapy enhances neovascularization , improves tissue perfusion , and prevents amputation .
BACKGROUND	The objective of this trial was to determine whether repetitive intra-arterial infusion of bone marrow mononuclear cells ( BMMNCs ) in patients with severe , nonrevascularizable limb ischemia can prevent major amputation .
RESULTS	The Rejuvenating Endothelial Progenitor Cells via Transcutaneous Intra-arterial Supplementation ( JUVENTAS ) trial is a randomized , double-blind , placebo-controlled clinical trial in 160 patients with severe , nonrevascularizable limb ischemia .
RESULTS	Patients were randomly assigned to repetitive ( 3 times ; 3-week interval ) intra-arterial infusion of BMMNC or placebo .
RESULTS	No significant differences were observed for the primary outcome , ie , major amputation at 6 months , with major amputation rates of 19 % in the BMMNC versus 13 % in the placebo group ( relative risk , 1.46 ; 95 % confidence interval , 0.62-3 .42 ) .
RESULTS	The safety outcome ( all-cause mortality , occurrence of malignancy , or hospitalization due to infection ) was not significantly different between the groups ( relative risk , 1.46 ; 95 % confidence interval , 0.63-3 .38 ) , neither was all-cause mortality at 6 months with 5 % versus 6 % ( relative risk , 0.78 ; 95 % confidence interval , 0.22-2 .80 ) .
RESULTS	Secondary outcomes quality of life , rest pain , ankle-brachial index , and transcutaneous oxygen pressure improved during follow-up , but there were no significant differences between the groups .
CONCLUSIONS	Repetitive intra-arterial infusion of autologous BMMNCs into the common femoral artery did not reduce major amputation rates in patients with severe , nonrevascularizable limb ischemia in comparison with placebo .
CONCLUSIONS	The general improvement in secondary outcomes during follow-up in both the BMMNC and the placebo group , as well , underlines the essential role for placebo-controlled design of future trials .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00371371 .

###25802345
BACKGROUND	Folate and vitamin B-12 are important for growth .
BACKGROUND	Many children in low - and middle-income countries have inadequate intakes of these nutrients .
METHODS	We undertook a randomized , placebo controlled double-blind trial in 1000 North Indian children , 6 to 35 months of age , providing twice the recommended daily allowance of folic acid and/or vitamin B-12 , or placebo , daily for 6 months .
METHODS	By using a factorial design , we allocated children in a 1:1:1:1 ratio in blocks of 16 .
METHODS	We measured the effect of giving vitamin B-12 , folic acid , or the combination of both on linear and ponderal growth .
METHODS	We also identified predictors for growth in multiple linear regression models and effect modifiers for the effect of folic acid or vitamin B-12 supplementation on growth .
RESULTS	The overall effect of either of the vitamins was significant only for weight ; children who received vitamin B-12 increased their mean weight-for-age z scores by 0.07 ( 95 % confidence interval : 0.01 to 0.13 ) .
RESULTS	Weight-for-age z scores and height-for-age z scores increased significantly after vitamin B-12 supplementation in wasted , underweight , and stunted children .
RESULTS	These subgrouping variables significantly modified the effect of vitamin B-12 on growth .
RESULTS	Vitamin B-12 status at baseline predicted linear and ponderal growth in children not receiving vitamin B-12 supplements but not in those who did ( P-interaction < .001 ) .
CONCLUSIONS	We provide evidence that poor vitamin B-12 status contributes to poor growth .
CONCLUSIONS	We recommend studies with larger doses and longer follow-up to confirm our findings .

###25572618
OBJECTIVE	To evaluate the effectiveness of a single-session online theory of planned behaviour ( TPB ) - based intervention to improve sun-protective attitudes and behaviour among Australian adults .
METHODS	Australian adults ( N = 534 ; 38.7 % males ; Mage = 39.3 years ) from major cities ( 80.9 % ) , regional ( 17.6 % ) and remote areas ( 1.5 % ) were recruited and randomly allocated to an intervention ( N = 265 ) and information only group ( N = 267 ) .
METHODS	The online intervention focused on fostering positive attitudes , perceptions of normative support , and control perceptions for sun protection .
METHODS	Participants completed questionnaires assessing standard TPB measures ( attitude , subjective norm , perceived behavioural control , intention , behaviour ) and extended TPB constructs of group norm ( friends , family ) , personal norm , and image norm , pre-intervention ( Time 1 ) and one week ( Time 2 ) and one month post-intervention ( Time 3 ) .
METHODS	Repeated Measures Multivariate Analysis of Variance tested intervention effects across time .
RESULTS	Intervention participants reported more positive attitudes towards sun protection and used sun-protective measures more often in the subsequent month than participants receiving information only .
RESULTS	The intervention effects on control perceptions and norms were non-significant .
CONCLUSIONS	A theory-based online intervention fostering more favourable attitudes towards sun safety can increase sun protection attitudes and self-reported behaviour among Australian adults in the short term .

###24361248
BACKGROUND	The efficacy and safety of amrubicin , a third-generation synthetic anthracycline , were evaluated by comparison with carboplatin/etoposide combination therapy in elderly Japanese patients with extensive-disease small-cell lung cancer ( ED-SCLC ) .
METHODS	Eligibility included histologically or cytologically proven SCLC , no previous systemic chemotherapy , performance status of 0 to 2 , and age 70 years .
METHODS	Patients received amrubicin ( 70-74 years old , 40-45 mg/m ( 2 ) ; 75 years old , 40 mg/m ( 2 ) ) intravenously on days 1 to 3 every 3 weeks for 4 to 6 cycles or carboplatin ( area under the curve of 5 intravenously on day 1 ) and etoposide ( 80 mg/m ( 2 ) intravenously on days 1 to 3 ) every 3 weeks for 4 to 6 cycles .
RESULTS	The target number of patients was 130 with 65 in each arm .
RESULTS	However , the study was terminated early owing to 3 treatment-related deaths in the amrubicin arm , and only 62 patients ( median age , 76 years ; range , 70-88 years ) were enrolled .
RESULTS	The characteristics of the patients in the amrubicin and carboplatin/etoposide arms did not differ significantly .
RESULTS	Overall survival , time to progression , and objective response rate were 10.9 vs. 11.3 months ( P = .7353 ) , 4.7 vs. 4.4 months , and 74.2 % ( 23 of 31 ) vs. 60.0 % ( 18 of 30 ) , respectively , and quality of life showed no significant difference between the 2 arms .
RESULTS	Higher incidences of febrile neutropenia and interstitial lung disease of grade 3 or worse occurred with amrubicin ( 34.4 % vs. 3.3 % and 12.5 % vs. 0 % , respectively ) .
CONCLUSIONS	These results indicate that amrubicin monotherapy at 40 to 45 mg/m ( 2 ) is toxic and intolerable in elderly Japanese patients with ED-SCLC .

###25558034
OBJECTIVE	Our aim was to investigate the acute and 24-hour ( h ) effects of high-intensity interval training ( HIIT ) and moderate continuous training ( MCT ) on arterial pulse wave reflection , an established marker of arterial stiffness and cardiovascular risk .
METHODS	In a randomized cross-over design , 21 young healthy male participants performed a HIIT or a MCT on separate visits .
METHODS	Before and 5 ( t5 ) , 20 ( t20 ) , 35 ( t35 ) , and 50 ( t50 ) minutes after the acute exercise bouts , the crude augmentation index ( AIx ) and the AIx at a set heart rate ( AIx@75 ) were analysed by applanation tonometry .
METHODS	Starting 1h post-exercise , both indices were captured over 24-h with an oscillometric monitoring device .
RESULTS	AIx did not change significantly after MCT but declined progressively after HIIT , reaching significantly lower values compared to MCT at t35 ( P = 0.045 ) and t50 ( P = 0.008 ) .
RESULTS	AIx@75 increased after both acute exercise types but was higher after HIIT at t5 ( P < 0.001 ) , t20 ( P < 0.001 ) and t35 ( P = 0.009 ) compared to MCT .
RESULTS	The 24-h follow-up revealed a significant decline in AIx@75 after HIIT ( P = 0.007 ) but not after MCT ( P = 0.813 ) .
CONCLUSIONS	Exercise intensity affects pulse wave reflection , with different time courses for AIx and AIx@75 post-exercise .
CONCLUSIONS	Although initially higher after HIIT , AIx@75 declines in the 24-h recovery period indicating more favourable effects on pulse wave reflection compared to MCT .
CONCLUSIONS	This may result in substantial positive chronic training effects on arterial stiffness in health and cardiovascular disease .

###25854016
OBJECTIVE	To observe the differences in timely effectiveness of immediate analgesia on acute migraine between electroacupuncture ( EA ) at shaoyang meridian points and non-meridian points .
METHODS	The randomized controlled trial method was adopted .
METHODS	One hundred and ten cases of acute migraine were randomized into two groups .
METHODS	55 cases in each one .
METHODS	In the observation group , EA was applied to Fengchi ( GB 20 ) , Waiguan ( TE 5 ) , etc. .
METHODS	In the control group .
METHODS	EA was applied to non-meridian points .
METHODS	Only one treatment was given , and the nee dies were retained for 30 min in the two groups .
METHODS	Separately .
METHODS	at 10 time points , named before acupuncture , in 5 min , 10 min .
METHODS	20 min and 30 min ( at the moment of needle removal ) , 1 h , 2 h , 4 h , 6 h and 8 h after acupuncture , the pain intensity numerical rating scale ( PI-NRS ) was adopted to evaluate the pain severity and the adverse reac tion was recorded .
RESULTS	( 1 ) The effective rate of imnmediate analgesia was 87.3 % ( 48/55 ) in the observation group .
RESULTS	significantly higher than 52.7 % ( 29/55 ) in the control group ( P < 0.01 ) .
RESULTS	( 2 ) NRS of each group was re duced at each time point , from 5 min to 8 h after acupuncture ( all P < 0.01 ) .
RESULTS	( 3 ) NRS score at 30 min after acu puncture in the control group was obviously lower than that in the observation group ( P < 0.05 ) , but the scores in 2 h , 4 h , 6 h and 8 h after acupuncture in the observation group were lower apparently than those in the control group ( all P < 0.01 ) .
RESULTS	The differences in the scores in 5 min , 10 min , 20 min and 1 h after acupuncture were not significant ( all P > 0.05 ) .
RESULTS	( 4 ) For the reducing amplitude of NRS score at the same time point after acupuncture , the results in 20 min , 30 min and 1 h in the control group were higher apparently than those in the observation group ( all P < 0.05 ) .
RESULTS	But , in 2 h , 4 h , 6 h and 8 h , the results in the observation group were higher apparently than those in the control group ( all F < 0.05 ) .
RESULTS	The differences in 5 min and 10 min after acupuncture were not significant ( both P > 0.05 ) .
RESULTS	( 5 ) In 24 h after acupuncture , the recurrence rate of migraine was 12.7 % ( 7/55 ) in the observation group , which was lower obviously than 34.5 % ( 19/55 ) in the control group ( P < 0.05 ) .
RESULTS	The adverse reaction was not found in the two groups .
CONCLUSIONS	EA at the shaoyang meridian points achieves the definite immediate analgesia effect on acute migraine and presents the time effectiveness of analgesia .

###24475598
OBJECTIVE	This study aimed to assess the effectiveness of a blended-teaching intervention using Internet-based tutorials coupled with traditional lectures in an introduction to research undergraduate nursing course .
OBJECTIVE	Effects of the intervention were compared with conventional , face-to-face classroom teaching on three outcomes : knowledge , satisfaction , and self-learning readiness .
METHODS	A two-group , randomized , controlled design was used , involving 112 participants .
METHODS	Descriptive statistics and analysis of covariance ( ANCOVA ) were performed .
RESULTS	The teaching method was found to have no direct impact on knowledge acquisition , satisfaction , and self-learning readiness .
RESULTS	However , motivation and teaching method had an interaction effect on knowledge acquisition by students .
RESULTS	Among less motivated students , those in the intervention group performed better than those who received traditional training .
CONCLUSIONS	These findings suggest that this blended-teaching method could better suit some students , depending on their degree of motivation and level of self-directed learning readiness .

###24497520
BACKGROUND	Vessel wall injury after drug-eluting stent ( DES ) implantation can be characterized in detail by optical coherence tomography ( OCT ) .
BACKGROUND	Little is known about the healing course of these phenomena .
RESULTS	In 62 lesions ( 62 patients ) , the incidence of acute vessel trauma was assessed in the stented region and the edge segments immediately after DES implantation .
RESULTS	The healing course of these injuries was assessed at 9-month OCT follow-up using a software algorithm allowing for reliable spatial comparison of baseline and follow-up cross-sectional images .
RESULTS	Tissue prolapse ( TP ) and tissue protrusions were detected in 81 and 35 % of lesions , respectively .
RESULTS	A total of 342 intra-stent dissection flaps ( ISD ) and 114 intra-stent dissection cavities ( ISC ) were visualized in 98 and 81 % of lesions , respectively .
RESULTS	Thirty-five lesions ( 56 % ) showed edge dissections ( EDs ) .
RESULTS	No residual TP or protrusion was observed at follow-up .
RESULTS	Incomplete healing was seen in 8 % of ISD and in 20 % of ISC .
RESULTS	For ED , a residual flap was observed in one-third of the initially dissected stent edges .
RESULTS	Incomplete healing of acute vessel injury was associated with the presence of underlying atherosclerotic disease at baseline .
RESULTS	Uncovered and malapposed stent struts were observed more often with incomplete healing of vessel injury at follow-up .
CONCLUSIONS	Acute vessel wall trauma is highly prevalent immediately after DES implantation .
CONCLUSIONS	Most of these injuries are minor and resolve at mid-term follow-up .
CONCLUSIONS	Incomplete healing of ISDs seems to be associated with other OCT findings suggesting delayed arterial healing .

###25862800
OBJECTIVE	We hypothesized that integrated motor-visual functions measured by manipulative manual dexterity are affected by white matter lesion ( WML ) burden as measured on cranial MRI across relevant brain regions in subjects at risk of preclinical occult vascular disease .
METHODS	A real-time cross-sectional study of healthy subjects aged 29 to 74 years with a family history of early-onset coronary artery disease ( n = 714 ; mean age , 51 11 years ; mean education , 14 3 years ; 42 % male ; 38 % black ) were identified from probands with coronary artery disease diagnosed before age 60 years .
METHODS	WMLs on 3-tesla brain MRI and Grooved Pegboard scores were measured .
RESULTS	WMLs were observed at all ages .
RESULTS	Mean pegboard scores were 108 18 , similar to normal populations .
RESULTS	In unadjusted analysis , WMLs and pegboard scores were significantly correlated by region ( total WMLs , r = 0.34 , p = 0.0001 ; frontal [ r = 0.34 , p < 0.0001 ] , insula [ r = 0.31 , p < 0.0001 ] , parietal [ r = 0.31 , p < 0.0001 ] , and temporal [ r = 0.17 , p < 0.0001 ] ) .
RESULTS	In multivariate analysis predicting ( log ) pegboard score adjusted for age , sex , race , education , regional or total volumes , and familial non-independence , total WML volume ( p = 5.79 E - 05 ) and regional WML volumes ( p < 0.01 ) retained statistical significance in all but the youngest age quartile ( 29-43 years ) .
CONCLUSIONS	Greater WML volumes in different brain regions are associated with higher pegboard scores ( worse performance ) independent of age , sex , race , education , and total or regional volumes .
CONCLUSIONS	This suggests that small vessel cerebrovascular disease may be present in healthy individuals in a preclinical state with measurable impact on complex integrative functions in individuals with excess risk of clinical vascular disease .

###24330475
OBJECTIVE	We examined the durability of the virological response after discontinuing lamivudine ( LVD ) in chronic hepatitis B ( CHB ) patients with LVD-resistant hepatitis B virus ( HBV ) , who responded to LVD plus adefovir ( ADV ) combination therapy , and the outcome of switching to ADV monotherapy compared to maintaining combination therapy .
METHODS	This study enrolled 72 patients with undetectable viral loads ( 12 IU/ml ) and normal alanine aminotransferase levels after ADV add-on therapy for at least 6 months in LVD-resistant CHB patients .
METHODS	The enrolled patients were randomly assigned to continue with LVD-ADV combination therapy or switch to ADV monotherapy ( n = 36 per group ) .
METHODS	Virological rebound was defined as HBV DNA detection at more than 12 IU/ml by quantitative polymerase chain reaction determined on two consecutive measurements .
RESULTS	During 96 weeks of follow-up , 100 % ( 36/36 ) of the patients in the LVD-ADV combination maintained group had persistently undetectable HBV DNA , compared with 94.4 % ( 34/36 ) patients in the ADV monotherapy switched group .
RESULTS	These two patients had undetectable HBV DNA after switching back to LVD-ADV combination therapy .
RESULTS	There were no significant differences in the HBsAg levels between the two treatment groups during the 96-week follow-up period .
CONCLUSIONS	In our study , switching to ADV monotherapy resulted in sustained HBV DNA suppression in 94.4 % of the patients for 96 weeks .
CONCLUSIONS	Prior complete viral suppression with LVD-ADV combination therapy conferred a significant advantage in patients who switched to ADV monotherapy .
CONCLUSIONS	LVD may be discontinued in patients who show a complete virological response to LVD-ADV combination therapy for at least 6 months .

###25945550
BACKGROUND	Rapid travel over multiple time zones usually results in transient de-synchronization between environmental time and the biological clock of the individual .
BACKGROUND	Common symptoms are increased daytime sleepiness , reduced sleep duration and quality , and performance impairments .
BACKGROUND	Exposure to ocular bright light is known to alleviate jet lag symptoms and facilitate adaptation to a new time zone .
BACKGROUND	Recently , transcranial bright light ( TBL ) via the ear canals has been shown to have antidepressant , anxiolytic , and psychomotor performance-enhancing effects .
BACKGROUND	In this case we studied whether intermittent TBL exposure can alleviate jet lag symptoms in a randomized , double-blind , placebo-controlled study .
METHODS	Intermittent light exposures ( 4 12 min ; day 0 : 08:00 , 10:00 , 12:00 , 14:00 ; days 1-6 : 10:00 , 12:00 , 14:00 , 16:00 ) were administered during the 7-d post-travel period after an eastward transatlantic flight .
METHODS	The symptoms of jet lag were measured by the Visual Analog Scale ( VAS ) , the Karolinska Sleepiness Scale ( KSS ) , and the Profile of Mood States ( POMS ) .
RESULTS	We found a significant reduction of overall jet lag symptoms ( VAS ) , subjective sleepiness ( KSS ) , and the fatigue , inertia , and forgetfulness subscales of the POMS when comparing the active TBL treatment group ( N = 30 ) to the placebo group ( N = 25 ) .
RESULTS	For example , the normalized values of VAS in the TBL , but not the placebo , group returned to pre-travel levels by the final post-travel day ( 6.16 vs. 15.34 ) .
CONCLUSIONS	Results suggest a cumulative effect of TBL , as the effects emerged on post-travel days 3-4 .
CONCLUSIONS	Intermittent TBL seems to alleviate jet lag symptoms .

###24721352
OBJECTIVE	To explore the effects of penehyclidine inhalation on the incidence of pulmonary complications in elderly patients after long-duration surgery .
METHODS	For this prospective , double-blind and randomized controlled trial , 90 elderly patients undergoing long-duration surgery ( 3 hours ) under general anesthesia and transferred into intensive care unit ( ICU ) of Peking University First Hospital during February 14 , 2012 to September 13 , 2012 were enrolled .
METHODS	After extubation , they were randomized into 3 groups to receive an inhalation of penehyclidine hydrochloride , ipratropium bromide or normal saline for 3 consecutive days .
METHODS	The primary endpoint was the incidence of pulmonary complications within 6 days post-extubation .
RESULTS	The incidence of bronchospasm was 3.3 % , 3.2 % and 20.7 % respectively .
RESULTS	And the rate of aminophylline use was 0,0 and 10.3 % respectively ( P = 0.025 and P = 0.038 ) ; the airway tract spasm-free duration within 6 days after extubation was 5.8 ( 5.5-6 .2 ) , 5.8 ( 5.5-6 .2 ) and 5.3 ( 4.8-5 .9 ) days ( P = 0.028 ) ; the overall incidence of pulmonary complications was 70.0 % , 71.0 % and 75.9 % ( P = 0.865 ) .
CONCLUSIONS	For elderly patients after long-duration surgery , a prophylactic atomizing inhalation of penehyclidine decreases the incidence of bronchospasm and the rate of aminophylline use after extubation.However , the overall incidence of pulmonary complications has no change .

###24886191
BACKGROUND	Offering the overweight or obese patient the option of choosing from a selection of weight loss diets has not been investigated in type 2 diabetes .
BACKGROUND	The aim of the study was to investigate if the option to choose from , and interchange between a selection of diets ( `` Choice '' ) , as opposed to being prescribed one set diet ( `` No Choice '' ) , improves drop out rates and leads to improved weight loss and cardio-metabolic outcomes .
METHODS	The study was a 12month , randomized parallel intervention .
METHODS	A total of 144 volunteers with type 2 diabetes or pre-diabetes and a BMI > 27 were randomized to `` No Choice '' or `` Choice '' .
METHODS	Those in the No Choice group were placed on a set weight loss diet ( CSIRO ) with no change permitted .
METHODS	Those in the Choice group could choose from , and interchange between , the CSIRO , South Beach or Mediterranean diets .
RESULTS	There were no differences in attrition rates or weight loss between the `` Choice '' and `` No Choice '' .
RESULTS	In a secondary analysis of the intention-to-treat weight loss data with last measured weight carried forward gave a highly significant diet group by time by gender interaction ( p = 0.002 ) with men doing better in the No Choice group overall ( maximum difference `` No Choice '' -2.94.6 kg vs. `` Choice '' -6.2 kg5 .3 kg at 6months ) and women doing better in the Choice group overall ( maximum difference Choice -3.13.7 kg vs. `` No Choice '' -2.0 kg2 .6 kg at 6months ) .
CONCLUSIONS	Men prefer direction in their weight loss advice and do less well with choice .
CONCLUSIONS	A gender-specific approach is recommended when prescribing weight loss diets .
BACKGROUND	anzctr.org.au ACTRN12612000310864 .

###24531024
OBJECTIVE	To determine if the location of neodymium : yttrium-aluminum-garnet laser peripheral iridotomy ( LPI ) is related to the occurrence of postoperative visual dysphotopsia .
METHODS	Randomized , prospective , single-masked , paired-eye comparative clinical trial .
METHODS	setting : Private subspecialty clinic in Mississauga , Canada .
METHODS	study population : Patients with primary angle closure or primary angle-closure suspects were recruited and randomized to receive LPI temporally in one eye and superiorly in the other .
METHODS	Patients were masked to the location of treatment in each eye .
METHODS	intervention : Temporal or superior LPI .
METHODS	main outcome measures : Occurrence of new-onset linear dysphotopsia .
METHODS	Other visual disturbances also were assessed using a questionnaire before and 1month after intervention .
METHODS	Secondary outcome measures included eyelid position , laser parameters , and any intraoperative complications .
RESULTS	A total of 208 patients were recruited to the study , of which 169 ( 84 % ) completed it .
RESULTS	New-onset linear dysphotopsia was reported in 18 ( 10.7 % ) eyes with superior LPI versus 4 ( 2.4 % ) eyes with temporal LPI ( P = .002 ) .
RESULTS	Eleven eyes ( 6.5 % ) with superior LPI reported linear dysphotopsia despite complete eyelid coverage of the iridotomy .
RESULTS	No significant differences were found with other visual disturbances between them .
RESULTS	There was more pain experienced by the temporal LPI ( 2.8 2.2 vs 2.1 2.0 ; P = .001 ) , despite no difference in laser energy or number of shots .
RESULTS	Intraoperative rates of hemorrhage were similar ( 8.9 % vs 10.1 % ; P = .71 ) .
CONCLUSIONS	Temporal placement of LPI is safe and was found to be less likely to result in linear dysphotopsia as compared with superior placement .
CONCLUSIONS	Temporal iris therefore may be considered a preferred location for LPI .

###25266432
OBJECTIVE	To examine the functional status ( mental health , academic performance , peer problems ) of a community-based sample of children who have attention-deficit/hyperactivity disorder ( ADHD ) and non-ADHD controls , and to investigate gender and subtype differences .
METHODS	Children aged 6 to 8 years were recruited through 43 Melbourne schools , using a 2-stage screening ( parent and teacher Conners 3 ADHD index ) and case confirmation ( Diagnostic Interview Schedule for Children , Version IV ; [ DISC-IV ] ) procedure .
METHODS	Outcome measures were mental health disorders ( DISC-IV ) , academic performance ( Wide Range Achievement Test 4 ) , and peer problems ( Strength and Difficulties Questionnaire ) .
METHODS	Unadjusted and adjusted linear and logistic regression were used to compare ADHD and non-ADHD controls .
RESULTS	A total of 179 children who have ADHD and 212 non-ADHD controls were recruited .
RESULTS	Compared with controls , children who had ADHD had higher odds of externalizing ( odds ratio [ OR ] , 11.0 ; 95 % confidence interval [ CI ] , 5.6-21 .6 ; P < .001 ) and internalizing ( OR , 2.9 ; 95 % CI , 1.2-7 .2 ; P = .02 ) disorders ; poorer reading ( effect size , -0.66 ) and mathematics ( effect size , -0.69 ) performance ; and more peer problems ( P < .001 ) .
RESULTS	Boys and girls who had ADHD were equally impaired .
RESULTS	Only 17 % of children in our ADHD group had been previously diagnosed .
RESULTS	Previous diagnosis was higher in the Combined group and for boys .
CONCLUSIONS	In their second year of school , children who had ADHD performed worse than controls across all functional domains , yet only a minority had been formally diagnosed with ADHD .
CONCLUSIONS	Findings highlight the need for earlier diagnosis and intervention .

###25207984
BACKGROUND	Assessment of symptoms and rescue medication use are well-established endpoints for clinical trials evaluating asthma treatment .
OBJECTIVE	To evaluate the measurement properties of an asthma symptom and rescue medication use ( ASRMU ) diary for clinical trials involving asthma patients aged 12 years .
METHODS	Interviews with 35 patients were conducted to confirm the importance of key concepts in the ASRMU diary .
METHODS	Scores of symptom and rescue medication use were converted to symptom-free days ( SFD ) and rescue-free days ( RFD ) .
METHODS	Test-retest reliability and equivalence ( based on intra-class correlation coefficients [ ICCs ] ) between paper-and-pencil and electronic ( eDiary ) versions were evaluated in a prospective study in 47 patients .
METHODS	Responsiveness of the ASRMU diary was evaluated through differences in percentage of SFD and of RFD by treatment group in eight asthma clinical trials that assessed inhaled corticosteroids ( ICS ) and long-acting 2-agonists ( LABA ) , alone or in combination .
METHODS	A ninth placebo-controlled study calculated effect sizes .
METHODS	Minimal important differences ( MID ) were determined using anchor-based methods from two trials and by interviewing 11 patients .
RESULTS	Patient interviews supported content validity for the ASRMU diary .
RESULTS	Test-retest reliability was acceptable for SFD ( ICC :0.70 -0.75 ) , but varied for RFD ( ICC :0.58 -0.78 ) .
RESULTS	Paper-and-pencil and eDiary modes of administration were equivalent ( SFD , ICC = 0.84 ; RFD , ICC = 0.70 ) .
RESULTS	ICS/LABA had the largest percentage of SFD and RFD , followed by monotherapy and then placebo .
RESULTS	MIDs were 7.7-14 .7 % for SFD and 8.4-15 .6 % for RFD .
CONCLUSIONS	The ASRMU diary captures the disease-specific concepts of greatest importance to asthma patients and provides important information for asthma diagnosis and treatment evaluation .

###25623462
OBJECTIVE	To evaluate the effect of microecologic treatment combined enteral nutrition on serum endotoxin , tumor necrosis factor - ( TNF - ) , interleukin-18 ( IL-18 ) , blood ammonia levels and nutritional status in patients with hepatic encephalopathy .
METHODS	60 patients with hepatic encephalopathy were allocted randomly into 3 groups , on the basis of conventional liver protective therapy and uragogue with one group given probiotics plus enteral nutrition , one given probiotics only , and the 3rd group given intravenous nutrition .
METHODS	The whole course of treatment was four weeks .
METHODS	Serum levels of endotoxin , TNF - , IL-18 , ammonia and albumin were determined before and on the 7th and 14th day after treatment .
RESULTS	The levels of serum endotoxin , TNF - , IL-18 and blood ammonia in the combined treatment group decreased remarkably after treatment , while the level of serum albumin elevated markedly .
RESULTS	The difference was significant at statistics as compared with the only probiotics group and intravenous nutrition group ( P < 0.05 ) .
CONCLUSIONS	Microecologic treatment combined enteral nutrition could effectively reduce blood ammonia and serum endotoxin levels , protect intestinal mucosal barrier , as well as improve nutritional status of patients with hepatic encephalopathy , which was considered as a safe and efficient therapy .

###25803245
OBJECTIVE	The aim of this study was to determine if the timing of intra-articular local anesthetic injection and the status of the suction drain affect variable pain scores after ACL reconstruction .
METHODS	The study included 40 patients undergoing arthroscopic ACL reconstruction randomized into 4 groups .
METHODS	Patients in Group 1 received intra-articular 20 ml of 0.25 % bupivacaine 20 minutes before the start of the operation ( preemptive : PE ) , Group 2 at the end of the operation with the suction drain opened ( DO ) .
METHODS	Group 3 also received intra-articular bupivacaine at the end of the operation and the drain was kept closed for one hour postoperatively ( DC ) .
METHODS	Group 4 did not receive any intra-articular injection ( control group : CG ) and served as the control group .
METHODS	Visual analog scale ( VAS ) scores and additional analgesic requirements were recorded .
RESULTS	The PE group had the lowest and the control group the highest VAS scores at the second postoperative hour .
RESULTS	At the fourth postoperative hour , VAS scores were significantly higher in the DC group than the DO group ( p < 0.05 ) .
RESULTS	At the sixth postoperative hour , the PE and DC groups had significantly lower VAS scores than the other groups ( p < 0.05 ) .
RESULTS	At Hour 12 , the PE and control groups had higher VAS scores than the DO and DC groups .
RESULTS	VAS scores were not different among groups at Hour 24 .
RESULTS	The interval to first analgesic requirement was significantly shorter in the control group and longer in the PE group in comparison to the other two groups ( p < 0.001 ) .
CONCLUSIONS	Intra-articular bupivacaine injection at different stages of the operation yielded variable VAS scores in the postoperative period .
CONCLUSIONS	Closing the drain after intra-articular injection resulted in an early onset analgesic effect without shortening the duration .

###24579474
OBJECTIVE	To investigate the prevention of diarrhea by oral BIFICO for infants aged 1-6 years .
METHODS	490 cases of infants were randomly divided after age stratification : the experimental group ( n = 247 ) and the control group ( n = 243 ) .
METHODS	Based on principles of randomized double-blind and placebo-controlled , the infants were given BIFICO ( dedicated clinical research ) therapy for 4 consecutive days , then observed for 21 days .
METHODS	25 days composed a cycle .
METHODS	They were observed total 5 cycles .
METHODS	During the study period , principles for `` the diarrhoea patients must be detected '' , follow-up visited the participant infants and conducted etiology detection by way of sampling for diarrhea infants .
METHODS	Evaluate the prevention efficacy of diarrhea by oral BIFICO for infants aged 1-6 years .
RESULTS	A total of 480 completed all study .
RESULTS	120 and 95 infants in the control group and experimental group were detected with diarrhea .
RESULTS	The incidence of diarrhea was 50.85 % and 38.93 % in these two guoup , respectively .
RESULTS	The difference has statistical significance ( chi2 = 4.175 , P = 0.041 ) .
RESULTS	In the third observation period , the infants in the control group had a higer incidence of diarrhea compared with which in the experimental group ( chi2 = 4.415 , P = 0.036 ) .
RESULTS	14 strains of rotavirus , 3 strains of norovirus , 3 strains of sappovirus , 2 strains of adenovirus , 5 strains of salmonella and 4 strains of Shigella were check out in 128 samples .
CONCLUSIONS	Oral BIFICO can paly certain preventive role on diarrhea , and decrease the incidence of diarrhea in infants aged 1-6 years .

###24739815
OBJECTIVE	To evaluate whether electroacupuncture ( EA ) at ST36 can accelerate the recovery of gastrointestinal motility after colorectal surgery .
METHODS	Forty patients of American Society of Anesthesiologists physical status II and III undergoing elective open resection of malignant colorectal tumours were included in this study .
METHODS	Using a sealed envelope method , the patients were randomly divided into two groups either receiving EA ( EA group ) or sham EA ( SEA group ) .
METHODS	Data regarding the recovery of bowel function ( times to the first bowel sounds , passage of flatus and defaecation ) were collected and analysed .
RESULTS	In the EA group , the time intervals from surgery to the first bowel movement and passage of flatus were shorter than in the SEA group ( 1310h vs 1913h , p < 0.05 and 2314h vs 3218h , p < 0.05 , respectively ) .
RESULTS	There was no significant difference between the groups regarding the time to first defaecation ( 6845h vs 7253h , p > 0.05 ) .
CONCLUSIONS	EA at ST36 accelerates the recovery of gastrointestinal motility after colorectal surgery .
BACKGROUND	JJ22011-15 .

###24289059
BACKGROUND	Medication non-adherence is considered an important cause of morbidity and mortality in primary care .
BACKGROUND	This study aims to determine the effectiveness , cost effectiveness and acceptability of a complex intervention delivered by community pharmacists , the New Medicine Service ( NMS ) , compared with current practice in reducing non-adherence to , and problems with , newly prescribed medicines for chronic conditions .
METHODS	Research subject group : patients aged 14 years and above presenting in a community pharmacy for a newly prescribed medicine for asthma/chronic obstructive pulmonary disease ( COPD ) ; hypertension ; type 2 diabetes or anticoagulant/antiplatelet agents in two geographical regions in England .
METHODS	parallel group patient-level pragmatic randomized controlled trial .
METHODS	patients randomized to either : ( i ) current practice ; or ( ii ) NMS intervention comprising pharmacist-delivered support for a newly prescribed medicine .
METHODS	proportion of adherent patients at six , ten and 26 weeks from the date of presenting their prescriptions at the pharmacy ; cost effectiveness of the intervention versus current practice at 10 weeks and 26 weeks ; in-depth qualitative understanding of the operationalization of NMS in pharmacies .
RESULTS	impact of NMS on : patients ' understanding of their medicines , pharmacovigilance , interprofessional and patient-professional relationships and experiences of service users and stakeholders.Economic analysis : Trial-based economic analysis ( cost per extra adherent patient ) and long-term modeling of costs and health effects ( cost per quality-adjusted-life-year ) will be conducted from the perspective of National Health Service ( NHS ) England , comparing NMS with current practice.Qualitative analysis : a qualitative study of NMS implementation in different community settings , how organizational influences affect NMS delivery , patterns of NMS consultations and experiences of professionals and patients participating in NMS , and patients receiving current practice .
METHODS	250 patients in each treatment arm would provide at least 80 % power ( two-tailed alpha of 0.05 ) to demonstrate a reduction in patient-reported non-adherence from 20 % to 10 % in the NMS arm compared with current practice , assuming a 20 % drop-out rate .
CONCLUSIONS	At the time of submission of this article , 58 community pharmacies have been recruited and the interventions are being delivered .
CONCLUSIONS	Analysis has not yet been undertaken .
BACKGROUND	Current controlled trials : ISRCTN23560818 .
BACKGROUND	Clinical Trials US ( clinicaltrials.gov ) : NCT01635361 .

###26521569
OBJECTIVE	To observe the clinical efficacy difference in the treatment of neonatal hypoxic ischemic encephalopathy ( NHIE ) between the combined therapy of acupuncture land acupoint injection of nerve growth fac-tor ( NGF ) and the combined therapy of the intravenous drop of citicoline sodium and intramuscular injection of NGF .
METHODS	Sixty-one cases of NHIE were randomized into an observation group ( 32 cases ) and a control group ( 29 cases ) .
METHODS	In the observation group , acupuncture combined with acupint injection of NGF was adopted .
METHODS	The acupoints were Baihui ( GV 20 ) , Dazhui ( GV 14 ) and Fengfu ( GV 16 ) , 0.5 mL each acupoint , once a day .
METHODS	In the control group , the intravenous drop of citicoline sodium and intramuscular injection of NGF were used .
METHODS	The , treatment of 7 days made one session and 3 sessions were required .
METHODS	Separately , in 7 , 14 and 21 days of treatment , the clinical efficacy , behavior nerve determination score and adverse reaction were observed in the two groups .
RESULTS	In 7 , 14 and 21 days of treatment , the total effective rates were 50.0 % ( 16/32 ) , 68.8 % ( 22/32 ) and 78.1 % ( 25/32 ) in the observation group and were 69.0 % ( 20/29 ) , 72.4 % ( 21/29 ) and 82.8 % ( 24/29 ) in the control group .
RESULTS	The result in the control group was better than that in the observation group in the 7 days ( P < 0.05 ) .
RESULTS	The behavior determination scores in 7 , 14 and 21 days were all improved obviously as compared with those before treatment in the two groups ( P < 0.05 , P < 0.01 ) .
RESULTS	The score in the control group was better than that in the , observation group in the 7 days ( P < 0.05 ) .
RESULTS	The differences were not significant in the scores between the two groups in 14 and 21 days ( both P > 0.05 ) .
RESULTS	The incidence of adverse reaction in the observation group was lower than that in , the control group [ 14.3 % ( 5/35 ) vs 31.4 % ( 11/35 ) , P < 0.05 ] and the severity was mild .
CONCLUSIONS	In the treatment of NHIE with the combined therapy of acupuncture and acupint injection , the overall efficacy in 1 week ; is inferior to that of the combined therapy of the intravenous drop of citicoline sodium and intramuscular injection of NGF .
CONCLUSIONS	But the efficacy is improved gradually along with the treatment progression and the adverse reaction is less .

###24321091
BACKGROUND	Eventual control of HIV/AIDS is believed to be ultimately dependent on a safe , effective and affordable vaccine .
BACKGROUND	Participation of sub-Saharan Africa in the conduct of HIV trials is crucial as this region still experiences high HIV incidences .
BACKGROUND	We describe the experience of recruiting and retaining volunteers in the first HIV vaccine trial ( HIVIS03 ) in Tanzania .
METHODS	In this trial enrolled volunteers from amongst Police Officers ( POs ) in Dar es Salaam were primed with HIV-1 DNA vaccine at months 0 , 1 and 3 ; and boosted with HIV-1 MVA vaccine at months 9 and 21 .
METHODS	A stepwise education provision/sensitization approach was employed to eventual recruitment .
METHODS	Having identified a `` core '' group of POs keen on HIV prevention activities , those interested to participate in the vaccine trial were invited for a first screening session that comprised of provision of detailed study information and medical evaluation .
METHODS	In the second screening session results of the initial assessment were provided and those eligible were assessed for willingness to participate ( WTP ) .
METHODS	Those willing were consented and eventually randomized into the trial having met the eligibility criteria .
METHODS	Voluntary participation was emphasized throughout .
RESULTS	Out of 408 POs who formed the core group , 364 ( 89.0 % ) attended the educational sessions .
RESULTS	263 out of 364 ( 72.2 % ) indicated willingness to participate in the HIV vaccine trial .
RESULTS	98 % of those indicating WTP attended the pre-screening workshops .
RESULTS	220 ( 85.0 % ) indicated willingness to undergo first screening and 177 POs attended for initial screenings , of whom 162 ( 91.5 % ) underwent both clinical and laboratory screenings .
RESULTS	119 volunteers ( 73.5 % ) were eligible for the study .
RESULTS	79 were randomized into the trial , while 19 did not turn up , the major reason being partner/family advice .
RESULTS	60 volunteers including 15 females were recruited during a one-year period .
RESULTS	All participated in the planned progress updates workshops .
RESULTS	Retention into the schedule was : 98 % for the 3 DNA/placebo vaccinations , while it was 83 % and 73 % for the first and second MVA/placebo vaccinations respectively .
CONCLUSIONS	In this first HIV vaccine trial in Tanzania , we successfully recruited the volunteers and there was no significant loss to follow up .
CONCLUSIONS	Close contact and updates on study progress facilitated the observed retention rates .
BACKGROUND	ISRCTN90053831 ISRNCT01132976 and ATMR2009040001075080 .

###25223482
BACKGROUND	The GeparQuinto study showed that adding bevacizumab to 24 weeks of anthracycline-taxane-based neoadjuvant chemotherapy increases pathological complete response ( pCR ) rates overall and specifically in patients with triple-negative breast cancer ( TNBC ) .
BACKGROUND	No difference in pCR rate was observed for adding everolimus to paclitaxel in nonearly responding patients .
BACKGROUND	Here , we present disease-free ( DFS ) and overall survival ( OS ) analyses .
METHODS	Patients ( n = 1948 ) with HER2-negative tumors of a median tumor size of 4 cm were randomly assigned to neoadjuvant treatment with epirubicin/cyclophosphamide followed by docetaxel ( EC-T ) with or without eight infusions of bevacizumab every 3 weeks before surgery .
METHODS	Patients without clinical response to EC Bevacizumab were randomized to 12 weekly cycles paclitaxel with or without everolimus 5 mg/day .
METHODS	To detect a hazard ratio ( HR ) of 0.75 ( = 0.05 , = 0.8 ) 379 events had to be observed in the bevacizumab arms .
RESULTS	With a median follow-up of 3.8 years , 3-year DFS was 80.8 % and 3-year OS was 89.7 % .
RESULTS	Outcome was not different for patients receiving bevacizumab ( HR 1.03 ; P = 0.784 for DFS and HR 0.974 ; P = 0.842 for OS ) compared with patients receiving chemotherapy alone .
RESULTS	Patients with TNBC similarly showed no improvement in DFS ( HR = 0.99 ; P = 0.941 ) and OS ( HR = 1.02 ; P = 0.891 ) when treated with bevacizumab .
RESULTS	No other predefined subgroup ( HR + / HER2 - ; locally advanced ( cT4 or cN3 ) or not ; cT1-3 or cT4 ; pCR or not ) showed a significant benefit .
RESULTS	No difference in DFS ( HR 0.997 ; P = 0.987 ) and OS ( HR 1.11 ; P = 0.658 ) was observed for nonearly responding patients receiving paclitaxel with or without everolimus overall as well as in subgroups .
CONCLUSIONS	Long-term results , in opposite to the results of pCR , do not support the neoadjuvant use of bevacizumab in addition to an anthracycline-taxane-based chemotherapy or everolimus in addition to paclitaxel for nonearly responding patients .
BACKGROUND	NCT 00567554 , www.clinicaltrials.gov .

###24583931
BACKGROUND	It is still inconclusive whether chronic hepatitis B ( CHB ) patients with persistently normal alanine aminotransferase ( PNALT ) should receive nucleoside/nucleotide analogues .
BACKGROUND	This study is to evaluate the efficacy of entecavir in improving liver histology in CHB patients with PNALT .
METHODS	In this prospective randomized , double-blind , placebo-controlled study , 380 CHB patients with PNALT were screened , 82 patients received biopsy and 43 patients met the HBV DNA and histology criteria and were randomly assigned to either an entecavir or placebo group for 52 weeks , with 22 and 21 in each group , respectively .
METHODS	The primary objective was to evaluate histological improvement .
METHODS	The secondary objective is to evaluate virological efficacy .
RESULTS	A total of eight ( 38.1 % ) patients in the entecavir group and eight ( 44.4 % ) in the placebo group ( P = 0.752 ) showed histological improvement .
RESULTS	The decrease in total Knodell scores ( sd ) was 1.3 1.9 in the entecavir group and 1.5 2.2 in the placebo group ( P = 0.803 ) .
RESULTS	The subjects with undetectable HBV DNA at week 52 were 16/21 ( 76.2 % ) in the entecavir group and 0/18 ( 0 % ) in the placebo group ( P < 0.001 ) .
RESULTS	The mean HBV DNA reduction from baseline to week 52 was 4.73 0.83 in the entecavir and 0.25 0.81 in the placebo group ( P < 0.001 ) .
CONCLUSIONS	CHB patients with PNALT receiving entecavir therapy for one year achieved virological efficacy , but not histological benefit .
CONCLUSIONS	ClinicalTrials.gov number NCT01833611 .

###25194782
OBJECTIVE	The aims of this study were to evaluate correlates and predictors of life functioning and quality of life in bipolar disorder during a comparative effectiveness trial of moderate doses of lithium .
METHODS	In the Lithium treatment moderate-dose use study ( LiTMUS ) , 283 symptomatic outpatients with bipolar disorder type I or II were randomized to receive lithium plus `` optimal personalized treatment ( OPT ) '' , or OPT alone .
METHODS	Participants were assessed using structured diagnostic interviews , clinician-rated blinded assessments , and questionnaires .
METHODS	We employ linear mixed effects models to test the effect of treatment overall and adjunct lithium specifically on quality of life or functioning .
METHODS	Similar models are used to examine the association of baseline demographics and clinical features with quality of life and life functioning .
RESULTS	Quality of life and impaired functioning at baseline were associated with lower income , higher depressive severity , and more psychiatric comorbid conditions .
RESULTS	Over 6 months , patients in both treatment groups improved in quality of life and life functioning ( p-Values < 0.0001 ) ; without a statistically significant difference between the two treatment groups ( p-Values > 0.05 ) .
RESULTS	Within the lithium group , improvement in quality of life and functioning was not associated with concurrent lithium levels at week 12 or week 24 ( p-Values > 0.05 ) .
RESULTS	Lower baseline depressive severity and younger age of onset predicted less improvement in functioning over 6 months .
CONCLUSIONS	Optimized care for bipolar disorder improves overall quality of life and life functioning , with no additional benefit from adjunct moderate doses of lithium .
CONCLUSIONS	Illness burden and psychosocial stressors were associated with worse quality of life and lower functioning in individuals with bipolar disorder .

###24460748
OBJECTIVE	To assess the accuracy of guided surgery ( mucosa and bone-supported ) compared to mental navigation or the use of a surgical template , in fully edentulous jaws , in a randomized controlled study .
METHODS	Fifty-nine patients ( 72 jaws ) , requiring four to six implants ( maxilla or mandible ) , were consecutively recruited and randomly assigned to one of the following treatment groups ; guidance via Materialise Universal ( ) / mucosa , Materialise Universal ( ) / bone , Facilitate/mucosa , Facilitate/bone , or mental navigation or a pilot-drill template .
METHODS	The precision was assessed by matching the planning computed tomography ( CT ) with a post-operative cone beam CT. .
RESULTS	A significant lower mean deviation at the entry point ( 1.4 mm , range : 0.3-3 .7 ) , at the apex ( 1.6 mm , range : 0.2-3 .7 ) and angular deviation ( 3.0 , range : 0.2-16 ) was observed for the guiding systems when compared to mental navigation ( 2.7 mm , range : 0.3-8 .3 ; 2.9 mm , range : 0.5-7 .4 and 9.9 , range : 1.5-27 .8 ) and to the surgical template group ( 3.0 mm , range : 0.6-6 .6 ; 3.4 mm , range : 0.3-7 .5 and 8.4 , range : 0.6-21 .3 ) .
RESULTS	Differences between bone and mucosa support or type of guidance were negligible .
RESULTS	Jaw and implant location ( posterior-anterior , left-right ) , however , had a significant influence on the accuracy when guided .
CONCLUSIONS	Based on these findings , guided implant placement appears to offer clear accuracy benefits .

###24275013
BACKGROUND	In this study , the impact of quetiapine fumarate extended release ( QXR ) and escitalopram ( ESC ) on HPA axis activity was investigated in depressed patients in relationship to antidepressant efficacy .
METHODS	In a randomized , open-label 5-week trial 60 inpatients suffering from major depression ( DSM-IV criteria ) were treated for 5 weeks with either QXR ( 300 mg/day ) or ESC ( 10mg/day ) .
METHODS	The dexamethasone/CRH ( DEX/CRH ) test was performed before treatment , after 1 , and after 5 weeks of treatment .
METHODS	Cortisol ( COR ) AUC values were used to assess HPA axis function .
METHODS	The Hamilton Depression Rating Scale was used weekly to estimate antidepressant efficacy .
RESULTS	QXR and ESC showed comparable antidepressant effects but strongly differed in their impact on HPA axis activity .
RESULTS	In the QXR group , a marked inhibition of COR AUC levels was observed which was most pronounced after one week of treatment but showed a partial re-increase after 5 weeks of treatment .
RESULTS	In contrast , ESC transiently stimulated COR AUC values ( week 1 ) whereas COR AUC levels at week 0 and week 5 were comparable .
RESULTS	COR improvement at week 1 ( defined as COR peak value reduction between DEX/CRH test 1 and 2 ) was significantly associated with better clinical outcome .
CONCLUSIONS	Apparently , different effects on HPA axis activity reflect distinct pharmacoendocrinological properties of psychotropic drugs .

###24744188
BACKGROUND	Several studies indicate that increasing the alimentary limb length in gastric bypass surgery produces only a minor improvement of excess BMI loss .
BACKGROUND	Few studies have addressed the efficacy of increasing the length of the pancreatico-biliary limb .
METHODS	Here , we present a prospective randomized study of 187 consecutive laparoscopic Roux-Y gastric bypass operations operated over 2 years ( 2004-2005 ) in Iceland .
METHODS	The patients were operated with a gastric bypass with either a 2-m biliopancreatic ( BP ) - limb and a 60-cm alimentary ( A ) - limb ( n = 93 ) or with a 150-cm A-limb and a 60-cm BP-limb ( n = 94 ) .
RESULTS	Preoperative median BMI was 44.1 ( 38-70 ) , median age 35.5 ( 17-74 ) years , and 85 % of the patients were female .
RESULTS	Follow-up rate after 5 years was 85 % .
RESULTS	Eighteen months following surgery , the weight loss was significantly higher in the BP-limb group ( p < 0.001 ) , and this difference remained 7 years after surgery .
RESULTS	Weight regain occurred in both groups , and 7 years after surgery , excess BMI loss ( EBMIL ) was 78.4 % in the BP-limb group compared to 67.1 % in the A-limb group ( p < 0.001 ) .
RESULTS	Most patients ( 78 % ) needed supplementation adjustment ( iron , vitamin D and calcium ) during the study period , significantly more often in the BP-limb group compared to the A-limb group ( p < 0.001 ) .
RESULTS	Patients in the BP-limb group had more frequent stools than patients in the A-limb group ; otherwise , gastro-intestinal symptoms rating scoring were comparable .
RESULTS	Complication rate was similar .
CONCLUSIONS	Gastric bypass with a 2-m BP-limb gives better weight loss than gastric bypass with a 60-cm BP-limb and a 150-cm A-limb .
CONCLUSIONS	Metabolic follow-up is of utmost importance , as most patients needed repeated adjustments of their supplementation .

###24885388
BACKGROUND	The Diabetes Prevention Program ( DPP ) is highly effective in promoting weight loss in overweight and obese individuals .
BACKGROUND	However , one-on-one DPP sessions are costly .
BACKGROUND	As a cost-saving alternative , a group version of the DPP , called Group Lifestyle Balance program ( GLB ) , has been developed but has been shown to be less effective .
BACKGROUND	The aim of this two-arm parallel randomized controlled trial is to increase the effectiveness of the GLB by integrating habit formation techniques , namely if-then plans and their mental practice , into the program .
METHODS	A total of 154 participants will be randomized to a standard or enriched GLB program .
METHODS	For the enriched GLB program , if-then plans and their mental practice will be integrated into the standard GLB program .
METHODS	Participants will be overweight or obese men and women ( BMI of 28 to 45kg/m2 , waist circumference88 for women , 102 for men , 18 to 75years of age ) who do less than 200minutes of self-reported moderate or vigorous exercise per week .
METHODS	Measures will be completed at baseline , 3months , post-intervention ( 12months ) , and 12months post-intervention ( 24months ) .
METHODS	The primary outcome measure is weight loss at 3 , 12 , and 24months .
METHODS	Secondary outcomes include percent reaching weight loss goal , physical activity at 3 , 12 , and 24months , and weight-related risk factors ( waist circumference , hemoglobin A1c , systolic/diastolic blood pressure , total cholesterol/HDL ratio ) .
METHODS	Standardized training of the life-style coaches , use of standardized manuals , and audio taping and reviewing of the sessions will ensure intervention fidelity .
CONCLUSIONS	The study will provide evidence-based data on the effectiveness of an enhanced GLB intervention in promoting weight loss and in reducing weight-related risk factors for chronic health problems .
CONCLUSIONS	Ethical clearance has been received from the Research Ethics and Compliance Board of the Faculty of Medicine Research and Graduate Studies Office at McGill University ( Montreal , Canada ) .
BACKGROUND	ClinicalTrials.gov Identifier : NCT02008435 .
BACKGROUND	Registered 6 December 2013 .

###24351013
BACKGROUND	Endogenous pain modulation ( EPM ) is central to the processing of sensory information .
BACKGROUND	Visceral and somatic EPM are abnormal in irritable bowel syndrome , but have not been studied in functional dyspepsia ( FD ) .
METHODS	Visceral EPM was assessed in 34 FD patients and 42 healthy controls .
METHODS	Gastric pain was induced with oral capsaicin and EPM was studied by adding heterotopic thermal foot stimulation or distraction by STROOP test .
METHODS	Somatic EPM was assessed using foot heat stimulation with heterotopic hand electrical stimulation .
RESULTS	Endogenous pain modulation by distraction reduced mean gastric pain by 11.9 on the 0-100 visual analog scale ( 95 % CI : 3.8-20 .1 ) in controls ( p = 0.006 ) and by 2.0 ( -6.18 to 10.44 ) in FD ( p = 0.6 ) , with greater EPM in controls than in FD ( difference -13.3 [ -26.1 to -0.5 ] ; p = 0.04 ) .
RESULTS	Endogenous pain modulation by heterotopic foot stimulation reduced gastric pain by 6.5 ( -0.7 to 13.6 ) in controls ( p = 0.07 ) and by 7.1 ( -2.29 to 16.47 ) in FD ( p = 0.1 ) , with no significant difference in EPM between controls and FD ( -2.0 [ -14.5 to 10.5 ] ; p = 0.75 ) .
RESULTS	In patients with prominent FD pain , greater pain correlated with decreased visceral EPM by distraction ( r = 0.51 , p = 0.04 ) .
RESULTS	Somatic EPM by heterotopic stimulation significantly decreased foot pain in controls ( p = 0.004 ) , but not in FD ( p = 0.80 ) .
CONCLUSIONS	In FD , visceral pain modulation by distraction was dysfunctional compared to controls .
CONCLUSIONS	Somatic pain modulation was also decreased in FD .
CONCLUSIONS	These data and the correlation of abnormal pain modulation by distraction with clinical pain in pain-predominant FD suggest a potential pathophysiological significance of abnormal pain modulation in FD .

###24524293
BACKGROUND	To investigate the effect of an early childhood obesity prevention intervention , incorporating a parent modelling component , on fathers ' obesity risk-related behaviours .
METHODS	Cluster randomized-controlled trial in the setting of pre-existing first-time parents groups organised by Maternal and Child Health Nurses in Victoria , Australia .
METHODS	Participants were 460 first-time fathers mean age = 34.2 ( s.d. 4.90 ) years .
METHODS	Dietary pattern scores of fathers were derived using principal component analysis , total physical activity and total television viewing time were assessed at baseline ( infant aged three to four months ) and after 15 months .
RESULTS	No significant beneficial intervention effect was observed on fathers ' dietary pattern scores , total physical activity or total television viewing time .
CONCLUSIONS	Despite a strong focus on parent modelling ( targeting parents own diet , physical activity and television viewing behaviours ) , and beneficial impact on mothers ' obesity risk behaviours , this intervention , with mothers as the point of contact , had no effect on fathers ' obesity risk-related behaviours .
CONCLUSIONS	Based on the established links between children 's obesity risk-related behaviors and that of their fathers , a need exists for research testing the effectiveness of interventions with a stronger engagement of fathers .

###24929902
OBJECTIVE	The time course of the contingent negative variation ( CNV ) as well as beta-power are known to entrain to regular task rhythms , revealing implicit anticipatory timing .
OBJECTIVE	Thus far , these effects have been established for manual responses only .
OBJECTIVE	Here we investigate entrainment preceding leg movements .
METHODS	High-density EEG was recorded while participants were standing and responded to series of rhythmically presented arrow stimuli by making brisk leg movements .
METHODS	The standard interval between reaction stimuli differed between series and was either 1500 or 2000 ms. Each series ' final interval was 1750 ms , representing a timing perturbation .
RESULTS	Entrainment was manifested in the CNV time course , where the maximum amplitude was reached just before the next stimulus was presented .
RESULTS	The pattern of beta - ( de ) synchronization similarly entrained to the task rhythm .
RESULTS	CNV scalp topographies suggested effector dependency of the entrainment-induced CNV .
CONCLUSIONS	We demonstrate that lower limb motor control , like upper limb control , readily entrains to a regular task rhythm .
CONCLUSIONS	These findings are relevant to Parkinson 's disease ( PD ) , where problems are found in rhythm processing and temporal preparation .
CONCLUSIONS	Investigation of the neural correlates of leg movement entrainment is important in view of presumed relations between entrainment and cueing of gait in PD .

###24953206
BACKGROUND	Mixed cryoglobulinaemia is strongly related to hepatitis C virus infection .
BACKGROUND	Treatment with peg-interferon and ribavirin has been indicated as first-line therapy for mild/moderate hepatitis C virus-related mixed cryoglobulinaemia .
OBJECTIVE	To evaluate the safety and efficacy of triple boceprevir-based antiviral therapy in patients with or without mixed cryoglobulinaemia previously treated with peg-interferon and ribavirin , and with advanced liver disease .
METHODS	Thirty-five hepatitis C virus-positive patients ( 17 with asymptomatic mixed cryoglobulinaemia , 5 with symptomatic mixed cryoglobulinaemia , and 11 without mixed cryoglobulinaemia ) were treated with triple boceprevir-based antiviral therapy .
RESULTS	In 19/22 cryoglobulinaemic subjects ( 86 % ) , the addition of boceprevir induced cryocrit disappearance .
RESULTS	Cryocrit behaviour was related to virological response , with improvement of symptoms upon undetectable viraemia and reappearance after virological breakthrough .
RESULTS	The rate of sustained virological response was lower in cryoglobulinaemic patients than in patients without mixed cryoglobulinaemia ( 23.8 % vs 70 % respectively , p = 0.01 ) .
CONCLUSIONS	Boceprevir-based therapy was safe and effective in cryoglobulinaemic patients .
CONCLUSIONS	The correlation between direct inhibition of hepatitis C virus replication and clinical improvement in mixed cryoglobulinaemic patients is definitive proof of the key pathogenetic role played by viral replication .
CONCLUSIONS	Further studies are needed to confirm and clarify the reduced virological response in patients with mixed cryoglobulinaemia .

###25138183
OBJECTIVE	Bivalirudin has emerged as a meaningful alternative to heparin in patients undergoing percutaneous coronary intervention ( PCI ) .
OBJECTIVE	To date , it is unclear whether bivalirudin has advantages in patients undergoing rotational atherectomy ( RA ) .
RESULTS	The current subgroup analysis of the ROTAXUS trial compared patients receiving bivalirudin ( n = 129 ) to those receiving unfractionated heparin ( UFH ) ( n = 111 ) .
RESULTS	Efficacy was assessed by the frequency of periprocedural myocardial infarction ( MI ) and safety by the frequency of major access-site bleeding ( ASB ) .
RESULTS	Baseline characteristics were similar .
RESULTS	Periprocedural MI occurred less frequently in the bivalirudin group ( 22 % vs. 37.5 % , p = 0.02 ) , while ASB did not differ significantly ( 2.3 % vs. 5.5 % , p = 0.20 ) .
RESULTS	This effect was larger in the RA group , where bivalirudin significantly reduced periprocedural MI ( 15.7 % vs. 38.7 % , p = 0.01 ) with a trend towards reduced major ASB ( 2.9 % vs. 10.2 % , p = 0.09 ) .
RESULTS	In the control group without RA , bivalirudin was not superior to UFH regarding periprocedural MI ( 28.6 % vs. 36.6 % , p = 0.42 ) and major ASB ( 1.7 % vs. 1.7 % , p = 0.99 ) .
CONCLUSIONS	This analysis suggests a differential benefit of bivalirudin in patients treated with RA .
CONCLUSIONS	Patients receiving bivalirudin during RA showed significantly less periprocedural MI and fewer ASB compared to patients treated with UFH .

###24377413
OBJECTIVE	Little is known on the long-term effects of obesity intervention programs in preschool-aged children .
OBJECTIVE	We compared the long-term effects of a multidisciplinary treatment program with a usual-care program in seventy-five 3 - to 5-year-old overweight or obese children who had participated in a randomized controlled clinical trial .
METHODS	A follow-up study collecting data at 18 and 36 months after starting both programs .
METHODS	The multidisciplinary program consisted of diet counseling , exercise sessions teaching motor skills and focusing on an active lifestyle , and psychoeducation for parents .
METHODS	Outcome measures were changes in anthropometry and body composition , determined by bioelectrical impedance analysis and ultrasound .
RESULTS	At the end of the 16-week treatment program , the multidisciplinary intervention showed a greater decrease in body mass index z score ( BMI-z ) ( mean ( SD ) 0.2 ( 0.1 ) ) and waist circumference z score ( WC-z ) ( mean ( SD ) 0.3 ( 0.1 ) ) , than usual-care .
RESULTS	During the 36-month follow-up , a significant overall treatment effect of the multidisciplinary intervention program was demonstrated on BMI-z ( 0.28 , 95 % CI 0.03-0 .54 ) and abdominal subcutaneous fat ( SCF ) ( 0.23 , 95 % CI 0.01-0 .45 ) , compared with the usual-care program .
CONCLUSIONS	A multidisciplinary intervention program in 3 - to 5-year-old overweight and obese children shows greater long-term effects on reductions in BMI-z and SCF , compared with a usual-care program .

###24373547
BACKGROUND	Severe neonatal jaundice and its progression to kernicterus is a leading cause of death and disability among newborns in poorly-resourced countries , particularly in sub-Saharan Africa .
BACKGROUND	The standard treatment for jaundice using conventional phototherapy ( CPT ) with electric artificial blue light sources is often hampered by the lack of ( functional ) CPT devices due either to financial constraints or erratic electrical power .
BACKGROUND	In an attempt to make phototherapy ( PT ) more readily available for the treatment of pathologic jaundice in underserved tropical regions , we set out to test the hypothesis that filtered sunlight phototherapy ( FS-PT ) , in which potentially harmful ultraviolet and infrared rays are appropriately screened , will be as efficacious as CPT .
METHODS	This prospective , non-blinded randomized controlled non-inferiority trial seeks to enroll infants with elevated total serum/plasma bilirubin ( TSB , defined as 3 mg/dl below the level recommended by the American Academy of Pediatrics for high-risk infants requiring PT ) who will be randomly and equally assigned to receive FS-PT or CPT for a total of 616 days at an inner-city maternity hospital in Lagos , Nigeria .
METHODS	Two FS-PT canopies with pre-tested films will be used .
METHODS	One canopy with a film that transmits roughly 33 % blue light ( wavelength range : 400 to 520 nm ) will be used during sunny periods of a day .
METHODS	Another canopy with a film that transmits about 79 % blue light will be used during overcast periods of the day .
METHODS	The infants will be moved from one canopy to the other as needed during the day with the goal of keeping the blue light irradiance level above 8 W/cm/nm .
METHODS	FS-PT will be as efficacious as CPT in reducing the rate of rise in bilirubin levels .
METHODS	Secondary outcome : The number of infants requiring exchange transfusion under FS-PT will not be more than those under CPT .
CONCLUSIONS	This novel study offers the prospect of an effective treatment for infants at risk of severe neonatal jaundice and avoidable exchange transfusion in poorly-resourced settings without access to ( reliable ) CPT in the tropics .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01434810 .

###24880749
BACKGROUND	Preclinical studies suggest that lithium carbonate ( lithium ) can reduce precipitated cannabinoid withdrawal in rats by stimulating release of the neuropeptide oxytocin , while two open-label studies indicate lithium may ameliorate cannabis withdrawal symptoms in humans .
OBJECTIVE	This study was conducted to examine the efficacy and safety of lithium in the inpatient management of cannabis withdrawal and to determine whether lithium affects plasma oxytocin and the rate of elimination of plasma cannabinoids during abstinence .
METHODS	Treatment-seeking cannabis-dependent adults ( n = 38 ) were admitted for 8days to an inpatient withdrawal unit and randomized to either oral lithium ( 500mg ) or placebo given twice a day under double-blind randomized controlled trial ( RCT ) conditions .
METHODS	Primary outcomes included withdrawal severity [ cannabis withdrawal scale ( CWS ) ] , rates of detoxification completion , and adverse events .
METHODS	Plasma cannabinoids , plasma oxytocin and serum lithium levels were measured repeatedly over admission .
METHODS	Follow-up research interviews were conducted at 14 , 30 , and 90days postdischarge .
RESULTS	Lithium did not significantly affect total CWS scores relative to placebo , although it significantly reduced individual symptoms of `` loss of appetite , '' `` stomach aches , '' and `` nightmares/strange dreams . ''
RESULTS	No significant group differences were found in treatment retention or adverse events .
RESULTS	Lithium did not increase plasma oxytocin levels nor influence the rate of elimination of cannabinoids .
RESULTS	Both placebo - and lithium-treated participants showed reduced levels of cannabis use ( verified by urinalysis ) and improved health and psychosocial outcomes at 30 - and 90-day follow-up relative to pretreatment baselines .
CONCLUSIONS	Despite the strong rationale for the present study , the efficacy of lithium over placebo in the management of cannabis withdrawal was not demonstrated .

###25799402
OBJECTIVE	While vitamin D supplementation and exercise are recommended for prevention of falls for older people , results regarding these 2 factors are contradictory .
OBJECTIVE	To determine the effectiveness of targeted exercise training and vitamin D supplementation in reducing falls and injurious falls among older women .
METHODS	A 2-year randomized , double-blind , placebo-controlled vitamin D and open exercise trial conducted between April 2010 and March 2013 in Tampere , Finland .
METHODS	Participants were 409 home-dwelling women 70 to 80 years old .
METHODS	The main inclusion criteria were at least 1 fall during the previous year , no use of vitamin D supplements , and no contraindication to exercise .
METHODS	Four study groups , including placebo without exercise , vitamin D ( 800 IU/d ) without exercise , placebo and exercise , and vitamin D ( 800 IU/d ) and exercise .
METHODS	The primary outcome was monthly reported falls .
METHODS	Injurious falls and the number of fallers and injured fallers were reported as secondary outcomes .
METHODS	In addition , bone density , physical functioning ( muscle strength , balance , and mobility ) , and vitamin D metabolism were assessed .
RESULTS	Intent-to-treat analyses showed that neither vitamin D nor exercise reduced falls .
RESULTS	Fall rates per 100 person-years were 118.2 , 132.1 , 120.7 , and 113.1 in the placebo without exercise , vitamin D without exercise , placebo and exercise , and vitamin D and exercise study groups , respectively ; however , injurious fall rates were 13.2 , 12.9 , 6.5 , and 5.0 , respectively .
RESULTS	Hazard ratios for injured fallers were significantly lower among exercisers with vitamin D ( 0.38 ; 95 % CI , 0.17-0 .83 ) and without vitamin D ( 0.47 ; 95 % CI , 0.23-0 .99 ) .
RESULTS	Vitamin D maintained femoral neck bone mineral density and increased tibial trabecular density slightly .
RESULTS	However , only exercise improved muscle strength and balance .
RESULTS	Vitamin D did not enhance exercise effects on physical functioning .
CONCLUSIONS	The rate of injurious falls and injured fallers more than halved with strength and balance training in home-dwelling older women , while neither exercise nor vitamin D affected the rate of falls .
CONCLUSIONS	Exercise improved physical functioning .
CONCLUSIONS	Future research is needed to determine the role of vitamin D in the enhancement of strength , balance , and mobility .
BACKGROUND	clinicaltrials.gov Identifier : NCT00986466 .

###24428754
BACKGROUND	On-treatment platelet reactivity ( OTR ) is a predictor of clinical outcomes in patients receiving thienopyridine therapy .
OBJECTIVE	To assess whether point-of-care platelet reactivity testing can discriminate between patients who have and have not received a thienopyridine .
METHODS	This was an analysis of a randomized , multicenter , pharmacodynamic trial .
METHODS	Subjects with coronary artery disease treated with aspirin were randomly assigned to clopidogrel 75mg daily or prasugrel 10mg daily for 7days .
METHODS	Platelet reactivity assessment with the VerifyNow P2Y12 test was performed before study drug admistration and 24h after the final dose .
METHODS	Optimal cut-offs for a detectable drug effect were identified by the use of receiver operating characteristic curve analysis .
RESULTS	A total of 54 subjects were enrolled and completed the study .
RESULTS	The c-statistic for the identification of a thienopyridine effect was highly significant ( 0.93 , P < 0.001 ) , including for the clopidogrel and prasugrel groups considered separately ( P < 0.001 for both ) .
RESULTS	The optimal cut-off was < 213 P2Y12 reaction units ( PRU ) , which provided a sensitivity of 80 % and a specificity of 98 % .
RESULTS	This cut-off provided a sensitivity of 58 % and a specificity of 100 % for a clopidogrel effect , and a sensitivity of 100 % and specificity of 96 % for a prasugrel effect .
CONCLUSIONS	OTR of < 213PRU is highly specific for exposure to either clopidogrel or prasugrel .
CONCLUSIONS	This may be useful in the management of thienoypridine-treated patients who require surgery .
CONCLUSIONS	Furthermore , this diagnostic cut-off is similar to levels of OTR that have been associated with ischemic events in thienopyridine-treated patients , supporting the contention that a lack of drug effect is the mechanistic basis for the prognostic relationship between OTR and clinical outcomes .

###24766295
BACKGROUND	Rikkunshito , a standardized Japanese herbal medicine , is thought to accelerate gastric emptying and relieve dyspepsia , although no large-scale , randomized , placebo-controlled trials of rikkunshito have been conducted .
BACKGROUND	This study aimed to determine the efficacy and safety of rikkunshito for treating functional dyspepsia ( FD ) .
METHODS	FD patients received 2.5 g rikkunshito or placebo three times a day for 8 weeks in this multicenter , randomized , placebo-controlled , parallel-group trial .
METHODS	The primary end point was the proportion of responders at 8 weeks after starting test drug , determined by global patient assessment ( GPA ) .
METHODS	The improvement in four major dyspepsia symptoms severity scale was also evaluated .
METHODS	In addition , plasma ghrelin levels were investigated before and after treatment .
RESULTS	Two hundred forty-seven patients were randomly assigned .
RESULTS	In the eighth week , the rikkunshito group had more GPA responders ( 33.6 % ) than the placebo ( 23.8 % ) , although this did not reach statistical significance ( p = 0.09 ) .
RESULTS	Epigastric pain was significantly improved ( p = 0.04 ) and postprandial fullness tended to improve ( p = 0.06 ) in the rikkunshito group at week 8 .
RESULTS	Rikkunshito was relatively more effective among Helicobacter pylori-infected participants ( rikkunshito : 40.0 % vs placebo : 20.5 % , p = 0.07 ) , and seemed less effective among H. pylori-uninfected participants ( rikkunshito : 29.3 % vs placebo : 25.6 % , p = 0.72 ) .
RESULTS	Among H. pylori-positive individuals , acyl ghrelin levels were improved just in rikkunshito group .
RESULTS	There were no severe adverse events in both groups .
CONCLUSIONS	Administration of rikkunshito for 8 weeks reduced dyspepsia , particularly symptoms of epigastric pain and postprandial fullness .
CONCLUSIONS	( UMIN Clinical Trials Registry , Number UMIN000003954 ) .

###25268438
OBJECTIVE	There is debate about benefits of acupuncture for knee pain .
OBJECTIVE	To determine the efficacy of laser and needle acupuncture for chronic knee pain .
METHODS	Zelen-design clinical trial ( randomization occurred before informed consent ) , in Victoria , Australia ( February 2010-December 2012 ) .
METHODS	Community volunteers ( 282 patients aged 50 years with chronic knee pain ) were treated by family physician acupuncturists .
METHODS	No acupuncture ( control group , n = 71 ) and needle ( n = 70 ) , laser ( n = 71 ) , and sham laser ( n = 70 ) acupuncture .
METHODS	Treatments were delivered for 12 weeks .
METHODS	Participants and acupuncturists were blinded to laser and sham laser acupuncture .
METHODS	Control participants were unaware of the trial .
METHODS	Primary outcomes were average knee pain ( numeric rating scale , 0 [ no pain ] to 10 [ worst pain possible ] ; minimal clinically important difference [ MCID ] , 1.8 units ) and physical function ( Western Ontario and McMaster Universities Osteoarthritis Index , 0 [ no difficulty ] to 68 [ extreme difficulty ] ; MCID , 6 units ) at 12 weeks .
METHODS	Secondary outcomes included other pain and function measures , quality of life , global change , and 1-year follow-up .
METHODS	Analyses were by intention-to-treat using multiple imputation for missing outcome data .
RESULTS	At 12 weeks and 1 year , 26 ( 9 % ) and 50 ( 18 % ) participants were lost to follow-up , respectively .
RESULTS	Analyses showed neither needle nor laser acupuncture significantly improved pain ( mean difference ; -0.4 units ; 95 % CI , -1.2 to 0.4 , and -0.1 ; 95 % CI , -0.9 to 0.7 , respectively ) or function ( -1.7 ; 95 % CI , -6.1 to 2.6 , and 0.5 ; 95 % CI , -3.4 to 4.4 , respectively ) compared with sham at 12 weeks .
RESULTS	Compared with control , needle and laser acupuncture resulted in modest improvements in pain ( -1.1 ; 95 % CI , -1.8 to -0.4 , and -0.8 ; 95 % CI , -1.5 to -0.1 , respectively ) at 12 weeks , but not at 1 year .
RESULTS	Needle acupuncture resulted in modest improvement in function compared with control at 12 weeks ( -3.9 ; 95 % CI , -7.7 to -0.2 ) but was not significantly different from sham ( -1.7 ; 95 % CI , -6.1 to 2.6 ) and was not maintained at 1 year .
RESULTS	There were no differences for most secondary outcomes and no serious adverse events .
CONCLUSIONS	In patients older than 50 years with moderate or severe chronic knee pain , neither laser nor needle acupuncture conferred benefit over sham for pain or function .
CONCLUSIONS	Our findings do not support acupuncture for these patients .
BACKGROUND	anzctr.org.au Identifier : ACTRN12609001001280 .

###25668777
OBJECTIVE	To compare the reciprocal control of agonist and antagonist muscles in individuals with and without spinocerebellar ataxia ( SCA ) and to evaluate the effect of a 4-week leg cycling regimen on functional coordination and reciprocal control of agonist and antagonist muscles in patients with SCA .
METHODS	Randomized controlled trial with repeated measures .
METHODS	Research laboratory in a general hospital .
METHODS	Individuals with SCA ( n = 20 ) and without SCA ( n = 20 ) .
METHODS	A single 15-minute session of leg cycling and a 4-week cycling regimen .
METHODS	Individuals with SCA ( n = 20 ) and without SCA ( n = 20 ) underwent disynaptic reciprocal inhibition and D1 inhibition tests of the soleus muscles before and after a single 15-minute cycling session .
METHODS	Individuals with SCA were randomly assigned to either participate in 4 weeks of cycling training ( n = 10 ) or to receive no training ( n = 10 ) .
METHODS	The disynaptic reciprocal inhibition and D1 inhibition and International Cooperative Ataxia Rating Scale ( ICARS ) scores were evaluated in both groups after 4 weeks .
RESULTS	Individuals with SCA showed abnormally strong resting values of disynaptic reciprocal inhibition and D1 inhibition ( P < .001 ) and impaired inhibition modulation capacity after a single 15-minute session of cycling ( P < .001 ) .
RESULTS	The inhibition modulation capacity was restored ( P < .001 ) , and the ICARS scores improved significantly ( pre : 13.59.81 , post : 11.38.74 ; P = .046 ) after 4 weeks of cycling training .
CONCLUSIONS	A 4-week cycling regimen can normalize the modulation of reciprocal inhibition and functional performance in individuals with SCA .
CONCLUSIONS	These findings are applicable to the coordination training of patients .

###25909408
BACKGROUND	In 2011 , supported by data from two separate trauma centers , we implemented a protocol to administer tranexamic acid ( TXA ) in trauma patients with evidence of hyperfibrinolysis ( HF ) on admission .
BACKGROUND	The purpose of this study was to examine whether the use of TXA in patients with HF determined by admission rapid thrombelastography was associated with improved survival .
METHODS	Following institutional review board approval , we evaluated all trauma patients 16 years or older admitted between September 2009 and September 2013 .
METHODS	HF was defined as LY-30 of 3 % or greater .
METHODS	Patients with LY-30 less than 3.0 % were excluded .
METHODS	Patients were divided into those who received TXA ( TXA group ) and those who did not ( no-TXA group ) .
METHODS	After univariate analyses , a purposeful , logistic regression model was developed a priori to evaluate the impact of TXA on mortality ( controlling for age , sex , Injury Severity Score ( ISS ) , arrival physiology , and base deficit ) .
RESULTS	A total of 1,032 patients met study criteria .
RESULTS	Ninety-eight ( 10 % ) received TXA , and 934 ( 90 % ) did not .
RESULTS	TXA patients were older ( median age , 37 years vs. 32 years ) , were more severely injured ( median ISS , 29 vs. 14 ) , had a lower blood pressure ( median systolic blood pressure 103 mm Hg vs. 125 mm Hg ) , and were more likely to be in shock ( median , base excess , -5 mmol/dL vs. -2 mmol/dL ) , all p < 0.05 .
RESULTS	Twenty-three percent of the patients had a repeat thrombelastography within 6 hours ; 8.8 % of the TXA patients had LY-30 of 3 % or greater on repeat rapid thrombelastography ( vs. 10.1 % in the no-TXA group , p = 0.679 ) .
RESULTS	Unadjusted in-hospital mortality was higher in the TXA group ( 40 % vs. 17 % , p < 0.001 ) .
RESULTS	There were no differences in venous thromboembolism ( 3.3 % vs. 3.8 % ) .
RESULTS	Logistic regression failed to find a difference in in-hospital mortality among those receiving TXA ( odds ratio , 0.74 ; 95 % confidence interval , 0.38-1 .40 ; p 0.80 ) .
CONCLUSIONS	In the current study , the use of TXA was not associated with a reduction in mortality .
CONCLUSIONS	Further studies are needed to better define who will benefit from an administration of TXA .
METHODS	Therapeutic study , level IV .

###25962611
BACKGROUND	Successful external cephalic version ( ECV ) for breech presenting fetus reduces the need for Caesarean section ( CS ) .
BACKGROUND	We aimed to compare the success rate of ECV with either spinal anaesthesia ( SA ) or i.v. analgesia using remifentanil .
METHODS	In a double-phased , stratified randomized blinded controlled study we compared the success rates of ECV , performed under spinal anaesthesia ( SA ) , i.v. analgesia ( IVA ) using remifentanil or no anaesthetic interventions .
METHODS	In phase I , 189 patients were stratified by parity before randomization to ECV , performed by blinded operators , under SA using either hyperbaric bupivacaine 9 mg with fentanyl 15 g , i.v. remifentanil infusion 0.1 g kg min ( -1 ) , or Control ( no anaesthetic intervention ) .
METHODS	Operators performing ECV were blinded to the treatment allocation .
METHODS	In phase 2 , patients in the Control group in whom the initial ECV failed were further randomized to receive either SA ( n = 9 ) or IVA ( n = 9 ) for a re-attempt .
METHODS	The primary outcome was the incidence of successful ECV .
RESULTS	The success rate in Phase 1 was greatest using SA [ 52/63 ( 83 % ) ] , compared with IVA [ 40/63 ( 64 % ) ] and Control [ 40/63 ( 64 % ) ] , ( P = 0.027 ) .
RESULTS	Median [ IQR ] pain scores on a visual analogue scale ( range 0-100 ) , were 0 [ 0-0 ] with SA , 35 [ 0-60 ] with IVA and 50 [ 30-75 ] in the Control group ( P < 0.001 ) .
RESULTS	Median [ IQR ] VAS sedation scores were highest with IVA [ 75 ( 50-80 ) ] , followed by SA , [ 0 ( 0-50 ) ] and Control [ 0 ( 0-0 ) ] .
RESULTS	In phase 2 , 7/9 ( 78 % ) of ECV re-attempts were successful with SA , whereas all re-attempts using IVA failed ( P = 0.0007 ) .
RESULTS	The incidence of fetal bradycardia necessitating emergency CS within 30 min , was similar among groups ; 1.6 % ( 1/63 ) in the SA and IVA groups and 3.2 % ( 2/63 ) in the Control group .
CONCLUSIONS	SA increased the success rate and reduced pain for both primary and re-attempts of ECV , whereas IVA using remifentanil infusion only reduced the pain .
CONCLUSIONS	There was no significant increase in the incidence of fetal bradycardia or emergency CS , with ECV performed under anaesthetic interventions .
CONCLUSIONS	Relaxation of the abdominal muscles from SA appears to underlie the improved outcomes for ECV .

###24685996
BACKGROUND	As the population ages , it is increasingly important to test new models of care that improve life quality and decrease health costs .
BACKGROUND	This paper presents the rationale and design for a randomized clinical trial of a novel interdisciplinary program to reduce disability among low income older adults based on a previous pilot trial of the same design showing strong effect .
METHODS	The CAPABLE ( Community Aging in Place , Advancing Better Living for Elders ) trial is a randomized controlled trial in which low income older adults with self-care disability are assigned to one of two groups : an interdisciplinary team of a nurse , occupational therapist , and handyman to address both personal and environmental risk factors for disability based on participants ' functional goals , or an attention control of sedentary activities of choice .
METHODS	Both groups receive up to 10 home visits over 4 months .
RESULTS	The primary outcome is decreased disability in self-care ( ADL ) .
RESULTS	Secondary outcomes are sustained decrease in self care disability as well as improvement in instrumental ADLS , strength , balance , walking speed , and health care utilization .
RESULTS	Careful cost tracking and analysis using intervention data and claims data will enable direct measurement of the cost impact of the CAPABLE approach .
RESULTS	CAPABLE has the potential to leverage current health care spending in Medicaid waivers , Accountable Care Organizations and other capitated systems to save the health care system costs as well as improving low income older adults ' ability to age at home with improved life quality .

###25902655
OBJECTIVE	Our aim was to compare changes of vascular and metabolic parameters in patients with essential hypertension on treatment with combination of perindopril with either indapamide retard or hydrochlorothiazide .
METHODS	The study involved 40 patients who were randomly assigned to perindopril 5-10 mg/day in combination with indapamide retard ( P+I ) 1.5 mg/day ( n = 20 ) or with hydrochlorothiazide ( P+HT ) 25 mg/day ( n = 20 ) .
METHODS	Waist circumference , body mass index , blood lipids and glucose , endothelial function ( EF ) determined as the change of resistance index after inhalation of salbutamol , arterial stiffness measured as mean pulse wave velocity after sublingual trinitroglycerin ( PWVtng ) were evaluated at baseline and 6 months thereafter .
METHODS	Vascular responses were calculated from digital pulse waves registered using photoplethysmography .
RESULTS	Dynamics of BP after 6 months did not differ significantly between groups .
RESULTS	Treatment with combination of P+HT resulted in significant decrease of EF ( -24,3 % , p < 0,05 ) accompanied by negative changes of triglycerides ( +13,4 % , p < 0,05 ) and glucose levels ( +9,8 % , p < 0,05 ) , whereas combination of P+I did not affect endothelial function and was metabolically neutral .
RESULTS	PWVtng significantly decreases on both regiments of treatment with the trend in favor of P+I combination ( -13,4 % , p < 0,001 versus -9,8 % , p < 0,01 for P+I and P+HT combinations , respectively ) .
CONCLUSIONS	Thus , despite the similar BP reduction the combination of ACE-inhibitor -- perindopril with indapamide retard possesses more favorable vascular and metabolic effects compared to combination with hydrochlorothiazide that potentially may account for different prognosis of patients with arterial hypertension on long-term treatment .

###25303337
BACKGROUND	There is non-experimental evidence that paracetamol ( acetaminophen ) use may increase the risk of developing asthma .
BACKGROUND	However , numerous methodological issues need to be resolved before undertaking a randomized controlled trial to investigate this hypothesis .
OBJECTIVE	To establish the feasibility of a randomized controlled trial of liberal paracetamol as usually given by parents/guardians vs. a comparator ( restricted paracetamol in accordance with WHO guidelines , ibuprofen or placebo ) , and childhood asthma risk .
METHODS	Questionnaires were completed by parents/guardians of infants admitted to Wellington Hospital with bronchiolitis to assess views about comparator treatments .
METHODS	Subsequently , infants of parents/guardians who provided informed consent were randomized to restricted or liberal paracetamol use for 3 months with paracetamol use recorded .
RESULTS	Of 120 eligible participants , 72 ( 60 % ) parents/guardians completed the questionnaire .
RESULTS	Ibuprofen , restricted paracetamol and placebo were acceptable to 42 ( 58 % ) , 29 ( 40 % ) and 9 ( 12 % ) parents/guardians , respectively .
RESULTS	36 ( 30 % ) infants were randomized to restricted or liberal paracetamol .
RESULTS	Paracetamol use was greater for the liberal vs. restricted group for reported [ Hodges-Lehmann estimator of difference 0.94 mg/kg/day ( 95 % CI 0.2-3 .52 ) , P = 0.02 ] and measured use [ Hodges-Lehmann estimator of difference 2.11 mg/kg/day ( 95 % CI 0.9-4 .18 ) , P = 0.004 ] .
RESULTS	The median reported and measured use of paracetamol was 2.0-fold and 3.5-fold greater in the liberal vs. restricted group .
CONCLUSIONS	Although separation in paracetamol dosing is likely to be achieved with a liberal vs. restricted paracetamol regime , ibuprofen is the preferred comparator treatment in the proposed RCT of paracetamol use and risk of asthma in childhood .

###25311306
OBJECTIVE	In cancer research , outcome measures may co-vary .
OBJECTIVE	Treatment and treatment related impairment of health-related quality of life ( HRQoL ) may affect survival .
OBJECTIVE	When these effects are analyzed separately , bias may arise .
OBJECTIVE	Therefore , we investigated the combined effect of treatment and longitudinally measured HRQoL on survival .
METHODS	Patients with anaplastic oligodendrogliomas ( n = 288 ) who were randomized ( EORTC 26951 ) to radiotherapy ( RT ) alone or RT plus procarbazine , lomustine , and vincristine ( PCV ) chemotherapy were analyzed .
METHODS	HRQoL [ appetite loss ( AP ) ] was assessed with the EORTC QLQ-C30 .
METHODS	We compared survival results from different analysis strategies : Cox model with treatment only [ model 1 ( M1 ) ] or with treatment and time-dependent AP score [ model 2 ( M2 ) ] and the joint model combining longitudinal AP score and survival [ model 3 ( M3 ) ] .
RESULTS	The estimated hazard ratio ( HR ) for RT plus PCV was 0.76 ( 95 % CI 0.58-1 .00 ) for M1 , 0.72 ( 0.55-0 .96 ) for M2 , and 0.69 ( 0.52-0 .92 ) for M3 .
RESULTS	This corresponds to a lower risk of death of 24 % in M1 , 28 % in M2 , and 31 % in M3 , for patients treated with RT plus PCV chemotherapy .
RESULTS	AP resulted in an increased risk of death , with estimated HR of 1.06 ( 1.01-1 .12 ) for M2 and 1.13 ( 1.03-1 .23 ) for M3 : Every 10-point increase of AP resulted in a 13 % increased risk of death in M3 as compared to 6 % in M2 .
CONCLUSIONS	Part of the survival benefit of treatment with RT plus PCV chemotherapy can be masked by the negative effect that this treatment has on patients ' HRQoL .
CONCLUSIONS	In our study , up to 7 % of the theoretical treatment efficacy was lost when AP was not adjusted through joint modeling .

###24558998
BACKGROUND	Diabetes mellitus is a global epidemic affecting 346 million people in the world .
BACKGROUND	The glycemic control is the key for diabetes prevention and management .
BACKGROUND	Some proteins can stimulate insulin release and modulate glycemic response .
OBJECTIVE	To assess the effect of the consumption of different types of protein ( whey protein , soy protein and egg white ) on a second meal postprandial glycaemia in normal weight and normoglycemic subjects .
METHODS	Randomized crossover clinical trial .
METHODS	After an overnight fast of 12-hours , ten subjects attended the laboratory to drink one of the protein shakes ( whey , soy or egg white ) or the control drink .
METHODS	Thirty minutes later , the subjects consumed a glucose solution ( 25 g glucose ) .
METHODS	Glycemic response was monitored at times 0 ( before glucose solution ) and 15 , 30 , 45 , 60 , 90 and 120 min ( after glucose solution consumption ) .
METHODS	Incremental area under the glycemic curve ( iAUC ) was calculated by the trapezoidal method .
METHODS	Furthermore , glycemic response was assessed by a new method using iG equation .
RESULTS	Compared with control , whey and soy protein drinks reduced postprandial iAUC in 56.5 % ( p = 0.004 ) and 44.4 % ( p = 0.029 ) , respectively .
RESULTS	Whey protein was the only protein capable of avoiding great fluctuations and a peak in postprandial glycemia .
RESULTS	The assessment of glycemic response by iG equation showed positive correlation with iAUC ( Pearson 0.985 , p < 0.05 ) .
CONCLUSIONS	The consumption of whey and soy protein 30 minutes before a glucose load resulted in lower iAUC compared with control drink .
CONCLUSIONS	Whey protein maintained postprandial glycemia more stable .

###25046944
OBJECTIVE	To evaluate the efficacy and safety of Yigan Fupi Decoction ( YFD ) in the treatment of irritable bowel syndrome with diarrhea ( IBS-D ) patients .
METHODS	A randomized controlled clinical trail was carried out in patients with IBS-D .
METHODS	All patients were randomly assigned to the treatment group ( 58 cases , treated with YFD ) and the control group ( 58 cases , treated with Pinaverium Bromide Tablet ) .
METHODS	The treatment course was 4 weeks for all patients .
METHODS	The total effective rate , the stool property and state , the quality of life ( QOL ) , and TCM syndrome efficacy were assessed by IBS bowel symptom severity scale ( IBS-BSS ) , IBS defecation state questionnaire ( IBS-DSQ ) , IBS quality of life questionnaire ( IBS-QOL ) , and traditional Chinese medicine pattern curative effect scoring system ( TCM-PES ) before and after treatment .
RESULTS	There was no statistical difference in the total effective rate between the two groups ( 82.76 % vs. 77.59 % , P > 0.05 ) .
RESULTS	The treatment group was superior in the total IBS-BSS integral to the control group ( P < 0.05 ) .
RESULTS	The total effective rate of improving the stool property was better in the treatment group than in the control group ( 81.03 % vs. 72.41 % , P < 0.05 ) .
RESULTS	Besides , the number of days for emergent defecation among 10 days was less in the treatment group than in the control group ( P < 0.05 ) .
RESULTS	The improvement of the total IBS-QOL integral and the total integral of TCM syndrome were better in the treatment group than in the control group ( P < 0.01 ) .
RESULTS	The total effective rate of TCM-PES was better in the treatment group than in the control group ( 84.48 % vs. 70.69 % , P < 0.05 ) .
CONCLUSIONS	YFD was effective in the treatment of IBS-D patients of Gan-qi invading Pi syndrome , and could effectively relieve bowel symptoms , improve the stool property and the defecation frequency , elevate their QOL , and attenuate Gan-qi invading Pi syndrome with favorable safety and compliance .

###25339836
OBJECTIVE	To compare same-day whole-dose vs split-dose of 2-litre polyethylene glycol electrolyte lavage solution ( PEG-ELS ) plus bisacodyl for colon cleansing for morning colonoscopy .
METHODS	Consecutive adult patients undergoing morning colonoscopy were allocated into two groups i.e. , same-day whole-dose or split-dose of 2-litre PEG-ELS .
METHODS	Investigators and endoscopists were blinded to the allocation .
METHODS	All patients completed a questionnaire that was designed by Aronchick and colleagues to assess the tolerability of the bowel preparation regime used .
METHODS	In addition , patients answered an ordinal five-value Likert scale question on comfort level during bowel preparation .
METHODS	Endoscopists graded the quality of bowel preparation using the Boston bowel preparation scale ( BBPS ) .
METHODS	In addition , endoscopists gave an overall grading of the quality of bowel preparation .
METHODS	Cecal intubation time , withdrawal time , total colonoscopy time , adenoma detection rate and number of adenomas detected for each patient were recorded .
METHODS	Sample size was calculated using an online calculator for binary outcome non-inferiority trial .
METHODS	Analyses was based upon intent-to-treat .
METHODS	Significance was assumed at P-value < 0.05 .
RESULTS	Data for 295 patients were analysed .
RESULTS	Mean age was 62.0 14.4 years old and consisted of 50.2 % male .
RESULTS	There were 143 and 152 patients in the split-dose and whole-dose group , respectively .
RESULTS	Split-dose was as good as whole-dose for quality of bowel preparation .
RESULTS	The total BBPS score was as good in the split-dose group compared to the whole-dose group [ 6 ( 6-8 ) vs 6 ( 6-7 ) , P = 0.038 ] .
RESULTS	There was no difference in cecal intubation rate , cecal intubation time , withdrawal time , total colonoscopy time and adenoma detection rate .
RESULTS	Median number of adenoma detected was marginally higher in the split-dose group [ 2 ( 1-3 ) vs 1 ( 1-2 ) , P = 0.010 ] .
RESULTS	Patients in the whole-dose group had more nausea ( 37.5 % vs 25.2 % , P = 0.023 ) and vomiting ( 16.4 % vs 8.4 % , P = 0.037 ) , and were less likely to complete the bowel preparation ( 94.1 % vs 99.3 % , P = 0.020 ) .
RESULTS	Patients in the split-dose group were less likely to refuse the same bowel preparation regime ( 6.3 % vs 13.8 % , P = 0.033 ) and less likely to want to try another bowel preparation regime ( 53.8 % vs 78.9 % , P < 0.001 ) .
CONCLUSIONS	Splitting reduced-volume PEG-ELS for morning colonoscopy is as effective as taking the whole dose on the same morning but is better tolerated and preferred by patients .

###24315409
OBJECTIVE	The probability of developing osteoporosis decreases with an adequate supply of vitamin D , a balanced diet , and increased physical activity .
OBJECTIVE	In this study , we evaluated whether an educational intervention improves osteoporosis-related behavior in perimenopausal women from rural areas .
METHODS	A randomized experimental evaluation was performed of an educational intervention .
METHODS	The variables were physical activity , calcium intake and sun exposure in women from rural areas aged 45-54 years ( n = 216 ) at time 0 and 12 months after the educational intervention .
METHODS	In the control group ( n = 106 ) , the information was sent by surface mail ( month 0 ) .
METHODS	In the intervention group ( n = 110 ) , two interactive workshops were given ( month 0 ) .
METHODS	The topic of the workshops and the information sent by surface mail was healthy habits for osteoporosis prevention .
RESULTS	After 12 months , the intervention group , but not the control group , had increased their physical activity ( p = 0.006 ) , sun exposure ( p = 0.029 ) , and calcium intake ( 53 % to 64 % ) .
CONCLUSIONS	A simple educational intervention in perimenopausal women from rural areas improved healthy habits for osteoporosis prevention .

###25079064
OBJECTIVE	To investigate the impact of antiangiogenic monotherapy and photodynamic therapy ( PDT ) as add-on strategy on retinal morphology , and to analyse prognostic biomarkers for visual outcome and retreatment frequency in neovascular age-related macular degeneration ( nAMD ) .
METHODS	255 patients participating in the MONT BLANC study were evaluated .
METHODS	Patients were randomised to receive as-needed ranibizumab monotherapy or combination therapy ( verteporfin PDT and ranibizumab ) .
METHODS	Outcome measures included visual acuity ( VA ) , retinal morphology assessed by optical coherence tomography and retreatment frequency .
RESULTS	The proportion of scans showing intraretinal cysts ( IRC ) or subretinal fluid ( SRF ) decreased more intensively in the combination than in the monotherapy group .
RESULTS	Pigment epithelial detachments ( PED ) decreased significantly only in the combination group .
RESULTS	Patients with IRC presented the lowest initial VA , and IRC had the strongest negative predictive value for functional improvement in both groups .
RESULTS	SRF showed a predictive value for a higher number of ranibizumab injections ( combination , +0.9 ; monotherapy , +0.8 ) and a higher number of PDT treatments in the combination group ( +0.3 ) .
RESULTS	PED was associated with a higher number of ranibizumab injections only in the monotherapy group ( +1.2 ) .
CONCLUSIONS	Combination and monotherapy showed a distinct response pattern for morphological parameters in nAMD .
CONCLUSIONS	IRC was the only relevant prognostic parameter for functional outcome .
BACKGROUND	NCT00433017 .

###24684245
BACKGROUND	Thyroid hormones are required for normal brain maturation , and neonatal plasma thyroid hormone concentrations are low in infants less than 28 weeks gestation .
BACKGROUND	It is not known whether treatment of such infants with thyroid hormone improves neurodevelopmental outcome .
METHODS	At three years corrected age , mental , motor , and neurological development was assessed in infants born at less than 28 weeks gestational age who had participated in a phase 1 trial of differing doses and modes of administration of thyroid hormone .
METHODS	The trial 's endpoints were thyroid hormone ( thyroxine , T4 ) and thyotropin plasma concentrations in eight study arms : six treated with T4 [ 4 , 8 , and 16 g / ( kg day ) ] , bolus or continuous ] , one treated with iodine only , and one treated with placebo .
METHODS	Follow-up at three years was not part of the original study goals .
METHODS	Developmental index scores , rates of cerebral palsy ( CP ) , and rates of adverse outcome ( death or moderate to severe delay in development and/or disabling CP ) were compared between the eight study groups and between groups combined by dosage level , and between infants with and without T4 supplementation .
RESULTS	Of 166 randomized infants , 32 ( 19 % ) died in the neonatal period .
RESULTS	Of the 134 survivors , follow-up results were available for 89 children ( 66 % ) .
RESULTS	Mental and motor development and rates of cerebral palsy did not differ in any of the comparisons made .
CONCLUSIONS	In this study , no differences in neurodevelopment were found in relation to thyroid hormone treatment , but power was insufficient to detect any but very large differences .

###25073269
OBJECTIVE	To compare the effect of intravenous 20 % mannitol or dexamethasone ( DM ) on low back and leg pain after minimally invasive transforaminal lumbar interbody fusion ( MI-TLIF ) .
METHODS	Between October 2012 and September 2013 , 100 patients with degenerative lumbar diseases underwent MI-TLIF and percutaneous pedicle screw fixation .
METHODS	All patients were randomly divided into 3 groups : 34 patients received intravenous 20 % mannitol after operation ( mannitol group ) ; 32 patients received intravenous DM after operation ( DM group ) ; and 34 patients received neither dehydrating agent nor steroid after operation ( control group ) .
METHODS	There was no significant difference in gender , age , disease duration , clinical symptoms , lesion types , and lesion segments between groups ( P > 0.05 ) .
METHODS	The serum levels of inflammatory factors [ tumor necrosis factor a ( TNF-alpha ) , interleukin 1beta ( IL-1beta ) , and IL-6 ] were measured by ELISA at pre-operation and 3 , 24 , 48 , 72 , and 96 hours after operation .
METHODS	Low back and leg pain was determined by using visual analogue scale ( VAS ) score after operation .
RESULTS	All procedures were smoothly performed without major complications of nerve root injury , hematoma , or infection .
RESULTS	There was no significant difference in operation time and intraoperative blood loss between groups ( P > 0.05 ) .
RESULTS	The VAS score of low back pain showed no significant difference between groups at all time points after operation ( P > 0.05 ) ; the VAS score of leg pain in the DM group was significantly lower than that in the control group at all time points ( P < 0.05 ) , and than those in the mannitol group at 3 , 24 , 48 , and 96 hours after operation ( P < 0.05 ) .
RESULTS	The serum level of TNF-a in the DM group was significantly lower than that in the control group at all time points ( P < 0.05 ) , and than that in the mannitol group at 3 , 48 , 72 , and 96 hours after operation ( P < 0.05 ) .
RESULTS	The serum level of IL-1beta in the DM group was significantly lower than that in the control group at 3 , 24 , 48 , and 72 hours after operation ( P < 0.05 ) , and than that in the mannitol group at all time points after operation ( P < 0.05 ) .
RESULTS	The serum level of IL-6 in the DM group was significantly lower than that in the control group at 3 and 24 hours after operation ( P < 0.05 ) , and than that in the mannitol group at 3 , 24 , and 48 hours after operation ( P < 0.05 ) .
CONCLUSIONS	Intravenous 20 % mannitol may has no effect on postoperative low back and leg pain , while DM can markedly relieve leg pain after MI-TLIF .

###24982456
OBJECTIVE	To assess the efficacy of a second-line regimen of oxaliplatin and folinic acid-modulated fluorouracil in patients with advanced pancreatic cancer who have experienced progression while receiving gemcitabine monotherapy .
METHODS	A randomized , open-label , phase III study was conducted in 16 institutions throughout Germany .
METHODS	Recruitment ran from January 2004 until May 2007 , and the last follow-up concluded in December 2012 .
METHODS	Overall , 168 patients age 18 years or older who experienced disease progression during first-line gemcitabine therapy were randomly assigned to folinic acid and fluorouracil ( FF ) or oxaliplatin and FF ( OFF ) .
METHODS	Patients were stratified according to the presence of metastases , duration of first-line therapy , and Karnofsky performance status .
RESULTS	Median follow-up was 54.1 months , and 160 patients were eligible for the primary analysis .
RESULTS	The median overall survival in the OFF group ( 5.9 months ; 95 % CI , 4.1 to 7.4 ) versus the FF group ( 3.3 months ; 95 % CI , 2.7 to 4.0 ) was significantly improved ( hazard ratio [ HR ] , 0.66 ; 95 % CI , 0.48 to 0.91 ; log-rank P = .010 ) .
RESULTS	Time to progression with OFF ( 2.9 months ; 95 % CI , 2.4 to 3.2 ) versus FF ( 2.0 months ; 95 % CI , 1.6 to 2.3 ) was significantly extended also ( HR , 0.68 ; 95 % CI , 0.50 to 0.94 ; log-rank P = .019 ) .
RESULTS	Rates of adverse events were similar between treatment arms , with the exception of grades 1 to 2 neurotoxicity , which were reported in 29 patients ( 38.2 % ) and six patients ( 7.1 % ) in the OFF and FF groups , respectively ( P < .001 ) .
CONCLUSIONS	Second-line OFF significantly extended the duration of overall survival when compared with FF alone in patients with advanced gemcitabine-refractory pancreatic cancer .

###24721892
OBJECTIVE	Patients receiving hemodialysis often perceive their caregivers are overburdened .
OBJECTIVE	We hypothesize that increasing hemodialysis frequency would result in higher patient perceptions of burden on their unpaid caregivers .
METHODS	In two separate trials , 245 patients were randomized to receive in-center daily hemodialysis ( 6 days/week ) or conventional hemodialysis ( 3 days/week ) while 87 patients were randomized to receive home nocturnal hemodialysis ( 6 nights/week ) or home conventional hemodialysis for 12 months .
METHODS	Changes in overall mean scores over time in the 10-question Cousineau perceived burden scale were compared .
RESULTS	In total , 173 of 245 ( 70 % ) and 80 of 87 ( 92 % ) randomized patients in the Daily and Nocturnal Trials , respectively , reported having an unpaid caregiver at baseline or during follow-up .
RESULTS	Relative to in-center conventional dialysis , the 12-month change in mean perceived burden score with in-center daily hemodialysis was -2.1 ( 95 % confidence interval , -9.4 to +5.3 ; P = 0.58 ) .
RESULTS	Relative to home conventional dialysis , the 12-month change in mean perceived burden score with home nocturnal dialysis was +6.1 ( 95 % confidence interval , -0.8 to +13.1 ; P = 0.08 ) .
RESULTS	After multiple imputation for missing data in the Nocturnal Trial , the relative difference between home nocturnal and home conventional hemodialysis was +9.4 ( 95 % confidence interval , +0.55 to +18.3 ; P = 0.04 ) .
RESULTS	In the Nocturnal Trial , changes in perceived burden were inversely correlated with adherence to dialysis treatments ( Pearson r = -0.35 ; P = 0.02 ) .
CONCLUSIONS	Relative to conventional hemodialysis , in-center daily hemodialysis did not result in higher perceptions of caregiver burden .
CONCLUSIONS	There was a trend to higher perceived caregiver burden among patients randomized to home nocturnal hemodialysis .
CONCLUSIONS	These findings may have implications for the adoption of and adherence to frequent nocturnal hemodialysis .

###24692284
OBJECTIVE	The first in class angiotensin receptor neprilysin inhibitor , LCZ696 has been shown to reduce levels of N-terminal pro-brain natriuretic peptide ( NT-proBNP ) , reduce left atrial size and improve New York Heart Association ( NYHA ) class in patients with heart failure with preserved ejection fraction ( HFpEF ) .
OBJECTIVE	We examined whether the effects of LCZ696 were independent of systolic blood pressure ( SBP ) lowering .
RESULTS	In the Prospective comparison of ARNi ( angiotensin receptor neprilysin inhibitor ) with ARB ( angiotensin receptor blocker ) on Management Of heart failUre with preserved ejectioN fracTion ( PARAMOUNT ) trial 301 patients were randomly assigned to LCZ696 or valsartan .
RESULTS	We examined the relationship between SBP lowering and LCZ696 on NT-proBNP level , left atrial size , NYHA class and estimated glomerular filtration rate ( eGFR ) .
RESULTS	By 12weeks blood pressure was reduced by 9mmHg ( SD 15 ) / 5mmHg ( SD 11 ) in patients receiving LCZ696 in comparison with 3mmHg ( SD 17 ) / 2mmHg ( SD 12 ) in those receiving valsartan .
RESULTS	The change in NT-proBNP was poorly correlated with change in SBP ( LCZ696 , r = 0.17 , P = 0.06 ; valsartan , r = 0.05 , P = 0.58 ) After adjustment for change in SBP , the ratio of change in NT-proBNP at 12weeks for LCZ696 vs. valsartan was 0.76 ( 95 % CI 0.63-0 .93 , P = 0.008 ) , and similar to the ratio not adjusting for SBP ( 0.76 , 95 % CI 0.63-0 .92 , P = 0.006 ) ; P for interaction was 0.38 ) .
RESULTS	Similarly , reduction in left atrial volume index at 36weeks , improvement in NYHA class and eGFR were all independent of the change in SBP .
CONCLUSIONS	In patients with HFpEF , the effect of the angiotensin receptor neprilysin inhibitor LCZ696 on NT-proBNP , left atrial volume , functional class , and eGFR was independent of reduction in SBP .

###25840035
BACKGROUND	Helping patients control obesity remains a clinical challenge for internists , and African Americans experience obesity rates higher than other racial/ethnic groups .
OBJECTIVE	To investigate whether a behavioral theory-based mobile health intervention would enhance weight loss when added to standard care among overweight/obese African American adults .
METHODS	A randomized controlled trial of 124 adults recruited from Baltimore-area African American churches .
METHODS	Participant follow-up ended March 2013 .
METHODS	Participants were randomized to standard care ( included one-on-one counseling sessions with a dietitian and a physician ) or standard care plus daily tailored text messages for 6 months .
METHODS	Text messages were delivered in phases : preparation , reinforcement of participant-selected diet and exercise goals , reflection , goal integration , weight loss methods , and maintenance .
METHODS	There were follow-up visits at 3 , 6 , and 12 months .
METHODS	Primary outcome was weight change from baseline to end-intervention at 6 months .
METHODS	Secondary outcomes included weight change at 3 months , engagement , and satisfaction with the intervention .
RESULTS	Sixty-three participants were randomized to the mobile health intervention and 61 to standard-care control .
RESULTS	Weights were collected in-window for 45 ( 36.3 % ) at 3 months and 51 ( 41.1 % ) at 6 months .
RESULTS	Mean weight loss at 3 months was 2.5 kg greater in the intervention group compared with standard care ( 95 % confidence interval [ CI ] , -4.3 to-0 .6 ; P < .001 ) , and 3.4 kg greater ( 95 % CI,-5 .2 to-1 .7 ; P = .001 ) at 6 months .
RESULTS	Degree of engagement with messages was correlated with weight loss .
CONCLUSIONS	While attrition was high , this study supports a tailored , interactive text-message intervention to enhance weight loss among obese African-American adults .

###25657075
BACKGROUND	Severe immobility due to lesions of the brain necessitates therapeutic positioning over the long term .
BACKGROUND	There is little scientific evidence concerning the efficacy of different positioning methods .
BACKGROUND	This clinical trial compares the effects of conventional positioning ( CON ) with those of positioning in neutral ( LiN ) .
METHODS	A prospective , multicenter , investigator-blinded , randomized , controlled trial was performed on a total of 218 non-ambulatory patients ( underlying disease : stroke , 141 patients ; hypoxic brain damage , 28 ; traumatic brain injury , 20 ; other , 29 ) .
METHODS	The subjects were randomly assigned to either LiN ( 105 patients ) or CON ( 113 patients ) and stratified within each of these two positioning concepts to five different positions .
METHODS	They remained in the assigned positions for two hours .
METHODS	The primary endpoint was change in the passive range of motion ( PROM ) of the hip joints .
METHODS	Secondary endpoints were change in the PROM of the shoulder joints and patient comfort .
RESULTS	Patients in the LiN group had a significantly better PROM of the hips after positioning than those in the CON group ( difference , 12.84 ; p < 0.001 ; 95 % confidence interval [ CI ] , 5.72-19 .96 ) .
RESULTS	The same was true for PROM of shoulder flexion ( 11.85 ; p < 0.001 ; 95 % CI , 4.50-19 .19 ) and external rotation ( 7.08 ; p < 0.001 ; 95 % CI : 2.70-11 .47 ) .
RESULTS	81 % of patients in the LiN group reported their comfort level as good , compared to only 38 % in the CON group ( p < 0.001 ) .
CONCLUSIONS	Positioning severely immobilized patients in LiN for two hours improved passive hip and shoulder mobility and patient comfort compared to conventional positioning .
CONCLUSIONS	Further studies are needed to determine whether prolonged LiN positioning might improve rehabilitation and quality of life , prevent pressure sores , or ease nursing care .

###25470096
OBJECTIVE	To compare the effects of right unilateral ( RUL ) electroconvulsive therapy ( ECT ) and algorithm-based pharmacologic treatment ( APT ) on neurocognitive function in treatment-resistant bipolar disorder depression .
METHODS	Inpatients with DSM-IV-TR-diagnosed , treatment-resistant bipolar depression , who were acutely admitted to 1 of the 7 clinical study centers in Norway , were recruited from May 2008 to April 2011 into a prospective , randomized controlled , 6-week acute treatment trial .
METHODS	General neurocognitive function was assessed with the MATRICS Consensus Cognitive Battery ( MCCB ) , and retrograde memory for autobiographical events was assessed with the Autobiographical Memory Interview-Short Form ( AMI-SF ) before and shortly after ( mean = 23.5 days ) a trial with either RUL brief-pulse ECT ( mean dose = 233.3 mC ) or APT .
RESULTS	Seventy-three patients entered , and 39 ( nECT = 19 , nAPT = 20 ) completed .
RESULTS	Both groups showed improvements in all MCCB domain scores , with no significant differences between the study groups ( no interaction effect : F , = 1.52 , P = NS ) .
RESULTS	Improvements in neurocognitive performance were significantly correlated with reductions in depression ratings posttreatment .
RESULTS	The AMI-SF score was significantly lower ( based on consistent answers from pre - to posttreatment ) in the ECT group ( 72.9 % ) than in the APT group ( 80.8 % , P = .025 ) , indicating reduced consistency in autobiographical memory after ECT .
CONCLUSIONS	General neurocognitive function was unaffected by RUL brief-pulse ECT treatment and positively related to improved mood in bipolar depression .
CONCLUSIONS	Autobiographical memory consistency was reduced in patients treated with ECT .
CONCLUSIONS	The results suggest that ECT can be used in treatment-resistant bipolar depression without compromising general neurocognitive function .
CONCLUSIONS	The clinical relevance of reduced autobiographical memory consistency in the ECT group requires further investigation .
BACKGROUND	ClinicalTrials.gov identifier : NCT00664976 .

###24656867
OBJECTIVE	The purpose of this study was to evaluate the effectiveness of the application of analyzing treadmill , muscle strengthening , and balance training compared with a standard care intervention in patients with diabetic neuropathy .
METHODS	Twenty-seven patients , 63 % female ( mean standard deviations age , 72 9 years ) , with diabetic neuropathy randomly assigned to receive a multimodal manual treatment approach including analyzing treadmill with feedback focused , isokinetic dynamometric muscle strengthening , and balance retraining on dynamic balance platform or a standard care intervention for activities targeted to improve endurance , manual exercises of muscle strengthening , stretching exercises , gait , and balance exercises ( 5 weekly over 4 weeks ) .
METHODS	This study was designed as a double-blind , randomized clinical trial .
METHODS	Measures were assessed at pretreatment , 4 weeks posttreatment , and 2-month follow-up .
RESULTS	No important baseline differences were observed between groups .
RESULTS	At the end of the treatment period , the experimental group showed a significant increase in gait endurance in a 6-minute walk test , 65.6 m ( F [ 2.0 ] = 9.636 ; P = .001 ) .
RESULTS	In addition , the 6-minute walk test increased after the intervention , and an even greater difference was found at follow-up ( P = .005 ) for the standard care group .
RESULTS	The Functional Independence Measure in both groups increased ( P < .01 ) and continued until the follow-up in the standard care group ( P = .003 ) .
CONCLUSIONS	The results suggest that the experimental rehabilitation program showed positive effects on the gait endurance after 4 weeks of treatment , whereas it did not produce significant improvements of the gait speed .
CONCLUSIONS	Both the treatments produced significant improvement of functionalities of the patient .

###24771728
BACKGROUND	Median sternotomy is the preferred approach for open heart surgeries .
BACKGROUND	The sternotomy incision is predominantly closed with either steel wire or polyester suture .
BACKGROUND	The type of material used is primarily based on the surgeon 's choice , and both materials achieve a good result .
BACKGROUND	No prospective clinical study has been undertaken to evaluate differences in the incidence of wound infection and the degree of pain associated with both techniques .
METHODS	Our randomized controlled double-blind study included 200 adults undergoing single-valve replacement .
METHODS	The technique of surgery , apart from the material used for sternal closure , was the same in both groups .
METHODS	Postoperatively , patients were analyzed for wound infection and wound pain based on the ASEPSIS score and Numeric Pain Rating Score , respectively .
RESULTS	The polyester suture group had a significantly higher mean ASEPSIS score , indicating a higher incidence of wound infection , and more late wound complications .
RESULTS	The polyester suture group also had a significantly higher mean pain score .
RESULTS	The steel wire group had significantly higher mediastinal drain output in the first 48 h after surgery .
CONCLUSIONS	The use of polyester suture for sternal closure in adult patients results in increased wound infection , wound pain , and late wound complications , but lower mediastinal drain output .

###24402594
OBJECTIVE	To compare surgeons ' intraoperative surgeon acceptability or assessment of the operative field regarding bowel contents and patients ' satisfaction with or without a mechanical bowel preparation before reconstructive vaginal prolapse surgery .
METHODS	In this single-blind , randomized trial , women scheduled to undergo vaginal prolapse surgery with a planned apical suspension and posterior colporrhaphy were allocated using block randomization to an intervention or control group .
METHODS	Surgeons were blinded to patient allocation .
METHODS	One day before surgery , mechanical bowel preparation instructions consisted of a clear liquid diet and two self-administered saline enemas ; the participants in the control group sustained a regular diet and nothing by mouth after midnight .
METHODS	The primary outcome was surgeons ' intraoperative assessment of the surgical field regarding bowel content as measured on a 4-point Likert scale ( 1 , excellent ; 4 , poor ) .
METHODS	Secondary outcomes included participant satisfaction and bowel symptoms .
METHODS	The primary outcome was determined by intention-to-treat analysis and other analyses were per protocol .
RESULTS	Of the 150 women randomized ( 75 women to intervention and control group ) , 145 completed the study .
RESULTS	No differences existed in the demographic , clinical , and intraoperative characteristics between groups ( P > .05 ) .
RESULTS	Surgeons ' intraoperative assessment rating was 85 % `` excellent or good '' with bowel preparation compared with 90 % for participants in the control group ( odds ratio [ OR ] 0.59 , 95 % confidence interval [ CI ] 0.21-1 .61 ; P = .30 ) .
RESULTS	The bowel preparation group was less likely to report `` complete '' satisfaction compared with the participants in the control group ( OR 0.11 , 95 % CI 0.04-0 .35 ; P < .001 ) .
RESULTS	Abdominal fullness and cramping , fatigue , anal irritation , and hunger pains were greater in the bowel preparation group ( all P < .01 ) .
CONCLUSIONS	Before reconstructive vaginal surgery , mechanical bowel preparation conferred no benefit regarding surgeons ' intraoperative assessment of the operative field , reflected decreased patient satisfaction , and had increased abdominal symptoms .
BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT01431040 .
METHODS	I.

###24261301
OBJECTIVE	To observe clinical effect , feasibility and security of preconditioning of thermopaste application at Shenque ( CV 8 ) for relieving stretch reflex induced by procedure for prolapse and hemorrhoids ( PPH ) .
METHODS	A total of 100 cases of mixed hemorrhoids ( stage III and IV ) patients were randomized into 1.0 h , 0.5 h , 0 h and control ( no application ) groups ( n = 25 in each group ) according to a random number table .
METHODS	Thermopaste was applied to Shenque ( CV 8 ) 1.0 h and 0.5 h before PPH or conducted simultaneously with PPH .
METHODS	The mean arterial pressure , heart rate , blood oxygen saturation of patients before and after anastomose operation , and the incidence of adverse reactions within 24 hours after the procedure were monitored and recorded .
METHODS	The patient 's pain degree was assessed by using visual analogue scale .
RESULTS	After the preconditioning , of the 25 patients in the 0.5 h group ( 0.5 h G ) , 14 experienced marked improvement ( in the stretch reflex during PPH ) , 10 had an improvement , and 1 was invalid , respectively .
RESULTS	The markedly effective rate and the total effective rate were 56 % and 96 % , respectively .
RESULTS	The therapeutic effects for inhibiting stretch reflect being from the better to the poorer were 0.5 h G > 1.0 h G > 0 h G > NG .
RESULTS	The heart rate and blood pressure from more stable to lesser stable were 0.5 h G > 1.0 h G > 0 h G > NG .
RESULTS	The patients ' pain reaction during operation and their adverse effects of nausea , vomiting , abdominal distention and abdominal pain , etc. occurred during operation also presented the same tendency in the 4 groups .
CONCLUSIONS	Thermopaste application to Shenque ( CV 8 ) can effectively prevent and control visceral reflex in patients undergoing PPH , which effect is significantly better when conducted 0.5 hour before the operation .

###25436319
OBJECTIVE	This study aims to investigate the safety and efficacy of hepatic arterial infusion chemotherapy ( HAIC ) on liver metastases from pancreatic cancer after pancreatectomy .
METHODS	We randomly assigned 106 patients with pancreatic cancer after pancreatectomy between 2005 and 2010 to receive 2 cycles of HAIC plus 4 cycles of systemic chemotherapy ( Combined Therapy ) or 6 cycles of systemic chemotherapy alone ( Monotherapy ) .
METHODS	Both the HAIC and systemic chemotherapy regimen consisted of a 5-hour infusion of 5-fluorouracil 1000 mg/m2 on day 1 followed by gemcitabine 800 mg/m2 as an over 30-min infusion on day 1 and day 8 .
METHODS	The treatment was started on an average of 21.2 days after surgery and repeated every 4 weeks .
METHODS	The disease-free survival , overall survival and liver metastases-free survival were compared .
RESULTS	There was no significant difference in adverse effects between two groups .
RESULTS	Significant differences were found in 3-year overall survival ( Combined Therapy , 23.08 % ; Monotherapy , 14.81 % ; P = 0.0473 ) and liver metastases-free survival ( Combined Therapy , 80.77 % ; Monotherapy , 55.56 % ; P = 0.0014 ) .
CONCLUSIONS	HAIC effectively and safely prevents liver metastases and improves the prognosis of patients with pancreatic cancer after pancreatectomy .

###24758729
OBJECTIVE	This study evaluated the performance and acceptability of the Enlite ( ) glucose sensor ( Medtronic MiniMed , Inc. , Northridge , CA ) .
METHODS	Ninety adults with type 1 or type 2 diabetes wore two Enlite sensors on the abdomen and/or buttock for 6 days and calibrated them at different frequencies .
METHODS	On Days 1 , 3 , and 6 , accuracy was evaluated by comparison of sensor glucose values with frequently sampled plasma glucose values collected over a 12-h period .
METHODS	Accuracy was assessed at different reference glucose concentrations and during times when absolute glucose concentration rates of change were < 1 , 1-2 , and > 2 mg/dL/min .
METHODS	The sensor 's ability to detect hypoglycemia or hyperglycemia was evaluated with simulated alerts .
METHODS	Subject satisfaction was evaluated with a 7-point Likert-type questionnaire , with a score of 7 indicating strong agreement .
RESULTS	With abdomen sensors under actual-use calibration ( mean , 2.8 0.9 times/day ) , the overall mean ( median ) absolute relative difference ( ARD ) values between sensor and reference values were 13.6 % ( 10.1 % ) ; the corresponding buttock sensor ARD values were 15.5 % ( 10.5 % ) .
RESULTS	With abdomen sensors under minimal calibration ( mean , 1.2 0.9 times/day ) , the mean ( median ) ARD values were 14.7 % ( 10.8 % ) .
RESULTS	Mean ARD values of abdomen sensors at rates of change of < 1 , 1-2 , and > 2 mg/dL/min were 13.6 % , 12.9 % , and 16.3 % , respectively .
RESULTS	With abdomen sensors , 79.5 % and 94.1 % of hypoglycemic and hyperglycemic events , respectively , were correctly detected ; 81.9 % and 94.9 % of hypoglycemic and hyperglycemic alerts , respectively , were confirmed .
RESULTS	The failure rates for abdomen and buttock sensors were 19.7 % and 13.9 % , respectively .
RESULTS	Mean responses to survey questions for all subjects related to comfort and ease of use were favorable .
CONCLUSIONS	The Enlite sensor provided accurate data at different glucose concentrations and rates of change .
CONCLUSIONS	Subjects found the sensor comfortable and easy to use .

###25464438
BACKGROUND	Human autoimmune myocarditis is characterized by an increased frequency of serum organ and disease-specific anti-heart autoantibodies ( AHA ) in affected patients .
BACKGROUND	To assess whether AHA are directly pathogenic , we used the passive transfer technique of AHA from patients to normal Balb/c mice to induce an experimental myocarditis .
METHODS	In keeping with a classical passive transfer experiment , sera from 5 AHA positive myocarditis patients ( 3 male , mean age 30 11 years , 3 with giant cell and 2 with lymphocytic myocarditis ) were affinity purified and injected into 25 Balb/c mice .
METHODS	As controls , affinity purified sera from 5 healthy donors were passively transferred to 25 Balb/c mice .
METHODS	Further 15 control mice were injected with phosphate-buffered saline and 9 mice did not receive any injection .
METHODS	In all patients cardiac-specific AHA of IgG class had been previously detected by an indirect immunofluorescence ( IFL ) technique on cryostat sections of O blood group human heart .
METHODS	The animals were sacrificed after 4 weeks and the hearts were blindly examined for histological evidence of myocarditis by an expert cardiac pathologist .
RESULTS	Myocarditis was present in 13/25 ( 52 % ) of the mice which received affinity-purified IgG from patients .
RESULTS	The findings of severe , moderate or mild myocarditis were more common in the mice which received affinity-purified IgG from patients ( 20 % ; 20 % and 12 % ) than in control animals ( 2 % , p = 0.01 ; 0 % , p = 0.003 ; and 0 % , p = 0.04 respectively ) .
CONCLUSIONS	These findings provide a new evidence for AHA-mediated pathogenicity in human myocarditis , according to Rose-Witebsky criteria .

###26017126
BACKGROUND	Traumatic brain injury ( TBI ) is a leading cause of death and disability worldwide .
BACKGROUND	Prophylactic hypothermia is effective in laboratory models , but clinical studies to date have been inconclusive , partly because of methodological limitations .
BACKGROUND	Our Prophylactic Hypothermia Trial to Lessen Traumatic Brain Injury ( POLAR ) randomised controlled trial is currently underway comparing early , sustained hypothermia versus standard care in patients with severe TBI .
BACKGROUND	We describe our study protocol and the challenges in conducting prophylactic hypothermia research in TBI .
METHODS	We aim to randomise 500 patients to either prophylactic 33C hypothermia initiated within 3 hours of injury and continued for at least 72 hours , or standard normothermic management .
METHODS	Patients will be enrolled by paramedic services in the prehospital setting , or by emergency department staff at participating sites in Australia , New Zealand and Europe .
METHODS	The primary outcome will be the eight-level extended Glasgow outcome scale ( GOSE ) , dichotomised to favourable and unfavourable outcomes at 6 months after injury .
METHODS	Secondary outcomes will include mortality at hospital discharge and at 6 months , ordinal analyses of 6-month GOSE outcomes , quality of life with health economic evaluations and the differential proportion of adverse events .
METHODS	We will predefine subgroup and interaction analyses .
CONCLUSIONS	After a run-in phase , recruitment for our main study began in December 2010 .
CONCLUSIONS	When the study is completed , we aim to provide evidence on the efficacy of prophylactic hypothermia in TBI to guide clinicians in their management of this devastating condition .

###25146513
OBJECTIVE	To assess the efficacy and safety of fluvastatin sodium extended-release tablets ( fluvastatin XL ) 80 mg once daily compared to fluvastatin sodium immediate-release capsules ( fluvastatin IR ) 40 mg twice daily in Chinese hyperlipidemic patients with moderate or high cardiovascular risk .
METHODS	In this multi-center , randomized , double-blind , double-dummy , active-controlled , parallel-group study , after 6-week open-label treatment with fluvastatin IR 40 mg once daily , patients who did not reach their lipid goals were randomized to 12-week double-blind treatment with fluvastatin XL 80 mg once daily or fluvastatin IR 40 mg twice daily .
RESULTS	( 1 ) There were 218 patients enrolled in each group .
RESULTS	At the study endpoint , no statistical difference was found in the mean percent change from baseline for LDL-C with -8.69 % [ from ( 3.504 0.060 ) mmol/L to ( 3.153 0.065 ) mmol/L ] in the fluvastatin XL group and -7.89 % [ from ( 3.491 0.050 ) mmol/L to ( 3.181 0.060 ) mmol/L ] in the fluvastatin IR group ( P > 0.05 ) .
RESULTS	The 95 % CI for difference between the two groups in adjusted mean percent change from baseline was ( -4.70 % -3.09 % ) , which was within the pre-specified non-inferiority margin .
RESULTS	In the fluvastatin XL group , the proportion of patients with moderate cardiovascular ( CV ) risk and high CV risk achieving their LDL-C treatment goals at endpoint was 50.0 % and 31.5 % respectively , while the proportion was 42.5 % and 24.5 % respectively in the fluvastatin IR group .
RESULTS	No significant difference was found between the two groups in the proportion of patients who reached their lipid goals and the changes from baseline with other lipid parameters .
RESULTS	( 2 ) Similar safety profiles were observed in the two treatment groups , with 21.1 % adverse event ( AE ) ( 8.3 % study-drug related AE ) in the fluvastatin XL group and 17.0 % AE ( 6.3 % study-drug related AE ) in the fluvastatin IR group .
CONCLUSIONS	The efficacy of fluvastatin XL 80 mg once daily is comparable to fluvastatin IR 40 mg twice daily in Chinese hyperlipidemic patients with moderate or high cardiovascular risk and both treatments are safe and well-tolerated .

###25108749
OBJECTIVE	The purpose of this study was to evaluate the short-term effects of classic massage ( CM ) and connective tissue massage ( CTM ) on pressure pain threshold and muscle relaxation response in women with chronic neck pain .
METHODS	Participants included 45 female volunteers ( ages between 25 and 45 years ) presenting to the Kroglu State Hospital Neurosurgery Polyclinic who had experienced neck pain for 3 to 6 months .
METHODS	The volunteers were randomly assigned to 2 groups ( CM or CTM to the thoracic spine and the neck ) .
METHODS	Each treatment was carried out for 1 session .
METHODS	Outcome measures were obtained before and after treatment , which included pressure pain threshold that was measured with an algometer and muscle relaxation response that was evaluated with electromyography biofeedback ( EMG-BF ) .
RESULTS	Pressure pain threshold of the sternocleidomastoid muscle was significantly different for the CM ( P < .05 ) group .
RESULTS	The EMG-BF values were significantly different for the CTM group ( P < .05 ) .
RESULTS	Comparing the results of CM and CTM , EMG-BF averages favored the CTM group ( P < .05 ) .
CONCLUSIONS	For the group of women with chronic neck pain that were included in this study , 1 treatment of CTM demonstrated relaxation responses and 1 treatment of CM demonstrated pain reduction .

###24814382
OBJECTIVE	It is unclear whether advising a prudent breakfast alone is sufficient to improve blood lipids and cardiometabolic risk factors in overweight hypercholesterolemic subjects .
OBJECTIVE	The aim of this study was to investigate whether a prudent low-fat breakfast ( PB ) rich in dietary fiber lowers low-density lipoprotein cholesterol ( LDL-C ) and other cardiometabolic risk factors in subjects with elevated LDL-cholesterol levels .
METHODS	In a parallel , controlled , 12-week study , 79 healthy overweight subjects ( all regular breakfast eaters ) were randomly allocated to a group that received a PB based on Nordic foods provided ad libitum or a control group that consumed their usual breakfast .
METHODS	The primary outcome was plasma LDL-C .
METHODS	Secondary outcomes were other blood lipids , body weight , sagittal abdominal diameter ( SAD ) , glucose tolerance , insulin sensitivity and inflammation markers ( C-reactive protein [ CRP ] and tumor necrosis factor receptor-2 [ TNF-R2 ] ) , and blood pressure .
METHODS	The PB was in accordance with national and Nordic nutrition recommendations and included oat bran porridge with low-fat milk or yogurt , bilberry or lingonberry jam , whole grain bread , low-fat spread , poultry or fatty fish , and fruit .
RESULTS	No differences were found in LDL-C , other blood lipids , body weight , or glucose metabolism , but SAD , plasma CRP , and TNF-R2 decreased more during PB compared with controls ( p < 0.05 ) .
RESULTS	In the overall diet , PB increased dietary fiber and - glucan compared with controls ( p < 0.05 ) .
CONCLUSIONS	Advising a prudent breakfast for 3 months did not influence blood lipids , body weight , or glucose metabolism but reduced markers of visceral fat and inflammation .
CONCLUSIONS	The trial was registered in the Current Controlled Trials database ( http://www.controlled-trials.com ) ; International Standard Randomized Controlled Trial Number ( ISRCTN ) : 84550872 .

###25017575
BACKGROUND	Varicose veins are treated under local infiltration anesthesia .
BACKGROUND	Literature shows that adding sodium bicarbonate reduces the pain associated with local infiltration anesthesia .
BACKGROUND	Nonetheless , sodium bicarbonate is underused .
OBJECTIVE	We sought to assess if the use of a solution of mepivacaine 2 % plus adrenaline with sodium bicarbonate 1.4 % results in less pain associated with local infiltration anesthesia preceding ambulatory phlebectomies , compared with standard preparation diluted with normal saline .
METHODS	In all , 100 adult patients undergoing scheduled ambulatory phlebectomy were randomized to receive either a solution of mepivacaine chlorhydrate 2 % plus adrenaline in sodium bicarbonate 1.4 % or a similar solution diluted in normal saline 0.9 % .
RESULTS	Median pain scores associated with local infiltration anesthesia reported in the intervention and control groups were 2 ( SD = 1.6 ) and 5 ( SD = 2.0 ) ( P < .0001 ) , respectively .
RESULTS	A general linear model with bootstrapped confidence intervals showed that using the alkalinized solution would lead to a reduction in pain rating of about 3 points .
CONCLUSIONS	Patients were not asked to distinguish the pain of the needle stick from the pain of the infiltration .
CONCLUSIONS	Moreover , a complete clinical study of sensitivity on the infiltrated area was not conducted .
CONCLUSIONS	Data obtained from this study may contribute to improve local infiltration anesthesia in ambulatory phlebectomy and other phlebologic procedures .

###25377166
BACKGROUND	We hypothesized that the time to successful fibreoptic tracheal intubation through the nasal route would be faster than the oral route for both experts and trainees in children < 2 yr of age .
METHODS	One hundred children , 24 months and under in age , were randomized to an operator ( expert or trainee ) , and route ( nasal or oral ) for fibreoptic tracheal intubation .
METHODS	Three separate times were then measured : ( i ) time to first glottic view , ( ii ) time to carinal view , and ( iii ) total time to successful tracheal intubation .
METHODS	The number of attempts made , manoeuvres needed to obtain an adequate laryngeal view , and manoeuvres for tracheal tube passage were also recorded .
RESULTS	Time to successful tracheal intubation was significantly faster for experts than trainees .
RESULTS	There was no difference in the time to tracheal intubation between the nasal and oral routes for experts .
RESULTS	In trainees , intubation times were shorter for the nasal route-median ( inter-quartile range ) time ( s ) to carinal view was 35 ( 27-63 ) for the nasal route vs 59 ( 38-94 ) for the oral route ( P = 0.03 ) , and the median time to successful tracheal intubation were 62 ( 49-122 ) vs 117 ( 61-224 ) , P = 0.05 , for the nasal and oral routes , respectively .
RESULTS	For trainees , the oral route required a greater number of airway manoeuvres for adequate laryngeal views and passage of the tracheal tube compared with the nasal route .
CONCLUSIONS	For clinicians with less experience in using paediatric bronchoscopes , fibreoptic tracheal intubation through the nasal route may be a more straightforward process than the oral route in children < 2 yr of age .
BACKGROUND	NCT02029300 ( www.clinicaltrials.gov ) .

###25475246
BACKGROUND	Adverse events ( AEs ) , defined as unintended patient harm related to healthcare provided rather than an underlying medical condition , represent a significant threat to patient safety and public health .
BACKGROUND	The emergency department ( ED ) is a high-risk patient safety setting for many reasons including presentation ` outside of regular hours ' , high patient volumes , and a chaotic work environment .
BACKGROUND	Children have also been identified as particularly vulnerable to AEs .
BACKGROUND	Despite the identification of the ED as a high-risk setting and the vulnerability of the paediatric population , little research has been conducted regarding paediatric patient safety in the ED .
BACKGROUND	The study objective is to generate an estimate of the risk and type of AEs , as well as their preventability and severity , for children seen in Canadian paediatric EDs .
METHODS	This multicentre , prospective cohort study will enrol patients under 18 years of age from nine paediatric EDs across Canada .
METHODS	A stratified cluster random sampling scheme will be used to ensure patients recruited are representative of the overall ED population .
METHODS	A rigorous , standardised two-stage process will be used for AE identification .
METHODS	The primary outcome will be the proportion of children with AEs associated with ED care in the 3 weeks following the ED visit .
METHODS	Secondary outcomes will include the proportion of children with preventable AEs and the types and severity of AEs .
METHODS	We will aim to recruit 5632 patients over 1 year and this will allow us to detect a proportion of patients with an AE of 5 % ( to within an absolute margin of error of 0.6 % ) .
BACKGROUND	Ethics approval has been obtained from participating sites .
BACKGROUND	Results will be disseminated through presentations , peer review publications , linkages with emergency research network and a webinars for key knowledge user groups .
BACKGROUND	This study is registered at Clinicaltrials.gov ( NCT02162147 ; https://clinicaltrials.gov/ct2/show/NCT02162147 ) .

###24849793
OBJECTIVE	To investigate whether Wii Sports Resort training is effective and if any benefits are maintained .
METHODS	Randomized , single-blind trial .
METHODS	Sixty-two hemiplegic children with cerebral palsy ( 6-13 years ) .
METHODS	Experimental group undertook six weeks of home-based Wii Sports Resort training plus usual therapy , while the control group received usual therapy .
METHODS	Outcomes were coordination , strength , hand function , and carers ' perception of hand function , measured at baseline , six , and 12 weeks by a blinded assessor .
RESULTS	There was a trend of mean difference ( MD ) for the experimental group to have more grip strength by six ( MD 4.0 N , 95 % confidence interval ( CI ) -0.8 to 8.8 , p = 0.10 ) and 12 ( MD 4.1 N , 95 % CI -2.1 to 10.3 , p = 0.19 ) weeks , and to have a higher quantity of hand function according to carers ' perception by six ( MD 4.5 N , 95 % CI -0.7 to 9.7 , p = 0.09 ) and strengthened by 12 ( MD 6.4 , 95 % CI 0.6 to 12.3 , p = 0.03 ) weeks than the control group .
RESULTS	There was no difference between groups in coordination and hand function by six or 12 weeks .
CONCLUSIONS	Wii training did not improve coordination , strength , or hand function .
CONCLUSIONS	Beyond the intervention , carers perceived that the children used their hands more .

###25236838
BACKGROUND	Sickle cell disease ( SCD ) is a genetic disorder common in malaria endemic areas .
BACKGROUND	In endemic areas , malaria is a major cause of morbidity and mortality among SCD patients .
BACKGROUND	This suggests the need for prompt initiation of efficacious anti-malarial therapy in SCD patients with acute malaria .
BACKGROUND	However , there is no information to date , on the efficacy or safety of artemisinin combination therapy when used for malaria treatment in SCD patients .
METHODS	Children with SCD and acute uncomplicated malaria ( n = 60 ) were randomized to treatment with artesunate-amodiaquine ( AA ) , or artemether-lumefantrine ( AL ) .
METHODS	A comparison group of non-SCD children ( HbAA genotype ; n = 59 ) with uncomplicated malaria were also randomized to treatment with AA or AL. .
METHODS	Recruited children were followed up and selected investigations were done on days 1 , 2 , 3 , 7 , 14 , 28 , 35 , and 42 .
METHODS	Selected clinical and laboratory parameters of the SCD patients were also compared with a group of malaria-negative SCD children ( n = 82 ) in steady state .
RESULTS	The parasite densities on admission were significantly lower in the SCD group , compared with the non-SCD group ( p = 0.0006 ) .
RESULTS	The parasite reduction ratio ( PRR ) was lower , clearance was slower ( p < 0.0001 ) , and time for initial parasitaemia to decline by 50 and 90 % were longer for the SCD group .
RESULTS	Adequate clinical and parasitological response ( ACPR ) on day 28 was 98.3 % ( 58/59 ) in the SCD group and 100 % ( 57/57 ) in the non-SCD group .
RESULTS	Corresponding ACPR rates on day 42 were 96.5 % ( 55/57 ) in the SCD group and 96.4 % ( 53/55 ) in the non-SCD group .
RESULTS	The fractional changes in haemoglobin , platelets and white blood cell counts between baseline ( day 0 ) and endpoint ( day 42 ) were 16.9 , 40.6 and 92.3 % , respectively , for the SCD group , and , 12.3 , 48.8 and 7.5 % , respectively , for the non-SCD group .
RESULTS	There were no differences in these indices between AA - and AL-treated subjects .
CONCLUSIONS	The parasite clearance of SCD children with uncomplicated malaria was slower compared with non-SCD children .
CONCLUSIONS	AA and AL showed similar clinical and parasitological effects in the SCD and non-SCD groups .
CONCLUSIONS	The alterations in WBC and platelet counts may have implications for SCD severity .
BACKGROUND	Current controlled trials ISRCTN96891086 .

###24673714
OBJECTIVE	To investigate the pharmacokinetics of enteric-coated mycophenolate sodium ( EC-MPS ) and the clinical outcome in kidney transplant recipients in the early post-transplantation phase .
OBJECTIVE	Then explain which regimen is more suitable for Chinese renal transplant recipients .
METHODS	In total , 60 de novo kidney transplant recipients treated with tacrolimus and steroids were randomised to receive EC-MPS at standard dose ( SD ; 1440mg/day ; n = 28 ) or low dose ( LD ; 1080mg/day ; n = 32 ) .
METHODS	Efficacy parameters , safety and tolerability were assessed over a 6-month study period .
METHODS	Full mycophenolic acid ( MPA ) areas under the curve ( AUCs ) were completed on days 3 and 5 , whereas a three-point limited sampling strategy ( LSS ) was utilised for MPA AUC assessments at 2weeks and months 1 , 3 and 6 ( the LSS for three-time-point MPA AUC 0-12h ( mgh/l ) = 15.99 +0.87 C1h +0.68 C2h +7.85 C4h ; r ( 2 ) = 0.8670 .
RESULTS	The mean AUC levels at day 3 and day 5 in the SD group were significantly higher than in the LD group ( 57.4 mgh/l vs. 38.2 mgh/l and 59.3 mgh/l vs. 44.8 mgh/l , respectively , p < 0.01 ) .
RESULTS	There was a trend for fewer clinically diagnosed acute rejections in the SD group vs. the LD group at 6months ( 7.1 % vs. 12.5 % ) .
RESULTS	This trend was also present when acute rejection was analysed as biopsy-proven cases .
RESULTS	There were significantly more acute rejections ( all definitions ) in patients with MPA AUC levels < 30mgh/l compared with those with MPA AUC levels 30mgh/l within 6months ( p < 0.05 ) .
RESULTS	Renal function , incidence of infection and haematological disorders were not significantly different in either study group .
CONCLUSIONS	Early adequate MPA exposure in renal transplant recipients can be achieved with a higher starting dose .
CONCLUSIONS	In addition , a SD regimen was as well-tolerated as a LD regimen .
CONCLUSIONS	Furthermore , early adequate MPA exposure significantly lowered the rate of acute rejection without compromising safety and tolerability .

###24965659
BACKGROUND	Blunt head trauma is a common cause of death and disability in children worldwide .
BACKGROUND	Cranial computed tomography ( CT ) , the reference standard for the diagnosis of traumatic brain injury ( TBI ) , exposes children to ionizing radiation which has been linked to the development of brain tumors , leukemia , and other cancers .
BACKGROUND	We describe the methods used to develop and test the effectiveness of a decision aid to facilitate shared decision-making with parents regarding whether to obtain a head CT scan or to further observe their child at home .
METHODS	This is a protocol for a multicenter clinician-level parallel randomized trial to compare an intervention group receiving a decision aid , ` Head CT Choice ' , to a control group receiving usual care .
METHODS	The trial will be conducted at five diverse emergency departments ( EDs ) in Minnesota and California .
METHODS	Clinicians will be randomized to decision aid or usual care .
METHODS	Parents visiting the ED with children who are less than 18-years-old , have experienced blunt head trauma within 24 hours , and have one or two risk factors for clinically-important TBI ( ciTBI ) from the Pediatric Emergency Care Applied Research Network head injury clinical prediction rules will be eligible for enrollment .
METHODS	We will measure the effect of Head CT Choice on : ( 1 ) parent knowledge regarding their child 's risk of ciTBI , the available diagnostic options , and the risks of radiation exposure associated with a cranial CT scan ( primary outcome ) ; ( 2 ) parent engagement in the decision-making process ; ( 3 ) the degree of conflict parents experience related to feeling uninformed ; ( 4 ) patient and clinician satisfaction with the decision made ; ( 5 ) the rate of ciTBI at seven days ; ( 6 ) the proportion of patients in whom a cranial CT scan is obtained ; and ( 7 ) seven-day healthcare utilization .
METHODS	To capture these outcomes , we will administer parent and clinician surveys immediately after each clinical encounter , obtain video recordings of parent-clinician discussions , administer parent healthcare utilization diaries , analyze hospital billing records , review the electronic medical record , and conduct telephone follow-up .
CONCLUSIONS	This multicenter trial will robustly assess the effectiveness of a decision aid on patient-centered outcomes , safety , and healthcare utilization in parents of children with minor head trauma in five diverse EDs .
BACKGROUND	ClinicalTrials.gov registration number : NCT02063087 .
BACKGROUND	Registration date February 13 , 2014 .

###25546925
OBJECTIVE	The aim of the study was to evaluate whether dietary intervention could reduce maternal and perinatal morbidity in pregnancies with one elevated 100 g oral glucose tolerance test ( OGTT ) value .
METHODS	The study was conducted among patients with positive 50 g glucose challenge test ( GCT ) and one elevated 100 g OGTT value .
METHODS	Plasma glucose value of 140 mg/dL was used as the threshold to define an abnormal GCT result .
METHODS	Carpenter and Coustan criteria were used to evaluate the OGTT results .
METHODS	Seventy-four women with normal GCT values comprised group I. Ninety-nine women with one elevated 100 g OGTT value who were given a caloric diet and 102 women with one elevated OGTT value in group III who received antenatal care with no special diet were randomly assigned to groups II and III , respectively .
METHODS	All women were followed up until the end of pregnancy .
METHODS	Poor maternal outcome was defined as : cesarean delivery performed due to cephalopelvic disproportion , failure to progress or fetal distress , preeclampsia , and/or preterm labor .
METHODS	Poor perinatal outcome was defined as : small for gestational age , large for gestational age or admission to a neonatal intensive care unit .
METHODS	The groups were compared in terms of maternal and perinatal outcomes .
RESULTS	The rates of macrosomia and large for gestational age incidence were significantly higher in group III as compared to groups I and II .
RESULTS	When we examined the multivariate effects of the risk factors considered to be predictive of poor maternal outcomes , group III was the only statistically significant risk factor ( OR = 3.90 , 95 % CI :1.95 - 7.84 ; p = < 0.001 ) .
RESULTS	In terms of poor perinatal outcome , one elevated OGTT value ( group III ) was the only significant risk factor ( OR = 2.92 , 95 % CI :1.56 -5.46 ; p = < 0.001 ) .
CONCLUSIONS	Women with one elevated OGTT value benefit from a structured program of diet therapy aimed to reduce adverse maternal and perinatal outcomes .

###24970388
BACKGROUND	Solar ultraviolet ( UV ) radiation has deleterious effects on the skin , including sunburn , photoaging and cancer .
BACKGROUND	Chocolate flavanols are naturally-occurring antioxidant and anti-inflammatory molecules that could play a role in preventing cutaneous UV damage .
BACKGROUND	We investigated the influence of 12-week high-flavanol chocolate ( HFC ) consumption on skin sensitivity to UV radiation , measured by minimal erythema dose ( MED ) .
BACKGROUND	We also evaluated skin elasticity and hydration .
METHODS	In this 2-group , parallel , double-blind , randomized controlled trial , 74 women aged 20-65 years and Fitzpatrick skin phototypes I or II were recruited from the general community in Quebec City , for randomization to either HFC ( n = 33 ) or low-flavanol chocolate ( LFC ) ( n = 41 ) .
METHODS	A blocked randomisation ( 4 ) , considering date of entry , skin type and age as factors , generated a sequentially-numbered allocation list .
METHODS	Study participants and research assistants were blinded .
METHODS	Totally , 30g of chocolate were consumed daily for 12weeks , followed by a 3-week washout period .
METHODS	MED was assessed at baseline and at 6 , 9 , 12 and 15weeks .
METHODS	Main outcome was changes in MED at week 12 .
RESULTS	33 participants in the HFC group and 41 in the LFC group were analyzed with 15weeks of follow-up .
RESULTS	Both groups showed similarly-increased MED at 12weeks ( HFC : 0.02520.1099 J/cm2 [ meanstandard deviation ( SD ) ] ; LFC : 0.01510.1118 ; mean difference ( MD ) : 0.0100 J/cm2 ; 95 % confidence interval ( CI ) : -0.0417 to 0.0618 ) .
RESULTS	However , after 3-week washout , the HFC group presented decreased MED ( -0.02480.1145 ) whereas no effect was seen in the LFC group ( 0.01680.1698 ) ( MD : -0.0417 ; 95 % CI : -0.1106 to 0.0272 ) .
RESULTS	Net temple elasticity increased slightly but significantly by 0.090.12 mm in the HFC group at 12weeks compared to 0.020.12 mm in the LFC group ( MD : 0.06 ; 95 % CI : 0.01 to 0.12 ) .
RESULTS	No significant adverse events were reported .
CONCLUSIONS	Our study failed to demonstrate a statistically-significant protective effect of HFC vs. LFC consumption on skin sensitivity to UV radiation as measured by MED .
BACKGROUND	ClinicalTrials.gov identifier : NCT01444625 .

###25768066
OBJECTIVE	Timely and efficient upper esophageal sphincter ( UES ) opening may be critical to safe transport of food or liquid to the stomach and to prevent aspiration during the swallow .
OBJECTIVE	The purpose of this study was to examine the temporal and biomechanical characteristics of the UES opening in stroke survivors .
METHODS	Maximum duration and width of the UES opening were obtained from 15 stroke survivors with aspiration and 15 stroke survivors with no aspiration .
METHODS	The control group was composed of 15 normal subjects undergoing videofluoroscopic swallowing examinations .
METHODS	The videofluoroscopic swallowing examination protocol was as follows : two swallows of 5 ml thin liquid and two swallows of 10 ml thin liquid .
METHODS	Statistical comparisons were made by repeated measurements of analysis of variance , and the significance level was set at P < 0.025 .
RESULTS	The stroke survivors with aspiration , the stroke survivors without aspiration , and the control group differed significantly for duration of UES opening ( P < 0.01 ) but not maximum width of UES opening .
CONCLUSIONS	Prolonged UES opening may be related to prolonged pharyngeal transition of the bolus and slower UES muscle contraction and hyolaryngeal excursion after stroke .

###24723282
BACKGROUND	Ceftobiprole , the active moiety of ceftobiprole medocaril , is a novel broad-spectrum cephalosporin , with bactericidal activity against a wide range of gram-positive bacteria , including Staphylococcus aureus ( including methicillin-resistant strains ) and penicillin - and ceftriaxone-resistant pneumococci , and gram-negative bacteria , including Enterobacteriaceae and Pseudomonas aeruginosa .
METHODS	This was a double-blind , randomized , multicenter study of 781 patients with hospital-acquired pneumonia ( HAP ) , including 210 with ventilator-associated pneumonia ( VAP ) .
METHODS	Treatment was intravenous ceftobiprole 500 mg every 8 hours , or ceftazidime 2 g every 8 hours plus linezolid 600 mg every 12 hours ; primary outcome was clinical cure at the test-of-cure visit .
RESULTS	Overall cure rates for ceftobiprole vs ceftazidime/linezolid were 49.9 % vs 52.8 % ( intent-to-treat [ ITT ] , 95 % confidence interval [ CI ] for the difference , -10.0 to 4.1 ) and 69.3 % vs 71.3 % ( clinically evaluable [ CE ] , 95 % CI , -10.0 to 6.1 ) .
RESULTS	Cure rates in HAP ( excluding VAP ) patients were 59.6 % vs 58.8 % ( ITT , 95 % CI , -7.3 to 8.8 ) , and 77.8 % vs 76.2 % ( CE , 95 % CI , -6.9 to 10.0 ) .
RESULTS	Cure rates in VAP patients were 23.1 % vs 36.8 % ( ITT , 95 % CI , -26.0 to -1.5 ) and 37.7 % vs 55.9 % ( CE , 95 % CI , -36.4 to 0 ) .
RESULTS	Microbiological eradication rates in HAP ( excluding VAP ) patients were , respectively , 62.9 % vs 67.5 % ( microbiologically evaluable [ ME ] , 95 % CI , -16.7 to 7.6 ) , and in VAP patients 30.4 % vs 50.0 % ( ME , 95 % CI , -38.8 to -0.4 ) .
RESULTS	Treatment-related adverse events were comparable for ceftobiprole ( 24.9 % ) and ceftazidime/linezolid ( 25.4 % ) .
CONCLUSIONS	Ceftobiprole is a safe and effective bactericidal antibiotic for the empiric treatment of HAP ( excluding VAP ) .
CONCLUSIONS	Further investigations are needed before recommending the use of ceftobiprole in VAP patients .
CONCLUSIONS	Clinical Trials Registration .
CONCLUSIONS	NCT00210964 , NCT00229008 .

###25421879
BACKGROUND	The efficacy of nebulized sodium nitrite ( AIR001 ) has been demonstrated in animal models of pulmonary arterial hypertension ( PAH ) , but it was not known if inhaled nitrite would be well tolerated in human subjects at exposure levels associated with efficacy in these models .
METHODS	Inhaled nebulized sodium nitrite was assessed in three independent studies in a total of 82 healthy male and female subjects .
METHODS	Study objectives included determination of the maximum tolerated dose ( MTD ) and dose-limiting toxicity ( DLT ) under normal and mildly hypoxic conditions , and following co-administration with steady-state sildenafil , assessment of nitrite pharmacokinetics , and evaluation of the fraction exhaled nitric oxide ( FENO ) and concentrations of iron-nitrosyl hemoglobin ( Hb ( Fe ) - NO ) and S-nitrosothiols ( R-SNO ) as biomarkers of local and systemic NO exposure , respectively .
RESULTS	Nebulized sodium nitrite was well tolerated following 6days of every 8 h administration up to 90mg , producing significant increases in circulating Hb ( Fe ) - NO , R-SNO , and FENO .
RESULTS	Pulmonary absorption of nitrite was rapid and complete , and plasma exposure dose was proportional through the MTD dosage level of 90mg , without accumulation following repeated inhalation .
RESULTS	At higher dosage levels , DLTs were orthostasis ( observed at 120mg ) and hypotension with tachycardia ( at 176mg ) , but venous methemoglobin did not exceed 3.0 % at any time in any subject .
RESULTS	Neither the tolerability nor pharmacokinetics of nitrite was impacted by conditions of mild hypoxia , or co-administration with sildenafil , supporting the safe use of inhaled nitrite in the clinical setting of PAH .
CONCLUSIONS	On the basis of these results , nebulized sodium nitrite ( AIR001 ) has been advanced into randomized trials in PAH patients .

###25684087
OBJECTIVE	To determine if temperature regulation is improved during neonatal transport using a servo-regulated cooling device when compared with standard practice .
METHODS	We performed a multicenter , randomized , nonmasked clinical trial in newborns with neonatal encephalopathy cooled during transport to 9 neonatal intensive care units in California .
METHODS	Newborns who met institutional criteria for therapeutic hypothermia were randomly assigned to receive cooling according to usual center practices vs device servo-regulated cooling .
METHODS	The primary outcome was the percentage of temperatures in target range ( 33-34C ) during transport .
METHODS	Secondary outcomes included percentage of newborns reaching target temperature any time during transport , time to target temperature , and percentage of newborns in target range 1 hour after cooling initiation .
RESULTS	One hundred newborns were enrolled : 49 to control arm and 51 to device arm .
RESULTS	Baseline demographics did not differ with the exception of cord pH. For each subject , the percentage of temperatures in the target range was calculated .
RESULTS	Infants cooled using the device had a higher percentage of temperatures in target range compared with control infants ( median 73 % [ IQR 17-88 ] vs 0 % [ IQR 0-52 ] , P < .001 ) .
RESULTS	More subjects reached target temperature during transport using the servo-regulated device ( 80 % vs 49 % , P < .001 ) , and in a shorter time period ( 44 31 minutes vs 63 37 minutes , P = .04 ) .
RESULTS	Device-cooled infants reached target temperature by 1 hour with greater frequency than control infants ( 71 % vs 20 % , P < .001 ) .
CONCLUSIONS	Cooling using a servo-regulated device provides more predictable temperature management during neonatal transport than does usual care for outborn newborns with neonatal encephalopathy .

###24660675
OBJECTIVE	Analysis of the patient-therapist relationship ( relationship work ) is considered a core active ingredient in dynamic psychotherapy .
OBJECTIVE	However , there are contradictory findings as for whom and under what circumstances these interventions are beneficial .
OBJECTIVE	This study investigates long-term effects of relationship work in the context of patients ' level of personality pathology and therapists ' self-reported parental feelings .
METHODS	One hundred outpatients seeking psychotherapy for depression , anxiety , and personality disorders were randomly assigned to weekly dynamic psychotherapy , either with or without relationship work , for 1 year .
METHODS	Personality pathology was evaluated before treatment as the sum of fulfilled personality disorder criteria items on the Structured Clinical Interview for DSM-III-R Personality Disorders .
METHODS	Therapist feelings were assessed using the Feeling Word Checklist-58 .
METHODS	The outcome variables were the Psychodynamic Functioning Scales and Inventory of Interpersonal Problems , measured at pretreatment , midtreatment , posttreatment , 1 year , and 3 years after treatment termination .
RESULTS	A significant interaction of treatment group ( relationship work vs. no relationship work ) by personality pathology by parental therapist feelings was present , indicating that parental feelings were differentially associated with long-term effects of relationship work , depending on the level of personality pathology .
RESULTS	In the context of low parental feelings , relationship work was positive for all patients .
RESULTS	However , when parental feelings were stronger , the specific effects of such interventions were even more positive for patients with high levels of personality pathology , but negative for patients with low levels of personality pathology .
CONCLUSIONS	The interaction of parental therapist feelings and patients ' personality pathology was strongly associated with the long-term specific effects of analysis of the patient-therapist relationship .

###25371402
BACKGROUND	A number of effective strategies have been developed to improve the quality of life in patients with COPD .
BACKGROUND	However , few have been implemented in patients with COPD at all stages in a community setting .
BACKGROUND	This study evaluated the efficacy of a complex COPD health management intervention in rural communities in China .
METHODS	A randomized controlled trial including 8,217 subjects with COPD was implemented from May 2008 to May 2012 in 14 community health-care centers .
METHODS	The control group of subjects received usual care , whereas the management group of subjects participated in a health management program that included assessing the subjects ' health status , giving regular health lectures , smoking cessation counseling , encouraging regular exercise , providing rehabilitative training and psychological counseling , and regular follow-up .
METHODS	As a primary outcome , we examined the changes in the BODE index .
METHODS	Secondary outcomes included depression and anxiety rates , current smoking rate , awareness of COPD , mortality , risk factors , respiratory medication use , hospital admissions , and emergency department visits .
RESULTS	After 4 y , the mean cumulative value of the BODE index increased by 0.7 per subject in the control group and decreased by 0.4 per subject in the health management group ( difference of 1.1 , 95 % CI 0.2-2 .0 , P < .001 ) .
RESULTS	Health management reduced anxiety symptoms by 4.8 % , depression symptoms by 6.6 % , current smoking by 14.3 % , mortality due to all causes by 9.0 % , hospitalizations due to all causes by 16.1 % , and emergency department visits due to all causes by 18.1 % ( P < .05 for all ) .
RESULTS	However , it increased immunomodulator use by 58.9 % , respiratory medication use by 14.1-21 .9 % , and awareness scores for COPD by 57.2 % ( P < .05 for all ) .
CONCLUSIONS	The health management program is an effective community-based strategy for the prevention and management of COPD in China , increasing awareness and knowledge among patients and practitioners and improving management within the limitations of access to pharmacotherapy .

###25893825
BACKGROUND	Telomeres are repetitive nucleoproteins that help maintain chromosomal stability by inhibiting exonucleolytic degradation , prohibiting inappropriate homologous recombination , and preventing chromosomal fusions by suppressing double-strand break signals .
BACKGROUND	We recently observed that men treated for clinically localized prostate cancer with shorter telomeres in their cancer-associated stromal cells , in combination with greater variation in cancer cell telomere lengths , were significantly more likely to progress to distant metastases , and die from their disease .
BACKGROUND	Here , we hypothesized that shorter stromal cell telomere length would be associated with prostate cancer risk at time of biopsy .
METHODS	Telomere-specific fluorescence in situ hybridization ( FISH ) analysis was performed in normal-appearing stromal , basal epithelial , and luminal epithelial cells in biopsies from men randomized to the placebo arm of the Prostate Cancer Prevention Trial .
METHODS	Prostate cancer cases ( N = 32 ) were either detected on a biopsy performed for cause or at the end of the study per trial protocol , and controls ( N = 50 ) , defined as negative for cancer on an end-of-study biopsy performed per trial protocol ( e.g. , irrespective of indication ) , were sampled .
METHODS	Logistic regression was used to estimate the association between mean telomere length of the particular cell populations , cell-to-cell telomere length variability , and risk of prostate cancer .
RESULTS	Men with short stromal cell telomere lengths ( below median ) had 2.66 ( 95 % CI 1.04-3 .06 ; P = 0.04 ) times the odds of prostate cancer compared with men who had longer lengths ( at or above median ) .
RESULTS	Conversely , we did not observe statistically significant associations for short telomere lengths in normal-appearing basal ( OR = 2.15 , 95 % CI 0.86-5 .39 ; P = 0.10 ) or luminal ( OR = 1.15 , 95 % CI 0.47-2 .80 ; P = 0.77 ) cells .
CONCLUSIONS	These findings suggest that telomere shortening in normal stromal cells is associated with prostate cancer risk .
CONCLUSIONS	It is essential to extend and validate these findings , while also identifying the cellular milieu that comprises the subset of cells with short telomeres within the prostate tumor microenvironment .

###24373585
BACKGROUND	Exposure to particulate air pollution increases respiratory and cardiovascular morbidity and mortality , especially in elderly , possibly through inflammation and vascular dysfunction .
METHODS	We examined potential beneficial effects of indoor air filtration in the homes of elderly , including people taking vasoactive drugs.Forty-eight nonsmoking subjects ( 51 to 81 years ) in 27 homes were included in this randomized , double-blind , crossover intervention study with consecutive two-week periods with or without the inclusion of a high-efficiency particle air filter in re-circulating custom built units in their living room and bedroom .
METHODS	We measured blood pressure , microvascular and lung function and collected blood samples for hematological , inflammation , monocyte surface and lung cell damage markers before and at day 2 , 7 and 14 during each exposure scenario .
RESULTS	The particle filters reduced the median concentration of PM2 .5 from approximately 8 to 4 g/m3 and the particle number concentration from 7669 to 5352 particles/cm3 .
RESULTS	No statistically significant effects of filtration as category were observed on microvascular and lung function or the biomarkers of systemic inflammation among all subjects , or in the subgroups taking ( n = 11 ) or not taking vasoactive drugs ( n = 37 ) .
RESULTS	However , the filtration efficacy was variable and microvascular function was within 2 days significantly increased with the actual PM2 .5 decrease in the bedroom , especially among 25 subjects not taking any drugs .
CONCLUSIONS	Substantial exposure contrasts in the bedroom and no confounding by drugs appear required for improved microvascular function by air filtration , whereas no other beneficial effect was found in this elderly population .

###25578927
BACKGROUND	Postmenopausal women have a high prevalence of hypertension and often develop arterial stiffness thereby increasing cardiovascular disease risk .
BACKGROUND	Although antihypertensive drug therapies exist , increasing numbers of people prefer natural therapies .
BACKGROUND	In vivo studies and a limited number of clinical studies have demonstrated the antihypertensive and vascular-protective effects of blueberries .
OBJECTIVE	To examine the effects of daily blueberry consumption for 8 weeks on blood pressure and arterial stiffness in postmenopausal women with pre - and stage 1-hypertension .
METHODS	This was an 8-week , randomized , double-blind , placebo-controlled clinical trial .
METHODS	Forty-eight postmenopausal women with pre - and stage 1-hypertension recruited from the greater Tallahassee , FL , area participated .
METHODS	Participants were randomly assigned to receive either 22 g freeze-dried blueberry powder or 22 g control powder .
METHODS	Resting brachial systolic and diastolic blood pressures were evaluated and arterial stiffness was assessed using carotid-femoral pulse wave velocity and brachial-ankle pulse wave velocity .
METHODS	C-reactive protein , nitric oxide , and superoxide dismutase were measured at baseline , 4 weeks , and 8 weeks .
METHODS	Statistical analysis was performed using a split plot model of repeated measures analysis of variance .
RESULTS	After 8 weeks , systolic blood pressure and diastolic blood pressure ( 13117 mm Hg [ P < 0.05 ] and 759 mm Hg [ P < 0.01 ] , respectively ) and brachial-ankle pulse wave velocity ( 1,401122 cm/second ; P < 0.01 ) were significantly lower than baseline levels ( 13814 mm Hg , 807 mm Hg , and 1,498179 cm/second , respectively ) , with significant ( P < 0.05 ) grouptime interactions in the blueberry powder group , whereas there were no changes in the group receiving the control powder .
RESULTS	Nitric oxide levels were greater ( 15.3511.16 mol/L ; P < 0.01 ) in the blueberry powder group at 8 weeks compared with baseline values ( 9.117.95 mol/L ) , whereas there were no changes in the control group .
CONCLUSIONS	Daily blueberry consumption may reduce blood pressure and arterial stiffness , which may be due , in part , to increased nitric oxide production .

###24368628
OBJECTIVE	To evaluate and compare the 1-year postoperative levels of posterior capsule opacification ( PCO ) as well as the level of anterior capsule retraction and opacification ( ACO ) after implantation of two single-piece hydrophobic acrylic intraocular lens ( IOL ) models .
METHODS	Randomised , controlled , prospective and double-blind study including 148 eyes of 74 patients ( age range , 61-80 years ) with bilateral senile cataract .
METHODS	Each patient underwent surgery with implantation of an AcrySof SA60AT ( Group A ) in one eye and Tecnis ZCB00 ( Group B ) in the fellow eye by the same experienced surgeon .
METHODS	Lens allocation to the first or second operated eye followed a randomisation process .
METHODS	At 12 months postoperatively , the PCO level was evaluated with the Evaluation of Posterior Capsule Opacification software , whereas the level of ACO and capsule retraction was evaluated and graded subjectively .
RESULTS	All surgeries were uneventful .
RESULTS	The mean PCO scores were 0.10 0.17 and 0.21 0.89 in Groups A and B , respectively , with no statistically significant differences between the groups ( p = 0.47 ) .
RESULTS	No significant correlation was found between the PCO scores in Groups A and B ( r = 0.16 , p = 0.17 ) .
RESULTS	Regarding ACO , it was present in 15 eyes ( 20.3 % ) and two eyes ( 2.7 % ) in Groups A and B , respectively ( p = 0.37 ) .
RESULTS	Capsular phimosis ( 13 eyes , 17.6 % ) was only observed in Group A.
CONCLUSIONS	Both IOLs had a similar low rate of PCO 1 year after surgery .
CONCLUSIONS	However , there seems to be a difference in the anterior capsule behaviour between both IOL models .

###24337919
OBJECTIVE	Subjective symptoms represent significant criteria of a patient 's health condition ; therefore , we focused on the long-term prevalence of heart failure symptoms and angina pectoris after myocardial infarction between two groups of patients in which two different therapeutic strategies were used during the acute phase of ST-elevation myocardial infarction ( STEMI ) .
METHODS	The PRAGUE-2 study enrolled 850 patients with STEMI .
METHODS	The patients were randomized into two groups - transport to a primary percutaneous coronary intervention ( PCI ) centre ( n = 429 ) vs. fibrinolysis in community hospitals ( n = 421 ) .
METHODS	The data were collected from either primary hospitals or PCI centres , as well as via questionnaires .
RESULTS	The mean follow-up was 58 months .
RESULTS	At 5 years , 45.4 % of patients were in New York Heart Association class I following primary PCI vs. 31.8 % of those treated with fibrinolysis ( OR 2.02 , 95 % CI 1.37-2 .97 , p < 0.002 ) .
RESULTS	At 5 years , 83.6 % of patients had no symptoms of angina pectoris following invasive therapy vs. 58 % of patients treated with fibrinolysis ( OR 4.47 , 95 % CI 2.79-7 .18 , p < 0.001 ) .
CONCLUSIONS	The symptoms of angina pectoris and heart failure were significantly lower in patients assigned to primary PCI in the acute stage of myocardial infarction compared with patients treated with fibrinolysis at the 5-year follow up .

###24717954
BACKGROUND	Allergic rhinitis ( AR ) presents as the main and most invasive symptom in the blocking of the nose .
BACKGROUND	This condition is almost always related to hypertrophy of the inferior turbinates .
BACKGROUND	When the medical treatments are found to be insufficient to solve the obstructive symptom of the patient , the quality of life is considerably impaired and it is often necessary to submit the patient to a surgical approach .
BACKGROUND	In the present study we aimed to establish the efficacy and safety of a new technique recently introduced for the shrinkage of hypertrophic turbinates using a specific device , based on a new radiofrequency energy that does not produce thermal mucosal damage , viz. , quantic molecular resonance ( QMR ) in a group of patients with persistent moderate-severe allergic rhinitis , in addition to standard medical treatment ( nasal steroid and oral antihistamine ) .
METHODS	All patients were randomly assigned to two homogeneous groups ( group A , control subjects ; group B , treated patients ) ; each group included 145 individuals .
METHODS	During the study , both groups received standard medications ( ebastine , 10-mg tablet , and budesonide nasal spray at 100 micrograms/nostril per day ) for 90 days .
METHODS	Before the medical treatment , patients in group B underwent inferior endoscopic turbinoplasty using QMR .
METHODS	All of the patients enrolled in this study were submitted to a complete otorhinolaryngologic evaluation with objective clinical examination ( basal rhinomanometry , nasal provocation test rhinomanometry , and mucociliary transport time ) , endoscopy , and questionnaires ( 22-item Sino-Nasal Outcome Test and visual analog scale for nasal symptoms ) .
RESULTS	Greater efficacy has been achieved using a combined approach with the association of medical and QMR treatment , compared with medical treatment alone , in the control of AR associated with hypertrophy of the inferior turbinates , in particular in the reduction of turbinate volume at rhinoendoscopy .
CONCLUSIONS	QMR inferior turbinoplasty , in conjunction with medical therapy , improves the nasal flow , without any thermal mucosal damage , more effectively when compared with medical treatment alone in persistent moderate-to-severe AR .
CONCLUSIONS	In particular , local reactivity , as measured with nasal provocation test , was noticeably reduced .

###24894701
OBJECTIVE	To assess whether immunization attenuates nicotinic stimulation of the brain and elucidate brain and behavioural responses during exposure to smoking cues and a working memory task .
METHODS	Randomized , placebo-controlled parallel-group , repeated-measures design .
METHODS	Maastricht University , the Netherlands .
METHODS	Forty-eight male smokers were randomized to receive five injections with either 400g/ml of the 3 ' - aminomethylnicotine Pseudomonasaeruginosa r-Exoprotein-conjugated vaccine or placebo .
METHODS	Subjects were tested on two occasions , once after a nicotine challenge and once after a placebo challenge , and were asked to refrain from smoking 10 hours before testing .
METHODS	Reaction-times and accuracies were recorded during an n-back task .
METHODS	Moreover , regional blood oxygenated level-dependent ( BOLD ) response was measured during this task and during smoking cue exposure .
RESULTS	Greater activation was found in response to smoking cues compared to neutral cues in bilateral trans-occipital sulcus ( P < 0.005 ) ; however , this effect did not survive correction for multiple comparisons .
RESULTS	There was no difference in brain activity to smoking cues between the treatment groups and no effects of acute nicotine challenge were established .
RESULTS	For the n-back task we found working memory load-sensitive increases in brain activity in several frontal and parietal areas ( P < 0.0025 ) .
RESULTS	However , no effects of immunization or nicotine challenge were observed .
CONCLUSIONS	No significant effects of immunization on brain activity in response to a nicotine challenge were established .
CONCLUSIONS	Therefore this vaccine is not likely to be an effective aid in smoking cessation .

###24765629
OBJECTIVE	The aim of the present study was to evaluate three mouth rinse solutions ' ( Plax , Listerine and Periogard ) influence on the microhardness and color stability of a composite resin ( Esthet.X , Dentsply ) .
METHODS	For this purpose , forty specimens were prepared , being 10 specimens for each solution and 10 for artificial saliva ( control group ) .
METHODS	Initially , specimens were polished and immersed in artificial saliva and following the initial color , an evaluation was made .
METHODS	For 30 days , specimens were immersed in the solutions three times a day for 1 min .
METHODS	After this cycling period , color change was analyzed and Knoop microhardness measures were carried out .
METHODS	A new color measurement was performed after repolishing the specimens .
RESULTS	The microhardness and color stability results showed no statistically significant difference among the studied solutions .
RESULTS	However , samples immersed in Periogard showed a significant alteration in the composite resin brightness test .
CONCLUSIONS	It can be concluded that mouth rinse can influence the luminosity of composite resin .

###25092356
OBJECTIVE	To evaluate short-term perineal pain among primiparous women after mediolateral episiotomy ( MLE ) and lateral episiotomy ( LE ) .
METHODS	The prospective randomized study was conducted in the Czech Republic during 2010-2012 .
METHODS	Consecutive primiparous women who gave birth at or after 37 weeks of pregnancy and had indications for an episiotomy were enrolled and randomly assigned to undergo MLE or LE .
METHODS	Patients were unaware of the episiotomy type performed .
METHODS	The primary outcomes were pain at 24 hours , 72 hours , and 10 days post partum , measured by a visual analog scale , verbal rating scale , interference with activities of daily living , and amount of analgesic use .
RESULTS	The analysis included 266 women who underwent MLE and 297 women who underwent LE .
RESULTS	Complete relief of pain was observed in 6 ( 2.3 % ) of 266 women after 24 hours , 21 ( 8.0 % ) of 264 after 72 hours , and 77 ( 29.1 % ) of 265 after 10 days in the MLE group , and in 11 ( 3.9 % ) of 285 , 23 ( 7.7 % ) of 297 , and 78 ( 26.4 % ) of 295 in the LE group , respectively ( P = 0.36 ) .
RESULTS	There were no significant differences in overall pain scores from any rating system or in the amount of analgesics used .
CONCLUSIONS	Incidence and extent of pain in the first 10 days after LE correspond to those after adequately performed MLE .

###24981366
BACKGROUND	Preterm birth is the most important single determinant of adverse outcome in the United Kingdom ; one in every 70 babies ( 1.4 % ) is born before 32weeks ( very preterm ) , yet these births account for over half of infant deaths.Deferring cord clamping allows blood flow between baby and placenta to continue for a short time .
BACKGROUND	This often leads to increased neonatal blood volume at birth and may allow longer for transition to the neonatal circulation .
BACKGROUND	Optimal timing for clamping the cord remains uncertain , however .
BACKGROUND	The Cochrane Review suggests that deferring umbilical cord clamping for preterm births may improve outcome , but larger studies reporting substantive outcomes and with long-term follow-up are needed .
BACKGROUND	Studies of the physiology of placental transfusion suggest that flow in the umbilical cord at very preterm birth may continue for several minutes .
BACKGROUND	This pilot trial aims to assess the feasibility of conducting a large randomised trial comparing immediate and deferred cord clamping in the UK .
METHODS	Women are eligible for the trial if they are expected to have a live birth before 32weeks gestation .
METHODS	Exclusion criteria are known monochorionic twins or clinical evidence of twin-twin transfusion syndrome , triplet or higher order multiple pregnancy , and known major congenital malformation .
METHODS	The interventions will be cord clamping within 20seconds compared with cord clamping after at least two minutes .
METHODS	For births with cord clamping after at least two minutes , initial neonatal care is at the bedside .
METHODS	For the pilot trial , outcomes include measures of recruitment , compliance with the intervention , retention of participants and data quality for the clinical outcomes.Information about the trial is available to women during their antenatal care .
METHODS	Women considered likely to have a very preterm birth are approached for informed consent .
METHODS	Randomisation is close to the time of birth .
METHODS	Follow-up for the women is for one year , and for the children to two years of age ( corrected for gestation at birth ) .
METHODS	The target sample size is 100 to 110 mother-infant pairs recruited over 12months at eight sites .
BACKGROUND	ISRCTN21456601 , registered on 28 February 2013 .

###24614829
OBJECTIVE	Exercises aiming to strengthen the upper extremities are recommended to increase activities of daily living ( ADLs ) in patients with spinal cord injury ( SCI ) .
OBJECTIVE	The aim of this study was to compare the effects of upper extremity progressive resistance exercises ( PRE ) and endurance exercises ( EE ) performed with an arm ergometer in patients with paraplegia due to SCI .
METHODS	A total of 19 SCI patients were included in the study , and randomly divided into two groups .
METHODS	The first group performed PRE while the second group performed arm EE .
METHODS	The functional independence measurement ( FIM ) was used on each patient at the beginning and at the end of the study .
METHODS	The elbow flexion and extension muscle strengths of each patient were determined with the computerized isokinetic dynamometer at the beginning and end of the study .
RESULTS	Post-training increased the FIM scores in both PRE ( p = 0.005 ) and EE groups ( p = 0.008 ) .
RESULTS	There were increases in the extension peak torque ( PT ) and total work ( TW ) at 180/sec and 60/sec angular velocity in the PRE group compared to the EE group ( all p < 0.05 ) .
CONCLUSIONS	There were improvement in post-training muscle strength values in both the PRE ( found to be more effective ) and EE groups .
METHODS	Randomized trial ( Level I ) .

###24818952
OBJECTIVE	In the TRial to assess Improvement in Therapeutic Outcomes by optimizing platelet inhibitioN with prasugrel Thrombolysis In Myocardial Infarction 38 ( TRITON-TIMI 38 ) , prasugrel reduced the primary ischaemic endpoint as compared with clopidogrel in acute coronary syndrome ( ACS ) patients planned to undergo percutaneous coronary interventions , but increased the risk of bleeding .
OBJECTIVE	The present analysis shows the efficacy and safety data for the 10,074 non-ST segment elevation ( NSTE ) - ACS patients included in that trial .
RESULTS	The primary endpoint was significantly reduced by prasugrel in the overall NSTE-ACS population ( hazard ratio ( HR ) 0.82 , 95 % confidence interval ( CI ) 0.73-0 .93 , p = 0.002 ) as well as in unstable angina ( UA ) and in non-ST elevation myocardial infarction ( NSTEMI ) patient subgroups ( interaction p value = 0.39 ) .
RESULTS	Although non-coronary artery bypass graft ( CABG ) TIMI major bleeding was increased with prasugrel as compared with clopidogrel ( HR 1.40 , 95 % CI 1.05-1 .88 , p = 0.02 ) , there was a net clinical benefit in patients assigned to prasugrel ( HR 0.89 , 95 % CI 0.80-1 .00 , p = 0.043 ) , which was consistent for UA and NSTEMI subgroups ( interaction p value = 0.84 and 0.72 ) .
RESULTS	In patients who met the criteria for prasugrel use recommended by the European Medicines Agency , thus excluding from the analysis patients with prior transient ischemic attack ( TIA ) / stroke , with weight < 60 kg or age 75 years , and censoring follow-up at 365 days , ( European Union ( EU ) - label cohort ) prasugrel showed superiority over clopidogrel with regard to the primary endpoint ( HR 0.73 , 95 % CI 0.63-0 .85 , p < 0.0001 ) for the entire NSTE-ACS population , as well as for UA patients and NSTEMI patients without significant differences in non-CABG TIMI major bleeding .
CONCLUSIONS	Prasugrel , as compared with clopidogrel , significantly reduced the primary endpoint of the TRITON-TIMI 38 trial in NSTE-ACS patients , as well as in the UA and NSTEMI groups .
CONCLUSIONS	A significant reduction in the primary endpoint without increased bleeding was observed in the EU-label cohort .

###25187002
OBJECTIVE	ANTHEM-HF evaluated a novel autonomic regulation therapy ( ART ) via either left or right vagus nerve stimulation ( VNS ) in patients with heart failure ( HF ) and reduced ejection fraction ( HFrEF ) .
RESULTS	Sixty subjects ( New York Heart Association [ NYHA ] functional class II-III , left ventricular ejection fraction ( LVEF ) 40 % , left ventricular end-diastolic diameter 50 mm to < 80 mm ) receiving optimal pharmacologic therapy were randomized at 10 sites .
RESULTS	VNS systems were randomly implanted on the left ( n = 31 ) or right ( n = 29 ) side .
RESULTS	All patients were successfully implanted and 59 were titrated over 10 weeks to a well tolerated stimulation intensity .
RESULTS	One patient died 3 days after an embolic stroke that occurred during implantation .
RESULTS	Common device-related adverse events after VNS titration were transient mild dysphonia , cough , and oropharyngeal pain , which were similar for left - and right-side VNS .
RESULTS	After 6 months of ART , the adjusted left-right differences in LVEF , left ventricular end-systolic volume ( LVESV ) , and left ventricular end-systolic diameter ( LVESD ) were 0.2 % ( 95 % CI -4.4 to 4.7 ) , 3.7 mL ( 95 % CI -7.0 to 14.4 ) , and 1.3 mm ( 95 % CI -0.9 to 3.6 ) , respectively .
RESULTS	In the combined population , absolute LVEF improved by 4.5 % ( 95 % CI 2.4-6 .6 ) , LVESV improved by -4.1 mL ( 95 % CI -9.0 to 0.8 ) , and LVESD improved by -1.7 mm ( 95 % CI -2.8 to -0.7 ) .
RESULTS	Heart rate variability improved by 17 ms ( 95 % CI 6.5-28 ) with minimal left-right difference .
RESULTS	Six-minute walk distance improved an average of 56 m ( 95 % CI 37-75 ) ; however , improvement was greater for right-side ART ( 77 m [ 95 % CI 49-105 ] ) .
RESULTS	NYHA functional class improved in 77 % of patients ( baseline to 6 months ) .
CONCLUSIONS	Chronic open-loop ART via left - or right-side VNS is feasible and well tolerated in HFrEF patients .
CONCLUSIONS	Safety and efficacy measures are encouraging and warrant further study .

###25183453
OBJECTIVE	Moderate alcohol consumption exerts a cardioprotective effect , but no studies have evaluated the alcohol-independent cardiovascular effects of the non-alcoholic components of beer .
OBJECTIVE	We aimed to evaluate the effects of ethanol and the phenolic compounds of beer on classical and novel cardiovascular risk factors .
RESULTS	Thirty-three high risk male volunteers were included in a randomized , crossover feeding trial .
RESULTS	After a washout period , all subjects received beer ( 30 g alcohol/d , 660 mL ) , the equivalent amount of polyphenols as non-alcoholic beer ( 990 mL ) , and gin ( 30 g alcohol/d , 100 mL ) for 4 weeks .
RESULTS	All outcomes were evaluated before and after each intervention period .
RESULTS	Moderate alcohol consumption increased serum HDL-cholesterol ( 5 % ) , ApoA-I ( 6 % ) , ApoA-II ( 7 % ) and adiponectin ( 7 % ) , and decreased serum fibrinogen ( 8 % ) , and interleukin ( IL ) -5 ( 14 % ) concentrations , whereas the non-alcoholic fraction of beer ( mainly polyphenols ) increased the receptor antagonist of IL-1 ( 24 % ) , and decreased lymphocyte expression of lymphocyte function-associated antigen-1 ( 11 % ) , lymphocyte and monocyte expression of Sialil-Lewis X ( 16 % ) and monocyte expression of CCR2 ( 31 % ) , and tumor necrosis factor ( TNF ) - ( 14 % ) and IL-15 ( 22 % ) plasma concentrations .
RESULTS	No changes were observed in glucose metabolism parameters or in body weight and adiposity parameters .
CONCLUSIONS	The phenolic content of beer reduces leukocyte adhesion molecules and inflammatory biomarkers , whereas alcohol mainly improves the lipid profile and reduces some plasma inflammatory biomarkers related to atherosclerosis .

###25764287
BACKGROUND	Defaecatory function is often poor after anterior resection .
BACKGROUND	Denervation of the neorectum following high ligation of the inferior mesenteric artery ( IMA ) is a possible cause of impaired defaecatory function .
BACKGROUND	The purpose of this randomized clinical trial was to clarify whether the level of ligation of the IMA in patients with rectal cancer affects defaecatory function .
METHODS	Between 2008 and 2011 , patients who underwent anterior resection for rectal cancer were randomized to receive either high or low ligation of the IMA .
METHODS	The primary endpoint was to demonstrate the superiority of low ligation in terms of defaecatory function .
RESULTS	One hundred patients were enrolled in the study ; 51 were randomized to high ligation of the IMA and 49 to low ligation .
RESULTS	There were no differences between the groups in terms of clinical data , except tumour stage , which was more advanced in the high-ligation group ( P = 0046 ) .
RESULTS	Nor were there any differences in defaecatory function , self-assessment of defaecation , Faecal Incontinence Quality of Life scale or continence score between groups at 3months and 1year .
RESULTS	The number of harvested lymph nodes was similar .
RESULTS	The rate of symptomatic anastomotic leakage was 16 per cent in the high-ligation group and 10 per cent in the low-ligation group ( P = 0415 ) .
CONCLUSIONS	The level of ligation of the IMA in patients with rectal cancer did not affect defaecatory function or the incidence of postoperative complications .
BACKGROUND	NCT00701012 ( http://www.clinicaltrials.gov ) .

###25190230
BACKGROUND	A high percentage of biventricular pacing is required for optimal outcome in patients treated with cardiac resynchronization therapy ( CRT ) , but the influence of ectopic beats on the success of biventricular pacing has not been well established .
OBJECTIVE	This study sought to determine if increased ectopic beats reduce the chance of high biventricular pacing percentage and are associated with subsequent adverse outcomes .
METHODS	From the MADIT-CRT ( Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy ) , 801 patients with an implanted CRT-defibrillator device with data available on biventricular pacing percentage and pre-implantation 24-h Holter recordings were included .
METHODS	Using logistic regression , we estimated the influence of ectopic beats on the percentage of biventricular pacing .
METHODS	Reverse remodeling was measured as reductions in atrial and left ventricular end-systolic volumes ( LVESV ) at 1 year .
METHODS	Cox models were used to assess the influence of ectopic beats on the outcomes of heart failure ( HF ) or death , ventricular tachyarrhythmias ( VTAs ) , and death .
RESULTS	In the pre-implantation Holter recording , ectopic beats accounted for a mean 3.2 5.5 % of all beats .
RESULTS	The probability of subsequent low biventricular pacing percentage ( < 97 % ) was increased 3-fold ( odds ratio : 3.37 ; 95 % confidence interval : 1.74 to 6.50 ; p < 0.001 ) in patients with 0.1 % to 1.5 % ectopic beats and 13-fold ( odds ratio : 13.42 ; 95 % confidence interval : 7.02 to 25.66 ; p < 0.001 ) in patients with > 1.5 % ectopic beats compared with those with < 0.1 % ectopic beats .
RESULTS	Patients with 0.1 % ectopic beats had significantly less reverse remodeling ( percent reduction in LVESV 31 15 % ) than patients with < 0.1 % ectopic beats ( percent reduction in LVESV 39 14 % ; p < 0.001 ) .
RESULTS	The risk of HF/death and VTA was increased significantly in those with 0.1 % to 1.5 % ectopic beats ( hazard ratio : 3.13 and 1.84 , respectively ) and for > 1.5 % ectopic beats ( hazard ratio : 2.38 and 2.74 , respectively ) .
CONCLUSIONS	Relatively low frequencies of ectopic beats ( 0.1 % ) dramatically increase the probability of low biventricular pacing ( < 97 % ) , with reduced CRT efficacy by less reverse remodeling and higher risk of HF/death and VTA .
CONCLUSIONS	This supports pre-implantation Holter monitoring of patients selected for CRT for optimal outcome .
CONCLUSIONS	( MADIT-CRT : Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy ; NCT00180271 ) .

###25214778
BACKGROUND	Indacaterol 75 g once daily is a long-acting 2 agonist approved for maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease ( COPD ) .
BACKGROUND	The purpose of this study was to evaluate patients ' perception of onset of effect with a single dose .
METHODS	In this double-blind , crossover , Phase IV study , 40 patients were randomized to receive a single dose of indacaterol 75 g or placebo via a dry powder inhaler device .
METHODS	The primary variable was time until patient 's perception of onset of effect , using a simple self-administered ( nonvalidated ) questionnaire that patients answered at nine protocol-specified time points .
METHODS	Exploratory variables included change in forced expiratory volume in 1 second ( FEV1 ) and change in percent predicted FEV1 from predose to postdose ( determined 60-75 minutes postdose ) .
RESULTS	The least-squares mean time to patient 's perception of onset of effect was 25.4 minutes and 23.9 minutes for indacaterol and placebo , respectively .
RESULTS	There was no significant effect for treatment , period , or sequence on the time to patient 's perception .
RESULTS	In addition , no statistically significant differences between treatments were observed for patient 's global satisfaction with onset of effect and global expectation of treatment adherence .
RESULTS	For the exploratory variable change in FEV1 from predose to postdose , indacaterol showed superiority over placebo with a clinically relevant least-squares mean treatment difference of 0.12 L ( P < 0.0001 ) .
RESULTS	There was little or no association between patient 's perception of time to onset of effect and change in FEV1 , or change in percent predicted FEV1 .
RESULTS	Both treatments were well tolerated .
CONCLUSIONS	A single dose of indacaterol 75 g did not separate from placebo in terms of patient perception of onset , although there was an improvement in FEV1 for indacaterol compared with placebo .
CONCLUSIONS	Development and use of a validated questionnaire may be needed to address the inconsistency in evaluating this patient-related outcome .

###24837493
BACKGROUND	Injectable bulking treatment for fecal incontinence ( FI ) is intended to expand tissue in the anal canal and prevent fecal leakage .
BACKGROUND	Use of injectable bulking agents is increasing because it can be performed in an outpatient setting and with low risk for morbidity .
BACKGROUND	This study evaluated the long-term ( 36-month ) clinical effectiveness and safety of injection of non-animal stabilized hyaluronic acid/dextranomer ( NASHA Dx ) on FI symptoms .
METHODS	In a prospective multicenter trial , 136 patients with FI received the NASHA Dx bulking agent .
METHODS	Treatment success defined as a reduction in number of FI episodes by 50 % or more compared with baseline ( Responder50 ) .
METHODS	Change from baseline in Cleveland Clinic Florida Fecal Incontinence Score ( CCFIS ) and Fecal Incontinence Quality of Life Scale ( FIQL ) , and adverse events were also evaluated .
RESULTS	Successful decrease in symptoms was achieved in 52 % of patients at 6months and this was sustained at 12months ( 57 % ) and 36months ( 52 % ) .
RESULTS	Mean CCFIS decreased from 14 at baseline to 11 at 36months ( p < 0.001 ) .
RESULTS	Quality-of-life scores for all four domains improved significantly between baseline and 36months of follow-up .
RESULTS	Severe adverse events were rare and most adverse events were transient and pertained to minor bleeding and pain or discomfort .
CONCLUSIONS	Submucosal injection of NASHA Dx provided a significant improvement of FI symptoms in a majority of patients and this effect was stable during the course of the follow-up and maintained for 3years .

###24920862
OBJECTIVE	We sought to examine the prevalence of EEG abnormalities in Smith-Lemli-Opitz syndrome ( SLOS ) as well as the relationship between interictal epileptiform discharges ( IEDs ) and within-subject variations in attentional symptom severity .
METHODS	In the context of a clinical trial for SLOS , we performed cross-sectional and repeated-measure observational studies of the relationship between EEG findings and cognitive/behavioral factors on 23 children ( aged 4-17 years ) .
METHODS	EEGs were reviewed for clinical abnormalities , including IEDs , by readers blinded to participants ' behavioral symptoms .
METHODS	Between-group differences in baseline characteristics of participants with and without IEDs were analyzed .
METHODS	Within-subject analyses examined the association between the presence of IEDs and changes in attention-deficit/hyperactivity disorder ( ADHD ) symptoms .
RESULTS	Of 85 EEGs , 43 ( 51 % ) were abnormal , predominantly because of IEDs .
RESULTS	Only one subject had documented clinical seizures .
RESULTS	IEDs clustered in 13 subjects ( 57 % ) , whereas 9 subjects ( 39 % ) had EEGs consistently free of IEDs .
RESULTS	While there were no significant group differences in sex , age , intellectual disability , language level , or baseline ADHD symptoms , autistic symptoms tended to be more prevalent in the `` IED '' group ( according to Autism Diagnostic Observation Schedule-2 criteria ) .
RESULTS	Within individuals , the presence of IEDs on a particular EEG predicted , on average , a 27 % increase in ADHD symptom severity .
CONCLUSIONS	Epileptiform discharges are common in SLOS , despite a relatively low prevalence of epilepsy .
CONCLUSIONS	Fluctuations in the presence of epileptiform discharges within individual children with a developmental disability syndrome may be associated with fluctuations in ADHD symptomatology , even in the absence of clinical seizures .

###24345602
OBJECTIVE	To describe the effectiveness , reach and implementation of a weight gain prevention intervention among public school employees .
METHODS	A multi-level intervention was tested in a cluster randomized trial among 782 employees in 12 central Massachusetts public high schools from 2009 to 2012 .
METHODS	The intervention targeted the nutrition and physical activity environment and policies , the social environment and individual knowledge , attitudes and skills .
METHODS	The intervention was compared to a materials only condition .
METHODS	The primary outcome measures were change in weight and body mass index ( BMI ) at 24-month follow-up .
METHODS	Implementation of physical environment , policy and social environment strategies at the school and interpersonal levels , and intervention participation at the individual level were assessed .
RESULTS	At 24-month follow-up , there was a net change ( difference of the difference ) of -3.03 pounds ( p = .04 ) and of -.48 BMI units ( p = .05 ) between intervention and comparison conditions .
RESULTS	The majority of intervention strategies were successfully implemented by all intervention schools , although establishing formal policies was challenging .
RESULTS	Employee participation in programs targeting the physical and social environment was maintained over time .
CONCLUSIONS	This study supports that a multi-level intervention integrated within the organizational culture can be successfully implemented and prevent weight gain in public high school employees .

###24832687
BACKGROUND	It is important to engage patients and surrogates in conversations about goals and preferences for medical treatment before high-risk surgery .
BACKGROUND	However , few interventions have been tested to facilitate these discussions .
OBJECTIVE	To assess the acceptability and feasibility of a facilitated , structured conversation with patients and surrogates about patient goals and preferences for medical treatment during their visit to a preoperative testing center before high-risk surgery .
METHODS	A randomized controlled pilot study in the preoperative testing center at a tertiary academic hospital over a 4-month period .
METHODS	We used baseline and preoperative surveys to assess feasibility , and to compare differences in worry , surrogate burden , and patient-surrogate concordance about treatment preferences in conversation and control groups .
METHODS	We assessed acceptability of the conversation qualitatively and through surveys .
RESULTS	Of 146 eligible patients , 79 were approached , and 65 declined to participate .
RESULTS	Thirteen completed the study and 8 were randomized to the structured conversation .
RESULTS	Major recruitment barriers included lack of time , or surrogate unavailability .
RESULTS	Most postconversation patients were less worried , and more hopeful for a good recovery before surgery ; 7 of 8 would recommend the conversation .
RESULTS	Six of 8 surrogates reported postoperatively that the conversation helped prepare them to be a surrogate .
RESULTS	Concordance improved in the intervention group only .
CONCLUSIONS	Current processes of care present major barriers to conducting facilitated conversations in the preoperative testing center .
CONCLUSIONS	Among a small group of patients and surrogates , most found a structured conversation about the patient 's goals and preferences for medical treatment helpful before high-risk surgery .

###24709170
BACKGROUND	Transradial approach catheterization is now widely used in coronary angiography and angioplasty .
BACKGROUND	The ulnar artery , which is one of the two terminal branches of the brachial artery , may be a potential approach for cardiac catheterization .
BACKGROUND	The aim of this study was to evaluate the safety and feasibility of a transulnar approach for coronary catheterization in non-selective patients .
METHODS	A total of 535 consecutive patients were randomly assigned to transulnar approach ( TUA ) group ( n = 271 ) or transradial approach ( TRA ) group ( n = 264 ) upon arrival at the catheterization laboratory .
METHODS	Allen 's test and inverse Allen 's test were not routinely performed .
METHODS	Ultrasound-Doppler assessment of the forearm artery was performed before the procedure , two days after the procedure , and 30 days after the procedure .
METHODS	The primary endpoints of study were the rate of successful artery cannulation and the access-site related complications .
METHODS	The secondary endpoints included the number of needle punctures , total time for the procedure , and major adverse cardiac events ( MACE ) .
RESULTS	Successful puncture of the objective artery was obtained in 91.5 % of the patients in the TUA group , and 95.1 % of the patients in the TRA group ( P > 0.05 ) .
RESULTS	There was no significant difference in hematoma complications between the two groups ( 7.7 % vs. 4.2 % , P = 0.100 ) .
RESULTS	A motor abnormality of the hand was observed in one patient in the TUA group .
RESULTS	There were no arteriovenous fistula or pseudoaneurysm observed in our study .
RESULTS	Three ( 1.1 % ) patients in the TUA group and 8 ( 3.0 % ) patients in the TRA group had occlusion of the access artery ( P = 0.137 ) , but none of the patients had symptoms or signs of hand ischemia .
RESULTS	There were no significant differences in MACE between the two groups during follow-up .
CONCLUSIONS	The transulnar approach is an effective and safe technique for coronary catheterization in non-selective patients .

###25703461
OBJECTIVE	To evaluate the feasibility of a 100 kVp tube voltage combined with an iterative reconstruction algorithm in retrospective electrocardiogram ( ECG ) - gated thoracoabdominal aortic CT angiography ( CTA ) .
METHODS	Ninety-eight patients who underwent clinically indicated thoracoabdominal aortic CTA were randomly assigned to two groups : group A ( n = 50 ) were scanned to 120 kVp and group B ( n = 48 ) to 100 kVp .
METHODS	The body mass index of all included patients was < 25 kg/m ( 2 ) .
METHODS	Group A scans were reconstructed with a standard filtered back projection ( FBP ) algorithm , and group B scans with FBP , iDose , and non-tagged algorithms .
METHODS	Data comparison between groups was performed using t-test and analysis of variance .
RESULTS	Compared with group A , the iDose algorithm in group B yielded a higher contrast-to-noise ratio ( CNR ; 48.1 10.1 , p < 0.05 ) , a higher signal-to-noise ratio ( SNR ; 13.8 5.4 , p < 0.05 ) , and a lower standard deviation ( SD ; 30.3 6.9 , p < 0.05 ) .
RESULTS	The subjective score of iDose reconstructions from group B was significantly lower than that of FBP reconstruction from group A ( p < 0.05 ) .
RESULTS	In group B , the non-tagged algorithm resulted in a higher CNR and a higher SNR , but a higher SD and a higher subjective score than did the iDose algorithm .
RESULTS	The average effective dose for group B was 35.8 % lower than that for group A.
CONCLUSIONS	A combination of a 100 kVp tube voltage and the iDose algorithm can help to improve image quality and reduce radiation dose in retrospective ECG-gated thoracoabdominal aortic CTA .

###25577661
BACKGROUND	The use of different limbs for the administration of sequential doses of an intradermal rabies vaccine was shown to result in reduced vaccine immunogenicity .
BACKGROUND	We aimed to assess whether this phenomenon also occurs with routine infant vaccines .
METHODS	In this open-label , randomised , controlled study , eligible healthy infants 6-12 weeks of age recruited through five clinical trials units ( four in the UK and one in Malta ) were randomly assigned in a 1:1 ratio to two vaccination groups : consistent limb or alternating limb .
METHODS	Infants in the consistent limb group received the diphtheria-tetanus-acellular pertussis-inactived polio-Haemophilus influenzae type b combined vaccine ( DTaP-IPV-Hib ) at 2 , 3 , and 4 months of age , and the pneumococcal conjugate vaccine ( PCV13 ) at 2 , 4 , and 12 months , all administered to the right leg .
METHODS	Infants in the alternating limb group received DTaP-IPV-Hib in the left leg at 2 months and in the right leg at 3 and 4 months ; and PCV13 in the left leg at 2 months , in the right leg at 4 months , and in the left arm at 12 months .
METHODS	All infants in both groups received the combined H influenzae type b and capsular group C Neisseria meningitidis tetanus toxoid conjugate vaccine ( Hib-MenC-TT ) , administered in the left leg at 12 months .
METHODS	Randomisation was achieved by randomly generated codes , with permuted block size of 30 , and was stratified by study site .
METHODS	Group allocation was not masked from study staff and parents of participants after enrolment , but group allocation was masked from laboratory staff assessing blood samples .
METHODS	The current study was a prespecified secondary objective of a parent phase 4 trial that assessed the induction of immunity following varying schedules of vaccination with glyco-conjugate capsular group C Neisseria meningitidis ( Men C ) vaccines in infancy .
METHODS	The objective of the current study was to compare the immunogenicity and reactogenicity of vaccines delivered in either consistent or alternating limbs .
METHODS	Immunogenicity was assessed by comparing serum IgG geometric mean concentrations at 5 , 12 , 13 , and 24 months , analysed per protocol .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01129518 .
RESULTS	Between July 5 , 2010 , and Aug 1 , 2013 , we enrolled 509 infants and randomly allocated them to the consistent limb group ( n = 254 ) or the alternating limb group ( n = 255 ) .
RESULTS	Anti-H influenzae type b anti-polyribosylribitol phosphate IgG geometric mean concentrations were lower in the consistent limb group than in the alternating limb group at 5 months ( consistent limb 041 g/mL [ 95 % CI 031-054 ] vs alternating limb 061 g/mL [ 045-082 ] ; p = 00268 ) and at 12 months ( 035 g/mL [ 028-043 ] vs 050 g/mL [ 040-062 ] ; p = 00136 ) .
RESULTS	Anti-tetanus toxoid antibody IgG geometric mean concentrations were lower in the consistent limb group ( 163 IU/mL [ 95 % CI 140-190 ] ) than in the alternating limb group ( 230 IU/mL [ 197-268 ] ) at 13 months ( p = 00008 ) and at 24 months ( 044 IU/mL [ 037-052 ] vs 061 IU/mL [ 051-073 ] ; p = 00074 ) .
RESULTS	Anti-pneumococcal IgG geometric mean concentrations were similar between both groups at all timepoints .
RESULTS	The proportions of participants who had adverse events did not differ between the two groups .
CONCLUSIONS	Use of different ( alternating ) limbs for sequential doses of routine infant vaccines does not reduce , and might enhance , immunogenicity .
CONCLUSIONS	The underlying mechanism for this finding warrants further research .
BACKGROUND	NIHR Oxford Biomedical Research Centre and GlaxoSmithKline Biologicals .

###25775741
BACKGROUND	Most minor hand operations can be performed with local anesthesia and tourniquet .
BACKGROUND	Some literature supports this concept based on the believe that the `` patient can tolerate it '' .
BACKGROUND	Nowadays , the wide-awake technique with epinephrine - contained lidocaine is safe .
BACKGROUND	This technique does not need a tourniquet because epinephrine provides local vasoconstriction .
OBJECTIVE	The present study was designed to compare patients ' comfort and effectiveness of local anesthesia as well as bleeding at the surgical site between wide-awake anesthesia and local lidocaine with tourniquet application .
METHODS	Prospective Clinical Trial was performed in 60 patients who received outpatient surgery for common hand problems at Maharaj Nakorn Chiang Mai Hospital .
METHODS	With randomization , 30 patients were in wide-awake group , who received adrenaline-contained lidocaine as a local anesthetic agent , with tourniquet wrapping but with no pressure applied ( group 1 ) .
METHODS	The other 30 patients were in the conventional group that received lidocaine ( no adrenaline ) and a 250-mmHg tourniquet application ( group 2 ) .
METHODS	Operations were performed with standard methods .
METHODS	Visual analog scores , surgical field bleeding , amount of bleeding , any complications within 4 weeks were recorded .
RESULTS	There are no significant differences between the two groups in terms of patient profiles ( sex , age and diseases ) , injected site pain and surgeon 's opinion of surgical site bleeding .
RESULTS	Tourniquet 's pain and the amount of blood loss in the conventional group were significantly higher than the wide-awake group .
CONCLUSIONS	Wide-awake technique ( no tourniquet applied ) offers better comfort for patients and less total blood loss while providing effective anesthesia and patient safety as with the conventional technique .

###25831603
OBJECTIVE	To evaluate if the intake of a fluoridated food supplement in breastfeeding mothers increases the fluoride concentration in breast milk .
METHODS	A double-blind randomized placebo-controlled study was designed .
METHODS	Two groups of women were formed : a fluoride group ( n = 112 ) , using a non-sucrose food supplement containing fluoride ( 1,500 g/l for each dose ) and a control group ( n = 116 ) , using a non-sucrose food supplement without fluoride content .
METHODS	The women were followed for 6 weeks .
METHODS	Samples of breast milk were collected and analyzed using an ion-specific electrode .
RESULTS	85 women in the fluoride group and 83 in the control group concluded the trial .
RESULTS	Fluoride concentrations in the two groups were statistically significantly different ( 515 g/l in the fluoride and 476 g/l in the control group P = 0.04 ) at the end of the experimental period .
RESULTS	In the fluoride group , a statistically significant increment in fluoride concentration during the experimental period was also observed ( from 468 104 g/l to 515 105 g/l ) .
RESULTS	The use of a non-sucrose food supplement containing fluoride resulted in a significant increment in fluoride concentration in breast milk .

###25037455
BACKGROUND	Research investigating the effectiveness of universal interventions to reduce the risk of mental health problems remains limited .
BACKGROUND	Schools are a promising setting within which adolescents can receive interventions aimed at promoting their mental health .
BACKGROUND	The aim of this study is to assess the effectiveness of a resilience-based prevention-focused intervention in reducing the risk of mental health problems among adolescents attending secondary school in socio-economically disadvantaged areas .
METHODS	A cluster randomised control trial will be conducted , with schools as the unit of randomisation .
METHODS	Initially , 32 secondary schools will be randomly allocated to a control or intervention group ( 12 control and 20 intervention ) .
METHODS	An intervention focused on improving student internal and external resilience factors will be implemented in intervention schools .
METHODS	A survey of students in Grade 7 in both intervention and control schools will be conducted ( baseline ) and repeated three years later when the students are in Grade 10 .
METHODS	The Strengths and Difficulties Questionnaire will be used to measure the risk of mental health problems .
METHODS	At follow-up , the risk of mental health problems will be compared between Grade 10 students in intervention and control schools to determine intervention effectiveness .
CONCLUSIONS	The study presents an opportunity to determine the effectiveness of a comprehensive resilience-based intervention in reducing the risk of mental health problems in adolescents attending secondary schools .
CONCLUSIONS	The outcomes of the trial are of importance to youth , schools , mental health clinicians and policymakers .
BACKGROUND	Australian New Zealand Clinical Trials Registry , ACTRN12611000606987 , registered 14 June 2011 .

###26179672
BACKGROUND	Seroma formation , the most prevalent postoperative complication after mastectomy , is an inflammatory process that is potentially preventable via local steroid administration .
BACKGROUND	This study investigated the effect of local steroid administration on seroma formation .
METHODS	This was a double-blind randomized placebo-controlled intervention study of a single dose of 80 mg methylprednisolone versus saline on seroma formation after mastectomy .
METHODS	Patients were further classified according to the surgical axillary procedure : mastectomy with sentinel lymph node biopsy ( M + SLNB ) or mastectomy with level I-II axillary lymph node dissection ( M + ALND ) .
METHODS	Treatments were administered into the wound cavity via the drain orifice following removal of the drain on the first day after surgery .
METHODS	The primary endpoint was seroma formation ; secondary endpoints included the frequency of side-effects and complications .
RESULTS	A total of 212 women scheduled for mastectomy for primary breast cancer were included .
RESULTS	After M + SLNB , 32 ( 46 per cent ) of 69 women developed a seroma in the methylprednisolone group , compared with 52 ( 78 per cent ) of 67 in the saline group ( P < 0.001 ) .
RESULTS	The mean cumulative seroma volume in the intention-to-treat population for the first 10 and 30 days was significantly lower in the methylprednisolone group ( 24 ml versus 127 ml in the saline group , and 177 versus 328 ml respectively ) ( P < 0.001 ) .
RESULTS	After M + ALND , similar proportions of patients developed a seroma in the methylprednisolone ( 35 of 37 , 95 per cent ) and saline ( 34 of 36 , 94 per cent ) groups , and methylprednisolone administration had no significant effect on seroma formation .
RESULTS	No differences in infection rate were observed .
CONCLUSIONS	Methylprednisolone administered into the wound cavity on the first day after M + SLNB exerted a highly significant preventive effect against seroma formation during the next 30 days .
CONCLUSIONS	This effect was not seen in the M + ALND group .
CONCLUSIONS	Future studies may clarify whether higher or repeated methylprednisolone doses increase the efficacy .

###24447503
OBJECTIVE	To test the effects of pressure-controlled ( PCV ) and volume-controlled ( VCV ) ventilation during one-lung ventilation ( OLV ) for thoracic surgery on right ventricular ( RV ) function .
METHODS	A prospective , randomized , double-blind , controlled , crossover study .
METHODS	A single university hospital .
METHODS	Fourteen pairs of consecutive patients scheduled for elective thoracotomy .
METHODS	Patients were assigned randomly to ventilate the dependent lung with PCV or VCV mode , each in a randomized crossover order using tidal volume of 6 mL/kg , I : E ratio 1 : 2.5 , positive end-expiratory pressure ( PEEP ) of 5 cm H2O and respiratory rate adjusted to maintain normocapnia .
RESULTS	Intraoperative changes in RV function ( systolic and early diastolic tricuspid annular velocity ( TAV ) , end-systolic volume ( ESV ) , end-diastolic volume ( EDV ) and fractional area changes ( FAC ) ) , airway pressures , compliance and oxygenation index were recorded .
RESULTS	The use of PCV during OLV resulted in faster systolic ( 10.12.39 vs. 5.81.67 cm/s , respectively ) , diastolic TAV ( 9.21.99 vs. 4.61.42 cm/s , respectively ) ( p < 0.001 ) and compliance and lower ESV , EDV and airway pressures ( p < 0.05 ) than during the use of VCV .
RESULTS	Oxygenation indices were similar during the use of VCV and PCV .
CONCLUSIONS	The use of PCV offers more improved RV function than the use of VCV during OLV for open thoracotomy .
CONCLUSIONS	These results apply specifically to younger patients with good ventricular and pulmonary functions .

###24235073
BACKGROUND	Middle molecular weight uraemic toxins are considered to play an important role in vascular dysfunction and cardiovascular outcomes in end-stage renal disease ( ESRD ) patients .
BACKGROUND	Recent dialysis techniques based on convection , specifically high-efficiency on-line haemodiafiltration ( HDF ) , enhance the removal of middle molecular weight toxins and reduce all-cause mortality in haemodialysis ( HD ) patients .
BACKGROUND	However , the mechanisms of these improved outcomes remain to be established .
METHODS	This prospective study randomly assigned 42 ESRD patients to switch from high-flux HD to high-efficiency on-line HDF ( n = 22 ) or to continue HD ( n = 20 ) .
METHODS	Brachial artery endothelium-dependent flow-mediated dilatation , central pulse pressure , carotid artery intima-media thickness ( IMT ) , internal diastolic diameter and distensibility and circulating markers of uraemia , inflammation and oxidative stress were blindly assessed before and after a 4-month follow-up .
RESULTS	Brachial flow-mediated dilatation and carotid artery distensibility increased significantly in the HDF group compared with HD , while carotid IMT and diameter remained similar .
RESULTS	HDF decreased predialysis levels of the uraemic toxins 2-microglobulin , phosphate and blood TNF mRNA expression .
RESULTS	Oxidative stress markers were not different between the HD and HDF groups .
RESULTS	Blood mRNA expression of protein kinase C 2 , an endothelial NO-synthase ( eNOS ) inhibitor , decreased significantly with HDF .
CONCLUSIONS	High-efficiency on-line HDF prevents the endothelial dysfunction and stiffening of the conduit arteries in ESRD patients compared with high-flux HD .
CONCLUSIONS	HDF decreases uraemic toxins , vascular inflammation , and is associated with subsequent improvement in eNOS functionality .
CONCLUSIONS	These results suggest that reduced endothelial dysfunction may be an intermediate mechanism explaining the beneficial outcomes associated with HDF .

###25349264
BACKGROUND	Anatomic double-bundle anterior cruciate ligament ( ACL ) reconstruction provides excellent results for restoring normal kinematics to the knee .
BACKGROUND	Nevertheless , strong evidence supporting an ideal method for fixation of the ACL graft is lacking .
OBJECTIVE	Intratunnel femoral fixation of the ACL graft via a cross-pin fixation technique would provide better clinical and objective results than the extratunnel femoral fixation with cortical buttons .
METHODS	Randomized clinical trial ; Level of evidence , 2 .
METHODS	Seventy patients with a unilateral ACL-deficient knee were randomly assigned to 1 of 2 femoral fixation groups .
METHODS	Group A ( 35 patients ) was fixed with 2 bioabsorbable Rigidfix pins , 1 cross-pin per bundle , while group B ( 35 patients ) was secured with 1 EndoButton cortical button per bundle .
METHODS	All femoral tunnels were created via an anteromedial portal , and a bioabsorbable Biointrafix interference screw was used for tibial fixation for both groups .
METHODS	The evaluation of the patients was performed by history details , clinical examination findings , measurement of the joint laxity by KT-1000 arthrometer , and use of validated patient outcome questionnaires .
METHODS	Statistical analysis was carried out with Fisher exact and Mann-Whitney U tests , with P < .05 considered the cutoff level of significance .
RESULTS	At a mean follow-up of 30 months , 34 and 32 patients of group A and B , respectively , were available for evaluation .
RESULTS	There were no statistically significant differences between the treatment groups regarding the subjective and objective outcomes , except for KT-1000 arthrometer values .
RESULTS	The median KT-1000 value of patients in the cross-pin fixation group was 1.30 mm , while the median value in the cortical button fixation group was 1.95 mm ( P < .001 ) .
RESULTS	Four patients with ACL grafts that were fixed with cortical buttons demonstrated failure of stability via the instrumented knee laxity testing , while patients from the other group had no failures .
CONCLUSIONS	Intratunnel femoral fixation of the double-bundle ACL graft from the cross-pin fixation technique provided better instrumented knee laxity results than did the extratunnel femoral fixation with cortical buttons .
CONCLUSIONS	Future larger studies comparing these 2 techniques should be conducted to ensure the availability of stronger evidence supporting the findings of this study .

###25370359
OBJECTIVE	To compare results of obese patients with knee osteoarthritis ( OA ) who , after an intensive weight loss regimen , received 1 year of either dietary support ( D ) , a knee-exercise program ( E ) , or `` no attention '' ( C ; control group ) .
METHODS	We conducted a randomized , 2-phase , parallel-group trial .
METHODS	A total of 192 obese participants with knee OA were enrolled ; the mean age was 62.5 years and 81 % were women with a mean entry weight of 103.2 kg .
METHODS	In phase 1 , all participants were randomly assigned to 1 of 3 groups and began a dietary regimen of 400-810 and 1,250 kcal/day for 16 weeks ( 2 8-week phases ) to achieve a major weight loss .
METHODS	Phase 2 consisted of 52 weeks ' maintenance in either group D , E , or C. Outcomes were changes from randomization in pain on a 100-mm visual analog scale , weight , and response according to the Outcome Measures in Rheumatology-Osteoarthritis Research Society International criteria .
RESULTS	Mean weight loss for phase 1 was 12.8 kg .
RESULTS	After 1 year on maintenance therapy , the D group sustained a lower weight ( 11.0 kg , 95 % confidence interval [ 95 % CI ] 9.0 , 12.8 kg ) than those in the E ( 6.2 , 95 % CI 4.4 , 8.1 kg ) and C ( 8.2 , 95 % CI 6.4 , 10.1 kg ) groups ( P = 0.002 by analysis of covariance [ ANCOVA ] ) .
RESULTS	Adherence was low in the E group .
RESULTS	All groups had statistically significant pain reduction ( D : 6.1 ; E : 5.6 ; and C : 5.5 mm ) with no difference between groups ( P = 0.98 by ANCOVA ) .
RESULTS	In each group 32 ( 50 % ) , 26 ( 41 % ) , and 33 ( 52 % ) participants responded to treatment in the D , E , and C groups , respectively , with no statistically significant difference in the number of responders ( P = 0.41 ) .
CONCLUSIONS	A significant weight reduction with a 1-year maintenance program improves knee OA symptoms irrespective of maintenance program .

###26140524
OBJECTIVE	Perampanel , a selective , noncompetitive - amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid ( AMPA ) glutamate receptor antagonist , is indicated for adjunctive treatment of partial seizures in patients 12years based on three phase III clinical studies .
OBJECTIVE	The perampanel U.S. Prescribing Information includes a boxed warning for serious psychiatric and behavioral adverse reactions .
OBJECTIVE	To provide context for this warning , detail on psychiatric and behavioral safety data from perampanel clinical studies is presented .
METHODS	An analysis of pooled safety data from three phase III studies in patients with partial seizures is presented .
METHODS	Data from phase I and phase II studies in patients with and without epilepsy were also analyzed .
METHODS	Psychiatric and behavioral treatment-emergent adverse events ( TEAEs ) were evaluated according to Medical Dictionary for Regulatory Activities ( MedDRA ) terms , using `` narrow '' and `` narrow-and-broad '' standardized MedDRA queries ( SMQs ) for TEAEs suggestive of hostility/aggression .
RESULTS	From the three phase III partial-seizure studies , the overall rate of psychiatric TEAEs was higher in the 8mg ( 17.2 % ) and 12mg ( 22.4 % ) perampanel groups versus placebo ( 12.4 % ) .
RESULTS	In the `` narrow '' SMQ , hostility/aggression TEAEs were observed in 2.8 % for 8mg and 6.3 % for 12mg perampanel groups , versus 0.7 % of placebo patients .
RESULTS	`` Narrow-and-broad '' SMQs for hostility/aggression TEAE rates were 12.3 % for 8mg and 20.4 % for 12mg perampanel groups , versus 5.7 % for placebo ; rates for events resulting in discontinuation were perampanel = 1.6 % versus placebo = 0.7 % .
RESULTS	For events reported as serious AEs ( SAEs ) , rates were perampanel = 0.7 % versus placebo = 0.2 % .
RESULTS	In nonepilepsy patients , psychiatric TEAEs were similar between patients receiving perampanel and placebo .
RESULTS	In phase I subjects/volunteers , all psychiatric TEAEs were mild or moderate .
RESULTS	These analyses suggest that psychiatric adverse effects are associated with use of perampanel .
CONCLUSIONS	Patients and caregivers should be counseled regarding the potential risk of psychiatric and behavioral events with perampanel in patients with partial seizures ; patients should be monitored for these events during treatment , especially during titration and at higher doses .

###25373391
BACKGROUND	Less than 50 % of patients experience sufficient pain relief with current drug therapy for neuropathic pain .
BACKGROUND	Minocycline shows promising results in rodent models of neuropathic pain but was not studied in humans with regard to the treatment of neuropathic pain .
METHODS	In this randomized , double-blind , placebo-controlled clinical trial , patients with subacute lumbar radicular pain received placebo , amitriptyline 25 mg , or minocycline 100 mg once a day ( n = 20 per group ) for 14 days .
METHODS	Primary outcome measure was the pain intensity in the leg as measured by a numeric rating scale ranging from 0 to 10 on days 7 and 14 .
METHODS	Secondary outcome measures were the reduction of neuropathic pain symptoms in the leg as determined with a neuropathic pain questionnaire , consumption of rescue medication , and adverse events on days 7 and 14 .
RESULTS	Sixty patients were randomized and included in an intention-to-treat analysis .
RESULTS	After 14 days , patients in the minocycline and amitriptyline groups reported a reduction of 1.47 ( 95 % confidence interval , 0.16-2 .83 ; P = 0.035 ) and 1.41 ( 95 % confidence interval , 0.05-2 .78 ; P = 0.043 ) , respectively , in the numeric rating scale compared to the placebo group .
RESULTS	No differences were seen in the neuropathic pain questionnaire values at any time point during treatment between the three groups .
RESULTS	The rate of adverse events in the amitriptyline group was 10 % versus none in the minocycline and placebo groups .
RESULTS	No differences were noted in the consumption of rescue medication .
CONCLUSIONS	Although both groups differed from placebo , their effect size was small and therefore not likely to be clinically meaningful .

###24683583
OBJECTIVE	This study investigated the role of the bone marrow-derived CD34 + cell in a milieu of osteoprogenitor cells , bone marrow plasma cell adhesion molecules , recombinant human bone morphogenetic protein ( rhBMP ) , and a matrix of crushed cancellous allogeneic bone in the clinical regeneration of functionally useful bone in craniomandibular reconstructions .
OBJECTIVE	The history and current concepts of bone marrow hematopoietic stem cells and mesenchymal stem cells are reviewed as they relate to bone regeneration in large continuity defects of the mandible .
METHODS	Patients with 6 - to 8-cm continuity defects of the mandible with retained proximal and distal segments were randomized into two groups .
METHODS	Group A received an in situ tissue-engineered graft containing 54 38 CD34 + cells/mL along with 54 38 CD44 + , CD90 + , and CD105 + cells/mL together with rhBMP-2 in an absorbable collagen sponge ( 1 mg/cm of defect ) and crushed cancellous allogeneic bone .
METHODS	Group B received the same graft , except the CD34 + cell concentration was 1,012 752 cells/mL .
METHODS	The results were analyzed clinically , radiographic bone density was measured in Hounsfield units ( HU ) , and specimens were analyzed histomorphometrically .
RESULTS	Forty patients participated ( 22 men and 12 women ; mean age , 57 years ) .
RESULTS	Eight of 20 group A patients ( 40 % ) achieved the primary endpoint of mature bone regeneration , whereas all 20 group B patients ( 100 % ) achieved the primary endpoint .
RESULTS	CD34 + cell counts above 200/mL were associated with achievement of the primary endpoint .
RESULTS	Bone density was lower in group A ( 424 115 HU ) than in group B ( 731 98 HU ) .
RESULTS	Group A bone showed a mean trabecular bone area of 36 % 10 % , versus 67 % 13 % for group B.
CONCLUSIONS	The CD34 + cell functions as a central signaling cell to mesenchymal stem cells and osteoprogenitor cells in bone regeneration .
CONCLUSIONS	The mechanism of bone marrow-supported grafts requires a complete milieu to regenerate large quantities of functionally useful bone .
CONCLUSIONS	CD34 + cell counts in a concentration of at least 200/mL in composite grafts are directly correlated to clinically successful bone regeneration .

###25241181
OBJECTIVE	To determine the effect of nutritional supplementation on height , weight , and body mass index ( BMI ) in short and lean prepubertal children .
METHODS	A prospective , randomized , double-blinded , placebo-controlled trial of nutritional supplementation at the endocrinology department of a tertiary pediatric medical center of healthy , lean , short , prepubertal children 3-9-years-old .
METHODS	Anthropometry measurements were measured at 6 months .
RESULTS	Two hundred participants ( 149 boys ) entered the study and 171 ( 85.5 % ) completed the intervention period .
RESULTS	Baseline characteristics including age , sex , height-SDS , weight-SDS , BMI-SDS , and dietary caloric and protein intakes were similar in the formula and placebo groups .
RESULTS	` Good ' consumers ( intake of 50 % of the recommended dose ) in the formula group significantly improved height-SDS ( P < .001 ) and weight-SDS ( P = .005 ) with no change in BMI-SDS compared with ` poor ' consumers and the placebo group .
RESULTS	In the formula-treated group a positive correlation was found between the amount of formula consumed per body weight and the gain in height-SDS ( r = 0.44 , P < .001 ) and weight-SDS ( r = 0.35 , P = .002 ) ; no significant correlations were found in the placebo group .
RESULTS	No serious adverse events were reported during the study .
CONCLUSIONS	Nutritional intervention with the formula was found to be a feasible , effective , and safe approach for promoting the physical growth of short and lean prepubertal children .

###24561771
BACKGROUND	Methylated catechin , one of the active ingredients in green tea , has been reported to ameliorate allergic reactions .
BACKGROUND	We evaluated the efficacy of ` Benifuuki ' green tea , which contains O-methylated epigallocatechin-3-O - [ 3-O-methyl ] gallate ( O-methylated EGCG ) , in alleviating Japanese cedar pollinosis ( JCP ) .
METHODS	The study was a double-blind , randomized , placebo-controlled trial .
METHODS	The subjects with JCP were randomly assigned to drink 700ml of ` Benifuuki ' green tea containing O-methylated EGCG or ` Yabukita ' green tea ( not containing O-methylated EGCG ) as a placebo every day from December 2007 through March 2008 , which includes the pollen season .
METHODS	The primary outcome was the area under the curve ( AUC ) of symptom scores during the peak pollen season .
RESULTS	Fifty-one adults with JCP participated in the study .
RESULTS	Twenty-six subjects were assigned to ` Benifuuki ' and 25 to ` Yabukita ' .
RESULTS	The AUC of symptom score during the peak pollen season in the ` Benifuuki ' group was significantly smaller than in the ` Yabukita ' group for each of runny nose , itchy eyes , tearing , total nasal symptom score , total ocular symptom score , nasal symptom-medication score and ocular symptom-medication score .
RESULTS	The total QOL-related questionnaire score for one week in the peak pollen season was significantly better in the ` Benifuuki ' group .
RESULTS	Increase in the peripheral eosinophil count in response to pollen exposure was suppressed in the ` Benifuuki ' group .
RESULTS	No adverse events were reported in either group .
CONCLUSIONS	` Benifuuki ' green tea containing a large amount of O-methylated EGCG reduced the symptoms of JCP and has potential as a complementary/alternative medicine for treating seasonal allergic rhinitis .

###25137844
OBJECTIVE	To observe the analgesic effect and safety of acupuncture-anesthetic composite anesthesia ( AACA ) in hysteroscopic surgery .
METHODS	Totally 93 patients undergoing hysteroscopic surgery were randomly assigned to the intravenous anesthesia group ( A group , 30 cases ) , the AACA group ( B group , 32 cases ) , and the acupuncture combined with intravenous anesthesia group ( C group , 31 cases ) .
METHODS	Patients in Group A were anesthetized by sufentanil combined propofol .
METHODS	Those in Group B were anesthetized by sufentanil combined acupuncture .
METHODS	Those in Group C were anesthetized by sufentanil , propofol combined acupuncture .
METHODS	Yinlian and Ququan ( LR8 ) were needled for patients in Group B and C.
METHODS	The peri-operative mean arterial pressure ( MAP ) , heart rate ( HR ) , and oxygen saturation ( SpO2 ) , the surgical time , the recovery time , the sufentanil and propofol dosages , adverse anesthesia reactions were observed .
METHODS	Meanwhile , the OAA/S score , Ramsay sedation score , and Visual Analogue Score ( VAS ) were also measured .
RESULTS	Compared with Group A and C , patients in Group B were awake , with obvious increased OAA/S score ( P < 0.01 ) .
RESULTS	Ramsay sedation score was significantly lower ( P < 0.01 ) .
RESULTS	The MAP and HR were elevated ( P < 0.05 ) .
RESULTS	The patient case of SpO2 less than 85 % during the operation decreased ( P < 0.05 ) .
RESULTS	The incidence of postoperative dizziness was reduced ( P < 0.05 ) .
RESULTS	Compared with Group A , the propofol consumption decreased in Group C ( P < 0.05 ) .
RESULTS	There was no statistical difference in the operation time , the sufentanil dosage , VAS score , the incidence of postoperative nause - a and vomiting among the three groups ( P > 0.05 ) .
CONCLUSIONS	The patients were awake in AACA .
CONCLUSIONS	The intraoperative sedation was better than that obtained by intravenous anesthesia .
CONCLUSIONS	But the analgesic effect was similar to that obtained by intravenous anesthesia .

###24257429
BACKGROUND	Early diagnosis of dementia is important because this allows those with dementia and their families to engage support and plan ahead .
BACKGROUND	However , dementia remains underdetected and suboptimally managed in general practice .
BACKGROUND	Our objective was to test the effect of a workplace-based tailored educational intervention developed for general practice on the clinical management of people with dementia .
METHODS	The tailored educational intervention was tested in an unblinded cluster randomized controlled trial with a pre/post-intervention design , with two arms : usual/normal care control versus educational intervention .
METHODS	The primary outcome measure was an increase in the proportion of patients with dementia who received at least two documented dementia-specific management reviews per year .
METHODS	Case identification was a secondary outcome measure .
RESULTS	23 practices in South-East England participated .
RESULTS	A total of 1,072 patients with dementia ( intervention : 512 , control : 560 ) had information in their medical records showing the number of reviews within 12 months ( or a proportion of ) before intervention or randomization and within 12 months ( or a proportion of ) after .
RESULTS	The mean total number of dementia management reviews after the educational intervention for people with dementia was 0.89 ( SD 1.09 ; minimum 0 ; median 1 ; maximum 8 ) compared with 0.89 ( SD 0.92 ; minimum 0 ; median 1 ; maximum 4 ) before intervention .
RESULTS	In the control group prior to randomization the mean total number of dementia management reviews was 1.66 ( SD 1.87 ; minimum 0 ; median 1 ; maximum 12 ) and in the period after randomization it was 1.56 ( SD 1.79 ; minimum 0 ; median 1 ; maximum 11 ) .
RESULTS	Case detection rates were unaffected .
RESULTS	The estimated incidence rate ratio for intervention versus control group was 1.03 ( P = 0.927 , 95 % CI 0.57 to 1.86 ) .
CONCLUSIONS	The trial was timely , coinciding with financial incentives for dementia management in general practice ( through the Quality Outcomes Framework ) ; legal imperatives ( in the form of the Mental Capacity Act 2005 ) ; policy pressure ( The National Dementia Strategy 2009 ) ; and new resources ( such as dementia advisors ) that increased the salience of dementia for general practitioners .
CONCLUSIONS	Despite this the intervention did not alter the documentation of clinical management of patients with dementia in volunteer practices , nor did it increase case identification .
BACKGROUND	NCT00866099/Clinical Trials .

###24407835
OBJECTIVE	The objective of the Japan Strategic Anti-cancer Randomized Trial was to verify the efficacy of the use of ultrasonography in breast cancer screening among women aged 40-49 years .
OBJECTIVE	The purpose of this paper was to report the design and recruitment result of this study .
METHODS	In this study of women in their 40s , the participants were divided into two groups , one of which ( the intervention group ) was subjected to mammography and ultrasonography ( using a standardized ultrasonography examination ) , while the other ( the control group ) was examined with mammography , in a randomized controlled trial , with the objective of verifying the accuracy and efficacy of examinations by comparing the two groups .
RESULTS	The cumulative total number of participants registered in the study was 76 196 ( 38 313 in the intervention group and 37 883 in the control group ) .
RESULTS	71.0 % of participants registered to the study were under individual randomized controlled trial , 25.0 % were under cluster randomized controlled trial and 3.9 % were under non-randomized controlled group .
RESULTS	The study was designed so that participants registered at their first examination underwent examinations by the same method for the subsequent two years .
RESULTS	74.1 % of participants scheduled for a second examination had undertaken it , while information regarding the presence of interval cancer had been obtained from a further 20.6 % using a questionnaire .
RESULTS	At July 2013 , the status of 5.3 % of all participants was unclear .
CONCLUSIONS	It was the first large-scale randomized controlled trial carried out in Japan .
CONCLUSIONS	The scheduled second examinations were completed at the end of fiscal 2012 .
CONCLUSIONS	Once the proportion of participants whose status is unclear has fallen to 5 % , the authors plan to collate the data relating to the primary end points , and publish the results .

###24899360
BACKGROUND	Oral iron supplementation is often associated with rapid onset of gastrointestinal side-effects .
BACKGROUND	The aim of this study was to develop and trial a short , simple questionnaire to capture these early side-effects and to determine which symptoms are more discriminating .
METHODS	The study was a double-blind placebo-controlled randomized parallel trial with one week treatment followed by one week wash-out .
METHODS	Subjects were randomized into two treatment groups ( n = 10/group ) to receive either ferrous sulphate ( 200mg capsules containing 65mg of iron ) or placebo , both to be taken at mealtimes twice daily during the treatment period .
METHODS	Subjects completed the questionnaires daily for 14days .
METHODS	The questionnaire included gastrointestinal symptoms commonly reported to be associated with the oral intake of ferrous iron salts ( i.e. nausea , vomiting , heartburn , abdominal pain , diarrhoea , and constipation ) .
RESULTS	Seventy five per cent of participants reporting the presence of one or more symptoms in the first week of the study were in the ferrous sulphate group .
RESULTS	In the second week of the study ( i.e. wash-out ) , 67 % of the participants reporting one or more symptom ( s ) were in the ferrous sulphate group .
RESULTS	In the first week of the study ( treatment ) the number of symptoms reported by participants in the ferrous sulphate group ( meanSEM = 6.71.7 ) was significantly higher than that for participants in the placebo group ( 1.20.5 ) ( p = 0.01 ) .
RESULTS	In the second week of the study ( wash-out ) the number of symptoms reported by participants in the ferrous sulphate group ( 4.62.0 ) appeared higher than for participants in the placebo group ( 1.00.7 ) although this did not reach significance ( p = 0.12 ) .
RESULTS	Events for which the gastrointestinal symptom questionnaire was most discriminatory between ferrous sulphate and placebo groups were : heartburn , abdominal pain and the presence of black stools ( all p0 .03 ) .
CONCLUSIONS	A tool for the detection of commonly-occurring side effects should not require large study numbers to be effective .
CONCLUSIONS	With just 10 subjects per group ( iron or placebo ) , this simple questionnaire measures gastrointestinal side-effects associated with oral iron ( ferrous sulphate ) supplementation , and would be appropriate for use in intervention studies or clinical trials .
BACKGROUND	ClinicalTrials.gov Identifier : NCT02146053 ( 21/05/2014 ) .

###25056431
BACKGROUND	E-health initiatives hold promise to improve shared-care models of health care .
BACKGROUND	In 2008-2011 we developed and trialled web-based software to facilitate a randomised trial of a shared-care approach for childhood obesity involving General Practitioners ( GPs ) working with tertiary specialists .
BACKGROUND	We describe the software 's development , implementation and evaluation , and make recommendations for future e-health initiatives .
BACKGROUND	The web-based software was designed with the goals of allowing both GPs and specialists to communicate and review patient progress ; integrating with existing GP software ; and supporting GPs to deliver the structured intervention .
BACKGROUND	Specifically , we aimed to highlight the challenges inherent in this process , and report on the extent to which the software ultimately met its implementation and user aims .
METHODS	The study was conducted at the Royal Children 's Hospital and 22 general practices across Melbourne , Australia .
METHODS	Participants comprised 30 GPs delivering the shared-care intervention .
METHODS	Outcomes included the following .
METHODS	( 1 ) GPs ' pre-specified software requirements : transcribed from two focus groups and analysed for themes using content analysis .
METHODS	( 2 ) Software implementation and performance based on the experience of the research team and GPs .
METHODS	( 3 ) GP users ' evaluation collected via questionnaire .
METHODS	( 4 ) Software usage collected via GP questionnaire and qualified through visual inspection of the software meta-data .
RESULTS	Software implementation posed difficult and at times disabling technological barriers ( e.g. out-dated hardware , poor internet connections ) .
RESULTS	The software 's speed and inability to seamlessly link with day-to-day software was a source of considerable frustration .
RESULTS	Overall , GPs rated software usability as poor , although most ( 68 % ) felt that the structure and functionality of the software was useful .
RESULTS	Recommendations for future e-health initiatives include thorough scoping of IT systems and server speed , testing across diverse environments , automated pre-requisite checks and upgrades of processors/memory where necessary , and user-created usernames and passwords .
CONCLUSIONS	GPs are willing to embrace novel technologies to support their practice .
CONCLUSIONS	However , implementation remains challenging mainly for technical reasons , and this precludes further evaluation of potential user-specific barriers .
CONCLUSIONS	These findings could inform future e-health ventures into shared-care , and highlight the need for an appropriate infrastructure .
BACKGROUND	Australian New Zealand Clinical Trials Registry : ACTRN126080000553 .

###25651491
OBJECTIVE	The aim of this study was to assess the efficacy of using a combination treatment approach consisting of lipid emulsion eye drops , eyelid cleansing wipes , and omega-3 vitamin supplements compared with warm compresses in improving meibomian gland functionality in patients with lipid-deficient/evaporative dry eye disease ( LDDE ) .
METHODS	This single-center , open-label , investigator-masked , randomized study enrolled patients aged 18 years , clinically diagnosed with LDDE defined as having 6 functional meibomian glands [ meibomian gland yielding liquid secretion ( MGYLS ) ] and positive for dry eye symptoms at screening .
METHODS	Patients were randomized to receive either the combination treatment ( lipid emulsion eye drops , omega-3 supplements , and lid hygiene with eyelid wipes ) or to apply warm , wet compresses once daily , 8 minutes per day , for 3 months .
METHODS	Meibomian gland functionality ( number of MGYLS ; primary outcome ) and patient-reported subjective assessments ( SPEED and OSDI questionnaires ; secondary outcomes ) were evaluated .
METHODS	Adverse events ( AEs ) and visual acuity were assessed as safety endpoints .
RESULTS	Mean patient age was 41.7 years ( n = 26 ; n = 13 per group ) .
RESULTS	Mean SD number of MGYLS was not statistically significantly different between groups at baseline ( combination treatment , 3.5 1.5 ; warm compresses , 4.2 1.4 , P > 0.5 ) , and was significantly greater with combination treatment versus warm compresses after 3 months of treatment ( 9.3 2.7 vs. 4.7 2.3 ; P = 0.006 ) .
RESULTS	Dry eye symptoms were significantly improved in both groups at all follow-up visits .
RESULTS	Two AEs unrelated to treatment were reported ; the BCVA was unchanged from baseline in both groups .
CONCLUSIONS	The combination treatment regimen resulted in significant improvement in meibomian gland functionality and dry eye symptoms .
CONCLUSIONS	No safety issues were observed .

###24635110
BACKGROUND	Radiotherapy-induced trismus ( RTIT ) is a debilitating condition without any proven effective treatment .
BACKGROUND	This study investigates the effectiveness of prophylactic training to prevent RTIT during and up to 12 months after completed RT in patients with head and neck cancer ( HNC ) , also investigating the incidence of RTIT .
METHODS	Sixty-six consecutive patients from two RT clinics in Sweden were randomised into one of two groups : training with TheraBite ( ) Jaw Motion Rehabilitation System ( ) or a control group .
METHODS	Maximum interincisal openings ( MIO ) were recorded at baseline and once a week during treatment , three , six and 12 months after completed RT. .
METHODS	Training frequency was recorded by patients in a log book .
RESULTS	There were no significant differences in MIO between the intervention and control groups at any of the measurement points .
RESULTS	Patients in both groups maintained their normal variation in MIO at 12 months after completed RT. .
RESULTS	A small group of patients in the control group had a 17 % mean decrease in MIO by week 6 compared to baseline and improved their MIO by using the training programme .
RESULTS	There was a significant mean difference in MIO from baseline to week 6 ( 3 mm , p = 0.018 ) , and month 6 ( 2.7 mm , p = 0.040 ) , for patients receiving 3D conformal radiotherapy .
RESULTS	There was a significant difference in MIO between patients treated with RT and concurrent chemotherapy compared to patients with RT only at 12 months ( p = 0.033 ) .
CONCLUSIONS	Patients with HNC undergoing high dose RT do not need to be burdened with an intense prophylactic training programme during RT and up to 12 months after completed RT. .
CONCLUSIONS	MIO measurements during RT and up to 12 months after completed RT are recommended to identify a small risk group who are an exception and may need a training programme .

###26039949
OBJECTIVE	This study investigated the acute hemodynamic responses to multiple sets of passive stretching exercises performed with and without the Valsalva maneuver .
METHODS	Fifteen healthy men aged 21 to 29 years with poor flexibility performed stretching protocols comprising 10 sets of maximal passive unilateral hip flexion , sustained for 30 seconds with equal intervals between sets .
METHODS	Protocols without and with the Valsalva maneuver were applied in a random counterbalanced order , separated by 48-hour intervals .
METHODS	Hemodynamic responses were measured by photoplethysmography pre-exercise , during the stretching sets , and post-exercise .
RESULTS	The effects of stretching sets on systolic and diastolic blood pressure were cumulative until the fourth set in protocols performed with and without the Valsalva maneuver .
RESULTS	The heart rate and rate pressure product increased in both protocols , but no additive effect was observed due to the number of sets .
RESULTS	Hemodynamic responses were always higher when stretching was performed with the Valsalva maneuver , causing an additional elevation in the rate pressure product .
CONCLUSIONS	Multiple sets of unilateral hip flexion stretching significantly increased blood pressure , heart rate , and rate pressure product values .
CONCLUSIONS	A cumulative effect of the number of sets occurred only for systolic and diastolic blood pressure , at least in the initial sets of the stretching protocols .
CONCLUSIONS	The performance of the Valsalva maneuver intensified all hemodynamic responses , which resulted in significant increases in cardiac work during stretching exercises .

###24415665
OBJECTIVE	To assess whether granulocyte colony-stimulating factor ( G-CSF ) treatment induces a sustained benefit on adverse remodelling in patients with large anterior ST-elevation myocardial infarction ( STEMI ) and left ventricular ( LV ) dysfunction after successful reperfusion .
METHODS	The STEM-AMI Trial was a prospective , placebo-controlled , multicentre study .
METHODS	Sixty consecutive patients with a first anterior STEMI , who underwent primary percutaneous coronary intervention 2-12 h after symptom onset , with LV ejection fraction ( LVEF ) 45 % measured by echocardiography within 12 h after successful revascularisation ( TIMI flow score 2 ) , were randomised 1:1 to G-CSF ( 5 g/Kg body weight b.i.d. ) or placebo .
METHODS	Clinical events and Major Adverse Cardiac and Cerebrovascular Event ( MACCE ) were monitored , and LVEF , LV end-diastolic ( LVEDV ) and end-systolic ( LVESV ) volumes , and infarct size were evaluated by MRI at the final 3-year follow-up .
RESULTS	Fifty-four patients completed the study , of whom 35 with MRI .
RESULTS	No significant differences were found in mortality and MACCE between G-CSF and placebo-treated groups .
RESULTS	The 3-year infarct size was not different between groups , whereas LVEDV was significantly lower in G-CSF ( n = 20 ) than in placebo ( n = 15 ) patients ( 170.18.1 vs 197.28.9 mL , respectively ; p = 0.033 at analysis of covariance ) .
RESULTS	A significant inverse correlation was detected in G-CSF patients between the number of circulating CD34 cells at 30 days after reperfusion and the 3-year absolute and indexed LVEDV ( = -0.71 , 95 % CI -0.90 to -0.30 , and = -0.62 , -0.86 to -0.14 , respectively ) , or their change over time ( r = -0.59 , -0.85 to -0.11 , and r = -0.55 , -0.83 to -0.06 , respectively ) .
CONCLUSIONS	G-CSF therapy may be beneficial in attenuating ventricular remodelling subsequent to a large anterior STEMI in the long term .
CONCLUSIONS	No differences have been detected in clinical outcome .

###24588434
OBJECTIVE	To identify risk factors for development of hypophosphataemia in patients treated with two different intensities of continuous renal replacement therapy ( CRRT ) and to assess the independent association of hypophosphataemia with major clinical outcomes .
METHODS	We performed secondary analysis of data collected from 1441 patients during a large , multicentre randomised controlled trial of CRRT intensity .
METHODS	We allocated patients to two different intensities of CRRT ( 25mL/kg/hour vs 40 mL/kg/hour of effluent generation ) and obtained daily measurement of serum phosphate levels .
RESULTS	We obtained 14 115 phosphate measurements and identified 462 patients ( 32.1 % ) with hypophosphataemia , with peak incidence on Day 2 and Day 3 .
RESULTS	With lower intensity CRRT , there were 58 episodes of hypophosphataemia/1000 patient days , compared with 112 episodes/1000 patient days with higher intensity CRRT ( P < 0.001 ) .
RESULTS	On multivariable logistic regression analysis , higher intensity CRRT , female sex , higher Acute Physiology and Chronic Health Evaluation score and hypokalaemia were independently associated with an increased odds ratio ( OR ) for hypophosphataemia .
RESULTS	On multivariable models , hypophosphataemia was associated with better clinical outcomes , but when analysis was confined to patients alive at 96 hours , hypophosphataemia was not independently associated with clinical outcomes .
CONCLUSIONS	Hypophosphataemia is common during CRRT and its incidence increases with greater CRRT intensity .
CONCLUSIONS	Hypophosphataemia is not a robust independent predictor of mortality .
CONCLUSIONS	Its greater incidence in the higher intensity CRRT arm of the Randomised Evaluation of Normal vs Augmented Level trial does not explain the lack of improved outcomes with such treatment .

###24965754
BACKGROUND	Irritable bowel syndrome ( IBS ) is among the most common gastrointestinal disorders worldwide .
BACKGROUND	In selected patients with severe diarrhoea-predominant or mixed IBS subtypes sacral nerve stimulation ( SNS ) alleviates IBS-specific symptoms and improves quality of life .
BACKGROUND	The mode of action , however , remains unknown .
BACKGROUND	The present study aimed to evaluate the effect of SNS on small intestinal motility in IBS patients .
METHODS	Twenty patients treated with SNS for severe diarrhoea-predominant or mixed IBS were included in a randomised , controlled , crossover study .
METHODS	The neurostimulator was turned ON or OFF for the first one month and then to the opposite setting for the next month .
METHODS	Gastrointestinal transit patterns were investigated with the Motility Tracking System-1 ( MTS-1 ) at the end of each the ON and OFF period .
METHODS	Primary endpoint was change in the velocity of the magnetic pill within the small intestine .
METHODS	Statistical testing was performed with Wilcoxon 's rank sum test and Fisher 's exact test .
RESULTS	The median velocity of the magnetic pill through the small intestine in the fasting state was not significantly different between periods with and without SNS ( Group ON-OFF : median change 0 m/h ( range -1.07 , 0.63 ) , Group OFF-ON : median change 0.27 m/h ( range -0.59 , 1.12 ) ) ( p = 0.25 ) .
RESULTS	Neither , was the median velocity of the magnetic pill through the small intestine in the postprandial state significantly different between periods with and without SNS ( Group ON-OFF : median change -0.13 m/h ( range -0.46 , 0.23 ) , Group OFF-ON : median change 0.015 m/h ( range -0.48 , 0.59 ) ) ( p = 0.14 ) .
CONCLUSIONS	Even though SNS may reduce symptoms of diarrhoea-predominant and mixed IBS , it has no detectable effect on small intestinal transit patterns .
BACKGROUND	Clinical.trials.gov , ( NCT00919672 ) .

###24713309
BACKGROUND	Fetal survival is severely compromised when the amniotic membrane ruptures between 16 and 24 weeks of pregnancy .
BACKGROUND	Reduced amniotic fluid levels are associated with poor lung development , whereas adequate levels lead to better perinatal outcomes .
BACKGROUND	Restoring amniotic fluid by means of ultrasound-guided amnioinfusion ( AI ) may be of benefit in improving perinatal and long-term outcomes in children of pregnancies with this condition .
OBJECTIVE	The AI in preterm premature rupture of membranes ( AMIPROM ) pilot study was conducted to assess the feasibility of recruitment , the methods for conduct and the retention through to long-term follow-up of participants with very early rupture of amniotic membranes ( between 16 and 24 weeks of pregnancy ) .
OBJECTIVE	It was also performed to assess outcomes and collect data to inform a larger , more definitive , clinical trial .
METHODS	A prospective , non-blinded randomised controlled trial .
METHODS	A computer-generated random sequence using a 1 : 1 ratio was used .
METHODS	Randomisation was stratified for pregnancies in which the amniotic membrane ruptured between 16 ( +0 ) and 19 ( +6 ) weeks ' gestation and 20 ( +0 ) and 24 ( +0 ) weeks ' gestation .
METHODS	The randomisation sequence was generated in blocks of four .
METHODS	Telephone randomisation and intention-to-treat analysis were used .
METHODS	Four UK hospital-based fetal medicine units - Liverpool Women 's NHS Trust , St. Mary 's Hospital , Manchester , Birmingham Women 's NHS Foundation Trust and Wirral University Hospitals Trust .
METHODS	Women with confirmed preterm prelabour rupture of membranes between 16 ( +0 ) and 24 ( +0 ) weeks ' gestation .
METHODS	Women with multiple pregnancies , resultant fetal abnormalities or obstetric indication for immediate delivery were excluded .
METHODS	Participants were randomly allocated to either serial weekly transabdominal AI or expectant management ( Exp ) until 37 weeks of pregnancy , if the deepest pool of amniotic fluid was < 2 cm .
METHODS	Short-term maternal , pregnancy and neonatal outcomes and long-term outcomes for the child were studied .
METHODS	Long-term respiratory morbidity was assessed using validated respiratory questionnaires at 6 , 12 and 18 months of age and infant lung function was assessed at approximately 12 months of age .
METHODS	Neurodevelopment was assessed using Bayley 's Scale of Infant Development II at a corrected age of 2 years .
RESULTS	Fifty-eight women were randomised and two were excluded from the analysis owing to termination of pregnancy for lethal anomaly , leaving 56 participants ( 28 serial AI , 28 Exp ) recruited between 2002 and 2009 , with annual recruitment rates varying between 2 and 14 .
RESULTS	Recruitment to the study improved significantly from 2007 with National Institute for Health Research ( NIHR ) funding .
RESULTS	There was no significant difference in perinatal mortality [ 19/28 vs. 19/28 ; relative risk ( RR ) 1.0 ; 95 % confidence interval ( CI ) 0.70 to 1.43 ] , maternal morbidity or neonatal morbidity .
RESULTS	The overall chance of surviving without long-term respiratory or neurodevelopmental disability is 4/56 ( 7.1 % ) : 4/28 ( 14.3 % ) in the AI arm and 0/28 in the expectant arm ( 0 % ) ( RR 9.0 ; 95 % CI 0.51 to 159.70 ) .
CONCLUSIONS	This pilot study found no major differences in maternal , perinatal or pregnancy outcomes .
CONCLUSIONS	The study was not designed to show a difference between the arms and the number of survivors was too small to draw any conclusions about long-term outcomes .
CONCLUSIONS	It does signal , however , that a larger , definitive , study to evaluate AI for improvement in healthy survival is indicated .
CONCLUSIONS	The results suggest that , with appropriate funding , such a study is feasible .
CONCLUSIONS	A larger , definitive , study with full health economic analysis and patient perspective assessment is required to show whether AI can improve the healthy survivor rate .

###24469621
BACKGROUND	Emergency endovascular repair ( EVAR ) for ruptured abdominal aortic aneurysm ( rAAA ) may have lower operative mortality rates than open surgical repair .
BACKGROUND	Concerns remain that the early survival benefit after EVAR for rAAA may be offset by late reinterventions .
BACKGROUND	The aim of this study was to compare reintervention rates and cost-effectiveness of EVAR and open repair for rAAA .
METHODS	A retrospective analysis was undertaken of patients with rAAA undergoing EVAR or open repair over 6years .
METHODS	A health economic model developed for the cost-effectiveness of elective EVAR was used in the emergency setting .
RESULTS	Sixty-two patients ( mean age 779years ) underwent EVAR and 85 ( mean age 759years ) had open repair of rAAA .
RESULTS	Median follow-up was 42 and 39months respectively .
RESULTS	There was no significant difference in 30-day mortality rates after EVAR and open repair ( 18 and 26 per cent respectively ; P = 0243 ) .
RESULTS	Reintervention rates were also similar ( 32 and 31 per cent ; P = 0701 ) .
RESULTS	The mean cost per patient was 26,725 for EVAR and 30,297 for open repair , and the cost per life-year gained was 7906 and 9933 respectively ( P = 0561 ) .
RESULTS	Open repair had greater initial costs : longer procedural times ( 217 versus 1785min ; P < 0001 ) and intensive care stay ( 50 versus 10days ; P = 0015 ) .
RESULTS	Conversely , EVAR had greater reintervention ( 156,939 versus 35,335 ; P = 0001 ) and surveillance ( P < 0001 ) costs .
CONCLUSIONS	There was no significant difference in reintervention rates after EVAR or open repair for rAAA .
CONCLUSIONS	EVAR was as cost-effective at mid-term follow-up .
CONCLUSIONS	The increased procedural costs of open repair are not outweighed by greater surveillance and reintervention costs after EVAR .

###24500556
OBJECTIVE	To compare the effects of real-time continuous glucose monitoring ( RT-CGM ) and an Internet blood glucose monitoring system ( IBGMS ) on glycated hemoglobin levels in patients with type 2 diabetes mellitus treated with insulin .
METHODS	Fifty-seven patients with type 2 diabetes treated with insulin were assigned randomly to 1 of 2 groups .
METHODS	Group 1 had the results of their self-monitoring of blood glucose level monitored biweekly using an IBGMS .
METHODS	Group 2 used RT-CGM and were monitored biweekly .
METHODS	Both groups used a secure website to upload data and to receive feedback from their endocrinologist .
METHODS	A1C and laboratory test results were collected at 0 , 3 and 6 months .
RESULTS	The baseline parameters were not significantly different .
RESULTS	After a 6-month follow-up period , both IBGMS and RT-CGM showed significant within-group improvements in A1C level .
RESULTS	In the IBGMS group , the A1C level decreased from 8.79 % 1.25 % to 7.96 % 1.30 % ( p < 0.05 ) .
RESULTS	The RT-CGM group decreased from 8.80 % 1.37 % to 7.49 % 0.70 % ( p < 0.001 ) .
RESULTS	IBGMS and RT-CGM did not show significantly different A1C levels at baseline , 3 and 6 months ( p > 0.05 ) .
CONCLUSIONS	The use of both IBGMS and RT-CGM significantly improved A1C levels in patients with type 2 diabetes treated with insulin in a randomized trial over a 6-month period .
CONCLUSIONS	There were no significant differences in A1C values between groups after 6 months .

###24870115
OBJECTIVE	The aim of this study was to investigate the effects of a noninvasive positive pressure ventilation therapy on cardiac structure and function in patients with coronary heart disease combined with obstructive sleep apnea/hypopnea syndrome ( OSAHS ) .
METHODS	Eighty patients with coronary heart disease OSAHS were divided randomly into treatment ( n = 40 ) and control ( n = 40 ) groups .
METHODS	Both groups received standard medications .
METHODS	The treatment group received additional noninvasive mechanical ventilation support for at least 3 h ( 3-6 h ) every night .
METHODS	On the first day after selection and 3 months afterwards , participants were examined with echocardiograms , 24-h ambulatory blood pressure monitoring , and blood analyses .
METHODS	Primary endpoints were left ventricular end-diastolic diameter , left ventricular end-systolic diameter , left ventricular ejection fraction , left atrial diameter as well as serum concentrations of N-terminal prohormone of brain natriuretic peptide , and high-sensitive C-reactive protein .
METHODS	Secondary endpoints included cardiac death , nonfatal myocardial infarction , and hospitalization .
RESULTS	After the 3-month study period , patients in the treatment group showed significantly improved left ventricular end-diastolic diameter ( P = 0.02 ) , left ventricular end-systolic diameter ( P = 0.035 ) , left ventricular ejection fraction ( P = 0.05 ) , and left atrial diameter ( P = 0.02 ) values , and their serum N-terminal prohormone of brain natriuretic peptide ( P = 0.01 ) and high-sensitive C-reactive protein ( P = 0.04 ) concentrations were significantly improved compared with the control group .
RESULTS	During the 3 months , three cardiovascular complications occurred in the treatment group versus nine in the control group ( P < 0.05 ) .
CONCLUSIONS	For patients with coronary heart disease combined with OSAHS , noninvasive mechanical ventilation therapy can significantly improve heart functions and reduce the occurrence of cardiovascular complications .

###25415413
BACKGROUND	After an intense bout of exercise , foam rolling is thought to alleviate muscle fatigue and soreness ( ie , delayed-onset muscle soreness [ DOMS ] ) and improve muscular performance .
BACKGROUND	Potentially , foam rolling may be an effective therapeutic modality to reduce DOMS while enhancing the recovery of muscular performance .
OBJECTIVE	To examine the effects of foam rolling as a recovery tool after an intense exercise protocol through assessment of pressure-pain threshold , sprint time , change-of-direction speed , power , and dynamic strength-endurance .
METHODS	Controlled laboratory study .
METHODS	University laboratory .
METHODS	A total of 8 healthy , physically active males ( age = 22.1 2.5 years , height = 177.0 7.5 cm , mass = 88.4 11.4 kg ) participated .
METHODS	Participants performed 2 conditions , separated by 4 weeks , involving 10 sets of 10 repetitions of back squats at 60 % of their 1-repetition maximum , followed by either no foam rolling or 20 minutes of foam rolling immediately , 24 , and 48 hours postexercise .
METHODS	Pressure-pain threshold , sprint speed ( 30-m sprint time ) , power ( broad-jump distance ) , change-of-direction speed ( T-test ) , and dynamic strength-endurance .
RESULTS	Foam rolling substantially improved quadriceps muscle tenderness by a moderate to large amount in the days after fatigue ( Cohen d range , 0.59 to 0.84 ) .
RESULTS	Substantial effects ranged from small to large in sprint time ( Cohen d range , 0.68 to 0.77 ) , power ( Cohen d range , 0.48 to 0.87 ) , and dynamic strength-endurance ( Cohen d = 0.54 ) .
CONCLUSIONS	Foam rolling effectively reduced DOMS and associated decrements in most dynamic performance measures .

###24384803
OBJECTIVE	Evaluate a computerized intervention supporting antiretroviral therapy ( ART ) adherence and HIV transmission prevention .
METHODS	Longitudinal randomized controlled trial .
METHODS	An academic HIV clinic and a community-based organization in Seattle .
METHODS	In a total of 240 HIV-positive adults on ART , 209 completed 9-month follow-up ( 87 % retention ) .
METHODS	Randomization to computerized counseling or assessment only , 4 sessions over 9 months .
METHODS	HIV-1 viral suppression , and self-reported ART adherence and transmission risks , compared using generalized estimating equations .
RESULTS	Overall , intervention participants had reduced viral load : mean 0.17 log10 decline , versus 0.13 increase in controls , P = 0.053 , and significant difference in ART adherence baseline to 9 months ( P = 0.046 ) .
RESULTS	Their sexual transmission risk behaviors decreased ( odds ratio = 0.55 , P = 0.020 ) , a reduction not seen among controls ( odds ratio = 1.1 , P = 0.664 ) , and a significant difference in change ( P = 0.040 ) .
RESULTS	Intervention effect was driven by those most in need ; among those with detectable virus at baseline ( > 30 copies/mL , n = 89 ) , intervention effect was mean 0.60 log10 viral load decline versus 0.15 increase in controls , P = 0.034 .
RESULTS	ART adherence at the final follow-up was 13 points higher among intervention participants versus controls , P = 0.038 .
CONCLUSIONS	Computerized counseling is promising for integrated ART adherence and safer sex , especially for individuals with problems in these areas .
CONCLUSIONS	This is the first intervention to report improved ART adherence , viral suppression , and reduced secondary sexual transmission risk behavior .

###26182760
BACKGROUND	Ureteric stones greater than 6mm require intervention .
BACKGROUND	Extracorporeal shockwave lithotripsy ( ESWL ) and ureteroscopy ( URS ) with intra-corporeal lithotripsy ( ICL ) are two least invasive therapies .
BACKGROUND	Both show acceptable stone clearance .
BACKGROUND	What should be the first line of treatment in distal ureteric stones ?
BACKGROUND	We conducted this study to compare the efficacy-of ESWL and pneumatic ICL in order to develop clear cut treatment guidelines .
METHODS	This randomized control trial was conducted at Institute of Kidney Diseases , Peshawar from June 2011 to June 2012 .
METHODS	Two hundred and twenty-four patients with distal ureteric stones 6-12 mm in size were included .
METHODS	Patients were randomized into two groups .
METHODS	Group-A patients were treated with URS plus ICL and Group-B with ESWL .
METHODS	Patients were evaluated for stone clearance after 2 weeks , with X-ray KUB and ultrasound .
METHODS	All the data were recorded in a pro forma and analysed in SPSS 10 .
METHODS	Fisher 's exact test was applied to compare the efficacy and a p-value of 0.05 was considered significant .
RESULTS	Out of 112 patients in Group-A , 75 ( 67 % ) were males and 37 ( 33 % ) were females while in Group-B 79 ( 70.5 % ) were males and 33 ( 29.5 % ) were females .
RESULTS	The mean age in Group-A was , 48.73 + / - 16.23 years whereas it was 46 + / - 14.58 years in Group-B .
RESULTS	Overall , mean age was 47.36 + / -15.4 years .
RESULTS	Mean stone size was 9.18 + / - 1.6 mm .
RESULTS	At follow up ( 2 weeks post-operative ) URS with ICL was successful in 101 ( 90.2 % ) patients while ESWL was successful in 75 ( 67 % ) patients ( p-value = 0.0001 ) .
CONCLUSIONS	Extracorporeal shockwave lithotripsy shows acceptable stone clearance but ureteroscopy with intra-corporeal lithotripsy shows superior results in distal ureteric stones .

###24894652
BACKGROUND	Preclinical and early clinical data support the use of Vascular Epithelial Growth Factor ( VEGF ) - targeted therapy with trastuzumab in Human Epidermal Receptor 2 ( HER2 ) positive breast cancer .
BACKGROUND	Adding bevacizumab to a taxane ( docetaxel or paclitaxel ) improves progression free survival ( PFS ) of metastatic breast cancer ( MBC ) patients .
OBJECTIVE	We evaluated the efficacy and feasibility of combining bevacizumab with trastuzumab and docetaxel in patients with HER2 - positive MBC who received 0-1 prior chemotherapy regimens for metastatic disease .
OBJECTIVE	The primary end point was PFS .
METHODS	Eligible patients received bevacizumab ( 15 mg/kg ) , trastuzumab ( 8 mg/kg loading dose followed by 6 mg/kg ) , and docetaxel ( 100 mg/m2 initially , later amended to 75 mg/m2 ) every three weeks for six cycles and then were allowed to receive bevacizumab and trastuzumab alone .
METHODS	Results Thirteen ( 50 % ) of 26 patients enrolled completed all 6 cycles of bevacizumab , trastuzumab and docetaxel and went on to receive bevacizumab and trastuzumab alone ( median : 11 cycles ) .
METHODS	The most common grade 3 or 4 toxicities include : neutropenia ( 8 % ) , septic death ( 4 % ) , infection not associated with neutropenia ( 15 % ) , fatigue ( 27 % ) , mylagia and/or arthraligia ( 20 % ) , and hand-foot syndrome ( 8 % ) .
METHODS	One patient ( 4 % ) and six patients ( 23 % ) developed grade 3 and grade 2 hypertension , respectively .
METHODS	Two ( 8 % ) patients had transient grade 2 drop in Left Ventricular Ejection Fraction ( LVEF ) with full recovery later .
METHODS	The median progression free survival ( PFS ) was 14.3 months ( 95 % CI : 9.3-35 months ) , the objective response rate ( ORR ) , defined as the best response of complete response ( CR ) or partial response ( PR ) was ( 12/26 ) 46 % .
METHODS	The clinical benefit rate ( CBR ) , defined as the best response of CR or PR or stable disease ( SD ) for at least 24 weeks , was ( 18/26 ) 69 % ( 95 % CI : 48-86 % ) .
CONCLUSIONS	The combination of bevacizumab , trastuzumab and docetaxel is well tolerated and is clinically active in patients with HER2-positive MBC , with response rate and PFS comparable to previous reports utilizing higher dose of docetaxel ( 100 mg/m2 ) .
CONCLUSIONS	Recent randomized trials did not demonstrate additional overall survival ( OS ) benefit of adding bevacizumab to trastuzumab and docetaxel despite an improvement in PFS .
CONCLUSIONS	Identification of predictive biomarkers and careful patient selection should be incorporated in further investigation of anti-VEGF in breast cancer .

###24398888
BACKGROUND	The purpose of this study was to determine among maintenance hemodialysis patients with echocardiographic left ventricular hypertrophy and hypertension whether in comparison with a - blocker-based antihypertensive therapy , an angiotensin converting enzyme-inhibitor-based antihypertensive therapy causes a greater regression of left ventricular hypertrophy .
METHODS	Subjects were randomly assigned to either open-label lisinopril ( n = 100 ) or atenolol ( n = 100 ) each administered three times per week after dialysis .
METHODS	Monthly monitored home blood pressure ( BP ) was controlled to < 140/90 mmHg with medications , dry weight adjustment and sodium restriction .
METHODS	The primary outcome was the change in left ventricular mass index ( LVMI ) from baseline to 12 months .
RESULTS	At baseline , 44-h ambulatory BP was similar in the atenolol ( 151.5 / 87.1 mmHg ) and lisinopril groups , and improved similarly over time in both groups .
RESULTS	However , monthly measured home BP was consistently higher in the lisinopril group despite the need for both a greater number of antihypertensive agents and a greater reduction in dry weight .
RESULTS	An independent data safety monitoring board recommended termination because of cardiovascular safety .
RESULTS	Serious cardiovascular events in the atenolol group occurred in 16 subjects , who had 20 events , and in the lisinopril group in 28 subjects , who had 43 events { incidence rate ratio ( IRR ) 2.36 [ 95 % confidence interval ( 95 % CI ) 1.36-4 .23 , P = 0.001 ] } .
RESULTS	Combined serious adverse events of myocardial infarction , stroke and hospitalization for heart failure or cardiovascular death in the atenolol group occurred in 10 subjects , who had 11 events and in the lisinopril group in 17 subjects , who had 23 events ( IRR 2.29 , P = 0.021 ) .
RESULTS	Hospitalizations for heart failure were worse in the lisinopril group ( IRR 3.13 , P = 0.021 ) .
RESULTS	All-cause hospitalizations were higher in the lisinopril group [ IRR 1.61 ( 95 % CI 1.18-2 .19 , P = 0.002 ) ] .
RESULTS	LVMI improved with time ; no difference between drugs was noted .
CONCLUSIONS	Among maintenance dialysis patients with hypertension and left ventricular hypertrophy , atenolol-based antihypertensive therapy may be superior to lisinopril-based therapy in preventing cardiovascular morbidity and all-cause hospitalizations .
CONCLUSIONS	( Funded by the National Institute of Diabetes and Digestive and Kidney Diseases ; ClinicalTrials.gov number : NCT00582114 ) .

###25322311
OBJECTIVE	We tested a modified Network for the Improvement of Addiction Treatment ( NIATx ) process improvement model to implement improved HIV services ( prevention , testing , and linkage to treatment ) for offenders under correctional supervision .
METHODS	As part of the Criminal Justice Drug Abuse Treatment Studies , Phase 2 , the HIV Services and Treatment Implementation in Corrections study conducted 14 cluster-randomized trials in 2011 to 2013 at 9 US sites , where one correctional facility received training in HIV services and coaching in a modified NIATx model and the other received only HIV training .
METHODS	The outcome measure was the odds of successful delivery of an HIV service .
RESULTS	The results were significant at the .05 level , and the point estimate for the odds ratio was 2.14 .
RESULTS	Although overall the results were heterogeneous , the experiments that focused on implementing HIV prevention interventions had a 95 % confidence interval that exceeded the no-difference point .
CONCLUSIONS	Our results demonstrate that a modified NIATx process improvement model can effectively implement improved rates of delivery of some types of HIV services in correctional environments .

###25249429
OBJECTIVE	Based on experimental results , various authors have advocated a size 4 ProSeal laryngeal mask airway ( PLMA ) in preference to a size 3 PLMA for women given a neuromuscular blocking agent because the larger size provided a better airway seal .
OBJECTIVE	However , spontaneously breathing patients may be ventilated adequately with a lower seal pressure than that needed for mechanical ventilation .
OBJECTIVE	Therefore , a smaller size might be preferable as its reduced bulk possibly induces less mucosal damage in non-paralyzed patients .
METHODS	A total of 152 females undergoing general anesthesia for short outpatient gynecological surgeries were randomly allocated in equal numbers to insertion of a size 3 or 4 PLMA .
METHODS	The insertion time , success rate , seal pressure , hemodynamic variables , and complications , such as blood staining and sore throat , were evaluated .
RESULTS	The incidence of blood staining was lower with the size 3 PLMA compared to the size 4 PLMA ( 18 vs. 36 % ; P = 0.028 ) .
RESULTS	Compared with the size 3 LMA , the size 4 PLMA resulted in higher fluctuations in both blood pressure ( P = 0.003 ) and heart rate ( P = 0.01 ) .
RESULTS	The insertion time was shorter with the size 3 PLMA ( 9 vs. 16s ; P < 0.001 ) .
RESULTS	The airway seal pressure with the size 3 PLMA , although lower than that of the size 4 PLMA ( 23 vs. 28 cmH2O ; P = 0.001 ) , was sufficient for spontaneous ventilation .
CONCLUSIONS	Due to the reduced incidence of mucosal injury and greater hemodynamic stability , the size 3 PLMA may be preferable to the size 4 PLMA for non-paralyzed females .

###25595565
BACKGROUND	Asymptomatic hyperuricemia increases renal and cardiovascular ( CV ) risk .
BACKGROUND	We previously conducted a 2-year , single-blind , randomized , controlled trial of allopurinol treatment that showed improved estimated glomerular filtration rate and reduced CV risk .
METHODS	Post hoc analysis of a long-term follow-up after completion of the 2-year trial .
METHODS	113 participants ( 57 in the allopurinol group and 56 in the control group ) initially followed up for 2 years and 107 participants followed up to 5 additional years .
METHODS	Continuation of allopurinol treatment , 100mg/d , or standard treatment .
RESULTS	Renal event ( defined as starting dialysis therapy and/or doubling serum creatinine and/or 50 % decrease in estimated estimated glomerular filtration rate ) and CV events ( defined as myocardial infarction , coronary revascularization or angina pectoris , congestive heart failure , cerebrovascular disease , and peripheral vascular disease ) .
RESULTS	During initial follow-up , there were 2 renal and 7 CV events in the allopurinol group compared with 6 renal and 15 CV events in the control group .
RESULTS	In the long-term follow-up period , 12 of 56 participants taking allopurinol stopped treatment and 10 of 51 control participants received allopurinol .
RESULTS	During long-term follow-up , an additional 7 and 9 participants in the allopurinol group experienced a renal or CV event , respectively , and an additional 18 and 8 participants in the control group experienced a renal or CV event , respectively .
RESULTS	Thus , during the initial and long-term follow-up ( median , 84 months ) , 9 patients in the allopurinol group had a renal event compared with 24 patients in the control group ( HR , 0.32 ; 95 % CI , 0.15-0 .69 ; P = 0.004 ; adjusted for age , sex , baseline kidney function , uric acid level , and renin-angiotensin-aldosterone system blockers ) .
RESULTS	Overall , 16 patients treated with allopurinol experienced CV events compared with 23 in the control group ( HR , 0.43 ; 95 % CI , 0.21-0 .88 ; P = 0.02 ; adjusted for age , sex , and baseline kidney function ) .
CONCLUSIONS	Small sample size , single center , not double blind , post hoc follow-up and analysis .
CONCLUSIONS	Long-term treatment with allopurinol may slow the rate of progression of kidney disease and reduce CV risk .

###24313236
OBJECTIVE	This investigation compared cotinine ( primary metabolite of nicotine ) at study intake to self-report metrics ( e.g. , Fagerstrom Test of Nicotine Dependence [ FTND ] ) and assessed their relative ability to predict smoking outcomes .
METHODS	We used data from an analog model of contingency management for cigarette smoking .
METHODS	Non-treatment seeking participants ( N = 103 ) could earn money in exchange for provision of a negative carbon monoxide ( CO ) sample indicating smoking abstinence , but were otherwise not motivated to quit .
METHODS	We used intake cotinine , FTND , percent of friends who smoke , and years smoked to predict longitudinal CO and attendance , time-to-first positive CO submission , and additional cross-sectional outcomes .
RESULTS	Intake cotinine was consistently predictive ( p < .05 ) of all outcomes ( e.g. , longitudinal CO and attendance , 100 % abstinence , time-to-first positive CO sample ) , while years smoked was the only self-report metric that demonstrated any predictive ability .
CONCLUSIONS	Cotinine could be more informative for tailoring behavioral treatments compared to self-report measures .

###25646326
BACKGROUND	Tocopherols were discovered for their role in animal reproduction , but little is known about the contribution of deficiencies of vitamin E to human pregnancy loss .
OBJECTIVE	We sought to determine whether higher first-trimester concentrations of - tocopherol and - tocopherol were associated with reduced odds of miscarriage ( pregnancy losses < 24 wk of gestation ) in women in rural Bangladesh .
METHODS	A case-cohort study in 1605 pregnant Bangladeshi women [ median ( IQR ) gestational age : 10 wk ( 8-13 wk ) ] who participated in a placebo-controlled vitamin A - or - carotene-supplementation trial was done to assess ORs of miscarriage in women with low - tocopherol ( < 12.0 mol/L ) and - tocopherol ( < 0.81 mol/L ; upper tertile cutoff of the - tocopherol distribution in women who did not miscarry ) .
RESULTS	In all women , plasma - and - tocopherol concentrations were low [ median ( IQR ) : 10.04 mol/L ( 8.07-12 .35 mol/L ) and 0.66 mol/L ( 0.50-0 .95 mol/L ) , respectively ] .
RESULTS	In a logistic regression analysis that was adjusted for cholesterol and the other tocopherol , low - tocopherol was associated with an OR of 1.83 ( 95 % CI : 1.04 , 3.20 ) , whereas a low - tocopherol concentration was associated with an OR of 0.62 ( 95 % CI : 0.41 , 0.93 ) for miscarriage .
RESULTS	Subgroup analyses revealed that opposing ORs were evident only in women with BMI ( in kg/m ( 2 ) ) 18.5 and serum ferritin concentration 150 g/L , although low BMI and elevated ferritin conferred stronger risk of miscarriage .
CONCLUSIONS	In pregnant women in rural Bangladesh , low plasma - tocopherol was associated with increased risk of miscarriage , and low - tocopherol was associated with decreased risk of miscarriage .
CONCLUSIONS	Maternal vitamin E status in the first trimester may influence risk of early pregnancy loss .
CONCLUSIONS	The JiVitA-1 study , from which data for this report were derived , was registered at clinicaltrials.gov as NCT00198822 .

###24240315
BACKGROUND	The routine use of neuromuscular blocking agents reduces the occurrence of unacceptable surgical conditions .
BACKGROUND	In some surgeries , such as retroperitoneal laparoscopies , deep neuromuscular block ( NMB ) may further improve surgical conditions compared with moderate NMB .
BACKGROUND	In this study , the effect of deep NMB on surgical conditions was assessed .
METHODS	Twenty-four patients undergoing elective laparoscopic surgery for prostatectomy or nephrectomy were randomized to receive moderate NMB ( train-of-four 1-2 ) using the combination of atracurium/mivacurium , or deep NMB ( post-tetanic count 1-2 ) using high-dose rocuronium .
METHODS	After surgery , NMB was antagonized with neostigmine ( moderate NMB ) , or sugammadex ( deep NMB ) .
METHODS	During all surgeries , one surgeon scored the quality of surgical conditions using a five-point surgical rating scale ( SRS ) ranging from 1 ( extremely poor conditions ) to 5 ( optimal conditions ) .
METHODS	Video images were obtained and 12 anaesthetists rated a random selection of images .
RESULTS	Mean ( standard deviation ) SRS was 4.0 ( 0.4 ) during moderate and 4.7 ( 0.4 ) during deep NMB ( P < 0.001 ) .
RESULTS	Moderate block resulted in 18 % of scores at the low end of the scale ( Scores 1-3 ) ; deep block resulted in 99 % of scores at the high end of the scale ( Scores 4 and 5 ) .
RESULTS	Cardiorespiratory conditions were similar during and after surgery in both groups .
RESULTS	Between anaesthetists and surgeon , there was poor agreement between scores of individual images ( average statistic 0.05 ) .
CONCLUSIONS	Application of the five-point SRS showed that deep NMB results in an improved quality of surgical conditions compared with moderate block in retroperitoneal laparoscopies , without compromise to the patients ' peri - and postoperative cardiorespiratory conditions .
CONCLUSIONS	Trial registration The study was registered at clinicaltrials.gov under number NCT01361149 .

###24792311
OBJECTIVE	To determine if injection of local anesthetic into trocar insertion sites after laparoscopy improves postoperative pain .
METHODS	A prospective , 2-arm , randomized , double-blind , stratified , and controlled trial ( Canadian Task Force classification I ) .
METHODS	A university-based teaching hospital .
METHODS	This study was performed on women who had a laparoscopic gynecologic procedure for benign indications from March 2013 to June 2013 .
METHODS	One hundred thirty-five subjects were stratified by chronic pelvic pain or no chronic pelvic pain .
METHODS	Chronic pelvic pain was defined as pelvic pain occurring for 6 months or more in duration .
METHODS	Randomization was performed for this trial , with 68 receiving a bupivacaine block and 67 receiving no bupivacaine block .
METHODS	Of the 71 patients with chronic pelvic pain , 35 patients were in group 1 ( i.e. , bupivacaine block ) and 36 patients were in group 2 ( i.e. , no bupivacaine block ) .
METHODS	After the laparoscopic surgery was completed , the trocar incision sites were closed .
METHODS	For subjects randomized to receive a local anesthesia block , bupivacaine ( 0.25 % ) was injected .
METHODS	Incisions 8 mm or greater were injected with 10 mL 0.25 % bupivacaine .
METHODS	Incisions 5 mm or less were infiltrated with 5 mL .
METHODS	Injecting the local anesthetic through all preperitoneal layers provided a full-thickness local injection .
METHODS	Group 2 did not receive a local injection .
RESULTS	At the preoperative suite , the nurses gauged the patient 's pain using the Numeric Rating Scale .
RESULTS	This score was used as the baseline pain level with which the postoperative pain scores were compared .
RESULTS	The primary objective was to measure changes in pain scores , from preoperative to postoperative time frames of 2 to 4 hours , 6 to 8 hours , 18 to 24 hours , and 3 to 7 days postoperatively .
RESULTS	These score changes were measured as the main objective .
RESULTS	Secondary objectives include estimated blood loss , operating time , length of hospital stay , and histopathologic diagnosis .
RESULTS	The hospital personnel caring for the patient during the preoperative and postoperative course were given standard pain evaluation protocols .
RESULTS	All study pain evaluators and patients were blinded to treatment assignments throughout the pain assessment process .
RESULTS	There were no statistically significant differences in patient characteristics between the 2 treatment groups .
RESULTS	No significant difference was found in secondary outcomes including estimated blood loss , length of hospital stay , and histopathologic diagnosis .
RESULTS	In general , Numeric Rating Scale pain scores were lower ( i.e. , less pain ) in the `` bupivacaine block '' group compared with the `` no bupivacaine '' block group at the following postsurgery time assessments : 2 to 4 hours , 6 to 8 hours , 18 to 24 hours , and 3 to 7 days after surgery .
RESULTS	However , the effect was not large enough ( < 1 point ) to show a statistical difference between the treatment groups at any of these postsurgery assessments .
CONCLUSIONS	The postoperative injection of bupivacaine in trocar port sites did not significantly improve pain scores after laparoscopic gynecologic surgery .

###24898552
OBJECTIVE	The aim of this study was to determine long-term results of renal artery denervation for treatment of treatment-resistant hypertension in the SYMPLICITY HTN-2 study .
METHODS	SYMPLICITY HTN-2 randomized 106 subjects with treatment-resistant hypertension to renal denervation or medical therapy alone .
METHODS	At 6 months , 37 control subjects crossed over to renal denervation .
METHODS	Office blood pressure measurements , antihypertensive medication use , and safety events were followed every 6 months through 3 years .
RESULTS	Follow-up was available at 36 months in 40 of 52 subjects in the initial renal denervation group and at 30 months in 30 of 37 subjects who crossed over and received renal denervation at 6 months .
RESULTS	Baseline blood pressure was 184 19/99 16 mmHg in all treated subjects .
RESULTS	At 30-month post-procedure , systolic blood pressure decreased 34 mmHg ( 95 % CI : -40 , -27 , P < 0.01 ) and diastolic blood pressure decreased 13 mmHg ( 95 % CI : -16 , -10 , P < 0.01 ) .
RESULTS	The systolic and diastolic blood pressure reduction at 36 months for the initial renal denervation group was -33 mmHg ( 95 % CI : -40 , -25 , P < 0.01 ) and -14 mmHg ( 95 % CI : -17 , -10 , P < 0.01 ) , respectively .
RESULTS	Procedural complications included one haematoma , and one renal artery dissection before energy delivery that was treated successfully .
RESULTS	Later complications included two cases of acute renal failure , which fully resolved , 15 hypertensive events requiring hospitalization , and three deaths .
CONCLUSIONS	Renal denervation resulted in sustained lowering of blood pressure at 3 years in a selected population of subjects with severe , treatment-resistant hypertension without serious safety concerns .
BACKGROUND	NCT00888433 .

###24261806
OBJECTIVE	To compare onset time and quality of sedation achieved by IM injection of hydromorphone and dexmedetomidine into either the semimembranosus , cervical , gluteal , or lumbar muscle groups in dogs .
METHODS	Prospective , randomized , crossover study .
METHODS	7 dogs .
METHODS	Each dog was assigned to receive each treatment in random order , and at least 1 week elapsed between treatments .
METHODS	Dogs were sedated with dexmedetomidine and hydromorphone combined and injected IM into the assigned muscle group .
METHODS	An observer unaware of group assignments assessed physiologic variables every 5 minutes for 30 minutes , and a videographic recording was obtained .
METHODS	Recordings were evaluated by 16 individuals who were unaware of group assignments ; these reviewers assessed time to onset of sedation and assigned a sedation score to each dog every 5 minutes .
RESULTS	Resting pulse and respiratory rates did not differ among injection site groups .
RESULTS	The semimembranosus site had a significantly higher sedation score than all other sites , and the cervical site had a significantly higher sedation score than the lumbar and gluteal sites .
RESULTS	The semimembranosus and cervical sites had significantly shorter time to onset of sedation than did the gluteal and lumbar sites .
CONCLUSIONS	When the combination of dexmedetomidine and hydromorphone was used to induce sedation in dogs , rapid and profound sedation was achieved with IM injection into the semimembranosus muscle .

###25472808
BACKGROUND	Despite the laparoscopic approach becoming the standard in colorectal surgery , postoperative pain management for minimally invasive surgery is still mainly based on strategies that have been established for open surgical procedures .
BACKGROUND	Patient-controlled epidural and intravenous analgesia are considered standard postoperative analgesia regimens in colorectal surgery .
BACKGROUND	Epidural analgesia provides excellent analgesia , but is increasingly scrutinized in laparoscopic surgery since postoperative pain after the laparoscopic approach is significantly reduced .
BACKGROUND	Moreover , epidural analgesia can be associated with numerous complications .
BACKGROUND	Therefore , epidural analgesia is no longer recommended for the management of postoperative pain in laparoscopic colorectal surgery .
BACKGROUND	Likewise , patient-controlled intravenous analgesia is subject to significant side effects .
BACKGROUND	Given these important limitations of the traditional strategies for postoperative analgesia , effective and efficient alternatives in patients undergoing laparoscopic colorectal surgery are needed .
BACKGROUND	Both the transversus abdominis plane block and systemically administered lidocaine have already been reported to effectively reduce pain after laparoscopic colorectal surgery .
BACKGROUND	We hypothesize that the transversus abdominis plane block is superior to perioperative intravenous lidocaine .
METHODS	One hundred and twenty five patients undergoing laparoscopic colorectal surgery will be included in this prospective , randomized , double-blind controlled clinical trial .
METHODS	Patients will be randomly allocated to three different postoperative strategies : postoperative patient-controlled intravenous analgesia with morphine ( control group , n = 25 ) , a transversus abdominis plane block with ropivacaine 0.375 % at the end of surgery plus postoperative patient-controlled intravenous analgesia with morphine ( TAP group , n = 50 ) , or perioperative intravenous lidocaine plus postoperative patient-controlled intravenous analgesia with morphine ( LIDO group , n = 50 ) .
METHODS	As the primary outcome parameter , we will evaluate the opioid consumption during the first 24 postoperative hours .
METHODS	Secondary endpoints include the Numeric Rating Scale , time to return of intestinal function , time to mobilization , inflammatory response , incidence of postoperative nausea and vomiting , length of hospital stay and postoperative morbidity as assessed with the Clavien-Dindo classification .
CONCLUSIONS	Recognizing the importance of a multimodal approach for perioperative pain management , we aim to investigate whether a transversus abdominis plane block delivers superior pain control in comparison to perioperative intravenous lidocaine and patient-controlled intravenous analgesia with morphine alone .
BACKGROUND	EudraCT Identifier : 2014-001499-73 ; 31 July 2014 .

###25160775
BACKGROUND	Musculoskeletal disorders are the most frequent occupational diseases in Europe .
BACKGROUND	However , their multifactorial aetiology poses several challenges concerning not only the estimation of relative prevalence rates across occupational groups but also how the co-occurrence of known risk factors might differ between disorders of the upper and lower limbs .
BACKGROUND	Against this background , the following objectives are pursued : ( 1 ) to estimate the relative odds and prevalence rates of self-reported disorders of the upper limbs and/or shoulders and neck ( upper body ) and the lower limbs for major ISCO-88 occupational groups , ( 2 ) to evaluate to what extent the associations between known risk factors differ for musculoskeletal disorders of the upper body and the lower limbs .
METHODS	Statistical analysis of cross-sectional data from the European Working Conditions Survey 1995-2010 .
METHODS	The probability of reporting upper body and lower limbs pain in the survey sample 2010 is estimated by mixed logistic regression models using the Markov chain Monte Carlo Sampler .
METHODS	Independent variables include some known physical and psychosocial risk factors .
RESULTS	Concerning the first objective , an excess risk of reporting musculoskeketal disorders of the upper body was observed among craft workers ( ISCO 7 ) , machine operators ( ISCO 8 ) and workers in elementary occupations ( ISCO 9 ) .
RESULTS	Concerning musculoskeletal disorders of the lower limbs , service and sales workers ( ISCO 5 ) and workers in ISCO groups 7 , 8 and 9 reported symptoms more frequently .
RESULTS	Regarding the second objective , similar association patterns were observed for upper body and lower limbs symptoms .
RESULTS	Major physical risk factors associated with both symptom types were very frequent exposure to tiring positions , carrying heavy loads and performing repetitive tasks .
RESULTS	Standing appears to be an important risk factor for lower limbs symptoms only .
CONCLUSIONS	Results suggest that the unequal burden of exposure has not changed substantially across occupational groups since 1995 , and that there is urgent need of delivering and evaluating the effects of specific interventions targeting workers at high risk of developing musculoskeletal disorders .

###25175478
BACKGROUND	Medical conditions are often complicated by major depression , with consequent additional impairment of quality of life .
BACKGROUND	We aimed to compare the effectiveness of an integrated treatment programme for major depression in patients with cancer ( depression care for people with cancer ) with usual care .
METHODS	SMaRT Oncology-2 is a parallel-group , multicentre , randomised controlled effectiveness trial .
METHODS	We enrolled outpatients with major depression from three cancer centres and their associated clinics in Scotland , UK .
METHODS	Participants were randomly assigned in a 1:1 ratio to the depression care for people with cancer intervention or usual care , with stratification ( by trial centre ) and minimisation ( by age , primary cancer , and sex ) with allocation concealment .
METHODS	Depression care for people with cancer is a manualised , multicomponent collaborative care treatment that is delivered systematically by a team of cancer nurses and psychiatrists in collaboration with primary care physicians .
METHODS	Usual care is provided by primary care physicians .
METHODS	Outcome data were collected up until 48 weeks .
METHODS	The primary outcome was treatment response ( 50 % reduction in Symptom Checklist Depression Scale [ SCL-20 ] score , range 0-4 ) at 24 weeks .
METHODS	Trial statisticians and data collection staff were masked to treatment allocation , but participants could not be masked to the allocations .
METHODS	Analyses were by intention to treat .
METHODS	This trial is registered with Current Controlled Trials , number ISRCTN40568538 .
RESULTS	500 participants were enrolled between May 12 , 2008 , and May 13 , 2011 ; 253 were randomly allocated to depression care for people with cancer and 247 to usual care .
RESULTS	143 ( 62 % ) of 231 participants in the depression care for people with cancer group and 40 ( 17 % ) of 231 in the usual care group responded to treatment : absolute difference 45 % ( 95 % CI 37-53 ) , adjusted odds ratio 85 ( 95 % CI 55-134 ) , p < 00001 .
RESULTS	Compared with patients in the usual care group , participants allocated to the depression care for people with cancer programme also had less depression , anxiety , pain , and fatigue ; and better functioning , health , quality of life , and perceived quality of depression care at all timepoints ( all p < 005 ) .
RESULTS	During the study , 34 cancer-related deaths occurred ( 19 in the depression care for people with cancer group , 15 in the usual care group ) , one patient in the depression care for people with cancer group was admitted to a psychiatric ward , and one patient in this group attempted suicide .
RESULTS	None of these events were judged to be related to the trial treatments or procedures .
CONCLUSIONS	Our findings suggest that depression care for people with cancer is an effective treatment for major depression in patients with cancer .
CONCLUSIONS	It offers a model for the treatment of depression comorbid with other medical conditions .
BACKGROUND	Cancer Research UK and Chief Scientist Office of the Scottish Government .

###24962326
BACKGROUND	Buprenorphine is a promising treatment for heroin addiction .
BACKGROUND	However , little is known regarding its provision to pre-release prisoners with heroin dependence histories who were not opioid-tolerant , the relative effectiveness of the post-release setting in which it is provided , and gender differences in treatment outcome in this population .
METHODS	This is the first randomized clinical trial of prison-initiated buprenorphine provided to male and female inmates in the US who were previously heroin-dependent prior to incarceration .
METHODS	A total of 211 participants with 3-9 months remaining in prison were randomized to one of four conditions formed by crossing In-Prison Treatment Condition ( received buprenorphine vs. counseling only ) and Post-release Service Setting ( at an opioid treatment center vs. a community health center ) .
METHODS	Outcome measures were : entered prison treatment ; completed prison treatment ; and entered community treatment 10 days post-release .
RESULTS	There was a significant main effect ( p = .006 ) for entering prison treatment favoring the In-Prison buprenorphine Treatment Condition ( 99.0 % vs. 80.4 % ) .
RESULTS	Regarding completing prison treatment , the only significant effect was Gender , with women significantly ( p < .001 ) more likely to complete than men ( 85.7 % vs. 52.7 % ) .
RESULTS	There was a significant main effect ( p = .012 ) for community treatment entry , favoring the In-Prison buprenorphine Treatment Condition ( 47.5 % vs. 33.7 % ) .
CONCLUSIONS	Buprenorphine appears feasible and acceptable to prisoners who were not opioid-tolerant and can facilitate community treatment entry .
CONCLUSIONS	However , concerns remain with in-prison treatment termination due to attempted diversion of medication .

###24619855
OBJECTIVE	We evaluated the efficacy of sub-Tenon block in decreasing perioperative pain , incidence of intraoperative oculocardiac reflex ( OCR ) , and postoperative nausea and vomiting ( PONV ) in pediatric squint surgery .
METHODS	A total of 67 children age 2-12 years , American Society of Anesthesiologists Physical Status 1 and 2 , were randomized to receive either sub-Tenon block ( ST ) in the operative eye or 2 mcg/kg of intravenous fentanyl ( F ) for squint surgery after induction of general anesthesia in this double-blind study .
METHODS	Postoperative pain was measured by either modified Children 's Hospital of Eastern Ontario Pain Scale ( CHEOPS ) or Visual Analogue Scale ( VAS ) .
METHODS	Pain in the postoperative period ( up to 2 hours ) was measured as the primary endpoint .
METHODS	Other parameters measured in the groups were intraoperative hemodynamics , postoperative modified CHEOPS or VAS at shifting , 1 , 2 , 6 , 12 , and 24 hours after surgery , incidence of intraoperative OCR , and PONV at shifting , 30 minutes , 1 , 2 , 6 , 12 , and 24 hours after surgery .
RESULTS	There was no statistical difference in the postoperative pain scores in the recovery room up to 2 hours after surgery .
RESULTS	The VAS and CHEOPS scores were not different in the groups up to 24 hours after surgery .
RESULTS	The incidence of OCR was significantly higher in group F than group ST. The incidence of PONV was significantly higher in group F than group ST at 30 minutes and 1 hour after the surgery ( 41 % , 47 % vs 19 % , 9 % , respectively , p < 0.05 ) .
RESULTS	However , there was no statistically significant difference in intraoperative hemodynamics and PONV scores after 2 hours in the postanesthesia care unit .
CONCLUSIONS	Use of sub-Tenon block does not decrease the incidence of postoperative pain significantly in children undergoing squint surgery .
CONCLUSIONS	However , it leads to a statistically significant decrease in the incidence of intraoperative OCR and PONV in the early recovery period in these patients .

###24935040
OBJECTIVE	This study presents an interim safety and feasibility analysis of the REGENERATE-IHD randomized controlled trial , which is examining the safety and efficacy of three different delivery routes of bone marrow-derived stem cells ( BMSCs ) in patients with ischemic heart failure .
RESULTS	The first 58 patients recruited to the REGENERATE-IHD study are included in this interim analysis ( pilot ) .
RESULTS	Symptomatic patients with ischemic heart failure were randomized to receive subcutaneous granulocyte colony-stimulating factor or saline injections only ; or subcutaneous granulocyte colony-stimulating factor injections followed by intracoronary or intramyocardial injections of BMSCs or serum ( control ) .
RESULTS	No significant differences were found in terms of safety and feasibility between the different delivery routes , with no significant difference in procedural complications or major adverse cardiac events .
RESULTS	There was a signal towards improved heart failure symptoms in the patients treated with intramyocardial injection of mobilized BMSCs .
CONCLUSIONS	Peripheral mobilization of BMSCs with or without subsequent direct myocardial delivery appears safe and feasible in patients with chronic ischemic heart failure .

###25341145
OBJECTIVE	The purpose of this study was to prospectively evaluate the effect of benzyl alcohol , a common preservative in normal saline , on postprocedural pain after intraarticular injection for direct shoulder MR arthrography .
METHODS	From April 2011 through January 2013 , 138 patients underwent direct shoulder MR arthrography .
METHODS	Using the Wong-Baker Faces Pain Scale , patients were asked to report their shoulder pain level immediately before and immediately after the procedure and then were contacted by telephone 6 , 24 , and 48 hours after the procedure .
METHODS	Fourteen patients did not receive the prescribed amount of contrast agent for diagnostic reasons or did not complete follow-up .
METHODS	Sixty-two patients received an intraarticular solution including preservative-free normal saline ( control group ) and 62 patients received an intraarticular solution including normal saline with 0.9 % benzyl alcohol as a contrast diluent ( test group ) .
METHODS	Patients were randomized as to which intraarticular diluent they received .
METHODS	Fluoroscopic and MR images were reviewed for extracapsular contrast agent administration or extravasation , full-thickness rotator cuff tears , and adhesive capsulitis .
METHODS	The effect of preservative versus control on pain level was estimated with multiple regression , which included time after procedure as the covariate and accounted for repeated measures over patients .
RESULTS	Pain scale scores were significantly ( p = 0.0382 ) higher ( 0.79 units ; 95 % CI , 0.034-1 .154 ) with benzyl alcohol preservative compared with control ( saline ) .
RESULTS	In both study arms , the pain scale scores decreased slightly after the procedure , increased by roughly 1 unit over baseline for the test group and 0.3 unit over baseline for the control group by 6 hours after the procedure , were 0.50 unit over baseline for the test group and 0.12 unit over baseline for the control group at 24 hours , then fell to be slightly greater than baseline at 48 hours with benzyl alcohol and slightly less than baseline without benzyl alcohol .
RESULTS	These trends over time were highly significant ( p < 0.0001 ) .
CONCLUSIONS	Shoulder arthrography is often associated with postprocedural discomfort that begins immediately after the procedure and resolves by 48 hours .
CONCLUSIONS	There is significantly increased patient discomfort at 6 and 48 hours when using normal saline preserved with benzyl alcohol as a diluent compared with using normal saline without preservative as a diluent .

###24893955
OBJECTIVE	Antecedents of smoking have been widely researched in studies with older adults .
OBJECTIVE	However , less is known about the smoking patterns and antecedents of smoking in young adult smokers .
METHODS	In this study , we used ecological momentary assessment collected with an Internet-based survey instrument and used the participants ' own mobile phones to contrast the smoking patterns of young adult light and intermittent smokers ( n = 23 ) with heavy smokers ( n = 18 ) .
METHODS	Overall , 1543 smoking and non-smoking situations were analysed .
METHODS	By means of generalised estimating equations , we used a range of situational characteristics to predict smoking in both groups .
RESULTS	Craving and smoking of others increased the odds of smoking , and smoking bans were associated with a decreased probability of smoking among both light and intermittent smokers and heavy smokers .
RESULTS	Situational antecedents differed between both groups .
RESULTS	Cue-associated smoking played a bigger role for light and intermittent smokers than for heavy smokers .
RESULTS	Situational antecedents , such as craving , being at the home of others , drinking alcohol and smoking by others , were more strongly associated with the smoking of light and intermittent smokers compared with heavy smokers .
CONCLUSIONS	Smoking among young adults is associated with both internal and external situational characteristics .
CONCLUSIONS	Compared with heavy smokers , light and intermittent smoking seems to be under more stimulus control and more characterised by social smoking .
CONCLUSIONS	These results are consistent with several findings from previous studies and provide further information on different subgroups of smokers in early adulthood .

###25479348
OBJECTIVE	To compare the quality of data collection via electronic data capture ( EDC ) with voiced questionnaire ( QNN ) and data image capture features using a tablet versus standard paper-based QNN , to assess the user 's perception of using the EDC tool , and to compare user satisfaction with the two methods .
METHODS	Randomised cross-over study .
METHODS	Study sites : This study was conducted in two villages along the Thailand-Myanmar border .
METHODS	This study included 30 community health volunteers ( CHVs ) and 120 Karen hill tribe villagers .
METHODS	Employing a cross-over study design , the CHVs were allocated randomly to two groups , in which they performed interviews in different sequences using EDC and QNN .
RESULTS	Data discrepancies were found between the two data-collection methods , when data from the paper-based and image-capture methods were compared , and when conducting skip pattern questions .
RESULTS	More than 90 % of the CHVs perceived the EDC to be useful and easy to use .
RESULTS	Both interviewers and interviewees were more satisfied with the EDC compared with QNN in terms of format , ease of use , and system speed .
CONCLUSIONS	The EDC can effectively be used as an alternative method to paper-based QNNs for data collection .
CONCLUSIONS	It produces more accurate data that can be considered evidence-based .

###25344736
BACKGROUND	Despite persistent calls to measure the effectiveness of educational interventions on patient outcomes , few studies have been conducted .
BACKGROUND	Within musculoskeletal physiotherapy , the effects of postgraduate clinical mentoring on physiotherapist performance have been assessed , but the impact of this mentoring on patient outcomes remains unknown .
BACKGROUND	The objective of this trial is to assess the effectiveness of a work-based mentoring programme to facilitate physiotherapist clinical reasoning on patient outcomes in musculoskeletal physiotherapy .
METHODS	A stepped wedge cluster randomised controlled trial ( CRCT ) has been designed to recruit a minimum of 12 senior physiotherapists who work in musculoskeletal outpatient departments of a large National Health Service ( NHS ) organization .
METHODS	Participating physiotherapists will be randomised by cluster to receive the intervention at three time periods .
METHODS	Patients will be blinded to whether their physiotherapist has received the intervention .
METHODS	The primary outcome measure will be the Patient-Specific Functional Scale ; secondary outcome measures will include the EQ-5D , patient activation , patient satisfaction and physiotherapist performance .
METHODS	Sample size considerations used published methods describing stepped wedge designs , conventional values of 0.80 for statistical power and 0.05 for statistical significance , and pragmatic groupings of 12 participating physiotherapists in three clusters .
METHODS	Based on an intergroup difference of 1.0 on the PSFS with a standard deviation of 2.0 , 10 patients are required to complete outcome measures per physiotherapist , at time period 1 ( prior to intervention roll-out ) and at each of time periods 2 , 3 and 4 , giving a sample size of 480 patients .
METHODS	To account for the potential loss to follow-up of 33 % , 720 sets of patient outcomes will be collected.All physiotherapist participants will receive 150 hours of mentored clinical practice as the intervention and usual in-service training as control .
METHODS	Consecutive , consenting patients attending treatment by the participating physiotherapists during data collection periods will complete outcome measures at baseline , discharge and 12 months post-baseline .
METHODS	The lead researcher will be blinded to the allocation of the physiotherapist when analyzing outcome data ; statistical analysis will involve classical linear models incorporating both an intervention effect and a random intercept term to reflect systematic differences among clusters .
BACKGROUND	Assigned 31 July 2012 : ISRCTN79599220 .

###24878827
BACKGROUND	Walking and yoga have been independently evaluated for weight control ; however , there are very few studies comparing the 2 with randomization .
METHODS	The present study compared the effects of 90 minutes/day for 15 days of supervised yoga or supervised walking on : ( i ) related biochemistry , ( ii ) anthropometric variables , ( iii ) body composition , ( iv ) postural stability , and ( v ) bilateral hand grip strength in overweight and obese persons .
METHODS	Sixty-eight participants , of whom 5 were overweight ( BMI 25 kg/m2 ) and 63 were obese ( BMI 30 kg/m2 ; group mean age S.D. , 36.411.2 years ; 35 females ) , were randomized as 2 groups - ( i ) a yoga group and ( ii ) a walking group - given the same diet .
RESULTS	All differences were pre-post changes within each group .
RESULTS	Both groups showed a significant ( p < 0.05 ; repeated measures ANOVA , post-hoc analyses ) decrease in : BMI , waist circumference , hip circumference , lean mass , body water , and total cholesterol .
RESULTS	The yoga group increased serum leptin ( p < 0.01 ) and decreased LDL cholesterol ( p < 0.05 ) .
RESULTS	The walking group decreased serum adiponectin ( p < 0.05 ) and triglycerides ( p < 0.05 ) .
CONCLUSIONS	Both yoga and walking improved anthropometric variables and serum lipid profile in overweight and obese persons .
CONCLUSIONS	The possible implications are discussed .

###24673513
OBJECTIVE	Benvitimod is a newly synthesized non-steroidal small molecule , aimed at the treatment for psoriasis .
OBJECTIVE	Several trials have demonstrated that benvitimod improves plaque psoriasis .
OBJECTIVE	However , its maximum tolerated dose and pharmacokinetic characteristics have not been reported on .
OBJECTIVE	The goals of this study were to evaluate the safety , tolerability and pharmacokinetics of benvitimod after topical administration in healthy subjects .
METHODS	This phase I trial in healthy subjects was designed as a randomized , double-blind , placebo-controlled , ascending-dose study .
METHODS	After screening and randomization , 56 volunteers received benvitimod ( 05-20 % ) or placebo cream once or twice daily .
METHODS	Doses were escalated from 5 to 30mg daily in six cohorts .
METHODS	Safety and tolerability were appraised by monitoring adverse events and laboratory parameters .
METHODS	Benvitimod concentrations were measured using liquid chromatography-tandem-mass spectrometry .
CONCLUSIONS	Exposure to benvitimod did not result in electrocardiographic or clinical laboratory changes .
CONCLUSIONS	Doses up to 30mg were well tolerated .
CONCLUSIONS	All adverse events were mild .
CONCLUSIONS	Adverse effects at the application site were observed in subjects randomized to benvitimod 5mg q.d and b.i.d , but there were no observable dose effects in the dose-range evaluated .
CONCLUSIONS	Benvitimod was detected in fewer than 5 % of the plasma samples .
CONCLUSIONS	Benvitimod cream , at single doses of up to 30mg , is well tolerated by healthy subjects .
CONCLUSIONS	Following topical application , systemic absorption was negligible .

###24495046
OBJECTIVE	Currently available preparations for colonoscopy have low tolerability and may cause fluid and electrolyte shifts .
OBJECTIVE	An alternative method of bowel cleansing is required .
METHODS	Preparation of the gut using oral nutritional supplements ( ONS ) and rectal enema was tested as an alternative method of bowel cleansing .
METHODS	During 2008-2012 , patients were randomized to oral nutritional supplements ( n = 27 ) for 5 days and rectal enema or polyethylene glycol ( PEG ) ( n = 23 ) prior to colonoscopy .
METHODS	Blinded endoscopists rated the degree of bowel cleansing according to the Ottawa bowel preparation scale ( OBS ) ( primary outcome ) .
METHODS	Tolerability of either preparation was also assessed ( ClinicalTrials.gov .
METHODS	Identifier no : NCT00123456 ) .
RESULTS	Due to a high rate of bowel cleansing failure among patients receiving ONS , the study was interrupted prematurely .
RESULTS	Colonoscopies were incomplete due to stools in 6 of 27 patients in the ONS group compared to 1 of 23 in the PEG group ( ns ) .
RESULTS	The mean total OBS were 8.3 3.3 and 5.3 2.8 , respectively ( p = 0.002 ) .
RESULTS	Four patients ( 15 % ) in the ONS group and eight patients ( 35 % ) receiving PEG had an OBS score 4 ( good preparation ) ( ns ) .
RESULTS	ONS was better tolerated than PEG with more patients reporting acceptable taste ( 27 of 27 [ 100 % ] vs. 15 of 23 [ 65 % ] , p = 0.001 ) , and fewer reporting difficulties with the intake ( 0 of 27 [ 0 % ] vs. 10 of 23 [ 43 % ] , p < 0.001 ) and nausea ( 5 of 27 [ 19 % ] vs. 13 of 23 [ 57 % ] , p < 0.008 ) .
CONCLUSIONS	For routine use , ONS with enema instead of traditional preparation for colonoscopy with PEG can not be generally recommended .

###25628188
OBJECTIVE	To compare the efficacy and safety of a new porcine-derived pulmonary surfactant developed by Instituto Butantan with those of animal-derived surfactants commercially available in Brazil , regarding neonatal mortality and the major complications of prematurity in preterm newborns with birth weight up to 1500g and diagnosed with respiratory distress syndrome .
METHODS	Neonates diagnosed with respiratory distress syndrome were randomized to receive either Butantan surfactant ( Butantan group ) or one of the following surfactants : Survanta or Curosurf .
METHODS	Newborns receiving Survanta or Curosurf comprised the control group .
METHODS	The main outcome measures were mortality rates at 72 hours and at 28 days of life ; the typical complications of prematurity as evaluated on the 28th day of life were defined as secundary outcomes .
RESULTS	No differences were observed between the Butantan ( n = 154 ) and control ( n = 173 ) groups in relation to birth weight , gestational age , sex , and prenatal use of corticosteroids , or in mortality rates both at 72 hours ( 14.19 % versus 14.12 % ; p = 0.98 ) and at 28 days ( 39.86 % versus 33.33 % ; p = 0.24 ) of life .
RESULTS	Higher 1 - and 5-minute Apgar scores were observed among control group newborns .
RESULTS	No differences were observed as regards the secondary outcomes , except for greater need for supplemental oxygen and a higher incidence of interstitial pulmonary emphysema in the Butantan group .
CONCLUSIONS	The mortality rates at 72 hours and 28 days of life and the incidence of major complications of prematurity were comparable to those found with the animal-derived surfactants commercially available in Brazil , showing the efficacy and safety of the new surfactant in the treatment of respiratory distress syndrome in newborns .

###25854575
OBJECTIVE	To explore the influence of cefodizime on CD4/CD8 and T helper 1 ( Th1 ) / Th2 cell ratios in peripheral blood of the senile patients with bacterial pneumonia .
METHODS	Sixty-three senile patients with bacterial pneumonia were enrolled and divided into two groups randomly .
METHODS	Patients in the control group ( n = 31 ) were given intravenous infusion of ceftriaxone sodium , and patients in the observation group ( n = 32 ) were given intravenous infusion of cefodizime .
METHODS	The fasting venous blood was taken before and after treatment to detect CD4/CD8 and Th1/Th2 cell ratios with flow cytometry .
METHODS	At the same time , the serum interleukin-2 ( IL-2 ) , interferon ( IFN - ) , IL-4 and IL-10 contents were also detected with ELISA .
RESULTS	Before treatment , there was no significant difference in the above indexes between the two groups .
RESULTS	After treatment , CD4 cells and Th1 cells of the observation group increased while Th2 cells decreased ; as a result , the CD4/CD8 and Th1/Th2 cell ratios of the observation group were significantly higher than those of the control group .
RESULTS	At the same time , serum IL-2 and IFN - contents of the observation group were significantly higher than those of the control group , while serum IL-4 and IL-10 contents were significantly lower than those of the control group .
CONCLUSIONS	Cefodizime can improve the cellular immune function and rectify CD4/CD8 and Th1/Th2 imbalance in peripheral blood of the senile patients with bacterial pneumonia .

###24438695
OBJECTIVE	The aim of this study was to evaluate the effects of radiotherapy plus concurrent weekly cisplatin chemotherapy on the postoperative recurrence of mediastinal lymph node metastases in esophageal cancer patients .
METHODS	Ninety-eight patients were randomly enrolled to receive either three-dimensional conformal radiotherapy alone ( group A ) or concurrent chemoradiotherapy ( group B ) .
METHODS	A radiation dose of 62-70 Gy/31 -35 fractions was delivered to the recurrent tumor .
METHODS	Furthermore , the patients in group B simultaneously received weekly doses of cisplatin ( 30 mg/m ( 2 ) ) , and the survival outcomes and toxic effects were compared .
RESULTS	The response rate of group B ( 91.8 % ) was significantly greater than that of group A ( 73.5 % ) ( ( 2 ) = 5.765 , P = 0.016 ) .
RESULTS	The 1 - and 3-year survival rates of group B ( 85.7 % and 46.9 % , respectively ) were also greater than those of group A ( 69.4 % and 28.6 % , respectively ) .
RESULTS	However , there were no significant differences in the 5-year survival rates .
RESULTS	The numbers of patients who died of distant metastases in groups A and B were 13 ( 26.5 % ) and 5 ( 10.2 % ) , respectively ( ( 2 ) = 4.356 , P = 0.036 ) .
RESULTS	Acute radiation-related esophagitis and granulocytopenia in group B was frequent .
RESULTS	However , intergroup differences in terms of late toxicity were not significant .
CONCLUSIONS	Three-dimensional conformal radiotherapy ( 3DCRT ) is a practical and feasible technique to treat the recurrence of mediastinal lymph node metastases of postoperative esophageal cancer .
CONCLUSIONS	In addition , concurrent chemotherapy can increase local tumor control , decrease the distant metastasis rate , and increase the long-term survival rate .

###24722423
BACKGROUND	No specific antiviral agent against hand foot and mouth disease ( HFMD ) is available for clinical practice today .
OBJECTIVE	To evaluate the efficacy and safety of Jinzhen oral solution in treating uncomplicated HFMD .
METHODS	In this randomized , double-blind , placebo-controlled trial , 399 children aged 1 to 7 years with laboratory confirmed HFMD were randomized to receive Jinzhen oral liquid or placebo 3 times daily for 7 days with a 3-day follow-up .
METHODS	The primary outcomes were time to the first disappearance of oral ulcers and vesicles on hand or foot and time to the first normalization of temperature ( fever clearance ) .
RESULTS	There were 199 children enrolling into the Jinzhen group including 79 with fever and 200 into the placebo group including 93 with fever .
RESULTS	Jinzhen reduced the time to the first disappearance of oral ulcers and vesicles on hand or foot to 4.9 days ( 95 % CI , 4.6 to 5.2 days ) , compared with 5.7 days ( 95 % CI , 5.4 to 6.0 days ) in the placebo group ( P = 0.0036 ) .
RESULTS	The median time of fever clearance was shorter in the 79 children who received Jinzhen ( 43.41 hrs , 95 % CI , 37.05 to 49.76 ) than that in the 93 children who received placebo ( 54.92 hrs , 95 % CI , 48.16 to 61.68 ) ( P = 0.0161 ) .
RESULTS	Moreover , Jinzhen reduced the risk of symptoms by 28.5 % compared with placebo ( HR , 0.7150 , 95 % CI , 0.5719 to 0.8940 , P = 0.0032 ) .
RESULTS	More importantly , treatment failure rate was significantly lower in the Jinzhen group ( 8.04 % ) compared with that in the placebo group ( 15.00 % ) ( P = 0.0434 ) .
RESULTS	The incidence of serious adverse events did not differ significantly between the two groups ( 9 in Jinzhen group vs. 18 in placebo , P = 0.075 ) .
CONCLUSIONS	Children with HFMD may benefit from Jinzhen oral liquid treatment as compared with placebo .
BACKGROUND	Chinese Clinical Trial Registry ( http://www.chictr.org/en/ ) ChiCTR-TRC-10000937 .

###25762758
BACKGROUND	This study examined overall changes in nicotine concentrations when using a popular e-cigarette and 18 mg/mL nicotine e-Juice , and it further explored effects of sex and flavorings on these concentrations .
METHODS	We recruited nontreatment-seeking smokers who were willing to try e-cigarettes for 2 weeks and abstain from cigarette smoking .
METHODS	Subjects were randomized to either menthol tobacco or non-menthol tobacco-flavored e-cigarette use for 7-10 days , and the next week they were crossed over to the other condition .
METHODS	On the last day of e-cigarette use of each flavor , subjects completed a laboratory session in which they used the e-cigarette for 5 min ad libitum .
METHODS	Nicotine concentrations were obtained 5 min before and 5 , 10 , 15 , 20 , and 30 min after the onset of e-cigarette use .
RESULTS	Twenty subjects completed at least 1 monitoring session .
RESULTS	Nicotine concentrations significantly increased from baseline to 5 min by 4 ng/mL at the first laboratory session ( p < .01 ) and by 5.1 ng/mL at the second laboratory session ( p < .01 ) .
RESULTS	Combining sessions , there were no main effects of sex or preferred flavor ( based on smoking history ) on changes in nicotine concentrations .
RESULTS	After adding preferred flavor , sex , and visit order to the model , there was a significant preferred flavor by sex interaction ( p < .01 ) , such that women who received nonpreferred flavors had lower nicotine concentrations and rated their e-cigarette as less likeable ( p < .01 ) .
CONCLUSIONS	We found nicotine concentrations significantly increase after e-cigarette use for 5 min , and flavor may impact nicotine concentrations with e-cigarette use in women .

###25091593
BACKGROUND	Depression is a common and disabling condition .
BACKGROUND	In Chile , assistance is guaranteed by law through a national program for depression in primary care services , and there is evidence of effective treatment for depressed women .
BACKGROUND	However , there is a shortage of evidence-based treatments for depression in adolescents .
BACKGROUND	The incorporation of technology to expand therapeutic options is becoming more common .
BACKGROUND	This proposal aims to compare the efficacy of therapy that enhances traditional face-to-face cognitive-behavioral therapy ( CBT ) with a computer-based program versus usual care to treat depression in adolescents in primary care clinics in Santiago , Chile .
METHODS	This is a two-arm , single-blind , randomized controlled trial with a target enrollment of 216 depressed adolescents between 15 and 19years of age , attending four primary care clinics in Santiago , Chile .
METHODS	In the active arm , depressed adolescents will receive eight sessions of computer-assisted CBT , led by trained psychologists on a weekly basis .
METHODS	In the control arm , depressed adolescents will receive treatment as usual from the primary care centers .
METHODS	Mean depression scores and indicators of dysfunctional thoughts , problem-solving strategies , and health-related quality of life will be measured at baseline and four and six months after randomization .
CONCLUSIONS	As far as we know , this is the first randomized controlled trial of a computer-assisted CBT intervention for depressed adolescents in a Latin American country .
BACKGROUND	Clinical Trials : NCT01862913 .

###25635925
OBJECTIVE	Fibromyalgia ( FM ) is a disease that causes widespread pain and increased sensitivity to pain because of a dysfunction in the central nervous system .
OBJECTIVE	This study investigated the effect of music combined with vibration on acupuncture points for the treatment of FM .
METHODS	A total of 120 patients with FM were allocated randomly to four groups ( 30 patients each ) .
METHODS	One group listened to a sequence of Bach 's compositions .
METHODS	The second group was subjected to vibratory stimuli on a combination of acupuncture points on the skin .
METHODS	The third group ( complete ) underwent both procedures in a simultaneous and synchronized manner , with inclusion of binaural beats .
METHODS	The fourth group ( control ) received no stimulation .
METHODS	The participants underwent the experimental procedure during five sessions performed on alternate days .
METHODS	They were assessed by the Fibromyalgia Impact Questionnaire ( FIQ ) and the Health Assessment Questionnaire ( HAQ ) before the first session and after the last session ( 20 days ) .
RESULTS	All groups showed a significant improvement in FIQ and HAQ scores at the evaluation after the intervention .
RESULTS	The complete group exhibited the best result on both the FIQ and HAQ ( p < 0.001 ) , and the improvement in HAQ score was significant ( p < 0.004 ) .
CONCLUSIONS	The results suggest that the placebo effect in FM may be substantial .
CONCLUSIONS	However , comparison between groups revealed that the complete group had the greatest reduction in both FIQ and HAQ , with a significant improvement in HAQ , suggesting that the combined use of music and vibration exerts a greater effect on FM symptoms .

###25131484
OBJECTIVE	To determine whether the extruded irrigation solution bag during passage of rigid cystoscope will reduce the patient 's discomfort .
METHODS	In the study , 378 male patients undergoing rigid cystoscopies were randomized into `` Institute of Urology Peking University ( IUPU ) '' technique group ( n = 193 ) and routine manipulation group ( n = 185 ) .
METHODS	All the patients had received 10 mL oxybuprocaine gel before manipulation .
METHODS	In the IUPU technique group , irrigation solution bag was connected with cystoscope sheath and obturator .
METHODS	As the scope passed through the bulbar urethra , a nurse was instructed to extrude the irrigating fluid bag .
METHODS	A 10-point visual analog pain scale assessment was completed by the patient after the procedure .
RESULTS	The visual analog pain score was 2 ( 1-2 ) in the IUPU technique group and 4 ( 3-6 ) in the routine manipulation group ( P < 0.001 , Mann-Whitney U test ) .
RESULTS	All the procedure indications had no effect on the findings .
CONCLUSIONS	This study has shown that a simple IUPU technique can significantly reduce the patient 's discomfort during outpatient rigid cystoscopy .
CONCLUSIONS	We strongly recommend this technique for all male patients undergoing rigid cystoscopy .

###24685561
BACKGROUND	Contingency management ( CM ) treatment is effective for treating cocaine dependence but further mechanistic studies of its efficacy are warranted .
BACKGROUND	This study aimed to determine whether : ( a ) higher vs. lower predictable money amounts ( $ 3 vs. $ 1 ; analogs of standard voucher-based CM ) increase cocaine demand elasticity ; and ( b ) probabilistic amounts matched for expected value with the $ 3-predictable amount ( 50 % chance of $ 6 ; 25 % chance of $ 12 ; and 12.5 % chance of $ 24 ; analogs of prize CM ) similarly affect cocaine choice .
METHODS	Each of 15 cocaine-dependent participants first completed a qualifying session to ensure that intranasal cocaine functioned as a reinforcer , then completed a 10-session , within-subject , randomized crossover study .
METHODS	During each of the 10 sessions , the participant responded on a progressive ratio schedule to earn units of cocaine ( 5-mg or 10-mg ) and/or money ( five monetary conditions above ) .
RESULTS	During the reinforcement qualifying session ( 10-mg vs. 0-mg units ; no money alternative ) , cocaine choice was high .
RESULTS	The $ 3-predictable amount significantly decreased cocaine choice relative to both the $ 1-predictable amount and the qualifying session .
RESULTS	Cocaine-choices in the probabilistic conditions were similar to the $ 3 predictable condition .
CONCLUSIONS	These findings indicate that CM interventions targeted at reducing cocaine self-administration are more likely to succeed with higher value non-drug reinforcement .

###24650820
OBJECTIVE	The purpose of this study was to evaluate associations between prescription drug misuse ( PDM ) and sexual risk behaviors ( SRBs ) among adolescents and emerging adults .
METHODS	In a hospital emergency department , 2,127 sexually active 14 - to 20-year-olds ( 61 % female ) reported on past-year alcohol use severity ( using the Alcohol Use Disorders Identification Test-consumption [ AUDIT-C ] ) , cannabis use , PDM ( n = 422 ) , and SRBs ( inconsistent condom use , multiple partners , intercourse following alcohol/other drug use ) .
RESULTS	Bivariately , AUDIT-C score , cannabis use , and PDM of stimulants , opioids , and sedatives were positively associated with each SRB .
RESULTS	Because many participants reported PDM for multiple drug classes ( i.e. , sedatives , stimulants , opioids ) , participants were categorized as ( a ) no PDM ( n = 1,705 ) , ( b ) PDM of one class ( n = 251 ) , ( c ) PDM of two classes ( n = 90 ) , or ( d ) PDM of three classes ( n = 81 ) .
RESULTS	Three hierarchical logistic regression models evaluated the associations of number of classes of PDM with SRBs separately , after accounting for demographics ( age , gender , race ) , AUDIT-C score , and cannabis use .
RESULTS	Adding PDM statistically improved each model beyond what was accounted for by demographics , alcohol , and cannabis use .
RESULTS	For inconsistent condom use and substance use before sex , PDM of one , two , or three classes was significantly associated with increased odds of these SRBs .
RESULTS	PDM of two or three classes was associated with increased odds of reporting multiple partners .
CONCLUSIONS	Findings suggest that PDM , especially poly-PDM , may be a pertinent risk factor for SRBs among youth .
CONCLUSIONS	Event-based research could further evaluate how PDM , as well as other substance use , is related to SRBs at the event level in order to inform interventions .

###25619519
BACKGROUND	Synthetic colloids are often used during fluid resuscitation and affect coagulation .
OBJECTIVE	To compare the effects of an isotonic crystalloid and synthetic colloid on coagulation in healthy dogs and dogs with systemic inflammation .
METHODS	Sixteen adult purpose-bred Beagles .
METHODS	Randomized , placebo-controlled , blinded study .
METHODS	Dogs were randomized into one of two groups receiving fluid resuscitation with either 40 mL/kg IV 0.9 % NaCl or tetrastarch after administration of lipopolysaccharide or an equal volume of placebo .
METHODS	After a 14-day washout period , the study was repeated such that dogs received the opposite treatment ( LPS or placebo ) but the same resuscitation fluid .
METHODS	Blood samples were collected at 0 , 1 , 2 , 4 , and 24 hours for measurement of coagulation variables .
RESULTS	Administration of either fluid to healthy dogs and dogs with systemic inflammation resulted in similar increases in prothrombin time and activated clotting time .
RESULTS	In comparison to saline administration , tetrastarch administration resulted in significantly decreased R ( P = .017 ) in healthy dogs , as well as significantly increased activated partial thromboplastin time ( P .016 ) , CL30 % ( P .016 ) , and K ( P < .001 ) and significantly decreased platelet count ( P = .019 ) , ( P .001 ) , MA ( P < .001 ) , and von Willebrand factor antigen ( P < .001 ) and collagen binding activity ( P .003 ) in both healthy dogs and dogs with systemic inflammation .
CONCLUSIONS	Tetrastarch bolus administration to dogs with systemic inflammation resulted in a transient hypocoagulability characterized by a prolonged activated partial thromboplastin time , decreased clot formation speed and clot strength , and acquired type 1 von Willebrand disease .

###25450123
OBJECTIVE	To evaluate the reduction in phantom pain and sensation with combined training of progressive muscle relaxation , mental imagery , and phantom exercises .
METHODS	Randomized controlled prospective trial with 2 parallel groups .
METHODS	Amputee unit of a rehabilitation hospital .
METHODS	Subjects with unilateral lower limb amputation ( N = 51 ) with phantom limb pain ( PLP ) and/or phantom limb sensation ( PLS ) .
METHODS	The experimental group performed combined training of progressive muscle relaxation , mental imagery , and phantom exercises 2 times/wk for 4 weeks , whereas the control group had the same amount of physical therapy dedicated to the residual limb .
METHODS	No pharmacological intervention was initiated during the trial period .
METHODS	The Prosthesis Evaluation Questionnaire and the Brief Pain Inventory were used to evaluate changes over time in different aspects ( intensity , rate , duration , and bother ) of PLS and PLP .
METHODS	Blind evaluations were performed before and after treatment and after 1-month follow-up .
RESULTS	The experimental group showed a significant decrease over time in all the Prosthesis Evaluation Questionnaire domains ( in terms of both PLS and PLP ; P < .04 for both ) and the Brief Pain Inventory ( P < .03 ) .
RESULTS	No statistically significant changes were observed in the control group .
RESULTS	Between-group analyses showed a significant reduction in intensity ( average and worst pain ) and bother of PLP and rate and bother of PLS at follow-up evaluation , 1 month after the end of the treatment .
CONCLUSIONS	Combined training of progressive muscle relaxation , mental imagery , and modified phantom exercises should be taken into account as a valuable technique to reduce phantom limb pain and sensation .

###25271180
BACKGROUND	Anxiety among patients in a pediatric emergency department ( PED ) can be significant , but often goes unaddressed .
OBJECTIVE	Our aim was to determine whether exposure to Child Life ( CL ) or hospital clowning ( HC ) can reduce anxiety in children presenting to a PED .
METHODS	Patients were randomized to CL , HC , or control and assessed upon entry to examination room ( T1 ) , before physician arrival ( T2 ) , and during physician examination ( T3 ) , using the modified Yale Preoperative Anxiety Scale ( m-YPAS ) .
METHODS	CL and HC interventions occurred for 5 to 10 min before physician entry .
METHODS	Effects were analyzed using mixed analysis of variance .
RESULTS	m-YPAS scores ranged from 23 to 59 , with a higher score indicating increased anxiety .
RESULTS	Mixed analysis of variance on the study sample ( n = 113 ) showed a significant interaction between groups ( CL , HC , control ) and time ( p = 0.02 ) .
RESULTS	Additional analyses indicated effect of group only at T2 ( CL : mean = 23.8 ; 95 % confidence interval [ CI ] 23.2-24 .5 ; HC : mean 25.2 ; 95 % CI 24.2-26 .2 ; control : mean = 26.1 ; 95 % CI 24.2-27 .9 ; p = .02 ) .
RESULTS	Subanalysis of patients with T1 m-YPAS score 28 ( n = 56 ) showed a significant interaction between group and time ( p = 0.01 ) .
RESULTS	Additional analysis showed effect of group only at T2 ( CL : mean 24.4 ; 95 % CI 23.3-25 .6 ; HC : mean 27.0 ; 95 % CI 25.2-28 .7 ; control : mean 29.2 ; 95 % CI 25.6-32 .7 ; p = 0.003 ) .
CONCLUSIONS	CL services can reduce state anxiety for patients presenting to a PED with heightened anxiety at baseline .
CONCLUSIONS	This reduction occurred immediately after CL intervention , but was not observed in patients exposed to HC or during physician examination .

###24619576
OBJECTIVE	Minimizing hemodynamic changes during the peri-intubation period is a concern for anesthesiologists .
OBJECTIVE	We investigated the effect of lidocaine sprayed on the laryngoscope blade and trachea on hemodynamics during direct laryngoscopic intubation .
METHODS	Seventy-two patients were randomly allocated to one of four groups : 10 % lidocaine was sprayed either on the laryngoscope blade ( group L ) , on the trachea ( group V ) , or on the laryngoscope blade and the trachea ( group LV ) .
METHODS	No lidocaine was used in group C. Anesthesia was induced in all patients with remifentanil ( effect site concentration : 4.0 ng/ml ) and propofol ( effect site concentration 4.0 g/ml ) continuous infusion using a target control infusion ( TCI ) device .
METHODS	Mean arterial pressure ( MAP ) and heart rate ( HR ) were recorded during the peri-intubation period .
RESULTS	Changes in MAP and HR over time were markedly different among the four groups ( P < 0.05 ) .
RESULTS	MAP at 1 min post-intubation was significantly lower in groups L , V , and LV than in group C ( 86.1 12.7 , 85.3 12.6 , and 83.7 13.1 vs. 106.3 22.9 mmHg , P < 0.01 ) .
RESULTS	Maximum MAP values were lower in groups L and LV than in group C ( P < 0.05 ) .
RESULTS	HRs at 1 , 2 , and 3 min post-intubation were lower in group LV than in group C ( 70.4 9.0 vs. 84.2 15.3 ; 64.0 8.1 vs. 79.2 15.4 ; 61.6 8.3 vs. 77.2 14.5 beats/min , P < 0.01 , respectively ) .
CONCLUSIONS	Lidocaine sprayed on the laryngoscope blade and/or trachea reduced the hemodynamic response to laryngoscopic intubation during the post-intubation period following anesthetic induction with remifentanil and propofol using a TCI device .

###24385635
OBJECTIVE	To examine basic and everyday cognitive predictors of older adults ' self-reported instrumental activities of daily living ( IADL ) .
METHODS	Basic and everyday cognitive predictors of self-reported IADL were examined in a sample of healthy , community-dwelling older adults ( n = 698 ) assessed over 5 years of measurement .
RESULTS	Multilevel longitudinal analyses revealed linear and quadratic change trends for self-reported IADL function , with steeper declines at higher ages .
RESULTS	Within-person , when participants exhibited lower cognitive performance , they also reported more IADL impairment .
RESULTS	Everyday cognition remained a significant unique predictor of self-reported IADL after controlling for attrition , resampling effects , temporal gradients , and baseline levels and changes in demographic , sensory , functional , and basic cognitive measures .
CONCLUSIONS	By itself , everyday cognition appears to be an important predictor of self-reported IADL , and maintains a unique predictive contribution after many covariates are controlled .
CONCLUSIONS	Future research should consider the inclusion of everyday cognitive measures in functional assessment batteries .

###24907946
BACKGROUND	Post-operative nasogastric intubation after emergency laparotomy is a common practice in many centers , with the intent of hastening the return of bowel function , relieving gastrointestinal discomfort , reducing various post-operative complications and reducing hospital stay .
BACKGROUND	However , bowel rest and gastric decompression have been re-examined in the light of more recent data .
BACKGROUND	Many studies and meta-analyses over the last 50 years have challenged the routine use of nasogastric tubes after laparotomy .
BACKGROUND	The objective of this study is to evaluate the need for routine nasogastric decompression after emergency laparotomy .
METHODS	A prospective , randomized controlled trial was conducted for 12 months ( May 1 , 2007 to Apr 30 , 2008 ) in the Department of Surgery , Tribhuvan University Teaching Hospital , after ethical approval .
METHODS	Patients were enrolled as per criteria ( Box 1 ) , and subsequently allocated by simple randomization into two groups : Group 1 and Group 2 .
METHODS	Patients undergoing emergency laparotomy for perforation peritonitis , intestinal obstruction and abdominal trauma were randomized to two groups - with or without nasogastric tube after surgery .
METHODS	Gastric upset , return of bowel function and postoperative complications were compared .
RESULTS	Total of 115 patients met the inclusion criteria .
RESULTS	There was no statistically significant difference in the occurrence of gastric upset ( P : 0.38 ) , wound complications ( P : 0.30 ) , respiratory complications ( P : 0.30 ) and anastomotic leak ( P : 0.64 ) between two groups .
RESULTS	Bowel function returned in comparable times in both groups ( correlation coefficient : 0.14 ; P : 0.54 ) .
RESULTS	Nasogastric tube had to be reinserted in three patients in the group with nasogastric decompression postoperatively , and four in the group without ( P : 0.43 ) .
RESULTS	Thus , routine nasogastric decompression neither prevented the development of gastrointestinal discomfort nor precluded the need for tube replacement once it was discontinued .
RESULTS	For every patient who required post-operative nasogastric decompression , at least 14 patients were spared one .
RESULTS	Mean hospital stay was significantly more in the decompressed group ( 7.52 days ; correlation coefficient : 0.22 ; P < 0.05 ) .
CONCLUSIONS	This study has shown that the prophylactic nasogastric decompression following emergency laparotomy is ineffective in achieving any of the intended goals .
BACKGROUND	complications ; decompression ; emergency laparotomy ; flatus ; nasogastric tube ; prophylactic .

###25209072
BACKGROUND	Childhood obesity rates in the U.S. have reached epidemic proportions , and an urgent need remains to identify evidence-based strategies for prevention and treatment .
BACKGROUND	Multi-level , multi-component interventions are needed due to the multi-factorial nature of obesity , and its proven links to both the social and built environment .
BACKGROUND	However , there are huge gaps in the literature related to doing these kinds of interventions among low-income , urban , minority groups .
METHODS	The B'More Healthy Communities for Kids ( BHCK ) intervention is a multi-level , multi-component intervention , targeting low-income African American youth ages 10-14 and their families in Baltimore , Maryland .
METHODS	This intervention prevents childhood obesity by working at multiple levels of the food and social environments to increase access to , demand for , and consumption of healthier foods .
METHODS	BHCK works to create systems-level change by partnering with city policy-makers , multiple levels of the food environment ( wholesalers , corner stores , carryout restaurants ) , and the social environment ( peers and families ) .
METHODS	In addition , extensive evaluation will be conducted at each level of the intervention to assess intervention effectiveness via both process and impact measures .
CONCLUSIONS	This project is novel in multiple ways , including : the inclusion of stakeholders at multiple levels ( policy , institutional , and at multiple levels of the food system ) ; that it uses novel computational modeling methodologies to engage policy makers and guide informed decisions of intervention effectiveness ; it emphasizes both the built environment ( intervening with food sources ) and the social environment ( intervening with families and peers ) .
CONCLUSIONS	The design of the intervention and the evaluation plan of the BHCK project are documented here .
BACKGROUND	NCT02181010 ( July 2 , 2014 ) .

###24268031
BACKGROUND	The open Burch colposuspension , first described in 1961 had been widely employed for the surgical treatment of women with stress urinary incontinence ( SUI ) caused by urethral hypermobility .
BACKGROUND	We evaluated the long-term efficacy of laparoscopic Burch colposuspension ( LBC ) for SUI in women .
METHODS	A randomized prospective trial was conducted from September 2010 to January 2013 .
METHODS	The extraperitoneal laparoscopic Burch colposuspension was performed by an operator on 96 women , mean age was 54,3 3,7 years all of whom suffered from SUI or mixed urinary incontinence .
METHODS	Patients completed a self-administered the Short Form-36 ( SF-36 ) , the Physical Component Summary ( PCS ) and Mental Component Summary ( MCS ) , the Short Urinary Distress Inventory ( SUDI ) and Short Incontinence Impact Questionnaire ( SIIQ ) .
METHODS	at both baseline and follow up ( 6 weeks , 6 months , 18 months postoperatively ) .
METHODS	The Genito-Urinary Treatment Satisfaction Scale ( GUTSS ) was used to assess satisfaction with surgery .
RESULTS	After follow up was recorded an improvement of questionnaries scores .
RESULTS	The general health score is improved after surgery ( 2,60 1.02 versus 2,76 1.06 ) with p = 0.09 .
RESULTS	The PCS baseline score is 46.29 10.95 versus 49.54 10.41 after treatment with p = 0.01 , so there was a significant baseline to follow up improvement .
RESULTS	The MCS improved also , infact baseline score is 42.19 12.57 versus 42.70 13.03 with p = 0.87 .
RESULTS	The SUDI baseline score is 50.22 20.73 versus 23.92 17.90 , while SIIQ score is 49.98 23.90 versus 31.40 23.83 with p < 0.01 .
RESULTS	In both questionnaires there is an improvement .
RESULTS	Satisfaction with treatment outcomes from the GUTSS at 6-month follow up is 29.5 6.3 with p = 0.46 .
CONCLUSIONS	The LBC has significant advantages , without any apparent compromise in short-term and long term outcomes .

###24880778
OBJECTIVE	The purpose of this study was to compare the effects of thoracic thrust manipulation vs thoracic non-thrust mobilization in patients with bilateral chronic mechanical neck pain on pressure pain sensitivity and neck pain intensity .
METHODS	Fifty-two patients ( 58 % were female ) were randomly assigned to a thoracic spine thrust manipulation group or of thoracic non-thrust mobilization group .
METHODS	Pressure pain thresholds ( PPTs ) over C5-C6 zygapophyseal joint , second metacarpal , and tibialis anterior muscle and neck pain intensity ( 11-point Numerical Pain Rate Scale ) were collected at baseline and 10 minutes after the intervention by an assessor blinded to group allocation .
METHODS	Mixed-model analyses of variance ( ANOVAs ) were used to examine the effects of the treatment on each outcome .
METHODS	The primary analysis was the group * time interaction .
RESULTS	No significant interactions were found with the mixed-model ANOVAs for any PPT ( C5-C6 : P > .252 ; second metacarpal : P > .452 ; tibialis anterior : P > .273 ) : both groups exhibited similar increases in PPT ( all , P < .01 ) , but within-group and between-group effect sizes were small ( standardized mean score difference [ SMD ] < 0.22 ) .
RESULTS	The ANOVA found that patients receiving thoracic spine thrust manipulation experienced a greater decrease in neck pain ( between-group mean difference : 1.4 ; 95 % confidence interval , 0.8-2 .1 ) than did those receiving thoracic spine non-thrust mobilization ( P < .001 ) .
RESULTS	Within-group effect sizes were large for both groups ( SMD > 2.1 ) , and between-group effect size was also large ( SMD = 1.3 ) in favor of the manipulative group .
CONCLUSIONS	The results of this randomized clinical trial suggest that thoracic thrust manipulation and non-thrust mobilization induce similar changes in widespread PPT in individuals with mechanical neck pain ; however , the changes were clinically small .
CONCLUSIONS	We also found that thoracic thrust manipulation was more effective than thoracic non-thrust mobilization for decreasing intensity of neck pain for patients with bilateral chronic mechanical neck pain .

###24617494
OBJECTIVE	To determine whether a single session of motivational interviewing ( MI ) for feedback of a child 's overweight status promotes engagement in treatment following screening .
METHODS	One thousand ninety-three children aged 4-8 years were recruited through primary and secondary care to attend health screening , including assessment of parenting practices and motivation ( questionnaire ) .
METHODS	Families with normal-weight children were informed about their child 's weight but had no further involvement .
METHODS	Parents of overweight ( body mass index 85th percentile ) children ( n = 271 ) were randomised to receive weight feedback via MI or best practice care ( BPC ) using a traffic light concept to indicate degree of health risk .
METHODS	Follow-up interviews were held 2 weeks later to examine intervention uptake , changes to motivation and behaviour , and parental response to feedback .
RESULTS	Recruitment into the intervention was high ( 76 % ) and not altered by feedback condition ( percentage difference 6.6 ( 95 % confidence interval -2.9 , 16.0 ) .
RESULTS	High scores on the Health Care Climate Questionnaire ( rating of the interviewer ) indicated satisfaction with how the information was provided to parents .
RESULTS	No differences were observed in multiple indicators of harm .
RESULTS	However , self-determined motivation for healthy life-styles was significantly higher in the MI condition at follow-up ( 0.18 : 0.00 , 0.35 ) , after only a single session of MI .
CONCLUSIONS	MI and BPC were both successful in encouraging parents to participate in a family-based intervention , with MI offering little significant benefit over BPC .
CONCLUSIONS	A traffic light approach to weight feedback is a suitable way of providing sensitive information to parents not expecting such news .

###24929431
OBJECTIVE	The most common form of maturity-onset diabetes of the young ( MODY ) , hepatocyte nuclear factor 1 ( HNF1A diabetes : MODY3 ) is often treated with sulfonylureas that confer a high risk of hypoglycemia .
OBJECTIVE	We evaluated treatment with GLP-1 receptor agonists ( GLP-1RAs ) in patients with HNF1A diabetes .
METHODS	Sixteen patients with HNF1A diabetes ( 8 women ; mean age 39 years [ range 23-67 years ] ; BMI 24.9 0.5 kg/m ( 2 ) [ mean SEM ] ; fasting plasma glucose [ FPG ] 9.9 0.9 mmol/L ; HbA1c 6.4 0.2 % [ 47 3 mmol/mol ] ) received 6 weeks of treatment with a GLP-1RA ( liraglutide ) and placebo ( tablets ) , as well as a sulfonylurea ( glimepiride ) and placebo ( injections ) , in randomized order , in a double-blind , crossover trial .
METHODS	Glimepiride was up-titrated once weekly in a treat-to-target manner ; liraglutide was up-titrated once weekly to 1.8 mg once daily .
METHODS	At baseline and at the end of each treatment period a standardized liquid meal test was performed , including a 30-min light bicycle test .
RESULTS	FPG decreased during the treatment periods ( -1.6 0.5 mmol/L liraglutide [ P = 0.012 ] and -2.8 0.7 mmol/L glimepiride [ P = 0.003 ] ) , with no difference between treatments ( P = 0.624 ) .
RESULTS	Postprandial plasma glucose ( PG ) responses ( total area under the curve ) were lower with both glimepiride ( 2,136 292 min mmol/L ) and liraglutide ( 2,624 340 min mmol/L ) compared with baseline ( 3,127 291 min mmol/L ; P < 0.001 , glimepiride ; P = 0.017 , liraglutide ) , with no difference between treatments ( P = 0.121 ) .
RESULTS	Eighteen episodes of hypoglycemia ( PG 3.9 mmol/L ) occurred during glimepiride treatment and one during liraglutide treatment .
CONCLUSIONS	Six weeks of treatment with glimepiride or liraglutide lowered FPG and postprandial glucose excursions in patients with HNF1A diabetes .
CONCLUSIONS	The glucose-lowering effect was greater with glimepiride at the expense of a higher risk of exclusively mild hypoglycemia .

###25670366
OBJECTIVE	Our aim was to assess the effects of the cholesteryl ester transfer protein ( CETP ) inhibitor anacetrapib and atorvastatin , both as monotherapy and in combination , on particle concentrations of low-density lipoproteins ( LDL ) , very low-density lipoproteins ( VLDL ) , and intermediate-density lipoproteins in dyslipidemic patients .
BACKGROUND	Although increases in high-density lipoproteins with CETP inhibition are well-documented , effects on atherogenic lipoprotein particle subclasses in dyslipidemic patients have not been extensively characterized .
METHODS	Ion mobility was performed on stored plasma samples collected from patients before and after treatment with anacetrapib alone ( 150 and 300 mg/d ) or in combination with atorvastatin ( 20 mg/d ) in a previously conducted 8-week phase IIb study .
RESULTS	Anacetrapib produced significant placebo-adjusted reductions of total LDL particles and all subfractions except for increases in very small LDL 4a and 4b .
RESULTS	Atorvastatin reduced all LDL subfractions except LDL 4b .
RESULTS	Results were generally additive for anacetrapib + atorvastatin .
RESULTS	For patients treated with anacetrapib , the placebo-adjusted reduction in LDL 3a was attenuated and there was an increase in LDL 3b and 4a for those with low vs high triglyceride ( TG ) levels .
RESULTS	For the atorvastatin alone vs placebo treatment comparison , there were small reductions in LDL 3a , 3b , and 4a for those with low vs high TG levels .
CONCLUSIONS	Anacetrapib and atorvastatin produced similar reductions from baseline in total LDL particles , but did not have comparable effects on all LDL particle subfractions , and neither drug reduced the smallest LDL 4b particles .
CONCLUSIONS	The clinical significance of these changes and the differential effects on very small LDL 4a in patients with higher vs lower TG remain to be determined ( clinicaltrials.gov , NCT00325455 ) .

###24965823
BACKGROUND	Rituximab could be an effective treatment for childhood-onset , complicated , frequently relapsing nephrotic syndrome ( FRNS ) and steroid-dependent nephrotic syndrome ( SDNS ) .
BACKGROUND	We investigated the efficacy and safety of rituximab in patients with high disease activity .
METHODS	We did a multicentre , double-blind , randomised , placebo-controlled trial at nine centres in Japan .
METHODS	We screened patients aged 2 years or older experiencing a relapse of FRNS or SDNS , which had originally been diagnosed as nephrotic syndrome when aged 1-18 years .
METHODS	Patients with complicated FRNS or SDNS who met all other criteria were eligible for inclusion after remission of the relapse at screening .
METHODS	We used a computer-generated sequence to randomly assign patients ( 1:1 ) to receive rituximab ( 375 mg/m ( 2 ) ) or placebo once weekly for 4 weeks , with age , institution , treatment history , and the intervals between the previous three relapses as adjustment factors .
METHODS	Patients , guardians , caregivers , physicians , and individuals assessing outcomes were masked to assignments .
METHODS	All patients received standard steroid treatment for the relapse at screening and stopped taking immunosuppressive agents by 169 days after randomisation .
METHODS	Patients were followed up for 1 year .
METHODS	The primary endpoint was the relapse-free period .
METHODS	Safety endpoints were frequency and severity of adverse events .
METHODS	Patients who received their assigned intervention were included in analyses .
METHODS	This trial is registered with the University Hospital Medical Information Network clinical trials registry , number UMIN000001405 .
RESULTS	Patients were centrally registered between Nov 13 , 2008 , and May 19 , 2010 .
RESULTS	Of 52 patients who underwent randomisation , 48 received the assigned intervention ( 24 were given rituximab and 24 placebo ) .
RESULTS	The median relapse-free period was significantly longer in the rituximab group ( 267 days , 95 % CI 223-374 ) than in the placebo group ( 101 days , 70-155 ; hazard ratio : 027 , 014-053 ; p < 00001 ) .
RESULTS	Ten patients ( 42 % ) in the rituximab group and six ( 25 % ) in the placebo group had at least one serious adverse event ( p = 036 ) .
CONCLUSIONS	Rituximab is an effective and safe treatment for childhood-onset , complicated FRNS and SDNS .
BACKGROUND	Japanese Ministry of Health , Labour and Welfare .

###24501378
BACKGROUND	Increased physical activity is associated with decreased risk of several types of cancer , but underlying mechanisms are poorly understood .
BACKGROUND	Angiogenesis , in which new blood vessels are formed , is common to adipose tissue formation/remodeling and tumor vascularization .
METHODS	We examined effects of a 12-month 45 minutes/day , 5 days/week moderate-intensity aerobic exercise intervention on four serum markers of angiogenesis in 173 sedentary , overweight , postmenopausal women , 50 to 75 years , randomized to intervention versus stretching control .
METHODS	Circulating levels of positive regulators of angiogenesis [ VEGF , osteopontin ( OPN ) , plasminogen activator inhibitor-1 ( PAI-1 ) ] , and the negative regulator pigment epithelium-derived factor ( PEDF ) , were measured by immunoassay at baseline and 12 months .
METHODS	Changes were compared using generalized estimating equations , adjusting for baseline levels of analytes and body mass index ( BMI ) .
RESULTS	VEGF , OPN , or PAI-1 levels did not differ by intervention arm .
RESULTS	Participants randomized to exercise significantly reduced PEDF ( -3.7 % ) versus controls ( +3.0 % ; P = 0.009 ) .
RESULTS	Reductions in fat mass were significantly associated with reductions in PAI-1 ( Ptrend = 0.03 ; Ptrend = 0.02 ) and PEDF ( Ptrend = 0.002 ; Ptrend = 0.01 ) compared with controls , or to those who gained any fat mass respectively .
RESULTS	There was a significant association between decreases in VO2max , and increased reductions in PEDF ( Ptrend = 0.03 ) , compared with participants who increased their level of fitness .
CONCLUSIONS	Fat loss reduces circulating PAI-1 and PEDF .
CONCLUSIONS	Changes in VO2max are associated with alterations in PEDF , but these associations are complex .
CONCLUSIONS	Unexpected reductions in PEDF with decreasing fat mass , and with decreasing VO2max , warrant further study , including examining the effects of different types and intensities of exercise ; and role of dietary weight-loss with and without exercise .

###25294786
BACKGROUND	Growth differentiation factor 15 ( GDF-15 ) , high-sensitivity troponin , and N-terminal pro-brain natriuretic peptide levels are predictive of death and cardiovascular events in healthy elderly subjects , patients with acute coronary syndrome , and patients with heart failure .
BACKGROUND	High-sensitivity troponin I and N-terminal pro-brain natriuretic peptide are also prognostic in patients with atrial fibrillation .
BACKGROUND	We evaluated the prognostic value of GDF-15 alone and in addition to clinical characteristics and other biomarkers in patients with atrial fibrillation .
RESULTS	The Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation ( ARISTOTLE ) trial randomized 18201 patients with atrial fibrillation to apixaban or warfarin .
RESULTS	Biomarkers were measured at randomization in 14798 patients .
RESULTS	Efficacy and safety outcomes during 1.9 years of follow-up were compared across quartiles of GDF-15 by use of Cox analyses adjusted for clinical characteristics , randomized treatment , and other biomarkers .
RESULTS	The GDF-15 level showed a median of 1383 ng/L ( interquartile range , 977-2052 ng/L ) .
RESULTS	Annual rates of stroke or systemic embolism ranged from 0.9 % to 2.03 % ( P < 0.001 ) ; of major bleeding , from 1.22 % to 4.53 % ( P < 0.001 ) ; and of mortality , from 1.34 % to 7.19 % ( P < 0.001 ) in the lowest compared with the highest GDF-15 quartile .
RESULTS	The prognostic information provided by GDF-15 was independent of clinical characteristics and clinical risk scores .
RESULTS	Adjustment for the other cardiac biomarkers attenuated the prognostic value for stroke , whereas the prognostic value for mortality and major bleeding remained .
RESULTS	Apixaban consistently reduced stroke , mortality , and bleeding , regardless of GDF-15 levels .
CONCLUSIONS	GDF-15 is a risk factor for major bleeding , mortality , and stroke in atrial fibrillation .
CONCLUSIONS	The prognostic value for major bleeding and death remained even in the presence of N-terminal pro-brain natriuretic peptide and high-sensitivity troponin I.
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00412984 .

###25252515
OBJECTIVE	To assess the effectiveness of behavioural management in the treatment of migraine among adult patients .
METHODS	The randomised control trial was conducted from August 2011 to August 2012 at the Aga Khan University Hospital , Karachi , in which adult patients aged 18-65 years were recruited with diagnosis of migraine from five outpatient sites .
METHODS	The patients were randomised into 2 equal groups .
METHODS	The controls were given pharmacological treatment , while the cases were given a structured behavioural management and pharmacological treatment .
METHODS	Primary outcome was the change in frequency of migraine attacks .
METHODS	Secondary outcome included change in severity of migraine and effect on the quality of life .
METHODS	SPSS 19 was used for statistical analysis .
RESULTS	Of the 90 subjects in the study , 72 ( 80 % ) were female .
RESULTS	A significant reduction in the average frequency of migraine attacks was observed from baseline up to 4 weeks ( p < 0.001 ) but no difference in the mean migraine attacks was observed in the two groups ( p < 0.945 ) .
RESULTS	In the average score of severity of pain , significant reduction was observed for time ( p < 0.001 ) as well as for the intervention status ( p < 0.034 ) .
RESULTS	There was no significant difference ( p < 0.450 ) between treatment type and duration of migraine , but a significantly better quality of life ( p < 0.001 ) was observed in the trial group compared to the controls .
CONCLUSIONS	There was significant decrease in frequency , severity and duration of migraine attacks in the trial group compared to the control group .
CONCLUSIONS	The quality of life also showed improvement in the trial group .

###25363124
OBJECTIVE	Physical activity is one of the core components in cardiac rehabilitation and secondary prevention programs .
OBJECTIVE	This study investigated the effect of an intervention based on the health action process approach ( HAPA ) together with family support in the maintenance of physical activity and exercise capacity in coronary heart disease after discharge from rehabilitation .
METHODS	In this randomized controlled trial , 96 patients with coronary heart disease were randomly assigned to control and intervention groups at the end of a rehabilitation program at Afshar Hospital , Yazd , Iran .
METHODS	HAPA Constructs and family support using a self-reported questionnaire and maximal oxygen uptake through a treadmill exercise test were measured prior to and 4 months after the intervention .
RESULTS	HAPA-based intervention together with family support increased scores of HAPA constructs and family support in the intervention group compared with the control group .
RESULTS	The results showed that physical activity and exercise capacity in the intervention group was significantly higher than the control group after the intervention .
CONCLUSIONS	HAPA-based intervention together with family support can be a useful tool for maintenance of physical activity and exercise capacity in coronary heart disease .

###24615215
OBJECTIVE	To observe the physiological and psychological effects of Chinese traditional healthcare exercises ( CTHE ) on the adolescents .
METHODS	A total of 136 healthy students of junior school were recruited and randomly divided into the test group ( 68 cases ) and the control group ( 68 cases ) .
METHODS	The subjects in the test group practiced CTHE , while those in the control group did `` the 8th radio calisthenics '' , an official recommended calisthenics for promoting healthcare in China , 3 times a week , and 7 weeks practicing overall .
METHODS	The general body function examination and the meridian energy detection system were used to determine the effects of the two groups .
RESULTS	( 1 ) After exercise , the chest circumference and heart rate were increased significantly ( P < 0.01 ) , and both the systolic pressure ( SP ) and diastolic pressure ( DP ) were decreased significantly ( P < 0.01 ) , while the weight had no significant change ( P > 0.05 ) in the test group .
RESULTS	In the control group , the chest circumference , the SP and DP had no significant improvement ( P > 0.05 ) , while the heart rate was significantly increased and the weight was significantly decreased ( P < 0.01 ) .
RESULTS	( 2 ) The test group achieved significant positive changes in the performance status , state of mind and fatigue index ( P < 0.01 or P < 0.05 ) , while the control group only achieved a significant positive change in performance status ( P < 0.01 ) , and a negative significant decrease in the autonomic nerve function ( P < 0.05 ) .
CONCLUSIONS	Junior school students would get physiological and psychological benefit from practicing CTHE , and which is suitable for them to practice .

###25563642
OBJECTIVE	The relationships between cerebrovascular lesions visible on imaging and cognition are complex .
OBJECTIVE	We explored the possibility that the cerebral cortical volume mediated these relationships .
METHODS	Total of 1906 nondemented participants ( 59 % women ; 25 % African-American ; mean age , 76.6 years ) in the Atherosclerosis Risk in Communities ( ARIC ) study underwent cognitive assessments , risk factor assessments , and quantitative MRI for white matter hyperintensities ( WMH ) and infarcts .
METHODS	The Freesurfer imaging analysis pipeline was used to determine regional cerebral volumes .
METHODS	We examined the associations of cognitive domain outcomes with cerebral volumes ( hippocampus and separate groups of posterior and frontal cortical regions of interest ) and cerebrovascular imaging features ( presence of large or small cortical/subcortical infarcts and WMH volume ) .
METHODS	We performed mediation pathway analyses to assess the hypothesis that hippocampal and cortical volumes mediated the associations between cerebrovascular imaging features and cognition .
RESULTS	In unmediated analyses , WMH and infarcts were both associated with worse psychomotor speed/executive function .
RESULTS	In mediation analyses , WMH and infarct associations on psychomotor speed/executive function were significantly attenuated , but not abolished , by the inclusion of the posterior cortical regions of interest volume in the models , and the infarcts on psychomotor speed/executive function association were attenuated , but not abolished , by inclusion of the frontal cortical regions of interest volume .
CONCLUSIONS	Both WMH and infarcts were associated with cortical volume , and both lesions were also associated with cognitive performance , implying shared pathophysiological mechanisms .
CONCLUSIONS	Although cross-sectional , our findings suggest that WMH and infarcts could be proxies for clinically covert processes that directly damage cortical regions .
CONCLUSIONS	Microinfarcts are 1 candidate for such a clinically covert process .

###24821476
OBJECTIVE	Although white matter hyperintensities ( WMHs ) are associated with the risk for Alzheimer disease , it is unknown whether they represent an independent source of impairment or interact with known markers of disease .
OBJECTIVE	To examine the degree to which WMHs predict aggressive cognitive decline among individuals with mild cognitive impairment , either independently or by modifying the effects of entorhinal cortex volume ( ECV ) , a marker of Alzheimer disease-related neurodegeneration .
METHODS	The Alzheimer 's Disease Neuroimaging Initiative is a longitudinal study with 6-month follow-up visits .
METHODS	Three hundred thirty-two participants ( mean [ SD ] age , 74.6 [ 7.4 ] years ; 118 women ) of a total of 374 participants diagnosed as having mild cognitive impairment were included .
METHODS	Participants were excluded if they did not have longitudinal data , apolipoprotein E genotype data , or had evidence of supratentorial infarct .
METHODS	A decline in Mini-Mental State Examination score of 3 points over 6 months or 6 points over 1 year between consecutive visits was defined as aggressive decline .
METHODS	White matter hyperintensity volume and ECV were entered as predictors in Cox proportional hazards models and Wilcoxon-Breslow tests to examine their impact on this outcome , adjusting for sex , age , education , and apolipoprotein E status .
RESULTS	Greater WMH volume at baseline , apolipoprotein E 4 status , and smaller ECV at baseline were associated with an increased risk for aggressive decline ( hazard ratio [ HR ] , 1.23 ; 95 % CI , 1.05-1 .43 ; P = .01 for WMH volume ; HR , 1.49 ; 95 % CI , 1.09-2 .05 ; P = .04 for apolipoprotein E 4 status ; HR , 0.66 ; 95 % CI , 0.55-0 .79 ; P < .001 for ECV ) .
RESULTS	White matter hyperintensity volume modified the effect of ECV on aggressive decline risk : individuals with high ECV and low WMH were at particularly low likelihood of decline ( 2 = 15 , P = .001 ) .
RESULTS	Participants with Mini-Mental State Examination scores that declined by 3 or more points over 6 months or 6 or more points over 12 months were more likely to have converted to Alzheimer disease by the end of the follow-up period ( 2 = 82 , P < .001 ) .
CONCLUSIONS	White matter hyperintensity burden and ECV predict rapid cognitive decline among individuals with mild cognitive impairment both additively and multiplicatively .

###25315126
BACKGROUND	There is a need for an adjuvant agent of caudal block that prolongs its duration and improves the analgesic efficacy to fasten functional recovery .
BACKGROUND	Magnesium is an N-methyl-D-aspartate receptor antagonist that functions as an analgesic .
BACKGROUND	This study was aimed to evaluate whether magnesium as an adjuvant for caudal block in children can improve postoperative analgesia and functional recovery .
METHODS	Eighty children , 2-6 years of age , undergoing inguinal herniorrhaphy , were included in this prospective , randomized , double-blinded study .
METHODS	For caudal block , Group R received ropivacaine 1.5 mgml ( -1 ) , 1 mlkg ( -1 ) and Group RM received the same dose of ropivacaine mixed with 50 mg of magnesium .
METHODS	The Parents ' Postoperative Pain Measure ( PPPM ) score , analgesic consumption , functional recovery , and adverse effects were evaluated at 6 , 24 , 48 , and 72 h after surgery , as well as daily thereafter until the child showed full functional recovery .
RESULTS	The PPPM score after hospital discharge was significantly lower for Group RM than for Group R at all times ( P < 0.05 ) .
RESULTS	Children in Group RM required less fentanyl for rescue analgesia in the recovery area ( 16.2 % vs 39.5 % , P = 0.034 ) and less oral analgesics after discharge ( 20.5 % vs 52.6 % , P = 0.007 ) .
RESULTS	The time to return of normal functional activity was shorter in Group RM ( P < 0.05 ) .
RESULTS	The incidence of adverse effects did not differ between groups .
CONCLUSIONS	As an adjuvant for caudal analgesia , 50 mg magnesium provided superior quality of analgesia and faster return of normal functional activity than local anesthetic alone in children .

###24529697
BACKGROUND	Cytology is a widely used method of triaging women who test positive for human papillomavirus ( HPV ) .
BACKGROUND	However , self-sampled specimens , which can substantially increase participation in screening programmes , are not suitable for accurate cytological assessment .
BACKGROUND	We investigated whether direct DNA methylation-based molecular triage on self-sampled cervicovaginal specimens was non-inferior to cytology triage on additional physician-collected cervical samples in the detection of cervical intraepithelial neoplasia grade 2 ( CIN2 ) or worse in women who did not attend cervical screening programmes .
METHODS	In this randomised controlled non-inferiority trial , we invited women ( aged 33-63 years ) registered as non-attendees of cervical screening in the Netherlands in 2007 to submit a self-collected cervicovaginal sample for HPV testing .
METHODS	Using a computer-generated sequence , we randomly allocated women who tested positive for high-risk hrHPV on a self-sample to either triage by cytology on an additional physician-taken smear or direct triage on the self-sample by methylation analysis of MAL and miR-124-2 genes ( 1:1 ; stratified by age and region , with block sizes by age group ) .
METHODS	Triage-positive women in either group were referred for colposcopy .
METHODS	The primary endpoint was detection of CIN2 or worse , analysed by intention to treat .
METHODS	The non-inferiority margin was 080 .
METHODS	This study is registered in the Primary Trial Register of the Netherlands , number NTR6026 .
RESULTS	We invited 46,001 women to participate , 12,819 of whom returned self-sampled material ; 1038 samples tested positive for high-risk HPV .
RESULTS	Between Nov 1 , 2010 , and Dec 31 , 2011 , after exclusion of women who were ineligible , we enrolled and randomly allocated 515 women to methylation triage and 509 to cytology triage .
RESULTS	The detection of CIN2 or worse with methylation triage was non-inferior to that with cytology triage ( 90 [ 17 % ] of 515 women vs 75 [ 15 % ] of 509 women ; relative risk 119 , 95 % CI 090-157 ) .
RESULTS	Referral for colposcopy was more common in the molecular group ( 284 [ 55 % ] women ) than in the cytology group ( 149 [ 29 % ] women ; p < 00001 ) .
RESULTS	Mean time to CIN2 or worse diagnosis was shorter in the molecular triage group ( 96 days , range 44-101 ) than in the cytology triage group ( 158 days , 71-222 ; p = 000084 ) .
CONCLUSIONS	DNA methylation analysis of MAL and miR-124-2 genes on HPV-test-positive self-samples is non-inferior to cytology triage in the detection of CIN2 or worse , opening the way to full molecular screening .
BACKGROUND	Midden-West and Oost Screening Organisations and Stichting Achmea Gezondheidszorg .

###24693627
OBJECTIVE	To evaluate the effect of artificial demineralization upon color change of dentin in contact with dental amalgam .
METHODS	Sound human molars ( n = 34 ) were embedded in resin and coronal enamel was removed .
METHODS	Dentin was exposed to artificial caries gel ( pH 5.5 ) at 37 degrees C for 12 weeks ( n = 24 ) .
METHODS	Non-demineralized teeth served as controls ( n = the 10 ) .
METHODS	A dispersive high-Cu amalgam or conventional low-Cu amalgam was condensed onto dentin surfaces of all groups .
METHODS	After 10 weeks storage in saline , amalgam was removed and teeth were cut into three slices .
METHODS	Surfaces were inspected under optical microscopy and photographed .
RESULTS	Penetration of black pigments was observed in dentin underneath both high-Cu and low-Cu amalgams in demineralized specimens .
RESULTS	Black deposits were unevenly distributed and observed predominantly in dentin near to pulp horns .
RESULTS	Discoloration was not limited to outer demineralized dentin but extended beyond this zone .
RESULTS	Evenly distributed bluish-green discoloration was observed underneath all high-Cu amalgam specimens independent of demineralization .

###24535604
BACKGROUND	Evaluation of analgesia and antinociception during anaesthesia is still a challenging issue and routinely based on indirect and non-specific signs such as movement , tachycardia , or lacrimation .
BACKGROUND	Recently , the surgical pleth index ( SPI ) derived by finger plethysmography was introduced to detect nociceptive stimulation during anaesthesia .
BACKGROUND	While SPI guidance reduced the number of unwanted events during total i.v. anaesthesia ( TIVA ) , the impact of SPI during volatile-based anaesthesia with intermittent opioid administration has not yet been elucidated .
METHODS	Ninety-four patients were randomized into either SPI-guided analgesia or standard practice ( Control ) .
METHODS	In both groups , anaesthesia was maintained with sevoflurane to keep bispectral index values between 40 and 60 .
METHODS	In the SPI group , patients received a sufentanil bolus ( 10 g ) whenever SPI value increased above 50 , whereas in the control group , sufentanil was administered according to standard clinical practice .
METHODS	The number of unwanted somatic events , haemodynamics , sufentanil consumption , and recovery times were recorded .
RESULTS	The incidence of intraoperative unwanted somatic events was comparable between the groups ( P = 0.89 ) .
RESULTS	No significant differences with respect to hypotensive or hypertensive events were found .
RESULTS	The mean ( 95 % confidence interval ) sufentanil consumption was non-significantly ( P = 0.07 ) reduced in the SPI group , 0.64 ( 0.57-0 .71 ) vs 0.78 ( 0.64-0 .91 ) g min ( -1 ) .
RESULTS	Recovery times were comparable between the groups .
CONCLUSIONS	Sufentanil administration guided by SPI during sevoflurane anaesthesia is clinically feasible .
CONCLUSIONS	In contrast to TIVA , it did not improve anaesthesia conduct with respect to unwanted somatic events , haemodynamic stability , sufentanil consumption , emergence time , or post-anaesthesia care unit care .
CONCLUSIONS	Therefore , we conclude that anaesthesia regimen has an impact on beneficial effects by SPI guidance .
CONCLUSIONS	Clinical trial registration NCT01525537 .
CONCLUSIONS	( Registered at Clinicaltrials.gov . )

###24273218
METHODS	Equol is produced by the intestinal bacteria from isoflavone daidzein .
METHODS	Studies have reported the health benefits of soy can only present or more pronounced in equol producers .
METHODS	This 6-month randomized controlled trial examined the effect of whole soy ( soy flour ) and purified daidzein on cardiovascular biomarkers and carotid intima-media thickness ( CIMT ) in prehypertensive postmenopausal women who were equol producers .
RESULTS	Two hundred seventy eligible women were randomized to either one of the three treatments : 40 g soy flour ( whole soy group ) , 40 g low-fat milk powder + 63mg daidzein ( daidzein group ) , or 40 g low-fat milk powder ( placebo group ) daily each for 6 months .
RESULTS	Fasting venous samples were obtained at baseline and end of trial for testing glucose , lipids , high sensitivity C-reactive protein ( hs-CRP ) , and free fatty acid .
RESULTS	Changes in common CIMT were also assessed .
RESULTS	Serum LDL-C decreased by 7.95 % ( 95 % CI : -15.09 -0.81 % ) and 6.32 % ( 95 % CI : -13.450.08 % ) , and serum hs-CRP decreased by 0.164 ( 95 % CI : -0.309 -0.019 ) and 0.054 ( 95 % CI : -0.1990.012 ) in the whole soy group compared with daidzein and milk placebo groups , respectively .
RESULTS	No significant change in CIMT was found .
CONCLUSIONS	Whole soy , but not purified daidzein , had a beneficial effect on reduction of LDL-C and hs-CRP among prehypertensive equol-producing postmenopausal women .

###24667664
OBJECTIVE	To investigate the effectiveness of an intensive nursing care electronic followup system for cardiovascular risk management after percutaneous coronary intervention ( PCI ) .
METHODS	In total , 840 subjects who underwent PCI in a single hospital in Beijing between January 2010 and January 2012 were enrolled .
METHODS	All subjects were randomized into the control and intensive nursing care groups ( n = 420 each group ) .
METHODS	Both groups received standard secondary prevention according to guidelines .
METHODS	The control group received regular followup while the intensive nursing care group was closely monitored and followed by specific nursing staff with the electronic followup system .
RESULTS	In total , 807 subjects were followed up for 1 year .
RESULTS	Compared with subjects in the control group , those in the intensive group had decreased levels of total cholesterol ( 3.99 1.08 vs 3.76 0.98 ; P < .05 ) , systolic blood pressure ( 142.41 11.53 vs 135.71 14.57 mm Hg ; P < .05 ) , low-density lipoprotein cholesterol ( LDL-C ) ( 2.72 1.01 vs 2.42 0.81 ; P < .05 ) , and body mass index ( 25.13 5.12 vs 24.23 6.22 ; P < .05 ) ; a higher percentage with target LDL-C < 2.6 mmol/L ( 66.99 % vs 47.88 % ; P < .05 ) ; increased use of medication including aspirin ( 96.51 % vs 99.26 % ; P < .05 ) , clopidogrel ( 87.53 % vs 98.77 % ; P < .05 ) , statins ( 52.62 % vs 93.10 % ; P < .05 ) , - blockers ( 48.63 % vs 61.33 % ; P < .05 ) , and angiotensin-converting enzyme inhibitors ( 32.92 % vs 61.82 % ; P < .05 ) ; and better dietary control and physical exercise ( 55.66 % vs 26.18 % , P < .05 ; 62.56 % vs 38.65 % , P < .05 ) .
CONCLUSIONS	Intensive nursing care by the electronic followup system may lead to an improvement in quality of secondary prevention after PCI , including risk factor control , the use of medication , and self-management abilities .

###24562087
OBJECTIVE	This study evaluates the efficacy of integrating PTSD treatment into Dialectical Behavior Therapy ( DBT ) for women with borderline personality disorder , PTSD , and intentional self-injury .
METHODS	Participants were randomized to DBT ( n = 9 ) or DBT with the DBT Prolonged Exposure ( DBT PE ) protocol ( n = 17 ) and assessed at 4-month intervals during the treatment year and 3-months post-treatment .
RESULTS	Treatment expectancies , satisfaction , and completion did not differ by condition .
RESULTS	In DBT+DBT PE , the DBT PE protocol was feasible to implement for a majority of treatment completers .
RESULTS	Compared to DBT , DBT+DBT PE led to larger and more stable improvements in PTSD and doubled the remission rate among treatment completers ( 80 % vs. 40 % ) .
RESULTS	Patients who completed the DBT PE protocol were 2.4 times less likely to attempt suicide and 1.5 times less likely to self-injure than those in DBT .
RESULTS	Among treatment completers , moderate to large effect sizes favored DBT+DBT PE for dissociation , trauma-related guilt cognitions , shame , anxiety , depression , and global functioning .
CONCLUSIONS	DBT with the DBT PE protocol is feasible , acceptable , and safe to administer , and may lead to larger improvements in PTSD , intentional self-injury , and other outcomes than DBT alone .
CONCLUSIONS	The findings require replication in a larger sample .

###24476418
BACKGROUND	Recent studies of inhaled tobramycin in subjects with cystic fibrosis ( CF ) find less clinical improvement than previously observed .
BACKGROUND	Nonhuman data suggest that in some strains of Pseudomonas aeruginosa , azithromycin can antagonize tobramycin .
OBJECTIVE	We tested the hypothesis that concomitant azithromycin use correlates with less improvement in key outcome measures in subjects receiving inhaled tobramycin while not affecting those receiving a comparative , nonaminoglycoside inhaled antibiotic .
METHODS	We studied a cohort of 263 subjects with CF enrolled in a recent clinical trial comparing inhaled tobramycin with aztreonam lysine .
METHODS	We performed a secondary analysis to examine key clinical and microbiologic outcomes based on concomitant , chronic azithromycin use at enrollment .
RESULTS	The cohort randomized to inhaled tobramycin and reporting azithromycin use showed a significant decrease in the percent predicted FEV1 after one and three courses of inhaled tobramycin when compared with those not reporting azithromycin use ( 28 d : -0.51 vs. 3.43 % , P < 0.01 ; 140 d : -1.87 vs. 6.07 % , P < 0.01 ) .
RESULTS	Combined azithromycin and inhaled tobramycin use was also associated with earlier need for additional antibiotics , lesser improvement in disease-related quality of life , and a trend toward less reduction in sputum P. aeruginosa density .
RESULTS	Subjects randomized to inhaled aztreonam lysine had significantly greater improvement in these outcome measures , which were unaffected by concomitant azithromycin use .
RESULTS	Outcomes in those not using azithromycin who received inhaled tobramycin were not significantly different from subjects receiving aztreonam lysine .
RESULTS	Azithromycin also antagonized tobramycin but not aztreonam lysine in 40 % of P. aeruginosa clinical isolates tested in vitro .
CONCLUSIONS	Oral azithromycin may antagonize the therapeutic benefits of inhaled tobramycin in subjects with CF with P. aeruginosa airway infection .

###24471907
OBJECTIVE	To evaluate the efficacy and safety of the 3-adrenoceptor agonist mirabegron , in a Japanese population with overactive bladder ( OAB ) .
METHODS	This randomised , double-blind , placebo-controlled phase III study enrolled adult patients experiencing OAB symptoms for 24 weeks .
METHODS	Patients with 8 micturitions/24h and 1 urgency episode/24h or 1 urgency incontinence episode/24h were randomised to once-daily placebo , mirabegron 50mg or tolterodine 4mg ( as an active comparator , without testing for non-inferiority of efficacy and safety ) for 12 weeks .
METHODS	The primary endpoint was the change in the mean number of micturitions/24h from baseline to final assessment .
METHODS	Secondary endpoints included micturition variables related to urgency and/or incontinence and quality-of-life domain scores on the King 's Health Questionnaire .
METHODS	Safety assessments included adverse events ( AEs ) , post-void residual urine volume , laboratory variables , vital signs and 12-lead electrocardiogram .
RESULTS	A total of 1139 patients were randomised to receive placebo ( n = 381 ) , mirabegron 50mg ( n = 380 ) or tolterodine 4mg ( n = 378 ) .
RESULTS	Demographic and baseline characteristics were similar among the treatment groups .
RESULTS	At final assessment , mirabegron was significantly superior to placebo in terms of mean [ sd ] change from baseline in number of micturitions/24h ( -1.67 [ 2.212 ] vs -0.86 [ 2.354 ] ; P < 0.001 ) and mean [ sd ] change from baseline in number of urgency episodes/24h ( -1.85 [ 2.555 ] vs -1.37 [ 3.191 ] ; P = 0.025 ) , incontinence episodes/24h ( -1.12 [ 1.475 ] vs -0.66 [ 1.861 ] ; P = 0.003 ) , urgency incontinence episodes/24h ( -1.01 [ 1.338 ] vs -0.60 [ 1.745 ] ; P = 0.008 ) , and volume voided/micturition ( 24.300 [ 35.4767 ] vs 9.715 [ 29.0864 ] mL ; P < 0.001 ) .
RESULTS	The incidence of AEs in the mirabegron group was similar to that in the placebo group .
RESULTS	Most AEs were mild and none were severe .
CONCLUSIONS	Mirabegron 50mg once daily is an effective treatment for OAB symptoms , with a low occurrence of side effects in a Japanese population .

###25480930
BACKGROUND	Acute hemorheological responses to different types of aerobic exercises have never been compared in a single study in healthy people .
OBJECTIVE	We aimed to compare acute effects of high intensity intermittent exercise ( HIIE ) and moderate intensity continuous exercise ( MICE ) on hemorheological parameters , in healthy young subjects .
METHODS	A total of 34 sedentary young adults ( 12 males , 22 females ) with a mean age of 20.0 2.1 years were randomly assigned to HIIE , MICE or non-exercise groups .
METHODS	MICE exercised at the power corresponding to 50 % of heart rate reserve ( HRR ) continuously for 25 min .
METHODS	HIIE exercised at the power corresponding to 100 % of HRR for 30 s followed by 30 s rest for 25 min .
METHODS	The non-exercise group rested .
METHODS	Blood samples were collected before and after exercise and studied for blood count , whole blood viscosity ( WBV ) , plasma viscosity ( PV ) and red blood cell ( RBC ) elongation at nine different shear stresses .
RESULTS	WBV , PV , RBC elongation of MICE and HIIE groups were not found to be statistically different from each other or from the non-exercise group .
RESULTS	Compared to the non-exercise group , there was a significant increase in white blood cell ( WBC ) and RBC counts in the MICE group .
CONCLUSIONS	Different types of aerobic exercises , namely MICE , HIIE are not different from each other in terms of hemorheological parameters immediately after exercise .

###24224787
OBJECTIVE	To determine the effectiveness of a peer-led self-management programme for people with schizophrenia in reducing psychotic symptom severity , hospital readmission and psychiatric consultation and in enhancing cognition , empowerment , functioning level , medication adherence , perceived recovery , quality of life and social support .
BACKGROUND	Several self-management programmes have been developed to empower patients with severe mental illness in achieving recovery .
BACKGROUND	Research suggests that peer-led self-management programmes have positive effects on patient recovery .
BACKGROUND	However , the existing evidence is inconclusive , due to a lack of credible evidence and long-term follow-up evaluations .
METHODS	A stratified randomized controlled trial will be conducted at six community mental health rehabilitation centres
METHODS	A sample of 242 adults with schizophrenia will be recruited .
METHODS	A peer-led self-management programme , comprising six 2-hour sessions , will be implemented in the intervention group and a standard rehabilitation programme in the control group .
METHODS	Outcomes will be measured at baseline , postintervention and at the 6 - and 12-month follow-ups .
METHODS	The measures will include cognition , empowerment , functioning level , medication adherence , perceived recovery , quality of life , social support , symptom severity , hospital readmission and psychiatric consultation .
METHODS	A mixed effects model will be used to analyse the results .
METHODS	Semi-structured interviews will be conducted to explore the peer-trainers ' and participants ' perspectives on the programme .
METHODS	Research Ethics Committee approval was obtained in December 2011 and funding was obtained in January 2012 .
CONCLUSIONS	This study will provide evidence on the effectiveness of a peer-led self-management programme for patient recovery .
CONCLUSIONS	It will identify a clinically useful and potentially effective intervention that incorporates empowerment concept .

###24522178
BACKGROUND	The optimum dose of key antiretroviral drugs is often overlooked during product development .
BACKGROUND	The ENCORE1 study compared the efficacy and safety of reduced dose efavirenz with standard dose efavirenz in combination with tenofovir and emtricitabine as first-line treatment for HIV infection .
BACKGROUND	An effective and safe reduced dose could yield meaningful cost savings .
METHODS	ENCORE1 is a continuing non-inferiority trial in HIV-1-infected antiretroviral-naive adults in 38 clinical sites in 13 countries .
METHODS	Participants ( plasma HIV-RNA > 1000 log10 copies per mL , CD4 T-cell count 50-500 cells per L ) were randomly assigned by a computer-generated sequence with a blocking factor of four ( stratified by clinical site and by screening viral load ) to receive tenofovir plus emtricitabine with either a reduced daily dose ( 400 mg ) or a standard dose ( 600 mg ) of efavirenz .
METHODS	Participants , physicians , and all other trial staff were masked to treatment group .
METHODS	The primary endpoint was the difference in proportions of participants with plasma HIV-RNA of less than 200 copies per mL at 48 weeks .
METHODS	Treatment groups were regarded as non-inferior if the lower limit of the 95 % CI for the difference in viral load was less than -10 % by modified intention-to-treat analysis .
METHODS	Adverse events were summarised by treatment .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01011413 .
RESULTS	The modified intention-to-treat analysis consisted of 630 patients ( efavirenz 400 = 321 ; efavirenz 600 = 309 ) .
RESULTS	32 % were women ; 37 % were African , 33 % were Asian , and 30 % were white .
RESULTS	The mean baseline CD4 cell count was 273 cells per L ( SD 99 ) and median plasma HIV-RNA was 475 log10 copies per mL ( IQR 088 ) .
RESULTS	The proportion of participants with a viral load below 200 copies per mL at week 48 was 941 % for efavirenz 400 mg and 922 % for 600 mg ( difference 185 % , 95 % CI -21 to 579 ) .
RESULTS	CD4 T-cell counts at week 48 were significantly higher for the 400 mg group than for the 600 mg group ( mean difference 25 cells per L , 95 % CI 6-44 ; p = 001 ) .
RESULTS	We recorded no difference in grade or number of patients reporting adverse events ( efavirenz 400 = 891 % , efavirenz 600 = 884 % ; difference 075 % , 95 % CI -419 to 569 ; p = 077 ) .
RESULTS	Study drug-related adverse events were significantly more frequent in the 600 mg group than in the 400 mg group ( 146 % [ 47 ] vs 118 [ 37 ] ) , difference -105 % , 95 % CI -182 to -28 ; p = 001 ) and significantly fewer patients with these events stopped treatment ( 400 mg = 6 [ 2 % ] , 600 mg = 18 [ 6 % ] , difference -396 % , 95 % CI -696 to -095 ; p = 001 ) .
CONCLUSIONS	Our findings suggest that a reduced dose of 400 mg efavirenz is non-inferior to the standard dose of 600 mg , when combined with tenofovir and emtricitabine during 48 weeks in ART-naive adults with HIV-1 infection .
CONCLUSIONS	Adverse events related to the study drug were more frequent with 600 mg efavirenz than with 400 mg .
CONCLUSIONS	Lower dose efavirenz should be recommended as part of routine care .
BACKGROUND	Bill & Melinda Gates Foundation , University of New South Wales .

###25499305
OBJECTIVE	The purpose of this study was to evaluate the safety and efficacy of excimer laser atherectomy ( ELA ) with adjunctive percutaneous transluminal angioplasty ( PTA ) versus PTA alone for treating patients with chronic peripheral artery disease with femoropopliteal bare nitinol in-stent restenosis ( ISR ) .
BACKGROUND	Femoropopliteal stenting has shown superiority to PTA for lifestyle-limiting claudication and critical limb ischemia , although treating post-stenting artery reobstruction , or ISR , remains challenging .
METHODS	The multicenter , prospective , randomized , controlled EXCITE ISR ( EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis ) trial was conducted across 40 U.S. centers .
METHODS	Patients with Rutherford Class 1 to 4 and lesions of target lesion length 4 cm , vessel diameter 5 to 7 mm were enrolled and randomly divided into ELA + PTA and PTA groups by a 2:1 ratio .
METHODS	The primary efficacy endpoint was target lesion revascularization ( TLR ) at 6-month follow up .
METHODS	The primary safety endpoint was major adverse event ( death , amputation , or TLR ) at 30 days post-procedure .
RESULTS	Study enrollment was stopped at 250 patients due to early efficacy demonstrated at a prospectively-specified interim analysis .
RESULTS	A total of 169 ELA + PTA subjects ( 62.7 % male ; mean age 68.5 9.8 years ) and 81 PTA patients ( 61.7 % male ; mean age 67.8 10.3 years ) were enrolled .
RESULTS	Mean lesion length was 19.6 12.0 cm versus 19.3 11.9 cm , and 30.5 % versus 36.8 % of patients exhibited total occlusion .
RESULTS	ELA + PTA subjects demonstrated superior procedural success ( 93.5 % vs. 82.7 % ; p = 0.01 ) with significantly fewer procedural complications .
RESULTS	ELA + PTA and PTA subject 6-month freedom from TLR was 73.5 % versus 51.8 % ( p < 0.005 ) , and 30-day major adverse event rates were 5.8 % versus 20.5 % ( p < 0.001 ) , respectively .
RESULTS	ELA + PTA was associated with a 52 % reduction in TLR ( hazard ratio : 0.48 ; 95 % confidence interval : 0.31 to 0.74 ) .
CONCLUSIONS	The EXCITE ISR trial is the first large , prospective , randomized study to demonstrate superiority of ELA + PTA versus PTA alone for treating femoropopliteal ISR .
CONCLUSIONS	( Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis [ EXCITE ISR ] ; NCT01330628 ) .

###25517348
BACKGROUND	In patients with acute ischemic stroke caused by a proximal intracranial arterial occlusion , intraarterial treatment is highly effective for emergency revascularization .
BACKGROUND	However , proof of a beneficial effect on functional outcome is lacking .
METHODS	We randomly assigned eligible patients to either intraarterial treatment plus usual care or usual care alone .
METHODS	Eligible patients had a proximal arterial occlusion in the anterior cerebral circulation that was confirmed on vessel imaging and that could be treated intraarterially within 6 hours after symptom onset .
METHODS	The primary outcome was the modified Rankin scale score at 90 days ; this categorical scale measures functional outcome , with scores ranging from 0 ( no symptoms ) to 6 ( death ) .
METHODS	The treatment effect was estimated with ordinal logistic regression as a common odds ratio , adjusted for prespecified prognostic factors .
METHODS	The adjusted common odds ratio measured the likelihood that intraarterial treatment would lead to lower modified Rankin scores , as compared with usual care alone ( shift analysis ) .
RESULTS	We enrolled 500 patients at 16 medical centers in The Netherlands ( 233 assigned to intraarterial treatment and 267 to usual care alone ) .
RESULTS	The mean age was 65 years ( range , 23 to 96 ) , and 445 patients ( 89.0 % ) were treated with intravenous alteplase before randomization .
RESULTS	Retrievable stents were used in 190 of the 233 patients ( 81.5 % ) assigned to intraarterial treatment .
RESULTS	The adjusted common odds ratio was 1.67 ( 95 % confidence interval [ CI ] , 1.21 to 2.30 ) .
RESULTS	There was an absolute difference of 13.5 percentage points ( 95 % CI , 5.9 to 21.2 ) in the rate of functional independence ( modified Rankin score , 0 to 2 ) in favor of the intervention ( 32.6 % vs. 19.1 % ) .
RESULTS	There were no significant differences in mortality or the occurrence of symptomatic intracerebral hemorrhage .
CONCLUSIONS	In patients with acute ischemic stroke caused by a proximal intracranial occlusion of the anterior circulation , intraarterial treatment administered within 6 hours after stroke onset was effective and safe .
CONCLUSIONS	( Funded by the Dutch Heart Foundation and others ; MR CLEAN Netherlands Trial Registry number , NTR1804 , and Current Controlled Trials number , ISRCTN10888758 . )

###24721334
OBJECTIVE	To test the efficacy of self-regulation ( SR ) for promoting task performance and motor and cognitive functions .
METHODS	Pilot randomized controlled trial .
METHODS	Rehabilitation unit .
METHODS	Inpatients with acute poststroke ( N = 44 ) after a cerebral infarction aged 60 years .
METHODS	Patients were randomly assigned to the SR ( n = 24 ) or functional rehabilitation ( control ; n = 20 ) intervention .
METHODS	The SR intervention consisted of 1 week of therapist-supervised practices of daily tasks using SR of one 's own performance ( five 1-h sessions ) .
METHODS	Patients in the control intervention practiced the same daily tasks with a therapist 's demonstration and guidance .
METHODS	Performance of tasks , including household and monetary transaction tasks ; FIM ; Fugl-Meyer Assessment ( FMA ) ; and Color Trails Test ( CTT ) .
RESULTS	The SR group showed significant improvement in all tasks ( median difference , 1-2 ; effect size [ r ] = .74 -.89 ) versus none ( median difference , 0-0 .5 ) in the control group .
RESULTS	Results of the FIM ( P < .001 , r = .87 in the motor subscale ; P < .001 , r = .49 in the cognitive subscale ) , FMA ( P < .001 , r = .84 for upper extremity motor function and r = .63 for lower extremity motor function ) , and CTT ( P = .002 , r = .72 ) of the SR group improved .
RESULTS	The SR group outperformed their control counterparts in 4 of the 5 tasks ( median difference , 1 ; r = .30 -.52 ) and in the FIM motor subscale ( P = .002 , r = .47 ) , but not in the cognitive subscale and motor and cognitive functions .
CONCLUSIONS	SR appears useful for improving task performance that demands both motor and cognitive abilities by promoting information processing and active learning .

###24595567
BACKGROUND	Tofacitinib is a novel , oral Janus kinase inhibitor currently under investigation for plaque psoriasis .
METHODS	This exploratory analysis of a Phase IIb , 12-week , dose-ranging study ( clinicaltrials.gov identifier : NCT00678210 ) evaluated tofacitinib efficacy in four body regions of patients with moderate-to-severe chronic plaque psoriasis .
METHODS	Patients ( n = 197 ) were randomized to tofacitinib 2 , 5 , or 15 mg , or placebo , twice daily ( BID ) .
METHODS	Psoriasis Area and Severity Index ( PASI ) score , body surface area values and change from baseline to week 12 were measured according to body region ( head/neck , upper limbs , trunk and lower limbs ) .
METHODS	Change in Target Plaque Severity Score ( TPSS ) from baseline to week 12 was measured according to typically responsive as well as non-responsive treatment areas .
RESULTS	At week 12 , mean improvements in PASI and body surface area values were significantly greater with tofacitinib doses vs placebo across all four body regions measured ( P < 0.0001 ) .
RESULTS	TPSS in responsive areas decreased ( improved ) with tofacitinib 2 , 5 , and 15 mg BID vs placebo : -4.35 , -4.79 and -6.32 , vs -2.06 , respectively ( P < 0.0001 ) .
RESULTS	In non-responsive areas , TPSS decreased with tofacitinib 2 , 5 , and 15 mg BID vs placebo : -3.74 , -4.60 and -6.15 , vs -2.23 , respectively ( P < 0.01 ) .
CONCLUSIONS	Short-term ( 12-week ) treatment with oral tofacitinib produced clinical improvement across all body regions assessed in patients with moderate-to-severe plaque psoriasis , including areas typically non-responsive to treatment .

###25251929
BACKGROUND	Exercise training improves physical fitness , insulin resistance , and endothelial function in type 2 diabetes .
BACKGROUND	Hypoxia may further optimize these beneficial effects .
BACKGROUND	The aim of this study was to compare the effects of hypoxic versus normoxic exercise training on physical fitness , endothelial function , and insulin resistance in type 2 diabetes .
METHODS	Peak oxygen consumption , flow mediated dilation ( endothelial function ) , and glucose homeostasis were assessed in 19 patients ( 557 years ) before and after an 8-week intervention .
METHODS	Subjects were randomly allocated to normoxic ( 21 % O2 , n = 9 ) or hypoxic ( 16.5 % O2 , n = 10 ) exercise training .
METHODS	Endothelium-independent dilation was examined using sublingual administration of glyceryl trinitrate , and used to calculate the ratio between endothelium-dependent and - independent dilation .
RESULTS	Exercise training improved physical fitness and brachial artery ratio between endothelium-dependent and - independent dilation ( both p < 0.05 ) , whilst these exercise training-induced changes were similar in both groups ( interaction-effects p > 0.05 ) .
RESULTS	Exercise training did not significantly change brachial artery flow-mediated dilation or glyceryl trinitrate-response , superficial femoral artery flow-mediated dilation , or glucose homeostasis , whilst hypoxia did not alter the impact of exercise training .
CONCLUSIONS	Contrary to our hypothesis , hypoxia does not potentiate the effect of exercise training on physical fitness , vascular function , or glucose homeostasis in type 2 diabetes .

###25205516
BACKGROUND	The effect of neighborhood and healthcare access factors on cancer outcomes among patients enrolled in navigator programs is not clearly understood .
BACKGROUND	This study assessed associations between : ( i ) neighborhood factors and diagnostic time to resolution ( TTR ) and ( ii ) geographic access and TTR following an abnormal breast or cervical cancer screening test among women participating in the Ohio Patient Navigator Research Program ( OPNRP ) .
METHODS	Patient ( demographic , socioeconomic status , home-to-clinic distance ) and neighborhood ( deprivation , racial segregation ) characteristics of 801 women living in one of 285 census tracts ( CT ) in greater Columbus , Ohio were examined .
METHODS	Randomization to receive navigation occurred at the clinic level .
METHODS	Multilevel Cox regression and spatial analysis were used to estimate effects of various factors on TTR and assess model assumptions , respectively .
RESULTS	TTR increased as neighborhood deprivation increased .
RESULTS	After adjustment for age , friend social support , education , and healthcare status , the TTR among women living in a neighborhood with a moderate median household income ( between $ 36,147 and $ 53,099 ) was shorter compared with women living in low median household income neighborhoods ( < $ 36,147 ; P < 0.05 ) .
RESULTS	There is little evidence that unmeasured confounders are geographically patterned .
CONCLUSIONS	Increased neighborhood socioeconomic deprivation was associated with longer TTR following an abnormal breast or cervical cancer screening test .
CONCLUSIONS	These results highlight the need for addressing patient - and neighborhood-level factors to reduce cancer disparities among underserved populations .

###24968814
BACKGROUND	Hypoxemia is a surrogate marker for periprocedural endoscopic complications .
BACKGROUND	There are no data comparing the safety of propofol sedation with another sedative regimen in medical thoracoscopy .
OBJECTIVE	To evaluate whether sedation with propofol is as safe and effective as sedation with midazolam .
METHODS	Ninety consecutive patients undergoing medical thoracoscopy were randomly allocated to receive either intravenous propofol or midazolam .
METHODS	Predefined periprocedural complications included hypoxemia , hypotension , bleeding , need for airway insertion , mechanical ventilation , intensive care unit transfer and death .
METHODS	The primary endpoint was the mean lowest oxygen saturation during the procedure .
RESULTS	Randomized groups had similar demographics ( 64 16 years , 57 % male , 91 % American Society of Anesthesiologists class III-IV ) and a balanced distribution of procedures .
RESULTS	The mean lowest oxygen saturation during the procedure was significantly lower in the propofol group as compared to the midazolam group ( 93 6 vs. 96 3 % , p = 0.007 ) .
RESULTS	Patients randomized to propofol showed more episodes of hypoxemia ( 27 vs. 4 % , p = 0.007 ) and hypotension ( 82 vs. 40 % , p < 0.0001 ) .
RESULTS	No procedure had to be aborted .
RESULTS	None of the patients required an artificial airway , mechanical ventilation or intensive care unit care , and none died .
CONCLUSIONS	As assessed by the surrogate marker hypoxemia , propofol should not be considered the first choice for sedation in medical thoracoscopy .

###24854306
BACKGROUND	Given that the observed prevalence and time course of critical illness-related corticosteroid insufficiency ( CIRCI ) remain inconsistent in trauma patients , the present study was designed to investigate the prevalence , time course , and effect of CIRCI on the outcome of critically ill patients with multiple injuries .
METHODS	In this multicenter , prospective cohort study , patients with multiple injuries in seven intensive care units in China were enrolled .
METHODS	Adrenocorticotropic hormone ( ACTH ) stimulation tests were performed by administering intravenously 250 g of synthetic ACTH on Days 1 , 2 , 3 , 5 , and 7 after traumatic injury .
METHODS	CIRCI was defined as baseline cortisol level of less than 10 g/dL or a cortisol ( difference baseline and highest cortisol level at 30 or 60 minutes after ACTH stimulation ) less than 9 g/dL .
METHODS	The incidence and time course of CIRCI and 28-day mortality were recorded .
RESULTS	CIRCI occurred in 54.3 % ( 38 of 70 ) of the patients with multiple injuries , including 10 patients with total cortisol level of less than 10 g/dL and 28 patients with cortisol of less than 9 g/dL .
RESULTS	Most ( 94.7 % ) diagnosis of CIRCI was made in the first 48 hours after traumatic injury .
RESULTS	The CIRCI patients had significantly more severe illness on the day of admission .
RESULTS	At each time point , the baseline cortisol level was comparable between the CIRCI and non-CIRCI patients , while cortisol in the CIRCI group was significantly lower compared with the non-CIRCI group .
RESULTS	The CIRCI patients with a cortisol of less than 9 g/dL had a significantly higher 28-day mortality ( 39.3 % ) compared with those with a baseline cortisol level of less than 10 g/dL ( 10.0 % ) and non-CIRCI patients ( 6.3 % ) .
RESULTS	Only cortisol of less than 9 g/dL but not baseline cortisol level of less than 10 g/dL seemed to be an independent risk factor for death ( odds ratio , 1.19 ; p = 0.023 ) .
CONCLUSIONS	CIRCI is common in critically ill trauma population and usually occurs in the early stages .
CONCLUSIONS	Only the results of the ACTH stimulation test but not baseline cortisol level was associated with poor prognosis .
METHODS	Prognostic study , level II .

###24687847
OBJECTIVE	To test a pathway through which a tailored , pain management education-coaching intervention could contribute to better cancer pain control through the effects of patients ' communication about pain on physician prescribing of pain medication .
METHODS	Secondary analysis of data from a randomized controlled trial that tested the effects of a tailored education-coaching intervention on pain control for patients with advanced cancer .
METHODS	The current analysis focused on a subset of the patients ( n = 135 ) who agreed to have their consultations audio-recorded .
METHODS	Patients ' active communication about pain ( e.g. , expressing questions , concerns , and preferences about pain-related issues ) was coded from audio-recordings .
METHODS	Change in pain medication was measured by patient self-report .
METHODS	Improvement in pain control was scored as the difference between baseline pain score and pain reported at 6 weeks .
RESULTS	Patients ' pain-related communication was a significant predictor of patient-reported changes in physician prescribing of pain medication ( p < .0001 ) and mediated the effect of baseline pain on medication change .
RESULTS	Other predictors of change in pain medication were age ( younger ) and having participated in the intervention ( as opposed to usual care ) .
RESULTS	Of the patients reporting adjustment in pain medications , 49 % experienced better pain control compared with only 27 % of patients reporting no change in pain management ( p < .02 ) .
CONCLUSIONS	Cancer patients who ask questions , express concerns , and state preferences about pain-related matters can prompt physicians to change their pain management regimen , which in turn may lead to better pain control .
CONCLUSIONS	Future research should model pathways through which clinician-patient communication can lead to better cancer outcomes .

###24361986
BACKGROUND	Daily life movements require balance ability .
BACKGROUND	Good balance control is closely related to body stability and its development .
BACKGROUND	Therefore , balance training is necessary for any age group .
OBJECTIVE	This study proposes the combination of Kinect and virtual reality to build an information platform of interactive scenarios , for practice and evaluation of balance ability .
OBJECTIVE	Real-time monitoring of SpO <formula> _ 2 </formula> , pulse rate , velocity and reaction time during the training process is presented for the training activities of elderly physical function .
METHODS	Based on the indicators of balance ability , this information platform sets out various training activities to improve balance ability , making the supposedly tedious process fun and vivid and leading to much better training results .
RESULTS	The data ( SpO <formula> _ 2 </formula> , pulse rate , velocity , reaction time ) collected from this platform can be sorted and analysed , and the results used to evaluate the performance of balance training , and referenced for follow-up planning in the future .
RESULTS	The real-time pulse rate and SpO <formula> _ 2 </formula> measurement information indicating the training activities for the elderly to maintain physical function has a positive significance .
RESULTS	A noninvasive and unconstrained real-time method to detect the pulse rate and SpO <formula> _ 2 </formula> during exercises is presented .
RESULTS	The results of balance assessment scale testing of BBS and TUG for the experimental group show that effective balance really improved .
RESULTS	The difference between the experimental group and the control group was achieved by using paired t-test .
RESULTS	The data were analysed by the descriptive statistics on significant level of P < 0.01 .
CONCLUSIONS	From the training results of the participants , we know that the information platform developed for enhancing balance ability is in line with practical needs .
CONCLUSIONS	Furthermore , the fun and interesting game-like exercises it introduces are very helpful in improving balance ability , and certainly in preventing falls .

###24588407
OBJECTIVE	The primary purpose of the study was to determine whether Multisystemic Therapy adapted for health care settings ( MST-HC ) improved asthma management and health outcomes in high-risk African American adolescents with asthma .
METHODS	Eligibility included self-reported African American ethnicity , ages 12 to 16 , moderate to severe asthma , and an inpatient hospitalization or at least 2 emergency department visits for asthma in the last 12 months .
METHODS	Adolescents and their families ( N = 170 ) were randomized to MST-HC or in-home family support .
METHODS	Data were collected at baseline and posttreatment ( 7 months ) based on an asthma management interview , medication adherence phone diary , and lung function biomarker ( forced expiratory volume in 1 s [ FEV1 ] ) .
METHODS	Analyses were conducted using linear mixed modeling for continuous outcomes and generalized linear mixed modeling for binary outcomes .
RESULTS	In intent-to-treat analyses , adolescents randomized to MST-HC were more likely to improve on 2 of the measures of medication adherence and FEV1 .
RESULTS	Per-protocol analysis demonstrated that MST-HC had a medium effect on adherence measures and had a small to medium effect on lung function and the adolescent 's response to asthma exacerbations .
CONCLUSIONS	There are few interventions that have been shown to successfully improve asthma management in minority youth at highest risk for poor morbidity and mortality .
CONCLUSIONS	MST , a home-based psychotherapy originally developed to target behavior problems in youth , improved asthma management and lung function compared to a strong comparison condition .
CONCLUSIONS	Further follow-up is necessary to determine whether MST-HC reduces health care utilization accounting for seasonal variability .
CONCLUSIONS	A limitation to the study is that a greater number of participants in the control group came from single-parent families than in the MST group .

###24760401
OBJECTIVE	Icosapent ethyl ( IPE ) is a high-purity prescription form of eicosapentaenoic acid ( EPA ) ethyl ester approved to reduce triglyceride levels in patients with severe ( 5.65 mmol/L ) hypertriglyceridemia .
OBJECTIVE	EPA , the active metabolite of IPE , is mainly metabolized via - oxidation , and studies suggest that omega-3 fatty acids such as EPA may have antithrombotic effects .
OBJECTIVE	The objective of this study was to evaluate the effect of IPE on the pharmacokinetic and anticoagulation pharmacodynamics of warfarin , a substrate of cytochrome P450 2C9-mediated metabolism .
METHODS	Healthy adults received oral warfarin ( 25 mg ) on day 1 , oral IPE ( 4 g/day ) on days 8-35 , and co-administration on Day 29 .
METHODS	Primary pharmacokinetic end points were area under the concentration-versus-time curve from zero to infinity ( AUC ( 0 - ) ) and maximum plasma concentration ( C ( max ) ) for R - and S-warfarin ; pharmacodynamic end points were area under the international normalized ratio ( INR ) effect-time curve after the warfarin dose ( AUC ( INR ) ) and maximum INR ( INR ( max ) ) .
RESULTS	Twenty-five subjects completed the study .
RESULTS	AUC ( 0 - ) and C max ratios of geometric means for both R - and S-warfarin following co-administration of warfarin with versus without IPE were within the 90 % confidence intervals of 0.80-1 .25 .
RESULTS	AUC ( INR ) , INR ( max ) , and ratios were also similar .
CONCLUSIONS	IPE 4 g/day did not significantly change the single-dose AUC ( 0 - ) or C ( max ) of R - and S-warfarin or the anticoagulation pharmacodynamics of warfarin when co-administered as racemic warfarin at 25 mg .
CONCLUSIONS	Co-administration of these drugs was safe and well tolerated in this study of healthy adult subjects .

###24225069
BACKGROUND	The publication of protocols by medical journals is increasingly becoming an accepted means for promoting good quality research and maximising transparency .
BACKGROUND	Recently , Finfer and Bellomo have suggested the publication of statistical analysis plans ( SAPs ) .
BACKGROUND	The aim of this paper is to make public and to report in detail the planned analyses that were approved by the Trial Steering Committee in May 2010 for the principal papers of the PACE ( Pacing , graded Activity , and Cognitive behaviour therapy : a randomised Evaluation ) trial , a treatment trial for chronic fatigue syndrome .
BACKGROUND	It illustrates planned analyses of a complex intervention trial that allows for the impact of clustering by care providers , where multiple care-providers are present for each patient in some but not all arms of the trial .
RESULTS	The trial design , objectives and data collection are reported .
RESULTS	Considerations relating to blinding , samples , adherence to the protocol , stratification , centre and other clustering effects , missing data , multiplicity and compliance are described .
RESULTS	Descriptive , interim and final analyses of the primary and secondary outcomes are then outlined .
CONCLUSIONS	This SAP maximises transparency , providing a record of all planned analyses , and it may be a resource for those who are developing SAPs , acting as an illustrative example for teaching and methodological research .
CONCLUSIONS	It is not the sum of the statistical analysis sections of the principal papers , being completed well before individual papers were drafted .
BACKGROUND	ISRCTN54285094 assigned 22 May 2003 ; First participant was randomised on 18 March 2005 .

###24580721
BACKGROUND	The purpose of this study was to evaluate the efficacy of a self-guided CD-ROM program ( `` Headstrong '' ) containing cognitive-behavioral self-management strategies versus an educational CD-ROM program for treating headaches , headache-related disability , and quality of life .
METHODS	Participants were 35 children ages 7-12years with migraine recruited from one university medical center and two children 's hospital headache clinics .
METHODS	Participants were randomly assigned to complete the Headstrong or educational control CD-ROM program over a 4-week period .
METHODS	Data on headache frequency , duration , and severity , migraine-related disability , and quality of life ( QOL ) were obtained at baseline , post-intervention , and 3-months post-intervention .
RESULTS	At post-intervention , Headstrong resulted in lower severity ( on a 10-point scale ) than the control group by child report ( 5.061.50 SD vs. 6.251.92 SD , p = 0.03 , ES = 0.7 ) .
RESULTS	At 3-months post-intervention , parents reported less migraine-related disability ( on the PedMIDAS ) in the Headstrong group compared to the control group ( 1.362.06 SD vs. 5.186.40 SD ; p = 0.04 , ES = 0.8 ) .
RESULTS	There were no other group differences at post treatment or at 3-months post-intervention .
CONCLUSIONS	When compared to an educational control , Headstrong resulted in lower pain severity at post-treatment and less migraine-related disability at 3-months post-intervention , by child and parent report respectively .
CONCLUSIONS	Headache frequency and quality of life did not change more for Headstrong versus control .
CONCLUSIONS	Additional research is needed on the Headstrong Program to increase its efficacy and to test it with a larger sample recruited from multiple centers simultaneously .

###25223267
BACKGROUND	Vaccines may have non-specific effects .
BACKGROUND	An observational study from Guinea-Bissau suggested that oral polio vaccine at birth ( OPV0 ) provided with Bacillus Calmette-Gurin ( BCG ) vaccine was associated with down-regulation of the immune response to BCG vaccine 6 weeks later .
BACKGROUND	Based on the previous finding , we wanted to test our a priori hypothesis that OPV would dampen the immune response to BCG , and secondarily to test immune responses to other antigens .
METHODS	The study was conducted at the Bandim Health Project in Guinea-Bissau in 2009-2010 .
METHODS	Infants were randomised to OPV0 + BCG versus BCG alone at birth , and subsequently randomised to have a blood sample taken at 2 , 4 or 6 weeks post-randomisation .
METHODS	Excreted levels of cytokines ( IL-2 , IL-5 , IL-10 , TNF - and IFN - ) were measured from whole blood in vitro stimulations with a panel of recall vaccine antigens ( BCG , PPD , OPV ) , mitogen ( PHA ) or innate agonists ( LPS , Pam3cys , PolyI : C ) .
METHODS	Additionally , we measured the local reaction to BCG , white blood cell distribution , C-reactive protein ( CRP ) and retinol-binding protein ( RBP ) .
METHODS	Cytokine production was analysed as the prevalence ratios of responders above the median .
RESULTS	Blood samples from 430 infants ( 209 OPV0 + BCG ; 221 BCG alone ) were analysed .
RESULTS	There were no strong differences in effects 2 , 4 and 6 weeks post-randomisation and subsequent analyses were performed on the pooled data .
RESULTS	As hypothesised , receiving OPV0 + BCG versus BCG alone was associated with significantly lower prevalence of IFN - responses to PPD ( prevalence ratio ( PR ) : 0.84 ( 0.72-0 .98 ) ) and reduced IL-5 to PPD ( PR : 0.78 ( 0.64-0 .96 ) ) .
RESULTS	No effects were observed for CPR , RBP , white blood cell distribution , or BCG scar prevalence .
CONCLUSIONS	The results corroborate that OPV attenuates the immune response to co-administered BCG at birth .

###25473176
OBJECTIVE	To investigate the effects of a low fermentable , oligosaccharides , disaccharides , monosaccharides and polyols diet ( LFD ) and the probiotic Lactobacillus rhamnosus GG ( LGG ) in irritable bowel syndrome ( IBS ) .
METHODS	Randomised , unblinded controlled trial on the effect of 6-wk treatment with LFD , LGG or a normal Danish/Western diet ( ND ) in patients with IBS fulfilling Rome III diagnostic criteria , recruited between November 2009 and April 2013 .
METHODS	Patients were required to complete on a weekly basis the IBS severity score system ( IBS-SSS ) and IBS quality of life ( IBS-QOL ) questionnaires in a specially developed IBS web self-monitoring application .
METHODS	We investigated whether LFD or LGG could reduce IBS-SSS and improve QOL in IBS patients .
RESULTS	One hundred twenty-three patients ( median age 37 years , range : 18-74 years ) , 90 ( 73 % ) females were randomised : 42 to LFD , 41 to LGG and 40 to ND .
RESULTS	A significant reduction in mean SD of IBS-SSS from baseline to week 6 between LFD vs LGG vs ND was revealed : 133 122 vs 68 107 , 133 122 vs 34 95 , P < 0.01 .
RESULTS	Adjusted changes of IBS-SSS for baseline covariates showed statistically significant reduction of IBS-SSS in LFD group compared to ND ( IBS-SSS score 75 ; 95 % CI : 24-126 , P < 0.01 ) , but not in LGG compared to ND ( IBS-SSS score 32 ; 95 % CI : 18-80 , P = 0.20 ) .
RESULTS	IBS-QOL was not altered significantly in any of the three groups : mean SD in LFD 8 18 vs LGG 7 17 , LFD 8 18 vs ND 0.1 15 , P = 0.13 .
CONCLUSIONS	Both LFD and LGG are efficatious in patients with IBS .

###24809787
OBJECTIVE	To determine the efficacy of the Airtraq versus the McCoy laryngoscope as intubation devices with the neck stabilized by a rigid cervical collar .
METHODS	Prospective , randomized , double-blinded study .
METHODS	Jawaharlal Nehru Medical College .
METHODS	60 ASA physical status 1 , 2 , and 3 patients , aged 18-70 years , scheduled for various surgical procedures requiring tracheal intubation for surgical anesthesia .
METHODS	Patients were randomly allocated to undergo intubation with the McCoy ( n = 30 ) or Airtraq ( n = 30 ) laryngoscope .
RESULTS	Differences in intubation times between the Airtraq and the McCoy laryngoscope , modified Cormack-Lehane score , percentage of glottic opening ( POGO ) score , and airway trauma were compared .
RESULTS	Overall intubation success rates were 100 % with both devices and a similar number of intubation attempts were required .
RESULTS	However , the mean ( SD ) time required for successful intubation was shorter with the Airtraq ( 28.73 6.39 sec ) than the McCoy laryngoscope ( 39.11 14.01 sec ; P < 0.0001 ) .
RESULTS	The frequencies of intubation complications were similar .
RESULTS	Esophageal intubation occurred in 4 cases but only with the McCoy laryngoscope .
CONCLUSIONS	Intubation time was shorter with the Airtraq than the McCoy laryngoscope , even though the overall success rates between the two devices were similar .

###24378686
OBJECTIVE	Physicians may be important sources of sexuality information and preventive services , and one-on-one confidential time during health maintenance visits is recommended to allow discussions of sexual development , behavior , and risk reduction .
OBJECTIVE	However , little is known about the occurrence and characteristics of physician-adolescent discussions about sexuality .
OBJECTIVE	To examine predictors of time spent discussing sexuality , level of adolescent participation , and physician and patient characteristics associated with sexuality discussions during health maintenance visits by early and middle adolescents .
METHODS	Observational study of audio-recorded conversations between 253 adolescents ( mean age , 14.3 years ; 53 % female ; 40 % white ; 47 % African American ) and 49 physicians ( 82 % pediatricians ; 84 % white ; 65 % female ; mean age , 40.9 years ; mean [ SD ] duration in practice , 11.8 [ 8.7 ] years ) coded for sexuality content at 11 clinics ( 3 academic and 8 community-based practices ) located throughout the Raleigh/Durham , North Carolina , area .
METHODS	Total time per visit during which sexuality issues were discussed .
METHODS	RESULTS One hundred sixty-five ( 65 % ) of all visits had some sexual content within it .
METHODS	The average time of sexuality talk was 36 seconds ( 35 % 0 seconds ; 30 % 1-35 seconds ; and 35 % 36 seconds ) .
METHODS	Ordinal logistic regression ( outcome of duration : 0 , 1-35 , or 36 seconds ) , adjusted for clustering of patients within physicians , found that female patients ( odds ratio [ OR ] = 2.58 ; 95 % CI , 1.53-4 .36 ) , older patients ( OR = 1.37 ; 95 % CI , 1.13-1 .65 ) , conversations with explicit confidentiality discussions ( OR = 4.33 ; 95 % CI , 2.58-7 .28 ) , African American adolescents ( OR = 1.58 ; 95 % CI , 1.01-2 .48 ) , and longer overall visit ( OR = 1.07 ; 95 % CI , 1.03-1 .11 ) were associated with more sexuality talk , and Asian physicians were associated with less sexuality talk ( OR = 0.13 ; 95 % CI , 0.08-0 .20 ) .
METHODS	In addition , the same significant associations between adolescent , physician , and visit characteristics were significantly associated with greater adolescent participation .
CONCLUSIONS	Our study may be the first to directly observe sexuality talk between physicians and adolescents .
CONCLUSIONS	We found that one-third of all adolescents had annual visits without any mention of sexuality issues ; when sexuality talk occurred , it was brief .
CONCLUSIONS	Research is needed to identify successful strategies physicians can use to engage adolescents in discussions about sexuality to help promote healthy sexual development and decision making .
BACKGROUND	clinicaltrials.gov Identifier : NCT01040975 .

###25266222
OBJECTIVE	To assess the effectiveness of an integrated early child development intervention , combining stimulation and micronutrient supplementation and delivered on a large scale in Colombia , for children 's development , growth , and hemoglobin levels .
METHODS	Cluster randomized controlled trial , using a 2 2 factorial design , with municipalities assigned to one of four groups : psychosocial stimulation , micronutrient supplementation , combined intervention , or control .
METHODS	96 municipalities in Colombia , located across eight of its 32 departments .
METHODS	1420 children aged 12-24 months and their primary carers .
METHODS	Psychosocial stimulation ( weekly home visits with play demonstrations ) , micronutrient sprinkles given daily , and both combined .
METHODS	All delivered by female community leaders for 18 months .
METHODS	Cognitive , receptive and expressive language , and fine and gross motor scores on the Bayley scales of infant development-III ; height , weight , and hemoglobin levels measured at the baseline and end of intervention .
RESULTS	Stimulation improved cognitive scores ( adjusted for age , sex , testers , and baseline levels of outcomes ) by 0.26 of a standard deviation ( P = 0.002 ) .
RESULTS	Stimulation also increased receptive language by 0.22 of a standard deviation ( P = 0.032 ) .
RESULTS	Micronutrient supplementation had no significant effect on any outcome and there was no interaction between the interventions .
RESULTS	No intervention affected height , weight , or hemoglobin levels .
CONCLUSIONS	Using the infrastructure of a national welfare program we implemented the integrated early child development intervention on a large scale and showed its potential for improving children 's cognitive development .
CONCLUSIONS	We found no effect of supplementation on developmental or health outcomes .
CONCLUSIONS	Moreover , supplementation did not interact with stimulation .
CONCLUSIONS	The implementation model for delivering stimulation suggests that it may serve as a promising blueprint for future policy on early childhood development.Trial registration Current Controlled trials ISRCTN18991160 .

###24927275
OBJECTIVE	To study the influence of acupuncture at Waiguan ( TE5 ) on the functional connectivity of the central nervous system of patients with ischemic stroke .
METHODS	Twenty-four patients with ischemic stroke in the left basal ganglia were randomized based on gender to receive TE5 acupuncture ( n = 12 ) or nonacupoint acupuncture ( n = 12 ) .
METHODS	Each group underwent sham acupuncture and then verum acupuncture while being scanned with functional magnetic resonance imaging .
METHODS	Six regions of interest ( ROI ) were defined , including bilateral motor , somatosensory , and bilateral basal ganglia areas .
METHODS	The functional connectivity between these ROIs and all voxels of the brain was analyzed in Analysis of Functional NeuroImages ( AFNI ) to explore the differences between verum acupuncture and sham acupuncture at TE5 and between TE5 acupuncture and nonacupoint acupuncture .
METHODS	The participants were blinded to the allocation .
RESULTS	The effect of acupuncture on six seed-associated networks was explored .
RESULTS	The result demonstrated that acupuncture at Waiguan ( TE5 ) can regulate the sensorimotor network of the ipsilesional hemisphere , stimulate the contralesional sensorimotor network , increase cooperation of bilateral sensorimotor networks , and change the synchronization between the cerebellum and cerebrum .
RESULTS	Furthermore , a lot of differences of effect existed between verum acupuncture and sham acupuncture at TE5 , but there was little difference between TE5 acupuncture and nonacupoint acupuncture .
CONCLUSIONS	The modulation of synchronizations between different regions within different brain networks might be the mechanism of acupuncture at Waiguan ( TE5 ) .
CONCLUSIONS	Stimulation of the contralesional sensorimotor network and increase of cooperation of bilateral hemispheres imply a compensatory effect of the intact hemisphere , whereas changes in synchronization might influence the sensorimotor function of the affected side of the body .
BACKGROUND	Chinese Clinical Trial Registry ChiCTR-ONRC-08000255 .

###24314012
BACKGROUND	Severe acute pancreatitis is still a potentially life threatening disease with high mortality .
BACKGROUND	The aim of this study was to evaluate the therapeutic effect of thoracic epidural anaesthesia ( TEA ) on survival , microcirculation , tissue oxygenation and histopathologic damage in an experimental animal model of severe acute pancreatitis in a prospective animal study .
METHODS	In this study , 34 pigs were randomly assigned into 2 treatment groups .
METHODS	After severe acute pancreatitis was induced by intraductal injection of glycodesoxycholic acid in Group 1 ( n = 17 ) bupivacaine ( 0.5 % ; bolus injection 2ml , continuous infusion 4ml/h ) was applied via TEA .
METHODS	In Group 2 ( n = 17 ) no TEA was applied .
METHODS	During a period of 6hours after induction , tissue oxygen tension ( tpO2 ) in the pancreas and pancreatic microcirculation was assessed .
METHODS	Thereafter animals were observed for 7days followed by sacrification and histopathologic examination .
RESULTS	Survival rate after 7days was 82 % in Group 1 ( TEA ) versus 29 % in Group 2 : ( Control ) ( P < 0.05 ) .
RESULTS	Group 1 ( TEA ) also showed a significantly superior microcirculation ( 1,608374 AU versus 1,121510 AU ; P < 0.05 ) and tissue oxygenation ( 21564mmHg versus 13890 mmHG ; P < 0.05 ) as compared to Group 2 ( Control ) .
RESULTS	Consecutively , tissue damage in Group 1 was reduced in the histopathologic scoring ( 5.5 ( 3 to 8 ) versus 8 ( 5.5 to 10 ) ; P < 0.05 ) .
CONCLUSIONS	TEA led to improved survival , enhanced microcirculatory perfusion and tissue oxygenation and resulted in less histopathologic tissue-damage in an experimental animal model of severe acute pancreatitis .

###24885377
BACKGROUND	Persistent atrial fibrillation frequently shows multiple different electrophysiological mechanisms of induction .
BACKGROUND	This heterogeneity causes a low success rate of single procedures of ablation and a high incidence of recurrence .
BACKGROUND	Surgical ablation through bilateral thoracotomy demonstrates better results after a single procedure .
BACKGROUND	Prospective observational studies in inhomogeneous populations without control groups report a remarkable 90 % of success with hybrid or staged procedures of surgical ablation coupled with catheter ablation .
BACKGROUND	In this trial , we will examine the hypothesis that a staged approach involving initial minimally invasive surgical ablation of persistent atrial fibrillation , followed by a second percutaneous procedure in case of recurrence , has a higher success rate than repeated percutaneous procedures .
METHODS	This is a controlled ( 2:1 ) randomized trial comparing use of a percutaneous catheter with minimally invasive transthoracic surgical ablation of persistent atrial fibrillation .
METHODS	The inclusion and exclusion criteria , definitions , and treatment protocols are those reported by the 2012 Expert Consensus Statement on catheter and surgical ablation of atrial fibrillation .
METHODS	Patients will be randomized to either percutaneous catheter ( n = 100 ) or surgical ( n = 50 ) ablation as the first procedure .
METHODS	After 3 months , they are re-evaluated , according to the same guidelines , and receive a second procedure if necessary .
METHODS	Crossover will be allowed and data analyzed on an `` intention-to-treat '' basis .
METHODS	Primary outcomes are the incidence of sinus rhythm at 6 and 12 months and the proportions of patients requiring a second procedure .
CONCLUSIONS	The use of a staged strategy combining surgical and percutaneous approaches might be more favorable in treatment of persistent atrial fibrillation than the controversial single percutaneous ablation .
BACKGROUND	ISRCTN08035058 Reg 06.20.2013 .

###25402666
OBJECTIVE	Postconditioning has been reported to reduce infarct size in ST-segment myocardial infarction ( STEMI ) .
OBJECTIVE	However , recently , few other studies did not show any effect of postconditioning and suggested that it may be even harmful .
OBJECTIVE	We sought to assess whether postconditioning could reduce infarct size and improve myocardial reperfusion in early presenters with STEMI .
METHODS	72 STEMI patients treated with primary percutaneous coronary intervention ( PCI ) were randomly assigned to either the postconditioning ( n = 35 ) or the standard PCI group ( control group ; n = 37 ) .
METHODS	Blood samples were obtained for creatine kinase ( CK ) and its MB isoform ( CK-MB ) within 36 h.
METHODS	The angiographic ( myocardial blush grade , MBG ) and electrocardiographic ( ST-segment resolution , STR ) data were evaluated and compared between groups .
RESULTS	The areas under the curve of CK and CK-MB release were significantly reduced in the postconditioning group compared with the control group ( 38,612.91 25,028.42 vs. 60,547.30 25,264.63 for CK and 5,498.23 3,787.91 vs. 7,443.12 3,561.13 for CK-MB , p < 0.0001 ) .
RESULTS	MBG was significantly better in the postconditioning group than in the control group ( MBG 3 : 82.3 vs. 47.1 % , p = 0.0023 ) .
RESULTS	In the postconditioning group , STR > 70 % was more often observed ( 97.1 vs. 64.1 % , p = 0.0007 ) .
CONCLUSIONS	In patients with STEMI , postconditioning could significantly reduce enzymatic infarct size and improve myocardial reperfusion .

###25775661
BACKGROUND	There are several therapies for treating lupoid leishmaniasis .
BACKGROUND	We compared the effectiveness of intralesional meglumine antimoniate ( MA ) and topical application of trichloroacetic acid ( TCA ) 50 % solution .
METHODS	This study was a randomized clinical trial comprising 60 lupoid leishmaniasis patients .
METHODS	The first group received intralesional MA once a week , and the second group was treated once weekly with TCA 50 % topical solution .
METHODS	The results were recorded once after 8 weeks and then 3 months after the termination of treatment .
RESULTS	The total clearance rates after treatment and after the 3-month follow-up were , respectively , 48.1 % and 40 % in the first group and 44.4 % and 36.6 % in the second group .
RESULTS	There was no significant difference between the two treatment groups ( p = .25 and p = .26 ) .
RESULTS	In both groups , the most common side effect was scarring .
CONCLUSIONS	Having almost the same efficacies , TCA as a topical approach could be as effective as MA in the lupoid leishmaniasis treatment plan .

###24220352
BACKGROUND	The World Health Organization recommends the use of syndromic management for patients presenting with genital ulcer disease ( GUD ) in developing countries .
BACKGROUND	However , effective treatment guidelines depend on a current country-specific GUD etiological profile , which may change over time .
METHODS	From 2004 to 2006 , we conducted a cross-sectional analysis of baseline data from patients presenting with GUD at a reference STI clinic in Lilongwe , Malawi .
METHODS	Participants were enrolled in a randomized clinical trial of acyclovir added to syndromic management and followed up for up to 28 days .
METHODS	Serologies for HIV ( using parallel rapid tests ) , herpes simplex virus type 2 ( HSV-2 ; using Focus HerpeSelect IgG2 ELISA [ Focus Technologies , Cypress Hill , CA ] ) , and syphilis ( rapid plasma reagin confirmed by Treponema pallidum hemagglutination ) were determined , with plasma HIV-1 RNA and CD4 count in HIV-positive patients .
METHODS	Genital ulcer disease etiology was determined by real-time multiplex polymerase chain reaction from lesional swabs .
RESULTS	A total of 422 patients with GUD ( 313 men ; 74 % ) were enrolled .
RESULTS	Overall seroprevalence of HIV-1 , HSV-2 , and syphilis were 61 % , 72 % , and 5 % , respectively .
RESULTS	Ulcer etiology was available for 398 patients and showed the following : HSV-2 , 67 % ; Haemophilus ducreyi , 15 % ; T. pallidum , 6 % ; lymphogranuloma venereum , 6 % ; mixed infections , 14 % , and no etiology , 20 % .
RESULTS	Most HSV-2 ulcers were recurrent ( 75 % ) .
RESULTS	Among all patients with HSV-2 , HIV prevalence was high ( 67 % ) and HIV seroprevalence was higher among patients with recurrent HSV-2 compared with patients with first-episode HSV-2 ( 78 % vs. 39 % , P < 0.001 ) .
CONCLUSIONS	Herpes simplex virus type 2 ulcers are highly prevalent in this symptomatic population and strongly associated with HIV .
CONCLUSIONS	Unlike most locations in sub-Saharan Africa , H. ducreyi remains prevalent in this population and requires periodic monitoring and an appropriate treatment regimen .

###24839034
BACKGROUND	The basic difference between the various common medical laser systems is the wavelength of the emitted light , leading to altered light-tissue interactions due to the optical parameters of the tissue .
BACKGROUND	This study examines laser induced tissue effects in an in vitro tissue model using 1,470 nm diode laser compared to our standard practice for endonasal applications ( 940nm diode laser ) under standardised and reproducible conditions .
BACKGROUND	Additionally , in vivo induced tissue effects following non-contact application with focus on mucosal healing were investigated in a controlled intra-individual design in patients treated for hypertrophy of nasal turbinate .
METHODS	A certified diode laser system emitting the light of = 1470nm was evaluated with regards to its tissue effects ( ablation , coagulation ) in an in vitro setup on porcine liver and turkey muscle tissue model .
METHODS	To achieve comparable macroscopic tissue effects the laser fibres ( 600m core diameter ) were fixed to a computer controlled stepper motor and the laser light was applied in a reproducible procedure under constant conditions .
METHODS	For the in vivo evaluation , 20 patients with nasal obstruction due to hyperplasia of inferior nasal turbinates were included in this prospective randomised double-blinded comparative trial .
METHODS	The endoscopic controlled endonasal application of = 1470nm on the one and = 940nm on the other side , both in ` non-contact ' mode , was carried out as an outpatient procedure under local anaesthesia .
METHODS	The postoperative wound healing process ( mucosal swelling , scab formation , bleeding , infection ) was endoscopically documented and assessed by an independent physician .
RESULTS	In the experimental setup , the 1,470 nm laser diode system proved to be efficient in inducing tissue effects in non-contact mode with a reduced energy factor of 5-10 for highly perfused liver tissue to 10-20 for muscle tissue as compared to the 940nm diode laser system .
RESULTS	In the in vivo evaluation scab formation following laser surgery as assessed clinically on endonasal endoscopy was significantly reduced on 1,470 nm treated site compared to 940nm diode laser treated site .
CONCLUSIONS	Diode laser system ( 1,470 nm ) induces efficient tissue effects compared to 940nm diode laser system as shown in the tissue model experiment .
CONCLUSIONS	From the clinical point of view , the healing process following non-contact diode laser application revealed to be improved using 1,470 nm diode laser compared to our standard diode laser practise with 940nm .

###24948586
BACKGROUND	Relapsed multiple myeloma has no standard treatment , and the role of autologous stem-cell transplantation ( ASCT ) has not been fully defined .
BACKGROUND	We aimed to compare high-dose melphalan plus salvage ASCT with cyclophosphamide in patients with relapsed multiple myeloma who had previously undergone ASCT .
METHODS	This multicentre , randomised , open-label , phase 3 study recruited patients aged at least 18 years with multiple myeloma who needed treatment for first progressive or relapsed disease at least 18 months after a previous ASCT from 51 centres across the UK .
METHODS	Before randomisation , eligible patients received bortezomib , doxorubicin , and dexamethasone ( PAD ) induction therapy and then underwent peripheral blood stem-cell mobilisation and harvesting if applicable .
METHODS	Eligible patients ( with adequate stem-cell harvest ) were randomly assigned ( 1:1 ) , using an automated telephone randomisation line , to either high-dose melphalan 200 mg/m ( 2 ) plus salvage ASCT or oral cyclophosphamide ( 400mg/m ( 2 ) per week for 12 weeks ) .
METHODS	Randomisation was stratified by length of first remission or plateau and response to PAD re-induction therapy .
METHODS	The primary endpoint was time to disease progression , analysed by intention to treat .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00747877 , and EudraCT , number 2006-005890-24 .
RESULTS	Between April 16 , 2008 , and Nov 19 , 2012 , 297 patients were registered , of whom 293 received PAD re-induction therapy .
RESULTS	Between Aug 26 , 2008 , and Nov 16 , 2012 , 174 patients with sufficient PBSCs were randomised to salvage ASCT ( n = 89 ) or cyclophosphamide ( n = 85 ) .
RESULTS	After a median follow-up of 31 months ( IQR 19-42 ) , median time to progression was significantly longer in the salvage ASCT than in the cyclophosphamide group ( 19 months [ 95 % CI 16-25 ] vs 11 months [ 9-12 ] ; hazard ratio 036 [ 95 % CI 025-053 ] ; p < 00001 ) .
RESULTS	Frequently reported ( in > 10 % of patients ) grade 3-4 adverse events with PAD induction , salvage ASCT , and cyclophosphamide were : neutropenia ( 125 [ 43 % ] of 293 patients after PAD , and 63 [ 76 % ] of 83 patients in the salvage ASCT group vs 11 [ 13 % ] of 84 patients in the cyclophosphamide group ) , thrombocytopenia ( 150 [ 51 % ] after PAD , and 60 [ 72 % ] vs four [ 5 % ] , respectively ) , and peripheral neuropathy ( 35 [ 12 % ] after PAD , and none vs none , respectively ) .
CONCLUSIONS	This study provides evidence for the improved efficacy of high-dose melphalan plus salvage ASCT when compared with cyclophosphamide in patients with relapsed multiple myeloma eligible for intensive therapy , which might help to guide clinical decisions regarding the management of such patients .
BACKGROUND	Cancer Research UK .

###24962856
BACKGROUND	Laparoscopic skills training has evolved over recent years .
BACKGROUND	However , conveying a mentor 's directions using conventional methods , without realistic on-screen visual cues , can be difficult and confusing .
BACKGROUND	To facilitate laparoscopic skill transference , an augmented reality telementoring ( ART ) platform was designed to overlay the instruments of a mentor onto the trainee 's laparoscopic monitor .
BACKGROUND	The aim of this study was to compare the effectiveness of this new teaching modality to traditional methods in novices performing an intracorporeal suturing task .
METHODS	Nineteen pre-medical and medical students were randomized into traditional mentoring ( n = 9 ) and ART ( n = 10 ) groups for a laparoscopic suturing and knot-tying task .
METHODS	Subjects received either traditional mentoring or ART for 1 h on the validated fundamentals of laparoscopic surgery intracorporeal suturing task .
METHODS	Tasks for suturing were recorded and scored for time and errors .
METHODS	Results were analyzed using means , standard deviation , power regression analysis , correlation coefficient , analysis of variance , and student 's t test .
RESULTS	Using Wright 's cumulative average model ( Y = aX ( b ) ) the learning curve slope was significantly steeper , demonstrating faster skill acquisition , for the ART group ( b = -0.567 , r ( 2 ) = 0.92 ) than the control group ( b = -0.453 , r ( 2 ) = 0.74 ) .
RESULTS	At the end of 10 repetitions or 1 h of practice , the ART group was faster versus traditional ( mean 167.4 vs. 242.4 s , p = 0.014 ) .
RESULTS	The ART group also had fewer fails ( 8 ) than the traditional group ( 13 ) .
CONCLUSIONS	The ART Platform may be a more effective training technique in teaching laparoscopic skills to novices compared to traditional methods .
CONCLUSIONS	ART conferred a shorter learning curve , which was more pronounced in the first 4 trials .
CONCLUSIONS	ART reduced the number of failed attempts and resulted in faster suture times by the end of the training session .
CONCLUSIONS	ART may be a more effective training tool in laparoscopic surgical training for complex tasks than traditional methods .

###25690005
OBJECTIVE	This study compared the long-term efficacy of a diabetes-specific cognitive behavioral group therapy ( CBT ) with sertraline in patients with diabetes and depression who initially responded to short-term depression treatment .
METHODS	A randomized controlled single-blind trial was conducted in 70 secondary care centers across Germany comparing 12 weeks of CBT with sertraline in 251 patients with type 1 or 2 diabetes ( mean HbA1c 9.3 % , 78 mmol/mol ) and major depression ( Structured Clinical Interview for DSM-IV [ SCID ] ) .
METHODS	After 12 weeks , treatment responders ( 50 % reduction Hamilton Depression Rating Scale [ HAMD-17 ] ) were included in the 1-year study phase where CBT patients were encouraged to use bibliotherapy and sertraline patients received continuous treatment .
METHODS	We analyzed differences for HbA1c ( primary outcome ) and reduction ( HAMD-17 ) or remission ( SCID ) of depression from baseline to the 1-year follow-up using ANCOVA or logistic regression analysis .
RESULTS	After 12 weeks , 45.8 % of patients responded to antidepressant treatment and were included in the 1-year study phase .
RESULTS	Adjusted HbA1c mean score changes from baseline to the end of the long-term phase ( -0.27 , 95 % CI -0.62 to 0.08 ) revealed no significant difference between interventions .
RESULTS	Depression improved in both groups , with a significant advantage for sertraline ( HAMD-17 change : -2.59 , 95 % CI 1.15-4 .04 , P < 0.05 ) .
CONCLUSIONS	Depression improved under CBT and sertraline in patients with diabetes and depression , with a significant advantage for sertraline , but glycemic control remained unchanged .
CONCLUSIONS	CBT and sertraline as single treatment are insufficient to treat secondary care diabetes patients with depression and poor glycemic control .

###24460808
BACKGROUND	Standing invoked change in QT interval has been identified as a promising autonomic maneuver for the assessment of QT/QTc prolongation in patients with underlying heart abnormalities or as a positive control in healthy volunteers for drug studies .
BACKGROUND	Criticism for its more widespread use is the high variability in reported results and the need for a more standardized methodology with defined normal ranges .
METHODS	Forty healthy male subjects underwent continuous ECG collection on the day before dosing in a double-blind , placebo-controlled , randomized , single ascending dose trial .
METHODS	A brisk supine to standing ( 3 minutes ) response was conducted at three time points .
METHODS	Results were grouped by treatment cohort or assessed as a pooled group at each time point .
METHODS	Maximum time and median change from baseline ( Tmax QTcF , QTcF ) were calculated for each individual over sequential 30-second periods staggered by 5 seconds .
RESULTS	Maximum QTcF at all time points and in all groups was significant ( i.e. , the lower bound of 90 % CI was > 5 milliseconds ) which is the ICH E14 regulatory requirement for a positive control .
RESULTS	Variability of the time to maximum response was also reduced 9-fold by the third time period .
CONCLUSIONS	Standing invoked QTcF can be utilized to validate the sensitivity of a study for assessment of the QT interval effect of drugs in early development .
CONCLUSIONS	The methodology may be used to further improve its diagnostic use of long QT syndromes by reducing the variability and allowing adequate definition of normal limits .

###24731891
OBJECTIVE	The purpose of this study was to explore the effect of Lavandula angustifolia ( lavender ) inhalation on the symptoms of dysmenorrhea and the amount of menstrual bleeding in female students with primary dysmenorrhea .
METHODS	This study is an experimental clinical trial .
METHODS	The subjects were 96 female students residing in dormitory at Tehran University of Medical Sciences in 2011 and suffering from level two or three dysmenorrhea according to the verbal multi-dimensional scoring system .
METHODS	The inclusion criteria were as : being single , suffering from primary dysmenorrhea , having no genital organs disorder , having no systemic disease , having regular menstrual cycles , using no contraceptives , etc. .
METHODS	The follow-up time was 4 menstrual cycles .
METHODS	The subjects were randomized into two groups : experimental ( n = 48 ) who inhaled lavender based on sesame oil , and placebo ( n = 48 ) who inhaled sesame oil only .
METHODS	The severity of dysmenorrhea symptoms was measured through a questionnaire , and the amount of menstrual bleeding was measured by sanitary towel usage .
METHODS	Ordinal logistic regression and generalized estimating equation ( GEE ) were used to analyze the data .
RESULTS	The symptoms of dysmenorrhea were significantly lowered in the lavender group compared to the placebo group ( p < 0.001 ) .
RESULTS	The amount of menstrual bleeding in the lavender group was reduced in comparison to the placebo group but the difference was not statistically significant ( p = 0.25 ) .
RESULTS	No significant difference was observed for blood clot among the students ( p = 0.666 ) .
CONCLUSIONS	This study showed that lavender inhalation was effective in alleviating dysmenorrhea symptoms , suggesting that it could be applied by midwives in a safe manner because of no side effects , simplicity and cost-effectiveness for all patients .

###24433434
OBJECTIVE	Ipilimumab is a fully human , monoclonal antibody that blocks cytotoxic T-lymphocyte antigen-4 .
OBJECTIVE	The objective of the present study was to characterize the clinical pharmacology profile of ipilimumab using a population pharmacokinetic ( PPK ) approach .
METHODS	The PPK model was developed using 2095 ipilimumab serum concentration values from 499 patients with unresectable stage III or IV melanoma from four phase II studies , with ipilimumab doses ranging from 0.3 to 10mgkg ( -1 ) .
METHODS	The structural PK model was determined by developing a base PPK model .
METHODS	The effect of covariates on model parameters was assessed by a full covariate model , which incorporated all pre-specified covariate-parameter relationships into the base model .
METHODS	The final model was developed by backward elimination , followed by exclusion of covariates determined not to be of clinical relevance to ipilimumab , and was rigorously validated against both internal and external datasets .
RESULTS	Ipilimumab PK was linear and time-invariant , with dose-proportional exposures over the available dose range , yielding a terminal half-life of approximately 15 days .
RESULTS	Clearance of ipilimumab increased with increasing body weight and baseline serum lactate dehydrogenase concentrations , but was not affected by age , gender , concomitant budesonide , Eastern Cooperative Oncology Group performance status or prior systemic anticancer therapy .
RESULTS	Furthermore , ipilimumab exposure was not affected by moderate renal impairment or mild hepatic impairment .
CONCLUSIONS	Ipilimumab concentration-time data were well described by a linear , two compartment , zero order i.v. infusion model .
CONCLUSIONS	The model confirms that a body weight-normalized dosing regimen is appropriate for ipilimumab therapy in patients with advanced melanoma .

###25048508
OBJECTIVE	Optimal analgesia in ambulatory urology patients still remains a challenge .
OBJECTIVE	The aim of this study was to examine if the pre-emptive use of intravenous tramadol can reduce pain after ureteroscopic lithotripsy in patients diagnosed with unilateral ureteral stones .
METHODS	This prospective pilot cohort study included 74 patients diagnosed with unilateral ureteral stones who underwent ureteroscopic lithotripsy under general anesthesia in the Urology Clinic at the Clinical Center of Serbia from March to June 2012 .
METHODS	All patients were randomly allocated to two groups : one group ( 38 patients ) received intravenous infusion of tramadol 100 mg in 500 mL 0.9 % NaCl one hour before the procedure , while the other group ( 36 patients ) received 500 mL 0.9 % NaCl at the same time .
METHODS	Visual analogue scale ( VAS ) scores were recorded once prior to surgery and two times after the surgery ( 1 h and 6 h , respectively ) .
METHODS	The patients were prescribed additional postoperative analgesia ( diclofenac 75 mg i.m. ) when required .
METHODS	Pre-emptive effects of tramadol were assessed measuring pain scores , VAS1 and VAS2 , intraoperative fentanyl consumption , and postoperative analgesic requirement .
RESULTS	The average VAS1 score in the tramadol group was significantly lower than that in the non-tramadol group .
RESULTS	The difference in average VAS2 score values between the two groups was not statistically significant ; however , there were more patients who experienced severe pain in the non-tramadol group ( p < 0.01 ) .
RESULTS	The number of patients that required postoperative analgesia was not statistically different between the groups .
CONCLUSIONS	Pre-emptive tramadol did reduce early postoperative pain .
CONCLUSIONS	The patients who received pre-emptive tramadol were less likely to experience severe post-operative pain .

###24402015
OBJECTIVE	To investigate the effects of exenatide on blood glucose , body weight and hepatic enzymes in patients with type 2 diabetes mellitus ( T2DM ) and concomitant non-alcoholic fatty liver disease ( NAFLD ) .
METHODS	One hundred and seventeen patients with T2DM and NAFLD were randomly divided into exenatide group and metformin group .
METHODS	Patients were treated with exenatide and metformin , respectively , for 12 weeks .
RESULTS	After 12 weeks of treatment , body weight , body mass index ( BMI ) , waist-to-hip ratio , HbA1c , FPG , 2-h PPG , ALT , AST , - GT , and hs-CRP were significantly reduced , and the AST/ALT ratio and adiponectin were markedly increased in both groups .
RESULTS	BMI , waist-to-hip ratio , 2-h PPG , ALT , AST , - GT , and hs-CRP were markedly lower , and AST/ALT ratio and adiponectin in the exenatide group were dramatically higher than in the metformin group .
CONCLUSIONS	Compared with metformin , exenatide is better to control blood glucose , reduces body weight and improves hepatic enzymes , attenuating NAFLD in patients with T2DM concomitant with NAFLD .

###24708604
BACKGROUND	Although previous studies have demonstrated that children with high levels of fundamental movement skill competency are more active throughout the day , little is known regarding children 's fundamental movement skill competency and their physical activity during key time periods of the school day ( i.e. , lunchtime , recess and after-school ) .
BACKGROUND	The purpose of this study was to examine the associations between fundamental movement skill competency and objectively measured moderate-to-vigorous physical activity ( MVPA ) throughout the school day among children attending primary schools in low-income communities .
METHODS	Eight primary schools from low-income communities and 460 children ( 8.5 0.6 years , 54 % girls ) were involved in the study .
METHODS	Children 's fundamental movement skill competency ( TGMD-2 ; 6 locomotor and 6 object-control skills ) , objectively measured physical activity ( ActiGraph GT3X and GT3X + accelerometers ) , height , weight and demographics were assessed .
METHODS	Multilevel linear mixed models were used to assess the cross-sectional associations between fundamental movement skills and MVPA .
RESULTS	After adjusting for age , sex , BMI and socio-economic status , locomotor skill competency was positively associated with total ( P = 0.002 , r = 0.15 ) and after-school ( P = 0.014 , r = 0.13 ) MVPA .
RESULTS	Object-control skill competency was positively associated with total ( P < 0.001 , r = 0.20 ) , lunchtime ( P = 0.03 , r = 0.10 ) , recess ( P = 0.006 , r = 0.11 ) and after-school ( P = 0.022 , r = 0.13 ) MVPA .
CONCLUSIONS	Object-control skill competency appears to be a better predictor of children 's MVPA during school-based physical activity opportunities than locomotor skill competency .
CONCLUSIONS	Improving fundamental movement skill competency , particularly object-control skills , may contribute to increased levels of children 's MVPA throughout the day .
BACKGROUND	Australian New Zealand Clinical Trials Registry No : ACTRN12611001080910 .

###25351016
BACKGROUND	Low back pain ( LBP ) is chronic disease without a curative therapy .
BACKGROUND	Alternative and complementary therapies are widely used in the management of this condition .
OBJECTIVE	To evaluate the efficacy of home application of Dead Sea mud compresses to the back of patients with chronic LBP .
METHODS	Forty-six consecutive patients suffering from chronic LBP were recruited .
METHODS	All patients were followed at the Soroka University Rheumatic Diseases Unit .
METHODS	The patients were randomized into two groups : one group was treated with mineral-rich mud compresses , and the other with mineral-depleted compresses .
METHODS	Mud compresses were applied five times a week for 3 consecutive weeks .
METHODS	The primary outcome was the patient 's assessment of the overall back pain severity .
METHODS	The score of the Ronald & Morris questionnaire served as a secondary outcome .
RESULTS	Forty-four patients completed the therapy and the follow-up assessments : 32 were treated with real mud packs and 12 used the mineral-depleted packs .
RESULTS	A significant decrease in intensity of pain , as described by the patients , was observed only in the treatment group .
RESULTS	In this group , clinical improvement was clearly seen at completion of therapy and was sustained a month later .
RESULTS	Significant improvement in the scores of the Roland & Morris questionnaire was observed in both groups .
CONCLUSIONS	The data suggest that pain severity was reduced in patients treated with mineral-rich mud compresses compared with those treated with mineral-depleted compresses .
CONCLUSIONS	Whether this modest effect is the result of a `` true '' mud effect or other causes can not be determined in this study .

###25278714
OBJECTIVE	To compare magnetic imaging-assisted colonoscopy ( MIC ) with conventional colonoscopy ( CC ) .
METHODS	Magnetic imaging technology provides a computer-generated image of the shape and position of the colonoscope onto a monitor to give visual guidance to the endoscopist .
METHODS	It is designed to improve colonoscopy performance and tolerability for patients by enabling visualization of loop formation and endoscope position .
METHODS	Recently , a new version of MIC technology was developed for which there are limited data.To evaluate this latest generation of MIC among experienced rather than inexperienced or trainee endoscopists , a prospective randomized trial was performed using only gastroenterologists with therapeutic endoscopy training .
METHODS	Consecutive patients undergoing elective outpatient colonoscopy were randomized to MIC or CC , with patients blinded to their group assignment .
METHODS	Endoscopic procedural metrics and quantities of conscious sedation medications were recorded during the procedures .
METHODS	The procedure was classified as `` usual '' or `` difficult '' by the endoscopist at the conclusion of each case based on the need for adjunctive maneuvers to facilitate endoscope advancement .
METHODS	After more than one hour post-procedure , patients completed a 10 cm visual analogue pain scale to reflect the degree of discomfort experienced during their colonoscopy .
METHODS	The primary outcome was patient comfort expressed by the visual analogue pain score .
METHODS	Secondary outcomes consisted of endoscopic procedural metrics as well as a sedation score derived from standardized dose increments of the conscious sedation medications .
RESULTS	Two hundred fifty-three patients were randomized and underwent MIC or CC between September 2011 and October 2012 .
RESULTS	The groups were similar in terms of the indications for colonoscopy and patient characteristics .
RESULTS	There were no differences in cecal intubation rates ( 100 % vs 99 % ) , insertion distance-to-cecum ( 82 cm vs 83 cm ) , time-to-cecum ( 6.5 min vs 7.2 min ) , or polyp detection rate ( 47 % vs 52 % ) between the MIC and CC groups .
RESULTS	The primary outcome of mean pain score ( 1.0 vs 0.9 out of 10 , P = 0.41 ) did not differ between MIC and CC groups , nor did the mean sedation score ( 8.2 vs 8.5 , P = 0.34 ) .
RESULTS	Within the subgroup of cases considered more challenging or difficult , time-to-cecum was significantly faster with MIC compared to CC , 10.1 min vs 13.4 min respectively ( P = 0.01 ) .
RESULTS	Sensitivity analyses confirmed a similar pattern of overall findings when each endoscopist was considered separately , demonstrating that the mean results for the entire group were not unduly influenced by outlier results from any one endoscopist .
CONCLUSIONS	Although the latest version of MIC resulted in faster times-to-cecum within a subgroup of more challenging cases , overall it was no better than CC in terms of patient comfort , sedation requirements and endoscopic procedural metrics , when performed in experienced hands .

###25023784
BACKGROUND	Iron deficiency is one of the most common nutritional deficiencies worldwide .
BACKGROUND	It is more prevalent when iron requirements are increased during pregnancy and during growth spurts of infancy and adolescence .
BACKGROUND	The last stage in the process of iron depletion is characterized by a decrease in hemoglobin concentration , resulting in iron deficiency anemia .
BACKGROUND	Iron deficiency , even before it is clinically identified as anemia , compromises the immune response , physical capacity for work , and intellectual functions such as attention level .
BACKGROUND	Therefore , interventions addressing iron deficiency should be based on prevention rather than on treatment of anemia .
BACKGROUND	The aim of this study was to compare short - and medium-term effects on ferritin concentration of daily supplementation with ferrous sulfate or iron bis-glycinate chelate in schoolchildren with iron deficiency but without anemia .
METHODS	Two hundred schoolchildren from public boarding schools in Mexico City who had low iron stores as assessed by serum ferritin concentration but without anemia were randomly assigned to a daily supplement of 30mg/day of elemental iron as ferrous sulfate or iron bis-glycinate chelate for 12weeks .
METHODS	Iron status was evaluated at baseline , one week post-supplementation ( short term ) , and 6months ( medium term ) after supplementation .
RESULTS	Ferritin concentration increased significantly between baseline and post-supplementation as well as between baseline and 6months after supplementation .
RESULTS	One week post-supplementation no difference was found in ferritin concentration between iron compounds , but 6months after supplementation ferritin concentration was higher in the group that received bis-glycinate chelate iron .
RESULTS	However , there is no difference in the odds for low iron storage between 6months after supplementation versus the odds after supplementation ; nor were these odds different by type of supplement .
RESULTS	Hemoglobin concentration did not change significantly in either group after supplementation .
CONCLUSIONS	Supplementing with 30mg/d of elementary iron , either as ferrous sulfate or iron bis-glycinate chelate for 90days , showed positive effects on increasing ferritin concentration in schoolchildren with low iron stores , and this effect persisted 6months after supplementation .

###25509696
BACKGROUND	Postoperative parathyroidectomy hypocalcemia probably results from acute reversal of the parathyroid hormone induced contribution of bone to maintain serum calcium concentration .
OBJECTIVE	Compare the effective treatment of calcitriol regimens ( loaded and titrated ) in control hypocalcemic hyperparathyroid ( HPT ) patients who were referred for parathyroidectomy .
METHODS	A randomized control , open labeled study of 25 patients who underwent parathyroidectomy in Rajavithi Hospital from August 2009 to September 2010 was conducted .
METHODS	The authors randomized 25 patients with chronic kidney disease in two treatment arms of calcitriol ( A : Titrated dose regimen , B : Loaded dose regimen ) , that met criteria .
METHODS	Biochemical factors available within 2 weeks before and after surgery were recorded and analyzed .
RESULTS	No significant difference was observed in amount of calcium gluconate intravenous use , hypocalcemia and hospital admission durations between titrated and loaded regimen groups , i.e. , p = 0.160 , 0.645 and 0.460 , respectively .
RESULTS	Loaded regimen ameliorated the mean reduction of day 7 postoperative mean change of serum calcium level by 0.330.99 mg/dl and median change by 2.88 mg/dl ( min , max = -0.80 , 5.64 ) compared with titrate regimen mean change ofserum calcium level by 2.682.16 mg/dl ; median change 0.28 mg/dl ( min , max = -0.84 , 1.80 ) with significance , p = 0.036 .
CONCLUSIONS	Loaded calcitriol regimen was superior to titrated calcitriol regimen compared with the control group the first 7 days postparathyroidectomy .
CONCLUSIONS	Amount of calcium gluconate intravenous used , hypocalcemia and duration of hospital stay did not show any significance .

###25338443
OBJECTIVE	To discuss the curative effect of traditional treatment and combination therapy for senile hip fracture .
METHODS	Using prospective methods to choose 300 cases of elderly patients with hip fractures from February 2011 to December 2012 , which were randomly divided into comprehensive treatment group and conventional treatment group .
METHODS	After screening , 148 case were in comprehensive treatment group , including 62 males and 86 females with an average age of ( 78.76 + / - 7.32 ) years old ranging from 60 to 88 ; 45 cases were intertrochanteric fracture of femur , 103 cases were fracture of neck of femur ; Singh index > or = IV in 74 cases , < IV in 74 cases ; preoperative Harris score was 39.90 + / - 2.28 .
METHODS	There were 146 cases in conventional treatment group , including 60 males and 86 females with an average age of ( 80.00 + / - 7.06 ) years old ranging from 66 to 96 ; 50 cases were intertrochanteric fracture of femur , 96 cases were fracture of neck of femur ; Singh index > or = IV in 75 cases , < IV in 71 cases ; preoperative Harris score was 40.10 + / - 2.81 .
METHODS	Preoperative general situation , leaving bed time and hospital stay , the incidence of postoperative 12 weeks Singh index > or = IV and DPD/Cr value , Harris score at 12 months after operation and the incidence of fracture again of two groups were observed and compared .
RESULTS	In comprehensive treatment group 140 patients were followed up for 12 to 18 months with an anverage of 14.80 + / - 1.85 .
RESULTS	In conventional treatment group 132 patients were followed up for 12 to 14 months with an average of 12.75 + / - 0.79 .
RESULTS	There were no significant differences in age , gender , the classification of fracture , preoperative Harris hip score , preoperative Singh index > or = IV level and DPD/Cr value between the two groups ( P > 0.05 ) .
RESULTS	Comprehensive treatment group had shorter leaving bed time and hospital stay , smaller postoperative 12 weeks DPD/Cr value and higher postoperative Harris score , higher incidence of postoperative 12 weeks Singh index > or = IV level , lower incidence of fracture again than conventional treatment group , there was statistically significant difference between two groups ( P < 0.05 ) .
CONCLUSIONS	For the anti-osteoporosis effect , the comprehensive treatment group has more advantage than traditional treatment group in elderly hip fracture , which can further improve the elderly hip fracture treatment and provide the reference of evidence-based medicine cooperate with rehabilitation department .

###24571189
OBJECTIVE	To assess the role of toothbrushing self-efficacy ( TBSE ) in diabetes management by comparing health education ( HE ) and health coaching ( HC ) in type 2 diabetes .
METHODS	The data [ HbA1c , Clinical Attachment Loss ( CAL ) , TBSE ] were collected initially and after intervention .
METHODS	Participants were allocated randomly to HC ( n = 77 ) and HE ( n = 109 ) groups .
RESULTS	The low TBSE subgroup showed greater improvement in TBSE in the HC group ( mean :23.49.2 ) than the HE group ( mean :12.410.3 ) , ( P < 0.01 ) .
RESULTS	The moderate TBSE group showed significant improvements only in the HC group ( P < 0.001 ) .
RESULTS	There was a significant reduction in HbA1c and CAL in all the TBSE subgroups in HC ( P < 0.05 ) , which was significantly higher than in the HE groups ( P < 0.05 ) .
RESULTS	Improvements in TBSE and CAL were explanatory variables for the reduction in HbA1c among the HC patients in all the TBSE subgroups ( P < 0.05 ) .
RESULTS	Among HE patients , improvement in CAL was an explanatory variable for change at HbA1c in the low TBSE subgroup .
CONCLUSIONS	The present findings show that HC is more effective in terms of reduced HbA1c and CAL compared with HE .
CONCLUSIONS	The data suggest that HC unlocks positive self-intrinsic motivation , anchoring the self-efficacy/competency beliefs for adjustment of healthy lifestyles .
CONCLUSIONS	Thus , TBSE may be a practical starting point for empowerment and more effective outcomes .

###24391142
OBJECTIVE	To investigate the efficacy and safety of telmisartan 80mg/amlodipine 5mg ( T80/A5 ) single-pill combination versus A5 in patients with essential hypertension not adequately controlled on A5 monotherapy .
METHODS	Asian patients 18 years old , with inadequately controlled blood pressure ( BP ) at enrolment , who failed to achieve a seated diastolic BP ( DBP ) goal ( 90mmHg ) following 6-weeks ' open-label A5 treatment , were randomly allocated 1:1 to 8 weeks ' double-blind treatment with T80/A5 single-pill combination or A5 .
RESULTS	A total of 324 patients entered the double-blind treatment phase .
RESULTS	The adjusted meanSE reduction in seated trough DBP from baseline to week 8 was significantly greater with T80/A5 ( 12.41.0 mmHg ) than A5 ( 10.20.9 mmHg [ primary endpoint , n = 314 ] ) .
RESULTS	Results were similar in the subset of 262 Chinese patients .
RESULTS	Treatment-related adverse events were 1.9 % with T80/A5 and 2.4 % with A5 .
CONCLUSIONS	In Asian patients with hypertension , T80/A5 single-pill combination provided improved BP reduction after 8 weeks ' treatment compared with A5 monotherapy .
CONCLUSIONS	Both treatments were well tolerated .

###24338901
OBJECTIVE	A new acquisition scheme for T2-weighted spin-echo BOLD fMRI is introduced .
METHODS	It uses a T2-preparation module to induce blood-oxygenation-level-dependent ( BOLD ) contrast , followed by a single-shot three-dimensional ( 3D ) fast gradient-echo readout with short echo time ( TE ) .
METHODS	It differs from most spin-echo BOLD sequences in that BOLD contrast is generated before the readout , which eliminates the `` dead time '' due to long TE required for T2 contrast , and substantially improves acquisition efficiency .
METHODS	This approach , termed `` 3D T2prep-GRE , '' was implemented at 7 Tesla ( T ) with a typical spatial ( 2.52.52.5 mm ( 3 ) ) and temporal ( TR = 2.3 s ) resolution for functional MRI ( fMRI ) and whole-brain coverage ( 55 slices ) , and compared with the widely used 2D spin-echo EPI sequence .
RESULTS	In fMRI experiments of simultaneous visual/motor activities , 3D T2prep-GRE showed minimal distortion and little signal dropout across the whole brain .
RESULTS	Its lower power deposition allowed greater spatial coverage ( 55 versus 17 slices with identical TR , resolution and power level ) , temporal SNR ( 60 % higher ) and CNR ( 35 % higher ) efficiency than 2D spin-echo EPI .
RESULTS	It also showed smaller T2 * contamination .
CONCLUSIONS	This approach is expected to be useful for ultra-high field fMRI , especially for regions near air cavities .
CONCLUSIONS	The concept of using T2-preparation to generate BOLD contrast can be combined with many other sequences at any field strength .

###25197669
BACKGROUND	Poor response to ovarian stimulation is still a major problem in IVF .
BACKGROUND	The study presents a new stimulation protocol evaluated in a suppopulation of very difficult young poor ovarian responders .
METHODS	The study consists in two sections .
METHODS	The first includes data from a randomized controlled study involving forty-three young patients with a poor ovarian response in at least two previous cycles ( intended as cycle cancellation or with 3 collected oocytes ) .
METHODS	Patients were randomized in two groups : group A ( control ) received FSH ( 400IU/day ) , while group B received the new stimulation protocol consisting in a sequential association of 150IU r-LH for 4 days followed by 400IU r-FSH/after downregulation with daily GnRh agonist .
METHODS	The second includes data from the overall results in 65 patients treated with the new protocol compared to their previous performance with conventional cycles ( historical control ) .
RESULTS	Both in the RCT and in the historical control study , LH pretreatment was able to decrease the cancellation rate , to improve the in vitro performance , and to significantly increase the live birth rates .
CONCLUSIONS	LH pretreatment improved oocyte quantity and quality in young repeated poor responders selected in accordance with the Bologna criteria .

###24823426
BACKGROUND	Procedural and clinical outcomes still remain unfavorable for patients with long coronary lesions who undergo percutaneous coronary intervention .
BACKGROUND	The current study , therefore , evaluated 2 innovative drug-eluting stents for the management of long-lesion coronary artery disease .
RESULTS	This randomized , multicenter , prospective trial , called the Long Drug-Eluting Stent ( LONG-DES ) V trial , compared the biodegradable polymer-based biolimus A9-eluting stent ( BES ) and the durable polymer-based platinum chromium everolimus-eluting stent ( PtCr-EES ) in 500 patients with long ( 25 mm ) coronary lesions .
RESULTS	The primary end point of the trial was in-segment late luminal loss at the 9-month angiographic follow-up .
RESULTS	The BES and PtCr-EES groups had similar baseline characteristics , with a slightly shorter lesion length in the BES group versus the PtCr-EES group ( 29.24 12.17 versus 32.27 13.84 mm ; P = 0.016 ) .
RESULTS	In-segment late luminal loss was comparable between the 2 groups at the 9-month angiographic follow-up ( BES , 0.14 0.38 versus PtCr-EES , 0.11 0.37 mm ; difference , 0.031 ; 95 % confidence interval , -0.053 to 0.091 ; P = 0.03 for a noninferiority margin of 0.11 , P = 0.45 for superiority ) , as was in-stent late luminal loss ( 0.20 0.41 versus 0.24 0.38 mm ; P = 0.29 ) .
RESULTS	The incidence of in-segment ( 6.1 % versus 4.9 % ; P = 0.63 ) and in-stent ( 3.7 % versus 4.9 % ; P = 0.59 ) binary restenosis was also similar between the groups .
RESULTS	There was no significant between-group difference in the rate of composite outcome of death , myocardial infarction , and target vessel revascularization ( 41 , 16.7 % in BES versus 42 , 16.5 % in PtCr-EES ; P = 0.94 ) .
CONCLUSIONS	BES and PtCr-EES implantation showed analogous angiographic and clinical outcomes for patients with de novo long coronary lesions .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01186120 .

###24502839
OBJECTIVE	To examine whether use of functional capacity evaluation ( FCE ) leads to better outcomes for injured workers .
METHODS	Cluster randomized controlled trial conducted with analysis at level of claimant .
METHODS	Rehabilitation facility .
METHODS	Participants included claimants ( N = 203 ) ; of these , 103 were tested with FCE .
METHODS	Data were collected on all claimants undergoing RTW assessment at the facility for musculoskeletal conditions .
METHODS	Participants were predominantly employed ( 59 % ) men ( 73 % ) with chronic musculoskeletal conditions ( median duration , 496d ) .
METHODS	FCEs are commonly used to identify work abilities and inform return-to-work ( RTW ) decisions .
METHODS	Therefore , FCE results have important consequences .
METHODS	Clinicians who were trained and experienced in performing FCEs were randomized into 2 groups .
METHODS	One group included 14 clinicians who were trained to conduct a semistructured functional interview ; the other group ( control group ) continued to use standard FCE procedures .
METHODS	Outcomes included RTW recommendations after assessment , functional work level at time of assessment and 1 , 3 , and 6 months after assessment , and compensation outcomes .
METHODS	Analysis included Mann-Whitney U , chi-square , and t tests .
RESULTS	All outcomes were similar between groups , and no statistically or clinically significant differences were observed .
RESULTS	Mean differences between groups on functional work levels at assessment and follow-up ranged from 0.1 to 0.3 out of 4 ( 3 % -8 % difference , P > .05 ) .
CONCLUSIONS	Performance-based FCEs did not appear to enhance RTW outcomes beyond information gained from semistructured functional interviewing .
CONCLUSIONS	Use of functional interviewing has the potential to improve efficiency of RTW assessment without compromising clinical , RTW , or compensation outcomes .

###25159343
BACKGROUND	Tension pneumothorax can rapidly progress to cardiac arrest and death if not promptly recognized and appropriately treated .
BACKGROUND	We sought to evaluate the effectiveness of traditional didactic slide-based lectures ( SBLs ) as compared with fresh tissue cadaver-based training ( CBT ) for placement of needle thoracostomy ( NT ) .
METHODS	Forty randomly selected US Navy corpsmen were recruited to participate from incoming classes of the Navy Trauma Training Center at the LAC + USC Medical Center and were then randomized to one of two NT teaching methods .
METHODS	The following outcomes were compared between the two study arms : ( 1 ) time required to perform the procedure , ( 2 ) correct placement of the needle , and ( 3 ) magnitude of deviation from the correct position .
RESULTS	During the study period , a total of 40 corpsmen were enrolled , 20 randomized to SBL and 20 to CBT arms .
RESULTS	When outcomes were analyzed , time required to NT placement was not different between the two arms .
RESULTS	Examination of the location of needle placement revealed marked differences between the two study groups .
RESULTS	Only a minority of the SBL group ( 35 % ) placed the NT correctly in the second intercostal space .
RESULTS	In comparison , the majority of corpsmen assigned to the CBT group demonstrated accurate placement in the second intercostal space ( 75 % ) .
CONCLUSIONS	In a CBT module , US Navy corpsmen were better trained to place NT accurately than their traditional didactic SBL counterparts .
CONCLUSIONS	Further studies are indicated to identify the optimal components of effective simulation training for NT and other emergent interventions .

###24572077
BACKGROUND	Follicular lymphoma has been shown to be highly radiosensitive with responses to doses as low as 4 Gy in two fractions .
BACKGROUND	This trial was designed to explore the dose response for follicular lymphoma comparing 4 Gy in two fractions with 24 Gy in 12 fractions
METHODS	FORT is a prospective randomised , unblinded , phase 3 non-inferiority study comparing radiotherapy given as 4 Gy in two fractions with a standard dose of 24 Gy in 12 fractions .
METHODS	Entry criteria included all patients aged over 18 years , having local radiotherapy for radical or palliative local control , with follicular lymphoma or marginal zone lymphoma , who had received no previous treatment for at least 1 month before .
METHODS	The primary outcome was time to local progression analysed on an intention-to-treat basis .
METHODS	Randomisation was centralised through the Cancer Research UK and University College London Cancer Trials Centre .
METHODS	Radiotherapy target sites were randomised ( 1:1 ) with minimisation stratified by histology ( follicular lymphoma vs marginal zone lymphoma ) , treatment intent ( palliative or curative ) and centre .
METHODS	This trial is registered with ClinicalTrials.gov number , NCT00310167 .
RESULTS	299 sites were randomly assigned to 24 Gy and 315 sites to 4 Gy between April 7 , 2006 , and June 8 , 2011 , at 43 centres in the UK .
RESULTS	After a median follow-up of 26 months ( range 039-754 ) , 91 local progressions had been recorded ( 21 in the 24 Gy group and 70 in the 4 Gy group ) .
RESULTS	Time to local progression with 4 Gy was not non-inferior to 24 Gy ( hazard ratio 342 , 95 % CI 209-555 , p < 00001 ) .
RESULTS	Eight ( 3 % ) of 282 patients in the 24 Gy group and four ( 1 % ) of 300 in the 4 Gy group had acute grade 3-4 toxic effects .
RESULTS	Four ( 1 % ) patients in the 24 Gy group and four ( 1 % ) patients in the 4 Gy group had late toxic effects .
RESULTS	Mucositis was the most common event in the 24 Gy group ( two patients with acute mucositis and two with late mucositis ; all grade 3 ) and was not reported in the 4 Gy group .
RESULTS	The most common acute effect was pain at the site of irradiation ( two patients in the 4 Gy group , one patient in the 24 Gy group ; all grade 3 ) , and the most common late effect was fatigue ( two patients in the 4 Gy group , one patient in the 24 Gy group ; all grade 3 ) .
CONCLUSIONS	24 Gy in 12 fractions is the more effective radiation schedule for indolent lymphoma and should be regarded as the standard of care .
CONCLUSIONS	However , 4 Gy remains a useful alternative for palliative treatment .
BACKGROUND	Cancer Research UK .

###25052821
OBJECTIVE	Single-ventricle patients undergoing pediatric heart surgery are a high-risk group owing to reoxygenation injury during cardiopulmonary bypass ( CPB ) .
OBJECTIVE	The present study investigated the effects of controlled reoxygenation CPB on biomarkers of organ damage , inflammation , stress , and long-term functional outcomes in cyanotic patients with either a single or double ventricle during open heart surgery .
METHODS	Cyanotic patients with either a single ( n = 32 ) or double ( n = 47 ) ventricle undergoing surgical correction were randomized to receive CPB using either standard oxygen levels or controlled reoxygenation .
METHODS	The markers of cardiac injury , inflammation , stress , and cerebral and hepatic injury were measured preoperatively , at 10 and 30 minutes after starting CPB , and at 10 minutes and 4 and 24 hours after CPB .
METHODS	The data were analyzed using a mixed regression model .
RESULTS	No difference was found in the pre - or intraoperative characteristics between the standard and controlled reoxygenation CPB groups for single - or double-ventricle patients .
RESULTS	In the single-ventricle patients , controlled reoxygenation CPB significantly ( P < .05 ) decreased the markers of organ damage , inflammation , stress , and oxidative stress .
RESULTS	In contrast , the markers of inflammation and cardiac injury were not altered by controlled reoxygenation CPB in the double-ventricle patients .
CONCLUSIONS	Controlled reoxygenation CPB decreased the markers of organ damage , stress , inflammation , and oxidative stress in single-ventricle patients undergoing cardiac surgery .

###25123988
BACKGROUND	Testosterone 2 % solution is applied to axillae and is indicated for testosterone replacement therapy in males deficient in endogenous testosterone .
OBJECTIVE	This open-label crossover study evaluated the effect of deodorant/antiperspirant use and presence or absence of axillary hair on absorption of testosterone solution .
METHODS	Healthy males ( N = 30 ; 50 years of age with baseline testosterone < 400ng/dL ) were randomized to one of four treatment sequences involving six treatments .
METHODS	Each treatment consisted of one 1.5-mL dose of testosterone 2 % solution ( 30mg of testosterone ) applied to each axilla .
METHODS	Axillae were unshaved or shaved , and were untreated or pretreated with deodorant/antiperspirant .
METHODS	Blood samples were taken over 72 hours after each dose for measuring serum testosterone concentrations .
RESULTS	Profiles of mean testosterone concentrations were similar across treatments .
RESULTS	For all treatments , area under the concentration-time curve through 24 hours ( AUC [ 0-24 ] ) and 72 hours ( AUC [ 0-72 ] ) , and maximum total testosterone concentration ( Cmax ) were similar except for 15 % lower Cmax when treatment was applied after deodorant/antiperspirant to shaved vs. unshaved axillae ( least squares mean , 531ng/dL vs. 626ng/dL , respectively ; P = 0.011 ) .
RESULTS	This difference is not considered clinically significant .
RESULTS	The 95 % confidence intervals for AUC ( 0-24 ) , AUC ( 0-72 ) , and Cmax fell within the traditional bioequivalence limits of 0.8 to 1.25 .
RESULTS	Incidence of treatment-emergent adverse events ( TEAEs ) was low ( < 15 % ) in each treatment arm , and most TEAEs were mild .
CONCLUSIONS	Absorption of testosterone 2 % solution was unaffected by use of deodorant/antiperspirant or by the presence or absence of axillary hair .
CONCLUSIONS	Testosterone solution was generally well tolerated .

###26054202
OBJECTIVE	To observe the effect of electroacupuncture ( EA ) treatment on the quality of ovum , stem cell factor ( SCF ) and the pregnancy outcome in patients with polycystic ovarian syndrome ( PCOS ) , so as to explore its mechanism underlying improving pregnancy rate .
METHODS	A total of 200 PCOS patients undergoing in vitro fertilization-embryo transplantation ( IVF-ET ) were randomly divided into control ( medication ) group ( n = 98 ) and EA group ( n = 102 ) .
METHODS	For patients of the EA group who were undergoing controlled ovarian hyperstimulation , EA stimulation ( 5 Hz/20 Hz , 15-20 V ) was applied to bilateral Shenshu ( BL 23 ) , Qihai ( CV6 ) , bilateral Zusanli ( ST 36 ) - Sanyinjiao ( SP 6 ) , and bilateral Neiguan ( PC6 ) - Zigong ( EX-CA 1 ) for 30 min , once daily till accepting embryo transplant .
METHODS	Patients of the medication group were treated with controlled ovarian hyperstimulation using Diane-35 , Decepepty , Gonadotrophin , human Chorionic Gonadotrophin , etc. .
METHODS	Serum follicle-stimulating hormone ( FSH ) , luteinizing hormone ( LH ) , testosterone ( T ) , estradiol ( E2 , and progesterone ( P ) contents were detected using chemiluminescent method .
METHODS	SCF contents in the serum and follicular fluid were assayed by ELISA .
METHODS	The number of retrieved oocytes , fertilization rate , cleavage rate , high quality embryo rate , ovarian hyperstimulation syndrome ( OHSS ) incidence rate , cycle cancellation rate , clinical pregnancy rate , early abortion rate , Gn dosage and administration duration , and the correlation between the high quality embryo rate and SOF level were determined .
RESULTS	Comparison between the two groups showed that the high quality embryo rate , and serum and follicular fluid SCF contents were significantly higher in the EA group than in the medication group ( P < 0.05 , P < 0.01 ) , while the dosage and administration duration of Gn were significantly lower in the EA group than in the medication group ( P < 0.05 ) .
RESULTS	A positive correlation was found between the high quality embryo rate and the SCF level in both follicular fluid and serum ( P < 0.01 ) .
RESULTS	No significant differences were found between the two groups in the number of retrieved oocytes , fertilization rate , cleavage rate , clinical pregnancy rate , OHSS incidence rate , cycle cancellation rate , early abortion rate , serum LH , E2 and P contents ( P > 0.05 ) .
CONCLUSIONS	EA can improve the high quality embryo rate , which may be related to its effect in increasing serum and follicular fluid SCF levels .

###24583541
OBJECTIVE	To examine the post-exercise cross-transfer effects of acute whole body vibration ( WBV ) .
METHODS	Seventeen healthy male volunteers ( 20.8 1.2 y ) performed three unilateral vibration conditions in a randomized order : 1 ) WBV-50 Hz [ high amplitude ] ; 2 ) WBV-30 Hz [ low amplitude ] ; and 3 ) a control no WBV condition ( Sham ) applied to the dominant leg .
METHODS	Each condition involved maximal voluntary isometric contractions ( MVC ) followed by three leg press explosive repetitions ( 40 % MVC ) with non-dominant and dominant legs ; which were conducted prior to and post vibration ( immediately ; 2 min and 5 min ) .
METHODS	Surface electromygraphy ( sEMG ) of the vastus lateralis ( VL ) and medial gastrocnemius ( MG ) were measured throughout each condition .
RESULTS	A condition x leg x time interaction effect was detected ( p = 0.001 ) where 50 Hz-High in the stimulated leg enhanced mean velocity at post-2 min compared to 30 Hz-Low and Sham , remaining elevated at post-5 min .
RESULTS	Similarly , 50 Hz-High in the non-stimulated leg increased mean velocity at post-immediately and post-2 min compared to 30 Hz-Low and Sham .
RESULTS	There were no changes in sEMG of VL and GM in the stimulated and non-stimulated post-conditions .
CONCLUSIONS	WBV ( 50 Hz ) can augment cross-transfer in neuromuscular performance .
CONCLUSIONS	WBV could provide an alternate method of unilateral training to promote cross education explosive strength .

###25085020
OBJECTIVE	To assess the effectiveness of fennel on primary dysmenorrhea symptoms and menorrheal duration .
METHODS	Clinical trial study .
METHODS	Islamic Azad University , Toyserkan .
METHODS	80 female students were randomly divided in to two groups of intervention ( n = 40 ) and control ( n = 40 ) .
METHODS	The intervention group was given one soft capsule Fennel ( 30 mg ) every 4 hours , 3 days before menstruation till the 5th day and continued for 3 months .
METHODS	The control group received no medication .
METHODS	The severity of samples pain was graded using a visual analogue scale .
METHODS	5 standard questionnaires include of Visual analog scale pain ( VAS ) , McGill pain questionnaire , the range of stress about dysmenorrheal ( VASA ) , Perceived stress scale , Well being scale were filled out in intervals of before , during and after fennel capsule uptake .
METHODS	Data were analyzed by SPSS 17 software .
METHODS	P < .05 was considered to be statistically significant .
RESULTS	The mean of nausea intensity and weakness decreased to 1.93 , and 2.88 after 3 months , whereas they were 2.37 , 6.65 in control group which indicated a significant difference .
RESULTS	Reduce the duration of menstrual period , a significant difference was found after two and three months of use .
RESULTS	Concern in terms of quality and feelings of well-being after 1 and 3 months , was observed significant difference compared with before using .
CONCLUSIONS	Considering the safety of herbal medicines , this drug can use to relieve dysmenorrheal signs and menstrual duration .

###25649214
BACKGROUND	Vascular access devices ( VADs ) , such as peripheral or central venous catheters , are vital across all medical and surgical specialties .
BACKGROUND	To allow therapy or haemodynamic monitoring , VADs frequently require administration sets ( AS ) composed of infusion tubing , fluid containers , pressure-monitoring transducers and/or burettes .
BACKGROUND	While VADs are replaced only when necessary , AS are routinely replaced every 3-4days in the belief that this reduces infectious complications .
BACKGROUND	Strong evidence supports AS use up to 4days , but there is less evidence for AS use beyond 4days .
BACKGROUND	AS replacement twice weekly increases hospital costs and workload .
METHODS	This is a pragmatic , multicentre , randomised controlled trial ( RCT ) of equivalence design comparing AS replacement at 4 ( control ) versus 7 ( experimental ) days .
METHODS	Randomisation is stratified by site and device , centrally allocated and concealed until enrolment .
METHODS	6554 adult/paediatric patients with a central venous catheter , peripherally inserted central catheter or peripheral arterial catheter will be enrolled over 4years .
METHODS	The primary outcome is VAD-related bloodstream infection ( BSI ) and secondary outcomes are VAD colonisation , AS colonisation , all-cause BSI , all-cause mortality , number of AS per patient , VAD time in situ and costs .
METHODS	Relative incidence rates of VAD-BSI per 100 devices and hazard rates per 1000 device days ( 95 % CIs ) will summarise the impact of 7-day relative to 4-day AS use and test equivalence .
METHODS	Kaplan-Meier survival curves ( with log rank Mantel-Cox test ) will compare VAD-BSI over time .
METHODS	Appropriate parametric or non-parametric techniques will be used to compare secondary end points .
METHODS	p Values of < 0.05 will be considered significant .
BACKGROUND	Relevant ethical approvals have been received .
BACKGROUND	CONSORT Statement recommendations will be used to guide preparation of any publication .
BACKGROUND	Results will be presented at relevant conferences and sent to the major organisations with clinical practice guidelines for VAD care .
BACKGROUND	Australian New Zealand Clinical Trial Registry ( ACTRN 12610000505000 ) .

###24438517
BACKGROUND	Applying mobile phones in healthcare is increasingly prioritized to strengthen healthcare systems .
BACKGROUND	Antenatal care has the potential to reduce maternal morbidity and improve newborns ' survival but this benefit may not be realized in sub-Saharan Africa where the attendance and quality of care is declining .
BACKGROUND	We evaluated the association between a mobile phone intervention and antenatal care in a resource-limited setting .
BACKGROUND	We aimed to assess antenatal care in a comprehensive way taking into consideration utilisation of antenatal care as well as content and timing of interventions during pregnancy .
METHODS	This study was an open label pragmatic cluster-randomised controlled trial with primary healthcare facilities in Zanzibar as the unit of randomisation .
METHODS	2550 pregnant women ( 1311 interventions and 1239 controls ) who attended antenatal care at selected primary healthcare facilities were included at their first antenatal care visit and followed until 42 days after delivery .
METHODS	24 primary health care facilities in six districts were randomized to either mobile phone intervention or standard care .
METHODS	The intervention consisted of a mobile phone text-message and voucher component .
METHODS	Primary outcome measure was four or more antenatal care visits during pregnancy .
METHODS	Secondary outcome measures were tetanus vaccination , preventive treatment for malaria , gestational age at last antenatal care visit , and antepartum referral .
RESULTS	The mobile phone intervention was associated with an increase in antenatal care attendance .
RESULTS	In the intervention group 44 % of the women received four or more antenatal care visits versus 31 % in the control group ( OR , 2.39 ; 95 % CI , 1.03-5 .55 ) .
RESULTS	There was a trend towards improved timing and quality of antenatal care services across all secondary outcome measures although not statistically significant .
CONCLUSIONS	The wired mothers ' mobile phone intervention significantly increased the proportion of women receiving the recommended four antenatal care visits during pregnancy and there was a trend towards improved quality of care with more women receiving preventive health services , more women attending antenatal care late in pregnancy and more women with antepartum complications identified and referred .
CONCLUSIONS	Mobile phone applications may contribute towards improved maternal and newborn health and should be considered by policy makers in resource-limited settings .

###26062189
OBJECTIVE	To compare the differences in pain reaction , hemodynamics and clinical efficacy between extracorporeal shock wave lithotripsy ( ESWL ) after injection with flurphen mixture ( mixture of droperidol and fentanyl citrate ) at Shenshu ( BL 23 ) and simple ESWL in the patients .
METHODS	Sixty-four cases of urinary calculi with ESWL were randomized into an observation group and a control group , 32 cases in each one .
METHODS	In the observation group , 15 to 20 min before ESWL , flurphen mixture ( droperidol injection 1.25 mg and fentanyl citrate injection 0.05 mg were diluted to 6 mL with 0.9 % sodium chloride solution 4.5 mL ) was injected at bilateral Shenshu ( BL 23 ) .
METHODS	In the control group , no any adjuvant therapy and medication were used before ESWL .
METHODS	The changes in blood pressure and heart rate , visual analogue scale ( VAS ) score , lithotripsy frequency till calculi complete removal and the rate of calculi complete removal after the first lithotripsy were observed in the two groups .
RESULTS	In the control group , blood pressure and heart rate were higher during lithotripsy than those before lithotripsy ( both P < 0.05 ) .
RESULTS	In the observation group , the differences in blood pressure and heart rate were not significant statistically as compared with those before lithotripsy ( both P > 0.05 ) .
RESULTS	The blood pressure and heart rate during lithotripsy in the observation group were apparently lower than those in the control group ( both P < 0.05 ) .
RESULTS	VAS scores during lithotripsy in the observation group were lower apparently than those in the control group ( both P < 0.05 ) .
RESULTS	The lithotripsy frequency in the observation group was less than that in the control group .
RESULTS	The rate of calculi complete removal in 1 week after the first lithotripsy in the observation group was higher than that in the control group [ 75.0 % ( 24/32 ) vs 50.0 % ( 16/32 ) , P < 0.05 ] .
CONCLUSIONS	The flurphen mixture at Shenshu ( BL 23 ) significantly alleviates pain reaction in patients undergoing ESWL , avoids the fluctuation of hemodynamics and improves the clinical effect of lithotripsy .

###24903122
BACKGROUND	Despite progress , models that incorporate antecedent and mediating factors associated with shared decision making ( SDM ) - related outcomes remain limited .
BACKGROUND	An experimental study tests patient decision aid ( DA ) effects on a network of antecedents and mediators associated with patient empowerment prior to a medical decision-making consultation regarding cancer treatment .
METHODS	A pilot study initially evaluated measurement scales , model fit , and the overall effect of the DA experience .
METHODS	The pilot compared matched treatment and control group samples of US adult online panel members exposed to a vignette about meeting their dermatologist to decide on skin cancer treatment .
METHODS	The treatment group also experienced a skin cancer DA with treatment options and value clarification activity , while the control group did not .
METHODS	The main study employed a randomized experimental design to formally test hypothesized path coefficients across the groups .
RESULTS	The pilot study suggested an overall enhanced DA effect on self-empowerment .
RESULTS	In the experimental study , the DA experience strengthened the direct path from desire for medical information to self-empowerment and the indirect path from comprehension/participation confidence to self-empowerment through cancer attitude .
RESULTS	The DA had no strengthening effect on the direct path from life satisfaction to self-empowerment , but in the DA condition , the factor appeared to play a role by contributing to the enhanced association between confidence and cancer attitude .
CONCLUSIONS	Evidence from this research indicates that experiencing a DA prior to treatment decision making affects patient empowerment through a network that includes desire for information , life satisfaction , and multiple mediators .
CONCLUSIONS	The studies also demonstrate the role that theory-based , multigroup structural equation modeling ( SEM ) can play in increasing understanding of DA effects .
CONCLUSIONS	Such understanding is critical to improving SDM between patients and their physicians .

###24261926
METHODS	Randomized controlled trial .
OBJECTIVE	To determine the validity of a previously suggested clinical prediction rule ( CPR ) for identifying patients most likely to experience short-term success following lumbar stabilization exercise ( LSE ) .
OBJECTIVE	Background Although LSE is commonly used by physical therapists in the management of low back pain , it does not seem to be more effective than other interventions .
OBJECTIVE	A 4-item CPR for identifying patients most likely to benefit from LSE has been previously suggested but has yet to be validated .
METHODS	One hundred five patients with low back pain underwent a baseline examination to determine their status on the CPR ( positive or negative ) .
METHODS	Patients were stratified by CPR status and then randomized to receive an LSE program or an intervention consisting of manual therapy ( MT ) and range-of-motion/flexibility exercises .
METHODS	Both interventions included 11 treatment sessions delivered over 8 weeks .
METHODS	Low back pain-related disability was measured by the modified version of the Oswestry Disability Index at baseline and upon completion of treatment .
RESULTS	The statistical significance for the 2-way interaction between treatment group and CPR status for the level of disability at the end of the intervention was P = .17 .
RESULTS	However , among patients receiving LSE , those with a positive CPR status experienced less disability by the end of treatment compared with those with a negative CPR status ( P = .02 ) .
RESULTS	Also , among patients with a positive CPR status , those receiving LSE experienced less disability by the end of treatment compared with those receiving MT ( P = .03 ) .
RESULTS	In addition , there were main effects for treatment and CPR status .
RESULTS	Patients receiving LSE experienced less disability by the end of treatment compared to patients receiving MT ( P = .05 ) , and patients with a positive CPR status experienced less disability by the end of treatment compared to patients with a negative CPR status , regardless of the treatment received ( P = .04 ) .
RESULTS	When a modified version of the CPR ( mCPR ) containing only the presence of aberrant movement and a positive prone instability test was used , a significant interaction with treatment was found for final disability ( P = .02 ) .
RESULTS	Of the patients who received LSE , those with a positive mCPR status experienced less disability by the end of treatment compared to those with a negative mCPR status ( P = .02 ) , and among patients with a positive mCPR status , those who received LSE experienced less disability by the end of treatment compared to those who received MT ( P = .005 ) .
CONCLUSIONS	The previously suggested CPR for identifying patients likely to benefit from LSE could not be validated in this study .
CONCLUSIONS	However , due to its relatively low level of power , this study could not invalidate the CPR , either .
CONCLUSIONS	A modified version of the CPR that contains only 2 items may possess a better predictive validity to identify those most likely to succeed with an LSE program .
CONCLUSIONS	Because this modified version was established through post hoc testing , an additional study is recommended to prospectively test its predictive validity .
METHODS	Prognosis , level 1b - .

###24907435
OBJECTIVE	To evaluate the safety , tolerability and bioactivity of ascending doses of MP0112 , a designed ankyrin repeat protein ( DARPin ) that binds with high affinity to vascular endothelial growth factor-A ( VEGF-A ) , in treatment-naive patients with exudative age-related macular degeneration ( AMD ) .
METHODS	Phase I/II , open-label , multicenter , dose-escalation study .
METHODS	Patients were to receive a single intravitreal injection of MP0112 at doses ranging from 0.04 to 3.6 mg and be monitored for 16 weeks for safety , efficacy , pharmacokinetics , and dose response .
RESULTS	Altogether , 32 patients received a single injection of MP0112 .
RESULTS	The maximum tolerated dose was 1.0 mg because of a case of endophthalmitis in the 2.0 mg cohort .
RESULTS	Drug-related adverse events were reported by 13 ( 41 % ) of 32 patients ; they included ocular inflammation in 11 patients ( 7 mild , 4 moderate in severity ) .
RESULTS	Visual acuity scores were stable or improved compared with baseline for 4 weeks following injection ; both retinal thickness and fluorescein angiography leakage decreased in a dose-dependent manner .
RESULTS	Rescue therapy was administered to 20 ( 91 % ) of 22 patients who received 0.04-0 .4 mg MP0112 compared with 4 of 10 ( 40 % ) patients who received 1.0 or 2.0 mg .
RESULTS	Of patients in the higher-dose cohorts who did not require rescue treatment , 83 % ( 5/6 ) maintained reductions in central retinal thickness through week 16 .
CONCLUSIONS	A single injection of 1.0 or 2.0 mg MP0112 resulted in mean decreases in retinal thickness and leakage area despite ocular inflammation .
CONCLUSIONS	Larger-scale studies are warranted to confirm these observations .

###24485283
BACKGROUND	Major depressive disorder ( MDD ) imposes a considerable disease burden on individuals and societies .
BACKGROUND	Web-based interventions have shown to be effective in reducing depressive symptom severity .
BACKGROUND	However , it is not known whether web-based interventions may also be effective in preventing the onset of MDD .
BACKGROUND	The aim of this study is to evaluate the ( cost - ) effectiveness of an indicated web-based guided self-help intervention ( GET.ON Mood Enhancer Prevention ) on the onset of MDD .
METHODS	A randomised controlled trial ( RCT ) will be conducted to compare the ( cost - ) effectiveness of the GET.ON Mood Enhancer Prevention training with a control condition exclusively receiving online-based psychoeducation on depression .
METHODS	Adults with subthreshold depression ( N = 406 ) will be recruited from the general population and randomised to one of the two conditions .
METHODS	The primary outcome is time to onset of MDD within a 12-months follow-up period .
METHODS	MDD will be assessed according to DSM-IV criteria as assessed by the telephone-administered Structured Clinical Interview for DSM-IV ( SCID ) .
METHODS	Time to onset of MDD will be assessed using life charts .
METHODS	Secondary outcomes include changes on various indicators of depressive symptom severity , anxiety and quality of life from baseline to post-treatment , to a 6-month and a 12-month follow up .
METHODS	Additionally , an economic evaluation using a societal perspective will be conducted to examine the intervention 's cost-effectiveness .
CONCLUSIONS	This is one of the first randomised controlled trials that examines the effect of an indicated guided self-help web-based intervention on the incidence of major depression .
CONCLUSIONS	If shown to be effective , the intervention will contribute to reducing the disease burden due to MDD in the general population .
BACKGROUND	German Clinical Trial Registration DRKS00004709 .

###25495543
BACKGROUND	Due to improved treatments and ageing population , many countries now report increasing prevalence in rates of ischemic heart disease and heart failure .
BACKGROUND	Cardiac rehabilitation has potential to reduce morbidity and mortality , but not all patients complete .
BACKGROUND	In light of favourable effects of cardiac rehabilitation it is important to develop patient education methods which can enhance adherence to this effective program .
BACKGROUND	The LC-REHAB study aims to compare the effect of a new patient education strategy in cardiac rehabilitation called ` learning and coping ' to that of standard care .
BACKGROUND	Further , this paper aims to describe the theoretical basis and details of this intervention .
METHODS	Open parallel randomised controlled trial conducted in three hospital units in Denmark among patients recently discharged with ischemic heart disease or heart failure .
METHODS	Patients are allocated to either the intervention group with learning and coping strategies incorporated into standard care in cardiac rehabilitation or the control group who receive the usual cardiac rehabilitation program .
METHODS	Learning and coping consists of two individual clarifying interviews , participation of experienced patients as educators together with health professionals and theory based , situated and inductive teaching .
METHODS	Usual care in cardiac rehabilitation is characterised by a structured deductive teaching style with use of identical pre-written slides in all hospital units .
METHODS	In both groups , cardiac rehabilitation consists of training three times a week and education once a week over eight weeks .
METHODS	The primary outcomes are adherence to cardiac rehabilitation , morbidity and mortality , while secondary outcomes are quality of life ( SF-12 , Health education impact questionnaire and Major Depression Inventory ) and lifestyle and risk factors ( Body Mass Index , waist circumference , blood pressure , exercise work capacity , lipid profile and DXA-scan ) .
METHODS	Data collection occurs four times ; at baseline , at immediate completion of cardiac rehabilitation , and at three months and three years after the finished program .
CONCLUSIONS	It is expected that learning and coping incorporated in cardiac rehabilitation will improve adherence in cardiac rehabilitation and may decrease morbidity and mortality .
CONCLUSIONS	By describing learning and coping strategies the study aims to provide knowledge that can contribute to an increased transparency in patient education in cardiac rehabilitation .
BACKGROUND	Identifier NCT01668394 .

###25266967
BACKGROUND	Health Economists in Denmark have reported poor outcomes and low and delayed return to work for patients treated for Sub-Acromial Impingement syndrome ( SAIS ) by Arthroscopic Sub-Acromial Decompression ( ASAD ) .
BACKGROUND	In this setting it is important to evaluate outcomes following this commonly performed operation to justify undertaking it on our patients .
BACKGROUND	The purpose of the study was to evaluate the effectiveness of ASAD for patients with SAIS and correlate clinical outcome with rate of return to work .
METHODS	Prospective cohort study and retrospective review of data from the Nottingham Shoulder database .
METHODS	Inclusion criteria : Patients diagnosed clinically with SAIS by an experienced shoulder surgeon , who have failed conservative treatment ( physiotherapy and sub-acromial injection ) , undergoing ASAD .
METHODS	Pre-operative and 6-month post-operative Oxford Shoulder Score ( OSS ) and Constant Score ( CS ) were compared .
METHODS	The rates of return to pre-operative work and hobbies were also analysed .
METHODS	Statistical analysis was carried out using the Wilcoxon signed rank test .
RESULTS	73 patients with OSS ( 51 also with CS documentation ) were included .
RESULTS	The improvement in median OSS between pre-operative ( 24 ) and 6-month follow-up ( 39 ) was +15 ( Z = -6.726 , p < 0.0001 , T = 6 , r = 0.55 ) .
RESULTS	The difference in median CS between pre-operative ( 39 ) and 6-month follow-up ( 67 ) was +28 ( Z = -5.435 , p < 0.0001 , T = 6 , r = 0.59 ) .
RESULTS	Improvement in median pain score was +5 ( 7,12 , p < 0.0001 ) median ADL was +5.5 ( 10.5,16 , p < 0.0001 ) median ROM was +13 ( 18,31 , p < 0.0001 ) and median strength was +4 ( 3,7 , p < 0.0001 ) .
RESULTS	76 % returned to their pre-operative level of work ( mean time = 11.5 weeks post surgery ) .
RESULTS	79 % returned to pre-operative hobbies at a mean of 11.8 weeks after surgery .
CONCLUSIONS	There is a significant improvement in both subjective and objective outcome 6 months after ASAD in patients with SAIS who have had previous failed conservative treatment .
CONCLUSIONS	The rate of return to work was good for these patients in contrast to that reported for Danish patients .
CONCLUSIONS	ASAD is a successful method of treatment for patients with SAIS who have had an initial trial of failed conservative treatment .

###24862085
OBJECTIVE	Up to 18.1 % of Dutch children aged 3-5 are overweight and up to 3.3 % are obese , with higher levels in girls .
OBJECTIVE	This study assessed the effect of a multidisciplinary intervention programme on health-related quality of life ( HRQoL ) in this patient group .
METHODS	We randomised 75 children to a multidisciplinary intervention , comprising dietary advice , exercise sessions and psychological counselling for parents or the standard care programme , providing healthy lifestyle advice .
METHODS	The parents completed quality of life and child health questionnaires at baseline and after 16weeks and 12months .
RESULTS	At 16weeks , children in the intervention group experienced more bodily pain and less mental health than the standard care group , but at 12months , this difference disappeared and they showed a more positive change in HRQoL than the standard care group , especially for the physical domain .
RESULTS	When we combined both groups , a decreased BMIz-score over 12months was associated with increased global health and reduced visceral fat correlated with increased general health .
CONCLUSIONS	At 12months , a multidisciplinary intervention programme for overweight and obese children aged 3-5years had beneficial effects on HRQoL , especially for the physical domain .
CONCLUSIONS	Reduced obesity parameters correlated with several increased HRQoL parameters .

###24329929
OBJECTIVE	The study aimed to evaluate the effect of 0.25 % sodium hypochlorite twice-weekly oral rinse on plaque and gingivitis in patients with minimally treated periodontitis .
METHODS	The study included 30 patients with periodontitis , it lasted 3mo , and it was performed as a randomized , controlled , single-blinded , clinical trial in parallel groups .
METHODS	Fifteen patients rinsed for 30s with 15mL of a fresh solution of 0.25 % sodium hypochlorite ( test ) and 15 patients rinsed with 15mL of water ( control ) .
METHODS	Clorox ( ) regular bleach was the source of the sodium hypochlorite .
METHODS	At baseline and at 2wk , the study patients received professional subgingival irrigation for 5min with either 0.25 % sodium hypochlorite or water , but no subgingival or supragingival scaling .
METHODS	The presence or absence of supragingival plaque on facial and lingual surfaces was determined by visual inspection ; each tooth was dried with air and mouth mirror rotation was used to provide light reflection to identify plaque on smooth surfaces and at the tooth line angles .
METHODS	Gingival bleeding within 30s after probing to full pocket depth was assessed in six sites of each tooth .
METHODS	Adverse events were evaluated by questionnaire and visual examination .
RESULTS	All 30 patients in the study completed the baseline and the 2wk parts of the study and a subset of 12 participants completed the 3mo part of the study .
RESULTS	The sodium hypochlorite rinse group and the water rinse group , respectively , showed increases from baseline to 3mo of 94 % and 29 % ( 3.2-fold difference ) in plaque-free facial surfaces , of 195 % and 30 % ( 6.5-fold difference ) in plaque-free lingual surfaces , and of 421 % and 29 % ( 14.5-fold difference ) in number of teeth with no bleeding on probing .
RESULTS	The differences in clinical improvement between the sodium hypochlorite rinse group and the water rinse group were statistically significant .
RESULTS	No adverse events were identified in any of the study patients , except for minor complaints about the taste of bleach .
CONCLUSIONS	A twice-weekly oral rinse with 0.25 % sodium hypochlorite produced marked decreases in dental plaque level and bleeding on probing and may constitute a promising new approach to the management of periodontal disease .
CONCLUSIONS	Long-term controlled studies on the effectiveness of sodium hypochlorite oral rinse are needed and encouraged .

###25039544
BACKGROUND	There is no evidence regarding the several short-term prophylaxis protocols for contrast-induced nephropathy ( CIN ) that may be most feasibly convenient in emergency settings .
OBJECTIVE	The purpose of this study was to compare the efficacies of short-term CIN prophylaxis protocols of normal saline , N-acetylcysteine ( NAC ) plus saline , and sodium bicarbonate plus saline in emergency department ( ED ) patients at moderate or high risk of CIN after receiving intravenous ( IV ) contrast agent .
METHODS	This single-center , randomized , nonblinded clinical trial was conducted in the ED with adult patients requiring contrast-enhanced computed tomography ( CT ) .
METHODS	Patients with moderate to high risk of CIN according to the Mehran risk score , who consented to participate , were eligible .
METHODS	Patients with continuous renal replacement therapy or who reported contrast allergy were excluded .
METHODS	Enrolled patients were randomly assigned to receive 150 mg/kg NAC in 1000 mL of 0.9 % sodium chloride ( NaCl ) , 150 mEq of sodium bicarbonate in 1000 mL of 0.9 % NaCl , or 1000 mL of IV saline infusion , all given at 350 mL/hr for 3 hours .
METHODS	All of the patients were administered less than 100 mL of nonionic , low-osmolality contrast agent .
METHODS	The primary outcome of CIN was defined as a 25 % increase or a greater than 0.5 mg/dL increase in the serum creatinine level 48 to 72 hours later compared with the baseline measurement .
RESULTS	A total of 107 patients were randomized to NAC ( n = 36 ) , sodium bicarbonate ( n = 36 ) , and saline prophylaxis ( n = 35 ) .
RESULTS	The mean age of the patients was 71 years ( 95 % confidence interval [ CI ] = 65 to 77 years ) , and 58 ( 54.2 % ) were male .
RESULTS	The groups were similar regarding baseline characteristics and nephropathy risks .
RESULTS	Of the 16 ( 14.9 % ) patients who eventually developed CIN , seven ( 19.4 % ) were in the NAC plus saline group , four ( 11.1 % ) were in the sodium bicarbonate plus saline group , and five ( 14.2 % ) were in the saline group .
RESULTS	There were no significant differences between the groups in terms of the prevention of CIN ( p = 0.60 ) .
CONCLUSIONS	None of the short-term protocols with normal saline , NAC , or sodium bicarbonate was superior in ED patients requiring contrast-enhanced CT who had a moderate or high risk of CIN .

###25604019
OBJECTIVE	To evaluate the erectile function of male patients treated by neoadjuvant radiochemotherapy and neoadjuvant chemotherapy alone for mid-low rectal cancer .
METHODS	The clinical data of 66 patients with rectal cancer from March 2011 to March 2013 were prospectively analyzed .
METHODS	Of all the patients , 56 cases were finally included in the study and were randomly allocated to two groups .
METHODS	Thirty patients were treated by neoadjuvant radiochemotherapy followed by surgery ( RCS group ) , and 26 were treated by neoadjuvant chemotherapy followed by surgery ( NCS group ) .
METHODS	The five-item version of the international index of erectile function ( IIEF-5 ) questionnaire were used to determine erectile function before therapy and at least 12 months after surgery .
METHODS	The impacts of age , location , size of tumor , and body mass index on erectile function were analyzed .
RESULTS	Total score was decreased significantly at follow-up compared to initial assessment in both RCS and NCS groups ( 23.4 1.30 vs. 11.7 5.8 , t = 10.748 , P < 0.01 ; 23.1 1.3 vs. 15.2 6.7 , t = 5.910 , P < 0.01 , respectively ) .
RESULTS	Score difference was statistically higher in RCS group compared with NCS group ( 11.7 5.6 vs. 8.0 6.0 , t = 2.394 , P = 0.020 ) .
RESULTS	In terms of tumor location for RCS group , difference was statistically higher in the patients with low rectal cancer compared with those with middle rectal cancer ( 14.5 3.5 vs. 9.5 6.0 , t = 2.894 , P = 0.008 ) .
CONCLUSIONS	The erectile functions of patients treated by neoadjuvant radiochemotherapy followed by surgery are more affected than that of patients treated by neoadjuvant chemotherapy followed by surgery in mid-low rectal cancer .
CONCLUSIONS	Also low rectal cancer are significantly associated with erectile dysfunction in the patients treated by neoadjuvant radiochemotherapy followed by surgery .

###24285938
OBJECTIVE	We planned to compare the impact of two beta blockers , metoprolol and nebivolol , on arterial blood pressure during exercise in patients with mild hypertension .
METHODS	A total of 60 patients ( 13 males , 47 females ; mean age : 54.3 10.7 years ) were enrolled in the present study .
METHODS	The patients were randomly selected to receive either nebivolol 5mg/day ( n = 30 ) or metoprolol 50mg/day ( n = 30 ) for 8 weeks .
METHODS	At the end of the 8th week , each of the patients received exercise stress test according to Bruce protocol and their blood pressures were remeasured after rest , exercise , and recovery .
RESULTS	Blood pressures were determined to be similar between metoprolol and nebivolol groups during rest , exercise , and recovery periods .
RESULTS	Metoprolol and nebivolol achieved similar reductions in blood pressures during rest and exercise .
RESULTS	However , five patients in nebivolol group and four patients in metoprolol group developed exaggerated BP response to exercise but the difference between metoprolol and nebivolol was not meaningful ( P = 0.37 ) .
CONCLUSIONS	The results of the present study showed that metoprolol and nebivolol established comparable effects on the control of blood pressures during exercise in the patients with mild hypertensions .

###25055491
OBJECTIVE	To compare the efficacy of Dexmedetomidine and Propofol for short-term controlled sedation and analgesia in the early postoperative period after cardiac surgery .
METHODS	We performed open randomized prospective comparative study in 55 cardiovascular surgery patients .
METHODS	In the early postoperative period 28 patients received infusion of Dexmedetomidine ( 0.2-0 .7 microg/kg per hour ) while 27 patients -- Propofol ( 0.3-2 ( system text of symbol ) ) .
METHODS	Analgesia was carried out with Ketoprofen 100 mg/12h and additional 20 mg of Trimeperidine in case of pain intensity > or = 3 points ( 5-level verbal pain score ) .
METHODS	Sedation and agitation level ( RASS scale ) , speed of awakening ( Aldrete score ) , duration of mechanical ventilation and stay in the ICU , need for additional opioid injections , type and frequency of side effects were evaluated .
RESULTS	We did n't find any significant differences in the duration of mechanical ventilation or rate of awakening after the end of infusion between the groups .
RESULTS	Dexmedetomidine in the majority of cases resulted in mild or moderate sedation , Propofol -- in deeper level of sedation .
RESULTS	Retrograde amnesia was reached significantly more often ( p < 0.05 ) in Dexmetomedine group .
RESULTS	The daily dose of Trimeperidine in Propofol group was significantly higher ( 8 mg and 18 mg on average , p = 0.02 ) .
RESULTS	Differences in side effects between the groups were noted -- bradycardia ( Dexmetomedine -- 10 ( 39 % ) , Propofol -- 3 ( 11 % ) , p = 0.004 ) arterial hypotension ( Dexmetomedine -- 9 ( 32 % ) , Propofol -- 15 ( 59 % ) , p = 0.002 ) and general malaise ( Dexmetomedine -- 2 ( 7 % ) , Propofol -- 6 ( 24 % ) , p = 0.001 ) .
RESULTS	The length of stay in the ICU in Dexmetomedine group was significantly lower ( 1,1 days vs 2,6 days respectively , p = 0.006 ) .
CONCLUSIONS	To compare with Propofol Dexmetomedine induces less sedation level and more often provides retrograde amnesia with the same duration of mechanical ventilation and awakening rate .
CONCLUSIONS	Dexmetomedine provides its own analgesic effect and shortens the length of patient 's stay in ICU .
CONCLUSIONS	Bradycardia was noted more frequently in Dexmedetomidine while arterial hypotension , general malaise and delirium -- in Propofol group .

###24517339
OBJECTIVE	To characterize genital mycotic infections with canagliflozin , a sodium glucose co-transporter 2 inhibitor , in patients with type 2 diabetes mellitus ( T2DM ) using pooled data from Phase 3 studies .
METHODS	Genital mycotic infections with canagliflozin 100 and 300mg were evaluated in Population 1 ( N = 2313 ; mean exposure [ weeks ] : canagliflozin , 24.3 ; placebo , 23.8 ) , including patients from four placebo-controlled studies , and Population 2 ( N = 9439 ; mean exposure [ weeks ] : canagliflozin , 68.1 ; control , 64.4 ) , including patients from eight placebo/active-controlled studies ( including older patients and those with renal impairment or high cardiovascular disease risk ) .
BACKGROUND	ClinicalTrials.gov , NCT01081834 ; NCT01106625 ; NCT01106677 ; NCT01106690 ; NCT01032629 ; NCT01064414 ; NCT01106651 ; NCT00968812 .
METHODS	Adverse events suggestive of genital mycotic infections were recorded , with additional information collected using supplemental electronic case report forms .
RESULTS	In Population 1 , genital mycotic infection incidence was higher with canagliflozin 100 and 300mg than placebo ( 95 % confidence intervals excluded zero ) in females ( 10.4 % , 11.4 % , 3.2 % ) and males ( 4.2 % , 3.7 % , 0.6 % ) .
RESULTS	These were generally mild to moderate in intensity , none were serious , and few led to discontinuation .
RESULTS	Most events with canagliflozin were treated with antifungal therapies , and median symptom duration following treatment initiation was similar across groups ; few patients had > 1 event ( females , 2.3 % ; males , 0.9 % ) .
RESULTS	Findings with canagliflozin 100 and 300mg versus control were similar in Population 2 ( females : 14.7 % , 13.9 % , 3.1 % ; males : 7.3 % , 9.3 % , 1.6 % ) ; a low proportion of males underwent circumcision across groups .
RESULTS	Most events with canagliflozin occurred within the first 4 months in females and first year in males ; no consistent evidence of dose dependence was observed .
RESULTS	Key limitations included lack of laboratory confirmation for most events and variable treatment methods .
CONCLUSIONS	Genital mycotic infection incidences were higher with canagliflozin than control in patients with T2DM ; events were generally mild to moderate in intensity and responded to standard treatments .

###24337339
OBJECTIVE	Psychiatric stigma is a major barrier to the recovery of persons with serious mental illnesses .
OBJECTIVE	This study tested the efficacy of an innovative peer-run photography-based intervention , called antistigma photovoice , which targets self-stigma and promotes proactive coping with public stigma .
METHODS	A total of 82 individuals with serious mental illnesses enrolled at a university-based recovery center were randomly assigned to the antistigma photovoice program or to a wait-list control group .
METHODS	Mixed-effects regression models were used to examine the impact of photovoice on self-stigma , coping with stigma , empowerment , perceived recovery , self-efficacy , and depression .
RESULTS	Participation in the photovoice intervention was associated with significantly reduced self-stigma , greater use of proactive coping with societal stigma , greater increase in a sense of community activism , and perceived recovery and growth .
CONCLUSIONS	The photovoice intervention demonstrated promise for reducing self-stigma and enhancing proactive coping with prejudice and discrimination .

###24608864
BACKGROUND	Accurate immunosuppression is of critical importance in preventing rejection , while avoiding toxicity following lung transplantation .
BACKGROUND	The mainstay immunosuppressants are calcineurin inhibitors , which require regular monitoring due to interactions with other medications and diet .
BACKGROUND	Adherence to immunosuppression and patient knowledge is vital and can be improved through patient education .
BACKGROUND	Education using tablet-computers was investigated .
OBJECTIVE	To compare tablet-PC education and conventional education in improving immunosuppression trough levels in target range 6 months after a single education .
OBJECTIVE	Secondary parameters were ratio of immunosuppression level measurements divided by per protocol recommended measurements , time and patient satisfaction regarding education .
METHODS	Single-centre , open labelled randomised controlled trial .
METHODS	Patients > 6 months after lung-transplantation with < 50 % of calcineurin inhibitor trough levels in target range .
METHODS	Tablet-pc education versus personal , nurse-led education .
METHODS	Calcineurin inhibitor levels in target range 6 months after education , level variability , interval adherence , knowledge and adherence was studied .
METHODS	As outcome parameter , renal function was measured and adverse events registered .
RESULTS	Sixty-four patients were 1:1 randomised for either intervention .
RESULTS	Levels of immunosuppression 6 months after education were equal ( tablet-PC 58 % vs. conventional 48 % , p = 0.27 ) , both groups improved in achieving a CNI trough level within target range by either education method ( delta tablet-PC 29 % vs. conventional 20 % ) .
RESULTS	In all patients , level variability decreased ( -20.4 % ) , whereas interval adherence remained unchanged .
RESULTS	Knowledge about immunosuppression improved by 7 % and compliance tests demonstrated universal improvements with no significant difference between groups .
CONCLUSIONS	Education is a simple , effective tool in improving adherence to immunosuppression .
CONCLUSIONS	Tablet-PC education was non-inferior to conventional education .
BACKGROUND	ClinicalTrials.gov NCT01398488 http://clinicaltrials.gov/ct2/show/NCT01398488 ?
BACKGROUND	term = gottlieb + tablet + pc + education & rank = 1 .

###24717919
BACKGROUND	Surgery for colorectal liver metastases results in an overall survival of about 40 % at 5 years .
BACKGROUND	Progression-free survival is increased with the addition of oxaliplatin and fluorouracil chemotherapy .
BACKGROUND	The addition of cetuximab to these chemotherapy regimens results in an overall survival advantage in patients with advanced disease who have the KRAS exon 2 wild-type tumour genotype .
BACKGROUND	We aimed to assess the benefit of addition of cetuximab to standard chemotherapy in patients with resectable colorectal liver metastasis .
METHODS	Patients with KRAS exon 2 wild-type resectable or suboptimally resectable colorectal liver metastases were randomised in a 1:1 ratio to receive chemotherapy with or without cetuximab before and after liver resection .
METHODS	Randomisation was done using minimisation with factors of surgical centre , poor prognostic tumour ( one or more of : 4 metastases , N2 disease , or poor differentiation of primary tumour ) , and previous adjuvant treatment with oxaliplatin .
METHODS	Chemotherapy consisted of oxaliplatin 85 mg/m ( 2 ) intravenously over 2 h and fluorouracil bolus 400 mg/m ( 2 ) intravenously over 5 min , followed by a 46 h infusion of fluorouracil 2400 mg/m ( 2 ) repeated every 2 weeks ( regimen one ) or oxaliplatin 130 mg/m ( 2 ) intravenously over 2 h and oral capecitabine 1000 mg/m ( 2 ) twice daily on days 1-14 repeated every 3 weeks ( regimen two ) .
METHODS	Patients who had received adjuvant oxaliplatin could receive irinotecan 180 mg/m ( 2 ) intravenously over 30 min with fluorouracil instead of oxaliplatin ( regimen three ) .
METHODS	Cetuximab was given as an intravenous dose of 500 mg/m ( 2 ) every 2 weeks with regimen one and three or a loading dose of 400 mg/m ( 2 ) followed by a weekly infusion of 250 mg/m ( 2 ) with regimen two .
METHODS	The primary endpoint was progression-free survival .
METHODS	This is an interim analysis , up to Nov 1 , 2012 , when the trial was closed , having met protocol-defined futility criteria .
METHODS	This trial is registered , ISRCTN22944367 .
RESULTS	128 KRAS exon 2 wild-type patients were randomised to chemotherapy alone and 129 to chemotherapy with cetuximab between Feb 26 , 2007 , and Nov 1 , 2012.117 patients in the chemotherapy alone group and 119 in the chemotherapy plus cetuximab group were included in the primary analysis .
RESULTS	The median follow-up was 21.1 months ( 95 % CI 12.6-33 .8 ) in the chemotherapy alone group and 19.8 months ( 12.2-28 .7 ) in the chemotherapy plus cetuximab group .
RESULTS	With an overall median follow-up of 20.7 months ( 95 % CI 17.9-25 .6 ) and 123 ( 58 % ) of 212 required events observed , progression-free survival was significantly shorter in the chemotherapy plus cetuximab group than in the chemotherapy alone group ( 14.1 months [ 95 % CI 11.8-15 .9 ] vs 20.5 months [ 95 % CI 16.8-26 .7 ] , hazard ratio 1.48 , 95 % CI 1.04-2 .12 , p = 0.030 ) .
RESULTS	The most common grade 3 or 4 adverse events were low neutrophil count ( 15 [ 11 % ] preoperatively in the chemotherapy alone group vs six [ 4 % ] in the chemotherapy plus cetuximab group ; four [ 4 % ] vs eight [ 8 % ] postoperatively ) , embolic events ( six [ 4 % ] vs eight [ 6 % ] preoperatively ; two [ 2 % ] vs three [ 3 % ] postoperatively ) , peripheral neuropathy ( six [ 4 % ] vs one [ 1 % ] preoperatively ; two [ 2 % ] vs four [ 4 % ] postoperatively ) , nausea or vomiting ( four [ 3 % ] vs six [ 4 % ] preoperatively ; four [ 4 % ] vs two [ 2 % ] postoperatively ) , and skin rash ( two [ 1 % ] vs 21 [ 15 % ] preoperatively ; 0 vs eight [ 8 % ] postoperatively ) .
RESULTS	There were three deaths in the chemotherapy plus cetuximab group ( one interstitial lung disease and pulmonary embolism , one bronchopneumonia , and one pulmonary embolism ) and one in the chemotherapy alone group ( heart failure ) that might have been treatment related .
CONCLUSIONS	Addition of cetuximab to chemotherapy and surgery for operable colorectal liver metastases in KRAS exon 2 wild-type patients results in shorter progression-free survival .
CONCLUSIONS	Translational investigations to explore the molecular basis for this unexpected interaction are needed but at present the use of cetuximab in this setting can not be recommended .

###24519331
OBJECTIVE	To determine whether mental practice of wrist movements during forearm immobilization maintains range of motion .
METHODS	Randomized controlled trial .
METHODS	Eighteen healthy young men aged between 20 and 30 years were assigned to either a control or a mental practice group .
METHODS	Both groups were immobilized with a circular forearm cast for 3 weeks to simulate a distal radial fracture .
METHODS	The mental practice group received 1 60-min , followed by 3 30-min , sessions of supervised mental practice .
METHODS	Consecutively , they were asked to perform 15 min/day of self-guided imagery sessions , during which they mentally exercised motion sequences of the immobilized joint .
METHODS	The training program followed the Mental Gait Training procedure .
METHODS	The control group did no training .
METHODS	Wrist movement was measured with a goniometer before and after immobilization .
RESULTS	Mental practice preserved dorsal extension and ulnar abduction .
RESULTS	The sedentary control group showed due to this variables a significant decrease after cast removal .
RESULTS	There was no significant change in palmar flexion and radial abduction in either group .
CONCLUSIONS	Despite the study limitations , these results suggest that mental practice may be useful in preventing loss of hand function associated with mid-term immobilization .
CONCLUSIONS	Because of the expected clinical benefits , the low cost and simple application of the intervention , the effects of mental practice in orthopedic rehabilitation of the upper extremity warrant further study .

###24460303
OBJECTIVE	To assess the effects of perioperative comprehensive supportive care interventions on outcome of Chinese esophageal cancer patients in a prospective study .
METHODS	60 patients with primary esophageal carcinoma were randomized into an intervention group ( IG , n = 31 ) and a control group ( CG , n = 29 ) .
METHODS	The Chinese version of symptom checklist-90 ( SCL-90 ) was adopted to assess their psychological status .
METHODS	The interventions , including health education , psychological support , stress management , coping strategies and behavior training , were carried out in 3 phases ( preoperative , postoperative I and postoperative II ) , and psychological effects were thereafter evaluated accordingly before surgery , and 1 week , 4 weeks and 24 weeks post-surgery .
METHODS	Medical costs were estimated at discharge .
METHODS	Survival of patients was estimated each year post-surgery .
METHODS	General health status and satisfaction-with-hospital were surveyed by a follow-up questionnaire 4 years post-surgery .
RESULTS	All the subjects demonstrated higher scores in the preoperative phase than the normal range of Chinese population concerning 7 psychological domains including somatization , obsessive-compulsive , depression , anxiety , hostility , phobic anxiety and paranoid ideation .
RESULTS	Although no significant difference was observed between the two groups at admission , the scores of IG , which tended to decrease at a faster rate , were generally lower than those of CG at weeks 1 , 4 and 24 post-surgery .
RESULTS	The length of hospital stay and medical costs of IG were significantly less than those of CG and satisfaction-with-hospital was better .
RESULTS	However , there was no significant difference in 4-year survival or health status between two groups .
CONCLUSIONS	Appropriate perioperative comprehensive supportive care interventions help to improve the psychological state of Chinese patients with esophageal carcinoma , to reduce health care costs and to promote satisfaction of patients and their families with hospital .

###24666210
BACKGROUND	The assurance of high-quality spirometry testing remains a challenge .
METHODS	Spirometry training consisted of standardized coaching followed by certification for 35 spirometry-nave and 9 spirometry-experienced research assistants .
METHODS	Spirometry was performed before and after bronchodilator ( BD ) in random population samples of 5176 people aged 40 years and older from 9 sites in Canada .
METHODS	using the hand-held EasyOne spirometer ( ndd Medical Technologies Inc. , Andover , MA , USA ) .
METHODS	Pulmonary function quality assurance with over reading was conducted centrally in Vancouver : spirograms were reviewed and graded according to ATS/ERS standards with prompt feedback to the technician at each site .
METHODS	Descriptive statistics were calculated for manoeuvre acceptability and repeatability variables .
METHODS	A logistic regression model was constructed for the predictors of spirometry quality success .
RESULTS	95 % of test sessions achieved pre-determined quality standards for back extrapolated volume ( BEV ) , time to peak flow ( PEFT ) and end of test volume ( EOTV ) .
RESULTS	The mean forced expiratory time ( FET ) was 11.2 seconds .
RESULTS	Then , 90 % and 95 % of all manoeuvres had FEV1 and FVC that were repeatable within 150 ml and 200 ml respectively .
RESULTS	Test quality was slightly better for post-BD test sessions compared with pre-BD for both groups of research assistants .
RESULTS	Independent predictors of acceptable test quality included participant characteristics : female sex , younger age , greater BD responsiveness ; but not study site or prior experience in completing spirometry by the technologist .
CONCLUSIONS	Good quality spirometry tests are attainable in large multicenter epidemiological studies by trained research assistants , irrespective of their prior experience in spirometry .

###24457253
BACKGROUND	RECOVER ( NCT00474058 ) , a double-blind , placebo-controlled trial in patients with Parkinson 's disease ( PD ) and unsatisfactory early-morning motor symptom control , demonstrated significant improvements with rotigotine in early-morning motor function ( Unified Parkinson 's Disease Rating Scale [ UPDRS ] III ) , and nocturnal sleep disturbances ( modified Parkinson 's Disease Sleep Scale [ PDSS-2 ] ) , and improvements in nonmotor symptoms ( NMS ; Non-Motor Symptom Scale [ NMSS ] ) .
METHODS	Post hoc analyses investigated the correlation between motor symptom and NMS severity in PD by evaluating associations between UPDRS III and both NMSS and PDSS-2 scores .
METHODS	Categories were defined for UPDRS III , NMSS , and PDSS-2 total scores ; analyses were conducted for the full analysis set ( n = 267 ) .
RESULTS	There was a trend toward increasing PDSS-2 and NMSS total and domain scores with increasing UPDRS III category at baseline and end of maintenance ( EoM ) .
RESULTS	Pearson correlation coefficients between UPDRS III and both NMSS and PDSS-2 total and domain scores were r = 0.12-0 .44 ( r ( 2 ) = 0.01-0 .19 ) at baseline , r = 0.05-0 .38 ( r ( 2 ) = 0.00-0 .14 ) at EoM , and r = -0.02 -0.36 ( r ( 2 ) = 0.00-0 .13 ) for change from baseline to EoM .
CONCLUSIONS	There was only a small correlation between severity of early-morning motor symptoms and overall burden of NMS and nocturnal sleep disturbances in RECOVER , suggesting that motor symptoms and NMS originate , at least partly , from distinct pathophysiological pathways .

###24947281
OBJECTIVE	To evaluate a multistrain , high-dose probiotic in the prevention of eczema .
METHODS	A randomised , double-blind , placebo-controlled , parallel group trial .
METHODS	Antenatal clinics , research clinic , children at home .
METHODS	Pregnant women and their infants .
METHODS	Women from 36weeks gestation and their infants to age 6months received daily either the probiotic ( Lactobacillus salivarius CUL61 , Lactobacillus paracasei CUL08 , Bifidobacterium animalis subspecies lactis CUL34 and Bifidobacterium bifidum CUL20 ; total of 10 ( 10 ) organisms/day ) or matching placebo .
METHODS	Diagnosed eczema at age 2years .
METHODS	Infants were followed up by questionnaire .
METHODS	Clinical examination and skin prick tests to common allergens were done at 6months and 2years .
RESULTS	The cumulative frequency of diagnosed eczema at 2years was similar in the probiotic ( 73/214 , 34.1 % ) and placebo arms ( 72/222 , 32.4 % ; OR 1.07 , 95 % CI 0.72 to 1.6 ) .
RESULTS	Among the secondary outcomes , the cumulative frequency of skin prick sensitivity at 2years was reduced in the probiotic ( 18/171 ; 10.5 % ) compared with the placebo arm ( 32/173 ; 18.5 % ; OR 0.52 , 95 % CI 0.28 to 0.98 ) .
RESULTS	The statistically significant differences between the arms were mainly in sensitisation to cow 's milk and hen 's egg proteins at 6months .
RESULTS	Atopic eczema occurred in 9/171 ( 5.3 % ) children in the probiotic arm and 21/173 ( 12.1 % ) in the placebo arm ( OR 0.40 , 95 % CI 0.18 to 0.91 ) .
CONCLUSIONS	The study did not provide evidence that the probiotic either prevented eczema during the study or reduced its severity .
CONCLUSIONS	However , the probiotic seemed to prevent atopic sensitisation to common food allergens and so reduce the incidence of atopic eczema in early childhood .
BACKGROUND	ISRCTN26287422 .

###24617160
OBJECTIVE	To estimate the prevalence of primary dysmenorrhoea among school girls and to compare the impact of exercise and hot water bottle on the occurrence and severity of primary dysmenorrhoea among the study population .
METHODS	A cross sectional study was done to estimate the prevalence of dysmenorrhoea in two schools of Chandigarh , India .
METHODS	For the Randomised Controlled Trial , group randomisation of the two schools was done into 2 intervention groups ( exercise & hot water bottle groups ) .
METHODS	53 girls in school 1 and 75 girls in school 2 participated in the intervention .
METHODS	Comparison of baseline Menstrual Distress Questionnaire ( MDQ ) scores & Visual Analogue Scale for Pain ( VASP ) scores were done with 1st , 2nd & 3rd month post intervention scores using mean , standard deviation , t-test .
RESULTS	Prevalence of dysmenorrhoea was 60.7 % .
RESULTS	Median age of the school girls was 14 years .
RESULTS	The mean VASP score decreased from 5.75 to 2.96 ( P < 0.0001 ) and from 5.16 to 2.06 ( P < 0.0001 ) at 3 months , in the exercise and hot water bottle group respectively .
RESULTS	The mean MDQ score decreased from 14.53 to 7.85 ( P < 0.0001 ) and from 14.92 to 8.16 ( P < 0.0001 ) at 3 months , in the exercise and hot water bottle group respectively .
CONCLUSIONS	Both exercise & hot water bottle can be used in dysmenorrhoeic girls in home setting to provide relief from pain and menstrual distress .

###25445103
OBJECTIVE	The efficacy of lidocaine-prilocaine cream ( EMLA ( ) ) analgesia in the practice of hysterosalpingography is controversial .
OBJECTIVE	This study provides new drill results and a new method of application in terms of mode , time and place .
OBJECTIVE	The aim of the paper is to investigate the efficacy of 5 % lidocaine 25 mg-prilocaine 25 mg/g cream applied to the uterine cervix for reducing pain during hysterosalpingography .
METHODS	A randomized , double blinded , controlled study set in the general gynaecology clinic of a university teaching hospital between September 2012 and June 2013 .
METHODS	One hundred successive patients programmed to undergo hysterosalpingography were randomized to either 3 ml of EMLA ( 50 ) cream or 3 ml of placebo ( 50 ) , placed endocervically and exocervically , 10 min before hysterosalpingography .
METHODS	Patients ' intensity of pain was assessed in four steps : at baseline ( speculum application ) , after application of Pozzi tenaculum and cannula on the uterine cervix , during cervical traction and after contrast medium injection , using a 10-cm Visual Analogue Scale ( VAS ) immediately after the procedure .
METHODS	The most painful step was also identified .
METHODS	VAS was administered again at one-month follow-up visit .
BACKGROUND	NCT01303614 .
RESULTS	The contrast medium injection was the most painful step of hysterosalpingography in both groups ( EMLA 3.96 , placebo 4.54 , 95 % CI : -0.481 to 1.641 ) .
RESULTS	No differences were found between the two groups ( P = 0.281 ) during this step .
RESULTS	When comparing the VAS scale after the application of Pozzi tenaculum and cannula ( EMLA 1.06 , placebo 3.34 , 95 % CI : 1.495-3 .065 ) and after cervical traction ( EMLA 2.54 , placebo 3.46 , 95 % CI : 0.034-1 .806 ) , significantly less pain was experienced by the EMLA group than the placebo group : P = 0.000 and P = 0.042 , respectively .
CONCLUSIONS	Endocervical and exocervical topical application of EMLA 10 min before performing hysterosalpingography significantly reduced pain during cervical manipulation with tenaculum and cannula and during cervical traction , but did not reduce pain during injection of contrast that was the most painful step .

###24595228
BACKGROUND	Inflammation is considered a key mediator of complications after cardiac surgery .
BACKGROUND	Sevoflurane has been shown to quench inflammation and to provide cardioprotection in preclinical studies .
BACKGROUND	Clinical studies using sevoflurane confirm this effect on inflammation but do not consistently show clinical benefits .
BACKGROUND	This paradox may indicate that the contribution of inflammation to postoperative sequalae is less than commonly thought or that systemic doses are too low in their local concentration .
BACKGROUND	To test the latter , we evaluated the effects of intramyocardial sevoflurane delivery .
METHODS	Selective myocardial sevoflurane delivery was performed during aortic cross-clamping in patients undergoing valve surgery ( n = 11 ) .
METHODS	Results were compared with a control group not receiving sevoflurane ( n = 10 ) .
METHODS	A reference group ( n = 5 ) was added to evaluate the effects of systemic sevoflurane delivery .
METHODS	Paired arterial and myocardial venous blood samples were collected at various time points post-reperfusion .
METHODS	Inflammatory mediators and myocardial cell damage were studied .
RESULTS	Intramyocardial delivery was superior to systemic delivery in attenuation of interleukin-6 and interleukin-8 ( -44 % and -25 % , respectively ; both P = 0.001 ) .
RESULTS	Myocardial and systemic sevoflurane delivery effectively suppressed surgery-related inflammatory responses including postoperative C-reactive protein levels when compared with controls [ 63 ( 47-99 ) ( P = 0.01 ) and 58 ( 56-81 ) ( P = 0.04 ) compared with 107 ( 79-144 ) mg litre ( -1 ) ] .
RESULTS	Sevoflurane treatment did not reduce postoperative troponin T , creatine kinase , and creatine kinase-MB values .
CONCLUSIONS	This proof-of-concept study suggests that intramyocardial delivery compared with the systemic delivery of sevoflurane more strongly attenuates the systemic inflammatory response after cardiopulmonary bypass without reducing postoperative markers of myocardial cell damage .
BACKGROUND	Nederlands Trial Register NTR2089 .

###24834511
OBJECTIVE	To assess the long-term safety and efficacy of pramipexole as a once-daily ( q.d. ) extended-release oral formulation in early or advanced Parkinson 's disease ( PD ) .
METHODS	In two double-blind ( DB ) studies of early PD and one of advanced PD,active-treatment arms received pramipexole immediate release ( IR ) or extended release ( ER ) , with exposure lasting up to 33 weeks .
METHODS	In open-label ( OL ) extensions that followed immediately , subjects took ER q.d. for up to 80 weeks , with dosage adjustment permitted ( range 0.375-4 .5 mg q.d. ) .
RESULTS	Of 590 subjects completing an early-PD DB study , 511 entered the early-PD OL extension ; 408 completed it .
RESULTS	Reported adverse events ( AEs ) with incidence 10.0 % were somnolence ( 15.1 % ) , peripheral edema ( 11.7 % ) and back pain ( 10.6 % ) .
RESULTS	Of 465 subjects completing the advanced-PD DB study , 391 entered the advanced-PD OL extension ; 329 completed it .
RESULTS	Reported AEs with incidence 10.0 % were dyskinesia ( 27.4 % ) and somnolence ( 13.6 % ) .
RESULTS	Impulse control disorders were identified by semi-structured interview in 13 subjects ( 1.4 % of 902 ) .
RESULTS	In exploratory analyses , adjusted mean Unified Parkinson 's Disease Rating Scale ( UPDRS ) PartsII + III scores ( excluding ex-placebo recipients ) remained substantially improved from DB baseline scores prior to pramipexole introduction , at -6.6 and -6.3 points amongst ex-DB-ER and ex-DB-IR recipients after 113 weeks of pramipexole ( 33 DB plus 80 OL ) in early PD , and -11.5 and -9.1 after up to 113 weeks ( up to 33 DB plus 80 OL ) in advanced PD .
CONCLUSIONS	These results support the long-term safety and efficacy of pramipexole ER in early and advanced PD .
CONCLUSIONS	AEs were typical for dopaminergic medications , and UPDRS scores suggested sustained symptomatic benefit .

###25181766
OBJECTIVE	To examine the impact of telephone reinforcement ( TR ) on predictors of physical activity ( PA ) maintenance in older adults with osteoarthritis .
METHODS	Mixed effects modeling was conducted of data from a randomized PA trial that used negotiated maintenance contracts , supplemented by TR , to test impact of TR on barriers , decisional balance , and stage of change at multiple points in time .
RESULTS	Participants who were referred to a PA program and received TR improved the most in barriers and decisional balance .
RESULTS	Participants who negotiated a tailored maintenance contract but did not receive TR improved the most in stage .
CONCLUSIONS	TR appears to positively affect perceptions around engagement , whereas negotiation positively impacts PA behavior .
CONCLUSIONS	Further research should examine the effectiveness of specific PA maintenance strategies .

###24818861
OBJECTIVE	To explore the long-term outcomes of CONECSI ( COping with NEuropathiC Spinal cord Injury pain ) , a multidisciplinary cognitive behavioural treatment programme in persons with spinal cord injury .
METHODS	Long-term follow-up pre-post-intervention design .
METHODS	A total of 29 subjects with a spinal cord injury and chronic neuropathic pain from 4 Dutch rehabilitation centres .
METHODS	Primary outcomes were pain intensity and pain-related disability ( Chronic Pain Grade questionnaire ) .
METHODS	Secondary outcomes were mood ( Hospital Anxiety and Depression Scale ) , participation in activities ( Utrecht Activities List ) , and life satisfaction ( Life Satisfaction Questionnaire ) .
METHODS	Random coefficient analysis was used for the analyses of measurements before ( t1 ) , immediate post-intervention ( t2 ) , and 6 ( t3 ) , 9 ( t4 ) , and 12 ( t5 ) months follow-up .
RESULTS	The analyses showed significant improvements on pain intensity ( t1-t2 and t1-t5 ) and pain-related disability ( t1-t2 , t1-t4 , and t1-t5 ) , anxiety and participation in activities ( t1-t2 , t1-t3 , and t1-t5 ) .
CONCLUSIONS	This exploratory study suggests that a multidisciplinary cognitive behavioural programme might have lasting improvements on pain intensity , pain-related disability , anxiety , and participation in activities in people with chronic neuropathic spinal cord injury pain and highlights the potential of such programmes .

###25822050
OBJECTIVE	Although Black heterosexual men ( BHM ) in the United States rank among those most affected by HIV , research about how safer sex messages shape their safer sex behaviors is rare , highlighting the need for innovative qualitative methodologies such as critical discursive psychology ( CDP ) .
OBJECTIVE	This CDP study examined how : ( a ) BHM construct safer sex and masculinity ; ( b ) BHM positioned themselves in relation to conventional masculinity ; and ( c ) discursive context ( individual interview vs. focus group ) shaped talk about safer sex and masculinity .
METHODS	Data included individual interviews ( n = 30 ) and 4 focus groups ( n = 26 ) conducted with 56 self-identified Black/African American heterosexual men , ages 18 to 44 .
RESULTS	Analyses highlighted 5 main constructions : ( a ) condoms as signifiers of `` safe '' women ; ( b ) blaming women for STI/responsibility for safer sex ; ( c ) relationship/trust/knowledge ; ( d ) condom mandates ; and ( e ) public health safer sex .
RESULTS	Discourses positioned BHM in terms of conventional masculinity when talk denied men 's agency for safer sex and/or contraception , or positioned women as deceitful , or apathetic about sexual risk and/or pregnancy .
RESULTS	Notably , discourses also spotlighted alternative masculinities relevant to taking responsibility for safer sex or sexual exclusivity .
RESULTS	Discursive context , namely the homosocial nature of focus group discussions , shaped how participants conversed about safer sex , and masculinity but not the content of that talk .
CONCLUSIONS	In denying BHM 's responsibility for safer sex , BHM 's discourses about safer sex and masculinity often mirror public health messages , underscoring a critical need to sync these discourses to reduce sexual risk , and develop gender-transformative safer sex interventions for BHM .

###25266608
BACKGROUND	Exercise has been shown to attenuate cigarette cravings during temporary smoking abstinence ; however , the mechanisms of action are not clearly understood .
OBJECTIVE	The objectives of the study were to compare the effects of three exercise intensities on desire to smoke and explore potential neurobiological mediators of desire to smoke .
METHODS	Following overnight abstinence , 40 participants ( 25 males , 18-59 years ) completed three 15 min sessions of light - , moderate - , or vigorous-intensity exercise on a cycle ergometer in a randomized crossover design .
METHODS	Ratings of desire to smoke were self-reported pre - and post-exercise and heart rate variability was measured throughout .
METHODS	Saliva and blood were analyzed for cortisol and noradrenaline in a sub-sample .
RESULTS	Exercise influenced desire to smoke ( F [ 2 , 91 ] = 7.94 , p < 0.01 ) , with reductions greatest immediately after vigorous exercise .
RESULTS	There were also significant time x exercise intensity interaction effects for heart rate variability and plasma noradrenaline ( F [ 8 , 72 ] = 2.23 , p = 0.03 ) , with a bias in noradrenaline occurring between light and vigorous conditions ( adjusted mean difference [ SE ] = 2850 ng/ml [ 592 ] , p < 0.01 ) at 5 min post-exercise .
RESULTS	There was no interaction of time x exercise intensity for plasma and salivary cortisol levels .
CONCLUSIONS	These findings support the use of vigorous exercise to reduce cigarette cravings , showing potential alterations in a noradrenergic marker .

###24690430
OBJECTIVE	To investigate the pathogenesis of bloodstream infection by Staphylococcus epidermidis , using the molecular epidemiology , in high-risk neonates .
METHODS	We conducted a prospective study of a cohort of neonates with bloodstream infection using central venous catheters for more than 24h .
METHODS	`` National Healthcare Safety Network '' surveillance was conducted .
METHODS	Genotyping was performed by DNA fingerprinting and mecA genes and icaAD were detected by multiplex-PCR .
RESULTS	From April 2006 to April 2008 , the incidence of bloodstream infection and central venous catheter-associated bloodstream infection was 15.1 and 13.0 / 1000 catheter days , respectively , with S. epidermidis accounting for 42.9 % of episodes .
RESULTS	Molecular analysis was used to document the similarity among six isolates of bloodstream infection by S. epidermidis from cases with positive blood and central venous catheter tip cultures .
RESULTS	Fifty percent of neonates had bloodstream infection not identified as definite or probable central venous catheter-related bloodstream infection .
RESULTS	Only one case was considered as definite central venous catheter-related bloodstream infection and was extraluminally acquired ; the remaining were considered probable central venous catheter-related bloodstream infections , with one probable extraluminally and another probable intraluminally acquired bloodstream infection .
RESULTS	Additionally , among mecA + and icaAD + samples , one clone ( A ) was predominant ( 80 % ) .
RESULTS	A polyclonal profile was found among sensitive samples that were not carriers of the icaAD gene .
CONCLUSIONS	The majority of infections caused by S. epidermidis in neonates had an unknown origin , although 33.3 % appeared to have been acquired intraluminally and extraluminally .
CONCLUSIONS	We observed a polyclonal profile between sensitive samples and a prevalent clone ( A ) between resistant samples .

###24855155
OBJECTIVE	We examined the effects of an intensive lifestyle intervention ( ILI ) , compared with a diabetes support and education ( DSE ) control intervention , on long-term changes in depression symptoms , antidepressant medication ( ADM ) use , and health-related quality of life ( HRQoL ) in overweight/obese individuals with type 2 diabetes .
METHODS	Look AHEAD was a multisite randomized controlled trial of 5,145 overweight/obese participants assigned to ILI ( designed to produce weight loss ) or DSE and followed for a median of 9.6 years .
METHODS	The Beck Depression Inventory ( BDI ) was administered at baseline , annually at years 1-4 , and again at year 8 .
METHODS	Mean BDI scores and incidence of BDI scores 10 , indicative of likely mild or greater depression , were examined .
METHODS	Annually through year 10 , participants reported their ADM use and completed the Medical Outcomes Study Short Form 36 ( SF-36 ) questionnaire , which yields physical component summary ( PCS ) and mental component summary ( MCS ) scores .
RESULTS	ILI significantly reduced the incidence of mild or greater depression symptoms ( BDI scores 10 ) compared with DSE ( hazard ratio [ HR ] = 0.85 ; 95 % CI 0.75-0 .97 ; P = 0.0145 ) .
RESULTS	Although SF-36 PCS scores worsened over time in both groups , ILI participants reported better physical function than DSE throughout the first 8 years ( all P values < 0.01 ) .
RESULTS	There were no significant differences between treatment arms in the proportion of participants who used ADMs or in SF-36 MCS scores .
CONCLUSIONS	ILI for overweight/obese patients with type 2 diabetes may reduce the risk of developing clinically significant symptoms of depression and preserve physical HRQoL .
CONCLUSIONS	These findings should be considered when evaluating the potential benefits of ILIs .

###25932839
OBJECTIVE	To evaluate whether manual or electric vacuum aspiration results in greater immediate confirmation of completed abortion at less than 6 weeks of gestation .
METHODS	Five hundred pregnant women presenting for surgical abortion with mean gestational sac diameter of less than 12 mm or no visible sac on ultrasonography were randomized to manual or electric vacuum aspiration .
METHODS	Tissue examination was performed by operating physicians , not blinded to group assignment , and by trained medical assistants , blinded to group assignment .
METHODS	Patients with no products of conception on gross inspection underwent repeat aspiration as necessary and serial human chorionic gonadotropin monitoring .
METHODS	All patients were scheduled for follow-up visits .
METHODS	The primary outcome was detection of products of conception in patients with subsequently confirmed completed abortion .
RESULTS	From April 2010 to October 2011 , 252 patients were randomized to manual vacuum aspiration and 248 to electric vacuum aspiration .
RESULTS	One hundred eighty-two ( 82 % ) patients in the manual vacuum aspiration group had products of conception identified and subsequently confirmed completed abortion compared with 164 ( 76 % ) patients undergoing electric vacuum patients ( P = .13 , relative risk 0.83 , 95 % confidence interval [ CI ] 0.64-1 .07 ) .
RESULTS	In pregnancies of sac size 3 mm or less , including no visible sac , five of 29 ( 17 % ) patients undergoing manual vacuum aspiration had accurate identification of products of conception compared with four of 31 ( 13 % ) patients undergoing electric vacuum aspiration ( P = .64 , relative risk 0.85 , 95 % CI 0.44-1 .63 ) .
RESULTS	Tissue reports of physicians and medical assistants had 90 % concordance .
RESULTS	Seventy-nine ( 16 % ) patients required human chorionic gonadotropin monitoring to confirm completed abortion .
RESULTS	There were seven ( 1.4 % ) ongoing pregnancies , including four false-positive products of conception results and , among the latter , one presumed ectopic pregnancy .
CONCLUSIONS	Our study supports providing abortions to women who request them before 6 weeks of gestation using either manual or electric vacuum aspiration .
CONCLUSIONS	Early aspiration is highly effective , although human chorionic gonadotropin monitoring may be necessary to confirm complete abortion .
METHODS	I.

###25452013
BACKGROUND	Neck pain is a common musculoskeletal complaint responsive to manual therapies .
BACKGROUND	Doctors of chiropractic commonly use manual cervical distraction , a mobilization procedure , to treat neck pain patients .
BACKGROUND	However , it is unknown if clinicians can consistently apply standardized cervical traction forces , a critical step toward identifying an optimal therapeutic dose .
OBJECTIVE	To assess clinicians ' proficiency in delivering manually applied traction forces within specified ranges to neck pain patients .
METHODS	An observational study nested within a randomized clinical trial .
METHODS	Two research clinicians provided study interventions to 48 participants with neck pain .
METHODS	Clinician proficiency in delivering cervical traction forces within three specified ranges ( low force , less than 20 N ; medium force , 21-50 N ; and high force 51-100 N ) .
METHODS	Participants were randomly allocated to three force-based treatment groups .
METHODS	Participants received five manual cervical distraction treatments over 2 weeks while lying prone on a treatment table instrumented with force sensors .
METHODS	Two clinicians delivered manual traction forces according to treatment groups .
METHODS	Clinicians treated participants first without real-time visual feedback displaying traction force and then with visual feedback .
METHODS	Peak traction force data were extracted and descriptively analyzed .
RESULTS	Clinicians delivered manual cervical distraction treatments within the prescribed traction force ranges 75 % of the time without visual feedback and 97 % of the time with visual feedback .
CONCLUSIONS	This study demonstrates that doctors of chiropractic can successfully deliver prescribed traction forces while treating neck pain patients , enabling the capability to conduct force-based dose response clinical studies .

###26148997
OBJECTIVE	To compare the perioperative outcomes of patients with primary hepatic carcinoma treated with laparoscopic hepatectomy ( LH ) with those treated with open hepatectomy ( OH ) .
METHODS	From January 2010 to August 2014 , 100 patients with primary hepatic carcinoma were randomly divided into the LH group and OH group respectively , 50 patients in each group .
METHODS	And the incision length , blood loss , operative time , postoperative liver function , anus exhaust time , complications , length of postoperative hospital stay , and cost measures were compared .
RESULTS	LH could achieve shorter incision length , less blood loss , more rapid recovery in liver function and gastrointestinal function , and shorter postoperative hospital stay length compared with OH for primary hepatic carcinoma patients ( all P < 0.05 ) .
RESULTS	However , LH could not significantly shorten operative time , and reduce postoperative complications and hospitalization cost ( all P > 0.05 ) .
CONCLUSIONS	Compared with OH , LH could improve perioperative outcomes of primary hepatic carcinoma patients .

###24392604
OBJECTIVE	To develop and validate a self-efficacy measure of diabetes self-management , the Lifestyle Self-Efficacy Scale for Latinos with Diabetes ( LSESLD ) , designed for low-income , Spanish-speaking Latinos with diabetes .
METHODS	Quantitative and qualitative methods .
METHODS	Community health centers in central and western Massachusetts .
METHODS	Low-income Latinos ( N = 252 ) enrolled in a randomized diabetes self-management intervention trial .
METHODS	Construct validity , internal consistency , sensitivity to change over time .
RESULTS	The LSESLD demonstrated good internal consistency ( Cronbach 's alpha = .85 ) , reasonable construct validity ( moderate , significant associations between the LSESLD and validated measures of diabetes knowledge , dietary intake , physical activity , blood glucose self-monitoring , and HbA1c values ) , and sensitivity to intervention-related changes over time .
CONCLUSIONS	The LSESLD is a reliable and valid research instrument assessing self-efficacy related to diabetes self-management among low-income , Spanish-speaking populations .

###24604835
BACKGROUND	Febrile neutropenia ( FN ) is a frequent , serious complication of intensive pediatric chemotherapy regimens .
BACKGROUND	The aim of this trial was to compare quality of life ( QOL ) between inpatient and outpatient intravenous antibiotic management of children and adolescents with low risk febrile neutropenia ( LRFN ) .
METHODS	In this randomised non-blinded trial , patients between 1 and 21 years old , receiving low/moderate intensity chemotherapy were pre-consented and , on presentation to emergency ( ED ) with FN satisfying low risk criteria , randomised to either outpatient or inpatient care with intravenous cefepime 50mg/kg ( 12 hourly ) .
METHODS	All patients continued antibiotics for at least 48hours , until afebrile for 24hours and demonstrating a rising absolute neutrophil count 200/mm ( 3 ) .
METHODS	Several domains of QOL were examined by daily questionnaire .
RESULTS	Eighty-one patients presented to ED with 159 episodes of fever .
RESULTS	Thirty-seven FN presentations involving 27 patients were randomised to inpatient ( 18 ) and outpatient ( 19 ) management .
RESULTS	Combined QOL mean scores for parents were higher for the outpatient group and scores for three specific parent variables ( keeping up with household tasks/time spent with partner/time spent with other children ) were higher among outpatients .
RESULTS	There was no difference in parent confidence/satisfaction in care between groups .
RESULTS	Patients scored better in the outpatient group overall and for sleep and appetite .
RESULTS	The mean length of fever was equivalent between groups and there were no serious adverse events attributable to cefepime or outpatient care .
CONCLUSIONS	Outpatient cefepime management of LRFN provided significant benefit to parents and patients across several QOL domains and appeared both feasible and safe .

###25417402
OBJECTIVE	To observe the effect of Liandouqingmai recipe ( Chinese herbal medicine compound preparation ) on the quality of life ( QOL ) and inflammatory reaction of patients with coronary heart disease ( CHD ) .
METHODS	A total of 101 CHD patients were randomized into two groups : treatment group ( n = 45 ) receiving standard treatment for CHD plus Liandouqingmai recipe , and control group ( n = 56 ) receiving standard treatment only .
METHODS	The control group contained 16 normal healthy subjects .
METHODS	Changes in hs-C-reactive protein ( CRP ) , peripheral blood leucocytes ( PBL ) , and interleukin ( IL ) -6 and IL-10 levels were measured .
METHODS	The Seattle Angina Questionnaire ( SAQ ) was used to determine patient QOL before and after treatment for 2 weeks .
RESULTS	Before treatment , SAQ scores [ physical limitation ( PL ) , angina stability ( AS ) , angina frequency ( AF ) , treatment satisfaction ( TS ) , and disease perception ( DP ) ] were not statistically different between groups .
RESULTS	After treatment , AS and DP levels of controls were significantly increased compared with the other groups , while PL , AS , AF , TS , and DP levels of the treatment group were significantly increased compared with controls .
RESULTS	Treatment group SAQ scores ( PL , AS , AF , TS , and DP ) were significantly higher than for controls .
RESULTS	CHD patient IL-6 and IL-10 levels were significantly higher than controls .
RESULTS	Before treatment , mean levels of IL-6 , hs-CRP and PBL of the two groups were not statistically different .
RESULTS	After treatment , mean levels of IL-6 , IL-10 , hs-CRP and PBL of the two groups were significantly decreased compared with their before treatment values , and levels of IL-6 , hs-CRP , and PBL of the treatment group were lower than controls .
RESULTS	Although mean IL-10 levels of both groups decreased , there was no significant difference in between-group and in-roup comparisons before and after treatment .
RESULTS	Mean levels of IL-6 and IL-10 in the normal group were lower than in CHD patients .
RESULTS	SAQ scores of QOL were negatively associated with the inflammatory index ( IL-6 / IL-10 ) , and there was a significant negative association of IL-10 with AS ( r = - 0.15 , P < 0.05 ) .
CONCLUSIONS	Inflammatory reactions in CHD patients are related to angina status .
CONCLUSIONS	Coadministration of CHD standard treatment and Liandouqingmai recipe increased patient SAQ scores by decreasing IL-6 , IL-10 , hs-CRP , and PBL levels in CHD patients , which might inhibit endothelial inflammation to improve patient QOL .

###25042878
OBJECTIVE	We investigated whether expression of epidermal growth factor receptor ( EGFR ) was associated with survival and disease control in this secondary analysis of a phase II trial of cetuximab + chemoradiation for stage III non-small cell lung cancer .
METHODS	Patients received cetuximab weekly before and during radiation ( 63 Gy/35 fractions/7 weeks ) with weekly carboplatin + paclitaxel .
METHODS	We analyzed EGFR expression by immunohistochemistry ( IHC ) and fluorescence in situ hybridization ( FISH ) in pretreatment biopsy specimens and compared findings with overall and progression-free survival ( OS , PFS ) and time to progression ( TTP ) .
RESULTS	Specimens for IHC and FISH were collected from 51 and 45 of 87 evaluable patients .
RESULTS	Pretreatment characteristics did not differ for patients with ( n = 51 ) or without ( n = 36 ) EGFR IHC data , or with ( n = 45 ) or without ( n = 42 ) FISH data .
RESULTS	However , patients without IHC data had worse OS ( HR = 1.63 , P = 0.05 ) , worse PFS ( HR = 1.88 , P = 0.008 ) , and worse TTP [ HR = 1.99 , P = 0.01 ] than those with IHC data .
RESULTS	EGFR protein expression was not related to pretreatment characteristics or OS ; FISH-positive disease was associated with better performance status but not with OS , PFS , or TTP .
CONCLUSIONS	Surprisingly , outcomes differed not by EGFR expression but by the availability of samples for analysis , underscoring the importance of obtaining biopsy samples in such trials .

###24760263
OBJECTIVE	To assess the efficacy of in-shoe orthoses that were designed based on shape and barefoot plantar pressure in reducing the incidence of submetatarsal head plantar ulcers in people with diabetes , peripheral neuropathy , and a history of similar prior ulceration .
METHODS	Single-blinded multicenter randomized controlled trial with subjects randomized to wear shape - and pressure-based orthoses ( experimental , n = 66 ) or standard-of-care A5513 orthoses ( control , n = 64 ) .
METHODS	Patients were followed for 15 months , until a study end point ( forefoot plantar ulcer or nonulcerative plantar forefoot lesion ) or to study termination .
METHODS	Proportional hazards regression was used for analysis .
RESULTS	There was a trend in the composite primary end point ( both ulcers and nonulcerative lesions ) across the full follow-up period ( P = 0.13 ) in favor of the experimental orthoses .
RESULTS	This trend was due to a marked difference in ulcer occurrence ( P = 0.007 ) but no difference in the rate of nonulcerative lesions ( P = 0.76 ) .
RESULTS	At 180 days , the ulcer prevention effect of the experimental orthoses was already significant ( P = 0.003 ) when compared with control , and the benefit of the experimental orthoses with respect to the composite end point was also significant ( P = 0.042 ) .
RESULTS	The hazard ratio was 3.4 ( 95 % CI 1.3-8 .7 ) for the occurrence of a submetatarsal head plantar ulcer in the control compared with experimental arm over the duration of the study .
CONCLUSIONS	We conclude that shape - and barefoot plantar pressure-based orthoses were more effective in reducing submetatarsal head plantar ulcer recurrence than current standard-of-care orthoses , but they did not significantly reduce nonulcerative lesions .

###24458074
OBJECTIVE	Inflammation and malnutrition are important features in patients with ESRD ; however , data on changes in these parameters over time are scarce .
OBJECTIVE	This study aimed to gain insight into changes over time in serum albumin , body mass index , high-sensitivity C-reactive protein , and IL-6 in patients with ESRD and aimed to identify clinical risk factors for deterioration of these parameters .
METHODS	Data were analyzed from the Convective Transport Study , a randomized controlled trial conducted from June 2004 to January 2011 , in which 714 patients with chronic ESRD were randomized to either online hemodiafiltration or low-flux hemodialysis .
METHODS	Albumin and body mass index were measured up to 6 years and predialysis C-reactive protein and IL-6 were measured up to 3 years in a subset of 405 participants .
METHODS	Rates of change in these parameters over time were estimated across strata of predefined risk factors with linear mixed-effects models .
RESULTS	Albumin and body mass index decreased and C-reactive protein and IL-6 increased over time .
RESULTS	For every incremental year of age at baseline , the yearly excess decline in albumin was 0.003 g/dl ( -0.004 to -0.002 ; P < 0.001 ) and the excess decline in body mass index was 0.02 kg/m ( 2 ) per year ( -0.02 to -0.01 ; P < 0.001 ) .
RESULTS	In patients with diabetes mellitus , there was a yearly excess decline of 0.05 g/dl in albumin ( -0.09 to -0.02 ; P = 0.002 ) .
RESULTS	Compared with women , men had an excess decline of 0.03 g/dl per year in albumin ( -0.06 to -0.001 ; P = 0.05 ) and an excess increase of 11.6 % per year in IL-6 ( 0.63 % -23.6 % ; P = 0.04 ) .
CONCLUSIONS	Despite guideline-based care , all inflammatory and nutritional parameters worsened over time .
CONCLUSIONS	The deterioration of some of these parameters was more pronounced in men , older patients , and patients with diabetes mellitus .
CONCLUSIONS	Special focus on the nutritional status of at-risk patients by individualizing medical care might improve their prognosis .

###26121878
OBJECTIVE	To investigate the efficacy and safety of domestic tiotropium inhalation capsule in patients with chronic obstructive pulmonary disease ( COPD ) with multi-center randomized clinical trial .
METHODS	Patients with stable slight to moderate COPD were randomized into trial group ( n = 109 ) with tiotropium 18 pg Qd or control group ( n = 111 ) with ipratropium 40 g Qid for a treatment of four weeks .
METHODS	The spirometry and scoring questionaire were recorded at different visits during the treatment .
METHODS	Rescue medication consumption and adverse events were recorded .
METHODS	Results Forced expiratory volume in 1 s ( FEV1 ) of both groups increased obviously 30 min and 3 h after first dosing .
METHODS	After four weeks treatments , FEV , and forced vital capacity ( FVC ) in both groups were improved obviously , and the improvement in tiotropium group was significantly higher than that ipratropium group .
METHODS	COPD symptom scores were significantly reduced in both groups , and the improvement in tiotropium group was significantly better than that in ipratropium group .
METHODS	There was no significant difference in rescue medication consumption between the two groups .
METHODS	The ratios of adverse events were 22.02 % and 15.32 % in tiotropium and ipratropium group , respectively ( P = 0.23 ) .
CONCLUSIONS	Domestic tiotropium inhalation capsule is efficient and safe in the treatment of COPD .

###24386927
BACKGROUND	Telephone-delivered interventions to provide health counseling for complex chronic medical conditions are convenient , acceptable , and cost-effective .
BACKGROUND	However , little is known about which patients are reached , their characteristics , and who benefits most from telephone-delivered counseling .
METHODS	This study examined whether baseline characteristics are predictive of being easily reached for a monthly , telephone-delivered behavioral intervention to improve treatment adherence in Veterans with uncontrolled hypertension .
METHODS	Participants were to complete a telephone session once a month for 6 months .
RESULTS	Participants completed an average of 5.71 out of a possible 6 sessions .
RESULTS	Participants who were unmarried , African American , unemployed , or younger or did not complete high school required significantly more call attempts per completed session .
CONCLUSIONS	Overall , telephone-delivered counseling is a feasible approach to reaching hypertensive patients .
CONCLUSIONS	Patients who are married , Hispanic , retired , or older or graduated college may be easier to reach and engage in telephone-delivered counseling .
CONCLUSIONS	Reaching patients with other sociodemographic characteristics may require more resources or alternate methods .

###24474079
OBJECTIVE	Noninvasive mechanical ventilation during the postoperative period ( PO ) following lung resection can restore residual functional capacity , improve oxygenation and spare the inspiratory muscles .
OBJECTIVE	The objective of this study was to assess the efficacy of continuous positive airway pressure ( CPAP ) associated with physiotherapy , compared with physiotherapy alone after lung resection .
METHODS	Open randomized clinical trial conducted in the clinical hospital of Universidade Estadual de Campinas .
METHODS	Sessions were held in the immediate postoperative period ( POi ) and on the first and second postoperative days ( PO1 and PO2 ) , and the patients were reassessed on the discharge day .
METHODS	CPAP was applied for two hours and the pressure adjustment was set between 7 and 8.5 cmH2O .
METHODS	The oxygenation index ( OI ) , Borg scale , pain scale and presence of thoracic drains and air losses were evaluated .
RESULTS	There was a significant increase in the OI in the CPAP group in the POi compared to the Chest Physiotherapy ( CP ) group , P = 0.024 .
RESULTS	In the CP group the OI was significantly lower on PO1 ( P = 0,042 ) , than CPAP group .
RESULTS	The air losses were significantly greater in the CPAP group in the POi and on PO1 ( P = 0.001 , P = 0.028 ) , but there was no significant difference between the groups on PO2 and PO3 .
RESULTS	There was a statistically significant difference between the groups regarding the Borg scale in the POi ( P < 0.001 ) , but there were no statistically significant differences between the groups regarding the pain score .
CONCLUSIONS	CPAP after lung resection is safe and improves oxygenation , without increasing the air losses through the drains .
BACKGROUND	NCT01285648 .

###25289711
OBJECTIVE	The aim of this study was to investigate the effect of acute L-carnitine supplementation at two different doses on nitric oxide ( NO ) production and oxidative stress after exhaustive exercise .
METHODS	The subjects were 26 healthy males aged 17-19 years .
METHODS	Subjects were randomly divided into two groups of 13 each and received 3 or 4 g L-carnitine via a glass of fruit juice .
METHODS	After 1 h , the treadmill test was started at a speed of 8 km/h , afterwards increasing the speed 1 km/h every 3 min with a 1 min rest before every speed increase until exhaustion .
METHODS	Venous blood samples were collected again within 5 min following the exercise test .
METHODS	One week later , the test was repeated on the same athletes with placebo fluids .
METHODS	All subjects received a placebo via a glass of fruit juice .
METHODS	1 h after the same exercise protocol mentioned above was performed and blood samples were drawn immediately .
METHODS	These plasma samples were used for measurement of nitrate-nitrite ( NOx ) , which are known to be the stable end products of NO , TBARs as a lipid peroxidation indicator and an antioxidant glutathione ( GSH ) levels .
CONCLUSIONS	The results of this study have shown that L-carnitine applied at a 3 g dose provides strong antioxidant action by increasing the GSH and NOx level and decreasing the TBARs level .

###24236667
OBJECTIVE	Treatment of patients with single-segment degenerative lumbar instability using unilateral pedicle screw fixation can achieve stability and fusion rates similar to those of bilateral pedicle screw fixation .
OBJECTIVE	The aim of this study was to analyze the clinical outcome of using unilateral pedicle screw fixation through a tubular retractor via the Wiltse approach to treat single-segment degenerative lumbar instability .
METHODS	Thirty-nine consecutive patients with single-segment , low-grade , degenerative lumbar instability were randomly assigned to treatment with either unilateral ( n = 20 ) or bilateral ( n = 19 ) pedicle screw fixation .
METHODS	In the unilateral group , patients underwent unilateral posterior lumbar interbody fusion ( PLIF ) and ipsilateral pedicle screw fixation through a tubular retractor via the Wiltse approach .
METHODS	In the bilateral group , patients underwent modified bilateral PLIF with bilateral pedicle screw fixation via the posterior midline approach .
METHODS	During follow-up , patients were evaluated using a visual analog scale ( VAS ) , the Japanese Orthopaedic Association ( JOA ) score , and the Oswestry Disability Index .
RESULTS	The unilateral group had a shorter operative duration ( p < 0.05 ) and less blood loss ( p < 0.001 ) .
RESULTS	All patients completed more than 2 years of follow-up ( mean 36 months ) .
RESULTS	In general , the time trends in improvement on the VAS and JOA differed slightly between the groups through 2 years , but no significant difference in back pain VAS score or leg pain VAS score was found between these 2 groups at the 2-year follow-up .
RESULTS	Complete bone fusion was shown on CT in all patients at the 2-year follow-up .
CONCLUSIONS	Unilateral pedicle screw fixation through a tubular retractor via the Wiltse approach appears to be as safe and effective as bilateral pedicle screw fixation for the treatment of single-segment degenerative lumbar instability .

###24373369
OBJECTIVE	To study the effects of both balneotherapy and mud-bath therapy treatments in patients affected by primary fibromyalgia ( FM ) using rheumatological , psychiatric , biochemical and proteomic approaches .
METHODS	Forty-one FM patients ( 39 females , 2 males ) , who fulfilled the American College of Rheumatology criteria received a 2-week thermal therapy programme consisting of therapy once daily for 6 days/week .
METHODS	Twenty-one patients received mud-bath treatment , while the other twenty balneotherapy .
METHODS	Pain , symptoms , and quality of life were assessed .
METHODS	Oxytocin , brain-derived neurotrophic factor ( BDNF ) , ATP and serotonin transporter levels during therapy were assayed .
METHODS	Comparative whole saliva ( WS ) proteomic analysis was performed using a combination of two-dimensional electrophoresis ( 2DE ) and mass spectrometry techniques .
RESULTS	We observed a reduction in pain , FIQ values and improvement of SF36 in both groups of patients treated with mud-bath or balneotherapy .
RESULTS	The improvement of the outcome measures occurred with different timing and duration in the two spa treatments .
RESULTS	A significant decrease in BDNF concentrations was observed either after balneotherapy or mud-bath therapy when assayed after twelve weeks , while no significant change in oxytocin levels , ATP levels and serotonin transporter were detected .
RESULTS	Significant differences were observed for phosphoglycerate mutase1 ( PGAM1 ) and zinc alpha-2-glycoprotein 1 ( AZGP1 ) protein expression .
CONCLUSIONS	Our results showed that the thermal treatment might have a beneficial effect on the specific symptoms of the disease .
CONCLUSIONS	In particular , while balneotherapy gives results that in most patients occur after the end of the treatment but which are no longer noticeable after 3 months , the mud-bath treatment gives longer lasting results .

###24907877
OBJECTIVE	Success rate of catheter applications is low in supraclavicular block .
OBJECTIVE	Thus , bupivacaine and levobupivacaine become important with their long effect time in single injection practices .
OBJECTIVE	In this study , we aimed to compare the effectiveness , side effects and complications of bupivacaine and levobupivacaine in supraclavicular block .
METHODS	Sixty patients aged between 20 and 65 , with body weight between 50 and 100 kg , in the ASA I-II-III group who were scheduled for hand , forearm and arm surgery using supraclavicular block were randomized into two groups of 30 .
METHODS	The patients received 30 ml 0.5 % bupivacaine ( Group B ) or 30 ml 0.5 % levobupivacaine ( Group L ) .
METHODS	Motor and sensory blocks were evaluated .
METHODS	Motor and sensory block onset times , total block durations , postoperative pain , amount of postoperative analgesic used and patient satisfaction were recorded .
RESULTS	Demographic data , distribution of surgical area and hemodynamic data were similar between the two groups .
RESULTS	Surgery , motor and sensory block durations of Group B and L patients did not vary statistically significantly .
RESULTS	However , motor and sensory block onset times in Group B were significantly shorter than Group L ( p < 0.05 ) .
RESULTS	The mean time for first postoperative analgesic demand were 16.6 8.0 h in Group B and 14.4 7.3 h in Group L ( p > 0.05 ) .
CONCLUSIONS	30 ml 0.5 % bupivacaine and levobupivacaine provide similar block characteristics for supraclavicular block .
CONCLUSIONS	Bupivacaine leads to faster motor and sensory block onset compared to levobupivacaine however similar duration of postoperative analgesia .

###25498218
BACKGROUND	Patients with muscle-invasive urothelial carcinoma of the bladder have poor survival after cystectomy .
BACKGROUND	The EORTC 30994 trial aimed to compare immediate versus deferred cisplatin-based combination chemotherapy after radical cystectomy in patients with pT3-pT4 or N + M0 urothelial carcinoma of the bladder .
METHODS	This intergroup , open-label , randomised , phase 3 trial recruited patients from hospitals across Europe and Canada .
METHODS	Eligible patients had histologically proven urothelial carcinoma of the bladder , pT3-pT4 disease or node positive ( pN1-3 ) M0 disease after radical cystectomy and bilateral lymphadenectomy , with no evidence of any microscopic residual disease .
METHODS	Within 90 days of cystectomy , patients were centrally randomly assigned ( 1:1 ) by minimisation to either immediate adjuvant chemotherapy ( four cycles of gemcitabine plus cisplatin , high-dose methotrexate , vinblastine , doxorubicin , and cisplatin [ high-dose MVAC ] , or MVAC ) or six cycles of deferred chemotherapy at relapse , with stratification for institution , pT category , and lymph node status according to the number of nodes dissected .
METHODS	Neither patients nor investigators were masked .
METHODS	Overall survival was the primary endpoint ; all analyses were by intention to treat .
METHODS	The trial was closed after recruitment of 284 of the planned 660 patients .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00028756 .
RESULTS	From April 29 , 2002 , to Aug 14 , 2008 , 284 patients were randomly assigned ( 141 to immediate treatment and 143 to deferred treatment ) , and followed up until the data cutoff of Aug 21 , 2013 .
RESULTS	After a median follow-up of 7.0 years ( IQR 5.2-8 .7 ) , 66 ( 47 % ) of 141 patients in the immediate treatment group had died compared with 82 ( 57 % ) of 143 in the deferred treatment group .
RESULTS	No significant improvement in overall survival was noted with immediate treatment when compared with deferred treatment ( adjusted HR 0.78 , 95 % CI 0.56-1 .08 ; p = 0.13 ) .
RESULTS	Immediate treatment significantly prolonged progression-free survival compared with deferred treatment ( HR 0.54 , 95 % CI 0.4-0 .73 , p < 0.0001 ) , with 5-year progression-free survival of 47.6 % ( 95 % CI 38.8-55 .9 ) in the immediate treatment group and 31.8 % ( 24.2-39 .6 ) in the deferred treatment group .
RESULTS	Grade 3-4 myelosuppression was reported in 33 ( 26 % ) of 128 patients who received treatment in the immediate chemotherapy group versus 24 ( 35 % ) of 68 patients who received treatment in the deferred chemotherapy group , neutropenia occurred in 49 ( 38 % ) versus 36 ( 53 % ) patients , respectively , and thrombocytopenia in 36 ( 28 % ) versus 26 ( 38 % ) .
RESULTS	Two patients died due to toxicity , one in each group .
CONCLUSIONS	Our data did not show a significant improvement in overall survival with immediate versus deferred chemotherapy after radical cystectomy and bilateral lymphadenectomy for patients with muscle-invasive urothelial carcinoma .
CONCLUSIONS	However , the trial is limited in power , and it is possible that some subgroups of patients might still benefit from immediate chemotherapy .
CONCLUSIONS	An updated individual patient data meta-analysis and biomarker research are needed to further elucidate the potential for survival benefit in subgroups of patients .
BACKGROUND	Lilly , Canadian Cancer Society Research .

###24464845
OBJECTIVE	Continuous-flow left ventricular assist device ( CF-LVAD ) implantation is associated with improved quality of life , but the effect on exercise capacity is less well documented .
OBJECTIVE	It is uncertain whether a fixed CF-LVAD pump speed , which allows for sufficient circulatory support at rest , remains adequate during exercise .
OBJECTIVE	The aim of this study was to evaluate the effects of fixed versus incremental pump speed on peak oxygen uptake ( peak VO2 ) during a maximal exercise test .
RESULTS	In CF-LVAD ( HeartMate II ) patients exercise testing measuring peak oxygen uptake ( VO2 ) was performed on an ergometer bike twice in one day : once with fixed pump speed ( testfix ) and once with incremental pump speed ( testinc ) .
RESULTS	The order of testfix and testinc in each patient was determined by randomization .
RESULTS	During testinc pump speed was increased from the baseline value by 400rpm/2min .
RESULTS	Fourteen patients ( aged 2369years ) were included with a mean support duration of 465483days .
RESULTS	Baseline CF-LVAD speed was 9357238rpm and during testinc speed was increased by a mean of 1486775rpm .
RESULTS	Mean peak VO2 was significantly higher in testinc compared with testfix ( 15.45.9 mL/kg/min vs. 14.16.3 mL/kg/min ; P = 0.012 ) , corresponding to a 9.2 % increase .
RESULTS	All exercise tests ( n = 28 ) were adequately performed with RER > 1 .
CONCLUSIONS	Increasing pump speed during exercise augments peak VO2 in patients supported with CF-LVADs .
CONCLUSIONS	An automatic speed-change function in future generations of CF-LVADs might improve functional capacity .

###24692480
OBJECTIVE	The results of previous studies suggest that early goal-directed fluid therapy ( EGDT ) reduces delayed cerebral ischemia ( DCI ) after aneurysmal subarachnoid hemorrhage , but the effects of EGDT on clinical outcomes are still unclear .
OBJECTIVE	This study aimed to determine whether EGDT improves outcomes compared with standard less-invasive hemodynamic therapy .
METHODS	This study included 160 patients treated within 24 hours after subarachnoid hemorrhage , randomized to receive either ( 1 ) EGDT guided by preload volume and cardiac output monitored by transpulmonary thermodilution ( treatment group ) or ( 2 ) standard therapy guided by fluid balance or central venous pressure , assisted by uncalibrated less-invasive cardiac output monitoring during hyperdynamic therapy in patients with clinical or radiological indications of DCI ( control group ) .
METHODS	DCI determined by clinical or radiological findings and functional outcome determined by the modified Rankin Scale score at 3 months were compared between groups .
RESULTS	For all clinical grades combined , there were no significant differences in the rates of DCI ( 33 % versus 42 % ; P = 0.33 ) or modified Rankin Scale score of 0 to 3 at 3 months ( 67 % versus 57 % ; P = 0.22 ) between the 2 groups .
RESULTS	For patients with poor clinical grade , those who received EGDT had a significantly lower rate of DCI ( 5 % versus 14 % ; P = 0.036 ) , modified Rankin Scale score of 0 to 3 at 3 months ( 52 % versus 36 % ; P = 0.026 ) , and shorter length of intensive care unit stay ( 14 versus 17 days ; P = 0.043 ) than those who received standard therapy .
CONCLUSIONS	EGDT is beneficial for reducing DCI and improving postoperative functional outcome in patients with poor clinical grade .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : UMIN000007509 .

###25147328
OBJECTIVE	Higher low-density lipoprotein cholesterol is associated with more rapid chronic kidney disease progression ; reduction in cholesterol with statins , in conjunction with statins ' pleiotropic effects , such as decreasing inflammation , may be renoprotective .
OBJECTIVE	The Stroke Prevention by Aggressive Reduction in Cholesterol Levels ( SPARCL ) trial assessed the effect of statin treatment on the risk of nonfatal and fatal stroke in subjects with a noncardioembolic stroke or transient ischemic attack , no known coronary heart disease , and low-density lipoprotein cholesterol between 2.6 and 4.9 mmol/L ( 100-190 mg/dL ) .
METHODS	We explored the effect of randomization to atorvastatin 80 mg/d or placebo on the change in estimated glomerular filtration rate ( eGFR ; using the 4-component Modification of Diet in Renal Disease Study equation ) in SPARCL subjects ( n = 4731 ) with ( eGFR , < 60 mL/min per 1.73 m2 ; n = 3119 ) and without ( eGFR , 60 mL/min per 1.73 m2 ; n = 1600 ) chronic kidney disease overall and by glycemic status at baseline .
RESULTS	Mean baseline eGFR was similar between treatment groups ( 65.50.26 versus 65.60.26 mL/min per 1.73 m2 atorvastatin versus placebo ; 33 % versus 34 % had chronic kidney disease , respectively ; P = 0.55 ) .
RESULTS	After 60 months , eGFR increased 3.460.33 mL/min per 1.73 m2 in those randomized to atorvastatin versus 1.420.34 mL/min per 1.73 m2 in those randomized to placebo ( P < 0.001 ) independent of baseline renal function .
RESULTS	In the subgroup with diabetes mellitus at randomization , eGFR increased 1.120.92 mL/min per 1.73 m2 in the atorvastatin group and decreased 1.690.92 mL/min per 1.73 m2 in placebo group during a period of 60 months ( P = 0.016 ) .
CONCLUSIONS	This post hoc analysis suggests that atorvastatin treatment may improve renal function in patients with prior stroke or transient ischemic attack with and without chronic kidney disease , and that atorvastatin treatment may prevent eGFR decline in patients with stroke and diabetes mellitus .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00147602 .

###24946811
BACKGROUND	Fluralaner , a novel isoxazoline , has both acaricidal and insecticidal activity through potent blockage of GABA - and L-glutamate-gated chloride channels .
BACKGROUND	This study investigated the in vitro and in vivo effects of fluralaner exposure on flea ( Ctenocephalides felis ) reproduction .
METHODS	Blood spiked with sub-insecticidal fluralaner concentrations ( between 0.09 and 50.0 ng/mL ) was fed to fleas for 10 days using a membrane system .
METHODS	Cessation of reproduction in exposed fleas was assessed using flea survival , egg hatchability , and control of oviposition , pupae , and flea emergence .
METHODS	Fluralaner efficacy for in vivo Ctenocephalides ( C. ) felis control on dogs was assessed using a simulated flea-infested home environment .
METHODS	During a pre-treatment period , dogs were infested twice on days -28 and -21 with 100 adult unfed fleas to establish a thriving population by day 0 of the study .
METHODS	On day 0 , one group of dogs was treated with fluralaner ( Bravecto ; n = 10 ) , while another group served as negative control ( n = 10 ) .
METHODS	Following treatment , dogs were infested three times with 50 fleas on days 22 , 50 and 78 to simulate new infestations .
METHODS	Live flea counts were conducted weekly on all dogs for 12 weeks starting 1 day before treatment .
RESULTS	Fluralaner potently inhibited flea reproduction capacity in vitro .
RESULTS	Oviposition ceased completely at concentrations as low as 25.0 ng/mL .
RESULTS	While no ovicidal effect was observed , fluralaner exerted a larvicidal effect at exceptionally low concentrations ( 6.25 ng/mL ) .
RESULTS	In the simulated flea-infested home environment , flea-control efficacy on fluralaner-treated dogs was > 99 % at every time point measured for 12 weeks .
RESULTS	No adverse events were observed in fluralaner-treated dogs .
CONCLUSIONS	Fluralaner completely controls egg laying , larval development and flea reproduction even at sub-insecticidal concentrations .
CONCLUSIONS	Oral treatment of dogs with fluralaner is highly effective for eliminating fleas in a simulated flea-infested home environment .

###24503176
BACKGROUND	It is difficult to improve negative symptoms and cognitive impairments in schizophrenia .
BACKGROUND	A previous pilot study has shown that minocycline , a semi-synthetic second-generation tetracycline , is effective in treating for negative and/or cognitive symptoms in schizophrenia .
OBJECTIVE	The present study was designed to examine the efficacy and safety of minocycline for the treatment of negative symptoms and cognitive impairments in patients with schizophrenia .
METHODS	Ninety-two patients with early stage schizophrenia treated with risperidone entered this 16-week , double blind , randomized , placebo-controlled clinical trial .
METHODS	Subjects were randomly assigned to receive minocycline ( 200mg per day ) or the placebo .
METHODS	The primary outcome was evaluated using the Scale for the Assessment of Negative Symptoms ( SANS ) .
METHODS	Secondary outcomes included the response rate of SANS , the Positive and Negative Syndrome Scale ( PANSS ) , the Clinical Global Impression Scale ( CGI ) , and cognitive tests .
RESULTS	Subjects receiving minocycline had greater improvements on SANS total scores and PANSS negative subscale scores ( P < 0.001 ) when compared with those receiving the placebo .
RESULTS	Rates of treatment response ( 43.6 % ) in the minocycline group were significantly higher than those in the placebo group ( 10.0 % ) after 16weeks of treatment .
RESULTS	There was no significant difference between the seven cognitive domains ( P > 0.05 ) , except for the attention domain ( P = 0.044 ) .
CONCLUSIONS	The addition of minocycline to atypical antipsychotic drugs in early schizophrenia had significant efficacy on negative symptoms but had a slight effect on the attention domains of patients with schizophrenia .
CONCLUSIONS	It may be considered as a new adjunct treatment for negative symptoms of schizophrenia .
CONCLUSIONS	Clinical trials.gov identifier : NCT01493622 .

###24372700
BACKGROUND	Advance care planning ( ACP ) provides patients with the ability to make their decisions known about how they would like to be treated if they lose capacity .
BACKGROUND	Medical practitioners have a key role to play in providing information on ACP to their patients .
BACKGROUND	This research explores their knowledge and attitudes to advance care planning and how this affects their practice .
OBJECTIVE	The objective of this study is to assess the NSW medical practitioners ' knowledge and self-reported practice of ACP .
METHODS	A postal survey of a random sample of 650 general practitioners plus 350 medical specialists from specialties most often involved in end-of-life decisions was conducted .
METHODS	Respondents ' work location post codes were subsequently used to assign respondents to one of the eight NSW Area Health Services .
METHODS	The main outcome measures were medical practitioners ' knowledge of and practice pertaining to ACP .
RESULTS	Thirty-four per cent of specialists ( n = 110 ) and 24 % of general practitioners ( n = 150 ) responded ; the majority of respondents had heard of all ACP options .
RESULTS	However , respondents ' understanding of the uses and legal requirements of the relevant ACP options vary widely .
CONCLUSIONS	Respect for patient wishes expressed in advance directives is reassuringly high .
CONCLUSIONS	The findings suggest significant misunderstanding by medical practitioners of terminologies and systems around substitute decision-making for incompetent persons .
CONCLUSIONS	Further education and standardisation of terminologies and systems across different jurisdictions would assist in addressing these issues .
CONCLUSIONS	Low response rate , relating to only one legal jurisdiction , means results may not be generalisable .

###24354454
OBJECTIVE	The aim of this single - blind , multicenter , parallel , randomized controlled trial was to evaluate the effectiveness of the application of a high-fluoride toothpaste on root caries in adults .
METHODS	Adult patients ( n = 130 , = 74 , = 56 ; mean age SD : 56.9 12.9 ) from three participating centers , diagnosed with root caries , were randomly allocated into two groups : Test ( n = 64 , = 37 , = 27 ; lesions = 144 ; mean age : 59.0 12.1 ; intervention : high-fluoride toothpaste with 5000 ppm F ) , and Control ( n = 66 , = 37 , = 29 ; lesions = 160 ; mean age : 54.8 13.5 ; intervention : regular-fluoride toothpaste with 1350 ppm F ) groups .
METHODS	Clinical examinations and surface hardness scoring of the carious lesions were performed for each subject at specified time intervals ( T0 - at baseline before intervention , T1 - at 3 months and T2 - at 6 months after intervention ) .
METHODS	Mean surface hardness scores ( HS ) were calculated for each patient .
METHODS	Statistical analyses comprised of two-way analysis of variance and post hoc comparisons using the Bonferroni-Dunn correction .
RESULTS	At T0 , there was no statistical difference between the two groups with regard to gender ( P = 0.0682 , unpaired t-test ) , or age ( P = 0.9786 , chi-squared test ) , and for the overall HS ( Test group : HS = 3.4 0.61 ;
METHODS	HS = 3.4 0.66 ; P = 0.8757 , unpaired t-test ) .
METHODS	The anova revealed significantly better HS for the test group than for the control groups ( T1 : Test group : HS = 2.9 0.67 ;
METHODS	HS = 3.1 0.75 ; T2 : Test group : HS = 2.4 0.81 ;
METHODS	HS = 2.8 0.79 ; P < 0.0001 ) .
METHODS	However , the interaction term time-point * group was not significant .
CONCLUSIONS	The application of a high-fluoride containing dentifrice ( 5000 ppm F ) in adults , twice daily , significantly improves the surface hardness of otherwise untreated root caries lesions when compared with the use of regular fluoride containing ( 1350 ppm F ) toothpastes .

###24228540
OBJECTIVE	Study on quality of life of asymptomatic HIV infected persons with traditional Chinese medical , which can provide the clinical basis for improving the quality of life .
METHODS	This study applied a randomized , double-blind , and placeb-parallel control designed method to select 1 200 persons in the asymptomatic period of HIV infection as the subjects .
METHODS	The subjects were randomly divided into the treatment group and the control group at the ratio of about 2:1 .
METHODS	According to the results of monthly differential diagnosis of TCM , the test group and the control group were given homologue Chinese drugs preparations and model Chinese drugs .
METHODS	The total study period was 18 months .
METHODS	Using PRO scale and the world health organization AIDS determination of quality of life short scale form ( WHOQOL-HIV-BREF ) to investigate asymptomatic HIV infected persons , according to different times , we calculated the total score and each domain score of quality of life of the treatment group and control group , we did statistical analysis .
RESULTS	Form the PRO scale , we can see that the treatment group showed a trend of stability , compared with the control group with significant statistical difference ( P < 0.05 ) after 6 months ; from the WHOQOL-HIV scale analysis , we can see that compared with before treatment , the quality of life of the treatment group was increased , the difference was significant ( P < 0.05 ) , but the quality of life of the control quality of life was decreased , the differences was significant ( P < 0.05 ) .
CONCLUSIONS	Dialectical therapy of Chinese medicine can significantly improve the patient 's quality of life , which can provide the basis for the prevention and control policy formulation and implementation with asymptomatic HIV infected persons .

###24761893
OBJECTIVE	Molecular pathology tests are often carried for clinicopathological diagnosis and pathologists have established large collections of formalin-fixed , paraffin-embedded tissue ( FFPE ) banks .
OBJECTIVE	However , extraction of DNA from FFPE is a laborious and challenging for researchers in clinical laboratories .
OBJECTIVE	The aim of this study was to compare two widely used DNA extraction methods : using a QIAamp DNA FFPE kit from Qiagen and a Cobas Sample Preparation Kit from Roche , and evaluated the effect of the DNA quality on molecular diagnostics .
METHODS	DNA from FFPE non-small cell lung carcinoma tissues including biopsy and surgical specimens was extracted with both QIAamp DNA FFPE and Cobas Sample Preparation Kits and EGFR mutations of non-small cell lung carcinomas were detected by real-time quantitative PCR using the extracted DNA .
CONCLUSIONS	Our results showed that DNA extracted by QIAamp and Cobas methods were both suitable to detect downstream EGFR mutation in surgical specimens .
CONCLUSIONS	Howover , Cobas method could yield more DNA from biopsy specimens , and gain much better EGFR mutation results .

###25088739
OBJECTIVE	Proximal attachment site complications continue to occur after endovascular repair of abdominal aortic aneurysms ( EVAR ) , specifically type Ia endoleak and endograft migration .
OBJECTIVE	EndoAnchors ( Aptus Endosystems , Sunnyvale , Calif ) were designed to enhance endograft proximal fixation and sealing , and the current study was undertaken to evaluate the potential benefit of this treatment .
METHODS	During the 23-month period ending in December 2013 , 319 subjects were enrolled at 43 sites in the United States and Europe .
METHODS	EndoAnchors were implanted in 242 patients ( 75.9 % ) at the time of an initial EVAR procedure ( primary arm ) and in 77 patients with an existing endograft and proximal aortic neck complications ( revision arm ) .
METHODS	Technical success was defined as deployment of the desired number of EndoAnchors , adequate penetration of the vessel wall , and absence of EndoAnchor fracture .
METHODS	Procedural success was defined as technical success without a type Ia endoleak at completion angiography .
METHODS	Values are expressed as mean standard deviation and interquartile range .
RESULTS	The 238 male ( 74.6 % ) and 81 female ( 25.4 % ) subjects had a mean age of 74.1 8.2 years .
RESULTS	Aneurysms averaged 58 13 ( 51-63 ) mm in diameter at the time of EndoAnchor implantation ( core laboratory measurements ) .
RESULTS	The proximal aortic neck averaged 16 13 ( 7-23 ) mm in length ( 42.7 % < 10mm and 42.7 % conical ) and 27 4mm ( 25-30mm ) in diameter ; infrarenal neck angulation was 24 15 ( 13-34 ) degrees .
RESULTS	The number of EndoAnchors deployed was 5.8 2.1 ( 4-7 ) .
RESULTS	Technical success was achieved in 303 patients ( 95.0 % ) and procedural success in 279 patients ( 87.5 % ) , 217 of 240 ( 89.7 % ) and 62 of 77 ( 80.5 % ) in the primary and revision arms , respectively .
RESULTS	There were 29 residual type Ia endoleaks ( 9.1 % ) at the end of the procedure .
RESULTS	During mean follow-up of 9.3 4.7 months , 301 patients ( 94.4 % ) were free from secondary procedures .
RESULTS	Among the 18 secondary procedures , eight were performed for residual type Ia endoleaks and the others were unrelated to EndoAnchors .
RESULTS	There were no open surgical conversions , there were no aneurysm-related deaths , and no aneurysm ruptured during follow-up .
CONCLUSIONS	Use of EndoAnchors to treat existing and acute type Ia endoleaks and endograft migration was successful in most cases .
CONCLUSIONS	Prophylactic use of EndoAnchors in patients with hostile aortic neck anatomy appears promising , but definitive conclusions must await longer term follow-up data .

###25833777
BACKGROUND	Meals with a low glycemic index ( GI ) and rich in fiber could be beneficial with regard to postprandial metabolic profile and satiety .
OBJECTIVE	The aim of this study was to investigate the effect of 4 breakfasts with a different GI and amount of fiber on postprandial plasma glucose , insulin , and appetite in patients with type 2 diabetes .
METHODS	This randomized 4-intervention crossover trial included 14 patients [ 7 men ; ages 65.8 5.2 y ; glycated hemoglobin : 6.6 0.9 % ; BMI ( in kg/m ( 2 ) ) : 27.2 3.1 ] .
METHODS	Dietary interventions were as follows : breakfasts with a high GI ( 60.4 0.1 % ) and high fiber ( 6.0 0.3 g ) ( HGI-HF ) , a high GI ( 60.9 1.7 % ) and low fiber ( 2.5 0.4 g ) ( HGI-LF ) , a low GI ( 37.7 0.1 % ) and high fiber ( 6.2 0.3 g ) ( LGI-HF ) , and a low GI ( 39.8 1.3 % ) and low fiber ( 2.0 0.1 g ) ( LGI-LF ) .
METHODS	Plasma glucose , insulin , and total ghrelin were evaluated postprandially ( 0-180 min ) .
METHODS	A visual analog scale was used to assess appetite .
METHODS	Data were analyzed by generalized estimating equations and post hoc least significant difference ( LSD ) tests .
METHODS	Data are reported as means SDs .
RESULTS	The area under the curve ( AUC ) [ mean ( 95 % CI ) ; P for LSD tests ] for plasma glucose ( mmol/L min ) was higher after patients consumed the HGI-LF breakfast [ 9.62 ( 8.39 , 10.84 ) ] than after the LGI-HF breakfast [ 8.95 ( 7.71 , 10.18 ) ] ( P 0.05 ) .
RESULTS	Insulin AUC ( IU/mL min ) after patients consumed the HGI-LF meal [ 65.72 ( 38.24 , 93.19 ) ] was higher than after the HGI-HF meal [ 57.24 ( 32.44 , 82.04 ) ] ( P 0.05 ) .
RESULTS	The other observed difference was higher insulin AUC after the consumption of the LGI-LF breakfast [ 61.54 ( 36.61 , 86.48 ) ] compared with the AUC after the LGI-HF breakfast [ 54.16 ( 31.43 , 76.88 ) ] ( P 0.05 ) .
RESULTS	Plasma ghrelin decreased in comparison with baseline only after patients consumed the LGI-HF and LGI-LF breakfasts ( P 0.05 ) .
RESULTS	Subjective satiety did not differ between breakfasts .
CONCLUSIONS	Plasma glucose , insulin , and ghrelin responses were least favorable when patients with type 2 diabetes consumed a breakfast with a high GI and low fiber , which suggests that reducing the GI or increasing the fiber content or both of breakfasts may be a useful strategy to improve the postprandial metabolic profile of these patients .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01410292 .

###24738463
OBJECTIVE	To investigate the feasibility and effect of early removal of the urethral catheter after transurethral plasma kinetic resection of the prostate ( PKRP ) in the treatment of benign prostatic hyperplasia ( BPH ) .
METHODS	We equally randomized 128 BPH patients treated by PKRP to an experimental group and a control group , urethral catheters removed at 1 -2 days for the former and at 5 -7 days for the latter .
METHODS	We compared the relevant indexes and clinical effects between the two groups .
RESULTS	The baseline data were not significantly different between the two groups .
RESULTS	Compared with the controls , the experimental group showed a significantly shorter postoperative hospital stay ( [ 6.8 + / - 1.9 ] d vs [ 3.7 + / - 1.5 ] d , P < 0.05 ) and lower infection rate ( 25.0 % vs 10.9 % , P < 0.05 ) .
RESULTS	All the patients were followed up for 3 -6 months postoperatively .
RESULTS	At 3 months after surgery , both the experimental and the control groups showed remarkable improvement in the International Prostatic Symptoms Scores ( 4.9 + / - 2.2 vs 5.3 + / - 2.3 ) , maximum urine flow rate ( [ 21.5 + / - 5.6 ] ml/s vs [ 19.1 + / -4.9 ] ml/s ) , and residual urine ( [ 16.8 + / - 10.3 ] ml vs [ 18.9 + / - 12.3 ] ml ) , but with no significant differences between the two ( P > 0.05 ) , and no significant differences were observed in postoperative complications ( P > 0.05 ) .
CONCLUSIONS	Early removal of the urethral catheter after PKRP , with its advantages of shorter postoperative hospital stay , lower infection rate , and no influence on the long-term effect , deserves to be recommended as a routine method in the treatment of BPH .

###25344466
BACKGROUND	No previous studies have validated the use of portable monitoring ( PM ) for the diagnosis of obstructive sleep apnea ( OSA ) in morbidly obese individuals .
BACKGROUND	Our aim was to investigate the accuracy of PM for detecting respiratory events in morbidly obese patients that will be undergoing bariatric surgery .
METHODS	This was a prospective study involving patients with body mass index ( BMI ) 35 kg/m ( 2 ) who were recruited from the Sleep Clinic of Universidade Federal de So Paulo .
METHODS	Sleep-disordered breathing ( SDB ) was evaluated during full-night polysomnography ( PSG ) .
METHODS	PM use was randomized and used on two consecutive nights : ( 1 ) at home ( STDHome ) and ( 2 ) at the sleep laboratory with PSG ( PSG_STDLab ) .
RESULTS	Although 58 participants initially underwent the recordings , 26 ( 45 % ) were excluded because of technical problems .
RESULTS	The patients ' mean age was 42.910.9 ( SD ) years , and 56 % were female .
RESULTS	The mean BMI was 40.85.2 kg/m ( 2 ) .
RESULTS	All patients had high risk for OSA , as defined by the Stop-Bang questionnaire , and the mean apnea-hypopnea index ( AHI ) was 46.930.4 / h.
RESULTS	The intraclass coefficient of the correlation between AHI_PSG and AHI_STDLab was r = 0.92 ( p = 0.0001 ) ; the intraclass coefficient for AHI_PSG and AHI_STDHome was r = 0.84 ( p = 0.0001 ) .
RESULTS	The Kappa index was 0.87 ( p > 0.0001 ) for severe cases .
RESULTS	The sensitivity and the positive predictive value increased with the disease severity .
RESULTS	A Bland-Altman analysis showed good agreement between the investigated methods .
CONCLUSIONS	PM is an efficacious method for diagnosing OSA in obese patients who have a high clinical probability of the disease .
CONCLUSIONS	The method displays good sensitivity and specificity in severe cases ; nevertheless , the high rate of data loss must be taken into account .

###25332483
BACKGROUND	There is evidence to support the use of lipid-based nutrient supplements ( LNSs ) to promote child growth and development in low-income countries , but there is also a concern regarding the safety of using iron-fortified products in malaria-endemic areas .
OBJECTIVE	The objective of this study was to test the hypothesis that 6 - to 18-mo-old rural Malawian children receiving iron-containing ( 6 mg/d ) LNSs would not have excess morbidity compared with infants receiving no supplementation .
METHODS	A randomized controlled trial allocated 840 children to receive daily supplementation with 54 g/d LNS with milk protein base ( milk-LNS ) , 54 g/d LNS with soy protein base ( soy-LNS ) , 71 g/d corn-soy blend ( CSB ) , or no supplementation from 6 to 18 mo of age .
METHODS	Morbidity was compared using a non-inferiority margin set at 20 % excess morbidity in supplemented groups compared with the nonsupplemented group .
RESULTS	Baseline characteristics were similar across groups .
RESULTS	The proportion of days with febrile illness between 6 and 18 mo was 4.9 % , and there were no differences between the groups : 4.9 % ( 95 % CI : 4.3 , 5.5 % ) , 4.5 % ( 95 % CI : 3.9 , 5.1 % ) , 4.7 % ( 95 % CI : 4.1 , 5.3 % ) , and 5.5 % ( 95 % CI : 4.7-6 .3 % ) in the milk-LNS , soy-LNS , CSB , and control groups , respectively .
RESULTS	The proportion of days with respiratory problems and diarrhea between 6 and 18 mo also did not differ between groups .
RESULTS	Compared with controls , the incident rate ratio ( 95 % CI ) for clinical malaria was 0.80 ( 0.59 , 1.09 ) , 0.77 ( 0.56 , 1.06 ) , and 0.79 ( 0.58 , 1.08 ) in milk-LNS , soy-LNS , and CSB , respectively , with 95 % CIs confirming non-inferiority .
RESULTS	The incidence of febrile episodes , diarrhea , respiratory problems or admission to hospital , prevalence of malaria parasitemia throughout the follow-up , and mean change in hemoglobin concentration from baseline were also similar between the groups .
CONCLUSIONS	Daily supplementation with 54 g of milk-based or soy protein-based LNS or 71 g of CSB did not result in increases in malaria or respiratory morbidity in children in a malaria-endemic setting .
CONCLUSIONS	However , we could not conclude whether LNSs did or did not increase diarrheal morbidity .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT00524446 .

###24953276
BACKGROUND	To investigate the rate of operative success in excision of nonpalpable lymph nodes with metastatic disease achieved with radioguided occult lesion localization ( ROLL ) and intraoperative ultrasonography ( IOUS ) in patients with papillary thyroid cancer ( PTC ) .
METHODS	Twenty consecutive PTC patients with nonpalpable lymph nodes with metastatic disease localized in previously operated fields were randomized to receive ROLL ( n = 11 ) or IOUS ( n = 9 ) .
METHODS	Nodes were excised along with adjacent soft tissue to accomplish a compartment-oriented dissection .
METHODS	The duration of operation , rate of postoperative complications , pre - and postoperative serum thyroglobulin ( Tg ) levels , and the findings of postoperative neck ultrasonography and postablation scan were recorded in all patients .
METHODS	Measures of operative success included a postoperative Tg level < 50 % of preoperative Tg level and no abnormal lesions on postoperative imaging .
RESULTS	Histopathologic examination confirmed the excision of all preoperatively identified metastatic nodes .
RESULTS	Additional nodes also were excised ( 2.3 3.3 per specimen in the ROLL group and 1.6 1.8 per specimen in the IOUS group ) , 23 % of which were metastatic .
RESULTS	No postoperative complications occurred in either group .
RESULTS	The duration of operation was similar in the 2 groups ( P = .4 ) .
RESULTS	Postoperative imaging confirmed the clearance of suspicious nodes in all patients .
RESULTS	The rate of operative success in ROLL and IOUS group were 100 % and 89 % , respectively .
CONCLUSIONS	In patients with recurrent PTC , a high rate of operative success in excision of nonpalpable metastatic lymph nodes was achieved by both ROLL and IOUS .
CONCLUSIONS	We recommend compartment-oriented dissection ; this approach may maximize the removal of metastatic nodes not identified by preoperative imaging .

###24718736
OBJECTIVE	Extensive blood loss after total knee arthroplasty ( TKA ) may be a potential problem since it leads to anaemia , increased need for transfusion and prolonged hospitalization .
OBJECTIVE	Aim of this study was to investigate the effects of postoperative knee flexion after TKA on blood loss and the need for transfusion .
METHODS	One hundred consecutive patients undergoing primary TKA from 2012 to 2013 were randomizely divided into two groups .
METHODS	In one group , the knee was extended for the first 6 h after surgery , whereas in the other was flexed at 90 for the same time .
METHODS	Two doses of endovenous tranexamic acid were administered in all subjects .
METHODS	Patients were homogeneous for all the possible confounding factors .
RESULTS	Calculated blood loss was 846 197 ( ml ) in the flexion group and 1,242 228 ( ml ) in the extension group ( p < 0.05 ) .
RESULTS	Drop of haemoglobin levels at 24 h in the study group and the control group was 1.9 0.8 ( g/dl ) and 3.0 0.5 ( g/dl ) , respectively ( p < 0.01 ) .
RESULTS	Drop of haematocrit at 24 h was 4.5 0.2 ( % ) in the flexion group and 6.7 0.3 ( % ) in the extension group ( p < 0.05 ) .
RESULTS	Blood transfusion was necessary in 5 patients in the control group and was not necessary in any patient of the study group .
RESULTS	Average knee flexion at day 7 was 105 4 in the flexion group and 98 7 in the extension group .
CONCLUSIONS	Knee flexion at 90 after TKA , associated with the intraoperative use of tranexamic , acid is an effective method to reduce blood loss and the need for blood transfusion .
CONCLUSIONS	The routine use of the present protocol is effective in reducing social costs and length of hospitalization of TKA procedures .

###24886683
BACKGROUND	Around 150,000 people each year attend hospitals in England due to self-harm , many of them more than once .
BACKGROUND	Over 5,000 people die by suicide each year in the UK , a quarter of them having attended hospital in the previous year because of self-harm .
BACKGROUND	Self-harm is a major identifiable risk factor for suicide .
BACKGROUND	People receive variable care at hospital ; many are not assessed for their psychological needs and little psychological therapy is offered .
BACKGROUND	Despite its frequent occurrence , we have no clear research evidence about how to reduce the repetition of self-harm .
BACKGROUND	Some people who have self-harmed show less active ways of solving problems , and brief problem-solving therapies are considered the most promising psychological treatments .
METHODS	This is a pragmatic , individually randomised , controlled , feasibility study comparing interpersonal problem-solving therapy plus treatment-as-usual with treatment-as-usual alone , for adults attending a general hospital following self-harm .
METHODS	A total of 60 participants will be randomised equally between the treatment arms , which will be balanced with respect to the type of most recent self-harm event , number of previous self-harm events , gender and age .
METHODS	Feasibility objectives are as follows : a ) To establish and field test procedures for implementing the problem-solving intervention ; b ) To determine the feasibility and best method of participant recruitment and follow up ; c ) To assess therapeutic delivery ; d ) To assess the feasibility of obtaining the definitive trial 's primary and secondary outcomes ; e ) To assess the perceived burden and acceptability of obtaining the trial 's self-reported outcome data ; f ) To inform the sample size calculation for the definitive trial .
CONCLUSIONS	The results of this feasibility study will be used to determine the appropriateness of proceeding to a definitive trial and will allow us to design an achievable trial of interpersonal problem-solving therapy for adults who self-harm .
BACKGROUND	Current Controlled Trials ( ISRCTN54036115 ) .

###24997825
OBJECTIVE	To compare the efficacy and safety between liposome-paclitaxel plus carboplatin ( LPC ) and paclitaxel plus carboplatin ( PC ) as first-line treatment for advanced non-small cell lung cancer ( NSCLC ) .
METHODS	Totally 54 chemotherapy-naive NSCLC patients were equally and randomly assigned into LPC group and PC group .
METHODS	Liposome-paclitaxel was injected on D1 at a dosage of 175 mg/m ( 2 ) ; the same dose and administration with paclitaxel injection in the PC group for a maximum of 2 cycles .
METHODS	The efficacy and adverse reactions after 2 cycles of chemotherapy were compared between these two groups .
RESULTS	The overall response rate ( CR+PR ) was 44.4 % in the LPC group and 33.3 % in the PC group after 2 cycles of chemotherapy respectively ( P = 0.577 ) .
RESULTS	In the LPC group and PC group , the incidences of myelodepression was 81.5 % and 63.0 % , respectively ( P = 0.080 ) , gastrointestinal toxicity was 96.3 % and 77.8 % respectively ( P = 0.100 ) , and allergic reactions was 0 and 11.1 % , respectively ( P = 0.000 ) .
RESULTS	The median time to progression was 6 months and 5 months , respectively ( P = 0.420 ) .
CONCLUSIONS	LPC group has the same efficacy with PC group and less adverse reactions than PC group .

###24951609
BACKGROUND	The Trastuzumab for Gastric Cancer phase III trial demonstrated that combining trastuzumab with chemotherapy significantly improved overall survival compared with chemotherapy alone in HER2-positive advanced gastric or gastroesophageal junction cancer .
BACKGROUND	We report health-related quality of life ( HRQoL ) and quality-adjusted time without symptoms of disease or toxicity ( Q-TWiST ) results from this trial .
METHODS	Patients were randomized to receive six cycles of chemotherapy given every 3 weeks ( capecitabine or fluorouracil , plus cisplatin ) either alone or combined with administration of trastuzumab every 3 weeks until disease progression .
METHODS	At each clinical visit , HRQoL was assessed using two European Organization for Research and Treatment of Cancer quality of life questionnaires , QLQ-C30 and QLQ-STO22 .
METHODS	Q-TWiST methodology was applied retrospectively using the clinical data and utility coefficients .
RESULTS	Trastuzumab plus chemotherapy prolonged time to 10 % definitive deterioration in all QLQ-C30 and QLQ-STO22 scores , including QLQ-C30 global health status versus chemotherapy alone , from 6.4 months to 10.2 months .
RESULTS	In addition , trastuzumab plus chemotherapy extended Q-TWiST by 2.42 months compared with chemotherapy alone .
CONCLUSIONS	Compared with chemotherapy alone , trastuzumab plus chemotherapy prolongs time to deterioration of HRQoL and increases quality-adjusted survival in patients with HER2-positive gastric or gastroesophageal junction cancer .

###24474520
BACKGROUND	Verification of proper placement of an intravenous catheter may not always be simple .
BACKGROUND	We evaluated the auscultation technique for this purpose .
METHODS	Twenty healthy volunteers were randomized for 18G catheter inserted intravenously either in the right ( 12 ) or left arm ( 8 ) , and subcutaneously in the opposite arm .
METHODS	A standard stethoscope was placed over an area approximately 3 cm proximal to the tip of the catheter in the presumed direction of the vein to grade on a 0-6 scale the murmur heard by rapidly injecting 2 mL of NaCl 0.9 % solution .
METHODS	The auscultation was evaluated by a blinded staff anesthesiologist .
RESULTS	All 20 intravenous injection were evaluated as flow murmurs , and were graded an average 5.65 ( 0.98 ) , whereas all 20 subcutaneous injections were evaluated as either crackles or no sound , and were graded an average 2.00 ( 1.38 ) , without negative results .
RESULTS	Sensitivity was calculated as 95 % .
RESULTS	Specificity and Kappa could not be calculated due to an empty false-positive group .
CONCLUSIONS	Being simple , handy and noninvasive , we recommend to use the auscultation technique for verification of the proper placement of an intravenous catheter when uncertain of its position .
CONCLUSIONS	Data obtained in our limited sample of healthy subjects need to be confirmed in the clinical setting .

###25653009
BACKGROUND	Tai Chi is the Chinese traditional medicine exercise for mind-body health .
BACKGROUND	The objective of this study is to investigate the effect of Tai Chi Chuan ( TCC ) exercise on the proliferative and cytolytic/tumoricidal activities of peripheral blood mononuclear cells ( PBMCs ) in postsurgical non-small cell lung cancer ( NSCLC ) patients .
METHODS	Patients ( n = 27 ) were randomly divided into the control group ( n = 13 ) and the TCC group ( n = 14 ) .
METHODS	TCC group participated in Tai Chi 24-type exercise for 16weeks , 60-min every time , and three times a week .
METHODS	Peripheral blood was collected and PBMCs isolated before and after the 16-week TCC , PBMC proliferation and co-culture of PBMCs with the NSCLC cell line A549 were performed for proliferation and cell cytolysis assays .
METHODS	Analysis of NKT cells , NK cells , and CD123 + and CD11c + dendritic cells were also performed .
RESULTS	( 1 ) After 16-week of TCC , cell proliferation increased significantly as compared with the control .
RESULTS	( 2 ) PBMCs from the TCC group also demonstrated enhanced cytolytic/oncolytic activity against A549 cells .
RESULTS	( 3 ) Significant differences were also found in NK cell percentage at t = 16weeks , post-pre changes of NKT and DC11c between groups .
CONCLUSIONS	Regular Tai Chi exercise has the promise of enhancing PBMC proliferative and cytolytic activities in NSCLC patients .
CONCLUSIONS	Our results affirm the value of a future trial with a larger scale and longer duration for cancer survivors .
BACKGROUND	ChiCTR-TRC-11001404 .

###25574674
BACKGROUND	Perimenopausal women can experience rapid bone loss at skeletal sites with both cortical and cancellous bone , increasing the prevalence of osteoporosis following menopause .
METHODS	We conducted a 12-month randomized placebo-controlled trial evaluating the effects of alendronate 70 mg with 2800 IU cholecalciferol administered once per week for 12 months in comparison with placebo and cholecalciferol .
METHODS	The primary end-point was the percentage change in the lumbar spine bone mineral density ( BMD ) from baseline to 12 months .
METHODS	Secondary end-points were the change in BMD at the femoral neck and changes in biochemical markers of bone turnover .
RESULTS	Forty-five women were recruited to participate in the study .
RESULTS	Five subjects withdrew from the study before randomization for unrelated reasons .
RESULTS	Forty subjects were randomly allocated to the alendronate and placebo groups .
RESULTS	The mean lumbar spine MD in women treated with alendronate increased by 3.66 % ( mean paired difference , d = 0.032 ; 0.008 SE ) at 12 months , compared with a reduction of 3.33 % ( d = -0.030 ; 0.008 SE ) in the control group ( P < 0.001 ) .
RESULTS	In the femoral neck , the mean BMD in the alendronate group increased by 2.07 % ( d = 0.014 ; 0.009 SE ) at 12 months , compared with a reduction of 1.87 % ( d = -0.014 ; 0.008 SE ) in the control group ( P = 0.046 ) .
RESULTS	There were no differences in BMD between the alendronate and placebo groups at the total hip sites after 12 months .
RESULTS	At 12 months , both bone-specific alkaline phosphatase and urinary N-telopeptide were significantly reduced , by 37.79 % ( d = -9.90 ; 1.92 SE ) and 27.21 % ( d = -11.68 ; 4.80 SE ) respectively , in the alendronate group ; in the control group , these levels increased ( P < 0.001 ) .
CONCLUSIONS	Weekly treatment with alendronate 70 mg and cholecalciferol 2800 IU increases BMD and decreases bone turnover in perimenopausal women .

###24354904
OBJECTIVE	To evaluate the effect of body position on the cardiorespiratory indicators of preterm newborns receiving nasal continuous positive airway pressure ( CPAP ) .
METHODS	Analytical , observational , prospective , cross-sectional , randomised crossover study was carried out on sixteen newborns that received nasal CPAP .
METHODS	The infants had a mean gestational age of 29.7 2 weeks and birthweight of 1353 280 g. Cardiorespiratory indicators ( respiratory rate , heart rate and oxygen saturation ) were evaluated in each infant in the supine , prone and right and left lateral decubitus positions at intervals of 10 min over a period of 60 min .
RESULTS	The cardiorespiratory indicators were similar and within the normal range in the four decubitus positions .
RESULTS	There was no difference in respiratory or heart rate between body positions .
RESULTS	Although they showed desirable values , oxygen saturation was significantly lower in left lateral decubitus ( 96.6 1.7 % ) when compared to the supine ( 97.1 1.3 % ) and prone positions ( 97.4 1.1 % ) ( p = 0.00 ) and was also significantly lower in right lateral decubitus ( 96.9 1.4 % ) when compared to the prone position ( p = 0.00 ) .
CONCLUSIONS	We found no preferential decubitus position for preterm newborns receiving nasal CPAP , the supine position may be a choice , but the left and right lateral positions were less advantageous in terms of oxygen saturation .

###24742032
BACKGROUND	General practitioners with more positive role security and therapeutic commitment towards patients with hazardous or harmful alcohol consumption are more involved and manage more alcohol-related problems than others .
BACKGROUND	In this study we evaluated the effects of our tailored multi-faceted improvement implementation programme on GPs ' role security and therapeutic commitment and , in addition , which professional related factors influenced the impact of the implementation programme .
METHODS	In a cluster randomised controlled trial , 124 GPs from 82 Dutch general practices were randomised to either the intervention or control group .
METHODS	The tailored , multi-faceted programme included combined physician , organisation , and patient directed alcohol-specific implementation strategies to increase role security and therapeutic commitment in GPs .
METHODS	The control group was mailed the national guideline and patients received feedback letters .
METHODS	Questionnaires were completed before and 12 months after start of the programme .
METHODS	We performed linear multilevel regression analysis to evaluate effects of the implementation programme .
RESULTS	Participating GPs were predominantly male ( 63 % ) and had received very low levels of alcohol related education before start of the study ( 0.4 h ) .
RESULTS	The programme increased therapeutic commitment ( p = 0.005 ; 95 % - CI 0.13 - 0.73 ) but not role security ( p = 0.58 ; 95 % - CI -0.31 - 0.54 ) .
RESULTS	How important GPs thought it was to improve their care for problematic alcohol consumption , and the GPs ' reported proportion of patients asked about alcohol consumption at baseline , contributed to the effect of the programme on therapeutic commitment .
CONCLUSIONS	A tailored , multi-faceted programme aimed at improving GP management of patients with hazardous and harmful alcohol consumption improved GPs ' therapeutic commitment towards patients with alcohol-related problems , but failed to improve GPs ' role security .
CONCLUSIONS	How important GPs thought it was to improve their care for problematic alcohol consumption , and the GPs ' reported proportion of patients asked about alcohol consumption at baseline , both increased the impact of the programme on therapeutic commitment .
CONCLUSIONS	It might be worthwhile to monitor proceeding of role security and therapeutic commitment throughout the year after the implementation programme , to see whether the programme is effective on short term but faded out on the longer term .
BACKGROUND	ClinicalTrials.gov Identifier : NCT00298220 .

###24398732
BACKGROUND	Standardized training via simulation as an educational adjunct may lead to a more rapid and complete skill achievement .
BACKGROUND	The authors hypothesized that simulation training will also enhance performance in transesophageal echocardiography image acquisition among anesthesia residents .
METHODS	A total of 42 clinical anesthesia residents were randomized to one of two groups : a control group , which received traditional didactic training , and a simulator group , whose training used a transesophageal echocardiography-mannequin simulator .
METHODS	Each participating resident was directed to obtain 10 commonly used standard views on an anesthetized patient under attending supervision .
METHODS	Each of the 10 selected echocardiographic views were evaluated on a grading scale of 0 to 10 , according to predetermined criteria .
METHODS	The effect of the intervention was assessed by using a linear mixed model implemented in SAS 9.3 ( SAS Institute Inc. , Cary , NC ) .
RESULTS	Residents in the simulation group obtained significantly higher-quality images with a mean total image quality score of 83 ( 95 % CI , 74 to 92 ) versus the control group score of 67 ( 95 % CI , 58 to 76 ) ; P = 0.016 .
RESULTS	On average , 71 % ( 95 % CI , 58 to 85 ) of images acquired by each resident in the simulator group were acceptable for clinical use compared with 48 % ( 95 % CI , 35 to 62 ) in the control ; P = 0.021 .
RESULTS	Additionally , the mean difference in score between training groups was the greatest for the clinical anesthesia-1 residents ( difference 24 ; P = 0.031 ; n = 7 per group ) and for those with no previous transesophageal echocardiography experience ( difference 26 ; P = 0.005 ; simulator n = 13 ; control n = 11 ) .
CONCLUSIONS	Simulation-based transesophageal echocardiography education enhances image acquisition skills in anesthesiology residents .

###25450847
OBJECTIVE	To describe associations between total and regional body fat mass loss and reduction of systemic levels of inflammation ( C-reactive protein ( CRP ) and interleukin-6 ( IL-6 ) ) in obese , older adults with osteoarthritis ( OA ) , undergoing intentional weight loss .
METHODS	Data come from a single-blind , 18-month , randomized controlled trial in adults ( age : 65.6 6.2 ; Body mass index ( BMI ) : 33.6 3.7 ) with knee OA .
METHODS	Participants were randomized to diet-induced weight loss plus exercise ( D + E ; n = 150 ) , diet-induced weight loss-only ( D ; n = 149 ) , or exercise-only ( E ; n = 151 ) .
METHODS	Total body and region-specific ( abdomen and thigh ) fat mass were measured at baseline and 18 months .
METHODS	High-sensitivity CRP and IL-6 were measured at baseline , six and 18 months .
METHODS	Intervention effects were assessed using mixed models and associations between inflammation and adiposity were compared using logistic and mixed linear regression models .
RESULTS	Intentional total body fat mass reduction was associated with significant reductions in log-adjusted CRP ( = 0.06 ( 95 % CI = 0.04 , 0.08 ) mg/L ) and IL-6 ( = 0.02 ( 95 % CI = 0.01 , 0.04 ) pg/mL ) .
RESULTS	Loss of abdominal fat volume was also associated with reduced inflammation , independent of total body fat mass ; although models containing measures of total adiposity yielded the best fit .
RESULTS	The odds of achieving clinically desirable levels of CRP ( < 3.0 mg/L ) and IL-6 ( < 2.5 pg/mL ) were 3.8 ( 95 % CI = 1.6 , 8.9 ) and 2.2 ( 95 % CI = 1.1 , 4.6 ) , respectively , with 5 % total weight and fat mass loss .
CONCLUSIONS	Achievement of clinically desirable levels of CRP and IL-6 more than double with intentional 5 % loss of total body weight and fat mass .
CONCLUSIONS	Global , rather than regional , measures of adiposity are better predictors of change in inflammatory burden .
BACKGROUND	NCT00381290 .

###24604461
OBJECTIVE	To explore the effect of cognitive behavioral therapy ( CBT ) in combination with systemic family therapy ( SFT ) on mild to moderate postpartum depression and sleep quality .
METHODS	249 primiparous women with mild to moderate postpartum depression were recruited and randomly assigned to a control group ( n = 128 ) , which received conventional postpartum care , or to a psychological intervention group ( n = 121 ) , which received conventional postpartum care combined with psychological intervention .
METHODS	The Edinburgh Postnatal Depression Scale ( EPDS ) and Pittsburgh Sleep Quality Index ( PSQI ) were employed to evaluate depression and sleep quality , respectively .
RESULTS	104 patients in the intervention group and 109 in the control group completed the study .
RESULTS	After intervention , the EPDS score , PSQI score , sleep quality score , sleep latency score , sleep duration score , habitual sleep efficiency score , sleep disturbance score , and daytime dysfunction score were significantly lower in the intervention group than in the control group .
RESULTS	The EPDS and PSQI scores of each group at different time points after intervention were markedly decreased compared with those before intervention , and the reduction in the intervention group was more evident than that in the control group .
CONCLUSIONS	CBT in combination with SFT can improve depression and sleep quality in patients with mild to moderate postpartum depression .

###25489844
BACKGROUND	Cytomegalovirus ( CMV ) and Epstein-Barr virus ( EBV ) infections are a significant cause of morbidity and mortality in transplant recipients and are often transmitted from the donor organ .
METHODS	In a pilot prospective , randomized , double-blinded , placebo-controlled trial , we studied whether 14 days of pretransplant donor treatment with valganciclovir ( valG ) versus placebo reduced donor-to-recipient transmission , making posttransplant recipient prophylaxis more effective in reducing EBV and CMV disease .
RESULTS	Seventeen D + R - donor-recipient pairs were enrolled : 7 and 10 donors were randomized to valG and placebo , respectively .
RESULTS	At study initiation , no donor had detectable CMV replication , five had EBV replication ( two in valG , three in placebo group ) : EBV replication was undetectable during valG treatment , but resumed on stopping valG .
RESULTS	Valganciclovir was tolerated without side effects or leukopenia .
RESULTS	All recipients received routine posttransplant viral prophylaxis with valG .
RESULTS	For recipients , viremia-free survival time , incidence , range , peak , and duration of CMV and EBV viremia were not significantly different between groups .
RESULTS	There was no disease in the valG group but two serious viral diseases occurred in the placebo group ( one CMV ; one EBV-related posttransplant lymphoproliferative disorder ) .
RESULTS	In the case of posttransplant lymphoproliferative disorder , the EBV DNA from the donor 's oral wash and the recipient 's lymphoid tissue biopsy had identical latent membrane protein 1 ( LMP-1 ) sequence variations from the reference EBV strain , making it highly probable that the recipient 's virus was of donor origin .
CONCLUSIONS	Based on this pilot trial , we recommend an adequately powered study to determine if pretransplant donor treatment with valG can reduce posttransplant CMV and EBV disease with merely routine posttransplant recipient viral prophylaxis .

###25143717
OBJECTIVE	To study the efficacy of traditional Thai massage ( TTM ) versus conventional physical therapy ( PT ) programs in treating muscle spasticity , functional ability , anxiety , depression , and quality of life ( QoL ) in Thai stroke patients .
METHODS	This randomized controlled trial with a blinded assessor was carried out at the Department of Rehabilitation Medicine , Siriraj Hospital ( Bangkok , Thailand ) .
METHODS	The study included 50 stroke ( onset 3 months ) outpatients experiencing spasticity at the elbow or knee muscles at a grade of 1 + on the modified Ashworth Scale who were 50 years old and able to communicate .
METHODS	The subjects were randomly allocated to the treatment group receiving TTM ( 24 subjects ) or the control group receiving the PT program ( 26 subjects ) .
METHODS	Both groups received treatment ( either TTM or PT ) twice a week for 6 weeks .
METHODS	Spasticity grade , functional ability , anxiety , depression , and QoL were measured at Week 0 and Week 6 .
RESULTS	At Week 6 , the percentage of patients whose modified Ashworth Scale score had decreased by at least one grade was not statistically significant between the two groups .
RESULTS	Both TTM and PT groups experienced a significant increase in functional ability and QoL , but no difference was found between the groups .
RESULTS	Anxiety and depression scores showed a decreasing trend in the TTM group .
CONCLUSIONS	This preliminary report showed no evidence that TTM differed from the PT program in decreasing spasticity .
CONCLUSIONS	However , both interventions may relieve spasticity , increase functional ability , and improve QoL after 6 weeks .
CONCLUSIONS	Only TTM can decrease anxiety and depression scores .
CONCLUSIONS	Further studies with adequate sample size are necessary .

###25569354
OBJECTIVE	To investigate the effects of an active and a passive recovery protocol on physiological responses and performance between 2 heats in sprint cross-country skiing .
METHODS	Ten elite male skiers ( 223 y , 1844 cm , 797 kg ) undertook 2 experimental test sessions that both consisted of 2 heats with 25 min between start of the first and second heats .
METHODS	The heats were conducted as an 800-m time trial ( 6 , > 3.5 m/s , ~ 205 s ) and included measurements of oxygen uptake ( VO2 ) and accumulated oxygen deficit .
METHODS	The active recovery trial involved 2 min standing/walking , 16 min jogging ( 58 % 5 % of VO2peak ) , and 3 min standing/walking .
METHODS	The passive recovery trial involved 15 min sitting , 3 min walk/jog ( ~ 30 % of VO2peak ) , and 3 min standing/walking .
METHODS	Blood lactate concentration and heart rate were monitored throughout the recovery periods .
RESULTS	The increased 800-m time between heat 1 and heat 2 was trivial after active recovery ( effect size [ ES ] = 0.1 , P = .64 ) and small after passive recovery ( ES = 0.4 , P = .14 ) .
RESULTS	The 1.2 % 2.1 % ( mean90 % CL ) difference between protocols was not significant ( ES = 0.3 , P = .3 ) .
RESULTS	In heat 2 , peak and average VO2 was increased after the active recovery protocol .
CONCLUSIONS	Neither passive recovery nor running at ~ 58 % of VO2peak between 2 heats changed performance significantly .

###24657491
OBJECTIVE	To examine the role of acupuncture in the treatment of diabetic painful neuropathy ( DPN ) using a single-blind , placebo-controlled RCT and to collect data that would be required in a future definitive study of the efficacy of acupuncture in DPN .
METHODS	45 patients were allocated to receive a 10-week course either of real ( 53 % ) or sham ( 47 % ) acupuncture .
METHODS	Five standardised acupuncture points on the lower limb of each leg were used in the study : LR3 , KI3 , SP6 , SP10 and ST36 .
METHODS	Outcome measures included the Leeds Assessment of Neuropathic Symptoms and Signs ( LANSS ) scale , lower limb pain ( Visual Analogue Scale , VAS ) ; Sleep Problem Scale ( SPS ) ; Measure Yourself Medical Outcome Profile ( MYMOP ) ; 36-item Short Form 36 Health Survey and resting blood pressure ( BP ) .
RESULTS	Over the 10-week treatment period , small improvements were seen in VAS -15 ( -26 to -3.5 ) , MYMOP -0.89 ( -1.4 to -0.3 ) , SPS -2.5 ( -4.2 to -0.82 ) and resting diastolic BP -5.2 ( -10.4 to -0.14 ) in the true acupuncture group .
RESULTS	In contrast , there was little change in those receiving sham acupuncture .
RESULTS	A moderate treatment effect in favour of active acupuncture was detected in MYMOP scores -0.66 ( -0.96 to -0.35 ) but non-significant effect sizes in LANSS Pain Scale -0.37 ( -2.2 to 1.4 ) , resting diastolic BP -0.50 ( -3.0 to 1.99 ) and the SPS -0.51 ( -2.2 to 1.16 ) .
CONCLUSIONS	We have demonstrated the practicality and feasibility of acupuncture as an additional treatment for people with DPN .
CONCLUSIONS	The treatment was well tolerated with no appreciable side effects .
CONCLUSIONS	Larger randomised trials are needed to confirm the clinical and cost-effectiveness of acupuncture in the treatment of DPN .
BACKGROUND	ISRCTN number : 39740785 .

###25319932
BACKGROUND	Hyaluronic acid ( HA ) fillers and poly-L-lactic acid ( PLA ) fillers are frequently used to correct facial wrinkles .
OBJECTIVE	To compare the efficacy and safety of a novel injectable poly-L-lactic acid ( PLA ) filler and a well-studied biphasic HA filler for the treatment of moderate to severe nasolabial folds .
METHODS	In this multicentre , randomized , evaluator-blinded , comparative study , subjects were randomized for injections with PLA or HA into both nasolabial folds .
METHODS	Efficacy was determined by calculating the change in Wrinkle Severity Rating Scale ( WSRS ) relative to baseline .
METHODS	Local safety was assessed by reported adverse events .
RESULTS	At week 24 , mean improvement in WSRS from baseline was 2.09 0.68 for the PLA side and 1.54 0.65 for the HA side .
RESULTS	Both injections were well tolerated , and the adverse reactions were mild and transient in most cases .
CONCLUSIONS	PLA provides noninferior efficacy compared with HA 6 months after being used to treat moderate to severe nasolabial folds .

###24297379
OBJECTIVE	To explore , using MRI , the disease-modifying effect of strontium ranelate ( SrRan ) treatment on cartilage volume loss ( CVL ) and bone marrow lesions ( BMLs ) in a subset of patients from a Phase III clinical trial in knee osteoarthritis ( OA ) ( SrRan Efficacy in Knee OsteoarthrItis triAl ( SEKOIA ) ) .
METHODS	Patients with primary symptomatic knee OA were randomised to receive either SrRan 1g/day or 2g/day or placebo ( SEKOIA study ) .
METHODS	A subset of these patients had MRIs at baseline , 12 , 24 and 36months to assess the knee cartilage volume and BMLs .
METHODS	Missing values were imputed and the analyses were adjusted according to Bonferroni .
RESULTS	In this MRI subset , the distribution of patients ( modified intention-to-treat ; n = 330 ) was 113 , 105 and 112 for SrRan 1g/day , 2g/day and placebo , respectively .
RESULTS	The groups were fairly balanced at baseline regarding demographics , clinical symptoms or imaging characteristics .
RESULTS	Treatment with SrRan 2g/day significantly decreased CVL on the plateaus at 12 ( p = 0.002 ) and 36 ( p = 0.003 ) months compared with placebo .
RESULTS	Of note , in the medial femur and plateau , SrRan 1g/day , but not SrRan 2g/day , had more CVL than placebo .
RESULTS	In patients with BML in the medial compartment at baseline , the BML score at 36months was decreased in both treatment groups compared with the placebo group ( SrRan 1g/day , p = 0.002 and SrRan 2g/day p = 0.001 , respectively ) , and CVL significantly decreased with SrRan 2g/day ( p = 0.023 ) in the plateau compared with placebo .
CONCLUSIONS	In knee OA patients , treatment with SrRan 2g/day was found to have beneficial effects on structural changes by significantly reducing CVL in the plateau and BML progression in the medial compartment .

###24508204
OBJECTIVE	Relative adrenal insufficiency ( RAI ) has been reported as a predictor of mortality in septic patient ; however , its effects on mortality and outcomes for critically ill patients remain debatable .
OBJECTIVE	The objective of this study was to assess the effect of RAI on prognostic outcomes in patients after out-of-hospital rapid sequence intubation ( RSI ) and factors associated with the onset of RAI .
METHODS	A prespecified ancillary study of KETASED , a randomized prospective multicenter trial , was conducted .
METHODS	Three hundred ten patients who underwent RSI in an out-of-hospital setting had baseline cortisol and adrenocorticotropic hormone response test measurements within 24 hours of intensive care unit admission and were included .
RESULTS	The mean ( SD ) age was 55 ( 19 ) years , with a mean ( SD ) Sequential Organ Failure Assessment score of 9 ( 4 ) .
RESULTS	Two hundred forty-seven ( 69 % ) patients presented with RAI .
RESULTS	Baseline characteristics were similar between patients with and without RAI , except for the use of etomidate as a sedative agent ( 63 % of patients with RAI vs 21 % , P < .001 ) , and history of chronic kidney disease .
RESULTS	There was no difference in terms of 28-day mortality between the 2 groups ( 21 % vs 19 % , P = .65 ) and in terms of other 28-day prognosis end points .
CONCLUSIONS	In critically ill patients who require RSI , RAI is common and is not associated with worsened outcomes in our cohort .

###24880443
OBJECTIVE	The aim of the present study was to evaluate the effect of Erythrinamu lungu on the control of dental anxiety in patients who had under gone bilateral extraction of asymptomatic , impacted mandibular third molars .
METHODS	In a randomized , double-blind , crossover study , 30 healthy volunteers ( 5 men and 25 women , over 18 years of age ) , received either 500mg of E.mulungu ( MulunguMatusa ) or 500 mg of placebo , p.o. , one hour before surgical procedure .
METHODS	The level ofanxiety was assessed through questionnaire sand physical parameters , such as blood pressure , heart rate andoxygen saturation .
METHODS	Data were analyzed by Chi-square test , ANOVA ( Tukey test ) and Friedman with significance level of 5 % .
RESULTS	A higher preference ( Chi-square , p = 0.0062 ) for E. mulungu was observed for both genders .
RESULTS	Volunteers with higher anxiety levels tended to to prefer E. mulungu .
RESULTS	No statistically significant differences were verified in blood pressure ( one-way ANOVA , p = 0.1259 ) , heart rate ( Friedman , p > 0.05 ) and oxygen saturation ( Friedman , p = 0.7664 ) among periods and types of treatments .
CONCLUSIONS	E. mulungu showed an anxiolytic effect without significant changes in physiological parameters .
CONCLUSIONS	It could be considered as an alternative to control the anxiety in adult patients undergoing mandibular thirdmolars surgery .

###24725763
OBJECTIVE	It is well recognized that low-density lipoprotein cholesterol ( LDL-C ) - lowering therapy is effective for primary and secondary prevention of cerebrovascular/cardiovascular disease .
OBJECTIVE	Ezetimibe , an inhibitor of the Niemann-Pick C1-Like 1 cholesterol transporter , is a relatively new drug for LDL-C-lowering therapy in addition to statins .
OBJECTIVE	However , comparison between an aggressive LDL-C-lowering therapy with a combination of statin and ezetimibe versus a standard LDL-C-lowering therapy with statin alone is still unclear in terms of their effects on stabilization and volume regression of coronary plaque .
OBJECTIVE	The ZIPANGU ( Ezetimibe clinical investigation for the regression of intracoronary plaque evaluated by angioscopy and ultrasound ) study is aimed at comparing these two types of therapy based on indices of plaque characteristics using non-obstructive coronary angioscopy and intravascular ultrasound .
METHODS	The study is a multi-center , prospective , randomized , open-label , blinded-endpoint trial .
METHODS	Through a centralized enrollment method , patients will be allocated to either monotherapy with atorvastatin alone or to combination therapy with atorvastatin ( maximum : 20mg/day ) and ezetimibe ( 10mg/day ) .
METHODS	The target LDL-C level will be < 100mg/dL for the monotherapy group and < 70mg/dL for the combination therapy group .
METHODS	At the baseline and the follow-up period of 9 months , non-obstructive coronary angioscopy and intravascular ultrasound will be performed to compare the changes in plaque color and volume between the two groups .
CONCLUSIONS	The ZIPANGU study will clarify whether combination therapy with statins and ezetimibe is better for stabilizing coronary plaque as secondary prevention than monotherapy by statins alone .
CONCLUSIONS	The study will give new insights into lipid-lowering guidelines in Japan .

###24482066
OBJECTIVE	BK virus reactivation in kidney transplant recipients can lead to progressive allograft injury .
OBJECTIVE	Reduction of immunosuppression remains the cornerstone of treatment for active BK infection .
OBJECTIVE	Fluoroquinolone antibiotics are known to have in vitro antiviral properties , but the evidence for their use in patients with BK viremia is inconclusive .
OBJECTIVE	The objective of the study was to determine the efficacy of levofloxacin in the treatment of BK viremia .
METHODS	Enrollment in this prospective , multicenter , double-blinded , placebo-controlled trial occurred from July 2009 to March 2012 .
METHODS	Thirty-nine kidney transplant recipients with BK viremia were randomly assigned to receive levofloxacin , 500 mg daily , or placebo for 30 days .
METHODS	Immunosuppression in all patients was adjusted on the basis of standard clinical practices at each institution .
METHODS	Plasma BK viral load and serum creatinine were measured monthly for 3 months and at 6 months .
RESULTS	At the 3-month follow-up , the percentage reductions in BK viral load were 70.3 % and 69.1 % in the levofloxacin group and the placebo group , respectively ( P = 0.93 ) .
RESULTS	The percentage reductions in BK viral load were also equivalent at 1 month ( 58 % versus and 67.1 % ; P = 0.47 ) and 6 months ( 82.1 % versus 90.5 % ; P = 0.38 ) .
RESULTS	Linear regression analysis of serum creatinine versus time showed no difference in allograft function between the two study groups during the follow-up period .
CONCLUSIONS	A 30-day course of levofloxacin does not significantly improve BK viral load reduction or allograft function when used in addition to overall reduction of immunosuppression .

###24343281
OBJECTIVE	The aim of the study was to determine whether infliximab use and other potential predictors are associated with decreased prevalence and severity of depression in pediatric patients with Crohn disease ( CD ) .
METHODS	A total of 550 ( n = 550 ) youth ages 9 to 17 years with biopsy-confirmed CD were consecutively recruited as part of a multicenter randomized controlled trial .
METHODS	Out of the 550 , 499 patients met study criteria and were included in the analysis .
METHODS	At recruitment , each subject and a parent completed the Children 's Depression Inventory ( CDI ) .
METHODS	A child or parent CDI score 12 was used to denote clinically significant depressive symptoms ( CSDS ) .
METHODS	Child and parent CDI scores were summed to form total CDI ( CDIT ) .
METHODS	Infliximab use , demographic information , steroid use , laboratory values , and Pediatric Crohn 's Disease Activity Index ( PCDAI ) were collected as the potential predictors of depression .
METHODS	Univariate regression models were constructed to determine the relations among predictors , CSDS , and CDIT .
METHODS	Stepwise multivariate regression models were constructed to predict the relation between infliximab use and depression while controlling for other predictors of depression .
RESULTS	Infliximab use was not associated with a decreased proportion of CSDS and CDIT after adjusting for multiple comparisons .
RESULTS	CSDS and CDIT were positively associated with PCDAI , erythrocyte sedimentation rate , and steroid dose ( P < 0.01 ) and negatively associated with socioeconomic status ( SES ) ( P < 0.001 ) .
RESULTS	In multivariate models , PCDAI and SES were the strongest predictors of depression .
CONCLUSIONS	Disease activity and SES are significant predictors of depression in youth with Crohn disease .

###24438569
OBJECTIVE	To compare curative effect between complete denture with lingualized occlusion and anatomic occlusion on temporomandibular joint disorders ( TMD ) of aged edentulous patients with severe residual alveolar ridge resorption .
METHODS	Seventy aged edentulous patients with severe residual alveolar ridge resorption were recruited in this study and randomly assigned into two groups , thirty-five each .
METHODS	In Group A , patients received complete denture with lingualized occlusion , and in Group B , patients received complete denture with anatomic occlusion .
METHODS	The condition of TMD was examined and recorded by the same TMD specialist at baseline , 3 months and 6 months following denture delivery .
METHODS	The recovery effect of TMD was evaluated according to Fricton Index .
METHODS	Related data were analyzed statistically with t-test and rank sum test .
RESULTS	Three months following denture delivery , the craniomandibular index ( CMI ) decrease value was ( 0.064 0.022 ) in group A , and was significantly higher than that in group B ( 0.043 0.018 ) ( P < 0.01 ) .
RESULTS	Six months following denture delivery , the CMI decrease value was ( 0.084 0.020 ) in group A , and was significantly higher than that in group B ( 0.070 0.021 ) ( P = 0.011 < 0.05 ) .
CONCLUSIONS	Complete denture with lingualized occlusion may be more conducive to the remission of TMD for aged edentulous patients with severe residual alveolar ridge resorption .

###24885585
BACKGROUND	To describe the design of the study aiming to examine intensive targeted cognitive rehabilitation of attention in the acute ( < 4months ) and subacute rehabilitation phases ( 4-12 months ) after acquired brain injury and to evaluate the effects on function , activity and participation ( return to work ) .
METHODS	Within a prospective , randomised , controlled study 120 consecutive patients with stroke or traumatic brain injury were randomised to 20 hours of intensive attention training by Attention Process Training or by standard , activity based training .
METHODS	Progress was evaluated by Statistical Process Control and by pre and post measurement of functional and activity levels .
METHODS	Return to work was also evaluated in the post-acute phase .
METHODS	Primary endpoints were the changes in the attention measure , Paced Auditory Serial Addition Test and changes in work ability .
METHODS	Secondary endpoints included measurement of cognitive functions , activity and work return .
METHODS	There were 3 , 6 and 12-month follow ups focussing on health economics .
CONCLUSIONS	The study will provide information on rehabilitation of attention in the early phases after ABI ; effects on function , activity and return to work .
CONCLUSIONS	Further , the application of Statistical Process Control might enable closer investigation of the cognitive changes after acquired brain injury and demonstrate the usefulness of process measures in rehabilitation .
CONCLUSIONS	The study was registered at ClinicalTrials.gov Protocol .
BACKGROUND	NCT02091453 , registered : 19 March 2014 .

###24641808
BACKGROUND	Non-dependent alcohol and substance use patterns are prevalent among men who have sex with men ( MSM ) , yet few effective interventions to reduce their substance use are available for these men .
BACKGROUND	We evaluated whether an adapted brief counseling intervention aimed at reducing HIV risk behavior was associated with secondary benefits of reducing substance use among episodic substance-using MSM ( SUMSM ) .
METHODS	326 episodic SUMSM were randomized to brief Personalized Cognitive Counseling ( PCC ) intervention with rapid HIV testing or to rapid HIV testing only control .
METHODS	Both arms followed over 6 months .
METHODS	Trends in substance use were examined using GEE Poisson models with robust standard errors by arm .
METHODS	Reductions in frequency of use were examined using ordered logistic regression .
RESULTS	In intent-to-treat analyses , compared to men who received rapid HIV testing only , we found men randomized to PCC with rapid HIV testing were more likely to report abstaining from alcohol consumption ( RR = 0.93 ; 95 % CI = 0.89-0 .97 ) , marijuana use ( RR = 0.84 ; 95 % CI = 0.73-0 .98 ) , and erectile dysfunction drug use ( EDD ; RR = 0.51 ; 95 % CI = 0.33-0 .79 ) over the 6-month follow-up .
RESULTS	PCC was also significantly associated with reductions in frequency of alcohol intoxication ( OR = 0.58 ; 95 % CI = 0.36-0 .90 ) over follow-up .
RESULTS	Furthermore , we found PCC was associated with significant reductions in number of unprotected anal intercourse events while under the influence of methamphetamine ( RR = 0.26 ; 95 % CI = 0.08-0 .84 ) .
CONCLUSIONS	The addition of adapted PCC to rapid HIV testing may have benefits in increasing abstinence from certain classes of substances previously associated with HIV risk , including alcohol and EDD ; and reducing alcohol intoxication frequency and high-risk sexual behaviors concurrent with methamphetamine use .

###24757229
OBJECTIVE	To assess the effect of overnight insulin pump suspension in an automated predictive low glucose suspend system on morning blood glucose and ketone levels in an attempt to determine whether routine measurement of ketone levels is useful when a closed-loop system that suspends insulin delivery overnight is being used .
METHODS	Data from an in-home randomized trial of 45 individuals with type 1 diabetes ( age range 15-45 years ) were analyzed , evaluating an automated predictive low glucose pump suspension system in which blood glucose , blood ketone , and urine ketone levels were measured on 1,954 mornings .
RESULTS	One or more pump suspensions occurred during 744 of the 977 intervention nights ( 76 % ) .
RESULTS	The morning blood ketone level was 0.6 mmol/L after 11 of the 744 nights ( 1.5 % ) during which a pump suspension occurred and 2 of the 233 nights ( 0.9 % ) during which there was no suspension compared with 11 of 977 control nights ( 1.1 % ) .
RESULTS	The morning blood ketone level was 0.6 mmol/L after only 2 of 159 nights ( 1.3 % ) with a pump suspension exceeding 2 h. Morning fasting blood glucose level was not a good predictor of the presence of blood ketones .
CONCLUSIONS	Routine measurement of blood or urine ketones during use of an automated pump suspension system using continuous glucose monitoring , whether threshold based or predictive , is not necessary .
CONCLUSIONS	Recommendations for checking ketone levels should be no different when a patient is using a system with automated insulin suspension than it is for conventional diabetes self-management .

###24360368
BACKGROUND	This randomised double-blind placebo-controlled study evaluated the addition of cediranib , an inhibitor of vascular endothelial growth factor receptors 1-3 , to standard carboplatin/paclitaxel chemotherapy in advanced non-small cell lung cancer .
METHODS	Eligible patients received paclitaxel ( 200mg/m ( 2 ) ) and carboplatin ( area under the concentration time curve 6 ) intravenously every 3 weeks .
METHODS	Daily oral cediranib/placebo 20mg was commenced day 1 of cycle 1 and continued as monotherapy after completion of 4-6 cycles of chemotherapy .
METHODS	The primary end-point of the study was overall survival ( OS ) .
METHODS	The trial would continue to full accrual if an interim analysis ( IA ) for progression-free survival ( PFS ) , performed after 170 events of progression or death in the first 260 randomised patients , revealed a hazard ratio ( HR ) for PFS of 0.70 .
RESULTS	The trial was halted for futility at the IA ( HR for PFS 0.89 , 95 % confidence interval [ CI ] 0.66-1 .20 , p = 0.45 ) .
RESULTS	A final analysis was performed on all 306 enrolled patients .
RESULTS	The addition of cediranib increased response rate ( [ RR ] 52 % versus 34 % , p = 0.001 ) but did not significantly improve PFS ( HR 0.91 , 95 % CI 0.71-1 .18 , p = 0.49 ) or OS ( HR 0.94 , 95 % CI 0.69-1 .30 , p = 0.72 ) .
RESULTS	Cediranib patients had more grade 3 hypertension , diarrhoea and anorexia .
CONCLUSIONS	The addition of cediranib 20mg daily to carboplatin/paclitaxel chemotherapy increased RR and toxicity , but not survival .

###25442225
BACKGROUND	Physical activity interventions designed for Latinas have shown short-term behavior change , but longer-term change and maintenance is rarely measured .
OBJECTIVE	To assess physical activity change at 12 months , following 6-month tapered completion of an RCT of a physical activity intervention for Latinas .
METHODS	Two hundred sixty-six underactive ( < 60 minutes/week physical activity ) Latinas were randomized to an individually tailored , culturally and linguistically adapted physical activity intervention , or a wellness contact control .
METHODS	Participants received the materials through the mail for 6 months , then received booster doses at 8 , 10 , and 12 months .
METHODS	Minutes per week of moderate to vigorous physical activity were measured by the 7-Day Physical Activity Recall interview at baseline and 6 and 12 months .
METHODS	Data were collected at Brown University between 2009 and 2013 , and analyses were conducted in 2013 .
RESULTS	At 12 months , increases in moderate to vigorous physical activity were significantly greater in the intervention than in the wellness group ( mean difference = 52 minutes/week , SE = 9.38 , p < 0.01 ) , with both groups showing slight increases in moderate to vigorous physical activity from 6 to 12 months .
RESULTS	Intervention participants were also more likely to meet national moderate to vigorous physical activity guidelines ( OR = 3.14 , p = 0.01 ) .
CONCLUSIONS	The intervention was more effective than the wellness control at 12 months , and physical activity increases from baseline to 6 months were maintained , suggesting the intervention may lead to sustainable behavior change .
BACKGROUND	This study is registered at Clinicaltrials.gov NCT01583140 .

###24585791
OBJECTIVE	To identify the preoperative characteristics and compare operative variables and postoperative outcomes in adult patients with pectus excavatum undergoing thoracoscopic repair using different bar stabilizers or open surgical repair .
METHODS	31 patients were randomly divided into 3 groups : group A was 9 patients who underwent a modified Ravitch repair , group B was 11 patients who underwent video-assisted thoracoscopic repair using metal stabilizers , and group C was 11 patients who underwent video-assisted thoracoscopic repair using absorbable stabilizers .
METHODS	Preoperative , intraoperative , and postoperative variables and mortality were compared among groups .
RESULTS	In all groups , preoperative variables were well-matched for age , sex , and Haller index .
RESULTS	Operative time was significantly longer in group A.
RESULTS	The postoperative length of hospital stay was significantly shorter in group A. Postoperative complications occurred in 7 ( 22.6 % ) patients , mostly in groups B and C. All patients were satisfied with the cosmetic result .
CONCLUSIONS	Repair of pectus excavatum in adult patients can be performed effectively either through an open surgical technique or thoracoscopy , with no intraoperative complications and excellent immediate results , but video-assisted thoracoscopic repair using metallic or absorbable bar stabilizers gives a better cosmetic result ; however , absorbable bar stabilizers are more vulnerable and break more easily than metal stabilizers .

###24786017
BACKGROUND	A sildenafil tablet formulation as a PDE-5 inhibitor is widely used for the treatment of erectile dysfunction .
BACKGROUND	Recently , a fine granular formulation of sildenafil was developed by a domestic Korean pharmaceutical company .
OBJECTIVE	This study was performed to compare the bioavailability of sildenafil fine granules with that of sildenafil tablets for assessing bioequivalence in 40 healthy male volunteers .
METHODS	This was an open-label , randomized sequence , single-dose , two-period , and two-treatment crossover study .
METHODS	Half of the volunteers received a single dose of sildenafil fine granule 50 mg and then sildenafil tablet 50 mg after a 7-day washout period .
METHODS	The remaining half of volunteers received the tablet first and the the granule with the same washout period .
METHODS	10 - mL blood samples were serially sampled to measure the concentrations of sildenafil and the N-desmethyl metabolite .
METHODS	Tolerability was assessed during the study .
RESULTS	The pharmacokinetic parameters of sildenafil were similar between granular and tablet formulations .
RESULTS	The 90 % CI of geometric mean ratios ( sildenafil granule/tablet ) for the pharmacokinetic parameters of sildenafil were within 0.8 1.25 , as a bioequivalent acceptable range ; 1.111 ( 90 % CI , 1.002 - 1.231 ) for maximum plasma concentration ( Cmax ) and 1.092 ( 1.019 - 1.117 ) for area under the concentration - time curve from time zero to time of last measurable concentration ( AUClast ) .
RESULTS	Also , the 90 % CI of geometric mean ratios for Cmax and AUClast of the metabolite were within 0.8 - 1.25 .
RESULTS	Both formulations were well tolerated by volunteers .
CONCLUSIONS	This study confirmed that sildenafil granules and sildenafil tablet are bioequivalent with regards to pharmacokinetics of sildenafil and N-desmethyl sildenafil .

###24536058
BACKGROUND	The epidemics of food insecurity , malnutrition , and human immunodeficiency virus ( HIV ) frequently overlap .
BACKGROUND	HIV treatment programs increasingly provide nutrient-dense ready-to-use supplementary foods ( RUSFs ) to patients living with HIV and food insecurity , but in the absence of wasting , it is not known if RUSF confers benefit above less costly food commodities .
METHODS	We performed a randomized trial in rural Haiti comparing an RUSF with less costly corn-soy blend plus ( CSB + ) as a monthly supplement to patients with HIV infection who were on antiretroviral therapy ( ART ) < 24 months prior to study start .
METHODS	We compared 6 - and 12-month outcomes by ration type in terms of immunologic response , body mass index ( BMI ) , adherence to ART , general health quality of life , household food insecurity , and household wealth .
RESULTS	A cohort of 524 patients with HIV receiving ART was randomized and followed over time .
RESULTS	Median CD4 cell count at baseline was 339 cells/L ( interquartile range [ IQR ] , 197-475 cells/L ) for the CSB + group , and 341 cells/L ( IQR , 213-464 / L ) for the RUSF group .
RESULTS	Measured outcomes improved from baseline over time , but there were no statistically significant differences in change for BMI , household wealth index , hunger , general health perception score , or adherence to ART by ration type at 6 or 12 months .
RESULTS	The RUSF group had higher CD4 count at 12 months , but this was also not statistically significant .
CONCLUSIONS	In 12 months of follow-up , there was no statistically significant difference in outcomes between those receiving RUSF-based compared with CSB + - based rations in a cohort of HIV-infected adults on ART in rural Haiti .

###24968543
OBJECTIVE	To study if low dose Unfractionated heparin ( UFH ) is as effective and safe as Low-molecular weight heparin ( LMWH ) and also economical as a prophylactic agent for venous thromboembolism in medically ill patients .
METHODS	A prospective double blind randomised controlled trial consisting of 92 patients fulfilling the inclusion criteria who were admitted to Bangalore Baptist Hospital , Bengaluru , between March 2008 and July 2009 were randomised to receive Unfractionated heparin ( UFH ) or Low-molecular weight heparin ( LMWH ) .
RESULTS	The result based on intention to treat ( ITT ) analysis with best outcome scenario : in the UFH arm there were 47 ( 97.9 % ) patients who had not developed DVT/PE as compared to 42 ( 95.5 % ) in the LMWH arm .
RESULTS	The difference in proportion of patients who had not developed DVT/PE between UFH and LMWH was 2.4 % ( -5.0 , 9.8 ) .
RESULTS	The results based on per protocol analysis : In the UFH arm there were 44 ( 97.8 % ) patients who had not developed DVT/PE as compared to 39 ( 95.1 % ) in the LMWH arm .
RESULTS	The difference in proportion of patients who had not developed DVT/PE between the UFH and LMWH arm was 2.7 % ( -5.2 , 10.5 ) .
RESULTS	Patients on UFH had higher major bleeding complications 4 ( 8.9 % ) as compared to 0 in LMWH arm .
RESULTS	But with respect to other complications like thrombocytopenia ( HIT ) and mild or minimal bleeding both arms were comparable .
CONCLUSIONS	This study has demonstrated that low dose UFH is as effective as LMWH as a prophylactic agent for venous thromboembolism in medically ill patients and economical also .

###24641586
BACKGROUND	Previous studies have shown that treatment with ergocalciferol in patients with CKD stage 3 + 4 is not effective with less than 33 % of patients achieving a 25-OH vitamin D target of > 30 ng/ml .
BACKGROUND	The aim of this study was to test the response to cholecalciferol in CKD .
BACKGROUND	We attempted to replete 25-OH vitamin D to a target level of 40-60 ng/ml using the response to treatment and PTH suppression as an outcome measure .
METHODS	This retrospective cohort study identified patients ( Stages 2-5 and Transplant ) from 2001-2010 who registered at the Chronic Kidney Disease Clinic .
METHODS	Patients received cholecalciferol 10,000 IU capsules weekly as initial therapy .
METHODS	When levels above 40 ng/ml were not achieved , doses were titrated up to a maximum of 50,000 IU weekly .
METHODS	Active vitamin D analogs were also used in some Stage 4-5 CKD patients per practice guidelines .
METHODS	Patients reaching at least one level of 40 ng/mL were designated RESPONDER , and if no level above 40 ng/mL they were designated NON-RESPONDER .
METHODS	Patients were followed for at least 6 months and up to 5 years .
RESULTS	352 patients were included with a mean follow up of 2.4 years .
RESULTS	Of the CKD patients , the initial 25-OH vitamin D in the NON-RESPONDER group was lower than the RESPONDER group ( 18 vs. 23 ng/ml ) ( p = 0.03 ) .
RESULTS	Among all patients , the initial eGFR in the RESPONDER group was significantly higher than the NON-RESPONDER group ( 36 vs. 30 ml/min/1 .73 m2 ) ( p < 0.001 ) .
RESULTS	Over time , the eGFR of the RESPONDER group stabilized or increased ( p < 0.001 ) .
RESULTS	Over time , the eGFR in the NON-RESPONDER group decreased toward a trajectory of ESRD .
RESULTS	Proteinuria did not impact the response to 25-OH vitamin D replacement therapy .
RESULTS	There were no identifiable variables associated with the response or lack of response to cholecalciferol treatment .
CONCLUSIONS	CKD patients treated with cholecalciferol experience treatment resistance in raising vitamin D levels to a pre-selected target level .
CONCLUSIONS	The mechanism of vitamin D resistance remains unknown and is associated with progressive loss of eGFR .
CONCLUSIONS	Proteinuria modifies but does not account for the vitamin D resistance .

###25056511
OBJECTIVE	The clinical outcomes for patients with worsening chronic heart failure ( WCHF ) remain exceedingly poor despite contemporary evidence-based therapies , and effective therapies are urgently needed .
OBJECTIVE	Accumulating evidence supports augmentation of cyclic guanosine monophosphate ( cGMP ) signalling as a potential therapeutic strategy for HF with reduced or preserved ejection fraction ( HFrEF and HFpEF , respectively ) .
OBJECTIVE	Direct soluble guanylate cyclase ( sGC ) stimulators target reduced cGMP generation due to insufficient sGC stimulation and represent a promising method for cGMP enhancement .
METHODS	The phase II SOluble guanylate Cyclase stimulatoR in heArT failurE Study ( SOCRATES ) programme consists of two randomized , parallel-group , placebo-controlled , double-blind , multicentre studies , SOCRATES-REDUCED ( in patients with LVEF < 45 % ) and SOCRATES-PRESERVED ( in those with LVEF 45 % ) , that will explore the pharmacodynamic effects , safety and tolerability , and pharmacokinetics of four dose regimens of the once-daily oral sGC stimulator vericiguat ( BAY 1021189 ) over 12 weeks compared with placebo .
METHODS	These studies will enrol patients stabilized during hospitalization for HF at the time of discharge or within 4 weeks thereafter .
METHODS	The primary endpoint in SOCRATES-REDUCED is change in NT-proBNP at 12 weeks .
METHODS	The primary endpoints in SOCRATES-PRESERVED are change in NT-proBNP and left atrial volume at 12 weeks .
CONCLUSIONS	SOCRATES will be the first programme to enrol specifically both inpatients and outpatients with WCHF and patients with reduced or preserved ejection fraction .
CONCLUSIONS	Results will inform the benefits of pursuing subsequent event-driven clinical outcome trials with sGC stimulators in this patient population .

###24375223
BACKGROUND	Tranversus-abdominis plane ( TAP ) block is a novel technique alternative to central neural blockade in providing analgesia to the anterior abdominal wall .
BACKGROUND	As such , we compared the analgesic efficacy of TAP block with low thoracic-epidural analgesia ( TEA ) in ischemic heart disease patients after abdominal laparotomy .
METHODS	Forty-four American Society of Anesthesiologists physical status ( ASA ) III patients , 59-75 years of age and undergoing elective upper abdominal surgery under general anesthesia , were assigned randomly to receive either continuous low TEA or intermittent administration of local anesthetic in TAP block .
METHODS	Supplemental analgesia was provided with intravenous morphine with patient-controlled-analgesia .
METHODS	Morphine consumption and pain intensity using verbal rating scale ( VRS ) at rest and coughing over the first 48 h were recorded .
RESULTS	Whereas all patients in the TAP group required morphine , 16 ( 72.2 % ) patients in TEA group received morphine postoperatively ( p = 0.021 ) .
RESULTS	Morphine consumed on day 1 and day 2 was 11.5 mg ( 7.5-12 .3 mg ) and 7 mg ( 4.5-8 mg ) for the TEA group , while in the TAP group , it was 18 mg ( 16-19 mg ) and 11 mg ( 10-13 mg ) , respectively ( p < 0.001 ) .
RESULTS	Time for first request of morphine was 311.2 18.5 min in the TEA group versus 210 22.2 min in the TAP group ( p < 0.001 ) .
RESULTS	VRS at rest and cough were lower in the TEA group compared with the TAP group at 1 , 6 , 12 , 18 , 24 , 36 and 48 h ( p < 0.001 ) .
RESULTS	Incidence of hypotension and ephedrine administration were significantly higher in the TEA group than in the TAP group ( p = 0.007 ) .
CONCLUSIONS	Low TEA reduced morphine consumption and provided a higher analgesic efficacy compared with TAP block after laparotomy in ischemic heart disease patients .

###24862623
OBJECTIVE	Bronchiolitis is one of the most common and costly respiratory diseases in infants and young children .
OBJECTIVE	Previous studies have shown a potential benefit of nebulized hypertonic saline ; however , its effect in the emergency department ( ED ) setting is unclear .
OBJECTIVE	To compare the effect of nebulized 3 % hypertonic saline vs 0.9 % normal saline on admission rate and length of stay in infants with bronchiolitis .
METHODS	We conducted a double-blind , randomized clinical trial during 3 consecutive bronchiolitis seasons from March 1 , 2008 , through April 30 , 2011 .
METHODS	We recruited a convenience sample of patients younger than 24 months with a primary diagnosis of viral bronchiolitis presenting to the ED of 2 urban free-standing tertiary children 's hospitals .
METHODS	We excluded patients who were premature ( gestational age , < 34 weeks ) or who had chronic pulmonary disease , immune deficiency , cardiac disease , or previous episodes of wheezing or inhaled bronchodilator use .
METHODS	Of eligible patients who were approached , 161 ( 26.6 % ) declined to participate .
METHODS	Patients received 4 mL of 3 % sodium chloride ( hypertonic saline [ HS group ] ) or 0.9 % sodium chloride ( normal saline [ NS group ] ) inhaled as many as 3 times in the ED .
METHODS	Those admitted received the assigned medication every 8 hours until discharge .
METHODS	All treatment solutions were premedicated with albuterol sulfate .
METHODS	Hospital admission rate , length of stay for admitted patients , and Respiratory Distress Assessment Instrument score .
RESULTS	A total of 197 patients were enrolled in the NS group and 211 in the HS group .
RESULTS	Admission rate in the 3 % HS group was 28.9 % compared with 42.6 % in the NS group ( adjusted odds ratio from logistic regression , 0.49 [ 95 % CI , 0.28-0 .86 ] ) .
RESULTS	Mean ( SD ) length of stay for hospitalized patients was 3.92 ( 5.24 ) days for the NS group and 3.16 ( 2.11 ) days for the HS group ( P = .24 ) .
RESULTS	The Respiratory Distress Assessment Instrument score decreased after treatment in both groups ; however , we found no significant difference between groups ( P = .35 ) .
CONCLUSIONS	Hypertonic saline given to children with bronchiolitis in the ED decreases hospital admissions .
CONCLUSIONS	We can detect no significant difference in Respiratory Distress Assessment Instrument score or length of stay between the HS and NS groups .
BACKGROUND	clinicaltrials.gov Identifier : NCT00619918 .

###24364373
OBJECTIVE	This study aimed to examine diabetes self-care ( DSC ) patterns in low-income African American and Latino patients with Type 2 diabetes , and identify patient-related , biomedical/disease-related , and psychosocial correlates of DSC .
METHODS	We performed cross-sectional analysis of survey data from African Americans and Latinos aged 18 years with Type 2 diabetes ( n = 250 ) participating in a diabetes self-management intervention at 4 primary care clinics .
METHODS	The Summary of Diabetes Self-Care Activities captured the subcomponents of healthy eating , physical activity , blood sugar testing , foot care , and smoking .
METHODS	Correlates included patient-related attributes , biomedical/disease-related factors , and psychosocial constructs , with their multivariable influence assessed with a 3-step model building procedure using regression techniques .
RESULTS	Baseline characteristics were as follows : mean age of 53 years ( SD = 12.4 ) ; 69 % female ; 53 % African American ; 74 % with incomes below $ 20,000 ; and 60 % with less than a high school education .
RESULTS	DSC performance levels were highest for foot care ( 4.5 / 7 days ) and lowest for physical activity ( 2.5 / 7 days ) .
RESULTS	Across racial/ethnic subgroups , diabetes-related distress was the strongest correlate for DSC when measured as a composite score .
RESULTS	Psychosocial factors accounted for 14 % to 33 % of variance in self-care areas for both racial/ethnic groups .
RESULTS	Patient characteristics were more salient correlates in Hispanic/Latinos when examining the self-care subscales , particularly those requiring monetary resources .
CONCLUSIONS	Important information is provided on specific DSC patterns in a sample of ethnic/racial minorities with Type 2 diabetes .
CONCLUSIONS	Significant correlates found may help with identification and intervention of patients who may benefit from strategies to increase self-care adherence .

###26098004
OBJECTIVE	Indications for home treatment for specific diagnoses in child and adolescent psychiatry have not yet been evaluated .
METHODS	In a recent intervention study ( primary outcome : length of stay ) , 92 patients aged 5 to 17 years were randomized into an intervention group ( early discharge followed by home treatment in combination with inpatient treatment , where needed ) and a control group ( regular length inpatient treatment ) .
METHODS	The aim of this explorative analysis was to retrieve additional information on what works for whom .
METHODS	Outcome parameters were as follows : Childrens Global Assessment Scale ( CGAS ) , Health of the Nation Outcome Scales for Children and Adolescents ( HoNOSCA ) , Strengths and Difficulties Questionnaire ( SDQ ) and Columbia Impairment Scale ( CIS ) at T1 ( within 14 days after intake ) , T2 ( end of treatment ) and T3 ( 8.4-month follow-up ) .
METHODS	Multiple regression was used to investigate the association between diagnoses , treatment setting , age , sex , and improvement in both groups .
RESULTS	In children externalizing disorders were predominant , whereas in adolescents internalizing disorders were prominent .
RESULTS	Patients improved equally under both types of treatment .
RESULTS	Home treatment , however , was rated by the patients to be significantly more effective in adolescents ( SDQ p = .017 ) , boys ( CIS p = .009 , SDQ p < .001 ) , and with externalizing disorders ( SDQ p = .005 ) .
CONCLUSIONS	Home treatment may be considered an alternative to inpatient treatment , especially in boys with externalizing disorders .

###25243960
OBJECTIVE	To evaluate the efficacy of Fuzhenghuayu capsule for the prevention of oesophageal variceal bleeding in patients with liver cirrhosis .
METHODS	A multicentre randomized placebo-controlled trial was conducted .
METHODS	A total of 181 liver cirrhosis patients were enrolled in the study and randomly assigned to different groups according to the level of oesophageal variceal bleeding .
METHODS	Patients with light oesophageal varices received Fuzhenghuayu capsule or a placebo .
METHODS	Patients with medium to heavy oesophageal varices received either Fuzhenghuayu capsule alone , Fuzhenghuayu capsule plus propranolol , or propranolol plus a placebo .
METHODS	Patients with a history of oesophageal variceal bleeding received either Fuzhenghuayu capsule plus propranolol , propranolol alone , or a placebo .
METHODS	For all patients , the treatment lasted 2 years .
METHODS	The primary end point of the study was oesophageal variceal bleeding .
METHODS	The secondary end points were liver cancer , death by any cause , and liver transplantation .
METHODS	Risk of bleeding and survival were statistically assessed .
RESULTS	The median follow-up time was 50 months .
RESULTS	The patients with small oesophageal varices who were treated with Fuzhenghuayu capsule showed a significantly higher cumulative probability of bleeding than their counterparts treated with the placebo ( 3.4 % vs. 23.7 % , x = 4.829 , P = 0.028 ) .
RESULTS	The patients with medium to heavy oesophageal varices and no history of oesophageal variceal bleeding who were treated with Fuzhenghuayu capsule plus propranolol showed a remarkably higher cumulative probability of bleeding than their counterparts treated with propranolol alone ( 15.2 % vs. 43.6 % , x = 6.166 , P = 0.013 ) .
RESULTS	There were no significant differences between the patients treated with Fuzhenghuayu capsule alone and those treated with propranolol alone ( P = 0.147 ) or the patients treated with Fuzhenghuayu capsule plus propranolol and those treated with Fuzhenghuayu capsule alone ( P = 0.147 ) .
RESULTS	The patients with history of oesophageal variceal bleeding who were treated with Fuzhenghuayu capsule showed significantly higher cumulative probability of bleeding and median time of bleeding than their counterparts treated with propranolol alone ( 44.0 % vs. 24.2 % and 40.00 17.92 months vs. 7.00 2.35 months ; x = 4.433 , P = 0.035 ) .
RESULTS	There were no significant differences in the cumulative probability of liver cancer and survival among all of the groups .
CONCLUSIONS	Fuzhenghuayu capsule can decrease the cumulative probability of bleeding in cirrhotic patients with light oesophageal varices .
CONCLUSIONS	For cirrhosis patients with a history of oesophageal variceal bleeding , the combination of Fuzhenghuayu capsule plus propranolol can decrease the cumulative probability of bleeding with median or heavy varices .

###25169211
BACKGROUND	The periodic health check-up has been a fundamental part of routine medical practice for decades , despite a lack of consensus regarding its value in health promotion and disease prevention .
BACKGROUND	A large-scale Danish population-based preventive programme ` Check your health ' was developed based on available evidence of screening and successive accepted treatment , prevention for diseases and health promotion , and is closely aligned with the current health care system.The objective of the ` Check your health ' [ CORE ] trial is to investigate effectiveness on health outcomes of a preventive health check offered at a population-level to all individuals aged 30-49 years , and to establish the cost-effectiveness .
METHODS	The trial will be conducted as a pragmatic household-cluster randomised controlled trial involving 10,505 individuals .
METHODS	All individuals within a well-defined geographical area in the Central Denmark Region , Denmark ( DK ) were randomised to be offered a preventive health check ( Intervention group , n = 5250 ) or to maintain routine access to healthcare until a delayed intervention ( Comparison group , n = 5255 ) .
METHODS	The programme consists of a health examination which yields an individual risk profile , and according to this participants are assigned to one of the following interventions : ( a ) referral to a health promoting consultation in general practice , ( b ) behavioural programmes at the local Health Centre , or ( c ) no need for follow-up .
METHODS	The primary outcomes at 4 years follow-up are : ten-year-risk of fatal cardiovascular event ( Heart-SCORE model ) , physical activity level ( self-report and cardiorespiratory fitness ) , quality of life ( SF12 ) , sick leave and labour market attachment .
METHODS	Cost-effectiveness will be evaluated according to life years gained , direct costs and total health costs .
METHODS	Intention to treat analysis will be performed .
CONCLUSIONS	Results from the largest Danish health check programme conducted within the current healthcare system , spanning the sectors which share responsibility for the individual , will provide a scientific basis to be used in the development of systems to optimise population health in the 21st century .
BACKGROUND	The trial has registered at ClinicalTrials.gov with an ID : NCT02028195 ( 7 .
BACKGROUND	March 2014 ) .

###24406537
OBJECTIVE	The randomized , double-blind Third International Study on Syncope of Uncertain Etiology ( ISSUE-3 ) showed that dual-chamber permanent pacing was effective in reducing the recurrence of syncope in patients 40 years with severe asystolic , probably neurally mediated syncope ( NMS ) , documented by implantable loop recorder ( ILR ) .
OBJECTIVE	Analysis in ISSUE-3 was performed according to the intention-to-treat principle .
OBJECTIVE	In the present study , we performed an on-treatment analysis , which included additionally those non-randomized patients followed up in the ISSUE registry to evaluate in a better manner the effectiveness of cardiac pacing therapy .
RESULTS	Initially , 504 patients received an ILR , 162 ( 32 % ) patients had a diagnosis consistent with NMS within a mean observation period of 15 11 months : 99 ( 19 % ) patients had documentation of syncope with 3 s asystole or 6 s asystole without syncope .
RESULTS	Sixty patients affected by asystolic NMS received cardiac pacing therapy and 86 ( 33 asystolic and 53 non-asystolic NMS ) were untreated ; 16 patients were lost to follow-up .
RESULTS	Paced and unpaced groups had similar clinical characteristics .
RESULTS	During subsequent follow-up , syncope recurred in 10 paced ( 17 % ) and in 40 non-paced ( 46 % ) patients .
RESULTS	At 21 months , the estimated product-limit syncope recurrence rates were 27 % [ 95 % confidence interval ( CI ) 15-47 ] and 54 % ( 95 % CI 43-67 ) , respectively ( P = 0.01 ) .
RESULTS	With cardiac pacing , the risk of recurrence was reduced by 57 % ( hazard ratio = 0.43 , 95 % CI = 0.2-0 .8 ) .
RESULTS	Complications of pacemaker therapy were haemothorax at implantation in one patient and lead dislodgement that required correction in two patients .
CONCLUSIONS	Permanent cardiac pacing is effective in reducing recurrence of syncope in patients 40 years with severe asystolic possible NMS with a few complications .
CONCLUSIONS	The study shows that 61 % of patients with a diagnosis of NMS made by ILR received a pacemaker but 5.1 ILRs had to be implanted to find one patient who finally had a pacemaker implanted .

###24377640
BACKGROUND	In the literature , data concerning the relationship between breast cancer and HLA class II gene polymorphisms are limited , so the aim of this study was to determine if HLA-DQB1 and HLA-DRB1 MHC class-II alleles may confer susceptibility or resistance to the disease among Jordanian females .
METHODS	This case control study enrolled 56 Royal Hospital breast cancer patients and 60 age matched healthy controls , all of whom provided blood samples ( 2011-2013 ) .
METHODS	A questionnaire was filled after signing a consent form and DNA was extracted , nucleic acids being amplified for assessment of HLA-DQB1 and HLA-DRB1 alleles by muliplex INNO-LiPA and allele typing carried out by reverse hybridization .
METHODS	Comparison of HLA-DQB1 and HLA-DRB1 allele distributions was carried out with paired t-test and chi-square statistics .
METHODS	Risk factors were assessed by odd ratios with 95 % confidence intervals .
RESULTS	A significant negative correlation was observed between HLADQB1 * 02 alleles and breast cancers ( p = 0.013 ) .
RESULTS	No significant associations were observed among HLADQB1 * 03 , 04 , 05 and 06 or among HLA-DRB1 * 01 , 03 , 04 , 07 , 08 , 10 , 11 , 13 , 14 and 15 .
CONCLUSIONS	HLADQB1 * 02 alleles may provide positive protection against breast tumor risk among Jordanians , but not HLADQB1 * 03 , 04 , 05 and 06 or HLA-DRB1 * 01 , 03 , 04 , 07 , 08 , 10 , 11 , 13 , 14 and 15 alleles .

###26042920
OBJECTIVE	Intuitive eating is an eating approach that emphasizes increased focus on internal hunger and fullness cues to regulate eating behavior ; thus , successful intuitive eating should curb the influence of environmental factors such as plate and portion size on consumption .
OBJECTIVE	The current study examined whether self-reported levels of intuitive eating moderated the influence of portion size on college students ' food consumption during an afternoon meal of pasta and tomato sauce .
METHODS	Participants ( N = 137 , 63.5 % female ) were randomly assigned to either a large plate ( 12-inch ) or small plate ( 8-inch ) external cue condition .
METHODS	All participants fasted for four daytime hours , completed the Intuitive Eating Scale , and then were asked to rate a meal of pasta and tomato sauce on different dimensions of taste .
METHODS	Participants were told that they could eat as much pasta as they would like .
RESULTS	Higher levels of intuitive eating were associated with greater food consumption .
RESULTS	At the mean level of intuitive eating , participants ate more pasta in the large plate condition .
RESULTS	Furthermore , the influence of plate size on food consumption increased as levels of intuitive eating increased .
CONCLUSIONS	Individuals who report high levels of intuitive eating may be more likely to eat an objectively larger amount of food in a permissive food environment , and may have implications for eating approaches that promote eating in response to internal hunger and fullness cues .

###24642116
BACKGROUND	Lactate measurement has been used to identify critical medical illness and initiate early treatment strategies .
BACKGROUND	The prehospital environment offers an opportunity for very early identification of critical illness and commencement of care .
OBJECTIVE	The investigators hypothesized that point-of-care lactate measurement in the prehospital aeromedical environment would : ( 1 ) identify medical patients with high mortality ; ( 2 ) influence fluid , transfusion , and intubation ; and ( 3 ) increase early central venous catheter ( CVC ) placement .
METHODS	Critically ill , medical , nontrauma patients who were transported from September 2007 through February 2009 by University of Massachusetts ( UMass ) Memorial LifeFlight , a university-based emergency medical helicopter service , were eligible for enrollment .
METHODS	Patients were prospectively randomized to receive a fingerstick whole-blood lactate measurement on an alternate-day schedule .
METHODS	Flight crews were not blinded to results .
METHODS	Flight crews were asked to inform the receiving attending physician of the results .
METHODS	The primary endpoint was the ability of a high , prehospital lactate value [ > 4 millimoles per liter ( mmol/L ) ] to identify mortality .
METHODS	Secondary endpoints included differences in post-transport fluid , transfusion , and intubation , and decrease in time to central venous catheter ( CVC ) placement .
METHODS	Categorical variables were compared between groups by Fisher 's Exact Test , and continuous variables were compared by t-test .
RESULTS	Patients ( N = 59 ) were well matched for age , gender , and acuity .
RESULTS	In the lactate cohort ( n = 20 ) , mean lactate was 7 mmol/L [ Standard error of the mean , SEM = 1 ] .
RESULTS	Initial analysis revealed that prehospital lactate levels of 4 mmol/L did show a trend toward higher mortality with an odds ratio of 2.1 ( 95 % CI , 0.3-13 .8 ) .
RESULTS	Secondary endpoints did not show a statistically significant change in management between the lactate and non lactate groups .
RESULTS	There was a trend toward decreased time to post-transport CVC in the non lactate faction .
CONCLUSIONS	Prehospital aeromedical point-of-care lactate measurement levels 4 mmol/L may help stratify mortality .
CONCLUSIONS	Further investigation is needed , as this is a small , limited study .
CONCLUSIONS	The initial analysis did not find a significant change in post-transport management .

###25143156
BACKGROUND	Online interventions have emerged as a popular strategy to promote healthy behaviors .
BACKGROUND	Currently , there is little agreement about how to capture online intervention engagement .
BACKGROUND	It is also uncertain who engages with weight-related online interventions and how engagement differs by demographic and weight characteristics .
OBJECTIVE	The objectives of this study were to ( 1 ) characterize how pregnant women engaged with features of an online intervention to prevent excessive gestational weight gain , ( 2 ) identify demographic and weight status subgroups of women within the sample , and ( 3 ) examine differences in use of intervention features across the demographic and weight status subgroups .
METHODS	A sample of racially and socioeconomically diverse pregnant women from a northeastern US city was assigned to the intervention group in a randomized controlled trial to prevent excessive gestational weight gain ( n = 1014 ) .
METHODS	The intervention website included these features : weight-gain tracker , health-related articles , blogs , physical activity and diet goal-setting tools , and local resources .
METHODS	Engagement variables were created to capture the amount , consistency , and patterns of feature use across pregnancy using latent class analysis .
METHODS	Demographic/weight status subgroups were also created using latent class analysis .
METHODS	Differences in engagement across the demographic/weight status subgroups were examined using chi-square analysis .
RESULTS	Six engagement patterns emerged : `` super-users '' ( 13.02 % , 132/1014 ) , `` medium-users '' ( 14.00 % , 142/1014 ) , `` consistent weight-tracker users '' ( 14.99 % , 152/1014 ) ; `` almost consistent weight-tracker users '' ( 21.99 % , 223/1014 ) , `` inconsistent weight-tracker users '' ( 15.98 % , 162/1014 ) , and `` non-users '' ( 20.02 % , 203/1014 ) .
RESULTS	Four demographic/weight status subgroups emerged : three minority and one white .
RESULTS	There were different engagement patterns by demographic/weight status subgroups .
RESULTS	Super-users were more likely to be in the white subgroup , while non-users were more likely to be in the minority subgroups .
RESULTS	However , around a third of women in minority subgroups were consistently or almost consistently engaging with the weight-tracker ( black , young women , 32.2 % , 67/208 ; black , heavier women , 37.9 % , 50/132 ; Hispanic women , 27.4 % , 32/117 ) .
CONCLUSIONS	While white and higher income women had higher engagement in general , depending on the measure , there was still considerable engagement by the minority and low-income women .
BACKGROUND	Clinicaltrials.gov : NCT01331564 ; http://clinicaltrials.gov/ct2/show/NCT01331564 ( Archived by WebCite at http://www.webcitation.org/6Rw4yKxI5 ) .

###25488090
OBJECTIVE	To test whether supervised pelvic floor exercises antenatally will reduce the incidence of postpartum stress incontinence in at-risk primigravidae with bladder neck mobility , ultrasonically proven .
METHODS	Single blind , randomised controlled trial .
METHODS	Antenatal clinic in a UK NHS Trust Hospital .
METHODS	Two hundred and sixty-eight primigravidae attending an antenatal clinic at approximately 20 weeks of gestation with bladder neck mobility , on standardised valsalva , of 5 mm or more linear movement .
METHODS	The median age was 28 , ranging from 16 to 47 years .
METHODS	Patients randomised to supervised pelvic floor exercises ( n = 139 ) attended a physiotherapist at monthly intervals from 20 weeks until delivery .
METHODS	The exercises comprised three repetitions of eight contractions each held for six seconds , with two minutes rest between repetitions .
METHODS	These were repeated twice daily .
METHODS	At 34 weeks of gestation the number of contractions per repetition was increased to 12 .
METHODS	Both the untreated control group and the study group received verbal advice on pelvic floor exercises from their midwives antenatally .
METHODS	Subjective reporting of stress incontinence at three months postpartum .
METHODS	Pelvic floor strength , using perineometry , and bladder neck mobility measured by perineal ultrasound .
RESULTS	Of the 268 women enrolled , information on the main outcome variable was available for 110 in the control group and 120 in the study group .
RESULTS	Fewer women in the supervised pelvic floor exercise group reported postpartum stress incontinence , 19.2 % compared with 32.7 % in the control group ( RR 0.59 [ 0.37-0 .92 ] ) .
RESULTS	There was no change in bladder neck mobility and no difference in pelvic floor strength between groups after exercise , although all those developing postpartum stress incontinence had significantly poorer perineometry scores than those who were continent .
CONCLUSIONS	The findings suggest that antenatal supervised pelvic floor exercises are effective in reducing the risk of postpartum stress incontinence in primigravidae with bladder neck mobility .

###24579432
OBJECTIVE	The aim of the present study was to evaluate the procedural feasibility , the safety and the 1-year outcome following left atrial appendage ( LAA ) closure using the Amplatzer cardiac plug ( ACP ) in Belgium .
RESULTS	Data were prospectively collected among 90 consecutive patients , undergoing LAA closure with an ACP in 7 Belgian centres between June 2009 and September 2012 .
RESULTS	The patients ( 56 males , 74 + / - 8 years ) were at high risk for stroke ( CHA2DS2-VASc = 4.4 + / - 1.8 ) and bleeding ( HAS-BLED = 3.3 + / - 1.3 ) .
RESULTS	Technical success was obtained in all but one patient and procedural success was 95 % .
RESULTS	Procedural major adverse events ( MAE ) were 3 tamponades resulting in death in one case .
RESULTS	Minor complications were 3 insignificant pericardial effusions , 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm .
RESULTS	At 1-y follow-up , there were 4 deaths , 2 minor strokes , 1 tamponade and 1 myocardial infarction .
RESULTS	Overall survival was 94 % and freedom from MAE was 88 % .
RESULTS	In our population , the expected annual stroke risk according to the CHA2DS2-VASc score was 5.08 % , while the observed stroke rate was 2.14 % / year .
CONCLUSIONS	The Belgian registry shows that LAA closure using the ACP device is feasible and safe .
CONCLUSIONS	At 1-y follow-up , the observed stroke rate was 2.14 % / year , less than predicted by the CHA2DS2-VASc score .
CONCLUSIONS	Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke .

###25867783
BACKGROUND	Self-monitoring by mobile phone applications offers new opportunities to engage patients in self-management .
BACKGROUND	Self-monitoring has not been examined thoroughly as a self-directed intervention strategy for self-management of multiple behaviors and states by people living with HIV ( PLH ) .
METHODS	PLH ( n = 50 ) , primarily African American and Latino , were recruited from 2 AIDS services organizations and randomly assigned to daily smartphone ( n = 34 ) or biweekly Web-survey only ( n = 16 ) self-monitoring for 6 weeks .
METHODS	Smartphone self-monitoring included responding to brief surveys on medication adherence , mental health , substance use , and sexual risk behaviors , and brief text diaries on stressful events .
METHODS	Qualitative analyses examine biweekly open-ended user-experience interviews regarding perceived benefits and barriers of self-monitoring , and to elaborate a theoretical model for potential efficacy of self-monitoring to support self-management for multiple domains .
RESULTS	Self-monitoring functions include reflection for self-awareness , cues to action ( reminders ) , reinforcements from self-tracking , and their potential effects on risk perceptions , motivations , skills , and behavioral activation states .
RESULTS	Participants also reported therapeutic benefits related to self-expression for catharsis , nonjudgmental disclosure , and in-the-moment support .
RESULTS	About one-third of participants reported that surveys were too long , frequent , or tedious .
RESULTS	Some smartphone group participants suggested that daily self-monitoring was more beneficial than biweekly due to frequency and in-the-moment availability .
RESULTS	About twice as many daily self-monitoring group participants reported increased awareness and behavior change support from self-monitoring compared with biweekly Web-survey only participants .
CONCLUSIONS	Self-monitoring is a potentially efficacious disruptive innovation for supporting self-management by PLH and for complementing other interventions , but more research is needed to confirm efficacy , adoption , and sustainability .

###24451865
OBJECTIVE	The purpose of this study was to compare the clinical efficacy of an anorganic bovine bone graft particulate to that of a calcium phosphosilicate putty alloplast for socket preservation .
METHODS	Thirty teeth were extracted from 24 patients .
METHODS	The sockets were debrided and received anorganic bovine bone mineral ( BOV , n = 12 ) , calcium phosphosilicate putty ( PUT , n = 12 ) , or no graft ( CTRL , n = 6 ) .
METHODS	The sockets were assessed clinically and radiographically 5 months later .
METHODS	Eight sockets in the BOV group and nine in the PUT group received implants 5 to 6 months postgrafting .
METHODS	The maximum implant insertion torque ( MIT ) was measured as an index of primary implant stability .
METHODS	The data were analyzed with the Mann-Whitney test .
RESULTS	Both test groups had statistically significantly less reduction in mean ridge width ( BOV : 1.390.57 mm ; PUT : 1.260.41 mm ) in comparison to the control group ( 2.530.59 mm ) .
RESULTS	No statistically significant difference was identified between the test groups .
RESULTS	MIT for PUT was 35 N/cm ( MIT grade 4 ) for seven of the nine implants .
RESULTS	MIT values in the BOV group ranged from grade 1 ( 10 to 19 N/cm ) to grade 4 , which was statistically significantly lower than for the PUT group .
RESULTS	The overall implant success rate was 94.1 % ( 16 of 17 implants were successful ) .
RESULTS	No implants were lost in the PUT group ; one implant failed in the BOV group .
CONCLUSIONS	Both tested bone substitutes can be recommended for preservation of alveolar ridge width following extraction .
CONCLUSIONS	PUT might be more suitable for achieving primary stability for implants placed at 5 to 6 months postextraction .

###25424602
OBJECTIVE	There is convincing evidence that unsaturated fatty acids exert favourable effects on plasma cholesterol levels .
OBJECTIVE	However , it is not clear which type of oil has the most pronounced effect , especially not in paediatric patients .
OBJECTIVE	The aim was to compare two low-fat diet regimes enriched with either monounsaturated fatty acids by rapeseed oil ( RO ) or polyunsaturated fatty acids by sunflower oil ( SO ) in children affected with familial hypercholesterolaemia ( FH ) .
METHODS	Twenty-one children aged 6-18 years affected with FH were enrolled in this randomized and double-blind pilot trial .
METHODS	The subjects and their families were trained to adhere to a low-fat/low-cholesterol diet .
METHODS	All visible fats were to be replaced by either RO or SO ( 14-27g / day ) for 13 weeks .
METHODS	Dietary adherence was controlled by repeated 4-day dietary records ; plasma lipids , lipoproteins and risk markers were assessed at baseline and post-intervention .
METHODS	Out of 21 subjects , 16 could be followed-up after 6 months .
RESULTS	Both fat-modified diets resulted in significant reduction in total cholesterol concentrations of 9.4 % ( RO P < 0.005 vs SO P < 0.05 ) and low-density lipoprotein ( LDL ) cholesterol concentrations of 12.7 % ( P < 0.005 ) for RO and 11.3 % ( P < 0.05 ) for SO .
RESULTS	The reduction of the LDL/high-density lipoprotein ( HDL ) cholesterol ratio ( RO 9 % vs SO 3.5 % ) and high-sensitivity C-reactive protein ( RO 16.8 % vs SO 1.7 % ) were not statistically significant , respectively .
RESULTS	In most participating families , a change in eating habits could be observed .
CONCLUSIONS	A fat-modified diet enriched with RO seems to have very similar effects on cholesterol levels as with SO .
CONCLUSIONS	However , our study suggests that RO has possibly more favourable effects concerning cardiovascular risk profile .
CONCLUSIONS	Both diets appear to be feasible and were well accepted among our subjects .
CONCLUSIONS	Although these results are promising , larger trials will be required to validate our findings .

###25321188
BACKGROUND	The present analysis describes the longitudinal change in buprenorphine treatment outcome .
BACKGROUND	It also examines several participant characteristics to predict response to buprenorphine .
METHODS	Participants ( n = 501 , age > 15 years ) received buprenorphine/naloxone treatment for 4 weeks , and then were randomly assigned to undergo dose tapering over either 7 days or 28 days .
METHODS	An empirical model was developed to describe the longitudinal changes in treatment outcome .
METHODS	Several patient characteristics were also examined as possible factors influencing treatment outcome .
RESULTS	We have developed a model that captures the general behavior of the longitudinal change in the probability of having an opioid-negative urine sample following buprenorphine treatment .
RESULTS	The model captures both the initial increase ( i.e. , initial response ) and the subsequent decrease ( i.e. , relapse to opioid ) in the likelihood of providing an opioid-negative urine sample .
RESULTS	Characteristics associated with successful buprenorphine treatment outcome include : having a negative urine test for drugs , having alcohol problems [ assessed using alcohol domain of addiction severity index ( ASI-alcohol ) ] at screening , being older , and receiving low cumulative buprenorphine dose .
RESULTS	However , ASI-alcohol values were generally low which make the application of the proposed alcohol effect for patients with more severe alcohol problems questionable .
CONCLUSIONS	A novel approach for analyzing buprenorphine treatment outcome is presented in this manuscript .
CONCLUSIONS	This approach describes the longitudinal change in the probability of providing an opioid-free urine sample instead of considering opioid use outcome at a single time point .
CONCLUSIONS	Additionally , this model successfully describes relapse to opioid .
CONCLUSIONS	Finally , several patient characteristics are identified as predictors of treatment outcome .

###24710248
BACKGROUND	We compared the quantitative clinical performances of the streamlined liner of the pharynx airway ( SLIPA ) and the ProSeal laryngeal mask airway ( LMA ProSeal ) regarding intensity of gastric distension in patients undergoing laparoscopic cholecystectomy .
METHODS	A total of 124 anesthetized , paralyzed patients ( ASA 1 to 2 ; aged , 18 to 80 y ) were randomly allocated for airway management with the SLIPA or LMA ProSeal .
METHODS	After induction of general anesthesia using total intravenous anesthesia and rocuronium , the intensity of gastric distension was accessed twice by 2 raters , respectively .
METHODS	We also compared the fiberoptic bronchoscopic view of the glottis , the severity of blood stain , and postoperative sore throat .
RESULTS	There were no statistically significant differences between groups for each gastric size .
RESULTS	The change of gastric size within the SLIPA group was not statistically significant for both raters .
RESULTS	Change within the LMA ProSeal group was significant in rater 2 ( P = 0.045 ) and marginally significant for rater 1 ( P = 0.056 ) .
RESULTS	Anatomic fit , complications during emergence , and the severity of blood stain and postoperative sore throat were similar in both groups .
CONCLUSIONS	SLIPA is as efficacious as LMA ProSeal for use in patients without severe complications who are undergoing laparoscopic cholecystectomy .

###25543127
OBJECTIVE	To investigate the effectiveness of brief intervention ( BI ) conducted in the workplace for heavy drinkers .
METHODS	A randomized controlled trial was conducted at six companies in Japan .
METHODS	Participants were heavy drinkers who met the inclusion criteria and were randomized into three groups : the BI group , BI with diary group and a control group .
METHODS	Outcomes ( total drinks , binge drinking episodes and alcohol-free days ) were evaluated at 3 and 12 months .
RESULTS	The 304 participants recruited were allocated to the three groups and 277 participated in all follow-up evaluations .
RESULTS	Dropout rates in the respective groups were 7.0 , 14.9 and 5.5 % .
RESULTS	Some improvements were observed in all the groups .
RESULTS	In particular , alcohol-free days in the BI group were significantly increased by 93.0 % at 12 months .
RESULTS	Total drinks at 12 months were reduced by 41 g per week in the BI group compared with the control group , although the intergroup difference was not significant .
CONCLUSIONS	BI in the workplace is effective for increasing the number of alcohol-free days .
CONCLUSIONS	However , the effectiveness on decreasing alcohol consumption was unclear , which could be explained by alcohol screening itself causing a reduction in drinking .

###24920915
BACKGROUND	Several observational studies were conducted with vildagliptin in patients with type 2 diabetes mellitus ( T2DM ) fasting during Ramadan , showing significantly lower incidences of hypoglycemia with vildagliptin versus sulfonylureas , including gliclazide .
BACKGROUND	It was of interest to complement the existing real-life evidence with data from a randomized , double-blind , clinical trial .
BACKGROUND	NCT01758380 .
METHODS	This multiregional , double-blind study randomized 557 patients with T2DM ( mean glycated hemoglobin [ HbA1c ] , 6.9 % ) , previously treated with metformin and any sulfonylurea to receive either vildagliptin ( 50 mg twice daily ) or gliclazide plus metformin .
METHODS	The study included four office visits ( three pre-Ramadan ) and multiple telephone contacts , as well as Ramadan-focused advice .
METHODS	Hypoglycemic events were assessed during Ramadan ; HbA ( 1c ) and weight were analyzed before and after Ramadan .
RESULTS	The proportion of patients reporting confirmed ( < 3.9 mmol/L and/or severe ) hypoglycemic events during Ramadan was 3.0 % with vildagliptin and 7.0 % with gliclazide ( P = 0.039 ; one-sided test ) , and this was 6.0 % and 8.7 % , respectively , for any hypoglycemic events ( P = 0.173 ) .
RESULTS	The adjusted mean change pre - to post-Ramadan in HbA ( 1c ) was 0.05 % 0.04 % with vildagliptin and -0.03 % 0.04 % with gliclazide , from baselines of 6.84 % and 6.79 % , respectively ( P = 0.165 ) .
RESULTS	In both groups , the adjusted mean decrease in weight was -1.10.2 kg ( P = 0.987 ) .
RESULTS	Overall safety was similar between the treatments .
CONCLUSIONS	In line with the results from previous observational studies , vildagliptin was shown in this interventional study to be an effective , safe , and well-tolerated treatment in patients with T2DM fasting during Ramadan , with a consistently low incidence of hypoglycemia across studies , accompanied by good glycemic and weight control .
CONCLUSIONS	In contrast , gliclazide showed a lower incidence of hypoglycemia in the present interventional than the previous observational studies .
CONCLUSIONS	This is suggested to be linked to the specific circumstances of this study , including frequent patient-physician contacts , Ramadan-focused advice , a recent switch in treatment , and very well-controlled patients , which is different from what is often seen in real life .

###24803302
OBJECTIVE	AMG 181 pharmacokinetics/pharmacodynamics ( PK/PD ) , safety , tolerability and effects after single subcutaneous ( s.c. ) or intravenous ( i.v. ) administration were evaluated in a randomized , double-blind , placebo-controlled study .
METHODS	Healthy male subjects ( n = 68 ) received a single dose of AMG 181 or placebo at 0.7 , 2.1 , 7 , 21 , 70mg s.c. ( or i.v. ) , 210mg s.c. ( or i.v. ) , 420mg i.v. or placebo .
METHODS	Four ulcerative colitis ( UC ) subjects ( n = 4 , male : female 2:2 ) received 210mg AMG 181 or placebo s.c. ( 3:1 ) .
METHODS	AMG 181 concentration , anti-AMG 181-antibody ( ADA ) , 4 7 receptor occupancy ( RO ) , target cell counts , serum C-reactive protein , fecal biomarkers and Mayo score were measured .
METHODS	Subjects were followed 3-9 months after dose .
RESULTS	Following s.c. dosing , AMG 181 was absorbed with a median tmax ranging between 2-10 days and a bioavailability between 82 % and 99 % .
RESULTS	Cmax and AUC increased dose-proportionally and approximately dose-proportionally , respectively , within the 70-210mg s.c. and 70-420mg i.v. ranges .
RESULTS	The linear - phase t1/2 was 31 ( range 20-48 ) days .
RESULTS	Target-mediated disposition occurred at serum AMG 181 concentrations of less than 1gml ( -1 ) .
RESULTS	The PD effect on 4 7 RO showed an EC50 of 0.01 gml ( -1 ) .
RESULTS	Lymphocytes , eosinophils , CD4 + T cells and subset counts were unchanged .
RESULTS	AMG 181-treated UC subjects were in remission with mucosal healing at weeks 6 , 12 and/or 28 .
RESULTS	The placebo-treated UC subject experienced colitis flare at week 6 .
RESULTS	No ADA or AMG 181 treatment-related serious adverse events were observed .
CONCLUSIONS	AMG 181 has PK/PD , safety , and effect profiles suitable for further testing in subjects with inflammatory bowel diseases .

###24326237
BACKGROUND	Behavioral migraine approaches are effective in reducing headache attacks .
BACKGROUND	Availability of treatment might be increased by using migraine patients as trainers .
BACKGROUND	Therefore , Mrelle and colleagues developed and evaluated a home-based behavioral management training ( BMT ) by lay trainers ( 1 ) .
BACKGROUND	The maintenance of effects at long-term follow-up is studied in the present study .
METHODS	Measurements were taken pre-BMT ( T0 ) , post-BMT ( T1 ) , at six-month follow-up ( T2 ) , and at long-term follow-up , i.e. two to four years after BMT ( T3 ) .
METHODS	Data of 127 participants were analyzed with longitudinal multi-level analyses .
RESULTS	Short-term improvements in attack frequency and self-efficacy post-BMT were maintained at long-term follow-up ( DT0T3 = -.34 and DT0T3 = .69 , respectively ) .
RESULTS	The level of internal control that increased during BMT decreased from post-BMT to long-term follow-up ( DT0T3 = .18 ) .
RESULTS	Quality of life and migraine-related disability improved gradually over time ( DT0T3 = .45 and DT0T3 = -.26 , respectively ) .
CONCLUSIONS	Although the results should be interpreted with caution because of the lack of a follow-up control group and the inability to gather information about additional treatments patients may have received during the follow-up period , the findings suggest that lay BMT for migraine may be beneficial over the long term .
CONCLUSIONS	If so , this could make migraine treatments more widely available .

###25244414
OBJECTIVE	: Although numerous animal studies suggest that probiotic therapy has beneficial effects in various liver diseases , the evidence for beneficial effects in human liver disease is controversial .
OBJECTIVE	This study was carried out to investigate the efficacy of probiotic therapy in alleviating small intestinal bacterial overgrowth ( SIBO ) and permeability in chronic liver disease .
METHODS	Fifty-three patients with chronic liver disease were randomized to either probiotic therapy or placebo .
METHODS	Six bacterial species were used : Bifidobacterium bifidum , Bifidobacterium lactis , Bifidobacterium longum , Lactobacillus acidophilus , Lactobacillus rhamnosus , and Streptococcus thermophilus .
METHODS	After 4 weeks , changes in the composition of fecal bacteria , SIBO , intestinal permeability , and clinical symptoms were examined .
RESULTS	Three of the six probiotic species , B. lactis , L. rhamnosus , and L. acidophilus , increased in the feces of the probiotic therapy group ( P < 0.001 ) , whereas there was no change in fecal microbiota in the placebo group .
RESULTS	SIBO disappeared in many individuals of the probiotic therapy group , but none in the placebo ( 24 vs. 0 % , P < 0.05 ) .
RESULTS	General gastrointestinal symptoms also improved more in the probiotic group and improvement in intestinal permeability was slightly but not significantly more frequent in the probiotic arm than the placebo arm ( 50 vs. 31.3 % , P = 0.248 ) .
RESULTS	Numbers of lactobacilli in stool were correlated negatively with intestinal permeability ( P for trend < 0.05 ) .
RESULTS	Liver chemistry did not improve significantly in either group .
CONCLUSIONS	We conclude that short-term probiotic administration in chronic liver disease is effective in alleviating SIBO and clinical symptoms , but ineffective in improving intestinal permeability and liver function .

###25142085
BACKGROUND	Hydration to prevent contrast-induced acute kidney injury ( CI-AKI ) induces a diagnostic delay when performing computed tomography-pulmonary angiography ( CTPA ) in patients suspected of having acute pulmonary embolism .
OBJECTIVE	To analyze whether withholding hydration is non-inferior to sodium bicarbonate hydration before CTPA in patients with chronic kidney disease ( CKD ) .
METHODS	We performed an open-label multicenter randomized trial between 2009 and 2013 .
METHODS	One hundred thirty-nine CKD patients were randomized , of whom 138 were included in the intention-to-treat population : 67 were randomized to withholding hydration and 71 were randomized to 1-h 250mL 1.4 % sodium bicarbonate hydration before CTPA .
METHODS	Primary outcome was the increase in serum creatinine 48-96h after CTPA .
METHODS	Secondary outcomes were the incidence of CI-AKI ( creatinine increase > 25 % / > 0.5 mgdL ( -1 ) ) , recovery of renal function , and the need for dialysis within 2months after CTPA .
METHODS	Withholding hydration was considered non-inferior if the mean relative creatinine increase was 15 % compared with sodium bicarbonate .
RESULTS	Mean relative creatinine increase was -0.14 % ( interquartile range -15.1 % to 12.0 % ) for withholding hydration and -0.32 % ( interquartile range -9.7 % to 10.1 % ) for sodium bicarbonate ( mean difference 0.19 % , 95 % confidence interval -5.88 % to 6.25 % , P-value non-inferiority < 0.001 ) .
RESULTS	CI-AKI occurred in 11 patients ( 8.1 % ) : 6 ( 9.2 % ) were randomized to withholding hydration and 5 ( 7.1 % ) to sodium bicarbonate ( relative risk 1.29 , 95 % confidence interval 0.41-4 .03 ) .
RESULTS	Renal function recovered in 80.0 % of CI-AKI patients within each group ( relative risk 1.00 , 95 % confidence interval 0.54-1 .86 ) .
RESULTS	None of the CI-AKI patients developed a need for dialysis .
CONCLUSIONS	Our results suggest that preventive hydration could be safely withheld in CKD patients undergoing CTPA for suspected acute pulmonary embolism .
CONCLUSIONS	This will facilitate management of these patients and prevents delay in diagnosis as well as unnecessary start of anticoagulant treatment while receiving volume expansion .

###25239625
OBJECTIVE	To evaluate the impact of sending an email to responsible parties of completed trials that do not comply with the Food and Drug Administration Amendments Act 801 legislation , to remind them of the legal requirement to post results .
METHODS	Cohort embedded pragmatic randomized controlled trial .
METHODS	Trials registered on ClinicalTrials.gov .
METHODS	190 out of 379 trials randomly selected by computer generated randomization list to receive the intervention ( personalized emails structured as a survey and sent by one of us to responsible parties of the trials , indirectly reminding them of the legal requirement and potential penalties for non-compliance ) .
METHODS	The primary outcome was the proportion of results posted on ClinicalTrials.gov at three months .
METHODS	The secondary outcome was the proportion posted at six months .
METHODS	In a second step , two assessors blinded to the intervention group collected the date of the first results being received on ClinicalTrials.gov .
METHODS	A post hoc sensitivity analysis excluding trials wrongly included was performed .
RESULTS	Among 379 trials included , 190 were randomized to receive the email intervention .
RESULTS	The rate of posting of results did not differ at three months between trials with or without the intervention : 36/190 ( 19 % ) v 24/189 ( 13 % ) , respectively ( relative risk 1.5 , 95 % confidence interval 0.9 to 2.4 , P = 0.096 ) but did at six months : 46/190 ( 24 % ) v 27/189 ( 14 % ) , 1.7 , 1.1 to 2.6 , P = 0.014 .
RESULTS	In the sensitivity analysis , which excluded 48/379 trials ( 13 % ) , 26/190 ( 14 % ) and 22/189 ( 12 % ) , respectively , results were significant at three months ( relative risk 5.1 , 1.1 to 22.9 , P = 0.02 ) and at six months ( 4.1 , 1.3 to 10.6 , P = 0.001 ) .
CONCLUSIONS	Sending email reminders about the FDA 's legal requirement to post results at ClinicalTrials.gov improved significantly the posting rate at six months but not at three months.Trial registration ClinicalTrials.gov NCT01658254 .

###24307876
BACKGROUND	Restless leg syndrome ( RLS ) is one of the prevalent complaints of patients with end stage renal diseases suffering chronic hemodialysis .
BACKGROUND	Although there are some known pharmacological managements for this syndrome , the adverse effect of drugs causes a limitation for using them .
BACKGROUND	In this randomized clinical trial we aimed to find a nonpharmacological way to improve signs of restless leg syndrome and patients ' quality of life .
METHODS	Twenty-six patients were included in the study and divided into 2 groups of control and exercise .
METHODS	The exercise group used aerobic exercise during their hemodialysis for 16 weeks .
METHODS	The quality of life and severity of restless leg syndrome were assessed at the first week of study and final week .
METHODS	Data were analyzed using SPSS software .
RESULTS	The difference of means of RLS signs at the first week of study and final week was -5.5 4.96 in exercise group and -0.53 2.3 in control group .
RESULTS	There was not any statistical difference between control group and exercise group in quality of life at the first week of study and final week .
CONCLUSIONS	We suggest using aerobic exercise for improving signs of restless leg syndrome , but no evidence was found for its efficacy on patient 's quality of life .

###24820831
OBJECTIVE	Randomized controlled trials in developed countries have reported benefits of Lactobacillus GG ( LGG ) in the treatment of acute watery diarrhoea , but there is paucity of such data from India .
OBJECTIVE	The study was aimed to evaluate the efficacy and safety of Lactobacillus GG in the treatment of acute diarrhoea in children from a semi-urban city in north India .
METHODS	In this open labelled , randomized controlled trial 2000 children with acute watery diarrhoea , aged between 6 months to 5 years visiting outpatient department and emergency room of a teaching hospital in north India were enrolled .
METHODS	The children were randomized into receiving either Lactobacillus GG in dose of 10 billion cfu/day for five days or no probiotic medication in addition to standard WHO management of diarrhoea .
METHODS	Primary outcomes were duration of diarrhoea and time to change in consistency of stools .
RESULTS	Median ( inter quartile range ) duration of diarrhoea was significantly shorter in children in LGG group [ 60 ( 54-72 ) h vs. 78 ( 72-90 ) h ; P < 0.001 ] .
RESULTS	Also , there was faster improvement in stool consistency in children receiving Lactobacillus GG than control group [ 36 ( 30-36 ) h vs. 42 ( 36-48 ) h ; P < 0.001 ] .
RESULTS	There was significant reduction in average number of stools per day in LGG group ( P < 0.001 ) compared to the control group .
RESULTS	These benefits were seen irrespective of rotavirus positivity in stool tests .
CONCLUSIONS	Our results showed that the use of Lactobacillus GG in children with acute diarrhoea resulted in shorter duration and faster improvement in stool consistency as compared to the control group .

###24906450
BACKGROUND	In persons 15 years and above in South Africa the prevalence of pre-diabetes and diabetes has been estimated at 9.1 % and 9.6 % , respectively , and the prevalence of systolic prehypertension and hypertension , 38.2 % and 24.6 % , respectively .
BACKGROUND	Elevated blood glucose and elevated blood pressure are prototype of preventable chronic cardiovascular disease risk factors.Lifestyle interventions have been shown to control high normal blood pressure and/or high normal blood glucose .
METHODS	This study proposes to evaluate the efficacy of a community ( church ) - based lifestyle intervention programme to control high normal blood pressure and/or high normal blood glucose in church members in a randomized controlled trial in Gauteng , South Africa .
METHODS	The objectives are to : ( 1 ) measure non-communicable diseases profile , including hypertension and diabetes , health behaviours , weight management and psychological distress of church members ; ( 2 ) measure the reduction of blood glucose and blood pressure levels after the intervention ; ( 3 ) prevent the development of impaired glucose tolerance ; ( 4 ) compare health behaviours , weight management and psychological distress , blood glucose and blood pressure levels between intervention and control groups , and within group during 6 , 12 , 24 and 36 months during and post intervention .
METHODS	The study will use a group-randomized design , recruiting 300 church members from 12 churches .
METHODS	Churches will be randomly assigned to experimental and control conditions .
CONCLUSIONS	Lifestyle interventions may prevent from the development of high blood pressure and/or diabetes .
CONCLUSIONS	The findings will impact public health and will enable the health ministry to formulate policy related to lifestyle interventions to control blood pressure and glucose .
BACKGROUND	PACTR201105000297151 .

###24838896
OBJECTIVE	The aim of the present study was to analyze the efficacy of Papacarie ( ) gel compared with the traditional method ( low-speed bur ) in reducing the counts of total bacteria , Lactobacillus , total Streptococcus and Streptococcus mutans group .
METHODS	A randomized , controlled clinical trial with a split-mouth design was performed .
METHODS	The sample comprised 40 deciduous teeth in 20 children ( 10 males and 10 females ) aged four to seven years .
METHODS	The teeth were randomly allocated to two groups : G1 , or chemomechanical caries removal with Papacarie Duo ( ) , and G2 , or the removal of carious dentin tissue with a low-speed bur .
METHODS	Infected dentin was collected prior to the procedure , and the remaining dentin was collected immediately following the removal of the carious tissue .
METHODS	Initial and final counts of bacterial colonies were performed to determine whether there was a reduction in the number of colony-forming units ( CFUs ) of each microorganism studied .
METHODS	ClinicalTrials.gov : NCT01811420 .
RESULTS	Reductions were found in the numbers of total bacteria , total Streptococcus and Streptococcus mutans group following either of the caries removal methods ( p < 0.05 ) .
RESULTS	A reduction was also noted in the number of Lactobacillus CFUs ; however , this difference did not achieve statistical significance ( p > 0.05 ) .
CONCLUSIONS	Papacarie ( ) is an excellent option for the minimally invasive removal of carious tissue , achieving significant reductions in total bacteria , total Streptococcus and S. mutans with the same effectiveness as the traditional caries removal method .

###25268516
BACKGROUND	Studies in animals and in vitro and phase 2 studies in humans suggest that statins may be beneficial in the treatment of the acute respiratory distress syndrome ( ARDS ) .
BACKGROUND	This study tested the hypothesis that treatment with simvastatin would improve clinical outcomes in patients with ARDS .
METHODS	In this multicenter , double-blind clinical trial , we randomly assigned ( in a 1:1 ratio ) patients with an onset of ARDS within the previous 48 hours to receive enteral simvastatin at a dose of 80 mg or placebo once daily for a maximum of 28 days .
METHODS	The primary outcome was the number of ventilator-free days to day 28 .
METHODS	Secondary outcomes included the number of days free of nonpulmonary organ failure to day 28 , mortality at 28 days , and safety .
RESULTS	The study recruited 540 patients , with 259 patients assigned to simvastatin and 281 to placebo .
RESULTS	The groups were well matched with respect to demographic and baseline physiological variables .
RESULTS	There was no significant difference between the study groups in the mean ( SD ) number of ventilator-free days ( 12.69.9 with simvastatin and 11.510.4 with placebo , P = 0.21 ) or days free of nonpulmonary organ failure ( 19.411.1 and 17.811.7 , respectively ; P = 0.11 ) or in mortality at 28 days ( 22.0 % and 26.8 % , respectively ; P = 0.23 ) .
RESULTS	There was no significant difference between the two groups in the incidence of serious adverse events related to the study drug .
CONCLUSIONS	Simvastatin therapy , although safe and associated with minimal adverse effects , did not improve clinical outcomes in patients with ARDS .
CONCLUSIONS	( Funded by the U.K. National Institute for Health Research Efficacy and Mechanism Evaluation Programme and others ; HARP-2 Current Controlled Trials number , ISRCTN88244364 . )

###25720929
OBJECTIVE	Despite improvements in endovascular therapy for lower extremity arterial disease , open surgical revascularization is still required when the disease is extensive .
OBJECTIVE	Although autogenous vein is the conduit of choice for open femoropopliteal bypass , prosthetic grafts can be an acceptable alternative when adequate vein is not available .
OBJECTIVE	The FUSION BIOLINE heparin-coated vascular graft ( Maquet Endovascular , Wayne , NJ ) was developed to improve the patency rate associated with standard prosthetic grafts .
OBJECTIVE	The current study , the FINEST Trial ( Comparison of Safety and Primary Patency Between the FUSION BIOLINE Heparin-Coated Vascular Graft and EXXCEL Soft ePTFE ) , was designed to assess the clinical outcome of heparin-coated and standard vascular grafts in a prospective , randomized , controlled , multicenter trial .
METHODS	During a 25-month period ending in June 2012 , 209 eligible patients scheduled to undergo elective prosthetic femoral to above-knee or below-knee popliteal bypass were randomized to receive a standard expanded polytetrafluoroethylene ( ePTFE ) graft or the heparin-coated FUSION BIOLINE vascular graft .
METHODS	Among 203 patients in the efficacy analysis , claudication was the presenting symptom in 147 ( 72.4 % ) , and the site of the distal anastomosis was at the above-knee level in 174 ( 85.7 % ) .
METHODS	Grafts were assessed by duplex ultrasound imaging and ankle-brachial indices performed postoperatively at discharge and at 30 days , 6 months , and 12 months .
METHODS	The primary efficacy end point was primary patency of the study graft .
METHODS	The primary safety end point was the composite of major adverse events and periprocedural death .
METHODS	Secondary end points included the time to hemostasis of bleeding at the anastomotic suture hole and primary assisted and secondary patency .
RESULTS	The primary patency rates at 6 months were 86.4 % for the FUSION BIOLINE heparin-coated vascular graft group compared with 70.0 % for the standard ePTFE group , a difference of 16.4 % ( 95 % confidence interval , 2.7 % -29.9 % ; P = .006 ) , and the respective rates at 12 months were 76.5 % and 67.0 % ( 95 % confidence interval , -4.8 % to 23.0 % ; P = .05 ) .
RESULTS	The mean time to hemostasis of bleeding at the suture hole was 3.5 minutes in the FUSION BIOLINE group and 11.0 minutes in the standard ePTFE group ( P < .0001 ) .
RESULTS	Major adverse events were significantly lower in the FUSION BIOLINE group , occurring in 17.1 % , compared with 30.7 % in the standard ePTFE group ( P = .033 ) , principally a result of a lower rate of major graft reinterventions through 12 months in the FUSION BIOLINE group ( 16.2 % vs 30.7 % ) .
CONCLUSIONS	Data from this randomized multicenter study demonstrated improved midterm patency , less bleeding at the suture hole , and lower major adverse events with the FUSION BIOLINE heparin-coated vascular graft compared with standard ePTFE grafts .
CONCLUSIONS	Although the ultimate long-term benefit of the graft can not be ascertained with the data currently available , the utility of the FUSION BIOLINE vascular graft appears promising .

###25713280
OBJECTIVE	To describe the spectrum of cognitive outcomes of children with and without cerebral palsy ( CP ) after neonatal encephalopathy , evaluate the prognostic value of early developmental testing and report on school services and additional therapies .
METHODS	The participants of this study are the school-aged survivors of the National Institute of Child Health and Human Development Neonatal Research Network randomized controlled trial of whole-body hypothermia .
METHODS	Children underwent neurologic examinations and neurodevelopmental and cognitive testing with the Bayley Scales of Infant Development-II at 18 to 22 months and the Wechsler intelligence scales and the Neuropsychological Assessment-Developmental Neuropsychological Assessment at 6 to 7 years .
METHODS	Parents were interviewed about functional status and receipt of school and support services .
METHODS	We explored predictors of cognitive outcome by using multiple regression models .
RESULTS	Subnormal IQ scores were identified in more than a quarter of the children : 96 % of survivors with CP had an IQ < 70 , 9 % of children without CP had an IQ < 70 , and 31 % had an IQ of 70 to 84 .
RESULTS	Children with a mental developmental index < 70 at 18 months had , on average , an adjusted IQ at 6 to 7 years that was 42 points lower than that of those with a mental developmental index > 84 ( 95 % confidence interval , -49.3 to -35.0 ; P < .001 ) .
RESULTS	Twenty percent of children with normal IQ and 28 % of those with IQ scores of 70 to 84 received special educational support services or were held back 1 grade level .
CONCLUSIONS	Cognitive impairment remains an important concern for all children with neonatal encephalopathy .

###25740027
BACKGROUND	A fiberglass short arm cast can be used to treat a distal radial fracture , but posttraumatic edema may lead to excessive cast tightness and resultant soft-tissue injury .
BACKGROUND	We sought to quantify a simulated edema-induced pressure within a fiberglass short arm cast and to determine the effectiveness of different cast-cutting methods for pressure reduction .
BACKGROUND	We hypothesized that cast cutting could eliminate all clinically relevant pressure and Ace wrap would insignificantly increase pressure .
METHODS	Skin surface pressure under fiberglass short arm casts was measured on ninety wrists from forty-five volunteers randomly assigned to one cast-cutting method : single-cut ( cast bivalve and Ace wrap ) , double-cut ( cast bivalve , spread , and Ace wrap ) , or triple-cut ( cast bivalve , spread , Webril cut , and Ace wrap ) .
METHODS	Each wrist was immobilized in a cast in the neutral position with one roll of 2-inch ( 5.1-cm ) cotton Webril and one roll of 2-inch ( 5.1-cm ) fiberglass .
METHODS	Each fiberglass short arm cast contained an empty intravenous fluid bag in which we infused air .
METHODS	This simulated edema , which generated a skin surface pressure , which was measured by a pressure transducer .
RESULTS	Each cast-cutting method significantly reduced ( p < 0.0001 ) the skin surface pressure from the average maximum of 92.5 mm Hg in a non-fracture setting .
RESULTS	Prior to Ace wrapping , there was a reduction in skin surface pressure of 70.8 % for the single-cut method , 85.1 % for the double-cut method , and 99.9 % for the triple-cut method .
RESULTS	Ace wrap significantly increased skin surface pressure ( p < 0.0001 ) , lessening the effectiveness of cast cutting .
RESULTS	There was an overall reduction in skin surface pressure of 55.9 % for the single-cut method , 64.3 % for the double-cut method , and 77.2 % for the triple-cut method .
RESULTS	Throughout our study , women had significantly higher skin surface pressure than men ( p < 0.0001 ) ; the average maximum was 104.4 mm Hg for women and 81.1 mm Hg for men .
CONCLUSIONS	The single-cut method provides the greatest pressure reduction , but only the triple-cut method eliminated all relevant skin surface pressure .
CONCLUSIONS	Ace wrapping a cut cast noticeably increased skin surface pressure .
CONCLUSIONS	In volunteers without a fracture , only the triple-cut method is effective enough to eliminate clinically relevant skin surface pressure .
CONCLUSIONS	Ace wrap should be applied with caution after the cast is cut .
CONCLUSIONS	The specific effect on pressure reduction in a patient who requires some soft-tissue pressure to maintain fracture reduction was not studied .

###24273971
OBJECTIVE	To observe the efficacy of Danzhi Xiaoyao Pill ( DXP ) in anovulation infertility patients with polycystic ovary syndrome ( PCOS ) of pathogenic fire derived from stagnation of Gan-qi ( PFDSG ) complicated insulin resistance ( IR ) .
METHODS	Sixty PCOS patients were randomly assigned to two group , the integrative medical treatment group ( Group A ) and the Western medical treatment group ( Group B ) , 30 cases in each group .
METHODS	All patients took Metformin and Diane-35 .
METHODS	Those in Group A took DXP additionally .
METHODS	The therapeutic course for all was 3 menstrual cycles .
METHODS	After treatment the ovulation was induced by oral administration of letrozole or injection of menotropins ( HMG ) .
METHODS	The therapeutic efficacy was compared between the two groups .
RESULTS	The levels of insulin , luteinizing hormone , and testosterone were obviously lower after treatment than before treatment in the two groups ( P < 0.05 ) .
RESULTS	There was no statistical difference between the two groups after treatment .
RESULTS	There was no statistical difference in body mass index ( BMI ) between the two groups before and after treatment ( P > 0.05 ) .
RESULTS	Better effects were obtained in Group A in improving symptoms such as agitation and irritability , fullness in the chest and hypochondrium , swollen pain in the breast before menstruation , bitter and dry mouth , oligomenorrhea , abnormal color and amount of menstruation , and pulse and tongue ( P < 0.05 , P < 0.01 ) .
RESULTS	The ovulation rate was 86.1 % ( 93/108 cases ) in Group A , obviously higher than that in Group B ( 65.5 % , 74/113 cases ) .
RESULTS	The clinical pregnancy rate was 60.0 % ( 18/30 cases ) in Group A , obviously higher than that in Group B ( 36.7 % , 11/30 cases ) , showing statistical difference ( P < 0.05 ) .
CONCLUSIONS	DXP could improve the ovulation rate and the pregnancy rate in anovulation infertility patients with PCOS complicated IR .
CONCLUSIONS	It also could significantly improve Chinese medical syndromes , showing obvious advantages over using Western medicine alone .

###24626264
OBJECTIVE	Thoracentesis is one of the bedside procedures most commonly associated with iatrogenic complications , particularly pneumothorax .
OBJECTIVE	Various risk factors for complications associated with thoracentesis have recently been identified , including an inexperienced operator ; an inadequate or inexperienced support team ; the lack of a standardized protocol ; and the lack of ultrasound guidance .
OBJECTIVE	We sought to determine whether ultrasound-guided thoracentesis can reduce the risk of pneumothorax and improve outcomes ( fewer procedures without fluid removal and greater volumes of fluid removed during the procedures ) .
OBJECTIVE	In our comparison of thoracentesis with and without ultrasound guidance , all procedures were performed by a team of expert pulmonologists , using the same standardized protocol in both conditions .
METHODS	A total of 160 participants were randomly allocated to undergo thoracentesis with or without ultrasound guidance ( n = 80 per group ) .
METHODS	The primary outcome was pneumothorax following thoracentesis .
METHODS	Secondary outcomes included the number of procedures without fluid removal and the volume of fluid drained during the procedure .
RESULTS	Pneumothorax occurred in 1 of the 80 patients who underwent ultrasound-guided thoracentesis and in 10 of the 80 patients who underwent thoracentesis without ultrasound guidance , the difference being statistically significant ( p = 0.009 ) .
RESULTS	Fluid was removed in 79 of the 80 procedures performed with ultrasound guidance and in 72 of the 80 procedures performed without it .
RESULTS	The mean volume of fluid drained was larger during the former than during the latter ( 960 500 mL vs. 770 480 mL ) , the difference being statistically significant ( p = 0.03 ) .
CONCLUSIONS	Ultrasound guidance increases the yield of thoracentesis and reduces the risk of post-procedure pneumothorax .
CONCLUSIONS	( Chinese Clinical Trial Registry identifier : ChiCTR-TRC-12002174 [ http://www.chictr.org/en/] ) .

###25619045
OBJECTIVE	To assess the efficacy of intra-articular sodium hyaluronate , administred once weekly for 3 weeks ( 3 injections ) in Moroccan patients with knee osteoarthritis over 6-month period .
METHODS	We prospectively studied the outcome of 75 patients with painful knee osteoarthritis in grade 1 , 2 and 3 on ACR radiological criteria in our rheumatology clinic in Morocco .
METHODS	Group 1 : 45 patients were treated with 3-weekly injections of intra-articular sodium hyaluronate ( 1 % ; 2,2-2 ,7 MDa ) .
METHODS	Group 2 : 30 patients treated with symptomatic slow-acting drugs for osteoarthritis ( SYSADOA ) .
METHODS	The efficacy parameters were Visual Analogue Scale ( VAS ) and Lequesne index .
RESULTS	In group 1 : 35/45 were female , a mean age of patients was 57.2 ( 8.2 ) years , and a mean Body Mass Index ( BMI ) was 28 ( 1.4 ) kg/m2 .
RESULTS	In group 2 : 23/30 were female , a mean age of patients was 58.6 ( 2.8 ) years , and a mean of BMI was 27.8 ( 1.4 ) kg/m2 .
RESULTS	Before treatment in group 1 , the mean of VAS was 6.5 cm ( 1 ) , and of Lequesne index 10.5 ( 2.1 ) .
RESULTS	At 3 and 6 months after the third injection of sodium hyaluronate , there was a significant improvement from baseline of Lequesne index and VAS ( P = 0.001 ) .
RESULTS	In group 2 before treatment , the mean of VAS was 7 cm ( 0,7 ) , and of Lequesne index 8 ( + 1.1 ) , but the improvement from baseline at 3 and 6 months of treatment was lower than group 1 .
CONCLUSIONS	The results of this prospective study , showed the efficacy of 3-weekly injections of sodium hyaluronate in the treatment of knee osteoarthritis in Moroccan patients over a 6-month period .

###24313906
OBJECTIVE	The aim of this study was to evaluate the effects of a standardized exercise program on sports enjoyment and leisure-time spending in adolescents with congenital heart disease and to know what the moderating impact of their baseline health behavior and disease knowledge is .
METHODS	Included were 93 patients , aged 10 to 25 , with surgical repair for tetralogy of Fallot or with a Fontan circulation for single-ventricle physiology , of 5 participating centers of pediatric cardiology in The Netherlands .
METHODS	They were randomly allocated , stratified for age , gender , and type of congenital heart disease to a 12-week period with either : ( 1 ) three times per week standardized exercise training or ( 2 ) care as usual ( randomization ratio 2:1 ) .
METHODS	At baseline and after 12 weeks , participants completed Web-based questionnaires and were interviewed by phone .
METHODS	Primary analyses tested changes from baseline to follow-up in sports enjoyment and leisure-time spending in the exercise group vs. control group .
METHODS	Secondary analyses concerned the moderating influence of baseline health behavior and disease knowledge on changes from baseline to follow-up , and comparison with normative data .
RESULTS	At follow-up , the exercise group reported a decrease in passive leisure-time spending ( watching television and computer usage ) compared with controls .
RESULTS	Exercise training had no effect on sports enjoyment and active leisure-time spending .
RESULTS	Disease knowledge had a moderating effect on improvement in sports enjoyment , whereas health behavior did not .
RESULTS	Compared with normative data , patients obtained similar leisure time scores and lower frequencies as to drinking alcohol and smoking .
CONCLUSIONS	Exercise training decreased passive , but not active , leisure-time spending .
CONCLUSIONS	It did not influence sports enjoyment .

###25827291
OBJECTIVE	A recent randomized trial demonstrated that concurrent chemoradiotherapy ( CCRT ) with weekly cisplatin and gemcitabine , followed by two adjuvant cycles of cisplatin and gemcitabine improved survival for advanced cervical cancer patients .
OBJECTIVE	An Asian Gynecologic Oncology Group ( AGOG ) study was designed to determine whether only adding gemcitabine in the chemoradiation phase without adjuvant chemotherapy could improve survival .
METHODS	Between March 2009 and March 2013 , 74 eligible patients with International Federation of Obstetrics and Gynecology stage III/IVA cervical cancer or stage I/II with positive pelvic/para-aortic nodal metastasis were enrolled .
METHODS	Thirty-seven patients were randomized to arm C ( weekly cisplatin 40mg/m ( 2 ) ) and 37 patients were randomized to arm CG ( weekly cisplatin 40mg/m ( 2 ) and gemcitabine 125mg/m ( 2 ) ) , for six cycles .
METHODS	Six eligible patients were excluded before the beginning of treatment .
RESULTS	An interim analysis showed superimposable progression-free ( PFS ) and overall survival ( OS ) , a decision of closing accrual was made .
RESULTS	A 3-year PFS was similar in both arms ( arm C 65.1 % vs. arm CG 71.0 % , p = 0.71 ) , and a 3-year OS was 74.1 % in arm C vs. 85.9 % in arm CG ( p = 0.89 ) , but crossed over at 5years .
RESULTS	Grade 2-4 hematological toxicities , including neutropenia ( p = 0.028 ) and thrombocytopenia ( p = 0.001 ) , were more frequent in arm CG than arm C.
CONCLUSIONS	Despite limitation in power , it suggests that only adding gemcitabine at the CCRT phase does not provide substantially superior results , but treatment toxicities could increase .
CONCLUSIONS	Further studies are required to determine the role of post-CCRT adjuvant chemotherapy in advanced cervical cancer .

###24908550
BACKGROUND	Coformulated elvitegravir , cobicistat , emtricitabine , and tenofovir disoproxil fumarate ( tenofovir ) might be a safe and efficacious switch option for virologically suppressed patients with HIV who have neuropsychiatric side-effects on a non-nucleoside reverse transcriptase inhibitor ( NNRTI ) or who are on a multitablet NNRTI-containing regimen and want a regimen simplification .
BACKGROUND	We assessed the non-inferiority of such a switch compared with continuation of an NNRTI-containing regimen .
METHODS	STRATEGY-NNRTI is a 96 week , international , multicentre , randomised , open-label , phase 3b , non-inferiority trial enrolling adults ( 18 years ) with HIV-1 and plasma HIV RNA viral load below 50 copies per mL for at least 6 months on an NNRTI plus emtricitabine and tenofovir regimen .
METHODS	With a computer-generated randomisation sequence , we randomly allocated participants ( 2:1 ; blocks of six , stratified by efavirenz use at screening ) to switch to coformulated elvitegravir , cobicistat , emtricitabine , and tenofovir ( switch group ) or continue the NNRTI plus emtricitabine and tenofovir regimen ( no-switch group ) .
METHODS	Key eligibility criteria included no history of virological failure and an estimated glomerular filtration rate of 70 mL per min or greater .
METHODS	The primary endpoint was the proportion of participants with plasma viral loads below 50 copies per mL at week 48 based on a snapshot algorithm with a non-inferiority margin of 12 % ( assessed by modified intention to treat ) .
METHODS	This trial is ongoing and is registered at ClinicalTrials.gov , number NCT01495702 .
RESULTS	Between Dec 29 , 2011 , and Dec 13 , 2012 , we randomly allocated 439 participants to treatment : 290 participants in the switch group and 143 participants in the no-switch group received treatment and were included in the modified intention-to-treat population .
RESULTS	At week 48 , 271 ( 93 % ) of 290 participants in the switch group and 126 ( 88 % ) of 143 participants in the no-switch group maintained plasma viral loads below 50 copies per mL ( difference 53 % , 95 % CI -05 to 120 ; p = 0066 ) .
RESULTS	We detected no treatment-emergent resistance in either group .
RESULTS	Safety events leading to discontinuation were uncommon in both groups : six ( 2 % ) of 291 participants in the switch group and one ( 1 % ) of 143 in the no-switch group .
CONCLUSIONS	Coformulated elvitegravir , cobicistat , emtricitabine , and tenofovir seems to be efficacious and well tolerated in virologically suppressed adults with HIV and might be a suitable alternative for patients on an NNRTI with emtricitabine and tenofovir regimen considering a regimen modification or simplification .
BACKGROUND	Gilead Sciences .

###25509262
OBJECTIVE	To observe the effect of xuebijing Injection ( XI ) on perioperative coagulation and inflammatory reaction in senile patients receiving total hip arthroplasty ( THA ) .
METHODS	Totally eighty patients receiving THA at Luoyang Orthopedics Hospital , 65 to 85 years old , were randomly assigned to the control group ( 40 cases ) and the treatment group ( 40 cases ) .
METHODS	All patients received routine perioperative therapies .
METHODS	Those in the treatment group received XI ( adding 50 mL XI in 100 mL normal saline , 30 min each time ) .
METHODS	XI was continually injected after THA , twice daily for 3 successive days .
METHODS	Blood samples were harvested on the morning of the 2nd admission day ( TO ) , immediately after operation ( T1 ) , on the morning of the 3rd day after operation ( T3 ) , and on the morning of the 5th day after operation ( T4 ) to detect prothrombin time ( PT ) , thrombin time ( TT ) , activated partial thromboplastin time ( APTT ) , levels of FIB and D-dimer ( D-D ) , changes of white blood cell ( WBC ) , neutrophils ( N ) , C-reactive protein ( CRP ) , erythrocyte sedimentation rate ( ESR ) , and IL-6 .
METHODS	Complications of surgery were compared between the two groups .
RESULTS	There was no statistical difference in operation time , intraoperative blood loss , and blood transfusion between the two groups ( P > 0.05 ) .
RESULTS	Compared with TO in the same group , WBC , N , CRP , ESR , IL-6 , PT , TT , and D-D all increased in the control group at T1-T4 ( P < 0.05 ) ; APTT increased at T1-T2 ( P < 0.05 ) ; FIB increased at T1-T3 ( P < 0.05 ) .
RESULTS	WBC , N , IL-6 , PT , and D-D all increased in the treatment group at T1-T3 ( P < 0.05 ) ; CRP and ESR increased at T1-T4 ( P < 0.05 ) ; TT increased at T1-T2 ( P < 0.05 ) ; APTT and FIB increased at T1 ( P < 0.05 ) .
RESULTS	Compared with the control group at the same time period , WBC , N , CRP , and IL-6 all decreased in the treatment group at T1-T4 ( P < 0.05 ) , ESR decreased at T3-T4 ( P < 0.05 ) ; PT and TT decreased at T1-T3 ( P < 0.05 ) ; FIB and D-D decreased at T2-T4 ( P < 0.05 ) .
RESULTS	The occurrence of each complication was significantly lower in the treatment groups than in the control group .
CONCLUSIONS	XI could improve the perioperative high coagulation state of senile THA patients , inhibit inflammatory reactions , and reduce complications .

###25616822
OBJECTIVE	The purpose of this study was to evaluate the 5-year follow-up ( FU ) data of the THUNDER ( Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries ) .
BACKGROUND	The THUNDER trial was the first study to investigate the treatment of femoropopliteal arteries with a paclitaxel-coated balloon ( PCB ) .
METHODS	In 154 patients , femoropopliteal arteries were treated with PCB , with angioplasty with paclitaxel in contrast medium , or no paclitaxel ( control ) .
METHODS	The primary endpoint was 6-month late lumen loss ( LLL ) .
METHODS	Secondary endpoints included freedom from target lesion revascularization ( TLR ) , binary restenosis rate , and amputation .
METHODS	The 5-year FU compares outcomes in patients treated with PCB and control subjects .
METHODS	Additionally , LLL at 6 months and TLR up to 5-year FU were analyzed in terms of sex and lesion length .
RESULTS	Over the 5-year period , the cumulative number of patients with TLR remained significantly lower in the PCB group ( 21 % ) than in the control group ( 56 % , p = 0.0005 ) .
RESULTS	In the small group of patients with angiographic and duplex sonographic follow-up , PCB was associated with a lower rate of binary restenosis ( 17 % vs. 54 % ; p = 0.04 ) .
RESULTS	No signs of aneurysm formation or constrictive fibrosis were detected .
RESULTS	Whereas LLL at 6-month FU did not differ between men and women in the PCB group , the TLR rate was lower in men than in women at 5-year FU .
RESULTS	A benefit of PCB treatment in terms of LLL and TLR was seen independent of lesion length .
CONCLUSIONS	The reduced TLR rate following PCB treatment was maintained over the 5-year FU period .
CONCLUSIONS	No signs of drug-related local vessel abnormalities were detected .
CONCLUSIONS	( Thunder Trial-Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries [ THUNDER ] ; NCT00156624 ) .

###24620447
OBJECTIVE	Evaluate efficacy/safety of olmesartan medoxomil ( OM ) / amlodipine ( AML ) / hydrochlorothiazide ( HCTZ ) in Hispanic/Latino adults with hypertension .
METHODS	Randomized , double-blind , 12-week , parallel-group study followed by a 40-week open-label extension phase .
METHODS	Clinical sites ( 317 ) in the United States and Puerto Rico .
METHODS	Individuals > or = 18 years of age with mean seated blood pressure ( BP ) > or = 140/100 or > or = 160/90 mm Hg divided into Hispanic/Latino ( 369 ) and non-Hispanic/Latino ( 2122 ) subgroups .
METHODS	Participants were randomized to OM 40/AML 10 mg , OM 40/HCTZ 25 mg , AML 10/HCTZ 25 mg , or OM 40/AML 10/HCTZ 25 mg during the double-blind phase .
METHODS	During the open-label extension , all participants received OM 40/AML 5/HCTZ 12.5 mg ; participants not reaching BP goal within 2 weeks were randomly titrated to OM 40/AML 10/HCTZ 12.5 mg or OM 40/AML 5/HCTZ 25 mg , then to OM 40/AML 10 / HCTZ 25 mg after another 2 weeks .
METHODS	Change in mean seated diastolic BP ( SeDBP ) from baseline ( double-blind phase ) .
RESULTS	Triple-drug therapy vs the dual therapies resulted in greater mean reduction in SeBP ( Hispanic/Latino : 35.0 / 20.9 mm Hg vs 27.8-30 .9 / 15.3-17 .7 mm Hg ; non-Hispanic/Latino : 39.0 / 21.7 mm Hg vs 28.9-31 .5 / 14.6-17 .8 mm Hg ) and enabled more participants to reach BP goal ( Hispanic/Latino : 56.8 % vs 40.6 % -51.2 % ; non-Hispanic/Latino : 65.7 % vs 33.8 % -46.6 % ) irrespective of ethnicity .
RESULTS	The efficacy of triple-drug therapy in achieving BP goal was sustained long-term ( 40-week open-label extension period ) in Hispanic/Latino ( 63.3 % ) and non-Hispanic / Latino ( 64.2 % ) participants .
RESULTS	Triple-drug therapy was well tolerated in Hispanic/Latino and non-Hispanic/Latino participants .
CONCLUSIONS	In this study , OM/AML/HCTZ was an effective treatment option in Hispanic / Latino patients with hypertension .

###24279305
BACKGROUND	Schizophrenia is understood to be a heterogeneous brain condition with overlapping symptom dimensions .
BACKGROUND	The negative symptom dimension , with its protean cognitive manifestations , responds poorly to treatment , which can be a particular challenge in countries where clozapine therapy is not available .
BACKGROUND	Preliminary data indicate that minocycline may be beneficial adjunct in the treatment of schizophrenia : positive , negative , and cognitive symptoms.In this study we aim to assess the efficacy of adjunctive minocycline to alleviate symptoms of schizophrenia in patients who have failed to respond to a therapeutic trial of antipsychotic medications .
METHODS	The study is a parallel group , double-blind , randomized , placebo-controlled trial .
METHODS	Participants will be adults ( aged 18 years and above ) with first episode or relapse episode of schizophrenia of under 5 years ' duration .
METHODS	Patients who failed to show adequate therapeutic response to at least one antipsychotic medication given for a minimum of 4 weeks will be recruited from a psychiatry hospital in Addis Ababa and a psychiatry clinic in Butajira , Ethiopia .
METHODS	A total of 150 participants ( 75 in each arm ) will be required to detect a five-point mean difference between the intervention arms adjusting for baseline symptom severity , at 90 % power and 95 % confidence .
METHODS	Patients in the intervention arm will receive minocycline ( 200 mg/day orally ) added on to the regular antipsychotic medications participants are already on .
METHODS	Those in the placebo arm will receive an inactive compound identical in physical appearance to minocycline .
METHODS	Intervention will be offered for 12 weeks .
METHODS	Diagnosis will be established using the operational criteria for research ( OPCRIT ) .
METHODS	Primary outcome measure will be a change in symptom severity measured using the positive and the negative syndrome scale for schizophrenia ( PANSS ) .
METHODS	Secondary outcome measures will include changes in severity of negative symptoms , proportion achieving remission , and level of functioning .
METHODS	Whether changes are maintained post intervention will also be measured ( PANSS ) .
METHODS	Key assessment for the primary outcome will be conducted at the end of trial ( week 12 ) .
METHODS	One post-intervention assessment will be conducted 4 weeks after the end of intervention ( week 16 ) to determine sustainability of change .
BACKGROUND	Clinicaltrials.gov identifier : NCT01809158 .

###24994700
OBJECTIVE	Owing to the great absorption capability of the pleura for transudates , the protein content of draining pleural fluid may be considered as a more adequate determinant than its daily draining amount in the decision-making for earlier chest tube removal .
OBJECTIVE	In an a priori pilot study , we observed that the initially draining protein-rich exudate converts to a transudate quickly in most patients after lobectomies .
OBJECTIVE	Thus , chest tubes draining high-volume but low-protein fluids can safely be removed earlier in the absence of an air leak .
OBJECTIVE	This randomized study aims to investigate the validity and clinical applicability of this hypothesis as well as its influence on the timing for chest tube removal and earlier discharge after lobectomy .
METHODS	Seventy-two consecutive patients undergoing straightforward lobectomy were randomized into two groups .
METHODS	Patients with conditions affecting postoperative drainage and with persisting air leaks beyond the third postoperative day were excluded .
METHODS	Drains were removed if the pleural fluid to blood protein ratio ( PrRPl/B ) was 0.5 , regardless of its daily draining amount in the study arm ( Group S ; n = 38 ) , and patients in the control arm ( Group C ; n = 34 ) had their tubes removed if daily drainage was 250 ml regardless of its protein content .
METHODS	Patients were discharged home immediately or the following morning after removal of the last drain .
METHODS	All cases were followed up regarding the development of symptomatic pleural effusions and hospital readmissions for a redrainage procedure .
RESULTS	Demographic and clinical characteristics as well as the pattern of decrease in PrRPl/B were the same between groups .
RESULTS	The mean PrRPl/B was 0.65 and 0.67 ( 95 % CI = 0.60-0 .69 and 0.62-0 .72 ) on the first postoperative day , and it remarkably dropped down to 0.39 and 0.33 ( 95 % CI = 0.33-0 .45 and 0.27-0 .39 ) on the second day in Groups S and C , respectively , and remained below 0.5 on the third day ( repeated-measures of ANOVA design , post hoc ` within-group ' comparison of the first postoperative day versus second and third days ; P < 0.002 ) .
RESULTS	Eleven of 38 ( 29 % ) and 16 of 27 ( 59 % ) patients ' chest tubes were , respectively , removed on the first and second postoperative days in Group S , but only two of 34 ( 6 % ) and ten of 32 ( 31 % ) patients , respectively , had their chest tubes removed in Group C ( two-tailed Fisher 's exact test , P = 0.02 and 0.005 for the first and the second postoperative days , respectively ) .
RESULTS	On the third postoperative day , daily drainage remained 250 ml in 22 ( 65 % ) patients , among whom , 17 ( 77 % ) would have their chest tubes removed on the PrRPl/B value in Group C. However , drains could not be removed due to the high protein content of draining fluid despite the acceptable volume of daily drainage in only three ( 27 % ) of 11 cases in Group S ( McNemar 's paired proportions test , P = 0.009 ) .
RESULTS	The mean chest tube removal time ( 2.1 0.9 vs 2.9 1.0 days ; P < 0.001 ) and the median hospital stay [ 3 days ( IQR : 1-3 ) vs 4 days ( IQR : 2-4 ) , P < 0.003 ] were significantly shorter in Group S. None of the patients required a redrainage procedure due to a persistent and symptomatic pleural effusion .
CONCLUSIONS	Regardless of the daily drainage , chest tubes can safely be removed earlier than anticipated in most patients after lobectomy if the protein content of the draining fluid is low .

###25455432
OBJECTIVE	Phosphodiesterase type-5 inhibitors ( PDE5Is ) are first-line therapies for erectile dysfunction ( ED ) .
OBJECTIVE	Sildenafil ( SIL ) and vardenafil ( VAR ) are approved for as-needed ( PRN ) dosing ; tadalafil ( TAD ) is approved for both PRN and once-a-day ( OaD ) dosing for ED .
OBJECTIVE	Recent evidence suggests that TAD-OaD may be effective as therapy in men with an incomplete response to PRN-PDE5I therapy .
OBJECTIVE	This study evaluated whether TAD-OaD provides similar efficacy in men with ED who had previously demonstrated a partial response to PRN-PDE5I therapy .
METHODS	In this randomized , double-blind , placebo-controlled trial , men with a 3 month ED history received SIL 100mg , TAD 20mg , or VAR 20mg during a 4 week open-label lead-in period .
METHODS	Those with International Index of Erectile Function - Erectile Function ( IIEF-EF ) domain scores < 26 following lead-in treatment completed a 4 week washout period , then randomized to TAD 2.5 mg up-titrated to 5mg , TAD 5mg , or placebo ( PBO ) OaD for 12 weeks .
METHODS	MAIN OUTCOME MEASURES obtained from patients treated with TAD-OaD were compared to PBO-treated patients .
METHODS	Additionally , results of treatment with TAD-OaD were compared to results obtained from 4 week PRN-PDE5I therapy to determine whether OaD and PRN regimens provided comparable efficacy .
BACKGROUND	NCT01130532 .
METHODS	International Index of Erectile Function ( IIEF ) domain scores ; Sexual Encounter Profile ( SEP ) questions 2-5 .
RESULTS	Endpoint data was obtained from 590 men ( 391 TAD ; 199 PBO ) .
RESULTS	RESULTS for all IIEF and SEP measures were significantly better for TAD-OaD ( p < 0.001 for all ) compared to PBO and were comparable to those observed during PRN-PDE5I treatment .
RESULTS	TAD 2.5 mg and TAD 5mg OaD therapy were safe and generally well tolerated .
CONCLUSIONS	Tadalafil once daily is a viable alternative to as-needed PDE5I therapy in men with ED .
CONCLUSIONS	Key limitations include the lack of a PRN PDE5I study group during the double-blind period , and that many more patients took tadalafil than sildenafil or vardenafil during the PRN period .

###24246768
OBJECTIVE	Hepatic encephalopathy ( HE ) is associated with a poor prognosis in patients with advanced liver disease .
OBJECTIVE	Probiotics alter the intestinal microbiota with non-urease-producing organisms that reduce production of ammonia .
OBJECTIVE	We investigated the efficacy of probiotics for the primary prophylaxis of HE .
METHODS	We conducted a prospective trial at a tertiary care referral institute in New Delhi , India , from January 2012 through March 2013 , of patients with cirrhosis without overt HE ( age , 48.6 11.1 y ; 96 men and 64 women ) ; 25 were Child-Turcotte-Pugh ( CTP ) class A , 51 were CTP class B , and 84 were CTP class C. Subjects were assigned randomly to groups given probiotics ( 1 10 ( 8 ) colony-forming units , 3 times daily ; n = 86 , 42 with minimal HE ) or no test article ( control , n = 74 ; 33 with minimal HE ) .
METHODS	All subjects underwent psychometric analyses , critical flicker fusion ( CFF ) threshold assessments , glucose hydrogen breath tests to identify small intestinal bacterial overgrowth ( SIBO ) , and lactulose hydrogen breath tests to measure orocecal transit time ( OCTT ) .
METHODS	The primary end point was the development of overt HE .
RESULTS	At baseline , subjects in each group had comparable CTP score , model for end-stage liver disease scores , CFF assessments , psychometric hepatic encephalopathy scores , and OCTT .
RESULTS	After a mean follow-up period of 38.6 8.80 weeks for patients given probiotics and 40.3 9.8 weeks for controls , 6 patients given probiotics and 7 controls died ( P = .81 ) .
RESULTS	Three months of probiotic administration significantly reduced levels of arterial ammonia , SIBO , and OCTT ; increased psychometric hepatic encephalopathy scores ; and increased CFF thresholds , compared with baseline .
RESULTS	Seven subjects in the probiotic group and 14 controls developed overt HE ( P < .05 ; hazard ratio for controls vs probiotic group , 2.1 ; 95 % confidence interval , 1.31-6 .53 ) .
RESULTS	Psychometric hepatic encephalopathy scores , CTP scores , and SIBO correlated with the development of overt HE .
CONCLUSIONS	In a prospective , randomized controlled trial , probiotics were found to be effective in preventing HE in patients with cirrhosis .
CONCLUSIONS	Trial registration No : CTRI/2012/07 / 002807 .

###25526875
OBJECTIVE	We sought to compare weight loss in the first 6 weeks postpartum among women with gestational diabetes mellitus ( GDM ) treated with metformin or placebo , a promising therapy to reduce later risk of progression to diabetes mellitus .
METHODS	We conducted a pilot , randomized trial of metformin vs placebo in postpartum women with GDM .
METHODS	Women with pre-GDM , unable to tolerate metformin , resumed on insulin or oral hypoglycemic agent , delivered < 34 weeks ' gestation , or with a body mass index < 20 kg/m ( 2 ) were excluded .
METHODS	Women were randomized to either metformin 850 mg daily for 7 days , then metformin 850 mg twice a day for the next 5 weeks or placebo prescribed in a similar frequency .
METHODS	The subject , health care provider , and research staff were blinded to the treatment .
METHODS	The primary outcome was weight change from delivery to 6 weeks postpartum .
METHODS	Secondary outcomes included the percentage of women achieving their self-reported prepregnancy weight , reported medication adherence , adverse effects , and satisfaction .
METHODS	Differences in weight change between groups were determined by Wilcoxon rank sum test and in achieving prepregnancy weight by ( 2 ) test .
RESULTS	Of 114 women randomized , 79 ( 69.3 % ) completed the 6 weeks ; 36 ( 45.6 % ) were randomized to metformin and 43 ( 54.4 % ) to placebo .
RESULTS	Metformin and placebo groups were similar in median weight loss ( 6.3 kg [ range , -0.3 to 19.8 ] vs 6.5 kg [ range , -0.3 to 12.1 ] , P = .988 ) and percentage of women achieving reported prepregnancy weight ( 41.7 vs 37.2 % , P = .69 ) .
RESULTS	Self-reported adherence in taking > 50 % of medication was 75 % at 3 weeks and 97 % at 6 weeks .
RESULTS	Nausea , diarrhea , and hypoglycemia were reported in approximately 11-17 % of women and 56-63 % reported dissatisfaction with the medication .
CONCLUSIONS	Women with GDM lost approximately 6 kg by 6 weeks ' postpartum .
CONCLUSIONS	This was similar in both groups and resulted in < 50 % of women achieving their prepregnancy weight .
CONCLUSIONS	Although the reported adherence and satisfaction with the medication was high , adverse effects were reported with nearly 1 in 5 women including nausea , diarrhea , and hypoglycemia .
CONCLUSIONS	Contrary to expectation , we found no evidence of benefit from metformin .
CONCLUSIONS	However , longer treatment periods and larger studies with minimal attrition may be warranted .

###25202858
BACKGROUND	Prophylactic use of fresh frozen plasma ( FFP ) in critically ill patients with a coagulopathy is common .
BACKGROUND	However , a lack of evidence of efficacy has resulted in a call for trials on the benefit of FFP in these patients .
BACKGROUND	To date , conducting a trial on this subject has not been successful .
BACKGROUND	Recently , a multi-center randomised trial was stopped prematurely due to slow inclusion .
OBJECTIVE	To assess clinicians ' opinions regarding a trial on prophylactic administration of FFP in coagulopathic critically ill patients who need to undergo an intervention .
METHODS	A survey among 55 intensivists who all participated in a randomised trial on the risks and benefits of FFP in critically ill patients .
RESULTS	Response rate was 84 % .
RESULTS	Majority of respondents indicated that international normalised ratio ( INR ) should be assessed before insertion of a central venous catheter ( CVC ) ( 61 % ) , chest tube ( 89 % ) or tracheostomy ( 91 % ) .
RESULTS	Reasons to withhold transfusion of FFP to non-bleeding critically ill patients are risk of transfusion-related acute lung injury ( TRALI ) ( 46 % ) , fluid overload ( 39 % ) and allergic reaction ( 24 % ) .
RESULTS	Although , the majority of respondents expressed the opinion that the trial was clinically relevant , 56 % indicated that 1 patient subgroups should have been excluded from participation .
CONCLUSIONS	Intensivists express the need for more evidence on the prophylactic use of FFP in coagulopathic critically ill patients .
CONCLUSIONS	However , lack of knowledge about FFP and personal beliefs about the preferable transfusion strategy among clinicians , resulted in premature termination of a clinical trial on this topic .

###24449229
OBJECTIVE	The rate of adherence to regular colonoscopy screening in individuals at increased familial risk of colorectal cancer ( CRC ) is suboptimal , especially among rural and other geographically underserved populations .
OBJECTIVE	Remote interventions may overcome geographic and system-level barriers .
OBJECTIVE	We compared the efficacy of a telehealth-based personalized risk assessment and communication intervention with a mailed educational brochure for improving colonoscopy screening among at-risk relatives of patients with CRC .
METHODS	Eligible individuals age 30 to 74 years who were not up-to-date with risk-appropriate screening and were not candidates for genetic testing were recruited after contacting patients with CRC or their next of kin in five states .
METHODS	Enrollees were randomly assigned as family units to either an active , personalized intervention that incorporated evidence-based risk communication and behavior change techniques , or a mailed educational brochure .
METHODS	The primary outcome was medically verified colonoscopy within 9 months of the intervention .
RESULTS	Of the 481 eligible and randomly assigned at-risk relatives , 79.8 % completed the outcome assessments within 9 months ; 35.4 % of those in the personalized intervention group and 15.7 % of those in the comparison group obtained a colonoscopy .
RESULTS	In an intent-to-treat analysis , the telehealth group was almost three times as likely to get screened as the low-intensity comparison group ( odds ratio , 2.83 ; 95 % CI , 1.87 to 4.28 ; P < .001 ) .
RESULTS	Persons residing in rural areas and those with lower incomes benefitted at the same level as did urban residents .
CONCLUSIONS	Remote personalized interventions that consider family history and incorporate evidence-based risk communication and behavior change strategies may promote risk-appropriate screening in close relatives of patients with CRC .

###25014766
BACKGROUND	In the ongoing GEnotipo , Fenotipo y Ambiente de la HiperTensin Arterial en UruguaY ( GEFA-HT-UY ) study , we applied standardized epidemiological methods to determine complex phenotypes including blood pressure ( BP ) .
BACKGROUND	In this report , we present the quality control of the conventionally measured BP .
METHODS	Three trained observers measured BP five times consecutively in the seated position at each of two home visits and one clinic visit according to the guidelines of the European Society of Hypertension .
METHODS	On 1 December 2013 , 4379 single BP readings in 170 participants were available for analysis .
RESULTS	Fewer BP readings than the five planned per contact occurred only at one home visit .
RESULTS	Among observers , the frequency of identical consecutive readings for systolic or diastolic BP varied from 0 to 4.2 % .
RESULTS	The occurrence of odd readings ranged from 0.1 to 0.6 % .
RESULTS	Only 21.6 % of the systolic and diastolic BP readings ended on zero ( expected 20 % ) .
RESULTS	At home visits , there was a progressive decline in BP from the first to the fifth reading .
RESULTS	The average of the five BP readings also decreased from the first to the second home visit ( -5.63 / -2.34 mmHg ) .
CONCLUSIONS	Our study highlighted the necessity to implement a stringent quality control of the conventionally measured BP .
CONCLUSIONS	The procedures set up in the GEFA-HT-UY study are resulting in a well-defined BP phenotype , which is consistent with that in other population studies .

###24411976
OBJECTIVE	The purpose of this study was to determine whether 400 g/kg oral ivermectin is able to kill Ixodes scapularis nymphs and adult female ticks feeding on humans .
METHODS	Ten study subjects each wore 2 ostomy bags , the one containing 24 I scapularis nymphs , and the other containing 24 I scapularis adult females .
METHODS	Twenty-four hours after the ostomy bags were attached , study subjects received either 400 g/kg ivermectin or placebo .
METHODS	Thirty hours after the ivermectin or placebo was consumed , the ticks were removed , and mortality determined in a double-blinded manner .
RESULTS	Eleven percent of the I scapularis nymphs attached in the ivermectin group compared with 17 % in the placebo .
RESULTS	Mortality for the I scapularis nymphs that attached at the time of removal was 55 % in the ivermectin group and 47 % in the placebo group .
RESULTS	Mortality for the I scapularis nymphs 5 days after removal was 92 % in the ivermectin group and 88 % for the placebo .
RESULTS	Three percent of the I scapularis adults attached in the ivermectin group compared with 9 % in the placebo group .
RESULTS	Mortality for I scapularis adults was 0 % on day 3 and 33 % on day 8 for both the ivermectin and placebo groups .
RESULTS	There were statistically insignificant differences in the mortality rates between I scapularis nymphs and adults exposed to ivermectin or placebo .
CONCLUSIONS	There were a high number of ticks that died in both groups but the data do not support our hypothesis that ivermectin can kill I scapularis .
CONCLUSIONS	The study was not designed to determine whether it could prevent the transmission of tick-borne illness .

###24926629
BACKGROUND	The goal was to investigate the effects of Brain Wave Vibration ( BWV ) , a meditation practised in a class involving rhythmic movements of the head , neck and body practised with related yoga-style exercises , and to isolate the rhythmic effects .
METHODS	A randomised controlled trial was conducted with assessments pre - and post-trial and immediately before and after each session .
METHODS	Thirty-one healthy adults were assessed for mood , sleep , mindfulness , health and well-being , and pre - and post-class activation-deactivation .
METHODS	Participants were randomly assigned to either BWV in toto or a control group having similar yoga exercises without the rhythmic components .
METHODS	Participants completed eight to twelve 75-min classes of BWV or control training over 8-12 weeks .
METHODS	To control for expectation participants were told only that the aim was to compare two subtly different styles of Korean yoga .
RESULTS	The BWV group had comparatively greater improvements in sleep duration and efficiency , although they had higher baseline inefficiency , and post-trial they had better global sleep and well-being and fewer illness symptoms , and better tiredness and energy post-class .
RESULTS	Both groups benefitted in mood , mindfulness and vitality post-trial with improved tension and calmness post-class .
CONCLUSIONS	The participants of both interventions had better mood and well-being on the whole following the trial and were more relaxed immediately after a class .
CONCLUSIONS	However , BWV training was unique in its benefits to sleep , health , well-being , energy and tiredness , warranting further research .

###24706353
OBJECTIVE	To assess the efficacy of a hypotensive prophylactic medication in preventing intraocular pressure ( IOP ) changes after intravitreal injections , and the effect of occurrence of vitreous reflux on the variation of IOP .
METHODS	A total of 141 intravitreal injections of anti-vascular endothelial growth factor drugs ( 0.05 mL ) were randomly distributed into 2 groups : in group 1 ( n = 77 ) , no prophylactic IOP-lowering medication was used ; in group 2 ( n = 64 ) , a fixed combination of brimonidine and timolol was instilled 5 minutes before the injection .
METHODS	The IOP was measured before and 1 , 15 , and 30 minutes after the injection .
METHODS	The presence of vitreous reflux was recorded .
RESULTS	Despite significantly reducing the IOP by ~ 3 mm Hg , prophylactic medication did not prevent a transient IOP rise .
RESULTS	A total of 22.7 % of injections showed vitreous reflux , and those patients experienced much lower initial spikes .
RESULTS	Indeed , only 6.5 % out of 77 injections above 30 mm Hg within 1 minute after injection showed vitreous reflux .
RESULTS	Only one case showed an IOP > 30 mm Hg at 15 minutes , and none at 30 minutes postinjection .
RESULTS	The IOP normalization rates over time were similar in all groups within 15 minutes .
CONCLUSIONS	Prophylactic medication instilled 5 minutes before the injection was not effective in preventing a pressure rise after intravitreal injections .
CONCLUSIONS	Vitreous reflux decreased significantly the spike figures compared to injections with no reflux .

###25233662
OBJECTIVE	To explore the anesthetic effect of preemptive analgesia of frequency acupoint electrical stimulation on painless-induced abortion as well as its effect on anesthetics dosage .
METHODS	Ninety cases of early pregnancy who selected painless-induced abortion were randomly divided into two groups , 45 cases in each group .
METHODS	Frequency acupoint electrical stimulation at Ciliao ( BL 32 ) and Shenshu ( BL 23 ) , disperse-densewave , 2 Hz/100 Hz in frequency for 15 to 20 min , was applied in the group A , which was followed by intravenous anesthesia of propofol .
METHODS	The intravenous anesthesia of propofol was applied in the group B.
METHODS	The blood pressure ( BP ) , heart rate ( HR ) and SpO2 before , during and after surgery , anesthetic effect and dosage , waking time and adverse events were observed in the two groups .
RESULTS	The BP and HR during and after the surgery in the group A were not statistically different from those before the surgery ( all P > 0.05 ) .
RESULTS	The BP was reduced and HR was slowed down during the surgery in the group B , which was significantly different from those before the surgery as well as those in the group A ( all P < 0.05 ) .
RESULTS	The dosage of propofol was ( 114.3 - +6.1 ) mg in the group A. obviously less than ( 193.2 + / - 8.9 ) mg in the group B ( P < 0.05 ) .
RESULTS	The waking time was ( 5.6 + / - 1.2 ) min in the group A , obviously less than ( 10.1 + / - 3.9 ) min in the group B ( P < 0.05 ) .
RESULTS	As for anesthetic effect , the incidence of Grade I in the group A was more than the group B ( P < 0.05 ) .
RESULTS	The adverse events , including nausea , vomiting and contractions pain in the group A were evidently less than those in the group B ( all P < 0.05 ) .
CONCLUSIONS	The preemptive analgesia of frequency acupoint electrical stimulation could significantly improve anesthetic effect of painless-induced abortion , reduce dosage of anesthetics , shorten waking time of surgery and guarantee the safety of surgery .

###24818609
OBJECTIVE	Attentional retraining ( AR ) is a potential new treatment for addiction .
OBJECTIVE	AR trains addicts to attend away from drug-related cues , thereby reducing exposure to drug cues and reducing craving .
OBJECTIVE	We examined the utility of delivering AR to smokers on a personal digital assistant ( PDA ) in the natural environment .
METHODS	Smokers ( N = 60 ) not seeking to quit were randomly assigned to an AR group or a control group ( i.e. , a group with no training ) .
METHODS	They carried a PDA with them for one week .
METHODS	They were prompted to complete four assessments daily , including three attentional retrainings ( AR group ) or three control trainings ( control group ) , and one evaluation of attentional bias .
METHODS	AR was implemented using a modified visual probe task .
METHODS	Attentional bias was assessed using a standard visual probe task on the PDA .
RESULTS	The AR group completed an average of 15.0 attentional retrainings and the control group completed an average of 14.9 control trainings .
RESULTS	As hypothesized , attentional bias declined over the week in the AR group , but not in the control group , Group Day interaction , F ( 1 , 232 ) = 4.77 , p = .03 .
RESULTS	AR also reduced craving ratings following a briefly presented picture containing smoking and nonsmoking features , group main effect , F ( 1 , 234 ) = 3.89 , p = .04 .
RESULTS	AR did not significantly influence smoking behavior .
CONCLUSIONS	AR can be administered on a mobile device in the natural environment , and AR can reduce attentional bias and craving .

###25250737
OBJECTIVE	Complicated grief ( CG ) is a debilitating condition , most prevalent in elderly persons .
OBJECTIVE	However , to our knowledge , no full-scale randomized clinical trial has studied CG in this population .
OBJECTIVE	To determine whether complicated grief treatment ( CGT ) produces greater improvement in CG and depressive symptoms than grief-focused interpersonal psychotherapy ( IPT ) .
METHODS	Randomized clinical trial enrolling 151 individuals 50 years or older ( mean [ SD ] age , 66.1 [ 8.9 ] years ) scoring at least 30 on the Inventory of Complicated Grief ( ICG ) .
METHODS	Participants were recruited from the New York metropolitan area from August 20 , 2008 , through January 7 , 2013 , and randomized to receive CGT or IPT .
METHODS	The main outcome was assessed at 20 weeks after baseline , with interim measures collected at 8 , 12 , and 16 weeks after baseline .
METHODS	Sixteen sessions of CGT ( n = 74 ) or IPT ( n = 77 ) delivered approximately weekly .
METHODS	Rate of treatment response , defined as a rating from an independent evaluator of much or very much improved on the Improvement subscale of the Clinical Global Impression Scale .
RESULTS	Both treatments produced improvement in CG symptoms .
RESULTS	Response rate for CGT ( 52 individuals [ 70.5 % ] ) was more than twice that for IPT ( 24 [ 32.0 % ] ) ( relative risk , 2.20 [ 95 % CI , 1.51-3 .22 ] ; P < .001 ) , with the number needed to treat at 2.56 .
RESULTS	Secondary analyses of CG severity and CG symptom and impairment questionnaire measures confirmed that CGT conferred a significantly greater change in illness severity ( 22 individuals [ 35.2 % ] in the CGT group vs 41 [ 64.1 % ] in the IPT group were still at least moderately ill [ P = .001 ] ) , rate of CG symptom reduction ( 1.05 ICG points per week for CGT vs 0.75 points per week for IPT [ t633 = 3.85 ; P < .001 ] ) , and the rate of improvement in CG impairment ( 0.63 work and Social Adjustment Scale points per week with CGT and 0.39 points per week with IPT [ t503 = 2.87 ; P = .004 ] ) .
RESULTS	Results were not moderated by participant age .
CONCLUSIONS	Complicated grief treatment produced clinically and statistically significantly greater response rates for CG symptoms than a proven efficacious treatment for depression ( IPT ) .
CONCLUSIONS	Results strongly support the need for physicians and other health care providers to distinguish CG from depression .
CONCLUSIONS	Given the growing elderly population , the high prevalence of bereavement in aging individuals , and the marked physical and psychological impact of CG , clinicians need to know how to treat CG in older adults .
BACKGROUND	clinicaltrials.gov Identifier : NCT01244295 .

###24503429
OBJECTIVE	To evaluate the clinical application of a dosing algorithm by genotypes in prediction of warfarin maintenance dose in Chinese patients with pulmonary thromboembolism .
METHODS	During October 2010 and August 2012 , 220 inpatients or outpatients with pulmonary embolism in Beijing Anzhen Hospital , were enrolled by the inclusion criteria .
METHODS	The patients included 86 males and 134 females .
METHODS	The clinical data and blood samples were collected .
METHODS	The fluorescent PCR genotyping method was used to detect the genotypes of vitamin K epoxy compounds reductase complex subunit 1 ( VKORC1 ) and cytochrome P450 enzyme 2C9 ( CYP2C9 ) .
METHODS	According to the random number table , the patients were randomly divided into a study group and a control group .
METHODS	In the study group , the first 3 doses of warfarin were prescribed according to the predicted warfarin dose , while in the control group the drug was prescribed according to the dose estimated empirically by clinicians .
METHODS	Warfarin was adjusted until it reached a stable dose according to the INR value , and the following-up lasted for 50 days .
RESULTS	AT the end of follow-up , the percentage of patients who obtained a stable dose in the study group and the control group was 82.1 % ( n = 78 ) and 66 % ( n = 64 ) , respectively .
RESULTS	The mean time to reach a stable dose in the study group and the control group was ( 16.8 1.5 ) and ( 25.6 1.8 ) days , and the median time was ( 11.0 1.0 ) days and ( 20.0 2.0 ) days , the difference between the 2 groups being statistically significant ( ( 2 ) = 18.175 , P < 0.001 ) .
RESULTS	The incidence of side effects of the study group was lower than that of the control group , and the time to the occurrence of side effects in study group was longer .
RESULTS	The average predicted dose of the 142 patients who reached a stable dose was ( 3.6 0.9 ) mg/d , and the average effective dose was ( 3.7 1.3 ) mg/d , the average predicted dose being lower than the actual dose ( 0.1 1.2 ) mg/d , but the difference was not significant ( t = -1.202 , P > 0.05 ) .
CONCLUSIONS	The warfarin stable dose prediction algorithm , containing genetic factors and non-heritage factors , can significantly shorten the adjustment time to reach warfarin stable dose , and reduce the incidence of side effects , and is clinically applicable .

###24814039
OBJECTIVE	It has been suggested that magnesium deficiency is associated with the triggering of acute phase response , which may contribute to type 2 diabetes and cardiovascular disease risk .
OBJECTIVE	We undertook this study to determine whether oral magnesium supplementation modifies serum levels of high-sensitivity C-reactive protein ( hsCRP ) in apparently healthy subjects with prediabetes and hypomagnesemia .
METHODS	A total of 62 men and non-pregnant women aged 18-65 year , with new diagnosis of prediabetes ( glucose 5.6 < 7.0 mmol/L and/or post-load glucose 7.7 < 11.1 mmol/L ) and hypomagnesemia ( serum magnesium levels < 0.74 mmol/L ) were enrolled in a clinical double-blind placebo-controlled trial and randomly allocated to receive either magnesium chloride ( 30 mL of MgCl2 5 % solution ) or NaHCO3 0.1 % solution , once daily for 3 months .
RESULTS	At basal conditions , anthropometric and biochemical variables were similarly distributed in both groups .
RESULTS	At the end of follow-up , participants who received magnesium chloride showed higher serum magnesium levels ( 0.86 0.08 vs. 0.69 0.16 mmol/L , p = 0.002 ) and lower hsCRP levels ( 4.8 15.2 vs. 17.1 21.0 nmol/L , p = 0.01 ) compared with participants in the control group .
CONCLUSIONS	Oral magnesium supplementation decreases hsCRP levels in apparently healthy subjects with prediabetes and hypomagnesemia .

###24739659
BACKGROUND	Chronic low back pain ( cLBP ) is a significant public health problem , being the primary cause of work absenteeism , as well as affecting sufferers ' quality of life , in industrialized society .
BACKGROUND	International guidelines recommend intensive multidisciplinary approaches for patients with cLBP .
BACKGROUND	However , these costly and time-consuming programs can only be offered to a minority of the most heavily affected patients and therefore do not seem likely to respond to public health requirements .
BACKGROUND	Lighter programs may be an alternative to full time hospital-based programs with valuable results in terms of disability and occupational activity for cLBP patients .
BACKGROUND	It is therefore important to define both what the determining components of management to improve activity restriction are and how to treat a larger number of patients more effectively at a lower cost .
BACKGROUND	The aim of this study is to compare three programs with various levels of intensity and multidisciplinary .
METHODS	This paper describes the protocol for a prospective , randomized , controlled , clinical trial in working aged patients with cLBP .
METHODS	Three treatment strategies are compared : ( 1 ) intensive and multidisciplinary program conducted in a rehabilitation center ; ( 2 ) less intensive outpatient program conducted by a private physiotherapist ; ( 3 ) mixed strategy combining the same out program with a multidisciplinary intervention .
METHODS	The primary outcome of the trial is the impact of the mixed strategy on being able to work compared to hospital centered-program and out program .
METHODS	The secondary outcome is the impact of the mixed strategy on quality of life and social ability compared to the two others programs .
METHODS	The intervention part of the trial programs will take 5 weeks and observational follow-up will take 12 months .
METHODS	The sample size will be 180 participants ( 60 for each arm ) .
METHODS	The project has been approved by the Ethical Committee of Angers Hospital , France .
CONCLUSIONS	On the hypothesis that a multidisciplinary approach is the key feature to programs success in reducing social and occupational impairment in cLBP patients , we suggest that it is possible to achieve the same results with less intensive strategies if a multidisciplinary approach is maintained .
BACKGROUND	Current Controlled Trials NCT02030171 .

###25560155
OBJECTIVE	To compare the safety and efficacy of isotonic versus hypotonic maintenance fluid in children .
METHODS	Randomized controlled trial .
METHODS	Tertiary-level teaching hospital .
METHODS	60 children ( age 0.5 to 12 years ) who were admitted and anticipated to receive intravenous fluid for the next 48 hours .
METHODS	Hypotonic fluid ( Standard maintenance volume as 0.18 % NaCl in 5 % dextrose ) or Isotonic fluid ( 60 % Standard maintenance volume as 0.9 % NaCl solution in 5 % dextrose ) .
METHODS	Primary : Incidence of hyponatremia .
METHODS	Secondary : Serum sodium , serum osmolality , blood sugar , blood urea , serum creatinine , serum potassium , serum chloride , pH , urine output , change in weight , morbidity and death .
RESULTS	At 24 hours , hyponatremia was noted in 7 ( 24 % ) patients in the isotonic and 16 ( 55 % ) in hypotonic group ( P = 0.031 ) .
RESULTS	At 48 hours , hyponatremia was noted in 4 ( 14 % ) and 13 ( 45 % ) patients in isotonic and hypotonic group , respectively ( P = 0.02 ) .
RESULTS	There was significant change in sodium levels in both isotonic ( P = 0.036 ) and hypotonic ( P < 0.001 ) intervention groups .
RESULTS	The peak fall in mean serum sodium level was noted at 24 hours ( -6.5 , 95 % CI : -3.5 , -9.6 mEq/L ; P < 0.001 ) in hypotonic group .
RESULTS	In isotonic group , there was significant increase between 24 and 48 hours ( 4.3 , 95 % CI : 0.1 , 8.4 mEq/L ; P = 0.04 ) .
CONCLUSIONS	Reduced volume isotonic fluid results in fewer episodes of hyponatremia than hypotonic fluid in sick children during the first 48 hours of intravenous fluid therapy .

###24660674
OBJECTIVE	In the current study , we compared measures of treatment outcome and engagement for Latino and non-Latino White patients receiving a cognitive behavioral therapy ( CBT ) program delivered in primary care .
METHODS	Participants were 18-65 years old and recruited from 17 clinics at 4 different sites to participate in a randomized controlled trial for anxiety disorders , which compared the Coordinated Anxiety Learning and Management ( CALM ) intervention ( consisting of CBT , medication , or both ) with usual care .
METHODS	Of those participants who were randomized to the intervention arm and selected CBT ( either alone or in combination with medication ) , 85 were Latino and 251 were non-Latino White ; the majority of the Latino participants received the CBT intervention in English ( n = 77 ) .
METHODS	Blinded assessments of clinical improvement and functioning were administered at baseline and at 6 , 12 , and 18 months after baseline .
METHODS	Measures of engagement , including attendance , homework adherence , understanding of CBT principles , and commitment to treatment , were assessed weekly during the CBT intervention .
RESULTS	Findings from propensity-weighted linear and logistic regression models revealed no statistically significant differences between Latinos and non-Latino Whites on symptom measures of clinical improvement and functioning at almost all time points .
RESULTS	There were significant differences on 2 of 7 engagement outcomes , namely , number of sessions attended and patients ' understanding of CBT principles .
CONCLUSIONS	These findings suggest that CBT can be an effective treatment approach for Latinos who are primarily English speaking and likely more acculturated , although continued attention should be directed toward engaging Latinos in such interventions .

###26237826
OBJECTIVE	To investigate the clinical effects of modified dachengqi tang ( DCQT ) on promoting gastrointestinal motility in post-operative esophageal cancer patients .
METHODS	Sixty postoperative esophageal cancer patients were enrolled and randomly assigned to the modified treatment group or the control group ( 30 patients in each group ) .
METHODS	Patients in the treatment group were given DCQT made from decocted herbs and administered via nasojejunal tube at a dosage of 150 mL .
METHODS	Gastrointestinal motility was assessed by recording time for recovery of bowel sounds , flatus , defecation , and the total amount of gastric drainage during the first three postoperative days .
METHODS	Plasma motilin ( MTL ) and vasoactive intestinal peptide ( VIP ) were measured one hour before and three days after surgery .
RESULTS	Compared with the control group , the times to first bowel sound , flatus , and defecation were significantly shorter and there was less gastric drainage in the treatment group ( P < 0.01 , P < 0.01 , P < 0.01 , and P < 0.05 , respectively ) .
RESULTS	In the treatment group , postoperative plasma MTL was significantly higher ( P < 0.01 ) and VIP was significantly lower than those in the control group ( P < 0.05 ) .
RESULTS	There was no difference found in either MTL or VIP from before to after operation in the treatment group ( P > 0.05 ) .
RESULTS	MTL was significantly lower and VIP was higher postoperatively in the control group , compared to before surgery ( P < 0.01 ) .
CONCLUSIONS	Modified DCQT effectively improved decreased gastrointestinal motility in postoperative esophageal cancer patients by increasing MTL and reducing VIP .

###25529351
BACKGROUND	Critically ill patients with respiratory failure undergoing bronchoscopy have an increased risk of hypoxaemia-related complications .
BACKGROUND	Previous studies have shown that in awake , hypoxaemic patients non-invasive ventilation ( NIV ) is helpful in preventing gas exchange deterioration during bronchoscopy .
BACKGROUND	An alternative and increasingly used means of oxygen delivery is its application via high-flow nasal cannula ( HFNC ) .
BACKGROUND	This study was conducted to compare HFNC with NIV in patients with acute hypoxaemic respiratory failure undergoing flexible bronchoscopy .
METHODS	Prospective randomised trial randomising 40 critically ill patients with hypoxaemic respiratory failure to receive either NIV or HFNC during bronchoscopy in the intensive care unit .
RESULTS	After the initiation of NIV and HFNC , oxygen levels were significantly higher in the NIV group compared to the HFNC group .
RESULTS	Two patients were unable to proceed to bronchoscopy after the institution of HFNC due to progressive hypoxaemia .
RESULTS	During bronchoscopy , one patient on HFNC deteriorated due to intravenous sedation requiring non-invasive ventilatory support .
RESULTS	Bronchoscopy was well tolerated in all other patients .
RESULTS	There were no significant differences between the two groups regarding heart rate , mean arterial pressure and respiratory rate .
RESULTS	Three patients in the NIV group and one patient in the HFNC group were intubated within 24 hours after the end of bronchoscopy ( P = 0.29 ) .
CONCLUSIONS	The application of NIV was superior to HFNC with regard to oxygenation before , during and after bronchoscopy in patients with moderate to severe hypoxaemia .
CONCLUSIONS	In patients with stable oxygenation under HFNC , subsequent bronchoscopy was well tolerated .
BACKGROUND	ClinicalTrials.gov NCT01870765 .
BACKGROUND	Registered 30 May 2013 .

###24507744
BACKGROUND	Surgical ablation ( SA ) is commonly used in atrial fibrillation ( AF ) patients undergoing cardiac surgery .
BACKGROUND	However , its effect has been established in few randomized studies .
BACKGROUND	To assess the complete atrial fibrillation free ( AF-free ) survival in randomized study assessing the effects of additional concomitant SA of AF in patients primarily indicated for other cardiac surgery .
METHODS	The PRAGUE-12 study was a prospective randomized study comparing the effect of adding SA to other cardiac surgery .
METHODS	We examined the data from the PRAGUE-12 trial and grouped patients according to complete AF-free survival .
METHODS	All patients had regular check-ups at 3 , 6 , 9 months , some of them with Holter recordings , and a final check-up at 12 months with Holter recording .
RESULTS	One hundred ninety-four patients were analyzed ; 104 originally randomized to surgery with adding SA ( SA group ) and 90 without it ( non-SA group ) .
RESULTS	Complete AF-free status was found in 46 patients from the SA group ( 44.2 % ) and 25 patients ( 27.8 % ) from the non-SA group ( p < 0.05 ) .
RESULTS	In a multivariate logistic regression , the SA group was associated with a greater chance for complete AF-free survival ( OR 1.87 , p < 0.05 ) .
RESULTS	In the multivariate analysis of the SA group , history of myocardial infarction ( OR 0.2 , p < 0.05 ) and a higher EuroSCORE ( OR 0.9 , p 0.05 ) were independently associated with a lower probability of AF-free survival .
CONCLUSIONS	Complete AF-free survival following SA was present in almost one half of patients .
CONCLUSIONS	Patients with a history of myocardial infarction and higher EuroSCOREs were less likely to benefit from an add-on SA procedure .

###25550013
OBJECTIVE	To compare the efficacy of autologous blood injection versus corticosteroid injection for lateral epicondylitis .
METHODS	21 men and 59 women ( mean age , 45.2 years ) presenting with lateral epicondylitis were randomised to receive either autologous blood injection ( 2 ml of autologous venous blood mixed with 1 ml of 2 % prilocaine hydrochloride ) or corticosteroid injection ( 1 ml of 40 mg methylprednisolone acetate mixed with 1 ml of 2 % prilocaine hydrochloride ) given by a single physician .
METHODS	Patients were assessed before ( day 0 ) and after ( days 15 , 30 , and 90 ) treatment for elbow pain ( using a visual analogue scale [ VAS ] ) , function ( using the patient-rated tennis elbow evaluation [ PRTEE ] questionnaire ) , and grip strength ( using a hydraulic hand dynamometer ) .
METHODS	Patients were followed up at 6 months by telephone to assess elbow pain using the VAS .
RESULTS	No complications ( infection , skin atrophy , neurovascular damage , or tendon rupture ) were noted .
RESULTS	10 patients reported increased pain for up to 2 days after autologous blood injection .
RESULTS	In both groups , the VAS score for elbow pain , PRTEE score , and grip strength improved significantly after treatment ( p = 0.0001 ) , but the pattern of improvement differed .
RESULTS	Compared with autologous blood injection , corticosteroid injection improved all 3 scores at a faster rate over the first 15 days ( p = 0.0001 ) , and then started to decline slightly until day 90 .
RESULTS	After autologous blood injection , all 3 scores improved steadily and were eventually better ( p = 0.0001 ) .
RESULTS	If a 37 % decrease in PRTEE is defined as complete recovery , 38 ( 95 % ) of patients with autologous blood injection and 25 ( 62.5 % ) of patients with corticosteroid injection achieved complete recovery ( p = 0.0001 ) .
CONCLUSIONS	Autologous blood injection was more effective over the follow-up period than corticosteroid injection in improving pain , function , and grip strength .
CONCLUSIONS	It is recommended as a first-line injection treatment because it is simple , cheap , and effective .

###25677790
BACKGROUND	Among CT scanners , 320-row instruments feature decreased photon energy and yield strong contrast enhancement .
BACKGROUND	Consequently , the contrast medium ( CM ) dose can be reduced .
BACKGROUND	The results of low-tube-voltage coronary CT angiography ( CCTA ) performed on 320-row scanners have not been adequately assessed .
OBJECTIVE	We evaluated the effects of a low-contrast-dose protocol on the image quality of CCTA using 80 kVp tube voltage , iterative reconstruction ( IR ) , and a 320-row scanner .
METHODS	We randomly assigned 90 patients ( mean body weight , 56.5 11.0 kg ) to 1 of 3 CCTA protocols .
METHODS	Under protocol A , 30 were scanned using a conventional 120-kVp protocol and a standard CM dose ( 280 mg iodine/kg body weight [ mgI/kg ] ) .
METHODS	Another 30 underwent scanning at 80 kVp with a 25 % CM dose reduction ( 210 mgI/kg ; protocol B ) .
METHODS	Under protocol C , the remaining 30 patients were scanned at 80 kVp with a 50 % CM dose reduction ( 140 mgI/kg ) .
METHODS	The 120 and 80 kVp images were processed with IR .
METHODS	Images obtained under the 3 protocols were subjected to quantitative and qualitative analysis .
RESULTS	The amount of CM used in protocol A , B , and C was 43.6 10.1 , 30.3 4.4 , and 21.0 4.0 mL , respectively .
RESULTS	Mean CT attenuation of the coronary arteries tended to be higher under protocol B than the other 2 protocols .
RESULTS	The contrast-to-noise ratio was significantly higher under protocol B.
RESULTS	The mean visual scores were significantly higher for protocols A and B than protocol C.
RESULTS	The mean effective radiation dose was significantly lower under the 80-kVp protocol .
CONCLUSIONS	With a 320-row scanner and our refined CM injection and timing protocol , it is technically feasible to obtain sufficient vascular enhancement with a reduction in the CM and/or radiation dose at 80-kVp CCTA with IR .

###24480106
OBJECTIVE	Evaluate the sensitivity and specificity of pelvic ultrasound ( US ) and abdominopelvic computed tomography ( CT ) for the identification of ovarian torsion in women presenting to the emergency department with acute lower abdominal or pelvic pain .
METHODS	This is a retrospective study of 20 cases of ovarian torsion and 20 control patients , all of whom had both US and CT performed in the emergency department .
METHODS	Two radiologists who were blinded to clinical data interpreted all studies as ( 1 ) demonstrating an abnormal ovary or not , and ( 2 ) suggestive of torsion or not .
METHODS	Sensitivity , specificity and interobserver variation were calculated for each imaging modality .
RESULTS	Pelvic US was interpreted as demonstrating an abnormal ovary in 90.0 % of ovarian torsion cases by reader 1 , and in 100.0 % by reader 2 , whereas CT was interpreted as revealing an abnormal ovary in 100.0 % of torsion cases by both readers .
RESULTS	Pelvic US for ovarian torsion was 80.0 % sensitive ( 95 % CI , 58.4-91 .9 % ) and 95.0 % specific ( 95 % CI , 76.4-99 .1 % ) for reader 1 , while 80.0 % sensitive ( 95 % CI , 58.4-91 .9 % ) and 85.0 % specific ( 95 % CI , 64.0-95 .0 % ) for reader 2 .
RESULTS	Interobserver agreement for pelvic US was fair ( Kappa = 0.60 ) .
RESULTS	Abdominopelvic CT for ovarian torsion was 100.0 % sensitive ( 95 % CI , 83.9-100 .0 % ) and 85.0 % specific ( 95 % CI , 64.0-94 .5 % ) for reader 1 , while 90.0 % sensitive ( 95 % CI , 69.9-97 .2 % ) and 90.0 % specific ( 95 % CI , 69.9-97 .2 % ) for reader 2 .
RESULTS	Interobserver agreement was excellent ( Kappa = 0.85 ) .
CONCLUSIONS	The diagnostic performance of CT is not shown to be significantly different from that of US in identifying ovarian torsion in this study .
CONCLUSIONS	These results suggest that when CT demonstrates findings of ovarian torsion , the performance of another imaging exam ( i.e. US ) that delays therapy is unlikely to improve preoperative diagnostic yield .

###25116690
BACKGROUND	Previous research reveals an association between traumatic stress and an increased risk for numerous diseases , including cancer .
BACKGROUND	At the molecular level , stress may increase carcinogenesis via increased DNA damage and impaired DNA repair mechanisms .
BACKGROUND	We assessed DNA breakage in peripheral blood mononuclear cells from individuals with post-traumatic stress disorder ( PTSD ) and measured the cellular capacity to repair single-strand breaks after exposure to ionizing X-radiation .
BACKGROUND	We also investigated the effect of psychotherapy on both DNA breakage and DNA repair .
METHODS	In a first study we investigated DNA breakage and repair in 34 individuals with PTSD and 31 controls .
METHODS	Controls were subdivided into 11 trauma-exposed subjects and 20 individuals without trauma exposure .
METHODS	In a second study , we analysed the effect of psychotherapy ( Narrative Exposure Therapy ) on DNA breakage and repair .
METHODS	Thirty-eight individuals with PTSD were randomly assigned to either a treatment or a waitlist control condition .
METHODS	Follow-up was performed 4 months and 1 year after therapy .
RESULTS	In study 1 we found higher levels of basal DNA breakage in individuals with PTSD and trauma-exposed subjects than in controls , indicating that traumatic stress is associated with DNA breakage .
RESULTS	However , single-strand break repair was unimpaired in individuals with PTSD .
RESULTS	In study 2 , we found that psychotherapy reversed not only PTSD symptoms , but also DNA strand break accumulation .
CONCLUSIONS	Our results show - for the first time in vivo - an association between traumatic stress and DNA breakage ; they also demonstrate changes at the molecular level , i.e. , the integrity of DNA , after psychotherapeutic interventions .

###25230144
BACKGROUND	Postoperative pain remains an important challenge after scoliosis surgery in children .
BACKGROUND	Opioids are the mainstay of treatment , and adult studies demonstrate gabapentin as a useful adjunct to opioids in the management of postoperative pain .
METHODS	Adolescent patients undergoing idiopathic scoliosis surgery were randomized to receive a single preoperative dose of gabapentin 600mg or placebo .
METHODS	The primary outcome measure was total morphine consumption in mgkg ( -1 ) between 0 and 24h postoperatively .
METHODS	Secondary outcome measures included time to first rescue analgesia , pain intensity scores at rest and with movement , incidence of nausea , vomiting , pruritus , sedation , dizziness , presence of persisting pain symptoms , and patient satisfaction .
METHODS	Cumulative opioid consumption was calculated at each time point : 1 , 4 , 8 , 12 , 24 , 48 , and 72h .
RESULTS	The gabapentin group used 0.0870.06 mgkg ( -1 ) of morphine at 1h , 0.240.12 mgkg ( -1 ) at 4h , 0.440.17 mgkg ( -1 ) at 8h , and 1.290.44 mgkg ( -1 ) at 24h .
RESULTS	The placebo group used 0.1210.06 mgkg ( -1 ) of morphine at 1h , 0.350.16 mgkg ( -1 ) at 4h , 0.560.27 mgkg ( -1 ) at 8h , and 1.460.68 mgkg ( -1 ) at 24h .
RESULTS	There was no statistically significant reduction in opioid consumption in the patients receiving gabapentin .
RESULTS	There were no significant differences in secondary outcomes .
CONCLUSIONS	A single preoperative dose of gabapentin did not show a significant difference in opioid consumption or pain scores in adolescents undergoing idiopathic scoliosis surgery .
CONCLUSIONS	This study is the first pediatric randomized controlled trial to assess the effectiveness of a single dose of gabapentin on morphine consumption and analgesia following major surgery .

###24727261
OBJECTIVE	To evaluate transient , large visual acuity ( VA ) decreases , termed sporadic vision loss , during anti-vascular endothelial growth factor treatment for neovascular age-related macular degeneration ( AMD ) .
METHODS	Cohort within a randomized clinical trial .
METHODS	setting : Comparison of Age-Related Macular Degeneration Treatments Trials ( CATT ) .
METHODS	study population : Total of 1185 CATT patients .
METHODS	main outcome measures : Incidence of sporadic vision loss and odds ratio ( OR ) for association with patient and ocular factors .
METHODS	Sporadic vision loss was a decline of 15 letters from the previous visit , followed by a return at the next visit to no more than 5 letters worse than the visit before the VA loss .
RESULTS	There were 143 sporadic vision loss events in 122 of 1185 patients ( 10.3 % ) .
RESULTS	Mean VA at 2 years for those with and without sporadic vision loss was 58.5 ( 20/63 ) and 68.4 ( 20/40 ) letters , respectively ( P < .001 ) .
RESULTS	Among patients treated pro re nata , no injection was given for 27.6 % ( 27/98 ) of sporadic vision loss events .
RESULTS	Multivariate analysis demonstrated that baseline predictors for sporadic vision loss included worse baseline VA ( OR 2.92 , 95 % confidence interval [ CI ] :1.65 -5.17 for 20/200 compared with 20/40 ) , scar ( OR 2.21 , 95 % CI :1.22 -4.01 ) , intraretinal foveal fluid on optical coherence tomography ( OR 1.80 , 95 % CI :1.11 -2.91 ) , and medical history of anxiety ( OR 1.90 , 95 % CI :1.12 -3.24 ) and syncope ( OR 2.75 , 95 % CI :1.45 -5.22 ) .
RESULTS	Refraction decreased the likelihood of sporadic vision loss ( OR 0.62 , 95 % CI : 0.42-0 .91 ) .
CONCLUSIONS	Approximately 10 % of CATT patients had sporadic vision loss .
CONCLUSIONS	Baseline predictors included AMD-related factors and factors independent of AMD .
CONCLUSIONS	These data are relevant for clinicians in practice and those involved in clinical trials .

###24323698
OBJECTIVE	This study sought to evaluate the safety and effectiveness of drug-eluting stents ( DES ) compared to bare-metal stents ( BMS ) for patients with large coronary vessels .
BACKGROUND	Randomized trials have demonstrated that DES reduce the risk of target vessel revascularization ( TVR ) compared to BMS .
BACKGROUND	This benefit is less pronounced as artery diameter increases .
BACKGROUND	Whether DES are superior to BMS for larger coronary arteries in the setting of routine clinical practice is unknown .
METHODS	We analyzed data from 869 patients undergoing de novo lesion PCI with reference vessel diameter greater than or equal to 3.5 mm in the NHLBI Dynamic Registry according to whether they were treated with DES or BMS .
METHODS	Patients were followed for 3 years for the occurrence of cardiovascular events .
RESULTS	At 3-year follow-up , rates of TVR at 3 years were similar and low in both groups ( 4.4 % vs. 3.7 % , P = 0.62 ) .
RESULTS	After adjustment for differences in baseline characteristics , the adjusted hazard ratio for 3-year MI for DES was 1.85 ( 95 % CI 0.93-3 .7 , P = 0.08 ) , for TVR at 3 years 1.14 ( 95 % CI 0.52-2 .49 , P = 0.75 ) and for mortality 0.89 ( 95 % CI 0.49-1 .62 , P = 0.71 ) .
CONCLUSIONS	In our study of the unrestricted use of DES for patients with lesions in larger diameter coronary arteries , first generation DES did not reduce 3-year risk of TVR .
CONCLUSIONS	Our findings do not support the preferred use of DES over BMS for patients with lesions located in arteries > 3.5 mm .
CONCLUSIONS	It is unknown whether secondary generation DES can offer better outcome compared to BMS in large coronary vessels .
CONCLUSIONS	Further study on this issue is warranted .

###24486163
BACKGROUND	Informal caregivers play an important role in hospital-at-home schemes .
BACKGROUND	However they may increase their burden , especially chronic diseases , like COPD .
BACKGROUND	In the absence of clear differences in effectiveness and cost-effectiveness between hospital-at-home and usual hospital care , informal caregiver preferences play an important role .
BACKGROUND	This study investigated informal caregiver strain , satisfaction and preferences for place of treatment with a community-based hospital-at-homes scheme for COPD exacerbations .
METHODS	The study was part of a larger randomised controlled trial .
METHODS	By randomisation , patients were allocated to usual hospital care or hospital-at-home , which included discharge at day 4 of admission , followed by home treatment with homes visits by community nurses until day 7 of treatment .
METHODS	Patients allocated to usual hospital care received care as usual in the hospital and were discharged at day 7 .
METHODS	Patients were asked if they had an informal caregiver and who this was .
METHODS	Patients and their caregivers were followed for 90 days .
METHODS	Informal caregiver strain was assessed with the caregiver strain index .
METHODS	Satisfaction and preference were assessed using questionnaires .
METHODS	All measurements were performed at the end of the 7-day treatment and the end of the 90-days follow-up .
RESULTS	Of the 139 patients , 124 had an informal caregiver , of whom three-quarter was the patients ' spouse .
RESULTS	There was no significant difference in caregiver strain between hospital-at-home and usual hospital care at both time points ( mean difference at T +4 days 0.47 95 % CI -0.96 to 1.91 , p = 0.514 ; mean difference at T +90 days 0.36 95 % CI -1.85 to 1.35 , p = 0.634 ) .
RESULTS	At the end of the 7-day treatment , 33 % ( N = 15 ) of caregivers of patients allocated to hospital treatment and 71 % ( N = 37 ) of caregivers of patients allocated to home treatment preferred home treatment , if they could choose .
RESULTS	Caregivers were satisfied with the treatment the patient received within hospital-at-home .
CONCLUSIONS	There were no differences in caregiver strain between the community-based hospital-at-home scheme and usual hospital care .
CONCLUSIONS	Most caregivers were satisfied with the treatment .
CONCLUSIONS	In addition to other outcomes , our results support the wider implementation of hospital-at-home for COPD exacerbations .

###25034199
OBJECTIVE	To evaluate a new format of a summary , which presents research from synthesized evidence to patients and the public .
METHODS	We conducted a randomized controlled trial in 143 members of the public from five countries ( Canada , Norway , Spain , Argentina , and Italy ) .
METHODS	Participants received either a new summary format ( a plain language summary [ PLS ] ) or the current format used in Cochrane systematic reviews .
METHODS	The new PLS presents information about the condition and intervention , a narrative summary of results , and a table of results with absolute numbers for effects of the intervention and quality of the evidence using Grading of Recommendations Assessment , Development , and Evaluation .
RESULTS	With the new PLS , more participants understood the benefits and harms and quality of evidence ( 53 % vs. 18 % , P < 0.001 ) ; more answered each of the five questions correctly ( P 0.001 for four questions ) ; and they answered more questions correctly , median 3 ( interquartile range [ IQR ] : 1-4 ) vs. 1 ( IQR : 0-1 ) , P < 0.001 ) .
RESULTS	Better understanding was independent of education level .
RESULTS	More participants found information in the new PLS reliable , easy to find , easy to understand , and presented in a way that helped make decisions .
RESULTS	Overall , participants preferred the new PLS .
CONCLUSIONS	This new PLS format for patients and the public is a promising tool to translate evidence from synthesized research .

###25618970
OBJECTIVE	To observe the clinical effect of Gushenyutai plaster administered at the Guanyuan ( CV 4 ) acupoint on male infertility associated with semen non-liquefaction .
METHODS	Sixty-two male patients with infertility caused by semen non-liquefaction were randomized into a treatment and control group .
METHODS	The control group received comprehensive therapy , which included oral administration of clarithromycin sustained release tablets , hip bath with Zhongyaoxiaoyan granules , prostate massage , and transurethral microwave treatment .
METHODS	The treatment group was administered Gushenyutai plaster in addition to the comprehensive therapy .
METHODS	Both groups were treated for 8 weeks .
METHODS	After treatment , the clinical effect and pregnancy rate were assessed and compared between the two groups .
RESULTS	The effective rate of the treatment group was significantly higher than that of the control group ( 96.77 % vs 70.97 % , P < 0.05 ) and the pregnancy rates of the treatment group and control groups were 38.71 % and 16.13 % , respectively ( P < 0.05 ) .
CONCLUSIONS	The effect of Gushenyutai plaster plus comprehensive therapy was better than that of the comprehensive therapy alone on male infertility induced by semen non-liquefaction .

###24803033
OBJECTIVE	To evaluate the efficacy of sodium butyrate enemas ( NABUREN ) in prostate cancer radiation therapy ( RT ) in reducing the incidence , severity , and duration of acute RT-induced proctitis .
METHODS	166 patients , randomly allocated to 1 of 4 groups ( rectal sodium butyrate 1 g , 2 g , or 4 g daily or placebo ) , were treated with NABUREN during and 2 weeks after RT. .
METHODS	The grade of proctitis was registered in a daily diary .
METHODS	The correlation between NABUREN and proctitis was investigated through ( 2 ) statistics .
METHODS	The toxicity endpoints considered were as follows : total number of days with grade 1 proctitis ( G1 ) ; total number of days with grade 2 proctitis ( G2 ) ; G1 and G2 proctitis lasting at least 3 and 5 consecutive days starting from week 4 ( G1 +3 d , G2 +3 d ) ; damaging effects of RT on rectal mucosa as measured by endoscopy .
METHODS	The relationship between endpoints and pretreatment morbidities , hormonal therapy , presence of diabetes or hypertension , abdominal surgery , or hemorrhoids was investigated by univariate analysis .
RESULTS	The patients were randomly allocated to the 4 arms .
RESULTS	No difference in the distribution of comorbidities among the arms was observed ( P > .09 ) .
RESULTS	The mean G1 and G2 proctitis were 7.8 and 4.9 for placebo and 8.9 and 4.7 for the NABUREN group , respectively .
RESULTS	No favorable trend in reduction of incidence , severity , and duration of G1 and G2 proctitis was observed with NABUREN use .
RESULTS	In univariate analysis , G1 +3 d toxicity was found to be related to hemorrhoids ( P = .008 ) , and a slight correlation was found between G2 proctitis and hormonal therapy ( P = .06 ) .
RESULTS	The RT effects on rectal mucosa as based on endoscopic assessment were mainly related to diabetes ( P < .01 ) .
RESULTS	Endoscopy data at 6 week showed no significant difference between the placebo and butyrate arms .
RESULTS	The other investigated endpoints were not correlated with any of the clinical risk factors analyzed .
CONCLUSIONS	There was no evidence of efficacy of NABUREN in reducing the incidence , severity , and duration of acute radiation proctitis .
CONCLUSIONS	There was a correlation between some endpoints and clinical risk factors .

###25926506
BACKGROUND	Phenylalanine , which is an essential aromatic amino acid , is either used for protein synthesis or irreversibly hydroxylated to tyrosine .
BACKGROUND	The provision of optimal amounts of dietary phenylalanine is not only important for growth and development but might also influence catecholamine synthesis and release rates .
BACKGROUND	The current recommended aromatic amino acid requirement for infants aged 0-6 mo is based on the amino acid content of human milk .
OBJECTIVE	We quantified the requirements for phenylalanine in the presence of excess tyrosine ( 166 or 177 mg/kg per day for term and preterm infants , respectively ) for term and preterm neonates by using the indicator amino acid oxidation method with l - [ 1 - ( 13 ) C ] lysine 2HCl as an indicator .
OBJECTIVE	Hence , we determined the minimum obligatory phenylalanine requirement .
METHODS	Fully enterally fed term and preterm infants received randomly graded amounts of phenylalanine ( 5-177 mg/kg per day ) as part of an elemental formula .
METHODS	Data are expressed as means SDs .
RESULTS	Twenty term ( birth weight : 3.19 0.34 kg ; gestational age : 38.9 1 wk ) and 16 preterm ( birth weight : 1.75 0.17 kg ; gestational age : 32.5 0.6 wk ) Asian infants participated at a postnatal age of 17 8 d.
RESULTS	In total , 44 studies were performed .
RESULTS	The minimum obligatory phenylalanine requirement was 58 mg/kg per day ( 95 % CI : 38-78 mg/kg per day ) and 80 mg/kg per day ( 95 % CI : 40-119 mg/kg per day ) for term and preterm infants , respectively .
CONCLUSIONS	The determined mean phenylalanine-requirement estimates are lower than the contents of term and preterm formulas currently on the market .
CONCLUSIONS	This trial was registered at www.trialregister.nl as NTR1610 .

###25391338
BACKGROUND	Cryptococcal meningitis ( CM ) is a severe AIDS-defining illness with 90-day case mortality as high as 70 % in sub-Saharan Africa , despite treatment .
BACKGROUND	It is the leading cause of death in HIV patients in Asia and Africa.No major advance has been made in the treatment of CM since the 1970s .
BACKGROUND	The mainstays of induction therapy are amphotericin B and flucytosine , but these are often poorly available where the disease burden is highest .
BACKGROUND	Adjunctive treatments , such as dexamethasone , have had dramatic effects on mortality in other neurologic infections , but are untested in CM .
BACKGROUND	Given the high death rates in patients receiving current optimal treatment , and the lack of new agents on the horizon , adjuvant treatments , which offer the potential to reduce mortality in CM , should be tested.The principal research question posed by this study is as follows : does adding dexamethasone to standard antifungal therapy for CM reduce mortality ?
BACKGROUND	Dexamethasone is a cheap , readily available , and practicable intervention .
METHODS	A double-blind placebo-controlled trial with parallel arms in which patients are randomised to receive either dexamethasone or placebo , in addition to local standard of care .
METHODS	The study recruits patients in both Asia and Africa to ensure the relevance of its results to the populations in which the disease burden is highest .
METHODS	The 10-week mortality risk in the control group is expected to be between 30 % and 50 % , depending on location , and the target hazard ratio of 0.7 corresponds to absolute risk reductions in mortality from 30 % to 22 % , or from 50 % to 38 % .
METHODS	Assuming an overall 10-week mortality of at least 30 % in our study population , recruitment of 824 patients will be sufficient to observe the expected number of deaths .
METHODS	Allowing for some loss to follow-up , the total sample size for this study is 880 patients .
METHODS	To generate robust evidence across both continents , we aim to recruit roughly similar numbers of patients from each continent .
METHODS	The primary end point is 10-week mortality .
METHODS	Ethical approval has been obtained from Oxford University 's Tropical Research Ethics Committee ( OxTREC ) , and as locally mandated at each site .
BACKGROUND	International Standard Randomised Controlled Trial Number : ISRCTN59144167 26-July-2012 .

###25545309
OBJECTIVE	To investigate whether electro-acupuncture or physical exercise influence serum anti-Mllerian hormone ( AMH ) , antral follicle count ( AFC ) or ovarian volume in women with polycystic ovary syndrome ( PCOS ) .
METHODS	Secondary analyses of a prospective , randomized controlled clinical trial .
METHODS	University Hospital , Sweden .
METHODS	Seventy-four women with PCOS recruited from the general population .
METHODS	Women with PCOS were randomized to 16 weeks of electro-acupuncture ( 14 treatments ) , exercise ( at least three times/week ) , or no intervention .
METHODS	Serum AMH recorded at baseline , after 16 weeks of intervention , and at follow up at 32 weeks .
METHODS	AFC , and ovarian volume assessed by magnetic resonance imaging at baseline and at follow up at 32 weeks .
RESULTS	After 16 weeks of intervention , serum levels of AMH were significantly decreased in the electro-acupuncture group by 17.5 % ( p < 0.001 ) , and differed from the change in the exercise group .
RESULTS	AMH remained decreased by 15 % ( p = 0.004 ) also at follow up at 32 weeks , but did not differ from the exercise or the no intervention groups .
RESULTS	There was a decrease by 8.5 % ( p = 0.015 ) in ovarian volume between baseline and follow up in the electro-acupuncture group , and by 11.7 % ( p = 0.01 ) in AFC in the physical exercise group .
RESULTS	No other variables were affected .
CONCLUSIONS	This study is the first to demonstrate that acupuncture reduces serum AMH levels and ovarian volume .
CONCLUSIONS	Physical exercise did not influence circulating AMH or ovarian volume .
CONCLUSIONS	Despite a within-group decrease in AFC , exercise did not lead to a between-group difference .

###25427656
OBJECTIVE	To evaluate outcomes of a registered nurse-led care management intervention for disabled Medicaid beneficiaries with high health care costs .
METHODS	Washington State Department of Social and Health Services Client Outcomes Database , 2008-2011 .
METHODS	In a randomized controlled trial with intent-to-treat analysis , outcomes were compared for the intervention ( n = 557 ) and control groups ( n = 563 ) .
METHODS	A quasi-experimental subanalysis compared outcomes for program participants ( n = 251 ) and propensity score-matched controls ( n = 251 ) .
METHODS	Administrative data were linked to describe costs and use of health services , criminal activity , homelessness , and death .
RESULTS	In the intent-to-treat analysis , the intervention group had higher odds of outpatient mental health service use and higher prescription drug costs than controls in the postperiod .
RESULTS	In the subanalysis , participants had fewer unplanned hospital admissions and lower associated costs ; higher prescription drug costs ; higher odds of long-term care service use ; higher drug/alcohol treatment costs ; and lower odds of homelessness .
CONCLUSIONS	We found no health care cost savings for disabled Medicaid beneficiaries randomized to intensive care management .
CONCLUSIONS	Among participants , care management may have the potential to increase access to needed care , slow growth in the number and therefore cost of unplanned hospitalizations , and prevent homelessness .
CONCLUSIONS	These findings apply to start-up care management programs targeted at high-cost , high-risk Medicaid populations .

###25911859
OBJECTIVE	PROGRESS randomized chronic hepatitis C genotype 1 patients with a baseline viral load 400,000 IU/mL weighing 85 kg to regimens of 180 g/week for 48 weeks or 360 g/week for 12 weeks followed by 180 g/week for 36 weeks peginterferon alfa-2a plus ribavirin .
OBJECTIVE	This analysis explored pharmacokinetics and early viral kinetics ( VK ) and evaluates differences between groups .
METHODS	Blood samples for pharmacokinetic and VK analyses were collected from 51 patients enrolled in the PROGRESS study .
RESULTS	Mean peginterferon alfa-2a trough concentration at week 12 was 11.74.3 ng/mL for 180 g and 23.411.3 ng/mL for 360 g. Early VK profiles suggested a trend towards an enhanced viral decline in the 360 g groups with a mean decrease in HCV RNA at 48 hours post first dose of 1.04 log10 ( IU/mL ) compared with 0.76 log10 ( IU/mL ) in the 180 g groups .
RESULTS	Mean beta slope increased with dose , ranging from 0.380.26 log10 IU/week at 180 g to 0.520.32 log10 IU/week at 360 g.
CONCLUSIONS	Early viral de clines may be enhanced with the 360 g dose .
CONCLUSIONS	These data may suggest the utility of high-dose peginterfer on alfa-2a plus direct-acting antivirals ( DAA ) in select difficult-to-treat populations .

###24510942
OBJECTIVE	This article reports the results of a community-based , culturally tailored diabetes prevention program for overweight Mexican American adults on weight loss , waist circumference , diet and physical activity self-efficacy , and diet behaviors .
METHODS	The intervention used content from the Diabetes Prevention Program but culturally tailored the delivery methods into a community-based program for Spanish-speaking adults of Mexican descent .
METHODS	The design was a randomized controlled trial ( N = 58 ) comparing the effects of a 5-month educational intervention with an attention control group .
METHODS	The primary study outcome was weight loss .
METHODS	Secondary outcomes included change in waist circumference , body mass index , diet self-efficacy , and physical activity self-efficacy .
RESULTS	There were significant intervention effects for weight , waist circumference , body mass index , and diet self-efficacy , with the intervention group doing better than the control group .
RESULTS	These effects did not change over time .
CONCLUSIONS	Findings support the conclusion that a community-based , culturally tailored intervention is effective in reducing diabetes risk factors in a 5-month program .

###24963111
OBJECTIVE	Salsalate treatment has been shown to improve glucose homeostasis , but the mechanism remains unclear .
OBJECTIVE	The aim of this study was to evaluate the effect of salsalate treatment on insulin action , secretion , and clearance rate in nondiabetic individuals with insulin resistance .
METHODS	This was a randomized ( 2:1 ) , single-blind , placebo-controlled study of salsalate ( 3.5 g daily for 4 weeks ) in nondiabetic individuals with insulin resistance .
METHODS	All individuals had measurement of glucose tolerance ( 75-g oral glucose tolerance test ) , steady-state plasma glucose ( SSPG ; insulin suppression test ) , and insulin secretion and clearance rate ( graded-glucose infusion test ) before and after treatment .
RESULTS	Forty-one individuals were randomized to salsalate ( n = 27 ) and placebo ( n = 14 ) .
RESULTS	One individual from each group discontinued the study .
RESULTS	Salsalate improved fasting ( % mean change -7 % [ 95 % CI -10 to -14 ] vs. 1 % [ -3 to 5 ] , P = 0.005 ) but not postprandial glucose concentration compared with placebo .
RESULTS	Salsalate also lowered fasting triglyceride concentration ( -25 % [ -34 to -15 ] vs. -6 % [ -26 to 14 ] , P = 0.04 ) .
RESULTS	Salsalate had no effect on SSPG concentration or insulin secretion rate but significantly decreased insulin clearance rate compared with placebo ( -23 % [ -30 to -16 ] vs. 3 % [ -10 to 15 ] , P < 0.001 ) .
RESULTS	Salsalate was well tolerated , but four individuals needed a dose reduction due to symptoms .
CONCLUSIONS	Salsalate treatment in nondiabetic , insulin-resistant individuals improved fasting , but not postprandial , glucose and triglyceride concentration .
CONCLUSIONS	These improvements were associated with a decrease in insulin clearance rate without change in insulin action or insulin secretion .

###24485178
OBJECTIVE	Myringotomy and tympanostomy tube insertion ( MT ) is a common surgical procedure .
OBJECTIVE	Although surgical simulation has proven to be an effective training tool , an anatomically sound simulation model for MT is lacking .
OBJECTIVE	We developed such a model and assessed its impact on the operating room performance of senior medical students .
METHODS	Prospective randomized trial .
METHODS	A randomized single-blind controlled study of simulation training with the MT model versus no simulation training .
METHODS	Each participant was randomized to either the simulation model group or control group , after performing an initial MT procedure .
METHODS	Within two weeks of the first procedure , the students performed a second MT. All procedures were performed on real patients and rated with a Global Rating Scale by two attending otolaryngologists .
METHODS	Time to complete the MT was also recorded .
RESULTS	Twenty-four senior medical students were enrolled .
RESULTS	Control and intervention groups did not differ at baseline on their Global Rating Scale score or time to complete the MT procedure .
RESULTS	Following simulation training , the study group received significantly higher scores ( P = .005 ) and performed the MT procedure in significantly less time ( P = .034 ) .
RESULTS	The control group did not improve their performance scores ( P > .05 ) or the time to complete the procedure ( P > .05 ) .
CONCLUSIONS	Our surgical simulation model shows promise for being a valuable teaching tool for MT for senior medical students .
CONCLUSIONS	Such anatomically appropriate physical simulators may benefit teaching of junior trainees .

###24943000
BACKGROUND	Evidence concerning the importance of glucose lowering in the prevention of cardiovascular ( CV ) outcomes remains controversial .
BACKGROUND	Given the multi-faceted pathogenesis of atherosclerosis in diabetes , it is likely that any intervention to mitigate this risk must address CV risk factors beyond glycemia alone .
BACKGROUND	The SGLT-2 inhibitor empagliflozin improves glucose control , body weight and blood pressure when used as monotherapy or add-on to other antihyperglycemic agents in patients with type 2 diabetes .
BACKGROUND	The aim of the ongoing EMPA-REG OUTCOME trial is to determine the long-term CV safety of empagliflozin , as well as investigating potential benefits on macro - / microvascular outcomes .
METHODS	Patients who were drug-nave ( HbA1c 7.0 % and 9.0 % ) , or on background glucose-lowering therapy ( HbA1c 7.0 % and 10.0 % ) , and were at high risk of CV events , were randomized ( 1:1:1 ) and treated with empagliflozin 10 mg , empagliflozin 25 mg , or placebo ( double blind , double dummy ) superimposed upon the standard of care .
METHODS	The primary outcome is time to first occurrence of CV death , non-fatal myocardial infarction , or non-fatal stroke .
METHODS	CV events will be prospectively adjudicated by an independent Clinical Events Committee .
METHODS	The trial will continue until 691 confirmed primary outcome events have occurred , providing a power of 90 % to yield an upper limit of the adjusted 95 % CI for a hazard ratio of < 1.3 with a one-sided of 0.025 , assuming equal risks between placebo and empagliflozin ( both doses pooled ) .
METHODS	Hierarchical testing for superiority will follow for the primary outcome and key secondary outcomes ( time to first occurrence of CV death , non-fatal myocardial infarction , non-fatal stroke or hospitalization for unstable angina pectoris ) where non-inferiority is achieved .
RESULTS	Between Sept 2010 and April 2013 , 592 clinical sites randomized and treated 7034 patients ( 41 % from Europe , 20 % from North America , and 19 % from Asia ) .
RESULTS	At baseline , the mean age was 639 years , BMI 30.65.3 kg/m2 , HbA1c 8.10.8 % , and eGFR 7421 ml/min/1 .73 m2 .
RESULTS	The study is expected to report in 2015 .
CONCLUSIONS	EMPA-REG OUTCOME will determine the CV safety of empagliflozin in a cohort of patients with type 2 diabetes and high CV risk , with the potential to show cardioprotection .
BACKGROUND	Clinicaltrials.gov NCT01131676 .

###24338597
OBJECTIVE	The clinical effects of osteoporosis include pain , fractures , and physical disability , causing a loss of independence and necessitating long-term care .
OBJECTIVE	Whereas the effects of exercise therapy in decreasing body mass index and preventing fractures are well established , there is no consensus on back pain and quality of life in women with osteoporosis .
OBJECTIVE	The aim of this study was to determine the efficacy of a brief course of rehabilitation , comprising group-adapted physical exercises , with regard to back pain , disability , and quality of life in women with postmenopausal osteoporosis who had no evidence of fractures .
METHODS	The enrolled patients were randomized into two groups : the treatment group underwent ten sessions of rehabilitative exercises , and the control group received an instructional booklet with descriptions and figures of exercises that were to be performed at home .
RESULTS	Sixty patients completed the trial and assessments , including a 6-month follow-up .
RESULTS	The treatment was effective versus the control group , significantly improving pain ( Visual Analogue Scale : p < 0.001 at the end of the treatment and at the follow-up ; McGill Pain Questionnaire : p = 0.018 at the follow-up ) , disability ( Oswestry Disability Questionnaire : p < 0.001 at the end and follow-up ) , and quality of life ( Shortened Osteoporosis Quality of Life Questionnaire : p = 0.021 at the end of treatment ; p = 0.005 at follow-up ) .
CONCLUSIONS	Our results suggest that group rehabilitation reduces back pain and improves functional status and quality of life in women with postmenopausal osteoporosis , maintaining these outcomes for 6 months .
CONCLUSIONS	The use of physical exercises might strengthen the habit to training .

###25450124
OBJECTIVE	To assess the role that treatment response plays in a randomized controlled trial of an antidepressant among people with spinal cord injury ( SCI ) diagnosed with major depressive disorder ( MDD ) in explaining quality of life ( QOL ) , assessed both globally as life satisfaction and in terms of physical and mental health-related QOL .
METHODS	Multivariable analyses were conducted , controlling for demographic , neurologic , and participatory factors and perceived functional limitations .
METHODS	Rehabilitation centers .
METHODS	Of the 133 persons who were randomized into the Project to Improve Symptoms and Mood after Spinal Cord Injury randomized controlled trial , 124 participated in this study .
METHODS	All participants were between the ages of 18 and 64 years , at least 1 month post-SCI , met the Diagnostic and Statistical Manual of Mental Disorders , 4th edition , criteria for MDD , and completed the core measures used in this study .
METHODS	Not applicable .
METHODS	The Satisfaction with Life Scale and the physical and mental component summary scores of the Medical Outcomes Study 12-Item Short-Form Health Survey .
RESULTS	Reduction in depressive symptoms over the course of a 12-week trial was predictive of increased QOL , which was measured as life satisfaction and mental well-being , within the context of other explanatory factors .
RESULTS	However , reduction in symptoms did not explain differences in physical well-being among those with MDD .
RESULTS	Perceived functional disability explained all 3 indices of QOL .
CONCLUSIONS	Greater recognition has been given to QOL outcomes as endpoints of clinical trials because these often reflect participants ' reported outcomes .
CONCLUSIONS	Our findings support the association of QOL to the reduction of depression symptoms among trial participants .
CONCLUSIONS	This association differs depending on how QOL is defined and measured , with stronger relations observed with life satisfaction and mental well-being among those diagnosed with MDD .
CONCLUSIONS	The lack of association between depression and physical well-being may be explained by participants ' subjective interpretation of physical well-being after SCI and their expectations and perceptions of improved physical health-related QOL based on the use of assistive technology .
CONCLUSIONS	Consistent with our findings , pain is likely to play a role in decreasing physical QOL among those with incomplete injuries .
CONCLUSIONS	Practicing caution is suggested in using physical well-being as an endpoint in trials among people with SCI .

###24648482
OBJECTIVE	This randomized , double-blind , placebo-controlled trial evaluated intraperitoneal ( IP ) lidocaine administration and intravenous ( IV ) lidocaine infusion for postoperative pain control after laparoscopic cholecystectomy ( LC ) .
METHODS	Patients who underwent LC were randomized to either group IV ( intravenous lidocaine infusion ) , group IP ( intraperitoneal lidocaine administration ) , or group C ( control , IP and IV saline ) .
METHODS	Outcome measures were total postoperative pain severity ( TPPS ) , total fentanyl consumption ( TFC ) , frequency of administering patient-controlled analgesia ( FPB ) , and a pain control satisfaction score ( PCSS ) .
RESULTS	Significantly reduced TPPS , TFC and FPB scores were observed in groups IP ( n = 22 ) and IV ( n = 26 ) compared with controls ( n = 24 ) .
RESULTS	PCSS was higher in groups IP and IV than in controls .
RESULTS	At 2 h postoperation , TPPS was significantly lower in group IP than group IV ; at 0-2 h postoperation , FPB was lower in group IP than group IV .
CONCLUSIONS	The IP administration of lidocaine and IV lidocaine infusion significantly reduced postoperative pain and opioid consumption in LC patients , compared with control infusions .
CONCLUSIONS	For convenience , IV lidocaine could be used for pain reduction following LC ; IP administration places additional burden on the surgeon .

###24571621
BACKGROUND	Many countries have over the last few years incorporated mental health assertive interventions in an attempt to address the repercussions of deinstitutionalization .
BACKGROUND	Recent publications have failed to duplicate the positive outcomes reported initially which has cast doubt on the future of these interventions .
BACKGROUND	We previously reported on 29 patients from a developing country who completed 12 months in an assertive intervention which was a modified version of the international assertive community treatment model .
BACKGROUND	We demonstrated reduction in readmission rates as well as improvements in social functioning compared to patients from the control group .
BACKGROUND	The obvious question was , however , if these outcomes could be sustained for longer periods of time .
BACKGROUND	This study aims to determine if modified assertive interventions in an under-resourced setting can successfully maintain reductions in hospitalizations .
METHODS	Patients suffering from schizophrenia who met a modified version of Weidens ' high frequency criteria were randomized into two groups .
METHODS	One group received a modified assertive intervention based on the international assertive community treatment model .
METHODS	The other group received standard care according to the model of service delivery in this region .
METHODS	Data was collected after 36 months , comparing readmissions and days spent in hospital .
RESULTS	The results demonstrated significant differences between the groups .
RESULTS	Patients in the intervention group had significantly less readmissions ( p = 0.007 ) and spent less days in hospital compared to the patients in the control group ( p = 0.013 ) .
CONCLUSIONS	Modified assertive interventions may be successful in reducing readmissions and days spent in hospital in developing countries where standard care services are less comprehensive .
CONCLUSIONS	These interventions can be tailored in such a way to meet service needs and still remain affordable and feasible within the context of an under-resourced setting .

###24565238
OBJECTIVE	Bupivacaine is a first choice for regional anesthesia considering its effectiveness , long duration and less motor blockade .
OBJECTIVE	Bupivacaine ( S75-R25 ) is a mixture of optical isomers containing 75 % levobupivacaine ( S - ) and 25 % dextrobupivacaine ( R + ) created by a Brazilian pharmaceutical company .
OBJECTIVE	This investigation compared cardiac safety and efficacy of bupivacaine S75-R25 with vasoconstrictor and ropivacaine for brachial plexus blockade .
METHODS	Patients were randomized to receive brachial plexus anesthesia with either bupivacaine S75-R25 with epinephrine 1:200,000 ( bupi ) or ropivacaine ( ropi ) , both at 0.50 % , in 30 mL solution .
METHODS	We registered a continuous Holter ECG throughout the procedure , as well as the Lovett scale of force in addition to monitoring ( heart rate , pulse oximetry and non-invasive blood pressure ) .
METHODS	The incidence of adverse events was compared with the chi-square or Fisher test .
RESULTS	We allocated forty-four patients into two groups .
RESULTS	They did not show any difference related to age , weight or height , gender , as well as for surgical duration .
RESULTS	Supraventricular arrhythmias were not different before or after the plexus blockade , independent of the local anesthetic chosen .
RESULTS	Loss of sensitivity was faster for the bupivacaine group ( 23.1 11.7 min ) compared to the ropivacaine one ( 26.8 11.5 min ) , though not significant ( p = 0.205 , Student t ) .
RESULTS	There was a reduction in the cardiac rate , observed during the twenty-four-hour Holter monitoring .
CONCLUSIONS	This study showed similar efficacy between bupivacaine S75-R25 for brachial plexus blockade and ropivacaine , with similar incidences of supraventricular arrhythmias .

###24262719
OBJECTIVE	The purpose of this study was to compare breastfeeding duration in mothers after delivery who were assigned randomly to a behavioral educational intervention vs enhanced usual care .
METHODS	We conducted a randomized trial .
METHODS	Self-identified black and Latina mothers early after delivery were assigned randomly to receive a behavioral educational intervention or enhanced usual care .
METHODS	The 2-step intervention aimed to prepare and educate mothers about postpartum symptoms and experiences ( including tips on breastfeeding and breast/nipple pain ) and to bolster social support and self-management skills .
METHODS	Enhanced usual care participants received a list of community resources and received a 2-week control call .
METHODS	Intention-to-treat analyses examined breastfeeding duration ( measured in weeks ) for up to 6 months of observation .
METHODS	This study was registered with clinicaltrial.gov ( NCT01312883 ) .
RESULTS	Five hundred forty mothers were assigned randomly to the intervention ( n = 270 ) vs control subjects ( n = 270 ) .
RESULTS	Mean age was 28 years ( range , 18-46 years ) ; 62 % of the women were Latina , and 38 % were black .
RESULTS	Baseline sociodemographic , clinical , psychosocial , and breastfeeding characteristics were similar among intervention vs control subjects .
RESULTS	Mothers in the intervention arm breastfed for a longer duration than did the control subjects ( median , 12.0 vs 6.5 weeks , respectively ; P = .02 ) Mothers in the intervention arm were less likely to quit breastfeeding over the first 6 months after delivery ( hazard ratio , 0.79 ; 95 % confidence interval , 0.65-0 .97 ) .
CONCLUSIONS	A behavioral educational intervention increased breastfeeding duration among low-income , self-identified black and Latina mothers during the 6-month postpartum period .

###24441084
BACKGROUND	Providing adequate nutritional support to promote optimal postnatal growth for very low birth weight ( VLBW ) infants has been a difficult problem to surmount in the NICU .
BACKGROUND	During the past 4 decades , improvements in neonatal critical care have made it possible for more VLBW infants to survive to discharge from NICUs .
BACKGROUND	The NICHD Neonatal Network reported that while intrauterine growth restriction was present in 22 % of VLBW infants at birth , 91 % demonstrated postnatal growth restriction by 36 weeks post menstrual age .
BACKGROUND	The persistence of this nearly universal growth deficit is associated with the inadequacy of protein and energy intake , which may account for 45-50 % of the postnatal growth restriction .
OBJECTIVE	The purpose of this study was to assess whether increasing enteral intake , using supplemental protein , would improve postnatal growth for VLBW infants .
METHODS	Randomized clinical trial .
METHODS	Sixty-four infants were enrolled ( 34 in control group with 15 infants < 1000 g , and 30 in intervention group with 13 infants < 1000 g ) .
RESULTS	There were no sustained statistical differences between weekly measurements of weight , length , head circumference , and skinfold thickness between groups .
RESULTS	There were no significant differences between laboratory results except blood urea nitrogen at time of peak protein intake for intervention group .
CONCLUSIONS	Supplemental enteral protein had minimal to no effect on postnatal weight , length , head circumference , body mass , or length of stay .
CONCLUSIONS	It may be most important to provide consistent sustained nutritional support with protein from birth to reduce postnatal growth restriction , especially for those infants < 1000 g at birth .

###24746599
BACKGROUND	Radiation absorbed by interventional cardiologists is a frequently under-evaluated important issue .
BACKGROUND	Aim is to compare radiation dose absorbed by interventional cardiologists during percutaneous coronary procedures for acute coronary syndromes comparing transradial and transfemoral access .
METHODS	The randomized multicentre MATRIX ( Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX ) trial has been designed to compare the clinical outcome of patients with acute coronary syndromes treated invasively according to the access site ( transfemoral vs. transradial ) and to the anticoagulant therapy ( bivalirudin vs. heparin ) .
METHODS	Selected experienced interventional cardiologists involved in this study have been equipped with dedicated thermoluminescent dosimeters to evaluate the radiation dose absorbed during transfemoral or right transradial or left transradial access .
METHODS	For each access we evaluate the radiation dose absorbed at wrist , at thorax and at eye level .
METHODS	Consequently the operator is equipped with three sets ( transfemoral , right transradial or left transradial access ) of three different dosimeters ( wrist , thorax and eye dosimeter ) .
METHODS	Primary end-point of the study is the procedural radiation dose absorbed by operators at thorax .
METHODS	An important secondary end-point is the procedural radiation dose absorbed by operators comparing the right or left radial approach .
METHODS	Patient randomization is performed according to the MATRIX protocol for the femoral or radial approach .
METHODS	A further randomization for the radial approach is performed to compare right and left transradial access .
CONCLUSIONS	The RAD-MATRIX study will probably consent to clarify the radiation issue for interventional cardiologist comparing transradial and transfemoral access in the setting of acute coronary syndromes .

###25079477
OBJECTIVE	Gastroesophageal reflux ( GER ) is a frequently occurring condition in infants capable of causing distressing symptoms .
OBJECTIVE	The aim of our study is to evaluate the efficacy of Mg alginate plus simethicone ( Gastrotuss Baby , DMG Italia SRL , Pomezia , Italy ) , compared with rice-starch-thickened formula or with reassurance alone , in the treatment of GER in infants .
METHODS	The present randomized controlled trial was conducted in full-term infants affected by symptoms suggestive of GER , evaluated through a validated questionnaire ( Infant Gastroesophageal Reflux Questionnaire Revised ) .
METHODS	The patients were randomized into 3 groups according to treatment ( group A : Mg alginate plus simethicone ; group B : thickened formula ; group C : reassurance with lifestyle changes ) .
METHODS	Evaluation of symptom scores was performed after 1 month ( T1 ) and 2 months ( T2 ) .
RESULTS	A total of 64 ( 85.3 % ) of 75 enrolled infants ( median age 5 months ; range 1-10 ) concluded the study .
RESULTS	After 1 month of treatment ( T1 ) , infants treated with Mg alginate plus simethicone showed a statistically significant improvement in symptoms compared with the thickened formula and reassurance ( P < 0.03 , < 0.0001 , respectively ) .
RESULTS	At the end of the study , all 3 groups of patients showed a significant reduction in symptom scores ( P < 0.002 , < 0.038 , < 0.03 , respectively ) .
RESULTS	Median symptom score values were more significantly reduced in group A than in group B and in group C ( group A vs group B P < 0.002 ; group A vs group C P < 0.0001 ; group B vs group C P < 0.001 ) .
CONCLUSIONS	Mg alginate plus simethicone seems to be more efficacious on GER symptom scores than thickened formula and reassurance with lifestyle changes alone .

###25661122
OBJECTIVE	To evaluate the safety and effectiveness of the Trulign toric intraocular lens ( IOL ) in adults with cataract .
METHODS	Eight private practices in the United States and 1 in Canada .
METHODS	Prospective randomized single-masked multicenter study .
METHODS	A toric IOL ( 1.25 D , 2.00 D , or 2.75 D , determined by a toric calculator ) was implanted in eligible patients with age-related cataract requiring a 16.00 to 27.00 diopter ( D ) spherical IOL power and with a predicted postoperative astigmatism of 0.83 to 2.50 D. Eyes within the lowest cylinder range ( predicted postoperative astigmatism 0.83 to 1.32 D ) were randomized in a 1:1 ratio between the 1.25 D toric IOL group and the nontoric accommodating IOL ( Crystalens ) control group .
RESULTS	The toric 1.25 D group had a statistically significantly greater percentage reduction in absolute cylinder ( P < .001 ) and uncorrected distance visual acuity ( P = .002 ) than the control group at the 120 - to 180-day visit .
RESULTS	The mean monocular uncorrected vision at distance , intermediate , and near was 20/25 , 20/22 , and 20/39 , respectively , with the 1.25 D , 2.00 D , and 2.75 D toric IOLs in aggregate ( toric group ) .
RESULTS	In addition , 96.1 % of patients ( 123/128 ) had 5.0 degrees or less absolute IOL rotation postoperatively .
RESULTS	Regarding safety , the endpoints for preservation of corrected visual acuity and the incidence of complications and adverse events were met .
CONCLUSIONS	The toric IOL was safe and effective in reducing the effects of preoperative corneal astigmatism and provided excellent uncorrected distance and intermediate vision and functional near vision .
BACKGROUND	Dr. Pepose is a consultant to Bausch & Lomb and was medical monitor of this study .
BACKGROUND	Drs. Buckhurst , Whitman , Feinerman , Hovanesian , Davies , Labor , and Carter are consultants to Bausch & Lomb .
BACKGROUND	At the time of the study , Drs. Hayashida , and Khodai were employees of Bausch & Lomb .
BACKGROUND	Drs. Colvard and Mittleman have financial or proprietary interest in any material or method mentioned .

###24456143
OBJECTIVE	The purpose of this study was to investigate the effect of low-level laser therapy ( LLLT ) before and after exercise on quadriceps muscle performance , and to evaluate the changes in serum lactate and creatine kinase ( CK ) levels .
METHODS	The study was randomized , double blind , and placebo controlled .
METHODS	A sample of 27 healthy volunteers ( male soccer players ) were divided into three groups : placebo , pre-fatigue laser , and post-fatigue laser .
METHODS	The experiment was performed in two sessions , with a 1 week interval between them .
METHODS	Subjects performed two sessions of stretching followed by blood collection ( measurement of lactate and CK ) at baseline and after fatigue of the quadriceps by leg extension .
METHODS	LLLT was applied to the femoral quadriceps muscle using an infrared laser device ( 830 nm ) , 0.0028 cm ( 2 ) beam area , six 60 mW diodes , energy of 0.6 J per diode ( total energy to each limb 25.2 J ( 50.4 J total ) , energy density 214.28 J/cm ( 2 ) , 21.42 W/cm ( 2 ) power density , 70 sec per leg .
METHODS	We measured the time to fatigue and number and maximum load ( RM ) of repetitions tolerated .
METHODS	Number of repetitions and time until fatigue were primary outcomes , secondary outcomes included serum lactate levels ( measured before and 5 , 10 , and 15 min after exercise ) , and CK levels ( measured before and 5 min after exercise ) .
RESULTS	The number of repetitions ( p = 0.8965 ) , RM ( p = 0.9915 ) , and duration of fatigue ( p = 0.8424 ) were similar among the groups .
RESULTS	Post-fatigue laser treatment significantly decreased the serum lactate concentration relative to placebo treatment ( p < 0.01 ) and also within the group over time ( after 5 min vs. after 10 and 15 min , p < 0.05 both ) .
RESULTS	The CK level was lower in the post-fatigue laser group ( p < 0.01 ) .
CONCLUSIONS	Laser application either before or after fatigue reduced the post-fatigue concentrations of serum lactate and CK .
CONCLUSIONS	The results were more pronounced in the post-fatigue laser group .

###24687830
OBJECTIVE	Liver injury is a serious adverse event leading to permanent discontinuation of lapatinib in affected patients .
OBJECTIVE	This study aimed to validate previously associated major histocompatibility complex ( MHC ) variants as predictors of risk of liver injury by using a large , randomized , placebo-controlled trial of lapatinib in human epidermal growth factor receptor 2-positive , early-stage breast cancer ( Tykerb Evaluation After Chemotherapy [ TEACH ] : Lapatinib Versus Placebo In Women With Early-Stage Breast Cancer ) .
METHODS	The frequency of ALT elevation cases was compared among four MHC variants in 1,194 patients randomly assigned to lapatinib .
METHODS	Cumulative ALT elevation time courses during treatment were also compared between carriers and noncarriers of specified MHC variants .
RESULTS	In lapatinib-treated patients , there was a significant difference in ALT case incidence between HLA carriers and noncarriers .
RESULTS	The highly correlated alleles HLA-DRB1 * 07:01 and HLA-DQA1 * 02:01 ( study frequency , 22.4 % ) were associated with ALT elevation ( odds ratio , 14 ) between cases ( n = 37 ) and controls ( n = 1,071 ) .
RESULTS	These associations strengthened at higher ALT elevation thresholds and in Hy 's Law cases .
RESULTS	In lapatinib-treated patients , the overall risk for National Cancer Institute-Common Terminology Criteria for Adverse Events grade 3 ALT elevation ( > 5 upper limit of normal ) was 2.1 % ; HLA allele carriers had an increased risk of 7.7 % ; in noncarriers , risk was reduced to 0.5 % , comparable to ALT elevation for all patients receiving placebo .
RESULTS	The increase in ALT case incidence in the lapatinib arm showed no evidence of plateau during 1 year of lapatinib treatment .
CONCLUSIONS	These results validate HLA-DRB1 * 07:01 allele carriage as a predictor of increased risk of lapatinib-induced liver injury and implicate an immune pathology .
CONCLUSIONS	The HLA association could support clinical management of patients experiencing hepatotoxicity during lapatinib treatment .

###24811601
OBJECTIVE	To explore the safety and efficacy of PRT-201 applied to the outflow vein of a newly created arteriovenous graft ( AVG ) .
METHODS	Randomized , double-blind , placebo-controlled , single-dose escalation study of PRT-201 ( 0.01 to 9 mg ) applied to the graft-vein anastomosis and adjacent outflow vein immediately after AVG placement .
METHODS	The primary outcome measure was safety .
METHODS	The efficacy measures were intraoperative increases in outflow vein diameter and blood flow rate , primary unassisted patency , and secondary patency by dose groups ( placebo , low , medium , high and All PRT-201 ) .
RESULTS	A total of 89 patients were treated ( 28 placebo and 61 PRT-201 ) .
RESULTS	There were no significant differences in the proportion of placebo and PRT-201 patients reporting adverse events .
RESULTS	Intraoperative outflow vein diameter increased 5 % ( p = 0.14 ) in the placebo group compared with 13 % ( p = 0.01 ) , 15 % ( p = 0.07 ) and 12 % ( p < 0.001 ) , in the low , medium and high groups , respectively .
RESULTS	The comparison between the high and placebo groups was marginally statistically significant ( p = 0.06 ) .
RESULTS	The intraoperative blood flow did not change in the placebo group , and increased in the low , medium and high groups by 19 % ( p = 0.34 ) , 36 % ( p = 0.09 ) and 46 % ( p = 0.02 ) , respectively .
RESULTS	The low group had the longest primary unassisted and secondary patency and the fewest procedures to restore or maintain patency ; however , the differences between groups were not statistically significant .
CONCLUSIONS	PRT-201 was well tolerated and increased AVG intraoperative outflow vein diameter and blood flow .
CONCLUSIONS	Low dose tended to increase secondary patency and decrease the rate of procedures to restore or maintain patency .
CONCLUSIONS	Larger studies with these doses will be necessary to confirm these results .

###24420499
OBJECTIVE	The blood glucose target range and optimal method to reach this range remain a matter of debate in the intensive care unit ( ICU ) .
OBJECTIVE	A computer decision support system ( CDSS ) might improve the outcome of ICU patients through facilitation of a tighter blood glucose control .
METHODS	We conducted a multi-center randomized trial in 34 French ICU .
METHODS	Adult patients expected to require treatment in the ICU for at least 3 days were randomly assigned without blinding to undergo tight computerized glucose control with the CDSS ( TGC ) or conventional glucose control ( CGC ) , with blood glucose targets of 4.4-6 .1 and < 10.0 mmol/L , respectively .
METHODS	The primary outcome was all-cause death within 90 days after ICU admission .
RESULTS	Of the 2,684 patients who underwent randomization to the TGC and CGC treatment groups , primary outcome was available for 1,335 and 1,311 patients , respectively .
RESULTS	The baseline characteristics of these treatment groups were similar in terms of age ( 61 16 years ) , SAPS II ( 51 19 ) , percentage of surgical admissions ( 40.0 % ) and proportion of diabetic patients ( 20.3 % ) .
RESULTS	A total of 431 ( 32.3 % ) patients in the TGC group and 447 ( 34.1 % ) in the CGC group had died by day 90 ( odds ratio for death in the TGC 0.92 ; 95 % confidence interval 0.78-1 .78 ; p = 0.32 ) .
RESULTS	Severe hypoglycemia ( < 2.2 mmol/L ) occurred in 174 of 1,317 patients ( 13.2 % ) in the TGC group and 79 of 1,284 patients ( 6.2 % ) in the CGC group ( p < 0.001 ) .
CONCLUSIONS	Tight computerized glucose control with the CDSS did not significantly change 90-day mortality and was associated with more frequent severe hypoglycemia episodes in comparison with conventional glucose control .

###24282229
OBJECTIVE	We evaluated the effect of ginkgo biloba extract on visual field defect and contrast sensitivity in a Chinese cohort with normal tension glaucoma .
METHODS	In this prospective , randomized , placebo-controlled crossover study , patients newly diagnosed with normal tension glaucoma , either in a tertiary glaucoma clinic ( n = 5 ) or in a cohort undergoing routine general physical examinations in a primary care clinic ( n = 30 ) , underwent two 4-week phases of treatment , separated by a washout period of 8 weeks .
METHODS	Randomization determined whether ginkgo biloba extract ( 40 mg , 3 times per day ) or placebo ( identical-appearing tablets ) was received first .
METHODS	Primary outcomes were change in contrast sensitivity and mean deviation on 24-2 SITA standard visual field testing , while secondary outcomes included IOP and self-reported adverse events .
RESULTS	A total of 35 patients with mean age 63.7 ( 6.5 ) years were randomized to the ginkgo biloba extract-placebo ( n = 18 ) or the placebo-ginkgo biloba extract ( n = 17 ) sequence .
RESULTS	A total of 28 patients ( 80.0 % , 14 in each group ) who completed testing did not differ at baseline in age , sex , visual field mean deviation , contrast sensitivity , IOP , or blood pressure .
RESULTS	Changes in visual field and contrast sensitivity did not differ by treatment received or sequence ( P > 0.2 for all ) .
RESULTS	Power to have detected a difference in mean defect as large as previously reported was 80 % .
CONCLUSIONS	In contrast to some previous reports , ginkgo biloba extract treatment had no effect on mean defect or contrast sensitivity in this group of normal tension glaucoma patients .
CONCLUSIONS	( http://www.chictr.org number , ChiCTR-TRC-08000724 ) .

###24580752
BACKGROUND	In vivo studies showing the effects of biologic healing-promoting factors on tendon-to-bone healing after rotator cuff repair have focused only on biologic healing-promoting factors and have not taken into consideration the effect of the carrier vehicle .
BACKGROUND	Moreover , most studies have evaluated the healing process using different carrier vehicles , each of which may have specific effects on tendon healing .
BACKGROUND	This may explain the large variability seen in outcomes in research studies .
BACKGROUND	In this study , we investigated the effects of Poloxamer 407 as a carrier vehicle on rotator cuff healing at the repair site and compared it with those of a collagen sponge , which is a commonly used carrier vehicle .
METHODS	Fifty-seven adult male Sprague-Dawley rats underwent detachment and immediate repair of the bilateral supraspinatus tendons .
METHODS	Rats were randomly assigned to three groups : repair only , repair with collagen sponge , and repair with Poloxamer 407 .
METHODS	The repairs were evaluated at 1 , 2 , 4 , and 8 weeks after surgery with histological analysis and biomechanical testing .
RESULTS	At 4 weeks , more cellular organization , a greater number of collagen fibers , and increased maturity of collagen fibers were observed in the repair with Poloxamer 407 group than in the other groups .
RESULTS	The repair with collagen sponge group had delayed development and collagen fiber maturation .
RESULTS	Significant differences in the biomechanical properties were found between groups at 4 weeks .
RESULTS	Stiffness in the case of the repair with Poloxamer 407 group was significantly higher than that in the repair with collagen sponge group .
RESULTS	The modulus was significantly lower in the repair with collagen sponge group than in the repair only group .
RESULTS	However , the use of Poloxamer 407 versus the collagen sponge did not significantly affect the biomechanical properties of the repaired tendons at 8 weeks .
CONCLUSIONS	Carrier vehicles may have differing effects at the early stages of rotator cuff healing .
CONCLUSIONS	The use of Poloxamer 407 as a carrier vehicle may be useful for promoting the early stages of healing and for maintaining the initial biomechanical properties of the repaired rotator cuff tendon .

###25483366
BACKGROUND	Low vitamin D serum levels have been associated with unfavourable lipid profile and poorer response to atorvastatin .
BACKGROUND	Aims of this study were to test the effects of 25-hydroxyvitamin D3 ( calcifediol ) compared to parental vitamin D3 ( cholecalciferol ) supplementation on modifications of plasma 25 ( OH ) D levels and lipid profile .
METHODS	Fifty-seven postmenopausal women ( aged 59.03 6.73 years ) who were at low risk of fracture and with basal plasma 25 ( OH ) D < 30 ng/mL were included if they were on atorvastatin treatment prescribed as appropriate .
METHODS	Recruited women were randomized to receive oral calcifediol or cholecalciferol , both at a dose of 140 g according to a weekly regimen .
RESULTS	At baseline , 25 ( OH ) D was negatively associated with BMI ( r = -0.37 ; P = 0.004 ) , total cholesterol ( r = -0.31 ; P = 0.01 ) and LDL-C ( r = -0.32 ; P = 0.02 ) .
RESULTS	After 24 weeks , 25 ( OH ) D increased significantly in both groups ( P < 0.001 ) , although higher levels were obtained with calcifediol as compared with cholecalciferol ( P < 0.001 ) .
RESULTS	Only in the calcifediol group , a significant reduction of LDL-C ( P = 0.01 ) and an increase of HDL-C ( P = 0.02 ) were obtained , even after adjustment for age , and baseline BMI , 25 ( OH ) D and lipid levels ( P < 0.05 ) .
RESULTS	The percentage changes in 25 ( OH ) D levels were associated with the variations of LDL-C ( r = -0.44 ; P = 0.01 ) and HDL-C levels ( r = 0.30 ; P = 0.10 ) .
CONCLUSIONS	Calcifediol administration in osteopenic and dyslipidemic postmenopausal women with low 25 ( OH ) D improves lipid profile when added to an ongoing atorvastatin treatment .

###25372582
OBJECTIVE	It is believed that gastric pH interferes in levothyroxine absorption .
OBJECTIVE	Omeprazole , which acts by blocking the secretion of gastric acid , might interfere in hypothyroidism control in patients using levothyroxine and this effect could be dose dependent .
OBJECTIVE	The present study aimed to investigate this possibility .
METHODS	Twenty-one patients with primary hypothyroidism who had been using a stabilized levothyroxine dosage for at least one year were selected and randomly assigned to take omeprazole at the dosage of 40 mg or 20 mg per day .
METHODS	The mean levels of thyroid-stimulating hormone ( TSH ) before and 3 months after omeprazole usage were compared in the entire sample and in each group .
RESULTS	Ten patients concluded the entire treatment protocol in the 20 mg group and nine patients in the 40 mg group .
RESULTS	There was no significant difference in TSH levels before and 3 months after omeprazole treatment in the entire patient sample ( median levels : 2.28 vs. 2.30 mU/L , respectively : p = 0.56 ) .
RESULTS	Analysis of each subgroup ( 20 and 40 mg ) showed no significant variation in TSH levels before and 3 months after omeprazole treatment ( median levels : 2.24 vs. 2.42 mU/L , p = 0.62 , and 2.28 vs. 2.30 mU/L , p = 0.82 , respectively ) .
RESULTS	No significant difference in the absolute ( p = 0.93 ) or relative ( p = 0.87 ) delta were observed between the two subgroups .
CONCLUSIONS	Omeprazole in the dosage of 20 or 40 mg/day does not interfere in a clinically relevant manner in the treatment of patients with hypothyroidism that was previously under control .

###25804580
OBJECTIVE	To compare the 6-month results of accelerated and standard collagen crosslinking ( CXL ) treatment of progressive keratoconus .
METHODS	Noor Eye Hospital , Tehran , Iran .
METHODS	Prospective randomized clinical trial .
METHODS	Two groups of eyes ( intervention and control ) received corneal collagen crosslinking ( CXL ) treatment .
METHODS	The intervention group received accelerated CXL ( 18 mW/cm ( 2 ) , 5 minutes ) , and the control group received standard CXL ( 3 mW/cm ( 2 ) , 30 minutes ) .
METHODS	The eyes were evaluated for changes in the visual indices , refraction , and topography preoperatively and 1 , 3 , and 6 months postoperatively and regarding corneal rigidity indices and the endothelial cell count ( ECC ) preoperatively and at 6 months .
RESULTS	The study evaluated 62 eyes ( 31 patient ) in 2 groups .
RESULTS	The mean changes in uncorrected ( P = .733 ) and corrected ( P = .646 ) distance visual acuities and manifest refraction spherical equivalent ( P = .598 ) did not differ statistically significantly between the 2 groups .
RESULTS	The central corneal thickness was higher in the standard group than the accelerated group ( P = .025 ) .
RESULTS	The mean decrease in the maximum keratometry ( K ) ( P = .865 ) and mean K ( P = .974 ) and the mean changes in the asphericity ( P = .272 ) were not statistically significantly different between the 2 groups .
RESULTS	The mean changes in corneal hysteresis ( CH ) ( P = .548 ) and the corneal resistance factor ( CRF ) ( P = 1.000 ) , CH-CRF ( P = .282 ) , and the area under the peak 2 ( P = .260 ) were similar in both groups .
RESULTS	The mean decrease in the ECC was not statistically significantly different between the 2 groups ( P = .218 ) .
CONCLUSIONS	Based on 6-month results , accelerated and standard corneal CXL arrested the progression of keratoconus similarly .
BACKGROUND	No author has a financial or proprietary interest in any material or method mentioned .

###24960147
OBJECTIVE	Assess the efficacy and safety of etoricoxib 120mg compared with ibuprofen 600mg qid in the treatment of moderate to severe primary dysmenorrhea in Chinese women .
METHODS	This multicenter , double-blind , two-period , cross-over study randomized healthy , Chinese women 18 years of age to etoricoxib 120mg qd or ibuprofen up to 2400mg ( 600mg qid ) upon onset of moderate or severe primary dysmenorrhea symptoms during two menstrual cycles .
METHODS	The primary efficacy endpoint was Total Pain Relief score over the first 6 hours ( TOPAR6 ) .
METHODS	Secondary endpoints included Sum of Pain Intensity Difference scores over the first 6 hours ( SPID6 ) and Patient 's Global Evaluation ( GLOBAL ) of pain at 6 and 24 hours post initial dose .
METHODS	The primary hypothesis was that etoricoxib would be non-inferior to ibuprofen .
METHODS	Adverse experiences ( AE ) were monitored and evaluated .
RESULTS	A total of 139 patients were included in this study .
RESULTS	Difference in least squares ( LS ) mean ( 95 % CI ) TOPAR6 score for etoricoxib vs. ibuprofen was 0.89 ( 0.03 , 1.76 ) ( p = 0.043 ) .
RESULTS	LS mean ( 95 % CI ) difference for etoricoxib vs. ibuprofen SPID6 , GLOBAL6 , and GLOBAL24 were 0.20 ( -1.16 , 1.57 ) ( p = 0.768 ) , 0.26 ( 0.07 , 0.45 ) ( p = 0.007 ) , and 0.36 ( 0.17 , 0.54 ) ( p < 0.001 ) , respectively .
RESULTS	AEs were rare , with the following AEs determined to be drug-related : hypomenorrhea ( two patients on etoricoxib ) and allergic dermatitis ( one patient on ibuprofen ) .
RESULTS	Limitations of the study design include a sample size that is not adequate for evaluation of rare adverse effects , an evaluation period that was limited to 24 hours , and inconsistent frequency of active treatment doses between etoricoxib ( once daily ) and ibuprofen ( up to four times daily ) .
CONCLUSIONS	The primary objective of the study was met , demonstrating that etoricoxib 120mg qd was non-inferior to ibuprofen 600mg qid ; further , etoricoxib was statistically superior to ibuprofen 600mg qid according to the primary endpoint ( TOPAR6 ) and patient global assessments of study medication .
CONCLUSIONS	Etoricoxib and ibuprofen were generally well tolerated .

###24318038
OBJECTIVE	The purpose of the study is to evaluate the effects of creatine supplementation on homocysteine ( Hcy ) plasma levels after acute exercise in humans .
METHODS	Twenty-three young ( under-20 ) soccer players were divided into 2 groups : creatine ( Cr ) - and placebo ( Pla ) - supplemented groups .
METHODS	The supplementation was performed in double-blind controlled manner using creatine or placebo tablets with 0.3 g/kg during 7 days .
METHODS	Before and after 7 days of supplementation , the athletes performed an acute high-intensity sprint exercise ( two consecutive running-based anaerobic sprint test protocol consisted in 6 35 m sprint with 10 s between them ) .
METHODS	Blood samples were collected before and after 7 days of supplementation as well as 0 and 1 h after exercise protocol .
RESULTS	Homocysteine concentration significant increased ( P < 0.05 ) 1 h after acute exercise ( 18 % ) .
RESULTS	Acute exercise also decreased red blood cell S-adenosylmethionine ( SAM ) 30 % with no changes in SAM/SAH ratio .
RESULTS	Seven days of creatine supplementation were able to increase ( P < 0.05 ) plasma creatine concentration ( Pla 130.1 21.7 vs Cr 1,557.2 220.3 mol/L ) as well as decrease ( P < 0.05 ) plasma guanidinoacetic acid ( 33 % ) .
RESULTS	Controversially , creatine supplementation did not change Hcy plasma level after 7-day supplementation ( Pla 6.9 0.2 vs Cr 7.2 0.2 mol/L ) or after acute exercise ( Pla 8.2 0.3 vs Cr 8.4 0.3 mol/L ) .
RESULTS	No changes in plasma vitamin B12 and folate as well as cysteine and methionine were found .
CONCLUSIONS	Seven days of creatine supplementation does not avoid increased plasma Hcy induced by acute sprint exercise in humans .

###24298762
OBJECTIVE	To evaluate the clinical efficacy of asthma at acute attack stage treated with `` Shao 's five needling therapy '' .
METHODS	The randomized controlled method was applied to divide 210 cases into an observation group and a control group , 105 cases in each one .
METHODS	In the observation group , `` Shao 's five needling therapy '' [ Feishu ( BL 13 ) , Dazhui ( GV 14 ) , Fengmen ( BL 12 ) ] and the combined therapy were adopted , including oxygen uptake , aerosol inhalation and oral administration of prednisone .
METHODS	In the control group , the oral administration of theophylline sustained release tablet and the combined therapy were applied .
METHODS	The treatment was continued for 7 days .
METHODS	The clinical symptoms and physical signs such as wheezing , cough , expectoration , chest stuffiness , wheezing rale and shortness of breath , as well as lung function indices such as forced expiratory volume one second ( FEV1 ) and peak expiratory flow ( PEF ) were observed before and after treatment in the two groups .
METHODS	In the observation group , 69 cases were cured clinically , 20 cases effective remarkably , 7 cases effective and 0 case failed .
METHODS	In the control group , 49 cases were cured clinically , 31 cases effective remarkably , 15 cases effective and 0 case failed .
METHODS	The difference in the efficacy was significant in comparison of the two groups ( P < 0.05 ) .
METHODS	The therapeutic effect in the observation group was better than that in the control group .
METHODS	The total score of the symptoms and physical signs , FEV1 and PEF after treatment were all improved significantly in the two groups ( all P < 0.01 ) .
METHODS	And the results in the observation group were better than those in the control group ( all P < 0.01 ) .
CONCLUSIONS	`` Shao 's five needling therapy '' achieves the significant efficacy on asthma at acute attack stage .
CONCLUSIONS	It significantly relieves the symptoms and physical signs of the patients and improves lung functions .
CONCLUSIONS	The effect is better than that of theophylline sustained release tablet .

###25146491
BACKGROUND	In a double-blind , randomized , placebo-controlled birth cohort , we have recently shown a beneficial effect of Lactobacillus rhamnosus HN001 ( HN001 ) for the prevention of eczema in children through to 6years of age but no effect of Bifidobacterium animalis subsp lactis HN019 ( HN019 ) .
OBJECTIVE	Among this cohort of children , we aim to investigate whether these probiotics could modify the expression of genetic predisposition to eczema conferred by genetic variation in susceptibility genes .
METHODS	Thirty-three eczema susceptibility SNPs ( in eleven genes ) were genotyped in 331 children of European ancestry .
RESULTS	Children who carried a genetic variant that put them at a high risk of developing eczema were less likely to develop eczema if they had been randomized to the HN001 intervention group compared to those in the placebo group .
RESULTS	HN019 was also able to protect against the effects of some SNPs .
RESULTS	As well as modifying genetic susceptibility to childhood eczema , HN001 was also found to modify genetic susceptibility to eczema severity and atopy risk .
CONCLUSIONS	This is the first study to show an effect of a probiotic on reducing eczema risk amongst those with particular eczema-associated genotypes .
CONCLUSIONS	Our findings suggest that Lactobacillus rhamnosus HN001 may be particularly effective in preventing eczema in children with specific high-risk genotypes .

###25373872
BACKGROUND	The aim of this cadaveric study was to compare a polyaxial ( NCB , Zimmer ) to a fixed-angle monoaxial locking plate ( PERILOC , Smith & Nephew ) in comminuted fractures of the distal femur regarding stability of the construct .
BACKGROUND	Up to date there is no published biomechanical data concerning polyaxial plating in cadaveric distal femurs .
METHODS	Fourteen formalin fixed femora were scanned by dual-energy x-ray absorptiometry .
METHODS	As fracture model an unstable supracondylar comminuted fracture was simulated .
METHODS	Fractures were pairwise randomly fixed either with a mono - ( group A ) or a polyaxial ( group B ) distal femur plate .
METHODS	The samples were tested in a servohydraulic mechanical testing system starting with an axial loading of 200 N following an increase of 200 N in every step with 500 cycles in every sequence up to a maximum of 2 000 N.
METHODS	The end points were implant failure or relevant loss of reduction .
METHODS	Data records included for each specimen time , number of cycles , axial load and axial displacement .
METHODS	Statistical analysis was performed using the exact Wilcoxon signed rank test .
RESULTS	The mean donor age at the time of death was 75 years .
RESULTS	The bone mass density ( BMD ) of the femurs in both groups was comparable and showed no statistically significant differences .
RESULTS	Five bones failed before reaching the maximum applied force of 2000 N. Distribution curves of all samples in both groups , showing the plastic deformation in relation to the axial force , showed no statistically significant differences .
CONCLUSIONS	Operative stabilization of distal femur fractures can be successfully and equally well achieved using either a monoaxial or a polyaxial locking plate .
CONCLUSIONS	Polyaxial screw fixation may have advantages if intramedullary implants are present .

###26002111
BACKGROUND	The international standard of care for women with suspected advanced ovarian cancer is surgical debulking followed by platinum-based chemotherapy .
BACKGROUND	We aimed to establish whether use of platinum-based primary chemotherapy followed by delayed surgery was an effective and safe alternative treatment regimen .
METHODS	In this phase 3 , non-inferiority , randomised , controlled trial ( CHORUS ) undertaken in 87 hospitals in the UK and New Zealand , we enrolled women with suspected stage III or IV ovarian cancer .
METHODS	We randomly assigned women ( 1:1 ) either to undergo primary surgery followed by six cycles of chemotherapy , or to three cycles of primary chemotherapy , then surgery , followed by three more cycles of completion chemotherapy .
METHODS	Each 3-week cycle consisted of carboplatin AUC5 or AUC6 plus paclitaxel 175 mg/m ( 2 ) , or an alternative carboplatin combination regimen , or carboplatin monotherapy .
METHODS	We did the random assignment by use of a minimisation method with a random element , and stratified participants according to the randomising centre , largest radiological tumour size , clinical stage , and prespecified chemotherapy regimen .
METHODS	Patients and investigators were not masked to group assignment .
METHODS	The primary outcome measure was overall survival .
METHODS	Primary analyses were done in the intention-to-treat population .
METHODS	To establish non-inferiority , the upper bound of a one-sided 90 % CI for the hazard ratio ( HR ) had to be less than 1.18 .
METHODS	This trial is registered , number ISRCTN74802813 , and is closed to new participants .
RESULTS	Between March 1 , 2004 , and Aug 30 , 2010 , we randomly assigned 552 women to treatment .
RESULTS	Of the 550 women who were eligible , 276 were assigned to primary surgery and 274 to primary chemotherapy .
RESULTS	All were included in the intention-to-treat analysis ; 251 assigned to primary surgery and 253 to primary chemotherapy were included in the per-protocol analysis .
RESULTS	As of May 31 , 2014 , 451 deaths had occurred : 231 in the primary-surgery group versus 220 in the primary-chemotherapy group .
RESULTS	Median overall survival was 22.6 months in the primary-surgery group versus 24.1 months in primary chemotherapy .
RESULTS	The HR for death was 0.87 in favour of primary chemotherapy , with the upper bound of the one-sided 90 % CI 0.98 ( 95 % CI 0.72-1 .05 ) .
RESULTS	Grade 3 or 4 postoperative adverse events and deaths within 28 days after surgery were more common in the primary-surgery group than in the primary-chemotherapy group ( 60 [ 24 % ] of 252 women vs 30 [ 14 % ] of 209 , p = 0.0007 , and 14 women [ 6 % ] vs 1 woman [ < 1 % ] , p = 0.001 ) .
RESULTS	The most common grade 3 or 4 postoperative adverse event was haemorrhage in both groups ( 8 women [ 3 % ] in the primary-surgery group vs 14 [ 6 % ] in the primary-chemotherapy group ) .
RESULTS	110 ( 49 % ) of 225 women receiving primary surgery and 102 ( 40 % ) of 253 receiving primary chemotherapy had a grade 3 or 4 chemotherapy related toxic effect ( p = 0.0654 ) , mostly uncomplicated neutropenia ( 20 % and 16 % , respectively ) .
RESULTS	One fatal toxic effect , neutropenic sepsis , occurred in the primary-chemotherapy group .
CONCLUSIONS	In women with stage III or IV ovarian cancer , survival with primary chemotherapy is non-inferior to primary surgery .
CONCLUSIONS	In this study population , giving primary chemotherapy before surgery is an acceptable standard of care for women with advanced ovarian cancer .
BACKGROUND	Cancer Research UK and the Royal College of Obstetricians and Gynaecologists .

###25163397
BACKGROUND	Bone metastases from renal cell carcinoma ( RCC ) are a major cause of morbidity .
BACKGROUND	Post hoc analysis has suggested that bone turnover markers can identify patients at risk of skeletal-related events ( SREs ) among those receiving zoledronic acid .
BACKGROUND	This study sought to evaluate the effect on bone metastases of everolimus alone compared with everolimus plus zoledronic acid .
METHODS	Thirty treatment-naive patients with RCC and 1 bone metastases were randomized 1:1 to everolimus ( 10 mg daily ) versus everolimus plus zoledronic acid ( 4 mg intravenously 4-weekly ) .
METHODS	Bone-specific assessments were performed at baseline and at weeks 1 , 4 , 8 , and 12 .
METHODS	Treatment was continued on allocated arm until progression per RECIST 1.1 ( Response Evaluation Criteria in Solid Tumors , version 1.1 ) .
METHODS	The primary outcome measure was urine N-telopeptide ( uNTX ) level , with secondary measures of plasma C-telopeptide ( CTX ) , quality of life ( Functional Assessment of Cancer Therapy-Bone Pain [ FACT-BP ] , Brief Pain Inventory [ BPI ] ) , progression-free survival ( PFS ) , SREs , and safety .
RESULTS	After 12 weeks , reduction in mean uNTX and CTX on everolimus plus zoledronic acid relative to everolimus was 68.4 % ( 95 % CI , 60.1 % -74.9 % ; P < .0001 ) and 76.2 % ( 95 % CI , 67.3 % -82.7 % ; P < .0001 ) , respectively .
RESULTS	There was no evidence of a difference for FACT-BP ( P = .5 ) , but evidence was favorable for BPI Severity ( P = .05 ) and BPI Interference ( P = .06 ) .
RESULTS	Median PFS was 7.5 months ( 95 % CI , 3.4-11 .2 ) on everolimus plus zoledronic acid and 5.4 months ( 95 % CI , 3.2-6 .3 ) on everolimus ( P = .009 ) .
RESULTS	Median time to first SRE was 9.6 months ( 95 % CI , 4.3-15 .5 ) on everolimus plus zoledronic acid and 5.2 months ( 95 % CI , 1.6-8 .2 ) on everolimus ( P = .03 ) .
CONCLUSIONS	In this RCC population , the addition of zoledronic acid to everolimus significantly reduced bone resorption markers and may prolong tumor control .

###24331842
BACKGROUND	Induced hypotension is widely used intraoperatively to reduce blood loss and to improve the surgical field during spinal surgery .
OBJECTIVE	To determine the effect of milrinone on induced hypotension during spinal surgery in elderly patients .
METHODS	Prospective randomized clinical trial .
METHODS	Forty patients , 60 to 70 years old , ASA I-II , who underwent elective lumbar fusion surgery .
METHODS	Intraoperative hemodynamics , blood loss , hourly urine output , and grade of surgical field .
METHODS	All patients were randomized to group M or N.
METHODS	The study drug was infused after perivertebral muscle retraction until complete interbody fusion .
METHODS	In group M , 50 g/kg/min of milrinone was infused over 10 minutes as a loading dose followed by 0.6 g/kg/min of milrinone as a continuous dose .
METHODS	In group N , an identical volume of normal saline was infused in the same fashion .
METHODS	This study was not funded by commercial or other sponsorship and the authors confirm no conflicts of interest , financial or otherwise .
RESULTS	During infusion of the study drug , the systolic and mean blood pressures were maintained within adequate limits of induced hypotension in group M. Intraoperative blood loss was 445.0226.5 mL in group M and 765.0339.2 mL in group N ( p = .001 ) .
RESULTS	Hourly urine output was 1.40.6 mL in group M and 0.80.2 mL in group N ( p < .001 ) .
RESULTS	The grade of the surgical field was better in group M than in group N ( p = .004 ) .
CONCLUSIONS	We conclude that milrinone is useful for induced hypotension in elderly patients during spinal surgery .

###24616420
OBJECTIVE	The aim of this study was to determine whether providing information about the lifestyle changes required for an individual to lose weight following bariatric surgery would mitigate the negative judgments of that individual .
METHODS	In an experimental design , participants provided their initial impressions of a woman with obesity before learning that she had lost a significant amount of weight through : ( 1 ) diet/exercise , ( 2 ) surgery , or ( 3 ) surgery + diet/exercise .
METHODS	Participants then provided their impressions of the woman after she had lost weight .
RESULTS	For ratings of laziness , competence , and responsibility for weight loss , the individual who lost weight through surgery was rated most negatively , followed by the individual who lost weight through surgery + diet/exercise , with the individual who lost weight through diet/exercise alone rated as least lazy , most competent , and most responsible for her weight loss .
RESULTS	Mediation analyses further showed that group differences in target ratings of laziness/competence were due to perceptions of responsibility for weight loss .
CONCLUSIONS	Providing information about the lifestyle changes required for losing weight following bariatric surgery can somewhat dampen the negative evaluations of surgery patients .
CONCLUSIONS	These findings also highlight the importance of perceived effort in judgments of individuals with obesity .

###25936475
BACKGROUND	We hypothesized that the Laryngoscope with Fiber Optic Reusable Flexible Tip English Macintosh blade ( TMAC ) is beneficial for the intubation of child manikins while performing cardiopulmonary resuscitation ( CPR ) .
BACKGROUND	In the present study , we evaluated the effectiveness of the conventional Macintosh laryngoscope ( MAC ) and TMAC in 3 simulated CPR scenarios .
METHODS	A randomized crossover simulation trial was designed .
METHODS	One hundred seven paramedics intubated the trachea of a PediaSIM CPR training manikin ( FCAE HealthCare , Sarasota , FL ) using the MAC and TMAC in a normal airway scenario ( scenario A ) , normal airway with chest compression scenario ( scenario B ) , and difficult airway with chest compression scenario ( scenario C ) .
METHODS	The participants were directed to make a maximum of 3 attempts in each scenario .
METHODS	The success rate , time required for intubation , Cormack-Lehane grade , dental compression , and the ease of intubation were measured .
RESULTS	The median time of intubation with MAC and TMAC in scenario A was 19.6 ( interquartile range [ IQR ] , 18-23 ) vs 19 ( IQR , 16.2-21 .8 ) ; in scenario B , 29.5 ( IQR , 25-31 ) vs 26 ( IQR , 23.5-29 ) seconds ; and in scenario C , 38 ( IQR , 32.5-45 ) vs 29 ( IQR , 25-31 ) seconds , respectively .
RESULTS	The overall efficacy for each of the scenarios was as follows : in scenario A , it was 100 % vs 100 % ; in scenario B , it was 79.4 % vs 100 % ( P = .007 ) ; and in scenario C , it was 68.2 % vs 90.7 % ( P < .001 ) , respectively .
CONCLUSIONS	The TMAC seems to be a superior intubating device compared with the conventional MAC when used in simulated normal and difficult child airway with chest compression scenarios .
CONCLUSIONS	Future studies should explore the efficacy of TMAC in pediatric clinical emergency settings .

###25419597
OBJECTIVE	The aim of the study was to assess the safety and efficacy of high - and low-dose oral , delayed-release mesalamine in a randomized , double-blind , active control study of children with mild-to-moderately active ulcerative colitis .
METHODS	Patients ages 5 to 17 years , with a Pediatric Ulcerative Colitis Activity Index ( PUCAI ) score of 10 to 55 and a truncated Mayo Score of 1 for both rectal bleeding and stool frequency , were enrolled .
METHODS	They received body weight-dependent doses of oral , delayed-release mesalamine for 6 weeks in a low - ( 27-71 mg g ( -1 ) day ( -1 ) ) or high-dose group ( 53-118 mg g ( -1 ) day ( -1 ) ) .
METHODS	The primary endpoint was treatment success , defined as the proportion of patients who achieved remission ( PUCAI score < 10 ) or partial response ( PUCAI score 10 with a decrease from baseline by 20 points ) .
METHODS	Secondary endpoints included truncated Mayo Score and global assessment of change of disease activity .
RESULTS	The modified intent-to-treat population included 81 of 83 patients enrolled .
RESULTS	Treatment success by PUCAI was achieved by 23 of 41 ( 56 % ) and 22 of 40 ( 55 % ) patients in the mesalamine low - and high-dose groups , respectively ( P = 0.924 ) .
RESULTS	Truncated Mayo Score ( low-dose 30 [ 73 % ] and high-dose 28 [ 70 % ] patients ) and other efficacy results did not differ between the groups .
RESULTS	The type and severity of adverse events were consistent with those reported in previous studies of adults with ulcerative colitis and did not differ between groups .
CONCLUSIONS	Both low - and high-dose oral , delayed-release mesalamine doses were equally effective as short-term treatment of mild-to-moderately active ulcerative colitis in children , without a specific benefit or risk to using either dose .

###24461903
BACKGROUND	The p38 MAPK pathway seems to be involved in pathogenesis of chronic obstructive pulmonary disease ( COPD ) .
BACKGROUND	Losmapimod is a potent and selective inhibitor of p38 MAPK .
BACKGROUND	We assessed the effect of losmapimod on exercise tolerance in patients with COPD .
METHODS	We did this randomised , parallel-group , placebo-controlled trial at 46 secondary care centres in Argentina , Czech Republic , Estonia , Germany , Norway , South Korea , Ukraine , and USA between Nov 4 , 2010 , and Dec 22 , 2011 .
METHODS	We enrolled patients aged 40 years or older with moderate-to-severe COPD ( 6 min walking distance < 350 m ) who were current or previous smokers .
METHODS	Patients were randomly assigned ( 1:1:1:1 ) by a computer generated sequence to one of losmapimod 25 mg , 75 mg , or 15 mg , or placebo , twice daily for 24 weeks .
METHODS	Randomisation was stratified by country and exacerbation history ( block size eight ) .
METHODS	Patients and investigators were masked to treatment assignment .
METHODS	The primary outcome was change in 6 min walking distance between baseline and week 24 , assessed in the intention-to-treat population .
METHODS	This study is registered with ClinicalTrial.gov , number NCT01218126 .
RESULTS	We screened 886 patients , of whom 602 were enrolled and received treatment .
RESULTS	The difference between the placebo group and the losmapimod groups for mean change of 6 min walk distance was not significant : -67 m ( 95 % CI -182 to 49 ) for losmapimod 25 mg , -47 m ( -161 to 68 ) for losmapimod 75 mg , and -34 m ( -151 to 82 ) for losmapimod 15 mg .
RESULTS	The safety profile was much the same in each group , although drug-related adverse events were more common with losmapimod 75 mg ( n = 19 , 13 % ) and losmapimod 15 mg ( n = 20 , 13 % ) than with placebo ( n = 11 , 7 % ) and losmapimod 25 mg ( n = 13 , 9 % ) .
RESULTS	The most common serious adverse events were COPD exacerbation resulting in admission to hospital ( eight patients [ 5 % ] taking placebo , six [ 4 % ] taking losmapimod 25 mg , two [ 1 % ] taking losmapimod 75 mg , and three [ 2 % ] taking losmapimod 15 mg ) and pneumonia ( four [ 3 % ] vs 0 [ 0 % ] vs 1 [ 1 % ] vs 4 [ 3 % ] ) .
CONCLUSIONS	Losmapimod did not cause an improvement in exercise tolerance or lung function , despite being well-tolerated in this COPD population .
BACKGROUND	GlaxoSmithKline .

###25781440
OBJECTIVE	Despite antirestenotic efficacy of coronary drug-eluting stents ( DES ) compared with bare metal stents ( BMS ) , the relative risk of stent thrombosis and adverse cardiovascular events is unclear .
OBJECTIVE	Although dual antiplatelet therapy ( DAPT ) beyond 1 year provides ischemic event protection after DES , ischemic event risk is perceived to be less after BMS , and the appropriate duration of DAPT after BMS is unknown .
OBJECTIVE	To compare ( 1 ) rates of stent thrombosis and major adverse cardiac and cerebrovascular events ( MACCE ; composite of death , myocardial infarction , or stroke ) after 30 vs 12 months of thienopyridine in patients treated with BMS taking aspirin and ( 2 ) treatment duration effect within the combined cohorts of randomized patients treated with DES or BMS as prespecified secondary analyses .
METHODS	International , multicenter , randomized , double-blinded , placebo-controlled trial comparing extended ( 30-months ) thienopyridine vs placebo in patients taking aspirin who completed 12 months of DAPT without bleeding or ischemic events after receiving stents .
METHODS	The study was initiated in August 2009 with the last follow-up visit in May 2014 .
METHODS	Continued thienopyridine or placebo at months 12 through 30 after stent placement , in 11,648 randomized patients treated with aspirin , of whom 1687 received BMS and 9961 DES .
METHODS	Stent thrombosis , MACCE , and moderate or severe bleeding .
RESULTS	Among 1687 patients treated with BMS who were randomized to continued thienopyridine vs placebo , rates of stent thrombosis were 0.5 % vs 1.11 % ( n = 4 vs 9 ; hazard ratio [ HR ] , 0.49 ; 95 % CI , 0.15-1 .64 ; P = .24 ) , rates of MACCE were 4.04 % vs 4.69 % ( n = 33 vs 38 ; HR , 0.92 ; 95 % CI , 0.57-1 .47 ; P = .72 ) , and rates of moderate/severe bleeding were 2.03 % vs 0.90 % ( n = 16 vs 7 ; P = .07 ) , respectively .
RESULTS	Among all 11,648 randomized patients ( both BMS and DES ) , stent thrombosis rates were 0.41 % vs 1.32 % ( n = 23 vs 74 ; HR , 0.31 ; 95 % CI , 0.19-0 .50 ; P < .001 ) , rates of MACCE were 4.29 % vs 5.74 % ( n = 244 vs 323 ; HR , 0.73 ; 95 % CI , 0.62-0 .87 ; P < .001 ) , and rates of moderate/severe bleeding were 2.45 % vs 1.47 % ( n = 135 vs 80 ; P < .001 ) .
CONCLUSIONS	Among patients undergoing coronary stent placement with BMS and who tolerated 12 months of thienopyridine , continuing thienopyridine for an additional 18 months compared with placebo did not result in statistically significant differences in rates of stent thrombosis , MACCE , or moderate or severe bleeding .
CONCLUSIONS	However , the BMS subset may have been underpowered to identify such differences , and further trials are suggested .
BACKGROUND	clinicaltrials.gov Identifier : NCT00977938 .

###24667169
OBJECTIVE	To evaluate the effectiveness of low-intensity pulsed ultrasound ( LIPUS ) for the improvement of lower limb bone stress injuries in a civilian population .
METHODS	A prospective , randomized , double-blinded , placebo-controlled trial to compare LIPUS with placebo .
METHODS	Civilian private practice population in Sydney , Australia .
METHODS	Subjects were recruited if a grade II-IV bone stress injury was diagnosed on magnetic resonance imaging ( MRI ) of either the postero-medial tibia , fibula or second , third , or fourth metatarsal .
METHODS	Subjects of all levels of sporting activity were included .
METHODS	Thirty subjects were initially recruited , and 23 subjects were included in the final analysis .
METHODS	Subjects were randomized into either the treatment or placebo arm and matched to the site of injury ( tibia , fibula , or metatarsal ) .
METHODS	Subjects in both arms used either treatment or placebo devices for 20 minutes daily for 4 weeks .
METHODS	Six clinical parameters ( night pain , pain at rest , pain on walking , pain with running , tenderness , and pain with single leg hop ) were compared before and after intervention .
METHODS	The changes in MRI grade and bone marrow edema size were also compared .
RESULTS	There were no significant differences between the treatment and placebo conditions for changes in MRI grading ( 2.2 vs 2.4 , P = 0.776 ) or bone marrow edema size ( 3 vs 4.1 , P = 0.271 ) .
RESULTS	There were no significant differences between the treatment and placebo conditions for the 6 clinical parameters .
CONCLUSIONS	Low-intensity pulsed ultrasound was found not to be an effective treatment for the healing of lower limb bone stress injuries in this study .
CONCLUSIONS	However , this was measured over a relatively short duration of 4 weeks in a small , mostly female population .
CONCLUSIONS	This double-blinded , randomized , placebo-controlled trial has shown that LIPUS is not an effective treatment for lower limb bone stress injuries .

###24709487
BACKGROUND	Vandetanib is an oral tyrosine kinase inhibitor of VEGFR-2 / 3 , EGFR and RET , which has demonstrated clinical activity as a single agent and in combination with taxanes .
BACKGROUND	We explored the efficacy , safety and toxicity of docetaxel and vandetanib in women with recurrent ovarian cancer ( OC ) .
METHODS	Women with refractory or progressive OC were randomised 1:1 to docetaxel ( 75 mg/m ( 2 ) , IV ) + vandetanib ( 100mg daily , PO , D+V ) or docetaxel ( 75 mg/m ( 2 ) , D ) .
METHODS	Up to three additional cytotoxic regimens for recurrence and prior anti-angiogenic agents ( as primary therapy ) were allowed .
METHODS	The primary end-point was progression free survival ( PFS ) .
METHODS	The study had 84 % power to detect a PFS hazard ratio of 0.65 , using a one-sided P of 0.1 .
METHODS	This corresponds to an increase in median PFS from 3.6 months to 5.6 months .
METHODS	Patients progressing on D were allowed to receive single agent vandetanib ( D V ) .
RESULTS	131 Patients were enrolled ; two were excluded .
RESULTS	16 % had received prior anti-angiogenic therapy .
RESULTS	The median PFS estimates were 3.0 mos ( D+V ) versus 3.5 ( D ) ; HR : 0.99 ( 80 % CI : 0.79-1 .26 ) .
RESULTS	61 Patients on D+V were assessable for toxicity ; 20 ( 33 % ) had treatment-related Grade ( G ) 4 events , primarily haematologic .
RESULTS	Similarly , 17 ( 27 % ) of 64 patients receiving D had G4 events , primarily haematologic .
RESULTS	27 Evaluable patients crossed-over to V. 1/27 ( 4 % ) experienced a G4 event .
RESULTS	G3 diarrhoea was observed in 4 % D V patients .
RESULTS	Median OS was 14 mos ( D+V ) versus 18 mos ( D V ) ; HR ( OS ) : 1.25 ( 80 % CI : 0.93-1 .68 ) .
RESULTS	Crossover vandetanib response was 4 % ( 1/27 evaluable patients ) .
RESULTS	High plasma IL-8 levels were associated with response to D+V .
CONCLUSIONS	Combination docetaxel + vandetanib did not prolong PFS relative to docetaxel alone in OC patients .
CONCLUSIONS	No unexpected safety issues were identified .

###24249843
OBJECTIVE	To identify the effect of a novel augmented core stabilization exercise technique on physical function , pain and core stability in patients with chronic low back pain .
METHODS	A block randomized controlled trial with two groups .
METHODS	A sports rehabilitation clinic .
METHODS	Forty patients with low back pain ( 20 experimental , mean ( SD ) age 50.35 ( 9.26 ) years and 20 control , 51.30 ( 7.01 ) ) , 19 men and 21 women .
METHODS	In the experimental group ankle dorsiflexion was used in addition to drawing in the abdominal wall ; the control group involved drawing in the abdominal wall alone .
METHODS	Both groups received the same conventional physical therapy training three days a week for eight weeks .
METHODS	Physical disability instruments ; Oswestry Disability Index and Roland Morris Disability Questionnaire ; pain intensity assessments ; visual analogue scale , Pain Disability Index , and a pain rating scale ; and core stability measures , such as the active straight leg raise , were determined at pretest , posttest and two-month follow-up .
RESULTS	After the intervention , the experimental group showed significant greater improvement at two months compared with the control group .
RESULTS	Physical disability results included Oswestry Disability Index ( P = 0.001 , from 24.25 ( 7.08 ) to 13.35 ( 4.17 ) ) and Roland Morris Disability Questionnaire ( P = 0.001 , from 15.55 ( 1.99 ) to 8.15 ( 1.69 ) ) , pain intensity including visual analogue scale ( P = 0.001 , from 6.30 ( 1.03 ) to 3.35 ( 0.59 ) ) , Pain Disability Index ( P = 0.001 , 31.25 ( 5.44 ) to 19.00 ( 3.58 ) ) and pain rating scale ( P = 0.001 , from 72.25 ( 18.73 ) to 50.10 ( 15.47 ) ) , and the core stability test such as active straight leg raise ( P = 0.001 , from 7.40 ( 0.75 ) to 2.15 ( 0.49 ) ) .
CONCLUSIONS	This study provides the clinical evidence that adding ankle dorsiflexion to drawing in the abdominal wall gave increased benefit in terms of physical disability , pain and core stability in patients with chronic low back pain .

###24508795
OBJECTIVE	To explore the biomechanical changes induced by repeated cross-linking using scanning acoustic microscopy ( SAM ) .
METHODS	Thirty human corneas were divided into three groups .
METHODS	In group A , five corneas were cross-linked once .
METHODS	In group B , five corneas were cross-linked twice , 24 hours apart .
METHODS	In group C , five corneas were cross-linked three times , 24 hours apart .
METHODS	The contralateral controls in all groups had similar treatment but without UV-A .
METHODS	The speed of sound , which is directly proportional to the square root of the tissue 's elastic modulus , was assessed using SAM .
RESULTS	In group A , the speed of sound of the treated corneas was 1677.38 10.70 ms ( -1 ) anteriorly and 1603.90 9.82 ms ( -1 ) posteriorly , while it was 1595.23 9.66 ms ( -1 ) anteriorly and 1577.13 8.16 ms ( -1 ) posteriorly in the controls .
RESULTS	In group B , the speed of sound of the treated corneas was 1746.33 23.37 ms ( -1 ) anteriorly and 1631.60 18.92 ms ( -1 ) posteriorly , while it was 1637.57 22.15 ms ( -1 ) anteriorly and 1612.30 22.23 ms ( -1 ) posteriorly in the controls .
RESULTS	In group C , the speed of sound of the treated corneas was 1717.97 18.92 ms ( -1 ) anteriorly and 1616.62 17.58 ms ( -1 ) posteriorly , while it was 1628.69 9.37 ms ( -1 ) anteriorly and 1597.68 11.97 ms ( -1 ) posteriorly in the controls .
RESULTS	The speed of sound in the anterior ( 200 200 m ) region between the cross-linked and control corneas in groups A , B , and C was increased by a factor of 1.051 ( P = 0.005 ) , 1.066 ( P = 0.010 ) , and 1.055 ( P = 0.005 ) respectively .
RESULTS	However , there was no significant difference among the cross-linked corneas in all groups ( P = 0.067 ) .
CONCLUSIONS	A significant increase in speed of sound was found in all treated groups compared with the control group ; however , the difference among the treated groups is not significant , suggesting no further cross-links are induced when collagen cross-linking treatment is repeated .

###24284444
BACKGROUND	Although consuming dietary protein above current recommendations during energy deficit ( ED ) preserves lean body mass , concerns have been raised regarding the effects of high-protein diets on bone health .
OBJECTIVE	The objective was to determine whether calcium homeostasis and bone turnover are affected by high-protein diets during weight maintenance ( WM ) and ED .
METHODS	In a randomized , parallel-design , controlled trial of 32 men and 7 women , volunteers were assigned diets providing protein at 0.8 [ Recommended Dietary Allowance ( RDA ) ] , 1.6 ( 2 RDA ) , or 2.4 ( 3 RDA ) g kg ( -1 ) d ( -1 ) for 31 d. Ten days of WM preceded 21 d of ED , during which total daily ED was 40 % , achieved by reduced dietary energy intake ( 30 % ) and increased physical activity ( 10 % ) .
METHODS	The macronutrient composition ( protein g kg ( -1 ) d ( -1 ) and % fat ) was held constant from WM to ED .
METHODS	Calcium absorption ( ratio of ( 44 ) Ca to ( 42 ) Ca ) and circulating indexes of bone turnover were determined at day 8 ( WM ) and day 29 ( ED ) .
RESULTS	Regardless of energy state , mean ( SEM ) urinary pH was lower ( P < 0.05 ) at 2 RDA ( 6.28 0.05 ) and 3 RDA ( 6.23 0.06 ) than at the RDA ( 6.54 0.06 ) .
RESULTS	However , protein had no effect on either urinary calcium excretion ( P > 0.05 ) or the amount of calcium retained ( P > 0.05 ) .
RESULTS	ED decreased serum insulin-like growth factor I concentrations and increased serum tartrate-resistant acid phosphatase and 25-hydroxyvitamin D concentrations ( P < 0.01 ) .
RESULTS	Remaining markers of bone turnover and whole-body bone mineral density and content were not affected by either the protein level or ED ( P > 0.05 ) .
CONCLUSIONS	These data demonstrate that short-term consumption of high-protein diets does not disrupt calcium homeostasis and is not detrimental to skeletal integrity .
CONCLUSIONS	This trial was registered at www.clinicaltrials.gov as NCT01292395 .

###25523036
BACKGROUND	Malnutrition is an independent risk factor of postoperative morbidity and mortality and it 's observed in 20 to 50 % of surgical patients .
BACKGROUND	Preoperative interventions to optimize the nutritional status , reduce postoperative complications and enteral nutrition has proven to be superior to the parenteral one .
BACKGROUND	Moreover , regardless of the nutritional status of the patient , surgery impairs the immunological response , thus increasing the risk of postoperative sepsis .
BACKGROUND	Immunonutrition has been developed to improve the immunometabolic host response in perioperative period and it has been proven to reduce significantly postoperative infectious complications and length of hospital stay in patients undergoing elective gastrointestinal surgery for tumors .
BACKGROUND	We hypothesize that a preoperative oral immunonutrition ( ORAL IMPACT ) can reduce postoperative morbidity in liver resection for cancer .
METHODS	Prospective multicenter randomized placebo-controlled double-blind phase IV trial with two parallel treatment groups receiving either study product ( ORAL IMPACT ) or control supplement ( isocaloric isonitrogenous supplement -- IMPACT CONTROL ) for 7 days before liver resection for cancer .
METHODS	A total of 400 patients will be enrolled .
METHODS	Patients will be stratified according to the type of hepatectomy , the presence of chronic liver disease and the investigator center .
METHODS	The main end-point is to evaluate in intention-to-treat analysis the overall 30-day morbidity .
METHODS	Secondary end-points are to assess the 30-day infectious and non-infectious morbidity , length of antibiotic treatment and hospital stay , modifications on total food intake , compliance to treatment , side-effects of immunonutrition , impact on liver regeneration and sarcopenia , and to perform a medico-economic analysis .
CONCLUSIONS	The overall morbidity rate after liver resection is 22 % to 42 % .
CONCLUSIONS	Infectious post-operative complications ( 12 % to 23 % ) increase the length of hospital stay and costs and are responsible for a quarter of 30-day mortality .
CONCLUSIONS	Various methods have been advocated to decrease the rate of postoperative complications but there is no evidence to support or refute the use of any treatment and further trials are required .
CONCLUSIONS	The effects of preoperative oral immunonutrition in non-cirrhotic patients undergoing liver resection for cancer are unknown .
CONCLUSIONS	The present trial is designed to evaluate whether the administration of a short-term preoperative oral immunonutrition can reduce postoperative morbidity in non-cirrhotic patients undergoing liver resection for cancer .
BACKGROUND	Clinicaltrial.gov : NCT02041871 .

###25569817
OBJECTIVE	Removal of the ovaries is common during surgery for endometrial cancer .
OBJECTIVE	However , because loss of the ovaries can cause several health problems in patients , strategies for the prevention of such problems need to be established .
OBJECTIVE	Hence , we decided to conduct a multicenter randomized clinical trial to assess the effect of raloxifene on bone mineral density ( BMD ) , bone metabolism , and the lipid profile of patients who had undergone surgery for patients with endometrial cancer .
METHODS	Patients with endometrial cancer were enrolled after treatment .
METHODS	The participants were randomized into 2 groups : group 1 included 39 women who received alfacalcidol ( 1 g/d ) alone and group 2 included 37 women who received alfacalcidol and the test drug , raloxifene hydrochloride , at a dose of 60 mg/d .
METHODS	The BMD of lumbar spine and femoral neck , serum bone markers , as well as lipid profile parameters were evaluated at enrollment as well as 6 , 12 , and 24 months after the enrollment .
METHODS	The primary efficacy end point was the percentage change from baseline to 24 months in lumbar spine ( L2-L4 ) and femoral neck BMD .
RESULTS	Sixty-four women completed the 24-month study .
RESULTS	At 24 months , the lumbar and femoral neck BMDs were significantly increased in group 2 compared with group 1 ( 3.5 % vs -0.8 % and 2.3 % vs -2.8 % , respectively ) .
RESULTS	In group 2 , low-density lipoprotein-cholesterol levels were significantly reduced by 13.6 % and serum N-terminal telopeptide of type I collagen as well as bone-specific alkaline phosphatase values were significantly reduced by 16.7 % and 25.7 % , respectively .
RESULTS	The patients who received adjuvant therapy for endometrial cancer showed a significantly higher response to raloxifene ( 5.8 % vs 1.9 % ) .
RESULTS	Recurrence was detected in 2 ( 2.6 % ) patients in group 1 .
RESULTS	No severe adverse events were noted in any patient during the study period .
CONCLUSIONS	Raloxifene exerts positive effects on BMD , bone metabolism , and lipid profile parameters and could provide an improved therapeutic option for patients with endometrial cancer .

###25558975
BACKGROUND	There is a consensus that exercise therapy should be used as a therapeutic approach in chronic low back pain ( CLBP ) but little consensus has been reached about the preferential type of therapy .
BACKGROUND	Due to the heterogeneity of the population no clear effect of specific therapy interventions are found .
BACKGROUND	Probably a specific subgroup of the investigated population will benefit from the intervention and another subgroup will not benefit , looking at the total investigated population no significant effects can be found .
BACKGROUND	Therefore there is a need for the development of clinical prediction rules ( CPRs ) .
BACKGROUND	Objectives for this trial are first , the derivation of CPRs to predict treatment response to three forms of exercise therapy for patients with nonspecific CLBP .
BACKGROUND	Secondly , we aim to validate a CPR for the three forms of exercise therapy for patients with nonspecific CLBP .
METHODS	The study design is a randomized controlled trial .
METHODS	Patients with nonspecific CLBP of more than three months duration are recruited at the Antwerp University Hospital ( Belgium ) and Apra Rehabilitation Hospital .
METHODS	After examination , patients are randomly assigned to one of three intervention groups : motor control therapy , general active exercise therapy and isometric training therapy .
METHODS	All patients will undergo 18 treatment sessions during nine weeks .
METHODS	Measurements will be taken at baseline , nine weeks , six months and at one year .
METHODS	The primary outcome used is the Modified Oswestry Disability Questionnaire score .
METHODS	For each type of exercise therapy a CPR will be derived and validated .
METHODS	For validation , the CPR will be applied to divide each treatment group into two subgroups ( matched and unmatched therapy ) using the baseline measurements .
METHODS	We predict a better therapeutic effect for matched therapy .
CONCLUSIONS	A randomized controlled trial has not previously been performed for the development of a CPR for exercise therapy in CLBP patients .
CONCLUSIONS	Only one CPR was described in a single-arm design for motor control therapy in sub-acute non-radicular LBP patients .
CONCLUSIONS	In this study , a sufficiently large sample will be included in both the derivation and validation phase .
BACKGROUND	This trial was registered with Clinicaltrials.gov on 10 February 2014 , registration number : NCT02063503 .

###24708643
BACKGROUND	In a large randomised trial in patients with seasonal allergic rhinitis ( SAR ) , acupuncture was superior compared to sham acupuncture and rescue medication .
BACKGROUND	The aim of this paper is to describe the characteristics of the trial 's participating physicians and to describe the trial intervention in accordance with the STRICTA ( Standards for Reporting Interventions in Controlled Trials of Acupuncture ) guidelines , to make details of the trial intervention more transparent to researchers and physicians .
METHODS	ACUSAR ( ACUpuncture in Seasonal Allergic Rhinitis ) was a three-armed , randomised , controlled multicentre trial .
METHODS	422 SAR patients were randomised to semi-standardised acupuncture plus rescue medication ( RM , cetirizine ) , sham acupuncture plus RM or RM alone .
METHODS	We sent a questionnaire to trial physicians in order to evaluate their characteristics regarding their education about and experience in providing acupuncture .
METHODS	During the trial , acupuncturists were asked to diagnose all of their patients according to Chinese Medicine ( CM ) as a basis for the semi-standardised , individualized intervention in the acupuncture group .
METHODS	Every acupuncture point used in this trial had to be documented after each session
RESULTS	Acupuncture was administered in outpatient clinics by 46 ( mean age 4710years ; 24 female / 22 male ) conventionally-trained medical doctors ( 67 % with postgraduate specialization such as internal or family medicine ) with additional extensive acupuncture training ( median 500hours ( 1st quartile 350 , 3rd quartile 1000hours with 73 % presenting a B-diploma in acupuncture training ( 350hours ) ) and experience ( mean 14years in practice ) .
RESULTS	The most reported traditional CM diagnosis was ` wind-cold invading the lung ' ( 37 % ) and ` wind-heat invading the lung ' ( 37 % ) , followed by ` lung and spleen qi deficiency ' ( 9 % ) .
RESULTS	The total number of needles used was higher in the acupuncture group compared to the sham acupuncture group ( 15.7 2.5 vs. 10.0 1.6 ) .
CONCLUSIONS	The trial interventions were provided by well educated and experienced acupuncturists .
CONCLUSIONS	The different number of needles in both intervention groups could be possibly a reason for the better clinical effect in SAR patients .
CONCLUSIONS	For future trials it might be more appropriate to ensure that acupuncture and sham acupuncture groups should each be treated by a similar number of needles .
BACKGROUND	ClinicalTrials.gov : NCT00610584 .

###24827034
BACKGROUND	Current therapeutic options for Chagas ' disease are limited to benznidazole and nifurtimox , which have been associated with low cure rates in the chronic stage of the disease and which have considerable toxicity .
BACKGROUND	Posaconazole has shown trypanocidal activity in murine models .
METHODS	We performed a prospective , randomized clinical trial to assess the efficacy and safety of posaconazole as compared with the efficacy and safety of benznidazole in adults with chronic Trypanosoma cruzi infection .
METHODS	We randomly assigned patients to receive posaconazole at a dose of 400 mg twice daily ( high-dose posaconazole ) , posaconazole at a dose of 100 mg twice daily ( low-dose posaconazole ) , or benznidazole at a dose of 150 mg twice daily ; all the study drugs were administered for 60 days .
METHODS	We assessed antiparasitic activity by testing for the presence of T. cruzi DNA , using real-time polymerase-chain-reaction ( rt-PCR ) assays , during the treatment period and 10 months after the end of treatment .
METHODS	Posaconazole absorption was assessed on day 14 .
RESULTS	The intention-to-treat population included 78 patients .
RESULTS	During the treatment period , all the patients tested negative for T. cruzi DNA on rt-PCR assay beyond day 14 , except for 2 patients in the low-dose posaconazole group who tested positive on day 60 .
RESULTS	During the follow-up period , in the intention-to-treat analysis , 92 % of the patients receiving low-dose posaconazole and 81 % receiving high-dose posaconazole , as compared with 38 % receiving benznidazole , tested positive for T. cruzi DNA on rt-PCR assay ( P < 0.01 for the comparison of the benznidazole group with either posaconazole group ) ; in the per-protocol analysis , 90 % of the patients receiving low-dose posaconazole and 80 % of those receiving high-dose posaconazole , as compared with 6 % receiving benznidazole , tested positive on rt-PCR assay ( P < 0.001 for the comparison of the benznidazole group with either posaconazole group ) .
RESULTS	In the benznidazole group , treatment was discontinued in 5 patients because of severe cutaneous reactions ; in the posaconazole groups , 4 patients had aminotransferase levels that were more than 3 times the upper limit of the normal range , but there were no discontinuations of treatment .
CONCLUSIONS	Posaconazole showed antitrypanosomal activity in patients with chronic Chagas ' disease .
CONCLUSIONS	However , significantly more patients in the posaconazole groups than in the benznidazole group had treatment failure during follow-up .
CONCLUSIONS	( Funded by the Ministry of Health , Spain ; CHAGASAZOL ClinicalTrials.gov number , NCT01162967 . )

###25616927
OBJECTIVE	This study sought to determine clinical , procedural , and treatment factors associated with acute stent thrombosis ( AST ) in the EUROMAX ( European Ambulance Acute Coronary Syndrome Angiography ) trial .
BACKGROUND	Bivalirudin started during transport for primary percutaneous coronary intervention ( PCI ) for ST-segment elevation myocardial infarction significantly reduced major bleeding compared with heparin with or without glycoprotein IIb/IIIa inhibitors ( GPI ) , but it was associated with an increase in AST .
METHODS	We compared patients with ( n = 12 ) or without AST ( n = 2,184 ) regarding baseline , clinical , and procedural characteristics and antithrombotic treatment strategies ( choice of P2Y12 inhibitor , post-primary PCI bivalirudin infusion dose [ 0.25 mg/kg/h , or BIV-LOW ] vs. [ 1.75 mg/kg/h , or BIV-PCI ] vs. heparin GPI ) .
METHODS	Logistic regression was performed to identify independent correlates of AST .
RESULTS	The overall AST rate was 0.6 % and was higher with bivalirudin than with heparin GPI ( 1.1 % vs. 0.2 % ; p = 0.007 ) .
RESULTS	Median time to AST was 2.3 h ( interquartile range : 1.9 to 2.8 h ) .
RESULTS	Patients with AST had less hypertension ( 2 of 14 [ 14.0 % ] vs. 961 of 2,182 [ 44.0 % ] ; p = 0.03 ) , and more frequently received GPI ( 11 of 14 [ 78.6 % ] vs. 880 of 2,183 [ 40.3 % ] ; p = 0.004 ) .
RESULTS	Multivariate analysis using Firth penalized maximum likelihood estimation found hypertension ( odds ratio [ OR ] : 0.24 , 95 % confidence interval [ CI ] : 0.07 to 0.92 ; p = 0.037 ) and BIV-LOW ( OR : 5.8 , 95 % CI : 1.5 to 22.2 ; p = 0.010 ) predictive of AST .
RESULTS	Choice of P2Y12 inhibitor had no impact on AST .
RESULTS	Compared with heparin GPI , AST rates were higher for BIV-LOW ( 11 of 670 [ 1.6 % ] vs. 2 of 947 [ 0.2 % ] ; p = 0.008 ) , but not different for BIV-PCI ( 1 of 244 [ 0.4 % ] ; p = 0.588 ) .
CONCLUSIONS	In this post-hoc analysis from EUROMAX , AST occurred very early and was not mitigated by the novel P2Y12 inhibitors .
CONCLUSIONS	Prolonging the bivalirudin infusion at the PCI dose ( but not at a lower dose ) appeared to mitigate the risk of AST .

###26322666
BACKGROUND	The PENPACT-1 trial compared virologic thresholds to determine when to switch to second-line antiretroviral therapy ( ART ) .
BACKGROUND	Using PENPACT-1 data , we aimed to describe HIV-1 drug resistance accumulation on first-line ART by virologic threshold .
METHODS	PENPACT-1 had a 2 2 factorial design , randomizing HIV-infected children to start protease inhibitor ( PI ) versus nonnucleoside reverse transcriptase inhibitor ( NNRTI ) - based ART , and switch at a 1000 copies/mL versus 30,000 copies/mL threshold .
METHODS	Switch criteria were not achieving the threshold by week 24 , confirmed rebound above the threshold thereafter , or Center for Disease Control and Prevention stage C event .
METHODS	Resistance tests were performed on samples 1000 copies/mL before switch , resuppression , and at 4-years/trial end .
RESULTS	Sixty-seven children started PI-based ART and were randomized to switch at 1000 copies/mL ( PI-1000 ) , 64 PIs and 30,000 copies/mL ( PI-30 ,000 ) , 67 NNRTIs and 1000 copies/mL ( NNRTI-1000 ) , and 65 NNRTI and 30,000 copies/mL ( NNRTI-30 ,000 ) .
RESULTS	Ninety-four ( 36 % ) children reached the 1000 copies/mL switch criteria during 5-year follow-up .
RESULTS	In 30,000 copies/mL threshold arms , median time from 1000 to 30,000 copies/mL switch criteria was 58 ( PI ) versus 80 ( NNRTI ) weeks ( P = 0.81 ) .
RESULTS	In NNRTI-30 ,000 , more nucleoside reverse transcriptase inhibitor ( NRTI ) resistance mutations accumulated than other groups .
RESULTS	NNRTI mutations were selected before switching at 1000 copies/mL ( 23 % NNRTI-1000 , 27 % NNRTI-30 ,000 ) .
RESULTS	Sixty-two children started abacavir + lamivudine , 166 lamivudine + zidovudine or stavudine , and 35 other NRTIs .
RESULTS	The abacavir + lamivudine group acquired fewest NRTI mutations .
RESULTS	Of 60 switched to second-line , 79 % PI-1000 , 63 % PI-30 ,000 , 64 % NNRTI-1000 , and 100 % NNRTI-30 ,000 were < 400 copies/mL 24 weeks later .
CONCLUSIONS	Children on first-line NNRTI-based ART who were randomized to switch at a higher virologic threshold developed the most resistance , yet resuppressed on second-line .
CONCLUSIONS	An abacavir + lamivudine NRTI combination seemed protective against development of NRTI resistance .

###24738713
BACKGROUND	Morbidly obese patients are more prone to desaturation of arterial blood during apnea with induction of anesthesia than are non-obese .
BACKGROUND	This study aimed to assess the effect of low-pressure continuous positive airway pressure ( CPAP ) with pressure support ventilation ( PSV ) during pre-oxygenation on partial oxygen pressure in arterial blood ( PaO2 ) immediately after tracheal intubation ( post-intubation PaO2 ) .
METHODS	Forty-four adult patients scheduled for laparoscopic gastric bypass surgery were pre-oxygenated with 80 % O2 for 2 min , randomized either to CPAP 5 cm H2O + PSV 5 cm H2O ( CPAP/PSV , n = 22 ) or neutral-pressure breathing without CPAP/PSV ( control , n = 22 ) .
METHODS	Anesthesia was induced in a rapid-sequence protocol and the trachea was intubated without prior mask ventilation .
METHODS	Arterial blood gases were measured before pre-oxygenation , before induction of anesthesia , and immediately following intubation , before the first positive pressure breath .
RESULTS	After pre-oxygenation , partial carbondioxide pressure was significantly lower in the CPAP/PSV group ( 4.9 0.5 kPa ) , ( mean standard deviation ) than in the control group ( 5.2 0.7 kPa ) ( P = 0.025 ) .
RESULTS	Post-preoxygenation PaO2 did not differ between the groups , but post-intubation PaO2 was significantly higher in the CPAP/PSV group ( 32.2 4.1 kPa ) than in the control group ( 23.8 8.8 kPa ) ( P < 0.001 ) .
RESULTS	In the control group , nadir oxygen saturation was lower ( median 98 % , range 83-99 % ) than in the CPAP/PSV group ( median 99 % , range 97-99 % , P = 0.011 ) .
CONCLUSIONS	In morbidly obese patients , low-pressure CPAP combined with low-pressure PSV during pre-oxygenation resulted in better oxygenation , compared with neutral-pressure breathing , and prevented desaturation episodes .

###24257459
BACKGROUND	The internal thoracic artery ( ITA ) has been accepted worldwide as a first choice conduit for myocardial revascularisation .
BACKGROUND	It still remains questionable what is the best method for ITA harvesting in a skeletonized fashion according to structural integrity of artery , as a risk factor of early and late graft failure .
BACKGROUND	The purpose of this study was to determine the impact of the ultra-high radiofrequency energy used for ITA harvesting on arterial structural integrity , in particular on the endothelial layer .
METHODS	Seventy-four ITA specimens were divided into two groups depending on device used for harvesting ( radiofrequency-knife ( RF ) or electrocauter ( EC ) ) .
METHODS	Thermal damage on arterial structural integrity was measured using light microscope , morphometric imaging analysis and immunohistochemical methods .
RESULTS	Thermal damage of endothelium was 2.8 times higher in EC than in RF group ( p = 0.041 ) and 5 times higher in patients older than 66 years of age ( p = 0.002 ) .
RESULTS	Extent of endothelial damage ( graded from 0 to 3 ) was significantly higher in EC group ( p = 0.03 ) .
RESULTS	Also , in EC group , in patients older than 66 years of age higher proportion of extent of endothelial damage was found ( p = 0.027 ) .
CONCLUSIONS	The endothelial damage was more often in EC than in RF group as in the patients older than 66 years of age .
CONCLUSIONS	Demonstrated results suggest that the radiosurgery in comparison to conventional electrocautery is safe and effective method , and significantly reduces thermal damage to endothelial layer of artery .

###24373019
OBJECTIVE	To assess the efficacy and safety of imidafenacin compared with propiverine for treatment of overactive bladder ( OAB ) in Korean patients .
METHODS	Patients with OAB symptoms were randomised to double-blind treatment with 0.1 mg of imidafenacin twice daily ( group A ) or propiverine 20 mg once daily ( group B ) for 12-week regimen , and assessed for efficacy and safety .
METHODS	The primary efficacy outcome was per cent change of weekly urgency urinary incontinence ( UUI ) episodes at week 12 .
METHODS	The secondary efficacy outcomes were changes in the micturitions per day , urine volume voided per micturition , urgency episodes per day , complete disappearance of incontinence episodes and severity of urgency from baseline to week 12 .
METHODS	Quality of life and safety profiles were also compared .
RESULTS	Of 162 patients randomised , 140 completed the study protocol .
RESULTS	The per cent change of weekly UUI episodes at week 12 was -69.1 % in group A and -70.4 % in group B ( both p < 0.0001 ) .
RESULTS	The lower limit of 95 % one-sided confidence interval of the difference between the groups was above the non-inferiority margin ( -19.42 % ) .
RESULTS	Other voiding parameters and quality of life significantly improved at week 12 in both the groups .
RESULTS	The discontinuation rates caused by adverse events were low in both the groups .
RESULTS	While dry mouth was the most common adverse event ( group A : 28.4 % vs. B : 30.4 % , p = 0.783 ) , the severity of dry mouth was significantly less in the group A than B ( p = 0.042 ) There were no significant differences in other safety profiles .
CONCLUSIONS	After the 12-week treatment of imidafenacin 0.1 mg twice daily , all OAB symptoms and quality of life improved .
CONCLUSIONS	Imidafenacin was not inferior to propiverine for the reduction of UUI episodes , and was better tolerated than propiverine in the safety profile .
CONCLUSIONS	Our results indicate that imidafenacin is a safe and effective drug in Korean patients with OAB .

###24903062
BACKGROUND	Infants with unilateral brain lesions are at high risk of developing unilateral cerebral palsy ( CP ) .
BACKGROUND	Given the great plasticity of the young brain , possible interventions for infants at risk of unilateral CP deserve exploration .
BACKGROUND	Constraint-induced movement therapy ( CIMT ) is known to be effective for older children with unilateral CP but is not systematically used for infants .
BACKGROUND	The development of CIMT for infants ( baby-CIMT ) is described here , as is the methodology of an RCT comparing the effects on manual ability development of baby-CIMT versus baby-massage .
BACKGROUND	The main hypothesis is that infants receiving baby-CIMT will develop manual ability in the involved hand faster than will infants receiving baby-massage in the first year of life .
METHODS	The study will be a randomised , controlled , prospective parallel-group trial .
METHODS	Invited infants will be to be randomised to either the baby-CIMT or the baby-massage group if they : 1 ) are at risk of developing unilateral CP due to a known neonatal event affecting the brain or 2 ) have been referred to Astrid Lindgren Children 's Hospital due to asymmetric hand function .
METHODS	The inclusion criteria are age 3-8 months and established asymmetric hand use .
METHODS	Infants in both groups will receive two 6-weeks training periods separated by a 6-week pause , for 12 weeks in total of treatment .
METHODS	The primary outcome measure will be the new Hand Assessment for Infants ( HAI ) for evaluating manual ability .
METHODS	In addition , the Parenting Sense of Competence scale and Alberta Infant Motor Scale will be used .
METHODS	Clinical neuroimaging will be utilized to characterise the brain lesion type .
METHODS	To compare outcomes between treatment groups generalised linear models will be used .
CONCLUSIONS	The model of early intensive intervention for hand function , baby-CIMT evaluated by the Hand Assessment for Infants ( HAI ) will have the potential to significantly increase our understanding of how early intervention of upper limb function in infants at risk of developing unilateral CP can be performed and measured .
BACKGROUND	SFO-V4072 / 2012 , 05/22/2013 .

###24964348
BACKGROUND	CRTH2 is a G-protein-coupled receptor on T helper2 cells that mediates pro-inflammatory effects of prostaglandin D2 in allergic responses .
OBJECTIVE	To investigate the tolerability and pharmacokinetics of setipiprant ( ACT-129968 ) , a selective orally active CRTH2 antagonist , in allergic asthmatics and to assess the protective effects of multiple doses of this drug against allergen-induced airway responses .
METHODS	In this 3-centre , double-blinded , placebo-controlled , cross-over study , 18 allergic asthmatic males were randomized to setipiprant 1000 mg or matching placebo b.i.d. for 5 consecutive days .
METHODS	Study periods were separated by a washout of 3 weeks .
METHODS	On study day 4 , subjects underwent a standardized allergen challenge and airway response was recorded by FEV1 until 10 h post-allergen .
METHODS	Airway responsiveness to methacholine and exhaled nitric oxide ( eNO ) were measured pre - and post-dosing .
METHODS	The effects of both treatments on the allergen-induced airway responses were compared by a paired Student 's t-test .
RESULTS	Fifteen subjects completed the study per-protocol and were included in the analysis .
RESULTS	Overall , setipiprant was well tolerated and no clinically relevant adverse events occurred .
RESULTS	Trough plasma concentrations showed a high inter-subject variability .
RESULTS	Compared with placebo , setipiprant significantly reduced the allergen-induced late asthmatic response ( LAR ) , inhibiting the area under the response vs. time curve ( AUC ( 3-10 h ) ) by on average 25.6 % ( P = 0.006 ) and significantly protected against the allergen-induced airway hyperresponsiveness ( AHR ) to methacholine ( P = 0.0029 ) .
RESULTS	There was no difference in the early asthmatic response ( EAR ) or in allergen-induced changes in eNO between treatments .
CONCLUSIONS	Setipiprant at multiple oral doses was well tolerated and reduced both the allergen-induced LAR and the associated AHR in allergic asthmatics .
CONCLUSIONS	Our findings confirm that CRTH2 may be a promising target for the treatment of allergic disorders .

###24951981
BACKGROUND	Evidences suggest that nuts consumption can improve energy metabolism .
OBJECTIVE	This study aimed to compare the effects of acute ingestion of high-oleic and conventional peanuts on appetite , food intake , and energy metabolism in overweight and obese men .
METHODS	Seventy one subjects ( 29.8 2.4 kg/m2 ) were assigned to the groups : control ( CT , n = 24 ) ; conventional peanuts ( CVP , n = 23 ) ; high-oleic peanuts ( HOP , n = 24 ) .
METHODS	Subjects consumed 56 g of peanuts ( CVP and HOP ) or control biscuits ( CT ) after overnight fasting .
METHODS	Thereafter , energy metabolism was evaluated over 200 minutes , during which diet-induced thermogenesis ( DIT ) and substrate oxidation were analyzed .
METHODS	Appetite sensation was recorded for 3 hours .
METHODS	Statistical analyses were performed using the SAS software considering 5 % as the significance level .
RESULTS	Postprandial energy expenditure and DIT were significantly higher in HOP than in CVP .
RESULTS	Substrate oxidation did not differ between groups .
RESULTS	Only HOP presented score below 100 indicating incomplete compensation .
RESULTS	CT and CVP showed a complete caloric compensation ( scores > 100 ) .
RESULTS	Regarding appetite sensation , CVP group felt less `` full '' than HOP and CT. .
RESULTS	After 3 hours , satiety score of CVP returned to baseline , whereas HOP and CT remained significantly higher .
RESULTS	Hunger scores returned to baseline in CVP and CT and they were maintained significantly lowered in HOP .
CONCLUSIONS	High-oleic peanuts contributed to higher DIT , higher sensation of fullness and incomplete compensation for energy intake compared to conventional peanuts and may be useful to dietary intervention to reduce body weight .

###25265768
BACKGROUND	Muscle relaxant is commonly used in general anesthesia to facilitate surgery .
BACKGROUND	When finishing the operation , anesthesiologists reverse the muscle relaxant with anticholinesterase , neostigmine , combined with anticholinergic for prevention of unwanted side effects from neostigmine .
BACKGROUND	The only existed anticholinergic in Thailand is atropine , which has a more rapid onset than neostigmine resulting in initial tachycardia .
BACKGROUND	Lately , we have glycopyrrolate that cause less increase in initial heart rate .
BACKGROUND	Therefore , we would like to study the effect of heart rate of the combination between atropine and glycopyrrolate to counteract the effect of neostigmine .
OBJECTIVE	Evaluate the different increase in heart rate after the reversal of muscle relaxant with neostigmine combined with atropine or glycopyrrolate plus atropine .
METHODS	The study was a randomized controlled trial study .
METHODS	Fifty-one , ASA I or II patients undergoing elective gynecological surgery under general anesthesia technique were enrolled in the present study .
METHODS	They were randomly assigned by computer-generated random sequence into two groups , control group and intervention group .
METHODS	Control group received neostigmine 2.5 mg and atropine 1.2 mg , intervention group received neostigmine 2.5 mg , glycopyrrolate 0.2 mg and atropine 0.6 mg for reversal of neuromuscular block after finishing the operation .
METHODS	Both groups received the same anesthetic agents including muscle relaxant .
METHODS	Heart rate was recorded before drugs administration and at 1 , 3 , 5 , and 7 minutes after injection .
METHODS	We also recorded heart rate in the PA CU at 0 , 15 , 30 , 45 , and 60 minutes .
METHODS	Secondary outcome was incidence of arrhythmia during the observation in PACU .
RESULTS	There was no difference in age and baseline heart rate between the two groups .
RESULTS	There was no different increase in heart rate after administration of reversal agent between control group and intervention group at any time ( p-value = 0.496 ) .
RESULTS	No incidence of significant arrhythmia in both groups .
CONCLUSIONS	There is no significant different increase in heart rate in 0.2 mg glycopyrrolate plus 0.6 mg atropine group compared to 1.2 mg atropine alone for antagonizing muscarinic effects of 2.5 mg neostigmine .
CONCLUSIONS	Therefore , atropine 0.6 mg and glycopyrrolate 0.2 mg is an alternative to antagonize muscarinic effects of neostigmine .

###24262291
OBJECTIVE	Increased DNA methylation of the metabolic regulator peroxisome proliferator-activated receptor gamma coactivator 1 alpha ( PPARGC1A ) has been reported in skeletal muscle from type 2 diabetes ( T2D ) subjects and from low birth weight ( LBW ) subjects with an increased risk of T2D .
OBJECTIVE	High-fat overfeeding increases PPARGC1A DNA methylation in muscle in a birth weight dependent manner .
OBJECTIVE	However , PPARGC1A DNA methylation in subcutaneous adipose tissue ( SAT ) in LBW subjects has not previously been investigated .
OBJECTIVE	Our objective was to determine PPARGC1A DNA methylation and mRNA expression in basal and insulin-stimulated SAT from LBW and matched normal birth weight ( NBW ) subjects during control and high-fat overfeeding .
METHODS	Nineteen young healthy men with LBW and 26 NBW controls were studied after both a 5-day high-fat overfeeding and a control diet in a randomized crossover setting .
METHODS	DNA methylation was assessed with bisulfite sequencing and mRNA expression with quantitative real-time PCR .
RESULTS	Following high-fat overfeeding , increased SAT PPARGC1A DNA methylation was observed in LBW subjects but not in NBW controls .
RESULTS	Basal SAT PPARGC1A mRNA expression was unaffected by diet and similar in the two groups .
RESULTS	However , LBW subjects showed an increased SAT PPARGC1A mRNA expression during insulin-stimulation .
RESULTS	SAT PPARGC1A methylation correlated inversely with mRNA expression during insulin-stimulation .
CONCLUSIONS	The study adds to the increasing awareness of PPARGC1A DNA methylation being flexible and influenced by high-fat overfeeding in a birth weight dependent manner with muscle and fat responding differently .
CONCLUSIONS	Further data are needed to understand the role of PPARGC1A DNA methylation in insulin resistance and developmental programming of T2D .

###24469880
BACKGROUND	The aim of the study was to compare the effects of 2 strategies of antiplatelet treatment ( i.e. , 150 mg ASA vs. 75 mg clpoidogrel ) on plasma level of inflammatory markers in type 2 diabetes mellitus ( T2DM ) patients with high platelet reactivity ( HPR ) .
METHODS	Study cohort consisted of 304 T2DM patients on chronic ASA therapy ( 75 mg per day ) participating in the Aspirin Versus/Or Clopidogrel in Aspirin-resistant Diabetics inflammation Outcomes ( AVOCADO ) study .
METHODS	Patients with HPR defined as Platelet Function Analyzer ( PFA ) -100 collagene/epinephrine closure time ( CEPI-CT ) < 193 s ( n = 80 ) were randomized to 150 mg of ASA or 75 mg of clopidogrel in 2:3 ratio , respectively .
METHODS	Concentrations of the selected inflammatory markers , including tumor necrosis factor ( TNF ) - , interleukin ( IL ) -6 , solubleCD40 ligand ( sCD40L ) , and high sensitivity C-reactive protein ( hsCRP ) , were measured and compared in both treatment groups before and after 8 weeks of treatment in both groups .
RESULTS	Out of 234 patients included into final analysis , the total of 34.2 % ( n = 80 ) patients displayed HPR , of which 14.1 % ( n = 33 ) were randomized into 150 mg of ASA group and 20.1 % ( n = 47 ) into 75 mg of clopidogrel group .
RESULTS	Treatment with clopidogrel was a positive predictor ( stepwise multiple regression analysis ) of reduction of sCD40L concentration ( odds ratio [ OR ] 4.15 ; p = 0.013 ) , while treatment with 150 mg ASA was a positive predictor of reduction of IL-6 concentration ( OR 4.38 ; p = 0.033 ) .
RESULTS	There was no statistically significant differences between clopidogrel and ASA 150 mg treatment in respect to predictive value for decreased hsCRP concentrations or increased TNF - concentrations .
CONCLUSIONS	Increasing the dose of ASA from 75 mg to 150 mg daily or switching ASA 75 mg to clopidogrel 75 mg daily may reduce concentrations of some inflammatory markers ( in particular hsCRP , IL-6 and CD40L ) in T2DM patients with HPR treated previously with 75 mg of ASA .

###25539547
OBJECTIVE	Negative-calorie diets ( NCDs ) are among the popular dieting guides for weight loss ; however , there is still little knowledge about this method .
OBJECTIVE	The present study aimed to determine the effects of a NCD supplemented with exercise on weight loss and lipid profile , and to compare its efficiency with low-calorie diets ( LCDs ) with exercise among elderly adult men with abnormal weight gain .
METHODS	Participants included sedentary men ( aged 45-75 years ) who were overweight or obese ( n = 37 ) .
METHODS	They were randomly divided into 2 groups : a group with a NCD and exercise , and a group with a LCD with exercise .
METHODS	Of all 37 participants , 30 completed the treatment .
METHODS	Weight assessment parameters , including changes in weight and body composition and blood sample tests , were performed before and 3 months after intervention .
RESULTS	All parameters decreased significantly in both groups .
RESULTS	Elevation in high-density lipoprotein ( HDL ) cholesterol levels ( P < 0.001 ) was different between the 2 groups .
RESULTS	The decline in the total cholesterol to HDL cholesterol ratio was greater in the LCD than the NCD group .
CONCLUSIONS	Contrary to expectations , both weight-loss diets were equally efficacious .

###24927691
BACKGROUND	Instruments that enable to select individuals that will benefit most from bariatric surgery ( BS ) are necessary to increase its cost-efficiency .
BACKGROUND	Our goal was to assess if intake capacity , measured with a standardized test , predicts response to BS .
METHODS	Patients with criteria for BS were randomly allocated to laparoscopic gastric bypass ( LRYGB ) or sleeve gastrectomy ( LSG ) .
METHODS	We measured caloric intake capacity before and 1 year after surgery using a standardized nutrient drink test .
METHODS	We evaluated if pre-surgery satiation could predict satiation and weight loss ( % ) 1 year after surgery using multiple regression modeling .
METHODS	Descriptive statistics are given as mean SD .
RESULTS	Fourteen women ( 48 9 years old , BMI 41 3 kg/m ( 2 ) ) were evaluated before and 11 2.6 months after surgery ( seven LRYGB , seven LSG ) .
RESULTS	Caloric intake capacity diminished after surgery ( -950 85 kcal on average [ 70 8 % decrease over basal intake capacity ] ; p = 0.002 ) and similarly in both LRYGB ( 727 % decrease ) and LSG groups ( 688 % decrease ) ; p = 0.5 .
RESULTS	There was a significant weight reduction after surgery ( -32 10 kg [ 30 8 % of total basal weight ] ) with a mean post-surgery BMI of 292 kg/m ( 2 ) .
RESULTS	The best predictive model of weight loss ( % ) after surgery ( R ( 2 ) = 89 % , p = 0.0009 ) included : BMI ( p = 0.0004 ) , surgery type ( p = 0.01 ) and pre-surgery intake capacity ( p = 0.006 ) .
RESULTS	Weight loss was higher in heavier patients and those undergoing LRYGB .
RESULTS	Patients with higher intake capacity had a poorer outcome independently of basal BMI and surgery type .
CONCLUSIONS	Caloric intake capacity , as measured by a standard nutrient drink test , helps to predict weight loss after bariatric surgery .
CONCLUSIONS	This test might be useful in algorithms of obesity treatment decision .

###25364946
OBJECTIVE	To examine the effects of Hatha yoga therapy on resilience , brain-derived neurotrophic factor ( BDNF ) levels , and salivary alpha amylase ( SAA ) activity in patients with schizophrenia-spectrum disorders .
METHODS	Single-blinded , randomized controlled study in which outpatients with schizophrenia or related psychotic disorders ( according to International Classification of Diseases , 10th Revision ) were randomly assigned to a yoga or a control group .
METHODS	November 2012-April 2013 at Yamanashi Prefectural Kita Hospital , Japan .
METHODS	In the yoga group , patients received weekly 1-hour Hatha yoga sessions , in addition to regular treatment , for 8 weeks .
METHODS	Those in the control group underwent regular treatment , which included a daycare rehabilitation program .
METHODS	Assessments included the 25-item Resilience Scale ( RS ) , Positive and Negative Syndrome Scale ( PANSS ) , plasma and salivary BDNF level , and SAA activity .
RESULTS	Fifty patients participated ( 25 in each group ; mean agestandard deviation , 50.911.3 years ; mean duration of illness , 25.010.3 years ; mean total PANSS score , 78.217.3 ) .
RESULTS	No significant differences in changes in any variable from baseline to week 8 were found between the two groups ( changes in the yoga group versus the control group : RS score , -1.619.9 versus 0.317.2 ; PANSS score , 0.512.0 versus 5.015.6 ; plasma BDNF , 41.6377.0 pg/dl versus 73.4346.0 pg/dl ; SAA , -26.272.6 kU/l versus -13.868.0 kU/l , respectively ) .
CONCLUSIONS	Adjunct yoga therapy showed no positive changes in resilience level or stress markers .
CONCLUSIONS	Duration and intensity of yoga sessions and the focus on patients with chronic illness may explain the negative observations in light of past positive evidence regarding yoga therapy .

###24378255
OBJECTIVE	The purpose of this study was to determine the impact of psychotherapy on cognitive functioning in older adults with late-life depression ( LLD ) and executive dysfunction .
METHODS	Two hundred twenty-one adults aged 60 years and older participated in a randomized clinical trial comparing the efficacy of Problem Solving Therapy ( PST ) and Supportive Therapy ( ST ) for LLD .
METHODS	Cognitive performance on seven tests of executive functioning , verbal learning , and memory was evaluated at baseline , after 12 weeks of treatment , and at 24 weeks after the completion of treatment .
RESULTS	Performance on a measure of executive functioning with a significant information processing speed component ( Stroop Color and Word Test ) improved after treatment , F ( 1 , 312 ) = 8.50 , p = 0.002 , and improved performance was associated with a reduction in depressive symptoms but not treatment type .
RESULTS	Performance on other measures of executive functioning , verbal learning , and memory did not change significantly after 12 weeks of psychotherapy treatment .
CONCLUSIONS	Our results suggest that improvements in cognitive functioning after psychotherapy treatment for depression in older adults with executive dysfunction are likely focal and not distributed across all cognitive domains .
CONCLUSIONS	Although previous analyses reported that PST was superior to ST in the treatment of depression , this analysis indicated no difference between the two treatments with regard to improvements in cognitive functioning .

###25179871
BACKGROUND	To determine whether exposure to a peer-led intervention focused on colorectal cancer ( CRC ) screening , physical activity , and multi-vitamin intake can lead to increased intentions to be screened for CRC once age eligible among adults under the age of 50 .
METHODS	Participants were residents of low-income housing sites , and CRC screening intentions were assessed at baseline and at follow-up ( approximately 2 years later ) to determine changes in screening intentions and factors associated with changes in intentions .
RESULTS	Participants ( n = 692 ) were 78.4 % female , 42.6 % Hispanic and 50.8 % black .
RESULTS	At follow-up , 51 % maintained their intention to be screened and 14.6 % newly intended to get screened .
RESULTS	Individuals newly intending to get screened were more likely to have participated in the intervention , be older , male , and born in Puerto Rico or the United States compared to those who maintained their intention not to get screened ( p < 0.05 ) .
CONCLUSIONS	Exposure to CRC prevention messages before the age of 50 can increase screening intentions among individuals who did not initially intend to get screened .
CONCLUSIONS	Peer-led interventions to promote CRC screening should include individual less than 50 years of age , as this may contribute to increased screening at the recommended age threshold .

###24242264
BACKGROUND	Men who have sex with men ( MSM ) often face socially sanctioned disapproval of sexual deviance from the heterosexual `` normal . ''
BACKGROUND	Such sexual stigma can be internalized producing a painful affective state ( i.e. , shame ) .
BACKGROUND	Although shame ( e.g. , addiction ) can predict risk-taking ( e.g. , alcohol abuse ) , sexual shame 's link to sexual risk-taking is unclear .
BACKGROUND	Socially Optimized Learning in Virtual Environments ( SOLVE ) was designed to reduce MSM 's sexual shame , but whether it does so , and if that reduction predicts HIV risk reduction , is unclear .
BACKGROUND	To test if at baseline , MSM 's reported past unprotected anal intercourse ( UAI ) is related to shame ; MSM 's exposure to SOLVE compared to a wait-list control ( WLC ) condition reduces MSM 's shame ; and shame-reduction mediates the link between WLC condition and UAI risk reduction .
METHODS	HIV-negative , self-identified African American , Latino or White MSM , aged 18-24 years , who had had UAI with a non-primary/casual partner in the past three months were recruited for a national online study .
METHODS	Eligible MSM were computer randomized to either WLC or a web-delivered SOLVE .
METHODS	Retained MSM completed baseline measures ( e.g. , UAI in the past three months ; current level of shame ) and , in the SOLVE group , viewed at least one level of the game .
METHODS	At the end of the first session , shame was measured again .
METHODS	MSM completed follow-up UAI measures three months later .
METHODS	All data from 921 retained MSM ( WLC condition , 484 ; SOLVE condition , 437 ) were analyzed , with missing data multiply imputed .
RESULTS	At baseline , MSM reporting more risky sexual behaviour reported more shame ( r s = 0.21 ; p < 0.001 ) .
RESULTS	MSM in the SOLVE intervention reported more shame reduction ( M = -0.08 ) than MSM in the control condition ( M = 0.07 ; t ( 919 ) = 4.24 ; p < 0.001 ) .
RESULTS	As predicted , the indirect effect was significant ( point estimate -0.10 , 95 % bias-corrected CI [ -0.01 to -0.23 ] such that participants in the SOLVE treatment condition reported greater reductions in shame , which in turn predicted reductions in risky sexual behaviour at follow-up .
RESULTS	The direct effect , however , was not significant .
CONCLUSIONS	SOLVE is the first intervention to : ( 1 ) significantly reduce shame for MSM ; and ( 2 ) demonstrate that shame-reduction , due to an intervention , is predictive of risk ( UAI ) reduction over time .

###25043068
BACKGROUND	It is unclear whether the effect of video-assisted thoracoscopic surgery ablation is better than catheter ablation on paroxysmal atrial fibrillation ( PAF ) or not .
BACKGROUND	This study aimed to compare the effects of catheter ablation and video-assisted thoracoscopic surgery ablation on PAF .
METHODS	From March 2008 to March 2012 , 138 consecutive patients with PAF were randomly assigned to receive either video-assisted thoracoscopic surgery ablation ( thoracoscopy group , n = 66 ) or the traditional catheter ablation ( catheter group , n = 72 ) .
RESULTS	No patient died during the study and all were successfully followed and included in analysis .
RESULTS	There were no significant differences in clinical and echocardiographic characteristics between the two groups .
RESULTS	All patients were evaluated at 1 week , 1 month , 3 months , 6 months , and 12 months after discharge by physical examination and related laboratory tests .
RESULTS	Preoperative left atrium dimensions ( LADs ) of the recurrent AF were ( 47 4 ) mm in the thoracoscopy group and ( 46 8 ) mm in the catheter group , whereas the LADs were ( 40 5 ) and ( 39 9 ) mm , respectively , in non-recurrent PAF .
CONCLUSIONS	The short-term outcome of video-assisted thoracoscopic surgery ablation is safe and effective ; and the indications are wider than those for catheter ablation .
CONCLUSIONS	The larger left atrium diameter is related to the recurrence of atrial fibrillation .

###24673668
OBJECTIVE	The objective was to determine if use of ultrasound ( US ) by emergency physicians ( EPs ) to localize spinal landmarks improves the performance of lumbar puncture ( LP ) .
METHODS	This was a prospective , randomized , controlled study conducted in a county teaching hospital .
METHODS	Subjects , adults 18years of age or older who were to receive LPs for routine clinical care in the emergency department ( ED ) , were randomized either to undergo US localization of the puncture site or to have the puncture site determined by palpation of spinal landmarks .
METHODS	Primary outcomes were the number of needle insertion attempts and success of the procedure .
METHODS	Secondary outcomes were pain associated with the procedure , time to perform the procedure , number of traumatic taps , and patient satisfaction with the procedure .
RESULTS	One-hundred patients were enrolled in the study , with 50 in each study group .
RESULTS	There were no significant differences between the two groups in terms of age , sex , body mass index ( BMI ) , indication for LP , or ease of palpation of landmarks .
RESULTS	For both primary outcomes and secondary outcomes there were no significant differences between those undergoing US localization and those with palpation alone .
CONCLUSIONS	These data do not suggest any advantage to the routine use of US localization for LP insertion , although further study may be warranted to look for benefit in the difficult to palpate or obese patient subgroups .

###24698578
OBJECTIVE	One of the most common joint dislocations presented to the emergency department ( ED ) is anterior shoulder dislocation ( ASD ) .
OBJECTIVE	Various techniques for the treatment of this abnormality have been suggested .
OBJECTIVE	In this study , we evaluated the efficacy and success rate of modified scapular manipulation ( MSM ) as a painless procedure compared to traction-countertraction ( TCT ) for reduction of ASD .
METHODS	Patients with ASD who were presented to ED of Baqiyatallah Hospital , Tehran during 2011 were included .
METHODS	They were randomly divided into MSM group or TCT group and then pain at reduction , time of reduction , duration of hospitalization , and success rate were compared .
METHODS	In TCT group , reduction was performed using sedative and antipain medications .
RESULTS	Ninety seven patients ( 81.6 % male ) with a mean age of 34.15 years13 .48 years were studied .
RESULTS	The reduction time between both groups showed a significant difference ( 470.88 seconds227 .59 seconds for TCT group , 79.35 seconds82 .49 seconds for MSM group , P < 0.001 ) .
RESULTS	The success rate in MSM group in the first and second effort were 89 % and 97 % whereas 73 % and 100 % in the TCT group respectively ( P < 0.001 ) .
CONCLUSIONS	It seems that the manipulation technique can be more successful than the TCT method at the first effort whilst the second effort has the opposite results .
CONCLUSIONS	Also MSM can be safer , cheaper and more acceptable for patients than TCT as a standard traditional method .

###25303507
OBJECTIVE	The purpose of this clinical study was to compare the chair time and degree of patient satisfaction after use of the Isolite system ( IS ) versus rubber dam ( RD ) during the application of pit and fissure sealants .
METHODS	The patients included in this study ranged from seven to 16 years old .
METHODS	In each subject , pit and fissure sealants were applied to one permanent molar in each quadrant .
METHODS	IS dental isolation was used on one side ; RD isolation was used on the other side .
METHODS	Chair time was assessed using a stopwatch , and patient acceptance was evaluated using a questionnaire .
RESULTS	Forty-two subjects ( 23 females and 19 males ) were enrolled in the study .
RESULTS	The average chair time was 19.36 minutes for the application of pit and fissure sealants on the RD side ; average chair time was 10 minutes for the IS side ( P < .001 ) .
RESULTS	Sixty-nine percent of the subjects were more comfortable using IS , while 31 percent found RD to be more comfortable ( P = .02 ) .
CONCLUSIONS	Isolite is a viable alternative to the conventional rubber dam .
CONCLUSIONS	The use of Isolite is associated with reduced chair time and greater patient satisfaction .

###25836004
BACKGROUND	The objective of this study was to determine the Hounsfield unit ( HU ) changes in the alveolar bone and root surfaces during controlled canine retractions .
METHODS	Eighteen maxillary canine retraction patients were selected for this split-mouth design clinical trial .
METHODS	The canines in each patient were randomly assigned to receive either translation or controlled tipping treatment .
METHODS	Pretreatment and posttreatment cone-beam computed tomography scans of each patient were used to determine tooth movement direction and HU changes .
METHODS	The alveolar bone and root surface were divided into 108 divisions , respectively .
METHODS	The HUs in each division were measured .
METHODS	Mixed-model analysis of variance was applied to test the HU change distribution at the P < 0.05 significance level .
RESULTS	The HU changes varied with the directions relative to the canine movement .
RESULTS	The HU reductions occurred at the root surfaces .
RESULTS	Larger reductions occurred in the divisions that were perpendicular to the moving direction .
RESULTS	However , HUs decreased in the alveolar bone in the moving direction .
RESULTS	The highest HU reduction was at the coronal level .
CONCLUSIONS	HU reduction occurs on the root surface in the direction perpendicular to tooth movement and in the alveolar bone in the direction of tooth movement when a canine is retracted .

###24684808
BACKGROUND	Over fifty percent of stroke patients experience chronic arm hand performance problems , compromising independence in daily life activities and quality of life .
BACKGROUND	Task-oriented training may improve arm hand performance after stroke , whereby augmented therapy may lead to a better treatment outcome .
BACKGROUND	Technology-supported training holds opportunities for increasing training intensity .
BACKGROUND	However , the effects of robot-supported task-oriented training with real life objects in stroke patients are not known to date .
BACKGROUND	The aim of the present study was to investigate the effectiveness and added value of the Haptic Master robot combined with task-oriented arm hand training in chronic stroke patients .
METHODS	In a single-blind randomized controlled trial , 22 chronic stroke patients were randomly allocated to receive either task-oriented robot-assisted arm-hand training ( experimental group ) or task-oriented non-robotic arm-hand training ( control group ) .
METHODS	For training , the T-TOAT ( Technology-supported Task-Oriented Arm Training ) method was applied .
METHODS	Training was provided during 8 weeks , 4 times/week , 2 30 min/day .
RESULTS	A significant improvement after training on the Action Research Arm Test ( ARAT ) was demonstrated in the experimental group ( p = 0.008 ) .
RESULTS	Results were maintained until 6 months after cessation of the training .
RESULTS	On the perceived performance measure ( Motor Activity Log ( MAL ) ) , both , the experimental and control group improved significantly after training ( control group p = 0.008 ; experimental group p = 0.013 ) .
RESULTS	The improvements on MAL in both groups were maintained until 6 months after cessation of the training .
RESULTS	With regard to quality of life , only in the control group a significant improvement after training was found ( EuroQol-5D p = 0.015 , SF-36 physical p = 0.01 ) .
RESULTS	However , the improvement on SF-36 in the control group was not maintained ( p = 0.012 ) .
RESULTS	No between-group differences could be demonstrated on any of the outcome measures .
CONCLUSIONS	Arm hand performance improved in chronic stroke patients , after eight weeks of task oriented training .
CONCLUSIONS	The use of a Haptic Master robot in support of task-oriented arm training did not show additional value over the video-instructed task-oriented exercises in highly functional stroke patients .
BACKGROUND	Current Controlled Trials ISRCTN82787126 .

###24892113
OBJECTIVE	To compare the clinical and radiological outcomes of two implant designs with different prosthetic interfaces and neck configurations .
METHODS	Thirty-four partially edentate patients randomly received at least one NobelActive implant ( Nobel Biocare , Gteborg , Sweden ) with back-tapered collar , internal conical connection and platform shifting design , and one NobelSpeedy implant ( Nobel Biocare ) with external hexagon and flat-to-flat implant-abutment interface according to a split-mouth design .
METHODS	Follow-up continued to 3 years post-loading .
METHODS	The primary outcome measures were the success rates of the implants and prostheses , and the occurrence of any surgical and prosthetic complications during the entire follow-up .
METHODS	Secondary outcome measures were : horizontal and vertical peri-implant marginal bone level ( MBL ) changes , resonance frequency analysis values at implant placement and loading ( 4 months ) , sulcus bleeding index ( SBI ) and plaque score ( PS ) .
RESULTS	No drop-out occurred .
RESULTS	No implants and prostheses failures were observed to the 3-year follow-up .
RESULTS	MBL changes were statistically significant different with better results for the NobelActive implants for both horizontal and vertical measurements ( P = 0.000 ) .
RESULTS	After 3 years post-loading , the NobelActive implants underwent a mean vertical bone resorption of 0.66 mm , compared with 1.25 mm for the NobelSpeedy Groovy implants ( P = 0.000 ) ; the mean horizontal bone resorption was 0.19 mm for the NobelActive implants and 0.60 mm for the NobelSpeedy Groovy implants ( P = 0.000 ) .
RESULTS	A high ISQ value was found for both implants , and no statistically significant difference was found for ISQ mean values between interventions ( P = 0.941 at baseline ; P = 0.454 at implantabutment connection ; P = 0.120 at prosthesis delivery ) .
RESULTS	All implants showed good periodontal health at the 3-year-in-function visit , with no significant differences between groups .
CONCLUSIONS	The results of this research suggest that in well-maintained patients , the MBL changes could be affected by the different implant design .
CONCLUSIONS	After 4 months of unloaded healing , as well as after 3 years in function , both implants provided good results , however vertical and horizontal bone loss had statistically significant differences between the two groups ( difference of 0.58 0.10 mm for the vertical MBL , and 0.4 0.05 mm for the horizontal MBL ) , with lower values in the Nobel Active implants , compared to the NobelSpeedy Groovy implants .

###25556427
BACKGROUND	Unopposed estrogen has a central role in development of endometrial benign , premalignant and malignant lesions .
BACKGROUND	The aim of this study was to evaluate the anti-estrogenic effect of metformin on endometrial histology in comparison with progesterone .
METHODS	A total of 43 patients who were referred to our center for abnormal uterine bleeding and had a histologic diagnosis were disordered proliferative endometrium or simple endometrial hyperplasia were included and randomly distributed in two groups treated with metformin ( 500mg Bid ) or megestrol ( 40mg daily ) , respectively , for three months .
METHODS	After this period the patients were evaluated by another endometrial biopsy to assess the impact of the two drugs in restoring normal endometrial histology .
RESULTS	Our findings revealed that metformin could induce endometrial atrophy in 21 out of 22 patients ( 95.5 % ) while this positive response was achieved in only 13 out of 21 patients ( 61.9 % ) in the megstrol group .
RESULTS	In addition two low grade endometrial carcinomas in the metformin group responded very well .
CONCLUSIONS	We conclude that metformin could be used as an effective antiestrogenic agent in control of abnormal endometrial proliferative disorders .

###24905061
BACKGROUND	Thiazolidinediones are associated with increased fractures in type 2 diabetes mellitus ( T2D ) .
BACKGROUND	One explanation is that activation of peroxisome proliferator-activated receptor - expression alters bone remodeling cells .
OBJECTIVE	To investigate whether osteoclast and osteogenic precursor cells are altered by rosiglitazone ( RSG ) treatment in T2D as compared to metformin ( MET ) treatment .
METHODS	A randomized controlled trial of RSG or MET for 52 weeks , followed by 24 weeks of MET .
METHODS	Data were generated at a tertiary care center .
METHODS	Seventy-three T2D postmenopausal women participated .
METHODS	Peripheral blood mononuclear cells were isolated and cultured with receptor activator of nuclear factor B ligand and stained for tartrate-resistant acid phosphatase to measure circulating osteoclast precursors .
METHODS	Peripheral blood mononuclear cells were also characterized for osteogenic , endothelial , and calcification markers by flow cytometry with the ligands osteocalcin ( OCN ) , CD34 , and CD 146 .
RESULTS	Tartrate-resistant acid phosphatase-positive cells increased between weeks 0 and 52 ( RSG , 2.9 2 to 14.0 3 U/L , P = .001 ; MET , 3.3 2 to 16.7 2 U/L , P = .001 ) , increasing further in the RSG group after changing to MET ( to 26.5 5 U/L , P = .05 vs wk 52 ) .
RESULTS	With RSG , OCN + cells with CD34 but without CD146 fell from weeks 0 to 52 ( 20.1 1 % to 15.5 2 % ; P = .03 ) , remaining stable through week 76 .
RESULTS	The OCN + cells lacking both CD34 and CD146 increased from weeks 0 to 52 ( 67.3 2 to 74.4 2 % ; P = .02 ) , but returned to baseline after switching to MET .
CONCLUSIONS	In postmenopausal women with T2D , circulating osteoclast precursor cells increase with both RSG and MET , and increase further when switching from RSG to MET .
CONCLUSIONS	Subpopulations of cells that may be involved in the osteogenic lineage pathway are also altered with RSG .
CONCLUSIONS	Further work is necessary to elucidate how these changes may relate to fracture risk .

###25239292
OBJECTIVE	This study was designed to assess the knowledge acquired by very young children ( < 6 years ) trained by their own teachers at nursery school .
OBJECTIVE	This comparative study assessed the effect of training before the age of 6 years compared with a group of age-matched untrained children .
METHODS	Some schoolteachers were trained by emergency medical teams to perform basic first aid .
METHODS	Eighteen classes comprising 315 pupils were randomly selected : nine classes of trained pupils ( cohort C1 ) and nine classes of untrained pupils ( cohort C2 ) .
METHODS	The test involved observing and describing three pictures and using the phone to call the medical emergency centre .
METHODS	Assessment of each child was based on nine criteria , and was performed by the teacher 2 months after completion of first aid training .
RESULTS	This study concerned 285 pupils : 140 trained and 145 untrained .
RESULTS	The majority of trained pupils gave the expected answers for all criteria and reacted appropriately by assessing the situation and alerting emergency services ( 55.7-89 .3 % according to the questions ) .
RESULTS	Comparison of the two groups revealed a significantly greater ability of trained pupils to describe an emergency situation ( p < 0.005 ) and raise the alert ( p < 0.0001 ) .
CONCLUSIONS	This study shows the ability of very young children to assimilate basic skills as taught by their own schoolteachers .

###24716641
BACKGROUND	Existing studies of risk factors for physical impairments in acute lung injury ( ALI ) survivors were potentially limited by single-center design or relatively small sample size .
OBJECTIVE	To evaluate risk factors for three measures of physical impairments commonly experienced by survivors of ALI in the first year after hospitalization .
METHODS	A prospective , longitudinal study of 6 - and 12-month physical outcomes ( muscle strength , 6-minute-walk distance , and Short Form [ SF ] -36 Physical Function score ) for 203 survivors of ALI enrolled from 12 hospitals participating in the ARDS Network randomized trials .
METHODS	Multivariable regression analyses evaluated the independent association of critical illness-related variables and intensive care interventions with impairments in each physical outcome measure , after adjusting for patient demographics , comorbidities , and baseline functional status .
RESULTS	At 6 and 12 months , respectively , mean ( SD ) values for strength ( presented as proportion of maximum strength score evaluated using manual muscle testing ) was 92 % ( 8 % ) and 93 % ( 9 % ) , 6-minute-walk distance ( as percent-predicted ) was 64 % ( 22 % ) and 67 % ( 26 % ) , and SF-36 Physical Function score ( as percent-predicted ) was 61 % ( 36 % ) and 67 % ( 37 % ) .
RESULTS	After accounting for patient baseline status , there was significant association and statistical interaction of mean daily dose of corticosteroids and intensive care unit length of stay with impairments in physical outcomes .
CONCLUSIONS	Patients had substantial impairments , from predicted values , for 6-minute-walk distance and SF-36 Physical Function outcome measures .
CONCLUSIONS	Minimizing corticosteroid dose and implementing existing evidence-based methods to reduce duration of intensive care unit stay and associated patient immobilization may be important interventions for improving ALI survivors ' physical outcomes .

###24299218
BACKGROUND	Aortic valve stenosis is one of the most common heart diseases in older patients .
BACKGROUND	Nowadays , surgical aortic valve replacement is the ` gold standard ' treatment for this pathology and the most implanted prostheses are biological ones .
BACKGROUND	The three most implanted bovine bioprostheses are the Trifecta valve ( St. Jude Medical , Minneapolis , MN , USA ) , the Mitroflow valve ( Sorin Group , Saluggia , Italy ) , and the Carpentier-Edwards Magna Ease valve ( Edwards Lifesciences , Irvine , CA , USA ) .
BACKGROUND	We propose a randomized trial to objectively assess the hemodynamic performances of these bioprostheses .
METHODS	First , we will measure the aortic annulus diameter using CT-scan , echocardiography and by direct sizing in the operating room after native aortic valve resection .
METHODS	The accuracy of information , in terms of size and spatial dimensions of each bioprosthesis provided by manufacturers , will be checked .
METHODS	Their hemodynamic performances will be assessed postoperatively at the seventh day and the sixth month after surgery .
CONCLUSIONS	This prospective controlled randomized trial aims to verify and compare the hemodynamic performances and the sizing of these three bioprostheses .
CONCLUSIONS	The data obtained may help surgeons to choose the best suitable bioprosthesis according to each patient 's morphological characteristics .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01522352 .

###25316860
BACKGROUND	Polio eradication efforts have been hampered by low responses to trivalent oral poliovirus vaccine ( tOPV ) in some developing countries .
BACKGROUND	Since stomach acidity may neutralize vaccine viruses , we assessed whether administration of a buffer solution could improve the immunogenicity of tOPV .
METHODS	Healthy infants 4-6 weeks old in Sylhet , Bangladesh , were randomized to receive tOPV with or without a sodium bicarbonate and sodium citrate buffer at age 6 , 10 , and 14 weeks .
METHODS	Levels of serum neutralizing antibodies for poliovirus types 1 , 2 , and 3 were measured before and after vaccination , at 6 and 18 weeks of age , respectively .
RESULTS	Serologic response rates following 3 doses of tOPV for buffer recipients and control infants were 95 % and 88 % ( P = .065 ) , respectively , for type 1 poliovirus ; 95 % and 97 % ( P = .543 ) , respectively , for type 2 poliovirus ; and 90 % and 89 % ( P = .79 ) , respectively , for type 3 poliovirus .
CONCLUSIONS	Administration of a buffer solution prior to vaccination was not associated with statistically significant increases in the immune response to tOPV ; however , a marginal 7 % increase ( P = .065 ) in serologic response to poliovirus type 1 was observed .
BACKGROUND	NCT01579825 .

###26308684
BACKGROUND	Data on the effect of initial combination therapy with ambrisentan and tadalafil on long-term outcomes in patients with pulmonary arterial hypertension are scarce .
METHODS	In this event-driven , double-blind study , we randomly assigned , in a 2:1:1 ratio , participants with World Health Organization functional class II or III symptoms of pulmonary arterial hypertension who had not previously received treatment to receive initial combination therapy with 10 mg of ambrisentan plus 40 mg of tadalafil ( combination-therapy group ) , 10 mg of ambrisentan plus placebo ( ambrisentan-monotherapy group ) , or 40 mg of tadalafil plus placebo ( tadalafil-monotherapy group ) , all administered once daily .
METHODS	The primary end point in a time-to-event analysis was the first event of clinical failure , which was defined as the first occurrence of a composite of death , hospitalization for worsening pulmonary arterial hypertension , disease progression , or unsatisfactory long-term clinical response .
RESULTS	The primary analysis included 500 participants ; 253 were assigned to the combination-therapy group , 126 to the ambrisentan-monotherapy group , and 121 to the tadalafil-monotherapy group .
RESULTS	A primary end-point event occurred in 18 % , 34 % , and 28 % of the participants in these groups , respectively , and in 31 % of the pooled-monotherapy group ( the two monotherapy groups combined ) .
RESULTS	The hazard ratio for the primary end point in the combination-therapy group versus the pooled-monotherapy group was 0.50 ( 95 % confidence interval [ CI ] , 0.35 to 0.72 ; P < 0.001 ) .
RESULTS	At week 24 , the combination-therapy group had greater reductions from baseline in N-terminal pro-brain natriuretic peptide levels than did the pooled-monotherapy group ( mean change , -67.2 % vs. -50.4 % ; P < 0.001 ) , as well as a higher percentage of patients with a satisfactory clinical response ( 39 % vs. 29 % ; odds ratio , 1.56 [ 95 % CI , 1.05 to 2.32 ] ; P = 0.03 ) and a greater improvement in the 6-minute walk distance ( median change from baseline , 48.98 m vs. 23.80 m ; P < 0.001 ) .
RESULTS	The adverse events that occurred more frequently in the combination-therapy group than in either monotherapy group included peripheral edema , headache , nasal congestion , and anemia .
CONCLUSIONS	Among participants with pulmonary arterial hypertension who had not received previous treatment , initial combination therapy with ambrisentan and tadalafil resulted in a significantly lower risk of clinical-failure events than the risk with ambrisentan or tadalafil monotherapy .
CONCLUSIONS	( Funded by Gilead Sciences and GlaxoSmithKline ; AMBITION ClinicalTrials.gov number , NCT01178073 . )

###25408218
BACKGROUND	With the rise in the ageing population and absence of a cure for dementia , cost-effective prevention strategies for those ` at risk ' of dementia including those with depression and/or mild cognitive impairment are urgently required .
OBJECTIVE	This study evaluated the efficacy of a multifaceted Healthy Brain Ageing Cognitive Training ( HBA-CT ) program for older adults ` at risk ' of dementia .
METHODS	Using a single-blinded design , 64 participants ( mean age = 66.5 years , SD = 8.6 ) were randomized to an immediate treatment ( HBA-CT ) or treatment-as-usual control arm .
METHODS	The HBA-CT intervention was conducted twice-weekly for seven weeks and comprised group-based psychoeducation about cognitive strategies and modifiable lifestyle factors pertaining to healthy brain ageing , and computerized cognitive training .
RESULTS	In comparison to the treatment-as-usual control arm , the HBA-CT program was associated with improvements in verbal memory ( p = 0.03 ) , self-reported memory ( p = 0.03 ) , mood ( p = 0.01 ) , and sleep ( p = 0.01 ) .
RESULTS	While the improvements in memory ( p = 0.03 ) and sleep ( p = 0.02 ) remained after controlling for improvements in mood , only a trend in verbal memory improvement was apparent after controlling for sleep .
CONCLUSIONS	The HBA-CT program improves cognitive , mood , and sleep functions in older adults ` at risk ' of dementia , and therefore offers promise as a secondary prevention strategy .

###24625516
BACKGROUND	A recombinant cysteine proteinase from Leishmania ( Leishmania ) infantum chagasi ( rLdccys1 ) was previously shown to induce protective immune responses against murine and canine visceral leishmaniasis .
BACKGROUND	These findings encouraged us to use rLdccys1 in the immunotherapy of naturally infected dogs from Teresina , Piau , a region of high incidence of visceral leishmaniasis in Brazil .
RESULTS	Thirty naturally infected mongrel dogs displaying clinical signs of visceral leishmaniasis were randomly divided in three groups : one group received three doses of rLdccys1 in combination with the adjuvant Propionibacterium acnes at one month interval between each dose ; a second group received three doses of P. acnes alone ; a third group received saline .
RESULTS	The main findings were : 1 ) dogs that received rLdccys1 with P. acnes did not display increase of the following clinical signs : weight loss , alopecia , onychogryphosis , cachexia , anorexia , apathy , skin lesions , hyperkeratosis , ocular secretion , and enlarged lymph nodes ; they also exhibited a significant reduction in the spleen parasite load in comparison to the control dogs ; 2 ) rLdccys1-treated dogs exhibited a significant delayed type cutaneous hypersensitivity elicited by the recombinant antigen , as well as high IgG2 serum titers and low IgG1 serum titers ; sera from rLdccys1-treated dogs also contained high IFN - and low IL-10 concentrations ; 3 ) control dogs exhibited all of the clinical signs of visceral leishmaniasis and had low serum IgG2 and IFN - levels and high concentrations of IgG1 and IL-10 ; 4 ) all of the dogs treated with rLdccys1 were alive 12 months after treatment , whereas dogs which received either saline or P. acnes alone died within 3 to 7 months .
CONCLUSIONS	These findings illustrate the potential use of rLdccys1 as an additional tool for the immunotherapy of canine visceral leishmaniasis and support further studies designed to improve the efficacy of this recombinant antigen for the treatment of this neglected disease .

###25036048
BACKGROUND	To evaluate the safety and immunogenicity of the thiomersal-free ( TF ) and thiomersal-containing ( TC ) formulations of Hepavax-Gene in healthy Vietnamese neonates .
METHODS	A single-blind , randomized , controlled study in Ho Chi Minh City , Vietnam .
METHODS	Healthy infants , born after a normal gestational period ( 37-42 weeks ) to hepatitis B surface antigen-negative mothers , participated in the study .
METHODS	Subjects were randomly allocated in a 1:1 ratio to receive either Hepavax-Gene TC or Hepavax-Gene TF using a standard 0-1-6-month administration schedule .
METHODS	Postvaccination blood samples were taken at months 1 , 6 and 7 .
METHODS	Parents/legal guardians recorded solicited local and systemic adverse events up to 4 weeks after each vaccination .
RESULTS	Very high proportions of subjects were seroprotected .
RESULTS	Seroprotection rates at 1 , 6 and 7 months were all above 95 % using a 10 IU/L cutoff , and were mostly above 90 % using a 100 IU/L cutoff .
RESULTS	Seroprotection rates between the 2 formulations were equivalent within a 5 % margin for either cutoff titer both after 6 and 7 months .
RESULTS	There were no significant differences in the number of adverse events reported between the 2 formulations .
RESULTS	Safety results were in line with previous reports for Hepavax-Gene .
RESULTS	Both formulations of Hepavax-Gene were well tolerated .
RESULTS	There were no local adverse events reported in the TF group .
RESULTS	No serious adverse events were reported during the study .
CONCLUSIONS	The thiomersal-free formulation of Hepavax-Gene was noninferior to the thiomersal-containing formulation of Hepavax-Gene in terms of immunogenicity .
CONCLUSIONS	There was evidence that the thiomersal-free vaccine was associated with fewer local adverse events .

###25176266
OBJECTIVE	To investigate the dynamics of lipid metabolism , C-reactive protein ( CRP ) , lipid peroxidation and antioxidant system in lacunar infarction ( LI ) in chronic cerebral ischemia .
METHODS	Two groups of patients were studied .
METHODS	The main group included 31 patients who received intravenous laser irradiation of blood ( ILIB ) with semiconductor laser ( wavelength - 0.67 microns , the power output - 3-2 mW ) in addition to standard treatment .
METHODS	Patients of the control group ( n = 22 ) received only standard treatment .
RESULTS	A statistically significant decrease in total cholesterol levels to normal values due to the significant reduction of the content of antiatherogenic fraction of cholesterol ( high-density lipoprotein and atherogenic low-density lipoprotein cholesterol ) was found in the main group after treatment .
RESULTS	The reduction in atherogenic cholesterol fractions in both groups was associated with the decrease in apolipoprotein B level .
RESULTS	The level of CRP was higher than normal in the main and control groups of patients before and after treatment , which indicated the risk of vascular diseases in patients with LI .
RESULTS	After treatment , superoxide dismutase activity returned to normal values .
RESULTS	In patients of the main group , the catalase activity increased while the level of reduced glutathione did not change and lipid peroxidation products remained on the high level .
CONCLUSIONS	Additional antioxidant therapy is needed for these patients .

###24281606
BACKGROUND	Clinical trials have shown the effectiveness of systemic and local insulin therapy in improving wound healing .
BACKGROUND	Diabetic wounds remain a challenge for healthcare providers .
BACKGROUND	Impaired angiogenesis and reduced granulation tissue formation contribute to inadequate wound healing .
BACKGROUND	The aim of this study was to investigate the effect of local insulin administration in acute and chronic diabetic wounds .
METHODS	Eight diabetic patients presenting with full-thickness wounds , of different causes , were included in this study .
METHODS	Five wounds were due to necrobiosis , one to trauma , and two to postneoplasm resection .
METHODS	All wounds were treated with regular bedside treatment .
METHODS	In addition , half of the wound surface was treated with insulin and the other half did not receive insulin .
METHODS	Thermographic and biopsy specimens of the two sides were obtained on days 0 and 14 .
METHODS	The presence of fibrosis , change in temperature , and amount of blood were evaluated .
RESULTS	Significant differences in the number of vessels were observed on the insulin-treated side ( 96 47 ) when compared with the no-insulin side ( 32.88 45 ) ( p < 0.026 ) .
RESULTS	The percentage of fibrosis ( insulin : 44.42 30.42 percent versus no insulin : 12.38 36.17 percent ; p < 0.047 ) and the mean temperature ( insulin : 1.27 1.12 C versus no-insulin : 0.13 1.22 C ; p < 0.001 ) were also significantly different between sides .
RESULTS	No adverse events related to the study occurred .
CONCLUSIONS	The use of local insulin improves the formation of new blood vessels , increases fibrosis , and correlates with increased temperature .
METHODS	Therapeutic , II .

###25705822
BACKGROUND	The prevalence of peanut allergy among children in Western countries has doubled in the past 10 years , and peanut allergy is becoming apparent in Africa and Asia .
BACKGROUND	We evaluated strategies of peanut consumption and avoidance to determine which strategy is most effective in preventing the development of peanut allergy in infants at high risk for the allergy .
METHODS	We randomly assigned 640 infants with severe eczema , egg allergy , or both to consume or avoid peanuts until 60 months of age .
METHODS	Participants , who were at least 4 months but younger than 11 months of age at randomization , were assigned to separate study cohorts on the basis of preexisting sensitivity to peanut extract , which was determined with the use of a skin-prick test -- one consisting of participants with no measurable wheal after testing and the other consisting of those with a wheal measuring 1 to 4 mm in diameter .
METHODS	The primary outcome , which was assessed independently in each cohort , was the proportion of participants with peanut allergy at 60 months of age .
RESULTS	Among the 530 infants in the intention-to-treat population who initially had negative results on the skin-prick test , the prevalence of peanut allergy at 60 months of age was 13.7 % in the avoidance group and 1.9 % in the consumption group ( P < 0.001 ) .
RESULTS	Among the 98 participants in the intention-to-treat population who initially had positive test results , the prevalence of peanut allergy was 35.3 % in the avoidance group and 10.6 % in the consumption group ( P = 0.004 ) .
RESULTS	There was no significant between-group difference in the incidence of serious adverse events .
RESULTS	Increases in levels of peanut-specific IgG4 antibody occurred predominantly in the consumption group ; a greater percentage of participants in the avoidance group had elevated titers of peanut-specific IgE antibody .
RESULTS	A larger wheal on the skin-prick test and a lower ratio of peanut-specific IgG4 : IgE were associated with peanut allergy .
CONCLUSIONS	The early introduction of peanuts significantly decreased the frequency of the development of peanut allergy among children at high risk for this allergy and modulated immune responses to peanuts .
CONCLUSIONS	( Funded by the National Institute of Allergy and Infectious Diseases and others ; ClinicalTrials.gov number , NCT00329784 . )

###25491726
BACKGROUND	Health care professionals in several countries are searching for alternatives to acute hospitalization .
BACKGROUND	In Hallingdal , Norway , selected acute patients are admitted to a community hospital .
BACKGROUND	The aim of this study was to analyse whether acute admission to a community hospital as an alternative to a general hospital had any positive or negative health consequences for the patients .
METHODS	Patients intended for acute admission to the local community hospital were asked to join a randomized controlled trial .
METHODS	One group of the enrolled patients was admitted as planned ( group 1 , n = 33 ) , while another group was admitted to the general hospital ( group 2 , n = 27 ) .
METHODS	Health outcomes were measured by the Nottingham Extended Activity of Daily Living Questionnaire and by collection of data concerning specialist and community health care services in a follow-up year .
RESULTS	After one year , no statistical significant differences in the level of daily function was found between group 1 ( admissions to the community hospital ) and group 2 ( admissions to the general hospital ) .
RESULTS	Group 1 had recorded fewer in-patient days at hospitals and nursing homes , as well as lower use of home nursing , than group 2 .
RESULTS	For outpatient referrals , the trend was the opposite .
RESULTS	However , the differences between the two groups were not at a 5 % level of statistical significance .
CONCLUSIONS	No statistical significant differences at a 5 % level were found related to health consequences between the two randomized groups .
CONCLUSIONS	The study however , indicates a consistent trend of health benefits rather than risk from acute admissions to a community hospital , as compared to the general hospital .
CONCLUSIONS	Emergency admission and treatment at a lower-level facility than the hospital thus appears to be a feasible solution for a selected group of patients .
BACKGROUND	ClinicalTrials.gov NCT01069107 .
BACKGROUND	Registered 2 April 2010 .

###25300266
BACKGROUND	Obesity in pregnancy is associated with fetal macrosomia , a raised neonatal fat mass and an increased risk of obesity and poor metabolic health in childhood which persists into adulthood .
BACKGROUND	The offspring of obese women are more likely to be obese than the offspring of lean women when they become pregnant themselves , perpetuating a cycle of obesity and its associated negative metabolic consequences .
BACKGROUND	Increasing physical activity during pregnancy could improve insulin sensitivity and reduce the risk of maternal and offspring adverse outcomes .
BACKGROUND	The UK Pregnancy Better Eating and Activity Trial ( UPBEAT ) is a trial of a complex intervention designed to improve pregnancy outcomes through dietary changes and physical activity .
BACKGROUND	Data from the pilot trial of 183 women were available for analysis .
BACKGROUND	The relationship between the time spent at different physical activity levels and maternal and infant pregnancy outcomes was examined .
CONCLUSIONS	Strong evidence exists that physical activity improves insulin sensitivity in non-pregnant populations , and lifestyle interventions of proven effectiveness in non-pregnant populations have been developed .
CONCLUSIONS	Women who are active in pregnancy demonstrate better glucose control and favourable pregnancy outcomes .
CONCLUSIONS	There is a lack of effective interventions to support obese pregnant women to be physically active .
CONCLUSIONS	No difference was detected in objectively measured physical activity between women randomised to the intervention and control arms of the UPBEAT pilot trial .
CONCLUSIONS	Light-intensity physical activity was lower in early pregnancy in women who delivered macrosomic infants .
CONCLUSIONS	Maternal sedentary time at 35-36 weeks ' gestation was positively associated and moderate-intensity physical activity was inversely associated with neonatal abdominal circumference .
CONCLUSIONS	Maternal physical activity is associated with infant birth weight and abdominal circumference and is an appropriate target for intervention to improve infant outcomes .
CONCLUSIONS	The challenge remains to develop an effective intervention to support obese pregnant women to be physically active .

###25678778
BACKGROUND	In type 2 diabetes mellitus , fixed-dose combination ( FDC ) can provide the complementary benefits of correction of multiple pathophysiologic defects such as dysfunctions in glycemic or metabolic control while improving compliance compared with separate tablets taken together .
BACKGROUND	The objective of the study reported here was to compare the pharmacodynamic ( PD ) , pharmacokinetic ( PK ) , and tolerability profiles of gemigliptin and extended-release metformin ( metformin XR ) between FDC and separate tablets .
METHODS	A randomized , open-label , single-dose , two-way , two-period , crossover study was conducted in 28 healthy male volunteers .
METHODS	Two FDC tablets of gemigliptin/metformin 25/500 mg or separate tablets of gemigliptin ( 50 mg 1 ) and metformin XR ( 500 mg 2 ) were orally administered in each period .
METHODS	Serial blood samples were collected up to 48 hours post-dose to determine dipeptidyl peptidase 4 ( DPP-4 ) activity using spectrophotometric assay and concentrations of gemigliptin and metformin using tandem mass spectrometry .
METHODS	Geometric mean ratios ( GMRs ) of FDC to separate tablet formulations and their 90 % confidence intervals ( CIs ) were calculated to compare the PD and PK parameters between the two formulations .
METHODS	Tolerability was assessed throughout the study .
RESULTS	The plasma DPP-4 activity-time curves of the FDC and the separate tablets almost overlapped , leading to a GMR ( 90 % CI ) of the FDC to separate tablets for the plasma DPP-4 activity and its maximum inhibition of 1.00 ( 0.97-1 .04 ) and 0.92 ( 0.82-1 .05 ) , respectively .
RESULTS	Likewise , all of the GMRs ( 90 % CIs ) of FDC to separate tablets for the area under the plasma concentration-time curve and maximum plasma concentration of gemigliptin and metformin fell entirely within the conventional bioequivalence range of 0.80-1 .25 .
RESULTS	Both the FDC and separate tablets were well tolerated .
CONCLUSIONS	The PD , PK , and tolerability profiles of gemigliptin and metformin XR in FDC and separate tablets were found to be comparable .
CONCLUSIONS	The FDC tablet of gemigliptin and metformin sustained release can be a convenient therapeutic option in patients with type 2 diabetes mellitus requiring a combination approach .

###24698202
OBJECTIVE	To compare the mean hospital discharge times and perioperative outcomes for radiofrequency volumetric thermal ablation ( RFVTA ) of fibroids and laparoscopic myomectomy ( LM ) .
METHODS	The present postmarket , randomized , prospective , single-center , longitudinal , comparative study , conducted in Tbingen , Germany , evaluated the outcomes of RFVTA and the current standard of care ( LM ) for symptomatic uterine fibroids in women who desired uterine conservation .
METHODS	The surgeons were blinded to the treatment until all fibroids had been mapped by laparoscopic ultrasound .
RESULTS	The mean hospitalization times were 10.0 5.5 ( median 7.8 [ range 4.2-25 .5 ] ) hours for the RFVTA group and 29.9 14.2 ( median 22.6 [ range 16.1-68 .1 ] ) hours for the LM group ( P < 0.001 , Wilcoxon test ) .
RESULTS	Intraoperative blood loss was 16 9 ( median 20 [ range : 0-30 ] ) mL for the RFVTA procedures and 51 57 ( median 35 [ range 10-300 ] ) mL for the LM procedures .
RESULTS	The percentage of fibroids imaged by laparoscopic ultrasound that were treated/excised was 98.6 % for RFVTA and 80.3 % for LM .
RESULTS	Two complications were reported : vertigo ( n = 1 ; RFVTA ) and port site hematoma ( n = 1 ; LM ) .
CONCLUSIONS	Radiofrequency volumetric thermal ablation resulted in the treatment of more fibroids , a significantly shorter hospital stay , and less intraoperative blood loss than laparoscopic myomectomy .
CONCLUSIONS	ClinicalTrials.gov : NCT01750008 .

###24582842
OBJECTIVE	To quantify the coupled motion of the wrist during selected functional tasks and to determine the effects of constraining this coupled motion using a radial-ulnar deviation blocking splint on performance of these tasks .
METHODS	Ten healthy , right-handed men performed 15 trials during selected functional tasks with and without a splint , blocking radial and ulnar deviation .
METHODS	The following tasks were performed : dart throwing , hammering , basketball free-throw , overhand baseball and football throwing , clubbing , and pouring .
METHODS	Kinematic coupling parameters ( coupling , kinematic path length , flexion-extension range of motion , radial-ulnar deviation range of motion , flexion-extension offset , and radial-ulnar deviation offset ) and performance were determined for each functional task .
METHODS	A generalized estimation equation model was used to determine whether each kinematic coupling parameter was significantly different across tasks .
METHODS	A repeated-measures generalized estimation equation model was used to test for differences in performance and kinematic coupling parameters between the free and splinted conditions .
RESULTS	Wrist motion exhibited linear coupling between flexion-extension and radial-ulnar deviation , demonstrated by R ( 2 ) values from 0.70 to 0.99 .
RESULTS	Average wrist coupling and kinematic path lengths were significantly different among tasks .
RESULTS	Coupling means and kinematic path lengths were different between free and splinted conditions across all tasks other than pouring .
RESULTS	Performance was different between wrist conditions for dart throwing , hammering , basketball shooting , and pouring .
CONCLUSIONS	Wrist kinematic coupling parameters are task specific in healthy individuals .
CONCLUSIONS	Functional performance is decreased when wrist coupling is constrained by an external splint .
CONCLUSIONS	Surgical procedures that restrict wrist coupling may have a detrimental effect on functional performance as defined in the study .
CONCLUSIONS	Patients may benefit from surgical reconstructive procedures and wrist rehabilitation protocols designed to restore kinematic coupling .

###26320293
OBJECTIVE	This open randomized study compares the effects of 24-week-long treatment with rosuvastatin and with atorvastatin coadministered with ezetimibe on the parameters of carbohydrate metabolism and the plasma levels of adipokynes in patients with coronary artery disease and type 2 diabetes mellitus or impaired glucose tolerance ( IGT ) .
METHODS	A total of 31 patients with coronary artery disease and type 2 diabetes mellitus or IGT were recruited in the study .
METHODS	Patients were randomized into two groups : group 1 included patients who received rosuvastatin therapy in an average dose of 12.5 mg/day ( n = 16 ) ; group 2 included patients who received combination treatment with atorvastatin in an average dose of 13.3 mg/day and ezetimibe ( 10 mg ) ( n = 15 ) .
METHODS	Plasma levels of lipids , apoB , apoA1 , glucose , insulin , leptin , and adiponectin were evaluated ; HOMA-IR index ( an empty stomach insulin , mu/l x fasting glucose , mmol/l ) / 22.5 ) was calculated .
RESULTS	During the therapy , the LDL-C and apoB levels decreased by 51.7 % and 42.3 % in group 1 and by 51.8 % and 44.9 % in group 2 , respectively .
RESULTS	Reduction in the triglyceride levels was significantly more pronounced in group 2 than in group 1 : 43.2 % vs 17.4 % ( p < 0.02 ) , whereas we did not observed significant changes of HDL-C and apoA1 in either group .
RESULTS	The increases in basal glycemia , basal insulinemia , HbA1c levels ( from 6.47 % [ 6.10-7 .02 % ] to 6.98 % 16.23-8 .18 % ] ) , and HOMA-IR ( from 2.14 [ 1.68-3 .51 ] to 4.30 [ 2.31-5 .77 ] ) were found only in group 2 ( p < 0.05 for all ) .
RESULTS	These changes were observed in 75 % of patients of group 2 independently of the presence of diabetic state or IGT , but the changes were more pronounced in patients with disturbed carbohydrate metabolism .
RESULTS	Changes of leptin levels during the therapy were diverse : 73 % patients of group 1 demonstrated decrease in the leptin levels , whereas 67 % of patients in group 2 experienced 57 % - increase in the leptin concentrations .
RESULTS	Degree of increased basal glycemia was associated with increase in the leptin levels ( r = 0.37 , p = 0.04 ) in the entire group of patients ( n = 31 ) .
RESULTS	Furthermore , changes in leptin levels were negatively associated with decreased adiponectin levels ( r = -0.57 , p = 0.034 ) .
CONCLUSIONS	In case of equivalent degree of the decrease in LDL-C levels , 24-week combination therapy with atorvastatin and ezetimibe , unlike rosuvastatin treatment , induced increases in basal glycemia , insulinemia , HbA1c , and HOMA-IR index irrespective of the presence of carbohydrate metabolism disturbances before treatment .
CONCLUSIONS	Our data suggest that adiponectin and leptin are involved in the mechanisms of adverse metabolic effects of the combination of atorvastatin and ezetimibe .

###24255008
OBJECTIVE	Mild traumatic brain injury ( mTBI ) and postconcussion syndrome ( PCS ) are common among military combatants .
OBJECTIVE	Hyperbaric oxygen ( HBO2 ) is a proposed treatment for these conditions , but it has not been rigorously studied .
OBJECTIVE	The objective of this study was to determine the effects of HBO2 by 3 months post compression at 2 commonly employed dosing levels to treat PCS ; whether specific subgroups may have benefited ; and if no overall effect was found , whether benefit is masked by other conditions .
METHODS	This randomized , double-blind , sham-controlled study was conducted at the Naval Air Station in Pensacola , Florida on 61 male Marines with a history of mTBI and PCS .
METHODS	Intervention consisted of 40 once daily 60-minute hyperbaric chamber compressions at 2.0 atmospheres absolute ( ATA ) at 1 of 3 randomly preassigned oxygen fractions , resulting in respective blinded groups with an oxygen-breathing exposure equivalent to ( 1 ) surface air ( sham ) , ( 2 ) 100 % oxygen at 1.5 ATA , or ( 3 ) 100 % oxygen at 2.0 ATA .
METHODS	The main outcome measure was the Rivermead Post-Concussion Questionnaire-16 ( RPQ-16 ) collected before compressions and at 2 later points .
RESULTS	The interaction of time by intervention group was not significant for improvement on the RPQ-16 .
RESULTS	Nor was there evidence of efficacy on the RPQ-16 for any subgroup .
RESULTS	No significant time by intervention interaction was found for any functional , cognitive , or psychomotor secondary outcome measure at an unadjusted 0.05 significance level .
CONCLUSIONS	Using a randomized control trial design and analysis including a sham , results showed no evidence of efficacy by 3 months post-compression to treat the symptomatic , cognitive , or behavioral sequelae of PCS after combat-related mTBI .

###25702400
OBJECTIVE	To assess and compare the safety and efficacy of allapinine and quinidine bisulphate in the treatment of patients with persistent atrial fibrillation after cardioversion .
OBJECTIVE	Design -- Prospective , randomised , open study .
OBJECTIVE	Patients -- 73 consecutive patients ( men only , mean age 44 11 years ) with persisnent atrial fibrillation and flutter .
OBJECTIVE	Interventions -- 37 patients were randomised to allapinine ( ALP ) ( 1.5 mg/kg/d ) , 36 to quinidine bisulphate ( QUIN ) ( 15 mg/kg/d ) with subsequent successful pharmacological or electrical cardioversion .
OBJECTIVE	Main outcome measures -- Recurrence of atrial fibrillation or side effects .
RESULTS	In the ALP group 15 of the 37 patients developed atrial fibrillation up to 12 month of follow-up , while in the QUIN group 20 patients developed atrial fibrillation and 5 experienced significant side effects .
RESULTS	Relative risk ( RR ) ( ALP vs QUIN ) 0.58 ( 95 % CI 0.37-0 .91 , p < 0.02 ) .
RESULTS	The number needed to treat ( NNT ) was ( -3.48 ) ( 14.2-1 .97 harm ) .
RESULTS	When 5 patients with significant side effects were excluded from the analysis RR was 0.62 ( 95 % CI 0.39-1 .0 , p = 0.052 ) and NNT -- ( -4.1 ) ( 122.7-2 .1 harm ) but power of the study was too low -- 67 % .
CONCLUSIONS	Allapinine is as effective as quinidine bisulphate in the long term treatment of patients with persistent atrial fibrillation after successful cardioversion but causes significantly less side effects .

###24401205
BACKGROUND	Bovine herpesvirus type 1 ( BoHV-1 ) is the causative agent of respiratory and genital tract infections ; causing a high economic loss in all continents .
BACKGROUND	Use of marker vaccines in IBR eradication programs is widely accepted since it allows for protection of the animals against the disease while adding the possibility of differentiating vaccinated from infected animals.The aim of the present study was the development and evaluation of safety and efficacy of a glycoprotein E-deleted ( gE - ) BoHV-1 marker vaccine strain ( BoHV-1gEgal ) generated by homologous recombination , replacing the viral gE gene with the - galactosidase ( gal ) gene .
RESULTS	In vitro growth kinetics of the BoHV-1gEgal virus was similar to BoHV-1 LA. .
RESULTS	The immune response triggered by the new recombinant strain in cattle was characterized both as live attenuated vaccine ( LAV ) and as an inactivated vaccine .
RESULTS	BoHV-1gEgal was highly immunogenic in both formulations , inducing specific humoral and cellular immune responses .
RESULTS	Antibody titers found in animals vaccinated with the inactivated vaccine based on BoHV-1gEgal was similar to the titers found for the control vaccine ( BoHV-1 LA ) .
RESULTS	In the same way , titers of inactivated vaccine groups were significantly higher than any of the LAV immunized groups , independently of the inoculation route ( p < 0.001 ) .
RESULTS	Levels of IFN - were significantly higher ( p < 0.001 ) in those animals that received the LAV compared to those that received the inactivated vaccine .
RESULTS	BoHV-1gEgal exhibited an evident attenuation when administered as a LAV ; no virus was detected in nasal secretions of vaccinated or sentinel animals during the post-vaccination period .
RESULTS	BoHV-1gEgal , when used in either formulation , elicited an efficient immune response that protected animals against challenge with virulent wild-type BoHV-1 .
RESULTS	Also , the deletion of the gE gene served as an immunological marker to differentiate vaccinated animals from infected animals .
RESULTS	All animals vaccinated with the BoHV-1gE gal strain were protected against disease after challenge and shed significantly less virus than control calves , regardless of the route and formulation they were inoculated .
CONCLUSIONS	Based on its attenuation , immunogenicity and protective effect after challenge , BoHV-1gEgal virus is an efficient and safe vaccine candidate when used either as inactivated or as live attenuated forms .

###25790672
OBJECTIVE	To evaluate the clinical efficacy and safety of Qiangji Recipe ( QR ) in ad - junctive treatment of axial undifferentiated spondyloarthritis ( axuSpA ) through a four-week open study .
METHODS	Fifty-four axuSpA patients of Shen-deficiency Du-channel cold syndrome ( SDDCS ) in line with inclusive criteria were recruited and assigned to the treatment group and the control group according to random digit table , 27 in each group .
METHODS	Patients in the control group took Celecoxib Capsule ( 0.2 g each time , twice per day ) .
METHODS	Patients in the treatment group additionally took QR ( consisting of Herba Epimedii 15 g , antler glue 15 g , Cibotium Barometz 15 g , eucommia bark 20 g , dipsacus asper 10 g , two toothed achyranthes root 15 g , drynaria 15 g , Taxillus Chinensis 20 g , ground beetle 10 g , scorpion 5 g , wild celery 10 g , notopterygium incisium 10 g , cow-fat seed 10 g , white mustard seed 6 g , and licorice root 6 g , one dose per day , twice daily ) .
METHODS	The therapeutic course for all was 4 weeks .
METHODS	The Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) , the Bath Ankylosing Spondylitis Functional Index ( BASFI ) , the Bath AS Metrology Index ( BASMI ) , total body pain and spinal pain , patient and physician global assessment on a four-point scale , the Ankylosing Spondylitis Quality of Life ( ASQoL ) , erythrocyte sedimentation rate ( ESR ) and C-reactive protein ( CRP ) were measured before and after 4 weeks of treatment .
METHODS	The primary end point in this study was the proportion of patients with a 20 % improvement response accord - ing to the ASAS International Working Group Criteria ( ASAS 20 responders ) at week 4 .
RESULTS	Totally 50 patients completed this trial , 26 in the treatment group and 24 in the control group .
RESULTS	Improvement of BASDAI , BASFI , BASMI , ASQoL , ESR , and CRP was shown in both groups after treatment .
RESULTS	Better effect was shown in the treatment group in all indices except ESR and BASMI after treatment ( P < 0.05 , P < 0.01 ) .
RESULTS	Twenty cases ( accounting for 76.92 % ) in the treatment group achieved ASAS 20 response at week 4 , while 12 cases ( accounting for 50.00 % ) in the control group achieved ASAS 20 response at week 4 ( P < 0.05 ) .
RESULTS	No obvious adverse reaction occurred in the two groups .
CONCLUSIONS	QR combined Celecoxib Capsule showed better effect in treating axuSpA patients than using Celecoxib Capsule alone .

###25884803
BACKGROUND	The ` Supporting Teachers And childRen in Schools ' ( STARS ) study is a cluster randomised controlled trial evaluating the Incredible Years Teacher Classroom Management ( TCM ) programme as a public health intervention .
BACKGROUND	TCM is a 6 day training course delivered to groups of 8-12 teachers .
BACKGROUND	The STARS trial will investigate whether TCM can improve children 's behaviour , attainment and wellbeing , reduce teachers ' stress and improve their self-efficacy .
BACKGROUND	This protocol describes the methodology of the process evaluation embedded within the main trial , which aims to examine the uptake and implementation of TCM strategies within the classroom plus the wider school environment and improve the understanding of outcomes .
METHODS	The STARS trial will work with eighty teachers of children aged 4-9 years from eighty schools .
METHODS	Teachers will be randomised to attend the TCM course ( intervention arm ) or to `` teach as normal '' ( control arm ) and attend the course a year later .
METHODS	The process evaluation will use quantitative and qualitative approaches to assess fidelity to model , as well as explore headteachers ' and teachers ' experiences of TCM and investigate school factors that influence the translation of skills learnt to practice .
METHODS	Four of the eight groups of teachers ( n = 40 ) will be invited to participate in focus groups within one month of completing the TCM course , and again a year later , while 45 of the 80 headteachers will be invited to take part in telephone interviews .
METHODS	Standardised checklists will be completed by group leaders and each training session will be videotaped to assess fidelity to model .
METHODS	Teachers will also complete standardised session evaluations .
CONCLUSIONS	This study will provide important information about whether the Teacher Classroom Management course influences child and teacher mental health and well-being in both the short and long term .
CONCLUSIONS	The process evaluation will provide valuable insights into factors that may facilitate or impede any impact .
BACKGROUND	The trial has been registered with ISCTRN ( Controlled Trials Ltd ) and assigned an ISRCTN number ISRCTN84130388 .
BACKGROUND	Date assigned : 15 May 2012 .

###24284154
BACKGROUND	The Quality Initiative in Rectal Cancer ( QIRC ) trial targeted surgeon intraoperative technique and not radiation therapy ( RT ) use .
BACKGROUND	We performed a post hoc analysis of RT use among patients in the QIRC trial , not by arm of trial but rather for the entire group .
BACKGROUND	We wished to identify associations between local recurrence risk and use of preoperative , postoperative or no RT. .
METHODS	We compared demographic , tumour and process of care measures among patients receiving preoperative , postoperative or no RT. .
METHODS	A multivariable Cox regression model assessed local recurrence risk .
RESULTS	The QIRC trial enrolled 1015 patients at 16 hospitals between 2002 and 2004 .
RESULTS	Radiation therapy use did not differ between trial arms , and median follow-up was 3.6 years .
RESULTS	For the preoperative , postoperative and no RT groups , respectively , the percentage of patients was 12.8 % , 19.3 % and 67.9 % ; the percentage of stage II/III tumours was 57.0 % , 88.7 % and 48.1 % ; and the local recurrence rate was 5.3 % , 10.2 % and 5.5 % ( p = 0.05 ) .
RESULTS	After controlling for patient and tumour characteristics , including tumour stage , the hazard ratio ( HR ) for local recurrence was increased in the postoperative RT versus the no RT group ( HR 1.64 , 95 % confidence interval 1.04-2 .58 , p = 0.027 ) .
CONCLUSIONS	Use of preoperative RT was low ; most patients with stage II/III disease did not receive RT and , as expected , the postoperative RT group had the highest risk of local recurrence .
CONCLUSIONS	Our results suggest opportunities to improve rectal cancer RT use in Ontario .

###24389597
BACKGROUND	Levels of platelet reactivity in patients on dual antiplatelet therapy ( DAPT ) can be influenced by concomitant treatment with statins .
BACKGROUND	We verified if the pharmacodynamic effects of CYP3A4-metabolized statins ( atorvastatin ) and non-CYP3A4-metabolized statins ( pitavastatin ) differ in patients with coronary artery disease ( CAD ) treated with DAPT .
RESULTS	A total of 155 CAD patients receiving DAPT ( clopidogrel 75mg plus aspirin 100mg ) entered the PORTO trial .
RESULTS	Patients were randomly assigned to atorvastatin ( 20mg day ) or pitavastatin ( 4mg day ) for 30 days , and then switched to the other drug for 30 days .
RESULTS	Platelet reactivity was expressed as VerifyNow P2Y12 platelet response units ( PRU ) before and after each 30-day treatment period .
RESULTS	High platelet reactivity was defined as PRU > 208 .
RESULTS	As compared with pretreatment ( 19249 ) , PRU was significantly higher after 30-day atorvastatin ( 21056 ; P = 0.003 ) , but was unchanged after 30-day pitavastatin ( 19947 PRU , NS ) .
RESULTS	In the 48 patients with PRU > 208 at baseline ( 23244 ) , PRU increased significantly after 30-day atorvastatin ( 25841 , P = 0.004 ) , but not after 30-day pitavastatin ( 23743 , NS ) .
RESULTS	In the 107 patients with PRU < 208 at baseline ( 17452 ) , PRU did not change significantly with respect to baseline either after 30-day atorvastatin ( 18861 , NS ) or after 30-day pitavastatin ( 18159 , NS ) .
CONCLUSIONS	Pitavastatin , a non-CYP3A4-metabolized statin , does not affect clopidogrel 's response as compared with atorvastatin in patients who are borderline or poor responders to DAPT .

###25818496
BACKGROUND	With accumulating knowledge on osteoarthritis development , the next step is to focus on possibilities for primary prevention .
METHODS	In a 2 2 factorial design , the effects of a diet-and-exercise program and of oral glucosamine sulfate ( double blind and placebo-controlled ) on the incidence of knee osteoarthritis were evaluated in a high-risk group of 407 middle-aged women with a body mass index 27 kg/m ( 2 ) without clinical signs of knee osteoarthritis at baseline ( ISRCTN 42823086 ) .
METHODS	Primary outcome was the incidence of knee osteoarthritis , defined as Kellgren & Lawrence grade 2 , joint space narrowing of 1.0 mm , or clinical knee osteoarthritis ( clinical and radiographic American College of Rheumatology criteria ) after 2.5 years .
RESULTS	After 2.5 years , only 10 % of all subjects were lost to follow-up , and 17 % of all knees showed incident knee osteoarthritis .
RESULTS	Accounting for the significant interaction between the interventions , no significant main effect of either intervention was found .
RESULTS	Independently , both interventions alone showed indications of reduced knee osteoarthritis incidence ( odds ratio [ OR ] 0.69 ; 95 % CI , 0.39-1 .21 for the diet-and-exercise program and OR 0.60 ; 95 % CI , 0.31-1 .12 for the glucosamine intervention ) .
RESULTS	These effects were neutralized in subjects receiving both interventions ( OR 0.97 ; 95 % CI , 0.55-1 .71 ) .
CONCLUSIONS	No significant main effects of the diet-and-exercise program and of glucosamine sulfate were found on incident knee osteoarthritis .
CONCLUSIONS	Nevertheless , this trial provides valuable insights for future trial design for preventive osteoarthritis studies .

###25686304
OBJECTIVE	Sleep disturbances are most prevalent among older adults and often go untreated .
OBJECTIVE	Treatment options for sleep disturbances remain limited , and there is a need for community-accessible programs that can improve sleep .
OBJECTIVE	To determine the efficacy of a mind-body medicine intervention , called mindfulness meditation , to promote sleep quality in older adults with moderate sleep disturbances .
METHODS	Randomized clinical trial with 2 parallel groups conducted from January 1 to December 31 , 2012 , at a medical research center among an older adult sample ( mean [ SD ] age , 66.3 [ 7.4 ] years ) with moderate sleep disturbances ( Pittsburgh Sleep Quality Index [ PSQI ] > 5 ) .
METHODS	A standardized mindful awareness practices ( MAPs ) intervention ( n = 24 ) or a sleep hygiene education ( SHE ) intervention ( n = 25 ) was randomized to participants , who received a 6-week intervention ( 2 hours per week ) with assigned homework .
METHODS	The study was powered to detect between-group differences in moderate sleep disturbance measured via the PSQI at postintervention .
METHODS	Secondary outcomes pertained to sleep-related daytime impairment and included validated measures of insomnia symptoms , depression , anxiety , stress , and fatigue , as well as inflammatory signaling via nuclear factor ( NF ) - B.
RESULTS	Using an intent-to-treat analysis , participants in the MAPs group showed significant improvement relative to those in the SHE group on the PSQI .
RESULTS	With the MAPs intervention , the mean ( SD ) PSQIs were 10.2 ( 1.7 ) at baseline and 7.4 ( 1.9 ) at postintervention .
RESULTS	With the SHE intervention , the mean ( SD ) PSQIs were 10.2 ( 1.8 ) at baseline and 9.1 ( 2.0 ) at postintervention .
RESULTS	The between-group mean difference was 1.8 ( 95 % CI , 0.6-2 .9 ) , with an effect size of 0.89 .
RESULTS	The MAPs group showed significant improvement relative to the SHE group on secondary health outcomes of insomnia symptoms , depression symptoms , fatigue interference , and fatigue severity ( P < .05 for all ) .
RESULTS	Between-group differences were not observed for anxiety , stress , or NF-B , although NF-B concentrations significantly declined over time in both groups ( P < .05 ) .
CONCLUSIONS	The use of a community-accessible MAPs intervention resulted in improvements in sleep quality at immediate postintervention , which was superior to a highly structured SHE intervention .
CONCLUSIONS	Formalized mindfulness-based interventions have clinical importance by possibly serving to remediate sleep problems among older adults in the short term , and this effect appears to carry over into reducing sleep-related daytime impairment that has implications for quality of life .
BACKGROUND	clinicaltrials.gov Identifier : NCT01534338 .

###24460796
BACKGROUND	While emergency room ( ER ) studies have documented a strong association of alcohol with injury , these studies are not necessarily representative of the general population .
BACKGROUND	To evaluate comparative risk of injury from drinking for those treated in the ER with non-ER-treated injuries ( those treated elsewhere or those not treated ) , data on alcohol and injury are analyzed in the U.S. general population by type of injury treatment .
METHODS	Relative risk ( RR ) of injury from drinking within 6 hours prior to the event was analyzed using case-crossover analysis based on respondents ' usual frequency of drinking in 4 ( 1995 to 2010 ) National Alcohol Surveys ( n = 4,819 ) .
RESULTS	RR was 1.01 for the total injured and significantly elevated for ER-treated injured ( 1.46 ) , but not for those treated elsewhere ( 0.75 ) and those not treated ( 1.02 ) .
RESULTS	RR was significantly elevated for those aged 18 to 30 years ( 1.45 ; 1.14 , 1.85 ) , Blacks ( 1.54 ; 1.11 , 2.14 ) and Hispanics ( 1.98 ; 1.51 , 2.59 ) , those positive on the Rapid Alcohol Problems Screen ( RAPS4 ) as a measure of alcohol dependence ( 2.41 ; 1.86 , 3.11 ) , and for motor vehicle injuries ( 2.61 ; 1.49 , 4.58 ) or cutting/piercing injuries ( 2.04 , 1.10 , 3.81 ) .
RESULTS	For those reporting ER-treated injuries , significant effect modification was found for those aged 18 to 30 years ( RR = 2.29 ) , Blacks ( RR = 2.59 ) and Hispanics ( RR = 2.68 ) , high risk-taking ( RR = 1.71 ) , positive RAPS4 ( RR = 3.69 ) , and for motor vehicle ( RR = 3.79 ) and cutting/piercing injuries ( RR = 2.60 ) .
CONCLUSIONS	Data suggest alcohol plays a larger role in injuries for which ER treatment is sought than for other injuries , and estimates for injury from drinking derived from ER studies may be elevated .
CONCLUSIONS	Future general population studies should take into account intensity of exposure to alcohol prior to injury , potential recall bias ( by eliciting data on the proximity of injury to time of the respondent interview ) and severity of injury , for improving estimates of the attributable burden of alcohol to injury in society .

###24996893
OBJECTIVE	To compare the astigmatism-reducing effect of an aspheric toric intraocular lens ( IOL ) and an aspheric nontoric IOL with an opposite clear corneal incision ( OCCI ) in cataract surgery .
METHODS	Vienna Institute for Research in Ocular Surgery , Hanusch Hospital , Vienna , Austria .
METHODS	Prospective randomized clinical study .
METHODS	Patients with low to moderate corneal astigmatism scheduled for cataract surgery received an aspheric toric IOL ( Lentis L-312T ) or an aspheric nontoric IOL ( Lentis L-312 ) combined with an OCCI .
METHODS	Keratometry and corneal tomography were performed 1 hour , 1 week , 3 months and 9 months postoperatively .
METHODS	Postoperative residual astigmatism was measured using an autorefractor .
METHODS	Rotational toric IOL stability was analyzed using retroillumination photography .
RESULTS	Fifty-five patients were included .
RESULTS	Three months postoperatively , the mean reduction in corneal astigmatism was 0.67 diopter ( D ) 0.58 ( SD ) in the toric group and 0.18 0.52 D in the nontoric-OCCI group .
RESULTS	The mean uncorrected distance visual acuity was 0.29 0.30 logMAR and 0.09 0.18 logMAR , respectively ( P = .02 ) .
RESULTS	The mean refractive astigmatism was 1.02 0.54 D and 0.68 0.52 D , respectively ( P = .05 ) .
RESULTS	One hour , 3 months , and 9 months postoperatively , the mean absolute IOL misalignment of toric IOLs was 4.99 4.66 degrees , 13.59 11.29 degrees , and 19.90 14.48 degrees , respectively .
CONCLUSIONS	The toric IOL tended to rotate significantly postoperatively .
CONCLUSIONS	Visual acuity was good in both groups .
CONCLUSIONS	Residual refractive cylinder was significantly lower in the toric IOL group .
BACKGROUND	No author has a financial or proprietary interest in any material or method mentioned .

###25112970
METHODS	Randomized , double-blind , crossover , sham-controlled trial .
OBJECTIVE	Repetitive transcranial magnetic stimulation ( rTMS ) over the primary motor cortex ( M1 ) leads to a significant reduction of spasticity in subjects with spinal cord injury ( SCI ) , but the physiological basis of this effect is still not well understood .
OBJECTIVE	The purpose of this study was to evaluate the disynaptic reciprocal Ia inhibition of soleus motoneurons in SCI patients .
METHODS	Department of Neurology , Merano , Italy and TMS Laboratory , Paracelsus Medical University , Salzburg , Austria .
METHODS	Nine subjects with incomplete cervical or thoracic SCI received 5 days of daily sessions of real or sham rTMS applied over the contralateral M1 .
METHODS	We compared the reciprocal inhibition , the Modified Ashworth Scale and the Spinal Cord Injury Assessment Tool for Spasticity at baseline , after the last session and 1 week later in the real rTMS and sham stimulation groups .
RESULTS	We found that real rTMS significantly reduced lower limb spasticity and restored the impaired excitability in the disynaptic reciprocal inhibitory pathway .
CONCLUSIONS	In a small proof-of-concept study , rTMS strengthened descending projections between the motor cortex and inhibitory spinal interneuronal circuits .
CONCLUSIONS	This reversed a defect in reciprocal inhibition after SCI , and reduced leg spasticity .

###26054178
OBJECTIVE	A controlled , clinical , double-blind study was conducted to assess the efficacy of sugar-free tablets containing zinc lactate and magnolia bark extract ( MBE ) on oral volatile sulfur-containing compounds ( VSC ) versus placebo tablets for two hours .
METHODS	In order to join the study , subjects had to have at least 24 teeth , no report of oral and systemic diseases , and no removable dentures .
METHODS	All 128 eligible participants had to avoid any professional oral hygiene , refrain from taking medicines for two weeks , be not menstruating , and not brush their teeth and tongue , smoke , drink alcohol , coffee or tea , eat onion , garlic , or licorice for a six-hour period before the visit and during the test .
METHODS	Moreover , to join the protocol , they had to show a VSC score of 75 ppb at the baseline measurement .
METHODS	Each qualified subject was placed in the test or the control group using a table of random numbers .
METHODS	The test tablet ( 0.7 g ) contained 0.17 mg of zinc , in the form of zinc lactate , and 0.84 mg magnolia bark extract ; the control tablet was identical , but without these active agents .
METHODS	The OralChroma2 device was utilized to evaluate total oral VSC .
METHODS	Their levels were recorded at baseline , after eight minutes of sucking two tablets in succession , after one hour , and after two hours .
METHODS	Data were analyzed with SPSS software and the level of significance was set at = 0.05 .
RESULTS	One hundred subjects completed the trial ( 50 in the control group and 50 in the test group ) ; 52 men and 48 women , mean age 38 .
RESULTS	None reported problems linked to zinc lactate or magnolia bark extract .
RESULTS	The mean percentage reduction from baseline at the end of eight minutes of tablet sucking was 39 % in the control group ( p < 0.001 ) and 62 % in the test group ( p < 0.001 ) ; one hour later it was 6 % in the control group and 30 % in the test group ( p < 0.001 ) , and two hours later it was 2 % in the control group and 18 % in the test group ( p < 0.001 ) .
RESULTS	The comparisons between the two groups after baseline adjustment showed a statistically significant difference in reductions of VSC between the test and the control tablets at the end of the sucking period ( p < 0.01 ) , after one hour ( p < 0.001 ) , and after two hours ( p < 0.05 ) .
CONCLUSIONS	Tablets containing zinc lactate and magnolia bark extract can statistically significantly reduce the oral VSC levels for over two hours and were statistically significantly more effective than a control tablet .

###24424780
OBJECTIVE	Cognitive impairment is integral to many neurological illnesses .
OBJECTIVE	Specific enhancement of glutamatergic transmission may improve memory and learning .
OBJECTIVE	Org 25935 increases the synaptic availability of glycine , an obligate co-agonist with glutamate at N-methyl-D-aspartate receptors .
OBJECTIVE	We hypothesised that Org 25935 would acutely improve the learning and memory of healthy volunteers .
METHODS	A randomised , double-blind , parallel-group , single-dose study of Org 25935 and placebo was carried out .
METHODS	Thirty-two healthy male volunteers took either 12-mg Org 25935 or matching placebo and were later assessed with the manikin task , digit span and verbal memory tests .
METHODS	Systematic assessments of cardiovascular and adverse events were also taken .
RESULTS	There was no effect of Org 25935 on reaction time , number of correct responses or learning ( greater or slower improvement over successive tasks ) compared with placebo .
RESULTS	Org 25935 caused significantly more dizziness and drowsiness compared with placebo ; these side effects were mainly mild .
CONCLUSIONS	A single dose of Org 25935 does not improve learning or memory in healthy male individuals .
CONCLUSIONS	However , the drug was well tolerated , and it remains to be seen whether it would have a positive effect on cognition in patient groups with pre-existing cognitive deficits .

###25639187
BACKGROUND	The American College of Emergency Physicians and the American Society of Clinical Oncology recommend early palliative care consultation for patients with advanced , life-limiting illnesses , such as metastatic cancer .
OBJECTIVE	The objectives were to assess the process of early referral from the emergency department ( ED ) to palliative care for patients with advanced , incurable cancer as part of a randomized controlled trial and to compare the proportion and timing of consultation to a care as usual group .
METHODS	A single-blind randomized controlled trial ( ClinicalTrials.gov ID NCT01358110 ) compared early , ED-based referrals to palliative care for patients admitted with advanced , incurable cancer to physician-driven consultation ( i.e. , care as usual ) .
METHODS	Participants had to speak English or Spanish and have no history of palliative care consultation .
METHODS	They were randomized via balanced block randomization to the intervention or control group .
METHODS	Each intervention subject was referred by a research staff member to the palliative care team for consultation .
METHODS	The usual care group received palliative care only if requested by the admitting physician .
METHODS	Analysis was based on intention to treat .
METHODS	A chart review was performed to assess proportion and timing of palliative care consults during the index admission , defined as : ( 1 ) completed palliative care consult documented in the chart and ( 2 ) days from admission to palliative care consult .
RESULTS	A total of 134 participants were enrolled and randomized .
RESULTS	For patients in the intervention group , 88 % ( 60 of 68 ) had documented palliative care consultations during their index admissions ( 95 % confidence interval [ CI ] = 80.5 to 95.5 ) , compared to 18 % ( 12 of 66 ) in the control group ( 95 % CI = 8.8 to 27.5 ; p < 0.01 ) .
RESULTS	The 60 intervention patients received palliative care consultations on average 1.48 days from admission ( 95 % CI = 1.19 to 1.76 ) , compared to 2.9 days from admission in the 12 control patients ( 95 % CI = 1.03 to 4.79 ; p = 0.15 ) .
CONCLUSIONS	This study documented a low baseline rate of palliative care involvement as part of usual care in patients with advanced cancer being admitted from the ED .
CONCLUSIONS	Early referral to palliative care in the context of a research study significantly increased the likelihood that patients received a consult , thus meriting further investigation of how to generalize this approach .

###25727139
OBJECTIVE	Brief postsurgical electrical stimulation ( ES ) has been shown to enhance peripheral nerve regeneration in animal models following axotomy and crush injury .
OBJECTIVE	However , whether this treatment is beneficial in humans with sensory nerve injury has not been tested .
OBJECTIVE	The goal of this study was to test the hypothesis that ES would enhance sensory nerve regeneration following digital nerve transection compared to surgery alone .
METHODS	Patients with complete digital nerve transection underwent epineurial nerve repair .
METHODS	After coaptation of the severed nerve ends , fine wire electrodes were implanted before skin closure .
METHODS	Postoperatively , patients were randomized to receiving either 1 hour of 20Hz continuous ES or sham stimulation in a double-blinded manner .
METHODS	Patients were followed monthly for 6 months by a blinded evaluator to monitor physiological recovery of spatial discrimination , pressure threshold , and quantitative small fiber sensory testing .
METHODS	Functional disability was measured using the Disability of Arm , Shoulder , and Hand questionnaire .
RESULTS	A total of 36 patients were recruited , with 18 in each group .
RESULTS	Those in the ES group showed consistently greater improvements in all sensory modalities by 5 to 6 months postoperatively compared to the controls .
RESULTS	Although there was a trend of greater functional improvements in the ES group , it was not statistically significant ( p > 0.01 ) .
CONCLUSIONS	Postsurgical ES enhanced sensory reinnervation in patients who sustained complete digital nerve transection .
CONCLUSIONS	The conferred benefits apply to a wide range of sensory functions .

###24256460
BACKGROUND	A ready-to-use betamethasone valerate 0.1 % ( BMV ) dressing was found to be superior to placebo dressing and a reference 0.1 % BMV cream in the treatment of patients with chronic plaque psoriasis ( CPP ) .
METHODS	This multicentre , prospective , randomized , investigator-blinded , controlled , non-inferiority trial compared the efficacy and safety of the BMV dressing to the calcipotriol-betamethasone dipropionate ( CBD ) ointment during a 4-week treatment of patients with mild to moderate CPP .
METHODS	The primary efficacy endpoint was the 4-item psoriasis total severity score ( TSS-4 ) at week 4 , and the associated non-inferiority margin was 1 point .
METHODS	Secondary outcome measures included the psoriasis global assessment ( PGA ) score and patients ' quality of life ( QoL ) .
METHODS	Safety was assessed through adverse events ( AE ) reporting in each treatment group .
RESULTS	Of 325 screened patients , 324 were randomized to BMV ( N = 165 ) or CBD ( N = 159 ) , and were considered evaluable for the safety and intention-to-treat ( ITT ) efficacy analyses .
RESULTS	Per protocol ( PP ) populations included 133 and 131 patients in the BMV and CBD groups respectively .
RESULTS	The mean adjusted TSS-4 significantly decreased through the study from baseline in both groups .
RESULTS	The PP ( primary ) analysis of week 4 data revealed a -0.288 ( 95 % CI : -0.610 to 0.034 ) not significant between-group difference in adjusted means , demonstrating non-inferiority of BMV to CBD .
RESULTS	Non-inferiority was also demonstrated in the ITT analysis .
RESULTS	The PGA and other secondary outcomes were significantly improved from baseline in both groups at week 4 .
RESULTS	The QoL score was slightly better in the CBD group at week 4 , but no difference was observed at follow-up .
RESULTS	No safety or tolerability concerns were observed in either group .
CONCLUSIONS	BMV dressing is non-inferior to CBD ointment in patients with mild to moderate CPP .
CONCLUSIONS	Both treatments significantly improve patients ' psoriasis and QoL .

###25669080
BACKGROUND	Camera eye in the McGrath video-laryngoscope blade is located closer to the larynx , which may allow reduction of the head-neck movement during laryngoscopy compared with a conventional laryngoscope .
BACKGROUND	We compared the degree of head extension during laryngoscopy with McGrath laryngoscope and that with Macintosh laryngoscope .
METHODS	Fifty patients without cervical spine abnormality were randomized into two groups : laryngoscopies with Macintosh laryngoscope and that with McGrath laryngoscope .
METHODS	Each patient wearing goggles mounted with a goniometer lay supine with the head in the neutral position .
METHODS	After general anesthesia and muscle relaxation were obtained an experienced anesthesiologist obtained the best glottic view using either laryngoscope , and change in the angle of goggles ( head extension angle ) during laryngoscopy was measured .
METHODS	In addition , we compared the head extension angle with extension angle of the cervical spine between the occiput and the fourth cervical vertebra ( C0-4 ) measured radiologically in 7 healthy volunteers .
RESULTS	Head extension angles with Macintosh and McGrath laryngoscopes were 18.2 4.3 degrees and 9.6 2.7 degrees , respectively ( P < 0.0001 ) .
RESULTS	There was a strong relationship between head extension angle and C0-4 extension angle measured radiologically in the volunteers ( r = 0.92 , P < 0.0001 ) .
CONCLUSIONS	The McGrath laryngoscope may be a reasonable technique of choice for intubation when minimal cervical spine movement is indispensable because of reduction of head extension during laryngoscopy compared with the conventional laryngoscopy .

###25375652
OBJECTIVE	To assess short-term efficacy and safety of desvenlafaxine 50 and 100 mg/d versus placebo for treating major depressive disorder ( MDD ) .
OBJECTIVE	Assessment of sexual function was a secondary objective .
METHODS	Outpatients ( 18 years ) who met criteria for MDD from the Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , Text Revision and had screening and baseline 17-item Hamilton Depression Rating Scale ( HDRS17 ) total scores 20 were randomly assigned to placebo or desvenlafaxine 50 or 100 mg/d in an 8-week study conducted from October 2011 to August 2012 .
METHODS	The primary efficacy end point was change from baseline in HDRS17 total score at week 8 , analyzed using a mixed-effects model for repeated measures .
METHODS	Sexual function was assessed using the Arizona Sexual Experiences Scale ( ASEX ) .
RESULTS	The safety population included 909 patients ( intent-to-treat population , n = 886 ) .
RESULTS	Significantly greater improvement in adjusted mean HDRS17 total score from baseline to week 8 was observed for desvenlafaxine 50 mg ( -11.28 ; P = .006 ) and desvenlafaxine 100 mg ( -11.67 ; P < .001 ) compared with placebo ( -9.71 ) , with adjustment for multiplicity .
RESULTS	In the ASEX total score analysis ( n = 422 ) , the treatment by gender interaction was not significant ; thus , genders were combined for subsequent analyses .
RESULTS	Comparisons for desvenlafaxine versus placebo for change from baseline in ASEX total and all item scores found P > .05 , with no adjustment for multiplicity .
RESULTS	Rates of sexual dysfunction based on ASEX were comparable among treatment groups .
CONCLUSIONS	These results support previous findings demonstrating antidepressant efficacy , safety , and tolerability of desvenlafaxine 50 and 100 mg/d versus placebo .
CONCLUSIONS	Sexual function was comparable between desvenlafaxine and placebo .
BACKGROUND	ClinicalTrials.gov identifier : NCT01432457 .

###24239044
BACKGROUND	Rapid and early virological responses to peginterferon-alpha and ribavirin are predictive of sustained virological response ( SVR ) in hepatitis C virus ( HCV ) infection .
BACKGROUND	We aimed at finding a simple rule to determine the shortest duration of dual therapy for all HCV genotypes , obtained by multiplying time to Initial Viral Response , IVR ( first undetectable HCV-RNA ) by 4 ( Tailored Therapy-4 , or TT4 ) .
METHODS	267 nave HCV-infected patients with compensated liver disease were randomized ( 2:1 ) to the TT4 ( n = 180 ) or current standard-of-care ( SoC , n = 87 ) and received peginterferon-alpha plus ribavirin .
METHODS	Patients with HCV-RNA decrease 2log10 at week 12 or detectable HCV-RNA at week 24 discontinued treatment .
RESULTS	Both groups had comparable baseline characteristics , SVR rates were similar in the whole population ( 60.6 % vs. 60.9 % ) and within each genotype subgroup ( G1 : 46.6 % vs. 55.6 % ; G2 : 90.2 % vs. 94.4 % ; G3 : 74.1 % vs. 58.3 % ; G4 : 45.8 % vs. 33.3 % ) .
RESULTS	Relapse rate was higher in G1-TT4 than G1-SoC .
RESULTS	Treatment duration in SVR patients was shorter in TT4 compared to SoC , both overall [ 2515 vs. 3612.1 weeks ] , and for subgroups : G1 [ 35.316.7 vs. 47.32.6 weeks ] , G2 [ 18.37.5 vs. 242.8 weeks ] , G3 [ 15.28.7 vs. 22.83 weeks ] and G4 [ 26.913 vs. 48 weeks ] .
CONCLUSIONS	In HCV-naive patients , TT4-rule treatment yields similar SVR rates compared to SoC but with shorter treatment duration and remarkable cost reduction .

###25003921
OBJECTIVE	To determine the efficacy of stress urinary incontinence treatments adding pelvic floor muscle training to vaginal electrical stimulation .
METHODS	Forty-eight women with stress urinary incontinence were randomized into 2 groups : 24 underwent isolated vaginal electrical stimulation , and 24 vaginal electrical stimulation plus pelvic floor muscle training .
METHODS	History , physical examination , voiding diary , perineum strength test , and urodynamic study were assessed .
METHODS	Comparisons were made for adherence to treatment , muscle strength improvement , urinary symptoms , and degree of satisfaction immediately , 12 and 96 months after treatment .
RESULTS	Patients ' degree of satisfaction on vaginal electrical stimulation , and on vaginal electrical stimulation plus pelvic floor muscle training immediately , 12 and 96 months post treatment , were , respectively : 88.2 % versus 88.9 % 64.7 % versus 61.1 % and 42.9 % versus 28.6 % ( p > 0.05 ) .
CONCLUSIONS	Vaginal electrical stimulation associated to pelvic floor muscle training did not show better results than vaginal electrical stimulation alone .

###25034509
BACKGROUND	To evaluate and compare the efficacy of vaginal misoprostol and a rectal nonsteroidal anti-inflammatory drug ( NSAID ) on pain relief during Pipelle endometrial biopsies in a placebo-controlled randomized study .
METHODS	One hundred and fifty-one women who had an indication for a Pipelle endometrial biopsy were randomized into three groups as follows : group 1 , vaginal misoprostol ; group 2 , rectal NSAID , and group 3 , control .
METHODS	After the procedure , the women were asked to record their pain severity on a visual analog scale .
METHODS	The secondary outcome of the study was patient acceptability , and vasovagal symptoms and analgesic requirements after the procedure were also recorded .
RESULTS	There were no statistically significant differences in the demographic characteristics of the patients .
RESULTS	The primary study outcome was the comparison of the median visual analog scale pain scores of groups 1 and 2 versus group 3 ( controls ) ; no statistically significant differences were found ( p = 0.502 ) .
RESULTS	In addition , the patient acceptability ( Likert scale ) , vasovagal symptoms and analgesic requirements after the procedure were similar among the groups ( p = 0.204 , 1 and 0.546 , respectively ) .
CONCLUSIONS	Our study did not demonstrate a reduction in pain relief during Pipelle endometrial biopsies for patients receiving vaginal misoprostol or a rectal NSAID when compared to patients receiving placebo treatment .

###25867149
BACKGROUND	Bronchiolitis is a public health problem in the word and in Tunisia .
BACKGROUND	Nebulized hypertonic saline seems to have some benefits in bronchiolitis .
BACKGROUND	The aim of this study is to evaluate the efficacy of nebulized 5 % hypertonic saline alone or mixed with epinephrine in bronchiolitis as measured by improvement in clinical score , oxygen saturation or reduction in duration of hospitalization .
METHODS	This prospective , double blind , placebo controlled , randomized clinical trial was performed at Children 's Hospital of Tunis from February 2012 to Mars 2012 .
METHODS	A total of 94 patients less than 12 months of age with diagnosis of moderately severe bronchiolitis were enrolled and assigned to receive 5 % nebulized hypertonic saline , mixed 5 % hypertonic saline with standard epinephrine 0,1 % or normal saline ( placebo ) at admission and every 4 hours during hospitalization .
RESULTS	There were no significant difference between nebulized 5 % hypertonic saline , mixed 5 % hypertonic saline with epinephrine or normal saline at baseline , T30 min , T60 min , and T120 min after start study in Wang severity score , oxygen saturation in room air , rate respiratory and heart rate .
RESULTS	There was no difference in duration of hospitalization .
CONCLUSIONS	Nebulized 5 % hypertonic saline or mixed 5 % hypertonic saline with epinephrine are safety but does not appear effective in treating moderately ill infants with the first acute bronchiolitis .

###24228901
BACKGROUND	Physical exercise and a Mediterranean diet improve serum lipid profile .
BACKGROUND	The present work studied whether red wine has an effect on top of a lipid-lowering lifestyle in patients with carotid atherosclerosis .
METHODS	A prospective randomised unblinded trial was performed from 2009 to 2011 in 108 patients with carotid atherosclerosis , 65 % of whom were already on statin therapy with a low mean LDL of 104.9 mg/dl .
METHODS	Half of them were advised to follow a modified Mediterranean diet and to perform moderate physical exercise during 30 min/day ( lifestyle changes ) for 20 weeks .
METHODS	Within these two groups half of the patients were randomised either to avoid any alcohol or to drink 100 ml of red wine ( women ) or 200 ml of red wine ( men ) daily .
RESULTS	LDL was significantly lowered by 7 % in the lifestyle-changes group compared to the no-lifestyle-changes group ( p = 0.0296 ) after 20 weeks .
RESULTS	Lifestyle changes lowered the LDL/HDL ratio after 20 weeks by 8 % ( p = 0.0242 ) and red wine independently by 13 % ( p = 0.0049 ) .
RESULTS	The effect on LDL/HDL ratio after 20 weeks was , however , more pronounced in the non-LC group .
RESULTS	Total cholesterol ( -6 % ; p = 0.0238 ) and triglycerides ( -13 % ; p = 0.0361 ) were lowered significantly by lifestyle changes after 20 weeks compared to the no-lifestyle-changes group .
RESULTS	Lipoprotein ( a ) was not significantly affected by any intervention .
RESULTS	The given results are per ITT analysis .
CONCLUSIONS	Lifestyle changes including a modified Mediterranean diet and physical exercise as well as a glass of red wine daily improve independently the LDL/HDL ratio in patients with carotid arteriosclerosis even though the vast majority of them was already on statin therapy .

###25153538
BACKGROUND	Patients with non-small-cell lung cancer ( NSCLC ) and ALK rearrangements generally have a progression-free survival of 8-11 months while on treatment with the ALK inhibitor crizotinib .
BACKGROUND	However , resistance inevitably develops , with the brain a common site of progression .
BACKGROUND	More potent ALK inhibitors with consistently demonstrable CNS activity and good tolerability are needed urgently .
BACKGROUND	Alectinib is a novel , highly selective , and potent ALK inhibitor that has shown clinical activity in patients with crizotinib-naive ALK-rearranged NSCLC .
BACKGROUND	We did a phase 1/2 study of alectinib to establish the recommended phase 2 dose of the drug and examine its activity in patients resistant or intolerant to crizotinib .
METHODS	We enrolled patients with ALK-rearranged NSCLC who progressed on or were intolerant to crizotinib .
METHODS	We administered various oral doses of alectinib ( 300-900 mg twice a day ) during the dose-escalation portion of the study ( phase 1 ) , to ascertain the recommended dose for phase 2 .
METHODS	We used Response Evaluation Criteria in Solid Tumors criteria ( version 1.1 ) to investigate the activity of alectinib in all patients with a baseline scan and at least one post-treatment scan ( CT or MRI ) , with central radiological review of individuals with brain metastases .
METHODS	We assessed safety in all patients who received at least one dose of alectinib .
METHODS	Here , we present data for the phase 1 portion of the study , the primary objective of which was to establish the recommended phase 2 dose ; phase 2 is ongoing .
METHODS	This trial is registered at ClinicalTrials.gov , number NCT01588028 .
RESULTS	47 patients were enrolled .
RESULTS	Alectinib was well tolerated , with the most common adverse events being fatigue ( 14 [ 30 % ] ; all grade 1-2 ) , myalgia ( eight [ 17 % ] ; all grade 1-2 ) , and peripheral oedema ( seven [ 15 % ] grade 1-2 , one [ 2 % ] grade 3 ) .
RESULTS	Dose-limiting toxic effects were recorded in two patients in the cohort receiving alectinib 900 mg twice a day ; one individual had grade 3 headache and the other had grade 3 neutropenia .
RESULTS	The most common grade 3-4 adverse events were increased levels of - glutamyl transpeptidase ( two [ 4 % ] ) , a reduction in the number of neutrophils ( two [ 4 % ] ) , and hypophosphataemia ( two [ 4 % ] ) .
RESULTS	Three patients reported four grade 4 serious adverse events that were deemed unrelated to alectinib : acute renal failure ; pleural effusion and pericardial effusion ; and brain metastasis .
RESULTS	At data cut-off ( median follow-up 126 days [ IQR 84-217 ] ) , 44 patients could be assessed for activity .
RESULTS	Investigator-assessed objective responses were noted in 24 ( 55 % ) patients , with a confirmed complete response in one ( 2 % ) , a confirmed partial response in 14 ( 32 % ) , and an unconfirmed partial response in nine ( 20 % ) .
RESULTS	16 ( 36 % ) patients had stable disease ; the remaining four ( 9 % ) had progressive disease .
RESULTS	Of 21 patients with CNS metastases at baseline , 11 ( 52 % ) had an objective response ; six ( 29 % ) had a complete response ( three unconfirmed ) and five ( 24 % ) had a partial response ( one unconfirmed ) ; eight ( 38 % ) patients had stable disease and the remaining two ( 10 % ) had progressive disease .
RESULTS	Pharmacokinetic data indicated that mean exposure ( AUC0-10 ) after multiple doses of alectinib ( 300-600 mg twice a day ) was dose-dependent .
CONCLUSIONS	Alectinib was well tolerated , with promising antitumour activity in patients with ALK-rearranged NSCLC resistant to crizotinib , including those with CNS metastases .
CONCLUSIONS	On the basis of activity , tolerability , and pharmacokinetic data , we chose alectinib 600 mg twice a day as the recommended dose for phase 2 .
BACKGROUND	Chugai Pharmaceuticals , F Hoffmann La-Roche .

###24807084
OBJECTIVE	We assessed long-term mortality and hospitalisation in patients with severe sepsis resuscitated with hydroxyethyl starch ( HES ) or Ringer 's acetate .
METHODS	This was an investigator-initiated , parallel-grouped , blinded randomised trial using computer-generated allocation sequence and centralised allocation data that included 804 patients with severe sepsis needing fluid resuscitation in 26 general intensive care units ( ICUs ) in Scandinavia .
METHODS	Patients were allocated to fluid resuscitation using either 6 % HES 130/0 .42 or Ringer 's acetate during ICU admission .
METHODS	We assessed mortality rates at 6 months , 1 year and at the time of longest follow-up and days alive and out of hospital at 1 year .
RESULTS	The vital status of all patients was obtained at a median of 22 ( range 13-36 ) months after randomisation .
RESULTS	Mortality rates in the HES versus Ringer 's groups at 6 months were 53.3 ( 212/398 patients ) versus 47.5 % ( 190/400 ) [ relative risk 1.12 ; 95 % confidence interval ( CI ) 0.98-1 .29 ; P = 0.10 ] , respectively ; at 1 year , 56.0 ( 223/398 ) versus 51.5 % ( 206/400 ) ( 1.09 ; 95 % CI 0.96-1 .24 ; P = 0.20 ) , respectively ; at the time of longest follow-up , 59.8 ( 238/398 ) versus 56.3 % ( 225/400 ) ( 1.06 ; 95 % CI 0.94-1 .20 ; P = 0.31 ) , respectively .
RESULTS	Percentage of days alive and out of hospital at 1 year in the HES versus Ringer 's groups was 24 ( 0-87 days ) versus 63 % ( 0-90 ) ( P = 0.07 ) .
CONCLUSIONS	The long-term mortality rates did not differ in patients with severe sepsis assigned to HES 130/0 .42 versus Ringer 's acetate , but we could not reject a 24 % relative increased or a 4 % relative decreased mortality at 1 year with HES at the 95 % confidence level .

###24428305
OBJECTIVE	Titrating the dosage of growth hormone ( GH ) to serum levels of insulin-like growth factor-I ( IGF-I ) is a feasible treatment strategy in children with GH deficiency ( GHD ) and idiopathic short stature ( ISS ) .
OBJECTIVE	The objective was to assess the dose-sparing effect and theoretical safety of IGF-I-based GH therapy .
METHODS	This was a post hoc analysis of a previously described 2-year , multicenter , open-label , randomized , outpatient , controlled clinical trial in 172 prepubertal short children [ age 75 24 years ; height standard deviation score ( HSDS ) -264 061 ] classified by baseline peak GH levels as GHD ( < 7 ng/ml ) or ISS ( 7 ng/ml ) .
METHODS	Conventional weight-based dosing of GH ( 004 mg/kg/day ) ( n = 34 ) or GH dosing titrated to an IGF-I target of 0 SDS ( IGF0T ; n = 70 ) or an IGF-I target of +2 SDS ( IGF2T ; n = 68 ) .
METHODS	Change in HSDS per GH mg/kg/day dose ( HSDS/GH dose ratio ) and proportion of IGF-I levels above +2 SDS at the end of 2 years .
RESULTS	GH dosing titrated to an IGF-I target of 0 SDS was the most dose-sparing treatment regimen for GHD or ISS children ( meanSE HSDS/GH dose ratios 481 44 and 325 28 , respectively ) compared with conventional dosing ( 303 66 and 213 35 , respectively ; P = 002 , P = 0005 ) and IGF2T ( 327 48 and 163 28 , respectively ; P = 002 , P < 00001 ) .
RESULTS	IGF0T also resulted in the fewest IGF-I excursions above +2 SDS ( 68 % vs 300 % for conventional dosing ; P < 001 ) .
CONCLUSIONS	IGF-I-based GH dosing , targeted to age - and gender-adjusted means , may offer a more dose-sparing and potentially safer mode of therapy than traditional weight-based dosing .

###24255934
OBJECTIVE	To compare the clinical benefit of a periodontal dressing applied after a one-stage full-mouth disinfection ( OSFMD ) in patients with chronic periodontitis up to 3months after therapy .
METHODS	This randomized , controlled split-mouth study included 24 patients .
METHODS	After OSFMD , a test and a control side were selected by means of a computer-generated randomization list .
METHODS	Test sides received a periodontal dressing ( Coepak ( ) ) for 7days and the control sides received no periodontal dressing .
METHODS	After 7days the periodontal dressing was removed and the pain experience was recorded .
METHODS	After 3months , the clinical periodontal parameters were recorded .
RESULTS	The periodontal dressing group showed a significant ( p < 0.05 ) additional pocket depth reduction and additional clinical attachment gain for the moderate pockets of single - and multi-rooted teeth compared with the control group .
RESULTS	A significant ( p < 0.05 ) lower percentage of sites with probing pocket depth 5mm were shown for the periodontal dressing group compared with the control group ( 2.716.3 % versus 4.821.4 % ) .
RESULTS	The pain intensity was significantly reduced when using a periodontal dressing ( 5.130.89 versus 3.421.27 ) .
CONCLUSIONS	The use of a periodontal dressing for 7days after a OSFMD offers an additional short-term clinical improvement and lowers the pain intensity .

###25326074
BACKGROUND	It was hypothesized that a mobile health ( mHealth ) intervention would elicit greater improvements in systolic blood pressure and other cardiometabolic risk factors at 12weeks , which would be better maintained over 52weeks , compared to the active control intervention .
METHODS	Eligible participants ( 2 metabolic syndrome risk factors ) were randomized to the mHealth intervention ( n = 75 ) or the active control group ( n = 74 ) .
METHODS	Blood pressure and other cardiometabolic risk factors were measured at baseline and at 12 , 24 and 52weeks .
METHODS	Both groups received an individualized exercise prescription and the intervention group additionally received a technology kit for home monitoring of biometrics and physical activity .
RESULTS	Analyses were conducted on 67 participants in the intervention group ( aged 56.79.7 years ; 71.6 % female ) and 60 participants in the active control group ( aged 59.18.4 years ; 76.7 % female ) .
RESULTS	At 12weeks , baseline adjusted mean change in systolic blood pressure ( primary outcome ) was greater in the active control group compared to the intervention group ( -5.68 mmHg ; 95 % CI -10.86 to -0.50 mmHg ; p = 0.03 ) , but there were no differences between groups in mean change for secondary outcomes .
RESULTS	Over 52-weeks , the difference in mean change for systolic blood pressure was no longer apparent between groups , but remained significant across the entire population ( time : p < 0.001 ) .
CONCLUSIONS	In participants with increased cardiometabolic risk , exercise prescription alone had greater short-term improvements in systolic blood pressure compared to the mHealth intervention , though over 52weeks , improvements were equal between interventions .
BACKGROUND	ClinicalTrials.gov http://NCT01944124 .

###25572623
OBJECTIVE	Physicians play a critical role in addressing tobacco dependence , yet report limited training .
OBJECTIVE	Tobacco dependence treatment curricula for medical students could improve performance in this area .
OBJECTIVE	This study identified student and medical school tobacco treatment curricula characteristics associated with intentions and use of the 5As for tobacco treatment among 3rd year U.S. medical students .
METHODS	Third year medical students ( N = 1065 , 49.3 % male ) from 10 U.S. medical schools completed a survey in 2009-2010 assessing student characteristics , including demographics , tobacco treatment knowledge , and self-efficacy .
METHODS	Tobacco curricula characteristics assessed included amount and type of classroom instruction , frequency of tobacco treatment observation , instruction , and perception of preceptors as role models .
RESULTS	Greater tobacco treatment knowledge , self-efficacy , and curriculum-specific variables were associated with 5A intentions , while younger age , tobacco treatment self-efficacy , intentions , and each curriculum-specific variable were associated with greater 5A behaviors .
RESULTS	When controlling for important student variables , greater frequency of receiving 5A instruction ( OR = 1.07 ; 95 % CI 1.01-1 .12 ) and perception of preceptors as excellent role models in tobacco treatment ( OR = 1.35 ; 95 % CI 1.04-1 .75 ) were significant curriculum predictors of 5A intentions .
RESULTS	Greater 5A instruction ( B = .06 ( .03 ) ; p < .05 ) and observation of tobacco treatment ( B = .35 ( .02 ) ; p < .001 ) were significant curriculum predictors of greater 5A behaviors .
CONCLUSIONS	Greater exposure to tobacco treatment teaching during medical school is associated with both greater intentions to use and practice tobacco 5As .
CONCLUSIONS	Clerkship preceptors , or those physicians who provide training to medical students , may be particularly influential when they personally model and instruct students in tobacco dependence treatment .

###25567329
OBJECTIVE	The aim of the study was to compare the effects of aerobic exercise training and yoga on the functional capacity , peripheral muscle strength , quality of life ( QOL ) , and fatigue in breast cancer survivors .
METHODS	A total of 52 patients with a diagnosis of breast cancer were included in the study .
METHODS	The patients were randomly assigned to 2 groups : aerobic exercise ( n = 28 ) and yoga added to aerobic exercise ( n = 24 ) .
METHODS	Both groups participated in submaximal exercise 30 minutes/d , 3 d/wk for 6 weeks .
METHODS	The second group participated in a 1-hour yoga program in addition to aerobic exercise training .
METHODS	Functional capacity was assessed by the 6-Minute Walk Test ( 6MWT ) .
METHODS	Peripheral muscle strength was evaluated with a hand-held dynamometer .
METHODS	The fatigue severity level was assessed with the Fatigue Severity Scale ( FSS ) .
METHODS	The QOL was determined by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire .
RESULTS	There were statistically significant increases in peripheral muscle strength , the 6MWT distance , and the perception of QOL in both groups ( P < .05 ) .
RESULTS	Additionally , the group with aerobic exercise and yoga showed marked improvement compared with the aerobic exercise group in fatigue perception ( P < .05 ) .
CONCLUSIONS	According to the data from this study , aerobic exercise training and yoga improved the functional capacity and QOL of breast cancer patients .
CONCLUSIONS	Aerobic exercise programs can be supported by body mind techniques , such as yoga , in the rehabilitation of cancer patients for improving functional recovery and psychosocial wellness .

###24842806
OBJECTIVE	A very high percentage of patients with severe pelvic endometriosis develop adhesions after laparoscopic surgery .
OBJECTIVE	The objective of this trial was to evaluate the role of ovarian suspension performed during surgery for severe endometriosis on ovarian adhesions and postoperative pelvic pain .
METHODS	A randomized controlled trial ( Canadian Task Force classification I ) .
METHODS	The tertiary care University Hospital of Bologna , Bologna , Italy .
METHODS	Eighty patients with ovarian and posterior deep infiltrating endometriosis were included in the study .
METHODS	Patients underwent laparoscopic surgery for endometriosis and were randomized sequentially into 2 groups : transient ovarian suspension was performed in the treatment group ( n = 40 ) , whereas in the control group ( n = 40 ) ovaries were left free in the pelvis .
METHODS	Symptom intensity ( dysmenorrhea , chronic pelvic pain , dyspareunia , dyschezia , and dysuria ) were ranked using a visual analog scale .
METHODS	Postsurgical ovarian adhesions were evaluated using transvaginal ultrasonographic scans performed by an ultrasound operator who was blinded to the details of the operative procedure and women 's randomization allocation .
METHODS	Complications , lesion localization , endometrioma diameter , and surgery time were recorded .
RESULTS	At follow-up , a significantly lower rate of ultrasound-detectable ovarian adhesions with the uterus and the bowel was observed in the treatment group , respectively ( 46.7 % vs 77.3 % , p = .003 and 26.7 % vs 68.2 % , p < .0005 ) .
RESULTS	Patients in the control group showed a higher percentage of fixed ovaries with moderate and severe adhesions than the treatment group , respectively ( 56.8 % vs 28.9 % , p = .003 and 20.5 % vs 8.9 % , p = .110 ) .
RESULTS	No differences between the 2 groups were found regarding complications and pelvic pain .
CONCLUSIONS	Ovarian suspension seems to be an additional effective surgical procedure associated with an increased ovarian mobility in women treated for severe endometriosis .
CONCLUSIONS	Moreover , it is feasible , safe , simple , and fast .
CONCLUSIONS	Hence , it should be routinely used during laparoscopic surgery for endometriosis .

###24823280
BACKGROUND	Insulin therapy should be strongly considered in newly diagnosed type 2 diabetic ( T2D ) patients with severe hyperglycemia .
BACKGROUND	However , whether insulin be continued or patients switched to an oral antidiabetic drug ( OAD ) after short-term intensive insulin therapy ( ITT ) is not clear .
METHODS	After ITT for 10-14 days , 47 patients were randomized into either a glargine ( n = 21 ) or metformin-based OAD ( n = 26 ) group for a 6-month intervention .
METHODS	After these 6 months , patients in the glargine group were switched to metformin-based OAD therapy , whereas treatment in the OAD group was unchanged .
METHODS	Patients were followed-up for another 6 months .
RESULTS	At the end of the 6-month intervention , HbA1c was similarly reduced in both the glargine ( from 11.811.70 % to 6.480.79 % ; P < 0.001 ) and OAD ( from 11.711.89 % to 6.160.52 % ; P < 0.001 ) groups .
RESULTS	At the end of 12 months , HbA1c was at comparable and near optimal levels in both groups .
RESULTS	Similar increases were seen in homeostatic model assessment of - cell function in the two groups after 6 months .
RESULTS	There were no significant differences between the two groups in insulin sensitivity improvement , hypoglycemic episodes , weight change , treatment satisfaction and quality of life after the 6-month intervention .
CONCLUSIONS	The effects of metformin-based OAD therapy on glycemic control and improvements in - cell function are not inferior to glargine in newly diagnosed T2D patients with severe hyperglycemia after short-term ITT .
CONCLUSIONS	Considering the superiority of metformin in terms of safety , cost , and convenience , metformin-based OAD therapy is strongly recommended for these patients .

###25367403
BACKGROUND	Group psychosocial interventions including mindfulness-based cancer recovery ( MBCR ) and supportive-expressive group therapy ( SET ) can help breast cancer survivors decrease distress and influence cortisol levels .
BACKGROUND	Although telomere length ( TL ) has been associated with breast cancer prognosis , the impact of these two interventions on TL has not been studied to date .
METHODS	The objective of the current study was to compare the effects of MBCR and SET with a minimal intervention control condition ( a 1-day stress management seminar ) on TL in distressed breast cancer survivors in a randomized controlled trial .
METHODS	MBCR focused on training in mindfulness meditation and gentle Hatha yoga whereas SET focused on emotional expression and group support .
METHODS	The primary outcome measure was relative TL , the telomere/single-copy gene ratio , assessed before and after each intervention .
METHODS	Secondary outcomes were self-reported mood and stress symptoms .
RESULTS	Eighty-eight distressed breast cancer survivors with a diagnosis of stage I to III cancer ( using the American Joint Committee on Cancer ( AJCC ) TNM staging system ) who had completed treatment at least 3 months prior participated .
RESULTS	Using analyses of covariance on a per-protocol sample , there were no differences noted between the MBCR and SET groups with regard to the telomere/single-copy gene ratio , but a trend effect was observed between the combined intervention group and controls ( F [ 1,84 ] , 3.82 ; P = .054 ; ( 2 ) = .043 ) ; TL in the intervention group was maintained whereas it was found to decrease for control participants .
RESULTS	There were no associations noted between changes in TL and changes in mood or stress scores over time .
CONCLUSIONS	Psychosocial interventions providing stress reduction and emotional support resulted in trends toward TL maintenance in distressed breast cancer survivors , compared with decreases in usual care .

###25202955
OBJECTIVE	To evaluate the influence of perioperative intravenous administration of ambroxol on pulmonary function , postoperative complications , postoperative hospital stay , and cost after video-assisted thoracic surgery lobectomy for lung cancer .
METHODS	Sixty patients who underwent video-assisted thoracic surgery lobectomy for lung cancer in Xiangya Hospital , Central South University between May 2011 and May 2012 were randomly assigned into 2 groups : An ambroxol group ( n = 30 ) and a control group ( n = 30 ) .
METHODS	In the ambroxol group , patients were given ambroxol ( 1 000 mg/d ) on the day of operation and on the first 3 postoperative days .
METHODS	In control group , placebo was given .
METHODS	The pulmonary function tests , arterial blood gases , incidence of perioperative morbidity , postoperative mechanical ventilation time , duration of ICU stay , length and costs of postoperative hospital stay were compared between the 2 groups .
RESULTS	The 2 groups were well matched for demographics and operative variables .
RESULTS	The ambroxol group showed better the percent predicted forced expiratory volume in 1 second ( FEV1 % ) , the ratio of forced expiratory volume in 1 second to forced vital capacity ( FEV1/FVC % ) , the percent predicted diffusing capacity of the lung for carbon monoxide ( DLCO % ) and arterial oxygen pressure than the control group .
RESULTS	The postoperative pulmonary complications was significantly reduced , the duration of mechanical ventilation and the length of ICU stay were shortened , and the length and costs of postoperative hospital stay were significantly decreased in the ambroxol group compared with the control group ( all P < 0.05 ) .
CONCLUSIONS	Perioperative intravenous administration of ambroxol can improve the postoperative lung function , reduce the incidence of pulmonary complications , shorten the length of postoperative hospital stay , and lower the total cost of hospitalization after video-assisted thoracic surgery lobectomy for lung cancer .

###25619124
BACKGROUND	Several agents have been tried in the management of mastalgia .
BACKGROUND	Centchroman ( Ormeloxifene ) , a novel non-steroidal selective estrogen receptor modulator ( SERM ) , has also been recently used in the management of mastalgia .
METHODS	Eligible patients , who had mastalgia for more than 3 months , were randomized into two groups - Group A received centchroman 30 mg daily and Group B received tamoxifen 10 mg daily .
METHODS	Treatment was continued for a total of 12 weeks ; thereafter , patients were followed for another 12 weeks without medication to assess the continuum of relief .
METHODS	Pain severity was measured with VAS score .
METHODS	Patients were considered to have complete pain relief if their VAS score decreased to 3 or less .
RESULTS	Patients , in both the groups , showed gradual improvement in mastalgia with passage of time up to 12 weeks .
RESULTS	Following cessation of treatment at 12 weeks , partial relapse of pain was observed at 24 weeks .
RESULTS	There was no significant difference between Group A and Group B in terms of mean VAS Score and proportion of women reporting pain relief at 4 , 8 , 12 , and 24 weeks .
RESULTS	Fifteen patients in Group A had side effects namely dizziness , menstrual irregularities and development of ovarian cysts .
RESULTS	There was no side effect noted in group B.
CONCLUSIONS	Centchroman and tamoxifen were found to be of similar effectiveness in providing pain relief in mastalgia .
CONCLUSIONS	High frequency of side effects , particularly development of ovarian cyst , in patients receiving centchroman is a matter of concern .

###24732649
BACKGROUND	Nasoalveolar molding became increasingly popular in the 1990s as a means of easing surgery and improving nasal outcomes for cleft lip repairs .
BACKGROUND	In the late 1990s , three orthodontists from our center underwent nasoalveolar molding training : two at the Rush Craniofacial Center , in Chicago ; and one at New York University Craniofacial Center .
BACKGROUND	They brought two different nasoalveolar molding techniques back to Chang Gung Craniofacial Center : the modified Figueroa and the modified Grayson techniques .
BACKGROUND	Outcomes following use of these techniques have not previously been compared prospectively .
METHODS	Between May of 2010 and March of 2013 , a randomized , prospective , single-blind trial was conducted to compare the number of clinical visits , total costs , complications , and nasal symmetry between the two nasoalveolar molding techniques in 30 patients with unilateral complete cleft lip .
RESULTS	There were no differences between nasoalveolar molding techniques in the number of clinical visits , total costs , nostril height , or nostril area ratio .
RESULTS	Preoperatively but after nasoalveolar molding , the nostril width ratio was wider for the Figueroa group than for the Grayson group .
RESULTS	Six months after surgical correction , there were no differences in nostril height , nostril width , nasal sill height , or nostril area ratio between nasoalveolar molding methods .
RESULTS	Alveolar ulceration occurred more frequently in the Grayson group .
CONCLUSIONS	The modified Grayson technique reduced nostril width more efficiently , but alveolar ulceration was more frequent and no differences in nostril width were found following surgery .
CONCLUSIONS	Overall , the two nasoalveolar molding techniques produced similar nasal outcomes .
METHODS	Therapeutic , II .

###26035702
BACKGROUND	This analysis compared the quality-adjusted survival and clinical outcomes of albumin-bound paclitaxel + carboplatin ( nab-PC ) vs solvent-based paclitaxel + carboplatin ( sb-PC ) as first-line therapy in advanced non-small-cell lung cancer ( NSCLC ) in older patients .
METHODS	Using age-based subgroup data from a randomised Phase-3 clinical trial , nab-PC and sb-PC were compared with respect to overall response rate ( ORR ) , overall survival ( OS ) , progression-free survival ( PFS ) , quality of life ( QoL ) , safety/toxicity , and quality-adjusted time without symptoms or toxicity ( Q-TWiST ) with ages 60 and 70 years as cut points .
RESULTS	Among patients aged 60 years ( N = 546 ) , nab-PC ( N = 265 ) significantly increased ORR and prolonged OS , despite a non-significant improvement in PFS , vs sb-PC ( N = 281 ) .
RESULTS	Nab-PC improved QoL and was associated with less neuropathy , arthralgia , and myalgia but resulted in more anaemia and thrombocytopenia .
RESULTS	Nab-PC yielded significant Q-TWiST benefits ( 11.1 vs 9.8 months ; 95 % CI of gain : 0.2-2 .6 ) , with a relative Q-TWiST gain of 10.8 % ( ranging from 6.4 % to 15.1 % in threshold analysis ) .
RESULTS	In the 70 years age group , nab-PC showed similar , but non-significant , ORR , PFS , and Q-TWiST benefits and significantly improved OS and QoL .
CONCLUSIONS	Nab-PC as first-line therapy in older patients with advanced NSCLC increased ORR , OS , and QoL and resulted in quality-adjusted survival gains compared with standard sb-PC .

###25464263
BACKGROUND	To test the use of three lead monitoring as a screening tool for atrial fibrillation ( AF ) in general practice .
BACKGROUND	AF is responsible for up to a quarter of all strokes and is often asymptomatic until a stroke occurs .
METHODS	26 randomly selected general practices identified 80 randomly selected patients aged 70 or older from their database and excluded those known to have AF , those with clinical issues or who had not attended for three years .
METHODS	Up to 40 eligible patients/practice were invited to attend for screening .
METHODS	A 2min three-lead ECG was recorded and collected centrally for expert cardiology assessment .
METHODS	Risk factor data was gathered .
RESULTS	( i ) point prevalence of AF , ( ii ) proportion of ECG tracings which were adequate for interpretation , ( iii ) uptake rate by patients and ( iv ) acceptability of the screening process to patients and staff ( reported separately ) .
RESULTS	Of 1447 current patients , 1003 were eligible for inclusion , 639 ( 64 % ) agreed to take part in screening and 566 ( 56 % ) completed screening .
RESULTS	The point prevalence rate for AF was 10.3 % -2.1 % new cases ( 12 of 566 who were screened ) and 9.5 % existing cases ( 137 of 1447 eligible patients ) .
RESULTS	Only four of 570 ( 0.7 % ) screening visits did not record a usable ECG and 11 ( 2.6 % ) three lead ECGs required a clarifying 12 lead ECG .
CONCLUSIONS	Three lead screening for AF is feasible , effective and offers an alternative to pulse taking or 12 lead ECGs .
CONCLUSIONS	The availability of this technology may facilitate more effective screening , leading to reduced stroke incidence .

###24576912
BACKGROUND	Prehospital identification of acute stroke increases the possibility of early treatment and good outcome .
BACKGROUND	To increase identification of stroke , the Face Arm Speech Time ( FAST ) test was introduced in the Emergency Medical Communication Center ( EMCC ) .
BACKGROUND	This substudy aims to evaluate the implementation of the FAST test in the EMCC and the ambulance service .
METHODS	The study was conducted in the region of Stockholm , Sweden during 6 months .
METHODS	The study population consisted of all calls to the EMCC concerning patients presenting at least one FAST symptom or a history/finding making the EMCC or ambulance personnel to suspect stroke within 6 h. Positive FAST was compared to diagnosis at discharge .
METHODS	Positive predictive values ( PPV ) for a stroke diagnosis at discharge were calculated .
RESULTS	In all , 900 patients with a median age of 71 years were enrolled , 667 ( 74 % ) by the EMCC and 233 ( 26 % ) by the ambulances .
RESULTS	At discharge , 472 patients ( 52 % ) were diagnosed with stroke/transient ischemic attack ( TIA ) , 337 identified by the EMCC ( 71 % ) and 135 ( 29 % ) by the ambulances .
RESULTS	The PPV for a discharge diagnosis of stroke/TIA was 51 % ( CI 47-54 % ) in EMCC-enrolled and 58 % ( CI 52-64 % ) in ambulance-enrolled patients .
RESULTS	With a positive FAST the PPV of a correct stroke/TIA diagnosis increased to 56 % ( CI 52-61 % ) and 73 % ( CI 66-80 % ) in EMCC - and ambulance-enrolled patients , respectively .
RESULTS	Positive FAST from EMCC was also found in 44 % of patients with a nonstroke diagnosis at discharge .
RESULTS	A stroke/TIA diagnosis at discharge but negative FAST was found in 58 and 27 patients enrolled by the EMCC and ambulances , respectively .
CONCLUSIONS	The PPV of FAST is higher when used on the scene by ambulance than by EMCC .
CONCLUSIONS	FAST may be a useful prehospital tool to identify stroke/TIA but has limitations as the test can be negative in true strokes , can be positive in nonstrokes , and FAST symptoms may be present but not identified in the emergency call .
CONCLUSIONS	For the prehospital care situation better identification tools are needed .

###25158274
OBJECTIVE	Few studies have characterized longer-term outcomes after retropubic and transobturator mid urethral slings .
METHODS	Women completing 2-year participation in a randomized equivalence trial who had not undergone surgical re-treatment for stress urinary incontinence were invited to participate in a 5-year observational cohort .
METHODS	The primary outcome , treatment success , was defined as no re-treatment or self-reported stress incontinence symptoms .
METHODS	Secondary outcomes included urinary symptoms and quality of life , satisfaction , sexual function and adverse events .
RESULTS	Of 597 women 404 ( 68 % ) from the original trial enrolled in the study .
RESULTS	Five years after surgical treatment success was 7.9 % greater in women assigned to the retropubic sling compared to the transobturator sling ( 51.3 % vs 43.4 % , 95 % CI -1.4 , 17.2 ) , not meeting prespecified criteria for equivalence .
RESULTS	Satisfaction decreased during 5 years but remained high and similar between arms ( retropubic sling 79 % vs transobturator sling 85 % , p = 0.15 ) .
RESULTS	Urinary symptoms and quality of life worsened with time ( p < 0.001 ) , and women with a retropubic sling reported greater urinary urgency ( p = 0.001 ) , more negative impact on quality of life ( p = 0.02 ) and worse sexual function ( p = 0.001 ) .
RESULTS	There was no difference in the proportion of women experiencing at least 1 adverse event ( p = 0.17 ) .
RESULTS	Seven new mesh erosions were noted ( retropubic sling 3 , transobturator sling 4 ) .
CONCLUSIONS	Treatment success decreased during 5 years for retropubic and transobturator slings , and did not meet the prespecified criteria for equivalence with retropubic demonstrating a slight benefit .
CONCLUSIONS	However , satisfaction remained high in both arms .
CONCLUSIONS	Women undergoing a transobturator sling procedure reported more sustained improvement in urinary symptoms and sexual function .
CONCLUSIONS	New mesh erosions occurred in both arms over time , although at a similarly low rate .

###24618964
OBJECTIVE	More than 300,000 surgeries are performed annually in the United States for pelvic organ prolapse .
OBJECTIVE	Sacrospinous ligament fixation ( SSLF ) and uterosacral ligament suspension ( ULS ) are commonly performed transvaginal surgeries to correct apical prolapse .
OBJECTIVE	Little is known about their comparative efficacy and safety , and it is unknown whether perioperative behavioral therapy with pelvic floor muscle training ( BPMT ) improves outcomes of prolapse surgery .
OBJECTIVE	To compare outcomes between ( 1 ) SSLF and ULS and ( 2 ) perioperative BPMT and usual care in women undergoing surgery for vaginal prolapse and stress urinary incontinence .
METHODS	Multicenter , 22 factorial , randomized trial of 374 women undergoing surgery to treat both apical vaginal prolapse and stress urinary incontinence was conducted between 2008 and 2013 at 9 US medical centers .
METHODS	Two-year follow-up rate was 84.5 % .
METHODS	The surgical intervention was transvaginal surgery including midurethral sling with randomization to SSLF ( n = 186 ) or ULS ( n = 188 ) ; the behavioral intervention was randomization to receive perioperative BPMT ( n = 186 ) or usual care ( n = 188 ) .
METHODS	The primary outcome for the surgical intervention ( surgical success ) was defined as ( 1 ) no apical descent greater than one-third into vaginal canal or anterior or posterior vaginal wall beyond the hymen ( anatomic success ) , ( 2 ) no bothersome vaginal bulge symptoms , and ( 3 ) no re-treatment for prolapse at 2 years .
METHODS	For the behavioral intervention , primary outcome at 6 months was urinary symptom scores ( Urinary Distress Inventory ; range 0-300 , higher scores worse ) , and primary outcomes at 2 years were prolapse symptom scores ( Pelvic Organ Prolapse Distress Inventory ; range 0-300 , higher scores worse ) and anatomic success .
RESULTS	At 2 years , surgical group was not significantly associated with surgical success rates ( ULS , 59.2 % [ 93/157 ] vs SSLF , 60.5 % [ 92/152 ] ; unadjusted difference , -1.3 % ; 95 % CI , -12.2 % to 9.6 % ; adjusted odds ratio [ OR ] , 0.9 ; 95 % CI , 0.6 to 1.5 ) or serious adverse event rates ( ULS , 16.5 % [ 31/188 ] vs SSLF , 16.7 % [ 31/186 ] ; unadjusted difference , -0.2 % ; 95 % CI , -7.7 % to 7.4 % ; adjusted OR , 0.9 ; 95 % CI , 0.5 to 1.6 ) .
RESULTS	Perioperative BPMT was not associated with greater improvements in urinary scores at 6 months ( adjusted treatment difference , -6.7 ; 95 % CI , -19.7 to 6.2 ) , prolapse scores at 24 months ( adjusted treatment difference , -8.0 ; 95 % CI , -22.1 to 6.1 ) , or anatomic success at 24 months .
CONCLUSIONS	Two years after vaginal surgery for prolapse and stress urinary incontinence , neither ULS nor SSLF was significantly superior to the other for anatomic , functional , or adverse event outcomes .
CONCLUSIONS	Perioperative BPMT did not improve urinary symptoms at 6 months or prolapse outcomes at 2 years .
BACKGROUND	clinicaltrials.gov Identifier : NCT00597935 .

###24918556
BACKGROUND	Minocycline and lymecycline are used in the treatment of acne , but there is not enough evidence to support superior efficacy of one of them .
METHODS	170 participants from 14 to 34 years old with mild to moderate facial acne vulgaris were recruited .
METHODS	84 had 100 mg of minocycline in a single daily dose for 8 weeks and 86 had 300 mg of lymecycline in a single daily dose for 8 weeks .
METHODS	Participants were evaluated at baseline , week 4 and week 8 .
RESULTS	65 minocycline and 60 lymecycline patients were evaluable .
RESULTS	The last observation carried forward for the count of non-inflammatory lesions changed from 37.5 17.8 to 37.7 17.8 in the minocycline group and from 36.9 15.5 to 33.4 19.3 in the lymecycline group ( no significant changes ) ; corresponding changes in inflammatory lesions were from 19.4 12.4 to 12.2 10.0 in the minocycline group and from 20.1 11.3 to 12.6 8.4 in lymecycline group ( P < 0.05 comparing baseline vs. final in both groups ) .
RESULTS	Porphyrin counts varied from 899.5 613.9 to 233.5 219.5 in the minocycline group and from 956.9 661.8 to 411.8 411.5 in the lymecycline group ( P < 0.05 between the groups at study end ) .
RESULTS	36 ( 42.9 % ) patients receiving minocycline suffered 55 adverse events ( 22 of them gastrointestinal ) , while 28 ( 33.3 % ) lymecycline patients had 37 adverse events ( 15 of them gastrointestinal ) .
RESULTS	One patient in the lymecycline group withdrew the study due to gastritis , and one more patient in the same group experienced eosinophilia .
CONCLUSIONS	There were no differences between the groups in non-inflammatory and inflammatory lesion counts , and in the safety profile .
CONCLUSIONS	Treatment with minocycline induced statistically significant decrease in facial porphyrin counts compared to the group treated with lymecycline ( ClinicalTrials.gov number , NCT00988026 ) .

###25500488
BACKGROUND	Experimental studies have shown that liposomal curcumin can exert a reduction in tumor growth in pancreatic and colorectal cancer .
BACKGROUND	In this phase I clinical trial we investigated the pharmacokinetics , safety , and tolerability of intravenously administered liposomal curcumin in healthy subjects .
METHODS	50 male and female participants were included in this randomized , placebo-controlled double-blind phase I dose escalation study .
METHODS	Subjects received a single dose of liposomal curcumin ( 10 - 400 mg/m2 ; n = 2 - 6 per group ) or placebo over 2 hours intravenously .
RESULTS	Dose-dependent increases in the plasma concentrations of curcumin and its metabolite tetrahydrocurcumin ( THC ) were detected .
RESULTS	After the end of drug infusion , curcumin and THC plasma concentrations decreased within 6 - 60 minutes below the limit of quantification .
RESULTS	Mean urinary excretion was ~ 0.1 % of total systemic clearance .
RESULTS	Liposomal curcumin was tolerated well , but a transient red blood cell echinocyte formation with concomitant increase in mean cellular volume was observed at dosages 120 mg/m2 .
CONCLUSIONS	Short-term intravenous dosing of liposomal curcumin appears to be safe up to a dose of 120 mg/m2 .
CONCLUSIONS	Changes in red blood cell morphology may represent a dose limiting sign of toxicity .

###24906437
OBJECTIVE	The effectiveness and tolerability of tapentadol extended release ( ER ) , a centrally acting analgesic with - opioid receptor agonist and norepinephrine ( noradrenaline ) reuptake inhibitor activities , have been demonstrated in patients with chronic pain , including those switching directly from prior opioid therapy .
OBJECTIVE	The objective of the current study was to evaluate the effectiveness and safety of conversion to oral tapentadol ER ( 50-250 mg twice daily ) from previous around-the-clock strong opioid therapy in patients with moderate to severe , chronic malignant tumor-related cancer pain that was well-controlled .
METHODS	This randomized , open-label , phase III study , which was conducted in Japan , included a 1 - to 2-week screening period ( on previous opioid ) and an 8-week , open-label treatment period .
METHODS	Eligible patients , who were taking a strong opioid analgesic and had a mean pain intensity score < 4 during the 3 days prior to randomization ( adequate pain control on previous strong opioid ) , were randomized ( 1:1 ) to receive twice-daily treatment with tapentadol ER ( 100-500 mg/day ) or morphine sustained release ( SR ; 20-140 mg/day ; reference for assay sensitivity ) .
METHODS	Initial doses were estimated based on the conversion ratio of tapentadol ER : oxycodone : morphine : fentanyl = 10:2:3:0.03 .
METHODS	The primary effectiveness endpoint was the proportion of patients who maintained pain control [ change from baseline in mean pain intensity ( 11-point numerical rating scale ) less than +1.5 for 3 consecutive days and no more than two doses of rescue medication per day for 3 consecutive days ) during the first week of open-label treatment .
RESULTS	In the tapentadol ER group ( n = 50 ) , 84.0 % of patients ( 42/50 ; 95 % CI , 70.89-92 .83 ) maintained pain control during Week 1 .
RESULTS	On the Patient Global Impression of Change , 2.1 % ( 1/48 ) , 2.1 % ( 1/48 ) , 22.9 % ( 11/48 ) , and 50.0 % ( 24/48 ) of patients in the tapentadol ER group reported that their overall condition was `` very much improved , '' `` much improved , '' `` minimally improved , '' and `` not changed , '' respectively , at Week 1 compared with 0 % , 10.7 % ( 3/28 ) , 28.6 % ( 8/28 ) , and 53.6 % ( 15/28 ) reporting these ratings at Week 8 .
RESULTS	The sensitivity of effectiveness analyses was validated based on results using morphine SR ; 98.0 % ( 49/50 ; 95 % CI , 89.35-99 .95 ) of patients in the morphine SR group maintained pain control after 1 week of treatment .
RESULTS	The overall safety profile was similar to that demonstrated in previous studies ; tapentadol ER was associated with a lower incidence of gastrointestinal treatment-emergent adverse events than morphine SR [ 38.0 % ( 19/50 ) vs. 54.0 % ( 27/50 ) ] , including constipation [ 12.0 % ( 6/50 ) vs. 20.0 % ( 10/50 ) ] and vomiting [ 6.0 % ( 3/50 ) vs. 26.0 % ( 13/50 ) ] .
CONCLUSIONS	Overall , results indicate that conversion from previous strong opioids to tapentadol ER ( 50-250 mg twice daily ) was successful and resulted in safe and effective pain control with improved gastrointestinal tolerability versus morphine SR in patients with moderate to severe cancer-related pain that was well-controlled on their previous opioid .

###25505191
BACKGROUND	Antipsychotic drugs frequently cause amenorrhoea and galactorrhoea .
BACKGROUND	Jasmine flowers used topically were as effective as oral Bromocriptine in suppressing puerperal lactation .
BACKGROUND	This study aims to evaluate the efficacy and safety of intranasal jasmine flower extract ( JFE ) to reduce prolactin levels of patients on stable doses of antipsychotic drugs .
METHODS	This is a randomized , double blind , crossover clinical trial .
METHODS	An aqueous-ethanol extract of jasmine flowers was prepared and used as nasal drops .
METHODS	A decrease in serum prolactin of 25ng/mL was considered a significant response .
RESULTS	Ten out of 35 women had a significant drop in the serum prolactin while on the JFE .
RESULTS	The non-responders to JFE were on higher doses of antipsychotic drugs .
RESULTS	The main side effect was a transient and mild burning sensation in the nose .
RESULTS	A cost analysis favoured JFE over dopamine agonists .
CONCLUSIONS	JFE contains a prolactin-lowering substance which needs further characterisation .

###25875753
OBJECTIVE	To evaluate the recurrence of common bile duct stones and risk factors for recurrence following routine endoscopic sphincterotomy ( EST ) versus small-incision endoscopic sphincterotomy plus endoscopic papillary balloon dilation ( EST-EPBD ) .
METHODS	Three hundred patients who were hospitalized between June 2007 and June 2008 with common bile duct stones > 10 mm in diameter were randomly assigned to the EST or EST-EPBD group .
METHODS	We compared the short-term ( 3 years ) and long-term ( > 3 years ) recurrence of ductal stones in the two groups over a 72-month follow-up period .
METHODS	Potential risk factors were evaluated using a logistic regression analysis .
RESULTS	A total of 291 patients completed the study .
RESULTS	The short-term recurrence rate in the EST group was not significantly higher than that in the EST-EPBD group ( P > 0.05 ) .
RESULTS	The long-term recurrence rate for the EST group was significantly higher than that for the EST-EPBD group ( P < 0.05 ) .
RESULTS	The serum level of cholesterol , body mass index , gallstones , maximum stone diameter , number of stones , and mechanical lithotripsy were risk factors for the recurrence of ductal stones .
RESULTS	Minimal size of the duodenal papilla incision was a protective factor with regard to the recurrence of ductal stones .
RESULTS	Cholecystectomy , sex , and age were not associated with the recurrence of ductal stones .
CONCLUSIONS	Small-incision EST-EPBD has a similar overall success rate and a significantly lower rate of the recurrence of ductal stones , compared with those of EST alone .
CONCLUSIONS	Thus , the curative effect of EST-EPBD is better than that of EST alone .
CONCLUSIONS	Minimal size of the duodenal papilla incision protects against the recurrence of ductal stones .

###24374263
OBJECTIVE	To find out whether in varicocele embolization the copolymer cyanoacrylate glue ( NBCA-MS ) has a better patient tolerance compared to the monomer n-butyl-2-cyanoacrylate ( NBCA ) .
METHODS	N = 112 insufficient spermatic veins ( left sided N = 84 , right sided N = 28 ) diagnosed in N = 83 adult males were prospectively randomized for blinded embolization with either NBCA N = 54 ( Histoacryl ) or with NBCA-MS N = 58 ( Glubran2 ) .
METHODS	Before , during and up to one week after embolization , patient discomfort was assessed by a standardized pain scale .
METHODS	Type , location and side of discomfort were noted .
METHODS	Statistical analysis was performed with the Mann-Whitney U-test , the McNemar test and the Fisher 's exact test .
RESULTS	Embolization caused discomfort in N = 48/112 ( 43 % ) spermatic veins , comprising N = 26/54 ( 48 % ) in the NBCA group and N = 22/58 ( 38 % ) in the NBCA-MS group .
RESULTS	During the week after embolization , the overall number of discomfort reports rose to N = 62/106 ( 59 % ) , with an increase to N = 30/53 ( 57 % ) in the NBCA group and to N = 32/53 ( 60 % ) in the NBCA-MS group .
RESULTS	The number of immediate grade 2 to 4 pain reactions was N = 22/112 ( 20 % ) , and rose to N = 37/106 ( 35 % ) after one week .
RESULTS	No difference in discomfort during embolization and at 1 week after treatment was noted .
RESULTS	Characteristics , severity grading , and location of discomfort were similar in both NBCA groups , regardless the time point of observation .
CONCLUSIONS	Discomfort after glue embolization of varicocele is a common side effect , which might evolve to pain .
CONCLUSIONS	The assumed lower inflammatory reaction on NBCA-MS was not translated in an improved tolerance .

###24326013
BACKGROUND	The aim of this prospective clinical study was to compare the mean durability and the failure rates of two types of orthodontic retainers .
METHODS	Orthodontic patients ( 142 ) aged between 14 and 28 years were recruited in this study .
METHODS	The polyethylene woven ribbon ( Ribbond , Seattle , WA , USA ) retainer was compared with a 0.0175-in flexible spiral wire ( Respond , Ormco , Glendora , CA , USA ) retainer .
METHODS	When treatment was completed , the retainers were bonded from canine to canine in the maxillary and the mandibular arches of the participants .
METHODS	In the follow-up visits , the patients were re-evaluated every 3 months over a period of 18 months .
METHODS	The time taken for the retainers to remain without any fracture was appraised .
METHODS	Kaplan-Meier analysis and the logrank test were employed to identify significant differences in the survival functions between the groups .
METHODS	The rates of the retainers ' failure between the groups were analyzed using Chi-square test .
RESULTS	It was revealed that the mean survival of the flexible spiral wire retainer was 15.340.47 and 15.600.42 months in the maxillary and mandibular arches , respectively .
RESULTS	The mean survival of the ribbon retainer was 13.950.55 and 14.260.57 months in the maxillary and mandibular arches , respectively .
RESULTS	Ribbon retainers showed a failure rate of 50 % in the maxillary and 42.6 % in the mandibular arches .
RESULTS	Flexible spiral retainers showed a failure rate of 36.5 % in the maxillary and 37.8 % in the mandibular arches .
RESULTS	The differences were not statistically significant .
RESULTS	Regarding the evaluation period , the differences had limited clinical significance .
CONCLUSIONS	The mean survival time and the failure rates of the polyethylene woven ribbon retainer were comparable to the flexible spiral wire retainer during the 18 months after orthodontic treatment .

###24787494
BACKGROUND	Low-glycemic index ( GI ) diets have been proven to have beneficial effects in such chronic conditions as type 2 diabetes , ischemic heart disease , and some types of cancer , but the effect of low-GI diets on weight loss , satiety , and inflammation is still controversial .
OBJECTIVE	We assessed the efficacy of 2 moderate-carbohydrate diets and a low-fat diet with different GIs on weight loss and the modulation of satiety , inflammation , and other metabolic risk markers .
METHODS	The GLYNDIET study is a 6-mo randomized , parallel , controlled clinical trial conducted in 122 overweight and obese adults .
METHODS	Participants were randomly assigned to one of the following 3 isocaloric energy-restricted diets for 6 mo : 1 ) a moderate-carbohydrate and high-GI diet ( HGI ) , 2 ) a moderate-carbohydrate and low-GI diet ( LGI ) , and 3 ) a low-fat and high-GI diet ( LF ) .
RESULTS	At weeks 16 and 20 and the end of the intervention , changes in body mass index ( BMI ; in kg/m ( 2 ) ) differed significantly between intervention groups .
RESULTS	Reductions in BMI were greater in the LGI group than in the LF group , whereas in the HGI group , reductions in BMI did not differ significantly from those in the other 2 groups ( LGI : -2.45 0.27 ; HGI : -2.30 0.27 ; LF : -1.43 0.27 ; F = 4.616 , P = 0.012 ; pairwise comparisons : LGI compared with HGI , P = 1.000 ; LGI compared with LF , P = 0.016 ; HGI compared with LF , P = 0.061 ) .
RESULTS	The decrease in fasting insulin , homeostatic model assessment of insulin resistance , and homeostatic model assessment of cell function was also significantly greater in the LGI group than in the LF group ( P < 0.05 ) .
RESULTS	Despite this tendency for a greater improvement with a low-GI diet , the 3 intervention groups were not observed to have different effects on hunger , satiety , lipid profiles , or other inflammatory and metabolic risk markers .
CONCLUSIONS	A low-GI and energy-restricted diet containing moderate amounts of carbohydrates may be more effective than a high-GI and low-fat diet at reducing body weight and controlling glucose and insulin metabolism .
CONCLUSIONS	This trial was registered at Current Controlled Trials ( www.controlled-trials.com ) as ISRCTN54971867 .

###25673442
BACKGROUND	Although repair augmented with mesh has been proved its priority in anatomical and functional recovery after anterior compartment reconstruction , the data about posterior compartment are scarce .
BACKGROUND	The aim of this study was to compare bowel functional outcome of posterior vaginal compartment repair with and without mesh in patients with pelvic organ prolapse ( POP ) .
METHODS	This was a prospective , double-blind , clinical pilot study of 22 postmenopausal women with symptomatic POP ( overall POP-quantification [ POP-Q ] Stage III-IV ) who underwent total pelvic floor reconstruction .
METHODS	Patients were grouped according to the use of mesh for posterior vaginal compartment repair : A mesh group and a nonmesh group .
METHODS	POP-Q stage , the pelvic floor impact questionnaire short form-7 ( PFIQ-7 ) and anorectal manometry were evaluated before and 3 months after surgery .
METHODS	Anatomical success was defined as POP-Q Stage II or less .
METHODS	A t-test was used to compare preoperative with postoperative data in the two groups .
RESULTS	Totally , 17 ( 71 % ) were available for the follow-up .
RESULTS	POP-Q measurements improved significantly compared to baseline ( P < 0.05 ) in both groups .
RESULTS	No recurrence was observed .
RESULTS	Subjects in both groups reported improvement in pelvic floor symptoms , and there was no significant difference in the PFIQ-7 score between groups at follow-up ( P > 0.05 ) .
RESULTS	Compared with baseline , the nonmesh group exhibited a statistically significant decrease in anal residual pressure , a significant increase in the anorectal pressure difference during bowel movement , and a reduced rate of dyssynergia defecation pattern ( P < 0.05 ) .
CONCLUSIONS	Provided there is sufficient support for the anterior wall and apex of vagina with mesh , posterior compartment repair without mesh may be as effective as repair with mesh for anatomical recovery while providing better anorectal motor function .

###25604762
BACKGROUND	Long-lasting insecticide-treated net ( LLIN ) window and door curtains alone or in combination with LLIN water container covers were analysed regarding effectiveness in reducing dengue vector density , and feasibility of the intervention .
METHODS	A cluster randomised trial was conducted in an urban area of Colombia comparing 10 randomly selected control and 10 intervention clusters .
METHODS	In control clusters , routine vector control activities were performed .
METHODS	The intervention delivered first , LLIN curtains ( from July to August 2013 ) and secondly , water container covers ( from October to March 2014 ) .
METHODS	Cross-sectional entomological surveys were carried out at baseline ( February 2013 to June 2013 ) , 9 weeks after the first intervention ( August to October 2013 ) , and 4-6 weeks after the second intervention ( March to April 2014 ) .
RESULTS	Curtains were installed in 922 households and water container covers in 303 households .
RESULTS	The Breteau index ( BI ) fell from 14 to 6 in the intervention group and from 8 to 5 in the control group .
RESULTS	The additional intervention with LLIN covers for water containers showed a significant reduction in pupae per person index ( PPI ) ( p = 0.01 ) .
RESULTS	In the intervention group , the PPI index showed a clear decline of 71 % compared with 25 % in the control group .
RESULTS	Costs were high but options for cost savings were identified .
CONCLUSIONS	Short term impact evaluation indicates that the intervention package can reduce dengue vector density but sustained effect will depend on multiple factors .

###25650964
OBJECTIVE	There is no consensus as to which bariatric procedure is preferred to reduce weight and improve health in patients with a body mass index higher than 50 .
OBJECTIVE	To compare 5-year outcomes after Roux-en-Y gastric bypass ( gastric bypass ) and biliopancreatic diversion with duodenal switch ( duodenal switch ) .
METHODS	Randomized clinical open-label trial at Oslo University Hospital , Oslo , Norway , and Sahlgrenska University Hospital , Gothenburg , Sweden .
METHODS	Participants were recruited between March 17 , 2006 , and August 20 , 2007 , and included 60 patients aged 20 to 50 years with a body mass index of 50 to 60 .
METHODS	The current study provides the 5-year follow-up analyses by intent to treat , excluding one participant accepted for inclusion who declined being operated on prior to knowing to what group he was randomized .
METHODS	Laparoscopic gastric bypass and laparoscopic duodenal switch .
METHODS	Body mass index and secondary outcomes including anthropometric measures , cardiometabolic risk factors , pulmonary function , vitamin status , gastrointestinal symptoms , health-related quality of life , and adverse events .
RESULTS	Sixty patients were randomly assigned and operated on with gastric bypass ( n = 31 ) and duodenal switch ( n = 29 ) .
RESULTS	Fifty-five patients ( 92 % ) completed the study .
RESULTS	Five years after surgery , the mean reductions in body mass index were 13.6 ( 95 % CI , 11.0-16 .1 ) and 22.1 ( 95 % CI , 19.5-24 .7 ) after gastric bypass and duodenal switch , respectively .
RESULTS	The mean between-group difference was 8.5 ( 95 % CI , 4.9-12 .2 ; P < .001 ) .
RESULTS	Remission rates of type 2 diabetes mellitus and metabolic syndrome and changes in blood pressure and lung function were similar between groups .
RESULTS	Reductions in total cholesterol , low-density lipoprotein cholesterol , triglycerides , and fasting glucose were significantly greater after duodenal switch compared with gastric bypass .
RESULTS	Serum concentrations of vitamin A and 25-hydroxyvitamin D were significantly reduced after duodenal switch compared with gastric bypass .
RESULTS	Duodenal switch was associated with more gastrointestinal adverse effects .
RESULTS	Health-related quality of life was similar between groups .
RESULTS	Patients with duodenal switch underwent more surgical procedures related to the initial procedure ( 13 [ 44.8 % ] vs 3 [ 9.7 % ] patients ; P = .002 ) and had significantly more hospital admissions compared with patients with gastric bypass .
CONCLUSIONS	In patients with a body mass index of 50 to 60 , duodenal switch resulted in greater weight loss and greater improvements in low-density lipoprotein cholesterol , triglyceride , and glucose levels 5 years after surgery compared with gastric bypass while improvements in health-related quality of life were similar .
CONCLUSIONS	However , duodenal switch was associated with more surgical , nutritional , and gastrointestinal adverse effects .
BACKGROUND	clinicaltrials.gov Identifier : NCT00327912 .

###24977631
BACKGROUND	We present the results of a previously unpublished hemoglobin-based oxygen carrier ( HBOC ) study conducted in 1998-1999 .
METHODS	In a multicenter , randomized , single-blind , comparative study of HBOC-201 versus allogeneic red blood cell ( RBC ) transfusions , no-cardiac surgery patients received HBOC-201 to a maximum of 7 units ( n = 83 ) or RBCs ( n = 77 ) .
METHODS	Patients could be switched to RBCs for safety or any other reason .
METHODS	The efficacy end points were elimination and/or reduction of allogeneic RBC transfusions for 28 days .
RESULTS	The proportion of patients in the HBOC-201 group that avoided RBC transfusion was 0.427 ( 95 % confidence interval , 0.321-0 .533 ) .
RESULTS	Subjects in the HBOC-201 group received on average 3.2 units of RBCs versus 4.4 units in the control arm ( P = 0.004 ) .
RESULTS	Seventy-nine ( 95.2 % ) subjects in the HBOC-201 group and 72 ( 93.5 % ) in the RBC group experienced adverse events ( AEs ) , judged to be associated with study treatment in 59 ( 71.1 % ) and 18 ( 23.4 % ) subjects , respectively .
RESULTS	Thirty-day mortality , 5 ( 6.0 % ) vs 4 ( 5.2 % ) patients ( P = 1.00 ) , incidence of serious AEs , 24 ( 28.9 % ) vs 20 ( 26.0 % ) ( P = 0.73 ) , or time to intensive care unit ( log-rank P = 0.15 ) or hospital discharge ( log-rank P = 0.53 ) were similar for the HBOC-201 and RBC groups , respectively .
CONCLUSIONS	Up to 7 units of HBOC-201 infused over the course of 6 days resulted in RBC transfusion avoidance in 43 % of patients .
CONCLUSIONS	There were no notable differences in mortality and serious AEs incidence .
CONCLUSIONS	The use of HBOC-201 was associated with a notable excess of nonserious AEs .

###24368463
OBJECTIVE	Early , safe , effective , and durable evidence-based interventions for children and adolescents with chronic migraine do not exist .
OBJECTIVE	To determine the benefits of cognitive behavioral therapy ( CBT ) when combined with amitriptyline vs headache education plus amitriptyline .
METHODS	A randomized clinical trial of 135 youth ( 79 % female ) aged 10 to 17 years diagnosed with chronic migraine ( 15 days with headache/month ) and a Pediatric Migraine Disability Assessment Score ( PedMIDAS ) greater than 20 points were assigned to the CBT plus amitriptyline group ( n = 64 ) or the headache education plus amitriptyline group ( n = 71 ) .
METHODS	The study was conducted in the Headache Center at Cincinnati Children 's Hospital between October 2006 and September 2012 ; 129 completed 20-week follow-up and 124 completed 12-month follow-up .
METHODS	Ten CBT vs 10 headache education sessions involving equivalent time and therapist attention .
METHODS	Each group received 1 mg/kg/d of amitriptyline and a 20-week end point visit .
METHODS	In addition , follow-up visits were conducted at 3 , 6 , 9 , and 12 months .
METHODS	The primary end point was days with headache and the secondary end point was PedMIDAS ( disability score range : 0-240 points ; 0-10 for little to none , 11-30 for mild , 31-50 for moderate , > 50 for severe ) ; both end points were determined at 20 weeks .
METHODS	Durability was examined over the 12-month follow-up period .
METHODS	Clinical significance was measured by a 50 % or greater reduction in days with headache and a disability score in the mild to none range ( < 20 points ) .
RESULTS	At baseline , there were a mean ( SD ) of 21 ( 5 ) days with headache per 28 days and the mean ( SD ) PedMIDAS was 68 ( 32 ) points .
RESULTS	At the 20-week end point , days with headache were reduced by 11.5 for the CBT plus amitriptyline group vs 6.8 for the headache education plus amitriptyline group ( difference , 4.7 [ 95 % CI , 1.7-7 .7 ] days ; P = .002 ) .
RESULTS	The PedMIDAS decreased by 52.7 points for the CBT group vs 38.6 points for the headache education group ( difference , 14.1 [ 95 % CI , 3.3-24 .9 ] points ; P = .01 ) .
RESULTS	In the CBT group , 66 % had a 50 % or greater reduction in headache days vs 36 % in the headache education group ( odds ratio , 3.5 [ 95 % CI , 1.7-7 .2 ] ; P < .001 ) .
RESULTS	At 12-month follow-up , 86 % of the CBT group had a 50 % or greater reduction in headache days vs 69 % of the headache education group ; 88 % of the CBT group had a PedMIDAS of less than 20 points vs 76 % of the headache education group .
RESULTS	Measured treatment credibility and integrity was high for both groups .
CONCLUSIONS	Among young persons with chronic migraine , the use of CBT plus amitriptyline resulted in greater reductions in days with headache and migraine-related disability compared with use of headache education plus amitriptyline .
CONCLUSIONS	These findings support the efficacy of CBT in the treatment of chronic migraine in children and adolescents .
BACKGROUND	clinicaltrials.gov Identifier : NCT00389038 .

###24674974
OBJECTIVE	Interventions targeting sedentary time are needed .
OBJECTIVE	We used detailed EMG recordings to study the short-term effectiveness of simple sedentary time-targeted tailored counseling on the total physical activity spectrum .
METHODS	This cluster randomized controlled trial was conducted between 2011 and 2013 ( InPact , ISRCTN28668090 ) , and short-term effectiveness of counseling is reported in the present study .
METHODS	A total of 133 office workers volunteered to participate , from which muscle activity data were analyzed from 48 ( intervention , n = 24 ; control , n = 24 ) .
METHODS	After a lecture , face-to-face tailored counseling was used to set contractually binding goals regarding breaking up sitting periods and increasing family based physical activity .
METHODS	Primary outcome measures were assessed 11.8 1.1 h before and a maximum of 2 wk after counseling including quadriceps and hamstring muscle inactivity time , sum of the five longest muscle inactivity periods , and light muscle activity time during work , commute , and leisure time .
RESULTS	Compared with those in the controls , counseling decreased the intervention group 's muscle inactivity time by 32.6 71.8 min from 69.1 % 8.5 % to 64.6 % 10.9 % ( whole day , P < 0.05 ; work , P < 0.05 ; leisure , P < 0.05 ) and the sum of the five longest inactivity periods from 35.6 14.8 to 29.7 10.1 min ( whole day , P < 0.05 ; leisure , P < 0.01 ) .
RESULTS	Concomitantly , light muscle activity time increased by 20.6 52.6 min , from 22.2 % 7.9 % to 25.0 % 9.7 % ( whole day , P < 0.05 ; work , P < 0.01 ; leisure , P < 0.05 ) , and during work time , average EMG amplitude ( percentage of EMG during maximal voluntary isometric contraction ( MVC ) ( % EMG MVC ) ) increased from 1.6 % 0.9 % to 1.8 % 1.0 % ( P < 0.05 ) in the intervention group compared with that in the controls .
CONCLUSIONS	A simple tailored counseling was able to reduce muscle inactivity time by 33 min , which was reallocated to 21 min of light muscle activity .
CONCLUSIONS	During work time , average EMG amplitude increased by 13 % , reaching an average of 1.8 % of EMG MVC .
CONCLUSIONS	If maintained , this observed short-term effect may have health-benefiting consequences .

###24681850
OBJECTIVE	To compare the diagnostic performance of adaptive statistical iterative reconstruction applied low-dose computed tomography ( CT ) ( LDCT ) with that of the standard-dose CT ( SDCT ) for local recurrence in patients with stomach cancer .
METHODS	Seventy-nine consecutive patients who had undergone surgical resection for stomach cancer were enrolled .
METHODS	To monitor recurrence , SDCT ( 120 kilovolt peak [ kVp ] , 200mAs ) had been performed .
METHODS	The LDCT ( 120 kVp , 100 mA s ) was taken , and images were reconstructed with 4 levels of adaptive statistical iterative reconstruction ( ASIR ) blending ( 0 % , 30 % , 50 % , and 70 % ) .
METHODS	Two blinded radiologists recorded the diagnostic confidence scores for local recurrence in each data set using a 5-point scale .
METHODS	Endoscopic biopsy results served as the reference standard .
METHODS	Receiver operating characteristic ( ROC ) curve analysis was used to calculate the diagnostic performance .
RESULTS	The diagnostic performance of LDCT with variable ASIR blending ratios was comparable to that of SDCT ( area under ROC curve , 0.727-0 .734 , 0.687 , respectively , P > 0.05 ) .
CONCLUSIONS	The diagnostic performance of ASIR applied LDCT is comparable to that of SDCT .

###24703091
OBJECTIVE	To evaluate and compare the shear bond strength ( SBS ) of stainless steel and gold-plated attachments to impacted lower third molars in vivo and in vitro with a light-cured orthodontic resin .
METHODS	Sixteen patients with bilaterally full soft tissue impaction of lower third molars were recruited on a voluntary basis from an oral and maxillofacial surgery department .
METHODS	A split-arch technique was used .
METHODS	Following surgical exposure of the crown , the tooth was luxated but not extracted .
METHODS	Then , two attachments ( one stainless steel button and one gold-plated eyelet ) were bonded to the labial enamel surface of the loosened tooth .
METHODS	Five minutes later , the luxated tooth was removed from its socket .
METHODS	In each patient , the impacted tooth on the other side was extracted , and attachments were bonded in vitro .
METHODS	The SBSs of the attachments were evaluated .
METHODS	For comparison , analysis of variance and multiple range tests were used ( = 0.05 ) .
RESULTS	Statistically significant differences were evident in attachment adhesion to the impacted tooth surfaces among the four groups ( p < 0.001 ) .
RESULTS	Superior SBS values were obtained for stainless steel button groups bonded in vitro .
RESULTS	The mean bond strengths of the groups bonded in vitro were better than those of the same groups bonded in vivo .
CONCLUSIONS	Although the in vitro-bonded groups showed higher SBS values , adequate bond strength is possible with stainless steel buttons bonded in vivo .

###24838809
OBJECTIVE	The current study evaluated the costs and benefits of a simple aerobic walking program for patients with chronic obstructive pulmonary disease ( COPD ) .
METHODS	This was a blinded randomized controlled clinical trial that recruited 72 patients diagnosed with COPD , 40 of whom were included in the study and divided into two groups [ control group ( CG ) and pulmonary rehabilitation group ( GPR ) ] .
METHODS	We assessed pulmonary function , distance covered during the 6-minute walk test ( 6MWT ) , respiratory and peripheral muscle strength , health-related quality of life ( HRQOL ) , body composition , and level of activities of daily living ( ADLs ) before and after an 8-week walking program .
METHODS	The financial costs were calculated according to the pricing table of the Brazilian Unified Health System ( SUS ) .
RESULTS	Only 34 of the 40 patients remained in the final sample ; 16 in the CG and 18 in the GPR ( FEV1 : 50.9 14 % predicted and FEV1 : 56 0.5 % predicted , respectively ) .
RESULTS	The intervention group exhibited improvements in the 6MWT , sensation of dyspnea and fatigue , work performed , BODE index ( p < 0.01 ) , HRQOL , ADL level ( p < 0.001 ) , and lower limb strength ( p < 0.05 ) .
RESULTS	The final mean cost per patient for the GPR was R$ 148.75 ( ~ US$ 75.00 ) and no patient significantly exceeded this value .
RESULTS	However , 2 patients in the CG did exceed this value , incurring a cost of R$ 689.15 ( ~ US$ 345.00 ) .
CONCLUSIONS	Aerobic walking demonstrated significant clinical benefits in a cost-efficient manner in patients with COPD .

###25936814
OBJECTIVE	The purpose of this study was to conduct a randomized trial of radiation therapy for plantar fasciitis and to compare radiation therapy with local steroid injections .
METHODS	Between March 2013 and April 2014 , 128 patients with plantar fasciitis were randomized to receive radiation therapy ( total dose of 6.0 Gy applied in 6 fractions of 1.0 Gy three times a week ) or local corticosteroid injections a 1 ml injection of 40 mg methylprednisolone and 0.5 ml 1 % lidocaine under the guidance of palpation .
METHODS	The results were measured using a visual analog scale , a modified von Pannewitz scale , and a 5-level function score .
METHODS	The fundamental phase of the study was 3 months , with a follow-up period of up to 6 months .
RESULTS	The median follow-up period for all patients was 12.5 months ( range , 6.5-18 .6 months ) .
RESULTS	For the radiation therapy patients , the median follow-up period was 13 months ( range , 6.5-18 .5 months ) , whereas in the palpation-guided ( PG ) steroid injection arm , it was 12.1 months ( range , 6.5-18 .6 months ) .
RESULTS	After 3 months , results in the radiation therapy arm were significantly superior to those in the PG steroid injection arm ( visual analog scale , P < .001 ; modified von Pannewitz scale , P < .001 ; 5-level function score , P < .001 ) .
RESULTS	Requirements for a second treatment did not significantly differ between the 2 groups , but the time interval for the second treatment was significantly shorter in the PG steroid injection group ( P = .045 ) .
CONCLUSIONS	This study confirms the superior analgesic effect of radiation therapy compared to mean PG steroid injection on plantar fasciitis for at least 6 months after treatment .

###24864063
BACKGROUND	Dispatcher-assisted CPR ( DA-CPR ) can increase rates of bystander CPR , survival , and quality of life following cardiac arrest .
BACKGROUND	Dispatcher protocols designed to improve rapid recognition of arrest and coach CPR may increase survival by ( 1 ) reducing preventable time delays to start of chest compressions and ( 2 ) improving the quality of bystander CPR .
METHODS	We conducted a randomized controlled trial comparing a simplified DA CPR script to a conventional DA CPR script in a manikin cardiac arrest simulation with lay participants .
METHODS	The primary outcomes measured were the time interval from call receipt to the first chest compression and the core metrics of chest compression ( depth , rate , release , and compression fraction ) .
METHODS	CPR was measured using a recording manikin for the first 3 min of participant CPR .
RESULTS	Of the 75 participants , 39 were randomized to the simplified instructions and 36 were randomized to the conventional instructions .
RESULTS	The interval from call receipt to first compression was 99 s using the simplified script and 124 s using the conventional script for a difference of 24s ( p < 0.01 ) .
RESULTS	Although hand position was judged to be correct more often in the conventional instruction group ( 88 % versus 63 % , p < 0.01 ) , compression depth was an average 7 mm deeper among those receiving the simplified CPR script ( 32 mm versus 25 mm , p < 0.05 ) .
RESULTS	No statistically significant differences were detected between the two instruction groups for compression rate , complete release , number of hands-off periods , or compression fraction .
CONCLUSIONS	Simplified DA-CPR instructions to lay callers in simulated cardiac arrest settings resulted in significant reductions in time to first compression and improvements in compression depth .
CONCLUSIONS	These results suggest an important opportunity to improve DA CPR instructions to reduce delays and improve CPR quality .

###24762110
BACKGROUND	Calcium intake during growth is essential for future bone health but varies widely between individuals and populations .
BACKGROUND	The impact on bone of increasing calcium intake is unknown in a population where low calcium intake , stunting , and delayed puberty are common .
OBJECTIVE	To determine the effect of prepubertal calcium supplementation on mean age at peak velocity for bone growth and mineral accrual .
METHODS	Prospective follow-up of boys in rural Gambia , West Africa , who had participated in a double-blind , randomized , placebo-controlled trial of calcium supplementation .
METHODS	Eighty boys , initially aged 8.0-11 .9 years , were followed up for 12 years .
METHODS	Subjects received 1 year of calcium carbonate supplementation ( 1000 mg daily , 5 d/wk ) .
METHODS	Dual-energy x-ray absorptiometry measurements were carried out for whole body ( WB ) , lumbar spine , and total hip bone mineral content , bone area ( BA ) , and WB lean mass .
METHODS	Super imposition by translation and rotation models was made to assess bone growth .
RESULTS	Age at peak velocity was consistently earlier in the calcium group compared to the placebo group , for WB bone mineral content ( mean , -6.2 [ SE , 3.1 ] ; P = .05 ) , WB BA ( mean , -7.0 [ SE , 3.2 ] mo ; P = .03 ) , lumbar spine and total hip BA .
RESULTS	By young adulthood , supplementation did not change the amount of bone accrued ( mineral or size ) or the rate of bone growth .
CONCLUSIONS	Twelve months of prepubertal calcium carbonate supplementation in boys with a low calcium diet advanced the adolescent growth spurt but had no lasting effect on bone mineral or bone size .
CONCLUSIONS	There is a need for caution when applying international recommendations to different populations .

###24849441
OBJECTIVE	To evaluate the long-term clinical outcomes of fractional flow reserve ( FFR ) - guided versus intravascular ultrasound ( IVUS ) - guided percutaneous coronary intervention ( PCI ) for intermediate coronary lesions .
METHODS	A total of 226 patients with 293 intermediate coronary artery lesions ( stenosis of 40 % -70 % ) confirmed by coronary angiography were randomized into 3 groups to undergo PCI for a minimal lumen cross sectional area ( MLA ) < 4 mm ( 2 ) ( IVUS group , 98 lesions ) or for a FFR < 0.80 ( FFR group , 101 lesions ) , or to receive standard medical treatment ( medication group , 94 lesions ) .
METHODS	The primary outcome was major adverse cardiac events including death , myocardial infarction , and ischemia-driven target vessel revascularization at 1 year after the index procedure .
RESULTS	The baseline percent diameter stenosis and lesion length were similar between the 3 groups , but more patients in IVUS group than in FFR group received PCI ( P < 0.001 ) .
RESULTS	No significant difference was found in the incidence of major adverse cardiac events between the 3 groups ( P = 0.182 ) .
CONCLUSIONS	Both FFR - and IVUS-guided PCI strategy for intermediate coronary artery disease are associated with favorable outcomes , but IVUS-guided PCI based on the single index of MLA can increase the rate of revascularization therapy .

###25671931
BACKGROUND	Thalassemia major is the most common genetic disorder in Pakistan .
BACKGROUND	The study was done to compare the efficacy and safety of the deferiprone with deferrioxamine for the treatment of iron overload in children with thalassemia major .
METHODS	This randomized controlled trail was conducted at thalassemia blood transfusion unit of Allied Hospital , Faisalabad ( AHF ) / District Headquarter Hospital ( DHQ ) , Faisalabad .
METHODS	Thalassemia-Unit Hilal-e-Ahmar , Alizeb Foundation and Blood Bank Services Faisalabad from November 2010 to December 2011 .
METHODS	Children with beta thalassemia major of age more than 2 years and less than 16 years with transfusion iron over load were randomly allocated to one of the two groups each comprising of 67 patients .
METHODS	One group received deferiprone given at a daily dose of 75mg/kg in three divided doses orally while the other group received deferrioxamine at dose 50 mg/kg/24hrs for 5 days/week as parental infusion .
METHODS	Changes in the serum ferritin level were assessed .
METHODS	Cardiac function and toxicity were also examined .
RESULTS	Serum ferritin was significantly reduced after 1 year in both treatment arms ( p = 0.01 ) .
RESULTS	Neutropenia observed in 13 ( 19.40 % ) non-splenectomized patients taking deferiprone .
RESULTS	Transient elevations in ALT were observed in 3 ( 4.47 % ) children taking deferiprone .
RESULTS	Left ventricular ejection fraction ( LVEF ) remained in normal range in both treatment arm but has decreased significantly in Deferrioxamine group compliance .
RESULTS	Compliance was better in deferiprone as compared to deferrioxamine .
RESULTS	Discontinuing percentage 2 ( 3 % ) vs 9 ( 13.43 % ) .
CONCLUSIONS	Deferiprone is a highly efficacious and safe chelation therapy for patients with thalassemia major who are non-compliant to Deferrioxamine .
CONCLUSIONS	Deferiprone have an efficacy profile comparable to standard Deferrioxamine .

###24849193
OBJECTIVE	The objective of the present study was to develop population pharmacokinetic models for olmesartan medoxomil and hydrochlorothiazide and to investigate the influence of demographic factors on these population pharmacokinetics .
METHODS	Plasma concentrations of olmesartan medoxomil and hydrochlorothiazide were measured in 41 healthy volunteers enrolled in our bioequivalence study by LC-MS/MS following oral administration of an olmesartan medoxomil/hydrochlorothiazide ( 20/12 .5 mg ) fixed-dose combination tablet .
METHODS	This data and covariates were subjected to nonlinear mixed-effect modeling analysis using the NONMEM software .
METHODS	Evaluation featured a visual predicted check and bootstrapping .
RESULTS	The distributions of olmesartan medoxomil and hydrochlorothiazide were best fitted using a two-compartment model with no lag time and first-order elimination .
RESULTS	When analyzing hydrochlorothiazide kinetics , we found that TCHO and CL/F were correlated , while .
RESULTS	HB and Ka influenced olmesartan medoxomil modeling .
RESULTS	All evaluations indicated that the pharmacokinetic profiles of olmesartan medoxomil and hydrochlorothiazide were adequately described using our PPK model .
CONCLUSIONS	This study indicates that demographic factors influence the inter-individual variability in the disposition of the combination drug , and it might be more useful to apply it to the PK of olmesartan medoxomil/hydrochlorothiazide ( 20/12 .5 mg ) FDC tablets administered to patients with hypertension .
CONCLUSIONS	* These two authors contributed equally to this work .

###24495855
BACKGROUND	Physician-coded verbal autopsy ( PCVA ) is the most widely used method to determine causes of death ( CODs ) in countries where medical certification of death is uncommon .
BACKGROUND	Computer-coded verbal autopsy ( CCVA ) methods have been proposed as a faster and cheaper alternative to PCVA , though they have not been widely compared to PCVA or to each other .
METHODS	We compared the performance of open-source random forest , open-source tariff method , InterVA-4 , and the King-Lu method to PCVA on five datasets comprising over 24,000 verbal autopsies from low - and middle-income countries .
METHODS	Metrics to assess performance were positive predictive value and partial chance-corrected concordance at the individual level , and cause-specific mortality fraction accuracy and cause-specific mortality fraction error at the population level .
RESULTS	The positive predictive value for the most probable COD predicted by the four CCVA methods averaged about 43 % to 44 % across the datasets .
RESULTS	The average positive predictive value improved for the top three most probable CODs , with greater improvements for open-source random forest ( 69 % ) and open-source tariff method ( 68 % ) than for InterVA-4 ( 62 % ) .
RESULTS	The average partial chance-corrected concordance for the most probable COD predicted by the open-source random forest , open-source tariff method and InterVA-4 were 41 % , 40 % and 41 % , respectively , with better results for the top three most probable CODs .
RESULTS	Performance generally improved with larger datasets .
RESULTS	At the population level , the King-Lu method had the highest average cause-specific mortality fraction accuracy across all five datasets ( 91 % ) , followed by InterVA-4 ( 72 % across three datasets ) , open-source random forest ( 71 % ) and open-source tariff method ( 54 % ) .
CONCLUSIONS	On an individual level , no single method was able to replicate the physician assignment of COD more than about half the time .
CONCLUSIONS	At the population level , the King-Lu method was the best method to estimate cause-specific mortality fractions , though it does not assign individual CODs .
CONCLUSIONS	Future testing should focus on combining different computer-coded verbal autopsy tools , paired with PCVA strengths .
CONCLUSIONS	This includes using open-source tools applied to larger and varied datasets ( especially those including a random sample of deaths drawn from the population ) , so as to establish the performance for age - and sex-specific CODs .

###24579923
BACKGROUND	The cause of infertility is unexplained or poorly explained in 30-40 % of couples undergoing standard investigations , and treatment ranges from expectant management to IUI and IVF .
OBJECTIVE	The aim of this study was to compare the clinical pregnancy rates and costs of intra-uterine insemination ( IUI ) and in vitro fertilisation ( IVF ) in women where the same ovarian stimulation led to the development of two or three mature follicles .
METHODS	A randomised controlled clinical trial compared the efficacy of IUI and IVF in a tertiary fertility centre ( ISRCTN28780587 ) .
METHODS	Primary outcome measures were fetal heart positive pregnancy rate and cost per live birth .
METHODS	The selection criteria were age : females 18-42years and males 18-60years , infertility for one year or more , no IVF or IUI for 12months prior to the trial , and no coital , tubal or ovulatory disorders , oligospermia , untreated endometriosis or contraindication for multiple pregnancy .
METHODS	All women ( n = 102 ) had the same dose FSH stimulation protocol .
METHODS	Those who developed two or three preovulatory follicles were randomised 3:1 to IUI ( n = 33 ) or IVF ( n = 10 ) .
METHODS	IUI or IVF was performed 36h after hCG administration with single or double embryo transfer on day two .
RESULTS	Clinical pregnancy rates ( 40 % vs 12 % , P = 0.04 ) and live birth rate ( 40 % vs 6 % , P = 0.01 ) were higher for IVF than IUI .
RESULTS	The cost per live birth was AU$ 8735 for IVF compared with $ 42,487 for IUI .
CONCLUSIONS	This study provides evidence that IVF is more successful and cost-effective than IUI using the same doses of FSH .
CONCLUSIONS	Further confirmatory studies are required .

###25223728
BACKGROUND	Given verapamil 's property as a glycoprotein inhibitor , this drug could increase the effective concentration of antiepileptic drugs ( AEDs ) in the epileptic foci , reducing the number of seizures .
BACKGROUND	This pilot study was designed to evaluate the safety and efficacy of verapamil as adjunct therapy in pharmacoresistant patients with focal onset seizures .
METHODS	This was a single-centered , randomized , double-blind and placebo-controlled trial evaluating verapamil as an add-on therapy for adult patients with refractory epilepsy .
RESULTS	Twenty-two patients were randomized , but five of them withdrew and one patient passed away after consent , having no exposure to either verapamil or placebo ; four patients withdrew during or after the double-blind phase due to side effects .
RESULTS	From these four patients , only one patient was in the verapamil group .
RESULTS	Twelve patients ( 59 % ) finished the study .
RESULTS	Some patients experienced lower seizure frequencies , but none of them reached 50 % reduction .
RESULTS	In addition , there was no statistically significant decrease in the seizure frequency of patients receiving verapamil .
RESULTS	When comparing the verapamil with the placebo at the double-blind or the open label study phases , the average difference in seizure range also failed to show significance ( p = 0.41 and p = 0.98 , respectively ) .
RESULTS	No significant cardiovascular effects were observed , and side effects unique to verapamil were skin rashes and feet edema .
RESULTS	Throughout the study , carbamazepine , valproic acid and clobazam levels increased following verapamil intake ; minor dosage adjustment was required in one patient on carbamazepine .
CONCLUSIONS	This pilot study has shown mild benefits of verapamil use in comparison to placebo as an add-on therapy for a group of non-selected patients with refractory epilepsy .
CONCLUSIONS	A partial response in a subset of patients was seen .
CONCLUSIONS	No significant safety problems happened , but adjustments on AEDs may be required during verapamil use .

###25002006
BACKGROUND	Depression has been widely studied in primary care settings , yet studies of medically uninsured populations are lacking .
BACKGROUND	We sought to determine whether depression screening and treatment improved depression scores of a medically uninsured , mostly African American primary care population .
METHODS	The study was a prospective repeated-measures design that recruited uninsured patients .
METHODS	Patients were screened for depression , and the rate of depression diagnosis was compared with baseline .
METHODS	Patients who were diagnosed and accepted treatment were randomized to 1 of 4 treatment arms : ( 1 ) usual care ; ( 2 ) usual care and psychotherapy ; ( 3 ) usual care and education and psychotherapy ; and ( 4 ) usual care and education .
METHODS	Patients were then reevaluated at 8 , 12 , and 24 weeks .
RESULTS	A total of 674 patients participated .
RESULTS	Depression prevalence was significantly higher among those screened ( 38 % ) than at baseline ( 16 % ) .
RESULTS	All treatment groups showed a significant reduction in depression scores over a 6-month period , from a mean score of 15 at baseline to 8.3 at 24 weeks ( P < .005 ) .
RESULTS	All treatment interventions were equally effective .
CONCLUSIONS	Screening improves the rate of diagnosis of depression in an uninsured , primarily African American population , and subsequent treatment significantly reduces the burden of depression .

###26314530
BACKGROUND	In patients with resistant hypertension ( RH ) and obstructive sleep apnea ( OSA ) , the blood pressure response to continuous positive airway pressure ( CPAP ) treatment is highly variable and could be associated with differential micro-ribonucleic acid ( miRNA ) profiles .
BACKGROUND	Currently , no available methods exist to identify patients who will respond favorably to CPAP treatment .
OBJECTIVE	The aim of this study was to identify plasma miRNA profiles that predict blood pressure responses to CPAP treatment .
METHODS	Cardiovascular system-focused circulating miRNA expression was evaluated in plasma samples using an 84-miRNA array among patients with RH and OSA at baseline and after 3 months of adherent CPAP use .
METHODS	Pathway analysis and miRNA target gene enrichment were performed in silico .
METHODS	Plasma levels of peptides and hormones related to cardiovascular function were also measured .
RESULTS	The OSA responder group exhibited blood pressure decreases exceeding the observed median ( > 4.5 mm Hg ) after CPAP , which were not present in the nonresponder group ( 4.5 mm Hg ) ( p < 0.01 ) .
RESULTS	Three miRNAs provided a discriminatory predictive model for such a favorable blood pressure response to CPAP ( area under the curve : 0.92 ; p = 0.01 ) .
RESULTS	Additionally , CPAP treatment significantly altered a total of 47 plasma miRNAs and decreased aldosterone-to-renin ratios in the responder group ( p = 0.016 ) but not in the nonresponder group .
CONCLUSIONS	A singular pre-CPAP treatment cluster of 3 plasma miRNAs predicts blood pressure responses to CPAP treatment in patients with RH and OSA .
CONCLUSIONS	CPAP treatment is accompanied by changes in cardiovascular system-related miRNAs that may potentially influence the risk for cardiovascular disease among patients with OSA and RH .
CONCLUSIONS	( Effect of Continuous Positive Airway Pressure [ CPAP ] Treatment in the Control of Refractory Hypertension ; NCT00616265 ) .

###24803153
OBJECTIVE	To evaluate and compare the effects of single intravitreal injection of ranibizumab and bevacizumab on central retinal and choroidal thickness in patients with neovascular age-related macular degeneration ( AMD ) .
METHODS	Forty eyes of 40 patients with neovascular AMD that underwent intravitreal injection of vascular endothelial growth factor inhibitors ( anti-VEGFs ) were included .
METHODS	Patients were randomized into 2 groups : 20 eyes received ranibizumab and 20 eyes received bevacizumab injection .
METHODS	Central retinal and choroidal thicknesses of all eyes at baseline and 1 month postinjection scans were measured with Fourier-domain optical coherence tomography ( OCT ) .
METHODS	Student t test and Mann-Whitney U test were used to compare the data .
RESULTS	The mean central retinal thickness ( CRT ) showed significant decrease after single injection of ranibizumab ( from 345.0 m to 253.5 m , p < 0.01 ) and bevacizumab ( from 329.5 m to 251.0 m , p < 0.01 ) at the first month , respectively .
RESULTS	There was no significant difference regarding the CRT change between groups ( p = 0.39 ) .
RESULTS	The mean choroidal thickness decreased from 158.6 m ( 115-317 ) to 155.5 m ( 111-322 ) in the ranibizumab group and from 211.5 m ( 143-284 ) to 201.5 m ( 93-338 ) in bevacizumab group .
RESULTS	The decrease was not significant between groups ( p = 0.35 ) .
CONCLUSIONS	Intravitreal injection of both ranibizumab and bevacizumab provided a significant decrease in CRT ; however , the agents caused no significant change in choroidal thickness .
CONCLUSIONS	Additionally , no difference between ranibizumab versus bevacizumab was observed related to macular edema inhibition .

###24848384
OBJECTIVE	To evaluate the effect of intraoperative low-dose ketamine with general anesthesia on postoperative pain after total knee replacement surgery .
METHODS	A randomized , double-blind comparative study .
METHODS	Ankara Numune Training and Research Hospital , Turkey , from January and June 2011 .
METHODS	Sixty adults undergoing total knee arthroplasty were enrolled in this study .
METHODS	The patients were randomly allocated into two groups of equal size to receive either racemic ketamine infusion ( 6 g/kg/minute ) or the same volume of saline .
METHODS	A visual analogue scale ( VAS ) was used to measure each patient 's level of pain at 1 , 3 , 6 , 12 , and 24 hours after surgery .
METHODS	Time to first analgesic request , postoperative morphine consumption and the incidence of side effects were also recorded .
RESULTS	Low-dose ketamine infusion prolonged the time to first analgesic request .
RESULTS	It also reduced postoperative cumulative morphine consumption at 1 , 3 , 6 , 12 , and 24 hours postsurgery ( p < 0.001 ) .
RESULTS	Postoperative VAS scores were also significantly lower in the ketamine group than placebo , at all observation times .
RESULTS	Incidences of side effects were similar in both study groups .
CONCLUSIONS	Intraoperative continuous low-dose ketamine infusion reduced pain and postoperative analgesic consumption without affecting the incidence of side effects .

###24669829
BACKGROUND	AZD9164 has demonstrated potential as an inhaled , long-acting , muscarinic antagonist ( LAMA ) bronchodilator .
BACKGROUND	However , in patients with COPD , but not in healthy subjects , a transient initial drop in FEV1 was observed following inhalation of nebulised doses of AZD9164 in citrate buffer.Two additional studies were conducted to further assess the safety and tolerability of multiple ascending doses of AZD9164 in 27 white and 18 Japanese healthy subjects and in 4 patients with COPD .
BACKGROUND	In these studies , AZD9164 was inhaled via Turbuhaler .
METHODS	These were Phase I , randomised , double-blind , placebo-controlled , multiple ascending dose ( MAD ) studies conducted in Sweden and UK .
METHODS	Healthy subjects ( mean age 25.9 yrs ) and patients with COPD ( mean age 66 yrs , mean post-bronchodilator FEV1 60.1 % predicted normal value ) were randomised 2:1 to active treatment ( 400 , 1000 or 2800 g delivered doses of AZD9164 ) or placebo .
RESULTS	No safety or tolerability concerns were identified in the healthy subjects at doses up to and including 2800 g and both studies confirmed the bronchodilator effect of AZD9164 .
RESULTS	However , the first 3 patients in the COPD cohort who received AZD9164 ( 1000 g ) experienced a transient fall in FEV1 5 to 15 minutes after inhalation of AZD9164 while the patient receiving placebo did not .
RESULTS	The study safety review process then resulted in cessation of further activities on AZD9164 .
RESULTS	Retrospective analysis showed that two healthy subjects had also had transient falls in FEV1 shortly after inhalation of AZD9164 400 and 2800 g respectively , although neither reported any related respiratory symptoms or other AEs .
CONCLUSIONS	These results show that transient paradoxical bronchoconstriction can occur in some healthy subjects , in addition to patients with COPD , following inhalation of AZD9164 and that the citrate buffer used in the nebulised formulation can not have been the only cause of the drop in FEV1 in previous studies .
CONCLUSIONS	As preclinical data do not provide an explanation , the reasons for this brief post-dose drop in FEV1 remain unclear .
CONCLUSIONS	However , these results highlight the importance of monitoring lung function immediately post-dose when investigating novel inhaled treatments , even when a rapid onset of effect is not expected .
BACKGROUND	Clinicaltrials.gov NCT01016951 and NCT01096563 .

###24344872
BACKGROUND	Testosterone ( T ) administration to men increases T , estradiol ( E2 ) , dihydrotestosterone ( DHT ) , and fat-free mass ( FFM ) , and decreases fat mass ( FM ) but does not consistently improve insulin sensitivity ( IS ) .
OBJECTIVE	The aim of this study was to examine the effects of T administration in obese , nondiabetic men on body composition and IS , and to determine if inhibition ( i ) of metabolism of T to E2 with anastrazole or to DHT with dutasteride alters these effects .
METHODS	This was a 98-day randomized , double-blind , parallel group , placebo-controlled trial of 57 men , 24-51 year , free T in the lower 25 % of normal range ( < 0.33 nmol/L ) , body mass index 30.0 kg/m ( 2 ) .
METHODS	Subjects were randomized to one of four groups : ( i ) placebo : gel , pills , and injection ; ( ii ) T/DHT/iE2 : T gel , anastrazole , and acyline ( gonadotropin releasing-hormone antagonist to suppress endogenous T ) ; ( iii ) T/iDHT/E2 : T gel , dutasteride , and acyline ; ( iv ) T/DHT/E2 : T gel , placebo pills , and acyline .
METHODS	Main outcome measures are insulin sensitivity as percent change ( % ) in glucose disposal rates ( GDR ) from a two-step euglycemic clamp ( GDR1 and 2 ) , and % FM and % FFM by dual X-ray absorptiometry scan .
RESULTS	Insulin Sensitivity : % GDR1 differed across groups ( P = 0.02 , anova ) and was significantly higher in the dutasteride ( T/iDHT/E2 ) compared with the placebo and T gel ( T/DHT/E2 ) groups .
RESULTS	% GDR2 was higher in the dutasteride ( T/iDHT/E2 ) compared with the anastrazole ( T/DHT/iE2 ) group .
RESULTS	Body Composition : T gel alone ( T/DHT/E2 ) or with dutasteride ( T/iDHT/E2 ) significantly increased % FFM ( P < 0.05 ) and decreased % FM ( P < 0.05 ) .
RESULTS	There was no change in % FFM or % FM after placebo or anastrazole ( T/DHT/iE2 ) .
CONCLUSIONS	The combination of T plus dutasteride improved body composition and IS while T alone improved body composition but not IS , suggesting that when T is administered to men , reduction to DHT attenuates the beneficial effects of aromatization to E2 on IS but not body composition .

###24924304
OBJECTIVE	High-dose oestrogen treatment has been used to reduce growth in tall adolescent girls .
OBJECTIVE	The long-term safety with regard to cancer has not been clarified .
OBJECTIVE	Our aim was to study if this growth reduction therapy affects cancer risk later in life .
METHODS	A cohort study of 369 ( 172 treated , 197 untreated ) Swedish women who in 1973-1993 were assessed for tall adolescent stature was designed .
METHODS	Data were collected from university hospital records , patient questionnaires , and the Swedish Cancer Register .
RESULTS	Risks are presented as odds ratios ( ORs ) with 95 % confidence intervals comparing treated to untreated subjects .
RESULTS	In treated subjects , the overall OR for having a tumour ( malignant or non-malignant ) was 1.7 ( 0.8-3 .8 ) .
RESULTS	The ORs were 2.3 ( 0.4-12 .8 ) for breast tumours , 0.8 ( 0.2-2 .6 ) for gynaecological tumours , and 6.1 ( 1.04 - ) for melanoma .
RESULTS	When limiting to malignant tumours , the crude ORs were of similar magnitude .
CONCLUSIONS	The OR for any melanoma was higher in treated than in untreated women , suggesting an increased risk of melanoma associated with high-dose oestrogen treatment during adolescence .
CONCLUSIONS	Although the risk estimates were increased for overall tumours , breast tumours , malignant gynaecological tumours , and malignant melanoma , these associations were not statistically significant .
CONCLUSIONS	Our results need to be verified in a larger cohort .

###24807329
OBJECTIVE	To locate sites of genital tenderness in breast cancer survivors not using estrogen who experience dyspareunia and to test the hypothesis that tenderness is limited to the vulvar vestibule rather than the vagina and is reversed by topical anesthetic .
METHODS	Postmenopausal survivors of breast cancer with moderate and severe dyspareunia were recruited for an examination including randomization to a double-blind intervention using topical aqueous 4 % lidocaine or normal saline for 3 minutes to the areas found to be tender .
METHODS	Comparisons of changes in patients ' reported numerical rating scale values were made with the Wilcoxon rank-sum test with significance set at P < .05 .
RESULTS	Forty-nine patients aged 37-69 years ( mean 55.68.6 years ) had a median coital pain score of 8 ( interquartile range 7-9 , scale 0-10 ) .
RESULTS	On examination , all women had tenderness in the vulvar vestibule ( worst site 4 o'clock median 6 , 4-7 ) .
RESULTS	In addition , one had significant vaginal mucosal tenderness and two had pelvic floor myalgia .
RESULTS	All had vulvovaginal atrophy with 86 % having no intravaginal discharge .
RESULTS	Aqueous lidocaine 4 % reduced the vestibular tenderness of all painful sites .
RESULTS	For example , pain at the worst site changed from a median of 5 ( 4-7 ) to 0 ( 0-1 ) as compared with saline placebo , which changed the worst site score from 6 ( 4-7 ) to 4 ( 3-6 ) ( P < .001 ) .
RESULTS	After lidocaine application , speculum placement was nontender in the 47 without either myalgia or vaginal mucosal tenderness .
CONCLUSIONS	In breast cancer survivors with dyspareunia , exquisite sensitivity was vestibular and reversible with aqueous lidocaine .
CONCLUSIONS	Vaginal tenderness was rare despite severe atrophy .
BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT01539317 .
METHODS	I.

###25597699
BACKGROUND	Panax ginseng and Gingko biloba are commonly used herbal supplements in the United States that have been reported to increase alertness and cognitive function .
OBJECTIVE	The objective of this study was to investigate the effects of these specific herbals on driving performance .
METHODS	30 volunteers were tested using the STISIM3 Driving Simulator ( Systems Technology Inc. , Hawthorne , CA , USA ) in this double-blind , placebo-controlled study .
METHODS	The subjects were randomized into 3 groups of 10 subjects per group .
METHODS	After 10-min of simulated driving , subjects received either ginseng ( 1200 mg ) , Gingko ( 240 mg ) , or placebo administered orally .
METHODS	The test herbals and placebo were randomized and administered by a research assistant outside of the study to maintain blinding .
METHODS	One hour following administration of the herbals or placebo , the subjects completed an additional 10-min of simulated driving .
METHODS	Standard driving parameters were studied including reaction time , standard deviation of lateral positioning , and divided attention .
METHODS	Data collected for the divided attention parameter included time to response and number of correct responses .
METHODS	The data was analyzed with repeated-measures analysis of variance ( ANOVA ) and Kruskal-Wallis test using SPSS 22 ( IBM , Armonk , NY , USA ) .
RESULTS	There was no difference in reaction time or standard deviation of lateral positioning for both the ginseng and Ginkgo arms .
RESULTS	For the divided attention parameter , the response time in the Ginkgo arm decreased from 2.9 to 2.5 s.
RESULTS	The ginseng arm also decreased from 3.2 to 2.4 s. None of these values were statistically significant when between group differences were analyzed .
CONCLUSIONS	The data suggests there was no statistically significant difference between ginseng , Ginkgo or placebo on driving performance .
CONCLUSIONS	We postulate this is due to the relatively small numbers in our study .
CONCLUSIONS	Further study with a larger sample size may be needed in order to elucidate more fully the effects of Ginkgo and ginseng on driving ability .

###24599197
BACKGROUND	Patient-specific femoral and tibial cutting blocks produced with use of data from preoperative computed tomography ( CT ) or magnetic resonance imaging ( MRI ) scans have been employed recently to optimize component alignment in total knee arthroplasty .
BACKGROUND	We report the results of a randomized controlled trial in which CT scans were used to compare postoperative component alignment between patients treated with custom instruments and those managed with traditional instruments .
METHODS	The in-hospital data and early clinical outcomes , including Knee Society scores , were determined in a randomized clinical trial of forty-seven patients who had undergone a total of forty-eight primary total knee arthroplasties with patient-specific instruments ( twenty-two knees ) or standard instruments ( twenty-six knees ) .
METHODS	Orientation of the implants was compared by using three-dimensional CT data .
RESULTS	No significant differences were found between the study and control groups with respect to any clinical outcome after a minimum of six months of follow-up .
RESULTS	The patient-specific tibial cutting block was abandoned in favor of a standard external alignment jig in seven of the twenty-two study knees because of possible malalignment .
RESULTS	A detailed analysis of intent-to-treat and per-protocol groups of study and control knees did not show any significant improvement in component alignment , including femoral component rotation in the axial plane , in the patients treated with the custom instruments .
RESULTS	The percentage of outliers -- defined as less than -3 or more than 3 from the correct orientation of the tibial slope -- was significantly higher in the group treated with use of patient-specific blocks than it was in the control group , in both the intent-to-treat ( 32 % versus 8 % , p = 0.032 ) and the per-protocol ( 47 % versus 6 % , p = 0.0008 ) analysis .
CONCLUSIONS	There were no significant improvements in clinical outcomes or knee component alignment in patients treated with patient-specific cutting blocks as compared with those treated with standard instruments .
CONCLUSIONS	The group treated with patient-specific cutting blocks had a significantly higher prevalence of malalignment in terms of tibial component slope than the knees treated with standard instruments .

###24627207
BACKGROUND	The quantity of subarachnoid ( SAH ) and intraventricular hemorrhage ( IVH ) occurring in the setting of a ruptured cerebral aneurysm is strongly associated with subsequent complications and poor outcomes .
METHODS	We randomly allocated aneurysmal SAH patients with a modified Fisher score of 4 , who had been treated with endovascular coil embolization and ventricular drainage , to receive either 2 mg intraventricular tissue plasminogen activator ( TPA ) every 12 h ( maximum 10 mg ) or placebo .
METHODS	Computed tomography scans were performed 12 , 48 , and 72 h after administration .
METHODS	Primary outcomes included feasibility ( enrollment and consent rates ) , safety ( assessed by prospectively screening for complications ) , and rate of intracranial blood clearance ( measured using sequential IVH , modified Graeb , and SAH sum scores ) .
METHODS	Secondary outcomes included angiographic vasospasm , delayed cerebral ischemia , need for ventriculoperitoneal shunting , and 6-month neurological outcomes .
RESULTS	Seventy-seven patients were screened , 17 were eligible , and 12 were randomized .
RESULTS	The consent rate was 87 % .
RESULTS	There were no cases of new intracranial hemorrhage complicating use of TPA .
RESULTS	Models fit using generalized estimating equations demonstrated more rapid reduction in IVH volume ( p = 0.009 ) , modified Graeb score ( p < 0.001 ) , and SAH sum score ( p < 0.001 ) among patients treated with TPA .
RESULTS	SAH clearance at 48 h was enhanced by earlier drug administration ( p = 0.02 ) .
RESULTS	There were no differences in secondary outcomes .
CONCLUSIONS	Intraventricular TPA accelerates clearance of SAH and IVH , especially when administered early .
CONCLUSIONS	A larger-scale clinical trial of intraventricular TPA is feasible , will need to be conducted at multiple centers , and is required to determine whether this practice reduces complications and improves outcomes .

###24373063
OBJECTIVE	To compare a sulphonylurea with the glucagon like peptide-1 ( GLP-1 ) receptor agonist liraglutide in combination with metformin in patients on mono/dual oral therapy with established type 2 diabetes fasting during Ramadan .
METHODS	Ninety-nine adults intending to fast during Ramadan [ 50 % male , mean age 52years , body mass index ( BMI ) 32kg/m ( 2 ) ] were randomized from two UK sites .
METHODS	Baseline data were collected 14days prior to Ramadan and at 3 and 12weeks after Ramadan .
RESULTS	At 12weeks , more patients in the liraglutide compared with the sulphonylurea group achieved a composite endpoint of haemoglobin A1c ( HbA1c ) < 7 % , no weight gain and no severe hypoglycaemia but this did not reach statistical significance [ odds ratio ( OR ) 4.08 , 95 % confidence interval ( CI ) 0.97 , 17.22 , p = 0.06 ] .
RESULTS	From a baseline of 7.7 % there was no change in HbA1c at 12weeks in the sulphonylurea ( +0.02 % ) compared with a 0.3 % reduction in the liraglutide group ( adjusted coefficient -0.41 , 95 % CI -0.83 , 0.01 , p = 0.05 ) .
RESULTS	Significant reductions were also observed in weight and diastolic blood pressure ( BP ) in the liraglutide compared with the sulphonylurea group .
RESULTS	Treatment satisfaction was comparable across the treatment groups .
RESULTS	There were no episodes of severe hypoglycaemia in either group , however , self-recorded episodes of blood glucose 3.9 mmol/l were significantly lower with liraglutide ( incidence rate ratio 0.29 , 95 % CI 0.19 , 0.41 , p < 0.0001 ) .
CONCLUSIONS	Liraglutide compared with sulphonylurea is well tolerated and maybe an effective therapy in combination with metformin during Ramadan with more patients able to achieve target HbA1c , lose or maintain weight with no severe hypoglycaemia .
CONCLUSIONS	This was achieved with a high level of treatment satisfaction .

###25304851
BACKGROUND	Vulval intraepithelial neoplasia is a skin disorder affecting the vulva that , if left untreated , can become cancerous .
BACKGROUND	Currently , the standard treatment for patients with vulval intraepithelial neoplasia is surgery , but this approach does not guarantee cure and can be disfiguring , causing physical and psychological problems , particularly in women of reproductive age .
BACKGROUND	We aimed to assess the activity , safety , and feasibility of two topical treatments -- cidofovir and imiquimod -- as an alternative to surgery in female patients with vulval intraepithelial neoplasia .
METHODS	We recruited female patients ( age 16 years or older ) from 32 centres to an open-label , randomised , phase 2 trial .
METHODS	Eligibility criteria were biopsy-proven vulval intraepithelial neoplasia grade 3 and at least one lesion that could be measured accurately .
METHODS	We randomly allocated patients to topical treatment with either 1 % cidofovir ( supplied as a gel in a 10 g tube , to last 6 weeks ) or 5 % imiquimod ( one 250 mg sachet for every application ) , to be self-applied three times a week for a maximum of 24 weeks .
METHODS	Randomisation ( 1:1 ) was done by stratified minimisation via a central computerised system , with stratification by hospital , disease focality , and presentation stage .
METHODS	The primary endpoint was a histologically confirmed complete response at the post-treatment assessment visit 6 weeks after the end of treatment ( a maximum of 30 weeks after treatment started ) .
METHODS	Analysis of the primary endpoint was by intention to treat .
METHODS	Secondary outcomes were toxic effects ( to assess safety ) and adherence to treatment ( to assess feasibility ) .
METHODS	We present results after all patients had reached the primary endpoint assessment point at 6 weeks ; 2-year follow-up of complete responders continues .
METHODS	This trial is registered with Current Controlled Trials , ISRCTN 34420460 .
RESULTS	Between Oct 21 , 2009 , and Jan 11 , 2013 , 180 participants were enrolled to the study ; 89 patients were randomly allocated cidofovir and 91 were assigned imiquimod .
RESULTS	At the post-treatment assessment visit , a complete response had been achieved by 41 ( 46 % ; 90 % CI 370-553 ) patients allocated cidofovir and by 42 ( 46 % ; 372-553 ) patients assigned imiquimod .
RESULTS	After 6 weeks of treatment , 156 ( 87 % ) patients ( 78 in each group ) had adhered to the treatment regimen .
RESULTS	Five patients in the cidofovir group and seven in the imiquimod group either withdrew or were lost to follow-up before the first 6-week safety assessment .
RESULTS	Adverse events of grade 3 or higher were reported in 31 ( 37 % ) of 84 patients allocated cidofovir and 39 ( 46 % ) of 84 patients assigned imiquimod ; the most frequent grade 3 and 4 events were pain in the vulva , pruritus , fatigue , and headache .
CONCLUSIONS	Cidofovir and imiquimod were active , safe , and feasible for treatment of vulval intraepithelial neoplasia and warrant further investigation in a phase 3 setting .
CONCLUSIONS	Both drugs are effective alternatives to surgery for female patients with vulval intraepithelial neoplasia after exclusion of occult invasive disease .
BACKGROUND	Cancer Research UK .

###24440015
OBJECTIVE	The aim of this study was to determine the relative utility of anatomic and ischemic burden of coronary artery disease for predicting outcomes .
BACKGROUND	Both anatomic burden and ischemic burden of coronary artery disease determine patient prognosis and influence myocardial revascularization decisions .
BACKGROUND	When both measures are available , their relative utility for prognostication and management choice is controversial .
METHODS	A total of 621 patients enrolled in the COURAGE ( Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation ) trial with baseline quantitative nuclear single-photon emission computed tomography ( SPECT ) and quantitative coronary angiography were studied .
METHODS	Several multiple regression models were constructed to determine independent predictors of the endpoint of death , myocardial infarction ( MI ) ( excluding periprocedural MI ) and non-ST-segment elevation acute coronary syndromes ( NSTE-ACS ) .
METHODS	Ischemic burden during stress SPECT , anatomic burden derived from angiography , left ventricular ejection fraction , and assignment to either optimal medical therapy ( OMT ) + percutaneous coronary intervention ( PCI ) or OMT alone were analyzed .
RESULTS	In nonadjusted and adjusted regression models , anatomic burden and left ventricular ejection fraction were consistent predictors of death , MI , and NSTE-ACS , whereas ischemic burden and treatment assignment were not .
RESULTS	There was a marginal ( p = 0.03 ) effect of the interaction term of anatomic and ischemic burden for the prediction of clinical outcome , but separately or in combination , neither anatomy nor ischemia interacted with therapeutic strategy to predict outcome .
CONCLUSIONS	In a cohort of patients treated with OMT , anatomic burden was a consistent predictor of death , MI , and NSTE-ACS , whereas ischemic burden was not .
CONCLUSIONS	Importantly , neither determination , even in combination , identified a patient profile benefiting preferentially from an invasive therapeutic strategy .
CONCLUSIONS	( Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation [ COURAGE ] ; NCT00007657 ) .

###25154607
BACKGROUND	Microvascular angina ( MVA ) is characterized by anginal chest pain , an abnormal stress test , and normal coronary arteries on coronary angiography .
BACKGROUND	Although the exact pathogenesis remains unclear , endothelial dysfunction is a contributing factor .
BACKGROUND	To date , there exists no specific therapy for this disease .
BACKGROUND	Phosphodiesterase-5 inhibitor improves the endothelial function and subsequently microvascular circulation .
BACKGROUND	The aim of this study is to identify whether udenafil offers benefits in the treatment of MVA in female patients , who have a perfusion defect in their cardiac magnetic resonance image ( CMR ) , but normal coronary arteries .
METHODS	The ` Understanding of Chest Pain in Microvascular Disease Proved by Cardiac Magnetic Resonance Image : ( UMPIRE ) ' trial is a multicenter , prospective , randomized , placebo controlled trial , designed to evaluate the effect of udenafil on myocardial ischemia and symptoms in female patients with MVA .
METHODS	The myocardial ischemia will be quantified by myocardial stress perfusion defect in CMR .
METHODS	A total of 80 patients with proven perfusion defect in adenosine-stress CMR will be randomly assigned to either the udenafil treatment group ( daily dose of 100mg ) or the placebo group for three months .
METHODS	The primary endpoint is > 25 % improvement in perfusion defect size in adenosine-stress CMR from baseline .
METHODS	The secondary endpoints include < 25 % improvement in perfusion defect size , chest pain frequency , ST depression in stress test , Duke score in stress test , quality of life ( QoL ) assessment by SF-36 questionnaire , sexual dysfunction assessment by BISF-W ( Brief Index of Sexual Functioning for Women ) self-assessment questionnaire , and biomarkers for endothelial function .
CONCLUSIONS	The UMPIRE trial is the first randomized controlled trial to evaluate the efficacy of udenafil in female MVA patients .
CONCLUSIONS	If udenafil demonstrates cardioprotective effects , it may provide a novel therapeutic option to reduce myocardial ischemia and improve cardiac function in female MVA patients .
BACKGROUND	Clinical Trials.gov : NCT01769482 ( registered on 20 November 2012 ) .

###25491299
OBJECTIVE	Because human bone marrow ( BM ) CD34 + stem cells home into damaged tissue and may play an important role in tissue repair , this pilot clinical trial explored the safety and feasibility of intravitreal autologous CD34 + BM cells as potential therapy for ischemic or degenerative retinal conditions .
METHODS	This prospective study enrolled six subjects ( six eyes ) with irreversible vision loss from retinal vascular occlusion , hereditary or nonexudative age-related macular degeneration , or retinitis pigmentosa .
METHODS	CD34 + cells were isolated under Good Manufacturing Practice conditions from the mononuclear cellular fraction of the BM aspirate using a CliniMACs magnetic cell sorter .
METHODS	After intravitreal CD34 + cell injection , serial ophthalmic examinations , microperimetry/perimetry , fluorescein angiography , electroretinography ( ERG ) , optical coherence tomography ( OCT ) , and adaptive optics OCT were performed during the 6-month follow-up .
RESULTS	A mean of 3.4 million ( range , 1-7 million ) CD34 + cells were isolated and injected per eye .
RESULTS	The therapy was well tolerated with no intraocular inflammation or hyperproliferation .
RESULTS	Best-corrected visual acuity and full-field ERG showed no worsening after 6 months .
RESULTS	Clinical examination also showed no worsening during follow-up except among age-related macular degeneration subjects in whom mild progression of geographic atrophy was noted in both the study eye and contralateral eye at 6-month follow-up , concurrent with some possible decline on multifocal ERG and microperimetry .
RESULTS	Cellular in vivo imaging using adaptive optics OCT showed changes suggestive of new cellular incorporation into the macula of the hereditary macular degeneration study eye .
CONCLUSIONS	Intravitreal autologous BM CD34 + cell therapy appears feasible and well tolerated in eyes with ischemic or degenerative retinal conditions and merits further exploration .
CONCLUSIONS	( ClinicalTrials.gov number , NCT01736059 . )

###25158767
BACKGROUND	The availability of different styles of silicone gel implants-including traditional round devices and shaped , form-stable implants-offers a variety of choices for women undergoing breast augmentation and reconstruction .
BACKGROUND	The purpose of this analysis was to characterize clinical outcomes associated with the Mentor MemoryGel ( round ) MemoryShape/Contour Profile Gel ( shaped ) devices through 9 years of use in women undergoing breast augmentation or reconstruction .
METHODS	The Mentor Core studies are nonrandomized , open-label clinical trials designed to assess the long-term safety and efficacy of silicone gel breast implants .
METHODS	The cumulative incidence of selected complications and reoperations was estimated using the Kaplan-Meier method .
METHODS	Patient satisfaction was assessed by asking the patient if she would decide to have breast implant surgery again .
RESULTS	Shaped implants were associated with lower cumulative incidence rates of Baker Grade III/IV capsular contracture compared with round implants ( 3.4 % vs 11.3 % , respectively , in primary augmentation , P < 0.0001 ; 15.6 % vs 24.4 % in revision-augmentation , P < 0.05 ) .
RESULTS	Reoperation , explantation , and infection rates were comparable between devices across cohorts , except for lower incidence of infection with shaped than round implants in primary reconstruction ( 1.6 % vs 6.2 % , P < 0.05 ) .
RESULTS	Rupture rates were lower with shaped implants , with significance reached in primary augmentation patients at 8 years ( 3.1 % vs 10.3 % , P < 0.05 ) .
RESULTS	High levels of patient satisfaction ( exceeding 94 % ) with both devices were reported at 9 years across cohorts .
CONCLUSIONS	Prospective data through 9 years support comparable safety of round and shaped breast implants , and high levels of patient satisfaction , in patients undergoing primary and revision breast augmentation and reconstruction .

###25421781
BACKGROUND	Obesity is prevalent in individuals with serious mental illness ( SMI ) .
OBJECTIVE	The purpose of this study is to examine the feasibility of a telephone-delivered physical activity ( PA ) intervention for outpatients with serious mental illness to maintain PA and to explore the preliminary efficacy of the intervention on health status .
METHODS	This study used a randomized experimental design .
METHODS	The treatment group received pedometers and eight weekly phone calls ; the control group received written information regarding PA. .
METHODS	Descriptive statistics were used to analyze data collected at baseline and 8 weeks .
RESULTS	Twenty-two subjects with SMI ( mean age = 44.09 7.6 years ; 54.5 % were male ) were recruited and 16 subjects completed the study in 8 weeks .
RESULTS	PA ( z = -2.37 , p = .02 ) increased in the treatment group ( n = 8 ) whereas the control group ( n = 8 ) maintained baseline PA level ( z = -1.61 , p = .11 ) .
RESULTS	Health outcomes were not changed ( ps > .05 ) .
CONCLUSIONS	Telephone-delivered intervention is feasible and has the potential to improve PA in individuals with SMI .

###26521589
OBJECTIVE	To observe the myocardial protective effect of electroacupuncture ( EA ) at Neiguan ( PC 6 ) in the patients with valve replacement via extracorporeal circulation .
METHODS	Fifty patients of rheumatic cardiac disease planned for valve replacement were graded as II or III level according to America Society of Anesthesiologists ( ASA ) and were randomized into an observation group and a control group , 25 cases in each one .
METHODS	The same anesthesia and valve replacement via extracorporeal circulation were adopted in the patients of the two groups .
METHODS	In the observation group , 30 min before operation , EA was used to stimulate bilateral Neiguan ( PC 6 ) till the end of operation .
METHODS	The venous blood was collected at 5 time points separately , named before aorta blockage ( T1 ) , 15 min after aorta open ( T2 ) , 30 min after aorta open ( T3 ) , 6 h after opening ( T4 ) and 24 h after opening ( T5 ) .
METHODS	The concentrations of malondial dehyde ( MDA ) , superoxide dismutase ( SOD ) and cardiac troponin 1 ( cTnI ) were determined in serum .
METHODS	The heart re-beating and the total dosage of vasoactive drugs after operation were recorded .
RESULTS	Compared with those before aorta blockage , MDA and cTnI at each time point of aorta open were all apparently increased in the patients of the two groups ( all P < 0.05 ) , and SOD was reduced apparently ( P < 0.05 ) .
RESULTS	Compared with the control group , at the time points from T3 to T5 , MDA and cTnL were lower apparently in the observation group as compared with those in the control group ( all P < 0.05 ) and SOD was higher than that in the control group ( P < 0.05 ) .
RESULTS	The dosage of vasoactive drugs was reduced apparently ( P < .
RESULTS	05 ) .
CONCLUSIONS	EA at Neiguan ( PC 6 ) alleviates oxidative stress injury and has the protective effect on ischemic reperfusion myocardium .

###24240632
BACKGROUND	Although gastrointestinal ( GI ) , respiratory , and dermal symptoms are common , few studies have conducted concurrent and comparative prospective analyses of risk factors for these 3 morbidity outcomes .
METHODS	We used data from a community-based randomized controlled trial among 277 South Australian families to analyze GI ( diarrhea , vomiting ) , respiratory ( sore throat , runny nose , cough ) and dermal ( rash , generalized itch , dermal infection ) symptoms .
RESULTS	Log-binomial regression analysis revealed similar risks of GI ( adjusted risk ratio [ RR ] , 1.65 ; 95 % CI , 1.05-2 .58 ) and respiratory ( RR , 1.68 ; 95 % CI , 1.31-2 .15 ) symptoms among childcare/kindergarten attendees .
RESULTS	Swimming in public pools/spas in the current or previous week was associated with all 3 symptom complexes , conferring similar risk for each ( RR for GI : 1.33 ; 95 % CI , 0.99-1 .77 ; respiratory : 1.20 ; 95 % CI , 1.04-1 .38 ; dermal : 1.41 ; 95 % CI , 1.08-1 .85 ) .
RESULTS	Pet ownership was not associated with symptoms .
RESULTS	Household clustering of GI and respiratory symptoms was common , and clustering of respiratory symptoms correlated with number of individuals per household .
CONCLUSIONS	This simultaneous examination of risk factors for 3 health outcomes yielded new comparative data that are useful for developing prevention strategies .

###24379278
BACKGROUND	Rather than the absolute dose of diuretic or urine output , the primary signal of interest when evaluating diuretic responsiveness is the efficiency with which the kidneys can produce urine after a given dose of diuretic .
BACKGROUND	As a result , we hypothesized that a metric of diuretic efficiency ( DE ) would capture distinct prognostic information beyond that of raw fluid output or diuretic dose .
RESULTS	We independently analyzed 2 cohorts : ( 1 ) consecutive admissions at the University of Pennsylvania ( Penn ) with a primary discharge diagnosis of heart failure ( n = 657 ) and ( 2 ) patients in the Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness ( ESCAPE ) data set ( n = 390 ) .
RESULTS	DE was estimated as the net fluid output produced per 40 mg of furosemide equivalents , then dichotomized into high versus low DE based on the median value .
RESULTS	There was only a moderate correlation between DE and both intravenous diuretic dose and net fluid output ( r ( 2 ) 0.26 for all comparisons ) , indicating that DE was describing unique information .
RESULTS	With the exception of metrics of renal function and preadmission diuretic therapy , traditional baseline characteristics , including right heart catheterization variables , were not consistently associated with DE .
RESULTS	Low DE was associated with worsened survival even after adjusting for in-hospital diuretic dose , fluid output , in addition to baseline characteristics ( Penn : hazards ratio [ HR ] , 1.36 ; 95 % confidence interval [ CI ] , 1.04-1 .78 ; P = 0.02 ; ESCAPE : HR , 2.86 ; 95 % CI , 1.53-5 .36 ; P = 0.001 ) .
CONCLUSIONS	Although in need of validation in less-selected populations , low DE during decongestive therapy portends poorer long-term outcomes above and beyond traditional prognostic factors in patients hospitalized with decompensated heart failure .

###26436207
BACKGROUND	Whether remote ischemic preconditioning ( transient ischemia and reperfusion of the arm ) can improve clinical outcomes in patients undergoing coronary-artery bypass graft ( CABG ) surgery is not known .
BACKGROUND	We investigated this question in a randomized trial .
METHODS	We conducted a multicenter , sham-controlled trial involving adults at increased surgical risk who were undergoing on-pump CABG ( with or without valve surgery ) with blood cardioplegia .
METHODS	After anesthesia induction and before surgical incision , patients were randomly assigned to remote ischemic preconditioning ( four 5-minute inflations and deflations of a standard blood-pressure cuff on the upper arm ) or sham conditioning ( control group ) .
METHODS	Anesthetic management and perioperative care were not standardized .
METHODS	The combined primary end point was death from cardiovascular causes , nonfatal myocardial infarction , coronary revascularization , or stroke , assessed 12 months after randomization .
RESULTS	We enrolled a total of 1612 patients ( 811 in the control group and 801 in the ischemic-preconditioning group ) at 30 cardiac surgery centers in the United Kingdom .
RESULTS	There was no significant difference in the cumulative incidence of the primary end point at 12 months between the patients in the remote ischemic preconditioning group and those in the control group ( 212 patients [ 26.5 % ] and 225 patients [ 27.7 % ] , respectively ; hazard ratio with ischemic preconditioning , 0.95 ; 95 % confidence interval , 0.79 to 1.15 ; P = 0.58 ) .
RESULTS	Furthermore , there were no significant between-group differences in either adverse events or the secondary end points of perioperative myocardial injury ( assessed on the basis of the area under the curve for the high-sensitivity assay of serum troponin T at 72 hours ) , inotrope score ( calculated from the maximum dose of the individual inotropic agents administered in the first 3 days after surgery ) , acute kidney injury , duration of stay in the intensive care unit and hospital , distance on the 6-minute walk test , and quality of life .
CONCLUSIONS	Remote ischemic preconditioning did not improve clinical outcomes in patients undergoing elective on-pump CABG with or without valve surgery .
CONCLUSIONS	( Funded by the Efficacy and Mechanism Evaluation Program [ a Medical Research Council and National Institute of Health Research partnership ] and the British Heart Foundation ; ERICCA ClinicalTrials.gov number , NCT01247545 . )

###24645324
OBJECTIVE	To study the efficacy of early , enough methylprednisone combined with immunoglobulin in treatments of severe hand-foot-mouth disease .
METHODS	568 patients of severe hand-foot-mouth disease involved were randomized into group A and group B. Patients of both groups all accepted symptomatic treatment , supportive therapy and the treatment of control intracranial pressure .
METHODS	And patients in group A received the treatment of early , enough methylprednisone combined with immunoglobulin , whereas patients in group B received conventional therapy .
METHODS	RESULTS ; Curative rate of group A was better than that of group B , otherwise incidence rate of critical illness was less than that of group B.
METHODS	The control time of fever , erythra , neurological symptoms , features of pneumonia and increased leukocyte of group A was shorter than that of group B , and no more recent or Long-term treatment-related adverse reaction in group A.
CONCLUSIONS	Early , enough methylprednisone combined with immunoglobulin is effective , safe in treating severe hand-foot-mouth disease , and worthy to recommand its clinical use .

###25124692
OBJECTIVE	The individual placement and support model of supported employment has been shown to be more effective than other vocational approaches in improving competitive work over 1-2 years in persons with severe mental illness .
OBJECTIVE	The authors evaluated the longer-term effects of the model compared with traditional vocational rehabilitation over 5 years .
METHODS	A randomized controlled trial compared supported employment to traditional vocational rehabilitation in 100 unemployed persons with severe mental illness .
METHODS	Competitive work and hospital admissions were tracked for 5 years , and interviews were conducted at 2 and 5 years to assess recovery attitudes and quality of life .
METHODS	A cost-benefit analysis compared program and total treatment costs to earnings from competitive employment .
RESULTS	The beneficial effects of supported employment on work at 2 years were sustained over the 5-year follow-up period .
RESULTS	Participants in supported employment were more likely to obtain competitive work than those in traditional vocational rehabilitation ( 65 % compared with 33 % ) , worked more hours and weeks , earned more wages , and had longer job tenures .
RESULTS	Reliance on supported employment services for retaining competitive work decreased from 2 years to 5 years for participants in supported employment .
RESULTS	Participants were also significantly less likely to be hospitalized , had fewer psychiatric hospital admissions , and spent fewer days in the hospital .
RESULTS	The social return on investment was higher for supported employment participants , whether calculated as the ratio of work earnings to vocational program costs or of work earnings to total vocational program and mental health treatment costs .
CONCLUSIONS	The results demonstrate that the greater effectiveness of supported employment in improving competitive work outcomes is sustained beyond 2 years and suggest that supported employment programs contribute to reduced hospitalizations and produce a higher social return on investment .

###25645909
OBJECTIVE	Fructose consumption has risen alongside obesity and diabetes .
OBJECTIVE	Gut hormones involved in hunger and satiety ( ghrelin and PYY ) may respond differently to fructose compared with glucose ingestion .
OBJECTIVE	This study evaluated the effects of glucose and fructose ingestion on ghrelin and PYY in lean and obese adolescents with differing insulin sensitivity .
METHODS	Adolescents were divided into lean ( n = 14 ) , obese insulin sensitive ( n = 12 ) ( OIS ) , and obese insulin resistant ( n = 15 ) ( OIR ) .
METHODS	In a double-blind , cross-over design , subjects drank 75 g of glucose or fructose in random order , serum was obtained every 10 minutes for 60 minutes .
RESULTS	Baseline acyl-ghrelin was highest in lean and lowest in OIR ( P = 0.02 ) .
RESULTS	After glucose ingestion , acyl-ghrelin decreased similarly in lean and OIS but was lower in OIR ( vs. lean , P = 0.03 ) .
RESULTS	Suppression differences were more pronounced after fructose ( lean vs. OIS , P = 0.008 , lean vs. OIR , P < 0.001 ) .
RESULTS	OIS became significantly hungrier after fructose ( P = 0.015 ) .
RESULTS	PYY was not significantly different at baseline , varied minimally after glucose , and rose after fructose .
CONCLUSIONS	Compared with lean , OIS adolescents have impaired acyl-ghrelin responses to fructose but not glucose , whereas OIR adolescents have blunted responses to both .
CONCLUSIONS	Diminished suppression of acyl-ghrelin in childhood obesity , particularly if accompanied by insulin resistance , may promote hunger and overeating .

###25913070
OBJECTIVE	To test the hypothesis that radiotherapy ( RT ) of head and neck squamous cell carcinoma ( HNSCC ) can be improved by hypoxic modification using nimorazole ( NIM ) in association with accelerated fractionation .
METHODS	The protocol was activated in March 2012 as an international multicenter randomized trial in patients with HNSCC .
METHODS	Tumors were treated to a dose of 66-70Gy , 33-35 fractions , 6 fractions per week .
METHODS	NIM was administered in a dose of 1.2 gperm ( 2 ) , 90min before the first daily RT fraction .
METHODS	The primary endpoint was loco-regional failure .
METHODS	The trial was closed prematurely by June 2014 due to poor recruitment .
METHODS	An associated quality assurance program was performed to ensure the consistency of RT with the protocol guidelines .
RESULTS	The trial was dimensioned to include 600 patients in 3years , but only 104 patients were randomized between March 2012 and May 2014 due to the inability to involve three major centers and the insufficient recruitment rate from the other participating centers .
RESULTS	Twenty patients from two centers had to be excluded from the analysis due to the unavailability of the follow-up data .
RESULTS	Among the remaining 84 patients , 82 patients were evaluable ( 39 and 43 patients in the RT+NIM and the RT-alone arms , respectively ) .
RESULTS	The treatment compliance was good with only six patients not completing the full planned RT course , and 31 patients ( 79 % ) out of 39 allocated for NIM , achieving at least 90 % of the prescribed drug dose .
RESULTS	At the time of evaluation , 40 patients had failed to achieve persistent loco-regional tumor control , and a total of 45 patients had died .
RESULTS	The use of NIM improved the loco-regional tumor control with an 18month post-randomization cumulative failure rate of 33 % versus 51 % in the control arm , yielding a risk difference of 18 % ( CI -3 % to 39 % ; P = 0.10 ) .
RESULTS	The corresponding values for overall death was 43 % versus 62 % , yielding a risk difference of 19 % ( CI -3 % to 42 % ; P = 0.10 ) .
RESULTS	Sixteen patients , out of 55 patients analyzed for hypoxic gene expression , were classified as having more hypoxic tumors .
RESULTS	Such patients , if treated with RT alone , had a higher loco-regional tumor failure rate as compared to the rest of the patients with known hypoxic status ( P = 0.05 ) .
CONCLUSIONS	Although the trial was incomplete and suffered from a small number of patients , the results suggested an improvement in loco-regional tumor control and overall survival in patients with advanced HNSCC given the hypoxic modifier NIM in addition to accelerated fractionation RT. .
CONCLUSIONS	However , the trial also revealed that conducting multicenter and multinational study combining drug and RT in developing countries may suffer from uncontrolled and unsolvable problems .

###25220898
BACKGROUND	Pain is highly prevalent among persons with HIV .
BACKGROUND	Alcohol may be used to `` self-medicate '' pain .
BACKGROUND	This study examined the association between pain and risky alcohol use over time in a cohort of HIV-infected Russian drinkers .
METHODS	This secondary analysis utilized longitudinal data from a randomized trial of a behavioral intervention .
METHODS	Subjects included HIV-infected adults who reported past 6-month risky drinking and unprotected sex and were recruited from HIV and addiction treatment sites in St. Petersburg , Russia .
METHODS	The main independent variable was pain that at least moderately interfered with daily living .
METHODS	The primary outcome was past month risky drinking amounts based on NIAAA guidelines .
METHODS	General estimating equations ( GEE ) logistic regression models were used to calculate odds ratios and 95 % confidence intervals for the association between pain and risky drinking over time ( i.e. , baseline , 6 and 12 months ) , adjusting for potential confounders .
RESULTS	Baseline characteristics of participants ( n = 699 ) were mean age of 30 ( SD 5 ) years , 41 % female , and 22 % < 9th grade education .
RESULTS	Nearly one quarter ( 24 % ) had a CD4 cell count < 200 cells/l , and only 17 % were on antiretroviral therapy .
RESULTS	Nearly half ( 46 % ) reported at least moderate pain interference in the past month and 81 % were drinking risky amounts .
RESULTS	In adjusted longitudinal GEE models , pain was significantly associated with greater odds of reporting past month risky drinking ( AOR = 1.34 , 95 % CI : 1.05-1 .71 , p value = 0.02 ) .
CONCLUSIONS	Among a cohort of HIV-infected Russian drinkers , pain that at least moderately interfered with daily living was associated with higher odds of reporting risky drinking amounts over time .

###25492271
BACKGROUND	Sideroblastic cardiomyopathy secondary to repeated blood transfusions is a feared complication in thalassaemia .
BACKGROUND	Control of myocardial iron is thus becoming the cornerstone of thalassaemia management .
BACKGROUND	Recent evidence suggests a role for L-type Ca ( 2 + ) channels in mediating iron uptake by the heart .
BACKGROUND	Blocking the cellular iron uptake through these channels may add to the benefit of therapy to standard chelation in reducing myocardial iron .
BACKGROUND	We aim to determine the efficacy of amlodipine ( a calcium channel blocker ) as an adjunct to standard aggressive chelation in retarding myocardial iron deposition in thalassaemics with or without cardiomyopathy .
RESULTS	The primary outcome is to compare the efficacy of amlodipine + chelation ( intervention ) versus standard chelation ( control ) in retarding myocardial iron deposition .
RESULTS	Secondary outcomes include the effect of amlodipine therapy on systolic and diastolic function , strain and strain rate and liver iron content .
METHODS	This is a single-centre , parallel-group , prospective randomised control trial .
METHODS	Twenty patients will be randomised in a 1:1 allocation ratio into the intervention and control arms .
METHODS	In addition to conventional echocardiography , MRI T2 * values for assessment of cardiac and liver iron load will be obtained at baseline and at 6 and 12 months .
METHODS	Cardiac T2 * will be reported as the geometric mean and per cent coefficient of variation , and an increase in cardiac T2 * values from baseline will be used as an end point to compare the efficacy of therapy .
METHODS	A p Value of < 0.05 will be considered significant .
METHODS	Department of Pediatric and Child Health , Aga Khan University Hospital , Karachi , Pakistan .
BACKGROUND	This study has been approved by the Ethics Review Committee and Clinical Trials Unit at The Aga Khan University with respect to scientific content and compliance with applicable research and human subjects regulations .
BACKGROUND	Findings will be reported through scientific publications and research conferences and project summary papers for participants .
BACKGROUND	ClinicalTrials.Gov .
BACKGROUND	Registration no : NCT02065492 .

###24820191
OBJECTIVE	The logistic European System for Cardiac Operative Risk Evaluation ( LES ) score and the Society of Thoracic Surgeons ( STS ) score are validated to predict 30-day outcomes following surgical aortic valve replacement ( SAVR ) with or without coronary artery bypass grafting .
OBJECTIVE	Their performance when applied to patients undergoing transcatheter aortic valve replacement ( TAVR ) is controversial .
METHODS	We compared predicted and observed 30-day/in-hospital and 1-year mortality of patients undergoing TAVR in the first Placement of Aortic Transcatheter Valves trial and continued access registry ( N = 2466 ) .
METHODS	The performance of the LES and STS scores ( prospectively calculated ) was evaluated using standard assessments of discrimination and calibration .
METHODS	Performance of STS and LES scores among 307 patients undergoing SAVR from the high-risk cohort of the randomized trial were also examined .
RESULTS	In patients undergoing TAVR , the observed 30-day/in-hospital mortality was 6.5 % , whereas the predicted 30-day mortality was higher by both STS score ( 11.4 % 3.9 % ) and LES score ( 26.6 % 16.2 % ) .
RESULTS	The discrimination for both scores was poor for 30-day/in-hospital and 1-year mortality .
RESULTS	Calibration was better for STS score than for LES at 1 year but poor for both at 30 days among TAVR cohort .
RESULTS	These results were consistent among the subgroups of patients undergoing transfemoral and transapical access ; however , the STS score had better performance among the high-risk patients who underwent SAVR at 30 days but not 1 year .
CONCLUSIONS	The STS and LES surgical risk scores overestimated 30-day/in-hospital mortality and were poor discriminators of post-TAVR mortality , but the calibration of the STS score was better in these high-risk patients .
CONCLUSIONS	These data highlight the need for TAVR-specific risk models to optimize patient selection .

###25325491
OBJECTIVE	Measures of health-related quality of life ( HRQL ) specific for sleep disorders have had limited psychometric evaluation in the context of randomized controlled trials ( RCTs ) .
OBJECTIVE	We investigated the psychometric properties of the Functional Outcomes of Sleep Questionnaire ( FOSQ ) and Sleep Apnea Quality of Life Instrument ( SAQLI ) .
OBJECTIVE	We evaluated the FOSQ and SAQLI construct and criterion validity , determined a minimally important difference , and assessed for associations of responsiveness to baseline subject characteristics and continuous positive airway pressure ( CPAP ) adherence in a RCT population .
METHODS	Secondary analysis of data collected in a multisite RCT of home versus laboratory-based diagnosis and treatment of obstructive sleep apnea ( HomePAP trial ) .
METHODS	Individuals enrolled in the HomePAP trial ( n = 335 ) .
METHODS	N/A .
RESULTS	The FOSQ and SAQLI subscores demonstrated high reliability and criterion validity , correlating with Medical Outcomes Study 36-Item Short Form Survey domains .
RESULTS	Correlations were weaker with the Epworth Sleepiness Scale ( ESS ) .
RESULTS	Both the FOSQ and SAQLI scores improved after 3 mo with CPAP therapy .
RESULTS	Averaging 4 h or more of CPAP use was associated with an increase in the FOSQ beyond the minimally important difference .
RESULTS	Baseline depressive symptoms and sleepiness predicted FOSQ and SAQLI responsiveness ; demographic , objective obstructive sleep apnea ( OSA ) severity and sleep habits were not predictive in linear regression .
CONCLUSIONS	The FOSQ and SAQLI are responsive to CPAP intervention , with the FOSQ being more sensitive to differences in CPAP adherence than the SAQLI .
CONCLUSIONS	These instruments provide unique information about health outcomes beyond that provided by changes in physiological measures of OSA severity ( apnea-hypopnea index ) .
BACKGROUND	Portable Monitoring for Diagnosis and Management of Sleep Apnea ( HomePAP ) URL : http://clinicaltrials.gov/show/NCT00642486 .
BACKGROUND	NIH clinical trials registry number : NCT00642486 .

###25107685
OBJECTIVE	Children with epilepsy may have comorbidities that result in significant disability .
OBJECTIVE	Epidemiological information for pediatric patients with epilepsy in Taiwan is scant .
OBJECTIVE	This research estimates the prevalence and common neuro-psychiatric comorbidities of children with epilepsy in Taiwan .
METHODS	Patients aged less than 20 years old who had received a diagnosis of epilepsy and suffered from epileptic seizures in 2005 were identified in the NHIRD based on ICD-9-CM and prescription records for the use of at least one AED .
METHODS	We used cases of epileptic seizure to survey outpatient service data , and identify common neuro-psychiatric comorbidities .
METHODS	The crude prevalence rate and the age - and sex-specific prevalence were estimated .
METHODS	We also examined the effects of urbanization .
RESULTS	The estimated prevalence of epilepsy was 0.33 % in the pediatric population , with 0.29 % for girls and 0.36 % for boys .
RESULTS	The most common neuropsychiatric comorbidities were learning disability and developmental delay , cerebral palsy , and mental retardation .
RESULTS	Epilepsy was more prevalent in boys than in girls , especially among infants , preschool children , and those living in rural areas .
RESULTS	In addition , boys with epilepsy had a higher rate of neurological comorbidities .
RESULTS	The prevalence of psychiatric comorbidities was lower than that reported in previous studies performed in other countries , especially among children with epilepsy living in rural areas .
CONCLUSIONS	This research provides the largest nationwide , population-based study of childhood epilepsy to estimate the prevalence and the associated neuropsychiatric comorbidities of pediatric epilepsy in Taiwan .
CONCLUSIONS	Potential rural-urban disparity basing on prevalence and associated neuropsychiatric comorbidities can not be ignored in Taiwan .

###24400593
OBJECTIVE	While stimulation of the peripheral nerves increases the pain threshold , chronic pressure stimulation of the sciatic nerve is associated with sciatica .
OBJECTIVE	We recently found that acute pressure block of the sciatic nerve inhibits pain .
OBJECTIVE	Therefore , we propose that , the pain pathology-causing pressure is chronic , not acute .
OBJECTIVE	Here , we report a novel self-administered method : acute pressure block of the sciatic nerves is applied by the patients themselves for short-term relief of pain from dental diseases .
METHODS	This was a randomized , single-blind study .
METHODS	Hospital patients .
METHODS	Patients aged 16-60 years with acute pulpitis , acute apical periodontitis , or pericoronitis of the third molar of the mandible experiencing pain 3 on the 11-point numerical pain rating scale .
METHODS	Three-minute pressure to sciatic nerves was applied by using the hands ( hand pressure method ) or by having the patients squat to force the thigh and shin as tightly as possible on the sandwiched sciatic nerve bundles ( self-administered method ) .
RESULTS	The primary efficacy variable was the mean difference in pain scores from the baseline .
RESULTS	One hundred seventy-two dental patients were randomized .
RESULTS	The self-administered method produced significant relief from pain associated with dental diseases ( P0 .001 ) .
RESULTS	The analgesic effect of the self-administered method was similar to that of the hand pressure method .
CONCLUSIONS	The self-administered method is easy to learn and can be applied at any time for pain relief .
CONCLUSIONS	We believe that patients will benefit from this method .

###24701571
BACKGROUND	The aim of the study was to compare the sensory , motor , and neuroophthalmological effects of isobaric levobupivacaine and bupivacaine when intrathecally administered .
METHODS	A prospective , double-blind , randomized study with 60 ASA grade I-II patients aged 18-65 years awaiting knee arthroscopy under spinal anesthesia .
METHODS	Patients received 12.5 mg of isobaric bupivacaine or levobupivacaine .
METHODS	Several features were recorded .
RESULTS	No significant intergroup differences were observed for ASA classification , time to micturate , demographic data , surgery duration , and patient/surgeon satisfaction .
RESULTS	Similar hemodynamic parameters and sensory/motor blockade duration were found for both groups .
RESULTS	There were no neuroophthalmological effects in either group .
RESULTS	Sensory ( P = 0.018 ) and motor blockade onset ( P = 0.003 ) was faster in the bupivacaine group .
RESULTS	T6 ( T2-T12 ) and T3 ( T2-T12 ) were the highest sensory block levels for the levobupivacaine and bupivacaine groups , respectively ( P = 0.008 ) .
RESULTS	It took less time to regain maximum motor blockade in the bupivacaine group ( P = 0.014 ) , and the levobupivacaine group required use of analgesia earlier ( P = 0.025 ) .
CONCLUSIONS	Isobaric bupivacaine and levobupivacaine are analogous and well-tolerated anesthetics for knee arthroscopy .
CONCLUSIONS	However , for bupivacaine , sensory and motor blockade onset was faster , and greater sensory blockade with a longer postoperative painless period was achieved .

###24326693
BACKGROUND	Neurogenic orthostatic hypotension ( nOH ) is common in Parkinson 's disease ( PD ) , and represents a failure to generate norepinephrine responses appropriate for postural change .
BACKGROUND	Droxidopa ( L-threo-3 ,4 - dihydroxyphenylserine ) is an oral norepinephrine prodrug .
OBJECTIVE	Interim analyses of the initial patients enrolled in a multicenter , randomized , double-blind , placebo-controlled phase 3 trial of droxidopa for nOH in PD ( ClinicalTrials.gov Identifier : NCT01176240 ) .
METHODS	PD patients with documented nOH underwent 2 weeks of double-blind droxidopa or placebo dosage optimization followed by 8 weeks of maintenance treatment ( 100-600 mg t.i.d. ) .
METHODS	The primary efficacy measure was change in Orthostatic Hypotension Questionnaire ( OHQ ) composite score from baseline to Week 8 .
METHODS	Key secondary variables included dizziness/lightheadedness score ( OHQ item 1 ) and patient-reported falls .
RESULTS	Among 24 droxidopa and 27 placebo recipients , mean OHQ composite-score change at Week 8 was -2.2 versus -2.1 ( p = 0.98 ) ; in response to this pre-planned futility analysis , the study was temporarily stopped and all data from these patients were considered exploratory .
RESULTS	At Week 1 , mean dizziness/lightheadedness score change favored droxidopa by 1.5 units ( p = 0.24 ) , with subsequent numerical differences favoring droxidopa throughout the observation period , and at Week 1 , mean standing systolic blood-pressure change favored droxidopa by 12.5 mmHg ( p = 0.04 ) .
RESULTS	Compared with placebo , the droxidopa group exhibited an approximately 50 % lower rate of reported falls ( p = 0.16 ) and fall-related injuries ( post-hoc analysis ) .
CONCLUSIONS	This exploratory analysis of a small dataset failed to show benefit of droxidopa , as compared with placebo by the primary endpoint .
CONCLUSIONS	Nonetheless , there were signals of potential benefit for nOH , including improvement in dizziness/lightheadedness and reduction in falls , meriting evaluation in further trials .

###24999076
BACKGROUND	The management of perioperative period for patients with spontaneous intracerebral hemorrhage affects the prognosis .
BACKGROUND	Elevated blood pressure is common in the patients with spontaneous intracerebral hemorrhage and related to a poor outcome .
BACKGROUND	However , study on antihypertensive treatment for surgical patients with spontaneous intracerebral hemorrhage is insufficient .
OBJECTIVE	To determine if the intensive antihypertensive treatment improves the prognosis compared with the conservative antihypertensive treatment followed guidelines in perioperative period for patients with spontaneous intracerebral hemorrhage .
METHODS	PATICH is a prospective , parallel , randomized , assessor-blinded trial .
METHODS	Two hundred eligible patients will be assigned to the intensive group and conservative group randomly .
METHODS	Patients allocated to the intensive group will receive an intensive antihypertensive treatment aiming to achieve a target systolic blood pressure of between 120 mmHg and 140 mmHg while the patients in the conservative group will receive conservative antihypertensive treatment as recommended by guidelines for 7 days .
METHODS	Operation will be conducted by well-trained surgeons and the best medical treatment will be given in all patients .
METHODS	Patients will be followed up at 7 days , 30 days , and 90 days .
RESULTS	Primary outcome of this study is the rate of rehemorrhage in 7 days after surgery .
RESULTS	Secondary outcomes include death and dependency at 90 days incidence of ischemic stroke , separate rate of death and dependency at 90 days , health related quality of life ( HRQoL ) at 90 days , incidence of other vascular events , and days of hospitalization .
RESULTS	Dependency is defined by a score of 3-5 based on the modified Rankin Scale ( mRS ) .

###24384588
OBJECTIVE	To compare the effect that initiating different antiretroviral therapy ( ART ) regimens has on weight , BMI , and lean body mass ( LBM ) and explore how changes in body composition are associated with bone mineral density ( BMD ) .
METHODS	A5224s was a sub-study of A5202 , a prospective trial of 1857 ART-naive participants randomized to blinded abacavir-lamivudine ( ABC/3TC ) or tenofovir DF-emtricitabine ( TDF/FTC ) with open-label efavirenz ( EFV ) or atazanavir-ritonavir ( ATV/r ) .
METHODS	All participants underwent dual-energy absorptiometry ( DXA ) and abdominal computed tomography for body composition .
METHODS	Analyses used two-sample t-tests and linear regression .
RESULTS	A5224s included 269 participants : 85 % men , 47 % white non-Hispanic , median age 38 years , HIV-1 RNA 4.6 log10 copies/ml , and CD4 cell count 233 cells/l .
RESULTS	Overall , significant gains occurred in weight , BMI , and LBM at 96 weeks post-randomization ( all P < 0.001 ) .
RESULTS	Assignment to ATV/r ( vs. EFV ) resulted in significantly greater weight ( mean difference 3.35 kg ) and BMI gain ( 0.88 kg/m ; both P = 0.02 ) , but not LBM ( 0.67 kg ; P = 0.15 ) , whereas ABC/3TC and TDF/FTC were not significantly different ( P0 .10 ) .
RESULTS	In multivariable analysis , only lower baseline CD4 cell count and higher HIV-1 RNA were associated with greater increase in weight , BMI , or LBM .
RESULTS	In multivariable analyses , increased LBM was associated with an increased hip BMD .
CONCLUSIONS	ABC/3TC vs. TDF/FTC did not differ in change in weight , BMI , or LBM ; ATV/r vs. EFV resulted in greater weight and BMI gain but not LBM .
CONCLUSIONS	A positive association between increased LBM and increased hip BMD should be further investigated through prospective interventional studies to verify the impact of increased LBM on hip BMD .

###25813447
OBJECTIVE	Preservation of renal function is prioritized during surgical management of localized renal cell carcinoma .
OBJECTIVE	VEGF targeted agents can downsize tumors in metastatic renal cell carcinoma and may do the same in localized renal cell carcinoma , allowing for optimal preservation of renal parenchyma associated with partial nephrectomy .
METHODS	Localized clear cell renal cell carcinoma patients meeting 1 or both of the following criteria were enrolled in a prospective phase II trial , including radical or partial nephrectomy likely to yield a glomerular filtration rate of less than 30 ml/minute/1 .73 m ( 2 ) , or partial nephrectomy high risk due to high complexity ( R.E.N.A.L. 10 to 12 ) or tumor adjacent to hilar vessels .
METHODS	Pazopanib ( 800 mg once daily ) was administered for 8 to 16 weeks with repeat imaging at completion of therapy , followed by surgery .
RESULTS	A total of 25 patients enrolled with a median tumor size of 7.3 cm and a median R.E.N.A.L. score of 11 .
RESULTS	Of index lesions 80 % were high complexity and 56 % of patients had a solitary kidney .
RESULTS	Patients received a median of 8 weeks of pazopanib .
RESULTS	The median interval from treatment start to surgery was 10.6 weeks .
RESULTS	R.E.N.A.L. score decreased in 71 % of tumors and 92 % of patients experienced a reduction in tumor volume .
RESULTS	Six of 13 patients for whom partial nephrectomy was not possible at baseline were able to undergo partial nephrectomy after treatment .
RESULTS	The mean parenchymal volume that could be saved with surgery increased from an estimated 107 to 173 cc ( p = 0.0015 ) .
RESULTS	In 5 patients a urine leak developed , which was managed conservatively , and 7 received a transfusion , of whom 1 required embolization .
CONCLUSIONS	Neoadjuvant pazopanib resulted in downsizing localized renal cell carcinoma , allowing for improved preservation of renal parenchyma and enabling partial nephrectomy in a select subset of patients who would otherwise require radical nephrectomy .

###24836523
OBJECTIVE	To evaluate the influence of attenuation-based tube potential selection ( ATPS ) in combination with organ-specific dose reduction ( OSDR ) on radiation dose and image quality of contrast-enhanced chest computed tomography ( CT ) examinations .
METHODS	Seventy consecutive patients ( 59.216.1 years ; 49 men ; 21 women ) were randomized into two groups and underwent contrast-enhanced chest CT using a 128 section CT scanner .
METHODS	CT examinations were performed as standard protocol in group A ( n = 35 ) and with the activated novel dose-saving devices , OSDR and ATPS , in group B ( n = 35 ) .
METHODS	Objective [ signal-to-noise ( SNR ) and contrast-to-noise ratio ( CNR ) ] and subjective image quality ( five-point scale ; 1 = non diagnostic ; 5 = excellent ) as well as radiation dose ( CTDIvol ) were analysed .
RESULTS	CTDIvol of the protocol using OSDR and ATPS was significantly lower than in standard chest CT examinations ( 3.41 versus 6.12.3 mGy ; p < 0.001 ) .
RESULTS	Although the level of noise was slightly elevated in group B ( 14.11.7 versus 11.41.9 HU ; p < 0.01 ) , no significant differences in SNR ( 17.15 versus 16.34.7 ) or subjective image quality ( mean score of 4.6 versus 4.4 ) were observed between both imaging protocols .
CONCLUSIONS	Attenuation-based tube potential selection in combination with organ-specific dose reduction essentially reduces the dose of chest CT in patients with normal body mass index ( BMI ) in clinical routine while maintaining subjective and objective image quality .

###25304269
OBJECTIVE	To compare the therapeutic effects of metformin ( Met ) and laparoscopic ovarian drilling ( LOD ) in clomiphene and insulin-resistant patients with polycystic ovary syndrome ( CIRPCOS ) .
METHODS	A total of 110 patients were randomly divided into two groups .
METHODS	One group was administered Met ( n = 55 ) , while the other group underwent LOD ( n = 55 ) .
METHODS	Rates of ovulation , pregnancy , and abortion were compared between both groups .
RESULTS	Rates of normal menstruation , ovulation , and pregnancy in the LOD group were higher than in the Met group : 76.4 % ( 42/55 ) vs. 58.2 % ( 32/55 ) , P < 0.04 ; 50.8 % ( 11/258 ) vs. 33.5 % ( 94/281 ) , P < 0.001 ; 38.2 % ( 21/55 ) vs. 20.0 % ( 11/55 ) , P < 0.03 .
RESULTS	The difference in the early abortion rate between both groups was not statistically significant .
CONCLUSIONS	Although Met can significantly improve a patient 's insulin resistance , we found that in patients diagnosed with CIRCPOS , LOD can be much more effective in improving rates of normal menstruation , ovulation , and pregnancy .

###24306767
OBJECTIVE	To compare self-reported pedometer steps with accelerometer steps under free-living conditions in individuals with Parkinson 's disease ( PD ) or osteoporosis ( OP ) .
METHODS	Seventy-three individuals with PD and 71 individuals with OP wore a pedometer ( Yamax LS2000 ) and an accelerometer ( ActiGraph GT1M/GT3X + ) simultaneously for one week .
RESULTS	Fifty-one individuals with PD ( 72.6 5.3 years ) and 61 with OP ( 75.6 5.3 years ) provided simultaneously recorded data for 3-7 consecutive days .
RESULTS	Pedometer steps were significantly lower than accelerometer steps in the PD group ( p = .002 ) but not in the OP group ( p = .956 ) .
RESULTS	Bland-Altman plots demonstrated wide limits of agreement between the instruments in both PD ( range = 6,911 steps ) and OP ( range = 6,794 steps ) .
CONCLUSIONS	These results suggest that the ActiGraph GT1M/GT3X + should be preferred over the Yamax LS2000 for the assessment of steps in both research and clinical evaluations , particularly in individuals with PD or altered gait .

###25394855
BACKGROUND	It is not uncommon for patients with ischemic stroke to have peripheral arterial disease ( PAD ) .
BACKGROUND	Patients with polyvascular diseases carry greater burden of atherosclerosis and higher risks of developing vascular events and death .
BACKGROUND	More effective regimens , such as dual antiplatelet agents , may be more effective for controlling progression of atherosclerosis in secondary prevention .
OBJECTIVE	This study aims to evaluate whether cilostazol plus aspirin is more efficacious than aspirin alone for preventing progression of atherosclerosis in patients with ischemic stroke or transient ischemic attack ( TIA ) who also have peripheral arterial disease .
METHODS	The Safety and Efficacy of Cilostazol in Ischemic Stroke Patients with Peripheral Arterial Disease ( SPAD ) study is a randomized double-blinded placebo-controlled trial .
METHODS	Patients with previous ischemic stroke or TIA who had been taking aspirin ( 100mg per day ) , aged 50 years or older , with PAD in the lower limbs based on ankle-brachial index ( ABI ) < 10 will be randomized into the treatment group with cilostazol ( 200mg/day ) or the placebo group on 1:1 basis .
RESULTS	Patients will be evaluated at 1 , 3 , 6 , 9 and 12 months after randomization .
RESULTS	The primary endpoint is difference in change in ABI between groups .
RESULTS	The secondary and tertiary endpoints are the difference between groups in change in carotid intima-media thickness ( IMT ) and incidence rate of major cardiovascular events , including recurrent stroke , myocardial infarction , unstable angina , other vascular events , and death ; and the safety measures , including major bleeding events , hemorrhagic stroke and death of any cause .
CONCLUSIONS	The SPAD trial is the first study to evaluate the safety and efficacy of dual antiplatelet agents , aspirin plus cilostazol , in comparison with aspirin alone in patients with both ischemic stroke or TIA and PAD .
CONCLUSIONS	Results from this trial will provide important information on the merit of adding cilostazol to aspirin for slowing down progression of atherosclerosis in patients with ischemic stroke and PAD .

###24983542
OBJECTIVE	Maraviroc , a chemokine co-receptor type 5 ( CCR5 ) antagonist , has demonstrated comparable efficacy and safety to efavirenz , each in combination with zidovudine/lamivudine , over 96 weeks in the Maraviroc vs. Efavirenz Regimens as Initial Therapy ( MERIT ) study .
OBJECTIVE	Here we report 5-year findings .
METHODS	A randomized , double-blind , multicenter phase IIb/III study with an open-label extension phase .
METHODS	Treatment-naive patients with CCR5-tropic HIV-1 infection ( Trofile ) received maraviroc 300 mg twice daily or efavirenz 600 mg once daily , and zidovudine/lamivudine 300 mg/150 mg twice daily .
METHODS	After the last patient 's week 96 visit , the study was unblinded and patients could enter a nominal 3-year open-label phase .
METHODS	Endpoints at the 5-year nominal visit ( week 240 ) included proportion of patients ( CCR5 tropism re-confirmed by enhanced sensitivity Trofile ) with viral load ( plasma HIV-1 RNA ) below 50 and 400 copies/ml , and change from baseline in CD4 ( + ) cell count , as well as safety .
RESULTS	The proportion of patients maintaining viral load below 50 copies/ml was similar between treatment arms throughout the study and at week 240 ( maraviroc 50.8 % vs. efavirenz 45.9 % ) .
RESULTS	Maraviroc-treated patients had a greater increase from baseline in mean CD4 ( + ) cell count than efavirenz-treated patients at week 240 ( 293 vs. 271 cells/l , respectively ) .
RESULTS	Fewer patients on maraviroc vs. efavirenz experienced treatment-related adverse events ( 68.9 vs. 81.7 % ) and discontinued as a result of any adverse event ( 10.6 vs. 21.3 % ) .
CONCLUSIONS	Maraviroc maintained similar long-term antiviral efficacy to efavirenz over 5 years in treatment-naive patients with CCR5-tropic HIV-1 .
CONCLUSIONS	Maraviroc was generally well tolerated with no unexpected safety findings or evidence of long-term safety concerns .

###25959708
BACKGROUND	Management of contaminated patients in the decontamination corridor requires the use of hazardous material ( HazMat ) personal protective equipment ( PPE ) .
BACKGROUND	Previous studies have demonstrated that HazMat PPE may increase the difficulty of airway management .
BACKGROUND	This study compared the efficiency of video laryngoscopy ( VL ) with traditional direct laryngoscopy ( DL ) during endotracheal intubation ( ETI ) while wearing HazMat PPE .
METHODS	Post-graduate year ( PGY ) 1-3 Emergency Medicine residents were randomized to VL or DL while wearing encapsulating PPE .
METHODS	Video laryngoscopy was performed using the GlideScope Cobalt AVL video laryngoscope .
METHODS	The primary outcome measure was time to successful ETI in a high-fidelity simulation mannequin .
METHODS	Three time points were utilized in the analysis : Time 0 ( blade at lips ) , Time 1 ( blade removed from lips after endotracheal tube placement ) , and Time 2 ( bag valve mask [ BVM ] attached to endotracheal tube ) .
METHODS	Secondary outcome measures were perceived ease of use and feasibility of VL and DL ETI modalities .
RESULTS	Twenty-one of 23 ( 91.3 % ) eligible residents participated .
RESULTS	Mean time to ETI was 10.0 seconds ( SD = 5.3 seconds ) in the DL group and 7.8 seconds ( SD = 3.0 seconds ) in the VL group ( P = .081 ) .
RESULTS	Mean times from blade insertion until BVM attachment were 17.4 seconds ( SD = 6.0 seconds ) and 15.6 seconds ( SD = 4.6 seconds ) , respectively ( P = .30 ) .
RESULTS	There were no unsuccessful intubation attempts .
RESULTS	Seventeen out of 20 participants ( 85.0 % ) perceived VL to be easier to use when performing ETI in PPE .
RESULTS	Twelve out of 20 participants ( 60 % ) perceived DL to be more feasible in an actual HazMat scenario .
CONCLUSIONS	The time to successful ETI was not significantly different between VL and DL .
CONCLUSIONS	Video laryngoscopy had a greater perceived ease of use , but DL was perceived to be more feasible for use in actual HazMat situations .
CONCLUSIONS	These findings suggest that both DL and VL are reasonable modalities for use in HazMat situations , and the choice of modality could be based on the clinical situation and provider experience .

###24508364
BACKGROUND	Although quantitative right ventricular ( RV ) strain analysis may be useful in congenital and acquired heart disease populations with RV failure , a comprehensive , standardized approach is lacking .
BACKGROUND	An 18-segment RV strain analysis obtained from three standardized RV apical echocardiographic images was used to determine the feasibility , normal values , and reproducibility of the method in normal adults .
METHODS	Forty healthy , prospectively enrolled volunteers with no cardiac histories and normal QRS durations underwent echocardiography optimized for strain analysis including three RV apical views .
METHODS	Two-dimensional speckle-tracking longitudinal strain analysis was performed using EchoPAC software .
METHODS	Eleven retrospectively identified subjects with RV disease were included as a pilot population .
METHODS	All had been imaged using the same protocol including the three RV apical views .
RESULTS	All control subjects had normal anatomic morphology and function by echocardiography .
RESULTS	Feasibility of the RV strain analysis was good ( adequate tracking in 696 of 720 segments [ 97 % ] ) .
RESULTS	RV global peak systolic strain was -23 2 % .
RESULTS	Peak strain was highest in the RV free wall and lowest in the septum .
RESULTS	Dyssynchrony indices demonstrated no dyssynchrony using left ventricular criteria .
RESULTS	Reproducibility of most strain measures was acceptable .
RESULTS	This methodology identified important disease not seen in the four-chamber apical view alone in the pilot population of 11 patients with RV disease .
RESULTS	Strain patterns and values were different from those in the control population , indicating that differences do exist from normal .
CONCLUSIONS	Eighteen-segment RV strain analysis is feasible , with strain measures falling into discrete ranges in this normal population .
CONCLUSIONS	Those with RV disease illustrate the potential utility of this approach .
CONCLUSIONS	These data indicate that this model can be used for more detailed studies evaluating abnormal RV populations , in which its full potential can be assessed .

###25200552
BACKGROUND	Hypovitaminosis D is particularly common among older people with a proximal femoral ( hip ) fracture .
BACKGROUND	There are currently no agreed strategies for vitamin D replenishment after hip fracture surgery .
BACKGROUND	The REVITAHIP Study is a multisite , double-blinded randomized-controlled trial investigating the effects of an oral vitamin D loading dose on gaitvelocity after hip fracture surgery .
BACKGROUND	We describe the baseline characteristics of participants , aiming to document hypovitaminosis D and its associations after hip fracture .
METHODS	Participants , over 65 , recruited within 7 days following hip fracture surgery from 3 Australia hospitals , were randomly allocated to receive a loading dose of vitamin D3 ( 250,000 IU ) or placebo , followed by oral maintenance vitamin D3/calcium ( 800 IU/500 mg ) and the usual hip fracture rehabilitation pathway.Demographic and clinical data were collected , including surgical procedure , pre-fracture functional status , Mini Mental State Examination ( MMSE ) score , serum 25-hydroxyvitamin D ( 25-OHD ) , Verbal Rating Scale ( VRS ) for pain , grip strength and gait velocity .
METHODS	The associations of baseline 25-OHD levels with demographic and clinical data were assessed using Pearson 's correlation , ANOVA and regression analyses .
RESULTS	Two-hundred-and-eighteen people with hip fracture participated in the study .
RESULTS	Mean age was 83.9 + / -7.2 years , 77 % were women and 82 % lived in privatehomes .
RESULTS	Fifty-six percent had a subcapital fracture .
RESULTS	Mean comorbidity count was 3.13 + / -2.0 .
RESULTS	Mean MMSE was 26.1 + / -3.9 .
RESULTS	Forty-seven percent of participants had hypovitaminosis D ( < 50 nmol/L ) .
RESULTS	Multivariate regression models demonstrated higher baseline vitamin D levels were significantly associated with higher premorbid Barthel index scores , lower post-operative VRS pain levels and use of vitamin D.
CONCLUSIONS	This study cohort shared similar demographic characteristics and comorbidities with other cohorts of people with hip fracture , with the probable exception of less cognitive impairment .
CONCLUSIONS	Hypovitaminosis D was not as prevalent as previously documented .
CONCLUSIONS	Patients taking vitamin D supplements and with higher premorbid Barthel index , reflecting greater independence and activity , tended to have higher 25-OHD levels at baseline .
CONCLUSIONS	Further , lower VRS pain ratings following surgery were associated with higher vitamin D levels .
CONCLUSIONS	Such associations will need further investigation to determine causation .
CONCLUSIONS	( ANZCTR number , ACTRN12610000392066 ) .
BACKGROUND	The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry ANZCTRN ACTRN12610000392066 .

###25842457
OBJECTIVE	To evaluate the effectiveness of a desensitizing gel for topical and home use for the treatment of dentin hypersensitivity ( DH ) by means of a 3-arm parallel , randomized , double blind clinical trial .
METHODS	107 participants were allocated to three groups : placebo gel ( PG ) , test gel ( TG ) ( 5 % sodium fluoride , 5 % potassium oxalate , 10 % strontium chloride ) and 2 % sodium fluoride gel ( FG ) .
METHODS	DH measurement was performed by a single blind examiner by means of the visual analog scale ( VAS ) after tactile ( blunt tipped probe ) , thermal ( air blast ) and osmotic ( water blast ) stimulus at time intervals of baseline , 7 , 15 and 30 days .
RESULTS	The greatest reductions in DH were observed for the TG , with significant differences for FG in the thermal ( = -56 vs -30 ) and osmotic stimuli ( = -44 vs -18 ) .
RESULTS	Considering the percentage of participants with moderate/severe pain at 30 days , the TG demonstrated the lowest percentages , with significant differences in comparison with the other groups in thermal and osmotic stimuli .
RESULTS	We can conclude that the test gel showed a greater reduction in DH than fluoride 2 % and placebo gel , and maybe a treatment option for individuals with DH .

###25046787
BACKGROUND	Morbidly obese patients are at high risk for perioperative complications , including surgical site infections .
BACKGROUND	Baseline arterial oxygenation is low in the morbidly obese , leading to low tissue oxygenation , which in turn is a primary determinant of infection risk .
BACKGROUND	We therefore tested the hypothesis that extending intraoperative supplemental oxygen 12 to 16 hours into the postoperative period reduces the risk of surgical site infection and healing-related complications .
METHODS	Morbidly obese patients having open or laparoscopic bariatric surgery were given 80 % inspired oxygen intraoperatively .
METHODS	Postoperatively , patients were randomly assigned to either 2 L/min of oxygen via nasal cannula or approximately 80 % supplemental inspired oxygen after tracheal extubation until the first postoperative morning .
METHODS	The risks of surgical site infection and of major healing-related complications were evaluated 60 days after surgery .
RESULTS	In a preplanned interim analysis based on the initial 400 patients , the overall observed incidence of the collapsed composite of major complications was 13.3 % ; the observed incidence of components of the composite outcome ranged from 0 % ( peritonitis ) to 8.5 % ( surgical wound infection ) .
RESULTS	The estimated relative risk of any 1 major complications occurring within the first 60 days after surgery , adjusting for study site , was 0.94 ( 95 % confidence interval , 0.52-1 .68 ) ( P = 0.80 , Cochran-Mantel-Haenszel ) .
RESULTS	The Executive Committee thus stopped the trial for futility .
CONCLUSIONS	Supplemental postoperative oxygen does not reduce the risk of surgical site infection rate and healing-related postoperative complications in patients having gastric bypass surgery .

###25661412
OBJECTIVE	To assess whether endotracheal suctioning of nonvigorous infants born through meconium stained amniotic fluid ( MSAF ) reduces the risk and complications of meconium aspiration syndrome ( MAS ) .
METHODS	Term , nonvigorous babies born through MSAF were randomized to endotracheal suction and no-suction groups ( n = 61 in each ) .
METHODS	Risk of MAS , complications of MAS and endotracheal suction , mortality , duration of neonatal intensive care unit stay , and neurodevelopmental outcome at 9 months were assessed .
RESULTS	Maternal age , consistency of meconium , mode of delivery , birth weight , sex , and Apgar scores were similar in the groups .
RESULTS	In total , 39 ( 32 % ) neonates developed MAS and 18 ( 14.8 % ) of them died .
RESULTS	There were no significant differences in MAS , its severity and complications , mortality , and neurodevelopmental outcome for the 2 groups .
RESULTS	One infant had a complication of endotracheal suctioning , which was mild and transient .
CONCLUSIONS	The current practice of routine endotracheal suctioning for nonvigorous neonates born through MSAF should be further evaluated .
BACKGROUND	Clinical Trial Registry of India : CTRI/2013/03 / 003469 .

###25294589
BACKGROUND	This phase 3 trial compared the safety and efficacy of edoxaban , an oral direct factor Xa inhibitor , with enoxaparin sodium ( enoxaparin ) for thromboprophylaxis after total knee arthroplasty ( TKA ) in patients in Japan and Taiwan .
METHODS	In this randomized , double-blind , double-dummy study , patients received oral edoxaban 30 mg once daily beginning 6 to 24 hours postsurgery or enoxaparin 2000 IU ( equivalent to 20 mg ) subcutaneously twice daily beginning 24 to 36 hours postsurgery for 11 to 14 days .
METHODS	The primary efficacy endpoint was the composite of symptomatic pulmonary embolism and symptomatic and asymptomatic deep vein thrombosis .
METHODS	Safety endpoints included the incidence of major bleeding , clinically relevant non-major ( CRNM ) bleeding , major bleeding or CRNM bleeding , all bleeding events , adverse events , and adverse drug reactions .
RESULTS	Of 716 patients enrolled , 360 and 356 were randomized to receive edoxaban or enoxaparin , respectively .
RESULTS	The primary efficacy outcome occurred in 22/299 ( 7.4 % ) and 41/295 ( 13.9 % ) patients in the edoxaban and enoxaparin groups , respectively ( relative risk reduction = 46.8 % ) , indicating non-inferiority ( P < 0.001 ) and superiority ( P = 0.010 ) of edoxaban versus enoxaparin .
RESULTS	In the edoxaban and enoxaparin groups , major bleeding occurred in 4/354 ( 1.1 % ) versus 1/349 ( 0.3 % ) patients ( P = 0.373 ) ; major or CRNM bleeding occurred in 22/354 ( 6.2 % ) versus 13/349 ( 3.7 % ) patients ( P = 0.129 ) , respectively .
CONCLUSIONS	Edoxaban 30 mg once daily was more effective for thromboprophylaxis than subcutaneous enoxaparin 2000 IU twice daily following TKA and demonstrated a similar incidence of bleeding events .

###25282309
BACKGROUND	Some chronic pain patients receiving long-term opioid analgesic pharmacotherapy are at risk for misusing opioids .
BACKGROUND	Like other addictive behaviors , risk of opioid misuse may be signaled by an attentional bias ( AB ) towards drug-related cues .
BACKGROUND	The purpose of this study was to examine opioid AB as a potential predictor of opioid misuse among chronic pain patients following behavioral treatment .
METHODS	Chronic pain patients taking long-term opioid analgesics ( n = 47 ) completed a dot probe task designed to assess opioid AB , as well as self-report measures of opioid misuse and pain severity , and then participated in behavioral treatment .
METHODS	Regression analyses examined opioid AB and cue-elicited craving as predictors of opioid misuse at 3-month posttreatment follow-up .
RESULTS	Patients who scored high on a measure of opioid misuse risk following treatment exhibited significantly greater opioid AB scores than patients at low risk for opioid misuse .
RESULTS	Opioid AB for 200 ms cues and cue-elicited craving significantly predicted opioid misuse risk 20 weeks later , even after controlling for pre-treatment opioid dependence diagnosis , opioid misuse , and pain severity ( Model R ( 2 ) = .50 ) .
CONCLUSIONS	Biased initial attentional orienting to prescription opioid cues and cue-elicited craving may reliably signal future opioid misuse risk following treatment .
CONCLUSIONS	These measures may therefore provide potential prognostic indicators of treatment outcome .

###24430534
BACKGROUND	This analysis assessed changes in serum 25-hydroxyvitamin D ( 25 [ OH ] D ; the precursor form of active vitamin D ) in antiretroviral-naive adults receiving rilpivirine or efavirenz over 48 weeks in a randomized , double-blind , Phase III trial ( ECHO ) .
METHODS	ECHO included 690 patients randomized 1:1 to receive rilpivirine 25 mg once daily ( n = 346 ) or efavirenz 600 mg once daily ( n = 344 ) , plus tenofovir disoproxil fumarate/emtricitabine .
METHODS	25 ( OH ) D was measured in stored serum samples collected at baseline , and weeks 24 and 48 .
METHODS	Proportions of patients with optimal/sufficient ( 30 ng/ml ) , insufficient ( 21-29 ng/ml ) , deficient ( 10-20 ng/ml ) and severely deficient ( < 10 ng/ml ) 25 ( OH ) D levels were determined .
METHODS	Data are presented for patients with paired baseline and week 48 25 ( OH ) D data ( rilpivirine , n = 292 ; efavirenz , n = 290 ) .
RESULTS	After 48 weeks , mean 25 ( OH ) D levels remained largely unchanged from baseline with rilpivirine ( -0.2 ng/ml ; P = 0.57 versus no change ) , but were significantly reduced with efavirenz ( -2.5 ng/ml ; P < 0.0001 versus no change ) .
RESULTS	When adjusting for season of randomization and the combined variable of race ( Black/African American , White/Caucasian , Asian , other race ) and ethnicity ( Hispanic or Latino and not Hispanic or not Latino ) , the conclusion about the treatment difference between the rilpivirine and efavirenz treatment groups remained valid .
RESULTS	At baseline the proportion of patients with severe 25 ( OH ) D deficiency was similar in both groups ( 5 % ) but was significantly lower with rilpivirine than efavirenz at week 48 ( 5 % versus 9 % , respectively ; P = 0.032 ) .
RESULTS	Furthermore , of the patients with 25 ( OH ) D insufficiency/deficiency at baseline , the proportion who developed severe 25 ( OH ) D deficiency at week 48 was significantly lower with rilpivirine than efavirenz ( 2 % versus 8 % , respectively ; P = 0.0079 ) .
CONCLUSIONS	Rilpivirine had little effect on 25 ( OH ) D , whereas efavirenz resulted in a significant reduction in 25 ( OH ) D levels and an increase in the risk of severe 25 ( OH ) D deficiency .

###24566753
OBJECTIVE	This study aimed to investigate the effects of a 6-month preventive resistance training program on resting metabolic rate ( RMR ) and its associations with fat-free mass ( FFM ) and the newly described myokine irisin as two potential mechanistic links between exercise training and RMR .
METHODS	In a randomized controlled trial , 74 sedentary healthy male and female participants either completed 6 months of high-repetition resistance training 3 dwk in accordance with the American College of Sports Medicine recommendations ( RT : n = 37 ; 47 7 yr ; body mass index , 25.0 3.4 kgm ) or served as controls ( CO : n = 37 ; 50 7 yr ; body mass index , 24.2 3.2 kgm ) .
METHODS	Strength ( one-repetition maximum ) , RMR ( indirect calorimetry ) , body fat ( caliper method ) , and serum irisin concentration ( enzyme-linked immunosorbent assay ) were measured before and after 6 months of training .
RESULTS	Training led to an increase in strength ( one-repetition maximum leg press , 16 % 7 % ; P < 0.001 ) .
RESULTS	RMR increased in RT ( 1671 356 vs 1843 385 kcald , P < 0.001 ) but not in CO ( 1587 285 vs 1602 294 kcald , P = 0.97 ; group-time interaction , P < 0.01 ) .
RESULTS	Body weight ( RT , -0.5 2.4 kg ; CO , 0.1 2.3 kg ) , body fat percentage ( RT , -1.1 % 2.5 % ; CO , -0.7 % 2.9 % ) , and FFM ( RT , 0.4 2.1 kg ; CO , 0.6 1.9 kg ) did not develop differently between groups ( group-time interaction : P = 0.29 , P = 0.54 , and P = 0.59 , respectively ) .
RESULTS	Serum irisin concentration increased in CO ( 70.8 83.4 ngmL , P < 0.001 ) but not in RT ( 22.4 92.6 ngmL , P = 0.67 ; group-time interaction , P < 0.01 ) .
RESULTS	The change in RMR was not associated with the change in FFM ( r = -0.11 , P = 0.36 ) or irisin ( r = -0.004 , P = 0.97 ) .
CONCLUSIONS	Preventive resistance training elicits an increase in RMR .
CONCLUSIONS	However , in contrast to currently discussed hypotheses , this increase does not seem to be mediated by training-induced changes in FFM or circulating irisin concentration , which casts doubt in the meaning of irisin for human energy balance .

###25230593
BACKGROUND	Despite rapid dissemination of an everolimus-eluting bioresorbable scaffold for treatment for coronary artery disease , no data from comparisons with its metallic stent counterpart are available .
BACKGROUND	In a randomised controlled trial we aimed to compare an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent .
BACKGROUND	Here we report secondary clinical and procedural outcomes after 1 year of follow-up .
METHODS	In a single-blind , multicentre , randomised trial , we enrolled eligible patients aged 18-85 years with evidence of myocardial ischaemia and one or two de-novo native lesions in different epicardial vessels .
METHODS	We randomly assigned patients in a 2:1 ratio to receive treatment with an everolimus-eluting bioresorbable scaffold ( Absorb , Abbott Vascular , Santa Clara , CA , USA ) or treatment with an everolimus-eluting metallic stent ( Xience , Abbott Vascular , Santa Clara , CA , USA ) .
METHODS	Randomisation was stratified by diabetes status and number of planned target lesions .
METHODS	The co-primary endpoints of this study are vasomotion ( change in mean lumen diameter before and after nitrate administration at 3 years ) and difference between minimum lumen diameter ( after nitrate administration ) after the index procedure and at 3 years .
METHODS	Secondary endpoints were procedural performance assessed by quantitative angiography and intravascular ultrasound ; composite clinical endpoints based on death , myocardial infarction , and coronary revascularisation ; device and procedural success ; and angina status assessed by the Seattle Angina Questionnaire and exercise testing at 6 and 12 months .
METHODS	Cumulative angina rate based on adverse event reporting was analysed post hoc .
METHODS	This trial is registered at ClinicalTrials.gov , number NCT01425281 .
RESULTS	Between Nov 28 , 2011 , and June 4 , 2013 , we enrolled 501 patients and randomly assigned them to the bioresorbable scaffold group ( 335 patients , 364 lesions ) or the metallic stent group ( 166 patients , 182 lesions ) .
RESULTS	Dilatation pressure and balloon diameter at the highest pressure during implantation or postdilatation were higher and larger in the metallic stent group , whereas the acute recoil post implantation was similar ( 0.19 mm for both , p = 0.85 ) .
RESULTS	Acute lumen gain was lower for the bioresorbable scaffold by quantitative coronary angiography ( 1.15 mm vs 1.46 mm , p < 0.0001 ) and quantitative intravascular ultrasound ( 2.85 mm ( 2 ) vs 3.60 mm ( 2 ) , p < 0.0001 ) , resulting in a smaller lumen diameter or area post procedure .
RESULTS	At 1 year , however , cumulative rates of first new or worsening angina from adverse event reporting were lower ( 72 patients [ 22 % ] in the bioresorbable scaffold group vs 50 [ 30 % ] in the metallic stent group , p = 0.04 ) , whereas performance during maximum exercise and angina status by SAQ were similar .
RESULTS	The 1-year composite device orientated endpoint was similar between the bioresorbable scaffold and metallic stent groups ( 16 patients [ 5 % ] vs five patients [ 3 % ] , p = 0.35 ) .
RESULTS	Three patients in the bioresorbable scaffold group had definite or probable scaffold thromboses ( one definite acute , one definite sub-acute , and one probable late ) , compared with no patients in the metallic stent group .
RESULTS	There were 17 ( 5 % ) major cardiac adverse events in the bioresorbable scaffold group compared with five ( 3 % ) events in the metallic stent group , with the most common adverse events being myocardial infarction ( 15 cases [ 4 % ] vs two cases [ 1 % ] , respectively ) and clinically indicated target-lesion revascularisation ( four cases [ 1 % ] vs three cases [ 2 % ] , respectively ) .
CONCLUSIONS	The everolimus-eluting bioresorbable scaffold showed similar 1-year composite secondary clinical outcomes to the everolimus-eluting metallic stent .
BACKGROUND	Abbott Vascular .

###24866594
OBJECTIVE	Although sleep has been shown to enhance motor skill learning , it remains unclear whether sleep enhances learning of a functional motor task in middle-aged and older individuals .
OBJECTIVE	The purpose of this study was to examine whether sleep enhances motor learning of a functional motor task in middle-aged and older adults .
METHODS	Twenty middle-aged and 20 older individuals were randomly assigned to either the sleep condition or the no-sleep condition .
METHODS	Participants in the sleep condition practiced a novel walking task in the evening , and returned the following morning for retesting .
METHODS	Participants in the no-sleep condition practiced the walking task in the morning and returned the same day in the evening for a retest .
METHODS	Outcome measures included time around the walking path and spatiotemporal gait parameters .
RESULTS	Only the middle-aged and older adults in the sleep condition demonstrated significant off-line improvement in performance , measured as a decline in time to walk around the novel path and improvement in spatiotemporal gait parameters .
RESULTS	The middle-aged and older adults in the no-sleep condition failed to demonstrate off-line improvements in performance of this functional task .
CONCLUSIONS	This is the first study to provide evidence that sleep facilitates learning a clinically relevant functional motor task in middle-aged and older adults .
CONCLUSIONS	Because many neurologic conditions occur in the middle-aged and older adults and sleep issues are very prevalent in many neurologic conditions , it is imperative that physical therapists consider sleep as a factor that may impact motor learning and recovery in these individuals .
BACKGROUND	( See Video , Supplemental Digital Content 1 , http://links.lww.com/JNPT/A73 ) for more insights from the authors .

###24844389
BACKGROUND	The presence of an adequate zone of keratinized tissue has been associated with implant health .
BACKGROUND	This study evaluated the increasing of the zone of keratinized tissue using dense polytetrafluoroethylene ( d-PTFE ) membranes over extraction sites , without primary closure .
METHODS	Fifteen sites received d-PTFE membranes .
METHODS	The control sites received no membranes .
METHODS	All cases were sutured with no attempt to achieve primary closure .
METHODS	Before surgery , initial measurements of buccal and lingual keratinized tissue were taken from the mucogingival line ( MGL ) to the most coronal gingival margins .
METHODS	Final measurements were taken from the buccal MGL to the lingual MGL , 60 and 90 days after extractions .
RESULTS	In the test group , a mean increase in the zone of keratinized tissue of 7.06 2.63 mm and 6.6 2.84 mm was observed in 60 and 90 days , respectively .
RESULTS	In the control group , a mean increase of 2.46 1.59 mm and 1.40 1.40 mm was observed in 60 and 90 days , respectively .
CONCLUSIONS	Nonexpanded d-PTFE membranes can predictably be used to increase the zone of keratinized tissue in preparation to implant placement .

###25486415
OBJECTIVE	To investigate the impact of tuberculosis-associated immune reconstitution inflammatory syndrome ( TB-IRIS ) upon immunological recovery and the T-cell compartment after initiation of TB and antiretroviral therapy ( ART ) .
METHODS	We prospectively evaluated T-cell immunophenotypes by flow cytometry and cytokines by Luminex assays in a subset ( n = 154 ) of highly immunosuppressed HIV-infected patients with TB from the Cambodian Early versus Late Introduction of Antiretrovirals randomized clinical trial .
METHODS	We compared findings from patients who developed TB-IRIS with findings from patients who did not develop TB-IRIS .
METHODS	Data were evaluated with mixed-effect linear regression , Kaplan-Meier estimates , and Wilcoxon rank-sum tests , and q-values were calculated to control for multiple comparisons .
RESULTS	Development of TB-IRIS was associated with significantly greater pre-ART frequencies of HLA-DRCD45ROCD4 , CCR5CD4 , OX40CD4 , and Fas effector memory CD8 T cells , and significantly elevated levels of plasma interleukin ( IL ) -6 , IL-1 , IL-8 , and IL-10 , and viral load .
RESULTS	Post-ART initiation , effector memory CD4 and Fas effector memory CD4 T-cell frequencies significantly expanded , and central memory CD4 T-cell frequencies significantly contracted in patients who experienced TB-IRIS .
RESULTS	By week 34 post-TB treatment initiation , effector memory/central memory CD4 T-cell ratios were markedly higher in TB-IRIS versus non-TB-IRIS patients .
CONCLUSIONS	A distinct pattern of pre-ART T-cell and cytokine markers appear to poise the immune response of certain patients to develop TB-IRIS .
CONCLUSIONS	Experience of TB-IRIS is then associated with long-term remodeling of the CD4 T-cell memory compartment towards an effector memory-dominated phenotype .
CONCLUSIONS	We speculate that these pre and post-ART TB-IRIS-associated immune parameters may contribute to superior immune control of TB/HIV co-infection and better clinical outcome .

###25649150
BACKGROUND	Frequent handwashing can prevent infections , but non-compliance to hand hygiene is pervasive .
BACKGROUND	Few theory - and evidence-based interventions to improve regular handwashing are available .
BACKGROUND	Therefore , two intervention modules , a motivational and a self-regulatory one , were designed and evaluated .
METHODS	In a longitudinal study , 205 young adults , aged 18 to 26 years , were randomized into two intervention groups .
METHODS	The Mot-SelfR group received first a motivational intervention ( Mot ; risk perception and outcome expectancies ) followed by a self-regulatory intervention ( SelfR ; perceived self-efficacy and planning ) 17 days later .
METHODS	The SelfR-Mot group received the same two intervention modules in the opposite order .
METHODS	Follow-up data were assessed 17 and 34 days after the baseline .
RESULTS	Both intervention sequences led to an increase in handwashing frequency , intention , self-efficacy , and planning .
RESULTS	Also , overall gains were found for the self-regulatory module ( increased planning and self-efficacy levels ) and the motivational module ( intention ) .
RESULTS	Within groups , the self-regulatory module appeared to be more effective than the motivational module , independent of sequence .
CONCLUSIONS	Self-regulatory interventions can help individuals to exhibit more handwashing .
CONCLUSIONS	Sequencing may be important as a motivation module ( Mot ) first helps to set the goal and a self-regulatory module ( SelfR ) then helps to translate this goal into actual behavior , but further research is needed to evaluate mechanisms .

###24768938
OBJECTIVE	The primary goal of Phase II clinical trials is to understand better a treatment 's safety and efficacy to inform a Phase III go/no-go decision .
OBJECTIVE	Many Phase II designs have been proposed , incorporating randomization , interim analyses , adaptation , and patient selection .
OBJECTIVE	The Phase II design with an option for direct assignment ( i.e. stop randomization and assign all patients to the experimental arm based on a single interim analysis ( IA ) at 50 % accrual ) was recently proposed [ An et al. , 2012 ] .
OBJECTIVE	We discuss this design in the context of existing designs , and extend it from a single-IA to a two-IA design .
METHODS	We compared the statistical properties and clinical relevance of the direct assignment design with two IA ( DAD-2 ) versus a balanced randomized design with two IA ( BRD-2 ) and a direct assignment design with one IA ( DAD-1 ) , over a range of response rate ratios ( 2.0-3 .0 ) .
RESULTS	The DAD-2 has minimal loss in power ( < 2.2 % ) and minimal increase in T1ER ( < 1.6 % ) compared to a BRD-2 .
RESULTS	As many as 80 % more patients were treated with experimental vs. control in the DAD-2 than with the BRD-2 ( experimental vs. control ratio : 1.8 vs. 1.0 ) , and as many as 64 % more in the DAD-2 than with the DAD-1 ( 1.8 vs. 1.1 ) .
RESULTS	We illustrate the DAD-2 using a case study in lung cancer .
CONCLUSIONS	In the spectrum of Phase II designs , the direct assignment design , especially with two IA , provides a middle ground with desirable statistical properties and likely appeal to both clinicians and patients .

###24902814
BACKGROUND	The success of laparoscopic surgery is due to the less surgical trauma , including less operative pain , complications and better cosmetics .
BACKGROUND	Objective of our study was to compare in two blind randomized groups of patients , the surgical outcome of total extra-peritoneal ( TEP ) inguinal hernia repair using either single-port or conventional surgical technique .
BACKGROUND	We will report our interim results in the first group of 50 patients .
METHODS	Our study is a prospective , randomized , controlled clinical trial conducted from August 2011 to June 2013 .
METHODS	Fifty patients aged between 21 and 80 years undergoing surgery for unilateral inguinal hernia were randomised into two groups : conventional laparoscopic TEP inguinal hernia repair versus single-port TEP repair .
METHODS	Clinical data on patient demographics , surgical technique and findings , postoperative complications and pain scores were collected .
METHODS	Primary endpoint is the postoperative pain while secondary endpoints are recurrence , chronic pain , postoperative hospital stay and complications .
RESULTS	Out of the 50 patients , 26 underwent single-port hernia TEP repair and 24 had conventional 3-port TEP hernia repair after randomization .
RESULTS	Mean operative time was 51.7 ( 13.4 ) min in the multiport group and 59.3 ( 14.9 ) min in the single-port group , respectively ( P = 0.064 ) .
RESULTS	Mean hospital stay was 19.7 ( 4.8 ) h in the conventional group and 22.1 ( 4.5 ) h in the single-port group ( P = 0.079 ) .
RESULTS	No statistically significant differences were observed between the two groups for postoperative complications , and no recurrence reported at 11 months follow-up .
RESULTS	There was no significant difference in the pain scores ( visual analog scale ) between the two groups at regular intervals post surgery .
CONCLUSIONS	The outcomes after laparoscopic TEP inguinal hernia repair with a single-port device are comparable to the standard three-port technique .

###24649785
BACKGROUND	Post-dural puncture headache ( PDPH ) is the most frequent complication of procedures associated with dural puncture for spinal anesthesia or following accidental dural puncture during epidural anesthesia .
BACKGROUND	Since invasive treatments have known complications , pharmacologic management may be preferable .
BACKGROUND	The aim of this study was to evaluate and compare the efficacy of theophylline and Acetaminophen in treatment of PDPH .
METHODS	In this single-blind randomized clinical trial , 60 patients with Class I physical status according to ASA classification system , who suffered from PDPH were enrolled .
METHODS	Patients in Theophylline group were received theophylline tablet 250 mg three times per day , and in the other group acetaminophen 500 mg three times per day was administered .
METHODS	Pain intensity was assessed 2 , 6 , and 12 hour after drug administration using 0-10 cm Visual Analog Scale .
RESULTS	The main VAS values is significantly lower in theophylline group in comparison with the acetaminophen group at 2 ( 5 + / - 1.57 vs. 5.97 + / - 1.27 ) , 6 ( 3.43 + / - 1.73 vs. 4.33 + / - 1.49 ) , and 12 ( 2.67 + / - 2.35 vs. 4.24 + / - 1.97 ) hours after drug administration ( p < 0.05 ) .
RESULTS	No adverse effects were reported .
CONCLUSIONS	Theophylline is a safe and effective treatment for PDPH .
CONCLUSIONS	It may be tried in PDPH patients before using any invasive technique .
CONCLUSIONS	Further investigations studying other Methylxanthines are recommended as well .

###25775634
BACKGROUND	There is currently a lack of evidence-based therapies that are safe and effective for plaque-type morphea .
BACKGROUND	We aimed to evaluate the therapeutic potential and safety profile of imiquimod 5 % cream in plaque-type morphea .
METHODS	We enrolled 25 adult patients from two Canadian centers with histologically confirmed plaque-type morphea .
METHODS	Imiquimod 5 % was applied to a representative plaque , and vehicle was applied to a control plaque for 9 months .
METHODS	Treatment efficacy was assessed with the Dyspigmentation , Induration , Erythema , and Telangiectasias ( DIET ) score , histology , and ultrasound evaluation .
CONCLUSIONS	Twenty-two patients completed the entire length of the study .
CONCLUSIONS	Imiquimod 5 % was superior to vehicle in reducing DIET scores at 3 , 6 , 9 , and 12 months ( p < .05 ) .
CONCLUSIONS	Induration demonstrated the greatest response .
CONCLUSIONS	Histologic evaluation showed significant improvement or resolution of disease .
CONCLUSIONS	However , no ultrasonographic differences were found in dermal and hypodermal thicknesses between the treatment and vehicle groups ( p > .05 ) .
CONCLUSIONS	Adverse effects were minimal and well tolerated .

###25014001
BACKGROUND	Recent observational studies have suggested that the use of selective serotonin reuptake inhibitors is associated with an increased fracture risk and an accelerated bone loss , although conflicting results have been reported .
BACKGROUND	Furthermore , because many of these studies have been performed in depressed women , confounding by indication may influence these findings .
OBJECTIVE	The objective of the study was to determine whether selective serotonin reuptake inhibitors affect bone metabolism Design : This was a randomized controlled trial .
METHODS	The study was conducted in four US clinical sites .
METHODS	Healthy peri - and postmenopausal women participated in the study .
METHODS	The intervention was escitalopram ( 10-20 mg/d ) for the treatment of vasomotor symptoms .
METHODS	Serum carboxyterminal collagen crosslinks ( CTX ) and serum amino-terminal propeptide of type I collagen ( P1NP ) were measured .
RESULTS	One hundred forty-one peri - or postmenopausal nondepressed women ( mean age 53.7 y , SD 4.1 ) had baseline and 8-week follow-up samples available for analysis and were included in the study ( 69 escitalopram , 72 placebo ) .
RESULTS	The groups were balanced across a broad range of baseline characteristics , including age , race , body mass index , smoking status , and mood symptoms .
RESULTS	The between-group differences in the change in CTX and P1NP from baseline to week 8 were compared by a repeated-measures linear regression model adjusted for race , clinical center , and baseline measurement .
RESULTS	Treatment with escitalopram reduced serum P1NP by 1.02 ng/mL on average [ 95 % confidence interval ( CI ) -5.17 , 3.12 ] compared with a reduction of 1.88 ng/mL ( 95 % CI -4.82 , 1.06 ) in the placebo group ( P = .65 ) .
RESULTS	Similarly , serum CTX decreased 0.02 ng/mL on average ( 95 % CI -0.05 , 0.01 ) in the escitalopram group compared with 0.00 ng/mL ( 95 % CI -0.02 , 0.02 ) in the placebo group ( P = .24 ) .
RESULTS	The results were similar when the analysis was restricted to those women whose adherence to study medication was 70 % or greater .
CONCLUSIONS	Although the study was limited to 8 weeks , these results suggest that escitalopram does not significantly alter bone metabolism in the short term .

###24429175
OBJECTIVE	To evaluate the longer-term safety and efficacy of secukinumab , a fully human monoclonal antiinterleukin-17A antibody , in patients with rheumatoid arthritis .
METHODS	In this 52-week , double-blind , placebo-controlled ( up to Week 20 ) study ( NCT00928512 ) , patients responding inadequately to disease-modifying antirheumatic drugs ( DMARD ) or biologics were randomized to receive monthly subcutaneous injections of secukinumab ( 25 , 75 , 150 , or 300 mg ) , or placebo .
METHODS	The efficacy and safety results up to Week 20 have been reported previously .
METHODS	Here , efficacy results from Week 20 to 52 and safety results from Week 20 to 60 are presented .
RESULTS	Of 237 patients randomized , 174 ( 73.4 % ) completed the study .
RESULTS	Patients with improved American College of Rheumatology ( ACR ) and 28-joint Disease Activity Score ( DAS28 ) C-reactive protein ( CRP ) responses at Week 16 sustained their responses through Week 52 .
RESULTS	In patients taking 150 mg of secukinumab , responses were improved through Week 52 ( ACR50 : Week 16 = 45 % , Week 52 = 55 % ; DAS28-CRP 2.6 : Week 16 = 25 % , Week 52 = 40 % ) .
RESULTS	The rate of adverse events ( AE ) from weeks 20 to 60 was 64.8 % , with most AE being mild to moderate in severity .
RESULTS	The overall rate of infections was 31.9 % , most being mild .
RESULTS	The most predominant infection was nasopharyngitis , and was not associated with dose or concurrent neutropenia .
RESULTS	Serious AE were reported in 21 patients ( 8.9 % ) .
RESULTS	There were 3 reports of malignancies ( ovarian , lung , basal cell ) , and no deaths between weeks 20 and 60 .
CONCLUSIONS	Patients with active RA who failed to respond to DMARD and other biologics showed an improvement after longterm treatment with 150 mg of secukinumab .
CONCLUSIONS	The frequency of AE remained stable over time and secukinumab had a consistent safety profile over 60 weeks .

###24864592
OBJECTIVE	To compare the efficacy of ondansetron alone and combination of ondansetron and dexamethasone in preventing post-operative nausea and vomiting in patients undergoing laparoscopic cholecystectomy .
METHODS	The randomised control trial was conducted from April 23 to August 22 , 2009 , at the Liaquat National Hospital , Karachi , and comprised 100 American Society of Anaesthesiology I and II patients undergoing laparoscopic cholecystectomy .
METHODS	Half of the subjects comprised Group A and received ondansetron alone , while Group B received combination of ondansetron and dexamethasone .
METHODS	They were randomised by opaque envelope method .
METHODS	Group A received ondansetron 4 mg while Group B received ondansetron 4 mg with dexamethasone 8 mg , 1 minute before induction .
METHODS	Post-operatively patients were observed for six hours for any episode of nausea or vomiting , or whether the patients required any rescue anti emetic .
METHODS	SPSS 19 was used for statistical analysis .
RESULTS	Patients receiving ondansetron alone showed 14 ( 28 % ) with incidence of nausea or vomiting while the other group showed 6 ( 12 % ) .
RESULTS	This difference was statistically significant ( p < 0.046 ) .
CONCLUSIONS	Combination of ondansetron and dexamethasone was more efficacious compared to ondansetron alone in the prevention of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy .

###24731416
OBJECTIVE	To explore the long-term effects of the uvulopalatopharyngoplasty ( UPPP ) combined with oral appliance ( OA ) in the treatment of obstructive sleep apnea hypopnea syndrome ( OSAHS ) .
METHODS	Thirty patients with severe OSAHS confirmed by polysomnography ( PSG ) according to their apnea hypopnea index ( AHI ) and lowest SaO2 during sleep were selected using random permutation table and divided into only UPPP group ( U group , n = 15 ) and UPPP with OA group ( UA group , n = 15 ) .
METHODS	The follow-up period was 2 years .
METHODS	PSG was performed in 0.5 year and 2 years after operation .
METHODS	AHI , lowest SaO2 and Tmax were tested and evaluated .
RESULTS	The effectiveness of two groups was the same after 0.5 year .
RESULTS	Two years after operation , the values [ AHI : ( 18.06 2.24 ) times/h ; lowest SaO2 : ( 88.64 10.37 ) % and Tmax : ( 20.5 17.6 ) s ] in UA group were better than that [ AHI : ( 49.73 3.35 ) times/h ; lowest SaO2 : ( 79.56 4.87 ) % and Tmax : ( 41.3 19.7 ) s ] in U group .
RESULTS	The number of effectiveness was 9 and the number of ineffectiveness was 6 in U group , while in UA group , the number of effectiveness was 14 and the number of ineffectiveness was 1 ( P < 0.05 ) .
CONCLUSIONS	Long-term result of combined treatment was better than that of UPPP only .

###24970601
BACKGROUND	Cognitive behavioral therapy ( CBT ) is an effective treatment for panic disorder with agoraphobia ( PD/AG ) .
BACKGROUND	It is unknown , how variants of CBT differentially modulate brain networks involved in PD/AG .
BACKGROUND	This study was aimed to evaluate the effects of therapist-guided ( T + ) versus self-guided ( T - ) exposure on the neural correlates of fear conditioning in PD/AG .
METHODS	In a randomized , controlled multicenter clinical trial in medication-free patients with PD/AG who were treated with 12 sessions of manualized CBT , functional magnetic resonance imaging ( fMRI ) was used during fear conditioning before ( t1 ) and after CBT ( t2 ) .
METHODS	Quality-controlled fMRI data from 42 patients and 42 healthy subjects ( HS ) were obtained .
METHODS	Patients were randomized to two variants of CBT ( T + , n = 22 , and T - , n = 20 ) .
RESULTS	The interaction of diagnosis ( PD/AG , HS ) , treatment group ( T + , T - ) , time point ( t1 , t2 ) and stimulus type ( conditioned stimulus : yes , no ) revealed activation in the left hippocampus and the occipitotemporal cortex .
RESULTS	The T + group demonstrated increased activation of the hippocampus at t2 ( t2 > t1 ) , which was positively correlated with treatment outcome , and a decreased connectivity between the left inferior frontal gyrus and the left hippocampus across time ( t1 > t2 ) .
CONCLUSIONS	After T + exposure , contingency-encoding processes related to the posterior hippocampus are augmented and more decoupled from processes of the left inferior frontal gyrus , previously shown to be dysfunctionally activated in PD/AG .
CONCLUSIONS	Linking single procedural variants to neural substrates offers the potential to inform about the optimization of targeted psychotherapeutic interventions .

###24824288
OBJECTIVE	Early nutrition influences metabolic programming and long-term health .
OBJECTIVE	We explored the urinary metabolite profiles of 48 premature infants ( birth weight < 1500 g ) randomized to an enhanced or a standard diet during neonatal hospitalization .
METHODS	Metabolomics using nuclear magnetic resonance spectroscopy ( NMR ) was conducted on urine samples obtained during the first week of life and thereafter fortnightly .
RESULTS	The intervention group received significantly higher amounts of energy , protein , lipids , vitamin A , arachidonic acid and docosahexaenoic acid as compared to the control group .
RESULTS	Enhanced nutrition did not appear to affect the urine profiles to an extent exceeding individual variation .
RESULTS	However , in all infants the glucogenic amino acids glycine , threonine , hydroxyproline and tyrosine increased substantially during the early postnatal period , along with metabolites of the tricarboxylic acid cycle ( succinate , oxoglutarate , fumarate and citrate ) .
RESULTS	The metabolite changes correlated with postmenstrual age .
RESULTS	Moreover , we observed elevated threonine and glycine levels in first-week urine samples of the small for gestational age ( SGA ; birth weight < 10th percentile for gestational age ) as compared to the appropriate for gestational age infants .
CONCLUSIONS	This first nutri-metabolomics study in premature infants demonstrates that the physiological adaptation during the fetal-postnatal transition as well as maturation influences metabolism during the breastfeeding period .
CONCLUSIONS	Elevated glycine and threonine levels were found in the first week urine samples of the SGA infants and emerged as potential biomarkers of an altered metabolic phenotype .

###24848284
OBJECTIVE	This study evaluated the efficacy and tolerability of tapentadol extended release ( ER ) for the management of chronic pain associated with diabetic peripheral neuropathy ( DPN ) .
METHODS	Adults with moderate to severe DPN pain were titrated to tapentadol ER 100-250 mg bid during a 3-week open-label period ; patients with 1-point reduction in pain intensity ( 11-point numerical rating scale ) at end of titration were randomized to receive placebo or tapentadol ER ( optimal dose from titration ) for 12 weeks ( double-blind , fixed-dose maintenance phase ) .
METHODS	The primary end point was mean change in average pain intensity from the start to week 12 ( last observation carried forward [ LOCF ] ) of the double-blind maintenance phase .
RESULTS	A total of 358 patients completed the titration period ; 318 patients ( placebo , n = 152 ; tapentadol ER , n = 166 ) were randomized and received one or more doses of double-blind study medication .
RESULTS	Mean ( SD ) pain intensity ( observed case ) was 7.33 ( 1.30 ) at the start and 4.16 ( 2.12 ) at week 3 of the open-label titration period ( mean [ SD ] change , -3.22 [ 1.97 ] ) .
RESULTS	The mean ( SD ) change in pain intensity ( LOCF ) from start of double-blind treatment to week 12 was as follows : placebo , 1.30 ( 2.43 ) ; tapentadol ER , 0.28 ( 2.04 ; least squares mean difference , -0.95 [ 95 % CI -1.42 to -0.49 ] ; P < 0.001 ) .
RESULTS	Treatment-emergent adverse events ( 10 % ) in the tapentadol ER group during the double-blind maintenance phase were nausea ( 21.1 % ) and vomiting ( 12.7 % ) .
CONCLUSIONS	Tapentadol ER ( 100-250 mg bid ) was effective and well tolerated for the management of moderate to severe chronic pain associated with DPN .

###25671254
BACKGROUND	Lenvatinib , an oral inhibitor of vascular endothelial growth factor receptors 1 , 2 , and 3 , fibroblast growth factor receptors 1 through 4 , platelet-derived growth factor receptor , RET , and KIT , showed clinical activity in a phase 2 study involving patients with differentiated thyroid cancer that was refractory to radioiodine ( iodine-131 ) .
METHODS	In our phase 3 , randomized , double-blind , multicenter study involving patients with progressive thyroid cancer that was refractory to iodine-131 , we randomly assigned 261 patients to receive lenvatinib ( at a daily dose of 24 mg per day in 28-day cycles ) and 131 patients to receive placebo .
METHODS	At the time of disease progression , patients in the placebo group could receive open-label lenvatinib .
METHODS	The primary end point was progression-free survival .
METHODS	Secondary end points included the response rate , overall survival , and safety .
RESULTS	The median progression-free survival was 18.3 months in the lenvatinib group and 3.6 months in the placebo group ( hazard ratio for progression or death , 0.21 ; 99 % confidence interval , 0.14 to 0.31 ; P < 0.001 ) .
RESULTS	A progression-free survival benefit associated with lenvatinib was observed in all prespecified subgroups .
RESULTS	The response rate was 64.8 % in the lenvatinib group ( 4 complete responses and 165 partial responses ) and 1.5 % in the placebo group ( P < 0.001 ) .
RESULTS	The median overall survival was not reached in either group .
RESULTS	Treatment-related adverse effects of any grade , which occurred in more than 40 % of patients in the lenvatinib group , were hypertension ( in 67.8 % of the patients ) , diarrhea ( in 59.4 % ) , fatigue or asthenia ( in 59.0 % ) , decreased appetite ( in 50.2 % ) , decreased weight ( in 46.4 % ) , and nausea ( in 41.0 % ) .
RESULTS	Discontinuations of the study drug because of adverse effects occurred in 37 patients who received lenvatinib ( 14.2 % ) and 3 patients who received placebo ( 2.3 % ) .
RESULTS	In the lenvatinib group , 6 of 20 deaths that occurred during the treatment period were considered to be drug-related .
CONCLUSIONS	Lenvatinib , as compared with placebo , was associated with significant improvements in progression-free survival and the response rate among patients with iodine-131-refractory thyroid cancer .
CONCLUSIONS	Patients who received lenvatinib had more adverse effects .
CONCLUSIONS	( Funded by Eisai ; SELECT ClinicalTrials.gov number , NCT01321554 . )

###25146070
OBJECTIVE	To investigate the effect of spa adjuvant therapy on diabetic lower extremity arterial disease ( LEAD ) .
METHODS	128 patients with type II diabetes were separated into three groups according to the degree of lower extremity vascular stenosis .
METHODS	Patients within each group were then randomly divided to receive no treatment ( control ) or spa adjuvant therapy ( treatment ) .
METHODS	Clinical symptoms , blood pressure and hemodynamic analyses were compared between control and treatment groups by Chi square or t-test .
RESULTS	After adjuvant therapy with spa , patients ' pain , numbness , and cold sensation were significantly improved compared with control groups ( P < 0.05 ) .
RESULTS	Spa adjuvant therapy also significantly increased the dorsalis pedis pulse and systolic peak velocity ratio of patients with mild lower extremity vascular stenosis compared with control groups ( P < 0.05 ) , while there were no significant differences between the two groups for patients with moderate and severe stenosis ( P > 0.05 ) .
RESULTS	Both in the spa and control groups , there were no significant differences before and after medication for fasting , 2-h postprandial blood glucose and glycosylated hemoglobin ( HbA1C ) analyses ( P > 0.05 ) .
CONCLUSIONS	Spa adjuvant therapy can significantly alleviate lower extremity pain , numbness , and cold sensory symptoms in diabetic LEAD patients with stenosis .
CONCLUSIONS	Moreover , in LEAD patients with mild stenosis , spa adjuvant therapy also improves the dorsalis pedis pulse and systolic peak velocity ratio , suggesting a potential role for spa therapy as an early intervention strategy to treat the initial stages of disease .

###26061140
OBJECTIVE	A 12-month double-blind sham-surgery-controlled trial assessing adeno-associated virus type 2 ( AAV2 ) - neurturin injected into the putamen bilaterally failed to meet its primary endpoint , but showed positive results for the primary endpoint in the subgroup of subjects followed for 18 months and for several secondary endpoints .
OBJECTIVE	Analysis of postmortem tissue suggested impaired axonal transport of neurturin from putamen to substantia nigra .
OBJECTIVE	In the present study , we tested the safety and efficacy of AAV2-neurturin delivered to putamen and substantia nigra .
METHODS	We performed a 15 - to 24-month , multicenter , double-blind trial in patients with advanced Parkinson disease ( PD ) who were randomly assigned to receive bilateral AAV2-neurturin injected bilaterally into the substantia nigra ( 2.0 10 ( 11 ) vector genomes ) and putamen ( 1.0 10 ( 12 ) vector genomes ) or sham surgery .
METHODS	The primary endpoint was change from baseline to final visit performed at the time the last enrolled subject completed the 15-month evaluation in the motor subscore of the Unified Parkinson 's Disease Rating Scale in the practically defined off state .
RESULTS	Fifty-one patients were enrolled in the trial .
RESULTS	There was no significant difference between groups in the primary endpoint ( change from baseline : AAV2-neurturin , -7.09.92 ; sham , -5.210.01 ; p = 0.515 ) or in most secondary endpoints .
RESULTS	Two subjects had cerebral hemorrhages with transient symptoms .
RESULTS	No clinically meaningful adverse events were attributed to AAV2-neurturin .
CONCLUSIONS	AAV2-neurturin delivery to the putamen and substantia nigra bilaterally in PD was not superior to sham surgery .
CONCLUSIONS	The procedure was well tolerated , and there were no clinically significant adverse events related to AAV2-neurturin .

###24853059
BACKGROUND	Suicide behaviour in psychosis is a significant clinical and social problem .
BACKGROUND	There is a dearth of evidence for psychological interventions designed to reduce suicide risk in this population .
OBJECTIVE	To evaluate a novel , manualised , cognitive behavioural treatment protocol ( CBSPp ) based upon an empirically validated theoretical model .
METHODS	A randomly controlled trial with independent and masked allocated and assessment of CBSPp with TAU ( n = 25 , 24 sessions ) compared to TAU alone ( n = 24 ) using standardised assessments .
METHODS	Measures of suicide probability , and suicidal ideation were the primary outcomes and measures of hopelessness , depression , psychotic symptoms , functioning , and self-esteem were the secondary outcomes , assessed at 4 and 6 months follow-up .
RESULTS	The CBSPp group improved differentially to the TAU group on two out of three primary outcome measures of suicidal ideation and suicide probability , and on secondary outcomes of hopelessness related to suicide probability , depression , some psychotic symptoms and self-esteem .
CONCLUSIONS	CBSPp is a feasible intervention which has the potential to reduce proxy measures of suicide in psychotic patients .

###25567821
BACKGROUND	Lack of concordance between medications listed in the medical record and taken by the patient contributes to poor outcomes .
BACKGROUND	We sought to determine whether patients who received health coaching by medical assistants improved their medication concordance and adherence .
METHODS	This was a nonblinded , randomized , controlled , pragmatic intervention trial .
METHODS	English - or Spanish-speaking patients , age 18 to 75 years , with poorly controlled type 2 diabetes , hypertension , and/or hyperlipidemia were enrolled from 2 urban safety net clinics and randomized to receive 12 months of health coaching versus usual care .
RESULTS	Outcomes included concordance between medications documented in the medical record and those reported by the patient and adherence based on the patient-reported number of days ( of the last 7 ) on which patient took all prescribed medications .
RESULTS	The proportion of medications completely concordant increased in the coached group versus the usual care group ( difference in change , 10 % ; P = .05 ) .
RESULTS	The proportion of medications listed in the chart but not taken significantly decreased in the coached group compared with the usual care group ( difference in change , 17 % ; P = .013 ) .
RESULTS	The mean number of adherent days increased in the coached but not in the usual care group ( difference in change , 1.08 ; P < .001 ) .
CONCLUSIONS	Health coaching by medical assistants significantly increases medication concordance and adherence .

###25622882
OBJECTIVE	The main purpose of the present investigation was to determine whether intra-alveolar chlorhexidine ( CHX ) gel is an effective preventative treatment for alveolar osteitis ( AO ) , as has been strongly suggested by previous investigators .
OBJECTIVE	Another goal was to evaluate whether there is a correlation between the use of analgesics during the postoperative week and the development of AO , a correlation that could be a supplement to the commonly used diagnostic criteria for AO .
METHODS	A double-blinded randomized study was performed to assess whether intra-alveolar administration of CHX decreases AO .
METHODS	To achieve this objective , the extraction and postoperative course of 100 impacted mandibular third molars were studied .
METHODS	Ninety-seven percent of teeth operated on had a diagnosed pathology .
METHODS	The extraction alveoli were treated with CHX or placebo .
METHODS	The intake of analgesics was recorded for 7 days after the operation .
RESULTS	Statistically important differences in AO between the control and experimental groups were not found .
RESULTS	The intake of analgesics reflected the occurrence of AO with a high degree of importance .
CONCLUSIONS	The present study did not verify that application of CHX gel improves healing after removal of impacted third molars .
CONCLUSIONS	The patients ' postoperative analgesic intake reflected the development of AO .

###26427111
OBJECTIVE	To observe the curative effect of Huqian Wan on liver and kidney-Yin deficiency knee osteoarthritis ( KOA ) .
METHODS	One hundred patients were randomly divided , into a treatment ( 50 patients ) and control group ( 50 patients ) .
METHODS	In the treatment group , patients orally took the Chinese medicine Huqian Wan .
METHODS	Control group patients orally took Votalin , 75 mg , once a day , for 8 weeks .
METHODS	The visual analog scale ( VAS ) , Western Ontario and McMaster University Osteoarthritis Index ( WOMAC ) , and Medical Outcomes Study Short Form 36-Item Health Survey ( SF 36 ) were used to evaluate the curative effect before treatment and after 8 and 16 weeks of treatment .
RESULTS	VAS and WOMAC scores significantly decreased and SF 36 scores significantly increased after treatment in both groups compared with before treatment ( P < 0.05 ) .
RESULTS	There were significant differences in VAS , WOMAC , and SF 36 score changes between the two groups at week 16 ( P < 0.05 ) .
RESULTS	There was a significant increase in VAS and WOMAC scores in the control groups ( P < 0.05 ) between weeks 8 and 16 , but no significant difference was found in the treatment group ( P > 0.05 ) .
CONCLUSIONS	Huqian Wan could effectively improve the clinical symptoms and quality of life in patients with KOA .
CONCLUSIONS	It could also have a better and longer lasting curative effect without obvious adverse events compared with Votalin .

###25448092
BACKGROUND	Highly pathogenic avian influenza A/H5N1 viruses continue to circulate in birds and infect humans causing serious illness and death .
METHODS	In this randomized , observer-blinded study , adults 18 years of age ( n = 841 ) received 3.75 or 7.5 g hemagglutinin antigen ( HA ) of an AS03-adjuvanted ( AS03A or AS03B ) A/Indonesia/5 / 2005 H5N1 ( subclade 2.1 ) vaccine ( priming ) , followed by the same HA dose of AS03-adjuvanted A/turkey/Turkey / 1/05 H5N1 ( clade 2.2 ) influenza vaccine as a booster 6 or 18 months after priming ; an unprimed group received placebo at Day 0 , and 3.75 g HA of AS03A-adjuvanted booster vaccine at 6 and 18 months .
METHODS	Antibody responses were assessed by hemagglutination-inhibition assay ( HI ) .
METHODS	Microneutralization ( MN ) antibody and cellular immunoassays were assessed in a subset of participants .
RESULTS	Geometric mean titers ( GMTs ) and seroconversion rates ( SCRs ) were higher in primed vs. unprimed subjects against the booster strain 10 days following booster vaccination at month 6 and month 18 .
RESULTS	After the booster at 18 months , the lower limit of the 97.5 % confidence interval for the difference in SCR and GMT ratios between primed and unprimed subjects was > 15 % and > 2.0 , respectively , fulfilling the primary endpoint criteria for superiority against the booster strain .
RESULTS	MN and cellular immune responses corresponded with the immunogenicity seen in HI measures .
CONCLUSIONS	Adults primed with a dose-sparing oil-in-water adjuvanted H5N1 subclade vaccine had rapid and durable antibody responses to a heterologous subclade boosting vaccine given 6 or 18 months later .

###25019969
OBJECTIVE	Sodium picosulfate plus magnesium citrate ( PMC ) is a very effective , safe , and tolerated low-volume preparation for colon cleansing .
OBJECTIVE	This study evaluates whether split dosing is associated with a further increase in efficacy and acceptability compared with the standard dosing regimen .
METHODS	This was a multicenter , randomized , single-blind study .
METHODS	Adult outpatients undergoing colonoscopy received PMC either in the standard dosing ( two sachets taken the day before endoscopy ) or in split dosing ( the second sachet taken on the morning of colonoscopy ) .
METHODS	Bowel cleansing was assessed using the Boston Bowel Preparation Scale ( BBPS ) and was rated as adequate when BBPS was2 in each segment .
METHODS	Patient acceptance , satisfaction , and related symptoms were recorded .
RESULTS	A total of 862 patients were included in the study ( 577 in the standard group and 285 in the split-dose group ) .
RESULTS	Preparation was adequate in only 69.8 % of patients in the standard group compared with 85.8 % of those in the split-dose group ( P = 0.0001 ) .
RESULTS	Mean BBPS scores for the whole colon and the right colon were also statistically significantly higher in the split-dose group ( P = 0.0001 ) .
RESULTS	Both regimens were well tolerated , and only 8.0 % of patients reported discomfort .
RESULTS	Compliance was better with the split regimen ( 0.7 % vs. 7.1 % unable to take 75 % of the preparation ; P < 0.0001 ) , and willingness to repeat the preparation was similar .
RESULTS	Performing colonoscopy within 6 hours after preparation was associated with better colon cleansing .
RESULTS	Other predictors of poor cleansing at multivariate analysis were constipation , obesity , and discomfort during preparation .
CONCLUSIONS	The split-dose regimen of PMC was superior to the standard regimen in terms of effective colon cleansing and compliance.ClinicalTrial.gov ( NCT01909219 ) .

###24447074
BACKGROUND	Predictive low glucose management ( PLGM ) may help prevent hypoglycemia by stopping insulin pump delivery based on predicted sensor glucose values .
METHODS	Hypoglycemic challenges were simulated using the Food and Drug Administration-accepted glucose simulator with 100 virtual patients .
METHODS	PLGM was then tested with a system composed of a Paradigm ( ) insulin pump ( Medtronic , Northridge , CA ) , an Enlite glucose sensor ( Medtronic ) , and a BlackBerry ( ) ( Waterloo , ON , Canada ) - based controller .
METHODS	Subjects ( n = 22 ) on continuous subcutaneous insulin infusion ( five females , 17 males ; median [ range ] age , 15 [ range , 14-20 ] years ; median [ range ] diabetes duration , 7 [ 2-14 ] years ; median [ range ] glycated hemoglobin , 8.0 % [ 6.7-10 .4 % ] ) exercised until the PLGM system suspended insulin delivery or until the reference blood glucose value ( HemoCue ( ) ; HemoCue GmbH , Groostheim , Germany ) reached the predictive suspension threshold setting .
RESULTS	PLGM reduced hypoglycemia ( < 70mg/dL ) in silico by 26.7 % compared with no insulin suspension , as opposed to a 5.3 % reduction in hypoglycemia with use of low glucose suspend ( LGS ) .
RESULTS	The median duration of hypoglycemia ( time spent < 70mg/dL ) with PLGM was significantly less than with LGS ( 58min vs. 101min , respectively ; P < 0.001 ) .
RESULTS	In the clinical trial the hypoglycemic threshold during exercise was reached in 73 % of the patients , and hypoglycemia was prevented in 80 % of the successful experiments .
RESULTS	The mean ( SD ) sensor glucose at predictive suspension was 927mg/dL , resulting in a postsuspension nadir ( by HemoCue ) of 7722mg/dL .
RESULTS	The suspension lasted for 9035 ( range , 30-120 ) min , resulting in a sensor glucose level at insulin resumption of 9719mg/dL .
CONCLUSIONS	In silico modeling and early feasibility data demonstrate that PLGM may further reduce the severity of hypoglycemia beyond that already established for algorithms that use a threshold-based suspension .

###24758521
OBJECTIVE	To improve the quality of life ( QOL ) of patients with nasopharyngeal carcinoma ( NPC ) after chemoradiotherapy ( CRT ) , it is necessary to find an effective method to reduce the toxic side-effects of CRT .
METHODS	Between June 2007 and June 2010 , 83 previously untreated patients with NPC were randomized to receive CRT either with or without non-invasive extracorporeal radiofrequency ( ERF ) .
METHODS	All the patients underwent radiation , and weekly chemotherapy of paclitaxel 135-175 mg/m ( 2 ) and cisplatin 60-90 mg/m ( 2 ) .
METHODS	In addition , the patients in the treatment group also underwent non-invasive ERF on a radiofrequency machine at 13.56 MHz for 1 hour at 41-43C .
METHODS	After the completion of treatment , evaluation was carried out to determine the survival rate , disease-free survival time , and QOL .
METHODS	QOL was analyzed by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 ( EORTC QLQ-C30 ) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Cancer Module ( EORTC QLQ-H & N35 ) every 6 months during the three-year period .
RESULTS	After completion of the treatments , the 36-month survival rate was 0.730 in the treatment group and 0.535 in the reference group ( p = 0.041 ) ; the average disease-free survival time was 48 months in the treatment group and only 37.5 months in the reference group ( p = 0.048 ) .
RESULTS	In the post - treatment questionnaires , several NPC-specific ( pain , swallowing , speech , social eating , opening mouth , dry mouth , sticky saliva ) QOL domains were better preserved with CRT + ERF compared to CRT at different time-points .
CONCLUSIONS	The combination treatment of ERF with CRT can prolong the survival rate and disease-free survival time and improve the QOL for patients with NPC .

###25332317
OBJECTIVE	The antiproteinuric effect of a renin-angiotensin-aldosterone system blockade can be magnified by dietary salt restriction .
OBJECTIVE	This study sought to determine the effect of intensive low-salt diet education on BP and urine albumin excretion in nondiabetic patients with hypertension and albuminuria .
METHODS	This study was conducted between March of 2012 and March of 2013 as an open-label , randomized , controlled trial .
METHODS	After a run-in period of 8 weeks , all patients received the angiotensin II receptor blocker olmesartan ( 40 mg daily ) .
METHODS	Patients were then divided into two groups .
METHODS	One group was treated for another 8 weeks with angiotensin II receptor blocker plus conventional low-salt diet education , and the other group was treated for 8 weeks with angiotensin II receptor blocker plus intensive low-salt diet education .
METHODS	The final analyses was performed with 245 completed patients .
RESULTS	The amount of daily albuminuria was significantly decreased from 0 ( 566.0 [ 25.0-5398 .6 ] mg/d ) to 8 weeks ( 282.5 [ 16.1-4898 .5 ] mg/d ; P < 0.001 ) .
RESULTS	From 8 to 16 weeks , the 24-hour urinary sodium excretion was decreased by 36.05.9 mmol/d in the intensive education group and 8.84.9 mmol/d in the conventional education group ( interaction P < 0.001 ) .
RESULTS	Patients who completed intensive low-salt diet education exhibited greater decreases in urinary albumin excretion than the control group ( change in albuminuria from 8 to 16 weeks , -154.0 versus 0.4 mg/d ; P = 0.01 ) .
RESULTS	Urinary albumin excretion tended to decrease as the 24-hour urinary sodium excretion amount decreased ( R = 0.32 ; 95 % confidence interval , 0.20 to 0.43 ; P < 0.001 ) .
CONCLUSIONS	The 24-hour urinary albumin excretion was decreased more in patients in the intensive low-salt diet education group than patients in the conventional education group .
CONCLUSIONS	Weekly intensive education on a low-salt diet would be a suitable method for clinical practice .

###24859124
OBJECTIVE	This study was conducted to develop an asthma management education program for preschool children using Roy 's adaptation theory as a framework and examining the effects of this program on adaptation to asthma treatment .
METHODS	A non-equivalent control group pre-post-test design was used with 43 preschool children diagnosed with asthma and required to be hospitalized for inhalation therapy .
METHODS	An intervention group ( n = 23 ) participated in the educational program and a control group ( n = 20 ) received regular treatment .
METHODS	The education program was conducted and evaluated from June 30 to October 31 2012 , a maximum 3 times every 24 hours during hospitalization .
METHODS	Two nurses conducted the program using the teaching method of Gagne and Briggs ; instruction design theory through questionnaires to measure perception of disease , behavior of adaptation to treatment with inhalation therapy .
RESULTS	Effects of asthma management education program ; scores for face-pain rating decreased and time of adaptation to treatment increased significantly in the experimental group compared to the control group but no significant differences were found for perception of the disease 's cause and treatment .
CONCLUSIONS	Results indicate that the asthma management education program has positive effects on adaptation to asthma treatment of preschoolers .

###24370263
BACKGROUND	Nutrition in the first 1,000 days of life ( during pregnancy and the first two years ) is critical for child growth and survival .
BACKGROUND	Poor maternal , infant and young child nutrition ( MIYCN ) practices are widely documented in Kenya , with potential detrimental effects on child growth and survival .
BACKGROUND	This is particularly a problem in slums , where most urban residents live .
BACKGROUND	For example , exclusive breastfeeding for the first six months is only about two per cent .
BACKGROUND	Innovative strategies to reach slum residents are therefore needed .
BACKGROUND	Strategies like the Baby Friendly Hospital Initiative have proven effective in some settings but their effectiveness in resource-limited settings , including slums where many women do not deliver in hospital , is questionable .
BACKGROUND	We propose to test the effectiveness of a home-based intervention on infant feeding practices , nutrition and health outcomes of infants born in two slums in Nairobi , Kenya .
METHODS	The study , employing a cluster-randomised study design , will be conducted in two slums in Nairobi : Korogocho and Viwandani where 14 community units ( defined by the Government 's health care system ) will form the unit of randomization .
METHODS	A total of 780 pregnant women and their respective child will be recruited into the study .
METHODS	The mother-child pair will be followed up until the child is one year old .
METHODS	Recruitment will last approximately one year and three months from September 2012 to December 2013 .
METHODS	The mothers will receive regular , personalised , home-based counselling by trained Community Health Workers on MIYCN .
METHODS	Regular assessment of knowledge , attitudes and practices on MIYCN will be done , coupled with assessments of nutritional status of the mother-child pairs and diarrhea morbidity for the children .
METHODS	Statistical methods will include analysis of covariance and multinomial logistic regression .
METHODS	Additionally , cost-effectiveness analysis will be done .
METHODS	The study is funded by the Wellcome Trust and will run from March 2012 to February 2015 .
CONCLUSIONS	Interventions aimed at promoting optimal breastfeeding and complementary feeding practices are considered to have high impact and could prevent a fifth of the under-five deaths in countries with high mortality rates .
CONCLUSIONS	This study will inform policy and practice in Kenya and similar settings regarding delivery mechanisms for such high-impact interventions , particularly among urban poor populations .
BACKGROUND	ISRCTN83692672 .

###24910935
OBJECTIVE	Precut techniques have been used to facilitate biliary cannulation during difficult endoscopic retrograde cholangiopancreatography .
OBJECTIVE	Presently , needle-knife sphincterotomy ( NKS ) is a commonly used precut technique .
OBJECTIVE	Since its first description , transpancreatic sphincterotomy , as an alternative method for bile duct entry when conventional biliary cannulation failed , has been debated on its success rate of cannulation and its complications , such as increased incidence of pancreatitis .
OBJECTIVE	Guidewire techniques are another effective method to improve the success rate of selective bile duct cannulation .
OBJECTIVE	This is a single-center prospective randomized controlled trial aimed to compare success rate , cannulation time , and complications of guidewire-assisted transpancreatic sphincterotomy ( GATS ) and NKS for difficult biliary cannulation .
METHODS	Between July 2010 and October 2013 , consecutive patients who failed in the standard biliary cannulation were randomly assigned to the GATS and NKS groups .
METHODS	The outcome measures included success rate , cannulation time , and complications .
RESULTS	A total of 149 patients were enrolled and analyzed : 73 in the GATS group and 79 in the NKS group .
RESULTS	The characteristics of the 2 groups were similar .
RESULTS	Bile duct cannulation was successful in 70 patients ( 95.9 % ) in the GATS group and 64 ( 84.2 % ) in the NKS group ( P = 0.018 ) .
RESULTS	The median cannulation time spent in precut was 193 seconds in the GATS group and 485 seconds in the NKS group ( P < 0.001 ) .
RESULTS	There was no difference between the groups for the incidence of complications , pancreatitis , and hemorrhage ( 9.6 % vs. 10.5 % , 6.8 % vs. 6.6 % , 1.4 % vs. 3.9 % , respectively ) .
RESULTS	No perforation occurred .
CONCLUSIONS	GATS compared with NKS increases biliary cannulation rate and requires less cannulation time during difficult biliary access .
CONCLUSIONS	This technique is not associated with an increased risk for complications .
CONCLUSIONS	It seems to be an effective and safe alternative for biliary access during difficult endoscopic retrograde cholangiopancreatography .

###24368433
BACKGROUND	The postprandial triglyceride-rich lipoprotein ( TRL ) concentration is a recognized independent cardiovascular disease risk factor .
BACKGROUND	Diet is the natural approach for these postprandial alterations .
BACKGROUND	Dietary polyphenols and long chain n-3 polyunsaturated fatty acids ( LCn3s ) are associated with a lower cardiovascular disease risk .
OBJECTIVE	This randomized controlled study evaluated , in persons with a high risk of cardiovascular disease , the effects of diets naturally rich in polyphenols and/or marine LCn3s on plasma TRLs and urinary 8-isoprostane concentrations , a biomarker of oxidative stress .
METHODS	According to a 2 2 factorial design , 86 overweight/obese individuals with a large waist circumference and any other component of the metabolic syndrome were randomly assigned to an isoenergetic diet 1 ) poor in LCn3s and polyphenols , 2 ) rich in LCn3s , 3 ) rich in polyphenols , or 4 ) rich in LCn3s and polyphenols .
METHODS	The diets were similar in all other components .
METHODS	Before and after the 8-wk intervention , fasting and postmeal TRLs and 8-isoprostane concentrations in 24-h urine samples were measured .
RESULTS	Dietary adherence was good in all participants .
RESULTS	Polyphenols significantly reduced fasting triglyceride concentrations ( 2-factor ANOVA ) in plasma ( P = 0.023 ) and large very-low-density lipoproteins ( VLDLs ) ( P = 0.016 ) and postprandial triglyceride total area under the curve in plasma ( P = 0.041 ) and large VLDLs ( P = 0.004 ) .
RESULTS	LCn3s reduced postprandial chylomicron cholesterol and VLDL apolipoprotein B-48 .
RESULTS	The concentrations of urinary 8-isoprostane decreased significantly with the polyphenol-rich diets .
RESULTS	Lipoprotein changes induced by the intervention significantly correlated with changes in 8-isoprostane .
CONCLUSIONS	Diets naturally rich in polyphenols positively influence fasting and postprandial TRLs and reduce oxidative stress .
CONCLUSIONS	Marine LCn3s reduce TRLs of exogenous origin .
CONCLUSIONS	Through their effects on postprandial lipemia and oxidative stress , polyphenols may favorably affect cardiovascular disease risk .

###24810282
BACKGROUND	Poor adherence to CPAP treatment in OSA adversely affects the effectiveness of this therapy .
BACKGROUND	This randomized controlled trial ( RCT ) examined the efficacy of a brief motivational enhancement education program in improving adherence to CPAP treatment in subjects with OSA .
METHODS	Subjects with newly diagnosed OSA were recruited into this RCT .
METHODS	The control group received usual advice on the importance of CPAP therapy and its care .
METHODS	The intervention group received usual care plus a brief motivational enhancement education program directed at enhancing the subjects ' knowledge , motivation , and self-efficacy to use CPAP through the use of a 25-min video , a 20-min patient-centered interview , and a 10-min telephone follow-up .
METHODS	Self-reported daytime sleepiness adherence-related cognitions and quality of life were assessed at 1 month and 3 months .
METHODS	CPAP usage data were downloaded at the completion of this 3-month study .
RESULTS	One hundred subjects with OSA ( mean SD , age 52 10 years ; Epworth Sleepiness Scales [ ESS ] , 9 5 ; median [ interquartile range ] apnea-hypopnea index , 29 [ 20 , 53 ] events/h ) prescribed CPAP treatment were recruited .
RESULTS	The intervention group had better CPAP use ( higher daily CPAP usage by 2 h/d [ Cohen d = 1.33 , P < .001 ] , a fourfold increase in the number using CPAP for 70 % of days with 4 h/d [ P < .001 ] ) , and greater improvements in daytime sleepiness ( ESS ) by 2.2 units ( P = .001 ) and treatment self-efficacy by 0.2 units ( P = .012 ) compared with the control group .
CONCLUSIONS	Subjects with OSA who received motivational enhancement education in addition to usual care were more likely to show better adherence to CPAP treatment , with greater improvements in treatment self-efficacy and daytime sleepiness .
BACKGROUND	ClinicalTrials.gov ; No. : NCT01173406 ; URL : www.clinicaltrials.gov .

###25033643
OBJECTIVE	This study aimed to observe the postoperative pain rate and degree of pain in preschool children with cleft lip and palate , and investigate the effect of nursing intervention on pain relief .
METHODS	A total of 120 hospitalized cases of three - to seven-year-old preschool children with cleft lip and palate were selected from May to October 2011 .
METHODS	The subjects were randomly divided into the control group and experimental groups 1 , 2 , and 3 .
METHODS	The control group used conventional nursing methods , experimental group 1 used analgesic drug treatment , experimental group 2 used psychological nursing interventions , and experimental group 3 used both psychological nursing intervention and analgesic drug treatment .
METHODS	After 6 , 12 , 24 , and 48 h , pain self-assessment , pain parent-assessment , and pain nurse-assessment were calculated for the four groups using the pain assessment forms , and their ratings were compared .
RESULTS	The postoperative pain rates of the four groups ranged from 50.0 % to 73.3 % .
RESULTS	The difference among the four groups was statistically significant ( P < 0.001 ) .
RESULTS	The differences among the control group and experimental groups 1 and 2 were not statistically significant ( P = 0.871 ) , whereas the differences among experimental group 3 and the other groups were statistically significant ( P < 0.001 ) .
CONCLUSIONS	Postoperative pain in preschool children with cleft lip and palate is common .
CONCLUSIONS	Psychological nursing intervention with analgesic treatment is effective in relieving postoperative pain .

###24789736
OBJECTIVE	We conducted a pilot study comparing problem solving therapy for primary care ( PST-PC ) to a dietary education control condition in middle-aged and older veterans with symptoms of emotional distress and subsyndromal depression .
METHODS	This was a two-site study at the VA Pittsburgh Healthcare System and Philadelphia VA Medical Center .
METHODS	Participants included veterans > 50 years of age referred from primary care clinics who were eligible if they obtained a pre-screen score > 11 on the Centers for Epidemiologic Studies Depression ( CES-D ) scale .
METHODS	Exclusions were a DSM-IV Major Depressive Episode within the past year , active substance abuse/dependence within 1 month , current antidepressant therapy , and a Mini mental status exam score < 24 .
METHODS	Participants were randomized to receive one of two interventions -- either PST-PC or an attention control condition consisting of dietary education ( DIET ) -- each consisting of six to eight sessions within a 4-month period .
RESULTS	Of 45 individuals randomized , 23 ( 11 PST-PC and 12 DIET ) completed treatment .
RESULTS	Using regression models in completers that examined outcomes at end of treatment while controlling for baseline scores , there were significant differences between treatment groups in SF-36 mental health component scores but not in depressive symptoms ( as assessed with either the 17-item Hamilton Rating Scale for Depression or the Beck Depression Inventory ) , social problem solving skills , or physical health status ( SF-36 physical health component score ) .
CONCLUSIONS	These pilot study findings suggest that a six-to-eight session version of PST-PC may lead to improvements in mental health functioning in primary care veterans with subsyndromal depressive symptoms .

###24499130
OBJECTIVE	To evaluate the effectiveness of Koru , a mindfulness training program for college students and other emerging adults .
METHODS	Ninety students ( 66 % female , 62 % white , 71 % graduate students ) participated between Fall 2012 and Spring 2013 .
METHODS	Randomized controlled trial .
METHODS	It was hypothesized that Koru , compared with a wait-list control group , would reduce perceived stress and sleep problems , and increase mindfulness , self-compassion , and gratitude .
RESULTS	As hypothesized , results showed significant Group ( Koru , Wait-List ) Time ( Pre , Post ) interactions for improvements in perceived stress ( F [ 1 , 76.40 ] = 4.50 , p = .037 , d = .45 ) , sleep problems ( F [ 1 , 79.49 ] = 4.71 , p = .033 , d = .52 ) , mindfulness ( F [ 1 , 79.09 ] = 26.80 , p < .001 , d = 95 ) , and self-compassion ( F [ 1 , 74.77 ] = 18.08 , p < .001 , d = .75 ) .
RESULTS	All significant effects were replicated in the wait-list group .
RESULTS	Significant correlations were observed among changes in perceived stress , sleep problems , mindfulness , and self-compassion .
CONCLUSIONS	Results support the effectiveness of the Koru program for emerging adults in the university setting .

###25468896
OBJECTIVE	Past studies have shown that higher macular pigment optical density ( MPOD ) and lutein ( L ) and zeaxanthin ( Z ) supplementation are related to improvements in glare disability , photostress recovery , and chromatic contrast .
OBJECTIVE	This study assessed those links using a randomized , double-blind , placebo-controlled design .
METHODS	The visual effects of 1 year of supplementing L ( 10 mg/d ) and Z ( 2 mg/d ) were investigated .
METHODS	One hundred fifteen young , healthy subjects were recruited and randomized into the study ( 58 received placebo , 57 L+Z ) .
METHODS	Several dependent measures were collected at baseline and then once every 3 months : serum L and Z measured by HPLC chromatography ; MPOD measured using customized heterochromatic flicker photometry ; photostress recovery assessed by measuring the time needed to recover visual acquisition of a grating target after 30 seconds of an intense xenon white flash exposure ; glare disability evaluated as the energy in a surrounding annulus necessary to veil a central grating target ; and chromatic contrast assessed by measuring thresholds for a yellow grating target superposed on a 460-nm background .
RESULTS	Macular pigment optical density increased significantly versus placebo at all eccentricities ( 10 , 30 , 60 , and 105 minutes from the center of the macula ) .
RESULTS	Serum L and Z also increased significantly by the first follow-up visit ( at 3 months ) , and remained elevated throughout the intervention period of 1 year .
RESULTS	Chromatic contrast and photostress recovery time improved significantly versus placebo .
RESULTS	Glare disability was correlated with macular pigment density throughout the study period but did not increase significantly in the treated group .
CONCLUSIONS	Daily supplementation with L+Z resulted in significant increase in serum levels and MPOD and improvements in chromatic contrast and recovery from photostress .
CONCLUSIONS	These results are consistent with past studies showing that increasing MPOD leads to improved visual performance .
CONCLUSIONS	( ClinicalTrials.gov number , NCT00909090 . )

###24401221
OBJECTIVE	Combination therapy may help high-risk patients achieve low-density lipoprotein cholesterol ( LDL-C ) goals .
OBJECTIVE	Impact of rosuvastatin 10 or 20 mg plus ezetimibe 10 mg ( RSV10/EZE10 and RSV20/EZE10 ) has not been fully characterized previously .
OBJECTIVE	GRAVITY ( NCT00525824 ) compared efficacy , safety and effect on biomarkers of RSV10/EZE10 and RSV20/EZE10 vs. simvastatin 40 mg and 80 mg plus EZE10 ( SIM40/EZE10 and SIM80/EZE10 ) in patients with coronary heart disease ( CHD ) or CHD risk equivalent .
METHODS	Adult patients ( n = 833 ) were randomized to RSV10/EZE10 , RSV20/EZE10 , SIM40/EZE10 or SIM80/EZE10 .
METHODS	Following a 6-week dietary lead-in , patients received 6 weeks ' statin monotherapy followed by same statin dose plus ezetimibe for 6 more weeks .
METHODS	Primary endpoint was LDL-C change from baseline to 12 weeks .
RESULTS	Significantly greater ( p < 0.05 ) reductions in LDL-C and other atherogenic lipids were observed with RSV20/EZE10 vs. SIM40/EZE10 and SIM80/EZE10 and with RSV10/EZE10 vs. SIM40/EZE10 .
RESULTS	A significantly greater proportion of patients achieved LDL-C goals of < 100 mg/dl and < 70 mg/dl with RSV20/EZE10 vs. SIM40/EZE10 and SIM80/EZE10 and with RSV10/EZE10 vs. SIM40/EZE10 .
RESULTS	LDL-C was reduced 10-14 % further with combination therapy vs. monotherapy .
RESULTS	Statin monotherapy reduced cholesterol and bile acid synthesis biomarkers , ezetimibe reduced - sitosterol ( sterol absorption marker ) , and combination therapy achieved additive reductions in lipoprotein-associated phospholipase A2 mass and activity , free cholesterol and 7-ketocholesterol .
RESULTS	Safety profiles of rosuvastatin/ezetimibe and simvastatin/ezetimibe combinations were comparable .
CONCLUSIONS	Co-administration of rosuvastatin 10 or 20 mg plus ezetimibe achieved significant improvements in lipid profiles in high-risk patients vs. simvastatin 40 or 80 mg plus ezetimibe .

###24281460
OBJECTIVE	Micronutrient deficiencies occur early in human immunodeficiency virus ( HIV ) infection , and supplementation with micronutrients may be beneficial ; however , its effectiveness has not been investigated early in HIV disease among adults who are antiretroviral therapy ( ART ) naive .
OBJECTIVE	To investigate whether long-term micronutrient supplementation is effective and safe in delaying disease progression when implemented early in adults infected with HIV subtype C who are ART-naive .
METHODS	Randomized clinical trial of supplementation with either daily multivitamins ( B vitamins and vitamins C and E ) , selenium alone , or multivitamins with selenium vs placebo in a factorial design for 24 months .
METHODS	The study was conducted in 878 patients infected with HIV subtype C with a CD4 cell count greater than 350/L who were not receiving ART at Princess Marina Hospital in Gaborone , Botswana , between December 2004 and July 2009 .
METHODS	Daily oral supplements of B vitamins and vitamins C and E , selenium alone , or multivitamins plus selenium , compared with placebo .
METHODS	Reaching a CD4 cell count less than 200/L until May 2008 ; after this date , reaching a CD4 cell count of 250/L or less , consistent with the standard of care in Botswana for initiation of ART at the time of the study .
RESULTS	There were 878 participants enrolled and randomized into the study .
RESULTS	All participants were ART-naive throughout the study .
RESULTS	In intent-to-treat analysis , participants receiving the combined supplement of multivitamins plus selenium had a significantly lower risk vs placebo of reaching CD4 cell count 250/L or less ( adjusted hazard ratio [ HR ] , 0.46 ; 95 % CI , 0.25-0 .85 ; P = .01 ; absolute event rate [ AER ] , 4.79 / 100 person-years ; censoring rate , 0.92 ; 17 events ; placebo AER , 9.22 / 100 person-years ; censoring rate , 0.85 ; 32 events ) .
RESULTS	Multivitamins plus selenium in a single supplement , vs placebo , also reduced the risk of secondary events of combined outcomes for disease progression ( CD4 cell count 250/L , AIDS-defining conditions , or AIDS-related death , whichever occurred earlier [ adjusted HR , 0.56 ; 95 % CI , 0.33-0 .95 ; P = .03 ; AER , 6.48 / 100 person-years ; censoring rate , 0.90 ; 23 events ] ) .
RESULTS	There was no effect of supplementation on HIV viral load .
RESULTS	Multivitamins alone and selenium supplementation alone were not statistically different from placebo for any end point .
RESULTS	Reported adverse events were adjudicated as unlikely to be related to the intervention , and there were no notable differences in incidence of HIV-related and health-related events among study groups .
CONCLUSIONS	In ART-naive HIV-infected adults , 24-month supplementation with a single supplement containing multivitamins and selenium was safe and significantly reduced the risk of immune decline and morbidity .
CONCLUSIONS	Micronutrient supplementation may be effective when started in the early stages of HIV disease .

###25335439
BACKGROUND	The production of high quality systematic reviews requires rigorous methods that are time-consuming and resource intensive .
BACKGROUND	Citation screening is a key step in the systematic review process .
BACKGROUND	An opportunity to improve the efficiency of systematic review production involves the use of non-expert groups and new technologies for citation screening .
BACKGROUND	We performed a pilot study of citation screening by medical students using four screening methods and compared students ' performance to experienced review authors .
METHODS	The aims of this pilot randomised controlled trial were to provide preliminary data on the accuracy of title and abstract screening by medical students , and on the effect of screening modality on screening accuracy and efficiency .
METHODS	Medical students were randomly allocated to title and abstract screening using one of the four modalities and required to screen 650 citations from a single systematic review update .
METHODS	The four screening modalities were a reference management software program ( EndNote ) , Paper , a web-based systematic review workflow platform ( ReGroup ) and a mobile screening application ( Screen2Go ) .
METHODS	Screening sensitivity and specificity were analysed in a complete case analysis using a chi-squared test and Kruskal-Wallis rank sum test according to screening modality and compared to a final set of included citations selected by expert review authors .
RESULTS	Sensitivity of medical students ' screening decisions ranged from 46.7 % to 66.7 % , with students using the web-based platform performing significantly better than the paper-based group .
RESULTS	Specificity ranged from 93.2 % to 97.4 % with the lowest specificity seen with the web-based platform .
RESULTS	There was no significant difference in performance between the other three modalities .
CONCLUSIONS	Medical students are a feasible population to engage in citation screening .
CONCLUSIONS	Future studies should investigate the effect of incentive systems , training and support and analytical methods on screening performance .
BACKGROUND	Cochrane Database CD001048 .

###24280469
OBJECTIVE	To evaluate the clinical effect of Traditional Chinese Spinal Orthopedic Manipulation ( TCSOM ) in treating Irritable Bowel Syndrome ( IBS ) in comparison with Pinaverium Bromide Dicetel ( PBD ) , and to assess a possible cause for IBS .
METHODS	60 cases of IBS patients were randomly divided into two groups : TCSOM and PBD .
METHODS	All patients in the TCSOM group were treated with a 5-time spinal manipulations .
METHODS	The symptoms of pre-treatment and post-treatment were evaluated based on bowel symptom scale ( BSS ) scores .
METHODS	A symptom improvement rating ( SIR ) and patient subjective assessment ( PSA ) were implemented in order to evaluate the effects of the treatments , and to statistically compare the two groups .
RESULTS	The symptoms of 23 patients of the TCSOM group disappeared soon after spinal manipulation and 6 cases were significantly improved .
RESULTS	The BSS scores in the TCSOM group were significantly lower than those in the PBD group post-treatment .
RESULTS	According to the SIR which was based on the BSS , the TCSOM research group included 14 cases with excellent results , 13 cases with good , and 3 cases with poor .
RESULTS	Adverse side effects to the treatment were not reported .
RESULTS	Based on the BSS , the PBD research group reported 7 cases with excellent results , 8 cases with good and 15 cases with poor .
RESULTS	All cases were statistically analyzed , revealing a significant difference ( P < 0.001 ) between the two groups .
CONCLUSIONS	The displacement of inter-vertebral disks and/or vertebra in the thoracic or lumbar region seems to be a contributing factor in the symptoms of irritable bowel syndrome .
CONCLUSIONS	Thumb pressing manipulation on jiaji points in the thoracic and/or lumbar region can correct the displacement of inter-vertebral disks and/or vertebra , resolving the stimuli caused by pressure exerted on the nerves and vessels around the spine .
CONCLUSIONS	So it is an effective treatment for IBS .

###25743367
OBJECTIVE	Major depressive disorder ( MDD ) is associated with decreased physical activity and increased rates of the metabolic syndrome ( MetS ) , a risk factor for the development of type 2 diabetes and cardiovascular disorders .
OBJECTIVE	Exercise training has been shown to improve cardiorespiratory fitness and metabolic syndrome factors .
OBJECTIVE	Therefore , our study aimed at examining whether patients receiving an exercise program as an adjunct to inpatient treatment will benefit in terms of physiological and psychological factors .
METHODS	Fourty-two inpatients with moderate to severe depression were included .
METHODS	Twenty-two patients were randomized to additional 3x weekly exercise training ( EXERCISE ) and compared to treatment as usual ( TAU ) .
METHODS	Exercise capacity was assessed as peak oxygen uptake ( VO2peak ) , ventilatory anaerobic threshold ( VAT ) and workload expressed as Watts ( W ) .
METHODS	Metabolic syndrome was defined according to NCEP ATPIII panel criteria .
RESULTS	After 6 weeks of treatment , cardiorespiratory fitness ( VO2peak , VAT , Watt ) , waist circumference and HDL cholesterol were significantly improved in EXERCISE participants .
RESULTS	Treatment response expressed as 50 % MADRS reduction was more frequent in the EXERCISE group .
CONCLUSIONS	Adjunctive exercise training in depressed inpatients improves physical fitness , MetS factors , and psychological outcome .
CONCLUSIONS	Given the association of depression with cardiometablic disorders , exercise training is recommended as an adjunct to standard antidepressant treatment .

###26077477
OBJECTIVE	Ten-valent pneumococcal conjugate vaccine ( PCV10 ) was earlier shown to reduce clinically suspected , non-laboratory-confirmed invasive pneumococcal disease ( IPD ) in a cluster-randomized trial ( the Finnish Invasive Pneumococcal disease trial ) .
OBJECTIVE	PCV10 was introduced into the Finnish national vaccination program in September 2010 using a 3-dose schedule .
OBJECTIVE	We evaluated the impact of PCV10 on clinically suspected IPD among vaccine-eligible children in a population-based nationwide study .
METHODS	The target cohort eligible for vaccination program ( children born June 2010-September 2013 ) was compared with 2 season - and age-matched ( ages 3-42 months ) reference cohorts before PCV10 introduction .
METHODS	The trial period ( January 2009-August 2010 ) was excluded .
METHODS	Hospitals ' inpatient and outpatient discharge notifications with International Classification of Diseases , 10th Revision , diagnoses compatible with IPD ( A40 .3 / B95 .3 / G00 .1 / M00 .1 ) and unspecified sepsis ( A40 .9 / A41 .9 / A49 .9 / G00/G00 .9 / I30 .1 / M00/M00 .9 / B95 .5 ) were collected from the national Care Register .
METHODS	Laboratory-confirmed IPD cases were excluded .
METHODS	Rates of register-based non-laboratory-confirmed IPD ( or unspecified sepsis ) before and after PCV10 implementation were calculated .
RESULTS	The rate of register-based non-laboratory-confirmed IPD episodes was 32 in 100000 person-years in the vaccine-eligible target cohort and 94 in the combined reference cohorts .
RESULTS	Relative rate reduction was 66 % ( 95 % confidence interval : 59-73 ) and absolute rate reduction 62 in 100000 person-years .
RESULTS	For the more sensitive case definition of register-based non-laboratory-confirmed IPD or unspecified sepsis , the relative rate reduction was 34 % ( 95 % confidence interval 29-39 ) , but the absolute reduction was as high as 122 in 100000 person-years .
CONCLUSIONS	This is the first report demonstrating nationwide PCV impact on clinically suspected IPD during routine vaccination program .
CONCLUSIONS	The large absolute rate reductions observed have major implications for cost-effectiveness of PCVs .

###25847819
BACKGROUND	The authors analyzed a preliminary report of patient-reported outcomes ( PROs ) among men who received high-dose radiation therapy ( RT ) on Radiation Therapy Oncology Group study 0126 ( a phase 3 dose-escalation trial ) with either 3-dimensional conformal RT ( 3D-CRT ) or intensity-modulated RT ( IMRT ) .
METHODS	Patients in the 3D-CRT group received 55.8 gray ( Gy ) to the prostate and proximal seminal vesicles and were allowed an optional field reduction ; then , they received 23.4 Gy to the prostate only .
METHODS	Patients in the IMRT group received 79.2 Gy to the prostate and proximal seminal vesicles .
METHODS	PROs were assessed at 0 months ( baseline ) , 3 months , 6 months , 12 months , and 24 months and included bladder and bowel function assessed with the Functional Alterations due to Changes in Elimination ( FACE ) instrument and erectile function assessed with the International Index of Erectile Function ( IIEF ) .
METHODS	Analyses included the patients who completed all data at baseline and for at least 1 follow-up assessment , and the results were compared with an imputed data set .
RESULTS	Of 763 patients who were randomized to the 79.2-Gy arm , 551 patients and 595 patients who responded to the FACE instrument and 505 patients and 577 patients who responded to the IIEF were included in the completed and imputed analyses , respectively .
RESULTS	There were no significant differences between modalities for any of the FACE or IIEF subscale scores or total scores at any time point for either the completed data set or the imputed data set .
CONCLUSIONS	Despite significant reductions in dose and volume to normal structures using IMRT , this robust analysis of 3D-CRT and IMRT demonstrated no difference in patient-reported bowel , bladder , or sexual functions for similar doses delivered to the prostate and proximal seminal vesicles with IMRT compared with 3D-CRT delivered either to the prostate and proximal seminal vesicles or to the prostate alone .

###24952862
BACKGROUND	Extensive coronary artery disease ( CAD ) is associated with higher risk .
BACKGROUND	In this substudy of the PLATO trial , we examined the effects of randomized treatment on outcome events and safety in relation to the extent of CAD .
METHODS	Patients were classified according to presence of extensive CAD ( defined as 3-vessel disease , left main disease , or prior coronary artery bypass graft surgery ) .
METHODS	The trial 's primary and secondary end points were compared using Cox proportional hazards regression .
RESULTS	Among 15,388 study patients for whom the extent of CAD was known , 4,646 ( 30 % ) had extensive CAD .
RESULTS	Patients with extensive CAD had more high-risk characteristics and experienced more clinical events during follow-up .
RESULTS	They were less likely to undergo percutaneous coronary intervention ( 58 % vs 79 % , P < .001 ) but more likely to undergo coronary artery bypass graft surgery ( 16 % vs 2 % , P < .001 ) .
RESULTS	Ticagrelor , compared with clopidogrel , reduced the composite of cardiovascular death , myocardial infarction , and stroke in patients with extensive CAD ( 14.9 % vs 17.6 % , hazard ratio [ HR ] 0.85 [ 0.73-0 .98 ] ) similar to its reduction in those without extensive CAD ( 6.8 % vs 8.0 % , HR 0.85 [ 0.74-0 .98 ] , Pinteraction = .99 ) .
RESULTS	Major bleeding was similar with ticagrelor vs clopidogrel among patients with ( 25.7 % vs 25.5 % , HR 1.02 [ 0.90-1 .15 ] ) and without ( 7.3 % vs 6.4 % , HR 1.14 [ 0.98-1 .33 ] , Pinteraction = .24 ) extensive CAD .
CONCLUSIONS	Patients with extensive CAD have higher rates of recurrent cardiovascular events and bleeding .
CONCLUSIONS	Ticagrelor reduced ischemic events to a similar extent both in patients with and without extensive CAD , with bleeding rates similar to clopidogrel .

###25557952
OBJECTIVE	The efficacy and safety of interferon-free regimens for the treatment of chronic hepatitis C virus ( HCV ) infections require further evaluation and comparison with those of interferon-containing regimens .
OBJECTIVE	We compared a regimen of peginterferon , ribavirin , and sofosbuvir with a regimen of simeprevir and sofosbuvir in patients with HCV infection and unfavorable treatment features .
METHODS	We performed a prospective open-label study of 82 patients with chronic HCV genotype 1a infection and Child 's grade A cirrhosis enrolled from 2 clinics at a single center in Atlanta , Georgia , from December 2013 through January 2014 .
METHODS	Fifty patients ( 61 % ) had not responded to treatment with peginterferon and ribavirin ( null responders ) , and 32 ( 39 % ) were therapy naive ; 39 ( 48 % ) were African American .
METHODS	Subjects were assigned randomly to groups given simeprevir ( 150 mg/day ) and sofosbuvir ( 400 mg/day ) ( n = 58 in the final analysis ) or peginterferon alfa 2b ( 1.5 mcg/kg/wk ) , ribavirin ( 1000-1200 mg/day ) , and sofosbuvir ( 400 mg/day ) ( n = 24 in the final analysis ) .
METHODS	Both regimens were given for 12 weeks .
METHODS	The primary trial end point was the proportion of patients with undetectable HCV-RNA levels 12 weeks after therapy completion ( SVR12 ) .
RESULTS	A significantly greater percentage of patients ( 93 % ) given simeprevir and sofosbuvir achieved an SVR12 than those given the interferon-containing regimen ( 75 % ) ( P = .02 ) .
RESULTS	Patients given the interferon-containing regimen had a significantly higher rate of virologic relapse than patients given simeprevir and sofosbuvir ( P = .009 ) , as well as worse self-reported outcomes and more side effects .
RESULTS	Quality-of-life scores were higher in patients with SVR12 than those without , regardless of treatment regimen .
CONCLUSIONS	In a prospective study of patients with chronic HCV genotype 1a infection and cirrhosis ( 48 % African American and 61 % prior null responders ) , a 12-week regimen of simeprevir and sofosbuvir produced a significantly higher rate of SVR12 and was better tolerated , with a lower viral relapse rate , than a 12-week regimen of peginterferon , ribavirin , and sofosbuvir .
CONCLUSIONS	Clinicaltrials.gov no : NCT021683615 .

###25079942
BACKGROUND	Knowledge and skills of primary health care workers ( PHCWs ) in primary eye care have been demonstrated to be inadequate in several districts of Kenya , Malawi , and Tanzania .
BACKGROUND	We tested whether enhanced supervision , focused on improving practical skills over two years , would raise the scores of these workers on a test of basic knowledge and skills .
METHODS	This was a randomised controlled trial .
METHODS	All primary health care ( PHC ) facilities within two districts of each country were enrolled and randomly assigned by district ( Kenya , Malawi ) or by health care facility ( Tanzania ) to receive quarterly skills-based supervision by a district eye coordinator or to continue existing routine supervision .
METHODS	At baseline , a test of basic knowledge and skills in five key areas was administered to PHCWs , and visual acuity ( VA ) charts and working torches were provided .
METHODS	After two years the test was administered again .
METHODS	Changes in test scores were compared between the intervention ( enhanced supervision ) and the non-intervention ( routine supervision ) facilities .
RESULTS	All 137 facilities in the six districts were enrolled including 343 PHCWs .
RESULTS	At baseline , no facility had a visual acuity chart and 18 ( 13 % ) had a working torch ; the average total skills scores were 6.04 and 6.38 ( maximum of 12 ) in the non-intervention and the intervention facilities , respectively .
RESULTS	After two years , 16 intervention facilities ( 23.2 % ) had a visual acuity chart correctly placed and 19 ( 27.5 % ) had a working torch , compared to 4 ( 5.9 % ) and 6 ( 8.8 % ) , respectively , in the routine supervision facilities .
RESULTS	At the facility level , the change in overall test scores was +1.84 points in the intervention sites compared to +0.42 points in the non-intervention sites ( p < 0.001 ) .
RESULTS	Staff turnover included about 75 % of the staff by the end of the study .
CONCLUSIONS	The improvements in the enhanced supervision facilities were very modest and of questionable clinical significance .
CONCLUSIONS	The low impact of the intervention may be due to the high turnover of PHCWs or high absenteeism .
CONCLUSIONS	A better understanding of the quality of eye care at PHC facilities and influencing factors are urgently needed before continuing to invest resources in the scale up of this model of task shifting in Africa .

###25274713
BACKGROUND	Fall prevention is important for maintaining mobility and independence into old age .
BACKGROUND	Approaches for reducing falls include exercise , tai chi , and home modifications ; however , causes of falling are multifactorial and include not just physical but cognitive factors .
BACKGROUND	Cognitive decline occurs with age , but older adults with the greatest declines in executive function experience more falls .
BACKGROUND	The purpose of this study was twofold : to demonstrate the feasibility of a community-based cognitive training program for cognitively intact Black older adults and to analyze its impact on gait and balance in this population .
METHODS	This pilot study used a pretest/posttest randomized trial design with assignment to an intervention or control group .
METHODS	Participants assigned to the intervention completed a computer-based cognitive training class that met 2 days a week for 60 min over 10 weeks .
METHODS	Classes were held at senior/community centers .
METHODS	Primary outcomes included balance as measured by the Berg Balance Scale ( BBS ) , 10-meter gait speed , and 10-meter gait speed under visuospatial dual-task condition .
METHODS	All measures were assessed at baseline and immediately post-intervention .
RESULTS	Participants were community-dwelling Black adults with a mean age of 72.5 and history of falls ( N = 45 ) .
RESULTS	Compared to controls , intervention participants experienced statistically significant improvements in BBS and gait speed .
RESULTS	Mean performance on distracted gait speed also improved more for intervention participants compared to controls .
CONCLUSIONS	Findings from this pilot randomized trial demonstrate the feasibility of a community-based cognitive training intervention .
CONCLUSIONS	They provide initial evidence that cognitive training may be an efficacious approach toward improving balance and gait in older adults known to have a history of falls .

###25794201
BACKGROUND	The effectiveness of greater occipital nerve block ( GONB ) in patients with primary headache syndromes is controversial .
BACKGROUND	Few studies have been evaluated the usefulness of GONB in patients with migraine without aura ( MWOA ) .
OBJECTIVE	To compare the effectiveness of ultrasound-guided GONB using bupivacaine 0.5 % and placebo on clinical improvement in patients with refractory MWOA in a randomized , double-blinded clinical trial .
METHODS	A prospective , randomized , placebo-controlled , double-blind pilot trial .
METHODS	Physical medicine and rehabilitation and neurology departments of a University Hospital .
METHODS	Thirty-two patients with a diagnosis of MWOA according to the International Classification of Headache Disorders-II criteria were included in the study .
METHODS	Twenty-three patients ( 2 men , 21 women ) completed the study .
METHODS	They were randomly assigned to receive either GONB with local anesthetic ( bupivacaine 0.5 % 1.5 mL ) or greater occipital nerve ( GON ) injection with normal saline ( 0.9 % 1.5 mL ) .
METHODS	Ultrasound-guided GONB was performed to more accurately locate the nerve .
METHODS	All procedures were performed using a 7 - 13 MHz high-resolution linear ultrasound transducer .
METHODS	The treatment group was comprised of 11 patients and the placebo group was comprised of 12 patients .
METHODS	The primary outcome measure was the change in the headache severity score during the one-month post-intervention period .
METHODS	Headache severity was assessed with a visual analogue scale ( VAS ) from 0 ( no pain ) to 10 ( intense pain ) .
RESULTS	In both groups , a decrease in headache intensity on the injection side was observed during the first post-injection week and continued until the second week .
RESULTS	After the second week , the improvement continued in the treatment group , and the VAS score reached 0.97 at the end of the fourth week .
RESULTS	In the placebo group after the second week , the VAS values increased again and nearly reached the pre-injection levels .
RESULTS	The decrease in the monthly average pain intensity score on the injected side was statistically significant in the treatment group ( P = 0.003 ) , but not in the placebo group ( P = 0.110 ) .
RESULTS	No statistically significant difference in the monthly average pain intensity score was observed on the uninjected side in either group ( treatment group , P = 0.994 ; placebo group , P = 0.987 ) .
RESULTS	No serious side effect was observed after the treatment in either group .
RESULTS	Only one patient had a self-limited vaso-vagal syncope during the procedure .
CONCLUSIONS	This trial included a relatively small sample .
CONCLUSIONS	This may have been the result of the inclusion of only those patients who correctly completed their pain diaries .
CONCLUSIONS	Another major limitation is the short follow-up duration .
CONCLUSIONS	Patients were followed for one month after the injection , thus relatively long-term effects of the injection have not been observed .
CONCLUSIONS	Ultrasound guided GONB with 1.5 mL of 0.5 % bupivacaine for the treatment of migraine patients is a safe , simple , and effective technique without severe adverse effects .
CONCLUSIONS	To increase the effectiveness of the injection , and to implement the isolated GONB , ultrasonography guidance could be suggested .

###24805262
OBJECTIVE	X-linked retinitis pigmentosa is a severe inherited retinal degenerative disease with a frequency of 1 in 100,000 persons .
OBJECTIVE	Because no cure is available for this orphan disease and treatment options are limited , slowing of disease progression would be a meaningful outcome .
OBJECTIVE	To determine whether high-dose docosahexaenoic acid ( DHA ) , an -3 polyunsaturated fatty acid , slows progression of X-linked retinitis pigmentosa measured by cone electroretinography ( ERG ) .
METHODS	A 4-year , single-site , randomized , placebo-controlled , double-masked phase 2 clinical trial at a research center specializing in medical retina .
METHODS	Seventy-eight male patients diagnosed as having X-linked retinitis pigmentosa were randomized to DHA or placebo .
METHODS	Data were omitted for 2 patients with non-X-linked retinitis pigmentosa and 16 patients who were unable to follow protocol during the first year .
METHODS	The remaining participants were tested annually and composed a modified intent-to-treat cohort ( DHA group , n = 33 ; placebo group , n = 27 ) .
METHODS	All participants received a multivitamin and were randomly assigned to oral DHA ( 30 mg/kg/d ) or placebo .
METHODS	The primary outcome was the rate of loss of cone ERG function .
METHODS	Secondary outcomes were rod and maximal ERG amplitudes and cone ERG implicit times .
METHODS	Capsule counts and red blood cell DHA levels were assessed to monitor adherence .
RESULTS	Average ( 6-month to 4-year ) red blood cell DHA levels were 4-fold higher in the DHA group than in the placebo group ( P < .001 ) .
RESULTS	There was no difference between the DHA and placebo groups in the rate of cone ERG functional loss ( 0.028 vs 0.022 log V/y , respectively ; P = .30 ) .
RESULTS	No group differences were evident for change in rod ERG ( P = .27 ) , maximal ERG ( P = .65 ) , or cone implicit time ( no change over 4 years ) .
RESULTS	The rate of cone loss ( ie , event rate ) was markedly reduced compared with rates in previous studies .
RESULTS	No severe treatment-emergent adverse events were found .
CONCLUSIONS	Long-term DHA supplementation was not effective in slowing the loss of cone or rod ERG function associated with X-linked retinitis pigmentosa .
CONCLUSIONS	Participant dropout and lower-than-expected disease event rate limited power to detect statistical significance .
CONCLUSIONS	A larger sample size , longer trial , and attainment of a target blood DHA level ( 13 % ) would be desirable .
CONCLUSIONS	While DHA supplementation at 30 mg/kg/d does not present serious adverse effects , routine monitoring of gastrointestinal tolerance is prudent .
BACKGROUND	clinicaltrials.gov Identifier : NCT00100230 .

###24307311
OBJECTIVE	To investigate the effect of Chaiqin Chengqi Decoction ( , CQCQD ) on regulating serum matrix metalloproteinase 9 ( MMP-9 ) in patients with severe acute pancreatitis ( SAP ) .
METHODS	Thirty-five SAP patients hospitalized in West China Hospital from September 1 , 2008 to February 28 , 2009 were randomly assigned to two groups using a computer-derived random number sequence in a ratio of 1:1 , treatment group ( 18 patients ) and the placebo control group ( 17 patients ) .
METHODS	The patients in the treatment group were administered with CQCQD by gastric perfusion ( 50 mL/2 h ) and retention enema ( 200 mL/6 h ) for 7 days .
METHODS	The two groups had similar baseline information .
METHODS	The clinical indicators , including the initial Balthazar 's computed tomography ( CT ) score , acute physiology and chronic health evaluation II ( APACHE II ) scores on 1st , 3rd , 5th and 7th day , incidences and durations of complications and the serum C-reactive protein ( CRP ) , levels of MMP-9 on the 1st , 3rd , 5th and 7th day , were recorded and compared between the two groups .
RESULTS	The serum MMP-9 , CRP and the APACHE II scores on the 3rd , 5th and 7th day in the treatment group were lower than those in the control group ( P < 0.05 ) .
RESULTS	The serum MMP-9 was positively correlated with the APACHE II score on the 1st day ( r = 0.430 , P = 0.01 ) .
RESULTS	The durations of acute respiratory distress syndrome ( 5.42.4 vs. 2.91.3 ) , acute hepatitis ( 4.60.8 vs. 1.90.6 ) and acute heart failure ( 3.91.6 vs. 1.30.6 , < 0.05 ) in the control group were longer than those in the treatment group .
CONCLUSIONS	CQCQD could decrease the serum MMP-9 to relieve the severity of clinical symptoms and prevent the development of multiple organ dysfunction syndrome in patients with SAP .

###24356620
BACKGROUND	WSG-ARA plus trial evaluated the effect of adjuvant darbepoetin alfa ( DA ) on outcome in node positive primary breast cancer ( BC ) .
METHODS	One thousand two hundred thirty-four patients were randomized to chemotherapy either with DA ( DA + ; n = 615 ) or without DA ( DA - ; n = 619 ) .
METHODS	DA ( 500 g q3w ) was started at hemoglobin ( Hb ) levels < 13.0 g/dl ( < 12 g/dl after DA label amendment ) and stopped at Hb levels 14.0 g/dl ( 12 g/dl after label amendment ) .
METHODS	Primary efficacy end point was event-free survival ( EFS ) ; secondary end points were toxicity , quality of life ( QoL ) and overall survival ( OS ) .
RESULTS	Venous thrombosis ( DA + : 3.0 % , DA - : 1.0 % ; P = 0.013 ) was significantly higher for DA + , but not pulmonary embolism ( 0.3 % in both arms ) .
RESULTS	Median Hb levels were stable in DA + ( 12.6 g/dl ) and decreased in DA - ( 11.7 g/dl ) .
RESULTS	Hb levels > 15 g/dl were reported in 0.8 % of cycles .
RESULTS	QoL parameters did not significantly differ between arms .
RESULTS	At 39 months , DA had no significant impact on EFS ( DA + : 89.3 % , DA - : 87.5 % ; Plog-rank = 0.55 ) or OS ( DA + : 95.5 % , DA - : 95.4 % ; Plog-rank = 0.77 ) .
CONCLUSIONS	DA treatment did not impact EFS or OS in routine adjuvant BC treatment .

###24617225
OBJECTIVE	To observe clinical therapeutic effects of acupuncture for pattern of liver-stagnation and spleen-deficiency in diarrhea-predominant irritable bowel syndrome ( D-IBS ) and its impact on cell factors .
METHODS	Forty cases were selected and divided into an acupuncture group ( 21 cases ) in which acupuncture was applied and a medicine group ( 19 cases ) in which oral administration of dicetel and bifidobacterium lactobacillus triple viable capsules were applied .
METHODS	The symptom scores , level of Th1-type cytokine ( IFN-gamma , IL-2 ) and Th2-type cytokine ( IL-4 , IL-10 ) and ratio of IFN-gamma to IL-4 were compared in two groups before and after treatment to analyze acupuncture effect .
RESULTS	The clinical symptoms were improved after one-week treatment in the acupuncture group ( P < 0.05 ) , which had faster onset than the medicine group ( P < 0.05 ) .
RESULTS	The total effective rate was 90.48 % ( 19/21 ) in the acupuncture group , which was superior to 78.95 % ( 15/19 ) in the medicine group ( P < 0.05 ) .
RESULTS	Compared with medicine treatment , imbalanced condition of Th1/Th2 was turning towards the direction of Th2 after acupuncture , indicating a tendency to recover the balance .
CONCLUSIONS	The clinical efficacy of acupuncture for D-IBS has close relationship with effectively improving balance of Th1/Th2 in patients with liver-stagnation and spleen-deficiency .

###24842847
BACKGROUND	The advanced life support guidelines recommend 2min of cardiopulmonary resuscitation ( CPR ) and minimal hands-off time to ensure sufficient cardiac and cerebral perfusion .
BACKGROUND	We have observed doctors who shorten the CPR intervals during resuscitation attempts .
BACKGROUND	During simulation-based resuscitation training , the recommended 2-min CPR cycles are often deliberately decreased in order to increase the number of scenarios .
BACKGROUND	The aim of this study was to test if keeping 2-min CPR cycles during resuscitation training ensures better adherence to time during resuscitation in a simulated setting .
METHODS	This study was designed as a randomised control trial .
METHODS	Fifty-four 4th-year medical students with no prior advanced resuscitation training participated in an extra-curricular one-day advanced life support course .
METHODS	Participants were either randomised to simulation-based training using real-time ( 120s ) or shortened CPR cycles ( 30-45s instead of 120s ) in the scenarios .
METHODS	Adherence to time was measured using the European Resuscitation Council 's Cardiac Arrest Simulation Test ( CASTest ) in retention tests conducted one and 12 weeks after the course .
RESULTS	The real-time group adhered significantly better to the recommended 2-min CPR cycles ( time-120s ) ( mean 13 ; standard derivation ( SD ) 8 ) than the shortened CPR cycle group ( mean 45 ; SD 19 ) when tested ( p < 0.001 . )
CONCLUSIONS	This study indicates that time is an important part of fidelity .
CONCLUSIONS	Variables critical for performance , like adherence to time in resuscitation , should therefore be kept realistic during training to optimise outcome .

###25825948
BACKGROUND	Weight loss is associated with reduction in bone mineral density ( BMD ) .
OBJECTIVE	The objective was to address the role of changes in fat mass ( FM ) and lean mass ( LM ) in BMD decline in both sexes .
METHODS	A 2-year randomized controlled trial , the Preventing Overweight Using Novel Dietary Strategies ( POUNDS-LOST ) .
METHODS	The setting was the general community .
METHODS	Enrolled were 424 overweight and obese participants ( mean age , 52 9 y ; 57 % females ) .
METHODS	Intervention included weight loss diets differing in fat , protein , and carbohydrates .
METHODS	Main outcome measures were change in spine , total hip ( TH ) , and femoral neck ( FN ) BMD and sex differences after dietary intervention .
RESULTS	At baseline , a stronger correlation between BMD and body composition measurements was observed in women , primarily with LM ( r = 0.419 , 0.507 , and 0.523 for spine , FN , and TH , respectively ; all P < .001 ) .
RESULTS	In men , only LM correlated with hip BMD ( r = 0.298 ; P < .001 ) .
RESULTS	Mean weight loss at 2 years was -6.9 % , without differences among diets .
RESULTS	Two-year changes in BMD were 0.005 ( P = .04 ) , -0.014 ( P < .001 ) , and -0.014 g/cm ( 2 ) ( P < .001 ) , at the spine , TH , and FN , respectively .
RESULTS	These changes directly correlated with changes in LM in women ( r = 0.200 , 0.324 , and 0.260 for spine , FN , and TH , respectively ) , whereas FM loss correlated only with changes in TH BMD ( 0.274 ; P < .001 ) .
RESULTS	In men , changes in LM ( -0.323 ; P < .001 ) and FM ( -0.213 ; P = .027 ) negatively correlated with changes in spine BMD .
CONCLUSIONS	Weight loss diets result in sex-specific effects on BMD .
CONCLUSIONS	Although men exhibited a paradoxical increase in spine BMD , women tended to decrease in BMD at all sites .

###25025522
OBJECTIVE	Determine whether a church-based social marketing program increases older adults ' participation in balance classes for fall prevention .
METHODS	In 2009-10 , 51 churches ( 7101 total members aged 60 ) in Colorado , U.S.A. were randomized to receive no intervention or a social marketing program .
METHODS	The program highlighted benefits of class participation ( staying independent , building relationships ) , reduced potential barriers ( providing convenient , subsidized classes ) , and communicated marketing messages through church leaders , trained `` messengers , '' printed materials and church-based communication channels .
METHODS	Between-group differences in balance class enrollment and marketing message recall among congregants were compared using Wilcoxon Two-Sample Test and regression models .
RESULTS	Compared to 25 control churches , 26 churches receiving the social marketing program had a higher median proportion ( 9.8 % vs. 0.3 % ; p < 0.001 ) and mean number ( 7.0 vs. 0.5 ; IRR = 11.2 [ 95 % CI : 7.5 , 16.8 ] ) of older adult congregants who joined balance classes .
RESULTS	Intervention church members were also more likely to recall information about preventing falls with balance classes ( AOR = 6.2 ; 95 % CI : 2.6 , 14.8 ) and availability of classes locally ( AOR = 7.7 ; 95 % CI : 2.6 , 22.9 ) .
CONCLUSIONS	Church-based social marketing effectively disseminated messages about preventing falls through balance classes and , by emphasizing benefits and reducing barriers and costs of participation , successfully motivated older adults to enroll in the classes .

###24898240
BACKGROUND	Low serum 25-hydroxyvitamin D [ 25 ( OH ) D ] concentrations have been associated with insulin resistance , the metabolic syndrome , and type 2 diabetes .
BACKGROUND	Because many non-Western immigrants in the Netherlands are vitamin D deficient , obese , and at high risk of diabetes , vitamin D supplementation may contribute to prevent diabetes and insulin resistance .
OBJECTIVE	We examined the effect of vitamin D supplementation on insulin sensitivity and cell function in overweight , vitamin D-deficient , non-Western immigrants at high risk of diabetes .
METHODS	The study was a 16-wk , randomized , placebo-controlled trial .
METHODS	A total of 130 non-Western immigrants with prediabetes ( fasting glucose concentration > 5.5 mmol/L or random glucose concentration from 7.8 to 11.1 mmol/L ) and vitamin D deficiency ( serum 25 [ OH ] D concentration < 50 nmol/L ) were randomly assigned after stratification by sex to receive either cholecalciferol ( 1200 IU/d ) or a placebo for 16 wk .
METHODS	All participants received 500 mg Ca/d as calcium carbonate .
METHODS	The primary outcome was the difference in the area under the curve of insulin and glucose after a 75-g oral-glucose-tolerance test after 4 mo of treatment .
METHODS	Secondary outcomes were insulin-sensitivity variables , cell-function variables , and metabolic syndrome .
RESULTS	Mean serum 25 ( OH ) D concentrations increased significantly in the vitamin D compared with placebo groups .
RESULTS	After 4 mo of therapy , the mean between-group difference was 38 nmol/L ( 95 % CI : 32.1 , 43.9 nmol/L ; P < 0.001 ) .
RESULTS	There was no significant effect on insulin sensitivity and cell function .
RESULTS	In a post hoc analysis , when patients with diabetes at baseline were excluded , a significant increase in the insulinogenic index was observed in participants who obtained a 25 ( OH ) D concentration 60 nmol/L ( P = 0.040 ) .
CONCLUSIONS	Vitamin D supplementation in non-Western vitamin D-deficient immigrants with prediabetes did not improve insulin sensitivity or cell function or change the incidence of metabolic syndrome .
CONCLUSIONS	However , after the exclusion of diabetic subjects , an improvement in the insulinogenic index was observed in participants who obtained a 25 ( OH ) D concentration 60 nmol/L .
CONCLUSIONS	This trial was registered at trialregister.nl as NTR1827 .

###24633138
BACKGROUND	Unilateral spatial neglect ( USN ) is a visual-perceptual disorder that entails the inability to perceive and integrate stimuli on one side of the body , resulting in the neglect of one side of the body .
BACKGROUND	Stroke patients with USN present with extensive functional disability and duration of therapy input .
OBJECTIVE	To determine the effect of saccadic eye movement training with visual scanning exercises ( VSEs ) integrated with task-specific activities on USN poststroke .
METHODS	A matched-pair randomized control trial was conducted .
METHODS	Subjects were matched according to their functional activity level and allocated to either a control ( n = 12 ) or an experimental group ( n = 12 ) .
METHODS	All patients received task-specific activities for a 4-week intervention period .
METHODS	The experimental group received saccadic eye movement training with VSE integrated with task specific activities as an `` add on '' intervention .
METHODS	Assessments were conducted weekly over the intervention period .
RESULTS	Statistical significant difference was noted on the King-Devick Test ( P = .021 ) , Star Cancellation Test ( P = .016 ) , and Barthel Index ( P = .004 ) .
CONCLUSIONS	Intensive saccadic eye movement training with VSE integrated with task-specific activities has a significant effect on USN in patients poststroke .
CONCLUSIONS	Results of this study are supported by findings from previously reviewed literature in the sense that the effect of saccadic eye movement training with VSE as an intervention approach has a significant effect on the visual perceptual processing of participants with USN poststroke .
CONCLUSIONS	The significant improved visual perceptual processing translate to significantly better visual function and ability to perform activities of daily living following the stroke .

###24893311
OBJECTIVE	In this study we used nationwide population based data to compare perioperative outcomes , including severe bladder injury , between monopolar andbipolar transurethral resection of bladder tumors .
METHODS	Data of patients with clinical T2 or less bladder cancer who underwent monopolar or bipolar transurethral bladder tumor resection were collected from 788 hospitals in the Japanese Diagnosis Procedure Combination database 2007-2012 .
METHODS	One-to-one propensity score matching was performed .
METHODS	End points assessed were severe bladder injury requiring placement ofadrainage tube or repair surgery within 3 postoperative days , hemostasis procedures consisting of clot removal or transurethral coagulation within 3postoperative days , transfusion , other complications , anesthesia duration , postoperative length of stay and total costs .
METHODS	Multivariate analyses compared outcomes of bipolar and monopolar transurethral bladder tumor resection with gender , age , Charlson comorbidity index , clinical stage , hospital volume and hospital academic status as covariates .
RESULTS	A total of 8,188 pairs were generated .
RESULTS	Compared with monopolar transurethral bladder tumor resection , bipolar resection was associated with a significantly lower incidence of severe bladder injury ( 0.3 % vs 0.6 % , OR 0.57 ) , other complications ( 4.6 % vs 5.8 % , OR 0.78 ) , slightly shorter postoperative stay ( mean 6.4 vs 6.7 days , difference -3.3 % ) and slightly lower total costs ( mean $ 4,628 vs $ 4,727 ; difference -1.1 % , all p < 0.05 ) .
RESULTS	There were no differences in postoperative hemostasis procedures , transfusion and anesthesia duration .
CONCLUSIONS	Bipolar transurethral bladder tumor resection was associated with a substantially lower incidence of several perioperative complications including severe bladder injury .
CONCLUSIONS	The findings support the benefit of bipolar transurethral bladder tumor resection over monopolar resection in real-world clinical practice .

###25251800
OBJECTIVE	To examine effects of a rowing exercise regimen versus a chest physical therapy program on pulmonary function in children with Down syndrome .
METHODS	Twenty-nine participants of both sexes , between 8 to 12 years of age , participated in this study .
METHODS	They were assigned randomly into 2 study groups .
METHODS	The first group ( A ) received a chest physical therapy program , while the second group ( B ) received an aerobic exercise regimen using a rowing ergometer .
METHODS	Vital capacity , forced vital capacity , forced expiratory volume after 1 second , and peak expiratory flow rate were measured before and after 12 successive weeks of treatment .
RESULTS	Significant improvements in all measured variables were found posttreatment in both study groups .
RESULTS	No significant difference between the 2 groups was found posttreatment .
CONCLUSIONS	Rowing exercise could be effective in improving pulmonary functions in children with Down syndrome .

###26116315
BACKGROUND	A systematic assessment of potential disease-modifying compounds for Parkinson 's disease concluded that pioglitazone could hold promise for the treatment of patients with this disease .
BACKGROUND	We assessed the effect of pioglitazone on the progression of Parkinson 's disease in a multicentre , double-blind , placebo-controlled , futility clinical trial .
METHODS	Participants with the diagnosis of early Parkinson 's disease on a stable regimen of 1 mg/day rasagiline or 10 mg/day selegiline were randomly assigned ( 1:1:1 ) to 15 mg/day pioglitazone , 45 mg/day pioglitazone , or placebo .
METHODS	Investigators were masked to the treatment assignment .
METHODS	Only the statistical centre and the central pharmacy knew the treatment name associated with the randomisation number .
METHODS	The primary outcome was the change in the total Unified Parkinson 's Disease Rating Scale ( UPDRS ) score between the baseline and 44 weeks , analysed by intention to treat .
METHODS	The primary null hypothesis for each dose group was that the mean change in UPDRS was 3 points less than the mean change in the placebo group .
METHODS	The alternative hypothesis ( of futility ) was that pioglitazone is not meaningfully different from placebo .
METHODS	We rejected the null if there was significant evidence of futility at the one-sided alpha level of 010 .
METHODS	The study is registered at ClinicalTrials.gov , number NCT01280123 .
RESULTS	210 patients from 35 sites in the USA were enrolled between May 10 , 2011 , and July 31 , 2013 .
RESULTS	The primary analysis included 72 patients in the 15 mg group , 67 in the 45 mg group , and 71 in the placebo group .
RESULTS	The mean total UPDRS change at 44 weeks was 442 ( 95 % CI 255-628 ) for 15 mg pioglitazone , 513 ( 95 % CI 317-708 ) for 45 mg pioglitazone , and 625 ( 95 % CI 435-815 ) for placebo ( higher change scores are worse ) .
RESULTS	The mean difference between the 15 mg and placebo groups was -183 ( 80 % CI -356 to -010 ) and the null hypothesis could not be rejected ( p = 019 ) .
RESULTS	The mean difference between the 45 mg and placebo groups was -112 ( 80 % CI -293 to 069 ) and the null hypothesis was rejected in favour of futility ( p = 009 ) .
RESULTS	Planned sensitivity analyses of the primary outcome , using last value carried forward ( LVCF ) to handle missing data and using the completers ' only sample , suggested that the 15 mg dose is also futile ( p = 009 for LVCF , p = 009 for completers ) but failed to reject the null hypothesis for the 45 mg dose ( p = 012 for LVCF , p = 019 for completers ) .
RESULTS	Six serious adverse events occurred in the 15 mg group , nine in the 45 mg group , and three in the placebo group ; none were thought to be definitely or probably related to the study interventions .
CONCLUSIONS	These findings suggest that pioglitazone at the doses studied here is unlikely to modify progression in early Parkinson 's disease .
CONCLUSIONS	Further study of pioglitazone in a larger trial in patients with Parkinson 's disease is not recommended .
BACKGROUND	National Institute of Neurological Disorders and Stroke .

###24986062
BACKGROUND	Compared with adults without type 2 diabetes mellitus , those with the disease experience more limitations in their physical functioning ( PF ) .
BACKGROUND	Look AHEAD is a large multicenter trial that examined the effects of an intensive lifestyle intervention ( ILI ) for weight loss on cardiovascular outcomes compared with diabetes support and education ( DSE ) .
BACKGROUND	Although the current study compared treatment differences between ILI and DSE on PF , the primary goal was to examine whether this effect was moderated by age and history of cardiovascular disease at enrollment .
METHODS	Overweight or obese adults with type 2 diabetes mellitus ( n = 5,145 ) were randomly assigned to either ILI or DSE .
METHODS	The mean ( SD ) age and % females in ILI was 58.9 years ( 6.9 ) and 59.8 % ; it was 58.6 years ( 6.8 ) and 59.5 % in DSE .
METHODS	Analysis in 4,998 participants assessed the differential rates of decline in PF across a period of 8 years for the ILI and DSE groups .
RESULTS	ILI resulted in improved PF compared with DSE after 1 year ( p < .0001 ) and was maintained across time .
RESULTS	Within the ILI , older adults experienced greater improvements than younger adults ( p < .0001 ) .
RESULTS	By year 2 , persons in ILI with preexisting cardiovascular disease were no different in PF than in DSE participants with preexisting cardiovascular disease .
CONCLUSIONS	With the exception of persons who had a history of cardiovascular disease , ILI slowed the decline in PF with type 2 diabetes mellitus despite weight regain , an effect that was stronger for older than younger participants and could translate into reductions in falls and disability .

###24961960
BACKGROUND	Flexible laryngeal mask airway is a commonly used supraglotic airway device ( SAD ) during ophthalmic surgeries .
BACKGROUND	Air-Q intubating laryngeal airway ( ILA ) is a newer SAD used as primary airway device and as a conduit for intubation as well .
BACKGROUND	Available literature shows that air-Q performs equal or better than other SADs in children and adults .
BACKGROUND	However , limited data is available using air-Q in infants and small children < 10 kg .
BACKGROUND	So , our aim was To compare the performance and efficacy of these two devices in infants and small children .
BACKGROUND	Our hypothesis is that air-Q due to its improved cuff design will yield better airway seal pressures and improved laryngeal alignment as compared to flexible laryngeal mask airway .
METHODS	ASA III infants and children weighing < 10 kg , undergoing cataract or glaucoma surgery , were randomly divided into two groups of 25 each .
METHODS	After induction of anesthesia and muscle relaxation , we measured oropharyngeal leak pressure ( OLP ) , fibre-optic ( FO ) view of glottis , first insertion success rate , time to insert , and any other complications .
RESULTS	There was no difference between the groups in demographic data , first insertion success rate , time to insert , and postoperative complications .
RESULTS	Air-Q provided significantly more OLP [ 21.1 6.4 cmH2O vs 17.4 4.1 cmH2O , P = 0.02 ] and better FO view of glottis ( good view 84 % vs 48 % , P = 0.0016 ) as compared to flexible laryngeal mask airway .
CONCLUSIONS	We conclude that air-Q is superior to flexible laryngeal mask airway in providing higher airway sealing pressures and better FO grade of laryngeal view in infants and children .

###25397825
BACKGROUND	Initial posttraumatic stress disorder ( PTSD ) care is often delayed and many with PTSD go untreated .
BACKGROUND	Acupuncture appears to be a safe , potentially nonstigmatizing treatment that reduces symptoms of anxiety , depression , and chronic pain , but little is known about its effect on PTSD .
METHODS	Fifty-five service members meeting research diagnostic criteria for PTSD were randomized to usual PTSD care ( UPC ) plus eight 60-minute sessions of acupuncture conducted twice weekly or to UPC alone .
METHODS	Outcomes were assessed at baseline and 4 , 8 , and 12 weeks postrandomization .
METHODS	The primary study outcomes were difference in PTSD symptom improvement on the PTSD Checklist ( PCL ) and the Clinician-administered PTSD Scale ( CAPS ) from baseline to 12-week follow-up between the 2 treatment groups .
METHODS	Secondary outcomes were depression , pain severity , and mental and physical health functioning .
METHODS	Mixed model regression and t test analyses were applied to the data .
RESULTS	Mean improvement in PTSD severity was significantly greater among those receiving acupuncture than in those receiving UPC ( PCL = 19.813.3 vs. 9.712.9 , P < 0.001 ; CAPS = 35.020.26 vs. 10.920.8 , P < 0.0001 ) .
RESULTS	Acupuncture was also associated with significantly greater improvements in depression , pain , and physical and mental health functioning .
RESULTS	Pre-post effect-sizes for these outcomes were large and robust .
CONCLUSIONS	Acupuncture was effective for reducing PTSD symptoms .
CONCLUSIONS	Limitations included small sample size and inability to parse specific treatment mechanisms .
CONCLUSIONS	Larger multisite trials with longer follow-up , comparisons to standard PTSD treatments , and assessments of treatment acceptability are needed .
CONCLUSIONS	Acupuncture is a novel therapeutic option that may help to improve population reach of PTSD treatment .

###25233656
OBJECTIVE	To observe the clinical efficacy of acupuncture at Hegu ( LI 4 ) on central facial nerve paralysis after ischemic stroke , and explore dose-effect relationship among different stimulation intensities of acupuncture at Hegu ( LI 4 ) as well as its optimal treatment plan .
METHODS	According to different acupuncture stimulation intensities which were based on treatment time and needle insertion direction , fifty patients were randomly divided into a Hegu 1 group , a Hegu 2 group , a Hegu 3 group , a Hegu 4 group and a control group , ten cases in each one .
METHODS	Different stimulation intensities of acupuncture at Hegu ( LI 4 ) combined with facial paralysis acupoints , including Yingxiang ( LI 20 ) , Dicang ( ST 4 ) , Jiache ( ST 6 ) and Quanliao ( SI 18 ) , were applied in Hegu 1 to 4 groups ; meanwhile acupuncture at stroke acupoints , including Neiguan ( PC 6 ) , Shuigou ( GV 26 ) and Sanyinjiao ( SP 6 ) , and medication treatment were adopted .
METHODS	Except acupuncture at Hegu ( LI 4 ) , the treatment of the control group was identical as Hegu groups .
METHODS	The treatment duration lasted for 14 days .
METHODS	The House-Brackmann facial never grading systems ( H-B ) , Toronto facial grading system ( TFGS ) , degrees of facial never paralysis ( DFNP ) , facial disability index ( FDI ) and clinical efficacy were compared among groups .
RESULTS	( 1 ) Compared before the treatment , H-B , TFGS , DFNP and physical function score in FDI were all improved significantly in the Hegu 1 to 4 groups ( all P < 0.05 ) , but social function score in FDI was not obviously improved ( all P > 0.05 ) ; all the scores in the control group were not evidently changed ( all P > 0.05 ) .
RESULTS	( 2 ) Compared with the control group , differences of H-B before and after treatment in the Hegu 1 to 4 groups , differences of TFGS in the Hegu 2 group and differences of DFNP in the Hegu 1 and Hegu 2 group were significantly improved ( all P < 0.05 ) .
RESULTS	The differences of any scale among Hegu 1 to 4 groups were not significant ( all P > 0.05 ) , in which the most evident change was found in Hegu 2 group .
RESULTS	( 3 ) The total effective rate was 90.0 % ( 9/10 ) , 100.0 % ( 10/10 ) , 90.0 % ( 9/10 ) and 80.0 % ( 8/10 ) in Hegu 1 to 4 groups , which were significantly higher than 60.0 % ( 6/10 ) in the control group ( all P < 0.05 ) .
CONCLUSIONS	Acupuncture at Hegu ( LI 4 ) has affirmative clinical efficacy on central facial nerve paralysis after ischemic stroke , in which oblique insertion along the opposite direction of meridian for 5 s of twirling manipulation has the best clinical effect .

###25403218
OBJECTIVE	Internet support group ( ISG ) members benefit from receiving social support and , according to the helper therapy principle , by providing support to others .
OBJECTIVE	To test the mental health benefits of providing support to others , this trial compared the efficacy of a standard ISG ( S-ISG ) and an enhanced prosocial ISG ( P-ISG ) .
METHODS	A two-armed randomized controlled trial with 1-month pretest and post-test assessments was conducted with women ( N = 184 ) diagnosed in the past 36 months with nonmetastatic breast cancer who reported elevated anxiety or depression .
METHODS	Women were randomly assigned to either the S-ISG or P-ISG condition .
METHODS	Both conditions included six professionally facilitated live chat sessions ( 90-minute weekly sessions ) and access to an asynchronous discussion board ; P-ISG also included structured opportunities to help and encourage others .
RESULTS	Relative to the S-ISG , participants in the P-ISG condition exhibited more supportive behaviors ( emotional , informational , and companionate support ) , posted more messages that were other-focused and fewer that were self-focused , and expressed less negative emotion ( P < .05 ) .
RESULTS	Relative to the S-ISG , participants in the P-ISG condition had a higher level of depression and anxiety symptoms after the intervention ( P < .05 ) .
CONCLUSIONS	Despite the successful manipulation of supportive behaviors , the P-ISG did not produce better mental health outcomes in distressed survivors of breast cancer relative to an S-ISG .
CONCLUSIONS	The prosocial manipulation may have inadvertently constrained women from expressing their needs openly , and thus , they may not have had their needs fully met in the group .
CONCLUSIONS	Helping others may not be beneficial as a treatment for distressed survivors of breast cancer .

###24528999
BACKGROUND	Polychlorinated biphenyls ( PCBs ) and dioxin given to experimental animals increase the blood pressure .
BACKGROUND	We therefore investigated if circulating levels of persistent organic pollutants ( POPs ) were related to hypertension in a population-based sample of men and women .
METHODS	One thousand and sixteen subjects aged 70 years were investigated in the Prospective Investigation of the Vasculature in Uppsala Seniors ( PIVUS ) study .
METHODS	Twenty-three POPs were analyzed using high-resolution gas chromatography/high-resolution mass spectrometry ( HRGC/HRMS ) .
METHODS	Hypertension was defined as a systolic blood pressure 140mmHg or a diastolic blood pressure 90mmHg , and/or use of antihypertensive medication .
RESULTS	Seven hundred and thirty-two subjects ( 72 % ) showed hypertension .
RESULTS	When the POPs were treated as continuous variables and adjusted for gender only , two PCBs with a low number of chlorine atoms ( PCB 105 and 118 ) were related to prevalent hypertension .
RESULTS	Also the OC pesticide p , p ' - DDE was related to hypertension .
RESULTS	The strongest of these associations was seen for p , p ' - DDE ( OR 1.35 for a 1 SD change , 95 % CI 1.17-1 .56 , p < 0.0001 ) .
RESULTS	Following further adjustment also for BMI , smoking status , education level and exercise habits , only p , p ' - DDE was still significantly related to hypertension ( OR 1.23 for a 1 SD change , 95 % CI 1.06-1 .43 , p = 0.006 ) .
CONCLUSIONS	In this cross-sectional analysis of an elderly population , high levels of circulating levels of p , p ' - DDE were associated with prevalent hypertension , further strengthening the experimental findings that POPs might influence blood pressure .

###24503231
OBJECTIVE	To compare the effectiveness of buddy strapping and aluminum orthosis for treatment of proximal interphalangeal ( PIP ) joint hyperextension injuries .
OBJECTIVE	We also evaluated the effect of age on the outcome by comparing our results in adults and children .
METHODS	One hundred twenty-one consecutive patients with a PIP joint hyperextension injury of the index , middle , ring , or little finger and without fracture were evaluated .
METHODS	Patients were randomly assigned into 2 groups .
METHODS	In the first group , treatment included buddy strapping of the injured finger to its neighbor noninjured finger for a week .
METHODS	In the second group , immobilization was secured with an aluminum extension blocking orthosis for a week in 15 flexion .
METHODS	Assessment of motion , edema , pain , and strength were performed weekly for the first month and then at 3 , 6 , and 12 months after injury .
RESULTS	The patients treated with buddy strapping exhibited similar outcomes compared with those treated with aluminum orthoses .
RESULTS	In patients with full recovery , buddy strapping allowed earlier recovery of motion and resolution of edema and pain compared with aluminum orthosis immobilization .
RESULTS	Furthermore , PIP injuries appear to have better outcomes in children than in adults .
CONCLUSIONS	Buddy strapping is easy and effective treatment for PIP joint hyperextension injuries .
METHODS	Therapeutic I.

###25308155
OBJECTIVE	Approximately 20 % of newborns infants need respiratory support at birth .
OBJECTIVE	This study evaluated whether video-based education could improve quality of positive pressure ventilation ( PPV ) performed by inexperienced staff during neonatal resuscitation .
METHODS	Fourth-year medical students were randomly paired and instructed to give PPV to a modified manikin as single-person resuscitators and as two-person-paired resuscitators using either an air cushion rim mask or a round mask before and after watching a self-instructional video .
METHODS	Airway pressure , gas flow , tidal volume and mask leak were recorded .
METHODS	PPV performance quality was analysed using video recording .
RESULTS	Mask leak was lower during one-person ventilation when using the air cushion rim mask ( 56 16 % ) compared to the round mask ( 71 19 % ) .
RESULTS	Round mask leak during one-person ventilation was significantly lower when using the two point top hold in contrast to the ` o.k. ' rim hold ( before training : 63 22 % vs. 72 18 % , after training : 57 17 % vs. 77 12 % ) .
RESULTS	Watching a self-instructional video improved performance quality scores of both correct head positioning , and the quality of airway manoeuvres compared to baseline , however mask leak was not significantly reduced .
CONCLUSIONS	A self-instructional video significantly improved bag mask PPV performance in inexperienced providers but did not improve mask leak in a model of neonatal resuscitation .

###25262458
BACKGROUND	Internet-based interventions for smoking cessation could help millions of people stop smoking at very low unit costs ; however , long-term biochemically verified evidence is scarce and such interventions might be less effective for smokers with low socioeconomic status than for those with high status because of lower online literacy to engage with websites .
BACKGROUND	We aimed to assess a new interactive internet-based intervention ( StopAdvisor ) for smoking cessation that was designed with particular attention directed to people with low socioeconomic status .
METHODS	We did this online randomised controlled trial between Dec 6 , 2011 , and Oct 11 , 2013 , in the UK .
METHODS	Participants aged 18 years and older who smoked every day were randomly assigned ( 1:1 ) to receive treatment with StopAdvisor or an information-only website .
METHODS	Randomisation was automated with an unseen random number function embedded in the website to establish which treatment was revealed after the online baseline assessment .
METHODS	Recruitment continued until the required sample size had been achieved from both high and low socioeconomic status subpopulations .
METHODS	Participants , and researchers who obtained data and did laboratory analyses , were masked to treatment allocation .
METHODS	The primary outcome was 6 month sustained , biochemically verified abstinence .
METHODS	The main secondary outcome was 6 month , 7 day biochemically verified point prevalence .
METHODS	Analysis was by intention to treat .
METHODS	Homogeneity of intervention effect across the socioeconomic subsamples was first assessed to establish whether overall or separate subsample analyses were appropriate .
METHODS	The study is registered as an International Standard Randomised Controlled Trial , number ISRCTN99820519 .
RESULTS	We randomly assigned 4613 participants to the StopAdvisor group ( n = 2321 ) or the control group ( n = 2292 ) ; 2142 participants were of low socioeconomic status and 2471 participants were of high status .
RESULTS	The overall rate of smoking cessation was similar between participants in the StopAdvisor and control groups for the primary ( 237 [ 10 % ] vs 220 [ 10 % ] participants ; relative risk [ RR ] 106 , 95 % CI 089-127 ; p = 049 ) and the secondary ( 358 [ 15 % ] vs 332 [ 15 % ] participants ; 106 , 093-122 ; p = 037 ) outcomes ; however , the intervention effect differed across socioeconomic status subsamples ( 144 , 099-209 ; p = 00562 and 137 , 102-184 ; p = 00360 , respectively ) .
RESULTS	StopAdvisor helped participants with low socioeconomic status stop smoking compared with the information-only website ( primary outcome : 90 [ 8 % ] of 1088 vs 64 [ 6 % ] of 1054 participants ; RR 136 , 95 % CI 100-186 ; p = 00499 ; secondary outcome : 136 [ 13 % ] vs 100 [ 10 % ] participants ; 132 , 103-168 , p = 00267 ) , but did not improve cessation rates in those with high socioeconomic status ( 147 [ 12 % ] of 1233 vs 156 [ 13 % ] of 1238 participants ; 095 , 077-117 ; p = 061 and 222 [ 18 % ] vs 232 [ 19 % ] participants ; 096 , 081-113 , p = 064 , respectively ) .
CONCLUSIONS	StopAdvisor was more effective than an information-only website in smokers of low , but not high , socioeconomic status .
CONCLUSIONS	StopAdvisor could be implemented easily and made freely available , which would probably improve the success rates of smokers with low socioeconomic status who are seeking online support .
BACKGROUND	National Prevention Research Initiative .

###24427769
BACKGROUND	The efficiency of inhibitory pain descending pathways ( evaluated using conditioned pain modulation [ CPM ] ) has not been studied in postherpetic neuralgia ( PHN ) .
OBJECTIVE	To compare CPM in PHN patients with healthy controls .
METHODS	Nine PHN patients and nine control individuals were matched according to age and sex .
METHODS	Amplitudes of cortical thermal-evoked potentials were recorded on the surface of the scalp ; clinical pain and thermal pain were evaluated on a 0 to 10 numerical rating scale , at baseline and at intervals during the 6 min after CPM ( elicited by a cold pressor test , 8C ) .
METHODS	A battery of cognitive tests was performed .
METHODS	Amplitude differences , percentages and related areas under the curve ( AUC <span style="vertical-align: sub"> CPM <span> ) were calculated and all data were compared between both groups ; P < 0.05 was considered to be statistically significant .
RESULTS	AUC <span style="vertical-align: sub"> CPM0-6 min <span> was significantly lower in PHN patients compared with controls ( -3951 Vmin versus -14466 Vmin ; P = 0.0012 ) and correlated ( P = 0.04 ) with clinical pain intensity .
RESULTS	Pain ratings before CPM were similar in both groups but were significantly lower in the control group 3 min after the cold pressor test .
RESULTS	Cognitive test results were not significantly different .
CONCLUSIONS	Psychophysical and electrophysiological approaches have shown that patients with PHN exhibit a deficiency of pain inhibition modulation , which could signal a predisposing factor to developing chronic pain .
CONCLUSIONS	This deficiency was not linked to the cognitive performance but rather to subtle in situ cognitivoemotional adaptations , which remain to be investigated .

###25688602
OBJECTIVE	To present detailed adverse event ( AE ) data from a randomized controlled trial ( RCT ) of a home-based exercise program delivered to an elderly high-risk population by an exercise therapist after medical clearance from a general practitioner ( GP ) .
METHODS	Randomized controlled trial .
METHODS	General practitioner practices and participant homes .
METHODS	Community-dwelling , chronically ill , mobility-limited individuals aged 70 and older ( mean 80 5 ) participating in a RCT of an exercise program ( HOMEfit ; ISRCTN17727272 ) ( N = 209 ; n = 106 experimental , n = 103 control ; 74 % female ) .
METHODS	A 12-week multidimensional home-based exercise program ( experimental ) versus baseline physical activity counseling ( control ) .
METHODS	An exercise therapist delivered both interventions to participants during counseling sessions at the GP 's practice and on the telephone .
METHODS	Adverse events were documented at least at every counseling session and assessed by the GP and an AE manager .
RESULTS	One hundred fifty-one AEs were reported in 47 % ( n = 99 ) of all participants .
RESULTS	Twenty-one ( 14 % ) events were classified as serious .
RESULTS	In six events ( 4 % ; n = 4 experimental , n = 2 control ) , participation in the study had to be discontinued immediately .
RESULTS	In 25 events ( 17 % ; n = 9 experimental , n = 16 control ) , the intervention had to be suspended .
RESULTS	The intervention was determined to have caused two events ( both nonserious and in the experimental group ) .
CONCLUSIONS	Even though the program appears to be safe , high morbidity unrelated to exercise can constitute a critical challenge for sustained exercise participation .

###25131034
BACKGROUND	Candidates for liver transplantation may have malnutrition , fatigue , loss of muscle mass and function .
BACKGROUND	The combination of these factors leads to overall physical disability and physical inactivity .
OBJECTIVE	The aim of the study was to evaluate the effects of a respiratory physiotherapeutic program on liver transplantation candidates .
METHODS	Forty-two patients were evaluated by respiratory muscle strength , surface electromyography of the rectus abdominis and diaphragm , and spirometry .
METHODS	We also applied the SF-36 .
METHODS	The patients were divided into two groups : 12 randomly assigned to the control group and 5 in the intervention group .
METHODS	The intervention consisted of an explanatory and illustrative manual to be followed at home with diaphragmatic breathing exercises , diaphragmatic isometric exercise , Threshold IMT , lifting the upper limbs with a bat , and strengthening the abdominals .
RESULTS	Significant difference was found between initial forced expiratory flow ( FEF ) 25-75 % ( P = .042 ) and final FEF25-75 in the intervention group .
RESULTS	The control group had significant difference ( P = .036 ) in the diaphragm RMS between initial time and end time .
RESULTS	In conclusion , the control group showed greater electrical activity of the diaphragm after 3 months .
CONCLUSIONS	The intervention group benefited from the exercise , thus improving the FEF25-75 % .

###24275208
OBJECTIVE	To evaluate the effects of a tailored information package for rectal cancer patients on satisfaction with information , anxiety and depression and readjustment .
METHODS	The study used a randomised control trial method .
METHODS	Seventy six patients undergoing surgery and treatment for rectal cancer were randomly assigned to an intervention ( n = 43 ) or control group ( n = 33 ) .
METHODS	The intervention group received an information pack tailored according to their treatment plan and preferred information .
METHODS	The control group received the information currently given to these patients .
METHODS	Satisfaction with information was measured using the Patient Satisfaction with Cancer Treatment Education ( PSCaTE ) scale , anxiety and depression were measured using the Hospital Anxiety and Depression Scale ( HADS ) and readjustment was measured using the Reintegration to Normal Living Index , at three time points .
RESULTS	There was a statistically significant difference between the intervention and control group on pre and post intervention scores with patients in the intervention group expressing a higher level of satisfaction with information than those in the control group at Times 2 and 3 ( p = 0.00 for both ) .
RESULTS	The intervention group also had a significantly lower anxiety score than the control group at Time 3 ( p = 0.03 ) .
RESULTS	There was no difference between depression and readjustment scores in the two groups .
CONCLUSIONS	The results support the hypothesis that a tailored information pack for patients with rectal cancer will positively affect satisfaction with information .
CONCLUSIONS	These results will enhance the knowledge base surrounding the provision of tailored information to specific patient groups .

###24702815
OBJECTIVE	After subcutaneous injection insulin glargine is rapidly metabolized to M1 and M2 .
OBJECTIVE	In vitro , both M1 and M2 have metabolic effects and bind to IGF-1R similarly to human insulin , whereas glargine exhibits a higher affinity for the IGF-1R and greater mitogenetic effects .
OBJECTIVE	The present study was specifically designed to establish the dose-response metabolism of glargine over 24 h following s.c. injection in T2DM subjects on long-term use of glargine .
RESULTS	Ten subjects with T2DM were studied during 24 h after s.c. injection of 0.4 ( therapeutic ) and 0.8 ( high dose ) U/kg of glargine on two separate occasions during euglycaemic clamps ( cross-over design ) .
RESULTS	Glargine , M1 and M2 over 24 h period were determined in appropriately processed plasma samples by a specific liquid chromatography-tandem mass spectrometry assay .
RESULTS	Plasma M1 concentration ( AUC0-24 h ) was detected in all subjects and increased by increasing the glargine dose from therapeutic to high dose ( p = 0.008 ) .
RESULTS	Glargine was detectable in 6 ( therapeutic dose ) and 9 ( high dose ) out of the 10 subjects and also increased by increasing the dose ( p = 0.031 ) .
RESULTS	However , glargine concentration ( AUC0-24 h -- high dose ) represented at most only 9.7 % ( 4.6-15 % ) of the total amount of insulin measured in the blood .
RESULTS	M2 was not detected at all .
CONCLUSIONS	In T2DM people on long-term use of insulin glargine , even with higher doses ( 0.8 U/kg ) , glargine is nearly totally metabolized to the active metabolite M1 .
CONCLUSIONS	Glargine is often detectable in plasma , but its concentration remains well below that needed in vitro to potentiate IGF-1R binding and mitogenesis .

###24944864
BACKGROUND	The main aim of this pilot study was to investigate an advanced version of eye movement desensitization and reprocessing ( EMDR ) for reducing anxiety .
METHODS	Fifty participants were asked at two times of measurement ( T1 and T2 with a rest of 4 weeks ) to generate anxiety via the recall of autobiographical memories according to their anxiety .
METHODS	Furthermore , the participants were randomly assigned to an experimental group and a control group , and the experimental group received an intervention of 1-2 h with the advanced version of EMDR in order to their anxiety 2 weeks after T1 .
METHODS	At T1 as well as T2 , we measured the intensity of participants ' anxiety with a Likert scale ( LS ) and collected participants ' state ( temporary ) and trait ( chronic ) anxiety with the State-Trait Anxiety Inventory ( STAI ) .
METHODS	In addition , we measured participants ' physical performance in a test for the finger musculature under the induction of their anxiety .
RESULTS	The results showed that participant 's ratings of their perceived intensity of anxiety ( measured by a 9-point LS ) and the state and trait anxiety decreased significantly in the experimental group but not in the control group from T1 to T2 .
RESULTS	Moreover , the physical performance under the induction of participants ' anxiety increased significantly in the experimental group from T1 to T2 and there were no significant changes in the control group .
CONCLUSIONS	The study could show that the advanced version of EMDR is an appropriate method to reduce anxiety .

###24931702
OBJECTIVE	Identification of novel biomarkers of diabetes risk help to understand mechanisms of pathogenesis and improve risk prediction .
OBJECTIVE	Our objectives were to examine the relationships between adipokines , biomarkers of inflammation and endothelial function and development of type 2 diabetes ; and to assess the relevance of including these biomarkers in type 2 diabetes prediction risk models .
METHODS	1345 subjects from the SU.VI.MAX study , who were free of diabetes at baseline and who completed 13 years of follow-up were included in the present analyses .
METHODS	Odds ratios ( OR ) with 95 % confidence intervals ( 95 % CI ) of incident type 2 diabetes associated with a 1-SD increase in adiponectin , leptin , C-reactive protein ( CRP ) , soluble intracellular adhesion modecule-1 ( sICAM-1 ) , soluble vascular cell adhesion molecule 1 ( sVCAM-1 ) , E-selectin and monocyte chemoattractant protein-1 ( MCP-1 ) were estimated .
METHODS	Predicitive performances of models including biomarkers were assessed with area under the receiver operating curves ( AUC ) and integrated discrimination improvement ( IDI ) statistics .
RESULTS	82 subjects developed type 2 diabetes during follow-up .
RESULTS	The risk of developing type 2 diabetes increased with increasing concentrations of leptin ( 2.04 ( 1.28 ; 3.26 ) ) , sICAM-1 ( 1.39 ( 1.08 ; 1.78 ) ) and sVCAM-1 ( 1.29 ( 1.01 ; 1.64 ) ) .
RESULTS	Type 2 diabetes associations with leptin remained significant after adjusting for a combination of biomarkers .
RESULTS	Models adjusted for novel biomarkers had improved performance compared to models adjusted for classical risk factors as assessed by IDI , but not by AUC .
CONCLUSIONS	Adipokines , biomarkers of inflammation and endothelial function were significantly associated to onset of type 2 diabetes .
CONCLUSIONS	However their inclusion in predictive scores is not supported by the present study .

###24974806
OBJECTIVE	To our knowledge , no randomised study has compared rates of uncovered stent struts in everolimus ( EES ) vs. new-generation zotarolimus-eluting ( ZES-R ) stents in acute coronary syndrome ( ACS ) .
OBJECTIVE	The aim of our study was to evaluate the completeness of neointimal coverage with optical coherence tomography ( OCT ) in ACS patients treated with drug-eluting stents ( DES ) comparing EES versus new-generation ZES-R .
RESULTS	All eligible ACS patients admitted to four Italian centres with a clinical indication for culprit lesion intervention were randomised 1:1 to EES or ZES-R .
RESULTS	The primary study endpoint was the percentage of uncovered stent struts evaluated by optical coherence tomography ( OCT ) at six months .
RESULTS	Secondary endpoints were the percentage of malapposed stent struts , percent neointimal hyperplasia cross-sectional area ( CSA ) and major adverse cardiac events ( MACE ) at six months .
RESULTS	A total of 60 patients were randomised to EES ( n = 29 ) or ZES-R ( n = 31 ) .
RESULTS	No differences were observed in baseline characteristics between the two groups .
RESULTS	Overall , 31.7 % presented with STEMI , of which 68.4 % were anterior .
RESULTS	The other patients comprised 41.7 % NSTEMI and 26.7 % troponin-negative ACS .
RESULTS	A mean of 1.30.6 lesions were treated per patient , with a mean of 1.30.5 stents per lesion .
RESULTS	At 30 days there was one sudden death .
RESULTS	Six-month OCT analysis was performed in 25 lesions in the EES group and in 24 lesions in the ZES-R group .
RESULTS	There was no difference in the primary endpoint of uncovered stent struts between groups ( EES 6.42 % [ 3.27 , 9.57 ] vs. ZES-R 7.07 % [ 3.22 , 10.92 ] ; p = 0.80 ) .
RESULTS	Furthermore , there were no differences between groups in the percentage of malapposed stent struts , either with ( EES 1.19 % [ 0.34 , 2.04 ] vs. ZES-R 0.85 % [ 0.40 , 1.30 ] ; p = 0.49 ) or without coverage ( EES 1.06 % [ 0.12 , 2.01 ] vs. ZES-R 0.24 % [ 0.05 , 0.44 ] ; p = 0.09 ) .
RESULTS	Percent neointima CSA was similar in both groups ( EES 37.0 % [ 18.6 , 55.3 ] vs. ZES-R 26.6 % [ 18.4 , 34.8 ] ; p = 0.31 ) .
RESULTS	At six-month clinical follow-up , no additional patients died or suffered MI .
RESULTS	There were four MACE in the EES group and one in the ZES-R group .
CONCLUSIONS	In our study , in patients presenting with ACS , both EES and ZES-R had low percentages of malapposed and uncovered stent struts at six-month OCT analysis .

###24910215
OBJECTIVE	This prospective randomized pilot study reports our institutional experience and early results using Sonoma Wrx ( Sonoma Orthopedic Products , Santa Rosa , CA ) in the treatment of extra-articular and simple intra-articular distal radius fractures .
METHODS	A total of 64 patients , were enrolled in the study .
METHODS	They were considered eligible if they had ; unstable extra-articular distal radius fractures and simple intra-articular distal radius fractures suitable for closed reduction ( AO types ; A2 .2 , A2 .3 , A3 .1 C2 .1 , C2 .2 ) .
METHODS	Patients in group I received intramedullary fixation using the Sonoma Wrx device and patients in group II received standard volar locking plate fixation .
METHODS	Radiographic criteria of acceptable healing were used for evaluation .
RESULTS	Two groups were similar in terms of baseline characteristics .
RESULTS	Mean time of operation was significantly shorter in Group 1 vs. in group 2 ( 36.817.11 vs. 48.975.9 minutes , p = 0.001 ) .
RESULTS	Time to healing of the fracture was not different between two groups ( 5.451.09 vs. 5.701.04 weeks for Group 1 vs. 2 , respectively p = 0.36 ) .
RESULTS	Overall complications occurred in 9 patients in group 1 and in 15 patients in group 2 ( p = 0.17 ) .
RESULTS	Follow-up was completed in all patients with a median time of 12 months and 13 months in group 1 and 2 , respectively .
RESULTS	On radiographic evaluation radial inclination , radial height and volar tilt were not significantly different between group 1 and 2 , respectively .
RESULTS	There were no significant differences between two groups in regard to wrist rotational degrees measured in last follow-up visit .
CONCLUSIONS	Sonoma Wrx Device is reliable and effective in terms of achieving satisfactory outcomes in treatment of distal radius fractures .
CONCLUSIONS	It may be reasonable to use this device to prevent complications that are related to extensive soft tissue dissection .

###24500418
BACKGROUND	RAS is dysregulated in neurofibromatosis type 1 ( NF1 ) related plexiform neurofibromas ( PNs ) .
BACKGROUND	The activity of tipifarnib , which blocks RAS signaling by inhibiting its farnesylation , was tested in children and young adults with NF1 and progressive PNs .
METHODS	Patients aged 3-25 years with NF1-related PNs and imaging evidence of tumor progression were randomized in a double-blinded fashion to receive tipifarnib ( 200 mg/m ( 2 ) orally every 12 h ) or placebo ( phase A ) and crossed over to the opposite treatment arm at the time of tumor progression ( phase B ) .
METHODS	PN volumes were measured with MRI , and progression was defined as 20 % volume increase .
METHODS	Time to progression ( TTP ) in phase A was the primary endpoint , and the trial was powered to detect whether tipifarnib doubled TTP compared with placebo .
METHODS	Toxicity , response , and quality of life were also monitored .
RESULTS	Sixty-two patients were enrolled .
RESULTS	Tipifarnib and placebo were well tolerated .
RESULTS	On phase A , the median TTP was 10.6 months on the placebo arm and 19.2 months on the tipifarnib arm ( P = .12 ; 1-sided ) .
RESULTS	Quality of life improved significantly compared with baseline on the tipifarnib arm but not on the placebo arm .
RESULTS	Volumetric tumor measurement detected tumor progression earlier than conventional 2-dimensional ( WHO ) and 1-dimensional ( RECIST ) methods .
CONCLUSIONS	Tipifarnib was well tolerated but did not significantly prolong TTP of PNs compared with placebo .
CONCLUSIONS	The randomized , flexible crossover design and volumetric PN assessment provided a feasible and efficient means of assessing the efficacy of tipifarnib .
CONCLUSIONS	The placebo arm serves as an historical control group for phase 2 single-arm trials directed at progressive PNs .

###24835579
OBJECTIVE	To determine whether a midwife-led intervention improved preparation for twin parenting and maternal psychosocial outcome .
METHODS	Randomised controlled trial .
METHODS	Two maternity units in North East England .
METHODS	A cohort of 162 women with uncomplicated twin pregnancy .
METHODS	Self-completion questionnaire at multiple time points .
METHODS	The primary outcome was probable postnatal depression ( measured with the Edinburgh Postnatal Depression Scale , EPDS ) 26 weeks after delivery .
METHODS	Secondary outcomes included preparation for parenting , maternal anxiety , parenting stress , and maternal wellbeing .
RESULTS	The mean maternal EPDS scores at 26 weeks after delivery were 5.4 ( SD 4.5 ) in the twin intervention ( TI ) group and 6.9 ( SD 5.5 ) in the twin control ( TC ) group , and the mean difference between the groups was 1.5 ( 95 % confidence interval , 95 % CI , -0.2 to 3.3 ) .
RESULTS	The relative risk ( RR ) of having probable depression in the TI group compared with the TC group at 26 weeks was 0.48 ( 95 % CI 0.19-1 .20 ) for mothers and 0.84 ( 95 % CI 0.42-1 .70 ) for fathers .
RESULTS	There were no statistically significant differences in maternal anxiety or parenting stress .
RESULTS	TI mothers reported increased maternal wellbeing , reaction to motherhood , family support , mood , and greater self-confidence 26 weeks after delivery , and felt more prepared for parenting .
CONCLUSIONS	As a result of the limited sample size , the study was unable to detect a difference in maternal depression using the maternal EPDS mean score .
CONCLUSIONS	The antenatal preparation for parenting programme did not improve postnatal maternal anxiety or parenting stress ; however , it did improve postnatal maternal wellbeing , mood , self-confidence , reaction to motherhood , and better prepared mothers to parent twin infants .
CONCLUSIONS	Midwives have a key role in preparing mothers to parent twins .

###24565955
BACKGROUND	Prior studies suggest that elevated markers of bone turnover are prognostic for poor survival in castration-resistant prostate cancer ( CRPC ) .
BACKGROUND	The predictive role of these markers relative to bone-targeted therapy is unknown .
BACKGROUND	We prospectively evaluated the prognostic and predictive value of bone biomarkers in sera from CRPC patients treated on a placebo-controlled phase III trial of docetaxel with or without the bone targeted endothelin-A receptor antagonist atrasentan ( SWOG S0421 ) .
METHODS	Markers for bone resorption ( N-telopeptide and pyridinoline ) and formation ( C-terminal collagen propeptide and bone alkaline phosphatase ) were assayed in pretreatment and serial sera .
METHODS	Cox proportional hazards regression models were fit for overall survival .
METHODS	Models were fit with main effects for marker levels and with/without terms for marker-treatment interaction , adjusted for clinical variables , to assess the prognostic and predictive value of atrasentan .
METHODS	Analysis was adjusted for multiple comparisons .
METHODS	Two-sided P values were calculated using the Wald test .
RESULTS	Sera from 778 patients were analyzed .
RESULTS	Elevated baseline levels of each of the markers were associated with worse survival ( P < .001 ) .
RESULTS	Increasing marker levels by week nine of therapy were also associated with subsequent poor survival ( P < .001 ) .
RESULTS	Patients with the highest marker levels ( upper 25th percentile for all markers ) not only had a poor prognosis ( hazard ratio [ HR ] = 4.3 ; 95 % confidence interval [ CI ] = 2.41 to 7.65 ; P < .001 ) but also had a survival benefit from atrasentan ( HR = 0.33 ; 95 % CI = 0.15 to 0.71 ; median survival = 13 [ atrasentan ] vs 5 months [ placebo ] ; P interaction = .005 ) .
CONCLUSIONS	Serum bone metabolism markers have statistically significant independent prognostic value in CRPC .
CONCLUSIONS	Importantly , a small group of patients ( 6 % ) with highly elevated markers of bone turnover appear to preferentially benefit from atrasentan therapy .

###24562802
OBJECTIVE	Limited data exist concerning outcomes of patients with non-ST-segment elevation acute coronary syndromes ( NSTE ACS ) with no angiographically obstructive coronary artery disease ( non-obstructive CAD ) .
OBJECTIVE	We assessed the frequency of clinical outcomes among patients with non-obstructive CAD compared with obstructive CAD .
RESULTS	We pooled data from eight NSTE ACS randomized clinical trials from 1994 to 2008 , including 37,101 patients who underwent coronary angiography .
RESULTS	The primary outcome was 30-day death or myocardial infarction ( MI ) .
RESULTS	Adjusted odds ratios ( ORs ) and 95 % confidence intervals ( CIs ) for 30-day death or MI for non-obstructive versus obstructive CAD were generated for each trial .
RESULTS	Summary ORs ( 95 % CIs ) across trials were generated using random effects models .
RESULTS	Overall , 3550 patients ( 9.6 % ) had non-obstructive CAD .
RESULTS	They were younger , more were female , and fewer had diabetes mellitus , previous MI or prior percutaneous coronary intervention than patients with obstructive CAD .
RESULTS	Thirty-day death or MI was less frequent among patients with non-obstructive CAD ( 2.2 % ) versus obstructive CAD ( 13.3 % ) ( OR ( adj ) 0.15 ; 95 % CI , 0.11-0 .20 ) ; 30-day death or spontaneous MI and six-month mortality were also less frequent among patients with non-obstructive CAD ( OR ( adj ) 0.19 ( 0.14-0 .25 ) and 0.37 ( 0.28-0 .49 ) , respectively ) .
CONCLUSIONS	Among patients with NSTE ACS , one in 10 had non-obstructive CAD .
CONCLUSIONS	Death or MI occurred in 2.2 % of these patients by 30 days .
CONCLUSIONS	Compared with patients with obstructive CAD , the rate of major cardiac events was lower in patients with non-obstructive CAD but was not negligible , prompting the need to better understand management strategies for this group .

###25877963
BACKGROUND	The week 48 primary analysis of the ENCORE1 trial established the virological non-inferiority and safety of efavirenz 400 mg compared with the standard 600 mg dose , combined with tenofovir and emtricitabine , as first-line HIV therapy .
BACKGROUND	This 96-week follow-up of the trial assesses the durability of efficacy and safety of this treatment over 96 weeks .
METHODS	ENCORE1 was a double-blind , placebo-controlled , non-inferiority trial done at 38 clinical sites in 13 countries .
METHODS	HIV-infected adult patients ( 16 years of age ) with no previous antiretroviral therapy , a CD4 cell count of 50-500 cells per L , and plasma HIV-1 viral load of at least 1000 copies per mL were randomly assigned ( 1:1 ) by an electronic case report form to receive fixed-dose daily tenofovir 300 mg and emtricitabine 200 mg plus efavirenz either 400 mg daily or 600 mg daily .
METHODS	Participants , physicians , and all other trial staff were masked to treatment assignment .
METHODS	Randomisation was stratified by HIV-1 viral load at baseline ( or > 100000 copies per mL ) .
METHODS	The primary endpoint was the difference in the proportions of patients in the two treatment groups with a plasma HIV-1 viral load below 200 copies per mL at week 96 .
METHODS	Treatment groups were deemed to be non-inferior if the lower limit of the 95 % CI for the difference in viral load was above -10 % by modified intention-to-treat analysis .
METHODS	Non-inferiority was assessed in the modified intention-to-treat , per-protocol , and non-completer = failure ( NC = F ) populations .
METHODS	Adverse events and serious adverse events were summarised by treatment group .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01011413 .
RESULTS	Between Aug 24 , 2011 , and March 19 , 2012 , 636 eligible participants were enrolled and randomly assigned to the two treatment groups ( 324 to efavirenz 400 mg and 312 to efavirenz 600 mg ) .
RESULTS	The intention-to-treat population who received at least one dose of study drug comprised 630 patients : 321 in the efavirenz 400 mg group and 309 in the efavirenz 600 mg group .
RESULTS	585 patients ( 93 % ; 299 in the efavirenz 400 mg group and 286 in the 600 mg group ) completed 96 weeks of follow-up .
RESULTS	At 96 weeks , 289 ( 900 % ) of 321 patients in the efavirenz 400 mg group and 280 ( 906 % ) of 309 in the efavirenz 600 mg group had a plasma HIV-1 viral load less than 200 copies per mL ( difference -06 , 95 % CI -52 to 40 ; p = 072 ) , which suggests continued non-inferiority of the lower efavirenz dose .
RESULTS	Non-inferiority was recorded for thresholds of less than 50 and less than 400 copies per mL , irrespective of baseline plasma viral load .
RESULTS	Adverse events were reported by 291 ( 91 % ) of 321 patients in the efavirenz 400 mg group and by 285 ( 92 % ) of 309 in the 600 mg group ( p = 048 ) .
RESULTS	The proportions of patients reporting an adverse event that was definitely or probably related to efavirenz were 126 ( 39 % ) for efavirenz 400 mg and 148 ( 48 % ) for efavirenz 600 mg ( p = 003 ) .
RESULTS	The number of patients who reported serious adverse events did not differ between the groups ( p = 020 ) .
CONCLUSIONS	Our findings confirm that efavirenz 400 mg is non-inferior to the standard dose of 600 mg in combination with tenofovir and emtricitabine as initial HIV therapy over 96 weeks .
CONCLUSIONS	Fewer efavirenz-related adverse events were reported with the 400 mg efavirenz dose than with the 600 mg dose .
CONCLUSIONS	These findings support the routine use of efavirenz 400 mg .
CONCLUSIONS	The coadministration of rifampicin and efavirenz 400 mg needs further investigation .
BACKGROUND	Bill & Melinda Gates Foundation , and UNSW Australia .

###24804697
OBJECTIVE	Overnight hypoglycemia occurs frequently in individuals with type 1 diabetes and can result in loss of consciousness , seizure , or even death .
OBJECTIVE	We conducted an in-home randomized trial to determine whether nocturnal hypoglycemia could be safely reduced by temporarily suspending pump insulin delivery when hypoglycemia was predicted by an algorithm based on continuous glucose monitoring ( CGM ) glucose levels .
METHODS	Following an initial run-in phase , a 42-night trial was conducted in 45 individuals aged 15-45 years with type 1 diabetes in which each night was assigned randomly to either having the predictive low-glucose suspend system active ( intervention night ) or inactive ( control night ) .
METHODS	The primary outcome was the proportion of nights in which 1 CGM glucose values 60 mg/dL occurred .
RESULTS	Overnight hypoglycemia with at least one CGM value 60 mg/dL occurred on 196 of 942 ( 21 % ) intervention nights versus 322 of 970 ( 33 % ) control nights ( odds ratio 0.52 [ 95 % CI 0.43-0 .64 ] ; P < 0.001 ) .
RESULTS	Median hypoglycemia area under the curve was reduced by 81 % , and hypoglycemia lasting > 2 h was reduced by 74 % .
RESULTS	Overnight sensor glucose was > 180 mg/dL during 57 % of control nights and 59 % of intervention nights ( P = 0.17 ) , while morning blood glucose was > 180 mg/dL following 21 % and 27 % of nights , respectively ( P < 0.001 ) , and > 250 mg/dL following 6 % and 6 % , respectively .
RESULTS	Morning ketosis was present < 1 % of the time in each arm .
CONCLUSIONS	Use of a nocturnal low-glucose suspend system can substantially reduce overnight hypoglycemia without an increase in morning ketosis .

###24885949
BACKGROUND	Male clients of female sex workers ( FSWs ) are at risk of HIV and other sexually transmitted infections ( STIs ) .
BACKGROUND	We conducted a two-arm randomized controlled trial to test the efficacy of a sexual risk reduction intervention for male clients of FSWs in Tijuana , Mexico .
METHODS	Male clients of FSWs who were at least 18 , were HIV-negative at baseline , and reported recent unprotected sex with FSWs were randomized to the Hombre Seguro sexual risk reduction intervention , or a time-attention didactic control condition .
METHODS	Each condition lasted approximately one hour .
METHODS	Participants underwent interviewer-administered surveys and testing for HIV and other STIs at baseline , and at 4 , 8 , and 12month follow-ups .
METHODS	Combined HIV/STI incidence and unprotected vaginal and anal sex acts with FSWs were the primary outcomes .
CONCLUSIONS	A total of 400 participants were randomized to one of the two conditions .
CONCLUSIONS	Analyses indicated that randomization was successful ; there were no significant differences between the participants in the two conditions at baseline .
CONCLUSIONS	Average follow-up was 84 % across both conditions .
CONCLUSIONS	This is the first study to test the efficacy of a sexual risk reduction intervention for male clients of FSWs using the rigor of a randomized controlled trial .
BACKGROUND	NCT01280838 , Date of registration : January 19 , 2011 .

###25628269
OBJECTIVE	To determine the clinical performance of DAILIES TOTAL1 ( DT1 ) , Clariti 1Day ( C1D ) , and 1-DAY ACUVUE TruEye ( AVTE ) silicone hydrogel daily disposable contact lenses ( SiHy DDCLs ) .
METHODS	Eligible participants , subdivided into asymptomatic and symptomatic groups , wore each SiHy DDCLs for three consecutive days .
METHODS	Each participant attended three visits ( on day 1 at 0 hours ; on days 1 and 3 after 8 hours of wear ) per lens type .
METHODS	The order of lens wear was randomized , with at least 1 day washout between lenses .
METHODS	Lens-related performance was evaluated by assessing lens surface deposits , wettability , pre-lens noninvasive tear breakup time , lens movement , and centration ; ocular response assessments included conjunctival redness , corneal staining , and conjunctival staining and indentation .
RESULTS	Fifty-one asymptomatic and 53 symptomatic participants completed the study .
RESULTS	For all visits , the mean noninvasive tear breakup time was about 1 second longer with DT1 than with C1D and AVTE ( p < 0.01 ) .
RESULTS	Overall , the wettability of all three lenses was good ; however , DT1 was graded marginally better than the other lenses ( both p < 0.01 ) .
RESULTS	On day 3 , eyes wearing AVTE had significantly more dehydration-induced corneal staining compared with DT1 ( AVTE , 24 % ; DT1 , 11 % ; p < 0.01 ) .
RESULTS	After 8 hours , conjunctival staining was different between lenses ( greatest with C1D and least with DT1 ; all p < 0.01 ) .
RESULTS	Conjunctival indentation was more prevalent with the C1D lenses ( n = 70 ) compared with DT1 ( n = 1 ; p < 0.01 ) and AVTE ( n = 11 ; p < 0.01 ) .
RESULTS	There were no differences between asymptomatic and symptomatic lens wearers for any of the clinical parameters ( all p > 0.05 ) .
CONCLUSIONS	Each of the three SiHy DDCLs performed well .
CONCLUSIONS	Noninvasive tear breakup time was longest and wettability was greater with DT1 .
CONCLUSIONS	C1D had the most conjunctival staining conjunctival indentation .
CONCLUSIONS	There was no difference between asymptomatic and symptomatic wearers with regard to ocular response and contact lens-related parameters .
CONCLUSIONS	These results suggest that SiHy DDCLs may be an excellent contact lens modality for the symptomatic patient .

###26114347
BACKGROUND	Hydrocarbons , especially kerosene ( paraffin ) , are the most common agents causing childhood poisoning in low and middle income countries ( LMICs ) .
BACKGROUND	Aspiration of kerosene causes an inflammatory sterile chemical pneumonitis , which may increase susceptibility to secondary lower respiratory tract bacterial infection .
BACKGROUND	This study aimed to assess the efficacy of prophylactic antibiotics in the management of kerosene-associated pneumonitis in children and to identify risk factors associated with severity or outcome .
METHODS	A double-blind placebo-controlled trial of prophylactic antibiotics in the management of kerosene-associated pneumonitis of children presenting to a referral hospital was performed from July 2010 to September 2011 .
METHODS	Sequential children with a history of kerosene ingestion and mild respiratory illness were randomised to receive placebo or amoxicillin .
METHODS	Each child was followed-up at Day 3 and Day 5 post-ingestion .
METHODS	The primary outcome measure was the number of treatment failures in each group , defined as any child who deteriorated within this time , necessitating a change in treatment regimen .
METHODS	Secondary outcome measures were length of hospital stay and symptoms and signs at follow-up .
RESULTS	Seventy-four patients were enrolled .
RESULTS	Thirty-five ( 47 % ) received placebo and 39 ( 53 % ) active treatment .
RESULTS	There was no significant difference in treatment failures between placebo ( 3/35 , 9 % ; 95 % CI , 3-22 ) and active ( 2/39 , 5 % ; 95 % CI , 1-17 ) groups ( relative risk , 0.60 ; 95 % CI , 0.11-3 .37 ) .
RESULTS	The median length of hospital stay was identical ( placebo 0.5 days ; IQR , 0-1 .0 and active 0.5 days ; IQR , 0.5-1 .0 ) .
RESULTS	Symptoms and signs at Days 3 and 5 post-ingestion were similar .
RESULTS	The only significant risk factor for treatment failure was residence in formal housing .
RESULTS	Clinical severity at presentation was similar for treatment successes and failures .
CONCLUSIONS	Prophylactic antibiotics do not improve the outcome in children with mild respiratory illness after kerosene ingestion .

###25895304
OBJECTIVE	To discuss the role of carbon nanoparticles in the protection of parathyroid during thyroid carcinoma surgery .
METHODS	Seventy-two patients with thyroid carcinoma who had initial surgery were randomly divided into two groups : carbon nanoparticles group and the control group .
METHODS	Emulsion of carbon nanoparticles was injected into the thyroid gland of carbon nanoparticles group patients .
METHODS	After thirty minutes , the excision of thyroid carcinoma and VI group neck dissection were performed in carbon nanoparticles group patients , the control group directly underwent operation .
METHODS	The black stained tissue in the dissection specimen of carbon nanoparticles group was separated .
METHODS	The number of total lymph node , metastasis lymph node and parathyroid gland in the tissure black stained or not in two groups were counted respectively .
RESULTS	There were 312 lymph nodes in the black stained tissue of central compartment dissection specimen of carbon nanoparticles group .
RESULTS	No parathyroid gland was found in the black stained tissue .
RESULTS	Fifteen lymph nodes containing four parathyroid glands were found in the non black stained tissue in carbon nanoparticles group while there were 202 lymph nodes containing 13 parathyroid glands in the control group .
RESULTS	There were statistical difference between the amount of lymph node in black stain tissue and the specimen of the control group .
RESULTS	Parathyroid glands were not stained black , and no parathyroid gland was found in the black-stained tissue .
CONCLUSIONS	The carbon nanoparticles could be used to identify the lymph node and the parathyroid gland for protecting the parathyroid gland in thyroid surgery .

###24685847
BACKGROUND	Chronic urticaria not responsive to antihistamines is a difficult disease to manage .
BACKGROUND	Methotrexate has been used in difficult chronic urticarias with some benefit .
OBJECTIVE	To evaluate the efficacy of methotrexate in the treatment of chronic spontaneous urticaria poorly responsive to H1 antihistaminics .
METHODS	In a randomized double-blind trial at the Department of Dermatology and Venereology of a tertiary care centre , 29 patients with chronic spontaneous urticaria not responding well to H1 antihistaminics were recruited .
METHODS	Patients were randomly allocated to receive either a weekly dose of oral methotrexate 15 mg or placebo ( calcium carbonate ) for a total duration of 12 weeks , after which treatment was stopped and patients were followed up for relapse of urticaria .
METHODS	Each group also received levocetrizine 5 mg once daily for symptom control .
METHODS	Primary outcome measured was a reduction by > 2/3 rd of baseline urticaria scores after 12 week therapy .
METHODS	Secondary outcome was a reduction in antihistamine requirement after stopping therapy .
RESULTS	Fourteen patients were randomized to the methotrexate group and fifteen patients to the placebo group .
RESULTS	Out of 17 patients who completed therapy , the primary outcome was achieved by 3.5 1.9 ( out of 10 ) patients in the methotrexate group and by 3.67 1.03 ( out of 7 ) patients in the placebo group ( P > 0.05 ) .
RESULTS	Ten patients followed up , after stopping therapy , for a mean period of 3.5 2.4 months ; 3 remained in remission and 7 had relapsed .
RESULTS	One patient had uncontrollable nausea and vomiting after taking methotrexate and was withdrawn from the study .
RESULTS	The placebo group did not experience any side effects .
CONCLUSIONS	Methotrexate 15 mg weekly for 3 months did not provide any additional benefit over H1 antihistamines in this study but an adequately powered study with longer follow up is required to assess its utility .

###24496783
BACKGROUND	Postoperative continuous positive airway pressure ( CPAP ) can improve lung function .
BACKGROUND	The aim of our study was to assess the efficacy of prophylactic CPAP on the Pa ( O2 ) / FI ( O2 ) ratio measured the day after surgery in patients undergoing lung resection surgery ( LRS ) .
METHODS	The study population comprised 110 patients undergoing LRS .
METHODS	On arrival in the postanaesthesia care unit ( PACU ) , patients were randomized to receive CPAP at 5-7 cm H2O during the first 6 h after surgery ( CPAP group ) or supplemental oxygen through a Venturi mask ( Venturi group ) .
METHODS	The Pa ( O2 ) / FI ( O2 ) ratio was measured on arrival in the PACU , 7 h after admission , and the day after surgery .
METHODS	The Pa ( O2 ) / FI ( O2 ) ratio is the primary endpoint of our study .
METHODS	We also analysed the chest radiograph and assessed the postoperative course .
METHODS	We then analysed the impact of ventilatory management in the PACU depending on the respiratory risk of the patient .
RESULTS	Baseline characteristics were similar in both groups .
RESULTS	Patients who received CPAP had significantly higher Pa ( O2 ) / FI ( O2 ) at 24 h after surgery compared with patients managed conventionally ( Venturi group ) ( 48.614 vs 42.312 , P = 0.031 ) , but there were no differences at 7 h. On subgroup analysis , we found that the benefits of CPAP were greater in higher risk patients .
RESULTS	The incidence of postoperative pulmonary complications and stay in the PACU and hospital were similar in both groups .
CONCLUSIONS	In patients undergoing LRS , prophylactic CPAP during the first 6 h after surgery with a pressure of 5-7 cm H2O improved the Pa ( O2 ) / FI ( O2 ) ratio at 24 h.
CONCLUSIONS	This effect was more evident in patients with increased risk of postoperative pulmonary complications .

###25343235
BACKGROUND	Maternal obesity and gestational weight gain are linked to offspring adverse metabolic profiles , and lifestyle interventions during pregnancy in obese women may have long-term positive effects on their children .
BACKGROUND	Furthermore , although the association between birth weight and later metabolic outcomes is well established , little is known about the predictive value of abdominal circumference at birth .
OBJECTIVE	The purpose of this study was to determine ( 1 ) the effects of lifestyle interventions during pregnancy in obese women on offspring metabolic risk factors and ( 2 ) predictive values of birth weight ( BW ) and birth abdominal circumference ( BAC ) .
METHODS	This was a follow-up of a randomized controlled trial , the Lifestyle in Pregnancy ( LiP ) study .
METHODS	The study was conducted in Odense and Aarhus University Hospitals , Denmark .
METHODS	We studied the offspring of LiP study participants ( n = 157 ) and offspring of normal-weight mothers ( external reference group , n = 97 ) .
METHODS	INTERVENTIONs included dietary advice , coaching , and exercise during pregnancy .
METHODS	The outcome measures were body mass index ( BMI ) Z-score , abdominal circumference , blood pressure , and fasting plasma glucose , insulin , high-density lipoprotein , and triglycerides at the age of 2.8 years .
RESULTS	No differences were detected in BMI Z-scores or metabolic risk factors between the LiP intervention and control groups or between the LiP and external reference groups .
RESULTS	BAC and BW were associated ( all P < .05 ) with BMI Z-score ( 0.19-0 .23 ) , abdominal circumference ( 0.57-0 .70 ) , plasma glucose ( 0.11-0 .09 ) , insulin ( 4.33-3 .13 ) , and triglycerides ( 0.07-0 .07 ) but not with blood pressure or high-density lipoprotein ( regression coefficients per increase in BAC and BW of 1 SD score ) .
CONCLUSIONS	Early childhood metabolic risk factors were unaffected by lifestyle interventions in obese pregnant women .
CONCLUSIONS	Offspring of obese mothers who participated in the LiP study were comparable to offspring of normal-weight mothers , possibly indicating a general beneficial effect of trial participation .
CONCLUSIONS	BAC and BW were both associated with later metabolic risk factors .

###24220914
BACKGROUND	Colorectal cancer screening ( CRCS ) reduces morbidity and mortality ; however , the positive benefits might be partially offset by long-term distress following positive screening results .
BACKGROUND	We examined relationships among colorectal cancer-specific worry and situational anxiety after positive fecal occult blood tests [ FOBT ( + ) ] compared with receipt of negative results .
METHODS	Of note , 2,260 eligible members of Group Health , an integrated healthcare delivery system , completed baseline surveys and received FOBT screening kits , with 1,467 members returning the kits .
METHODS	We matched FOBT ( + ) patients ( n = 55 ) 1:2 on age and sex with FOBT ( - ) respondents ( n = 110 ) .
METHODS	Both groups completed follow-up surveys at 7 to 14 days and 4 months after screening .
METHODS	We assessed situational anxiety ( State-Trait Anxiety Inventory , STAI ) , colorectal cancer worry frequency , and mood disturbance .
RESULTS	Mean age was 59 years , and majority were women ( 62 % ) and White ( 89 % ) .
RESULTS	After adjusting for age , sex , and baseline worry , at 7 to 14 days after screening , the FOBT ( + ) group was 3.82 [ 95 % confidence interval ( CI ) , 1.09-13 .43 ] times more likely to report colorectal cancer-related mood disturbances and significantly higher mean STAI scores than the FOBT ( - ) group ( mean = 38.8 vs. 30.9 ; P = 0.007 ) .
RESULTS	At 4-month posttest , mood disturbances and situational anxiety seemed to drop to baseline levels for FOBT ( + ) .
RESULTS	No colon cancer worry frequency was observed .
CONCLUSIONS	FOBT ( + ) results are associated with short-term situational anxiety and colorectal cancer-specific mood disturbances .
CONCLUSIONS	Distress from FOBT ( + ) results declined to near-baseline levels by 4 months .
CONCLUSIONS	Additional studies are needed to clarify the relationship between long-term distress and follow-up colonoscopy .

###25350595
OBJECTIVE	The purpose of this study was to assess the anti-inflammatory , analgesic and osteogenic early effects of melatonin on post-extraction sockets of patients requiring third molars extraction .
METHODS	A randomized , triple-blind clinical trial was made using a split-mouth design .
METHODS	Both lower third molars of 10 patients were extracted and 3 mg of local melatonin or placebo were applied .
METHODS	Concentrations of interleukin-6 and nitrotyrosine were determined on samples of the clot from the socket by independent ELISA tests .
METHODS	Radiographic bone density was evaluated by measuring Hounsfield Units in panoramic and cross sections obtained by digital scanner .
METHODS	Statistical analysis by Kolmogorov-Smirnov test was performed for ELISA data .
METHODS	Bone density was analyzed by Shapiro-Wilk test .
METHODS	Subsequently t test was applied .
METHODS	P < 0.05 was considered to be significant .
RESULTS	The concentration of interleukin-6 increased with the application of melatonin without statistically significance ( 361.32 235.22 pg/ml vs 262.58 233.92 pg/ml ) .
RESULTS	Nitrotyrosine concentrations showed values below to the detectability pattern ( < 0.001 nM ) in Optic Density curve .
RESULTS	Bone density in panoramic sections at socket after melatonin application showed no significant difference ( 561.98 105.92 HU vs 598.82 209.03 HU ) .
RESULTS	In cross sections , bone density in the alveolar region showed no significant difference ( 377.42 125.67 HU vs 347.56 97.02 HU ) .
CONCLUSIONS	Within the limitations of this pilot study , no differences with the application of melatonin were found in terms of the concentration of interleukin-6 and bone density in post-extraction socket of retained mandibular third molars .

###25346506
BACKGROUND	There is consistent evidence that the binge drinking standard of 5 + drinks per drinking occasion for men ( 4 + for women ) is associated with risk for negative consequences .
BACKGROUND	Yet , many have questioned the adequacy of this measure as an index of intoxication ( e.g. , a blood alcohol concentration [ BAC ] of 0.08 g % ) .
BACKGROUND	In response to these concerns , a National Institute on Alcohol Abuse and Alcoholism task force recommended adding a time qualifier of 2hours to this criterion .
BACKGROUND	Although conceptually appealing , there has been little effort to determine whether this new measure better captures drinking that leads to negative consequences .
METHODS	This study examined the new binge standard ( 2-hour period ) and old binge standard ( no time qualifier ) in relation to frequency of drinking to an estimated BAC of 0.08 g % and the experience of negative drinking consequences .
METHODS	These relations were examined within both a social drinking sample of adults ( N = 200 ) and a sample of heavy-drinking young adults ( N = 168 ) participating in a randomized clinical trial for drinking reduction .
RESULTS	Contrary to the purpose of adding a time qualifier , the new binge measure was not more strongly correlated with drinking to an estimated BAC of 0.08 g % relative to the old binge measure .
RESULTS	In addition , when both measures were entered simultaneously into a regression model , only the old binge measure accounted for significant variance in negative drinking consequences .
CONCLUSIONS	These empirically based results suggest that the original binge standard without a time qualifier may be preferable to the 2-hour standard as a marker for risk .
CONCLUSIONS	The findings also suggest that further efforts are needed to identify a brief measure that effectively captures drinking to intoxication and related risk for negative consequences .

###25238062
BACKGROUND	Green tea ( GT ) is able to increase energy expenditure ( EE ) and fat oxidation ( FATox ) via inhibition of catechol-O-methyl transferase ( COMT ) by catechins .
BACKGROUND	However , this does not always appear unanimously because of large inter-individual variability .
BACKGROUND	This may be explained by different alleles of the functional COMT Val108/158Met polymorphism that are associated with COMT enzyme activity ; high-activity enzyme , COMT ( H ) ( Val/Val genotype ) , and low-activity COMT ( L ) ( Met/Met genotype ) .
METHODS	Fourteen Caucasian subjects ( BMI : 22.22.3 kg/m2 , age : 21.42.2 years ) of whom 7 with the COMT ( H ) - genotype and 7 with the COMT ( L ) - genotype were included in a randomized , cross-over study in which EE and substrate oxidation were measured with a ventilated-hood system after decaffeinated GT and placebo ( PL ) consumption .
RESULTS	At baseline , EE , RQ , FATox and carbohydrate oxidation ( CHOox ) did not differ between groups .
RESULTS	Significant interactions were observed between COMT genotypes and treatment for RQ , FATox and CHOox ( p < 0.05 ) .
RESULTS	After GT vs. PL , EE ( GT : 62.2 vs. PL : 35.4 kJ .3.5 hrs ; p < 0.01 ) , RQ ( GT : 0.80 vs. PL : 0.83 ; p < 0.01 ) , FATox ( GT : 18.3 vs. PL : 15.3 g/d ; p < 0.001 ) and CHOox ( GT : 18.5 vs. PL : 24.3 g/d ; p < 0.001 ) were significantly different for subjects carrying the COMT ( H ) genotype , but not for subjects carrying the COMT ( L ) genotype ( EE , GT : 60.3 vs. PL : 51.7 kJ .3.5 hrs ; NS ) , ( RQ , GT : 0.81 vs. PL : 0.81 ; NS ) , ( FATox , GT : 17.3 vs. PL : 17.0 g/d ; NS ) , ( CHOox , GT : 22.1 vs. PL : 21.4 g/d ; NS ) .
CONCLUSIONS	Subjects carrying the COMT ( H ) genotype increased energy expenditure and fat-oxidation upon ingestion of green tea catechins vs , placebo , whereas COMT ( L ) genotype carriers reacted similarly to GT and PL ingestion .
CONCLUSIONS	The differences in responses were due to the different responses on PL ingestion , but similar responses to GT ingestion , pointing to different mechanisms .
CONCLUSIONS	The different alleles of the functional COMT Val108/158Met polymorphism appear to play a role in the inter-individual variability for EE and FATox after GT treatment .
BACKGROUND	Nederlands Trial register NTR1918 .

###25247897
BACKGROUND	Caudal analgesia has been prolonged by the addition of various adjuvants .
BACKGROUND	Dexmedetomidine is a highly selective alpha-2 agonist with sedative and analgesic properties .
OBJECTIVE	To investigate the effect of addition of dexmedetomidine to 0.25 % bupivacaine for caudal analgesia in children undergoing major abdominal cancer surgery .
METHODS	A randomized double-blind trial .
METHODS	Academic medical center .
METHODS	Forty pediatric patients , aged 3 - 12 years , weighting 10 - 40 kg , and of American Society of Anesthesiologists ( ASA ) physical status I and II scheduled for major abdominal cancer surgeries under general anesthesia combined with caudal analgesia were enrolled .
METHODS	They were randomly allocated into 2 groups : Group I ( BD ) : ( n = 20 ) received 1 mL/kg bupivacaine 0.25 % with dexmedetomidine 1 g/kg and group II ( B ) : ( n = 20 ) received 1 mL/kg bupivacaine 0.25 % .
METHODS	Heart rate ( HR ) , mean arterial pressure ( MAP ) , and oxygen saturation ( SPO2 ) were recorded for 120 minutes .
METHODS	Pain was assessed immediately postoperative and at hours 2 , 4 , 6 , 12 , 18 , and 24 of postoperative period by Face , Legs , Activity , Cry and Consolability ( FLACC ) score .
METHODS	Time to first request for analgesia and total analgesic consumption in the first 24 hours were recorded .
METHODS	The level of sedation was recorded using Ramsay 's sedation scale [ Intravenous acetaminophen 15mg/kg ( perfalgan , Squibb ) ] .
METHODS	Adverse effects were recorded and treated .
RESULTS	There was significant reduction in FLACC score in group BD at 2 , 4 , 6 , and 12 hours postoperatively compared to group B.
RESULTS	At the eighteenth and twenty-fourth hour there was no significant difference .
RESULTS	Time of the first rescue analgesic requirement was significantly prolonged in group BD compared to group B.
RESULTS	The mean total consumption of rescue analgesia in the 24 hours of the postoperative period was significantly decreased in group BD ( 405.00 215.03 ) mg when compared with group B ( 810.35 200.93 ) mg .
CONCLUSIONS	This study is limited by its small sample size .
CONCLUSIONS	Addition of dexmedetomidine ( 1 g/kg ) to caudal bupivacaine 0.25 % ( 1 mL/kg ) in pediatric major abdominal cancer surgeries achieved significant postoperative pain relief for up to 19 hours , with less use of postoperative analgesics , and prolonged duration of arousable sedation .
CONCLUSIONS	Hemodynamic changes were statistically significant , yet of no clinical significance .

###24636382
OBJECTIVE	To develop a mapping algorithm for estimating EuroQol five-dimensional ( EQ-5D ) questionnaire values from the prostate cancer-specific health-related quality-of-life ( HRQOL ) instrument Functional Assessment of Cancer Therapy-Prostate ( FACT-P ) instrument .
METHODS	The EQ-5D questionnaire and FACT-P instrument data were collected for a subset of patients with metastatic castration-resistant prostate cancer in a multicenter , randomized , double-blind , placebo-controlled phase 3 trial .
METHODS	We compared three statistical techniques to estimate patients ' EQ-5D questionnaire index scores determined by using the UK tariff : 1 ) generalized estimating equations , 2 ) two-part model combining logistic regression and generalized estimating equation , and 3 ) separate mapping algorithms for patients with poor health defined as a FACT-P score of 76 or less ( group-specific model ) .
METHODS	Four different sets of explanatory variables were compared .
METHODS	The models were cross-validated by using a 10-fold in-sample cross-validation .
RESULTS	Values for both instruments were available for 236 patients with metastatic castration-resistant prostate cancer .
RESULTS	The group-specific model including the FACT-P subscale scores and baseline variables had the best predictive performance with R ( 2 ) 0.718 , root mean square error 0.162 , and mean absolute error 0.117 .
RESULTS	The two-part model and the generalized estimating equation model including the FACT-P subdomain scores and baseline variables also had good predictive performance .
CONCLUSIONS	The developed algorithms for mapping the FACT-P instrument to the EQ-5D questionnaire enable the estimation of preference-based health-related quality-of-life scores for use in cost-effectiveness analyses when directly elicited EQ-5D questionnaire data are missing .

###24667866
OBJECTIVE	Very-low-birth-weight ( VLBW ) infants are dependent on parenteral nutrition after birth .
OBJECTIVE	A parenteral lipid emulsion with a multicomponent composition may improve growth and neurodevelopment and may prevent liver injury , which is often observed in association with long-term parenteral nutrition with pure soybean oil .
OBJECTIVE	Our aim was to evaluate the safety and efficacy of a multicomponent lipid emulsion containing 30 % soybean oil , 30 % medium-chain triacylglycerol , 25 % olive oil , and 15 % fish oil compared with a conventional pure soybean oil emulsion in VLBW infants .
METHODS	We conducted a double-blind randomized controlled trial in VLBW infants randomized to parenteral nutrition with the multicomponent ( study group ) or pure soybean oil emulsion ( control group ) from birth at a dose of 2 to 3 g kg ( -1 ) day ( -1 ) until the infants were receiving full enteral nutrition .
METHODS	We assessed efficacy by growth rates and measuring plasma fatty acid profiles ( representative subset ) .
METHODS	Safety was evaluated by assessing hematologic and biochemical parameters , potentially harmful phytosterol concentrations ( same subset ) , and clinical neonatal outcome parameters .
RESULTS	Ninety-six infants were included ( subsets n = 21 ) .
RESULTS	The multicomponent emulsion was associated with higher weight and head circumference z scores during admission .
RESULTS	Plasma eicosapentaenoic acid and docosahexaenoic acid concentrations were higher in the study group .
RESULTS	The hematological , biochemical , and neonatal outcomes were not different between groups , whereas the plasma concentrations of phytosterols were higher in the control group .
CONCLUSIONS	The multicomponent lipid emulsion was well tolerated and associated with improved growth and higher plasma fatty acid profiles in VLBW infants in comparison with the pure soybean oil emulsion .

###25022705
BACKGROUND	Recently , intense pulsed light ( IPL ) and low-fluence Q-switched neodymium-doped yttrium aluminum ( LF-QS-Nd : YAG ) laser have been successfully used to treat melasma .
OBJECTIVE	To evaluate the effectiveness and safety of combined novel fractionated IPL ( IPL-F ) with LF-QS-Nd : YAG laser in patients with melasma .
METHODS	Twelve patients underwent 6 treatment sessions of concomitant IPL-F and LF-QS-Nd : YAG laser ( combination group ) , and 12 patients underwent 6 treatment session of IPL-F alone ( IPL only group ) .
METHODS	Partial melasma area and severity index ( MASI ) scores were evaluated by 2 dermatologists using digital photography .
RESULTS	In the combination group , the partial MASI score has significantly decreased by 47 % at 1 month after the treatment ( p < .05 ) and 50 % at 2 months after the last treatment ( p < .01 ) .
RESULTS	At 1 month and 2 months after the treatment , the decrease in the partial MASI score of the combination group was significantly larger than that of the IPL only group ( p < .05 ) .
RESULTS	In both groups , treatment with IPL-F and LF-QS-Nd : YAG laser was well tolerated .
CONCLUSIONS	Our results suggest that the combination of the IPL-F with LF-QS-Nd : YAG laser may be an effective and safe modality for melasma patients .

###25399542
OBJECTIVE	Although serrated polyps may be precursors of colorectal cancer ( CRC ) , prospective data on the long-term CRC risk in individuals with serrated polyps are lacking .
METHODS	In a population-based randomised trial , 12,955 individuals aged 50-64years were screened with flexible sigmoidoscopy , while 78220 individuals comprised the control arm .
METHODS	We used Cox models to estimate HRs with 95 % CIs for CRC among individuals with 1 large serrated polyp ( 10mm in diameter ) , compared with individuals with adenomas at screening , and to population controls , and multivariate logistic regression to assess polyp risk factors for CRC .
RESULTS	A total of 103 individuals had large serrated polyps , of which 81 were included in the analyses .
RESULTS	Non-advanced adenomas were found in 1488 individuals , advanced adenomas in 701 .
RESULTS	Median follow-up was 10.9 years .
RESULTS	Compared with the control arm , the HR for CRC was 2.5 ( 95 % CI 0.8 to 7.8 ) in individuals with large serrated polyps , 2.0 ( 95 % CI 1.3 to 2.9 ) in individuals with advanced adenomas and 0.6 ( 95 % CI 0.4 to 1.1 ) in individuals with non-advanced adenomas .
RESULTS	A large serrated polyp was an independent risk factor for CRC , adjusted for histology , size and multiplicity of concomitant adenomas ( OR 3.3 ; 95 % CI 1.3 to 8.6 ) .
RESULTS	Twenty-three large serrated polyps found at screening were left in situ for a median of 11.0 years .
RESULTS	None developed into a malignant tumour .
CONCLUSIONS	Individuals with large serrated polyps have an increased risk of CRC , comparable with individuals with advanced adenomas .
CONCLUSIONS	However , this risk may not be related to malignant growth of the serrated polyp .
BACKGROUND	The Norwegian Colorectal Cancer Screening trial is registered at clinicaltrials.gov ( NCT00119912 ) .

###24304731
BACKGROUND	Nonalcoholic fatty liver disease ( NAFLD ) is characterized by high intrahepatic triglyceride level .
BACKGROUND	It is associated with an increased prevalence of cardiovascular disease , independently of underlying cardiometabolic risk factors .
BACKGROUND	Metformin is used as a pharmacological treatment ; the adherence is low because of the presence of adverse effects .
BACKGROUND	Aerobic exercise could be an alternative therapy , but its effectiveness compared with metformin has not been established in the treatment of NAFLD .
BACKGROUND	The aim of this study was to establish the effectiveness of aerobic exercise and its influence in reducing cardiovascular risk in overweight or obese women with NAFLD .
METHODS	Sedentary women 25-60 years old with body mass index ( BMI ) > 24.9 kg/m2 and liver fat content < 50 HU , were randomly divided into two parallel groups : exercise group ( EG ) or metformin group ( MG ) .
METHODS	The EG performed an aerobic exercise program of 60 min/5 days / week at 60-85 % of heart rate reserve ; the MG took 1 g/day of metformin each morning .
METHODS	The duration of the intervention was 12 weeks .
METHODS	The liver fat content , metabolic and cardiorespiratory - fitness parameters were evaluated at the beginning and end of the program .
METHODS	The study complied with the Helsinki ethics codes for human research .
RESULTS	The study included a sample of 16 women , with 8 per group .
RESULTS	The treatments modified the liver fat content by 14.6 % ( CI95 % 0.92 , 28.36 ) and 10.37 % ( CI95 % -1.74 , 22.48 ) for the EG and MG , respectively .
RESULTS	In the EG , the insulin levels and HOMA-IR decreased ( P < 0.05 ) , and the cardiovascular fitness improved .
CONCLUSIONS	An aerobic exercise program of 12 weeks with a volume training of 300 min/week and a moderate to vigorous intensity ( 60-85 % VO2peak ) modified the liver fat content and improved cardiovascular risk factors during the intervention .
CONCLUSIONS	Exercise contributed to a holistic approach by modifying a number of the components of metabolic syndrome , cardiorespiratory-fitness , and cardiovascular risk .

###24985342
BACKGROUND	Brief interventions via the internet have been shown to reduce university students ' alcohol intake .
BACKGROUND	This study tested two smartphone applications ( apps ) targeting drinking choices on party occasions , with the goal of reducing problematic alcohol intake among Swedish university students .
METHODS	Students were recruited via e-mails sent to student union members at two universities .
METHODS	Those who gave informed consent , had a smartphone , and showed risky alcohol consumption according to the Alcohol Use Disorders Identification Test ( AUDIT ) were randomized into three groups .
METHODS	Group 1 had access to the Swedish government alcohol monopoly 's app , Promillekoll , offering real-time estimated blood alcohol concentration ( eBAC ) calculation ; Group 2 had access to a web-based app , PartyPlanner , developed by the research group , offering real-time eBAC calculation with planning and follow-up functions ; and Group 3 participants were controls .
METHODS	Follow-up was conducted at 7weeks .
RESULTS	Among 28574 students offered participation , 4823 agreed to join ; 415 were excluded due to incomplete data , and 1932 fulfilled eligibility criteria for randomization .
RESULTS	Attrition was 22.7-39 .3 percent , higher among heavier drinkers and highest in Group 2 .
RESULTS	Self-reported app use was higher in Group 1 ( 74 % ) compared to Group 2 ( 41 % ) .
RESULTS	Per-protocol analyses revealed only one significant time-by-group interaction , where Group 1 participants increased the frequency of their drinking occasions compared to controls ( p = 0.001 ) .
RESULTS	Secondary analyses by gender showed a significant difference among men in Group 1 for frequency of drinking occasions per week ( p = 0.001 ) , but not among women .
RESULTS	Among all participants , 29 percent showed high-risk drinking , over the recommended weekly drinking levels of 9 ( women ) and 14 ( men ) standard glasses .
CONCLUSIONS	Smartphone apps can make brief interventions available to large numbers of university students .
CONCLUSIONS	The apps studied using eBAC calculation did not , however , seem to affect alcohol consumption among university students and one app may have led to a negative effect among men .
CONCLUSIONS	Future research should : 1 ) explore ways to increase user retention , 2 ) include apps facilitating technical manipulation for evaluation of added components , 3 ) explore the effects of adapting app content to possible gender differences , and 4 ) offer additional interventions to high-risk users .
BACKGROUND	clinicaltrials.gov : NCT01958398 .

###25336915
OBJECTIVE	Evogliptin ( DA-1229 ) is a novel , potent , and selective dipeptidyl peptidase IV ( DPP-IV ) inhibitor in clinical development for the treatment of type 2 diabetes mellitus .
OBJECTIVE	This study aimed to investigate the pharmacokinetic and pharmacodynamic profiles and tolerability of evogliptin after repeated oral administration in healthy subjects .
METHODS	A block-randomized , double-blind , placebo-controlled , multiple-dose , dose-escalation study was performed in a total of 30 subjects .
METHODS	Repeated once-daily doses of 5 , 10 , or 20 mg evogliptin or the same doses of placebo were orally administered to ten subjects in each dosage group for 10 days .
METHODS	Subjects in each group were randomized to receive evogliptin or placebo with a ratio of 8:2 .
METHODS	Pharmacokinetics of evogliptin were evaluated , with its concentrations in serial plasma and urine samples collected following the first and last administrations .
METHODS	DPP-IV activity and glucagon-like peptide-1 , glucose , and insulin levels were quantified to evaluate evogliptin 's pharmacodynamics on the first and last dosing days .
RESULTS	All participants completed the study without any serious or severe adverse event .
RESULTS	The evogliptin plasma concentration reached its peak within 4-5 hours and decreased relatively slowly , with a terminal elimination half-life of 33-39 hours .
RESULTS	Repeated administration resulted in a 1.4 - to 1.5-fold accumulation .
RESULTS	Evogliptin 's systemic exposure and inhibition of plasma DPP-IV activity increased in a dose-dependent manner .
RESULTS	Inhibition of DPP-IV activity > 80 % was sustained over 24 hours in all evogliptin dose groups and provided an increase in postprandial active glucagon-like peptide-1 levels by 1.5 - to 2.4-fold .
RESULTS	Postprandial glucose levels in the evogliptin-treated groups were reduced 20 % -35 % compared to placebo , but were not accompanied by increased insulin levels .
CONCLUSIONS	Repeated administration of evogliptin in healthy subjects was well tolerated and exhibited linear pharmacokinetics within the 5-20 mg dose range .
CONCLUSIONS	A once-daily regimen of 5-20 mg evogliptin effectively inhibited DPP-IV activity .

###24829298
BACKGROUND	Taurine 's role in bile acid metabolism and anti-inflammatory activity could exert a protective effect on hepatobiliary complications associated with parenteral nutrition ( PN ) .
BACKGROUND	In this study , the effects of 2 amino acid solutions , with and without taurine , on liver function administered to nonacutely ill postsurgical patients as part of a short-term PN regimen were prospectively compared .
METHODS	Adult patients randomly received ( double-blind ) Tauramin 10 % or a standard PN solution without taurine as the control ( 1.5 g amino acid/kg body weight [ bw ] / d ; infusion rate of 4 mg glucose/kg bw/d ) for a period of 5-30 days .
METHODS	- Glutamyl transpeptidase ( GGT ) and other indicators of liver function , glucose metabolism , lipid profile , inflammation markers , and treatment safety data were collected .
RESULTS	Thirty-five patients receiving taurine PN and 39 receiving control PN were enrolled ( intention-to-treat [ ITT ] population ) .
RESULTS	Most patients ( n = 62 ) discontinued after day 7 of follow-up ( per-protocol [ PP ] population : n = 24 and n = 27 , respectively ) .
RESULTS	ITT patients with high GGT values after 5 days of PN comprised 68.6 % and 64.1 % , respectively .
RESULTS	The mean change in GGT values with respect to the baseline values was 167 192 and 157 185 IU/L , respectively .
RESULTS	Low-density lipoprotein ( LDL ) cholesterol levels after 7 days of PN were significantly decreased in the taurine PN group of PP patients ( -2.83 30.9 vs 23.9 27.0 mg/dL for control PN ; P < .05 ) .
RESULTS	None of the adverse events reported ( taurine PN : n = 6 ; control PN : n = 7 ) were treatment related .
CONCLUSIONS	PN solutions with and without taurine had similar effects on liver function parameters , except for an LDL reduction in PN with taurine , when administered to nonacutely ill postsurgical patients in the short term ( 5-7 days ) .

###25185211
BACKGROUND	Deep brain stimulation ( DBS ) improves motor symptoms in Parkinson 's disease ( PD ) , but questions remain regarding neuropsychological decrements sometimes associated with this treatment , including rates of statistically and clinically meaningful change , and whether there are differences in outcome related to surgical target .
METHODS	Neuropsychological functioning was assessed in patients with Parkinson 's disease ( PD ) at baseline and after 6 months in a prospective , randomised , controlled study comparing best medical therapy ( BMT , n = 116 ) and bilateral deep brain stimulation ( DBS , n = 164 ) at either the subthalamic nucleus ( STN , n = 84 ) or globus pallidus interna ( GPi , n = 80 ) , using standardised neuropsychological tests .
METHODS	Measures of functional outcomes were also administered .
RESULTS	Comparison of the two DBS targets revealed few significant group differences .
RESULTS	STN DBS was associated with greater mean reductions on some measures of processing speed , only one of which was statistically significant in comparison with stimulation of GPi .
RESULTS	GPi DBS was associated with lower mean performance on one measure of learning and memory that requires mental control and cognitive flexibility .
RESULTS	Compared to the group receiving BMT , the combined DBS group had significantly greater mean reductions at 6-month follow-up in performance on multiple measures of processing speed and working memory .
RESULTS	After calculating thresholds for statistically reliable change from data obtained from the BMT group , the combined DBS group also displayed higher rates of decline in neuropsychological test performance .
RESULTS	Among study completers , 18 ( 11 % ) study participants receiving DBS displayed reliable decline by multiple indicators in two or more cognitive domains , a significantly higher rate than in the BMT group ( 3 % ) .
RESULTS	This multi-domain cognitive decline was associated with less beneficial change in subjective ratings of everyday functioning and quality of life ( QOL ) .
RESULTS	The multi-domain cognitive decline group continued to function at a lower level at 24-month follow-up .
CONCLUSIONS	In those with PD , the likelihood of significant decline in neuropsychological functioning increases with DBS , affecting a small minority of patients who also appear to respond less optimally to DBS by other indicators of QOL .
BACKGROUND	NCT00056563 and NCT01076452 .

###25030801
BACKGROUND	Posttraumatic stress disorder ( PTSD ) and alcoholism are frequently comorbid , suggesting the possibility of overlapping neural substrates .
BACKGROUND	The neurokinin 1 ( NK1 ) receptor for substance P ( SP ) has been implicated in both stress - and alcohol-related behaviors .
BACKGROUND	The NK1 antagonist aprepitant , clinically available as a treatment for chemotherapy-induced nausea , offers a tool to probe a potential role of the SP/NK1 system in comorbid PTSD and alcoholism .
OBJECTIVE	The aim of this study is to evaluate the efficacy of aprepitant for treatment of comorbid PTSD and alcoholism .
METHODS	Fifty-three patients with PTSD and alcoholism were admitted for 4 weeks to an inpatient unit at the NIH Clinical Center and randomized to double-blind aprepitant ( 125 mg/day ; based on PET studies reporting > 90 % central receptor occupancy at this dose ) or placebo .
METHODS	After reaching steady state , subjects were assessed for PTSD symptom severity , behavioral and neuroendocrine responses to stress and alcohol cues , and functional magnetic resonance imaging ( fMRI ) responses to stimuli with positive or negative emotional valence .
RESULTS	Aprepitant treatment had no effect on PTSD symptoms or subjective or physiological responses to stress or alcohol cues .
RESULTS	However , aprepitant robustly potentiated ventromedial prefrontal cortex ( mPFC ) fMRI responses to aversive visual stimuli .
CONCLUSIONS	Despite the lack of effect on PTSD symptoms and responses to stress/alcohol cues , NK1 antagonism activated the ventral mPFC , an area considered hypoactive in PTSD , during exposure to aversive stimuli .
CONCLUSIONS	Because this brain area is critically important for extinction of fear memories and in alcohol craving and relapse , our finding suggests that NK1 antagonism might be a useful pharmacological treatment to enhance extinction-based cue-exposure therapies .

###24823430
OBJECTIVE	The purpose of this study is to investigate the impact of cognitive group therapy and happiness training objectively in the local cerebral blood flow of patients with major depression ( MD ) .
METHODS	The present research is semi-experimental to pre - and post-test with a control group .
METHODS	Three groups were formed , and this number was incorporated in each group : 12 patients were chosen randomly ; the first group of depressed patients benefited from the combination of pharmacotherapy and sessions of cognitive group therapy ; the second group used a combination of pharmacotherapy and sessions of happiness training ; and a third group used only pharmacotherapy .
METHODS	We compared cognitive-behavioural therapy and happiness training efficacy with only pharmacotherapy in MD patients .
METHODS	We performed brain perfusion SPECT in each group , before and after each trial .
RESULTS	The study was conducted on 36 patients with MD ( 32 women and 4 men ; mean age : 41.22 9.08 ; range : 27-65 years ) .
RESULTS	There were significant differences regarding the two trial effects into two experimental groups ( p < 0/001 ) before and after trials , while such differences were not significant in the control group ( p > 0.05 ) .
RESULTS	In addition , there was significant difference among the regional cerebral blood flow in the frontal and prefrontal regions into two experimental groups before and after trials ( p < 0/001 ) , while such differences were not significant in the control group ( p > 0.05 ) .
CONCLUSIONS	This study demonstrated decreased cerebral perfusion in the frontal regions in MD patients , which increased following cognitive group therapy and happiness training .
CONCLUSIONS	Because of its availability , low costs , easy performance , and the objective semi-quantitative information supplied , brain perfusion SPECT scanning might be useful to assess the diagnosis and therapy efficacy .
CONCLUSIONS	Further exploration is needed to validate its clinical role .

###24710856
BACKGROUND	In cases of exacerbation or crisis , myasthenia gravis ( MG ) patients can be treated with intravenous immunoglobulin ( IVIg ) , plasmapheresis , or immunoadsorption .
BACKGROUND	However , IVIg efficacy data in maintenance treatment are sparse .
METHODS	We prospectively observed 16 index patients with chronic and insufficiently controlled MG under standard immunosuppressant therapy and symptomatic treatment .
METHODS	The IVIg treatment response was measured using changes in quantitative myasthenia gravis ( QMG ) score and surrogates .
METHODS	Based on these results , a sample size calculation for a future randomized , controlled trial ( RCT ) was simulated .
RESULTS	There was an enduring decline in QMG score and other parameters of about 50 % under IVIg maintenance treatment .
RESULTS	RCT sample size calculation results in 73 or 33 patients per arm to detect at least a 20 % vs. 30 % clinical difference in QMG score .
CONCLUSIONS	We recommend using the QMG score as a primary endpoint for an RCT of IVIg maintenance for chronic MG .

###24456065
OBJECTIVE	To evaluate the safety and efficacy of osmotic-controlled release oral delivery system ( OROS ) methylphenidate ( MPH ) HCl in adults with attention-deficit/hyperactivity disorder ( ADHD ) .
METHODS	In this study , 284 adults with ADHD were randomized to OROS MPH or placebo .
METHODS	During the 4-week titration period , patients were titrated from a starting dose of 18 mg once daily to an individually-optimized dose of up to 72 mg once daily in weekly 18-mg increments .
METHODS	Patients continued on their individualized dose during the 4-week efficacy assessment period .
METHODS	The primary efficacy endpoint was change in DSM-IV Total ADHD Symptoms subscale score of Conners ' Adult ADHD Rating Scale-Observer : Screening Version ( CAARS-O : SV ) from baseline to endpoint .
RESULTS	The mean change in DSM-IV Total ADHD Symptoms subscale score of CAARS-O : SV was significantly larger with OROS MPH compared with placebo ( P < 0.0001 , ANCOVA ) .
RESULTS	Similar results were observed for the majority of secondary endpoints , including CAARS-O : SV total score and other subscale scores .
RESULTS	Although treatment-emergent adverse events were reported more frequently in the OROS MPH group ( 81.8 % ) versus the placebo group ( 53.9 % ) , OROS-MPH showed a well-tolerated safety profile overall .
CONCLUSIONS	OROS MPH in a dose range of 18-72 mg once daily was effective and well-tolerated in adult patients with ADHD .

###25965708
BACKGROUND	In patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction , ischemic postconditioning has been shown to reduce infarct size , but the effect on clinical outcome has not been tested in a large randomized trial .
BACKGROUND	In addition , deferring stent implantation in the infarct-related lesion 1 to 3 days after acute opening of the infarct-related artery could have protective effects , by reducing the risk of injury caused by distal embolization and microvascular obstruction .
BACKGROUND	Finally , a considerable fraction of patients present with lesions in other coronary artery branches than the infarct-related artery .
BACKGROUND	Whether a strategy of complete or partial revascularization of these patients should be preferred remains uncertain .
METHODS	The DANAMI 3 trial program was designed to investigate 3 different randomized treatment strategies in patients with ST-segment elevation myocardial infarction : ( 1 ) ischemic postconditioning versus conventional treatment with a primary end point of death and hospitalization for heart failure ; ( 2 ) deferring stent implantation in the infarct-related lesion versus conventional treatment with a primary end point of death , hospitalization for heart failure , reinfarction , and repeat revascularization ; and ( 3 ) treatment of the culprit lesion only versus fractional flow reserve-guided complete revascularization in patients with multivessel disease , with a primary end point of death , reinfarction , and repeat revascularization .
CONCLUSIONS	The DANAMI 3 trial program will determine whether either of 2 approaches to reduce reperfusion injury and distal microvascular obstruction with postconditioning or deferred stent implantation will translate into improved clinical outcome and whether patients with multivessel disease undergoing primary percutaneous coronary intervention will benefit from a strategy of complete or partial revascularization .

###24457277
OBJECTIVE	We aimed to investigate whether thrombus aspiration could preserve the index of microcirculatory resistance ( IMR ) after primary percutaneous coronary intervention ( PCI ) in patients with ST-elevation myocardial infarction ( STEMI ) .
RESULTS	Sixty-three patients with STEMI were randomised into two groups : primary PCI after thrombus aspiration ( aspiration group , n = 33 ) and primary PCI without thrombus aspiration ( non-aspiration group , n = 30 ) .
RESULTS	IMR was measured using a pressure-temperature sensor-tipped coronary wire .
RESULTS	Echocardiography was performed at baseline and at six-month follow-up .
RESULTS	No significant differences in baseline ejection fraction ( EF , 47.38.5 % vs. 49.57.8 % , p = 0.281 ) and baseline wall motion score index ( WMSI , 1.450.31 vs. 1.370.27 , p = 0.299 ) were observed between the two groups .
RESULTS	However , significant differences in IMR ( 23.510.2 U vs. 34.221.7 U , p = 0.018 ) , % E2 % 88 % 86EF ( follow-up EF - baseline EF ; 3.334.6 % vs. 0.731.9 % , p = 0.005 ) , and % E2 % 88 % 86WMSI ( follow-up WMSI - baseline WMSI ; -0.1210.16 vs. -0.0040.07 , p = 0.001 ) were observed between the two groups .
CONCLUSIONS	Thrombus aspiration as an adjunctive method to primary PCI for STEMI may preserve microvascular integrity and have beneficial effects on myocardial microcirculation .

###24612588
OBJECTIVE	The purpose of this study was to test the feasibility of a parent-briefing intervention for parents of hospitalized children with complex healthcare needs .
METHODS	A phase I , single-group , posttest study .
METHODS	There were 18 physicians , 25 nurses , and 31 parents who participated in the study .
METHODS	Participants were asked to sit while carrying out the briefings with parents .
METHODS	Parents and clinicians completed a feasibility questionnaire post briefings .
RESULTS	Sixty-eight briefings were carried out .
RESULTS	Parents and nurses evaluated the briefings in a favorable manner , whereas physicians ' ratings were mixed .
CONCLUSIONS	Further inquiry is recommended to understand the effects of a structured communication intervention on parent-professional decision-making practices .

###25131892
BACKGROUND	Sometimes a written advance directive contradicts the opinion of a health care proxy .
BACKGROUND	How this affects doctors ' decision making is unknown .
OBJECTIVE	To quantify the influence of contradictory instructions on doctors ' decisions .
METHODS	All the generalists and internists in French-speaking Switzerland were mailed the questionnaire .
METHODS	Respondents ( 43.5 % ) evaluated three vignettes that described medical decisions for incapacitated patients .
METHODS	Each vignette was produced in four versions : one with an advance directive , one with a proxy opinion , one with both , and one with neither ( control ) .
METHODS	In the first vignette , the directive and proxy agreed on the recommendation to forgo a medical intervention ; in the second , the advance directive opposed , but the proxy favored the intervention ; and in the third , the roles were reversed .
METHODS	Each doctor received one version of each vignette , attributed at random .
METHODS	The outcome variables were the doctor 's decision to forgo the medical intervention and the rating of the decision as difficult .
RESULTS	Written advance directives and proxy opinions significantly influenced doctors ' decision making .
RESULTS	When both were available and concordant , they reinforced each other ( odds ratio [ OR ] of forgoing intervention 35.7 , P < 0.001 compared with no instruction ) .
RESULTS	When the directive and proxy disagreed , the resulting effect was to forgo the intervention ( ORs 2.1 and 2.2 for the two discordant vignettes , both P < 0.001 ) .
RESULTS	Discordance between instructions was associated with increased odds of doctors rating the decision as difficult ( both ORs 2.0 , P 0.001 ) .
CONCLUSIONS	Contradictions between advance directives and proxy opinions result in a weak preference for abstention from treatment and increase the difficulty of the decision .

###24369366
OBJECTIVE	To investigate the feasibility of a computer-based reading intervention completed by patients diagnosed with a brain tumor .
METHODS	Patients were randomized to the intervention ( n = 43 ) or standard of care group ( n = 38 ) .
METHODS	The intervention consisted of 30 sessions using Fast ForWord exercises in a game-like format .
METHODS	Change in reading decoding scores over time since diagnosis was examined .
METHODS	Gender , race , parent education , parent marital status , and age at diagnosis were examined as covariates .
RESULTS	17 patients ( 39.5 % ) were able to complete the target goal of 30 intervention sessions .
RESULTS	Females had significantly greater training time than males ( p = .022 ) .
RESULTS	Age at diagnosis was associated with average training time/session for females ( r = .485 , p = .041 ) .
RESULTS	No significant differences were found in reading scores between the randomized groups .
CONCLUSIONS	The study was well accepted by families and adherence by patients undergoing radiation therapy for medulloblastoma was moderate .
CONCLUSIONS	Suggestions for improved methodology are discussed .

###25088637
OBJECTIVE	To assess the efficacy of a heparin-surface-modified ( HSM ) hydrophobic acrylic intraocular lens ( IOL ) ( EC-1YH PAL ) and the same IOL without heparin coating ( EC-1Y-PAL ) by the flare and cell intensity in the anterior chamber after uneventful cataract surgery .
METHODS	Department of Ophthalmology , Paracelsus Medical University Salzburg , Austria .
METHODS	Comparative case series .
METHODS	Routine phacoemulsification with randomized implantation of an HSM IOL in 1 eye ( HSM IOL group ) and an uncoated IOL ( uncoated IOL group ) in the fellow eye was performed .
METHODS	Postoperative inflammation was assessed objectively using a laser flare-cell meter ( FM-600 ) preoperatively as well as 1 day and 1 and 3 months postoperatively .
METHODS	Aqueous cells in the anterior chamber , distance visual acuities , and subjective manifest refraction were also evaluated at each visit .
RESULTS	One hundred eyes ( 50 patients ) were enrolled .
RESULTS	In both groups , the mean flare values increased significantly from preoperatively to 1 day postoperatively ( P < .001 ) and nearly reached preoperative values by 3 months postoperatively .
RESULTS	One day postoperatively , the mean flare value was statistically significantly lower in the HSM IOL group ( 14.92 photons per millisecond [ ph/ms ] 7.47 [ SD ] ) than in the uncoated IOL group ( mean 16.73 7.81 ph/ms ) ( P = .04 ) ; there was no statistically significant difference between groups 1 and 3 months postoperatively ( both P > .58 ) .
RESULTS	The HSM IOL group had a greater and quicker decrease in aqueous cells , reaching statistical significance 1 month postoperatively ( P = .01 ) .
CONCLUSIONS	The HSM IOL showed a significant lower inflammatory reaction in the early postoperative stage with a faster disappearance of inflammatory signs .
BACKGROUND	No author has a financial or proprietary interest in any material or method mentioned .

###25199313
BACKGROUND	Propofol is commonly used for induction and maintenance of anesthesia , but pain at the site of intravenous injection is a clinical problem .
BACKGROUND	We studied the effectiveness of local cooling and pretreatment with lidocaine for prevention of injection pain of propofol .
METHODS	A total of 226 adult patients scheduled to receive general anesthesia were assigned randomly to four groups : a control group receiving no prophylactic intervention , a cooling group receiving topical cooling , a lidocaine group receiving 1 mg x kg ( -1 ) lidocaine , and a lidocaine plus cooling group receiving topical cooling and 1 mg x kg ( -1 ) lidocaine .
METHODS	A 20 gauge intravenous catheter was inserted into the peripheral vein at the radial side of the forearm .
METHODS	After prophylactic intervention had been performed , 1-2 mg x kg ( -1 ) MCT/LCT propofol was injected .
METHODS	Patients were asked to grade the pain as none , mild , moderate , or severe .
RESULTS	The incidence of propofol-induced pain was significantly higher in the control group ( 39 % ) than in the other three groups ( 17 % in the cooling group , 16 % in the lidocaine group and 8 % in the lidocaine plus cooling group ) .
RESULTS	However , there were no significant differences between the three groups with different prophylactic interventions .
CONCLUSIONS	The results suggest that cooling and pretreatment with lidocaine reduce the incidence of pain upon propofol injection .

###25189213
BACKGROUND	Diabetes mellitus and heart failure frequently coexist .
BACKGROUND	However , few diabetes mellitus trials have prospectively evaluated and adjudicated heart failure as an end point .
RESULTS	A total of 16492 patients with type 2 diabetes mellitus and a history of , or at risk of , cardiovascular events were randomized to saxagliptin or placebo ( mean follow-up , 2.1 years ) .
RESULTS	The primary end point was the composite of cardiovascular death , myocardial infarction , or ischemic stroke .
RESULTS	Hospitalization for heart failure was a predefined component of the secondary end point .
RESULTS	Baseline N-terminal pro B-type natriuretic peptide was measured in 12301 patients .
RESULTS	More patients treated with saxagliptin ( 289 , 3.5 % ) were hospitalized for heart failure compared with placebo ( 228 , 2.8 % ; hazard ratio , 1.27 ; 95 % confidence intercal , 1.07-1 .51 ; P = 0.007 ) .
RESULTS	Corresponding rates at 12 months were 1.9 % versus 1.3 % ( hazard ratio , 1.46 ; 95 % confidence interval , 1.15-1 .88 ; P = 0.002 ) , with no significant difference thereafter ( time-varying interaction , P = 0.017 ) .
RESULTS	Subjects at greatest risk of hospitalization for heart failure had previous heart failure , an estimated glomerular filtration rate 60 mL/min , or elevated baseline levels of N-terminal pro B-type natriuretic peptide .
RESULTS	There was no evidence of heterogeneity between N-terminal pro B-type natriuretic peptide and saxagliptin ( P for interaction = 0.46 ) , although the absolute risk excess for heart failure with saxagliptin was greatest in the highest N-terminal pro B-type natriuretic peptide quartile ( 2.1 % ) .
RESULTS	Even in patients at high risk of hospitalization for heart failure , the risk of the primary and secondary end points were similar between treatment groups .
CONCLUSIONS	In the context of balanced primary and secondary end points , saxagliptin treatment was associated with an increased risk or hospitalization for heart failure .
CONCLUSIONS	This increase in risk was highest among patients with elevated levels of natriuretic peptides , previous heart failure , or chronic kidney disease .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01107886 .

###25455610
BACKGROUND	Sturge-Weber syndrome ( SWS ) is characterized by port-wine stains ( PWS ) affecting the face , eyes , and central nervous system .
BACKGROUND	Pulsed dye laser ( PDL ) is the standard treatment for PWS .
BACKGROUND	Unfortunately , recurrence is frequent because of reformation and reperfusion of blood vessels .
OBJECTIVE	We sought to assess the clinical efficacy of topical rapamycin combined with PDL in PWS of patients with SWS .
METHODS	We conducted a phase II , randomized , double-blind , intraindividual placebo-controlled , clinical trial .
METHODS	We recruited 23 patients with SWS and facial PWS ( 12 women ; median age 33 years , age range 17-65 years ) from the University Clinic of Navarra , Spain .
METHODS	Four interventions were evaluated : placebo , PDL + placebo , rapamycin , and PDL + rapamycin .
METHODS	Clinical and histologic responses were evaluated using a chromatographic computerized system , spectrometry , and histologic analyses at 6 , 12 , and 18 weeks after the intervention .
RESULTS	PDL + rapamycin yielded the lowest digital photographic image score and the lowest percentage of vessels in histologic analysis , and showed a statistically significant improvement compared with the other interventions .
RESULTS	The treatment was generally well tolerated .
CONCLUSIONS	PDL was only applied to the lateral parts of the PWS area .
CONCLUSIONS	Topical rapamycin associated with PDL seems to be an effective treatment for PWS in patients with SWS .

###25734733
OBJECTIVE	Sedative premedication is widely administered before surgery , but little clinical evidence supports its use .
OBJECTIVE	To assess the efficacy of sedative premedication on perioperative patient experience .
METHODS	A randomized clinical trial , the PremedX study , enrolled 1062 adult patients who were younger than 70 years and had been scheduled for various elective surgeries under general anesthesia at 5 French teaching hospitals ( in Marseille , Montpellier , Nimes , and Nice ) between January 2013 and June 2014 .
METHODS	Neurosurgery , obstetrical , cardiac , and outpatient surgery were excluded .
METHODS	Patients were randomized to 3 groups of 354 participants each to receive 2.5 mg of lorazepam , no premedication , or placebo .
METHODS	The primary outcome was perioperative patient experience assessed 24 hours after surgery with a validated questionnaire ( Evaluation du Vcu de l'Anesthsie Generale ; EVAN-G ) describing 6 domains of satisfaction and a global index ( score range , 0-100 ; high scores represent high satisfaction ) ; secondary outcomes included time to extubation and early cognitive recovery .
METHODS	A subgroup analysis was planned a priori in patients with a high level of preoperative anxiety .
RESULTS	Premedication with lorazepam did not improve the EVAN-G mean global index for overall level of patient satisfaction ( 72 [ 95 % CI , 70-73 ] ; n = 330 ) compared with no premedication ( 73 [ 95 % CI , 71-74 ] ; n = 319 ) or placebo ( 71 [ 95 % CI , 70-73 ] ; n = 322 ) ( P = .38 ) .
RESULTS	Among patients with heightened preoperative anxiety , there were no significant differences found in the EVAN-G mean global index between the lorazepam group ( 68 [ 95 % CI , 65-72 ] ; n = 87 ) and the no premedication group ( 73 [ 95 % CI , 69-77 ] ; n = 57 ) or the placebo group ( 70 [ 95 % CI , 67-72 ] ; n = 87 ) ( P = .18 ) .
RESULTS	Time to extubation was 17 minutes ( 95 % CI , 14-20 minutes ) in the lorazepam group , 12 minutes ( 95 % CI , 11-13 minutes ) for the no premedication group , and 13 minutes ( 95 % CI , 12-14 minutes ) for the placebo group ( P < .001 ) and the rate of early cognitive recovery was 51 % ( 95 % CI , 45 % -56 % ) , 71 % ( 95 % CI , 66 % -76 % ) , and 64 % ( 95 % CI , 59 % -69 % ) , respectively ( P < .001 ) .
CONCLUSIONS	Among patients undergoing elective surgery under general anesthesia , sedative premedication with lorazepam compared with placebo or no premedication did not improve the self-reported patient experience the day after surgery , but was associated with modestly prolonged time to extubation and a lower rate of early cognitive recovery .
CONCLUSIONS	The findings suggest a lack of benefit with routine use of lorazepam as sedative premedication in patients undergoing general anesthesia .
BACKGROUND	clinicaltrials.gov Identifier : NCT01901003 .

###24561636
OBJECTIVE	To investigate the effectiveness of a neck strengthening program on the isometric neck strength profile of male rugby union players .
METHODS	Controlled laboratory study .
METHODS	Professional rugby union club .
METHODS	Fifteen professional and 10 semiprofessional rugby union players .
METHODS	The 15 professional players undertook a 5-week neck strengthening intervention , which was performed twice per week , whereas the 10 semiprofessional players acted as the control group .
METHODS	Isometric strength of the neck musculature was tested using a hand-held dynamometer , for flexion ( F ) , extension ( E ) , left-side flexion ( LSF ) , and right-side flexion ( RSF ) .
METHODS	Preintervention and postintervention evaluations were undertaken .
RESULTS	No significant between-group differences in isometric neck strength were noted preintervention .
RESULTS	A significant main effect for time was observed ( P < 0.05 ) , whereby the intervention group increased isometric neck strength in all planes after the 5-week intervention ( F preintervention = 334.45 39.31 N vs F postintervention 396.05 75.55 N ; E preintervention = 606.19 97.34 vs E postintervention = 733.88 127.16 N ; LSF preintervention = 555.56 88.34 N vs LSF postintervention = 657.14 122.99 N ; RSF preintervention = 570.00 106.53 N vs RSF postintervention = 668.00 142.18 N ) .
RESULTS	No significant improvement in neck strength was observed for control group participants .
CONCLUSIONS	The results of the present study indicate that a 5-week neck strengthening program improves isometric neck strength in rugby union players , which may have implications for injury prevention , screening , and rehabilitation .
CONCLUSIONS	The strengthening program described in the present study may facilitate rehabilitation specialists in the development of neck injury prevention , screening , and rehabilitation protocols .

###24655439
BACKGROUND	In the ` Tailored Implementation for Chronic Diseases ( TICD ) ' project , five tailored implementation programs to improve healthcare delivery in different chronic conditions have been developed .
BACKGROUND	These programs will be evaluated in distinct cluster-randomized controlled trials .
BACKGROUND	This protocol describes the process evaluation across these trials , which aims to identify determinants of change in chronic illness care , to examine the validity of the tailoring methods that were applied , and to analyze the association of implementation activities and the effectiveness of the program .
METHODS	A multilevel approach was used to develop five tailored implementation interventions .
METHODS	In order to guide the process evaluation in five distinct trials , the study protocols for the cluster randomized trials and the related process evaluations were developed simultaneously and iteratively .
RESULTS	The process evaluation comprises three main components : a structured survey with health professionals in the trials , semi-structured interviews with a purposeful sample of this study population , and standardized documentation of organizational practice characteristics .
RESULTS	Norway will only conduct the qualitative part of the analysis because the survey and documentation of practice characteristics are considered to be not feasible .
RESULTS	The evaluation is guided by ` logic models ' of the implementation programs : frameworks that specify the linkages between the strategies used , the determinants addressed by tailoring , and the anticipated outcomes .
RESULTS	Standardization of measures across trials is sought to facilitate analysis of aggregated data from the trials .
CONCLUSIONS	This process evaluation will need to find a balance between standardization of methods across trials and the tailoring of measures to the specificities of each trial .

###25794112
BACKGROUND	Therapeutic hypothermia is the standard of care after perinatal asphyxia .
BACKGROUND	Preclinical studies show 50 % xenon improves outcome , if started early .
METHODS	During a 32-patient study randomized between hypothermia only and hypothermia with xenon , 5 neonates were given xenon during retrieval using a closed-circuit incubator-mounted system .
RESULTS	Without xenon availability during retrieval , 50 % of eligible infants exceeded the 5-hour treatment window .
RESULTS	With the transportable system , 100 % were recruited .
RESULTS	Xenon delivery lasted 55 to 120 minutes , using 174 mL/h ( 117.5-193 .2 ) ( median [ interquartile range ] ) , after circuit priming ( 1300 mL ) .
CONCLUSIONS	Xenon delivery during ambulance retrieval was feasible , reduced starting delays , and used very little gas .

###24838056
BACKGROUND	Detrimental effects of right ventricular ( RV ) apical pacing have directed the interest toward alternative pacing sites such as the RV mid-septum .
BACKGROUND	As safety data are scarce for implantable cardioverter defibrillator ( ICD ) recipients the study aims to evaluate ICD lead performance in the mid-septal position .
RESULTS	A total of 299 ICD recipients ( 79 % male , aged 65.2 12.1 years , 83 % primary prevention of sudden cardiac death ) were randomized to receive the RV ICD electrode either in a mid-septal ( n = 145 ) or apical ( n = 154 ) location .
RESULTS	Event-free survival was evaluated at 3 ( primary endpoint ) and 12 months ( secondary endpoint ) .
RESULTS	Events included a composite of lead revision , suboptimal right ventricular electrode performance ( including defibrillation thresholds ( DFT ) > 25 J ) or lead position not in accordance with randomized location .
RESULTS	Event-free survival at 3 ( 12 ) months was observed in 80.6 % ( 72.3 % ) of patients randomized to a mid-septal and in 82.2 % ( 72.1 % ) of patients randomized to an apical lead position , p = 0.726 ( p = 0.969 ) .
RESULTS	Pre-defined margins for non-inferiority were not reached at 3 or 12 months .
RESULTS	High DFT was found in 7 patients ( 5.0 % ) of the mid-septal and in 3 ( 2.2 % ) patients of the apical group ( p = 0.209 ) .
CONCLUSIONS	In ICD recipients electrode positioning to the RV mid-septum or the RV apex results in slightly different rates concerning the survival free of lead revision , suboptimal right ventricular electrode performance or non-randomized lead position .
CONCLUSIONS	Non-inferiority of the mid-septal lead location can not be concluded .
CONCLUSIONS	This should be taken into consideration when a mid-septal lead position is pursued .
BACKGROUND	ClinicalTrials.gov identifier NCT00745745 .

###25314773
OBJECTIVE	To make a randomized comparison of 2 consolidation treatment options ( two patient groups ) : 2 cycles of cytarabine in average ( Ig/m2 in Group 2 ) and standard ( 100 mg/mi2 in Group 1 ) doses in combination with idarubicin ( 8-12 mg/m2 ) and mitoxantrone ( 10 mg/m2 ) , after two 7 +3 induction cycles of daunorubicin ( 60 mg/mi2 ) and subsequent 6 cycles of maintenance therapy .
METHODS	In January 2010 to October 2013 , a Russian multicenter trial was conducted to treat patients with acute myeloid leukemias ( AML ) in accordance with the AML-01 .10 protocol ( ClinicalTrials.gov Identifier : NCT01587430 ) .
METHODS	The trial enrolled 243 AML patients from 21 centers , including 71 patients ( median age 38 years ) from the State Hematology Center , Ministry of Health of the Russian Federation ; 35 and 36 patients were randomized to Groups 1 and 2 , respectively .
METHODS	The randomized groups were balanced by basic clinical and laboratory parameters .
METHODS	Favorable , intermediate , and high cytogenetic prognoses were in 14 ( 21.9 % ) , 40 ( 62.5 % ) , and 10 ( 15.6 % ) patients , respectively .
RESULTS	Prior to treatment , 2 patients died ; one patient refused treatment .
RESULTS	Fifty-eight ( 85.3 % ) of the 68 patients achieved complete remission ( CR ) ; early deaths was in 2 ( 2.9 % ) and resistance in 8 ( 11.8 % ) .
RESULTS	Four ( 6.9 % ) patients died during CR .
RESULTS	Protocol deviations ( doses , intervals , and the number of cycles ) were recorded in 12 ( 20.7 % ) of the 58 patients .
RESULTS	Other 8 ( 11.8 % ) patients were switched to low-dose cytarabine because of complications , withdrawn from the protocol and not included into the analysis of randomized comparison .
RESULTS	Twenty allogeneic bone marrow transplantations ( allo-BMT ) ( 7 related , 12 unrelated , and 1 haploidentical ) were performed ; of them 15 allo-BMTs were done during first CR .
RESULTS	In the 68 patients , 3-year overall survival ( OS ) was 45.6 % ; relapse-free survival ( RFS ) was 41.5 % .
RESULTS	OS was 64.6 % in Group 1 and 58.3 % in Group 2 ; RFS was 62 and 38.8 % in Groups 1 and 2 , respectively ( p > 0.5 ) .
RESULTS	In the favorable , intermediate , and high prognosis groups , OS was 79.5 , 60 , and 31.1 % and RFS was 81.8 , 41.3 , and 33.3 % , respectively ( p = 0.1 ) .
RESULTS	The consolidation treatment option unchanged survival rates in the above risk groups .
RESULTS	Unachieved CR after the first cycle considerably decreased RFS ( 33.9 % versus 60 % ) and served as an indication for allo-BMT during first CP ( RFS without BMT was 0 ; that with BMT was 78 % ) .
CONCLUSIONS	No differences were found between both consolidation options according to long-term results .
CONCLUSIONS	Protocol deviations were recorded in one-third of the patients .
CONCLUSIONS	While implementing the protocol , the efficiency of treatment was high .
CONCLUSIONS	Allo-BMT during first CR substantially increased RFS if CP was not achieved after the first cycle .

###25275268
OBJECTIVE	We investigate the effect of 6 months aerobic training alone or in combination with diet on adiponectin in circulation and in adipose abdominal tissue ( AT ) in obese women .
METHODS	Twenty obese subjects were randomized into a 24 weeks intervention : 1 ) training ( TR ) and 2 ) training and diet ( TRD ) .
METHODS	Blood samples were collected at baseline , after 12 wk and 24 wk .
METHODS	AT biopsies were obtained only at baseline and after 24 wk .
RESULTS	In the TRD group the fat loss was after 12 wk -13.74 % ( p < 0.01 ) and after 24 wk -21.82 % ( p < 0.01 ) with no changes in the TR group .
RESULTS	After 12 and 24 wk , VO2max was increased by 21.81-39 .54 % ( p < 0.05 ) in the TRD group and 18.09-40 .95 % in the TR group ( p < 0.05 ) .
RESULTS	After 12 wk , plasma adiponectin was raised only in the TRD group ( 55.8 % , p < 0.05 ) .
RESULTS	After 24 weeks , circulating adiponectin was elevated by 110.4 % ( p < 0.01 ) in the TRD group and by 27 % ( p < 0.05 ) in the TR group .
RESULTS	In AT biopsies , subjects in the TRD and TR groups exhibited a significant increase in adiponectin ( p < 0.05 and p < 0.01 , respectively ) .
RESULTS	The two indices HOMA-IR and HOMA-AD for assessing insulin resistance were strongly affected by protocols .
RESULTS	HOMA-IR decreased ( p < 0.05 ) only after 24 wk in the TRD group .
RESULTS	HOMA-AD increased in both groups after 12 ( p < 0.05 ) and 24 wk ( p < 0.01 ) .
CONCLUSIONS	Six months chronic aerobic exercise alone or combined with diet result in a significant increase in circulating and adipose tissue adiponectin levels in obese women independent of changes in body composition and/or in HOMA-IR .

###25944453
OBJECTIVE	Infantile spasms ( IS ) are a severe form of childhood epilepsy associated with autism spectrum disorders ( ASD ) in up to 35 % of cases .
OBJECTIVE	The objective of this post hoc analysis of our randomized control trial was to determine whether rapid diagnosis and treatment of IS could limit the incidence of ASD while identifying risk factors related to ASD outcome .
METHODS	Patients with IS were randomized in a standardized diagnostic and treatment protocol .
METHODS	Clinical and electroencephalogram ( EEG ) evaluations were completed at all eight visits over 5 years , while cognitive evaluations were administered at 0 , 6 , 24 and 60 months , respectively .
METHODS	Autism was initially screened by means of the Checklist for Autism in Toddlers ( CHAT ) at 24 months , and formally assessed at the 30-and 60-month follow-ups using the Autism Diagnostic Observation Schedule-Generic ( ADOS-G ) .
RESULTS	Of the 69 patients included in the study , 25 could not be assessed due to severe delay or death .
RESULTS	Eleven of the 42 patients screened with CHAT , were found to be at risk of an ASD outcome .
RESULTS	ADOS was performed in 44 and 10 were diagnosed with ASD .
RESULTS	The CHAT proved to correlate highly with the ADOS ( 80 % ppv ) .
RESULTS	Only patients with symptomatic IS developed ASD ( p = 0.003 ) .
RESULTS	Earlier diagnosis or successful treatment did not correlate with a reduced rate of ASD .
RESULTS	Other risk factors were identified such as having chronic epileptic discharges in the frontotemporal areas after disappearance of hypsarrhythmia ( p = 0.005 and p = 0.007 ) and being of nonwhite origin ( p = 0.009 ) .
CONCLUSIONS	ASD was only observed in children with sympyomatic IS .
CONCLUSIONS	Other clinical risk factors include chronic frontotemporal epileptic activity and being of non-white origin .
CONCLUSIONS	Early diagnosis and treatment did not prevent ASD as an outcome of IS .
CONCLUSIONS	However , patients at risk for ASD could be identified early on and should in the future benefit from early intervention to potentially improve their long-term outcome .

###24515980
OBJECTIVE	Examine a protective crumple zone effect of paranasal sinuses and nasal cavity on skull base fractures .
METHODS	Randomized-control , cadaveric study .
METHODS	In the experimental group ( n = 4 ) , the nasal cavity and bilateral sinuses of cadavers were obliterated with bone cement , whereas the control group ( n = 4 ) had native sinus architecture .
METHODS	Increasing frontal , glabellar impacts were introduced .
METHODS	Each impact event was examined with a high-speed video camera and sphenoid sinus pressure sensor .
METHODS	After each impact , computed tomography scans were performed and fracture sites were analyzed .
RESULTS	The control group with intact sinuses showed statistically longer time duration , during which kinetic energy transfer occurred , and longer sphenoid wall pressure equilibrium time after an impact ( P < 0.05 ) .
RESULTS	In the experimental group , there were statistically higher fracture incidences of clivus , petrous portion of internal carotid , occipital bone , and foramen magnum ( P < 0.05 ) .
RESULTS	The type A pattern ( n = 6 ) had anterior skull base failure occurring before posterior skull base failure .
RESULTS	Type B pattern ( n = 2 ) , seen only in two experimental specimens , is marked by premature posterior skull base collapse occurring before anterior skull base failure with grossly disrupted posterior cranial fossa structures .
CONCLUSIONS	The presence of nasal cavity and paranasal sinuses behaves as a crumple zone to protect the cranial structures , preferentially posterior cranial fossa .
CONCLUSIONS	Obliteration of the nasal cavity and paranasal sinuses with bone cement significantly increased structural tolerance of the anterior cranial vault to frontal , glabellar impacts at the cost of premature , posterior cranial fossa failure .

###24770625
BACKGROUND	The orexin-hypocretin system is important for translating peripheral metabolic signals and central neuronal inputs to a diverse range of behaviors , from feeding , motivation and arousal , to sleep and wakefulness .
BACKGROUND	Orexin signaling is thus an exciting potential therapeutic target for disorders of sleep , feeding , addiction , and stress .
OBJECTIVE	Here , we investigated the low dose pharmacology of orexin receptor antagonist , SB-649868 , on neuroendocrine , sympathetic nervous system , and behavioral responses to insulin-induced hypoglycemic stress , in 24 healthy male subjects ( aged 18-45 years ; BMI 19.0-25 .9 kg/m ( 2 ) ) , using a randomized , double-blind , placebo-controlled , within-subject crossover design .
OBJECTIVE	Alprazolam , a licensed benzodiazepine anxiolytic , was used as a positive comparator , as it has previously been validated using the insulin tolerance test ( ITT ) model in humans .
RESULTS	Of the primary endpoints , ITT induced defined increases in pulse rate , plasma cortisol , and adrenocorticotropic hormone in the placebo condition , but these responses were not significantly impacted by alprazolam or SB-649868 pre-treatment .
RESULTS	Of the secondary endpoints , ITT induced a defined increase in plasma concentrations of adrenaline , noradrenaline , growth hormone ( GH ) , and prolactin in the placebo condition .
RESULTS	Alprazolam pre-treatment significantly reduced the GH response to ITT ( p < 0.003 ) , the peak electromyography ( p < 0.0001 ) and galvanic skin response ( GSR , p = 0.04 ) to acoustic startle , the resting GSR ( p = 0.01 ) , and increased appetite following ITT ( p < 0.0005 ) .
RESULTS	SB-649868 pre-treatment produced no significant results .
CONCLUSIONS	We concluded that the ITT model may be informative for assessing the effects of drugs directly acting on the neuroendocrine or sympathetic nervous systems , but could not be validated for studying low dose orexin antagonist activity .

###24867917
OBJECTIVE	The purpose of the current study was to pilot-test a positive psychology intervention to improve adherence to diabetes management in adolescents with type 1 diabetes .
METHODS	A total of 39 adolescents ( ages , 13-17 years ) with type 1 diabetes and their caregivers were randomized to a positive psychology intervention ( n = 20 ) or an attention control ( education ) intervention ( n = 19 ) .
METHODS	The intervention condition used positive psychology exercises ( eg , gratitude , self-affirmation ) , small gifts , and parent affirmations to boost positive affect .
METHODS	Outcomes included frequency of blood glucose monitoring , quality of life , and glycemic control .
RESULTS	No main effects for treatment were observed at the 6-month follow-up .
RESULTS	However , there was a significant association between adolescents ' levels of positive affect and measures of adherence , including self-report and meter downloads of glucose monitoring .
CONCLUSIONS	The results from the current study support the assertion that positive affect in the context of diabetes education is an important factor to consider in adolescents with type 1 diabetes .

###25711319
OBJECTIVE	The aim of this report is to describe the challenges , successes and patterns of enrolment in the Strategic Timing of AntiRetroviral Treatment ( START ) study .
METHODS	START is a collaboration of many partners with central coordination provided by the protocol team , the statistical and data management centre ( SDMC ) , the International Network for Strategic Initiatives in Global HIV Trials ( INSIGHT ) network leadership , international coordinating centres and site coordinating centres .
METHODS	The SDMC prepared reports on study accrual , baseline characteristics and site performance that allowed monitoring of enrolment and data quality and helped to ensure the successful enrolment of this large international trial .
METHODS	We describe the pattern of enrolment and challenges faced during the enrolment period of the trial .
RESULTS	An initial pilot phase began in April 2009 and established feasibility of accrual at 101 sites .
RESULTS	In August 2010 , funding approval for an expanded definitive phase led to the successful accrual of 4688 participants from 215 sites in 35 countries by December 2013 .
RESULTS	Challenges to accrual included regulatory delays ( e.g. national/local ethics approval and drug importation approval ) and logistical obstacles ( e.g. execution of contracts with pharmaceutical companies , setting up of a central drug repository and translation of participant materials ) .
RESULTS	The personal engagement of investigators , strong central study coordination , and frequent and transparent communication with site investigators , community members and participants were key contributing factors to this success .
CONCLUSIONS	Accrual into START was completed in a timely fashion despite multiple challenges .
CONCLUSIONS	This success was attributable to the efforts of site investigators committed to maintaining study equipoise , transparent and responsive study coordination , and community involvement in problem-solving .

###24712840
OBJECTIVE	An emerging body of evidence supports a role for dysfunctional purinergic neurotransmission in mood disorders .
OBJECTIVE	Adenosine agonists have been shown to have properties similar to those of dopamine antagonists ; there is a well-characterized interaction between adenosine and dopamine receptors in the ventral striatum , and increasing adenosinergic transmission has been demonstrated to reduce the affinity of dopamine agonists for dopamine receptors .
OBJECTIVE	Allopurinol increases adenosine levels in the brain , and hence is hypothesized to reduce the symptoms of mania .
OBJECTIVE	Two randomized , placebo-controlled trials administering add-on allopurinol to manic patients showed significantly greater improvements in Young Mania Rating Scale ( YMRS ) scores for drug compared to placebo , while a more recent , relatively small , add-on study showed negative results .
OBJECTIVE	Based on these data , our objective was to examine the efficacy of allopurinol as add-on treatment to mood stabilizers and/or antipsychotic agents in manic patients with bipolar disorder .
METHODS	We performed a large , well-powered , multicenter , six-week , randomized , placebo-controlled trial of allopurinol added to mood stabilizers and/or antipsychotic agents in 180 patients with bipolar disorder in an acute manic episode .
RESULTS	Both groups showed improvement on the YMRS ( effect size of 1.5 for placebo and 1.6 for allopurinol ) , with no difference observed between groups on YMRS scores ( t = 0.28 , p = 0.78 ) .
RESULTS	There was no difference in the proportion of patients who responded to treatment ( defined as showing at least 50 % improvement in YMRS score ) between the two groups ( p = 0.92 ) , or in dropout rates ( p = 0.84 ) .
CONCLUSIONS	None of our patients received lithium .
CONCLUSIONS	However , the side effects of lithium and its narrow therapeutic index made the use of lithium less common and , therefore , our study results reflect common current clinical practice .
CONCLUSIONS	In the present study , we used a variety of antipsychotic and/or mood stabilizing treatments , to which we added allopurinol ; one might hypothesize that add-on allopurinol has a different effect in combination with different antipsychotic agents or mood stabilizers .
CONCLUSIONS	The findings of this large , well-powered study do not support add-on allopurinol as a treatment for acute mania .
CONCLUSIONS	This study did not test the efficacy of allopurinol as monotherapy .

###24852515
OBJECTIVE	The objective was to investigate the potential protective effects of two conditioning methods , on myocardial ischemic and reperfusion injury in relation to cardiac surgery .
METHODS	Totally 68 patients were randomly assigned to either a control group ( n = 23 ) , a remote ischemic preconditioning ( RIPC ) group ( n = 23 ) or a glucagon-like peptide-1 ( GLP-1 ) analogue group ( n = 22 ) .
METHODS	The RIPC protocol consisted of three cycles of upper limb ischemia .
METHODS	The GLP-1 analogue protocol consisted of intravenous infusion with exenatide .
METHODS	The primary endpoint was postoperative cardiac enzyme release .
METHODS	The other secondary endpoints were metabolic parameters related to myocardial ischemia , measured using microdialysis technique , as well as other operative - and postoperative data .
RESULTS	Postoperative cardiac enzyme release indicated a possible beneficial effect of the interventions , but the difference did not reach statistical significance .
RESULTS	RIPC showed a trend toward lower levels ( p = 0.07 ) .
RESULTS	We managed to establish a functional myocardial microdialysis model , but we were unable to demonstrate clear protective effects .
CONCLUSIONS	We were in this prospective randomized proof-of-concept trial , unable to show distinct protective effects of the studied conditioning methods .
CONCLUSIONS	However , this trial can hopefully contribute to generate a productive discussion concerning limitations and future use of cardiac conditioning as well as microdialysis technique .

###24977638
BACKGROUND	Laparoscopic cholecystectomy performed during low intraabdominal pressure ( < 12 mm Hg ) is associated with significantly less postoperative pain than standard pressure ( 12 mm Hg ) .
BACKGROUND	The impact on surgical space conditions and safety of operating at lower pressures has not been adequately described , but deep neuromuscular blockade may be beneficial .
BACKGROUND	We investigated if deep muscle relaxation would be associated with a higher proportion of procedures with `` optimal '' surgical space conditions compared with moderate relaxation during low-pressure ( 8 mm Hg ) laparoscopic cholecystectomy .
METHODS	In this assessor-blinded study , 48 patients undergoing elective laparoscopic cholecystectomy were administered rocuronium for neuromuscular blockade and randomized to either deep neuromuscular blockade ( rocuronium bolus plus infusion maintaining a posttetanic count 0-1 ) or moderate neuromuscular blockade ( rocuronium repeat bolus only for inadequate surgical conditions with spontaneous recovery of neuromuscular function ) .
METHODS	Patients received anesthesia with propofol , remifentanil , and rocuronium .
METHODS	The primary outcome was the proportion of procedures with optimal surgical space conditions ( assessed by the surgeon as 1 on a 4-point scale ) .
METHODS	Secondary outcomes included the proportion of procedures completed at pneumoperitoneum 8 mm Hg and surgical space conditions on dissection of the gallbladder ( numeric rating scale 0-100 ; 0 = optimal surgical space conditions ; 100 = unacceptable surgical space conditions ) .
RESULTS	Optimal surgical space conditions during the entire procedure were observed in 7 of 25 patients allocated to deep neuromuscular blockade and in 1 of 23 patients allocated to moderate blockade ( P = 0.05 ) with an absolute difference of 24 % between the groups ( 95 % confidence interval , 4 % -43 % ) .
RESULTS	Laparoscopic cholecystectomy was completed at pneumoperitoneum 8 mm Hg in 15 of 25 and 8 of 23 patients in the deep and moderate group , respectively ( 95 % confidence interval , -2 % to 53 % ; P = 0.08 ) .
RESULTS	Surgical space conditions during dissection of the gallbladder assessed by use of the numeric rating scale were 20 ( 10-50 ) ( median [ 25 % -75 % range ] ) in the deep neuromuscular blockade group and 30 ( 10-50 ) in the moderate group ( P = 0.58 ; Wilcoxon-Mann-Whitney odds , 1.2 ; 95 % confidence interval , 0.6-2 .5 ) .
RESULTS	No operations were converted to laparotomy .
CONCLUSIONS	Deep neuromuscular blockade was associated with surgical space conditions that were marginally better than with moderate muscle relaxation during low-pressure laparoscopic cholecystectomy .

###25294665
OBJECTIVE	This study aimed to ascertain whether training-induced muscle hypertrophy is accompanied by an increase in the aponeurosis width , and to infer its impact on the training-induced increase in the pennation angle .
METHODS	Eleven young men completed a resistance training program of unilateral knee extensions for 12 weeks .
METHODS	Before and after training , anatomical cross-sectional area ( ACSA ) of the vastus lateralis and its distal aponeurosis width in the transverse plane were measured with magnetic resonance imaging .
METHODS	The pennation angle and fascicle length were also determined with ultrasonography at the midbelly of the muscle .
METHODS	The effect of change in aponeurosis width on the magnitude of training-induced increase in pennation angle was estimated by using a parallelepipedon model .
RESULTS	After the training , there were significant increases in ACSA ( 10.7 7.6 % ) , pennation angle ( 10.8 7.3 % ) and aponeurosis width ( 1.9 3.1 % ) , whereas no significant change was found in the fascicle length .
RESULTS	The model simulation shows that the increase in aponeurosis width by 1.9 % reduces the magnitude of increase in pennation angle by only 0.4 .
CONCLUSIONS	These results indicate that ( 1 ) the aponeurosis width of the vastus lateralis increases after 12 weeks of resistance training and ( 2 ) the increase in the aponeurosis width accompanying muscle hypertrophy by the amount of ~ 10 % does not substantially affect the increase in pennation angle .

###25498067
BACKGROUND	Physical rehabilitation programs for kidney transplant recipients are not routinely personalized to patients ' physical and emotional health , which could result in a potentially limited health impact , shorter-term participation , and an overall low success rate .
METHODS	We conducted an internal review board-approved randomized prospective study involving a 12-month supervised multidisciplinary rehabilitation program ( GH method ) initiated after kidney transplantation in obese recipients ( body mass index > 30 ) .
METHODS	The new method incorporates 3 major components : physical exercise , behavioral interventions , and nutritional guidance .
METHODS	We compared 9 patients who underwent supervised rehabilitation with 8 patients who underwent standard care .
METHODS	Patients were followed up after the start of the intervention , and multiple assessments were performed .
RESULTS	The adherence to training and follow-up was 100 % in the intervention group , compared with 25 % at 12 months in the control group .
RESULTS	There was a trend for a higher glomerular filtration rate in the intervention group compared with the control group ( 55.5 18.6 mL/min/1 .73 m ( 2 ) vs 38.8 18.9 mL/min/1 .73 m ( 2 ) , P = .06 ) .
RESULTS	The quality of life ( SF-36 ) mean score improved more in the intervention group compared with the control group ( 583 13 vs 436 22 , P = .008 ) .
RESULTS	There was a significantly higher employment rate in the intervention group , 77.7 % at 12 months compared with 12.5 % in the control group ( P = .02 ) .
CONCLUSIONS	Our preliminary results suggest that this comprehensive approach to physical rehabilitation can improve adherence , kidney function , quality of life , and employment rate for obese patients after kidney transplantation .

###24596456
BACKGROUND	In cystic fibrosis ( CF ) , the paranasal sinuses are sites of first and persistent colonization by pathogens such as Pseudomonas aeruginosa .
BACKGROUND	Pathogens subsequently descend to the lower airways , with P. aeruginosa remaining the primary cause of premature death in patients with the inherited disease .
BACKGROUND	Unlike conventional aerosols , vibrating aerosols applied with the PARI Sinus nebulizer deposit drugs into the paranasal sinuses .
BACKGROUND	This trial assessed the effects of vibrating sinonasal inhalation of the antibiotic tobramycin in CF patients positive for P. aeruginosa in nasal lavage .
OBJECTIVE	To evaluate the effects of sinonasal inhalation of tobramycin on P. aeruginosa quantification in nasal lavage ; and on patient quality of life , measured with the Sino-Nasal Outcome Test ( SNOT-20 ) , and otologic and renal safety and tolerability .
METHODS	Patients were randomized to inhalation of tobramycin ( 80 mg/2 mL ) or placebo ( 2 mL isotonic saline ) once daily ( 4 minutes/nostril ) with the PARI Sinus nebulizer over 28 days , with all patients eligible for a subsequent course of open-label inhalation of tobramycin for 28 days .
METHODS	Nasal lavage was obtained before starting and 2 days after the end of each treatment period by rinsing each nostril with 10 mL of isotonic saline .
RESULTS	Nine patients participated , six initially receiving tobramycin and three placebo .
RESULTS	Sinonasal inhalation was well tolerated , with serum tobramycin < 0.5 mg/L and stable creatinine .
RESULTS	P. aeruginosa quantity decreased in four of six ( 67 % ) patients given tobramycin , compared with zero of three given placebo ( non-significant ) .
RESULTS	SNOT-20 scores were significantly lower in the tobramycin than in the placebo group ( P = 0.033 ) .
CONCLUSIONS	Sinonasal inhalation of vibrating antibiotic aerosols appears promising for reducing pathogen colonization of paranasal sinuses and for control of symptoms in patients with CF.

###25011352
OBJECTIVE	The orodispersible house dust mite ( HDM ) sublingual immunotherapy ( SLIT ) - tablet ( ALK , Denmark ) is being developed for the treatment of HDM respiratory allergic disease .
OBJECTIVE	The objective of the 2 phase I trials was to investigate tolerability and the acceptable dose range of HDM SLIT-tablet treatment in adults and children with HDM respiratory allergic disease .
METHODS	The trials were randomized , multiple-dose , dose-escalation , double-blind , placebo-controlled phase I trials including patients with HDM-induced asthma , with or without rhinoconjunctivitis .
METHODS	Both trials were registered in EudraCT ( Trial 1 : 2005-002151-41 ; Trial 2 : 2007-000402-67 ) .
METHODS	Trial 1 included 71 adults ( 18-63 years ) and trial 2 included 72 children ( 5-14 years ) .
METHODS	Both trials included 6 dose groups that were randomized 3:1 to active treatment or placebo once daily for 28 days .
METHODS	Adverse events ( AEs ) were coded in MedDRA ( version 8.1 or later ) .
METHODS	Immunological variables included specific IgE and IgE-blocking factor .
RESULTS	No serious AEs were reported .
RESULTS	In trial 1 ( maximum dose , 32 development units [ DU ] ) , 1 patient in the 16 DU group discontinued due to AEs .
RESULTS	The entire 32 DU group was discontinued as 1 patient had a severe adverse reaction .
RESULTS	In trial 2 ( maximum dose , 12 DU ) , no patients discontinued prematurely .
RESULTS	The most frequently reported AEs were mild application-site related events .
RESULTS	The total number of events was dose-related within each trial .
RESULTS	HDM SLIT-tablet treatment induced changes in immunological parameters in a dose-dependent manner .
CONCLUSIONS	These trials demonstrate that doses up to 12 DU of HDM SLIT-tablet were tolerated in the selected populations , and thus are suitable for further clinical investigations in adults and children with HDM respiratory allergic disease .

###25356046
OBJECTIVE	To investigate the feasibility and safety of pH capsule to monitor pH in patients with gastroesophageal reflux disease ( GERD ) .
METHODS	Ninety-one patients with symptoms suggestive of GERD were enrolled in this study , 46 of whom were randomized to the pH capsule group ; the remaining 45 patients used the conventional catheter and pH capsule simultaneously .
METHODS	The pH data and traces were recorded via automatic analysis , and capsule detachment was assessed using X-ray images .
METHODS	All of the patients were required to complete a questionnaire regarding tolerance with the capsule .
RESULTS	The capsules were successfully attached on the first attempt , and no early detachment of the capsules was observed .
RESULTS	Compared to the 24-h pH data recorded with the conventional catheter , the data collected with the pH capsule showed no significant differences in 24-h esophageal acid exposure .
RESULTS	The measurements of esophageal acid exposure over 24 h collected with the two devices showed a significant correlation ( r ( 2 ) = 0.996 , P < 0.001 ) .
RESULTS	Capsule detachment occurred spontaneously in 89 patients , and 2 capsules required endoscopic removal due to chest pain .
RESULTS	The capsule was associated with less interference with daily activity .
CONCLUSIONS	The wireless pH capsule provides a feasible and safe method for monitoring gastroesophageal reflux and therefore may serve as an important tool for diagnosing GERD .

###25442691
BACKGROUND	Male circumcision is a primary HIV-1 prevention intervention for men , but whether the procedure reduces the risk of syphilis among men and their female partners is uncertain .
BACKGROUND	We aimed to assess whether male circumcision was associated with incident syphilis in men and in their female partners .
METHODS	In this large prospective cohort study , participants were members of Kenyan and Ugandan HIV-1 serodiscordant heterosexual couples enrolled in a randomised safety and efficacy clinical trial of pre-exposure prophylaxis for HIV-1 prevention ( the Partners PrEP Study ) .
METHODS	Participants attended monthly or quarterly follow-up visits for up to 36 months .
METHODS	Annually , syphilis serology testing was done and male circumcision status was assessed .
METHODS	We used multivariate Andersen-Gill survival methods , adjusted for age , sexual behaviour , and plasma HIV RNA levels of the HIV-infected partner .
RESULTS	4716 HIV-1 serodiscordant couples ( 38 % ) with a man with HIV were followed for a median of 275 years .
RESULTS	At enrolment , 1575 ( 53 % ) men with HIV and 560 ( 32 % ) men without HIV were circumcised ; an additional 69 ( 4 % ) men with HIV and 132 ( 5 % ) men without HIV were circumcised during study follow-up .
RESULTS	221 incident syphilis infections were reported : 46 ( 21 % ) in men with HIV ( incidence 110 per 100 person-years ) , 76 ( 34 % ) in men without HIV ( 109 ) , 54 ( 24 % ) in women with HIV ( 077 ) , and 45 ( 24 % ) in women without HIV ( 111 ) .
RESULTS	Male circumcision was associated with a 42 % reduction in incident syphilis in men ( adjusted hazard ratio [ aHR ] 058 , 95 % CI 037-091 ) including a 62 % reduction in men with HIV ( 038 , 018-081 ) , and a non-significant reduction in incident syphilis in men without HIV ( 064 , 036-111 ) .
RESULTS	In women , circumcision of their male partners was associated with a 59 % reduction in incident syphilis ( aHR 041 , 95 % CI 025-069 ) , including a 75 % reduction in women without HIV ( 025 , 008-076 ) and a 48 % reduction in women with HIV ( 052 , 027-097 ) .
CONCLUSIONS	Male circumcision was associated with decreased risk of incident syphilis in men and women .
CONCLUSIONS	If confirmed , these results suggest that medical male circumcision could substantially reduce incidence of syphilis and its sequelae .
BACKGROUND	Bill & Melinda Gates Foundation and the Eunice Kennedy Shriver National Institute of Child Health and Human Development .

###24231251
BACKGROUND	Telomere length in blood or buccal cell DNA has been associated with risk of various cancers .
BACKGROUND	Glioma can be a highly malignant brain tumor and has few known risk factors .
BACKGROUND	Genetic variants in or near RTEL1 and TERT , key components of telomere biology , are associated with glioma risk .
BACKGROUND	Therefore , we evaluated the association between relative telomere length ( RTL ) and glioma in a prospective study .
METHODS	We performed a nested case-control study within the Prostate , Lung , Colorectal , and Ovarian ( PLCO ) Cancer Screening Trial .
METHODS	RTL was determined by quantitative PCR on blood or buccal cell DNA obtained at least 2 years prior to diagnosis from 101 individuals with glioma cases .
METHODS	Healthy controls ( n = 198 ) were matched to cases ( 2:1 ) on age , gender , smoking status , calendar year , and DNA source .
METHODS	Conditional logistic regression was used to investigate the association between RTL and glioma .
RESULTS	As expected , RTL declined with increasing age in both cases and controls .
RESULTS	There was no statistically significant association between RTL and glioma overall .
RESULTS	An analysis stratified by gender suggested that short RTL ( 1st tertile ) in males was associated with glioma ( odds ratio , [ OR ] = 2.29 , 95 % confidence interval [ CI ] 1.02-5 .11 ) ; this association was not observed for females ( OR = 0.41 , 95 % CI 0.14-1 .17 ) .
CONCLUSIONS	This prospective study did not identify significant associations between RTL and glioma risk , but there may be gender-specific differences .
CONCLUSIONS	Larger , prospective studies are needed to evaluate these findings .

###24777019
OBJECTIVE	The philtral column and dimple are especially important in patients with cleft lip .
OBJECTIVE	Recently , we have found that , at maximal puckering , the appearance of the philtrum worsens although the philtral column is well formed at rest .
OBJECTIVE	In this study , we explore the effectiveness of the coronal muscle splitting technique in a microform cleft lip through comparative analysis of the postoperative results between the control group ( patients without coronal muscle splitting ) and the study group ( patients with coronal muscle splitting ) .
METHODS	Philtral reconstruction was performed in 24 patients with microform cleft lip between March 2006 and March 2010 .
METHODS	The philtrum was reconstructed in 12 patients using the coronal muscle splitting technique and in the other 12 patients without this technique .
METHODS	The convexity of the philtral column and the dimpling of the philtrum were evaluated at rest and at maximal puckering through digital photographs and videos taken preoperatively and postoperatively .
METHODS	In addition , we compared the postoperative results between the 2 groups using the paired t-test .
RESULTS	Postoperative evaluation was done at 6 to 48 months ( mean , 25 mo ) .
RESULTS	There was no statistically significant difference in the shape of the philtral column and the philtral dimple between the 2 groups preoperatively ( P > 0.05 ) .
RESULTS	Reconstruction of the philtral column in the study group rendered better results than in the control group at both rest and maximal puckering ( P < 0.001 and P < 0.001 ) .
RESULTS	Reconstruction of the philtral dimple in the study group rendered better results than in the control group at both rest and maximal puckering ( P = 0.018 and 0.035 ) .
CONCLUSIONS	The coronal muscle splitting technique offers more esthetic and functional results in the formation of the philtral column and dimple both at rest and at maximal puckering than in the control group in cases of philtral reconstruction of the microform cleft lip .

###24909528
OBJECTIVE	The construct of ` preparation for future learning ' ( PFL ) is understood as the ability to learn new information from available resources , relate new learning to past experiences and demonstrate innovation and flexibility in problem solving .
OBJECTIVE	Preparation for future learning has been proposed as a key competence of adaptive expertise .
OBJECTIVE	There is a need for educators to ensure that opportunities are provided for students to develop PFL ability and that assessments accurately measure the development of this form of competence .
OBJECTIVE	The objective of this research was to compare the relative impacts of basic science instruction and clinically focused instruction on performance on a PFL assessment ( PFLA ) .
METHODS	This study employed a ` double transfer ' design .
METHODS	Fifty-one pre-clerkship students were randomly assigned to either basic science instruction or clinically focused instruction to learn four categories of disease .
METHODS	After completing an initial assessment on the learned material , all participants received clinically focused instruction for four novel diseases and completed a PFLA .
METHODS	The data from the initial assessment and the PFLA were submitted to independent-sample t-tests .
RESULTS	Meanstandard deviation [ SD ] scores on the diagnostic cases in the initial assessment were similar for participants in the basic science ( 0.650.11 ) and clinical learning ( 0.620.11 ) conditions .
RESULTS	The difference was not significant ( t [ 42 ] = 0.90 , p = 0.37 , d = 0.27 ) .
RESULTS	Analysis of the diagnostic cases on the PFLA revealed significantly higher meanSD scores for participants in the basic science learning condition ( 0.720.14 ) compared with those in the clinical learning condition ( 0.630.15 ) ( t [ 42 ] = 2.02 , p = 0.05 , d = 0.62 ) .
CONCLUSIONS	Our results show that the inclusion of basic science instruction enhanced the learning of novel related content .
CONCLUSIONS	We discuss this finding within the broader context of research on basic science instruction , development of adaptive expertise and assessment in medical education .

###25297989
OBJECTIVE	This study assessed whether a cycle of `` routine '' therapeutic drug monitoring ( TDM ) for imatinib dosage individualization , targeting an imatinib trough plasma concentration ( C min ) of 1,000 ng/ml ( tolerance : 750-1 ,500 ng/ml ) , could improve clinical outcomes in chronic myelogenous leukemia ( CML ) patients , compared with TDM use only in case of problems ( `` rescue '' TDM ) .
METHODS	Imatinib concentration monitoring evaluation was a multicenter randomized controlled trial including adult patients in chronic or accelerated phase CML receiving imatinib since less than 5years .
METHODS	Patients were allocated 1:1 to `` routine TDM '' or `` rescue TDM . ''
METHODS	The primary endpoint was a combined outcome ( failure - and toxicity-free survival with continuation on imatinib ) over 1-year follow-up , analyzed in intention-to-treat ( ISRCTN31181395 ) .
RESULTS	Among 56 patients ( 55 evaluable ) , 14/27 ( 52 % ) receiving `` routine TDM '' remained event-free versus 16/28 ( 57 % ) `` rescue TDM '' controls ( P = 0.69 ) .
RESULTS	In the `` routine TDM '' arm , dosage recommendations were correctly adopted in 14 patients ( median C min : 895ng/ml ) , who had fewer unfavorable events ( 28 % ) than the 13 not receiving the advised dosage ( 77 % ; P = 0.03 ; median C min : 648ng/ml ) .
CONCLUSIONS	This first target concentration intervention trial could not formally demonstrate a benefit of `` routine TDM '' because of small patient number and surprisingly limited prescriber 's adherence to dosage recommendations .
CONCLUSIONS	Favorable outcomes were , however , found in patients actually elected for target dosing .
CONCLUSIONS	This study thus shows first prospective indication for TDM being a useful tool to guide drug dosage and shift decisions .
CONCLUSIONS	The study design and analysis provide an interesting paradigm for future randomized TDM trials on targeted anticancer agents .

###24650849
BACKGROUND	Computed tomography ( CT ) scans of the lumbar spine ( CTLS ) have demonstrated a higher level of accuracy than plain films and have been used to assess patients with spinal disorder when magnetic resonance imaging is not available .
BACKGROUND	Nevertheless , radiation exposure remains a serious safety concern .
BACKGROUND	Iterative reconstruction ( IR ) decreases the CT radiation dose for diagnostic imaging .
BACKGROUND	However , the feasibility of using IR in CTLS is unclear .
OBJECTIVE	To evaluate the imaging quality and diagnostic reliability of CTLS with IR .
METHODS	A prospective study .
METHODS	All patients from outpatient departments who suffered from spinal disorders and were referred for CTLS .
METHODS	In acquired CT images , the signal-to-noise ratio ( SNR ) of the dural sac ( DS ) , intervertebral disc ( IVD ) , psoas muscle ( PM ) , and L5 vertebral body , the contrast-to-noise ratio between the DS and IVD ( D-D CNR ) , and the subjective imaging qualities were compared across groups .
METHODS	Interobserver agreement was evaluated with kappa values .
METHODS	Patients receiving low radiation CTLS were divided into three groups .
METHODS	A 150 mAs tube current with 120 kVp tube voltage was used with Group A and a 230 mAs tube current with 100 kVp tube voltage with Group B. Intended end radiation exposure was 50 % less than that of the control group .
METHODS	Tube modulation was active for all groups .
METHODS	The images of the two low-radiation groups were reconstructed by IR ; those of the control group by filtered back-projection ( FBP ) .
RESULTS	The SNRs of the DS , IVD , PM , BM , and D-D CNR of Group A were not inferior to those of the control group .
RESULTS	All SNRs and D-D CNRs for Group B were inferior to those of the control group .
RESULTS	Except for that of the facet joint , all subjective imaging ratings for anatomic regions were equivalent between Groups A and B. Interobserver agreement was highest for the control group ( 0.72-0 .88 ) , followed by Group A ( 0.69-0 .83 ) and B ( 0.55-0 .83 ) .
CONCLUSIONS	Fifty percent tube current reduction combined with IR provides equivalent diagnostic accuracy and improved patient safety when compared with conventional CTLS .
CONCLUSIONS	Our results support its use as a screening tool .
CONCLUSIONS	With the tube modulation technique , further adjustments in weighting IR and FBP algorithms based on body mass index become unnecessary .

###24578470
BACKGROUND	The clinical benefits of using icodextrin during acute peritonitis in peritoneal dialysis are uncertain .
BACKGROUND	On the premise that high glucose concentration might jeopardize the peritoneal defense during peritonitis , icodextrin administration during acute peritonitis could have the potential to improve the peritonitis outcome whilst improving ultrafiltration .
METHODS	We conducted a single-center , open-label , randomized controlled trial in which 53 adult continuous ambulatory peritoneal dialysis patients underwent randomization to receive either icodextrin or original glucose-based dialysis solution .
METHODS	The primary outcome measure was the peritoneal dialyzate white cell count on Day 3 .
METHODS	Secondary outcome measures comprised the need of additional hypertonic exchanges , fluid control as denoted by changes in body weight , and the clinical outcome of peritonitis including 30-day and 120-day all-cause mortality .
RESULTS	Between icodextrin and control treatment groups , there were no statistically significant differences in the peritoneal dialyzate white cell count on day ( 1829 versus 987/mm ( 3 ) , P = 0.13 ) .
RESULTS	There was neither improvement in primary cure rate ( 31.8 versus 32.3 % , P = 1.00 ) , nor was there any change in 120-day mortality after icodextrin use ( 13.6 versus 12.9 % , P = 1.00 ) .
RESULTS	However , requirement of hypertonic dialysis exchange was much more frequent in the control group than in those randomized to icodextrin ( 35.5 versus 0 % , P = 0.001 ) .
RESULTS	Body weight did not change significantly in the icodextrin group , but body weight in the control group increased from 63.3 14.5 kg at baseline to 64.2 14.2 kg at Day 5 ( P = 0.0002 ) and 65.2 14.1 kg at Day 10 ( P < 0.0001 ) .
CONCLUSIONS	As compared with glucose-based peritoneal dialysis solution , use of icodextrin achieved better ultrafiltration and fluid control during acute peritonitis complicating continuous ambulatory peritoneal dialysis , although we found no evidence of a worthwhile clinical benefit on peritonitis resolution .
CONCLUSIONS	( ClinicalTrial.gov number , NCT0104446 [ ClinicalTrial.gov ] . )

###25456331
BACKGROUND	Maternal risk factors for fetal alcohol spectrum disorders ( FASD ) in Italy and Mediterranean cultures need clarification , as there are few studies and most are plagued by inaccurate reporting of antenatal alcohol use .
METHODS	Maternal interviews ( n = 905 ) were carried out in a population-based study of the prevalence and characteristics of FASD in the Lazio region of Italy which provided data for multivariate case control comparisons and multiple correlation models .
RESULTS	Case control findings from interviews seven years post-partum indicate that mothers of children with FASD are significantly more likely than randomly-selected controls or community mothers to : be shorter ; have higher body mass indexes ( BMI ) ; be married to a man with legal problems ; report more drinking three months pre-pregnancy ; engage in more current drinking and drinking alone ; and have alcohol problems in her family .
RESULTS	Logistic regression analysis of multiple candidate predictors of a FASD diagnosis indicates that alcohol problems in the child 's family is the most significant risk factor , making a diagnosis within the continuum of FASD 9 times more likely ( 95 % C.I. = 1.6 to 50.7 ) .
RESULTS	Sequential multiple regression analysis of the child 's neuropsychological performance also identifies alcohol problems in the child 's family as the only significant maternal risk variable ( p < .001 ) when controlling for other potential risk factors .
CONCLUSIONS	Underreporting of prenatal alcohol use has been demonstrated among Italian and other Mediterranean antenatal samples , and it was suspected in this sample .
CONCLUSIONS	Nevertheless , several significant maternal risk factors for FASD have been identified .

###25193531
OBJECTIVE	To compare the efficacy and safety of new insulin glargine 300 units/mL ( Gla-300 ) with glargine 100 units/mL ( Gla-100 ) in people with type 2 diabetes using basal insulin ( 42 units/day ) plus oral antihyperglycemic drugs ( OADs ) .
METHODS	EDITION 2 was a multicenter , open-label , two-arm study .
METHODS	Adults receiving basal insulin plus OADs were randomized to Gla-300 or Gla-100 once daily for 6 months .
METHODS	The primary end point was change in HbA1c .
METHODS	The main secondary end point was percentage of participants with one or more nocturnal confirmed ( 3.9 mmol/L [ 70 mg/dL ] ) or severe hypoglycemic events from week 9 to month 6 .
RESULTS	Randomized participants ( n = 811 ) had a mean ( SD ) HbAc of 8.24 % ( 0.82 ) and BMI of 34.8 kg/m ( 2 ) ( 6.4 ) .
RESULTS	Glycemic control improved similarly with both basal insulins ; least squares mean ( SD ) reduction from baseline was -0.57 % ( 0.09 ) for Gla-300 and -0.56 % ( 0.09 ) for Gla-100 ( mean difference -0.01 % [ 95 % CI -0.14 to 0.12 ] ) , with 10 % higher dose of Gla-300 .
RESULTS	Less nocturnal confirmed ( 3.9 mmol/L [ 70 mg/dL ] ) or severe hypoglycemia was observed with Gla-300 from week 9 to month 6 ( relative risk 0.77 [ 95 % CI 0.61-0 .99 ] ; P = 0.038 ) and during the first 8 weeks .
RESULTS	Fewer nocturnal and any time ( 24 h ) hypoglycemic events were reported during the entire 6-month period .
RESULTS	Weight gain was lower with Gla-300 than with Gla-100 ( P = 0.015 ) .
RESULTS	No between-treatment differences in safety parameters were identified .
CONCLUSIONS	Gla-300 was as effective as Gla-100 and associated with a lower risk of hypoglycemia during the night and at any time of the day .

###25372085
BACKGROUND	The combination of cyclophosphamide and glucocorticoids leads to remission in most patients with antineutrophil cytoplasm antibody ( ANCA ) - associated vasculitides .
BACKGROUND	However , even when patients receive maintenance treatment with azathioprine or methotrexate , the relapse rate remains high .
BACKGROUND	Rituximab may help to maintain remission .
METHODS	Patients with newly diagnosed or relapsing granulomatosis with polyangiitis , microscopic polyangiitis , or renal-limited ANCA-associated vasculitis in complete remission after a cyclophosphamide-glucocorticoid regimen were randomly assigned to receive either 500 mg of rituximab on days 0 and 14 and at months 6 , 12 , and 18 after study entry or daily azathioprine until month 22 .
METHODS	The primary end point at month 28 was the rate of major relapse ( the reappearance of disease activity or worsening , with a Birmingham Vasculitis Activity Score > 0 , and involvement of one or more major organs , disease-related life-threatening events , or both ) .
RESULTS	The 115 enrolled patients ( 87 with granulomatosis with polyangiitis , 23 with microscopic polyangiitis , and 5 with renal-limited ANCA-associated vasculitis ) received azathioprine ( 58 patients ) or rituximab ( 57 patients ) .
RESULTS	At month 28 , major relapse had occurred in 17 patients in the azathioprine group ( 29 % ) and in 3 patients in the rituximab group ( 5 % ) ( hazard ratio for relapse , 6.61 ; 95 % confidence interval , 1.56 to 27.96 ; P = 0.002 ) .
RESULTS	The frequencies of severe adverse events were similar in the two groups .
RESULTS	Twenty-five patients in each group ( P = 0.92 ) had severe adverse events ; there were 44 events in the azathioprine group and 45 in the rituximab group .
RESULTS	Eight patients in the azathioprine group and 11 in the rituximab group had severe infections , and cancer developed in 2 patients in the azathioprine group and 1 in the rituximab group .
RESULTS	Two patients in the azathioprine group died ( 1 from sepsis and 1 from pancreatic cancer ) .
CONCLUSIONS	More patients with ANCA-associated vasculitides had sustained remission at month 28 with rituximab than with azathioprine .
CONCLUSIONS	( Funded by the French Ministry of Health ; MAINRITSAN ClinicalTrials.gov number , NCT00748644 ; EudraCT number , 2008-002846-51 . )

###24326597
BACKGROUND	In the Prevention of Malaria and HIV disease in Tororo pediatrics trial , HIV-infected Ugandan children randomized to receive lopinavir/ritonavir ( LPV/r ) - based antiretroviral therapy ( ART ) experienced a lower incidence of malaria compared with children receiving nonnucleoside reverse transcriptase inhibitor ( NNRTI ) - based ART .
BACKGROUND	Here we present the results of the noninferiority analysis of virologic efficacy and comparison of immunologic outcomes .
METHODS	ART-naive or - experienced ( HIV RNA < 400 copies/mL ) children aged 2 months to 6 years received either LPV/r or NNRTI-based ART .
METHODS	The proportion of children with virologic suppression ( HIV RNA < 400 copies/mL ) at 48 weeks was compared using a prespecified noninferiority margin of -11 % in per-protocol analysis .
METHODS	Time to virologic failure by 96 weeks , change in CD4 counts and percentages , and incidence of adverse event rates were also compared .
RESULTS	Of 185 children enrolled , 91 initiated LPV/r and 92 initiated NNRTI-based ART .
RESULTS	At baseline , the median age was 3.1 years ( range , 0.4-5 .9 ) , and 131 ( 71 % ) children were ART-naive .
RESULTS	The proportion of children with virologic suppression at 48 weeks was 80 % ( 67/84 ) in the LPV/r arm vs. 76 % ( 59/78 ) in the NNRTI arm , a difference of 4 % ( 95 % confidence interval : -9 % to +17 % ) .
RESULTS	Time to virologic failure , CD4 changes , and the incidence of Division of AIDS grade III/IV adverse events were similar between arms .
CONCLUSIONS	LPV/r-based ART was not associated with worse virologic efficacy , immunologic efficacy , or adverse event rates compared with NNRTI-based ART .
CONCLUSIONS	Considering these results and the reduction in malaria incidence associated with LPV/r previously reported for this trial , wider use of LPV/r to treat HIV-infected African children in similar malaria-endemic settings could be considered .

###24674654
BACKGROUND	The impact of the age of first Plasmodium falciparum infection on the rate of acquisition of immunity to malaria and on the immune correlates of protection has proven difficult to elucidate .
BACKGROUND	A randomized , double-blind , placebo-controlled trial using monthly chemoprophylaxis with sulphadoxine-pyrimethamine plus artesunate was conducted to modify the age of first P. falciparum erythrocytic exposure in infancy and assess antibodies and malaria risk over two years .
METHODS	Participants ( n = 349 ) were enrolled at birth to one of three groups : late exposure , early exposure and control group , and were followed up for malaria morbidity and immunological analyses at birth , 2.5 , 5.5 , 10.5 , 15 and 24 months of age .
METHODS	Total IgG , IgG subclasses and IgM responses to MSP-1 ( 19 ) , AMA-1 , and EBA-175 were measured by ELISA , and IgG against variant antigens on the surface of infected erythrocytes by flow cytometry .
METHODS	Factors affecting antibody responses in relation to chemoprophylaxis and malaria incidence were evaluated .
RESULTS	Generally , antibody responses did not vary significantly between exposure groups except for levels of IgM to EBA-175 , and seropositivity of IgG1 and IgG3 to MSP-1 ( 19 ) .
RESULTS	Previous and current malaria infections were strongly associated with increased IgG against MSP-1 ( 19 ) , EBA-175 and AMA-1 ( p < 0.0001 ) .
RESULTS	After adjusting for exposure , only higher levels of anti-EBA-175 IgG were significantly associated with reduced clinical malaria incidence ( IRR 0.67 , p = 0.0178 ) .
CONCLUSIONS	Overall , the age of first P. falciparum infection did not influence the magnitude and breadth of IgG responses , but previous exposure was critical for antibody acquisition .
CONCLUSIONS	IgG responses to EBA-175 were the strongest correlate of protection against clinical malaria .
BACKGROUND	ClinicalTrials.gov : NCT00231452 .

###24890528
BACKGROUND	Worldwide , 200 million adults undergo major noncardiac surgery annually , and 10 million of these patients will have a major vascular complication .
BACKGROUND	Low-dose clonidine and low-dose acetyl-salicylic acid ( ASA ) may prevent major perioperative vascular complications .
BACKGROUND	We therefore initiated the POISE-2 trial to establish the perioperative effects of these 2 interventions .
METHODS	The POISE-2 trial is a 2 2 factorial randomized controlled trial of low-dose ASA vs. placebo and low-dose clonidine vs. placebo in 10,000 patients at risk for a perioperative cardiovascular event who are undergoing noncardiac surgery .
METHODS	Both study drugs are initiated prior to surgery ( goal 2-4 hours ) and are continued after surgery .
METHODS	Patients , health care providers , data collectors , and outcome adjudicators are blinded to treatment allocation .
METHODS	The primary outcome is a composite of mortality and nonfatal myocardial infarction at 30 days after randomization .
RESULTS	To date , the POISE-2 trial has recruited more than 9,000 patients from 135 centers in 23 countries .
RESULTS	Among the first 7,500 patients recruited , patients ' mean age was 68.2 years , 53.4 % were male , 34.0 % had a history of vascular disease , and 38.3 % had diabetes that was treated .
RESULTS	Participants had orthopedic ( 38.1 % ) , general ( 27.0 % ) , urologic or gynecologic ( 17.2 % ) , vascular ( 6.6 % ) , thoracic ( 5.7 % ) , and other ( 5.4 % ) surgery .
CONCLUSIONS	POISE-2 is a large international trial that will rigorously evaluate the effects of low-dose clonidine and ASA in patients having noncardiac surgery .

###25357174
BACKGROUND	Onychomycosis is a therapeutic challenge because of the toxicities of systemic medications .
BACKGROUND	This has led to the investigation of light-based technologies for safe and effective alternative treatment modalities .
OBJECTIVE	The purpose of this study was to determine the safety and efficacy of 4 treatments with a 1,320-nm neodymium : yttrium aluminum garnet ( Nd : YAG ) laser in improving the appearance of onychomycosis .
METHODS	This study was a 24-week , single-center randomized placebo-controlled study .
METHODS	Ten subjects were enrolled with culture-proven , bilateral great toenail onychomycosis .
METHODS	The subjects received 4 treatments with the 1,320-nm Nd : YAG laser to the treatment toenail on Days 1 , 7 , 14 , and 60 .
METHODS	The control toenail received a sham treatment of cryogen cooling only .
METHODS	Mycologic cultures were obtained at 3-month follow-up visits .
RESULTS	Fifty percent of mycologic cultures were negative at the 3-month follow-up after 4 laser treatments .
RESULTS	Toenails had improvement in subungual debris , hypertrophy , and yellowing .
RESULTS	Patient satisfaction was upheld as assessed by the Nail Quality of Life Questionnaire .
CONCLUSIONS	The 1,320-nm Nd : YAG laser may be a safe and effective therapy for improving the appearance of onychomycosis .
CONCLUSIONS	Additional therapy may be necessary to enhance long-term results .
CONCLUSIONS	Further investigation needs to explore the optimal treatment settings and the most effective treatment schedule .

###25199121
BACKGROUND	Spaceflight studies and ground-based analogues of microgravity indicate a weakening of human immunity .
BACKGROUND	Mannan-binding lectin ( MBL ) and H - , L - , and M-ficolin together constitute the lectin pathway and mediate the clearance of pathogens through complement activation .
BACKGROUND	We hypothesized that simulated microgravity may weaken human innate immune functions and studied the impact of 6 head-down tilted bed rest ( HDT ) for 21 d on MBL and ficolin levels .
METHODS	Within a 6-mo period , seven men underwent two periods of HDT .
METHODS	Blood samples were analyzed for MBL , H - , L - , and M-ficolin , mannose-binding lectin-associated protein of 44 kDa ( MAp44 ) , and collectin liver 1 ( CL-L1 ) by time-resolved immunofluorometric assays ( TRIFMA ) .
RESULTS	We observed well-defined individual preintervention levels of MBL and ficolins .
RESULTS	Remarkably similar intraindividual changes occurred for MBL and MBL levels decreased ( mean 282 ng ml ) in the recovery phase .
RESULTS	Conversely , CL-L1 , a protein with MBL-like properties , increased ( mean 102 ng ml ) during the recovery phase .
RESULTS	M-ficolin increased ( mean 79 ng ml ) within the first 2 d of HDT , followed by a decrease ( mean 112 ng ml ) during the recovery phase .
RESULTS	L-ficolin increased ( mean 304 ng ml ) during HDT , while H-ficolin was essentially unaffected .
RESULTS	MAp44 , a down-regulator of the lectin pathway , decreased initially ( mean 78 ng ml ) in the recovery phase followed by an increase ( mean 131 ng ml ) .
CONCLUSIONS	Alterations in MBL and ficolin levels were modest and with our current knowledge do not lead to overt immunodeficiency .
CONCLUSIONS	Pronounced changes occurred when the subjects resumed the upright position .
CONCLUSIONS	In selected individuals , these changes appear to be a conserved response to HDT .

###24633440
BACKGROUND	Optimisation of patient comfort during flexible bronchoscopy is achieved with the use of intravenous sedation and vocal anaesthesia .
METHODS	The effect of transcricoid lignocaine injection was investigated with regards to ease of procedure and frequency of cough .
METHODS	A single-blinded study was carried out and two visual analogue scales were used as markers of efficacy .
METHODS	Treatment groups were matched for age , gender and total dose of lignocaine administered .
RESULTS	The results highlighted a significant improvement in the perceived ease of procedure ( p < 0.0001 ) and frequency of coughing during the procedure ( p < 0.0001 ) .
CONCLUSIONS	The findings of the study demonstrate that the use of transcricoid injection of lignocaine provided a safe adjunct for anaesthesia in flexible bronchoscopy .

###24882907
OBJECTIVE	To evaluate a novel sleep education program for low-income preschool children and their families .
METHODS	Randomized trial of an educational intervention .
METHODS	Community-based .
METHODS	Head Start preschool families ( n = 152 ) in greater Lansing and Detroit , Michigan .
METHODS	Classrooms or Head Start sites were randomized to an intervention group ( prompt intervention ) versus a control group ( delayed intervention ) .
METHODS	Parents attended a one-time , 45-min sleep education program and preschoolers received 2 w ( 320 total min ) of classroom sleep curriculum .
METHODS	Parent knowledge , attitudes , self-efficacy , and beliefs were assessed as the primary outcomes just before the 45-min sleep intervention , immediately postintervention , and approximately 1 mo postintervention .
METHODS	Parents reported their child 's bedtimes and wake times on 7-day sleep diaries at baseline and at 1-mo follow-up .
METHODS	Average weeknight sleep durations and bedtimes served as secondary outcomes .
RESULTS	Linear mixed models showed a time treatment effect for parents ' knowledge , attitudes , and self-efficacy ( each P < 0.05 ) but not beliefs .
RESULTS	These improvements were found immediately postintervention but were not retained at 1-mo follow-up .
RESULTS	Children in the intervention group improved their weeknight sleep duration at 1-mo follow-up by 30 min ( 11.0 0.9 h vs. 10.5 1.0 hours at baseline ) compared to controls ( 10.4 0.9 h versus 10.5 0.9 h at baseline ) ( P = 0.04 for difference between groups ) .
RESULTS	Children did not show statistically significant improvements in bedtime .
CONCLUSIONS	Educational interventions in early childhood can have an effect on parents ' sleep knowledge , attitudes , and self-efficacy , and on children 's sleep behavior .
CONCLUSIONS	However , repeated exposure to the new information may be important for parents as well as their children .

###24631433
OBJECTIVE	The objective of the study was to estimate the effect of Burch and fascial sling surgery on out-of-pocket urinary incontinence ( UI ) management costs at 24 months postoperatively and identify predictors of change in cost among women enrolled in a randomized trial comparing these procedures .
METHODS	Resources used for UI management ( supplies , laundry , dry cleaning ) were self-reported by 491 women at baseline and 24 months after surgery , and total out-of-pocket costs for UI management ( in 2012 US dollars ) were estimated .
METHODS	Data from the 2 surgical groups were combined to examine the change in cost for UI management over 24 months .
METHODS	Univariate and bivariate changes in cost were analyzed using the Wilcoxon signed rank test .
METHODS	Predictors of change in cost were examined using multivariate mixed models .
RESULTS	At baseline mean ( SD ) age of participants was 53 10 years , and the frequency of weekly UI episodes was 23 21 .
RESULTS	Weekly UI episodes decreased by 86 % at 24 months ( P < .001 ) .
RESULTS	The mean weekly cost was $ 16.60 $ 27.00 ( median $ 9.39 ) at baseline and $ 4.57 $ 15.00 ( median $ 0.10 ) at 24 months ( P < .001 ) , a decrease of 72 % .
RESULTS	In multivariate analyses , cost decreased by $ 3.38 $ 0.77 per week for each decrease of 1 UI episode per day ( P < .001 ) and was strongly associated with greater improvement in Urogenital Distress Inventory and Incontinence Impact Questionnaire scores ( P < .001 ) and decreased 24-hour pad weight ( P < .02 ) .
CONCLUSIONS	Following Burch or fascial sling surgery , the UI management cost at 24 months decreased by 72 % ( $ 625 per woman per year ) and was strongly associated with decreasing UI frequency .
CONCLUSIONS	Reduced out-of-pocket expenses may be a benefit of these established urinary incontinence procedures .

###24885101
BACKGROUND	To describe and evaluate the effectiveness of tailored intervention on village doctor 's use of electronic health records ( EHR ) in rural community health services in less developed areas .
METHODS	Ten townships were selected .
METHODS	In each township , two similar health service station ( CHSS ) were chosen .
METHODS	One was randomly as allocated to the intervention group , the other to the control group .
METHODS	Over six monthly visits , a structured on-site intervention including education , supervision and technical support was provided to village doctors in the intervention group tailored to their needs .
METHODS	The Control group received no visits .
METHODS	A sample of 20 families from each CHSS was randomly chosen .
METHODS	An online evaluation of each family 's EHR was conducted by the investigators at baseline and at the end of the 6month intervention .
RESULTS	In the intervention group , the proportion of households with complete records increased : basic personal information from 2.6 % to 32.5 % , ( Z = -15.099 , P = 0.000 ) and health education records from 0.3 % to 1.6 % ( Z = -4.459 , P = 0.000 ) .
RESULTS	Similarly at baseline none of the 80 elders had her records .
RESULTS	This increased in the intervention group to 16.4 % recorded in part and 37.0 % in full ( Z = -7.480 , P = 0.000 ) .
RESULTS	The proportion of complete health management records for children aged 1 to 2years and 3 to 6years increased from 28.6 % and 33.3 % to 66.7 % and 74.2 % respectively ( the difference of children group 3 to 6years of age was statistically significant , Z = -3.860 , p = 0.000 ) .
RESULTS	The proportion of complete basic clinic records in the intervention group increased from 7.6 % to 13.9 % ( Z = -3.252 , P = 0.001 ) .
RESULTS	There were no significant differences in the control group .
CONCLUSIONS	The pilot study showed that a on-site education , supervision and technical support tailored to their needs was associated with improvements in village doctors use of EHR .
CONCLUSIONS	This model is worthy of implementation in other rural areas .

###25158897
BACKGROUND	Blood management is critical in total knee arthroplasty ( TKA ) .
BACKGROUND	In bilateral , single stage TKA , blood loss seems more prominent .
BACKGROUND	We believe it is important to control all potential bleeding within the wound tissue .
OBJECTIVE	The purpose of the study was to evaluate a series of topical procedures used to reduce blood loss and transfusion in single-stage bilateral cemented total knee arthroplasty : antifibrinolysis with tranexamic acid , vasoconstriction with epinephrine , sealing of the bone section intraoperatively , and closure of the drainage tube within the first 4 h postoperatively .
METHODS	Patients with osteoarthritis of the knees were randomly divided into two groups .
METHODS	In group A , 5 ml ( 25 mg/ml ) tranexamic acid ( TXA ) and 5 ml analgesic containing epinephrine ( 3 g/ml ) solution were injected at several points into the posterior capsule before installation of the prosthesis .
METHODS	The femoral medullar canal was closed with autograft bone and then sealed compressively with cement .
METHODS	Before the tourniquet was released , 10 ml TXA solution and 10 ml analgesic containing epinephrine were injected at several points into the periosteum , synovium , joint capsule , tendons , and deep fascia tissue ( injection of analgesic containing epinephrine into subcutaneous fat and dermis was avoided ) .
METHODS	The residual nail holes in the bone and the uncovered bone section were covered with bone wax .
METHODS	The tourniquet was then removed , and active bleeding points were stanched .
METHODS	TXA solution ( 20 ml ) was injected into the articular cavity after wound closure .
METHODS	The drainage tube was clamped for 4 h , then opened .
METHODS	In group B , injection of analgesic containing epinephrine into soft tissue , control of active bleeding , and clamping of the drainage tube for 4-h , only , were performed .
RESULTS	Ninety patients were enrolled in the study .
RESULTS	Compared with those in group B , intraoperative blood loss , drainage volume , total postoperative blood loss , and number of patients requiring allogenic blood transfusion were significantly reduced in group A.
RESULTS	There was no significant difference between the incidence of complications in the groups .
CONCLUSIONS	Our topical procedures enable effective and safe reduction of blood loss and the number of patients requiring transfusion in single-stage bilateral osteoarthritic TKA .

###25923680
OBJECTIVE	Evaluate the discal morpho-structural changes as a predictive sign in the clinical outcome after ozone therapy in lumbar disc herniation using the T2-shine through effect in diffusion-weighted imaging ( DWI ) .
METHODS	One hundred and fifty-four patients suffering from lumbosciatica ( 89 men and 65 women ; age range , 23-62 years ) were included , previous MR study performed with FSE-T2 and T2-fat , SE-T1 and DWI sequences , and were randomly assigned to two groups .
METHODS	Seventy-seven patients ( control group ) underwent conservative treatment with intraforaminal injection of steroid and anaesthetic .
METHODS	The remaining 77 patients ( study group ) underwent the same treatment with the addition of oxygen-ozone ( O2-O3 ) .
METHODS	During the following six months , a MRI follow-up with the same sequences was performed .
METHODS	An intervertebral disc volumetric analysis ( IDVA ) , DWI signal score and post treatment clinical outcome evaluation were performed for an assessment of hernia reduction .
METHODS	test , Student 's t test and analysis of covariance were used for comparison of variables .
RESULTS	In the study group , 58 of 77 patients had a successful outcome ( responders ) .
RESULTS	In the responders group , DWI T2-shine through effect was present during MRI follow-up and in particular in 53 of 77 patients in six months of follow-up ( p < 0.05 ) .
RESULTS	Moreover , in the same group a statistically significant disc shrinkage was shown by IDVA in sixth months of follow-up ( p < 0.05 ) .
CONCLUSIONS	T2-shine through effect in DWI is present before morphological disc reduction and moreover could be considered as a predictive sign of response to oxygen-ozone treatment .

###25388660
BACKGROUND	This update outlines changes to the MObile Technology for Improved Family Planning study statistical analysis plan and plans for long-term follow-up .
BACKGROUND	These changes result from obtaining additional funding and the decision to restrict the primary analysis to participants with available follow-up data .
BACKGROUND	The changes were agreed prior to finalising the statistical analysis plan and sealing the dataset .
METHODS	The primary analysis will now be restricted to subjects with data on the primary outcome at 4-month follow-up .
METHODS	The extreme-case scenario , where all those lost to follow-up are counted as non-adherent , will be used in a sensitivity analysis .
METHODS	In addition to the secondary outcomes outlined in the protocol , we will assess the effect of the intervention on long-acting contraception ( implant , intra-uterine device and permanent methods ) .
METHODS	To assess the long-term effect of the intervention , we plan to conduct additional 12-month follow-up by telephone self-report for all the primary and secondary outcomes used at 4 months .
METHODS	All participants provided informed consent for this additional follow-up when recruited to the trial .
METHODS	Outcome measures and analysis at 12 months will be similar to those at the 4-month follow-up .
METHODS	The primary outcomes of the trial will be the use of an effective modern contraceptive method at 4 months and at 12 months post-abortion .
METHODS	Secondary outcomes will include long-acting contraception use , self-reported pregnancy , repeat abortion and contraception use over the 12-month post-abortion period .
CONCLUSIONS	Restricting the primary analysis to those with follow-up data is the standard approach for trial analysis and will facilitate comparison with other trials of interventions designed to increase contraception uptake or use .
CONCLUSIONS	Undertaking 12-month trial follow-up will allow us to evaluate the long-term effect of the intervention .
BACKGROUND	ClinicalTrials.gov NCT01823861 .

###26299229
BACKGROUND	Diuretic unresponsiveness often occurs during hospital admission for acute heart failure ( AHF ) and is associated with adverse outcome .
BACKGROUND	This study aims to investigate determinants , clinical outcome , and the effects of nesiritide on diuretic response early after admission for AHF .
METHODS	Diuretic response , defined as weight loss per 40 mg of furosemide or equivalent , was examined from hospital admission to 48 hours in 4,379 patients from the ASCEND-HF trial .
METHODS	As an additional analysis , a urinary diuretic response metric was investigated in 5,268 patients using urine volume from hospital admission to 24 hours per 40 mg of furosemide or equivalent .
RESULTS	Mean diuretic response was -0.42 kg/40 mg of furosemide ( interquartile range -1.0 , -0.05 ) .
RESULTS	Poor responders had lower blood pressure , more frequent diabetes , long-term use of loop diuretics , poorer baseline renal function , and lower urine output ( all P < .01 ) .
RESULTS	Randomized nesiritide treatment was not associated with diuretic response ( P = .987 ) .
RESULTS	Good diuretic response was independently associated with a significantly decreased risk of 30-day all-cause mortality or heart failure rehospitalization ( odds ratio 0.44 , 95 % CI 0.29-0 .65 , highest vs lowest quintile , P < .001 ) .
RESULTS	Diuretic response based on urine output per 40 mg of furosemide showed similar results in terms of clinical predictors , association with outcome , and the absence of an effect of nesiritide .
CONCLUSIONS	Poor diuretic response early after hospital admission for AHF is associated with low blood pressure , renal impairment , low urine output , and an increased risk of death or rehospitalization early after discharge .
CONCLUSIONS	Nesiritide had a neutral effect on diuretic response .

###25440793
BACKGROUND	- Blockers have a class 1a recommendation in the treatment of patients with ST-elevation myocardial infarctions ( STEMIs ) , as they are associated with a reduced mortality , recurrent myocardial infarction , life-threatening arrhythmias , and with prevention of unfavorable left ventricular remodeling .
BACKGROUND	Whether early administration before primary percutaneous coronary intervention ( PCI ) of intravenous - blockers reduces the infarct size in the current era is unknown .
OBJECTIVE	We postulate that the early administration of - blockers will reduce the myocardial infarcted area as assessed by magnetic resonance imaging ( MRI ) at 30 days .
METHODS	In a multinational , multicenter , double-blind , placebo-controlled , randomized trial , patients with symptoms and signs of STEMI and transferred to a hospital for primary PCI will be randomized in a 1:1 fashion to intravenous metoprolol ( 5 mg twice daily ) administration or placebo .
METHODS	Before admission , study treatment will be started as soon as possible after the diagnosis of STEMI .
METHODS	After admission , primary PCI will be performed as per standard of care .
METHODS	After primary PCI , medical treatment will occur as per current guidelines in all patients , including the use of oral - blockers .
METHODS	The primary end point is the myocardial infarct size as assessed by MRI at 30 days .
METHODS	Based on a superiority design and assuming an 18 % relative infarct size reduction ( from 28 % to 23.5 % ) , 408 patients are required to be enrolled , accounting for 20 % drop-out ( = .05 and power = 80 % ) .
CONCLUSIONS	The EARLY-BAMI trial is a multinational , multicenter , double-blind , placebo-controlled , randomized clinical trial that will investigate the impact of intravenous metoprolol administration before primary PCI for STEMI on myocardial infarct size as measured with MRI at 30 days .

###25282031
OBJECTIVE	This randomized controlled multicenter trial evaluated coenzyme Q10 ( CoQ10 ) as adjunctive treatment in chronic heart failure ( HF ) .
BACKGROUND	CoQ10 is an essential cofactor for energy production and is also a powerful antioxidant .
BACKGROUND	A low level of myocardial CoQ10 is related to the severity of HF .
BACKGROUND	Previous randomized controlled trials of CoQ10 in HF were underpowered to address major clinical endpoints .
METHODS	Patients with moderate to severe HF were randomly assigned in a 2-year prospective trial to either CoQ10 100 mg 3 times daily or placebo , in addition to standard therapy .
METHODS	The primary short-term endpoints at 16 weeks were changes in New York Heart Association ( NYHA ) functional classification , 6-min walk test , and levels of N-terminal pro-B type natriuretic peptide .
METHODS	The primary long-term endpoint at 2 years was composite major adverse cardiovascular events as determined by a time to first event analysis .
RESULTS	A total of 420 patients were enrolled .
RESULTS	There were no significant changes in short-term endpoints .
RESULTS	The primary long-term endpoint was reached by 15 % of the patients in the CoQ10 group versus 26 % in the placebo group ( hazard ratio : 0.50 ; 95 % confidence interval : 0.32 to 0.80 ; p = 0.003 ) by intention-to-treat analysis .
RESULTS	The following secondary endpoints were significantly lower in the CoQ10 group compared with the placebo group : cardiovascular mortality ( 9 % vs. 16 % , p = 0.026 ) , all-cause mortality ( 10 % vs. 18 % , p = 0.018 ) , and incidence of hospital stays for HF ( p = 0.033 ) .
RESULTS	In addition , a significant improvement of NYHA class was found in the CoQ10 group after 2 years ( p = 0.028 ) .
CONCLUSIONS	Long-term CoQ10 treatment of patients with chronic HF is safe , improves symptoms , and reduces major adverse cardiovascular events .
CONCLUSIONS	( Coenzyme Q10 as adjunctive treatment of chronic heart failure : a randomised , double-blind , multicentre trial with focus on SYMptoms , BIomarker status [ Brain-Natriuretic Peptide ( BNP ) ] , and long-term Outcome [ hospitalisations/mortality ] ; ISRCTN94506234 ) .

###24722949
BACKGROUND	In ARDS , the extent of fibroproliferative activity on chest high-resolution CT ( HRCT ) scan has been reported to correlate with poorer short-term outcomes and pulmonary-associated quality of life .
BACKGROUND	However , clinical factors associated with HRCT scan fibroproliferation are incompletely characterized .
BACKGROUND	We questioned if lung compliance assessed at the bedside would be associated with fibroproliferation on HRCT scans obtained during the resolution phase of ARDS .
METHODS	We used data from a published randomized , controlled clinical trial in ARDS .
METHODS	All patients were cared for using a low tidal volume strategy .
METHODS	Demographic data and ventilator parameters were examined in association with radiologic scores from chest HRCT scans obtained 14 days after diagnosis .
RESULTS	Data from 82 patients with ARDS were analyzed .
RESULTS	Average static respiratory compliance over the first 14 days after diagnosis was inversely associated with chest HRCT scan reticulation ( = -0.46 ) ; this relationship persisted in multivariable analysis including APACHE ( Acute Physiology and Chronic Health Evaluation ) II scores , initial Pao2/Fio2 , pneumonia diagnosis , and ventilator days .
RESULTS	Average static respiratory compliance was also lower among patients with bronchiectasis at day 14 ( P = .007 ) .
RESULTS	Initial static respiratory compliance obtained within the first day after ARDS diagnosis was correlated inversely with the presence of HRCT scan reticulation ( = -0.38 ) and was lower among patients who demonstrated bronchiectasis on the day 14 HRCT scan ( P = .008 ) .
CONCLUSIONS	In patients with ARDS , diminished lung compliance measured bedside was associated with radiologic fibroproliferation 14 days post diagnosis .
CONCLUSIONS	Establishing factors that predispose to development of excessive fibroproliferation with subsequent confirmation by chest HRCT scan represents a promising strategy to identify patients with ARDS at risk for poorer clinical outcomes .

###25247485
BACKGROUND	To tackle the problems associated with high-dose dexamethasone ( HD-DXM ) in patients with immune thrombocytopenia ( ITP ) .
OBJECTIVE	To compare the efficacy of HD-DXM with or without low-dose dexamethasone maintenance in untreated ITP patients .
RESULTS	Dexamethasone ( 40 mg/day ) was given in 4-day pulses every 14 days for 3 cycles in 61 patients with ITP .
RESULTS	Among them , 30 cases were given dexamethasone ( 0.035 mg/kg per day ) for maintenance between pulsed HD-DXM and after 3 HD-DXM courses ( HD-DXM-M group ) and another 31 cases did not receive dexamethasone maintenance ( HD-DXM-nM group ) .
RESULTS	The control group comprised the patients who received prednisone ( prednisone group ) .
RESULTS	The following results were obtained : ( 1 ) at the end of the 3rd cycle , the overall response rate ( ORR ) was higher in the HD-DXM group than in the prednisone group ; ( 2 ) the ORR of the HD-DXM group peaked after the 3rd cycle ; ( 3 ) the ORR after each course was higher in the HD-DXM-M group than in the HD-DXM-nM group ; ( 4 ) in the 12th month after HD-DXM discontinuation , the relapse rate of the HD-DXM-M group was lower than that of the other groups ( prednisone and HD-DXM-nM ) .
CONCLUSIONS	Treatment with 3 cycles of HD-DXM pulses with low-dose dexamethasone maintenance is an effective method for untreated ITP .

###24229823
BACKGROUND	Budesonide inhalation suspension ( BIS ) and montelukast provide acceptable asthma control , whereas overall measures favored BIS in children aged 2 to 8 years with mild persistent asthma .
OBJECTIVE	We compared BIS and montelukast over a 1-year period in children aged 2 to 4 years with asthma .
METHODS	Data were derived from a 52-week , open-label , randomized , active-controlled , multicenter study ( NCT00641472 ) .
METHODS	Children with mild asthma received either BIS 0.5 mg or montelukast 4 to 5 mg once daily .
METHODS	Patients were stepped up to twice-daily BIS or oral corticosteroids for mild or severe asthma worsening , respectively .
METHODS	Primary efficacy assessment was time to first additional asthma medication for exacerbation over 52 weeks .
RESULTS	Two hundred two patients , age 2 to 4 years , received BIS ( n = 105 ) or montelukast ( n = 97 ) .
RESULTS	No difference was observed between the BIS and montelukast groups in median time to first additional asthma medication over 52 weeks ( 183 vs 86 days ) .
RESULTS	Statistically significant differences were observed in favor of BIS over montelukast in the percentage of patients requiring oral steroids at 52 weeks ( 21.9 % vs 37.1 % ; P = .022 ) , the rate ( number/patient/year ) of additional courses of medication ( 1.35 vs 2.30 ; P = .003 ) , the rate of additional oral steroid therapy ( 0.44 vs 0.88 ; P = .008 ) , and caregivers ' ability to manage the patient 's symptoms ( P = .026 ) .
RESULTS	Both treatments were well tolerated .
CONCLUSIONS	BIS and montelukast provided acceptable asthma control in children aged 2 to 4 years with mild persistent asthma with no significant difference between treatments in the primary end point ; however , several secondary outcomes showed statistically significant differences ( and many had numerical differences ) in favor of BIS over montelukast .

###24368060
BACKGROUND	Anxiety and affective disorders can be disabling and have a major impact on the ability to work .
BACKGROUND	In Denmark , people with a mental disorder , and mainly non-psychotic disorders , represent a substantial and increasing part of those receiving disability pensions .
BACKGROUND	Previous studies have indicated that Individual Placement and Support ( IPS ) has a positive effect on employment when provided to people with severe mental illness .
BACKGROUND	This modified IPS intervention is aimed at supporting people with recently diagnosed anxiety or affective disorders in regaining their ability to work and facilitate their return to work or education .
OBJECTIVE	To investigate whether an early modified IPS intervention has an effect on employment and education when provided to people with recently diagnosed anxiety or affective disorders in a Danish context .
METHODS	The trial is a randomised , assessor-blinded , clinical superiority trial of an early modified IPS intervention in addition to treatment-as-usual compared to treatment-as-usual alone for 324 participants diagnosed with an affective disorder or anxiety disorder living in the Capital Region of Denmark .
METHODS	The primary outcome is competitive employment or education at 24 months .
METHODS	Secondary outcomes are days of competitive employment or education , illness symptoms and level of functioning including quality of life at follow-up 12 and 24 months after baseline .
CONCLUSIONS	If the modified IPS intervention is shown to be superior to treatment-as-usual , a larger number of disability pensions can probably be avoided and long-term sickness absences reduced , with major benefits to society and patients .
CONCLUSIONS	This trial will add to the evidence of how best to support people 's return to employment or education after a psychiatric disorder .
BACKGROUND	NCT01721824 .

###24658475
BACKGROUND	Chronic pain and disability of the arm , shoulder , and hand severely affect labor market participation .
BACKGROUND	Ergonomic training and education is the default strategy to reduce physical exposure and thereby prevent aggravation of pain .
BACKGROUND	An alternative strategy could be to increase physical capacity of the worker by physical conditioning .
OBJECTIVE	To investigate the effect of 2 contrasting interventions , conventional ergonomic training ( usual care ) versus resistance training , on pain and disability in individuals with upper limb chronic pain exposed to highly repetitive and forceful manual work .
METHODS	Examiner-blinded , parallel-group randomized controlled trial with allocation concealment .
METHODS	Slaughterhouses located in Denmark , Europe .
METHODS	Sixty-six adults with chronic pain in the shoulder , elbow/forearm , or hand/wrist and work disability were randomly allocated to 10 weeks of specific resistance training for the shoulder , arm , and hand muscles for 3 x 10 minutes per week , or ergonomic training and education ( usual care control group ) .
METHODS	Pain intensity ( average of shoulder , arm , and hand , scale 0 - 10 ) was the primary outcome , and disability ( Work module of DASH questionnaire ) as well as isometric shoulder and wrist muscle strength were secondary outcomes .
RESULTS	Pain intensity , disability , and muscle strength improved more following resistance training than usual care ( P < 0.001 , P = 0.05 , P < 0.0001 , respectively [ corrected ] ) .
RESULTS	Pain intensity decreased by 1.5 points ( 95 % confidence interval -2.0 to -0.9 ) following resistance training compared with usual care , corresponding to an effect size of 0.91 ( Cohen 's d ) .
CONCLUSIONS	Blinding of participants is not possible in behavioral interventions .
CONCLUSIONS	However , at baseline outcome expectations of the 2 interventions were similar .
CONCLUSIONS	Resistance training at the workplace results in clinical relevant improvements in pain , disability , and muscle strength in adults with upper limb chronic pain exposed to highly repetitive and forceful manual work .
BACKGROUND	NCT01671267 .

###25765835
OBJECTIVE	Diabetes is a serious metabolic disorder and oxidative stress and inflammation contribute to its pathogenesis and complications .
OBJECTIVE	Since Silybum marianum ( L. ) Gaertn .
OBJECTIVE	( silymarin ) extract is an antioxidant with anti-inflammatory properties , this randomized clinical trial was conducted to evaluate the effects of silymarin supplementation on oxidative stress indices and hs-CRP in type 2 diabetes mellitus patients .
METHODS	For the present paralleled , randomized , triple-blinded , placebo-controlled clinical trial , 40 type 2 diabetes patients aged 25-50 yr old and on stable medication were recruited from the Iranian Diabetes Society and endocrinology clinics in East Azarbayjan ( Tabriz , Iran ) and randomly assigned into two groups .
METHODS	Patients in the silymarin treatment group received 140mg , thrice daily of dried extracts of Silybum marianum ( n = 20 ) and those in the placebo group ( n = 20 ) received identical placebos for 45 days .
METHODS	Data pertaining to height , weight , waist circumference and BMI , as well as food consumption , were collected at base line and at the conclusion of the study .
METHODS	Fasting blood samples were obtained and antioxidant indices and hs-CRP were assessed at baseline , as well as at the end of the trial .
RESULTS	All 40 patients completed the study and did not report any adverse effects or symptoms with the silymarin supplementation .
RESULTS	Silymarin supplementation significantly increased superoxide dismutase ( SOD ) , glutathione peroxidase ( GPX ) activity and total antioxidant capacity ( TAC ) compared to patients taking the placebo , by 12.85 % , 30.32 % and 8.43 % , respectively ( p < 0.05 ) .
RESULTS	There was a significant reduction in hs-CRP levels by 26.83 % ( p < 0.05 ) in the silymarin group compared to the placebo group .
RESULTS	Malondialdehyde ( MDA ) concentration significantly decreased by 12.01 % ( p < 0.05 ) in the silymarin group compared to the baseline .
CONCLUSIONS	Silymarin supplementation improves some antioxidant indices ( SOD , GPX and TAC ) and decrease hs-CRP levels in T2DM patients .

###25916341
BACKGROUND	In previous phase 1-2 clinical trials involving older adults , a subunit vaccine containing varicella-zoster virus glycoprotein E and the AS01B adjuvant system ( called HZ/su ) had a clinically acceptable safety profile and elicited a robust immune response .
METHODS	We conducted a randomized , placebo-controlled , phase 3 study in 18 countries to evaluate the efficacy and safety of HZ/su in older adults ( 50 years of age ) , stratified according to age group ( 50 to 59 , 60 to 69 , and 70 years ) .
METHODS	Participants received two intramuscular doses of the vaccine or placebo 2 months apart .
METHODS	The primary objective was to assess the efficacy of the vaccine , as compared with placebo , in reducing the risk of herpes zoster in older adults .
RESULTS	A total of 15,411 participants who could be evaluated received either the vaccine ( 7698 participants ) or placebo ( 7713 participants ) .
RESULTS	During a mean follow-up of 3.2 years , herpes zoster was confirmed in 6 participants in the vaccine group and in 210 participants in the placebo group ( incidence rate , 0.3 vs. 9.1 per 1000 person-years ) in the modified vaccinated cohort .
RESULTS	Overall vaccine efficacy against herpes zoster was 97.2 % ( 95 % confidence interval [ CI ] , 93.7 to 99.0 ; P < 0.001 ) .
RESULTS	Vaccine efficacy was between 96.6 % and 97.9 % for all age groups .
RESULTS	Solicited reports of injection-site and systemic reactions within 7 days after vaccination were more frequent in the vaccine group .
RESULTS	There were solicited or unsolicited reports of grade 3 symptoms in 17.0 % of vaccine recipients and 3.2 % of placebo recipients .
RESULTS	The proportions of participants who had serious adverse events or potential immune-mediated diseases or who died were similar in the two groups .
CONCLUSIONS	The HZ/su vaccine significantly reduced the risk of herpes zoster in adults who were 50 years of age or older .
CONCLUSIONS	Vaccine efficacy in adults who were 70 years of age or older was similar to that in the other two age groups .
CONCLUSIONS	( Funded by GlaxoSmithKline Biologicals ; ZOE-50 ClinicalTrials.gov number , NCT01165177 . )

###25499006
BACKGROUND	Optimal emergent management of traumatic hemorrhagic shock patients requires a better understanding of treatment provided in the prehospital/Emergency Medical Services ( EMS ) and emergency department ( ED ) settings .
BACKGROUND	Hypothesis/Problem Described in this research are the initial clinical status , airway management , fluid and blood infusions , and time course of severely-injured hemorrhagic shock patients in the EMS and ED settings from the diaspirin cross-linked hemoglobin ( DCLHb ) clinical trial .
METHODS	Data were analyzed from 17 US trauma centers gathered during a randomized , controlled , single-blinded efficacy trial of a hemoglobin solution ( DCLHb ) as add-on therapy versus standard therapy .
RESULTS	Among the 98 randomized patients , the mean EMS Glasgow Coma Scale ( GCS ) was 10.6 ( SD = 5.0 ) , the mean EMS revised trauma score ( RTS ) was 6.3 ( SD = 1.9 ) , and the mean injury severity score ( ISS ) was 31 ( SD = 17 ) .
RESULTS	Upon arrival to the ED , the GCS was 20 % lower ( 7.8 ( SD = 5.3 ) vs 9.7 ( SD = 6.3 ) ) and the RTS was 12 % lower ( 5.3 ( SD = 2.0 ) vs 6.0 ( SD = 2.1 ) ) than EMS values in blunt trauma patients ( P < .001 ) .
RESULTS	By ED disposition , 80 % of patients ( 78/98 ) were intubated .
RESULTS	Rapid sequence intubation ( RSI ) was utilized in 77 % ( 60/78 ) , most often utilizing succinylcholine ( 65 % ) and midazolam ( 50 % ) .
RESULTS	The mean crystalloid volume infused was 4.2 L ( SD = 3.4 L ) , 80 % of which was infused within the ED .
RESULTS	Emergency department blood transfusion occurred in 62 % of patients , with an average transfused volume of 1.2 L ( SD = 2.0 L ) .
RESULTS	Blunt trauma patients received 2.1 times more total fluids ( 7.4 L vs 3.5 L , < .001 ) and 2.4 times more blood ( 2.4 L vs 1.0 L , P < .001 ) .
RESULTS	The mean time of patients taken from injury site to operating room ( OR ) was 113 minutes ( SD = 87 minutes ) .
RESULTS	Twenty-one ( 30 % ) of the 70 patients taken to the OR from the ED were sent within 60 minutes of the estimated injury time .
RESULTS	Penetrating trauma patients were taken to the OR 52 % sooner than blunt trauma patients ( 72 minutes vs 149 minutes , P < .001 ) .
CONCLUSIONS	Both GCS and RTS decreased prior to ED arrival in blunt trauma patients .
CONCLUSIONS	Intubation was performed using RSI , and crystalloid infusion of three times the estimated blood loss volume ( L ) and blood transfusion of the estimated blood loss volume ( L ) were provided in the EMS and ED settings .
CONCLUSIONS	Surgical intervention for these trauma patients most often occurred more than one hour from the time of injury .
CONCLUSIONS	Penetrating trauma patients received surgical intervention more rapidly than those with a blunt trauma mechanism .

###26295664
OBJECTIVE	The purpose of this study was to use CT texture analysis to predict overall survival ( OS ) in patients with metastatic melanoma and stable disease ( SD ) according to the Response Evaluation Criteria in Solid Tumors ( RECIST ) on initial posttherapy CT images .
METHODS	This retrospective study included 42 patients with metastatic melanoma who received bevacizumab therapy in the context of a randomized prospective phase II clinical trial .
METHODS	Target lesions on the baseline and initial posttherapy contrast-enhanced CT examinations were evaluated by CT texture analysis using TexRAD software before and after image filtering in patients with RECIST SD on initial posttherapy images .
METHODS	Cox proportional hazards models were used to assess the associations of CT texture analysis measurements and of other patient factors with OS .
METHODS	The AUC was used to evaluate predictive accuracy .
RESULTS	In multivariate analysis ( in 23 patients with RECIST SD ; median OS , 1.51 years ) , absolute change in mean positive pixels at spatial scaling filter of 4 mm , change in tumor size , and baseline serum lactate dehydrogenase ( LDH ) level were predictors of OS ( hazard ratio [ HR ] = 5.05 for decrease in mean positive pixels at spatial scaling filter of 4 mm vs increase , p = 0.007 ; HR = 4.14 for > 5 % increase in tumor size vs otherwise , p = 0.025 ; and HR = 1.29 for every 100 IU/L increase in baseline LDH level , p = 0.068 ) .
RESULTS	A prognostic index containing these three factors was highly accurate for predicting OS at 18 months ( AUC = 0.917 ) .
CONCLUSIONS	In patients with metastatic melanoma and RECIST SD on initial post-therapy CT images , a model incorporating CT texture analysis of target lesions , tumor size changes , and baseline LDH levels was highly accurate in predicting OS .

###24344104
OBJECTIVE	To determine the vitamin D dose necessary to achieve serum 25-hydroxyvitamin D ( 25 ( OH ) D ) concentration 20 ng/mL during infancy .
METHODS	A randomized , double-blind , placebo-controlled trial in New Zealand .
METHODS	Pregnant mothers , from 27 weeks ' gestation to birth , and then their infants , from birth to age 6 months , were randomly assigned to 1 of 3 mother/infant groups : placebo/placebo , vitamin D3 1000/400 IU , or vitamin D3 2000/800 IU .
METHODS	Serum 25 ( OH ) D and calcium concentrations were measured at enrollment , 36 weeks ' gestation , in cord blood , and in infants at 2 , 4 , and 6 months of age .
RESULTS	Two-hundred-and-sixty pregnant women were randomized .
RESULTS	At enrollment , the proportions with serum 25 ( OH ) D 20 ng/mL for placebo , lower-dose , and higher-dose groups were 54 % , 64 % , and 55 % , respectively .
RESULTS	The proportion with 25 ( OH ) D 20 ng/mL was larger in both intervention groups at 36 weeks ' gestation ( 50 % , 91 % , 89 % , P < .001 ) .
RESULTS	In comparison with placebo , the proportion of infants with 25 ( OH ) D 20 ng/mL was larger in both intervention groups to age 4 months : cord blood ( 22 % , 72 % , 71 % , P < .001 ) , 2 months ( 50 % , 82 % , 92 % , P < .001 ) , and 4 months ( 66 % , 87 % , 87 % , P = .004 ) , but only in the higher-dose group at age 6 months ( 74 % , 82 % , 89 % , P = .07 ; higher dose versus placebo P = .03 , lower dose versus placebo P = .21 ) .
CONCLUSIONS	Daily vitamin D supplementation during pregnancy and then infancy with 1000/400 IU or 2000/800 IU increases the proportion of infants with 25 ( OH ) D 20 ng/mL , with the higher dose sustaining this increase for longer .

###24385079
OBJECTIVE	Botulinum toxin injection for lateral canthal rhytids has been reported to result in dry eye , but its effect on tear film stability and tear production has not been studied thoroughly .
OBJECTIVE	To investigate the effect of botulinum toxin type A on tear film stability and tear production after treatment of lateral canthal rhytids .
METHODS	We performed a clinical intervention study at a regional hospital in Taiwan of 58 women 30 to 60 years of age with lateral canthal rhytids from January 1 through December 31 , 2011 .
METHODS	Botulinum toxin type A at 2 different preparations and doses ( dose A : 3 injections of 2 U in 0.05 mL of normal saline per injection ; dose B : 3 injections of 4 U in 0.05 mL of normal saline per injection ) was injected at the lateral canthal areas .
METHODS	One eye of each study participant was randomly chosen for dose A , and the other eye received dose B.
METHODS	Baseline tear film break-up time ( TBUT ) and Schirmer tests without and with anesthesia were measured before and at 1 week , 1 month , 3 months , and 6 months after botulinum toxin injection .
METHODS	The TBUT and Schirmer test results were compared between different periods and doses .
RESULTS	The TBUT decreased significantly at 1 week after botulinum toxin type A injection ( P = .003 ) , and the effect persisted at 1 month and 3 months after treatment ( P = .01 and .02 , respectively ) .
RESULTS	In younger participants , the TBUT recovered faster than in older patients .
RESULTS	The results of the Schirmer tests without and with anesthesia decreased gradually , with significant reduction at 1 month after treatment ( P = .05 and .02 , respectively ) and then recovered gradually .
RESULTS	Both the TBUT and Schirmer test results decreased more in eyes that received dose B than in those that received dose A ; however , none of the differences were statistically significant .
CONCLUSIONS	Tear film stability decreased as early as 1 week after botulinum toxin type A treatment for lateral canthal rhytids , and the effect persisted for more than 3 months .
CONCLUSIONS	Tear production decreased to the trough at 1 month after treatment and then recovered gradually .

###24878174
OBJECTIVE	Contrast sensitivity sometimes increases in patients with open-angle glaucoma when intraocular pressure ( IOP ) is decreased .
OBJECTIVE	Although often interpreted as demonstrating reversible glaucoma-induced dysfunction , this result , if true , could simply reflect a general relationship between sensitivity and IOP in visual mechanisms unaffected by glaucoma .
OBJECTIVE	To investigate this relationship , we test the hypothesis that reducing IOP in eyes without glaucoma ( ocular hypertension ) does not increase perimetric contrast sensitivity .
METHODS	Comparative case series .
METHODS	A total of 692 participants drawn from the Ocular Hypertension Treatment Study ( OHTS ) ( 22 clinical centers ) .
METHODS	Commercially available topical ocular hypotensive medications .
METHODS	Post hoc analysis of IOP and perimetric contrast sensitivity ( mean deviation [ MD ] and pattern standard deviation [ PSD ] ) both at baseline ( 0 months , immediately before ocular antihypertensive therapy ) and at 6-month review .
METHODS	An additional 618 control eyes from OHTS that did not receive treatment were examined over the same period .
METHODS	Data from the second phase of OHTS also were examined , and control eyes then received treatment .
RESULTS	Treated eyes had a decrease in IOP at 6 months ( 5.1 mmHg , P < 0.001 ) but no significant change in MD ( 0.04 decibels [ dB ] , P = 0.59 ) or PSD ( 0.03 dB , P = 0.19 ) , relative to controls .
RESULTS	A similar decrease in IOP was found for eyes that began treatment in the second phase of OHTS , but no significant change in MD or PSD .
CONCLUSIONS	Despite using a large sample size , we found no relationship between perimetric contrast sensitivity and IOP reduction in ocular hypertension , which suggests that previous sensitivity changes seen in patients with glaucoma , if true , are indicative of reversible glaucoma-induced dysfunction rather than a general relationship between sensitivity and IOP in visual mechanisms unaffected by glaucoma .

###24566233
BACKGROUND	Utilization rates ( URs ) for implantable cardioverter-defibrillators ( ICDs ) for primary prevention of sudden cardiac death ( PPSCD ) are lacking in the community .
OBJECTIVE	The purpose of this study was to establish the ICD UR in central Indiana .
METHODS	A query run on 2 hospitals in a health information exchange database in Indianapolis identified patients between 2011 and 2012 with left ventricular ejection fraction ( EF ) 0.35 .
METHODS	ICD eligibility and utilization were determined from chart review .
RESULTS	We identified 1863 patients with at least 1 low EF study .
RESULTS	Two cohorts were analyzed : 1672 patients without and 191 patients with International Classification of Diseases , Ninth Revision , Clinical Modification procedure code 37.94 for ICD placement .
RESULTS	We manually reviewed a stratified ( by hospital ) random sample of 300 patients from the no-ICD procedure code cohort and found that 48 ( 16 % ) had no ICD but had class I indications for ICD .
RESULTS	Eight of 300 ( 2.7 % ) actually had ICD implantation for PPSCD .
RESULTS	Review of all 191 patients in the ICD procedure code cohort identified 70 with ICD implantation for PPSCD .
RESULTS	The ICD UR ( ratio between patients with ICD for PPSCD and all with indication ) was 38 % overall ( 95 % confidence interval [ CI ] 28 % -49 % ) .
RESULTS	URs were 48 % for males ( 95 % CI 34 % -61 % ) , 21 % for females ( 95 % CI 16 % -26 % , P = .0002 vs males ) , 40 % for whites ( 95 % CI 27 % -53 % ) , and 37 % for blacks ( 95 % CI 28 % -46 % , P = .66 vs whites ) .
CONCLUSIONS	ICD UR is 38 % among patients meeting class I indications , suggesting further opportunities for improving guideline compliance .
CONCLUSIONS	This study also illustrates limitations in calculating ICD UR using large electronic repositories without hands-on chart review .

###25215468
BACKGROUND	Diabetic foot wounds are a highly morbid and costly complication of diabetes mellitus .
BACKGROUND	Targeted amino acid supplementation , by increasing tissue hydroxyproline concentrations , has been implicated in improved wound outcomes in surgical incisions and chronic wounds , and after radiation injury .
BACKGROUND	A major component of collagen , hydroxyproline is a surrogate marker used commonly for tissue collagen concentrations .
BACKGROUND	This paper reviews the literature pertaining to amino acid supplementation and wound healing , and also evaluates our pilot data relating to supplementation with arginine , glutamine , and beta-hydroxy-beta-methylbutyrate ( HMB ) in the treatment of diabetic foot ulcers .
METHODS	For the pilot study , nine patients scheduled to undergo wound debridement for diabetic foot ulcers were randomized prospectively to be a part of either a placebo group or a treatment group that received supplementation twice daily for 2 wks .
METHODS	Tissue samples were collected both before and after 2 wk of supplementation .
METHODS	The results of assay of the samples for hydroyproline were then analyzed via a one tailed Student t-test to evaluate tissue concentrations of hydroxyproline .
METHODS	For the literature review in the study , the MEDLINE/PubMed database was reviewed , using search terms contained in the Medical Subject Headings ( MeSH ) .
RESULTS	The treatment group in the study exhibited a significantly greater hydroxyproline concentration after supplementation than before it ( p = 0.03 ) .
RESULTS	The mean percent change in the tissue hydroxyproline concentration for arginine , glutamine , and HMB group was +67.8 % , with a standard deviation ( SD ) of 129.89 .
RESULTS	The mean percent change for the corresponding amino acids in the placebo group was -78.4 % , with an SD of 20.55 .
RESULTS	The review of the MEDLINE/PubMed literature revealed only two human studies of amino acid supplementation in patients with diabetic foot wounds , one of which found a significant improvement in wound-depth and wound-appearance scores .
CONCLUSIONS	Given the results of our pilot study , and on the basis of a review of the literature , the administration of a simple amino acid supplement may improve the healing of diabetic foot wounds via increased collagen production .

###25614407
OBJECTIVE	Using a through-the-needle local anesthetic bolus technique , ultrasound-guided infraclavicular perineural catheters have been shown to provide greater analgesia compared to supraclavicular catheters .
OBJECTIVE	A through-the-catheter bolus technique , which arguably `` tests '' the anesthetic efficacy of the catheter before initiating an infusion , has been validated for infraclavicular catheters but not supraclavicular catheters .
OBJECTIVE	This study investigated the through-the-catheter bolus technique for supraclavicular catheters and tested the hypothesis that infraclavicular catheters provide faster onset of brachial plexus anesthesia .
METHODS	Preoperatively , patients were randomly assigned to receive either a supraclavicular or an infraclavicular catheter using an ultrasound-guided nonstimulating catheter insertion technique with a mepivacaine bolus via the catheter and ropivacaine perineural infusion initiated postoperatively .
METHODS	The primary outcome was time to achieve complete sensory anesthesia in the ulnar and median nerve distributions .
METHODS	Secondary outcomes included procedural time , procedure-related pain and complications , and postoperative pain , opioid consumption , sleep disturbances , and motor weakness .
RESULTS	Fifty patients were enrolled in the study ; all but 2 perineural catheters were successfully placed per protocol .
RESULTS	Twenty-one of 24 ( 88 % ) and 24 of 24 ( 100 % ) patients in the supraclavicular and infraclavicular groups , respectively , achieved complete sensory anesthesia by 30 minutes ( P = .088 ) .
RESULTS	There was no difference in the time to achieve complete sensory anesthesia .
RESULTS	Supraclavicular patients reported more sleep disturbances postoperatively , but there were no statistically significant differences in other outcomes .
CONCLUSIONS	Both supraclavicular and infraclavicular perineural catheters using a through-the-catheter bolus technique provide effective brachial plexus anesthesia .

###26088268
BACKGROUND	Idarucizumab is a monoclonal antibody fragment that binds dabigatran with high affinity in a 1:1 molar ratio .
BACKGROUND	We investigated the safety , tolerability , and efficacy of increasing doses of idarucizumab for the reversal of anticoagulant effects of dabigatran in a two-part phase 1 study ( rising-dose assessment and dose-finding , proof-of-concept investigation ) .
BACKGROUND	Here we present the results of the proof-of-concept part of the study .
METHODS	In this randomised , placebo-controlled , double-blind , proof-of-concept phase 1 study , we enrolled healthy volunteers ( aged 18-45 years ) with a body-mass index of 185-299 kg/m ( 2 ) into one of four dose groups at SGS Life Sciences Clinical Research Services , Belgium .
METHODS	Participants were randomly assigned within groups in a 3:1 ratio to idarucizumab or placebo using a pseudorandom number generator and a supplied seed number .
METHODS	Participants and care providers were masked to treatment assignment .
METHODS	All participants received oral dabigatran etexilate 220 mg twice daily for 3 days and a final dose on day 4 .
METHODS	Idarucizumab ( 1 g , 2 g , or 4 g 5-min infusion , or 5 g plus 25 g in two 5-min infusions given 1 h apart ) was administered about 2 h after the final dabigatran etexilate dose .
METHODS	The primary endpoint was incidence of drug-related adverse events , analysed in all randomly assigned participants who received at least one dose of dabigatran etexilate .
METHODS	Reversal of diluted thrombin time ( dTT ) , ecarin clotting time ( ECT ) , activated partial thromboplastin time ( aPTT ) , and thrombin time ( TT ) were secondary endpoints assessed by measuring the area under the effect curve from 2 h to 12 h ( AUEC2-12 ) after dabigatran etexilate ingestion on days 3 and 4 .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01688830 .
RESULTS	Between Feb 23 , and Nov 29 , 2013 , 47 men completed this part of the study .
RESULTS	12 were enrolled into each of the 1 g , 2 g , or 5 g plus 25 g idarucizumab groups ( nine to idarucizumab and three to placebo in each group ) , and 11 were enrolled into the 4 g idarucizumab group ( eight to idarucizumab and three to placebo ) .
RESULTS	Drug-related adverse events were all of mild intensity and reported in seven participants : one in the 1 g idarucizumab group ( infusion site erythema and hot flushes ) , one in the 5 g plus 25 g idarucizumab group ( epistaxis ) ; one receiving placebo ( infusion site haematoma ) , and four during dabigatran etexilate pretreatment ( three haematuria and one epistaxis ) .
RESULTS	Idarucizumab immediately and completely reversed dabigatran-induced anticoagulation in a dose-dependent manner ; the mean ratio of day 4 AUEC2-12 to day 3 AUEC2-12 for dTT was 101 with placebo , 026 with 1 g idarucizumab ( 74 % reduction ) , 006 with 2 g idarucizumab ( 94 % reduction ) , 002 with 4 g idarucizumab ( 98 % reduction ) , and 001 with 5 g plus 25 g idarucizumab ( 99 % reduction ) .
RESULTS	No serious or severe adverse events were reported , no adverse event led to discontinuation of treatment , and no clinically relevant difference in incidence of adverse events was noted between treatment groups .
CONCLUSIONS	These phase 1 results show that idarucizumab was associated with immediate , complete , and sustained reversal of dabigatran-induced anticoagulation in healthy men , and was well tolerated with no unexpected or clinically relevant safety concerns , supporting further testing .
CONCLUSIONS	Further clinical studies are in progress .
BACKGROUND	Boehringer Ingelheim Pharma GmbH & Co KG .

###24969283
BACKGROUND	Recent studies indicate that persistent intestinal inflammation in patients with Crohn 's disease ( CD ) might be caused by abnormal intestinal microbiota .
BACKGROUND	This hypothesis may suggest a beneficial effect of antibiotics in CD therapy .
BACKGROUND	So far , guidelines do not recommend antibiotics except in the treatment of complicated CD , and there are few studies on the effects of rifaximin in these patients .
METHODS	Between December 2011 and December 2012 , we performed a blinded randomized trial in 168 patients with a previous history of moderately active CD concerning the efficacy of rifaximin .
METHODS	All the patients had previously achieved remission with standard therapy ( prednisone/budesonide ) .
METHODS	Data from patients receiving 800 mg of rifaximin ( 83 patients ) twice a day for 12 weeks were compared with those from patients who received placebo ( 83 patients ) .
METHODS	The primary endpoint was maintaining remission during the follow-up .
RESULTS	All the patients ( 100 % ; 83/83 ) on 800 mg of rifaximin were in remission after 12 weeks of treatment in comparison with 84 % ( 70/83 ) of the placebo group .
RESULTS	This significant difference was also persistent at the 24-week follow-up [ 78 % ( 65/83 ) vs. 41 % ( 34/83 ) , respectively ] .
RESULTS	The last evaluation performed at 48 weeks revealed disease activity in 45 % ( 38/83 ) of the patients of the rifaximin group , i.e. a significant decrease compared with the placebo group [ 75 % ( 63 of 83 ) ] .
CONCLUSIONS	Remission previously obtained with standard treatment can be sustained in patients with moderately active CD after the administration of 800 mg of rifaximin .

###24835634
OBJECTIVE	It is well known that to acquire sensorimotor ( SMR ) - based brain-computer interface ( BCI ) control requires a training period before users can achieve their best possible performances .
OBJECTIVE	Nevertheless , the effect of this training procedure on the cortical activity related to the mental imagery ability still requires investigation to be fully elucidated .
OBJECTIVE	The aim of this study was to gain insights into the effects of SMR-based BCI training on the cortical spectral activity associated with the performance of different mental imagery tasks .
METHODS	Linear cortical estimation and statistical brain mapping techniques were applied on high-density EEG data acquired from 18 healthy participants performing three different mental imagery tasks .
METHODS	Subjects were divided in two groups , one of BCI trained subjects , according to their previous exposure ( at least six months before this study ) to motor imagery-based BCI training , and one of subjects who were naive to any BCI paradigms .
RESULTS	Cortical activation maps obtained for trained and naive subjects indicated different spectral and spatial activity patterns in response to the mental imagery tasks .
RESULTS	Long-term effects of the previous SMR-based BCI training were observed on the motor cortical spectral activity specific to the BCI trained motor imagery task ( simple hand movements ) and partially generalized to more complex motor imagery task ( playing tennis ) .
RESULTS	Differently , mental imagery with spatial attention and memory content could elicit recognizable cortical spectral activity even in subjects completely naive to ( BCI ) training .
CONCLUSIONS	The present findings contribute to our understanding of BCI technology usage and might be of relevance in those clinical conditions when training to master a BCI application is challenging or even not possible .

###24672937
OBJECTIVE	To observe the intervention effect of Leihong Granule ( LG ) in in-stent restenosis ( ISR ) after endovascular therapy for lower extremity arterial occlusive diseases ( LEAOD ) .
METHODS	Recruited 80 LEAOD patients who successfully underwent endovascular therapy ( balloon dilation and stent implantation ) were randomly assigned to two groups , the control group and the LG group , 40 in each group .
METHODS	Patients in the control group received basic treatment , while those in the LG group additionally took LG for 3 months .
METHODS	Plasma levels of IL-10 , IL-18 , CRP , and the intima-media thickness ( IMT ) of lower extremity artery were observed in the two groups between and after treatment .
METHODS	The rate of stent patency , ABI , intermittent claudication , rest pain , and the incidence of amputation the two groups were recorded and observed in the two groups .
RESULTS	In the control group , serum levels of IL-10 , IL-18 , CRP , and IMT were significantly higher one month after surgery than before surgery ( P < 0.05 ) .
RESULTS	There was no significant difference in serum levels of IL-10 , IL-18 , CRP , or IMT between the two groups before surgery ( P > 0.05 ) .
RESULTS	These indices were obviously lower in the LG group than in the control group after surgery ( P < 0.05 ) .
RESULTS	Compared with the control group , the incidence rates of intermittent claudication and the rest pain at 6 months and 12 months after surgery significantly decreased ( P < 0.05 ) .
RESULTS	The stent patency rate at 6 months and 12 months after surgery , and ABI were significantly higher than those of the control group ( P < 0.05 ) .
RESULTS	There was no statistical difference in the amputation rate between the two groups ( P > 0.05 ) .
CONCLUSIONS	LG might effectively improve ischemic symptoms of affected limbs possibly through lowering the ISR rate after endovascular therapy for LEAOD through preventing immunosuppressive actions .

###25236478
BACKGROUND	The aim of the study ; LCoMotion - Learning , Cognition and Motion was to develop , document , and evaluate a multi-component physical activity ( PA ) intervention in public schools in Denmark .
BACKGROUND	The primary outcome was cognitive function .
BACKGROUND	Secondary outcomes were academic skills , body composition , aerobic fitness and PA. .
BACKGROUND	The primary aim of the present paper was to describe the rationale , design and methods of the LCoMotion study .
METHODS	LCoMotion was designed as a cluster-randomized controlled study .
METHODS	Fourteen schools from all five regions in Denmark participated .
METHODS	All students from 6th and 7th grades were invited to participate ( n = 869 ) and consent was obtained for 87 % ( n = 759 ) .
METHODS	Baseline measurements were obtained in November/December 2013 and follow-up measurements in May/June 2014 .
METHODS	The intervention lasted five months and consisted of a `` package '' of three main components : PA during academic lessons , PA during recess and PA homework .
METHODS	Furthermore a cycling campaign was conducted during the intervention period .
METHODS	Intervention schools should endeavor to ensure that students were physically active for at least 60 min every school day .
METHODS	Cognitive function was measured by a modified Eriksen flanker task and academic skills by a custom made mathematics test .
METHODS	PA was objectively measured by accelerometers ( ActiGraph , GT3X and GT3X + ) and aerobic fitness assessed by an intermittent shuttle-run test ( the Andersen intermittent running test ) .
METHODS	Furthermore , compliance with the intervention was assessed by short message service ( SMS ) - tracking and questionnaires were delivered to students , parents and teachers .
CONCLUSIONS	LCoMotion has ability to provide new insights on the effectiveness of a multicomponent intervention on cognitive function and academic skills in 6th and 7th grade students .
BACKGROUND	Clinicaltrials.gov : NCT02012881 ( 10/10/2013 ) .

###24650926
BACKGROUND	Medication treatment decisions in heart failure ( HF ) are currently informed by measurements of brachial artery pressure , but ventricular afterload is more accurately represented by central aortic pressure , which differs from brachial pressure .
BACKGROUND	We sought to determine whether aggressive titration of vasoactive medicines beyond goal-directed heart failure medical therapy ( GDMT ) based upon aortic pressure improves exercise capacity and cardiovascular structure-function .
RESULTS	Subjects with chronic HF ( n = 50 ) underwent cardiopulmonary exercise testing , echocardiography , and arterial tonometry to measure aortic pressure and augmentation index , and were then randomized to aortic pressure-guided treatment ( active , n = 23 ) or conventional therapy ( control , n = 27 ) .
RESULTS	Subjects returned for 6 monthly visits wherein GDMT was first optimized .
RESULTS	Additional vasoactive therapies were then sequentially added with the goal to reduce aortic augmentation index to 0 % ( active ) or if brachial pressure remained elevated ( control ) .
RESULTS	Subjects randomized to active treatment experienced greater improvement in peak oxygen consumption compared with controls ( 1.373.76 versus -0.652.21 mL min ( -1 ) kg ( -1 ) , P = 0.025 ) though reductions in aortic augmentation index were similar ( -79 % versus -56 % , P = 0.46 ) .
RESULTS	Forward stroke volume increased while arterial elastance and left ventricular volumes decreased in all participants , with no between-group difference .
RESULTS	Subjects randomized to active treatment were more likely to receive additional vasoactive therapies including nitrates , aldosterone antagonists and hydralazine , with no increased risk of hypotension or worsening renal function .
CONCLUSIONS	Maximization of goal-directed medical therapy in heart failure patients may enhance afterload reduction and lead to reverse remodeling , while additional medicine titration based upon aortic pressure data improves exercise capacity in patients with heart failure .

###24937305
BACKGROUND	Haemorrhage is a common cause of death in trauma patients .
BACKGROUND	Although transfusions are extensively used in the care of bleeding trauma patients , there is uncertainty about the balance of risks and benefits and how this balance depends on the baseline risk of death .
BACKGROUND	Our objective was to evaluate the association of red blood cell ( RBC ) transfusion with mortality according to the predicted risk of death .
RESULTS	A secondary analysis of the CRASH-2 trial ( which originally evaluated the effect of tranexamic acid on mortality in trauma patients ) was conducted .
RESULTS	The trial included 20,127 trauma patients with significant bleeding from 274 hospitals in 40 countries .
RESULTS	We evaluated the association of RBC transfusion with mortality in four strata of predicted risk of death : < 6 % , 6 % -20 % , 21 % -50 % , and > 50 % .
RESULTS	For this analysis the exposure considered was RBC transfusion , and the main outcome was death from all causes at 28 days .
RESULTS	A total of 10,227 patients ( 50.8 % ) received at least one transfusion .
RESULTS	We found strong evidence that the association of transfusion with all-cause mortality varied according to the predicted risk of death ( p-value for interaction < 0.0001 ) .
RESULTS	Transfusion was associated with an increase in all-cause mortality among patients with < 6 % and 6 % -20 % predicted risk of death ( odds ratio [ OR ] 5.40 , 95 % CI 4.08-7 .13 , p < 0.0001 , and OR 2.31 , 95 % CI 1.96-2 .73 , p < 0.0001 , respectively ) , but with a decrease in all-cause mortality in patients with > 50 % predicted risk of death ( OR 0.59 , 95 % CI 0.47-0 .74 , p < 0.0001 ) .
RESULTS	Transfusion was associated with an increase in fatal and non-fatal vascular events ( OR 2.58 , 95 % CI 2.05-3 .24 , p < 0.0001 ) .
RESULTS	The risk associated with RBC transfusion was significantly increased for all the predicted risk of death categories , but the relative increase was higher for those with the lowest ( < 6 % ) predicted risk of death ( p-value for interaction < 0.0001 ) .
RESULTS	As this was an observational study , the results could have been affected by different types of confounding .
RESULTS	In addition , we could not consider haemoglobin in our analysis .
RESULTS	In sensitivity analyses , excluding patients who died early ; conducting propensity score analysis adjusting by use of platelets , fresh frozen plasma , and cryoprecipitate ; and adjusting for country produced results that were similar .
CONCLUSIONS	The association of transfusion with all-cause mortality appears to vary according to the predicted risk of death .
CONCLUSIONS	Transfusion may reduce mortality in patients at high risk of death but increase mortality in those at low risk .
CONCLUSIONS	The effect of transfusion in low-risk patients should be further tested in a randomised trial .
BACKGROUND	www.ClinicalTrials.gov NCT01746953 .

###24877167
BACKGROUND	The objective of this trial was to determine how a mucoadhesive hydrogel ( MuGard ) , a marketed medical device , would fare when tested with the strictness of a conventional multi-institutional , double-blind , randomized , placebo-controlled study format .
METHODS	A total of 120 subjects planned to receive chemoradiation therapy ( CRT ) for treatment of head and neck cancers were randomized to receive either MuGard or sham control rinse ( SC ) during CRT .
METHODS	Subjects completed the validated Oral Mucositis Daily Questionnaire .
METHODS	Weight , opiate use , and World Health Organization ( WHO ) oral mucositis ( OM ) scores were recorded .
METHODS	Subjects who dosed at least once daily during the first 2.5 weeks of CRT were included in the efficacy analysis .
RESULTS	Of 120 subjects enrolled , 78 ( SC , N = 41 ; MuGard , N = 37 ) were eligible for efficacy analysis .
RESULTS	Both cohorts were similar in demographics , baseline characteristics , primary tumor type , and planned CRT regimen .
RESULTS	MuGard effectively mitigated OM symptoms as reflected by area under the curve of daily patient-reported oral soreness ( P = .034 ) and WHO scores on the last day of radiation therapy ( P = .038 ) .
RESULTS	MuGard was also associated with nonsignificant trends related to therapeutic benefit including opioid use duration , and OM scores ( WHO criteria ) at CRT week 4 .
RESULTS	Rinse compliance was identical between cohorts .
RESULTS	No significant adverse events were reported , and the adverse event incidence was similar between cohorts .
CONCLUSIONS	Testing MuGard , a rinse marketed as a device , in a standard clinical trial format demonstrated its superiority to SC in mitigating OM symptoms , delaying OM progression , and its safety and tolerability .

###24452673
BACKGROUND	The European Organization for Research and Treatment of Cancer ( EORTC ) 24954 phase 3 randomized clinical trial compared 2 schemes of combined chemotherapy for patients with resectable cancers of the hypopharynx and larynx : sequential induction chemotherapy and radiotherapy versus alternating chemoradiotherapy .
BACKGROUND	The current study reports detailed effects of both treatment arms on health-related quality of life ( HRQOL ) and symptoms .
METHODS	A total of 450 patients aged 35 years to 76 years ( World Health Organization performance status ( WHO PS ) 2 ) with untreated , resectable advanced squamous cell carcinoma of the larynx ( tumor classification of T3-T4 ) or hypopharynx ( tumor classification of T2-T3-T4 ) with regional lymph nodes in the neck classified as N0 to N2 with no metastases were randomized in this prospective phase 3 trial into either the sequential arm ( control ) or the alternating arm ( experimental ) .
METHODS	QOL assessment was performed at randomization ; at baseline ; at 42 days ; and at 6 , 12 , 24 , 36 , and 48 months .
RESULTS	There were no observed differences with regard to the primary endpoint of Fatigue and secondary endpoint of Dyspnea .
RESULTS	Significant differences were found in the secondary endpoints of Swallowing and Speech problems at 42 days after randomization in favor of patients in the sequential arm .
RESULTS	Explanatory and sensitivity analysis revealed that the primary analysis favored the sequential arm , but the majority of differences in HRQOL did not exist at the end of treatment , and returned to baseline levels .
CONCLUSIONS	In the current study , a trend toward worse scores was noted in the patients treated on the alternating chemoradiotherapy arm but very few differences reached the level of statistical significance .
CONCLUSIONS	The HRQOL scores of the majority of patients returned to baseline after therapy .

###24355994
OBJECTIVE	This study sought to establish the efficacy of single-lead , 3-wk peripheral nerve stimulation ( PNS ) therapy for pain reduction in stroke survivors with chronic hemiplegic shoulder pain .
METHODS	This study is a single-site , pilot , randomized controlled trial of adults with chronic shoulder pain after stroke .
METHODS	Participants were randomized to receive a 3-wk treatment of single-lead PNS or usual care .
METHODS	The primary outcome was the worst pain in the last week ( Brief Pain Inventory , Short Form , question 3 ) measured at baseline and weeks 1 , 4 , 12 , and 16 .
METHODS	The secondary outcomes included pain interference ( Brief Pain Inventory , Short Form , question 9 ) , pain measured by the ShoulderQ Visual Graphic Rating Scales , and health-related quality-of-life ( Short-Form 36 version 2 ) .
RESULTS	Twenty-five participants were recruited , 13 to PNS and 12 to usual care .
RESULTS	There was a significantly greater reduction in pain for the PNS group compared with the controls , with significant differences at 6 and 12 wks after treatment .
RESULTS	Both PNS and usual care were associated with significant improvements in pain interference and physical health-related quality-of-life .
CONCLUSIONS	Short-term PNS is a safe and efficacious treatment of shoulder pain .
CONCLUSIONS	Pain reduction is greater compared with usual care and is maintained for at least 12 wks after treatment .

###25143497
BACKGROUND	When a surgeon uses a percutaneous volar approach to treat scaphoid waist fractures , central screw placement is complicated by the shape of the scaphoid and by obstruction by the trapezium .
BACKGROUND	In this study , we used radiographs and biomechanical tests to compare the standard volar percutaneous approach with the transtrapezial approach , with regard to central screw placement at the distal pole of the scaphoid .
METHODS	Fourteen matched pairs of cadaveric wrists were randomly assigned to two treatment groups .
METHODS	Under fluoroscopic control , a guidewire was drilled into the scaphoid , either through a transtrapezial approach or through a standard volar approach that avoided the trapezium .
METHODS	Guidewire position was measured in the coronal and sagittal planes .
METHODS	A transverse osteotomy was performed along the scaphoid waist , and this was followed by the insertion of the longest possible cannulated headless bone screw .
METHODS	Each specimen was placed into a fixture with a pneumatically driven plunger resting on the surface of the distal pole .
METHODS	Load was applied by using a load-controlled test protocol in a hydraulic testing machine .
RESULTS	All guidewires were inside the central one-third of the proximal pole .
RESULTS	The guidewire positions at the distal pole differed significantly between the transtrapezial and standard volar approach groups ( p < 0.001 ) .
RESULTS	The load to 2 mm of displacement and the load to failure averaged , respectively , 324.4 N ( standard error of the mean [ SEM ] = 73.5 N ) and 386.4 N ( SEM = 65.6 N ) for the transtrapezial approach group compared with 125.7 N ( SEM = 22.6 N ) ( p = 0.002 ) and 191.4 N ( SEM = 36.30 N ) ( p = 0.005 ) for the standard volar approach group .
CONCLUSIONS	The data suggest that , in a cadaveric osteotomy-simulated scaphoid waist fracture model , the transtrapezial approach reliably achieves central positioning of a screw in the proximal and distal poles .
CONCLUSIONS	This position offers a biomechanical advantage compared with central placement in only the proximal pole .

###24815999
BACKGROUND	The characteristics of each inhalation maneuver when patients use dry powder inhalers ( DPIs ) are important , because they control the quality of the emitted dose .
METHODS	We have measured the inhalation profiles of asthmatic children [ CHILD ; n = 16 , mean forced expiratory volume in 1sec ( FEV1 ) 79 % predicted ] , asthmatic adults ( ADULT ; n = 53 , mean predicted FEV1 72 % ) , and chronic obstructive pulmonary disease ( COPD ; n = 29 , mean predicted FEV1 42 % ) patients when they inhaled through an Aerolizer , Diskus , Turbuhaler , and Easyhaler using their `` real-life '' DPI inhalation technique .
METHODS	These are low - , medium - , medium/high - , and high-resistance DPIs , respectively .
METHODS	The inhalation flow against time was recorded to provide the peak inhalation flow ( PIF ; in L/min ) , the maximum pressure change ( P ; in kPa ) , acceleration rates ( ACCEL ; in kPa/sec ) , time to maximum inhalation , the length of each inhalation ( in sec ) , and the inhalation volume ( IV ; in liters ) of each inhalation maneuver .
RESULTS	PIF , P , and ACCEL values were consistent with the order of the inhaler 's resistance .
RESULTS	For each device , the inhalation characteristics were in the order ADULT > COPD > CHILD for PIF , P , and ACCEL ( p < 0.001 ) .
RESULTS	The results showed a large variability in inhalation characteristics and demonstrate the advantages of P and ACCEL rather than PIFs .
RESULTS	Overall inhaled volumes were low , and only one patient achieved an IV > 4L and P > 4kPa .
CONCLUSIONS	The large variability of these inhalation characteristics and their range highlights that if inhalation profiles were used with compendial in vitro dose emission measurements , then the results would provide useful information about the dose patients inhale during routine use .
CONCLUSIONS	The inhalation characteristics highlight that adults with asthma have greater inspiratory capacity than patients with COPD , whereas children with asthma have the lowest .
CONCLUSIONS	The significance of the inhaled volume to empty doses from each device requires investigation .

###25031274
BACKGROUND	Median survival of non-small cell lung cancer ( NSCLC ) patients with brain metastases is poor .
BACKGROUND	We examined concurrent erlotinib and whole brain radiotherapy ( WBRT ) followed by maintenance erlotinib in patients with untreated brain metastases , given the potential radiosensitizing properties of erlotinib and its direct effect on brain metastases and systemic activity .
METHODS	Eighty NSCLC patients with KPS of 70 and greater and multiple brain metastases were randomly assigned to placebo ( n = 40 ) or erlotinib ( 100mg , n = 40 ) given concurrently with WBRT ( 20 Gy in 5 fractions ) .
METHODS	Following WBRT , patients continued with placebo or erlotinib ( 150 mg ) until disease progression .
METHODS	The primary end point was neurological progression-free survival ( nPFS ) ; hazard ratios ( HRs ) were calculated using Cox regression .
METHODS	All P values were two-sided .
RESULTS	Fifteen patients ( 37.5 % ) from each arm were alive and without neurological progression 2 months after WBRT .
RESULTS	Median nPFS was 1.6 months in both arms ; nPFS HR 0.95 ( 95 % CI = 0.59 to 1.54 ; P = .84 ) .
RESULTS	Median overall survival ( OS ) was 2.9 and 3.4 months in the placebo and erlotinib arms ; HR 0.95 ( 95 % CI = 0.58 to 1.55 ; P = .83 ) .
RESULTS	The frequency of epidermal growth factor receptor ( EGFR ) mutations was low with only 1 of 35 ( 2.9 % ) patients with available samples had activating EGFR-mutations .
RESULTS	Grade 3/4 adverse event rates were similar between the two groups ( 70.0 % in each arm ) , except for rash 20.0 % ( erlotinib ) vs 5.0 % ( placebo ) , and fatigue 17.5 % vs 35.0 % .
RESULTS	No statistically significant quality of life differences were found .
CONCLUSIONS	Our study showed no advantage in nPFS or OS for concurrent erlotinib and WBRT followed by maintenance erlotinib in patients with predominantly EGFR wild-type NSCLC and multiple brain metastases compared to placebo .
CONCLUSIONS	Future studies should focus on the role of erlotinib with or without WBRT in patients with EGFR mutations .

###24472398
OBJECTIVE	Osmotic-controlled release oral delivery system ( OROS ) hydromorphone - an extended-release preparation - is recommended long-term therapy for chronic pain patients .
OBJECTIVE	Dose proportionality of OROS hydromorphone has been shown in healthy Caucasian volunteers ; however , no studies have been conducted in Asian populations .
OBJECTIVE	To determine whether ethnic differences affect the drug 's pharmacokinetic ( PK ) profile , we evaluated the dose proportionality of OROS hydromorphone in healthy Taiwanese adults .
METHODS	This 12-week , open-label , 4-way crossover , phase 1 study randomly assigned subjects to 1 of 4 treatment sequences - single oral dose OROS hydromorphone : 8 mg , 16 mg , 32 mg , or 64 mg - along with 50 mg naltrexone .
METHODS	Dose proportionality was assessed using a linear mixed-effects model to estimate the slope of the regression line and its 90 % CI for Cmax , AUC0-48h , and AUClast .
METHODS	Descriptive statistics measured plasma hydromorphone concentrations , PK parameters , laboratory analytes , and vital signs .
RESULTS	23 subjects completed the study ; a single-dose of OROS hydromorphone increased plasma concentration steadily for 6 hours and sustained it at or near maximum levels for ~ 24 hours .
RESULTS	After dose normalization to a 16 mg dose , all studied doses demonstrated dose proportionality for Cmax , AUClast , and AUC0-48h , as the slopes of the regression lines for Cmax , AUClast , and AUC0-48h were close to zero , and the 90 % CIs within pre-specified limits .
RESULTS	Adverse events were as expected for hydromorphone administered with concomitant naltrexone .
CONCLUSIONS	Single doses of 8 mg , 16 mg , 32 mg , and 64 mg of OROS hydromorphone were found to be dose proportional for Cmax , AUClast , and AUC0-48h and were generally safe and well-tolerated in healthy Taiwanese adults .

###25196117
BACKGROUND	Treatment with inhaled glucocorticoids in combination with long-acting bronchodilators is recommended in patients with frequent exacerbations of severe chronic obstructive pulmonary disease ( COPD ) .
BACKGROUND	However , the benefit of inhaled glucocorticoids in addition to two long-acting bronchodilators has not been fully explored .
METHODS	In this 12-month , double-blind , parallel-group study , 2485 patients with a history of exacerbation of COPD received triple therapy consisting of tiotropium ( at a dose of 18 g once daily ) , salmeterol ( 50 g twice daily ) , and the inhaled glucocorticoid fluticasone propionate ( 500 g twice daily ) during a 6-week run-in period .
METHODS	Patients were then randomly assigned to continued triple therapy or withdrawal of fluticasone in three steps over a 12-week period .
METHODS	The primary end point was the time to the first moderate or severe COPD exacerbation .
METHODS	Spirometric findings , health status , and dyspnea were also monitored .
RESULTS	As compared with continued glucocorticoid use , glucocorticoid withdrawal met the prespecified noninferiority criterion of 1.20 for the upper limit of the 95 % confidence interval ( CI ) with respect to the first moderate or severe COPD exacerbation ( hazard ratio , 1.06 ; 95 % CI , 0.94 to 1.19 ) .
RESULTS	At week 18 , when glucocorticoid withdrawal was complete , the adjusted mean reduction from baseline in the trough forced expiratory volume in 1 second was 38 ml greater in the glucocorticoid-withdrawal group than in the glucocorticoid-continuation group ( P < 0.001 ) ; a similar between-group difference ( 43 ml ) was seen at week 52 ( P = 0.001 ) .
RESULTS	No change in dyspnea and minor changes in health status occurred in the glucocorticoid-withdrawal group .
CONCLUSIONS	In patients with severe COPD receiving tiotropium plus salmeterol , the risk of moderate or severe exacerbations was similar among those who discontinued inhaled glucocorticoids and those who continued glucocorticoid therapy .
CONCLUSIONS	However , there was a greater decrease in lung function during the final step of glucocorticoid withdrawal .
CONCLUSIONS	( Funded by Boehringer Ingelheim Pharma ; WISDOM ClinicalTrials.gov number , NCT00975195 . )

###24693625
OBJECTIVE	To evaluate the anti-gingivitis benefits of a 0.454 % highly bioavailable stannous fluoride dentifrice ( SnF2 ) relative to a 0.3 % triclosan/copolymer dentifrice ( triclosan/copolymer ) among triclosan/copolymer dentifrice users with residual gingivitis .
METHODS	This was a randomized , controlled , double-blind , parallel group , 2-month clinical study .
METHODS	Self-reported triclosan/copolymer dentifrice users were recruited and provided with triclosan/copolymer dentifrice to use for 1 month .
METHODS	After this 1-month acclimation period , subjects who had residual gingivitis at the baseline visit were randomized to either the SnF2 dentifrice or the triclosan/copolymer dentifrice ( positive control ) .
METHODS	Subjects performed their treatment unsupervised using their assigned dentifrice following manufacturers ' usage instructions for 2 months .
METHODS	The Gingival Bleeding Index ( GBI ) and Modified Gingival Index ( MGI ) were used to measure gingivitis benefits at baseline and Month 2 .
METHODS	An analysis of covariance was performed to compare treatment groups for the post-baseline scores as well as change from baseline , with the baseline score as a covariate .
METHODS	All comparisons were two-sided at the 0.05 level of significance .
RESULTS	A total of 150 subjects were randomized to treatment .
RESULTS	Both treatment groups experienced significant reductions in number of bleeding sites , gingival bleeding index ( GBI ) , and gingival inflammation ( MGI ) relative to baseline ( P < 0.001 ) .
RESULTS	At Month 2 , the SnF2 dentifrice group demonstrated significantly lower adjusted mean scores versus the triclosan/copolymer group for number of bleeding sites , GBI , and MGI ( P < 0.001 ) .
RESULTS	Between-treatment group comparisons for change from baseline values showed that the improvement in number of bleeding sites from baseline for the SnF2 group was 49 % greater versus that of the triclosan/copolymer group ( P < 0.001 ) , and the GBI and MGI improvements from baseline for the SnF2 group were 48 % and 37 % , greater , respectively , relative to the triclosan/copolymer group ( P < 0.001 ) .

###24317854
OBJECTIVE	To compare two different vitrification methods to slow freezing method for cryopreservation of human cleavage stage embryos .
METHODS	Prospective randomised trial .
METHODS	University assisted reproduction centre .
METHODS	568 patients ( mean age 33.4 5.2 ) from April 2009 to April 2011 .
METHODS	1798 supernumerary good-quality cleavage stage embryos in 645 IVF cycles intended to be cryopreserved were randomly allocated to three groups : slow freezing , vitrification with the Irvine method , vitrification with the Vitrolife method .
METHODS	Embryo survival and cleavage rates , implantation rate .
RESULTS	A total of 1055 embryos were warmed , 836 ( 79.2 % ) survived and 676 were finally transferred ( 64.1 % ) .
RESULTS	Post-warming embryos survival rate was significantly higher after vitrification ( Irvine : 89.4 % ; Vitrolife : 87.6 % ) than after slow freezing ( 63.8 % ) ( p < 0.001 ) .
RESULTS	No differences in survival rates were observed between the two vitrification methods , but a significant higher cleavage rate was observed using Irvine compared to Vitrolife method ( p < 0.05 ) .
RESULTS	Implantation rate ( IR ) per embryo replaced and per embryo warmed were respectively 15.8 % ( 41/259 ) and 12.4 % ( 41/330 ) for Irvine , 17.0 % ( 40/235 ) and 12.1 % ( 40/330 ) for Vitrolife , 21.4 % ( 39/182 ) and 9.9 % ( 39/395 ) for slow-freezing ( NS ) .
CONCLUSIONS	Both vitrification methods ( Irvine and Vitrolife ) are more efficient than slow freezing for cryopreservation of human cleavage stage embryos in terms of post-warming survival rate .
CONCLUSIONS	No significant difference in the implantation rate was observed between the three cryopreservation methods .

###24507766
OBJECTIVE	To evaluate rectal dose and post-treatment patient-reported bowel quality of life ( QOL ) following radiation therapy for prostate cancer .
METHODS	Patient-reported QOL was measured at baseline and 2-years via the expanded prostate cancer index composite ( EPIC ) for 90 patients .
METHODS	Linear regression modeling was performed using the baseline score for the QUANTEC normal tissue complication probability model and dose volume histogram ( DVH ) parameters for the whole and segmented rectum ( superior , middle , and inferior ) .
RESULTS	At 2-years the mean summary score declined from a baseline of 96.0-91 .8 .
RESULTS	The median volume of rectum treated to 70 Gy ( V70 ) was 11.7 % for the whole rectum and 7.0 % , 24.4 % , and 1.3 % for the inferior , middle , and superior rectum , respectively .
RESULTS	Mean dose to the whole and inferior rectum correlated with declines in bowel QOL while dose to the mid and superior rectum did not .
RESULTS	Low ( V25-V40 ) , intermediate ( V50-V60 ) and high ( V70-V80 ) doses to the inferior rectum influenced bleeding , incontinence , urgency , and overall bowel problems .
RESULTS	Only the highest dose ( V80 ) to the mid-rectum correlated with rectal bleeding and overall bowel problems .
CONCLUSIONS	Segmental DVH analysis of the rectum reveals associations between bowel QOL and inferior rectal dose that could significantly influence radiation planning and prognostic models .

###25439429
OBJECTIVE	To evaluate the effect of intravitreal aflibercept injection on visual function in wet age-related macular degeneration ( AMD ) .
METHODS	Prospective , multicenter , double-masked , active-controlled , parallel-group , randomized phase 3 clinical studies ( VEGF Trap-Eye : Investigation of Efficacy and Safety in Wet AMD [ VIEW ] 1 and 2 [ clinicaltrials.gov identifiers , NCT00509795 and NCT00637377 , respectively ] ) .
METHODS	Patients ( n = 2419 ) with active , treatment-nave , exudative AMD .
METHODS	This analysis included patients who received intravitreal aflibercept 2.0 mg every 8 weeks ( 2q8 ; n = 607 ) or ranibizumab 0.5 mg every 4 weeks ( 0.5 q4 ; n = 595 ) .
METHODS	Patients were randomized 1:1:1:1 to receive intravitreal aflibercept 2q8 ( after 3 initial monthly doses ) , intravitreal aflibercept 2q4 , intravitreal aflibercept 0.5 q4 , or ranibizumab 0.5 q4 in the study eye .
METHODS	Patients in the intravitreal aflibercept 2q8 group received a sham injection alternating with active treatment .
METHODS	The 25-item National Eye Institute Visual Function Questionnaire ( NEI VFQ-25 ) was administered at baseline and at weeks 12 , 24 , 36 , and 52 .
METHODS	The NEI VFQ-25 subscale scores were compared between intravitreal aflibercept 2q8 and ranibizumab 0.5 q4 treatment arms , the approved dosing for each agent worldwide .
METHODS	Change in composite NEI VFQ-25 score was evaluated based on categorical change in visual acuity ( worsened , unchanged , improved ) .
RESULTS	Baseline NEI VFQ-25 scores were similar for both treatments in both studies .
RESULTS	Mean change from baseline to 52 weeks was similar for ranibizumab 0.5 q4 and intravitreal aflibercept 2q8 across all 12 subscales , with the greatest improvements noted for mental health and general vision ( 9.0-11 .6 points , both treatments , both studies ) .
RESULTS	Improvement of 4 points or more ( both treatments , both studies ) also was observed for subscales near vision , distance vision , role difficulties , and dependency .
RESULTS	Mean change from baseline to 52 weeks in NEI VFQ-25 composite score ( pooled data ) stratified by clinical response showed meaningful improvement only in patients who gained 5 Early Treatment Diabetic Retinopathy letters or more ( 7.3 and 7.8 points for intravitreal aflibercept 2q8 and ranibizumab 0.5 q4 , respectively ) .
CONCLUSIONS	Visual function outcomes were similar across all NEI VFQ-25 subscales over 52 weeks for intravitreal aflibercept 2q8 and ranibizumab 0.5 q4 , with clinically meaningful improvement recorded in 6 of 12 subscales .

###26399101
OBJECTIVE	To evaluate the effect of length of tibial stump on proprioceptive recovery after anterior cruciate ligament ( ACL ) reconstruction .
METHODS	From March 2011 to December 2011,42 patients with ACL tear were performed with reconstruction .
METHODS	The patients were divided randomly into three groups : group A , the patients with remained length of tibial stump ranging from 15 to 20 mm , including 8 males and 6 females , with an average age of ( 28.2 6.6 ) years old ; group B , the patients with remained length of tibial stump ranging from 5 to 10 mm , including 9 males and 5 females , with an average age of ( 27.9 6.4 ) years old ; group C , the patients with remained length of tibial stump less than 2 mm , including 9 males and 5 females , with an average age of ( 28.6 6.8 ) years , old .
METHODS	The stability of knee were assessed by Lanchman test and anterior drawer test .
METHODS	The function of knee was assessed by Lysholm score and Tegner activity rating .
METHODS	The proprioceptive recovery was evaluated by assessing the passive reproduction of the angles with limb movement into flexion and extension in no weight bearing position .
RESULTS	Lanchman test and anterior drawer test of all patients were negative at 6 months postoperatively. , and there was one case of positive outcome in each group at 12 month and 18 month postoperatively .
RESULTS	Lysholm score and Tegner activity score of all patients at 18 month postoperatively were significantly better than that preoperatively , and there were no significant difference among three groups at 18 month postoperatively .
RESULTS	There were no significant difference in the production of the angles at flexion to 20 and extention to 80 and 20 among these groups before and after operation .
RESULTS	The reproduction of the angles of group A and B at flexion to 50 and extention to 50 at 6 month postoperatively were significantly better than that of group A and B preoperatively and that of group C at 6 month postoperatively , and there were no significant difference among three groups at 18 month postoperatively .
RESULTS	The reproduction of the angles of group A and B at flexion to 80 at 12 month postoperatively were significantly better than that of group A and B preoperatively and that of group C at 12 month postoperatively , and there were no significant difference among three groups at 18 month postoperatively .
CONCLUSIONS	Preservation of tibial stump in ACL reconstruction has benefit in proprioceptive recovery at early stage postoperatively and the length of tibial stump should be reserved with a range from 5 to 10 mm .

###24910934
OBJECTIVE	To determine whether a single treatment of botulinum toxin A in the forehead ( glabellar ) region can improve symptoms of depression in patients with major depressive disorder ( MDD ) , as defined by DSM-IV criteria .
METHODS	Thirty participants were randomly assigned to receive either placebo or botulinum toxin A ( BTA ; onabotulinumtoxinA ) injections in the forehead .
METHODS	Female participants received 29 units ; male participants received 39 units .
METHODS	At week 12 , the groups were crossed over .
METHODS	Participants were evaluated at weeks 0 , 3 , 6 , 12 , 15 , 18 , and 24 for improvement in MDD symptoms using the Patient Health Care Questionnaire-9 , Beck Depression Inventory ( BDI ) , and 21-Item Hamilton Depression Rating Scale ( HDRS-21 ) objective measurement scales .
METHODS	The primary outcome was the rate of HDRS-21 response , defined as 50 % score reduction from baseline .
METHODS	The study occurred from July 2011 to November 2012 .
RESULTS	Patients who received BTA at week 0 ( BTA-first group ) and at week 12 ( BTA-second group ) had a statistically significant reduction in MDD symptoms as compared to placebo .
RESULTS	Improvement in MDD continued over 24 weeks in the group that received BTA first even though the cosmetic effects of BTA wore off at 12 to 16 weeks .
RESULTS	HDRS-21 response rates were 55 % ( 6/11 ) in the BTA-first group , 24 % ( 4/17 ) in the BTA-second group , and 0 % ( 0/19 ) in the placebo group ( P < .0001 ) .
RESULTS	HDRS-21 remission rates ( score 7 ) were 18 % ( 2/11 ) , 18 % ( 3/17 ) , and 0 % ( 0/19 ) , respectively ( P = .057 ) .
RESULTS	HDRS-21 scores dropped -46 % and -35 % in the BTA-first and - second groups versus -2 % in the placebo group ( P < .0001 ) .
RESULTS	The BDI response rate ( 50 % reduction from baseline ) was 45 % ( 5/11 ) in the BTA-first group , 33 % ( 6/18 ) in the BTA-second group , and 5 % ( 1/19 ) in the placebo group ( P = .0067 ) .
RESULTS	BDI remission rates ( score 9 ) were 27 % ( 3/11 ) , 33 % ( 6/18 ) , and 5 % ( 1/19 ) , respectively ( P = .09 ) .
RESULTS	BDI scores dropped -42 % and -35 % in the BTA-first and - second groups versus -15 % in the placebo group ( P < .0001 ) .
CONCLUSIONS	Botulinum toxin A injection in the glabellar region was associated with significant improvement in depressive symptoms and may be a safe and sustainable intervention in the treatment of MDD .
BACKGROUND	ClinicalTrials.gov identifier : NCT01392963 .

###25272149
OBJECTIVE	To compare 2 omega-3 ( n-3 ) preparations enriched with eicosapentaenoic acid ( EPA ) versus docosahexaenoic acid ( DHA ) as monotherapy for major depressive disorder ( MDD ) in a 2-site , placebo-controlled , randomized , double-blind clinical trial .
METHODS	196 adults ( 53 % female ; mean [ SD ] age = 44.7 [ 13.4 ] years ) with DSM-IV MDD and a baseline 17-item Hamilton Depression Rating Scale ( HDRS-17 ) score 15 were randomized equally from May 18 , 2006 , to June 30 , 2011 , to 8 weeks of double-blind treatment with oral EPA-enriched n-3 1000 mg/d , DHA-enriched n-3 1,000 mg/d , or placebo .
RESULTS	154 subjects completed the study .
RESULTS	Modified intent-to-treat ( mITT ) analysis ( n = 177 subjects with 1 postbaseline visit ; 59.3 % female , mean [ SD ] age 45.8 [ 12.5 ] years ) employed mixed-model repeated measures ( MMRM ) .
RESULTS	All 3 groups demonstrated statistically significant improvement in the HDRS-17 ( primary outcome measure ) , 16-item Quick Inventory of Depressive Symptomatology-Self Report ( QIDS-SR-16 ) , and Clinical Global Improvement-Severity Scale ( CGI-S ) ( P < .05 ) , but neither n-3 preparation separated from placebo ( P > .05 ) .
RESULTS	Response and remission rates were in the range of 40 % -50 % and 30 % , respectively , for all treatments , with no significant differences between groups .
RESULTS	One subject receiving EPA-enriched n-3 discontinued due to worsening depression , and 1 subject receiving placebo discontinued due to an unspecified `` negative reaction '' to pills .
CONCLUSIONS	Neither EPA-enriched nor DHA-enriched n-3 was superior to placebo for the treatment of MDD .
BACKGROUND	ClinicalTrials.gov identifier : NCT00517036 .

###25080037
OBJECTIVE	To compare the 3-year stability , survival , and tolerability of 2 osseointegrated implants for bone conduction hearing : a wide 4.5-mm-diameter moderately roughened implant with a rounded 6-mm abutment ( test ) and a 3.75-mm diameter as-machined implant with a conically shaped 5.5-mm abutment ( control ) .
METHODS	In this randomized , prospective , controlled , multicenter clinical study , 77 adult patients were included .
METHODS	Test and control implants were randomly assigned in proportions of 2:1 .
METHODS	The implants were loaded with the sound processor from 6 weeks postimplantation .
METHODS	Follow-up after surgery was conducted at 10 days ; at 4 , 6 , 8 , and 12 weeks ; and at 6 , 12 , 24 , and 36 months after surgery .
METHODS	At every visit , implant stability quotient ( ISQ ) values were recorded by means of resonance frequency analysis ( RFA ) , and skin reactions were evaluated according to Holgers ' classification .
RESULTS	Statistically significantly higher mean ISQ values were recorded for the test implant compared with the control implant at each evaluation time point .
RESULTS	Between 2 and 3 years after surgery , ISQ values decreased but remained above baseline values .
RESULTS	Implant survival was high for both implants : 96.2 % of the test implants and 100 % of the control implants survived these 3 years .
RESULTS	Statistically significantly improved soft tissue outcomes were observed in the test implant group .
CONCLUSIONS	This extensive long-term clinical investigation demonstrated that the test implant is more stable in terms of ISQ-values and provides high tolerability for the soft tissue .
CONCLUSIONS	The results show that implant loading at 6 weeks is safe .

###25131453
OBJECTIVE	To evaluate the short-term effects of three different resistance training programs , conducted at low intensity , on physical performance , muscle cross-sectional area ( CSA ) and the capacity to perform daily tasks in older adults living in a geriatric nursing home .
METHODS	Randomized controlled trial , with a 4-month intervention period .
METHODS	A geriatric nursing home in Valencia , Spain .
METHODS	Eighty-nine adults aged 75 to 96 who were independent in their daily activities .
METHODS	After a baseline assessment , the participants were randomly assigned to the control group or one of the three intervention groups : volitional contraction ( VC ; n = 22 ) , neuromuscular electrical stimulation ( NMES ; n = 22 ) , or neuromuscular electrical stimulation superimposed onto voluntary contractions ( NMES + ; n = 22 ) .
METHODS	The intervention focused on knee extension exercises and its intensity was set at 40 % of one-repetition maximum ( 1RM ) .
METHODS	The primary outcome measure was mobility .
METHODS	Secondary outcomes were rectus femoris CSA , balance , aerobic endurance , upper-body strength and the capacity to perform daily tasks .
METHODS	All data were collected at baseline and after the 4-month intervention period .
RESULTS	The two-way ANOVA analysis showed a significant grouptime interaction effect for the mobility ( P = .022 ) , rectus femoris CSA ( P = .001 ) , and the capacity to perform daily tasks ( P = .05 ) .
RESULTS	The within-group analysis found a more prominent effect in the NMES + group .
RESULTS	Significant improvements were seen in rectus femoris CSA and the capacity to perform daily tasks in all intervention groups .
RESULTS	Mobility only improved in the NMES + group ( P = .026 ) .
CONCLUSIONS	From a short-term perspective , NMES + exercise training , performed at low intensity , can improve physical performance , muscle CSA , and the capacity to perform daily activities , and to partially mitigate age-related consequences in older adults .

###25701046
BACKGROUND	Treatment motivation is a key component in the early rehabilitative stages for people with substance use disorders .
BACKGROUND	To date , no music therapy researcher has studied how lyric analysis interventions might affect motivation in a randomized controlled design .
OBJECTIVE	The primary purpose of this study was to determine the effect of lyric analysis interventions on treatment motivation in patients on a detoxification unit using a single-session wait-list control design .
OBJECTIVE	A secondary purpose was to determine if there were between-group differences concerning two contrasting songs used for the lyric analyses .
METHODS	Participants ( N = 104 ) were cluster randomized to a group lyric analysis condition or a wait-list control condition .
METHODS	Participants received either a `` Hurt '' or a `` How to Save a Life '' lyric analysis treatment .
METHODS	The Texas Christian University Treatment Motivation Scale-Client Evaluation of Self at Intake ( CESI ) ( Simpson , 2008 [ 2005 ] ) was used to measure aspects of treatment motivation : problem recognition , desire for help , treatment readiness , pressures for treatment , and total motivation .
RESULTS	Results indicated significant between-group differences in measures of problem recognition , desire for help , treatment readiness , and total motivation , with experimental participants having higher treatment motivation means than control participants .
RESULTS	There was no difference between the two lyric analysis interventions .
CONCLUSIONS	Although the song used for lyric analysis interventions did not affect outcome , a single group-based music therapy lyric analysis session can be an effective psychosocial treatment intervention to enhance treatment motivation in patients on a detoxification unit .
CONCLUSIONS	Limitations , implications for clinical practice , and suggestions for future research are provided .

###25133799
BACKGROUND	The effects of two interventions , Integrated Management of Infectious Disease ( IMID ) training program and On-Site Support ( OSS ) , were tested on 23 facility performance indicators for emergency triage assessment and treatment ( ETAT ) , malaria , pneumonia , tuberculosis , and HIV .
METHODS	The trial was implemented in 36 primary care facilities in Uganda .
METHODS	From April 2010 , two mid-level practitioners per facility participated in IMID training .
METHODS	Eighteen of 36 facilities were randomly assigned to Arm A , and received OSS in 2010 ( nine monthly two-day sessions ) ; 18 facilities assigned to Arm B did not receive OSS in 2010 .
METHODS	Data were collected from Nov 2009 to Dec 2010 using a revised Ministry of Health outpatient medical form and nine registers .
METHODS	We analyzed the effect of IMID training alone by measuring changes before and during IMID training in Arm B , the combined effect of IMID training and OSS by measuring changes in Arm A , and the incremental effect of OSS by comparing changes across Arms A and B.
RESULTS	IMID training was associated with statistically significant improvement in three indicators : outpatients triaged ( adjusted relative risks ( aRR ) = 1.29 , 99 % CI = 1.01,1.64 ) , emergency and priority patients admitted , detained , or referred ( aRR = 1.59 , 99 % CI = 1.04,2.44 ) , and pneumonia suspects assessed ( aRR = 2.31 , 99 % CI = 1.50,3.55 ) .
RESULTS	IMID training and OSS combined was associated with improvements in six indicators : three ETAT indicators ( outpatients triaged ( aRR = 2.03 , 99 % CI = 1.13,3.64 ) , emergency and priority patients admitted , detained or referred ( aRR = 3.03 , 99 % CI = 1.40,6.56 ) , and emergency patients receiving at least one appropriate treatment ( aRR = 1.77 , 99 % CI = 1.10,2.84 ) ) ; two malaria indicators ( malaria cases receiving appropriate antimalarial ( aRR = 1.50 , 99 % CI = 1.04,2.17 ) , and patients with negative malaria test results prescribed antimalarial ( aRR = 0.67 , 99 % CI = 0.46,0.97 ) ) ; and enrollment in HIV care ( aRR = 1.58 , 99 % CI = 1.32,1.89 ) .
RESULTS	OSS was associated with incremental improvement in emergency patients receiving at least one appropriate treatment ( adjusted ratio of RR = 1.84,99 % CI = 1.09,3.12 ) .
CONCLUSIONS	The trial showed that the OSS intervention significantly improved performance in one of 23 facility indicators .

###24429379
BACKGROUND	Glaucoma is one of the leading causes of blindness .
BACKGROUND	Reduction of intraocular pressure is the only proven way to prevent progression of glaucomatous optic neuropathy .
BACKGROUND	The majority of glaucoma patients need to use antiglaucoma ophthalmic solutions over the course of their life .
BACKGROUND	Thus , good adherence and persistency of glaucoma treatment are important factors for better glaucoma care .
OBJECTIVE	The purpose of this study was to investigate the impact of an Internet-based glaucoma care support system on glaucoma medication use .
METHODS	Patients were randomly divided into two groups .
METHODS	The non-Internet access ( NIA ) group consisted of patients who had access to the Internet-based glaucoma care support system during the 4-year period only when they were examined by ophthalmologists .
METHODS	The Internet access ( IA ) group consisted of patients who had the same Internet-based glaucoma care support system access as the NIA group for the first 2 years following enrollment but who were also given free access to the glaucoma care support system for the remaining 2 years .
METHODS	Changes in glaucoma medication use were investigated .
RESULTS	In total , 81 patients in the IA group and 90 patients in the NIA group satisfied the study protocol .
RESULTS	The number of antiglaucoma ophthalmic solutions used during the study period significantly increased in the NIA group ( P < .03 ) but not in the IA group .
RESULTS	The percentages of patients with unchanged , increased , and decreased antiglaucoma ophthalmic solution use during the study period were 61.1 % ( 55/90 ) , 17.8 % ( 16/90 ) , and 3.3 % ( 3/90 ) , respectively , in the NIA group , and 56.8 % ( 46/81 ) , 8.6 % ( 7/81 ) , and 13.6 % ( 11/81 ) , respectively , in the IA group ( P < .001 ) .
RESULTS	Internet access significantly shifted from an increasing intraocular pressure trend to a decreasing trend in the IA group ( P = .002 ) among the patients who did not have any medication changes .
CONCLUSIONS	Allowing patients to browse their medical data may reduce the use and improve the effectiveness of glaucoma medication .
BACKGROUND	UMIN-CTR Clinical Trial Number : UMIN000006982 ; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000008238&language=E ( Archived by WebCite at http://www.webcitation.org/6MRPQeEAv ) .

###25455692
OBJECTIVE	To confirm the superiority of transdermal rotigotine up to 16mg/24h over placebo , and non-inferiority to ropinirole , in Japanese Parkinson 's disease ( PD ) patients on concomitant levodopa therapy .
METHODS	This trial was a randomized , double-blind , double-dummy , three-arm parallel group placebo - and ropinirole-controlled trial .
METHODS	Four-hundred and twenty PD patients whose motor symptoms were not well controlled by levodopa treatment were randomized 2:2:1 to receive rotigotine , ropinirole ( up to 15mg/day ) or placebo during a 16-week treatment period followed by a 4-week taper period .
METHODS	The primary variable was change in the Unified Parkinson 's Disease Rating Scale ( UPDRS ) Part III ( ON state ) sum score from baseline to the end of the treatment period .
RESULTS	The difference in the change in the UPDRS Part III ( ON state ) sum score from baseline to the end of treatment between rotigotine and placebo groups was-6 .41.2 ( 95 % CI : -8.7 to-4 .1 ; p < 0.001 ) , indicating superiority of rotigotine over placebo .
RESULTS	The difference between rotigotine and ropinirole groups was-1 .41.0 ( 95 % CI : -3.2 to 0.5 ) , below the non-inferiority margin , indicating the non-inferiority of rotigotine to ropinirole .
RESULTS	Application site reaction was seen in 57.7 % of the patients in the rotigotine group and in 18.6 % in the ropinirole group ( P < 0.001 ) .
RESULTS	No other safety issue was noted .
CONCLUSIONS	Rotigotine was well tolerated at doses up to 16mg/24h and showed similar efficacy to ropinirole except that the application site reaction was much higher in the rotigotine group .

###25251616
BACKGROUND	Ultrasound-guided foam sclerotherapy and endovenous laser ablation are widely used alternatives to surgery for the treatment of varicose veins , but their comparative effectiveness and safety remain uncertain .
METHODS	In a randomized trial involving 798 participants with primary varicose veins at 11 centers in the United Kingdom , we compared the outcomes of foam , laser , and surgical treatments .
METHODS	Primary outcomes at 6 months were disease-specific quality of life and generic quality of life , as measured on several scales .
METHODS	Secondary outcomes included complications and measures of clinical success .
RESULTS	After adjustment for baseline scores and other covariates , the mean disease-specific quality of life was slightly worse after treatment with foam than after surgery ( P = 0.006 ) but was similar in the laser and surgery groups .
RESULTS	There were no significant differences between the surgery group and the foam or the laser group in measures of generic quality of life .
RESULTS	The frequency of procedural complications was similar in the foam group ( 6 % ) and the surgery group ( 7 % ) but was lower in the laser group ( 1 % ) than in the surgery group ( P < 0.001 ) ; the frequency of serious adverse events ( approximately 3 % ) was similar among the groups .
RESULTS	Measures of clinical success were similar among the groups , but successful ablation of the main trunks of the saphenous vein was less common in the foam group than in the surgery group ( P < 0.001 ) .
CONCLUSIONS	Quality-of-life measures were generally similar among the study groups , with the exception of a slightly worse disease-specific quality of life in the foam group than in the surgery group .
CONCLUSIONS	All treatments had similar clinical efficacy , but complications were less frequent after laser treatment and ablation rates were lower after foam treatment .
CONCLUSIONS	( Funded by the Health Technology Assessment Programme of the National Institute for Health Research ; Current Controlled Trials number , ISRCTN51995477 . )

###24955456
OBJECTIVE	The purpose of the present study was to determine whether lamivudine in combination with transarterial chemoembolization ( TACE ) could reduce hepatitis B virus ( HBV ) activation and improve the survival of patients with hepatocellular carcinoma ( HCC ) .
METHODS	From July 2008 to October 2011 , a total of 181 consecutive HBV-related HCC patients undergoing TACE were randomized to two groups ( 92 : lamivudine , 89 : control ) .
METHODS	Follow up was every 3 months .
METHODS	Primary and secondary end-points were time to progression ( TTP ) and overall survival ( OS ) , respectively , both of which were evaluated by the Kaplan Meier technique and summarized by the hazard ratio .
RESULTS	The level of HBV-DNA became undetectable in 42 ( 45.6 % ) patients in the lamivudine group , compared with 10 ( 11.2 % ) in the control group ( P < 0.001 ) .
RESULTS	The median TTP was 8.2 months in lamivudine group and 4.3 months in control group ( P = 0.005 ) , and lamivudine therapy was an independent protective factor related to TTP ( P = 0.006 ) .
RESULTS	Moreover , 1 - , 2 - , and 3-year survival rates were 83 % , 69 % , and 58 % in lamivudine group and 60 % , 48 % , and 48 % in control group , respectively ( P = 0.002 ) .
RESULTS	With multivariate Cox regression model , lamivudine therapy ( P = 0.002 ) and - fetoprotein ( AFP ) level ( P = 0.003 ) were two independent predictors for OS .
CONCLUSIONS	Lamivudine therapy could reduce HBV activation and improve survival of HCC patients treated with TACE .
CONCLUSIONS	Lamivudine therapy and AFP level are two independent factors affecting OS .

###24375837
BACKGROUND	Pharyngocutaneous fistula is a common complication of total laryngectomy .
BACKGROUND	We hypothesized that perioperative proton pump inhibitor ( PPI ) treatment could reduce the incidence of pharyngocutaneous fistulae .
METHODS	This prospective placebo-controlled double-blind randomized controlled trial compared PPI treatment ( 14 days enteral omeprazole ) with a placebo in patients undergoing primary total laryngectomy .
RESULTS	Forty patients were randomized into PPI ( n = 21 ) and placebo arms ( n = 19 ) .
RESULTS	One of 21 patients receiving omeprazole developed a fistula in comparison to 6 of 19 patients in the placebo group ( p = .04 ) .
RESULTS	No other statistically significant risk factors for pharyngocutaneous fistula were identified .
RESULTS	The mean hospital stay of patients with and without a fistula was 32 and 7.5 days , respectively .
CONCLUSIONS	Pharyngocutaneous fistulae result in prolonged hospitalization and morbidity .
CONCLUSIONS	We observed a statistically significant reduction in fistulae with PPI prophylaxis .
CONCLUSIONS	Further research to better define the role of reflux and antacid management is suggested .

###25713924
OBJECTIVE	The aim of this study was to determine the possible existence of a correlation between the gastric transit time ( GTT ) measured by video capsule endoscopy ( VCE ) and the parameters of gastric emptying determined using 13C breath test ( BreathID system ) .
METHODS	Eight healthy male volunteers participated in this randomized , two-way crossover study .
METHODS	The subjects were randomly assigned to undergo VCE using the PillCam SB capsule endoscopy system or the 13C breath test for 4 hours after a test meal ( 400 kcal per 400 mL ) containing 100 mg of 13C acetic acid administered after overnight fasting .
METHODS	The VCE images were analyzed and the GTT was determined using the proprietary RAPID software .
METHODS	The parameters , namely T lag , T 1/2 and GEC were calculated using the Oridion Research Software ( version ) .
METHODS	The GTT measured by VCE and the parameters of gastric emptying were compared statistically .
RESULTS	No significant correlation was observed between the GTT and T lag ( p = 0.5263 ) , T 1/2 ( p = 0.4100 ) or GEC ( p = 0.2410 ) , as determined by calculation of the Spearmans rank correlation coefficient .
CONCLUSIONS	GTT measured by VCE can not serve as asubstitute for the gastric emptying time measured bythe 13C breath test .

###25471910
BACKGROUND	The efficacy of brace application for the treatment of osteoporotic compression fractures remains unclear .
BACKGROUND	The purpose of this study was to compare the treatment outcomes in patients with osteoporotic compression fractures with regard to whether the patients had no braces , rigid braces , or soft braces .
METHODS	We randomly assigned sixty patients with acute one-level osteoporotic compression fractures within three days of injury to the no-brace , soft-brace , and rigid-brace groups through 1:1:1 allocation .
METHODS	The primary outcome was the baseline adjusted Oswestry Disability Index score at twelve weeks after compression fracture .
METHODS	The non-inferior margin of the Oswestry Disability Index was set at an average of 10 points .
RESULTS	The baseline adjusted Oswestry Disability Index score at twelve weeks after compression fracture in the no-brace group was not inferior to that in the soft-brace or rigid-brace groups .
RESULTS	The mean adjusted Oswestry Disability Index score was 35.95 points ( 95 % confidence interval , 25.42 to 46.47 points ) in the no-brace group and 37.83 points ( 95 % confidence interval , 26.77 to 48.90 points ) in the soft-brace group , with a difference of -1.88 points ( 95 % confidence interval , -7.02 to 9.38 points ) between the groups .
RESULTS	Similarly , the mean adjusted Oswestry Disability Index score was 35.95 points ( 95 % confidence interval , 25.42 to 46.47 points ) in the no-brace group and 33.54 points ( 95 % confidence interval , 23.79 to 43.29 points ) in the rigid-brace group , with a difference of 2.41 points ( 95 % confidence interval , -7.86 to 9.27 points ) between the groups .
RESULTS	During the follow-up assessment period , there was no significant difference among the groups for the overall Oswestry Disability Index scores ( p = 0.260 ) , visual analog scale for pain scores for back pain ( p = 0.292 ) , and anterior body compression ratios ( p = 0.237 ) .
RESULTS	However , the Oswestry Disability Index scores and the visual analog scale scores for back pain significantly improved with time after the fractures ( p < 0.001 ) , and the body compression ratios significantly decreased with time in all three groups ( p < 0.001 ) .
CONCLUSIONS	The Oswestry Disability Index scores for the treatment of compression fractures without a brace were not inferior to those with soft or rigid braces .
CONCLUSIONS	Moreover , the improvement in back pain and progression of anterior body compression were similar among the three groups .
METHODS	Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence .

###25743173
BACKGROUND	Present guidelines emphasise the importance of low concentrations of LDL cholesterol ( LDL-C ) in patients with familial hypercholesterolaemia .
BACKGROUND	In most patients with the disease , however , these concentrations are not achieved with present treatments , so additional treatment is therefore warranted .
BACKGROUND	Inhibition of cholesteryl ester transfer protein has been shown to reduce LDL-C concentrations in addition to regular statin treatment in patients with hypercholesterolaemia or at high risk of cardiovascular disease .
BACKGROUND	We aimed to investigate the safety and efficacy of anacetrapib , a cholesteryl ester transfer protein inhibitor , in patients with heterozygous familial hypercholesterolaemia .
METHODS	In this multicentre , randomised , double-blind , placebo-controlled , phase 3 study , patients aged 18-80 years with a genotype-confirmed or clinical diagnosis of heterozygous familial hypercholesterolaemia , on optimum lipid-lowering treatment for at least 6 weeks , and with an LDL-C concentration of 259 mmol/L or higher without cardiovascular disease or 181 mmol/L or higher with cardiovascular disease from 26 lipid clinics across nine countries were eligible .
METHODS	We randomly allocated participants with a computer-generated allocation schedule ( 2:1 ; block size of six ; no stratification ) to oral anacetrapib 100 mg or placebo for 52 weeks , with a 12 week post-treatment follow-up afterwards .
METHODS	We masked patients , care providers , and those assessing outcomes to treatment groups throughout the study .
METHODS	The primary outcome was percentage change from baseline in LDL-C concentration .
METHODS	We did analysis using a constrained longitudinal repeated measures model .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01524289 .
RESULTS	Between Feb 10 , 2012 , and Feb 12 , 2014 , we randomly allocated 204 patients to anacetrapib and 102 to placebo .
RESULTS	One patient in the anacetrapib group did not receive the drug .
RESULTS	At week 52 , anacetrapib reduced mean LDL-C concentration from 33 mmol/L ( SD 08 ) to 21 mmol/L ( 08 ; percentage change 360 % [ 95 % CI -395 to -325 ] compared with an increase with placebo from 34 mmol/L ( 12 ) to 35 mmol/L ( 16 ; percentage change 37 % [ -12 to 86 ] , with a difference in percentage change between anacetrapib and placebo of -397 % ( 95 % CI -457 to -337 ; p < 00001 ) .
RESULTS	The number of cardiovascular events was increased in patients given anacetrapib compared with those given placebo ( 4 [ 2 % ] of 203 vs none [ 0 % ] of 102 ; p = 01544 ) , but the proportion with adverse events leading to discontinuation was similar ( 12 [ 6 % ] of 203 vs five [ 5 % ] of 102 ) .
CONCLUSIONS	In patients with heterozygous familial hypercholesterolaemia , treatment with anacetrapib for 1 year was well tolerated and resulted in substantial reductions in LDL-C concentration .
CONCLUSIONS	Whether this change leads to a reduction of cardiovascular events will be answered in an outcome study .
BACKGROUND	Merck & Co , Inc. .

###24673048
OBJECTIVE	To observe the clinical efficacy on pain in postmenopausal osteoporosis treated with the warm acupuncture therapy and discuss its effect mechanism .
METHODS	Ninety cases of postmenopausal osteoporosis were randomized into a warm acupuncture group , an electroacupuncture group and a medication group , 30 cases in each group .
METHODS	In the warm acupuncture group and the electroacupuncture group , Dazhu ( BL 11 ) , Shenshu ( BL 23 ) and Xuanzhong ( GB 39 ) were selected bilaterally and stimulated with the warm acupuncture and electroacupuncture therapies respectively , once a day for 30 days totally .
METHODS	In the medication group , caltrate-D tablets were prescribed , 600 mg , once a day for 30 days totally .
METHODS	The changes in the bone density T value , visual analogue scale ( VAS ) score , serum insulin like growth factor 1 ( IGF-1 ) , interleukin 6 ( IL-6 ) and tumor necrosis factor ( TNF-alpha ) were observed before and after treatment in the three groups .
RESULTS	( 1 ) The bone density T value in the patients of postmenopausal osteoporosis did not change obviously after 30 days treatment with the three therapies ; ( 2 ) VAS score was all reduced after treatment , in which , the result in the warm acupuncture group was the most obvious ( 6.73 + / - 0.24 before treatment vs 4.43 + / - 0.26 after treatment ) .
RESULTS	The value after treatment in the warm acupuncture group was different significantly as compared with the electroacupuncture group ( 5.13 + / - 0.31 ) and the medication group ( 5.17 + / - 0.33 , both P < 0.05 ) .
RESULTS	( 3 ) The level of serum IGF-1 was improved after treatment in the warm acupuncture therapy [ ( 119.5 + / - 20.1 ) ng/mL before treatment vs ( 156.5 + / - 23.9 ) ng/mL after treatment ] , which was more apparent as compared with the electroacupuncture group [ ( 136.3 + / - 24.5 ) ng/mL ] and the medication group [ ( 127.7 + / - 22.1 ) ng/mL , all P < 0.05 ] .
RESULTS	Concerning to reducing the levels of IL-6 and TNF-alpha in serum , the results in the warm acupuncture group were superior to the other two groups ( all P < 0.05 ) .
CONCLUSIONS	The warm acupuncture therapy achieves the significant efficacy on pain in postmenopausal osteoporosis , which could be related to increasing the level of IGF-1 , decreasing the levels of IL-6 and TNF-alpha , promoting bone formation and inhibting bone absorption .

###24481031
BACKGROUND	Endobronchial ultrasound-guided transbronchial needle aspiration ( EBUS-TBNA ) is superior to conventional transbronchial needle aspiration ( cTBNA ) in the staging of lung cancer .
BACKGROUND	However , its efficiency in diagnosis of sarcoidosis when combined with endobronchial biopsy ( EBB ) and transbronchial lung biopsy ( TBLB ) has not been studied .
BACKGROUND	This randomized controlled trial compares diagnostic yield of EBUS-TBNA vs cTBNA in combination with EBB and TBLB .
METHODS	Patients with clinical diagnosis of sarcoidosis were randomized 1:1 to EBUS-TBNA or cTBNA .
METHODS	All patients underwent TBLB and EBB .
METHODS	The primary outcome was detection of granulomas .
METHODS	The secondary end points were the individual and cumulative yields of various procedures , serious adverse events , and procedure time .
RESULTS	Of the 130 patients , sarcoidosis was diagnosed in 117 ( 62 cTBNA , 55 EBUS-TBNA ) .
RESULTS	The two groups were similar at baseline .
RESULTS	Granulomas were demonstrated in 104 ( 53 cTBNA , 51 EBUS-TBNA ) patients and were similar in two groups ( 85.5 % vs 92.7 % , P = .34 ) .
RESULTS	Individually , EBUS-TBNA had the highest yield ( 41 of 55 , 74.5 % ) , which was better than cTBNA ( 30 of 62 , 48.4 % , P = .004 ) or EBB ( 40 of 111 , 36.3 % , P < .0001 ) but not TBLB ( 78 of 112 , 69.6 % , P = .54 ) .
RESULTS	Adding EBB/TBLB to cTBNA led to an increase in granuloma detection , whereas the addition of TBLB ( but not EBB ) significantly enhanced the yield of EBUS-TBNA .
RESULTS	The procedure time was significantly longer with EBUS-TBNA .
RESULTS	No major adverse events occurred .
CONCLUSIONS	Individually , EBUS-TBNA has the highest diagnostic yield in sarcoidosis , but it should be combined with TBLB for the optimal yield .
CONCLUSIONS	The diagnostic yield of cTBNA ( plus EBB and TBLB ) is similar to EBUS-TBNA plus TBLB .
BACKGROUND	ClinicalTrials.gov ; No. : NCT01908868 ; URL : www.clinicaltrials.gov .

###25105662
OBJECTIVE	Pharmacological inhibition of the renin-angiotensin-aldosteron system ( RAAS ) may have a beneficial impact on proteinuria and chronic kidney diseases ( CKD ) progression .
OBJECTIVE	Despite recent progress by means of angiotensin-converting enzyme inhibitors ( ACEI ) and angiotensin II receptor blockers ( ARB ) , there is still no optimal therapy which can stop progression of the nephropathy .
OBJECTIVE	Recently introduced aliskiren is the first orally bioavailable direct renin inhibitor approved for the treatment of hypertension .
OBJECTIVE	The purpose was to evaluate the extent of oxidative stress and tubular injury after the direct renin inhibitor , aliskiren compared with placebo and perindopril in patients with non-diabetic chronic kidney disease ( NDCKD ) .
METHODS	A randomized , double-blind , cross-over trial was performed in 14 patients receiving 300mg aliskiren , 10mg perindopril and placebo in random order .
METHODS	The end point was a change in the urinary excretion of N-acetyl -- D-glucosaminidase ( NAG ) and 1-microglobulin ( 1m ) and 15-F ( 2 ) - isoprostane .
RESULTS	Aliskiren reduced excretion of 15-F ( 2 ) - isoprostane ( p = 0.03 ) and 1m ( p = 0.01 ) as compared to placebo .
RESULTS	There were no differences between aliskiren and perindopril in this regard .
RESULTS	NAG urine excretion did not change after aliskiren and perindopril .
CONCLUSIONS	Aliskiren attenuates oxidative stress and may improve functional status of tubules in patients with NDCKD .

###24438370
OBJECTIVE	This phase 3 study evaluated the endometrial safety of bazedoxifene ( BZA ) / conjugated estrogens ( CE ) and bone mineral density ( BMD ) effects vs BZA alone , hormone therapy , and placebo ( PBO ) .
METHODS	The Selective estrogens , Menopause , And Response to Therapy ( SMART ) -5 trial was a multicenter , randomized , double-blind , PBO - and active-controlled study in postmenopausal women with an intact uterus ( N = 1843 ; aged 40-65 years ) seeking treatment for menopausal symptoms .
METHODS	Subjects received daily oral BZA 20 mg/CE 0.45 or 0.625 mg , BZA 20 mg , CE 0.45 mg/medroxyprogesterone acetate ( MPA ) 1.5 mg , or PBO .
METHODS	Primary endpoints were incidence of endometrial hyperplasia and percent change in lumbar spine BMD at 12 months .
METHODS	Secondary endpoints included additional osteoporosis parameters and assessments of tolerability and safety .
RESULTS	At 12 months , endometrial hyperplasia incidence was low ( < 1 % ) and similar among groups .
RESULTS	The BZA/CE group showed significantly greater increases in lumbar spine and total hip BMD vs decreases with PBO ( P < .001 ) ; the CE/MPA group had increased lumbar spine BMD compared with that in the BZA/CE group .
RESULTS	The BZA 20 mg/CE 0.45 and 0.625 mg groups had cumulative amenorrhea rates similar to those with PBO and BZA and significantly higher than those with CE 0.45 mg/MPA 1.5 mg ( P < .001 ) .
RESULTS	The incidence of breast tenderness with BZA/CE was similar to that with PBO and BZA and significantly lower than with that with CE/MPA ( P < .01 ) .
RESULTS	Although adverse event ( AE ) rates were similar among the groups , the incidence of serious AEs overall and AE-related discontinuation rates were higher with CE/MPA than with BZA/CE , BZA , or PBO .
CONCLUSIONS	BZA/CE showed low rates of endometrial hyperplasia and improved lumbar spine and total hip BMD and was generally safe and well tolerated .

###24621971
OBJECTIVE	A pre-planned substudy of a larger multicenter randomized trial was undertaken to compare the efficacy of everolimus with reduced-dose cyclosporine in the prevention of cardiac allograft vasculopathy ( CAV ) after heart transplantation to that of mycophenolate mofetil ( MMF ) with standard-dose cyclosporine .
BACKGROUND	CAV is a major cause of long-term mortality following heart transplantation .
BACKGROUND	Everolimus has been shown to reduce the severity and incidence of CAV as measured by first year intravascular ultrasound ( IVUS ) .
BACKGROUND	MMF , in combination with cyclosporine , has also been shown to have a beneficial effect in slowing the progression of CAV .
METHODS	Study patients were a pre-specified subgroup of the 553-patient Everolimus versus mycophenolate mofetil in heart transplantation : a randomized , multicenter trial who underwent heart transplantation and were randomized to everolimus 1.5 mg or MMF 3 g/day .
METHODS	IVUS was performed at baseline and at 12 months .
METHODS	Evaluable IVUS data were available in 189 patients ( 34.6 % ) .
RESULTS	Increase in average maximal intimal thickness ( MIT ) from baseline to month 12 was significantly smaller in the everolimus 1.5 mg group compared with the MMF group ( 0.03 mm vs. 0.07 mm , p < 0.001 ) .
RESULTS	The incidence of CAV , defined as an increase in MIT from baseline to month 12 of greater than 0.5 mm , was 12.5 % with everolimus versus 26.7 % with MMF ( p = 0.018 ) .
RESULTS	These findings remained irrespective of sex , age , diabetic status , donor disease , and across lipid categories .
CONCLUSIONS	Everolimus was significantly more efficacious than MMF in preventing CAV as measured by IVUS among heart-transplant recipients after 1 year , a finding , which was maintained in a range of patient subpopulations .
CONCLUSIONS	CV surgery : transplantation , ventricular assistance , cardiomyopathy .

###24517309
BACKGROUND	The prevalence of severe and complex obesity is increasing worldwide and surgery may offer an effective and lasting treatment .
BACKGROUND	Laparoscopic adjustable gastric band and Roux-en-Y gastric bypass surgery are the two main surgical procedures performed .
METHODS	This open parallel-group randomised controlled trial will compare the effectiveness , cost-effectiveness and acceptability of gastric band ( Band ) versus gastric bypass ( Bypass ) in adults with severe and complex obesity .
METHODS	It has an internal pilot phase ( in two centres ) with integrated qualitative research to establish effective and optimal methods for recruitment .
METHODS	Adults with a body mass index ( BMI ) of 40 kg/m2 or more , or a BMI of 35 kg/m2 or more and other co-morbidities will be recruited .
METHODS	At the end of the internal pilot the study will expand into more centres if the pre-set progression criteria of numbers and rates of eligible patients screened and randomised are met and if the expected rates of retention and adherence to treatment allocation are achieved .
METHODS	The trial will test the joint hypotheses that Bypass is non-inferior to Band with respect to more than 50 % excess weight loss and that Bypass is superior to Band with respect to health related quality of life ( HRQOL , EQ-5D ) at three years .
METHODS	Secondary outcomes include other weight loss measures , waist circumference and remission/resolution of co-morbidities ; generic and symptom-specific HRQOL ; nutritional blood test results ; resource use ; eating behaviours and adverse events .
METHODS	A core outcome set for reporting the results of obesity surgery will be developed and a systematic review of the evidence for sleeve gastrectomy undertaken to inform the main study design .
CONCLUSIONS	By-Band is the first pragmatic study to compare the two most commonly performed bariatric surgical procedures for severe and complex obesity .
CONCLUSIONS	The design will enable and empower surgeons to learn to recruit and participate in a randomised study .
CONCLUSIONS	Early evidence shows that timely recruitment is possible .
BACKGROUND	Current Controlled Trials ISRCTN00786323 .

###24373229
OBJECTIVE	To document the effects of two doses of dexmedetomidine on the induction characteristics and dose requirements of alfaxalone .
METHODS	Randomized controlled clinical trial .
METHODS	Sixty one client owned dogs , status ASA I-II .
METHODS	Dogs were allocated randomly into three groups , receiving as pre-anaesthetic medication , no dexmedetomidine ( D0 ) , 1 g kg ( -1 ) dexmedetomidine ( D1 ) intramuscularly ( IM ) or 3 g kg ( -1 ) dexmedetomidine IM ( D3 ) .
METHODS	All dogs also received 0.2 mg kg ( -1 ) methadone IM .
METHODS	Level of sedation was assessed prior to induction of anaesthesia .
METHODS	Induction of general anaesthesia was performed with alfaxalone administered intravenously to effect at a rate of 1 mg kg ( -1 ) minute ( -1 ) ; the required dose to achieve tracheal intubation was recorded .
METHODS	Anaesthesia was maintained with isoflurane in oxygen .
METHODS	Cardiopulmonary parameters were recorded throughout the anaesthetic period .
METHODS	Quality of intubation , induction and recovery of anaesthesia were recorded .
METHODS	Quantitative data were compared with one-way anova or Kruskal-Wallis test .
METHODS	Repeated measures were log-transformed and analysed with repeated measures anova ( p < 0.05 ) .
RESULTS	Treatment groups were similar for categorical data , with exception of sedation level ( p < 0.001 ) .
RESULTS	The doses ( mean SD ) of alfaxalone required for intubation were D0 1.68 0.24 , D1 1.60 0.36 and D3 1.41 0.43 , the difference between D0 and D3 being statistically significant ( p = 0.036 ) .
RESULTS	Heart and respiratory rates during the anaesthetic period were significantly different over time and between groups ( p < 0.001 ) ; systolic arterial blood pressure was significantly different over time ( p < 0.001 ) but not between groups ( p = 0.833 ) .
RESULTS	Induction quality and recovery scores were similar between groups ( p = 1.000 and p = 0.414 , respectively ) .
CONCLUSIONS	The administration of alfaxalone resulted in a good quality anaesthetic induction which was not affected by the dose of dexmedetomidine .
CONCLUSIONS	Dexmedetomidine at 3 g kg ( -1 ) IM combined with methadone provides good sedation and enables a reduction of alfaxalone requirements .

###24298767
OBJECTIVE	To observe the clinical efficacy of multiple sclerosis ( MS ) treated with electroacupuncture and acupoint injection .
METHODS	The block randomization method was used to divide 40 cases into an electroacupuncture ( EA ) group and an EA + acupoint injection ( AI ) group , 20 cases in each one .
METHODS	In the EA group , EA was used at corresponding Jiaji ( EX-B 2 ) , Weizhong ( BL 40 ) , Chengshan ( BL 57 ) , etc. .
METHODS	In the EA + AI group , on the basis of EA , the acupoint injection of mouse nerve growth factor was supplemented .
METHODS	The activity of daily life ( ADL ) and expanded disability status score ( EDSS ) were observed in the two groups before and after treatment for the evaluation of the efficacy .
RESULTS	The efficacy was achieved on MS after treatment in both groups ( P < 0.01 ) .
RESULTS	After treatment , the scores of EDSS and Barthel index were ( 3.01 + / - 1.31 ) and ( 83.11 + / - 8.45 ) in the EA + AI group , which were better than those of ( 4.23 + / - 1.21 ) and ( 75.25 + / - 6.25 ) in the EA group ( both P < 0.01 ) .
CONCLUSIONS	EA and AI co-act on reducing disability and improving the life quality in the treatment of MS and have achieved coordinately the significant effects .

###24955623
BACKGROUND	Athletic taping skills are highly valued clinical competencies in the athletic therapy and training profession .
BACKGROUND	The Technical Skill Assessment Instrument ( TSAI ) has been content validated and tested for intrarater reliability .
OBJECTIVE	To test the reliability of the TSAI using a more robust measure of reliability , generalizability theory , and to hypothetically and mathematically project the optimal number of raters and scenarios to reliably measure athletic taping skills in the future .
METHODS	Mount Royal University .
METHODS	Observational study .
METHODS	A total of 29 university students ( 8 men , 21 women ; age = 20.79 1.59 years ) from the Athletic Therapy Program at Mount Royal University .
METHODS	Participants were allowed 10 minutes per scenario to complete prophylactic taping for a standardized patient presenting with ( 1 ) a 4-week-old second-degree ankle sprain and ( 2 ) a thumb that had been hyperextended .
METHODS	Two raters judged student performance using the TSAI .
METHODS	Generalizability coefficients were calculated using variance scores for raters , participants , and scenarios .
METHODS	A decision study was calculated to project the optimal number of raters and scenarios to achieve acceptable levels of reliability .
METHODS	Generalizability coefficients were interpreted the same as other reliability coefficients , with 0 indicating no reliability and 1.0 indicating perfect reliability .
RESULTS	The result of our study design ( 2 raters , 1 standardized patient , 2 scenarios ) was a generalizability coefficient of 0.67 .
RESULTS	Decision study projects indicated that 4 scenarios were necessary to reliably measure athletic taping skills .
CONCLUSIONS	We found moderate reliability coefficients .
CONCLUSIONS	Researchers should include more scenarios to reliably measure athletic taping skills .
CONCLUSIONS	They should also focus on the development of evidence-based practice guidelines and standards of athletic taping and should test those standards using a psychometrically sound instrument , such as the TSAI .

###24225307
BACKGROUND	Nearly all clinical trials investigating patients with pulmonary arterial hypertension ( PAH ) have used the 6-min walk test ( 6MWT ) to evaluate exercise tolerance .
BACKGROUND	The incremental shuttle walk test ( SWT ) , however , has been proposed as a more valid and reproducible alternative to the 6MWT in the evaluation of exercise tolerance in patients with chronic obstructive pulmonary disease .
BACKGROUND	The efficacy of SWT in clinical practice to evaluate the exercise capacity of patients with PAH was investigated .
RESULTS	The peak oxygen consumption ( pVO2 ) and oxygen consumption at anaerobic threshold ( VO2 at AT ) , the gold standard for measurement of exercise tolerance , 6MWT and SWT were measured in 19 clinically stable PAH patients ( WHO functional class II-III ) and the data compared .
RESULTS	There was a higher correlation between SWT walk distance and pVO2 than between 6MWT walk distance and pVO2 ( r = 0.866 and 0.765 , respectively ; P < 0.05 ) , and a higher correlation between SWT walk distance and VO2 at AT than between 6MWT walk distance and VO2 at AT ( r = 0.775 and 0.587 , respectively ; P < 0.05 ) .
RESULTS	No adverse events occurred during the exercise tests .
CONCLUSIONS	SWT is a better reflection than 6MWT of exercise tolerance in PAH patients , and thus is a preferable alternative for assessment of exercise tolerance in PAH patients .

###25195084
BACKGROUND	The development of troponin assays with increased diagnostic sensitivity and greater analytic precision has improved the diagnosis of myocardial infarction in high risk patients .
BACKGROUND	However for those patients at intermediate or low risk in whom a small troponin rise is detected , a cascade of clinical decisions and investigations could result ; potentially having uncertain impact on recurrent ischemic events and increasing bleeding risk and resource utilization .
BACKGROUND	Clinical equipoise remains as to the clinical utility of high sensitivity troponin .
METHODS	We designed a pragmatic randomized clinical trial to evaluate the short and long term clinical impact and resource implications of high sensitivity 5th generation troponin T reporting compared with 4th generation troponin T reporting .
METHODS	Two thousand patients presenting with a suspected acute coronary syndrome were randomized and risk stratified in 5 metropolitan emergency departments in South Australia , Australia .
METHODS	Clinical events occurring after the first 24 h and within 30 days were assessed as the primary endpoint with subsequent events evaluated at 6 and 12 months .
CONCLUSIONS	The true translational benefits of innovations in diagnostic testing need to be evaluated in robust clinical trials as they can be costly to introduce and the adoption process often focuses on sensitivity and specificity at the expense of measuring improvements in clinical outcome .
CONCLUSIONS	The results of this study will provide valuable information on contemporary patterns of troponin utilization on the heterogeneous population of chest pain patients presenting to emergency departments , while providing important information from the clinical practice setting for health administrators , government and policy makers .

###24368224
OBJECTIVE	Tenofovir disoproxil fumarate ( TDF ) is active against lamivudine-resistant hepatitis B virus ( HBV ) infection , but data to support its clinical efficacy in this setting are limited .
METHODS	In a prospective , double-blind , 96-week trial , patients were randomly assigned ( 1:1 ) to groups given TDF ( 300 mg , n = 141 ) or a combination of emtricitabine ( FTC , 200 mg ; n = 139 ) and TDF ( 300 mg , FTC/TDF ) .
METHODS	Patients were hepatitis B e antigen ( HBeAg ) - positive or HBeAg-negative , with levels of HBV DNA 3 log10 IU/mL and lamivudine resistance mutations ( HBV polymerase or reverse transcriptase amino acid substitutions rtM204I/V rtL180M by INNO-LiPA Multi-DR v3 ; Innogenetics , Inc , Alpharetta , GA ) .
METHODS	The primary end point was proportion with HBV DNA < 69 IU/mL ( Roche COBAS Taqman assay ; Roche Molecular Systems , Inc , Pleasanton , CA ) .
RESULTS	Patient groups were well matched for demographic and disease characteristics , including region ( 60 % from Europe ) , HBV genotype ( 45 % genotype D ) , HBeAg status ( 47 % HBeAg-positive ) , and duration of lamivudine treatment ( mean , 3.8 years ) .
RESULTS	At week 96 of treatment , 89.4 % of patients in the TDF group and 86.3 % in the FTC/TDF group had levels of HBV DNA < 69 IU/mL ( P = .43 ) .
RESULTS	HBeAg loss and seroconversion did not differ between groups ; only 1 patient ( 0.7 % ) in the FTC/TDF group lost hepatitis B surface antigen .
RESULTS	Treatment was well tolerated ; confirmed renal events ( creatinine increase of 0.5 mg/dL [ > 44 umol/L ] , creatinine clearance < 50 mL/min , or level of PO4 < 2 mg/dL [ < 0.65 mmol/L ] ) were generally mild and infrequent ( < 1 % ) .
RESULTS	Small reductions ( < 2 % ) in mean bone mineral density of hip and spine were detected by dual-energy x-ray absorptiometry in both groups .
RESULTS	No TDF resistance developed through 96 weeks of treatment .
CONCLUSIONS	TDF alone is safe and effective for treatment of patients with lamivudine-resistant , chronic HBV infection .
CONCLUSIONS	Clinical Trials.gov No , NCT00737568 .

###26111333
BACKGROUND	The purpose of this study was to determine whether administration of postoperative antibiotics affects the incidence of complications after primary cleft palate repair in a developing area .
METHODS	This study was a prospective , double-blind , randomized , placebo-controlled trial composed of 518 consecutive patients who underwent primary cleft palate repair at a single institution .
METHODS	Patients were aged 1 to 43 years at the time of surgery ( median , 9 years ) .
METHODS	The patients were divided randomly into two groups .
METHODS	One group received a 5-day regimen of oral amoxicillin ( 50 mg/kg/day ) postoperatively and the other group received placebo medication .
METHODS	Both groups received a single dose of cefuroxime ( 30 mg/kg ) before incision .
METHODS	Patients and providers were blinded to the randomization .
METHODS	Patients were followed postoperatively for early complications ( infection and wound breakdown ) and for late complications ( palatal fistulas ) .
RESULTS	The incidence of early complications was 13.8 percent among the patients in the placebo group and 8.7 percent among the patients in the antibiotic group ( p = 0.175 ) .
RESULTS	Fistulas were noted in 17.1 percent in the placebo group and in 10.7 percent in the antibiotic group ( p = 0.085 ) .
RESULTS	Logistic regression analysis identified visiting surgeons as the only covariate related to early complications ( OR , 3.71 ; p < 0.001 ) .
RESULTS	However , the use of placebo ( OR , 2.09 ; p = 0.037 ) , female sex ( OR , 2.04 ; p = 0.047 ) , and Veau III and IV ( OR , 3.31 ; p = 0.004 ) were observed as factors associated with the incidence of fistulas .
CONCLUSIONS	The authors ' results indicate that postoperative antibiotic prophylaxis can reduce the incidence of fistulas after primary cleft palate repair in a developing area .

###24369397
OBJECTIVE	To compare post-operative long-term complications and quality of life of two digestive reconstruction procedures after total gastrectomy .
METHODS	A total of 109 gastric cancer patients in Tianjin Medical University Cancer Hospital from March 2012 to February 2013 were prospectively enrolled and randomly divided into functional jejunal interposition ( FJI ) group ( 52 cases ) and Roux-en-Y ( R-Y ) group ( 57 cases ) .
METHODS	The post-operative complications , nutritional status , and the quality of life were compared between two groups .
RESULTS	One , 3 and 6 months after operation , the incidence of R-S syndrome in FJI group was lower as compared to R-Y group [ 13 % ( 6/45 ) vs. 37 % ( 18/49 ) , 3 % ( 1/30 ) vs. 42 % ( 14/33 ) , 5 % ( 1/21 ) vs. 48 % ( 11/23 ) , all P < 0.01 ] , while 3 months after operation , the incidence of reflux and heartburn in FJI group was higher [ 53 % ( 16/30 ) vs. 21 % ( 7/33 ) , P < 0.01 ; 37 % ( 11/30 ) vs. 12 % ( 4/33 ) , P < 0.05 ] .
RESULTS	There were no significant differences in quality of life questionnaire QLQ-C30 between R-Y and FJI groups .
RESULTS	QLQ-STO22 stomach module revealed in FJI group , the eating score was better , but reflux score was worse as compared to R-Y group 3 months after operation ( all P < 0.01 ) .
CONCLUSIONS	Functional jejunal interposition keeps intestinal continuity preserving and food duodenal passing , which is a reasonable digestive reconstruction procedure .

###25649637
OBJECTIVE	To compare central corneal swelling after eight hours of sleep in eyes wearing four different silicone hydrogel lenses with three different powers .
METHODS	Twenty-nine neophyte subjects wore lotrafilcon A ( Dk , 140 ) , balafilcon A ( Dk , 91 ) , galyfilcon A ( Dk , 60 ) and senofilcon A ( Dk , 103 ) lenses in powers -3.00 , -10.00 and +6.00 D on separate nights , in random order , and on one eye only .
METHODS	The contra-lateral eye ( no lens ) served as the control .
METHODS	Central corneal thickness was measured using a digital optical pachometer before lens insertion and immediately after lens removal on waking .
RESULTS	For the +6.00 D and -10.00 D , lotrafilcon A induced the least swelling and galyfilcon A the most .
RESULTS	The +6.00 D power , averaged across lens materials , induced significantly greater central swelling than the -10.00 and -3.00 D ( Re-ANOVA , p < 0.001 ) , ( 7.72.9 % vs. 6.82.8 % and 6.52.5 % respectively ) but there was no difference between -10.00 and -3.00 D. Averaged for power , lotrafilcon A induced the least ( 6.22.8 % ) and galyfilcon A the most ( 7.63.0 % ) swelling at the center ( Re-ANOVA , p < 0.001 ) .
RESULTS	Central corneal swelling with +6.00 D was significantly greater than -10.00 D lens power despite similar levels of average lens transmissibility of these two lens powers .
CONCLUSIONS	The differences in corneal swelling of the lens wearing eyes are consistent with the differences in oxygen transmission of the silicone hydrogel lenses .
CONCLUSIONS	In silicone hydrogel lenses central corneal swelling is mainly driven by central lens oxygen transmissibility .

###24967861
BACKGROUND	Zinc deficiency is common in children among populations in developing areas .
BACKGROUND	Zinc deficiency alters the immune system and the resistance to infections .
OBJECTIVE	To evaluate the effect of two zinc compounds in the prevention of acute respiratory infection and acute diarrhea .
METHODS	Randomized triple-blind community trial with 301 children between 2-5 years of age from six child daycare centers in Medellin , Colombia .
METHODS	Children were distributed in three groups receiving zinc amino acid chelate , zinc sulfate and placebo five days a week for 16 weeks .
METHODS	Daily symptoms of respiratory infection , acute diarrhea and side effects were evaluated .
RESULTS	The incidence of respiratory infection was lower with zinc amino acid chelate ( 1.42 per 1,000 child-days ) compared with placebo ( 3.3 per 1,000 child-days ) ( RR = 0.43 , 95 % CI : 0.196 to 0.950 , p = 0.049 ) and with zinc sulfate ( 1.57 per 1,000 child-days ) ( RR = 0.90 , 95 % CI 0.382 to 2.153 , p = 0.999 ) .
RESULTS	The incidence of acute diarrhea with zinc amino acid chelate ( 0.15 per 1,000 child-days ) was lower than with placebo ( 0.49 per 1,000 child-days ) ( RR = 0.32 , 95 % CI 0.006 to 3.990 , p = 0.346 ) and with zinc sulfate ( 0.78 per 1,000 child-days ) ( RR = 0.20 , 95 % CI : 0.0043 to 1.662 , p = 0.361 ) .
CONCLUSIONS	Zinc amino acid chelate had a better effect in reducing the incidence of acute respiratory infection and acute diarrhea in preschool children when compared with the other groups .

###24613084
BACKGROUND	For maximum effect pre-exposure prophylaxis should be targeted to the subpopulations that account for the largest proportion of infections ( population-attributable fraction [ PAF ] ) and for whom the number needed to treat ( NNT ) to prevent infection is lowest .
BACKGROUND	We aimed to estimate the PAF and NNT of participants in the iPrEx ( Pre-Exposure Prophylaxis Initiative ) trial .
METHODS	The iPrEx study was a randomised controlled efficacy trial of pre-exposure prophylaxis with coformulated tenofovir disoproxil fumarate and emtricitabine in 2499 men who have sex with men ( MSM ) and transgender women .
METHODS	Participants aged 18 years or older who were male at birth were enrolled from 11 trial sites in Brazil , Ecuador , Peru , South Africa , Thailand , and the USA .
METHODS	Participants were randomly assigned ( 1:1 ) to receive either a pill with active pre-exposure prophylaxis or placebo , taken daily .
METHODS	We calculated the association between demographic and risk behaviour during screening and subsequent seroconversion among placebo recipients using a Poisson model , and we calculated the PAF and NNT for risk behaviour subgroups .
METHODS	The iPrEx trial is registered with ClinicalTrials.gov , NCT00458393 .
RESULTS	Patients were enrolled between July 10 , 2007 , and Dec 17 , 2009 , and were followed up until Nov 21 , 2010 .
RESULTS	Of the 2499 MSM and transgender women in the iPrEx trial , 1251 were assigned to pre-exposure prophylaxis and 1248 to placebo .
RESULTS	83 of 1248 patients in the placebo group became infected with HIV during follow-up .
RESULTS	Participants reporting receptive anal intercourse without a condom seroconverted significantly more often than those reporting no anal sex without a condom ( adjusted hazard ratio [ AHR ] 511 , 95 % CI 155-1679 ) .
RESULTS	The overall PAF for MSM and transgender women reporting receptive anal intercourse without a condom was 64 % ( prevalence 60 % ) .
RESULTS	Most of this risk came from receptive anal intercourse without a condom with partners with unknown serostatus ( PAF 53 % , prevalence 54 % , AHR 476 , 95 % CI 144-1571 ) ; by contrast , the PAF for receptive anal intercourse without a condom with an HIV-positive partner was 1 % ( prevalence 1 % , AHR 711 , 95 % CI 070-7275 ) .
RESULTS	The overall NNT per year for the cohort was 62 ( 95 % CI 44-147 ) .
RESULTS	NNTs were lowest for MSM and transgender women self-reporting receptive anal intercourse without a condom ( NNT 36 ) , cocaine use ( 12 ) , or a sexually transmitted infection ( 41 ) .
RESULTS	Having one partner and insertive anal sex without a condom had the highest NNTs ( 100 and 77 , respectively ) .
CONCLUSIONS	Pre-exposure prophylaxis may be most effective at a population level if targeted toward MSM and transgender women who report receptive anal intercourse without a condom , even if they perceive their partners to be HIV negative .
CONCLUSIONS	Substance use history and testing for STIs should also inform individual decisions to start pre-exposure prophylaxis .
CONCLUSIONS	Consideration of the PAF and NNT can aid in discussion of the benefits and risks of pre-exposure prophylaxis with MSM and transgender women .
BACKGROUND	National Institute of Allergy and Infectious Diseases and the Bill & Melinda Gates Foundation .

###24361280
OBJECTIVE	Epidermal growth factor receptor ( EGFR ) mutation testing is standard practice after lung adenocarcinoma diagnosis , and provision of high-quality tumor tissue is ideal .
OBJECTIVE	However , there are knowledge gaps regarding the utility of cytology or low tumor content histology samples to establish EGFR mutation status , particularly with regard to the proportion of testing performed using these sample types , and the lack of an established link with efficacy of treatment .
METHODS	The randomized phase III Iressa Pan-ASia Study ( IPASS ; ClinicalTrials.gov identifier NCT00322452 ) of first-line gefitinib versus chemotherapy analyzed samples meeting preplanned specifications ( n = 437 evaluable for EGFR mutation ; n = 261 mutation-positive ) .
METHODS	This supplementary analysis assessed tumor content and mutation status of histology ( n = 99 ) and cytology samples ( n = 116 ) which were previously unanalyzed due to sample quality , type , and tumor content ( < 100 cells ) .
METHODS	Objective response rate ( ORR ) and change in tumor size with gefitinib treatment were assessed .
RESULTS	EGFR mutation testing was successful in 80 % and 19 % of previously unanalyzed histology and cytology samples , respectively .
RESULTS	Mutations were detected in 54 tumors previously described as mutation-unknown ( histology , n = 45 ; cytology , n = 9 ) .
RESULTS	ORRs in mutation-positive cytology ( 83 % ) and histology ( 74 % ) subgroups were consistent with previous analyses ( 71 % ) .
RESULTS	Tumor size decrease was consistent across previously analyzed and unanalyzed samples ( all mutation subgroups ) , with less consistency across ORRs in mutation-negative cytology ( 16 % ) and histology ( 25 % ) subgroups versus the previous analysis ( 1 % ) .
CONCLUSIONS	Histology samples with low tumor content and cytology samples can be used for EGFR mutation testing ; patients whose mutation status was confirmed using these sample types achieved a response to treatment consistent with those confirmed using high-quality histology samples .
CONCLUSIONS	Better sample quantity/quality can potentially reduce false-negative results .

###24365961
OBJECTIVE	The main objective was to evaluate two models of care for children and adolescents requiring hospitalization due to severe mental illness .
OBJECTIVE	Model 1 : early discharge followed by a newly established home treatment service enhanced by clinical elements according to need ( BeZuHG ) ; Model 2 : admission to an inpatient unit ( TAU ) .
METHODS	100 children and adolescents admitted to inpatient care were randomized to either a control group ( regular inpatient stay ) or an intervention group ( BeZuHG group ) .
METHODS	Sociodemographic data , ICD-10 and DSM-IV diagnoses , health and social functioning , psychopathology , clinical impairment , and service use were assessed pre - and posttreatment regarding effectiveness , outcome , contact time , and acceptance within the families .
RESULTS	Clinical outcome in BeZuHG treatment was as effective as inpatient care .
RESULTS	There was a good acceptance within the families , family resources enhanced treatment outcome , and a significant reduction in length of inpatient stay could be shown .
CONCLUSIONS	The BeZuHG model should be a regular option in child and adolescent psychiatric care .
CONCLUSIONS	Further rigorous evaluation of the model is required : A 1-year follow-up investigating the stability of the shown effects is planned .

###24434090
OBJECTIVE	Examine how different dosing schedules and recent stimulant therapy effect incidence , time to onset , and duration of common treatment-emergent adverse events ( TEAEs ) during atomoxetine treatment .
METHODS	Post hoc analyses including safety data ( open-ended questions ) from 22 pediatric and 3 adult atomoxetine trials ( 1998-2009 ) in patients with attention-deficit/hyperactivity disorder .
METHODS	Most common TEAEs were determined by incidence rates and frequency of consumer and clinician inquiries .
METHODS	Onset and duration of TEAEs with slow versus fast titration , once-daily versus twice-daily dosing , and previous stimulant exposure were compared among treatment groups using Kaplan-Meier methods .
RESULTS	In pediatric patients , the most commonly reported TEAEs were abdominal pain , decreased appetite , fatigue , nausea , somnolence , and vomiting ; time to onset of TEAEs was significantly shorter for once-daily versus twice-daily dosing for all TEAEs ( P .007 ) and for fast versus slow titration for abdominal pain , decreased appetite , and somnolence ( all P values .009 ) ; duration of TEAEs with once-daily dosing was significantly longer for decreased appetite ( P = .001 ) and nausea ( P = .041 ) ; and more common in stimulant-naive patients versus patients with prior stimulant use were abdominal pain , decreased appetite , and fatigue ( P .047 ) .
RESULTS	In adult patients , the most commonly reported TEAEs ( erectile dysfunction data were excluded ) were nausea , insomnia , decreased appetite , urinary hesitation/urinary retention , and fatigue ; insomnia had a significantly shorter time to onset and longer duration with twice-daily versus once-daily dosing ( P .032 ) and fast versus slow titration ( P .007 ) .
CONCLUSIONS	Time to onset and resolution of TEAEs appear dependent on dosing schedule and titration speed .
CONCLUSIONS	These findings can help to better manage tolerability issues and set appropriate expectations for clinicians and patients during atomoxetine titration , potentially improving treatment adherence and success .

###24570078
OBJECTIVE	To investigate the renoprotective effect of nicardipine in patients with pre-existing renal insufficiency undergoing robot-assisted laparoscopic radical prostatectomy ( RALRP ) .
METHODS	Men with preoperative renal insufficiency ( estimated glomerular filtration rate [ eGFR ] < 60 ml/min per 1.73 m ( 2 ) ) were enrolled and randomized to receive either 0.5 g/kg per min nicardipine continuous infusion ( nicardipine group ) or normal saline ( control group ) during RALRP .
METHODS	Renal function was determined by eGFR and serum creatinine concentration .
RESULTS	Serum creatinine levels on postoperative days ( POD ) 1 and 3 were significantly lower than baseline values in the nicardipine group ( n = 50 ) .
RESULTS	In the control group ( n = 50 ) , eGFR was significantly higher on POD 3 than baseline , and was significantly higher than baseline on POD 1 and 3 in the nicardipine group .
RESULTS	The change in eGFR from baseline to POD 1 was significantly higher in the nicardipine group than the control group .
CONCLUSIONS	Continuous infusion of nicardipine during RALRP improved postoperative renal function on POD 1 in patients with pre-existing renal insufficiency .

###25436073
BACKGROUND	There are few comparative studies about the optimal method of pneumatic compression to prevent deep vein thrombosis ( DVT ) .
BACKGROUND	The aim of this prospective randomized study was to compare venous hemodynamic changes and their clinical influences between two graded sequential compression groups ( an alternate sequential compression device [ ASCD ] vs. a simultaneous sequential compression device [ SSCD ] ) .
METHODS	In total , 34 patients ( 68 limbs ) undergoing knee and spine operations were prospectively randomized into two device groups ( ASCD vs. SSCD groups ) .
METHODS	Duplex ultrasonography examinations were performed on the 4th and 7th postoperative days for the detection of DVT and the evaluation of venous hemodynamics .
METHODS	Continuous data for the two groups were analyzed using a two-tailed , unpaired t-test .
METHODS	Relative frequencies of unpaired samples were compared using Fisher exact test .
METHODS	Mixed effects models that might be viewed as ANCOVA models were also considered .
RESULTS	DVT developed in 7 patients ( 20.6 % ) , all of whom were asymptomatic for isolated calf DVTs .
RESULTS	Two of these patients were from the ASCD group ( 11.8 % ) and the other five were from the SSCD group ( 29.4 % ) , but there was no significant difference ( p = 0.331 ) .
RESULTS	Baseline peak velocity , mean velocity , peak volume flow , and total volume flow were enhanced significantly in both device groups ( p < 0.001 ) .
RESULTS	However , the degrees of flow and velocity enhancement did not differ significantly between the groups .
RESULTS	The accumulated expelled volumes for an hour were in favor of the ASCD group .
CONCLUSIONS	Both graded sequential compression devices showed similar results both in clinical and physiological efficacies .
CONCLUSIONS	Further studies are required to investigate the optimal intermittent pneumatic compression method for enhanced hemodynamic efficacy and better thromboprophylaxis .

###25354241
OBJECTIVE	Although the local response induced by acupuncture manipulation has been considered to be among the important factors that induce the effects of acupuncture , this connection has not yet been properly studied with standardized tools .
OBJECTIVE	The aims of this study are to examine the local changes in microcirculation that occur at different manipulation intensities and explore any associations of these changes with the analgesic effects of acupuncture .
METHODS	Twelve healthy volunteers received three acupuncture interventions ( insertion only , a single manipulation , and repeated manipulations ) at the right LI4 ( Hegu or Hapgok ) in random order .
METHODS	Skin blood perfusion was measured in a 100-mm ( 2 ) area ellipse centered on LI4 by using laser Doppler perfusion imaging ( LDPI ) before , during , and after acupuncture stimulation .
METHODS	Pressure pain thresholds ( PPTs ) were measured at ipsilateral areas , including acupoints ST25 ( abdomen ) , LI5 ( hand ) , LI10 ( arm ) , and SP9 ( leg ) .
RESULTS	Repeated acupuncture manipulations enhanced microcirculatory perfusion compared with the insertion-only ( p < 0.01 ) and the single-manipulation ( p < 0.05 ) conditions .
RESULTS	The repeated acupuncture manipulations significantly decreased the pressure pain at ST25 compared with the other groups ( each p < 0.05 ) .
RESULTS	Of note , Spearman correlation analysis revealed significant correlation between changes of local perfusion and PPTs ( r = 0.393 ; p = 0.018 ) .
CONCLUSIONS	These results suggested that repeated manipulation induced higher local microcirculatory changes that were correlated with the analgesic effects at the relevant sites .
CONCLUSIONS	The findings suggest that a proper dose of acupuncture stimulation might be essential to elicit the acupuncture effects .

###24982375
OBJECTIVE	The dose-response relationship between doxorubicin and superabsorbent drug-eluting microspheres has not been established .
OBJECTIVE	In this study , we investigated the relationships between dose and delivery parameters as they pertain to toxicity and response in surgically resectable hepatocellular carcinoma ( HCC ) .
METHODS	Twenty-five patients with resectable HCC were randomly assigned and divided into four groups , each receiving either bland , 25 mg , 50 mg or 75 mg of doxorubicin loaded Super Absorbent Polymer microspheres , with 24 patients undergoing surgical resection .
METHODS	Response Evaluation and Criteria in Solid Tumors ( RECIST ) 1.0 and European Association for the Study of the Liver ( EASL ) - based volumetric response was performed at one month and surgical resection of the reference tumor was performed at two months .
METHODS	Adverse events were collected at regular intervals .
RESULTS	Fifty-six percent of patients demonstrated complete response according to EASL criteria as opposed to 0 % according to RECIST ( v1 .0 ) criteria .
RESULTS	Residual tumor was identified in all groups ( 0 mg : 35 % 28.5 % ; 25 mg : 42 % 30.4 % ; 50 mg : 3.6 % 3.3 % ; and 75 mg : 49.29 % 32.6 % .
RESULTS	A total of 112 adverse events of grades 1-3 occurred ( average 5.1 per patient ) , with no grade 4 or 5 .
RESULTS	No difference was noted between bland embolic and drug-loaded groups .
RESULTS	Subset analysis did demonstrate a significantly increased degree of necrosis in the 50 mg-loaded group ( p = 0.018 ) .
RESULTS	Strong correlation existed between arterial phase Computer Tomography EASL-based response and histopathology ( r = 0.81 ; p < 0.0001 ) .
RESULTS	All groups had residual tumor .
CONCLUSIONS	Histology correlates strongly with one-month post-procedural imaging and response optimized at 50 mg of loading per vial .
CONCLUSIONS	Adverse events were a reflection of embolization , with no relationship between loading dose or administered dose of doxorubicin .

###25064674
BACKGROUND	Increased systolic blood pressure variability between outpatient visits is associated with increased incidence of cardiovascular end points .
BACKGROUND	However , few studies have examined the association of visit-to-visit variability in systolic blood pressure with clinically relevant kidney disease outcomes .
BACKGROUND	We analyzed the association of systolic blood pressure visit-to-visit variability with renal and cardiovascular morbidity and mortality among individuals with diabetes and nephropathy .
METHODS	Observational analysis of IDNT ( Irbesartan Diabetic Nephropathy Trial ) and the RENAAL ( Reduction of End Points in Non-Insulin-Dependent Diabetes With the Angiotensin II Antagonist Losartan ) Study .
METHODS	2,739 participants with type 2 diabetes and nephropathy with at least 1 year of blood pressure measurements available .
METHODS	Systolic blood pressure visit-to-visit variability was calculated from the SD of the systolic blood pressure from 4 visits occurring 3-12 months postrandomization .
RESULTS	The kidney disease outcome was defined as time to confirmed doubling of serum creatinine level , end-stage renal disease , or death ; the cardiovascular outcome was defined as time to cardiovascular death , myocardial infarction , stroke , hospitalization for heart failure , or revascularization .
RESULTS	Mean visit-to-visit variability in systolic blood pressure from 3 to 12 months postrandomization was 12.06.8 ( SD ) mmHg .
RESULTS	Following this ascertainment period , there were 954 kidney disease and 542 cardiovascular events .
RESULTS	Greater systolic blood pressure visit-to-visit variability was associated independently with increased risk of the composite kidney disease end point ( HR per 1-SD increment , 1.08 [ 95 % CI , 1.01-1 .16 ] ; P = 0.02 ) and end-stage renal disease , but not with the cardiovascular outcome .
CONCLUSIONS	Observational study with the potential for confounding .
CONCLUSIONS	In diabetic individuals with nephropathy , systolic blood pressure visit-to-visit variability is associated independently with hard kidney disease outcomes .

###24382548
OBJECTIVE	To evaluate the effects of surface electrical stimulation ( SES ) and to compare them with the effects of the intravaginal electrical stimulation ( IVES ) in women with stress urinary incontinence ( SUI ) .
METHODS	This randomized controlled study included 48 women aged over 50 years , who complained of SUI evaluated according to two structured questions of King 's Health Questionnaire ( KHQ ) and who had not previously undergone physical therapy for SUI .
METHODS	The calculation of the sample size estimated a sample of 45 volunteers with a significance level of 5 % and statistical power of 90 % .
METHODS	The women were randomized to : Surface Electrical Stimulation Group ( SESG ) ( n = 15 ) , Intravaginal Electrical Stimulation Group ( IVESG ) ( n = 15 ) and Control Group ( CG ) ( n = 15 ) .
METHODS	Subjects in the intervention groups were treated with the same parameters of electrical stimulation for 12 sessions .
METHODS	The SESG had four silicone electrodes fixed in the suprapubic and ischial tuberosity regions .
METHODS	The IVES group used an intravaginal electrode .
METHODS	The CG did not receive any treatment during the corresponding time .
METHODS	They were evaluated before and after treatment by a physical therapist who was blind to group allocation .
METHODS	The primary outcomes were urinary leakage , pressure and strength of pelvic floor muscle ( PFM ) contraction .
METHODS	The secondary outcome was quality of life ( QOL ) evaluated by KHQ .
METHODS	Forty-five women completed the study and were included in the analysis .
METHODS	Statistical analysis was performed using the Wilcoxon test for intragroup analysis and Kruskal-Wallis and Mann-Whitney tests for intergroup analysis ( p < 0.05 ) .
RESULTS	There was significant improvement in urinary loss and pressure of contraction in the SESG and IVESG .
RESULTS	PFM strength increased only in the IVESG .
RESULTS	Intergroup analysis found differences after the treatment in : urinary leakage between the SESG and CG ( p < 0.001 ) and the IVESG and CG ( p < 0.001 ) .
RESULTS	Regarding QOL , there was significant reduction in the incontinence impact , limitations of daily activities , physical limitation , emotion , sleep and disposition and severity domains in the SESG ( all p < 0.02 ) and IVESG ( all p < 0.04 ) after the treatments .
CONCLUSIONS	SES and IVES are important treatments to improve the SUI .
CONCLUSIONS	Both improved the QOL , urinary leakage , and strength and pressure of PFM contraction .

###24867162
METHODS	Scarce data are available concerning effects of certain bioactive substances such as Maillard reaction products ( MRP ) on the gut microbiota composition , and the question of how a diet rich in MRP affects gut microbiota in humans is still open .
RESULTS	Two experiments were conducted .
RESULTS	In expt .
RESULTS	1 , adolescents consumed diets either high or low in MRP in a two-period crossover trial ; in expt .
RESULTS	2 , rats were fed diets supplemented or not with MRP model-systems .
RESULTS	Intestinal microbiota composition in fecal ( adolescents ) or cecal ( rat ) samples was assessed by qPCR analysis .
RESULTS	Negative correlations were found in the human assay between lactobacilli numbers and dietary advanced MRP ( r = -0.418 and -0.387 , for hydroxymethylfurfural and carboxymethyl-lysine respectively , p < 0.05 ) , whereas bifidobacteria counts were negatively correlated with Amadori compounds intake .
RESULTS	In the rat assay , total bacteria and lactobacilli were negatively correlated with MRP intake ( r = -0.674 , -0.675 and -0.676 , for Amadori compounds , hydroxymethylfurfural and carboxymethyl-lysine respectively , p < 0.05 ) , but no correlations were found with bifidobacteria .
CONCLUSIONS	Dietary MRP are able to modulate in vivo the intestinal microbiota composition both in humans and in rats , and the specific effects are likely to be linked to the chemical structure and dietary amounts of the different browning compounds .

###24611922
OBJECTIVE	The Americans with Disabilities Act set in motion a series of policies and actions to promote community integration and participation , including for those individuals with psychiatric disabilities .
OBJECTIVE	Measuring participation in this population is in its infancy .
OBJECTIVE	This study examines the test-retest reliability of two modes of administration of a measure that assesses participation in four social life domains and the extent to which participation is viewed as sufficient and important .
METHODS	One hundred and 19 individuals with a diagnosis of schizophrenia , bipolar disorder , or major depression were randomly assigned to either an interviewer - or self-administered method of completing the measure , and filled out the measure again in the same format within 48-72 hr .
RESULTS	Correlations at the individual participation item and scale levels between the two time points were nearly all in the r = .6 -.9 range .
RESULTS	Agreement on the importance and sufficiency of their participation was also consistently high .
RESULTS	The importance of participation in each area ranged from 36 % to 95 % , and among these individuals , between 18 % and 71 % indicated they were not participating as much as desired .
CONCLUSIONS	Community participation of individuals with psychiatric disabilities can be reliably measured using 2 methods of administration as an outcome in rehabilitation research and evaluation studies with this population .
CONCLUSIONS	These individuals are engaged to varying degrees in a wide-range of participation areas in the community that are important , but most not to the degree that they desire .
CONCLUSIONS	More intervention efforts are needed to increase the sufficiency of community participation .

###25599284
BACKGROUND	Reports of long-term tenofovir disoproxil fumarate ( TDF ) treatment in HIV-infected adolescents are limited .
BACKGROUND	We present final results from the open-label ( OL ) TDF extension following the randomized , placebo ( PBO ) - controlled , double-blind phase of GS-US-104-0321 ( Study 321 ) .
METHODS	HIV-infected 12 - to 17-year-olds treated with TDF 300mg or PBO with an optimized background regimen ( OBR ) for 24-48 weeks subsequently received OL TDF plus OBR in a single arm study extension .
METHODS	HIV-1 RNA and safety , including bone mineral density ( BMD ) , was assessed in all TDF recipients .
RESULTS	Eighty-one subjects received TDF ( median duration 96 weeks ) .
RESULTS	No subject died or discontinued OL TDF for safety/tolerability .
RESULTS	At week 144 , proportions with HIV-1 RNA < 50 copies/mL were 30.4 % ( 7 of 23 subjects with baseline HIV-1 RNA > 1000 c/mL initially randomized to TDF ) , 41.7 % ( 5 of 12 subjects with HIV-1 RNA < 1000 c/mL who switched PBO to TDF ) and 0 % ( 0 of 2 subjects failed randomized PBO plus OBR with HIV-1 RNA > 1000 c/mL and switched PBO to TDF ) .
RESULTS	Viral resistance to TDF occurred in 1 subject .
RESULTS	At week 144 , median decrease in estimated glomerular filtration rate was 38.1 mL/min/1 .73 m ( n = 25 ) .
RESULTS	Increases in median spine ( +12.70 % , n = 26 ) and total body less head BMD ( +4.32 % , n = 26 ) and height-age adjusted Z-scores ( n = 21 ; +0.457 for spine , +0.152 for total body less head ) were observed at week 144 .
RESULTS	Five of 81 subjects ( 6 % ) had persistent > 4 % BMD decreases from baseline .
CONCLUSIONS	Some subjects had virologic responses to TDF plus OBR , and TDF resistance was rare .
CONCLUSIONS	TDF was well tolerated and can be considered for treatment of HIV-infected adolescents .

###25226009
OBJECTIVE	To evaluate efficacy , safety , and tolerability of a fixed combination clindamycin phosphate 1.2 % and benzoyl peroxide 3.75 % ( clindamycin-BP 3.75 % ) aqueous gel in moderate to severe acne vulgaris .
METHODS	A total of 498 patients , 12-40 years of age , were randomized to receive clindamycin-BP 3.75 % or vehicle in a double-blind , controlled 12-week , 2-arm study evaluating safety and efficacy using inflammatory and noninflammatory lesion counts , Evaluator Global Severity Scores ( EGSS ) and subject self-assessment ( SSA ) .
METHODS	In addition , patients completed a patient satisfaction survey ( PSS ) , acne-specific QoL questionnaire , and assessed their facial skin for shininess/oiliness .
RESULTS	Clindamycin-BP 3.75 % demonstrated statistical superiority to vehicle in reducing both inflammatory and noninflammatory lesions and acne severity .
RESULTS	Clindamycin-BP 3.75 % showed greater efficacy relative to vehicle in assessments of skin oiliness , SSA and PSS .
RESULTS	No substantive differences were seen in cutaneous tolerability among treatment groups and no patients discontinued treatment with Clindamycin-BP 3.75 % because of adverse events .
CONCLUSIONS	Data from controlled studies may differ from clinical practice .
CONCLUSIONS	It is not possible to determine the contributions from the individual active ingredients .
CONCLUSIONS	Clindamycin-BP 3.75 % provides statistically significant greater efficacy than vehicle with a favorable safety and tolerability profile .

###24590745
OBJECTIVE	To determine if the belief that thirdhand smoke is harmful to children is associated with smoking parents ' attitudes , home or car smoking policies , and quitting behaviors .
METHODS	Data from a national randomized controlled trial , Clinical Effort Against Secondhand Smoke Exposure , assessed thirdhand smoke beliefs of 1947 smoking parents in an exit survey after a pediatric office visit in 10 intervention and 10 control practices .
METHODS	Twelve-month follow-up data were collected from 1355 parents .
METHODS	Multivariable logistic regression determined whether belief that thirdhand smoke harms the health of children is independently associated with parental behaviors and attitudes 12 months later .
METHODS	A ( 2 ) test assessed whether parents who disagreed that thirdhand smoke is harmful were more likely to make a quit attempt if they later believed that thirdhand smoke is harmful .
RESULTS	Belief at the exit survey that thirdhand smoke is harmful was independently associated with having a strictly enforced smoke-free home policy ( adjusted odds ratio : 2.05 ; 95 % CI : 1.37-3 .05 ) and car policy ( adjusted odds ratio : 1.69 ; 95 % CI : 1.04-2 .74 ) at the 12-month follow-up .
RESULTS	A significantly higher percentage ( 71 % vs 50 % ) of parents who did not hold the thirdhand smoke harm belief at baseline made at least 1 quit attempt if they agreed that thirdhand smoke is harmful at the 12-month follow-up ( P = .02 ) .
CONCLUSIONS	Thirdhand smoke harm belief was associated with a strictly enforced smoke-free home and car and attempts to quit smoking .
CONCLUSIONS	Sensitizing parents to thirdhand smoke risk could facilitate beneficial tobacco control outcomes .

###24589566
OBJECTIVE	Active video games may offer an effective strategy to increase physical activity in overweight and obese children .
OBJECTIVE	However , the specific effects of active gaming when delivered within the context of a pediatric weight management program are unknown .
OBJECTIVE	To evaluate the effects of active video gaming on physical activity and weight loss in children participating in an evidence-based weight management program delivered in the community .
METHODS	Group-randomized clinical trial conducted during a 16-week period in YMCAs and schools located in Massachusetts , Rhode Island , and Texas .
METHODS	Seventy-five overweight or obese children ( 41 girls [ 55 % ] , 34 whites [ 45 % ] , 20 Hispanics [ 27 % ] , and 17 blacks [ 23 % ] ) enrolled in a community-based pediatric weight management program .
METHODS	Mean ( SD ) age of the participants was 10.0 ( 1.7 ) years ; body mass index ( BMI ) z score , 2.15 ( 0.40 ) ; and percentage overweight from the median BMI for age and sex , 64.3 % ( 19.9 % ) .
METHODS	All participants received a comprehensive family-based pediatric weight management program ( JOIN for ME ) .
METHODS	Participants in the program and active gaming group received hardware consisting of a game console and motion capture device and 1 active game at their second treatment session and a second game in week 9 of the program .
METHODS	Participants in the program-only group were given the hardware and 2 games at the completion of the 16-week program .
METHODS	Objectively measured daily moderate-to-vigorous and vigorous physical activity , percentage overweight , and BMI z score .
RESULTS	Participants in the program and active gaming group exhibited significant increases in moderate-to-vigorous ( mean [ SD ] , 7.4 [ 2.7 ] min/d ) and vigorous ( 2.8 [ 0.9 ] min/d ) physical activity at week 16 ( P < .05 ) .
RESULTS	In the program-only group , a decline or no change was observed in the moderate-to-vigorous ( mean [ SD ] net difference , 8.0 [ 3.8 ] min/d ; P = .04 ) and vigorous ( 3.1 [ 1.3 ] min/d ; P = .02 ) physical activity .
RESULTS	Participants in both groups exhibited significant reductions in percentage overweight and BMI z scores at week 16 .
RESULTS	However , the program and active gaming group exhibited significantly greater reductions in percentage overweight ( mean [ SD ] , -10.9 % [ 1.6 % ] vs -5.5 % [ 1.5 % ] ; P = .02 ) and BMI z score ( -0.25 [ 0.03 ] vs -0.11 [ 0.03 ] ; P < .001 ) .
RESULTS	CONCLUSIONS AND RELEVANCE Incorporating active video gaming into an evidence-based pediatric weight management program has positive effects on physical activity and relative weight .
RESULTS	TRIAL REGISTRATION clinicaltrials.gov Identifier : NCT01757925 .

###24985376
OBJECTIVE	To investigate the impact of self-efficacy theory health education in patients of diabetic osteoporosis .
METHODS	We used SPSS 19.0 software to generate random numbers and 260 diabetic osteoporosis patients were randomly divided into an observation group and a control group .
METHODS	There was 130 patients in observation group , 130 in control group .
METHODS	The self-efficacy theory health education was carried out in observation group , and routine health education in control group .
METHODS	SF-36 questionnaire was used to assess the quality of life .
METHODS	Osteoporosis self-efficacy scale ( OSES ) was used to assess self-efficacy .
METHODS	Bone mineral density ( BMD ) was measured by dual energy X-ray absorptiometry .
METHODS	Blood glucose was detected by glucose oxidase method .
METHODS	Glycosylated hemoglobin was detected by high efficiency liquid chromatography to estimate the index change before intervention and after one year 's follow up .
RESULTS	The number of patients that had completed follow-up was 104 in control group and 107 in observation group .
RESULTS	The self-efficacy scores , movement efficiency scores and calcium intake efficiency scores were all higher in intervention group ( ( 82.25 13.54 ) , ( 79.26 15.37 ) , ( 84.39 17.09 ) points ) than which in the control group ( ( 71.14 14.19 ) , ( 63.89 19.87 ) , ( 75.24 10.70 ) points ) after one year 's follow up , there were significant differences in two groups ( t values were 6.04 , 7.95 , 5.77 , all P values < 0.05 ) .
RESULTS	The scores of quality of life in the dimension of general health , vitality , social function , role emotional and mental health were all higher in intervention group ( ( 75.29 14.90 ) , ( 68.61 17.38 ) , ( 75.74 18.50 ) , ( 71.22 17.93 ) , ( 73.69 14.40 ) points ) than in the control group ( ( 44.25 11.01 ) , ( 47.39 18.90 ) , ( 63.54 15.95 ) , ( 49.04 19.36 ) , ( 55.15 19.74 ) points ) , there were significant differences in two groups ( t values were 8.45 , 8.83 , 6.92 , 8.79 , 8.05 , all P values < 0.05 ) .
RESULTS	Fasting blood-glucose 2 hour postprandial blood glucose and glycosylated hemoglobin were all lower in intervention group ( ( 7.29 1.81 ) mmol/L , ( 8.21 2.37 ) mmol/L , ( 6.59 0.92 ) % ) than in the control group ( ( 8.53 1.66 ) mmol/L , ( 9.41 3.30 ) mmol/L , ( 7.66 1.50 ) % ) , there were significant differences in two groups ( t values were 5.33 , 4.67 , 5.49 , all P values < 0.05 ) .
RESULTS	There were 1 ( 0.93 % ) fracture case in observation group and 7 ( 6.73 % ) cases in control group during one year 's follow up , there are significant difference in two groups ( ( 2 ) = 4.86 , P = 0.028 ) .
CONCLUSIONS	The self-efficacy theory health education may improve the quality of life and decreased fracture risk of diabetic osteoporosis patients .

###25344019
OBJECTIVE	Cranial nerve palsy ( CNP ) and neck haematoma are complications of carotid endarterectomy ( CEA ) .
OBJECTIVE	The effects of patient factors and surgical technique were analysed on the risk , and impact on disability , of CNP or haematoma in the surgical arm of the International Carotid Stenting Study ( ICSS ) , a randomized controlled clinical trial of stenting versus CEA in patients with symptomatic carotid stenosis .
METHODS	A per-protocol analysis of early outcome in patients receiving CEA in ICSS is reported .
METHODS	Haematoma was defined by the surgeon .
METHODS	CNP was confirmed by an independent neurologist .
METHODS	Factors associated with the risk of CNP and haematoma were investigated in a binomial regression analysis .
RESULTS	Of the patients undergoing CEA , 45/821 ( 5.5 % ) developed CNP , one of which was disabling ( modified Rankin score = 3 at 1 month ) .
RESULTS	Twenty-eight ( 3.4 % ) developed severe haematoma .
RESULTS	Twelve patients with haematoma also had CNP , a significant association ( p < .01 ) .
RESULTS	Independent risk factors modifying the risk of CNP were cardiac failure ( risk ratio [ RR ] 2.66 , 95 % CI 1.11 to 6.40 ) , female sex ( RR 1.80 , 95 % CI 1.02 to 3.20 ) , the degree of contralateral carotid stenosis , and time from randomization to treatment > 14 days ( RR 3.33 , 95 % CI 1.05 to 10.57 ) .
RESULTS	The risk of haematoma was increased in women , by the prescription of anticoagulant drugs pre-procedure and in patients with atrial fibrillation , and was decreased in patients in whom a shunt was used and in those with a higher baseline cholesterol level .
CONCLUSIONS	CNP remains relatively common after CEA , but is rarely disabling .
CONCLUSIONS	Women should be warned about an increased risk .
CONCLUSIONS	Attention to haemostasis might reduce the incidence of CNP .
CONCLUSIONS	ICSS is a registered clinical trial : ISRCTN 25337470 .

###24395525
BACKGROUND	Vesnarinone Trial ( VesT ) was a three-armed , placebo-controlled , randomized clinical trial designed to study the effects of 30 mg or 60 mg/day vesnarinone .
BACKGROUND	Certain contradictory results involving patient health-related quality-of-life ( HRQOL ) and overall survival ( OS ) have made a definitive and unified conclusion difficult .
METHODS	To reconcile these findings , we have focused on the HRQOL-adjusted OS , commonly known as quality-adjusted life years ( QALYs ) .
METHODS	Currently , analyses of QALYs incorporate a single HRQOL subscale .
METHODS	However , the VesT HRQOL instrument had two subscales : physical ( PHYS ) and emotional ( EMOT ) .
METHODS	We have developed new ways to visualize and compare EMOT - and PHYS-adjusted OS .
RESULTS	In each VesT arm , there was an increased probability of superior EMOT-adjusted OS , compared to PHYS-adjusted OS .
RESULTS	The magnitude of these findings was comparable across trial arms .
RESULTS	Despite inferior survival and superior EMOT and PHYS scores , the 60-mg/day arm presents similar EMOT - and PHYS-adjusted OS compared to the placebo arm .
CONCLUSIONS	We have provided a fresh perspective on the complex interactions between multiple HRQOL dimensions and OS .
CONCLUSIONS	These novel methods address the burgeoning need for robust information on the interplay between OS and HRQOL from a patient , clinical care and public policy perspective .

###25399733
BACKGROUND	Hypertension is common in autosomal dominant polycystic kidney disease ( ADPKD ) and is associated with increased total kidney volume , activation of the renin-angiotensin-aldosterone system , and progression of kidney disease .
METHODS	In this double-blind , placebo-controlled trial , we randomly assigned 558 hypertensive participants with ADPKD ( 15 to 49 years of age , with an estimated glomerular filtration rate [ GFR ] > 60 ml per minute per 1.73 m ( 2 ) of body-surface area ) to either a standard blood-pressure target ( 120/70 to 130/80 mm Hg ) or a low blood-pressure target ( 95/60 to 110/75 mm Hg ) and to either an angiotensin-converting-enzyme inhibitor ( lisinopril ) plus an angiotensin-receptor blocker ( telmisartan ) or lisinopril plus placebo .
METHODS	The primary outcome was the annual percentage change in the total kidney volume .
RESULTS	The annual percentage increase in total kidney volume was significantly lower in the low-blood-pressure group than in the standard-blood-pressure group ( 5.6 % vs. 6.6 % , P = 0.006 ) , without significant differences between the lisinopril-telmisartan group and the lisinopril-placebo group .
RESULTS	The rate of change in estimated GFR was similar in the two medication groups , with a negative slope difference in the short term in the low-blood-pressure group as compared with the standard-blood-pressure group ( P < 0.001 ) and a marginally positive slope difference in the long term ( P = 0.05 ) .
RESULTS	The left-ventricular-mass index decreased more in the low-blood-pressure group than in the standard-blood-pressure group ( -1.17 vs. -0.57 g per square meter per year , P < 0.001 ) ; urinary albumin excretion was reduced by 3.77 % with the low-pressure target and increased by 2.43 % with the standard target ( P < 0.001 ) .
RESULTS	Dizziness and light-headedness were more common in the low-blood-pressure group than in the standard-blood-pressure group ( 80.7 % vs. 69.4 % , P = 0.002 ) .
CONCLUSIONS	In early ADPKD , the combination of lisinopril and telmisartan did not significantly alter the rate of increase in total kidney volume .
CONCLUSIONS	As compared with standard blood-pressure control , rigorous blood-pressure control was associated with a slower increase in total kidney volume , no overall change in the estimated GFR , a greater decline in the left-ventricular-mass index , and greater reduction in urinary albumin excretion .
CONCLUSIONS	( Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others ; HALT-PKD [ Study A ] ClinicalTrials.gov number , NCT00283686 . )

###24964299
OBJECTIVE	Laryngoscopy and stimuli inside the trachea cause an intense sympatho-adrenal response .
OBJECTIVE	Remifentanil seems to be the optimal opioid for rigid bronchoscopy due to its potent and short-acting properties .
OBJECTIVE	The purpose of this study was to compare bolus propofol and ketamine as an adjuvant to remifentanil-based total intravenous anesthesia for pediatric rigid bronchoscopy .
METHODS	Forty children under 12 years of age who had been scheduled for a rigid bronchoscopy were included in this study .
METHODS	After midazolam premedication , a 1 g/kg/min remifentanil infusion was started , and patients were randomly allocated to receive either propofol ( Group P ) or ketamine ( Group K ) as well as mivacurium for muscle relaxation .
METHODS	Anesthesia was maintained with a 1 g/kg/min remifentanil infusion and bolus doses of propofol or ketamine .
METHODS	After the rigid bronchoscopy , 0.05 g/kg/min of remifentanil was maintained until extubation .
METHODS	Hemodynamic parameters , emergence characteristics , and adverse events were evaluated .
RESULTS	The demographic variables were comparable between the two groups .
RESULTS	The decrease in mean arterial pressure from baseline values to the lowest values during rigid bronchoscopy was greater in Group P ( p = 0.049 ) , while the reduction in the other parameters and the incidence of adverse events were comparable between the two groups .
RESULTS	The need for assisted or controlled mask ventilation after extubation was higher in Group K.
CONCLUSIONS	Remifentanil-based total intravenous anesthesia with propofol or ketamine as an adjuvant drug along with controlled ventilation is a viable technique for pediatric rigid bronchoscopy .
CONCLUSIONS	Ketamine does not provide a definite advantage over propofol with respect to hemodynamic stability during rigid bronchoscopy , while propofol seems more suitable during the recovery period .

###24732026
OBJECTIVE	Proton-pump inhibitors ( PPIs ) reduce acid gastroesophageal reflux ( GER ) and esophageal acid exposure in infants ; however , they do not reduce total GER or symptoms attributed to GER .
OBJECTIVE	Reflux is reduced in the left lateral position ( LLP ) .
OBJECTIVE	We hypothesize that the effect of LLP in combination with acid suppression is most effective in reducing GER symptoms in infants .
METHODS	In this prospective sham-controlled trial , infants ( 0-6 months ) with symptoms suggestive of gastroesophageal reflux disease were studied using 8-hour pH-impedance , cardiorespiratory and video monitoring , direct nurse observation , and a validated questionnaire .
METHODS	Infants demonstrating a positive GER symptom association were randomized to 1 of 4 groups ; PPI + LLP , PPI + head of cot elevation ( HE ) , antacid ( AA ) + LLP , or AA + HE .
METHODS	HE and AA were considered `` sham '' therapies .
METHODS	After 2 weeks the 8-hour studies were repeated on-therapy .
RESULTS	Fifty-one patients were included ( aged 13.6 [ 2-26 ] weeks ) .
RESULTS	PPI + LLP was most effective in reducing GER episodes ( 69 [ 13 ] to 46 [ 10 ] , P < 0.001 ) and esophageal acid exposure ( median [ interquartile range ] 8.9 % [ 3.1 % -18.1 % ] to 1.1 % [ 0 % -4.4 % ] , P = 0.02 ) .
RESULTS	No treatment group showed improvement in crying/irritability , although vomiting was reduced in AA + LLP ( from 7 [ 2 ] to 2 [ 0 ] episodes P = 0.042 ) .
RESULTS	LLP compared with HE produced greater reduction in total GER ( -21 [ 4 ] vs -10 [ 4 ] , P = 0.056 ) , regardless of acid-suppressive therapy .
RESULTS	Acid exposure was reduced on PPI compared with AA ( -6.8 [ 2.1 ] vs -0.9 [ 1.4 ] % , pH < 4 , P = 0.043 ) regardless of positional intervention .
RESULTS	A post-hoc analysis using automated analysis software revealed a significant reduction in crying symptoms in the PPI + LLP group ( 99 [ 65-103 ] to 62 [ 32-96 ] episodes , P = 0.018 ) .
CONCLUSIONS	`` Symptomatic gastroesophageal reflux disease '' implies disease causation for distressing infant symptoms .
CONCLUSIONS	In infants with symptoms attributed to GER , LLP produced a significant reduction in total GER , but did not result in a significant improvement in symptoms other than vomiting ; however , automated analysis appeared to identify infants with GER-associated crying symptoms who responded to positioning therapy .
CONCLUSIONS	This is an important new insight for future research .

###25764513
BACKGROUND	A bivalent killed whole cell oral cholera vaccine has been found to be safe and efficacious for five years in the cholera endemic setting of Kolkata , India , when given in a two dose schedule , two weeks apart .
BACKGROUND	A randomized controlled trial revealed that the immune response was not significantly increased following the second dose compared to that after the first dose .
BACKGROUND	We aimed to evaluate the impact of an extended four week dosing schedule on vibriocidal response .
RESULTS	In this double blind randomized controlled non-inferiority trial , 356 Indian , non-pregnant residents aged 1 year or older were randomized to receive two doses of oral cholera vaccine at 14 and 28 day intervals .
RESULTS	We compared vibriocidal immune responses between these schedules .
RESULTS	Among adults , no significant differences were noted when comparing the rates of seroconversion for V. cholerae O1 Inaba following two dose regimens administered at a 14 day interval ( 55 % ) vs the 28 day interval ( 58 % ) .
RESULTS	Similarly , no differences in seroconversion were demonstrated in children comparing the 14 ( 80 % ) and 28 day intervals ( 77 % ) .
RESULTS	Following 14 and 28 day dosing intervals , vibriocidal response rates against V. cholerae O1 Ogawa were 45 % and 49 % in adults and 73 % and 72 % in children respectively .
RESULTS	Responses were lower for V. cholerae O139 , but similar between dosing schedules for adults ( 20 % , 20 % ) and children ( 28 % , 20 % ) .
CONCLUSIONS	Comparable immune responses and safety profiles between the two dosing schedules support the option for increased flexibility of current OCV dosing .
CONCLUSIONS	Further operational research using a longer dosing regimen will provide answers to improve implementation and delivery of cholera vaccination in endemic and epidemic outbreak scenarios .

###24308723
BACKGROUND	The association between testosterone deficiency and insulin resistance in men with type 2 diabetes is well established and current endocrine society guidelines recommend the measurement of testosterone levels in all men with type 2 diabetes or erectile dysfunction .
OBJECTIVE	We report the first double-blind , placebo-controlled study conducted exclusively in a male type 2 diabetes population to assess metabolic changes with long-acting testosterone undecanoate ( TU ) .
METHODS	The type 2 diabetes registers of seven general practices identified 211 patients for a 30-week double-blind , placebo-controlled study of long-acting TU 1,000 mg followed by 52 weeks of open-label use .
METHODS	Because of the established impact of age , obesity , and depression on sexual function , these variables were also assessed for influence on metabolic parameters .
METHODS	Changes in glycated hemoglobin ( HbA1c ) and the level of testosterone at which response are achieved .
RESULTS	Treatment with TU produced a statistically significant reduction in HbA1c at 6 and 18 weeks and after a further 52 weeks of open-label medication most marked in poorly controlled patients with baseline HbA1c greater than 7.5 where the reduction was 0.41 % within 6 weeks , and a further 0.46 % after 52 weeks of open-label use .
RESULTS	There was significant reduction in waist circumference , weight , and body mass index in men without depression , and improvements were related to achieving adequate serum levels of testosterone .
RESULTS	There were no significant safety issues .
CONCLUSIONS	Testosterone replacement therapy significantly improved HbA1c , total cholesterol , and waist circumference in men with type 2 diabetes .
CONCLUSIONS	Improvements were less marked in men with depression at baseline , and therapeutic responses were related to achieving adequate serum testosterone levels .
CONCLUSIONS	Current advice on 3 - to 6-month trials of therapy may be insufficient to achieve maximal response .
CONCLUSIONS	Patients reported significant improvements in general health .

###25076235
OBJECTIVE	This randomized trial evaluated the feasibility and safety of thulium 2010-nm laser to perform anatomic lung resections in patients with incomplete fissures , as compared to mechanical staplers with or without sealants .
METHODS	Seventy-two patients scheduled for segmentectomy or lobectomy were enrolled .
METHODS	After intraoperative confirmation of the extent of resection and incomplete fissures ( Craig type 2 , 3 or 4 ) , they were randomized and allocated to one of the following arms : laser resection by thulium ( group A ) or standard resection with mechanical staplers with or without sealants ( group B ) .
METHODS	The primary endpoints of the study included analysis of intraoperative and postoperative course , and costs .
RESULTS	Thirty-eight patients were assigned to group A ( 32 lobectomies , 6 segmentectomies ) and 34 to group B ( 31 lobectomies , 3 segmentectomies ) .
RESULTS	No 30-day mortality was observed .
RESULTS	Median operative times were 145.0 minutes ( group A ) and 142.5 minutes ( group B , P = 0.83 ) .
RESULTS	The median time to drainage removal was 5 days ( group A ) and 4 days ( group B ) , while the median length of hospital stay was the same ( 7 days ) .
RESULTS	Prolonged air leaks > 7 days were observed in 12 patients of group A ( 32 % ) and 10 patients of group B ( 29 % , P = 0.46 ) .
RESULTS	Unpredictable late pneumothorax occurred in 3 patients of group A ( 2 readmissions , need for 1 repeat thoracotomy ) .
RESULTS	Cost analysis demonstrated an intraoperative advantage for group A ( mean 807 212 euro ) versus group B ( mean 1,047 + / -276 euro , P < 0.0001 ) , but the differences in total costs could be due to chance ( P = 0.83 ) .
CONCLUSIONS	The use of laser to complete fissures can lead to late pneumothorax , even in the absence of postoperative air leaks .
CONCLUSIONS	Moreover , the use of laser to complete fissures did not prove to reduce overall costs .
CONCLUSIONS	Trial Registration Identification Number : 41/10 ( IRB00001457 - FWA00001798 - IORG0001063 ) .

###25195352
OBJECTIVE	Childhood obesity is a major public health concern worldwide while the current epidemic may be secondary to over consumption of high-fat , energy-rich foods .
OBJECTIVE	Purslane ( Portulaca oleracea L. ) has been traditionally used in medicine for several antioxidant and anti-atherogenic activities .
OBJECTIVE	In this study the anti-dyslipidemic effects of Poleracea was evaluated in obese adolescents .
METHODS	In this triple-blinded randomized placebo-controlled clinical trial which was done from July 2011 to June 2012 , obese adolescent patients whom were referred to the Isfahan Cardiovascular Research Institute ( Iran ) were randomly allocated to the two arms of cases and controls .
METHODS	The cases group was asked to take one capsule containing powdered P. oleracea seeds ( 500 milligrams ) two times a day for one month , and the controls group were asked to take identical but placebo ( lactose ) capsules in the same way .
METHODS	Biochemical parameters including 12-hours fasting serum levels of total cholesterol , low-density lipoprotein cholesterol ( LDL-C ) , high-density lipoprotein cholesterol ( HDL-C ) , and triglycerides ( TG ) were measured before the initiation and after the completion of the study protocol .
RESULTS	Total cholesterol , LDL-C , and TG showed statistically significant changes over time ( one month ) in the P. oleracea group ( p < 0.05 ) .
RESULTS	However , between-group analysis using general linear model ( multivariate ) test revealed that the differences in the mentioned parameters between two study groups were statistically significant just for LDL-C and TG , while others did not differ significantly .
CONCLUSIONS	P. oleracea L. may have positive effects on serum lipids profile which may be attributed to its polyphenolic and antioxidant compounds .
CONCLUSIONS	This herbal drug seems to be well-tolerated in adolescent population as well .
CONCLUSIONS	Further studies are recommended .

###25201183
OBJECTIVE	To examine whether optimism/pessimism reliably predicts depression and whether such function is stable also in older age .
METHODS	In a prospective study , we observed a representative sample of n = 4,046 primary care patients over 5 years .
METHODS	The Life Orientation Test ( LOT-R , measuring optimism/pessimism ) and the Depression-Screening Questionnaire were applied .
METHODS	Medical diagnoses were recorded by the treating physician in a structured medical interview .
RESULTS	Depression could only be predicted by LOT-R scores in younger-age cohorts .
RESULTS	In older adults , test stability and predictive accuracy of optimism/pessimism were markedly reduced , while somatic comorbidity gained importance as a predictor .
CONCLUSIONS	Predictive value of screening measures for mental disorders may be specific in older age due to lower trait stability and age-specific psychometric limitations as well as age-related changes in relevant predictors .

###24824633
OBJECTIVE	To compare the effects of vildagliptin with those of glimepiride on glycaemic control , fat tolerance and inflammatory markers in people with Type 2 diabetes mellitus receiving metformin treatment .
METHODS	A total of 167 participants were randomized to vildagliptin 50mg twice a day or glimepiride 2mg three times a day , for 6months .
METHODS	We evaluated the following variables : BMI ; glycaemic control ; fasting plasma insulin ; homeostatic model assessment of insulin resistance index ; fasting plasma proinsulin ; glucagon ; lipid profile ; adiponectin ; high-sensitivity C-reactive protein ; interleukin-6 ; and tumour necrosis factor - .
METHODS	A euglycaemic-hyperinsulinaemic clamp procedure and an oral fat load test were also performed .
RESULTS	Despite a similar decrease in HbA1c levels ( P = 0.009 , and P = 0.008 , respectively ) , body weight increased with glimepiride ( P = 0.048 vs baseline ) and decreased with vildagliptin ( P = 0.041 vs baseline and vs glimepiride ) .
RESULTS	Fasting plasma insulin and homeostatic model assessment of insulin resistance index were significantly lower with vildagliptin compared with glimepiride ( P = 0.035 and 0.047 ) .
RESULTS	M value , an index of insulin sensitivity , increased with vildagliptin , both compared with baseline and with glimepiride ( P = 0.028 and 0.039 , respectively ) .
RESULTS	Vildagliptin improved all post-oral fat load peaks of lipid profile compared with glimepiride .
RESULTS	Adiponectin levels were higher ( P = 0.035 ) and high-sensitivity C-reactive protein levels were lower ( P = 0.038 ) with vildagliptin vs glimepiride .
RESULTS	During the oral fat load test , interleukin-6 , high-sensitivity C-reactive protein and tumour necrosis factor - peaks were lower and adiponectin peak was higher in the vildagliptin group than in the glimepiride group .
RESULTS	There was a higher dropout rate as a result of hypoglycaemia in the glimepiride group than in the vildagliptin group .
CONCLUSIONS	Vildagliptin was more effective than glimepiride in reducing post-oral fat load peaks of lipid-trafficking adipocytokines and inflammatory markers .

###25433837
BACKGROUND	Congenital cytomegalovirus ( CMV ) is the most common congenital infection in the U.S. and can result in permanent disabilities , such as hearing and vision loss , intellectual disability , and psychomotor and language impairments .
BACKGROUND	Women can adopt prevention behaviors in an attempt to reduce their exposure to CMV .
BACKGROUND	Currently , few women are familiar with CMV .
BACKGROUND	To increase awareness of CMV , the Centers for Disease Control and Prevention ( CDC ) developed draft health education materials .
BACKGROUND	The purpose of this study was to pilot test two health education materials to gauge their appeal and to determine if they increase knowledge about CMV and motivate audiences to seek additional information on CMV and adopt CMV prevention behaviors .
METHODS	African-American ( n = 404 ) and Caucasian women ( n = 405 ) , who had a young child and were either pregnant or planning a pregnancy , were recruited to participate in a 15-minute web survey .
METHODS	Participants were randomly assigned to view one of two CMV health education materials , either a factsheet or video .
METHODS	Pre and post survey measures were used to assess changes in knowledge of CMV and motivation to adopt prevention behaviors .
METHODS	We also examined audience preferences regarding materials and motivation .
RESULTS	CMV knowledge score increased significantly after presentation of either the video or factsheet ( from 3.7 out of 10 to 9.1 out of 10 , p < 0.001 ) .
RESULTS	The average materials appeal score was high , with a mean of 3.6 on a four-point scale , indicating women responded very positively to both materials .
RESULTS	Regression analyses indicated that appeal , message involvement ( e.g. , information seeking , discussing with others ) , post materials knowledge score , and viewing the video ( vs. factsheet ) were significantly positively associated with increased support for CMV prevention behaviors .
CONCLUSIONS	Overall , we found that the health education materials improved women 's knowledge of CMV and encouraged them to adopt prevention behaviors .
CONCLUSIONS	Given the low awareness levels among women currently , these findings suggest that appropriate education materials have the potential to greatly increase knowledge of CMV .
CONCLUSIONS	As women become more knowledgeable about CMV and transmission routes , we expect they will be more likely to adopt prevention behaviors , thereby reducing their risk of CMV infection .

###24595224
OBJECTIVE	Prospective studies have shown an inverse relationship between whole grain consumption and the risk of type 2 diabetes , where short chain fatty acids ( SCFA ) may be involved .
OBJECTIVE	Our objective was to determine the effect of isolated arabinoxylan alone or in combination with whole grain rye kernels on postprandial glucose , insulin , free fatty acids ( FFA ) , gut hormones , SCFA and appetite in subjects with the metabolic syndrome ( MetS ) .
METHODS	Fifteen subjects with MetS participated in this acute , randomised , cross-over study .
METHODS	The test meals each providing 50g of digestible carbohydrate were as follows : semolina porridge added concentrated arabinoxylan ( AX ) , rye kernels ( RK ) or concentrated arabinoxylan combined with rye kernels ( AXRK ) and semolina porridge as control ( SE ) .
METHODS	A standard lunch was served 4h after the test meals .
METHODS	Blood samples were drawn during a 6-h period , and appetite scores and breath hydrogen were assessed every 30min .
RESULTS	The AXRK meal reduced the acute glucose ( P = 0.005 ) and insulin responses ( P < 0.001 ) and the feeling of hunger ( P = 0.005 ; 0-360min ) compared with the control meal .
RESULTS	The AX and AXRK meals increased butyrate and acetate concentrations after 6h .
RESULTS	No significant differences were found for the second meal responses of glucose , insulin , FFA , glucagon-like peptide-1 or ghrelin .
CONCLUSIONS	Our results indicate a stimulatory effect of arabinoxylan on butyrate and acetate production , however , with no detectable effect on the second meal glucose response .
CONCLUSIONS	It remains to be tested in a long-term study if a beneficial effect on the glucose response of the isolated arabinoxylan will be related to the SCFA production .

###24661836
BACKGROUND	Fibre-rich rye products have been shown to have superior effects on self-reported appetite compared to white wheat bread and some studies have shown lower energy intake after subsequent meal .
BACKGROUND	The aim of the present study was to evaluate the effects of whole grain rye crisp bread ( RB ) versus refined wheat bread ( WB ) on appetite in two studies using different portion sizes and total energy intakes .
METHODS	Two randomised cross-over pre-load studies were conducted in 20 and 21 subjects , respectively .
METHODS	Appetite was rated by visual analogue scale ( VAS ) for 4 h.
METHODS	In both studies , participants were 39 14 years old and had BMI 23 3 .
METHODS	The studies differed in terms of energy content of the breakfasts and proportion of energy from the treatment product as well as amount of test products .
METHODS	Differences between treatments within the two studies were evaluated using mixed models with repeated measures appropriate for cross-over designs .
RESULTS	In Study one , hunger and desire to eat were significantly lower ( P < 0.05 ) after RB compared with WB , but there were no difference for fullness or difference in energy intake at lunch served ad libitum .
RESULTS	In Study two , the portion size was lower than in Study one and the test product constituted a larger proportion of the breakfast .
RESULTS	Fullness was significantly higher after RB compared with WB ( P < 0.05 ) and hunger , desire to eat as well as energy intake at lunch were significantly lower ( P < 0.05 ) .
CONCLUSIONS	Whole grain rye crisp bread caused lower self-reported hunger , higher fullness and less desire to eat compared to refined wheat bread .
CONCLUSIONS	It also led to a lower energy intake after an ad libitum lunch .
CONCLUSIONS	Results were stronger and/or more consistent when the test meal portion was smaller and accounted for a larger proportion of the total energy intake of the breakfast .

###24296848
OBJECTIVE	To determine the occurrence of extremely low HDL cholesterol ( HDL-C ) among participants in the Action to Control Cardiovascular Risk in Diabetes ( ACCORD ) Lipid Trial and to examine the relationship of this finding with treatment with fenofibrate and thiazolidinedione ( TZD ) .
METHODS	The ACCORD Lipid Trial was a randomized , double-blind , placebo-controlled study conducted in patients with type 2 diabetes at 77 clinical centers across the U.S. and Canada in a 5,518-patient subset of the larger 10,251 ACCORD Glycemia Trial .
METHODS	Patients were enrolled from 11 January 2001 to 29 October 2005 and followed until the end of study visits between 1 March and 30 June 2009 .
METHODS	Follow-up in the ACCORD Lipid Trial was 4-8 years ( mean 4.7 years ) .
METHODS	Patients were treated with blinded fenofibrate or placebo on a background of simvastatin therapy .
METHODS	The main outcome measures for these descriptive , post hoc analyses was the occurrence of extremely low HDL-C ( defined as < 25 mg/dL [ 0.647 mmol/L ] ) during the trial .
RESULTS	Among ACCORD Lipid Trial participants , the occurrence of extremely low HDL-C ever during study follow-up was 106 % higher among those randomized to fenofibrate ( 10.1 % fenofibrate vs. 4.9 % placebo , P < 0.001 ) .
RESULTS	The occurrence of low HDL-C was associated with concurrent treatment with fenofibrate and TZD ( 7.0 % for both vs. 2.2 % for neither at 48 months postrandomization ) .
CONCLUSIONS	Idiosyncratic and marked reduction in HDL-C can occur in some patients treated with both fenofibrate and TZD .
CONCLUSIONS	Practitioners should recognize this important potential idiosyncratic reaction and take appropriate corrective action .

###24629181
BACKGROUND	Osteoarthritis affecting the first metatarsophalangeal joint of the foot is a common condition which results in pain , stiffness and impaired ambulation .
BACKGROUND	Footwear modifications and foot orthoses are widely used in clinical practice to treat this condition , but their effectiveness has not been rigorously evaluated .
BACKGROUND	This article describes the design of a randomised trial comparing the effectiveness of rocker-sole footwear and individualised prefabricated foot orthoses in reducing pain associated with first metatarsophalangeal joint osteoarthritis .
METHODS	Eighty people with first metatarsophalangeal joint osteoarthritis will be randomly allocated to receive either a pair of rocker-sole shoes ( MBT Matwa , Masai Barefoot Technology , Switzerland ) or a pair of individualised , prefabricated foot orthoses ( Vasyli Customs , Vasyli Medical , Queensland , Australia ) .
METHODS	At baseline , the biomechanical effects of the interventions will be examined using a wireless wearable sensor motion analysis system ( LEGSys , BioSensics , Boston , MA , USA ) and an in-shoe plantar pressure system ( Pedar , Novel GmbH , Munich , Germany ) .
METHODS	The primary outcome measure will be the pain subscale of the Foot Health Status Questionnaire ( FHSQ ) , measured at baseline and 4 , 8 and 12 weeks .
METHODS	Secondary outcome measures will include the function , footwear and general foot health subscales of the FHSQ , severity of pain and stiffness at the first metatarsophalangeal joint ( measured using 100 mm visual analog scales ) , global change in symptoms ( using a 15-point Likert scale ) , health status ( using the Short-Form-12 Version 2.0 questionnaire ) , use of rescue medication and co-interventions to relieve pain , the frequency and type of self-reported adverse events and physical activity levels ( using the Incidental and Planned Activity Questionnaire ) .
METHODS	Data will be analysed using the intention to treat principle .
CONCLUSIONS	This study is the first randomised trial to compare the effectiveness of rocker-sole footwear and individualised prefabricated foot orthoses in reducing pain associated with osteoarthritis of the first metatarsophalangeal joint , and only the third randomised trial ever conducted for this condition .
CONCLUSIONS	The study has been pragmatically designed to ensure that the findings can be implemented into clinical practice if the interventions are found to be effective , and the baseline biomechanical analysis will provide useful insights into their mechanism of action .
BACKGROUND	Australian New Zealand Clinical Trials Registry : ACTRN12613001245785 .

###24754065
OBJECTIVE	To analyze the impact of a home exercise training ( ET ) program on quality of life , motor activity ( MA ) , dietary habit , functional and biochemical parameters , and clinical course of the disease in patients who have experienced acute coronary syndrome ( ACS ) and/or endovascular coronary intervention ( ECI ) .
METHODS	The trial included 100 patients after ECL who were randomized into 2 groups : those who had gone through Patient School ( PS ) and received a 6-week course of controlled ET ( a study group ( Group S ) ) and those who had gone through PS only ( a control group ( Group C ) .
METHODS	The patients of both groups were recommended a home ET program and , according to its implementation , they formed 2 subgroups : Subgroup A ( home ET + ) comprising 51 patients who had trained themselves at home ) and Subgroup B ( home ET - ) consisting of 46 patients who had not .
METHODS	The follow-up lasted 1 year .
METHODS	Quality of life , risk factors , lifestyle and clinical parameters were assessed .
RESULTS	As time elapsed , the patients ' motivation to perform home ET ; and , accordingly , the proportion of those who had trained themselves decreased in Group S to 67 and 61 % and in Group C to 39 and 40 % after 6 and 12 months , respectively .
RESULTS	Among the reasons for refusal to perform home ET , disease was reported by only 5.6 % of the patients ( by all from Group C ) .
RESULTS	The comprehensive physical rehabilitation program ( RP ) ( controlled ET in combination with home ET ) produced the best effect in raising the level of daily MA , exercise performance with a 21.3-fold increase in cardiac performance ( p < 0.05 ) and a 14.3-fold decrease in heart rate increment in response to exercises .
RESULTS	Group C patients who had refused the home ET program , as compared to those in the same group who had trained themselves at home , showed the worst daily MA levels , none body mass index reduction , and a rise in the low-density lipoprotein cholesterol ( by 20.3 % ; p < 0.05 ) and in the number of angina attacks ( by 1.9 times ; p < 0.05 ) .
CONCLUSIONS	RP in the early-stage , which encompasses an educational program ( PS ) , a short-term course of controlled ET and home ET used in patients with ACS , including in those after ECI , has clear clinical benefits .
CONCLUSIONS	The participation of patients with coronary heart disease ( CHD ) in the home ET programs increases their motivation and , hence , the proportion of those who participate in therapeutic and rehabilitation measures .
CONCLUSIONS	Home patient physical rehabilitation is one of the important components of different rehabilitation and prevention programs in patients with CHD after ACS and ECI .

###25644096
OBJECTIVE	Budesonide is a high-potency , second-generation corticosteroid designed to minimize systemic adverse consequences of conventional corticosteroids .
OBJECTIVE	We performed 2 randomized , phase 3 trials to evaluate the ability of budesonide rectal foam , formulated to optimize retention and provide uniform delivery of budesonide to the rectum and distal colon , to induce remission in patients with ulcerative proctitis or ulcerative proctosigmoiditis .
METHODS	Two identically designed , randomized , double-blind , placebo-controlled trials evaluated the efficacy of budesonide foam for induction of remission in 546 patients with mild to moderate ulcerative proctitis or ulcerative proctosigmoiditis who received budesonide foam 2 mg/25 mL twice daily for 2 weeks , then once daily for 4 weeks , or placebo .
RESULTS	Remission at week 6 occurred significantly more frequently among patients receiving budesonide foam than placebo ( Study 1 : 38.3 % vs 25.8 % ; P = .0324 ; Study 2 : 44.0 % vs 22.4 % ; P < .0001 ) .
RESULTS	A significantly greater percentage of patients receiving budesonide foam vs placebo achieved rectal bleeding resolution ( Study 1 : 46.6 % vs 28.0 % ; P = .0022 ; Study 2 : 50.0 % vs 28.6 % ; P = .0002 ) and endoscopic improvement ( Study 1 : 55.6 % vs 43.2 % ; P = .0486 ; Study 2 : 56.0 % vs 36.7 % ; P = .0013 ) at week 6 .
RESULTS	Most adverse events occurred at similar frequencies between groups , although events related to changes in cortisol values were reported more frequently with budesonide foam .
RESULTS	There were no cases of clinically symptomatic adrenal insufficiency .
CONCLUSIONS	Budesonide rectal foam was well tolerated and more efficacious than placebo in inducing remission in patients with mild to moderate ulcerative proctitis and ulcerative proctosigmoiditis .
CONCLUSIONS	ClinicalTrials.gov ID : NCT01008410 and NCT01008423 .

###25045795
OBJECTIVE	Flexible cystoscopy is a common practice in urology .
OBJECTIVE	We wanted to determine whether a retention time of 5 minutes between the administration of a local anesthetic lubricant and flexible cystoscope insertion decreased the degree of discomfort or pain in the patient .
METHODS	Males who underwent flexible cystoscopy during 5 months were randomized in a prospective study .
METHODS	They were divided into two groups .
METHODS	In the first one , the Cathejell lubricant with lidocaine 12.5 g was administered and cystoscopy was performed immediately .
METHODS	In the second one , the same lubricant was maintained in the urethra for 5 minutes before the performance of cystoscopy .
METHODS	After scanning , all the patients were requested to indicate the degree of perceived pain on a visual pain scale from 0 to 10 , with 0 being no discomfort and 10 being the maximum degree of pain bearable .
METHODS	As a secondary objective , the relationship of pain to age and to the type of cystoscopist ( urologist/resident doctor ) was studied .
METHODS	For statistical analysis , a Student 's t-test for independent samples and correlation analysis were used .
RESULTS	A total of 242 patients were studied , 110 in the immediate group and 132 in the 5-minute delay group , with samples being homogeneous for the age and type of cystoscopist .
RESULTS	The mean in the pain scale in the immediate group was 2.41 , and in the 5-minute delay group was 2.04 , with no significant differences between them ( p = 0.175 ) .
RESULTS	There was no relationship with age ( r = -0.061 , p = 0.348 ) or with the type of cystoscopist ( 2.06 of average pain in the associate group , 2.35 in the resident , p = 0.28 ) .
CONCLUSIONS	There is no benefit in waiting a short time after the administration of intraurethral lubrication with a local anesthetic in flexible cystoscopy in men .
CONCLUSIONS	There is also no relationship between the patient age or the type of cystoscopist ( urologist/resident doctor ) and perceived pain .

###25147125
BACKGROUND	Bariatric patients seeking information meet very different recommendations on postoperative diet and eating behaviour .
BACKGROUND	A reason for variability may be lack of hard evidence .
BACKGROUND	A national survey on current dietary advice was conducted to serve as background for the present study on how drinking during a meal influenced caloric consumption .
METHODS	A standardised questionnaire was sent to all units in the Scandinavian Obesity surgery registry ( SOReg ) in order to obtain information regarding current diet advice after gastric bypass .
METHODS	Twenty-eight patients , 14 in each group , were studied either 2 months or 1 year after a standard gastric bypass ( GBP ) .
METHODS	A standardised lunch was served on two separate days with or without water in randomised order .
METHODS	Meal and water weights were measured before and after .
METHODS	Hunger/satiety scores were obtained using visual analogue scales .
RESULTS	Response rate for surgeons was low , for dieticians 75 % .
RESULTS	No clear consensus for liquid intake during meals was found ; few surgeons advised patients whether or not to drink with meals .
RESULTS	All patients ate to full satiety .
RESULTS	Two months post-GBP , 7/14 patients consumed more solid food when allowed drinking water ; the increase in caloric consumption was not significant .
RESULTS	One year post-GBP , 5/14 patients consumed more solid food when allowed drinking water , the difference not reaching statistical significance .
CONCLUSIONS	Our study does not indicate that patients should refrain from drinking during meals the first year after a GBP , at least not from a caloric intake point of view .

###25247033
BACKGROUND	Ultrasound-guided nerve blocks ( UGNB ) are increasingly used in emergency care .
BACKGROUND	The hand-on-syringe ( HS ) needle technique is ideally suited to the emergency department setting because it allows a single operator to perform the block without assistance .
BACKGROUND	The HS technique is assumed to provide less exact needle control than the alternative two-operator hand-on-needle ( HN ) technique ; however this assumption has never been directly tested .
BACKGROUND	The primary objective of this study was to compare accuracy of needle targeting under ultrasound guidance by emergency medicine ( EM ) residents using HN and HS techniques on a standardized gelatinous simulation model .
METHODS	This prospective , randomized study evaluated task performance .
METHODS	We compared needle targeting accuracy using the HN and HS techniques .
METHODS	Each participant performed a set of structured needling maneuvers ( both simple and difficult ) on a standardized partial-task simulator .
METHODS	We evaluated time to task completion , needle visualization during advancement , and accuracy of needle tip at targeting .
METHODS	Resident technique preference was assessed using a post-task survey .
RESULTS	We evaluated 60 tasks performed by 10 EM residents .
RESULTS	There was no significant difference in time to complete the simple model ( HN vs. HS , 18 seconds vs. 18 seconds , p = 0.93 ) , time to complete the difficult model ( HN vs. HS , 56 seconds vs. 50 seconds , p = 0.63 ) , needle visualization , or needle tip targeting accuracy .
RESULTS	Most residents ( 60 % ) preferred the HS technique .
CONCLUSIONS	For EM residents learning UGNBs , the HN technique was not associated with superior needle control .
CONCLUSIONS	Our results suggest that the single-operator HS technique provides equivalent needle control when compared to the two-operator HN technique .

###24785951
BACKGROUND	For women at risk of HIV-1 , effective contraception and effective HIV-1 prevention are global priorities .
METHODS	In a clinical trial of pre-exposure prophylaxis ( PrEP ) for HIV-1 prevention in HIV-1-serodiscordant couples , we estimated the effectiveness of hormonal contraceptives ( oral contraceptive pills , injectable depot medroxyprogesterone acetate , and hormonal implants ) for pregnancy prevention relative to no contraception among 1785 HIV-1-uninfected women followed up to 36 months .
METHODS	We compared the effectiveness of each method among women assigned PrEP versus placebo .
METHODS	Contraception was not required for participation , but was offered on-site and was recorded monthly ; incident pregnancy was determined by monthly urine testing .
RESULTS	For women using no contraception , overall pregnancy incidence was 15.4 % per year .
RESULTS	Women reporting oral contraceptive use had comparable pregnancy incidence to women using no contraception , and this lack of contraceptive effectiveness was similar for those assigned PrEP and placebo ( 17.7 and 10.0 % incidence per year , respectively ; P-value for difference in effect by PrEP use = 0.24 ) .
RESULTS	Women reporting injectable contraception had reduced pregnancy incidence compared to those reporting no contraception , which did not differ by arm ( PrEP 5.1 % , placebo 5.3 % per year ; P-value for difference = 0.47 ) .
RESULTS	Contraceptive effectiveness was highest among women using implants ( pregnancy incidence < 1 % per year in both arms ) .
CONCLUSIONS	PrEP had no adverse impact on hormonal contraceptive effectiveness for pregnancy prevention .
CONCLUSIONS	As seen previously in similar populations , women reporting contraceptive pill use had little protection from pregnancy , possibly due to poor adherence .
CONCLUSIONS	Injectable or implantable hormonal contraception and PrEP provide effective prevention for pregnancy and HIV-1 .

###25699349
OBJECTIVE	To investigate acute hypervolemic hemodilution effect on oxygen metabolism and blood pharmacokinetics in patients undergoing acute laparotomy during Induction of general anesthesia .
METHODS	Forty ASA I-II patients undergoing acute laparotomy were randomly divided into 2 groups ( n = 20 each ) : Patients of group A received Voluven 7 ml/kg in 20 mins before induction and 8 ml/kg after induction .
METHODS	Patients of group B received 6 ml/kg/h Plasmalyte A. Hemodynamic parameters MAP , HR and CVP were collected at 6 set points during the surgery : T1 : before AHH ; T2 : before anesthesia induction ; T3 : right intubation ; T4 : 10 min after intubation ; T5 : 20 min after intubation ; T6 : skin incision .
METHODS	Arterial and venous blood samples were taken for blood gas analysis and determination of lactic acid , Hb and Hct : T1 : before AHH , T2 : right after AHH , T3 : 0.5 h after AHH , T4 : l h after AHH .
METHODS	Arterial Oxygen Content ( Ca02 ) , Central Venous Oxygen Content ( Ccv02 ) and Oxygen Extraction Ratio ( ER02 ) were calculated .
RESULTS	The hemodynamic parameters were maintained within normal limits during operation in group A ( P < 0.05 ) .
RESULTS	CaO2 , CcvO2 , ERO2 and Lac between the two groups were no significant difference ( P > 0.05 ) .
RESULTS	Compared with T1 , CaO2/CcvO2 atT 2 ~ 4 reduced in both groups ( P < 0.05 ) .
RESULTS	Compared with group A , Hb and Hct in group B increased at T2 ~ 4 ( P < 0.05 ) .
CONCLUSIONS	Acute hypervolemic hemodilution in patients undergoing acute laparotomy during Induction of general anesthesia have some preventive hypotension effect , more conducive to the smooth blood pharmacokinetics ; Voluven induced expansion of applications is safe and effective , and has no effect on the body 's metabolic rate of oxygen .

###25000163
OBJECTIVE	To compare in a randomized controlled clinical trial ( RCT ) the application of the TheraBite ( TB ) Jaw Motion Rehabilitation System with a standard physical therapy ( PT ) exercise regimen for the treatment of myogenic temporomandibular disorder ( TMD ) .
METHODS	Myogenic TMD patients were randomized for the use of the TB device or for standard PT .
METHODS	Mandibular function was assessed with the mandibular function impairment questionnaire ( MFIQ ) .
METHODS	Pain was evaluated using a visual analog scale , and maximum inter-incisor ( mouth ) opening ( MIO ) was measured using the disposable TB range of motion scale .
RESULTS	Of the 96 patients randomized ( 46 TB , 50 standard PT exercises ) , 38 actually started with the TB device and 41 with the standard PT exercises .
RESULTS	After six-week follow-up , patients using the TB device reported a significantly greater functional improvement ( MFIQ score ) than the patients receiving regular PT exercises ( P = 0.0050 ) .
RESULTS	At 6 weeks , no significant differences in pain , and active or passive MIO were found between the two groups .
RESULTS	At 3 months , patients in both treatment groups did equally well , and showed a significant improvement in all parameters assessed .
CONCLUSIONS	This RCT on myogenic TMD treatment , comparing standard PT with passive jaw mobilization using the TheraBite Jaw Motion Rehabilitation System , shows that both treatment modalities are equally effective in relieving myogenic TMD symptoms , but that the use of the TB device has the benefit of achieving a significantly greater functional improvement within the first week of treatment .

###25711320
OBJECTIVE	Efforts are needed to improve informed consent of participants in research .
OBJECTIVE	The Strategic Timing of AntiRetroviral Therapy ( START ) study provides a unique opportunity to study the effect of length and complexity of informed consent documents on understanding and satisfaction among geographically diverse participants .
METHODS	Interested START sites were randomized to use either the standard consent form or the concise consent form for all of the site 's participants .
RESULTS	A total of 4473 HIV-positive participants at 154 sites world-wide took part in the Informed Consent Substudy , with consent given in 11 primary languages .
RESULTS	Most sites sent written information to potential participants in advance of clinic visits , usually including the consent form .
RESULTS	At about half the sites , staff reported spending less than an hour per participant in the consent process .
RESULTS	The vast majority of sites assessed participant understanding using informal nonspecific questions or clinical judgment .
CONCLUSIONS	These data reflect the interest of START research staff in evaluating the consent process and improving informed consent .
CONCLUSIONS	The START Informed Consent Substudy is by far the largest study of informed consent intervention ever conducted .
CONCLUSIONS	Its results have the potential to impact how consent forms are written around the world .

###24923476
OBJECTIVE	To evaluate the effect of different methods to convert magnetic resonance ( MR ) signal intensity ( SI ) to gadolinium concentration ( [ Gd ] ) on estimation and reproducibility of model-free and modeled hepatic perfusion parameters measured with dynamic contrast-enhanced ( DCE ) - MRI .
METHODS	In this Institutional Review Board ( IRB ) - approved prospective study , 23 DCE-MRI examinations of the liver were performed on 17 patients .
METHODS	SI was converted to [ Gd ] using linearity vs. nonlinearity assumptions ( using spoiled gradient recalled echo [ SPGR ] signal equations ) .
METHODS	The [ Gd ] vs. time curves were analyzed using model-free parameters and a dual-input single compartment model .
METHODS	Perfusion parameters obtained with the two conversion methods were compared using paired Wilcoxon test .
METHODS	Test-retest and interobserver reproducibility of perfusion parameters were assessed in six patients .
RESULTS	There were significant differences between the two conversion methods for the following parameters : AUC60 ( area under the curve at 60 s , P < 0.001 ) , peak gadolinium concentration ( Cpeak , P < 0.001 ) , upslope ( P < 0.001 ) , Fp ( portal flow , P = 0.04 ) , total hepatic flow ( Ft , P = 0.007 ) , and MTT ( mean transit time , P < 0.001 ) .
RESULTS	Our preliminary results showed acceptable to good reproducibility for all model-free parameters for both methods ( mean coefficient of variation [ CV ] range , 11.87-23 .7 % ) , except for upslope ( CV = 37 % ) .
RESULTS	Among modeled parameters , DV ( distribution volume ) had CV < 22 % with both methods , PV and MTT showed CV < 21 % and < 29 % using SPGR equations , respectively .
RESULTS	Other modeled parameters had CV > 30 % with both methods .
CONCLUSIONS	Linearity assumption is acceptable for quantification of model-free hepatic perfusion parameters while the use of SPGR equations and T1 mapping may be recommended for the quantification of modeled hepatic perfusion parameters .

###24861159
BACKGROUND	The effectiveness of two treatment approaches ( phonological therapy and articulation therapy ) for treatment of 14 children , aged 4 ; 0-6 ; 7 years , with phonologically based speech-sound disorder ( SSD ) has been previously analysed with severity outcome measures ( percentage of consonants correct score , percentage occurrence of phonological processes and phonetic inventory ) .
BACKGROUND	Considering that the ultimate goal of intervention for children with phonologically based SSD is to improve intelligibility , it is curious that intervention studies focusing on children 's phonology do not routinely use intelligibility as an outcome measure .
BACKGROUND	It is therefore important that the impact of interventions on speech intelligibility is explored .
OBJECTIVE	This paper investigates the effectiveness of the two treatment approaches ( phonological therapy and articulation therapy ) using intelligibility measures , both in single words and in continuous speech , as the primary outcome .
METHODS	Fourteen children with phonologically based SSD participated in the intervention .
METHODS	The children were randomly assigned to phonological therapy or articulation therapy ( seven children in each group ) .
METHODS	Two assessment methods were used for measuring intelligibility : a word identification task ( for single words ) and a rating scale ( for continuous speech ) .
METHODS	Twenty-one unfamiliar adults listened and judged the children 's intelligibility .
METHODS	Reliability analyses showed overall high agreement between listeners across both methods .
RESULTS	Significant improvements were noted in intelligibility in both single words ( paired t ( 6 ) = 4.409 , p = 0.005 ) and continuous speech ( asymptotic Z = 2.371 , p = 0.018 ) for the group receiving phonology therapy pre - to post-treatment , but no differences in intelligibility were found for those receiving the articulation therapy pre - to post-treatment , either for single words ( paired t ( 6 ) = 1.763 , p = 0.128 ) or continuous speech ( asymptotic Z = 1.442 , p = 0.149 ) .
CONCLUSIONS	Intelligibility measures were sensitive enough to show changes in the phonological therapy group but not in the articulation therapy group .
CONCLUSIONS	These findings emphasize the importance of using intelligibility as an outcome measure to complement the results obtained with other severity measures when exploring the effectiveness of speech interventions .
CONCLUSIONS	This study presents new evidence for the effectiveness of phonological therapy in improving intelligibility with children with SSD .

###24884578
BACKGROUND	Staphylococcus aureus bacteremia is a common infection associated with significant morbidity and mortality .
BACKGROUND	Telavancin is a bactericidal lipoglycopeptide active against Gram-positive pathogens , including methicillin-resistant S. aureus ( MRSA ) .
BACKGROUND	We conducted a randomized , double-blind , Phase 2 trial in patients with uncomplicated S. aureus bacteremia .
METHODS	Patients were randomized to either telavancin or standard therapy ( vancomycin or anti-staphylococcal penicillin ) for 14days .
METHODS	Continuation criteria were set to avoid complicated S. aureus bacteremia .
METHODS	The primary end point was clinical cure at 84days .
RESULTS	In total , 60 patients were randomized and 58 received 1 study medication dose ( all-treated ) , 31 patients fulfilled inclusion/exclusion and continuation criteria ( all-treated target [ ATT ] ) ( telavancin 15 , standard therapy 16 ) , and 17 patients were clinically evaluable ( CE ) ( telavancin 8 , standard therapy 9 ) .
RESULTS	Mean age ( ATT ) was 60years .
RESULTS	Intravenous catheters were the most common source of S. aureus bacteremia and ~ 50 % of patients had MRSA .
RESULTS	A similar proportion of CE patients were cured in the telavancin ( 88 % ) and standard therapy ( 89 % ) groups .
RESULTS	All patients with MRSA bacteremia were cured and one patient with MSSA bacteremia failed study treatment in each group .
RESULTS	Although adverse events ( AEs ) were more common in the telavancin ATT group ( 90 % vs. 72 % ) , AEs leading to drug discontinuation were similar ( 7 % ) in both treatment arms .
RESULTS	Potentially clinically significant increases in serum creatinine ( 1.5 mg/dl and at least 50 % greater than baseline ) were more common in the telavancin group ( 20 % vs. 7 % ) .
CONCLUSIONS	This study suggests that telavancin may have utility for treatment of uncomplicated S. aureus bacteremia ; additional studies are warranted .
CONCLUSIONS	( Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia ( ASSURE ) ; NCT00062647 ) .

###25112845
OBJECTIVE	To evaluate the effectiveness of sulodexide for the treatment of hard exudates ( HE ) in non-proliferative diabetic retinopathy ( NPDR ) .
METHODS	This was a randomized , placebo-controlled , multicenter trial involving 130 patients ( 65 for each group ) who had mild-to-moderate NPDR with macular HE .
METHODS	Participants were given a daily dose of either 50 mg sulodexide or a matching dose of placebo orally for 12 months .
METHODS	Main outcome measure was an improvement in HE defined as a decrease in severity by at least two grades on a 10-grade severity scale .
METHODS	This was evaluated by fundus photography over 12-month period .
RESULTS	The sulodexide group showed significantly greater improvement in HE severity than that shown by the placebo group ( 39.0 % vs. 19.3 % ; chi square , P = 0.005 ) .
RESULTS	Logistic regression analysis yielded an odds ratio of 2.790 ( 95 % confidence interval , 1.155-6 .743 ; P = 0.023 ) for the effect of treatment once adjustments were made for demographic , prognostic and disease confounders .
RESULTS	Intention to treat and per-protocol analysis yielded similar results .
RESULTS	Sulodexide 's safety was comparable to that of the placebo .
CONCLUSIONS	Oral sulodexide therapy over 12 months improved macular HE in patients with mild-to-moderate NPDR , without leading to detectable adverse events .
CONCLUSIONS	The study protocol was registered on clinicaltrial.gov under identifier NCT01295775 .

###24716680
BACKGROUND	Mineralocorticoid-receptor antagonists improve the prognosis for patients with heart failure and a reduced left ventricular ejection fraction .
BACKGROUND	We evaluated the effects of spironolactone in patients with heart failure and a preserved left ventricular ejection fraction .
METHODS	In this randomized , double-blind trial , we assigned 3445 patients with symptomatic heart failure and a left ventricular ejection fraction of 45 % or more to receive either spironolactone ( 15 to 45 mg daily ) or placebo .
METHODS	The primary outcome was a composite of death from cardiovascular causes , aborted cardiac arrest , or hospitalization for the management of heart failure .
RESULTS	With a mean follow-up of 3.3 years , the primary outcome occurred in 320 of 1722 patients in the spironolactone group ( 18.6 % ) and 351 of 1723 patients in the placebo group ( 20.4 % ) ( hazard ratio , 0.89 ; 95 % confidence interval [ CI ] , 0.77 to 1.04 ; P = 0.14 ) .
RESULTS	Of the components of the primary outcome , only hospitalization for heart failure had a significantly lower incidence in the spironolactone group than in the placebo group ( 206 patients [ 12.0 % ] vs. 245 patients [ 14.2 % ] ; hazard ratio , 0.83 ; 95 % CI , 0.69 to 0.99 , P = 0.04 ) .
RESULTS	Neither total deaths nor hospitalizations for any reason were significantly reduced by spironolactone .
RESULTS	Treatment with spironolactone was associated with increased serum creatinine levels and a doubling of the rate of hyperkalemia ( 18.7 % , vs. 9.1 % in the placebo group ) but reduced hypokalemia .
RESULTS	With frequent monitoring , there were no significant differences in the incidence of serious adverse events , a serum creatinine level of 3.0 mg per deciliter ( 265 mol per liter ) or higher , or dialysis .
CONCLUSIONS	In patients with heart failure and a preserved ejection fraction , treatment with spironolactone did not significantly reduce the incidence of the primary composite outcome of death from cardiovascular causes , aborted cardiac arrest , or hospitalization for the management of heart failure .
CONCLUSIONS	( Funded by the National Heart , Lung , and Blood Institute ; TOPCAT ClinicalTrials.gov number , NCT00094302 . )

###25168967
OBJECTIVE	To compare the effectiveness and safety of fentanyl with placebo as pre-emptive treatment for pain associated with turning in patients in intensive care units .
BACKGROUND	Turning is frequently a painful procedure in this setting .
BACKGROUND	Pre-emptive administration of supplementary analgesia may help decrease this pain .
BACKGROUND	However , medical literature on pre-emptive analgesia in these patients is scarce .
METHODS	A randomized , double-blind , controlled clinical trial .
METHODS	This study will assess the benefits and risks of pre-emptive analgesia with fentanyl compared with placebo on turning-associated pain .
METHODS	Eighty patients will be recruited from among those older than 18 years and needing mechanical ventilation for at least 24 hours .
METHODS	Pain intensity will be assessed using the Behavioral Pain Scale .
METHODS	Primary outcome will be pain intensity between the baseline and 30 minutes after turning , measured by the area under the curve of the pain scale scores .
METHODS	Secondary outcomes will be the usefulness of physiological parameters and the Bispectral Index to measure pain and the safety of pre-emptive fentanyl in turning .
METHODS	The study protocol was approved in February 2011 .
CONCLUSIONS	If pre-emptive fentanyl is more effective than placebo and reasonably safe , the results of the current study may change nursing attitude in managing turning in critically ill patients .
CONCLUSIONS	As a consequence , pain may be decreased during this nursing procedure .

###26281475
OBJECTIVE	To study the associations of baseline gamma-glutamyltransferase ( GGT ) and alanine transaminase ( ALT ) with incident diabetes among Asian Indian men with impaired glucose tolerance ( IGT ) .
METHODS	In a 2 year prospective , randomised , controlled primary prevention study of diabetes , among 537 IGT men aged 35-55 years , 123 incident diabetes ( DM ) cases occurred .
METHODS	Anthropometric { body mass index ( BMI ) , waist circumference ( WC ) } , and laboratory measurements ( fasting , 30 min and 2 hr plasma glucose ( 2 hr PG ) , HbA1c and plasma insulin , lipid profile , ALT , GGT ) were estimated at baseline ( Clinical Trial Identification No : NCT00819455 ) .
METHODS	Predictive associations of baseline GGT and ALT values during the study were assessed using appropriate statistical methods .
RESULTS	Baseline GGT but not ALT was significantly higher in incident diabetes cases .
RESULTS	Mean ( 95 % CI ) GGT decreased in subjects who reverted to normal glucose tolerance ( NGT ) , whereas it increased in subjects who deteriorated to diabetes ( NGT : -3.5 ( -6.4 to -0.6 ) ; IGT :0.3 ( -3.0 to 2.4 ) ; DM :8.3 ( 3.6 to 13.0 ) UL ( -1 ) ; P < 0.0001 ) .
RESULTS	The risk of DM significantly increased with increasing baseline GGT after adjusting for confounders such as BMI , alcohol drinking , 2 hr PG and insulin resistance ( 2.02 [ 1.35-3 .02 ] ; P = 0.001 ) .
RESULTS	Receiver operating characteristic curve showed that the model comprising of baseline fasting plasma glucose ( FPG ) and GGT ( area-under-curve ( AUC ) [ 95 % CI ] : 0.668 [ 0.613-0 .722 ] ; P < 0.0001 ) was equally sensitive in identifying subjects with risk of diabetes as compared to 2 hr PG ( AUC [ 95 % CI ] : 0.670 [ 0.614-0 .725 ] ; P < 0.0001 ) and HbA1c ( AUC [ 95 % CI ] : 0.677 [ 0.619-0 .734 ] ; P < 0.0001 ) alone .
CONCLUSIONS	GGT was an independent predictor of incident diabetes .
CONCLUSIONS	Combination of GGT and FPG offers a simple and sensitive tool to identify subjects at high risk of developing diabetes .

###24238943
OBJECTIVE	To compare posterior capsule opacification ( PCO ) with 3 intraocular lenses ( IOLs ) 12 years postoperatively .
METHODS	St. Erik Eye Hospital , Stockholm , Sweden .
METHODS	Randomized clinical trial .
METHODS	Patients having unilateral standard phacoemulsification were randomized to implantation of a round-edged heparin-surface-modified ( HSM ) poly ( methyl methacrylate ) ( PMMA ) IOL , a round-edged silicone IOL , or a sharp-edged hydrophobic acrylic IOL .
METHODS	The neodymium : YAG ( Nd : YAG ) capsulotomy rates and timing from surgery were recorded .
METHODS	Survival analysis was used to compare Nd : YAG rates .
METHODS	Retroillumination images were taken to evaluate PCO .
RESULTS	After 12 years , there was no significant difference in the fraction or severity of PCO between the silicone IOL and acrylic IOL .
RESULTS	The HSM PMMA IOL had a significantly higher PCO fraction than the silicone IOL ( P < .05 ) , but not more than the acrylic IOL .
RESULTS	There was no difference in PCO severity between the HSM PMMA IOL and the other 2 IOLs .
RESULTS	The silicone IOL had higher median capsulotomy-free survival ( > 150 months ) than the acrylic IOL ( 108 months ) and the HSM PMMA IOL ( 53 months ) .
RESULTS	Overall survival without Nd : YAG capsulotomy did not differ between the acrylic and silicone IOLs or between the silicone and HSM PMMA IOLs ; however , overall survival was significantly better with the acrylic IOL than with the HSM PMMA IOL ( P < .001 ) .
CONCLUSIONS	After 12 years , there was no difference in PCO or overall survival without capsulotomy between the acrylic IOL and the silicone IOL .
CONCLUSIONS	The HSM PMMA IOL had a significantly higher PCO fraction than the silicone IOL and lower overall survival than the acrylic IOL .

###25309087
OBJECTIVE	To identify an appropriate therapeutic regimen for using aconite cake-separated moxibustion to treat diarrhea-predominant irritable bowel syndrome ( D-IBS ) .
METHODS	A factorial design was employed to examine the two factors of moxibustion frequency and number of cones .
METHODS	The two tested frequencies were three or six moxibustion sessions per week , and the two tested doses were one or two cones per treatment .
METHODS	A total of 166 D-IBS patients were randomly divided into four treatment groups , which included each combination of the examined frequencies and doses .
METHODS	The bilateral Tianshu acupoints ( ST25 ) and the Qihai acupoint ( RN6 ) were selected for aconite cake-separated moxibustion .
METHODS	Each patient received two courses of treatment , and each course had a duration of 2 wk .
METHODS	For each group , the scores on the Birmingham irritable bowel syndrome ( IBS ) symptom questionnaire , the IBS Quality of Life scale , the Self-Rating Depression Scale ( SDS ) , the Self-Rating Anxiety Scale ( SAS ) , the Hamilton Depression ( HAMD ) scale , and the Hamilton Anxiety ( HAMA ) scale were determined before treatment , after the first course of treatment , and after the second course of treatment .
RESULTS	The symptom , quality of life , SDS , SAS , HAMD , and HAMA scores of the patients in all 4 aconite cake-separated moxibustion groups were significantly lower after the first and second courses of treatment than before treatment ( P < 0.001 for all ) .
RESULTS	The symptom , quality of life , SDS , SAS , HAMD , and HAMA scores of the patients in all four aconite cake-separated moxibustion groups were significantly lower after the second course of treatment than after the first course of treatment ( P < 0.001 for all ) .
RESULTS	Between-group comparisons after the second course of treatment revealed that the symptom scores for group 1 ( 1 cone , 3 treatments/wk ) and group 3 ( 2 cones , 3 treatments/wk ) were significantly lower than that for group 2 ( 1 cone , 6 treatments/wk ) ( 5.55 5.05 vs 10.45 6.61 , P < 0.001 ; 5.65 4.00 vs 10.45 6.61 , P < 0.001 ) .
RESULTS	Regarding the two levels of the two examined factors for aconite cake-separated moxibustion , after the first course of treatment , the changes in HAMA scores were significantly different for the two tested moxibustion frequencies ( P = 0.011 ) , with greater changes for the `` 6 treatments/wk '' groups than for the `` 3 treatments/wk '' groups ; in addition , there were interaction effects between the number of cones and moxibustion frequency ( P = 0.028 ) .
RESULTS	After the second course of treatment , changes in symptom scores for the 2 tested moxibustion frequencies were significantly different ( P = 0.002 ) , with greater changes for the `` 3 treatments/wk '' groups than for the `` 6 treatments/wk '' groups .
CONCLUSIONS	An aconite cake-separated moxibustion treatment regimen of 3 treatments/wk and 1 cone/treatment appears to produce better therapeutic effects for D-IBS compared with the other tested regimens .

###24417601
OBJECTIVE	We sought to examine predictors and moderators of treatment outcomes among 488 youths ages 7-17 years ( 50 % female ; 74 % 12 years ) meeting Diagnostic and Statistical Manual of Mental Disorders ( 4th ed. , text rev. ; American Psychiatric Association , 2000 ) criteria for diagnoses of separation anxiety disorder , social phobia , or generalized anxiety disorder who were randomly assigned to receive either cognitive behavioral therapy ( CBT ) , sertraline ( SRT ) , their combination ( COMB ) , or medication management with pill placebo ( PBO ) in the Child/Adolescent Anxiety Multimodal Study ( CAMS ) .
METHODS	Six classes of predictor and moderator variables ( 22 variables ) were identified from the literature and examined using continuous ( Pediatric Anxiety Ratings Scale ; PARS ) and categorical ( Clinical Global Impression Scale-Improvement ; CGI-I ) outcome measures .
RESULTS	Three baseline variables predicted better outcomes ( independent of treatment condition ) on the PARS , including low anxiety severity ( as measured by parents and independent evaluators ) and caregiver strain .
RESULTS	No baseline variables were found to predict Week 12 responder status ( CGI-I ) .
RESULTS	Participants ' principal diagnosis moderated treatment outcomes but only on the PARS .
RESULTS	No baseline variables were found to moderate treatment outcomes on Week 12 responder status ( CGI-I ) .
CONCLUSIONS	Overall , anxious children responded favorably to CAMS treatments .
CONCLUSIONS	However , having more severe and impairing anxiety , greater caregiver strain , and a principal diagnosis of social phobia were associated with less favorable outcomes .
CONCLUSIONS	Clinical implications of these findings are discussed .

###26158178
OBJECTIVE	Emerging evidence has shown that epidural anesthesia could reduce the excessive stress response after surgery , and may help to preserve the body 's defenses against tumor progression in comparison with general anesthesia in malignant patients receiving operation .
OBJECTIVE	This study aims to evaluate the effect of epidural anesthesia on postoperative immune suppression in gastric cancer patients undergoing radical resection .
METHODS	Seventy one gastric cancer patients receiving radical resection were randomized to combined general/epidural anesthesia ( study group ) or general anesthesia alone ( control group ) .
METHODS	Natural killer cell activity and serum concentrations of protumorigenic cytokines IL-1 and IL-6 , and antitumorigenic cytokines IL-2 and IL-10 were measured before anesthesia ( T1 ) , 4h after skin incision ( T2 ) , and 24h after skin incision ( T3 ) in both groups .
RESULTS	In both groups , the concentrations of IL-10 , IL-6 , and IL-10 increased at T2 and T3 when compared with T1 , whereas IL-2 concentration and NK cell activity decreased at T2 and T3 .
RESULTS	Furthermore , the study group exhibited less suppression of NK cell activity , higher levels of IL-2 and IL-10 , and lower levels of IL-1 and IL-6 in the early stage after operation , compared with the control group .
RESULTS	CONCLUSIOns : Combined general/epidural anesthesia seems to helpful to maintain the body 's perioperative immune function compared to general anesthesia alone in patients with gastric cancer operation .

###24421638
OBJECTIVE	The aim of this study was to evaluate the effects of a telephone-based self-care intervention among urban living individuals 75 + years of age by comparing self-reported perceived health , mental health , sense of coherence , self-care ability , and self-care agency before and after the intervention .
METHODS	In a randomized controlled study , 15 persons answered a questionnaire about perceived health , mental health , sense of coherence , self-care ability , and self-care agency .
METHODS	In a sex - and age-matched control group ( n = 15 ) , the same questions were answered .
METHODS	Data were collected before and after intervention .
METHODS	An open-ended question about experiences of the intervention was included in the last questionnaire .
METHODS	The intervention consisted of a first meeting with health professionals and additional five self-care telephone calls .
METHODS	The control group did not receive any intervention or attention except for the questionnaires .
METHODS	Descriptive statistics were used to describe the study group .
METHODS	To compare the intervention group and control group on nominal and ordinal levels , the McNemar test and the Wilcoxon signed-rank test , respectively , were chosen .
RESULTS	Thirty individuals ( 14 females and 16 males ) participated in the study , ranging in age between 75 and 93 years .
RESULTS	A significant difference was obtained in the intervention group regarding mental health .
RESULTS	Mental health improved significantly in the intervention group ( P = 0.037 ) .
RESULTS	In the control group , mental health , sense of coherence , self-care ability , and self-care agency showed worse outcome results after the intervention ( 19 weeks ) .
CONCLUSIONS	Self-care telephone talks improved mental health significantly in our sample , and mental health focus could be understood as a possible condition for health promotion to take place .
CONCLUSIONS	Structured self-care telephone talks have proved to be successful and a relevant method to use in practice .

###24405800
OBJECTIVE	To explore and detail clinical experiences of dabigatran , a novel anticoagulant , after it became available in New Zealand in July 2011 .
METHODS	A cohort of patients was recruited from Hutt Hospital and the two largest primary care practices in the Hutt Valley region .
METHODS	They were included if they took at least one dose of dabigatran between July 2011 and April 2012 .
METHODS	Participants undertook a questionnaire 3-12 months after starting dabigatran assessing adherence , perceived side-effects and complications .
METHODS	Those presenting due to an adverse event were analysed separately .
RESULTS	Of 102 patients identified , 92 were recruited to this study .
RESULTS	At a median of 8 months , 70 % of participants were still taking dabigatran , significantly lower than in the RE-LY trial at 12 months ( P = 0.0002 ) .
RESULTS	The commonest reason given for discontinuation was gastrointestinal ( GI ) side-effects .
RESULTS	Rates of serious adverse outcomes on dabigatran therapy were relatively low .
RESULTS	Patients expressed polarised comments , both positive and negative , regarding their experiences of dabigatran .
CONCLUSIONS	A high rate of discontinuation of dabigatran , mainly due to GI symptoms , was observed .
CONCLUSIONS	There does not appear to be any specific predictor of dabigatran tolerance .
CONCLUSIONS	When prescribed according to guidelines , rates of serious adverse events associated with dabigatran appear to be low .

###25262260
BACKGROUND	Peak creatine kinase ( CK ) - MB concentration is related to reperfusion success and clinical outcomes after fibrinolytic therapy for acute myocardial infarction .
BACKGROUND	However , prognostic implications of CK-MB measurements after primary percutaneous coronary intervention ( PCI ) , which provides more predictable and consistent reperfusion , are unknown .
METHODS	We pooled 2,042 primary PCI-treated ST-segment elevation myocardial infarction ( STEMI ) patients from 3 trials with serial core laboratory-determined CK-MB measurements ; 1,799 patients ( 88.1 % ) who survived to 36 hours and had 4 CK-MB measurements were studied .
METHODS	Cox regression modeling was performed to quantify the association between peak CK-MB concentration ( and area under the time-concentration curve [ AUC ] ) and mortality at 6 months , and death or congestive heart failure at 90 days .
RESULTS	The median ( 25th-75th percentiles ) peak CK-MB concentration and AUC measurement through 36 hours were 239 ( 109-429 ) ng/mL and 4,263 ( 2,081-7 ,124 ) ng / ( mL h ) , respectively .
RESULTS	By multivariable analysis , peak CK-MB concentration and AUC measurement were independently associated with 6-month mortality ( adjusted hazard ratio [ HR ] 1.15 , 95 % CI 1.05-1 .25 , per 100-ng/mL increase , P = .002 ; and adjusted HR 1.09 , 95 % CI 1.03-1 .14 , per 1,000-ng / [ mL h ] increase , P < .001 , respectively ) and 90-day death or congestive heart failure ( adjusted HR 1.26 , 95 % CI 1.18-1 .34 , P < .001 ; and adjusted HR 1.15 , 95 % CI 1.11-1 .19 , P < .001 , respectively ) .
CONCLUSIONS	Peak CK-MB concentration and AUC measurement are independent predictors of 3 - to 6-month cardiovascular outcomes in primary PCI-treated STEMI patients .
CONCLUSIONS	Our findings guide application of these measurements as efficacy end points in early-phase studies evaluating new therapies for STEMI .

###24935757
OBJECTIVE	We conducted a pilot randomized trial of telephone-delivered acceptance and commitment therapy ( ACT ) versus cognitive behavioral therapy ( CBT ) for smoking cessation .
METHODS	Participants were 121 uninsured South Carolina State Quitline callers who were adult smokers ( at least 10 cigarettes/day ) and who wanted to quit within the next 30 days .
METHODS	Participants were randomized to 5 sessions of either ACT or CBT telephone counseling and were offered 2 weeks of nicotine replacement therapy ( NRT ) .
RESULTS	ACT participants completed more calls than CBT participants ( M = 3.25 in ACT vs. 2.23 in CBT ; p = .001 ) .
RESULTS	Regarding satisfaction , 100 % of ACT participants reported their treatment was useful for quitting smoking ( vs. 87 % for CBT ; p = .03 ) , and 97 % of ACT participants would recommend their treatment to a friend ( vs. 83 % for CBT ; p = .06 ) .
RESULTS	On the primary outcome of intent-to-treat 30-day point prevalence abstinence at 6 months postrandomization , the quit rates were 31 % in ACT versus 22 % in CBT ( odds ratio [ OR ] = 1.5 , 95 % confidence interval [ CI ] = 0.7-3 .4 ) .
RESULTS	Among participants depressed at baseline ( n = 47 ) , the quit rates were 33 % in ACT versus 13 % in CBT ( OR = 1.2 , 95 % CI = 1.0-1 .6 ) .
RESULTS	Consistent with ACT 's theory , among participants scoring low on acceptance of cravings at baseline ( n = 57 ) , the quit rates were 37 % in ACT versus 10 % in CBT ( OR = 5.3 , 95 % CI = 1.3-22 .0 ) .
CONCLUSIONS	ACT is feasible to deliver by phone , is highly acceptable to quitline callers , and shows highly promising quit rates compared with standard CBT quitline counseling .
CONCLUSIONS	As results were limited by the pilot design ( e.g. , small sample ) , a full-scale efficacy trial is now needed .

###25336467
BACKGROUND	In patients with severe aortic stenosis , transcatheter aortic valve replacement ( TAVR ) improves survival when compared with nonsurgical therapy but with higher in-hospital and lifetime costs .
BACKGROUND	Complications associated with TAVR may decrease with greater experience and improved devices , thereby reducing the overall cost of the procedure .
BACKGROUND	Therefore , we sought to estimate the effect of periprocedural complications on in-hospital costs and length of stay of TAVR .
RESULTS	Using detailed cost data from 406 TAVR patients enrolled in the Placement of Aortic Transcatheter Valve ( PARTNER ) I trial , we developed multivariable models to estimate the incremental cost and length of stay associated with specific periprocedural complications .
RESULTS	Attributable costs and length of stay for each complication were calculated by multiplying the independent cost of each event by its frequency in the treatment group .
RESULTS	Mean cost for the initial hospitalization was $ 79 61940 570 ( $ 50 891 excluding the valve ) ; 49 % of patients had 1 complication .
RESULTS	Seven complications were independently associated with increased hospital costs , with major bleeding , arrhythmia , and death accounting for the largest attributable cost per patient .
RESULTS	Renal failure and the need for repeat TAVR , although less frequent , were also associated with substantial incremental and attributable costs .
RESULTS	Overall , complications accounted for $ 12 475 per patient in initial hospital costs and 2.4 days of hospitalization .
CONCLUSIONS	In the PARTNER trial , periprocedural complications were frequent , costly , and accounted for 25 % of non-implant-related hospital costs .
CONCLUSIONS	Avoidance of complications should improve the cost-effectiveness of TAVR for inoperable and high-risk patients , but reductions in the cost of uncomplicated TAVR will also be necessary for optimal efficiency .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00530894 .

###25027701
BACKGROUND	In a recent study one third of Lao patients presenting with uncomplicated Plasmodium falciparum malaria had biochemical evidence of thiamin deficiency , which was associated with a higher incidence of adverse events .
BACKGROUND	Thiamin supplementation might , therefore , reduce adverse events in this population .
METHODS	An exploratory , double-blind , parallel group , placebo-controlled , superiority trial of thiamin supplementation in patients of all ages with uncomplicated and severe falciparum malaria was conducted in Xepon District , Savannakhet Province , southern Laos .
METHODS	Patients were randomly assigned to either oral thiamin 10 mg/day for 7 days immediately after standard anti-malarial treatment then 5 mg daily until day 42 , or identical oral placebo .
RESULTS	After interim analyses when 630 patients ( 314 in thiamin and 316 in placebo groups ) had been recruited , the trial was discontinued on the grounds of futility .
RESULTS	On admission biochemical thiamin deficiency ( alpha25 % ) was present in 27 % of patients and 9 % had severe deficiency ( alpha > 31 % ) .
RESULTS	After 42 days of treatment , the frequency of thiamin deficiency was lower in the thiamin ( 2 % , 1 % severe ) compared to the placebo ( 11 % , 3 % severe ) groups ( p < 0.001 and p = 0.05 ) , respectively .
RESULTS	Except for diarrhoea , 7 % in the placebo compared to 3 % in the thiamin group ( p = 0.04 ) , and dizziness on day 1 ( 33 % vs 25 % , p = 0.045 ) , all adverse events were not significantly different between the groups ( p > 0.05 ) .
RESULTS	Clinical , haematological , and parasitological responses to treatment did not differ significantly between the two groups .
CONCLUSIONS	Thiamin supplementation reduced biochemical thiamin deficiency among Lao malaria patients following anti-malarial drug treatment , but it did not reduce the frequency of adverse events after anti-malarial therapy or have any detected clinical or parasitological impact .
BACKGROUND	ISRCTN 85411059 .

###24594542
BACKGROUND	Chronic rhinosinusitis significantly impairs CF patients ' quality of life and overall health .
BACKGROUND	The Pari-Sinus device delivers vibrating aerosol effectively to paranasal sinuses .
BACKGROUND	After a small pilot study to assess sinonasal inhalation of dornase alfa and placebo ( isotonic saline ) on potential sinonasal outcome measures , we present the subsequent prospective double-blind placebo-controlled crossover-trial .
METHODS	23 CF patients were randomised to inhale either dornase alfa or isotonic saline for 28 days with the Pari-Sinus and after 28 days ( wash-out ) crossed over to the alternative treatment .
METHODS	The primary outcome parameter was primary nasal symptom score in the disease-specific quality of life Sino-Nasal Outcome-Test-20 ( SNOT-20 : nasal obstruction/sneezing/runny nose/thick nasal discharge/reduced smelling ) .
RESULTS	Primary nasal symptoms improved significantly with dornase alfa compared with no treatment , while small improvements with isotonic saline did not reach significance .
RESULTS	SNOT-20 overall scores improved significantly after dornase alfa compared with isotonic saline ( p = 0.017 ) .
RESULTS	Additionally , sinonasal dornase alfa but not isotonic saline significantly improved pulmonary function ( FEF75-25 : p = 0.021 ) .
CONCLUSIONS	Vibrating sinonasal inhalation of dornase alfa reduces rhinosinusitis symptoms in CF.

###25641537
OBJECTIVE	To determine the feasibility of conducting a randomized controlled trial comparing a low-sodium to a moderate-sodium diet in heart failure ( HF ) patients .
RESULTS	Patients with HF ( New York Heart Association classes II-III ) were randomized to low ( 1500 mg/d ) or moderate-sodium ( 2300 mg/d ) diet .
RESULTS	Dietary intake was evaluated using 3-day food records .
RESULTS	The end points were changes in quality of life as measured by the Kansas City Cardiomyopathy Questionnaire ( KCCQ ) scores and B-type natriuretic peptide ( BNP ) levels from baseline to 6 months of follow-up presented as medians [ 25th , 75th percentiles ] .
RESULTS	Thirty-eight patients were enrolled ( 19/group ) .
RESULTS	After 6 months , median sodium intake declined from 2137 to 1398 mg/d in the low-sodium and from 2678 to 1461 mg/d in the moderate-sodium diet group .
RESULTS	Median BNP levels in the low-sodium diet group declined ( 216-71 pg/mL , P = .006 ) , whereas in the moderate-sodium diet group , there was no change in BNP ( 171-188 pg/mL , P = .7 ; P = .17 between groups ) .
RESULTS	For 6 months , median KCCQ clinical score increased in both groups ( 63-75 [ P = .006 ] in the low-sodium diet group and 66-73 [ P = .07 ] in the moderate-sodium group ; P = .4 between groups ) .
RESULTS	At 6 months , a post hoc analysis based on the dietary sodium intake achieved ( > or 1,500 mg/d ) in all patients showed an association between a sodium intake 1,500 mg/d and improvement in BNP levels and KCCQ scores .
CONCLUSIONS	A dietary intervention restricting sodium intake was feasible , and achievement of this sodium goal was associated with lower BNP levels and improved quality of life in patients with HF .

###24595631
OBJECTIVE	The aim of this article was to define risk factors for incidence of peripheral arterial disease ( PAD ) in a large cohort of patients with type 2 diabetes mellitus ( T2DM ) , overall and within the context of differing glycemic control strategies .
METHODS	The Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes ( BARI 2D ) randomized controlled trial assigned participants to insulin-sensitizing ( IS ) therapy versus insulin-providing ( IP ) therapy .
METHODS	A total of 1,479 participants with normal ankle-brachial index ( ABI ) at study entry were eligible for analysis .
METHODS	PAD outcomes included new ABI 0.9 with decrease at least 0.1 from baseline , lower extremity revascularization , or lower extremity amputation .
METHODS	Baseline risk factors within the overall cohort and time-varying risk factors within each assigned glycemic control arm were assessed using Cox proportional hazards models .
RESULTS	During an average 4.6 years of follow-up , 303 participants ( 20.5 % ) experienced an incident case of PAD .
RESULTS	Age , sex , race , and baseline smoking status were all significantly associated with incident PAD in the BARI 2D cohort .
RESULTS	Additional baseline risk factors included pulse pressure , HbA1c , and albumin-to-creatinine ratio ( P < 0.05 for each ) .
RESULTS	In stratified analyses of time-varying covariates , changes in BMI , LDL , HDL , systolic blood pressure , and pulse pressure were most predictive among IS patients , while change in HbA1c was most predictive among IP patients .
CONCLUSIONS	Among patients with T2DM , traditional cardiovascular risk factors were the main predictors of incident PAD cases .
CONCLUSIONS	Stratified analyses showed different risk factors were predictive for patients treated with IS medications versus those treated with IP medications .

###24641783
OBJECTIVE	To investigate the effects on plaque index ( PI ) scores of manual or electric toothbrush with or without repeated oral hygiene instructions ( OHI ) and motivation on patients wearing fixed orthodontic appliances .
METHODS	One month after the orthodontic fixed appliance bonding on both arches , 60 patients were randomly assigned to four groups ; groups E1 ( n = 15 ) and E2 ( n = 15 ) received a powered rotating-oscillating toothbrush , and groups M1 ( n = 15 ) and M2 ( n = 15 ) received a manual toothbrush .
METHODS	Groups E1 and M1 received OHI and motivation at baseline ( T0 ) and after 4 , 8 , 12 , 16 , and 20 weeks ( T4 , T8 , T12 , T16 , and T20 , respectively ) by a Registered Dental Hygienist ; groups E2 and M2 received OHI and motivation only at baseline .
METHODS	At each time point a blinded examiner scored plaque of all teeth using the modified Quigley-Hein PI .
RESULTS	In all groups the PI score decreased significantly over time , and there were differences among groups at T8 , T12 , T16 , and T20 .
RESULTS	At T8 , PI scores of group E1 were lower than those of group E2 , and at T12 , T16 , and T20 , PI scores of groups M1 and E1 were lower compared to those of groups M2 and E2 .
RESULTS	A linear mixed model showed that the effect of repeated OHI and motivation during time was statistically significant , independently from the use of manual or electric toothbrush .
CONCLUSIONS	The present results showed that repeated OHI and motivation are crucial in reducing PI score in orthodontic patients , independent of the type of toothbrush used .

###24509454
BACKGROUND	Anastomotic complications , including leaks , strictures/stenoses , and bleeding , cause considerable mortality and morbidity after colorectal surgery .
OBJECTIVE	The aim of this study was to assess whether the use of a synthetic , bioabsorbable staple line reinforcement material with circular staplers would reduce postoperative anastomotic leakage in patients with a colorectal , coloanal , or ileoanal anastomosis .
METHODS	This was a randomized study that compared outcomes in patients in whom the reinforcement material was used with those in patients who were not given the material .
METHODS	This study was conducted at several centers in the United States .
METHODS	The 258 patients ( 123 in the reinforcement group and 135 control subjects ) underwent surgery for a variety of conditions , but most ( n = 200 ) were treated for rectal cancer .
METHODS	The main outcome measures were occurrence of anastomotic leaks and other complications according to the study protocol .
RESULTS	There were no significant differences in the 2 study groups with respect to age , BMI , ASA physical status , operating time , diagnosis , previous chemoradiotherapy , surgical technique , or 30-day complications , except for a higher rate of small-bowel obstruction ( p = 0.03 ) and anastomotic stricture ( p = 0.006 ) in the control group .
RESULTS	The overall anastomotic leak rate was 12 % ( bioabsorbable staple line reinforcement , 11.4 % ; no bioabsorbable staple line reinforcement , 12.6 % ) .
CONCLUSIONS	The study was nonblinded and was terminated at the first planned interim analysis because of insufficient power to detect an intergroup difference in anastomotic leak rate in the time allotted for the investigation .
CONCLUSIONS	Reinforcing the circular staple line in colorectal anastomoses with bioabsorbable material did not significantly affect the anastomotic leak rate but may have reduced anastomotic strictures .
CONCLUSIONS	Most strictures did not require an anastomotic revision or delay in stoma closure .
CONCLUSIONS	The bioabsorbable material may positively affect some aspects of the healing of circular stapled colorectal anastomoses ; however , additional research on factors associated with anastomotic leakage is needed .

###25605861
OBJECTIVE	To develop a genomic signature that predicts benefit from trastuzumab in human epidermal growth factor receptor 2-positive breast cancer .
METHODS	DASL technology was used to quantify mRNA in samples from 1,282 patients enrolled onto the Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer ( North Central Cancer Treatment Group N9831 [ NCCTG-N9831 ] ) adjuvant trastuzumab trial .
METHODS	Cox proportional hazard ratios ( HRs ) , adjusted for significant clinicopathologic risk factors , were used to determine the association of each gene with relapse-free survival ( RFS ) for 433 patients who received chemotherapy alone ( arm A ) and 849 patients who received chemotherapy plus trastuzumab ( arms B and C ) .
METHODS	Network and pathway analyses were used to identify key biologic processes linked to RFS .
METHODS	The signature was built by using a voting scheme .
RESULTS	Network and functional ontology analyses suggested that increased RFS was linked to a subset of immune function genes .
RESULTS	A voting scheme model was used to define immune gene enrichment based on the expression of any nine or more of 14 immune function genes at or above the 0.40 quantile for the population .
RESULTS	This model was used to identify immune gene-enriched tumors in arm A and arms B and C. Immune gene enrichment was linked to increased RFS in arms B and C ( HR , 0.35 ; 95 % CI , 0.22 to 0.55 ; P < .001 ) , whereas arm B and C patients who did not exhibit immune gene enrichment did not benefit from trastuzumab ( HR , 0.89 ; 95 % CI , 0.62 to 1.28 ; P = .53 ) .
RESULTS	Enriched immune function gene expression as defined by our predictive signature was not associated with increased RFS in arm A ( HR , 0.90 ; 95 % CI , 0.60 to 1.37 ; P = .64 ) .
CONCLUSIONS	Increased expression of a subset of immune function genes may provide a means of predicting benefit from adjuvant trastuzumab .

###25239537
OBJECTIVE	Finding current best evidence for clinical decisions remains challenging .
OBJECTIVE	With 3,000 new studies published every day , no single evidence-based resource provides all answers or is sufficiently updated .
OBJECTIVE	McMaster Premium LiteratUre Service -- Federated Search ( MacPLUS FS ) addresses this issue by looking in multiple high quality resources simultaneously and displaying results in a one-page pyramid with the most clinically useful at the top .
OBJECTIVE	Yet , additional logistical and educational barriers need to be addressed to enhance point-of-care evidence retrieval .
OBJECTIVE	This trial seeks to test three innovative interventions , among clinicians registered to MacPLUS FS , to increase the quantity and quality of searching for current best evidence to answer clinical questions .
METHODS	In a user-centered approach , we designed three interventions embedded in MacPLUS FS : ( A ) a web-based Clinical Question Recorder ; ( B ) an Evidence Retrieval Coach composed of eight short educational videos ; ( C ) an Audit , Feedback and Gamification approach to evidence retrieval , based on the allocation of ` badges ' and ` reputation scores . '
METHODS	We will conduct a randomized factorial controlled trial among all the 904 eligible medical doctors currently registered to MacPLUS FS at the hospitals affiliated with McMaster University , Canada .
METHODS	Postgraduate trainees ( n = 429 ) and clinical faculty/staff ( n = 475 ) will be randomized to each of the three following interventions in a factorial design ( AxBxC ) .
METHODS	Utilization will be continuously recorded through clinicians accounts that track logins and usage , down to the level of individual keystrokes .
METHODS	The primary outcome is the rate of searches per month per user during the six months of follow-up .
METHODS	Secondary outcomes , measured through the validated Impact Assessment Method questionnaire , include : utility of answers found ( meeting clinicians information needs ) , use ( application in practice ) , and perceived usefulness on patient outcomes .
CONCLUSIONS	Built on effective models for the point-of-care teaching , these interventions approach evidence retrieval as a clinical skill .
CONCLUSIONS	If effective , they may offer the opportunity to enhance it for a large audience , at low cost , providing better access to relevant evidence across many top EBM resources in parallel .
BACKGROUND	ClinicalTrials.Gov NCT02038439 .

###24260122
OBJECTIVE	To determine effects of probiotic consumption on clinical and immunological parameters of seasonal allergic rhinitis ( SAR ) in an out-of-season single nasal allergen challenge .
METHODS	In a study registered at ClinicalTrials.Gov ( NCT01123252 ) , a 16-week dietary intervention was undertaken in 60 patients with allergic rhinitis ( > 16 years old ) .
METHODS	Using a double-blinded , placebo-controlled anonymised design , the patients were divided equally into two groups .
METHODS	One group was given a dairy drink containing Lactobacillus casei Shirota to ingest daily while the other consumed a similar drink without bacteria .
METHODS	Participants attended the clinic on two consecutive days before the intervention and then again at the end of the study period .
METHODS	On the first day of each 2-day visit , following clinical examination , assessments were made of total nasal symptoms scores and peak nasal inspiratory flow .
METHODS	Nasal scrapings , nasal lavage and blood were collected for laboratory analyses of cellular phenotypes , soluble mediator release and in vitro responses to pollen allergen .
METHODS	These procedures were repeated 24 hours following nasal allergen challenge .
RESULTS	Prior to and following intervention there were no detectable differences between study groups in measured clinical outcome .
RESULTS	After intervention , there were differences between groups in their percentages of CD86 + epithelial cells ( p = 0.0148 ) , CD86 + CD252 + non-epithelial cells ( p = 0.0347 ) , sIL-1RII release ( p = 0.0289 ) and IL-1 ( p = 0.0224 ) levels at the nasal mucosa .
RESULTS	Delivery of probiotic also suppressed production of sCD23 ( p = 0.0081 ) , TGF - ( p = 0.0283 ) and induced increased production of IFN - ( p = 0.0351 ) in supernatants of cultured peripheral blood .
CONCLUSIONS	This study did not show significant probiotic-associated changes with respect to the primary clinical endpoint .
CONCLUSIONS	An absence of overt clinical benefit may be due to an inability of single nasal challenges to accurately represent natural allergen exposure .
CONCLUSIONS	Nevertheless , oral delivery of probiotics produced changes of the immunological microenvironment at the nasal mucosa in individuals affected by SAR .
BACKGROUND	ClinicalTrials.Gov NCT01123252 .

###25448247
OBJECTIVE	To assess the effects of patient-controlled abdominal compression on postural changes in systolic blood pressure ( SBP ) associated with orthostatic hypotension ( OH ) .
OBJECTIVE	Secondary variables included subject assessments of their preferences and the ease-of-use .
METHODS	Randomized crossover trial .
METHODS	Clinical research laboratory .
METHODS	Adults with neurogenic OH ( N = 13 ) .
METHODS	Four maneuvers were performed : moving from supine to standing without abdominal compression ; moving from supine to standing with either a conventional or an adjustable abdominal binder in place ; application of subject-determined maximal tolerable abdominal compression while standing ; and while still erect , subsequent reduction of abdominal compression to a level the subject believed would be tolerable for a prolonged period .
METHODS	The primary outcome variable included postural changes in SBP .
METHODS	Secondary outcome variables included subject assessments of their preferences and ease of use .
RESULTS	Baseline median SBP in the supine position was not affected by mild ( 10mmHg ) abdominal compression prior to rising ( without abdominal compression : 146mmHg ; interquartile range , 124-164mmHg ; with the conventional binder : 145mmHg ; interquartile range , 129-167mmHg ; with the adjustable binder : 153mmHg , interquartile range , 129-160mmHg ; P = .85 ) .
RESULTS	Standing without a binder was associated with an -57 mmHg ( interquartile range , -40 to -76 mmHg ) SBP decrease .
RESULTS	Levels of compression of 10mmHg applied prior to rising with the conventional and adjustable binders blunted these drops to -50 mmHg ( interquartile range , -33 to -70 mmHg ; P = .03 ) and -46 mmHg ( interquartile range , -34 to -75 mmHg ; P = .01 ) , respectively .
RESULTS	Increasing compression to subject-selected maximal tolerance while standing did not provide additional benefit and was associated with drops of -53 mmHg ( interquartile range , -26 to -71 mmHg ; P = .64 ) and -59 mmHg ( interquartile range , -49 to -76 mmHg ; P = .52 ) for the conventional and adjustable binders , respectively .
RESULTS	Subsequent reduction of compression to more tolerable levels tended to worsen OH with both the conventional ( -61 mmHg ; interquartile range , -33 to -80 mmHg ; P = .64 ) and adjustable ( -67 mmHg ; interquartile range , -61 to -84 mmHg ; P = .79 ) binders .
RESULTS	Subjects reported no differences in preferences between the binders in terms of preference or ease of use .
CONCLUSIONS	These results suggest that mild ( 10mmHg ) abdominal compression prior to rising can ameliorate OH , but further compression once standing does not result in additional benefit .

###24581576
OBJECTIVE	To compare the diagnostic accuracy of three-dimensional sonohysterography ( 3D-SIS ) and office hysteroscopy in uterine cavity assessment after hysteroscopic metroplasty ( HM ) and determine the interrater/intrarater agreement for 3D-SIS .
METHODS	Prospective observational study .
METHODS	University hospital , private hospital , and clinic .
METHODS	One hundred forty-one women undergoing HM for septate uterus with a history of miscarriage and/or infertility .
METHODS	3D-SIS and office hysteroscopy at 6-8 weeks after HM .
METHODS	Shape of the uterine cavity , length of the fundal notch ( 1 or < 1 cm ) , and the presence of intrauterine adhesions were assessed , and the interrater/intrarater agreement of 3D-SIS was evaluated in 30 randomly selected patients .
RESULTS	Uterine abnormalities were detected with the use of hysteroscopy in 18 ( 12.8 % ) of 141 women .
RESULTS	3D-SIS was highly accurate ( 97.2 % ) , sensitive ( 97 % ) , and specific ( 100 % ) , with a positive predictive value of 100 % and a negative predictive value of 85 % .
RESULTS	The diagnostic values of hysteroscopy and 3D-SIS were not significantly different ( McNemar test ) .
RESULTS	3D-SIS showed substantial interrater/intrarater agreement regarding overall uterine cavity evaluation ( = 0.79 and 0.78 , respectively ) .
CONCLUSIONS	3D-SIS demonstrated substantial interrater/intrarater agreement for the postoperative evaluation of the uterine cavity , being as diagnostically accurate as hysteroscopy .
CONCLUSIONS	The use of second-look hysteroscopy may be limited to cases that require reoperation .

###24585409
BACKGROUND	Obesity is associated with a higher risk of aggressive prostate cancer and alters circulating levels of insulin and adiponectin , two hormones that influence biologic processes implicated in carcinogenesis .
BACKGROUND	Results of some studies showed associations of circulating levels of adiponectin , insulin , and c-peptide ( a marker of insulin secretion ) with aggressive prostate cancer , but the size of these studies was limited .
METHODS	A nested case-control study of 272 aggressive prostate cancer cases [ Gleason score 7 ( 4 +3 ) or T3-T4 ] and 272 age - and race-matched controls from the Cancer Prevention Study II Nutrition Cohort was conducted to determine the associations of prediagnostic plasma levels of c-peptide and adiponectin with risk of aggressive prostate cancer .
RESULTS	Neither circulating adiponectin nor c-peptide was associated with risk of aggressive prostate cancer .
RESULTS	In analyses of the highest-risk aggressive prostate cancer ( Gleason score 8 or T3-T4 ) , the highest quartile of c-peptide , compared with the lowest , was associated with an OR of 1.41 [ 95 % confidence interval ( CI ) , 0.72-2 .78 ] .
CONCLUSIONS	Our findings provide no support for the hypothesis that adiponectin is associated with risk of aggressive prostate cancer but a possible association of high levels of c-peptide with particularly high-risk prostate cancer can not be ruled out .
CONCLUSIONS	These results indicate that changes in circulating levels of adiponectin and c-peptide do not play an important role in risk of aggressive prostate cancer .

###25146063
OBJECTIVE	Recent studies have thrown doubt on the true effectiveness of anti-depressants in light and moderate depression .
OBJECTIVE	The aim of this study is to evaluate the impact of physical training and music therapy on a sample group of subjects affected by light to moderate depression versus subjects treated with pharmacological therapy only .
METHODS	Randomized controlled study .
METHODS	Patients were randomized into two groups .
METHODS	Subjects in the pharmacotherapy group received a therapy with antidepressant drugs ; the exercise/music therapy group was assigned to receive physical exercise training combined with listening to music .
METHODS	The effects of interventions were assessed by differences in changes in mood state between the two groups .
METHODS	Medically eligible patients were screened with the Hamilton Anxiety Scale and with the Geriatric Depression Scale .
METHODS	We used plasmatic cytokine dosage as a stress marker .
RESULTS	We recruited 24 subjects ( mean age : 75.5 7.4 , 11 M/13 F ) .
RESULTS	In the pharmacotherapy group there was a significant improvement in anxiety only ( p < 0.05 ) at 6-months .
RESULTS	In the exercise/music therapy was a reduction in anxiety and in depression at 3-months and at 6-months ( p < 0.05 ) .
RESULTS	We noted an average reduction of the level of TNF-a from 57.67 ( 39.37 ) pg/ml to 35.80 ( 26.18 ) pg/ml .
CONCLUSIONS	Our training may potentially play a role in the treatment of subjects with mild to moderate depression .
CONCLUSIONS	Further research should be carried out to obtain more evidence on effects of physical training and music therapy in depressed subjects .

###25919526
OBJECTIVE	Although retrievable inferior vena cava filters are frequently used in addition to anticoagulation in patients with acute venous thromboembolism , their benefit-risk ratio is unclear .
OBJECTIVE	To evaluate the efficacy and safety of retrievable vena cava filters plus anticoagulation vs anticoagulation alone for preventing pulmonary embolism recurrence in patients presenting with acute pulmonary embolism and a high risk of recurrence .
METHODS	Randomized , open-label , blinded end point trial ( PREPIC2 ) with 6-month follow-up conducted from August 2006 to January 2013 .
METHODS	Hospitalized patients with acute , symptomatic pulmonary embolism associated with lower-limb vein thrombosis and at least 1 criterion for severity were assigned to retrievable inferior vena cava filter implantation plus anticoagulation ( filter group ; n = 200 ) or anticoagulation alone with no filter implantation ( control group ; n = 199 ) .
METHODS	Initial hospitalization with ambulatory follow-up occurred in 17 French centers .
METHODS	Full-dose anticoagulation for at least 6 months in all patients .
METHODS	Insertion of a retrievable inferior vena cava filter in patients randomized to the filter group .
METHODS	Filter retrieval was planned at 3 months from placement .
METHODS	Primary efficacy outcome was symptomatic recurrent pulmonary embolism at 3 months .
METHODS	Secondary outcomes were recurrent pulmonary embolism at 6 months , symptomatic deep vein thrombosis , major bleeding , death at 3 and 6 months , and filter complications .
RESULTS	In the filter group , the filter was successfully inserted in 193 patients and was retrieved as planned in 153 of the 164 patients in whom retrieval was attempted .
RESULTS	By 3 months , recurrent pulmonary embolism had occurred in 6 patients ( 3.0 % ; all fatal ) in the filter group and in 3 patients ( 1.5 % ; 2 fatal ) in the control group ( relative risk with filter , 2.00 [ 95 % CI , 0.51-7 .89 ] ; P = .50 ) .
RESULTS	Results were similar at 6 months .
RESULTS	No difference was observed between the 2 groups regarding the other outcomes .
RESULTS	Filter thrombosis occurred in 3 patients .
CONCLUSIONS	Among hospitalized patients with severe acute pulmonary embolism , the use of a retrievable inferior vena cava filter plus anticoagulation compared with anticoagulation alone did not reduce the risk of symptomatic recurrent pulmonary embolism at 3 months .
CONCLUSIONS	These findings do not support the use of this type of filter in patients who can be treated with anticoagulation .
BACKGROUND	clinicaltrials.gov Identifier : NCT00457158 .

###26176074
OBJECTIVE	To evaluate the efficacy of a surgical no-touch isolation technique in primary hepatocellular carcinoma patients compared with traditional hepatectomy .
METHODS	Eighty hepatocellular carcinoma patients were randomly divided into traditional hepatectomy ( n = 40 ) and no-touch isolation technique groups ( n = 40 ) .
METHODS	We compared peripheral blood variations in alpha-fetoprotein mRNA , miRNA-221 , miRNA-224 , and miRNA-122 expression levels in both groups pre - and postoperatively using real-time fluorescent quantitative polymerase chain reaction .
RESULTS	The patients in the no-touch isolation technique group had better clinical curative effect .
RESULTS	In the traditional hepatectomy group , variations in alpha-fetoprotein mRNA copy number pre - and postoperatively indirectly indicated a significant increase in the number of exfoliated carcinoma cells induced by manipulating the liver , increasing the risk of postoperative recurrence and metastasis ( P < 0.05 ) .
RESULTS	Traditional hepatectomy patients showed higher increases in miRNA-221 and miRNA-224 expression than those in the no-touch isolation technique group ( P < 0.05 ) .
RESULTS	Tumor resection resulted in preoperative expression and high postoperative expression of miRNA-122 .
RESULTS	No-touch isolation technique patients showed a slight and significant increase ( P < 0.01 ) in miRNA-122 , which was positively correlated with postoperative liver function index .
RESULTS	Conclusion : The no-touch isolation technique is more effective than traditional hepa - tectomy in tumor resection for primary hepatocellular carcinoma .

###24345317
OBJECTIVE	To report the effect of nepafenac ( 0.1 % ) eye drops on intraocular pressure in eyes with cataract .
METHODS	Prospective randomized clinical trial .
METHODS	Three hundred and twenty-seven patients with bilateral cataracts in an institutional setting were included .
METHODS	All patients had a baseline intraocular pressure ( IOP ) 21 mm Hg without a history of intraocular surgery in the past 3 months .
METHODS	One eye of each individual was randomized to the treatment group , with the other eye acting as a control .
METHODS	Nepafenac ( 0.1 % ) eye drops were instilled 3 times a day in the eye that received treatment .
METHODS	Intraocular pressure ( IOP ) with Goldmann applanation tonometer ( GAT ) was measured at baseline and at 4 and 8 weeks .
METHODS	Proportion of eyes with an IOP elevation of > 4 mm Hg was the main outcome measure .
RESULTS	The mean age of the participants was 45.7 4.4 years .
RESULTS	Participants included 192 female and 135 male patients .
RESULTS	The mean IOP at baseline in the treated and control eyes was , respectively , 13.8 2.5 mm Hg and 13.4 3.0 mm Hg , which reduced to 12.0 2.0 mm Hg and 12.1 1.5 mm Hg , respectively , at the end of 8 weeks .
RESULTS	This reduction in IOP in both groups was significant ( P < .01 ) .
RESULTS	The difference between the IOP in the treated and control eyes at 8 weeks was not statistically significant ( P = .34 ) .
RESULTS	One eye in the treated group and 2 eyes in the control group had an IOP elevation of > 4 mm Hg .
CONCLUSIONS	Nepafenac eye drops do not increase the IOP .
CONCLUSIONS	They can possibly be used as an alternative to steroid medications where steroid responsiveness is a concern .

###24263075
OBJECTIVE	Partitioning exercise by 1-legged cycling is more effective than conventional training in patients with chronic obstructive pulmonary disease .
OBJECTIVE	Similarly , inhaling helium-hyperoxia can extend conventional exercise tolerance .
OBJECTIVE	This study aimed to determine whether breathing helium-hyperoxia could increase the tolerance of a high-intensity exercise session achieved by 1-legged cycling .
METHODS	Participants completed 2 high-intensity , constant power , 1-legged cycle tests to intolerance ( tlimit ) .
METHODS	In a randomized order , they inspired 40 % oxygen with the balance helium via mask and 1-way valve , 1-legged helium-hyperoxia ( 1L-HH ) , or room air with supplemental oxygen via a nasal cannula , 1-legged nitrogen-hyperoxia ( 1L-NH ) .
METHODS	We assessed quadriceps fatigue from the change in maximal voluntary contraction ( FMVC ) and transcutaneously stimulated twitch force ( Ftwitch ) .
RESULTS	Fifteen participants ( forced expiratory volume in 1 second [ SD ] = 36 [ 18 ] % predicted ; forced expiratory volume in 1 second/forced vital capacity = 34 [ 14 ] % ; peak oxygen uptake = 12.8 [ 2.9 ] mL kg min ) completed the study .
RESULTS	Self-reported `` leg fatigue '' was a reason for stopping 25 of 30 tests .
RESULTS	There was no significant difference in tlimit ( 0.2 [ -1.4 to 1.8 ] min ) between 1L-HH ( 12.2 [ 5.2 ] min ) and 1L-NH ( 12.0 [ 4.1 ] min ) , or in FMVC measured shortly after HH and NH tests ( P = .09 ) .
RESULTS	The Ftwitch was less after exercise ( P < .05 ) in both conditions , without a difference between conditions ( P = .46 ) .
CONCLUSIONS	Inspiring a helium-hyperoxia mixture does not increase the endurance of what would be a typical training session , breathing supplemental oxygen , of high-intensity 1-legged constant power exercise .
CONCLUSIONS	Leg muscle fatigue was similar after 1-legged exercise with and without breathing the helium mixture .

###25084625
BACKGROUND	Approaches to training biomedical scientists have created a talented research community .
BACKGROUND	However , they have failed to create a professional workforce that includes many racial and ethnic minorities and women in proportion to their representation in the population or in PhD training .
BACKGROUND	This is particularly true at the faculty level .
BACKGROUND	Explanations for the absence of diversity in faculty ranks can be found in social science theories that reveal processes by which individuals develop identities , experiences , and skills required to be seen as legitimate within the profession .
METHODS	Using the social science theories of Communities of Practice , Social Cognitive Career Theory , identity formation , and cultural capital , we have developed and are testing a novel coaching-based model to address some of the limitations of previous diversity approaches .
METHODS	This coaching intervention ( The Academy for Future Science Faculty ) includes annual in-person meetings of students and trained faculty Career Coaches , along with ongoing virtual coaching , group meetings and communication .
METHODS	The model is being tested as a randomized controlled trial with two cohorts of biomedical PhD students from across the U.S. , one recruited at the start of their PhDs and one nearing completion .
METHODS	Stratification into the experimental and control groups , and to coaching groups within the experimental arms , achieved equal numbers of students by race , ethnicity and gender to the extent possible .
METHODS	A fundamental design element of the Academy is to teach and make visible the social science principles which highly influence scientific advancement , as well as acknowledging the extra challenges faced by underrepresented groups working to be seen as legitimate within the scientific communities .
CONCLUSIONS	The strategy being tested is based upon a novel application of the well-established principles of deploying highly skilled coaches , selected and trained for their ability to develop talents of others .
CONCLUSIONS	This coaching model is intended to be a complement , rather than a substitute , for traditional mentoring in biomedical research training , and is being tested as such .

###25294666
OBJECTIVE	To determine if 8 weeks of periodized strength resistance training ( RT ) utilizing relatively short rest interval lengths ( RI ) in between sets ( SS ) would induce greater improvements in body composition and muscular performance , compared to the same RT program utilizing extended RI ( SL ) .
METHODS	22 male volunteers ( SS : n = 11 , 65.6 3.4 years ; SL : n = 11 , 70.3 4.9 years ) were assigned to one of two strength RT groups , following 4 weeks of periodized hypertrophic RT ( PHRT ) : strength RT with 60-s RI ( SS ) or strength RT with 4-min RI ( SL ) .
METHODS	Prior to randomization , all 22 study participants trained 3 days/week , for 4 weeks , targeting hypertrophy ; from week 4 to week 12 , SS and SL followed the same periodized strength RT program for 8 weeks , with RI the only difference in their RT prescription .
RESULTS	Following PHRT , all study participants experienced increases in lean body mass ( LBM ) ( p < 0.01 ) , upper and lower body strength ( p < 0.001 ) , and dynamic power ( p < 0.001 ) , as well as decreases in percentage body fat ( p < 0.05 ) .
RESULTS	Across the 8-week strength RT phase , SS experienced significantly greater increases in LBM ( p = 0.001 ) , flat machine bench press 1-RM ( p < 0.001 ) , bilateral leg press 1-RM ( p < 0.001 ) , narrow/neutral grip lat pulldown ( p < 0.01 ) , and Margaria stair-climbing power ( p < 0.001 ) , compared to SL .
CONCLUSIONS	This study suggests 8 weeks of periodized high-intensity strength RT with shortened RI induces significantly greater enhancements in body composition , muscular performance , and functional performance , compared to the same RT prescription with extended RI , in older men .
CONCLUSIONS	Applied professionals may optimize certain RT-induced adaptations , by incorporating shortened RI .

###25466837
BACKGROUND	Coagulopathy associates with poor outcome in sepsis .
BACKGROUND	Mild induced hypothermia has been proposed as treatment in sepsis but it is not known whether this intervention worsens functional coagulopathy .
METHODS	Interim analysis data from an ongoing randomized controlled trial ; The Cooling And Surviving Septic shock ( CASS ) study .
METHODS	Patients suffering severe sepsis/septic shock are allocated to either mild induced hypothermia ( cooling to 32-34C for 24hours ) or control ( uncontrolled temperature ) .
BACKGROUND	NCT01455116 .
BACKGROUND	Thrombelastography ( TEG ) is performed three times during the first day after study enrollment in all patients .
BACKGROUND	Reaction time ( R ) , maximum amplitude ( MA ) and patients ' characteristics are here reported .
RESULTS	One hundred patients ( control n = 50 and intervention n = 50 ; male n = 59 ; median age 68years ) with complete TEG during follow-up were included .
RESULTS	At enrollment , 3 % , 38 % , and 59 % had a hypocoagulable , normocoagulable , and hypercoagulable TEG clot strength ( MA ) , respectively .
RESULTS	In the hypothermia group , functional coagulopathy improved during the hypothermia phase , measured by R and MA , in patients with hypercoagulation as well as in patients with hypocoagulation ( correlation between R and initial R : rho = -0.60 , p < 0.0001 and correlation between MA and initial MA : rho = -0.50 , p = 0.0002 ) .
RESULTS	Similar results were not observed in the control group neither for R ( rho = -0.03 , p = 0.8247 ) nor MA ( rho = -0.15 , p = 0.3115 ) .
CONCLUSIONS	Mild induced hypothermia did seem to improve functional coagulopathy in septic patients .
CONCLUSIONS	This improvement of functional coagulopathy parameters during the hypothermia intervention persisted after rewarming .
CONCLUSIONS	Randomized trials are warranted to determine whether the positive effect on sepsis-related coagulopathy can be transformed to improved survival .

###24604360
OBJECTIVE	To assess the efficacy of anti-xerostomic topical medication ( urea 10 % ) in patients with burning mouth syndrome ( BMS ) .
METHODS	Thirty-eight subjects diagnosed with BMS according to the International Association for the Study of Pain guidelines were randomized to either placebo ( 5 % sodium carboxymethylcellulose , 0.15 % methyl paraben , and 10 % glycerol in distilled water qsp 100 g ) or treatment ( urea 10 % ) to be applied to the oral cavity 3-4 times per day for 3 months .
METHODS	The patients were evaluated before and after treatment with the following instruments : the EDOF-HC protocol ( Orofacial Pain Clinic - Hospital das Clnicas ) , a xerostomia questionnaire , and quantitative sensory testing .
RESULTS	There were no differences in salivary flow or gustative , olfactory , or sensory thresholds ( P > 0.05 ) .
RESULTS	Fifteen ( 60 % ) patients reported improvement with the treatments ( P = 0.336 ) .
CONCLUSIONS	In conclusion , there were no differences between groups , and both exhibited an association between reported improvement and salivation .

###24376248
OBJECTIVE	To determine the level of agreement and potential impact on disease-modifying antirheumatic drug ( DMARD ) escalation decisions and of adding musculoskeletal ultrasound ( MSUS ) assessment of disease activity to the Disease Activity Score in 28 joints ( DAS28 ) in early rheumatoid arthritis ( RA ) .
METHODS	Data were gathered from 53 early RA patients randomized to the MSUS assessment group of the Targeting Synovitis in Early Rheumatoid Arthritis study .
METHODS	DAS28 scores were calculated every month .
METHODS	MSUS was performed on patients with low disease activity ( DAS28 < 3.2 ) and on those with moderate disease activity ( 3.2 DAS28 < 5.1 ) without clinically swollen joints ( swollen joint count [ SJC ] 1 ) .
METHODS	Fourteen joints ( bilateral proximal interphalangeal joints 2 and 3 , metacarpophalangeal [ MCP ] joints 2 and 3 , the radiocarpal , and metatarsophalangeal joints 2 and 5 ) were examined .
METHODS	Active disease was defined as 2 joints demonstrating any power Doppler ( PD ) signal .
METHODS	Data from 414 paired DAS28 and MSUS assessments were pooled to determine the level of agreement between each method .
RESULTS	A total of 369 MSUS assessments were conducted on patients with DAS28 < 3.2 ; 92 ( 25 % ) of these assessments identified active disease .
RESULTS	A total of 271 MSUS assessments were performed on those with DAS28 < 2.6 ; 66 ( 24 % ) of these identified active disease .
RESULTS	Forty-five MSUS assessments were conducted on patients with 3.2 DAS28 < 5.1 and SJC 1 ; 15 ( 33 % ) of these assessments confirmed active disease .
RESULTS	On 120 occasions ( 29 % ) , MSUS findings contradicted the DAS28 and led to modified treatment decisions .
RESULTS	The joints that most frequently exhibited PD signal were radiocarpal and index and middle MCP joints .
CONCLUSIONS	Compared to the DAS28 , global RA disease activity assessment using a limited MSUS joint set provided additional disease activity information and led to altered treatment decisions in a significant minority of occasions .
CONCLUSIONS	This may allow further tailoring of DMARD therapy by supporting DMARD escalation in patients with continuing subclinical synovitis and preventing escalation in symptomatic patients with minimal clinical and/or ultrasonographic synovitis .

###25300225
BACKGROUND	Breast density is an established predictor of breast cancer risk , and there is considerable interest in associations of modifiable lifestyle factors , such as diet , with breast density .
OBJECTIVE	To determine whether dietary energy density ( ED ) is associated with percent dense breast volume ( % DBV ) and absolute dense breast volume ( ADBV ) in young women .
METHODS	A cross-sectional analysis was conducted with women who participated in the Dietary Intervention Study in Children Follow-Up Study .
METHODS	% DBV and ADBV were measured by magnetic resonance imaging .
METHODS	Diet was assessed by three 24-hour recalls .
METHODS	Dietary ED ( kilocalories/gram ) was calculated using three methods : food only , food and caloric beverages , and food and all beverages .
METHODS	One hundred seventy-two women ( aged 25 to 29 years ) who were enrolled in the Dietary Intervention Study in Children Follow-Up Study .
METHODS	Participants who reported breast augmentation or reduction surgery or were pregnant or lactating within 3 months before breast density assessment were excluded .
METHODS	ADBV and % DBV .
METHODS	Multivariable linear mixed effects models were used .
METHODS	Final models were adjusted for race , smoking status , education , parity , duration of sex hormone use , whole body percent fat , childhood body mass index z score , and energy from beverages .
RESULTS	After adjustment , each 1 kcal/g unit increase in food-only ED was associated with a 25.9 % ( 95 % CI 6.2 % to 56.8 % ) increase in % DBV ( P = 0.01 ) .
RESULTS	Childhood body mass index z score modified the association between food-only ED and % DBV such that a significant positive association was observed only in women who were heavier as children .
RESULTS	Food-only ED was not associated with ADBV in all women , but a borderline significant positive association was observed in women who had higher childhood body mass index z scores .
CONCLUSIONS	This is the first report to suggest a potential role for dietary ED in breast density ; the effects of long-term exposure to high-ED diets on breast cancer risk remain unknown .

###25353642
OBJECTIVE	To our knowledge , there is no level 1 evidence comparing open bypass with angioplasty and stenting in TransAtlantic Inter-Society Consensus ( TASC II ) B and C superficial femoral artery lesions .
OBJECTIVE	The Revascularization With Open Bypass vs Angioplasty and Stenting of the Lower Extremity Trial ( ROBUST ) is the first prospective randomized clinical trial comparing both treatments .
OBJECTIVE	To report the design of the ROBUST trial .
OBJECTIVE	The primary aim of the trial is to compare ( 1 ) the patency rate ( primary , primary assisted , and secondary patency at 6 and 12 months ) , ( 2 ) improvement of quality of life , ( 3 ) clinical improvement ( at least 1 Rutherford category ) , and ( 4 ) wound healing and limb salvage in patients presenting with critical limb ischemia ; secondary aims include ( 1 ) cost-effectiveness by factoring procedure and hospital admission costs including rehabilitation , readmission , and reintervention costs , ( 2 ) amputation-free survival , ( 3 ) reintervention rate , and ( 4 ) 30-day operative mortality , morbidity , and wound and access complications .
METHODS	ROBUST is a prospective randomized clinical trial with the aim to enroll 320 patients with intermittent claudication that does not respond to medical management and patients with critical limb ischemia .
METHODS	The maximum level of medical therapy will be administered using antiplatelet agents and statins , as well as measures to control hypertension and diabetes mellitus .
METHODS	Patients with TASC II B or C lesions are prospectively randomized to receive either femoropopliteal bypass or percutaneous transluminal angioplasty and stenting ; patients with TASC II A and D lesions are not randomized and receive percutaneous transluminal angioplasty and stenting or femoropopliteal bypass , respectively .
METHODS	All patients will be evaluated at 1 , 6 , and 12 months postoperatively with physical examination , ankle brachial index , duplex , and a quality-of-life questionnaire .
RESULTS	The trial is actively enrolling participants .
RESULTS	At the time of writing , 29 patients have been enrolled ; most are male ( 60 % ) and white ( 65 % ) .
CONCLUSIONS	Providing level 1 evidence , ROBUST may help to establish guidelines for the treatment of superficial femoral artery lesions , eliminate unnecessary procedures , and reduce health care costs .
BACKGROUND	clinicaltrials.gov Identifier : NCT01602159 .

###24242902
OBJECTIVE	We evaluated the safety , tolerability , and pharmacokinetics ( PK ) of EMD 525797 ( DI17E6 ) , a humanized monoclonal antibody targeting v-integrins , in healthy subjects .
METHODS	In this first-in-human , double-blind , placebo-controlled , randomized Phase 1 study , healthy male volunteers were consecutively assigned to 6 ascending single-dose cohorts of 35 , 100 , 250 , 500 , 1000 , or 1500 mg .
METHODS	Per dose cohort , EMD 525797 or placebo was administered over 1 h as an intravenous 250-mL infusion to 6 and 3 volunteers , respectively .
METHODS	Escalation to the next dose level was based on evaluation of safety , tolerability , and PK data .
RESULTS	Fifty-five subjects ( aged 18-45 years ) were randomized .
RESULTS	Twenty-seven of 37 ( 73 % ) subjects receiving EMD 525797 reported a total of 61 adverse events ( AEs ) , including 38 events ( in 17 subjects ) considered by the investigator to be treatment related .
RESULTS	A total of 35 AEs were reported by 14 of 18 ( 78 % ) placebo-treated subjects .
RESULTS	The most commonly occurring AEs were gastrointestinal disorders , abnormal laboratory values , and increased or decreased biochemistry and/or hematology values , as well as headaches , which occurred at a slightly higher frequency in the EMD 525797 group compared with placebo .
RESULTS	There were no serious AEs or deaths .
RESULTS	EMD 525797 PK appeared to be dose dependent , especially at lower doses .
CONCLUSIONS	Ascending single doses of EMD 525797 were shown to be safe and well tolerated .
CONCLUSIONS	No safety concerns were identified .
CONCLUSIONS	This study supports the ongoing investigation of EMD 525797 .

###25139487
OBJECTIVE	Erythromycin is a macrolide antibiotic , which is frequently used as a topical formulation for the treatment of acne .
OBJECTIVE	It is also known as an inhibitor of the cytochrome P450 ( CYP ) isoenzyme 3A4 .
OBJECTIVE	In this study , the systemic availability of topical erythromycin , hence the influence on the activity of CYP3A , is evaluated in comparison to orally administered erythromycin .
METHODS	Sixteen healthy volunteers received consecutively topical ( two applications of 800mg ) and oral erythromycin ( two dose groups , 250 and 1000mg , with n = 8 ) to assess erythromycin pharmacokinetics .
METHODS	A microdose of midazolam ( 3g orally ) was used to determine the effect on CYP3A activity .
RESULTS	After topical administration , erythromycin was detected in the plasma of every participant without causing a statistically significant alteration of CYP3A activity .
RESULTS	After oral administration , the dose-normalized erythromycin exposure ( AUC ) was 1335hngml ( -1 ) after 250mg and 3-fold higher after the 1000mg dose ( 4051hngml ( -1 ) ; P < 0.01 ) , suggesting nonlinear pharmacokinetics of erythromycin .
RESULTS	Both oral doses inhibited CYP3A activity ; midazolam clearance was decreased to 61 % ( 250mg ) and 21 % ( 1000mg ) .
RESULTS	The relationship between erythromycin exposure and CYP3A activity ( Hill equation ) revealed a 50 % reduction of CYP3A activity by an erythromycin AUC of 2106hngml ( -1 ) .
CONCLUSIONS	Topical erythromycin did not cause clinically relevant CYP3A alterations , although low systemic availability of erythromycin was observed .
CONCLUSIONS	This supports the assumption that treatment with topical erythromycin is not critical in terms of CYP3A inhibition .
CONCLUSIONS	Furthermore , substantial nonlinearity of erythromycin pharmacokinetics after two different oral doses was observed , possibly due to autoinhibition .

###25526870
BACKGROUND	Socially disadvantaged men are at a substantially higher risk of developing alcohol-related problems .
BACKGROUND	The frequency of heavy drinking in a single session is high among disadvantaged men .
BACKGROUND	Brief alcohol interventions were developed for , and are usually delivered in , healthcare settings .
BACKGROUND	The group who binge drink most frequently , young to middle-aged disadvantaged men , have less contact with health services and there is a need for an alternative method of intervention delivery .
BACKGROUND	Text messaging has been used successfully to modify other adverse health behaviours .
BACKGROUND	This study will test whether text messages can reduce the frequency of binge drinking by disadvantaged men .
METHODS	Disadvantaged men aged 25 to 44years who drank > 8 units of alcohol at least twice in the preceding month will be recruited from the community .
METHODS	Two recruitment strategies will be used : contacting men listed in primary care registers , and a community outreach method ( time-space sampling ) .
METHODS	The intended sample of 798 men will be randomised to intervention or control , stratifying by recruitment method .
METHODS	The intervention group will receive a series of text messages designed to reduce the frequency of binge drinking through the formation of specific action plans .
METHODS	The control group will receive behaviourally neutral text messages intended to promote retention in the study .
METHODS	The primary outcome measure is the proportion of men consuming > 8 units on at least three occasions in the previous 30days .
METHODS	Secondary outcomes include total alcohol consumption and the frequency of consuming more than 16 units of alcohol in one session in the previous month .
METHODS	Process measures , developed during a previous feasibility study , will monitor engagement with the key behaviour change components of the intervention .
METHODS	The study will incorporate an economic evaluation comparing the costs of recruitment and intervention delivery with the benefits of reduced alcohol-related harm .
CONCLUSIONS	This study will assess the effectiveness of a brief intervention , delivered by text messages , aimed at reducing the frequency of binge drinking in disadvantaged men .
CONCLUSIONS	The process measures will identify components of the intervention which contribute to effectiveness .
CONCLUSIONS	The study will also determine whether any benefit of the intervention is justified by the costs of intervening .
BACKGROUND	ISRCTN07695192 .
BACKGROUND	Date assigned : 14 August 2013 .

###26217423
BACKGROUND	Pediatricians underestimate the prevalence of substance misuse among children and adolescents and often fail to screen for and intervene in practice .
BACKGROUND	The American Academy of Pediatrics recommends training in Screening , Brief Intervention , and Referral to Treatment ( SBIRT ) , but training outcomes and skill acquisition are rarely assessed .
OBJECTIVE	We compared the effects of online versus in-person SBIRT training on pediatrics residents ' knowledge , attitudes , behaviors , and skills .
METHODS	Forty pediatrics residents were randomized to receive either online or in-person training .
METHODS	Skills were assessed by pre - and posttraining standardized patient interviews that were coded for SBIRT-adherent and - nonadherent behaviors and global skills by 2 trained coders .
METHODS	Thirty-two residents also completed pre - and postsurveys of their substance use knowledge , attitudes , and behaviors ( KABs ) .
METHODS	Two-way repeated measures multivariate analyses of variance ( MANOVAs ) and analyses of variance ( ANOVAs ) estimates were used to assess group differences in skill acquisition and KABs .
RESULTS	Findings indicated that both groups demonstrated skill improvement from pre - to postassessment .
RESULTS	Results indicated that both groups increased their knowledge , self-reported behaviors , confidence , and readiness with no significant between-group differences .
RESULTS	Follow-up univariate analyses indicated that , while both groups increased their SBIRT-adherent skills , the online training group displayed more `` undesirable '' behaviors posttraining .
CONCLUSIONS	The current study indicates that brief training , online or in-person , can increase pediatrics residents ' SBIRT skills , knowledge , self-reported behaviors , confidence , and readiness .
CONCLUSIONS	The findings further indicate that in-person training may have incremental benefit in teaching residents what not to do .

###24801219
OBJECTIVE	To investigate effects and functional mechanism of compound Congrongyizhi Capsule ( CCRC ) , a Chinese medicine , on cognitive functions against amnestic mild cognitive impairment ( aMCI ) patients with functional magnetic resonance imaging ( fMRI ) based on n-back task .
METHODS	Forty-one aMCI participants from hospital and local communities in Beijing and randomly divided into treatment ( 16 patients with CCRC capsule treatment ) , placebo ( 12 patients with placebo capsules ) and control group ( 13 patients with no treatment ) .
METHODS	The duration of intervention lasted for 3 months .
METHODS	Neuropsychological tests and fMRI were applied to assess cognitive ability and brain activation changes after three months treatment .
RESULTS	Drug group ( n = 16 ) presented increased significance in the MMSE ( P = 0.008 ) and digit span ( P < 0.001 ) tests , while other scores of neuropsychological tests showed no statistical significance .
RESULTS	fMRI results showed an increased brain negative activation in drug group during performing the n-back working-memory task in posterior cingulate ( PCC ) , inferior frontal gyrus and lingual gyrus regions after 3 months ; placebo and control group did not show the same effect .
RESULTS	Meanwhile , there were negative correlations between left PCC activation levels and changed values of MMSE and digit span separately since increased negative activation was associated with better performance on the scores of MMSE and Digit Span tests .
CONCLUSIONS	CCRC can increase negative activation degree of PCC under performing working memory tasks while this modulation are associated with better performance on the MMSE and Digit Span .

###25027459
BACKGROUND	187,000 hip and knee joint replacements are performed every year in the National Health Service ( NHS ) .
BACKGROUND	One of the commonest complications is surgical site infection ( SSI ) , and this represents a significant burden in terms of patient morbidity , mortality and cost to health services around the world .
BACKGROUND	The aim of this randomised controlled trial ( RCT ) is to determine if the addition of triclosan coated sutures to a standard regimen can reduce the rate of SSI after total knee replacement ( TKR ) and total hip replacement ( THR ) .
METHODS	2400 patients due to undergo a total hip or knee replacement are being recruited into this two-centre RCT .
METHODS	Participants are recruited before surgery and randomised to either standard care or intervention group .
METHODS	Participants , outcome assessors and statistician are blind to treatment allocation throughout the study .
METHODS	The intervention consists of triclosan coated sutures vs. standard non-coated sutures .
METHODS	The primary outcome is the Health protection Agency ( HPA ) defined superficial surgical site infection at 30 days .
METHODS	Secondary outcomes include HPA defined deep surgical site infection at 12 months , length of hospital stay , critical care stay , and payer costs .
CONCLUSIONS	To date there are no orthopaedic randomised controlled trials on this scale assessing the effectiveness of a surgical intervention , particularly those that can be translated across the surgical specialities .
CONCLUSIONS	The results from this trial will inform evidence-based recommendations for suture selection in the management of patients undergoing total hip or knee replacement .
CONCLUSIONS	If triclosan coated sutures are found to be an effective intervention , implementation into clinical practice could improve long-term outcomes for patients undergoing hip and knee replacement .
BACKGROUND	Current Controlled Trials ISRCTN 17807356 .

###25152325
BACKGROUND	Immunogenicity and safety of a single dose of MenACWY-TT or a fourth dose of HibMenCY-TT were evaluated in the second year of life in HibMenCY-TT-primed toddlers .
METHODS	Healthy infants were randomized ( 5:1 ) and primed at 2 , 4 and 6 months of age with HibMenCY-TT and diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus ( DTaP-HBV-IPV ) vaccine ; or Hib-TT and DTaP-HBV-IPV ( control ) .
METHODS	Recipients of HibMenCY-TT + DTaP-HBV-IPV were re-randomized ( 2:2:1 ) to receive MenACWY-TT at 12-15 months and DTaP at 15-18 months ; MenACWY-TT co-administered with DTaP at 15-18 months ; or HibMenCY-TT at 12-15 months and DTaP at 15-18 months .
METHODS	Controls received DTaP only at 15-18 months due to Hib conjugate vaccine shortage .
METHODS	Serum bactericidal activity using human complement ( hSBA ) and safety were assessed one month after meningococcal vaccination .
RESULTS	After vaccination with MenACWY-TT at 12-15 months or MenACWY-TT + DTaP at 15-18 months , all subjects previously primed for serogroups C/Y had hSBA 1:8 for these serogroups .
RESULTS	At least 96.1 % also had hSBA 1:8 for serogroups A/W .
RESULTS	All subjects in the HibMenCY-TT group had hSBA 1:8 for serogroups C/Y .
RESULTS	All pre-defined statistical criteria for meningococcal immunogenicity were satisfied .
RESULTS	All vaccination regimens had acceptable safety profiles .
CONCLUSIONS	Children primed with three doses of HibMenCY-TT who then received a single dose of MenACWY-TT or a fourth dose of HibMenCY-TT had robust increases in hSBA titers for serogroups C/Y .
CONCLUSIONS	These data provide support that MenACWY-TT , given with or without the fourth scheduled dose of DTaP could be administered as an alternative to a fourth dose of HibMenCY-TT in the second year of life .
CONCLUSIONS	This study ( 110870/110871 ) is registered at www.clinicaltrials.gov NCT00614614 .

###25468170
BACKGROUND	Duration of treatment for patients with vertebral osteomyelitis is mainly based on expert recommendation rather than evidence .
BACKGROUND	We aimed to establish whether 6 weeks of antibiotic treatment is non-inferior to 12 weeks in patients with pyogenic vertebral osteomyelitis .
METHODS	In this open-label , non-inferiority , randomised controlled trial , we enrolled patients aged 18 years or older with microbiologically confirmed pyogenic vertebral osteomyelitis and typical radiological features from 71 medical care centres across France .
METHODS	Patients were randomly assigned to either 6 weeks or 12 weeks of antibiotic treatment ( physician 's choice in accordance with French guidelines ) by a computer-generated randomisation list of permuted blocks , stratified by centre .
METHODS	The primary endpoint was the proportion of patients who were classified as cured at 1 year by a masked independent validation committee , analysed by intention to treat .
METHODS	Non-inferiority would be declared if the proportion of cured patients assigned to 6 weeks of treatment was not less than the proportion of cured patients assigned to 12 weeks of treatment , within statistical variability , by an absolute margin of 10 % .
METHODS	This trial is registered with EudraCT , number 2006-000951-18 , and Clinical Trials.gov , number NCT00764114 .
RESULTS	Between Nov 15 , 2006 , and March 15 , 2011 , 359 patients were randomly assigned , of whom six in the 6-week group and two in the 12-week group were excluded after randomisation .
RESULTS	176 patients assigned to the 6-week treatment regimen and 175 to the 12-week treatment regimen were analysed by intention to treat .
RESULTS	160 ( 909 % ) of 176 patients in the 6-week group and 159 ( 909 % ) of 175 of those in the 12-week group met the criteria for clinical cure .
RESULTS	The difference between the groups ( 005 % , 95 % CI -62 to 63 ) showed the non-inferiority of the 6-week regimen when compared with the 12-week regimen .
RESULTS	50 patients in the 6-week group and 51 in the 12-week group had adverse events , the most common being death ( 14 [ 8 % ] in the 6-week group vs 12 [ 7 % ] in the 12-week group ) , antibiotic intolerance ( 12 [ 7 % ] vs 9 [ 5 % ] ) , cardiorespiratory failure ( 7 [ 4 % ] vs 12 [ 7 % ] ) , and neurological complications ( 7 [ 4 % ] vs 3 [ 2 % ] ) .
CONCLUSIONS	6 weeks of antibiotic treatment is not inferior to 12 weeks of antibiotic treatment with respect to the proportion of patients with pyogenic vertebral osteomyelitis cured at 1 year , which suggests that the standard antibiotic treatment duration for patients with this disease could be reduced to 6 weeks .
BACKGROUND	French Ministry of Health .

###25375979
BACKGROUND	TNF - generates inflammatory responses and insulin resistance , lipolysis , and protein breakdown .
BACKGROUND	It is unclear whether these changes depend on intact hypothalamo-pituitary stress hormone responses to trigger the release of cortisol and growth hormone .
OBJECTIVE	To define differential effects of TNF - on glucose , protein , and lipid metabolism in hypopituitary patients ( without intact hypothalamo-pituitary axis ) and healthy controls .
METHODS	Randomized , placebo controlled , single-blinded .
METHODS	Setting , Participants , and Intervention : We studied eight hypopituitary ( HP ) patients and eight matched control subjects [ control volunteers ( CTR ) ] twice during 4-h basal and 2-h hyperinsulinemic clamp conditions with isotope dilution during infusion of saline or TNF - ( 12 ng/kg/h ) for 6 h.
METHODS	Phenylalanine , urea , palmitate , and glucose fluxes and fat biopsies in basal and clamp periods .
RESULTS	TNF - infusion significantly increased cortisol and GH levels in CTR but not in HP .
RESULTS	TNF - increased phenylalanine fluxes in both groups , with the increase being significantly greater in CTR , and raised urea flux by 40 % in CTR without any alteration in HP .
RESULTS	Endogenous glucose production ( EGP ) was elevated in CTR compared to HP after TNF - administration , whereas insulin sensitivity remained similarly unaffected in both groups .
RESULTS	TNF - increased whole body palmitate fluxes and decreased palmitate specific activity in CTR , but not in HP without statistical difference between groups .
RESULTS	We did not detect significant effects TNF - on lipase expression or regulation in fat .
CONCLUSIONS	TNF - increased both urea and amino acid fluxes and EGP significantly more in CTR compared to HP , suggesting that increases in endogenous cortisol and GH release are significant components of the metabolic response to TNF - .

###25042995
BACKGROUND	The root bark of Aralia is a rich source of bioactive components that may improve glycemic control and lipid status .
BACKGROUND	In this study , 148 patients with type 2 diabetes mellitus ( T2DM ) were assigned randomly to receive either glipizide alone or glipizide plus Aralia root bark extract ( ARBE ) for 8 weeks to test the effects of ARBE plus glipizide therapy on glycemic control and lipid profiles in these patients .
RESULTS	Levels of HbA1c , fasting plasma glucose ( FPG ) and 2 h postprandial plasma glucose ( 2-h PPG ) in both groups significantly decreased from baseline .
RESULTS	Glycated hemoglobin ( HbA1c ) decreased marginally significantly in participants taking glipizide plus ARBE compared with the glipizide group ( P = 0.06 ) .
RESULTS	Participants in the combination group had significant decreases in total cholesterol ( TC ) and low-density lipoprotein cholesterol ( LDL-C ) , and the between-group difference achieved statistical significance for LDL-C ( P = 0.04 ) .
RESULTS	Reduction in HbA1c in the combination group was significantly associated with changes in TC ( r = 0.32 ; P = 0.006 ) and LDL-C ( r = 0.34 ; P = 0.005 ) , and the change in FPG was inversely correlated with LDL-C reduction ( r = 0.34 ; P = 0.004 ) .
CONCLUSIONS	In patients with T2DM , combination therapy with glipizide and ARBE resulted in moderately lowering HbA1c and LDL-C levels compared with glipizide alone .

###24592906
OBJECTIVE	To evaluate the velocity of canine retraction , anchorage loss and changes on canine and first molar inclinations using self-ligating and conventional brackets .
METHODS	Twenty-five adults with Class I malocclusion and a treatment plan involving extractions of four first premolars were selected for this randomized split-mouth control trial .
METHODS	Patients had either conventional or self-ligating brackets bonded to maxillary canines randomly .
METHODS	Retraction was accomplished using 100-g nickel-titanium closed coil springs , which were reactivated every 4 weeks .
METHODS	Oblique radiographs were taken before and after canine retraction was completed , and the cephalograms were superimposed on stable structures of the maxilla .
METHODS	Cephalometric points were digitized twice by a blinded operator for error control , and the following landmarks were collected : canine cusp and apex horizontal changes , molar cusp and apex horizontal changes , and angulation changes in canines and molars .
METHODS	The blinded data , which were normally distributed , were analyzed through paired t-tests for group differences .
RESULTS	No differences were found between the two groups for all variables tested .
CONCLUSIONS	Both brackets showed the same velocity of canine retraction and loss of anteroposterior anchorage of the molars .
CONCLUSIONS	No changes were found between brackets regarding the inclination of canines and first molars .

###24680768
BACKGROUND	Tacrolimus is an established immunosuppressant used for the prevention and treatment of allograft rejection in solid organ transplantation .
BACKGROUND	An immediate-release oral formulation of tacrolimus has been commercially available since 1994 that is administered orally BID .
BACKGROUND	To improve the compliance and quality of life of transplant patients , a once-daily modified release ( MR ) formulation is an attractive option .
BACKGROUND	However , to be successful , the drug of interest must be sufficiently well absorbed from the distal region of the gastrointestinal tract .
OBJECTIVE	To facilitate the development of an MR formulation , we investigated the absorption of tacrolimus from different regions of the human gastrointestinal tract , proximal and distal small bowels , and ascending colon .
METHODS	The study was performed as an open-label , randomized , 4-way crossover design in 6 healthy white male subjects .
METHODS	For each subject , 1 mg ( 2 mg/mL ) of tacrolimus solution in polyethylene glycol 400 was administered to each location in the gastrointestinal tract via a site-specific radiolabeled delivery capsule , which can release tacrolimus solution at specific sites of the gastrointestinal tract .
METHODS	Real-time visualization of capsule location and tacrolimus release at each target site was performed by using - scintigraphy .
METHODS	Blood samples were collected to determine tacrolimus levels in the blood .
METHODS	The pharmacokinetic parameters Cmax , Tmax after the capsule activation , AUC0-24 , and mean residence time were determined from the concentration-time profiles .
RESULTS	Ten healthy male subjects underwent dosing .
RESULTS	Six subjects completed all 4 treatments .
RESULTS	Three adverse events ( mild headache [ n = 1 ] , small amount of blood in stool [ n = 1 ] , and mild syncopal episode [ n = 1 ] ) that were possibly study drug related were reported in 3 different subjects .
RESULTS	Tacrolimus was absorbed from not only the small intestine but also from the colonic region of the gastrointestinal tract .
RESULTS	Although AUC0-24 values revealed some site-specific absorption tendencies , the mean AUC0-24 values obtained were similar regardless of the location of tacrolimus release from the capsule .
CONCLUSIONS	Tacrolimus was absorbed from the duodenum to the colon in these male subjects , although differences were observed in the value of AUC0-24 , possibly due to variation in cytochrome P450 3A4 activity in the intestine .
CONCLUSIONS	Although this study was conducted in small group of healthy fasting men , the present results indicate that tacrolimus is suitable for MR formulation development due to a wide absorption window throughout the intestine in humans .

###25403470
BACKGROUND	Roughly one third of disability pensions in Norway are issued for mental and behavioral disorders , and vocational rehabilitation offered to this group has traditionally been dominated by train-and-place approaches with assisted or sheltered employment .
BACKGROUND	Based on a more innovative place-and-train approach , Individual Placement and Support ( IPS ) involves supported employment in real-life competitive work settings , and has shown great promise for patients with severe mental illness .
METHODS	The study is a multicenter Randomized Controlled Trial ( RCT ) of IPS in a Norwegian context , involving an effect evaluation , a process evaluation , and a cost/benefit analysis .
METHODS	IPS will be compared to high quality treatment as usual ( TAU ) , with labor market participation and educational activity at 12 months post inclusion as the primary outcome .
METHODS	The primary outcome will be measured using register data , and the project will also include complete follow-up up to 4 years after inclusion for long-term outcome data .
METHODS	Secondary outcomes include mental health status , disability and quality of life , collected through survey questionnaires at baseline , and after 6 and 12 months .
METHODS	Participants will include patients undergoing treatment for moderate to severe mental illness who are either unemployed or on sickness or social benefits .
METHODS	The estimated total sample size of 400-500 will be randomly assigned to the interventions .
METHODS	To be eligible , participants must have an expressed desire to work , and sufficient Norwegian reading and writing skills to fill out the questionnaires .
CONCLUSIONS	The Effect Evaluation of Individual Placement and Support ( IPS ) will be one of the largest randomized controlled trials to date investigating the effectiveness of IPS on competitive employment , and the first study to evaluate the effectiveness of IPS for patients with moderate to severe mental illness within a Norwegian context .
BACKGROUND	Clinicaltrials.gov : NCT01964092 .
BACKGROUND	Registered October 16th , 2013 .

###24865255
BACKGROUND	Induction immunosuppression with anti-thymocyte globulin ( ATG ) provides potential benefits after liver transplantation ( LT ) .
BACKGROUND	However , its use in patients with LT and hepatitis C ( HCV ) is controversial .
OBJECTIVE	To evaluate the 1 - and 2-year patient survival and HCV recurrence rate in patients receiving ATG during the induction phase of immunosuppression ( IPI ) after LT.
METHODS	A total of 49 patients undergoing their first LT for HCV were randomized to receive ATG during IPI .
METHODS	Patient survival and HCV recurrence were determined at 1 and 2years .
METHODS	The frequency of acute cellular rejection ( ACR ) , infections , and neoplasms was also evaluated .
RESULTS	Twenty-six patients were randomized to receive ATG ( Arm-1 ) and 23 to standard induction therapy ( Arm-2 ) .
RESULTS	Those given ATG had lower HCV recurrence ( 26.9 vs 73.9 % , p = 0.001 ) .
RESULTS	The 1 - and 2-year patient survival rates were similar for both arms ( p = 0.33 ) .
RESULTS	Infections occurred in 46.1 % subjects in Arm-1 and 34.7 % in Arm-2 ( p = 0.562 ) .
RESULTS	There was a greater proportion of fungal infections in Arm-1 ( 19.2 vs 0 % , p = 0.032 ) .
CONCLUSIONS	ATG during the IPI was associated with lower frequency of recurrence of HCV in patients undergoing LT. This , however , did not affect the 1 - and 2-year survival and the frequency of ACR , infections , or neoplasms .

###25828037
OBJECTIVE	To compare the safety and effectiveness of small particle hyaluronic acid plus lidocaine ( SPHAL ) versus no treatment for lip augmentation and perioral rhytides .
METHODS	Adults scoring 1 ( very thin ) to 2 ( thin ) on the Medicis Lip Fullness Scale ( MLFS ) for upper and lower lips were randomized ( 3:1 ) to SPHAL or no treatment .
METHODS	Treatment success was an MLFS increase 1 point at Week 8 .
METHODS	Secondary end points ( MLFS score , independent photographic review , Global Aesthetic Improvement Scale , Wrinkle Assessment Scale for Upper Lip Lines ) and safety were assessed throughout .
RESULTS	Statistically significantly more patients were treatment successes with SPHAL ( upper lip [ 80.2 % vs 11.9 % ] , lower lip [ 84.2 % vs 18.4 % ] , and upper and lower lips combined [ 76.1 % vs 11.6 % ] ) , compared with no treatment ( p < .001 , all outcomes ) .
RESULTS	Patients treated for both lip augmentation and perioral rhytides were rated as having an aesthetically meaningful improvement in perioral rhytides ( p < .001 ) .
RESULTS	Most common treatment-emergent adverse events ( AEs ) included lip bruising , swelling , and pain and were mostly mild and transient in nature , without anticipated device AEs .
CONCLUSIONS	Small particle hyaluronic acid plus lidocaine was effective and well tolerated and significantly more effective when both lips and perioral rhytides were treated , with improvement evident up to 6 months after treatment .

###24516190
BACKGROUND	ABT-288 is a highly potent histamine-3 receptor antagonist that has demonstrated pro-cognitive effects in preclinical models relevant to schizophrenia .
BACKGROUND	This study evaluated the efficacy and safety of two doses of ABT-288 in the treatment of cognitive impairment associated with schizophrenia .
METHODS	A randomized , double-blind , placebo-controlled , parallel-group 12-week study was conducted at 23 centers in the United States .
METHODS	Clinically stable subjects with schizophrenia were randomized in an equal ratio to ABT-288 10 mg , ABT-288 25 mg , or placebo once daily while continuing their antipsychotic regimen .
METHODS	The primary efficacy measure was the change from baseline to day 84 evaluation on the Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery ( MCCB ) composite score vs placebo .
METHODS	Secondary measures included cognitive functioning and psychiatric scales .
METHODS	Safety assessments and sparse pharmacokinetic sampling were also conducted .
RESULTS	A total of 214 subjects were randomized .
RESULTS	The mean baseline MCCB composite score was 28.4 .
RESULTS	Approximately 80 % of subjects completed the study .
RESULTS	The MCCB composite score mean change from baseline to day 84 was numerically worse for both the 10 mg ( 1.90 , P = .618 ) and 25 mg ( 0.64 , P = .946 ) doses of ABT-288 vs placebo ( 2.19 ) .
RESULTS	Results from the secondary measures were consistent with the primary analysis .
RESULTS	Subjects ' schizophrenia symptoms remained stable throughout the study as evidenced by stable Positive and Negative Syndrome Scale scores .
RESULTS	Overall , study medication was tolerated ; however , an increased incidence of psychosis-related and sleep-related adverse events was associated with ABT-288 .
CONCLUSIONS	Neither dose of ABT-288 resulted in cognitive improvement in clinically stable adults with schizophrenia .

###25456365
BACKGROUND	Aromatase inhibitors prevent breast cancer in postmenopausal women at high risk of the disease but are associated with accelerated bone loss .
BACKGROUND	We assessed effectiveness of oral risedronate for prevention of reduction in bone mineral density ( BMD ) after 3 years of follow-up in a subset of patients in the IBIS-II trial .
METHODS	The double-blind IBIS-II trial recruited 3864 healthy , postmenopausal women at increased risk of breast cancer and randomly allocated them oral anastrozole ( 1 mg/day ) or matched placebo .
METHODS	1410 ( 36 % ) postmenopausal women were then enrolled in a bone substudy and stratified at baseline according to their lowest baseline T score at spine or femoral neck ( stratum I : T score at least -10 ; stratum II : T score at least -25 but less than -10 ; stratum III : T score less than -25 but greater than -40 ) .
METHODS	Women in stratum I were monitored only ; women in stratum III were all given risedronate ( 35 mg/week ) .
METHODS	Women in stratum II were randomly assigned ( 1:1 ) to risedronate ( 35 mg/week ) or matched placebo by use of a block randomisation schedule via a web-based programme .
METHODS	The primary outcome of this per-protocol analysis ( done with all women with a baseline and 3 year DXA assessment ) was the effect of risedronate versus placebo for osteopenic women in stratum II randomly allocated to anastrozole ( 1 mg/day ) .
METHODS	Secondary outcomes included effect of anastrozole ( 1 mg/day ) on BMD in women not receiving risedronate ( strata I and II ) and in osteoporotic women who were all treated with risedronate ( stratum III ) .
METHODS	The trial is ongoing , but no longer recruiting .
METHODS	This trial is registered , number ISRCTN31488319 .
RESULTS	Between Feb 2 , 2003 , and Sept 30 , 2010 , 150 ( 58 % ) of 260 women in stratum II who had been randomly allocated to anastrozole and either risedronate or placebo had baseline and 3 year assessments .
RESULTS	At the lumbar spine , 3 year mean BMD change for the 77 women receiving anastrozole/risedronate was 11 % ( 95 % CI 02 to 21 ) versus -26 % ( -40 to -13 ) for the 73 women receiving anastrozole/placebo ( p < 00001 ) .
RESULTS	For the total hip , 3 year mean BMD change for women receiving anastrozole/risedronate was -07 % ( -16 to 02 ) versus -35 % ( -46 to -23 ) for women receiving anastrozole/placebo ( p = 00001 ) .
RESULTS	652 ( 65 % ) of 1008 women in strata I and II who were not randomly allocated to risedronate had both baseline and 3 year assessments .
RESULTS	Women not receiving risedronate in stratum I and II who received anastrozole ( 310 women ) had a significant BMD decrease after 3 years of follow-up compared with women who received placebo ( 342 women ) at the lumbar spine ( -40 % [ -45 to -34 ] vs -12 % [ -17 to -07 ] , p < 00001 ) and total hip ( -40 % [ -44 to -36 ] vs -18 % [ -21 to -14 ] , p < 00001 ) .
RESULTS	106 ( 79 % ) of 149 women in stratum III had a baseline and a 3 year assessment .
RESULTS	The 46 women allocated to anastrozole had a modest BMD increase of 12 % ( -01 to 26 ) at the spine compared with a 39 % ( 26 to 52 ) increase for the 60 women allocated to placebo ( p = 0006 ) .
RESULTS	For the total hip , a small 03 % ( -09 to 15 ) increase was noted for women allocated anastrozole compared with a 15 % ( 05 to 25 ) increase for women allocated placebo , but the difference was not significant ( p = 012 ) .
RESULTS	The most common adverse event reported was arthralgia ( stratum I : 94 placebo and 114 anastrozole ; stratum II : 39 placebo/placebo , 25 placebo/risedronate , 34 anastrozole/placebo , and 34 anastrozole/risedronate ; stratum III : 21 placebo/risedronate , 17 anastrozole/risedronate ) .
RESULTS	Other adverse events included hot flushes , alopecia , abdominal pain , and back pain .
CONCLUSIONS	Risedronate counterbalances the effect of anastrozole-induced bone loss in osteopenic and osteoporotic women and might be offered in combination with anastrozole treatment to provide an improved risk-benefit profile .
BACKGROUND	Cancer Research UK ( C569/A5032 ) , National Health and Medical Research Council Australia ( GNT300755 , GNT569213 ) , Sanofi-Aventis , and AstraZeneca .

###24962246
BACKGROUND	Exercise and diet are the cornerstones for the treatment of obesity in obese children and adolescents .
BACKGROUND	However , compensatory changes in appetite and energy expenditure elicited by exercise and dieting make it hard to maintain a reduced weight over the longterm .
BACKGROUND	The anorexic effect of hypoxia can be potentially utilized to counteract this compensatory increase , thereby enhancing the success of weight loss .
BACKGROUND	The purpose of the study is to assess the effectiveness of four week intermittent hypoxia exposure added to a traditional exercise and diet intervention on inducing short - and longterm weight loss in obese adolescents .
METHODS	In this randomized parallel group controlled clinical trial , 40 obese adolescents ( 20 boys and 20 girls , 11 to 15-years-old ) , will be recruited from a summer weight loss camp at the Shanghai University of Sport , China .
METHODS	Participants will be stratified by gender and randomly assigned to either the control group or the hypoxia group .
METHODS	During the four-week intervention period , both groups will exercise and eat a balanced diet .
METHODS	Additionally , the control group will sleep in normal conditions , while the hypoxia group will sleep in a normobaric hypoxia chamber ( sleep high and train low ) .
METHODS	The primary outcome will be body composition and the main secondary outcomes will be the circulating levels of appetite regulatory gastrointestinal hormones .
METHODS	All the outcome measures will be assessed at baseline , after the four-week intervention , and at two months follow-up .
CONCLUSIONS	Our study will be the first to evaluate the effectiveness of ` sleep high and train low ' on short - and longterm weight loss among obese adolescents .
CONCLUSIONS	A potential mechanism for the appetite regulatory effect of hypoxia will also be explored .
CONCLUSIONS	The results of the study will provide an evidence-based recommendation for the use of hypoxia in a weight loss intervention among obese children and adolescents .
CONCLUSIONS	Furthermore , the clarification of mechanisms leading to weight loss in ` sleep high and train low ' might provide information for the development of new strategies in combating obesity .
BACKGROUND	This trial was registered on 10 January 2014 at the Chinese Clinical Trial Registry with the registration number : ChiCTR-TRC-14004106 .

###25475357
OBJECTIVE	Periprocedural myocardial injury ( PMI ) following percutaneous coronary intervention ( PCI ) has received great attention due to its significant association with mortality and morbidity .
OBJECTIVE	Accordingly , cardioprotection during PCI is one of the important therapeutic concerns .
OBJECTIVE	Regarding the potential cardiovascular benefits of pentoxifylline this study was performed to evaluate whether the pretreatment pentoxifylline could reduce PMI in patients who are undergoing elective PCI .
METHODS	A randomized clinical trial on 85 patients undergoing elective PCI was performed .
METHODS	The intervention group ( n = 41 ) received 1200 mg pentoxifylline in divided doses plus the standard treatment before PCI , while the control group ( n = 44 ) received the standard treatment .
METHODS	For assessing myocardial damage during PCI , the levels of CK-MB and troponin-I were measured at baseline , 8 , and 24 h after the procedure .
METHODS	Then , patients were followed up for a 1-month period regarding the major adverse cardiac effect .
RESULTS	Comparing with the control group , no significant change of CK-MB at 8 ( p = 0.315 ) and 24 h ( p = 0.896 ) after PCI was documented in pentoxifylline group .
RESULTS	Similarly , no significant change was found in troponin-I at 8 ( p = 0.141 ) and 24 h ( p = 0.256 ) after PCI .
CONCLUSIONS	This study could not support the pretreatment with pentoxifylline in the prevention of PMI in patients undergoing elective PCI .
CONCLUSIONS	However , the trend was toward the potential benefit of pentoxifylline .

###24952857
BACKGROUND	Hospital admissions for acute decompensated heart failure ( ADHF ) are frequent and are accompanied by high percentages of mortality and readmissions .
BACKGROUND	Brain natriuretic peptide ( BNP ) and the inactive N-terminal fragment of its precursor proBNP ( NT-proBNP ) are currently the best predictors of prognosis in heart failure ( HF ) patients .
BACKGROUND	In the setting of chronic HF , studies that performed guidance of therapy by NT-proBNP have had only limited success .
BACKGROUND	For patients with ADHF , retrospective studies have shown that a reduction in NT-proBNP of 30 % during admission is a significant predictor of HF readmissions and mortality .
BACKGROUND	These data suggest a role for NT-proBNP guidance in the setting of ADHF admissions .
METHODS	The PRIMA II is an investigator-initiated , multicenter , randomized , controlled , prospective 2-arm trial that investigates the impact of inhospital guidance for ADHF treatment by a predefined NT-proBNP target ( > 30 % reduction during admission ) on the reduction of readmission and mortality rates within 180 days .
METHODS	Consenting ADHF patients with NT-proBNP levels of > 1,700 ng/L are eligible .
METHODS	After achieving clinical stability , a total of 340 patients are randomized to either NT-proBNP-guided or conventional treatment ( 1:1 ) .
METHODS	The primary end point is dual , that is , a composite of all-cause mortality and readmission for HF in 180 days and the number of days alive out of hospital in 180 days .
METHODS	Secondary end points are readmissions and/or mortality in 180 days , cost effectiveness of hospitalization days in 180 days , readmissions and mortality in 90 days , and quality of life .
CONCLUSIONS	The PRIMA II trial aims at providing scientific evidence for the use of NT-proBNP-guided therapy compared with conventional treatment in patients admitted for ADHF .

###24844551
BACKGROUND	We aimed to examine the effects of topical hypothermia on inflammatory markers in patients undergoing coronary artery bypass surgery .
METHODS	Fifty patients undergoing isolated coronary artery bypass surgery were included the study .
METHODS	They were randomised to two groups .
METHODS	Mild hypothermic cardiopulmonary bypass ( 28-32C ) was performed on both groups using standardised anaesthesiology and surgical techniques .
METHODS	Furthermore , topical cooling with 4C saline was performed on patients in group I.
METHODS	We recorded peri-operative and intra-operative results of blood samples , pre-operative and postoperative outcomes of electrocardiography and echocardiography , diaphragm levels on X-ray , and the necessity of positive inotropic medication and intra-aortic balloon pump ( IABP ) .
RESULTS	Time-dependent changes in blood samples were compared between the two groups .
RESULTS	The changes on complement 3 ( C3 ) and TNF - levels were more significant in group I than group II ( p < 0.05 and p < 0.001 , respectively ) .
RESULTS	Spontaneous restoration rate of sinus rhythm was higher in group II than group I ( 80 vs 32 % , p < 0.01 ) .
RESULTS	Atrial fibrillation was seen in six patients in group I and one patient in group II ( p < 0.05 ) .
RESULTS	IABP was performed on four patients ( 16 % ) in group I ( p < 0.05 ) .
RESULTS	Diaphragmatic paralysis was seen in seven patients in group I but not in group II ( p < 0.01 ) .
RESULTS	Partial pericardiotomy rates were compared within the groups but there was no statistically significant difference ( p > 0.05 ) .
RESULTS	One patient in group I died on the 18th postoperative day , but operative mortality rate was not statistically significant between the two groups ( p > 0.05 ) .
CONCLUSIONS	Topical hypothermia had a negative impact on inflammatory markers and postoperative morbidities .

###25140958
BACKGROUND	Bedaquiline ( Sirturo , TMC207 ) , a diarylquinoline that inhibits mycobacterial ATP synthase , has been associated with accelerated sputum-culture conversion in patients with multidrug-resistant tuberculosis , when added to a preferred background regimen for 8 weeks .
METHODS	In this phase 2b trial , we randomly assigned 160 patients with newly diagnosed , smear-positive , multidrug-resistant tuberculosis to receive either 400 mg of bedaquiline once daily for 2 weeks , followed by 200 mg three times a week for 22 weeks , or placebo , both in combination with a preferred background regimen .
METHODS	The primary efficacy end point was the time to sputum-culture conversion in liquid broth .
METHODS	Patients were followed for 120 weeks from baseline .
RESULTS	Bedaquiline reduced the median time to culture conversion , as compared with placebo , from 125 days to 83 days ( hazard ratio in the bedaquiline group , 2.44 ; 95 % confidence interval , 1.57 to 3.80 ; P < 0.001 by Cox regression analysis ) and increased the rate of culture conversion at 24 weeks ( 79 % vs. 58 % , P = 0.008 ) and at 120 weeks ( 62 % vs. 44 % , P = 0.04 ) .
RESULTS	On the basis of World Health Organization outcome definitions for multidrug-resistant tuberculosis , cure rates at 120 weeks were 58 % in the bedaquiline group and 32 % in the placebo group ( P = 0.003 ) .
RESULTS	The overall incidence of adverse events was similar in the two groups .
RESULTS	There were 10 deaths in the bedaquiline group and 2 in the placebo group , with no causal pattern evident .
CONCLUSIONS	The addition of bedaquiline to a preferred background regimen for 24 weeks resulted in faster culture conversion and significantly more culture conversions at 120 weeks , as compared with placebo .
CONCLUSIONS	There were more deaths in the bedaquiline group than in the placebo group .
CONCLUSIONS	( Funded by Janssen Pharmaceuticals ; TMC207-C208 ClinicalTrials.gov number , NCT00449644 . )

###24387685
BACKGROUND	The conventional sequence when using supraglottic airway devices is insertion , cuff inflation and fixation .
BACKGROUND	Our hypothesis was that a tighter fit of the cuff and tip could be achieved with a consequently lower incidence of air leak , better separation of gastrointestinal and respiratory tracts and less airway morbidity if the device were first affixed and the cuff then inflated .
METHODS	Our clinical review board approved the study ( public registry number DRKS00003174 ) .
METHODS	An LMA Supreme was inserted into 184 patients undergoing lower limb arthroscopy in propofol-remifentanil anaesthesia who were randomly assigned to either the control ( inflation then fixation ; n = 92 ) or study group ( fixation then inflation ; n = 92 ) .
METHODS	The cuff was inflated to 60 cmH2O .
METHODS	The patients ' lungs were ventilated in pressure-controlled mode with 5 cmH2O PEEP , Pmax to give 6mlkg-1 tidal volume , and respiratory rate adjusted to end-tidal CO2 of 4.8 and 5.6 kPa .
METHODS	Correct cuff and tip position were determined by leak detection , capnometry trace , oropharyngeal leak pressure , suprasternal notch test , and lube-tube test .
METHODS	Bowl and cuff position and the presence of glottic narrowing were assessed by fiberscopic examination .
METHODS	Postoperative dysphagia , hoarseness and sore throat were assessed with a questionnaire .
METHODS	Ventilatory impairment was defined as a tidal volume < 6mlkg-1 with Pmax at oropharyngeal leak pressure , glottic narrowing was defined as an angle between the vocal cords under 16 degrees .
RESULTS	The incidence of incorrect device position ( 18 % vs. 21 % ) , failed ventilation ( 10 % vs. 9 % ) , leak pressure ( 24.8 vs. 25.2 cmH2O , p = 0.63 ) , failed lube-tube test ( 16.3 % vs. 17.6 % ) and glottic narrowing ( 19.3 % vs. 14.1 % , p = 0.35 ) was similar in both groups ( control vs. study , resp . )
RESULTS	When glottic narrowing occurred , it was more frequently associated with ventilatory impairment in the control group ( 77 % vs. 39 % ; p = 0.04 ) .
RESULTS	Airway morbidity was more common in the control group ( 33 % vs. 19 % ; p < 0.05 ) .
CONCLUSIONS	Altering the sequence of cuff inflation and device fixation does not affect device position , oropharyngeal leak pressures or separation of gastrointestinal and respiratory tracts .
CONCLUSIONS	It reduces the incidence of glottic narrowing with impaired ventilation and also perioperative airway morbidity .

###24674663
BACKGROUND	A prophylactic human papillomavirus ( HPV ) vaccine targeting oncogenic HPV types in addition to HPV-16 and -18 may broaden protection against cervical cancer .
BACKGROUND	Two Phase I/II , randomized , controlled studies were conducted to compare the immunogenicity and safety of investigational tetravalent HPV L1 virus-like particle ( VLP ) vaccines , containing VLPs from two additional oncogenic genotypes , with the licensed HPV-16 / 18 AS04-adjuvanted vaccine ( control ) in healthy 18-25 year-old women .
METHODS	In one trial ( NCT00231413 ) , subjects received control or one of 6 tetravalent HPV-16 / 18/31/45 AS04 vaccine formulations at months ( M ) 0,1,6 .
METHODS	In a second trial ( NCT00478621 ) , subjects received control or one of 5 tetravalent HPV-16 / 18/33/58 vaccines formulated with different adjuvant systems ( AS04 , AS01 or AS02 ) , administered on different schedules ( M0 ,1,6 or M0 ,3 or M0 ,6 ) .
RESULTS	One month after the third injection ( Month 7 ) , there was a consistent trend for lower anti-HPV-16 and -18 geometric mean antibody titers ( GMTs ) for tetravalent AS04-adjuvanted vaccines compared with control .
RESULTS	GMTs were statistically significantly lower for an HPV-16 / 18/31/45 AS04 vaccine containing 20/20/10 / 10 g VLPs for both anti-HPV-16 and anti-HPV-18 antibodies , and for an HPV-16 / 18/33/58 AS04 vaccine containing 20/20/20 / 20 g VLPs for anti-HPV-16 antibodies .
RESULTS	There was also a trend for lower HPV-16 and -18 - specific memory B-cell responses for tetravalent AS04 vaccines versus control .
RESULTS	No such trends were observed for CD4 ( + ) T-cell responses .
RESULTS	Immune interference could not always be overcome by increasing the dose of HPV-16 / 18 L1 VLPs or by using a different adjuvant system .
RESULTS	All formulations had acceptable reactogenicity and safety profiles .
RESULTS	Reactogenicity in the 7-day post-vaccination period tended to increase with the introduction of additional VLPs , especially for formulations containing AS01 .
CONCLUSIONS	HPV-16 and -18 antibody responses were lower when additional HPV L1 VLPs were added to the HPV-16 / 18 AS04-adjuvanted vaccine .
CONCLUSIONS	Immune interference is a complex phenomenon that can not always be overcome by changing the antigen dose or adjuvant system .

###24733408
BACKGROUND	In a multicenter , double-blind , randomized , parallel-group , placebo-controlled , single-dose study ( n = 1555 ) , a fixed combination of acetaminophen 500mg , acetylsalicylic acid 500mg , and caffeine 130mg ( AAC ) was compared with ibuprofen 400mg ( IB ) and placebo ( PLA ) for acute treatment of migraine .
METHODS	An exploratory post-hoc analysis compared AAC with IB and PLA in the subset of patients with severe pain at baseline ( n = 660 ) .
RESULTS	At most time points , AAC and IB relieved the pain and associated symptoms of severe migraine significantly better than PLA ( p0 .05 ) .
RESULTS	AAC was significantly superior to IB for pain relief at 45 minutes and at one , two , three , and four hours postdose ( p < 0.04 ) ; pain intensity difference from one hour through three hours ( p < 0.05 ) ; headache response at two hours ( p = 0.04 ) ; functional disability reduced to little or none at three hours ( p = 0.013 ) ; freedom from phonophobia at three hours ( p = 0.04 ) and photophobia at 15 minutes postdose ( p = 0.03 ) ; and use of rescue medication ( p = 0.018 ) .
RESULTS	AAC patients also reported meaningful pain relief 16 minutes faster than IB patients ( 132 minutes vs 148 minutes , p = 0.026 ) .
CONCLUSIONS	In patients with severe baseline migraine pain , AAC and IB are significantly more effective than PLA , and AAC provides significantly faster and more effective pain relief than IB .

###25891550
OBJECTIVE	Determine whether MRI activity 6 months after treatment initiation in the Controlled High-Risk Subjects Avonex Multiple Sclerosis Prevention Study ( CHAMPS ) predicted progression to clinically definite multiple sclerosis ( CDMS ) over the subsequent 30 months in intramuscular interferon beta-1a ( IM IFN-1a ) - treated patients vs placebo-treated patients .
METHODS	CHAMPS patients were randomized to once-weekly IM IFN-1a 30 g or placebo for up to 36 months .
METHODS	MRI was performed every 6 months until CDMS confirmation .
METHODS	Patient groups were defined based on new T2 and/or Gd + lesions at 6 months .
RESULTS	Thirteen IM IFN-1a patients ( 6.7 % ) and 24 placebo patients ( 12.6 % ) developed CDMS prior to month 6 and did not undergo the 6-month MRI .
RESULTS	At 6 months , 29.7 % of IM IFN-1a-treated patients vs 40.9 % of placebo-treated patients were defined as having high MRI activity levels ( 2 new T2 and/or 2 Gd + lesions ) .
RESULTS	In this subgroup , estimated cumulative probabilities of CDMS were similar between groups ( HR = 0.88 [ 0.44-1 .77 ] , p = 0.7227 ) .
RESULTS	A significant treatment response was seen for patients with < 2 new T2 and < 2 Gd + lesions at 6 months ( HR = 0.39 [ 0.19-0 .82 ] , p = 0.0120 ) .
CONCLUSIONS	MRI scans 6 months after IM IFN-1a initiation in CIS patients predict early treatment non-response .
CONCLUSIONS	Standardized scanning and monitoring may facilitate early disease management .

###25577973
OBJECTIVE	Blood loss and blood substitution are associated with higher morbidity after major abdominal surgery .
OBJECTIVE	During major liver resection low local venous pressure decreases blood loss .
OBJECTIVE	Ambiguity persists concerning the impact of local venous pressure on blood loss during open radical cystectomy .
OBJECTIVE	We determined the association between intraoperative blood loss and pelvic venous pressure as well as factors affecting pelvic venous pressure .
METHODS	In this single center , double-blind , randomized trial pelvic venous pressure was measured in 82 patients in a norepinephrine-low volume group and in 81 controls with liberal hydration .
METHODS	As secondary analysis patients from each arm were stratified into subgroups with pelvic venous pressure less than 5 mm Hg , or 5 or greater as measured after cystectomy , which is the optimal cutoff for identifying patients with relevant blood loss according to the Youden index .
RESULTS	Median blood loss was 800 ml ( range 300 to 1,600 ) in 55 of 163 patients ( 34 % ) with pelvic venous pressure less than 5 mm Hg and 1,200 ml ( range 400 to 3,000 ) in 108 of 163 ( 66 % ) with pelvic venous pressure 5 mm Hg or greater ( p < 0.0001 ) .
RESULTS	Pelvic venous pressure less than 5 mm Hg was measured in 42 of 82 patients ( 51 % ) in the norepinephrine-low volume group and in 13 of 81 controls ( 16 % ) ( p < 0.0001 ) .
RESULTS	Pelvic venous pressure decreased significantly after removing abdominal packing and abdominal lifting in each group at all time points , that is at the beginning and end of pelvic lymph node dissection , and the end of cystectomy ( p < 0.0001 ) .
RESULTS	No correlation was detected between pelvic venous pressure and central venous pressure .
CONCLUSIONS	Blood loss was significantly decreased in patients with low pelvic venous pressure .
CONCLUSIONS	Factors affecting pelvic venous pressure were fluid management and abdominal packing .

###25964257
OBJECTIVE	Survivors of breast cancer may experience deterioration of physical function .
OBJECTIVE	This is important because poor physical function may be associated with premature mortality , injurious falls , bone fracture , and disability .
OBJECTIVE	We conducted a post hoc analysis to explore the potential efficacy of slowly progressive weight lifting to reduce the incidence of physical function deterioration among survivors of breast cancer .
METHODS	Between October 2005 and August 2008 , we conducted a single-blind , 12-month , randomized controlled trial of twice-per-week slowly progressive weight lifting or standard care among 295 survivors of nonmetastatic breast cancer .
METHODS	In this post hoc analysis of data from the Physical Activity and Lymphedema Trial , we examined incident deterioration of physical function after 12 months , defined as a 10-point decrease in the physical function subscale of the Medical Outcomes Short-Form 36-item questionnaire .
RESULTS	The proportion of participants who experienced incident physical function deterioration after 12 months was 16.3 % ( 24/147 ) in the control group and 8.1 % ( 12/148 ) in the weight lifting group ( relative risk , 0.49 ; 95 % CI , 0.25 to 0.96 ; P = .04 ) .
RESULTS	No serious or unexpected adverse events occurred that were related to weight lifting .
CONCLUSIONS	Slowly progressive weight lifting compared with standard care reduced the incidence of physical function deterioration among survivors of breast cancer .
CONCLUSIONS	These data are hypothesis generating .
CONCLUSIONS	Future studies should directly compare the efficacy of weight lifting with other modalities of exercise , such as brisk walking , to appropriately inform the development of a confirmatory study designed to preserve physical function among survivors of breast cancer .

###24390400
BACKGROUND	To evaluate the effect of intracameral lidocaine anesthesia on macular thickness and macular ganglion cell-inner plexiform layer ( GC-IPL ) thickness following uneventful phacoemusification in healthy subjects .
METHODS	This is a prospective , randomized and double - masked study .
METHODS	One hundred eyes of 74 consecutive patients were randomized to receive intracameral preservative-free lidocaine 1 % ( intracameral lidocaine group ) or intracameral injection of balanced salt solution ( sham injection group ) at the time of the phacoemulsification surgery .
METHODS	Preoperative and postoperative macular thickness analyses with spectral domain optical coherence tomography ( SD-ODT ) were performed and the results between the two groups were compared .
RESULTS	Postoperatively , both the central foveal thickness ( CFT ) and the thickness of perifoveal macula were significantly improved in both groups ( p < 0.001 ) .
RESULTS	There was no statistically significant difference between CFT and the inner and outer macular zone thicknesses of the two groups at any follow-up time .
RESULTS	In both groups , GC-IPL thickness was significantly increased at the first week and first month visits ( p < 0.001 ) .
RESULTS	There was no statistically significant difference between GC-IPL thickness measurements of the two groups at any follow-up time .
CONCLUSIONS	The current study demonstrated that supplementary intracameral lidocaine 1 % did not cause more macular thickening than the intracameral sham injection during a follow-up period of 3months .
CONCLUSIONS	The present study also showed a tendency for a transient increase in high definition SD-OCT-based GC-IPL thickness measurements within a few months following cataract surgery under both intracameral lidocaine anesthesia and intracameral sham injection .

###25557853
OBJECTIVE	In the current analysis due to the mechanism of effect , we evaluated the treatment benefit of duloxetine 40 mg comparing with paroxetine 20 mg , based on its effects on personal distress and interpersonal difficulty related to ejaculation , perceived control over ejaculation , and satisfaction with sexual intercourse , as well as the patient-reported global impression of change in premature ejaculation ( PE ) and the effect on intravaginal ejaculatory latency times ( IELT ) in men with premature ejaculation .
METHODS	The study included 80 married male patients diagnosed with lifelong PE .
METHODS	A total of 80 patients were randomly distributed into two groups of 40 patients each .
METHODS	Group 1 patients received 40 mg duloxetine once a day for a month .
METHODS	Group 2 patients received 20 mg paroxetine once a day for a month .
METHODS	International index of erectile function questionnaire ( IIEF ) and IELT and PE profile were recorded before and after treatment .
RESULTS	Comparing the groups ' mean treatment IELT , there was no difference between groups .
RESULTS	The IELT increase from baseline to treatment was 117 % in the duloxetine group ( P < 0.001 ) and 126 % in the paroxetine group ( P < 0.001 ) .
RESULTS	There was no statistical difference between two groups in terms of IELT increase ( P > 0.05 ) .
RESULTS	Also , there was no statistically significant difference between two groups at baseline IIEF to treatment IIEF scores .
RESULTS	All PEP measures improved significantly with duloxetine and paroxetine groups ( P < 0.001 ) .
CONCLUSIONS	We think that duloxetine is safe and effective for the treatment for premature ejaculation .

###24621441
BACKGROUND	Dietary supplements are widely used by cancer survivors .
BACKGROUND	However , health effects among older cancer survivors are unclear .
METHODS	We used the Iowa Women 's Health Study , a prospective cohort study with 2,118 postmenopausal women with a confirmed cancer diagnosis ( 1986-2002 ) , to evaluate the association between postdiagnosis dietary supplement use assessed in 2004 and subsequent all-cause mortality .
METHODS	Risk of death was evaluated using multivariable-adjusted Cox proportional hazards regression .
METHODS	We performed stratified analyses by diet quality score , dietary micronutrient intake , and perceived general health .
RESULTS	Through 2010 , 608 deaths were identified .
RESULTS	Approximately 85 % of the cancer survivors used dietary supplements .
RESULTS	Overall supplement use and multivitamin use were not associated with mortality .
RESULTS	Iron supplement use was associated with 39 % higher risk of death [ 95 % confidence interval ( CI ) , 1.09-1 .77 ] .
RESULTS	This association was stronger among survivors with deteriorating general health .
RESULTS	Folic acid supplement use was associated with higher risk of death , only among survivors reporting low-quality diets ( HR , 2.33 ; 95 % CI , 1.33-4 .08 ; P interaction = 0.006 ) .
RESULTS	Multivitamin use and using a greater number of supplements was associated with a trend towards higher mortality only among those with poor diet quality .
RESULTS	Using vitamin E supplements in combination with multivitamin was associated with lower risk of death only among survivors with higher dietary vitamin E intake ( HR , 0.61 ; 95 % CI , 0.39-0 .94 ; P interaction = 0.02 ) .
CONCLUSIONS	Postdiagnosis supplement use was associated with higher mortality among older female cancer survivors with poor general health and/or poor dietary intake .
CONCLUSIONS	The association between postdiagnosis dietary supplement use and mortality may differ by diet quality and health status among older female cancer survivors .

###24448103
OBJECTIVE	This post hoc analysis assessed the efficacy of desvenlafaxine 50 mg/day for treating major depressive disorder in perimenopausal versus postmenopausal women enrolled in a 10-week , double-blind , placebo-controlled study .
METHODS	Perimenopausal and postmenopausal women ( 40-70 y ) diagnosed with major depressive disorder were randomly assigned to receive desvenlafaxine 50 mg/day or placebo .
METHODS	Changes from baseline in the primary efficacy variable ( 17-item Hamilton Rating Scale for Depression [ HAM-D17 ] score , week 8 ) and in other secondary efficacy variables ( Sheehan Disability Scale and Menopause Rating Scale ) were analyzed using analysis of covariance with treatment , region , and baseline in the model .
METHODS	Clinical Global Impressions-Improvement Scale was analyzed with the Cochran-Mantel-Haenszel test .
METHODS	Response and remission rates were evaluated using logistic regression with treatment , region , and baseline HAM-D17 in the model .
RESULTS	Of 426 women ( desvenlafaxine , n = 216 ; placebo , n = 210 ) included in this analysis , 135 ( 32 % ) were perimenopausal and 291 ( 68 % ) were postmenopausal at baseline .
RESULTS	In both subgroups , improvement from baseline in HAM-D17 scores was significantly greater for desvenlafaxine 50 mg/day than for placebo .
RESULTS	Menopause status and time since menopause did not significantly affect HAM-D17 total score .
RESULTS	The drug-placebo difference in Sheehan Disability Scale scores was significant in perimenopausal women ( -9.3 vs. -5.1 , P < 0.001 ) but not in postmenopausal women ( -8.8 vs. -8.1 ) .
RESULTS	Menopause Rating Scale and Clinical Global Impressions-Improvement Scale scores were significantly improved with desvenlafaxine in postmenopausal women .
CONCLUSIONS	Desvenlafaxine 50 mg/day is effective in treating depression in both perimenopausal and postmenopausal women .
CONCLUSIONS	Placebo response on measures of functional impairment is lower in perimenopausal women than in postmenopausal women , resulting in a greater apparent treatment benefit with desvenlafaxine among perimenopausal women .

###24863156
BACKGROUND	Large-scale randomized clinical trials are needed to assess the role of Roux-en-Y gastric bypass ( RYGB ) in treating patients with type 2 diabetes mellitus ( T2DM ) .
BACKGROUND	Recruitment challenges must be understood .
METHODS	One hundred twenty participants were needed for a prospective randomized controlled trial investigating treatments for hyperglycemia and cardiovascular disease risk factors in patients with T2DM .
METHODS	The trial had two arms-intensive medical management plus a rigorous lifestyle intervention ( LS/IMM ) versus LS/IMM with RYGB .
METHODS	Medical inclusion criteria included glycosylated hemoglobin ( HbA1c ) 8.0 % while under the care of a physician and body mass index ( BMI ) 30.0-39 .9 kg/m ( 2 ) .
METHODS	Another inclusion criterion was expressed willingness to accept randomization and participate fully .
METHODS	Varied recruitment strategies were employed at four academic hospitals in the USA and Taiwan , including referrals , mass media , direct mail to patients drawn from a practice-based database , and direct mail to commercial mailing lists .
RESULTS	Between February 2008 and December 2011 , 2,648 candidates were phone-screened and 240 were screened on site ; 120 participants were eventually randomized .
RESULTS	Impediments included stringent medical inclusion criteria and a lack of equipoise ( i.e. , strong beliefs or preferences ) among patients and their personal community-based physicians .
RESULTS	To meet timeline requirements , the upper limit for BMI was increased from 34.9 to 39.9 kg/m ( 2 ) and an additional site was added .
CONCLUSIONS	We successfully recruited 120 participants with poorly controlled T2DM and mild to moderate obesity .
CONCLUSIONS	Participants had to be willing to accept randomization to either surgical or nonsurgical treatments .
CONCLUSIONS	Recruitment took 4 years .

###24687576
OBJECTIVE	The aim of this study was to evaluate the effects of pre-warmed ( approximately 41 C ) intravenous fluids ( IV ) on perioperative hypothermia and postoperative shivering in female patients undergoing short , ambulatory urological surgery under monitored anesthesia care ( MAC ) .
METHODS	Patients between the ages of 35 and 80 years were randomly assigned to either the pre-warmed ( n = 27 ) or the room temperature ( n = 26 ) group .
METHODS	According to group allocation , either pre-warmed IV fluids that had been stored in a warming cabinet for at least 8 h or room temperature IV fluids were administered intraoperatively up to approximately 600-700 ml , including a bolus infusion of 10 ml/kg within 20 min .
METHODS	Perioperative core temperatures at the tympanic membrane , postoperative shivering , subjective thermal comfort , and the use of forced-air warming interventions in the post-anesthesia care unit ( PACU ) were recorded .
RESULTS	Mean core temperatures were significantly higher in the pre-warmed group than they were in the room temperature group after 10 ml/kg preload fluid was administered , at the end of the operation , and on admission to the PACU ( p = 0.004 , p = 0.02 , and p = 0.008 , respectively ) .
RESULTS	The incidence of hypothermia ( < 36 C ) was significantly lower in the pre-warmed group ( n = 4 ) than in the room temperature group ( n = 11 , p = 0.035 ) upon PACU admission .
RESULTS	The postoperative shivering incidence was also significantly lower in the pre-warmed group ( n = 2 ) than in the room temperature group ( n = 8 , p = 0.039 ) .
CONCLUSIONS	Infusion of pre-warmed IV fluid improved the postoperative recovery profile by decreasing hypothermia and shivering in female patients undergoing short , ambulatory urological surgery under MAC .

###25300285
OBJECTIVE	Studies have indicated a blood pressure ( BP ) - lowering effect of milk-derived peptides in non-diabetic individuals , but the cardiometabolic effects of such peptides in patients with type 2 diabetes ( T2D ) are not known .
OBJECTIVE	We investigated the effect of milk fermented with Lactobacillus helveticus on BP , glycaemic control and cardiovascular risk factors in T2D .
METHODS	A randomised , double-blinded , prospective , placebo-controlled study .
METHODS	In one arm of a factorial study design , 41 patients with T2D were randomised to receive 300 ml milk fermented with L. helveticus ( Cardi04 yogurt ) ( n = 23 ) or 300 ml artificially acidified milk ( placebo yogurt ) ( n = 18 ) for 12 weeks .
METHODS	BPs were measured over 24-h , and blood samples were collected in the fasting state and during a meal test before and after the intervention .
RESULTS	Cardi04 yogurt did not reduce 24-h , daytime or nighttime systolic or diastolic BPs compared with placebo ( P > 0.05 ) .
RESULTS	Daytime and 24-h heart rate ( HR ) were significantly reduced in the group treated by Cardi04 yogurt compared with the placebo group ( P < 0.05 for both ) .
RESULTS	There were no differences in HbA1c , plasma lipids , C-reactive protein , plasminogen activator inhibitor-1 , tumour necrosis factor alpha , tissue-type plasminogen activator : Ag , and von Willebrand factor : Ag between the groups .
RESULTS	The change in fasting blood glucose concentration differed significantly between the two groups with a larger increase in the placebo group ( P < 0.05 ) .
CONCLUSIONS	Ingestion of milk fermented with L. helveticus compared with placebo for 12 weeks did not significantly reduce BP in patients with T2D .
CONCLUSIONS	Our finding of lower HRs and fasting plasma glucose levels in T2D patients during ingestion of fermented milk needs further validation .

###24295873
OBJECTIVE	Suboptimal virologic response to nucleos ( t ) ide analogs may represent a significant risk factor for resistance development in patients with chronic hepatitis B virus infection ; treatment options have not been well studied .
OBJECTIVE	We evaluated long-term efficacy and safety of tenofovir alone and in combination with emtricitabine in a prospective , placebo-controlled trial in patients who remained viremic on adefovir therapy .
METHODS	Hepatitis B e antigen-positive and - negative patients with hepatitis B virus DNA 1000 copies/ml despite up to 96 weeks of adefovir were randomized to double-blind tenofovir or emtricitabine/tenofovir for 168 weeks .
METHODS	Patients with hepatitis B virus DNA 400 copies/ml ( 69IU/ml ) at or after week 24 could switch to open-label emtricitabine/tenofovir .
RESULTS	Overall , 90/105 ( 86 % ) patients ( 46/53 tenofovir and 44/52 emtricitabine/tenofovir ) completed the 168-week study period , including 74/105 ( 70 % ) patients ( 35/53 tenofovir and 39/52 emtricitabine/tenofovir ) who completed the study on their initial randomized treatment .
RESULTS	Long-term viral suppression ( hepatitis B virus DNA < 400 copies/ml ) was maintained at week 168 in 84 % and 82 % of patients receiving either emtricitabine/tenofovir combination or tenofovir monotherapy , respectively ( non-completer equal to failure analysis ) .
RESULTS	Baseline viral load as well as the presence of lamivudine and/or adefovir resistance-associated mutations at baseline had no impact on long-term treatment response .
RESULTS	No resistance to tenofovir was observed through 168 weeks .
RESULTS	Both treatments had a favorable safety profile .
CONCLUSIONS	Tenofovir monotherapy is as effective as emtricitabine/tenofovir combination therapy in maintaining long-term viral suppression in patients with a suboptimal response to adefovir , and is well tolerated in this population .

###24865166
OBJECTIVE	To investigate the effectiveness of a school based intervention to increase physical activity , reduce sedentary behaviour , and increase fruit and vegetable consumption in children .
METHODS	Cluster randomised controlled trial .
METHODS	60 primary schools in the south west of England .
METHODS	Primary school children who were in school year 4 ( age 8-9 years ) at recruitment and baseline assessment , in year 5 during the intervention , and at the end of year 5 ( age 9-10 ) at follow-up assessment .
METHODS	The Active for Life Year 5 ( AFLY5 ) intervention consisted of teacher training , provision of lesson and child-parent interactive homework plans , all materials required for lessons and homework , and written materials for school newsletters and parents .
METHODS	The intervention was delivered when children were in school year 5 ( age 9-10 years ) .
METHODS	Schools allocated to control received standard teaching .
METHODS	The pre-specified primary outcomes were accelerometer assessed minutes of moderate to vigorous physical activity per day , accelerometer assessed minutes of sedentary behaviour per day , and reported daily consumption of servings of fruit and vegetables .
RESULTS	60 schools with more than 2221 children were recruited ; valid data were available for fruit and vegetable consumption for 2121 children , for accelerometer assessed physical activity and sedentary behaviour for 1252 children , and for secondary outcomes for between 1825 and 2212 children for the main analyses .
RESULTS	None of the three primary outcomes differed between children in schools allocated to the AFLY5 intervention and those allocated to the control group .
RESULTS	The difference in means comparing the intervention group with the control group was -1.35 ( 95 % confidence interval -5.29 to 2.59 ) minutes per day for moderate to vigorous physical activity , -0.11 ( -9.71 to 9.49 ) minutes per day for sedentary behaviour , and 0.08 ( -0.12 to 0.28 ) servings per day for fruit and vegetable consumption .
RESULTS	The intervention was effective for three out of nine of the secondary outcomes after multiple testing was taken into account : self reported time spent in screen viewing at the weekend ( -21 ( -37 to -4 ) minutes per day ) , self reported servings of snacks per day ( -0.22 ( -0.38 to -0.05 ) ) , and servings of high energy drinks per day ( -0.26 ( -0.43 to -0.10 ) ) were all reduced .
RESULTS	Results from a series of sensitivity analyses testing different assumptions about missing data and from per protocol analyses produced similar results .
CONCLUSIONS	The findings suggest that the AFLY5 school based intervention is not effective at increasing levels of physical activity , decreasing sedentary behaviour , and increasing fruit and vegetable consumption in primary school children .
CONCLUSIONS	Change in these activities may require more intensive behavioural interventions with children or upstream interventions at the family and societal level , as well as at the school environment level .
CONCLUSIONS	These findings have relevance for researchers , policy makers , public health practitioners , and doctors who are involved in health promotion , policy making , and commissioning services .
CONCLUSIONS	Trial registration Current Controlled Trials ISRCTN50133740 .

###24947057
OBJECTIVE	Central venous catheter ( CVC ) - related thrombosis and infections are frequently occurring complications in patients with hematological malignancies .
OBJECTIVE	At present , heparin is most often used as a locking solution .
OBJECTIVE	Trisodium citrate ( TSC ) had been shown to be a very effective antimicrobial catheter locking in hemodialysis patients .
OBJECTIVE	We performed a prospective randomized phase III multicenter trial to determine the efficacy of TSC as a locking solution compared to heparin in preventing CVC-related thrombosis and infections in patients with hematological malignancies .
RESULTS	Thirty-four episodes of CVC-related bloodstream infections ( CVC-BSI ) occurred in the 108 patients who were randomized to locking with heparin compared with 35 episodes in the 99 patients who were randomized to locking with TSC ( P = 0.654 ) .
RESULTS	We did find seven times more CVC-BSI with gram-negative rods in CVCs locked with heparin ( P = 0.041 ) .
RESULTS	The cumulative incidence of symptomatic thrombosis was 10 % in the heparin group and 5 % in the TSC group ( hazard ratio 0.525 ; 95 % confidence interval 0.182-1 .512 ) .
CONCLUSIONS	This study shows that locking with TSC in patients with hematological malignancies significantly reduced the incidence of CVC-BSI with gram-negative rods .
CONCLUSIONS	However , the incidence of CVC-BSI with coagulase-negative staphylococcus or CVC-related thrombosis was not reduced by TSC locking .

###25012289
BACKGROUND	C-reactive protein ( CRP ) binds to damaged cells , activates the classical complement pathway , is elevated in multiple inflammatory conditions , and provides prognostic information on risk of future atherosclerotic events .
BACKGROUND	It is controversial , however , as to whether inhibiting CRP synthesis would have any direct anti-inflammatory effects in humans .
RESULTS	A placebo-controlled study was used to evaluate the effects of ISIS 329993 ( ISIS-CRPR x ) on the acute-phase response after endotoxin challenge in 30 evaluable subjects .
RESULTS	Healthy adult males were randomly allocated to receive 6 injections over a 22-day period of placebo or active therapy with ISIS 329993 at 400 - or 600-mg doses .
RESULTS	Eligible subjects were subsequently challenged with a bolus of endotoxin ( 2 ng/kg ) .
RESULTS	Inflammatory and hematological biomarkers were measured before and serially after the challenge .
RESULTS	ISIS-CRPR x was well tolerated with no serious adverse events .
RESULTS	Median CRP levels increased more than 50-fold from baseline 24 hours after endotoxin challenge in the placebo group .
RESULTS	In contrast , the median increase in CRP levels was attenuated by 37 % ( 400 mg ) and 69 % ( 600 mg ) in subjects pretreated with ISIS-CRPR x ( P < 0.05 vs. placebo ) .
RESULTS	All other aspects of the acute inflammatory response were similar between treatment groups .
CONCLUSIONS	Pretreatment of subjects with ISIS-CRPR x selectively reduced the endotoxin-induced increase in CRP levels in a dose-dependent manner , without affecting other components of the acute-phase response .
CONCLUSIONS	These data demonstrate the specificity of antisense oligonucleotides and provide an investigative tool to further define the role of CRP in human pathological conditions .

###24920891
BACKGROUND	We recently reported that epithelial-mesenchymal transition ( EMT ) is active in the airways in chronic obstructive pulmonary disease ( COPD ) , suggesting presence of an active profibrotic and promalignant stroma .
BACKGROUND	With no data available on potential treatment effects , we undertook a blinded analysis of inhaled corticosteroids ( ICS ) effects versus placebo on EMT markers in previously obtained endobronchial biopsies in COPD patients , as a `` proof of concept '' study .
METHODS	Assessment of the effects of inhaled fluticasone propionate ( FP ; 500 g twice daily for 6 months ) versus placebo in 34 COPD patients ( 23 on fluticasone propionate and eleven on placebo ) .
METHODS	The end points were epidermal growth factor receptor ( EGFR ; marker of epithelial activation ) and the biomarkers of EMT : reticular basement membrane ( Rbm ) fragmentation ( `` hallmark '' structural marker ) , matrix metalloproteinase-9 ( MMP-9 ) cell expression , and S100A4 expression in basal epithelial and Rbm cells ( mesenchymal transition markers ) .
RESULTS	Epithelial activation , `` clefts/fragmentation '' in the Rbm , and changes in the other biomarkers all regressed on ICS , at or close to conventional levels of statistical significance .
RESULTS	From these data , we have been able to nominate primary and secondary end points and develop power calculations that would be applicable to a definitive prospective study .
CONCLUSIONS	Although only a pilot `` proof of concept '' study , this trial provided strong suggestive support for an anti-EMT effect of ICS in COPD airways .
CONCLUSIONS	A larger and fully powered prospective study is now indicated as this issue is likely to be extremely important .
CONCLUSIONS	Such studies may clarify the links between ICS use and better clinical outcomes and protection against lung cancer in COPD .

###25423958
BACKGROUND	The Radiation Reduction During Cardiac Catheterization Using Real-Time Monitoring study sought to examine the effect of a radiation detection device that provides real-time operator dose reporting through auditory feedback ( Bleeper Sv ; Vertec Scientific Ltd ; Berkshire , UK ) on patient dose and operator exposure during cardiac catheterization .
RESULTS	Between January 2012 and May 2014 , 505 patients undergoing coronary angiography , percutaneous coronary intervention , or both were randomized to use ( n = 253 ) or no use ( n = 252 ) of the Bleeper Sv radiation monitor .
RESULTS	Operator radiation exposure was measured in both groups using a second , silent radiation exposure monitoring device .
RESULTS	Mean patient age was 658 years , most patients ( 99 % ) were men , and 30 % had prior coronary artery bypass graft surgery .
RESULTS	Baseline clinical characteristics were similar in the 2 study groups .
RESULTS	Radial access was used in 18 % and chronic total occlusion percutaneous coronary intervention constituted 7 % of the total procedures .
RESULTS	Median procedure time was 17 ( 12-27 ) minutes for diagnostic angiography , 42 ( 28-70 ) minutes for percutaneous coronary intervention , and 27 ( 14-51 ) minutes in the overall study population , with similar distribution between the study groups .
RESULTS	First ( 9 [ 4-17 ] versus 14 [ 7-25 ] Sv ; P < 0.001 ) and second ( 5 [ 2-10 ] versus 7 [ 4-14 ] Sv ; P < 0.001 ) operator radiation exposure was significantly lower in the Bleeper Sv group .
RESULTS	Use of the device did not result in a significant reduction in patient radiation dose .
RESULTS	The effect of the Bleeper Sv device on operator radiation exposure was consistent among various study subgroups .
CONCLUSIONS	Use of a real-time radiation monitoring device that provides auditory feedback can significantly reduce operator radiation exposure during cardiac catheterization .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01510353 .

###24958605
OBJECTIVE	Aerobic exercise training is a recognized approach for improving functional capacity in COPD .
OBJECTIVE	People with greater disease severity often have difficulty achieving higher aerobic exercise training intensity .
OBJECTIVE	The effects of resistance training prior to aerobic training were examined to determine if this sequential approach was associated with greater gains in functional status than aerobic training alone or concurrent aerobic and resistance training .
METHODS	Patients were randomized to : 1 ) sequential resistance then aerobic training ( RT-then-AT ) ( 8 weeks resistance training followed by 8 weeks aerobic exercise training ) , 2 ) control group ( CE-then-AT + RT ) ( 8 weeks of ` sham ' training followed by 8 weeks concurrent aerobic and resistance training ) , 3 ) control group ( CE-then-AT ) ( 8 weeks ` sham ' training followed by 8 weeks aerobic training ) .
METHODS	Outcomes were assessed at study entry , after week 8 , and after week 16 : aerobic exercise performance ; muscle strength and endurance .
RESULTS	75 patients completed training : FEV1 % pred 40 10 , VO ( 2peak ) % predicted , 71 22 , fat-free mass index 19.5 3.1 .
RESULTS	RT-then-AT had greater acquisition of peripheral muscle endurance than CE-then-AT + RT and CE-then-AT , but improvements in aerobic exercise performance were similar .
RESULTS	Improvements in muscle strength were similar between RT-then-AT and CE-then-AT + RT. .
RESULTS	Sarcopenia was associated with poorer attendance , and lower aerobic and resistance training volumes .
CONCLUSIONS	Although the sequential approach to resistance and aerobic training yielded a greater increase in muscle endurance and higher resistance training volume compared to concurrent resistance and aerobic training , other training outcomes were similar between the two groups , thus the sequential approach is not clearly superior to the concurrent approach in severe COPD .
CONCLUSIONS	ClinicalTrials.gov Identifier : NCT01058213 .

###25262111
OBJECTIVE	The association between epicardial adipose tissue ( EAT ) volume and coronary artery disease ( CAD ) severity was evaluated , independent of traditional risk factors and coronary artery calcium ( CAC ) scores , in patients with diabetes type 2 ( DM-2 ) using cardiac computed tomography angiography ( CTA ) .
METHODS	A multivariate analysis was utilized to assess for an independent association after calculating EAT volume , CAD severity , and calcium scores in 92 patients with DM-II from the CTRAD study .
METHODS	We graded CAD severity as none ( normal coronaries ) , mild-moderate ( < 70 % stenosis ) , and severe ( 70 % or greater stenosis ) .
RESULTS	A total of 39 ( 42.3 % ) asymptomatic patients with diabetes did not have CAD ; 30.4 % had mild/moderate CAD ; and 27.1 % had severe CAD .
RESULTS	Mean EAT volume was highest in patients with severe CAD ( 143.14 cm ( 3 ) ) as compared to mild/moderate CAD ( 112.7 cm ( 3 ) ) , and no CAD ( 107.5 cm ( 3 ) ) ( p = 0.003 ) .
RESULTS	After adjustment of clinical risk factors , notably , CAC score , multivariate regression analysis showed EAT volume was an independent predictor of CAD severity in this sample ( odds ratio 11.2 , 95 % confidence interval 1.7-73 .8 , p = 0.01 ) .
CONCLUSIONS	Increasing EAT volume in asymptomatic patients with DM-II is associated with presence of severe CAD , independent of BMI and CAC , as well as traditional risk factors .

###24617000
OBJECTIVE	To evaluate the efficacy and safety of mite allergen specific immunotherapy ( SIT ) in treating children with allergic asthma .
METHODS	A total of 136 patients with mite allergy were recruited into the study .
METHODS	They were randomly divided into two groups : SIT group ( n = 66 ) and ST ( symptomatic therapy ) group ( n = 70 ) .
METHODS	They were investigated of SIT with standardized allergen vaccine or no SIT only symptomatic therapy respectively .
METHODS	Therapeutic evaluation index includes : asthma symptoms score , drug score , skin prick test , pulmonary function , serum specificity IgE ( sIgE ) and the new sensitization was also assessed .
METHODS	Local and systemic adverse reactions were used to evaluate the clinical safety .
RESULTS	Clinical symptom scores , drug scores , Lung function , and skin test result all improved significantly after the treatment with SIT compared to ST group ( P < 0.01 ) .
RESULTS	SIT groups do not have new sensitization and no fatal systemic reactions occurred .
CONCLUSIONS	The standardized dust mite allergen specific immunotherapy is efficacious and safe to Children with allergic asthma .
CONCLUSIONS	SIT can reduce house dust mites skin sensitivity and prevent new allergen appeared .

###25173772
BACKGROUND	No-rinse disposable wash gloves are increasingly implemented in health care to replace traditional soap and water bed baths without proper evaluation of ( cost ) effectiveness .
OBJECTIVE	To compare bed baths for effects on skin integrity and resistance against bathing and costs .
METHODS	Cluster randomized trial .
METHODS	Fifty six nursing home wards in the Netherlands .
METHODS	Participants : Five hundred adult care-dependent residents and 275 nurses from nursing home wards .
METHODS	The experimental condition ` washing without water ' consists of a bed bath with disposable wash gloves made of non-woven waffled fibers , saturated with a no-rinse , quickly vaporizing skin cleaning and caring lotion .
METHODS	The control condition is a traditional bed bath using soap , water , washcloths and towels .
METHODS	Both conditions were continued for 6 weeks .
METHODS	Outcome measures were prevalence of skin damage distinguished in two levels of severity : any skin abnormality/lesion and significant skin lesions .
METHODS	Additional outcomes : resistance during bed baths , costs .
RESULTS	Any skin abnormalities/lesions over time decreased slightly in the experimental group , and increased slightly in the control group , resulting in 72.7 % vs 77.6 % of residents having any skin abnormalities/lesions after 6 weeks , respectively ( p = 0.04 ) .
RESULTS	There were no differences in significant skin lesions or resistance after 6 weeks .
RESULTS	Mean costs for bed baths during 6 weeks per resident were estimated at 218.30 ( 95 % CI 150.52-286 .08 ) in the experimental group and 232.20 ( 95 % CI : 203.80-260 .60 ) in the control group ( difference 13.90 ( 95 % CI : -25.61 -53.42 ) .
CONCLUSIONS	Washing without water mildly protects from skin abnormalities/lesions , costs for preparing and performing bed baths do not differ from costs for traditional bed bathing .
CONCLUSIONS	Thus , washing without water can be considered the more efficient alternative .

###24745020
BACKGROUND	The aim of this study is to investigate the effectiveness of preemptive thoracic epidural analgesia ( TEA ) comparing conventional postoperative epidural analgesia on thoracotomy .
METHODS	Forty-four patients were randomized in to two groups ( preemptive : Group P , control : Group C ) .
METHODS	Epidural catheter was inserted in all patients preoperatively .
METHODS	In Group P , epidural analgesic solution was administered as a bolus before the surgical incision and was continued until the end of the surgery .
METHODS	Postoperative patient controlled epidural analgesia infusion pumps were prepared for all patients .
METHODS	Respiratory rates ( RR ) were recorded .
METHODS	Patient 's analgesia was evaluated with visual analog scale at rest ( VASr ) and coughing ( VASc ) .
METHODS	Number of patient 's demands from the pump , pump 's delivery , and additional analgesic requirement were also recorded .
RESULTS	RR in Group C was higher than in Group P at postoperative 1st and 2nd hours .
RESULTS	Both VASr and VASc scores in Group P were lower than in Group C at postoperative 1st , 2nd , and 4th hours .
RESULTS	Patient 's demand and pump 's delivery count for bolus dose in Group P were lower than in Group C in all measurement times .
RESULTS	Total analgesic requirements on postoperative 1st and 24th hours in Group P were lower than in Group C.
CONCLUSIONS	We consider that preemptive TEA may offer better analgesia after thoracotomy .

###24686106
BACKGROUND	and purpose Participant recruitment is central to all clinical trials .
BACKGROUND	Any delay in recruitment affects the completion and ultimate success of the trial .
BACKGROUND	We report our experience with patient screening and randomization in CombiRx , which may inform the design of other trials .
BACKGROUND	CombiRx was a multicenter , phase III , double-blind , randomized clinical trial comparing the combined use of interferon beta-1a and glatiramer acetate to either agent alone in patients with relapsing-remitting multiple sclerosis ( RRMS ) .
BACKGROUND	This trial was launched in January 2005 in 69 centers in the United States and Canada under a co-operative agreement with the National Institute of Neurological Disorders and Stroke ( NINDS ) .
BACKGROUND	The goal was to recruit 1000 patients over 1.5 years after a 6-month start-up period .
BACKGROUND	Instead , the investigators required 4.25 years to enroll 1008 patients .
METHODS	During this trial , we assessed the effectiveness of various recruitment strategies , utility of rescreening prior screen failures , and potential factors and strategies used in study conduct , research , and infrastructure , all of which affected recruitment of participants and ultimately time to completion of CombiRx .
METHODS	We particularly were interested in the variability in time to site initiation between academic centers and private practice sites .
RESULTS	Physicians who were directly involved in the medical care of patients with RRMS were the primary source of patients recruited to CombiRx .
RESULTS	A flexible study design that allowed for rescreening of the initial screen failures after a period of time was useful due to the relapsing/remitting course of the disease .
RESULTS	Academic centers took longer to implement the trial than the private practice centers , but once sites were approved for enrollment , there was no important difference in the number of participants enrolled .
CONCLUSIONS	The CombiRx trial was conducted during a period when multiple new medications were being tested , thus affecting the pace of recruitment and limiting ability to generalize our experiences .
CONCLUSIONS	However , the lessons we learned about process are relevant .
CONCLUSIONS	Participants can be enrolled successfully in a clinical trial for RRMS , but factors affecting the time to achieve the requirements needed to start screening can be unpredictable and problematic .
CONCLUSIONS	Prospective planning by the sponsors and investigators , use of central institutional review boards ( IRBs ) , master trial agreements and secure remote desktop access to the trial database may expedite trial implementation and participant recruitment .
CONCLUSIONS	A good scientific research question with flexible study design and active involvement of the clinicians are important factors driving recruitment .
CONCLUSIONS	Clinical trials can be implemented successfully both in private practices and at academic centers , a consideration when selecting sites .

###24359760
BACKGROUND	Primary health care in Tanzania is provided at two types of health units , the dispensary and the health centre .
BACKGROUND	Theoretically , primary health workers ( with knowledge of primary eye care [ PEC ] ) are ideally placed to identify people in need of eye care services .
BACKGROUND	In Tanzania , they are expected to be able to identify , treat , or correctly refer a number of eye conditions including cataract , trauma , presbyopia , and the ` red eye ' .
BACKGROUND	They are also expected to be able to measure visual acuity correctly and to educate the community about prevention .
OBJECTIVE	The objective was to determine the effect of enhanced supervision of health workers on PEC knowledge and skills in Kilimanjaro Region , Tanzania .
METHODS	This was a quasi-experimental , cluster randomized intervention study of an enhanced supervisory method compared to a routine supervisory method ; 36 dispensaries were randomly allocated into the two groups .
METHODS	Health workers based at government dispensaries in Mwanga District .
METHODS	Participants were interviewed pre and post intervention and the information was recorded using a standardized pretested questionnaire .
RESULTS	Mean scores of knowledge in healthcare workers was higher in the intervention group ( score = 6.43 , 80.4 % improvement ) compared to the non-intervention group ( score = 4.71 , 58.9 % improvement ) .
RESULTS	The ability to describe and demonstrate vision testing was better ( score = 1.8 ) in the enhanced supervision group compared to the routine supervision group ( score = 0.88 , P = 0.03 ) .
RESULTS	There was a high level of attrition ( 24 % ) within one year from the time of baseline survey , especially amongst clinical officers ( 44 % ) .
CONCLUSIONS	During the pilot study , enhanced supervision improved PEC knowledge and skills of health workers compared to health workers with routine supervision .
CONCLUSIONS	Training in PEC needs revision to become more practicum-based .
CONCLUSIONS	There is need to revise supervision guidelines ( to be skills-based ) and the supervision skills of district eye coordinators ( DECs ) need to be enhanced .
CONCLUSIONS	There is a huge need to improve governance ( accountability and rule of law ) of health staff .

###25620717
OBJECTIVE	To assess differences between manual wheelchairs and 3 pushrim-activated power-assisted wheelchairs ( PAPAWs ) : Servomatic A and B and E-motion .
METHODS	Repeated measures .
METHODS	Rehabilitation hospital .
METHODS	Volunteers with spinal cord injuries ( N = 52 ) .
METHODS	Ten subjects propelled the wheelchairs on a dynamometer , 46 evaluated each wheelchair on indoor and outdoor courses , and 10 evaluated their ability to transfer themselves and their wheelchairs into and out of their car .
METHODS	Oxygen consumption per unit time ( Vo2 ) and heart rate were measured during propulsion on the dynamometer .
METHODS	Wheelchair efficiency on the indoor and outdoor courses was evaluated on the basis of heart rate , completion time , handrim push frequency , and patient satisfaction .
RESULTS	On the dynamometer , decreases in Vo2 and heart rate were similar with the 3 PAPAWs compared with manual wheelchairs .
RESULTS	On the outdoor course , heart rate was significantly decreased by PAPAWs compared with manual wheelchairs and patient satisfaction was better with Servomatic devices than with the E-motion device .
RESULTS	Indoors , the course completion time was longer with the E-motion wheelchair than with other wheelchairs in the overall population , and handrim push frequency was higher with the E-motion wheelchair than with other wheelchairs in the subgroup with T12 to L1 injuries .
RESULTS	Car transfer ability was lower with PAPAWs than with manual wheelchairs .
CONCLUSIONS	Differences exist across PAPAWs .
CONCLUSIONS	Compared with E-motion , the 2 Servomatic PAPAWs were easier to use outdoors , and difficulty transferring into/out of the car was similarly increased with all 3 PAPAWs .

###24886581
BACKGROUND	Bipolar disorders ( BD ) are among the most severe mental disorders with first clinical signs and symptoms frequently appearing in adolescence and early adulthood .
BACKGROUND	The long latency in clinical diagnosis ( and subsequent adequate treatment ) adversely affects the course of disease , effectiveness of interventions and health-related quality of life , and increases the economic burden of BD .
BACKGROUND	Despite uncertainties about risk constellations and symptomatology in the early stages of potentially developing BD , many adolescents and young adults seek help , and most of them suffer substantially from symptoms already leading to impairments in psychosocial functioning in school , training , at work and in their social relationships .
BACKGROUND	We aimed to identify subjects at risk of developing BD and investigate the efficacy and safety of early specific cognitive-behavioural psychotherapy ( CBT ) in this subpopulation .
METHODS	EarlyCBT is a randomised controlled multi-centre clinical trial to evaluate the efficacy and safety of early specific CBT , including stress management and problem solving strategies , with elements of mindfulness-based therapy ( MBT ) versus unstructured group meetings for 14weeks each and follow-up until week 78 .
METHODS	Participants are recruited at seven university hospitals throughout Germany , which provide in - and outpatient care ( including early recognition centres ) for psychiatric patients .
METHODS	Subjects at high risk must be 15 to 30years old and meet the combination of specified affective symptomatology , reduction of psychosocial functioning , and family history for ( schizo ) affective disorders .
METHODS	Primary efficacy endpoints are differences in psychosocial functioning and defined affective symptomatology at 14weeks between groups .
METHODS	Secondary endpoints include the above mentioned endpoints at 7 , 24 , 52 and 78weeks and the change within groups compared to baseline ; perception of , reaction to and coping with stress ; and conversion to full BD .
CONCLUSIONS	To our knowledge , this is the first study to evaluate early specific CBT in subjects at high risk for BD .
CONCLUSIONS	Structured diagnostic interviews are used to map the risk status and development of disease .
CONCLUSIONS	With our study , the level of evidence for the treatment of those young patients will be significantly raised .
BACKGROUND	WHO International Clinical Trials Platform ( ICTRP ) , identifier : DRKS00000444 , date of registration : 16 June 2010 .

###24652308
OBJECTIVE	A primary goal of acute ischemic stroke ( AIS ) management is to maximize perfusion in the affected region and surrounding ischemic penumbra .
OBJECTIVE	However , interventions to maximize perfusion , such as flat head-of-bed ( HOB ) positioning , are currently prescribed empirically .
OBJECTIVE	Bedside monitoring of cerebral blood flow ( CBF ) allows the effects of interventions such as flat HOB to be monitored and may ultimately be used to guide clinical management .
METHODS	Cerebral perfusion was measured during HOB manipulations in 17 patients with unilateral AIS affecting large cortical territories in the anterior circulation .
METHODS	Simultaneous measurements of frontal CBF and arterial flow velocity were performed with diffuse correlation spectroscopy and transcranial Doppler ultrasound , respectively .
METHODS	Results were analyzed in the context of available clinical data and a previous study .
RESULTS	Frontal CBF , averaged over the patient cohort , decreased by 17 % ( P = 0.034 ) and 15 % ( P = 0.011 ) in the ipsilesional and contralesional hemispheres , respectively , when HOB was changed from flat to 30 .
RESULTS	Significant ( cohort-averaged ) changes in blood velocity were not observed .
RESULTS	Individually , varying responses to HOB manipulation were observed , including paradoxical increases in CBF with increasing HOB angle .
RESULTS	Clinical features , stroke volume , and distance to the optical probe could not explain this paradoxical response .
CONCLUSIONS	A lower HOB angle results in an increase in cortical CBF without a significant change in arterial flow velocity in AIS , but there is variability across patients in this response .
CONCLUSIONS	Bedside CBF monitoring with diffuse correlation spectroscopy provides a potential means to individualize interventions designed to optimize CBF in AIS .

###25377592
BACKGROUND	Trastuzumab ( Herceptin ( ) ) is a humanized monoclonal antibody targeting the human epidermal growth factor receptor 2 ( HER2 ) and is used in the treatment of HER2-overexpressing breast and gastric cancer .
BACKGROUND	FTMB is being developed as a biosimilar of trastuzumab .
OBJECTIVE	In this combined dose-escalation and bioequivalence study of parallel design , the pharmacokinetic profile of FTMB was compared with Herceptin ( ) .
METHODS	Healthy male volunteers received single doses of 0.5 , 1.5 , 3.0 or 6.0 mg/kg FTMB , or placebo , in consecutive dose-escalation cohorts to assess the safety profile .
METHODS	Thereafter , the 6 mg/kg cohort was expanded to establish bioequivalence between FTMB ( Test ) and Herceptin ( ) ( Reference ) based on an acceptance interval of 80.0-125 .0 % .
METHODS	In total , 118 subjects were enrolled in the study .
RESULTS	The mean area under the concentration-time curve from time zero to infinity ( AUC ) was 1,609 gday/mL ( Test ) and 1,330 gday/mL ( Reference ) .
RESULTS	The log-transformed geometric mean Test/Reference ( T/R ) ratio for AUC was 89.6 % ( 90 % confidence interval [ CI ] 85.1-94 .4 ) , demonstrating bioequivalence .
RESULTS	For the secondary endpoint , the maximum concentration observed ( Cmax ) , the geometric mean T/R ratio was 89.4 % ( 90 % CI 83.4-95 .9 ) .
RESULTS	Non-linear , target-mediated pharmacokinetics were also observed .
RESULTS	Adverse events other than the documented side effects of Herceptin ( ) ( fever , influenza-like illness , and fatigue ) did not occur .
RESULTS	No signs of cardiotoxicity were observed .
CONCLUSIONS	This bioequivalence study with a trastuzumab biosimilar in healthy male volunteers demonstrated bioequivalence of FTMB with Herceptin ( ) .
CONCLUSIONS	FTMB was well tolerated in doses up to 6 mg/kg .
CONCLUSIONS	Non-linear target elimination was also observed in the pharmacokinetic profile of trastuzumab .

###24331714
BACKGROUND	Nutritional insults and conditions during fetal life and infancy influence subsequent growth and body composition of children .
OBJECTIVE	Effects of maternal food and micronutrient supplementation and exclusive breastfeeding counseling on growth of offspring aged 0-54 months and their body composition at 54 months of age were studied .
METHODS	In the MINIMat trial ( ISRCTN16581394 ) in Matlab , Bangladesh , pregnant women were randomized to early ( around 9 weeks ) or usual invitation ( around 20 weeks ) to food supplementation and to one of the three daily micronutrient supplements : 30-mg Fe and 400-g folic acid ( Fe30F ) , 60-mg Fe and 400-g folic acid ( Fe60F ) , and multiple micronutrient supplements ( MMS ) .
METHODS	The supplements were also randomized to exclusive breastfeeding ( EBF ) counseling or to usual health messages .
RESULTS	No differences in background characteristics were observed among the intervention groups .
RESULTS	There was also no differential effect of prenatal interventions on birthweight or birthlength .
RESULTS	Early food supplementation reduced the level of stunting from early infancy up to 54 months of age among boys ( average difference - 6.5 % units , 95 % confidence interval [ CI ] 1.7-11 .3 , p = 0.01 ) but not among girls ( average difference - 2.4 % units , 95 % CI -2.2 -7.0 , p = 0.31 ) .
RESULTS	MMS resulted in more stunting compared to standard Fe60F ( average difference - 4.8 % units , 95 % CI 0.8-8 .9 , p = 0.02 ) .
RESULTS	Breastfeeding counseling prolonged the duration of EBF ( difference - 35 days , 95 % CI 30.6-39 .5 , p < 0.001 ) .
RESULTS	Neither pregnancy interventions nor breastfeeding counseling influenced the body composition of children at 54 months of age .
CONCLUSIONS	Early food supplementation during pregnancy reduced the occurrence of stunting among boys aged 0-54 months , while prenatal MMS increased the proportion of stunting .
CONCLUSIONS	Food and micronutrient supplementation or EBF intervention did not affect body composition of offspring at 54 months of age .
CONCLUSIONS	The effects of prenatal interventions on postnatal growth suggest programming effects in early fetal life .

###25339342
BACKGROUND	Limited evidence suggests that dietary interventions may offer a promising approach for migraine .
BACKGROUND	The purpose of this study was to determine the effects of a low-fat plant-based diet intervention on migraine severity and frequency .
METHODS	Forty-two adult migraine sufferers were recruited from the general community in Washington , DC , and divided randomly into two groups .
METHODS	This 36-week crossover study included two treatments : dietary instruction and placebo supplement .
METHODS	Each treatment period was 16 weeks , with a 4-week washout between .
METHODS	During the diet period , a low-fat vegan diet was prescribed for 4 weeks , after which an elimination diet was used .
METHODS	Participants were assessed at the beginning , midpoint , and end of each period .
METHODS	Significance was determined using student 's t-tests .
RESULTS	Worst headache pain in last 2 weeks , as measured by visual analog scale , was initially 6.4 / 10 cm ( SD 2.1 cm ) , and declined 2.1 cm during the diet period and 0.7 cm during the supplement period ( p = 0.03 ) .
RESULTS	Average headache intensity ( 0-10 scale ) was initially 4.2 ( SD 1.4 ) per week , and this declined by 1.0 during the diet period and by 0.5 during the supplement period ( p = 0.20 ) .
RESULTS	Average headache frequency was initially 2.3 ( SD 1.8 ) per week , and this declined by 0.3 during the diet period and by 0.4 during the supplement period ( p = 0.61 ) .
RESULTS	The Patient 's Global Impression of Change showed greater improvement in pain during the diet period ( p < 0.001 ) .
CONCLUSIONS	These results suggest that a nutritional approach may be a useful part of migraine treatment , but that methodologic issues necessitate further research .
BACKGROUND	Clinicaltrials.gov , NCT01699009 and NCT01547494 .

###25197999
OBJECTIVE	The purpose of this study was to determine if educating parents with visual aids after their child 's treatment under general anesthesia would improve attendance at follow-up appointments , oral health outcomes , and treatment satisfaction .
METHODS	Fifty-four parent-child dyads were recruited and randomly assigned to two groups .
METHODS	The control group received verbal education , and the intervention group received verbal and visual education .
METHODS	Oral health was measured using the Gingival Index and the Simplified Oral Hygiene Index ( OHI-S ) before and after the treatment .
METHODS	Parent surveys were administered before and after treatment .
METHODS	MResults : Seventy-eight percent of the intervention group and 52 percent of the control group returned for follow-up appointments ( P = .04 ) .
METHODS	The plaque index decreased ( P < .01 ) ; the reported brushing frequency increased for all children from baseline to follow-up visit ( P = .02 ) .
METHODS	The satisfaction increased only for parents in the intervention group over time ( P = .04 ) .
CONCLUSIONS	Using visual aids had a positive impact on patient attendance at follow-up and parents ' treatment satisfaction .
CONCLUSIONS	There was an improvement in oral hygiene , as measured by the OHI-S , and an increase in brushing frequency for all children , regardless of whether their parents were educated with or without a visual aid .

###25299832
OBJECTIVE	To evaluate the association between adolescent and young-adult hearing loss and nonverbal intelligence in rural Nepal .
METHODS	Cross-sectional assessment of hearing loss among a population cohort of adolescents and young adults .
METHODS	Sarlahi District , southern Nepal .
METHODS	Seven hundred sixty-four individuals aged 14 to 23 years .
METHODS	Evaluation of hearing loss , defined by World Health Organization criteria of pure-tone average greater than 25 decibels ( 0.5 , 1 , 2 , 4 kHz ) , unilaterally and bilaterally .
METHODS	Nonverbal intelligence , as measured by the Test of Nonverbal Intelligence , 3rd Edition standardized score ( mean , 100 ; standard deviation , 15 ) .
RESULTS	Nonverbal intelligence scores differed between participants with normal hearing and those with bilateral ( p = 0.04 ) but not unilateral ( p = 0.74 ) hearing loss .
RESULTS	Demographic and socioeconomic factors including male sex ; higher caste ; literacy ; education level ; occupation reported as student ; and ownership of a bicycle , watch , and latrine were strongly associated with higher nonverbal intelligence scores ( all p < 0.001 ) .
RESULTS	Subjects with bilateral hearing loss scored an average of 3.16 points lower ( 95 % confidence interval , -5.56 to -0.75 ; p = 0.01 ) than subjects with normal hearing after controlling for socioeconomic factors .
RESULTS	There was no difference in nonverbal intelligence score based on unilateral hearing loss ( 0.97 ; 95 % confidence interval , -1.67 to 3.61 ; p = 0.47 ) .
CONCLUSIONS	Nonverbal intelligence is adversely affected by bilateral hearing loss even at mild hearing loss levels .
CONCLUSIONS	Socio economic well-being appears compromised in individuals with lower nonverbal intelligence test scores .

###24289736
BACKGROUND	Cardiovascular complications are the leading cause of mortality and morbidity in Marfan syndrome ( MFS ) , a dominantly inherited disorder caused by mutations in the gene that encodes fibrillin-1 .
BACKGROUND	There are approximately 18,000 patients in the UK with MFS .
BACKGROUND	Current treatment includes careful follow-up , beta blockers , and prophylactic surgical intervention ; however , there is no known treatment which effectively prevents the rate of aortic dilatation in MFS .
BACKGROUND	Preclinical , neonatal , and pediatric studies have indicated that angiotensin receptor blockers ( ARBs ) may reduce the rate of aortic dilatation .
BACKGROUND	This trial will investigate the effects of irbesartan on aortic dilatation in Marfan syndrome .
METHODS	The Aortic Irbesartan Marfan Study ( AIMS ) is an investigator-led , prospective , randomized , placebo-controlled , double-blind , phase III , multicenter trial .
METHODS	Currently , 26 centers in the UK will recruit 490 clinically confirmed MFS patients ( aged 6 to 40 years ) using the revised Ghent diagnostic criteria .
METHODS	Patients will be randomized to irbesartan or placebo .
METHODS	Aortic root dilatation will be measured by transthoracic echocardiography at baseline and annually thereafter .
METHODS	The primary outcome is the absolute change in aortic root diameter per year measured by echocardiography .
METHODS	The follow-up period will be a minimum of 36 months with an expected mean follow-up period of 48 months .
CONCLUSIONS	This is the first clinical trial to evaluate the ARB irbesartan versus placebo in reducing the rate of aortic root dilatation in MFS .
CONCLUSIONS	Not only will this provide useful information on the safety and efficacy of ARBs in MFS , it will also provide a rationale basis for potentially lifesaving therapy for MFS patients .
BACKGROUND	ISRCTN , 90011794 .

###25071367
BACKGROUND	Asteatotic eczema ( AE ) is characterized by itchy , dry , rough , and scaling skin .
BACKGROUND	The treatments for AE are mainly emollients , usually containing urea , lactic acid , or a lactate salt .
BACKGROUND	N-palmitoylethanolamine ( PEA ) and N-acetylethanolamine ( AEA ) are both endogenous lipids used as novel therapeutic tools in the treatment of many skin diseases .
BACKGROUND	The purpose of this study was to compare a PEA/AEA emollient with a traditional emollient in the treatment of AE .
METHODS	A monocentric , randomized , double-blind , comparative trial was conducted in 60 AE patients to evaluate and compare the efficacy of the two emollients .
METHODS	The level of skin dryness among the subjects ranged from mild to moderate .
METHODS	The subjects ' skin barrier function and the current perception threshold were tested for 28 days by clinical scoring and bioengineering technology .
RESULTS	The results showed that , although some aspects were improved in both groups , the group using the emollient containing PEA/AEA presented a better skin surface change in capacitance .
RESULTS	However , the most impressive finding was the ability of the PEA/AEA emollient to increase the 5 Hz current perception threshold to a normal level after 7 days , with a significant difference between values at baseline and after 14 days .
RESULTS	A current perception threshold of 5 Hz was positively and significantly correlated with skin surface hydration and negatively correlated with transepidermal water loss in the PEA/AEA emollient group .
CONCLUSIONS	Compared with traditional emollients , regular application of a topical PEA/AEA emollient could improve both passive and active skin functions simultaneously .

###24533510
OBJECTIVE	To compare health outcomes during 14-year observational follow-up in women initially randomised to unopposed estrogen or placebo .
METHODS	At recruitment to the Estrogen for the Prevention of Re-Infarction Trial ( ESPRIT ) women were assigned to estradiol valerate : 2mg or placebo treatment for 2years .
METHODS	Women were recruited from 35 hospitals in the northwest of England and Wales in July 1996-February 2000 .
METHODS	Women aged 50-69 surviving their first myocardial infarction .
METHODS	All women were followed by data linkage to UK mortality and cancer records ; mean follow-up 14.1 and 12.6 years , respectively .
METHODS	In an intention-to-treat analysis , hazard ratios ( HRs ) were computed , overall and stratified by age at recruitment .
METHODS	Death ( all-cause , cardiac disease , stroke or cancer ) and cancer incidence ( any , breast or endometrium ) .
RESULTS	There were 418 deaths in 1017 women randomised .
RESULTS	The all-cause mortality HR of 1.07 ( 95 % CI 0.88-1 .29 ) indicated no significant difference between treatment groups .
RESULTS	Women aged 50-59years at recruitment had lower HRs than women aged 60-69years for all outcomes except ischaemic heart disease .
RESULTS	Among 149 incident cancers there were seven cases of breast cancer in the intervention arm and 15 in the placebo ; HR 0.47 ( 95 % CI 0.19-1 .15 ) .
RESULTS	There were no deaths from endometrial cancer but three incident cases , one in the active arm and two in placebo .
CONCLUSIONS	These results suggest that unopposed estrogen may be used safely by women with an intact uterus surviving a first myocardial infarction .

###26076964
BACKGROUND	CHA2DS2-VASc and CHADS2 scores were derived and validated for stroke-risk stratification in patients who have a diagnosis of atrial fibrillation ( AF ) .
BACKGROUND	We hypothesized that these scores would predict adverse cardiovascular events even in the absence of AF .
METHODS	The CHA2DS2-VASc and CHADS2 scores for 2010 patients with sick sinus syndrome who underwent pacemaker implantation and were enrolled in the Mode Selection Trial ( MOST ) were calculated .
METHODS	The association of these risk scores with main trial end points , including the composite of death and stroke , were evaluated to determine whether the associations differed by history of AF .
RESULTS	Of the 2010 patients , 12 % had a CHA2DS2-VASc score of 0-1 , 16 % had a score of 2 , 41 % had a score of 3-4 , and 31 % had a score 5 ( the distribution for CHADS2 was similar ) ; 42 % had a clinical history of AF .
RESULTS	Both scores were associated with death or stroke ( hazard ratio [ HR ] , 1.14 ; 95 % confidence interval [ CI ] , 1.05-1 .23 for each 1-point increase in CHA2DS2-VASc ; P = 0.001 ; HR , 1.11 ; 95 % CI , 1.02-1 .21 for each 1-point increase in CHADS2 ; P = 0.016 ) .
RESULTS	Association of scores with outcomes of death , stroke , and heart failure hospitalization were not different for patients with vs those without a history of AF ( interaction P 0.55 for CHA2DS2-VASc and 0.30 for CHADS2 ) .
CONCLUSIONS	Both CHA2DS2-VASc and CHADS2 scores predict risk of death or stroke in patients with sick sinus syndrome , regardless of AF history .
CONCLUSIONS	These scores could be risk-stratification tools for clinical events that might respond to new therapiesie , anticoagulation or other interventionseven in the absence of AF .

###24886787
OBJECTIVE	Most acute kidney injury observed in the hospital is defined by sudden mild or moderate increases in the serum creatinine concentration , which may persist for several days .
OBJECTIVE	Such acute kidney injury is associated with lower long-term kidney function .
OBJECTIVE	However , it has not been demonstrated that an intervention that reduces the risk of such acute kidney injury better preserves long-term kidney function .
OBJECTIVE	To characterize the risk of acute kidney injury with an intervention in a randomized clinical trial and to determine if there is a difference between the 2 treatment groups in kidney function 1 year later .
METHODS	The Coronary Artery Bypass Grafting Surgery Off - or On-pump Revascularisation Study ( CORONARY ) enrolled 4752 patients undergoing first isolated coronary artery bypass graft ( CABG ) surgery at 79 sites in 19 countries .
METHODS	Patients were randomized to receive CABG surgery either with a beating-heart technique ( off-pump ) or with cardiopulmonary bypass ( on-pump ) .
METHODS	From January 2010 to November 2011 , 2932 patients ( from 63 sites in 16 countries ) from CORONARY were enrolled into a kidney function substudy to record serum creatinine concentrations during the postoperative period and at 1 year .
METHODS	The last 1-year serum creatinine concentration was recorded on January 18 , 2013 .
METHODS	Acute kidney injury within 30 days of surgery ( 50 % increase in serum creatinine concentration from prerandomization concentration ) and loss of kidney function at 1 year ( 20 % loss in estimated glomerular filtration rate from prerandomization level ) .
RESULTS	Off-pump ( n = 1472 ) vs on-pump ( n = 1460 ) CABG surgery reduced the risk of acute kidney injury ( 17.5 % vs 20.8 % , respectively ; relative risk , 0.83 [ 95 % CI , 0.72-0 .97 ] , P = .01 ) ; however , there was no significant difference between the 2 groups in the loss of kidney function at 1 year ( 17.1 % vs 15.3 % , respectively ; relative risk , 1.10 [ 95 % CI , 0.95-1 .29 ] , P = .23 ) .
RESULTS	Results were consistent with multiple alternate continuous and categorical definitions of acute kidney injury or kidney function loss , and in the subgroup with baseline chronic kidney disease .
CONCLUSIONS	Use of off-pump compared with on-pump CABG surgery reduced the risk of postoperative acute kidney injury , without evidence of better preserved kidney function with off-pump CABG surgery at 1 year .
CONCLUSIONS	In this setting , an intervention that reduced the risk of mild to moderate acute kidney injury did not alter longer-term kidney function .
BACKGROUND	clinicaltrials.gov Identifier : NCT00463294 .

###25822572
OBJECTIVE	Osteoarthritis ( OA ) of the knee is the most frequent form of arthritis and a cause of pain and disability .
OBJECTIVE	Combined nonpharmacologic and pharmacologic treatments are recommended as the optimal treatment approach , but no evidence supports the recommendation .
OBJECTIVE	To assess the clinical benefits of an intra-articular corticosteroid injection given before exercise therapy in patients with OA of the knee .
METHODS	We performed a randomized , blinded , placebo-controlled clinical trial evaluating the benefit of intra-articular corticosteroid injection vs placebo injection given before exercise therapy at an OA outpatient clinic from October 1 , 2012 , through April 2 , 2014 .
METHODS	The participants had radiographic confirmation of clinical OA of the knee , clinical signs of localized inflammation in the knee , and knee pain during walking ( score > 4 on a scale of 0 to 10 ) .
METHODS	Participants were randomly allocated ( 1:1 ) to an intra-articular 1-mL injection of the knee with methylprednisolone acetate ( Depo-Medrol ) , 40 mg/mL , dissolved in 4 mL of lidocaine hydrochloride ( 10 mg/mL ) ( corticosteroid group ) or a 1-mL isotonic saline injection mixed with 4 mL of lidocaine hydrochloride ( 10 mg/mL ) ( placebo group ) .
METHODS	Two weeks after the injections , all participants started a 12-week supervised exercise program .
METHODS	The primary outcome was change in the Pain subscale of the Knee Injury and Osteoarthritis Outcome Score ( KOOS ) questionnaire ( range , 0-100 ; higher scores indicate greater improvement ) at week 14 .
METHODS	Secondary outcomes included the remaining KOOS subscales and objective measures of physical function and inflammation .
METHODS	Outcomes were measured at baseline , week 2 ( exercise start ) , week 14 ( exercise stop ) , and week 26 ( follow-up ) .
RESULTS	One hundred patients were randomized to the corticosteroid group ( n = 50 ) or the placebo group ( n = 50 ) ; 45 and 44 patients , respectively , completed the trial .
RESULTS	The mean ( SE ) changes in the KOOS Pain subscale score at week 14 were 13.6 ( 1.8 ) and 14.8 ( 1.8 ) points in the corticosteroid and placebo groups , respectively , corresponding to a statistically insignificant mean difference of 1.2 points ( 95 % CI , -3.8 to 6.2 ; P = .64 ) .
RESULTS	We found no statistically significant group differences in any of the secondary outcomes at any time point .
CONCLUSIONS	No additional benefit results from adding an intra-articular injection of 40 mg of corticosteroid before exercise in patients with painful OA of the knee .
CONCLUSIONS	Further research is needed to establish optimal and potentially synergistic combinations of conservative treatments .
BACKGROUND	clinicaltrialsregister.eu Identifier : 2012-002607-18 ; clinicaltrials.gov Identifier : NCT01945749 .

###25590472
OBJECTIVE	To assess whether a suture technique in upper blepharoplasty may be the cause of differences in the occurrence of suture abscess formation and focal inflammation .
METHODS	A Level I , randomized controlled trial .
METHODS	The upper blepharoplasty wound was closed with a running intradermal suture .
METHODS	External intradermal suturing implied that this suture was started by initially passing it through the intact skin adjacent to the wound .
METHODS	In contrast , internal intradermal suturing meant the intradermal suture was not started in the adjacent skin but simply within the wound itself .
METHODS	One week and 6 weeks after surgery , the presence of suture abscesses and focal inflammation was assessed at the entrance and exit of the sutures .
RESULTS	After 1 week , 12 abscesses ( 40.0 % ) were found at the medial side of the externally sutured upper eyelids and 4 abscesses ( 13.3 % ) in the internally sutured upper eyelids ( p = .02 ) .
RESULTS	The presence of erythema and edema after 1 week was also significantly lower in internally sutured upper eyelids ( p = .02 ) .
CONCLUSIONS	In this series , the method of starting the suture ( internal vs external ) at the medial side of an upper blepharoplasty wound was associated with a statistically significant reduction in the incidence of medial wound inflammation and suture abscess formation at a 1-week follow-up .

###24334578
OBJECTIVE	Adverse skin reactions as a local side effect of nicotine patches sometimes interfere with smoking cessation therapy .
OBJECTIVE	We studied the effects of semipermeable membrane dressings ( SMD ) used under nicotine patches ( NP ) on nicotine absorption , as assessed according to the urinary cotinine levels , and skin symptoms .
METHODS	First , the urinary cotinine levels were compared in eight nonsmokers that applied NP over SMD and NP without SMD ( Study 1 ) .
METHODS	The urinary cotinine levels were measured using a highly sensitive competitive enzyme immunoassay .
METHODS	Second , 28 subjects undergoing NP therapy for diagnosed nicotine dependence were randomly assigned into two groups in a crossover design to receive NP over SMD and NP without SMD .
METHODS	The urinary cotinine levels and skin symptoms were compared between the two treatment groups .
METHODS	During the follow-up period of 48 weeks , the smoking cessation rate was evaluated ( Study 2 ) .
RESULTS	No statistical differences were observed in the urinary cotinine levels between the NP over SMD and NP without SMD groups .
RESULTS	In Study 2 , the skin symptoms improved with the use of SMD in 42.8 % ( 6/14 ) of the patients and worsened in 28.5 % ( 4/14 ) of the patients .
RESULTS	No serious skin disorders were reported .
RESULTS	The subjects followed in Study 2 exhibited smoking cessation rates of 92.8 % , 78.5 % and 64.2 % at 12 , 24 and 48 weeks , respectively .
CONCLUSIONS	The use of NP over SMD is a safe and effective alternative application to NP treatment for preventing the skin symptoms caused by NP without interfering with nicotine absorption .

###24930546
BACKGROUND	Metal-on-metal ( MOM ) total hip arthroplasties were reintroduced because of the problems with osteolysis and aseptic loosening related to polyethylene wear of early metal-on-polyethylene ( MOP ) arthroplasties .
BACKGROUND	The volumetric wear rate has been greatly reduced with MOM arthroplasties ; however , because of nano-size wear particles , the absolute number has been greatly increased .
BACKGROUND	Thus , a source of metal ion exposure with the potential to sensitize patients is present .
BACKGROUND	We hypothesized that higher amounts of wear particles result in increased release of metal ions and ultimately lead to an increased incidence of metal allergy .
METHODS	52 hips in 52 patients ( median age 60 ( 51-64 ) years , 30 women ) were randomized to either a MOM hip resurfacing system ( ReCap ) or a standard MOP total hip arthoplasty ( Mallory Head/Exeter ) .
METHODS	Spot urine samples were collected preoperatively , postoperatively , after 3 months , and after 1 , 2 , and 5 years and tested with inductively coupled plasma-sector field mass spectrometry .
METHODS	After 5 years , hypersensitivity to metals was evaluated by patch testing and lymphocyte transformation assay .
METHODS	In addition , the patients answered a questionnaire about hypersensitivity .
RESULTS	A statistically significant 10 - to 20-fold increase in urinary levels of cobalt and chromium was observed throughout the entire follow-up in the MOM group .
RESULTS	The prevalence of metal allergy was similar between groups .
CONCLUSIONS	While we observed significantly increased levels of metal ions in the urine during the entire follow-up period , no difference in prevalence of metal allergy was observed in the MOM group .
CONCLUSIONS	However , the effect of long-term metal exposure remains uncertain .

###25034738
OBJECTIVE	To investigate the effect of pancreatic duct stent internal versus external drainage with pancreaticojejunostomy on the early curative effect after pancreaticoduodenectomy ( PD ) .
METHODS	The study was a prospective controlled trial .
METHODS	A total of 219 patients undergoing PD from January 2010 to March 2013 were randomly divided into external drainage group ( n = 110 ) and internal drainage group ( n = 109 ) .
METHODS	The pancreatic duct stent was put in the jejunum during the operation in the internal drainage group , while that in the external drainage group was placed outside the body through the jejunum and abdominal wall .
METHODS	The intra-operative blood loss , operative duration , post-operative hospital stay , mortality rate , and the morbidity of pancreatic fistula as well as other complications were compared between the two groups .
RESULTS	Compared with internal drainage group , pancreatic duct stent external drainage obviously reduced the morbidity of pancreatic fistula ( 13.6 % vs. 22.6 % ) , delayed gastric emptying ( 10.0 % vs. 27.5 % ) , abdominal infection ( 6.4 % vs. 19.3 % ) , intestinal obstruction ( 8.2 % vs. 20.2 % ) along with the overall complications ( 24.5 % vs. 41.3 % ) after PD ( ( 2 ) = 5.735 8 to 11.047 7 , P < 0.05 ) , and shortened the healing duration of pancreatic fistula ( ( 11.5 2.9 ) d vs. ( 20.1 5.7 ) d , t = 5.07 , P < 0.01 ) , while there was no significant difference in the intra-operative blood loss , operative duration , post-operative hospital stay and mortality rate , etc between the two groups ( P > 0.05 ) .
CONCLUSIONS	Pancreatic duct stent external drainage can effectively reduce the morbidity of pancreatic fistula and the overall complications after PD , which is safe and feasible .
CONCLUSIONS	The method is worthy of popularization and application clinically .

###24488080
OBJECTIVE	Serum sclerostin levels have been reported to be inversely associated with serum 25OHD levels , but the effect of vitamin D and calcium supplementation on serum sclerostin levels is unknown .
OBJECTIVE	This study was carried out to determine whether vitamin D and calcium supplementation altered serum sclerostin levels in healthy older adults .
METHODS	We measured serum sclerostin levels at baseline and after 2 years in 279 men and women who participated in a placebo-controlled vitamin D ( 700IU/day ) and calcium ( 500mg/day ) intervention trial carried out in men and women aged 65 years .
METHODS	Serum sclerostin levels were measured using the MesoScale Discovery chemiluminescence assay .
RESULTS	In the men , sclerostin levels increased over 2 years by 4.111.81 ng/l ( 13.1 % ) in the vitamin D plus calcium-supplemented group and decreased by 3.161.78 ng/l ( 10.9 % ) in the placebo group ( P = 0.005 for difference in change ) .
RESULTS	Adjustments for the season of measurement , baseline physical activity levels , baseline serum sclerostin levels , and total body bone mineral content did not substantially alter the changes .
RESULTS	In the women , there was no significant group difference in change in serum sclerostin levels either before or after the above-mentioned adjustments .
RESULTS	In both the sexes , vitamin D and calcium supplementation significantly increased serum ionized calcium levels and decreased parathyroid hormone levels .
CONCLUSIONS	Men and women appear to have different serum sclerostin responses to vitamin D and calcium supplementation .
CONCLUSIONS	The reason for this difference remains to be determined .

###25552940
OBJECTIVE	The research tested the accuracy of the VIVO Harvester software in identifying publications authored by faculty members affiliated with a National Institutes of Health Clinical and Translational Sciences Award ( CTSA ) site .
METHODS	Health sciences librarians created `` gold standard '' lists of references for the years 2001 to 2011 from PubMed for twenty-five randomly selected investigators from one CTSA site .
METHODS	These gold standard lists were compared to the same twenty-five investigators ' reference lists produced by VIVO Harvester .
METHODS	The authors subjected the discrepancies between the lists to sensitivity and specificity analyses .
RESULTS	The VIVO Harvester correctly identified only about 65 % of the total eligible PubMed references for the years 2001-2011 for the CTSA-affiliated investigators .
RESULTS	The identified references produced by VIVO Harvester were precise yet incomplete .
RESULTS	The sensitivity rate was 0.65 , and the specificity rate was 1.00 .
CONCLUSIONS	While the references produced by VIVO Harvester could be confirmed in PubMed , the VIVO Harvester retrieved only two-thirds of the required references from PubMed .
CONCLUSIONS	National Institutes of Health CTSA sites will need to supplement VIVO Harvester-produced references with the expert searching skills of health sciences librarians .
CONCLUSIONS	Health sciences librarians with searching skills need to alert their CTSA sites about these deficiencies and offer their skills to advance their sites ' missions .

###24838177
OBJECTIVE	The aim was to evaluate the effect of boceprevir and telaprevir on dolutegravir pharmacokinetics ( PK ) ; the effect of dolutegravir on boceprevir and telaprevir PK was assessed through comparison with historical data for each hepatitisC virus ( HCV ) drug 's prescribing information alone .
METHODS	This was a single-centre , randomized , open-label , two-cohort , two-period , one-way study in healthy adult subjects .
METHODS	Dolutegravir 50mg once daily was administered for 5 days in Period1 , and dolutegravir 50mg once daily was coadministered with either boceprevir 800mg every 8h ( Cohort1 ) or telaprevir 750mg every 8h ( Cohort2 ) for 10days in Period2 .
RESULTS	No deaths or serious adverse events were reported during the study .
RESULTS	Four subjects were withdrawn from the study because of adverse events ( elevated alanine aminotransferase , cellulitis , increased serum creatinine and dizziness ) .
RESULTS	One subject became pregnant during the study .
RESULTS	Coadministration of dolutegravir with boceprevir had no effect on dolutegravir area under the plasma concentration-time curve ( AUC ) and maximal plasma concentration ( Cmax ) and caused a small increase in concentration at the end of the dosing interval ( C ; 8 % ) .
RESULTS	Coadministration of dolutegravir with telaprevir resulted in increased dolutegravir plasma exposures compared with those after administration of dolutegravir alone ; AUC0 - , Cmax and C increased by 25 , 19 and 37 % , respectively .
RESULTS	Coadministration of boceprevir or telaprevir with dolutegravir had no clinically significant effect on dolutegravir PK .
RESULTS	Plasma boceprevir and telaprevir PK data for either combined treatment were similar to historical data , indicating no effect of dolutegravir on boceprevir or telaprevir exposure .
CONCLUSIONS	Dolutegravir can be coadministered with boceprevir or telaprevir in patients coinfected with HIV and HCV with no dose adjustment .

###25393590
BACKGROUND	The blood/gas partition coefficient of a certain volatile anesthetic is of clinical importance because it determines its velocity of uptake into and elimination from the body of a patient and thus its pharmacokinetic behavior .
BACKGROUND	To date , the blood/gas partition coefficients of isoflurane , sevoflurane , and desflurane have been measured in small numbers of subjects or in particular study groups , for example , healthy volunteers , patients experiencing a common kind of disease , or mothers immediately after giving birth .
BACKGROUND	The objective of this study was to determine the blood/gas partition coefficients of these volatile anesthetics at 37C in a larger clinically relevant and adult patient population .
BACKGROUND	Furthermore , we tested whether age , gender , body mass index , hemoglobin concentration , or hematocrit had an influence on the coefficients .
METHODS	Blood samples were taken from 120 fasting operative patients with ASA physical status I to III and aged 19 to 86 years .
METHODS	All subjects were randomly enrolled in study groups for the separate determinations of the blood/gas partition coefficients of isoflurane ( n = 41 ) , sevoflurane ( n = 41 ) , and desflurane ( n = 38 ) by headspace gas chromatography .
METHODS	To check the quality of the measurements , we determined the distilled water/gas partition coefficients of those anesthetics and compared them with previously published values .
RESULTS	We found a blood/gas partition coefficient of 1.45 0.12 ( mean SD ) for isoflurane , 0.74 0.06 for sevoflurane , and 0.57 0.04 for desflurane .
RESULTS	Values of this study are 5.07 % , 12.12 % , and 7.55 % higher for isoflurane , sevoflurane , and desflurane , respectively , than the previously published mean values ( all P 0.001 ) .
RESULTS	There were only trends for small correlations between the blood/gas partition coefficient of isoflurane and hemoglobin concentration ( Pearson r = 0.32 ; P = 0.041 ) and hematocrit ( r = 0.37 ; P = 0.016 ) .
RESULTS	We found no other potentially significant correlations of the partition coefficients with patient age , body mass index , hemoglobin concentration , or hematocrit ( all remaining P > 0.069 ) .
RESULTS	Furthermore , the coefficients did not differ significantly between female and male patients .
RESULTS	The evaluation of the distilled water/gas partition coefficients of isoflurane ( 0.59 0.04 ) , sevoflurane ( 0.37 0.04 ) , and desflurane ( 0.27 0.03 ) proved the validity of the gas chromatography method used in this study .
CONCLUSIONS	The blood/gas partition coefficients of the modern volatile anesthetics , in particular , those of sevoflurane and desflurane , may be higher than that has been hitherto reported .
CONCLUSIONS	Therefore , their uptake and elimination may occur more slowly in some patients than has been supposed .
CONCLUSIONS	The blood/gas partition coefficients of isoflurane , sevoflurane , and desflurane measured in this study appear to be representative because they were determined in a clinically and numerically relevant patient cohort .

###24559210
OBJECTIVE	Physical activity is a key factor for healthy ageing , yet many older people lead a sedentary lifestyle .
OBJECTIVE	Traditional physical activity interventions do not consider the specific needs and views of older adults .
OBJECTIVE	As views on ageing are known to be related to health behaviours , the current study evaluates the effectiveness of prompting positive views on ageing within a physical activity intervention .
METHODS	Randomised controlled trial with three groups aged 65 + : Intervention for physical activity with ` views-on-ageing ' - component ( n = 101 ; IGVoA ) , and without ` views-on-ageing ' - component ( n = 30 ; IG ) , and active control intervention for volunteering ( n = 103 ; CG ) .
METHODS	Attitudes towards older adults and physical activity were assessed five weeks before intervention , two weeks , six weeks and 8.5 months after the intervention .
RESULTS	Compared to the IG and CG , positive attitudes towards older adults increased in the IGVoA after the intervention .
RESULTS	For IGVoA , the indirect intervention effect on change in activity via change in attitudes towards older adults was reliable .
CONCLUSIONS	A ` views-on-ageing ' - component within a physical activity intervention affects change in physical activity via change in views on ageing .
CONCLUSIONS	Views on ageing are a promising intervention technique to be incorporated into future physical activity interventions for older adults .

###25447334
OBJECTIVE	Evaluate a selective obesity prevention program promoting use of cognitive reappraisals to reduce reward region response and increase inhibitory region response to high-fat/high-sugar foods and reduce intake of fat and sugar to prevent blunted reward region response to intake of such foods .
METHODS	Young adults at risk for future weight gain by virtue of weight concerns ( N = 148 ) were randomized to this new prevention program ( Minding Health ) , an alternative prevention program promoting participant-driven gradual reductions in caloric intake and increases in physical activity ( Healthy Weight ) , or an obesity education video control condition , completing assessments at pre - , post - , and 6-month follow-up .
METHODS	A subset of Minding Health and control participants completed an fMRI scan at pre - and post-assessing neural response to images of high-fat/sugar foods and to receipt and anticipated receipt of a high-fat/sugar food .
RESULTS	Minding Health participants showed significantly greater reductions in body fat than controls and caloric intake from fat and sugar than Healthy Weight participants .
RESULTS	Minding Health participants also showed greater activation of an inhibitory control region and reduced activation of an attention/expectation region in response to palatable food images relative to pretest and controls .
RESULTS	However , Healthy Weight participants showed greater reductions in BMI and eating disorder symptoms than Minding Health participants .
CONCLUSIONS	Although the Minding Health intervention produced some of the hypothesized effects , it did not produce lasting reductions in body fat or BMI and showed limited effects on neural responsivity , implying it will be vital to increase the efficacy of this new prevention program .

###26135078
BACKGROUND	Sixty-two percent of patients would like their doctor to recommend a specific web site to find health information , but only 3 % of patients receive such recommendations .
BACKGROUND	We investigated whether providing patients with an Internet web-site link recommended by their physician would improve patient knowledge and satisfaction .
BACKGROUND	Our hypothesis was that directing patients to a reliable web site would improve both .
METHODS	Sixty patients with a new diagnosis of carpal tunnel syndrome were prospectively randomized into two groups .
METHODS	Twenty-three patients in the control group had a traditional physician office visit and received standard care for carpal tunnel syndrome .
METHODS	Thirty-seven patients in the treatment group received a handout that directed them to the American Society for Surgery of the Hand ( ASSH ) web page on carpal tunnel syndrome in addition to the standard care provided in the office visit .
METHODS	Patients later completed a ten-question true-or-false knowledge questionnaire and a six-item satisfaction survey .
METHODS	Differences in scores were analyzed using two-sample t tests .
RESULTS	Less than half ( 48 % ) of the patients who were given the Internet directive reported that they had visited the recommended web site .
RESULTS	The mean scores on the knowledge assessment ( 6.84 of 10 for the treatment group and 6.96 of 10 for the control group ) and the satisfaction survey ( 4.49 of 5 for the treatment group and 4.43 of 5 for the control group ) were similar for both groups .
RESULTS	The mean score for knowledge was similar for the patients who had used the ASSH web site and for those who had not ( 6.89 and 6.97 respectively ) .
RESULTS	Moreover , compared with patients who had not used the Internet at all to learn about carpal tunnel syndrome , patients who used the Internet scored 6.6 % better ( mean score , 7.14 for those who used the Internet compared with 6.70 for those who had not ; p > 0.05 ) .
RESULTS	Regardless of Internet usage , most patients scored well on the knowledge assessment and reported a high level of satisfaction .
CONCLUSIONS	Whether the patient was given a handout or had visited the ASSH or other Internet web sites , the knowledge and satisfaction scores for all patients were similar .
CONCLUSIONS	Since the physician was the common denominator in both groups , the results indicate that the patient-physician relationship may be more valuable than the Internet in providing patient education .
CONCLUSIONS	Effective communication between patients and practitioners is at the cornerstone of delivering excellent care and building trusting relationships .
CONCLUSIONS	This study examines whether reliable Internet information should be embraced as a tool to enhance patient-surgeon communication in a clinical context .

###24461664
BACKGROUND	Indigenous children in high-income countries have a heavy burden of bronchiectasis unrelated to cystic fibrosis .
BACKGROUND	We aimed to establish whether long-term azithromycin reduced pulmonary exacerbations in Indigenous children with non-cystic-fibrosis bronchiectasis or chronic suppurative lung disease .
METHODS	Between Nov 12 , 2008 , and Dec 23 , 2010 , we enrolled Indigenous Australian , Maori , and Pacific Island children aged 1-8 years with either bronchiectasis or chronic suppurative lung disease into a multicentre , double-blind , randomised , parallel-group , placebo-controlled trial .
METHODS	Eligible children had had at least one pulmonary exacerbation in the previous 12 months .
METHODS	Children were randomised ( 1:1 ratio , by computer-generated sequence with permuted block design , stratified by study site and exacerbation frequency [ 1-2 vs 3 episodes in the preceding 12 months ] ) to receive either azithromycin ( 30 mg/kg ) or placebo once a week for up to 24 months .
METHODS	Allocation concealment was achieved by double-sealed , opaque envelopes ; participants , caregivers , and study personnel were masked to assignment until after data analysis .
METHODS	The primary outcome was exacerbation ( respiratory episodes treated with antibiotics ) rate .
METHODS	Analysis of the primary endpoint was by intention to treat .
METHODS	At enrolment and at their final clinic visits , children had deep nasal swabs collected , which we analysed for antibiotic-resistant bacteria .
METHODS	This study is registered with the Australian New Zealand Clinical Trials Registry ; ACTRN12610000383066 .
RESULTS	45 children were assigned to azithromycin and 44 to placebo .
RESULTS	The study was stopped early for feasibility reasons on Dec 31 , 2011 , thus children received the intervention for 12-24 months .
RESULTS	The mean treatment duration was 207 months ( SD 57 ) , with a total of 902 child-months in the azithromycin group and 875 child-months in the placebo group .
RESULTS	Compared with the placebo group , children receiving azithromycin had significantly lower exacerbation rates ( incidence rate ratio 050 ; 95 % CI 035-071 ; p < 00001 ) .
RESULTS	However , children in the azithromycin group developed significantly higher carriage of azithromycin-resistant bacteria ( 19 of 41 , 46 % ) than those receiving placebo ( four of 37 , 11 % ; p = 0002 ) .
RESULTS	The most common adverse events were non-pulmonary infections ( 71 of 112 events in the azithromycin group vs 132 of 209 events in the placebo group ) and bronchiectasis-related events ( episodes or investigations ; 22 of 112 events in the azithromycin group vs 48 of 209 events in the placebo group ) ; however , study drugs were well tolerated with no serious adverse events being attributed to the intervention .
CONCLUSIONS	Once-weekly azithromycin for up to 24 months decreased pulmonary exacerbations in Indigenous children with non-cystic-fibrosis bronchiectasis or chronic suppurative lung disease .
CONCLUSIONS	However , this strategy was also accompanied by increased carriage of azithromycin-resistant bacteria , the clinical consequences of which are uncertain , and will need careful monitoring and further study .
BACKGROUND	National Health and Medical Research Council ( Australia ) and Health Research Council ( New Zealand ) .

###24957785
OBJECTIVE	To examine whether insulin glargine can lead to better control of glycated haemoglobin ( HbA1c ) than that achieved by neutral protamine Hagedorn ( NPH ) insulin , using a protocol designed to limit nocturnal hypoglycaemia .
METHODS	The present study , the Least One Oral Antidiabetic Drug Treatment ( LANCELOT ) Study , was a 36-week , randomized , open-label , parallel-arm study conducted in Europe , Asia , the Middle East and South America .
METHODS	Participants were randomized ( 1:1 ) to begin glargine or NPH , on background of metformin with glimepiride .
METHODS	Weekly insulin titration aimed to achieve median prebreakfast and nocturnal plasma glucose levels 5.5 mmol/l , while limiting values 4.4 mmol/l .
RESULTS	The efficacy population ( n = 701 ) had a mean age of 57 years , a mean body mass index of 29.8 kg/m , a mean duration of diabetes of 9.2 years and a mean HbA1c level of 8.2 % ( 66mmol/mol ) .
RESULTS	At treatment end , HbA1c values and the proportion of participants with HbA1c < 7.0 % ( < 53mmol/mol ) were not significantly different for glargine [ 7.1 % ( 54mmol/mol ) and 50.3 % ] versus NPH [ 7.2 % ( 55mmol/mol ) and 44.3 % ] .
RESULTS	The rate of symptomatic nocturnal hypoglycaemia , confirmed by plasma glucose 3.9 or 3.1 mmol/l , was 29 and 48 % less with glargine than with NPH insulin .
RESULTS	Other outcomes were similar between the groups .
CONCLUSIONS	Insulin glargine was not superior to NPH insulin in improving glycaemic control .
CONCLUSIONS	The insulin dosing algorithm was not sufficient to equalize nocturnal hypoglycaemia between the two insulins .
CONCLUSIONS	This study confirms , in a globally heterogeneous population , the reduction achieved in nocturnal hypoglycaemia while attaining good glycaemic control with insulin glargine compared with NPH , even when titrating basal insulin to prevent nocturnal hypoglycaemia rather than treating according to normal fasting glucose levels .

###25210140
BACKGROUND	Vaccines against norovirus , the leading cause of acute gastroenteritis , should protect against medically significant illness and reduce transmission .
METHODS	In this randomized , double-blind , placebo-controlled trial , 18 - to 50-year-olds received 2 injections of placebo or norovirus GI .1 / GII .4 bivalent vaccine-like particle ( VLP ) vaccine with 3-O-desacyl-4 ' - monophosphoryl lipid A ( MPL ) and alum .
METHODS	Participants were challenged as inpatients with GII .4 virus ( 4400 reverse transcription polymerase chain reaction [ RT-PCR ] units ) , and monitored for illness and infection .
RESULTS	Per protocol , 27 of 50 ( 54.0 % ) vaccinees and 30 of 48 ( 62.5 % ) controls were infected .
RESULTS	Using predefined illness and infection definitions , vaccination did not meet the primary endpoint , but self-reported cases of severe ( 0 % vaccinees vs. 8.3 % controls ; P = .054 ) , moderate or greater ( 6.0 % vs. 18.8 % ; P = .068 ) , and mild or greater severity of vomiting and/or diarrhea ( 20.0 % vs. 37.5 % ; P = .074 ) were less frequent .
RESULTS	Vaccination also reduced the modified Vesikari score from 7.3 to 4.5 ( P = .002 ) .
RESULTS	Difficulties encountered were low norovirus disease rate , and inability to define illness by quantitative RT-PCR or further antibody rise in vaccinees due to high vaccine-induced titers .
RESULTS	By day 10 , 11 of 49 ( 22.4 % ) vaccinees were shedding virus compared with 17 of 47 ( 36.2 % ) placebo recipients ( P = .179 ) .
CONCLUSIONS	Bivalent norovirus VLP vaccine reduced norovirus-related vomiting and/or diarrhea ; field efficacy studies are planned .
CONCLUSIONS	Clinical Trials Registration .
CONCLUSIONS	NCT01609257 .

###24346114
BACKGROUND	Amphetamine challenge in rodent prepulse inhibition ( PPI ) studies has been used to model potential dopamine involvement in effects that may be relevant to schizophrenia , though similar studies in healthy humans have failed to report replicable or robust effects .
OBJECTIVE	The present study investigated dexamphetamine effects on PPI in healthy humans with an increased dose and a range of startling stimulus intensities to determine participants ' sensitivity and range of responses to the stimuli .
METHODS	A randomised , placebo-controlled dexamphetamine ( 0.45 mg/kg , per os . )
METHODS	, double-blind , counterbalanced , within-subject design was used .
METHODS	PPI was measured in 64 participants across a range of startling stimulus intensities , during two attention set conditions ( ATTEND and IGNORE ) .
METHODS	Startle magnitudes for pulse-alone and prepulse-pulse magnitudes were modelled using the startle reflex magnitude ( sigmoid ) function .
METHODS	Parameters were extracted from these fits , including the upper limit of the asymptote ( maximum startle reflex capacity , R MAX ) , intensity threshold , stimulus intensity that elicits a half-maximal response ( ES50 ) and the maximum rate of change of startle response magnitude to an increase in stimulus intensity .
RESULTS	Dexamphetamine increased the threshold and ES50 of the response to pulse-alone trials in both sexes and reduced R MAX exclusively in females .
RESULTS	Dexamphetamine modestly increased PPI of the R MAX across both attention conditions .
RESULTS	PPI of R MAX was reduced during the ATTEND condition compared to the IGNORE condition .
CONCLUSIONS	Results indicate that sex differences exist in motor , but not sensory , components of the startle reflex .
CONCLUSIONS	Findings also reveal that administration of 0.45 mg/kg dexamphetamine to healthy humans does not mimic PPI effects observed in schizophrenia .

###25539467
BACKGROUND	Corticosteroid withdrawal ( CW ) after pediatric kidney transplantation potentially improves growth while avoiding metabolic and other adverse events .
BACKGROUND	We have recently reported the results of a 196 subject randomized controlled trial comparing early CW ( tacrolimus , mycophenolate mofetil ( MMF ) , daclizumab , and corticosteroids until day 4 ) with tacrolimus , MMF , and corticosteroid continuation ( CC ) .
BACKGROUND	At 6 months , CW subjects showed better growth with no adverse impact on acute rejection or graft survival ( Am J Transplant 2010 ; 10 : 828-836 ) .
BACKGROUND	This 2-year investigator-driven follow-up study aimed to determine whether improved growth persisted in the longer term .
METHODS	Data regarding growth , graft outcomes and adverse events were collected at 1 year ( 113 patients ) and 2 years ( 106 patients ) after transplantation .
METHODS	The primary endpoint , longitudinal growth calculated as delta height standard deviation score , was analyzed using a mixed model repeated measures model .
RESULTS	Corticosteroid withdrawal subjects grew better at 1 year ( difference in adjusted mean change , 0.25 ; 95 % confidence interval , 0.10 , 0.40 ; P = 0.001 ) .
RESULTS	At 2 years , growth remained numerically better in CW subjects ( 0.20 ( -0.01 , 0.41 ) ; P = 0.06 ) , and significantly better in prepubertal subjects ( 0.50 ( 0.16 , 0.84 ) ; P = 0.004 ) .
RESULTS	Bacterial and viral infection was significantly more common in CW subjects at 1 year only .
RESULTS	Corticosteroid withdrawal and CC subjects received similar exposure to both tacrolimus and MMF at 1 and 2 years .
RESULTS	No significant difference in patient or graft survival , rejection , estimated glomerular filtration rate , or other adverse events was detected .
CONCLUSIONS	Early CW effectively and safely improves growth up to 2 years after transplantation , particularly in prepubertal children .

###25306557
BACKGROUND	Persistent eosinophilic airway inflammation in asthma increases the risk of exacerbations .
BACKGROUND	In a phase 2b dose-ranging study , we aimed to assess the efficacy and safety of benralizumab , an anti-interleukin 5 receptor monoclonal antibody that depletes blood and airway eosinophils , in adults with uncontrolled eosinophilic asthma .
METHODS	We did a randomised , controlled , double-blind , dose-ranging phase 2b study .
METHODS	Eligible participants were adults aged 18-75 years with uncontrolled asthma using medium-dose or high-dose inhaled corticosteroids and longacting agonists , with two to six exacerbations in the past year .
METHODS	Current or former smokers were excluded .
METHODS	We used the ELEN index ( an algorithm to predict elevated sputum eosinophils ) or baseline fraction of exhaled nitric oxide to stratify patients by eosinophilic status , and with an interactive web-voice response system randomly assigned eosinophilic individuals in a 1:1:1:1 ratio to receive placebo , 2 mg benralizumab , 20 mg benralizumab , or 100 mg benralizumab , and non-eosinophilic individuals in a 1:1 ratio to receive placebo or 100 mg benralizumab .
METHODS	Study drugs were given as two subcutaneous injections every 4 weeks for the first three doses , then every 8 weeks , for 1 year .
METHODS	Patients , treating physicians , and study investigators were masked to treatment allocation .
METHODS	The primary endpoint was annual exacerbation rate in eosinophilic individuals after 1 year of follow-up .
METHODS	Analysis was by modified intention to treat .
METHODS	This study was designed with a two-sided of 02 and powered at 78 % for the primary outcome in the eosinophilic population .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01238861 .
RESULTS	Between Jan 3 , 2011 , and March 6 , 2012 , we randomly assigned 324 eosinophilic individuals to placebo ( n = 80 ) or benralizumab 2 mg dose ( n = 81 ) , 20 mg dose , ( n = 81 ) , or 100 mg dose ( n = 82 ) , and 285 non-eosinophilic individuals to 100 mg benralizumab ( n = 142 , 140 included in analysis ) or placebo ( n = 143 , 142 included in analysis ) .
RESULTS	In eosinophilic individuals , benralizumab reduced exacerbation rates compared with placebo in the 100 mg group ( 034 vs 057 , reduction 41 % , 80 % CI 11 to 60 , p = 0096 ) but not in the 2 mg group ( 065 vs 057 , difference -9 % , 80 % CI -59 to 26 , p = 0781 ) or the 20 mg group ( 037 vs 057 , reduction 36 % , 80 % CI 3 to 58 , p = 0173 ) .
RESULTS	In patients with a baseline blood eosinophil cutoff of at least 300 cells per L , exacerbation rates in the benralizumab 20 mg group ( n = 70 ) and 100 mg group ( n = 97 ) were lower than in the placebo group ( n = 83 ; 030 vs 068 , reduction 57 % , 80 % CI 33 to 72 , p = 0015 for 20 mg dose ; 038 vs 068 , difference 43 % , 80 % CI 18 to 60 , p = 0049 for 100 mg dose ) .
RESULTS	Our findings suggested that benralizumab 20 mg and 100 mg resided at the dose-response plateau .
RESULTS	Treatment-emergent adverse events occurred in 277 ( 72 % ) of 385 participants receiving any benralizumab dose compared with 143 ( 65 % ) of 221 receiving placebo .
RESULTS	Nasopharyngitis ( 44 [ 11 % ] patients receiving benralizumab vs 13 [ 6 % ] patients receiving placebo ) and injection site reactions ( 60 [ 16 % ] vs eight [ 4 % ] ) occurred more frequently with benralizumab than with placebo .
CONCLUSIONS	Benralizumab at 20 mg and 100 mg doses seemed to reduce asthma exacerbations in adults with uncontrolled eosinophilic asthma and baseline blood eosinophils of at least 300 cells per L , possibly due to targeting of the interleukin 5 receptor rather than interleukin 5 ligand .
CONCLUSIONS	Further investigation of benralizumab treatment in phase 3 studies is warranted .
BACKGROUND	MedImmune .

###24491069
OBJECTIVE	We evaluated 3 methods of integrating interventions for depression ( Adolescent Coping With Depression Course ; CWD ) and substance use disorders ( Functional Family Therapy ; FFT ) , examining ( a ) treatment sequence effects on substance use and depression outcomes and ( b ) whether the presence of major depressive disorder ( MDD ) moderated effects .
METHODS	Participants were 170 adolescents ( ages 13-18 ; 22 % female ; 61 % non-Hispanic White ) with comorbid depressive disorder ( 54 % MDD , 18 % dysthymia ) and substance use disorders who were randomized to ( a ) FFT followed by CWD ( FFT/CWD ) , ( b ) CWD followed by FFT ( CWD/FFT ) , or ( c ) coordinated FFT and CWD ( CT ) .
METHODS	Acute treatment ( 24 treatment sessions provided over 20 weeks ) and 6 - and 12-month follow-up effects are presented for substance use ( percentage of days of substance use ; Timeline Followback ) and depression ( Children 's Depression Rating Scale-Revised ) .
RESULTS	FFT/CWD achieved better substance use outcomes than CT at posttreatment , and 6 - and 12-month follow-ups ; substance use effects for CWD/FFT were intermediate .
RESULTS	For participants with baseline MDD , the CWD/FFT sequence resulted in lower substance use than either FFT/CWD or CT. .
RESULTS	Depressive symptoms decreased significantly in all 3 treatment sequences with no evidence of differential effectiveness during or following treatment .
RESULTS	Attendance was lower for the second of both sequenced interventions .
RESULTS	A large proportion of the sample received treatment outside the study , which predicted better outcomes in the follow-up .
CONCLUSIONS	Depression reductions occurred early in all 3 treatment sequences .
CONCLUSIONS	Of the examined treatment sequences , FFT/CWD appeared most efficacious for substance use reductions but addressing depression early in treatment may improve substance use outcomes in the presence of MDD .

###25231008
OBJECTIVE	Drug development in chronic obstructive pulmonary disease ( COPD ) has been characterised by unacceptably high failure rates .
OBJECTIVE	In addition to the poor sensitivity in forced expiratory volume in one second ( FEV1 ) , numerous causes are known to contribute to this phenomenon , which can be clustered into drug - , disease - and design-related factors .
OBJECTIVE	Here we present a model-based approach to describe disease progression , treatment response and dropout in clinical trials with COPD patients .
METHODS	Data from six phase II trials lasting up to 6 months were used .
METHODS	Disease progression ( trough FEV1 measurements ) was modelled by a time-varying function , whilst the treatment effect was described by an indirect response model .
METHODS	A time-to-event model was used for dropout
RESULTS	All relevant parameters were characterised with acceptable precision .
RESULTS	Two parameters were necessary to model the dropout patterns , which was found to be partly linked to the treatment failure .
RESULTS	Disease severity at baseline , previous use of corticosteroids , gender and height were significant covariates on disease baseline whereas disease severity and reversibility to salbutamol/salmeterol were significant covariates on Emax for salmeterol active arm .
CONCLUSIONS	Incorporation of the various interacting factors into a single model will offer the basis for patient enrichment and improved dose rationale in COPD .

###24749354
OBJECTIVE	To evaluate the efficacy and safety of domestically produced Salbutamol Sulfate metered dose inhaler ( MDI ) without chloro-fluro-carbon ( CFC ) in the treatment of asthmatic patients .
METHODS	A muticenter , randomized , double-blind , positive controlled clinical trial was conducted in asthmatic patients .
METHODS	The participants were randomized divided into trial group treated with domestically produced Salbutamol Sulfate Aerosol MDI ( 200 microg single-dose ) and control group treated with imported Salbutamol Sulfate Aerosol MDI ( 200 microg single-dose ) .
METHODS	The lung function was measured by spirometry and a scoring questionaire before medications and 15 , 30 , 120 and 240 min post medications .
RESULTS	A total of 238 patients were enrolled in the trial .
RESULTS	Compared with baselines , the forced expiratory volume in 1 s ( FEV1 ) of the participants in both groups increased significantly 15 , 30 , 120 and 240 min after medications ( P < 0.05 ) .
RESULTS	There was no significant difference in the changes of FEV1 between the two groups ( P > 0.05 ) .
RESULTS	Similarly , the forced vital capacity ( FVC ) and asthma symptomatic scores of the participants in both groups improved significantly after administration of medications ( P < 0.05 ) .
RESULTS	There was no significant difference in the ratio of adverse reactions between the two groups ( P > 0.05 ) .
RESULTS	In both groups , drugs were well tolerated .
CONCLUSIONS	The domestically produced Salbutamol Sulfate Aerosol MDI without CFC is effective and safe for treating asthma .

###24299928
BACKGROUND	The effect of single low-dose dexamethasone therapy on perioperative blood glucose concentrations has not been well characterized .
BACKGROUND	In this investigation , we examined the effect of 2 commonly used doses of dexamethasone ( 4 and 8 mg at induction of anesthesia ) on blood glucose concentrations during the first 24 hours after administration .
METHODS	Two hundred women patients were randomized to 1 of 6 groups : Early-control ( saline ) ; Early-4 mg ( 4 mg dexamethasone ) ; Early-8 mg ( 8 mg dexamethasone ) ; Late-control ( saline ) ; Late-4 mg ( 4 mg dexamethasone ) ; and Late-8 mg ( 8 mg dexamethasone ) .
METHODS	Blood glucose concentrations were measured at baseline and 1 , 2 , 3 , and 4 hours after administration in the early groups and at baseline and 8 and 24 hours after administration in the late groups .
METHODS	The incidence of hyperglycemic events ( the number of patients with at least 1 blood glucose concentration > 180 mg/dL ) was determined .
RESULTS	Blood glucose concentrations increased significantly over time in all control and dexamethasone groups ( from median baselines of 94 to 102 mg/dL to maximum medians ranging from 141 to 161.5 mg/dL , all P < 0.001 ) .
RESULTS	Blood glucose concentrations did not differ significantly between the groups receiving dexamethasone ( either 4 or 8 mg ) and those receiving saline at any measurement time .
RESULTS	The incidence of hyperglycemic events did not differ in any of the early ( 21 % -28 % , P = 0.807 ) or late ( 13 % -24 % , P = 0.552 ) groups .
CONCLUSIONS	Because blood glucose concentrations during the first 24 hours after administration of single low-dose dexamethasone did not differ from those observed after saline administrations , these results suggest clinicians need not avoid using dexamethasone for nausea and vomiting prophylaxis out of concerns related to hyperglycemia .

###25239603
BACKGROUND	Nausea and vomiting can occur in Parkinson 's disease ( PD ) patients initiated on apomorphine subcutaneous injections and antiemetic prophylaxis is recommended per product labeling .
BACKGROUND	Data suggest long-term antiemetic prophylaxis may not be needed , although this has not been systematically studied .
METHODS	We evaluated coadministered trimethobenzamide with apomorphine in 182 PD subjects using a randomized , double-blind , placebo-controlled design , with phased withdrawal of subjects from trimethobenzamide to placebo .
METHODS	Evaluations included presence/absence of nausea and vomiting ; Index of Nausea , Vomiting , and Retching ( INVR ) ; subject evaluation of medication ; Unified Parkinson 's Disease Rating Scale ( UPDRS ) motor score ; `` on '' response post-injection ; and safety assessments .
RESULTS	Incidence of nausea and/or vomiting on Day 1 of apomorphine initiation ( primary endpoint ) was not significantly different between trimethobenzamide and placebo .
RESULTS	Over a longer period , a significantly lower incidence was found for trimethobenzamide during Period 1 ( Days 1-28 , p = 0.025 ) and Period 2 ( Days 29-56 , p = 0.005 ) , with no difference during Period 3 ( Days 57-84 ) .
RESULTS	INVR results were generally more favorable with trimethobenzamide than placebo in Period 1 and significantly more favorable in Period 2 .
RESULTS	The majority of subjects in both groups achieved an `` on '' response after apomorphine injection at all assessments .
RESULTS	No significant differences were found between groups for UPDRS motor scores .
RESULTS	No added safety risk with concomitant use of trimethobenzamide and apomorphine was found .
CONCLUSIONS	Our data suggest that trimethobenzamide helps reduce nausea/vomiting during the first 8 weeks of apomorphine therapy , but is generally not needed thereafter .
CONCLUSIONS	Trimethobenzamide did not worsen parkinsonism nor affect `` on '' response after apomorphine injection .

###24345071
OBJECTIVE	To evaluate the association between outdoor and nearwork activities at baseline and myopia stabilisation by age 15 in the Correction of Myopia Evaluation Trial ( COMET ) .
METHODS	Correction of Myopia Evaluation Trial enrolled 469 children ( ages : 6-11years ) with spherical equivalent myopia between -1.25 and -4.50 D , who were randomised to progressive addition or single vision lenses and followed for 5years in their original lenses .
METHODS	At baseline , families recorded the child 's outdoor and nearwork activities for 3days within a week .
METHODS	Weekly hours spent in nearwork and outdoor activities were calculated for each participant .
METHODS	Refractions collected over 11years were fit using the Gompertz function to determine each participant 's myopia stabilisation age .
METHODS	Myopia for each child was then categorized as stable/not stable by age 15 .
RESULTS	Half ( 233/469 ) of participants had usable baseline activity diaries and refraction data that could be fit with the Gompertz function , 59.7 % ( 139/233 ) had stable myopia by age 15 and 40.3 % had myopia that was not yet stable .
RESULTS	The frequency of stable myopia was similar for the two categories ( median split ) of outdoor activities : 60 % ( 71/118 ) for 9.0 hours/week ( -1 ) and 59 % ( 68/115 ) for > 9.0 hours/week ( -1 ) .
RESULTS	56 % ( 64/114 ) of children reporting > 21.0 h of baseline weekly nearwork activity had stable myopia by age 15 compared to 63 % ( 75/119 ) with 21.0 h of near work ( adjusted OR = 0.74 ; 95 % CI : 0.43-1 .29 ) .
RESULTS	Using baseline nearwork as a continuous variable , the multivariable odds ratio for the association between baseline nearwork hours and stabilisation by age 15 is 0.98 : 95 % CI : 0.96-1 .00 , a result trending towards significance .
CONCLUSIONS	While time spent in outdoor activities in childhood does not appear to be related to myopia stabilisation by age 15 , less near work activity might potentially be associated with myopia stabilisation by that age .

###24286114
BACKGROUND	The long-term safety and therapeutic response of sodium oxybate ( SXB ) in fibromyalgia syndrome ( FM ) patients were assessed for a combined period of up to 1 year in a prospective , multicenter , open-label , extension study in patients completing 1 of 2 phase 3 randomized , double-blind , controlled , 14-week trials that examined the efficacy and safety of SXB 4.5 g , SXB 6 g , and placebo for treatment of FM .
METHODS	This extension study comprised an additional 38 weeks of treatment and was carried out at 130 clinical sites in 7 countries .
METHODS	Initial entry criteria for the previous 2 double-blind clinical trials required that patients aged 18 years met the American College of Rheumatology 1990 criteria for FM , had a body mass index ( BMI ) < 40 kg/m2 , and had a score 50 on a 100-mm pain visual analog scale ( VAS ) at baseline .
METHODS	All patients began treatment in the extension study with SXB 4.5 g/night ( administered in 2 equally divided doses ) for at least 1 week , followed by possible serial 1.5 g/night dose increases to 9 g/night ( maximum ) or reductions to 4.5 g/night ( minimum ) .
RESULTS	Of the 560 FM patients enrolled in this extension study , 319 ( 57.0 % ) completed the study .
RESULTS	The main reason for early discontinuation was adverse events ( AEs ; 23.0 % of patients ) .
RESULTS	Patients were primarily middle-aged ( mean 46.910.8 years ) , female ( 91.1 % ) , white ( 91.4 % ) , with a mean duration of FM symptoms of 9.98.7 years .
RESULTS	Serious AEs were experienced by 3.6 % of patients .
RESULTS	The most frequently reported AEs ( incidence 5 % at any dose or overall ) were nausea , headache , dizziness , nasopharyngitis , vomiting , sinusitis , diarrhea , anxiety , insomnia , influenza , somnolence , upper respiratory tract infection , muscle spasms , urinary tract infection , and gastroenteritis viral .
RESULTS	Maintenance of SXB therapeutic response was demonstrated with continued improvement from controlled-study baseline in pain VAS , Fibromyalgia Impact Questionnaire ( FIQ ) total scores , and other measures .
RESULTS	Responder analyses showed that 68.8 % of patients achieved 30 % reduction in pain VAS and 69.7 % achieved 30 % reduction in FIQ total score at study endpoint .
CONCLUSIONS	The long-term safety profile of SXB in FM patients was similar to that in the previously reported controlled clinical trials .
CONCLUSIONS	Improvement in pain and other FM clinical domains was maintained during long-term use .
BACKGROUND	ClinicalTrials.gov NCT00423605 .

###25078053
OBJECTIVE	To evaluate the efficacy of the stair-step protocol using clomiphene citrate ( CC ) and to assess the uterine and systemic side effects in patients with polycystic ovary syndrome ( PCOS ) .
METHODS	A total of 60 PCOS patients who failed to respond to 50mg/day for 5days of CC treatment within the cycle were randomly allocated to the control ( traditional protocol ) and study ( stair-step protocol ) groups .
METHODS	In the stair-step protocol , patients were treated with CC 50mg/day for 5days and then in nonresponsive patients , the dosage was increased to 100mg/day for 5days in the same cycle .
METHODS	Patients who failed the 50mg/day CC treatment in the previous cycle were stimulated with 100mg/day CC and were accepted as the control group .
METHODS	Ovulation and pregnancy rates , duration of treatment and uterine and systemic side effects were evaluated .
RESULTS	Ovulation and pregnancy rates were similar between the stair-step and the control group ( 43.3 vs. 33.3 % , respectively ) ( 16.7 vs. 10 % , respectively ) .
RESULTS	The duration of treatment was significantly shorter in stair-step compared to traditional protocol ( 20.52.0 vs. 48.62.4 days , respectively ) .
RESULTS	There were no significant differences in the systemic side effects between the groups .
RESULTS	Uterine side effects were evaluated with endometrial thickness and uterine artery Doppler ultrasound ; no significant differences were observed in stair-step compared to traditional protocol .
CONCLUSIONS	The stair-step protocol was determined to have a significantly shorter treatment period without any detrimental effect on the ovulation and pregnancy rates .

###24424070
BACKGROUND	Patient blood management combines the use of several transfusion alternatives .
BACKGROUND	Integrated use of erythropoietin , cell saver , and/or postoperative drain reinfusion devices on allogeneic erythrocyte use was evaluated using a restrictive transfusion threshold .
METHODS	In a factorial design , adult elective hip - and knee-surgery patients with hemoglobin levels 10 to 13 g/dl ( n = 683 ) were randomized for erythropoietin or not , and subsequently for autologous reinfusion by cell saver or postoperative drain reinfusion devices or for no blood salvage device .
METHODS	Primary outcomes were mean allogeneic intra - and postoperative erythrocyte use and proportion of transfused patients ( transfusion rate ) .
METHODS	Secondary outcome was cost-effectiveness .
RESULTS	With erythropoietin ( n = 339 ) , mean erythrocyte use was 0.50 units ( U ) / patient and transfusion rate 16 % while without ( n = 344 ) , these were 0.71 U/patient and 26 % , respectively .
RESULTS	Consequently , erythropoietin resulted in a nonsignificant 29 % mean erythrocyte reduction ( ratio , 0.71 ; 95 % CI , 0.42 to 1.13 ) and 50 % reduction of transfused patients ( odds ratio , 0.5 ; 95 % CI , 0.35 to 0.75 ) .
RESULTS	Erythropoietin increased costs by 785 per patient ( 95 % CI , 262 to 1,309 ) , that is , 7,300 per avoided transfusion ( 95 % CI , 1,900 to 24,000 ) .
RESULTS	With autologous reinfusion , mean erythrocyte use was 0.65 U/patient and transfusion rate was 19 % with erythropoietin ( n = 214 ) and 0.76 U/patient and 29 % without ( n = 206 ) .
RESULTS	Compared with controls , autologous blood reinfusion did not result in erythrocyte reduction and increased costs by 537 per patient ( 95 % CI , 45 to 1,030 ) .
CONCLUSIONS	In hip - and knee-replacement patients ( hemoglobin level , 10 to 13 g/dl ) , even with a restrictive transfusion trigger , erythropoietin significantly avoids transfusion , however , at unacceptably high costs .
CONCLUSIONS	Autologous blood salvage devices were not effective .

###25155227
OBJECTIVE	The safety and efficacy of adalimumab for patients with moderately to severely active ulcerative colitis ( UC ) has been reported up to week 52 from the placebo-controlled trials ULTRA ( Ulcerative Colitis Long-Term Remission and Maintenance with Adalimumab ) 1 and 2 .
OBJECTIVE	Up to 4 years of data for adalimumab-treated patients from ULTRA 1 , 2 , and the open-label extension ULTRA 3 are presented .
METHODS	Remission per partial Mayo score , remission per Inflammatory Bowel Disease Questionnaire ( IBDQ ) score , and mucosal healing rates were assessed in adalimumab-randomized patients from ULTRA 1 and 2 up to week 208 .
METHODS	Corticosteroid-free remission was assessed in adalimumab-randomized patients who used corticosteroids at lead-in study baseline .
METHODS	Maintenance of remission per partial Mayo score and mucosal healing was assessed in patients who entered ULTRA 3 in remission per full Mayo score and with mucosal healing , respectively .
METHODS	As observed , last observation carried forward ( LOCF ) and nonresponder imputation ( NRI ) were used to report efficacy .
METHODS	Adverse events were reported for any adalimumab-treated patient .
RESULTS	A total of 600/1 ,094 patients enrolled in ULTRA 1 or 2 were randomized to receive adalimumab and included in the intent-to-treat analyses of the studies .
RESULTS	Of these , 199 patients remained on adalimumab after 4 years of follow-up .
RESULTS	Rates of remission per partial Mayo score , remission per IBDQ score , mucosal healing , and corticosteroid discontinuation at week 208 were 24.7 % , 26.3 % , 27.7 % ( NRI ) , and 59.2 % ( observed ) , respectively .
RESULTS	Of the patients who were followed up in ULTRA 3 ( 588/1 ,094 ) , a total of 360 patients remained on adalimumab 3 years later .
RESULTS	Remission per partial Mayo score and mucosal healing after ULTRA 1 or 2 to year 3 of ULTRA 3 were maintained by 63.6 % and 59.9 % of patients , respectively ( NRI ) .
RESULTS	Adverse event rates were stable over time .
CONCLUSIONS	Remission , mucosal healing , and improved quality of life were maintained in patients with moderately to severely active UC with long-term adalimumab therapy , for up to 4 years .
CONCLUSIONS	No new safety signals were reported .

###25119540
BACKGROUND	Robotic thyroidectomy ( RoT ) is frequently performed due to its excellent cosmesis and recovery features .
BACKGROUND	However , postoperative pain in the operating field after RoT remains a concern due to extensive tissue dissection and tension during the operation .
BACKGROUND	The aim of this study was to evaluate the anterior chest pain and the effect of levobupivacaine spraying on postoperative pain control after bilateral axillo-breast approach ( BABA ) RoT .
METHODS	We randomized 55 adult patients scheduled for BABA RoT into the control group ( group C , n = 27 ) or the levobupivacaine group ( group L , n = 28 ) .
METHODS	At the end of surgery , patients in groups C and L were sprayed with the same volume ( 30 ml ) of normal saline and 0.25 % levobupivacaine , respectively , on the flap dissection area .
METHODS	Pain scores , the consumption of patient-controlled analgesia ( PCA ) , and other adverse effects were assessed at 1 , 6 , 24 , and 48 h postoperatively .
RESULTS	Patients in group L showed lower pain scores than those of group C at 1 h ( 50 [ 0-100 ] vs. 80 [ 20-100 ] ; p = 0.004 ) , 6 h ( 30 [ 0-90 ] vs. 70 [ 30-90 ] ; p < 0.001 ) , 24 h ( 30 [ 0-80 ] vs. 50 [ 10-80 ] ; p = 0.016 ) and 48 h ( 10 [ 0-80 ] vs. 30 [ 10-80 ] ; p < 0.001 ) postoperatively .
RESULTS	PCA consumption of group L was less than that of group C at 6 , 24 , and 48 h after surgery .
RESULTS	There were no significant differences in postoperative nausea-vomiting , headache , or dizziness .
RESULTS	Local anesthetic-related adverse effects were not reported .
CONCLUSIONS	Levobupivacaine spray on the operative field at the end of BABA RoT reduced postoperative pain and PCA consumption without adverse events .

###25138784
OBJECTIVE	In dental applications , as in all other medical applications , pain needs to be prevented or at least controlled .
OBJECTIVE	The use of the tooth as a model for studying pain mechanisms is well established .
OBJECTIVE	In the current study , we aimed to evaluate and compare the analgesic effects of gabapentin and lornoxicam , respectively , vs a placebo for postendodontic treatment pain .
METHODS	Clinical research was planned as prospective , randomized , and placebo controlled .
METHODS	Each subject was given 600mg gabapentin ( group G : N = 30 ) , 8mg lornoxicam ( group L : N = 30 ) , or a placebo ( group C : N = 30 ) 30 min prior to endodontic treatment .
METHODS	At 4 ( T ( 3 ) ) , 8 ( T ( 4 ) ) , 12 ( T ( 5 ) ) , and 24 ( T ( 6 ) ) h after preoperative ( T ( 0 ) ) time points , the analgesic efficacies of the agents were evaluated by using the visual analog scale ( VAS ) .
RESULTS	In group G , VAS values were significantly greater at T ( 0 ) time point than at T ( 5 ) or T ( 6 ) .
RESULTS	T ( 0 ) time point VAS value in group L was lower than at T4 time point and greater than at T ( 6 ) .
RESULTS	In group C , T ( 0 ) time point VAS values were significantly lower at T ( 3 ) and T ( 5 ) time points and greater than at T ( 6 ) time point .
RESULTS	VAS values in group G at T ( 5 ) time point were significantly lower than in group C or group L ( P < 0.05 ) .
CONCLUSIONS	Based on the obtained data , prophylactic lornoxicam controlled postendodontic treatment pain more effectively than did the placebo drugs , and gabapentin was more effective in controlling the pain than either lornoxicam or the placebo .

###24605710
OBJECTIVE	To compare the outcomes of the nasal obstruction , the main symptom of the patients who underwent radiofrequency and lateral displacement of the inferior turbinate and patients who were treated with radiofrequency alone .
METHODS	The prospective randomised study was conducted at the Department of Otorhinolaryngology and Head-Neck Surgery , Balikesir University Medical School , Balikesir , Turkey , between July and December 2012 .
METHODS	It included 60 patients , diagnosed with allergic or non-allergic chronic rhinitis with inferior turbinate hypertrophy which was refractory to medical therapy .
METHODS	Half of the patients were treated with radiofrequency , and the rest with radiofrequency and lateral displacement .
METHODS	The main symptom of the patients was nasal obstruction .
METHODS	The frequency and degree of nasal obstruction were evaluated by patients ' self-assessments using the standard 10-cm visual analogue scale .
METHODS	The evaluations were performed first pre-operatively and on the 1st , 3rd , 5th and 7th days postoperatively as well as at the end of the 4th week .
METHODS	SPSS 18 was used for statistical analysis .
RESULTS	Nasal obstruction frequency and severity scores in patients treated with both radiofrequency and lateral displacement on post-operative days 3 , 5 and 7 were found to be significantly lower ( p < 0.001 ) compared to the patients treated with only radiofrequency .
CONCLUSIONS	The study demonstrated that radiofrequency and lateral displacement together is an effective method to prevent inferior turbinate oedema in the early post-operative period .

###24325365
OBJECTIVE	Sarpogrelate is a selective 5-hydroxytryptamine receptor subtype 2A antagonist that inhibits platelet aggregation and vasoconstriction .
OBJECTIVE	The aim of this study was to compare the pharmacokinetics of a sarpogrelate controlled-release formulation ( CR ) with those of the immediate-release formulation ( IR ) .
OBJECTIVE	The effect of food on the pharmacokinetics of CR sarpogrelate was also evaluated .
METHODS	A randomized , open-label , 3-period , 3-treatment crossover study was conducted in 50 healthy male subjects .
METHODS	Subjects were allocated into one of six sequence groups .
METHODS	In one period , a 100-mg IR formulation was administered three times at 6-h intervals , and in the other two periods , a 300-mg CR formulation was administered once to fasting and once to fed subjects .
METHODS	Each period was separated by a 7-day washout period .
METHODS	Serial blood samples were collected up to 24h after the first drug administration in each period .
METHODS	The plasma concentrations of sarpogrelate were analysed by liquid chromatography-tandem mass spectrometry .
METHODS	Pharmacokinetic parameters were calculated by non-compartmental methods .
CONCLUSIONS	After the administration of the IR formulation , the plasma concentration reached a peak at 048h and the drug was eliminated with a half-life ( t1/2 ) of 07h .
CONCLUSIONS	After administration of the CR formulation , the plasma concentration reached a peak at 05h and the drug was eliminated with a t1/2 of 323h .
CONCLUSIONS	The geometric mean ratios ( CR/IR ) for sarpogrelate area under the plasma concentration-time curve ( AUC ) and the maximum plasma drug concentration ( Cmax ) were 12040 ( 90 % confidence interval ( CI ) : 10992-13188 ) and 09462 ( 90 % CI : 08504-10529 ) .
CONCLUSIONS	When CR was administered to fed subjects , the time to peak concentration was prolonged to 397h and t1/2 was shortened to 145h .
CONCLUSIONS	The geometric mean ratios ( fasting/fed ) for sarpogrelate AUC and Cmax were 08573 ( 90 % CI : 07687-09561 ) and 06452 ( 90 % CI : 05671-07341 ) .
CONCLUSIONS	After the administration of CR and IR formulations of the same daily dose of sarpogrelate hydrochloride , the overall systemic exposure was slightly higher for the CR than for the IR formulation , whereas peak concentration was comparable between the two formulations .
CONCLUSIONS	Food reduced the bioavailability of sarpogrelate CR .

###24393423
BACKGROUND	With increasing numbers of type 2 diabetes ( DM2 ) and hypertension patients , there is a pressing need for effective , time-efficient and sustainable strategies to help physicians support their patients to achieve higher physical activity levels .
BACKGROUND	SMARTER will determine whether physician-delivered step count prescriptions reduce arterial stiffness over a one-year period , compared with usual care , in sedentary overweight/obese adults with DM2/hypertension .
METHODS	Randomized , allocation-concealed , assessor-blind , multisite clinical trial .
METHODS	The primary outcome is change in arterial stiffness over one year .
METHODS	The secondary outcomes include changes in physical activity , individual vascular risk factors , medication use , and anthropometric parameters .
METHODS	Assessments are at baseline and one year .
METHODS	Participants are sedentary/low active adults with 25BMI < 40 kg/m2 followed for DM2/hypertension by a collaborating physician .
METHODS	The active arm uses pedometers to track daily step counts and review logs with their physicians at 3 to 4-month intervals .
METHODS	A written step count prescription is provided at each visit , aiming to increase counts by 3,000 steps/day over one year , with an individualized rate increase .
METHODS	The control arm visits physicians at the same frequency and receives advice to engage in physical activity 30-60 minutes/day .
METHODS	SMARTER will enroll 364 individuals to detect a 105 % difference in arterial stiffness change between arms .
METHODS	Arterial stiffness is assessed noninvasively with carotid femoral pulse wave velocity using applanation tonometry .
CONCLUSIONS	The importance of SMARTER lies not simply in the use of pedometer-based monitoring but also on its integration into a prescription-based intervention delivered by the treating physician .
CONCLUSIONS	Equally important is the measurement of impact of this approach on a summative indicator of arterial health , arterial stiffness .
CONCLUSIONS	If effectiveness is demonstrated , this strategy has strong potential for widespread uptake and implementation , given that it is well-aligned with the structure of current clinical practice .
BACKGROUND	ClinicalTrials.gov ( NCT01475201 ) .

###25977146
OBJECTIVE	To show non-inferiority of trimethoprim-sulfamethoxazole compared with vancomycin for the treatment of severe infections due to meticillin resistant Staphylococcus aureus ( MRSA ) .
METHODS	Parallel , open label , randomised controlled trial .
METHODS	Four acute care hospitals in Israel .
METHODS	Adults with severe infections caused by MRSA susceptible to trimethoprim-sulfamethoxazole and vancomycin .
METHODS	Patients with left sided endocarditis , meningitis , chronic haemodialysis , and prolonged neutropenia were excluded .
METHODS	Trimethoprim-sulfamethoxazole 320 mg/1600 mg twice daily versus vancomycin 1 g twice daily for a minimum of seven days and then by indication .
METHODS	The primary efficacy outcome was treatment failure assessed at day 7 , consisting of death , persistence of haemodynamic instability or fever , stable or worsening Sequential Organ Failure Assessment score , and persistence of bacteraemia .
METHODS	The primary safety outcome was all cause mortality at day 30 .
METHODS	Non-inferiority was defined by a difference of less than 15 % for treatment failure .
RESULTS	252 patients were included in the trial , of whom 91 ( 36 % ) had bacteraemia .
RESULTS	No significant difference in treatment failure was seen for trimethoprim-sulfamethoxazole ( 51/135 , 38 % ) versus vancomycin ( 32/117 , 27 % ) - risk ratio 1.38 ( 95 % confidence interval 0.96 to 1.99 ) .
RESULTS	However , trimethoprim-sulfamethoxazole did not meet the non-inferiority criterion-absolute difference 10.4 % ( 95 % confidence interval -1.2 % to 21.5 % ) .
RESULTS	For patients with bacteraemia , the risk ratio was 1.40 ( 0.91 to 2.16 ) .
RESULTS	In a multivariable logistic regression analysis , trimethoprim-sulfamethoxazole was significantly associated with treatment failure ( adjusted odds ratio 2.00 , 1.09 to 3.65 ) .
RESULTS	The 30 day mortality rate was 32/252 ( 13 % ) , with no significant difference between arms .
RESULTS	Among patients with bacteraemia , 14/41 ( 34 % ) treated with trimethoprim-sulfamethoxazole and 9/50 ( 18 % ) with vancomycin died ( risk ratio 1.90 , 0.92 to 3.93 ) .
CONCLUSIONS	High dose trimethoprim-sulfamethoxazole did not achieve non-inferiority to vancomycin in the treatment of severe MRSA infections .
CONCLUSIONS	The difference was particularly marked for patients with bacteraemia .
CONCLUSIONS	Trial registration Clinical trials NCT00427076 .

###25118962
OBJECTIVE	The study aims to evaluate the efficacy and safety of two Chinese herbal formulae for the treatment of stable COPD .
METHODS	A multicenter , double-blind , double-dummy , and randomized controlled trial ( RCT ) was conducted .
METHODS	All groups were treated with additional conventional medicines .
METHODS	There were a 6-month treatment and a 12-month follow-up for 5 times .
METHODS	Primary outcomes included lung function test , exacerbation frequency , score of SGRQ .
METHODS	Second outcomes consisted of 6MWD , BODE index , psychological field score , inflammatory factors and cortisol .
RESULTS	A total of 331 patients were randomly divided into two active treatment groups ( Bushen Yiqi ( BY ) granule group , n = 109 ; Bushen Fangchuan ( BF ) tablet group , n = 109 ) and a placebo group ( n = 113 ) .
RESULTS	Finally 262 patients completed the study .
RESULTS	BY granule & BF tablet increased the values of VC , FEV1 ( % ) and FEV1/FVC ( % ) , compared with placebo .
RESULTS	BY granule improved PEF .
RESULTS	Both treatments reduced acute exacerbation frequency ( P = 0.067 ) , BODE index and psychological field score , while improved 6MWD .
RESULTS	In terms of descent rang of SGRQ score , both treatments increased ( P = 0.01 ) .
RESULTS	Both treatments decreased inflammatory cytokines , such as IL-8 , and IL-17 ( P = 0.0219 ) .
RESULTS	BY granule obviously descended IL-17 ( P < 0.05 ) , IL-1 ( P = 0.05 ) , IL-6 , compared with placebo .
RESULTS	They improved the level of IL-10 and cortisol .
RESULTS	BY granule raised cortisol ( P = 0.07 ) and decreased TNF - .
RESULTS	Both treatments slightly descended TGF-1 .
RESULTS	In terms of safety , subject compliance and drug combination , there were no differences ( P > 0.05 ) among three groups .
CONCLUSIONS	BY granule and BF tablet were positively effective for the treatment of COPD , and the former performed better in general .
BACKGROUND	Chinese Clinical Trial Register center ChiCTR-TRC-09000530 .

###26040499
BACKGROUND	Adjuvant endocrine therapy compromises bone health in patients with breast cancer , causing osteopenia , osteoporosis , and fractures .
BACKGROUND	Antiresorptive treatments such as bisphosphonates prevent and counteract these side-effects .
BACKGROUND	In this trial , we aimed to investigate the effects of the anti-RANK ligand antibody denosumab in postmenopausal , aromatase inhibitor-treated patients with early-stage hormone receptor-positive breast cancer .
METHODS	In this prospective , double-blind , placebo-controlled , phase 3 trial , postmenopausal patients with early hormone receptor-positive breast cancer receiving treatment with aromatase inhibitors were randomly assigned in a 1:1 ratio to receive either denosumab 60 mg or placebo administered subcutaneously every 6 months in 58 trial centres in Austria and Sweden .
METHODS	Patients were assigned by an interactive voice response system .
METHODS	The randomisation schedule used a randomly permuted block design with block sizes 2 and 4 , stratified by type of hospital regarding Hologic device for DXA scans , previous aromatase inhibitor use , and baseline bone mineral density .
METHODS	Patients , treating physicians , investigators , data managers , and all study personnel were masked to treatment allocation .
METHODS	The primary endpoint was time from randomisation to first clinical fracture , analysed by intention to treat .
METHODS	As an additional sensitivity analysis , we also analysed the primary endpoint on the per-protocol population .
METHODS	Patients were treated until the prespecified number of 247 first clinical fractures was reached .
METHODS	This trial is ongoing ( patients are in follow-up ) and is registered with the European Clinical Trials Database , number 2005-005275-15 , and with ClinicalTrials.gov , number NCT00556374 .
RESULTS	Between Dec 18 , 2006 , and July 22 , 2013 , 3425 eligible patients were enrolled into the trial , of whom 3420 were randomly assigned to receive denosumab 60 mg ( n = 1711 ) or placebo ( n = 1709 ) subcutaneously every 6 months .
RESULTS	Compared with the placebo group , patients in the denosumab group had a significantly delayed time to first clinical fracture ( hazard ratio [ HR ] 050 [ 95 % CI 039-065 ] , p < 00001 ) .
RESULTS	The overall lower number of fractures in the denosumab group ( 92 ) than in the placebo group ( 176 ) was similar in all patient subgroups , including in patients with a bone mineral density T-score of -1 or higher at baseline ( n = 1872 , HR 044 [ 95 % CI 031-064 ] , p < 00001 ) and in those with a bone mineral density T-score of less than -1 already at baseline ( n = 1548 , HR 057 [ 95 % CI 040-082 ] , p = 0002 ) .
RESULTS	The patient incidence of adverse events in the safety analysis set ( all patients who received at least one dose of study drug ) did not differ between the denosumab group ( 1366 events , 80 % ) and the placebo group ( 1334 events , 79 % ) , nor did the numbers of serious adverse events ( 521 vs 511 [ 30 % in each group ] ) .
RESULTS	The main adverse events were arthralgia and other aromatase-inhibitor related symptoms ; no additional toxicity from the study drug was reported .
RESULTS	Despite proactive adjudication of every potential osteonecrosis of the jaw by an international expert panel , no cases of osteonecrosis of the jaw were reported .
RESULTS	93 patients ( 3 % of the full analysis set ) died during the study , of which one death ( in the denosumab group ) was thought to be related to the study drug .
CONCLUSIONS	Adjuvant denosumab 60 mg twice per year reduces the risk of clinical fractures in postmenopausal women with breast cancer receiving aromatase inhibitors , and can be administered without added toxicity .
CONCLUSIONS	Since a main side-effect of adjuvant breast cancer treatment can be substantially reduced by the addition of denosumab , this treatment should be considered for clinical practice .
BACKGROUND	Amgen .

###24930044
BACKGROUND	Fractalkine ( CX3CL1 ) is a chemokine associated with atherosclerosis and inflammation .
BACKGROUND	There is limited knowledge of fractalkine levels during acute myocardial infarction ( AMI ) and stem cell treatment .
BACKGROUND	We aimed to investigate the time profile of circulating fractalkine and gene expression of its receptor CX3CR1 during AMI , and the influence of intracoronary autologous bone marrow stem cell ( mBMC ) transplantation ( given 6 days after AMI ) on fractalkine levels .
METHODS	We examined fractalkine levels at different time points by enzyme-linked immunosorbent assay ( ELISA ) in 20 patients with AMI , and 10 patients with stable angina pectoris ( AP ) undergoing percutaneous coronary intervention ( PCI ) , and in 100 patients included in the randomized Autologous Stem-Cell Transplantation in Acute Myocardial Infarction ( ASTAMI ) trial .
RESULTS	Patients with AMI had significantly elevated levels 3 - and 12 h after PCI compared to patients with stable AP .
RESULTS	After 12 h levels were similar in the two groups .
RESULTS	An inverse pattern was observed in gene expression levels .
RESULTS	No correlation between fractalkine levels and myocardial injury or infarct size was seen .
RESULTS	We could not demonstrate any influence of autologous mBMC transplantation on fractalkine levels .
CONCLUSIONS	Fractalkine levels are elevated the first 12 h after PCI in patients with AMI , however , not correlated to infarct size .
CONCLUSIONS	The inverse pattern in gene expression of fractalkine receptor ( CX3CR1 ) might be a compensatory mechanism .
CONCLUSIONS	No effect of autologous mBMC transplantation given 6 days after AMI on fractalkine levels was observed .

###24859367
BACKGROUND	This prospective comparative study was done to evaluate the effectiveness of implants of different design ( titanium elastic intramedullary nail versus anatomical precontoured dynamic compression plate ) in treatment of displaced midshaft clavicular fractures .
METHODS	Sixty-six patients between 18 and 65years of age were included in this study .
METHODS	They were randomized in two groups to be treated with either elastic intramedullary nail ( EIN ) or plate .
METHODS	Clinical and radiological assessments were performed at regular intervals .
METHODS	Outcomes and complications of both groups over 2years of follow-up time were compared .
RESULTS	Length of incision , operation time , blood loss and duration of hospital stay were significantly less for the EIN group .
RESULTS	American Shoulder and Elbow Surgeons ( ASES ) and Constant Shoulder scores were significantly higher ( p < 0.05 ) in the plating group than the EIN group for the first 2months but there was no significant difference found between the two groups regarding functional and radiological outcome at the 2-year follow-up .
RESULTS	Significantly higher rates of refracture after implant removal ( p = 0.045 ) in the plating group was observed .
RESULTS	Infection and revision surgery rates were also higher in the plate group , but this difference was insignificant ( p > 0.05 ) .
CONCLUSIONS	EIN is a safe , minimally invasive surgical technique with a lower complication rate , faster return to daily activities , excellent cosmetic and comparable functional results , and can be used as an equally effective alternative to plate fixation in displaced midshaft clavicle fractures .
METHODS	Level 2 .

###24881463
BACKGROUND	Adjuvant therapy with an aromatase inhibitor improves outcomes , as compared with tamoxifen , in postmenopausal women with hormone-receptor-positive breast cancer .
METHODS	In two phase 3 trials , we randomly assigned premenopausal women with hormone-receptor-positive early breast cancer to the aromatase inhibitor exemestane plus ovarian suppression or tamoxifen plus ovarian suppression for a period of 5 years .
METHODS	Suppression of ovarian estrogen production was achieved with the use of the gonadotropin-releasing-hormone agonist triptorelin , oophorectomy , or ovarian irradiation .
METHODS	The primary analysis combined data from 4690 patients in the two trials .
RESULTS	After a median follow-up of 68 months , disease-free survival at 5 years was 91.1 % in the exemestane-ovarian suppression group and 87.3 % in the tamoxifen-ovarian suppression group ( hazard ratio for disease recurrence , second invasive cancer , or death , 0.72 ; 95 % confidence interval [ CI ] , 0.60 to 0.85 ; P < 0.001 ) .
RESULTS	The rate of freedom from breast cancer at 5 years was 92.8 % in the exemestane-ovarian suppression group , as compared with 88.8 % in the tamoxifen-ovarian suppression group ( hazard ratio for recurrence , 0.66 ; 95 % CI , 0.55 to 0.80 ; P < 0.001 ) .
RESULTS	With 194 deaths ( 4.1 % of the patients ) , overall survival did not differ significantly between the two groups ( hazard ratio for death in the exemestane-ovarian suppression group , 1.14 ; 95 % CI , 0.86 to 1.51 ; P = 0.37 ) .
RESULTS	Selected adverse events of grade 3 or 4 were reported for 30.6 % of the patients in the exemestane-ovarian suppression group and 29.4 % of those in the tamoxifen-ovarian suppression group , with profiles similar to those for postmenopausal women .
CONCLUSIONS	In premenopausal women with hormone-receptor-positive early breast cancer , adjuvant treatment with exemestane plus ovarian suppression , as compared with tamoxifen plus ovarian suppression , significantly reduced recurrence .
CONCLUSIONS	( Funded by Pfizer and others ; TEXT and SOFT ClinicalTrials.gov numbers , NCT00066703 and NCT00066690 , respectively . )

###24561972
BACKGROUND	urgent development of effective interventions to prevent rapidly rising childhood obesity in China is needed .
METHODS	Between May 2010 and December 2013 , a cluster randomized controlled trial was conducted among 4th graders in eight urban primary schools randomly assigned to intervention or control groups in Nanjing , China .
METHODS	A multi-component intervention program was implemented within the treatment group , while students in the control group followed their usual health education curriculum without additional intervention .
RESULTS	At baseline , 638 and 544 students were enrolled in the intervention and control group , respectively .
RESULTS	The prevalence of excess body weight was 26.8 % , with 27.4 % in the intervention group and 26.1 % in the control group ( p = 0.61 ) .
RESULTS	The mean ( SD ) BMI and WC was 18.7 ( 3.0 ) and 63.0 ( 9.2 ) for participants in intervention schools , and 18.5 ( 2.9 ) and 63.6 ( 8.7 ) for students in control group , separately ( p = 0.24 and 0.41 , respectively ) .
RESULTS	Compared to those who were not aware of what lifestyle/behavior factors were unhealthy , students who were aware of the unhealthy lifestyle / behavior factors consumed fewer fried snacks ( 0.460.76 serves/week vs 0.650.91 serves/week ; p < 0.01 ) , soft drinks ( 160194 ml/week vs 199227 ml/week ; p < 0.01 ) , but larger amount of meat ( 502429 g/week vs 449344 g/week ; p = 0.03 ) , and reported less screen time ( 214232 minutes/week vs 252264 minutes/week ; p < 0.01 ) .
RESULTS	Moreover , there was no difference within physical activity time between these two groups ( 257341 minutes/week vs 218324 minutes/week ; p = 0.13 ) .
CONCLUSIONS	Main characteristics of participants were balanced at baseline within intervention and control schools , but a gap existed between healthy lifestyle knowledge and actual healthy behavior in students .
BACKGROUND	ChiCTR-ERC-11001819 .

###24670126
OBJECTIVE	To explore experiences of mild-stroke survivors in the context of early supported discharge .
OBJECTIVE	The meanings patients attributed to activities and participation in the home recovery process were our main interest .
METHODS	Eight participants ( 45-80 years ) from a randomised controlled study were selected for this sub-study .
METHODS	This purposive sample had received rehabilitation in their homes in the post-stroke acute phase of recovery as part of the larger study .
METHODS	Extensive interview data were analysed using an interpretive strategy and systematic text condensation .
METHODS	Coping theory was included in later stages of analysis .
RESULTS	The mild-stroke survivors ' stories revealed that life had changed profoundly .
RESULTS	Differences and similarities in experienced changes were related to : self-perceived health , the body , practical activities , taking part in society , and self-perception .
RESULTS	The findings showed the ways in which life changed for mild-stroke survivors , experienced challenges , and survivors ' thoughts about the future .
CONCLUSIONS	Mild-stroke rehabilitation should focus more strongly on basic concerns related to self-perceived health , self-perception , and body , since these dimensions seem to complicate daily activities and close relationships .
CONCLUSIONS	Professionals should also be aware of patients who experience an uncertain situation and unresolved rehabilitation needs , which still can be present 6-8 months after the stroke .
CONCLUSIONS	When living with mild stroke , entrance to practical and social activities seemed founded on the patients ' perception of the body and self as comprehensible or not .
CONCLUSIONS	Comprehending their own changed body and sense of self seem to be a long-term process when living with mild stroke .
CONCLUSIONS	It is suggested that long-term follow-up be incorporated in home rehabilitation service , also in the context of early supported discharge .
CONCLUSIONS	This may contribute to help patient cope more optimally with activities and participation of importance to them .

###25155146
OBJECTIVE	To show that albiglutide , a glucagon-like peptide-1 receptor agonist , is an effective and generally safe treatment to improve glycaemic control in patients with type 2 diabetes mellitus whose hyperglycaemia is inadequately controlled with pioglitazone ( with or without metformin ) .
METHODS	In this 3-year , randomized , double-blind , placebo-controlled study , 310 adult patients on a regimen of pioglitazone ( with or without metformin ) were randomly assigned to receive additional treatment with albiglutide [ 30 mg subcutaneous ( s.c. ) once weekly , n = 155 ] or matching placebo ( n = 155 ) .
METHODS	The primary efficacy endpoint was change from baseline to week 52 ( intention-to-treat ) in glycated haemoglobin ( HbA1c ) .
RESULTS	The model-adjusted change from baseline in HbA1c at week 52 was significantly better with albiglutide than with placebo ( -0.8 % , 95 % confidence interval -1.0 , -0.6 ; p < 0.0001 ) .
RESULTS	Change from baseline fasting plasma glucose was -1.3 mmol/l in the albiglutide group and +0.4 mmol/l in the placebo group ( p < 0.0001 ) ; a significantly higher percentage of patients reached the HbA1c goals with albiglutide ( p < 0.0001 ) , and the rate of hyperglycaemia rescue up to week 52 for albiglutide was 24.4 versus 47.7 % for placebo ( p < 0.0001 ) .
RESULTS	Albiglutide plus pioglitazone had no impact on weight , and severe hypoglycaemia was observed rarely ( n = 2 ) .
RESULTS	With few exceptions , the results of safety assessments were similar between the groups , and most adverse events ( AEs ) were mild or moderate .
RESULTS	The 52-week incidence rates for gastrointestinal AEs for albiglutide and placebo were : 31.3 and 29.8 % , respectively ( diarrhoea : 11.3 and 8.6 % ; nausea : 10.7 and 11.3 % ; vomiting : 4.0 and 4.0 % ) .
CONCLUSIONS	Albiglutide 30 mg administered once weekly as an add-on to pioglitazone ( with or without metformin ) provided effective and durable glucose lowering and was generally well tolerated .

###25028177
OBJECTIVE	The recently published SARA study was a prospective , multi-centre randomized controlled trial that compared CA to antiarrhythmic drug therapy ( ADT ) in 146 patients with persistent atrial fibrillation ( AF ) .
OBJECTIVE	The study found that recurrence of AF or atrial flutter occurred significantly less often in the CA arm compared to the ADT arm ( 29.6 % vs. 56.3 % , p = 0.002 ) .
OBJECTIVE	Despite this clear superiority in terms of efficacy , the authors were not able to demonstrate a corresponding Quality of Life ( QoL ) improvement .
OBJECTIVE	We sought to investigate this apparent disparity using alternative analytical methods .
RESULTS	We were able to show that a high coefficient of variation existed for all QoL measures at each time point which may explain the lack of statistical difference originally reported .
RESULTS	We reanalyzed the raw QoL data from the SARA study using paired sample t-tests for the change in QOL for individual patients between baseline and 12 month ( final ) follow up .
RESULTS	For patients randomized to ADT the difference in QoL after 12 months was not significant for any of the four QoL domains ( global , physical , psychological and sexual ) whereas for patients randomized to CA all comparisons were significant ( global , p < 0.001 ; physical , p = 0.001 ; psychological , p < 0.001 ; sexual , p = 0.003 ) .
CONCLUSIONS	In the SARA study , after 12 months ' follow up , CA significantly improved QoL for patients with persistent AF whereas medical therapy had no appreciable effect .

###24752130
OBJECTIVE	The aim of this study was to investigate the influence on fertility and pregnancy outcome in cervical intraepithelial neoplasia ( CIN ) patients after a loop electrosurgical excision procedure ( LEEP ) or cold-knife conization ( CKC ) .
METHODS	269 patients with CIN-II-III who wanted to conceive were prospectively enrolled in this randomized clinical trial to receive either the LEEP or CKC procedure .
METHODS	Fertility , neonatal and maternal outcomes were observed and compared .
RESULTS	244 evaluable patients were divided into two groups .
RESULTS	There were 124 in the LEEP group and 120 in the CKC group .
RESULTS	The preterm premature rupture of membranes ( 16 vs. 8 % ; p = 0.03 ) , preterm delivery rate ( 11 vs. 5 % ; p = 0.04 ) and low birth weight infants rate ( < 2,500 g ) ( 10 vs. 6 % ; p = 0.04 ) were higher in the CKC group than in the LEEP group , but there was no difference in mean birth weight , cesarean delivery , labor induction , or neonatal intensive care unit admission .
RESULTS	There was no case of neonatal mortality .
CONCLUSIONS	In a prospective evaluation the findings of this study demonstrate that LEEP is safer for future pregnancies when compared to CKC .
CONCLUSIONS	LEEP should be an appropriate choice for patients with CIN who want to become pregnant later in life .

###25406897
BACKGROUND	Current neonatal resuscitation guidelines recommend tracheal suctioning of nonvigorous neonates born through meconium-stained amniotic fluid .
METHODS	We evaluated the effect of tracheal suctioning at birth in 29 lambs with asphyxia induced by cord occlusion and meconium aspiration during gasping .
RESULTS	Tracheal suctioning at birth ( n = 15 ) decreased amount of meconium in distal airways ( 53 29 particles/mm ( 2 ) lung area ) compared to no suction ( 499 109 particles/mm ( 2 ) ; n = 14 ; P < 0.001 ) .
RESULTS	Three lambs in the suction group had cardiac arrest during suctioning , requiring chest compressions and epinephrine .
RESULTS	Onset of ventilation was delayed in the suction group ( 146 11 vs. 47 3 s in no-suction group ; P = 0.005 ) .
RESULTS	There was no difference in pulmonary blood flow , carotid blood flow , and pulmonary or systemic blood pressure between the two groups .
RESULTS	Left atrial pressure was significantly higher in the suction group .
RESULTS	Tracheal suctioning resulted in higher Pao2/FiO2 levels ( 122 21 vs. 78 10 mm Hg ) and ventilator efficiency index ( 0.3 0.05 vs. 0.16 0.03 ) .
RESULTS	Two lambs in the no-suction group required inhaled nitric oxide .
RESULTS	Lung 3-nitrotyrosine levels were higher in the suction group ( 0.65 0.03 ng/g protein ) compared with the no-suction group ( 0.47 0.06 ) .
CONCLUSIONS	Tracheal suctioning improves oxygenation and ventilation .
CONCLUSIONS	Suctioning does not improve pulmonary/systemic hemodynamics or oxidative stress in an ovine model of acute meconium aspiration with asphyxia .

###25072444
OBJECTIVE	A randomized controlled trial was conducted to find out whether antiviral therapy in patients with hepatitis B-related hepatocellular carcinoma ( HCC ) improves long-term survival after hepatic resection .
BACKGROUND	Despite advances in surgery and in multidisciplinary treatment , there is still no effective adjuvant treatment to prevent HCC recurrence after R0 resection for HCC .
BACKGROUND	Whether antiviral therapy is useful in reducing postoperative HCC recurrence is unclear .
METHODS	Between May 2007 and April 2008 , patients who received R0 hepatic resection for HBV-related HCC were randomly assigned to receive no treatment ( the control group , n = 100 ) or antiviral therapy ( adefovir 10 mg/d , the antiviral group , n = 100 ) .
RESULTS	The baseline clinical , laboratory , and tumor characteristics of the 2 groups were comparable .
RESULTS	The 1 - , 3 - , and 5-year recurrence-free survival rates for the antiviral group and the control group were 85.0 % , 50.3 % , 46.1 % and 84.0 % , 37.9 % , 27.1 % , respectively .
RESULTS	The corresponding overall survival rates for the 2 groups were 96.0 % , 77.6 % , 63.1 % and 94.0 % , 67.4 % , 41.5 % , respectively .
RESULTS	The recurrence-free survival and overall survival for the antiviral group were significantly better than the control group ( P = 0.026 , P = 0.001 ) .
RESULTS	After adjusting for the confounding prognostic factors in a Cox model , the relative risks of recurrence and death for antiviral treatment were 0.651 [ 95 % confidence interval ( CI ) : 0.451-0 .938 ; P = 0.021 ] and 0.420 ( 95 % CI : 0.271-0 .651 ; P < 0.001 ) .
RESULTS	Antiviral therapy was an independent protective factor of late tumor recurrence ( HR = 0.348 , 95 % CI : 0.177-0 .687 ; P = 0.002 ) but not of early tumor recurrence [ hazard ratio ( HR ) = 0.949 , 95 % CI : 0.617-1 .459 ; P = 0.810 ] .
CONCLUSIONS	In patients with hepatitis B-related HCC , adefovir antiviral therapy reduced late HCC recurrence and significantly improved overall survival after R0 hepatic resection .

###24434303
BACKGROUND	The effectiveness of simulation is rarely evaluated .
BACKGROUND	The aim of this study was to assess the impact of a short training course on the ability of anesthesiology residents to comply with current difficult airway management guidelines .
METHODS	Twenty-seven third-year anesthesiology residents were assessed on a simulator in a `` ca n't intubate , ca n't ventilate '' scenario before the training ( the pretest ) and then randomly 3 , 6 , or 12 months after training ( the posttest ) .
METHODS	The scenario was built so that the resident was prompted to perform a cricothyrotomy .
METHODS	Compliance with airway management guidelines and the cricothyrotomy 's duration and technical quality were assessed as a checklist score [ 0 to 10 ] and a global rating scale [ 7 to 35 ] .
RESULTS	After training , all 27 residents ( 100 % ) complied with the airway management guidelines , compared with 17 ( 63 % ) in the pretest ( P < 0.005 ) .
RESULTS	In the pretest and the 3 - , 6 - , and 12-month posttests , the median [ range ] duration of cricothyrotomy was respectively 117 s [ 70 to 184 ] , 69 s [ 43 to 97 ] , 52 s [ 43 to 76 ] , and 62 s [ 43 to 74 ] ( P < 0.0001 vs. in the pretest ) , the median [ range ] checklist score was 3 [ 0 to 7 ] , 10 [ 8 to 10 ] , 9 [ 6 to 10 ] , and 9 [ 4 to 10 ] ( P < 0.0001 vs. in the pretest ) and the median [ range ] global rating scale was 12 [ 7 to 22 ] , 30 [ 20 to 35 ] , 33 [ 23 to 35 ] , and 31 [ 18 to 33 ] ( P < 0.0001 vs. in the pretest ) .
RESULTS	There were no significant differences between performance levels achieved in the 3 - , 6 - , and 12-month posttests .
CONCLUSIONS	The training session significantly improved the residents ' compliance with guidelines and their performance of cricothyrotomy .

###25241364
OBJECTIVE	To study the impact of administration of dydrogesterone in early pregnancy on pregnancy outcome and its correlation with Th1 and Th2 cytokine levels .
METHODS	Double-blind , randomized , placebo-controlled study .
METHODS	A medical college and its associated hospital .
METHODS	Women with either : [ 1 ] a history of idiopathic recurrent pregnancy loss ( RPL ) , in either a dydrogesterone group or a placebo group , or [ 2 ] no history of miscarriage .
METHODS	Dydrogesterone 20 mg/day from confirmation of pregnancy to 20 weeks of gestation .
METHODS	Occurrence of another pregnancy loss and concentrations of T-helper ( Th ) 1 ( interferon - and tumor necrosis factor - ) and Th2 ( interleukin ( IL ) -4 and IL-10 ) cytokines in serum at recruitment ( 4-8 weeks of gestation ) and at abortion or 20 weeks of gestation , using commercially available ELISA kits .
RESULTS	Occurrence of another abortion after 3 consecutive abortions was significantly higher ( 29 of 173 ; 16.76 % ) in women with RPL compared with healthy pregnant controls ( 6 of 174 ; 3.45 % ) .
RESULTS	Risk of occurrence of miscarriage after 3 abortions was 2.4 times higher in the placebo group vs. the treatment group ( risk ratio = 2.4 , 95 % CI = 1.3-5 .9 ) .
RESULTS	Mean gestational age at delivery ( excluding those aborted before 20 weeks of gestation ) increased significantly in the dydrogesterone group ( 38.011.96 weeks ) compared with the placebo group ( 37.232.41 weeks ) .
RESULTS	Baby weight was significantly lower in the placebo group ( 2421.4321.6 g ) compared with the healthy pregnant controls ( 2545.3554.3 g ) .
RESULTS	At recruitment , serum IL-4 and tumor necrosis factor - levels were significantly lower in the RPL group compared with the healthy pregnant controls .
RESULTS	However , serum interferon - level was significantly higher in the RPL group ( 8.870.72 pg/mL ) compared with the healthy pregnant controls ( 8.081.27 pg/mL ) .
CONCLUSIONS	The present study supports the use of dydrogesterone in women with recurrent abortions to improve pregnancy outcome , such as a reduction in abortions and improved gestational age and baby weight at delivery .
CONCLUSIONS	However , these outcomes were not modulated by Th1 and Th2 cytokine production .
BACKGROUND	CTRI/2010/091 / 000373 .

###25299799
OBJECTIVE	The aim of this study was to evaluate the feasibility of low-concentration iso-osmolar Iodixanol 270 compared with Iohexol 350 in patients with coronary artery bypass grafts ( CABGs ) undergoing coronary computed tomographic angiography ( CCTA ) .
METHODS	A total of 80 consecutive patients undergoing CABG follow-up with the use of CCTA were prospectively enrolled , with 40 patients assigned to Iodixanol 270 and 40 patients assigned to Iohexol 350 .
METHODS	In both groups , the contrast medium was injected at an injection rate of 4.5 mL/s in the patients with a body mass index of greater than 24 kg/m2 and 3.5 mL/s in the patients with a body mass index of 24 kg/m2 or lower .
METHODS	The contrast volume was determined by the flow rate and scan time .
METHODS	Image quality score and visualization of bypass grafts were evaluated .
METHODS	Subjective assessment of image quality for each coronary artery segment was determined using a 4-point grading scale by 2 reviewers , whereas objective evaluation of image quality was conducted by measuring the mean CT attenuation values ( hounsfield unit [ HU ] ) in terms of SD , contrast-noise ratio , and signal-noise ratio in the ascending aorta .
RESULTS	The mean ( SD ) contrast volume for the Iodixanol 270 and Iohexol 350 groups was 66.28 ( 12.00 ) and 64.98 ( 8.12 ) mL , respectively , with no significant difference ( P = 0.57 ) .
RESULTS	The mean ( SD ) CT attenuation value in the Iodixanol 270 group was 414.72 ( 101.47 ) , which was lower than in the Iohexol 350 group , which was 478.85 ( 108.73 ) ( P = 0.01 ) .
RESULTS	The subjective image quality for the Iodixanol 270 group was superior to that for the Iohexol 350 group in the arterial graft vessels ( P = 0.027 ) , whereas there was no significant difference between the 2 groups in the venous graft vessels ( P = 0.377 ) .
RESULTS	There was no significant difference in terms of SD of the ascending aorta , signal-noise ratio , and contrast-noise ratio between the 2 groups .
CONCLUSIONS	Low-concentration iso-osmolar Iodixanol 270 provides image quality comparable with that of Iohexol 350 , allowing diagnostic CCTA follow-up of patients with CABGs .

###24657122
OBJECTIVE	To evaluate the tolerability and immunogenicity of a booster dose of the quadrivalent meningococcal conjugate vaccine MenACWY-CRM ( Menveo , Novartis Vaccines and Diagnostics , Siena , Italy ) administered 3years after primary vaccination of adolescents enrolled in a phase 3 study with either MenACWY-CRM or MenACWY-D ( Menactra , Sanofi Pasteur , Swiftwater , Pennsylvania ) .
METHODS	A total of 730 healthy adolescents participated , including 622 initial study participants who received primary vaccination with MenACWY-CRM ( n = 367 ) or MenACWY-D ( n = 255 ) 3years previously and 108 age-matched vaccine-nave controls .
METHODS	A subset of MenACWY-CRM ( n = 83 ) and MenACWY-D ( n = 77 ) recipients were administered a MenACWY-CRM booster dose 3years postprimary vaccination .
METHODS	Immunogenicity prior to and after the booster dose of MenACWY-CRM was measured by serum bactericidal assay with human complement ( hSBA ) .
METHODS	Local and systemic reactions and adverse events were monitored in subjects receiving the booster dose .
RESULTS	At 3years postprimary vaccination , 64 % , 82 % , and 65 % of subjects initially vaccinated with MenACWY-CRM ( n = 367 ) showed hSBA titers 8 against serogroups C , W-135 , and Y , respectively ; this was lower for serogroup A ( 28 % ) .
RESULTS	Significantly more MenACWY-CRM recipients had hSBA titers 8 for serogroups W-135 and Y than MenACWY-D recipients ( n = 255 ) .
RESULTS	A MenACWY-CRM booster dose resulted in 99 % -100 % of subjects demonstrating hSBA titers 8 against all serogroups , irrespective of primary vaccination ( MenACWY-CRM , n = 83 ; MenACWY-D , n = 77 ) .
RESULTS	The booster dose was well tolerated without significant adverse events .
CONCLUSIONS	MenACWY-CRM can be used to boost adolescents who have received a primary vaccination with either MenACWY-CRM or MenACWY-D .

###25088030
BACKGROUND	The effectiveness of clinic-based pulmonary rehabilitation in advanced COPD is well established , but few data exist for less severe patients treated in alternative settings .
BACKGROUND	The purpose of this study was to investigate whether a novel , community-based exercise program ( CBE ) was feasible and effective for patients with moderate COPD .
METHODS	Nineteen patients with moderate COPD ( mean FEV1 62 % ) and self-reported exercise impairment were randomized to 12-weeks of progressive endurance and strength training at a local health club under the guidance of a certified personal trainer , or to continuation of unsupervised habitual physical activity .
METHODS	Outcomes assessed at baseline and 12 weeks included session compliance , intensity adherence , treadmill endurance time , muscle strength , dyspnea , and health status .
RESULTS	Compliance was 94 % and adherence was 83 % .
RESULTS	Comparisons between CBE and control groups yielded the following mean ( SEM ) differences in favor of CBE : endurance time 134 ( 74 ) seconds versus -59 ( 49 ) seconds ( P = 0.041 ) and TDI 5.1 ( 0.8 ) versus -0.2 ( 0.5 ) ( P < 0.001 ) .
RESULTS	The CBE group increased muscle strength ( weight lifted ) by 11.8 kilograms per subject per week of training ( P < 0.001 ) .
RESULTS	SGRQ was not significantly changed .
CONCLUSIONS	We demonstrated the feasibility and effectiveness of a novel community-based exercise program involving health clubs and personal trainers for patients with moderate COPD .
BACKGROUND	ClinicalTrials.gov Identifier NCT01985529 .

###25671798
BACKGROUND	Among patients with a proximal vessel occlusion in the anterior circulation , 60 to 80 % of patients die within 90 days after stroke onset or do not regain functional independence despite alteplase treatment .
BACKGROUND	We evaluated rapid endovascular treatment in addition to standard care in patients with acute ischemic stroke with a small infarct core , a proximal intracranial arterial occlusion , and moderate-to-good collateral circulation .
METHODS	We randomly assigned participants to receive standard care ( control group ) or standard care plus endovascular treatment with the use of available thrombectomy devices ( intervention group ) .
METHODS	Patients with a proximal intracranial occlusion in the anterior circulation were included up to 12 hours after symptom onset .
METHODS	Patients with a large infarct core or poor collateral circulation on computed tomography ( CT ) and CT angiography were excluded .
METHODS	Workflow times were measured against predetermined targets .
METHODS	The primary outcome was the score on the modified Rankin scale ( range , 0 [ no symptoms ] to 6 [ death ] ) at 90 days .
METHODS	A proportional odds model was used to calculate the common odds ratio as a measure of the likelihood that the intervention would lead to lower scores on the modified Rankin scale than would control care ( shift analysis ) .
RESULTS	The trial was stopped early because of efficacy .
RESULTS	At 22 centers worldwide , 316 participants were enrolled , of whom 238 received intravenous alteplase ( 120 in the intervention group and 118 in the control group ) .
RESULTS	In the intervention group , the median time from study CT of the head to first reperfusion was 84 minutes .
RESULTS	The rate of functional independence ( 90-day modified Rankin score of 0 to 2 ) was increased with the intervention ( 53.0 % , vs. 29.3 % in the control group ; P < 0.001 ) .
RESULTS	The primary outcome favored the intervention ( common odds ratio , 2.6 ; 95 % confidence interval , 1.7 to 3.8 ; P < 0.001 ) , and the intervention was associated with reduced mortality ( 10.4 % , vs. 19.0 % in the control group ; P = 0.04 ) .
RESULTS	Symptomatic intracerebral hemorrhage occurred in 3.6 % of participants in intervention group and 2.7 % of participants in control group ( P = 0.75 ) .
CONCLUSIONS	Among patients with acute ischemic stroke with a proximal vessel occlusion , a small infarct core , and moderate-to-good collateral circulation , rapid endovascular treatment improved functional outcomes and reduced mortality .
CONCLUSIONS	( Funded by Covidien and others ; ESCAPE ClinicalTrials.gov number , NCT01778335 . )

###25218539
OBJECTIVE	Infants and children who undergo cardiopulmonary bypass and cardiac surgery are at risk of postoperative fluid overload .
OBJECTIVE	Peritoneal dialysis catheter ( PDC ) and peritoneal dialysis are reported to be effective means of postoperative fluid management .
OBJECTIVE	We sought to test the hypothesis that PDC insertion in the operating room at the time of Norwood palliation would decrease the time to achieve a negative fluid balance in a group of neonates with hypoplastic left heart syndrome .
METHODS	A single center randomized controlled trial was performed .
METHODS	We randomized neonates with hypoplastic left heart syndrome to prophylactic PDC , with or without dialysis , or standard care ( ie , no PDC ) .
RESULTS	Twenty-two neonates were included ; 10 were randomized to PDC and 12 were randomized to standard care .
RESULTS	The mean time to first postoperative negative fluid balance was 2.70 1.06 days for the prophylactic PDC group and 2.67 0.65 days for the standard care group ( P = .93 ) .
RESULTS	There was no difference between the 2 groups in time to lactate 2 mmol/L , maximum vasoactive-inotrope score on postoperative days 2 to 5 , time to sternal closure , time to first extubation , modified clinical outcome score , or hospital length of stay .
RESULTS	Twenty-one patients ( 95 % ) survived to hospital discharge .
RESULTS	Four patients randomized to prophylactic PDC had 1 or more serious adverse events compared with no patients in the standard care group ( P = .03 ) .
CONCLUSIONS	Prophylactic PDC , with or without dialysis , did not decrease the time to achieve a negative fluid balance after the Norwood procedure , did not alter physiological variables postoperatively , and was associated with more severe adverse events .

###24762094
OBJECTIVE	AWARD-5 was an adaptive , seamless , double-blind study comparing dulaglutide , a once-weekly glucagon-like peptide-1 ( GLP-1 ) receptor agonist , with placebo at 26weeks and sitagliptin up to 104weeks .
OBJECTIVE	The study also included a dose-finding portion whose results are presented here .
METHODS	Type 2 diabetes ( T2D ) patients on metformin were randomized 3:1:1 to seven dulaglutide doses , sitagliptin ( 100mg ) , or placebo .
METHODS	A Bayesian algorithm was used for randomization and dose selection .
METHODS	Patients were adaptively randomized to dulaglutide doses using available data on the basis of a clinical utility index ( CUI ) of glycosylated haemoglobin A1c ( HbA1c ) versus sitagliptin at 52weeks and weight , pulse rate ( PR ) and diastolic blood pressure ( DBP ) versus placebo at 26weeks .
METHODS	The algorithm randomly assigned patients until two doses were selected .
RESULTS	Dulaglutide 1.5 mg was determined to be the optimal dose .
RESULTS	Dulaglutide 0.75 mg met criteria for the second dose .
RESULTS	Dulaglutide 1.5 mg showed the greatest Bayesian mean change from baseline ( 95 % credible interval ) in HbA1c versus sitagliptin at 52weeks -0.63 ( -0.98 to -0.20 ) % .
RESULTS	Dulaglutide 2.0 mg showed the greatest placebo-adjusted mean change in weight [ -1.99 ( -2.88 to -1.20 ) kg ] and in PR [ 0.78 ( -2.10 to 3.80 ) bpm ] .
RESULTS	Dulaglutide 1.5 mg showed the greatest placebo-adjusted mean change in DBP [ -0.62 ( -3.40 to 2.30 ) mmHg ] .
CONCLUSIONS	The Bayesian algorithm allowed for an efficient exploration of a large number of doses and selected dulaglutide doses of 1.5 and 0.75 mg for further investigation in this trial .

###24316697
OBJECTIVE	To evaluate the anti-inflammatory and analgesic effect of Bromelain ( pineapple extract ) administered orally in the postoperative after extraction of impacted lower molars .
METHODS	This is a prospective , placebo-controlled , unicentric , double-blind study ; the sample size was 34 patients .
METHODS	The pre and postoperative outcomes , evaluated on the third ( D3 ) and eighth day ( D8 ) , included inflamtion , pain and oral aperture , as well as the need for analgesics .
METHODS	One group received Bromelain 150mg per day for three days and 100mg on days 4 to 7 .
METHODS	The other group received placebo in the same dosage .
METHODS	All outcomes werrecorded quantitatively and analyzed with the Mann-Whitney U test for independent samples .
RESULTS	Although there were no statistically significant differences between the treatment groups , a trend towards less inflammation and improved oral aperture was observed in the group that received Bromelain , compared to the group that received placebo .
RESULTS	This trend can be attributed completely to random reasons , since there is no statistical difference in the results .
CONCLUSIONS	Further studies are necessary to analyze different administration patterns and doses of Bromelain for the use in the postoperative of impacted third molars .

###26164097
BACKGROUND	Cholera is endemic in Bangladesh with epidemics occurring each year .
BACKGROUND	The decision to use a cheap oral killed whole-cell cholera vaccine to control the disease depends on the feasibility and effectiveness of vaccination when delivered in a public health setting .
BACKGROUND	We therefore assessed the feasibility and protective effect of delivering such a vaccine through routine government services in urban Bangladesh and evaluated the benefit of adding behavioural interventions to encourage safe drinking water and hand washing to vaccination in this setting .
METHODS	We did this cluster-randomised open-label trial in Dhaka , Bangladesh .
METHODS	We randomly assigned 90 clusters ( 1:1:1 ) to vaccination only , vaccination and behavioural change , or no intervention .
METHODS	The primary outcome was overall protective effectiveness , assessed as the risk of severely dehydrating cholera during 2 years after vaccination for all individuals present at time of the second dose .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01339845 .
RESULTS	Of 268,896 people present at baseline , we analysed 267,270 : 94,675 assigned to vaccination only , 92,539 assigned to vaccination and behavioural change , and 80,056 assigned to non-intervention .
RESULTS	Vaccine coverage was 65 % in the vaccination only group and 66 % in the vaccination and behavioural change group .
RESULTS	Overall protective effectiveness was 37 % ( 95 % CI lower bound 18 % ; p = 0002 ) in the vaccination group and 45 % ( 95 % CI lower bound 24 % ; p = 0001 ) in the vaccination and behavioural change group .
RESULTS	We recorded no vaccine-related serious adverse events .
CONCLUSIONS	Our findings provide the first indication of the effect of delivering an oral killed whole-cell cholera vaccine to poor urban populations with endemic cholera using routine government services and will help policy makers to formulate vaccination strategies to reduce the burden of severely dehydrating cholera in such populations .
BACKGROUND	Bill & Melinda Gates Foundation .

###25461966
BACKGROUND	The purpose of the study was to evaluate the efficacy of antimicrobial photodynamic therapy ( aPDT ) used as an adjunct to the endodontic re-treatment in the eradication of microorganisms from previously filled root canals .
METHODS	The study sample consisted of 21 randomly selected patients with root filled and infected root canal system with chronic apical periodontitis on incisors or canines , who have had previously endodontic treatment .
METHODS	Microbiological samples from the root canals were collected after accessing the canal , following the endodontic re-treatment and after the aPDT procedure .
METHODS	During instrumentation , the root canals were irrigated with 2.5 % sodium hypochlorite ( NaOCl ) , and the final irrigation protocol included 17 % ethylenediaminetetraacetic acid followed by NaOCl .
METHODS	Root canals were filled with a phenothiazinium chloride and irradiated with a diode laser ( = 660 nm , 100 mW ) for 1 min .
METHODS	Microbiological samples from the root canals were cultivated on selective plates , and the identification was done by micromorphology , macromorphology and different API strips as well as bacterial counts ( colony forming units ) .
RESULTS	Fourteen bacteria species were isolated from the root canals initially , with a mean value of 4.57 species per canal .
RESULTS	Although endodontic re-treatment alone produced a significant reduction in the number of bacteria species ( p < 0.001 ) , the combination of endodontic treatment and aPDT was statistically more effective ( p < 0.001 ) .
RESULTS	No bacteria were cultivated from the main root canals of 11 teeth .
CONCLUSIONS	The results indicated that the aPDT used as an adjunct to the conventional endodontic therapy achieved a significant further reduction of intracanal microbial load .

###24565296
OBJECTIVE	Regional anesthesia is a commonly used technique in orthopedic procedures .
OBJECTIVE	Sedation should reduce the patient 's anxiety and fear while increasing regional anesthesia quality .
OBJECTIVE	This study evaluated the hemodynamic changes , level of sedation , both patients ' and surgeons ' levels of satisfaction and potential side effects in patient-controlled sedation using propofol .
METHODS	This randomized clinical trial studied sixty ASA physical class I-III patients scheduled for total knee replacement surgery under combined spinal-epidural anesthesia .
METHODS	Patients in Group P ( n = 30 ) received propofol via a patient-controlled analgesia device with the following settings : intravenous propofol bolus dose 400 g.kg ( -1 ) , 5-minute lockout interval and no basal infusion .
METHODS	In Group S , we infused saline 150 using the same settings .
METHODS	To determine the level of sedation , we used BIS and Observer 's Assessment of Alertness/Sedation Scale .
METHODS	For all patients , we recorded the number of requests .
METHODS	As the final evaluation , we scored surgeons ' and patients ' satisfaction on 4-point scales .
RESULTS	Both BIS values and OAA/S scores were lower in Group P than in Group S. Patients ' satisfaction was higher in Group P , although there was no significant difference with respect to surgeons ' satisfaction between the groups .
RESULTS	The number of requests for sedation was significantly higher in Group S. However , most requests were considered unsuccessful .
CONCLUSIONS	This study suggests that patient-controlled sedation with propofol can be used efficiently in orthopedic procedures .

###24462855
OBJECTIVE	To evaluate outcomes relative to treatment using systemic methotrexate ( MTX ) alone or systemic MTX combined with ultrasound ( US ) - guided local injection of potassium chloride ( KCl ) or MTX in women with live tubal ectopic pregnancies .
METHODS	Case-control study ( Canadian Task Force classification II-2 ) .
METHODS	Departments of Obstetrics and Gynecology in 2 hospitals in China .
METHODS	Eighty-two women with live tubal ectopic pregnancies .
METHODS	Participants in the study received treatment using either systemic MTX ( n = 37 ; systemic treatment group ) or systemic MTX and US-guided local injection of either MTX or KCl ( n = 45 ; combined treatment group ) .
RESULTS	Patient clinical features and outcomes were compared .
RESULTS	There were no significant differences between the patient groups insofar as baseline gestational age , - human chorionic gonadotropin concentration , or size of conceptus .
RESULTS	The success rate in patients who received combined therapy ( 93.3 % ) was much higher than in those who received only systemic treatment ( 73.0 % ) ( p < .05 ) .
RESULTS	In the combined treatment group , the success rate was similar between women who received locally injected KCl ( 95.2 % ) and those who received locally injected MTX ( 91.7 % ) .
CONCLUSIONS	The significantly higher success rate in patients who received combined US-guided local injection and systemic MTX suggests that this is an efficient nonsurgical option in women with tubal pregnancy , high serum - human chorionic gonadotropin concentration , and fetal cardiac activity .

###24279686
OBJECTIVE	To determine whether an intervention that improves nursing home ( NH ) staff connections , communication , and problem solving ( CONNECT ) would improve implementation of a falls reduction education program ( FALLS ) .
METHODS	Cluster randomized trial .
METHODS	Community ( n = 4 ) and Veterans Affairs ( VA ) NHs ( n = 4 ) .
METHODS	Staff in any role with resident contact ( n = 497 ) .
METHODS	NHs received FALLS alone ( control ) or CONNECT followed by FALLS ( intervention ) , each delivered over 3 months .
METHODS	CONNECT used storytelling , relationship mapping , mentoring , self-monitoring , and feedback to help staff identify communication gaps and practice interaction strategies .
METHODS	FALLS included group training , modules , teleconferences , academic detailing , and audit and feedback .
METHODS	NH staff completed surveys about interactions at baseline , 3 months ( immediately after CONNECT or control period ) , and 6 months ( immediately after FALLS ) .
METHODS	A random sample of resident charts was abstracted for fall risk reduction documentation ( n = 651 ) .
METHODS	Change in facility fall rates was an exploratory outcome .
METHODS	Focus groups were conducted to explore changes in organizational learning .
RESULTS	Significant improvements in staff perceptions of communication quality , participation in decision-making , safety climate , caregiving quality , and use of local interaction strategies were observed in intervention community NHs ( treatment-by-time effect P = .01 ) but not in VA NHs , where a ceiling effect was observed .
RESULTS	Fall risk reduction documentation did not change significantly , and the direction of change in individual facilities did not relate to observed direction of change in fall rates .
RESULTS	Fall rates did not change in control facilities ( falls/bed per year : baseline , 2.61 ; after intervention , 2.64 ) but decreased by 12 % in intervention facilities ( falls/bed per year : baseline , 2.34 ; after intervention , 2.06 ) ; the effect of treatment on rate of change was 0.81 ( 95 % confidence interval = 0.55-1 .20 ) .
CONCLUSIONS	CONNECT has the potential to improve care delivery in NHs , but the trend toward improving fall rates requires confirmation in a larger ongoing study .

###25227833
OBJECTIVE	To explore the clinical efficacy of gemcitabine concomitant with nedaplatin and drug resistance in the treatment of non-small cell lung cancer ( NSCLC ) and associated molecular predicators .
METHODS	A total of 68 patients diagnosed with NSCLC by histology served as the study objects and were randomly divided into an observation group treated with gemcitabine concomitant with nedaplatin and a control group with cisplatin concomitant with gemcitabine , 34 cases for each group .
METHODS	Short-term and long-term efficacies , adverse responses as well as the expression of nucleotide excision repair cross complementing 1 ( ERCC1 ) , ribonucleotide reductase subunit M1 ( RRM1 ) and lung resistance-related protein ( LRP ) in NSCLC tissues in both groups were assessed .
RESULTS	The short-term objective response rate ( ORR ) and disease control rate ( DCR ) were 35.3 % ( 12/34 ) and 76.5 % ( 26/34 ) in the observation group and 38.2 % ( 13/34 ) and 85.3 % ( 29/34 ) in the control group , respectively , the differences not being statistically significant .
RESULTS	The time to progression ( TTP ) in both groups were 1 ~ 12 months , while the median TTP was 135 d and 144 d , respectively .
RESULTS	Though the survival was slightly higher in the control group , there were no significant differences in TTP and survival time .
RESULTS	The rates of decreased hemoglobin , vomiting and nausea as well as renal toxicity were evidently lower in the observation group , while other adverse responses demonstrated no significant difference .
RESULTS	The positive expression rates of ERCC1 , RRM1 and LRP were 47.1 % ( 16/34 ) , 61.8 % ( 21/34 ) and 64.7 % ( 22/34 ) in the observation group , respectively .
RESULTS	Compared with negative ERCC1 expression , ORR had decreasing trend and the overall survival time ( OS ) decreased significantly in patients with positive ERCC1 expression , which were markedly decreased by the positive expressions of RRM1 and LRP .
CONCLUSIONS	Gemcitabine concomitant with nedaplatin has significant effects in the treatment of NSCLC , with an adverse response rate obviously lower than for cisplatin concomitant with gemcitabine , suggesting that wider use in the clinic is warranted .
CONCLUSIONS	Additionally , the positive expressions of ERCC1 , RRM1 and LRP may increase patient drug resistance , so they can be applied as the chemotherapeutic predicators to guide individualized therapy of NSCLC patients .

###26043884
BACKGROUND	Early antiretroviral therapy ( ART ) and virological suppression can affect evolving antibody responses to HIV infection .
BACKGROUND	We aimed to assess frequency and predictors of seronegativity in infants starting early ART .
METHODS	We compared HIV antibody results between two of three treatment groups of the Children with HIV Early Antiretroviral Therapy ( CHER ) trial , done from July , 2005 , until July , 2011 , in which infants with HIV infection aged 57-120 weeks with a percentage of CD4-positive T lymphocytes of at least 25 % were randomly assigned to immediate ART for 96 weeks ( ART-96W ) or deferred ART until clinical or immunological progression ( ART-Def ) .
METHODS	We measured antibody from all available stored samples for ART-96W and ART-Def at trial week 84 using three assays : fourth-generation enzyme immunoassay HIV antigen-antibody combination , HIV-1 and HIV-2 rapid antibody test , and quantitative anti-gp120 IgG ELISA .
METHODS	We also assessed odds of seropositivity with respect to age of ART initiation and cumulative viral load .
METHODS	The CHER trial was registered with ClinicalTrials.gov , number NCT00102960 .
RESULTS	The median age of the infants from when samples were taken ( 184 samples from 268 infants ) was 92 weeks ( IQR 906-934 ) .
RESULTS	More specimens from the ART-96W group were seronegative than from the ART-Def group by enzyme immunoassay ( ART-96W 49 [ 46 % ] of 107 vs ART-Def eight [ 11 % ] of 75 ; p < 00001 ) and rapid antibody test ( 54 [ 53 % ] of 101 vs eight [ 11 % ] of 74 ; p < 00001 ) .
RESULTS	Median anti-gp120 IgG concentration was lower in the ART-96W group ( 230 g/L [ IQR 133-13129 ] ) than in the ART-Def group ( 6870 g/L [ 1706-53645 ] ; p < 00001 ) .
RESULTS	If ART was started between 12 and 24 weeks of age , odds of seropositivity were increased 137 times ( 95 % CI 31-602 ; p = 0001 ) compared with starting it between 0 and 12 weeks .
RESULTS	All children starting ART aged older than 24 weeks were seropositive .
RESULTS	Cumulative viral load to week 84 correlated with anti-gp120 IgG concentrations ( coefficient 054 ; p < 00001 ) and increased odds of seropositivity ( odds ratio 159 [ 95 % CI 11-23 ] ) adjusted for ART initiation age .
CONCLUSIONS	About half of children starting ART before 12 weeks of age were HIV seronegative by almost 2 years of age .
CONCLUSIONS	HIV antibody tests can not be used to reconfirm HIV diagnosis in children starting early ART .
CONCLUSIONS	Long-term effects of seronegativity need further study .
CONCLUSIONS	Clear guidelines are needed for retesting alongside improved diagnostic tests .
BACKGROUND	Wellcome Trust , Medical Research Council , and National Institutes of Health .

###24853544
BACKGROUND	Topical applications of emollients such as sunflower seed oil and Aquaphor have been shown to reduce the incidence of bloodstream infections and mortality of preterm infants in resource-poor settings .
BACKGROUND	The causal mechanism for prevention of infection through cutaneous portals of entry is not well understood .
METHODS	We examined the relationship between skin condition score as a measure of skin barrier integrity and risk for bloodstream infection , and the effect of emollients on that relationship .
METHODS	Data for this study come from a randomized controlled trial of the impact of topical emollient therapy on nosocomial infections in 491 preterm infants < 33 weeks gestational age at Dhaka Shishu Hospital , Bangladesh .
METHODS	Latent growth trajectory model with random-coefficient and multivariable logistic regression were utilized .
RESULTS	Rate of deterioration of skin condition was significantly lower ( P < 0.05 ) in both emollient arms compared with the untreated control group .
RESULTS	Adjusted odds ratio of skin score for infection was 1.32 ( 95 % confidence interval : 1.06-1 .65 ) .
RESULTS	Emollients reduced the incidence of infection only when the skin had no signs of deterioration [ Aquaphor incidence rate ratio : 0.43 ( 95 % confidence interval : 0.19-0 .97 ) and sunflower seed oil incidence rate ratio : 0.46 ( 95 % confidence interval : 0.21-0 .99 ) ] .
CONCLUSIONS	Skin condition deteriorated progressively after birth and compromised skin condition increased the risk of infection .
CONCLUSIONS	Emollients preserved skin integrity and thus prevented infection in preterm neonates .
CONCLUSIONS	To optimize benefits of emollients for the prevention of bloodstream infection , use of emollients should begin immediately after birth when the skin is still intact .

###25246821
OBJECTIVE	To compare gadoxetic acid injection rates of 0.5 mL/s and 1 mL/s for hepatic arterial-phase magnetic resonance ( MR ) imaging .
METHODS	In this prospective study , 101 consecutive patients with suspected focal liver lesions were included and randomly divided into two groups .
METHODS	Each group underwent dynamic liver MR imaging using a 3.0-T scanner after an intravenous injection of gadoxetic acid at rates of either 0.5 mL/s ( n = 50 ) or 1 mL/s ( n = 51 ) .
METHODS	Arterial phase images were analyzed after blinding the injection rates .
METHODS	The signal-to-noise ratios ( SNRs ) of the liver , aorta , portal vein , hepatic vein , spleen , and pancreas were measured .
METHODS	The contrast-to-noise ratios ( CNRs ) of the hepatocellular carcinomas ( HCC ) were calculated .
METHODS	Finally , two experienced radiologists were independently asked to identify , if any , HCCs in the liver on the images and score the image quality in terms of the presence of artifacts and the proper enhancement of the liver , aorta , portal vein , hepatic vein , hepatic artery , spleen , pancreas , and kidney .
RESULTS	The SNRs were not significantly different between the groups ( p = 0.233-0 .965 ) .
RESULTS	The CNRs of the HCCs were not significantly different ( p = 0.597 ) .
RESULTS	The sensitivity for HCC detection and the image quality scores were not significantly different between the two injection rates ( p = 0.082-1 .000 ) .
CONCLUSIONS	Image quality and sensitivity for hepatic HCCs of arterial-phase gadoxetic acid-enhanced MR were not significantly improved by reducing the contrast injection rate to 0.5 mL/s compared with 1 mL/s .

###24852116
BACKGROUND	Gemcitabine plus a platinum-based agent ( eg , cisplatin or oxaliplatin ) is the standard of care for advanced biliary cancers .
BACKGROUND	We investigated the addition of cetuximab to chemotherapy in patients with advanced biliary cancers .
METHODS	In this non-comparative , open-label , randomised phase 2 trial , we recruited patients with locally advanced ( non-resectable ) or metastatic cholangiocarcinoma , gallbladder carcinoma , or ampullary carcinoma and a WHO performance status of 0 or 1 from 18 hospitals across France and Germany .
METHODS	Eligible patients were randomly assigned ( 1:1 ) centrally with a minimisation procedure to first-line treatment with gemcitabine ( 1000 mg/m ( 2 ) ) and oxaliplatin ( 100 mg/m ( 2 ) ) with or without cetuximab ( 500 mg/m ( 2 ) ) , repeated every 2 weeks until disease progression or unacceptable toxicity .
METHODS	Randomisation was stratified by centre , primary site of disease , disease stage , and previous treatment with curative intent or adjuvant therapy .
METHODS	Investigators who assessed treatment response were not masked to group assignment .
METHODS	The primary endpoint was the proportion of patients who were progression-free at 4 months , analysed by intention to treat .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00552149 .
RESULTS	Between Oct 10 , 2007 , and Dec 18 , 2009 , 76 patients were assigned to chemotherapy plus cetuximab and 74 to chemotherapy alone .
RESULTS	48 ( 63 % ; 95 % CI 52-74 ) patients assigned to chemotherapy plus cetuximab and 40 ( 54 % ; 43-65 ) assigned to chemotherapy alone were progression-free at 4 months .
RESULTS	Median progression-free survival was 61 months ( 95 % CI 51-76 ) in the chemotherapy plus cetuximab group and 55 months ( 37-66 ) in the chemotherapy alone group .
RESULTS	Median overall survival was 110 months ( 91-137 ) in the chemotherapy plus cetuximab group and 124 months ( 86-160 ) in the chemotherapy alone group .
RESULTS	The most common grade 3-4 adverse events were peripheral neuropathy ( in 18 [ 24 % ] of 76 patients who received chemotherapy plus cetuximab vs ten [ 15 % ] of 68 who received chemotherapy alone ) , neutropenia ( 17 [ 22 % ] vs 11 [ 16 % ] ) , and increased aminotransferase concentrations ( 17 [ 22 % ] vs ten [ 15 % ] ) .
RESULTS	70 serious adverse events were reported in 39 ( 51 % ) of 76 patients who received chemotherapy plus cetuximab ( 34 events in 19 [ 25 % ] patients were treatment-related ) , whereas 41 serious adverse events were reported in 25 ( 35 % ) of 71 patients who received chemotherapy alone ( 20 events in 12 [ 17 % ] patients were treatment-related ) .
RESULTS	One patient died of atypical pneumonia related to treatment in the chemotherapy alone group .
CONCLUSIONS	The addition of cetuximab to gemcitabine and oxaliplatin did not seem to enhance the activity of chemotherapy in patients with advanced biliary cancer , although it was well tolerated .
CONCLUSIONS	Gemcitabine and platinum-based combination should remain the standard treatment option .
BACKGROUND	Institut National du Cancer , Merck Serono .

###25953830
OBJECTIVE	It is widely known that inflammation is related to type 2 diabetes ( T2D ) , but few studies have shown a direct relationship between the immune system and T2D using a reliable biomarker .
OBJECTIVE	Neutrophil : lymphocyte ratio ( NLR ) is an easy-to-analyze inflammation biomarker , but few studies have assessed the relationship between NLR and T2D .
OBJECTIVE	In order to evaluate how NLR is related to T2D , we designed a large-scale cross-sectional and prospective cohort study in an adult population .
METHODS	Participants were recruited from the Tianjin Medical University General Hospital-Health Management Centre .
METHODS	Both a baseline cross-sectional ( n = 87,686 ) and a prospective ( n = 38,074 ) assessment were performed .
METHODS	Participants without a history of T2D were followed up for 6 years ( with a median follow-up of 2.7 years ) .
METHODS	Adjusted logistic and Cox proportional hazards regression models were used to assess relationships between the quintiles of NLR and T2D ( covariates : age , sex , BMI , smoking status , drinking status , hypertension , hyperlipidemia , and family history of cardiovascular disease , hypertension , hyperlipidemia , or diabetes ) .
RESULTS	The prevalence and incidence of T2D were 4.9 % and 6.8 / 1000 person-years respectively .
RESULTS	The adjusted odds ratio and hazard ratio ( 95 % CI ) of the highest NLR quintile were 1.34 ( 1.21 , 1.49 ) and 1.39 ( 1.09 , 1.78 ) ( both P for trend < 0.01 ) respectively as compared to the lowest quintile of NLR .
RESULTS	Leukocyte , neutrophil , and lymphocyte counts do not significantly predict the eventual development of T2D .
CONCLUSIONS	The present study demonstrates that NLR is related to the prevalence and incidence of T2D , and it suggests that NLR may be an efficient and accurate prognostic biomarker for T2D .

###26255508
OBJECTIVE	To compare the differences in the clinical efficacy on post-stroke upper limb spasmodio hemiplegia among the combined therapy of relaxing needling ( Huici ) technique combined with wheat-grain moxibustion , simple relaxing needling and conventional acupuncture .
METHODS	Ninety patients were-randomized into a group with the combined therapy of relaxing needling technique combined with wheat-grain moxibustion ( a combined therapy group ) , a simple relaxing needling group and a conventional acupuncture group , 30 cases in each group .
METHODS	In the combined therapy group , the relaxing needling technique was used in combination with wheat-grain moxibustion .
METHODS	The relaxing needling technique was applied to Jianyu ( LI 15 ) , Quchi ( LI 11 ) , Shousanli ( LI 10 ) , etc. .
METHODS	The wheat-grain moxibustion was applied to Qihai ( CV 6 ) , Guanyuan ( CV 4 ) , Mingmen ( GV 4 ) , etc. .
METHODS	In thel simple relaxing needling group , the relaxing needling technique was used simply .
METHODS	In the conventional acupuncture group , the conventional lifting , thrusting and rotating technique with filiform needle was adopted at the same acupoints as the simple relaxing needling group .
METHODS	The treatment was given once every day ; 6 treatments made one session .
METHODS	Totally 4 sessions were required , with 1 day at intervals .
METHODS	The modified Ashworth scale ( MAS ) , Fugl-Meyer assessment ( FMA ) and Barthel index ( BD were adopted to assess the upper limb muscle tension , motor functioni and daily life activity .
RESULTS	After treatment , MAS score was all reduced as compared with that before treatment in each group , and FMA score and BI score were increased as compared with those before treatment ( all P < 0.01 ) .
RESULTS	MAS score in the combined therapy group was lower than that in either the simple relaxing needling group or the conventional acupuncture group ( both P < 0.01 ) , and the score in the simple relaxing needling group was lower than that in the conventional acupuncture group ( P < 0.05 ) .
RESULTS	FMA score and BI score in the combined therapy group were higher than those in the simple relaxing needling group and the conventional acupuncture group ( both P < 0.01 ) .
RESULTS	FMA score in the simple relaxing needleing group was higher than that the Enventional acupuncture group ( P < 0.05 ) .
RESULTS	The total effective rate in the combined therapy group was 93.3 % ( 28/30 ) , higher ; than 86.7 % ( 26/30 ) in the simple relaxing needling group ( P < 0.01 ) , and 83.8 % ( 25/30 ) in the conventionaP acupuncture group ( P < 0.01 ) .
CONCLUSIONS	The combined therapy of relaxing needling technique and wheat-grain moxibustion achieves more satisfactory efficacy on post-stroke upper limb spasmodic hemiplegia compared with the simple relaxing needling and conventional acupuncture .

###24575736
OBJECTIVE	To determine if lactate concentrations in jugular venous and auricular arterial blood differ in anesthetized sheep .
METHODS	Prospective , controlled experimental study .
METHODS	Twelve healthy adult ewes , 4-7years and weighing 62-77kg .
METHODS	Jugular venous blood was collected before anesthesia ( PreOv ) for measurement of lactate concentration , packed cell volume and total protein .
METHODS	Ewes were administered a standard anesthesia protocol .
METHODS	Jugular venous ( IntraOv ) and auricular arterial ( IntraOa ) blood samples were obtained 40minutes after induction of anesthesia , and again in recovery ( PostOv and PostOa ) .
METHODS	An additional blood sample was drawn 6weeks post-operatively from non-fasted sheep ( NF_Lact ) .
METHODS	Lactate concentrations were compared among PreOv , IntraOv and IntraOa , PostOv and PostOa , and between PreOv and NF_Lact with paired t-test and repeated measure analyses of variance ( anova ) with PreOv as a covariate ( p0 .05 ) .
RESULTS	IntraOv lactate concentration had decreased from PreOv There were significant differences between arterial and venous IntraO and PostO lactate concentrations .
RESULTS	There was no significant difference between IntraO and PostO , or PreOv and NF_Lact .
CONCLUSIONS	Lactate concentrations were significantly lower in anesthetized sheep compared to non-anesthetized sheep .
CONCLUSIONS	Lactate concentrations in venous blood were higher than in arterial blood .
CONCLUSIONS	Therefore , anesthetic status and sampling site should be considered when interpreting lactate concentrations , and the sampling site should be consistent for repeated measurements .

###24444287
OBJECTIVE	This report details enrolment findings related to a Canadian randomized controlled trial comparing immediate to delayed intrauterine contraception ( IUC ) placement after a second trimester abortion .
OBJECTIVE	We report acceptance of IUC , satisfaction with prior contraception , adherence to the CONSORT criteria , and challenges faced in the recruitment process .
METHODS	Women seeking second trimester abortion and selecting either of two methods of IUC as their preferred contraception method were enrolled and randomized to insertion either immediately post-abortion or four weeks later .
METHODS	Enrolled participants completed a Contraception Satisfaction Questionnaire detailing prior contraceptive satisfaction .
RESULTS	Among 1813 women assessed , 1500 ( 83 % ) met eligibility criteria and IUC was chosen for post-abortion contraception by over one half of them ( 792/1500 , 53 % ) .
RESULTS	When both types of device were available cost-free , women selected the levonorgestrel-releasing intrauterine system more than 20 times more frequently than a copper IUD .
RESULTS	Participants had an average age of 26.0 ( standard deviation [ SD ] 6.8 ) years , and an average gestational age of 16.1 ( SD 3.1 ) weeks .
RESULTS	Almost one half ( 48.4 % ) had had a prior abortion and 46.9 % had a prior delivery .
RESULTS	Two thirds of participants were using a contraception method at the time of conception , but almost one third of these were using methods in the lowest tiers of effectiveness .
RESULTS	There was a weak correlation between prior contraceptive compliance and education level .
CONCLUSIONS	More than one half of eligible women seeking a second-trimester abortion chose IUC for post-abortion contraception .
CONCLUSIONS	In Canada , health care for unintended pregnancies is universally subsidized but contraception is not .
CONCLUSIONS	Offering comprehensive information on the range of contraceptive methods and providing cost-free IUC is an effective strategy to increase uptake of intrauterine contraception among Canadian women who wish to prevent further unintended pregnancy .

###24650952
OBJECTIVE	To assess efficacy and safety of lixisenatide once-daily versus placebo in type 2 diabetes mellitus ( T2DM ) patients inadequately controlled on sulfonylurea ( SU ) metformin .
METHODS	In this randomized , double-blind , two-arm , parallel-group , multicenter study , patients received lixisenatide 20 g once-daily or placebo for 24 weeks in a stepwise dose increase on top of SUs metformin .
METHODS	Primary outcome was change in HbA1c from baseline to Week 24 .
RESULTS	Lixisenatide provided a significant reduction in HbA1c at Week 24 versus placebo ( LS mean : -0.85 % vs. -0.10 % ; p < 0.0001 ) and more patients achieved HbA1c < 7.0 % ( 36.4 % vs. 13.5 % ; p < 0.0001 ) .
RESULTS	Lixisenatide significantly lowered FPG and body weight versus placebo .
RESULTS	In breakfast meal test patients , lixisenatide reduced 2-hour PPG versus placebo ( LS mean : -111.48 vs. -3.80 mg/dL [ -6.19 vs. -0.21 mmol/L ] ; p < 0.0001 ) and glucose excursion ( -94.11 vs. +6.24 mg/dL [ -5.22 vs. +0.35 mmol/L ] ) , and reduced 2-hour glucagon , insulin , proinsulin , and C-peptide .
RESULTS	The percentage of AEs was 68.3 % for lixisenatide and 61.1 % for placebo ; and for SAEs : 3.5 % versus 5.6 % , respectively .
RESULTS	Lixisenatide did not significantly increase symptomatic hypoglycemia versus placebo ( 15.3 % vs. 12.3 % , respectively ) ; one severe episode of hypoglycemia was reported with lixisenatide .
CONCLUSIONS	Once-daily lixisenatide significantly improved glycemic control , with a pronounced postprandial effect , without significant increase in symptomatic/severe hypoglycemia risk and with weight loss over 24 weeks .

###25069344
OBJECTIVE	To compare the efficacy of two surgical techniques for controllong nasal width after Le Fort I osteotomy .
METHODS	Fifty-five patients who received the Le Fort I osteotomy have been included in this study .
METHODS	They were randomly divided into 2 groups .
METHODS	The experimental group received extraoral ABS , and the control group received traditional intraoral ABS .
METHODS	3D photos of the patient 's face were taken before operation and at postoperative 3 months .
METHODS	Alar width was measured on the 3D photos .
METHODS	Data was reported as means and standard deviations , and statistic analysis was done by using student t test .
RESULTS	Compared with presurgical data , G. lat-G .
RESULTS	lat increased by ( 2.66 + / - 1.47 ) mm , Al-Al increased by ( 2.20 + / - 1.22 ) mm and Sbal-Sbal increased by ( 1.30 + / - 1.33 ) mm in experimental group .
RESULTS	G. lat-G .
RESULTS	lat increased by ( 1.38 + / - 1.29 ) mm , Al-Al increased by ( 1.06 + / - 0.95 ) mm and Sbal-Sbal increased by ( 0.36 + / - 1.33 ) mm in the control group .
RESULTS	There was significant difference between two groups .
CONCLUSIONS	The surgical technique of ABS is the most important factor for determining the postoperative alar width .
CONCLUSIONS	Both techniques have better effect on the Sbal-Sbal width control than the G. lat-G .
CONCLUSIONS	lat and Al-Al width control .
CONCLUSIONS	Traditional intraoral ABS can more effectively control the alar width .
CONCLUSIONS	Both techniques can not completely control the alar base widening after Le Fort I osteotomy .

###24494602
OBJECTIVE	Artemisinin-based combination therapies ( ACTs ) are essential for the effective control of falciparum malaria in endemic countries .
OBJECTIVE	However , in most countries , such choice has been carried out without knowing their effectiveness when deployed in real-life conditions , that is , when treatment is not directly observed .
OBJECTIVE	We report here the results of a study assessing the effectiveness of the two ACTs currently recommended in Burkina Faso for the treatment of uncomplicated malaria , that is , artemether-lumefantrine ( AL ) and artesunate-amodiaquine ( ASAQ ) .
METHODS	Between September 2008 and January 2010 , 340 children were randomised to one of the two study arms and followed up for 42 days .
METHODS	Treatment was administered according to routine practices , that is , the first dose was given by study nurses who explained to the parent/guardian how to administer the other doses at home during the following 2 days .
RESULTS	The results showed a significantly higher unadjusted adequate clinical and parasitological response in the ASAQ ( 58.4 % ) than in the AL arm ( 46.1 % ) at day 28 but these trends were similar after correction with PCR data ( ASAQ ( 89.7 % ) and AL ( 89.8 % ) ) .
RESULTS	New infections started to appear after day 14 , first in the AL and then in the ASAQ arm but at day 42 day of follow-up we observed no difference in the occurrence of recrudescent infection .
CONCLUSIONS	Despite a lower cure rate than those reported in efficacy studies in which the treatment administration was directly observed , both AL and ASAQ can still be used for the treatment of uncomplicated malaria in Burkina Faso .

###24603863
OBJECTIVE	Social factors may be of importance causally and act as maintenance factors in patients with anorexia nervosa .
OBJECTIVE	Oxytocin is a neuromodulatory hormone involved in social emotional processing associated with attentional processes .
OBJECTIVE	This study aimed to examine the impact of oxytocin on attentional processes to social faces representing anger , disgust , and happiness in patients with anorexia nervosa .
METHODS	A double-blind , placebo-controlled within-subject crossover design was used .
METHODS	Intranasal oxytocin or placebo followed by a visual probe detection task with faces depicting anger , disgust , and happiness was administered to 64 female subjects : 31 patients with anorexia nervosa and 33 control students .
RESULTS	Attentional bias to the disgust stimuli was observed in both groups under the placebo condition .
RESULTS	The attentional bias to disgust was reduced under the oxytocin condition ( a moderate effect in the patient group ) .
RESULTS	Avoidance of angry faces was observed in the patient group under the placebo condition and vigilance was observed in the healthy comparison group ; both of these information processing responses were moderated by oxytocin producing an increase in vigilance in the patients .
RESULTS	Happy/smiling faces did not elicit an attentional response in controls or the patients under either the placebo or oxytocin conditions .
CONCLUSIONS	Oxytocin attenuated attentional vigilance to disgust in patients with anorexia nervosa and healthy controls .
CONCLUSIONS	On the other hand , oxytocin changed the response to angry faces from avoidance to vigilance in patients but reduced vigilance to anger in healthy controls .
CONCLUSIONS	We conclude that patients with anorexia nervosa appear to use different strategies/circuits to emotionally process anger from their healthy counterparts .

###24995954
OBJECTIVE	The examination of cough reflex sensitivity through inhalational challenge can be utilized to demonstrate pharmacological end points .
OBJECTIVE	Here we compare the effect of butamirate , dextromethorphan and placebo on capsaicin-induced cough in healthy volunteers .
METHODS	In this randomized , placebo-controlled , six way crossover study the effect of dextromethrophan 30mg , four doses of butamirate and placebo was evaluated on incremental capsaicin challenges performed at baseline and 2 , 4 , 6 , 8 , 12 and 24h following dosing .
METHODS	The primary end point was the area under the curve ( AUC ( 0,12 h ) ) of log10 C5 from pre-dose to 12h after dosing .
METHODS	Plasma butamirate metabolites were analyzed to evaluate pharmacokinetic and pharmacodynamic relationships .
RESULTS	Thirty-four subjects ( 13 males , median age 25 years ) completed the study .
RESULTS	Cough sensitivity decreased from baseline in all arms of the study .
RESULTS	Dextromethorphan was superior to placebo ( P = 0.01 ) but butamirate failed to show significant activity with maximum attenuation at the 45mg dose .
RESULTS	There was no apparent relationship between pharmacokinetic and pharmacodynamic parameters for butamirate .
CONCLUSIONS	We have demonstrated for the first time that dextromethorphan attenuates capsaicin challenge confirming its broad activity on the cough reflex .
CONCLUSIONS	The lack of efficacy of butamirate could be due to formulation issues at higher doses .

###25219639
BACKGROUND	A variety of apheresis instruments are now available on the market for double dose plateletpheresis .
BACKGROUND	We compared three apheresis devices ( Fenwal Amicus , Fresenius COM.TEC and Trima Accel ) with regard to processing time , platelet ( PLT ) yield , collection efficiency ( CE ) and collection rate ( CR ) .
METHODS	The single-needle or double-needle double plateletpheresis procedures of the three instruments were compared in a retrospective , randomized study in 135 donors .
RESULTS	In the pre-apheresis setting , 45 double plateletpheresis procedures performed with each instrument revealed no significant differences in donor 's age , sex , weight , hemoglobin , white blood cell and PLT count between three groups .
RESULTS	The blood volume processed to reach a target PLT yield of610 ( 11 ) was higher in the COM.TEC compared with the Amicus and Trima ( 4394 vs. 3780 and 3340ml , respectively ; p < 0.001 ) .
RESULTS	Also there was a significantly higher median volume of ACD used in collections on the COM.TEC compared with the Amicus and Trima ( 426 vs. 387 and 329ml , respectively ; p < 0.001 ) .
RESULTS	There was a significantly higher median time needed for the procedures on the COM.TEC compared with the Amicus and Trima ( 66 vs. 62 and 63min , respectively ; p = 0.024 ) .
RESULTS	The CE was significantly higher with the Trima compared with the Amicus and COM.TEC ( 83.5717.19 vs. 66.713.47 and 58.795.14 % , respectively ; p < 0.001 ) .
RESULTS	Also , there was a significantly higher product volume on the Trima compared with the Amicus and COM.TEC ( 395.56 vs. 363.11 and 386.4 ml , respectively ; p = 0.008 ) .
RESULTS	Additionally , the CR was significantly lower with the COM.TEC compared with the Amicus and Trima ( 0.0920.011 vs. 0.0990.013 and 0.0970.013 plt10 ( 11 ) / min , respectively ; p = 0.039 ) .
RESULTS	There was no significant differences in PLT yield between the three groups ( p = 0.636 ) .
CONCLUSIONS	Trima single-needle device collected double dose platelets more efficiently than Amicus and COM.TEC double-needle devices .
CONCLUSIONS	Blood volume processed , ACD-A volume , and median separation time was significantly higher with the COM.TEC .
CONCLUSIONS	Also , the CR was significantly lower with the COM.TEC .

###25423953
OBJECTIVE	To investigate clinical outcomes of coronary intervention using a biolimus-eluting stent ( BES ) compared with a sirolimus-eluting stent ( SES ) in patients with acute myocardial infarction ( AMI ) in the Limus Eluted from A Durable versus ERodable Stent ( LEADERS ) coating trial at the final 5-year follow-up .
METHODS	The LEADERS trial is a multicentre all-comer study , where patients ( n = 1707 ) were randomised to percutaneous intervention with either BES containing biodegradable polymer or SES containing durable polymer .
METHODS	Out of 1707 patients enrolled in this trial , 573 patients had percutaneous coronary intervention for AMI ( BES = 280 , SES = 293 ) and were included in the current analysis .
METHODS	Patient-oriented composite endpoint ( POCE , including all death , all myocardial infarction ( MI ) and all revascularisations ) , major adverse cardiac events ( MACE , including cardiac death , MI and clinically indicated target vessel revascularisation ) and stent thrombosis were assessed at 5-year follow-up .
RESULTS	The baseline clinical , angiographic and procedural characteristics were well matched between BES and SES groups .
RESULTS	In all patients with AMI , coronary intervention with a BES , compared with SES , significantly reduced POCE ( 28.9 % vs 42.3 % ; relative risk ( RR ) 0.61 , 95 % CI 0.47 to 0.82 , p = 0.001 ) at 5-year follow-up .
RESULTS	There was also a reduction in MACE rate in the BES group ( 18.2 % vs 25.9 % ; RR 0.67 , 95 % CI 0.47 to 0.95 , p = 0.025 ) ; however , there was no difference in cardiac death and stent thrombosis .
RESULTS	In patients with ST-elevation MI ( STEMI ) , coronary intervention with BES significantly reduced POCE ( 24.4 % vs 39.3 % ; RR 0.55 , 95 % CI 0.36 to 0.85 , p = 0.006 ) , MACE ( 12.6 % vs 25.0 % ; RR 0.47 , 95 % CI 0.26 to 0.83 , p = 0.008 ) and cardiac death ( 3.0 % vs 11.4 % ; RR 0.25 , 95 % CI 0.08 to 0.75 , p = 0.007 ) , along with a trend towards reduction in definite stent thrombosis ( 3.7 % vs 8.6 % ; RR 0.41 , 95 % CI 0.15 to 1.18 , p = 0.088 ) , compared with SES .
CONCLUSIONS	BES , compared with SES , significantly improved safety and efficacy outcomes in patients with AMI , especially those with STEMI , at 5-year follow-up .
BACKGROUND	NCT 00389220 .

###25868406
BACKGROUND	The need for a fundoplication during repair of paraesophageal hiatal hernias ( PEH ) remains unclear .
BACKGROUND	Prevention of gastroesophageal reflux represents a trade-off against the risk of fundoplication-related side effects .
BACKGROUND	The aim of this trial was to compare laparoscopic mesh-augmented hiatoplasty with simple cardiophrenicopexy ( LMAH-C ) with laparoscopic mesh-augmented hiatoplasty with fundoplication ( LMAH-F ) in patients with PEH .
METHODS	The study was designed as a patient - and assessor-blinded randomized controlled pilot trial , registration number : DRKS00004492 ( www.germanctr.de / ) .
METHODS	Patients with symptomatic PEH were eligible and assigned by central randomization to LMAH-C or LMAH-F .
METHODS	Endpoints were postoperative gastroesophageal reflux , complications , and quality of life 12 months postoperatively .
RESULTS	Forty patients ( 9 male , 31 female ) were randomized .
RESULTS	Patients were well matched for baseline characteristics .
RESULTS	At 3 months , the DeMeester score was higher after LMAH-C compared with LMAH-F ( 40.9 39.9 vs. 9.6 17 ; p = 0.048 ) .
RESULTS	At 12 months , the reflux syndrome score was higher after LMAH-C compared with LMAH-F ( 1.9 1.2 vs. 1.1 0.4 ; p = 0.020 ) .
RESULTS	In 53 % of LMAH-C patients and 17 % of LMAH-F patients , postoperative esophagitis was present ( p = 0.026 ) .
RESULTS	Values of dysphagia ( 2.1 1.6 vs 1.9 1.4 ; p = 0.737 ) , gas bloating ( 2.6 1.4 vs 2.8 1.4 ; p = 0.782 ) , and quality of life ( 116.0 16.2 vs 115.9 15.8 ; p = 0.992 ) were similar .
RESULTS	Relevant postoperative complications occurred in 4 ( 10 % ) patients and did not differ between the groups .
CONCLUSIONS	Laparoscopic repair of PEH should be combined with a fundoplication to avoid postoperative gastroesophageal reflux and resulting esophagitis .
CONCLUSIONS	Fundoplication-related side effects do not appear to be clinically relevant .
CONCLUSIONS	Multicenter randomized trials are required to confirm these findings .

###25784663
OBJECTIVE	This study examined parental factors associated with outcomes of youth in the Treatment Options for type 2 Diabetes in Adolescents and Youth ( TODAY ) clinical trial .
METHODS	Of 699 youth with type 2 diabetes in the TODAY cohort , 623 ( 89.1 % ) had a parent participate and provide data at baseline , including weight , HbA1c , blood pressure , symptoms of depression , binge eating ( BE ) , and medical history .
METHODS	Youth were followed 2-6 .5 years .
METHODS	Data were analyzed using regression models and survival curve methods .
RESULTS	Parental diabetes ( 43.6 % of parents ) was associated with higher baseline HbA1c ( P < 0.0001 ) and failure of youths to maintain glycemic control on study treatment ( 53.6 % vs. 38.2 % failure rate among those without a diabetic parent , P = 0.0002 ) .
RESULTS	Parental hypertension ( 40.6 % of parents ) was associated with hypertension in youth during TODAY ( 40.4 % vs. 27.4 % of youth with and without parental hypertension had hypertension , P = 0.0008 ) and with higher youth baseline BMI z scores ( P = 0.0038 ) .
RESULTS	Parents had a mean baseline BMI of 33.6 kg/m ( 2 ) .
RESULTS	Parental obesity ( BMI > 30 kg/m ( 2 ) ) was associated with higher baseline BMI z scores in the youth ( P < 0.0001 ) .
RESULTS	Depressive symptoms in parents ( 20.6 % of parents ) were related to youth depressive symptoms at baseline only ( P = 0.0430 ) ; subclinical BE in parents was related to the presence of subclinical BE ( P = 0.0354 ) and depressive symptoms ( P = 0.0326 ) in youth throughout the study period .
CONCLUSIONS	Parental diabetes and hypertension were associated with lack of glycemic control , hypertension , and higher BMI z scores in youth .
CONCLUSIONS	Further research is needed to better understand and address parental biological and behavioral factors to improve youth health outcomes .

###25439606
OBJECTIVE	To compare the 5-year outcomes of the Ahmed FP7 Glaucoma Valve ( AGV ) ( New World Medical , Cucamonga , CA ) and the Baerveldt 101-350 Glaucoma Implant ( BGI ) ( Abbott Medical Optics , Abbott Park , IL ) for the treatment of refractory glaucoma .
METHODS	Multicenter , randomized , controlled clinical trial .
METHODS	A total of 276 patients , including 143 in the AGV group and 133 in the BGI group .
METHODS	Patients aged 18 to 85 years with previous intraocular surgery or refractory glaucoma and intraocular pressure ( IOP ) of 18 mmHg in whom glaucoma drainage implant ( GDI ) surgery was planned were randomized to implantation of an AGV or a BGI .
METHODS	Surgical failure , IOP , visual acuity ( VA ) , use of glaucoma medications , and complications .
RESULTS	At 5 years , IOP ( mean standard deviation [ SD ] ) was 14.74.4 mmHg in the AGV group and 12.74.5 mmHg in the BGI group ( P = 0.015 ) .
RESULTS	The number of glaucoma medications in use at 5 years ( mean SD ) was 2.21.4 in the AGV group and 1.81.5 in the BGI group ( P = 0.28 ) .
RESULTS	The cumulative probability of failure during 5 years of follow-up was 44.7 % in the AGV group and 39.4 % in the BGI group ( P = 0.65 ) .
RESULTS	The number of subjects failing because of inadequately controlled IOP or reoperation for glaucoma was 46 in the AGV group ( 80 % of AGV failures ) and 25 in the BGI group ( 53 % of BGI failures ; P = 0.003 ) .
RESULTS	Eleven eyes in the AGV group ( 20 % of AGV failures ) experienced persistent hypotony , explantation of implant , or loss of light perception compared with 22 eyes ( 47 % of failures ) in the BGI group .
RESULTS	Change in logarithm of the minimum angle of resolution VA ( mean SD ) at 5 years was 0.420.99 in the AGV group and 0.430.84 in the BGI group ( P = 0.97 ) .
CONCLUSIONS	Similar rates of surgical success were observed with both implants at 5 years .
CONCLUSIONS	The BGI produced greater IOP reduction and a lower rate of glaucoma reoperation than the AGV , but the BGI was associated with twice as many failures because of safety issues .

###25098088
BACKGROUND	Elective cholecystectomy for symptomatic gall stone disease carries low risk of postoperative infective complications .
BACKGROUND	Yet the routine use of prophylactic antibiotic is in vogue in many centres .
BACKGROUND	The aim of this study was to find out the efficacy of antibiotic prophylaxis in preventing postoperative infective complications in low risk elective laparoscopic cholecystectomy patients .
METHODS	Randomised controlled trial was carried out in our hospital from 1st Nov 2009 to 15th Oct 2011 .
METHODS	A total of 350 patients were included in the study and were divided into Group A ( n = 177 ) .
METHODS	and Group B ( n = 173 ) .
METHODS	Group A was given single dose of injection Celfuroxime 1.5 gm as prophylactic antibiotic at the time of induction of anaesthesia , and Group B was not given any antibiotic .
METHODS	In both groups , age , sex , duration of surgery , American Society of Anesthesiologists classification , duration of surgery and length of hospital stay were recorded .
METHODS	Patients were followed-up weekly for 4 weeks and rates of superficial surgical site infections as well as intra-abdominal infections were recorded .
RESULTS	There were no significant differences in both groups in terms of age , sex , duration of surgery , length of hospital stay .
RESULTS	Eight ( 4.5 % ) cases of superficial surgical site infection were noted in Group A and 7 ( 4.0 % ) in Group B which was insignificant statistically ( p > 0.05 ) .
CONCLUSIONS	In low risk patients antibiotic prophylaxis does not seem to affect the incidence of postoperative infective complications in elective laparoscopic cholecystectomy .
CONCLUSIONS	The use of prophylactic antibiotics should be reserved for high risk patients undergoing laparoscopic cholecystectomy .

###24532031
BACKGROUND	Myocardial perfusion SPECT ( MPS ) is one of the frequently used methods for quantification of perfusion defects in patients with known or suspected coronary artery disease .
BACKGROUND	This article describes open access software for automated quantification in MPS of stress-induced ischemia and infarction and provides phantom and in vivo validation .
RESULTS	A total of 492 patients with known or suspected coronary artery disease underwent both stress and rest MPS .
RESULTS	The proposed perfusion analysis algorithm ( Segment ) was trained in 140 patients and validated in the remaining 352 patients using visual scoring in MPS by an expert reader as reference standard .
RESULTS	Furthermore , validation was performed with simulated perfusion defects in an anthropomorphic computer model .
RESULTS	Total perfusion deficit ( TPD , range 0-100 ) , including both extent and severity of the perfusion defect , was used as the global measurement of the perfusion defects .
RESULTS	Mean bias SD between TPD by Segment and the simulated TPD was 3.6 3.8 ( R ( 2 ) = 0.92 ) .
RESULTS	Mean bias SD between TPD by Segment and the visual scoring in the patients was 1.2 2.9 ( R ( 2 ) = 0.64 ) for stress-induced ischemia and -0.3 3.1 ( R ( 2 ) = 0.86 ) for infarction .
CONCLUSIONS	The proposed algorithm can detect and quantify perfusion defects in MPS with good agreement to expert readers and to simulated values in a computer phantom .

###24444783
OBJECTIVE	Pentoxifylline , a nonselective phosphodiesterase inhibitor , shows vasodilator effects in certain vascular beds and reduces blood viscosity .
OBJECTIVE	We have previously shown that under states of vasoconstriction an interaction between circulating erythrocytes and leukocytes may play a role in the control of blood flow .
OBJECTIVE	The reason for this observation is not entirely clear but may be related to a mechanical interaction between red and white blood cells .
OBJECTIVE	In the present study we hypothesized that pentoxifylline may alter this interaction during oxygen-induced vasoconstriction .
METHODS	24 healthy male subjects participated in this double masked , randomized , placebo-controlled 2 way cross over trial .
METHODS	In order to increase white blood cell count ( WBC ) count , 300 g of G-CSF was administered intravenously .
METHODS	Vasoconstriction of retinal vessels was induced by oxygen inhalation .
METHODS	400mg of pentoxifylline or placebo was infused at two different study days .
METHODS	White blood cell flux was assessed with the blue-field entoptic technique .
METHODS	Vessel calibers were measured with a dynamic vessel analyzer ( DVA ) and red blood cell velocity ( RBCV ) was determined with laser Doppler velocimetry ( LDV ) .
METHODS	Retinal blood flow was calculated based on retinal vessel diameters and RBCV .
RESULTS	Administration of G-CSF induced a significant increase in WBC , both in the placebo and the pentoxifylline group ( p < 0.01 for both groups ) .
RESULTS	Retinal vessel diameter , RBCV , calculated retinal blood flow and white blood cell flow were not altered by administration of pentoxifylline .
RESULTS	Hyperoxia induced a pronounced decrease in retinal blood flow parameters .
RESULTS	No difference was observed between groups during oxygen breathing in vessel diameters ( p = 0.54 ) , RBCV ( p = 0.34 ) , calculated retinal blood flow ( p = 0.3 ) and white blood cell flow ( p = 0.26 ) .
CONCLUSIONS	Our data indicate that short time administration of pentoxifylline does not alter the oxygen-induced effect on ocular blood flow parameters during leukocytosis .
CONCLUSIONS	Whether long-term treatment could improve retinal blood flow under states of vasoconstriction remains to be investigated .

###24952866
BACKGROUND	Randomized clinical trials ( RCTs ) suggest benefits for the transradial approach to percutaneous coronary intervention ( PCI ) for ST-elevation myocardial infarction ( STEMI ) .
BACKGROUND	However , transradial PCI may delay reperfusion , leading to its avoidance .
BACKGROUND	We sought to quantify the delay in reperfusion from transradial PCI ( `` transradial delay '' ) that would need to be introduced to offset the potential mortality benefit of transradial PCI , compared with transfemoral , observed in RCTs .
METHODS	We developed a decision-analytic model to compare transfemoral and transradial PCI in STEMI .
METHODS	Thirty-day mortality rates were estimated by pooling STEMI patients from 2 RCTs comparing transfemoral and transradial PCI .
METHODS	We projected the impact of transradial delay using estimates of the increase in mortality associated with door-to-balloon time delays .
METHODS	Sensitivity analyses were performed to understand the impact of uncertainty in assumptions .
RESULTS	In the base case , a transradial delay of 83.0 minutes was needed to offset the mortality benefit of transradial PCI .
RESULTS	When the mortality benefit of transradial PCI was one-quarter that observed in RCTs , the delay associated with equivalent mortality was 20.9 minutes .
RESULTS	In probabilistic sensitivity analyses , transradial PCI was preferred over transfemoral PCI in 97.5 % of simulations when transradial delay was 30 minutes and in 79.0 % of simulations when delay was 60 minutes .
CONCLUSIONS	A substantial transradial delay is required to eliminate even a fraction of the mortality benefit observed with transradial PCI in RCTs .
CONCLUSIONS	Results were robust to changing multiple assumptions and have implications for operators reluctant to transition to transradial PCI in STEMI because of concern for delaying reperfusion .

###25063373
OBJECTIVE	Heart rate ( HR ) plays an important role in the assessment of stress during therapeutic hypothermia ( TH ) for neonatal encephalopathy ; we aimed to quantify the effect on HR of endotracheal ( ET ) intubation and drugs given to facilitate it .
OBJECTIVE	If atropine premedication independently increased HR , the main indicator of effective sedation , we hypothesised that increased sedation would have been given .
METHODS	Thirty-two , term , neonates recruited into a randomised pilot study comparing TH and TH combined with 50 % Xenon inhalation were studied .
METHODS	Indications for ET intubation included : resuscitation at delivery , clinical need and elective re-intubation with a cuffed ET tube if randomised to Xenon .
METHODS	Standard intubation drugs comprised one or more of intravenous morphine , atropine , and suxamethonium .
METHODS	Local cooling guidelines were followed including morphine infusion for sedation .
RESULTS	At postnatal hours five to eight atropine increased HR in a linear regression model ( p < 0.01 ) .
RESULTS	All other independent variables were excluded .
RESULTS	Where more than one dose of atropine was given total morphine sedation given up to 8h into the treatment period was significantly higher ( p < 0.01 ) .
CONCLUSIONS	We have shown that atropine premedication for ET intubation significantly increased HR , the main indicator of effective sedation and total morphine dose for sedation during early TH was increased where more than one dose of atropine was given .
CONCLUSIONS	Bradycardia was not reported in any neonate , even without atropine premedication .
CONCLUSIONS	We suggest that the use of atropine as part of standard premedication for ET intubation of term neonates undergoing TH should be reconsidered .

###25230094
OBJECTIVE	Narrowband UV-B ( NB-UV-B ) phototherapy is used extensively to treat vitiligo .
OBJECTIVE	Afamelanotide , an analogue of - melanocyte-stimulating hormone , is known to induce tanning of the skin .
OBJECTIVE	To evaluate the efficacy and safety of combination therapy for generalized vitiligo consisting of afamelanotide implant and NB-UV-B phototherapy .
METHODS	This study was performed in 2 academic outpatient dermatology centers and 1 private dermatology practice .
METHODS	We enrolled men and women 18 years or older with Fitzpatrick skin phototypes ( SPTs ) III to VI and a confirmed diagnosis of nonsegmental vitiligo that involved 15 % to 50 % of total body surface area .
METHODS	Vitiligo was stable or slowly progressive for 3 months .
METHODS	Patients were randomized to combination therapy ( n = 28 ) vs NB-UV-B monotherapy ( n = 27 ) .
METHODS	After 1 month of NB-UV-B phototherapy , 16 mg of afamelanotide was administered subcutaneously to the combination therapy group monthly for 4 months while NB-UV-B phototherapy continued ; the other group continued to receive NB-UV-B monotherapy .
METHODS	Narrowband UV-B monotherapy vs combined NB-UV-B phototherapy and afamelanotide .
METHODS	Response on the Vitiligo Area Scoring Index and Vitiligo European Task Force scoring system .
RESULTS	Response in the combination therapy group was superior to that in the NB-UV-B monotherapy group ( P < .05 ) at day 56 .
RESULTS	For the face and upper extremities , a significantly higher percentage of patients in the combination therapy group achieved repigmentation , and at earlier times ( face , 41.0 vs 61.0 days [ P = .001 ] ; upper extremities , 46.0 vs 69.0 days [ P = .003 ] ) .
RESULTS	In the combination therapy group , repigmentation was 48.64 % ( 95 % CI , 39.49 % -57.80 % ) at day 168 vs 33.26 % ( 95 % CI , 24.18 % -42.33 % ) in the NB-UV-B monotherapy group .
RESULTS	Notable adverse events included erythema in both groups and minor infections and nausea in the combination therapy group .
RESULTS	Comparison between Fitzpatrick SPTs showed patients with SPTs IV to VI in the combination therapy group had improvement in the Vitiligo Area Scoring Index at days 56 and 84 ( P < .05 ) ; no significant difference was noted in patients with SPT III .
CONCLUSIONS	A combination of afamelanotide implant and NB-UV-B phototherapy resulted in clinically apparent , statistically significant superior and faster repigmentation compared with NB-UV-B monotherapy .
CONCLUSIONS	The response was more noticeable in patients with SPTs IV to VI .
BACKGROUND	clinicaltrials.gov Identifier : NCT01430195 .

###24917119
BACKGROUND	Cough is an extremely common problem in pediatrics , mostly triggered and perpetuated by inflammatory processes or mechanical irritation leading to viscous mucous production and increased sensitivity of the cough receptors .
BACKGROUND	Protecting the mucosa might be very useful in limiting the contact with micro-organisms and irritants thus decreasing the inflammation and mucus production .
BACKGROUND	Natural molecular complexes can act as a mechanical barrier limiting cough stimuli with a non pharmacological approach but with an indirect anti-inflammatory action .
OBJECTIVE	Aim of the study was to assess the efficacy of a medical device containing natural functional components in the treatment of cough persisting more than 7 days .
METHODS	In this randomized , parallel groups , double-blind vs. placebo study , children with cough persisting more than 7 days were enrolled .
METHODS	The clinical efficacy of the study product was assessed evaluating changes in day - and night-time cough scores after 4 and 8 days ( t4 and t8 ) of product administration .
RESULTS	In the inter-group analysis , in the study product group compared with the placebo group , a significant difference ( t4 study treatment vs. t4 placebo , p = 0.03 ) was observed at t4 in night-time cough score.Considering the intra-group analysis , only the study product group registered a significant improvement from t0 to t4 in both day-time ( t0 vs. t4 , p = 0.04 ) and night-time ( t0 vs. t4 , p = 0.003 ) cough scores.A significant difference , considering the study product , was also found in the following intra-group analyses : day-time scores at t4 vs. t8 ( p = 0.01 ) and at t0 vs. t8 ( p = 0.001 ) ; night-time scores at t4 vs. t8 ( p = 0.05 ) , and at t0 vs. t8 ( p = 0.005 ) .
RESULTS	Considering a subgroup of patients with higher cough ( 3 ) scores , 92.9 % of them in the study product group improved at t0 vs. t4 day-time .
CONCLUSIONS	Grintuss pediatric syrup showed to possess an interesting profile of efficacy and safety in the treatment of cough persisting more than 7 days .

###25873249
BACKGROUND	Laparoscopic surgery has been shown to provide important advantages in comparison with open procedures in the treatment of several malignant diseases , such as less perioperative blood loss and faster patient recovery .
BACKGROUND	It also maintains similar results with regard to tumor resection margins and oncological long-term survival .
BACKGROUND	In gastric cancer the role of laparoscopic surgery remains unclear .
BACKGROUND	Current recommended treatment for gastric cancer consists of radical resection of the stomach , with a free margin of 5 to 6 cm from the tumor , combined with a lymphadenectomy .
BACKGROUND	The extent of the lymphadenectomy is considered a marker for radicality of surgery and quality of care .
BACKGROUND	Therefore , it is imperative that a novel surgical technique , such as minimally invasive total gastrectomy , should be non-inferior with regard to radicality of surgery and lymph node yield .
METHODS	The Surgical Techniques , Open versus Minimally invasive gastrectomy After CHemotherapy ( STOMACH ) study is a randomized , clinical multicenter trial .
METHODS	All adult patients with primary carcinoma of the stomach , in which the tumor is considered surgically resectable ( T1-3 , N0-1 , M0 ) after neo-adjuvant chemotherapy , are eligible for inclusion and randomization .
METHODS	The primary endpoint is quality of oncological resection , measured by radicality of surgery and number of retrieved lymph nodes .
METHODS	The pathologist is blinded towards patient allocation .
METHODS	Secondary outcomes include patient-reported outcomes measures ( PROMs ) regarding quality of life , postoperative complications and cost-effectiveness .
METHODS	Based on a non-inferiority model for lymph node yield , with an average lymph node yield of 20 , a non-inferiority margin of -4 and a 90 % power to detect non-inferiority , a total of 168 patients are to be included .
CONCLUSIONS	The STOMACH trial is a prospective , multicenter , parallel randomized study to define the optimal surgical strategy in patients with proximal or central gastric cancer after neo-adjuvant therapy : the conventional ` open ' approach or minimally invasive total gastrectomy .
BACKGROUND	This trial was registered on 28 April 2014 at Clinicaltrials.gov with the identifier NCT02130726 .

###24337734
OBJECTIVE	This study aims to investigate the role of fast-track surgery in preventing the development of postoperative delirium and other complications in elderly patients with colorectal carcinoma .
METHODS	A total of 240 elderly patients with colorectal carcinoma ( aged 70years ) undergoing open colorectal surgery was randomly assigned into two groups , in which the patients were managed perioperatively either with traditional or fast-track approaches .
METHODS	The length of hospital stay ( LOS ) and time to pass flatus were compared .
METHODS	The incidence of postoperative delirium and other complications were evaluated .
METHODS	Serum interleukin-6 ( IL-6 ) levels were determined before and after surgery .
RESULTS	The LOS was significantly shorter in the fast-track surgery ( FTS ) group than that in the traditional group .
RESULTS	The recovery of bowel movement ( as indicated by the time to pass flatus ) was faster in the FTS group .
RESULTS	The postoperative complications including pulmonary infection , urinary infection and heart failure were significantly less frequent in the FTS group .
RESULTS	Notably , the incidence of postoperative delirium was significantly lower in patients with the fast track therapy ( 4/117 , 3.4 % ) than with the traditional therapy ( 15/116 , 12.9 % ; p = 0.008 ) .
RESULTS	The serum IL-6 levels on postoperative days 1 , 2 , and 3 in patients with the fast-track therapy were significantly lower than those with the traditional therapy ( p < 0.001 ) .
CONCLUSIONS	Compared to traditional perioperative management , fast-track surgery decreases the LOS , facilitates the recovery of bowel movement , and reduces occurrence of postoperative delirium and other complications in elderly patients with colorectal carcinoma .
CONCLUSIONS	The lower incidence of delirium is at least partly attributable to the reduced systemic inflammatory response mediated by IL-6 .

###25602891
OBJECTIVE	We examined whether community translation of an effective evidence-based fall prevention program via standard monetary support can produce a community-wide reduction in fall injuries in older adults and evaluated whether an enhanced version with added technical support and capacity building amplified the fall reduction effect .
METHODS	We completed a randomized controlled community trial among adults aged 65 and older in ( 1 ) 10 control communities receiving no special resources or guidance on fall prevention , ( 2 ) 5 standard support communities receiving modest funding to implement Stepping On , and ( 3 ) 5 enhanced support communities receiving funding and technical support .
METHODS	The primary outcome was hospital inpatient and emergency department discharges for falls , examined with Poisson regression .
RESULTS	Compared with control communities , standard and enhanced support communities showed significantly higher community-wide reductions ( 9 % and 8 % , respectively ) in fall injuries from baseline ( 2007-2008 ) to follow-up ( 2010-2011 ) .
RESULTS	No significant difference was found between enhanced and standard support communities .
CONCLUSIONS	Population-based fall prevention interventions can be effective when implemented in community settings .
CONCLUSIONS	More research is needed to identify the barriers and facilitators that influence the successful adoption and implementation of fall prevention interventions into broad community practice .

###25483598
BACKGROUND	There is little evidence on the efficacy of glucocorticoid transnasal nebulization therapy in patients witheosinophilic chronic rhinosinusitis with nasal polyps ( CRSwNP ) .
OBJECTIVE	We sought to evaluate the immunologic and remodeling effects of budesonide transnasal nebulization in patients with eosinophilic CRSwNP .
METHODS	Sixty patients with eosinophilic CRSwNP were randomized to receive budesonide or placebo treatment for 14days by means of transnasal nebulization in a double-blind manner .
METHODS	Endoscopic polyp size scores ( maximum = 6 points , Kennedy score ) and visual analog scale scores for nasal symptoms were assessed before and after treatment .
METHODS	Similarly , polyp samples were evaluated for inflammatory cytokines , matrix metalloproteinases ( MMPs ) , and tissue inhibitors of metalloproteinases ( TIMPs ) by using an immunoassay ; collagen by using histochemistry ; eosinophils by using hematoxylin and eosin stain ; and T-cell subsets by using flow cytometry .
RESULTS	Budesonide transnasal nebulization significantly reduced polyp size compared with placebo ( mean difference between groups , -0.73 units ; 95 % CI , -1.15 to -0.32 units ; P = .002 ) and improved symptoms .
RESULTS	Polyp IL-5 and eotaxin expression decreased significantly , whereas TGF - and IL-10 expression increased .
RESULTS	Expression of IFN - and IL-17 was not altered .
RESULTS	Budesonide transnasal nebulization consistently reduced eosinophil infiltration and TH2 cell frequency and increased natural regulatory T-cell and type 1 regulatory T-cell frequencies .
RESULTS	Indices of remodeling , including albumin , MMP-2 , MMP-7 , MMP-8 , and MMP-9 , were significantly decreased , whereas collagen deposition and TIMP-1 , TIMP-2 , and TIMP-4 levels were significantly increased .
RESULTS	Budesonide transnasal nebulization did not suppress the hypothalamic-pituitary-adrenal axis or cause any serious side effects .
CONCLUSIONS	Short-term budesonide transnasal nebulization is an effective and safe treatment option in patients with eosinophilic CRSwNP , achieving clinical improvement by regulating remodeling , cytokine expression , and T-cell subset distribution .

###25439614
OBJECTIVE	To report 5-year results from a previously reported trial evaluating intravitreal 0.5 mg ranibizumab with prompt versus deferred ( for 24 weeks ) focal/grid laser treatment for diabetic macular edema ( DME ) .
METHODS	Multicenter , randomized clinical trial .
METHODS	Among participants from the trial with 3 years of follow-up who subsequently consented to a 2-year extension and survived through 5 years , 124 ( 97 % ) and 111 ( 92 % ) completed the 5-year visit in the prompt and deferred groups , respectively .
METHODS	Random assignment to ranibizumab every 4 weeks until no longer improving ( with resumption if worsening ) and prompt or deferred ( 24 weeks ) focal/grid laser treatment .
METHODS	Best-corrected visual acuity at the 5-year visit .
RESULTS	The mean change in visual acuity letter score from baseline to the 5-year visit was +7.2 letters in the prompt laser group compared with +9.8 letters in the deferred laser group ( mean difference,-2 .6 letters ; 95 % confidence interval,-5 .5 to +0.4 letters ; P = 0.09 ) .
RESULTS	At the 5-year visit in the prompt versus deferred laser groups , there was vision loss of 10 letters in 9 % versus 8 % , an improvement of 10 letters in 46 % versus 58 % , and an improvement of 15 letters in 27 % versus 38 % of participants , respectively .
RESULTS	From baseline to 5 years , 56 % of participants in the deferred group did not receive laser .
RESULTS	The median number of injections was 13 versus 17 in the prompt and deferral groups , including 54 % and 45 % receiving no injections during year 4 and 62 % and 52 % receiving no injections during year 5 , respectively .
CONCLUSIONS	Five-year results suggest focal/grid laser treatment at the initiation of intravitreal ranibizumab is no better than deferring laser treatment for 24 weeks in eyes with DME involving the central macula with vision impairment .
CONCLUSIONS	Although more than half of eyes in which laser treatment is deferred may avoid laser for at least 5 years , such eyes may require more injections to achieve these results when following this protocol .
CONCLUSIONS	Most eyes treated with ranibizumab and either prompt or deferred laser maintain vision gains obtained by the first year through 5 years with little additional treatment after 3 years .

###24604584
BACKGROUND	Postoperative pulmonary complications ( PPCs ) are the most commonly reported complications after esophagectomy .
BACKGROUND	The aim of this study was to examine the effect and feasibility of preoperative inspiratory muscle training-high intensity ( IMT-HI ) , and IMT-endurance ( IMT-E ) on the incidence of PPCs in patients following esophagectomy for esophageal cancer ( EC ) .
METHODS	A single-blind , randomized , clinical pilot study was conducted between 2009 and 2012 .
METHODS	Forty-five participants were assigned to either IMT-HI or IMT-E .
METHODS	Effectiveness was assessed by analyzing PPCs , length of hospital stay ( LOS ) , duration of mechanical ventilation , stay on the intensive care unit , and number of reintubations .
METHODS	Maximal inspiratory pressure and lung function changes were recorded pre - and post-training .
METHODS	Feasibility was assessed by IMT-related adverse events , training compliance , and patients ' satisfaction .
RESULTS	Thirty-nine patients could be analyzed , 20 patients in the IMT-HI arm and 19 patients in the IMT-E arm .
RESULTS	The incidence of PPCs differed significantly between groups and was almost three times lower for the IMT-HI group ( 4 vs. 11 patients ; p = 0.015 ) .
RESULTS	Other differences in favor of the IMT-HI group were LOS ( 13.5 vs. 18 days ; p = 0.010 ) and number of reintubations ( 0 vs. 4 patients ; p = 0.030 ) .
RESULTS	Both interventions proved to be equally feasible .
CONCLUSIONS	Preoperative IMT-HI showed to be a promising , effective , and feasible intervention to reduce PPCs in EC patients undergoing esophagectomy .
CONCLUSIONS	Further research with a larger sample size is recommended .

###24241092
BACKGROUND	Increased oxidative stress , inflammation , and malnutrition are present in hemodialysis patients and these factors exacerbate cardiovascular comorbidities .
BACKGROUND	Vitamin E and alpha-lipoic acid ( ALA ) may have a protective role against cardiovascular disease risk factors via anti-oxidative and anti-inflammatory properties .
BACKGROUND	The aim of this study was to evaluate the effect of ALA and vitamin E administration ( alone or combined ) on hemodialysis-induced stress oxidation , inflammation , and malnutrition .
METHODS	In a randomized placebo-controlled trial , we examined the effects of 2-month supplementation by vitamin E and ALA ( alone or combined ) on biomarkers of lipid peroxidation ( malondialdehyde ) , inflammation ( high-sensitivity C-Reactive protein and interleukin-6 ) , and malnutrition ( Subjective Global Assessment and body mass index ) in 85 hemodialysis patients receiving ALA ( 600 mg ) , vitamin E ( 400 IU ) , ALA and vitamin E , and placebo .
RESULTS	After supplementation , no significant changes were observed in malondialdehyde level ; however , there was a decrease in the ALA and vitamin E group during the period of the study .
RESULTS	Also , a nonsignificant decrease was seen in the high-sensitivity C-Reactive protein concentration of the interventional groups .
RESULTS	Supplementation of vitamin E with and without ALA significantly reduced interleukin-6 concentration .
RESULTS	A significant improvement was observed in malnutrition status of all groups .
CONCLUSIONS	Vitamin E and ALA supplementation , especially their combination , might improve inflammation and malnutrition status , which suggest it as a potential preventive strategy against CVD among end-stage renal disease patients .

###24856796
OBJECTIVE	To investigate the effect of dexmedetomidine on T helper 1 ( Th1 ) and T helper 2 ( Th2 ) cytokines and their ratio during and after surgery .
METHODS	Single-blinded , randomized , placebo-controlled clinical comparison study .
METHODS	Academic medical center .
METHODS	46 adult , ASA physical status 1 and 2 patients scheduled for laparoscopic cholecystectomy .
METHODS	Patients were randomized to two groups : the dexmedetomidine group ( n = 23 ) , in which dexmedetomidine was infused with a 1.0 g/kg loading dose followed by infusion of 0.5 g/kg/h ; or the saline group ( n = 23 ) .
METHODS	Interferon-gamma ( IFN-gamma ) and interleukin-4 ( IL-4 ) as Th1 and Th2 cytokines , respectively , were quantified three times : after induction of anesthesia ( T0 ) , at the end of peritoneal closure ( T1 ) , and 60 minutes after surgery ( T2 ) .
METHODS	The IFN-gamma/IL -4 ratio was then calculated .
RESULTS	The dexmedetomidine group displayed higher levels of IFN-gamma at T1 and T2 ( 42.30 pg/dL vs 6.91 pg/dL at T1 [ P = 0.025 ] ; 40.51 pg/dL vs 8.29 pg/dL at T2 [ P = 0.030 ] ) than the saline group .
RESULTS	The dexmedetomidine group was also associated with higher ratios of IFN-gamma/IL -4 ( 1.22 vs 0.32 , respectively , at T1 [ P = 0.012 ] ; 1.53 vs 0.13 , respectively , at T2 [ P = 0.012 ] ) .
CONCLUSIONS	Dexmedetomidine plays an immunomodulatory role , shifting the Th1/Th2 cytokine balance toward Th1 in patients with surgical and anesthetic stress .

###24471979
BACKGROUND	Animal studies report photodynamic therapy ( PDT ) to improve healing of excisional wounds ; the mechanism is uncertain and equivalent human studies are lacking .
OBJECTIVE	To explore the impact of methyl aminolaevulinate ( MAL ) - PDT on clinical and microscopic parameters of human cutaneous excisional wound healing , examining potential modulation through production of transforming growth factor ( TGF ) - isoforms .
METHODS	In 27 healthy older men ( 60-77 years ) , a 4-mm punch biopsy wound was created in skin of the upper inner arm and treated with MAL-PDT three times over 5 days .
METHODS	An identical control wound to the contralateral arm was untreated and both wounds left to heal by secondary intention .
METHODS	Wounds were re-excised during the inflammatory phase ( 7 days , n = 10 ) , matrix remodelling ( 3 weeks , n = 8 ) and cosmetic outcome/dermal structure ( 9 months , n = 9 ) .
METHODS	Production of TGF-1 , TGF-3 and matrix metalloproteinases ( MMPs ) was assessed by immunohistochemistry alongside microscopic measurement of wound size/area and clinical assessment of wound appearance .
RESULTS	MAL-PDT delayed re-epithelialization at 7 days , associated with increased inflammation .
RESULTS	However , 3 weeks postwounding , treated wounds were smaller with higher production of MMP-1 ( P = 001 ) , MMP-9 ( P = 004 ) and TGF-3 ( P = 003 ) .
RESULTS	TGF-1 was lower than control at 7 days and higher at 3 weeks ( both P = 003 ) .
RESULTS	At 9 months , MAL-PDT-treated wounds showed greater , more ordered deposition of collagen I , collagen III and elastin ( all P < 005 ) .
CONCLUSIONS	MAL-PDT increases MMP-1 , MMP-9 and TGF-3 production during matrix remodelling , ultimately producing scars with improved dermal matrix architecture .

###24313619
OBJECTIVE	Injections of human placental extract , which is known to play a role in skin regulation , have long been used for the treatment of skin wrinkles and non-healing wounds .
OBJECTIVE	Porcine placental extract ( PPE ) , an oral supplement , was recently developed for this purpose .
OBJECTIVE	The aim of this study was to assess whether PPE has a positive effect on the improvement of fine wrinkles below the eye in climacteric women .
METHODS	We first non-invasively measured wrinkle widths with a skin analyzer in a cross-section of 185 healthy adult Japanese women .
METHODS	Next , 44 climacteric women with mild or few climacteric symptoms were enrolled into an open-label , randomized , controlled study of the effect of PPE on wrinkle widths .
METHODS	A retrospective comparison of wrinkle widths in 123 climacteric women with climacteric symptoms with or without PPE treatment was also performed .
RESULTS	Wrinkle widths below the eye in women 30 years of age were significantly higher than in women 20-29 years of age .
RESULTS	Treatment with three capsules of PPE per day was significantly ( p < 0.05 ) effective in reducing wrinkle widths at 24 weeks compared with control subjects .
RESULTS	Retrospective analysis showed that subjects treated with three ( p < 0.05 ) and six ( p < 0.01 ) capsules of PPE per day observed a significant reduction in wrinkle widths compared with untreated subjects .
CONCLUSIONS	Oral PPE treatment is a possible option for improving the appearance of fine wrinkles below the eye in climacteric women .

###25229268
BACKGROUND	It is recommended to vaccinate pregnant women against influenza .
BACKGROUND	A possible impact on the immune expression of the fetus has never been studied .
BACKGROUND	We aim to study the immune signature in the upper airways and the incidence of infections in neonates born to mothers receiving Influenza A ( H1N1 ) pnd09 vaccination during pregnancy .
METHODS	One hundred and fifty-six women from the unselected Copenhagen Prospective Study on Asthma in Childhood ( COPSAC2010 ) received Influenza A ( H1N1 ) pnd09-vaccination during the 2009 pandemic .
METHODS	Fifty-one mothers received the vaccine during pregnancy and 105 after pregnancy ; 332 neonates of nonvaccinated mothers were included as secondary controls .
METHODS	Nasal mucosal lining fluid was sampled in 488 neonates and assessed for interleukin ( IL ) -12 p70 , IP-10 , interferon-gamma ( IFN ) - , tumor necrosis factor-alpha ( TNF ) - , MIP-1 , MCP-1 , MCP-4 , IL-4 , IL-5 , IL-13 , eotaxin-1 , eotaxin-3 , TARC , MDC , IL-17 , IL-1 , IL-8 , transforming growth factor beta ( TGF ) -1 , IL-10 and IL-2 .
METHODS	Infections were monitored the first year of life by daily diary cards and clinical controls .
RESULTS	Neonates of mothers vaccinated during pregnancy had significant up-regulation of TGF-1 [ ratio = 1.52 ( 1.22-1 .90 ) , P = 0.0002 ] , and corresponding down-regulation ( P < 0.05 ) of IL-12p70 , IFN - , IL-5 , eotaxin-1 , TARC , MDC , IL-8 in comparison to those vaccinated after pregnancy .
RESULTS	The lag-time from vaccination during pregnancy to assessment of the immune signature showed significant and positive association to up-regulation of TGF-1 levels ( P = 0.0003 ) and significant negative association to other mediators .
RESULTS	The study was not powered to study differences in the incidence of infections in early infancy which did not differ between the study groups .
CONCLUSIONS	Influenza A ( H1N1 ) pnd09 vaccination during pregnancy up-regulates TGF-1 and down-regulates key mediators of the protective immunity .

###25181946
BACKGROUND	Although glucocorticoids are widely used in the treatment of patients with early rheumatoid arthritis , the best dosage of glucocorticoids with regards to efficacy and safety is not known.The aim of the study ` Comparison of the efficacy and safety of two starting dosages of prednisolone in early active rheumatoid arthritis ' ( CORRA ) is to compare two standard glucocorticoid starting dosages and the non-use of glucocorticoids in the treatment of patients with early active rheumatoid arthritis on the background of the established ` anchor ' therapy with methotrexate .
METHODS	CORRA is an investigator-initiated , randomized , multicenter , double-blind , placebo-controlled trial with two treatment arms , starting with 60 mg or 10 mg prednisolone per day , tapered down to 5 mg prednisolone within eight weeks , and one placebo arm , each arm comprising 150 patients .
METHODS	The duration of the intervention is 12 weeks .
METHODS	In parallel , all patients will be treated with methotrexate ( usual dosage 15 mg/week ) .
METHODS	The primary efficacy endpoint is the progression of radiographic joint damage after one year compared to baseline .
METHODS	Important secondary endpoints are the percentage of patients in remission , patient global assessment of disease activity , and changes of functional capacity .
METHODS	Safety monitoring is performed.The statistical analysis is performed in three hierarchical steps .
METHODS	The first step is an analysis of covariance ( = 0.05 ) to compare the group with the initial prednisolone dosage of 60 mg and the placebo group .
METHODS	In case of a statistically significant result , the comparison of the group starting with 10 mg prednisolone with the placebo group will be performed as a second step ( = 0.05 ) .
METHODS	In case of superiority of the 10 mg prednisolone group versus the placebo group , the third step will be a non-inferiority test for the 10 mg prednisolone group versus the 60 mg prednisolone group ( = 0.025 ) .
CONCLUSIONS	The CORRA trial will yield information concerning the optimal glucocorticoid dosage schedule in the treatment of patients with early rheumatoid arthritis .
BACKGROUND	This trial was registered on 19 November 2013 at ClinicalTrials.gov .
BACKGROUND	NCT02000336 .

###25490802
OBJECTIVE	The aim of the current study was to investigate potential benefits of likelihood alarm systems ( LASs ) over binary alarm systems ( BASs ) in a multitask environment .
BACKGROUND	Several problems are associated with the use of BASs , because most of them generate high numbers of false alarms .
BACKGROUND	Operators lose trust in the systems and ignore alarms or cross-check all of them when other information is available .
BACKGROUND	The first behavior harms safety , whereas the latter one reduces productivity .
BACKGROUND	LASs represent an alternative , which is supposed to improve operators ' attention allocation .
METHODS	We investigated LASs and BASs in a dual-task paradigm with and without the possibility to cross-check alerts with raw data information .
METHODS	Participants ' trust in the system , their behavior , and their performance in the alert and the concurrent task were assessed .
RESULTS	Reported trust , compliance with alarms , and performance in the alert and the concurrent task were higher for the LAS than for the BAS .
RESULTS	The cross-check option led to an increase in alert task performance for both systems and a decrease in concurrent task performance for the BAS , which did not occur in the LAS condition .
CONCLUSIONS	LASs improve participants ' attention allocation between two different tasks and therefore lead to an increase in alert task and concurrent task performance .
CONCLUSIONS	The performance maximum is achieved when LAS is combined with a cross-check option for validating alerts with additional information .
CONCLUSIONS	The use of LASs instead of BASs in safety-related multitask environments has the potential to increase safety and productivity likewise .

###24661535
BACKGROUND	Excessive body weight , low physical activity and excessive sedentary time in youth are major public health concerns .
BACKGROUND	A new generation of video games , the ones that require physical activity to play the games -- i.e. active games -- may be a promising alternative to traditional non-active games to promote physical activity and reduce sedentary behaviors in youth .
BACKGROUND	The aim of this manuscript is to describe the design of a study evaluating the effects of a family oriented active game intervention , incorporating several motivational elements , on anthropometrics and health behaviors in adolescents .
METHODS	The study is a randomized controlled trial ( RCT ) , with non-active gaming adolescents aged 12-16 years old randomly allocated to a ten month intervention ( receiving active games , as well as an encouragement to play ) or a waiting-list control group ( receiving active games after the intervention period ) .
METHODS	Primary outcomes are adolescents ' measured BMI-SDS ( SDS = adjusted for mean standard deviation score ) , waist circumference-SDS , hip circumference and sum of skinfolds .
METHODS	Secondary outcomes are adolescents ' self-reported time spent playing active and non-active games , other sedentary activities and consumption of sugar-sweetened beverages .
METHODS	In addition , a process evaluation is conducted , assessing the sustainability of the active games , enjoyment , perceived competence , perceived barriers for active game play , game context , injuries from active game play , activity replacement and intention to continue playing the active games .
CONCLUSIONS	This is the first adequately powered RCT including normal weight adolescents , evaluating a reasonably long period of provision of and exposure to active games .
CONCLUSIONS	Next , strong elements are the incorporating motivational elements for active game play and a comprehensive process evaluation .
CONCLUSIONS	This trial will provide evidence regarding the potential contribution of active games in prevention of excessive weight gain in adolescents .
BACKGROUND	Dutch Trial register NTR3228 .

###24559009
BACKGROUND	Metabolic syndrome ( MetS ) is diagnosed by the detection of at least three criteria ( hypertriglyceridemia , low HDL-C , hypertension , obesity and altered fasting glucose ) .
BACKGROUND	Visceral fat excess would be the starting point for its development .
BACKGROUND	Scientific evidence supports hypocaloric diets - mediterranean or low fat diet and rich in complex carbohydrates diet included - as the best treatment to reduce fat mass ( FM ) , maximizing its impact by combining them with physical exercise ( PE ) .
BACKGROUND	However , the effects of these treatments on basal metabolic rate ( BMR ) of patients with MetS , are unknown .
OBJECTIVE	To study the effect of the hypocaloric diet - mediterranean or low fat diet - with or without PE on the BMR and body composition ( BC ) of adults with MetS .
METHODS	36 volunteers , MetS , both sexes , > 50 years , meeting the inclusion criteria .
METHODS	They were randomly assigned to a group of intervention ( 3 months ) of hypocaloric diet : mediterranean diet ( MED ) , low fat and rich in complex carbohydrates diet ( CHO ) and both combined with PE ( MEDE and CHOE respectively ) .
METHODS	Anthropometric data was taken ( weight , muscle mass ( MM ) and FM ) and BMR was determined by indirect calorimetry , before and after intervention .
RESULTS	The addition of PE to both hypocaloric treatments produced greater FM loss and weight loss than dieting alone , being this loss in CHOE > MEDE ( p < 0.05 ) .
RESULTS	These groups decreased the BMR after treatment being MEDE > CHOE ( p < 0.05 ) .
RESULTS	Mediterranean diet with or without PE lost MM ( p < 0.05 ) being MEDE > MED CONCLUSIONS : CHOE induces less reduction of BMR while supporting a better profile of BC than MEDE .

###24561570
OBJECTIVE	To determine the relation between thrombus aspiration ( TA ) and/or intra-lesion ( IL ) abciximab with pre-stent Thrombolysis In Myocardial Infarction ( TIMI ) flow grade and infarct size ( IS ) in patients with ST-elevation myocardial infarction ( STEMI ) undergoing primary percutaneous coronary intervention ( PCI ) .
RESULTS	The INFUSE-AMI trial randomised 452 patients with anterior STEMI to IL abciximab vs. no abciximab , and to manual TA vs. no TA .
RESULTS	The primary endpoint was cMRI-determined IS at 30 days .
RESULTS	Patients were classified according to pre-stent TIMI flow .
RESULTS	Complete data were available in 290 patients - 68 ( 25.2 % ) with pre-stent TIMI 0/1 flow , 47 ( 17.4 % ) with TIMI 2 flow and 175 ( 57.4 % ) with TIMI 3 flow .
RESULTS	Patients with pre-stent TIMI 3 flow had significantly lower IS ( 15.5 % [ 4.6 , 21.8 ] vs. 22.6 % [ 14.7 , 28.0 ] for TIMI 2 vs. 19.5 [ 14.4 , 27.8 ] for TIMI 0/1 , p < 0.0001 ) and fewer 30-day clinical events ( p = 0.03 ) .
RESULTS	Patients receiving TA with or without IL abciximab had the highest rate of pre-stent TIMI 3 flow ( p < 0.0001 ) and patients receiving both had the smallest IS ( 14.7 % vs. 17.3 % for the other three groups , p = 0.03 ) .
CONCLUSIONS	Optimisation of coronary flow prior to stent implantation may reduce infarct size and clinical events in STEMI patients undergoing primary PCI .

###24941430
BACKGROUND	Type 2 diabetes mellitus ( T2DM ) is a metabolic disease with debilitating effects on multiple organs .
BACKGROUND	The alveolar-capillary network in the lung is a large microvascular unit which may be affected by T2DM-associated microangiopathy .
METHODS	This retrospective study investigated whether type 2 diabetes mellitus ( T2DM ) affected pulmonary function .
METHODS	Of the 584 patients enrolled in the study , 292 had T2DM and 292 did not .
METHODS	Forced expiratory volume in one second ( FEV ) , forced vital capacity ( FVC ) , maximum voluntary ventilation ( MVV ) and total lung capacity ( TLC ) are values as percent of predicted , as well as FEV/FVC ratio which were values measured .
RESULTS	FEV , FVC , FEV/FVC ratio , MVV , and TLC were significantly lower in T2DM than in non-T2DM ( P-values < 0.010 ) .
RESULTS	Multiple linear regression analysis found that for the entire study population fasting plasma glucose levels was negatively associated with FEV , FVC , FEV/FVC ratio and maximum voluntary ventilation ( P-values < 0.030 ) .
RESULTS	Patients with T2DM were negatively associated with total lung capacity ( P-values = 0.025 ) .
RESULTS	Multiple linear regression analysis found for patients with T2DM that fasting plasma glucose was negatively associated with FEV , FVC , FEV/FVC ratio and maximum voluntary ventilation ( P-values < 0.020 ) .
RESULTS	In T2DM patient , height was negatively correlated with FEV and FVC ( all P-values < 0.020 ) , triglycerides were negatively correlated with FEV/FVC ratio ( P-values = 0.048 ) , and creatinine was negatively correlated with total lung capacity ( P-values = 0.017 ) .
CONCLUSIONS	In summary , T2DM is associated with impaired pulmonary function consistent with obstructive ventilation pattern and fasting plasma glucose is an independent risk factor of reduced pulmonary function .

###25259553
OBJECTIVE	The long-term outcome between laparoscopic cholecystectomy ( LC ) and minilaparotomy cholecystectomy ( MC ) with ultrasonic dissection ( UsD ) technique has not been compared in randomized trials .
OBJECTIVE	Therefore , we investigated the outcome after conventional LC and MC with UsD in 78 patients ( ClinicalTrials.gov Identifier : NCT0172340 ) .
METHODS	Initially 88 patients with non-complicated symptomatic gallstone disease were randomized into MC ( n = 44 ) or LC ( n = 44 ) over a period of 2 years ( 2010-2012 ) and 78 of them ( 89 % ) were reached for a follow-up interview at 12 months after the surgery .
RESULTS	Baseline parameters were similar in the two groups , and 1/44 MCs and 2/44 LCs were converted to open laparotomy .
RESULTS	The prevalence of chronic post-surgical pain ( CPSP ) one year after the procedure was quite similar in the two groups : 3/36 ( 8 % ) in the MC group and 2/42 ( 5 % ) in the LC group ( p = 0.502 ) .
RESULTS	Residual abdominal symptoms were common , but the proportion was similar in both groups ( 28 % in MC and 33 % in LC group , p = 0.665 ) .
RESULTS	Both groups were very satisfied with the cosmetic outcome ( numeric rating scale , p = 0.470 ) .
RESULTS	The Quality of life ( QoL ) improved 34/36 ( 94 % ) in the MC group and 33/42 ( 79 % ) in the LC group ( p = 0.046 ) and all patients in both groups were satisfied with the operation overall .
CONCLUSIONS	Day-case MC and LC patients have a quite similar one-year outcome with no significant difference regarding residual abdominal symptoms , cosmetic satisfaction , QoL or CPSP .

###24988195
OBJECTIVE	To describe the variation in household crowding and social mixing patterns in the African meningitis belt and to assess any association with self-reported recent respiratory symptoms .
METHODS	In 2010 , the African Meningococcal Carriage Consortium ( MenAfriCar ) conducted cross-sectional surveys in urban and rural areas of seven countries .
METHODS	The number of household members , rooms per household , attendance at social gatherings and meeting places were recorded .
METHODS	Associations with self-reported recent respiratory symptoms were analysed by univariate and multivariate regression models .
RESULTS	The geometric mean people per room ranged from 1.9 to 2.8 between Ghana and Ethiopia respectively .
RESULTS	Attendance at different types of social gatherings was variable by country , ranging from 0.5 to 1.5 per week .
RESULTS	Those who attended 3 or more different types of social gatherings a week ( frequent mixers ) were more likely to be older , male ( OR 1.27 , p < 0.001 ) and live in urban areas ( OR 1.45 , p < 0.001 ) .
RESULTS	Frequent mixing and young age , but not increased household crowding , were associated with higher odds of self-reported respiratory symptoms ( aOR 2.2 , p < 0.001 and OR 2.8 , p < 0.001 respectively ) .
RESULTS	A limitation is that we did not measure school and workplace attendance .
CONCLUSIONS	There are substantial variations in household crowding and social mixing patterns across the African meningitis belt .
CONCLUSIONS	This study finds a clear association between age , increased social mixing and respiratory symptoms .
CONCLUSIONS	It lays the foundation for designing and implementing more detailed studies of social contact patterns in this region .

###24352823
OBJECTIVE	It has been reported that even oneyear after total knee arthroplasty ( TKA ) , a relevant percentage of patients does not attain complete recovery and indicate unfavourable long-term pain outcome .
OBJECTIVE	We compared the clinical outcome of 33 patients undergoing TKA randomly assigned to the control or the pulsed electromagnetic field group ( I-ONE therapy ) .
METHODS	I-ONE therapy was administered postoperatively four hours per day for 60days .
METHODS	Patients were assessed before surgery and then at one , two and sixmonths postoperatively using international scores .
RESULTS	One month after TKA , pain , knee swelling and functional score were significantly better in the treated compared with the control group .
RESULTS	Pain was still significantly lower in the treated group at the six month follow-up .
RESULTS	Three years after surgery , severe pain and occasional walking limitations were reported in a significantly lower number of patients in the treated group .
CONCLUSIONS	Advantages deriving from early control of joint inflammation may explain the maintenance of results at follow-up .
CONCLUSIONS	I-ONE therapy should be considered an effective completion of the TKA procedure .

###24566756
OBJECTIVE	The objective of this study was to compare the perfusion index ( PI ) variability in premature infants with respiratory distress syndrome ( RDS ) following administration of two different natural surfactant preparations .
METHODS	This was a prospective study on 92 preterm infants with RDS .
METHODS	Patients were randomized into two groups .
METHODS	Group 1 ( n = 46 ) received beractant ; Group 2 ( n = 46 ) received poractant alfa .
METHODS	Oxygen saturation , PI , and heart rate were measured by Masimo Rainbow SET Radical-7 pulse oximeter ( Masimo Corp. , Irvine , CA ) before and after surfactant .
METHODS	The effects of the two treatment regimens on PI and oxygenation were compared .
RESULTS	Repeated doses were more needed in beractant group ( p = 0.04 ) .
RESULTS	Median oxygenation index ( OI ) before surfactant were similar , but improvement in OI was more prominent at 6th hour of surfactant in Group 2 ( p = 0.001 ) .
RESULTS	Both groups had similar preductal PI values before surfactant .
RESULTS	PI was higher at 6th hour of surfactant in Group 2 ( p = 0.001 ) .
RESULTS	Pulmonary hemorrhage , intraventricular hemorrhage , patent ductus arteriosus , necrotizing enterocolitis , and mortality were more frequent in infants whose PI values lower than 0.7 within the first 5 days of life ( p = 0.001 ) .
CONCLUSIONS	Poractant alfa resulted in more prominent improvement in PI and OI .
CONCLUSIONS	Low PI values measured at early postnatal period may predict poor clinical outcome in preterm infants with RDS .

###25282563
BACKGROUND	Atopic dermatitis ( atopic eczema ) is a chronic inflammatory skin disease that has reached epidemic proportions in children worldwide and is increasing in prevalence .
BACKGROUND	Because of the significant socioeconomic effect of atopic dermatitis and its effect on the quality of life of children and families , there have been decades of research focused on disease prevention , with limited success .
BACKGROUND	Recent advances in cutaneous biology suggest skin barrier defects might be key initiators of atopic dermatitis and possibly allergic sensitization .
OBJECTIVE	Our objective was to test whether skin barrier enhancement from birth represents a feasible strategy for reducing the incidence of atopic dermatitis in high-risk neonates .
METHODS	We performed a randomized controlled trial in the United States and United Kingdom of 124 neonates at high risk for atopic dermatitis .
METHODS	Parents in the intervention arm were instructed to apply full-body emollient therapy at least once per day starting within 3 weeks of birth .
METHODS	Parents in the control arm were asked to use no emollients .
METHODS	The primary feasibility outcome was the percentage of families willing to be randomized .
METHODS	The primary clinical outcome was the cumulative incidence of atopic dermatitis at 6 months , as assessed by a trained investigator .
RESULTS	Forty-two percent of eligible families agreed to be randomized into the trial .
RESULTS	All participating families in the intervention arm found the intervention acceptable .
RESULTS	A statistically significant protective effect was found with the use of daily emollient on the cumulative incidence of atopic dermatitis with a relative risk reduction of 50 % ( relative risk , 0.50 ; 95 % CI , 0.28-0 .9 ; P = .017 ) .
RESULTS	There were no emollient-related adverse events and no differences in adverse events between groups .
CONCLUSIONS	The results of this trial demonstrate that emollient therapy from birth represents a feasible , safe , and effective approach for atopic dermatitis prevention .
CONCLUSIONS	If confirmed in larger trials , emollient therapy from birth would be a simple and low-cost intervention that could reduce the global burden of allergic diseases .

###24593931
BACKGROUND	Fluralaner , a new molecular entity of the isoxazoline class , has potent insecticidal and acaricidal activity and can be safely administered orally to dogs .
METHODS	A randomized , investigator-blinded , multi-centered field study compared the flea - and tick-control efficacy for dogs over a 12-week period with either a single oral dose of Bravecto ( fluralaner ) formulated as a chewable tablet or with three sequential topical Frontline ( fipronil ) treatments .
METHODS	Individual dogs were the experimental unit for ticks and households were the experimental unit for fleas .
METHODS	A total of 108 tick-infested dogs were treated with Bravecto ( fluralaner ) and 54 tick-infested dogs were treated with Frontline ( fipronil ) .
METHODS	Dogs in 115 flea-infested households received Bravecto ( fluralaner ) and dogs in 61 flea-infested households received Frontline ( fipronil ) .
METHODS	Flea and tick counts were conducted on all dogs at weeks 2 , 4 , 8 , and 12 following initial treatment and efficacy was calculated as the mean percent reduction in tick or flea count at each time point compared with the mean pretreatment initiation count for each treatment group .
METHODS	Additionally , the percentages of tick-free and flea-free households were determined .
RESULTS	At weeks 2 , 4 , 8 , and 12 , Bravecto ( fluralaner ) flea-control efficacy in treated households was 99.2 % , 99.8 % , 99.8 % , and 99.9 % respectively , while Frontline ( fipronil ) efficacy was 94.1 % , 93.0 % , 96.0 % , and 97.3 % , respectively .
RESULTS	Bravecto ( fluralaner ) tick-control efficacy on treated dogs at weeks 2 , 4 , 8 , and 12 was 99.9 % , 99.9 % , 99.7 % , and 100 % , respectively , and Frontline ( fipronil ) tick efficacy was 97.6 % , 93.8 % , 100 % , and 100 % , respectively .
RESULTS	Of dogs showing clinical flea allergy dermatitis ( FAD ) signs at the study start , 85.7 % in the Bravecto ( fluralaner ) - treated group and 55.6 % in the Frontline ( fipronil ) - treated group were evaluated at each time point as showing no clinical signs of FAD until study completion .
CONCLUSIONS	Bravecto ( fluralaner ) administered once orally to dogs in a chewable tablet was highly effective for 12 weeks against fleas and ticks on privately-owned dogs and was significantly non-inferior ( ticks ) and superior ( fleas ) in comparison with topical Frontline ( fipronil ) administered 3 times sequentially .

###25456571
BACKGROUND	Cocaine has become one of the drugs of most concern in Switzerland , being associated with a wide range of medical , psychiatric and social problems .
BACKGROUND	Available treatment options for cocaine dependence are rare .
BACKGROUND	The study sought to compare combined prize-based contingency management ( prizeCM ) plus cognitive-behavioral therapy ( CBT ) to CBT alone in cocaine-dependent patients .
METHODS	Sixty cocaine-dependent patients participated in a randomized , controlled trial with two treatment conditions .
METHODS	The participants were randomly assigned to the experimental group ( EG ; n = 29 ) , who received CBT combined with prizeCM , or to the control group ( CG ; n = 31 ) , who received CBT only during 24 weeks .
METHODS	The primary outcome measures were retention , at least 3 consecutive weeks of cocaine abstinence , the maximum number of consecutive weeks of abstinence and proportions of cocaine-free urine samples during the entire 24-week and at 6-month follow-up .
RESULTS	Sixty-three percent of the participants completed the study protocol .
RESULTS	Participants in both groups significantly reduced cocaine use over time .
RESULTS	Overall , no difference in cocaine-free urine screens was found across the two treatment groups , except at weeks 8 , 9 , 10 , 17 and 21 in favor of the EG .
CONCLUSIONS	The addition of prizeCM to CBT seems to enhance treatment effects , especially in the early treatment period , supporting results from previous studies .
CONCLUSIONS	Both the combined intervention and CBT alone , led to significant reductions in cocaine use during treatment and these effects were sustained at 6-month follow-up .
CONCLUSIONS	These findings underline the importance in implementing CM and CBT interventions as treatment options for cocaine dependence in the European context .

###25604767
BACKGROUND	Integrated vector management strategies depend on local eco-bio-social conditions , community participation , political will and inter-sectorial partnership .
BACKGROUND	Previously identified risk factors for persistent Triatoma dimidiata infestation include the presence of rodents and chickens , tiled roofs , dirt floors , partial wall plastering and dog density .
METHODS	A community-based intervention was developed and implemented based on cyclical stakeholder and situational analyses .
METHODS	Intervention implementation and evaluation combined participatory action research and cluster randomized pre-test post-test experimental designs .
METHODS	The intervention included modified insecticide application , education regarding Chagas disease and risk factors , and participatory rodent control .
RESULTS	At final evaluation there was no significant difference in post-test triatomine infestation between intervention and control , keeping pre-test rodent and triatomine infestations constant .
RESULTS	Knowledge levels regarding Chagas disease and prevention practices including rodent control , chicken management and health service access increased significantly only in intervention communities .
RESULTS	The odds of nymph infection and rat infestation were 8.3 and 1.9-fold higher in control compared to intervention communities , respectively .
CONCLUSIONS	Vector control measures without reservoir control are insufficient to reduce transmission risk in areas with persistent triatomine infestation .
CONCLUSIONS	This integrated vector management program can complement house improvement initiatives by prioritizing households with risk factors such as tiled roofs .
CONCLUSIONS	Requirement for active participation and multi-sectorial coordination poses implementation challenges .

###24965739
OBJECTIVE	To examine whether Modic changes influence pain during a 1-year follow-up in patients with lumbar radicular pain .
METHODS	A total of 243 patients with lumbar radicular pain due to disc herniation were recruited from two hospitals in Norway and followed up at 6 weeks , 6 months , and 12 months .
METHODS	On baseline lumbar magnetic resonance images , two observers independently evaluated Modic changes ( types I-III ; craniocaudal size 0-3 ) .
METHODS	Outcomes were sensory pain ( McGill Pain Questionnaire ) , back and leg pain ( visual analogue scale , VAS ) .
METHODS	Association between Modic type and outcomes was explored with a mixed model and then by two-way analysis of variance ( ANOVA ) at each time point with Modic and treatment groups ( surgical , n = 126 ; nonsurgical , n = 117 ) as fixed factors , adjusted for disc degeneration , age , sex , smoking , and duration of radicular pain .
METHODS	Modic size was also analyzed using ANOVA .
RESULTS	Pain scores had decreased significantly at 1-year follow-up .
RESULTS	Modic type was significantly related to McGill sensory scores ( mixed model : p = 0.014-0 .026 ; ANOVA : p = 0.007 at 6 weeks ) , but not to VAS back pain or VAS leg pain scores .
RESULTS	At 6 weeks , the mean McGill sensory score was higher in Modic I than in Modic II-III patients ( p = 0.003 ) and in patients without Modic changes ( p = 0.018 ) .
RESULTS	Modic size L1-S1 was not associated with pain outcomes .
CONCLUSIONS	Patients with lumbar radicular pain have a substantial pain reduction during 1-year follow-up , but Modic type I changes may imply a slower initial decrease in sensory pain .

###24267260
OBJECTIVE	This cross-sectional study tested the hypothesis that treatment with the combination of Ezetimibe/Simvastatin ( Vytorin ) leads to broader changes in the expression levels of immunomodulatory genes as compared to Simvastatin monotherapy .
METHODS	Illumina 's GenomeStudio gene expression module was used to compare gene profiles of Vytorin and Simvastatin in the peripheral blood mononuclear cells of 20 hypercholesterolemic subjects .
RESULTS	The characteristics of the immunomodulatory genes , which were altered by Vytorin , differed from those genes which were altered by Simvastatin .
RESULTS	Vytorin mostly altered the expression levels of genes related to inflammation/oxidative stress ; it downregulated the NF-KappaB and upregulated the expression of anti-inflammatory cytokine , IL-10 , and anti-oxidant enzymes , GPX1 and SOD2 , but also upregulated the expression levels of genes involved in cellular activation , adhesion , and coagulation cascade , including VWF , F7 , PF4 , PF4V1 SELP , ITGB3 , ITGB5 .
RESULTS	Simvastatin mostly altered the expression levels of genes related to cellular apoptosis/proliferation .
RESULTS	It upregulated the expression levels of apoptosis-related genes APAF1 , BAX , IER3 , and CSF1R , and downregulated the expression levels of genes related to cellular proliferation , including PTN and CD69 .
RESULTS	Treatment with Vytorin combination therapy modulated lipid profile and serum levels of the C-reactive protein more effectively , than treatment with Simvastatin monotherapy .
CONCLUSIONS	The nature of the pleiotropic effects may play a role in Vytorin 's and Simvastatin 's clinical efficacies .

###24263115
BACKGROUND	The presence of hyponatremia has been perceived to increase the risk of adverse events on initiation of treatment with angiotensin-converting enzyme inhibition in heart failure patients .
BACKGROUND	The aim of this study was to investigate if baseline hyponatremia ( plasma Na ( + ) < 135mmol/L ) predicts development of hypotension and renal impairment in patients with myocardial infarction ( MI ) and left ventricular dysfunction ( LVD ) treated with angiotensin-converting enzyme inhibitors .
RESULTS	A retrospective analysis was performed with data from the Trandolapril Cardiac Evaluation ( TRACE ) a double-blind randomized study .
RESULTS	Plasma sodium levels were available in 1,731 patients , who were considered as the study population .
RESULTS	Patients 3-7days after MI with left LVD ( LVEF 0.35 ) , were randomized to trandolapril ( n = 876 ) or placebo ( n = 873 ) .
RESULTS	Baseline hyponatremia did not predict development of hypotension or worsening renal function after 1month in patients treated with trandolapril compared with placebo ( 12219.1 mm Hg vs 123.220.4 mm Hg [ P = .84 ] ; and creatinine clearance 57.421.4 mL/min vs 55.221.0 mL/min [ P = .8 ] ) .
RESULTS	There was no interaction between hyponatremia and the effect of trandolapril ( P = .68 ) .
CONCLUSIONS	Mild hyponatremia was not a contraindication for the initiation of treatment with angiotensin-converting enzyme inhibitors in patients with post-MI heart failure .

###25026745
BACKGROUND	Psoriasis is a chronic inflammatory dermatosis leading to the development of systemic inflammatory reaction .
BACKGROUND	Previous data indicated the coexistence of psoriasis and the occurrence of metabolic disorders , with the common background of both processes determined by a chronic inflammation .
BACKGROUND	The coexisting disorders , including type 2 diabetes , hypertension , heart ischemic disease , dislipidemia and obesity may have an important impact on intensity of psoriasis activity .
METHODS	The analysis comprised of 82 randomly matched patients with various clinical forms of psoriasis , aged 17 to 81 years .
METHODS	In patients PASI and BSA indexes , BMI value and laboratory parameters of metabolic status ( glucose and ureic acid levels , lipid fractions and CRP level in the serum ) were evaluated .
RESULTS	An average age in examined group was 54,3 years , an average time of presence of psoriasis symptoms was approximately 20 years .
RESULTS	An average PASI value was 21,4 ; an average BSA value was 39.7 % .
RESULTS	The coexistence of type 2 diabetes was found in 14.6 % of patients , hypertension in 42.7 % and heart ischemic disease in 17 % .
RESULTS	Particularly large group of examined patients comprised persons with overweight ( 34.1 % ) and obesity ( 30.5 % ) .
RESULTS	Positive correlation between BSA and body weight , BSA and BMI value , BSA and abdominal circumference as well as positive correlation between PASI and body weight , PASI and BMI value , PASI and abdominal circumference were observed .
RESULTS	Abnormal serum glucose levels were observed in 19.5 % persons , ureic acid level in 2.9 % , total cholesterol in 37.8 % LDL cholesterol in 48.8 % , and HDL cholesterol in 46.3 % .
RESULTS	CRP level was elevated in 43.9 % patients .
RESULTS	Positive correlation between BSA and ureic acid level , as well as PASI and ureic acid level was estimated .
RESULTS	No correlation between PASI and the other laboratory parameters was found .
CONCLUSIONS	The occurrence of metabolic syndrome is more common in patients with psoriasis in comparison to the general population .
CONCLUSIONS	The extent and severity of psoriatic lesions correlate with high body weight , BMI and the level of ureic acid .

###25213052
BACKGROUND	Although exhaled breath condensate ( EBC ) pH has been identified as an `` emerging '' biomarker of interest for asthma clinical trials , the clinical determinants of EBC pH remain poorly understood .
BACKGROUND	Other studies have associated acid reflux-induced respiratory symptoms , for example , cough , with transient acidification of EBC .
OBJECTIVE	We sought to determine the clinical and physiologic correlates of EBC acidification in a highly characterized sample of children with poorly controlled asthma .
OBJECTIVE	We hypothesized that ( 1 ) children with asymptomatic gastroesophageal reflux determined by 24-hour esophageal pH monitoring would have a lower EBC pH than children without gastroesophageal reflux , ( 2 ) treatment with lansoprazole would alter EBC pH in those children , and ( 3 ) EBC acidification would be associated with increased asthma symptoms , poorer asthma control and quality of life , and increased formation of breath nitrogen oxides ( NOx ) .
METHODS	A total of 110 children , age range 6 to 17 years , with poor asthma control and esophageal pH data enrolled in the Study of Acid Reflux in Children with Asthma ( NCT00442013 ) were included .
METHODS	Children submitted EBC samples for pH and NOx measurement at randomization and at study weeks 8 , 16 , and 24 .
RESULTS	Serial EBC pH measurements failed to distinguish asymptomatic gastroesophageal reflux and was not associated with breath NOx formation .
RESULTS	EBC pH also did not discriminate asthma characteristics such as medication and health care utilization , pulmonary function , and asthma control and quality of life both at baseline and across the study period .
CONCLUSIONS	Despite the relative ease of EBC collection , EBC pH as a biomarker does not provide useful information of children with asthma who were enrolled in asthma clinical trials .

###24682069
OBJECTIVE	No therapy directed against diabetes has been shown to unequivocally reduce the excess risk of cardiovascular complications .
OBJECTIVE	Aleglitazar is a dual agonist of peroxisome proliferator-activated receptors with insulin-sensitizing and glucose-lowering actions and favorable effects on lipid profiles .
OBJECTIVE	To determine whether the addition of aleglitazar to standard medical therapy reduces cardiovascular morbidity and mortality among patients with type 2 diabetes mellitus and a recent acute coronary syndrome ( ACS ) .
METHODS	AleCardio was a phase 3 , multicenter , randomized , double-blind , placebo-controlled trial conducted in 720 hospitals in 26 countries throughout North America , Latin America , Europe , and Asia-Pacific regions .
METHODS	The enrollment of 7226 patients hospitalized for ACS ( myocardial infarction or unstable angina ) with type 2 diabetes occurred between February 2010 and May 2012 ; treatment was planned to continue until patients were followed-up for at least 2.5 years and 950 primary end point events were positively adjudicated .
METHODS	Randomized in a 1:1 ratio to receive aleglitazar 150 g or placebo daily .
METHODS	The primary efficacy end point was time to cardiovascular death , nonfatal myocardial infarction , or nonfatal stroke .
METHODS	Principal safety end points were hospitalization due to heart failure and changes in renal function .
RESULTS	The trial was terminated on July 2 , 2013 , after a median follow-up of 104 weeks , upon recommendation of the data and safety monitoring board due to futility for efficacy at an unplanned interim analysis and increased rates of safety end points .
RESULTS	A total of 3.1 % of patients were lost to follow-up and 3.2 % of patients withdrew consent .
RESULTS	The primary end point occurred in 344 patients ( 9.5 % ) in the aleglitazar group and 360 patients ( 10.0 % ) in the placebo group ( hazard ratio , 0.96 [ 95 % CI , 0.83-1 .11 ] ; P = .57 ) .
RESULTS	Rates of serious adverse events , including heart failure ( 3.4 % for aleglitazar vs 2.8 % for placebo , P = .14 ) , gastrointestinal hemorrhages ( 2.4 % for aleglitazar vs 1.7 % for placebo , P = .03 ) , and renal dysfunction ( 7.4 % for aleglitazar vs 2.7 % for placebo , P < .001 ) were increased .
CONCLUSIONS	Among patients with type 2 diabetes and recent ACS , use of aleglitazar did not reduce the risk of cardiovascular outcomes .
CONCLUSIONS	These findings do not support the use of aleglitazar in this setting with a goal of reducing cardiovascular risk .
BACKGROUND	clinicaltrials.gov Identifier : NCT01042769 .

###24359122
BACKGROUND	Pressure ulcers ( PrUs ) are ischemic wounds in the skin and underlying tissues caused by long-standing pressure force over an external bone or cartilaginous surface .
BACKGROUND	PrUs are an important challenge for the overall health system because can prolong patient hospitalization and reduce quality of life .
BACKGROUND	Moreover , 95 % of PrUs are avoidable , suggesting they are caused by poor quality care assistance .
BACKGROUND	PrUs are also costly , increasing national costs .
BACKGROUND	For example , they represent about 5 % of overall annual health expenses in Spain .
BACKGROUND	Stages I and II PrUs have a combined prevalence of 65 % .
BACKGROUND	According main clinical guidelines , stage II PrUs ( PrU-IIs ) are usually treated by applying special dressings ( polyurethane or hydrocolloid ) .
BACKGROUND	However , little scientific evidence regarding their efficacy has been identified in scientific literature .
BACKGROUND	Our aim is to assess the comparative efficacy of adhesive polyurethane foam and hydrocolloid dressings in the treatment of PrU-IIs in terms of healed ulcer after 8 weeks of follow-up .
METHODS	This paper describes the development and evaluation protocol of a randomized clinical trial of two parallel treatment arms .
METHODS	A total of 820 patients with at least 1 PrU-II will be recruited from primary health care and home care centers .
METHODS	All patients will receive standardized healing procedures and preventive measures ( e.g. positional changes and pressure-relieving support surfaces ) , following standardized procedures .
METHODS	The main outcome will be the percentage of wounds healed after 8 weeks .
METHODS	Secondary outcomes will include cost-effectiveness , as evaluated by cost per healed ulcer and cost per treated patient and safety evaluated by adverse events .
CONCLUSIONS	This trial will address the hypothesis that hydrocolloid dressings will heal at least 10 % more stage II PrUs and be more cost-effective than polyurethane foam dressings after 8 weeks .
BACKGROUND	This trial has been registered with controlled-trials number ISCRCTN57842461 and EudraCT 2012-003945-14 .

###25480528
BACKGROUND	Despite the widespread use of external ventricular drainage , revision rates , and associated complications are reported between 10 and 40 % .
BACKGROUND	Current available image-guided techniques using stereotaxy , endoscopy , or ultrasound for catheter placements remain time-consuming techniques .
BACKGROUND	Recently , a smartphone-assisted guide with high precision has been described .
BACKGROUND	The development of an easy-to-use , portable , image-guided system could reduce the need for multiple passes and improve the rate of accurate catheter placement .
BACKGROUND	This study aims to prospectively compare in a randomized controlled manner the accuracy of the freehand pass technique versus an easy-to-use , portable , adjustable guiding device for ventriculostomy catheter placement .
METHODS	This is a single center , prospective , randomized trial with a blinded endpoint ( ventricular catheter tip location ) assessment .
METHODS	Adult patients with the indication for ventriculostomy , as proven by computed tomography ( CT ) , will be randomly assigned to the treatment group or the control group .
METHODS	For patients in the treatment group , ventriculostomy will be performed using an adjustable guiding device and DICOM ( Digital Imaging and Communications in Medicine ) image-reading software assistance ( for example , using a mini-tablet ) based on preoperative CT imaging.Patients in the control group will receive standard freehand ventriculostomy using anatomical landmarks .
METHODS	The catheter may be placed for external drainage or internal ( ventriculoperitoneal ) shunting in both groups .
METHODS	The primary outcome measure is the rate of correct placements of the ventricular catheter , defined as a score of 1 to 3 on grading system for catheter tip location on a postoperative CT scan .
METHODS	Participants will be followed for the duration of hospital stay , an expected average of two weeks .
METHODS	The primary outcome will be determined by one of the authors blinded to the treatment allocation .
METHODS	We aim to include 236 patients in three years .
METHODS	Secondary outcome measures include : frequency of placements required , frequency of completed placements within the ventricle of the perforated part of the catheter tip , frequency of very early and early shunt failures ( revision of the ventricular drainage within 24 hours and within the hospital stay ) , frequency and percentage of complications ( procedure-related and nonsurgical ) at discharge .
CONCLUSIONS	This is the study design of a single center , prospective , randomized controlled trial to investigate whether guided ventriculostomy is superior to the standard freehand technique .
CONCLUSIONS	One strength of this study is the prospective , randomized , interventional type of study testing a new easy-to-handle guided versus freehand ventricular catheter placement .
CONCLUSIONS	A second strength of this study is that the power calculation is based on catheter accuracy using an available grading system for catheter tip location , and is calculated with the use of recent study results of our own population , supported by data from prominent studies .
BACKGROUND	Clinicaltrials.gov identifier : NCT02048553 ( registered on 28 January 2014 ) .

###24339687
OBJECTIVE	To compare visual acuity with two visual acuity charts in preschool children .
METHODS	Visual acuity measurement with Lea symbols and Bailey-Lovie tumbling E chart was performed on children between 3 and 6 years of age .
METHODS	Visual acuity data from the two charts were analyzed with Bland-Altman plot to determine the limits of agreement .
METHODS	The Wilcoxon signed test was performed in children aged 3-4 years and in children aged 5-6 years separately to evaluate the influence of age .
METHODS	The inter-eye difference between the two charts were further analyzed with the paired t-test .
METHODS	A p value > 0.05 was considered statistically significant .
RESULTS	A total of 47 children were enrolled for the study .
RESULTS	The average logarithm of the Minimum Angle of Resolution ( LogMAR ) monocular visual acuity with Lea symbols ( 0.17 0.13 ) was better than the Bailey-Lovie tumbling E chart ( 0.22 0.14 ) .
RESULTS	The mean difference between Bailey-Lovie tumbling E chart and Lea symbol chart was 0.05 0.12 in logMAR units .
RESULTS	A second analysis eliminating outliers showed the same result but lower differences ( n = 43 , 0.05 0.05 logMAR units ) .
RESULTS	Visual acuity results between the two charts in children aged 3-4 years showed a significant difference ( p = 0.000 ) , but not for children aged 5-6 years ( p = 0.059 ) .
RESULTS	Inter-eye differences between the two charts was not statistically significant ( p = 0.77 ) .
CONCLUSIONS	Bailey-Lovie tumbling E chart is comparable to the Lea symbols chart in pre-school children .
CONCLUSIONS	But preference should be given to Lea symbols for children aged 3-4 years as the symbols are more familiar than a directional test for this age group .

###25648969
BACKGROUND	Local analgesic injections are commonly used for pain relief after shoulder surgery .
BACKGROUND	The aim of this study was to compare the efficacy of local injections administered in the glenohumeral joint , the subacromial space , or both locations after arthroscopic rotator cuff repair .
METHODS	Between March 2011 and December 2011 , 121 consecutive patients who had undergone arthroscopic rotator cuff repair surgery were enrolled in the study and all patients were randomly allocated to 3 groups .
METHODS	In group 1 , 40 patients received a postoperative glenohumeral injection of bupivacaine ( 20mL ) and lidocaine ( 10mL ) .
METHODS	In group 2 , 42 patients received the same postoperative injection , but it was administered in the subacromial space .
METHODS	In group 3 , 39 patients received the same amount of local anesthesia but with half injected in the glenohumeral joint and half in the subacromial space .
METHODS	The visual analog scale was used to assess pain intensity before surgery and at postoperative hours 1 , 2 , 6 , 12 , and 24 .
METHODS	Demerol was used as a postinjection rescue analgesic , and the total number of administrations was recorded at each time point .
RESULTS	There were no significant differences between groups in patient age , sex , or rotator cuff tear size ( P > .05 ) .
RESULTS	The visual analog scale scores for pain between each group were not significantly different at any time point , including before surgery ( P > .05 ) .
RESULTS	In addition , the amount of supplementary analgesic administered was not significantly different between the groups ( P > .05 ) .
CONCLUSIONS	Injection of local analgesics after arthroscopic rotator cuff repair relieves postoperative pain regardless of the injection location .

###25063725
OBJECTIVE	To assess the efficacy and safety of early , noninvasive inhaled nitric oxide ( iNO ) therapy in premature newborns who do not require mechanical ventilation .
METHODS	We performed a multicenter randomized trial including 124 premature newborns who required noninvasive supplemental oxygen within the first 72 hours after birth .
METHODS	Newborns were stratified into 3 different groups by birth weight ( 500-749 , 750-999 , 1000-1250 g ) prior to randomization to iNO ( 10 ppm ) or placebo gas ( controls ) until 30 weeks postmenstrual age .
METHODS	The primary outcome was a composite of death or bronchopulmonary dysplasia ( BPD ) at 36 weeks postmenstrual age .
METHODS	Secondary outcomes included the need for and duration of mechanical ventilation , severity of BPD , and safety outcomes .
RESULTS	There was no difference in the incidence of death or BPD in the iNO and placebo groups ( 42 % vs 40 % , P = .86 , relative risk = 1.06 , 0.7-1 .6 ) .
RESULTS	BPD severity was not different between the treatment groups .
RESULTS	There were no differences between the groups in the need for mechanical ventilation ( 22 % vs 23 % ; P = .89 ) , duration of mechanical ventilation ( 9.7 vs 8.4 days ; P = .27 ) , or safety outcomes including severe intracranial hemorrhage ( 3.4 % vs 6.2 % , P = .68 ) .
CONCLUSIONS	We found that iNO delivered noninvasively to premature infants who have not progressed to early respiratory failure is a safe treatment , but does not decrease the incidence or severity of BPD , reduce the need for mechanical ventilation , or alter the clinical course .

###24874565
BACKGROUND	Foods that are high in dietary fiber can promote satiety , but previous studies report conflicting results .
OBJECTIVE	The objective was to determine differences in satiety response to three conditions ( 10g oat bran , 10g barley bran and a low fiber condition ) consumed at dinner and breakfast .
OBJECTIVE	In addition , we compared energy intake at an ad libitum lunch after consumption of the breakfast bars .
METHODS	Randomized , double-blind crossover study .
METHODS	42 normal weight women .
METHODS	Women consumed a dinner food bar from one of the three conditions the evening before testing .
METHODS	On test mornings , fasted women consumed the corresponding breakfast food bar with their choice of coffee , tea or water .
METHODS	An ad libitum pizza lunch was served 4 hours after breakfast .
METHODS	Visual analogue scales ( VAS ) were used to assess satiety at baseline , 15 , 30 , 45 , 60 , 90 , 120 , 180 and 240 minutes .
METHODS	Energy intake was assessed by an ad libitum pizza lunch ( 4 hours after breakfast ) and 24-hour energy intake was measured by a food diary .
METHODS	Treatments were compared using the mixed-effects linear models .
METHODS	Outcomes are reported as mean SEM .
RESULTS	There were no significant differences among conditions on any of the satiety scales and no significant differences among conditions in energy consumed at lunch or over 24 hours .
RESULTS	The fiber bars were well tolerated and no significant differences were found for gastrointestinal tolerance .
CONCLUSIONS	Our results do not support an effect of bran fibers on satiety above a low fiber control .
CONCLUSIONS	We acknowledge results of this study may be intricately tied to the choice of a single pizza lunch , as other ad libitum meal options could have resulted in different outcomes .

###25270629
OBJECTIVE	The -1 receptor ( Sig-1R ) agonist cutamesine ( SA4503 ) enhanced functional recovery after experimental stroke with a treatment initiation window of 48 hours and chronic treatment for 28 days .
OBJECTIVE	We conducted a phase 2 clinical trial exploring the safety , tolerability , dose range , and functional effects of cutamesine in patients with ischemic stroke .
METHODS	Subjects were randomized between 48 and 72 hours after stroke to receive cutamesine 1 mg/d , 3 mg/d , or placebo for 28 days .
METHODS	Effects on safety and function were assessed at baseline , at end of treatment ( day 28 ) , and at end of follow-up ( day 56 ) .
RESULTS	In 60 patients , treatment with both cutamesine dosages was safe and well tolerated without significant differences in numbers of treatment emergent or serious adverse events .
RESULTS	No significant effect was observed on the primary efficacy measure ( change in National Institutes of Health Stroke Scale from baseline to day 56 ) or modified Rankin Scale and Barthel Index scores .
RESULTS	Post hoc analysis of moderately and severely affected patients ( baseline National Institutes of Health Stroke Scale , 7 and 10 ) showed greater National Institutes of Health Stroke Scale improvements in the 3 mg/d cutamesine group when compared with placebo ( P = 0.034 and P = 0.038 , respectively ) .
RESULTS	A trend toward a higher proportion being able to complete a 10m timed walk was observed for cutamesine-treated subjects .
CONCLUSIONS	Cutamesine was safe and well tolerated at both dosage levels .
CONCLUSIONS	Although no significant effects on functional end points were seen in the population as a whole , greater improvement in National Institutes of Health Stroke Scale scores among patients with greater pretreatment deficits seen in post hoc analysis warrants further investigation .
CONCLUSIONS	Additional studies should focus on the patient population with moderate-to-severe stroke .
BACKGROUND	http://www.clinicaltrials.gov/show/NCT00639249 .
BACKGROUND	Unique identifier : NCT00639249 .
BACKGROUND	The EudraCT number is 2007-004840-60 ( https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-004840-60/GB ) .

###25667151
BACKGROUND	Frailty is a major concern due to its costly and widespread consequences , yet evidence of effective interventions to delay or reduce frailty is lacking .
BACKGROUND	Our previous study found that a multifactorial intervention was feasible and effective in reducing frailty in older people who were already frail .
BACKGROUND	Identifying and treating people in the pre-frail state may be an effective means to prevent or delay frailty .
BACKGROUND	This study describes a randomised controlled trial that aims to evaluate the effectiveness of a multifactorial intervention on development of frailty in older people who are pre-frail .
METHODS	A single centre randomised controlled trial with concealed allocation , assessor blinding and intention-to-treat analysis .
METHODS	Two hundred and thirty people aged above 70 who meet the Cardiovascular Health Study frailty criteria for pre-frailty , reside in the community and are without severe cognitive impairment will be recruited .
METHODS	Participants will be randomised to receive a multifactorial intervention or usual care .
METHODS	The intervention group will receive a 12-month interdisciplinary intervention targeting identified characteristics of frailty and problems identified during geriatric assessment .
METHODS	Participants will be followed for a 12-month period .
METHODS	Primary outcome measures will be degree of frailty measured by the number of Cardiovascular Health Study frailty criteria present , and mobility measured with the Short Physical Performance Battery .
METHODS	Secondary outcomes will include measures of mobility , mood and use of health and community services .
BACKGROUND	The study was approved by the Northern Sydney Local Health District Health Research Ethics Committee ( 1207-213M ) .
BACKGROUND	The findings will be disseminated through scientific and professional conferences , and in peer-reviewed journals .
BACKGROUND	Australian New Zealand Clinical Trials Registry : ACTRN12613000043730 .

###25823187
OBJECTIVE	To assess the effect of aerobic exercise training on maternal and neonatal outcome
METHODS	The case-control study was conducted between January and July , 2011 .
METHODS	It was approved by the Research Ethics Committee of Toyserkan Azad University , and data was collected at prenatal clinics and delivery centres located in Hamedan , Iran .
METHODS	It comprised 80 pregnant women between 20-26 weeks of gestation randomly assigned to two equal and matching groups of cases and controls .
METHODS	The intervention group did exercise continuously on a bicycle ergometre for 15 minutes , three times a week ; the intensity being 50-60 % of maximal heart rate .
METHODS	The control group did not do any exercise training .
METHODS	All information was obtained from the clinics , delivery centres , and from the reports of delivery room midwives .
RESULTS	No statistically significant difference was found between the two groups in gestational weight gain , pregnancy length , mode of delivery , first and second stage of labour , perineal tear , and 1st and 5th min Apgar score .
RESULTS	Mean neonatal weight was significantly less in the intervention group than the control group ( p < 0.001 ) .
CONCLUSIONS	Exercising on a bicycle ergometer during pregnancy seems to be safe for the mother and the neonate .

###24835623
OBJECTIVE	To determine patient independency , health-related and disease-specific quality of life ( QOL ) , gait pattern , and muscle strength in patients after salvage arthroplasty for failed internal fixation of a femoral neck fracture .
METHODS	Secondary cohort study to a randomized controlled trial .
METHODS	Multicenter trial in the Netherlands , including 14 academic and nonacademic hospitals .
METHODS	Patients after salvage arthroplasty for failed internal fixation of a femoral neck fracture were studied .
METHODS	A comparison was made with patients who healed uneventfully after internal fixation .
METHODS	None ( observatory study ) .
METHODS	Patient characteristics , SF-12 , and Western Ontario McMaster osteoarthritis index scores were collected .
METHODS	Gait parameters were measured using plantar pressure measurement .
METHODS	Maximum isometric forces of the hip muscles were measured using a handheld dynamometer .
METHODS	Differences between the fractured and contralateral leg were calculated .
METHODS	Groups were compared using univariate analysis .
RESULTS	Of 248 internal fixation patients ( median age , 72 years ) , salvage arthroplasty was performed in 68 patients ( 27 % ) .
RESULTS	Salvage arthroplasty patients had a significantly lower Western Ontario McMaster osteoarthritis index score ( median , 73 vs. 90 ; P = 0.016 ) than patients who healed uneventfully after internal fixation .
RESULTS	Health-related QOL ( SF-12 ) and patient independency did not differ significantly between the groups .
RESULTS	Gait analysis showed a significantly impaired progression of the center of pressure in the salvage surgery patients ( median ratio , -8.9 vs. 0.4 , P = 0.013 ) and a significant greater loss of abduction strength ( median , -25.4 vs. -20.4 N , P = 0.025 ) .
CONCLUSIONS	Despite a similar level of dependency and QOL , salvage arthroplasty patients have inferior functional outcome than patients who heal after internal fixation of a femoral neck fracture .
METHODS	Therapeutic level III .

###25882376
BACKGROUND	Among patients with acute ischemic stroke due to occlusions in the proximal anterior intracranial circulation , less than 40 % regain functional independence when treated with intravenous tissue plasminogen activator ( t-PA ) alone .
BACKGROUND	Thrombectomy with the use of a stent retriever , in addition to intravenous t-PA , increases reperfusion rates and may improve long-term functional outcome .
METHODS	We randomly assigned eligible patients with stroke who were receiving or had received intravenous t-PA to continue with t-PA alone ( control group ) or to undergo endovascular thrombectomy with the use of a stent retriever within 6 hours after symptom onset ( intervention group ) .
METHODS	Patients had confirmed occlusions in the proximal anterior intracranial circulation and an absence of large ischemic-core lesions .
METHODS	The primary outcome was the severity of global disability at 90 days , as assessed by means of the modified Rankin scale ( with scores ranging from 0 [ no symptoms ] to 6 [ death ] ) .
RESULTS	The study was stopped early because of efficacy .
RESULTS	At 39 centers , 196 patients underwent randomization ( 98 patients in each group ) .
RESULTS	In the intervention group , the median time from qualifying imaging to groin puncture was 57 minutes , and the rate of substantial reperfusion at the end of the procedure was 88 % .
RESULTS	Thrombectomy with the stent retriever plus intravenous t-PA reduced disability at 90 days over the entire range of scores on the modified Rankin scale ( P < 0.001 ) .
RESULTS	The rate of functional independence ( modified Rankin scale score , 0 to 2 ) was higher in the intervention group than in the control group ( 60 % vs. 35 % , P < 0.001 ) .
RESULTS	There were no significant between-group differences in 90-day mortality ( 9 % vs. 12 % , P = 0.50 ) or symptomatic intracranial hemorrhage ( 0 % vs. 3 % , P = 0.12 ) .
CONCLUSIONS	In patients receiving intravenous t-PA for acute ischemic stroke due to occlusions in the proximal anterior intracranial circulation , thrombectomy with a stent retriever within 6 hours after onset improved functional outcomes at 90 days .
CONCLUSIONS	( Funded by Covidien ; SWIFT PRIME ClinicalTrials.gov number , NCT01657461 . )

###24967526
BACKGROUND	Medication nonadherence is a common problem , resulting in significant human and economic cost , which can be a challenge to identify and resolve in practice .
BACKGROUND	Adherence tools have been developed to assist health care providers with managing medication nonadherence ; however , there is a need to develop a literature base for using adherence tools effectively .
OBJECTIVE	To ( a ) describe the experiences and perspectives of pharmacists and student pharmacists using the Adherence Estimator ( AE ) and Drug Adherence Work-up ( DRAW ) tools and ( b ) describe medication nonadherence issues identified via use of the AE and DRAW tools in community pharmacies and outpatient clinics .
METHODS	A practice-based study involving 6 primary care clinics and 4 community pharmacies in Iowa and Michigan was conducted .
METHODS	Each adherence tool was administered approximately 20 times by pharmacists or student pharmacists to patients at each site , using a crossover design with randomization to the initial tool .
METHODS	Sites determined how to incorporate tools into workflow and how to select patients .
METHODS	Data from completed tools were analyzed descriptively .
METHODS	Data from an online survey completed by tool administrators about their experiences and suggestions were analyzed thematically .
RESULTS	Sites submitted 209 AE and 179 DRAW tools .
RESULTS	Half of patients with a completed AE had at least 1 medication of medium or high risk of nonadherence , and 19 % had at least 1 medication of high risk .
RESULTS	For DRAW , 82 % of patients reported at least 1 yes answer for reasons for nonadherence , and 58 % reported 2 .
RESULTS	On average , the AE tool took 6.9 minutes , and the DRAW tool took 9.3 minutes .
RESULTS	Forty-four surveys were submitted ( 20 community and 24 clinic ) .
RESULTS	Two themes emerged from the open-ended responses : tool benefits and translating tools into practice .
RESULTS	While the tools were useful for identifying specific reasons for nonadherence and promoting dialogue , they required additional time and effort from both patients and pharmacists .
RESULTS	Health literacy , patient reluctance to discuss nonadherence , AE scaling , and DRAW length were voiced as concerns .
CONCLUSIONS	Both tools were useful for uncovering specific reasons for medication nonadherence in 5-10 minute encounters , but barriers exist to incorporating such tools into busy workflows .

###24350806
BACKGROUND	Prior telemonitoring trials of blood pressure and blood glucose have shown improvements in blood pressure and glycemic targets .
BACKGROUND	However , implementation of telemonitoring in primary care practices may not yield the same results as research trials with extra resources and rigid protocols .
BACKGROUND	In this study we examined the process of implementing home telemonitoring of blood glucose and blood pressure for patients with diabetes in six primary care practices .
METHODS	Grounded theory qualitative analysis was conducted in parallel with a randomized controlled effectiveness trial of home telemonitoring .
METHODS	Data included semistructured interviews with 6 nurse care coordinators and 12 physicians in six participating practices and field notes from exit interviews with 93 of 108 randomized patients .
RESULTS	The three stakeholder groups ( patients , nurse care coordinators , and physicians ) exhibited some shared themes and some unique to the particular stakeholder group .
RESULTS	Major themes were that practices should ( 1 ) understand the capabilities and limitations of the technology and the willingness of patient and physician stakeholders to use it , ( 2 ) understand the workflow , flow of information , and human factors needed to optimize use of the technology , ( 3 ) engage and prepare the physicians , and ( 4 ) involve the patient in the process .
RESULTS	Although there was enthusiasm for a patient-centered medical home model that included between-visit telemonitoring , there was concern about the support and resources needed to provide this service to patients .
CONCLUSIONS	As with many technology interventions , careful consideration of workflow and information flow will help enable effective implementations .

###24237916
BACKGROUND	Because smoking has a profound impact on socioeconomic disparities in illness and death , it is crucial that vulnerable populations of smokers be targeted with treatment .
BACKGROUND	The U.S. Public Health Service recommends that all patients be asked about their smoking at every visit and that smokers be given brief advice to quit and referred to treatment .
OBJECTIVE	Initiatives to facilitate these practices include the 5A 's ( ask , advise , assess , assist , arrange ) and Ask-Advise-Refer ( AAR ) .
OBJECTIVE	Unfortunately , primary care referrals are low , and most smokers referred fail to enroll .
OBJECTIVE	This study evaluated the efficacy of the Ask-Advise-Connect ( AAC ) approach to linking smokers with treatment in a large , safety net public healthcare system .
METHODS	The study design was a pair-matched group-randomized trial with two treatment arms .
METHODS	Ten safety net clinics in Houston TX .
METHODS	Clinics were randomized to AAC ( n = 5 ; intervention ) or AAR ( n = 5 ; control ) .
METHODS	Licensed vocational nurses ( LVNs ) were trained to assess and record the smoking status of all patients at all visits in the electronic health record .
METHODS	Smokers were given brief advice to quit .
METHODS	In AAC , the names and phone numbers of smokers who agreed to be connected were sent electronically to the Texas quitline daily , and patients were proactively called by the quitline within 48 hours .
METHODS	In AAR , smokers were offered a quitline referral card and encouraged to call on their own .
METHODS	Data were collected between June 2010 and March 2012 and analyzed in 2012 .
METHODS	The primary outcome was impact , defined here as the proportion of identified smokers that enrolled in treatment .
RESULTS	The impact ( proportion of identified smokers who enrolled in treatment ) of AAC ( 14.7 % ) was significantly greater than the impact of AAR ( 0.5 % ) , t ( 4 ) = 14.61 , p = 0.0001 , OR = 32.10 ( 95 % CI = 16.60 , 62.06 ) .
CONCLUSIONS	The AAC approach to aiding smoking cessation has tremendous potential to reduce tobacco-related health disparities .

###24287370
BACKGROUND	Nanosomal docetaxel lipid suspension formulation was developed to eliminate ethanol and polysorbate 80 from the currently used docetaxel ( Taxotere ) drug for treatment of cancer patients .
BACKGROUND	NDLS clinical safety and efficacy was evaluated and compared with Taxotere at 75 mg/m ( 2 ) in metastatic breast cancer patients .
METHODS	A total of 72 patients were randomized in a ratio of 2:1 ( NDLS : Taxotere ) .
METHODS	Patients treated with NDLS were not premedicated with corticosteroids as required with solvent-based Taxotere .
METHODS	Disease status and tumor response was assessed after every 2 cycles of treatment using Response Evaluation Criteria in Solid Tumors 1.1 guidelines through cycle6 .
RESULTS	Overall therapeutic response ( complete + partial ) rate in metastatic breast cancer patients treated with NDLS and Taxotere were 35.5 % and 26.3 % , respectively , indicating better response in patients treated with NDLS .
RESULTS	Patients in the NDLS group were not premedicated but the safety results of NDLS were found to be comparable with Taxotere .
CONCLUSIONS	NDLS formulation with no premedication provides an alternative treatment option for breast cancer patients .

###25445081
OBJECTIVE	Social anxiety disorder ( SAD ) impacts social , occupational and academic functioning .
OBJECTIVE	Although many interventions report change in social distress , improvement in social behavior remains under-addressed .
OBJECTIVE	This investigation examined the additive impact of social skills training ( SST ) for the treatment of SAD .
METHODS	Using a sample of 106 adults who endorsed SAD across numerous social settings , participants were randomized to exposure therapy ( imaginal and in vivo ) alone , a combination of SST and exposure therapy known as Social Effectiveness Therapy ( SET ) , or a wait list control .
METHODS	The assessment strategy included self-report measures , blinded clinical ratings and blinded assessment of social behavior .
RESULTS	Both interventions significantly reduced distress in comparison to the wait list control and at post-treatment , 67 % of patients treated with SET and 54 % of patients treated with exposure therapy alone no longer met diagnostic criteria for SAD , a difference that was not statistically significant .
RESULTS	When compared to exposure therapy alone , SET produced superior outcomes ( p < .05 ) on measures of social skill and general clinical status .
RESULTS	In addition to statistical significance , participants treated with SET or exposure reported clinically significant decreases on two measures of self-reported social anxiety and several measures of observed social behavior ( all ps < .05 ) .
CONCLUSIONS	Both interventions produced efficacious treatment outcome , although SET may provide additional benefit on measures of social distress and social behavior .

###25091871
OBJECTIVE	To determine the impact of losing health insurance coverage on perceived need for and access to mental health care in women screened for postpartum depression ( PPD ) in primary care settings .
METHODS	The study sample included 2343 women enrolled in a 12-month , multisite , randomized trial that compared clinical outcomes of a comprehensive PPD screening and management program with usual care ( March 1 , 2006 , through August 31 , 2010 ) .
METHODS	Screening for PPD occurred at the first postpartum visit ( 5-12 weeks ) using the Edinburgh Postnatal Depression Scale followed by the 9-item Patient Health Questionnaire .
METHODS	Insurance status during the prenatal period , at delivery , and during the first postpartum year and perceived need for and access to mental health care during the first postpartum year were assessed via questionnaires completed by individual patients and participating practices .
RESULTS	Rates of uninsured increased from 3.8 % during pregnancy and delivery ( n = 87 of 2317 ) to 10.8 % at the first postpartum visit ( n = 253 of 2343 ) and 13.7 % at any subsequent visit to the practice after 2 months post partum ( n = 226 of 1646 ) ( P < .001 , both comparisons vs baseline ) .
RESULTS	For patients with data on insurance type during follow-up , insurance loss occurred primarily in Medicaid beneficiaries .
RESULTS	Nine-item Patient Health Questionnaire scores and self-reported need for mental health care did not differ significantly between patients who remained insured and those who lost insurance during the first postpartum year .
RESULTS	However , of patients who reported the need for mental health care , 61.1 % of the uninsured ( n = 66 of 108 ) vs 27.1 % of the insured ( n = 49 of 181 ) reported an inability to obtain mental health care ( P < .001 ) .
CONCLUSIONS	Loss of insurance during the first postpartum year did not significantly affect depressive symptoms or perceived need for mental health care but did adversely affect self-reported ability to obtain mental health care .

###24415271
BACKGROUND	In most treated patients with hypertension , a two or more drug combination is required to achieve adequate blood pressure ( BP ) control .
BACKGROUND	In our study we assessed whether the combination of zofenopril + hydrochlorothiazide ( HCTZ ) was at least as effective as irbesartan + HCTZ in essential hypertensives with at least one additional cardiovascular risk factor , uncontrolled by a previous monotherapy .
METHODS	After a 2-week placebo washout , 361 treated hypertensive patients [ office sitting diastolic BP ( DBP ) , 90mmHg ] , aged 18-75years , were randomized double blind to 18-week treatment with zofenopril 30mg plus HCTZ 12.5 mg or irbesartan 150mg plus HCTZ 12.5 mg once daily , in an international , multicenter study .
METHODS	After the first 6 and 12weeks , zofenopril and irbesartan doses could be doubled in non-normalized subjects .
METHODS	The primary study end point was the office sitting DBP reduction after 18weeks of treatment .
METHODS	Secondary end points included office systolic BP ( SBP ) , ambulatory BP and high sensitivity C-reactive protein ( hs-CRP ) .
RESULTS	The between-treatment difference for office DBP averaged to +1.0 ( 95 % CI -0.4 , +0.8 ) mmHg ( P = 0.150 ) , the upper limit of the 95 % confidence interval being inferior to the protocol-defined non-inferiority limit ( 3mmHg ) .
RESULTS	In the subset of patients with valid ambulatory BP , no difference in 24-h average DBP [ n = 181 ; 6.7 ( 8.7 , 4.6 ) zofenopril + HCTZ vs. 6.3 ( 8.8 , 3.7 ) mmHg irbesartan + HCTZ , P = 0.810 ] and SBP reductions [ 11.7 ( 15.4 , 8.0 ) vs. 12.6 ( 17.2 , 8.0 ) mmHg , P = 0.758 ] were observed between the two treatment groups .
RESULTS	hs-CRP was reduced by zofenopril + HCTZ [ -0.52 ( -1.05 , 0.01 ) mg/L ] , while it was increased by irbesartan plus HCTZ [ 0.97 ( 0.29 , 1.65 ) mg/L , P = 0.001 between treatments ] .
CONCLUSIONS	In previously monotherapy-treated , uncontrolled patients with hypertension , zofenopril 30-60mg + HCTZ 12.5 mg is as effective as irbesartan 150-300mg plus HCTZ 12.5 mg , with the added value of a potential protective effect against vascular inflammation .

###24659236
BACKGROUND	Antithrombotic drugs , such as low-dose aspirin ( LDA ) and clopidogrel , can cause upper gastrointestinal complications .
OBJECTIVE	The goal of the present study was to investigate whether a mucosal-protective agent , rebamipide , could prevent gastric mucosal injuries induced by LDA with or without clopidogrel in healthy subjects .
METHODS	A randomized , double-blind , placebo-controlled trial was performed with 32 healthy male volunteers .
METHODS	Subjects were randomly assigned to a 14-day course of one of the following regimens : group A , placebo ( tid ) + LDA ; group B , rebamipide ( 100 mg tid ) + LDA ( 100 mg once-daily ) ; group C , placebo + LDA + clopidogrel ( 75 mg once-daily ) ; or group D , rebamipide + LDA + clopidogrel .
METHODS	The grade of gastric mucosal injuries was evaluated by esophagogastroduodenoscopy before and after dosing ( on day 0 and day 14 ) , and the grade of gastric mucosal injury was assessed according to the modified Lanza score .
METHODS	Subjective symptoms were assessed using the Gastrointestinal Symptom Rating Scale ( GSRS ) .
METHODS	A rapid urease test was performed on day 0 , and blood tests were performed on day 0 and day 14 .
RESULTS	Rebamipide significantly inhibited gastric mucosal injury induced by LDA alone or by LDA plus clopidogrel when compared with placebo in healthy subjects .
RESULTS	GSRS score and hemoglobin level were not significantly different among the four groups .
CONCLUSIONS	Rebamipide is useful for the primary prevention of gastric mucosal injury induced by LDA alone or by LDA plus clopidogrel in healthy subjects .

###25500485
OBJECTIVE	A new twice daily sustained-release ( SR ) paracetamol formulation was developed to improve convenience and enhance patient compliance for treatment of pain from chronic diseases .
OBJECTIVE	This research aimed to evaluate bioavailability and compare pharmacokinetic ( PK ) properties of the new SR paracetamol formulation ( 2x1 ,000 mg ) with those of immediate-release ( IR ) paracetamol ( 2x500 mg ) and existing extended-release ( ER ) paracetamol ( 2x665 mg ) .
METHODS	Two randomized , single-dose , 4-way crossover studies were conducted .
METHODS	A total of 28 healthy male and female volunteers participated in each study .
METHODS	The relative bioavailability , partial extent of absorption , overall elimination , food effect , and safety were evaluated .
RESULTS	The estimates of relative bioavailability of new SR with IR formulation based on dose-adjusted AUC0-inf were 91 % ( 0.86-0 .96 ) for the fasted state and 99 % ( 0.95-1 .02 ) for the fed state , while these estimates comparing new SR with ER formulation were 99 % ( 0.96-1 .03 ) in the fasted state and 98 % ( 0.95-1 .02 ) in the fed state .
RESULTS	The accumulated mean time period at or above the minimal therapeutic plasma paracetamol concentration for the new SR was from 90 % to 112 % longer than that of the IR formulation , in fasted and fed state , respectively .
RESULTS	Food significantly increased Cmax of SR formulation , with ratios fast vs. fed 0.79 ( p < 0.0001 ) and 0.77 ( p < 0.0001 ) in study I and II , respectively .
CONCLUSIONS	The new SR formulation was well absorbed , with more than 90 % relative bioavailability as compared to the currently marketed IR and ER products and better sustained-release PK characteristics , which make it suitable for twice-daily paracetamol treatment .

###25596108
OBJECTIVE	To use a high-quality multicenter trial dataset to determine dose-volume effects for gastrointestinal ( GI ) toxicity following radiation therapy for prostate carcinoma .
OBJECTIVE	Influential dose-volume histogram regions were to be determined as functions of dose , anatomical location , toxicity , and clinical endpoint .
METHODS	Planning datasets for 754 participants in the TROG 03.04 RADAR trial were available , with Late Effects of Normal Tissues ( LENT ) Subjective , Objective , Management , and Analytic ( SOMA ) toxicity assessment to a median of 72 months .
METHODS	A rank sum method was used to define dose-volume cut-points as near-continuous functions of dose to 3 GI anatomical regions , together with a comprehensive assessment of significance .
METHODS	Univariate and multivariate ordinal regression was used to assess the importance of cut-points at each dose .
RESULTS	Dose ranges providing significant cut-points tended to be consistent with those showing significant univariate regression odds-ratios ( representing the probability of a unitary increase in toxicity grade per percent relative volume ) .
RESULTS	Ranges of significant cut-points for rectal bleeding validated previously published results .
RESULTS	Separation of the lower GI anatomy into complete anorectum , rectum , and anal canal showed the impact of mid-low doses to the anal canal on urgency and tenesmus , completeness of evacuation and stool frequency , and mid-high doses to the anorectum on bleeding and stool frequency .
RESULTS	Derived multivariate models emphasized the importance of the high-dose region of the anorectum and rectum for rectal bleeding and mid - to low-dose regions for diarrhea and urgency and tenesmus , and low-to-mid doses to the anal canal for stool frequency , diarrhea , evacuation , and bleeding .
CONCLUSIONS	Results confirm anatomical dependence of specific GI toxicities .
CONCLUSIONS	They provide an atlas summarizing dose-histogram effects and derived constraints as functions of anatomical region , dose , toxicity , and endpoint for informing future radiation therapy planning .

###25791716
OBJECTIVE	In the Interventional Management of Stroke ( IMS ) III trial , we sought to demonstrate evidence of a differential treatment effect of endovascular treatment of acute ischemic stroke compared with intravenous tissue-type plasminogen activator , according to baseline collateral status measured using computed tomographic angiography .
METHODS	Of 656 patients enrolled in Interventional Management of Stroke III trial , 306 had baseline computed tomographic angiography .
METHODS	Of these , 185 patients had M1 middle cerebral artery intracranial internal carotid artery occlusion , where baseline collateral status could be measured .
METHODS	Collateral status was assessed by consensus using 3 different ordinal scales and categorized as good , intermediate , and poor .
METHODS	Multivariable modeling was used to assess the effect of collateral status and treatment type on clinical outcome by modified Rankin Scale ( mRS 0-2 , mRS 0-1 , and the ordinal mRS ) .
RESULTS	Of 185 patients , 126 randomized to endovascular therapy ( 87.6 % recanalized , 41.3 % 90-day mRS 0-2 ) and 59 to intravenous tissue-type plasminogen activator only ( 60.5 % recanalized , 30.5 % 90-day mRS 0-2 ) .
RESULTS	In multivariable modeling , collateral status was a significant predictor of all clinical outcomes ( P < 0.05 ) .
RESULTS	Maximal benefit with endovascular treatment across all clinical outcomes was seen in patients with intermediate collaterals , some benefit in patients with good collaterals , and none in patients with poor collaterals , although small sample size limited the power of the analysis to show a statistically significant interaction between collateral status and treatment type ( P > 0.05 ) .
CONCLUSIONS	Using data from a large randomized controlled trial ( IMS III ) , we show that baseline computed tomographic angiography collaterals are a robust determinant of final clinical outcome and could be used to select patients for endovascular therapy .
BACKGROUND	URL : http://www.clinicaltrials.gov/ct2/show/ .
BACKGROUND	Unique identifier : 0020NCT00359424 .

###26039792
BACKGROUND	The combination of an ultrathin bronchoscope , navigational technology , and endobronchial ultrasound ( EBUS ) seems to combine the best of mutual abilities for evaluating peripheral pulmonary lesions , but ultrathin bronchoscopes that allow the use of EBUS have not been developed so far .
OBJECTIVE	To compare the diagnostic yield of transbronchial biopsy under EBUS , fluoroscopy , and virtual bronchoscopic navigation guidance using a novel ultrathin bronchoscope with that using a thin bronchoscope with a guide sheath for peripheral pulmonary lesions .
METHODS	In four centers , patients with suspected peripheral pulmonary lesions less than or equal to 30 mm in the longest diameter were included and randomized to undergo transbronchial biopsy with EBUS , fluoroscopy , and virtual bronchoscopic navigation guidance using a 3.0-mm ultrathin bronchoscope ( UTB group ) or a 4.0-mm thin bronchoscope with a guide sheath ( TB-GS group ) .
RESULTS	A total of 310 patients were enrolled and randomized , among whom 305 patients ( 150 , UTB group ; 155 , TB-GS group ) were analyzed .
RESULTS	The ultrathin bronchoscope could reach more distal bronchi than the thin bronchoscope ( median fifth - vs. fourth-generation bronchi ; P < 0.001 ) .
RESULTS	Diagnostic histologic specimens were obtained in 74 % ( 42 % for benign and 81 % for malignant lesions ) of the UTB group and 59 % ( 36 % for benign and 70 % for malignant lesions ) of the TB-GS group ( P = 0.044 , Mantel-Haenszel test ) .
RESULTS	Complications including pneumothorax , bleeding , chest pain , and pneumonia occurred in 3 % and 5 % in the respective groups .
CONCLUSIONS	The diagnostic yield of the UTB method is higher than that of the TB-GS method .
CONCLUSIONS	Clinical trial registered with www.umin.ac.jp/ctr/ ( UMIN 000003177 ) .

###24584708
OBJECTIVE	To compare the function of retinal ganglion cells ( RGCs ) using the photopic negative response ( PhNR ) in patients who had undergone indocyaine green ( ICG ) - assisted , brilliant blue G ( BBG ) - assisted , or triamcinolone acetonide ( TA ) - assisted internal limiting membrane ( ILM ) peeling during macular hole ( MH ) surgery .
METHODS	Forty-eight eyes of 48 patients with a macular hole were randomly divided into those undergoing ICG-assisted , BBG-assisted , or TA-assisted vitrectomy ( n = 16 for each group ) .
METHODS	Full-field cone ERGs were recorded before and 1 , 3 , 6 , 9 , and 12months postoperatively .
METHODS	The amplitudes and implicit times of the a-waves and b-waves and the amplitudes of the oscillatory potentials ( OPs ) and PhNRs were measured .
METHODS	The mean deviations ( MDs ) of standard automated perimetry and the best-corrected visual acuity ( BCVA ) were measured .
METHODS	The circumferential retinal nerve fiber layer ( RNFL ) thickness was evaluated by SD-OCT .
RESULTS	All macular holes were closed with a significant improvement of the BCVA and MD without differences among the groups .
RESULTS	There was no significant difference between the preoperative and postoperative RNFL thickness .
RESULTS	The implicit times of the a-waves and b-waves were significantly prolonged , and the OPs amplitude was significantly decreased postoperatively in all groups .
RESULTS	These ERG changes were not significantly different among the groups .
RESULTS	The postoperative PhNR amplitudes were significantly lower in the ICG group than in the BBG or TA group .
CONCLUSIONS	The results indicate that the PhNR may detect subclinical impairments of RGCs caused by the possible toxic effect of ICG .
CONCLUSIONS	This finding adds to the data that BBG and TA may be safer than ICG for use during MH surgery .

###25826322
OBJECTIVE	Standard therapies for severe dry eye are limited and fail to resolve the problem .
OBJECTIVE	The purpose of this study was to evaluate the safety and efficacy of Thymosin 4 eye drops ( RGN-259 ) as a novel therapy for severe dry eye disease ( including that associated with graft vs. host disease ) .
METHODS	A small , multicenter , randomized , double-masked , placebo-controlled 56-day phase 2 clinical trial including a 28-day follow-up at 2 US sites .
METHODS	Nine patients with severe dry eye were treated with either RGN-259 ( 0.1 % ) or vehicle control 6 times daily over a period of 28 days .
METHODS	Dry eye sign and symptom assessments , such as ocular discomfort ( using the OSDI questionnaire ) and corneal fluorescein staining ( using the NEI workshop grading system ) , were evaluated at various time points .
RESULTS	Statistically significant differences in both symptom and sign assessments , were seen at various time points throughout the study .
RESULTS	Of particular note at day 56 , the RGN-259-treated group ( 12 eyes ) had 35.1 % reduction of ocular discomfort compared with vehicle control ( 6 eyes ) ( P = 0.0141 ) , and 59.1 % reduction of total corneal fluorescein staining compared with vehicle control ( P = 0.0108 ) .
RESULTS	Other improvements seen in the RGN-259-treated patients included tear film breakup time and increased tear volume production .
CONCLUSIONS	In this small trial , RGN-259 eye drops were safe and well tolerated and met key efficacy objectives with statistically significant symptom and sign improvements , compared with vehicle control , at various time intervals , including 28-days posttreatment .
CONCLUSIONS	CLINICAL TRIAL REGISTRATION -- URL : http://www.clinicaltrials.gov .
CONCLUSIONS	Unique identifier : NCT01393132 .

###25618415
BACKGROUND	Single-agent gemcitabine ( GEM ) has been considered for many years as the standard first-line treatment for advanced pancreatic cancer .
BACKGROUND	However , recently , several studies reported encouraging activity and good tolerability for some combination regimens .
BACKGROUND	Considering the apparently non-overlapping toxicity and the proved individual efficacy of GEM , oxaliplatin ( L-OHP ) , and capecitabine ( CAP ) , this randomized phase II study compared the activity and safety of the combination GEM , L-OHP , and CAP ( GEMOXEL ) versus GEM alone , in patients with metastatic pancreatic cancer .
METHODS	The treatment in GEMOXEL arm consisted of GEM 1,000 mg/m ( 2 ) as a 30-min intravenous infusion on days 1 , 8 , 15 , 22 , L-OHP 100 mg/m ( 2 ) i.v. on day 2 , and CAP 1,500 mg/m ( 2 ) / day in two divided doses on days 1-14 , every 21 days ( one cycle ) .
METHODS	In both treatment groups , GEM was administered weekly for seven consecutive weeks followed by 1-week rest for the first 8 weeks , and thereafter , GEM was continued on days 1 , 8 , 15 , every 28 days .
METHODS	Chemotherapy was administered until disease progression or unacceptable toxicity .
RESULTS	Sixty-seven patients were enrolled in the study .
RESULTS	Thirty-four were randomly assigned to GEMOXEL and 33 to GEM .
RESULTS	At 4 months , disease control rate was 79.4 % with GEMOXEL versus 45.4 % with GEM ( p = 0.004 ) .
RESULTS	The median progression-free survival was 6.8 months ( 95 % CI 5.3-7 .3 months ) in GEMOXEL arm and 3.7 months ( 95 % CI 2.9-4 .7 months ) in GEM arm ( p < 0.001 ) .
RESULTS	The median OS was 11.9 months ( 95 % CI 10.6-12 .9 months ) in GEMOXEL arm and 7.1 months ( 95 % CI 5.5-9 .1 months ) in GEM arm ( p < 0.001 ) .
RESULTS	Hematologic and non-hematologic toxicity was more severe with combination chemotherapy , yet still tolerable .
RESULTS	No grade 4 adverse events were observed with either regimen .
CONCLUSIONS	GEMOXEL regimen seemed to be safe and more efficient than the standard therapy with GEM alone in the treatment of metastatic pancreatic cancer .

###24641328
BACKGROUND	Long-distance air travel is associated with an increased risk of venous thrombosis .
BACKGROUND	The most obvious factor that can explain air travel-related thrombosis is prolonged seated immobilization .
BACKGROUND	In addition , hypobaric hypoxia has been shown to affect coagulation , and the lowered atmospheric pressures present in the cabin during the flight may therefore play an etiologic role .
BACKGROUND	Because immobilization and hypoxic conditions are usually present simultaneously in airplanes or hypobaric chambers , their separate effects on the coagulation system or on thrombosis risk have not been studied extensively .
OBJECTIVE	To investigate the separate effects of long-term immobilization and profound prolonged hypoxia on blood coagulation .
METHODS	We performed two studies in collaboration with European Space Agency/European Space Research and Technology Centre .
METHODS	In the first study , 24 healthy , non-smoking , adult women underwent 60 days of -6 head-down bed rest .
METHODS	In the second study , we took blood samples from 25 healthy men who participated during their stay in the Concordia station in Antarctica , where , due to the atmospheric conditions , continuous severe hypobaric hypoxia is present .
METHODS	In both studies , we measured markers of blood coagulation at baseline and at several time points during the exposures .
CONCLUSIONS	We observed no increase in coagulation markers during immobilization or in the hypobaric environment , compared with baseline measurements .
CONCLUSIONS	Our results indicate that neither immobilization nor hypoxia per se affects blood coagulation .
CONCLUSIONS	These results implicate that a combination of risk factors is necessary to induce the coagulation system during air travel .

###24354616
BACKGROUND	A proposal has recently been made regarding the potential adjuvant use of platelet-rich plasma ( PRP ) with fractional carbon dioxide laser ( FCL ) for the correction of acne scars .
OBJECTIVE	To compare the efficacy and safety of two administration modes of autologous PRP ( intradermal injection ( ID ) and topical application ) after FCL with that of FCL alone in the treatment of atrophic acne scars .
METHODS	Thirty patients were randomly divided into two groups .
METHODS	Both underwent split-face therapy .
METHODS	Group 1 was administered FCL followed by ID PRP on one side and FCL followed by ID saline on the other .
METHODS	In group 2 , one cheek was treated with FCL followed by ID PRP , and the other received FCL followed by topical PRP .
METHODS	Each patient received 3monthly sessions .
METHODS	The final assessment took place at 6months .
RESULTS	Combined PRP - and FCL-treated areas had a significantly better response ( p = .03 ) , fewer side effects , and shorter downtime ( p = .02 ) than FCL-treated areas , but there were no significant differences in ID - and topical PRP-treated areas in degree of response and downtime ( p = .10 ) ; topically treated areas had significantly lower pain scores .
CONCLUSIONS	The current study introduces the combination of topical PRP and FCL as an effective , safe modality in the treatment of atrophic acne scars with shorter downtime than FCL alone and better tolerability than FCL combined with ID PRP .

###25856450
BACKGROUND	The need for evidence-based practice in nursing is well established ; however , the efficacy of providing online research resources to nurses delivering care at the bedside has yet to undergo empirical testing .
BACKGROUND	This study evaluated the impact of minimal educational support by a nurse researcher on nurses ' usage of a hospital-based online nursing reference center .
METHODS	This randomized , comparison group design feasibility study was conducted at a suburban medical center .
METHODS	Real-time RN usage of an online nursing reference center was collected over 10 months ( August to May ) , with the comparative intervention occurring for seven of the 10 months ( September to March ) .
RESULTS	Independent samples t tests and analysis of variance demonstrated that nurses receiving weekly or biweekly visits from an educator had significantly higher usage of the reference center .
CONCLUSIONS	Nurses who received minimal educational support through weekly and biweekly brief , verbally supportive visits from a nurse researcher were significantly higher users of the online nurse reference center than those receiving in-services only .

###24226492
BACKGROUND	The aim of this study was compare the Aldrete score at 5 minutes of two groups of patients undergoing carotid endarterectomy with intravenous anesthesia , receiving either anesthetic superficial cervical plexus block or intravenous morphine as transition analgesia .
METHODS	After Ethics Committee approval , this randomized , controlled , double-blind , single-center study was performed on patients undergoing carotid endarterectomy , who received total intravenous anesthesia with propofol and remifentanil infusion .
METHODS	After intubation , each patient was randomly assigned to Block ( superficial cervical block with levobupivacaine before the surgical incision ) , or Morphine group ( standardized dose of morphine 30 minutes before the end of surgery ) .
METHODS	In the recovery room , an investigator unaware of the patient randomization recorded time to extubation , Aldrete score , pain , nausea/vomiting , and shiver at T0 ( time of extubation ) , and at 5 ( T5 ) , 10 ( T10 ) , and 30 minutes ( T30 ) after extubation .
RESULTS	Sixty-four patients were studied .
RESULTS	Time to extubation was 11 6 min for Block and 20 10 min for Morphine group ( P > 0.001 ) .
RESULTS	Median Aldrete score at T0 was 9 in the Block and 6.5 in the Morphine group ( P < 0.001 ) , at T5 it was 8.5 and 7.0 ( P < 0.001 ) , respectively .
RESULTS	At T5 , 29 ( 90.6 % ) Block and 8 ( 25 % ) Morphine patients had an Aldrete score 8 ( P < 0.001 ) .
RESULTS	Systolic blood pressure was higher in the Block than in Morphine patients at T0 and T5 .
CONCLUSIONS	This study demonstrates shorter time to extubation and better emergence from anesthesia when total intravenous anesthesia is associated with superficial cervical block than with morphine as transition analgesia .

###25148570
BACKGROUND	The data of MARCH ( Metformin and AcaRbose in Chinese as the initial Hypoglycaemic treatment ) trial demonstrated that acarbose and metformin have similar efficacy as initial therapy for hemoglobin A1c ( HbA1c ) reduction in Chinese patients with newly diagnosed type 2 diabetes .
BACKGROUND	We investigated whether the therapeutic efficacy was diversified under different body mass index ( BMI ) status .
METHODS	All 784 subjects were divided into normal-weight group ( BMI < 24 kg/m2 ) , overweight group ( BMI 24-28 kg/m2 ) and obese group ( BMI28 kg/m2 ) .
METHODS	Patients were assigned to 48 weeks of therapy with acarbose or metformin , respectively .
METHODS	The clinical trial registry number was ChiCTR-TRC-08000231 .
RESULTS	The reduction of HbA1c levels and the proportion of patients with HbA1c of 6.5 % or less were similar in the three groups after acarbose and metformin treatment .
RESULTS	In overweight group , fasting blood glucose ( FBG ) after metformin treatment showed greater decline compared to acarbose group at 48 weeks [ -1.73 ( -1.99 to -1.46 ) vs. -1.37 ( -1.61 to -1.12 ) , P < 0.05 ) , however the decrease of 2 h post-challenge blood glucose ( PBG ) after acarbose treatment at 48 weeks was bigger compared to metformin group [ -3.34 ( -3.83 to-2 .84 ) vs. -2.35 ( -2.85 to -1.85 ) , P < 0.01 ] .
RESULTS	Both acarbose and metformin treatment resulted in a significant decrease in waist circumference , hip circumference , weight and BMI in the three groups ( all P < 0.05 ) .
CONCLUSIONS	Acarbose and metformin decreased HbA1c levels similarly regardless of BMI status of Chinese type 2 diabetic patients .
CONCLUSIONS	Acarbose and metformin resulted in a significant and modest improvement of anthropometric parametres in different BMI status .
CONCLUSIONS	Thus , acarbose treatment may contribute a similar effect on plasma glucose control compared to metformin , even in obesity patients .
BACKGROUND	ChiCTR.org ChiCTR-TRC-08000231 .

###25267163
OBJECTIVE	According to the latest ART report for Europe , about 13 % of pregnancies after frozen embryo transfer are multiple .
OBJECTIVE	Our objective was to analyse the impact on the multiple pregnancy rate of two eSFET ( elective single frozen embryo transfers ) versus a DFET ( double frozen embryo transfer ) in women aged under 38 years , who had not achieved pregnancy in their fresh transfer and who had at least two vitrified embryos of A/B quality .
METHODS	This study was conducted from January 2010 to June 2013 at a public hospital .
METHODS	The couples were divided into three groups .
METHODS	Group DFET : the first cryotransfer of two embryos ( 105 women ) ; cSFET group : the only cryotransfer of a single vitrified embryo ( 60 women ) ; eSFET group , individually vitrified embryos : 20 patients included in a clinical trial of single-embryo fresh and frozen transfer and 21 patients who chose to receive eSFET .
RESULTS	The clinical pregnancy rate was 38.1 % in the DET group and the cumulative clinical pregnancy rate was 43.3 % in the eSFET group .
RESULTS	There were no significant differences between the DFET and eSFET groups ( 30.0 vs 34.1 % ) in cumulative live birth delivery rate .
RESULTS	The rate of multiple pregnancies varied significantly between the DFET and eSFET groups ( 32.5 vs 0 % , p < 0.05 ) .
CONCLUSIONS	For good-prognosis women aged under 38 years , taking embryo quality as a criterion for inclusion , an eSFET policy can be applied , achieving acceptable cumulative clinical pregnancy and live birth rates and reducing multiple pregnancy rates .

###24767719
BACKGROUND	Relapses of childhood steroid-sensitive nephrotic syndrome ( SSNS ) are treated with a 4 - to 8-week course of high-dose oral prednisolone , which may be associated with significant adverse effects .
BACKGROUND	There is a clear association between upper respiratory tract infection ( URTI ) and relapse development .
BACKGROUND	Previous studies in developing nations have suggested that introducing a 5 - to 7-day course of daily prednisolone during an URTI may prevent a relapse developing and the need for a treatment course of high-dose prednisolone .
BACKGROUND	The aim of PREDNOS 2 is to evaluate the effectiveness of a 6-day course of daily prednisolone therapy during an URTI in reducing the development of a subsequent relapse in a developed nation .
METHODS	The subjects will be 300 children with relapsing SSNS ( 2 relapses in preceding year ) , who will be randomised to receive either a 6-day course of daily prednisolone or no change to their current therapy ( with the use of placebo to double blind ) each time they develop an URTI over 12months .
METHODS	A strict definition for URTI will be used .
METHODS	Subjects will be reviewed at 3 , 6 , 9 and 12months to capture data regarding relapse history , ongoing therapy and adverse effect profile , including behavioural problems and quality of life .
METHODS	A formal health economic analysis will also be performed .
METHODS	The primary end point of the study will be the incidence of URTI-related relapse ( 3days of Albustix + + + ) following the first infection during the 12-month follow-up period .
METHODS	DNA and RNA samples will be collected to identify a potential genetic cause for the disease .
METHODS	Subjects will be recruited from over 100 UK centres with the assistance of the Medicines for Children Research Network.PREDNOS 2 is funded by the National Institute for Health Research Health Technology Assessment Programme ( 11/129/261 ) .
CONCLUSIONS	We propose that PREDNOS 2 will be a pivotal study that will inform the future standard of care for children with SSNS .
CONCLUSIONS	If it is possible to reduce the disease relapse rate effectively and safely , this will reduce the morbidity and cost associated with drug treatment , notwithstanding hospital admission and parental absence from employment .
BACKGROUND	Current Controlled Trials ( ISRCTN10900733 ) .

###25331236
OBJECTIVE	To determine the difference in outcome between a 1 - day and 5 - day antibiotic regimen in the prevention of infective complications following transrectal prostate biopsy .
METHODS	This prospective comparative study was done in the urology unit of University of Benin Teaching Hospital over a period of 14 months .
METHODS	Eighty seven patients were randomly assigned to 2 groups prior to the procedure .
METHODS	The patients in group I ( N = 42 ) received oral ciprofloxacin ( 500mg , 12 hourly ) and oral metronidazole ( 400mg , 8 hourly ) for 1 day while those in group II ( N = 45 ) received same antibiotic combination for 5 days .
METHODS	Urine samples for culture were taken an hour before the procedure and then 5 days after in all patients .
METHODS	Temperature monitoring with an easy-to-use thermometer was done thrice daily by the patients .
METHODS	Post biopsy fever and positive urine cultures were indicative of infection .
RESULTS	The mean age of the patients was 68.5 8.1 years .
RESULTS	Infective complications occurred in 8 ( 19 % ) in group I and 7 ( 15.6 % ) in group II .
RESULTS	Fever was noted in 5 patients in group I and 4 patients in group II ( p = 0.73 ) while positive urine culture was noted in 4 patients in each group ( p = 1.00 ) .
RESULTS	Complications were minor and transient except in a case of septicaemia in group II that required hospitalisation .
RESULTS	Escherischia coli was the most common organism isolated from positive urine cultures .
CONCLUSIONS	A 1-day antibiotic regimen of oral ciprofloxacin and metronidazole is as effective as a 5-day regimenin the prevention of infective complications following transrectalprostate biopsy .

###26017188
OBJECTIVE	The use of perioperative pharmacologic - blockade in patients at low risk of myocardial ischemic events undergoing noncardiac surgery ( NCS ) is controversial because of the risk of stroke and hypotension .
OBJECTIVE	Published studies have not found a consistent benefit in this cohort .
OBJECTIVE	To determine the effect of perioperative - blockade on patients undergoing NCS , particularly those with no risk factors .
METHODS	This is a retrospective observational analysis of patients undergoing surgery in Veterans Affairs hospitals from October 1 , 2008 , through September 31 , 2013 .
METHODS	- Blocker use was determined if a dose was ordered at any time between 8 hours before surgery and 24 hours postoperatively .
METHODS	Data from the Veterans Affairs electronic database included demographics , diagnosis and procedural codes , medications , perioperative laboratory values , and date of death .
METHODS	A 4-point cardiac risk score was calculated by assigning 1 point each for renal failure , coronary artery disease , diabetes mellitus , and surgery in a major body cavity .
METHODS	Previously validated linear regression models for all hospitalized acute care medical or surgical patients were used to calculate predicted mortality and then to calculate odds ratios ( ORs ) .
METHODS	The end point was 30-day surgical mortality .
RESULTS	There were 326,489 patients in this cohort : 314,114 underwent NCS and 12,375 underwent cardiac surgery .
RESULTS	- Blockade lowered the OR for mortality significantly in patients with 3 to 4 cardiac risk factors undergoing NCS ( OR , 0.63 ; 95 % CI , 0.43-0 .93 ) .
RESULTS	It had no effect on patients with 1 to 2 risk factors .
RESULTS	However , - blockade resulted in a significantly higher chance of death in patients ( OR , 1.19 ; 95 % CI , 1.06-1 .35 ) with no risk factors undergoing NCS .
CONCLUSIONS	In this large series , - blockade appears to be beneficial perioperatively in patients with high cardiac risk undergoing NCS .
CONCLUSIONS	However , the use of - blockers in patients with no cardiac risk factors undergoing NCS increased risk of death in this patient cohort .

###24894577
BACKGROUND	The role of positive end-expiratory pressure in mechanical ventilation during general anaesthesia for surgery remains uncertain .
BACKGROUND	Levels of pressure higher than 0 cm H2O might protect against postoperative pulmonary complications but could also cause intraoperative circulatory depression and lung injury from overdistension .
BACKGROUND	We tested the hypothesis that a high level of positive end-expiratory pressure with recruitment manoeuvres protects against postoperative pulmonary complications in patients at risk of complications who are receiving mechanical ventilation with low tidal volumes during general anaesthesia for open abdominal surgery .
METHODS	In this randomised controlled trial at 30 centres in Europe and North and South America , we recruited 900 patients at risk for postoperative pulmonary complications who were planned for open abdominal surgery under general anaesthesia and ventilation at tidal volumes of 8 mL/kg .
METHODS	We randomly allocated patients to either a high level of positive end-expiratory pressure ( 12 cm H2O ) with recruitment manoeuvres ( higher PEEP group ) or a low level of pressure ( 2 cm H2O ) without recruitment manoeuvres ( lower PEEP group ) .
METHODS	We used a centralised computer-generated randomisation system .
METHODS	Patients and outcome assessors were masked to the intervention .
METHODS	Primary endpoint was a composite of postoperative pulmonary complications by postoperative day 5 .
METHODS	Analysis was by intention-to-treat .
METHODS	The study is registered at Controlled-Trials .
METHODS	com , number ISRCTN70332574 .
RESULTS	From February , 2011 , to January , 2013 , 447 patients were randomly allocated to the higher PEEP group and 453 to the lower PEEP group .
RESULTS	Six patients were excluded from the analysis , four because they withdrew consent and two for violation of inclusion criteria .
RESULTS	Median levels of positive end-expiratory pressure were 12 cm H2O ( IQR 12-12 ) in the higher PEEP group and 2 cm H2O ( 0-2 ) in the lower PEEP group .
RESULTS	Postoperative pulmonary complications were reported in 174 ( 40 % ) of 445 patients in the higher PEEP group versus 172 ( 39 % ) of 449 patients in the lower PEEP group ( relative risk 101 ; 95 % CI 086-120 ; p = 086 ) .
RESULTS	Compared with patients in the lower PEEP group , those in the higher PEEP group developed intraoperative hypotension and needed more vasoactive drugs .
CONCLUSIONS	A strategy with a high level of positive end-expiratory pressure and recruitment manoeuvres during open abdominal surgery does not protect against postoperative pulmonary complications .
CONCLUSIONS	An intraoperative protective ventilation strategy should include a low tidal volume and low positive end-expiratory pressure , without recruitment manoeuvres .
BACKGROUND	Academic Medical Center ( Amsterdam , Netherlands ) , European Society of Anaesthesiology .

###25855120
BACKGROUND	An objective measure of added sugar ( AS ) and sugar-sweetened beverage ( SSB ) intake is needed .
BACKGROUND	The ( 13 ) C value of finger-stick blood is a novel validated biomarker of AS/SSB intake ; however , nonsweetener corn products and animal protein also carry a ( 13 ) C value similar to AS sources , which may affect blood ( 13 ) C values .
BACKGROUND	The ( 15 ) N value of blood has been proposed as a `` correction factor '' for animal protein intake .
OBJECTIVE	The objectives were to 1 ) identify foods associated with ( 13 ) C and ( 15 ) N blood values , 2 ) determine the contribution of nonsweetener corn to the diet relative to AS intake , and 3 ) determine if the dual-isotope model ( ( 13 ) C and ( 15 ) N ) is a better predictor of AS/SSB intake than ( 13 ) C alone .
METHODS	A cross-sectional sample of southwest Virginian adults ( n = 257 ; aged 42 15 y ; 74 % overweight/obese ) underwent dietary intake assessments and provided finger-stick blood samples , which were analyzed for ( 13 ) C and ( 15 ) N values by using natural abundance stable isotope mass spectrometry .
METHODS	Statistical analyses included ANOVAs , paired-samples t tests , and multiple linear regressions .
RESULTS	The mean SD daily AS intake was 88 59 g and nonsweetener corn intake was 13 13 g.
RESULTS	The mean ( 13 ) C value was -19.1 0.9 , which was significantly correlated with AS and SSB intakes ( r = 0.32 and 0.39 , respectively ; P 0.01 ) .
RESULTS	The ( 13 ) C value and nonsweetener corn intake and the ( 15 ) N value and animal protein intake were not correlated .
RESULTS	AS intake was significantly greater than nonsweetener corn intake ( mean difference = 76.2 57.2 g ; P 0.001 ) .
RESULTS	The ( 13 ) C value was predictive of AS/SSB intake ( range : 0.28-0 .35 ; P 0.01 ) ; however , ( 15 ) N was not predictive and minimal increases in R ( 2 ) values were observed when the ( 15 ) N value was added to the model .
CONCLUSIONS	The data do not provide evidence that the dual-isotope method is superior for predicting AS/SSB intakes within a southwest Virginian population .
CONCLUSIONS	Our results support the potential of the ( 13 ) C value of finger-stick blood to serve as an objective measure of AS/SSB intake .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT02193009 .

###25071075
OBJECTIVE	To comprehensively compare the effects of a very low-carbohydrate , high-unsaturated/low-saturated fat diet ( LC ) with those of a high-unrefined carbohydrate , low-fat diet ( HC ) on glycemic control and cardiovascular disease ( CVD ) risk factors in type 2 diabetes ( T2DM ) .
METHODS	Obese adults ( n = 115 , BMI 34.4 4.2 kg/m ( 2 ) , age 58 7 years ) with T2DM were randomized to a hypocaloric LC diet ( 14 % carbohydrate [ < 50 g/day ] , 28 % protein , and 58 % fat [ < 10 % saturated fat ] ) or an energy-matched HC diet ( 53 % carbohydrate , 17 % protein , and 30 % fat [ < 10 % saturated fat ] ) combined with structured exercise for 24 weeks .
METHODS	The outcomes measured were as follows : glycosylated hemoglobin ( HbA1c ) , glycemic variability ( GV ; assessed by 48-h continuous glucose monitoring ) , antiglycemic medication changes ( antiglycemic medication effects score [ MES ] ) , and blood lipids and pressure .
RESULTS	A total of 93 participants completed 24 weeks .
RESULTS	Both groups achieved similar completion rates ( LC 79 % , HC 82 % ) and weight loss ( LC -12.0 6.3 kg , HC -11.5 5.5 kg ) ; P 0.50 .
RESULTS	Blood pressure ( -9.8 / -7.3 11.6 / 6.8 mmHg ) , fasting blood glucose ( -1.4 2.3 mmol/L ) , and LDL cholesterol ( -0.3 0.6 mmol/L ) decreased , with no diet effect ( P 0.10 ) .
RESULTS	LC achieved greater reductions in triglycerides ( -0.5 0.5 vs. -0.1 0.5 mmol/L ) , MES ( -0.5 0.5 vs. -0.2 0.5 ) , and GV indices ; P 0.03 .
RESULTS	LC induced greater HbA1c reductions ( -2.6 1.0 % [ -28.4 10.9 mmol/mol ] vs. -1.9 1.2 % [ -20.8 13.1 mmol/mol ] ; P = 0.002 ) and HDL cholesterol ( HDL-C ) increases ( 0.2 0.3 vs. 0.05 0.2 mmol/L ; P = 0.007 ) in participants with the respective baseline values HbA1c > 7.8 % ( 62 mmol/mol ) and HDL-C < 1.29 mmol/L .
CONCLUSIONS	Both diets achieved substantial improvements for several clinical glycemic control and CVD risk markers .
CONCLUSIONS	These improvements and reductions in GV and antiglycemic medication requirements were greatest with the LC compared with HC .
CONCLUSIONS	This suggests an LC diet with low saturated fat may be an effective dietary approach for T2DM management if effects are sustained beyond 24 weeks .

###25143985
OBJECTIVE	To evaluate the safety of electrocautery for coagulation during Caesarean sections .
METHODS	A randomized , controlled , clinical pilot study was performed at a university maternity hospital .
METHODS	After admission for delivery and decision to perform a C-section , volunteers were randomized to either the intervention group ( use of electrocautery for coagulation ) or nonintervention group .
METHODS	The women were examined at the time of postpartum discharge ( day 3 ) , at days 7 to 10 , and again at days 30 to 40 for signs of infection , hematoma , seroma , or dehiscence .
METHODS	Data were analyzed using an intention-to-treat analysis , and risk ratios were calculated .
RESULTS	No significant differences were found between the two groups .
RESULTS	Only 2.8 % of patients in the intervention group developed surgical wound complications during hospitalization .
RESULTS	However , 7 to 10 days following discharge , these rates reached 23.0 % and 15.4 % in the intervention and nonintervention groups , respectively ( RR = 1.50 , 95 % CI = 0.84-2 .60 ) .
CONCLUSIONS	Further studies should confirm whether the use of electrocautery for coagulation does not increase the risk of surgical wound complications in patients undergoing Caesarean sections .

###24628972
BACKGROUND	The ToyBox-study developed an evidence - and theory-based intervention to improve preschoolers ' energy balance-related behaviours - including physical activity ( PA ) - by targeting the kindergarten environment and involving their parents/caregivers .
BACKGROUND	The present study aimed to examine the effect of the ToyBox-intervention on increasing Belgian preschoolers ' objectively measured PA levels .
METHODS	A sample of 472 preschoolers ( 4.43 0.55 years ; 55.1 % boys ) from 27 kindergartens ( 15 intervention , 12 control kindergartens ) in Flanders , Belgium were included in the data analyses .
METHODS	Preschoolers wore an ActiGraph accelerometer for six consecutive days and were included in the data analyses if they had a minimum of two weekdays and one weekend day , both at baseline and follow-up ( one year later ) .
METHODS	Preschoolers ' PA outcomes were estimated for an average day , weekday , weekend day , during school hours , and during after school hours .
METHODS	To assess intervention effects , multilevel repeated measures analyses were conducted for the total sample , and for sub-groups ( according to sex , kindergarten levels of socio-economic status ( SES ) and risk groups ( low levels of PA at baseline ) ) of preschoolers .
RESULTS	Small intervention effects were found in the total sample .
RESULTS	Most intervention effects were found in boys and in preschoolers from high SES kindergartens .
RESULTS	Boys from the intervention group had an increase in vigorous PA ( = 1.47 , p = 0.03 ) and moderate-to-vigorous PA ( = 1.27 , p = 0.03 ) from baseline to follow-up , whereas PA levels in boys from the control group stagnated or decreased .
RESULTS	In preschoolers from high SES kindergartens , the largest effects were found for PA outcomes during school hours and during after school hours .
CONCLUSIONS	The results from the Belgian sample demonstrate that effects of the PA-component of the ToyBox-intervention on objectively measured PA were found in preschool boys and in preschoolers from high SES kindergartens , which means that the ToyBox-intervention was mainly effective in those sub-groups .
CONCLUSIONS	Future interventions should search for alternative strategies to increase preschoolers ' PA levels in preschool girls and preschoolers from low SES kindergartens , as these are the most important at-risk groups regarding PA. .

###25127545
BACKGROUND	The World Health Organisation suggests that simplification of the medical abortion regime will contribute to an increased acceptability of medical abortion , among women as well as providers .
BACKGROUND	It is expected that a home-based follow-up after a medical abortion will increase the willingness to opt for medical abortion as well as decrease the workload and service costs in the clinic .
METHODS	This study protocol describes a study that is a randomised , controlled , non-superiority trial .
METHODS	Women screened to participate in the study are those with unwanted pregnancies and gestational ages equal to or less than nine weeks .
METHODS	The randomisation list will be generated using a computerized random number generator and opaque sealed envelopes with group allocation will be prepared .
METHODS	Randomization of the study participants will occur after the first clinical encounter with the doctor .
METHODS	Eligible women randomised to the home-based assessment group will use a low-sensitivity pregnancy test and a pictorial instruction sheet at home , while the women in the clinic follow-up group will return to the clinic for routine follow-up carried out by a doctor .
METHODS	The primary objective of the study this study protocol describes is to evaluate the efficacy of home-based assessment using a low-sensitivity pregnancy test and a pictorial instruction sheet 10-14 days after an early medical abortion .
METHODS	Providers or research assistants will not be blinded during outcome assessment .
METHODS	To ensure feasibility of the self-assessment intervention an adaption phase took place at the selected study sites before study initiation .
METHODS	This resulted in an optimized , tailor-made intervention and in the development of the pictorial instruction sheet with a guide on how to use the low-sensitivity pregnancy test and the danger signs after a medical abortion .
CONCLUSIONS	In this paper , we will describe the study protocol for a randomised control trial investigating the efficacy of simplified follow-up in terms of home-based assessment , 10-14 days after a medical abortion .
CONCLUSIONS	Moreover , a description of the adaptation phase is included for a better understanding of the implementation of the intervention in a setting where literacy is low and the road-connections are poor .
BACKGROUND	Clinicaltrials.gov NCT01827995 .
BACKGROUND	Registered 04 May 2013 .

###25226171
OBJECTIVE	The AeroChamber Plus ( AC ) valved holding chamber has been enhanced to include the Flow-Vu ( FV ) inspiratory flow indicator that provides visual inhalation feedback during use .
OBJECTIVE	We have investigated if FV alters asthma control and whether parents accept it .
METHODS	At visit 1 , children with asthma , age 1-5 years , used an AC with their pressurised metered dose inhaler and 2 weeks later ( visit 2 ) they were randomised to use either AC or FV .
METHODS	Subjects returned 6 ( visit 3 ) and 12 ( visit 4 ) weeks later .
METHODS	The Asthma Control ( ACQ ) and Paediatric Asthma Caregiver 's Quality of Life ( PACQLQ ) questionnaires were scored at each visit , and their peak inhalation flow ( PIF ) when they used their spacer was measured .
RESULTS	Forty participants in each group completed the study .
RESULTS	There was no difference in the ACQ scores from visits 2 to 4 between the two groups .
RESULTS	The improvements in the PACQLQ scores were greater in the FV group ( p = 0.029 ) .
RESULTS	The mean difference ( 95 % confidence interval ) for the change from visits 2 to 4 between FV and AC groups was 0.05 ( -0.33 , 0.43 ) and 0.39 ( 0.035 , 0.737 ) for the ACQ and PACQLQ , respectively .
RESULTS	Most parents preferred the FV ( p < 0.001 ) .
RESULTS	There was no difference in the PIF rates at each visit and between the two spacers .
CONCLUSIONS	There was no change in asthma control of the young children but that of their parents improved .
CONCLUSIONS	Parents preferred the FV and this could be related to their improved perception of their children 's asthma control by better PACQLQ scores .

###25266313
BACKGROUND	The adverse effects of inadvertent perioperative hypothermia in the surgical population are well established .
BACKGROUND	The aim of this study was to investigate whether a resistive warming mattress would reduce the incidence of inadvertent perioperative hypothermia in patients undergoing elective caesarean section .
METHODS	A total of 116 pregnant women booked for elective caesarean section were randomised to either intraoperative warming with a mattress or control .
METHODS	The primary outcome was the incidence of inadvertent perioperative hypothermia , defined as a temperature < 36.0 C on admission to the recovery room .
METHODS	Shivering in the perioperative period , severity of shivering and the need for treatment , total blood loss , fall in haemoglobin , incidence of blood transfusion , immediate health of baby , and length of hospital stay were also recorded .
RESULTS	The incidence of inadvertent perioperative hypothermia in the mattress-warmed group was significantly lower than in the control group ( 5.2 % vs. 19.0 % , P = 0.043 ) ; mean temperatures differed between the two groups , 36.5 C and 36.3 C , respectively ( P = 0.046 ) .
RESULTS	There was also a significantly lower mean ( SD ) haemoglobin change in the mattress-warmed group at -1.10.9 g/dL versus -1.60.9 g/dL in the control group ( P = 0.007 ) .
RESULTS	There was no difference in shivering ( P = 0.798 ) .
CONCLUSIONS	A resistive warming mattress reduced the incidence of inadvertent perioperative hypothermia and attenuated the fall in haemoglobin .
CONCLUSIONS	The use of resistive mattress warming should be considered during caesarean section .

###25464446
BACKGROUND	Exercise-based cardiac rehabilitation increases peak oxygen uptake ( peak VO ) , which is an important predictor of mortality in cardiac patients .
BACKGROUND	However , it remains unclear which exercise characteristics are most effective for improving peak VO in coronary artery disease ( CAD ) patients .
BACKGROUND	Proof of concept papers comparing Aerobic Interval Training ( AIT ) and Moderate Continuous Training ( MCT ) were conducted in small sample sizes and findings were inconsistent and heterogeneous .
BACKGROUND	Therefore , we aimed to compare the effects of AIT and Aerobic Continuous Training ( ACT ) on peak VO , peripheral endothelial function , cardiovascular risk factors , quality of life and safety , in a large multicentre study .
METHODS	Two-hundred CAD patients ( LVEF > 40 % , 90 % men , mean age 58.4 9.1 years ) were randomized to a supervised 12-week cardiac rehabilitation programme of three weekly sessions of either AIT ( 90-95 % of peak heart rate ( HR ) ) or ACT ( 70-75 % of peak HR ) on a bicycle .
METHODS	Primary outcome was peak VO ; secondary outcomes were peripheral endothelial function , cardiovascular risk factors , quality of life and safety .
RESULTS	Peak VO ( ml/kg/min ) increased significantly in both groups ( AIT 22.7 17.6 % versus ACT 20.3 15.3 % ; p-time < 0.001 ) .
RESULTS	In addition , flow-mediated dilation ( AIT +34.1 % ( range -69.8 to 646 % ) versus ACT +7.14 % ( range -66.7 to 503 % ) ; p-time < 0.001 ) quality of life and some other cardiovascular risk factors including resting diastolic blood pressure and HDL-C improved significantly after training .
RESULTS	Improvements were equal for both training interventions .
CONCLUSIONS	Contrary to earlier smaller trials , we observed similar improvements in exercise capacity and peripheral endothelial function following AIT and ACT in a large population of CAD patients .

###24706268
OBJECTIVE	Flexible nasolaryngoscopy is an essential skill for otolaryngology trainees to develop , but there is a lack of standardized training for this procedure .
OBJECTIVE	The aim of this study was to assess whether using training on a realistic human mannequin together with structured video feedback improved trainees ' performance at flexible nasolaryngoscopy .
METHODS	Three-armed , single-blinded , randomized controlled study .
METHODS	Thirty-six junior doctors and final-year medical students were randomly allocated to one of three groups .
METHODS	All received a lecture and video presentation on flexible nasolaryngoscopy .
METHODS	One group received additional tuition using a training mannequin .
METHODS	The last group received mannequin training and feedback on their performance using a video recording .
METHODS	The trainees then undertook flexible nasolaryngoscopy on volunteers with these endoscopies recorded .
METHODS	Blinded observers scored the trainees on a range of objective and subjective measures .
METHODS	The volunteers who were also blinded to the candidates ' training scored the comfort of the procedure .
RESULTS	Adding mannequin training showed a trend toward improvement of performance but did not reach statistical significance .
RESULTS	Mannequin training together with video feedback produced significant performance improvement in patient comfort ( P = .0065 ) , time to reach the vocal folds ( P = .017 ) , and global ability ( P = .0006 ) .
RESULTS	Inter-rater reliability was excellent with P < .01 in all assessments .
CONCLUSIONS	Simulation-based training using an anatomically correct model of the upper airway together with formalized video-assisted feedback on that training is a simple and effective way to improve endoscopy skills prior to starting flexible nasolaryngoscopy on patients .

###24627331
BACKGROUND	This study characterized a medically managed population in a non-ST-segment elevation acute coronary syndrome ( NSTEACS ) cohort and evaluated prognosis and outcomes of vorapaxar vs. placebo .
METHODS	In the TRACER study , 12,944 NSTEACS patients were treated with standard care and vorapaxar ( a novel platelet protease-activated receptor-1 antagonist ) or placebo .
METHODS	Of those , 4194 patients ( 32.4 % ) did not undergo revascularization during index hospitalization , and 8750 ( 67.6 % ) underwent percutaneous coronary intervention or coronary artery bypass grafting .
METHODS	Patients managed medically were heterogeneous with different risk profiles , including 1137 ( 27.1 % ) who did not undergo coronary angiography .
METHODS	Patients who underwent angiography but were selected for medical management included those without evidence of significant coronary artery disease ( CAD ) , with prior CAD but no new significant lesions , and with significant lesions who were not treated with revascularization .
RESULTS	Cardiovascular event rates were highest among those without angiography and lowest in the group with angiography but without CAD .
RESULTS	In the medically managed cohort , 2-year primary outcome ( cardiovascular death , myocardial infarction , stroke , recurrent ischaemia with rehospitalization , urgent coronary revascularization ) event rates were 16.3 % with vorapaxar and 17.0 % with placebo ( HR 0.99 , 95 % CI 0.83-1 .17 ) , with no interaction between drug and management strategy ( p = 0.75 ) .
RESULTS	Key secondary endpoint ( cardiovascular death , myocardial infarction , stroke ) rates were 13.4 % with vorapaxar and 14.9 % with placebo ( HR 0.89 , 95 % CI 0.74-1 .07 ) , with no interaction ( p = 0.58 ) .
RESULTS	Vorapaxar increased GUSTO moderate/severe bleeding numerically in medically managed patients ( adjusted HR 1.46 , 95 % CI 0.99-2 .15 ) .
CONCLUSIONS	NSTEACS patients who were initially medically managed had a higher risk-factor burden , and one-third had normal coronary arteries .
CONCLUSIONS	Outcome in the medically managed cohort was significantly related to degree of CAD , highlighting the importance of coronary angiography .
CONCLUSIONS	Efficacy and safety of vorapaxar appeared consistent with the overall trial results .

###24844862
BACKGROUND	The Totaled Health Risks in Vascular Events ( THRIVE ) score strongly predicts clinical outcome , mortality , and risk of thrombolytic haemorrhage in ischemic stroke patients , and performs similarly well in patients receiving intravenous tissue plasminogen activator , endovascular stroke treatment , or no acute treatment .
BACKGROUND	It is not known if the THRIVE score predicts outcomes with the Solitaire endovascular stroke treatment device .
OBJECTIVE	To validate the relationship between the THRIVE score and outcomes after treatment with the Solitaire endovascular stroke treatment device .
METHODS	The study conducted a retrospective analysis of the prospective SWIFT and STAR trials to examine the relationship between THRIVE and outcomes after treatment with the Solitaire device .
METHODS	We examined the relationship between THRIVE and clinical outcomes ( good outcome or death at 90days ) among patients in SWIFT and STAR .
METHODS	Receiver-operator characteristics curve analysis was used to compare THRIVE score performance with other stroke prediction scores .
METHODS	Multivariable modeling was used to confirm the independence of the THRIVE score from procedure-specific predictors ( successful recanalization or device used ) and other predictors of functional outcome .
RESULTS	The THRIVE score strongly predicts good outcome and death among patients treated with the Solitaire device in SWIFT and STAR ( Mantel-Haenszel chi-square test for trend P < 0001 for good outcome , P = 001 for death ) .
RESULTS	In receiver-operator characteristics ( ROC ) curve comparisons , totaled health risks in vascular events score is superior to Stroke Prognostication using Age and NIH Stroke Scale score-100 ( P < 0001 ) and performed similarly to Houston Intra-Arterial Therapy score ( HIAT ) ( P = 098 ) and HIAT-2 ( P = 054 ) .
RESULTS	In multivariable models , THRIVE 's prediction of good outcome is not altered after controlling for recanalization or after controlling for device used .
RESULTS	The THRIVE score remains a strong independent predictor after controlling for the above predictors together with time to procedure , rate of symptomatic haemorrhage , and use of general anesthesia .
RESULTS	Of note , use of general anesthesia was not an independent predictor of outcome in SWIFT+STAR after controlling for totaled health risks in vascular events and other factors .
CONCLUSIONS	The THRIVE score strongly predicts clinical outcome and mortality in patients treated with the Solitaire device in the SWIFT and STAR trials .
CONCLUSIONS	The lack of interaction between THRIVE and procedure-specific elements such as vessel recanalization or device choice makes the THRIVE score a reasonable candidate for use as a patient selection criterion in stroke clinical trials .

###24855129
BACKGROUND	Individual placement and support ( IPS ) is effective in helping patients return to work but is poorly implemented because of clinical ambivalence and fears of relapse .
OBJECTIVE	To assess whether a motivational intervention ( motivational interviewing ) directed at clinical staff to address ambivalence about employment improved patients ' occupational outcomes .
METHODS	Two of four early intervention teams that already provided IPS were randomised to receive motivational interviewing training for clinicians , focused on attitudinal barriers to employment .
METHODS	The trial was registered with the International Standard Randomised Controlled Trial Register ( ISRCTN71943786 ) .
RESULTS	Of 300 eligible participants , 159 consented to the research .
RESULTS	Occupational outcomes were obtained for 134 patients ( 85 % ) at 12-month follow-up .
RESULTS	More patients in the intervention teams than in the IPS-only teams achieved employment by 12 months ( 29/68 v. 12/66 ) .
RESULTS	A random effects logistic regression accounting for clustering by care coordinator , and adjusted for participants ' gender , ethnicity , educational and employment history and clinical status scores , confirmed superiority of the intervention ( odds ratio = 4.3 , 95 % CI 1.5-16 .6 ) .
CONCLUSIONS	Employment outcomes were enhanced by addressing clinicians ' ambivalence about their patients returning to work .

###26387891
BACKGROUND	Lower body negative pressure ( LBNP ) decreases middle cerebral artery blood velocity ( MCAv ) and can induce hypotension .
BACKGROUND	Mental stress increases MCAv , but the MCAv response to combined LBNP and mental stress ( COMBO ) is unknown .
BACKGROUND	We hypothesized that performing a stressful cognitive challenge ( i.e. , mental stress ) concurrently with LBNP would prevent LBNP-induced reductions of MCAv .
METHODS	There were 18 subjects ( 9 men , 9 women ; ages 20.10.3 yr ) who completed 3 randomized 3-min trials : 1 ) LBNP ( -40 mmHg ) ; 2 ) mental stress ( serial subtraction ) ; and 3 ) COMBO ( LBNP + mental stress ) .
METHODS	All reported values are meanSE .
METHODS	Mean arterial pressure ( MAP ) , heart rate ( HR ) , forearm blood flow ( FBF ) , and MCAv were measured continuously .
METHODS	Subjects also reported perceived stress following the mental stress and COMBO trials .
RESULTS	LBNP decreased MAP ( -1.40.5 mmHg ) , MCAv ( -2.61.1 cm s ( -1 ) ) and FBF ( -0.80.1 units ) , and increased HR ( 2.71.2 bpm ) .
RESULTS	Mental stress increased MAP ( 10.11.3 mmHg ) , HR ( 17.42.2 bpm ) , and FBF ( 2.40.4 units ) , while MCAv ( 2.81.3 cm s ( -1 ) ) tended to increase .
RESULTS	COMBO increased MAP ( 5.32.3 mmHg ) and HR ( 21.32.6 bpm ) , and tended to increase FBF ( 0.50.3 units ) .
RESULTS	However , MCAv ( -4.62.0 cm s ( -1 ) ) decreased during COMBO .
RESULTS	Decreases in MCAv during COMBO were not statistically different from LBNP-induced decreases ( -4.62.0 vs. -2.61.1 cm s ( -1 ) ) .
RESULTS	Subjective ratings of perceived stress ( standard 0 to 4 scale ) tended to be higher during COMBO than mental stress ( 2.90.1 vs. 2.50.1 units ) .
CONCLUSIONS	Our results suggest that mental stress does not effectively preserve MCAv when combined with central hypovolemia ( i.e. , LBNP ) .

###26075853
BACKGROUND	A number of clinical trials have shown that patients with overt atherovascular disease may benefit from more aggressive dosage of statins .
BACKGROUND	We aimed to determined the usual dosage of statin in clinical practice and the adherence to recommended target concentration of LDL-cholesterol .
RESULTS	We analyzed 948 patients with mean age 64.5 years ( SD 9.0 ) after acute coronary syndrome and/or coronary revascularization ( Czech samples of EUROASPIRE III and IV ) .
RESULTS	In spite that more than 93 % of patients were in 2012/2013 treated with statin , only 2.4 % with the highest dose ( atorvastatin 80 mg or equivalent ) .
RESULTS	On the other hand , medium-dosed statin ( atorvastatin 40 mg ) was more often prescribed , in comparison to 2006/2007 .
RESULTS	We observed mild improvement in adherence to former LDL-cholesterol target < 2.5 mmol/l ( from 54 % to 65 % ) , but the recent target < 1.8 mmol/l was reached only in less than one quarter of patients in 2012/2013 .
RESULTS	It can be approximate ( using individual LDL-cholesterol values ) , that after maximal possible up-titration of statin , the adherence to recent LDL-cholesterol target may improve up to 43 % .
CONCLUSIONS	Although the majority of CHD patients are currently being treated with statin , the usual dosage regimen and adherence to the recommended target values were not consistent with current therapeutic standards for secondary prevention of CHD .

###24452658
BACKGROUND	Among the multiple nonsurgical modalities , epidural injections are one of the most commonly utilized treatment modalities in managing chronic low back and lower extremity pain due to disc herniation and radiculitis .
BACKGROUND	There is a paucity of randomized trials from contemporary interventional pain management settings utilizing fluoroscopy with long-term follow-up .
METHODS	Randomized , double-blind , active-controlled trial with 2-year follow-up .
METHODS	An interventional pain management practice in the United States .
OBJECTIVE	The objective was to assess the effectiveness of lumbar interlaminar epidural injections of local anesthetic with or without steroids for managing chronic low back pain of disc herniation or radiculitis .
METHODS	Two groups of patients were studied , with 60 patients in each group receiving either local anesthetic only or local anesthetic mixed with betamethasone .
METHODS	The primary outcome measure was defined as pain relief and functional status improvement of 50 % .
METHODS	The outcomes were assessed by numeric rating scale ( NRS ) of pain and functional status with Oswestry Disability Index ( ODI ) .
METHODS	Secondary outcome measures included employment status and opioid intake .
RESULTS	Results showed significant improvement in 60 % of patients in Group I and 70 % of patients in Group II at the end of 2 years .
RESULTS	In addition , in the successful groups , those with at least 3 weeks of relief ( with the first 2 procedures ) , the improvement was 72 % in Group I and 71 % in Group II .
RESULTS	Results were somewhat superior for pain relief at 6 months and functional status at 12 months in the steroid group .
RESULTS	Thus , the results indicate that a patient 's failure to respond to local anesthetic alone , may be treated with addition of steroids .
CONCLUSIONS	The results of the study are limited by the lack of a placebo group .
CONCLUSIONS	Lumbar interlaminar epidural injections of local anesthetic with or without steroids is an effective modality , in patients with chronic function limiting low back and lower extremity pain secondary to disc herniation after failure of conservative modalities .

###25175985
BACKGROUND	Distal radius fractures are among the most common fractures and account for approximately one-sixth of all fractures diagnosed .
BACKGROUND	Therapy results after distal radius fracture , especially of elderly patients , are often suboptimal .
BACKGROUND	The inevitable immobilization for several weeks leads to reduction in range of motion , deterioration of muscle strength , malfunction of fine motor skills as well as changes of motor and sensory representations in the brain .
BACKGROUND	Currently , there are no strategies to counteract these immobilization problems .
BACKGROUND	The overall aim of the study is to investigate the therapeutic potential of motor-cognitive approaches ( mental practice or mirror therapy ) on hand function after wrist fracture .
METHODS	This study is a controlled , randomized , longitudinal intervention study with three intervention groups .
METHODS	One experimental group imagines movements of the fractured upper extremity without executing them ( mental practice ) .
METHODS	The second experimental group receives a mirror therapy program consisting of the performance of functional movement synergies using the unaffected forearm , wrist , and hand .
METHODS	The control group completes a relaxation training regime .
METHODS	Additionally , all patients receive usual care by the general practitioner .
METHODS	We include women aged 60 years and older having a distal radius fracture and sufficient cognitive function .
METHODS	All groups are visited at home for therapy sessions 5 times per week for the first 3 weeks and 3 times per week for weeks 4 to 6 .
METHODS	Measurements are taken at therapy onset , and after 3 , 6 and 12 weeks .
METHODS	The primary outcome measure will assess upper extremity functioning ( Patient-Rated Wrist Evaluation [ PRWE ] ) , while secondary outcome measures cover subjective wrist function ( Disabilities of the Arm and Shoulder ; [ DASH ] , objective impairment ( range of motion , grip force ) and quality of life ( EuroQol-5D , [ EQ5D ] ) .
CONCLUSIONS	Results from this trial will contribute to the evidence on motor-cognitive approaches in the early therapy of distal radius fractures .
BACKGROUND	The trial is registered at ClinicalTrials.gov with registration number NCT01394809 and was granted permission by the Medical Ethical Review Committee of the University of Tbingen in June 2011 .

###25272321
OBJECTIVE	We evaluated eating behaviors and quality of life ( QOL ) in preadolescent children at risk for obesity , with and without abdominal pain ( AP ) .
METHODS	Participants were parent-child dyads enrolled in a randomized , controlled obesity prevention trial .
METHODS	The children were between 5 and 10 years of age and at risk for obesity ( 70th-95th percentile of body mass index , n = 420 ) .
METHODS	Parents completed measures of their child 's eating behaviors , QOL , AP , and bowel function and their own depression status , concern about child weight , and feeding practices .
METHODS	Children 's height and weight were also measured .
RESULTS	Children with frequent AP ( 2/month , n = 103 ) were compared with children reporting infrequent AP ( < 2/month , n = 312 ) .
RESULTS	Age and body mass index did not differ between groups , but AP was more prevalent in girls .
RESULTS	Child emotional overeating and parental depression scores were higher in the frequent AP group ( P < 0.01 ) , and child QOL was lower ( P < 0.01 ) .
RESULTS	In multivariable analysis , female gender ( odds ratio [ OR ] 2.18 , 95 % confidence interval [ CI ] 1.20-3 .97 ) , emotional overeating ( OR 2.28 , 95 % CI 1.37-3 .81 ) , and parental depression ( OR 1.23 , 95 % CI 1.12-1 .35 ) were associated with more frequent AP .
RESULTS	Secondary analyses were completed for children who met Rome III criteria for irritable bowel syndrome .
CONCLUSIONS	Clinicians working with children with AP at risk for obesity should consider assessing for and , when appropriate , addressing parent and child factors that could exacerbate AP .

###25425539
OBJECTIVE	The efficacy of macrolides in chronic rhinosinusitis ( CRS ) is still under controversy .
OBJECTIVE	To date , only two double-blind , placebo-controlled studies have been published with differing results .
OBJECTIVE	None of these studies investigated the possible benefit of macrolides in the postoperative period .
OBJECTIVE	We conducted an investigator-initiated clinical trial using 250-mg erythromycin once a day over a period of 3 months , beginning the administration of either erythromycin or placebo 2 weeks after a surgical intervention for CRS .
METHODS	Randomized double-blind , placebo-controlled trial .
METHODS	The concentrations of eosinophilic cationic protein ( ECP ) and myeloperoxidase in nasal secretion were chosen as primary outcome measures .
METHODS	Additionally , as a secondary outcome measure , changes in the Sino-Nasal Outcome Test-20 score , olfaction , saccharin transit time , nasal endoscopy score , and self-rating of nasal health using a visual analogue scale were evaluated .
RESULTS	Sixty-seven patients after surgery for CRS with or without nasal polyps were screened , and 58 patients were randomized to the study groups .
RESULTS	For the primary outcomes , the concentrations of ECP changed from 176.4 l/l79 .0 to 226.1 l/l200 .6 in the erythromycin group and from 186.9 l/l36 .0 to 192.9 l/l189 .2 in the placebo group ; no statistical differences were found .
RESULTS	Of the secondary outcomes , only the nasal endoscopy score showed a statistically significant improvement in the erythromycin group ( from 2.61.4 to 1.91.5 points ) compared to the placebo group ( from 2.51.3 to 2.61.5 points ) .
RESULTS	The subgroup of patients without nasal polyps in the erythromycin group showed a tendency to improvement in some secondary outcome criteria .
CONCLUSIONS	A general recommendation for long-term , low-dose erythromycin treatment after surgery for CRS can not be given .
CONCLUSIONS	In patients with CRS without nasal polyps , a tendency to improved parameters was detected .
METHODS	Ib .

###24766987
OBJECTIVE	The purpose of this study is to evaluate the effects of an 8-week exercise-based cardiac rehabilitation program on traditional and nonlinear heart rate variability ( HRV ) indexes , assessing the potential confounding influences of habitual physical activity ( PA ) and dietary intake .
METHODS	In this parallel-group trial , 96 patients ( 56 10 years old ) were randomized to the exercise group ( EG ) or to the control group ( CG ) 4 weeks after an acute myocardial infarction .
METHODS	Exercise-based cardiac rehabilitation program consisted of aerobic exercise at 70 % to 85 % of maximal heart rate for 3 sessions per week plus usual care .
METHODS	The CG received only usual care .
METHODS	The baseline and final assessments comprised resting short-term HRV ( primary outcome ) by a Polar R-R recorder under controlled breathing ( 12 breaths per minute ) , habitual PA by accelerometers , and dietary intake by a 4-day food diary .
RESULTS	Two patients in each group dropped out and were not included in the intention-to-treat analysis .
RESULTS	In the remaining 92 patients ( EG = 47 and CG = 45 ) , at baseline , only a difference in the proportion of nitrate medication use was significant between groups .
RESULTS	After 8 weeks , no significant changes were found between groups on traditional and nonlinear HRV indexes ( eg , ln HF , EG from 5.7 1.5 to 5.9 1.3 and CG from 5.5 1.6 to 5.5 1.5 ) , habitual PA , and dietary intake .
CONCLUSIONS	Eight weeks of exercise-based cardiac rehabilitation program is an insufficient stimulus to improve cardiac autonomic function in post-myocardial infarction patients under optimal medication and with high levels of traditional and nonlinear HRV indexes at baseline .

###25332478
BACKGROUND	The modulation of gut microbiota is considered to be the first target to establish probiotic efficacy in a healthy population .
OBJECTIVE	This study was conducted to determine the impact of a probiotic on the intestinal microbial ecology of healthy volunteers .
METHODS	High-throughput 16S ribosomal RNA gene sequencing was used to characterize the fecal microbiota in healthy adults ( 23-55 y old ) of both sexes , before and after 4 wk of daily consumption of a capsule containing at least 24 billion viable Lactobacillus paracasei DG cells , according to a randomized , double-blind , crossover placebo-controlled design .
RESULTS	Probiotic intake induced an increase in Proteobacteria ( P = 0.006 ) and in the Clostridiales genus Coprococcus ( P = 0.009 ) , whereas the Clostridiales genus Blautia ( P = 0.036 ) was decreased ; a trend of reduction was also observed for Anaerostipes ( P = 0.05 ) and Clostridium ( P = 0.06 ) .
RESULTS	We also found that the probiotic effect depended on the initial butyrate concentration .
RESULTS	In fact , participants with butyrate > 100 mmol/kg of wet feces had a mean butyrate reduction of 49 21 % and a concomitant decrease in the sum of 6 Clostridiales genera , namely Faecalibacterium , Blautia , Anaerostipes , Pseudobutyrivibrio , Clostridium , and Butyrivibrio ( P = 0.021 ) , after the probiotic intervention .
RESULTS	In contrast , in participants with initial butyrate concentrations < 25 mmol/kg of wet feces , the probiotic contributed to a 329 255 % ( mean SD ) increment in butyrate concomitantly with an 55 % decrease in Ruminococcus ( P = 0.016 ) and a 150 % increase in an abundantly represented unclassified Bacteroidales genus ( P = 0.05 ) .
CONCLUSIONS	The intake of L. paracasei DG increased the Blautia : Coprococcus ratio , which , according to the literature , can potentially confer a health benefit on the host .
CONCLUSIONS	The probiotic impact on the microbiota and on short-chain fatty acids , however , seems to strictly depend on the initial characteristics of the intestinal microbial ecosystem .
CONCLUSIONS	In particular , fecal butyrate concentrations could represent an important biomarker for identifying subjects who may benefit from probiotic treatment .
CONCLUSIONS	This trial was registered at www.controlled-trials.com/isrctn as ISRCTN56945491 .

###24446755
BACKGROUND	Vitiligo is an acquired skin disorder with great social impact .
BACKGROUND	It can be successfully treated using cultured autologous melanocytes transplantation .
OBJECTIVE	To evaluate the effect of different modalities of narrow-band ultraviolet B ( NB-UVB ) therapy on the outcome of cultured autologous melanocyte transplantation in treating vitiligo .
METHODS	Patients undergoing cultured autologous melanocyte transplantation were randomly assigned to four different study groups .
METHODS	Group 1 underwent 20 sessions of NB-UVB treatment before transplantation ; Group 2 underwent 30 sessions of NB-UVB treatment after transplantation ; Group 3 underwent 20 sessions of NB-UVB treatment before transplantation and 30 sessions after transplantation ; Group 4 underwent only transplantation .
RESULTS	Four hundred thirty-seven patients were enrolled .
RESULTS	Group 3 responded best , more than 90 % repigmentation was achieved in 81.3 % of patients , and 94.8 % patients experienced 50 % or greater repigmentation .
RESULTS	Statistical analysis showed that there was a highly significant difference between the four groups ( ( 2 ) = 35.56 , p < .001 ) .
RESULTS	Homogeneous skin color was obtained on the repigmentation areas , and no scarring or other serious side effects were observed .
CONCLUSIONS	Cultured autologous melanocyte transplantation is an effective treatment for stable vitiligo .
CONCLUSIONS	Combination of NB-UVB therapy with melanocyte transplantation can accelerate repigmentation of transplanted vitiliginous areas , especially if NB-UVB is given before and after transplantation .

###24231273
OBJECTIVE	To assess whether interspinous process device implantation is more effective in the short term than conventional surgical decompression for patients with intermittent neurogenic claudication due to lumbar spinal stenosis .
METHODS	Randomized controlled trial .
METHODS	Five neurosurgical centers ( including one academic and four secondary level care centers ) in the Netherlands .
METHODS	203 participants were referred to the Leiden-The Hague Spine Prognostic Study Group between October 2008 and September 2011 ; 159 participants with intermittent neurogenic claudication due to lumbar spinal stenosis at one or two levels with an indication for surgery were randomized .
METHODS	80 participants received an interspinous process device and 79 participants underwent spinal bony decompression .
METHODS	The primary outcome at short term ( eight weeks ) and long term ( one year ) follow-up was the Zurich Claudication Questionnaire score .
METHODS	Repeated measurements were made to compare outcomes over time .
RESULTS	At eight weeks , the success rate according to the Zurich Claudication Questionnaire for the interspinous process device group ( 63 % , 95 % confidence interval 51 % to 73 % ) was not superior to that for standard bony decompression ( 72 % , 60 % to 81 % ) .
RESULTS	No differences in disability ( Zurich Claudication Questionnaire ; P = 0.44 ) or other outcomes were observed between groups during the first year .
RESULTS	The repeat surgery rate in the interspinous implant group was substantially higher ( n = 21 ; 29 % ) than that in the conventional group ( n = 6 ; 8 % ) in the early post-surgical period ( P < 0.001 ) .
CONCLUSIONS	This double blinded study could not confirm the hypothesized short term advantage of interspinous process device over conventional `` simple '' decompression and even showed a fairly high reoperation rate after interspinous process device implantation .
BACKGROUND	Dutch Trial Register NTR1307 .

###24766758
OBJECTIVE	Despite the increasing need to identify and implement effective interventions to reduce drinking with mandated college students , peer-led brief alcohol interventions have received minimal research attention .
OBJECTIVE	The current pilot study tested whether enhanced supervision ( evidence-based application approach [ EAA ; group plus individual ] ) would improve peer counseling skills beyond those acquired by a common practice approach ( CPA ; group only ) .
METHODS	Following initial peer counselor skill evaluation , drinking outcomes after intervention were compared between supervision groups with a mandated college student sample ( N = 82 ; 65 men ) .
METHODS	The relationship between acquired motivational interviewing skills and subsequent drinking behaviors was also assessed .
RESULTS	EAA peer counselors showed higher motivational interviewing skill acquisition than CPA peer counselors .
RESULTS	Despite differences in counselor skill demonstration , mandated clients in both intervention groups significantly reduced drinking behaviors .
RESULTS	Further , higher reflection-to-question ratio and motivational interviewing spirit demonstrated by peer counselors were significantly related to poorer follow-up drinking outcomes .
CONCLUSIONS	Findings identify supervision practices that may result in optimal peer counselor learning and brief intervention implementation while also offering initial data about the way in which peer counseling session implementation may relate to drinking outcomes .
CONCLUSIONS	Future research is needed to identify the within-session processes of peer-led interventions that predict drinking outcomes , which may offer additional direction for training approaches .

###25371542
BACKGROUND	It is estimated that up to two thirds of patients presenting with ST-segment-elevation myocardial infarction have multivessel disease .
BACKGROUND	The optimal strategy for treating nonculprit disease is currently under debate .
BACKGROUND	This study provides a real-world analysis comparing a strategy of culprit-vessel intervention ( CVI ) versus multivessel intervention at the time of primary percutaneous coronary intervention in patients with ST-segment-elevation myocardial infarction .
RESULTS	We compared CVI versus multivessel intervention in 3984 patients with multivessel disease undergoing primary percutaneous coronary intervention between 2004 and 2011 at all 8 tertiary cardiac centers in London .
RESULTS	Multivariable-adjusted models were built to determine independent predictors for in-hospital major adverse cardiovascular events ( MACEs ) and all-cause mortality at 1 year .
RESULTS	To reduce confounding and bias , propensity score methods were used .
RESULTS	CVI was associated with reduced in-hospital MACE ( 4.6 % versus 7.2 % ; P = 0.010 ) and mortality at 1 year ( 7.4 % versus 10.1 % ; P = 0.031 ) .
RESULTS	CVI was an independent predictor for reduced in-hospital MACE ( odds ratio , 0.49 ; 95 % confidence interval [ CI ] , 0.32-0 .75 ; P < 0.001 ) and survival at 1 year ( hazard ratio , 0.65 ; 95 % CI , 0.47-0 .91 ; P = 0.011 ) in the complete cohort ; and in 2821 patients in propensity-matched cohort ( in-hospital MACE : odds ratio , 0.49 ; 95 % CI , 0.32-0 .76 ; P = 0.002 ; and 1-year survival : hazard ratio , 0.64 ; 95 % CI , 0.45-0 .90 ; P = 0.010 ) .
RESULTS	Inverse probability treatment weighted analyses also confirmed CVI as an independent predictor for reduced in-hospital MACE ( odds ratio , 0.38 ; 95 % CI , 0.15-0 .96 ; P = 0.040 ) and survival at 1 year ( hazard ratio , 0.44 ; 95 % CI , 0.21-0 .93 ; P = 0.033 ) .
CONCLUSIONS	In this observational analysis of patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention , CVI was associated with increased survival at 1 year .
CONCLUSIONS	Acknowledging the limitations with observational analyses , our findings support current recommended practice guidelines .

###24524676
BACKGROUND	In 2006 there were 432,700 people in Australia who had acquired brain injury ( ABI ) with some limitation of activities ; 90 % of these were traumatic brain injuries ( TBIs ) and nearly a third sustained injury below age 15years .
BACKGROUND	One to four years post injury , 20 % to 46 % of children with traumatic brain injury ( TBI ) have clinically significant disorders of attention .
BACKGROUND	There is controversy as to whether central nervous system ( CNS ) stimulants can be an effective method of treating these.Objectives were to determine the efficacy of CNS stimulants for children with TBI , and to calculate the sample size for a larger trial using the Conners ' 3 Parent Rating Scales Score as the primary endpoint .
METHODS	Pilot series of aggregated prospective randomised , double-blind , n-of-1 trials of stimulant versus placebo within individual patients .
METHODS	tertiary children 's public hospital .
METHODS	ten children aged 6 to 16years more than 12months post TBI with attention , concentration and behavioral difficulties on stimulants .
METHODS	Three cycles of methylphenidate or dexamphetamine orally at doses titrated by physician compared to placebo .
METHODS	Conners 3 Parent ( Conners 3-P ) and Teacher ( Conners 3-T ) Rating Scales ( Global Index ) , Behaviour Rating Inventory of Executive Function ( BRIEF ) and Eyberg Child Behaviour Inventory ( ECBI ) .
RESULTS	Five of ten patients completed the study .
RESULTS	Data from 18 completed cycles from seven patients were analysed .
RESULTS	The posterior mean difference between stimulant and placebo scores for the Conners 3-PS ( Global Index ) was 2.3 ( SD 6.2 ; 95 % credible region -1.0 to 6.1 ; posterior probability that this mean difference was greater than zero was 0.92 ) , and for the Conners 3-T ( Global Index ) the posterior mean difference was 5.9 ( SD 4.5 ; 95 % credible region -3.1 to 14.9 ; posterior probability 0.93 ) .
RESULTS	Posterior mean differences suggest improvement in behaviour and executive function and a decrease in number and intensity of child behaviour problems when taking stimulants compared to placebo .
RESULTS	Taken together these data are suggestive of a small benefit at group level .
CONCLUSIONS	In this pilot study , there was sufficient evidence that stimulants may be useful in management of behavioral and cognitive sequelae following TBI , to warrant a larger trial .
BACKGROUND	he trial was registered with the Australian and New Zealand Clinical Trials Registry : registration number ACTRN12609000873224 .

###25908190
OBJECTIVE	To investigate the effects of maxillary protraction combined with repetitive rapid palatal expansions and constrictions ( RPE/C ) vs. rapid palatal expansion ( RPE ) alone using cone-beam computed tomography ( CBCT ) .
METHODS	Twenty four subjects with maxillary retrusion were recruited and block randomized into either the control group ( n = 12 ) or the RPE/C ( n = 12 ) group .
METHODS	facemask protraction after RPE .
METHODS	RPE/C group : facemask protraction after RPE/C .
METHODS	3D reconstruction , landmarks identifying , superimposition and cephalometric analysis were performed to compare the pre-treatment and post - treatment CBCT images .
RESULTS	One subject in the RPE/C group was lost to follow up during the treatment .
RESULTS	Maxilla moved forward [ ( 2.51.0 ) mm ] after maxillary protraction with RPE/C , which was significantly greater than that in the control group [ ( 1.60.8 ) mm ] ( P < 0.05 ) .
RESULTS	The distance of basion to subspinale ( Ba-A ) increased [ ( 3.11.0 ) mm ] in the RPE/C group , which was significantly greater than that in the control group [ ( 2.2 0.9 ) mm ] ( P < 0.05 ) .
RESULTS	The amount of forward movement of upper first molars was significantly greater in the RPE/C group ( P < 0.05 ) .
CONCLUSIONS	Maxillary protraction with RPE/C might positively affect the forward movement of maxilla compared with the RPE alone protocol with the early treatment of maxillary retrusion patients .

###24794721
BACKGROUND	Subcutaneous pegylated interferon ( peginterferon ) beta-1a is being developed for treatment of relapsing multiple sclerosis , with less frequent dosing than currently available first-line injectable treatments .
BACKGROUND	We assessed the safety and efficacy of peginterferon beta-1a after 48 weeks of treatment in the placebo-controlled phase of the ADVANCE trial , a study of patients with relapsing-remitting multiple sclerosis .
METHODS	We did this 2-year , double-blind , parallel group , phase 3 study , with a placebo-controlled design for the first 48 weeks , at 183 sites in 26 countries .
METHODS	Patients with relapsing-remitting multiple sclerosis ( age 18-65 years , with Expanded Disability Status Scale score 5 ) were randomly assigned ( 1:1:1 ) via an interactive voice response or web system , and stratified by site , to placebo or subcutaneous peginterferon beta-1a 125 g once every 2 weeks or every 4 weeks .
METHODS	The primary endpoint was annualised relapse rate at 48 weeks .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00906399 .
RESULTS	We screened 1936 patients and enrolled 1516 , of whom 1512 were randomly assigned ( 500 to placebo , 512 to peginterferon every 2 weeks , 500 to peginterferon every 4 weeks ) ; 1332 ( 88 % ) patients completed 48 weeks of treatment .
RESULTS	Adjusted annualised relapse rates were 0397 ( 95 % CI 0328-0481 ) in the placebo group versus 0256 ( 0206-0318 ) in the every 2 weeks group and 0288 ( 0234-0355 ) in the every 4 weeks group ( rate ratio for every 2 weeks group 0644 , 95 % CI 0500-0831 , p = 00007 ; rate ratio for the every 4 weeks group 0725 , 95 % CI 0565-0930 , p = 00114 ) .
RESULTS	417 ( 83 % ) patients taking placebo , 481 ( 94 % ) patients taking peginterferon every 2 weeks , and 472 ( 94 % ) patients taking peginterferon every 4 weeks reported adverse events including relapses .
RESULTS	The most common adverse events associated with peginterferon beta-1a were injection site reactions , influenza-like symptoms , pyrexia , and headache .
RESULTS	76 ( 15 % ) patients taking placebo , 55 ( 11 % ) patients taking study drug every 2 weeks , and 71 ( 14 % ) patients taking study drug every 4 weeks reported serious adverse events ; relapse , pneumonia , and urinary tract infection were the most common .
CONCLUSIONS	After 48 weeks , peginterferon beta-1a significantly reduced relapse rate compared with placebo .
CONCLUSIONS	The drug might be an effective treatment for relapsing-remitting multiple sclerosis with less frequent administration than available treatments .
BACKGROUND	Biogen Idec .

###25351561
METHODS	This randomized , double-blind , and placebo-controlled trial evaluated the effect of isolated daidzein and genistein on glycemic control and insulin sensitivity in 165 Chinese women aged 30-70 with impaired glucose regulation ( IGR ) .
RESULTS	Participants were randomly assigned to one of three groups with a daily dose of 10 g of soy protein plus ( i ) no addition , ( ii ) 50 mg of daidzein , or ( iii ) 50 mg of genistein for 24 wk .
RESULTS	Fasting glucose ( FG ) , insulin , and glycosylated hemoglobin ( HbA1c ) , and glucose concentrations at 30 , 60 , 120 , and 180 min and insulin concentrations at 30 , 60 , and 120 min after an oral 75-g glucose tolerance test were assessed at baseline and at 12 and 24 wk postintervention .
RESULTS	a total of 158 and 151 subjects completed the measures at wk 12 and 24 , respectively .
RESULTS	There were no significant differences in the changes ( % ) of FG and the 2-h glucose , HbA1c , fasting , and 2-h insulin or the area under the curve of glucose and insulin between the three treatment groups at wk 12 or 24 ( all p > 0.05 ) .
CONCLUSIONS	Neither isolated daidzein nor genistein has a significant effect on glycemic control and insulin sensitivity in Chinese women with IGR over a 6-month supplementation period .

###25458331
BACKGROUND	Although there have been several reports that statins cause insulin resistance that leads to the occurrence of type 2 diabetes in Caucasians , there has been no Japanese prospective studies investigating the effects of statins on the glucose metabolism system .
METHODS	Our subjects were 86 Japanese patients with type 2 diabetes with hypercholesterolemia .
METHODS	Pitavastatin 2mg/day was administered for 12 months and the lipid-related values , glucose metabolism values , and the presence/absence of side effects were investigated .
RESULTS	None of these factors was found to differ between before and after administration of pitavastatin in overall analysis of all subjects .
RESULTS	In subgroup analysis , fasting blood glucose showed a decrease in the BMI 25 group and there was a significant difference between the BMI < 25 and BMI 2 5 groups ( P-values : 0.021 and 0.0036 ) .
RESULTS	Although HbA1c showed an increase both in the group switched to pitavastatin and the BMI < 25 group ( P-values : 0.035 and 0.033 ) and HOMA - showed a decrease in the BMI < 25 group ( P-values : 0.044 ) , there were no significant differences in changes between each divided group and their counterparts .
CONCLUSIONS	In the Japanese obese group with BMI 25 , pitavastatin elicited a significant decrease in fasting blood glucose .
CONCLUSIONS	It is not clear whether or not this is due to improved insulin resistance as a direct effect of pitavastatin , but in contrast to findings in Caucasians pitavastatin does not worsen insulin resistance in Japanese patients with type 2 diabetes complicated by hypercholesterolemia .

###24295006
OBJECTIVE	The aim of this in vitro study is to evaluate the effects of three different caries removal techniques on the microtensile bond strength of adhesive materials to caries-affected dentin .
METHODS	Thirty primary molar teeth were used .
METHODS	The teeth were randomly divided into three groups according to the caries removal technique employed : conventional steel bur ( group 1 ) ; Er : YAG laser ( group 2 ) ; chemomechanical method ( group 3 ) .
METHODS	Each group was divided into two subgroups according to bonding agents : one-step self-etch adhesive and etch-and-rinse adhesive .
METHODS	The teeth were restored with composite resin .
METHODS	Vertical sticks were obtained and subjected to tensile stress .
METHODS	Data were analyzed by two-way analysis of variance ( ANOVA ) , Tukey 's test and an independent samples t-test .
RESULTS	The values for the laser groups were significantly lower than those of the bur groups for both bonding agents ( p < 0.05 ) .
RESULTS	There were no significant differences between the bur and chemomechanical groups ( p > 0.05 ) .
CONCLUSIONS	Bur and chemomechanical techniques in primary teeth were found more successful .
CONCLUSIONS	Similar results were found according to the adhesives used for each caries removal techniques .

###24481930
OBJECTIVE	The administration of single dose intrathecal ( IT ) morphine with local anesthetics during spinal anesthesia produces an effective postoperative analgesia .
OBJECTIVE	In this study , we evaluated the efficacy and safety of two different doses of IT morphine with bupivacaine for postoperative analgesia after transurethral resection of prostate ( TURP ) .
METHODS	Prospective , randomized study .
METHODS	Urology Department .
METHODS	Sixty patients who were scheduled to undergo TURP with spinal anesthesia .
METHODS	Patients were allocated to receive IT morphine ( 75 g ) with bupivacaine heavy ( group I ) and IT morphine ( 150 g ) with bupivacaine heavy ( group II ) .
METHODS	Postoperative pain was evaluated by Visual Analogous Scale during 24 hours .
METHODS	The need for rescue analgesia , adverse effects and patient satisfaction were recorded .
RESULTS	Groups were comparable with respect to demographic data .
RESULTS	VAS scores were similarly low in both groups .
RESULTS	However , the request for analgesia was significantly higher in group I ( 27 percent ) than group II ( 7 percent ; p = 0.04 ) .
RESULTS	The incidence of postoperative nausea was similarly low in both groups .
RESULTS	No patients reported pruritis in group I where as six patients ( 20 percent ) reported mild pruritis not necessitating treatment in group II ( p = 0.036 ) Patients satisfaction was similarly high in both the groups .
CONCLUSIONS	IT morphine 150 g reduced the need for rescue analgesia compared to IT morphine 75 g in patients undergoing TURP under spinal anesthesia .
CONCLUSIONS	As the incidence of pruritis was low with no treatment , IT morphine 150 g may be a suitable dose for postoperative analgesia for patients undergoing TURP under spinal anesthesia .

###25881022
BACKGROUND	Specialized Early Intervention services ( SEI ) for first episode psychosis are shown to be effective for the treatment of positive and negative symptoms , medication adherence , rates of relapse , substance abuse disorders , functional outcome and quality of life at two-year treatment follow up .
BACKGROUND	However , it is also reported that these benefits are not maintained when SEI is not sustained .
BACKGROUND	The objective of this trial is to test the efficacy of a 3-year extension of a SEI service ( following 2 years of SEI prior to randomization ) for the maintenance and consolidation of therapeutic gains as compared to regular care in the community .
METHODS	Following an initial 2 years of SEI , patients are randomized to receive either 3-years of continued SEI or regular care .
METHODS	SEI provided at three sites within the McGill network of SEI services , using a model of treatment comprised of : modified assertive case management ; psycho education for families ; multiple family intervention ; cognitive behavioural therapy ; and substance abuse treatment and monitoring .
METHODS	Blinded research assistants conduct ongoing evaluation of the outcome variables every three months .
METHODS	The primary outcome measure is remission status measured both as the proportion of patients in complete remission and the mean length of remission achieved following randomization during the additional three years of follow up .
METHODS	Based on preliminary data , it is determined that a total of 212 patients are needed to achieve adequate statistical power .
METHODS	Intent to treat with the last observation carried forward will be the primary method of statistical analysis .
CONCLUSIONS	The `` critical period '' hypothesis posits that there is a five year window during which the effects of the nascent psychotic illness can be countered and the impact of the disorder on symptomatic and functional outcomes can be offset through active and sustained treatment .
CONCLUSIONS	Providing SEI throughout this critical period may solidify the benefits of treatment such that gains may be more sustainable over time as compared to intervention delivered for a shorter period .
CONCLUSIONS	Findings from this study will have implications for service provision in first episode psychosis .
BACKGROUND	ISRCTN11889976 .

###25007060
OBJECTIVE	To assess the effectiveness of a child care center-based parent and teacher healthy lifestyle role-modeling program on child nutrition and physical activity outcomes .
METHODS	Child care centers ( N = 28 ) serving low-income families were randomized to intervention or control arms .
METHODS	Intervention centers ( N = 12 ) implemented ( 1 ) menu modifications , ( 2 ) a child 's healthy lifestyle curriculum , and ( 3 ) an adult ( teacher - and parent-focused ) healthy lifestyle role-modeling curriculum .
METHODS	Control centers ( N = 16 ) received an attention control safety curriculum .
METHODS	Nutrition and physical activity data were collected at the beginning ( T1 ) and at the end ( T2 ) of the school year .
METHODS	Exploratory factor analysis identified positive and negative nutrition and physical activity practices by children , parents , and teachers .
RESULTS	Intervention parents ' baseline ( = .52 , p < .0001 ) and school year consumption ( = .47 , p < .0001 ) of fruits/vegetables significantly increased their children 's consumption of fruits/vegetables from T1 to T2 .
RESULTS	Intervention parents significantly influenced a decrease in children 's junk food consumption ( = -.04 , p < .05 ) , whereas control parents significantly influenced an increase in their children 's junk food consumption ( = .60 , p < .001 ) from T1 to T2 .
RESULTS	Control children showed a significant increase in junk food consumption ( = .11 , p = .01 ) and sedentary behavior ( = .09 , p < .005 ) from T1 to T2 .
RESULTS	Teachers did not significantly influence preschool-age children 's nutrition or physical activity patterns from T1 to T2 .
CONCLUSIONS	Parent nutrition and physical activity patterns significantly influence their preschool-age children 's consumption of fruits/vegetables , junk food , and level of sedentary behavior .
CONCLUSIONS	Future obesity prevention intervention efforts targeting this age group should include parents as healthy lifestyle role models for their children .

###25794628
OBJECTIVE	Our objective was to compare the pain/stress levels of newborns among the 2 most common circumcision techniques after resident-wide education .
METHODS	The study period of this randomized control trial was October 2012 through March 2014 .
METHODS	Following informed consent , full-term males from uncomplicated singleton pregnancies were randomized to Gomco ( n = 137 ) or Mogen ( n = 137 ) devices .
METHODS	Resident-wide education for an obstetrics and gynecology residency program at a single institution was performed to ensure standardized training .
METHODS	All infants received a subcutaneous ring block before the procedure and oral sucrose intraoperatively .
METHODS	The primary outcome was neonatal pain assessed physiologically by salivary cortisol levels ( enzyme-linked immunosorbent assay ) and clinically by a validated neonatal pain score ( crying , requires increased oxygen administration , increased vital signs , expression , sleeplessness [ CRIES ] ) .
METHODS	Secondary outcomes were immediate complications , duration of procedure , and short-term outcomes as reported by mothers and pediatricians .
METHODS	A sample size of 274 ( accounting for 20 % loss of follow-up ) was determined sufficient to detect a mean difference of 1.22 g/dL in cortisol levels ( Gomco , SD3 .34 ; Mogen , SD0 .81 ) with 80 % power , P = .05 level of significance .
RESULTS	A total of 251 infants completed the protocol .
RESULTS	There were no significant differences in maternal or neonatal demographics including preoperative heart rate and mean arterial pressure .
RESULTS	In the Mogen circumcision , the percentage change of cortisol was significantly lower than Gomco ( 279.1498.15 vs 167.75272.22 ; P = .049 ) .
RESULTS	There were no differences in postoperative CRIES scores .
RESULTS	Postoperative heart rate was higher in infants undergoing Gomco circumcision than Mogen circumcision ( 138.716.5 vs 133.417.5 ; P = .015 ) as was mean arterial blood pressure ( 63.39.2 vs 60.48.6 ; P = .012 ) .
RESULTS	Mogen circumcisions were shorter ( 7.002.97 vs 3.651.84 minutes ; P < .001 ) .
RESULTS	There were no significant differences in bleeding complications .
RESULTS	A total of 168 maternal surveys were completed , with 98.7 % maternal satisfaction in Gomco vs 98.9 % in Mogen .
RESULTS	There were no reports of bleeding after discharge or circumcision revisions in either group to date .
CONCLUSIONS	Mogen clamp is associated with less neonatal pain physiologically by significantly lower percentage change in salivary cortisol , lower heart rate , and mean arterial blood pressure .
CONCLUSIONS	There was no difference in CRIES scores .
CONCLUSIONS	Mogen clamp circumcision duration is significantly shorter than Gomco clamp .
CONCLUSIONS	Both methods demonstrate satisfactory maternal and pediatrician short-term follow-up .

###25252696
OBJECTIVE	Remote ischaemic preconditioning ( RIPC ) , using brief cycles of limb ischaemia/reperfusion , is a non-invasive , low-cost intervention that may reduce perioperative myocardial injury ( PMI ) in patients undergoing cardiac surgery .
OBJECTIVE	We investigated whether RIPC can also improve short-term clinical outcomes .
METHODS	One hundred and eighty patients undergoing elective coronary artery bypass graft ( CABG ) surgery and/or valve surgery were randomised to receive either RIPC ( 2-5min cycles of simultaneous upper arm and thigh cuff inflation/deflation ; N = 90 ) or control ( uninflated cuffs placed on the upper arm and thigh ; N = 90 ) .
METHODS	The study primary end point was PMI , measured by 72h area under the curve ( AUC ) serum high-sensitive troponin-T ( hsTnT ) ; secondary end point included short-term clinical outcomes .
RESULTS	RIPC reduced PMI magnitude by 26 % ( -9.303 difference ( CI -15.618 to -2.987 ) 72h hsTnT-AUC ; p = 0.003 ) compared with control .
RESULTS	There was also evidence that RIPC reduced the incidence of postoperative atrial fibrillation by 54 % ( 11 % RIPC vs 24 % control ; p = 0.031 ) and decreased the incidence of acute kidney injury by 48 % ( 10.0 % RIPC vs 21.0 % control ; p = 0.063 ) , and intensive care unit stay by 1day ( 2.0 days RIPC ( CI 1.0 to 4.0 ) vs 3.0 days control ( CI 2.0 to 4.5 ) ; p = 0.043 ) .
RESULTS	In a post hoc analysis , we found that control patients administered intravenous glyceryl trinitrate ( GTN ) intraoperatively sustained 39 % less PMI compared with those not receiving GTN , and RIPC did not appear to reduce PMI in patients given GTN .
CONCLUSIONS	RIPC reduced the extent of PMI in patients undergoing CABG and/or valve surgery .
CONCLUSIONS	RIPC may also have beneficial effects on short-term clinical outcomes , although this will need to be confirmed in future studies .
BACKGROUND	ClinicalTrials.gov ID : NCT00397163 .

###25539658
BACKGROUND	Quality of life ( QoL ) is considered an important outcome in health research .
BACKGROUND	It can be rated by the patient , or by an external assessor .
BACKGROUND	We wished to identify the predictors of any discrepancies between these two approaches in people with schizophrenia .
METHODS	Patients with DSM schizophrenia and related disorders ( N = 80 ) completed both patient-rated ( Lancashire Quality of Life Profile ; LQOLP ) and assessor-rated ( Heinrich 's Quality of Life Scale ; QLS ) measures of QoL .
RESULTS	Patient-rated ( LQOLP ) and assessor-rated ( QLS ) measures showed a modest correlation ( r = 0.38 ) .
RESULTS	In a regression analysis , independent predictors of subjectively-rated QoL being higher than objectively-assessed QoL in the same patient , were low insight score ( BIS ) , negative symptoms ( PANSS ) , absence of depression ( CDSS ) , and less positive attitude toward prescribed treatment ( DAI ) .
CONCLUSIONS	In people with schizophrenia , scores on objectively - and subjectively-rated measures of quality of life can differ markedly .
CONCLUSIONS	When comparing subjective to objective assessments , patients with depressive symptoms will value their QoL lower , and those with low insight will value their QoL higher .
CONCLUSIONS	This has important implications for the utility and interpretation of QoL measures in schizophrenia .

###24521629
OBJECTIVE	Low serum levels of high density lipoprotein cholesterol ( HDL-C ) is an established risk factor for coronary heart disease ( CHD ) .
OBJECTIVE	Among a variety of lipid modifying drugs , the best single drug therapy to increase HDL-C levels , especially among high risk , isolated low HDL-C ( ILHDL-C ) cases is yet to be identified .
OBJECTIVE	The objectives of the present study were to evaluate the best pharmacological measure among atorvastatin , fenofibrate and niacin aimed to raise HDL-C and its effect in decreasing the estimated Framingham-10-year CHD risk percentage ( CHD-RP ) among high risk ILHDL-C cases in north India .
METHODS	Two hundred CHD equivalent ( CHD-RP20 ) , ILHDL-C cases were randomly assigned for treatment either with atorvastatin 10 mg/day ( n = 70 ) , micronized fenofibrate 160 mg/day ( n = 65 ) or niacin-extended release ( ER ) 750 mg/day ( n = 65 ) .
METHODS	After 6 wk of treatment , the dosages of drugs were doubled and the patients were finally assessed after 12 wk for their lipid values .
RESULTS	Baseline characteristics were similar in the three groups .
RESULTS	Niacin therapy 750 mg and 1.5 g/day resulted in a significant rise in HDL-C by 8.10 3.19 and 12.41 4.39 per cent ( P < 0.001 ) , respectively .
RESULTS	Fenofibrate 160 and 320 mg/day also resulted in a significant rise in HDL-C by 3.85 3.48 and 6.24 4.43 per cent ( P < 0.001 ) , respectively , while atorvastatin 10 and 20 mg/day resulted in a non-significant increase in HDL-C by 0.13 2.92 per cent and 0.51 2.63 per cent , respectively .
RESULTS	By increasing HDL-C values , niacin was found to be most effective in reduction of 10-year CHD-RP ( P < 0.001 ) , followed by fenofibrate ( P = 0.010 ) , while atorvastatin had no effect .
CONCLUSIONS	Our findings indicate that niacin rather than fibrates or statins seems to provide a safe and effective therapy for increasing HDL-C , thus reducing the cumulative CHD risk among ILHDL-C cases .

###24521775
BACKGROUND	Calcineurin inhibitors ( CNIs ) are essential immunosuppressive drugs after renal transplantation .
BACKGROUND	Because of nephrotoxicity , withdrawal has been a challenge since their introduction .
METHODS	A randomized multicenter trial included 212 kidney patients transplanted between 1997 and 1999 .
METHODS	All patients were initially treated with mycophenolate mofetil ( MMF ) , cyclosporine A ( CsA ) , and prednisone ( pred ) .
METHODS	At 6 months after transplantation , 63 patients were randomized for MMF/pred , 76 for MMF/CsA , and 73 for MMF/CsA/pred .
METHODS	Within 18 months after randomization 23 patients experienced a rejection episode : MMF/pred ( 27.0 % ) , MMF/CsA ( 6.8 % ) and MMF/CsA/pred ( 1.4 % ) ( P < 0.001 ) .
RESULTS	During 15 years of follow-up , 73 patients died with a functioning graft , and 43 patients lost their graft .
RESULTS	Ninety-six were alive with a functioning graft .
RESULTS	Intention-to-treat analysis did not show a significant difference in patient and graft survival .
RESULTS	In multivariate analysis , death-censored graft survival was significantly associated with serum creatinine at 6 months after transplantation and maximum PRA but not with the randomization group .
RESULTS	CNI withdrawal did not result in a reduced incidence of or death by malignancy or cardiovascular disease .
RESULTS	Death-censored graft survival was significantly worse in those patients randomized for CNI withdrawal that had to be reverted to CNI .
RESULTS	Independent of randomization group , compared with no rejection , death-censored graft survival was significantly worse in 23 patients with acute rejection after randomization .
CONCLUSIONS	Fifteen years after conversion to a CNI free regimen , there was no benefit regarding graft and patient survival or regarding prevalence of or death by comorbidities .
CONCLUSIONS	However , rejection shortly after CNI withdrawal was associated with decreased graft survival .

###25635577
OBJECTIVE	To report the safety of intravitreal ocriplasmin injection based on 2 Phase 3 clinical trials in patients with symptomatic vitreomacular adhesion/vitreomacular traction , including when associated with full-thickness macular holes .
METHODS	Safety analyses were based on 2 completed Phase 3 studies assessing intravitreal ocriplasmin injection .
METHODS	Adverse events ( AEs ) , serious AEs , and suspected adverse drug reactions are reported .
METHODS	The authors also report AEs of special interest from 8 other completed Phase 2 studies and 2 ongoing studies .
RESULTS	A total of 465 eyes were injected with ocriplasmin ( 125 g ) , and 187 eyes were treated with placebo injection in Phase 3 studies .
RESULTS	Overall AE rate was 69.0 % in the placebo group and 76.6 % for ocriplasmin-treated patients .
RESULTS	Most AEs were in the study eye , mild or moderate in severity , and transient .
RESULTS	All suspected adverse drug reactions were ocular ; the majority was nonserious , of mild intensity , and transient .
CONCLUSIONS	Intravitreal ocriplasmin injection provides a generally well-tolerated pharmacologic treatment option for patients with symptomatic vitreomacular adhesion/vitreomacular traction , including when associated with full-thickness macular holes 400 m in diameter .

###25511452
BACKGROUND	The majority of mid-life and older adults in the UK are not achieving recommended physical activity levels and inactivity is associated with many health problems .
BACKGROUND	Walking is a safe , appropriate exercise .
BACKGROUND	The PACE-UP trial sought to increase walking through the structured use of a pedometer and handbook , with and without support from a practice nurse trained in behaviour change techniques ( BCTs ) .
BACKGROUND	Understanding barriers and facilitators to engagement with a primary care based physical activity intervention is essential for future trials and programmes .
METHODS	We conducted semi-structured telephone interviews using a topic guide with purposive samples of participants who did and did not increase their walking from both intervention groups .
METHODS	Interviews were audio-recorded , transcribed and coded independently by researchers prior to performing a thematic analysis .
METHODS	Responsiveness to the specific BCTs used was also analysed .
RESULTS	Forty-three trial participants were interviewed in early 2014 .
RESULTS	Almost all felt they had benefitted , irrespective of their change in step-count , and that primary care was an appropriate setting.Important facilitators included a desire for a healthy lifestyle , improved physical health , enjoyment of walking in the local environment , having a flexible routine allowing for an increase in walking , appropriate self and external monitoring and support from others.Important barriers included physical health problems , an inflexible routine , work and other commitments , the weather and a mistrust of the monitoring equipment.BCTs that were reported to have the most impact included : providing information about behaviour-health link ; prompting self-monitoring and review of goals and outcomes ; providing feedback ; providing specific information about how to increase walking ; planning social support/change ; and relapse prevention .
RESULTS	Rewards were unhelpful .
CONCLUSIONS	Despite our expectation that there would be a difference between the experiences of those who did and did not objectively increase their walking , we found that most participants considered themselves to have succeeded in the trial and benefitted from taking part .
CONCLUSIONS	Barriers and facilitators were similar across demographic groups and trial outcomes .
CONCLUSIONS	Findings indicated several BCTs on which PA trial and programme planners could focus efforts with the expectation of greatest impact as well as strong support for primary care as an appropriate venue .
BACKGROUND	ISRCTN98538934 .

###24907879
OBJECTIVE	this study investigated the influence of anatomical predictors on difficult laryngoscopy and orotracheal intubation in obese patients by comparing Macintosh and Airtraq laryngoscopes .
METHODS	from 132 bariatric surgery patients ( body mass index 35 kgm ( -1 ) ) , cervical perimeter , sternomental distance , interincisor distance , and Mallampati score were recorded .
METHODS	The patients were randomized into two groups according to whether a Macintosh ( n = 64 ) or an Airtraq ( n = 68 ) laryngoscope was used for tracheal intubation .
METHODS	Time required for intubation was the first outcome .
METHODS	Cormack-Lehane score , number of intubation attempts , the Macintosh blade used , any need for external tracheal compression or the use of gum elastic bougie were recorded .
METHODS	Intubation failure and strategies adopted were also registered .
RESULTS	intubation failed in two patients in the Macintosh laryngoscope group , and these patients were included as worst cases scenario .
RESULTS	The intubation times were 36.9 +22.8 s and 13.7 +3.1 s for the Macintosh and Airtraq laryngoscope groups ( p < 0.01 ) , respectively .
RESULTS	Cormack-Lehane scores were also lower for the Airtraq group .
RESULTS	One patient in the Macintosh group with intubation failure was quickly intubated with the Airtraq .
RESULTS	Cervical circumference ( p < 0.01 ) and interincisor distance ( p < 0.05 ) influenced the time required for intubation in the Macintosh group but not in the Airtraq group .
CONCLUSIONS	in obese patients despite increased neck circumference and limited mouth opening , the Airtraq laryngoscope affords faster tracheal intubation than the Macintosh laryngoscope , and it may serve as an alternative when conventional laryngoscopy fails .

###24859440
OBJECTIVE	In this prospective trial we compared ultralow dose computerized tomography reconstruction algorithms and routine low dose computerized tomography for detecting urolithiasis .
METHODS	A total of 48 consenting adults prospectively underwent routine low dose noncontrast computerized tomography immediately followed by an ultralow dose series targeted at a 70 % to 90 % reduction from the routine low dose technique ( sub mSv range ) .
METHODS	Ultralow dose series were reconstructed with filtered back projection , and adaptive statistical and model based iterative reconstruction techniques .
METHODS	Transverse ( axial ) and coronal images were sequentially reviewed by 3 relatively inexperienced trainees , including a radiology resident , a urology fellow and an abdominal imaging fellow .
METHODS	Three experienced abdominal radiologists independently reviewed the routine low dose filtered back projection images , which served as the reference standard .
RESULTS	The mean effective dose for the ultralow dose scans was 0.91 mSv ( median 0.82 ) , representing a mean SD 78 % 5 % decrease compared to the routine low dose .
RESULTS	Overall sensitivity and positive predictive value per stone for ultralow dose computerized tomography at a 4 mm threshold was 0.91 and 0.98 , respectively .
RESULTS	Sensitivity , specificity , positive and negative predictive values , and accuracy per patient were 0.87 , 1.00 , 1.00 , 0.94 and 0.96 , respectively .
RESULTS	At a 4 mm threshold the sensitivity and positive predictive value per stone of the ultralow dose series for filtered back projection , and adaptive statistical and model based iterative reconstruction was 0.89 and 0.96 , 0.91 and 0.98 , and 0.93 and 1.00 , respectively .
RESULTS	Sensitivity , specificity , positive and negative predictive values , and accuracy per patient at the 4 mm threshold were 0.82 , 1.00 , 1.00 , 0.91 and 0.94 for filtered back projection , 0.85 , 1.00 , 1.00 , 0.93 and 0.95 for adaptive statistical iterative reconstruction , and 0.94 , 1.00 , 1.00 , 0.97 and 0.98 for model based iterative reconstruction , respectively .
RESULTS	Sequential review of coronal images changed the final stone reading in 13 % of cases and improved diagnostic confidence in 49 % .
CONCLUSIONS	At a 4 mm renal calculus size threshold ultralow dose computerized tomography is accurate for detection when referenced against routine low dose series with dose reduction to below the level of a typical 2-view plain x-ray ofthekidneys , ureters and bladder .
CONCLUSIONS	Slight differences were seen among the reconstruction algorithms .
CONCLUSIONS	There was mild improvement with model based iterative reconstruction over filtered back projection and adaptive statistical iterative reconstruction .
CONCLUSIONS	Coronal images improved detection and diagnostic confidence over axial images alone .

###24458543
OBJECTIVE	This secondary analysis of data from a randomised controlled trial explores associations between common symptom clusters and evaluates pre-treatment to post-treatment changes in clinical levels of these symptoms following cognitive behaviour therapy for insomnia ( CBT-I ) .
METHODS	Baseline data from 113 participants with insomnia were explored to establish rates of and associations between clinical levels of fatigue , anxiety and depression across the sample .
METHODS	Effects of CBT-I on this symptom cluster were also explored by examining changes in pre-treatment to post-treatment levels of fatigue , anxiety and depression .
RESULTS	At baseline , the most common symptom presentation was insomnia + fatigue , and 30 % of the sample reported at least three co-morbid symptoms .
RESULTS	Post-CBT , the number of those experiencing clinical insomnia and clinical fatigue decreased .
RESULTS	There were no changes in anxiety rates from baseline to post-treatment in the CBT group and modest reductions in rates of those with clinical depression .
RESULTS	Seven individuals ( 9.6 % ) from the CBT group were completely symptom free at post-treatment compared with 0 % from the treatment as usual condition .
RESULTS	Chi-square analysis revealed a significant relationship between group allocation and changes in symptoms of insomnia and fatigue .
RESULTS	No such relationship was found between group allocation and mood variables .
CONCLUSIONS	These findings confirm the high rate of symptom co-morbidities among cancer patients and highlight strong associations between sleep and fatigue .
CONCLUSIONS	CBT-I appears to offer generalised benefit to the symptom cluster as a whole and , specifically , is effective in reducing fatigue , which exceeded clinical cut-offs prior to implementation of the intervention .
CONCLUSIONS	This has implications for the diagnosis/management of common symptoms in cancer patients .

###24912844
BACKGROUND	Approximately one third of 10-11 year olds in England are now overweight or obese suggesting that population approaches are urgently required .
BACKGROUND	However , despite the increasing number of school-based interventions to prevent obesity , results continue to be inconsistent and it is still unclear what the necessary conditions are that lead to the sustained behaviour change required to affect weight status .
BACKGROUND	The Healthy Lifestyles Programme is a theoretically informed four phase multi-component intervention which seeks to create supportive school and home environments for healthy behaviours .
METHODS	A process evaluation has run alongside the exploratory trial of the Healthy Lifestyles Programme to ascertain the feasibility and acceptability of ; the trial design ( including the trial outcomes ) and the HeLP Programme and whether it is able to engage schools , children and their families .
METHODS	Data was collected using interviews with teachers ( n = 12 ) and parents ( n = 17 ) and six focus groups with children ( n = 47 ) and a questionnaire for parents of children in the intervention schools .
METHODS	Interview and focus group data relating to the intervention was analysed using framework analysis .
RESULTS	Four schools and 201 children participated in the exploratory trial .
RESULTS	The data showed that the trial design was feasible and acceptable for schools and children .
RESULTS	Three themes emerged for the data in relation to the acceptability and feasibility of the HeLP Programme ( value , compatibility with the curriculum and enjoyment ) and two themes emerged in relation to engagement ( ` knowledge and awareness ' and ` taking messages on board ' ) .
RESULTS	The latter could be broken down into 4 subthemes ( ` initiating discussion with family and friends ' , ` acceptance of family rules ' , ` increased responsibility ' and ` the importance of the mode and agent of delivery ' ) .
RESULTS	The use of highly inclusive and interactive delivery methods where the children were encouraged to identify with and take ownership of the healthy lifestyle messages were identified as important factors in motivating the children to take the messages home , seek parental support and initiate family lifestyle behaviour change .
CONCLUSIONS	The process evaluation of the exploratory trial has not only provided evidence of the feasibility and acceptability of the Programme , it has also allowed an understanding of how HeLP engages schools , children and their families .
CONCLUSIONS	These findings have informed the process evaluation for the definitive trial .

###24683779
OBJECTIVE	The aim of this study was to evaluate the shear bond strength to dentin of primary molars of a new self-adhering flowable resin composite with two ionomer-based cements and one flowable resin composite in combination with two different adhesive systems .
METHODS	Fifty primary molars were grinded on the occlusal surface to obtain flat dentin substrate and randomly divided into 5 groups ( n = 10 ) : OFL : Phosphoric Acid/Optibond FL/Premise Flow ; OAO : Optibond All-In-One/Premise Flowable ; II : Polyacrylic Acid/Fuji II ; IX : Polyacrylic Acid/Fuji IX ; V : Vertise Flow .
METHODS	Cylinders ( 3mm diameter - 5mm height ) of restorative material were built-up in three increments over the dentin surfaces .
METHODS	A shear load was applied until failure .
METHODS	Bond strength values were statistically analysed with Kruskall-Wallis ANOVA followed by Dunn 's test ( P < .05 ) .
METHODS	Differences in failure mode distribution were assessed with Chi-square ( P < .05 ) .
RESULTS	OFL and OAO recorded significantly higher bond strengths than the other groups .
RESULTS	Adhesive failures were evident in all groups except OFL and OAO , in which also cohesive failures in dentin were observed .
CONCLUSIONS	Vertise Flow established on primary dentin bond strengths values similar to those of glass ionomer cements routinely used for restorations of primary teeth .
CONCLUSIONS	The combination of flowable resin with etch-and-rinse or all-in-one adhesives obtained higher bond strength values , thus involving a more complex handling .

###25403646
BACKGROUND	Clinical trials in heart failure have focused on the improvement in symptoms or decreases in the risk of death and other cardiovascular events .
BACKGROUND	Little is known about the effect of drugs on the risk of clinical deterioration in surviving patients .
RESULTS	We compared the angiotensin-neprilysin inhibitor LCZ696 ( 400 mg daily ) with the angiotensin-converting enzyme inhibitor enalapril ( 20 mg daily ) in 8399 patients with heart failure and reduced ejection fraction in a double-blind trial .
RESULTS	The analyses focused on prespecified measures of nonfatal clinical deterioration .
RESULTS	In comparison with the enalapril group , fewer LCZ696-treated patients required intensification of medical treatment for heart failure ( 520 versus 604 ; hazard ratio , 0.84 ; 95 % confidence interval , 0.74-0 .94 ; P = 0.003 ) or an emergency department visit for worsening heart failure ( hazard ratio , 0.66 ; 95 % confidence interval , 0.52-0 .85 ; P = 0.001 ) .
RESULTS	The patients in the LCZ696 group had 23 % fewer hospitalizations for worsening heart failure ( 851 versus 1079 ; P < 0.001 ) and were less likely to require intensive care ( 768 versus 879 ; 18 % rate reduction , P = 0.005 ) , to receive intravenous positive inotropic agents ( 31 % risk reduction , P < 0.001 ) , and to have implantation of a heart failure device or cardiac transplantation ( 22 % risk reduction , P = 0.07 ) .
RESULTS	The reduction in heart failure hospitalization with LCZ696 was evident within the first 30 days after randomization .
RESULTS	Worsening of symptom scores in surviving patients was consistently more common in the enalapril group .
RESULTS	LCZ696 led to an early and sustained reduction in biomarkers of myocardial wall stress and injury ( N-terminal pro-B-type natriuretic peptide and troponin ) versus enalapril .
CONCLUSIONS	Angiotensin-neprilysin inhibition prevents the clinical progression of surviving patients with heart failure more effectively than angiotensin-converting enzyme inhibition .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01035255 .

###24986373
BACKGROUND	Acute kidney injury ( AKI ) is observed in up to 41 % of patients undergoing transcatheter aortic valve implantation ( TAVI ) and is associated with increased risk for mortality .
BACKGROUND	The aim of the present study is to evaluate whether furosemide-induced diuresis with matched isotonic intravenous hydration using the RenalGuard system reduces AKI in patients undergoing TAVI .
METHODS	Reduce-AKI is a randomized sham-controlled study designed to examine the effect of an automated matched hydration system in the prevention of AKI in patients undergoing TAVI .
METHODS	Patients will be randomized in a 1:1 fashion to the RenalGuard system ( active group ) versus non-matched saline infusion ( sham-controlled group ) .
METHODS	Both arms receive standard overnight saline infusion and N-acetyl cysteine before the procedure .
CONCLUSIONS	The Reduce-AKI trial will investigate whether the use of automated forced diuresis with matched saline infusion is an effective therapeutic tool to reduce the occurrence of AKI in patients undergoing TAVI .
BACKGROUND	Clinicaltrials.gov : NCT01866800 , 30 April 30 2013 .

###24762684
OBJECTIVE	To compare the efficacies of non-bismuth quadruple therapy for 7 days versus standard triple therapy for 7 or 10 days in initial treatment of Helicobacter pylori ( H.pylori ) .
METHODS	A randomized , open-labeled , controlled trial comparing non-bismuth quadruple therapy with standard triple therapy was performed at Peking University First Hospital from August 2010 to July 2012 .
METHODS	A total of 246 patients with a diagnosis of H.pylori infection by ( 13 ) C-urea breath test and receiving no eradication therapy were randomly divided into non-bismuth quadruple therapy and standard triple therapy for 7 or 10 days .
METHODS	There were 110 males and 136 females with an age range of 18-75 years .
METHODS	Among them , 81 patients received non-bismuth quadruple therapy ( esomeprazole 20 mg , amoxicillin 1 000 mg , clarithromycin 500 mg and tinidazole 500 mg given twice daily for 7 days ) ; 82 standard triple therapy ( esomeprazole 20 mg , amoxicillin 1 000 mg and clarithromycin 500 mg given twice daily ) for 7 days and 83 standard triple therapy for 10 days .
METHODS	The efficacies were examined at Week 4 post-therapy by ( 13 ) C-urea breath test .
METHODS	The incidence of adverse drug reactions was recorded .
RESULTS	Among them , 242 patients completed the follow-up .
RESULTS	The eradication rates for non-bismuth quadruple therapy and standard triple therapy for 7 or 10 days were 91.4 % ( 74/81 ) , 79.3 % ( 65/82 ) and 79.5 % ( 66/83 ) as determined by intention-to-treat analysis ( ITT ) .
RESULTS	The eradication rates were 92.5 % ( 74/80 ) , 81.3 % ( 65/80 ) and 80.5 % ( 66/82 ) respectively as determined by per-protocol analysis ( PP ) .
RESULTS	Non-bismuth quadruple therapy was superior to standard triple therapy for 7 days ( ITT analysis P = 0.029 , PP analysis P = 0.035 ) and 10 days ( ITT analysis P = 0.032 , PP analysis P = 0.026 ) .
RESULTS	The differences for the eradication rates between standard triple therapy for 7 days and for 10 days were insignificant ( ITT analysis P = 0.968 , PP analysis P = 0.902 ) : Adverse reaction rates for non-bismuth quadruple therapy ( 8.8 % , 7/80 ) and standard triple therapy for 7 days ( 7.5 % , 6/80 ) and 10 days ( 9.8 % , 8/82 ) were not significantly different ( P = 0.872 ) .
CONCLUSIONS	Non-bismuth quadruple therapy for 7 days is both effective and safe for the first-line eradication of H.pylori .

###25523054
OBJECTIVE	The Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke-Enhanced Regimen ( CLEAR-ER ) trial demonstrated safety of recombinant tissue-type plasminogen activator ( r-tPA ) plus eptifibatide in acute ischemic stroke ( AIS ) .
OBJECTIVE	CLEAR-ER randomized AIS patients ( 5:1 ) to 0.6 mg/kg r-tPA plus eptifibatide versus standard r-tPA ( 0.9 mg/kg ) .
OBJECTIVE	Interventional Management of Stroke III randomized AIS patients to r-tPA plus endovascular therapy versus standard r-tPA .
OBJECTIVE	Albumin in Acute Stroke Part 2 randomized patients to albuminr-tPA versus saliner-tPA .
OBJECTIVE	Our aim was to compare outcomes in CLEAR-ER combination arm patients to propensity score-matched r-tPA only subjects in Albumin in Acute Stroke Part 2 and Interventional Management of Stroke III .
METHODS	The primary outcome was 90-day severity-adjusted modified Rankin score ( mRS ) dichotomization based on baseline National Institutes of Health Stroke Scale .
METHODS	Secondary outcomes were 90-day mRS dichotomization as excellent ( mRS , 0-1 ) ; mRS dichotomization as favorable ( mRS , 0-2 ) ; and nonparametric analysis of the ordinal mRS.
RESULTS	Eighty-five combination arm CLEAR-ER subjects were matched with 169 Albumin in Acute Stroke Part 2 and Interventional Management of Stroke III trials ' r-tPA only patients ( controls ) .
RESULTS	Median age in CLEAR-ER and control subjects was 68years ; median National Institutes of Health Stroke Scale in the CLEAR-ER subjects was 11 and in control subjects 12 .
RESULTS	At 90 days , CLEAR-ER subjects had a nonsignificantly greater proportion of patients with favorable outcomes ( 45 % versus 36 % ; unadjusted relative risks , 1.24 ; 95 % confidence intervals , 0.91-1 .69 ; P = 0.18 ) .
RESULTS	Secondary outcomes were 52 % versus 34 % excellent outcomes ( relative risks , 1.51 ; 95 % confidence intervals , 1.13-2 .02 ; P = 0.007 ) ; 60 % versus 53 % favorable outcome ( relative risks , 1.13 ; 95 % confidence intervals , 0.90-1 .41 ; P = 0.31 ) ; and ordinal Cochran-Mantel-Haenszel P = 0.10 .
CONCLUSIONS	r-tPA plus eptifibatide showed a favorable direction of effect that was consistent across multiple approaches for AIS outcome evaluation .
CONCLUSIONS	A phase III trial to establish the efficacy of r-tPA plus eptifibatide for improving AIS outcomes is warranted .

###26027223
METHODS	A randomized prospective study .
METHODS	The study included 87 children aged from 5 to 18 , ASA I-II .
METHODS	The patients were divided into two groups .
METHODS	We assessed the impact of reamberin 1.5 % ( succinate-containing infusion solution ) on the level of metabolism and recovery after surgery in patients of main group ( n = 44 ) and control group ( n = 43 ) during different surgeries .
METHODS	All patients received general anaesthesia with sevoflurane , fentanyl , and rocuronium .
RESULTS	Reamberin 1.5 % promotes to increase the level of basal metabolism in the early postoperative period , decreases the duration of awakening periods , improves recovery of motor activity and adequate breathing .

###24331115
OBJECTIVE	It is difficult to choose the correct fertility treatment in women with poor ovarian reserve .
OBJECTIVE	Although various methods have been used , the management of controlled ovarian hyperstimulation is not easy in poor responders .
OBJECTIVE	The aim of this study was to evaluate the efficacy of dehydroepiandrosterone ( DHEA ) on in vitro fertilization-intracytoplasmic sperm injection ( IVF-ICSI ) outcome of poor responders .
METHODS	This was a randomized , prospective controlled trial .
METHODS	Women with serum antimullerian hormone < 1 ng/ml or serum follicle-stimulating hormone > 15 IU/l and antral follicle count < 4 on day 2 of the menstrual cycle were considered to have poor ovarian reserve .
METHODS	All women were treated with a microdose induction protocol .
METHODS	Women in the study group received IVF-ICSI and DHEA 75 mg daily for 12 weeks .
METHODS	Women in the control group received IVF-ICSI without DHEA supplementation .
RESULTS	In total , 208 women with diminished ovarian reserve was enrolled in the study , 104 in the study group and 104 in the control group .
RESULTS	The number of oocytes retrieved and the fertilization rate were slightly higher in the study group , but the pregnancy rate was higher in the control group .
RESULTS	The differences were not significant .
CONCLUSIONS	The results failed to show that DHEA supplementation enhances IVF-ICSI outcome in women with poor ovarian reserve .

###25616941
BACKGROUND	Ischemic preconditioning ( IPC ) and anesthetic preconditioning ( APC ) have been reported to attenuate ischemia-reperfusion ( IR ) injury after liver resection under continuous inflow occlusion .
BACKGROUND	This study evaluates whether these strategies enhance hepatic protection of remnant liver against IR after liver resection with intermittent clamping ( INT ) .
METHODS	A total of 106 patients without underlying liver disease and submitted to liver resection using INT were randomized into 3 groups : IPC ( 10 minutes of inflow occlusion followed by 10 minutes of reperfusion before liver transection ) , APC ( sevoflurane administration for 20 minutes before liver transection ) , and INT ( no preconditioning ) .
METHODS	Patients were also stratified according to the extent of the hepatectomy .
METHODS	Cytoprotection was evaluated by comparing hepatocyte and endothelial dysfunction markers , apoptosis , histologic lesions , and postoperative outcome .
RESULTS	No differences were observed in preoperative chemotherapy and steatosis , total warm ischemia time , operative time , or blood loss .
RESULTS	Kinetics of transaminases ( aspartate aminotransferase , P = .137 ; alanine aminotransferase , P = .616 ) , bilirubin ( P = .980 ) , and hyaluronic acid increase ( P = .514 ) revealed no differences .
RESULTS	Significant apoptosis was present in 40 % of patients , mild-to-moderate leukocyte infiltration and steatosis in 45 % and 55 % , respectively , and mild sinusoidal congestion in 65 % , with a similar distribution in the 3 groups .
RESULTS	When patients were stratified by major versus minor resections , no differences were observed in any of the variables studied .
RESULTS	Postoperative clinical outcomes were also similar .
CONCLUSIONS	These results suggest that these protocols of IPC and APC used in this study do not provide better cytoprotection from IR when INT is used .

###25475947
OBJECTIVE	The effects of the use of the stapler or hand-sewn method in oesophagogastric anastomosis on postoperative morbidity , mortality and quality of life after oesophagectomy remain controversial .
OBJECTIVE	The purpose of his study was to compare clinical outcomes of hand-sewn and stapler techniques in oesophagogastric anastomosis after oesophagectomy for oesophageal carcinoma .
METHODS	We performed a prospective randomized controlled trial on 478 patients treated for oesophageal tumour between February 2009 and December 2011 .
METHODS	Patients were randomly assigned to two treatment groups with 237 patients in the hand-sewn group and 241 patients in the circular stapler group ( http://www.chictr.org: ChiCTR-TRC-13004428 ) .
RESULTS	The mean follow-up time was 18 months .
RESULTS	The mean operating time of the stapled group and the hand-sewn group were 193 and 226 min , respectively ( P < 0.001 ) .
RESULTS	Seventeen clinical and radiological leakages occurred in the hand-sewn group compared with 7 in the stapler group ( P = 0.033 ) .
RESULTS	In the stapler group hospital mortality occurred in 10 patients ( 4.3 % ) and in the hand-sewn group in 9 patients ( 3.9 % ) ( P = 0.837 ) .
RESULTS	Anastomotic strictures were noted in 31 patients from the stapler group ( 14.2 % ) and in 16 patients from the hand-sewn group ( 7.5 % ) ( P = 0.027 ) .
CONCLUSIONS	Using the circular stapler method in oesophagogastric anastomoses had a lower anastomotic leakage rate and shorter operating time compared with the hand-sewn method .
CONCLUSIONS	However , the circular stapler method was associated with a significantly increased risk of anastomotic strictures .

###24593170
OBJECTIVE	To evaluate the long-term efficacy and safety of certolizumab pegol ( CZP ) plus methotrexate treatment and to assess the efficacy of two CZP maintenance dosing schedules in Japanese rheumatoid arthritis ( RA ) patients with an inadequate response to methotrexate .
METHODS	J-RAPID double-blind patients were entered into an open-label extension ( OLE ) study .
METHODS	Patients withdrawn due to lack of efficacy at 16 weeks and double-blind completers without a week-24 American College of Rheumatology ( ACR ) 20 response received CZP 200 mg every other week ( Q2W ) plus methotrexate .
METHODS	Double-blind completers with week-24 ACR20 responses were randomized to CZP 200 mg Q2W plus methotrexate or CZP 400 mg every 4 weeks plus methotrexate .
RESULTS	The ACR20/ACR50/ACR70 response rates of double-blind completers ( n = 204 ) were 89.7 % / 67.2 % / 36.3 % at OLE entry and 95.6 % / 84.8 % / 58.3 % at 52 weeks , respectively .
RESULTS	Other clinical , functional and radiographic outcomes were sustained with long-term CZP plus methotrexate .
RESULTS	Long-term treatment with CZP was well-tolerated with no new unexpected adverse events observed .
RESULTS	The efficacy and safety of CZP treatment were similar between the two dosing schedules .
CONCLUSIONS	Continued CZP administration with methotrexate maintained efficacy over 52 weeks and was well-tolerated for Japanese RA patients .
CONCLUSIONS	No obvious differences in clinical efficacy and safety were observed between the two dosing schedules , giving flexibility in maintenance administration schedules .

###24494295
OBJECTIVE	To explore the efficacy of electric acupoint stimulation on shivering in cesarean section .
METHODS	Eighty cases of parturients , under the America Society of Anesthesiologists ( ASA ) physical status II , were randomized into a transcutaneous electrical acupoint stimulation ( TEAS ) assisted anesthesia group ( group A ) and an anesthesia group ( group B ) .
METHODS	Spinal-epidural anesthesia ( CSEA ) puncture was applied to both groups and 8 mg of 0.75 % bubivacaine was given by spinal injection , the block level was T4 T8 .
METHODS	In group A , TEAS was applied before CSEA at paired acupoints-ipsilateral Hegu ( LI 4 ) - Laogong ( PC 8 ) and Sanyinjiao ( SP 6 ) - Zusanli ( ST 36 ) till ending the surgery .
METHODS	The 4 pair of bilateral acupoints were fixed with self-adhesive electrodes and connected with Han 's acupoint and nerve stimulator ( HANS , LH402H ) , the frequency was 2 Hz / 15 Hz , the intensity was 10 - 30 mA and the form was densedisperse wave within the patients ' tolarance .
METHODS	The heart rate ( HR ) , mean arterial pressure ( MAP ) , oxyhemoglobin saturation ( SPO ) and shivering degree were recorded before anesthesia ( To ) , 1 min after anesthesia puncture ( Ti ) , 1 min after the delivery ( Tz ) , during abdomen closure ( T3 ) and at the end of surgery ( T4 ) .
RESULTS	The occurrence rate of shivering was 35.0 % ( 14/40 ) in group A , which was lower to 67.5 % ( 27/40 , P < 0.05 ) in group B ; the degree of shivering was lighter in group A than that in group B at T2 , T3 and T4 ( all P < 0.01 ) .
RESULTS	In group A , HR was faster at T1 and T2 compared to that at To ( all P < 0.05 ) , while at T3 and T4 , the HR was the same with that before anesthesia ( all P > 0.05 ) .
RESULTS	In group B , the HR was faster at T1 , T2 , T3 and T4 compared to that at T0 ( P < 0.05 , P < 0.01 ) .
RESULTS	In both groups , the MAP was lower at T1 , T2 ( P < 0.05 , P < 0.01 ) and resumed to that before anesthesia at T3 and T4 ( all P > 0.05 ) ; there was no statistical significance of SPO2 in both groups ( all P > 0.05 ) .
CONCLUSIONS	TEAS can reduce the occurrence rate of shivering and steady the heart rate in cesarean section .

###24633858
BACKGROUND	There is increasing recognition of the potential use of reminiscence in maintaining or improving the quality of life of people with dementia .
BACKGROUND	Despite being used widely in dementia care , evidence on the effectiveness of reminiscence remains uncertain .
OBJECTIVE	This study aims to evaluate the effectiveness of a structured education-based reminiscence programme-the Dementia Education Programme Incorporating Reminiscence for Staff-for people with dementia residing in long-stay care settings in Ireland .
METHODS	Dementia Education Programme Incorporating Reminiscence for Staff is a two-group , single-blind , cluster randomised trial conducted in long-stay residential care settings in Ireland .
METHODS	The primary outcome was the self-rated quality of life of residents as measured by the Quality of Life-Alzheimer 's Disease instrument .
RESULTS	Using an intention-to-treat analysis , we found that the estimated effect of the intervention on the quality of life of residents was a non-significant 3.54 ( p = 0.1 ; 95 % confidence interval -0.83 , 7.90 ) , expressed as the difference in mean improvement between the intervention and control groups .
RESULTS	However , the per-protocol analysis yielded a significant effect for the intervention on the quality of life of residents of 5.22 ( p = 0.04 ; 95 % confidence interval 0.11 , 10.34 ) .
CONCLUSIONS	Reminiscence may , in certain circumstances , be an effective care option for people with dementia in long-stay settings with potential to impact positively on the quality of life of residents .

###25487899
BACKGROUND	Infection after shoulder surgery can have devastating consequences .
BACKGROUND	Recent literature has implicated Propionibacterium acnes as a causative agent for postoperative shoulder infections .
BACKGROUND	Axillary hair removal has been suggested as a method for infection prevention , although data quantifying its effect on the bacterial load around the shoulder are lacking .
METHODS	We clipped one randomly selected axilla in 85 healthy male volunteers with commercially available surgical clippers .
METHODS	Aerobic and anaerobic culture specimens were taken from the clipped and unclipped axillae .
METHODS	Each shoulder was then prepared with 2 % chlorhexidine gluconate and 70 % isopropyl alcohol .
METHODS	Repeated culture specimens were then taken from both axillae .
METHODS	Cultures were held for 14days and recorded with a semiquantitative system ( 0-4 points ) .
METHODS	Results were compared by the Wilcoxon signed rank test .
RESULTS	There was no difference in the burden of P. acnes between the clipped and unclipped axillae before or after surgical preparation ( P = .109 , P = .344 , respectively ) .
RESULTS	There was a significantly greater bacterial burden in the clipped shoulder compared with the unclipped shoulder before preparation ( P < .001 ) but not after preparation ( P = .285 ) .
RESULTS	There was a significant reduction in total bacterial load and P. acnes load for both axillae after surgical preparation ( P < .001 for all ) .
CONCLUSIONS	Removal of axillary hair has no effect on the burden of P. acnes in the axilla .
CONCLUSIONS	Clipped axillae had a higher total bacterial burden .
CONCLUSIONS	A 2 % chlorhexidine gluconate surgical preparation is effective at removal of all bacteria and specifically P. acnes from the axilla .

###25004186
OBJECTIVE	Major depressive disorder ( MDD ) is one of the most common psychiatric disorders , conferring considerable individual , family , and community burden .
OBJECTIVE	To date , treatments for MDD have been derived from the monoamine hypothesis , and there is a paucity of emerging antidepressants , especially with novel mechanisms of action and treatment targets .
OBJECTIVE	N-acetylcysteine ( NAC ) is a redox-active glutathione precursor that decreases inflammatory cytokines , modulates glutamate , promotes neurogenesis , and decreases apoptosis , all of which contribute to the neurobiology of depression .
METHODS	Participants with a current episode of MDD diagnosed according to DSM-IV-TR criteria ( N = 252 ) were treated with NAC or placebo in addition to treatment as usual for 12 weeks and were followed to 16 weeks .
METHODS	Data were collected between 2007 and 2011 .
RESULTS	The omnibus interaction between group and visit for the Montgomery-Asberg Depression Rating Scale ( MADRS ) , the primary outcome measure , was not significant ( F , .
RESULTS	= 1.98 , P = .067 ) , and the groups did not separate at week 12 ( t. = -1.12 , P = .265 ) .
RESULTS	However , at week 12 , the scores on the Longitudinal Interval Follow-Up Evaluation-Range of Impaired Functioning Tool ( LIFE-RIFT ) differed from placebo ( P = .03 ) .
RESULTS	Among participants with a MADRS score 25 , NAC separated from placebo at weeks 6 , 8 , 12 , and 16 ( P < .05 ) .
RESULTS	Additionally , the rate of change between baseline and week 16 was significant ( t. = -2.11 , P = .036 ) .
RESULTS	NAC treatment was superior to placebo at week 16 for secondary readouts of function and clinical impression .
RESULTS	Remission and response were greater in the NAC group at week 16 , but not at week 12 .
RESULTS	The NAC group had a greater rate of gastrointestinal and musculoskeletal adverse events .
CONCLUSIONS	Being negative at the week 12 end point , and with some positive secondary signals , the study provides only limited support for the role of NAC as a novel adjunctive therapy for MDD .
CONCLUSIONS	These data implicate the pathways influenced by NAC in depression pathogenesis , principally oxidative and inflammatory stress and glutamate , although definitive confirmation remains necessary .
BACKGROUND	www.anzctr.org.au Identifier : ACTRN12607000134426 .

###25432953
BACKGROUND	Prevention and early detection measures for melanoma , such as sun avoidance and skin examinations , are important , but are practiced inconsistently .
BACKGROUND	In this replication of the Project SCAPE trial , we sought to determine whether tailored print materials were more effective at improving adherence than generic print materials for patients at increased risk of skin cancer .
METHODS	Participants were randomized to receive personalized mailed communications about their skin cancer risk and recommended sun protection , or generic mailings .
METHODS	Participants were Caucasian adults , at moderate or high risk for skin cancer , recruited in outpatient primary care .
METHODS	The main outcomes were overall sun protection behaviors and specific protective behaviors including use of sunscreen , shirt , hat , sunglasses , shade , and sun avoidance ; recent sunburns ; and skin self-examination and provider skin examination .
RESULTS	One hundred ninety-two ( 93.2 % ) subjects completed the study .
RESULTS	Six outcome variables showed significant intervention condition effects in mixed effects models : overall sun protection behavior ( P = 0.025 ) ; sunscreen use ( P = 0.026 ) ; use of sunglasses ( P = 0.011 ) ; sunburns in the past three months ( P = 0.033 ) ; recency of last skin self-exam ( P = 0.017 ) ; and frequency of skin exams by health care provider ( P = 0.016 ) .
CONCLUSIONS	Relative to generic communications , tailored risk communications resulted in improved adherence to six skin cancer protective behaviors , including a composite sun protection behavior measure , sunburns , and health care provider skin examinations .
CONCLUSIONS	Tailored interventions can be more effective in improving patient prevention behaviors than nontailored , generic information for patients at moderate to high risk of skin cancer .

###25589326
BACKGROUND	Existing anthelmintic drugs ( eg , albendazole and mebendazole ) have low efficacy against the intestinal nematode species Trichuris trichiura and the drug pipeline is exhausted .
BACKGROUND	We aimed to investigate the strategy of combination chemotherapy with existing drugs to establish whether their efficacy could be enhanced and broadened .
METHODS	In this randomised controlled trial , we compared three drug combinations and one standard drug alone in children aged 6-14 years in two schools on Pemba Island , Tanzania infected with T trichiura and concomitant intestinal nematodes .
METHODS	We assigned children , via a randomisation list with block sizes of either four or eight , to orally receive albendazole ( 400 mg ) plus ivermectin ( 200 g/kg ) ; albendazole ( 400 mg ) plus mebendazole ( 500 mg ) ; albendazole ( 400 mg ) plus oxantel pamoate ( 20 mg/kg ) ; or mebendazole ( 500 mg ) alone .
METHODS	The primary endpoints were the proportion of children cured of T trichiura infection and the reduction of T trichiura eggs in stool based on geometric means , both analysed by available case .
METHODS	This study is registered with ISRCTN , number ISRCTN80245406 .
RESULTS	We randomly assigned 440 eligible children infected with T trichiura between Sept 2 , and Oct 18 , 2013 , to one of the four treatment groups ( 110 children per group ) .
RESULTS	Data for 431 children were included in the analysis for the primary endpoints .
RESULTS	Albendazole plus oxantel pamoate ( 74 of 108 children cured [ 685 % , 95 % CI 596-774 ] ; egg reduction 992 % , 987-996 ) and albendazole plus ivermectin ( 30 of 109 cured [ 275 % , 190-360 ] ; egg reduction 945 % , 917-963 ) were significantly more effective against T trichiura than mebendazole alone ( nine of 107 cured [ 84 % , 31-138 ] ; egg reduction 585 % , 452-709 ) .
RESULTS	Albendazole plus mebendazole had similar low efficacy ( nine of 107 cured [ 84 % , 31-138 ; egg reduction 516 % , 350-653 ) to mebendazole alone .
RESULTS	About a fifth of the children reported adverse events , which were mainly mild .
RESULTS	Abdominal cramps and headache were the most common adverse events after treatment ; abdominal cramps were reported by 13 ( 120 % ) children for albendazole plus ivermectin , 10 ( 93 % ) for albendazole plus mebendazole , 20 ( 182 % ) for albendazole plus oxantel pamoate , and 16 ( 145 % ) for mebendazole ; headaches were reported by 5 ( 46 % ) children for albendazole plus ivermectin , 6 ( 56 % ) for albendazole plus mebendazole , 12 ( 109 % ) for albendazole plus oxantel pamoate , and 7 ( 64 % ) for mebendazole .
CONCLUSIONS	Our head-to-head comparison of three combination chemotherapies showed the highest efficacy for albendazole plus oxantel pamoate for the treatment of infection with T trichiura .
CONCLUSIONS	Further studies should investigate the combination of albendazole plus oxantel pamoate so that it can be considered for soil-transmitted helminthiasis control programmes .
BACKGROUND	Medicor Foundation and Swiss National Science Foundation .

###25440373
OBJECTIVE	This trial aimed to evaluate the short-term effectiveness of acupuncture plus stretching to reduce pain and improve range of motion in patients afflicted by cervical myofascial pain syndrome .
METHODS	Randomized , blinded , placebo-controlled crossover study .
METHODS	Nineteen patients ( 11 females , eight males , 33 14 years ) with myofascial neck pain in randomized order received the following treatments with one week washout between : acupuncture , acupuncture plus stretching , and placebo laser acupuncture .
METHODS	Mechanical pain threshold ( MPT , measured with a pressure algometer ) represented the primary outcome .
METHODS	Secondary outcomes were motion-related pain ( Visual Analogue Scale , VAS ) and cervical range of motion ( ROM , recorded by means of an ultrasonic 3D movement analysis system ) .
METHODS	Outcomes were assessed immediately prior as well as 5 , 15 and 30 min post treatment .
METHODS	Friedman tests with post hoc Bonferroni-Holm correction were applied to compare differences between treatments .
RESULTS	Both acupuncture as well as acupuncture plus stretching increased MPT by five , respectively , 11 percent post treatment .
RESULTS	However , only acupuncture in combination with stretching was superior to placebo ( p < 0.05 ) .
RESULTS	There were no significant differences between interventions at 15 and 30 min post treatment .
RESULTS	VAS did not differ between treatments at any measurement .
RESULTS	Five minutes after application of acupuncture plus stretching , ROM was significantly increased in the frontal and the transversal plane compared to placebo ( p < 0.05 ) .
CONCLUSIONS	The combination of acupuncture and stretching could represent a suitable treatment option to improve cervical movement behavior and reduce trigger point pain in the short-term .
CONCLUSIONS	However , additional studies further discriminating the placebo effects are still warranted .

###25436815
BACKGROUND	HIV and malaria infections occur in the same individuals , particularly in sub-Saharan Africa .
BACKGROUND	We examined whether daily multivitamin supplementation ( vitamins B complex , C , and E ) or vitamin A supplementation altered malaria incidence in HIV-infected women of reproductive age .
METHODS	HIV-infected pregnant Tanzanian women recruited into the study were randomly assigned to daily multivitamins ( B complex , C , and E ) , vitamin A alone , both multivitamins and vitamin A , or placebo .
METHODS	Women received malaria prophylaxis during pregnancy and were followed monthly during the prenatal and postpartum periods .
METHODS	Malaria was defined in 2 ways : presumptive diagnosis based on a physician 's or nurse 's clinical judgment , which in many cases led to laboratory investigations , and periodic examination of blood smears for malaria parasites .
RESULTS	Multivitamin supplementation compared with no multivitamins significantly lowered women 's risk of presumptively diagnosed clinical malaria ( relative risk : 0.78 , 95 % confidence interval : 0.67 to 0.92 ) , although multivitamins increased their risk of any malaria parasitemia ( relative risk : 1.24 , 95 % confidence interval : 1.02 to 1.50 ) .
RESULTS	Vitamin A supplementation did not change malaria incidence during the study .
CONCLUSIONS	Multivitamin supplements have been previously shown to reduce HIV disease progression among HIV-infected women , and consistent with that , these supplements protected against development of symptomatic malaria .
CONCLUSIONS	The clinical significance of increased risk of malaria parasitemia among supplemented women deserves further research , however .
CONCLUSIONS	Preventive measures for malaria are warranted as part of an integrated approach to the care of HIV-infected individuals exposed to malaria .

###24777150
OBJECTIVE	The use of intravenous proton-pump inhibitors ( PPIs ) has shown to reduce recurrent bleeding and improve patient outcome after endoscopic hemostasis on patients with peptic ulcer .
OBJECTIVE	However , the efficacy of oral PPI is uncertain .
OBJECTIVE	Studies from Asia indicated that even oral PPI can achieve the same therapeutic effect .
OBJECTIVE	This study is designed to compare the efficacy of high-dose intravenous PPI to oral PPI in preventing recurrent bleeding after endoscopic hemostasis .
METHODS	This is a single-center , randomized-controlled , double-blind , and double-dummy study .
METHODS	Patients had Forrest IA/IB or IIA/IIB peptic ulcer bleeding and received endoscopic hemostasis before recruitment into the study .
METHODS	They were randomized to receive either ( i ) esomeprazole IV bolus at a dose of 80 mg plus infusion at 8 mg/h for 72 h and oral placebo every 12 h ( IVP group ) , or ( ii ) IV placebo bolus plus infusion for 72 h and high-dose oral esomeprazole at a dose of 40 mg every 12 h ( ORP group ) .
METHODS	Patients were followed up for 30 days after index bleeding .
METHODS	The primary end point was defined as the 30-day recurrent bleeding after successful endoscopic hemostasis .
RESULTS	A total of 118 patients were randomized to the IVP group and 126 to the ORP group in this study .
RESULTS	In all , 39.8 % in the IVP and 42.9 % in the ORP group used non-steroidal anti-inflammatory drug and/or aspirin before bleeding .
RESULTS	In the IVP group ( vs. ORP ) , Forrest IA represented 1.7 % ( 5.6 % ) , IB 41.5 % ( 38.1 % ) , IIA 52.5 % ( 50.8 % ) , and IIB 4.2 % ( 5.6 % ) .
RESULTS	Recurrent bleeding in 30 days was reported in 7.7 % of patients in the IVP group and 6.4 % of patients in the ORP group , and the difference of recurrent bleeding was -1.3 % ( 95 % CI : -7.7 % , 5.1 % ) .
RESULTS	There was no difference in blood transfusion , repeated endoscopic therapy , and hospital stay between the two groups .
CONCLUSIONS	High-dose oral esomeprazole at 40 mg BID may be considered as a useful alternative to IV bolus plus infusion of esomeprazole in the management of ulcer bleeding in patients who are not candidates for high-dose IV infusion .
CONCLUSIONS	However , as this study was stopped prematurely and was not designed as an equivalency trial , a much larger study would be necessary to document whether there is equivalency or non-inferiority of the two treatments in a heterogeneous patient population .

###24361088
BACKGROUND	The genetic polymorphism of drug metabolizing enzymes of the cytochrome P450 ( CYP ) families , especially CYP2D6 and CYP2C19 , is the most important cause of variable responses of many drugs .
BACKGROUND	Enzyme activity ranges from complete deficiency , so called poor metabolizers ( PMs ) , to an ultrafast metabolism .
BACKGROUND	While PMs and extensive metabolizers ( EMs ) can be well distinguished by genotyping , phenotyping is necessary to subdivide EMs from intermediate metabolizers ( IMs ) .
BACKGROUND	The aim of the study was to evaluate if messenger RNA ( mRNA ) concentration for CYP-enzymes in peripheral blood leukocytes ( PBLs ) will be predictive of systemic enzyme activity , allowing an easy and safe determination of metabolic activity .
METHODS	The genotype , phenotype , and mRNA-expression in PBLs were evaluated in 124 healthy Caucasian volunteers ( males and females , age range 23 - 59 years ) on three occasions ( every 4 weeks ) .
METHODS	Genotyping was performed by Taqman allelic discrimination on the most common null alleles for CYP2D6 ( * 3 , * 4 , * 6 , * 7 , and * 8 ) and CYP2C19 ( * 2 and * 3 ) .
METHODS	For phenotyping CYP2D6 , dextromethorphan/dextrorphan metabolic ratios were determined in collected urine ( 8 hours ) after administration of 30 mg dextromethorphan .
METHODS	For phenotyping CYP2C19 , we used the plasma concentration ratio of omeprazole/hydroxyomeprazole 4 hours after ingestion of 40 mg omeprazole .
METHODS	mRNA-expression in PBLs for CYP2D6 and CYP2C19 was measured by Taqman real-time PCR before medication and 4 hours afterwards .
RESULTS	Genotyping for CYP2D6 and CYP2C19 showed a regular distribution of EMs and PMs compared to studies of a comparable population .
RESULTS	The median dextromethorphan/dextrorphan metabolic ratio was 0.47 in EMs/IMs and 2.29 in PMs .
RESULTS	The median omeprazole/hydroxyomeprazole metabolic ratio was 3.06 in EMs/IMs and 35.29 in PMs .
RESULTS	CYP2D6 and CYP2C19 mRNA expression was detected without evidence of correlation to the respective metabolic ratio .
CONCLUSIONS	The results do not support the concept of using mRNA expression profiles for CYP2D6 and CYP2C19 enzymes in PBLs for prediction of systemic enzyme activity .

###24525115
OBJECTIVE	Lipid emulsions containing fish oil , as source of long chain omega 3 fatty acids , have recently became available for parenteral nutrition in infants , but scanty data exist in extremely low birth weight preterms .
OBJECTIVE	The objective of this study was to compare plasma fatty acids and lipid tolerance in preterm infants receiving different doses of a 15 % fish oil vs. a soybean oil based lipid emulsion .
METHODS	Preterm infants ( birth weight 500-1249g ) were randomized to receive parenteral nutrition with MOSF ( 30 % Medium-chain triglycerides , 25 % Olive oil , 30 % Soybean oil , 15 % Fish oil ) or S ( S , 100 % Soybean oil ) both at two levels of fat intake : 2.5 or 3.5 gkg ( -1 ) d ( -1 ) , named 2.5 Fat and 3.5 Fat respectively .
METHODS	Plasma lipid classes and their fatty acid composition were determined on postnatal day 7 and 14 by gas chromatography together with routine biochemistry .
RESULTS	We studied 80 infants .
RESULTS	MOSF infants had significantly higher plasma phospholipid Docosahexaenoic acid and Eicosapentaenoic and lower Arachidonic acid .
RESULTS	Plasma phospholipids , triglycerides and free cholesterol were all significantly higher in the MOSF-3 .5 Fat group , while cholesterol esters were lower with MOSF than with S.
RESULTS	The area under the curve of total bilirubin was significantly lower with MOSF than with S.
CONCLUSIONS	The use of a lipid emulsion with 15 % FO resulted in marked changes of plasma long-chain fatty acids .
CONCLUSIONS	Whether the benefits of increasing Docosahexaenoic acid outweigh the potential negative effect of reduced Arachidonic acid should be further studied .
CONCLUSIONS	MOSF patients exhibited reduced lipid tolerance at 3.5 gkg ( -1 ) d ( -1 ) fat intake .
CONCLUSIONS	The trial was conducted between January 2008 and December 2012 so we had not registered it in a public trials registry as it is now required for trials that started after July 2008 .

###25595236
BACKGROUND	Meningococcal disease is rare but can cause death or disabilities .
BACKGROUND	Although the Advisory Committee on Immunization Practices has recommended meningococcal vaccination for at-risk children aged 9 through 23 months , it has not endorsed universal vaccination .
BACKGROUND	Health insurance payments for the vaccination of children who are not at risk are likely to be limited.Use of infant meningococcal vaccines by these families will thus depend on the preferences of physicians who might recommend vaccination to parents , as well as parents ' preferences .
OBJECTIVE	To quantify pediatricians ' preferences for specific features of hypothetical infant meningococcal vaccines .
METHODS	A sample of pediatricians ( n = 216 ) completed a Web-enabled , discrete choice experiment survey in which respondents chose between pairs of hypothetical vaccines in a series of trade-off questions .
METHODS	The questions described vaccines with six attributes .
METHODS	A random-parameters logit regression model was used to estimate the relative importance weights physicians place on vaccine features .
METHODS	These weights were used to calculate the predicted probability that a physician chooses hypothetical vaccines with given characteristics .
RESULTS	Pediatricians ' choices indicated that increases in vaccine effectiveness were among the most important factors in their vaccine recommendations , followed by increases in the number of injections .
RESULTS	The age at which protection begins and the number of additional office visits were less important .
RESULTS	Whether a booster was required after 5 years was the least important factor in vaccine recommendations .
RESULTS	The results suggest that virtually all ( 99.9 % ) physicians in the sample would recommend a vaccine even with the least-preferred features rather than no infant meningococcal vaccine .
CONCLUSIONS	Physicians ' responses indicate a strong preference for infant meningococcal vaccination .

###25173541
BACKGROUND	The perceived risk of serious bleeding is an obstacle to the use of oral anticoagulation in East Asia .
BACKGROUND	The efficacy and safety of apixaban in East Asian patients with atrial fibrillation are unknown .
METHODS	ARISTOTLE included 18,201 patients with nonvalvular atrial fibrillation randomized to apixaban 5mg twice daily or warfarin .
METHODS	The efficacy and safety of apixaban and warfarin among patients recruited from East Asia ( n = 1,993 ) were compared with those recruited from outside East Asia ( n = 16,208 ) .
RESULTS	Compared with warfarin , apixaban resulted in a consistent reduction in stroke or systemic embolism in East Asian ( hazard ratio [ HR ] 0.74 , 95 % CI 0.50-1 .10 ) and non-East Asian ( HR 0.81 , 95 % CI 0.66-0 .99 ) patients ( interaction P = .70 ) .
RESULTS	Consistent benefits of apixaban over warfarin were also seen for major bleeding in East Asian ( HR 0.53 , 95 % CI 0.35-0 .80 ) and non-East Asian ( HR 0.72 , 95 % CI 0.62-0 .83 ) patients ( interaction P = .17 ) .
RESULTS	There was a greater reduction in major or clinically relevant nonmajor bleeding with apixaban compared with warfarin in East Asian ( HR 0.49 , 95 % CI 0.35-0 .67 ) than in non-East Asian ( HR 0.71 , 95 % CI 0.63-0 .79 ) patients ( interaction P = .03 ) .
RESULTS	Numerically higher rates of intracranial bleeding were seen in East Asian patients with warfarin but not with apixaban .
CONCLUSIONS	Apixaban resulted in similar reductions in stroke or systemic embolism and major bleeding and greater reductions in major or clinically relevant nonmajor bleeding in patients from East Asia .
CONCLUSIONS	Warfarin is associated with more intracranial bleeding , particularly in patients from East Asia .

###24679633
BACKGROUND	Inhibition of tumor angiogenesis by the interruption of VEGF pathway signaling is of therapeutic value in several solid tumors .
BACKGROUND	Preclinical evidence supports similar importance of the pathway in non-Hodgkin lymphoma .
BACKGROUND	In this randomized phase II trial , we compared the efficacy and toxicity of rituximab with bevacizumab versus single-agent rituximab , in patients with previously-treated follicular lymphoma .
METHODS	Patients ( n = 60 ) were randomized ( 1:1 ) to receive rituximab ( 375 mg/m ( 2 ) intravenously [ I.V. ] weekly for 4 weeks ) either as a single agent or with bevacizumab ( 10 mg/kg I.V. on days 3 and 15 ) .
METHODS	Patients with an objective response or stable disease at week 12 received 4 additional doses of rituximab ( at months 3 , 5 , 7 , and 9 ) ; patients who received rituximab/bevacizumab also received bevacizumab 10 mg/kg I.V. every 2 weeks for 16 doses .
RESULTS	After a median follow-up of 34 months , PFS was improved in patients who received rituximab/bevacizumab compared with patients who received rituximab alone ( median 20.7 vs. 10.4 months respectively ; HR , 0.40 ( 95 % confidence interval [ CI ] , 0.20-0 .80 ) ; P = .007 ) .
RESULTS	Overall survival was also improved numerically ( 73 % vs. 53 % at 4 years ) , but did not reach statistical significance ( HR , 0.40 ( 95 % CI , 0.15-1 .05 ) ; P = .055 ) .
RESULTS	The addition of bevacizumab increased the toxicity of therapy , but both regimens were well tolerated ( no grade 4 toxicity ) .
CONCLUSIONS	The addition of bevacizumab to rituximab significantly improved PFS .
CONCLUSIONS	The role of angiogenesis inhibition in the treatment of follicular lymphoma requires further definition in larger clinical trials .

###24595547
OBJECTIVE	Apremilast , an oral phosphodiesterase 4 inhibitor , regulates inflammatory mediators .
OBJECTIVE	Psoriatic Arthritis Long-term Assessment of Clinical Efficacy 1 ( PALACE 1 ) compared apremilast with placebo in patients with active psoriatic arthritis despite prior traditional disease-modifying antirheumatic drug ( DMARD ) and/or biologic therapy .
METHODS	In the 24-week , placebo-controlled phase of PALACE 1 , patients ( N = 504 ) were randomised ( 1:1:1 ) to placebo , apremilast 20 mg twice a day ( BID ) or apremilast 30 mg BID .
METHODS	At week 16 , patients without 20 % reduction in swollen and tender joint counts were required to be re-randomised equally to either apremilast dose if initially randomised to placebo or remained on their initial apremilast dose .
METHODS	Patients on background concurrent DMARDs continued stable doses ( methotrexate , leflunomide and/or sulfasalazine ) .
METHODS	Primary outcome was the proportion of patients achieving 20 % improvement in modified American College of Rheumatology response criteria ( ACR20 ) at week 16 .
RESULTS	At week 16 , significantly more apremilast 20 mg BID ( 31 % ) and 30 mg BID ( 40 % ) patients achieved ACR20 versus placebo ( 19 % ) ( p < 0.001 ) .
RESULTS	Significant improvements in key secondary measures ( physical function , psoriasis ) were evident with both apremilast doses versus placebo .
RESULTS	Across outcome measures , the 30-mg group generally had higher and more consistent response rates , although statistical comparison was not conducted .
RESULTS	The most common adverse events were gastrointestinal and generally occurred early , were self-limiting and infrequently led to discontinuation .
RESULTS	No imbalance in major adverse cardiac events , serious or opportunistic infections , malignancies or laboratory abnormalities was observed .
CONCLUSIONS	Apremilast was effective in the treatment of psoriatic arthritis , improving signs and symptoms and physical function .
CONCLUSIONS	Apremilast demonstrated an acceptable safety profile and was generally well tolerated .
BACKGROUND	NCT01172938 .

###24238860
OBJECTIVE	To define longitudinal childhood wheeze phenotypes and identify their early-life risk factors .
METHODS	Current wheeze was recorded 23 times up to age 7 years in a birth cohort at high risk for allergy ( n = 620 ) .
METHODS	Latent class analysis of wheeze responses identified 5 classes .
METHODS	Multinomial logistic regression estimated associations of probability-weighted wheezing classes with early-life factors .
METHODS	All phenotypes were compared with never/infrequent wheezers .
RESULTS	Lower respiratory tract infection ( LRTI ) by 1 year ( relative risk [ RR ] , 3.00 ; 95 % CI , 1.58-5 .70 ) , childcare by 1 year ( RR , 1.51 ; 95 % CI , 1.02-2 .22 ) , and higher body mass index ( RR , 2.51 ; 95 % CI , 1.09-5 .81 ) were associated with increased risk of early transient wheeze , whereas breastfeeding was protective ( RR , 0.54 ; 95 % CI , 0.32-0 .90 ) .
RESULTS	LRTI ( RR , 6.54 ; 95 % CI , 2.55-16 .76 ) and aeroallergen sensitization ( RR , 4.95 ; 95 % CI , 1.74-14 .02 ) increased the risk of early persistent wheeze .
RESULTS	LRTI ( RR , 5.31 ; 95 % CI , 2.71-10 .41 ) , eczema ( RR , 2.77 ; 95 % CI , 1.78-4 .31 ) , aeroallergen sensitization ( RR , 5.60 ; 95 % CI , 2.86-10 .9 ) , and food sensitization ( RR , 2.77 ; 95 % CI , 1.56-4 .94 ) increased the risk of intermediate-onset wheeze , whereas dog exposure at baseline ( RR , 0.52 ; 95 % CI , 0.32-0 .84 ) and first-born status ( RR , 0.49 ; 95 % CI , 0.32-0 .76 ) were protective .
RESULTS	Heavy parental smoking at birth ( RR , 3.18 ; 95 % CI , 1.02-9 .88 ) increased the risk of late-onset wheeze , whereas breastfeeding reduced it ( RR , 0.34 ; 95 % CI , 0.12-0 .96 ) .
RESULTS	All wheeze classes except early transient had greater risk of wheeze at age 12 years compared with never/infrequent wheezers .
CONCLUSIONS	We found distinct early-life risk factor profiles for each wheeze phenotype .
CONCLUSIONS	These findings provide insight into possible wheeze mechanisms and have implications for identifying preventive strategies and addressing clinical management of early-life wheeze .

###25919246
BACKGROUND	The authors sought to compare the newest U.S. Food and Drug Administration-approved botulinum toxin type A product , incobotulinumtoxinA , to onabotulinumtoxinA for upper face wrinkles .
BACKGROUND	This is the first prospective , split-face , randomized , double-blind study addressing three types of facial wrinkles using a 1:1 dose ratio .
METHODS	The study was designed , institutional review board approval was obtained , and 45 patients were enrolled .
METHODS	A three-judge independent reviewer panel compared photographs of patients to the upper face validated assessment scales , selecting a grade ranging from 0 ( no lines ) to 4 ( very severe ) for the degree of glabellar lines , crow 's feet , and forehead lines for each side of the face for photographs taken before treatment and 3 days , 2 weeks , 3 months , and 4 months after treatment .
METHODS	For toxin comparison , the difference in the magnitude of the degree of wrinkle scale at each period compared to before treatment was calculated and statistical analysis performed .
METHODS	Individual wrinkle types and all three wrinkle types combined were analyzed .
RESULTS	Both products offered significant reduction in individual and combined wrinkles at comparable time points ; however , onabotulinumtoxinA had significantly greater combined dynamic wrinkle reduction at 3 days ( p < 0.010 ) , 2 weeks ( p < 0.008 ) , 3 months ( p < 0.013 ) , and 4 months ( p < 0.045 ) .
CONCLUSIONS	For identical dosage , both onabotulinumtoxinA and incobotulinumtoxinA are safe and effective in reducing dynamic wrinkles in the upper face ; however , for the authors ' dosages , onabotulinumtoxinA had statistically greater efficacy at 3 days , 2 weeks , 3 months , and 4 months .
METHODS	Therapeutic , II .

###25263498
OBJECTIVE	To investigate the efficacy of a single prophylactic dose of ampicillin combined with metronidazole to prevent postcesarean section infections compared with a multiple day regimen in low-resource settings .
METHODS	An evaluator-blinded randomized , controlled , noninferiority trial .
METHODS	Two rural hospitals in Tanzania .
METHODS	Of 181 enrolled eligible women with an indication for cesarean section , information on 176 was analyzed by intention-to-treat .
METHODS	The women were randomly assigned to either the intervention group who received a single dose of ampicillin and metronidazole , or to the control group who received a multiple-day regimen of ampicillin/amoxicillin and metronidazole .
METHODS	The primary outcome was maternal postcesarean infection .
METHODS	Secondary outcomes were severity of these infections , other maternal complications , and the duration of hospital stay .
RESULTS	In the intervention group ( n = 89 ) , six women ( 6.7 % ) developed a wound infection compared with nine ( 10.3 % ) in the control group ( n = 87 ) ( difference 3.60 ; 95 % CI -4.65 to 11.85 ) ( p = 0.40 ) .
CONCLUSIONS	A single dose of prophylactic ampicillin and metronidazole is equally effective as a multiple-day regimen in preventing postcesarean wound infections in low-resource settings , therefore it can be considered as a good strategy in low-resource settings .
CONCLUSIONS	The reduced quantity of prophylactic antibiotics will reduce costs without increasing the risk of maternal infection .

###24895454
BACKGROUND	Nonvalvular atrial fibrillation is common in elderly patients , who face an elevated risk of stroke but difficulty sustaining warfarin treatment .
BACKGROUND	The oral factor Xa inhibitor rivaroxaban was noninferior to warfarin in the Rivaroxaban Once Daily , Oral , Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation ( ROCKET AF ) .
BACKGROUND	This prespecified secondary analysis compares outcomes in older and younger patients .
RESULTS	There were 6229 patients ( 44 % ) aged 75 years with atrial fibrillation and 2 stroke risk factors randomized to warfarin ( target international normalized ratio = 2.0-3 .0 ) or rivaroxaban ( 20 mg daily ; 15 mg if creatinine clearance < 50 mL/min ) , double blind .
RESULTS	The primary end point was stroke and systemic embolism by intention to treat .
RESULTS	Over 10 866 patient-years , older participants had more primary events ( 2.57 % versus 2.05 % / 100 patient-years ; P = 0.0068 ) and major bleeding ( 4.63 % versus 2.74 % / 100 patient-years ; P < 0.0001 ) .
RESULTS	Stroke/systemic embolism rates were consistent among older ( 2.29 % rivaroxaban versus 2.85 % warfarin per 100 patient-years ; hazard ratio = 0.80 ; 95 % confidence interval , 0.63-1 .02 ) and younger patients ( 2.00 % versus 2.10 % / 100 patient-years ; hazard ratio = 0.95 ; 95 % confidence interval , 0.76-1 .19 ; interaction P = 0.313 ) , as were major bleeding rates ( 75 years : 4.86 % rivaroxaban versus 4.40 % warfarin per 100 patient-years ; hazard ratio = 1.11 ; 95 % confidence interval , 0.92-1 .34 ; < 75 years : 2.69 % versus 2.79 % / 100 patient-years ; hazard ratio = 0.96 ; 95 % confidence interval , 0.78-1 .19 ; interaction P = 0.336 ) .
RESULTS	Hemorrhagic stroke rates were similar in both age groups ; there was no interaction between age and rivaroxaban response .
CONCLUSIONS	Elderly patients had higher stroke and major bleeding rates than younger patients , but the efficacy and safety of rivaroxaban relative to warfarin did not differ with age , supporting rivaroxaban as an alternative for the elderly .

###24596910
OBJECTIVE	The aim of this study was to investigate if argon plasma cleaning increases the shear bond strength between zirconia and veneering ceramic surfaces .
METHODS	Ninety tablets of densely sintered yttriastabilized tetragonal zirconia polycrystal were divided into three groups according to cleaning treatment ( steam cleaning or plasma of Argon for 375 or 750 seconds ) .
METHODS	Groups were divided into two subgroups according to the application of a ceramic liner ( A = liner , B = no liner ) .
RESULTS	Within subgroup A , argon plasma cleaning significantly decreased shear bond strength .
RESULTS	In subgroup B , the plasma treatment increased the shear bond strength , but the differences were not statistically significant .
RESULTS	Subgroup A demonstrated lower shear bond strength compared to subgroup B.
CONCLUSIONS	Argon plasma cleaning was suggested to improve the bond between ceramic and zirconia surfaces ; however , when plasma cleaning was followed by a glassy liner application , the veneering ceramic/zirconia bond was significantly reduced .

###24518614
OBJECTIVE	To identify variables that predict adherence with annual eye examinations using the Compliance with Annual Diabetic Eye Exams Survey ( CADEES ) , a new questionnaire designed to measure health beliefs related to diabetic retinopathy and annual eye examinations .
METHODS	Questionnaire development .
METHODS	Three hundred sixteen adults with diabetes .
METHODS	We developed the CADEES based on a review of the literature , the framework of the Health Belief Model , expert opinion , and pilot study data .
METHODS	To examine content validity , we analyzed participant responses to an open-ended question asking for reasons why people do not obtain annual eye examinations .
METHODS	We evaluated construct validity with principal components analysis and examined internal consistency with Cronbach 's .
METHODS	To assess predictive validity , we used multivariate logistic regression with self-reported adherence as the dependent variable .
METHODS	Associations with self-reported adherence ( defined as having a dilated eye examination in the past year ) .
RESULTS	The content analysis showed that CADEES items covered 89 % of the reasons given by participants for not obtaining an annual eye examination .
RESULTS	The principal components analysis identified 3 informative components that made up 32 % of the variance .
RESULTS	Multivariate logistic regression modeling revealed several significant predictors of adherence , including beliefs concerning whether insurance covered most of the eye examination cost ( P < 0.01 ) , whether there were general barriers that make it difficult to obtain an eye examination ( P < 0.01 ) , whether obtaining an eye examination was a top priority ( P = 0.02 ) , and whether diabetic eye disease can be seen with an examination ( P = 0.05 ) .
RESULTS	Lower hemoglobin A1c levels ( P < 0.01 ) , having insurance ( P = 0.01 ) , and a longer duration of diabetes ( P = 0.02 ) also were associated with adherence .
RESULTS	A multivariate model containing CADEES items and demographic variables classified cases with 72 % accuracy and explained approximately 24 % of the variance in adherence .
CONCLUSIONS	The CADEES showed good content and predictive validity .
CONCLUSIONS	Although additional research is needed before finalizing a shorter version of the survey , our findings suggest that researchers and clinicians may be able to improve adherence by ( 1 ) counseling newly diagnosed patients , as well as those with uncontrolled blood glucose , on the importance of annual eye examinations and ( 2 ) discussing perceived barriers and misconceptions .

###25175303
BACKGROUND	In many units , the standard mesh ratio is 1.5:1 , but in our unit we have a 1:1 mesher , which does not expand the skin but provides regular fenestrations .
BACKGROUND	There is some evidence that the unexpanded 1.5:1 meshed graft compares favourably with sheet grafts from a cosmetic perspective whilst reducing the risk of graft failure secondary to a subgraft haematoma , but none comparing the 1:1 meshed graft with the sheet graft .
BACKGROUND	We conducted a randomized trial to compare surgical outcomes in unfenestrated sheet grafts with 1:1 meshed grafts .
METHODS	All patients aged 16 years undergoing skin grafts with either a sheet or a 1:1 mesh for burn reconstruction were included .
METHODS	Patients on steroids , those with conditions that impair healing , and burns > 20 % were excluded .
METHODS	Patients were randomized into the sheet grafting or mesh graft using a computer-generated allocation system .
METHODS	The mean percentage of graft loss was assessed by a Visitrak overlay system .
METHODS	At 3-4 months , 7-8 months and at 1 year , photos were taken for scar assessment using the Vancouver Scar Score ( VSS ) .
RESULTS	Out of 72 patients , 48 patients ( 24 sheet vs. 24 mesh ) completed the trial at 12 months .
RESULTS	The mean age was 58 years ( range 21-90 ) .
RESULTS	There was no total loss of graft in either group .
RESULTS	The mean percentage of graft loss due to haematoma formation was higher in the sheet graft group ( 10 % ) compared to the 1:1 mesh group ( 6 % ) ( P < 0.062 ) .
RESULTS	The VSS score was 5 in both groups at 12 months .
RESULTS	There was no significant difference in scar quality between the treatment groups .
CONCLUSIONS	These results show that the 1:1 mesh graft is superior to the sheet graft with regard to graft loss , although this result is not statistically significant .
CONCLUSIONS	There are comparable findings in terms of cosmetic perspective at 12 months post-operatively in both arms of the trial .

###25390695
BACKGROUND	No data from controlled trials exists regarding the inflammatory response in patients with de novo heart failure ( HF ) complicating ST-elevation myocardial infarction ( STEMI ) and a possible role in the recovery of contractile function .
BACKGROUND	We therefore explored the time course and possible associations between levels of inflammatory markers and recovery of impaired left ventricular function as well as levosimendan treatment in STEMI patients in a substudy of the LEvosimendan in Acute heart Failure following myocardial infarction ( LEAF ) trial .
METHODS	A total of 61 patients developing HF within 48 hours after a primary PCI-treated STEMI were randomised double-blind to a 25 hours infusion of levosimendan or placebo .
METHODS	Levels of IL-6 , CRP , sIL-6R , sgp130 , MCP-1 , IL-8 , MMP-9 , sICAM-1 , sVCAM-1 and TNF - were measured at inclusion ( median 22 h , interquartile range ( IQR ) 14 , 29 after PCI ) , on day 1 , day 2 , day 5 and 6 weeks .
METHODS	Improvement in left ventricular function was evaluated as change in wall motion score index ( WMSI ) by echocardiography .
RESULTS	Only circulating levels of IL-8 at inclusion were associated with change in WMSI from baseline to 6 weeks , r = 0.41 ( p = 0.002 ) .
RESULTS	No association , however , was found between IL-8 and WMSI at inclusion or peak troponin T. Furthermore , there was a significant difference in change in WMSI from inclusion to 6 weeks between patients with IL-8 levels below , compared to above median value , 0.44 ( IQR 0.57 , 0.19 ) vs. 0.07 ( IQR 0.27 , 0.07 ) , respectively ( p < 0.0001 ) .
RESULTS	Levosimendan did not affect the levels of inflammary markers compared to control .
CONCLUSIONS	High levels of IL-8 in STEMI patients complicated with HF were associated with less improvement in left ventricular function during the first 6 weeks after PCI , suggesting a possible role of IL-8 in the reperfusion-related injury of post-ischemic myocardium .
CONCLUSIONS	Further studies are needed to confirm this hypothesis .
BACKGROUND	ClinicalTrials.gov NCT00324766 .

###25823174
OBJECTIVE	To evaluate the effect of an intervention based on the Precede-Proceed Model on attitudes towards prevention of Domestic Violence among Iranian girls .
METHODS	The randomised controlled trial was conducted during 2010-11 at 10 high schools in District 17 ofTehran Municipality in Iran .
METHODS	The subjects were divided into two equal groups of cases and controls .
METHODS	Components of the Precede-Proceed Model for planning , implementation and evaluation of the study .
METHODS	After need assessment , an appropriate environmental and educational intervention was implemented in the intervention group .
METHODS	Changes in predisposing , reinforcing , enabling factors and especially attitudes towards prevention of Domestic Violence immediately and two months after the intervention were assessed in by questionnaires based on the Precede-Proceed Model .
METHODS	SPSS 18 was used for statistical analyses .
RESULTS	There were 510 students who comprised the study population , with 255 individuals in each of the two groups .
RESULTS	The intervention had significantly positive effect on predisposing , enabling and reinforcing factors immediately and two months after the intervention ( p < 0.05 ) .
RESULTS	Repeated measures analysis of variance showed a significant positive increase in attitude score in the intervention group from baseline to two months ( p < 0.001 ) .
CONCLUSIONS	The Precede-Proceed Model is one of the most widely used health planning models for identifying factors that influence health behaviours associated with domestic violence .
CONCLUSIONS	Implementation of an educational programme based on the model among young girls was effective in changing attitude towards domestic violence .

###25058083
OBJECTIVE	High-dose immunosuppressive therapy and autologous hematopoietic stem cell transplantation ( HSCT ) have shown efficacy in systemic sclerosis in phase 1 and small phase 2 trials .
OBJECTIVE	To compare efficacy and safety of HSCT vs 12 successive monthly intravenous pulses of cyclophosphamide .
METHODS	The Autologous Stem Cell Transplantation International Scleroderma ( ASTIS ) trial , a phase 3 , multicenter , randomized ( 1:1 ) , open-label , parallel-group , clinical trial conducted in 10 countries at 29 centers with access to a European Group for Blood and Marrow Transplantation-registered transplant facility .
METHODS	From March 2001 to October 2009 , 156 patients with early diffuse cutaneous systemic sclerosis were recruited and followed up until October 31 , 2013 .
METHODS	HSCT vs intravenous pulse cyclophosphamide .
METHODS	The primary end point was event-free survival , defined as time from randomization until the occurrence of death or persistent major organ failure .
RESULTS	A total of 156 patients were randomly assigned to receive HSCT ( n = 79 ) or cyclophosphamide ( n = 77 ) .
RESULTS	During a median follow-up of 5.8 years , 53 events occurred : 22 in the HSCT group ( 19 deaths and 3 irreversible organ failures ) and 31 in the control group ( 23 deaths and 8 irreversible organ failures ) .
RESULTS	During the first year , there were more events in the HSCT group ( 13 events [ 16.5 % ] , including 8 treatment-related deaths ) than in the control group ( 8 events [ 10.4 % ] , with no treatment-related deaths ) .
RESULTS	At 2 years , 14 events ( 17.7 % ) had occurred cumulatively in the HSCT group vs 14 events ( 18.2 % ) in the control group ; at 4 years , 15 events ( 19 % ) had occurred cumulatively in the HSCT group vs 20 events ( 26 % ) in the control group .
RESULTS	Time-varying hazard ratios ( modeled with treatmenttime interaction ) for event-free survival were 0.35 ( 95 % CI , 0.16-0 .74 ) at 2 years and 0.34 ( 95 % CI , 0.16-0 .74 ) at 4 years .
CONCLUSIONS	Among patients with early diffuse cutaneous systemic sclerosis , HSCT was associated with increased treatment-related mortality in the first year after treatment .
CONCLUSIONS	However , HCST conferred a significant long-term event-free survival benefit .
BACKGROUND	isrctn.org Identifier : ISRCTN54371254 .

###25079933
OBJECTIVE	To analyse if predictors of radiographic progression differ between patients treated with or without prednisolone in early rheumatoid arthritis ( RA ) .
OBJECTIVE	Radiographs of hands and feet were assessed using the modified Sharp/van der Heijde score and radiographic progression was defined as an increase in the total Sharp score above 5.8 ( the smallest detectable change ) .
METHODS	Prospective , randomised study of patients with early RA .
METHODS	Secondary level of care ; six participating centres from southern Sweden ; both urban and rural populations .
METHODS	In all , 225 patients , 64 % women , with a diagnosis of RA according to the American College of Rheumatology criteria , were included if they were between 18 and 80years of age and had a disease duration of less than 1year .
METHODS	The patients were randomised to 7.5 mg prednisolone daily for 2years ( P-group ; n = 108 ) or no prednisolone ( NoP-group ; n = 117 ) when they started with their first disease-modifying anti-rheumatic drug and were prospectively followed for 2years .
RESULTS	The frequency of patients with radiographic progression after 2years was 26 % in the P-group and 39 % in the NoP-group ( p = 0.033 ) .
RESULTS	Relevant interactions between treatment and rheumatoid factor ( RF ) ( p = 0.061 ) and between treatment and anti-cyclic citrullinated peptide 2 ( anti-CCP ) ( p = 0.096 ) were found .
RESULTS	RF and anti-CCP independently predicted radiographic progression only in the NoP-group , OR ( 95 % CI ) 9.4 ( 2.5 to 35.2 ) , p = 0.001 and OR ( 95 % CI ) 8.7 ( 2.5 to 31.3 ) , p = 0.001 , respectively .
CONCLUSIONS	The presence of RF and anti-CCP predicted radiographic progression in patients not treated with prednisolone but failed to predict progression in patients treated with this drug .
CONCLUSIONS	The data suggest that early treatment with prednisolone may modulate not only inflammation but also autoimmunity-associated pathogenetic mechanisms .
BACKGROUND	ISRCTN20612367 .

###25928649
BACKGROUND	Black individuals with lung cancer ( LC ) experience higher mortality because they present with more advanced disease and are less likely to undergo curative resection for early-stage disease .
BACKGROUND	The National Lung Screening Trial ( NLST ) demonstrated improved LC mortality by screening high-risk patients with low-dose computed tomography ( LDCT ) .
BACKGROUND	The benefit of LDCT screening in black individuals is unknown .
OBJECTIVE	Examine results of the NLST by race .
METHODS	This was a secondary analysis of a randomized trial ( NCT00047385 ) performed in 33 U.S. centers .
RESULTS	Overall and lung cancer-specific mortality were measured .
RESULTS	Screening with LDCT reduced LC mortality in all racial groups but more so in black individuals ( hazard ratio [ HR ] , 0.61 vs. 0.86 ) .
RESULTS	Smoking increased the likelihood of death from LC , and when stratified by race black smokers were twice as likely to die as white smokers ( HR , 4.10 vs. 2.25 ) .
RESULTS	Adjusting for sociodemographic and behavioral characteristics , black individuals experienced higher all-cause mortality than white individuals ( HR , 1.35 ; 95 % confidence interval , 1.22-1 .49 ) ; however , black individuals screened with LDCT had a reduction in all-cause mortality .
RESULTS	Black individuals were younger , were more likely to be current smokers , had more comorbidities , and had fewer years of formal education than white individuals ( P < 0.05 ) .
CONCLUSIONS	Black individuals screened with LDCT had decreased mortality from lung cancer .
CONCLUSIONS	However , the demographics associated with improved LC survival were less commonly found in black individuals .
CONCLUSIONS	The overall mortality in the NLST was higher for black individuals than white individuals , but improved in black individuals screened , suggesting that this subgroup may have had improved access to care .
CONCLUSIONS	To realize the reductions in mortality from LC screening , dissemination efforts need to be tailored to meet the needs of this community .

###24970272
BACKGROUND	Vasopressor administration is recommended to prevent hypotension during spinal anaesthesia ( SA ) for elective Caesarean delivery .
BACKGROUND	We aimed to test the superior efficacy and ensure safety of a hydroxyethyl starch ( HES ) vs a Ringer 's lactate ( RL ) preloading , when combined with a phenylephrine-based prophylaxis .
METHODS	A total of 167 healthy parturients undergoing elective Caesarean delivery under SA were included in this multicentre , randomized , double-blind study .
METHODS	Patients received 500 ml of 6 % HES ( 130/0 .4 ) +500 ml of RL ( HES group ) or 1000 ml of RL ( RL group ) i.v. before SA .
METHODS	After SA , i.v. phenylephrine boluses were titrated when systolic arterial pressure ( SAP ) was below 95 % of baseline .
METHODS	The primary outcome was the incidence of maternal hypotension ( SAP < 80 % of baseline ) .
RESULTS	The incidence of both hypotension and symptomatic hypotension ( i.e. with dizziness , nausea/vomiting , or both ) was significantly lower in the HES group vs the RL group : 36.6 % vs 55.3 % ( one-sided P = 0.025 ) and 3.7 % vs 14.1 % .
RESULTS	There was no significant difference in total phenylephrine requirements [ median ( range ) : 350 ( 50-1800 ) vs 350 ( 50-1250 ) g ] .
RESULTS	The decrease in maternal haemoglobin value the day after surgery was similar in the two groups [ 1.2 ( 1.0 ) vs 1.0 ( 0.9 ) g dl ( -1 ) ] .
RESULTS	There was no detectable placental transfer of HES in six umbilical cord blood samples analysed in the HES group .
RESULTS	Neonatal outcomes were comparable between the groups .
CONCLUSIONS	Compared with a pure RL preloading , a mixed HES-RL preloading significantly improved prevention of both hypotension and symptomatic hypotension based on early phenylephrine bolus administration and did not induce adverse effects .
BACKGROUND	NCT00694343 ( http://clinicaltrials.gov ) .

###25458454
OBJECTIVE	The aim of this study was to compare the efficacy of HES 130/0 .4 coloading compared to normal saline solution for prevention of hypotension during spinal anesthesia for elective caesarean section .
METHODS	Prospective , randomized .
METHODS	One hundred and twenty ASA I and II patients scheduled for elective caesarean section were recruited .
METHODS	Patients were randomized to receive either 500mL of HES 130/0 .4 ( Voluven ( ) ) coloading ( GroupV ) or 500mL of normal saline solution coloading ( GroupC ) .
METHODS	Spinal anesthesia technique and ephedrine administration were standardized in both groups .
METHODS	The primary endpoint was the incidence of maternal hypotension during spinal anesthesia for elective caesarean section .
RESULTS	Hypotension occurred in 43 patients in group C and 24 patients in group V ( p = 0.001 ) .
RESULTS	Ephedrine consumption was significantly lower in group V ( P = 0.005 ) .
RESULTS	Nausea , vomiting and headache incidence was higher in group C ( p = 0.006 ) .
RESULTS	Apgar scores and umbilical blood gazes were comparable between groups .
CONCLUSIONS	HES 130/0 .4 coload was more effective than normal saline solution to prevent hypotension following spinal anesthesia for elective cesarean section .
CONCLUSIONS	HES 130/0 .4 coload reduced the incidence , the duration of longest hypotension , the need for ephedrine and the adverse maternal effects .

###24679384
BACKGROUND	Newer approaches for understanding suicidal behavior suggest the assessment of suicide-specific beliefs and cognitions may improve the detection and prediction of suicidal thoughts and behaviors .
BACKGROUND	The Suicide Cognitions Scale ( SCS ) was developed to measure suicide-specific beliefs , but it has not been tested in a military setting .
METHODS	Data were analyzed from two separate studies conducted at three military mental health clinics ( one U.S. Army , two U.S. Air Force ) .
METHODS	Participants included 175 active duty Army personnel with acute suicidal ideation and/or a recent suicide attempt referred for a treatment study ( Sample 1 ) and 151 active duty Air Force personnel receiving routine outpatient mental health care ( Sample 2 ) .
METHODS	In both samples , participants completed self-report measures and clinician-administered interviews .
METHODS	Follow-up suicide attempts were assessed via clinician-administered interview for Sample 1 .
METHODS	Statistical analyses included confirmatory factor analysis , between-group comparisons by history of suicidality , and generalized regression modeling .
RESULTS	Two latent factors were confirmed for the SCS : Unloveability and Unbearability .
RESULTS	Each demonstrated good internal consistency , convergent validity , and divergent validity .
RESULTS	Both scales significantly predicted current suicidal ideation ( s > 0.316 , ps < 0.002 ) and significantly differentiated suicide attempts from nonsuicidal self-injury and control groups ( F ( 6 , 286 ) = 9.801 , p < 0.001 ) .
RESULTS	Both scales significantly predicted future suicide attempts ( AORs > 1.07 , ps < 0.050 ) better than other risk factors .
CONCLUSIONS	Self-report methodology , small sample sizes , predominantly male samples .
CONCLUSIONS	The SCS is a reliable and valid measure that predicts suicidal ideation and suicide attempts among military personnel better than other well-established risk factors .

###25268306
OBJECTIVE	Standard clips do not consistently prevent the migration of covered self-expanding metal stents ( SEMS ) .
OBJECTIVE	The aims of this study were to assess the efficacy and safety of the over-the-scope clip ( OTSC ) system for anchoring SEMS to the esophagus , and to evaluate a novel OTSC removal technique .
METHODS	This was a single-center , retrospective , cohort study of consecutive patients undergoing SEMS anchoring with OTSC .
METHODS	Removal of the OTSC was accomplished using an inject-and-resect technique .
RESULTS	A total of 12 patients were included .
RESULTS	The indications for endoscopic stenting were : tracheo-esophageal fistula ( n = 7 ) , postoperative leak or fistula ( n = 4 ) , perforation ( n = 1 ) .
RESULTS	Successful application of the OTSC system was accomplished in all patients ( 100 % ) .
RESULTS	Stent migration during follow-up ( mean 3 weeks , range 2-4 weeks ) occurred in two patients ( 16.7 % ) .
RESULTS	After healing of the underlying condition , the stent was removed in six patients ( 50.0 % ) .
RESULTS	In four patients ( 33.3 % ) , the anchored stent was left indefinitely in order to treat the underlying condition .
RESULTS	There were no complications associated with deployment of the OTSC or SEMS removal .
CONCLUSIONS	Although endoscopic anchoring of fully covered SEMS with the OTSC was feasible , easy to accomplish , safe , and prevented stent migration in most cases , larger studies are needed to confirm these encouraging early findings .
CONCLUSIONS	The inject-and-resect technique was safe and efficient for OTSC and stent removal in all cases in which it was attempted .

###25548838
BACKGROUND	Botulinum toxin type A ( BTX-A ) is widely used for the clinical treatment of masseteric hypertrophy .
BACKGROUND	Until now , few reports have discussed how to prolong the duration of its effectiveness .
OBJECTIVE	This study evaluated that purposely adjusting the masticatory movements is possible of postponing the masseter muscle rehypertrophy .
METHODS	Ninety-eight patients were randomly and equally divided into 2 groups , and 35 U BTX-A per side was injected into the masseters .
METHODS	The thickness and volume of the masticatory muscles were measured by ultrasound and computerized tomography , respectively .
METHODS	Patients in Group 1 were instructed to strengthen their masticatory effort during the denervated atrophic stage of the masseter ( the interval was evaluated by real-time ultrasound monitoring ) , whereas patients in Group 2 were not given this instruction .
METHODS	When the masseter muscle began to recover , patients in both groups were instructed to reduce their chewing .
RESULTS	The duration of the masseter muscle rehypertrophy was significantly prolonged in Group 1 patients .
RESULTS	The thickness and the volume of the other masticatory muscles were significantly increased in Group 1 but were either slightly decreased or insignificantly different in Group 2 .
CONCLUSIONS	Purposely strengthening masticatory muscle movement during the denervated atrophic stage of the masseter can prolong the duration of masseter rehypertrophy .

###24612233
OBJECTIVE	The aim of this prospective randomized study was to evaluate the efficacy of estrogen in preventing intrauterine adhesions following hysteroscopic septal resection and to investigate its effect on reproductive outcome .
METHODS	After hysteroscopic septal resection , 90 women received either estrogen or placebo ( n = 45 per group ) for 30 days .
METHODS	A second-look hysteroscopy was performed after 2 months .
METHODS	All pregnancies occurring during the study period were recorded .
RESULTS	Adhesions developed in three of 43 ( 6.9 % ) patients in the control group compared to none in the estrogen group .
RESULTS	This difference was not statistically significant ( P = 0.24 ) .
RESULTS	Regarding reproductive outcome , the differences between the two groups were also not significant .
CONCLUSIONS	Estrogen treatment was not found to prevent intrauterine adhesions or improve reproductive outcome after hysteroscopic septal resection .

###25171029
BACKGROUND	A preliminary report showed that autologous blood is an effective and easily applicable technique that can control actively bleeding gastroduodenal ulcers .
BACKGROUND	The aim of this study was to test whether an endoscopic injection of autologous blood is comparable to an endoscopic injection of diluted epinephrine in controlling bleeding from gastroduodenal ulcers .
METHODS	A total of 100 patients with actively bleeding gastroduodenal ulcers were assigned randomly to either an autologous blood injection ( group A , n = 50 ) or a diluted epinephrine injection ( group B , n = 50 ) along the edges of the ulcers .
METHODS	Groups were compared for rates of initial hemostasis , rebleeding , and complications .
RESULTS	All patients initially achieved hemostasis ( 100 % ) .
RESULTS	Rebleeding occurred in four patients from group A ( 8 % ) and five patients from group B ( 10 % ) .
RESULTS	Two patients in group B developed cardiovascular complications ( arrhythmia and ischemic heart attack ) , whereas none in group A developed complications .
CONCLUSIONS	Autologous blood is effective , comparable to diluted epinephrine in achieving initial hemostasis from actively bleeding gastroduodenal ulcers , associated with an 8 % rebleeding rate , and led to no complications .

###25664775
BACKGROUND	The objective of this study was to determine the effects of the N-methyl-d-aspartate ( NMDA ) receptor antagonist , memantine ( 0 , 20 , 40mg/d ) , upon alcohol drinking and craving in heavy drinkers with or without a family history ( FH ) of alcoholism , and to explore the modulatory influence of the presence of impulsivity on these outcomes .
METHODS	Ninety-two , nontreatment-seeking , heavy drinkers received memantine or placebo for 8days .
METHODS	On the eighth day , they received a priming dose of alcohol followed by a 3-hour period of alcohol access .
RESULTS	Memantine at a dose of 20mg reduced alcohol craving but did not influence alcohol drinking .
RESULTS	No effects of FH were observed .
RESULTS	In participants with higher baseline levels of impulsivity , 40mg of memantine reduced alcohol craving but increased alcohol drinking and alcohol-induced stimulation .
CONCLUSIONS	NMDA receptor signaling may play divergent roles in mediating alcohol cue-induced craving and alcohol drinking in heavy drinkers .
CONCLUSIONS	The potential efficacy of memantine as monotherapy for alcohol use disorders may be limited by its tendency to disinhibit drinking in some individuals .

###24384954
OBJECTIVE	To explore the surgical techniques in posterolateral mini-incision total hip arthroplasty and clinical efficacy .
METHODS	A total of 94 patients ( 98 hips ) had posterolateral mini-incision total hip arthroplasty , from December 2006 to December 2008 , and were randomly divided into a posterolateral miniincision total hip arthroplasty group ( Group A ) and a conventional group of posterolateral incision for total hip arthroplasty ( Group B ) .
METHODS	Forty-nine patients ( 50 hips ) in Group A had posterolateral small incision total hip arthroplasty [ 26 males , 23 females , between 37.0 and 95.0 years ( average 68.9 years ) , body mass index ( BMI ) between 20.3 and 29.7 ( average BMI 25.4 ) ] .
METHODS	Forty-five patients ( 48 hips ) in Group B had the conventional posterolateral incision [ 27 males , 18 females , between 45.0 and 92.0 years ( average 69.7 years ) , BMI between 18.7 and 34.1 ( average BMI 26.9 ) ] .
METHODS	The incision length , blood loss , drainage , operation time , and postoperative Harris scores were compared between the 2 groups .
RESULTS	The incision length was 6.0 ~ 10.5 ( average length 7.4 ) cm , average blood loss was 387.6 ( 140.0 ~ 1000.0 ) mL , average drainage was 143.1 ( 63.0 ~ 375.0 ) mL , average blood transfusion was 77.6 ( 0 ~ 400.0 ) mL , average operation time was 84.6 ( 63.0 ~ 130.0 ) min , and vitalock abduction angle imaging after the operation was 41.6 ( averagely 38.0 ~ 57.0 ) in Group A.
RESULTS	The incision length was 15.0 ~ 23.0 ( average length 20.0 ) cm , average blood loss was 513.1 ( 210.0 ~ 1350.0 ) mL , average drainage was 152.3 ( 70.0 ~ 520.0 ) mL , average blood transfusion was 142.2 ( 0 ~ 800.0 ) mL , average operation time was 84.0 ( 71.0 ~ 115.0 ) min , and postoperative radiographic acetabular cup abduction angle was 42.3 ( 37.0 ~ 54.0 ) in Group B.
RESULTS	The follow-up showed that the prosthesis of the 2 groups was in a good position , Harris score was significantly improved with no complications after total hip arthroplasty in the 2 groups .
CONCLUSIONS	With the correct selection of indications and adept operation skills and other circumstances , posterolateral mini-incision total hip arthroplasty may do little damage to the soft tissue with a small scar on the skin .
CONCLUSIONS	The imaging evaluation after the operation and the Harris score show no difference between the 2 groups .
CONCLUSIONS	Patients are satisfied with their joint function and postoperative recovery .

###25409438
BACKGROUND	In randomised trials of medical interventions , the most reliable analysis follows the intention-to-treat ( ITT ) principle .
BACKGROUND	However , the ITT analysis requires that missing outcome data have to be imputed .
BACKGROUND	Different imputation techniques may give different results and some may lead to bias .
BACKGROUND	In anti-obesity drug trials , many data are usually missing , and the most used imputation method is last observation carried forward ( LOCF ) .
BACKGROUND	LOCF is generally considered conservative , but there are more reliable methods such as multiple imputation ( MI ) .
OBJECTIVE	To compare four different methods of handling missing data in a 60-week placebo controlled anti-obesity drug trial on topiramate .
METHODS	We compared an analysis of complete cases with datasets where missing body weight measurements had been replaced using three different imputation methods : LOCF , baseline carried forward ( BOCF ) and MI .
RESULTS	561 participants were randomised .
RESULTS	Compared to placebo , there was a significantly greater weight loss with topiramate in all analyses : 9.5 kg ( SE 1.17 ) in the complete case analysis ( N = 86 ) , 6.8 kg ( SE 0.66 ) using LOCF ( N = 561 ) , 6.4 kg ( SE 0.90 ) using MI ( N = 561 ) and 1.5 kg ( SE 0.28 ) using BOCF ( N = 561 ) .
CONCLUSIONS	The different imputation methods gave very different results .
CONCLUSIONS	Contrary to widely stated claims , LOCF did not produce a conservative ( i.e. , lower ) efficacy estimate compared to MI .
CONCLUSIONS	Also , LOCF had a lower SE than MI .

###24315475
OBJECTIVE	To investigate the effects of 80-kilovoltage ( kV ) tube voltage coronary computed tomographic angiography ( CCTA ) with a reduced amount of contrast agent on qualitative and quantitative image quality parameters and on radiation dose in patients with a body mass index ( BMI ) < 23.0 kg/m ( 2 ) .
METHODS	One hundred and twenty consecutive patients with a BMI < 23.0 kg/m ( 2 ) and a low calcium load undergoing retrospective electrocardiogram ( ECG ) - gated dual-source CCTA were randomized into two groups [ standard-tube voltage ( 120-kV ) vs. low-tube voltage ( 80-kV ) ] .
METHODS	The injection flow rate of contrast agent ( 350 mg I/mL ) was adjusted to body weight of each patient ( 4.5-5 .5 mL/s in the 120-kV group and 2.8-3 .8 mL/s in the 80-kV group ) .
METHODS	Radiation and contrast agent doses were evaluated .
METHODS	Quantitative image quality parameters and figure of merit ( FOM ) of coronary artery were evaluated .
METHODS	Each coronary segment was evaluated for image quality on a 4-point scale .
RESULTS	Compared with the 120-kV group , effective dose and amount of contrast agent in the 80-kV group were decreased by 57.8 % and 30.5 % ( effective dose :2.7 0.5 vs. 6.4 1.3 mSv ; amount of contrast agent :57.1 3.2 vs. 82.1 6.1 mL ; both p < 0.0001 ) , respectively .
RESULTS	Image noise was 22.7 2.1 HU for 120-kV images and 33.2 5.2 HU for 80-kV images ( p < 0.0001 ) .
RESULTS	Signal-to-noise ratio ( SNR ) and contrast-to-noise ratio ( CNR ) in the proximal right coronary artery ( RCA ) and left main coronary artery ( LMA ) were all lower in 80-kV than 120-kV images ( SNR in the proximal RCA : 16.5 1.8 vs. 19.4 2.8 ; SNR in the LMA : 16.3 2.0 vs. 19.6 2.7 ; CNR in the proximal RCA : 19.4 2.3 vs. 22.9 3.0 ; CNR in the LMA : 18.8 2.4 vs. 22.7 2.9 ; all p < 0.0001 ) .
RESULTS	FOM were all significantly higher in 80-kV than 120-kV images ( proximal RCA : 146.7 45.1 vs. 93.4 32.0 ; LMA : 139.1 47.2 vs. 91.6 31.1 ; all p < 0.0001 ) .
RESULTS	There was no significant difference in image quality score between the two groups ( 3.3 0.8 vs. 3.3 0.8 , p = 0.068 ) despite decreased SNR and CNR of coronary artery in the 80-kV group .
CONCLUSIONS	The 80-kV protocol significantly reduces radiation and contrast agent doses in CCTA in patients with a low BMI < 23.0 kg/m ( 2 ) and a low calcium load while maintaining image quality .

###25584002
OBJECTIVE	GVAX pancreas , granulocyte-macrophage colony-stimulating factor-secreting allogeneic pancreatic tumor cells , induces T-cell immunity to cancer antigens , including mesothelin .
OBJECTIVE	GVAX is administered with low-dose cyclophosphamide ( Cy ) to inhibit regulatory T cells .
OBJECTIVE	CRS-207 , live-attenuated Listeria monocytogenes-expressing mesothelin , induces innate and adaptive immunity .
OBJECTIVE	On the basis of preclinical synergy , we tested prime/boost vaccination with GVAX and CRS-207 in pancreatic adenocarcinoma .
METHODS	Previously treated patients with metastatic pancreatic adenocarcinoma were randomly assigned at a ratio of 2:1 to two doses of Cy/GVAX followed by four doses of CRS-207 ( arm A ) or six doses of Cy/GVAX ( arm B ) every 3 weeks .
METHODS	Stable patients were offered additional courses .
METHODS	The primary end point was overall survival ( OS ) between arms .
METHODS	Secondary end points were safety and clinical response .
RESULTS	A total of 90 patients were treated ( arm A , n = 61 ; arm B , n = 29 ) ; 97 % had received prior chemotherapy ; 51 % had received two regimens for metastatic disease .
RESULTS	Mean number of doses ( standard deviation ) administered in arms A and B were 5.5 4.5 and 3.7 2.2 , respectively .
RESULTS	The most frequent grade 3 to 4 related toxicities were transient fevers , lymphopenia , elevated liver enzymes , and fatigue .
RESULTS	OS was 6.1 months in arm A versus 3.9 months in arm B ( hazard ratio [ HR ] , 0.59 ; P = .02 ) .
RESULTS	In a prespecified per-protocol analysis of patients who received at least three doses ( two doses of Cy/GVAX plus one of CRS-207 or three of Cy/GVAX ) , OS was 9.7 versus 4.6 months ( arm A v B ; HR , 0.53 ; P = .02 ) .
RESULTS	Enhanced mesothelin-specific CD8 T-cell responses were associated with longer OS , regardless of treatment arm .
CONCLUSIONS	Heterologous prime/boost with Cy/GVAX and CRS-207 extended survival for patients with pancreatic cancer , with minimal toxicity .

###25116984
OBJECTIVE	To determine the effects of tai chi training on functional performance and walking with and without the addition of the performance of a cognitive task , in older adults living in supportive housing facilities .
METHODS	Secondary data analysis comparing a single-blind , randomized controlled trial of tai chi training with an attention-matched educational control intervention with crossover to tai chi .
METHODS	Two supportive housing facilities .
METHODS	Sixty-six men and women living in supportive housing facilities entered the study , and 57 aged 877 completed all study procedures .
METHODS	Interventions consisted of two 1-hour-long instructor-led group sessions per week for 12 weeks .
METHODS	Tai chi training consisted of movements based upon the Yang-style short form .
METHODS	Educational sessions consisted of lectures and discussions of age-related health topics .
METHODS	Subjects were tested for physical function ( Short Physical Performance Battery , SPPB ) , balance ( Berg Balance Scale , BBS ) , mobility ( timed up-and-go , TUG ) , and walking speed under normal and cognitive dual-task conditions .
RESULTS	The tai chi group exhibited greater improvement in SPPB scores ( baseline 8.12.9 , follow-up 9.02.6 ) than controls ( baseline 8.22.6 , follow-up 8.22.6 ) ( P = .005 ) .
RESULTS	Tai chi also increased normal and dual-task walking speed ( P < .001 ) yet did not affect BBS ( P = .02 ) or TUG ( P = .02 ) after accounting for multiple comparisons .
RESULTS	The dual-task cost ( percentage change ) to walking speed was unaffected .
RESULTS	After the crossover tai chi intervention , the control group improved performance in the SPPB , BBS , and TUG , and increased walking speed under normal and dual-task conditions ( P = .008 ) .
CONCLUSIONS	Tai chi training may be a safe and effective therapy to help improve physical function and dual-task walking in very old adults living in supportive housing facilities .

###25403681
OBJECTIVE	To assess the efficacy and safety of a 24-week course of abatacept in the treatment of active lupus nephritis and to assess the potential of abatacept to induce `` clinical tolerance , '' defined as sustained clinical quiescence of lupus nephritis after discontinuation of immunosuppressive therapy .
METHODS	Patients with active lupus nephritis ( n = 134 ) were enrolled in a randomized , double-blind phase II add-on trial in which they received either abatacept or placebo in conjunction with the Euro-Lupus Nephritis Trial regimen of low-dose cyclophosphamide ( CYC ) followed by azathioprine ( AZA ) .
METHODS	The primary efficacy outcome was the frequency of complete response at week 24 .
METHODS	Thereafter , patients who met either complete or partial response criteria continued blinded treatment through week 52 .
METHODS	During this phase of the study , subjects in the abatacept treatment group in whom a complete response was achieved at week 24 discontinued immunosuppressive therapy other than prednisone ( 10 mg/day ) .
RESULTS	There were no statistically significant differences between groups with respect to the primary outcome or any of the secondary outcomes , including measures of safety .
RESULTS	A complete response was achieved in 33 % of the subjects in the treatment group and in 31 % of the subjects in the control group at week 24 .
RESULTS	Fifty percent of the subjects in the treatment group who met complete response criteria and therefore discontinued immunosuppressive therapy at week 24 maintained their complete response status through week 52 .
CONCLUSIONS	The addition of abatacept to a regimen of CYC followed by AZA did not improve the outcome of lupus nephritis at either 24 or 52 weeks .
CONCLUSIONS	No worrisome safety signals were encountered .

###24633297
OBJECTIVE	The aim of this study was to evaluate the effects of umbilical cord milking ( UCM ) on the need for packed red blood cell ( PRBC ) transfusion and hematologic and hemodynamic parameters in very-low-birth-weight infants .
METHODS	The infants were randomized into 2 groups : group 1 ( UCM ) and group 2 ( control ) .
METHODS	The primary outcome was the number of PRBC transfusions during the first 35 days of life .
METHODS	The secondary outcome measures were the hemodynamic variables during the first 24 hours of life .
RESULTS	A total of 44 infants were included with 22 infants in each group .
RESULTS	Two of 21 infants in group 1 and 4 of 21 infants in group 2 received transfusion in the first 3 days of life ( P = 0.384 ) .
RESULTS	The number and volume of PRBC transfusions were similar in both groups .
RESULTS	However , the levels of hemoglobin ( Hb ) at the first and 24th hour of life were significantly higher in group 1 .
RESULTS	Phlebotomy volume was found as a statistically significant risk factor for the need for PRBC transfusion ( P = 0.005 ) .
CONCLUSIONS	UCM in delivery room results in a higher Hb level in the first day of life .
CONCLUSIONS	In these groups of infants , phlebotomy losses may impact the transfusion need .

###24877242
OBJECTIVE	Previous studies comparing endoscopic ultrasound-guided fine-needle aspiration ( EUS-FNA ) results with different gauge needles have all been carried out with the stylet in place and show no clear advantage to the larger 22-G needle .
OBJECTIVE	Similar data for stylet-free EUS-FNA ( SF-EUS-FNA ) are unavailable .
OBJECTIVE	The aim of the present study was to determine whether diagnostic yield and specimen adequacy is superior with the 22-G needle as compared to the 25-G needle .
METHODS	All patients 18 years referred for solid-lesion EUS-FNA were eligible .
METHODS	Patients with suspected diagnosis of lymphoma , gastrointestinal stromal tumor , sarcoidosis , significant coagulopathy ( international normalized ratio > 1.5 or platelets < 50000/mm ( 3 ) ) , use of clopidogrel within 7 days of EUS , and pregnancy were excluded .
METHODS	The two needles were compared regarding diagnostic yield , sample adequacy , bloodiness , ease of puncture , visibility , number of passes , failures , and complications .
RESULTS	One hundred and twenty consecutive patients were included and 126 lesions were sampled .
RESULTS	Sensitivity , specificity , positive predictive value and negative predictive value for the 22-G SF-EUS-FNA were 83 % , 100 % , 100 % and 56 % , respectively , and for the 25-G SF-EUS-FNA were 88.8 % , 100 % , 100 % and 76.5 % , respectively ( P = NS ) .
RESULTS	There were no significant differences between the 22-G and the 25-G FNA needles in sample adequacy , bloodiness , ease of puncture , FNA failure , visibility , number of passes and complications ; and no significant differences between either needle were found in relation to lesion site .
CONCLUSIONS	For SF-EUS-FNA , the larger 22-G needle offers no advantage over the smaller 25-G needle .

###24406355
BACKGROUND	This study was designed with the aim of defining a new surgical procedure for varicose veins and for comparison with classic crossectomy in terms of reducing the recurrence rate of varicose veins .
METHODS	Double-blind randomized clinical trial .
METHODS	For easy access , we selected 150 patients who came to the Phlebology Consultation Unit meeting inclusion criteria .
METHODS	With their informed consent , they were included in a study group using random table numbers .
METHODS	Group 1 : ( CS ) Classic saphenectomy , 75 patients .
METHODS	Group 2 : ( HCWVS ) High crossectomy without vascular sectioning .
METHODS	Both groups were monitorised at 12 and 24 months by Eco-Doppler study .
RESULTS	The incidence of varicose vein recurrence at 12 month follow-up was 69.3 % in the group of patients undergoing CS , while in the group receiving HCWVS it was 29.3 % ( p < 0.0001 ) .
RESULTS	These differences , though minor , remained statistically significant at 24 months of evolution ( 76 % vs. 48 % , p = 0.0004 ) .
RESULTS	The most common recurrence type was type I , with statistically significant differences at 12 and 24 months .
CONCLUSIONS	We believe that saphenectomy with crossectomy without vascular sectioning is the appropriate procedure to treat varicose veins , reducing type 1 or reticular relapse rate and maintaining the principles of classic surgery to reduce type 2 or truncular recurrence rate .
CONCLUSIONS	This technique should be implemented with procedures based on saphenous sclerosis with foam art the saphenous femoral junction , in order to assess the recurrence rate of type 2 or truncular varicose veins .

###25020152
OBJECTIVE	A group-based eating disorder prevention program wherein young women explore the costs of pursuing the thin ideal reduces eating disorder risk factors and symptoms .
OBJECTIVE	However , it can be challenging to identify school clinicians to effectively deliver the intervention .
OBJECTIVE	The present study compares the effects of a new Internet-based version of this prevention program , which could facilitate dissemination , to the group-based program and to educational video and educational brochure control conditions at 1 - and 2-year follow-up .
METHODS	Female college students with body dissatisfaction ( n = 107 ; M age = 21.6 , SD = 6.6 ) were randomized to these 4 conditions .
RESULTS	Internet participants showed reductions in eating disorder risk factors and symptoms relative to the 2 control conditions at 1 - and 2-year follow-up ( M - d = .34 and .17 , respectively ) , but the effects were smaller than parallel comparisons for the group participants ( M - d = .48 and .43 , respectively ) .
RESULTS	Yet the Internet intervention produced large weight gain prevention effects relative to the 2 control conditions at 1 - and 2-year follow-up ( M - d = .80 and .73 , respectively ) , which were larger than the parallel effects for the group intervention ( M - d = .19 and .47 , respectively ) .
CONCLUSIONS	Although the effects for the Internet versus group intervention were similar at posttest , results suggest that the effects faded more quickly for the Internet intervention .
CONCLUSIONS	However , the Internet intervention produced large weight gain prevention effects , implying that it might be useful for simultaneously preventing eating disordered behavior and unhealthy weight gain .

###25274710
BACKGROUND	Financial incentives and peer networks could be delivered through eHealth technologies to encourage older adults to walk more .
METHODS	We conducted a 24-week randomized trial in which 92 older adults with a computer and Internet access received a pedometer , daily walking goals , and weekly feedback on goal achievement .
METHODS	Participants were randomized to weekly feedback only ( Comparison ) , entry into a lottery with potential to earn up to $ 200 each week walking goals were met ( Financial Incentive ) , linkage to four other participants through an online message board ( Peer Network ) , or both interventions ( Combined ) .
METHODS	Main outcomes were the proportion of days walking goals were met during the 16-week intervention and 8-week follow-up .
METHODS	We conducted a content analysis of messages posted by Peer Network and Combined arm participants .
RESULTS	During the 16-week intervention , there were no differences in the proportion of days walking goals were met in the Financial Incentive ( 39.7 % ; p = .78 ) , Peer Network ( 24.9 % ; p = .08 ) , and Combined ( 36.0 % ; p = .77 ) arms compared with the Comparison arm ( 36.0 % ) .
RESULTS	During 8 weeks of follow-up , the proportion of days walking goals were met was lower in the Peer Network arm ( 18.7 % ; p = .025 ) but not in the Financial Incentive ( 29.3 % ; p = .50 ) or Combined ( 24.8 % ; p = .37 ) arms , relative to the Comparison arm ( 34.5 % ) .
RESULTS	Messages posted by participants focused on barriers to walking and provision of social support .
CONCLUSIONS	Financial incentives and peer networks delivered through eHealth technologies did not result in older adults walking more .

###24919430
BACKGROUND	Children can find anaesthesia induction especially distressing and postoperative psychological and physical morbidity are common .
BACKGROUND	Preparation programmes for general anaesthesia ( GA ) are highly effective in reducing this distress .
BACKGROUND	A Phase II study has already verified the effectiveness of a prototype preoperative GA-coping computer game to help children cope with induction in a dental GA setting .
BACKGROUND	The biggest patient users of pediatric GA services in the UK are children who need to have teeth removed ( estimated to be 100,000 yearly ) .
BACKGROUND	Tooth decay is the most common disease in children worldwide .
BACKGROUND	This study is a Phase III randomized controlled trial ( RCT ) and will evaluate the effectiveness of the new internet version of this game .
METHODS	The Phase III RCT will use a double-blind three-armed design .
METHODS	The clinical trial will recruit up to 210 children and will compare the web-based game against standard care and another non-medical game .
METHODS	At least 53 patients in each group will be required for 90 % statistical power .
METHODS	Distress will be assessed through an evaluation of the child 's behaviour during the visit and later parental reports of physical and psychological morbidity .
METHODS	The satisfaction of parents and children will be measured ; the mode of usage of the web-based game will be automatically recorded and the impact on the service ( for example , recovery time and throughput ) will be reported.The Phase III study primary outcome will measure : ( 1 ) patient experience : acceptance of anaesthetic induction , child cooperation and distress , reduction of peri - and postoperative morbidity , child and family satisfaction , and ( 2 ) service improvement : anaesthetic time and improvement in throughput .
METHODS	Measures will be administered at baseline , at the time of the GA treatment visit , and at 48hours and one week postoperatively .
CONCLUSIONS	This study aims to determine the effectiveness of an online GA-coping game for children and families undergoing tooth extraction under GA. .
BACKGROUND	ISRCTN18265148 ( registered 24 November 2013 ) .

###24602760
BACKGROUND	Patients with advanced-stage , low-tumour-burden follicular lymphoma have conventionally undergone watchful waiting until disease progression .
BACKGROUND	We assessed whether rituximab use could delay the need for chemotherapy or radiotherapy compared with watchful waiting and the effect of this strategy on quality of life ( QoL ) .
METHODS	Asymptomatic patients ( aged 18 years ) with low-tumour-burden follicular lymphoma ( grades 1 , 2 , and 3a ) were randomly assigned centrally ( 1:1:1 ) , by the minimisation approach stratified by institution , grade , stage , and age , to watchful waiting , rituximab 375 mg/m ( 2 ) weekly for 4 weeks ( rituximab induction ) , or rituximab induction followed by a maintenance schedule of 12 further infusions given at 2-monthly intervals for 2 years ( maintenance rituximab ) .
METHODS	On Sept 30 , 2007 , recruitment into the rituximab induction group was closed and the study was amended to a two-arm study .
METHODS	The primary endpoints were time to start of new treatment and QoL at month 7 ( ie , 6 months after completion of rituximab induction ) .
METHODS	All randomly assigned patients were included in the analysis of time to start of new treatment on an intention-to-treat basis .
METHODS	The main study is now completed and is in long-term follow-up .
METHODS	The study is registered with ClinicalTrials.gov , NCT00112931 .
RESULTS	Between Oct 15 , 2004 , and March 25 , 2009 , 379 patients from 118 centres in the UK , Australia , New Zealand , Turkey , and Poland were randomly assigned to watchful waiting or maintenance rituximab .
RESULTS	84 patients were recruited to the rituximab induction group before it was closed early .
RESULTS	There was a significant difference in the time to start of new treatment , with 46 % ( 95 % CI 39-53 ) of patients in the watchful waiting group not needing treatment at 3 years compared with 88 % ( 83-92 ) in the maintenance rituximab group ( hazard ratio [ HR ] 021 , 95 % CI 014-031 ; p < 00001 ) .
RESULTS	78 % ( 95 % CI 69-87 ) of patients in the rituximab induction group did not need treatment at 3 years , which was significantly more than in the watchful waiting group ( HR 035 , 95 % CI 022-056 ; p < 00001 ) , but no different compared with the maintenance rituximab group ( 075 , 041-134 ; p = 033 ) .
RESULTS	Compared with the watchful waiting group , patients in the maintenance rituximab group had significant improvements in the Mental Adjustment to Cancer scale score ( p = 00004 ) , and Illness Coping Style score ( p = 00012 ) between baseline and month 7 .
RESULTS	Patients in the rituximab induction group did not show improvements in their QoL compared with the watchful waiting group .
RESULTS	There were 18 serious adverse events reported in the rituximab groups ( four in the rituximab induction group and 14 in the maintenance rituximab group ) , 12 of which were grade 3 or 4 ( five infections , three allergic reactions , and four cases of neutropenia ) , all of which fully resolved .
CONCLUSIONS	Rituximab monotherapy should be considered as a treatment option for patients with asymptomatic , advanced-stage , low-tumour-burden follicular lymphoma .
BACKGROUND	Cancer Research UK , Lymphoma Research Trust , Lymphoma Association , and Roche .

###24861034
BACKGROUND	Narrow-band imaging ( NBI ) endoscopy improves the detection of intestinal metaplasia .
BACKGROUND	However , strategies to improve the visibility and diagnostic performance of NBI should be sought , as endoscopic views are often obscured by the presence of mucus .
OBJECTIVE	To compare the visibility and diagnostic performance of NBI endoscopy according to pronase premedication in patients with precancerous conditions of the stomach .
METHODS	Consecutive outpatients with a previous diagnosis of precancerous condition of the stomach were invited to undergo a surveillance NBI endoscopy between June and December 2012 .
METHODS	Enrolled subjects were randomly assigned to pronase or control groups before NBI endoscopy .
METHODS	The visibility score and diagnostic performance of NBI endoscopy were compared between the two groups .
RESULTS	Patients ' endoscopic and histopathological characteristics were similar between the two groups .
RESULTS	Visibility score in the proximal part of the stomach and satisfaction score of the endoscopist were significantly higher in the pronase group than in the control group ( p = 0.014 and p = 0.034 , respectively ) .
RESULTS	The diagnostic performance of NBI endoscopy to detect intestinal metaplasia was not different in either group ( both p > 0.1 ) .
RESULTS	However , the negative predictive value of NBI endoscopy was much improved over that of white light endoscopy only in the pronase group ( p = 0.013 ) .
CONCLUSIONS	Pronase premedication increased the visibility of the proximal part of the stomach and the satisfaction score during NBI endoscopy .
CONCLUSIONS	Furthermore , negative predictive value of NBI endoscopy was much improved compared with that of white light endoscopy after pronase premedication .

###26314532
BACKGROUND	The incidence , predictors , and prognostic impact of post-discharge bleeding ( PDB ) after percutaneous coronary intervention ( PCI ) with drug-eluting stent ( DES ) implantation are unclear .
OBJECTIVE	This study sought to characterize the determinants and consequences of PDB after PCI .
METHODS	The prospective ADAPT-DES ( Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents ) study was used to determine the incidence and predictors of clinically relevant bleeding events occurring within 2 years after hospital discharge .
METHODS	The effect of PDB on subsequent 2-year all-cause mortality was estimated by time-adjusted Cox proportional hazards regression .
RESULTS	Among 8,582 `` all-comers '' who underwent successful PCI with DES in the ADAPT-DES study , PDB occurred in 535 of 8,577 hospital survivors ( 6.2 % ) at a median time of 300 days ( interquartile range : 130 to 509 days ) post-discharge .
RESULTS	Gastrointestinal bleeding ( 61.7 % ) was the most frequent source of PDB .
RESULTS	Predictors of PDB included older age , lower baseline hemoglobin , lower platelet reactivity on clopidogrel , and use of chronic oral anticoagulation therapy .
RESULTS	PDB was associated with higher crude rates of all-cause mortality ( 13.0 % vs. 3.2 % ; p < 0.0001 ) .
RESULTS	Following multivariable adjustment , PDB was strongly associated with 2-year mortality ( hazard ratio [ HR ] : 5.03 ; p < 0.0001 ) , with an effect size greater than that of post-discharge myocardial infarction ( PDMI ) ( HR : 1.92 ; p = 0.009 ) .
CONCLUSIONS	After successful PCI with DES in an unrestricted patient population , PDB is not uncommon and has a strong relationship with subsequent all-cause mortality , greater that that associated with PDMI .
CONCLUSIONS	Efforts to reduce PDB may further improve prognosis after successful DES implantation .
CONCLUSIONS	( Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents [ ADAPT-DES ] ; NCT00638794 ) .

###25683105
OBJECTIVE	Determine the association of children 's susceptibility to large food portion sizes with appetite regulation and obesity .
METHODS	Normal-weight and obese non-Hispanic black children ( n = 100 ) aged 5-6 years were observed in four dinner conditions of varying portion size ; portions of all foods ( except milk ) offered were : 100 % ( 677 kcal ) , 150 % ( 1015 kcal ) , 200 % ( 1353 kcal ) , or 250 % ( 1691 kcal ) of those in the reference condition ( 100 % ) .
METHODS	Condition order was randomly assigned to 2-4 children who ate together at each meal .
METHODS	Child height and weight were measured and caregiver reports of child appetite were obtained .
METHODS	Hierarchical growth curve models were used to estimate associations of meal energy intake with portion size condition , child weight status , and appetite regulation traits , controlling for demographics .
RESULTS	Total energy intake increased across conditions of increasing food portion size ( P < 0.001 ) .
RESULTS	The effect of portion size condition on total energy intake varied with food responsiveness ( P = 0.05 ) and satiety responsiveness ( P < 0.05 ) , but not weight status ( P = 0.682 ) .
RESULTS	Children with lower satiety responsiveness and greater food responsiveness showed greater increases in meal energy across conditions .
CONCLUSIONS	Children with poorer appetite regulation may be more vulnerable to obesogenic dietary environments offering large food portions than other children .

###25579875
OBJECTIVE	Compression therapy is highly effective in the treatment of post-thrombotic syndrome and venous leg ulcer .
OBJECTIVE	On average , 50-60 % of the patients cooperate with compression therapy .
OBJECTIVE	Therefore , it is necessary to improve the user-friendliness .
OBJECTIVE	This prospective study investigated whether the use of donning devices can contribute to improving user-friendliness .
METHODS	Forty patients aged > 65 years with severe chronic venous insufficiency ( CVI ; C4-C6 ) successively donned compression stockings in a randomized order : one 40mmHg ( CS40 ) or two superimposed 20mmHg ( CS20 +20 ) , each with open toe ( CS-o-t ) and closed toe ( CS-c-t ) , using donning devices ( three foot slips for CS-o-t ; two foot slips and three frames for CS-c-t ) .
METHODS	The study endpoint was that the stocking was completely donned and correctly positioned on the patient 's leg .
METHODS	The success rate and its association with age , sex , first time versus second time user , body mass index , abdominal circumference , ability to reach the forefoot with the hand , and hand grip strength were analyzed .
METHODS	Additionally , subjective evaluation by the patients was performed .
RESULTS	Without donning devices , success with CS40-c-t was 60 % ( 24/40 patients ) and with CS20 +20 - c-t 70 % ( 28/40 patients ) ( p = .220 ) .
RESULTS	Using donning devices increased success rates significantly .
RESULTS	With CS40-o-t the success rate was 88 % ( 35/40 patients ; p = .001 ) and with CS40-c-t it was 90 % ( 36/40 patients ; p = .002 ) .
RESULTS	With CS20 +20 - o-t and CS20 +20 - c-t , the success rate was 88 % ( 35/40 patients ; p = .016 ) .
RESULTS	The proportion of patients who successfully used either CS40 or CS20 +20 increased from 73 % to 93 % .
RESULTS	Relevant for the patients ' success was the ability to reach the forefoot with the hand , and hand grip strength .
RESULTS	Subjectively , donning with a device was rated significantly better than without .
CONCLUSIONS	Donning devices significantly improve the ability of elderly patients with CVI to don compression stockings successfully .
CONCLUSIONS	However , there are differences in user-friendliness among the devices .

###24450727
BACKGROUND	In August 2010 , the U.S. Food and Drug Administration issued draft guidelines for developing antibiotics for treating acute bacterial skin and skin structure infections ( ABSSSI ) , with the outcome measure of such treatment relying primarily on the cessation of spread or on the decrease in size of skin lesions at 48-72h after the initiation of such treatment .
BACKGROUND	In 2012 , the Foundation for the National Institutes of Health proposed an interim outcome measure defined as a reduction in lesion size by 20 % at a 48-72h examination .
BACKGROUND	These recent changes make it necessary to identify reliable methods for measuring the lesions in acute infections of the skin .
METHODS	In the first study of the Efficacy and Safety of 6-day Oral Tedizolid in Acute Bacterial Skin and Skin Structure Infections vs. 10-day Oral Linezolid Therapy ( ESTABLISH-1 ) , the sizes of ABSSSI lesions were evaluated with the two methodologies of : ( 1 ) Digital planimetry ( DP ) of photographed lesions , and ( 2 ) a ruler technique ( RT ) with measurement of the longest head-to-toe length and greatest perpendicular width of lesions , to compare the respective response rates of lesions to the two antimicrobial regimens in the study .
RESULTS	The RT method and DP showed similar percentages of subjects in which treatment stopped the spread of ABSSSI lesions ( 93.2 % vs. 94.2 % , respectively ) but showed less agreement for a reduction in lesion size , of 20 % ( 87.7 % vs. 62.0 % , respectively ) across all categories of lesions ( cellulitis/erysipelas , major cutaneous abscess , and acute wound infection ) at 48-72h after the initiation of treatment .
CONCLUSIONS	The results of the ESTABLISH-1 study show that both the RT method and DP are consistent and reliable techniques for measuring the sizes of ABSSSI lesions .
CONCLUSIONS	Ultimately , changes in lesion size , rather than the absolute value of lesion size , will be used to assess the outcomes of treatment for ABSSSI in clinical research .

###24377531
BACKGROUND	Goshajinkigan ( GJG ) is used for the treatment of several neurological symptoms .
BACKGROUND	We investigated the efficacy of GJG and mecobalamin ( B12 ) against neurotoxicity associated with docetaxel ( DOC ) in breast cancer patients .
METHODS	Sixty breast cancer patients were treated with DOC .
METHODS	Thirty-three patients ( GJG group ) received oral administration of 7.5 g/day GJG and 27 patients ( B12 group ) received oral administration of 1500 g/day B12 .
METHODS	Neuropathy was evaluated according to DEB-NTC ( Neurotoxicity Criteria of Debiopharm ) , Common Terminology Criteria for Adverse Events ( NCI-CTC ) ver .
METHODS	3.0 , and a visual analogue scale ( VAS ) .
METHODS	This study employed a randomized open design .
RESULTS	The incidence of neuropathy was 39.3 % in the GJG group , and 88.9 % in the B12 group ( p < 0.01 ) .
RESULTS	In the GJG group , grade 1 DEB-NTC was observed in 2 cases , grade 2 in 5 cases and grade 3 in 5 cases .
RESULTS	Grade 1 NCI-CTC was observed in 7 cases , grade 2 in 6 cases , and VAS was 2.7 2.2 .
RESULTS	In the B12 group , grades 1 , 2 and 3 DEB-NTC were observed in one case , 12 cases and 12 cases , respectively ; and grades 1 , 2 and 3 NCI-CTC were observed in 11 cases , 12 cases and one case , and VAS was 4.9 2.4 .
CONCLUSIONS	Concomitant administration of GJG is useful in preventing neuropathy in breast cancer patients treated with a DOC regimen .

###26436208
BACKGROUND	Remote ischemic preconditioning ( RIPC ) is reported to reduce biomarkers of ischemic and reperfusion injury in patients undergoing cardiac surgery , but uncertainty about clinical outcomes remains .
METHODS	We conducted a prospective , double-blind , multicenter , randomized , controlled trial involving adults who were scheduled for elective cardiac surgery requiring cardiopulmonary bypass under total anesthesia with intravenous propofol .
METHODS	The trial compared upper-limb RIPC with a sham intervention .
METHODS	The primary end point was a composite of death , myocardial infarction , stroke , or acute renal failure up to the time of hospital discharge .
METHODS	Secondary end points included the occurrence of any individual component of the primary end point by day 90 .
RESULTS	A total of 1403 patients underwent randomization .
RESULTS	The full analysis set comprised 1385 patients ( 692 in the RIPC group and 693 in the sham-RIPC group ) .
RESULTS	There was no significant between-group difference in the rate of the composite primary end point ( 99 patients [ 14.3 % ] in the RIPC group and 101 [ 14.6 % ] in the sham-RIPC group , P = 0.89 ) or of any of the individual components : death ( 9 patients [ 1.3 % ] and 4 [ 0.6 % ] , respectively ; P = 0.21 ) , myocardial infarction ( 47 [ 6.8 % ] and 63 [ 9.1 % ] , P = 0.12 ) , stroke ( 14 [ 2.0 % ] and 15 [ 2.2 % ] , P = 0.79 ) , and acute renal failure ( 42 [ 6.1 % ] and 35 [ 5.1 % ] , P = 0.45 ) .
RESULTS	The results were similar in the per-protocol analysis .
RESULTS	No treatment effect was found in any subgroup analysis .
RESULTS	No significant differences between the RIPC group and the sham-RIPC group were seen in the level of troponin release , the duration of mechanical ventilation , the length of stay in the intensive care unit or the hospital , new onset of atrial fibrillation , and the incidence of postoperative delirium .
RESULTS	No RIPC-related adverse events were observed .
CONCLUSIONS	Upper-limb RIPC performed while patients were under propofol-induced anesthesia did not show a relevant benefit among patients undergoing elective cardiac surgery .
CONCLUSIONS	( Funded by the German Research Foundation ; RIPHeart ClinicalTrials.gov number , NCT01067703 . )

###24528569
BACKGROUND	An estimated 366 million people are living with diabetes worldwide and it is predicted that its prevalence will increase to 552 million by 2030 .
BACKGROUND	Management of this disease and its complications is a challenge for many countries .
BACKGROUND	Optimal glycaemic control is necessary to minimize complications , but less than 70 % of diabetic patients achieve target levels of blood glucose , partly due to poor access to qualified health care providers .
BACKGROUND	Telemedicine has the potential to improve access to health care , especially for rural and remote residents .
BACKGROUND	Video teleconsultation , a real-time ( or synchronous ) mode of telemedicine , is gaining more popularity around the world through recent improvements in digital telecommunications .
BACKGROUND	If video consultation is to be offered as an alternative to face-to-face consultation in diabetes assessment and management , then it is important to demonstrate that this can be achieved without loss of clinical fidelity .
BACKGROUND	This paper describes the protocol of a randomised controlled trail for assessing the reliability of remote video consultation for people with diabetes .
METHODS	A total of 160 people with diabetes will be randomised into either a Telemedicine or a Reference group .
METHODS	Participants in the Reference group will receive two sequential face-to-face consultations whereas in the Telemedicine group one consultation will be conducted face-to-face and the other via videoconference .
METHODS	The primary outcome measure will be a change in the patient 's medication .
METHODS	Secondary outcome measures will be findings in physical examination , detecting complications , and patient satisfaction .
METHODS	A difference of less than 20 % in the aggregated level of agreement between the two study groups will be used to identify if videoconference is non-inferior to traditional mode of clinical care ( face-to-face ) .
CONCLUSIONS	Despite rapid growth in application of telemedicine in a variety of medical specialties , little is known about the reliability of videoconferencing for remote consultation of people with diabetes .
CONCLUSIONS	Results of this proposed study will provide evidence of the reliability of specialist consultation offered by videoconference for people with diabetes .
BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12612000315819 .

###25091615
BACKGROUND	The relationship of hormones adiponectin , leptin and tumor necrosis factor-alpha in adipose tissue on the atherogenic process is one of the most promising models in preventive medicine .
BACKGROUND	The numerous tests performed to identify the effect of exercise on these hormones have not been clear on the type of exercise routine and physical effort calculated to contribute to changing plasma concentrations in obese women .
OBJECTIVE	Analyze controlledcardiovascular exercise effect on serum level of adiponectin , leptin , and tumournecrosis factor-alpha in obese young women .
METHODS	A simple blind clinical essay .
METHODS	The intervention covered a 10-week controlled , cardiovascular exercise program by 34 women ( cases n = 17 , controls n = 17 ) with a body mass index > 27kg/m ( 2 ) .
METHODS	Molecular analysis was performed by immune-fluorescence .
RESULTS	Following the intervention , cases and controls means were as follows : adiponectin 19.0 vs. 12.2 / ml ( P = .008 ) ; leptin 20.0 vs. 28.0 / L ( P = .02 ) ; and tumour necrosis factor-alpha 4.7 vs. 5.1 pg/ml ( P = .05 ) .
CONCLUSIONS	The established exercise ( 5 sessions a week of exercise of 40min each for 10 weeks with a heart rate reserve of 40 to 80 % ) improved plasma concentrations of these hormones in the expected direction .
CONCLUSIONS	This finding highlights an unpublished amount of exercise , controlled by the reserve cardiac frequency that might contribute the cardiovascular and metabolic protection to obese women .

###25024657
OBJECTIVE	To determine the feasibility and pilot a sleep education program in New Zealand high school students .
METHODS	A parallel , two-arm randomized controlled pilot trial was conducted .
METHODS	High school students ( 13 to 16 years ) were randomly allocated to either a classroom-based sleep education program intervention ( n = 15 ) or to a usual curriculum control group ( n = 14 ) .
METHODS	The sleep education program involved four 50-minute classroom-based education sessions with interactive groups .
METHODS	Students completed a 7-day sleep diary , a sleep questionnaire ( including sleep hygiene , knowledge and problems ) at baseline , post-intervention ( 4 weeks ) and 10 weeks follow-up .
RESULTS	An overall treatment effect was observed for weekend sleep duration ( F 1,24 = 5.21 , p = 0.03 ) .
RESULTS	Participants in the intervention group slept longer during weekend nights at 5 weeks ( 1:37 h : min , p = 0.01 ) and 10 weeks : ( 1:32 h : min , p = 0.03 ) compared to those in the control group .
RESULTS	No differences were found between groups for sleep duration on weekday nights .
RESULTS	No significant differences were observed between groups for any of the secondary outcomes ( sleep hygiene , sleep problems , or sleep knowledge ) .
CONCLUSIONS	A sleep education program appears to increase weekend sleep duration in the short term .
CONCLUSIONS	Although this program was feasible , most schools are under time and resource pressure , thus alternative methods of delivery should be assessed for feasibility and efficacy .
CONCLUSIONS	Larger trials of longer duration are needed to confirm these findings and determine the sustained effect of sleep education on sleep behavior and its impact on health and psychosocial outcomes .
CONCLUSIONS	A commentary on this article appears in this issue on page 793 .

###24569459
BACKGROUND	X-linked hypophosphatemia ( XLH ) is the most common heritable form of rickets and osteomalacia .
BACKGROUND	XLH-associated mutations in phosphate-regulating endopeptidase ( PHEX ) result in elevated serum FGF23 , decreased renal phosphate reabsorption , and low serum concentrations of phosphate ( inorganic phosphorus , Pi ) and 1,25-dihydroxyvitamin D [ 1,25 ( OH ) 2D ] .
BACKGROUND	KRN23 is a human anti-FGF23 antibody developed as a potential treatment for XLH .
BACKGROUND	Here , we have assessed the safety , tolerability , pharmacokinetics ( PK ) , pharmacodynamics ( PD ) , and immunogenicity of KRN23 following a single i.v. or s.c. dose of KRN23 in adults with XLH .
METHODS	Thirty-eight XLH patients were randomized to receive a single dose of KRN23 ( 0.003-0 .3 mg/kg i.v. or 0.1-1 mg/kg s.c. ) or placebo .
METHODS	PK , PD , immunogenicity , safety , and tolerability were assessed for up to 50 days .
RESULTS	KRN23 significantly increased the maximum renal tubular threshold for phosphate reabsorption ( TmP/GFR ) , serum Pi , and 1,25 ( OH ) 2D compared with that of placebo ( P < 0.01 ) .
RESULTS	The maximum serum Pi concentration occurred later following s.c. dosing ( 8-15 days ) compared with that seen with i.v. dosing ( 0.5-4 days ) .
RESULTS	The effect duration was dose related and persisted longer in patients who received s.c. administration .
RESULTS	Changes from baseline in TmP/GFR , serum Pi , and serum 1,25 ( OH ) 2D correlated with serum KRN23 concentrations .
RESULTS	The mean t1/2 of KRN23 was 8-12 days after i.v. administration and 13-19 days after s.c. administration .
RESULTS	Patients did not exhibit increased nephrocalcinosis or develop hypercalciuria , hypercalcemia , anti-KRN23 antibodies , or elevated serum parathyroid hormone ( PTH ) or creatinine .
CONCLUSIONS	KRN23 increased TmP/GFR , serum Pi , and serum 1,25 ( OH ) 2D .
CONCLUSIONS	The positive effect of KR23 on serum Pi and its favorable safety profile suggest utility for KRN23 in XLH patients .
CONCLUSIONS	Trial registration .
CONCLUSIONS	Clinicaltrials.gov NCT00830674 .
CONCLUSIONS	Funding .
CONCLUSIONS	Kyowa Hakko Kirin Pharma , Inc. .

###24787471
BACKGROUND	The PREDIMED ( Prevencin con Dieta Mediterrnea ) randomized primary prevention trial showed that a Mediterranean diet enriched with either extravirgin olive oil or mixed nuts reduces the incidence of stroke , myocardial infarction , and cardiovascular mortality .
BACKGROUND	We assessed the effect of these diets on the incidence of atrial fibrillation in the PREDIMED trial .
RESULTS	Participants were randomly assigned to 1 of 3 diets : Mediterranean diet supplemented with extravirgin olive oil , Mediterranean diet supplemented with mixed nuts , or advice to follow a low-fat diet ( control group ) .
RESULTS	Incident atrial fibrillation was adjudicated during follow-up by an events committee blinded to dietary group allocation .
RESULTS	Among 6705 participants without prevalent atrial fibrillation at randomization , we observed 72 new cases of atrial fibrillation in the Mediterranean diet with extravirgin olive oil group , 82 in the Mediterranean diet with mixed nuts group , and 92 in the control group after median follow-up of 4.7 years .
RESULTS	The Mediterranean diet with extravirgin olive oil significantly reduced the risk of atrial fibrillation ( hazard ratio , 0.62 ; 95 % confidence interval , 0.45-0 .85 compared with the control group ) .
RESULTS	No effect was found for the Mediterranean diet with nuts ( hazard ratio , 0.89 ; 95 % confidence interval , 0.65-1 .20 ) .
CONCLUSIONS	In the absence of proven interventions for the primary prevention of atrial fibrillation , this post hoc analysis of the PREDIMED trial suggests that extravirgin olive oil in the context of a Mediterranean dietary pattern may reduce the risk of atrial fibrillation .
BACKGROUND	http://www.controlled-trials.com .
BACKGROUND	Unique identifier : ISRCTN35739639 .

###25555856
OBJECTIVE	To evaluate the analgesic effect of music and audiobooks in children undergoing major surgical procedures when compared to a control ( silence ) group .
METHODS	The study was a prospective and randomized trial .
METHODS	Children undergoing major surgeries were randomized to one of the three groups : music , audiobook or control ( silence ) .
METHODS	The primary outcome was the pain burden reduction by two treatments within 48h postoperatively .
METHODS	Pain burden was measured using the area under the pain scale versus the 30min interval for each treatment .
RESULTS	60 patients were recruited and 56 completed the study .
RESULTS	Pain burden was reduced in the music and audiobook groups compared to control , median ( IQR ) of -60 ( -90 to 0 ) , -45 ( -90 to 0 ) and 0 ( -30 to 90 ) ( minpain score ) , respectively , P = 0.04 .
RESULTS	A linear regression analysis demonstrated an independent group effect on pain reduction even after adjusting for the mean pain scores recorded at the beginning of the treatment , slope of regression line -56.824 goodness of fit r ( 2 ) = 0.25 and slope significantly different from 0 ( P = 0.02 ) .
CONCLUSIONS	Audio therapy is an efficacious adjunct method to decrease post-surgical pain in children undergoing major surgeries .
CONCLUSIONS	Audio therapy should be considered as an important strategy to minimize pain in children undergoing major surgery .

###25332324
BACKGROUND	Low birth weight ( LBW ) is an important public health problem in undernourished populations .
OBJECTIVE	We tested whether improving women 's dietary micronutrient quality before conception and throughout pregnancy increases birth weight in a high-risk Indian population .
METHODS	The study was a nonblinded , individually randomized controlled trial .
METHODS	The intervention was a daily snack made from green leafy vegetables , fruit , and milk ( treatment group ) or low-micronutrient vegetables ( potato and onion ) ( control group ) from 90 d before pregnancy until delivery in addition to the usual diet .
METHODS	Treatment snacks contained 0.69 MJ of energy ( controls : 0.37 MJ ) and 10-23 % of WHO Reference Nutrient Intakes of - carotene , riboflavin , folate , vitamin B-12 , calcium , and iron ( controls : 0-7 % ) .
METHODS	The primary outcome was birth weight .
RESULTS	Of 6513 women randomly assigned , 2291 women became pregnant , 1962 women delivered live singleton newborns , and 1360 newborns were measured .
RESULTS	In an intention-to-treat analysis , there was no overall increase in birth weight in the treatment group ( +26 g ; 95 % CI : -15 , 68 g ; P = 0.22 ) .
RESULTS	There was an interaction ( P < 0.001 ) between the allocation group and maternal prepregnant body mass index ( BMI ; in kg/m ( 2 ) ) [ birth-weight effect : -23 , +34 , and +96 g in lowest ( < 18.6 ) , middle ( 18.6-21 .8 ) , and highest ( > 21.8 ) thirds of BMI , respectively ] .
RESULTS	In 1094 newborns whose mothers started supplementation 90 d before pregnancy ( per-protocol analysis ) , birth weight was higher in the treatment group ( +48 g ; 95 % CI : 1 , 96 g ; P = 0.046 ) .
RESULTS	Again , the effect increased with maternal BMI ( -8 , +79 , and +113 g ; P-interaction = 0.001 ) .
RESULTS	There were similar results for LBW ( intention-to-treat OR : 0.83 ; 95 % CI : 0.66 , 1.05 ; P = 0.10 ; per-protocol OR = 0.76 ; 95 % CI : 0.59 , 0.98 ; P = 0.03 ) but no effect on gestational age in either analysis .
CONCLUSIONS	A daily snack providing additional green leafy vegetables , fruit , and milk before conception and throughout pregnancy had no overall effect on birth weight .
CONCLUSIONS	Per-protocol and subgroup analyses indicated a possible increase in birth weight if the mother was supplemented 3 mo before conception and was not underweight .
CONCLUSIONS	This trial was registered at www.controlled-trials.com/isrctn/ as ISRCTN62811278 .

###26196407
BACKGROUND	It is unclear whether thiazide diuretics ( TZs ) or calcium channel blockers ( CCBs ) are more effective as add-on therapy to angiotensin receptor blockers ( ARBs ) in controlling hypertension .
BACKGROUND	Because TZs are a rational choice in salt-sensitive hypertension , patients with high salt intake might preferentially benefit from ARB/TZ over ARB/CCB combination therapy .
METHODS	Hypertensive patients who failed to reach blood pressure goals despite treatment with ARBs alone were randomly assigned to receive either ARB/TZ or ARB/CCB combination therapy .
METHODS	Estimated daily sodium intake was calculated from spot urine values of sodium and creatinine .
RESULTS	Blood pressure was measured at baseline , and at 4 , 8 and 12 weeks after starting combination therapy .
RESULTS	For all study patients ( n = 87 ) , diastolic blood pressure reduction was greater in patients receiving ARB/CCB treatment .
RESULTS	However , in the 37 patients with a baseline estimated daily salt intake greater than 10 g and baseline systolic blood pressure ( SBP ) ranging from 150 to 200 mm Hg , SBP was lower ( P < 0.05 ) and SBP reduction was greater ( P < 0.05 ) 4 weeks after starting combination therapy in those receiving ARB/TZ treatment .
RESULTS	In the 31 patients whose estimated daily salt intake increased at 12 weeks compared with baseline , SBP at 12 weeks was lower in those receiving ARB/TZ treatment ( P < 0.05 ) .
CONCLUSIONS	Estimated daily salt intake is a useful tool for guiding antihypertensive therapy and should be measured repeatedly during the therapeutic course .

###25076474
OBJECTIVE	To evaluate the effects of preservative-free 0.45 % ketorolac tromethamine and artificial tears ( carboxymethylcellulose ) compared with those of preservative-free artificial tears alone on the symptoms and signs of acute viral conjunctivitis .
METHODS	This was a randomized , double-masked clinical trial that included 50 patients who were diagnosed with acute viral conjunctivitis and distributed into two groups ( Group 0 : artificial tears and Group 1 : 0.45 % ketorolac tromethamine + carboxymethylcellulose ) .
METHODS	The patients were instructed to use the medication 4 times daily .
METHODS	Signs ( conjunctival hyperemia , chemosis , follicles , and secretion ) and symptoms ( general ocular discomfort , itching , foreign body sensation , tearing , redness , and swelling of the eyelids ) were scored at baseline and on the third and seventh days of treatment using a standardized questionnaire and slitlamp anterior segment examination .
RESULTS	Both groups showed an improvement in the signs and symptoms of conjunctivitis in their follow-up visits .
RESULTS	There was no significant difference in symptom and sign scores between Group 0 and Group 1 in the study visits ( p > 0.05 ) .
RESULTS	The frequency of side effects during treatment was similar between groups ( p > 0.05 ) .
CONCLUSIONS	Our findings indicate that 0.45 % ketorolac tromethamine was not superior to the use of artificial tears in relieving the signs and symptoms of viral conjunctivitis .

###25543614
OBJECTIVE	To apply role - play simulation in pre-clinical practice of the fourth grade students in department of endodontics .
METHODS	Thirty-two students were randomly divided into 2 groups , there were 16 students in each group .
METHODS	Students in one group were taught with role-play simulation while the other group with lecture-based learning method .
METHODS	The teaching effect was measured with examination and questionnaire survey .
METHODS	The data was analyzed by using SPSS 17.0 software package .
RESULTS	There were no significant differences in basic knowledge , case analysis and oral examination between 2 groups ( P > 0.05 ) , but there was significant difference in history taking and medical records writing , practical examination and total scores between 2 groups ( P < 0.05 ) .
RESULTS	The role-play simulation was generally approved by both teachers and students in experimental group .
CONCLUSIONS	The abilities of the fourth grade students can be developed by role-play simulation in different aspects .
CONCLUSIONS	Role-play simulation can be applied in pre-clinical practice of the fourth grade students in department of endodontics .

###25790213
BACKGROUND	The purpose of this 2-phase project was to conduct a formative evaluation and to test the preliminary efficacy of a newly developed Web-based Tailored Intervention for Preparation of parents and children undergoing Surgery ( WebTIPS ) .
METHODS	Phase 1 enrolled 13 children 2 to 7 years of age undergoing outpatient elective surgery and their parents for formative evaluation of WebTIPS .
METHODS	Parent participation focus groups are common in qualitative research and are a method of asking research participants about their perceptions and attitudes regarding a product or concept .
METHODS	In phase 2 , children 2 to 7 years of age in 2 medical centers were assigned randomly to receive the WebTIPS program ( n = 38 ) compared with children receiving the standard of care ( n = 44 ) .
METHODS	The primary outcome of phase II was child and parent preoperative anxiety .
RESULTS	In phase 2 , parents reported WebTIPS to be both helpful ( P < 0.001 ) and easy to use ( P < 0.001 ) .
RESULTS	In phase 2 , children in the WebTIPS group ( 36.2 14.1 ) were less anxious than children in the standard of care group ( 46.0 19.0 ) at entrance to the operating room ( P = 0.02 ; Cohen d = 0.59 ) and introduction of the anesthesia mask ( 43.5 21.7 vs 57.0 21.2 , respectively , P = 0.01 ; Cohen d = 0.63 ) .
RESULTS	Parents in the WebTIPS group ( 32.1 7.4 ) also experienced less anxiety compared with parents in the control group ( 36.8 7.1 ) in the preoperative holding area ( P = 0.004 ; Cohen d = 0.65 ) .
CONCLUSIONS	WebTIPS was well received by parents and children and led to reductions in preoperative anxiety .

###24707145
OBJECTIVE	To investigate the efficacy of a standard triple therapy ( comprising rabeprazole , clarithromycin , and amoxicillin ) for Helicobacter pylori ( H. pylori ) eradication , noting factors that influence the outcome and documenting any adverse events .
METHODS	Following institutional ethical approval , fifty consecutive and consenting symptomatic patients with evidence of H. pylori infection by either a positive urea breath test ( UBT ) and/or a campylobacter-like organism test who presented to the Gastroenterology clinic of Lagos State University Teaching Hospital between 2012 and 2013 were recruited into the study .
METHODS	Patients were openly randomized to either a 7-d or a 10-d regimen of amoxicillin 1 g , clarithromycin 500 mg and rabeprazole 20 mg twice daily .
METHODS	The extent of symptom resolution was noted following the treatment , and at the end of one month after the completion of treatment , a repeat UBT was performed in each patient to document the eradication of the infection .
METHODS	All data ( demographics , symptoms , and eradication rates ) were collated and analyzed with SPSS version 18 .
RESULTS	Forty-seven patients completed the study ( three were excluded from the analysis for breaching the study protocol ) .
RESULTS	The patients included 18 males and 29 females within the age range of 13-80 years ( mean 43.7 , SD 16.8 ) .
RESULTS	The clinical features of the study subjects were dyspepsia , reflux symptoms and features of gastrointestinal bleeding .
RESULTS	The average eradication rate was 87.2 % .
RESULTS	Eighteen subjects were enrolled in the 7-d arm , while 29 were in the 10-d arm .
RESULTS	There was no statistically significant difference in the age or sex distributions of the two arms .
RESULTS	There was no significant advantage of the 10-d treatment duration over the 7-d duration ( P = 0.78 ) , and the eradication outcomes were not influenced by the gender or age of the subjects .
RESULTS	No adverse effects were reported in either arm .
CONCLUSIONS	The triple therapy regime , employing a combination of amoxicillin , clarithromycin and rabeprazole , showed great efficacy and safety in the eradication of H. pylori , and this outcome was not influenced by gender or age .
CONCLUSIONS	No difference was observed between the 7-d and 10-d regimens .

###25431225
BACKGROUND	Traditional Chinese medicine ( TCM ) has accumulated some experience in curing stable angina pectoris ( SAP ) and efficacy has been demonstrated .
BACKGROUND	Chinese patent medicines , known as modern dosage forms of TCM , can attain the desired effect in clinical application only with the guidance of TCM syndrome theory .
BACKGROUND	However , due to their use by a large number of persons with little knowledge of TCM theories and practices , their efficacy and reputation have been seriously affected .
METHODS	Two common syndrome types of SAP in TCM , ` qi deficiency and blood stasis ' and ` qi stagnation and blood stasis ' , will be studied in 144 subjects from four TCM hospitals in Tianjin in China using a partial crossover design .
METHODS	The two syndromes will be broken down into six symptom combinations ; patients will select a combination of the most distressing to them , and then will be randomised into two groups .
METHODS	Each group , on the basis of routine medication , will be administered one kind of Chinese patent drug : Qishenyiqi Dripping Pills or Compound Danshen Dripping Pills .
METHODS	The treatment characteristics of the two medicines will be evaluated with the COME-PIO method developed by our research team .
BACKGROUND	This protocol has been approved by the medical ethics committee of Tianjin University of TCM ( registration number TJUTCM-EC20130005 ) .
BACKGROUND	The study is safe and reliable .
BACKGROUND	Chinese clinical trials register ChiCTR-TTRCC-14004406 .

###26030264
OBJECTIVE	Oral appliances that move the mandible forward during sleep are suggested as treatment for mild to moderate obstructive sleep apnea .
OBJECTIVE	To test whether an adjustable , custom-made oral appliance improves daytime sleepiness and quality of life in patients with daytime sleepiness and snoring or mild to moderate obstructive sleep apnea .
METHODS	Ninety-six patients with daytime sleepiness and an apnea-hypopnea index ( AHI ) lower than 30 were included in a randomized , placebo-controlled , parallel trial in Ume , Sweden , from May 2007 through August 2011 .
METHODS	Four months ' intervention with an oral appliance or a placebo device .
METHODS	Daytime sleepiness was measured with the Epworth Sleepiness Scale , the Karolinska Sleepiness Scale , and the Oxford Sleep Resistance ( OSLER ) test .
METHODS	Quality of life was assessed with the Short-Form 36-Item Health Survey ( SF-36 ) and the Functional Outcomes of Sleep Questionnaire ( FOSQ ) .
METHODS	Secondary outcomes included the apnea-hypopnea index , headaches , symptoms of restless legs , and insomnia .
RESULTS	Oral appliance therapy was not associated with improvements in daytime sleepiness from baseline to 4-month follow-up when compared with the placebo device ; Epworth score > 10 : 53 % at baseline to 24 % at follow-up for the oral appliance group vs 54 % at baseline to 40 % at follow-up for the placebo device group , P = .11 ; median ( IQR ) for Karolinska score 7/wk : 10 ( 8 to 14 ) at baseline to 7 ( 4 to 9 ) at follow-up for the oral appliance group vs 12 ( 6 to 15 ) at baseline to 8 ( 5 to 12 ) at follow-up for the placebo device group , P = .11 ; mean between-group difference in OSLER test , -2.4 min ( 95 % CI , -6.3 to 1.4 ) .
RESULTS	The mean between-group difference for the total FOSQ score was insignificant ( -1.2 [ 95 % CI , -2.5 to 0.1 ] ) .
RESULTS	No domain of the SF-36 differed significantly between the groups .
RESULTS	The AHI was below 5 in 49 % of patients using the active appliance and in 11 % using placebo , with an odds ratio of 7.8 ( 95 % CI , 2.6-23 .5 ) and a number needed to treat of 3 .
RESULTS	Snoring ( P < .001 ) and symptoms of restless legs ( P = .02 ) were less frequent when using the oral appliance vs placebo , but this did not apply to headache or insomnia .
CONCLUSIONS	A custom-made , adjustable oral appliance reduces obstructive sleep apnea , snoring , and possibly restless legs without effects on daytime sleepiness and quality of life among patients with daytime sleepiness and snoring or mild to moderate sleep apnea .
BACKGROUND	clinicaltrials.gov Identifier : NCT00477009 .

###24906374
OBJECTIVE	Non-invasive brain stimulation with transcranial direct current stimulation ( tDCS ) modulates cortical excitability and improves upper limb motor performance when applied to chronic stroke patients .
OBJECTIVE	The objective was to evaluate whether tDCS can influence gait function in sub-acute stroke patients .
METHODS	We assessed the effect of single session , bi-cephalic tDCS on gait performance in 14 subacute patients with stroke involving the cerebral hemisphere ( 2-8 weeks post-stroke ) in a double-blinded , sham-controlled study .
METHODS	Patients were randomly allocated to receive either active ( n = 7 ) or sham ( n = 7 ) tDCS .
METHODS	The anodal electrode was placed on the scalp over the ipsilesional lower limb primary motor cortex and the cathode was placed over the contralesional leg motor cortex .
METHODS	Gait performance was measured using the Timed Up and Go test and the Performance Oriented Mobility Assessment before and after active or sham tDCS .
RESULTS	The tDCS group was significantly quicker in the Timed Up and Go test in the tDCS group , compared to the sham group ( p = 0.018 ) .
RESULTS	The Performance Oriented Mobility Assessment was not different between groups ( p = 0.897 ) .
CONCLUSIONS	This is the first study to examine the effects of tDCS on gait in stroke patients in the sub-acute stage .
CONCLUSIONS	Active tDCS improved gait performance ( Timed Up and Go ) in stroke patients , despite no changes to limb biomechanics of the hemiparetic side ( Performance Oriented Mobility Assessment ) , as compared to sham stimulation .
CONCLUSIONS	These results suggest that tDCS could be used as a therapeutic adjunct for gait rehabilitation following stroke .

###25938474
OBJECTIVE	The Paliperidone Palmitate Research in Demonstrating Effectiveness ( PRIDE ) study compared the effects of once-monthly paliperidone palmitate with daily oral antipsychotics on treatment failure in adults with schizophrenia .
METHODS	The PRIDE study is a 15-month , randomized , multicenter study ( May 5 , 2010 , to December 9 , 2013 ) of adult subjects with a DSM-IV diagnosis of schizophrenia and a history of incarceration .
METHODS	Subjects were randomly assigned to once-monthly paliperidone palmitate injections or daily oral antipsychotics ( randomly assigned from 7 acceptable , prespecified oral antipsychotics ) for 15 months .
METHODS	The primary end point was time to first treatment failure , defined as arrest/incarceration ; psychiatric hospitalization ; suicide ; treatment discontinuation or supplementation due to inadequate efficacy , safety , or tolerability ; or increased psychiatric services to prevent hospitalization .
METHODS	Time to first treatment failure was determined by a blinded event-monitoring board and analyzed with the Kaplan-Meier method .
RESULTS	In this study , 450 patients were randomly assigned , and 444 were included in the intent-to-treat population .
RESULTS	Paliperidone palmitate was associated with significant delay in time to first treatment failure versus oral antipsychotics ( hazard ratio , 1.43 ; 95 % CI , 1.09-1 .88 ; log rank P = .011 ) .
RESULTS	Observed treatment failure rates over 15 months were 39.8 % and 53.7 % , respectively .
RESULTS	Arrest/incarceration and psychiatric hospitalization were the most common reasons for treatment failure in the paliperidone palmitate and oral antipsychotic groups ( 21.2 % vs 29.4 % and 8.0 % vs 11.9 % , respectively ) .
RESULTS	The 5 most common treatment-emergent adverse events for the paliperidone palmitate treatment group were injection site pain ( 18.6 % of subjects ) , insomnia ( 16.8 % ) , weight increased ( 11.9 % ) , akathisia ( 11.1 % ) , and anxiety ( 10.6 % ) .
CONCLUSIONS	In a trial designed to reflect real-world management of schizophrenia , once-monthly paliperidone palmitate demonstrated superiority compared to oral antipsychotics in delaying time to treatment failure .
BACKGROUND	Clinicaltrials.gov Identifier : NCT01157351 .

###24943996
BACKGROUND	Booster sessions as a means of maintaining the benefits of psycho-educational programs have received little attention in caregiving research .
BACKGROUND	Caregivers were offered a booster session following participation in a program entitled Learning to Become a Family Caregiver ( LBFC ) intended to facilitate transition to the caregiver role after diagnostic disclosure of dementia in a relative .
BACKGROUND	The 90-minute booster session served to review program content and afforded the opportunity to discuss and practice learned skills .
BACKGROUND	This study sought to test the efficacy of the booster session in maintaining or recovering program effects at six months post-program .
METHODS	Participants in the program were randomly assigned to a group that received the booster session ( n = 31 ) or a group that did not ( n = 29 ) .
METHODS	A third control group was also formed , which continued to receive only the usual care provided in memory clinics .
METHODS	Eligible participants - French-speaking primary caregivers of a relative diagnosed with Alzheimer 's in the past nine months - were recruited in memory clinics in Quebec ( Canada ) .
METHODS	Participants were blindly assessed before randomization and six months after the booster session on outcomes associated with a healthy role transition .
RESULTS	Prediction analyses revealed one significant positive effect of the booster session : emergence of preparedness to provide care .
RESULTS	Moreover , with or without the booster session , the program continued to have a positive effect on psychological distress and contributed to the emergence of self-efficacy in dealing with caregiving situations .
RESULTS	The booster session had no significant effect on knowledge of services , planning for future care needs , use of reframing as a coping strategy , perceived informal support , and family conflicts .
CONCLUSIONS	The limited effect observed is discussed in terms of the booster session 's content and intensity .
CONCLUSIONS	Recommendations are made for designing future research on the effect of booster sessions , including the importance of including a placebo booster group .

###25299520
OBJECTIVE	The aim of this study was to compare the effect of a 12-wk exercise therapy program and arthroscopic partial meniscectomy on knee strength and functional performance in middle-aged patients with degenerative meniscus tears .
METHODS	A total of 82 patients ( mean age , 49 yrs ; 35 % women ) with a symptomatic , unilateral , magnetic resonance imaging-verified degenerative meniscus tear and no or mild radiographic osteoarthritis were randomly assigned to a supervised neuromuscular and strength exercise program or arthroscopic partial meniscectomy .
METHODS	Outcomes assessed 3 mos after intervention initiation were isokinetic knee muscle strength , lower extremity performance , and self-reported global rating of change .
RESULTS	Mean difference in isokinetic knee extension peak torque between the two groups was 16 % ( 95 % confidence interval , 7.1-24 .0 ) ( P < 0.0001 ) , favoring the exercise group .
RESULTS	Patients in the exercise group improved isokinetic knee extension peak by a mean of 25 Nm ( range , 18-33 Nm ) from baseline to follow-up .
RESULTS	Furthermore , patients assigned to exercise therapy showed statistically significant improvements ( P 0.002 ) in all other measured variables , with moderate to large effect sizes ( 0.5-1 .3 ) .
RESULTS	Patients reported a similar and positive effect of both interventions .
CONCLUSIONS	A 12-wk supervised exercise therapy program yielded clinically relevant and statistically significant improvement in isokinetic quadriceps strength immediately after completion of the program , as compared with treatment with arthroscopic partial meniscectomy .

###25127231
BACKGROUND	Cervical dystonia is managed mainly by repeated botulinum toxin injections .
BACKGROUND	We aimed to establish whether pallidal neurostimulation could improve symptoms in patients not adequately responding to chemodenervation or oral drug treatment .
METHODS	In this randomised , sham-controlled trial , we recruited patients with cervical dystonia from centres in Germany , Norway , and Austria .
METHODS	Eligible patients ( ie , those aged 18-75 years , disease duration 3 years , Toronto Western Spasmodic Torticollis Rating Scale [ TWSTRS ] severity score 15 points ) were randomly assigned ( 1:1 ) to receive active neurostimulation ( frequency 180 Hz ; pulse width 120 s ; amplitude 05 V below adverse event threshold ) or sham stimulation ( amplitude 0 V ) by computer-generated randomisation lists with randomly permuted block lengths stratified by centre .
METHODS	All patients , masked to treatment assignment , were implanted with a deep brain stimulation device and received their assigned treatment for 3 months .
METHODS	Neurostimulation was activated in the sham group at 3 months and outcomes were reassessed in all patients after 6 months of active treatment .
METHODS	Treating physicians were not masked .
METHODS	The primary endpoint was the change in the TWSTRS severity score from baseline to 3 months , assessed by two masked dystonia experts using standardised videos , analysed by intention to treat .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00148889 .
RESULTS	Between Jan 19 , 2006 , and May 29 , 2008 , we recruited 62 patients , of whom 32 were randomly assigned to neurostimulation and 30 to sham stimulation .
RESULTS	Outcome data were recorded in 60 ( 97 % ) patients at 3 months and 56 ( 90 % ) patients at 6 months .
RESULTS	At 3 months , the reduction in dystonia severity was significantly greater with neurostimulation ( -51 points [ SD 51 ] , 95 % CI -70 to -35 ) than with sham stimulation ( -13 [ 24 ] , -22 to -04 , p = 00024 ; mean between-group difference 38 points , 18 to 58 ) in the intention-to-treat population .
RESULTS	Over the course of the study , 21 adverse events ( five serious ) were reported in 11 ( 34 % ) of 32 patients in the neurostimulation group compared with 20 ( 11 serious ) in nine ( 30 % ) of 30 patients in the sham-stimulation group .
RESULTS	Serious adverse events were typically related to the implant procedure or the implanted device , and 11 of 16 resolved without sequelae .
RESULTS	Dysarthria ( in four patients assigned to neurostimulation vs three patients assigned to sham stimulation ) , involuntary movements ( ie , dyskinesia or worsening of dystonia ; five vs one ) , and depression ( one vs two ) were the most common non-serious adverse events reported during the course of the study .
CONCLUSIONS	Pallidal neurostimulation for 3 months is more effective than sham stimulation at reducing symptoms of cervical dystonia .
CONCLUSIONS	Extended follow-up is needed to ascertain the magnitude and stability of chronic neurostimulation effects before this treatment can be recommended as routine for patients who are not responding to conventional medical therapy .
BACKGROUND	Medtronic .

###24647921
BACKGROUND	The 42 nicotinic acetylcholine receptor partial agonist varenicline has been reported to reduce drinking among both heavy-drinking smokers and primary alcoholics , and this effect may be related to varenicline-mediated reduction of alcohol craving .
BACKGROUND	Among smokers , varenicline has been reported to modulate cigarette cue-elicited brain activation in several reward-related areas .
OBJECTIVE	This pilot study tested varenicline 's effects on drinking , alcohol craving , and alcohol cue-elicited activation of reward-related brain areas among non-treatment-seeking alcohol-dependent individuals .
METHODS	Thirty-five such individuals ( mean age = 30 , 57 % male , 76 % heavy drinking days in the past month , 15 smokers ) were randomized to either varenicline ( titrated to 2 mg ) or placebo for 14 days , and were administered an alcohol cue reactivity fMRI task on day 14 .
METHODS	A priori regions of interest ( ROIs ) were bilateral and medial orbitofrontal cortex ( OFC ) , right ventral striatum ( VS ) , and medial prefrontal cortex ( mPFC ) .
RESULTS	Despite good medication adherence , varenicline did not reduce heavy drinking days or other drinking parameters .
RESULTS	It did , however , increase self-reported control over alcohol-related thoughts and reduced cue-elicited activation bilaterally in the OFC , but not in other brain areas .
CONCLUSIONS	These data indicate that varenicline reduces alcohol craving and some of the neural substrates of alcohol cue reactivity .
CONCLUSIONS	However , varenicline effects on drinking mediated by cue-elicited brain activation and craving might be best observed among treatment-seekers motivated to reduce their alcohol consumption .

###24976447
OBJECTIVE	Methotrexate ( MTX ) remains the gold standard disease-modifying antirheumatic drug for the treatment of rheumatoid arthritis ( RA ) .
OBJECTIVE	Few studies have compared different starting doses of MTX in RA .
OBJECTIVE	We hypothesized that starting with a higher MTX dose may be more effective but associated with more adverse effects .
OBJECTIVE	We compared a starting dose of 7.5 versus 15 mg per week of MTX followed by similar fast escalation .
METHODS	This was an open-label ( blinded assessor ) , parallel-group , randomized controlled trial that included RA patients aged 18 to 65 years , not on MTX , and having active disease ( Disease Activity Score for 28 joints using 3 variables [ DAS28 ( 3 ) ] 5.1 ) .
METHODS	Patients were randomized to receive MTX at a starting dose of 7.5 mg ( group 1 ) or 15 mg ( group 2 ) per week .
METHODS	The dose of MTX was escalated by 2.5 mg every 2 weeks to a maximum of 25 mg .
METHODS	Patients were seen every 4 weeks , and dose escalation was continued if DAS28 ( 3 ) was > 2.6 and there were no laboratory abnormalities ( transaminitis [ > 2 upper limit of normal ] or cytopenia ) .
METHODS	The primary endpoint was change in disease activity at 12 weeks ( assessed by using the DAS28 [ 3 ] ) .
METHODS	Secondary endpoints were patient withdrawals and episodes ofcytopenia or transaminitis .
METHODS	Adverse effects were ascertained by using a questionnaire .
METHODS	Both intention-to-treat and per-protocol analyses were performed .
RESULTS	We enrolled 100 patients ( female : male ratio , 78:22 ) with a mean ( SD ) age of 43.6 ( 10.8 ) years and a disease duration of 4.7 ( 4.8 ) years .
RESULTS	At baseline , patients had a mean DAS28 ( 3 ) of 6.2 ( 0.7 ) and a Health Assessment Questionnaire score of 1.3 ( 0.6 ) .
RESULTS	Group 1 ( 7.5 mg ) and group 2 ( 15 mg ) included 47 and 53 patients , respectively , with no significant differences in baseline characteristics .
RESULTS	At 12 weeks , the mean dose of MTX reached was 17.3 ( 4.6 ) mg in group 1 and 23.6 ( 3.0 ) mg in group 2 ( P < 0.001 ) .
RESULTS	The 2 groups had a similar number of patient withdrawals .
RESULTS	The mean change in DAS28 ( 3 ) at 12 weeks in group 1 ( -0.47 [ 0.86 ] ) and group 2 ( -0.55 [ 0.79 ] ) was not significantly different ( P = 0.60 ) .
RESULTS	The change in the Health Assessment Questionnaire score was also similar in the groups .
RESULTS	The frequency of episodes of transaminitis ( 6 and 7 ; P = 0.8 ) and cytopenia ( 1 and 2 ; P = 0.9 ) did not differ significantly between groups 1 and 2 , respectively .
RESULTS	Results remained the same according to the per-protocol analysis .
RESULTS	Among adverse effects , nausea was more common in group 2 compared with group 1 ( relative risk , 1.6 [ 95 % CI , 1.1-2 .2 ] ) .
CONCLUSIONS	There were no significant differences in efficacy between the 2 starting doses of MTX .
CONCLUSIONS	The fast escalation of dose in both groups may have blunted any advantage of starting at a higher dose .
CONCLUSIONS	Nausea occurred more commonly in patients started on 15 mg of MTX .
CONCLUSIONS	We suggest longer trials to confirm our findings .
CONCLUSIONS	ClinicalTrials.gov identifier : NCT01404429 .

###25618968
OBJECTIVE	To determine the effects of Anshendingzhi decoction ( ASDZD ) on depression , to compare ASDZD with Danzhixiaoyao pill ( DZXYP ) , and to provide evidence for the clinical treatment of depression with Traditional Chinese Medicine .
METHODS	Seventy-eight patients with depression were enrolled from 2011 to 2013 in this double-blinded study .
METHODS	Patients were randomly divided into two groups : ASDZD ( treatment group , n = 39 ) and DZXYP ( control group , n = 39 ) .
METHODS	Hamilton Depressive Scale and TCM Syndrome Differentiation Scale were used to assess depression and efficacy before treatment and 2 , 4 , and 6 weeks after treatment .
METHODS	The Treatment Emergent Symptoms Scale ( TESS ) was used to evaluate adverse reactions , observe , and record treatment outcomes .
RESULTS	ASDZD was significantly more effective than DZXYP .
RESULTS	There were significant differences between the two groups in terms of recovered patients , overall response rate , and TESS score ( all P < 0.05 ) .
CONCLUSIONS	ASDZD is an effective treatment for depression .
CONCLUSIONS	ASDZD could improve clinical symptoms and warrants further clinical research and application .

###24504937
OBJECTIVE	We studied the relationship between heart rate and renal function and the effects of heart rate reduction with ivabradine in heart failure patients with and without renal dysfunction .
RESULTS	From the 6505 patients who were randomized in SHIFT , baseline creatinine and at least one follow-up measurement were available in 6160 patients .
RESULTS	Median follow-up was 22.9 months .
RESULTS	Worsening renal function ( WRF ) was defined as a creatinine increase of 0.3 mg/dL and 25 % from the baseline value .
RESULTS	WRF developed in 1029 ( 17 % ) patients and was directly related to baseline heart rate , with an incremental risk of 5 % for every 5 b.p.m. heart rate increment ( P = 0.003 ) .
RESULTS	WRF was associated with an increased risk of the primary composite endpoint of hospitalization for worsening heart failure or cardiovascular death [ hazard ratio ( HR ) 1.38 , P < 0.001 ] and of all-cause mortality ( HR 1.42 , P < 0.001 ) .
RESULTS	Ivabradine use was associated with a reduction of the primary composite endpoint in patients both with ( HR 0.82 , P = 0.023 ) and without renal dysfunction ( HR 0.81 , P < 0.001 ) at baseline ( P for interaction = 0.89 ) , and tolerability of ivabradine was comparable in the two groups .
RESULTS	No differences were found in changes in renal function over time between ivabradine - and placebo-treated patients .
CONCLUSIONS	In chronic stable systolic heart failure patients , heart rate is directly and independently associated with the risk of WRF , but reduction in heart rate by ivabradine had a neutral effect on renal function during 2 years of follow-up .
CONCLUSIONS	The beneficial cardiovascular effects and safety of ivabradine were similar in patients with and without renal dysfunction .

###25613811
BACKGROUND	To compare the effect of bimatoprost and the fixed combination latanoprost-timolol ( LTFC ) on 24-hour systolic ( SBP ) and diastolic ( DBP ) blood pressure and on 24-hour ocular perfusion pressure ( OPP ) .
METHODS	200 patients with glaucoma or ocular hypertension , controlled on the unfixed combination of latanoprost and timolol or eligible for dual therapy being not being fully controlled on monotherapy were enrolled in a randomized , double-masked , placebo-controlled , multicentre clinical trial .
METHODS	They were randomized to LTFC ( 8 a.m. ) or bimatoprost ( 8 p.m. ) and received 24-hour IOP curve at baseline , 6 and 12 weeks ( supine and sitting position IOPs were recorded at 8 p.m. , midnight , 5 a.m. , 8a .
METHODS	m. , noon and 4 p.m. ) .
METHODS	Holter 24-hour blood pressure curve was obtained between weeks 2 and 12 .
METHODS	SBP , DBP , OPP were calculated and compared with ANOVA .
METHODS	Rates of diastolic OPP ( DPP ) 50 , 40 , 30 mmHg in the 2 groups were calculated and compared using Fisher 's test .
RESULTS	Mean baseline SBP and DBP were 136.518.3 vs 134.220.1 mmHg ( p = 0.1 ) and 79.110.2 vs 78.210.1 mmHg ( p = 0.4 ) in the bimatoprost and LTFC groups respectively .
RESULTS	Holter SBP was significantly higher for bimatoprost ( 135.1 mmHg vs 128.1 mmHg , p = 0.04 ) , while no statistically significant difference in DBP was found .
RESULTS	DPP was similar in the 2 groups , and proportions of patients with at least one value of the 24-hour curve50 , 40 , 30 mmHg were 94 % , 86 % , 41 % respectively .
CONCLUSIONS	Bimatoprost and LTFC had similar DBPs and OPPs ; SBP was significantly lower with LTFC .
CONCLUSIONS	In this study , the percentage of `` dippers '' was considerably higher than the one described in previous studies on the role of perfusion pressure in glaucoma .
BACKGROUND	NCT02154217 , May 21 , 2014 .

###25488040
BACKGROUND	Primary percutaneous coronary intervention ( PCI ) is the most common method of reperfusion in patients with ST-segment elevation myocardial infarction ( STEMI ) in the United States .
BACKGROUND	The intersection between processes of care and performance measures such as door-to-balloon ( D2B ) times and clinical trials evaluating novel therapies for STEMI has not been fully investigated .
OBJECTIVE	Processes of STEMI care , incorporating clinical trial enrollment and randomization , in patients undergoing reperfusion with primary PCI in the Counterpulsation Reduces Infarct Size Pre-Percutaneous Coronary Intervention Acute Myocardial Infarction trial ( CRISP-AMI ) will conform to current standards of care .
METHODS	Patients enrolled in CRISP-AMI were included in the current analysis .
METHODS	Processes of care during reperfusion were recorded prospectively and compared between groups .
RESULTS	A total of 337 patients with anterior STEMI without cardiogenic shock were randomized in CRISP-AMI .
RESULTS	Complete processes-of-care data were available for 303 patients ( 89.9 % ) .
RESULTS	In this cohort , 68.0 % of patients underwent reperfusion within 90 minutes of hospital contact , and the median D2B time was 71 minutes .
RESULTS	Time from hospital contact to informed consent was significantly different across different regions ( North America , 45 minutes ; India , 35 minutes ; Europe , 20 minutes ) .
CONCLUSIONS	In CRISP-AMI , reperfusion was accomplished in a timely fashion while incorporating informed consent and randomization among patients with anterior myocardial infarction .
CONCLUSIONS	Further study of patients ' comprehension and preferences during the informed-consent process in STEMI patients is warranted so that innovative drugs and devices can be safely and ethically tested .

###24339307
OBJECTIVE	To compare the epithelial wound healing response of two preservative-free fluoroquinolones , moxifloxacin and levofloxacin , in patients who underwent cataract surgery .
METHODS	In this prospective , evaluator-masked , randomized clinical trial , 59 eyes of 50 patients who underwent cataract surgery were enrolled .
METHODS	Patients were randomized to receive moxifloxacin 0.5 % ( n = 32 eyes ) or levofloxacin 0.5 % ( n = 27 eyes ) .
METHODS	All patients instilled moxifloxacin or levofloxain four times daily for 1 week prior to surgery and 2 weeks after surgery .
METHODS	The epithelial wound healing status in the corneal incision site was scanned with a raster scan mode of fourier-domain optical coherence tomography ( FD-OCT ) .
METHODS	The number of eyes showing epithelial defect images and average number of corneal epithelial defect cuts per eye were compared between groups .
METHODS	All patients were evaluated on postoperative days 1 , 2 , 3 , and 10 .
RESULTS	On postoperative days 1 , 2 , and 3 , the number of eyes showing epithelial defects in FD-OCT was not statistically different ( all p > 0.05 ) .
RESULTS	The average number of corneal epithelial defect cuts was also not statistically different between the two groups ( all p > 0.05 ) .
RESULTS	No eyes showed epithelial defects on postoperative day 10 in either group .
CONCLUSIONS	There were no differences on epithelial wound healing comparing these two different fluoroquinolones at the incision site of cataract surgery .

###25458801
BACKGROUND	This Phase 3 , international , randomized , single-blind , controlled trial ( FINISH-3 ) compared the efficacy and safety of Fibrocaps , a ready-to-use , dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen , vs gelatin sponge alone for use as a hemostat for surgical bleeding in 4 indications ( ie , spinal , hepatic , vascular , soft tissue dissection ) .
METHODS	Adults with mild to moderate surgical bleeding ( randomized 2:1 ; Fibrocaps vs gelatin sponge ) were treated at a single bleeding site ( day 1 ) .
METHODS	Time to hemostasis ( TTH ) during 5 minutes was compared ( log-rank statistic ) within each indication .
METHODS	Safety follow-up continued to day29 .
RESULTS	Patients were treated ( Fibrocaps , n = 480 ; gelatin sponge , n = 239 ) when undergoing spinal ( n = 183 ) , vascular ( n = 175 ) , hepatic ( n = 180 ) , or soft-tissue ( n = 181 ) procedures .
RESULTS	Fibrocaps was applied by spray device in 53 % of all procedures ( 94 % of hepatic and soft-tissue procedures ) .
RESULTS	Fibrocaps significantly reduced TTH compared with gelatin sponge ; estimated hazard ratios were 3.3 , 2.1 , 2.3 , and 3.4 for the 4 surgical indications , respectively ( each p < 0.001 ; primary end point ) .
RESULTS	Fibrocaps significantly reduced median TTH for each indication ( p < 0.001 ) and was superior for secondary efficacy end points of restricted mean TTH ( p < 0.001 ) and probability of hemostasis at 3 ( p < 0.001 ) and 5 ( p 0.002 ) minutes .
RESULTS	Adverse event incidences were generally similar between treatment arms .
RESULTS	Non-neutralizing , anti-thrombin antibodies developed in 2 % of Fibrocaps-treated and 3 % of gelatin sponge-treated patients .
CONCLUSIONS	Fibrocaps was well tolerated and significantly reduced TTH relative to gelatin sponge alone in all 4 surgical indications .
CONCLUSIONS	These findings demonstrate the broad utility of Fibrocaps as a hemostatic agent for mild to moderate surgical bleeding .

###25796459
BACKGROUND	High-dose therapy followed by autologous stem-cell transplantation is standard of care for patients with relapsed or primary refractory Hodgkin 's lymphoma .
BACKGROUND	Roughly 50 % of patients might be cured after autologous stem-cell transplantation ; however , most patients with unfavourable risk factors progress after transplantation .
BACKGROUND	We aimed to assess whether brentuximab vedotin improves progression-free survival when given as early consolidation after autologous stem-cell transplantation .
METHODS	We did this randomised , double-blind , placebo-controlled , phase 3 trial at 78 sites in North America and Europe .
METHODS	Patients with unfavourable-risk relapsed or primary refractory classic Hodgkin 's lymphoma who had undergone autologous stem-cell transplantation were randomly assigned , by fixed-block randomisation with a computer-generated random number sequence , to receive 16 cycles of 18 mg/kg brentuximab vedotin or placebo intravenously every 3 weeks , starting 30-45 days after transplantation .
METHODS	Randomisation was stratified by best clinical response after completion of salvage chemotherapy ( complete response vs partial response vs stable disease ) and primary refractory Hodgkin 's lymphoma versus relapsed disease less than 12 months after completion of frontline therapy versus relapse 12 months or more after treatment completion .
METHODS	Patients and study investigators were masked to treatment assignment .
METHODS	The primary endpoint was progression-free survival by independent review , defined as the time from randomisation to the first documentation of tumour progression or death .
METHODS	Analysis was by intention to treat .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01100502 .
RESULTS	Between April 6 , 2010 , and Sept 21 , 2012 , we randomly assigned 329 patients to the brentuximab vedotin group ( n = 165 ) or the placebo group ( n = 164 ) .
RESULTS	Progression-free survival by independent review was significantly improved in patients in the brentuximab vedotin group compared with those in the placebo group ( hazard ratio [ HR ] 057 , 95 % CI 040-081 ; p = 00013 ) .
RESULTS	Median progression-free survival by independent review was 429 months ( 95 % CI 304-429 ) for patients in the brentuximab vedotin group compared with 241 months ( 115-not estimable ) for those in the placebo group .
RESULTS	We recorded consistent benefit ( HR < 1 ) of brentuximab vedotin consolidation across subgroups .
RESULTS	The most frequent adverse events in the brentuximab vedotin group were peripheral sensory neuropathy ( 94 [ 56 % ] of 167 patients vs 25 [ 16 % ] of 160 patients in the placebo group ) and neutropenia ( 58 [ 35 % ] vs 19 [ 12 % ] patients ) .
RESULTS	At time of analysis , 28 ( 17 % ) of 167 patients had died in the brentuximab vedotin group compared with 25 ( 16 % ) of 160 patients in the placebo group .
CONCLUSIONS	Early consolidation with brentuximab vedotin after autologous stem-cell transplantation improved progression-free survival in patients with Hodgkin 's lymphoma with risk factors for relapse or progression after transplantation .
CONCLUSIONS	This treatment provides an important therapeutic option for patients undergoing autologous stem-cell transplantation .
BACKGROUND	Seattle Genetics and Takeda Pharmaceuticals International .

###24621999
OBJECTIVE	The aim of this study was to evaluate the effects of losartan on left ventricular ( LV ) hypertrophy and fibrosis in patients with nonobstructive hypertrophic cardiomyopathy ( HCM ) .
BACKGROUND	Despite evidence that myocardial hypertrophy and fibrosis are mediated by angiotensin II and are important determinants of morbidity and mortality in patients with HCM , no prior studies have evaluated the effects of angiotensin receptor blockers on LV hypertrophy and fibrosis with cardiac magnetic resonance imaging .
METHODS	In double-blind fashion , 20 patients ( 3 women , 17 men ; age : 51 13 years ) with HCM were randomly assigned to receive placebo ( n = 9 ) or losartan 50 mg twice a day ( n = 11 ) for 1 year .
METHODS	Cardiac magnetic resonance imaging was performed at baseline and 1 year to measure LV mass and extent of fibrosis as assessed by late gadolinium enhancement .
RESULTS	There was a trend toward a significant difference in the percent change in LV mass ( median [ interquartile range ] : +5 % [ -4 % to +21 % ] with placebo vs.-5 % [ -11 % to-0 .9 % ] with losartan ; p = 0.06 ) .
RESULTS	There was a significant difference in the percent change in extent of late gadolinium enhancement , with the placebo group experiencing a larger increase ( +31 % 26 % with placebo vs.-23 % 45 % with losartan ; p = 0.03 ) .
CONCLUSIONS	This pilot study suggests attenuation of progression of myocardial hypertrophy and fibrosis with losartan in patients with nonobstructive HCM .
CONCLUSIONS	Confirmation of these results in a larger trial is required to confirm a place for angiotensin receptor blockers in the management of patients with HCM .
CONCLUSIONS	( Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy ; NCT01150461 ) .

###24814486
OBJECTIVE	This study sought to test whether the newly developed platinum chromium ( PtCr ) - based everolimus-eluting stent ( EES ) is noninferior to the cobalt chromium ( CoCr ) - based zotarolimus-eluting stent ( ZES ) in all-comers receiving percutaneous coronary intervention ( PCI ) .
BACKGROUND	PtCr provides improved radial strength , conformability , and visibility compared with the CoCr alloy , but PtCr-based stents have not been tested in a wide range of patients receiving PCI .
BACKGROUND	Also , recent case series have raised the issue of longitudinal stent deformation ( LSD ) with newer drug-eluting stents .
METHODS	We randomly assigned 3,755 all-comers receiving PCI to PtCr-EES or CoCr-ZES .
METHODS	The primary outcome was target lesion failure ( TLF ) at 1-year post-PCI , defined as the composite of cardiac death , nonfatal target vessel-related myocardial infarction , and ischemia-driven target lesion revascularization .
METHODS	Post-hoc angiographic analysis was performed to qualitatively and quantitatively analyze LSD .
RESULTS	At 1 year , TLF occurred in 2.9 % and 2.9 % of the population in the PtCr-EES and CoCr-ZES groups , respectively ( superiority p = 0.98 , noninferiority p = 0.0247 ) .
RESULTS	There were no significant differences in the individual components of TLF as well as the patient-oriented clinical outcome .
RESULTS	Of 5,010 stents analyzed , LSD occurred in 0.2 % and 0 % in the PtCr-EES and CoCr-ZES groups , respectively ( p = 0.104 ) .
RESULTS	There was no significant difference in post-deployment stent length ratio between the 2 stents ( p = 0.352 ) .
CONCLUSIONS	At 1 year , PtCr-EES was noninferior to CoCr-ZES in all-comers receiving PCI .
CONCLUSIONS	Although LSD was observed only in PtCr-EES , both the stent length ratio and the frequency of LSD were not significantly different between the 2 stent types , and PtCr-EES was not associated with adverse clinical outcomes .
CONCLUSIONS	( Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-SAfety & EffectiveneSS of Drug-ElUting Stents & Anti-platelet REgimen [ HOST-ASSURE ] ; NCT01267734 ) .

###25188224
OBJECTIVE	Prospective long-term analyses of the role of drug-induced mydriasis and laser peripheral iridotomy ( LPI ) are needed to identify and manage the eyes of patients with pigment dispersion syndrome ( PDS ) at risk for progressing to ocular hypertension .
OBJECTIVE	To assess the 10-year incidence of increased intraocular pressure ( IOP ) in the 2 eyes of patients with PDS , with 1 eye that underwent LPI and the other that did not .
METHODS	In a randomized clinical trial in the glaucoma research unit at the University Hospital of Parma , Italy , 72 patients with PDS underwent phenylephrine testing .
METHODS	Of these 72 patients , 29 ( 58 eyes ) tested positive for succeeding IOP elevation , and 43 ( 59 eyes ) tested negative .
METHODS	For the 29 high-risk patients ( all in both eyes ) , one eye was randomly assigned to LPI , and the fellow eye was left untreated .
METHODS	For the 43 low-risk patients , the affected eyes were left untreated .
METHODS	An IOP elevation of 5 mm Hg or higher vs baseline ( daily phasing ) was considered to be a significant increase ( ie , an event ) .
RESULTS	In the high-risk group , 3 of 21 eyes that underwent LPI ( 14.3 % ) and 13 of 21 untreated eyes ( 61.9 % ) showed an increase in IOP of 5 mm Hg or higher during the follow-up period ; 4 of 35 low-risk eyes ( 11.4 % ) showed a similar increase .
RESULTS	Event-free mean ( SD ) time was 7.99 ( 0.43 ) years for high-risk treated eyes , 3.89 ( 0.68 ) years for high-risk untreated eyes , and 7.16 ( 0.23 ) years for low-risk eyes .
RESULTS	The log-rank test showed the following : P < .001 for treated high-risk eyes vs untreated high-risk eyes , P = .74 for treated high-risk eyes vs low-risk eyes , and P < .001 for untreated high-risk eyes vs low-risk eyes .
CONCLUSIONS	At the end of the 10-year follow-up , ( 1 ) approximately one-third of the whole PDS patient population showed an IOP increase of 5 mm Hg or higher in at least 1 eye ; ( 2 ) phenylephrine testing identified eyes at high risk for developing IOP elevation ; and ( 3 ) LPI , when performed on high-risk eyes , reduced the rate of IOP elevation to the same level as the low-risk eyes .
BACKGROUND	clinicaltrials.gov Identifier : NCT01053416 .

###24948414
OBJECTIVE	Compared with a dry environment with talcum powder , a wet , alkaline environment with NaHCO3 solution is better for hair removal , as it can soften and expand the hair , decrease the friction and shear forces on the skin , and make hair removal easier and more efficient .
OBJECTIVE	The purpose of this study was to compare the effects of a preoperative skin preparation of 5 % NaHCO3 with that of talcum powder for softening hair in patients undergoing coronary artery bypass graft ( CABG ) surgery with the saphenous vein .
METHODS	A prospective randomized , single-blinded , controlled study was established .
METHODS	Between March 2012 and June 2013 , 120 patients who met the inclusion and exclusion criteria underwent elective CABG surgery with the saphenous vein in our hospital .
METHODS	The same doctor obtained the saphenous vein of each patient by a uniform method .
METHODS	CABG surgery was performed through an open or endoscopic technique , according to each patient 's condition .
METHODS	Patients were divided into two groups of 60 patients each , according to whether the preoperative skin preparation procedure was performed with a 5 % solution of NaHCO3 at 45-50C ( experimental group ) or with talcum powder ( control group ) .
METHODS	Main outcome measures were the incision inflammation rate , skin preparation time , presence of shaving-induced macroscopic haemorrhagic spots , verbal rating scale ( VRS ) pain score and satisfaction .
RESULTS	Neither group had any evidence of incision inflammation .
RESULTS	The average ( mean standard deviation ) skin preparation time of the experimental group was shorter than that of the control group ( 5.58 1.52 vs 9.74 1.23 min , P < 0.001 ) .
RESULTS	Three patients in the experimental group and 17 in the control group had shaving-induced macroscopic haemorrhagic spots after skin preparation ( P = 0.001 ) .
RESULTS	The VRS pain scores were different between the two groups ( P < 0.001 ) .
RESULTS	In the control group , 40 % of patients and 37 % of nurses were satisfied with the skin preparation procedure , compared with 95 and 90 % , respectively , in the experimental group ( both P < 0.001 ) .
CONCLUSIONS	Hair softening with a 5 % NaHCO3 solution protected the skin integrity , alleviated pain and improved patient satisfaction to a greater extent than talcum powder .
CONCLUSIONS	Nurses found the 5 % NaHCO3 solution to be more convenient and less time-consuming to use .

###24835038
BACKGROUND	The Coronary Psychosocial Evaluation Studies trial demonstrated promising results for enhanced depression treatment to reduce cardiovascular risk of patients with acute coronary syndrome and comorbid depression , but the long-term effectiveness of this intervention is unclear .
METHODS	A total of 157 participants with persistent depression after hospitalization for acute coronary syndromes were enrolled in the Coronary Psychosocial Evaluation Studies trial .
METHODS	A total of 80 participants were allocated to 6 months of enhanced depression treatment , and 77 participants were allocated to usual care .
METHODS	We report on an additional 12 months of observational follow-up for the composite outcome of death or first hospitalization for myocardial infarction or unstable angina .
RESULTS	Although the intervention was previously shown to have favorable cardiovascular effects during the treatment period , we observed a significant time-by-treatment group interaction during extended follow-up ( P = .008 ) .
RESULTS	Specifically , during the 6-month treatment period , death or hospitalization for myocardial infarction/unstable angina occurred in 3 participants ( 4 % ) in the treatment group compared with 11 participants ( 14 % ) in the usual care group ( hazard ratio , 0.25 ; 95 % confidence interval , 0.07-0 .90 ; P = .03 ) .
RESULTS	In contrast , during 12 months of additional observational follow-up , 11 participants ( 14 % ) in the treatment group experienced the composite outcome of deathorhospitalization for myocardial infarction/unstable angina compared with 3 participants ( 4 % ) in the usual caregroup ( hazard ratio , 2.91 ; 95 % confidence interval , 0.80-10 .56 ; P = .10 ) .
CONCLUSIONS	Enhanced depression treatment was associated with a reduced risk of death or hospitalization for myocardial infarction/unstable angina during active treatment , but this effect did not persist after treatment ceased .
CONCLUSIONS	Future research is needed to confirm our findings and to determine the optimal duration of depression treatment in patients with depression after acute coronary syndromes .

###24713222
BACKGROUND	A complication of long-term use of tunneled cuffed catheters for hemodialysis is the high rate of infection and thrombus-related dysfunction .
BACKGROUND	Specific mechanical features of tunneled cuffed catheters may improve hemodynamic performance and decrease thrombosis and infection rates .
BACKGROUND	However , there currently is no proven advantage of one design over another .
METHODS	Single-center randomized clinical trial .
METHODS	302 hemodialysis patients who required a tunneled cuffed catheter as temporary or definite vascular access .
METHODS	Palindrome Symmetric Tip Dialysis Catheter or HemoStar Long-Term Hemodialysis Catheter .
METHODS	The primary end point was primary assisted patency .
METHODS	Secondary end points were incidence of catheter-related bloodstream infections ( CRBSIs ) , thrombosis , and 2 indicators of rheologic function : mean effective blood flow rate and urokinase use .
RESULTS	Mean primary assisted patency was 135.9 days for Palindrome and 136.5 days for HemoStar ( P = 0.8 ) .
RESULTS	Definite CRBSI occurred in 0.24 and 0.10 / 1,000 catheter-days for Palindrome and HemoStar , respectively ( P = 0.3 ) .
RESULTS	Removal rates for thrombosis that could not be resolved with thrombolysis were 0.53 and 0.43 / 1,000 catheter-days for Palindrome and HemoStar , respectively ( P = 0.7 ) .
RESULTS	Urokinase use was lower for Palindrome than for HemoStar , as evidenced by a lower number of urokinase infusions/1 ,000 catheter-days ( 17 and 35 ; P < 0.001 ) and higher number of catheters that never required thrombolysis ( 58 % and 45 % ; P = 0.03 ) .
RESULTS	Mean effective blood flow rate was higher for Palindrome than for HemoStar ( 333 and 304mL/min ; P < 0.001 ) .
CONCLUSIONS	Single-center nonblinded trial .
CONCLUSIONS	Primary assisted patency and incidence of infection and thrombosis were similar for both catheter types .
CONCLUSIONS	The Palindrome catheter required less thrombolysis and achieved higher blood flow rates than the HemoStar catheter .
CONCLUSIONS	These findings suggest that mechanical catheter design may improve catheter rheology , but does not affect risks for thrombosis and infection and hence catheter survival .

###24449961
OBJECTIVE	To assess whether the addition of a peer testimonial to an informational mailing increases conversion rates from brand name prescription medications to lower-cost therapeutic equivalents , and whether the testimonial 's efficacy increases when information is added about an affiliation the quoted individual shares with the recipient .
METHODS	A total of 5498 union members were randomly assigned to receive 1 of 3 different informational letters : 1 without a testimonial ( No Testimonial Group ) , 1 with a testimonial from a person whose shared union affiliation with the recipient was not disclosed ( Unaffiliated Testimonial Group ) , and 1 with a testimonial from a person whose shared union affiliation with the recipient was disclosed ( Affiliated Testimonial Group ) .
RESULTS	The conversion rate for the No Testimonial Group was 12.2 % , which is higher than the Unaffiliated Testimonial Group rate of 11.3 % and the Affiliated Testimonial Group rate of 11.7 % .
RESULTS	The differences between the groups are not statistically significant .
CONCLUSIONS	Short peer testimonials do not increase the impact of a mailed communication on conversion rates to lower-cost , therapeutically equivalent medications , even when the testimonial is presented as coming from a more socially proximate peer

###25204316
BACKGROUND	Chronic systemic inflammation is common in patients with chronic kidney disease on dialysis ( CKD5D ) and has been considered a key mediator of the increased cardiovascular risk in this patient population .
BACKGROUND	In this study , we tested the hypothesis that supplementation of omega-3 polyunsaturated fatty acids ( -3 PUFAs ) will attenuate the systemic inflammatory process in CKD5D patients .
METHODS	The design was a randomized , double-blinded , placebo controlled pilot trial ( NCT00655525 ) .
METHODS	Thirty-eight patients were randomly assigned in a 1 : 1 fashion to receive 2.9 g of eicosapentaenoic acid ( C20 :5 , n-3 ) plus docosahexaenoic acid ( C22 :6 , n-3 ) versus placebo for 12 weeks .
METHODS	The primary outcome was change in pro-inflammatory chemokines measured by lipopolysaccharide ( LPS ) - stimulated peripheral blood mononuclear cells ( PBMCs ) .
METHODS	Secondary outcomes were changes in systemic inflammatory markers .
METHODS	Analysis of covariance was used to compare percent change from baseline to 12 weeks .
RESULTS	Thirty-one patients completed 12 weeks and three patients completed 6 weeks of the study .
RESULTS	Median age was 52 ( interquartile range 45 , 60 ) years , 74 % were African-American and 79 % were male .
RESULTS	Supplementation of -3 PUFAs effectively decreased the LPS-induced PBMC expression of RANTES ( Regulated upon Activation , Normal T cell Expressed and Secreted ) and MCP-1 ( Monocyte Chemotactic Protein-1 ; unadjusted P = 0.04 and 0.06 ; adjusted for demographics P = 0.02 and 0.05 , respectively ) .
RESULTS	There was no significant effect of the intervention on serum inflammatory markers ( C-reactive protein , interleukin-6 and procalcitonin ) .
CONCLUSIONS	The results of this pilot study suggest that supplementation of -3 PUFAs is beneficial in decreasing the levels of endothelial chemokines , RANTES and MCP-1 .
CONCLUSIONS	Studies of larger sample size and longer duration are required to further evaluate effects of -3 PUFAs on systemic markers of inflammation , other metabolic parameters and clinical outcomes , particularly cardiovascular outcomes in CKD5D patients .

###26001243
OBJECTIVE	This large-scale randomized study aimed to show the noninferiority in terms of diagnostic performance of gadoterate meglumine-enhanced versus gadobutrol-enhanced 3-T MR angiography ( MRA ) using digital subtraction angiography ( DSA ) as the reference standard in patients with peripheral arterial occlusive disease ( PAOD ) .
METHODS	In this prospective international randomized double-blind phase IV trial , 189 patients were enrolled .
METHODS	Of them , 156 could be included in the per-protocol population for on-site assessments and 154 for off-site readings .
METHODS	Subjects underwent peripheral MRA , after injection of 0.1 mmol/kg of either gadoterate meglumine or gadobutrol , and DSA within 30 days .
METHODS	The diagnostic accuracy was evaluated and compared using a noninferiority analysis .
METHODS	Secondary endpoints included sensitivity , specificity , diagnostic confidence , contrast-to-noise ratio , and signal-to-noise ratio evaluations .
RESULTS	The percentage agreement between MRA and DSA for stenosis detection was similar for on-site readings for both groups ( mean SD , 80.6 % 16.1 % with gadoterate meglumine vs 77.1 % 19.6 % with gadobutrol ; 3.5 % difference ) , and the same was true for off-site readings ( 73.9 % 16.9 % with gadoterate meglumine vs 75.1 % 13.8 % with gadobutrol ; 1.1 % difference ) .
RESULTS	The noninferiority of gadoterate meglumine to gadobutrol was shown for both on - and off-site readings .
RESULTS	Sensitivity in detecting significant stenosis ( > 50 % ) was 72.3 % for gadoterate meglumine versus 70.6 % for gadobutrol , whereas specificity ( 92.6 % vs 92.3 % ) , diagnostic confidence ( 87.0 % vs 86.0 % ) , signal-to-noise ratio ( 165.5 vs 161.0 ) , and contrast-to-noise ratio ( 159.5 vs 155.3 ) did not differ statistically significantly between the two groups .
CONCLUSIONS	Gadoterate meglumine was found to be not inferior to gadobutrol in terms of diagnostic performance in patients with PAOD undergoing 3-T contrast-enhanced MRA .
CONCLUSIONS	No statistically significant differences were detected between the two MRA groups .

###25657183
OBJECTIVE	The Scandinavian Candesartan Acute Stroke Trial ( SCAST ) found no benefits of blood pressure-lowering treatment with candesartan in acute stroke .
OBJECTIVE	We have investigated whether the effect of treatment is different in different subtypes of ischemic stroke .
METHODS	SCAST was a randomized - and placebo-controlled trial of candesartan in 2029 patients presenting within 30 hours of ischemic or hemorrhagic stroke and systolic blood pressure 140 mm Hg .
METHODS	Ischemic stroke subtype was categorized by the Oxfordshire Community Stroke Project classification .
METHODS	There were 2 primary effect variables : the composite vascular end point of vascular death , myocardial infarction , or stroke during the first 6 months and functional outcome at 6 months .
RESULTS	A total of 1733 patients with ischemic stroke were included : total anterior circulation infarcts in 129 , partial anterior in 850 , posterior in 236 , and lacunar in 510 patients .
RESULTS	For functional outcome there was a significant trend toward a better effect of candesartan in patients with larger infarcts ( total anterior circulation or partial anterior circulation ) than in patients with smaller infarcts ( lacunar infarction ; P = 0.02 ) .
RESULTS	For the composite vascular end point , there were no differences in treatment effect .
CONCLUSIONS	The results suggest that the effect of blood pressure-lowering treatment with candesartan may differ according to different types of acute ischemic stroke , but this needs to be confirmed in future trials .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00120003 .

###24716835
OBJECTIVE	To evaluate the efficacy and safety of oral lubiprostone for relieving symptoms of opioid-induced constipation ( OIC ) in patients with chronic noncancer pain .
METHODS	Prospective , randomized , double-blind , placebo-controlled trial .
METHODS	Seventy-nine US and Canadian centers .
METHODS	Patients aged 18 years with OIC , defined as < 3 spontaneous bowel movements ( SBMs ) per week .
METHODS	Patients received lubiprostone 24 mcg or placebo twice daily for 12 weeks .
METHODS	The primary endpoint was change from baseline in SBM frequency at week 8 .
RESULTS	Among randomized patients ( N = 418 ; lubiprostone , N = 210 ; placebo , N = 208 ) , most completed the study ( lubiprostone , 67.1 % ; placebo , 69.7 % ) .
RESULTS	The safety and efficacy ( intent-to-treat ) populations included 414 ( lubiprostone , N = 208 ; placebo , N = 206 ) and 413 ( lubiprostone , N = 209 ; placebo , N = 204 ) patients , respectively .
RESULTS	The mean ( standard deviation ) age was 50.4 ( 10.9 ) years ; most patients were female ( 64.4 % ) and white ( 77.7 % ) .
RESULTS	Changes from baseline in SBM frequency rates were significantly higher at week 8 ( P = 0.005 ) and overall ( P = 0.004 ) in patients treated with lubiprostone compared with placebo .
RESULTS	Pairwise comparisons showed significantly greater overall improvement for abdominal discomfort ( P = 0.047 ) , straining ( P < 0.001 ) , constipation severity ( P = 0.007 ) , and stool consistency ( P < 0.001 ) with lubiprostone compared with placebo .
RESULTS	Moreover , patients rated the effectiveness of lubiprostone as significantly ( P < 0.05 ) better than placebo for 11 of 12 weeks .
RESULTS	The most common treatment-related adverse events ( AEs ) with lubiprostone and placebo were nausea ( 16.8 % vs 5.8 % , respectively ) , diarrhea ( 9.6 % vs 2.9 % ) , and abdominal distention ( 8.2 % vs 2.4 % ) .
RESULTS	No lubiprostone-related serious AEs occurred .
CONCLUSIONS	Lubiprostone effectively relieved OIC and associated signs and symptoms and was well tolerated in patients with chronic noncancer pain ( http://clinicaltrials.gov/ct2/show/NCT00595946 ) .

###24495633
BACKGROUND	Despite the efforts of the healthcare community to improve the quality of diabetes care , about 50 % of people with type 2 diabetes do not reach their treatment targets , increasing the risk of future micro-and macro-vascular complications .
BACKGROUND	Diabetes self-management education has been shown to contribute to better disease control .
BACKGROUND	However , it is not known which strategies involving educational programs are cost-effective .
BACKGROUND	Telehealth applications might support chronic disease management .
BACKGROUND	Transferability of successful distant patient self-management support programs to the Belgian setting needs to be confirmed by studies of a high methodological quality .
BACKGROUND	`` The COACH Program '' was developed in Australia as target driven educational telephone delivered intervention to support people with different chronic conditions .
BACKGROUND	It proved to be effective in patients with coronary heart disease after hospitalization .
BACKGROUND	Clinical and cost-effectiveness of The COACH Program in people with type 2 diabetes in Belgium needs to be assessed .
METHODS	Randomized controlled trial in patients with type 2 diabetes .
METHODS	Patients were selected based on their medication consumption data and were recruited by their sickness fund .
METHODS	They were randomized to receive either usual care plus `` The COACH Program '' or usual care alone .
METHODS	The study will assess the difference in outcomes between groups .
METHODS	The primary outcome measure is the level of HbA1c .
METHODS	The secondary outcomes are : Total Cholesterol , LDL-Cholesterol , HDL-Cholesterol , Triglycerides , Blood Pressure , body mass index , smoking status ; proportion of people at target for HbA1c , LDL-Cholesterol and Blood Pressure ; self-perceived health status , diabetes-specific emotional distress and satisfaction with diabetes care .
METHODS	The follow-up period is 18 months .
METHODS	Within-trial and modeled cost-utility analyses , to project effects over life-time horizon beyond the trial duration , will be undertaken from the perspective of the health care system if the intervention is effective .
CONCLUSIONS	The study will enhance our understanding of the potential of telehealth in diabetes management in Belgium .
CONCLUSIONS	Research on the clinical effectiveness and the cost-effectiveness is essential to support policy makers in future reimbursement and implementation decisions .

###24648018
BACKGROUND	Diet and exercise interventions for cancer survivors result in health benefits ; however , few studies have examined health outcomes in relation to adherence .
OBJECTIVE	We examined associations between adherence to components of a diet-exercise intervention and survivors ' physical and mental health .
METHODS	A randomized controlled trial tested a telephone and mailed print intervention among 641 older , overweight , long-term survivors of breast , prostate , and colorectal cancer .
METHODS	Dietary and exercise behaviors were assessed at 14 time points throughout the year-long intervention ; health outcomes were examined postintervention .
RESULTS	Telephone session attendance had significant indirect relationships with health outcomes through intervention-period exercise and dietary behavior .
RESULTS	Attendance showed positive indirect relationships with physical function ( = 0.11 , p < 0.05 ) , basic and advanced lower extremity function ( = 0.10 , p < 0.05 / = 0.09 , p < 0.05 ) , and mental health ( = 0.05 , p < 0.05 ) , and a negative indirect relationship with body mass index ( = -0.06 , p < 0.05 ) .
CONCLUSIONS	Session attendance is vital in facilitating improvement in health behaviors and attendant outcomes ( Clinicaltrials.gov number NCT00303875 ) .

###24627416
OBJECTIVE	To investigate the putative modifying effect of dual antiplatelet therapy ( DAPT ) use on the incidence of stent thrombosis at 3 years in patients randomized to Endeavor zotarolimus-eluting stent ( E-ZES ) or Cypher sirolimus-eluting stent ( C-SES ) .
RESULTS	Of 8709 patients in PROTECT , 4357 were randomized to E-ZES and 4352 to C-SES .
RESULTS	Aspirin was to be given indefinitely , and clopidogrel/ticlopidine for 3 months or up to 12 months after implantation .
RESULTS	Main outcome measures were definite or probable stent thrombosis at 3 years .
RESULTS	Multivariable Cox regression analysis was applied , with stent type , DAPT , and their interaction as the main outcome determinants .
RESULTS	Dual antiplatelet therapy adherence remained the same in the E-ZES and C-SES groups ( 79.6 % at 1 year , 32.8 % at 2 years , and 21.6 % at 3 years ) .
RESULTS	We observed a statistically significant ( P = 0.0052 ) heterogeneity in treatment effect of stent type in relation to DAPT .
RESULTS	In the absence of DAPT , stent thrombosis was lower with E-ZES vs. C-SES ( adjusted hazard ratio 0.38 , 95 % confidence interval 0.19 , 0.75 ; P = 0.0056 ) .
RESULTS	In the presence of DAPT , no difference was found ( 1.18 ; 0.79 , 1.77 ; P = 0.43 ) .
CONCLUSIONS	A strong interaction was observed between drug-eluting stent type and DAPT use , most likely prompted by the vascular healing response induced by the implanted DES system .
CONCLUSIONS	These results suggest that the incidence of stent thrombosis in DES trials should not be evaluated independently of DAPT use , and the optimal duration of DAPT will likely depend upon stent type ( Clinicaltrials.gov number NCT00476957 ) .

###25212929
BACKGROUND	Safe venepuncture technique is a critical skill for health care professionals , to avoid accidental occupational injury .
BACKGROUND	This study investigates whether watching an instructional video improves medical students ' ability to perform venepuncture safely .
METHODS	This was a randomised , controlled , assessor-blinded trial that evaluated the utility of an instructional video , with the primary outcome of the ability to perform venepuncture safely .
METHODS	Forty-two second-year medical students were recruited and randomised to receive either video instruction ( group A , n = 20 ) or no intervention ( group B , n = 22 ) .
METHODS	Prior to the study , all students attended an instructor-led workshop on venepuncture .
METHODS	During the study , students were paired and instructed to perform venepuncture on a partner .
METHODS	Performance was assessed using a points-based checklist .
METHODS	Pre - and post-study surveys were conducted to assess confidence with technique .
RESULTS	The mean total checklist score was higher in group A than in group B , with values of 14.15 and 9.18 , respectively ( p < 0.0001 , maximum 18 points ) .
RESULTS	Mean scores were also higher in group A than in group B among students who performed first ( p = 0.008 ) and students who performed second ( p = 0.005 ) within the pair .
RESULTS	From the post-procedure survey , only group A rated increased confidence in performing venepuncture after the study ( p = 0.008 ) .
CONCLUSIONS	Students who watched an instructional video performed venepuncture more effectively and reported greater confidence with the technique .
CONCLUSIONS	Medical students can benefit from having access to an instructional video on venepuncture as an adjunct to the standard curriculum .
CONCLUSIONS	Safe venepuncture technique is a critical skill for health care professionals .

###24566877
BACKGROUND	Hospital admissions may provide an opportunity to discontinue potentially inappropriate medications ( PIMs ) in older patients .
BACKGROUND	Little is known about the effect of using the Screening Tool of Older People 's potentially inappropriate Prescriptions ( STOPP ) in this context .
BACKGROUND	This study aimed to test the hypothesis that specific STOPP recommendations from an inpatient geriatric consultation team ( IGCT ) to the hospital physician leads to reductions in PIMs for patients at discharge .
METHODS	This was a randomised controlled study in 146 frail inpatients ( in 2011 ) .
METHODS	The intervention consisted of STOPP recommendations made by the IGCT to ward physicians to discontinue PIMs , in addition to the standard geriatric advice .
RESULTS	Intervention ( n = 74 ) and control ( n = 72 ) groups were similar in terms of patient characteristics ( median age 85years ; median number of daily drugs , seven ) and PIM distribution ( 68 and 57 PIMs in 53 and 51 % of patients , respectively ) .
RESULTS	At discharge , the reduction in PIMs was twice as high for the intervention group as for the control group ( 39.7 and 19.3 % , respectively ; p = 0.013 ) .
RESULTS	The proportion of patients who still had one or more PIM at discharge did not differ between groups .
RESULTS	In the 50 patients followed-up a year later , the majority of PIMs that had been stopped during hospitalisation had not been restarted after discharge ( 17/28 ; 61 % ) .
RESULTS	The clinical relevance of PIMs identified at baseline in those patients was considered major ( 29 % ) , moderate ( 37 % ) , minor ( 5 % ) , deleterious ( 8 % ) , or not assessed ( 11 % ) .
RESULTS	Discontinuation rate was not associated with clinical importance .
CONCLUSIONS	Specific STOPP recommendations provided to hospital physicians doubled the reduction of PIMs at discharge in frail older inpatients .
CONCLUSIONS	To further improve the appropriateness of prescribing in older patients , clinicians should focus on the STOPP criteria that are of major clinical importance , and general practitioners should be actively involved .

###25344383
OBJECTIVE	We investigated induction of - secretase A disintegrin and metalloprotease 10 ( ADAM10 ) by the synthetic retinoid acitretin ( Neotigason ; Actavis , Mnchen-Riem , Germany ) in patients with mild to moderate Alzheimer disease ( AD ) via measurement of CSF content of - secretase-derived amyloid precursor protein ( APPs - ) .
METHODS	Twenty-one patients clinically diagnosed with mild to moderate AD received acitretin ( 30 mg per day ) or placebo in a 4-week double-blind study .
METHODS	Primary endpoint was the difference of CSF APPs - ratios calculated from the APPs - levels after treatment and at baseline .
METHODS	We monitored safety and tolerability of the treatment .
METHODS	In addition , we assessed biomarkers such as - amyloid 42 ( A42 ) under treatment conditions .
RESULTS	The acitretin group showed a significant increase in CSF APPs - levels compared with the placebo group ( difference 0.38 , 95 % confidence interval 0.03-0 .72 , p = 0.035 ) within this rather short treatment period .
RESULTS	The synthetic retinoid acitretin was overall safe and well tolerated .
CONCLUSIONS	Our pilot study highlights that acitretin is able to enhance the nonamyloidogenic APP processing in human patients .
CONCLUSIONS	Clinical consequences of this regulation should be investigated in larger and longer trials in patients with AD to evaluate acitretin 's potential to serve as a novel therapeutic drug .
METHODS	This study provides Class III evidence that in patients with AD , oral acitretin increases CSF APPs - levels .

###24714414
BACKGROUND	H.P. Acthar ( ) Gel is currently the only Food and Drug Administration therapy approved for the treatment of nephrotic syndrome .
BACKGROUND	Active drug ingredients include structurally related melanocortin peptides that bind to cell surface G-protein-coupled receptors known as melanocortin receptors , which are expressed in glomerular podocytes .
BACKGROUND	In animal models of membranous nephropathy , stimulation has been demonstrated to reduce podocyte injury and loss .
BACKGROUND	We hypothesized that H.P. Acthar ( ) Gel would improve symptoms of the nephrotic syndrome in patients with idiopathic membranous nephropathy .
METHODS	Twenty patients received a subcutaneous dose of 40 or 80 IU twice weekly .
METHODS	Changes in proteinuria , albumin , cholesterol profile , estimated glomerular filtration rate and serum anti-PLA2R antibodies were assessed at baseline and in response to treatment along with tolerance and safety .
RESULTS	Baseline characteristics included mean proteinuria ( 9.1 3.4 g/day ) , albumin ( 2.7 0.8 g/dL ) , estimated glomerular filtration rate ( 77 30 mL/min ) along with elevated total and low-density lipoprotein ( LDL ) cholesterol .
RESULTS	By 12 months of follow-up , there was a significant improvement in proteinuria in the entire cohort , decreasing to 3.87 4.24 g/day ( P < 0.001 ) with significant improvements in serum albumin , total and LDL cholesterol .
RESULTS	A > 50 % decrease in proteinuria was noted in 65 % of the patients with a trend toward better outcomes among patients who received greater cumulative doses .
RESULTS	No significant adverse effects were documented .
RESULTS	Clearing of serum anti-PLA2R antibodies prior to or in parallel with proteinuria improvement was noted in some , but not all patients .
CONCLUSIONS	H.P. Acthar ( ) Gel is a potential therapy for nephrotic syndrome secondary to idiopathic membranous nephropathy that deserves further study .

###24630869
BACKGROUND	The capsular polysaccharide of Salmonella enterica serovar Typhi , Vi antigen , is an essential virulence factor and a protective antigen .
BACKGROUND	Similar to other polysaccharide vaccines , the protective action of Vi , both to the polysaccharide alone or when presented as a conjugate , is mediated by serum IgG Vi antibodies .
BACKGROUND	The evaluation of Vi capsular polysaccharide based vaccines to prevent typhoid fever would be significantly facilitated by the identification of a `` protective level '' of serum antibodies to Vi antigen .
METHODS	The protective level of anti-Vi IgG against typhoid fever was derived from the protective efficacy and immune response of a Vi-rEPA conjugate vaccine efficacy trial .
METHODS	The estimation was derived by two methods : correlation of the percent efficacy and the antibody distribution profile in the vaccine group at a given period of observation , and use of the relative ratio of anti-Vi IgG levels between the vaccine and placebo groups greater or equal to the Relative Risk of typhoid fever used in the efficacy determination .
RESULTS	Both methods predicted a similar range of a minimum protective level of anti-Vi IgG between 1.4 and 2.0 g/ml ( short term threshold ) .
RESULTS	When applying a protective threshold of 10g/ml at 6 months post immunization , an IgG level in excess of 1.4 g/ml was achieved by 90 % of children at 46 months post immunization , consistent with an 89 % level of protection over the duration of the study .
RESULTS	We thus suggest that the proportion of children with Vi IgG > 10g/ml ( long term threshold ) 6 months after immunization may reflect the proportion protected over at least a 4 year period .
CONCLUSIONS	The current assignment of an anti-Vi IgG protective level may be of value when evaluating vaccine performance of future Vi conjugate vaccines .

###24626433
OBJECTIVE	Reducing LDL cholesterol ( LDL-C ) with statin-based therapy reduces the risk of major atherosclerotic events among patients with CKD , including dialysis patients , but the effect of lowering LDL-C on vascular access patency is unclear .
METHODS	The Study of Heart and Renal Protection ( SHARP ) randomized patients with CKD to 20 mg simvastatin plus 10 mg ezetimibe daily versus matching placebo .
METHODS	This study aimed to explore the effects of treatment on vascular access occlusive events , defined as any access revision procedure , access thrombosis , removal of an old dialysis access , or formation of new permanent dialysis access .
RESULTS	Among 2353 SHARP participants who had functioning vascular access at randomization , allocation to simvastatin plus ezetimibe resulted in a 13 % proportional reduction in vascular access occlusive events ( 355 [ 29.7 % ] for simvastatin/ezetimibe versus 388 [ 33.5 % ] for placebo ; risk ratio [ RR ] , 0.87 ; 95 % confidence interval [ 95 % CI ] , 0.75 to 1.00 ; P = 0.05 ) .
RESULTS	There was no evidence that the effects of treatment differed for any of the separate components of this outcome .
RESULTS	To test the hypothesis raised by SHARP , comparable analyses were performed using the AURORA ( A Study to Evaluate the Use of Rosuvastatin in Subjects on Regular Hemodialysis : An Assessment of Survival and Cardiovascular Events ) trial cohort .
RESULTS	AURORA did not provide independent confirmation ( vascular access occlusive events : 352 [ 28.9 % ] for rosuvastatin versus 337 [ 27.6 % ] for placebo ; RR , 1.06 , 95 % CI , 0.91 to 1.23 ; P = 0.44 ) .
RESULTS	After combining the two trials , the overall effect of reducing LDL-C with a statin-based regimen on vascular access occlusive events was not statistically significant ( 707 [ 29.3 % ] with any LDL-C-lowering therapy versus 725 [ 30.5 % ] with placebo ; RR , 0.95 , 95 % CI , 0.85 to 1.05 ; P = 0.29 ) .
CONCLUSIONS	Exploratory analyses from SHARP suggest that lowering LDL-C with statin-based therapy may improve vascular access patency , but there was no evidence of benefit in AURORA .
CONCLUSIONS	Taken together , the available evidence suggests that any benefits of lowering LDL-C on vascular access patency are likely to be modest .

###25629710
OBJECTIVE	Mobile smartphones are rapidly emerging as an effective means of communicating with many Americans .
OBJECTIVE	Using mobile applications ( apps ) , they can access remote databases , track time and location , and integrate user input to provide tailored health information .
OBJECTIVE	A smartphone mobile app providing personalized , real-time sun protection advice was evaluated in a randomized clinical trial .
METHODS	The trial was conducted in 2012 and had a randomized pretest-posttest controlled design with a 10-week follow-up .
METHODS	Data were collected from a nationwide population-based survey panel .
METHODS	A sample of 604 non-Hispanic and Hispanic adults from the Knowledge Panel 18 years or older who owned an Android smartphone were enrolled .
METHODS	The mobile app provided advice on sun protection ( ie , protection practices and risk of sunburn ) and alerts ( to apply or reapply sunscreen and get out of the sun ) , hourly UV Index , and vitamin D production based on the forecast UV Index , the phone 's time and location , and user input .
METHODS	Percentage of days using sun protection and time spent outdoors ( days and minutes ) in the midday sun and number of sunburns in the past 3 months were collected .
RESULTS	Individuals in the treatment group reported more shade use ( mean days staying in the shade , 41.0 % vs 33.7 % ; P = .03 ) but less sunscreen use ( mean days , 28.6 % vs 34.5 % ; P = .048 ) than controls .
RESULTS	There was no significant difference in number of sunburns in the past 3 months ( mean , 0.60 in the treatment group vs 0.62 for controls ; P = .87 ) .
RESULTS	Those who used the mobile app reported spending less time in the sun ( mean days keeping time in the sun to a minimum , 60.4 % for app users vs 49.3 % for nonusers ; P = .04 ) and using all protection behaviors combined more ( mean days , 39.4 % vs 33.8 % ; P = .04 ) .
CONCLUSIONS	The mobile app improved some sun protection .
CONCLUSIONS	Use of the mobile app was lower than expected but associated with increased sun protection .
CONCLUSIONS	Providing personalized advice when and where people are in the sun may help reduce sun exposure .

###24614628
OBJECTIVE	This study was carried out to examine the difference in effects between rosuvastatin and pravastatin on neointimal formation after the placement of a drug-eluting stent ( DES ) .
METHODS	Forty patients who underwent placement of a DES in our hospital were prospectively randomized to receive rosuvastatin ( n = 20 ) or pravastatin ( n = 20 ) , and analyzed by optical coherence tomography at the chronic stage .
METHODS	The main outcome measure was comparison of neointimal coverage analyzed at a strut level .
RESULTS	A significant reduction in total cholesterol , low-density lipoprotein , and white blood cell count was observed during the study in the rosuvastatin group ( total cholesterol , from 4.820.90 to 4.430.77 mmol/l , P = 0.038 ; low-density lipoprotein , from 2.850.76 to 2.340.57 mmol/l , P = 0.006 ; white blood cell count , from 58101399 to 53551257/l , P = 0.048 ) , but not in the pravastatin group .
RESULTS	Although not statistically significant , C-reactive protein was lower in the rosuvastatin than in the pravastatin group at the chronic stage ( 1.141.21 vs. 7.6713.67 mg/l , P = 0.051 ) .
RESULTS	Malapposed and uncovered struts were significantly less frequent in the rosuvastatin group than in the pravastatin group ( malapposed , 0.06 vs. 0.60 % , P < 0.001 ; uncovered , 6.49 vs. 11.29 % , P < 0.001 ) .
RESULTS	The difference in uncovered struts was maintained even when stent types were analyzed separately ( everolimus-eluting stent , 4.81 vs. 6.21 % , P = 0.007 ; sirolimus-eluting stent , 14.40 vs. 20.86 % , P < 0.001 ) .
RESULTS	Comparison of neointimal thickness between the rosuvastatin and the pravastatin groups showed inconsistent results depending on the stent types analyzed .
CONCLUSIONS	Compared with pravastatin , the use of rosuvastatin resulted in lower frequency of uncovered and malapposed struts after the placement of a DES , which might be mediated through improved inflammatory and lipid profiles .

###25547480
OBJECTIVE	The purpose of this study was to describe the unique characteristics of informal hospice cancer caregiving .
METHODS	Researchers conducted a secondary analysis of data drawn from a randomized clinical trial of an informal hospice caregiving intervention ( N = 348 ) .
METHODS	Demographic characteristics and measures of the informal caregiving experience of hospice patients and their informal caregivers were compared based on the patient 's diagnosis using chi-square tests for association of categorical variables and t tests for continuous variables .
RESULTS	Informal caregivers of cancer patients differed from their non-cancer counterparts in a number of respects including patient age , caregiver age , patient residence , relationship between patient and caregiver , amount and duration of care provided , likelihood to incur out-of-pocket expenses related to patient care , caregiver problem-solving style , and impact on caregiver daily schedule .
RESULTS	There were no statistically significant differences between cancer and non-cancer caregivers in terms of gender , race , employment status , anxiety , and quality of life .
CONCLUSIONS	While cancer and non-cancer caregivers are similar in many respects , a number of unique features characterize the informal hospice cancer caregiving experience .
CONCLUSIONS	Attention to these unique features will allow hospice providers to tailor supportive care interventions to better address cancer caregivers ' needs .

###25431346
BACKGROUND	Interest in improving care for the growing number of individuals with chronic conditions is rising .
BACKGROUND	However , access to care is limited by distance , disability , and distribution of doctors .
BACKGROUND	Small-scale studies in Parkinson disease , a prototypical chronic condition , have suggested that delivering care using video house calls is feasible , offers similar clinical outcomes to in-person care , and reduces travel burden .
METHODS	We are conducting a randomized comparative effectiveness study ( Connect.Parkinson ) comparing usual care in the community to usual care augmented by virtual house calls with a Parkinson disease specialist .
METHODS	Recruitment is completed centrally using online advertisements and emails and by contacting physicians , support groups , and allied health professionals .
METHODS	Efforts target areas with a high proportion of individuals not receiving care from neurologists .
METHODS	Approximately 200 individuals with Parkinson disease and their care partners will be enrolled at 20 centers throughout the United States and followed for one year .
METHODS	Participants receive educational materials , then are randomized in a 1:1 ratio to continue their usual care ( control arm ) or usual care and specialty care delivered virtually ( intervention arm ) .
METHODS	Care partners are surveyed about their time and travel burden and their perceived caregiver burden .
METHODS	Participants are evaluated via electronic survey forms and videoconferencing with a blinded independent rater at baseline and at 12 months .
METHODS	All study activities are completed remotely.The primary outcomes are : ( 1 ) feasibility , as measured by the proportion of visits completed , and ( 2 ) quality of life , as measured by the 39-item Parkinson 's Disease Questionnaire .
METHODS	Secondary outcomes include measures of clinical benefit , quality of care , time and travel burden , and caregiver burden .
CONCLUSIONS	Connect.Parkinson will evaluate the feasibility and effectiveness of using technology to deliver care into the homes of individuals with Parkinson disease .
CONCLUSIONS	The trial may serve as a model for increasing access and delivering patient-centered care at home for individuals with chronic conditions .
BACKGROUND	This trial was registered on clinicaltrials.gov on January 8 , 2014 [ NCT02038959 ] .

###25648379
BACKGROUND	Nitrous oxide anesthesia increases postoperative homocysteine concentrations .
BACKGROUND	Renal transplantation candidates present with higher homocysteine levels than patients with no renal disease .
BACKGROUND	We designed this study to investigate if homocysteine levels are higher in subjects receiving nitrous oxide for renal transplantation compared with subjects undergoing nitrous oxide free anesthesia .
METHODS	Data from 59 patients scheduled for living-related donor renal transplantation surgery were analyzed in this randomized , controlled , blinded , parallel-group , longitudinal trial .
METHODS	Patients were assigned to receive general anesthesia with ( flowmeter was set at 2 L/min nitrous oxide and 1 L/min oxygen ) or without nitrous oxide ( 2 L/min air and 1 L/min oxygen ) .
METHODS	We evaluated levels of total homocysteine and known determinants , including creatinine , folate , vitamin B12 , albumin , and lipids .
METHODS	We evaluated factor V and von Willebrand factor ( vWF ) to determine endothelial dysfunction and creatinine kinase myocardial band ( CKMB ) - mass , troponin T to show myocardial ischemia preoperatively in the holding area ( T1 ) , after discontinuation of anesthetic gases ( T2 ) , and 24 hours after induction ( T3 ) .
RESULTS	Compared with baseline , homocysteine concentrations significantly decreased both in the nitrous oxide ( 22.3 16.3 vs 11.8 9.9 ; P < .00001 ) and nitrous oxide-free groups ( 21.5 15.3 vs 8.0 5.7 ; P < .0001 ) at postoperative hour 24 .
RESULTS	The nitrous oxide group had significantly higher mean plasma homocysteine concentrations than the nitrous oxide-free group ( P = .021 ) .
RESULTS	The actual homocysteine difference between groups was 3.8 mol/L .
CONCLUSIONS	This study shows that homocysteine levels markedly decrease within 24 hours after living-related donor kidney transplantation .
CONCLUSIONS	Patients receiving nitrous oxide have a lesser reduction , but this finding is unlikely to have a clinical relevance .

###25133491
BACKGROUND	The effect of tranexamic acid ( TXA ) on bleeding and improvement of surgical field during functional endoscopic sinus surgery ( FESS ) is not clear yet .
BACKGROUND	This study was conducted to answer this question .
METHODS	This trial was conducted on 60 patients with chronic sinusitis at Beasat Hospital , Hamadan , Iran , from April to November 2013 .
METHODS	Thirty patients in the intervention group received three pledgets soaked with TXA 5 % and phenylephrine 0.5 % for 10 minutes in each nasal cavity before surgery .
METHODS	Thirty patients in the control group received phenylephrine 0.5 % with the same way .
METHODS	The amount of bleeding and the quality of surgical field were evaluated at 15 , 30 , and 45 minutes after the start of surgery using Boezaart grading .
RESULTS	The quality of the surgical field in the intervention group compared to the control group was significantly better in the first quarter ( P = 0.002 ) and the second quarter ( P = 0.003 ) but not in the third quarter ( P = 0.163 ) .
RESULTS	Furthermore , the amount of bleeding was much less during all periods in the intervention group than in the control group ( P = 0.001 ) .
CONCLUSIONS	Topical TXA can efficiently reduce bleeding and improve the surgical field in FESS in patients with rhinosinusitis .
CONCLUSIONS	Based on these findings , topical TXA may be a useful method for providing a suitable surgical field during the first 30 minutes after use .
BACKGROUND	Iranian Registry of Clinical Trials IRCT201212139014N15 .

###24684176
OBJECTIVE	The authors have reported in Part 1 of this study on a novel neuromonitoring test for the prevention of medial malpositioning of thoracic pedicle screws .
OBJECTIVE	In the present paper they examine the impact of providing the results of the test as intraoperative feedback to the surgical team .
METHODS	This is the second part of a 2-part report of a prospective , blinded and randomized neuromonitoring study designed to lower the incidence of medially malpositioned thoracic pedicle screws .
METHODS	Details of the neuromonitoring technique and data supporting the alarm criteria used are contained in the companion article ( Part 1 ) .
METHODS	For the majority of pedicle screw placements , intraoperative test results were withheld from the study team ( that is , the team members were blinded to the test results ) .
METHODS	However , for a limited number of pedicle sites the authors provided one of 2 forms of testing feedback to the surgical team : 1 ) `` break the blind '' feedback , if testing suggested that screw placement would result in direct contact between screw and the dura mater ; and 2 ) `` planned '' feedback , beginning during the later stages of the study and provided for 50 % of pedicle sites .
METHODS	Feedback gave the surgeon the opportunity to adjust the trajectory that the screw would ultimately take within the pedicle .
METHODS	The final screw position relative to the pedicle 's medial wall for all sites in which feedback was withheld from the surgical team was compared with the screw position for those sites in which either form of feedback ( `` break the blind '' or `` planned '' ) was provided to and acted upon by the surgical team .
RESULTS	Of the 820 pedicle tracks tested among the 71 surgical cases included in this study , a total of 684 were operated upon without any form of feedback .
RESULTS	Planned feedback was provided for an additional 107 pedicle tracks , of which 15 triggered an intraoperative alarm ( evoked electromyogram response in leg muscles to stimulus intensity 10 mA ) leading to a warning to the surgical team of a medially biased pedicle track .
RESULTS	Finally , the blind was broken 29 times , in each case when testing revealed a particularly low threshold ( 4 mA ) for evoked responses in leg muscles when stimulating along the pedicle track with the ball-tipped probe .
RESULTS	As detailed in the companion paper to this one , there were 32 screws with threads lying at least 2 mm medial to the pedicle wall .
RESULTS	In all 32 instances ( 100 % ) , either these screws were in the `` no feedback '' category ( n = 29 ) or they were in a feedback category but the surgeon elected to not revise the pedicle-track trajectory .
RESULTS	Two patients returned to the operating room for revision of screw placements because the screws were encroaching upon the central canal ; the pedicle tracks for these screws had been in the `` no feedback '' category .
CONCLUSIONS	This is the first blinded and randomized study to prove that implementing a novel neuromonitoring strategy during placement of thoracic pedicle screws can significantly reduce the incidence of clinically relevant thoracic pedicle screw medial malpositioning .

###24946464
OBJECTIVE	The aim of the present study was twofold : 1 .
OBJECTIVE	to compare the efficacy of three antipsychotics ( ziprasidone , olanzapine and perazine ) in schizophrenia 2 .
OBJECTIVE	to compare the improvement in cognitive functioning between groups treated with the three different neuroleptics .
METHODS	A total of 58 Caucasian patients diagnosed with paranoid schizophrenia were recruited into the study group .
METHODS	We used the Polish version of the CIDI ( Composite International Diagnostic Interview ) to obtain ICD-10 diagnoses .
METHODS	The intensity of psychopathological symptoms was examined using the PANSS .
METHODS	The patients were randomly assigned to treatment with perazine , olanzapine or ziprasidone administered as monotherapy for 3 months .
METHODS	The treatment efficacy was measured as a change in the PANSS ( Positive and Negative Syndrome Scale ) total score from baseline ( T0 ) to 3 months ( T1 ) .
METHODS	The WCST ( The Wisconsin Card Sorting Test ) was used to measure working memory and executive functions in the evaluated patients .
METHODS	Wilcoxon 's and Kruskal-Wallis tests were applied to compare changes in the PANSS scores between the treatment groups .
METHODS	To analyze the cognitive functions , Kruskal-Wallis test for the WCST parameters was used .
RESULTS	The three antipsychotics similarly reduced the total PANSS score .
RESULTS	The WCST parameters in the 3 groups of examined patients using the Kruskal-Wallis test revealed some differences between the three administered antipsychotics .
CONCLUSIONS	Results suggest that the short-term efficacy of the atypical ( olanzapine , ziprasidone ) and typical ( perazine ) antipsychotic drugs did not differ .
CONCLUSIONS	Based on the analysis , a conclusion can be drawn that the three neuroleptics provided similar improvements in cognitive functioning .

###24911175
BACKGROUND	Contextual factors , including the gender of researchers , influence experimental and patient pain reports .
BACKGROUND	It is currently not known how social stimuli influence pain percepts , nor which types of sensory modalities of communication , such as auditory , visual or olfactory cues associated with person perception and gender processing , produce these effects .
OBJECTIVE	To determine whether exposure to two forms of social stimuli ( audio and visual ) from a virtual male or female stranger modulates cold pressor task ( CPT ) pain reports .
METHODS	Participants with similar demographic characteristics conducted a CPT in solitude , without the physical presence of an experimenter or another person .
METHODS	During the CPT , participants were exposed to the voice and image of a virtual male or female stranger .
METHODS	The voices had analogous vocal prosody , provided no semantic information ( spoken in a foreign language ) and differed only in pitch ; the images depicted a middle-age male or female health care practitioner .
RESULTS	Male participants , but not females , showed higher CPT pain intensity when they were exposed to the female stimuli compared with the male stimuli .
RESULTS	Follow-up analyses showed that the association between the social stimuli and variability in pain sensitivity was not moderated by individual differences in subjective ( eg , self-image ) or objective measurements of one 's physical stature .
CONCLUSIONS	The findings show that exposure to virtual , gender-based auditory and visual social stimuli influences exogenous pain sensitivity .
CONCLUSIONS	Further research on how contextual factors , such as the vocal properties of health care examiners and exposure to background voices , may influence momentary pain perception is necessary for creating more standardized methods for measuring patient pain reports in clinical settings .

###24974855
OBJECTIVE	To compare early induction and expectant management regarding delivery outcomes and the experience of delivery in nulliparous women with prolonged latent phases .
METHODS	Randomized controlled trial .
METHODS	One delivery unit in a Swedish hospital .
METHODS	Nulliparous women at term experiencing continuous contractions impeding rest ( women 's report ) and exceeding 18 h , a cervical dilation of less than 4 cm , intact membranes and with a singleton fetus in cephalic presentation .
METHODS	The women were randomly allocated to either early induction ( n = 65 ) or expectant management ( n = 64 ) .
METHODS	All participants received medication for therapeutic rest .
METHODS	The early induction group was induced five hours after medication , and the expectant group awaited spontaneous onset of labor .
METHODS	The Wijma Delivery Experience Questionnaire ( W-DEQ version B ) was filled in after delivery .
METHODS	The primary outcome was mode of delivery .
METHODS	Secondary outcomes included birth experience , duration of labor , postpartum hemorrhage , and neonatal outcomes .
RESULTS	The cesarean section rate was 15 of 65 ( 23.1 % ) in the early induction group and 24 of 64 ( 37.5 % ) in the expectant group ( p = 0.076 , OR 2.00 , 95 % CI 0.93-4 .31 ) .
RESULTS	No significant differences were shown regarding delivery , neonatal outcomes or birth experience .
CONCLUSIONS	No significant differences were shown between the two groups in the rate of cesarean sections or the experience of delivery .
CONCLUSIONS	According to the actual results , the power to detect a difference was only 45 % .
CONCLUSIONS	The cesarean section rate was high in both groups , regardless of intervention .

###26054185
OBJECTIVE	A double blind , randomized , unsupervised , parallel-group clinical trial was conducted on over 5,500 children in Sichuan Province , China .
OBJECTIVE	This clinical trial compared the anti-caries efficacy of two test dentifrices to that of a control dentifrice .
METHODS	The test dentifrices contained 1.5 % arginine , 1450 ppm fluoride as sodium monofluorophosphate ( MFP ) , and an insoluble calcium compound ( either dicalcium phosphate or calcium carbonate ) .
METHODS	The positive control dentifrice contained 1450 ppm fluoride as sodium fluoride ( NaF ) , in a silica base .
METHODS	The children were randomly assigned one of the toothpastes , and children residing in the same household were assigned the same dentifrice to use at home , twice a day .
RESULTS	Three calibrated dentists examined the children at baseline , as well as after one and two years of product use .
RESULTS	After one year of product use , there were no statistically significant differences among the three groups with respect to decayed , missing , and filled teeth ( DMFT ) or to decayed , missing , and filled surfaces ( DMFS ) .
RESULTS	After two years of product use , subjects in the two test groups using the dentifrices containing 1.5 % arginine , 1450 ppm fluoride as MFP , and an insoluble calcium compound had a statistically significant reduction in DMFT increments of 20.5 % and in DMFS increments of 19.6 % when compared to subjects in the group using the positive control dentifrice .
RESULTS	After two years , there were no statistically significant differences with respect to DMFT or DMFS between the two groups using the dentifrices containing 1.5 % arginine , 1450 ppm fluoride as MFP , and an insoluble calcium compound .
CONCLUSIONS	The use of the two test dentifrices demonstrated significant reductions in decayed , missing , and filled teeth and surfaces , however there was no statistically significant different between the two test dentifrices clinically after two years of using the toothpastes .
CONCLUSIONS	The results of this two-year clinical investigation support the conclusion that dentifrices containing 1.5 % arginine , an insoluble calcium compound , and 1450 ppm fluoride as MFP provide superior protection against caries lesion cavitation compared to a positive control dentifrice containing only 1450 ppm fluoride as NaF .

###24356073
BACKGROUND	Although practice nurses are increasingly involved in hypertension management , there is little robust evidence of effectiveness .
OBJECTIVE	To evaluate the effect of a specialist nurse-led hypertension clinic with consultant backup on change in systolic blood pressure .
METHODS	Randomized trial .
METHODS	Two inner city general practices .
METHODS	Participants .
METHODS	Three hundred and fifty-three patients , mean age 62 years ( range 18-99 ) , with last recorded blood pressure British Hypertension Society audit standard were randomly allocated to the nurse-led clinic or usual care .
METHODS	Intervention .
METHODS	Patients received a letter informing them that their last blood pressure was over target and inviting them to the clinic .
METHODS	After assessment at the clinic , the nurse discussed any changes in anti-hypertensive treatment with a visiting consultant and the patient 's GP , and followed up the patient over 6 months until blood pressure targets were achieved .
METHODS	Reduction in systolic blood pressure , assessed using two audits of the practices ' computerized records where blood pressure was measured independently by practice staff before and after the intervention period .
RESULTS	Follow-up was 89 % ( 313/353 ) .
RESULTS	There was greater reduction in systolic blood pressure in the clinic group ( n = 144 ) than usual care group ( n = 169 , adjusted difference 4.4 mmHg ; 95 % CI 0.7 to 8.2 ) .
RESULTS	Of 167 patients randomly selected for the clinic , 91 ( 55 % ) attended , 49 had blood pressure above target when measured according to protocol and 26 had their anti-hypertensive treatment intensified by their GP .
CONCLUSIONS	Invitation to a specialist nurse-led hypertension clinic with consultant back up was associated with reduced systolic blood pressure .

###26021225
OBJECTIVE	To evaluate the difference between a single preoperative dose versus an additional two-day postoperative course of oral amoxicillin in patients undergoing conventional dental implant placement .
METHODS	Two dentists in two different private practices conducted this study .
METHODS	One hour prior to surgery , patients had to take a single prophylactic antibiotic dose , consisting of 2 g of amoxicillin orally ; after implant placement , patients were randomly allocated to two different groups : protocol A ( no other antibiotic administration ) and protocol B , ( 1 g of amoxicillin in the evening of the day of surgery and 1 g twice a day for the 2 days after ) .
METHODS	Outcome measures were prosthetic and implant failures , adverse events and early postoperative complications .
METHODS	Patients were followed up to 6 months after functional loading .
RESULTS	Three hundred and sixty patients were randomised and treated ( 192 patients in one centre and 168 in the other ) .
RESULTS	Five hundred and sixty-seven implants were placed .
RESULTS	Protocol A was applied to 180 patients ( 278 implants ) and protocol B also to 180 patients ( 289 implants ) .
RESULTS	Data for 17 patients , 14 from protocol A and three from protocol B , were not available .
RESULTS	No statistically significant differences were found for the reported outcomes .
RESULTS	Two patients of protocol B experienced a prosthetic failure , losing four implants , while no prosthetic failures were reported for protocol A ( P = 0.4836 ; difference in proportions = -0.0110 ; 95 % CI : -0.0412 to 0.0119 ) .
RESULTS	Five patients ( 3.0 % ) of protocol A lost five implants versus 5 patients ( 2.8 % ) who lost eight implants in protocol B ( P = 1.0000 ; difference in proportions = 0.0020 ; 95 % CI : -0.0384 to 0.0438 ) .
RESULTS	Three adverse events were observed in the total population , all occurring in protocol B ( 1.69 % ) , with no statistically significant differences between the two groups ( P = 0.1199 ; difference in proportions = -0.0170 ; 95 % CI : -0.0487 to 0.0059 ) .
RESULTS	However , one patient experienced a severe allergic reaction requiring therapy discontinuation and hospital admission .
RESULTS	Early postoperative complications occurred in six patients of protocol A and in four patients of protocol B , with no statistically significant differences ( P = 0.5170 ; difference in proportions = 0.0130 ; 95 % CI : -0.0254 to 0.0568 ) .
CONCLUSIONS	No statistically significant differences were observed between 2 g of preoperative amoxicillin and an additional 2-day postoperative course , although adverse events were reported only in the additional 2-day postoperative group .
CONCLUSIONS	Based on these findings , it might be sufficient to routinely administer preoperatively 2 g of amoxicillin to patients undergoing routine dental implant placement procedures rather than administering additional postoperative doses .

###25072610
BACKGROUND	Abnormal levels of CD8 T-cell activation persist in HIV-1-infected patients on suppressive antiretroviral therapy ( ART ) and may be deleterious .
METHODS	CD8 T-cell activation ( % coexpressing CD38/HLA-DR ) was analyzed on blood specimens from 833 HIV-1-infected patients on ART for 96 weeks with concurrent plasma HIV RNA ( vRNA ) 200 copies per milliliter .
METHODS	Factors associated with CD8 T-cell activation were assessed using generalized estimating equations to incorporate longitudinal measurements ( median 4/participant ) .
RESULTS	Participants were 84 % men , 47 % white , 28 % black , and 22 % Hispanic , with median pre-ART age 38 years and median ART exposure 144 weeks .
RESULTS	CD8 T-cell activation was higher at timepoints when vRNA was 51-200 versus 50 copies per milliliter [ mean CD8 T-cell activation 23.4 % vs. 19.7 % ; adjusted difference : 1.7 % ( 95 % confidence interval : 0.1 to 3.4 ) , P = 0.042 ] .
RESULTS	Restricting to vRNA 50 copies per milliliter , multivariable models showed the following factors associated with higher CD8 T-cell activation : older age [ 45 vs. 30 years : 3.6 % ( 1.4 to 5.7 ) , P = 0.004 ] , hepatitis C virus antibody positivity [ 3.6 % ( 0.9 to 6.2 ) , P = 0.032 ] , Hispanic vs. white [ 7.2 % ( 5.3 to 9.0 ) , P < 0.001 ] , lower concurrent CD4 count [ 200 vs. > 500 cells/mm : 2.2 % ( 0.7 to 3.7 ) , P < 0.001 ] , lower concurrent CD4/CD8 ratio [ -2.6 % ( -3.7 to -1.5 ) per 0.5 unit increase , P < 0.001 ] , and higher pre-ART CD8 T-cell activation [ 2.0 % ( 1.6 to 2.5 ) per 10 % higher , P < 0.001 ] .
CONCLUSIONS	In participants included in our analysis , residual low-level viremia between 51 and 200 copies per milliliter during ART was shown to be associated with greater CD8 T-cell activation than full suppression to < 50 copies per milliliter .
CONCLUSIONS	Older age , hepatitis C virus antibody positivity , race/ethnicity , higher pre-ART CD8 T-cell activation , and lower concurrent CD4/CD8 ratio and CD4 T-cell count also contribute to greater CD8 T-cell activation during suppressive ART .

###25117929
BACKGROUND	Antiretroviral therapy ( ART ) is associated with improved kidney function ; however , the nucleotide reverse transcriptase inhibitor ( NRTI ) tenofovir disoproxil fumarate ( TDF ) has been associated with decreased kidney function and proteinuria .
METHODS	We examined changes in urine protein : creatinine ( UPCR ) and urine albumin : creatinine ( UACR ) ratios in 245 ART-naive participants in A5202 randomized in a substudy to blinded NRTI ( abacavir/lamivudine , ABC/3TC , n = 124 or TDF/emtricitabine , TDF/FTC , n = 121 ) with open-label protease inhibitor ( PI ) atazanavir/ritonavir or nonnucleoside reverse transcriptase inhibitor ( NNRTI ) efavirenz .
RESULTS	At baseline , 18 % of participants had clinically significant proteinuria ( UPCR 200 mg/g ) , and 11 % had clinically significant albuminuria ( UACR 30 mg/g ) .
RESULTS	The prevalence of clinically significant proteinuria and albuminuria decreased from baseline to week 96 in all treatment groups .
RESULTS	In intention-to-treat analyses , there was a significant effect of NRTI component on fold change in UPCR ( P = 0.011 ) and UACR ( P = 0.018 ) from baseline to week 96 , with greater improvements in participants randomized to ABC/3TC .
RESULTS	There was no significant effect of NNRTI/PI component on fold change in UPCR ( P = 0.23 ) or UACR ( P = 0.88 ) , and no significant interactions between NRTI and NNRTI/PI components .
CONCLUSIONS	In this prespecified secondary analysis , ART initiation was associated with improvements in proteinuria and albuminuria , with significantly greater improvements in participants randomized to ABC/3TC versus TDF/FTC .
CONCLUSIONS	These are the first data from a randomized trial to suggest that initiation of TDF/FTC may not be associated with the same degree of improvement in proteinuria and albuminuria that have been reported with other regimens .
CONCLUSIONS	Future studies should consider the long-term clinical significance of these findings .

###24472156
BACKGROUND	This open-label , randomized study evaluated efficacy and safety of artemether-lumefantrine ( AL ) and dihydroartemisinin-piperaquine ( DP ) in treatment of uncomplicated falciparum malaria in children below five years of age , to build evidence on use of AL as first-line treatment and DP as second-line treatment in Kenya .
METHODS	A total of 454 children aged six to 59 months with uncomplicated falciparum malaria were randomized ( 1:1 ) to receive AL dispersible or DP paediatric tablets and followed up for 42 days .
METHODS	Primary efficacy variable was corrected adequate clinical and parasitological response ( ACPR ) rate on day 28 .
METHODS	Secondary variables included corrected ( day 14 , 28 and 42 ) , uncorrected ( day 3 , 14 , 28 and 42 ) cure rates , parasitological failure at days 3 , 14 and 42 .
METHODS	Acceptability and tolerability of both drugs were assessed by caregiver questionnaire .
RESULTS	On day 28 , corrected ACPR rates for AL dispersible and DP paediatric were 97.8 % ( 95 % CI : 94.9-99 .3 ) and 99.1 % ( 95 % CI : 96.8-99 .9 ) , respectively , in intention-to-treat population , with no significant treatment differences noted between AL dispersible and DP paediatric arms .
RESULTS	Additionally , no significant differences were observed for PCR corrected cure rates on days 14 and ACPR on day 42 for AL dispersible ( 100 % ; 96.8 % ) and DP paediatric ( 100 % ; 98.7 % ) .
RESULTS	Similarly , for PCR uncorrected cure rates , no significant differences were seen on days 3 , 14 , 28 , and 42 for AL dispersible ( 99.1 % ; 98.7 % ; 81.1 % ; 67.8 % ) and DP paediatric ( 100 % ; 100 % ; 87.7 % ; 70.5 % ) .
RESULTS	Parasite clearance was rapid , with approximately 90 % clearance achieved in 40 hours in both treatment arms .
RESULTS	Incidence of adverse events was related to underlying disease ; malaria being reported in both treatment arms .
RESULTS	One serious adverse event was noted in AL dispersible ( 0.42 % ) arm , not related to study drug .
RESULTS	Adherence to treatment regimen was higher for children treated with AL dispersible ( 93.6 % ) compared to DP paediatric ( 85.6 % ) .
RESULTS	Acceptability of AL dispersible regimen was assessed as being significantly better than DP paediatric .
CONCLUSIONS	AL and DP were both efficacious and well tolerated , and had similar effects at day 42 on risk of recurrent malaria .
CONCLUSIONS	No signs of Plasmodium falciparum tolerance to artemisinins were noted .
BACKGROUND	PACTR201111000316370 .

###24999127
BACKGROUND	Tracheostomy facilitates respiratory care and the process of weaning from mechanical ventilatory support .
OBJECTIVE	To compare the complications found in percutaneous dilatational tracheostomy ( PDT ) and surgical tracheostomy ( ST ) techniques .
METHODS	This was a prospective randomized study to evaluate the complications of PDT and ST procedures in patients admitted to ICU unit of a teaching hospital during 2008 to 2011 .
METHODS	We studied 40 patients in each group .
METHODS	PDTs were performed with blue rhino technique at the bedside by a skilled clinician and all cases of STs performed by Charles G Durbin technique in operating room under general anesthesia .
METHODS	Bronchoscopic examination through tracheostomy tube was performed to ensure the correct position of tracheostomy tube in the trachea lumen .
METHODS	The duration of procedures and pre - and post-interventional complications were recorded .
RESULTS	The most common complications observed in the PDT group were minor bleeding ( n = 4 ) , hypoxemia , and cardiac dysrhythmias ( n = 3 ) whereas in the ST group , the most frequent complications were minor bleeding ( n = 5 ) and endotracheal tube puncture ( n = 3 ) .
RESULTS	The difference in overall complications between the two groups was insignificant ( P = 0.12 ) .
CONCLUSIONS	PDT with blue rhino technique is a safe , quick , and effective method while the overall complications in both groups were comparable .

###25872465
OBJECTIVE	To assess the influence of the surgical removal of partially impacted third molars ( 3Ms ) and compare the effects of a 3-cornered laterally rotated flap ( LRF ) with primary closure ( flap 1 ) and an envelope flap with secondary closure ( flap 2 ) on the short-term periodontal status of the adjacent second molars ( 2Ms ) .
OBJECTIVE	We also assessed the postoperative complications after removal of the partially impacted 3M .
METHODS	A split mouth , randomized clinical study was designed .
METHODS	The study sample included patients with bilateral partially impacted 3Ms .
METHODS	The primary predictor variable was the type of flap design ( flaps 1 and 2 ) .
METHODS	The primary outcome variable was periodontal status ( gingival recession [ GR ] , probing depth [ PD ] , plaque index [ PI ] , and gingival index ) of the 2Ms measured preoperatively and 90 days postoperatively .
METHODS	The secondary outcome variables were postoperative complications , including pain , facial swelling , alveolitis , and local wound infection .
METHODS	The other variables included gender , position of the 3Ms , and surgical difficulty .
METHODS	We performed descriptive , comparative , correlation , and multivariate analyses .
RESULTS	The sample included 28 patients aged 18 to 28 years .
RESULTS	The GR , PD , and PI values with the flap 2 design were greater than those with the flap 1 design ( P < .05 ) .
RESULTS	Facial swelling with the flap 1 design was significantly greater than with the flap 2 design on the second postoperative day ( P < .05 ) .
RESULTS	The pain levels with the flap 1 design were significantly greater than those with the flap 2 design on the first and second postoperative days ( P < .05 ) .
RESULTS	According to the multivariate regression analyses , flap design was closely related to the periodontal status of the 2Ms and postoperative discomfort .
CONCLUSIONS	The results of the present clinical study have shown that the flap design in partially impacted 3M surgery considerably influences the early periodontal health of the 2Ms and postoperative discomfort .
CONCLUSIONS	However , although the 3-cornered LRF design might cause more pain and swelling , it could be the method of choice for partially impacted 3M surgery because of the early periodontal healing .

###24662864
BACKGROUND	Recent data suggest that intraoperative ( Phase I ) colloid ( human serum albumin [ HSA ] ) and a high fresh frozen plasma ( FFP ) / red blood cell ( RBC ) resuscitation will reduce postoperative ( Phase II ) fluid uptake .
BACKGROUND	This study compares a noncolloid ( balanced electrolyte solution [ BES ] ) plus low ( 0.35 ) FFP/RBC resuscitation ( Group A ) with an HSA plus high ( > 0.35 ) FFP/RBC resuscitation .
METHODS	A previous randomized study of 94 patients included 48 BES patients and 46 HSA patients .
METHODS	A Subgroup A of 25 BES patients with low FFP/RBC was compared with a Subgroup D of 21 HSA patients with high FFP/RBC .
METHODS	Parameters monitored included Phase I vital signs and resuscitation needs ; Phase II duration , BES needs , weight gain , and hourly urine output ; and postoperative plasma volume ( PV ) by radioiodinated serum albumin ( RISA ) , extracellular fluid ( ECF ) volume by inulin space , and interstitial volume by ECF-PV .
RESULTS	Admission pulse ( 132 for A vs. 133 for D ) , systolic blood pressure ( SBP ) ( 74 for A vs. 74 for D ) and Phase I shock time ( SBP < 80 Torr ; 25 for A vs. 35 for D ) were similar .
RESULTS	Phase I RBC needs ( 12.5 1.3 for A vs. 14.9 1.7 for D ) and BES needs ( 8.4 0.6 L for A vs. 8.4 0.6 L for D ) were similar .
RESULTS	During Phase II , D patients had more RBC , comparable BES , and weight gain , with lower hourly urine output compared with Group A patients .
CONCLUSIONS	HSA with high FFP/RBC does not prevent Phase II fluid uptake and causes lower urine output despite increased PV .
CONCLUSIONS	Colloid reduces glomerular filtration , increases tubular reabsorption , and increases ECF , thus , prolonging Phase II .
METHODS	Therapeutic study , level IV .

###24742662
OBJECTIVE	To compare two self-titration algorithms for initiating and escalating prandial insulin lispro in patients with type 2 diabetes inadequately controlled on basal insulin .
METHODS	The trial was designed as two independent , multinational , parallel , open-label studies ( A and B ) , identical in design , to provide substantial evidence of efficacy and safety in endocrine and generalist settings .
METHODS	Subjects were 18-85 years old ( study A : N = 528 ; study B : N = 578 ) , on basal insulin plus oral antidiabetic drugs for 3 months , and had an HbA1c 7.0 % to 12.0 % ( > 53.0 to 107.7 mmol/mol ) .
METHODS	Once optimized on insulin glargine , subjects were randomized to one of two self-titration algorithm groups adjusting lispro either every day ( Q1D ) or every 3 days ( Q3D ) for 24 weeks .
METHODS	The primary outcome was the change in HbA1c from baseline .
METHODS	The primary and secondary objectives were evaluated for the overall population and subjects 65 years old .
RESULTS	Baseline HbA1c was similar ( study A : Q1D 8.3 % [ 67.2 mmol/mol ] vs. Q3D 8.4 % [ 68.3 mmol/mol ] , P = 0.453 ; study B : Q1D 8.3 % [ 67.2 mmol/mol ] vs. Q3D 8.4 % [ 68.3 mmol/mol ] , P = 0.162 ) .
RESULTS	Both algorithms had significant and equivalent reductions in HbA1c from baseline ( study A : Q3D -0.96 % [ -10.49 mmol/mol ] , Q1D -1.00 % [ -10.93 mmol/mol ] , Q3D-Q1D 0.04 % [ 0.44 mmol/mol ] [ 95 % CI -0.15 to 0.22 ( -1.64 to 2.40 ) ] ; study B : Q3D -0.92 % [ -10.06 mmol/mol ] , Q1D -0.98 % [ -10.71 mmol/mol ] , Q3D-Q1D 0.06 % [ 0.66 mmol/mol ] [ 95 % CI -0.12 to 0.24 ( -1.31 to 2.62 ) ] ) .
RESULTS	The incidence and rate of hypoglycemia were similar for Q3D and Q1D in both studies .
RESULTS	In general , no clinically relevant differences were found between the two algorithms in subjects 65 years old in either study .
CONCLUSIONS	Prandial insulin lispro can effectively and safely be initiated , by either of two self-titrated algorithms , in a variety of practice settings .

###25078309
BACKGROUND	Interferon-free regimens are needed to treat hepatitis C virus ( HCV ) infections .
BACKGROUND	We investigated the efficacy of combined simeprevir and sofosbuvir .
METHODS	We enrolled patients with chronic HCV genotype 1 infections who had previously not responded to pegylated interferon ( peginterferon ) and ribavirin or were treatment naive .
METHODS	Patients were randomly assigned in a 2:1:2:1 ratio to receive 150 mg simeprevir and 400 mg sofosbuvir daily for 24 weeks with ( group 1 ) or without ( group 2 ) ribavirin or for 12 weeks with ( group 3 ) or without ( group 4 ) ribavirin , in two cohorts : previous non-responders with METAVIR scores F0-F2 ( cohort 1 ) and previous non-responders and treatment-naive patients with METAVIR scores F3-F4 ( cohort 2 ) .
METHODS	The primary endpoint was sustained virological response 12 weeks after stopping treatment ( SVR12 ) .
METHODS	Analysis was done by intention to treat .
METHODS	Safety data from cohorts 1 and 2 were pooled for analysis .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01466790 .
RESULTS	168 patients were enrolled and randomised , and 167 started treatment ( n = 80 in cohort 1 and n = 87 in cohort 2 ) .
RESULTS	SVR12 was achieved in 154 ( 92 % ) patients ( n = 72 [ 90 % , 95 % CI 81-96 ] in cohort 1 and n = 82 [ 94 % , 87-98 ] in cohort 2 ) .
RESULTS	The most common adverse events in the pooled groups were fatigue ( n = 52 [ 31 % ] ) , headache ( n = 33 [ 20 % ] ) , and nausea ( n = 26 [ 16 % ] ) .
RESULTS	Grade 4 adverse events were seen in one ( 2 % ) of 54 patients in each of groups 1 and 3 and in three ( 10 % ) of 31 patients in group 2 , whereas grade 3-4 events were reported in less than 5 % of all patients , except increased blood amylase concentration .
RESULTS	Serious adverse events were seen in four ( 2 % ) patients , all in groups 1 and 2 .
RESULTS	Four ( 2 % ) patients discontinued all study treatment because of adverse events , three before week 12 .
CONCLUSIONS	Combined simeprevir and sofosbuvir was efficacious and well tolerated .
BACKGROUND	Janssen .

###25342613
OBJECTIVE	We investigated the influences of the inner retinal sublayers and analytical areas in macular scans by spectral-domain optical coherence tomography ( OCT ) on the diagnostic ability of early glaucoma .
METHODS	A total of 64 early ( including 24 preperimetric ) glaucomatous and 40 normal eyes underwent macular and peripapillary retinal nerve fiber layer ( pRNFL ) scans ( 3D-OCT-2000 ) .
METHODS	The area under the receiver operating characteristics ( AUC ) for glaucoma diagnosis was determined from the average thickness of the total 100 grids ( 6 6 mm ) , central 44 grids ( 3.6 4.8 mm ) , and peripheral 56 grids ( outside of the 44 grids ) , and for each macular sublayer : macular RNFL ( mRNFL ) , ganglion cell layer plus inner plexiform layer ( GCL/IPL ) , and mRNFL plus GCL/IPL ( ganglion cell complex [ GCC ] ) .
METHODS	Correlation of OCT parameters with visual field parameters was evaluated by Spearman 's rank correlation coefficients ( rs ) .
RESULTS	The GCC-related parameters had a significantly larger AUC ( 0.82-0 .97 ) than GCL/IPL ( 0.81-0 .91 ) , mRNFL-related parameters ( 0.72-0 .94 ) , or average pRNFL ( 0.88 ) in more than half of all comparisons .
RESULTS	The central 44 grids had a significantly lower AUC than other analytical areas in GCC and mRNFL thickness .
RESULTS	Conversely , the peripheral 56 grids had a significantly lower AUC than the 100 grids in GCL/IPL inferior thickness .
RESULTS	Inferior thickness of GCC ( rs , 0.45-0 .49 ) and mRNFL ( rs , 0.43-0 .51 ) showed comparably high correlations with central visual field parameters to average pRNFL thickness ( rs , 0.41 , 0.47 ) even in the central 44 grids .
CONCLUSIONS	The diagnostic ability of macular OCT parameters for early glaucoma differed by inner retinal sublayers and also by the analytical areas studied .

###24940825
OBJECTIVE	Use of an injection site modulation device ( InsuPad ) in intensive insulin treatment reduces frequency of hypoglycemia and prandial insulin requirements by enhancing subcutaneous microcirculation .
OBJECTIVE	This meal tolerance test ( MTT ) investigation was performed as a sub-study during the real-world BARMER study to demonstrate non-inferiority of the reduced insulin doses observed in this study with respect to metabolic control .
METHODS	The MTT was performed at baseline and after 3 months in insulin treated diabetes patients using the modulation device vs. a control group without device .
METHODS	The dose used for the MTT was individually calculated based on the prandial insulin records from the patient diaries before the test .
METHODS	Blood was drawn for determination of glucose , insulin , C-peptide , proinsulin , triglycerides , free fatty acids , nitrotyrosine , and asymmetric dimethyl-arginine ( ADMA ) at multiple time-points from 0 to 300min .
METHODS	A total of 32 patients from one site were included into this MTT study ( 8 female , 7 type 1 diabetes , age : 49.912.5 yrs , HbA1c : 7.20.5 % ) .
RESULTS	During the BARMER study , mean HbA1c was treated to target ( < 6.5 % ) in both groups .
RESULTS	The prandial insulin dose decreased in the MTT modulation device group by -17.1 % , but remained unchanged in the control group ( -0.1 % , p < 0.001 ) .
RESULTS	No change was seen for the basal insulin dose in both treatment arms .
RESULTS	There were no differences between the groups with respect to the postprandial curves for glucose , C-peptide , intact proinsulin , free fatty acids , and triglycerides .
RESULTS	Insulin absorption was faster with the modulation device ( Tmax : 6028min vs. 9946min , p < 0.05 ) .
RESULTS	Key limitations are the small patient sample size and impossibility to determine the short-term effects of device use .
CONCLUSIONS	The results of this meal tolerance sub-study confirm that the observed prandial insulin dose reduction when using the injection site modulation device has no negative impact on postprandial metabolism .

###25716362
OBJECTIVE	This is the final report of a phase III randomized study to evaluate whole-brain radiotherapy ( WBRT ) in primary therapy of primary CNS lymphoma ( PCNSL ) after a median follow-up of 81.2 months .
METHODS	Patients with newly diagnosed PCNSL were randomized to high-dose methotrexate ( HDMTX ) - based chemotherapy alone or followed by WBRT .
METHODS	We hypothesized that the omission of WBRT would not compromise overall survival ( OS ; primary endpoint ) , using a noninferiority design with a margin of 0.9 .
RESULTS	In the per-protocol population ( n = 320 ) , WBRT nonsignificantly prolonged progression-free survival ( PFS ) ( median 18.2 vs 11.9 months , hazard ratio [ HR ] 0.83 [ 95 % confidence interval ( CI ) 0.65-1 .06 ] , p = 0.14 ) and significantly PFS from last HDMTX ( 25.5 vs 12.0 months , HR 0.65 [ 95 % CI 0.5-0 .83 ] , p = 0.001 ) , but without OS prolongation ( 35.6 vs 37.1 months , HR 1.03 [ 95 % CI 0.79-1 .35 ] , p = 0.82 ) .
RESULTS	In the intent-to-treat population ( n = 410 ) , there was a prolongation by WBRT of both PFS ( 15.4 vs 9.9 months , HR 0.79 [ 95 % CI 0.64-0 .98 ] , p = 0.034 ) and PFS from last HDMTX ( 19.4 vs 11.9 months , HR 0.72 [ 95 % CI 0.58-0 .89 ] , p = 0.003 ) , but not of OS ( 32.4 vs 36.1 months , HR 0.98 [ 95 % CI 0.79-1 .26 ] , p = 0.98 ) .
CONCLUSIONS	Although the statistical proof of noninferiority regarding OS was not given , our results suggest no worsening of OS without WBRT in primary therapy of PCNSL .
METHODS	This study provides Class II evidence that in PCNSL HDMTX-based chemotherapy followed by WBRT does not significantly increase survival compared to chemotherapy alone .
METHODS	The study lacked the precision to exclude an important survival benefit or harm from WBRT .

###24852464
BACKGROUND	The antimetabolite 5-fluorouracil ( 5-FU ) is used for topical treatment of actinic keratosis .
BACKGROUND	Overall improvement in the skin is also observed .
BACKGROUND	Additionally , 5-FU was reported to be used for superficial peels .
OBJECTIVE	To evaluate the efficacy and safety of 5 % 5-FU cream compared with peels for photodamaged forearms .
METHODS	This interventional , randomized , comparative , evaluator-blind study included 32 patients with severe photoaging of forearms .
METHODS	The regimens comprised either application of 5 % 5-FU cream everyday for 4 weeks on 1 forearm and 4 weekly peels on the other .
METHODS	Efficacy assessment included : clinical photodamage scores , opinion of patients and investigators , and blind photographic evaluation by independent observers .
METHODS	Skin biopsies were performed for histologic and immunohistochemical analysis .
METHODS	Safety evaluation comprised observation of adverse events .
RESULTS	Clinical and histologic findings confirmed the benefits of topical 5 % 5-FU , in cream or peels , which improved skin appearance and decreased the dermal elastotic material .
RESULTS	Immunohistochemistry showed reduced levels of epidermal p53 and increase in the level of procollagen I. Results were maintained after 6 months .
RESULTS	Predictable adverse events occurred , with no differences between treatments .
RESULTS	Patients reported better tolerability to peels .
CONCLUSIONS	Five percent 5-FU cream or peels was safe and effective for the treatment of photodamaged forearms .
CONCLUSIONS	Decreased epidermal p53 levels and new dermal collagen were confirmed .

###24824548
OBJECTIVE	We evaluate whether lifestyle and metformin interventions used to prevent diabetes have durable effects on markers of inflammation and coagulation and whether the effects are influenced by the development of diabetes .
METHODS	The Diabetes Prevention Program was a controlled clinical trial of 3,234 subjects at high risk for diabetes who were randomized to lifestyle , metformin , or placebo interventions for 3.4 years .
METHODS	Diabetes was diagnosed semiannually by fasting glucose and annually by oral glucose tolerance testing .
METHODS	In addition to baseline testing , anthropometry was performed every 6 months ; fasting insulin yearly ; and hs-CRP , tissue plasminogen activator ( tPA ) , and fibrinogen at 1 year and end of study ( EOS ) .
RESULTS	CRP and tPA levels were unchanged in the placebo group but fell in the lifestyle and metformin groups at 1 year and remained lower at EOS .
RESULTS	These reductions were not seen in those who developed diabetes over the course of the study despite intervention .
RESULTS	Fibrinogen was lower at 1 year in the lifestyle group .
RESULTS	Differences in weight and weight change explained most of the influence of diabetes on the CRP response in the lifestyle group , but only partly in the placebo and metformin groups .
RESULTS	Weight , insulin sensitivity , and hyperglycemia differences each accounted for the influence of diabetes on the tPA response .
CONCLUSIONS	Lifestyle and metformin interventions have durable effects to lower hs-CRP and tPA .
CONCLUSIONS	Incident diabetes prevented these improvements , and this was accounted for by differences in weight , insulin resistance , and glucose levels .

###24517082
OBJECTIVE	A single-agent , extended-release formulation of hydrocodone ( HC ) has been developed for treatment of chronic moderate-to-severe pain .
OBJECTIVE	This study was designed to examine the safety and efficacy of HC extended release in opioid-experienced adults with moderate-to-severe chronic low back pain ( CLBP ) .
METHODS	This multicenter , enriched enrollment , randomized withdrawal study comprised an open-label conversion/titration phase ( 6 weeks ) followed by placebo-controlled , double-blind treatment ( 12 weeks ) .
METHODS	During the conversion/titration phase , subjects ( N = 510 ) converted from their current opioid and were titrated to a stabilized dose of HC extended release ( 20-100mg every 12 hours ) .
METHODS	During treatment , subjects ( N = 151 per group ) received HC extended release or placebo ; rescue medication was permitted .
METHODS	The primary efficacy end point was mean change in average pain intensity from baseline to day 85 .
METHODS	Response rates ( 30 % pain improvement ) and satisfaction ( Subject Global Assessment of Medication ) were assessed .
RESULTS	Demographic and baseline characteristics were similar between groups .
RESULTS	MeanSD change in average pain intensity score from baseline to day 85 was significantly lower in the HC extended-release treatment group vs placebo ( 0.481.56 vs 0.961.55 ; P = 0.008 ) .
RESULTS	Significantly more responders were in the treatment group ( 68 % vs 31 % ; P < 0.001 ) .
RESULTS	Mean Subject Global Assessment of Medication scores increased significantly ( 0.81.3 vs 0.01.4 ; P < 0.0001 ) , indicating greater satisfaction with HC extended release .
RESULTS	The adverse event profile was consistent with other opioids .
CONCLUSIONS	Extended-release HC is well tolerated and effective , without acetaminophen-associated risks of liver toxicity , for treatment of CLBP .

###25142002
BACKGROUND	Ixmyelocel-T is associated with a wide range of biological activities relevant to tissue repair and regeneration .
OBJECTIVE	To evaluate the safety and efficacy of ixmyelocel-T in 2 prospective randomized phase 2A Trials administered via minithoracotomy or intramyocardial catheter injections in patients with dilated cardiomyopathy ( DCM ) stratified by ischemic or nonischemic status .
RESULTS	In IMPACT-DCM , patients were randomized to either ixmyelocel-T or standard-of-care control in a 3:1 ratio ( n = 39 ) ; ixmyelocel-T was administered intramyocardially via minithoracotomy .
RESULTS	In Catheter-DCM , patients were randomized to either ixmyelocel-T or standard of care control in a 2:1 ratio ( n = 22 ) ; ixmyelocel-T was administered intramyocardially using the NOGA Myostar catheter .
RESULTS	Only patients randomized to ixmyelocel-T underwent bone marrow aspiration and injections .
RESULTS	In the 2 studies , a total of 61 patients were randomized , and 59 were treated or received standard of care .
RESULTS	Fewer ischemic patients treated with ixmyelocel-T experienced a major adverse cardiovascular event during follow-up when compared with control patients .
RESULTS	A similar benefit was not seen in the nonischemic patients .
RESULTS	Heart failure exacerbation was the most common major adverse cardiovascular event .
RESULTS	Ixmyelocel-T treatment was associated with improved New York Heart Association class , 6-minute walk distance , and Minnesota Living with Heart Failure Questionnaire scores in the ischemic population relative to control ; a similar trend was not observed in the nonischemic population .
CONCLUSIONS	Intramyocardial injection with ixmyelocel-T reduces major adverse cardiovascular event and improves symptoms in patients with ischemic DCM but not in patients with nonischemic DCM .

###25847552
OBJECTIVE	To assess the effectiveness of OMT on chronic migraineurs using HIT-6 questionnaire , drug consumption , days of migraine , pain intensity and functional disability .
METHODS	3-Armed randomized controlled trial setting : all patients admitted in the Department of Neurology of Ancona 's United Hospitals , Italy , with a diagnosis of migraine and without chronic illness , were considered eligible for the study .
METHODS	Patients were randomly divided into three groups : ( 1 ) OMT + medication therapy , ( 2 ) sham + medication therapy and ( 3 ) medication therapy only .
METHODS	Patients received 8 treatments in a study period of 6 months .
METHODS	Changing from baseline HIT-6 score .
RESULTS	105 subjects were included .
RESULTS	At the end of the study , ANOVA showed that OMT significantly reduced HIT-6 score ( mean change scores OMT-conventional care : -8.74 ; 95 % confidence interval ( CI ) -12.96 to -4.52 ; p < 0.001 and OMT-sham : -6.62 ; 95 % CI -10.85 to -2.41 ; p < 0.001 ) , drug consumption ( OMT-sham : RR = 0.22 , 95 % CI 0.11-0 .40 ; OMT-control : RR = 0.20 , 95 % CI 0.10-0 .36 ) , days of migraine ( OMT-conventional care : M = -21.06 ; 95 % CI -23.19 to -18.92 ; p < 0.001 and OMT-sham : -17.43 ; 95 % CI -19.57 to -15.29 ; p < 0.001 ) , pain intensity ( OMT-sham : RR = 0.42 , 95 % CI 0.24-0 .69 ; OMT-control : RR = 0.31 , 95 % CI 0.19-0 .49 ) and functional disability ( p < 0.001 ) .
CONCLUSIONS	These findings suggest that OMT may be considered a valid procedure for the management of migraineurs .
CONCLUSIONS	The present trial was registered on www.ClinicalTrials.gov ( identifier : NCT01851148 ) .

###24667161
OBJECTIVE	The aim of this study was to assess the efficacy of strontium ranelate in improving symptoms in knee OA .
METHODS	Symptoms were assessed over 3 years in patients with primary knee OA receiving strontium ranelate 2 g/day ( n = 454 ) , 1 g/day ( n = 445 ) or placebo ( n = 472 ) in the Strontium Ranelate Efficacy in Knee Osteoarthritis Trial .
METHODS	Clinical response was evaluated using WOMAC subscores , minimal perceptible clinical improvement ( MPCI ) , minimal clinically important improvement ( MCII ) and a modified OMERACT-Osteoarthritis Research Society International ( OARSI ) responder definition .
METHODS	Patients who withdrew prematurely from the study were considered non-responders .
RESULTS	There was no significant effect on symptoms for strontium ranelate 1 g/day .
RESULTS	At the dosage of 2 g/day , strontium ranelate was associated with greater response than placebo in terms of 20 % improvement in WOMAC pain from baseline to the last visit ( 58 % vs 47 % , P = 0.002 ) and 50 % improvement in WOMAC pain ( 42 % vs 36 % , P = 0.083 ) .
RESULTS	Significant differences were found in MPCI response for WOMAC pain ( 52 % vs 40 % , P < 0.001 ) , stiffness ( 47 % vs 39 % , P = 0.009 ) and physical function ( 46 % vs 37 % , P = 0.009 ) and in MCII response for WOMAC physical function ( 46 % vs 37 % , P = 0.013 ) .
RESULTS	There were also more OMERACT-OARSI-like responders with strontium ranelate ( 44 % vs 35 % , P = 0.004 ) .
RESULTS	The treatment-placebo difference in MPCI response for WOMAC pain was significant after 6 months ( P = 0.024 ) , while that in MPCI and MCII response for WOMAC physical function reached significance after 12 months ( P = 0.027 and P = 0.019 , respectively ) .
CONCLUSIONS	Treatment with strontium ranelate 2 g/day over 3 years is associated with a clinically meaningful improvement in pain from 6 months as well as physical function and stiffness as assessed by the number of responders above thresholds of clinical relevance .
BACKGROUND	Current Controlled Trials .
BACKGROUND	http://www.controlled-trials.com/ ( ISRCTN41323372 ) .

###25867538
OBJECTIVE	Eighty-five percent of institutionalized elderly people have osteoporosis and bone fracture rates 8 to 9 times higher than rates observed among community-dwelling elderly people .
OBJECTIVE	Nevertheless , most of these persons are left untreated and are excluded from pivotal osteoporosis trials .
OBJECTIVE	To determine the efficacy and safety of zoledronic acid to treat osteoporosis in frail elderly women in long-term care facilities .
METHODS	We conducted a 2-year , randomized , placebo-controlled , double-blinded study from December 2007 through March 2012 .
METHODS	Included were 181 women 65 or older with osteoporosis , including those with cognitive impairment , immobility , and multimorbidity , who were living in nursing homes and assisted-living facilities .
METHODS	One 5-mg dose of zoledronic acid or placebo intravenously and daily calcium and vitamin D supplementation .
METHODS	Hip and spine bone mineral density ( BMD ) at 12 and 24 months and adverse events .
RESULTS	There were no baseline differences in mean ( SE ) age ( 85.4 [ 0.6 ] years ) , BMD , or functional or cognitive status , but the treatment group included more participants with frailty , falls history , diabetes , and anticonvulsant medication use .
RESULTS	Values for BMD were available for 87 % of participants at 12 months and 73 % at 24 months .
RESULTS	Mean ( SE ) BMD changes were greater in the treatment group : 3.2 ( 0.7 ) and 3.9 ( 0.7 ) percentage-point differences in the total hip at 12 and 24 months , respectively ( P < .01 for both comparisons ) , and 1.8 ( 0.7 ) and 3.6 ( 0.7 ) percentage-point differences at the spine ( P < .01 ) ; adjusted analyses were similar .
RESULTS	The treatment and placebo groups ' fracture rates were 20 % and 16 % , respectively ( OR , 1.30 ; 95 % CI , 0.61-2 .78 ) ; mortality rates were 16 % and 13 % ( OR , 1.24 ; 95 % CI , 0.54-2 .86 ) .
RESULTS	Groups did not differ in the proportion of single fallers ( 28 % vs 24 % ; OR , 1.24 ; 95 % CI , 0.64-2 .42 ; P = .52 ) , but more participants in the treatment group had multiple falls ( 49 % vs 35 % ; OR , 1.83 ; 95 % CI , 1.01-3 .33 ; P = .047 ) ; however , this difference was no longer significant when adjusted for baseline frailty .
CONCLUSIONS	In this group of frail elderly women with osteoporosis , 1 dose of zoledronic acid improved BMD over 2 years .
CONCLUSIONS	The clinical importance of nonsignificant increases in fracture and mortality rates in the treatment group needs further study .
CONCLUSIONS	Since it is not known whether such therapy reduces the risk of fracture in this cohort , any change in nursing home practice must await results of larger trials powered to assess fracture rates .
BACKGROUND	clinicaltrials.gov Identifier : NCT00558012 .

###25391190
BACKGROUND	Nutrition is an important aspect in the care of very low birth weight ( VLBW ) preterm infants .
BACKGROUND	Human milk fortified with human milk fortifiers ( HMF ) is best for enteral feeding of premature infants .
BACKGROUND	HMF is expensive and not easily available in Thailand .
BACKGROUND	Post discharge formula ( PDF ) has been routinely used to fortify human milk at Queen Sirikit National Institute of Child Health ( QSNICH ) but there is lack of supportive data regarding efficacy and safety .
OBJECTIVE	To study and compare anthropometrics , biochemical markers and complications in VLBW infants fed human milk fortified with either HMF or PDF .
METHODS	This was a prospective , randomized pilot study conducted in the neonatal unit of QSNICH from 1 March 2010 to 28 February 2011 .
METHODS	Very low birth weight neonates , whose mothers had adequate breast milk within 96 hours of birth , were enrolled in the study and received parenteral nutrition and enteral feeding as per protocol .
METHODS	Once the babies were feeding 100 cc/kg/day of human milk , they were randomly divided into two groups : the human milk fortified group ( HMF group ) and the post discharge formula fortified group ( PDF group ) .
METHODS	Body weight was recorded daily while head circumference and length were recorded weekly .
METHODS	Hematocrit , Blood Urea Nitrogen ( BUN ) , creatinine , electrolytes ( including phosphorus and calcium ) , alkaline phosphatase and albumin were checked at the beginning of the study ( feeding 100 cc/kg/day ) , 3 weeks later and when on full oral breast feeding or reached a weight of 2,000 grams , which ever came first .
RESULTS	Thirty-eight infants were enrolled in the study but eventually only 33 remained ( 18 in HMF group , 15 in PDF group ) .
RESULTS	Both groups had similar baseline demographic data , nutritional management , postnatal morbidities and length of stay .
RESULTS	There were no statistically significant differences in growth parameters and serum biochemical markers between the groups .
RESULTS	Definite NEC was not different between the groups .
RESULTS	Other complications of prematurity including osteopenia of prematurity were similar in both the groups .
RESULTS	The cost of breast milk fortification per person in the PDF and HMF group was 605 and 11,655 baht , respectively .
CONCLUSIONS	Human milk fortifiers are best for fortification of human milk in VLBW babies but using PDF as a fortifier may be considered as an alternative for VLBW infant in resource limited , developing countries .
CONCLUSIONS	However , it should always be additionally supplemented with multivitamins especially vitamin D , iron , calcium and phosphorus .
CONCLUSIONS	Complications like feeding intolerances and suspected NEC should be monitored closely .
CONCLUSIONS	Larger studies focusing on short and long-term outcomes are needed in the future .

###25468616
OBJECTIVE	Based on current evidence , there is a little agreement on the best timing for after birth umbilical cord clamping .
OBJECTIVE	This study was designed to compare the impact of using two different times for cord clamping on hematocrit concentration and Apgar scores of the neonate .
METHODS	Fifty-six healthy full-term vaginally born neonates were allocated to early ( 10 seconds after delivery ) and late ( 3 minutes after delivery ) umbilical cord clamping groups in this randomized clinical trial .
METHODS	We recorded the length of the 3rd stage of labor and Apgar score at 5 minutes .
METHODS	Infant 's hematocrit was measured at 2 and 18 hours of age .
RESULTS	Neonatal hematocrit differed between the two groups .
RESULTS	Late cord clamping group had greater hematocrit at 2 hours ( 45.5 4 vs. 49.5 4.4 , P = 0.0003 ) and 18 hours ( 47.7 5.5 vs. 52.9 4.3 , P = 0.0002 ) .
RESULTS	Apgar scores at 5 minutes ( 9.3 0.6 vs. 9.4 0.6 , p = 0.5 ) and duration of delivery 3rd stage ( 10.2 3.7 min vs. 8.9 5 min , P = 0.2 ) did not differ between early and late cord clamping groups respectively .
CONCLUSIONS	Late cord clamping leads to a significant increase in the hematocrit of the neonate but it does not have effects on Apgar score and duration of the 3rd stage of labor .

###24745634
BACKGROUND	Unintentional injury is a leading cause of infant mortality .
OBJECTIVE	To examine the role of caregiver health literacy in infant injury prevention behaviors .
METHODS	A cross-sectional analysis of data collected in 2010-2012 from a randomized trial at four pediatric clinics was performed in 2012-2013 .
METHODS	Caregiver health literacy was assessed with the Short Test of Functional Health Literacy in Adults .
METHODS	Caregiver-reported adherence to American Academy of Pediatrics-recommended injury prevention behaviors was assessed across seven domains : ( 1 ) car seat position ; ( 2 ) car seat use ; ( 3 ) sleeping safety ; ( 4 ) fire safety ; ( 5 ) hot water safety ; ( 6 ) fall prevention ; and ( 7 ) firearm safety .
RESULTS	Data were analyzed from 844 English - and Spanish-speaking caregivers of 2-month-old children .
RESULTS	Many caregivers were non-adherent with injury prevention guidelines , regardless of health literacy .
RESULTS	Notably , 42.6 % inappropriately placed their children in the prone position to sleep , and 88.6 % did not have their hot water heater set < 120F .
RESULTS	Eleven percent of caregivers were categorized as having low health literacy .
RESULTS	Low caregiver health literacy , compared to adequate health literacy , was significantly associated with increased odds of caregiver non-adherence with recommended behaviors for car seat position ( AOR = 3.4 , 95 % CI = 1.6 , 7.1 ) and fire safety ( AOR = 2.0 , 95 % CI = 1.02 , 4.1 ) recommendations .
RESULTS	Caregivers with low health literacy were less likely to be non-adherent to fall prevention recommendations ( AOR = 0.5 , 95 % CI = 0.2 , 0.9 ) .
CONCLUSIONS	Non-adherence to injury prevention guidelines was common .
CONCLUSIONS	Low caregiver health literacy was significantly associated with some injury prevention behaviors .
CONCLUSIONS	Future interventions should consider the role of health literacy in promoting injury prevention .

###25853743
BACKGROUND	During primary percutaneous coronary intervention ( PCI ) , manual thrombectomy may reduce distal embolization and thus improve microvascular perfusion .
BACKGROUND	Small trials have suggested that thrombectomy improves surrogate and clinical outcomes , but a larger trial has reported conflicting results .
METHODS	We randomly assigned 10,732 patients with ST-segment elevation myocardial infarction ( STEMI ) undergoing primary PCI to a strategy of routine upfront manual thrombectomy versus PCI alone .
METHODS	The primary outcome was a composite of death from cardiovascular causes , recurrent myocardial infarction , cardiogenic shock , or New York Heart Association ( NYHA ) class IV heart failure within 180 days .
METHODS	The key safety outcome was stroke within 30 days .
RESULTS	The primary outcome occurred in 347 of 5033 patients ( 6.9 % ) in the thrombectomy group versus 351 of 5030 patients ( 7.0 % ) in the PCI-alone group ( hazard ratio in the thrombectomy group , 0.99 ; 95 % confidence interval [ CI ] , 0.85 to 1.15 ; P = 0.86 ) .
RESULTS	The rates of cardiovascular death ( 3.1 % with thrombectomy vs. 3.5 % with PCI alone ; hazard ratio , 0.90 ; 95 % CI , 0.73 to 1.12 ; P = 0.34 ) and the primary outcome plus stent thrombosis or target-vessel revascularization ( 9.9 % vs. 9.8 % ; hazard ratio , 1.00 ; 95 % CI , 0.89 to 1.14 ; P = 0.95 ) were also similar .
RESULTS	Stroke within 30 days occurred in 33 patients ( 0.7 % ) in the thrombectomy group versus 16 patients ( 0.3 % ) in the PCI-alone group ( hazard ratio , 2.06 ; 95 % CI , 1.13 to 3.75 ; P = 0.02 ) .
CONCLUSIONS	In patients with STEMI who were undergoing primary PCI , routine manual thrombectomy , as compared with PCI alone , did not reduce the risk of cardiovascular death , recurrent myocardial infarction , cardiogenic shock , or NYHA class IV heart failure within 180 days but was associated with an increased rate of stroke within 30 days .
CONCLUSIONS	( Funded by Medtronic and the Canadian Institutes of Health Research ; TOTAL ClinicalTrials.gov number , NCT01149044 . )

###25236873
OBJECTIVE	Expert consensus guidelines recommend low-density lipoprotein cholesterol as the primary serum lipid target for recurrent stroke risk reduction .
OBJECTIVE	However , mounting evidence suggests that other lipid parameters might be additional therapeutic targets or at least also predict cardiovascular risk .
OBJECTIVE	Little is known about the effects of nontraditional lipid variables on recurrent stroke risk .
METHODS	We analyzed the Vitamin Intervention for Stroke Prevention study database comprising 3680 recent ( < 120 days ) noncardioembolic stroke patients followed up for 2 years .
METHODS	Independent associations of baseline serum lipid variables with recurrent ischemic stroke ( primary outcome ) and the composite end point of ischemic stroke/coronary heart disease/vascular death ( secondary outcomes ) were assessed .
RESULTS	Of all variables evaluated , only triglycerides/high-density lipoprotein cholesterol ( HDL-C ) ratio was consistently and independently related to both outcomes : compared with the lowest quintile , the highest triglycerides/HDL-C ratio quintile was associated with stroke ( adjusted hazard ratio , 1.56 ; 95 % confidence interval , 1.05-2 .32 ) and stroke/coronary heart disease/vascular death ( 1.39 ; 1.05-1 .83 ) , including adjustment for lipid modifier use .
RESULTS	Compared with the lowest quintile , the highest total cholesterol/HDL-C ratio quintile was associated with stroke/coronary heart disease/vascular death ( 1.45 ; 1.03-2 .03 ) .
RESULTS	Low-density lipoprotein cholesterol/HDL-C ratio , non-HDL-C , elevated triglycerides alone , and low HDL-C alone were not independently linked to either outcome .
CONCLUSIONS	Of various nontraditional lipid variables , elevated baseline triglycerides/HDL-C and total cholesterol/HDL-C ratios predict future vascular risk after a stroke , but only elevated triglycerides/HDL-C ratio is related to risk of recurrent stroke .
CONCLUSIONS	Future studies should assess the role of triglycerides/HDL-C as a potential therapeutic target for global vascular risk reduction after stroke .

###24495406
OBJECTIVE	There are no randomized clinical trials regarding efficacy of trazodone in the treatment of sleep disturbances ( SD ) in patients with Alzheimer disease ( AD ) .
OBJECTIVE	We tested the efficacy and safety of trazodone to treat SD in patients with AD .
METHODS	We conducted a double-blind , randomized and controlled trial during periods of 7-9 days at baseline and 2 weeks of treatment .
METHODS	Geriatric medical center of the university 's general hospital .
METHODS	Individuals with probable AD and SD .
METHODS	The complete analysis comprised 30 patients assigned to either the active treatment group ( N = 15 ) or the placebo group ( N = 15 ) .
METHODS	Patients received 50 mg of trazodone once daily at 10:00 P.M. or placebo in a 1:1 ratio for 2 weeks .
METHODS	Patients were evaluated using actigraphy and structured scales before and after intervention .
RESULTS	Compared with the placebo group , trazodone users slept 42.5 more minutes per night and had their nighttime percent sleep increased 8.5 percentage points according to actigraphic data post-treatment .
RESULTS	Neither trazodone nor placebo induced significant daytime sleepiness or naps .
RESULTS	The treatments with trazodone or placebo did not show any effects either on cognition ( Mini-Mental State Examination , forward/backward digit span task , letter-number sequencing , arithmetic , digit symbol-coding , and symbol search ) or functionality ( Katz index ) .
RESULTS	There were no differences in frequency or severity rating of adverse events between the groups .
CONCLUSIONS	This study shows significant therapeutic effects of trazodone 50 mg in community-dwelling AD patients with SD .

###25011421
BACKGROUND	Despite rising international rates of obesity , men remain reluctant to participate in weight loss research .
BACKGROUND	There is a lack of evidence to guide the development of effective weight loss interventions that engage men .
BACKGROUND	The objective of this study was to provide a comprehensive process evaluation of the SHED-IT ( Self-Help , Exercise and Diet using Information Technology ) weight loss program for men , as delivered in the SHED-IT community weight loss trial , and to identify key components associated with success .
METHODS	In an assessor-blinded randomised controlled trial , 159 overweight and obese men ( BMI 25.0-40 .0 kg/m2 ) were randomised to one of two gender-tailored weight loss interventions with no face-to-face contact , or a control group .
METHODS	The interventions were informed by Bandura 's Social Cognitive Theory ( SCT ) with men encouraged to complete a Support Book containing SCT-based tasks including goal setting , reward setting , creation of social support strategies and self-monitoring of : i ) weight , ii ) physical activity , and iii ) diet .
METHODS	At post-test , compliance with SCT tasks was examined and men also completed a process evaluation questionnaire .
RESULTS	Both SHED-IT intervention groups demonstrated greater weight loss during the intervention compared to the control , with no difference between intervention groups .
RESULTS	Most men engaged with the SCT tasks although compliance declined over time and utilisation of social support networks and reward selection was poor .
RESULTS	In a multiple regression model , the number of goals set ( [ 95 % CI ] = -0.3 [ -0.6 , -0.1 ] , p = 0.01 ) and the number of weight records documented ( [ 95 % CI ] = -0.2 [ -0.4 , -0.0 ] , p = 0.03 ) independently predicted weight loss .
RESULTS	The process evaluation indicated that men found the programs to be supportive , enjoyable and beneficial .
CONCLUSIONS	This process evaluation provides valuable information to inform the development of obesity treatment strategies that engage men .
CONCLUSIONS	Future studies with men should include a strong focus on self-monitoring and goal setting to enhance behaviour change and improve treatment effects .
BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12610000699066 .

###25011935
BACKGROUND	Hepatocellular carcinoma ( HCC ) risk-scores may predict HCC in Asian entecavir ( ETV ) - treated patients .
BACKGROUND	We aimed to study risk factors and performance of risk scores during ETV treatment in an ethnically diverse Western population .
METHODS	We studied all HBV monoinfected patients treated with ETV from 11 European referral centres within the VIRGIL Network .
RESULTS	A total of 744 patients were included ; 42 % Caucasian , 29 % Asian , 19 % other , 10 % unknown .
RESULTS	At baseline , 164 patients ( 22 % ) had cirrhosis .
RESULTS	During a median follow-up of 167 ( IQR 82-212 ) weeks , 14 patients developed HCC of whom nine ( 64 % ) had cirrhosis at baseline .
RESULTS	The 5-year cumulative incidence rate of HCC was 2.1 % for non-cirrhotic and 10.9 % for cirrhotic patients ( p < 0.001 ) .
RESULTS	HCC incidence was higher in older patients ( p < 0.001 ) and patients with lower baseline platelet counts ( p = 0.02 ) .
RESULTS	Twelve patients who developed HCC achieved virologic response ( HBV DNA < 80IU/mL ) before HCC .
RESULTS	At baseline , higher CU-HCC and GAG-HCC , but not REACH-B scores were associated with development of HCC .
RESULTS	Discriminatory performance of HCC risk scores was low , with sensitivity ranging from 18 % to 73 % , and c-statistics from 0.71 to 0.85 .
RESULTS	Performance was further reduced in Caucasians with c-statistics from 0.54 to 0.74 .
RESULTS	Predicted risk of HCC based on risk-scores declined during ETV therapy ( all p < 0.001 ) , but predictive performances after 1year were comparable to those at baseline .
CONCLUSIONS	Cumulative incidence of HCC is low in patients treated with ETV , but ETV does not eliminate the risk of HCC .
CONCLUSIONS	Discriminatory performance of HCC risk scores was limited , particularly in Caucasians , at baseline and during therapy .

###24589725
OBJECTIVE	To measure the effects of an HIV-Care-Program , focusing on nutrition and lifestyle , which can be provided at scale to HIV-infected patients , on clinical and anthropometrical parameters , and health status .
METHODS	A cluster-randomized trial , including 5 health facilities randomized to intervention n = 100 ( HIV-Care-Program ) or control n = 101 ( Usual-Care ) .
METHODS	The HIV-Care-Program consisted of counseling lessons for 6 months , on : nutrition , hygiene , coping with stigma and discrimination , embedded in practical activities .
METHODS	Outcome variables were CD4 count after 6 months and time to antiretroviral therapy ( ARV ) initiation , using analysis of covariance and Kaplan-Meier method , respectively .
RESULTS	After 6 months , CD4 count dropped by 46.3 cells ( 7.7 % ) ( intervention ) and 129 ( 23 % ) ( control ) ( p = 0.003 ) .
RESULTS	Mean time to ARV ; 5.9 months 95 % CI ( 5.9 , 6.0 ) ( intervention ) ; 4.9 months 95 % CI ( 4.7 , 5.2 ) ( control ) ( p < 0.004 ) .
RESULTS	There was a partial correlation between CD4 count and initial viral load ( r = -0.190 , p = 0.017 ) .
CONCLUSIONS	The intervention provides a low-cost alternative improving health status , slowing down CD4 cell decline , delaying initiation of ARV and thus freeing local ARV capacities for patients in urgent need .

###25415158
OBJECTIVE	To test the association between docosahexaenoic acid ( DHA ) supplementation and perceived stress and cortisol response to a stressor during pregnancy in a sample of African American women living in low-income environments .
METHODS	Sixty-four African American women were enrolled at 16-21 weeks of gestation .
METHODS	Power calculations were computed using published standard deviations for the Perceived Stress Scale and the Trier Social Stress Test .
METHODS	Participants were randomized to either 450 mg per day of DHA ( n = 43 ) or placebo ( n = 21 ) .
METHODS	At baseline and at 24 and 30 weeks of gestation , perceived stress was assessed by self-report .
METHODS	Cortisol response to a controlled stressor , the Trier Social Stress Test was measured from saliva samples collected upon arrival to the laboratory and after the completion of the Trier Social Stress Test .
RESULTS	Women in the DHA supplementation group reported lower levels of perceived stress at 30 weeks of gestation , controlling for depression and negative life events ( mean 27.4 compared with 29.5 , F [ 3 , 47 ] 5.06 , P = .029 , Cohen 's d = 0.65 ) .
RESULTS	Women in the DHA supplementation had lower cortisol output in response to arriving to the laboratory and a more modulated response to the stressor ( F [ 1.78 , 83.85 ] 6.24 , P = .004 , Cohen 's d = 0.76 ) .
CONCLUSIONS	Pregnant women living in urban low-income environments who received DHA reported reduced perceived stress and lower levels of stress hormones in the third trimester .
CONCLUSIONS	Docosahexaenoic acid supplementation may be a method for attenuating the effects of maternal stress during late pregnancy and improving the uterine environment with regard to fetal exposure to glucocorticoids .
BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT01158976 .

###24220254
OBJECTIVE	The objective of this study was to evaluate the performance of digital subtraction angiography ( DSA ) - like bone subtraction with 2 different registration methods for the identification of bone marrow edema pattern ( BMEP ) in patients with lytic bone lesions , using magnetic resonance imaging as the criterion standard .
METHODS	Fifty-five patients with a lytic bone lesion were included in this prospective study with approval from the ethics committee .
METHODS	All patients underwent magnetic resonance imaging and low-dose computed tomographic ( CT ) perfusion after signing an informed consent .
METHODS	Two CT volumes were used for bone subtraction , which was performed with 2 different algorithms ( rigid and nonrigid ) .
METHODS	Enhancement at the nonlytic bone marrow was considered as a sign of BMEP .
METHODS	Two readers evaluated the images blindly .
METHODS	The presence of BMEP on bone-subtracted CT images was evaluated subjectively and quantitatively .
METHODS	Image quality was assessed .
METHODS	Magnetic resonance imaging was used as the criterion standard .
RESULTS	Using a rigid registration method , the sensitivity , specificity , positive predictive value , negative predictive value , and accuracy of CT with DSA-like bone subtraction BMEP was 77 % , 100 % , 100 % , 68 % , and 85 % , respectively .
RESULTS	The interobserver agreement was good ( , 0.782 ) .
RESULTS	Image quality was better using a nonrigid registration .
RESULTS	With this algorithm , artifacts interfered with image interpretation in only 5 % of cases .
RESULTS	However , there was a noticeable drop in sensitivity and negative predictive value when a nonrigid algorithm was used : 56 % and 52 % , respectively .
RESULTS	The interobserver agreement was average with a nonrigid subtraction algorithm .
CONCLUSIONS	Computed tomography with DSA-like bone subtraction is sensitive and highly specific for the identification of BMEP associated with lytic bone lesions .
CONCLUSIONS	Rigid registering should be preferred , but nonrigid algorithms can be used as a second option when artifacts interfere with image interpretation .

###24691606
OBJECTIVE	Tadalafil is used to treat erectile dysfunction after prostate cancer treatment , but its role as a preventive agent is undefined .
OBJECTIVE	To determine primarily whether tadalafil preserved erectile function in men treated with radiotherapy for prostate cancer , and secondarily to determine whether participant - or partner-reported overall sexual function and sexual and marital satisfaction were affected .
METHODS	Stratified , placebo-controlled , double-blind , parallel-group study with 1:1 randomization at 76 community-based and tertiary medical sites in the United States and Canada .
METHODS	Two hundred forty-two participants with intact erectile function scheduled to receive radiotherapy for prostate cancer were recruited between November 2009 and February 2012 with follow-up through March 2013 .
METHODS	One hundred twenty-one participants were assigned 5 mg of tadalafil daily and 121 were assigned placebo for 24 weeks starting with external radiotherapy ( 63 % ) or brachytherapy ( 37 % ) .
METHODS	Participant-reported International Index of Erectile Function response before radiotherapy and at weeks 2 and 4 , between weeks 20 and 24 , between weeks 28 and 30 , and 1 year thereafter .
METHODS	Participants and partners could respond also to the Sexual Adjustment Questionnaire and to the Locke Marital Adjustment Test before radiotherapy , between weeks 20 and 24 and weeks 28 and 30 , and at 1 year .
METHODS	Primary outcome was off-drug spontaneous erectile function 28 to 30 weeks after radiotherapy started .
METHODS	Secondary end points were spontaneous erection at 1 year ; overall sexual function and satisfaction ; marital adjustment ; and partner-reported satisfaction and marital adjustment at 28 to 30 weeks and 1 year , predictors of tadalafil response ; and adverse events .
RESULTS	Among 221 evaluable participants , 80 ( 79 % ; 95 % CI , 70 % -88 % ) assigned to receive tadalafil retained erectile function between weeks 28 and 30 compared with 61 ( 74 % ; 95 % CI , 63 % -85 % ) assigned to receive placebo ( P = .49 ) ; an absolute difference of 5 % ( 95 % CI , -9 % to 19 % ) .
RESULTS	A significant difference was also not observed at 1 year ( 72 % ; 95 % CI , 60 % -84 % vs 71 % ; 95 % CI , 59 % -84 % ; P = .93 ) .
RESULTS	Tadalafil was not associated with significantly improved overall sexual function or satisfaction ; a significant difference was not observed in any domain subscale .
RESULTS	Partners of men assigned tadalafil noted no significant effect on sexual satisfaction , and marital adjustment was not significantly improved in participants or partners .
CONCLUSIONS	Among men undergoing radiotherapy for prostate cancer , daily use of tadalafil compared with placebo did not result in improved erectile function .
CONCLUSIONS	These findings do not support daily use of tadalafil to prevent erectile dysfunction in these patients .
BACKGROUND	clinicaltrials.gov Identifier : NCT00931528 .

###25772920
OBJECTIVE	This study investigated the effect of a re-wetting agent on the microtensile bond strengths ( mTBS ) of primary and permanent dentin after acid or laser etching .
METHODS	Twelve permanent and 12 primary molar teeth were ground to expose an occlusal dentin surface .
METHODS	Each group teeth were randomly divided into groups ; I-II : 37 % phosphoric acid etching with/without re-wetting agent , III-IV : Erbium : Yttrium aluminium garnet laser etching with/without re-wetting agent .
METHODS	An etch-and-rinse adhesive was used , and vertical sticks were obtained for the microtensile test .
RESULTS	mTBS of permanent teeth was higher than that of primary teeth ( P < 0.05 ) .
RESULTS	Re-wetting agent groups were similar with control groups in both etching groups in the permanent teeth ( P > 0.05 ) .
RESULTS	Re-wetting agent group was similar with the control group in acid etch group ( P > 0.05 ) and lower than the control group in laser etch group in primary teeth ( P < 0.05 ) .
CONCLUSIONS	Acid etching in permanent teeth ; laser etching in primary teeth was found more successful .
CONCLUSIONS	The use of re-wetting agent did not provide an advance on bond strength of the adhesive in both primary and permanent teeth after acid-etch or laser-etch .

###24351113
BACKGROUND	Evidence based practice ( EBP ) requires that health professionals are competent in integrating the best evidence in their decision making .
BACKGROUND	Being ` evidence-based ' requires skills and knowledge in epidemiology , biostatistics and information literacy .
BACKGROUND	EBP is commonly taught in medical and health sciences degrees , yet there is little evidence to guide educators as to the best teaching modality to increase learner competency in EBP .
METHODS	This study is mixed methods in design .
METHODS	A randomised controlled trial will examine the effectiveness of blended learning versus didactic approach of teaching EBP to medical students .
METHODS	The primary outcome of the RCT is EBP competency as assessed by the Berlin tool .
METHODS	Focus groups will be conducted to explore student perceptions and attitudes towards implementing a blended learning approach in teaching EBP .
METHODS	A concurrent triangulation design will be implemented , permitting quantitative data to inform the effectiveness of the intervention and qualitative data to contextualise the results .
CONCLUSIONS	This study will provide novel evidence on the effectiveness of blended learning in teaching EBP to a cohort of undergraduate and graduate-entry medical students .

###25170676
BACKGROUND	There is currently little evidence regarding the selection of patients for clinical trials in Parkinson 's Disease ( PD ) , especially those involving experimental therapies delivered using invasive techniques .
OBJECTIVE	Understanding which patients are recruited will increase awareness of issues regarding parity of access to clinical trials and have an impact on the wider applicability of results , as well as provoking discussion regarding future improvements in the enrolment process .
METHODS	TRANSEURO is an open label multi-centre surgical transplant trial which seeks to investigate the feasibility and efficacy of grafts of human foetal ventral mesencephalic tissue in patients with PD .
METHODS	The Cambridge based cohort of TRANSEURO participants ( n = 26 ) was compared with a population representative sample of patients with PD eligible for , but not enrolled in , TRANSEURO ( n = 33 ) .
METHODS	Measurements were available in both populations for demographics , neuropsychological tests , tests of motor and non-motor function and quality of life .
RESULTS	Patients enrolled in TRANSEURO were younger and had significantly more years of education with higher scores on the revised Addenbrooke 's Cognitive Examination .
RESULTS	This difference was accounted for by memory , fluency and visuospatial subscores .
RESULTS	There were significant differences in the Movement Disorder Society Unified PD Rating Scale scores with better motor function but more motor complications in the enrolled group .
RESULTS	Those enrolled were also more likely to be under the care of the principal investigator of the study .
CONCLUSIONS	In this trial our population was younger and more educated with higher cognitive scores and better motor function than eligible PD patients not enrolled .
CONCLUSIONS	This raises interesting questions about the parity of access to clinical trials of this nature amongst patients with PD .

###24886232
BACKGROUND	Little is known about the type of care older people of different ages receive at the end of life .
BACKGROUND	The goal of treatment is an important parameter of the quality of end-of-life care .
BACKGROUND	This study aims to provide an evaluation of the main goal of treatment in the last week of life of people aged 86 and older compared with those between 75 and 85 and to examine how treatment goals are associated with age .
METHODS	Population - based cross sectional survey in Flanders , Belgium .
METHODS	A stratified random sample of death certificates was drawn of people who died between 1 June and 30 November 2007 .
METHODS	The effective study sample included 3,623 deaths ( response rate : 58.4 % ) .
METHODS	Non-sudden deaths of patients aged 75 years and older were selected ( N = 1681 ) .
METHODS	Main outcome was the main goal of treatment in the last week of life ( palliative care or life-prolonging/curative treatment ) .
RESULTS	In patients older than 75 , the main goal of treatment in the last week was in the majority of cases palliative care ( 77.9 % ) .
RESULTS	Patients between 75 and 85 more often received life-prolonging/curative treatment than older patients ( 26.6 % vs. 15.8 % ) .
RESULTS	Most patient and health care characteristics are similarly related to the main goal of treatment in both age groups .
RESULTS	The patient 's age was independently related to having comfort care as the main goal of treatment .
RESULTS	The main goal of treatment was also independently associated with the patient 's sex , cause and place of death and the time already in treatment .
CONCLUSIONS	Age is independently related to the main goal of treatment in the last week of life with people over 85 being more likely to receive palliative care and less likely to receive curative/life-prolonging treatment compared with those aged 75-85 .
CONCLUSIONS	This difference could be due to the patient 's wishes but could also be the result of the attitudes of care givers towards the treatment of older people .

###25431052
OBJECTIVE	To investigate baricitinib ( LY3009104 , formerly INCB028050 ) , a novel , oral inhibitor of JAK1/JAK2 in patients with moderate to severe rheumatoid arthritis ( RA ) despite treatment with methotrexate .
METHODS	In this phase IIb study , 301 patients were randomised 2:1:1:1:1 to receive once daily doses of placebo or 1 , 2 , 4 or 8mg baricitinib for 12weeks .
METHODS	Patients assigned to 2 , 4 and 8 mg baricitinib continued blinded treatment for an additional 12weeks .
METHODS	Patients assigned to placebo or 1 mg baricitinib were reassigned to 2 mg twice daily or 4 mg once daily baricitinib between weeks 12-24 .
METHODS	The primary endpoint was the proportion of patients in the combined 4 and 8 mg groups achieving an American College of Rheumatology 20 % ( ACR20 ) response versus placebo at week 12 .
RESULTS	Significantly more patients in the combined baricitinib 4 and 8 mg groups compared with placebo achieved an ACR20 response at week 12 ( 76 % vs 41 % , p < 0.001 ) .
RESULTS	At week 12 , significant differences versus placebo were also observed in patients achieving ACR50 , ACR70 and remission as measured by Disease Activity Score for 28-joint counts , Clinical Disease Activity Index and Simplified Disease Activity Index .
RESULTS	Patients receiving 2 , 4 , or 8mg baricitinib maintained or improved in all measures through 24weeks .
RESULTS	Similar proportions of patients experienced at least one adverse event in the placebo and baricitinib groups .
RESULTS	Serious infections developed in three patients receiving baricitinib .
RESULTS	No cases of tuberculosis , herpes zoster , opportunistic infections or deaths were reported .
RESULTS	Dose-dependent decreases in haemoglobin were observed with baricitinib .
CONCLUSIONS	Baricitinib improved the signs and symptoms of RA in methotrexate inadequate responders with active disease .
CONCLUSIONS	Baricitinib was well tolerated with no unexpected safety findings through week 24 .
BACKGROUND	NCT01185353 .

###24763866
OBJECTIVE	Modern immunosuppressant regimens have significantly decreased acute rejection rates , but may have increased the risk of graft loss driven by adverse drug reactions ( ADRs ) and medication errors ( MEs ) .
OBJECTIVE	The objectives of this study were to determine the incidence and risk factors for MEs and ADRs and determine the association between transplant outcomes and these events .
METHODS	This was a post hoc analysis of a prospective , randomized trial that included patients aged > 18 years that received a solitary renal transplant at an academic medical center recruited between March 2009 and July 2011 .
METHODS	Patients were divided into groups based on developing a clinical significant ME ( CSME ) , defined as a significant ME that contributed to a hospital admission .
RESULTS	The mean study follow-up was 2.5 0.7 years .
RESULTS	There were a total of 233 MEs and 327 ADRs in the 200 patients included in the analysis , with 64 % of the cohort experiencing at least one ME and 87 % experiencing an ADR ; 23 patients ( 12 % ) experienced a CSME .
RESULTS	Patients that experienced CSMEs had a trend toward more post-transplant readmissions ( median 1 [ interquartile range ( IQR ) , 0-5 ] versus 0 [ 0-2 ] ; P = 0.06 ) , higher costs for readmissions ( median $ 18,091 [ IQR , $ 3023 - $ 56,268 ] versus $ 0 [ $ 0 - $ 15,991 ] ; P < 0.01 ) , and overall length of stay ( median 5.0 days [ IQR , 2.0-14 .0 ] versus 0.0 days [ IQR , 0.0-5 .5 ] ; P < 0.01 ) after the CSME event .
RESULTS	CSME patients were also more likely to experience graft failure ( 22 % versus 10 % ; P = 0.05 ) .
CONCLUSIONS	Significant MEs commonly occur in renal transplant recipients and are associated with an increased risk of deleterious clinical outcomes , including subsequent hospital days , costs , and graft loss .

###24279296
BACKGROUND	In order to improve lung cancer survival in the UK , a greater proportion of resectable cancers must be diagnosed .
BACKGROUND	It is likely that resectability rates would be increased by more timely diagnosis .
BACKGROUND	Aside from screening , the only way of achieving this is to reduce the time to diagnosis in symptomatic cancers .
BACKGROUND	Currently , lung cancers are mainly diagnosed by general practitioners ( GPs ) using the National Institute for Health and Clinical Excellence ( NICE ) guidelines for urgent referral for chest X-ray , which recommend urgent imaging or referral for patients who have one of a number of chest symptoms for more than 3 weeks .
BACKGROUND	We are proposing to expand this recommendation to include one of a number of chest symptoms of any duration in higher-risk patients .
METHODS	We intend to conduct a trial of imaging in these higher-risk patients and compare it with NICE guidelines to see if imaging improves stage at diagnosis and resection rates .
METHODS	This trial would have to be large ( and consequently resource-intensive ) because most of these patients will not have lung cancer , making optimal design crucial .
METHODS	We are therefore conducting a pilot trial that will ascertain the feasibility of running a full trial and provide key information that will be required in order to design the full trial .
CONCLUSIONS	This trial will assess the feasibility and inform the design of a large , UK-wide , clinical trial of a change to the NICE guidelines for urgent referral for chest X-ray for suspected lung cancer .
CONCLUSIONS	It utilizes a combination of workshop , health economic , quality of life , qualitative , and quantitative methods in order to fully assess feasibility .
BACKGROUND	Clinicaltrials.gov NCT01344005 .

###24447534
BACKGROUND	Sildenafil citrate is indicated for the treatment of erectile dysfunction .
BACKGROUND	An orally disintegrating tablet ( ODT ) of sildenafil citrate has been developed for the benefit of patients who have difficulty swallowing solid dosage forms .
OBJECTIVE	The main goal of this study was to evaluate the bioequivalence of sildenafil ODT with and without water versus marketed sildenafil oral film-coated tablets .
OBJECTIVE	A secondary objective was to evaluate the effects of a high-fat meal on the pharmacokinetics of sildenafil ODT .
METHODS	The bioequivalence study of sildenafil ODT given with and without water versus marketed sildenafil citrate film-coated oral tablets was conducted in 36 subjects .
METHODS	In a food-effect study , the effect of a standard high-fat meal on the pharmacokinetics of sildenafil ODT was evaluated in 12 subjects .
METHODS	Both studies were randomized , open-label , crossover , single-dose ( 50 mg ) studies in healthy men aged 45 years .
METHODS	Plasma samples were collected for 14 hours postdose , and pharmacokinetics were determined by using noncompartmental analyses .
RESULTS	All subjects in both studies were Asian males between the ages of 45 and 69 years .
RESULTS	Sildenafil ODT without water was bioequivalent to the marketed sildenafil film-coated oral tablet as the 90 % CI for the ratio of geometric means of Cmax , AUC0 - , and AUC0-last were contained within equivalence limits ( 80 % -125 % ) .
RESULTS	When sildenafil ODTs were given with water , the 90 % CIs for sildenafil AUC0 - and AUC0-last were contained within the range of 80 % to 125 % ; however , the 90 % CI for sildenafil Cmax was not ( 79.76-92 .78 ) .
RESULTS	This difference in Cmax is unlikely to have any clinically meaningful impact .
RESULTS	High-fat meals reduced the rate but not the extent of absorption of sildenafil .
RESULTS	Mean Cmax was reduced by 59 % , and median Tmax was delayed from 0.625 hour ( fasting ) to 4 hours ( high-fat meal ) .
RESULTS	However , AUC values were comparable between fed and fasted treatments .
CONCLUSIONS	Sildenafil ODT , given with or without water , provides equivalent systemic exposure compared with marketed sildenafil film-coated oral tablets , thus offering a convenient alternative method of administration .
CONCLUSIONS	Considering the results of the food-effect study , sildenafil ODT should be taken on an empty stomach .
CONCLUSIONS	ClinicalTrials.gov identifiers : NCT01254383 ( bioequivalence ) and NCT01254396 ( food effect ) .

###24432350
BACKGROUND	Facial responses to pain are believed to be an act of communication and , as such , are likely to be affected by the relationship between sender and receiver .
OBJECTIVE	To investigate this effect by examining the impact that variations in communicative relations ( from being alone to being with an intimate other ) have on the elements of the facial language used to communicate pain ( types of facial responses ) , and on the degree of facial expressiveness .
METHODS	Facial responses of 126 healthy participants to phasic heat pain were assessed in three different social situations : alone , but aware of video recording ; in the presence of an experimenter ; and in the presence of an intimate other .
METHODS	Furthermore , pain catastrophizing and sex ( of participant and experimenter ) were considered as additional influences .
RESULTS	Whereas similar types of facial responses were elicited independent of the relationship between sender and observer , the degree of facial expressiveness varied significantly , with increased expressiveness occurring in the presence of the partner .
RESULTS	Interestingly , being with an experimenter decreased facial expressiveness only in women .
RESULTS	Pain catastrophizing and the sex of the experimenter exhibited no substantial influence on facial responses .
CONCLUSIONS	Variations in communicative relations had no effect on the elements of the facial pain language .
CONCLUSIONS	The degree of facial expressiveness , however , was adapted to the relationship between sender and observer .
CONCLUSIONS	Individuals suppressed their facial communication of pain toward unfamiliar persons , whereas they overtly displayed it in the presence of an intimate other .
CONCLUSIONS	Furthermore , when confronted with an unfamiliar person , different situational demands appeared to apply for both sexes .

###25640411
OBJECTIVE	To assess the incidence and progression of macular atrophy and other key anatomic outcomes over 7 to 8 years in an early cohort of ranibizumab-treated exudative age-related macular degeneration patients .
METHODS	Follow-up analysis of long-term outcomes in a multicenter treatment cohort .
METHODS	Fourteen study sites enrolled 65 previous subjects from the ranibizumab treatment arms of the ANCHOR , MARINA , and HORIZON trials .
METHODS	In a single update visit , clinical assessment and retinal imaging studies were performed , with comparison with each subject 's prior results from the previous trials .
METHODS	Early Treatment Diabetic Retinopathy Study visual acuity was the primary outcome .
METHODS	Secondary outcomes , including area of macular atrophy and selected anatomic factors , were analyzed for associations with long-term vision outcomes .
RESULTS	At a mean 7.3 years after ANCHOR or MARINA enrollment , mean visual acuity was 54 letters , study eyes having received a mean 1.6 injections per year since the HORIZON study .
RESULTS	Macular atrophy was present in 98 % of study eyes , the mean area increasing from 0.83 0.96 mm ( 2 ) at the ANCHOR or MARINA year 2 exit to 2.22 1.6 mm ( 2 ) at the SEVEN-UP visit , a growth rate of 0.28 mm ( 2 ) / year .
RESULTS	Progression of macular atrophy was associated significantly with visual decline over this 5-year period ( P < .001 ) , and final macular atrophy lesion size was related significantly to final vision ( P < .001 ) .
RESULTS	Other key anatomic outcomes ( macular thickening , thinning , or fluid and submacular fibrosis ) did not have significant effects on vision outcomes .
CONCLUSIONS	Seven years after initiation of intensive ranibizumab therapy for exudative age-related macular degeneration , macular atrophy progression and severity were the primary anatomic determinants of visual outcomes .

###24625936
BACKGROUND	Poisoning with organophosphorus ( OP ) compounds constitutes a global public health problem .
BACKGROUND	Standard treatment of OP poisoning involves use of atropine and pralidoxime .
BACKGROUND	While efficacy of atropine is well-established , clinical experience with pralidoxime in management of OP poisoning is controversial .
OBJECTIVE	To explore the efficacy of add-on pralidoxime with atropine over atropine alone in the management of OP poisoning .
METHODS	An open-label , parallel-group , randomized clinical trial was conducted in a tertiary care district hospital in West Bengal .
METHODS	Patients presenting with features of OP poisoning were randomly allocated to receive atropine or atropine-plus-pralidoxime .
METHODS	Efficacy was assessed by analyzing mortality , requirement for ventilator support and the duration of stay in hospital .
METHODS	Chi-square test was done to compare the efficacy parameters between the two groups .
METHODS	A two-tailed P-value < 0.05 was considered as statistically significant .
RESULTS	During the study period , 150 patients were screened following which 120 patients were randomized to either of the treatment arms .
RESULTS	Add-on pralidoxime therapy did not offer any appreciable benefit over atropine alone in terms of reducing mortality ( 18.33 % ( 11/60 ) versus 13.33 % ( 8/60 ) ) and ventilator requirement ( 5 % ( 3/60 ) versus 8.33 % ( 5/60 ) ) .
RESULTS	However , patients randomized in the add-on pralidoxime arm experienced longer duration of hospital stay ( 7.02 1.12 days ) than those receiving atropine-alone therapy ( 5.68 1.87 days ) ( P < 0.001 ) .
CONCLUSIONS	The present study suggested that add-on pralidoxime with atropine therapy did not offer any appreciable benefit over atropine alone in management of OP poisoning .
CONCLUSIONS	However , further trials are needed to explore different dosing regimens of pralidoxime in order to determine its efficacy in OP poisoning .

###24372612
BACKGROUND	Inflammatory markers show significant associations with cardiovascular events and all-cause mortality after kidney transplantation .
BACKGROUND	Neopterin , reflecting interferon -- release , may better reflect the proinflammatory state of recipients than less specific markers .
METHODS	Kidney transplant recipients in the Assessment of LEscol in Renal Transplant ( ALERT ) trial were examined and investigated for an association between serum neopterin and subsequent clinical events : graft loss , major cardiovascular events ( MACE ) and all-cause mortality .
RESULTS	After adjustment for established and emerging risk factors neopterin expressed as neopterin-to-creatinine ratio was significantly associated with MACE ( p = 0.009 ) and all-cause mortality ( p = 0.002 ) .
RESULTS	Endpoints were more frequent with increasing quartiles of neopterin-to-creatinine ratio .
RESULTS	The incidence rates of MACE and all-cause mortality were significantly increased in the upper quartiles compared with the first .
CONCLUSIONS	This long-term prospective analysis in stable kidney allograft recipients suggests that neopterin is associated with long-term risk of cardiovascular events and all-cause mortality , but not renal outcomes .

###24755130
OBJECTIVE	Acute pain can lead to immune dysfunction , which can be partly ameliorated by successful pain management .
OBJECTIVE	Opioids , which are widely used for analgesia , can result in the deterioration of immune function .
OBJECTIVE	This study aimed to investigate the influence of morphine with or without flurbiprofen as post-operative analgesics on the immune systems of patients undergoing gastric cancer surgery .
METHODS	60 patients undergoing gastric cancer surgery were equally randomized into two groups .
METHODS	They received post-operative patient-controlled intravenous ( IV ) analgesia using morphine either with or without flurbiprofen .
METHODS	Visual analogue scale ( VAS ) scores , Bruggemann comfort scale ( BCS ) scores , morphine consumption , time of first flatus , incidence of nausea/vomiting , and T-lymphocyte subsets ( CD3 , CD4 , and CD8 ) and natural killer cells ( CD3CD16CD56 ) were evaluated .
RESULTS	No significant difference was observed in the VAS scores , BCS scores , and nausea/vomiting incidence between groups .
RESULTS	Less morphine was consumed and the time of first flatus was earlier in patients receiving morphine with flurbiprofen than morphine alone .
RESULTS	The expression of CD3 , CD4 , CD4/CD8 , and CD3CD16CD56 decreased at 2 hours after incision and , except for CD3CD16CD56 , returned to baseline at 120 hours after surgery .
RESULTS	Moreover , the expression of CD3CD16CD56 at 2 hours after incision and the expression of CD3 , CD4 , CD4/CD8 , and CD3CD16CD56 at 24 hours after surgery were higher in patients receiving morphine with flurbiprofen than morphine alone .
CONCLUSIONS	The combination of morphine and flurbiprofen ameliorates the immune depression in Tlymphocyte subsets and natural killer cells and provides a similar analgesic efficacy to morphine alone in patients undergoing gastric cancer surgery .

###25835231
BACKGROUND	Vitamin C has important physical and mental health benefits and plasma concentrations reflect recent intakes .
BACKGROUND	Inflammation associated with any acute illness can lead to poor appetite and low food intake in older people .
BACKGROUND	The aims of this report were to assess the prevalence and clinical significance of vitamin C deficiency among hospitalized acutely-ill older patients .
METHODS	Three hundred and twenty two patients ( 152 [ 47 % ] female ) , aged 65 yrs .
METHODS	and over who took part in a randomized , double blind , placebo-controlled trial had their nutritional status assessed from anthropometric , hematological and biochemical data at baseline , and after 6 weeks and 6 months .
METHODS	Vitamin C was measured using a fluorimetric technique and logistic regression analysis was performed to determine the influence of a number of clinical indicators , including tissue inflammation measured using C-reactive protein on vitamin C concentrations .
METHODS	Clinical outcome measures including symptoms of depression were also compared between patients with vitamin C deficiency and those with normal levels .
RESULTS	At baseline , 116 ( 36 % ) patients had a vitamin C concentration below 11 mol/L indicating biochemical depletion .
RESULTS	The figures at 6 weeks and 6 months were 28 ( 22 % ) and 44 ( 28 % ) patients , respectively .
RESULTS	Older age , male gender , smoking , increased dependency and tissue inflammation were associated with lower vitamin C concentrations .
RESULTS	Patients with vitamin C biochemical depletion had significantly increased symptoms of depression compared with those with higher concentrations at baseline ( p = 0.035 ) and at 6 weeks ( p = 0.028 ) .
CONCLUSIONS	A high proportion of older patients had sub-optimal vitamin C status and this was associated with increased symptoms of depression .

###24480867
BACKGROUND	There is a paucity of research on prehypertension and incident hypertension among postmenopausal Hispanic women .
BACKGROUND	The overall objective is to determine the multiple risk factors associated with the prevalence of hypertension status at baseline and incident hypertension at year 3 in postmenopausal Hispanic women .
METHODS	For the analyses in this paper , we included a total of 4,680 Hispanic women who participated in the Women 's Health Initiative ( WHI ) , a randomized clinical trial and observational study , at baseline ( 1994-1998 ) and at third-year follow-up and for whom blood pressure was measured at year 3 ( n = 3,848 ) .
METHODS	Multivariable logistic regression models were used to estimate odds ratios ( ORs ) and 95 % confidence intervals ( CIs ) of hypertension status , defined as systolic blood pressure 140 mm Hg and/or diastolic blood pressure 90 mm Hg , to assess the odds of incident hypertension at year 3 of follow-up in association with the factors included in the baseline models .
RESULTS	At year 3 of follow-up , 27.3 % of Hispanic women who were normotensive at baseline had progressed to prehypertension , and 9.0 % had become hypertensive .
RESULTS	Among the prehypertensive participants at baseline , 30.4 % had progressed to hypertension .
RESULTS	Compared with normotensive Hispanic women , hypertensive participants had a higher number of cardiovascular risk factors : body mass index 30 kg/m ( 2 ) ( OR = 3.76 ; 95 % CI = 3.01-4 .71 ) , a family history of diabetes , stroke , and/or myocardial infarction ( OR = 1.12 ; 95 % CI 1.03-1 .23 ) , treated hypercholesterolemia ( OR = 1.57 ; 95 % CI = 1.23-1 .99 ) , treated diabetes ( OR = 2.04 ; 95 % CI = 1.40-2 .97 ) , and a history of cardiovascular disease ( OR = 2.04 ; 95 % CI = 1.58-2 .64 ) .
CONCLUSIONS	Hispanic women seem to experience an increased risk of incident hypertension in later adulthood .
CONCLUSIONS	On a practical level , recommendations for preventive care and population-wide adoption of health behaviors , such as community-focused campaigns to engage in physical activity , may contribute to reductions in hypertension risk factors .
BACKGROUND	Trial Number NCT00000611 .

###25231565
BACKGROUND	Since the 1970s , MORA bioresonance therapy has globally been applied in the context of complementary medicine for various indications .
BACKGROUND	In this regard , practitioners also report successful application in smoking cessation .
BACKGROUND	The present study aims to verify these reports in a controlled study setting .
METHODS	In order to achieve the aforementioned objective , we subjected the bioresonance method to a prospective , placebo-controlled , double-blind , parallel-group study involving 190 smokers .
METHODS	In both study groups ( placebo n = 95 ; active bioresonance group ; n = 95 ) the course of treatment and study conditions were standardized .
RESULTS	1 week ( 77.2 % vs. 54.8 % ) , 2 weeks ( 62.4 % vs. 34.4 % ) , 1 month ( 51.1 % vs. 28.6 % ) , and 1 year ( 28.6 % vs. 16.1 % ) after treatment , the success rate in the verum group differed significantly from the results in the placebo group .
RESULTS	Also , the subjective health condition after treatment and subjective assessment of efficacy , polled after 1 week , were significantly more positive among participants in the active bioresonance therapy group than among those in the placebo group .
RESULTS	Adverse side effects were not observed .
CONCLUSIONS	According to the findings attained by this pilot study , bioresonance therapy is clinically effective in smoking cessation and does not show any adverse side effects .

###25343233
BACKGROUND	Graves ' orbitopathy ( GO ) is a potentially sight-threatening disease for which available medical therapy is not uniformly successful .
BACKGROUND	Multiple case series suggest that rituximab ( RTX ) may be effective therapy for GO patients .
OBJECTIVE	To determine the efficacy of RTX in GO .
METHODS	It is a prospective , randomized , double-masked , placebo-controlled trial .
METHODS	The study was conducted at a large academic private practice .
METHODS	Twenty five patients with active moderate to severe GO were enrolled , and 21 completed the study to the primary endpoint .
METHODS	Two RTX infusions ( 1000 mg each ) or two saline infusions were given 2 weeks apart .
METHODS	The primary endpoint was a reduction in clinical activity score ( CAS ) assessed as a continuum and separately as improvement by 2 points at 24 weeks .
METHODS	Secondary endpoints included success and failure rates , proportions showing clinically significant improvement in proptosis , lid fissure width , diplopia score , lagophthalmos and disease severity , and changes in those parameters , orbital fat / muscle volume and quality-of-life .
RESULTS	The treatment groups were similar in all parameters at baseline .
RESULTS	The last observation was carried forward if the patient discontinued prematurely .
RESULTS	No differences were found in the proportions of patients showing CAS improvement at 24 weeks ( 25 % placebo ; 31 % RTX , P = .75 ) or in CAS decrease from baseline to 24 or 52 weeks [ mean 1.5 points ( 1.8 SD ) placebo ; 1.2 ( 2 SD ) RTX at 24 weeks , P = .73 ] .
RESULTS	Similarly , there were no differences between groups in any of the secondary endpoints at either 24 or 52 weeks .
RESULTS	There were four adverse events ( AE ) in 3/12 placebo patients and 11 AE in 8/13 RTX-treated patients ; 5/6 moderate or severe AE occurred in the RTX group .
CONCLUSIONS	RTX offered no additional benefit over placebo to our patients with active and moderate to severe GO and carried with it non-negligible adverse effects .

###25407009
BACKGROUND	Borderline personality disorder ( BPD ) is a severe and highly prevalent mental disorder .
BACKGROUND	Schema therapy ( ST ) has been found effective in the treatment of BPD and is commonly delivered through an individual format .
BACKGROUND	A group format ( group schema therapy , GST ) has also been developed .
BACKGROUND	GST has been found to speed up and amplify the treatment effects found for individual ST. Delivery in a group format may lead to improved cost-effectiveness .
BACKGROUND	An important question is how GST compares to treatment as usual ( TAU ) and what format for delivery of schema therapy ( format A ; intensive group therapy only , or format B ; a combination of group and individual therapy ) produces the best outcomes .
METHODS	An international , multicentre randomized controlled trial ( RCT ) will be conducted with a minimum of fourteen participating centres .
METHODS	Each centre will recruit multiple cohorts of at least sixteen patients .
METHODS	GST formats as well as the orders in which they are delivered to successive cohorts will be balanced .
METHODS	Within countries that contribute an uneven number of sites , the orders of GST formats will be balanced within a difference of one .
METHODS	The RCT is designed to include a minimum of 448 patients with BPD .
METHODS	The primary clinical outcome measure will be BPD severity .
METHODS	Secondary clinical outcome measures will include measures of BPD and general psychiatric symptoms , schemas and schema modes , social functioning and quality of life .
METHODS	Furthermore , an economic evaluation that consists of cost-effectiveness and cost-utility analyses will be performed using a societal perspective .
METHODS	Lastly , additional investigations will be carried out that include an assessment of the integrity of GST , a qualitative study on patients ' and therapists ' experiences with GST , and studies on variables that might influence the effectiveness of GST .
CONCLUSIONS	This trial will compare GST to TAU for patients with BPD as well as two different formats for the delivery of GST .
CONCLUSIONS	By combining an evaluation of clinical effectiveness , an economic evaluation and additional investigations , it will contribute to an evidence-based understanding of which treatment should be offered to patients with BPD from clinical , economic , and stakeholders ' perspectives .
BACKGROUND	Netherlands Trial Register NTR2392 .
BACKGROUND	Registered 25 June 2010 .

###24648802
OBJECTIVE	Nonsteroidal anti-inflammatory drugs relieve osteoarthritis ( OA ) symptoms but cause adverse effects .
OBJECTIVE	D-002 , a mixture of beeswax alcohols , is effective against experimental OA .
OBJECTIVE	A pilot study found that D-002 ( 50 mg/day ) for 8 weeks improves OA symptoms .
OBJECTIVE	The aim of this study was to investigate the effects of D-002 ( 50 to 100 mg/day ) administered for 6 weeks on OA symptoms .
METHODS	Patients with OA symptoms were double-blindly randomized to D-002 ( 50 mg ) or placebo for 6 weeks .
METHODS	Symptoms were assessed by the Western Ontario and McMaster Individual Osteoarthritis Index ( WOMAC ) and the visual analog scale ( VAS ) scores .
METHODS	Patients without symptom improvement at week 3 were titrated to two daily tablets .
METHODS	The primary outcome was the total WOMAC score .
METHODS	WOMAC pain , joint stiffness and physical function scores , VAS score , and use of rescue medications were secondary outcomes .
RESULTS	All randomized patients ( n = 60 ) completed the study , and 23 experienced dose titration ( two in the D-002 and 21 in the placebo groups ) .
RESULTS	At study completion , D-002 reduced total WOMAC ( 65.4 % ) , pain ( 54.9 % ) , joint stiffness ( 76.8 % ) , and physical function ( 66.9 % ) WOMAC scores , and the VAS score ( 46.8 % ) versus placebo .
RESULTS	These reductions were significant beginning in the second week , and became enhanced during the trial .
RESULTS	The use of rescue medication by the D-002 ( 6/30 ) group was lower than that in the placebo ( 17/30 ) group .
RESULTS	The treatment was well tolerated .
RESULTS	Seven patients ( two in the D-002 and five in the placebo group ) reported adverse events .
CONCLUSIONS	These results indicate that D-002 ( 50 to 100 mg/day ) for 6 weeks ameliorated arthritic symptoms and was well tolerated .

###25654520
OBJECTIVE	To present the short-term follow-up findings of the Steps to Health study , a randomized trial to evaluate the effectiveness of two employee weight management programs offered within Duke University and the Health System .
METHODS	A total of 550 obese ( body mass index , 30 kg/m2 ) employees were randomized 1:1 between January 2011 and June 2012 to the education-based Weight Management ( WM ) or the WM + arm , which focused on behavior modification .
METHODS	Employees were contacted to complete a follow-up visit approximately 14 months after baseline .
RESULTS	There were no clinically , or statistically , meaningful differences between arms , but there were modest reductions in body mass index , and positive , meaningful changes in diet and physical activity for both arms .
CONCLUSIONS	The modest positive effects observed in this study may suggest that to achieve weight loss through the workplace more intensive interventions may be required .

###25646792
BACKGROUND	Treatment of neonates and infants with adrenal insufficiency is unsatisfactory because unlicensed hydrocortisone formulations are used .
OBJECTIVE	The objectives were to survey current hydrocortisone prescribing practice and develop a novel hydrocortisone formulation , Infacort .
METHODS	The use of hydrocortisone by European pediatric endocrinologists was surveyed .
METHODS	Based on this , an oral hydrocortisone granule formulation , Infacort , with taste masking was developed and evaluated in vitro and then in vivo in a phase I pharmacokinetic study .
RESULTS	The survey showed that pediatricians use a variety of unlicensed compounded adult medications at doses of between 0.5 and 5 mg .
RESULTS	Infacort was formulated with a taste-masking layer stable for at least 5 minutes in aqueous media and was produced in unit doses of 0.5 , 1 , 2 , and 5 mg .
RESULTS	Infacort 10 mg is the bioequivalent of a 10-mg hydrocortisone tablet ( mean area under the curve from zero to infinity [ AUC ( 0-inf ) ] ratio , 101 % ; 90 % confidence interval , 96-107 % ) .
RESULTS	Mean cortisol maximum concentration ( C ( max ) ) and AUC ( 0-inf ) values after administration of Infacort were linear with dose and dose proportional when adjusted for saturable plasma protein binding .
RESULTS	Subjects rated Infacort as `` not good or bad '' for smell ( 86 % ) , feel in the mouth ( 71 % ) , and taste ( 79 % ) .
RESULTS	No serious adverse events were reported .
CONCLUSIONS	This phase 1 study demonstrates that Infacort is safe , well tolerated , of neutral taste , bioequivalent to hydrocortisone licensed for adults , and shows dose proportionality with respect to cortisol exposure .
CONCLUSIONS	Infacort is expected to facilitate optimization of hydrocortisone dosing in neonates and children with adrenal insufficiency ; however , clinical studies will be required to demonstrate efficacy in this patient age group .

###25111196
OBJECTIVE	Late-onset infections commonly occur in extremely preterm infants and are associated with high rates of mortality and neurodevelopmental impairment .
OBJECTIVE	Hand hygiene alone does not always achieve the desired clean hands , as microorganisms are still present more than 50 % of the time .
OBJECTIVE	We hypothesize that glove use after hand hygiene may further decrease these infections .
OBJECTIVE	To determine if nonsterile glove use after hand hygiene before all patient and intravenous catheter contact , compared with hand hygiene alone , prevents late-onset infections in preterm infants .
METHODS	A prospective , single-center , clinical , randomized trial was conducted in infants admitted to the neonatal intensive care unit who weighed less than 1000 g and/or had a gestational age of less than 29 weeks and were less than 8 days old .
METHODS	There were 175 eligible infants , of which 120 were enrolled during a 30-month period from December 8 , 2008 , to June 20 , 2011 .
METHODS	Infants were randomly assigned to receive care with nonsterile gloves after hand hygiene ( group A ) or care after hand hygiene alone ( group B ) before all patient and intravenous line ( central and peripheral ) contact .
METHODS	Study intervention was continued while patients had central or peripheral venous access .
METHODS	One or more episodes of late-onset ( > 72 hours of age ) infection in the bloodstream , urinary tract , or cerebrospinal fluid or necrotizing enterocolitis .
RESULTS	The 2 groups were similar in baseline demographic characteristics .
RESULTS	Late-onset invasive infection or necrotizing enterocolitis occurred in 32 % of infants ( 19 of 60 ) in group A compared with 45 % of infants ( 27 of 60 ) in group B ( difference , -12 % ; 95 % CI , -28 % to 6 % ; P = .13 ) .
RESULTS	In group A compared with group B , there were 53 % fewer gram-positive bloodstream infections ( 15 % [ 9 of 60 ] vs 32 % [ 19 of 60 ] ; difference , -17 % ; 95 % CI , -31 % to -1 % ; P = .03 ) and 64 % fewer central line-associated bloodstream infections ( 3.4 vs 9.4 per 1000 central line days ; ratio , 0.36 ; 95 % CI , 0.16 to 0.81 ; P = .01 ) .
CONCLUSIONS	Glove use after hand hygiene prior to patient and line contact is associated with fewer gram-positive bloodstream infections and possible central line-associated bloodstream infections in preterm infants .
CONCLUSIONS	This readily implementable infection control measure may result in decreased infections in high-risk preterm infants .
BACKGROUND	clinicaltrials.gov Identifier : NCT01729000 .

###24285276
METHODS	Retrospective analysis of prospectively collected follow-up data for 2.9 years .
OBJECTIVE	To determine the natural history of subsequent morphometric fracture rates at adjacent levels ( one level above or below a previous known baseline fracture ) in a large patient database .
BACKGROUND	The long-term risk and risk factors for adjacent-level vertebral fractures in patients with osteoporosis are unknown .
METHODS	The fracture intervention trial is a large randomized , placebo-controlled trial of alendronate treatment for osteoporosis .
METHODS	Data from both bisphosphonate-treated and bisphosphonate-naive patients ( N = 1950 , vertebral fracture arm ) was analyzed to detect incident morphometric fracture rates .
RESULTS	During a mean follow-up of 2.9 years , 3.4 % of patients in the alendronate group and 7.4 % in the placebo group experienced adjacent-level vertebral fractures .
RESULTS	The annual rate of adjacent-level vertebral fractures was 1.2 % in the alendronate group , and 2.5 % in the placebo group ( overall , 1.8 % per year in both groups combined ) .
RESULTS	As expected , the thoracolumbar region ( defined as T11 , T12 , and L1 ) seemed to be the most prone to new adjacent-level fractures .
RESULTS	Among females with baseline prevalent fractures at the thoracolumbar junction , who subsequently experienced at least one new fracture anywhere along the spine ( N = 124 ) , 40.3 % had a new adjacent-level fracture in this region .
RESULTS	Older age at randomization , lower bone mineral density , inactivity , and placebo therapy were significantly associated with the development of adjacent-level fractures in univariate analysis ( P 0.05 ) .
RESULTS	Multivariate analysis indicated decreased odds of adjacent-level fractures with bisphosphonate therapy and higher bone mineral density , and increased odds with older age at randomization ( P 0.05 ) .
CONCLUSIONS	New vertebral fractures adjacent to prevalent fractures occurred relatively infrequently in this treatment trial of alendronate in females with osteoporosis , and were more common with older age at randomization , lower bone mineral density and placebo treatment .

###25205139
OBJECTIVE	Observational studies suggest that vitamin D may lower the risk of type 2 diabetes .
OBJECTIVE	However , data from long-term trials are lacking .
OBJECTIVE	The Vitamin D and Type 2 Diabetes ( D2d ) study is a randomized clinical trial designed to examine whether a causal relationship exists between vitamin D supplementation and the development of diabetes in people at high risk for type 2 diabetes .
METHODS	D2d was designed with support from a U34 planning grant from the National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK ) .
METHODS	The final protocol was approved by the D2d Research Group , the data and safety monitoring board , and NIDDK .
METHODS	Key eligibility criteria are age 30 years , BMI of 24 ( 22.5 for Asian Americans ) to 42 kg/m ( 2 ) , increased risk for diabetes ( defined as meeting two of three glycemic criteria for prediabetes established by the American Diabetes Association [ fasting glucose 100-125 mg/dL ( 5.5-6 .9 mmol/L ) , 2-h postload glucose after 75-g glucose load 140-199 mg/dL ( 7.7-11 .0 mmol/L ) , hemoglobin Ac 5.7-6 .4 % ( 39-46 mmol/mol ) ] ) , and no hyperparathyroidism , nephrolithiasis , or hypercalcemia .
METHODS	D2d participants are randomized to once-daily vitamin D ( cholecalciferol 4,000 IU ) or placebo and followed for an average of 3 years .
METHODS	The primary end point is time to incident diabetes as assessed by laboratory criteria during the study or by adjudication if diagnosed outside of D2d .
METHODS	Recruitment was initiated at the end of 2013 .
CONCLUSIONS	D2d will test whether vitamin D supplementation is safe and effective at lowering the risk of progression to diabetes in people at high risk for type 2 diabetes .

###24476530
BACKGROUND	Increasing numbers of patients are surviving critical illness , but survival may be associated with a constellation of physical and psychological sequelae that can cause ongoing disability and reduced health-related quality of life .
BACKGROUND	Limited evidence currently exists to guide the optimum structure , timing , and content of rehabilitation programmes .
BACKGROUND	There is a need to both develop and evaluate interventions to support and expedite recovery during the post-ICU discharge period .
BACKGROUND	This paper describes the construct development for a complex rehabilitation intervention intended to promote physical recovery following critical illness .
BACKGROUND	The intervention is currently being evaluated in a randomised trial ( ISRCTN09412438 ; funder Chief Scientists Office , Scotland ) .
METHODS	The intervention was developed using the Medical Research Council ( MRC ) framework for developing complex healthcare interventions .
METHODS	We ensured representation from a wide variety of stakeholders including content experts from multiple specialties , methodologists , and patient representation .
METHODS	The intervention construct was initially based on literature review , local observational and audit work , qualitative studies with ICU survivors , and brainstorming activities .
METHODS	Iterative refinement was aided by the publication of a National Institute for Health and Care Excellence guideline ( No. 83 ) , publicly available patient stories ( Healthtalkonline ) , a stakeholder event in collaboration with the James Lind Alliance , and local piloting .
METHODS	Modelling and further work involved a feasibility trial and development of a novel generic rehabilitation assistant ( GRA ) role .
METHODS	Several rounds of external peer review during successive funding applications also contributed to development .
RESULTS	The final construct for the complex intervention involved a dedicated GRA trained to pre-defined competencies across multiple rehabilitation domains ( physiotherapy , dietetics , occupational therapy , and speech/language therapy ) , with specific training in post-critical illness issues .
RESULTS	The intervention was from ICU discharge to 3 months post-discharge , including inpatient and post-hospital discharge elements .
RESULTS	Clear strategies to provide information to patients/families were included .
RESULTS	A detailed taxonomy was developed to define and describe the processes undertaken , and capture them during the trial .
RESULTS	The detailed process measure description , together with a range of patient , health service , and economic outcomes were successfully mapped on to the modified CONSORT recommendations for reporting non-pharmacologic trial interventions .
CONCLUSIONS	The MRC complex intervention framework was an effective guide to developing a novel post-ICU rehabilitation intervention .
CONCLUSIONS	Combining a clearly defined new healthcare role with a detailed taxonomy of process and activity enabled the intervention to be clearly described for the purpose of trial delivery and reporting .
CONCLUSIONS	These data will be useful when interpreting the results of the randomised trial , will increase internal and external trial validity , and help others implement the intervention if the intervention proves clinically and cost effective .

###24767584
BACKGROUND	Foot musculoskeletal deficits are seldom addressed by preventive medicine despite their high prevalence in patients with diabetic polyneuropathy .
OBJECTIVE	To investigate the effects of strengthening , stretching , and functional training on foot rollover process during gait .
METHODS	A two-arm parallel-group randomized controlled trial with a blinded assessor was designed .
METHODS	Fifty-five patients diagnosed with diabetic polyneuropathy , 45 to 65 years-old were recruited .
METHODS	Exercises for foot-ankle and gait training were administered twice a week , for 12 weeks , to 26 patients assigned to the intervention group , while 29 patients assigned to control group received recommended standard medical care : pharmacological treatment for diabetes and foot care instructions .
METHODS	Both groups were assessed after 12 weeks , and the intervention group at follow-up ( 24 weeks ) .
METHODS	Primary outcomes involved foot rollover changes during gait , including peak pressure ( PP ) .
METHODS	Secondary outcomes involved time-to-peak pressure ( TPP ) and pressure-time integral ( PTI ) in six foot-areas , mean center of pressure ( COP ) velocity , ankle kinematics and kinetics in the sagittal plane , intrinsic and extrinsic muscle function , and functional tests of foot and ankle .
RESULTS	Even though the intervention group primary outcome ( PP ) showed a not statistically significant change under the six foot areas , intention-to-treat comparisons yielded softening of heel strike ( delayed heel TPP , p = .03 ) , better eccentric control of forefoot contact ( decrease in ankle extensor moment , p < .01 ; increase in function of ankle dorsiflexion , p < .05 ) , earlier lateral forefoot contact with respect to medial forefoot ( TPP anticipation , p < .01 ) , and increased participation of hallux ( increased PP and PTI , p = .03 ) and toes ( increase in PTI , medium effect size ) .
RESULTS	A slower COP mean velocity ( p = .05 ) , and an increase in overall foot and ankle function ( p < .05 ) were also observed .
RESULTS	In most cases , the values returned to baseline after the follow-up ( p < .05 ) .
CONCLUSIONS	Intervention discreetly changed foot rollover towards a more physiological process , supported by improved plantar pressure distribution and better functional condition of the foot ankle complex .
CONCLUSIONS	Continuous monitoring of the foot status and patient education are necessary , and can contribute to preserving the integrity of foot muscles and joints impaired by polyneuropathy .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01207284 , registered in 20th September 2010 .

###24621807
BACKGROUND	In the Telmisartan Randomised AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease , all patients were at high cardiovascular risk , and a substantial proportion were hypertensive .
BACKGROUND	We performed a post-hoc analysis to explore the hypothesis that telmisartan has a differential action in hypertensive vs. nonhypertensive patients .
METHODS	The primary four-fold endpoint ( composite of cardiovascular death , myocardial infarction ( MI ) , stroke , or hospitalization for heart failure ) , the secondary three-fold endpoint ( cardiovascular death , MI , and stroke ) , the individual components , new onset of left ventricular hypertrophy ( LVH ) , and new onset of albuminuria were analyzed .
RESULTS	There was no evidence for a significantly differential treatment effect of telmisartan in hypertensive and nonhypertensive patients for any endpoints , although the occurrence of the secondary three-fold endpoint was significantly lower in the telmisartan group ( 13.0 % ) compared with placebo ( 15.0 % , P < 0.05 ) only in hypertensive patients .
RESULTS	Moreover , data from this post-hoc analysis suggest that MI may be less frequent in hypertensive patients treated with telmisartan ( 3.8 vs. 5.1 % ; P < 0.05 ) .
RESULTS	Telmisartan may also reduce new onset of LVH ( nonhypertensive patients P < 0.05 ; hypertensive patients P < 0.001 ) in both subgroups , and new onset of microalbuminuria and macroalbuminuria in hypertensive patients ( P < 0.001 and P < 0.01 , respectively ) .
RESULTS	The effect of telmisartan in hypertensive and nonhypertensive patients at high cardiovascular risk was not different .
RESULTS	This post-hoc analysis suggests that MI may be further reduced by telmisartan in hypertensive patients .
RESULTS	Further investigations are needed to study the hypotheses raised by this explanatory analysis .

###25164872
BACKGROUND	It is now recognized that preterm infants 28weeks gestation can be effectively supported from the outset with nasal continuous positive airway pressure .
BACKGROUND	However , this form of respiratory therapy may fail to adequately support those infants with significant surfactant deficiency , with the result that intubation and delayed surfactant therapy are then required .
BACKGROUND	Infants following this path are known to have a higher risk of adverse outcomes , including death , bronchopulmonary dysplasia and other morbidities .
BACKGROUND	In an effort to circumvent this problem , techniques of minimally-invasive surfactant therapy have been developed , in which exogenous surfactant is administered to a spontaneously breathing infant who can then remain on continuous positive airway pressure .
BACKGROUND	A method of surfactant delivery using a semi-rigid surfactant instillation catheter briefly passed into the trachea ( the `` Hobart method '' ) has been shown to be feasible and potentially effective , and now requires evaluation in a randomised controlled trial .
METHODS	This is a multicentre , randomised , masked , controlled trial in preterm infants 25-28 weeks gestation .
METHODS	Infants are eligible if managed on continuous positive airway pressure without prior intubation , and requiring FiO20 .30 at an age 6hours .
METHODS	Randomisation will be to receive exogenous surfactant ( 200mg/kg poractant alfa ) via the Hobart method , or sham treatment .
METHODS	Infants in both groups will thereafter remain on continuous positive airway pressure unless intubation criteria are reached ( FiO20 .45 , unremitting apnoea or persistent acidosis ) .
METHODS	Primary outcome is the composite of death or physiological bronchopulmonary dysplasia , with secondary outcomes including incidence of death ; major neonatal morbidities ; durations of all modes of respiratory support and hospitalisation ; safety of the Hobart method ; and outcome at 2years .
METHODS	A total of 606 infants will be enrolled .
METHODS	The trial will be conducted in > 30 centres worldwide , and is expected to be completed by end-2017 .
CONCLUSIONS	Minimally-invasive surfactant therapy has the potential to ease the burden of respiratory morbidity in preterm infants .
CONCLUSIONS	The trial will provide definitive evidence on the effectiveness of this approach in the care of preterm infants born at 25-28 weeks gestation .
BACKGROUND	Australia and New Zealand Clinical Trial Registry : ACTRN12611000916943 ; ClinicalTrials.gov : NCT02140580 .

###24587570
OBJECTIVE	Patients with excessive daytime sleepiness ( EDS ) are at high risk for driving accidents , and physicians are concerned by the effect of alerting drugs on driving skills of sleepy patients .
OBJECTIVE	No study has up to now investigated the effect of modafinil ( a reference drug to treat EDS in patients with hypersomnia ) on on-road driving performance of patients suffering from central hypersomnia .
OBJECTIVE	The objective is to evaluate in patients with central hypersomnia the effect of a wake-promoting drug on real driving performance and to assess the relationship between objective sleepiness and driving performance .
METHODS	Randomized , crossover , double-blind placebo-controlled trial conducted among 13 patients with narcolepsy and 14 patients with idiopathic hypersomnia .
METHODS	Patients were randomly assigned to receive modafinil ( 400 mg ) or placebo for 5 days prior to the driving test .
METHODS	Each condition was separated by at least 3 weeks of washout .
METHODS	Mean number of Inappropriate Line Crossings , Standard Deviation of Lateral Position of the vehicle and mean sleep latency in the Maintenance of Wakefulness Test were assessed .
RESULTS	Modafinil reduced the mean number of Inappropriate Line Crossings and Standard Deviation of Lateral Position of the vehicle compared to placebo ( F ( 1,25 ) = 4.88 , P < 0.05 and F ( 1,25 ) = 3.87 , P = 0.06 tendency ) .
RESULTS	Mean sleep latency at the Maintenance of Wakefulness Test significantly correlated with the mean number of Inappropriate Line Crossings ( r = -0.41 , P < 0.001 ) .
CONCLUSIONS	Modafinil improves driving performance in patients with narcolepsy and idiopathic hypersomnia .
CONCLUSIONS	The Maintenance of Wakefulness Test is a suitable clinical tool to assess fitness to drive in this population .

###24247661
BACKGROUND	Healthy gut microflora is essential for oral tolerance and immunity .
BACKGROUND	A promising approach to preventing allergic diseases in genetically at-risk infants is to introduce administration of probiotics early in life when their immune system is still relatively immature .
OBJECTIVE	In this follow-up study , we aim to determine if early-life supplementation with strains of probiotics has any long-term effect on allergic outcomes .
METHODS	We analyzed the charts and electronic databases of the PROMPT ( Probiotics in Milk for the Prevention of Atopy Trial ) study cohort .
METHODS	This cohort consisted of 253 infants at risk for allergy who were administered cow 's milk supplemented with or without probiotics from the first day of life to the age of 6 months .
METHODS	The cohort was then followed up until the children were 5 years old and clinical outcomes were assessed .
RESULTS	Of the 253 children recruited into the study , 220 ( 87 % ) completed the follow-up .
RESULTS	At the age of 5 years , there were no significant differences between the groups in the proportion of children who had developed any asthma , allergic rhinitis , eczema , food allergy and sensitization to inhalant allergens .
RESULTS	Similar growth rates were observed in both groups .
CONCLUSIONS	The supplementation of probiotics in early childhood did not play a role in the prevention of allergic diseases .
CONCLUSIONS	Clinical/Key Message : Early-life supplementation with probiotics did not change allergic outcomes at 5 years of age .

###24841974
OBJECTIVE	To investigate the efficacy of erlotinib versus docetaxel in previously treated patients with advanced non-small-cell lung cancer ( NSCLC ) in an epidermal growth factor receptor ( EGFR ) - unselected patient population .
METHODS	The primary end point was progression-free survival ( PFS ) .
METHODS	Secondary end points included overall survival ( OS ) , response rate , safety , and analyses on EGFR wild-type tumors .
METHODS	Patients with stage IIIB or IV NSCLC , previous treatment with one or two chemotherapy regimens , evaluable or measurable disease , and performance status of 0 to 2 were eligible .
RESULTS	From August 2009 to July 2012 , 150 and 151 patients were randomly assigned to erlotinib ( 150 mg daily ) and docetaxel ( 60 mg/m ( 2 ) every 3 weeks ) , respectively .
RESULTS	EGFR wild-type NSCLC was present in 109 and 90 patients in the erlotinib and docetaxel groups , respectively .
RESULTS	Median PFS for erlotinib versus docetaxel was 2.0 v 3.2 months ( hazard ratio [ HR ] , 1.22 ; 95 % CI , 0.97 to 1.55 ; P = .09 ) , and median OS was 14.8 v 12.2 months ( HR , 0.91 ; 95 % CI , 0.68 to 1.22 ; P = .53 ) , respectively .
RESULTS	In a subset analysis of EGFR wild-type tumors , PFS for erlotinib versus docetaxel was 1.3 v 2.9 months ( HR , 1.45 ; 95 % CI , 1.09 to 1.94 ; P = .01 ) , and OS was 9.0 v 10.1 months ( HR , 0.98 ; 95 % CI , 0.69 to 1.39 ; P = .91 ) , respectively .
CONCLUSIONS	Erlotinib failed to show an improvement in PFS or OS compared with docetaxel in an EGFR-unselected patient population .

###25937522
BACKGROUND	The OPUS study demonstrated that addition of cetuximab to 5-fluorouracil , folinic acid and oxaliplatin ( FOLFOX4 ) significantly improved objective response and progression-free survival ( PFS ) in the first-line treatment of patients with KRAS exon 2 wild-type metastatic colorectal cancer ( mCRC ) .
BACKGROUND	In patients with KRAS exon 2 mutations , a detrimental effect was seen upon addition of cetuximab to FOLFOX4 .
BACKGROUND	The current study reports outcomes in subgroups defined by extended RAS testing .
METHODS	Samples from OPUS study KRAS exon 2 wild-type tumours were reanalysed for other RAS mutations in four additional KRAS codons ( exons 3-4 ) and six NRAS codons ( exons 2-4 ) using BEAMing .
METHODS	A cutoff of 5 % mutant/wild-type sequences was selected to define RAS status ; we also report an analysis using a cutoff based on the technical lower limit for mutation identification ( 0.1 % ) .
RESULTS	Other RAS mutations were detected in 31/118 ( 26 % ) evaluable patients .
RESULTS	In the extended analysis of RAS wild-type tumours ( n = 87 ) , objective response was significantly improved by addition of cetuximab to FOLFOX4 ( 58 % versus 29 % ; odds ratio 3.33 [ 95 % confidence interval 1.36-8 .17 ] ; P = 0.0084 ) ; although limited by population size , there also appeared to be trends favouring the cetuximab arm in terms of PFS and overall survival in the RAS wild-type group compared with the RAS evaluable group .
RESULTS	There was no evidence that patients with other RAS mutations benefited from cetuximab , but small numbers precluded precise estimations of treatment effects .
RESULTS	In the combined population of patients with any RAS mutation ( KRAS exon 2 or other RAS ) , a clear detrimental effect was associated with addition of cetuximab to FOLFOX4 .
CONCLUSIONS	Patients with RAS-mutant mCRC , as defined by mutations in KRAS and NRAS exons 2-4 , derive no benefit and may be harmed by the addition of cetuximab to FOLFOX4 .
CONCLUSIONS	Restricting cetuximab administration to patients with RAS wild-type tumours will further tailor therapy to maximise benefit .

###25350474
OBJECTIVE	Refractory chronic low back pain ( CLBP ) often leads to treatment with long-term opioids .
OBJECTIVE	Our goal was to describe the pharmaco-toxicological profile of opioid-treated CLBP patients and identify potential areas for care optimization .
METHODS	Cross-sectional analysis .
METHODS	Outpatient primary care .
METHODS	CLBP patients prescribed 30 mg/d of morphine-equivalent dose ( MED ) for 3 months .
METHODS	Self-reported clinical , medication ( verified ) and substance use , and urine drug testing ( UDT ) data were collected .
RESULTS	Participants ( N = 35 ) were 51.8 9.7 years old , 80 percent female with CLBP for 14.2 10.1 years , treated with opioids for 7.9 5.7 years , with severe disability ( Oswestry Disability Index score : 66.7 11.4 ) , and average pain score of 5.6 1.5 ( 0-10 rating scale ) .
RESULTS	Participants reported using tobacco ( N = 14 ) , alcohol ( N = 9 ) and illicit drugs or unprescribed medications ( N = 10 ) .
RESULTS	On average , participants took 13.4 6.8 daily medications , including 4.7 1.8 pain-modulating and 4.7 2.0 sedating medications .
RESULTS	Among prescribed opioids , 57.1 percent were long-acting and 91.4 percent were short-acting , with a total of 144.5 127.8 mg/d of MED .
RESULTS	Sixteen participants were prescribed benzodiazepines and/or zolpidem / zaleplon .
RESULTS	Fifteen participants had UDT positive for illicit drugs or unprescribed medications ; in addition , eight tested positive for alcohol and 19 for cotinine .
RESULTS	Compared to those with negative UDTs , those with positive UDTs ( N = 15 ) received lower daily `` total '' and `` extended release '' opioid doses , and were more likely to test positive for cotinine ( p < 0.05 ) .
CONCLUSIONS	Study findings corroborate existing evidence for high medication burden and high likelihood of substance misuse among opioid-treated CLBP patients .
CONCLUSIONS	Further research is needed to help understand causality and ways to optimize care and clinical outcomes .

###25827507
OBJECTIVE	Few prospective studies examine the impact of ethnicity or race on outcomes with lithium for bipolar disorder .
OBJECTIVE	This exploratory study examines differences in lithium response and treatment outcomes in Hispanics , African Americans , and non-Hispanic whites with bipolar disorder in the Lithium Treatment Moderate Dose Use Study ( LiTMUS ) .
METHODS	LiTMUS was a six-site randomized controlled trial of low-dose lithium added to optimized treatment ( OPT ; personalized , evidence-based pharmacotherapy ) vs. OPT alone in outpatients with bipolar disorder .
METHODS	Of 283 participants , 47 African Americans , 39 Hispanics , and 175 non-Hispanic whites were examined .
METHODS	We predicted minority groups would have more negative medication attitudes and higher attrition rates , but better clinical outcomes .
RESULTS	African Americans in the lithium group improved more on depression and life functioning compared to whites over the 6 month study .
RESULTS	African Americans in the OPT only group had marginal improvement on depression symptoms .
RESULTS	For Hispanics , satisfaction with life did not significantly improve in the OPT only group , in contrast to whites and African Americans who improved over time on all measures .
RESULTS	Attitudes toward medications did not differ across ethnic/racial groups .
CONCLUSIONS	African Americans show some greater improvements with lithium than non-Hispanic whites , and Hispanics showed more consistent improvements in the lithium group .
CONCLUSIONS	The impact of low-dose lithium should be studied in a larger sample as there may be particular benefit for African Americans and Hispanics .
CONCLUSIONS	Given that the control group ( regardless of ethnicity/race ) had significant improvements , optimized treatment may be beneficial for any ethnic group .

###24886352
BACKGROUND	Approximately 1 in 5 pregnant women in the United Kingdom are obese .
BACKGROUND	In addition to being associated generally with poor health , obesity is known to be a contributing factor to pregnancy and birth complications and the retention of gestational weight can lead to long term obesity.This paper describes the protocol for a cluster randomised trial to evaluate whether a weight management intervention for obese pregnant women is effective in reducing women 's Body Mass Index at 12 months following birth .
METHODS	The study is a cluster randomised controlled trial involving 20 maternity units across England and Wales .
METHODS	The units will be randomised , 10 to the intervention group and 10 to the control group .
METHODS	570 pregnant women aged 18 years or over , with a Body Mass Index of + / = 30 ( kg/m2 ) and between 12 and 20 weeks gestation will be recruited .
METHODS	Women allocated to the control group will receive usual care and two leaflets giving advice on diet and physical activity .
METHODS	In addition to their usual care and the leaflets , women allocated to the intervention group will be offered to attend a weekly 1.5 hour weight management group , which combines expertise from Slimming World with clinical advice and supervision from National Health Service midwives , until 6 weeks postpartum.Participants will be followed up at 36 weeks gestation and at 6 weeks , 6 months and 12 months postpartum .
METHODS	Body Mass Index at 12 months postpartum is the primary outcome .
METHODS	Secondary outcomes include pregnancy weight gain , quality of life , mental health , waist-hip ratio , child weight centile , admission to neonatal unit , diet , physical activity levels , pregnancy and birth complications , social support , self-regulation and self-efficacy .
METHODS	A cost effectiveness analysis and process evaluation will also be conducted .
CONCLUSIONS	This study will evaluate the effectiveness of a theory-based intervention developed for obese pregnant women .
CONCLUSIONS	If successful the intervention will equip women with the necessary knowledge and skills to enable them to make healthier choices for themselves and their unborn child .
BACKGROUND	Current Controlled Trials : ISRCTN25260464 Date of registration : 16th April 2010 .

###24611967
OBJECTIVE	Effective medicines have not been introduced for insulin resistance-related fatty liver .
OBJECTIVE	The efficacy and safety of treatment between a combination of metformin and carnitine-orotate complex and metformin alone in a 12-week , double-blind , randomized , placebo-controlled study on drug-nave patients with impaired glucose metabolism and fatty liver were compared .
METHODS	Fifty-two patients with fasting glucose 100-240mg / dL or glycosylated hemoglobin ( HbA1c ) 6.0 % and alanine aminotransferase ( ALT ) 40-250 IU/L were randomized to receive metformin ( 250mg t.i.d. ) , or metformin ( 250mg t.i.d. ) and carnitine-orotate complex ( 300mg t.i.d. ) for 12 weeks ( n = 26 per group ) .
METHODS	The primary end-point was a change from baseline ALT level .
METHODS	Secondary end-points were changes in fasting glucose , HbA1c , aspartate aminotransferase levels , mitochondrial DNA ( mtDNA ) copy number in the peripheral blood , and urinary output of 8-hydroxy-2 ' - deoxyguanosine , a marker of oxidative stress .
RESULTS	The combined treatment reduced ALT level significantly more than metformin alone ( -51.533.2 IU/Lvs -16.731.3 IU/L , P = 0.001 ) .
RESULTS	The HbA1c levels also decreased significantly in both groups but there was no significant difference between them ( -0.9 % 1.0 % vs -0.7 % 0.9 % ) .
RESULTS	Treatment with the complex decreased the urinary 8-hydroxy-2 ' - deoxyguanosine level and increased mtDNA copy number significantly compared with metformin alone ( both P < 0.05 ) .
RESULTS	No severe adverse events were observed .
CONCLUSIONS	A 12-week treatment with metformin and carnitine-orotate complex significantly improved liver function enzyme levels .
CONCLUSIONS	This was associated with changes in oxidative stress and mtDNA copy number compared with metformin alone in patients with impaired glucose metabolism and fatty liver ( clinical trial number : KCT0000193 ) .

###24342522
BACKGROUND	There are limited therapeutic options to slow the progression of autosomal dominant polycystic kidney disease ( ADPKD ) .
BACKGROUND	Recent clinical studies indicate that somatostatin analogues are promising for treating polycystic liver disease and potentially also for the kidney phenotype .
BACKGROUND	We report on the design of the DIPAK 1 ( Developing Interventions to Halt Progression of ADPKD 1 ) Study , which will examine the efficacy of the somatostatin analogue lanreotide on preservation of kidney function in ADPKD .
METHODS	The DIPAK 1 Study is an investigator-driven , randomized , multicenter , controlled , clinical trial .
METHODS	We plan to enroll 300 individuals with ADPKD and estimated glomerular filtration rate ( eGFR ) of 30-60 mL/min/1 .73 m ( 2 ) who are aged 18-60 years .
METHODS	Patients will be randomly assigned ( 1:1 ) to standard care or lanreotide , 120 mg , subcutaneously every 28 days for 120 weeks , in addition to standard care .
RESULTS	Main study outcome is the slope through serial eGFR measurements starting at week 12 until end of treatment for lanreotide versus standard care .
RESULTS	Secondary outcome parameters include change in eGFR from pretreatment versus 12 weeks after treatment cessation , change in kidney volume , change in liver volume , and change in quality of life .
METHODS	Blood and urine will be collected and questionnaires will be filled in following a fixed scheme .
METHODS	Magnetic resonance imaging will be performed for assessment of kidney and liver volume .
RESULTS	Assuming an average change in eGFR of 5.2 4.3 ( SD ) mL/min/1 .73 m ( 2 ) per year in untreated patients , 150 patients are needed in each group to detect a 30 % reduction in the rate of kidney function loss between treatment groups with 80 % power , 2-sided = 0.05 , and 20 % protocol violators and/or dropouts .
CONCLUSIONS	The design is an open randomized controlled trial and measurement of our primary end point does not begin at randomization .
CONCLUSIONS	The DIPAK 1 Study will show whether subcutaneous administration of lanreotide every 4 weeks attenuates disease progression in patients with ADPKD .

###26035669
BACKGROUND	Exercise is important for fitness and recovery of older adults after hospitalization for treatment of cardiovascular disease .
BACKGROUND	Home-based , nurse-led exercise programs may be beneficial .
OBJECTIVE	The aim of this study was to test the effects of a low-intensity , home-based exercise protocol led by an advanced practice nurse on health-related quality of life ( HRQOL ) , physical fitness , and left ventricular ejection fraction ( LVEF ) in older adults after hospital discharge with a cardiovascular disease diagnosis .
METHODS	The study was randomized and single blinded .
METHODS	Seventy-seven older adults ( 75 years old , mean = 80.68 years old ) were included ; 32 subjects in the intervention and 29 in the control group completed the study .
METHODS	The low-intensity , home-based exercise protocol is composed of 14-type joint exercises and walking for 12 weeks .
METHODS	The main outcome measures were assessments on the Medical Outcomes Study Short-Form-36 , the Senior Fitness Test , and LVEF at baseline and 12 weeks after hospital discharge .
RESULTS	After 12 weeks , the intervention group showed significant improvements in HRQOL ( physical functioning , role-physical , bodily pain , and vitality ; p < .05 ) as well as on the Senior Fitness Test ( chair stands , arm curls , Timed Up and Go , and 6-minute walk distance ; p < .05 ) ; there was no significant improvement in LVEF ( p = .56 ) .
CONCLUSIONS	The low-intensity , home-based exercise led by an advanced practice nurse was effective in improving HRQOL and physical fitness .
CONCLUSIONS	Adherence was high , and there were no adverse events related to exercise .

###25884648
BACKGROUND	Tobacco use is responsible for the death of about 1 in 10 individuals worldwide .
BACKGROUND	Mindfulness training has shown preliminary efficacy as a behavioral treatment for smoking cessation .
BACKGROUND	Recent advances in mobile health suggest advantages to smartphone-based smoking cessation treatment including smartphone-based mindfulness training .
BACKGROUND	This study evaluates the efficacy of a smartphone app-based mindfulness training program for improving smoking cessation rates at 6-months follow-up .
METHODS	A two-group parallel-randomized clinical trial with allocation concealment will be conducted .
METHODS	Group assignment will be concealed from study researchers through to follow-up .
METHODS	The study will be conducted by smartphone and online .
METHODS	Daily smokers who are interested in quitting smoking and own a smartphone ( n = 140 ) will be recruited through study advertisements posted online .
METHODS	After completion of a baseline survey , participants will be allocated randomly to the control or intervention group .
METHODS	Participants in both groups will receive a 22-day smartphone-based treatment program for smoking .
METHODS	Participants in the intervention group will receive mobile mindfulness training plus experience sampling .
METHODS	Participants in the control group will receive experience sampling-only .
METHODS	The primary outcome measure will be one-week point prevalence abstinence from smoking ( at 6-months follow-up ) assessed using carbon monoxide breath monitoring , which will be validated through smartphone-based video chat .
CONCLUSIONS	This is the first intervention study to evaluate smartphone-based delivery of mindfulness training for smoking cessation .
CONCLUSIONS	Such an intervention may provide treatment in-hand , in real-world contexts , to help individuals quit smoking .
BACKGROUND	Clinicaltrials.gov NCT02134509 .
BACKGROUND	Registered 7 May 2014 .

###25002083
BACKGROUND	Triptans are a family of selective serotonin ( 5-HT1B / 1D ) receptor agonists that are widely used to treat acute migraine attacks .
BACKGROUND	Their efficacy is limited by side effects and the gastrointestinal manifestations of migraine .
OBJECTIVE	To compare the efficacy of a single intravenous administration of propacetamol , a prodrug of paracetamol ( acetaminophen ) with a single dose of oral rizatriptan in treating acute migraine attacks .
METHODS	Patients were selected from those who presented to the emergency room with a diagnosed migraine attack and who had not previously taken any analgesics .
METHODS	They were randomized into 2 groups : treatment with a single 1g IV dose of propacetamol or with a single oral dose of 5mg rizatriptan .
METHODS	Their Visual Analogue Scale ( VAS ) pain scores were assessed before and at 30 , 60 , and 120min after treatment .
RESULTS	The patients who received the propacetamol had significantly improved VAS scores at 60min compared to the rizatriptan group .
RESULTS	There were no significant differences in VAS scores at 30 or 120min post-treatment .
CONCLUSIONS	Propacetamol is either equivalent or superior in efficacy to rizatriptan for treating acute migraine attacks , while having the advantage of parenteral administration in patients whose migraines are accompanied by nausea and vomiting .

###25956661
BACKGROUND	Onychomycosis , a fungal nail infection , can impact quality of life .
OBJECTIVE	We sought to evaluate the efficacy and safety of tavaborole topical solution , 5 % for treatment of toenail onychomycosis .
METHODS	In 2 phase-III trials , adults with distal subungual onychomycosis affecting 20 % to 60 % of a target great toenail were randomized 2:1 to tavaborole or vehicle once daily for 48 weeks .
METHODS	The primary end point was complete cure of the target great toenail ( completely clear nail with negative mycology ) at week 52 .
METHODS	Secondary end points included completely or almost clear nail , negative mycology , completely or almost clear nail plus negative mycology , and safety .
RESULTS	Rates of negative mycology ( 31.1 % -35.9 % vs 7.2 % -12.2 % ) and complete cure ( 6.5 % and 9.1 % vs 0.5 % and 1.5 % ) significantly favored tavaborole versus vehicle ( P .001 ) .
RESULTS	Completely or almost clear nail rates also significantly favored tavaborole versus vehicle ( 26.1 % -27.5 % vs 9.3 % -14.6 % ; P < .001 ) .
RESULTS	Rates of completely or almost clear nail plus negative mycology ( 15.3 % -17.9 % vs 1.5 % -3.9 % ) were significantly greater for tavaborole versus vehicle ( P < .001 ) .
RESULTS	Application-site reactions with tavaborole included exfoliation ( 2.7 % ) , erythema ( 1.6 % ) , and dermatitis ( 1.3 % ) .
CONCLUSIONS	Duration of follow-up is a limitation .
CONCLUSIONS	Tavaborole demonstrates a favorable benefit-risk profile in treatment of toenail onychomycosis .

###25431023
BACKGROUND	Atrial fibrillation ( AF ) is frequently comorbid in patients receiving cardiac resynchronization therapy ( CRT ) , and suppression is typically difficult .
BACKGROUND	Herein , we sought to understand the benefit of atrial rhythm control in the setting of ventricular rate and regularity control induced by atrioventricular node ( AVN ) ablation .
METHODS	Fifty-two patients with heart failure , persistent AF , left ventricular ( LV ) ejection fraction < 35 % , and left bundle branch block underwent cardiac resynchronization therapy ( CRT ) + AVN ablation , and were randomized to one of the following groups : ( 1 ) Atrial Rhythm Control ( ARC ) ; ( 2 ) AF .
METHODS	Patients were subsequently followed for up to 1 year .
RESULTS	Similar numbers of patients in each group were lost to follow-up or have withdrawn ( ARC two ; AF three ) .
RESULTS	Rhythm control in four patients in the ARC group was inadequate .
RESULTS	Among the remaining patients , the incidence of death ( ARC = 1 , AF = 2 ) or left ventricular assist device + / - transplantation ( ARC = 2 , AF = 1 ) were similar .
RESULTS	Among the remaining patients ( ARC 16 , AF 19 ) , at 1 year , there were no significant differences in CRT response rate , Minnesota Living with Heart Failure survey score , 6-minute hall walk distance , ventricular tachyarrhythmia occurrence , or LV dimensions .
RESULTS	A significantly higher hospital encounter rate among ARC patients was attributable to efforts to maintain uniform atrial rhythm .
CONCLUSIONS	In this pilot study , no incremental benefit for ARC was apparent .
CONCLUSIONS	A larger study will be necessary to adequately examine these issues .

###24795252
BACKGROUND	Reduction of dietary sodium intake or diuretic treatment increases renin-angiotensin-aldosterone system ( RAAS ) blockade efficacy in non-diabetic nephropathy .
BACKGROUND	We aimed to investigate the effect of sodium restriction and the diuretic hydrochlorothiazide , separately and in combination , added to RAAS blockade on residual albuminuria in patients with type 2 diabetic nephropathy .
METHODS	In this multicentre , double-blind , placebo-controlled , crossover randomised trial , we included patients with type 2 diabetic nephropathy .
METHODS	Main entry criteria were microalbuminaria or macroalbuminuria , and creatinine clearance of 30 mL/min or higher with less than 6 mL/min decline in the previous year .
METHODS	We tested the separate and combined effects of sodium restriction ( dietary counselling in the outpatient setting ) and hydrochlorothiazide ( 50 mg daily ) , added to standardised maximal angiotensin-converting enzyme ( ACE ) inhibition ( lisinopril 40 mg daily ) , on albuminuria ( primary endpoint ) .
METHODS	Patients were given hydrochlorothiazide ( 50 mg per day ) or placebo during four treatment periods of 6 weeks .
METHODS	Both treatments were combined with regular sodium diet or sodium restriction ( target sodium intake 50 mmol Na ( + ) per day ) .
METHODS	The 6-week treatment periods were done consecutively in a random order .
METHODS	Patients were randomised in blocks of two patients .
METHODS	The trial was analysed by intention to treat .
METHODS	The trial is registered with TrialRegister.nl , number 2366 .
RESULTS	Of 89 eligible patients , 45 were included in the study .
RESULTS	Both sodium restriction and hydrochlorothiazide significantly reduced albuminuria , irrespective of treatment sequence .
RESULTS	Residual geometric mean albuminuria with baseline treatment was 711 mg per day ( 95 % CI 485-1043 ) ; it was significantly reduced by sodium restriction ( 393 mg per day [ 258-599 ] , p = 00002 ) , by hydrochlorothiazide ( 434 mg per day [ 306-618 ] , p = 00003 ) , and to the greatest extent by their combination ( 306 mg per day [ 203-461 ] , p < 00001 ) .
RESULTS	Orthostatic complaints were present in two patients ( 4 % ) during baseline treatment , five ( 11 % ) during addition of sodium restriction , five ( 11 % ) during hydrochlorothiazide treatment , and 12 ( 27 % ) during combination treatment .
RESULTS	No serious adverse events occurred .
CONCLUSIONS	We conclude that sodium restriction is an effective non-pharmacological intervention to increase RAAS blockade efficacy in type 2 diabetic nephropathy .
BACKGROUND	None .

###25773919
BACKGROUND	Many patients have symptoms suggestive of coronary artery disease ( CAD ) and are often evaluated with the use of diagnostic testing , although there are limited data from randomized trials to guide care .
METHODS	We randomly assigned 10,003 symptomatic patients to a strategy of initial anatomical testing with the use of coronary computed tomographic angiography ( CTA ) or to functional testing ( exercise electrocardiography , nuclear stress testing , or stress echocardiography ) .
METHODS	The composite primary end point was death , myocardial infarction , hospitalization for unstable angina , or major procedural complication .
METHODS	Secondary end points included invasive cardiac catheterization that did not show obstructive CAD and radiation exposure .
RESULTS	The mean age of the patients was 60.88.3 years , 52.7 % were women , and 87.7 % had chest pain or dyspnea on exertion .
RESULTS	The mean pretest likelihood of obstructive CAD was 53.321.4 % .
RESULTS	Over a median follow-up period of 25 months , a primary end-point event occurred in 164 of 4996 patients in the CTA group ( 3.3 % ) and in 151 of 5007 ( 3.0 % ) in the functional-testing group ( adjusted hazard ratio , 1.04 ; 95 % confidence interval , 0.83 to 1.29 ; P = 0.75 ) .
RESULTS	CTA was associated with fewer catheterizations showing no obstructive CAD than was functional testing ( 3.4 % vs. 4.3 % , P = 0.02 ) , although more patients in the CTA group underwent catheterization within 90 days after randomization ( 12.2 % vs. 8.1 % ) .
RESULTS	The median cumulative radiation exposure per patient was lower in the CTA group than in the functional-testing group ( 10.0 mSv vs. 11.3 mSv ) , but 32.6 % of the patients in the functional-testing group had no exposure , so the overall exposure was higher in the CTA group ( mean , 12.0 mSv vs. 10.1 mSv ; P < 0.001 ) .
CONCLUSIONS	In symptomatic patients with suspected CAD who required noninvasive testing , a strategy of initial CTA , as compared with functional testing , did not improve clinical outcomes over a median follow-up of 2 years .
CONCLUSIONS	( Funded by the National Heart , Lung , and Blood Institute ; PROMISE ClinicalTrials.gov number , NCT01174550 . )

###24927118
BACKGROUND	Electroencephalographic-based monitoring systems such as the bispectral index ( BIS ) may reduce anaesthetic overdose rates .
OBJECTIVE	We hypothesised that goal-directed sevoflurane administration ( guided by BIS monitoring ) could reduce the sevoflurane plasma concentration ( SPC ) and intraoperative vasopressor doses during on-pump cardiac surgery .
METHODS	A prospective , controlled , sequential two-arm clinical study .
METHODS	German university medical centre with more than 2500 cardiac surgery interventions per year .
METHODS	Sixty elective on-pump cardiac surgery patients .
METHODS	In group Sevo1 .8 % ( n = 29 ) , the sedation depth was maintained with a sustained inspired concentration of sevoflurane 1.8 % before and during cardiopulmonary bypass ( CPB ) .
METHODS	In group SevoBIS ( n = 31 ) , the inspired sevoflurane concentration was titrated to maintain a BIS target between 40 and 60 .
METHODS	SPC during CPB and the intraoperative administration of noradrenaline .
METHODS	Additional analyses were performed on intraoperative awareness , postoperative blood lactate concentration , duration of mechanical ventilation , intensive care unit length of stay and kidney injury .
RESULTS	Mean inspired sevoflurane concentration was 0.8 % in group SevoBIS , representing a 57.1 % reduction ( P < 0.001 ) compared with group Sevo1 .8 % .
RESULTS	The mean SPC was 42.3 gml ( -1 ) [ 95 % confidence interval ( CI ) 40.0 to 44.6 ] in group Sevo1 .8 % and 21.0 gml ( -1 ) ( 95 % CI 18.8 to 23.3 ) in group SevoBIS , representing a 50.2 % reduction ( P < 0.001 ) .
RESULTS	During CPB , the mean cumulative dose of noradrenaline administered was 13.48 gkg ( -1 ) ( 95 % CI 10.52 to 17.19 ) in group Sevo1 .8 % and 4.06 gkg ( -1 ) ( 95 % CI 2.67 to 5.97 ) in group SevoBIS ( P < 0.001 ) .
RESULTS	Pearson 's correlation coefficient ( between the cumulative applied dosage of sevoflurane calculated from the area under the curve of the SPC over time and the administered cumulative noradrenaline dose ) was 0.607 ( P < 0.001 ) .
RESULTS	No intraoperative awareness signs were detected .
CONCLUSIONS	BIS-guided titration of sevoflurane reduces the SPC and decreases noradrenaline administration compared with routine care during on-pump cardiac surgery .

###24497963
BACKGROUND	Statins have anti-inflammatory and immunomodulatory properties in addition to lipid-lowering effects .
OBJECTIVE	To report the 12-month extension of a phase II trial evaluating the efficacy , safety and tolerability of atorvastatin 40 mg/d added to interferon beta-1b ( IFNB-1b ) in relapsing-remitting multiple sclerosis ( RRMS ) .
METHODS	In the randomized , multicenter , parallel-group , rater-blinded core study , 77 RRMS patients started IFNB-1b .
METHODS	At month three they were randomized 11 to receive atorvastatin 40 mg/d or not in addition to IFNB-1b until month 15 .
METHODS	In the subsequent extension study , patients continued with unchanged medication for another 12 months .
METHODS	Data at study end were compared to data at month three of the core study .
RESULTS	27 of 72 patients that finished the core study entered the extension study .
RESULTS	45 patients were lost mainly due to a safety analysis during the core study including a recruitment stop for the extension study .
RESULTS	The primary end point , the proportion of patients with new lesions on T2-weighted images was equal in both groups ( odds ratio 1.926 ; 95 % CI 0.265-14 .0007 ; p = 0.51 ) .
RESULTS	All secondary endpoints including number of new lesions and total lesion volume on T2-weighted images , total number of Gd-enhancing lesions on T1-weighted images , volume of grey and white matter , EDSS , MSFC , relapse rate , number of relapse-free patients and neutralizing antibodies did not show significant differences either .
RESULTS	The combination therapy was well tolerated .
CONCLUSIONS	Atorvastatin 40 mg/day in addition to IFNB-1b did not have any beneficial effects on RRMS compared to IFNB-1b monotherapy over a period of 24 months .
BACKGROUND	ClinicalTrials.gov NCT01111656 .

###24366103
OBJECTIVE	Convergent biological , epidemiological , and clinical data identified urate elevation as a candidate strategy for slowing disability progression in Parkinson disease ( PD ) .
OBJECTIVE	To determine the safety , tolerability , and urate-elevating capability of the urate precursor inosine in early PD and to assess its suitability and potential design features for a disease-modification trial .
METHODS	The Safety of Urate Elevation in PD ( SURE-PD ) study , a randomized , double-blind , placebo-controlled , dose-ranging trial of inosine , enrolled participants from 2009 to 2011 and followed them for up to 25 months at outpatient visits to 17 credentialed clinical study sites of the Parkinson Study Group across the United States .
METHODS	Seventy-five consenting adults ( mean age , 62 years ; 55 % women ) with early PD not yet requiring symptomatic treatment and a serum urate concentration less than 6 mg/dL ( the approximate population median ) were enrolled .
METHODS	Participants were randomized to 1 of 3 treatment arms : placebo or inosine titrated to produce mild ( 6.1-7 .0 mg/dL ) or moderate ( 7.1-8 .0 mg/dL ) serum urate elevation using 500-mg capsules taken orally up to 2 capsules 3 times per day .
METHODS	They were followed for up to 24 months ( median , 18 months ) while receiving the study drug plus 1 washout month .
METHODS	The prespecified primary outcomes were absence of unacceptable serious adverse events ( safety ) , continued treatment without adverse event requiring dose reduction ( tolerability ) , and elevation of urate assessed serially in serum and once ( at 3 months ) in cerebrospinal fluid .
METHODS	RESULTS Serious adverse events ( 17 ) , including infrequent cardiovascular events , occurred at the same or lower rates in the inosine groups relative to placebo .
METHODS	No participant developed gout and 3 receiving inosine developed symptomatic urolithiasis .
METHODS	Treatment was tolerated by 95 % of participants at 6 months , and no participant withdrew because of an adverse event .
METHODS	Serum urate rose by 2.3 and 3.0 mg/dL in the 2 inosine groups ( P < .001 for each ) vs placebo , and cerebrospinal fluid urate level was greater in both inosine groups ( P = .006 and < .001 , respectively ) .
METHODS	Secondary analyses demonstrated nonfutility of inosine treatment for slowing disability .
CONCLUSIONS	Inosine was generally safe , tolerable , and effective in raising serum and cerebrospinal fluid urate levels in early PD .
CONCLUSIONS	The findings support advancing to more definitive development of inosine as a potential disease-modifying therapy for PD .
BACKGROUND	clinicaltrials.gov Identifier : NCT00833690 .

###24928269
OBJECTIVE	Endoscopic injection of a bulking agent is becoming a first-line treatment for low grade vesicoureteral reflux .
OBJECTIVE	We prospectively compared the efficacy of 2 such products commercially available in Canada .
METHODS	A total of 275 patients with documented grade I to V vesicoureteral reflux were prospectively enrolled in a comparative study between April 2005 and February 2011 to be randomly treated endoscopically with either polydimethylsiloxane ( Macroplastique ) or dextranomer/hyaluronic acid copolymer ( Deflux ) .
METHODS	Of the ureters 202 were treated with polydimethylsiloxane and 197 with dextranomer/hyaluronic acid copolymer .
METHODS	Patients were followed with voiding cystourethrography at 3 months and renal ultrasonography at 3 months and at 1 year .
METHODS	Median followup was 4.3 years .
METHODS	The primary outcome was surgical success ( resolution vs nonresolution ) , and secondary outcomes included occurrence of adverse events .
RESULTS	Vesicoureteral reflux was fully corrected in 182 of 202 ureters ( 90 % ) treated with polydimethylsiloxane , compared to 159 of 197 ( 81 % ) treated with dextranomer/hyaluronic acid copolymer ( p < 0.05 ) .
RESULTS	Obstruction was found in 5ureters .
RESULTS	Univariate and multivariate analyses did not allow identification of any characteristics that could explain the significant difference in the success rates except for the type of product used .
CONCLUSIONS	We present the largest known prospective evaluation comparing 2bulking agents for the treatment of vesicoureteral reflux .
CONCLUSIONS	Endoscopic injection of polydimethylsiloxane resulted in a better success rate than dextranomer/hyaluronic acid copolymer .
CONCLUSIONS	The rate of resolution obtained with the latter is lower than those previously published due to the inclusion of high grade reflux .

###24973340
BACKGROUND	Economic evaluation is important for making decisions about resource allocation .
BACKGROUND	Few cost-utility or cost-effectiveness studies on breast hypertrophy have been reported in the medical literature .
OBJECTIVE	The authors sought to determine the cost-utility of reduction mammaplasty in the Brazilian national health care system .
METHODS	This randomized controlled study was conducted in a university-affiliated hospital .
METHODS	Sixty patients with breast hypertrophy were enrolled prospectively and were assigned randomly to either the control group ( n = 30 patients who received follow-up for 6 months ) or the treatment group ( n = 30 patients who underwent reduction mammaplasty ) .
METHODS	Direct costs were recorded , and the Medical Outcomes Study 36-Item Short-Form Health Survey ( SF-36 ) was administered to both groups at the beginning of the study ( preoperatively for the treatment group ) and 3 and 6 months postoperatively .
METHODS	Utility was determined with Instrument 6D of the Brazilian version of the Short-Form Health Survey ( SF-6D ) , from the SF-36 data .
RESULTS	At the 6-month follow-up , the treatment group showed an improvement in utility , with an average direct cost of approximately 104 .
CONCLUSIONS	Reduction mammaplasty performed in the Brazilian national health care system provides a cost-utility ratio equivalent to approximately 142 per 1 quality-adjusted life year .

###26422874
OBJECTIVE	We aimed to compare the effectiveness of esmolol 1 mg/kg and lidocaine 1 mg/kg for injection pain and for the prevention of rocuronium-induced withdrawal response .
METHODS	We enrolled a total of 81 patients in the study .
METHODS	Patients were randomly assigned to receive either 10 mL of 0.9 % NaCl ( Group P ) , esmolol 1 mg/kg ( Group E ) , or lidocaine 1.0 mg/kg ( Group L ) .
METHODS	A subparalyzing dose of rocuronium 0.05 mg / kg was administered to all patients and its effects were recorded .
METHODS	Anesthesia was induced with intravenous propofol and intravenous rocuronium 0.5 mg/kg in all groups .
METHODS	The withdrawal movements of the patient groups were subsequently graded .
RESULTS	There was a statistically significant difference in overall incidence of pain in group E and L compared to the placebo group after administrating the subparalyzed dose ( no pain response : Group E = 81.5 % , Group L = 77.8 % , Group P = 14.8 % ) ( P < 0.001 ) .
RESULTS	After intravenous administration of an intubating dose of rocuronium , the esmolol group had a significantly lower incidence of withdrawal movement than the other groups ( no response : Group E = 81.5 % , Group L = 63 % , Group P = 22.2 % ) ( P < 0.001 ) .
CONCLUSIONS	We found that esmolol significantly attenuates rocuronium-induced withdrawal movement and also reduces pain when used at subparalyzing doses .

###25701171
BACKGROUND	Necitumumab is a second-generation recombinant human immunoglobulin G1 EGFR monoclonal antibody that competitively inhibits ligand binding .
BACKGROUND	We aimed to compare necitumumab plus pemetrexed and cisplatin with pemetrexed and cisplatin alone in patients with previously untreated , stage IV , non-squamous non-small-cell lung cancer ( NSCLC ) .
METHODS	We did this randomised , open-label , controlled phase 3 study at 103 sites in 20 countries .
METHODS	Patients aged 18 years or older , with an Eastern Cooperative Oncology Group ( ECOG ) performance status of 0-2 and adequate organ function , were randomly assigned 1:1 to treatment with a block randomisation scheme ( block size of four ) via a telephone-based interactive voice-response system or interactive web-response system .
METHODS	Patients received either cisplatin 75 mg/m ( 2 ) and pemetrexed 500 mg/m ( 2 ) on day 1 of a 3-week cycle for a maximum of six cycles alone , or with necitumumab 800 mg on days 1 and 8 .
METHODS	Necitumumab was continued after the end of chemotherapy until disease progression or unacceptable toxic effects .
METHODS	Randomisation was stratified by smoking history , ECOG performance status , disease histology , and geographical region .
METHODS	Patients and study investigators were not masked to group assignment .
METHODS	The primary endpoint was overall survival .
METHODS	Efficacy analyses were by intention to treat .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00982111 .
RESULTS	Between Nov 11 , 2009 , and Feb 2 , 2011 , we randomly assigned 633 patients to receive either necitumumab plus pemetrexed and cisplatin ( n = 315 ) or pemetrexed and cisplatin alone ( n = 318 ) .
RESULTS	Enrolment was stopped on Feb 2 , 2011 , after a recommendation from the independent data monitoring committee .
RESULTS	There was no significant difference in overall survival between treatment groups , with a median overall survival of 113 months ( 95 % CI 95-134 ) in the necitumumab plus pemetrexed and cisplatin group versus 115 months ( 101-131 ) in the pemetrexed and cisplatin group ( hazard ratio 101 [ 95 % CI 084-121 ] ; p = 096 ) .
RESULTS	The incidence of grade 3 or worse adverse events , including deaths , was higher in the necitumumab plus pemetrexed and cisplatin group than in the pemetrexed and cisplatin group ; in particular , deaths regarded as related to study drug were reported in 15 ( 5 % ) of 304 patients in the necitumumab group versus nine ( 3 % ) of 312 patients in the pemetrexed and cisplatin group .
RESULTS	Serious adverse events were likewise more frequent in the necitumumab plus pemetrexed and cisplatin group than in the pemetrexed and cisplatin group ( 155 [ 51 % ] of 304 vs 127 [ 41 % ] of 312 patients ) .
RESULTS	Patients in the necitumumab plus pemetrexed and cisplatin group had more grade 3-4 rash ( 45 [ 15 % ] of 304 vs one [ < 1 % ] of 312 patients in the pemetrexed and cisplatin alone group ) , hypomagnesaemia ( 23 [ 8 % ] vs seven [ 2 % ] patients ) , and grade 3 or higher venous thromboembolic events ( 23 [ 8 % ] vs 11 [ 4 % ] patients ) than did those in the pemetrexed and cisplatin alone group .
CONCLUSIONS	Our findings show no evidence to suggest that the addition of necitumumab to pemetrexed and cisplatin increases survival of previously untreated patients with stage IV non-squamous NSCLC .
CONCLUSIONS	Unless future studies identify potentially useful predictive biomarkers , necitumumab is unlikely to provide benefit in this patient population when combined with pemetrexed and cisplatin .
BACKGROUND	Eli Lilly and Company .

###24603217
BACKGROUND	Current guidelines recommend intensive low-density lipoprotein ( LDL ) cholesterol lowering with statins , with a target of 70 mg/dL ( 1.81 mmol/L ) LDL cholesterol for those with a very high risk of coronary artery events .
BACKGROUND	However , there is no multicenter study assessing the effect of intensive lipid-lowering therapy with statins on acute coronary syndrome ( ACS ) in a Chinese population with low baseline LDL cholesterol levels .
RESULTS	Patients ( n = 1355 ) with ACS were treated with a moderate dose of statin ( atorvastatin 10 mg/d , or equivalent dose of other statins , n = 675 ) or with an intensive dose of statin ( atorvastatin , 20 or 40 mg/d , or equivalent dose of other statins , n = 680 ) for 2 years .
RESULTS	The primary end points were cardiac death , non-fatal acute myocardial infarction ( MI ) , revascularization , ischemic stroke and documented unstable angina or severe heart failure requiring emergency hospitalization .
RESULTS	Baseline lipid levels were nearly identical in both groups with a mean LDL cholesterol level of 2.7 mmol/L ( 103 mg/dL ) .
RESULTS	At 3 months , LDL cholesterol levels declined 20.2 % in the moderate dose statin group and 26.6 % in the intensive statin group , respectively ( P < 0.001 ) .
RESULTS	In a 2-year follow-up , a primary end point event occurred in 20 patients in the moderate dose statin group and in 28 patients in the intensive statin group .
RESULTS	There was no significant between-group difference in the primary outcome ( hazard ratio , 1.39 ; 95 % confidence interval [ CI ] , 0.78-2 .46 ; P = 0.245 ) .
CONCLUSIONS	For ACS patients with a relatively low baseline LDL cholesterol level who received optimized current medication and interventional therapy , the incremental LDL cholesterol reduction of 6.4 % achieved by double-dose statin did not bring significant clinical effectiveness .

###24637058
BACKGROUND	Response to cardiac resynchronization therapy is variable .
BACKGROUND	The aim of this study was to test the hypothesis that left ventricular ( LV ) lead position in proximity to myocardial scar is associated with less favorable outcomes .
METHODS	A total of 149 patients were included in this substudy of the Speckle Tracking Assisted Resynchronization Therapy for Electrode Region trial using echocardiographic radial strain for basal and middle LV segments and transverse strain for apical segments to estimate scar .
METHODS	Sixty-four patients with high-dose rest ( 99m ) Tc sestamibi single-photon emission computed tomographic imaging were used for validation in 508 LV free-wall segments .
METHODS	The relationship of LV lead position to segments estimated as scar was defined as concordant , adjacent , or remote .
METHODS	The prespecified primary end point was heart failure hospitalization or death over 2 years .
RESULTS	Wall thickening < 10 % by radial strain in LV free wall segments was associated with absent ( 99m ) Tc sestamibi uptake indicative of scar with 77 % sensitivity and 89 % specificity and strain < 10 % was accordingly used as the surrogate for scar .
RESULTS	Event-free survival was most favorable in patients with nonischemic disease ( 79 % ) , similarly favorable in patients with ischemic disease and LV leads remote from scar ( 74 % ) , but significantly worse in patients with ischemic disease and LV leads adjacent to ( 61 % ) or within scar ( 41 % ) ( P = .004 ) .
RESULTS	Preserved wall thickening at the LV lead site was independently associated with favorable outcome and additive to pacing at the site of latest mechanical activation ( P = .001 ) and remained significant after adjusting for scar burden .
CONCLUSIONS	Echocardiographic speckle-tracking strain has the potential to estimate free wall scar in patients with ischemic cardiomyopathy and influence LV lead positioning away from scar to improve clinical outcomes after cardiac resynchronization therapy .

###25445405
BACKGROUND	Tripterygium wilfordii Hook .
BACKGROUND	f. ( TwHF ) has been used for many years to induce the remission of Crohn 's disease in China .
OBJECTIVE	To compare TwHF versus azathioprine for the prevention of postoperative recurrence in Crohn 's disease .
METHODS	90 Crohn 's disease patients who had undergone resection were treated with TwHF 1.5 mg/kg/day or azathioprine 2.0 mg/kg/day .
METHODS	The primary endpoint was clinical recurrence , and the secondary endpoint was endoscopic recurrence .
RESULTS	47 patients completed the trial .
RESULTS	Clinical recurrence was observed in 6/45 patients in the TwHF group and 4/45 patients in the azathioprine group at week 26 ( P = 0.74 ) .
RESULTS	At week 52 , 8/45 azathioprine patients and 12/45 TwHF patients had clinical recurrence ( P = 0.45 ) .
RESULTS	During the first 26 weeks , 56.8 % of the patients in the TwHF group versus 47.7 % in the azathioprine group experienced endoscopic recurrence ( P = 0.52 ) .
RESULTS	However , at week 52 , 74.4 % of patients in the TwHF group and 50 % in the azathioprine group had endoscopic recurrence ( P = 0.03 ) .
CONCLUSIONS	TwHF was less effective in maintaining endoscopic remission at week 52 , even though TwHF was comparable to azathioprine for preventing postoperative clinical recurrence .

###25646186
OBJECTIVE	To test the efficacy of meaning-centered group psychotherapy ( MCGP ) to reduce psychological distress and improve spiritual well-being in patients with advanced or terminal cancer .
METHODS	Patients with advanced cancer ( N = 253 ) were randomly assigned to manualized eight-session interventions of either MCGP or supportive group psychotherapy ( SGP ) .
METHODS	Patients were assessed before and after completing the treatment and 2 months after treatment .
METHODS	The primary outcome measures were spiritual well-being and overall quality of life , with secondary outcome measures assessing depression , hopelessness , desire for hastened death , anxiety , and physical symptom distress .
RESULTS	Hierarchical linear models that included a priori covariates and only participants who attended three sessions indicated a significant group time interaction for most outcome variables .
RESULTS	Specifically , patients receiving MCGP showed significantly greater improvement in spiritual well-being and quality of life and significantly greater reductions in depression , hopelessness , desire for hastened death , and physical symptom distress compared with those receiving SGP .
RESULTS	No group differences were observed for changes in anxiety .
RESULTS	Analyses that included all patients , regardless of whether they attended any treatment sessions ( ie , intent-to-treat analyses ) , and no covariates still showed significant treatment effects ( ie , greater benefit for patients receiving MCGP v SGP ) for quality of life , depression , and hopelessness but not for other outcome variables .
CONCLUSIONS	This large randomized controlled study provides strong support for the efficacy of MCGP as a treatment for psychological and existential or spiritual distress in patients with advanced cancer .

###24845600
OBJECTIVE	We investigated the contribution of electrocortical stimulation ( ECS ) , induced high gamma electrocorticography ( hgECoG ) and functional magnetic resonance imaging ( fMRI ) for the localization of somatosensory and language cortex .
METHODS	23 Epileptic patients with subdural electrodes underwent a protocol of somatosensory stimulation and/or an auditory semantic decision task .
METHODS	14 Patients did the same protocol with fMRI prior to implantation .
RESULTS	ECS resulted in the identification of thumb somatosensory cortex in 12/16 patients .
RESULTS	Taking ECS as a gold standard , hgECoG and fMRI identified 53.6 / 33 % of true positive and 4/12 % of false positive contacts , respectively .
RESULTS	The hgECoG false positive sites were all found in the hand area of the post-central gyrus .
RESULTS	ECS localized language-related sites in 7/12 patients with hgECoG and fMRI showing 50/64 % of true positive and 8/23 % of false positive contacts , respectively .
RESULTS	All but one of the hgECoG/fMRI false positive contacts were located in plausible language areas .
RESULTS	Four patients showed post-surgical impairments : the resection included the sites positively indicated by ECS , hgECoG and fMRI in 3 patients and a positive hgECoG site in one patient .
CONCLUSIONS	HgECoG and fMRI provide additional localization information in patients who can not sufficiently collaborate during ECS .
CONCLUSIONS	HgECoG and fMRI make the cortical mapping procedure more flexible not only by identifying priority cortical sites for ECS or when ECS is not feasible , but also when ECS does not provide any result .

###25931463
OBJECTIVE	Tissue factor ( TF ) expression is increased in inflammatory atherosclerotic plaques and has been related to their thrombogenicity .
OBJECTIVE	Blood-borne TF has been also demonstrated to contribute to thrombogenesis .
OBJECTIVE	However , few studies have evaluated the association of circulating levels of TF with stroke .
OBJECTIVE	We investigated the association of baseline circulating levels of TF with stroke events occurred in the European Prospective Investigation into Cancer and Nutrition-Italy cohort .
METHODS	Using a nested case-cohort design , a center-stratified random sample of 839 subjects ( 66 % women ; age range , 35-71 years ) was selected as subcohort and compared with 292 strokes in a mean follow-up of 9 years .
METHODS	Blood samples were collected at baseline in citrate , plasma was stored in liquid nitrogen and TF was measured by ELISA ( IMUBIND , TF ELISA , Instrumentation Laboratory , Milan , Italy ) .
METHODS	The odd ratios and 95 % confidence intervals , adjusted by relevant confounders ( covariates of TF ) and stratified by center , were estimated by a Cox regression model using Prentice method .
RESULTS	Individuals in the highest compared with the lowest quartile of TF plasma levels had significantly increased risk of stroke ( odds ratioIVvsI quartile , 2.01 ; 95 % confidence interval , 1.25-3 .23 ) .
RESULTS	The association was independent from several potential confounders ( odds ratioIVvsI quartile , 1.91 ; 95 % confidence interval , 1.15-3 .19 ) .
RESULTS	No differences were observed between men and women .
RESULTS	The increase in risk was restricted to ischemic strokes ( odds ratioIVvsI quartile , 2.13 ; 95 % confidence interval , 1.10-4 .12 ; fully adjusted model ) , whereas high levels of TF were not associated with the risk of hemorrhagic stroke ( odds ratioIVvsI quartile , 1.12 ; 95 % confidence interval , 0.49-2 .55 ; fully adjusted model ) .
CONCLUSIONS	Our data provide evidence that elevated levels of circulating TF are potential risk factors for ischemic strokes .

###24320695
OBJECTIVE	Recently , the usefulness of neuromuscular electrical stimulation and repetitive transcranial magnetic stimulation for poststroke dysphagia has been reported .
OBJECTIVE	However , there is no report that describes the effectiveness of functional magnetic stimulation ( FMS ) for dysphagia .
OBJECTIVE	The purpose of this study is to clarify the effectiveness of FMS for poststroke dysphagia .
METHODS	Twenty poststroke dysphagic patients ( age at treatment : 51-80 years ; interval between onset of stroke and treatment : 6 to 36 months ) were randomly assigned to a real group or a sham group .
METHODS	In the real group , FMS of 30 Hz was applied for suprahyoid muscles in a 20-sec train using a parabolic coil for 10 min ( total 1200 pulses ) .
METHODS	In the sham group , sham stimulation was applied for 10 min at the same site .
METHODS	Swallowing function was evaluated by the timed water swallow test , interswallow interval ( ISI ) , swallowing volume velocity ( speed ) , and volume per swallow ( capacity ) were measured before and after stimulation .
RESULTS	All patients completed the stimulation and none showed any adverse reactions throughout the stimulation .
RESULTS	The improvement of speed and capacity of swallowing after stimulation was significantly larger in the real group compared with the sham group ( all p < 0.05 ) .
RESULTS	However , no significant difference in the ISI was found between the groups .
CONCLUSIONS	FMS using a parabolic coil can potentially improve swallowing function in poststroke dysphagic patients .

###24783923
OBJECTIVE	To observe the clinical efficacy and safety of Traditional Chinese Medicine ( TCM ) combined with Western Medicine ( WM ) in patients with diabetic acute ischemic stroke .
METHODS	Ninety patients with diabetic acute ischemic stroke were randomly divided into a treatment group and a control group .
METHODS	The 45 patients in the treatment group were given standardized treatment with TCM combined with WM. They received corresponding oral Chinese decoctions three times daily , according to their TCM syndromes , along with basic western medical treatment .
METHODS	The 45 patients in the control group were given non-standardized treatment with TCM combined with WM. They received an oral Chinese decoction for promotion of blood circulation to inhibit hemostasis , regardless of their TCM syndromes , along with basic western medical treatment .
METHODS	The treatments lasted for 4 weeks .
METHODS	Scores were evaluated on the National Institutes of Health Stroke Scale ( NIHSS ) score , activity of daily life ( ADL ) scores , and TCM symptoms before treatment and 2 and 4 weeks after treatment .
RESULTS	Analysis of variance for repeated measurements showed that there were significant differences in NIHSS and ADL score before and after treatment in both groups ( P < 0.05 ) .
RESULTS	There were also significant differences between the scores at 2 and 4 weeks after treatment .
RESULTS	There were significant differences in TCM syndrome scores before and after treatment in both groups ( P < 0.05 ) .
RESULTS	There were also significant differences between the scores at 2 and 4 weeks after treatment .
RESULTS	The X2 test showed no statistically significant difference in the incidence of adverse reactions between the two groups ( P > 0.05 ) .
CONCLUSIONS	Standardized treatment was superior to non-standardized treatment for clinical efficacy of TCM combined with WM in patients with diabetic acute ischemic stroke , and the superiority was more obvious in improving neural dysfunction , ADL score , and TCM symptoms .
CONCLUSIONS	The adverse reactions were similar in the two treatment groups .

###24625273
BACKGROUND	Subacromial impingement syndrome is the most frequent cause of shoulder problems which themselves affect 1 in 3 adults .
BACKGROUND	Management commonly includes exercise and corticosteroid injection .
BACKGROUND	However , the few existing trials of exercise or corticosteroid injection for subacromial impingement syndrome are mostly small , of poor quality , and focus only on short-term results .
BACKGROUND	Exercise packages tend to be standardised rather than individualised and progressed .
BACKGROUND	There has been much recent interest in improving outcome from corticosteroid injections by using musculoskeletal ultrasound to guide injections .
BACKGROUND	However , there are no high-quality trials comparing ultrasound-guided and blind corticosteroid injection in subacromial impingement syndrome .
BACKGROUND	This trial will investigate how to optimise the outcome of subacromial impingement syndrome from exercise ( standardised advice and information leaflet versus physiotherapist-led exercise ) and from subacromial corticosteroid injection ( blind versus ultrasound-guided ) , and provide long-term follow-up data on clinical and cost-effectiveness .
METHODS	The study design is a 2x2 factorial randomised controlled trial .
METHODS	252 adults with subacromial impingement syndrome will be recruited from two musculoskeletal Clinical Assessment and Treatment Services at the primary-secondary care interface in Staffordshire , UK .
METHODS	Participants will be randomised on a 1:1:1:1 basis to one of four treatment groups : ( 1 ) ultrasound-guided subacromial corticosteroid injection and a physiotherapist-led exercise programme , ( 2 ) ultrasound-guided subacromial corticosteroid injection and an advice and exercise leaflet , ( 3 ) blind subacromial corticosteroid injection and a physiotherapist-led exercise programme , or ( 4 ) blind subacromial corticosteroid injection and an advice and exercise leaflet .
METHODS	The primary intention-to-treat analysis will be the mean differences in Shoulder Pain and Disability Index ( SPADI ) scores at 6 weeks for the comparison between injection interventions and at 6 months for the comparison between exercise interventions .
METHODS	Although independence of treatment effects is assumed , the magnitude of any interaction effect will be examined ( but is not intended for the main analyses ) .
METHODS	Secondary outcomes will include comparison of long-term outcomes ( 12 months ) and cost-effectiveness .
METHODS	A secondary per protocol analysis will also be performed .
CONCLUSIONS	This protocol paper presents detail of the rationale , design , methods and operational aspects of the SUPPORT trial .
BACKGROUND	Current controlled trials ISRCTN42399123 .

###24961194
OBJECTIVE	Pre-clinical work suggests that upper thoracic spinal cord stimulation ( SCS ) may have therapeutic effects in the treatment of heart failure ( HF ) .
OBJECTIVE	We therefore aim to assess the safety and feasibility of SCS in HF patients .
RESULTS	A prospective , randomized , double-blind , crossover pilot study was conducted in symptomatic HF patients receiving optimal medical therapy .
RESULTS	Patients were implanted with an SCS system and randomized to an SCS-ACTIVE , delivered at 90 % paraesthesia threshold , or an SCS-INACTIVE phase for 3 months , followed by a 1-month washout period and crossover to the alternative phase .
RESULTS	The safety of SCS therapy was assessed by death and cardiac events .
RESULTS	Implantable cardioverter defibrillator ( ICD ) function in the presence of SCS was tested by defibrillation testing during SCS system implant and review of real-time and stored electrograms during follow-up .
RESULTS	The efficacy of SCS therapy was assessed by changes in patient symptoms , LV function , and BNP level .
RESULTS	Nine patients were investigated .
RESULTS	In all cases , ICD sensing , detection , and therapy delivery were unaffected by SCS .
RESULTS	During follow-up , one patient died and one was hospitalized for HF while in the SCS-INACTIVE phase , and two patients had HF hospitalizations during the SCS-ACTIVE phase .
RESULTS	Symptoms were improved in the majority of patients with SCS , while markers of cardiac structure and function were , in aggregate , unchanged .
CONCLUSIONS	This study shows that an SCS system can be safely implanted in patients with advanced HF and that the SCS system does not interfere with ICD function .

###24749843
BACKGROUND	A recent noninferiority randomized trial showed that in terms of clinical effectiveness imiquimod was superior and topical fluorouracil noninferior to methylaminolaevulinate photodynamic therapy ( MAL-PDT ) for treatment of superficial basal-cell carcinoma ( sBCC ) .
BACKGROUND	Although it was expected that MAL-PDT would be more costly than either cream , a full cost-effectiveness analysis is necessary to determine the balance between effectiveness and costs .
OBJECTIVE	To determine whether imiquimod or topical fluorouracil are cost-effective treatments for sBCC compared with MAL-PDT .
METHODS	An economic evaluation was performed from a healthcare perspective .
METHODS	Data on resource use and costs were collected alongside the randomized clinical trial .
METHODS	The incremental cost-effectiveness ratio was expressed as the incremental costs per additional patient free of tumour recurrence .
RESULTS	At 12 months follow-up , the total mean costs for MAL-PDT were 680 , for imiquimod cream 526 and for topical fluorouracil cream 388 .
RESULTS	Both imiquimod and topical fluorouracil were cost-effective treatments compared with MAL-PDT .
RESULTS	Comparing costs and effectiveness of both creams led to a incremental investment of 4451 to achieve an additional patient free of tumour recurrence .
RESULTS	The acceptability curve showed that , for a threshold value of 4451 , the probability of imiquimod being more cost-effective than topical fluorouracil was 50 % .
CONCLUSIONS	Based on the 12 months follow-up results , imiquimod and topical fluorouracil cream are more cost-effective than MAL-PDT for treatment of sBCC .
CONCLUSIONS	Hence , substituting MAL-PDT with either imiquimod or topical fluorouracil results in cost savings ; these savings will be larger for topical fluorouracil .
CONCLUSIONS	Long-term follow-up effectiveness data are necessary to confirm the cost-effectiveness of imiquimod vs. topical 5-fluorouracil cream .

###24795515
BACKGROUND	Due to increasing resistance to antibiotics and rising incidence of oral diseases , there is a need for alternative treatment modalities to combat oral diseases .
BACKGROUND	The aim of the present study was to access the effect of Aloe vera mouthwash on the dental plaque in the experimental period of 4 days and to compare it with the bench mark control chlorhexidine and placebo ( saline water ) .
METHODS	A total of 300 systemically healthy subjects were randomly allocated into 3 groups : Aloe vera mouthwash group ( n = 100 ) , control group ( = 100 ) - chlorhexidene group and saline water-Placebo ( n = 100 ) .
METHODS	To begin with , Gingival index ( GI ) and plaque index ( PI ) were recorded .
METHODS	Then , baseline plaque scores were brought to zero by professionally cleaning the teeth with scaling and polishing .
METHODS	After randomization of the participants into three groups they were refrained from regular mechanical oral hygiene measures .
METHODS	Subjects were asked to swish with respective mouthwash ( Aloe vera mouthwash , 0.2 % chlorhexidine gluconate mouthwash , or normal saline ) as per therapeutic dose for 4 days .
RESULTS	The results showed that Aloe vera mouthrinse is equally effective in reducing plaque as Chlorhexidine compared to placebo over a period of 4 days .
RESULTS	There was a significant reduction on plaque in Aloe vera and chlorhexidine groups and no statistically significant difference was observed among them ( p > 0.05 ) .
RESULTS	Aloe vera mouthwash showed no side effects .
CONCLUSIONS	The results of the present study indicated that Aloe vera may prove an effective mouthwash due to its ability in reducing dental plaque .

###25157768
BACKGROUND	The phase 3 MONET1 study evaluated motesanib ( a small-molecule inhibitor of vascular endothelial growth factor receptors ) plus carboplatin/paclitaxel versus placebo plus carboplatin/paclitaxel as first-line therapy for advanced non-small-cell lung cancer ( NSCLC ) .
BACKGROUND	Treatment and enrollment of patients with squamous histology were permanently discontinued following higher early mortality and gross hemoptysis in those with squamous NSCLC who received motesanib .
BACKGROUND	Enrollment of patients with nonsquamous histology was temporarily halted , but resumed following a protocol amendment ( Scagliotti et al. .
BACKGROUND	J Clin Oncol .
BACKGROUND	2012 ; 30:2829 -2836 ) .
BACKGROUND	Herein , we report data from the squamous cohort .
METHODS	Patients with stage IIIB/IV or recurrent squamous NSCLC ( without prior systemic therapy for advanced disease ) received up to six 3-week cycles of chemotherapy ( carboplatin , area under the curve 6 mg/mLmin/paclitaxel , 200 mg/m ) and were randomized 1:1 to receive motesanib 125 mg ( Arm A ) or placebo ( Arm B ) once daily .
METHODS	The primary end point was overall survival .
RESULTS	Three-hundred and sixty patients with squamous NSCLC were randomized ( Arm A , n = 182 ; Arm B , n = 178 ) between July 2007 and November 2008 .
RESULTS	Twenty-three patients ( 13 % ) in Arm A and 10 ( 6 % ) in Arm B had fatal adverse events within the first 60 days of treatment .
RESULTS	Among these , six patients in Arm A , but none in Arm B , had fatal bleeding events .
RESULTS	At final analysis , serious adverse events had occurred in 47 % of patients in Arm A and 29 % of patients in Arm B. Median overall survival was similar in Arms A and B ( 11.1 versus 10.7 months ) .
CONCLUSIONS	Motesanib plus carboplatin/paclitaxel had unacceptable toxicity compared with carboplatin/paclitaxel alone in patients with advanced squamous NSCLC .

###25209438
BACKGROUND	Roux-en-Y gastric bypass may lead to impaired calcium uptake .
BACKGROUND	Therefore , operation-specific effects of gastric bypass and vertical banded gastroplasty on bone mineral density ( BMD ) were examined in a randomized clinical trial .
BACKGROUND	Bone resorption markers and mechanisms of decreased calcium uptake after gastric bypass were investigated using blood and endoscopic samples from two additional patient cohorts .
METHODS	Total BMD and non-weight-bearing skull BMD were measured by dual-energy X-ray absorptiometry at baseline , and 1 and 6years after gastric bypass or vertical banded gastroplasty in patients who were not receiving calcium supplements .
METHODS	Bone resorption markers in serum and calcium uptake mechanisms in jejunal mucosa biopsies were analysed after gastric bypass by proteomics including radioimmunoassay , gel electrophoresis and mass spectrometry .
RESULTS	One year after surgery , weight loss was similar after gastric bypass and vertical banded gastroplasty .
RESULTS	There was a moderate decrease in skull BMD after gastric bypass , but not after vertical banded gastroplasty ( P < 0001 ) .
RESULTS	Between 1 and 6years after gastric bypass , skull BMD and total BMD continued to decrease ( P = 0001 ) .
RESULTS	C-terminal telopeptide levels in serum had increased twofold by 18months after gastric bypass .
RESULTS	Proteomic analysis of the jejunal mucosa revealed decreased levels of heat-shock protein 90 , a co-activator of the vitamin D receptor , after gastric bypass .
RESULTS	Despite increased vitamin D receptor levels , expression of the vitamin D receptor-regulated calcium transporter protein TRPV6 decreased .
CONCLUSIONS	BMD decreases independently of weight after gastric bypass .
CONCLUSIONS	Bone loss might be attributed to impaired calcium absorption caused by decreased activation of vitamin D-dependent calcium absorption mechanisms mediated by heat-shock protein 90 and TRPV6 .

###26017057
OBJECTIVE	The metastatic status of regional lymph nodes is the most relevant prognostic factor in breast cancer , melanoma , and other solid organ tumors with a lymphatic spread .
OBJECTIVE	The current gold standard for detection and targeted excision of the sentinel lymph node is preoperative lymphoscintigraphy with technetium Tc 99m .
OBJECTIVE	Because of the worldwide shortage of technetium Tc 99m , physicians are looking for nonradioactive dyes for sentinel lymph node labeling .
OBJECTIVE	Based on several retrospective studies , the fluorescent dye indocyanine green is considered a possible alternative to technetium Tc 99m .
OBJECTIVE	To analyze the feasibility and clinical benefit of intraoperative near infrared fluorescence sentinel lymph node excision ( SLNE ) compared with standard technetium Tc 99m-guided SLNE using malignant melanoma in which SLNE is firmly established .
METHODS	Analysis of a prospective clinical trial at the Skin Cancer Center , University Hospital Essen .
METHODS	Eighty patients with malignant melanoma on the trunk or extremities ( upper and lower ) who were scheduled to undergo SLNE were included in this study from January 1 , 2013 , to June 27 , 2014 .
METHODS	Concordance of preoperative and intraoperative sentinel lymph node detection rates .
RESULTS	During the study period , 80 patients were operated on with an additional intraoperative application of a near infrared fluorescent dye .
RESULTS	In these 80 surgical procedures , 147 SLNs were excised .
RESULTS	Detection of a technetium Tc 99m-marked SLN before surgery was possible in all cases .
RESULTS	Intraoperative visualization of the SLN by indocyanine green before skin incision was successful in only 17 of 80 patients ( 21 % ) .
RESULTS	The number of SLNs identified using the near infrared fluorescence technique in the operative site after skin incision and initial tissue preparation was 141 of 147 ( 96 % ) .
CONCLUSIONS	Among patients in whom the lymph node basin can not be predicted correctly ( eg , in cutaneous melanoma on the trunk ) , the use of indocyanine green for SLN detection is severely limited compared with SLNE using standard technique guided by technetium Tc 99m .
CONCLUSIONS	Therefore , SLNE with the use of radiocolloid , followed if possible by single-photon emission computed tomography , remains the gold standard .
BACKGROUND	German Clinical Trials Register identifier DRKS00004619 .

###24552979
OBJECTIVE	Osteoporosis and atherosclerosis are the two most common diseases in postmenopausal women .
OBJECTIVE	In most cases , they are simultaneously present in the same individual and commonly lead to bone fracture or cardiovascular disease ( CVD ) .
OBJECTIVE	Bisphosphonates ( BPs ) are frequently used in the treatment of osteoporosis and have the ability to increase lumbar spine bone mineral density ( L-BMD ) .
OBJECTIVE	BPs may also protect against CVD .
OBJECTIVE	A single monthly 50-mg dose of minodronate ( monthly minodronate ) is now common practice and is highly anticipated to reduce the incidence of both bone fracture and CVD .
OBJECTIVE	A useful approach to independently predicting CVD is brachial-ankle pulse wave velocity ( baPWV ) .
OBJECTIVE	Here , we directly compared the effects of monthly minodronate with those of a standard single weekly 35-mg dose of alendronate ( weekly alendronate ) on L-BMD and baPWV in postmenopausal women with osteoporosis across a 12-month period .
METHODS	Thirty-eight postmenopausal women with osteoporosis were randomized into two treatment groups ( group 1 , weekly alendronate , n = 19 ; group 2 , monthly minodronate , n = 19 ) .
METHODS	L-BMD and baPWV were assessed at baseline and 12-month follow-up .
RESULTS	At the end of the 12-month period , increases in L-BMD were similar between group 1 ( 7.6 % ) and group 2 ( 8.5 % ) , but baPWV was significantly reduced in group 2 compared with group 1 .
RESULTS	The change in baPWV during the study period showed a significant negative correlation with the change in L-BMD .
CONCLUSIONS	Changes in L-BMD in the monthly minodronate and weekly alendronate groups are generally comparable .
CONCLUSIONS	Good control of changes in L-BMD in the postmenopausal phase might be associated with regression of CVD .
CONCLUSIONS	Monthly minodronate is a promising new BP and potential first-line drug for the treatment of osteoporosis in postmenopausal women .

###24565346
OBJECTIVE	Knee anterior cruciate ligament reconstruction ( ACLR ) may be painful in the postoperative period .
OBJECTIVE	The primary objective of this study was to evaluate whether the use of femoral nerve block ( FNB ) associated with spinal anesthesia would improve the postoperative pain treatment in ACLR and the secondary objectives were to evaluate tramadol request and adverse events .
METHODS	53 patients were randomly divided into two groups : GA ( n = 26 ) received spinal anesthesia and GB ( n = 27 ) received spinal anesthesia and FNB .
METHODS	All patients received multimodal analgesia and rescue analgesics could be requested anytime .
METHODS	Assessments were performed at 6 , 12 and 24 hours .
RESULTS	There was no difference between both groups regarding demographic and clinical - surgical variables .
RESULTS	There was no difference between groups regarding pain intensity .
RESULTS	Mean pain scores were higher at 12 hours in GA and there was no change in GB ; 55.6 % of patients reported moderate pain in GA and 53.8 % mild pain in GB .
RESULTS	There was no difference regarding tramadol request .
RESULTS	There were no serious adverse events : 80.8 % of patients in GB had motor block of the thigh and two fell .
CONCLUSIONS	Analgesia was more effective with the combination of spinal and FNB , which allowed better control of postoperative pain , assessed 12 hours after anesthesia .
CONCLUSIONS	There was no difference in tramadol request .
CONCLUSIONS	Patients in this study had no serious adverse events ; however , one must be attentive to motor paralysis and the possibility of falling when FNB is performed .

###24560487
OBJECTIVE	We compared biweekly irinotecan plus cisplatin ( BIRIP ) with irinotecan alone as the second-line chemotherapy ( SLC ) for advanced gastric cancer ( AGC ) .
METHODS	Patients with metastatic or recurrent gastric cancer refractory to S-1-based first-line chemotherapy were randomly assigned to receive BIRIP ( irinotecan 60mg/m ( 2 ) plus cisplatin 30mg/m ( 2 ) , every 2weeks ) or irinotecan alone ( irinotecan 150mg/m ( 2 ) , every 2weeks ) .
METHODS	The primary end-point was to show the superiority of BIRIP to irinotecan in terms of progression free survival ( PFS ) .
RESULTS	130 patients were enrolled .
RESULTS	PFS was significantly longer in the BIRIP group ( 3.8 months [ 95 % confidence interval ( CI ) 3.0-4 .7 ] ) than in the irinotecan group ( 2.8 months [ 2.1-3 .3 ] ; hazard ratio 0.68 , 95 % CI 0.47-0 .98 ; P = 0.0398 ) .
RESULTS	Median overall survival was 10.7 months in the BIRIP group and 10.1 months in the irinotecan group ( HR 1.00 , 95 % CI 0.69-1 .44 , P = 0.9823 ) .
RESULTS	The objective response rate was 22 % in the BIRIP group and 16 % in the irinotecan group ( P = 0.4975 ) .
RESULTS	However , the disease control rate was significantly better in the BIRIP group ( 75 % ) than in the irinotecan group ( 54 % , P = 0.0162 ) .
RESULTS	The incidences of grade 3 or worse adverse events did not differ between the two groups .
RESULTS	Any grade elevation of serum creatinine was more common in the BIRIP group ( 25 % versus 8 % , P = 0.009 ) , but any grade diarrhoea ( 17 % versus 42 % , P = 0.002 ) was more common in the irinotecan group .
CONCLUSIONS	BIRIP significantly prolonged PFS as compared with irinotecan alone and was tolerated as SLC , but did not demonstrate the survival benefit in this trial .

###24767476
BACKGROUND	Hypertension is the leading global risk factor for mortality .
BACKGROUND	Hypertension treatment and control rates are low worldwide , and delays in seeking care are associated with increased mortality .
BACKGROUND	Thus , a critical component of hypertension management is to optimize linkage and retention to care .
METHODS	This study investigates whether community health workers , equipped with a tailored behavioral communication strategy and smartphone technology , can increase linkage and retention of hypertensive individuals to a hypertension care program and significantly reduce blood pressure among them .
METHODS	The study will be conducted in the Kosirai and Turbo Divisions of western Kenya .
METHODS	An initial phase of qualitative inquiry will assess facilitators and barriers of linkage and retention to care using a modified Health Belief Model as a conceptual framework .
METHODS	Subsequently , we will conduct a cluster randomized controlled trial with three arms : 1 ) usual care ( community health workers with the standard level of hypertension care training ) ; 2 ) community health workers with an additional tailored behavioral communication strategy ; and 3 ) community health workers with a tailored behavioral communication strategy who are also equipped with smartphone technology .
METHODS	The co-primary outcome measures are : 1 ) linkage to hypertension care , and 2 ) one-year change in systolic blood pressure among hypertensive individuals .
METHODS	Cost-effectiveness analysis will be conducted in terms of costs per unit decrease in blood pressure and costs per disability-adjusted life year gained .
CONCLUSIONS	This study will provide evidence regarding the effectiveness and cost-effectiveness of strategies to optimize linkage and retention to hypertension care that can be applicable to non-communicable disease management in low - and middle-income countries .
BACKGROUND	This trial is registered with ( NCT01844596 ) on 30 April 2013 .

###24879975
BACKGROUND	Inotropes are widely used in hospitalized systolic heart failure ( HF ) patients , especially those with low systolic blood pressure ( SBP ) or cardiac index .
BACKGROUND	In addition , inotropes are considered to be harmful in nonischemic HF .
RESULTS	We examined the association of in-hospital inotrope use with ( 1 ) major events ( death , ventricular assist device , or heart transplant ) and ( 2 ) study days alive and out of hospital during the first 6 months in the Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness , which excluded patients with immediate need for inotropic therapy .
RESULTS	Predefined subgroups of interest were baseline SBP < 100 versus 100 mm Hg , cardiac index < 1.8 vs 1.8 L min ( -1 ) m ( -2 ) , and ischemic versus nonischemic HF etiology .
RESULTS	Inotropes were frequently used in both the < 100 mm Hg ( 88/165 [ 53.3 % ] ) and the 100 mm Hg ( 106/262 [ 40.5 % ] ) SBP subgroups and were associated with higher risk for major events in both subgroups ( adjusted hazard ratio [ HR ] 2.85 , 95 % confidence interval [ CI ] 1.59-5 .12 [ P < .001 ] ; and HR 1.86 , 95 % CI 1.02-3 .37 [ P = .042 ] ; respectively ) .
RESULTS	Risk with inotropes was more pronounced among those with cardiac index 1.8 L min ( -1 ) m ( -2 ) ( n = 114 ; HR 4.65 , 95 % CI 1.98-10 .9 ; P < .001 ) vs < 1.8 L min ( -1 ) m ( -2 ) ( n = 82 ; HR 1.48 , 95 % CI 0.61-3 .58 ; P = .39 ) .
RESULTS	Event rates were higher with inotropes in both ischemic ( n = 215 ; HR 2.64 , 95 % CI 1.49-4 .68 ; P = .001 ) and nonischemic ( n = 216 ; HR 2.19 , 95 % CI 1.18-4 .07 ; P = .012 ) patients .
RESULTS	Across all subgroups , patients who received inotropes spent fewer study days alive and out of hospital .
CONCLUSIONS	In the absence of cardiogenic shock or end-organ hypoperfusion , inotrope use during hospitalization for HF was associated with unfavorable 6-month outcomes , regardless of admission SBP , cardiac index , or HF etiology .

###24837977
BACKGROUND	Home mechanical ventilation is usually initiated in hospital .
BACKGROUND	However , cost-effectiveness of inpatient set up has never been compared to outpatient adaptation in a randomized design .
BACKGROUND	A Prospective , multicenter , non-inferiority trial was conducted comparing the effectiveness of adaptation to noninvasive mechanical ventilation ( NIMV ) performed in the ambulatory or hospital setting in patients with chronic respiratory failure secondary to restrictive thoracic disease , obesity-hypoventilation syndrome or neuromuscular disease .
METHODS	The study included 53 candidates for NIMV , randomized to ambulatory adaptation ( AA ) ( n = 27 ) or hospital adaptation ( HA ) ( n = 26 ) .
METHODS	The patients ' characteristics were recorded before establishing ventilation and at 1 and 6 months after .
METHODS	The main outcome variable was PaCO2 decrease at 6 months following initiation of NIMV .
METHODS	The direct costs of the two interventions were compared .
RESULTS	Before starting NIMV , PaCO2 was 50.46.8 mmHg in the AA group and 50.35.7 mmHg in the HA group .
RESULTS	At 6 months of NIMV use , a significant improvement in PaCO2 relative to baseline was found in both groups : mean ( 95 % CI ) PaCO2 decrease was 4.9 ( 2.3 ; 7.4 ) mmHg in AA and 3.3 ( 1.4 ; 5.1 ) mmHg in HA .
RESULTS	The direct calculated cost was 1500 euros per patient in AA and 2692 euros per patient in HA .
CONCLUSIONS	Adaptation to NIMV in the ambulatory setting is not inferior to hospital adaptation in terms of therapeutic equivalence in stable patients with chronic respiratory failure secondary to restrictive thoracic disease , obesity-hypoventilation syndrome or neuromuscular disease .
CONCLUSIONS	Outpatient adaptation may represent a cost saving for the healthcare system .
BACKGROUND	Identifier number NCT00698958 at www.clinicaltrials.gov .

###25716210
OBJECTIVE	Emergency medical research performed under federal regulation 21 CFR 50.24 provides a means to protect human subjects and investigate novel time-sensitive treatments .
OBJECTIVE	Although prospective individual consent is not required for studies conducted under this regulation , consent from a legally authorized representative ( LAR ) or the patient at the earliest feasible opportunity is required to obtain short - and long-term outcome data .
OBJECTIVE	The objective of this study was to determine which demographic , cardiac arrest , and patient outcome characteristics predicted the likelihood of obtaining informed consent following enrollment under exception from informed consent in a multicenter cardiac arrest study .
METHODS	This investigation was an analysis of data collected during a multisite , randomized , controlled , out-of-hospital cardiac arrest clinical trial performed under 21 CFR 50.24 .
METHODS	Research personnel attempted to obtain informed consent from LARs and subjects for medical records review of primary outcome data , as well as consent for neurologic outcome assessments up to 1 year post-cardiac arrest .
METHODS	Hospital discharge and neurologic status were obtained from public records and/or medical records up until the time consent was formally denied , in accordance with federal regulations and guidance .
METHODS	Local institutional review boards also allowed medical records review for cases where consent was neither obtained nor declined despite multiple consent attempts .
METHODS	Patient demographic , cardiac arrest , and clinical outcome characteristics were analyzed in univariate multinomial regression models , with consent status ( obtained , denied , neither obtained nor denied ) as the dependent variable .
METHODS	A multivariate multinomial logistic regression was then performed .
METHODS	An exploratory secondary analysis following the same process was performed after assigning patients who neither consented nor declined to the declined consent group .
RESULTS	Among a total study population of 1,655 cardiac arrest subjects , 457 were transported and had consent attempted ( 27.6 % ) .
RESULTS	The survival status and neurologic function at the time of hospital discharge were known in 440 of 457 ( 96 % ) subjects .
RESULTS	In the multivariate analysis , initial rhythm of ventricular fibrillation/ventricular tachycardia ( VF/VT ) and survival with good neurologic outcome were strong predictors of obtaining consent ( odds ratio [ OR ] = 3.15 , 95 % confidence interval [ CI ] = 1.73 to 5.75 ; OR = 7.64 , 95 % CI = 2.28 to 25.63 , respectively ) .
RESULTS	The exploratory secondary analysis also showed initial rhythm of VF/VT and survival with good neurologic outcome as strong predictors of obtaining consent ( OR = 1.86 , 95 % CI = 1.17 to 2.95 ; OR = 4.52 , 95 % CI = 2.21 to 9.26 , respectively ) .
CONCLUSIONS	Initial arrest rhythm and survival with good neurologic outcome were highly predictive of obtaining consent in this cardiac arrest trial .
CONCLUSIONS	This phenomenon could result in underrepresentation of outcome data in the study arm with the worse outcome and represents a significant potential confounder in studies performed under 21 CFR 50.24 .
CONCLUSIONS	Future revisions to the exception from informed consent regulations should allow access to critical survival data recorded as part of standard documentation , regardless of patient consent status .

###24330729
BACKGROUND	Cancer and other chronic diseases reduce quality and length of life and productivity , and represent a significant financial burden to society .
BACKGROUND	Evidence-based public health approaches to prevent cancer and other chronic diseases have been identified in recent decades and have the potential for high impact .
BACKGROUND	Yet , barriers to implement prevention approaches persist as a result of multiple factors including lack of organizational support , limited resources , competing emerging priorities and crises , and limited skill among the public health workforce .
BACKGROUND	The purpose of this study is to learn how best to promote the adoption of evidence based public health practice related to chronic disease prevention .
METHODS	This paper describes the methods for a multi-phase dissemination study with a cluster randomized trial component that will evaluate the dissemination of public health knowledge about evidence-based prevention of cancer and other chronic diseases .
METHODS	Phase one involves development of measures of practitioner views on and organizational supports for evidence-based public health and data collection using a national online survey involving state health department chronic disease practitioners .
METHODS	In phase two , a cluster randomized trial design will be conducted to test receptivity and usefulness of dissemination strategies directed toward state health department chronic disease practitioners to enhance capacity and organizational support for evidence-based chronic disease prevention .
METHODS	Twelve state health department chronic disease units will be randomly selected and assigned to intervention or control .
METHODS	State health department staff and the university-based study team will jointly identify , refine , and select dissemination strategies within intervention units .
METHODS	Intervention ( dissemination ) strategies may include multi-day in-person training workshops , electronic information exchange modalities , and remote technical assistance .
METHODS	Evaluation methods include pre-post surveys , structured qualitative phone interviews , and abstraction of state-level chronic disease prevention program plans and progress reports .
BACKGROUND	clinicaltrials.gov : NCT01978054 .

###24368638
OBJECTIVE	To prospectively evaluate the survival benefit of dissection of the nerve plexus and lymphadenectomy in patients with pancreatic head cancer .
BACKGROUND	Despite randomized controlled trials on the extent of surgery in pancreatic cancer , attempts have been made to perform more extended resections .
METHODS	A total of 244 patients were enrolled ; of these , 200 were randomized to undergo standard resection or extended resection , with the latter including the dissection of additional lymph nodes and the right half of the nerve plexus around the superior mesenteric artery and celiac axis .
METHODS	We evaluated 167 patients from 7 centers who fulfilled all of the required criteria .
RESULTS	Operation time was longer and estimated blood loss was higher in the extended resection group than in the standard resection group , but the R0 resection rate was comparable .
RESULTS	The mean number of lymph nodes retrieved per patient was higher in the extended resection group than in the standard resection group ( 33.7 vs 17.3 ; P < 0.001 ) .
RESULTS	The morbidity rate was slightly higher in the extended resection group than in the standard resection group .
RESULTS	Two patients in the extended resection group died in hospital .
RESULTS	Median survival after R0 resection was similar in the extended resection and standard resection groups ( 18.0 vs 19.0 months ; P = 0.239 ) regardless of lymph node metastasis .
RESULTS	Adjuvant chemoradiation had a positive impact on overall survival .
CONCLUSIONS	This study suggests that extended lymphadenectomy with dissection of the nerve plexus does not provide a significant survival benefit compared with standard resection in pancreatic head cancer .
CONCLUSIONS	Standard resection can be performed safely and efficiently , without negatively affecting oncologic efficacy or long-term survival , when compared with extended pancreaticoduodenal resection .
CONCLUSIONS	( NCT00679913 ) ?

###24991557
OBJECTIVE	This proof-of-concept study investigated whether feedback-mediated exercise ( FME ) of the affected arm of hemiplegic patients increases patient motivation and promotes greater improvement of motor function , compared to no-feedback exercise ( NFE ) .
METHODS	We developed a feedback-mediated treatment that uses gaming scenarios and allows online and offline monitoring of both temporal and spatial characteristics of planar movements .
METHODS	Twenty poststroke hemiplegic inpatients , randomly assigned to the FME and NFE group , received therapy five days a week for three weeks .
METHODS	The outcome measures were evaluated from the following : ( 1 ) the modified drawing test ( mDT ) , ( 2 ) received therapy time-RTT , and ( 3 ) intrinsic motivation inventory-IMI .
RESULTS	The FME group patients showed significantly higher improvement in the speed metric ( P < 0.01 ) , and smoothness metric ( P < 0.01 ) , as well as higher RTT ( P < 0.01 ) .
RESULTS	Significantly higher patient motivation is observed in the FME group ( interest/enjoyment subscale ( P < 0.01 ) and perceived competence subscale ( P < 0.01 ) ) .
CONCLUSIONS	Prolonged endurance in training and greater improvement in certain areas of motor function , as well as very high patient motivation and strong positive impressions about the treatment , suggest the positive effects of feedback-mediated treatment and its high level of acceptance by patients .

###24668203
OBJECTIVE	About one half of those who develop adult-onset moyamoya disease experience intracranial hemorrhage .
OBJECTIVE	Despite the extremely high frequency of rebleeding attacks and poor prognosis , measures to prevent rebleeding have not been established .
OBJECTIVE	The purpose of this study is to determine whether extracranial-intracranial bypass can reduce incidence of rebleeding and improve patient prognosis .
METHODS	This study was a multicentered , prospective , randomized , controlled trial conducted by 22 institutes in Japan .
METHODS	Adult patients with moyamoya disease who had experienced intracranial hemorrhage within the preceding year were given either conservative care or bilateral extracranial-intracranial direct bypass and were observed for 5 years .
METHODS	Primary and secondary end points were defined as all adverse events and rebleeding attacks , respectively .
RESULTS	Eighty patients were enrolled ( surgical , 42 ; nonsurgical , 38 ) .
RESULTS	Adverse events causing significant morbidity were observed in 6 patients in the surgical group ( 14.3 % ) and 13 patients in the nonsurgical group ( 34.2 % ) .
RESULTS	Kaplan-Meier survival analysis revealed significant differences between the 2 groups ( 3.2 % / y versus 8.2 % / y ; P = 0.048 ) .
RESULTS	The hazard ratio of the surgical group calculated by Cox regression analysis was 0.391 ( 95 % confidence interval , 0.148-1 .029 ) .
RESULTS	Rebleeding attacks were observed in 5 patients in the surgical group ( 11.9 % ) and 12 in the nonsurgical group ( 31.6 % ) , significantly different in the Kaplan-Meier survival analysis ( 2.7 % / y versus 7.6 % / y ; P = 0.042 ) .
RESULTS	The hazard ratio of the surgical group was 0.355 ( 95 % confidence interval , 0.125-1 .009 ) .
CONCLUSIONS	Although statistically marginal , Kaplan-Meier analysis revealed the significant difference between surgical and nonsurgical group , suggesting the preventive effect of direct bypass against rebleeding .
BACKGROUND	http://www.umin.ac.jp/ctr/index.htm .
BACKGROUND	Unique identifier : C000000166 .

###24438620
BACKGROUND	Previous studies demonstrated that vagus nerve stimulation ( VNS ) is an effective therapy for drug-resistant epilepsy .
BACKGROUND	Acupuncture is also used to treat epilepsy .
BACKGROUND	This study was designed to examine the safety and effectiveness of transcutaneous auricular vagus nerve stimulation ( ta-VNS ) for patients with drug-resistant epilepsy .
METHODS	A total of 50 volunteer patients with drug-resistant epilepsy were selected for a random clinical trial to observe the therapeutic effect of ta-VNS .
METHODS	The seizure frequency , quality of life , and severity were assessed in weeks 8 , 16 , and 24 of the treatment according to the percentage of seizure frequency reduction .
RESULTS	In the pilot study , 47 of the 50 epilepsy patients completed the 24-week treatment ; three dropped off .
RESULTS	After 8-week treatment , six of the 47 patients ( 12 % ) were seizure free and 12 ( 24 % ) had a reduction in seizure frequency .
RESULTS	In week 16 of the continuous treatment , six of the 47 patients ( 12 % ) were seizure free ; 17 ( 34 % ) had a reduction in seizure frequency .
RESULTS	After 24 weeks ' treatment , eight patients ( 16 % ) were seizure free ; 19 ( 38 % ) had reduced seizure frequency .
CONCLUSIONS	Similar to the therapeutic effect of VNS , ta-VNS can suppress epileptic seizures and is a safe , effective , economical , and widely applicable treatment option for drug-resistant epilepsy .
CONCLUSIONS	( ChiCTR-TRC-10001023 ) .

###25337976
BACKGROUND	Prior investigations have suggested that physician-related factors may contribute to differential use of TKA among women and ethnic minorities .
BACKGROUND	We sought to evaluate the effect of surgeon bias on recommendations for TKA .
OBJECTIVE	Using an experimental approach with standardized patient scenarios , we sought to evaluate surgeon recommendations regarding TKA , specifically to determine whether recommendations for TKA are influenced by ( 1 ) patient race , and ( 2 ) patient sex .
METHODS	We developed four computerized scenarios for all combinations of race ( white or black ) and sex ( male or female ) for otherwise similar patients with end-stage knee osteoarthritis .
METHODS	Patients gave an orthopaedic history of 2years worsening pain with decreased functional status and failure of oral antiinflammatory medications and corticosteroid intraarticular injections .
METHODS	Orthopaedic surgeons attending the 2012 annual meetings of the New York State Society of Orthopaedic Surgeons and American Association of Hip and Knee Surgeons were recruited for the study .
METHODS	Surgeons passing an open recruitment table at each meeting were asked to participate .
METHODS	Of the 1111 surgeons in attendance at either meeting , 113 ( 10.2 % ) participated in the study .
METHODS	All participants viewed the `` control '' patient 's story ( white male ) and were randomized to view one of the three `` experimental '' scenarios ( white female , black male , black female ) .
METHODS	After viewing each scenario , the participants were anonymously asked whether they would recommend TKA .
METHODS	An a priori power analysis showed that 112 participants were needed to detect a 15 % difference in the likelihood of recommending surgery for white versus nonwhite patients in the test scenarios evaluated with 90 % power at a level of significance of 0.05 .
RESULTS	Of the 39 surgeons who viewed the white male plus black female scenario , there were 33 ( 85 % ) concordant responses ( TKA offered to both patients ) and six discordant responses ( TKA offered to only one of the patients ) , with no effect of patient race and sex ( p = 0.99 ) .
RESULTS	Of the 37 surgeons who viewed the white male plus black male scenario , there were 33 ( 89 % ) concordant responses and four discordant responses , with no effect of patient race ( p = 0.32 ) .
RESULTS	Of the 37 surgeons who viewed the white male plus white female scenario , there were 30 ( 77 % ) concordant responses and seven discordant responses , with no effect of patient sex ( p = 0.71 ) .
CONCLUSIONS	After orthopaedic surgeons viewed video scenarios of patients with end-stage knee osteoarthritis , patient race and sex were not associated with a different likelihood of a surgical recommendation .
CONCLUSIONS	Our findings support the notion that patient race and sex may be less influential on decision making when there are strong clinical data to support a decision .
CONCLUSIONS	Physician bias may have a greater effect on decision making in situations where the indications for surgery are less clear .

###25740979
BACKGROUND	Metformin may improve metabolic factors ( insulin , glucose , leptin , highly sensitive C-reactive protein [ hs-CRP ] ) associated with poor breast cancer outcomes .
BACKGROUND	The NCIC Clinical Trials Group ( NCIC CTG ) MA .32 investigates effects of metformin vs placebo on invasive disease-free survival and other outcomes in early breast cancer .
BACKGROUND	Maintaining blinding of investigators to outcomes , we conducted a planned , Data Safety Monitoring Committee-approved , analysis of the effect of metformin vs placebo on weight and metabolic factors at six months , including examination of interactions with baseline body mass index ( BMI ) and insulin , in the first 492 patients with paired blood samples .
METHODS	Eligible nondiabetic subjects with T1-3 , N0-3 , M0 breast cancer who had completed surgery and ( neo ) adjuvant chemotherapy ( if given ) provided fasting plasma samples at random assignment and at six months .
METHODS	Glucose was measured locally ; blood was aliquoted , frozen , and stored at -80 C. Paired plasma aliquots were analyzed for insulin , hs-CRP , and leptin .
METHODS	Spearman correlation coefficients were calculated and comparisons analyzed using Wilcoxon signed rank test .
METHODS	All statistical tests were two-sided .
RESULTS	Mean age was 52.19.5 years in the metformin group and 52.6 9.8 years in the placebo group .
RESULTS	Arms were balanced for estrogen/progesterone receptor , BMI , prior ( neo ) adjuvant chemotherapy , and stage .
RESULTS	At six months , decreases in weight and blood variables were statistically significantly greater in the metformin arm ( vs placebo ) in univariate analyses : weight -3.0 % , glucose -3.8 % , insulin -11.1 % , homeostasis model assessment -17.1 % , leptin -20.2 % , hs-CRP -6.7 % ; all P values were less than or equal to .03 .
RESULTS	There was no statistically significant interaction of change in these variables with baseline BMI or insulin .
CONCLUSIONS	Metformin statistically significantly improved weight , insulin , glucose , leptin , and CRP at six months .
CONCLUSIONS	Effects did not vary by baseline BMI or fasting insulin .

###26521581
OBJECTIVE	To observe the efficacy of acupuncture on pain after replantation of severed finger .
METHODS	A total of 80 patients who underwent replantation of severed finger were randomly divided into an observation group and a control group , 40 cases in each one .
METHODS	The patients in the control group were treated with postoperative routine care of hand surgery , while patients in the observation group , based on the regular treatment , were treated with acupuncture within first 72 h of surgery .
METHODS	The health side of Yanglingquan ( GB 34 ) , Xuehai ( SP 10 ) , Hegu ( LI 4 ) , Houxi ( SI 3 ) were selected and the needles were retained for 30 min .
METHODS	The acupuncture was given for 6 times .
METHODS	The evaluation was performed by using visual analogue scale ( VAS ) 2 h , 4 h , 6 h , 12 h , 24 h , 48 h and 72 h after surgery .
METHODS	The use of analgesics after surgery was recorded in the two groups , and the blood supply and survival rate of severed finger were evaluated .
RESULTS	Compared between the two groups , the VAS 4 h , 6 h , 12 h , 24 h and 48 h after surgery in the observation group was lower than that in the control group ( all P < 0.05 ) ; the use frequency of analgesics in the observation group was lower than that in the control group ( P < 0.05 ) ; the abnormality rate of blood supply in the observation group was lower than that in the control group ( P < 0.05 ) .
CONCLUSIONS	Acupuncture can significantly relieve postoperative pain of replantation of severed finger , and reduce the occurrence rate of abnormal blood supply , which is worthy of clinical promotion .

###24283249
BACKGROUND	Back pain is a common and disabling condition for people in rural and remote areas .
BACKGROUND	In these areas , access to rehabilitation services is limited by service availability .
BACKGROUND	Telerehabilitation is suggested as a solution for providing physical therapy services ; however , the validity of clinical assessment is largely unproven .
BACKGROUND	The aim of this study was to establish the validity of clinically pragmatic remote assessment of spinal posture , active movements of the lumbar spine , and the passive straight leg raise ( SLR ) test .
METHODS	Face-to-face physical therapist assessment was compared with telerehabilitation assessment of spinal posture , active movements of the lumbar spine , and the SLR test .
METHODS	Twenty-six participants recruited from a rural population with current or recent low back pain ( LBP ) were assessed by a face-to-face physical therapist and a remote physical therapist .
METHODS	Pain , disability , and clinical measurements were assessed .
METHODS	Outcomes were compared to establish agreement .
RESULTS	High levels of agreement were found with detecting pain with specific lumbar movements , eliciting symptoms , and sensitizing the SLR test .
RESULTS	Moderate agreement occurred with identifying the worst lumbar spine movement direction , SLR range of motion , and active lumbar spine range of motion .
RESULTS	Poor agreement occurred with postural analysis and identifying reasons for limitations to lumbar movements .
CONCLUSIONS	Conducted in a rural clinical setting , this study validates elements of the physical assessment of the lumbar spine and identifies technical and clinical issues to be addressed by future research .
CONCLUSIONS	Important components of the standard musculoskeletal assessment of LBP are valid via telerehabilitation in a clinical setting .

###24853262
OBJECTIVE	To compare 2 lenticule insertion methods currently in use for Descemet stripping automated endothelial keratoplasty ( DSAEK ) .
METHODS	Prospective randomized single-masked study .
METHODS	Twenty patients with Fuchs endothelial dystrophy and pseudophakic bullous keratopathy undergoing DSAEK surgery were included and randomized to the use of either EndoGlide or EndoSerter as a delivery method for the donor lenticule .
METHODS	Post surgery , patients were monitored for up to 1 year .
METHODS	Evaluation included corrected distance visual acuity ( CDVA ) and refraction .
METHODS	Specular microscopy images were obtained at the 6 - and 12-month visits .
METHODS	Complications , including rebubbling rate , graft dislocation , and graft failure , were recorded .
RESULTS	Twenty eyes were randomized to receive the Tan EndoGlide or the EndoSerter injector for lenticule insertion .
RESULTS	Mean patient age was 65.98.4 years and 70.39.8 years in the Tan EndoGlide and EndoSerter groups , respectively ( P = .3 ) .
RESULTS	Two eyes in each group needed rebubbling .
RESULTS	The mean endothelial cell loss , including the rebubbled eyes , at the 12-month visit was 1093629 cells/mm2 ( range : 239-2109 cells/mm2 , mean percentage cell loss 41.2 % ) and 877566 cells/mm2 ( range : 116-1851 cells/mm2 , mean percentage cell loss 31.4 % ) in the Tan EndoGlide and EndoSerter groups , respectively ( P = .45 ) .
RESULTS	Mean CDVA did not show a statistically significant difference between the 2 groups at the 6 - or 12-month visit .
CONCLUSIONS	The EndoSerter shows comparable results to the Tan EndoGlide .
CONCLUSIONS	However , further investigation is warranted in order to validate these findings .

###25175658
BACKGROUND	Even in stable asthma patients , acinar ventilation distribution can be abnormal , and we aimed to specifically maximize its reversibility by switching patients from a standard inhaled corticosteroid ( iCS ) to a fine particle iCS formulation .
METHODS	For this prospective double-blind double-dummy randomized study , 66 stable asthma patients under maintenance iCS ( equivalent budesonide 800 g/day ) were screened for abnormal baseline acinar ventilation heterogeneity ( Sacin ) .
METHODS	After a 3-week run-in period , 35 eligible patients were randomized to fine particle beclomethasone ( HFA-BDP ; Qvar Autohaler ) or to budesonide ( DPI-BUD ; Pulmicort Turbohaler ) .
METHODS	Asthma Control Test ( ACT ) score and various lung function indices reflecting the small airways were obtained at baseline , after 6 and 12 weeks .
RESULTS	Thirty one patients [ age :52 17 ( SD ) years ; FEV1 :76 19 ( SD ) % pred ] completed the study ( DPI-BUD : n = 16 ; HFA-BDP : n = 15 ) .
RESULTS	After 6 and 12 weeks , there were no significant changes in acinar or conductive ventilation heterogeneity , nor in mid-expiratory flow , RV/TLC , closing capacity , impulse oscillometry indices ( resistance , reactance ) , bronchial NO production or alveolar NO , in either treatment arm .
RESULTS	Asthma control was maintained in both arms .
CONCLUSIONS	In stable asthma patients with small airways dysfunction under maintenance therapy , there is a residual functional abnormality in the lung periphery which is probably not eosinophilic in origin and can not be normalized with the iCS formulations under study .
CONCLUSIONS	ISRCTN17195095 .

###24280031
BACKGROUND	Biomedical treatment options for autism spectrum disorder ( ASD ) are extremely limited .
BACKGROUND	Repetitive transcranial magnetic stimulation ( rTMS ) is a safe and efficacious technique when targeting specific areas of cortical dysfunction in major depressive disorder , and a similar approach could yield therapeutic benefits in ASD , if applied to relevant cortical regions .
OBJECTIVE	The aim of this study was to examine whether deep rTMS to bilateral dorsomedial prefrontal cortex improves social relating in ASD .
METHODS	28 adults diagnosed with either autistic disorder ( high-functioning ) or Asperger 's disorder completed a prospective , double-blind , randomized , placebo-controlled design with 2 weeks of daily weekday treatment .
METHODS	This involved deep rTMS to bilateral dorsomedial prefrontal cortex ( 5 Hz , 10-s train duration , 20-s inter-train interval ) for 15 min ( 1500 pulses per session ) using a HAUT-Coil .
METHODS	The sham rTMS coil was encased in the same helmet of the active deep rTMS coil , but no effective field was delivered into the brain .
METHODS	Assessments were conducted before , after , and one month following treatment .
RESULTS	Participants in the active condition showed a near significant reduction in self-reported social relating symptoms from pre-treatment to one month follow-up , and a significant reduction in social relating symptoms ( relative to sham participants ) for both post-treatment assessments .
RESULTS	Those in the active condition also showed a reduction in self-oriented anxiety during difficult and emotional social situations from pre-treatment to one month follow-up .
RESULTS	There were no changes for those in the sham condition .
CONCLUSIONS	Deep rTMS to bilateral dorsomedial prefrontal cortex yielded a reduction in social relating impairment and socially-related anxiety .
CONCLUSIONS	Further research in this area should employ extended rTMS protocols that approximate those used in depression in an attempt to replicate and amplify the clinical response .

###24329187
OBJECTIVE	To elucidate the relationship between CYP2D6 genotype and risperidone pharmacokinetics and extrapyramidal symptoms we propose the APSEP pharmacogenetic clinical trial .
METHODS	Twenty-five healthy subjects were included in this randomized , placebo-controlled , single dose ( risperidone 2.5 mg ) crossover and double-blind clinical trial .
METHODS	Subjects were selected according to their CYP2D6 genotype and classified as : poor metabolizers ( n = 8 ) , extensive metabolizers ( n = 10 ) and ultrarapid metabolizers ( n = 7 ) .
CONCLUSIONS	Our study demonstrates that CYP2D6 predicted 65 % of the risperidone metabolism variability .
CONCLUSIONS	Moreover , its ability to predict actigraphy records is similar to the predictive power of pharmacokinetic parameters ( 24 % ) .
CONCLUSIONS	Our results also highlight the need for the development of pharmacogenetic predictors that take into account the complexity of pharmacokinetic and pharmacodynamic relationships .

###24989138
OBJECTIVE	Tedizolid phosphate is a novel antibacterial under investigation for the treatment of gram-positive infections .
OBJECTIVE	This study was conducted to assess the pharmacokinetics , safety , and tolerability of intravenous tedizolid phosphate as well as the oral bioavailability of tedizolid phosphate .
METHODS	Double-blind , single-ascending dose , multiple-dose pharmacokinetics study , as well as tolerability and open-label crossover studies .
METHODS	Single center in the United States ( Covance Clinical Research Unit , Madison , WI ) between September 2009 and January 2010 .
METHODS	Ninety healthy volunteers .
METHODS	Single intravenous ( IV ) doses of tedizolid phosphate 50 mg ( lead-in ) and 100-400 mg .
METHODS	Single oral and IV dose of tedizolid phosphate 200 mg in crossover fashion .
METHODS	Multiple IV doses of tedizolid phosphate 200 and 300 mg for up to 7 days .
RESULTS	A dose-dependent increase was observed in the maximum plasma concentration ( 1.2-5 .1 g/ml ) and the area under the concentration-time curve ( 17.4-58 .7 g hr/ml ) of tedizolid ( the microbiologically active moiety of tedizolid phosphate ) after single IV doses of tedizolid phosphate 100-400 mg .
RESULTS	Administration of IV tedizolid phosphate 200 mg once/day for 7 days resulted in minimal ( 28 % ) tedizolid accumulation .
RESULTS	The absolute oral bioavailability of tedizolid after a single 200-mg dose of tedizolid phosphate was 91 % ; pharmacokinetic parameters of tedizolid were similar with oral and IV administration .
RESULTS	Treatment-related adverse events occurred in 41 % of subjects .
RESULTS	Most adverse events were related to infusion site and became more frequent with multiple dosing .
RESULTS	In an additional 3-day tolerability study , IV tedizolid phosphate 200 mg and placebo were similarly tolerated , based on visual infusion phlebitis scores .
CONCLUSIONS	These results from a population of healthy volunteers support once/day dosing of tedizolid phosphate 200 mg with both the oral and IV formulations , without the need for dose adjustment when switching administration routes .

###24561548
OBJECTIVE	The risk of stroke in patients with atrial fibrillation ( AF ) increases with age .
OBJECTIVE	In the ARISTOTLE trial , apixaban when compared with warfarin reduced the rate of stroke , death , and bleeding .
OBJECTIVE	We evaluated these outcomes in relation to patient age .
RESULTS	A total of 18 201 patients with AF and a raised risk of stroke were randomized to warfarin or apixaban 5 mg b.d. with dose reduction to 2.5 mg b.d. or placebo in 831 patients with 2 of the following criteria : age 80 years , body weight 60 kg , or creatinine 133 mol/L .
RESULTS	We used Cox models to compare outcomes in relation to patient age during 1.8 years median follow-up .
RESULTS	Of the trial population , 30 % were < 65 years , 39 % were 65 to < 75 , and 31 % were 75 years .
RESULTS	The rates of stroke , all-cause death , and major bleeding were higher in the older age groups ( P < 0.001 for all ) .
RESULTS	Apixaban was more effective than warfarin in preventing stroke and reducing mortality across all age groups , and associated with less major bleeding , less total bleeding , and less intracranial haemorrhage regardless of age ( P interaction > 0.11 for all ) .
RESULTS	Results were also consistent for the 13 % of patients 80 years .
RESULTS	No significant interaction with apixaban dose was found with respect to treatment effect on major outcomes .
CONCLUSIONS	The benefits of apixaban vs. warfarin were consistent in patients with AF regardless of age .
CONCLUSIONS	Owing to the higher risk at older age , the absolute benefits of apixaban were greater in the elderly .

###25162028
OBJECTIVE	The 5-year clinical outcomes and prognostic factors of nasopharyngeal carcinoma ( NPC ) patients treated with intensity modulated radiotherapy ( IMRT ) were evaluated .
METHODS	Six hundred ninety five NPC patients primarily treated with IMRT in Sichuan Cancer Hospital from January , 2003 to December , 2006 were analyzed retrospectively , including 540 males and 155 females .
METHODS	The prescription dose was delivered as follows : gross target volume ( GTVnx ) 67-76 Gy in 30-33 fractions , positive neck lymph nodes ( GTVln-R/L ) 60-70 Gy in 30-33 fractions , high-risk clinical target volume ( CTV1 ) 60-66 Gy , low-risk clinical target volume ( CTV2 ) 54-60 Gy , and clinical target volume of cervical lymph node regions ( CTVln ) 50-55 Gy .
RESULTS	The 5-year local control ( LC ) , regional control , distant metastasis-free survival ( DMFS ) , disease free survival , disease specific survival , and overall survival ( OS ) rates were 89.8 % , 95.2 % , 74.1 % , 69.6 % , 83.2 % , and 77.1 % .
RESULTS	The 5-year DMFS of IMRT and IMRT combined with chemotherapy was 62.1 % and 70.9 % , the OS of them was 72.9 % and 79.1 % .
RESULTS	The incidence of grade 3 acute and late toxicity was 38.3 % and 4.2 % , respectively .
CONCLUSIONS	The 5-year LC and OS rate of NPC treated with IMRT was 89.8 % and 77.1 % .
CONCLUSIONS	The clinical stage , N stage , volume of GTVnx , and chemotherapy were the main prognostic factor for the OS .
CONCLUSIONS	Distant metastasis was the main pattern of failure .

###25647278
OBJECTIVE	Measure the impact of facial defect reconstruction on observer-graded attractiveness and negative facial perception .
METHODS	Prospective , randomized , controlled experiment .
METHODS	One hundred twenty casual observers viewed images of faces with defects of varying sizes and locations before and after reconstruction as well as normal comparison faces .
METHODS	Observers rated attractiveness , defect severity , and how disfiguring , bothersome , and important to repair they considered each face .
RESULTS	Facial defects decreased attractiveness -2.26 ( 95 % confidence interval [ CI ] : -2.45 , -2.08 ) on a 10-point scale .
RESULTS	Mixed effects linear regression showed this attractiveness penalty varied with defect size and location , with large and central defects generating the greatest penalty .
RESULTS	Reconstructive surgery increased attractiveness 1.33 ( 95 % CI : 1.18 , 1.47 ) , an improvement dependent upon size and location , restoring some defect categories to near normal ranges of attractiveness .
RESULTS	Iterated principal factor analysis indicated the disfiguring , important to repair , bothersome , and severity variables were highly correlated and measured a common domain ; thus , they were combined to create the disfigured , important to repair , bothersome , severity ( DIBS ) factor score , representing negative facial perception .
RESULTS	The DIBS regression showed defect faces have a 1.5 standard deviation increase in negative perception ( DIBS : 1.69 , 95 % CI : 1.61 , 1.77 ) compared to normal faces , which decreased by a similar magnitude after surgery ( DIBS : -1.44 , 95 % CI : -1.49 , -1.38 ) .
RESULTS	These findings varied with defect size and location .
CONCLUSIONS	Surgical reconstruction of facial defects increased attractiveness and decreased negative social facial perception , an impact that varied with defect size and location .
CONCLUSIONS	These new social perception data add to the evidence base demonstrating the value of high-quality reconstructive surgery .
METHODS	NA .

###24886536
BACKGROUND	The aim of the present study was to evaluate the effect of adjunctive chlorhexidine ( CHX ) mouthrinse on gingival crevicular fluid ( GCF ) MMP-8 and TIMP-1 levels in plaque-associated gingivitis .
METHODS	A total of 50 gingivitis patients were included in the present study .
METHODS	In addition to daily plaque control , CHX group rinsed with CHX , while placebo group rinsed with placebo mouthrinse for 4 weeks .
METHODS	GCF samples were collected , and clinical parameters including plaque index , papillary bleeding index , calculus index and pocket depth were recorded at baseline and 4 weeks .
METHODS	GCF MMP-8 and TIMP-1 levels were determined by immunofluorometric assay ( IFMA ) and enzyme-linked immunosorbent assay ( ELISA ) , respectively .
RESULTS	In both groups , GCF MMP-8 levels of anterior and posterior sites at four weeks were not different from baseline ( p > 0.05 ) .
RESULTS	There were no significant differences in GCF MMP-8 levels between the study groups at four weeks ( p > 0.05 ) .
RESULTS	GCF TIMP-1 levels of anterior and posterior sites at four weeks were higher compared to baseline in both groups ( p < 0.05 ) .
RESULTS	There was no significant difference in GCF TIMP level between the study groups at four weeks ( p > 0.05 ) .
CONCLUSIONS	CHX usage had no significant effects on the GCF MMP-8 and TIMP-1 levels in plaque-associate gingivitis .
CONCLUSIONS	However , daily plaque control resulted in the increase of GCF TIMP-1 levels regardless of CHX usage .

###25468682
BACKGROUND	Attentional resources appear to be involved in the occurrence of FoG .
BACKGROUND	The Parkgait study recently reported that methylphenidate reduces gait hypokinesia and freezing of gait ( FoG ) in advanced PD patients receiving STN-DBS in the off-dopaminergic drug condition .
BACKGROUND	Methylphenidate is considered to improve attention .
BACKGROUND	The primary objective of the present ancillary study was to determine whether methylphenidate reduced the interference between a cognitive task and gait in patients with FoG .
BACKGROUND	The study 's secondary objective was to compare attentional performance in methylphenidate-treated and placebo-treated patients .
METHODS	A total of 24 patients ( from two centers ) were included in the study .
METHODS	Patients were randomly assigned 1:1 to a three-month course of methylphenidate ( 1mg/kg/day ) or placebo .
METHODS	Patients were assessed after an acute L-dopa challenge .
METHODS	The primary outcome criterion was the stride length ratio ( ( dual-task stride length minus free gait stride length ) / free gait stride length ) .
METHODS	Trials with FoG episodes were excluded from the analysis .
METHODS	Secondary outcomes included changes in reaction times for computerized attention tasks and FoG severity .
RESULTS	When comparing patients receiving methylphenidate with those receiving placebo , we did not observe any significant differences in the interaction between the dual task and gait or in attentional performance .
CONCLUSIONS	As in the main Parkgait study , methylphenidate did not reduce gait hypokinesia in patients receiving dopaminergic treatment .
CONCLUSIONS	Our present results suggest that the reduction in the number of FoG episodes previously observed in patients on methylphenidate was neither due to interaction between a dual-task and gait nor an increase in attentional performance .

###25379625
BACKGROUND	Complementary and alternative medicine ( CAM ) use has been increasing and these unconventional therapies do have important adverse effects .
BACKGROUND	We evaluated predictors of CAM use among U.S. adults .
METHODS	We analyzed the 2007 Health Information National Trends Survey ( n = 7503 ) and used logistic regression models to evaluate the association of demographic , lifestyle characteristics and healthcare perceptions of respondents who used CAM within the previous 12 months ( n = 1980 ) versus those who did not ( n = 5523 ) .
METHODS	We used survey weights in all analyses and performed variance estimations using Taylor series linearization to account for the complex survey design .
RESULTS	Females ( odds ratio [ OR ] = 1.46 ; 95 % confidence interval [ CI ] : 1.15-1 .86 ) , college graduates ( OR = 1.61 ; 95 % CI : 1.24-2 .08 ) and those who considered the quality of their healthcare to be poor ( OR = 2.16 ; 95 % CI : 1.28-3 .65 ) were more likely to use CAM , whereas blacks ( OR = 0.58 ; 95 % CI : 0.39-0 .85 ) were less likely to use CAM .
RESULTS	Among CAM users , 47.6 % did not inform their doctors .
RESULTS	However , no factor predicted those who did not inform their doctors of their CAM use .
CONCLUSIONS	Many adults in the United States use CAM without informing their doctors .
CONCLUSIONS	Care providers should inquire about CAM usage from their patients , document them and counsel their patients regarding their use of these less regulated therapies .

###25441251
OBJECTIVE	Soy has been associated with lower risk of cardiovascular disease in Asian countries which consume daily soy .
OBJECTIVE	Our study examined whether production of equol , an estrogen metabolite , affected the ability of soy nuts to improve cardiovascular risk factors .
METHODS	Sixty postmenopausal women participated in a randomized , controlled , crossover trial of a Therapeutic Lifestyle Changes ( TLC ) diet alone and a TLC diet in which 0.5 cup of soy nuts ( 25 g of soy protein and 101 mg of aglycone isoflavones ) replaced 25 g of nonsoy protein daily .
METHODS	Each diet was followed for 8 weeks at the end of which blood pressure ( BP ) , lipid levels , adhesion molecules and inflammatory markers were measured .
RESULTS	Women with MetS had significantly higher baseline body mass index ( BMI ) , BP , triglycerides ( TG ) , and soluble intercellular adhesion molecule ( sICAM ) than women without MetS .
RESULTS	In women with MetS on the soy diet , significant reductions in diastolic BP ( 7.7 % ; P = 0.02 ) , TG ( 22.9 % ; P = 0.02 ) , C-reactive protein ( CRP ) ( 21.4 % ; P = 0.01 ) and sICAM ( 7.3 % ; P = 0.03 ) were noted among equol producers compared to levels on the TLC diet .
RESULTS	No significant changes were noted in equol nonproducers .
RESULTS	Similarly , in women without MetS , only equol producers had significant reductions in diastolic BP ( 3.3 % , P = 0.02 ) and CRP ( 30 % , P = 0.04 ) .
RESULTS	In contrast to women with MetS , TG and sICAM levels were not affected in women without MetS , a finding possibly related to lower baseline levels .
CONCLUSIONS	Cardiovascular risk reduction with soy nuts is not uniform and may be greater among producers of equol .

###25409100
OBJECTIVE	The goal of the study was to assess semantic priming to emotion and nonemotion cue words using a novel measure of associational breadth for participants who either took rapid eye movement ( REM ) or nonrapid eye movement ( NREM ) naps or who remained awake ; assess relation of priming to REM sleep consolidation and REM sleep inertia effects .
METHODS	The associational breadth task was applied in both a priming condition , where cue-words were signaled to be memorized prior to sleep ( primed ) , and a nonpriming condition , where cue words were not memorized ( nonprimed ) .
METHODS	Cue words were either emotional ( positive , negative ) or nonemotional .
METHODS	Participants were randomly assigned to either an awake ( WAKE ) or a sleep condition , which was subsequently split into NREM or REM groups depending on stage at awakening .
METHODS	Hospital-based sleep laboratory .
METHODS	Fifty-eight healthy participants ( 22 male ) ages 18 to 35 y ( Mage = 23.3 4.08 y ) .
RESULTS	The REM group scored higher than the NREM or WAKE groups on primed , but not nonprimed emotional cue words ; the effect was stronger for positive than for negative cue words .
RESULTS	However , REM time and percent correlated negatively with degree of emotional priming .
RESULTS	Priming occurred for REM awakenings but not for NREM awakenings , even when the latter sleep episodes contained some REM sleep .
CONCLUSIONS	Associational breadth may be selectively consolidated during REM sleep for stimuli that have been tagged as important for future memory retrieval .
CONCLUSIONS	That priming decreased with REM time and was higher only for REM sleep awakenings is consistent with two explanatory REM sleep processes : REM sleep consolidation serving emotional downregulation and REM sleep inertia .

###24984998
OBJECTIVE	There are several reports regarding the role of therapeutic diets for patients with non-alcoholic fatty liver disease ( NAFLD ) .
OBJECTIVE	Therefore , the aim of this study was to determine the effects of a low-calorie , low-carbohydrate soy-containing diet on lipid profiles , liver enzymes , and coagulating factors in patients with NAFLD .
METHODS	This was a randomized parallel clinical trial involving 45 patients with NAFLD .
METHODS	The participants consumed three kinds of diets for 8 wk .
METHODS	Patients were randomly assigned to consume a low-calorie diet ; a low-calorie , low-carbohydrate diet ; or a low-calorie , low-carbohydrate soy-containing diet .
METHODS	Measurements were done according to the standard method .
RESULTS	Changes in weight were not significantly different in the three groups .
RESULTS	The low-calorie , low-carbohydrate soy-containing diet could reduce alanine aminotransferase ( -15.2 12.1 versus -6.8 4.6 in the low-calorie , low-carbohydrate diet , and -6.4 4.4 IU/L in the low-calorie diet ; P = 0.02 ) and serum fibrinogen levels ( -49.1 60.1 versus -12.9 8.1 and -17.4 8.4 g/L , respectively ; P = 0.01 ) .
RESULTS	Reductions in aspartate aminotransferase were significantly higher in the low-calorie , low-carbohydrate soy-containing group .
RESULTS	Changes in lipid profiles did not differ significantly between the groups .
RESULTS	The soy-containing diet did reduce malondialdehyde more than the other diets ( P = 0.01 ) .
CONCLUSIONS	A low-calorie , low-carbohydrate soy-containing diet could have beneficial effects on liver enzymes , malondialdehyde , and serum fibrinogen levels in patients with NAFLD .

###25415807
BACKGROUND	Hyperkalemia ( serum potassium level , > 5.0 mmol per liter ) is associated with increased mortality among patients with heart failure , chronic kidney disease , or diabetes .
BACKGROUND	We investigated whether sodium zirconium cyclosilicate ( ZS-9 ) , a novel selective cation exchanger , could lower serum potassium levels in patients with hyperkalemia .
METHODS	In this multicenter , two-stage , double-blind , phase 3 trial , we randomly assigned 753 patients with hyperkalemia to receive either ZS-9 ( at a dose of 1.25 g , 2.5 g , 5 g , or 10 g ) or placebo three times daily for 48 hours .
METHODS	Patients with normokalemia ( serum potassium level , 3.5 to 4.9 mmol per liter ) at 48 hours were randomly assigned to receive either ZS-9 or placebo once daily on days 3 to 14 ( maintenance phase ) .
METHODS	The primary end point was the exponential rate of change in the mean serum potassium level at 48 hours .
RESULTS	At 48 hours , the mean serum potassium level had decreased from 5.3 mmol per liter at baseline to 4.9 mmol per liter in the group of patients who received 2.5 g of ZS-9 , 4.8 mmol per liter in the 5-g group , and 4.6 mmol per liter in the 10-g group , for mean reductions of 0.5 , 0.5 , and 0.7 mmol per liter , respectively ( P < 0.001 for all comparisons ) and to 5.1 mmol per liter in the 1.25-g group and the placebo group ( mean reduction , 0.3 mmol per liter ) .
RESULTS	In patients who received 5 g of ZS-9 and those who received 10 g of ZS-9 , serum potassium levels were maintained at 4.7 mmol per liter and 4.5 mmol per liter , respectively , during the maintenance phase , as compared with a level of more than 5.0 mmol per liter in the placebo group ( P < 0.01 for all comparisons ) .
RESULTS	Rates of adverse events were similar in the ZS-9 group and the placebo group ( 12.9 % and 10.8 % , respectively , in the initial phase ; 25.1 % and 24.5 % , respectively , in the maintenance phase ) .
RESULTS	Diarrhea was the most common complication in the two study groups .
CONCLUSIONS	Patients with hyperkalemia who received ZS-9 , as compared with those who received placebo , had a significant reduction in potassium levels at 48 hours , with normokalemia maintained during 12 days of maintenance therapy .
CONCLUSIONS	( Funded by ZS Pharma ; ClinicalTrials.gov number , NCT01737697 . )

###24843963
OBJECTIVE	To compare the difference in the clinical efficacy on benign prostatic hyperplasia ( BPH ) between the acupuncture-moxibustion therapy and the medication of Qianliekang tablets .
METHODS	One hundred and twenty-eight patients were randomized into an acupuncture-moxibustion group and a Qianliekang group , 64 cases in each one .
METHODS	In the acupuncture-moxibustion group , acupuncture was applied to Shenshu ( BL 23 ) , Pangguangshu ( BL 28 ) , Zhongji ( CV 3 ) , Guanyuan ( CV 4 ) and Shuidao ( ST 28 ) , and the warm moxibustion therapy with moxa stick was used at Shenshu ( BL 23 ) , Guanyuan ( CV 4 ) and Shenque ( CV 8 ) , once every day .
METHODS	In the Qianliekang group , Qianliekang tablets were prescribed for oral administration , 4 tablets each time , three times a day , for 3 months .
METHODS	The International Prostate Symptom Score ( I-PSS ) and the changes in residual urine ( Ru ) and maximal urine flow rate ( Qmax ) determined with the ultrasonic B test were compared before and after treatment in the two groups .
RESULTS	The results of I-PSS , Qmax and Ru were improved obviously after treatment as compared with those before treatment in the two groups ( all P < 0.05 ) .
RESULTS	The improvements in the acupuncture-moxibustion group were much more obvious than those in the Qianliekang group [ 8.62 + / - 2.18 vs 15.26 + / - 2.81 , ( 16.04 + / - 4.33 ) mL/s vs ( 12.47 + / - 2.13 ) mL/s , ( 10.43 + / - 2.14 ) mL vs ( 32.13 + / - 3.24 ) mL , all P < 0.01 ] .
RESULTS	The total effective rate was 89.1 % ( 57/64 ) in the acupuncture-moxibustion group , which was better than 68.7 % ( 44/64 ) in the Qianliekang group .
CONCLUSIONS	Acupuncture-moxibustion therapy achieves the significant efficacy on BPH , which is better than the oral administration of Qianliekang tablets .

###25348000
OBJECTIVE	CALGB 40302 sought to determine whether lapatinib would improve progression-free survival ( PFS ) among women with hormone receptor-positive metastatic breast cancer treated with fulvestrant .
METHODS	Eligible women had estrogen receptor-positive and/or progesterone receptor-positive tumors , regardless of human epidermal growth factor receptor 2 ( HER2 ) status , and prior aromatase inhibitor treatment .
METHODS	Patients received fulvestrant 500 mg intramuscularly on day 1 , followed by 250 mg on days 15 and 28 and every 4 weeks thereafter , and either lapatinib 1,500 mg or placebo daily .
METHODS	The study planned to accrue 324 patients and was powered for a 50 % improvement in PFS with lapatinib from 5 to 7.5 months .
RESULTS	At the third planned interim analysis , the futility boundary was crossed , and the data and safety monitoring board recommend study closure , having accrued 295 patients .
RESULTS	At the final analysis , there was no difference in PFS ( hazard ratio [ HR ] of placebo to lapatinib , 1.04 ; 95 % CI , 0.82 to 1.33 ; P = .37 ) ; median PFS was 4.7 months for fulvestrant plus lapatinib versus 3.8 months for fulvestrant plus placebo .
RESULTS	There was no difference in overall survival ( OS ) ( HR , 0.91 ; 95 % CI , 0.68 to 1.21 ; P = .25 ) .
RESULTS	For HER2-normal tumors , median PFS did not differ by treatment arm ( 4.1 v 3.8 months ) .
RESULTS	For HER2-positive tumors , lapatinib was associated with longer median PFS ( 5.9 v 3.3 months ) , but the differential treatment effect by HER2 status was not significant ( P = .53 ) .
RESULTS	The most frequent toxicities were diarrhea , fatigue , and rash associated with lapatinib .
CONCLUSIONS	Adding lapatinib to fulvestrant does not improve PFS or OS in advanced ER-positive breast cancer and is more toxic .

###24509626
OBJECTIVE	This study aimed to assess the impact of 3 heights of simulated altitude exposure on repeat-sprint performance in team-sport athletes .
METHODS	Ten trained male team-sport athletes completed 3 sets of repeated sprints ( 9 4 s ) on a nonmotorized treadmill at sea level and at simulated altitudes of 2000 , 3000 , and 4000 m. Participants completed 4 trials in a random order over 4 wk , with mean power output ( MPO ) , peak power output ( PPO ) , blood lactate concentration ( Bla ) , and oxygen saturation ( SaO2 ) recorded after each set .
RESULTS	Each increase in simulated altitude corresponded with a significant decrease in SaO2 .
RESULTS	Total work across all sets was highest at sea level and correspondingly lower at each successive altitude ( P < .05 ; sea level < 2000 m < 3000 m < 4000 m ) .
RESULTS	In the first set , MPO was reduced only at 4000 m , but for subsequent sets , decreases in MPO were observed at all altitudes ( P < .05 ; 2000 m < 3000 m < 4000 m ) .
RESULTS	PPO was maintained in all sets except for set 3 at 4000 m ( P < .05 ; vs sea level and 2000 m ) .
RESULTS	BLa levels were highest at 4000 m and significantly greater ( P < .05 ) than at sea level after all sets .
CONCLUSIONS	These results suggest that `` higher may not be better , '' as a simulated altitude of 4000 m may potentially blunt absolute training quality .
CONCLUSIONS	Therefore , it is recommended that a moderate simulated altitude ( 2000-3000 m ) be employed when implementing intermittent hypoxic repeat-sprint training for team-sport athletes .

###25185469
OBJECTIVE	This study evaluates whether video-based coaching can enhance laparoscopic surgical skills performance .
BACKGROUND	Many professions utilize coaching to improve performance .
BACKGROUND	The sports industry employs video analysis to maximize improvement from every performance .
METHODS	Laparoscopic novices were baseline tested and then trained on a validated virtual reality ( VR ) laparoscopic cholecystectomy ( LC ) curriculum .
METHODS	After competence , subjects were randomized on a 1:1 ratio and each performed 5 VRLCs .
METHODS	After each LC , intervention group subjects received video-based coaching by a surgeon , utilizing an adaptation of the GROW ( Goals , Reality , Options , Wrap-up ) coaching model .
METHODS	Control subjects viewed online surgical lectures .
METHODS	All subjects then performed 2 porcine LCs .
METHODS	Performance was assessed by blinded video review using validated global rating scales .
RESULTS	Twenty subjects were recruited .
RESULTS	No significant differences were observed between groups in baseline performance and in VRLC1 .
RESULTS	For each subsequent repetition , intervention subjects significantly outperformed controls on all global rating scales .
RESULTS	Interventions outperformed controls in porcine LC1 [ Global Operative Assessment of Laparoscopic Skills : ( 20.5 vs 15.5 ; P = 0.011 ) , Objective Structured Assessment of Technical Skills : ( 21.5 vs 14.5 ; P = 0.001 ) , and Operative Performance Rating System : ( 26 vs 19.5 ; P = 0.001 ) ] and porcine LC2 [ Global Operative Assessment of Laparoscopic Skills : ( 28 vs 17.5 ; P = 0.005 ) , Objective Structured Assessment of Technical Skills : ( 30 vs 16.5 ; P < 0.001 ) , and Operative Performance Rating System : ( 36 vs 21 ; P = 0.004 ) ] .
RESULTS	Intervention subjects took significantly longer than controls in porcine LC1 ( 2920 vs 2004 seconds ; P = 0.009 ) and LC2 ( 2297 vs 1683 ; P = 0.003 ) .
CONCLUSIONS	Despite equivalent exposure to practical laparoscopic skills training , video-based coaching enhanced the quality of laparoscopic surgical performance on both VR and porcine LCs , although at the expense of increased time .
CONCLUSIONS	Video-based coaching is a feasible method of maximizing performance enhancement from every clinical exposure .

###24810871
OBJECTIVE	Metacognitive therapy ( MCT ) is one of the newer developments within cognitive therapy .
OBJECTIVE	This randomized controlled pilot study compared independently applied MCT with cognitive behavioural therapy ( CBT ) in outpatients with depression to explore the relative speed and efficacy of MCT , ahead of a planned randomized controlled trial .
METHODS	A total of 48 participants referred for outpatient therapy were randomized to up to 12 weeks of MCT or CBT .
METHODS	Key outcomes were reduction in depressive symptoms at week 4 and week 12 , measured using the independent-clinician-rated Quick Inventory of Depressive Symptomatology16 .
METHODS	Intention-to-treat and completer analyses as well as additional methods of reporting outcome of depression are presented .
RESULTS	Both therapies were effective in producing clinically significant change in depressive symptoms , with moderate-to-large effect sizes obtained .
RESULTS	No differences were detected between therapies in overall outcome or early change on clinician-rated or self-reported measures .
RESULTS	Post-hoc analyses suggest that MCT may have been adversely affected by greater comorbidity .
CONCLUSIONS	In this large pilot study conducted independently of MCT 's developers , MCT was an effective treatment for outpatients with depression , with similar results overall to CBT .
CONCLUSIONS	Insufficient power and imbalanced comorbidity limit conclusions regarding comparative efficacy so further studies of MCT and CBT are required .

###25281223
BACKGROUND	The drug 3,4-methylenedioxymethamphetamine ( MDMA , `` ecstasy , '' `` molly '' ) is thought to produce prosocial effects and enhance social interaction .
BACKGROUND	However , in most laboratory studies to date , the participants have been tested under nonsocial conditions , which may not simulate the effects the drug produces in more naturalistic social settings .
METHODS	Healthy experienced MDMA users participated in three laboratory sessions in which they received MDMA ( 0.5 or 1.0 mg/kg or placebo , double blind ) .
METHODS	They were randomly assigned to one of three social conditions , in which they were tested alone ( solitary ( SOL ) ; N = 10 ) , in the presence of a research assistant ( research assistant present ( RAP ) ; N = 11 ) or in the presence of another participant who also received the drug ( other participant present ( OPP ) ; N = 11 ) .
RESULTS	As expected , MDMA increased heart rate and blood pressure and produced positive subjective effects in all the three groups .
RESULTS	It also increased ratings of attractiveness of another person and increased social interaction in RAP and OPP .
RESULTS	The social context affected certain responses to the drug .
RESULTS	The effects of MDMA were greater in the OPP condition , compared to the SOL or RAP conditions , on measures of `` feel drug , '' `` dizzy , '' and on cardiovascular .
RESULTS	But responses to the drug on other measures , including social behavior , did not differ across the conditions .
CONCLUSIONS	These findings provide some support for the idea that drugs produce greater effects when they are used in the presence of other drug users .
CONCLUSIONS	However , the influence of the social context was modest , and it remains to be determined whether other variables related to social context would substantially alter the effects of MDMA or other drugs .

###24343191
OBJECTIVE	Parenting programs based on cognitive-behavioral and social learning principles are effective in changing child behavior problems and parenting styles .
OBJECTIVE	However , such programs typically have limited population reach .
OBJECTIVE	The current study aimed to evaluate the efficacy of a brief radio series that provided parenting advice based on the Triple P-Positive Parenting Program .
METHODS	One hundred thirty-nine parents of children aged 2 to 10 years who had concerns about their child 's behavioral and/or emotional adjustment were recruited , randomly assigned to either an intervention or waitlist control group , and completed online self-report measures .
METHODS	Parents in the intervention group were given access to seven Triple P podcasts online over a period of 2 weeks .
RESULTS	Parents in the intervention group improved significantly more than parents in the control group , from pre - to postintervention , on measures of child behavioral problems and parenting style , self-efficacy , and confidence .
RESULTS	These short-term intervention effects were maintained at the 6-month follow-up .
CONCLUSIONS	These results suggest that brief radio and online parenting programs can be effective and have the potential to reach a large proportion of parents experiencing child behavior problems .
CONCLUSIONS	Limitations , clinical significance , and future research suggestions are discussed .

###26255511
OBJECTIVE	To observe the efficacy of preventing constipation by electroacupuncture intervention in ischemic stroke patients at acute stage .
METHODS	Three hundred and forty ischemic stroke patients who matched the inclusive criteria were randomly divided into an electroacupuncture ( EA ) group and a routine treatment group , 170 cases in each one .
METHODS	In the EA group , based on routine western treatment , rehabilitation training and common acupuncture , Tianshu ( ST 25 ) and Zusanli ( ST 36 ) were selected and connected to SDZ-V Hwato brand electric acupuncture apparatus respectively , given stimulation of dense-disperse wave ( 10 Hz/50 Hz ) with electric current of 0.1 to 1.0 mA , once every day and 5 times a week in the first 2 weeks , 2 times a week in the latter 2 weeks .
METHODS	In the routine treatment group , only basic treatment was applied .
METHODS	In the two groups , the course of treatment was 4 weeks and 8 weeks ' follow-up was required after treatment .
METHODS	The actual numbers who independently defecated less than 3 times a week after 1 to 4 weeks ' treatment and in the 4th and the 8th weeks ' follow-up and condition taking laxative medicines during the 12 weeks in the two groups were observed and compared .
RESULTS	Compared on the numbers of constipation cases after 1 to 4 weeks ' treatment , those in the EA group were all less than those in the routine treatment group [ 24.7 % ( 42/170 ) vs. 36.5 % ( 62/170 ) , 18.8 % ( 32/170 ) vs. 30.6 % ( 52/170 ) , 10.5 % ( 17/162 ) vs. 27.5 % ( 44/160 ) , 9.3 % ( 15/162 ) vs. 19.4 % ( 31/160 ) , P < 0.05 , P < 0.001 ] .
RESULTS	In the 4th and the 8th weeks ' follow-up , numbers in the EA group were still less than those in the routine treatment group [ 9.0 % ( 14/156 ) vs. 18.1 % ( 28/155 ) , 7.7 % ( 12/155 ) vs. 16.9 ( 26/154 ) both P < 0.05 ) ] .
RESULTS	During the 12 weeks , the number of cases who took laxative medicines in the EA group was less than that in the routine treatment group [ 21.2 % ( 36/170 ) vs. 34.7 % ( 59/170 ) , P < 0.05 ] .
CONCLUSIONS	There is clinical significance to electroacupuncture at Tian-shui ( ST 25 ) and Zusanli ( ST 36 ) coibined with basic comprehensive treatment for preventing and treating constipation symptom in ischemic stroke acute stage .

###25225746
BACKGROUND	To date , there are no known methods for preventing acute kidney injury after cardiac surgery .
BACKGROUND	Increasing evidence suggests that erythropoietin has renal antiapoptotic and tissue protective effects .
BACKGROUND	However , recent human studies have shown conflicting results .
BACKGROUND	The authors aimed to study the effect of a single high-dose erythropoietin preoperatively on renal function after coronary artery bypass grafting in patients with preoperative impaired renal function .
METHODS	This single-center , randomized , double-blind , placebo-controlled study included 75 patients scheduled for coronary artery bypass grafting with preexisting renal impairment estimated glomerular filtration rate based on p-cystatin C ( < 60 and > 15 ml/min ) .
METHODS	The patients either received a single high-dose erythropoietin ( 400 IU/kg ) or placebo preoperatively .
METHODS	The primary endpoint was renal protection evaluated by p-cystatin C at the third postoperative day compared to the preoperative values .
METHODS	Incidence of acute kidney injury and other renal biomarker changes were among secondary endpoints .
RESULTS	There was no statistically significant difference on the third postoperative day for relative p-cystatin C level changes from baseline between the groups , 131 31 % ( mean SD ) for the study group and 125 24 % for the control group ( P = 0.31 ; 95 % CI , -0.6 to 20 % for the difference ) .
RESULTS	There were no statistically significant differences in other renal biomarkers or measures between the groups ( p-neutrophil gelatinase-associated lipocalin , p-creatinine , p-urea , and estimated glomerular filtration rate ) .
RESULTS	There were no other differences in outcome variables between the groups .
CONCLUSIONS	Intravenous administration of a single high-dose ( 400 IU/kg ) erythropoietin did not have a renal protective effect on patients with reduced kidney function undergoing coronary artery bypass surgery .

###24758374
BACKGROUND	Whether gender differences exist in procedure-related adverse events following cardiac resynchronization therapy ( CRT-D ) implantation is unknown .
BACKGROUND	We investigated the type and frequency of procedure-related adverse events among those enrolled in MADIT-CRT and identified clinical predictors for gender-specific events .
METHODS	We compared differences in the rate of procedure-related adverse events by gender ( 444 females and 1,346 males ) that occurred 30 days after the index procedure in the implantable cardioverter defibrillator ( ICD ) and CRT-D groups .
METHODS	Eight types of major adverse events were identified , defined as procedure-related complications deemed potentially life-threatening .
METHODS	Best subset regression analysis ( P < 0.10 ) was performed to identify baseline clinical factors associated with procedure-related adverse events that differed by gender .
RESULTS	Women randomized to CRT-D received a greater reduction in the risk of heart failure or death versus men ( P < 0.001 ) .
RESULTS	Women were twice as likely as men to experience a major procedure-related adverse event ( 6.3 % vs. 2.7 % ; P < 0.001 ) , including pneumothorax/hemothorax ( 3 % vs. 1 % ; P < 0.001 ) .
RESULTS	Women were more likely to experience a major adverse event related to CRT-D than ICD implantation ( 7.7 % vs. 2.9 % ; P = 0.018 ) .
RESULTS	Clinical predictors of major adverse events in females were smaller body mass index ( BMI ) , elevated blood urea nitrogen , and elevated creatinine .
RESULTS	The main predictor for pneumothorax/hemothorax was reduced BMI for women and men .
CONCLUSIONS	Women demonstrate greater clinical benefit from CRT than men but are more likely to experience adverse procedure-related events within the first 30 days after device implantation .
CONCLUSIONS	A smaller BMI seems to be a major factor associated with pneumothorax/hemothorax in both females and males .

###24521108
BACKGROUND	Dopaminergic medications relieve symptoms of the restless legs syndrome ( RLS ) but have the potential to cause iatrogenic worsening ( augmentation ) of RLS with long-term treatment .
BACKGROUND	Pregabalin may be an effective alternative .
METHODS	In this 52-week , randomized , double-blind trial , we assessed efficacy and augmentation in patients with RLS who were treated with pregabalin as compared with placebo and pramipexole .
METHODS	Patients were randomly assigned to receive 52 weeks of treatment with pregabalin at a dose of 300 mg per day or pramipexole at a dose of 0.25 mg or 0.5 mg per day or 12 weeks of placebo followed by 40 weeks of randomly assigned active treatment .
METHODS	The primary analyses involved a comparison of pregabalin and placebo over a period of 12 weeks with use of the International RLS ( IRLS ) Study Group Rating Scale ( on which the score ranges from 0 to 40 , with a higher score indicating more severe symptoms ) , the Clinical Global Impression of Improvement scale ( which was used to assess the proportion of patients with symptoms that were `` very much improved '' or `` much improved '' ) , and a comparison of rates of augmentation with pregabalin and pramipexole over a period of 40 or 52 weeks of treatment .
RESULTS	A total of 719 participants received daily treatment , 182 with 300 mg of pregabalin , 178 with 0.25 mg of pramipexole , 180 with 0.5 mg of pramipexole , and 179 with placebo .
RESULTS	Over a period of 12 weeks , the improvement ( reduction ) in mean scores on the IRLS scale was greater , by 4.5 points , among participants receiving pregabalin than among those receiving placebo ( P < 0.001 ) , and the proportion of patients with symptoms that were very much improved or much improved was also greater with pregabalin than with placebo ( 71.4 % vs. 46.8 % , P < 0.001 ) .
RESULTS	The rate of augmentation over a period of 40 or 52 weeks was significantly lower with pregabalin than with pramipexole at a dose of 0.5 mg ( 2.1 % vs. 7.7 % , P = 0.001 ) but not at a dose of 0.25 mg ( 2.1 % vs. 5.3 % , P = 0.08 ) .
RESULTS	There were six cases of suicidal ideation in the group receiving pregabalin , three in the group receiving 0.25 mg of pramipexole , and two in the group receiving 0.5 mg of pramipexole .
CONCLUSIONS	Pregabalin provided significantly improved treatment outcomes as compared with placebo , and augmentation rates were significantly lower with pregabalin than with 0.5 mg of pramipexole .
CONCLUSIONS	( Funded by Pfizer ; ClinicalTrials.gov number , NCT00806026 . )

###25157929
BACKGROUND	Poor sanitation is thought to be a major cause of enteric infections among young children .
BACKGROUND	However , there are no previously published randomized trials to measure the health impacts of large-scale sanitation programs .
BACKGROUND	India 's Total Sanitation Campaign ( TSC ) is one such program that seeks to end the practice of open defecation by changing social norms and behaviors , and providing technical support and financial subsidies .
BACKGROUND	The objective of this study was to measure the effect of the TSC implemented with capacity building support from the World Bank 's Water and Sanitation Program in Madhya Pradesh on availability of individual household latrines ( IHLs ) , defecation behaviors , and child health ( diarrhea , highly credible gastrointestinal illness [ HCGI ] , parasitic infections , anemia , growth ) .
RESULTS	We conducted a cluster-randomized , controlled trial in 80 rural villages .
RESULTS	Field staff collected baseline measures of sanitation conditions , behaviors , and child health ( May-July 2009 ) , and revisited households 21 months later ( February-April 2011 ) after the program was delivered .
RESULTS	The study enrolled a random sample of 5,209 children < 5 years old from 3,039 households that had at least one child < 24 months at the beginning of the study .
RESULTS	A random subsample of 1,150 children < 24 months at enrollment were tested for soil transmitted helminth and protozoan infections in stool .
RESULTS	The randomization successfully balanced intervention and control groups , and we estimated differences between groups in an intention to treat analysis .
RESULTS	The intervention increased percentage of households in a village with improved sanitation facilities as defined by the WHO/UNICEF Joint Monitoring Programme by an average of 19 % ( 95 % CI for difference : 12 % -26 % ; group means : 22 % control versus 41 % intervention ) , decreased open defecation among adults by an average of 10 % ( 95 % CI for difference : 4 % -15 % ; group means : 73 % intervention versus 84 % control ) .
RESULTS	However , the intervention did not improve child health measured in terms of multiple health outcomes ( diarrhea , HCGI , helminth infections , anemia , growth ) .
RESULTS	Limitations of the study included a relatively short follow-up period following implementation , evidence for contamination in ten of the 40 control villages , and bias possible in self-reported outcomes for diarrhea , HCGI , and open defecation behaviors .
CONCLUSIONS	The intervention led to modest increases in availability of IHLs and even more modest reductions in open defecation .
CONCLUSIONS	These improvements were insufficient to improve child health outcomes ( diarrhea , HCGI , parasite infection , anemia , growth ) .
CONCLUSIONS	The results underscore the difficulty of achieving adequately large improvements in sanitation levels to deliver expected health benefits within large-scale rural sanitation programs .
BACKGROUND	ClinicalTrials.gov NCT01465204 .
BACKGROUND	Please see later in the article for the Editors ' Summary .

###24851997
BACKGROUND	Neonatal thrombocytopenia is a common and important clinical problem in preterm neonates .
BACKGROUND	A trial assessing clinically relevant outcomes in relation to the different platelet count thresholds used to trigger transfusion has never been undertaken in preterm neonates with severe thrombocytopenia .
OBJECTIVE	Platelets for Neonatal Transfusion - Study 2 ( PlaNeT-2 ) aims to assess whether a higher prophylactic platelet transfusion threshold is superior to the lower thresholds in current standard practice in reducing the proportion of patients who have a major bleed or die up to study day 28 .
METHODS	PlaNeT-2 is a two-stage , randomised , parallel-group , superiority trial .
METHODS	PlaNet-2 compares clinical outcomes in preterm neonates ( < 34 weeks ' gestation at birth ) randomised to receive prophylactic platelet transfusions to maintain platelet counts at or above either 25 10 ( 9 ) / l or 50 10 ( 9 ) / l.
METHODS	The primary outcome measure is the proportion of patients who either die or experience a major bleed up to and including study day 28 .
METHODS	A total of 660 infants will be randomised .
CONCLUSIONS	This trial will help define optimal platelet transfusion support for severely thrombocytopenic preterm neonates by evaluating the risks and benefits of two different prophylactic neonatal platelet transfusion thresholds .

###25644344
BACKGROUND	Higher dietary energy as protein during weight loss results in a greater loss of fat mass and retention of muscle mass ; however , the impact of protein quality on the rates of myofibrillar protein synthesis ( MPS ) and lipolysis , processes that are important in the maintenance of muscle and loss of fat , respectively , are unknown .
OBJECTIVE	We aimed to determine how the consumption of different sources of proteins ( soy or whey ) during a controlled short-term ( 14-d ) hypoenergetic diet affected MPS and lipolysis .
METHODS	Men ( n = 19 ) and women ( n = 21 ) ( age 35-65 y ; body mass index 28-50 kg/m ( 2 ) ) completed a 14-d controlled hypoenergetic diet ( -750 kcal/d ) .
METHODS	Participants were randomly assigned , double blind , to receive twice-daily supplements of isolated whey ( 27 g/supplement ) or soy ( 26 g/supplement ) , providing a total protein intake of 1.3 0.1 g / ( kg d ) , or isoenergetic carbohydrate ( 25 g maltodextrin/supplement ) resulting in a total protein intake of 0.7 0.1 g / ( kg d ) .
METHODS	Before and after the dietary intervention , primed continuous infusions of L - [ ring - ( 13 ) C6 ] phenylalanine and [ ( 2 ) H5 ] - glycerol were used to measure postabsorptive and postprandial rates of MPS and lipolysis .
RESULTS	Preintervention , MPS was stimulated more ( P < 0.05 ) with ingestion of whey than with soy or carbohydrate .
RESULTS	Postintervention , postabsorptive MPS decreased similarly in all groups ( all P < 0.05 ) .
RESULTS	Postprandial MPS was reduced by 9 1 % in the whey group , which was less ( P < 0.05 ) than the reduction in soy and carbohydrate groups ( 28 5 % and 31 5 % , respectively ; both P < 0.05 ) after the intervention .
RESULTS	Lipolysis was suppressed during the postprandial period ( P < 0.05 ) , but more so with ingestion of carbohydrate ( P < 0.05 ) than soy or whey .
CONCLUSIONS	We conclude that whey protein supplementation attenuated the decline in postprandial rates of MPS after weight loss , which may be of importance in the preservation of lean mass during longer-term weight loss interventions .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01530646 .

###25522919
BACKGROUND	We conducted a randomized , double-blind , placebo-controlled trial to evaluate the effect of ultrasound-guided corticosteroid injection in patients with ulnar neuropathy at the elbow ( UNE ) .
METHODS	Fifty-five patients were randomized between an ultrasound-guided injection of 1 ml containing 40 mg methylprednisolone acetate and 10 mg lidocaine hydrochloride or a placebo injection .
METHODS	The primary outcome was the subjective change of symptoms after 3 months .
METHODS	The secondary outcomes were change in electrodiagnostic studies and ultrasonography findings .
RESULTS	A success rate of 30 % was found in the corticosteroid injection group versus 28 % in the placebo injection group .
RESULTS	Only the nerve cross-sectional area changed significantly in the intervention group , from a mean of 11.9 mm ( 2 ) to 10.9 mm ( 2 ) .
CONCLUSIONS	We could not demonstrate a positive effect of ultrasound-guided corticosteroid injection in UNE compared with placebo .
CONCLUSIONS	Favorable outcomes may be attributed to the natural course of UNE or the effect of patient education .

###25138182
OBJECTIVE	Little is known about the respective healing responses and clinical efficacy and safety of drug-eluting balloons ( DEB ) and the second generation of drug-eluting stents ( DES ) when used to treat in-stent restenosis ( ISR ) .
OBJECTIVE	In this study , we set out to compare prospectively the healing characteristics , as assessed by optical coherence tomography ( OCT ) , of DEB versus DES after treatment of ISR in bare metal stents ( BMS ) .
RESULTS	Fifty patients with BMS ISR were randomised to treatment with a paclitaxel-eluting balloon vs. an everolimus-eluting stent ( EES ) .
RESULTS	The primary endpoint was the percentage of uncovered struts , assessed with OCT at nine months , as a marker of vessel wall healing .
RESULTS	A mean of 366135 and 636184 struts were analysed per patient in the DEB and EES groups , respectively .
RESULTS	The percentage of uncovered struts per patient was significantly lower with DEB vs. EES ( 1.4 % vs. 3.1 % , p = 0.025 ) .
RESULTS	Mean neointimal hyperplasia area was 2.41.08 mm in DEB vs. 1.920.67 mm in EES ( p = 0.1806 ) , while the percentage of malapposed struts per patient was very low in both groups ( 0.2 % vs. 0.3 % , p = 0.699 ) .
RESULTS	At nine months , angiographic in-stent MLD ( minimum lumen diameter ) was lower ( 2.13 vs. 2.54 mm , p = 0.006 ) , while diameter stenosis ( 26.4 vs. 11.4 % , p = 0.002 ) , and LLL ( 0.28 vs. 0.07 mm , p = 0.1 ) were higher after DEB compared to EES .
RESULTS	During one-year follow-up , we did not observe differences in the rates of death , TLR ( target lesion revascularisation ) or stent thrombosis .
CONCLUSIONS	DEB appears to be associated with better healing characteristics , as assessed by stent strut coverage with OCT , but tended to be slightly less effective compared to EES .
CONCLUSIONS	These findings give support to the use of either DEB or EES as valuable treatment options for ISR .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT 01065532 .

###24320907
BACKGROUND	The aim of this study was to assess if the consumption of 3g of a commercially available L-arginine dietary supplement causes a postabsorptive rise in urea concentration or pH of unstimulated saliva in a group of physically active individuals .
METHODS	Salivary urea and pH were determined for 117 participants in a randomized double-blinded placebo-controlled study .
METHODS	Samples were collected by ` spitting ' method in fasting conditions .
METHODS	One hour prior to their second visit , participants consumed three tablets of L-arginine or placebo .
RESULTS	Urea concentration was significantly lower at second measurement for both the study and control group .
RESULTS	The magnitude of the change was not significant between the groups .
RESULTS	pH was higher for both groups at second measurement , but only significant for the study group .
RESULTS	The magnitude of the change was significant between the groups .
RESULTS	Participants who intermittently ingested protein dietary supplements and those with a Body Mass Index ( BMI ) higher than 25 had significantly higher basal urea concentration .
CONCLUSIONS	The results of this study did not confirm the hypothesis .
CONCLUSIONS	Further studies are needed to determine the effects of different doses of L-arginine supplements on the biochemical composition of saliva and the influence of their long-term consumption on the risk of developing dental diseases .

###24294977
BACKGROUND	Several studies suggest that a healthy diet with high emphasis on nutritious , low-energy components such as fruits , vegetables , and seafood tends to be more costly for consumers .
BACKGROUND	Derived from the ideas from the New Nordic Cuisine -- and inspired by the Mediterranean diet , the New Nordic Diet ( NND ) has been developed as a palatable , healthy and sustainable diet based on products from the Nordic region .
BACKGROUND	The objective of the study is to investigate economic consequences for the consumers of the NND , compared with an Average Danish Diet ( ADD ) .
METHODS	Combine quantity data from a randomized controlled ad libitum dietary 6 month intervention for central obese adults ( 18-65 years ) and market retail price data of the products consumed in the intervention .
METHODS	Adjust consumed quantities to market price incentives using econometrically estimated price elasticities .
RESULTS	Average daily food expenditure of the ADD as represented in the unadjusted intervention ( ADD-i ) amounted to 36.02 DKK for the participants .
RESULTS	The daily food expenditure in the unadjusted New Nordic Diet ( NND-i ) costs 44.80 DKK per day per head , and is hence about 25 % more expensive than the Average Danish Diet ( or about 17 % when adjusting for energy content of the diet ) .
RESULTS	Adjusting for price incentives in a real market setting , the estimated cost of the Average Danish Diet is reduced by 2.50 DKK ( ADD-m ) , compared to the unadjusted ADD-i diet , whereas the adjusted cost of the New Nordic Diet ( NND-m ) is reduced by about 3.50 DKK , compared to the unadjusted NND-i .
RESULTS	The distribution of food cost is however much more heterogeneous among consumers within the NND than within the ADD .
CONCLUSIONS	On average , the New Nordic Diet is 24-25 per cent more expensive than an Average Danish Diet at the current market prices in Denmark ( and 16-17 per cent , when adjusting for energy content ) .
CONCLUSIONS	The relatively large heterogeneity in food costs in the NND suggests that it is possible to compose an NND where the cost exceeds that of ADD by less than the 24-25 per cent .

###26131612
OBJECTIVE	To investigate the effectiveness of a 6-month Liuzijue qigong ( LQG ) program in promoting physical and psychosocial function in individuals with chronic obstructive pulmonary disease ( COPD ) .
METHODS	Single-blind , randomized controlled trial .
METHODS	Seven hospital respiratory care centers in Beijing .
METHODS	Individuals with COPD ( N = 126 ; mean age 71.1 2.7 , range 65-85 ) .
METHODS	Participants were randomly assigned to one of two groups : LQG ( n = 63 ) and control ( n = 63 ) .
METHODS	Subjects in the LQG group received a LQG program consisting of four 45-minute sessions each week and daily walking for 30 minutes for 6 months .
METHODS	Control subjects walked daily for 30 minutes .
METHODS	Data collection was performed at baseline , at 6 weeks , and at 6 months .
METHODS	Primary outcomes involved functional capacity , and secondary outcomes involved quality of life .
RESULTS	The LQG group had greater improvements in the 6-minute walk test ( P = .02 ) ; specific airway conductance ( P = .02 ) ; monitored functional task evaluation ( P = .04 ) ; Medical Outcomes Study 36-item Short-Form Health Survey ( SF-36 ; general health ( P < .001 ) , mental health ( P = .03 ) ) ; Chronic Respiratory Questionnaire ( dyspnea ( P = .05 ) , emotion ( P = .05 ) , and mastery ( P = .04 ) at 6-month follow-up .
RESULTS	After 6 months , the control group had significant improvement only on the SF-36 mental health ( P = .02 ) .
CONCLUSIONS	LQG promoted functional capacity and quality of life in older adults with COPD at 6 months and is a good alternative home exercise program for older adults in the rehabilitation of COPD .

###24534013
BACKGROUND	Inflammation impairs cognitive performance and is implicated in the progression of neurodegenerative disorders .
BACKGROUND	Rodent studies demonstrated key roles for inflammatory mediators in many processes critical to memory , including long-term potentiation , synaptic plasticity , and neurogenesis .
BACKGROUND	They also demonstrated functional impairment of medial temporal lobe ( MTL ) structures by systemic inflammation .
BACKGROUND	However , human data to support this position are limited .
METHODS	Sequential fluorodeoxyglucose positron emission tomography together with experimentally induced inflammation was used to investigate effects of a systemic inflammatory challenge on human MTL function .
METHODS	Fluorodeoxyglucose positron emission tomography scanning was performed in 20 healthy participants before and after typhoid vaccination and saline control injection .
METHODS	After each scanning session , participants performed a virtual reality spatial memory task analogous to the Morris water maze and a mirror-tracing procedural memory control task .
RESULTS	Fluorodeoxyglucose positron emission tomography data demonstrated an acute reduction in human MTL glucose metabolism after inflammation .
RESULTS	The inflammatory challenge also selectively compromised human spatial , but not procedural , memory ; this effect that was independent of actions on motivation or psychomotor response .
RESULTS	Effects of inflammation on parahippocampal and rhinal glucose metabolism directly mediated actions of inflammation on spatial memory .
CONCLUSIONS	These data demonstrate acute sensitivity of human MTL to mild peripheral inflammation , giving rise to associated functional impairment in the form of reduced spatial memory performance .
CONCLUSIONS	Our findings suggest a mechanism for the observed epidemiologic link between inflammation and risk of age-related cognitive decline and progression of neurodegenerative disorders including Alzheimer 's disease .

###25911172
BACKGROUND	Duration of bladder catheterisation after female genital fistula repair varies widely .
BACKGROUND	We aimed to establish whether 7 day bladder catheterisation was non-inferior to 14 days in terms of incidence of fistula repair breakdown in women with simple fistula .
METHODS	In this randomised , controlled , open-label , non-inferiority trial , we enrolled patients at eight hospitals in the Democratic Republic of the Congo , Ethiopia , Guinea , Kenya , Niger , Nigeria , Sierra Leone , and Uganda .
METHODS	Consenting patients were eligible if they had a simple fistula that was closed after surgery and remained closed 7 days after surgery , understood study procedures and requirements , and agreed to return for follow-up 3 months after surgery .
METHODS	We excluded women if their fistula was not simple or was radiation-induced , associated with cancer , or due to lymphogranuloma venereum ; if they were pregnant ; or if they had multiple fistula .
METHODS	A research assistant at each site randomly allocated participants 1:1 ( randomly varying block sizes of 4-6 ; stratified by country ) to 7 day or 14 day bladder catheterisation ( via a random allocation sequence computer generated centrally by WHO ) .
METHODS	Outcome assessors were not masked to treatment assignment .
METHODS	The primary outcome was fistula repair breakdown , on the basis of dye test results , any time between 8 days after catheter removal and 3 months after surgery .
METHODS	The non-inferiority margin was 10 % , assessed in the per-protocol population .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01428830 .
RESULTS	We randomly allocated 524 participants between March 7 , 2012 , and May 6 , 2013 ; 261 in the 7 day group and 263 in the 14 day group .
RESULTS	In the per-protocol analysis , ten ( 4 % ) of 250 patients had repair breakdown in the 7 day group ( 95 % CI 2-8 ) compared with eight ( 3 % ) of 251 ( 2-6 ) in the 14 day group ( risk difference 08 % [ 95 % CI -28 to 45 ] ) , meeting the criteria for non-inferiority .
CONCLUSIONS	7 day bladder catheterisation after repair of simple fistula is non-inferior to 14 day catheterisation and could be used for management of women after repair of simple fistula with no evidence of a significantly increased risk of repair breakdown , urinary retention , or residual incontinence up to 3 months after surgery .
BACKGROUND	US Agency for International Development .

###25675559
OBJECTIVE	To compare the efficacy difference in treatment of borderline hypertension between acupuncture combined with anti-hypertensive plaster and simple acupuncture .
METHODS	Sixty patients of borderline hypertension were randomized into an observation group and a control group , 30 cases in each one .
METHODS	In the observation group , acupuncture was applied to Fengchi ( GB 20 ) , Taichong ( LR 3 ) and the others , once a day , 5 treatments made one session .
METHODS	There were 2 days at interval among the sessions .
METHODS	Totally , 4 sessions were required .
METHODS	Additionally , in combination , the anti-hypertensive plaster was prepared with the fine powder of Chuanxiong ( ligusticum wallichii ) and Wuzhuyu ( fructus evodiae ) at 1.1 and mixed with vinegar .
METHODS	The plaster was applied to the umbilicus , once every two days , totally 15 times were required .
METHODS	In the control group , acupuncture was given simply .
METHODS	The selected acupoints and operation were the same as the observation group .
METHODS	Before and after treatment , blood pressure and syndrome score were observed and the short-term and long-term efficacies were assessed in the two groups .
RESULTS	After treatment , the systolic pressure and diastolic pressure were reduced as compared with those before treatment in the two groups ( all P < 0.001 ) , and the differences were significant in comparison between the observation group and the control group ( P < 0.01 , P < 0.05 ) .
RESULTS	The syndrome score after treatment was reduced as compared with that before treatment in the two groups ( both P < 0.001 ) and the difference was not significant in comparison between the two groups ( P > 0.05 ) .
RESULTS	In follow-up of the effective cases and remarkably effective cases in 3 months , the total effective rate in the observation group was 89.3 % ( 25/28 ) and was 60.0 % ( 15/25 ) in the control group , indicating the significant difference in comparison ( P < 0.05 ) .
CONCLUSIONS	Acupuncture combined with anti-hypertensive plaster is the effective method in prevention and treatment of borderline hypertension .
CONCLUSIONS	Regarding the long-term efficacy , this combined therapy achieves the superior improvement in the symptoms and physical signs of the patients of borderline hypertension as compared with simple acupuncture .

###24459138
BACKGROUND	Anticoagulation for the haemodialysis circuit in patients treated with oral anticoagulation poses additional haemorrhagic risk .
BACKGROUND	The few available data suggest that tapering or even stopping heparinization is feasible and the HeprAN membrane with grafted heparin was developed to decrease heparin dose .
BACKGROUND	The objective of our study was to evaluate the need for additional anticoagulation in patients on long-term oral anticoagulation , according to the type of membrane used .
METHODS	This is a prospective , randomized , crossover bifactorial trial in haemodialysed patients on oral anticoagulation .
METHODS	Each patient had four haemodialysis sessions with two different membranes [ HeprAN or polysulphone ( PS ) ] and with or without enoxaparin .
METHODS	Clinical coagulation was evaluated by the need for premature ending and by a visual score ( Janssen scale ) .
METHODS	Coagulation activation markers were also measured : d-dimers , prothrombin fragments 1 + 2 , thrombin-antithrombin complexes , tissue factor pathway inhibitor and platelet factor-4 .
RESULTS	Ten patients were included ( M/F = 4/6 , mean age 63 15 years ) .
RESULTS	None of the 40 sessions ended prematurely .
RESULTS	The clotting scores were similar with or without enoxaparin ( dialyser : 1.49 0.19 versus 1.53 0.17 , P = 0.97 ; bubble trap : 0.75 0.19 versus 0.78 0.22 , P = 0.62 ) and with the polysulphone or the HeprAN membrane ( dialyser : 1.54 0.20 versus 1.47 0.16 , P = 0.65 ; bubble trap : 0.74 0.22 versus 0.79 0.19 , P = 0.58 ) .
RESULTS	There was no significant difference in coagulation activation markers between dialysis modalities ; however , dialysis efficacy was significantly greater with the PS membrane ( 1.58 0.07 versus 1.43 0.06 , P = 0.02 ) .
CONCLUSIONS	These results suggest that haemodialysis without additional anticoagulation is possible in patients with oral anticoagulation .
CONCLUSIONS	The HeprAN membrane did not provide any additional benefit compared with a PS membrane .

###25173079
OBJECTIVE	In forensic settings , individuals who experience a traumatic event are often encouraged to recall it soon afterwards to preserve their memory for it .
OBJECTIVE	Some theories of the development of post-traumatic stress disorder ( PTSD ) suggest that this may increase psychopathology .
OBJECTIVE	The primary aim of the study was to examine the effect of immediate recall of a trauma analogue video on psychopathology .
METHODS	Eighty-five undergraduate students were randomised to view a video of a car accident , described as either a real event ( high stress ) or training event ( low stress ) .
METHODS	They then completed either the Self-Administered Interview ( SAI , Gabbert , Hope , & Fisher , 2009 ) or a filler task .
METHODS	All participants returned one week later to provide an account of the event .
RESULTS	As predicted , participants in the SAI early recall task condition remembered the video content better one week after seeing the video , shown both by their greater recall of correct details and greater rejection of misinformation .
RESULTS	However , completing the SAI resulted in higher anxiety immediately afterwards , and more severe PTSD-like symptoms one week later , compared to control condition .
RESULTS	PTSD intrusion-like symptoms also predicted more accurate recall , while avoidance predicted poorer memory .
CONCLUSIONS	While the trauma analogue video used in this study has been previously used , and did effectively trigger post-traumatic-like symptoms , it is unclear how well these results generalise to actual trauma situations .
CONCLUSIONS	These results suggest the relationship between PTSD symptoms and memory might be more complex than previously recognised , with intrusive phenomena possibly promoting memory and avoidance symptoms compromising memory .

###25082214
BACKGROUND	The study explores whether messages about the physical activity levels of the majority ( i.e. normative messages ) affect young adults ' intention to engage in regular physical activity .
METHODS	An experimental survey among 16 to 24 year-olds in Bulgaria , Croatia and Romania ( n = 1200 ) was conducted in March 2013 .
METHODS	A control group received no message ; one treatment group was told that the majority was physically active ( positive message ) ; and another treatment group was told that the majority was not physically active ( negative message ) .
RESULTS	Both the positive and ( unexpectedly ) the negative normative messages showed a significant and positive effect on intention to be physically active .
RESULTS	There was no difference between the effects of the messages .
CONCLUSIONS	Normative messages affect intention , which is encouraging for public health campaigns .
CONCLUSIONS	The effect of the positive message confirms previous findings on conformity to the norm ; the effect of the negative message is unexpected and requires further research to be understood .

###24297792
BACKGROUND	Fibroblast growth factor 19 ( FGF19 ) improves glycemic control in diabetic animals and is secreted from the gastrointestinal tract after meals in response to bile acid stimulation .
OBJECTIVE	We sought to understand how ingestion of carbohydrates , protein or lipids affect both FGF19 and bile acid concentrations in human plasma , with the hypothesis that variation in the bile acid response to different macronutrients would predict differences in plasma FGF19 levels .
METHODS	This was a randomized , within-subjects crossover study .
METHODS	The study was conducted at a university clinical research center .
METHODS	There were 16 healthy human subjects included in the study .
METHODS	Isocaloric , isovolemic beverages composed primarily of carbohydrates , proteins , or lipids were provided to each participant on 3 separate occasions .
METHODS	The magnitudes of postprandial rises of plasma FGF19 and total bile acid levels were determined .
RESULTS	All beverages induced an initial transient decline of plasma FGF19 levels during the first 60 minutes after consumption .
RESULTS	For FGF19 , the ingestion of carbohydrate was associated with the fastest and highest increase of plasma levels , returning to baseline at 5 hours .
RESULTS	By comparison , the protein beverage induced a modest but significant elevation of FGF19 levels that peaked at the end of the 6-hour sampling interval , whereas a lipid beverage was without effect .
RESULTS	In contrast , total bile acid levels increased in plasma only in response to a high-lipid beverage , demonstrating a marked divergence between the FGF19 and bile acid response to lipid vs carbohydrate .
CONCLUSIONS	A bile acid-independent mechanism is implicated in the effect of meals to raise plasma FGF19 concentrations .

###24825343
OBJECTIVE	In this clinical trial , we aimed to compare three means of performing chronic hemodialysis in patients with contra-indication to systemic heparinization .
METHODS	This open-label monocentric randomized n-of-one trial , conducted in a single tertiary care center , recruited chronic hemodialysis patients with a contra-indication to systemic heparinization for at least 3 consecutive sessions .
METHODS	All patients underwent hemodialysis with an AN69ST dialyzer , and were administered three alternative dialysis procedures in a random sequence : intermittent saline flushes , constant saline infusion , or pre-dialysis heparin coating of the membrane .
METHODS	The primary outcome was the need to interrupt the dialysis session because of clotting events due to either ( i ) a complete coagulation of the circuit ; ( ii ) a partial coagulation of the circuit ; ( iii ) a > 50 % rise over baseline in the venous pressure .
RESULTS	At the end of the inclusion period ( May , 2007 to December , 2008 ) , the number of patients to include ( n = 75 ) was not reached : only 46 patients were included and underwent randomization .
RESULTS	The study was terminated , and statistical analysis took into account 224 hemodialysis sessions performed in 44 patients with analyzable data .
RESULTS	Heparin adsorption was associated with a significant reduction of the need to interrupt the dialysis session because of clotting events : odds ratio 0.3 ( CI 95 % 0.2 to 0.6 ; p < 0.001 , versus intermittent saline flushes ) .
RESULTS	Heparin adsorption was also associated with higher odds for performing > 3 h dialysis sessions and for having complete blood restitution .
RESULTS	There were no significant effects of the dialysis procedure on weight loss , online ionic dialysance , and adverse events .
CONCLUSIONS	Heparin-coated AN69ST dialysis membrane is a safe and effective method to avoid or delay per-dialytic clotting events in patients with contra-indication to systemic anticoagulation .
CONCLUSIONS	However , results are not generalizable safely to patients with active bleeding , since weak heparinemia , not assessed in this study , may occur .
BACKGROUND	ClinicalTrials.gov NCT00473109 .

###24969380
OBJECTIVE	To examine the effects of galantamine and risperidone on agitation in patients with dementia .
METHODS	A total of 100 patients with dementia and neuropsychiatric symptoms ( mean age SD : 78.6 7.5 years ; 67 % female ) were included in this 12-week , randomized , parallel-group , controlled , single-center trial .
METHODS	The participants received galantamine ( n = 50 ; target dose : 24 mg ) or risperidone ( n = 50 ; target dose : 1.5 mg ) for 12 weeks .
RESULTS	Both galantamine and risperidone treatment resulted in reduced agitation .
RESULTS	However , risperidone showed a significant advantage over galantamine both at week 3 ( mean difference in total Cohen-Mansfield Agitation Inventory score : 3.7 points ; p = 0.03 ) and at week 12 ( 4.3 points ; p = 0.01 ) .
CONCLUSIONS	Agitation improved in both groups , even if the treatment effects were more pronounced in the risperidone group ; however , the effects on cognition and other aspects of tolerability were stronger with galantamine .

###25469821
OBJECTIVE	To determine the reliability of patient reports of pain intensity during the application of physical tests .
METHODS	A single examiner required participants to use the numeric pain rating scale ( NPRS ) to report the intensity of pain provoked during physical testing of the hip .
METHODS	Standardized versions of 14 physical tests were used on 18 people with hip pain .
METHODS	Tests were repeated at 1 hour and 2-7 days later .
METHODS	Within - and between-session reliability of reports of pain intensity was calculated using intraclass correlation coefficients ( ICCs ) and Lin 's concordance correlation coefficients ( CCCs ) .
METHODS	Standard errors of measurement ( SEMs ) were calculated .
RESULTS	ICC/CCC values for within-session reports of pain intensity ranged from 0.34 ( 95 % confidence interval [ 95 % CI ] -0.08 , 0.66 ) to 0.88 ( 95 % CI 0.73 , 0.95 ) .
RESULTS	Patients demonstrated `` substantial '' or `` almost perfect '' reliability in reporting pain intensity with 9 of 14 tests and `` moderate '' reliability with 3 tests .
RESULTS	Two tests were unreliable ( ICC 0.35 and 0.34 ) .
RESULTS	ICC/CCC values for between-session reports of pain intensity ranged from -0.05 ( 95 % CI -0.42 , 0.34 ) to 0.84 ( 95 % CI 0.44 , 0.95 ) .
RESULTS	Patients demonstrated substantial or almost perfect reliability in reporting pain intensity with 11 of 14 tests .
RESULTS	Two tests were unreliable ( ICC 0.26 and -0.05 ) .
RESULTS	The average SEM value of 0.9 points on the NPRS was the same for both within - and between-session testing ( range 0.6-1 .6 ) .
CONCLUSIONS	Patient reports of the intensity of pain provoked by physical tests are sufficiently reliable to be clinically useful .
CONCLUSIONS	However , the SEM of 0.9 points should be considered when precise calculations of changes in pain intensity are important .

###25336514
OBJECTIVE	Mechanisms , acute management , and outcomes for patients who experience intracerebral hemorrhage may differ from patients with ischemic stroke .
OBJECTIVE	Studies of very early rehabilitation have been mainly undertaken in patients with ischemic stroke , and it is unknown if benefits apply to those with intracerebral hemorrhage .
OBJECTIVE	We hypothesized that early rehabilitation , within 48 hours of stroke , would improve survival and functional outcomes in patients with intracerebral hemorrhage .
METHODS	This was a multicenter , randomized controlled study , with blinded assessment of outcome at 3 and 6 months .
METHODS	Eligible patients were randomized to receive standard care or standard care plus early rehabilitation .
METHODS	Primary outcome includes survival .
METHODS	Secondary outcomes includes health-related quality of life using the 36-item Short Form Questionnaire , function measured with the modified Barthel Index , and anxiety measured with the Zung Self-Rated Anxiety Scale .
RESULTS	Two hundred forty-three of 326 patients were randomized ( mean age , 59 years ; 56 % men ) .
RESULTS	At 6 months , patients receiving standard care were more likely to have died ( adjusted hazard ratio , 4.44 ; 95 % confidence interval [ CI ] , 1.24-15 .87 ) ; for morbidity outcomes , a 6-point difference in the Physical Component Summary score of the 36-item Short Form Questionnaire ( 95 % CI , 4.2-8 .7 ) , a 7-point difference for the Mental Component Summary score ( 95 % CI , 4.5-9 .5 ) , a 13-point difference in Modified Barthel Index scores ( 95 % CI , 6.8-18 .3 ) , and a 6-point difference in Self-Rating Anxiety Scale scores ( 95 % CI , 4.4-8 .3 ) was reported in favor of the intervention groups .
CONCLUSIONS	For the first time , we have shown that commencing rehabilitation within 48 hours of intracerebral hemorrhage improves survival and functional outcomes at 6 months after stroke in hospitalized patients in China .
BACKGROUND	http://www.chictr.org/en .
BACKGROUND	Unique identifier : ChiCTR-TRC-13004039 .

###24630880
OBJECTIVE	This study sought to evaluate the outcomes of endovascular treatment with covered versus bare Cheatham-platinum stents ( NuMed , Hopkinton , New York ) in coarctation of aorta ( CoA ) patients .
BACKGROUND	Covered stenting has been newly recognized as a useful therapeutic method for patients with native CoA , but there has been no study comparing the use of covered stents with bare stents for treating CoA .
METHODS	In this randomized clinical trial , 120 patients with a mean age of 23.60 10.99 years ( range 12 to 58 years , 79 men ) , with post-ductal , short-segment , severe native CoA underwent implantation of bare Cheatham-Platinum ( bCP ) ( n = 60 ) or covered Cheatham-Platinum ( cCP ) ( n = 60 ) stents .
METHODS	Patients were followed clinically at 1 , 3 , 6 , and 12 months after the stenting and yearly thereafter .
METHODS	During follow-up , multislice computed tomography ( 64 slices ) was scheduled to assess any complications .
RESULTS	The procedural success rate was 100 % in both groups .
RESULTS	Patients were followed for 31.1 19.2 months .
RESULTS	Although recoarctation was seen only in the bCP group during follow-up , the difference betweengroups did not reach statistical significance ( 6.7 % vs. 0 % ; p = NS ) .
RESULTS	Two cases of pseudoaneurysm ( 3.3 % ) occurred in the cCP group , but none was observed in the bCP group ( p = NS ) .
RESULTS	Normotensive statussignificantly increased during follow-up in both groups ( from 15 % to 73.3 % in the bCP group and16 .7 % to78 .3 % in the cCP group , p < 0.001 for each group and not significant between groups ) .
CONCLUSIONS	Implanting bCP and cCP stents have very high success rates with remarkable hemodynamic effects in severe native CoA patients .
CONCLUSIONS	Patients undergoing cCP stent implantation experienced a nonsignificantly lower recoarctation rate and a higher occurrence of pseudoaneurysm formation with respect to bCP stenting during follow-up .
CONCLUSIONS	These findings indicate that CoA stenting isasafe procedure .
CONCLUSIONS	( Endovascular Stenting With Covered CP Stent Compared With Bare CP Stent forAdultPatients With Coarctation : The Initial and Intermediate-Term Follow-Up Results ; IRCT201012045311N1 ) .

###24738467
OBJECTIVE	To observe the clinical effect of low-dose once-daily tadalafil combined with Shuganyiyang Capsules in the treatment of mild-to-moderate erectile dysfunction ( ED ) .
METHODS	Ninety patients with mild-to-moderate ED were equally randomized to groups A , B and C to receive Shuganyiyang Capsules , tadalafil , and tadalafil + Shuganyiyang Capsules , respectively .
METHODS	The scores of the patients on IIEF-5 and SF-PAIRS ( 15-Item Short Form of Psychological Interpersonal Relationship Scales ) were recorded before and at 1 and 3 months after treatment .
RESULTS	The IIEF-5 scores of groups A , B and C were 10.13 + / - 1.55 , 11.00 + 1.60 and 10.73 + / - 1.91 before treatment , and 13.77 + / - 2.11 , 17.77 + / - 2.13 and 17.17 + / - 3.84 at 1 month after treatment , significantly higher in B and C than in A ( P < 0.001 ) , but with no remarkable difference between B and C ( P = 0.411 ) .
RESULTS	At 3 months after treatment , the IIEF-5 scores were 15.77 + / - 2.05 , 18.07 + / - 2.24 and 19.37 + / - 3.76 in the three groups , dramatically higher in B and C than in A ( P < 0.001 ) as well as in C than in B ( P < 0.05 ) .
RESULTS	The scores on sexual self-confidence , sexual spontaneity and time concerns in SF-PAIRS were 3.90 + / -0.80 , 8.67 + / - 1.94 and 14.43 + / - 1.92 before medication , 5.83 + / - 1.02 , 9.90 + / - 1.75 and 11.17 + / - 1.68 at 1 month and 6.73 + / - 0.98 , 11.07 + / - 2.08 and 10.67 + / -1.60 at 3 months after medication in group A ; 4.17 + / - 0.87 , 9.37 + / -1.43 and 14.47 + / -1.57 before medication , 6.47 + / -0.78 , 10.83 + / - 2.18 and 10.20 + / -1.56 at 1 month and 6.83 + / -0.91 , 11.30 + / - 1.88 and 9.47 + / - 1.57 at 3 months in group B ; and 4.23 + / -0.94 , 9.50 + / - 1.89 and 14.67 + / - 2.91 before medication , 8.03 + / - 1.67 , 13.43 + / -1.10 and 9.70 + / -1.21 at 1 month and 8.93 + / - 1.78 , 14.70 + / - 1.26 and 8.87 + / - 0.97 at 3 months in group C. Compared with the baseline , the SF-PAIRS scores of the three groups were all significantly improved after treatment ( P < 0.05 ) , and markedly higher in C than in the other two groups ( P < 0.05 ) .
CONCLUSIONS	Low-dose once-daily tadalafil combined with Shuganyiyang Capsules is obviously effective in the treatment of mild-to-moderate ED , which not only improves the patients ` erectile function , sexual self-confidence and sexual spontaneity , but also reduces their time concerns .

###24847894
OBJECTIVE	Milligan-Morgan hemorrhoidectomy ( MM ) is still the most common treatment for grades III and IV hemorrhoids despite prolonged post-operative anal pain and wound healing .
OBJECTIVE	This multicenter , double blind , randomized , controlled trial was designed to assess the safety and the efficacy of anal wound cleansing with Triclosan ( Proctocid ) in the control of symptoms and healing time after MM .
METHODS	A total of 113 patients with grades III and IV hemorrhoids , undergoing open hemorroidectomy by diathermy or Ligasure vessel sealing device , were randomly assigned to Triclosan or sodium hypochlorite solution .
METHODS	All patients received analgesics and a fiber-rich diet after hemorrhoidectomy .
METHODS	Postoperative anal pain , bleeding and/or secretion and itch were assessed 7 , 14 and 21 days after hemorrhoidectomy by a Visual Analogue Scale ( VAS ) and the day of complete re-epithelialization of anal wounds was recorded .
RESULTS	Fifty-five patients were randomized for Triclosan treatment and 58 for the control drug .
RESULTS	The two groups were comparable for demographics , severity of hemorrhoids and technique used for the hemorrhoidectomy .
RESULTS	The comparison of days to get complete anal wound healing shows a trend of significance ( P = 0.05 ) for the Triclosan group .
RESULTS	Bleeding and/or secretion , anal pain and itch were significantly better ( P = 0.003 ; P < 0.0001 and P = 0.01 , respectively ) .
CONCLUSIONS	Triclosan solution for the treatment of post-hemorrhoidectomy wounds is safe and improves the control of post-operative symptoms and wound healing time compared to sodium hypochlorite .

###24575769
OBJECTIVE	To determine if transversus abdominis plane anesthetic blockage ( TAP block ) diminishes early postoperative pain scores and facilitates ambulatory management following total laparoscopic hysterectomy .
METHODS	Randomized triple blind trial .
METHODS	Gynecological endoscopy unit at a referral center for laparoscopic surgery .
METHODS	A total of 197 patients .
METHODS	Comparison of a treatment group receiving TAP block with bupivacaine 0.25 % and placebo group with comparably placed bilateral injection of sterile saline solution .
METHODS	Pain scores at discharge 24 , 48 and 72h after surgery , opioid requirement after procedure .
RESULTS	Patients who had TAP block had a significant reduction in their pain score at discharge compared with the placebo group ( p = 0.017 ) .
RESULTS	There were no significant differences in the pain scores between groups at 24h ( 95 % CI 1.36-0 .133 , p = 0.237 ) , 48h ( 95 % CI 0.689-0 .465 , p = 0.702 ) and 72h ( 95 % CI -0.631 to 0.223 , p = 0.347 ) .
RESULTS	No differences were found between the groups regarding opioid requirements following the procedure ( ( 2 ) = 3.62 , p = 0.46 ) .
CONCLUSIONS	Although TAP block after a total laparoscopic hysterectomy reduced the pain score at discharge compared with placebo , its role in this setting is debatable due to the possible lack of clinical significance of the small difference found .

###24225157
BACKGROUND	Studies done in Asia have shown that a regimen of S-1 plus oxaliplatin ( SOX ) has promising efficacy and safety in patients with metastatic colorectal cancer .
BACKGROUND	We aimed to establish whether SOX plus bevacizumab is non-inferior to mFOLFOX6 ( modified regimen of leucovorin , fluorouracil , and oxaliplatin ) plus bevacizumab as first-line chemotherapy for metastatic colorectal cancer .
METHODS	We undertook an open-label , non-inferiority , randomised phase 3 trial in 82 sites in Japan .
METHODS	We enrolled individuals aged 20-80 years who had metastatic colorectal cancer , had an Eastern Cooperative Oncology Group performance status of 0 or 1 , had assessable lesions , had received no previous chemotherapy or radiotherapy , could take drugs orally , and had adequate organ function .
METHODS	Eligible patients were randomly assigned ( 1:1 ) to receive either mFOLFOX6 plus bevacizumab ( on day 1 of each 2-week cycle , 5 mg/kg intravenous infusion of bevacizumab and a simultaneous intravenous infusion of 85 mg/m ( 2 ) oxaliplatin , 200 mg/m ( 2 ) l-leucovorin , 400 mg/m ( 2 ) bolus fluorouracil , and 2400 mg/m ( 2 ) infusional fluorouracil ) or SOX plus bevacizumab ( on day 1 of each 3-week cycle , 75 mg/kg intravenous infusion of bevacizumab and 130 mg/m ( 2 ) intravenous infusion of oxaliplatin ; assigned dose of S-1 twice a day from after dinner on day 1 to after breakfast on day 15 , followed by 7-day break ) .
METHODS	Randomisation was done centrally with the minimisation method , with stratification by institution and whether postoperative adjuvant chemotherapy had been given .
METHODS	Participants , investigators , and data analysts were not masked to treatment assignment .
METHODS	The primary endpoint was progression-free survival ( PFS ) , which was defined as the interval between enrolment and progressive disease ( 20 % increase in sum of longest dimensions of target lesions from baseline , or appearance of new lesions ) or death , whichever came first .
METHODS	The primary analysis was done by modified intention to treat .
METHODS	This trial is registered with the Japan Pharmaceutical Information Center , number JapicCTI-090699 .
RESULTS	Between Feb 1 , 2009 , and March 31 , 2011 , 512 patients underwent randomisation .
RESULTS	256 patients assigned to receive SOX plus bevacizumab and 255 assigned to receive mFOLFOX6 plus bevacizumab were included in the primary analysis .
RESULTS	Median PFS was 115 months ( 95 % CI 107-132 ) in the group assigned to mFOLFOX6 plus bevacizumab and 117 months ( 107-129 ) in the group assigned to SOX plus bevacizumab ( HR 104 , 95 % CI 086-127 ; less than non-inferiority margin of 133 , pnon-inferiority = 0014 ) .
RESULTS	The most common haematological adverse events of grade 3 or higher were leucopenia ( 21 [ 8 % ] of 249 patients given mFOLFOX6 plus bevacizumab included in safety analysis vs six [ 2 % ] of 250 given SOX plus bevacizumab ; p = 00029 ) and neutropenia ( 84 [ 34 % ] vs 22 [ 9 % ] ; p < 00001 ) .
RESULTS	Grade 3 or higher anorexia ( 13 [ 5 % ] vs three [ 1 % ] ; p = 0019 ) and diarrhoea ( 23 [ 9 % ] vs seven [ 3 % ] ; p = 00040 ) were significantly more common in patients given SOX plus bevacizumab than in those given mFOLFOX6 plus bevacizumab .
RESULTS	We recorded seven treatment-related deaths ( three in the group given mFOLFOX6 plus bevacizumab ; four in that given SOX plus bevacizumab ) .
CONCLUSIONS	SOX plus bevacizumab is non-inferior to mFOLFOX6 plus bevacizumab with respect to PFS as first-line treatment for metastatic colorectal cancer , and could become standard treatment in Asian populations .
BACKGROUND	Taiho .

###24854296
BACKGROUND	The use of 1-hydroxylated vitamin D therapy to control secondary hyperparathyroidism in renal failure patients has been a success story , culminating with the demonstration of increased life expectancy in patients treated with these compounds .
BACKGROUND	However , hypercalcemic episodes have been a recurrent problem with these therapies and have resulted in the added use of calcium mimetics .
BACKGROUND	Clearly there is good reason to search for improved vitamin D therapy .
BACKGROUND	In our inventory of vitamin D compounds , 2-methylene-19-nor - ( 20S ) -1,25 - dihydroxyvitamin D3 ( 2MD ) surfaced as a potential candidate .
BACKGROUND	This was based on its preferential localization in the parathyroid gland and a clear suppression of serum parathyroid hormone ( PTH ) levels without a change in serum calcium in a clinical trial in postmenopausal women .
METHODS	2MD has now been tested in the rat 5/6-nephrectomy model of renal failure , and in postmenopausal women to determine if it can suppress serum PTH at doses that do not elevate serum calcium and serum phosphorus concentrations .
RESULTS	Daily oral treatment of uremic rats on 2.5 ng/bw/day of 2MD dramatically suppressed PTH without a change in serum calcium or serum phosphorus .
RESULTS	Further , PTH was suppressed in postmenopausal women after only 3 daily oral doses of 2MD that continued for 4 weeks with no change in serum calcium or serum phosphorus .
CONCLUSIONS	These results coupled with a pharmacokinetic half-life of ~ 24 h suggest that 2MD given either daily or at the time of dialysis may be a superior therapy for secondary hyperparathyroidism in chronic renal failure patients .

###24248532
OBJECTIVE	Our aim was to investigate the relationship between mutant p53 and the prognosis of malignant glioma treated with temozolomide , and the regulation of mutant TP53 induced drug resistance , by molecular experimentation and a clinical trial .
METHODS	Adult patients with newly surgical diagnosed glioblastoma were randomly assigned to receive either temozolomide or semustine after radiation treatment .
METHODS	The statuses of TP53 and expression of TP53 and O ( 6 ) - methylguanine DNA-methyltransferase ( MGMT ) were determined retrospectively in tumor tissue from enrolled patients .
METHODS	The primary end point was overall survival .
METHODS	Synthetic small interfering RNA was used to knock down mutant TP53 in T98G and U138 cells , which are human glioblastoma cells with a P53 mutation , by screening of exons 4-8 .
METHODS	Viable cell survival was measured when these cells were exposed to temozolomide or semustine .
METHODS	Expression of MGMT at the messenger RNA level was also determined .
RESULTS	The overall survival was 34.3 % at 2 years , 22.9 % at 3 years , 11.4 % at 4 years , and 8.6 % at 5 years with temozolomide , versus 18.2 , 12.1 , 3.0 , and 0 % , respectively , with semustine .
RESULTS	TP53 mutation and expression of mutant TP53 and MGMT showed significant inverse correlations with overall survival .
RESULTS	Knockdown of mutant TP53 led to a fivefold increase in chemosensitivity to temozolomide but not semustine .
RESULTS	Mutant TP53 knockdown induced down-regulation of MGMT expression .
CONCLUSIONS	Mutant TP53 is strongly associated with a poor prognosis for overall survival in patients with glioblastoma .
CONCLUSIONS	Also , TP53 mutation may decrease the chemosensitivity of glioblastoma to temozolomide by increasing MGMT expression .

###24776332
OBJECTIVE	Coronary bifurcation lesions can be approached using a simple or a complex strategy .
OBJECTIVE	In clinical trials with first-generation drug-eluting stents , the complex strategy was not superior to the simple approach .
OBJECTIVE	However , to date , the best strategy when using second-generation drug-eluting stents has not been defined .
METHODS	We performed a prospective randomized study comparing a simple vs a complex strategy involving T-stenting for the percutaneous revascularization of bifurcation lesions using the everolimus-eluting stent .
METHODS	Angiographic and clinical follow-up were performed at 9 months .
RESULTS	We included 70 lesions in 69 patients , who were randomized to the simple ( 34 lesions , 33 patients ) or complex strategy ( 36 lesions and patients ) .
RESULTS	In all , 85.6 % of the lesions included were true bifurcations .
RESULTS	The crossover rate was 17.1 % .
RESULTS	The binary restenosis rate was 12.1 % , with no differences between the groups .
RESULTS	Side branch restenosis tended to be higher with the simple strategy in the intention to treat analysis ( 10.7 % vs 0 % ) but not in the per protocol analysis ( 5.9 % vs 4.2 % ) .
RESULTS	The incidence of major adverse cardiac events ( cardiac death , myocardial infarction , and target vessel revascularization ) was 9.2 % , with no differences between groups .
RESULTS	There were no cases of stent thrombosis .
CONCLUSIONS	According to the clinical and angiographic findings , the complex strategy was not significantly superior to the simple approach in the revascularization of bifurcation lesions with second-generation everolimus-drug eluting stents .

###24993276
BACKGROUND	Current literature supports the thought that anesthesia and analgesia administered perioperatively for an anterior cruciate ligament ( ACL ) reconstruction have a great influence on time to effective rehabilitation during the first week after hospital discharge .
OBJECTIVE	The aim of this study is to answer the research question is there a difference in clinical outcomes between the use of a femoral nerve block with spinal anesthesia versus spinal analgesia alone for people undergoing ACL reconstruction ?
METHODS	ACL reconstruction with spinal anesthesia and patient sedation ( Group one ) ; and spinal anesthesia with patient sedation and an additional femoral nerve block ( Group two ) .
METHODS	Patients were re-evaluated for pain , range of motion ( ROM ) , active contraction of the quadriceps , and a Functional Independence Measure ( FIM ) scoring scale .
RESULTS	Spinal anesthesia with a femoral nerve block demonstrates pain relief 6h after surgery ( VAS 0.37 ; p = 0.007 ) .
RESULTS	From the third ( VAS = 4.56 ; p = 0.028 ) to the seventh ( VAS = 2.87 ; p = 0.05 ) days after surgery , this same nerve blockage delivered higher pain scores .
RESULTS	Patients had a similar progressive improvement on knee joint range of motion with or without femoral nerve block ( p < 0.002 ) .
RESULTS	Group one and two had 23.75 and 24.29 6h after surgery and 87.81 and 85.36 of knee flexion after 48h post op .
CONCLUSIONS	Spinal anesthesia associated with a femoral nerve block had no additional benefits on pain control after the third postoperative day .
CONCLUSIONS	There were no differences between groups concerning ability for knee flexion and to complete daily activities during postoperative period .
METHODS	Randomized Clinical Trial Level I.

###24255071
OBJECTIVE	Tasquinimod ( Active Biotech ) is an oral immunomodulatory , anti-angiogenic , and anti-metastatic agent that delayed metastatic disease progression in a randomized placebo-controlled phase II trial in men with metastatic castration-resistant prostate cancer ( mCRPC ) .
OBJECTIVE	Here , we report long-term survival with biomarker correlates from this trial .
METHODS	Two hundred and one ( 134 tasquinimod and 67 placebo ) men with mCRPC were evaluated .
METHODS	Forty-one men randomized to placebo crossed over to tasquinimod .
METHODS	Survival data were collected with a median follow-up time of 37 months .
METHODS	Exploratory biomarker studies at baseline and over time were collected to evaluate potential mechanism-based correlates with tasquinimod efficacy including progression-free survival ( PFS ) and overall survival ( OS ) .
RESULTS	With 111 mortality events , median OS was 33.4 months for tasquinimod versus 30.4 months for placebo overall , and 34.2 versus 27.1 months in men with bone metastases ( n = 136 ) , respectively .
RESULTS	Multivariable analysis demonstrated an adjusted HR of 0.52 [ 95 % confidence interval ( CI ) , 0.35-0 .78 ; P = 0.001 ] for PFS and 0.64 ( 95 % CI , 0.42-0 .97 ; P = 0.034 ) for OS , favoring tasquinimod .
RESULTS	Time-to-symptomatic progression was improved with tasquinimod ( P = 0.039 , HR = 0.42 ) .
RESULTS	Toxicities tended to be mild in nature and improved over time .
RESULTS	Biomarker analyses suggested a favorable impact on bone alkaline phosphatase and lactate dehydrogenase ( LDH ) over time and a transient induction of inflammatory biomarkers , VEGF-A , and thrombospondin-1 levels with tasquinimod .
RESULTS	Baseline levels of thrombospondin-1 less than the median were predictive of treatment benefit .
CONCLUSIONS	The survival observed in this trial of men with minimally symptomatic mCRPC suggests that the prolongation in PFS with tasquinimod may lead to a survival advantage in this setting , particularly among men with skeletal metastases , and has a favorable risk : benefit ratio .

###25722979
BACKGROUND	The efficacy of clipping for preventing the delayed bleeding after the removal of colon polyps is still controversial .
BACKGROUND	In order to clarify this efficacy , a randomized controlled study was performed .
METHODS	One hundred and fifty-six patients with colon neoplasms ( 288 lesions ) were enrolled in the study .
METHODS	The patients were randomly divided into two groups : clipping or nonclipping groups using a sealed envelope method before the endoscopic resections .
METHODS	Eight specialists and nine residents were invited to perform this procedure .
METHODS	The risk factors and the rates of delayed bleeding after the endoscopic resections in each group were investigated .
RESULTS	There were no significant differences in the bleeding rate between the clipping and nonclipping groups , while the length of the procedure was significantly longer and the cost was higher in the clipping group than in the nonclipping group .
RESULTS	The rate of bleeding was significantly higher in cases with polyps 2 cm or larger and with a longer procedure time , while none of the other factors affected the bleeding rate .
CONCLUSIONS	This randomized controlled study revealed no significant effect of prophylactic clipping for preventing delayed bleeding after the endoscopic resection of colon polyps .

###25439693
BACKGROUND	The CLASSIC trial was done to compare adjuvant capecitabine plus oxaliplatin versus observation after D2 gastrectomy for patients with stage II or III gastric cancer .
BACKGROUND	The planned interim analysis of CLASSIC ( median follow-up 34 months ) showed that adjuvant capecitabine plus oxaliplatin significantly improved disease-free survival , the primary endpoint , compared with observation after D2 gastrectomy .
BACKGROUND	We report the 5-year follow-up data from the trial .
METHODS	CLASSIC was a phase 3 , randomised , open-label study done at 35 cancer centres , medical centres , and hospitals in China , South Korea , and Taiwan .
METHODS	Patients with stage II-IIIB gastric cancer who underwent curative D2 gastrectomy were randomly assigned ( 1:1 ) after surgery to receive adjuvant chemotherapy with capecitabine and oxaliplatin ( eight 3-week cycles of oral capecitabine 1000 mg/m ( 2 ) twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m ( 2 ) on day 1 ) for 6 months or observation alone .
METHODS	Randomisation was stratified by country and disease stage with a permuted block ( size four ) design .
METHODS	Neither patients nor investigators were masked to treatment assignment .
METHODS	The primary outcome was 3-year disease-free survival in the intention-to-treat population .
METHODS	This analysis presents the final preplanned assessment of outcomes after 5 years .
METHODS	The study is registered with ClinicalTrials.gov , NCT00411229 .
RESULTS	We enrolled 1035 patients : 520 were randomly assigned to adjuvant capecitabine and oxaliplatin , and 515 to observation .
RESULTS	Median follow-up for this analysis in the intention-to-treat population was 624 months ( IQR 54-70 ) .
RESULTS	139 ( 27 % ) patients had disease-free survival events in the adjuvant capecitabine and oxaliplatin group versus 203 ( 39 % ) patients in the observation group ( stratified hazard ratio [ HR ] 058 , 95 % CI 047-072 ; p < 00001 ) .
RESULTS	Estimated 5-year disease-free survival was 68 % ( 95 % CI 63-73 ) in the adjuvant capecitabine and oxaliplatin group versus 53 % ( 47-58 ) in the observation alone group .
RESULTS	By the clinical cutoff date , 103 patients ( 20 % ) had died in the adjuvant capecitabine and oxaliplatin group versus 141 patients ( 27 % ) in the observation group ( stratified HR 066 , 95 % CI 051-085 ; p = 00015 ) .
RESULTS	Estimated 5-year overall survival was 78 % ( 95 % CI 74-82 ) in the adjuvant capecitabine and oxaliplatin group versus 69 % ( 64-73 ) in the observation group .
RESULTS	Adverse event data were not collected after the primary analysis .
CONCLUSIONS	Adjuvant treatment with capecitabine plus oxaliplatin after D2 gastrectomy should be considered for patients with operable stage II or III gastric cancer .
BACKGROUND	F Hoffmann La-Roche and Sanofi .

###24884722
BACKGROUND	The financial costs associated with asthma care continue to increase while care remains suboptimal .
BACKGROUND	Promoting optimal self-management , including the use of asthma action plans , along with regular health professional review has been shown to be an effective strategy and is recommended in asthma guidelines internationally .
BACKGROUND	Despite evidence of benefit , guided self-management remains underused , however the potential for online resources to promote self-management behaviors is gaining increasing recognition .
BACKGROUND	The aim of this paper is to describe the protocol for a pilot evaluation of a website ` Living well with asthma ' which has been developed with the aim of promoting self-management behaviors shown to improve outcomes .
METHODS	The study is a parallel randomized controlled trial , where adults with asthma are randomly assigned to either access to the website for 12 weeks , or usual asthma care for 12 weeks ( followed by access to the website if desired ) .
METHODS	Individuals are included if they are over 16-years-old , have a diagnosis of asthma with an Asthma Control Questionnaire ( ACQ ) score of greater than , or equal to 1 , and have access to the internet .
METHODS	Primary outcomes for this evaluation include recruitment and retention rates , changes at 12 weeks from baseline for both ACQ and Asthma Quality of Life Questionnaire ( AQLQ ) scores , and quantitative data describing website usage ( number of times logged on , length of time logged on , number of times individual pages looked at , and for how long ) .
METHODS	Secondary outcomes include clinical outcomes ( medication use , health services use , lung function ) and patient reported outcomes ( including adherence , patient activation measures , and health status ) .
CONCLUSIONS	Piloting of complex interventions is considered best practice and will maximise the potential of any future large-scale randomized controlled trial to successfully recruit and be able to report on necessary outcomes .
CONCLUSIONS	Here we will provide results across a range of outcomes which will provide estimates of efficacy to inform the design of a future full-scale randomized controlled trial of the ` Living well with asthma ' website .
BACKGROUND	This trial is registered with Current Controlled Trials ISRCTN78556552 on 18/06/13 .

###25451347
BACKGROUND	Arformoterol tartrate ( arformoterol , 15 g bid ) is a nebulized long-acting 2-agonist approved for maintenance treatment of COPD .
METHODS	This was a multicenter , double-blind , randomized , placebo-controlled study .
METHODS	Patients ( aged 40 years with baseline FEV1 65 % predicted , FEV1 > 0.50 L , FEV1/FVC 70 % , and 15 pack-year smoking history ) received arformoterol ( n = 420 ) or placebo ( n = 421 ) for 1 year .
METHODS	The primary assessment was time from randomization to respiratory death or first COPD exacerbation-related hospitalization .
RESULTS	Among 841 patients randomized , 103 had 1 primary event ( 9.5 % vs 15.0 % , for arformoterol vs placebo , respectively ) .
RESULTS	Patients who discontinued treatment for any reason ( 39.3 % vs 49.9 % , for arformoterol vs placebo , respectively ) were followed for up to 1 year postrandomization to assess for primary events .
RESULTS	Fewer patients receiving arformoterol than placebo experienced COPD exacerbation-related hospitalizations ( 9.0 % vs 14.3 % , respectively ) .
RESULTS	Twelve patients ( 2.9 % ) receiving arformoterol and 10 patients ( 2.4 % ) receiving placebo died during the study .
RESULTS	Risk for first respiratory serious adverse event was 50 % lower with arformoterol than placebo ( P = .003 ) .
RESULTS	Numerically more patients on arformoterol ( 13 ; 3.1 % ) than placebo ( 10 ; 2.4 % ) experienced cardiac serious adverse events ; however , time-to-first cardiac serious adverse event was not significantly different .
RESULTS	Improvements in trough FEV1 and FVC were greater with arformoterol ( least-squares mean change from baseline vs placebo : 0.051 L , P = .030 and 0.075 L , P = .018 , respectively ) .
RESULTS	Significant improvements in quality of life ( overall St. George 's Hospital Respiratory Questionnaire and Clinical COPD Questionnaire ) were observed with arformoterol vs placebo ( P < .05 ) .
CONCLUSIONS	Arformoterol demonstrated an approximately 40 % lower risk of respiratory death or COPD exacerbation-related hospitalization over 1 year vs placebo .
CONCLUSIONS	Arformoterol was well-tolerated and improved lung function vs placebo .
BACKGROUND	ClinicalTrials.gov ; No. : NCT00909779 ; URL : www.clinicaltrials.gov .

###25332468
BACKGROUND	Postexercise protein or amino acid ingestion restores muscle protein synthesis in older adults and represents an important therapeutic strategy for aging muscle .
BACKGROUND	However , the precise nutritional factors involved are unknown .
OBJECTIVE	The purpose of this study was to determine the role of increased postexercise Leu ingestion on skeletal muscle myofibrillar protein synthesis ( MyoPS ) , mammalian/mechanistic target of rapamycin complex 1 signaling , and amino acid transporter ( AAT ) mRNA expression in older men over a 24-h post-resistance exercise ( RE ) time course .
METHODS	During a stable isotope infusion trial ( l - [ ring - ( 13 ) C6 ] Phe ; l - [ 1 - ( 13 ) C ] Leu ) , older men performed RE and , at 1 h after exercise , ingested 10 g of essential amino acids ( EAAs ) containing either a Leu content similar to quality protein ( control , 1.85 g of Leu , n = 7 ) or enriched Leu ( LEU ; 3.5 g of Leu , n = 8 ) .
METHODS	Muscle biopsies ( vastus lateralis ) were obtained at rest and 2 , 5 , and 24 h after exercise .
RESULTS	p70 S6 kinase 1 phosphorylation was increased in each group at 2 h ( P < 0.05 ) , whereas 4E binding protein 1 phosphorylation increased only in the LEU group ( P < 0.05 ) .
RESULTS	MyoPS was similarly increased ( 90 % ) above basal in each group at 5 h ( P < 0.05 ) and remained elevated ( 90 % ) at 24 h only in the LEU group ( P < 0.05 ) .
RESULTS	The mRNA expression of select AATs was increased at 2 and 5 h in each group ( P < 0.05 ) , but AAT expression was increased at 24 h only in the LEU group ( P < 0.05 ) .
CONCLUSIONS	Leu-enriched EAA ingestion after RE may prolong the anabolic response and sensitivity of skeletal muscle to amino acids in older adults .
CONCLUSIONS	These data emphasize the potential importance of adequate postexercise Leu ingestion to enhance the response of aging muscle to preventive or therapeutic exercise-based rehabilitation programs .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT00891696 .

###24567620
BACKGROUND	Antibiotics are of limited overall clinical benefit for uncomplicated lower respiratory tract infection ( LRTI ) but there is uncertainty about their effectiveness for patients with features associated with higher levels of antibiotic prescribing .
OBJECTIVE	To estimate the benefits and harms of antibiotics for acute LRTI among those producing coloured sputum , smokers , those with fever or prior comorbidities , and longer duration of prior illness .
METHODS	Secondary analysis of a randomised controlled trial of antibiotic placebo for acute LRTI in primary care .
METHODS	Two thousand and sixty-one adults with acute LRTI , where pneumonia was not suspected clinically , were given amoxicillin or matching placebo .
METHODS	The duration of symptoms , rated moderately bad or worse ( primary outcome ) , symptom severity on days 2-4 ( 0-6 scale ) , and the development of new or worsening symptoms were analysed in pre-specified subgroups of interest .
METHODS	Evidence of differential treatment effectiveness was assessed in prespecified subgroups by interaction terms .
RESULTS	No subgroups were identified that were significantly more likely to benefit from antibiotics in terms of symptom duration or the development of new or worsening symptoms .
RESULTS	Those with a history of significant comorbidities experienced a significantly greater reduction in symptom severity between days 2 and 4 ( interaction term -0.28 , P = 0.003 ; estimated effect of antibiotics among those with a past history -0.28 [ 95 % confidence interval = -0.44 to -0.11 ] , P = 0.001 ) , equivalent to three people in 10 rating symptoms as a slight rather than a moderately bad problem .
RESULTS	For subgroups not specified in advance antibiotics provided a modest reduction in symptom severity for non-smokers and for those with short prior illness duration ( < 7 days ) , and a modest reduction in symptom duration for those with short prior illness duration .
CONCLUSIONS	There is no clear evidence of clinically meaningful benefit from antibiotics in the studied high-risk groups of patients presenting in general practice with uncomplicated LRTIs where prescribing is highest .
CONCLUSIONS	Any possible benefit must be balanced against the side-effects and longer-term effects on antibiotic resistance .

###24495468
BACKGROUND	Postural tachycardia syndrome ( POTS ) induces disabling chronic orthostatic intolerance with an excessive increase in heart rate ( HR ) upon standing , and many POTS patients have a hyperadrenergic state .
BACKGROUND	Medications that restrain HR are a promising approach to this problem .
OBJECTIVE	We tested the hypothesis that melatonin will attenuate the tachycardia and improve symptom burden in patients with POTS .
METHODS	Patients with POTS ( n = 78 ) underwent acute drug trials with melatonin 3 mg orally and placebo , on separate mornings , in a randomized crossover design .
METHODS	Blood pressure , HR , and symptoms were assessed while seated and after standing for up to 10 min prior to , and hourly for 4 h following study drug administration .
RESULTS	The reduction in standing HR was significantly greater 2 h after melatonin compared with placebo ( P = 0.017 ) .
RESULTS	There was no significant difference in the reduction of systolic blood pressure between melatonin and placebo , either with standing or while seated .
RESULTS	The symptom burden was not improved with melatonin compared with placebo .
CONCLUSIONS	Oral melatonin produced a modest decrease in standing tachycardia in POTS .
CONCLUSIONS	Further research is needed to determine the effects of regular night-time use of this medication in POTS .

###24668311
OBJECTIVE	Management of AO type B and C fractures of the distal radius is controversial .
OBJECTIVE	This study compares outcomes and complications of AO type B and C fractures of the distal radius treated with volar locked plating and nonoperative methods .
METHODS	Sixty-four patients with fractures of the distal radius ( AO type B and C ) were included in this study , according to inclusion criteria , and were allocated to the volar plating group or nonoperative group by alternate randomization : 32 patients with odd numbers went into the nonoperative group and the other 32 with even numbers went into the volar plating group .
METHODS	Patients in the nonoperative group were managed with closed reduction of the fracture and plaster cast application under an image intensifier .
METHODS	Those in the volar plating group were managed by open reduction and fixation with a volar locked plate .
METHODS	Preoperative and postoperative serial clinico-radiological follow-up was done .
METHODS	The range of movement , grip strength , functional outcome scores and radiological parameters were compared .
METHODS	Student 's t-test was used for statistical analysis with significance at p < 0.05 .
RESULTS	Range of movement and functional scores were significantly ( p < 0.001 ) better in the volar plating group , but the difference in ulnar variance and radial and ulnar deviation was insignificant as compared to the nonoperative group .
RESULTS	At 24 months follow-up , the nonoperative group had significantly more cases with malunion , articular incongruity and osteoarthritis .
CONCLUSIONS	In cases of AO type B or C fractures of the distal radius , volar locked plating provides anatomical stable fixation and early mobilization with better clinico-radiological outcome as compared to conservative treatment .

###25672179
BACKGROUND	Ingrown toe nail is common problem presenting to the surgeon .
BACKGROUND	Partial Nail avulsion only results in recurrence of the ingrown toe nail .
BACKGROUND	The aim of this study was too see the effect of phenolization in preventing recurrence after partial nail avulsion .
METHODS	This was a randomized controlled trial carried out at Department of Surgery , Pakistan Institute of Medical Sciences , Islamabad .
METHODS	This study included 100 patients ( 50 in each group ) with ingrown toe nail presented from November 2009 to October 2010 .
METHODS	This study compared the application of phenol after partial avulsion with partial avulsion alone in the treatment of ingrown toe nail .
RESULTS	Sixty-nine percent of the patients were males and 31 % were female .
RESULTS	The mean age in both groups was 18 years .
RESULTS	Patient in the partial nail avulsion with application of phenol group had less pain as compared to patient with partial nail avulsion group only .
RESULTS	Our study has shown that patient in phenol group had less post operative infection , spike formation and recurrence as compared to wedge resection group only .
CONCLUSIONS	Partial nail avulsion with phenolization is better than nartial nail avulsion only for the management of the in-growing toe nail .

###24842476
OBJECTIVE	A post-hoc analysis was performed to determine the relationship between the timing and magnitude of DAS28 ( ESR ) response and long term outcomes in Japanese patients after 1 year of CZP treatment .
METHODS	Our analysis included 82 J-RAPID trial patients treated with CZP 200 mg and methotrexate , and 116 HIKARI trial patients treated with CZP 200 mg alone or with disease-modifying agents other than methotrexate .
METHODS	Remission rates and changes in mTSS at year 1 were compared to the DAS28 ( ESR ) response at week 12 of CZP treatment .
RESULTS	After 1 year of treatment , remission was achieved in 41.3 % of the J-RAPID and 34.9 % of the HIKARI patients with a week 12 DAS28 ( ESR ) response of 1.2 .
RESULTS	In comparison , patients with a DAS28 ( ESR ) response of < 1.2 at week 12 only had a < 7 % probability of achieving remission and displayed higher change in mTSS after 1-year treatment .
CONCLUSIONS	The likelihood of remission and extent of radiographic progression after 1 year was associated with the week 12 DAS28 ( ESR ) response .
CONCLUSIONS	The DAS28 ( ESR ) response at 12 weeks could be beneficial for identifying patients that are unlikely to respond to prolonged CZP treatment .

###24739452
BACKGROUND	The likelihood of an adolescent taking up smoking may be influenced by his or her society , school and family .
BACKGROUND	Thus , changes in the immediate environment may alter a young person 's perception of smoking .
METHODS	The proposed multi-center , cluster-randomized controlled trial will be stratified by the baseline prevalence of smoking in schools .
METHODS	Municipalities with fewer than 100,000 inhabitants will be randomly assigned to a control or intervention group .
METHODS	One secondary school will be randomly selected from each municipality .
METHODS	These schools will be randomized to two groups : the students of one will receive any existing educational course regarding smoking , while those of the other school will receive a four-year , class-based curriculum intervention ( 22 classroom lessons ) aimed at reinforcing a smoke-free school policy and encouraging smoking cessation in parents , pupils , and teachers .
METHODS	The intervention will also include annual meetings with parents and efforts to empower adolescents to change the smoking-related attitudes and behaviors in their homes , classrooms and communities.We will enroll children aged 12-13 years as they enter secondary school during two consecutive school years ( to obtain sufficient enrolled subjects ) .
METHODS	We will follow them for five years , until two years after they leave secondary school .
METHODS	All external evaluators and analysts will be blinded to school allocation.The aim of this study is to analyze the effectiveness of a complex intervention in reducing the prevalence of smoking in the third year of compulsory secondary education ( ESO ) and two years after secondary school , when the participants are 14-15 and 17-18 years old , respectively .
CONCLUSIONS	Most interventions aimed at preventing smoking among adolescents yield little to no positive long-term effects .
CONCLUSIONS	This clinical trial will analyze the effectiveness of a complex intervention aimed at reducing the incidence and prevalence of smoking in this vulnerable age group .
BACKGROUND	Current Controlled Trials : NCT01602796 .

###25310007
BACKGROUND	Although evidence exists for the effectiveness of web-based smoking cessation interventions , information about the cost-effectiveness of these interventions is limited .
OBJECTIVE	The study investigated the cost-effectiveness and cost-utility of two web-based computer-tailored ( CT ) smoking cessation interventions ( video - vs. text-based CT ) compared to a control condition that received general text-based advice .
METHODS	In a randomized controlled trial , respondents were allocated to the video-based condition ( N = 670 ) , the text-based condition ( N = 708 ) or the control condition ( N = 721 ) .
METHODS	Societal costs , smoking status , and quality-adjusted life years ( QALYs ; EQ-5D-3L ) were assessed at baseline , six-and twelve-month follow-up .
METHODS	The incremental costs per abstinent respondent and per QALYs gained were calculated .
METHODS	To account for uncertainty , bootstrapping techniques and sensitivity analyses were carried out .
RESULTS	No significant differences were found in the three conditions regarding demographics , baseline values of outcomes and societal costs over the three months prior to baseline .
RESULTS	Analyses using prolonged abstinence as outcome measure indicated that from a willingness to pay of 1,500 , the video-based intervention was likely to be the most cost-effective treatment , whereas from a willingness to pay of 50,400 , the text-based intervention was likely to be the most cost-effective .
RESULTS	With regard to cost-utilities , when quality of life was used as outcome measure , the control condition had the highest probability of being the most preferable treatment .
RESULTS	Sensitivity analyses yielded comparable results .
CONCLUSIONS	The video-based CT smoking cessation intervention was the most cost-effective treatment for smoking abstinence after twelve months , varying the willingness to pay per abstinent respondent from 0 up to 80,000 .
CONCLUSIONS	With regard to cost-utility , the control condition seemed to be the most preferable treatment .
CONCLUSIONS	Probably , more time will be required to assess changes in quality of life .
CONCLUSIONS	Future studies with longer follow-up periods are needed to investigate whether cost-utility results regarding quality of life may change in the long run .
BACKGROUND	Nederlands Trial Register NTR3102 .

###24856433
OBJECTIVE	To compare the effects of two maternal feeding policies-early versus conventional oral feeding-after cesarean delivery .
METHODS	This prospective multicenter randomized comparative trial was conducted at tertiary care hospitals in Sindh , Pakistan , from 2010 to 2012 .
METHODS	Women with an uncomplicated cesarean delivery under spinal anesthesia were allocated to an intervention of early ( after 2 hours ) or conventional ( after 18 hours ) initiation of oral feeding .
METHODS	Outcomes included maternal ambulation , maternal satisfaction , gastrointestinal functions , and length of hospital stay .
RESULTS	In total , 1174 women ( n = 587 per group ) were included in the final analysis .
RESULTS	Gastrointestinal complications were not significantly different between the two groups .
RESULTS	Lower intensities of thirst and hunger and a higher rate of maternal satisfaction were observed in the early feeding group ( P < 0.05 ) , and 53.8 % of women in this group were able to ambulate within 15 hours of surgery , compared with 27.9 % of women in the conventional feeding group .
RESULTS	The frequencies of readmission , febrile morbidity , and wound infection were insignificant .
CONCLUSIONS	Early oral dietary initiation after cesarean delivery resulted in early ambulation , greater maternal satisfaction , and reduced length of hospital stay , with no detrimental outcomes , making this practice cost-effective .
CONCLUSIONS	Hence , day-care cesarean delivery might be an option in resource-constrained settings .
BACKGROUND	ChiCTR-TRC-13003651 , http://www.chictr.org .

###24462108
BACKGROUND	There is lack of well-designed trials evaluating structural benefits of non-pharmacologic therapies in knee osteoarthritis ( OA ) .
BACKGROUND	In this parallel-group randomized controlled trial , we aim to compare the possible advantages of lateral wedge insole and acupuncture in patients with medial knee OA .
METHODS	Patients with grade two or three of medial knee OA were randomly allocated to group one who received an in shoe lateral wedge and group two who underwent acupuncture .
METHODS	We assessed patients ' pain , function and knee joint cartilage thickness before and after intervention .
METHODS	Paired t-test and independent samples t-test were used for in group and between group analyses .
METHODS	2 . )
RESULTS	Twenty patients in each group were recruited in the study .
RESULTS	Pain significantly decreased after therapy in both groups one and two ( paired t test , P < 0.001 , 95 % CI : 1.62-3 .25 and 1.58-3 .20 respectively ) .
RESULTS	Function improved in each group ( paired t test , P = 0.001 , 95 % CI of 0.94-2 .38 in group one and 0.97-2 .43 in group two ) .
RESULTS	A non-clinically statistically significant difference regarding the femoral and tibial cartilage thickness was obtained in both groups one ( P = 0.005 , CI : -0.43 -0.82 and P = 0.037 , CI : -0.44 -0.80 respectively ) and two ( P = 0.025 , CI : -0.45 -0.79 and P = 0.035 , CI : -0.29 -0.96 respectively ) .
RESULTS	Between groups analysis showed no significant difference regarding abovementioned measures .
CONCLUSIONS	Both lateral wedge insole and acupuncture can be effective in the treatment of medial knee osteoarthritis without any superiority of one over the other .
CONCLUSIONS	Iranian Registry of Clinical Trials : IRCT201201108235N1 .
CONCLUSIONS	URL : http://irct.ir/searchen.php .

###26200180
BACKGROUND	Glucose-insulin-potassium ( GIK ) administration during cardiac surgery inconsistently improves myocardial function , perhaps because hyperglycemia negates the beneficial effects of GIK .
BACKGROUND	The hyperinsulinemic normoglycemic clamp ( HNC ) technique may better enhance the myocardial benefits of GIK .
BACKGROUND	The authors extended previous GIK investigations by ( 1 ) targeting normoglycemia while administering a GIK infusion ( HNC ) ; ( 2 ) using improved echocardiographic measures of myocardial deformation , specifically myocardial longitudinal strain and strain rate ; and ( 3 ) assessing the activation of glucose metabolic pathways .
METHODS	A total of 100 patients having aortic valve replacement for aortic stenosis were randomly assigned to HNC ( high-dose insulin with concomitant glucose infusion titrated to normoglycemia ) versus standard therapy ( insulin treatment if glucose > 150mg/dl ) .
METHODS	The primary outcomes were left ventricular longitudinal strain and strain rate , assessed using speckle-tracking echocardiography .
METHODS	Right atrial tissue was analyzed for activation of glycolysis/pyruvate oxidation and alternative metabolic pathways .
RESULTS	Time-weighted mean glucose concentrations were lower with HNC ( 12719mg/dl ) than standard care ( 17741mg/dl ; P < 0.001 ) .
RESULTS	Echocardiographic data were adequate in 72 patients for strain analysis and 67 patients for strain rate analysis .
RESULTS	HNC did not improve myocardial strain , with an HNC minus standard therapy difference of -1.2 % ( 97.5 % CI , -2.9 to 0.5 % ; P = 0.11 ) .
RESULTS	Strain rate was significantly better , but by a clinically unimportant amount : -0.16 s ( -0.30 to -0.03 s ; P = 0.007 ) .
RESULTS	There was no evidence of increased glycolytic , pyruvate oxidation , or hexosamine biosynthetic pathway activation in right atrial samples ( HNC , n = 20 ; standard therapy , 22 ) .
CONCLUSIONS	Administration of glucose and insulin while targeting normoglycemia during aortic valve replacement did not meaningfully improve myocardial function .

###25886286
BACKGROUND	Infectious illnesses such as influenza and diarrhea are leading causes of absenteeism among Danish school children .
BACKGROUND	Interventions in school settings addressing hand hygiene have shown to reduce the number of infectious illnesses .
BACKGROUND	However , most of these studies include small populations and almost none of them are conducted as randomized controlled trials .
BACKGROUND	The overall aim of the Hi Five study was to develop , implement and evaluate a multi-component school-based intervention to improve hand hygiene and well-being and to reduce the prevalence of infections among school children in intervention schools by 20 % compared to control schools .
BACKGROUND	This paper describes the development and the evaluation design of Hi Five .
METHODS	The Hi Five study was designed as a tree-armed cluster-randomized controlled trial .
METHODS	A national random sample of schools ( n = 44 ) was randomized to one of two intervention groups ( n = 29 ) or to a control group with no intervention ( n = 15 ) .
METHODS	A total of 8,438 six to fifteen-year-old school children were enrolled in the study .
METHODS	The Hi Five intervention consisted of three components : 1 ) a curriculum component 2 ) mandatory daily hand washing before lunch 3 ) extra cleaning of school toilets during the school day .
METHODS	Baseline data was collected from December 2011 to April 2012 .
METHODS	The intervention period was August 2012 to June 2013 .
METHODS	The follow-up data was collected from December 2012 to April 2013 .
CONCLUSIONS	The Hi Five study fills a gap in international research .
CONCLUSIONS	This large randomized multi-component school-based hand hygiene intervention is the first to include education on healthy and appropriate toilet behavior as part of the curriculum .
CONCLUSIONS	No previous studies have involved supplementary cleaning at the school toilets as an intervention component .
CONCLUSIONS	The study will have the added value of providing new knowledge about usability of short message service ( SMS , text message ) for collecting data on infectious illness and absenteeism in large study populations .
BACKGROUND	Current Controlled Trials ISRCTN19287682 , 21 December 2012 .

###25727713
BACKGROUND	Bacterial screening offers the possibility of extending platelet ( PLT ) storage to Day 7 .
BACKGROUND	We conducted a noninferiority , crossover trial comparing PLTs stored for 6 or 7 days versus 2 to 5 days .
METHODS	Stable hematology patients were allocated to receive blocks of 2 - to 5 - and 6 - or 7-day PLTs in random order .
METHODS	The primary outcome was the proportion of successful transfusions during the first block , defined as a corrected count increment ( CCI ) of more than 4.5 at 8 to 24 hours posttransfusion .
RESULTS	Of 122 patients with an evaluable first block , 87 ( 71 % ) and 84 ( 69 % ) had successful transfusions after 2 - to 5 - and 6 - or 7-day PLTs of mean ( SD ) ages of 3.8 ( 1.0 ) and 6.4 ( 0.5 ) days , respectively .
RESULTS	Six - or 7-day PLTs were declared noninferior to 2 - to 5-day PLTs since the upper confidence interval ( CI ) limit was less than the predefined noninferiority margin of 10 % ( 95 % CI , -14.0 % to 9.1 % ; p = 0.766 ) .
RESULTS	Logistic regression analysis gave an adjusted odds ratio of 0.86 ( 95 % CI , 0.47-1 .58 ; p = 0.625 ) .
RESULTS	Mean ( SD ) 8 - to 24-hour CCIs were 9.4 ( 7.9 ) and 7.7 ( 7.1 ) after transfusion with 2 - to 5 - or 6 - or 7-day PLTs ( 95 % CI , -3.31 to 0.03 ; p = 0.054 ) .
RESULTS	The proportions of days with bleeding scores of WHO Grade 2 or higher were 13 % ( 38/297 days ) and 11 % ( 32/296 days ; 95 % CI , -3.2 to 7.2 ; p = 0.454 ) .
RESULTS	Median interval to next PLT transfusion ( 2 days ) was unaffected ( 95 % CI , -10.5 to 5.4 ; p = 0.531 ) .
CONCLUSIONS	In hematology patients , there was no evidence that 6 - or 7-day PLTs were inferior to 2 - to 5-day PLTs , as measured by proportion of patients with successful transfusions , bleeding events , or interval to next transfusion .

###24223416
OBJECTIVE	To evaluate the effect of the resin cement thickness ( RCT ) on bond strength ( BS ) and gap formation ( GF ) of fiber posts bonded to root dentin .
METHODS	The roots of 24 extracted human mandibular premolars were treated endodontically and the post spaces were prepared using drills with different diameters according to the following groups ( n = 8 ) : well adapted ( WA ) , moderately well adapted ( MA ) and poorly adapted ( PA ) .
METHODS	The fiber glass posts were cemented ( Excite DSC and Variolink II ) in accordance with the manufacturer 's instructions .
METHODS	After 1 week , the roots were transversely sectioned into six 1-mm-thick disks and photographed using an optical microscope to determine the RCT .
METHODS	After this , epoxy resin replicas of each sample were observed using SEM , and the mean length and width of the gaps formed in the cement/dentin/post interface were measured .
METHODS	Finally , each sample was subjected to the push-out test ( 0.5 mm/min ) , and the data were statistically analyzed using one-way ANOVA and Tukey 's tests at the 5 % level of significance .
RESULTS	The lowest RCT ( m ) was observed for WA and the highest for PA. .
RESULTS	The group MA showed an intermediate value .
RESULTS	Significantly higher push-out BS values were observed for WA compared to the other groups .
RESULTS	The MA and PA groups were statistically similar .
RESULTS	The highest mean gap length ( % ) and width ( m ) were observed for PA. .
RESULTS	The groups MA and WA were statistically similar .
CONCLUSIONS	Lower resin cement thickness resulted in better fiber post adhesion , that is , in higher bond strength and less gap formation .

###25372086
BACKGROUND	We assessed the effects of reduction and withdrawal of treatment in patients with rheumatoid arthritis who had a remission while receiving etanercept-plus-methotrexate therapy .
METHODS	Patients with early active disease who had not previously received methotrexate or biologic therapy received 50 mg of etanercept plus methotrexate weekly for 52 weeks ( open-label phase ) .
METHODS	We then randomly assigned patients who had qualifying responses at weeks 39 and 52 to receive 25 mg of etanercept plus methotrexate ( combination-therapy group ) , methotrexate alone , or placebo for 39 weeks ( double-blind phase ) .
METHODS	Patients who had qualifying responses at week 39 of the double-blind phase had all treatment withdrawn at that time and were followed to week 65 ( treatment-withdrawal phase ) .
METHODS	The primary end point was the proportion of patients with sustained remission in the double-blind phase .
RESULTS	Of 306 patients enrolled , 193 underwent randomization in the double-blind phase ; 131 qualified for the treatment-withdrawal phase .
RESULTS	More patients in the combination-therapy group than in the methotrexate-alone group or the placebo group met the criterion for the primary end point ( 40 of 63 [ 63 % ] vs. 26 of 65 [ 40 % ] and 15 of 65 [ 23 % ] , respectively ; P = 0.009 for combination therapy vs. methotrexate alone ; P < 0.001 for combination therapy vs. placebo ) .
RESULTS	At 65 weeks , 28 patients ( 44 % ) who had received combination therapy , 19 ( 29 % ) who had received methotrexate alone , and 15 ( 23 % ) who had received placebo were in remission ( P = 0.10 for combination therapy vs. methotrexate alone ; P = 0.02 for combination therapy vs. placebo ; P = 0.55 for methotrexate alone vs. placebo ) .
RESULTS	No significant between-group differences were observed in radiographic progression of disease .
RESULTS	Serious adverse events were reported in 3 patients ( 5 % ) in the combination-therapy group , 2 ( 3 % ) in the methotrexate-alone group , and 2 ( 3 % ) in the placebo group .
CONCLUSIONS	In patients with early rheumatoid arthritis who had a remission while receiving full-dose etanercept-plus-methotrexate therapy , continuing combination therapy at a reduced dose resulted in better disease control than switching to methotrexate alone or placebo , but no significant difference was observed in radiographic progression .
CONCLUSIONS	( Funded by Pfizer ; ClinicalTrials.gov number , NCT00913458 . )

###24993098
BACKGROUND	Heart failure with reduced ejection fraction and obstructive sleep apnea ( OSA ) , 2 states of increased metabolic demand and sympathetic nervous system activation , often coexist .
BACKGROUND	Continuous positive airway pressure ( CPAP ) , which alleviates OSA , can improve ventricular function .
BACKGROUND	It is unknown whether this is due to altered oxidative metabolism or presynaptic sympathetic nerve function .
BACKGROUND	We hypothesized that short-term ( 6-8 weeks ) CPAP in patients with OSA and heart failure with reduced ejection fraction would improve myocardial sympathetic nerve function and energetics .
RESULTS	Forty-five patients with OSA and heart failure with reduced ejection fraction ( left ventricular ejection fraction 35.89.7 % [ meanSD ] ) were evaluated with the use of echocardiography and 11C-acetate and 11C-hydroxyephedrine positron emission tomography before and 6 to 8 weeks after randomization to receive short-term CPAP ( n = 22 ) or no CPAP ( n = 23 ) .
RESULTS	Work metabolic index , an estimate of myocardial efficiency , was calculated as follows : ( stroke volume indexheart ratesystolic blood pressureKmono ) , where Kmono is the monoexponential function fit to the myocardial 11C-acetate time-activity data , reflecting oxidative metabolism .
RESULTS	Presynaptic sympathetic nerve function was measured with the use of the 11C-hydroxyephedrine retention index .
RESULTS	CPAP significantly increased hydroxyephedrine retention versus no CPAP ( retention : +0.012 [ 0.002 , 0.021 ] versus -0.006 [ -0.013 , 0.005 ] min ( -1 ) ; P = 0.003 ) .
RESULTS	There was no significant change in work metabolic index between groups .
RESULTS	However , in those with more severe OSA ( apnea-hypopnea index > 20 events per hour ) , CPAP significantly increased both work metabolic index and systolic blood pressure ( P < 0.05 ) .
CONCLUSIONS	In patients with heart failure with reduced ejection fraction and OSA , short-term CPAP increased hydroxyephedrine retention , indicating improved myocardial sympathetic nerve function , but overall did not affect energetics .
CONCLUSIONS	In those with more severe OSA , CPAP may improve cardiac efficiency .
CONCLUSIONS	Further outcome-based investigation of the consequences of CPAP is warranted .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00756366 .

###25163019
BACKGROUND	We performed a pilot study examining the safety and tolerability of valacyclovir in veterans with herpes simplex virus type 2 and hepatitis C virus ( HCV ) coinfection .
METHODS	We performed a randomized double-blind , placebo-controlled , crossover clinical trial in U.S. veterans with genotype 1 HCV/herpes simplex virus type 2 coinfection .
METHODS	Patients were randomized 1:1 in blocks of 10 to receive either 1 g twice-daily valacyclovir or matching placebo for 8 weeks followed by a 2-week washout phase with daily placebo .
METHODS	The alternate therapy ( valacyclovir or placebo ) was given for an additional 8-week period .
METHODS	Safety assessments were performed every 2 weeks .
METHODS	Changes in HCV RNA and alanine aminotransferase ( ALT ) were estimated using linear mixed models ( SAS Proc Mixed ) .
RESULTS	Thirty patients were enrolled .
RESULTS	Valacyclovir was not associated with toxicity or adverse events .
RESULTS	ALT levels declined 6 % to 10 % ; mean HCV RNA levels were reduced 24 % ( 1.3 million IU/mL [ 0.21 log10 IU/mL ] ) during the valacyclovir phase ( P = 0.08 ) with no carryover effect observed ( P = 0.21 ) .
CONCLUSIONS	Valacyclovir 1 g twice daily showed no evidence of hepatotoxicity in U.S. veterans with hepatitis C.
CONCLUSIONS	A modest reduction in serum levels of ALT and plasma levels of HCV RNA was observed .

###25342290
OBJECTIVE	Leucovorin is commonly used as folate supplement in 5-fluorouracil-based chemotherapy , but needs to be converted to active 5,10-methylenetetrahydrofolate ( methyleneTHF ) intracellularly .
OBJECTIVE	This provides for interindividual differences .
OBJECTIVE	MethyleneTHF has recently been developed into the stable , distributable drug , Modufolin .
OBJECTIVE	The aim was to compare the concentration of folate metabolites in tumor , mucosa , and plasma of patients with colon cancer after administration of Modufolin or Isovorin ( levo-leucovorin ) .
METHODS	Thirty-two patients scheduled for colon resection were randomized to receive Modufolin or Isovorin at dosage of 60 or 200 mg/m .
METHODS	The study drug was given as one i.v. bolus injection after anesthesia .
METHODS	Plasma was collected for pharmacokinetic ( PK ) analysis before , during , and after surgery .
METHODS	Tissue biopsies were collected at surgery .
METHODS	Folate metabolites were analyzed by LC-MS/MS .
RESULTS	MethyleneTHF and THF concentrations were significantly higher in mucosa ( p < 0.01 , both dosages ) and tumors ( p < 0.01 , 200 mg/m ) after Modufolin as compared to Isovorin administration .
RESULTS	The results correlated with PK observations .
RESULTS	The Modufolin to Isovorin C ( max ) ratio for methyleneTHF was 113 at 200 mg/m and 52 at 60 mg/m ; the AUC ( last ) ratios were 17 and 9 , respectively .
RESULTS	The THF plasma concentrations were also higher after Modufolin administration ( C ( max ) ratio 23 , AUC ( last ) ratio 13 at 200 mg/m ; C ( max ) ratio 15 , AUC ( last ) ratio 11 at 60 mg/m ) .
CONCLUSIONS	Modufolin administration resulted in significantly higher methyleneTHF levels than Isovorin and may potentially increase the efficacy of 5-fluorouracil-based chemotherapy .
CONCLUSIONS	The results encourage further evaluation of Modufolin as a substitute to Isovorin including the potential clinical benefits .

###24352403
BACKGROUND	Therapy guided by N-terminal-pro-B-type natriuretic peptide ( NT-proBNP ) levels may improve outcomes in patients with chronic heart failure ( HF ) , especially in younger patients with reduced left ventricular ejection fraction .
BACKGROUND	It remains unclear whether treatment effects persist after discontinuation of the NT-proBNP-guided treatment strategy .
RESULTS	Trial of Intensified versus standard Medical therapy in Elderly patients with Congestive Heart Failure randomized 499 patients with HF aged60 years with left ventricular ejection fraction45 % to intensified , NT-proBNP-guided versus standard , symptom-guided therapy into prespecified age groups ( 60-74 and 75 years ) during 18 months .
RESULTS	A total of 329 patients ( 92 % ) alive at 18 months agreed to long-term follow-up .
RESULTS	HF medication was intensified to a larger extent in the NT-proBNP-guided group .
RESULTS	During long-term , NT-proBNP-guided therapy did not improve hospital-free ( primary end point : hazard ratio , 0.87 ; 95 % confidence interval , 0.71-1 .06 ; P = 0.16 ) or overall survival ( hazard ratio , 0.85 ; 95 % confidence interval , 0.64-1 .13 ; P = 0.25 ) but did improve HF hospitalization-free survival ( hazard ratio , 0.70 ; 95 % confidence interval , 0.55-0 .90 ; P = 0.005 ) .
RESULTS	Patients aged 60 to 74 years had benefit from NT-proBNP-guided therapy on the primary end point and HF hospitalization-free survival , whereas patients aged75 years did not ( P < 0.10 for interaction ) .
RESULTS	In landmark analysis , there was no regression to the mean after cessation of the NT-proBNP-guided strategy .
RESULTS	More intensified HF medication at month 12 was associated with better long-term HF hospitalization-free and overall survival .
CONCLUSIONS	Intensified , NT-proBNP-guided therapy did not improve the primary end point compared with symptom-guided therapy but did improve HF hospitalization-free survival .
CONCLUSIONS	Within the subgroup of patients aged 60 to 74 years , it improved clinical outcome including the primary end point .
CONCLUSIONS	These effects did not disappear after cessation of the NT-proBNP-guided strategy on the long-term .
CONCLUSIONS	This is possibly attributable to a more intensified HF medical therapy in the NT-proBNP-guided group .
BACKGROUND	URL : http://www.isrctn.org .
BACKGROUND	Unique identifier : ISRCTN43596477 .

###25926507
BACKGROUND	Probiotics can modulate the immune system in healthy individuals and may help reduce symptoms related to respiratory infections .
OBJECTIVE	The objective of the study was to investigate the effect of the probiotic strain Lactobacillus paracasei subsp .
OBJECTIVE	paracasei , L. casei 431 ( Chr .
OBJECTIVE	Hansen A/S ) ( hereafter , L. casei 431 ) on immune response to influenza vaccination and respiratory symptoms in healthy adults .
METHODS	A randomized double-blind , placebo-controlled trial was conducted in 1104 healthy subjects aged 18-60 y at 2 centers in Germany and Denmark .
METHODS	Subjects were randomly assigned to receive an acidified milk drink containing 10 ( 9 ) colony-forming units of L. casei 431 ( n = 553 ) or placebo ( n = 551 ) for 42 d.
METHODS	After 21 d , subjects received the seasonal influenza vaccination .
METHODS	The primary outcome was seroprotection rate ( anti-influenza antibody titers by hemagglutination inhibition ) 21 d after vaccination .
METHODS	Other outcomes were seroconversion rate and mean titers , influenza A-specific antibodies and incidence , and duration and severity of upper respiratory symptoms .
METHODS	Antibiotic use and use of health care resources were recorded .
RESULTS	There was no effect of L. casei 431 on immune responses to influenza vaccination .
RESULTS	Generalized linear mixed modeling showed a shorter duration of upper respiratory symptoms in the probiotic group than in the placebo group ( mean SD : 6.4 6.1 vs. 7.3 9.7 d , P = 0.0059 ) in the last 3 wk of the intervention period .
RESULTS	No statistically significant differences were found for incidence or severity .
CONCLUSIONS	Daily consumption of L. casei 431 resulted in no observable effect on the components of the immune response to influenza vaccination but reduced the duration of upper respiratory symptoms .
CONCLUSIONS	The trial was registered at www.isrctn.com as ISRCTN08280229 .

###25384624
OBJECTIVE	Influenza vaccination is recommended for inflammatory bowel disease ( IBD ) patients on immunosuppressive therapy .
OBJECTIVE	The objective was to evaluate the antibody and cell-mediated immune response to the split and whole virion influenza vaccine in patients with IBD treated with anti-TNF - and immunosuppressive therapy .
METHODS	One hundred and fifty-six immunocompromised IBD patients were vaccinated .
METHODS	Fifty-three patients ( control group ) refused vaccination .
METHODS	Split virion vaccine and whole virion vaccine were used .
METHODS	Serum samples were obtained for pre - and postimmunization antibody titers to influenza vaccine ( A/California/7 / 2009 [ H1N1 ] , A/Victoria/361 / 2011 [ H3N2 ] , B/Wisconsin/1 / 2010-like B/Hubei-Wujiagang/158 / 2009 ) .
METHODS	Cell-mediated response was evaluated using an interferon ( INF ) - , interleukine ( IL ) -2 and tumor necrosis factor ( TNF ) - ELISA .
RESULTS	Postimmunization titers of both influenza subtypes increased significantly after the administration of split virion vaccines compared to the controls and to those who received whole virion vaccine .
RESULTS	The antibody titers of Influenza B also increased significantly in patients immunized with split vaccine and treated with anti-TNF - therapy .
RESULTS	After influenza vaccination , the level of serum IL-2 significantly decreased .
RESULTS	No serious side effects developed occurred after influenza vaccination , and the influenza-like symptoms did not differ significantly between vaccinated versus control patients .
RESULTS	The relapse of the disease was observed in only 10 % of the patients and was more common in vaccinated than in control subjects .
CONCLUSIONS	Split virion vaccines seem to be more effective than whole virion vaccines .
CONCLUSIONS	Measuring the antibody responses is worthwhile in patients treated with immunosuppressants to determine the efficacy of influenza vaccination .

###24355210
BACKGROUND	Bevacizumab improves outcome for patients with advanced colorectal cancer ( CRC ) when added to chemotherapy .
BACKGROUND	The HORIZON I trial resulted in similar outcome with bevacizumab or cediranib , a small-molecule tyrosine kinase inhibitor of vascular endothelial growth factor ( VEGF ) receptor , as treatment of advanced CRC .
BACKGROUND	The spectrum of lactate dehydrogenase ( LDH ) isoenzyme expression was examined in serum samples of HORIZON I participants to identify biomarkers predictive of efficacy of VEGF pathway inhibitors .
METHODS	Total LDH levels , as well as LDH isoenzyme levels in frozen baseline serum samples , were retrospectively evaluated .
METHODS	Total LDH serum levels measured during the study , progression-free survival ( PFS ) , and overall survival ( OS ) were available from the HORIZON I study data .
RESULTS	Total LDH levels measured in the frozen serum samples correlated with those measured in fresh samples .
RESULTS	The expected reciprocal correlation was found between hypoxic and oxic LDH isoenzymes .
RESULTS	High total LDH correlated with shorter PFS , and high hypoxia-related LDH isoenzymes correlated with shorter PFS and OS .
RESULTS	The difference in outcome of the cediranib-treated patients vs. those treated with bevacizumab was not substantially different in the various LDH isoform expression subgroups .
RESULTS	In patients with a hypoxic LDH pattern of expression , there was a nonsignificant trend of better outcome in cediranib-treated patients .
CONCLUSIONS	Evaluation of total LDH and its isoforms in frozen serum samples is feasible .
CONCLUSIONS	High total LDH and high hypoxic LDH isoenzymes were associated with poor prognosis .
CONCLUSIONS	Further studies are needed to evaluate the predictive value of LDH isoenzyme expression pattern for VEGF-pathway inhibition efficacy .

###24322805
OBJECTIVE	The aim of this study was to evaluate the clinical outcomes of intrastromal MyoRing ( Dioptex , GmbH , Linz , Austria ) implantation at 2 different depths of 250 and 300 m.
METHODS	This was a prospective interventional randomized controlled trial , a pilot study .
METHODS	Keratoconic patients with keratometry values between 48 and 52 diopters were randomly divided into 2 groups .
METHODS	A continuous intrastromal corneal ring of the same size was implanted at 2 different stromal depths of 250 m ( group 1 ) and 300 m ( group 2 ) using femtosecond laser technology for both groups .
METHODS	Visual and refractive outcomes , keratometry , corneal biomechanical characteristics , and higher order aberrations were compared at the 1-year postoperative follow-up .
RESULTS	In both groups , uncorrected distance visual acuity significantly improved after MyoRing implantation , whereas neither of these showed any improvement in the corrected distance visual acuity .
RESULTS	In addition , the mean central keratometry and spherical and cylindrical refraction reduced significantly in both groups , and spherical aberration increased significantly in both groups .
RESULTS	On one hand , coma was reduced almost significantly in both groups , and on the other hand , corneal hysteresis and corneal resistance factor did not change significantly after the operation .
RESULTS	None of the patients in both groups had intraoperative or postoperative complications .
RESULTS	There were no differences observed in any of the measured variables of the 2 study groups .
CONCLUSIONS	An implantation depth of 250 m has comparable outcomes with the previously applied 300-m implantation depth .
CONCLUSIONS	It may be appropriate for selected cases of keratoconus with lower pachymetry .

###24827128
BACKGROUND	Taxane-based adjuvant chemotherapy is standard in node-positive ( N + ) early breast cancer ( BC ) .
BACKGROUND	The magnitude of benefit in intermediate-risk N + early BC is still unclear .
BACKGROUND	WSG-AGO epiribicine and cyclophosphamide ( EC ) - Doc is a large trial evaluating modern taxane-based chemotherapy in patients with 1-3 positive lymph nodes ( LNs ) only .
METHODS	A total of 2011 BC patients ( 18-65 years , pN1 ) were entered into a randomized phase III trial comparing 4 E90C600 q3w followed by 4 docetaxel 100 q3w ( n = 1008 ) with the current standard : 6 F500E100C500 q3w ( n = 828 ) or C600M40F600 d1 , 8 q4w ( n = 175 ) .
METHODS	Primary end point was event-free survival ( EFS ) ; secondary end points were overall survival ( OS ) , toxicity , translational research , and quality of life .
METHODS	Central tumor bank samples were evaluable in a representative collective ( n = 772 ; 40 % ) .
METHODS	Ki-67 was assessed centrally in hormone receptor-positive disease as a surrogate marker for the distinction of luminal A/B-like tumors .
RESULTS	Baseline characteristics were well balanced between study arms in both main study and central tumor bank subset .
RESULTS	At 59-month median follow-up , superior efficacy of EC-Doc [ versus FEC ( a combination of 5-fluorouracil , epirubicin , and cyclophosphamide ) ] was seen in EFS and OS : 5-year EFS : 89.8 % versus 87.3 % ( P = 0.038 ) ; 5-year OS : 94.5 % versus 92.8 % ( P = 0.034 ) ; both tests one-tailed .
RESULTS	EC-Doc caused more toxicity .
RESULTS	In hormone receptor-positive ( HR ) + disease , only high-Ki-67 tumors ( 20 % ) derived significant benefit from taxane-based therapy : hazard ratio = 0.39 ( 95 % CI 0.18-0 .82 ) for EC-Doc versus FEC ( test for interaction ; P = 0.01 ) .
CONCLUSIONS	EC-Doc significantly improved EFS and OS versus FEC in intermediate-risk BC ( 1-3 LNs ) within all subgroups as defined by local pathology .
CONCLUSIONS	In HR + disease , patients with luminal A-like tumors may be potentially over-treated by taxane-based chemotherapy .
BACKGROUND	ClinicalTrials.gov , NCT02115204 .

###24714349
OBJECTIVE	To clarify whether the results of repair of a complex mitral lesion ( Barlow valve ) at the intermediate-term follow-up are independent of the mode of surgical access [ minithoracotomy vs. median sternotomy ( MS ) ] .
METHODS	In a prospective randomized study of mitral repair for Barlow disease using either a minimally invasive ( MI ) approach or MS , we achieved an average follow-up of 3 years ( echocardiography , physical examination and quality of life ) .
METHODS	Mitral repair was achieved with polytetrafluoroethylene chordal implantation for both leaflets .
RESULTS	Both groups included 80 patients .
RESULTS	Mechanical ventilation time and intensive care unit and hospital stay were shorter in the MI group ( p = 0.01 , p = 0.013 and p = 0.02 , respectively ) .
RESULTS	During the follow-up , 5 patients in each group ( 6.25 % ) displayed mild mitral regurgitation , while 2 patients in each group ( 2.5 % ) developed recurrent regurgitation graded as at least moderate/severe .
RESULTS	The rate of mitral reoperation was 2.5 % in the MI group and 1.25 % in the MS group ( p = 0.9 ) .
RESULTS	The overall follow-up mortality was 3.75 % in both the MI and the MS groups .
CONCLUSIONS	The 3-year results of repair of Barlow valves were satisfactory irrespective of the approach used to repair the valve .
CONCLUSIONS	The advantages of MI surgery can be achieved in patients with mitral Barlow disease without concerns over the durability of repair .

###24517062
OBJECTIVE	To study the clinical value of the preeclampsia risk assessment system , and to explore the preventive effect of Qiju Dihuang Oral Liquid ( QDOL ) on preeclampsia patients .
METHODS	Totally 2 000 pregnant women in the gestational week 16 -20 were equally assigned to Group A and Group B by randomized sampling .
METHODS	Their preeclampsia incidence was respectively assessed by preeclampsia risk assessment system and mean arterial pressure method .
METHODS	Of them , 200 pregnant women at predicted high risk of preeclampsia were assigned to the control group and the treatment group , 100 in each group .
METHODS	All received routine treatment .
METHODS	Patients in the treatment group additionally took QDOL , 10 mL each time , twice daily ; 2 consecutive weeks per month for totally 2 weeks ; lasting for six consecutive courses or ending according to the therapeutic course .
METHODS	The incidence was observed and compared between the two groups .
RESULTS	The predicted coincidence rate of the risk assessment system was 72.3 % , higher than that of mean arterial pressure method ( 50.5 % , P < 0.05 ) .
RESULTS	The incidence rate of the treatment group was 32.0 % , lower than that of the control group ( 46.0 % , P < 0.05 ) .
CONCLUSIONS	The preeclampsia risk assessment system was more accurate .
CONCLUSIONS	QDOL could lower the incidence of preeclampsia as intervention .

###24666802
OBJECTIVE	To compare the efficacy of two modes of delivery of information for patients undergoing functional endoscopic sinus surgery : website and printed leaflet .
METHODS	A two-centre , prospective , single-blinded , randomised , controlled trial was conducted , comparing mode of information delivery .
METHODS	Adult patients were randomly allocated to receive pre-operative information regarding functional endoscopic sinus surgery , either via a website or a printed leaflet .
METHODS	Primary outcomes , measured by questionnaire , were : readability , usability and recall of complications .
RESULTS	Fifty-eight patients were recruited .
RESULTS	Fifty met the inclusion criteria , of which 40 were analysed in the study ( 20 patients per group ) , meeting the power criteria set .
RESULTS	There were 18 male and 22 female patients , ranging in age from 21 to 76 years ( mean , 47 years ) .
RESULTS	Patients found both the printed leaflet and the website readable , and were satisfied with the usability of both modes .
RESULTS	There were similar rates for recall of complications in both study arms .
CONCLUSIONS	Patient information on functional endoscopic sinus surgery can be provided either as a printed leaflet or a website , with similar rates for usability , readability and recall of complications .
CONCLUSIONS	These findings could help tailor the provision of pre-operative information for patients undergoing functional endoscopic sinus surgery , based on patient preference .

###24680105
BACKGROUND	Phenolization is often used to treat ingrown toenails .
BACKGROUND	Alcohol lavage with or without supplemental chlorhexidine may be used to remove residual phenol , which can contribute to side effects such as persistent oozing or drainage .
OBJECTIVE	We sought to compare the effectiveness in removing residual phenol of lavage with alcohol plus chlorhexidine versus alcohol alone .
METHODS	We studied 80 patients who underwent unilateral phenol matricectomy : 40 who received irrigation with alcohol alone and 40 who received irrigation with alcohol plus chlorhexidine .
METHODS	Phenol levels were measured after each of 5 rounds of 3-mL irrigations .
RESULTS	After the first irrigation , an average of 44.92 % and 38.35 % of the phenol remained in the nailfold in the alcohol and the alcohol/chlorhexidine groups , respectively ( P < .05 ) .
RESULTS	After all 5 irrigations , no difference in efficacy between the 2 solutions was found ( P > .005 ) .
CONCLUSIONS	It was not possible to calculate the quantity of phenol initially introduced into the nail bed .
CONCLUSIONS	The percentage remaining was calculated from the total amount of phenol recovered .
CONCLUSIONS	When a single irrigation step is performed after phenolization , alcohol plus chlorhexidine is more effective than alcohol alone for removing residual phenol .
CONCLUSIONS	When multiple irrigations are performed , the 2 solutions are equally effective .

###24622068
OBJECTIVE	This study aimed to investigate the clinical significance of 3-dimensional ( 3D ) reconstruction of peripancreatic vessels for patients with suspected pancreatic cancer ( PC ) .
METHODS	A total of 89 patients with PC were included ; 60 patients randomly underwent computed tomographic angiography .
METHODS	Based on the findings of 3D reconstruction of peripancreatic vessels , the appropriate method for individualized tumor resection was determined .
METHODS	These patients were compared with 29 conventionally treated patients with PC .
RESULTS	The rate of visualization was 100 % for great vessels around the pancreas .
RESULTS	The detection rates for anterior superior pancreaticoduodenal artery , posterior superior pancreaticoduodenal artery , anterior inferior pancreaticoduodenal artery , posterior inferior pancreaticoduodenal artery , dorsal pancreatic artery , superior marginal arterial branch of the pancreatic head , anterior superior pancreaticoduodenal vein , posterior superior pancreaticoduodenal vein , anterior inferior pancreaticoduodenal vein , and posterior inferior pancreaticoduodenal vein were 86.6 % , 85.0 % , 76.6 % , 71.6 % , 91.6 % , 53.3 % , 61.6 % , 55.0 % , 43.3 % , and 51.6 % , respectively .
RESULTS	Forty-three patients who had undergone 3D reconstruction underwent surgery .
RESULTS	Of the 29 conventionally treated patients , 19 underwent surgery .
RESULTS	The operative time , blood loss , length of hospital stay , and complication incidence of the 43 patients were superior to that of the 19 patients .
CONCLUSIONS	A peripancreatic vascular reconstruction can reveal the vascular anatomy , variations of peripancreatic vascular , and tumor-induced vascular changes ; the application of the simulation surgery platform could reduce surgical trauma and decrease operative time .

###25535146
OBJECTIVE	This study aims to evaluate the efficacy and safety of - lipoic acid in the treatment of aged type 2 diabetes mellitus ( T2DM ) complicated with acute cerebral infarction .
METHODS	90 patients were randomly divided into two groups , on the basis of conventional treatment .
METHODS	The experiment group was administrated with - lipoic acid , while only Vitamin C for the control group , for 3 consecutive weeks .
METHODS	Before and after the experiment , superoxide dismutase ( SOD ) , glutathione peroxidase ( GSH-Px ) and malondialdehyde ( MDA ) levels were measured and scored with the NIHSS ( National Institutes of Health Stroke Scale ) , and the changes of blood glucose , insulin function and other indicators were observed .
RESULTS	After the treatment , the plasma SOD and GSH-Px levels increased , while MDA decreased ( p < 0.05 ) , with statistical significance when compared with the control group ( p < 0.01 ) .
RESULTS	NIHSS score , blood glucose , blood lipids and HOMA-IA of the experiment group decreased significantly ( p < 0.01 ) ; and no significant adverse reactions were found in both groups .
CONCLUSIONS	- lipoic acid was safe and effective in the treatment of aged T2DM complicated with acute cerebral infarction , significantly reducing the patient 's oxidative stress , blood glucose and lipid levels and being able to improve islet function .

###25365270
OBJECTIVE	Several provincial and federal bills have recommended various forms of menu labelling that would require information beyond just calories ; however , the additional benefit of including sodium information is unknown .
OBJECTIVE	The objective of this study was to determine whether sodium information on menus helps consumers make lower-sodium choices and to understand what other factors influence the effect of menu labelling on consumers ' meal choices .
METHODS	A total of 3,080 Canadian consumers completed an online survey that included a repeated measures experiment in which consumers were asked to select what they would typically order from four mock-restaurant menus .
METHODS	Subsequently , consumers were randomly allocated to see one of three menu-labelling treatments ( calories ; calories and sodium ; or calories , sodium and serving size ) and were given the option to change their order .
RESULTS	There was a significant difference in the proportion of consumers who changed their order , varying from 17 % to 30 % , depending on the restaurant type .
RESULTS	After participants had seen menu labelling , sodium levels decreased in all treatments ( p < 0.0001 ) .
RESULTS	However , in three of the four restaurant types , consumers who saw calorie and sodium information ordered meals with significantly less sodium than consumers who saw only calorie information ( p < 0.01 ) .
RESULTS	Consumers who saw sodium labelling decreased the sodium level of their meal by an average of 171-384 mg , depending on the restaurant .
RESULTS	In the subset of consumers who saw sodium information and chose to change their order , sodium levels decreased by an average of 681-1 ,360 mg , depending on the restaurant .
RESULTS	Sex , intent to lose weight and the amount of calories ordered at baseline were the most important predictors of who used menu labelling .
RESULTS	Eighty percent of survey panelists wanted to see nutrition information when dining out .
CONCLUSIONS	Including sodium information alongside calorie information may result in a larger decrease in the amount of sodium ordered by restaurant-goers .

###24406207
BACKGROUND	A widened electrocardiographic spatial QRS-T angle has been shown to be predictive of cardiovascular disease in HIV-infected individuals .
BACKGROUND	However , determinants and risk factors of developing widened QRS-T angle over time in this population remain unknown .
RESULTS	Spatial QRS-T angle was automatically measured from standard electrocardiogram of 1444 HIV-infected individuals without baseline widened spatial QRS-T angle from the Strategies for Management of Antiretroviral Therapy [ SMART ] , a clinical trial comparing two antiretroviral treatment strategies [ Drug Conservation ( DC ) vs. Viral Suppression ( VS ) ] .
RESULTS	Conditional logistic regression analysis was used to examine the association between baseline characteristics and incident widened spatial QRS-T angle ( a new angle > 93 in males and > 74 in females ) .
RESULTS	During 2544 person-years of follow-up , 199 participants developed widened angle at a rate of 7.8 per 100 person-years .
RESULTS	In unadjusted models , female sex , black race ( vs. white ) , DC treatment strategy , current and past smokers ( vs. never ) , history of alcohol abuse , greater body mass index , history of diabetes and higher levels of hs-C-reactive protein were associated with incident widened spatial QRS-T angle .
RESULTS	When these variables were entered together in the same model with adjustment for demographics and treatment strategy , DC treatment strategy [ OR ( 95 % CI ) : 1.50 ( 1.09 , 2.07 ) ] , female gender [ 1.69 ( 1.17 , 2.45 ) ] , current and past smoking ( vs. never ) [ 2.49 ( 1.63 , 3.81 ) and 1.93 ( 1.21 , 3.09 ) , respectively ] , and diabetes [ 2.28 ( 1.33 , 3.91 ) ] predicted incident widened spatial QRS-T angle .
CONCLUSIONS	Drug conservation treatment strategy , female gender , smoking , and diabetes are independently predictive of incident widened spatial QRS-T angle in HIV-infected individuals .

###24491572
BACKGROUND	Empagliflozin is a potent , oral , selective inhibitor of sodium glucose cotransporter 2 in development for the treatment of type 2 diabetes mellitus .
OBJECTIVE	The goal of these studies was to investigate potential drug-drug interactions between empagliflozin and gemfibrozil ( an organic anion-transporting polypeptide 1B1 [ OATP1B1 ] / 1B3 and organic anion transporter 3 [ OAT3 ] inhibitor ) , rifampicin ( an OATP1B1/1B3 inhibitor ) , or probenecid ( an OAT3 and uridine diphosphate glucuronosyltransferase inhibitor ) .
METHODS	Two open-label , randomized , crossover studies were undertaken in healthy subjects .
METHODS	In the first study , 18 subjects received the following in 1 of 2 randomized treatment sequences : a single dose of empagliflozin 25 mg alone and gemfibrozil 600 mg BID for 5 days with a single dose of empagliflozin 25 mg on the third day .
METHODS	In the second study , 18 subjects received a single dose of empagliflozin 10 mg , a single dose of empagliflozin 10 mg coadministered with a single dose of rifampicin 600 mg , and probenecid 500 mg BID for 4 days with a single dose of empagliflozin 10 mg on the second day in 1 of 6 randomized treatment sequences .
RESULTS	In the gemfibrozil study , 11 subjects were male , mean age was 35.1 years and mean body mass index ( BMI ) was 23.47 kg/m ( 2 ) .
RESULTS	In the rifampicin/probenecid study , 10 subjects were male , mean age was 32.7 years and mean BMI was 23.03 kg/m ( 2 ) .
RESULTS	Exposure to empagliflozin was increased by coadministration with gemfibrozil ( AUC0 - : geometric mean ratio [ GMR ] , 158.50 % [ 90 % CI , 151.77-165 .53 ] ; Cmax : GMR , 115.00 % [ 90 % CI , 106.15-124 .59 ] ) , rifampicin ( AUC0 - : GMR , 135.20 % [ 90 % CI , 129.58-141 .06 ] ; Cmax : GMR , 175.14 % [ 90 % CI , 160.14-191 .56 ] ) , and probenecid ( AUC0 - : GMR , 153.47 % [ 90 % CI , 146.41-160 .88 ] ; Cmax : GMR , 125.60 % [ 90 % CI , 113.67-138 .78 ] ) .
RESULTS	All treatments were well tolerated .
CONCLUSIONS	Increases in empagliflozin exposure were < 2-fold , indicating that the inhibition of the OATP1B1/1B3 , OAT3 transporter , and uridine diphosphate glucuronosyltransferases did not have a clinically relevant effect on empagliflozin exposure .
CONCLUSIONS	No dose adjustments of empagliflozin were necessary when it was coadministered with gemfibrozil , rifampicin , or probenecid .
CONCLUSIONS	ClinicalTrials.gov identifiers : NCT01301742 and NCT01634100 .

###24461582
BACKGROUND	Prostaglandins that constrict and relax airways are synthesized in reactions catalyzed by either COX-1 or COX-2 .
BACKGROUND	It is not known whether selective inhibition of COX-2 makes asthmatic responses better or worse .
OBJECTIVE	To determine the effects of the selective COX-2 inhibitor , etoricoxib , on allergen-induced bronchoconstriction in asthmatic subjects .
METHODS	Sixteen subjects with mild atopic asthma underwent rising dose inhalation challenges with allergen or methacholine to determine PD20 FEV1 during a control study period or after 10 to 13 days of treatment with etoricoxib ( 90 mg once daily ) .
METHODS	The order of study periods was randomized with at least 2-week washout periods .
METHODS	Induced sputum cells and fractional exhaled nitric oxide levels were used to assess airway inflammation and blood assays for COX-1 and COX-2 activity to assess enzyme inhibition .
METHODS	Urinary excretion of lipids was used to assess prostaglandin biosynthesis .
RESULTS	Etoricoxib did not change baseline lung function , nor airway responsiveness to allergen or to methacholine .
RESULTS	Neither were the allergen-induced increase in sputum eosinophils and fractional exhaled nitric oxide levels affected by treatment .
RESULTS	The biochemical effectiveness of the treatment was established both in the blood assays and by the distinct inhibitory effect of etoricoxib on urinary excretion of tetranor-prostaglandin E2 ( P < .001 ) .
CONCLUSIONS	This first study of COX-2 inhibition in provoked asthma found no negative effects of etoricoxib on allergen-induced airflow obstruction and sputum eosinophils , basal lung function , or methacholine responsiveness .
CONCLUSIONS	The study suggests that short-term use of COX-2 inhibitors is safe in subjects with asthma .

###25661298
OBJECTIVE	Higher body mass index is linked to lower prostate specific antigen .
OBJECTIVE	This has given rise to concerns that prostate specific antigen may be less reliable for predicting prostate cancer among obese men .
OBJECTIVE	We tested the accuracy of prebiopsy prostate specific antigen for predicting prostate cancer across body mass index categories .
METHODS	We used the REDUCE study , which tested dutasteride for prostate cancer risk reduction in men with a prostate specific antigen of 2.5 to 10.0 ng/ml and a negative pre-study biopsy .
METHODS	All men were required to have a biopsy at 2 and 4 years independent of prostate specific antigen .
METHODS	We assessed the performance of prebiopsy prostate specific antigen to predict overall and high grade prostate cancer ( Gleason sum 7 or greater ) in each body mass index group using AUC .
RESULTS	Of 6,103 men who had a 2-year biopsy 1,646 ( 27 % ) were normal weight , 3,209 ( 53 % ) were overweight and 1,248 ( 20 % ) were obese .
RESULTS	Mean adjusted prostate specific antigen for normal weight , overweight and obese subjects on placebo was 7.73 , 7.17 and 6.79 ng/ml ( p-trend = 0.192 ) , and on dutasteride 3.16 , 2.93 and 2.62 ng/ml ( p = 0.008 ) .
RESULTS	AUC analysis using raw prostate specific antigen data for predicting prostate cancer ranged from 0.60 to 0.64 in the placebo arm and 0.58 to 0.66 in the dutasteride arm with no difference across body mass index categories ( p-interactions 0.212 ) .
RESULTS	Similar results were found for high grade prostate cancer with AUC ranging from 0.69 to 0.70 in the placebo arm and 0.65 to 0.75 in the dutasteride arm but no differences across body mass index categories ( p-interactions 0.157 ) .
CONCLUSIONS	Among men with a previous negative biopsy the accuracy of prebiopsy prostate specific antigen to predict overall and high grade prostate cancer was independent of body mass index .

###24579364
OBJECTIVE	To observe the clinical effect of acupoint heat-sensitive moxibustion for acut knee arthralgia and to analyze its effect on serum osteopontin ( OPN ) and matrix metalloproteinase-3 ( MMP-3 ) contents in patients with knee osteoarthritis so as to study its mechanism underlying improving arthralgia .
METHODS	One hundred and forty-four patients with acute knee knee osteoarthritis were randomly allocated to acupoint heat-sensitive moxibustion ( moxibustion ) , electroacupuncture ( EA ) and medication groups .
METHODS	Patients of the moxibustion group were treated by suspended moxibustion over bilateral Weizhong ( BL 40 ) for 40 min each point , once daily for 15 days .
METHODS	Patients of the EA group were treated by EA stimulation of Neixiyan ( EX-LE 4 ) , Dubi ( ST 35 ) , Xuehai ( SP 10 ) and Liangqiu ( ST 34 ) for 30 min , once daily for 15 days ; and those of the medication group treated by oral administration of Sanqi Tongshu capsules ( Panax Notoginseng , etc. used for promoting blood circulation and removing blood stasis ) , 3 times daily for 15 days .
METHODS	Serum OPN and MMP-3 levels were detected with ELISA .
RESULTS	Following the treatment , of the 50 , 50 and 44 cases in the moxibustion , EA and medication groups , 24 , 20 and 14 were excellent , 18 , 16 and 13 were good in therapeutic effect , 7 , 4 , and 3 were effective , and 1 , 10 , and 14 invalid , with the excellent and good rates being 84 % , 72.0 % and 61.4 % , respectively .
RESULTS	Serum OPN content of the moxibistion and EA groups , and serum MMP-3 content of the moxibustion group were reduced considerably in comparison with pre-treatment in the same one group ( P < 0.01 ) , while serum OPN level of the medication group and MMP-3 of the EA group were decreased slightly .
RESULTS	The effect of moxibustion was evidently superior to that of medication in lowering serum OPN level ( P < 0.05 ) and superior to that of both EA and medication in lowering serum MMP-3 content ( P < 0.05 ) .
CONCLUSIONS	Acupoint heat-sensitive moxibustion has a good therapeutic effect in relieving acute knee arthralgia , which may be related to its effects in decreasing serum OPN and MMP-3 levels .

###24935082
OBJECTIVE	The authors evaluated a sequential treatment strategy of fluoxetine and relapse-prevention cognitive-behavioral therapy ( CBT ) to determine effects on remission and relapse in youths with major depressive disorder .
METHODS	Youths 8-17 years of age with major depression were treated openly with fluoxetine for 6 weeks .
METHODS	Those with an adequate response ( defined as a reduction of 50 % or more on the Children 's Depression Rating Scale-Revised [ CDRS-R ] ) were randomly assigned to receive continued medication management alone or continued medication management plus CBT for an additional 6 months .
METHODS	The CBT was modified to address residual symptoms and was supplemented by well-being therapy .
METHODS	Primary outcome measures were time to remission ( with remission defined as a CDRS-R score of 28 or less ) and rate of relapse ( with relapse defined as either a CDRS-R score of 40 or more with a history of 2 weeks of symptom worsening , or clinical deterioration ) .
RESULTS	Of the 200 participants enrolled in acute-phase treatment , 144 were assigned to continuation treatment with medication management alone ( N = 69 ) or medication management plus CBT ( N = 75 ) .
RESULTS	During the 30-week continuation treatment period , time to remission did not differ significantly between treatment groups ( hazard ratio = 1.26 , 95 % CI = 0.87 , 1.82 ) .
RESULTS	However , the medication management plus CBT group had a significantly lower risk of relapse than the medication management only group ( hazard ratio = 0.31 , 95 % CI = 0.13 , 0.75 ) .
RESULTS	The estimated probability of relapse by week 30 was lower with medication management plus CBT than with medication management only ( 9 % compared with 26.5 % ) .
CONCLUSIONS	Continuation-phase relapse-prevention CBT was effective in reducing the risk of relapse but not in accelerating time to remission in children and adolescents with major depressive disorder .

###25454363
OBJECTIVE	To compare parameters after 1-piece and 3-piece intraocular lens ( IOL ) implantation .
METHODS	Moorfields West End Clinic , London , United Kingdom , and Hanusch Hospital , Vienna , Austria .
METHODS	Prospective randomized controlled trial .
METHODS	Each eye of patients having bilateral surgery for age-related cataract was randomized to have implantation of a 1-piece IOL ( Tecnis ZCB00 ) or a 3-piece IOL ( Tecnis ZA9003 ) .
METHODS	Changes in visual acuity , refraction , and anterior chamber depth ( ACD ) were evaluated during a 2-year follow-up .
METHODS	Intraocular lens tilt and decentration were evaluated using a Purkinje meter .
METHODS	Regeneratory posterior capsule opacification ( PCO ) was analyzed using retroillumination photographs in Automated Quantification of After-Cataract image-analysis software .
RESULTS	This study comprised 100 eyes of 50 patients .
RESULTS	No statistically significant differences were found in IOL tilt or decentration between groups ( P. 06 ) .
RESULTS	Minimal but statistically significant changes were observed in the vertical tilt component 12 months postoperatively in the 3-piece IOL group ( P < .01 ) .
RESULTS	The tilt and decentration components did not correlate with changes in sphere or the regeneratory PCO score ( r = 0.38 , P. 06 ) .
RESULTS	The ACD decreased significantly between 1 day and 1 month postoperatively in both groups ( P < .01 ) , with no significant changes afterward ( P. 22 ) .
RESULTS	The anterior chamber was significantly deeper in the 1-piece group at all follow-up visits ( P < .01 ) .
CONCLUSIONS	Both the 1-piece IOL and the 3-piece IOL showed excellent positional stability in the capsular bag , resulting in good clinical outcomes .
CONCLUSIONS	Regeneratory PCO levels were low and comparable between the IOLs .
BACKGROUND	No author has a financial or proprietary interest in any material or method mentioned .

###24528600
BACKGROUND	Japan is one of the most rapidly ageing societies in the world .
BACKGROUND	A number of municipalities have started services for the prevention of cognitive decline for community-dwelling elderly individuals , but the effectiveness of these services is currently insufficient .
BACKGROUND	Our study explored the efficacy of a comprehensive intervention programme consisting of physical and leisure activities to prevent cognitive decline in community-dwelling elderly subjects .
METHODS	We administered a 12-week intervention programme consisting of physical and leisure activities aimed at enhancing participants ' motivation to participate and support one another by providing a pleasant atmosphere , empathetic communication , praise , and errorless support .
METHODS	This programme for the prevention of cognitive decline was conducted as a service by the city of Maebashi .
METHODS	All participants underwent the Five-Cog test , which evaluated the cognitive domains of attention , memory , visuospatial function , language , and reasoning .
METHODS	Executive function was evaluated by the Wechsler Digit Symbol Substitution Test and Yamaguchi Kanji-Symbol Substitution Test .
METHODS	Subjective health status , level of social support , functional capacity , subjective quality of life , and depressive symptoms were assessed with a questionnaire .
METHODS	Grip strength test , timed up-and-go test , 5-m maximum walking times test , and functional reach test were performed to evaluate physical function .
METHODS	Fifty-two participants were randomly allocated to intervention ( n = 26 ) and control ( n = 26 ) groups .
METHODS	Twenty-six participants , aged between 65-87 years , received intervention once a week at a community centre .
METHODS	The programme was conducted by health-care professionals , with the help of senior citizen volunteers .
RESULTS	The intervention group ( n = 19 ) showed significant improvement on the analogy task of the Five-Cog test ( F ( 1,38 ) = 4.242 , P = 0.046 ) and improved quality of life ( F ( 1,38 ) = 4.773 , P = 0.035 ) as compared to the control group ( n = 24 ) .
CONCLUSIONS	A community-based 12-week intervention programme that aimed to enhance motivation to participate in activities resulted in improvements in some aspects of cognitive function and quality of life .
CONCLUSIONS	Senior citizens who volunteered in the present intervention enabled the smooth implementation of the programme and alleviated the burden on professional staff .

###25591391
BACKGROUND	Intermittent preventive treatment in pregnancy has not been evaluated outside of Africa .
BACKGROUND	Low birthweight ( LBW , < 2,500 g ) is common in Papua New Guinea ( PNG ) and contributing factors include malaria and reproductive tract infections .
METHODS	From November 2009 to February 2013 , we conducted a parallel group , randomised controlled trial in pregnant women ( 26 gestational weeks ) in PNG .
METHODS	Sulphadoxine-pyrimethamine ( 1,500 / 75 mg ) plus azithromycin ( 1 g twice daily for 2 days ) ( SPAZ ) monthly from second trimester ( intervention ) was compared against sulphadoxine-pyrimethamine and chloroquine ( 450 to 600 mg , daily for three days ) ( SPCQ ) given once , followed by SPCQ placebo ( control ) .
METHODS	Women were assigned to treatment ( 1:1 ) using a randomisation sequence with block sizes of 32 .
METHODS	Participants were blinded to assignments .
METHODS	The primary outcome was LBW .
METHODS	Analysis was by intention-to-treat .
RESULTS	Of 2,793 women randomised , 2,021 ( 72.4 % ) were included in the primary outcome analysis ( SPCQ : 1,008 ; SPAZ : 1,013 ) .
RESULTS	The prevalence of LBW was 15.1 % ( 305/2 ,021 ) .
RESULTS	SPAZ reduced LBW ( risk ratio [ RR ] : 0.74 , 95 % CI : 0.60-0 .91 , P = 0.005 ; absolute risk reduction ( ARR ) : 4.5 % , 95 % CI : 1.4-7 .6 ; number needed to treat : 22 ) , and preterm delivery ( 0.62 , 95 % CI : 0.43-0 .89 , P = 0.010 ) , and increased mean birthweight ( 41.9 g , 95 % CI : 0.2-83 .6 , P = 0.049 ) .
RESULTS	SPAZ reduced maternal parasitaemia ( RR : 0.57 , 95 % CI : 0.35-0 .95 , P = 0.029 ) and active placental malaria ( 0.68 , 95 % CI : 0.47-0 .98 , P = 0.037 ) , and reduced carriage of gonorrhoea ( 0.66 , 95 % CI : 0.44-0 .99 , P = 0.041 ) at second visit .
RESULTS	There were no treatment-related serious adverse events ( SAEs ) , and the number of SAEs ( intervention 13.1 % [ 181/1 ,378 ] , control 12.7 % [ 174/1 ,374 ] , P = 0.712 ) and AEs ( intervention 10.5 % [ 144/1 ,378 ] , control 10.8 % [ 149/1 ,374 ] , P = 0.737 ) was similar .
RESULTS	A major limitation of the study was the high loss to follow-up for birthweight .
CONCLUSIONS	SPAZ was efficacious and safe in reducing LBW , possibly acting through multiple mechanisms including the effect on malaria and on sexually transmitted infections .
CONCLUSIONS	The efficacy of SPAZ in the presence of resistant parasites and the contribution of AZ to bacterial antibiotic resistance require further study .
CONCLUSIONS	The ability of SPAZ to improve pregnancy outcomes warrants further evaluation .
BACKGROUND	ClinicalTrials.gov NCT01136850 ( 06 April 2010 ) .

###25280414
OBJECTIVE	Dietary strategies in heart failure ( HF ) are focused on sodium and fluid restriction to minimize the risk for acute volume overload episodes .
OBJECTIVE	However , the importance of dietary factors beyond sodium intake in the prognosis of the disease is uncertain .
OBJECTIVE	The purpose of this study was to evaluate the association of macro - and micronutrients intake on 1-y mortality in patients with HF .
METHODS	A secondary analysis of 203 patients with chronic HF enrolled in a randomized trial of sodium reduction was completed .
METHODS	Patients with a complete 3-d food record at baseline were included in this analysis ( N = 118 ) ; both control and intervention arms were combined .
METHODS	Three-d mean dietary intake was estimated .
METHODS	Cox multivariable regression analysis was used to evaluate the association between dietary factors and 1-y mortality .
RESULTS	Among the 118 included patients , 54 % were men , median ( 25th-75th percentiles ) age 66 y ( 52-75 y ) , median ejection fraction 45 % ( 30 % -60 % ) , and ischemic etiology present in 49 % of patients .
RESULTS	The association with 1-y mortality was significant for both polyunsaturated fatty acids ( PUFA ; adjusted hazard ratio [ HR ] , 0.67 ; 95 % confidence interval [ CI ] .
RESULTS	0.51-0 .86 for intake as percentage of daily energy ) and saturated fatty acids ( SFA ; adjusted HR , 1.15 ; 95 % CI , 1.03-1 .30 for intake as percentage of daily energy ) .
RESULTS	Median of intake as percentage of daily energy was 5.3 % for PUFAs and 8.2 % for SFAs .
CONCLUSIONS	Intake of PUFAs and SFAs was independently associated with 1-y all-cause mortality in patients with chronic HF .
CONCLUSIONS	Limiting dietary SFA and increasing PUFA intake may be advisable in this population .

###25105547
OBJECTIVE	The aim of this study was to evaluate the effectiveness of a supervised exercise program ( SEP ) plus at home nonsupervised exercise therapy ( non-SET ) on functional status , quality of life ( QoL ) and hemodynamic response in post-lower-limb bypass surgery patients .
RESULTS	One hundred and seventeen patients were randomized to an intervention ( n = 57 ) or a control group ( n = 60 ) .
RESULTS	A new individual SEP was designed for patients with peripheral arterial disease ( PAD ) and applied to the studied subjects of the intervention group who also continued non-SET at home , whereas those assigned to the control group received just usual SEP according to a common cardiovascular program .
RESULTS	The participants of the study were assessed by a 6-min walking test ( 6 MWT ) , an ankle-brachial index ( ABI ) , and the Medical Outcomes Study Short Form-36 ( SF-36 ) of QoL at baseline , at 1 and 6 months after surgery .
RESULTS	A significant improvement was observed in the walked distance in the intervention group after 6 months compared with the control group ( p < 0.001 ) .
RESULTS	The intervention group had significantly higher QoL score in the physical and mental component of SF-36 ( p < 0.05 ) .
CONCLUSIONS	A 6-month application of the new SEP and non-SET at home has yielded significantly better results in walking distance and QoL in the intervention group than in the controls .

###25306139
BACKGROUND	Vaccination as a control method against the cattle tick , Rhipicephalus ( Boophilus ) microplus has been practiced since the introduction of two products in the mid-1990s .
BACKGROUND	There is a need for a vaccine that could provide effective control of R. microplus in a more consistent fashion than existing products .
BACKGROUND	During our transcriptome studies of R. microplus , several gene coding regions were discovered to encode proteins with significant amino acid similarity to aquaporins .
METHODS	A cDNA encoding an aquaporin from the cattle tick , Rhipicephalus microplus , was isolated from transcriptomic studies conducted on gut tissues dissected from fully engorged adult female R. microplus .
RESULTS	Bioinformatic analysis indicates this aquaporin , designated RmAQP1 , shows greatest amino acid similarity to the human aquaporin 7 family .
RESULTS	Members of this family of water-conducting channels can also facilitate the transport of glycerol in addition to water .
RESULTS	The efficacy of this aquaporin as an antigen against the cattle tick was explored in cattle vaccine trials conducted in Brazil .
RESULTS	A cDNA encoding a significant portion of RmAQP1 was expressed as a recombinant protein in Pichia pastoris , purified under native conditions using a polyhistidine C-terminus tag and nickel affinity chromatography , emulsified with Montanide adjuvant , and cattle vaccinated intramuscularly .
RESULTS	The recombinant protein provided 75 % and 68 % efficacy in two cattle pen trials conducted in Campo Grande , Brazil on groups of 6 one year old Holstein calves .
CONCLUSIONS	The effectiveness of this vaccine in reducing the numbers of adult female ticks shows this aquaporin antigen holds promise as an active ingredient in cattle vaccines targeted against infestations of R. microplus .

###25065693
OBJECTIVE	Previous investigations suggested that cherry blossoms could provide valuable bioactive materials .
OBJECTIVE	However , few observations regarding the anti-inflammatory effect of cherry blossoms were reported .
OBJECTIVE	This study was to explore the anti-inflammatory effect of cherry blossom extract ( CBE ) , which was used as a soothing ingredient in skincare product .
METHODS	In vitro study , the anti-inflammatory effect of CBE on the nitric oxide ( NO ) inhibition assay in lipopolysaccharide ( LPS ) - treated RAW 264.7 cells was investigated .
METHODS	In vivo study , 40 volunteers were included in a randomized , single-blinded , placebo-controlled trial .
METHODS	24-hour-occlusive test chambers were applied on the flexor side of the forearm with 3 % sodium lauryl sulphate ( SLS ) .
METHODS	Subsequently , the test areas were treated on 9 subsequent days with a cream containing 3 % CBE or a placebo .
METHODS	Evaluation included a visual score and determination of erythema value ( E value ) .
RESULTS	In vitro study , 2 % CBE reduced NO production by 31.83 % compared to the placebo .
RESULTS	In the SLS irritant patch test , the visual score and erythema value of CBE were lower than that of the placebo on D5 and D9 .
CONCLUSIONS	Cherry blossom extract shows good anti-inflammatory effect in vitro and in vivo and represents a promising functional ingredient in soothing skincare product by reducing skin inflammation .

###24366395
BACKGROUND	Recent and national data on adherence to heart failure drugs are limited , particularly among the disabled and some small minority groups , such as Native Americans and Hispanics .
OBJECTIVE	We compare medication adherence among Medicare patients with heart failure , by disability status , race/ethnicity , and income .
METHODS	Observational study .
METHODS	US Medicare Parts A , B , and D data , 5 % random sample , 2007-2009 .
METHODS	149,893 elderly Medicare beneficiaries and 21,204 disabled non-elderly beneficiaries .
METHODS	We examined 5 % of Medicare fee-for-service beneficiaries with heart failure in 2007-2009 .
METHODS	The main outcome was 1-year adherence to one of three therapeutic classes : - blockers , diuretics , and angiotensin-converting enzyme inhibitors ( ACEIs ) / angiotensin II receptor blockers ( ARBs ) .
METHODS	Adherence was defined as having prescriptions in possession for 75 % of days .
RESULTS	Among aged beneficiaries , 1-year adherences to at least one heart failure drug were 63 % , 57 % , 53 % , 50 % , and 52 % for Whites , Asians , Hispanics , Native Americans and Blacks , respectively ; among the disabled , 1-year adherence was worse for each group : 57 % , 53 % , 48 % , 44 % and 43 % respectively .
RESULTS	The racial/ethnic difference persisted after adjustment for age , gender , income , drug coverage , location and health status .
RESULTS	Patterns of adherence were similar among beneficiaries on all three therapeutic classes .
RESULTS	Among beneficiaries with close-to-full drug coverage , minorities were still less likely to adhere relative to Whites , OR = 0.61 ( 95 % CI 0.58-0 .64 ) for Hispanics , OR = 0.59 ( 95 % CI 0.57-0 .62 ) for Blacks and OR = 0.57 ( 95 % CI 0.47-0 .68 ) for Native Americans .
CONCLUSIONS	After the implementation of Medicare Part D , adherence to heart failure drugs remains problematic , especially among disabled and minority beneficiaries , including Native Americans , Blacks , and Hispanics .
CONCLUSIONS	Even among those with close-to-full drug coverage , racial differences remain , suggesting that policies simply relying on cost reduction can not eliminate racial differences .

###26227099
OBJECTIVE	Corifollitropin alfa ( Elonva ) is the first hybrid follicle-stimulating hormone molecule with demonstrated sustained follicle-stimulating activity after a single subcutaneous injection .
OBJECTIVE	This trial evaluated if corifollitropin alfa is associated with QT/QTc prolongation and / or proarrhythmic potential as compared to placebo in healthy post-menopausal women .
METHODS	Participants were healthy , postmenopausal women .
METHODS	Study treatments were corifollitropin alfa 150 g , corifollitropin alfa 240 g , and moxifloxacin 400 mg with placebo .
METHODS	This randomized , double blind , double-dummy , 4-period crossover trial compared single doses of corifollitropin alfa 150 g ( therapeutic dose ) , corifollitropin alfa 240 g ( supratherapeutic dose ) , and moxifloxacin 400 mg ( positive control ) with placebo .
METHODS	Corifollitropin alfa was administered on day 1 and moxifloxacin on day 2 .
RESULTS	The largest time-matched mean QTcF difference versus placebo for the therapeutic dose of corifollitropin alfa was 1.4 ms ( upper limit of 1-sided 95 % confidence interval ( UL 95 % CI ) = 3.4 ms ) , and for the supratherapeutic dose was 1.2 ms ( UL 95 % CI = 3.6 ms ) .
CONCLUSIONS	For both the therapeutic and the supratherapeutic dose of corifollitropin alfa and at all time points , the UL 95 % CI for the time matched QTcF differences compared with placebo was below 10 ms , the threshold of relevance defined by the ICH E14 guideline .
CONCLUSIONS	Single therapeutic and supratherapeutic doses of corifollitropin alfa are not associated with clinically relevant QT/QTc-interval prolongation in healthy post-menopausal women .

###25467927
BACKGROUND	No reference second-line treatment of small-cell lung cancer is available .
BACKGROUND	The aim of the present phase II randomized trial ( Groupe Franais de Pneumo-Cancrologie 0501 ) was to compare , in patients with progressive small-cell lung cancer after first-line platinum-based chemotherapy , oral multidrug chemotherapy ( lomustine , cyclophosphamide , etoposide ) and intravenous therapy with cyclophosphamide , doxorubicin , and vincristine ( CAV ) in terms of efficacy and tolerance .
BACKGROUND	The primary endpoint was overall survival .
BACKGROUND	The secondary endpoints were progression-free survival , response rate , and tolerance .
METHODS	The study randomized 131 patients ( 76.7 % male ; median age , 61 8.1 years , 85.5 % with a performance status of 0-1 ) , 65 to oral therapy and 66 to the CAV arm .
METHODS	No statistically significant differences were found in the baseline patient characteristics .
RESULTS	The OS and PFS was 6.1 and 3 months for the oral arm and 5.8 and 3.1 months for the CAV arm , respectively .
RESULTS	The control disease rate was 61.6 % and 45.5 % in oral and CAV arms , respectively .
RESULTS	No unexpected adverse events occurred , and no statistically significant difference was found between the 2 arms in terms of toxicity ( grade 4 hematologic adverse events in 32.3 % and 31.8 % of patients in the oral and CAV arms , respectively ) .
CONCLUSIONS	Compared with CAV , oral therapy in this setting appears as feasible as , but not superior to , the efficacy in the CAV arm .

###24257725
BACKGROUND	The regional Mediterranean Diet has been associated with lower risk of disease .
OBJECTIVE	We tested the health effects of the New Nordic Diet ( NND ) , which is a gastronomically driven regional , organic , and environmentally friendly diet , in a carefully controlled but free-living setting .
METHODS	A total of 181 centrally obese men and women , with a mean ( range ) age of 42 y ( 20-66 y ) , body mass index ( in kg/m ( 2 ) ) of 30.2 ( 22.6-47 .3 ) , and waist circumference of 100 cm ( 80-138 cm ) were randomly assigned to receive either the NND ( high in fruit , vegetables , whole grains , and fish ) or an average Danish diet ( ADD ) for 26 wk .
METHODS	Participants received cookbooks and all foods ad libitum and free of charge by using a shop model .
METHODS	The primary endpoint was the weight change analyzed by both completer and intention-to-treat analyses .
RESULTS	A total of 147 subjects [ 81 % ( NND 81 % ; ADD 82 % ) ] completed the intervention .
RESULTS	A high dietary compliance was achieved , with significant differences in dietary intakes between groups .
RESULTS	The mean ( SEM ) weight change was -4.7 0.5 kg for the NND compared with -1.5 0.5 kg for the ADD ( adjusted difference : -3.2 kg ; 95 % CI : -4.6 , -1.8 kg ; P < 0.001 ) for the completer analysis , and the difference was -3.0 kg ( 95 % CI : -4.0 , -2.1 kg ) for the intention-to-treat analysis .
RESULTS	The NND produced greater reductions in systolic blood pressure ( adjusted difference : -5.1 mm Hg ; 95 % CI : -8.2 , -2.1 mm Hg ) and diastolic blood pressure ( adjusted difference : -3.2 mm Hg ; 95 % CI : -5.7 , -0.8 mm Hg ) than did the ADD .
CONCLUSIONS	An ad libitum NND produces weight loss and blood pressure reduction in centrally obese individuals .
CONCLUSIONS	This trial was registered at www.clinicaltrials.gov as NCT01195610 .

###25127011
BACKGROUND	Women stopping alendronate are commonly monitored with serial bone mineral density ( BMD ) measurements , yet no information exists on how frequently or for whom these measurements should be performed .
OBJECTIVE	The objective of the study was to develop a tool to guide post-alendronate BMD monitoring .
METHODS	A predictive model was constructed to estimate the time until a given percentage of women 's BMD T-scores drop below a given threshold that indicates a management change ( such as retreatment ) would be considered .
METHODS	This model was then used to estimate the time it would take for groups of women defined by their baseline BMDs to drop below the given threshold .
METHODS	Data were derived from the Fracture Intervention Trial Long Term Extension ( FLEX ) , the largest multicenter clinical trial of its type to date .
METHODS	Four hundred four women who had received an average of 5.1 years of alendronate during the Fracture Intervention Trial and were subsequently observed for 5 treatment-free years ( on placebo ) during the FLEX trial were used to estimate the change in BMD over time .
RESULTS	If a management change such as alendronate reinitiation would be considered when BMD T-score drops below -2.5 , the model shows that women with total hip BMD greater than -1.9 T-scores at the time of alendronate discontinuation have less than a 20 % probability that at follow-up , monitoring BMD will be below the threshold within 5 years .
RESULTS	The model performed similarly , and results are provided over a range of management change thresholds from -1.75 to -3 T-scores .
CONCLUSIONS	Using the tool developed in this analysis , it is possible to estimate when BMD repeat measurement after alendronate discontinuation could potentially be useful .
CONCLUSIONS	Measuring BMD within 5 years after alendronate discontinuation is unlikely to change management for women with total hip BMD 0.6 T-scores above a prespecified retreatment threshold within the range of -1.75 to -3 T-scores .

###24296325
BACKGROUND	Home-based management of malaria ( HMM ) may improve access to diagnostic testing and treatment with artemisinin combination therapy ( ACT ) .
BACKGROUND	In the Sahel region , seasonal malaria chemoprevention ( SMC ) is now recommended for the prevention of malaria in children .
BACKGROUND	It is likely that combinations of antimalarial interventions can reduce the malaria burden .
BACKGROUND	This study assessed the feasibility , effectiveness and safety of combining SMC and HMM delivered by community health workers ( CHWs ) .
METHODS	A cluster-randomised trial was carried out during two transmission seasons in eight villages located in the south-eastern part of Senegal .
METHODS	Intervention communities received HMM+SMC while control communities received HMM .
METHODS	Primary end point was the incidence of malaria attacks during the follow up period .
METHODS	Secondary end points included : malaria diagnostic accuracy ; access to ACT treatment ; SMC coverage ; safety and drug tolerability .
RESULTS	The adjusted rate ratio for incidence of malaria attacks in intervention and control communities was 0.15 , indicating a protective effect of HMM+SMC of 85 % ( 95 % CI : 39.9-96 .3 % , p = 0.01 ) .
RESULTS	Access to ACT treatment was 96.4 % while SMC coverage represented 97.3 % ( 95 % CI : 91.3-100 % ) in 2010 , and 88.8 % ( 95 % CI : 84.2-93 .6 % ) in 2011 .
RESULTS	No serious adverse events were recorded .
CONCLUSIONS	It seems feasible and safe to combine SMC with HMM intervention , while achieving high coverage and effectiveness of both SMC and HMM .
BACKGROUND	( www.pactr.org ) PACTR201305000551876 .

###25422168
OBJECTIVE	To evaluate the usability of the educational needs assessment tool in clinical practice , from a practitioner and patient perspective and to establish whether patients perceive that they are getting an equally good or equally inadequate education service for their needs .
BACKGROUND	The educational needs assessment tool was developed to enable patients with Rheumatoid Arthritis to assess their education needs prior to a consultation with a health professional .
BACKGROUND	The educational needs assessment tool has been translated into nine languages and measurement properties have been established , however , its usability in clinical practice has not been studied .
METHODS	A qualitative study embedded into a multicentre RCT in which patients had been randomised into either educational needs assessment tool-focused education ( Experimental Group ) or usual care ( control group ) .
METHODS	Both groups were seen by a clinical nurse specialist .
METHODS	Sixteen patients and four clinical nurse specialists were recruited from the Rheumatology Outpatient Departments of three Acute Hospitals within the U K. Data were collected by interviews with patients and clinical nurse specialist .
METHODS	Analysis followed the Framework approach .
RESULTS	Patients and clinical nurse specialist found completion of the educational needs assessment tool straightforward , comprehensive and easy to use .
RESULTS	Completing the educational needs assessment tool helped patients to focus on what they needed to know from the clinical nurse specialist .
RESULTS	Patients in both the control group and the experimental group felt supported and reassured by their clinical nurse specialist and perceived that they received a good and adequate education provision .
CONCLUSIONS	This study provides useful insights into the ability of the educational needs assessment tool to assess the educational needs of patients with rheumatoid arthritis in routine clinical practice .
CONCLUSIONS	The educational needs assessment tool would be useful as a structured guide for nurses when assessing and meeting individual patient educational needs .
CONCLUSIONS	This has the potential to improve patient-centred care , involve patients more actively in their care and enhance the long-term effects of patient education provision .

###25092377
BACKGROUND	The course of posttraumatic stress disorder ( PTSD ) is frequently and severely complicated by co-occurring alcohol use disorder ( AUD ) , yet there are few reports of pharmacologic treatments for these comorbid conditions .
BACKGROUND	The objective of this pilot study was to obtain a preliminary assessment of the efficacy and safety of topiramate in reducing alcohol use and PTSD symptoms in veterans with both disorders .
METHODS	This was a prospective 12-week , randomized , double-blind , placebo-controlled pilot trial of flexible-dose topiramate up to 300mg/d in 30 veterans with PTSD and AUD .
METHODS	The primary outcome measure was frequency of drinking .
METHODS	Secondary outcomes consisted of other measures of alcohol use and PTSD symptom severity .
RESULTS	Within-group analyses showed that topiramate treatment was associated with significant reductions in frequency and amount of alcohol use and alcohol craving from baseline through week 12 .
RESULTS	Between-group analyses showed that topiramate reduced frequency of alcohol use and alcohol craving significantly more than placebo and tended to reduce drinking amount .
RESULTS	Topiramate treatment was also associated with decreased PTSD symptom severity and tended to reduce hyperarousal symptoms compared with placebo .
RESULTS	Topiramate transiently impaired learning and memory , with significant recovery by the end of treatment .
CONCLUSIONS	These preliminary results indicate that in veterans with co-occurring PTSD and AUD , topiramate may be effective in reducing alcohol consumption , alcohol craving , and PTSD symptom severity-particularly hyperarousal symptoms .
CONCLUSIONS	Topiramate was associated with transient cognitive impairment but was otherwise well tolerated .

###24705418
BACKGROUND	Urinary tract infections ( UTIs ) are common and result in an enormous economic burden .
BACKGROUND	The increasing prevalence of antibiotic-resistant microorganisms has stimulated interest in non-antibiotic agents to prevent UTIs .
OBJECTIVE	To evaluate the cost-effectiveness of cranberry prophylaxis compared to antibiotic prophylaxis with trimethoprim-sulfamethoxazole ( TMP-SMX ) over a 12 month period in premenopausal women with recurrent UTIs .
METHODS	An economic evaluation was performed alongside a randomized trial .
METHODS	Primary outcome was the number of UTIs during 12 months .
METHODS	Secondary outcomes included satisfaction and quality of life .
METHODS	Healthcare utilization was measured using questionnaires .
METHODS	Missing data were imputed using multiple imputation .
METHODS	Bootstrapping was used to evaluate the cost-effectiveness of the treatments .
RESULTS	Cranberry prophylaxis was less effective than TMP-SMX prophylaxis , but the differences in clinical outcomes were not statistically significant .
RESULTS	Costs after 12 months in the cranberry group were statistically significantly higher than in the TMP-SMX group ( mean difference 249 , 95 % confidence interval 70 to 516 ) .
RESULTS	Cost-effectiveness planes and cost-effectiveness acceptability curves showed that cranberry prophylaxis to prevent UTIs is less effective and more expensive than ( dominated by ) TMP-SMX prophylaxis .
CONCLUSIONS	In premenopausal women with recurrent UTIs , cranberry prophylaxis is not cost-effective compared to TMP-SMX prophylaxis .
CONCLUSIONS	However , it was not possible to take into account costs attributed to increased antibiotic resistance within the framework of this randomized trial ; modeling studies are recommended to investigate these costs .
CONCLUSIONS	Moreover , although we based the dosage of cranberry extract on available evidence , this may not be the optimal dosage .
CONCLUSIONS	Results may change when this optimal dosage is identified .
BACKGROUND	ISRCTN.org ISRCTN50717094 .

###24476536
BACKGROUND	The implantation process after embryo transfer depends on the embryo quality and endometrial receptivity .
BACKGROUND	It is estimated that fifty to seventy-five per cent of pregnancies are lost due to a failure of implantation .
BACKGROUND	There is evidence that there is an early secretion of human chorionic gonadotrophin before embryo implantation , and this secretion has been linked to an important function in angiogenesis and the inflammatory response that promotes the implantation process .
BACKGROUND	Our objective was to determine the effects of intrauterine injection of human chorionic gonadotropin ( hCG ) before the embryo transfer in an in vitro fertilisation cycle .
METHODS	A prospective randomised study was conducted in Reproductive Medicine Centre PROCREA in Mexico City .
METHODS	Infertile patients who had a medical indication for in vitro fertilisation were studied .
METHODS	Two groups were included ( n 210 ) ; the intervention group received an intrauterine injection of 500IU of hCG before the embryo transfer ( n 101 ) .
METHODS	The control group ( n 109 ) did not receive hCG .
METHODS	Comparisons were performed using a chi-square test .
RESULTS	The clinical pregnancy rate ( CPR ) was our principal outcome .
RESULTS	The implantation rate was a secondary outcome .
RESULTS	The implantation rate was significantly higher in the hCG group compared to the control group ( 52.4 % vs 35.7 % , p 0.014 ) .
RESULTS	The clinical pregnancy rate was also significantly higher ( 50.4 vs 33.0 % , p 0.010 ) .
RESULTS	No adverse effects were observed .
CONCLUSIONS	The intrauterine injection of hCG before embryo transfer showed a significant increase in the clinical pregnancy rate .
CONCLUSIONS	More clinical trials are needed to reproduce these results on this promising intervention .
CONCLUSIONS	The live birth rate must be included in subsequent studies .

###24741684
BACKGROUND	Concentric ( CON ) and eccentric ( ECC ) contractions may involve different mechanisms related to changes in sarcolemma status and the consequent alteration of action potential transmission along muscle fibers .
METHODS	Muscle conduction velocity ( CV ) , surface electromyography signal ( sEMG ) , muscle quality , and blood lactate concentrations were analyzed during CON and ECC actions .
RESULTS	Compared with ECC , the CON protocol resulted in greater muscle force losses , blood lactate concentrations , and changes in sEMG parameters .
RESULTS	Similar reductions in CV were detected in both protocols .
RESULTS	Higher echo intensity values were observed 2 days after ECC due to greater muscle damage .
CONCLUSIONS	The effects of the muscle damage produced by ECC exercise on the transmission of action potentials along muscle fibers ( measured as the CV ) may be comparable with the effects of hydrogen accumulation produced by CON exercise ( related to greater lactate concentrations ) , which causes greater force loss and change in other sEMG variables during CON than during ECC actions .

###24422887
OBJECTIVE	To investigate the role of genetic polymorphisms in candidate genes associated with the HPA axis and their interactions with environmental stressors in antidepressant response .
METHODS	The remission of depressive symptoms after 8 weeks of antidepressant treatment was tested against 21 single nucleotide polymorphisms ( SNPs ) in five candidate genes associated with the HPA axis in a Chinese Han sample suffering from unipolar depression ( n = 273 ) .
METHODS	Any history of childhood trauma and recent negative life events were measured using the Childhood Trauma Questionnaire-Short Form ( CTQ-SF ) ( n = 206 ) and the Life Event Scale ( 48 item , LES ) ( n = 207 ) , respectively .
METHODS	Reporter gene assays were used to evaluate the possible effects of the most significant SNP on gene expression .
RESULTS	A functional polymorphism at 3 ` UTR of the corticotropin-releasing hormone receptor 1 ( CRHR1 ) gene ( rs28364032 ) and three haplotypes containing it showed significant relationships with antidepressant remission .
RESULTS	Further laboratory-based genomic studies showed that the G-to-A change of rs28364032 resulted in a 10-12 % decrease in the intensity of luciferase activity .
RESULTS	However , we failed to find association of environments and their interaction with HPA system-related genes with antidepressant remission .
CONCLUSIONS	Our results support a definite role for CRHR1 in the pharmacogenetics of antidepressant drugs .
CONCLUSIONS	This may contribute to interpatient differences in their responses to antidepressant drugs .

###24377455
OBJECTIVE	Oxidative stress and inflammation are involved in the pathogenesis of non-alcoholic fatty liver disease ( NAFLD ) .
OBJECTIVE	Bayberries contain high levels of polyphenols that possess antioxidative and anti-inflammatory properties invitro .
OBJECTIVE	The purpose of this study was to investigate whether the consumption of bayberry juice beneficially alters the levels of oxidative , inflammatory , and apoptotic biomarkers in young individuals with features of NAFLD .
METHODS	In this randomized , placebo-controlled , double-blind , crossover study , 44 participants ( ages 18-25 y ) were given 250 mL of either bayberry juice or placebo twice daily for 4 wk .
METHODS	Several anthropometric characteristics were measured , and fasting blood samples were drawn before and after each intervention period .
METHODS	The levels of plasma glucose , insulin , lipids , and some NAFLD-related biomarkers were determined .
RESULTS	No significant effects on the anthropometric parameters and the homeostasis model assessment for insulin resistance were observed .
RESULTS	Compared with placebo , the consumption of bayberry juice significantly decreased the plasma levels of protein carbonyl groups ( P = 0.038 ) , tumor necrosis factor - ( P < 0.001 ) , and interleukin-8 ( P = 0.022 ) .
RESULTS	The apoptosis markers analysis revealed significant differences between the treatment and the placebo in the levels of tissue polypeptide-specific antigen ( P < 0.001 ) and cytokeratin-18 fragment M30 ( P < 0.001 ) .
CONCLUSIONS	The consumption of bayberry juice for a period of 4 wk can protect against NAFLD in young adults by improving the plasma antioxidant status and inhibiting the inflammatory and apoptotic responses that are involved in this disease .

###24304033
OBJECTIVE	This study examined women 's perceptions of early infant feeding experiences and identified early postpartum barriers to successful breastfeeding .
METHODS	We conducted semistructured exit interviews at 6 months postpartum with a subsample of participants ( n = 67 ) enrolled in two randomized controlled trials of breastfeeding promotion .
METHODS	Study arms included ( 1 ) routine pre - and postnatal visits with an International Board Certified Lactation Consultant ( IBCLC ) ( LC group ) , ( 2 ) electronically prompted guidance from prenatal care providers ( EP group ) , ( 3 ) EP+LC combined , and ( 4 ) standard of care ( control group ) .
METHODS	Interview transcripts were coded using grounded theory and analyzed in MAXqda .
METHODS	Code matrices were used to identify early postpartum breastfeeding barriers and were further examined in relation to treatment group using a mixed methods analysis .
RESULTS	The majority of the participants reported experiencing at least one barrier to breastfeeding .
RESULTS	Barriers to breastfeeding were more commonly reported in the early postpartum than late postpartum period .
RESULTS	The most common barrier during the early postpartum period was the perception of inadequate milk supply ( `` lactational '' ) ( n = 18 ) , followed by problems with latch , medical problems that were perceived as precluding breastfeeding , and medical staff and hospital practices .
RESULTS	Participants frequently reported that the IBCLCs assisted them in anticipating , managing , and overcoming these barriers .
CONCLUSIONS	Our findings underscore the importance of integrating IBCLCs into routine pre - and postpartum care because they provide critical support that effectively addresses early postpartum barriers to breastfeeding .

###25033717
OBJECTIVE	This study aimed at evaluating the effect of vaginal intercourse on spontaneous labor onset at term .
METHODS	In a randomized controlled trial , patients with singleton , cephalic , term , and low-risk pregnancy were assigned to either vaginal intercourse at least twice a week or abstinence .
METHODS	The following data were assessed : demographics , parity , vaginal coitus frequency before and during pregnancy , Bishop score at 38th weeks , gestational age at delivery , mode of delivery , and days between recruitment and delivery .
METHODS	The primary outcome was spontaneous labor onset .
RESULTS	Of the 123 patient analyzed , 63 were assigned to study group and 60 to control group .
RESULTS	Mean interval between study recruitment and delivery was higher in sexually active women ( 15.05 days 0.8 compared with 14.17 days 0.8 , p = 0.45 ) as well as the rate of cesarean delivery ( 14.3 % compared with 10 % , p = 0.58 ) , but the differences were not statistically significant .
RESULTS	The rate of spontaneous labor was similar in both groups ( 84.1 % in vaginal coitus group ; 75 % in control group , p = 0.26 ) .
CONCLUSIONS	Our results showed that vaginal intercourse does not hasten spontaneous labor onset at term .

###24465570
BACKGROUND	The impact on carriage and optimal schedule for primary vaccination of older children with 10-valent pneumococcal non-typeable Haemophilus influenzae protein-D conjugate vaccine ( PHiD-CV ) are unknown .
METHODS	600 Kenyan children aged 12-59 months were vaccinated at days 0 , 60 and 180 in a double-blind randomized controlled trial according to the following vaccine sequence : Group A : PHiD-CV , PHiD-CV , diphtheria/tetanus/acellular pertussis vaccine ( DTaP ) ; Group B : PHiD-CV , DTaP , PHiD-CV ; Group C : hepatitis A vaccine ( HAV ) , DTaP , HAV .
METHODS	Nasopharyngeal carriage of Streptococcus pneumoniae was measured at five timepoints .
METHODS	In 375 subjects , serotype-specific responses were measured by 22F-inhibition ELISA and opsonophagocytic killing assays ( OPA ) one month after vaccination .
RESULTS	Following one dose of PHiD-CV , > 90 % of recipients developed IgG0 .35 g/mL to serotypes 1 , 4 , 5 , 7F , 9V and 18C and OPA8 to serotypes 4 , 7F , 9V , 18C , 23F .
RESULTS	After a second dose > 90 % of recipients had IgG0 .35 g/mL to all vaccine serotypes and OPA8 to all vaccine serotypes except 1 and 6B .
RESULTS	At day 180 , carriage of vaccine-type pneumococci was 21 % in recipients of two doses of PHiD-CV ( Group A ) compared to 31 % in controls ( p = 0.04 ) .
RESULTS	Fever after dose 1 was reported by 41 % of PHiD-CV recipients compared to 26 % of HAV recipients ( p < 0.001 ) .
RESULTS	Other local and systemic adverse experiences were similar between groups .
CONCLUSIONS	Vaccination of children aged 12-59 months with two doses of PHiD-CV two to six months apart was immunogenic , reduced vaccine-type pneumococcal carriage and was well-tolerated .
CONCLUSIONS	Administration of PHiD-CV would be expected to provide effective protection against vaccine-type disease .
BACKGROUND	ClinicalTrials.gov NCT01028326 .

###25086646
BACKGROUND	Understanding exercise participation for overweight and obese adults is critical for preventing comorbid conditions .
BACKGROUND	Group-based high-intensity functional training ( HIFT ) provides time-efficient aerobic and resistance exercise at self-selected intensity levels which can increase adherence ; behavioral responses to HIFT are unknown .
BACKGROUND	This study examined effects of HIFT as compared to moderate-intensity aerobic and resistance training ( ART ) on exercise initiation , enjoyment , adherence , and intentions .
METHODS	A stratified , randomized two-group pre-test posttest intervention was conducted for eight weeks in 2012 with analysis in 2013 .
METHODS	Participants ( n = 23 ) were stratified by median age ( < or 28 ) and body mass index ( BMI ; < or 30.5 ) .
METHODS	Participants were physically inactive with an average BMI of 31.1 3.5 kg/m2 , body fat percentage of 42.0 7.4 % , weight of 89.5 14.2 kg , and ages 26.8 5.9 years .
METHODS	Most participants were white , college educated , female , and married/engaged .
METHODS	Both groups completed 3 training sessions per week .
METHODS	The ART group completed 50 minutes of moderate aerobic exercise each session and full-body resistance training on two sessions per week .
METHODS	The HIFT group completed 60-minute sessions of CrossFit with actual workouts ranging from 5-30 minutes .
METHODS	Participants completed baseline and posttest questionnaires indicating reasons for exercise initiation ( baseline ) , exercise enjoyment , and exercise intentions ( posttest ) .
METHODS	Adherence was defined as completing 90 % of exercise sessions .
METHODS	Daily workout times were recorded .
RESULTS	Participants provided mostly intrinsic reasons for exercise initiation .
RESULTS	Eighteen participants adhered ( ART = 9 , 81.8 % ; HIFT = 9 , 75 % ) .
RESULTS	HIFT dropouts ( p = .012 ) and ART participants ( p = .009 ) reported lower baseline exercise enjoyment than HIFT participants , although ART participants improved enjoyment at posttest ( p = .005 ) .
RESULTS	More HIFT participants planned to continue the same exercise than ART participants ( p = .002 ) .
RESULTS	No significant changes in BMI or body composition were found .
RESULTS	Workouts were shorter for HIFT than ART ( p < .001 ) .
CONCLUSIONS	HIFT participants spent significantly less time exercising per week , yet were able to maintain exercise enjoyment and were more likely to intend to continue .
CONCLUSIONS	High-intensity exercise options should be included in public health interventions .
BACKGROUND	ClinicalTrials.gov Identifier : http://NCT02185872 .
BACKGROUND	Registered 9 July 2014 .

###25909422
BACKGROUND	Partial-thickness burns are among the most frequently encountered types of burns , and numerous dressing materials are available for their treatment .
BACKGROUND	A multicenter , open , randomized , and parallel study was undertaken to determine the efficacy and tolerability of silver sulfadiazine ( SSD ) compared with an absorbent foam silver dressing , Mepilex Ag , on patients aged between 5 years and 65 years with deep partial-thickness thermal burn injuries ( 2.5-25 % total body surface area ) .
METHODS	Patients were randomly assigned to either SSD ( n = 82 ) applied daily or a Mepilex Ag dressing ( n = 71 ) applied every 5 days to 7 days .
METHODS	The treatment period was up to 4 weeks .
RESULTS	There was no significant difference between the two treatment groups with respect to the primary end point of time to healing , which occurred in 56 ( 79 % ) of 71 patients after a median follow-up time of 15 days in the Mepilex Ag group compared with 65 ( 79 % ) of 82 patients after a median follow-up time of 16 days in the SSD group ( p = 0.74 ) .
RESULTS	There was also no significant difference in the percentage of study burn healed .
RESULTS	Patients in the Mepilex Ag group had 87.1 % of their study burn healed ( out of the total burn area ) compared with 85.2 % of patients in the SSD group .
RESULTS	However , the mean total number of dressings used was significantly more in the SSD group ( 14.0 ) compared with the Mepilex Ag group ( 3.06 , p < 0.0001 ) .
RESULTS	There was no significant difference in the time until skin graft was performed between the two study groups .
CONCLUSIONS	There was no difference in healing rates between Mepilex Ag and SSD , with both products well tolerated .
CONCLUSIONS	The longer wear time of Mepilex Ag promotes undisturbed healing and makes it easier for patients to continue with their normal lives sooner .
METHODS	Therapeutic study , level III .

###24684813
BACKGROUND	In incomplete spinal cord injury ( iSCI ) , sensorimotor impairments result in severe limitations to ambulation .
BACKGROUND	To improve walking capacity , physical therapies using robotic-assisted locomotor devices , such as the Lokomat , have been developed .
BACKGROUND	Following locomotor training , an improvement in gait capabilities-characterized by increases in the over-ground walking speed and endurance-is generally observed in patients .
BACKGROUND	To better understand the mechanisms underlying these improvements , we studied the effects of Lokomat training on impaired ankle voluntary movement , known to be an important limiting factor in gait for iSCI patients .
METHODS	Fifteen chronic iSCI subjects performed twelve 1-hour sessions of Lokomat training over the course of a month .
METHODS	The voluntary movement was qualified by measuring active range of motion , maximal velocity peak and trajectory smoothness for the spastic ankle during a movement from full plantar-flexion ( PF ) to full dorsi-flexion ( DF ) at the patient 's maximum speed .
METHODS	Dorsi - and plantar-flexor muscle strength was quantified by isometric maximal voluntary contraction ( MVC ) .
METHODS	Clinical assessments were also performed using the Timed Up and Go ( TUG ) , the 10-meter walk ( 10MWT ) and the 6-minute walk ( 6MWT ) tests .
METHODS	All evaluations were performed both before and after the training and were compared to a control group of fifteen iSCI patients .
RESULTS	After the Lokomat training , the active range of motion , the maximal velocity , and the movement smoothness were significantly improved in the voluntary movement .
RESULTS	Patients also exhibited an improvement in the MVC for their ankle dorsi - and plantar-flexor muscles .
RESULTS	In terms of functional activity , we observed an enhancement in the mobility ( TUG ) and the over-ground gait velocity ( 10MWT ) with training .
RESULTS	Correlation tests indicated a significant relationship between ankle voluntary movement performance and the walking clinical assessments .
CONCLUSIONS	The improvements of the kinematic and kinetic parameters of the ankle voluntary movement , and their correlation with the functional assessments , support the therapeutic effect of robotic-assisted locomotor training on motor impairment in chronic iSCI .

###25365134
BACKGROUND	Although lateral ankle sprains are common in athletes and can lead to chronic ankle instability ( CAI ) , strength-training rehabilitation protocols may improve the deficits often associated with CAI .
OBJECTIVE	To determine whether strength-training protocols affect strength , dynamic balance , functional performance , and perceived instability in individuals with CAI .
METHODS	Randomized controlled trial .
METHODS	Athletic training research laboratory .
METHODS	A total of 39 individuals with CAI ( 17 men [ 44 % ] , 22 women [ 56 % ] ) participated in this study .
METHODS	Chronic ankle instability was determined by the Identification of Functional Ankle Instability Questionnaire , and participants were randomly assigned to a resistance-band-protocol group ( n = 13 [ 33 % ] age = 19.7 2.2 years , height = 172.9 12.8 cm , weight = 69.1 13.5 kg ) , a proprioceptive neuromuscular facilitation strength-protocol group ( n = 13 [ 33 % ] , age = 18.9 1.3 years , height = 172.5 5.9 cm , weight = 72.7 14.6 kg ) , or a control group ( n = 13 [ 33 % ] , age = 20.5 2.1 years , height = 175.2 8.1 cm , weight = 70.2 11.1 kg ) .
METHODS	Both rehabilitation groups completed their protocols 3 times/wk for 6 weeks .
METHODS	The control group did not attend rehabilitation sessions .
METHODS	Before the interventions , participants were pretested by completing the figure-8 hop test for time , the triple-crossover hop test for distance , isometric strength tests ( dorsiflexion , plantar flexion , inversion , and eversion ) , the Y-Balance test , and the visual analog scale for perceived ankle instability .
METHODS	Participants were again tested 6 weeks later .
METHODS	We conducted 2 separate , multivariate , repeated-measures analyses of variance , followed by univariate analyses on any significant findings .
RESULTS	The resistance-band protocol group improved in strength ( dorsiflexion , inversion , and eversion ) and on the visual analog scale ( P < .05 ) ; the proprioceptive neuromuscular facilitation group improved in strength ( inversion and eversion ) and on the visual analog scale ( P < .05 ) as well .
RESULTS	No improvements were seen in the triple-crossover hop or the Y-Balance tests for either intervention group or in the control group for any dependent variable ( P > .05 ) .
CONCLUSIONS	Although the resistance-band protocol is common in rehabilitation , the proprioceptive neuromuscular facilitation strength protocol is also an effective treatment to improve strength in individuals with CAI .
CONCLUSIONS	Both protocols showed clinical benefits in strength and perceived instability .
CONCLUSIONS	To improve functional outcomes , clinicians should consider using additional multiplanar and multijoint exercises .

###24552647
OBJECTIVE	Epidemiologic and biological evidence supports an inverse association between polyphenol consumption and the risk of cardiovascular disease ( CVD ) .
OBJECTIVE	However , no previous studies have prospectively evaluated the relationship between polyphenol intake and the incidence of CVD in such a comprehensive way .
OBJECTIVE	The aim was to evaluate the association between intakes of total polyphenol and polyphenol subgroups , and the risk of major cardiovascular events ( myocardial infarction , stroke or death from cardiovascular causes ) in the PREDIMED study .
RESULTS	The present work is an observational study within the PREDIMED trial .
RESULTS	Over an average of 4.3 years of follow-up , there were 273 confirmed cases of CVD among the 7172 participants ( 96.3 % ) who completed a validated 137-item food frequency questionnaire ( FFQ ) at baseline .
RESULTS	Polyphenol consumption was calculated by matching food consumption data from the FFQ with the Phenol-Explorer database on polyphenol content of each reported food .
RESULTS	After multivariate adjustment , a 46 % reduction in risk of CVD risk was observed comparing Q5 vs. Q1 of total polyphenol intake ( HR = 0.54 ; 95 % confidence interval [ CI ] = 0.33-0 .91 ; P-trend = 0.04 ) .
RESULTS	The polyphenols with the strongest inverse associations were flavanols ( HR = 0.40 ; CI 0.23-0 .72 ; P-trend = 0.003 ) , lignans ( HR = 0.51 ; CI 0.30-0 .86 ; P-trend = 0.007 ) , and hydroxybenzoic acids ( HR = 0.47 ; CI 0.26-0 .86 ; P-trend 0.02 ) .
CONCLUSIONS	Greater intake of polyphenols , especially from lignans , flavanols , and hydroxybenzoic acids , was associated with decreased CVD risk .
CONCLUSIONS	Clinical trials are needed to confirm this effect and establish accurate dietary recommendations .

###24913266
BACKGROUND	Inhaled therapies reduce risk of chronic obstructive pulmonary disease ( COPD ) exacerbations , but their effect on mortality is less well established .
BACKGROUND	We hypothesized that heterogeneity in baseline mortality risk influenced the results of drug trials assessing mortality in COPD .
METHODS	The 5706 patients with COPD from the Understanding Potential Long-term Impacts on Function with Tiotropium ( UPLIFT ) study that had complete clinical information for variables associated with mortality ( age , forced expiratory volume in 1s , St George 's Respiratory Questionnaire , pack-years and body mass index ) were classified by cluster analysis .
METHODS	Baseline risk of mortality between clusters , and impact of tiotropium were evaluated during the 4-yr follow up .
RESULTS	Four clusters were identified , including low-risk ( low mortality rate ) patients ( n = 2339 ; 41 % ; cluster 2 ) , and high-risk patients ( n = 1022 ; 18 % ; cluster 3 ) , who had a 2.6 - and a six-fold increase in all-cause and respiratory mortality compared with cluster 2 , respectively .
RESULTS	Tiotropium reduced exacerbations in all clusters , and reduced hospitalizations in high-risk patients ( p < 0.05 ) .
RESULTS	The beneficial effect of tiotropium on all-cause mortality in the overall population ( hazard ratio , 0.87 ; 95 % confidence interval , 0.75-1 .00 , p = 0.054 ) was explained by a 21 % reduction in cluster 3 ( p = 0.07 ) , with no effect in other clusters .
CONCLUSIONS	Large variations in baseline risks of mortality existed among patients in the UPLIFT study .
CONCLUSIONS	Inclusion of numerous low-risk patients may have reduced the ability to show beneficial effect on mortality .
CONCLUSIONS	Future clinical trials should consider selective inclusion of high-risk patients .

###25525171
OBJECTIVE	To investigate the safety and effects of intravitreal sirolimus for the potential treatment of geographic atrophy ( GA ) .
METHODS	The study was a single-center , open-label , phase I/II trial enrolling six participants with bilateral GA treated with intravitreal sirolimus in only one randomly assigned eye , with the fellow eye as control .
METHODS	The primary efficacy outcome measure was the change in total GA area from baseline on color fundus photography ( CFP ) ; secondary outcomes included changes in GA area on fundus autofluorescence ( FAF ) , visual acuity , central retinal thickness ( CRT ) , and macular sensitivity from baseline .
RESULTS	Although no systemic adverse events were attributed to treatment , two of six participants had ocular adverse events that were possibly associated .
RESULTS	The treated eye of one participant developed abnormal paralesional changes on FAF that were associated with accelerated retinal thinning .
RESULTS	This accelerated retinal thinning was also seen in the treated eye of a second participant .
RESULTS	Because of concern that these events were associated with treatment , treatment was suspended .
RESULTS	Comparisons of treated and fellow eyes for change in visual acuity , change in GA area , and change in CRT showed no evidence of treatment benefit and generally favored the untreated fellow eye .
CONCLUSIONS	While paralesional FAF changes and rapid retinal thinning observed are potentially part of the natural course of GA , they may possibly be related to treatment .
CONCLUSIONS	No general evidence of anatomical or functional benefit was detected in treated eyes .
CONCLUSIONS	Further data on intravitreal sirolimus for GA treatment will be available from a larger phase II trial .
CONCLUSIONS	( ClinicalTrials.gov number , NCT01445548 . )

###24550378
BACKGROUND	Invasive candidiasis is the third most common bloodstream infection in the intensive care unit ( ICU ) and is associated with morbidity and mortality .
BACKGROUND	Prophylaxis and preemptive therapy are attractive strategies for this setting .
METHODS	We conducted a multicenter , randomized , double-blind , placebo-controlled trial of caspofungin as antifungal prophylaxis in 222 adults who were in the ICU for at least 3 days , were ventilated , received antibiotics , had a central line , and had 1 additional risk factor ( parenteral nutrition , dialysis , surgery , pancreatitis , systemic steroids , or other immunosuppressants ) .
METHODS	Subjects ' ( 1,3 ) -- d-glucan levels were monitored twice weekly .
METHODS	The primary endpoint was the incidence of proven or probable invasive candidiasis by EORTC/MSG criteria in patients who did not have disease at baseline .
METHODS	Patients who had invasive candidiasis were allowed to break the blind and receive preemptive therapy with caspofungin .
METHODS	The preemptive approach analysis included patients all patients who received study drug , including those positive at baseline .
RESULTS	The incidence of proven/probable invasive candidiasis in the placebo and caspofungin arms was 16.7 % ( 14/84 ) and 9.8 % ( 10/102 ) , respectively , for prophylaxis ( P = .14 ) , and 30.4 % ( 31/102 ) and 18.8 % ( 22/117 ) , respectively , for the preemptive approach ( P = .04 ) ; however , this analysis included patients with baseline disease .
RESULTS	There were no significant differences in the secondary endpoints of mortality , antifungal use , or length of stay .
RESULTS	There were no safety differences .
CONCLUSIONS	Caspofungin was safe and tended to reduce the incidence of invasive candidiasis when used for prophylaxis , but the difference was not statistically significant .
CONCLUSIONS	A preemptive therapy approach deserves further study .
BACKGROUND	NCT00520234 .

###24281563
BACKGROUND	Very few studies have investigated the effects of individual disorder-specific treatment of social phobia ( SP ) in adolescents .
BACKGROUND	The objective of this study was to compare the effects of individual cognitive therapy for SP , group cognitive behavioural therapy ( CBTG ) and attentional placebo ( AP ) among adolescents with a primary diagnosis of SP .
METHODS	A randomized controlled design was used , and a total of 279 adolescents were assessed .
METHODS	Fifty-seven adolescents , between 13 and 16 years old , were allocated to individual cognitive therapy , CBTG or AP .
METHODS	The participants were assessed before treatment , at the end of treatment and at a 12-month follow-up using both self-report and a semi-structured interview .
RESULTS	The individual cognitive therapy showed significant reductions in symptoms , impairment and diagnostic criteria both at the end of treatment and at the 12-month follow-up .
RESULTS	Compared with CBTG and AP , the individual cognitive therapy group demonstrated significantly greater effects on both symptom reduction and impairment .
RESULTS	There were no significant differences between CBTG and AP .
CONCLUSIONS	In a direct comparison between the most commonly used treatments for adolescent SP , we found that individual therapy was the most effective , yielding better effects than both CBTG and AP .

###25720616
OBJECTIVE	To assess the behavioral effects of receiving personal genetic information , using apoE genotypes as a tool for promoting lifestyle changes .
OBJECTIVE	apoE was chosen because it has a significant impact on lipid metabolism and cholesterol absorption , both factors in cardiovascular disease .
METHODS	This study was a 1-year intervention study of healthy adults aged 20-67 years ( n = 107 ) .
METHODS	Their behavioral changes were measured by diet ( e.g. , fat quality , as well as consumption of vegetables , berries , fruits , and fatty and sugary foods ) , alcohol consumption , and exercise .
METHODS	Health and taste attitudes were assessed with the Health and Taste Attitude Scales ( HTAS ) .
METHODS	The measurements were performed 4 times : at baseline ( T0 ) , as well as 10 weeks ( T1 ) , 6 months ( T2 ) , and 12 months after baseline ( T3 ) .
METHODS	These behavioral effects were assessed for three groups : a high-risk ( 4 + ; n = 16 ) , a low-risk ( 4 - ; n = 35 ) , and a control group ( n = 56 ) .
RESULTS	Personal genetic information affected health behavior .
RESULTS	Dietary fat quality improved more in the 4 + group than in the 4 - and control groups after personal , genotype-based health advice .
RESULTS	This change differed significantly between the 4 + and the control group ( p < 0.05 ) , but only for a short time .
CONCLUSIONS	Personal genetic information , based on apoE , may affect dietary fat quality .
CONCLUSIONS	More research is required to determine how to utilize genotype-based health information and how to efficiently achieve long-term changes in the prevention of lifestyle-related diseases .

###25512446
OBJECTIVE	To test the hypothesis that in very prematurely born infants remaining ventilated beyond the first week , proportional assist ventilation ( PAV ) compared with assist control ventilation ( ACV ) would be associated with reduced work of breathing , increased respiratory muscle strength and less ventilator-infant asynchrony which would be associated with improved oxygenation .
METHODS	Randomised crossover study .
METHODS	Tertiary neonatal unit .
METHODS	12 infants with a median gestational age of 25 ( range 24-26 ) weeks were studied at a median of 43 ( range 8-86 ) days .
METHODS	Infants were studied for 1h each on PAV and ACV in random order .
METHODS	At the end of each hour , the work of breathing ( assessed by measuring the diaphragmatic pressure time product ) , thoracoabdominal asynchrony and respiratory muscle strength ( maximal inspiratory pressure , maximal expiratory pressure ( Pemax ) and maximal transdiaphragmatic pressure ( Pdimax ) ) were assessed .
METHODS	Blood gas analysis was performed and the oxygenation index ( OI ) calculated .
RESULTS	After 1h on PAV compared with 1h on ACV , the median OI ( 5.55 ( range 5-11 ) vs 10.10 ( range 7-16 ) , p = 0.002 ) and PTP levels were lower ( 217 ( range 59-556 ) cmH2O.s / min vs 309 ( range 55-544 ) cmH2O.s / min , p = 0.005 ) , while Pdimax ( 44.26 ( range 21-66 ) cmH2O vs 37.9 ( range 19-45 ) cmH2O , p = 0.002 ) and Pemax ( 25.6 ( range 6.5-42 ) cmH2O vs 15.9 ( range 3-35 ) cmH2O levels p = 0.010 ) were higher .
CONCLUSIONS	These results suggest that PAV compared with ACV may have physiological advantages for prematurely born infants who remain ventilated after the first week after birth .

###24423407
BACKGROUND	The effects of tongue cleaning on reconstruction of bacterial flora in dental plaque and tongue coating itself are obscure .
BACKGROUND	We assessed changes in the amounts of total bacteria as well as Fusobacterium nucleatum in tongue coating and dental plaque specimens obtained with and without tongue cleaning .
METHODS	We conducted a randomized examiner-blind crossover study using 30 volunteers ( average 23.7 3.2 years old ) without periodontitis .
METHODS	After dividing randomly into 2 groups , 1 group was instructed to clean the tongue , while the other did not .
METHODS	On days 1 ( baseline ) , 3 , and 10 , tongue coating and dental plaque samples were collected after recording tongue coating score ( Winkel tongue coating index : WTCI ) .
METHODS	After a washout period of 3 weeks , the same examinations were performed with the subjects allocated to the alternate group .
METHODS	Genomic DNA was purified from the samples and applied to SYBR Green-based real-time PCR to quantify the amounts of total bacteria and F. nucleatum .
RESULTS	After 3 days , the WTCI score recovered to baseline , though the amount of total bacteria in tongue coating was significantly lower as compared to the baseline .
RESULTS	In plaque samples , the bacterial amounts on day 3 and 10 were significantly lower than the baseline with and without tongue cleaning .
RESULTS	Principal component analysis showed that variations of bacterial amounts in the tongue coating and dental plaque samples were independent from each other .
RESULTS	Furthermore , we found a strong association between amounts of total bacteria and F. nucleatum in specimens both .
CONCLUSIONS	Tongue cleaning reduced the amount of bacteria in tongue coating .
CONCLUSIONS	However , the cleaning had no obvious contribution to inhibit dental plaque formation .
CONCLUSIONS	Furthermore , recovery of the total bacterial amount induced an increase in F. nucleatum in both tongue coating and dental plaque .
CONCLUSIONS	Thus , it is recommended that tongue cleaning and tooth brushing should both be performed for promoting oral health .

###26014292
OBJECTIVE	Given concerns that dexrazoxane may reduce treatment efficacy , induce second cancers , and thus compromise overall survival among children , we examined long-term overall and cause-specific mortality and disease relapse rates from three randomized clinical trials .
METHODS	Children 's Oncology Group trials P9404 ( T-cell acute lymphoblastic leukemia/lymphoma ; n = 537 ) , P9425 ( intermediate/high-risk Hodgkin lymphoma ; n = 216 ) , and P9426 ( low-risk Hodgkin lymphoma ; n = 255 ) were conducted between 1996 and 2001 .
METHODS	Each trial randomly assigned patients to doxorubicin with or without dexrazoxane .
METHODS	The dexrazoxane : doxorubicin dose ratio was 10:1 , and the cumulative protocol-specified doxorubicin dose was 100 to 360 mg/m ( 2 ) .
METHODS	Dexrazoxane was given as an intravenous bolus before each doxorubicin dose .
METHODS	Data from all three trials were linked with the National Death Index to determine overall and cause-specific mortality by dexrazoxane status .
RESULTS	Among 1,008 patients ( 507 received dexrazoxane ) with a median follow-up of 12.6 years ( range , 0 to 15.5 years ) , 132 died ( 67 received dexrazoxane ) .
RESULTS	Overall mortality did not vary by dexrazoxane status ( 12.8 % with dexrazoxane at 10 years v 12.2 % without ; hazard ratio [ HR ] , 1.03 ; 95 % CI , 0.73 to 1.45 ) .
RESULTS	Findings were similar when each trial was examined separately .
RESULTS	Dexrazoxane also was not significantly associated with differential causes of death .
RESULTS	The original cancer caused 76.5 % of all deaths ( HR , 0.90 ; 95 % CI , 0.61 to 1.32 ) followed by second cancers ( 13.6 % of deaths ; HR , 1.24 ; 95 % CI , 0.49 to 3.15 ) .
RESULTS	Specifically , dexrazoxane was not associated with deaths from acute myeloid leukemia/myelodysplasia or cardiovascular events .
CONCLUSIONS	Among pediatric patients with leukemia or lymphoma , after extended follow-up , dexrazoxane use did not seem to compromise long-term survival .

###24247229
BACKGROUND	Scholarly activity is expected of program directors of Accreditation Council for Graduate Medical Education ( ACGME ) - accredited residency training programs .
BACKGROUND	Anesthesiology residency programs are cited more often than surgical programs for deficiencies in academic productivity .
BACKGROUND	We hypothesized that this may in part reflect differences in scholarly activity between program directors of anesthesiology and surgical trainings programs .
BACKGROUND	To test the hypothesis , we examined the career track record of current program directors of ACGME-accredited anesthesiology and surgical residency programs at the same institutions using PubMed citations and funding from the National Institutes of Health ( NIH ) as metrics of scholarly activity .
METHODS	Between November 1 , 2011 and December 31 , 2011 , we obtained data from publicly available Web sites on program directors at 127 institutions that had ACGME-accredited programs in both anesthesiology and surgery .
METHODS	Information gathered on each individual included year of board certification , year first appointed program director , academic rank , history of NIH grant funding , and number of PubMed citations .
METHODS	We also calculated the h-index for a randomly selected subset of 25 institution-matched program directors .
RESULTS	There were no differences between the groups in number of years since board certification ( P = 0.42 ) , academic rank ( P = 0.38 ) , or years as a program director ( P = 0.22 ) .
RESULTS	However , program directors in anesthesiology had less prior or current NIH funding ( P = 0.002 ) , fewer total and education-related PubMed citations ( both P < 0.001 ) , and a lower h-index ( P = 0.001 ) than surgery program directors .
RESULTS	Multivariate analysis revealed that the publication rate for anesthesiology program directors was 43 % ( 95 % confidence interval , 0.31-0 .58 ) that of the corresponding program directors of surgical residency programs , holding other variables constant .
CONCLUSIONS	Program directors of anesthesiology residency programs have considerably less scholarly activity in terms of peer-reviewed publications and federal research funding than directors of surgical residency programs .
CONCLUSIONS	As such , this study provides further evidence for a systemic weakness in the scholarly fabric of academic anesthesiology .

###24678906
BACKGROUND	In recent years , several oral antidiabetic drugs with new mechanisms of action have become available , expanding the number of treatment options .
BACKGROUND	Sodium/glucose cotransporter-2 ( SGLT2 ) inhibitors are a new class of oral antidiabetic drugs with an insulin-independent mechanism promoting urinary glucose excretion .
BACKGROUND	We report the results of a combined Phase 2 and 3 clinical study ( Japic CTI-101349 ) of the SGLT2 inhibitor tofogliflozin ( CSG452 , RG7201 ) in Japanese patients with type 2 diabetes mellitus .
METHODS	The efficacy and safety of tofogliflozin were assessed in this multicenter , placebo-controlled , randomized , double-blind parallel-group study involving 230 patients with type 2 diabetes mellitus with inadequate glycemic control on diet/exercise therapy .
METHODS	Between 30 October 2010 and 28 February 2012 , patients at 33 centers were randomized to either placebo ( n = 56 ) or tofogliflozin ( 10 , 20 , or 40 mg ; n = 58 each ) orally , once daily for 24 weeks .
METHODS	The primary efficacy endpoint was the change from baseline in HbA1c at week 24 .
RESULTS	Overall , 229 patients were included in the full analysis set ( placebo : n = 56 ; tofogliflozin 10 mg : n = 57 ; tofogliflozin 20 and 40 mg : n = 58 each ) .
RESULTS	The least squares ( LS ) mean change ( 95 % confidence interval ) from baseline in HbA1c at week 24 was -0.028 % ( -0.192 to 0.137 ) in the placebo group , compared with -0.797 % ( -0.960 to -0.634 ) in the tofogliflozin 10 mg group , -1.017 % ( -1.178 to -0.856 ) in the tofogliflozin 20 mg group , and -0.870 % ( -1.031 to -0.709 ) in the tofogliflozin 40 mg group ( p < 0.0001 for the LS mean differences in all tofogliflozin groups vs placebo ) .
RESULTS	There were also prominent decreases in fasting blood glucose , 2-h postprandial glucose , and body weight in all tofogliflozin groups compared with the placebo group .
RESULTS	The main adverse events were hyperketonemia , ketonuria , and pollakiuria .
RESULTS	The incidence of hypoglycemia was low .
RESULTS	Furthermore , most adverse events were classified as mild or moderate in severity .
CONCLUSIONS	Tofogliflozin 10 , 20 , or 40 mg administered once daily as monotherapy significantly decreased HbA1c and body weight , and was generally well tolerated in Japanese patients with type 2 diabetes mellitus .
CONCLUSIONS	Phase 3 studies were recently completed and support the findings of this combined Phase 2 and 3 study .
BACKGROUND	This study was registered in the JAPIC clinical trials registry ( ID : Japic CTI-101349 ) .

###25438529
OBJECTIVE	To observe the effects of daily consumption of milk powder on Healthy young women , including the effect on menstrual cycles , ovulation time and sex hormone concentrations in morning urine .
METHODS	Thirty-two young women were recruited as subjects and randomly assigned into two groups for a milk powder consumption experiment which lasted three menstrual cycles .
METHODS	The first menstrual cycle is control cycle , the second menstrual cycle is milk-taking cycle .
METHODS	The subjects take milk diluted by 33g or 55g milk powder each day , from the 4th to the 24th day of the second menstrual cycle .
METHODS	The third menstrual cycles is control cycle after milk-taking .
METHODS	During the whole three menstrual cycle , record the length of each menstrual cycle , determine ovulation time by using basal body temperature and oviposit test paper , collect their morning urine samples at specified times ( the 4th , 7th , 10th , 13rd , 16th , 19th and 24th day of first and the third menstrual cycle ; the 4th , 5th , 6th , 7th , 9th , 12nd , 15th , 18th , 21st and 24th day of the second menstrual cycle ) , determine the concentrations of estradiol , pregnanediol and creatinine in morning urine samples ; draw the curve of the concentration changing over time and calculate the area under the curve to the 24th day .
RESULTS	In the high-dose group , the mean of the menstrual cycle length are ( 29.60 3.180 ) d , ( 28.87 3.021 ) d , ( 29.60 2.995 ) d , the mean of the ovulation time are ( 15.47 2.200 ) d.
RESULTS	There was no significant difference in menstrual cycle length and ovulation time among cycles and between groups ( P > 0.05 ) .
RESULTS	Calculate the difference between the first and the second menstrual cycle , and the difference between the two groups .
RESULTS	In the high-dose group , the area under the curve of estradiol concentrations adjusted by creatinine are ( 7160.28 2305.52 ) , ( 6700.26 2066.67 ) ; ( 6676.24 2573.89 ) ; the area under the curve of pregnanediol concentrations corrected by creatinine are ( 51.93 18.80 ) , ( 44.55 14.62 ) and ( 46.49 22.44 ) .
RESULTS	In the low-dose group , the area under the curve of estradiol concentrations adjusted by creatinine are ( 6838.21 2573.89 ) , ( 6611.33 1648.21 ) and ( 5949.24 1437.54 ) / The area under the curve of pregnanediol concentrations adjusted by creatinine are ( 49.25 15.68 ) , ( 48.79 15.61 ) and ( 43.45 12.77 ) .
RESULTS	Theres no significant difference of the area under the curve among three menstrual cycles and between two groups ( P > 0.05 ) .
CONCLUSIONS	21 days continuous daily consumption of milk powder does not have a significant impact on menstrual cycle , or on the estradiol/pregnanediol concentrations in morning urine .

###24589310
BACKGROUND	Single-pass , contrast-enhanced whole body multidetector computed tomography ( MDCT ) emerged as the diagnostic standard for evaluating patients with major trauma .
BACKGROUND	Modern iterative image algorithms showed high image quality at a much lower radiation dose in the non-trauma setting .
BACKGROUND	This study aims at investigating whether the radiation dose can safely be reduced in trauma patients without compromising the diagnostic accuracy and image quality .
METHODS	Prospective observational study with two consecutive cohorts of patients .
METHODS	A high-volume , academic , supra-regional trauma centre in Germany .
METHODS	Consecutive male and female patients who 1 .
METHODS	had been exposed to a high-velocity trauma mechanism , 2 .
METHODS	present with clinical evidence or high suspicion of multiple trauma ( predicted Injury Severity Score [ ISS ] 16 ) and 3 .
METHODS	are scheduled for primary MDCT based on the decision of the trauma leader on call.Imaging protocols : In a before/after design , a consecutive series of 500 patients will undergo single-pass , whole-body 128-row multi-detector computed tomography ( MDCT ) with a standard , as low as possible radiation dose .
METHODS	This will be followed by a consecutive series of 500 patients undergoing an approved ultra-low dose MDCT protocol using an image processing algorithm .
METHODS	Routine administrative data and electronic patient records , as well as digital images stored in a picture archiving and communications system will serve as the primary data source .
METHODS	The protocol was approved by the institutional review board .
RESULTS	( 1 ) incidence of delayed diagnoses , ( 2 ) diagnostic accuracy , as correlated to the reference standard of a synopsis of all subsequent clinical , imaging , surgical and autopsy findings , ( 3 ) patients ' safety , ( 4 ) radiation exposure ( e.g. effective dose ) , ( 5 ) subjective image quality ( assessed independently radiologists and trauma surgeons on a 100-mm visual analogue scale ) , ( 6 ) objective image quality ( e.g. , contrast-to-noise ratio ) .
METHODS	Multivariate regression will be employed to adjust and correct the findings for time and cohort effects .
METHODS	An exploratory interim analysis halfway after introduction of low-dose MDCT will be conducted to assess whether this protocol is clearly inferior or superior to the current standard .
CONCLUSIONS	Although non-experimental , this study will generate first large-scale data on the utility of imaging-enhancing algorithms in whole-body MDCT for major blunt trauma .
BACKGROUND	Current Controlled Trials ISRCTN74557102 .

###25257633
BACKGROUND	Little is known about the incidence of prosthesis-patient mismatch ( PPM ) and its impact on outcomes after transcatheter aortic valve replacement ( TAVR ) .
OBJECTIVE	The objectives of this study were : 1 ) to compare the incidence of PPM in the TAVR and surgical aortic valve replacement ( SAVR ) randomized control trial ( RCT ) arms of the PARTNER ( Placement of AoRTic TraNscathetER Valves ) I Trial cohort A ; and 2 ) to assess the impact of PPM on regression of left ventricular ( LV ) hypertrophy and mortality in these 2 arms and in the TAVR nonrandomized continued access ( NRCA ) registry cohort .
METHODS	The PARTNER Trial cohort A randomized patients 1:1 to TAVR or bioprosthetic SAVR .
METHODS	Postoperative PPM was defined as absent if the indexed effective orifice area ( EOA ) was > 0.85 cm ( 2 ) / m ( 2 ) , moderate if the indexed EOA was 0.65 but 0.85 cm ( 2 ) / m ( 2 ) , or severe if the indexed EOA was < 0.65 cm ( 2 ) / m ( 2 ) .
METHODS	LV mass regression and mortality were analyzed using the SAVR-RCT ( n = 270 ) , TAVR-RCT ( n = 304 ) , and TAVR-NRCA ( n = 1,637 ) cohorts .
RESULTS	The incidence of PPM was 60.0 % ( severe : 28.1 % ) in the SAVR-RCT cohort versus 46.4 % ( severe : 19.7 % ) in the TAVR-RCT cohort ( p < 0.001 ) and 43.8 % ( severe : 13.6 % ) in the TAVR-NRCA cohort .
RESULTS	In patients with an aortic annulus diameter < 20 mm , severe PPM developed in 33.7 % undergoing SAVR compared with 19.0 % undergoing TAVR ( p = 0.002 ) .
RESULTS	PPM was an independent predictor of less LV mass regression at 1 year in the SAVR-RCT ( p = 0.017 ) and TAVR-NRCA ( p = 0.012 ) cohorts but not in the TAVR-RCT cohort ( p = 0.35 ) .
RESULTS	Severe PPM was an independent predictor of 2-year mortality in the SAVR-RCT cohort ( hazard ratio [ HR ] : 1.78 ; p = 0.041 ) but not in the TAVR-RCT cohort ( HR : 0.58 ; p = 0.11 ) .
RESULTS	In the TAVR-NRCA cohort , severe PPM was not a predictor of 1-year mortality in all patients ( HR : 1.05 ; p = 0.60 ) but did independently predict mortality in the subset of patients with no post-procedural aortic regurgitation ( HR : 1.88 ; p = 0.02 ) .
CONCLUSIONS	In patients with severe aortic stenosis and high surgical risk , PPM is more frequent and more often severe after SAVR than TAVR .
CONCLUSIONS	Patients with PPM after SAVR have worse survival and less LV mass regression than those without PPM .
CONCLUSIONS	Severe PPM also has a significant impact on survival after TAVR in the subset of patients with no post-procedural aortic regurgitation .
CONCLUSIONS	TAVR may be preferable to SAVR in patients with a small aortic annulus who are susceptible to PPM to avoid its adverse impact on LV mass regression and survival .
CONCLUSIONS	( The PARTNER Trial : Placement of AoRTic TraNscathetER Valve Trial ; NCT00530894 ) .

###25608747
OBJECTIVE	The purpose of our study was to determine whether sex affects the predictive value of perfusion and wall motion imaging obtained with real time myocardial contrast echocardiography ( RTMCE ) when compared with conventional stress echocardiography ( CSE ) .
METHODS	We prospectively enrolled 1649 age-matched men and women with intermediate pretest probability of coronary artery disease ( CAD ) undergoing stress echocardiography for suspicion of CAD .
METHODS	Patients with known CAD were excluded .
METHODS	Those who consented to participate in the study were randomised to undergo either CSE or RTMCE .
METHODS	Events were defined as death , non-fatal myocardial infarction ( MI ) and need for revascularisation .
RESULTS	Median follow-up was 2.6 years ( 927 women , 722 men ) .
RESULTS	Mean age was 5813years in both sexes .
RESULTS	There were a total of 62 deaths , 12 MIs and 85 revascularisations with a 2-year event rate of 3.5 % ( 95 % CI 2.7 % to 4.7 % ) .
RESULTS	Male sex was a significant independent predictor of adverse outcome ( death , non-fatal MI ) in both CSE and RTMCE ( CSE HR 2.07 , 95 % CI 1.07 to 4.02 , RTMCE HR 2.14 ; 95 % CI 1.04 to 4.33 ) .
RESULTS	Higher 2-year event rates were noted in men in comparison with women after a normal CSE ( men 5.4 % , women 1.6 % , p = 0.02 ) , but not after a normal RTMCE ( men 5.8 % , women 3.7 % , p = 0.41 ) .
RESULTS	Event rates were also significantly higher in men after an abnormal RTMCE ( men 34.8 % , women 16.4 % , p = 0.02 ) but no difference in outcome between sexes was observed after an abnormal CSE ( men 17.8 % , women 18.6 % , p = 0.90 ) .
CONCLUSIONS	The addition of perfusion imaging with RTMCE improves the predictive value of stress echocardiography in men with no known CAD , but does not improve the predictive value in age-matched women .

###24393750
OBJECTIVE	To compare effects of raisin snacks with conventional snacks on glycemia and cardiovascular risk factors .
METHODS	A 12-week , randomized , controlled trial compared 3-times-a-day consumption of raisins with intake of processed snacks on glycemia and cardiovascular risk factors .
METHODS	Men and women were randomized to snacks ( n = 15 ) or raisins ( n = 31 ) .
METHODS	Outcome measures were performed at baseline , 4 , 8 , and 12 weeks .
RESULTS	Fasting plasma glucose levels were not significantly affected by intake of raisins or snacks .
RESULTS	Mean subject post prandial glucose levels were significantly reduced by raisin intake at 12 weeks ; changes with raisin intake were -13.1 mg/dL ( P = 0.003 vs baseline ; P = 0.03 vs snacks ) .
RESULTS	Eating raisins significantly decreased glycated hemoglobin ( HbA1c ) level ( -0.12 % ; P = 0.004 ) , a significantly greater level decrease than seen with snack intake ( P = 0.036 ) .
RESULTS	Snack intake did not significantly affect subject systolic or diastolic blood pressure ( BP ) .
RESULTS	Raisin intake was associated with reductions in systolic blood pressure ( SBP ) at 4 , 8 , and 12 weeks with mean changes of -6.0 to 10.2 mmHg ; all these changes were statistically significant ( P = 0.015 to 0.001 ) .
RESULTS	Raisins were associated with significantly greater changes in diastolic blood pressure ( DBP ) at 4 , 8 , and 12 weeks than snacks ( P < 0.05 ) .
RESULTS	Body weight did not significantly change within or between groups .
CONCLUSIONS	Regular consumption of raisins may reduce glycemia and cardiovascular risk factors , including BP rate .

###24481828
BACKGROUND	Previous studies have shown improvement in patellar tendinopathy symptoms after platelet-rich plasma ( PRP ) injections , but no randomized controlled trial has compared PRP with dry needling ( DN ) for this condition .
OBJECTIVE	To compare clinical outcomes in patellar tendinopathy after a single ultrasound-guided , leukocyte-rich PRP injection versus DN .
METHODS	Randomized controlled trial ; Level of evidence , 1 .
METHODS	A total of 23 patients with patellar tendinopathy on examination and MRI who had failed nonoperative treatment were enrolled and randomized to receive ultrasound-guided DN alone ( DN group ; n = 13 ) or with injection of leukocyte-rich PRP ( PRP group ; n = 10 ) , along with standardized eccentric exercises .
METHODS	Patients and the physician providing follow-up care were blinded .
METHODS	Participants completed patient-reported outcome surveys before and at 3 , 6 , 9 , 12 , and 26 weeks after treatment during follow-up visits .
METHODS	The primary outcome measure was the Victorian Institute of Sports Assessment ( VISA ) score for patellar tendinopathy at 12 weeks , and secondary measures included the visual analog scale ( VAS ) for pain , Tegner activity scale , Lysholm knee scale , and Short Form ( SF-12 ) questionnaire at 12 and 26 weeks .
METHODS	Results were analyzed using 2-tailed paired and unpaired t tests .
METHODS	Patients who were dissatisfied at 12 weeks were allowed to cross over into a separate unblinded arm .
RESULTS	At 12 weeks after treatment , VISA scores improved by a mean standard deviation of 5.2 12.5 points ( P = .20 ) in the DN group ( n = 12 ) and by 25.4 23.2 points ( P = .01 ) in the PRP group ( n = 9 ) ; at 26 weeks , the scores improved by 33.2 14.0 points ( P = .001 ) in the DN group ( n = 9 ) and by 28.9 25.2 points ( P = .01 ) in the PRP group ( n = 7 ) .
RESULTS	The PRP group had improved significantly more than the DN group at 12 weeks ( P = .02 ) , but the difference between groups was not significant at 26 weeks ( P = .66 ) .
RESULTS	Lysholm scores were not significantly different between groups at 12 weeks ( P = .81 ) , but the DN group had improved significantly more than the PRP group at 26 weeks ( P = .006 ) .
RESULTS	At 12 weeks , 3 patients in the DN group failed treatment and subsequently crossed over into the PRP group .
RESULTS	These patients were excluded from the primary 26-week analysis .
RESULTS	There were no treatment failures in the PRP group .
RESULTS	No adverse events were reported .
RESULTS	Recruitment was stopped because interim analysis demonstrated statistically significant and clinically important results .
CONCLUSIONS	A therapeutic regimen of standardized eccentric exercise and ultrasound-guided leukocyte-rich PRP injection with DN accelerates the recovery from patellar tendinopathy relative to exercise and ultrasound-guided DN alone , but the apparent benefit of PRP dissipates over time .

###24494593
OBJECTIVE	To improve patient-centred care by determining the impact of baseline levels of conscientiousness and diabetes self-efficacy on the outcomes of efficacious interventions to reduce diabetes distress and improve disease management .
METHODS	Adults with Type 2 diabetes with diabetes distress and self-care problems ( N = 392 ) were randomized to one of three distress reduction interventions : computer-assisted self-management ; computer-assisted self-management plus problem-solving therapy ; and health education .
METHODS	The baseline assessment included conscientiousness and self-efficacy , demographics , diabetes status , regimen distress , emotional burden , medication adherence , diet and physical activity .
METHODS	Changes in regimen distress , emotional burden and self-care between baseline and 12 months were recorded and ancova models assessed how conscientiousness and self-efficacy qualified the significant improvements in distress and management outcomes .
RESULTS	Participants with high baseline conscientiousness displayed significantly larger improvements in medication adherence and emotional burden than participants with low baseline conscientiousness .
RESULTS	Participants with high baseline self-efficacy showed greater improvements in diet , physical activity and regimen distress than participants with low baseline self-efficacy .
RESULTS	The impact of conscientiousness and self-efficacy were independent of each other and occurred across all three intervention groups .
RESULTS	A significant interaction indicated that those with both high self-efficacy and high conscientiousness at baseline had the biggest improvement in physical activity by 12 months .
CONCLUSIONS	Both broad personal traits and disease-specific expectations qualify the outcomes of efficacious interventions .
CONCLUSIONS	These findings reinforce the need to change from a one-size-fits-all approach to diabetes interventions to an approach that crafts clinical interventions in ways that fit the personal traits and skills of individual people .

###24914425
OBJECTIVE	To determine the effect of mechanical tooth cleaning by toothbrush and dental floss on mutans streptococci in the saliva of preschool children .
METHODS	This blinded , randomised controlled clinical trial included 54 3-year-old preschool children with detectable mutans streptococci in saliva .
METHODS	The children were randomly divided into a test and a control group .
METHODS	Dental college students cleaned the teeth of test group participants with toothbrush and dental floss under the indication of a plaque disclosing agent once a day .
METHODS	The control group received no intervention .
METHODS	Dentocult SM Strip mutans ( D-SM ) strips were used to test the mutans streptococci in saliva .
RESULTS	The D-SM test scores declined from 1.82 to 0.95 for the test group after the teeth were cleaned 10 times ( P < 0.001 ) and the scores increased to 1.62 after tooth cleaning ceased for 2 weeks ( P > 0.05 compared with baseline ) .
RESULTS	The D-SM level of the control group did not change significantly .
CONCLUSIONS	Meticulous and continuous plaque control with toothbrush and dental floss can decrease the mutans streptococci level in preschool children .
CONCLUSIONS	However , the effect ceased as the intervention ceased .

###25531343
OBJECTIVE	Tenofovir disoproxil fumarate ( TDF ) use has been associated with declines in the estimated glomerular filtration rate ( eGFR ) when used as part of antiretroviral treatment by persons with human immunodeficiency virus ( HIV ) type 1 , but limited data are available for risk when used as preexposure prophylaxis ( PrEP ) for HIV-1 prevention .
OBJECTIVE	To determine whether TDF-based PrEP causes eGFR decline in HIV-1-uninfected adults .
METHODS	A per-protocol safety analysis of changes in eGFR in the Partners PrEP Study , a randomized , placebo-controlled trial of daily oral TDF and emtricitabine ( FTC ) - TDF PrEP among heterosexual HIV-1-uninfected members of serodiscordant couples in Kenya and Uganda .
METHODS	The trial was conducted from 2008 to 2012 .
METHODS	Predefined outcomes of this analysis were mean eGFR change and a 25 % or greater eGFR decline from baseline .
METHODS	The eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation .
RESULTS	Of 4640 participants in the once-daily TDF ( n = 1548 ) , FTC-TDF ( n = 1545 ) , or placebo ( n = 1547 ) groups , 63 % were men .
RESULTS	At enrollment , median age was 35 years ( range , 18-64 years ) , and mean eGFR was 130 mL/min/1 .73 m.
RESULTS	During a median follow-up of 18 months ( interquartile range 12-27 months ) , mean within-group eGFR change from baseline was +0.14 mL/min/1 .73 m for TDF , -0.22 mL/min/1 .73 m for FTC-TDF , and +1.37 mL/min/1 .73 m for placebo , translating into average declines in eGFR attributable to PrEP vs placebo of -1.23 mL/min/1 .73 m ( 95 % CI , -2.06 to -0.40 ; P = .004 ) for TDF and -1.59 mL/min/1 .73 m ( 95 % CI , -2.44 to -0.74 ; P < .001 ) for FTC-TDF .
RESULTS	The difference in mean eGFR between PrEP and placebo appeared by 1 month after randomization , was stable through 12 months , and then appeared to wane thereafter .
RESULTS	The respective proportions of persons who developed a confirmed 25 % or greater eGFR decline from baseline by 12 and 24 months was 1.3 % and 1.8 % for TDF and 1.2 % and 2.5 % for FTC-TDF , and these frequencies were not statistically different from the confirmed decline in the placebo group ( 0.9 % and 1.3 % by 12 and 24 months , respectively ) .
CONCLUSIONS	In this large randomized , placebo-controlled trial among heterosexual persons , with median follow-up of 18 months and maximum follow-up of 36 months , daily oral TDF-based PrEP resulted in a small but nonprogressive decline in eGFR that was not accompanied by a substantial increase in the risk of clinically relevant ( 25 % ) eGFR decline .
BACKGROUND	clinicaltrials.gov Identifier : NCT00557245 .

###26299226
BACKGROUND	Patients hospitalized for acute decompensated heart failure ( ADHF ) are at high risk for early mortality and rehospitalization .
BACKGROUND	Risk stratification of ADHF using clinically available data on admission is increasingly important to integrate with clinical pathways .
BACKGROUND	Our goal was to create a simple method of screening patients upon admission to identify those with increased risk of future adverse events .
METHODS	Using ASCEND-HF , a pragmatic clinical trial conducted in 398 sites globally , we developed and validated logistic regression risk models for ( a ) 30-day mortality/HF rehospitalization , ( b ) 30-day mortality/all-cause rehospitalization , ( c ) 30-day all-cause mortality , and ( d ) 180-day all-cause mortality .
METHODS	Fifty-one candidate variables were evaluated based on prior publications and clinical review .
METHODS	Final models were selected based on stepwise selection with entry and a staying criterion of P < .01 .
METHODS	The 30-day mortality model was externally validated , and coefficients were converted to an additive risk score .
RESULTS	Among 7,141 patients , the median age was 67 years , 34 % were female , and 80 % had a left ventricular ejection fraction < 40 % .
RESULTS	The models had between 5 and 12 risk factors with c-indices ranging from 0.68 to 0.75 .
RESULTS	A simplified score , including age , systolic blood pressure , sodium , blood urea nitrogen , and dyspnea at rest , discriminated 30-day mortality risk from 0.5 % ( score 0 ) to 53 % ( score 10 ) .
CONCLUSIONS	Commonly available clinical variables provide simple risk stratification for clinical outcomes among patients with ADHF , and these models may be considered for integration into routine clinical care .

###25205868
OBJECTIVE	Ciliary neurotrophic factor ( CNTF ) protects rod photoreceptors from retinal degenerative disease in multiple nonhuman models .
OBJECTIVE	Thus far , CNTF has failed to demonstrate rod protection in trials for human retinitis pigmentosa .
OBJECTIVE	Recently , CNTF was found to improve cone photoreceptor function in a canine CNGB3 achromatopsia model .
OBJECTIVE	This study explores whether this finding translates to humans with CNGB3 achromatopsia .
METHODS	A five-subject , open-label Phase I/II study was initiated by implanting intraocular microcapsules releasing CNTF ( nominally 20 ng/d ) into one eye each of CNGB3 achromat participants .
METHODS	Fellow eyes served as untreated controls .
METHODS	Subjects were followed for 1 year .
RESULTS	Pupil constriction in treated eyes gave evidence of intraocular CNTF release .
RESULTS	Additionally , scotopic ERG responses were reduced , and dark-adapted psychophysical absolute thresholds were increased , attributable to diminished rod or rod pathway activity .
RESULTS	Optical coherence tomography revealed that the cone-rich fovea underwent structural changes as the foveal hyporeflective zone ( HRZ ) became diminished in CNTF-treated eyes .
RESULTS	No objectively measurable enhancement of cone function was found by assessments of visual acuity , mesopic increment sensitivity threshold , or the photopic ERG .
RESULTS	Careful measurements of color hue discrimination showed no change .
RESULTS	Nonetheless , subjects reported beneficial changes of visual function in the treated eyes , including reduced light sensitivity and aversion to bright light , which may trace to decreased effective ambient light from the pupillary constriction ; further they noted slowed adaptation to darkness , consistent with CNTF action on rod photoreceptors .
CONCLUSIONS	Ciliary neurotrophic factor did not measurably enhance cone function , which reveals a species difference between human and canine CNGB3 cones in response to CNTF .
CONCLUSIONS	( ClinicalTrials.gov number , NCT01648452 . )

###24446723
OBJECTIVE	SRT2104 is a selective activator of SIRT1 .
OBJECTIVE	In animal models , SRT2104 improves glucose homeostasis and increases insulin sensitivity .
OBJECTIVE	We evaluated the tolerability and pharmacokinetics of SRT2104 , and its effects on glycaemic control , in adults with type 2 diabetes mellitus .
METHODS	Type 2 diabetics with glycosylated haemoglobin ( HbA1c ) 7.5 % and 10.5 % , fasting glucose 160 and 240mgdl ( -1 ) , and on stable doses of metformin were evenly randomized to placebo or SRT2104 0.25 g , 0.5 g , 1.0 g or 2.0 g , administered orally once daily for 28days .
METHODS	Changes in fasting and post-prandial glucose and insulin were analyzed .
RESULTS	Safety evaluation found no major differences between groups in the frequency of adverse events .
RESULTS	SRT2104 concentrations did not increase in a dose-proportional fashion .
RESULTS	Significant variability in exposure was observed .
RESULTS	Treatment with SRT2104 did not lead to any consistent , dose-related changes in glucose or insulin .
RESULTS	Day 28 change from baseline ( mean ( SD ) ) : fasting glucose ( mmoll ( -1 ) ) = -1.17 ( 2.42 ) , -1.11 ( 3.45 ) , -0.52 ( 2.60 ) , -0.97 ( 2.83 ) and -0.15 ( 2.38 ) for placebo , 0.25 g , 0.5 g , 1.0 g and 2.0 g , respectively .
RESULTS	Day 28 change from baseline ( mean ( SD ) ) : fasting insulin ( mmoll ( -1 ) ) = 1.0 ( 51.66 ) , 8.9 ( 95.04 ) , -6.9 ( 41.45 ) , 4.1 ( 57.16 ) and 15.2 ( 138.79 ) for placebo , 0.25 g , 0.5 g , 1.0 g and 2.0 g , respectively ) Treatment with SRT2104 was associated with improvement in lipid profiles .
CONCLUSIONS	Treatment with SRT2104 for 28days did not result in improved glucose or insulin control which is likely due to the observed pharmacokinetics which were not dose proportional and had large between subject variability .

###25231836
BACKGROUND	We examined the degree of postprandial triglyceride ( TG ) response over the day , representing a highly dynamic state , with continuous metabolic adaptations , among normal-weight , overweight and obese patients , according to their metabolically healthy or abnormal status .
METHODS	A total of 1002 patients from the CORDIOPREV clinical trial ( NCT00924937 ) were submitted to an oral fat load test meal with 07 g fat/kg body weight ( 12 % saturated fatty acids ( SFA ) , 10 % polyunsaturated fatty acids ( PUFA ) , 43 % monounsaturated fatty acids ( MUFA ) , 10 % protein and 25 % carbohydrates ) .
METHODS	Serial blood test analysing lipid fractions and inflammation markers ( high-sensitivity C-reactive protein ( hs-CRP ) ) were drawn at 0 , 1 , 2 , 3 and 4 h during postprandial state .
METHODS	We explored the dynamic response according to six body size phenotypes : ( i ) normal weight , metabolically healthy ; ( ii ) normal weight , metabolically abnormal ; ( iii ) overweight , metabolically healthy ; ( iv ) overweight , metabolically abnormal ; ( v ) obese , metabolically healthy ; and ( vi ) obese , metabolically abnormal .
RESULTS	Metabolically healthy patients displayed lower postprandial response of plasma TG and large triacylglycerol-rich lipoproteins ( TRLs ) - TG , compared with those metabolically abnormal , independently whether or not they were obese ( P < 0001 and P < 0001 , respectively ) .
RESULTS	Moreover , the area under the curve ( AUC ) of TG and AUC of large TRLs-TG were greater in the group of metabolically abnormal compared with the group of metabolically healthy ( P < 0001 and P < 0001 , respectively ) .
RESULTS	Interestingly , metabolically abnormal subjects displayed higher postprandial response of plasma hs-CRP than did the subgroup of normal , overweight and obese , metabolically healthy patients ( P < 0001 ) .
CONCLUSIONS	Our findings showed that certain types of the metabolic phenotypes of obesity are more favourable modulating phenotypic flexibility after a dynamic fat load test , through TG metabolism and inflammation homoeostasis .
CONCLUSIONS	To identify , these phenotypes may be the best strategy for personalized treatment of obesity .

###25038431
OBJECTIVE	No therapy has been proven to prevent the recurrence of diverticulitis .
OBJECTIVE	Mesalamine has shown efficacy in preventing relapse in inflammatory bowel disease , and there is preliminary evidence that it might be effective for diverticular disease .
OBJECTIVE	We investigated the efficacy of mesalamine in preventing recurrence of diverticulitis in 2 identical but separate phase 3 , randomized , double-blind , placebo-controlled , multicenter trials ( identical confirmatory trials were conducted for regulatory reasons ) .
METHODS	We evaluated the efficacy and safety of multimatrix mesalamine vs placebo in the prevention of recurrent diverticulitis in 590 ( PREVENT1 ) and 592 ( PREVENT2 ) adult patients with 1 episodes of acute diverticulitis in the previous 24 months that resolved without surgery .
METHODS	Patients received mesalamine ( 1.2 g , 2.4 g , or 4.8 g ) or placebo once daily for 104 weeks .
METHODS	The primary end point was the proportion of recurrence-free patients at week 104 .
METHODS	Diverticulitis recurrence was defined as surgical intervention at any time for diverticular disease or presence of computed tomography scan results demonstrating bowel wall thickening ( > 5 mm ) and/or fat stranding consistent with diverticulitis .
METHODS	For a portion of the study , recurrence also required the presence of abdominal pain and an increase in white blood cells .
RESULTS	Mesalamine did not reduce the rate of diverticulitis recurrence at week 104 .
RESULTS	Among patients in PREVENT1 , 53 % -63 % did not have disease recurrence , compared with 65 % of those given placebo .
RESULTS	Among patients in PREVENT2 , 59 % -69 % of patients did not have disease recurrence , compared with 68 % of those given placebo .
RESULTS	Mesalamine did not reduce time to recurrence , and the proportions of patients requiring surgery were comparable among treatment groups .
RESULTS	No new adverse events were identified with mesalamine administration .
CONCLUSIONS	Mesalamine was not superior to placebo in preventing recurrent diverticulitis .
CONCLUSIONS	Mesalamine is not recommended for this indication .
CONCLUSIONS	ClinicalTrials.gov ID : NCT00545740 and NCT00545103 .

###24723314
OBJECTIVE	Prior work aimed at improving our understanding of human cerebral autoregulation has explored individual physiological mechanisms of autoregulation in isolation , but none has attempted to consolidate the individual roles of these mechanisms into a comprehensive model of the overall cerebral pressure-flow relationship .
METHODS	We retrospectively analyzed this relationship before and after pharmacological blockade of - adrenergic - , muscarinic - , and calcium channel-mediated mechanisms in 43 healthy volunteers to determine the relative contributions of the sympathetic , cholinergic , and myogenic controllers to cerebral autoregulation .
METHODS	Projection pursuit regression was used to assess the effect of pharmacological blockade on the cerebral pressure-flow relationship .
METHODS	Subsequently , ANCOVA decomposition was used to determine the cumulative effect of these 3 mechanisms on cerebral autoregulation and whether they can fully explain it .
RESULTS	Sympathetic , cholinergic , and myogenic mechanisms together accounted for 62 % of the cerebral pressure-flow relationship ( P < 0.05 ) , with significant and distinct contributions from each of the 3 effectors .
RESULTS	ANCOVA decomposition demonstrated that myogenic effectors were the largest determinant of the cerebral pressure-flow relationship , but their effect was outside of the autoregulatory region where neurogenic control appeared prepotent .
CONCLUSIONS	Our results suggest that myogenic effects occur outside the active region of autoregulation , whereas neurogenic influences are largely responsible for cerebral blood flow control within it .
CONCLUSIONS	However , our model of cerebral autoregulation left 38 % of the cerebral pressure-flow relationship unexplained , suggesting that there are other physiological mechanisms that contribute to cerebral autoregulation .

###25703777
OBJECTIVE	This study examined relationships between activities of daily living ( ADL ) motor and process skills , unimanual capacity , bimanual performance , and visual perception in children with unilateral cerebral palsy ( CP ) .
METHODS	Participants were 101 children with unilateral CP ( 51 males , 50 females ; mean age 11y 9mo [ SD 2y 5mo ; range 8-17y ] ; Manual Ability Classification System [ MACS ] level I = 24 ; level II = 76 ; level III = 1 ) .
METHODS	Measures were ( 1 ) Assessment of Motor and Process Skills ( AMPS ) , ( 2 ) Jebsen-Taylor Test of Hand Function ( JTTHF ) , ( 3 ) Assisting Hand Assessment ( AHA ) , and ( 4 ) Test of Visual Perceptual Skills , 3rd edition ( TVPS-3 ) .
METHODS	Regression models were constructed with the AMPS motor scale and AMPS process as the dependent variables .
RESULTS	The AHA and JTTHF dominant upper limb score together explained 57 % of the variance in AMPS motor scale scores .
RESULTS	TVPS-3 Visual Sequential Memory , TVPS-3 Visual Closure , and JTTHF dominant upper limb score together explained 35 % of the variance in AMPS process scale scores .
CONCLUSIONS	Bimanual performance and unimanual capacity of the dominant upper limb are significantly associated with ADL motor skills in children with unilateral CP .
CONCLUSIONS	Process skills of ADL are related to visual perceptual ability and dominant upper limb unimanual capacity , which may reflect motor planning required to perform daily tasks .

###26164096
BACKGROUND	Before this study started , the standard postoperative chemotherapy regimen for stage II-III Wilms ' tumour pretreated with chemotherapy was to include doxorubicin .
BACKGROUND	However , avoidance of doxorubicin-related cardiotoxicity effects is important to improve long-term outcomes for childhood cancers that have excellent prognosis .
BACKGROUND	We aimed to assess whether doxorubicin can be omitted safely from chemotherapy for stage II-III , histological intermediate-risk Wilms ' tumour when a newly defined high-risk blastemal subtype was excluded from randomisation .
METHODS	For this international , multicentre , open-label , non-inferiority , phase 3 , randomised SIOP WT 2001 trial , we recruited children aged 6 months to 18 years at the time of diagnosis of a primary renal tumour from 251 hospitals in 26 countries who had received 4 weeks of preoperative chemotherapy with vincristine and actinomycin D. Children with stage II-III intermediate-risk Wilms ' tumours assessed after delayed nephrectomy were randomly assigned ( 1:1 ) by a minimisation technique to receive vincristine 15 mg/m ( 2 ) at weeks 1-8 , 11 , 12 , 14 , 15 , 17 , 18 , 20 , 21 , 23 , 24 , 26 , and 27 , plus actinomycin D 45 g/kg every 3 weeks from week 2 , either with five doses of doxorubicin 50 mg/m ( 2 ) given every 6 weeks from week 2 ( standard treatment ) or without doxorubicin ( experimental treatment ) .
METHODS	The primary endpoint was non-inferiority of event-free survival at 2 years , analysed by intention to treat and a margin of 10 % .
METHODS	Assessment of safety and adverse events included systematic monitoring of hepatic toxicity and cardiotoxicity .
METHODS	This trial is registered with EudraCT , number 2007-004591-39 , and is closed to new participants .
RESULTS	Between Nov 1 , 2001 , and Dec 16 , 2009 , we recruited 583 patients , 341 with stage II and 242 with stage III tumours , and randomly assigned 291 children to treatment including doxorubicin , and 292 children to treatment excluding doxorubicin .
RESULTS	Median follow-up was 608 months ( IQR 408-798 ) .
RESULTS	2 year event-free survival was 926 % ( 95 % CI 896-957 ) for treatment including doxorubicin and 882 % ( 845-921 ) for treatment excluding doxorubicin , a difference of 44 % ( 95 % CI 04-93 ) that did not exceed the predefined 10 % margin .
RESULTS	5 year overall survival was 965 % ( 943-988 ) for treatment including doxorubicin and 958 % ( 933-984 ) for treatment excluding doxorubicin .
RESULTS	Four children died from a treatment-related toxic effect ; one ( < 1 % ) of 291 receiving treatment including doxorubicin died of sepsis , three ( 1 % ) of 292 receiving treatment excluding doxorubicin died of varicella , metabolic seizure , and sepsis during treatment for relapse .
RESULTS	17 patients ( 3 % ) had hepatic veno-occlusive disease .
RESULTS	Cardiotoxic effects were reported in 15 ( 5 % ) of 291 children receiving treatment including doxorubicin .
RESULTS	12 children receiving treatment including doxorubicin , and ten children receiving treatment excluding doxorubicin , died , with the remaining deaths from tumour recurrence .
CONCLUSIONS	Doxorubicin does not need to be included in treatment of stage II-III intermediate risk Wilms ' tumour when the histological response to preoperative chemotherapy is incorporated into the risk stratification .
BACKGROUND	See Acknowledgments for funders .

###24229770
OBJECTIVE	The aim of this study was to compare the effect of pioglitazone with glimepiride on coronary arterial inflammation with serial ( 18 ) F-fluorodeoxyglucose ( FDG ) - positron emission tomography ( PET ) combined with computed tomography ( CT ) angiography .
BACKGROUND	Recent studies have shown that FDG-PET combined with CT is a reliable tool to visualize and quantify vascular inflammation .
BACKGROUND	Although pioglitazone significantly prevented the progression of coronary atherosclerosis and reduced the recurrence of myocardial infarction in patients with type 2 diabetes mellitus ( DM ) , it remains unclear whether pioglitazone could attenuate coronary artery inflammation .
METHODS	Fifty atherosclerotic patients with impaired glucose tolerance or type 2 DM underwent determination of blood chemistries , anthropometric and inflammatory variables , and FDG-PET/CT angiography , and then were randomized to receive either pioglitazone or glimepiride for 16 weeks .
METHODS	Effects of the treatments on vascular inflammation of the left main trunk were evaluated by FDG-PET/CT angiography at baseline and end of the study .
METHODS	Vascular inflammation of the left main trunk was measured by blood-normalized standardized uptake value , known as a target-to-background ratio .
RESULTS	Three patients dropped out of the study during the assessment or treatment .
RESULTS	Finally , 25 pioglitazone-treated patients and 22 glimepiride-treated patients ( 37 men ; mean age : 68.1 8.3 years ; glycosylated hemoglobin : 6.72 0.70 % ) completed the study .
RESULTS	After 16-week treatments , fasting plasma glucose and glycosylated hemoglobin values were comparably reduced in both groups .
RESULTS	Changes in target-to-background ratio values from baseline were significantly greater in the pioglitazone group than in the glimepiride group ( -0.12 0.06 vs. 0.09 0.07 , p = 0.032 ) , as well as changes in high-sensitivity C-reactive protein ( pioglitazone vs. glimepiride group : median : -0.24 [ interquartile range ( IQR ) : -1.58 to -0.04 ] mg/l vs. 0.08 [ IQR : -0.07 to 0.79 ] mg/l , p = 0.031 ) .
CONCLUSIONS	Our study indicated that pioglitazone attenuated left main trunk inflammation in patients with impaired glucose tolerance or DM in a glucose-lowering independent manner , suggesting that pioglitazone may protect against cardiac events in patients with impaired glucose tolerance or DM by suppressing coronary inflammation .
CONCLUSIONS	( Anti-Inflammatory Effects of Pioglitazone ; NCT00722631 ) .

###24461277
BACKGROUND	Postoperative nausea and vomiting ( PONV ) is a major concern for patients having surgery under general anesthesia as it causes subjective distress along with increased complications and delays in discharge from the hospital .
BACKGROUND	Aromatherapy represents a complementary and alternative therapy for the management of PONV .
OBJECTIVE	The objective of this study was to compare the effectiveness of aromatherapy ( QueaseEase , Soothing Scents , Inc , Enterprise , AL ) versus an unscented inhalant in relieving PONV .
METHODS	One hundred twenty-one patients with postoperative nausea were randomized into a treatment group receiving an aromatic inhaler and a control group receiving a placebo inhaler to evaluate the effectiveness of aromatherapy .
RESULTS	Initial and follow-up nausea assessment scores in both treatment and placebo groups decreased significantly ( P < .01 ) , and there was a significant difference between the two groups ( P = .03 ) .
RESULTS	Perceived effectiveness of aromatherapy was significantly higher in the treatment group ( P < .001 ) .
CONCLUSIONS	Aromatherapy was favorably received by most patients and represents an effective treatment option for postoperative nausea .

###24529582
OBJECTIVE	To investigate the effects of sertraline on semen parameters and comparison of its effect with behavioral therapy ( BT ) in men with primary premature ejaculation .
METHODS	In this single-blinded clinical trial , a total of 60 married men with primary premature ejaculation were randomly divided into 2 groups : the sertraline group ( n = 30 , sertraline 25 mg/day for 1 week followed by 50 mg/day for 3 months ) and the BT group ( n = 30 , using BT technique for 3 months ) .
METHODS	Semen analysis was applied , and the results were compared between groups before and 3 months after intervention .
RESULTS	The significant reduction in sperm concentration ( 10 ( 5 ) / mL ) and percentage of normal morphology was reported in sertraline group ( P < .05 ) .
RESULTS	The percentage of sperm deoxyribonucleic acid fragmentation after intervention in sertraline group was significantly higher than BT group ( P = .004 ) .
RESULTS	There was no significant change in semen parameters in patients treated using BT .
CONCLUSIONS	Our study revealed detrimental effects of sertraline on some semen parameters .
CONCLUSIONS	It should particularly be considered in patients who are trying to conceive .
CONCLUSIONS	It seems BT is a safe method without any side effect on semen analysis parameters .

###24280464
OBJECTIVE	This study was performed to evaluate the effectiveness of Benson 's relaxation technique in the quality of sleep of hemodialysis patients .
METHODS	It was a randomized controlled trial with a pre-post-test design .
METHODS	A total of 86 hemodialysis patients referring to hemodialysis units were assigned to either the intervention ( receiving Benson 's relaxation technique ) or the control group ( routine care ) through block randomization .
METHODS	The study was performed in two hemodialysis units affiliated to Shiraz University of Medical Sciences , Shiraz , Iran .
METHODS	The patients in the intervention group listened to the audiotape of Benson 's relaxation technique twice a day each time for twenty minutes for eight weeks .
METHODS	The global score of Pittsburgh Sleep Quality Index ( PSQI ) as well as its components was computed in both the intervention and the control group before and at the 8th week of the intervention .
RESULTS	The results of ANCOVA indicated significant differences between the two groups regarding the scores of Pittsburgh Sleep Quality Index subscales , such as sleep disturbance , daytime dysfunction , the use of sleep medication , and subjective sleep quality and as well as its global scores at the 8th week of the intervention ( p < 0.05 ) .
CONCLUSIONS	This study highlighted the importance of Benson 's relaxation technique in improvement of the sleep quality of the patients on hemodialysis .
CONCLUSIONS	Thus , educational sessions are recommended to be planned on this cost effective and easy to use relaxation technique in order to improve hemodialysis patients ' sleep quality .
CONCLUSIONS	Further studies are needed to assess the effectiveness of this technique in other groups of patients .

###24622227
OBJECTIVE	The objective of the present study was to evaluate the long-term effectiveness of an exercise program in modifying the exercise behavior of the community-dwelling elderly subjects .
METHODS	This study was a single-blinded randomized controlled trial .
METHODS	The subjects included 52 males and 65 females 65 years of age or over who were randomly assigned to an exercise-intervention group or a health-education group .
METHODS	The stages of change in exercise behavior were evaluated before and one-year after the intervention period .
METHODS	The subjects ' physical function ( muscle strength , balance , walking speed ) and self-efficacy in each domain of the physical function were measured during the intervention period .
RESULTS	There were no significant differences in the stages of change before the intervention between the two groups .
RESULTS	Significant differences in the stages of change were observed in `` relapse '' of stages at two points in time between the two groups ( p < .01 ) .
RESULTS	A logistic regression analysis showed that `` progression '' of stages was associated with improvements in the timed up and go test ( AOR 2.7 ; 95 % CI 1.3-5 .8 ) and sit and reach ( AOR 1.14 ; 95 % CI 1.0-1 .3 ) , while `` relapse '' of stages was associated with the group allocation ( AOR 4.6 ; 95 % CI 1.1-18 .8 ) , self-efficacy in `` Walking '' ( AOR 1.54 ; 95 % CI 1.0-2 .3 ) and `` Stair climbing '' ( AOR 0.68 ; 95 % CI 0.5-0 .9 ) with respect to physical activity during the intervention period .
CONCLUSIONS	The results suggest that exercise intervention in community-dwelling elderly subjects is effective in preventing `` relapse '' of exercise behavior over long periods .

###24398786
OBJECTIVE	Freeze-dried powdered yacon ( FDY ) can be considered a prebiotic product due to its fructooligosaccharides ( FOS ) content .
OBJECTIVE	The effect of 9weeks of daily intake of FDY containing 7.4 g of FOS on glucose , lipid metabolism and intestinal transit in a group of elderly people was investigated .
METHODS	Seventy-two elderly ( mean age 67.116.11 ) men and women were studied for 9weeks in a double-blind , placebo-controlled experiment .
METHODS	They were randomly assigned to the supplement group ( which received 7.4 g of FOS as FDY ) or the control group .
METHODS	At the beginning and end of the study , anthropometric measurements , blood sampling , clinical analyses and dietary intake were assessed .
RESULTS	A daily intake of FDY containing 7.4 g of FOS for 9weeks was associated with a mean decrease in serum glucose ( p = 0.013 ) , but supplementation did not reduce serum lipids in the study group .
RESULTS	The administered dose did not adversely affect intestinal transit .
RESULTS	It did not cause bloating , flatulence or intestinal discomfort .
CONCLUSIONS	Freeze-dried powdered yacon is a good source of FOS , and daily consumption can have a favourable effect on serum glucose in the elderly .
CONCLUSIONS	It is also practical , easy and safe to use and store .

###24433430
BACKGROUND	UK guidelines recommend that all early active rheumatoid arthritis ( RA ) patients are offered combination disease-modifying antirheumatic drugs ( DMARDs ) and short-term corticosteroids .
BACKGROUND	Anti-citrullinated protein antibody ( ACPA ) - positive and ACPA-negative RA may differ in their treatment responses .
BACKGROUND	We used data from a randomized controlled trial - the Combination Anti-Rheumatic Drugs in Early RA ( CARDERA ) trial - to examine whether responses to intensive combination treatments in early RA differ by ACPA status .
METHODS	The CARDERA trial randomized 467 early active RA patients to receive : ( 1 ) methotrexate , ( 2 ) methotrexate/ciclosporin , ( 3 ) methotrexate/prednisolone or ( 4 ) methotrexate/ciclosporin/prednisolone in a factorial-design .
METHODS	Patients were assessed every six months for two years .
METHODS	In this analysis we evaluated 431 patients with available ACPA status .
METHODS	To minimize multiple testing we used a mixed-effects repeated measures ANOVA model to test for an interaction between ACPA and treatment on mean changes from baseline for each outcome ( Larsen , disease activity scores on a 28-joint count ( DAS28 ) , Health Assessment Questionnaire ( HAQ ) , EuroQol , SF-36 physical component summary ( PCS ) and mental component summary ( MCS ) scores ) .
METHODS	When a significant interaction was present , mean changes in outcomes were compared by treatment group at each time point using t-tests stratified by ACPA status .
METHODS	Odds ratios ( ORs ) for the onset of new erosions with treatment were calculated stratified by ACPA .
RESULTS	ACPA status influenced the need for combination treatments to reduce radiological progression .
RESULTS	ACPA-positive patients had significant reductions in Larsen score progression with all treatments .
RESULTS	ACPA-positive patients receiving triple therapy had the greatest benefits : two-year mean Larsen score increases comprised 3.66 ( 95 % confidence interval ( CI ) 2.27 to 5.05 ) with triple therapy and 9.58 ( 95 % CI 6.76 to 12.39 ) with monotherapy ; OR for new erosions with triple therapy versus monotherapy was 0.32 ( 95 % CI 0.14 to 0.72 ; P = 0.003 ) .
RESULTS	ACPA-negative patients had minimal radiological progression irrespective of treatment .
RESULTS	Corticosteroid 's impact on improving DAS28/PCS scores was confined to ACPA-positive RA .
CONCLUSIONS	ACPA status influences the need for combination DMARDs and high-dose tapering corticosteroids in early RA .
CONCLUSIONS	In CARDERA , combination therapy was only required to prevent radiological progression in ACPA-positive patients ; corticosteroids only provided significant disease activity and physical health improvements in ACPA-positive disease .
CONCLUSIONS	This suggests ACPA is an important biomarker for guiding treatment decisions in early RA .
BACKGROUND	Current Controlled Trials ISRCTN32484878 .

###26025097
OBJECTIVE	To assess change in intraocular pressure ( IOP ) in patients with neovascular age-related macular degeneration ( NVAMD ) receiving intravitreal aflibercept injection ( IAI ) or ranibizumab in VEGF Trap-Eye : Investigation of Efficacy and Safety in Wet AMD ( VIEW ) 1 and 2 studies .
METHODS	Analyses from 2 randomized , active-controlled , phase III trials .
METHODS	A total of 2457 patients with NVAMD .
METHODS	Patients received IAI 2 mg every ( q ) 4 weeks ( 2q4 ) , 0.5 mg q4 weeks ( 0.5 q4 ) , 2 mg q8 weeks ( after 3 monthly doses ; 2q8 ) , or ranibizumab 0.5 mg q4 weeks ( Rq4 ) for 52 weeks .
METHODS	At week 52 , patients were switched to a variable regimen requiring at least quarterly dosing and allowing interim injections based on anatomic and visual assessment .
METHODS	Pre-injection IOP was analyzed in study and uninjected fellow eyes from baseline to week 96 .
METHODS	Prespecified end points included mean change in IOP from baseline and prevalence of a > 21 mmHg and > 10 mmHg increase in IOP from baseline .
METHODS	Cumulative incidence of sustained ( at 2 consecutive visits ) IOP > 21 mmHg , a single event of IOP > 25 mmHg , and sustained IOP increase from baseline ( 5 mmHg ) was also evaluated .
RESULTS	Mean IOP change from baseline over 96 weeks in all IAI groups was consistently lower than in the Rq4 group , and this finding was replicated in both trials .
RESULTS	In an analysis integrating both studies , the proportion of study eyes with IOP > 21 mmHg at week 96 was 20.2 % , 14.2 % , 12.1 % , and 12.5 % in Rq4 , 2q4 , 2q8 , and 0.5 q4 , respectively .
RESULTS	Reduction in risk , relative to Rq4 , of having sustained IOP > 21 mmHg over 96 weeks was 62 % ( 95 % confidence interval [ CI ] , 36 % -78 % ) , 50 % ( 95 % CI , 19 % -70 % ) , and 69 % ( 95 % CI , 45 % -84 % ) for 2q4 , 2q8 , and 0.5 q4 , respectively .
RESULTS	Risk reduction in the IAI groups for a sustained IOP increase 5 mmHg was 31 % ( 95 % CI , 8 % -48 % ) , 38 % ( 95 % CI , 17 % -54 % ) , and 47 % ( 95 % CI , 27 % -61 % ) , respectively .
RESULTS	In uninjected fellow eyes , only sustained IOP > 21 mmHg events were higher in the Rq4 group compared with all IAI groups .
CONCLUSIONS	Incidence of elevated IOP in eyes with NVAMD was lower in all IAI groups than in the ranibizumab group .

###25605189
BACKGROUND	The study aimed to investigate the analgesic effect of a combination of intravenous flurbiprofen axetil and opioids , and evaluate the relationship between refractory pain relief and plasma - endorphin levels in cancer patients .
METHODS	A total of 120 cancer patients was randomly divided into two groups , 60 patients took orally morphine sulfate sustained-release tablets in group A , and another 60 patients receiving the combination treatment of intravenous flurbiprofen axetil and opioid drugs in group B.
METHODS	After 7 days , pain relief , quality of life improvement and side effects were evaluated .
METHODS	Furthermore , plasma - endorphin levels were measured by radioimmunoassay .
RESULTS	With the combination treatment of intravenous intravenous flurbiprofen axetil and opioids , the total effective rate of pain relief rose to 91.4 % , as compared to 82.1 % when morphine sulfate sustained-release tablet was used alone .
RESULTS	Compared with that of group A , the analgesic effect increased in group B ( p = 0.031 ) .
RESULTS	Moreover , satisfactory pain relief was associated with a significant increase in plasma - endorphin levels .
RESULTS	After the treatment , plasma - endorphin level in group B was 62.413.5 pg/ml , which was higher than that in group A ( 45.811.2 pg/ml ) ( p < 0.05 ) .
CONCLUSIONS	Our results suggest the combination of intravenous flurbiprofen axetil and opioids can enhance the analgesic effect of opioid drugs by increasing plasma - endorphin levels , which would offer a selected and reliable strategy for refractory cancer pain treatment .

###24528195
OBJECTIVE	This study evaluated the impact of an Internet-based telematic system on the economic and clinical management of patients with type 1 diabetes mellitus .
METHODS	This 6-month prospective , randomized , comparative , open , multicenter study included patients with type 1 diabetes > 18 years old treated with multiple insulin doses and with a glycated hemoglobin ( HbA1c ) level of > 8 % .
METHODS	We compared an intervention group ( IG ) ( two face-to-face and five telematic appointments ) with a control group ( CG ) ( seven face-to-face appointments ) .
METHODS	The variables studied were ( 1 ) patient and healthcare team costs , ( 2 ) metabolic control , ( 3 ) knowledge of diabetes , ( 4 ) quality of life , and ( 5 ) self-care treatment adherence .
RESULTS	Of the 154 patients included , 118 ( 76.6 % ) completed the study ( IG , 54 ; CG , 64 ) .
RESULTS	The time used by the CG to follow the program was 823645 min versus 353222 min in the IG ( P < 0.0001 ) .
RESULTS	Compared with the CG , the IG required less healthcare time from the professionals ( 288105 min vs. 23289 min ; P < 0.001 ) .
RESULTS	HbA1c improved in both groups ( IG , 9.21.5 % [ 77.017.0 mmol/mol ] vs. 8.71.5 % [ 71.617.0 mmol/mol ] [ P < 0.001 ] ; CG , 9.20.9 % [ 77.010.0 mmol/mol ] vs. 8.60.9 % [ 70.510.0 mmol/mol ] [ P < 0.001 ] , as did knowledge and self-care treatment adherence .
CONCLUSIONS	The use of interactive telematic appointments in subjects with type 1 diabetes and inadequate metabolic control is an efficient strategy , providing results comparable to those of face-to-face appointments in relation to improvement in glycemic control , knowledge acquisition , and self-care treatment adherence , with a significant reduction in the time used , especially by patients .

###25220709
OBJECTIVE	The safety and tolerability of a new low-dose levonorgestrel/ethinyl estradiol ( LNG/EE ) contraceptive patch was compared with 2 combination oral contraceptives in 2 clinical studies in which approximately 30 % of enrolled participants were obese .
METHODS	Two phase 3 , open-label , randomized , parallel-group , multicenter trials compared the LNG/EE contraceptive patch ( n = 1579 ) with combination oral contraceptives ( n = 581 ) in healthy women 17-40 years of age .
METHODS	Combination oral contraceptives were LNG 100 g per EE 20 g ( combination oral contraceptive 20 ; n = 375 ) or LNG 150 g per EE 30 g ( combination oral contraceptive 30 ; n = 206 ) .
METHODS	Safety and tolerability data from the 2 trials were evaluated in integrated safety analyses .
RESULTS	Treatment-emergent adverse events of 2 % or greater in the LNG/EE contraceptive patch were nasopharyngitis ( 5.2 % ) , nausea ( 4.1 % ) , upper respiratory infection ( 3.5 % ) , headache ( 3.4 % ) , sinusitis ( 2.9 % ) , cervical dysplasia ( 2.3 % ) , and urinary tract infection ( 2.1 % ) .
RESULTS	Including skin reaction-related treatment-emergent adverse events , the proportion of women who experienced any treatment-emergent adverse event was similar among women randomized to the contraceptive patch ( 47.5 % ) , the combination oral contraceptive 20 ( 47.4 % ) , or the combination oral contraceptive 30 ( 46.8 % ) .
RESULTS	The incidence of treatment-emergent adverse events was similar in obese vs nonobese participants in all groups .
RESULTS	Serious adverse events occurred in less than 1 % of participants in any of the treatment groups .
CONCLUSIONS	The LNG/EE contraceptive patch and combination oral contraceptives were well tolerated and associated with similar treatment-emergent adverse event incidences in obese and nonobese women .

###24442560
OBJECTIVE	Nocturia is prevalent and bothersome in men with lower urinary tract symptoms suggestive of BPH ( LUTS/BPH ) .
OBJECTIVE	- Adrenoceptor antagonists without subtype selectivity have inconsistently shown significant effects on nocturia in these patients .
OBJECTIVE	We explored the effects of the 1A-adrenoceptor subtype-selective antagonist silodosin on nocturia by analyzing three placebo-controlled registration studies .
METHODS	Responses to question 7 of the IPSS questionnaire were analyzed for the entire study population and patients with 2 voids/night at baseline .
METHODS	Improvement/worsening rates for nocturia were calculated for once-daily silodosin 8 mg and placebo .
METHODS	Silodosin effects on the mean number of nocturnal voids were compared with placebo , and the number of patients in whom nocturia was reduced to < 2 times was calculated .
RESULTS	In total , 1,479 men were treated with silodosin or placebo ; 1,266 men ( 85 % ) had 2 voids/night at baseline .
RESULTS	Compared to placebo , more men treated with silodosin reported about nocturia improvement ( 53.4 vs. 42.8 % , p < 0.0001 ) and fewer patients about worsening ( 9.0 vs. 14.3 % , p < 0.0001 ) .
RESULTS	Silodosin significantly reduced nocturia within each study and pooled cohort compared to placebo ( p < 0.001 ) .
RESULTS	In men with 2 nocturnal voids at baseline , 61 and 49 % of patients with silodosin and placebo had reductions of 1 voids/night , respectively ( p = 0.0003 ) , and significantly more patients with silodosin had < 2 nocturia episodes at study end compared to placebo ( 29.3 vs. 19.0 % ; p = 0.0002 ) .
CONCLUSIONS	Although a weak impact on nocturia is already known from - adrenoceptor antagonists without subtype selectivity , the individual placebo-controlled studies and the pooled data analysis showed that the 1A-adrenoceptor subtype-selective antagonist silodosin consistently and significantly improves nocturia in men with LUTS/BPH .

###24332934
OBJECTIVE	To investigate how COPD patients respond to motivational cues that aim to improve activity behavior and how these responses are related to cue - and context characteristics .
OBJECTIVE	In addition , to explore whether activity can be increased and better distributed over the day by providing such cues .
METHODS	Fifteen COPD patients participated .
METHODS	Patients used an activity sensor with a smartphone for four weeks , at least four days/week .
METHODS	Patients received motivational cues every 2h with advice on how to improve their activity , on top of real-time visual feedback .
METHODS	The response was calculated by the amount of activity 30 min before and after a cue .
RESULTS	In total , 1488 cues were generated .
RESULTS	The amount of activity significantly decreased in the 30 min after a discouraging cue ( p < 0.001 ) and significantly increased ( p < 0.05 ) in the 10 min after an encouraging cue .
RESULTS	The activity level increased with 13 % in the intervention period compared to corrected baseline ( p = 0.008 ) .
RESULTS	The activity was not more balanced over the day .
CONCLUSIONS	COPD patients significantly change their activity level in response to motivational cues , based on continuous ambulatory assessment of activity levels .
CONCLUSIONS	Motivational cues could be a valuable component of telemedicine interventions that aim to improve activity behavior .

###24486426
OBJECTIVE	To estimate the cost-effectiveness of a supported employment ( SE ) intervention that had been previously found effective in veterans with spinal cord injuries ( SCIs ) .
METHODS	Cost-effectiveness analysis , using cost and quality-of-life data gathered in a trial of SE for veterans with SCI .
METHODS	SCI centers in the Veterans Health Administration .
METHODS	Subjects ( N = 157 ) who completed a study of SE in 6 SCI centers .
METHODS	Subjects were randomly assigned to the intervention of SE ( n = 81 ) or treatment as usual ( n = 76 ) .
METHODS	A vocational rehabilitation program of SE for veterans with SCI .
METHODS	Costs and quality-adjusted life years , which were estimated from the Veterans Rand 36-Item Health Survey , extrapolated to Veterans Rand 6 Dimension utilities .
RESULTS	Average cost for the SE intervention was $ 1821 .
RESULTS	In 1 year of follow-up , estimated total costs , including health care utilization and travel expenses , and average quality-adjusted life years were not significantly different between groups , suggesting the Spinal Cord Injury Vocational Integration Program intervention was not cost-effective compared with usual care .
CONCLUSIONS	An intensive program of SE for veterans with SCI , which is more effective in achieving competitive employment , is not cost-effective after 1 year of follow-up .
CONCLUSIONS	Longer follow-up and a larger study sample will be necessary to determine whether SE yields benefits and is cost-effective in the long run for a population with SCI .

###24781225
OBJECTIVE	To study an effect of immunomodulatory therapy with cycloferon on some immunological parameters in patients with depression .
METHODS	It was examined 192 patients with recurrent depressive disorders .
METHODS	All patients were randomized into two groups -- main group ( 98 patients ) and comparison group ( 94 patients ) .
METHODS	Both groups received standard treatment with antidepressants and antipsychotics in ambulatory conditions .
METHODS	Patients of the main group additionally received cycloferon .
RESULTS	Before treatment , there was an increase in concentrations of circulatory immune complexes ( CIC ) , mainly due to most pathogenic average molecular ( 11S-19S ) and small molecular ( < 11S ) fractions , in both groups of the patients .
RESULTS	A direct correlation between the degree of the severity of the disease and the degree of changes in immunological parameters was noted .
CONCLUSIONS	Inclusion of cycloferon in the complex treatment had a positive effect on immunological parameters and led to the normalization of CIC levels and their fraction content .

###24697702
OBJECTIVE	To evaluate the effectiveness of the Bathing Without a Battle intervention in reducing physical and verbal aggressive behaviors for nursing home residents with dementia .
METHODS	A randomized crossover diffusion study , with one group receiving the intervention after one round of baseline observations and a delayed intervention group receiving the intervention after two rounds of baseline observations .
METHODS	Six nursing home facilities in the state of New York .
METHODS	Nursing home residents with dementia ( N = 240 ) .
METHODS	The Bathing Without a Battle educational program , designed for direct-care staff members responsible for bathing residents diagnosed with dementia and implemented through a train-the-trainer model .
METHODS	Rates of verbal and physical aggressive and agitated behaviors were measured using the Care Recipient Behavior Assessment ; secondary measures of effect included bath duration , bath modality , and antipsychotic medication use .
RESULTS	In spite of implementation obstacles ( consent delays and change in leadership at one facility ) , a significant change was observed in how residents were bathed that translated into a significant reduction in the rate of aggressive and agitated behaviors , particularly verbal , during residents ' baths .
RESULTS	The use of in-bed baths increased 17 % , and average bath duration decreased significantly ( average 1.5 minutes less ) in the postintervention period , particularly for in-bed baths .
RESULTS	Verbal behaviors declined 17.8 % ( P = .008 ) , combined verbal and physical behaviors declined 18.6 % ( P = .004 ) , and antipsychotic use declined 30 % ( P = .002 ) after the intervention .
CONCLUSIONS	The Bathing Without a Battle educational program , delivered through a train-the-trainer format , is an effective means of improving the bathing experience of residents with dementia in nursing homes .
CONCLUSIONS	This research supports broadly adopting this intervention , especially for nursing homes serving many residents with dementia .

###25124237
BACKGROUND	Human papillomavirus ( HPV ) is one of the most common sexually transmitted infections and is the cause of several different diseases in men and women .
BACKGROUND	Although little is known about HPV infection in men , they are also in the risk group of HPV infection and play an important role in transmitting the virus to women .
OBJECTIVE	To define the efficacy of the HPV vaccine through cross-immunization and its role in clearance of HPV infection , and to assess infection-associated factors in men .
METHODS	This prospective randomized clinical study enrolled 171 evaluable men with genital warts between June 2009 and October 2013 .
METHODS	After the initial treatment intervention , 91 patients were randomly assigned to receive HPV vaccine in three doses .
METHODS	Eighty patients were in the control ( unvaccinated ) group .
METHODS	One hundred-eleven men were single and 60 men were married .
METHODS	Patients who had previous treatment for pre-existing warts and medical disorders that needed chronic treatment or immunosuppression were not included in the randomization .
METHODS	Also 29 men with follow-up less than 12 months and incomplete vaccination were not included .
METHODS	The patients were assessed regarding age , condom use , marital status , number of visible genital warts , and smoking status .
METHODS	Post-treatment follow-up was monthly up to 12th month .
RESULTS	Mean age was 347.6 .
RESULTS	One hundred fifteen patients were smokers .
RESULTS	For the recurrence of warts , age , smoking , vaccination status were insignificant and marital status was significant in the univariable analysis ; only marital status preserved significance ( HR : 2.0 CI :1.29 -3.12 P = 0.002 ) in the multivariable analysis including vaccination status , marital status , and smoking .
CONCLUSIONS	Among the investigated factors vaccination status was not but marital status significantly influenced wart recurrence .
CONCLUSIONS	Married men had more recurrences in our population .
CONCLUSIONS	Larger multicenter randomized clinical trials are lacking and seriously required to investigate the therapeutic effect of current quadrivalent HPV vaccine in genital warts .

###24847745
BACKGROUND	Fatigue is a core symptom in fibromyalgia that can negatively affect a patient 's quality of life .
OBJECTIVE	The objective of this study was to analyze fatigue-related data from 3 randomized , placebo-controlled trials of milnacipran ( n = 3109 ) in fibromyalgia patients .
METHODS	Fatigue was assessed with the Multidimensional Fatigue Inventory ( MFI ) .
METHODS	Treatment effects were evaluated by changes in MFI total scores and identifying patients with improvement of 30 % or greater from baseline .
METHODS	Path analyses were conducted to evaluate direct and indirect effects of treatment on fatigue .
RESULTS	Patients had high levels of baseline fatigue ; mean MFI total score was 68.1 ( of 100 ) .
RESULTS	After 3 months of stable-dose treatment , patients receiving milnacipran 100 and/or 200 mg/d had significant improvement in MFI total and subscale scores ( P < 0.05 vs placebo ) .
RESULTS	The largest treatment effect was found in patients with equal to or greater than 20 % to 40 % fatigue improvement .
RESULTS	Significantly more patients met the threshold of 30 % or greater with milnacipran ( 100 mg/d , 17.6 % ; 200 mg/d , 15.2 % ) than with placebo ( 9.9 % ) ; odds ratios for this responder status were 1.93 and 1.63 , respectively ( P < 0.05 for both doses ) .
RESULTS	Path analyses indicated that up to 28 % of fatigue improvement may be attributed to direct milnacipran effects ( ie , not indirectly through effects on pain or other symptoms ) .
CONCLUSIONS	Fibromyalgia patients in the milnacipran studies had high levels of baseline fatigue .
CONCLUSIONS	Patients receiving milnacipran had statistically significant and clinically meaningful reductions in fatigue that were not completely attributable to indirect treatment effects through pain reduction .
CONCLUSIONS	Evaluating and managing fatigue are an important clinical concern when treating patients with fibromyalgia .

###24397308
OBJECTIVE	To evaluate women 's preferences for timing of elective cesarean section ( ECS ) scheduled prior to versus after 39 completed weeks .
METHODS	Secondary analyses from a randomized controlled open-label trial were conducted at seven Danish tertiary hospitals from March 2009 to June 2011 with inclusion of singleton pregnant women with a healthy fetus .
METHODS	The women were allocated by a computerized telephone system to ECS scheduled at 38 ( +3 ) weeks or 39 ( +3 ) weeks of gestation .
METHODS	Dissatisfaction with timing of ECS and preferred timing of the procedure in a proposed future ECS delivery were evaluated .
METHODS	Data analyses were done by intention-to-treat , using logistic regression .
RESULTS	A total of 1196 women ( 94 % ) completed an online questionnaire at follow-up eight weeks postpartum .
RESULTS	In the 38 weeks group , 61 ( 10 % ) women 601 were dissatisfied with the timing of their ECS , whereas in the 39 weeks group 157 ( 26 % ) of 595 were dissatisfied ( adjOR 3.18 , 95 % CI 2.30 ; 4.40 ) .
RESULTS	The proportion of women who preferred the same timing in a future ECS were 272 ( 45 % ) in the 38 weeks group compared to 232 ( 39 % ) in the 39 ( +3 ) weeks group ( adjOR 0.75 , 95 % CI 0.60 ; 0.95 ) .
CONCLUSIONS	The women in this trial preferred ECS scheduled prior to 39 weeks of gestation .

###24988438
BACKGROUND	The pharmacokinetics of raltegravir ( RAL ) in HIV patients is characterized by high interindividual and intraindividual variability .
BACKGROUND	We documented previously that HIV patients taking RAL at 400 mg bid by chewing the tablets had significantly higher drug absorption and reduced pharmacokinetic variability than patients taking the drug by swallowing the tablets .
BACKGROUND	This study extends our previous findings .
METHODS	An open-label , 2-period crossover study compared the pharmacokinetics of 2 doses of RAL given at 400 mg every 12 hours ( that mimics a bid administration ) by swallowing with 1 dose of 800 mg ( that mimics a qd administration ) by chewing the tablets in 12 healthy volunteers .
METHODS	RAL plasma concentrations were measured by a chromatographic method coupled with mass spectrometry .
RESULTS	Subjects taking RAL by chewing had significantly higher drug exposure ( RAL area under the curve [ AUC ] ( 0-24 ) : 40722 14843 versus 21753 12229 ng h/mL , P < 0.0001 ) and reduced pharmacokinetic variability compared with those taking the drug by swallowing the whole tablet , with no difference in the minimum RAL concentrations ( RAL C ( min ) : 36 23 versus 43 23 ng/mL , P = 0.298 ) .
RESULTS	Subjects taking RAL by chewing the tablets had significantly higher drug absorption and reduced pharmacokinetic variability compared with those taking the drug by swallowing .
RESULTS	No differences were observed in the minimum RAL concentrations .
CONCLUSIONS	RAL at 800 mg once daily by chewing the tablets may represent a novel therapeutic option for the treatment of HIV being associated with higher drug absorption , reduced pharmacokinetic variability , and potentially better compliance compared with patients swallowing the 400-mg bid intact tablets .

###25708026
BACKGROUND	Piriformis fossa entry antegrade femoral nailing is a common method for stabilizing diaphyseal femur fractures .
BACKGROUND	However , clinically significant complications such as chronic hip pain , hip abductor weakness , heterotopic ossification and femoral head osteonecrosis have been reported .
BACKGROUND	A recent cadaveric study found that piriformis entry nailing damaged either the deep branch of the medial femoral circumflex artery ( MFCA ) or its distal superior retinacular artery branches in 100 % of specimens and therefore recommended against its use .
BACKGROUND	However , no study has quantitatively assessed the effect of different femoral entry points on femoral head perfusion .
METHODS	Twelve fresh-frozen cadaveric lower extremity specimens were randomly allocated to either piriformis fossa or trochanteric entry nailing using a 13-mm reamer .
METHODS	The contralateral hip served as an internal matched control .
METHODS	All specimens subsequently underwent gadolinium-enhanced fat-suppressed gradient-echo sequence MRI to assess femoral head perfusion .
METHODS	Gross dissection was also performed to assess MFCA integrity and distance to the opening reamer path .
RESULTS	MRI quantification analysis revealed near full femoral head perfusion with no significant difference between the piriformis and trochanteric starting points ( 95 vs. 97 % , p = 0.94 ) .
RESULTS	There was no observed damage to the deep MFCA in either group .
RESULTS	The mean distance from the reamer path to the deep MFCA was 3.2 mm in the piriformis group compared to 18.5 mm in the trochanteric group ( p = 0.001 ) .
RESULTS	Additionally , there was a significantly greater number of mean terminal superior retinacular vessels damaged by the opening reamer in the piriformis cohort ( 1 vs. 0 ; p = 0.007 ) .
CONCLUSIONS	No statistically significant difference in femoral head perfusion was found between the two groups .
CONCLUSIONS	Therefore , we can not recommend against the use of piriformis entry femoral nails .
CONCLUSIONS	However , we caution against multiple errant starting point attempts and recommend meticulous soft tissue protection during the procedure .

###25673443
BACKGROUND	Few clinical trials have evaluated the efficacy and safety of Tripterygium wilfordii Hook F ( TwHF ) compared with acitretin in psoriasis .
BACKGROUND	We aimed to compare the efficacy and safety of TwHF compared with acitretin in the treatment of moderate to severe psoriasis vulgaris .
METHODS	Adults with Psoriasis Area Severity Index ( PASI ) score 10 and psoriasis-affected body surface area 10 % were randomized into a TwHF ( 20 mg , 3 times a day ) or acitretin group ( 30 mg , once a day ) .
METHODS	The treatment course lasted for 8 weeks .
METHODS	Patients were assessed at baseline and at 2 , 4 , and 8 weeks .
METHODS	Laboratory tests were performed at baseline , week 4 , and week 8 .
METHODS	The data were analyzed using paired samples t-test or analysis of variance ( ANOVA ) .
RESULTS	A total of 115 patients was enrolled ( 58 TwHF ; 57 acitretin ) .
RESULTS	The median PASI score improved in the TwHF group by 50.4 % and in the acitretin group by 42.7 % .
RESULTS	There was no significant difference in median PASI improvement between two groups at 2 , 4 , and 8 weeks .
RESULTS	There was also no significant difference in PASI 25 , PASI 50 , PASI 75 , and PASI 90 response between the two groups at 2 , 4 , and 8 weeks .
RESULTS	There was a significant increase in the level of aspartate transaminase and triglycerides in the TwHF group ( P = 0.026 and P = 0.011 , respectively ) .
RESULTS	In the acitretin group , there was a significant increase in the level of alanine transaminase , cholesterol , and high-density lipoprotein ( P = 0.030 , P < 0.01 , and P < 0.01 , respectively ) .
CONCLUSIONS	There was no significant difference in treatment efficacy between the TwHF and acitretin groups within 8 weeks , but there were fewer treatment-related adverse events in the TwHF group .

###25620016
BACKGROUND	Hypertension contributes to cardiovascular morbidity and mortality .
BACKGROUND	We assessed the safety and efficacy of a central iliac arteriovenous anastomosis to alter the mechanical arterial properties and reduce blood pressure in patients with uncontrolled hypertension .
METHODS	We enrolled patients in this open-label , multicentre , prospective , randomised , controlled trial between October , 2012 , and April , 2014 .
METHODS	Eligible patients had baseline office systolic blood pressure of 140 mm Hg or higher and average daytime ambulatory blood pressure of 135 mm Hg or higher systolic and 85 mm Hg or higher diastolic despite antihypertensive treatment .
METHODS	Patients were randomly allocated in a 1:1 ratio to undergo implantation of an arteriovenous coupler device plus current pharmaceutical treatment or to maintain current treatment alone ( control ) .
METHODS	The primary endpoint was mean change from baseline in office and 24 h ambulatory systolic blood pressure at 6 months .
METHODS	Analysis was by modified intention to treat ( all patients remaining in follow-up at 6 months ) .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01642498 .
RESULTS	83 ( 43 % ) of 195 patients screened were assigned arteriovenous coupler therapy ( n = 44 ) or normal care ( n = 39 ) .
RESULTS	Mean office systolic blood pressure reduced by 269 ( SD 239 ) mm Hg in the arteriovenous coupler group ( p < 00001 ) and by 37 ( 212 ) mm Hg in the control group ( p = 031 ) .
RESULTS	Mean systolic 24 h ambulatory blood pressure reduced by 135 ( 188 ) mm Hg ( p < 00001 ) in arteriovenous coupler recipients and by 05 ( 158 ) mm Hg ( p = 086 ) in controls .
RESULTS	Implantation of the arteriovenous coupler was associated with late ipsilateral venous stenosis in 12 ( 29 % ) of 42 patients and was treatable with venoplasty or stenting .
CONCLUSIONS	Arteriovenous anastomosis was associated with significantly reduced blood pressure and hypertensive complications .
CONCLUSIONS	This approach might be a useful adjunctive therapy for patients with uncontrolled hypertension .
BACKGROUND	ROX Medical .

###24662443
OBJECTIVE	To investigate the incidence of incomplete stent apposition and to explore the impact of the presence of thrombus and protruding plaque after stent implantation on neointima formation at follow-up in ST-segment elevation myocardial infarction ( STEMI ) patients with serial optical frequency domain imaging ( OFDI ) investigations .
RESULTS	In a multi-centre study , 141 patients with ST elevation myocardial infarction < 12 h from onset were randomized to either PPCI with thrombectomy ( TB ) using an Eliminate catheter ( TB : n = 71 ) or without TB ( non-TB : n = 70 ) .
RESULTS	OFDI after drug-eluting stenting was performed using TERUMO OFDI system .
RESULTS	Per protocol , at follow-up 49 patients segments were reimaged .
RESULTS	At post-procedure and follow-up , there were no differences in stent and lumen areas between the two groups .
RESULTS	At follow-up , per strut-level analysis , percentage of incompletely apposed struts was 0.42 0.94 vs. 0.38 0.77 % ( P = 0.76 ) , and percentage of covered struts was 92.7 7.2 vs. 94.4 9.2 % ( P = 0.47 ) in the TB and non-TB groups , respectively .
RESULTS	There was a positive correlation between intra-stent structure ( ISS ) volume at post-procedure and the neointima volume at 6-month follow-up ( Pearson 's r = 0.409 , P = 0.04 ) .
RESULTS	Up to 12 months , there have been two and four patients having target vessel failure in the TB and in the non-TB groups , respectively .
CONCLUSIONS	In patients with STEMI , there were no significant differences in OFDI parameters between TB and non-TB groups at both post-procedure and 6-month follow-up .
CONCLUSIONS	However , ISS volume at post-procedure was positively associated with neointimal volume at 6-month follow-up .

###25140597
OBJECTIVE	To investigate whether there is any effect resulting from preconditioning with nutraceutical supplementation containing arginine and oil mixes with high 9:6 ratio and low 6:3 ratio containing EPA and DHA , ALA fatty acids on inflammatory mediators , antioxidant and lipid profile modulation in surgical trauma .
METHODS	Twenty-six men scheduled for radical prostatectomy were randomized into three groups and treated as follows : Group 1 ( skim milk , 0 % fat ) , Group 2 ( supplement with 6:3 ratio of 8:1 and arginine ) and Group 3 ( supplement with high 9:6 ratio of 3.2:1 and low 6:3 ratio of 1.4:1 and arginine ) .
METHODS	Patients received skin milk or supplements twice a day ( 200 ml ) during five days prior to surgery .
METHODS	Peripheral venous blood samples were collected at three different timepoints : five days before surgery ( PRE ) , before anesthesia induction ( IND ) and on the 2nd postoperative day ( POS ) .
METHODS	Parameters analyzed included inflammatory cytokines ( IL-1 , IL-6 , IL-8 and TNF - ) , antioxidants ( catalase ) , lipid profile and heat shock protein ( HSP-27 ) .
RESULTS	There were no significant differences between groups on inflammatory mediators and antioxidant parameters .
RESULTS	However , lipid profile values ( Cholesterol , LDL , Triglycerides , VLDL ) , were significantly different .
CONCLUSIONS	Preconditioning with arginine and oil mixes containing high 9:6 ratio and low 6:3 ratio , has no effects on inflammatory mediators and oxidative stress in patients undergoing radical prostatectomy .
CONCLUSIONS	Reduction of cholesterol , triglycerides , LDL and VLDL profiles may be related to the trauma effect .

###24432923
OBJECTIVE	We tested the efficacy of a sexual risk-reduction intervention for men in South Africa , where heterosexual exposure is the main mode of HIV transmission .
METHODS	Matched-pairs of neighborhoods in Eastern Cape Province , South Africa , were randomly selected and within pairs randomized to 1 of 2 interventions based on social cognitive theory and qualitative research : HIV/sexually transmitted infection ( STI ) risk-reduction , targeting condom use , or attention-matched control , targeting health issues unrelated to sexual risks .
METHODS	Sexually active men aged 18 to 45 years were eligible .
METHODS	The primary outcome was consistent condom use in the past 3 months .
RESULTS	Of 1181 participants , 1106 ( 93.6 % ) completed the 12-month follow-up .
RESULTS	HIV and STI risk-reduction participants had higher odds of reporting consistent condom use ( odds ratio [ OR ] = 1.32 ; 95 % confidence interval [ CI ] = 1.03 , 1.71 ) and condom use at last vaginal intercourse ( OR = 1.40 ; 95 % CI = 1.08 , 1.82 ) than did attention-control participants , adjusting for baseline prevalence .
RESULTS	No differences were observed on unprotected intercourse or multiple partnerships .
RESULTS	Findings did not differ for sex with steady as opposed to casual partners .
CONCLUSIONS	Behavioral interventions specifically targeting men can contribute to efforts to reduce sexual risk behaviors in South Africa .

###25315644
BACKGROUND	Because of the deceased donor organ shortage , more kidney patients are considering whether to receive kidneys from family and friends , a process called living donor kidney transplantation ( LDKT ) .
BACKGROUND	Although Blacks and Hispanics are 3.4 and 1.5 times more likely , respectively , to develop end stage renal disease ( ESRD ) than Whites , they are less likely to receive LDKTs .
BACKGROUND	To address this disparity , a new randomized controlled trial ( RCT ) will assess whether Black , Hispanic , and White transplant patients ' knowledge , readiness to pursue LDKT , and receipt of LDKTs can be increased when they participate in the Your Path to Transplant ( YPT ) computer-tailored intervention .
METHODS	Nine hundred Black , Hispanic , and White ESRD patients presenting for transplant evaluation at University of California , Los Angeles Kidney and Pancreas Transplant Program ( UCLA-KPTP ) will be randomly assigned to one of two education conditions , YPT or Usual Care Control Education ( UC ) .
METHODS	As they undergo transplant evaluation , patients in the YPT condition will receive individually-tailored telephonic coaching sessions , feedback reports , video and print transplant education resources , and assistance with reducing any known socioeconomic barriers to LDKT .
METHODS	Patients receiving UC will only receive transplant education provided by UCLA-KPTP .
METHODS	Changes in transplant knowledge , readiness , pros and cons , and self-efficacy to pursue LDKT will be assessed prior to presenting at the transplant center ( baseline ) , during transplant evaluation , and 4 - and 8-months post-baseline , while completion of transplant evaluation and receipt of LDKTs will be assessed at 18-months post-baseline .
METHODS	The RCT will determine , compared to UC , whether Black , Hispanic , and White patients receiving YPT increase in their readiness to pursue LDKT and transplant knowledge , and become more likely to complete transplant medical evaluation and pursue LDKT .
METHODS	It will also examine how known patient , family , and healthcare system barriers to LDKT act alone and in combination with YPT to affect patients ' transplant decision-making and behavior .
METHODS	Statistical analyses will be performed under an intent-to-treat approach .
CONCLUSIONS	At the conclusion of the study , we will have assessed the effectiveness of an innovative and cost-effective YPT intervention that could be utilized to tailor LDKT discussion and education based on the needs of individual patients of different races in many healthcare settings .
BACKGROUND	ClinicalTrials.gov , number NCT02181114 .

###24622005
OBJECTIVE	The aim of this study was to compare clinical outcomes , resource utilization , and health-related quality of life between Canadian and U.S. patients enrolled in ASCEND-HF ( Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure ) .
OBJECTIVE	A further aim was to supplement the within-trial analysis with a contemporaneous population-based comparison of all patients hospitalized with primary diagnoses of heart failure ( HF ) in the 2 countries .
BACKGROUND	Little is known about intercountry differences in outcomes of patients with HF in Canada and the United States .
METHODS	Trial patients consisted of 465 Canadian and 2,684 U.S. patients enrolled in ASCEND-HF .
METHODS	Population-level cohorts consisted of 1.9 million U.S. and 81,016 Canadians hospitalized for HF in 2007 and2008 .
RESULTS	Canadian patients in ASCEND-HF were older , were more likely to be white , and had lower body weights and blood pressures than U.S. patients .
RESULTS	Canadians also had lower baseline-adjusted odds of 30-day mortality ( odds ratio : 0.46 ; 95 % confidence interval : 0.23 to 0.92 ) and better health-related quality of life than U.S. patients .
RESULTS	In both countries , trial patients differed significantly from population-level cohorts .
RESULTS	In contrast to ASCEND-HF , unadjusted in-hospital mortality at the population level was significantly lower in the United States ( 3.4 % ) compared with Canada ( 11.1 % ) ( p < 0.01 ) .
CONCLUSIONS	Intercountry differences in outcomes of patients hospitalized with HF differed significantly between trial and population cohorts .
CONCLUSIONS	Further study on how cardiac care is delivered in the 2 countries and how it influences the results of clinical trials and population-level outcomes , especially in the long term , is warranted .
CONCLUSIONS	( A Study Testing the Effectiveness of Nesiritide in Patients With Acute Decompensated Heart Failure ; NCT00475852 ) .

###25249361
BACKGROUND	Roughly one in ten persons in the industrialized world suffers from hip osteoarthritis , a disease for which there is no cure .
BACKGROUND	The goal of conservative therapy is to relieve symptoms , preferably with methods that let patients assume responsibility for their own treatment , e.g. , physical training .
METHODS	In a randomized controlled trial , we studied the effectiveness of twelve weeks of exercise therapy in patients with hip osteoarthritis ( THKo ) , compared to no treatment ( control group ) and placebo ultrasound treatment of the hip ( placebo ultrasound group ) .
METHODS	The primary endpoint was a comparison of the pain scores of the intervention versus control groups on the generic SF-36 health questionnaire .
METHODS	Secondary endpoints included comparisons across all three study groups of scores on the 7 other scales of the SF-36 and on the pain , physical function , and stiffness scales of the osteoarthritis-specific WOMAC Index .
METHODS	The statistical analysis was performed with ANCOVA , with baseline values as a covariate .
METHODS	Between-group effects were subsequently tested pairwise ( two-tailed t-tests , alpha = 0.05 ) .
RESULTS	As for the primary endpoint , pain reduction was significantly greater in the intervention than in the control group ( mean difference 5.7 points , 95 % confidence interval [ CI ] 0.4-11 .1 points , p = 0.034 ) .
RESULTS	The comparisons across all three study groups ( i.e. , secondary endpoints , with 71 subjects in the intervention group , 68 in the control group , and 70 in the placebo group ) revealed no significant between-group effects with respect to the SF-36 .
RESULTS	On the WOMAC Index , however , statistically significant differences were found for pain reduction between the intervention and control group ( mean difference 7.4 points , 95 % CI 3.0-11 .8 , p = 0.001 ) and between the intervention and placebo group ( mean difference 5.1 points , 95 % CI 0.7-9 .4 , p = 0.024 ) .
RESULTS	Comparable mean differences were also found for functional improvement .
CONCLUSIONS	Twelve weeks of exercise therapy in hip osteoarthritis patients of normal vitality reduced pain and improved physical function .
CONCLUSIONS	No significant improvement was found in these patients ' general health-related quality of life .

###25278336
BACKGROUND	The McKenzie method is widely used as an active intervention in the treatment of patients with nonspecific low back pain .
BACKGROUND	Although the McKenzie method has been compared with several other interventions , it is not yet known whether this method is superior to placebo in patients with chronic low back pain .
OBJECTIVE	The purpose of this trial is to assess the efficacy of the McKenzie method in patients with chronic nonspecific low back pain .
METHODS	An assessor-blinded , 2-arm , randomized placebo-controlled trial will be conducted .
METHODS	This study will be conducted in physical therapy clinics in So Paulo , Brazil .
METHODS	The participants will be 148 patients seeking care for chronic nonspecific low back pain .
METHODS	Participants will be randomly allocated to 1 of 2 treatment groups : ( 1 ) McKenzie method or ( 2 ) placebo therapy ( detuned ultrasound and shortwave therapy ) .
METHODS	Each group will receive 10 sessions of 30 minutes each ( 2 sessions per week over 5 weeks ) .
METHODS	The clinical outcomes will be obtained at the completion of treatment ( 5 weeks ) and at 3 , 6 , and 12 months after randomization .
METHODS	The primary outcomes will be pain intensity ( measured with the Pain Numerical Rating Scale ) and disability ( measured with the Roland-Morris Disability Questionnaire ) at the completion of treatment .
METHODS	The secondary outcomes will be pain intensity ; disability and function ; kinesiophobia and global perceived effect at 3 , 6 , and 12 months after randomization ; and kinesiophobia and global perceived effect at completion of treatment .
METHODS	The data will be collected by a blinded assessor .
CONCLUSIONS	Therapists will not be blinded .
CONCLUSIONS	This will be the first trial to compare the McKenzie method with placebo therapy in patients with chronic nonspecific low back pain .
CONCLUSIONS	The results of this study will contribute to better management of this population .

###24239201
OBJECTIVE	This study sought to evaluate the clinical relevance of potential clopidogrel drug-drug interactions .
BACKGROUND	Some studies have demonstrated that statins and calcium-channel blockers ( CCBs ) may attenuate the pharmacodynamic effects of clopidogrel .
METHODS	The TRITON-TIMI 38 ( Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition With Prasugrel-Thrombolysis in Myocardial Infarction 38 ) enrolled 13,608 patients with an acute coronary syndrome ( ACS ) and planned percutaneous coronary intervention ( PCI ) , and randomized them to clopidogrel or prasugrel .
METHODS	Use of a statin or CCB was left to the discretion of the treating physician .
METHODS	A multivariable Cox model with propensity score was employed to evaluate the association between statin or CCB use and clinical outcomes .
RESULTS	Of the 6,795 subjects assigned to clopidogrel , 4,794 ( 70.6 % ) were on a CYP3A4-metabolized statin , and 966 ( 14.2 % ) were on a CCB at randomization .
RESULTS	The risk of cardiovascular ( CV ) death , myocardial infarction ( MI ) , or stroke was similar regardless of baseline use of statins ( adjusted hazard ratio [ HR ] : 1.02 , 95 % confidence interval [ CI ] : 0.85 to 1.22 ) or CCBs ( adjusted HR : 1.16 ; 95 % CI : 0.94 to 1.43 ) in clopidogrel-treated patients .
RESULTS	Further , the combined use of a CCB and atorvastatin 80 mg daily ( adjusted HR : 0.82 ; 95 % CI : 0.37 to 1.84 ) , or a CCB , statin , and proton pump inhibitor ( adjusted HR : 1.04 ; 95 % CI : 0.70 to 1.54 ) were not associated with an increased risk of CV death , MI , or stroke .
RESULTS	The use of statins or CCBs did not modify the relative efficacy of prasugrel versus clopidogrel for the primary endpoint ( p for interaction = 0.43 , 0.55 , respectively ) .
CONCLUSIONS	In patients with ACS undergoing PCI , the use of statins or CCBs was not associated with an increased risk of CV events in clopidogrel-treated patients .
CONCLUSIONS	Consistent results were observed when the drugs were administered alone , together , or in combination with proton pump inhibitors .

###25048952
OBJECTIVE	This is a phase II multicentre study to investigate the efficacy and safety of avatrombopag ( E5501 ) , an investigational second-generation thrombopoietin receptor agonist , administered one week prior to elective procedures in patients with thrombocytopenia secondary to cirrhosis .
METHODS	Adults with cirrhosis and platelet counts 10 to 5810 ( 9 ) / L were randomized to placebo or avatrombopag in two sequential cohorts .
METHODS	Cohort A : placebo vs. one of 3 different doses ( 100mg loading dose followed by 20 , 40 , or 80 mg/day on days 2-7 ) of a first-generation avatrombopag formulation .
METHODS	Cohort B : placebo vs. one of 2 different doses ( 80 mg loading dose followed by 10 mg/day for days 2-7 , or 20mg/day for days 2-4 ) of a second-generation avatrombopag formulation .
METHODS	Primary end point was achievement of a platelet increase of 2010 ( 9 ) / L from baseline and > 5010 ( 9 ) / L at least once during days 4-8 .
RESULTS	A total of 130 patients were randomized : 93 patients ( 51 , cohort A ; 42 , cohort B ) to avatrombopag and 37 ( 16 , cohort A ; 21 cohort B ) to placebo .
RESULTS	The primary end point was achieved by 49.0 % of treated patients in cohort A and 47.6 % in cohort B compared to 6.3 % and 9.5 % of controls ; a dose response was seen .
RESULTS	Each avatrombopag regimen had a higher proportion of responders compared with their respective cohort placebo arms ( p < 0.01 ) , except for the 100/40 mg group in cohort A ( p = 0.17 ) .
RESULTS	The most common adverse events were nausea , fatigue , and headache .
RESULTS	One patient in the ( 100/80 ) avatrombopag group , without a Doppler assessment at screening was diagnosed with portal vein thrombosis during post-treatment follow-up .
CONCLUSIONS	In this study avatrombopag was generally well-tolerated and increased platelet counts in patients with cirrhosis undergoing elective invasive procedures .

###25799858
BACKGROUND	Accessibility of the Internet allows obtaining information on different areas of life , including the impact of smoking , alcohol consumption and energy drinks on health .
BACKGROUND	Environmental exposure to tobacco smoke and active smoking are a serious risk for women 's health , especially for women in reproductive age and children at any time in their lives .
BACKGROUND	Alcohol is a risk factor for the development of general diseases , and consumed by pregnant women has a toxic effect on the body of women and a child in the prenatal period .
BACKGROUND	Due to the increased consumption of energy drinks containing among others nervous system stimulants and carbohydrates , their consumption should be a conscious choice of the consumers .
BACKGROUND	Knowledge of the health risks resulting from the lifestyle can be a decisive factor for the implementation of health behaviour .
BACKGROUND	The aim of the study was to determine the sources from which men and women acquire information concerning the effects of cigarette smoking , alcohol consumption and energy drinks on health .
BACKGROUND	The respondents interest in the above mentioned subjects was also evaluated .
METHODS	The survey study was carried out in a group of 160 persons ( 114 women and 46 men ) , aged 19-60 years , randomly selected from the patients presenting to the Department of Conservative Dentistry with Endodontics of the Medical University of Lublin .
METHODS	An author 's questionnaire was prepared for this research .
METHODS	The data were analyzed statistically with the use of Pearson 's X2 test .
METHODS	Statistically significant test values were those with p < 0.05 .
RESULTS	The internet was a source of information about the impact of smoking cigarettes on health for 52.63 % women and 56.52 % men , about the alcohol effect on health for 57.02 % women and 45.65 % men , while about energy drinks for 61.40 % of women and 47.83 % men .
RESULTS	Differences between sex of the respondents and indicated source of information were not statistically significant .
RESULTS	Obtaining information from television programmes on the impact of smoking on health reported 70.18 % of women and 63.04 % of men , about alcohol consumption - 66.67 % women and 58.70 % men respectively .
RESULTS	There was no statistically significant correlation between sex of the respondents and obtaining information concerning cigarette smoking and alcohol consumption .
RESULTS	Women showed significantly more frequently TV programmes as a source of information about energy drinks ( 61.40 % ) compared to males ( 43.48 % ) ( X2 = 4.28 , p < 0.05 ) .
RESULTS	Interest in the subject of the impact of smoking , alcohol consumption and energy drinks on health was not dependent on sex of the respondents .
CONCLUSIONS	Most women acquire knowledge about the effects of cigarette smoking , alcohol consumption and energy drinks on health from TV programmes , although the internet is an increasingly important source of information in this respect .

###24311553
BACKGROUND	Despite depressive disorders being very common there has been little research to guide primary care physicians on the choice of treatment for patients with mild to moderate depression .
OBJECTIVE	To evaluate the efficacy of interpersonal counselling compared with selective serotonin reuptake inhibitors ( SSRIs ) , in primary care attenders with major depression and to identify moderators of treatment outcome .
METHODS	A randomised controlled trial in nine centres ( DEPICS , Australian New Zealand Clinical Trials Registry number : ACTRN12608000479303 ) .
METHODS	The primary outcome was remission of the depressive episode ( defined as a Hamilton Rating Scale for Depression score 7 at 2 months ) .
METHODS	Daily functioning was assessed using the Work and Social Adjustment Scale .
METHODS	Logistic regression models were used to identify moderators of treatment outcome .
RESULTS	The percentage of patients who achieved remission at 2 months was significantly higher in the interpersonal counselling group compared with the SSRI group ( 58.7 % v. 45.1 % , P = 0.021 ) .
RESULTS	Five moderators of treatment outcome were found : depression severity , functional impairment , anxiety comorbidity , previous depressive episodes and smoking habit .
CONCLUSIONS	We identified some patient characteristics predicting a differential outcome with pharmacological and psychological interventions .
CONCLUSIONS	Should our results be confirmed in future studies , these characteristics will help clinicians to define criteria for first-line treatment of depression targeted to patients ' characteristics .

###25532971
BACKGROUND	To identify distinct groups of patients with fibromyalgia ( FM ) with respect to multiple outcome measures .
METHODS	Data from 631 duloxetine-treated women in 4 randomized , placebo-controlled trials were included in a cluster analysis based on outcomes after up to 12 weeks of treatment .
METHODS	Corresponding classification rules were constructed using a classification tree method .
METHODS	Probabilities for transitioning from baseline to Week 12 category were estimated for placebo and duloxetine patients ( Ntotal = 1188 ) using logistic regression .
RESULTS	Five clusters were identified , from `` worst '' ( high pain levels and severe mental/physical impairment ) to `` best '' ( low pain levels and nearly normal mental/physical function ) .
RESULTS	For patients with moderate overall severity , mental and physical symptoms were less correlated , resulting in 2 distinct clusters based on these 2 symptom domains .
RESULTS	Three key variables with threshold values were identified for classification of patients : Brief Pain Inventory ( BPI ) pain interference overall scores of < 3.29 and < 7.14 , respectively , a Fibromyalgia Impact Questionnaire ( FIQ ) interference with work score of < 2 , and an FIQ depression score of 5 .
RESULTS	Patient characteristics and frequencies per baseline category were similar between treatments ; > 80 % of patients were in the 3 worst categories .
RESULTS	Duloxetine patients were significantly more likely to improve after 12 weeks than placebo patients .
RESULTS	A sustained effect was seen with continued duloxetine treatment .
CONCLUSIONS	FM patients are heterogeneous and can be classified into distinct subgroups by simple descriptive rules derived from only 3 variables , which may guide individual patient management .
CONCLUSIONS	Duloxetine showed higher improvement rates than placebo and had a sustained effect beyond 12 weeks .

###24521630
OBJECTIVE	The symptoms of celiac disease ( CD ) are varied and metabolic bone disease ( MBD ) is less recognized amongst all manifestations in CD patients .
OBJECTIVE	Bone disease in CD is attributed to secondary hyperparathyroidism , which in turn is associated with increased bone remodelling .
OBJECTIVE	Improvement in bone mineral density ( BMD ) with gluten free diet ( GFD ) is known , but the data on efficacy of bisphosphonates in CD patients are limited .
OBJECTIVE	Bisphosphonates being a potent inhibitor of bone resorption may be useful in patients with CD having low BMD .
OBJECTIVE	The aim of the present investigation was to study the effect of zoledronic acid on BMD in CD patients .
METHODS	A total of 28 CD patients were randomized to receive GFD , calcium and cholecalciferol ( group A ) , and zoledronic acid ( group B ) .
METHODS	Baseline biochemical tests and T-score by dual energy x-ray absorptiometer were done and repeated after 12 months .
RESULTS	The T-score showed improvement in the control arm ( group A ) from -3.31 1.46 to -2.12 1.44 , a gain of 35.9 per cent ( P < 0.05 ) and in drug arm ( group B ) -2.82 1.27 to -1.06 1.84 , registering a gain of 62.4 per cent ( P < 0.001 ) .
RESULTS	However , there was no difference in improvement of T-score in zoledronic acid group as compared to the control group .
CONCLUSIONS	Administration of zoledronic acid was not found to be better than GFD alone in increasing BMD in CD patients with low BMD in this pilot study .

###24472854
BACKGROUND	Web-based computer-tailored interventions for multiple health behaviors can have a significant public health impact .
BACKGROUND	Yet , few randomized controlled trials have tested this assumption .
OBJECTIVE	The objective of this paper was to test the effects of a sequential and simultaneous Web-based tailored intervention on multiple lifestyle behaviors .
METHODS	A randomized controlled trial was conducted with 3 tailoring conditions ( ie , sequential , simultaneous , and control conditions ) in the Netherlands in 2009-2012 .
METHODS	Follow-up measurements took place after 12 and 24 months .
METHODS	The intervention content was based on the I-Change model .
METHODS	In a health risk appraisal , all respondents ( N = 5055 ) received feedback on their lifestyle behaviors that indicated whether they complied with the Dutch guidelines for physical activity , vegetable consumption , fruit consumption , alcohol intake , and smoking .
METHODS	Participants in the sequential ( n = 1736 ) and simultaneous ( n = 1638 ) conditions received tailored motivational feedback to change unhealthy behaviors one at a time ( sequential ) or all at the same time ( simultaneous ) .
METHODS	Mixed model analyses were performed as primary analyses ; regression analyses were done as sensitivity analyses .
METHODS	An overall risk score was used as outcome measure , then effects on the 5 individual lifestyle behaviors were assessed and a process evaluation was performed regarding exposure to and appreciation of the intervention .
RESULTS	Both tailoring strategies were associated with small self-reported behavioral changes .
RESULTS	The sequential condition had the most significant effects compared to the control condition after 12 months ( T1 , effect size = 0.28 ) .
RESULTS	After 24 months ( T2 ) , the simultaneous condition was most effective ( effect size = 0.18 ) .
RESULTS	All 5 individual lifestyle behaviors changed over time , but few effects differed significantly between the conditions .
RESULTS	At both follow-ups , the sequential condition had significant changes in smoking abstinence compared to the simultaneous condition ( T1 effect size = 0.31 ; T2 effect size = 0.41 ) .
RESULTS	The sequential condition was more effective in decreasing alcohol consumption than the control condition at 24 months ( effect size = 0.27 ) .
RESULTS	Change was predicted by the amount of exposure to the intervention ( total visiting time : beta = -.06 ; P = .01 ; total number of visits : beta = -.11 ; P < .001 ) .
RESULTS	Both interventions were appreciated well by respondents without significant differences between conditions .
CONCLUSIONS	Although evidence was found for the effectiveness of both programs , no simple conclusive finding could be drawn about which intervention mode was more effective .
CONCLUSIONS	The best kind of intervention may depend on the behavior that is targeted or on personal preferences and motivation .
CONCLUSIONS	Further research is needed to identify moderators of intervention effectiveness .
CONCLUSIONS	The results need to be interpreted in view of the high and selective dropout rates , multiple comparisons , and modest effect sizes .
CONCLUSIONS	However , a large number of people were reached at low cost and behavioral change was achieved after 2 years .
BACKGROUND	Nederlands Trial Register : NTR 2168 ; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2168 ( Archived by WebCite at http://www.webcitation.org/6MbUqttYB ) .

###24365196
BACKGROUND	Very few data exist on the long-term follow-up of patients with intermediate nonobstructive saphenous vein graft ( SVG ) lesions .
BACKGROUND	The purpose of this study was to evaluate the 5-year clinical outcomes of the patients enrolled in the Moderate Vein Graft Lesion Stenting With the Taxus Stent and Intravascular Ultrasound ( VELETI ) and the factors associated with SVG disease progression and outcomes .
METHODS	Patients with 1 intermediate SVG lesion ( 30 % -60 % diameter stenosis ) were randomized to either stenting the SVG lesion with a paclitaxel-eluting stent ( PES group , n = 30 ) or to medical treatment alone ( MT group , n = 27 ) .
METHODS	All patients were followed yearly up to 5 years .
RESULTS	Major adverse cardiac events ( MACEs ) ( cardiac death , myocardial infarction [ MI ] , revascularization ) related to the target SVG lesion tended to be lower in the PES group ( 17 % vs 33 % ; P = 0.146 ) due to a lower lesion revascularization rate ( 13 % vs 33 % ; P = 0.072 ) , with no difference in cardiac death or MI between groups .
RESULTS	MACEs related to the target SVG and global MACEs were similar between groups ( P > 0.20 for both ) .
RESULTS	A higher cholesterol level at baseline was the only independent predictive factor of MACEs related to the target SVG ( P = 0.016 ) .
CONCLUSIONS	Over a 5-year period , one third of intermediate lesions in old SVGs progressed , leading to a cardiac event .
CONCLUSIONS	Stenting these lesions with PESs tended to improve clinical outcomes by reducing lesion progression but not SVG failure .
CONCLUSIONS	Higher cholesterol levels were associated with SVG disease progression and clinical events .
CONCLUSIONS	This pilot study provides the basis for a larger trial to determine the efficacy of intermediate SVG lesion plaque sealing .

###25430446
BACKGROUND	Airway management is crucial in clinical anesthesia .
BACKGROUND	Many complications associated with airway management result from unexpected difficult airway , but predicting a difficult airway is a major challenge .
BACKGROUND	We investigated the efficacy of a new combined model including radiological indicators to predict difficult airway in patients undergoing surgery for cervical spondylosis , a population with a high incidence of difficult airway .
METHODS	We randomly enrolled 303 patients scheduled for elective surgery for cervical spondylosis at Peking University Third Hospital between August 2012 and March 2013 .
METHODS	Preoperatively , patients were evaluated for difficult airway according to a clinical index and parameters on lateral cervical radiographs and magnetic resonance images .
METHODS	Difficult airway was defined as Cormack-Lehane grades III-IV .
METHODS	Logistic regression was used to identify a combined ( clinical and radiological ) model for difficult airway .
METHODS	A receiver operating characteristic ( ROC ) curve was used to describe the effectiveness of prediction .
RESULTS	We identified three clinical predictive factors using the ROC curve : mouth opening , sternomental distance , and neck mobility .
RESULTS	We created a clinical model using three factors : gender , age , and mouth opening , with odds ratios ( OR ) of 0.370 , 1.034 , and 0.358 , respectively .
RESULTS	Using the clinical and radiological parameters , we formulated a combined model with five risk factors : gender , mouth opening , atlanto-occipital gap , the angle from the second to sixth cervical vertebraes in the neutral position , and the angle difference of d ( the angle between the laryngeal axis and the epiglottic axis ) from the neutral position to extension ( OR : 0.107 , 0.355 , 0.846 , 1.057 , and 0.952 , respectively ) .
RESULTS	The sensitivity and specificity of the combined model were 80.0 % and 65.7 % , respectively , and the ROC curve confirmed that the combined model was better than any single clinical predictor and the clinical model .
CONCLUSIONS	The efficacy of the combined model including both clinical and radiological indicators was better than any single clinical predictor or the clinical model in patients undergoing elective surgery for cervical spondylosis .

###24553532
BACKGROUND	In medical settings , motivational interviewing-based `` brief intervention '' ( BI ) counseling reduces alcohol-related risk-taking behavior and harm in high-risk populations .
BACKGROUND	Individuals arrested for driving under the influence of alcohol ( DUI ) are another at-risk population .
BACKGROUND	We sought to determine whether a BI administered shortly after a first DUI arrest might decrease problematic drinking behavior .
METHODS	We conducted a single-center , parallel-group , double-blinded superiority randomized trial ( NCT01270217 ) , enrolling first-time DUI arrestees at a county jail from December 2010 through April 2011 .
METHODS	Before their release , we randomized participants by computer-generated sequence to either a single BI or no discussion .
METHODS	We assessed 90-day change in Alcohol Use Disorders Identification Test ( AUDIT ) scores ( range 0-40 , higher values indicating more problematic drinking ) as the primary outcome .
RESULTS	We enrolled 200 subjects ( 100 to each arm ) , and 181 ( 90.5 % , 86 control and 95 BI ) completed the 90-day follow-up .
RESULTS	Mean ( SD ) age was 30 ( 10 ) years , and 50 % were men .
RESULTS	Mean ( SD ) blood alcohol concentration upon arrest was 0.14 % ( 0.04 % ) .
RESULTS	Mean ( SD ) baseline AUDIT scores were 8.8 ( 5.8 ) among control subjects and 7.7 ( 6.3 ) among BI subjects .
RESULTS	At 90 days , AUDIT scores decreased by a mean ( SD ) 4.7 ( 5.1 ) units among control subjects and 3.4 ( 5.0 ) among BI subjects ( difference , -1.3 ; 95 % confidence interval [ CI ] , -2.8 to +0.1 ) .
RESULTS	The likelihood of subsequent binge drinking [ relative risk ( RR ) 1.6 ; 95 % CI , 0.8-3 .0 ; BI vs. control ] , abstinence ( RR , 0.9 ; 95 % CI , 0.4-2 .1 ) , alcohol-related injury to self or others ( RR , 0.4 ; 95 % CI , 0.1-2 .4 ) , and seeking treatment ( RR , 1.2 ; 95 % CI , 0.8-1 .7 ) did not differ .
CONCLUSIONS	A single BI counseling session shortly after first-time DUI arrest does not reduce 90-day self-reported drinking behavior or increase seeking treatment for drinking beyond that which occurs without such a discussion .
METHODS	Therapeutic study , level III .

###24389434
BACKGROUND	This randomized open-label phase II study evaluated the efficacy , safety , and tolerability of pazopanib in combination with pemetrexed compared with the standard cisplatin/pemetrexed doublet in patients with previously untreated , advanced , nonsquamous non-small-cell lung cancer .
METHODS	Patients were randomized ( 2:1 ratio ) to receive pemetrexed 500 mg/m ( 2 ) intravenously once every 3 weeks plus either oral pazopanib 800 mg daily or cisplatin 75 mg/m ( 2 ) intravenously once every 3 weeks up to six cycles .
METHODS	All patients received folic acid , vitamin B12 , and steroid prophylaxis .
METHODS	The primary endpoint was progression-free survival ( PFS ) .
RESULTS	The study was terminated after 106 of 150 patients were randomized due to a higher incidence of adverse events leading to withdrawal from the study and severe and fatal adverse events in the pazopanib/pemetrexed arm than in the cisplatin/pemetrexed arm .
RESULTS	At the time enrolment was discontinued , there were three fatal adverse events in the pazopanib/pemetrexed arm , including ileus , tumor embolism , and bronchopneumonia/sepsis .
RESULTS	Treatment with pazopanib/pemetrexed was discontinued resulting in more PFS data censored for patients in the pazopanib/pemetrexed arm than those in the cisplatin/pemetrexed arm .
RESULTS	There was no statistically significant difference between the pazopanib/pemetrexed and cisplatin/pemetrexed arms for PFS ( median PFS , 25.0 versus 22.9 weeks , respectively ; hazard ratio = 0.75 ; 95 % confidence interval , 0.43 % -1.28 % ; p = 0.26 ) or objective response rate ( 23 % versus 34 % , respectively ; 95 % confidence interval , -30.6 % to 7.2 % ; p = 0.21 ) .
CONCLUSIONS	The combination of pazopanib/pemetrexed in first-line treatment of non-small-cell lung cancer showed some antitumor activity but had unacceptable levels of toxicity .

###24382095
OBJECTIVE	This study aims to explore the temporal relationship between age of onset of substance use and criminal activity in women convicted of violent crimes as well as to subdivide them into clinically significant groups to which tailored treatment can be guided .
METHODS	Of the 353 female inmates randomised for this study , 38 ( 10.8 % ) refused to participate and 182 ( 51.6 % ) met inclusion criteria .
METHODS	Data were obtained only from substance-abusing female inmates serving a sentence for robbery or homicide in a female penitentiary in Brazil .
METHODS	Participant information was gathered through face-to-face interviews during which alcohol and drug abuse , impulsiveness levels , depressive symptoms , and criminological aspects were investigated .
RESULTS	Age of first alcohol and drug use significantly preceded the age of onset of criminal activities in the overall sample .
RESULTS	Onset ages of alcohol and drug use problems significantly preceded the beginning of criminal activities in women convicted of homicide only .
RESULTS	Latent Class Analysis resulted in two groups : cluster 1 ( n = 122 ; 67 % ) , early-onset alcohol and drug users ; and cluster 2 ( n = 60 ; 33 % ) , late-onset alcohol and drug users .
RESULTS	Higher depression levels , higher incidence of committing robbery and less official history of recidivism were associated with cluster 1 inmates .
CONCLUSIONS	The temporal relationship between the onset age of alcohol/drug use problems and age of the beginning of criminal activities can set apart women convicted of robbery from those convicted of homicide .
CONCLUSIONS	Further , a distinctive therapeutic approach to early - and late-onset offenders may be valuable .

###24637951
OBJECTIVE	Previous studies suggest cross-sectional associations between a diagnosis of chronic obstructive pulmonary disease ( COPD ) and mild cognitive impairment ( MCI ) .
OBJECTIVE	However , few studies have assessed whether COPD , a potentially modifiable factor , is associated with an increased risk for MCI and whether the relation is specific to the type of MCI .
OBJECTIVE	To investigate whether a diagnosis of COPD and duration of COPD are associated with an increased risk for incident MCI and MCI subtypes ( amnestic MCI [ A-MCI ] and nonamnestic MCI [ NA-MCI ] ) .
METHODS	A prospective population-based cohort from the Mayo Clinic Study on Aging .
METHODS	We included 1425 cognitively normal individuals aged 70 to 89 years who were randomly selected from Olmsted County , Minnesota , on October 1 , 2004 , using the medical records linkage system .
METHODS	At baseline and every 15 months thereafter , participants underwent assessment with a nurse interview , neurologic examination , and neuropsychological testing .
METHODS	A diagnosis of COPD was confirmed via medical record review .
METHODS	A baseline diagnosis of COPD and duration of COPD were examined as risk factors for MCI and MCI subtypes using Cox proportional hazards models and adjusting for demographic variables and medical comorbidities , with age as the time scale .
METHODS	A baseline diagnosis of COPD and duration of COPD .
METHODS	Incident MCI , A-MCI , and NA-MCI .
RESULTS	Of the 1425 participants with normal cognition at baseline , 370 developed incident MCI .
RESULTS	The median duration of follow-up was 5.1 years ( interquartile range , 3.8-5 .4 years ) .
RESULTS	A diagnosis of COPD significantly increased the risk for NA-MCI by 83 % ( hazard ratio , 1.83 [ 95 % CI , 1.04-3 .23 ] ) , but not of any MCI or A-MCI in multivariate analyses .
RESULTS	We found a dose-response relationship such that individuals with COPD duration of longer than 5 years at baseline had the greatest risk for any MCI ( hazard ratio , 1.58 [ 95 % CI , 1.04-2 .40 ] ) and NA-MCI ( 2.58 [ 1.32-5 .06 ] ) .
CONCLUSIONS	A diagnosis of COPD is associated with an increased risk for MCI , particularly NA-MCI .
CONCLUSIONS	We have found a dose-response relationship between COPD duration and risk for MCI .
CONCLUSIONS	These findings highlight the importance of COPD as a risk factor for MCI and may provide a substrate for early intervention to prevent or delay the onset and progression of MCI , particularly NA-MCI .

###24872540
BACKGROUND	Lung cancer screening programs may provide opportunities to reduce smoking rates among participants .
BACKGROUND	This study evaluates the impact of lung cancer screening results on smoking cessation .
METHODS	Data from Lung Screening Study participants in the National Lung Screening Trial ( NLST ; 2002-2009 ) were used to prepare multivariable longitudinal regression models predicting annual smoking cessation in those who were current smokers at study entry ( n = 15489 , excluding those developing lung cancer in follow-up ) .
METHODS	The associations of lung cancer screening results on smoking cessation over the trial period were analyzed .
METHODS	All hypothesis testing used two sided P values .
RESULTS	In adjusted analyses , smoking cessation was strongly associated with the amount of abnormality observed in the previous year 's screening ( P < .0001 ) .
RESULTS	Compared with those with a normal screen , individuals were less likely to be smokers if their previous year 's screen had a major abnormality that was not suspicious for lung cancer ( odds ratio [ OR ] = 0.811 ; 95 % confidence interval [ CI ] = 0.722 to 0.912 ; P < .001 ) , was suspicious for lung cancer but stable from previous screens ( OR = 0.785 ; 95 % CI = 0.706 to 0.872 ; P < .001 ) , or was suspicious for lung cancer and was new or changed from the previous screen ( OR = 0.663 ; 95 % CI = 0.607 to 0.724 ; P < .001 ) .
RESULTS	Differences in smoking prevalence were present up to 5 years after the last screen .
CONCLUSIONS	Smoking cessation is statistically significantly associated with screen-detected abnormality .
CONCLUSIONS	Integration of effective smoking cessation programs within screening programs should lead to further reduction in smoking-related morbidity and mortality .

###25548331
OBJECTIVE	To determine the impact of a vaccination reminder in an electronic health record supplemented with data from an immunization information system ( IIS ) .
METHODS	A noninterruptive influenza vaccination reminder , based on a real-time query of hospital and city IIS , was used at 4 urban , academically affiliated clinics serving a low-income population .
METHODS	Using a randomized cluster-crossover design , each study site had `` on '' and `` off '' period during the fall and winter of 2011-2012 .
METHODS	Influenza vaccination during a clinic visit was assessed for 6-month to 17-year-old patients .
METHODS	To assess sustainability , the reminder was active at all sites during the 2012-2013 season .
RESULTS	In the 2011-2012 season , 8481 unique non-up-to-date children had visits .
RESULTS	Slightly more non-up-to-date children seen when the reminder was ` on ' were vaccinated than when ` off ' ( 76.2 % vs 73.8 % ; P = .027 ) .
RESULTS	Effects were seen in the winter ( 67.9 % vs 62.2 % ; P = .005 ) , not fall ( 76.8 % vs 76.5 % ) .
RESULTS	The reminder also increased documentation of the reason for vaccine non-administration ( 68.1 % vs 41.5 % ; P < .0001 ) .
RESULTS	During the 2011-2012 season , the reminder displayed for 8630 unique visits , and clinicians interacted with it in 83.1 % of cases where patients required vaccination .
RESULTS	During the 2012-2013 season , it displayed for 22248 unique visits ; clinicians interacted with it in 84.8 % of cases .
CONCLUSIONS	An IIS-linked influenza vaccination reminder increased vaccination later in the winter when fewer vaccine doses are usually given .
CONCLUSIONS	Although the reminder did not require clinicians to interact with it , they frequently did ; utilization did not wane over time .

###25326710
BACKGROUND	Parenting programs have been highlighted as a way of supporting and empowering parents .
BACKGROUND	As programs designed to promote children 's health and well-being are scarce , a new health-promotion program , All Children in Focus , has been developed .
BACKGROUND	The purpose of this trial was to evaluate the potential effectiveness of the program in promoting parental self-efficacy and child health and development , as well as to investigate possible moderators of these outcomes .
METHODS	A multicenter randomized waitlist-controlled trial was conducted .
METHODS	The trial included 621 parents with children aged 3-12 years .
METHODS	Parents were randomized to receive the intervention directly or to join a waitlist control group .
METHODS	Parents completed questionnaires at baseline , 2weeks after the intervention , and 6months post-baseline .
METHODS	To evaluate potential effects of the program , as well as any moderating variables , multilevel modeling with a repeated-measures design was applied .
RESULTS	Parents in the intervention group reported that their self-efficacy ( p < .001 ) , as well as their perceptions of children 's health and development ( p < .05 ) , increased 6months post-baseline when compared with parents in the control group .
RESULTS	One variable was found to moderate both outcomes : parents ' positive mental health .
RESULTS	Furthermore , parents ' educational level and number of children moderated parental self-efficacy , while the children 's age moderated child health and development .
RESULTS	Having a poor positive mental health , a university-level education , more than one child in the family , and older children , made the families benefit more .
CONCLUSIONS	In the first randomized controlled trial of All Children in Focus , we found that the program appears to promote both parental self-efficacy and children 's health and development in a general population .
CONCLUSIONS	Additionally , we found that families may benefit differently depending on their baseline characteristics .
CONCLUSIONS	This contributes to an existing understanding of the advantages of offering universal parenting programs as a public health approach to strengthening families .
CONCLUSIONS	However , further research is needed to investigate long-term effects and mediating variables , as well as the potential cost-effectiveness of the program .
BACKGROUND	Current Controlled Trials : ISRCTN70202532 .
BACKGROUND	November 7th 2012 .

###24491065
BACKGROUND	Given the rising number of strokes worldwide , and the large number of individuals left with disabilities after stroke , novel strategies to reduce disability , increase functions in the motor and the cognitive domains , and improve quality of life are of major importance .
BACKGROUND	Physical activity is a promising intervention to address these challenges but , as yet , there is no study demonstrating definite outcomes .
BACKGROUND	Our objective is to assess whether additional treatment in the form of physical fitness-based training for patients early after stroke will provide benefits in terms of functional outcomes , in particular gait speed and the Barthel Index ( co-primary outcome measures ) reflecting activities of daily living ( ADL ) .
BACKGROUND	We will gather secondary functional outcomes as well as mechanistic parameters in an exploratory approach .
METHODS	Our phase III randomised controlled trial will recruit 215 adults with moderate to severe limitations of walking and ADL 5 to 45days after stroke onset .
METHODS	Participants will be stratified for the prognostic variables of `` centre '' , `` age '' , and `` stroke severity '' , and randomly assigned to one of two groups .
METHODS	The interventional group receives physical fitness training delivered as supported or unsupported treadmill training ( cardiovascular active aerobic training ; five times per week , over 4weeks ; each session 50minutes ; total of 20 additional physical fitness training sessions ) in addition to standard rehabilitation treatment .
METHODS	The control intervention consists of relaxation sessions ( non-cardiovascular active ; five times per week week , over 4weeks ; each session 50minutes ) in addition to standard rehabilitation treatment .
METHODS	Co-primary efficacy endpoints will be gait speed ( in m/s , 10m walk ) and the Barthel Index ( 100 points total ) at 3months post-stroke , compared to baseline measurements .
METHODS	Secondary outcomes include standard measures of quality of life , sleep and mood , cognition , arm function , maximal oxygen uptake , and cardiovascular risk factors including blood pressure , pulse , waist-to-hip ratio , markers of inflammation , immunity and the insulin-glucose pathway , lipid profile , and others .
CONCLUSIONS	The goal of this endpoint-blinded , phase III randomised controlled trial is to provide evidence to guide post-stroke physical fitness-based rehabilitation programmes , and to elucidate the mechanisms underlying this intervention .
BACKGROUND	Registered in ClinicalTrials.gov with the Identifier NCT01953549 .

###24565019
BACKGROUND	Community engagement ( CE ) is increasingly promoted for biomedical research conducted in resource poor settings for both intrinsic and instrumental purposes .
BACKGROUND	Given the potential importance of CE , but also complexities and possibility of unexpected negative outcomes , there is need for more documentation of CE processes in practice .
BACKGROUND	We share experiences of formal CE for a paediatric randomized controlled malaria vaccine trial conducted in three sites within Kilifi County , Kenya .
METHODS	Social scientists independent of the trial held in-depth individual interviews with trial researchers ( n = 5 ) , community leaders ( n = 8 ) and parents ( 15 with enrolled children and 4 without ) ; and group discussions with fieldworkers ( n = 6 ) and facility staff ( n = 2 ) .
METHODS	We conducted a survey of participating households ( n = 200 ) and observed over 150 CE activities .
RESULTS	The overall CE plan was similar across the three study sites , although less community-based information in site C. Majority perceived CE activities to clear pre-existing concerns and misconceptions ; increase visibility , awareness of and trust in trial staff .
RESULTS	Challenges included : some community leaders attempting to exert pressure on people to enrol ; local wording in information sheets and consent forms feeding into serious anxieties about the trial ; and concerns about reduced CE over time .
RESULTS	Negative effects of these challenges were mitigated through changes to on-going CE activities , and final information sharing and consent being conducted individually by trained clinical staff .
RESULTS	One year after enrolment , 31 % ( n = 62 ) of participants ' parents reported malaria prevention as the main aim of the activities their children were involved in , and 93 % wanted their children to remain involved .
CONCLUSIONS	The trial teams ' goals for CE were relatively clear from the outset .
CONCLUSIONS	Other actors ' hopes and expectations ( like higher allowances and future employment ) were not openly discussed , but emerged over the course of engagements .
CONCLUSIONS	Encouraging open discussion of all actors ' intentions and goals from the outset takes time , risks raising expectations that can not be met , and is complex .
CONCLUSIONS	However , doing so in future similar trials may allow successes here to be built upon , and some challenges minimized or avoided .
BACKGROUND	ClinicalTrials.gov NCT00866619 ( registration 19-Mar-2009 ) .

###24253779
METHODS	Analysis via computed tomography imaging software .
OBJECTIVE	To determine parameters for ideal intralaminar screw trajectory and the feasibility of screw placement at L3 , L4 , and L5 laminae for pars defect fixation .
BACKGROUND	To our knowledge , no studies provide anatomic parameters for ideal intralaminar screw trajectory for treating spondylolysis .
METHODS	We used advanced imaging software for 3-dimensional interactive viewing to analyze 20 randomly selected normal adolescent lumbar computed tomographic scans .
METHODS	The ideal intralaminar screw trajectory was drawn from the inferior lamina , a point chosen to maximize cortical diameter at the isthmus of the lamina and bisect the pedicle .
METHODS	We measured and evaluated ideal trajectory parameters for percutaneous screw placement for pars defect fixation at the L3 to L5 laminae .
RESULTS	The ideal pathway was the thick portion of the lamina between the inferior edge of the lamina and the pedicle .
RESULTS	This area was close to the inferior articular process ( axial plane ) , becoming more so at progressively caudal levels .
RESULTS	At the ideal trajectory , the mean ( standard deviation ) coronal angle slightly decreased ( L3-L5 ) : 7.3 ( 5.1 ) , 6.6 ( 3.7 ) , and 4.2 ( 2.5 ) , respectively .
RESULTS	The trajectory distance increased from cranial to caudal .
RESULTS	These parameters increased ( L3-L5 ) : mean distance ( transverse plane ) between the starting point and middle of the spinous process , 1.2 ( 0.18 cm ) , 1.3 ( 0.2 cm ) , and 1.6 ( 0.3 cm ) , respectively ; mean screw sagittal angle with respect to the posterior skin , 15.5 ( 5.0 ) , 24.3 ( 6.5 ) , and 43 ( 5.8 ) , respectively ; and mean distance for guide wire entry , 28.8 ( 10.6 cm ) , 20.1 ( 5.4 cm ) , and 11.9 ( 2.1 cm ) , respectively .
CONCLUSIONS	At the ideal screw trajectory , pars fixation by intralaminar screw is uniformly feasible at L3 to L5 laminae , where most patients can accommodate a 4.5-mm screw .
METHODS	2 .

###24433574
BACKGROUND	Female sexual dysfunction is a side effect of selective serotonin reuptake inhibitor ( SSRI ) / serotonin noradrenalin reuptake inhibitor ( SNRI ) therapy .
OBJECTIVE	The aim of this study is to investigate the efficacy of transdermal testosterone ( TT ) as a treatment for SSRI/SNRI-emergent loss of libido .
METHODS	This was a double-blind , randomized , placebo-controlled study .
METHODS	Forty-four women , aged 35-55 years , on a stable dose of SSRI or SNRI with treatment-emergent loss of libido were randomly allocated to treatment with a TT patch delivering 300 mcg of testosterone/day or an identical placebo patch ( Pl ) for 12 weeks .
METHODS	The primary outcome measure was the change in the Sabbatsberg Sexual Self-rating Scale ( SSS ) total score over 12 weeks .
METHODS	The 4-week frequency of Satisfactory Sexual Events ( SSEs ) and the Female Sexual Distress Scale-Revised ( FSDS-R ) were also measured .
RESULTS	At baseline , there were no differences between the treatment groups .
RESULTS	At week 12 , the change in the SSS score did not differ between the two groups .
RESULTS	The increase in the 4-week frequency of SSEs was significantly greater for the TT group than for the Pl group ( an increase of 2.3 events vs. 0.1 , P = 0.02 ) .
RESULTS	The between-group difference in the change in the FSDS-R score approached statistical significance ( P = 0.06 ) .
RESULTS	The mean total serum testosterone level at 12 weeks in the TT group was 2.1 nmol/L .
RESULTS	No women withdrew because of androgenic adverse events .
CONCLUSIONS	TT therapy resulted in a significant increase in the number of SSEs compared with Pl therapy in women with SSRI/SNRI-emergent loss of libido .
CONCLUSIONS	The lack of improvement in the SSS total score may reflect lack of sensitivity of this instrument for the measurement of change in sexual function .
CONCLUSIONS	This provides the first evidence that TT therapy may be a treatment option for women with SSRI/SNRI-emergent loss of libido who need to remain on their antidepressant therapy .

###24947583
OBJECTIVE	The best treatment strategy for a patient with type 2 diabetes who shows pronounced weight gain after the introduction of insulin treatment is unclear .
OBJECTIVE	We determined whether addition of a glucagon-like peptide-1 ( GLP-1 ) analogue could reverse pronounced insulin-associated weight gain while maintaining glycaemic control , and compared this with the most practised strategy , continuation and intensification of standard insulin therapy .
METHODS	In a 26-week , randomised controlled trial ( ELEGANT ) , conducted in the outpatient departments of one academic and one large non-academic teaching hospital in the Netherlands , adult patients with type 2 diabetes with 4 % weight gain during short-term ( 16 months ) insulin therapy received either open-label addition of liraglutide 1.8 mg/day ( n = 26 ) or continued standard therapy ( n = 24 ) .
METHODS	A computer-generated random number list was used to allocate treatments .
METHODS	Participants were evaluated every 4-6 weeks for weight , glycaemic control and adverse events .
METHODS	The primary endpoint was between-group weight difference after 26 weeks of treatment ( intention to treat ) .
RESULTS	Of 50 randomised patients ( mean age 58 years , BMI 33 kg/m ( 2 ) , HbA1c 7.4 % [ 57 mmol/mol ] ) , 47 ( 94 % ) completed the study ; all patients were analysed .
RESULTS	Body weight decreased by 4.5 kg with liraglutide and increased by 0.9 kg with standard therapy ( mean difference -5.2 kg [ 95 % CI -6.7 , -3.6 kg ] ; p < 0.001 ) .
RESULTS	The respective changes in HbA1c were -0.77 % ( -8.4 mmol/mol ) and +0.01 % ( +0.1 mmol/mol ) ( difference -0.74 % [ -8.1 mmol/mol ] ) ( [ 95 % CI -1.08 % , -0.41 % ] [ -11.8 , -4.5 mmol/mol ] ; p < 0.001 ) ; respective changes in insulin dose were -29 U/day and +5 U/day ( difference -33 U/day [ 95 % CI -41 , -25 U/day ] ; p < 0.001 ) .
RESULTS	In five patients ( 19 % ) , insulin could be completely discontinued .
RESULTS	Liraglutide was well tolerated ; no severe adverse events or severe hypoglycaemia occurred .
CONCLUSIONS	In patients with pronounced insulin-associated weight gain , addition of liraglutide to their treatment regimen reverses weight , decreases insulin dose and improves glycaemic control , and hence seems a valuable therapeutic option compared with continuation of standard insulin treatment .
CONCLUSIONS	Trial registration ClinicalTrials.gov NCT01392898 .
CONCLUSIONS	Funding The study was funded by Novo Nordisk .

###24965958
OBJECTIVE	To compare the effectiveness of body weight-supported treadmill training and body weight-supported overground training for improving gait and strength in people with traumatic incomplete tetraplegia .
METHODS	Assessor blinded randomized trial .
METHODS	Rehabilitation institute of a tertiary care teaching hospital in India .
METHODS	Sixteen participants with traumatic motor incomplete tetraplegia and within two years of injury .
METHODS	Participants were randomised to one of two groups : body weight-supported overground training on level ground and body weight-supported treadmill training .
METHODS	Both groups received 30 minutes of gait training per day , five days a week for eight weeks .
METHODS	In addition , both groups received regular rehabilitation which included flexibility , strength , balance , self care and functional training .
METHODS	The primary outcome measure was the Walking Index for Spinal Cord Injury ( / 20 points ) and the secondary outcome was the Lower Extremity Muscle Score ( / 50 points ) .
RESULTS	There was no statistically significant between group differences in the Walking Index for Spinal Cord Injury [ mean difference = 0.3 points ; 95 % CI ( -4.8 to 5.4 ) ; p = 0.748 ] or the Lower Extremity Muscle Score [ mean difference = 0.2 points ; 95 % CI ( -3.8 to 5.1 ) ; p = 0.749 ] .
CONCLUSIONS	Gait training with body weight-supported overground training is comparable to treadmill training for improving locomotion in people with traumatic incomplete tetraplegia .

###25517389
BACKGROUND	Although exercise training is known to promote post-exercise hypotension , there is currently no consistent argument about the effects of manipulating its various components ( intensity , duration , rest periods , types of exercise , training methods ) on the magnitude and duration of hypotensive response .
OBJECTIVE	To compare the effect of continuous and interval exercises on hypotensive response magnitude and duration in hypertensive patients by using ambulatory blood pressure monitoring ( ABPM ) .
METHODS	The sample consisted of 20 elderly hypertensives .
METHODS	Each participant underwent three ABPM sessions : one control ABPM , without exercise ; one ABPM after continuous exercise ; and one ABPM after interval exercise .
METHODS	Systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , mean arterial pressure ( MAP ) , heart rate ( HR ) and double product ( DP ) were monitored to check post-exercise hypotension and for comparison between each ABPM .
RESULTS	ABPM after continuous exercise and after interval exercise showed post-exercise hypotension and a significant reduction ( p < 0.05 ) in SBP , DBP , MAP and DP for 20 hours as compared with control ABPM .
RESULTS	Comparing ABPM after continuous and ABPM after interval exercise , a significant reduction ( p < 0.05 ) in SBP , DBP , MAP and DP was observed in the latter .
CONCLUSIONS	Continuous and interval exercise trainings promote post-exercise hypotension with reduction in SBP , DBP , MAP and DP in the 20 hours following exercise .
CONCLUSIONS	Interval exercise training causes greater post-exercise hypotension and lower cardiovascular overload as compared with continuous exercise .

###24928284
BACKGROUND	Both epidemiological and randomized clinical studies suggest that supplementation with very-long-chain marine polyunsaturated n-3 fatty acids ( n-3 PUFA ) have cardioprotective effects , however these results are not without controversy .
BACKGROUND	Study population , sample-size , type of supplementation and type of endpoint have all varied widely accross different studies.Therefore , the aims of the present study are to evaluate the effect of 2 years supplementation with capsules of very-long chain marine n-3 PUFA on top of standard therapy in elderly patients after acute myocardial infarction ( AMI ) .
BACKGROUND	In addition , special characteristics of this population with regard to prediction of clinical outcome will be investigated .
BACKGROUND	The hypothesis is that this supplementation on top of modern therapy will reduce the occurence of major cardiovascular events ( MACE ) .
BACKGROUND	We present the design of the OMEMI ( OMega-3 fatty acids in Elderly patients with Myocardial Infarction ) study .
METHODS	The OMEMI study is designed as a randomized , placebo-controlled double-blind multicenter trial.Included are patients 70-82 years of age who have sustained AMI .
METHODS	Patients of either gender are eligible .
METHODS	Sample size calculation based on existing literature has resulted in the need for 1400 patients followed for 2 years , based on the assumption that the n-3 PUFA supplementation will reduce MACE with 30 % .
METHODS	The study medication is Pikasol Axellus AS , Norway , 3 capsules ( 1.8 g eicosapentaenoic acid ( EPA ) + docohexaenoic acid ( DHA ) ) per day , and matching placebo is corn oil .
METHODS	The Primary end-point is the composite of total mortality , first non-fatal recurring AMI , stroke and revascularization .
METHODS	Secondary end-point is the occurrence of new onset atrial fibrillation .
METHODS	Extensive biobanking will be performed , including adipose tissue biopsies .
METHODS	Compliance will be assessed by measurements of the fatty acid profile in serum , sampled at inclusion , after 12 months and at the end of study .
CONCLUSIONS	The OMEMI study is scheduled to terminate when the last included patient has been followed for 2 years .
CONCLUSIONS	To the best of our knowledge , the OMEMI study is the first to evaluate the effect of n-3 PUFAs on CVDs and mortality in a high risk elderly population having suffered an acute myocardial infarction .
BACKGROUND	ClinicalTrials.gov , NCT01841944 .

###24998104
OBJECTIVE	A review of all the adjuncts for intravenous regional anaesthesia concluded that there is good evidence to recommend NonSteroidal Anti-Inflammatory agents and pethidine in the dose of 30mg dose as adjuncts to intravenous regional anaesthesia .
OBJECTIVE	But there are no studies to compare pethidine of 30mg dose to any of the NonSteroidal Anti-Inflammatory agents .
METHODS	In a prospective , randomized , double blind study , 45 patients were given intravenous regional anaesthesia with either lignocaine alone or lignocaine with pethidine 30mg or lignocaine with ketprofen 100mg .
METHODS	Fentanyl was used as rescue analgesic during surgery .
METHODS	For the first 6h of postoperative period analgesia was provided by fentanyl injection and between 6 and 24h analgesia was provided by diclofenac tablets .
METHODS	Visual analogue scores for pain and consumption of fentanyl and diclofenac were compared .
RESULTS	The block was inadequate for one case each in lignocaine group and pethidine group , so general anaesthesia was provided .
RESULTS	Time for the first dose of fentanyl required for postoperative analgesia was significantly more in pethidine and ketoprofen groups compared to lignocaine group ( 156.7148.8 and 153.0106.0 vs. 52.152.4 min respectively ) .
RESULTS	Total fentanyl consumption in first 6h of postoperative period was less in pethidine and ketoprofen groups compared to lignocaine group ( 37.529.0 mcg , 38.320.8 mcg vs. 64.227.2 mcg respectively ) .
RESULTS	Consumption of diclofenac tablets was 2.40.7 , 2.50.5 and 2.00.7 in the control , pethidine and ketoprofen group respectively , which was statistically not significant .
RESULTS	Side effects were not significantly different between the groups .
CONCLUSIONS	Both pethidine and ketoprofen are equally effective in providing postoperative analgesia up to 6h , without significant difference in the side effects and none of the adjuncts provide significant analgesia after 6h .

###24768410
BACKGROUND	Contingency management ( CM ) is an efficacious intervention for reducing cigarette smoking .
BACKGROUND	However , CM is rarely adopted as a smoking cessation treatment in the community .
BACKGROUND	This study analyzed the effectiveness of a CM procedure in combination with a cognitive-behavioral treatment ( CBT ) for smoking cessation among treatment-seeking patients from the general population .
METHODS	A total of 92 patients were randomly assigned to one of two treatment conditions : CBT ( N = 49 ) or CBT+CM ( N = 43 ) .
METHODS	The CM procedure included a voucher program through which nicotine abstinence was reinforced on a schedule of escalating magnitude of reinforcement with a reset contingency .
METHODS	Self-reported smoking status was confirmed with both carbon monoxide ( CO ) level in expired air and cotinine levels in urine .
RESULTS	Of the patients who received CBT+CM 97.7 % , completed 6 weeks of treatment , versus 81.6 % of those who received CBT ( p = .03 ) .
RESULTS	At the post-treatment assessment , 95.3 % of the patients assigned to the CBT+CM condition achieved abstinence in comparison to the 59.2 % in the CBT group ( p = .000 ) .
RESULTS	At the one-month follow-up , 72.1 % of the patients who received CBT+CM maintained smoking abstinence , versus 34.7 % in the CBT group ( p = .001 ) .
RESULTS	At the six-month follow-up , 51.2 % of the patients who received CBT+CM maintained smoking abstinence in comparison to the 28.6 % in the CBT group ( p = .04 ) .
CONCLUSIONS	Results from this randomized clinical trial showed that adding CM to a CBT is effective , and is feasible as an intervention approach with treatment-seeking patients in a community setting .

###25422488
OBJECTIVE	To determine the optimal dose and schedule of anthracycline and taxane administration as adjuvant therapy for early-stage breast cancer .
METHODS	A 2 2 factorial design was used to test two hypotheses : ( 1 ) that a novel continuous schedule of doxorubicin-cyclophosphamide was superior to six cycles of doxorubicin-cyclophosphamide once every 2 weeks and ( 2 ) that paclitaxel once per week was superior to six cycles of paclitaxel once every 2 weeks in patients with node-positive or high-risk node-negative early-stage breast cancer .
METHODS	With 3,250 patients , a disease-free survival ( DFS ) hazard ratio of 0.82 for each randomization could be detected with 90 % power with two-sided = .05 .
METHODS	Overall survival ( OS ) was a secondary outcome .
RESULTS	Interim analyses crossed the futility boundaries for demonstrating superiority of both once-per-week regimens and once-every-2-weeks regimens .
RESULTS	After a median follow-up of 6 years , a significant interaction developed between the two randomization factors ( DFS P = .024 ; OS P = .010 ) in the 2,716 patients randomly assigned in the original design , which precluded interpretation of the two factors separately .
RESULTS	Comparing all four arms showed a significant difference in OS ( P = .040 ) but not in DFS ( P = .11 ) , with all treatments given once every 2 weeks associated with the highest OS .
RESULTS	This difference in OS seemed confined to patients with hormone receptor-negative/human epidermal growth factor receptor 2 ( HER2 ) - negative tumors ( P = .067 ) , with no differences seen with hormone receptor-positive/HER2-negative ( P = .90 ) or HER2-positive tumors ( P = .40 ) .
CONCLUSIONS	Patients achieved a similar DFS with any of these regimens .
CONCLUSIONS	Subset analysis suggests the hypothesis that once-every-2-weeks dosing may be best for patients with hormone receptor-negative/HER2-negative tumors .

###24969592
OBJECTIVE	To evaluate the effectiveness of resin-based sealants and glass ionomer sealants on caries prevention in the first permanent molars .
METHODS	A randomized controlled , examiner-blinded , 2-year clinical trial with parallel groups was conducted .
METHODS	A total of 419 children ( 664 first molars ) who had at least one sound first permanent molar with deep fissures or fissures with signs of non-cavitated lesions were recruited .
METHODS	They were randomly allocated into three groups.Helioseal F , a light-cured resin-based sealants was used in group R ( 136 children with 219 first molars ) .
METHODS	FUJI VII , a light-cured glass ionomer sealants was used in group G ( 130 children with 218 first molars ) and group N ( 153 children with 227 first molars ) was blank control.Follow-up examinations were conducted at 6 , 12 , and 24 month after sealing to examine the sealants retention and caries incidence .
METHODS	Chi-square test was used to compare the differences of caries incidence among the 3 groups.Generalized estimating equations ( GEE ) was used to analyze the effective factors of caries incidence .
RESULTS	During the 2-year follow-up period , 3.0 % ( 6/197 ) of the teeth in group R , 6.7 % ( 13/193 ) of the teeth in group G , and 14.7 % ( 29/197 ) of the teeth in group N were diagnosed as having developed a cavitated lesion .
RESULTS	The difference in the incidence of caries among the three groups was significant ( P < 0.05 ) .
RESULTS	No significant difference in caries incidence was found between group R and group G ( P > 0.05 ) .
RESULTS	The tooth-level preventive fractions were 79.6 % for resin-based sealants and 54.4 % for glass ionomer sealants , respectively .
CONCLUSIONS	Both resin-based sealants and glass ionomer sealants can effectively prevent the incidence of caries in the first permanent molars .
CONCLUSIONS	The two sealants have similar caries prevention effect .

###24705119
BACKGROUND	In the Single Ventricle Reconstruction ( SVR ) trial , 1-year transplantation-free survival was better for the Norwood procedure with right ventricle-to-pulmonary artery shunt ( RVPAS ) compared with a modified Blalock-Taussig shunt ( MBTS ) .
BACKGROUND	At 3 years , we compared transplantation-free survival , echocardiographic right ventricular ejection fraction , and unplanned interventions in the treatment groups .
RESULTS	Vital status and medical history were ascertained from annual medical records , death indexes , and phone interviews .
RESULTS	The cohort included 549 patients randomized and treated in the SVR trial .
RESULTS	Transplantation-free survival for the RVPAS versus MBTS groups did not differ at 3 years ( 67 % versus 61 % ; P = 0.15 ) or with all available follow-up of 4.81.1 years ( log-rank P = 0.14 ) .
RESULTS	Pre-Fontan right ventricular ejection fraction was lower in the RVPAS group than in the MBTS group ( 41.75.1 % versus 44.76.0 % ; P = 0.007 ) , and right ventricular ejection fraction deteriorated in RVPAS ( P = 0.004 ) but not MBTS ( P = 0.40 ) subjects ( pre-Fontan minus 14-month mean , -3.258.24 % versus 0.998.80 % ; P = 0.009 ) .
RESULTS	The RVPAS versus MBTS treatment effect had nonproportional hazards ( P = 0.004 ) ; the hazard ratio favored the RVPAS before 5 months ( hazard ratio = 0.63 ; 95 % confidence interval , 0.45-0 .88 ) but the MBTS beyond 1 year ( hazard ratio = 2.22 ; 95 % confidence interval , 1.07-4 .62 ) .
RESULTS	By 3 years , RVPAS subjects had a higher incidence of catheter interventions ( P < 0.001 ) with an increasing HR over time ( P = 0.005 ) : < 5 months , 1.14 ( 95 % confidence interval , 0.81-1 .60 ) ; from 5 months to 1 year , 1.94 ( 95 % confidence interval , 1.02-3 .69 ) ; and > 1 year , 2.48 ( 95 % confidence interval , 1.28-4 .80 ) .
CONCLUSIONS	By 3 years , the Norwood procedure with RVPAS compared with MBTS was no longer associated with superior transplantation-free survival .
CONCLUSIONS	Moreover , RVPAS subjects had slightly worse right ventricular ejection fraction and underwent more catheter interventions with increasing hazard ratio over time .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00115934 .

###24892763
BACKGROUND	The relationship between pneumococcal conjugate vaccine-induced antibody responses and protection against community-acquired pneumonia ( CAP ) and acute otitis media ( AOM ) is unclear .
BACKGROUND	This study assessed the impact of the ten-valent pneumococcal nontypable Haemophilus influenzae protein D conjugate vaccine ( PHiD-CV ) on these end points .
BACKGROUND	The primary objective was to demonstrate vaccine efficacy ( VE ) in a per-protocol analysis against likely bacterial CAP ( B-CAP : radiologically confirmed CAP with alveolar consolidation/pleural effusion on chest X-ray , or non-alveolar infiltrates and C-reactive protein 40 g/ml ) ; other protocol-specified outcomes were also assessed .
RESULTS	This phase III double-blind randomized controlled study was conducted between 28 June 2007 and 28 July 2011 in Argentine , Panamanian , and Colombian populations with good access to health care .
RESULTS	Approximately 24,000 infants received PHiD-CV or hepatitis control vaccine ( hepatitis B for primary vaccination , hepatitis A at booster ) at 2 , 4 , 6 , and 15-18 mo of age .
RESULTS	Interim analysis of the primary end point was planned when 535 first B-CAP episodes , occurring 2 wk after dose 3 , were identified in the per-protocol cohort .
RESULTS	After a mean follow-up of 23 mo ( PHiD-CV , n = 10,295 ; control , n = 10,201 ) , per-protocol VE was 22.0 % ( 95 % CI : 7.7 , 34.2 ; one-sided p = 0.002 ) against B-CAP ( conclusive for primary objective ) and 25.7 % ( 95 % CI : 8.4 % , 39.6 % ) against World Health Organization-defined consolidated CAP .
RESULTS	Intent-to-treat VE was 18.2 % ( 95 % CI : 5.5 % , 29.1 % ) against B-CAP and 23.4 % ( 95 % CI : 8.8 % , 35.7 % ) against consolidated CAP .
RESULTS	End-of-study per-protocol analyses were performed after a mean follow-up of 28-30 mo for CAP and invasive pneumococcal disease ( IPD ) ( PHiD-CV , n = 10,211 ; control , n = 10,140 ) and AOM ( n = 3,010 and 2,979 , respectively ) .
RESULTS	Per-protocol VE was 16.1 % ( 95 % CI : -1.1 % , 30.4 % ; one-sided p = 0.032 ) against clinically confirmed AOM , 67.1 % ( 95 % CI : 17.0 % , 86.9 % ) against vaccine serotype clinically confirmed AOM , 100 % ( 95 % CI : 74.3 % , 100 % ) against vaccine serotype IPD , and 65.0 % ( 95 % CI : 11.1 % , 86.2 % ) against any IPD .
RESULTS	Results were consistent between intent-to-treat and per-protocol analyses .
RESULTS	Serious adverse events were reported for 21.5 % ( 95 % CI : 20.7 % , 22.2 % ) and 22.6 % ( 95 % CI : 21.9 % , 23.4 % ) of PHiD-CV and control recipients , respectively .
RESULTS	There were 19 deaths ( n = 11,798 ; 0.16 % ) in the PHiD-CV group and 26 deaths ( n = 11,799 ; 0.22 % ) in the control group .
RESULTS	A significant study limitation was the lower than expected number of captured AOM cases .
CONCLUSIONS	Efficacy was demonstrated against a broad range of pneumococcal diseases commonly encountered in young children in clinical practice .
BACKGROUND	www.ClinicalTrials.gov NCT00466947 .

###24373251
BACKGROUND	Optimization of chemotherapy effectiveness in metastatic colorectal cancers ( mCRC ) is a major endpoint to enhance the possibility of curative intent surgery .
BACKGROUND	FOLFIRI3 has shown promising results as second-line chemotherapy for mCRC patients previously exposed to oxaliplatin .
BACKGROUND	The clinical efficacy of FOLFIRI3 was never determined in association with bevacizumab in non-previously treated mCRC patients .
METHODS	We conducted a phase II clinical trial to characterize the response rate and toxicity profile of FOLFIRI3-bevacizumab as initial treatment for mCRC .
METHODS	Sixty-one patients enrolled in 3 investigation centers were treated with FOLFIRI3-bevacizumab ( median of 10cycles ) followed by a maintenance therapy combining bevacizumab and capecitabine .
METHODS	Levels of plasma angiopoietin-2 ( Ang-2 ) were measured by enzyme-linked immunosorbent assay at baseline .
RESULTS	Overall response rate ( ORR ) was 66.7 % ( 8 % of complete and 58 % of partial responses ) .
RESULTS	The disease control rate was 91.7 % .
RESULTS	After a median time of follow-up of 46.7 months , 56 patients ( 92 % ) had progressed or died .
RESULTS	The median progression free survival ( PFS ) was 12.7 months ( 95 % confidence interval ( CI ) 9.7-15 .8 months ) .
RESULTS	The median overall survival ( OS ) was 24.5 months ( 95 % CI : 10.6-38 .3 months ) .
RESULTS	Twenty-one patients underwent curative intent-surgery including 4 patients with disease initially classified as unresectable .
RESULTS	Most common grade III-IV toxicities were diarrhea ( 15 % ) , neutropenia ( 13 % ) , asthenia ( 10 % ) , and infections ( 4 % ) .
RESULTS	Hypertension-related medications needed to be increased in 3 patients .
RESULTS	In multivariate analysis , surgery of metastases and Ang-2 levels were the only independent prognostic factors for PFS and OS .
RESULTS	Indeed , baseline level of Ang-2 above 5ng/mL was confirmed as an independent prognostic factor for progression free survival ( HR = 0.357 ; 95 % CI : 0.168-0 .76 , p = 0.005 ) and overall survival ( HR = 0.226 ; 95 % CI : 0.098-0 .53 , p = 0.0002 ) .
CONCLUSIONS	As front-line therapy , FOLFIRI-3-bevacizumab is associated with an acceptable toxicity and induced promising objective response rates .
CONCLUSIONS	However , unfavorable clinical outcomes were observed in patients with high levels of angiopoietin-2 .

###25515106
OBJECTIVE	Despite considerable evidence supporting cognitive behavioral therapy for insomnia ( CBT-I ) for chronic insomnia , it remains untested within the context of acute insomnia .
OBJECTIVE	This study examined the efficacy of a single session of CBT-I , with an accompanying self-help pamphlet , for individuals with acute insomnia .
METHODS	A pragmatic parallel group randomized controlled trial .
METHODS	Community .
METHODS	Forty adults ( mean age 32.9 13.72 y ) with Diagnostic and Statistical Manual of Mental Disorders , Fifth Edition ( DSM-5 ) defined insomnia disorder , except a self-reported duration of less than 3 mo ( i.e. , acute insomnia ) , who reported no previous exposure to CBT-I and were not currently taking medication for sleep .
METHODS	A single 60 - to 70-min session of CBT-I ( n = 20 ) , with an accompanying self-help pamphlet , or wait list control group ( n = 20 ) .
METHODS	All subjects were offered a full individual course of CBT-I on completion of the study , regardless of group allocation .
RESULTS	Subjects completed sleep diaries and the Insomnia Severity Index ( ISI ) pretreatment and 1 mo following treatment .
RESULTS	There were no between-group differences on baseline ISI scores or subjective sleep continuity .
RESULTS	The intervention group reported significantly lower ISI scores than controls ( t ( 38 ) 2.24 , P < 0.05 ) at follow-up .
RESULTS	Further , using proposed ISI scores for identifying insomnia caseness ( i.e. , 10 ) , 60 % of those in the CBT-I group had remitted by 1 mo compared to 15 % of those in the control group .
CONCLUSIONS	This single session of cognitive behavioral therapy for insomnia ( CBT-I ) is sufficiently efficacious for a significant proportion of those with acute insomnia .
CONCLUSIONS	The results are discussed in terms of integrating this brief form of CBT-I into the `` stepped care '' model of insomnia .
BACKGROUND	Testing the efficacy of an early intervention for acute insomnia ( SRCTN05891695 ) http://www.controlled-trials.com/ISRCTN05891695 .

###25052227
OBJECTIVE	Dietary triacylglycerols containing palmitic acid in the sn-2 position might impair insulin release and increase plasma glucose .
METHODS	We used a cross-over designed feeding trial in 53 healthy Asian men and women ( 20-50 years ) to test this hypothesis by exchanging 20 % energy of palm olein ( PO ; control ) with randomly interesterified PO ( IPO ) or high oleic acid sunflower oil ( HOS ) .
METHODS	After a 2-week run-in period on PO , participants were fed PO , IPO and HOS for 6 week consecutively in randomly allocated sequences .
METHODS	Fasting ( midpoint and endpoint ) and postprandial blood at the endpoint following a test meal ( 3.54 MJ , 14g protein , 85g carbohydrate and 50g fat as PO ) were collected for the measurement of C-peptide , insulin , glucose , plasma glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 , lipids and apolipoproteins ; pre-specified primary and secondary outcomes were postprandial changes in C-peptide and plasma glucose .
RESULTS	Low density lipoprotein cholesterol was 0.3 mmol/l ( 95 % confidence interval ( 95 % CI ) ) 0.1 , 0.5 ; P < 0.001 ) lower on HOS than on PO or IPO as predicted , indicating good compliance to the dietary intervention .
RESULTS	There were no significant differences ( P = 0.58 ) between diets among the 10 male and 31 female completers in the incremental area under the curve ( 0-2h ) for C-peptide in nmol .120 min/l : GM ( 95 % CI ) were PO 220 ( 196 , 245 ) , IPO 212 ( 190 , 235 ) and HOS 224 ( 204 , 244 ) .
RESULTS	Plasma glucose was 8 % lower at 2h on IPO vs PO and HOS ( both P < 0.05 ) .
CONCLUSIONS	Palmitic acid in the sn-2 position does not adversely impair insulin secretion and glucose homeostasis .

###25234648
OBJECTIVE	Morquio A syndrome ( mucopolysaccharidosis IVA ; MPS IVA ) is a lysosomal storage disorder caused by deficiency of N-acetylgalactosamine-6-sulfatase , an enzyme required for degradation of the glycosaminoglycan keratan sulfate .
OBJECTIVE	Enzyme replacement therapy with elosulfase alfa provides a potential therapy for Morquio A syndrome .
OBJECTIVE	We analyzed the pharmacokinetics and pharmacodynamics of elosulfase alfa in Morquio A patients from a phase III clinical trial .
METHODS	In a randomized double-blind study , elosulfase alfa at 2.0 mg/kg was administrated weekly or every other week for 24 weeks .
METHODS	Pharmacokinetic parameters of elosulfase alfa were determined at weeks 0 and 22 by non-compartmental analysis .
METHODS	Safety was assessed throughout the study .
METHODS	The relationship of pharmacokinetic parameters to patient demographics , pharmacodynamic assessments , immunogenicity , and efficacy and safety outcomes were assessed graphically by treatment group .
RESULTS	Elosulfase alfa exposure and half-life ( t ( ) ) increased for both dose regimens during the study .
RESULTS	There appeared to be no consistent trend between drug clearance ( CL ) and patient 's sex , race , body weight , or age .
RESULTS	All patients developed anti-drug antibodies , but no association was noted between total antibody titer and CL .
RESULTS	In contrast , positive neutralizing antibody ( NAb ) status appeared to associate with decreased CL and prolonged t ( ) for patients in the cohort dosed weekly .
RESULTS	NAb may interfere with receptor-mediated cellular uptake and lead to increased circulation time of elosulfase alfa .
CONCLUSIONS	Despite the association between NAb and decreased drug clearance , neither dosing cohort showed associations between drug exposure and change in urinary keratan sulfate , 6-min walk test distances , or the occurrence of adverse events .

###24462034
BACKGROUND	Benign paroxysmal positional vertigo ( BPPV ) is a common presenting problem .
OBJECTIVE	Our aim was to compare the efficacy of vestibular rehabilitation ( maneuver ) vs. conventional therapy ( medications ) in patients presenting to the emergency department ( ED ) with BPPV .
METHODS	This was a prospective , single-blinded physician , randomized pilot study comparing two groups of patients who presented to the ED with a diagnosis of BPPV at a Level 1 trauma center with an annual census of approximately 75,000 .
METHODS	The first group received standard medications and the second group received a canalith repositioning maneuver .
METHODS	The Dizziness Handicap Inventory was used to measure symptom resolution .
RESULTS	Twenty-six patients were randomized ; 11 to the standard treatment arm and 15 to the interventional arm .
RESULTS	Mean age standard deviation of subjects randomized to receive maneuver and medication were 59 12.6 years and 64 11.2 years , respectively .
RESULTS	There was no significant difference in mean ages between the two treatment arms ( p = 0.310 ) .
RESULTS	Two hours after treatment , the symptoms between the groups showed no difference in measures of nausea ( p = 0.548 ) or dizziness ( p = 0.659 ) .
RESULTS	Both groups reported a high level of satisfaction , measured on a 0-10 scale .
RESULTS	Satisfaction in subjects randomized to receive maneuver and medication was 9 1.5 and 9 1.0 , respectively ; there was no significant difference in satisfaction between the two arms ( p = 0.889 ) .
RESULTS	Length of stay during the ED visit did not differ between the treatment groups ( p = 0.873 ) .
RESULTS	None of the patients returned to an ED for similar symptoms .
CONCLUSIONS	This pilot study shows promise , and would suggest that there is no difference in symptomatic resolution , ED length of stay , or patient satisfaction between standard medical care and canalith repositioning maneuver .
CONCLUSIONS	Physicians should consider the canalith repositioning maneuver as a treatment option .

###24874315
OBJECTIVE	To study the therapeutic efficacy and safety of Ginkgo special extract EGb 761 in the treatment of cognitive and non-cognitive symptoms ( anxiety , depression , sleep disorders , activity ) in patients with discirculatory encephalopathy ( DE ) and cognitive impairment .
METHODS	The study enrolled 45 patients with DE ( mean age 60,85,9 years ) .
METHODS	Patients were randomized to treatment with EGb 761 ( 30 patients ) or other drugs ( 15 patients ) .
METHODS	Patients underwent neurological examinations , along with cognitive and neuropsychological testing ( FAB , MMSE , HADS and other tests ) .
METHODS	EGb 761 was used in dose 240 mg per day during 24 weeks .
RESULTS	By the end of the study , the levels of anxiety and depression decreased ( p < 0,05 ) to the 12th and 24th week , respectively .
CONCLUSIONS	The results indicate the efficacy and good tolerability of EGb 761 in the treatment of mental disorders in DE patients with cognitive impairment .
CONCLUSIONS	The best effect was observed in relation to anxiety .

###25237048
BACKGROUND	This prospective , randomized , controlled clinical trial compared changes in primary outcome measures of claudication onset time ( COT ) and peak walking time ( PWT ) , and secondary outcomes of submaximal exercise performance , daily ambulatory activity , vascular function , inflammation , and calf muscle hemoglobin oxygen saturation ( StO2 ) in patients with symptomatic peripheral artery disease ( PAD ) following new exercise training using a step watch ( NEXT Step ) home-exercise program , a supervised exercise program , and an attention-control group .
RESULTS	One hundred eighty patients were randomized .
RESULTS	The NEXT Step program and the supervised exercise program consisted of intermittent walking to mild-to-moderate claudication pain for 12 weeks , whereas the controls performed light resistance training .
RESULTS	Change scores for COT ( P < 0.001 ) , PWT ( P < 0.001 ) , 6-minute walk distance ( P = 0.028 ) , daily average cadence ( P = 0.011 ) , time to minimum calf muscle StO2 during exercise ( P = 0.025 ) , large-artery elasticity index ( LAEI ) ( P = 0.012 ) , and high-sensitivity C-reactive protein ( hsCRP ) ( P = 0.041 ) were significantly different among the 3 groups .
RESULTS	Both the NEXT Step home program and the supervised exercise program demonstrated a significant increase from baseline in COT , PWT , 6-minute walk distance , daily average cadence , and time to minimum calf StO2 .
RESULTS	Only the NEXT Step home group had improvements from baseline in LAEI , and hsCRP ( P < 0.05 ) .
CONCLUSIONS	NEXT Step home exercise utilizing minimal staff supervision has low attrition , high adherence , and is efficacious in improving COT and PWT , as well as secondary outcomes of submaximal exercise performance , daily ambulatory activity , vascular function , inflammation , and calf muscle StO2 in symptomatic patients with PAD .
BACKGROUND	ClinicalTrials.gov .
BACKGROUND	Unique Identifier : NCT00618670 .

###26275735
BACKGROUND	One of the standard options in the treatment of stage IIIA/N2 non-small-cell lung cancer is neoadjuvant chemotherapy and surgery .
BACKGROUND	We did a randomised trial to investigate whether the addition of neoadjuvant radiotherapy improves outcomes .
METHODS	We enrolled patients in 23 centres in Switzerland , Germany and Serbia .
METHODS	Eligible patients had pathologically proven , stage IIIA/N2 non-small-cell lung cancer and were randomly assigned to treatment groups in a 1:1 ratio .
METHODS	Those in the chemoradiotherapy group received three cycles of neoadjuvant chemotherapy ( 100 mg/m ( 2 ) cisplatin and 85 mg/m ( 2 ) docetaxel ) followed by radiotherapy with 44 Gy in 22 fractions over 3 weeks , and those in the control group received neoadjuvant chemotherapy alone .
METHODS	All patients were scheduled to undergo surgery .
METHODS	Randomisation was stratified by centre , mediastinal bulk ( less than 5 cm vs 5 cm or more ) , and weight loss ( 5 % or more vs less than 5 % in the previous 6 months ) .
METHODS	The primary endpoint was event-free survival .
METHODS	Analyses were done by intention to treat .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00030771 .
RESULTS	From 2001 to 2012 , 232 patients were enrolled , of whom 117 were allocated to the chemoradiotherapy group and 115 to the chemotherapy group .
RESULTS	Median event-free survival was similar in the two groups at 128 months ( 95 % CI 97-229 ) in the chemoradiotherapy group and 116 months ( 84-152 ) in the chemotherapy group ( p = 067 ) .
RESULTS	Median overall survival was 371 months ( 95 % CI 226-500 ) with radiotherapy , compared with 262 months ( 199-521 ) in the control group .
RESULTS	Chemotherapy-related toxic effects were reported in most patients , but 91 % of patients completed three cycles of chemotherapy .
RESULTS	Radiotherapy-induced grade 3 dysphagia was seen in seven ( 7 % ) patients .
RESULTS	Three patients died in the control group within 30 days after surgery .
CONCLUSIONS	Radiotherapy did not add any benefit to induction chemotherapy followed by surgery .
CONCLUSIONS	We suggest that one definitive local treatment modality combined with neoadjuvant chemotherapy is adequate to treat resectable stage IIIA/N2 non-small-cell lung cancer .
BACKGROUND	Swiss State Secretariat for Education , Research and Innovation ( SERI ) , Swiss Cancer League , and Sanofi .

###25618967
OBJECTIVE	To observe the therapeutic effect of Chishaodanpi decoction ( CSDPD ) on chronic viral cholestatic hepatitis .
METHODS	A total of 107 subjects with chronic viral cholestatic hepatitis were enrolled in our hospital from March 2007 to November 2012 .
METHODS	Patients were randomly divided into treatment ( 54 cases ) and control groups ( 53 cases ) .
METHODS	The control group was treated with potassium magnesium aspartate , diammonium glycyrrhizinate , glucurolactone , vitamin C , and lamivudine , once a day .
METHODS	The treatment group was treated with modified CSDPD , 100 mL a time , twice a day , in addition to the treatment given to the control group .
METHODS	The patients in both groups were treated for 8 weeks .
METHODS	The main symptoms and signs were recorded every day throughout the clinical trial .
METHODS	Before and after the trial , changes in liver function including total bilirubin ( TBil ) , direct bilirubin ( DBil ) , total bile acid ( TBA ) , and the activities of alkaline phosphatase ( ALP ) , alanine aminotransferase ( ALT ) , aspartate aminotransferase ( AST ) , and - glutamyl transferase ( - GT ) , were all detected .
METHODS	Adverse reactions were also recorded .
RESULTS	There were no differences in gender , age , disease duration , symptoms , signs , or laboratory findings between the two groups ( P > 0.05 ) .
RESULTS	After an 8-week treatment , improvements in jaundice , weakness , poor appetite , abdominal distention , and skin itching were significantly better in the treatment group than in the control group ( P < 0.05 ) .
RESULTS	In the treatment group , 43 patients had a significant response to the treatment , seven patients had a response , and four patients had no response , with 21 , 12 , and 20 patients in the control group , respectively .
RESULTS	The total effective rate was 92.6 % in the treatment group and 62.3 % in the control group , which was a significant difference ( P < 0.05 ) .
RESULTS	The levels of TBil , DBil , TBA , ALP , ALT , AST , and - GT in both groups were significantly lower after treatment , and were significantly different between the two groups ( P < 0.05 ) .
RESULTS	A few patients in the treatment group had mild adverse effects such as increased bowel movement frequency and mild stomach-ache .
RESULTS	No other adverse reactions were observed in either group .

###24887018
OBJECTIVE	Increasing evidence suggests a relationship between poor sleep and the risk of developing Alzheimer disease .
OBJECTIVE	A previous study found an effect of sleep on - amyloid ( A ) , which is a key protein in Alzheimer disease pathology .
OBJECTIVE	To determine the effect of 1 night of total sleep deprivation on cerebrospinal fluid A42 protein levels in healthy middle-aged men .
METHODS	The Alzheimer , Wakefulness , and Amyloid Kinetics ( AWAKE ) study at the Radboud Alzheimer Center , a randomized clinical trial that took place between June 1 , 2012 , and October 1 , 2012 .
METHODS	Participants were cognitively normal middle-aged men ( 40-60 years of age ) with normal sleep ( n = 26 ) recruited from the local population .
METHODS	Participants were randomized to 1 night with unrestricted sleep ( n = 13 ) or 1 night of total sleep deprivation ( 24 hours of wakefulness ) ( n = 13 ) .
METHODS	Sleep was monitored using continuous polysomnographic recording from 3 pm until 10 am .
METHODS	Cerebrospinal fluid samples were collected using an intrathecal catheter at defined times to compare cerebral A42 concentrations between evening and morning .
RESULTS	A night of unrestricted sleep led to a 6 % decrease in A42 levels of 25.3 pg/mL ( 95 % CI [ 0.94 , 49.6 ] , P = .04 ) , whereas sleep deprivation counteracted this decrease .
RESULTS	When accounting for the individual trajectories of A42 over time , a difference of 75.8 pg/mL of A42 was shown between the unrestricted sleep and sleep deprivation group ( 95 % CI [ 3.4 , 148.4 ] , P = .04 ) .
RESULTS	The individual trajectories of evening and morning A42 concentrations differed between the unrestricted sleep and sleep deprivation groups ( P = .04 ) in contrast to stable A40 , tau , and total protein levels .
CONCLUSIONS	Sleep deprivation , or prolonged wakefulness , interferes with a physiological morning decrease in A42 .
CONCLUSIONS	We hypothesize that chronic sleep deprivation increases cerebral A42 levels , which elevates the risk of Alzheimer disease .
BACKGROUND	clinicaltrials.gov Identifier : NCT01194713 .

###26255546
OBJECTIVE	This 12-week randomized placebo controlled clinical trial investigated the effect of Coenzyme Q10 ( CoQ10 ) on diabetic neuropathy , oxidative stress , blood glucose and lipid profile of patients with type 2 diabetes .
METHODS	Diabetic patients with neuropathic signs ( n = 70 ) were randomly assigned to CoQ10 ( 200 mg/d ) or placebo for 12 weeks .
METHODS	Blood samples were collected for biochemical analysis and neuropathy tests before and after the trial .
RESULTS	There were no significant differences between the two groups in terms of mean fasting blood glucose , HbA1c and the lipid profile after the trial .
RESULTS	The mean insulin sensitivity and total antioxidant capacity ( TAC ) concentration significantly increased in the Q10 group compared to the placebo after the trial ( P < 0.05 ) .
RESULTS	C-reactive protein ( hsCRP ) significantly decreased in the intervention group compared to placebo after the trial ( P < 0.05 ) .
RESULTS	In the control group , insulin sensitivity decreased and HOMA-IR increased , which revealed a significant difference between groups after the trial .
RESULTS	Neuropathic symptoms and electromyography measurements did not differ between two groups after the trial .
CONCLUSIONS	According to the present study , CoQ10 , when given at a dose of 200 mg/d for 12 weeks to a group of neuropathic diabetic patients , did not improve the neuropathy signs compared to placebo , although it had some beneficial effects on TAC and hsCRP and probably a protective effect on insulin resistance .

###25516196
OBJECTIVE	Pneumonia is a major cause of mortality and morbidity in patients with stroke fed via nasogastric tubes and may be because of vomiting and gastro-oesophageal regurgitation .
OBJECTIVE	The aim of the study was to assess whether regular treatment with metoclopramide , a D2-receptor antagonist with antiemetic and gastric prokinetic actions , could reduce the rate of aspiration and pneumonia .
METHODS	Patients with no signs of pneumonia within 7 days of stroke onset and 48 hours of insertion of a nasogastric tube were recruited into a double-blind randomized placebo-controlled trial .
METHODS	Participants received metoclopramide 10 mg or placebo 3 daily via the nasogastric tube for 21 days or until nasogastric feeds were discontinued .
METHODS	Clinical signs of pneumonia were recorded daily .
METHODS	Pneumonia was diagnosed if the patient had relevant clinical signs , high inflammatory markers , and new infiltrates on the chest radiograph .
RESULTS	Sixty patients ( mean age , 78 years ; 38 women ; mean National Institutes for Health Stroke Scale score , 19.25 ) were randomized in a 1:1 ratio .
RESULTS	There were significantly more episodes of pneumonia in the placebo group than in the metoclopramide group ( rate ratio , 5.24 ; P < 0.001 ) .
RESULTS	There were also significant differences in favor of metoclopramide in the rate of aspiration , oxygen saturation , highest inflammatory markers , and National Institutes for Health Stroke Scale .
RESULTS	There was no significant difference in mortality between the groups .
CONCLUSIONS	This study suggests that metoclopramide may reduce the rate of pneumonia and may improve other clinical outcomes in patients with subacute stroke fed via nasogastric tube .
CONCLUSIONS	These findings need to be confirmed in larger randomized and blinded trials .
BACKGROUND	https://www.clinicaltrialsregister.eu .
BACKGROUND	EudraCT no : 2006-002570-22 , URL : http://www.controlled-trials.com/ISRCTN18034911/18034911 .

###25752115
OBJECTIVE	To analyze the correlation of the tympanic injection of triamcinolone acetonide , middle ear pressure ( MEP ) and radioactive secretory otitis media ( RSOM ) with nasopharyngeal carcinoma ( NPC ) after radiotherapy .
METHODS	Fifty-two patients suffering NPC without otitis media before radiotherapy were randomly divided into three groups .
METHODS	17 cases with 34 ears were distributed into treatment group I , and radiotherapy 1 hour before the start of each side of the tympanic cavity injection of triamcinolone acetonide injection , 1-7 weeks 1 times a week .
METHODS	Treatment group I had 17 cases with 34 ears , and radiotherapy 1 hour before the start of each side of the tympanic cavity injection of triamcinolone acetonide injection , 1-12 weeks 1 times a week .
METHODS	And control group consisted of 18 cases with 36 ears who did n't accept such treatment .
METHODS	In all 104 ears , MEP was tested at the begin of radiotherapy and the end of 1st , 2nd , 3rd month after radiotherapy .
RESULTS	From the beginning of radiotherapy to the end of th 1st , 2nd , 3rd month after radiotherapy , the morbidity of RSOM gradually increased and MEP decreased in the treatment group I , II and the control group , in which treatment group II showed the lowest morbidity of RSOM and MEP was maximum ( P < 0.01 ) , and the treatment group I showed the lower morbidity of RSOM and MEP was greater ( P < 0.05 ) , while the control group showed the highest morbidity of RSOM and MEP was minimum ( P > 0.05 ) .
CONCLUSIONS	Tympanic injection of triamcinolone acetonide could reduce radiation injury , and medication time was positively correlated with the MEP , and a negative correlation with RSOM morbidity , and the longer treatment , the more significant the effect is .
CONCLUSIONS	The difference is most obvious at the end of 3rd month after radiotherapy .
CONCLUSIONS	It may be due to the more active repairation after radiation damage in middle ears , but long-term efficacy must continue to observe .

###25252624
BACKGROUND	The development of osteoarthritis ( OA ) involves inflammation , but the evidence for participation of genes propagating or inhibiting inflammation in the OA process is inconsistent .
BACKGROUND	We investigated the associations of common variants in the TNF gene , and their interactions with other cytokine genes , with hand OA among Finnish women .
METHODS	This cross-sectional study was based on bilateral hand radiographs of 542 female dentists and teachers which were classified according to the presence of OA ( radiographic K-L score 2 in 3 joints ) using reference images .
METHODS	The genotypes were determined by PCR-based methods .
METHODS	The degree of pairwise linkage disequilibrium ( LD ) and haplotypes were constructed and analyzed by the SNPStats software .
METHODS	The associations between four TNF SNPs and hand OA were tested using logistic regression adjusting for age , occupation , and BMI , and fitting a log-additive model of inheritance .
METHODS	Gene-gene interactions of TNF SNPs with IL4R and IL10 SNPs were examined by stratified logistic regression analyses .
METHODS	Possible interactions of the TNF SNPs with variants in the previously reported IL1 and IL6 genes in influencing hand OA were also explored .
RESULTS	Two TNF polymorphisms ( '' -1031 '' and '' -863 '' ) were associated with hand OA ( OR = 1.45 , 95 % CI 1.01-2 .07 and 1.55 , 1.06-2 .25 , respectively ) .
RESULTS	These associations retained when adjusting further for IL1 `` 3954 '' and IL6 `` 174 '' .
RESULTS	The TNF G-A-G haplotype was associated with an increased risk of hand OA ( 1.61 , 1.10-2 .37 , p = 0.01 ) .
RESULTS	Interactions were observed between TNF '' -1031 '' and IL4R Ser503Pro , TNF '' -1031 '' and IL10 '' -1082 '' , and TNF '' -863 '' and IL10 '' -1082 '' SNPs with regard to hand OA ( p = 0.012 , p = 0.0068 , and p = 0.02 , respectively ) .
RESULTS	The carriage of the TNF '' -1031 '' minor allele doubled the risk ( 2.01 , 1.26 - 3.22 ) only in women with the IL4R Ser/Ser genotype .
RESULTS	Similarly , the TNF '' -1031 '' and '' -863 '' minor alleles were associated with an increased risk of hand OA only in IL10 G/G or A/A homozygotes ( 2.54 , 1.45-4 .47 and 2.60 , 1.46-4 .62 , respectively ) but not in heterozygotes ( G/A ) .
CONCLUSIONS	Our results suggest that the TNF gene variants play a role in the etiology of hand OA .
CONCLUSIONS	In addition , the findings are suggestive of a gene-gene interaction of the TNF with IL4R and IL10 genes .

###25012990
OBJECTIVE	The aim of this study is to explore whether administration timing affects glycaemic control by lixisenatide once-daily in type 2 diabetes mellitus ( T2DM ) .
METHODS	A phase IIIb , open-label , 1:1 randomized , active-controlled , 24-week multicentre study of T2DM patients inadequately controlled on metformin was conducted .
METHODS	Patients were administered lixisenatide before breakfast or the main meal .
METHODS	The primary endpoint was change from baseline at week 24 in glycated haemoglobin ( HbA1c ) .
METHODS	Other endpoints : changes in body weight , fasting plasma glucose ( FPG ) , 7-point self-monitored plasma glucose ( SMPG ) and Diabetes Treatment Satisfaction Questionnaire status ( DTSQs ) score .
METHODS	Adverse events ( AEs ) were monitored .
RESULTS	Mean change in HbA1c from baseline at week 24 was -0.65 % ( -7.1 mmol/mol ; main meal ) and -0.74 % ( -8.1 mmol/mol ; breakfast ) .
RESULTS	Mean changes in FPG , body weight and DTSQs score were comparable between groups .
RESULTS	The mean change in body weight ( kg ) was -2.60 ( main meal ) and -2.80 ( breakfast group ) .
RESULTS	The 7-point SMPG profiles showed greatest reductions in postprandial glucose after the meal at which lixisenatide was administered , with a residual effect seen on the subsequent meal .
RESULTS	AE rates were similar between groups , including gastrointestinal AEs .
CONCLUSIONS	Lixisenatide before the main meal was noninferior to lixisenatide before breakfast in patients insufficiently controlled on metformin .
CONCLUSIONS	Lixisenatide treatment allows flexibility in administration timing .

###25918644
BACKGROUND	Weight lost by obese patients is almost always regained over time .
BACKGROUND	Extended treatment may improve maintenance , but solid evidence is lacking .
OBJECTIVE	We determined effectiveness of maintenance therapy after a weight loss program .
METHODS	Together 201 patients ( mean age 47 years and BMI 42kg/m ( 2 ) , 71 % women ) were randomly assigned to either a 17-week weight loss program followed by a one-year maintenance program or to a weight loss program without subsequent maintenance intervention .
METHODS	The weight loss program included behavior modification and a very-low-calorie diet , and maintenance program behavior modification .
METHODS	The primary outcome measure was percentage of patients with 5 % or more weight loss at the end of maintenance ( week 69 ) and one year later ( week 121 ) .
METHODS	Secondary outcomes were weight related changes in lifestyle and quality of life .
RESULTS	At week 69 , 52 % of the patients with and 44 % of those without maintenance program had lost weight 5 % , P = 0.40 , and , at week 121 , 33 % and 34 % , P = 0.77 , respectively .
RESULTS	At week 121 secondary outcomes did not differ between the groups among those successfully followed up .
CONCLUSIONS	This one-year maintenance program was not effective in preventing weight regain in severely obese patients .
CONCLUSIONS	Trial Registration .
CONCLUSIONS	This trial is registered under clinicaltrials.gov Identifier : NCT00590655 .

###24320801
OBJECTIVE	This study aims to investigate the effects of low-level laser therapy ( LLLT ) on biceps brachi muscular fatigue in 20 young females .
BACKGROUND	Exhausting physical activity leads to muscular fatigue , which could decrease muscular strength , and may cause impairment in motor control and muscle pain .
BACKGROUND	Several biochemical and biophysical resources have been studied in an attempt to accelerate the recovery of muscle fatigue .
BACKGROUND	Among these , LLLT is emphasized .
METHODS	Twenty subjects were randomized in one laser group and one placebo group in two sessions of a crossover design experimental procedure ; the second session taking place within 7 days of the first .
METHODS	In the first session , subjects underwent a collection of surface electromyographic ( SEMG ) data of the biceps brachii muscle , followed by active or placebo LLLT at the same muscle , followed then by another EMG sample of biceps brachii .
METHODS	Blood samples were collected five times during the experimental procedure .
METHODS	Second session procedures were identical to the first , with exception of LLLT , which was the opposite of the first session .
METHODS	The fatigue protocol consisted of 60 sec of elbow flexion-extension movement performed with 75 % of one maximum repetition .
METHODS	Blood lactate , EMG fatigue , and the number of elbow flexion-extension repetitions during the fatigue protocol were used to evaluate the effects of laser therapy ( 808 nm wavelength , 100 mW output power , power density of 35.7 W/cm ( 2 ) , 70 sec each point and 7 J/point on eight points ) .
RESULTS	No statistical differences were found for eletromyographic fatigue and blood lactate values between groups .
RESULTS	Mean numbers of elbow flexion-extension repetitions were 22.6 7.58 after placebo , and 25.1 9.89 after active LLLT group , but these differences were not statistically significant ( p = 0.342 ) .
CONCLUSIONS	LLLT had limited effects on delaying muscle fatigue in a young female sample , although a tendency was observed in the active laser group toward showing lower electromyography fatigue of biceps brachii muscle .
CONCLUSIONS	No intergroup differences were found in the number of muscle contractions and lactate concentration .

###26026485
BACKGROUND	To determine the optimal single-dose radiotherapy schedule for pain from bone metastases in a multi-centre , international , randomised trial .
METHODS	651 patients were randomised to either 8Gy ( n = 325 ) or 4Gy ( n = 326 ) radiotherapy .
METHODS	Pain at 4 , 8 , 12 , 24 and 52weeks was assessed using a Categorical Scale ( CS ) and a Visual Analogue Scale ( VAS ) .
METHODS	The primary endpoint was response at 4weeks .
RESULTS	There was no significant difference in patient demographics and other co-variates .
RESULTS	The complete response ( CR ) rate and ORR ( complete or partial response ) for all follow-up times were higher after 8Gy ( p = 0.02 ) .
RESULTS	The Kaplan-Meier actuarial rate ( categorical scale ) at 4weeks for ORR was 80 % after 8Gy compared to 68 % after 4Gy ( p = 0.0015 ) .
RESULTS	117 re-treatments were given of which 72 were in the 4Gy group and 45 in 8Gy arm ( p = 0.01 ) .
CONCLUSIONS	There was a marked consistent difference in pain relief at all time points in favour of 8Gy .
CONCLUSIONS	These data reinforce the case for single dose 8Gy radiotherapy to be recommended for metastatic bone pain in all healthcare settings .

###26456905
BACKGROUND	Chronic hepatitis C virus ( HCV ) infection in patients with stage 4-5 chronic kidney disease increases the risk of death and renal graft failure , yet patients with hepatitis C and chronic kidney disease have few treatment options .
BACKGROUND	This study assesses an all-oral , ribavirin-free regimen in patients with HCV genotype 1 infection and stage 4-5 chronic kidney disease .
METHODS	In this phase 3 randomised study of safety and observational study of efficacy , patients with HCV genotype 1 infection and chronic kidney disease ( stage 4-5 with or without haemodialysis dependence ) were randomly assigned to receive grazoprevir ( 100 mg , NS3/4A protease inhibitor ) and elbasvir ( 50 mg , NS5A inhibitor ; immediate treatment group ) or placebo ( deferred treatment group ) once daily for 12 weeks .
METHODS	Randomisation was done centrally with an interactive voice response system .
METHODS	An additional cohort of patients who were not randomised received the same regimen open-label and underwent intensive pharmacokinetic sampling .
METHODS	The primary efficacy outcome was a non-randomised comparison of sustained virological response at 12 weeks ( SVR12 ) after the end of therapy for the combined immediate treatment group and the pharmacokinetic population with a historical control .
METHODS	The primary safety outcome was a randomised comparison between the immediate treatment group and the deferred treatment group .
METHODS	After 4 weeks of follow-up ( study week 16 ) , unmasking occurred and patients in the deferred treatment group received grazoprevir and elbasvir .
METHODS	The primary efficacy hypothesis was tested at a two-sided significance level ( type I error ) of 005 using an exact test for a binomial proportion .
METHODS	Safety event rates were compared between immediate treatment and deferred treatment groups using the stratified Miettinen and Nurminen method with baseline dialysis status as the strata .
METHODS	The study is registered at ClinicalTrials.gov , number NCT02092350 .
RESULTS	224 patients were randomly assigned to the immediate treatment group with grazoprevir and elbasvir ( n = 111 ) or the deferred treatment group ( n = 113 ) , and 11 were assigned to the intensive pharmacokinetic population .
RESULTS	Overall , 179 ( 76 % ) were haemodialysis-dependent , 122 ( 52 % ) had HCV genotype 1a infection , 189 ( 80 % ) were HCV treatment-naive , 14 ( 6 % ) were cirrhotic , and 108 ( 46 % ) were African American .
RESULTS	Of the 122 patients receiving grazoprevir and elbasvir , six were excluded from the primary efficacy analysis for non-virological reasons ( death , lost-to-follow-up [ n = 2 ] , non-compliance , patient withdrawal , and withdrawal by physician for violent behaviour ) .
RESULTS	No patients in the combined immediate treatment group and intensive pharmacokinetic population and five ( 4 % ) in the deferred treatment group discontinued because of an adverse event .
RESULTS	Most common adverse events were headache , nausea , and fatigue , occurring at similar frequencies in patients receiving active and placebo drugs .
RESULTS	SVR12 in the combined immediate treatment group and intensive pharmacokinetic population was 99 % ( 95 % CI 953-1000 ; 115/116 ) , with one relapse 12 weeks after end of treatment when compared with a historical control of 45 % , based on meta-analyses of interferon-based regimens used in clinical trials of patients infected with HCV who are on haemodialysis .
CONCLUSIONS	Once-daily grazoprevir and elbasvir for 12 weeks had a low rate of adverse events and was effective in patients infected with HCV genotype 1 and stage 4-5 chronic kidney disease .
BACKGROUND	Merck Sharp & Dohme Corp. .

###25831700
OBJECTIVE	To evaluate the efficacy and safety of the novel oral anticoagulants under conservative hemostasis with tranexamic acid in hip arthroplasty .
METHODS	All patients received 40 mg of enoxaparin 12 hours prior to surgery and on the operating day , and then they received either 10 mg of rivaroxaban ( 40 patients ) , 220 mg of dabigatran ( 42 patients ) or 40 mng of enoxaparin ( 39 patients ) .
METHODS	Tranexamic acid with doses of 10 - 20 mg/kg was administered to all patients : within 30 minutes prior to surgery and 6 hours after the first infision .
METHODS	The hemorrhagic and thrombotic complications in a hospital outpatient therapy and outcomes in 35 days after surgery were evaluated .
RESULTS	Minor bleeding was observed only in the rivaroxaban group , the complications rate in hospital was 2.5 % , among outpatients 3.1 % .
RESULTS	At hospital discharge the DVT was 12.5 % in rivaroxaban group , 7 % in dabigatran and 8 % in enoxaparin group ( p > 0.05 ) .
RESULTS	Asymptomatic distal DVT was found in 82 % of patients by ultrasound screening .
CONCLUSIONS	The new oral anticoagulants are effective and safe for venous thromboembolism preventing after hip re placement .
CONCLUSIONS	Routine use of tranexamic acid was not accompanied by increased risk of DVT

###24621348
OBJECTIVE	This article is based on our previously reported results of irregular bowel movement and disturbances of the intestinal microbiota/environment in gastrectomized patients .
OBJECTIVE	A placebo-controlled , double-blind comparative study was carried out to evaluate the effects of a fermented milk beverage containing Lactobacillus casei strain Shirota ( LcS ) in such patients .
OBJECTIVE	The major evaluated factors of this article were `` bowel movement '' and `` quality of life . ''
OBJECTIVE	The secondary evaluated factors were `` fecal microbiota '' and `` enteric environment . ''
METHODS	Of the 190 gastrectomized subjects who participated in our previously reported defecation survey , 134 subjects judged as having abnormal defecation gave consent to participate in this study .
METHODS	These subjects continuously ingested the test beverage containing 40 billion LcS or placebo ( one bottle per day , 4 weeks ) .
RESULTS	In the LcS-ingested group , among the 118 subjects who completed the tests , the assessments of the subjects were based on their division into groups based on their symptoms with our scoring system for constipation/diarrhea ; although there was no significant ingestion effect in total , in the constipation group , LcS reduced the degree of constipation compared with that in the placebo group .
RESULTS	In the diarrhea group , LcS ingestion improved diarrhea compared with that in the preingestion state .
RESULTS	Fecal Staphylococcus level was decreased .
CONCLUSIONS	The results suggest the possibility that the continuous consumption of LcS-fermented milk relieves irregular bowel movement in gastrectomized patients .

###24886681
BACKGROUND	We have assessed the utility of autologous mesenchymal stem cell ( MSC ) peripheral vein infusion as a possible therapeutic modality for patients with end-stage liver diseases .
METHODS	Forty patients with post-hepatitis C virus ( HCV ) end-stage liver disease were randomized into two groups : Group 1 ( GI ) : 20 patients who received granulocyte colony-stimulating factor ( G-CSF ) for 5days followed by autologous MSCs peripheral-vein infusion and group 2 ( GII ) : 20 patients who received regular liver-supportive treatment only ( control group ) .
RESULTS	In MSC-infused patients ( GI ) , 54 % showed near normalization of liver enzymes and improvement in liver synthetic function .
RESULTS	Significant changes were reported in albumin ( P = 0.000 ) , bilirubin ( P = 0.002 ) , increased international normalized ratio ( INR ) ( P = 0.017 ) , prothrombin concentration ( P = 0.029 ) and alanine transaminase ( ALT ) levels ( P = 0.029 ) , with stabilization of clinical and biochemical status in 13 % of cases .
RESULTS	None of the patients in GII showed any significant improvement .
RESULTS	Hepatic fibrosis was assessed in GI by detection of procollagen IIIC peptide level ( PIIICP ) and procollagen III N peptide level ( PIIINP ) .
RESULTS	The pretreatment values of s-PIIICP and s-PIIINP were 9.44.2 and 440189 , respectively , with a decrease to 8.12.6 and 388102 , respectively , 3months after MSC therapy .
RESULTS	However , the difference was statistically nonsignificant ( P = 0.7 ) .
RESULTS	A significant correlation coefficient was reported after 3months between the s-PIIINP and prothrombin concentration ( P = -0.5 ) and between s-PIIICP and ascites ( P = 0.550 ) .
CONCLUSIONS	First , autologous MSC infusion into a peripheral vein is as effective as the previously reported intrahepatic infusion .
CONCLUSIONS	Second , MSCs have a supportive role in the treatment of end-stage liver disease , with satisfactory tolerability and beneficial effects on liver synthetic functions and hepatic fibrosis .
CONCLUSIONS	Third , IV infusion of MSCs after G-CSF mobilization improves s-albumin within the first 2weeks and prothrombin concentration and alanine Taransaminase after 1month .
CONCLUSIONS	According to the data from this current study and those previously reported by our group , we recommend further studies on patients ' infusion with pure CD133 and CD34 followed by IV infusion of in vitro-differentiated MSCs within 1week and another infusion after 3months .
BACKGROUND	ClinicalTrials.gov NCT01729221 .
BACKGROUND	Registered 17 November 2012 .

###25271534
OBJECTIVE	Local application of mitomycin-c ( MMC ) seems to be effective in reducing adhesions and stenosis after FESS .
OBJECTIVE	However this is not clearly seen in frontal sinusotomy .
OBJECTIVE	This study assesses the effectiveness of local MMC in the frontal ostium using a foamy material ( otowick ) and compared with cottonoids .
METHODS	Forty-seven patients with chronic rhinosinusitis without polyps enrolled in this study .
METHODS	Two subgroups were studied : one with MMC application in one nostril using cottonoids and a second with MMC injected in an otowick .
METHODS	In all patients MMC was applied twice , intraoperatively and 4 weeks later .
METHODS	In both groups normal saline was applied to the other nostril on the same material with the MMC side .
METHODS	Six months postoperatively all patients were assessed endoscopically by a clinician blinded to the MMC side .
RESULTS	Overall , MMC application was more effective than normal saline in both groups .
RESULTS	Otowick use presented favorable initial results especially in primary cases regarding ostium patency , and need for revision surgery .
RESULTS	The use of MMC cottonoids did not show any benefit in primary cases .
CONCLUSIONS	The described technique seems to be effective in maintaining frontal ostium patency as it provides a more precise and deeper drug delivery to this area .

###24874285
BACKGROUND	This pilot study aimed to test the possibility of therapeutic benefit imparted by early intervention based on sequential tumour marker ( TM ) measurements during follow-up of primary breast cancer ( PBC ) patients .
METHODS	Patients with oestrogen receptor positive PBC with no clinical and/or radiological evidence of metastases were recruited and followed-up 3-monthly with clinical assessment and TM ( CA15 .3 and CEA ) measurements .
METHODS	The clinical team was blinded to the TM results .
METHODS	Asymptomatic patients who developed raised TMs ( based on pre-defined cut-offs ) were randomised to either ` treatment change ' ( either start or change of adjuvant endocrine agent to another agent ) or ` no change ' ( control ) .
METHODS	Patients who developed symptomatic metastases came off the study .
METHODS	The primary and secondary endpoints were intervals from randomisation to symptomatic metastases and to last follow-up/death respectively .
RESULTS	Eighty-five patients ( median age = 54 years ( 30-72 ) ) were recruited with a median follow-up of 81 months ( 1-124 ) .
RESULTS	Sixteen patients were randomised as described .
RESULTS	There was no significant difference ( treatment change versus no change ) with regards to interval from randomisation to symptomatic metastases - 23 ( 2-62 ) and 22 ( 1-63 ) months respectively ( p = 0.9 ) , as well as interval from randomisation to last follow-up/death - 36 ( 7-63 ) and 37 ( 10-63 ) months respectively ( p = 0.9 ) .
CONCLUSIONS	Despite long follow-up ( up to 10 + years ) , this small study has thus far shown no significant difference in outcome .
CONCLUSIONS	However , we have confirmed the feasibility of this study design but a larger study will be required to show if there is a benefit to this approach .

###25039675
OBJECTIVE	Progressive - cell dysfunction hinders the maintenance of glycaemic control in type 2 diabetes , but comparative data on - cell-protective therapies are lacking in the early stage of type 2 diabetes .
OBJECTIVE	Here we evaluated the comparative glycaemic efficacy and impact on - cell function of three antihyperglycaemic agents that have a - cell-protective effect , exenatide , insulin and pioglitazone , in newly diagnosed patients with type 2 diabetes .
METHODS	In this 48-week , multicentre , parallel-group study , 416 patients newly diagnosed with type 2 diabetes were randomly assigned 1 : 1 : 1 to receive exenatide , insulin or pioglitazone .
METHODS	The primary end-point was the change in glycosylated haemoglobin ( HbA1c ) from baseline .
METHODS	Secondary end-points included effects on weight , blood pressure , lipid profiles and - cell function assessed by homeostasis model assessment , fasting proinsulin : insulin ( PI/I ) , disposition index ( DI ) and acute insulin response ( AIR ) .
RESULTS	At week 48 , mean [ 95 % confidence interval ( CI ) ] HbA1c changes from baseline were -1.8 % ( -1.55 % to -2.05 % ) with exenatide , -1.7 % ( -1.52 % to -1.96 % ) with insulin and -1.5 % ( -1.23 % to -1.71 % ) with pioglitazone .
RESULTS	Treatment differences were -0.20 % ( 95 % CI -0.46 % to 0.06 % ) for exenatide versus insulin ( P = 0.185 ) , and -0.37 % ( 95 % CI -0.63 % to -0.12 % ) for exenatide versus pioglitazone ( P = 0.002 ) .
RESULTS	Significant improvements from baseline in AIR , PI/I and DI were observed with all treatments , with the greatest improvements in DI , as well as weight , blood pressure and lipid profile , observed with exenatide .
CONCLUSIONS	All three agents showed efficacy regarding glycaemic control and metabolic benefits ; however , exenatide showed the greatest efficacy .
CONCLUSIONS	- cell function improved in all treatment groups ; hence , early initiation of - cell-protective therapy may halt the decline in - cell function in type 2 diabetes .

###24703832
BACKGROUND	Evidence suggests that brief physiotherapy programmes are as effective for acute whiplash-associated disorders as more comprehensive programmes ; however , whether this also holds true for chronic whiplash-associated disorders is unknown .
BACKGROUND	We aimed to estimate the effectiveness of a comprehensive exercise programme delivered by physiotherapists compared with advice in people with a chronic whiplash-associated disorder .
METHODS	PROMISE is a two group , pragmatic randomised controlled trial in patients with chronic ( > 3 months and < 5 years ) grade 1 or 2 whiplash-associated disorder .
METHODS	Participants were randomly assigned by a computer-generated randomisation schedule to receive either the comprehensive exercise programme ( 20 sessions ) or advice ( one session and telephone support ) .
METHODS	Sealed opaque envelopes were used to conceal allocation .
METHODS	The primary outcome was pain intensity measured on a 0-10 scale .
METHODS	Outcomes were measured at baseline , 14 weeks , 6 months , and 12 months by a masked assessor .
METHODS	Analysis was by intention to treat , and treatment effects were calculated with linear mixed models .
METHODS	The trial is registered with the Australian New Zealand Clinical Trials Registry , number ACTRN12609000825257 .
RESULTS	172 participants were allocated to either the comprehensive exercise programme ( n = 86 ) or advice group ( n = 86 ) ; 157 ( 91 % ) were followed up at 14 weeks , 145 ( 84 % ) at 6 months , and 150 ( 87 % ) at 12 months .
RESULTS	A comprehensive exercise programme was not more effective than advice alone for pain reduction in the participants .
RESULTS	At 14 weeks the treatment effect on a 0-10 pain scale was 00 ( 95 % CI -07 to 07 ) , at 6 months 02 ( -05 to 10 ) , and at 12 months -01 ( -08 to 06 ) .
RESULTS	CNS hyperexcitability and symptoms of post-traumatic stress did not modify the effect of treatment .
RESULTS	We recorded no serious adverse events .
CONCLUSIONS	We have shown that simple advice is equally as effective as a more intense and comprehensive physiotherapy exercise programme .
CONCLUSIONS	The need to identify effective and affordable strategies to prevent and treat acute through to chronic whiplash associated disorders is an important health priority .
CONCLUSIONS	Future avenues of research might include improving understanding of the mechanisms responsible for persistent pain and disability , investigating the effectiveness and timing of drugs , and study of content and delivery of education and advice .
BACKGROUND	The National Health and Medical Research Council of Australia , Motor Accidents Authority of New South Wales , and Motor Accident Insurance Commission of Queensland .

###25575067
OBJECTIVE	To observe the changes in cardiac function , peripheral blood B and T lymphocyte attenuator ( BTLA ) and oxidative stress related indicators in rheumatoid arthritis ( RA ) patients , thus to explore the mechanism underlying the improving effect of Xinfeng Capsule ( XFC ) on cardiac function .
METHODS	The study enrolled 100 RA patients and divided them randomly into 2 groups , XFC treatment group and leflunomide ( LEF ) control group ( n = 50 per group ) .
METHODS	The treatment lasted 30 days for one course .
METHODS	Other 40 healthy people from Medical Examination Center were included as a normal control ( NC ) group .
METHODS	Flow cytometry was used to detect the expression and activation level of BTLA , Westergren method was used to determine erythrocyte sedimentation rate ( ESR ) , and automatic biochemical analyzer to examine high sensitivity C-reactive protein ( hs-CRP ) and rheumatoid factor ( RF ) .
METHODS	ELISA method was performed to observe related cytokines ( IL-1 , IL-17 , IL-35 , IFN - ) and markers of oxidative stress such as total antioxidant capacity ( TAOC ) , malondialdehyde ( MDA ) , reactive oxygen species ( ROS ) , superoxide dismutase ( SOD ) , glutathione ( GSH ) .
METHODS	Echocardiography was utilized to survey cardiac function parameters including heart ejection fraction ( EF % ) , stroke volume ( SV % ) , fractional shortening ( FS % ) , E peak velocities ( E ) and A peak velocities ( A ) of mitral valve flow , and the ratio of filling fraction of E and A ( E/A ) .
RESULTS	Compared with the NC group , EF % , E peak velocity , E/A were significantly reduced while A peak velocity increased in RA patients , and FS % was not found obviously different .
RESULTS	In addition , IL-1 , IL-17 and inflammatory indexes like ESR , CRP increased while BTLA , IL-35 , IFN - decreased significantly ; Serum ROS , MDA rose and SOD , GSH dropped significantly in RA patients .
RESULTS	Correlation analysis showed that the cardiac function parameters EF , FS were negatively correlated with CD24 cells and CD19CD24 cells , that E/A was positively correlated with BTLA , that A peak velocity was positively related to CD19 cells , that EF was positively related to ROS , that SV was positively related with MDA , SOD , that E peak velocity was negatively correlated with TAOC .
RESULTS	After drug intervention , XFC treatment group got 86 % total effective rate .
RESULTS	XFC obviously improved cardiac function regarding EF % , FS % , E peak , E/A and other parameters , increased serum SOD , GSH capacity , eliminated ROS , MDA , increased BTLA , IL-35 , IFN - , and reduced IL-1 , IL-17 .
RESULTS	Compared with LEF group , XFC had a better improving effect on DAS28 and cardiac function parameters .
CONCLUSIONS	XFC can increase BTLA expression of CD19 and CD24 B cells and reduce B cell-mediated abnormal humoral immunity and oxidative stress damage , thus improving cardiac function and quality of life .

###24281435
BACKGROUND	Ibuprofen ( IBU ) has proved as effective as indomethacin in the pharmacological closure of hemodynamically significant patent ductus arteriosus ( HsPDA ) , with an efficacy inversely related to gestational age ( 57-89 % ) .
OBJECTIVE	This study aimed to establish whether continuous infusions of IBU could be more effective in very low birth weight infants with no additional adverse effects and reduce the need for surgical ligation .
METHODS	A prospective , randomized , double-dummy study was conducted on 112 very low birth weight infants ( mean gestational age 27.2 weeks , SD 2 ; birth weight 1,019 g , SD 330 ) with HsPDA , 56 of whom were given IBU in conventional 15-min intermittent boluses , while the other 56 were administered IBU as a 24-hour continuous infusion , both at standard doses ( 10/5/5 mg/kg ) .
METHODS	Extensive echocardiography was performed before and after treatment , and adverse effects were monitored .
RESULTS	Pharmacological PDA closure was achieved after 1 or 2 IBU courses in 36 of 56 infants ( 64.3 % ) after bolus administration and in 46 of 55 ( 83.6 % ) after continuous infusion ( p = 0.020 ) , and in 9 of 26 ( 34.6 % ) and 24 of 30 ( 80.0 % ) , respectively , in the infants with a gestational age of 23-27 weeks ( p = 0.006 ) .
RESULTS	Sustained pharmacological closure was observed in 38 of 56 infants ( 67.9 % ) after bolus IBU and in 47 of 55 ( 85.5 % ) after continuous infusion ( p = 0.029 ) .
RESULTS	Surgical ligation was used less after continuous infusion than after bolus IBU ( 5.5 vs. 19.6 % ; p = 0.024 ) .
RESULTS	The continuous infusion group had fewer symptoms of necrotizing enterocolitis ( NEC ) , especially in the more preterm infants , while other neonatal morbidity and mortality rates were similar .
CONCLUSIONS	Continuous IBU infusion is more effective than standard boluses for sustained closure of HsPDA , with fewer NEC symptoms and less need for surgical ligation in very low birth weight infants .

###25125223
BACKGROUND	This study aimed at analyzing the prevalence of hepatitis B virus ( HBV ) DNA among hepatitisB surface antigen ( HBsAg ) - negative donations by cobas TaqScreen MPX test ( Roche Molecular Systems ) and discussing the meaning of a reactive minipool ( MP ) that does not resolve to an individual donation ( ID ) - reactive result .
METHODS	Nucleic acid amplification testing ( NAT ) was performed in 12 Chinese blood centers on 826,044 serologic negative donations in MPs of six .
METHODS	MP-reactive pools that were resolved to ID-reactive donations were confirmed by Roche TaqMan viral load assays .
METHODS	Antibody to hepatitisB surface antigen and antibody to hepatitisB core antigen ( anti-HBc ) results were also analyzed .
METHODS	Cycle threshold ( Ct ) values of reactive MPs were analyzed in relation to the probability of pool resolution .
RESULTS	A total of 1267 of 137,674 pools were reactive , of which 839 donations were reactive by ID-NAT .
RESULTS	The MP6 HBV NAT-yield rate lay between 1 in 1600 and 1 in 1000 .
RESULTS	At MP Ct values equal or below 37 , the probability of pool resolution was approximately 80 % .
RESULTS	The prevalence of anti-HBc in ID-reactive donations was 81 % .
RESULTS	The proportion of reactive pools that could not be resolved was 36 % .
RESULTS	The prevalence of anti-HBc in donations implicated in nonresolved MPs was significantly higher than those in nonreactive MPs ( 48 % vs. 37 % , p = 0.016 ) .
CONCLUSIONS	The anti-HBc data suggest that approximately 10 % of nonresolved MPs contain HBV DNA from a low-viral-load occult carrier .
CONCLUSIONS	We consider ID-NAT resolution testing in duplicate to minimize HBV transmission risk associated with transfusing nonreactive donations implicated in reactive MPs .

###24788619
OBJECTIVE	To compare 1-year clinical efficacy of ( 1 ) initial triple disease-modifying antirheumatic drug therapy ( iTDT ) with initial methotrexate ( MTX ) monotherapy ( iMM ) and ( 2 ) different glucocorticoid ( GC ) bridging therapies : oral versus a single intramuscular injection in early rheumatoid arthritis .
METHODS	In a single-blinded randomised clinical trial patients were randomised into three arms : ( A ) iTDT ( methotrexate + sulfasalazine + hydroxychloroquine ) with GCs intramuscularly ; ( B ) iTDT with an oral GC tapering scheme and ( C ) MTX with oral GCs similar to B. Primary outcomes were ( 1 ) area under the curve ( AUC ) of Health Assessment Questionnaire ( HAQ ) and Disease Activity Score ( DAS ) and ( 2 ) the proportion of patients with radiographic progression .
RESULTS	281 patients were randomly assigned to arms A ( n = 91 ) , B ( n = 93 ) or C ( n = 97 ) .
RESULTS	The AUC DAS and HAQ were respectively -2.39 ( 95 % CI -4.77 to -0.00 ) and -1.67 ( 95 % CI -3.35 to 0.02 ) lower in patients receiving iTDT than in those receiving iMM .
RESULTS	After 3 months , treatment failure occurred less often in the iTDT group , resulting in 40 % fewer treatment intensifications .
RESULTS	The difference in treatment intensifications between the arms required to maintain the predefined treatment goal remained over time .
RESULTS	No differences were seen between the two GC bridging therapies .
RESULTS	Respectively 21 % , 24 % and 23 % of patients in arms A , B and C had radiographic progression after 1 year .
RESULTS	Patients receiving iTDT had more adjustments of their medication owing to adverse events than those receiving iMM .
CONCLUSIONS	Treatment goals are attained more quickly and maintained with fewer treatment intensifications with iTDT than with iMM .
CONCLUSIONS	However , no difference in radiographic progression is seen .
CONCLUSIONS	Both GC bridging therapies are equally effective and , therefore , both can be used .
BACKGROUND	ISRCTN26791028 .

###24886388
BACKGROUND	Cysteine proteinases ( CPs ) from papaya ( Carica papaya ) possess anthelmintic properties against human soil-transmitted helminths ( STH , Ascaris lumbricoides , Trichuris trichiura and hookworm ) , but there is a lack of supportive and up-to-date efficacy data .
BACKGROUND	We therefore conducted two randomized controlled trials in pigs to assess the efficacy of papaya CPs against experimental infections with T. suis .
METHODS	First , we assessed efficacy by means of egg ( ERR ) and adult worm reduction rate ( WRR ) of a single-oral dose of 450 mol active CPs ( CP450 ) against low ( inoculum of 300 eggs ) and high ( inoculum of 3,000 eggs ) intensity T. suis infections and compared the efficacy with those obtained after a single-oral dose of 400 mg albendazole ( ALB ) .
METHODS	In the second trial , we determined and compared the efficacy of a series of CP doses ( 45 [ CP45 ] , 115 [ CP115 ] , 225 [ CP225 ] , and 450 [ CP450 ] mol ) against high intensity infections .
RESULTS	CP450 was highly efficacious against both levels of infection intensity , resulting in ERR and WRR of more than 97 % .
RESULTS	For both levels of infection intensity , CP450 was significantly more efficacious compared to ALB by means of WRR ( low infection intensity : 99.0 % vs. 39.0 % ; high infection intensity ; 97.4 % vs. 23.2 % ) .
RESULTS	When the efficacy was assessed by ERR , a significant difference was only observed for high intensity infections , CP450 being more efficacious than ALB ( 98.9 % vs. 59.0 % ) .
RESULTS	For low infection intensities , there was no significant difference in ERR between CP450 ( 98.3 % ) and ALB ( 64.4 % ) .
RESULTS	The efficacy of CPs increased as a function of increasing dose .
RESULTS	When determined by ERR , the efficacy ranged from 2.1 % for CP45 to 99.2 % for CP450 .
RESULTS	For WRR the results varied from -14.0 % to 99.0 % , respectively .
RESULTS	Pairwise comparison revealed a significant difference in ERR and WRR only between CP45 and CP450 , the latter being more efficacious .
CONCLUSIONS	A single dose of 450 mol CPs provided greater efficacy against T. suis infections in pigs than a single-oral dose of 400 mg ALB .
CONCLUSIONS	Although these results highlight the possibility of papaya CPs for controlling human STH , further development is needed in order to obtain and validate an oral formulation for human application .

###24498404
BACKGROUND	School-based intervention studies promoting a healthy lifestyle have shown favorable immediate health effects .
BACKGROUND	However , there is a striking paucity on long-term follow-ups .
BACKGROUND	The aim of this study was therefore to assess the 3 yr-follow-up of a cluster-randomized controlled school-based physical activity program over nine month with beneficial immediate effects on body fat , aerobic fitness and physical activity .
RESULTS	Initially , 28 classes from 15 elementary schools in Switzerland were grouped into an intervention ( 16 classes from 9 schools , n = 297 children ) and a control arm ( 12 classes from 6 schools , n = 205 children ) after stratification for grade ( 1st and 5th graders ) .
RESULTS	Three years after the end of the multi-component physical activity program of nine months including daily physical education ( i.e. two additional lessons per week on top of three regular lessons ) , short physical activity breaks during academic lessons , and daily physical activity homework , 289 ( 58 % ) participated in the follow-up .
RESULTS	Primary outcome measures included body fat ( sum of four skinfolds ) , aerobic fitness ( shuttle run test ) , physical activity ( accelerometry ) , and quality of life ( questionnaires ) .
RESULTS	After adjustment for grade , gender , baseline value and clustering within classes , children in the intervention arm compared with controls had a significantly higher average level of aerobic fitness at follow-up ( 0.373 z-score units [ 95 % - CI : 0.157 to 0.59 , p = 0.001 ] corresponding to a shift from the 50th to the 65th percentile between baseline and follow-up ) , while the immediate beneficial effects on the other primary outcomes were not sustained .
CONCLUSIONS	Apart from aerobic fitness , beneficial effects seen after one year were not maintained when the intervention was stopped .
CONCLUSIONS	A continuous intervention seems necessary to maintain overall beneficial health effects as reached at the end of the intervention .
BACKGROUND	ControlledTrials.com ISRCTN15360785 .

###24419825
BACKGROUND	The objective of this study was to investigate functional results , the amount of time that patients missed from regular working activities , and the incidence of residual mechanical ankle instability following conservative treatment of a first episode of severe lateral ankle ligament sprain ( with articular instability ) .
METHODS	This prospective and randomized study included 186 patients with severe lateral ankle ligament injuries , who were randomly assigned into 2 conservative treatment groups .
METHODS	In group A , participants were treated with a walking boot with weight-bearing allowed , pain management , ice , and elevation with restricted joint mobilization for 3 weeks .
METHODS	In group B , patients were treated with a functional brace for 3 weeks .
METHODS	After this period , patients from both groups were placed in a short , functional brace for an additional 3 weeks , during which they also started a rehabilitation program .
RESULTS	No statistically significant difference was found in pain intensity score between the 2 groups ; however , functional evaluations based on the AOFAS ankle and hindfoot score system showed a statistically significant improvement in the group treated with the functional brace .
RESULTS	In addition , the average recovery period necessary for patients of group B to resume their duties was shorter than that for patients in group A. No significant difference was detected in residual mechanical ankle instability between the 2 groups .
CONCLUSIONS	Patients with severe lateral ankle ligament lesions treated with a functional brace were shown to exhibit somewhat better results than those treated with a walking boot , and both methods presented a very low incidence of residual chronic instability .
CONCLUSIONS	We found adequate conservative treatment was sufficient to reestablish ankle stability and that functional treatment had a marginally better clinical short-term outcome with a shorter average recovery period .
METHODS	Level I , prospective randomized study .

###25218194
BACKGROUND	Efforts to reduce risk of tuberculosis disease in children include development of effective vaccines .
BACKGROUND	Our aim was to test safety and immunogenicity of the new adenovirus 35-vectored tuberculosis vaccine candidate AERAS-402 in infants , administered as a boost following a prime with the Bacille Calmette-Guerin vaccine .
METHODS	In a phase 1 randomised , double-blind , placebo-controlled , dose-escalation trial , BCG-vaccinated infants aged 6-9 months were sequentially assigned to four study groups , then randomized to receive an increasing dose-strength of AERAS-402 , or placebo .
METHODS	The highest dose group received a second dose of vaccine or placebo 56 days after the first .
METHODS	The primary study outcome was safety .
METHODS	Whole blood intracellular cytokine staining assessed immunogenicity .
RESULTS	Forty-two infants received AERAS-402 and 15 infants received placebo .
RESULTS	During follow-up of 182 days , an acceptable safety profile was shown with no serious adverse events or discontinuations related to the vaccine .
RESULTS	AERAS-402 induced a specific T cell response .
RESULTS	A single dose of AERAS-402 induced CD4T cells predominantly expressing single IFN - whereas two doses induced CD4T cells predominantly expressing IFN - , TNF - and IL-2 together .
RESULTS	CD8T cells were induced and were more likely to be present after 2 doses of AERAS-402 .
CONCLUSIONS	AERAS-402 was safe and immunogenic in healthy infants previously vaccinated with BCG at birth .
CONCLUSIONS	Administration of the highest dose twice may be the most optimal vaccination strategy , based on the induced immunity .
CONCLUSIONS	Multiple differences in T cell responses when infants are compared with adults vaccinated with AERAS-402 , in the same setting and using the same whole blood intracellular cytokine assay , suggest specific strategies may be important for vaccination for each population .

###24704290
BACKGROUND	Endoscopic ultrasound fine needle aspiration has a central role in the diagnostic algorithm of solid pancreatic masses .
BACKGROUND	Data comparing the fine needle aspiration performed with different aspiration volume and without aspiration are lacking .
BACKGROUND	We compared endoscopic ultrasound fine needle aspiration performed with the 22 gauge needle with different aspiration volumes ( 10 , 20 and 0 ml ) , for adequacy , diagnostic accuracy and complications .
METHODS	Prospective clinical study at four referral centres .
METHODS	Endoscopic ultrasound fine needle aspiration was performed with a 22G needle with both volume aspiration ( 10 and 20 cc ) and without syringe , in randomly assigned sequence .
METHODS	The cyto-pathologist was blinded as to which aspiration was used for each specimen .
RESULTS	100 patients met the inclusion criteria , 88 completed the study .
RESULTS	The masses had a mean size of 32.2111.24 mm .
RESULTS	Sample adequacy evaluated on site was 87.5 % with 20 ml aspiration vs. 76.1 % with 10 ml ( p = 0.051 ) , and 45.4 % without aspiration ( 20 ml vs. 0 ml p < 0.001 ; 10 ml vs. 0 ml p < 0.001 ) .
RESULTS	The diagnostic accuracy was significantly better with 20 ml than with 10 ml and 0 ml ( 86.2 % vs. 69.0 % vs. 49.4 % p < 0.001 ) .
CONCLUSIONS	A significantly higher adequacy and accuracy were observed with the 20 ml aspiration puncture , therefore performing all passes with this volume aspiration may improve the diagnostic power of fine needle aspiration .

###25742472
BACKGROUND	Mutations affecting RAS genes are now established predictive markers of nonresponse to anti-EGFR antibodies in advanced CRC .
BACKGROUND	This analysis assessed the prognostic and predictive impact of extended RAS and PIK3CA gene mutation status in patients receiving capecitabine plus or minus bevacizumab ( mitomycin C ) in the randomised phase III MAX study .
METHODS	DNA was extracted from archival macrodissected formalin-fixed paraffin-embedded tumour tissue .
METHODS	Mutation status was determined using pyrosequencing , confirmed with Sanger sequencing ( for equivocal RAS ) and correlated with efficacy outcomes .
METHODS	Predictive analyses were undertaken using a test for interaction involving both C vs CB+CBM .
RESULTS	Of the available 280 of the 471 ( 59.4 % ) patients , mutations in KRAS exons 2 , 3 and 4 and NRAS 2 , 3 and 4 were as follows : 32 % , 2.9 % , 2.2 % , 1.4 % , 0.7 % and 0 % ( total RAS MT 39 % ) .
RESULTS	The PIK3CA MT rate was 7.5 % exon 9 and 3.6 % exon 20 .
RESULTS	Extended RAS gene mutation status ( WT vs MT ) had no prognostic impact for PFS ( HR 0.91 ( 0.71-1 .17 ) ) or OS ( HR 0.95 ( 0.71-1 .25 ) ) .
RESULTS	The RAS gene mutation status was not predictive of the effectiveness of bevacizumab for PFS ( HR 0.56 ( 0.37-0 .85 ) for RAS MT and HR 0.69 ( 0.5-0 .97 ) for RAS WT ; P for interaction 0.50 ) .
RESULTS	The PIK3CA mutation was neither predictive for bevacizumab effect nor prognostic .
CONCLUSIONS	Of KRAS exon 2 WT patients , 10 % had additional RAS mutations .
CONCLUSIONS	Neither all RAS gene mutation status nor PIK3CA mutation status was prognostic for PFS or OS , or predictive of bevacizumab outcome in patients with advanced CRC .

###24882587
OBJECTIVE	In the present study , we calculated the success rate of the modified Epley maneuver and determined the effectiveness of post-maneuver positional restriction in terms of the prevention of early and late recurrence .
METHODS	The present study was conducted on 78 patients who had unilateral benign paroxysmal positional vertigo ( BPPV ) of the posterior semicircular canal ( SCC ) and who were treated in the Otorhinolaryngology Department of Susehri State Hospital .
METHODS	The Dix-Hallpike test was performed on all patients .
METHODS	After the involved canal was identified using this test , we guided patients through the modified Epley repositioning maneuver .
METHODS	A maximum of two maneuvers were performed in the same session .
METHODS	The patients were randomly divided into two groups .
METHODS	One group was not advised any positional restriction , while the second group was advised positional restriction for 10 days after the procedure .
METHODS	Recurrences during 1-90 days after the treatment were noted as early recurrences , while those that occurred after 90 days were noted as late recurrences .
RESULTS	In the restriction group ( n = 39 ) , repositioning was successful after a single maneuver in 32 ( 82.05 % ) patients and after two maneuvers in 5 ( 12.8 % ) patients .
RESULTS	Repositioning failed in two ( 5.1 % ) patients .
RESULTS	In the non-restriction group ( n = 39 ) , repositioning was successful after a single maneuver in 31 ( 79.4 % ) patients and after two maneuvers in 6 ( 15.3 % ) patients .
RESULTS	Repositioning failed in two ( 5.1 % ) patients .
RESULTS	Thus , the success rate was 94.8 % in each group .
RESULTS	Early recurrence occurred in 3 ( 8.1 % ) of 37 patients in the restriction group and 2 ( 5.4 % ) of 37 patients in the non-restriction group ( p > 0.05 ) .
RESULTS	Late recurrence occurred in 5 ( 13.5 % ) of 37 patients in both the restriction and non-restriction groups ( p > 0.05 ) .
CONCLUSIONS	Postural restriction after a canalith repositioning procedure does not improve procedural success or decrease early and late recurrence rates .
CONCLUSIONS	However , the number of patients was too small to detect a difference between both treatment groups .

###25668557
BACKGROUND	Ethanol rapidly eradicated experimental biofilm .
BACKGROUND	Clinical studies of ethanol lock to prevent catheter-related infections ( CRIs ) suggest preventive efficacy .
BACKGROUND	No such studies have been done in intensive care units ( ICU ) .
OBJECTIVE	To determine whether ethanol lock decreases the risk of major CRI in patients with short-term dialysis catheters ( DCs ) .
METHODS	A randomized , double-blind , placebo-controlled trial was performed in 16 ICUs in seven university hospitals and one general hospital in France between June 2009 and December 2011 .
METHODS	Adults with insertion of a nontunneled , nonantimicrobial-impregnated double-lumen DC for an expected duration greater than 48 hours , to perform renal-replacement therapy or plasma exchange , were randomly allocated ( 1:1 ) to receive a 2-minute catheter lock with either 60 % wt/wt ethanol solution ( ethanol group ) or 0.9 % saline solution ( control group ) at the end of DC insertion and after each renal-replacement therapy or plasma exchange session .
METHODS	The main outcome was major CRI defined as either catheter-related clinical sepsis without bloodstream infection or catheter-related bloodstream infection during the ICU stay .
RESULTS	The intent-to-treat analysis included 1,460 patients ( 2,172 catheters , 12,944 catheter-days , and 8,442 study locks ) .
RESULTS	Median DC duration was 4 days ( interquartile range , 2-8 ) and was similar in both groups .
RESULTS	Major CRI incidence did not differ between the ethanol and control groups ( 3.83 vs. 2.64 per 1,000 catheter-days , respectively ; hazard ratio , 1.55 ; 95 % confidence interval , 0.83-2 .87 ; P = 0.17 ) .
RESULTS	No significant differences occurred for catheter colonization ( P = 0.57 ) or catheter-related bloodstream infection ( P = 0.99 ) .
CONCLUSIONS	A 2-minute ethanol lock does not decrease the frequency of infection of DCs in ICU patients .
CONCLUSIONS	Clinical trial registered with www.clinicaltrials.gov ( NCT 00875069 ) .

###24401754
OBJECTIVE	Comparison of efficacy and safety of two different regimens of vitamin D-600 000 IU as a single intramuscular dose , and 60 000IU orally once a week for 10 weeks-in treatment of nutritional rickets .
METHODS	Children with nutritional rickets ( age : 0.5-5 years , n = 61 ) were randomized to receive either 60 000IU vitamin D orally once a week for 10 weeks or 600 000IU single intramuscular injection .
METHODS	Serum calcium , phosphate , alkaline phosphatase , urinary calcium/creatinine ratio , serum 25 hydroxy vitamin D and radiological score were compared at 12-week follow-up .
RESULTS	No difference was found in efficacy of the two regimens on comparing biochemical and radiological parameters .
RESULTS	Serum 25 hydroxy vitamin D > 100 ng/ml was found in two children in the oral group and one child in the intramuscular group .
RESULTS	No child developed hypercalcemia or hypercalciuria after starting treatment .
CONCLUSIONS	Staggered oral and one-time intramuscular administrations of 600 000IU vitamin D are equally effective and safe in treatment of nutritional rickets .

###24495890
BACKGROUND	Psychiatric disorders are common among patients with irritable bowel syndrome ( IBS ) which may make a psychiatric evaluation appropriate .
BACKGROUND	The Hospital Anxiety and Depression Scale ( HADS ) has been recommended internationally for screening .
BACKGROUND	The Common Mental Disorder Questionnaire ( CMDQ ) is a novel Danish instrument recommended for use in general practice , but it lacks validation .
BACKGROUND	The objective of this study was to test the reliability and the convergent validity of the anxiety and depression subscales of the CMDQ and the HADS in patients with IBS .
METHODS	A total of 149 patients with IBS completed the CMDQ and the HADS twice in a year .
METHODS	Data were analysed with respect to internal consistency ( Cronbach 's alpha ) , agreement on case identification ( ) and correlation between scores ( Spearman 's rank correlation coefficient ) .
RESULTS	All subscales showed satisfactory internal consistency .
RESULTS	Cases identified by the CMDQ 's anxiety and depressions subscales differed considerably from those identified with the HADS with only fair-moderate agreement , while the correlation between the scores on the CMDQ and the HADS was only moderate for both anxiety and depressions .
CONCLUSIONS	The subscales for anxiety disorder and depression on the CMDQ showed internal consistency , but only fair to moderate agreement and correlation , which yielded an unsatisfying convergent validity compared to the HADS .
CONCLUSIONS	More studies in different populations and research on the cut-off values for possible cases could make the CMDQ more useful .
BACKGROUND	Danish Council for Independent Research ; Region Zealand 's Health Sciences Research Foundation ; Councils for Quality Assurance in Primary Care in Region Zealand .
BACKGROUND	NCT00659763 .

###25414173
OBJECTIVE	Delayed ischemic neurological deficits ( DINDs ) are a major contributing factor for poor outcome in patients with subarachnoid hemorrhage .
OBJECTIVE	In this trial , we investigated the therapeutic potential of prostacyclin , an endogen substance with known effect on vascular tone and blood flow regulation , on factors related to DIND .
METHODS	This trial is a single-center , randomized , blinded , clinical , pilot trial with 3 arms .
METHODS	Ninety patients were randomized to continuous infusion of prostacyclin 1 ng/kg per minute , prostacyclin 2 ng/kg per minute , or placebo .
METHODS	The intervention was initiated day 5 after subarachnoid hemorrhage and discontinued day 10 .
METHODS	Primary outcome was the difference in change from baseline in global cerebral blood flow .
METHODS	Secondary outcome measures were occurrence of DIND , angiographic vasospasm , and clinical outcome at 3 months .
RESULTS	No statistically significant difference in change of global cerebral blood flow was found between the intervention groups .
RESULTS	The observed incidence of DIND and angiographic vasospasm was markedly higher in the placebo group , although this difference was not statistically significant .
RESULTS	No statistically significant differences in safety parameters or clinical outcome were found between the 3 groups .
CONCLUSIONS	Administration of prostacyclin to patients with subarachnoid hemorrhage may be safe and feasible .
CONCLUSIONS	Global cerebral blood flow after subarachnoid hemorrhage is not markedly affected by administration of prostacyclin in the tested dose range .
CONCLUSIONS	It may be possible that the observed reduction in the point estimates of DIND and vasospasm in the prostacyclin groups represents an effect of prostacyclin as this trial was not powered to investigate the effect of prostacyclin on these outcomes .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01447095 .

###25433202
BACKGROUND	Although the use of drug-eluting stents ( DESs ) in patients with coronary artery disease has contributed to a significant reduction in in-stent restenosis and repeat revascularization , treating diffuse long lesions using DESs remains challenging due to the high rates of in-stent restenosis and stent thrombosis .
BACKGROUND	Intravascular ultrasound ( IVUS ) provides tomographic images of coronary vascular structure and is useful for evaluating lesion morphology and stent optimization during percutaneous coronary intervention .
BACKGROUND	However , it remains controversial whether IVUS guidance in DES implantation for long coronary lesions could reduce adverse clinical outcomes .
OBJECTIVE	We hypothesize that the long-term clinical outcomes of IVUS-guided DES implantation would be superior to those of angiography-guided DES implantation in a subset of patients with long coronary lesions .
METHODS	This study is a randomized , prospective , multi-center trial comparing the long-term clinical outcomes of IVUS-guided and angiography-guided everolimus-eluting stent implantation in patients with long coronary lesions ( implanted stent 28 mm in length ) .
METHODS	The primary end point is a composite of major adverse cardiac events , including cardiac death , target lesion-related myocardial infarction , or target lesion revascularization at 1 year following intervention .
METHODS	A total of 1,400 patients will be required to be enrolled according to sample size calculations .
CONCLUSIONS	This study will test the hypothesis that IVUS guidance improves long-term clinical outcomes in patients treated with everolimus-eluting stents for long coronary lesions compared with angiographic guidance .

###24731898
OBJECTIVE	Constipation has been identified as a worldwide health problem among elderly people .
OBJECTIVE	Currently , it is not effectively relieved by the use of laxatives and lifestyle modification .
OBJECTIVE	Previous studies reported promising results in managing constipation with auricular acupressure ( AA ) , although its effectiveness was not affirmed .
OBJECTIVE	This study is to evaluate the complementary effects of AA in relieving constipation symptoms and in promoting disease-specific health-related quality of life ( HRQOL ) among elderly residential care home ( RCH ) residents in Hong Kong .
METHODS	Randomized placebo-controlled trial .
METHODS	Elderly RCH .
METHODS	Ninety-nine participants were randomly assigned to either experimental group ( AA using auricular plasters with magnetic pellets ) , placebo-controlled group ( AA using auricular plasters with Semen Vaccariae ) , or usual care group ( AA using auricular plasters only ) .
METHODS	AA was applied onto seven auricular acupoints for 10 days .
METHODS	Constipation symptoms and disease-specific HRQOL were measured before AA , at the completion of AA ( D10 ) , and at the 10th-day follow-up time ( D20 ) .
RESULTS	Significant grouptime interaction effect was found in the change of satisfaction subscale between the experimental group and placebo-controlled group at D10 ( p = 0.016 ) and D20 ( p = 0.016 ) relative to the baselines .
RESULTS	For both constipation symptoms and disease-specific HRQOL , the experimental group demonstrated the greatest improvement after receiving AA at both D10 and D20 compared with the other two groups .
CONCLUSIONS	The current findings indicated positive clinical value of AA with magnetic pellets in managing constipation in elderly RCH residents .
CONCLUSIONS	AA was also found to be a safe and acceptable intervention .

###24339418
OBJECTIVE	The myeloid-related proteins 8 and 14 ( MRP-8 / MRP-14 ) and neutrophil-derived S100A12 are biomarkers of inflammation .
OBJECTIVE	They can be used to determine the relapse risk in patients with juvenile idiopathic arthritis ( JIA ) after stopping antiinflammatory treatment .
OBJECTIVE	In this study , we tested the performance of different enzyme-linked immunosorbent assays ( ELISAs ) in order to validate systems available for routine use .
METHODS	MRP-8 / MRP-14 and S100A12 serum concentrations of 188 JIA patients in remission were analyzed .
METHODS	Commercially available test systems were compared to experimental ELISAs established in house .
METHODS	The ability of the assays to identify JIA patients at risk for relapse was analyzed .
RESULTS	For MRP-8 / MRP-14 , the PhiCal Calprotectin and Buhlmann MRP8/14 Calprotectin ELISAs revealed hazard ratios of 2.3 and 2.1 , respectively .
RESULTS	For S100A12 , the CircuLex S100A12/EN-RAGE ELISA revealed a hazard ratio of 3.1 .
RESULTS	The commercial assays allowed a JIA relapse prediction that was at least comparable to the experimental ELISAs .
CONCLUSIONS	For the prediction of JIA relapse after stopping medication , the biomarkers MRP-8 / MRP-14 and S100A12 can be determined by using assays that are available for routine use .
CONCLUSIONS	The tested commercial MRP-8 / MRP-14 and S100A12 ELISAs showed a performance comparable to well-established experimental ELISA protocols when assay-specific cutoffs for the indication of relapse prediction are thoroughly applied .

###26505596
OBJECTIVE	The efficacy and safety of long-acting - agonists ( LABAs ) have been questioned .
OBJECTIVE	Black populations may be disproportionately affected by LABA risks .
OBJECTIVE	To compare the effectiveness and safety of tiotropium vs LABAs , when used with inhaled corticosteroids ( ICS ) in black adults with asthma and to determine whether allelic variation at the Arg16Gly locus of the 2-adrenergic receptor ( ADRB2 ) geneis associated with treatment response .
METHODS	A multisite ( n = 20 ) , open-label , parallel-group , pragmatic randomized clinical trial conducted from March 2011 through July 2013 , enrolling black adults with moderate to severe asthma in the United States .
METHODS	Patients eligible for , or receiving , step 3 or step 4 combination therapy per National Heart , Lung , and Blood Institute guidelines , received ICS plus either once-daily tiotropium ( n = 532 ) or twice-daily LABAs ( n = 538 , ) and were followed up for up to 18 months .
METHODS	Patients underwent genotyping , attended study visits at baseline , 1 , 6 , 12 , and 18 months , and completed monthly questionnaires .
METHODS	The primary outcome was time to asthma exacerbation , defined as a worsening asthma event requiring oral or parenteral corticosteroids .
METHODS	Secondary outcomes included patient-reported outcomes ( Asthma Quality of Life Questionnaire , Asthma Control Questionnaire [ ACQ ] , Asthma Symptom Utility Index , and Asthma Symptom-Free Days questionnaire ) , spirometry ( FEV1 ) , rescue medication use , asthma deteriorations , and adverse events .
RESULTS	There was no difference between LABA+ICS vs tiotropium + ICS in time to first exacerbation ( mean No .
RESULTS	of exacerbations/person-year , 0.42 vs 0.37 ( rate ratio , 0.90 [ 95 % CI , 0.73 to 1.11 ] , log-rank P = .31 ) .
RESULTS	There was no difference in change in FEV1 at 12 months ( 0.003 L for LABA+ICS vs -0.018 L for tiotropium + ICS ; between-group difference , 0.020 [ 95 % CI , -0.021 to 0.061 ] , P = .33 ) and at 18 months ( -0.053 L vs -0.078 L ; between-group difference , 0.025 [ 95 % CI , -0.045 to 0.095 ] , P = .49 ) .
RESULTS	There were no differences in ACQ score at 18 months ( change in score from baseline , -0.68 for LABA+ICS vs -0.72 for tiotropium + ICS ; between-group difference , 0.04 [ 95 % CI , -0.18 to 0.27 ] , P = .70 ) .
RESULTS	There were no differences in other patient-reported outcomes .
RESULTS	Arg16Gly ADRB2 alleles were not associated with differences in the effects of tiotropium + ICS vs LABA+ICS ( hazard ratio for time to first exacerbation , 0.84 [ 95 % CI , 0.47 to 1.51 ] for Arg/Arg vs 0.85 [ 95 % CI , 0.63 to 1.15 ] for Arg/Gly or Gly/Gly , P = .97 ) .
CONCLUSIONS	Among black adults with asthma treated with ICS , adding a LABA did not improve time to asthma exacerbation compared with adding tiotropium .
CONCLUSIONS	These findings were not affected by polymorphisms at the Arg16Gly locus of ADRB2 .
CONCLUSIONS	These findings do not support the superiority of LABA+ICS compared with tiotropium + ICS for black patients with asthma .
BACKGROUND	ClinicalTrials.gov identifier : NCT01290874 .

###24915941
BACKGROUND	Endoscopic and clinical recurrence of Crohn 's disease ( CD ) appears in up to 80 and 30 % of patients , respectively , 1 year after surgery .
BACKGROUND	Both infliximab ( IFX ) and adalimumab ( ADA ) have been demonstrated to be effective in reducing the possibility of recurrence after surgery , but head-to-head studies have not been performed so far .
BACKGROUND	The aim of this open-label prospective study was to compare endoscopic , histological and clinical recurrence after 1 year of treatment with IFX or ADA as postoperative prophylaxis in CD patients with a high risk of recurrence .
METHODS	Consecutive CD patients who underwent curative ileocolonic resection were randomized to receive IFX or ADA for 1 year .
METHODS	Co-primary endpoints were endoscopic , histological and clinical recurrence after 12 months of therapy .
RESULTS	Twenty consecutive CD patients ( 9 males and 11 females ; median age 32.5 years , range 20-39 years ) were enrolled after undergoing curative ileocolonic resection .
RESULTS	Among the 10 patients treated with IFX , 2 ( 20 % ) had endoscopic recurrence compared to 1 ( 10 % ) in the group of 10 ADA patients ( p = 1.0 ) .
RESULTS	Three out of 10 ( 30 % ) IFX patients and 2 out of 10 ( 20 % ) ADA patients had histological recurrence ( p = 1.0 ) .
RESULTS	No significant clinical differences were found between the two groups .
CONCLUSIONS	IFX and ADA were similar in preventing histological , endoscopic and clinical recurrence after curative ileocolonic resection in high risk CD patients .

###25157002
BACKGROUND	Growth impairment is a known complication of sickle cell disease .
BACKGROUND	Effects of hydroxyurea ( HU ) on growth in very young children are not known .
METHODS	Height , weight , BMI , and head circumference ( HC ) were compared with World Health Organization ( WHO ) standards in BABY HUG , a multicenter , randomized , double-blinded , placebo-controlled 2-year clinical trial of HU in 193 children 9 to 18 months of age .
METHODS	Anthropometric data were closely monitored and converted to z scores by using WHO standardized algorithms for descriptive analyses .
METHODS	The treatment and placebo groups were compared longitudinally by using a mixed model analysis .
RESULTS	At entry , the z scores of BABY HUG children were higher than WHO norms .
RESULTS	After 2 years of HU or placebo treatment , there were no significant differences between the groups , except for the mean HC z scores at study exit ( HU : +0.8 versus placebo : +1.0 , P = .05 ) .
RESULTS	Baseline z scores were the best predictors of z scores at study exit .
RESULTS	The absolute neutrophil count , absolute reticulocyte count , and total white blood cell count had significant negative correlations with growth measures .
CONCLUSIONS	Both groups had normal or near normal anthropometric measures during the study .
CONCLUSIONS	The HC z scores at study entry and exit were slightly greater than WHO norms .
CONCLUSIONS	Higher baseline white blood cell count , absolute reticulocyte count , and absolute neutrophil count were associated with poorer growth .
CONCLUSIONS	The significance of the slightly lower HC in the treatment group at study exit is not clear .
CONCLUSIONS	Trends toward normalization of weight and height and effects on HC will be monitored in ongoing BABY HUG follow-up studies .

###24833726
BACKGROUND	Intraoperative recruitment manoeuvres ( RMs ) combined with PEEP reverse the decrease in functional residual capacity ( FRC ) associated with anaesthesia and improve intraoperative oxygenation .
BACKGROUND	Whether these benefits persist after operation remains unknown .
BACKGROUND	We tested the hypothesis that intraoperative RMs associated with PEEP improve postoperative spirometry including FRC and reduce the incidence of postoperative hypoxaemia in morbidly obese ( MO ) patients undergoing laparoscopic gastric bypass .
METHODS	After IRB approval and informed consent , 50 MO patients undergoing laparoscopic gastric bypass under volume-controlled ventilation ( tidal volume 6 ml kg ( -1 ) of IBW ) were randomly ventilated with either 10 cm HO PEEP or with 10 cm HO PEEP and one RM carried out after induction of pneumoperitoneum , and another after exsufflation .
METHODS	Anaesthesia and analgesia were standardized .
METHODS	Spirometry was assessed before operation and 24 h after surgery .
METHODS	Postoperative oxygenation and the apnoea-hypopnoea index ( AHI ) were recorded during the first postoperative night .
RESULTS	Age , BMI , and STOP BANG score were similar in both groups .
RESULTS	FRC decrease after surgery was minimal [ 0.15 ( 0.14 ) litre in control and 0.38 ( 0.19 ) litre in the RM group ] and similar between the groups ( P = 0.35 ) .
RESULTS	FVC , FEV1 , mean [ Formula : see text ] , percentage of time spent with [ Formula : see text ] below 90 % , and AHI did not differ significantly between the groups .
CONCLUSIONS	This study demonstrates that when added to a protective mechanical ventilation combining low tidal volume and high PEEP , two RMs do not improve postoperative lung function including FRC , arterial oxygenation , and the incidence of obstructive apnoea in MO patients after laparoscopic upper abdominal surgery .
BACKGROUND	EudraCT 2011-000999-33 .

###25796417
BACKGROUND	Colorectal stents have been available as a management option in obstruction for 23 years , yet there is little randomized evidence of their effectiveness .
BACKGROUND	This study investigated current surgeon-related barriers to conducting a randomized , controlled trial ( RCT ) of colorectal stent insertion for obstruction in patients with colorectal cancer .
METHODS	A binational survey of current members of the Colorectal Surgical Society of Australia and New Zealand was conducted by a mailed questionnaire assessing perceived barriers to adoption of colonic stents and willingness to participate in future multicentre randomized controlled trials , and surgeons ' treatment preferences in 16 hypothetical clinical scenarios .
RESULTS	Of 148 eligible surgeons , 96 ( 65 % ) responded .
RESULTS	Colonic stenting was available to 98 % of respondents .
RESULTS	In the clinical setting of colorectal obstruction , only 29 % ( 95 % CI , 20-39 % ) of surgeons expressed a willingness to participate in a RCT involving colonic stents in the curative setting .
RESULTS	More than 70 % of surgeons preferred the use of stents in unfit patients for palliation , and preferred surgery in fit patients with curable disease .
RESULTS	In the curative setting , most respondents considered colonic stents not cost effective ( 90 % ; 95 % CI , 82-94 % ) and believed that their patients would not prefer stents over surgery ( 80 % ; 95 % CI , 71-87 % ) .
CONCLUSIONS	This study highlights the limitation to conducting a future randomized controlled trial to assess the efficacy of colonic stenting , especially in the curative setting , based on surgeon preference , despite the lack of level I evidence .

###25466315
BACKGROUND	The aim of this multicenter , prospective , randomized , crossover trial is to compare , in critical care patients receiving insulin infusion therapy ( IIT ) , the pharmacodynamic of Humulin insulin ( Hlin ) , currently used as `` standard of care , '' and Humalog insulin ( Hlog ) , a shorter acting insulin formulation .
BACKGROUND	This was measured as extent and duration of the carryover effect of insulin treatment , with the latter calculated as ratio between blood glucose concentration ( BGC ) reduction during and after IIT .
METHODS	Twenty-eight patients treated in an intensive care unit and receiving full nutritional support were randomly assigned to Hlin or Hlog as first treatment .
METHODS	Insulin was infused at a constant rate in patients presenting with BGC greater than or equal to 180 mg/dL ( 0.04 U/kg per hour ) and was discontinued when BGC was less than or equal to 140 mg/dL ( therapeutic BGC drop ) .
METHODS	Further reductions in BGC after discontinuation of insulin infusion were recorded ( postinfusional BGC drop ) .
METHODS	During the study period , whole blood BGC was measured every 30 minutes .
METHODS	A minimal 6-hour washout interval was maintained between treatments with the 2 types of insulin .
METHODS	The primary end point was the extent ( calculated as ratio between the therapeutic BGC drop and the postinfusional BGC drop ) and duration of the carryover effect .
RESULTS	Treatment with Hlog , as compared with Hlin , was associated with a less profound carryover effect as well as a briefer duration of carryover ( median , 0.40 vs 0.62 ; P < .001 ; median , 1 vs 1.5 hours ; P < .001 ) .
CONCLUSIONS	The use of constant Hlog infusion for IIT , when compared with Hlin at the same dose , is associated with a less profound carryover effect on BGC after discontinuation of IIT , a briefer duration of carryover , a faster BGC drop during infusion , and a quicker BGC rise after discontinuation .
CONCLUSIONS	These characteristics suggest that Hlog IIT may be preferable for use in critically ill patients .

###25154525
BACKGROUND	Understanding peer effect is potentially important for finding ways to combat the obesity epidemic .
BACKGROUND	Nevertheless , it is not clear whether a peer effect exists because of the composition of the peer group , because the group members have similar , unobserved individual characteristics , or because of an endogenous effect .
METHODS	This issue is addressed here by using a unique longitudinal data set of 573 schoolchildren attending state schools in the Municipality of Aalborg , Denmark , during 2008-2010 .
METHODS	To identify the spillover effect of a targeted intervention on peers , we use a difference-in-differences approach .
RESULTS	A targeted health intervention reduced body mass index ( BMI ) among overweight , inactive individuals and , more interestingly , that BMI among the nontreated peers was reduced by 1.04 % .
CONCLUSIONS	The analysis suggests that individually targeted health intervention has a health benefit beyond the treated individual , which needs to be included when evaluating targeted policies aiming to combat childhood overweight and inactivity .

###24316936
OBJECTIVE	To determine the effect of Parkinson 's disease-weight bearing exercise for better balance ( PD-WEBB ) exercise on balance impairment and falls in people with Parkinson 's disease ( PD ) .
METHODS	A single-blind , randomized controlled clinical trial was conducted .
METHODS	The falls efficacy scale score , unified Parkinson disease rating scale ( UPDRS ) score and Mini-BESTest score were measured and compared between a PD-WEBB group and a control group .
RESULTS	The falls efficacy scale score , UPDRS-2 score , UPDRS-3 score and Mini-BESTest score were improved in the PD-WEBB group compared with the control group ( P < 0.05 ) , with no significant change in UPDRS-1 score between the two groups .
CONCLUSIONS	PD-WEBB training can significantly improve the balance impairment and quality of life to prevent falls .
CONCLUSIONS	PD-WEBB training is suitable for PD patients in China , and is a reasonable , effective and sustainable training of family and community assessment model .

###26063693
BACKGROUND	Hypertension is a major , modifiable risk factor for cardiovascular and kidney disease and premature mortality that is improved by the DASH ( Dietary Approaches to Stop Hypertension ) diet .
BACKGROUND	The DASH diet emphasizes increased consumption of fruit and vegetables , whole grains , low-fat dairy , nuts , and poultry and fish and reduced intakes of fats , red meats ( including pork ) , sodium , and added sugars .
OBJECTIVE	We sought to evaluate whether the consumption of lean pork compared with the consumption of chicken and fish as the predominant protein source in a DASH-style diet affected blood pressure ( BP ) control in men and women with elevated BP .
METHODS	In a randomized crossover study , 13 women and 6 men [ mean SEM age : 61 2 y ; BMI ( in kg/m ) : 31.2 1.4 ] with elevated BP [ systolic blood pressure ( SBP ) / diastolic blood pressure ( DBP ) : 130 2/85 2 mm Hg ] consumed a DASH-style diet for two 6-wk controlled dietary interventions ( with a 4-wk diet washout between interventions ) with either lean pork [ DASH diet with pork ( DASH-P ) ] or chicken and fish [ DASH diet with chicken and fish ( DASH-CF ) , the control diet ] as the major protein source ( 55 % of total protein intake ) .
METHODS	SBP and DBP were measured manually and with a 24-h BP monitoring system on 3 d before and 3 d at the end of each diet intervention .
RESULTS	Preintervention manual BP ( DASH-P : 130/84 2/1 mm Hg ; DASH-CF : 129/84 2/1 mg Hg ) and postintervention manual BP ( DASH-P : 122/79 2/1 mm Hg ; DASH-CF : 123/78 3/1 ) were not different between the DASH-P and DASH-CF .
RESULTS	Consumption of these DASH-style diets for 6 wk reduced all measures of BP ( P < 0.05 ) with no differences in responses between the DASH-CF and DASH-P .
CONCLUSIONS	The results indicate that adults with elevated BP may effectively incorporate lean pork into a DASH-style diet for BP reduction .

###24695927
BACKGROUND	Percutaneous pins used in the surgical fixation of fractures in children are often removed in the outpatient clinic without the administration of analgesia .
BACKGROUND	Pin removal can be a cause of anxiety for children , parents , and caregivers .
BACKGROUND	Relatively little is known about the requirement of analgesia for this procedure .
BACKGROUND	In a randomized controlled trial , we evaluated whether oral acetaminophen or ibuprofen reduced the pain experienced during pin removal .
METHODS	Participating in the study were 240 children between the ages of five and twelve years who had two or three percutaneous pins in the elbow following treatment of a supracondylar humeral fracture or a lateral humeral condyle fracture with closed reduction and percutaneous pinning .
METHODS	The patients were randomized into one of three groups ( n = 80 ) allocated to receive acetaminophen , ibuprofen , or vitamin C ( placebo ) an hour before pin removal .
METHODS	A pain score was obtained and heart rate measured before pin removal , immediately following the procedure , and ten minutes after pin removal .
RESULTS	No significant differences were found among the study groups in terms of the demographic data of sex , age , side of injury , or number of pins .
RESULTS	Pain score and heart rate did not exhibit differences that were either statistically significant or clinically relevant .
RESULTS	The change from baseline did not differ significantly among the groups for either measure at either of the follow-up times post pin removal .
RESULTS	Immediately after pin removal , the mean difference in pain score ( and 95 % confidence interval [ CI ] ) between the acetaminophen group and the ibuprofen group was 0.10 ( -1.03 to 1.23 ) ; between the acetaminophen group and the placebo group , 0.35 ( -0.78 to 1.48 ) ; and between the ibuprofen group and the placebo group , 0.25 ( -0.88 to 1.38 ) .
RESULTS	The CIs excluded a clinically relevant difference .
RESULTS	Pain scores and heart rates returned to preprocedural baseline levels within ten minutes following pin removal .
CONCLUSIONS	Neither acetaminophen nor ibuprofen significantly reduced the pain score or heart rate associated with percutaneous pin removal in children as compared with the placebo .
CONCLUSIONS	The oral analgesics administered were clinically equivalent to the placebo .
CONCLUSIONS	These results suggest that non-narcotic analgesia use does not significantly reduce pain or heart rate associated with percutaneous pin removal in children .

###24246616
BACKGROUND	Several studies have suggested that proton-pump inhibitors ( PPIs ) , mostly omeprazole , interact with clopidogrel efficacy by inhibiting the formation of its active metabolite via CYP2C19 inhibition .
BACKGROUND	Whether this occurs with all PPIs is a matter of debate .
BACKGROUND	As rabeprazole is a less potent CYP2C19 inhibitor than other PPIs , we studied the interaction between rabeprazole and the antiplatelet actions and pharmacokinetics of clopidogrel .
OBJECTIVE	To demonstrate the non-inferiority of rabeprazole over placebo using change in platelet reactivity index ( PRI ; vasodilator-stimulated phosphoprotein [ VASP ] assay ) in a predefined population of good clopidogrel responders .
OBJECTIVE	Omeprazole was used as the positive control .
METHODS	In this randomized three-period crossover study in healthy volunteers , 36 healthy men received clopidogrel ( 75 mg/day for 7 days ) with placebo , omeprazole ( 20mg/day ) or rabeprazole ( 20mg/day ) .
METHODS	Clopidogrel antiplatelet effects and disposition kinetics were assessed on day 7 of combination therapy .
METHODS	Non-inferiority threshold was predefined as an upper limit of the 90 % confidence interval for the difference in change in PRI between placebo and rabeprazole of < 10 % in good clopidogrel responders .
RESULTS	In good clopidogrel responders ( inhibition of VASP index > 30 % ) , the clopidogrel antiplatelet effect remained non-inferior to placebo during rabeprazole ( difference 3.4 % [ -1.7 ; 8.5 ] ) but not omeprazole ( difference 7.5 % [ 2.5 ; 12.6 ] ) co-administration .
RESULTS	The AUC0-24 and Cmax of active clopidogrel metabolite decreased with both omeprazole and rabeprazole , and conditions of bioequivalence were not met , except for AUC0-24 with rabeprazole .
CONCLUSIONS	Rabeprazole does not interact with clopidogrel to the same extent as omeprazole .
CONCLUSIONS	However , under our experimental conditions and proton-pump inhibitor doses , there was no significant pharmacodynamic interaction between rabeprazole or omeprazole and clopidogrel , despite a significant decrease in the formation of clopidogrel active metabolite .

###24355670
BACKGROUND	Well-being encompasses physical , psychological , and social aspects of health and predicts healthcare utilization and expenditures .
BACKGROUND	Despite their potential clinical impact , interventions that leverage social network effects to target well-being are uncommon .
OBJECTIVE	Using a pragmatic design , to evaluate the effectiveness of an online well-being intervention as part of ongoing program development .
METHODS	Randomized , placebo-controlled , parallel-group trial with longitudinal outcome measurements at baseline , 30 days , and 90 days .
METHODS	A total of 1503 U.S.-based adults were enrolled .
METHODS	Recruitment , eligibility verification , and baseline data collection were conducted entirely online ; follow-up took place online or by phone .
METHODS	The study was conducted in 2012 .
METHODS	A multimodal e-mail - , web - , and mobile-based intervention ( Daily Challenge ) , in which participants receive daily suggestions of small health actions that they complete in a social environment .
METHODS	A traditional weekly health newsletter served as control .
METHODS	Overall well-being as measured by the Individual-level Well-Being Assessment and Scoring Method ( scale : 0 to 100 ) .
RESULTS	Follow-up rates reached 68.7 % ( n = 1032 ) at 30 days and 62.6 % ( n = 940 ) at 90 days .
RESULTS	Overall , 84.6 % of treatment group participants visited the website , and 76.5 % opened program e-mails ( vs 51.1 % in the control group ) .
RESULTS	Daily Challenge improved well-being significantly more than control at 30 days ( 2.27 points , p = 0.004 ) and at 90 days ( 2.35 points , p = 0.004 ) .
RESULTS	A dose response for intensity of use was observed at 30 days ( p = 0.001 ) and 90 days ( p = 0.003 ) .
RESULTS	Well-being improvement was greater in participants with than without social ties in the program ( at 30 days : p = 0.02 ; at 90 days : p = 0.003 ) .
CONCLUSIONS	A multimodal online intervention leveraging social network effects significantly improved well-being over control .
CONCLUSIONS	Higher levels of participation as well as increasing levels of social integration were associated with greater improvement in well-being .
BACKGROUND	www.clinicaltrials.gov ( NCT01586949 ) .

###25886178
BACKGROUND	Alcohol is a major global threat to public health .
BACKGROUND	Although the main burden of chronic alcohol-related disease is in adults , its foundations often lie in adolescence .
BACKGROUND	Alcohol consumption and related harm increase steeply from the age of 12 until 20 years .
BACKGROUND	Several trials focusing upon young people have reported significant positive effects of brief interventions on a range of alcohol consumption outcomes .
BACKGROUND	A recent review of reviews also suggests that electronic brief interventions ( eBIs ) using internet and smartphone technologies may markedly reduce alcohol consumption compared with minimal or no intervention controls .
BACKGROUND	Interventions that target non-drinking youth are known to delay the onset of drinking behaviours .
BACKGROUND	Web based alcohol interventions for adolescents also demonstrate significantly greater reductions in consumption and harm among ` high-risk ' drinkers ; however changes in risk status at follow-up for non-drinkers or low-risk drinkers have not been assessed in controlled trials of brief alcohol interventions .
METHODS	The study design comprises two linked randomised controlled trials to evaluate the effectiveness and cost-effectiveness of two intervention strategies compared with screening alone .
METHODS	One trial will focus on high-risk adolescent drinkers attending Emergency Departments ( Eds ) and the other will focus on those identified as low-risk drinkers or abstinent from alcohol but attending the same ED .
METHODS	Our primary ( null ) hypothesis is similar for both trials : Personalised Feedback and Brief Advice ( PFBA ) and Personalised Feedback plus electronic Brief Intervention ( eBI ) are no more effective than screening alone in alcohol consumed at 12 months after randomisation as measured by the Time-Line Follow-Back 28-day version .
METHODS	Our secondary ( null ) hypothesis relating to economics states that PFBA and eBI are no more cost-effective than screening alone .
METHODS	In total 1,500 participants will be recruited into the trials , 750 high-risk drinkers and 750 low-risk drinkers or abstainers .
METHODS	Participants will be randomised with equal probability , stratified by centre , to either a screening only control group or one of the two interventions : single session of PFBA or eBI .
METHODS	All participants will be eligible to receive treatment as usual in addition to any trial intervention .
METHODS	Individual participants will be followed up at 6 and 12 months after randomisation .
CONCLUSIONS	The protocol represents an ambitious innovative programme of work addressing alcohol use in the adolescent population .
BACKGROUND	ISRCTN45300218 .
BACKGROUND	Registered 5th July 2014 .

###24530944
BACKGROUND	Inflammation is associated with progression of chronic heart failure ( HF ) .
BACKGROUND	Few data exist on high-sensitivity C-reactive protein ( hsCRP ) levels and their importance in acute HF .
RESULTS	In this biomarker substudy of the ASCEND-HF trial , we measured hsCRP levels at admission ( n = 794 ) , 48-72 hours ( n = 677 ) , and 30 days ( n = 581 ) and evaluated their association with outcomes .
RESULTS	Levels of hsCRP were considerably elevated at admission ( median 12.6 mg/L , interquartile range [ IQR ] 5.23-30 .5 ) and 48-72 hours ( median 11.0 mg/L , IQR 4.87-29 .9 ) and declined only at 30 days ( median 4.7 mg/L , IQR 1.83-13 .1 ) .
RESULTS	Admission hsCRP was not associated with dyspnea improvement at 6 hours ( 74.1 % ) and 24 hours ( 86.2 % ) , in-hospital death or worsening HF ( n = 37 ; 4.7 % ) , 30-day mortality or HF readmission ( death : n = 25 [ 3.2 % ] ; combined death and HF readmission : n = 95 [ 12.0 % ] ) , or 180-day mortality ( n = 96 ; 12.1 % ) .
RESULTS	Hospital stay ( median 5 days , IQR 3-7 ) was longer among patients with higher admission hsCRP levels ( 0.57 days per log2-hsCRP in adjusted models ; 95 % confidence interval [ CI ] 0.33-0 .81 ; P < .001 ) .
RESULTS	Levels of hsCRP at 48-72 hours did not predict 30-day mortality or HF readmission and were only marginally associated with 180-day mortality .
RESULTS	However , higher hsCRP at 30 days among survivors was associated with higher 180-day mortality in models including admission hsCRP ( adjusted hazard ratio [ HR ] per log2-hsCRP : 1.23 ; 95 % CI 1.04-1 .45 ; P = .016 ) .
RESULTS	Patients with an hsCRP increase at day 30 , defined as > 10 % increase over baseline value , had higher 180-day mortality risk compared with those with unchanged or decreased 30-day hsCRP ( HR 2.29 , 95 % CI 1.16-4 .52 ; P = .017 ) .
CONCLUSIONS	Levels of hsCRP are elevated among patients with acute HF .
CONCLUSIONS	Increasing levels at 30 days after discharge are associated with higher 180-day mortality .

###25000668
OBJECTIVE	To evaluate the clinical effect on plaque metabolism of a dentifrice containing 1.5 % arginine , an insoluble calcium compound and 1,450 ppm fluoride compared to a commercially available dentifrice containing 1,450 ppm fluoride in a silica base .
METHODS	A 12-week , parallel , randomized , double-blind study using 48 subjects was conducted at the Colgate-Palmolive Technology Center ( Piscataway , NJ , USA ) .
METHODS	One group used a test dentifrice containing 1.5 % arginine , an insoluble calcium compound and 1,450 ppm fluoride as sodium monofluorophosphate ( MFP ) , and the other group used a commercial silica dentifrice with 1,450 ppm fluoride as sodium fluoride ( NaF ) as a control .
METHODS	Plaque metabolism analyses were conducted at baseline and after 2 , 4 , 6 , 8 , and 12 weeks of assigned product use .
METHODS	The plaque analyses included pH measurements before and after a sucrose rinse , ammonia production and lactic acid production .
RESULTS	Subjects using the test dentifrice had significantly higher plaque pH values before ( P < or = 0.01 ) and after ( P < or = 0.045 ) a sucrose challenge than those using the commercially available control dentifrice .
RESULTS	Subjects using the test dentifrice also produced higher levels of ammonia and lower levels of lactic acid compared to subjects using the control dentifrice .

###25351610
OBJECTIVE	Current guidelines recommend the use of low molecular weight heparin ( LMWH ) for most haemodynamically stable patients with pulmonary thromboembolism ( PTE ) , however , it is not clear whether LMWH is preferable to unfractionated heparin ( UFH ) for the treatment of massive PTE .
OBJECTIVE	We aimed to compare the use of LMWH versus UFH after thrombolytic treatment in the management of acute massive PTE for hemorrhage and hospital mortality .
METHODS	The study , a randomized , single center , parallel design trial , included the patients who had confirmed the diagnosis of massive PTE according to clinical findings and computerized thorax angiography and no contraindication to the treatment between January 2011 and October 2013 .
METHODS	After thrombolytic treatment , the patients assigned to therapy with LMWH or UFH .
METHODS	Any hemorrhage , major hemorrhage , and hospital mortality were assessed .
RESULTS	A total of 121 patients , 71 female ( 58.7 % ) and 50 male ( 41.3 % ) , who had massive PTE with an average age 62.6 15.7 ( ranges 22-87 ) were included for analyses in the study .
RESULTS	They were allocated to either LMWH ( n = 60 ) or UFH ( n = 61 ) group .
RESULTS	Although the occurrence of any adverse event ( 21.7 vs 27.9 % ) and each individual type of adverse event were all lower in the LMWH group compared to UFH group ( 6.7 vs 11.5 % , 3.3 vs 9.8 % , and 15.0 vs 19.7 % for death , major hemorrhage , and any hemorrhage , respectively ) , the differences were not statistically significant .
CONCLUSIONS	Our findings suggest that LMWH might be a better option in the management of the patients with massive PTE .
CONCLUSIONS	Multi-center larger randomized controlled trials are required to confirm our results .

###25437217
BACKGROUND	The CALORIES trial is a pragmatic , open , multicentre , randomised controlled trial ( RCT ) of the clinical effectiveness and cost-effectiveness of early nutritional support via the parenteral route compared with early nutritional support via the enteral route in unplanned admissions to adult general critical care units ( CCUs ) in the United Kingdom .
BACKGROUND	The trial derives from the need for a large , pragmatic RCT to determine the optimal route of delivery for early nutritional support in the critically ill .
OBJECTIVE	To describe the proposed statistical analyses for the evaluation of the clinical effectiveness in the CALORIES trial .
METHODS	With the primary and secondary outcomes defined precisely and the approach to safety monitoring and data collection summarised , the planned statistical analyses , including prespecified subgroups and secondary analyses , were developed and are described .
RESULTS	The primary outcome is all-cause mortality at 30 days .
RESULTS	The primary analysis will be reported as a relative risk and absolute risk reduction and tested with the Fisher exact test .
RESULTS	Prespecified subgroup analyses will be based on age , degree of malnutrition , acute severity of illness , mechanical ventilation at admission to the CCU , presence of cancer and time from CCU admission to commencement of early nutritional support .
RESULTS	Secondary analyses include adjustment for baseline covariates .
CONCLUSIONS	In keeping with best trial practice , we have developed , described and published a statistical analysis plan for the CALORIES trial and are placing it in the public domain before inspecting data from the trial .

###26002986
OBJECTIVE	To compare different techniques of minimally invasive surgery ( laparoscopy and robotics ) to abdominal surgery in order to identify the optimal surgical technique in the treatment of endometrial cancer .
METHODS	A single-institutional , matched , retrospective , cohort study was performed .
METHODS	All patients with clinical stage I or occult stage II endometrial cancer who underwent robotic hysterectomy , bilateral salpingo-oophorectomy lymphadenectomy from August 2010 and December 2013 were identified .
METHODS	Surgical and oncological outcomes were compared with patients matched by age , body mass index , tumor histology , and grade , who underwent abdominal or laparoscopic surgery between January 2001 and December 2013 .
RESULTS	Three groups were identified : 177 laparotomies ( group A ) , 277 laparoscopies ( group B ) and 72 robotics ( group C ) .
RESULTS	There were no statistically significant differences between the three groups in terms of age , BMI and FIGO stage .
RESULTS	The operative time was shortest in group B ( p = 0.0001 ) .
RESULTS	Blood loss and transfusions were equivalent in group B and C , while they were greater in group A ( p = 0.0001 ) .
RESULTS	The intra-operative , early and late postoperative complications , rate of conversion , the re-intervention and median hospital stay were lower in group C.
RESULTS	The rate of recurrence and death from disease was similar in all three groups .
CONCLUSIONS	Minimally invasive surgery was superior to abdominal surgery in terms of surgical outcomes .
CONCLUSIONS	Robotic surgery was superior to laparoscopy in terms of intra - and post-operative complications , conversion rates , length of hospital stay and re-interventions .
CONCLUSIONS	In terms of oncological outcomes the three groups were equivalent .

###25145781
OBJECTIVE	Tacrolimus is an effective ( but relatively expensive ) immunosuppressant that is used widely in patients with membranous nephropathy .
OBJECTIVE	To reduce the tacrolimus dose while maintaining an equivalent therapeutic effect , we studied the clinical efficacy and pharmacoeconomic impact of co-administration of Wuzhi capsules ( WZC that protects against damage to liver cells ) and tacrolimus .
METHODS	Sixty patients with membranous nephropathy were divided randomly into two groups : experimental ( tacrolimus + WZC + corticosteroids ) and control ( tacrolimus + corticosteroids ) .
METHODS	Each group received treatments continuously for > 6 months .
METHODS	Liver function ; renal function ; and whole-blood concentrations of tacrolimus , sugars , lipids , as well as 24-h urinary protein levels were used in the clinical evaluation .
METHODS	The cost of drugs was calculated , and the pharmacoeconomic cost-effectiveness analyses were carried out to compare indices between the two groups .
RESULTS	Doses and costs of tacrolimus differed significantly between experimental and control groups ( p < 0.01 or p < 0.05 ) .
RESULTS	Costs in the experimental group were 13,702.62 1,458.6 CNY ( 2,194.10 233.56 USD ) and those in the control group were 17,796.87 2,469.27 CNY ( 2,849.69 395.39 USD ) , with clinical efficacy of 93.3 and 90.0 % , respectively .
RESULTS	The cost-effectiveness ratios were 146.86 15.63 and 197.73 27.44 , respectively .
RESULTS	Compared with the experimental group , the control group showed an incremental cost-effectiveness ratio of 1,240.68 306.25 CNY ( 198.66 49.04 USD ) , whereas remission between the two groups was similar .
CONCLUSIONS	Co-administration of WZCs and tacrolimus can reduce the dose of tacrolimus and decrease the costs incurred by patients within the same therapeutic window to that seen for treatment with tacrolimus alone .

###25584004
OBJECTIVE	This phase III trial aimed to confirm the superiority of weekly docetaxel and cisplatin over docetaxel monotherapy in elderly patients with advanced non-small-cell lung cancer ( NSCLC ) .
METHODS	Chemotherapy-nave patients with stage III , stage IV , or recurrent NSCLC age 70 years with a performance status of 0 or 1 who were considered unsuitable for bolus cisplatin administration were randomly assigned to receive docetaxel 60 mg/m ( 2 ) on day 1 , every 3 weeks , or docetaxel 20 mg/m ( 2 ) plus cisplatin 25 mg/m ( 2 ) on days 1 , 8 , and 15 , every 4 weeks .
METHODS	The primary end point was overall survival ( OS ) .
RESULTS	In the first interim analysis , OS of the doublet arm was inferior to that of the monotherapy arm ( hazard ratio [ HR ] , 1.56 ; 95 % CI , 0.98 to 2.49 ) , and the predictive probability that the doublet arm would be statistically superior to the monotherapy arm on final analysis was 0.996 % , which led to early study termination .
RESULTS	In total , 276 patients with a median age of 76 years ( range , 70 to 87 years ) were enrolled .
RESULTS	At the updated analysis , the median survival time was 14.8 months for the monotherapy arm and 13.3 months for the doublet arm ( HR , 1.18 ; 95 % CI , 0.83 to 1.69 ) .
RESULTS	The rates of grade 3 neutropenia and febrile neutropenia were higher in the monotherapy arm , and those of anorexia and hyponatremia were higher in the doublet arm .
CONCLUSIONS	This study failed to demonstrate any survival advantage of weekly docetaxel plus cisplatin over docetaxel monotherapy as first-line chemotherapy for advanced NSCLC in elderly patients .

###25762809
BACKGROUND	Active video games ( AVGs ) have been shown to acutely increase energy expenditure when compared with seated video games ; however , the influence of AVGs on compensatory adjustments in energy intake and expenditure is largely unknown .
OBJECTIVE	The aim was to examine the acute effects of AVGs on energy intake and expenditure .
METHODS	With the use of a randomized crossover design , 26 male adolescents ( mean SD age : 14.5 1.4 y ) completed three 1-h experimental conditions : resting control , seated video game play ( Xbox 360 ; Microsoft ) , and AVG play ( Kinect Adventures on Xbox 360 ) followed by an ad libitum lunch .
METHODS	A validated food menu was used to assess food intake immediately after the conditions and for the remainder of the day , and a dietary record was used for the subsequent 3-d period .
METHODS	Energy expenditure was measured by using portable indirect calorimetry throughout each experimental condition , and an accelerometer was used to assess the subsequent 3-d period .
METHODS	Appetite sensations were assessed by using visual analog scales at different time points during the testing day .
METHODS	The primary outcomes were acute ( immediately after the conditions and 24-h ) and short-term ( 3-d ) energy intake and expenditure .
RESULTS	Energy expenditure was significantly higher ( ~ 145 % ; P < 0.001 ) during the AVG condition than during the resting control and seated video game conditions ; however , no significant differences in energy expenditure were observed 24 h ( ~ 6 % ; P > 0.49 ) and 3 d after the experimental conditions ( ~ 3 % ; P > 0.82 ) .
RESULTS	No significant differences were observed in absolute energy intake immediately after the conditions ( ~ 2 % ; P > 0.94 ) or in absolute energy intake 24 h ( ~ 5 % ; P > 0.63 ) and 3 d ( ~ 9 % ; P > 0.53 ) after the experimental conditions .
RESULTS	Finally , appetite sensations were similar between conditions at all time points ( P > 0.05 ) .
CONCLUSIONS	The increase in energy expenditure promoted by a single session of Kinect AVG play is not associated with increased food intake but is compensated for after the intervention , resulting in no measurable change in energy balance after 24 h.
CONCLUSIONS	These results suggest that the potential of Kinect to reduce the energy gap underlying weight gain is offset within 24 h in male adolescents .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01655901 .

###24831977
BACKGROUND	Ipilimumab is a fully human monoclonal antibody that binds cytotoxic T-lymphocyte antigen 4 to enhance antitumour immunity .
BACKGROUND	Our aim was to assess the use of ipilimumab after radiotherapy in patients with metastatic castration-resistant prostate cancer that progressed after docetaxel chemotherapy .
METHODS	We did a multicentre , randomised , double-blind , phase 3 trial in which men with at least one bone metastasis from castration-resistant prostate cancer that had progressed after docetaxel treatment were randomly assigned in a 1:1 ratio to receive bone-directed radiotherapy ( 8 Gy in one fraction ) followed by either ipilimumab 10 mg/kg or placebo every 3 weeks for up to four doses .
METHODS	Non-progressing patients could continue to receive ipilimumab at 10 mg/kg or placebo as maintenance therapy every 3 months until disease progression , unacceptable toxic effect , or death .
METHODS	Patients were randomly assigned to either treatment group via a minimisation algorithm , and stratified by Eastern Cooperative Oncology Group performance status , alkaline phosphatase concentration , haemoglobin concentration , and investigator site .
METHODS	Patients and investigators were masked to treatment allocation .
METHODS	The primary endpoint was overall survival , assessed in the intention-to-treat population .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00861614 .
RESULTS	From May 26 , 2009 , to Feb 15 , 2012 , 799 patients were randomly assigned ( 399 to ipilimumab and 400 to placebo ) , all of whom were included in the intention-to-treat analysis .
RESULTS	Median overall survival was 112 months ( 95 % CI 95-127 ) with ipilimumab and 100 months ( 83-110 ) with placebo ( hazard ratio [ HR ] 085 , 072-100 ; p = 0053 ) .
RESULTS	However , the assessment of the proportional hazards assumption showed that it was violated ( p = 00031 ) .
RESULTS	A piecewise hazard model showed that the HR changed over time : the HR for 0-5 months was 146 ( 95 % CI 110-195 ) , for 5-12 months was 065 ( 050-085 ) , and beyond 12 months was 060 ( 043-086 ) .
RESULTS	The most common grade 3-4 adverse events were immune-related , occurring in 101 ( 26 % ) patients in the ipilimumab group and 11 ( 3 % ) of patients in the placebo group .
RESULTS	The most frequent grade 3-4 adverse events included diarrhoea ( 64 [ 16 % ] of 393 patients in the ipilimumab group vs seven [ 2 % ] of 396 in the placebo group ) , fatigue ( 40 [ 11 % ] vs 35 [ 9 % ] ) , anaemia ( 40 [ 10 % ] vs 43 [ 11 % ] ) , and colitis ( 18 [ 5 % ] vs 0 ) .
RESULTS	Four ( 1 % ) deaths occurred because of toxic effects of the study drug , all in the ipilimumab group .
CONCLUSIONS	Although there was no significant difference between the ipilimumab group and the placebo group in terms of overall survival in the primary analysis , there were signs of activity with the drug that warrant further investigation .
BACKGROUND	Bristol-Myers Squibb .

###25192498
BACKGROUND	Dersalazine sodium is an inhibitor of platelet activator factor with potential efficacy in patients with ulcerative colitis through an alternative mechanism of action .
BACKGROUND	The study was a first proof of clinical safety and activity of dersalazine sodium in patients with ulcerative colitis .
METHODS	A double-blind study of randomized patients with ulcerative colitis ( Mayo score 5 and 10 , including a sigmoidoscopy subscore 2 ) to dersalazine sodium 1200 mg/12 h , mesalazine 1200 mg/12 h , or placebo for 4 weeks .
METHODS	Mayo scores were calculated on week 2 ( partial Mayo ) and week 4 ( full Mayo ) .
METHODS	All patients received open-label mesalazine for 4 additional weeks , and a final visit was done at week 8 .
RESULTS	The study included 34 patients ( 13 dersalazine sodium , 10 mesalazine , and 11 placebo ) .
RESULTS	Clinical remission was observed in 46.2 % patients treated with dersalazine sodium versus 12.5 % in mesalazine and 10 % in placebo after 4 weeks of treatment .
RESULTS	Colon biopsies showed significantly decreased expression of inflammatory genes in dersalazine sodium patients .
RESULTS	Adverse events at least possibly related to treatment were observed in 23 % , 12.5 % , and 7.6 % of patients receiving dersalazine sodium , mesalazine , and placebo , respectively ; no serious adverse reactions were reported .
RESULTS	Increased liver enzymes were reported in 2/13 patients receiving dersalazine sodium , with normal bilirubin levels ; both returned to normal values on treatment interruption .
CONCLUSIONS	Studies in wider populations are needed to confirm the clinical activity of dersalazine sodium .
CONCLUSIONS	Weekly measurements of liver function tests may be necessary for early detection of adverse events .

###24313244
OBJECTIVE	This study tested the hypothesis that the antidepressant venlafaxine would be an effective treatment for cocaine abusers with concurrent depressive disorders .
METHODS	This was a randomized , 12-week , double-blind , placebo-controlled trial of outpatients ( N = 130 ) meeting DSM-IIIR criteria for cocaine dependence and major depression or dysthymia ( by SCID interview ) .
METHODS	Participants were treated with venlafaxine , up to 300mg/day versus placebo .
METHODS	All patients received weekly individual manual-guided relapse prevention therapy .
METHODS	Weekly outcome measures included Clinical Global Impression Scale ( CGI ) , self-reported cocaine use , urine toxicology and the Hamilton Depression Scale ( Ham-D ) .
RESULTS	Mood response , defined as a 50 % reduction in the Ham-D between randomization and end of study , was 41 % ( 26/64 ) on venlafaxine , and 33 % ( 22/66 ) on placebo ( p = .39 ) .
RESULTS	Measures of depression ( Ham-D and CGI ) improved more rapidly on venlafaxine than placebo , but these differences disappeared by weeks 6-8 .
RESULTS	Cocaine outcomes did not differ between treatment groups , and the proportion of patients achieving three or more consecutive weeks of urine-confirmed abstinence was low ( venlafaxine : 16 % ; placebo : 15 % ) .
RESULTS	Reduction in cocaine use was associated with mood response .
CONCLUSIONS	Overall , venlafaxine was not superior to placebo on either mood or cocaine use outcomes .
CONCLUSIONS	Mood improvement was associated with improvement in cocaine use .
CONCLUSIONS	However , placebo mood response was only moderate , and the proportion of patients achieving sustained abstinence was low .
CONCLUSIONS	This suggests that the subgroup of cocaine-dependent patients with depressive disorders is relatively treatment resistant , and that further research is needed to improve outcomes for these patients .

###25308884
OBJECTIVE	To investigate the feasibility and preliminary outcomes of a home progressive resistance training ( PRT ) program augmented by neuromuscular electrical stimulation ( NMES ) .
METHODS	Randomized controlled pilot trial .
METHODS	Participant homes .
METHODS	People with multiple sclerosis ( MS ) ( N = 37 ) who use a walking aid .
METHODS	A 12-week home PRT program or the same program augmented by NMES .
METHODS	Strength using hand-held dynamometry ; repeated sit to stand test ; Berg Balance Scale ; timed Up & Go test ; 12-Item Multiple Sclerosis Walking Scale ; Multiple Sclerosis Impact Scale-29 , version 2 ; and Modified Fatigue Impact Scale ( MFIS ) .
METHODS	The NMES group also completed a device usability questionnaire .
RESULTS	Only change in MFIS score was significantly greater in the NMES group than the PRT group ( P = .012 ) .
RESULTS	The NMES group improved significantly in quadriceps endurance ( median of change , 8.5 ; P = .043 ) , balance ( median of change , 3.5 ; P = .001 ) , physical impact of MS ( median of change , -8.3 ; P = .001 ) , and impact of fatigue ( median of change , -17 ; P = .001 ) .
RESULTS	Participants rated the device as highly usable .
CONCLUSIONS	This pilot study suggests that a home PRT program with NMES is feasible , and the neuromuscular electrical stimulation device is usable by this population .
CONCLUSIONS	Only reduction in impact of fatigue was greater in the NMES than the PRT group .

###24877089
BACKGROUND	Plantarflexion results from the combined action of the soleus and gastrocnemius muscles in the calf .
BACKGROUND	The heel rise test is commonly used to test calf muscle endurance , function , and performance by a wide variety of professionals ; however , no uniform description of the test is available .
BACKGROUND	This paper aims to document the construction and reliability of a novel heel rise test device and measurement protocol that is suitable for the needs of most individuals .
METHODS	This device was constructed from compact and lightweight materials and is fully adjustable , enabling the testing of a wide variety of individuals .
METHODS	It is easy to assemble and disassemble , ensuring that it is portable for use in different settings .
RESULTS	We tested reliability on 40 participants , finding excellent interrater reliability ( ICC2 ,1 0.97 , 95 % CI : 0.94 to 0.98 ) .
RESULTS	Limits of agreement were less than two repetitions in 90 % of cases and the Bland-Altman plot showed no bias .
CONCLUSIONS	We have designed a novel , standardized , simple , and reliable device and measurement protocol for the heel rise test which can be used by researchers and clinicians in a variety of settings .

###24281730
BACKGROUND	Because antileukotrienes may inhibit inflammation , it is plausible that montelukast administered for a long time could suppress skin wheal and flare reaction , and thus , it should be discarded prior to the tests .
BACKGROUND	This study assessed the effect of long-lasting treatment with montelukast alone or in combination with antihistamines on wheal and flare in skin pricks tests ( SPT ) in patients sensitized to perennial allergens .
METHODS	We conducted a 32-week , double-blind , placebo-controlled , cross-over and randomized trial that implicated two arms : arm A , 20 patients received levocetirizine , montelukast with or without levocetirizine or placebo ; arm B , 20 patients received desloratadine , montelukast with or without desloratadine or placebo .
METHODS	All treatment periods lasted 6weeks and were separated by 2-week washouts .
METHODS	At baseline and on the last day of each treatment period , SPT were performed in all participants .
RESULTS	Both levocetirizine and desloratadine in monotherapy , or in combination with montelukast , were effective in reducing wheal and flare in SPT .
RESULTS	Monotherapy with montelukast did not change the size of the wheal for either histamine or for house dust mites , in either arm of the study , but significantly reduced the size of flare for histamine in arm A. Addition of montelukast to antihistamine did not exceed efficacy of monotherapy with antihistamine in both arms of the study .
CONCLUSIONS	Since the size of wheal determines the results of SPT , montelukast , even taken for a long time , does not have to be discarded prior to the tests .

###24368613
OBJECTIVE	The objective of this study was to compare image quality ( objective and subjective parameters ) and confidence in lesion detection between 3 image reconstruction algorithms in computed tomographic ( CT ) examinations of the abdomen/pelvis .
METHODS	This prospective institutional review board-approved study included 65 patients ( mean [ SD ] age , 71.3 9 years ; mean [ SD ] body mass index , 24.4 [ 4.8 ] kg ) who underwent routine CT examinations of the abdomen/pelvis followed immediately by 2 low-dose scans .
METHODS	Raw data sets were reconstructed by using filtered back projection ( FBP ) , adaptive statistical iterative reconstruction ( ASIR ) , and a model-based iterative reconstruction ( MBIR ) .
METHODS	Measurements of objective noise and CT numbers were compared using repeated-measures analysis of variance .
METHODS	Six subjective image quality parameters were scored .
METHODS	Diagnostic confidence and accuracy in detection of various elementary lesions were performed .
RESULTS	Objectively , mean image noise for MBIR was significantly superior at all dose levels ( P < 0.001 ) .
RESULTS	Subjectively , standard-dose ASIR and low-dose MBIR scans were better than standard-dose FBP scan in all parameters assessed ( P < 0.05 ) .
RESULTS	Low-dose MBIR scans were comparable with standard-dose ASIR scans in all parameters except at noise index of 70 ( approximately 85 % dose reduction ) , where , in this case , the detection of liver lesions less than 5 mm were rated inferior ( P < 0.05 ) with diagnostic accuracy reducing to 77.4 % .
CONCLUSIONS	Low-dose MBIR scan shows superior objective noise reduction compared with standard-dose FBP and ASIR .
CONCLUSIONS	Subjectively , low-dose MBIR scans at 76 % dose reduction were also superior compared with standard-dose FBP and ASIR .
CONCLUSIONS	However , at dose reductions of 85 % , small liver lesions may be missed .

###25387256
BACKGROUND	Ultrasound-guided radiofrequency ablation ( RFA ) of solid thyroid nodules ( TNs ) is a minimally invasive procedure that may induce a volume reduction of symptomatic solid benign TNs .
OBJECTIVE	The aim of the study was to evaluate the effectiveness and safety of RFA in debulking benign TNs .
METHODS	Eighty-four consecutive patients with symptomatic and cytologically benign solid nodules were randomly assigned to either a single RFA session ( group A ; n = 42 ) or follow-up ( group B ; n = 42 ) at our center .
METHODS	Entry criteria were a solid thyroid nodule or predominantly solid ( with a fluid component 30 % of the volume ) , normal thyroid function , no autoimmunity , and no previous thyroid gland treatment .
METHODS	Three subgroups were formed according to the baseline volume of nodules : small ( 12 mL ) , medium ( from 12 to 30 mL ) , or large ( > 30 mL ) .
METHODS	In group A RFA was performed in a single session with the moving-shot technique .
METHODS	Volume and local symptom changes were evaluated 1 and 6 months after RFA .
RESULTS	In group A , the volume decreased from 24.5.5 19.6 to 8.6 9.5 6 months after RFA ( P = .001 ) .
RESULTS	The greatest volume reduction was in small nodules .
RESULTS	The pressure symptom score improved only in medium and large nodules ( P < .001 ) , whereas the cosmetic score improved in all treated patients ( P < .001 ) .
RESULTS	The rate of thyroid volumetric reduction was not statistically different between solid and predominantly solid nodules .
RESULTS	Only one patient experienced permanent right paramedian vocal cord palsy with inspiratory stridor without dysphonia .
RESULTS	In group B , nodule volume remained unchanged , whereas the symptom score was worse at the 6-month evaluation ( P = .01 ) .
CONCLUSIONS	RFA is effective in reducing thyroid nodule volume .
CONCLUSIONS	The best reduction rate was observed in small TNs .
CONCLUSIONS	The thyroid volumetric reduction does not change according to the sonographic features .
CONCLUSIONS	The mean treatment duration was longer in larger TNs .

###25575085
METHODS	Prospective randomized controlled trial .
OBJECTIVE	The aim of this study was to monitor the quality control of robot-assisted pedicle screw fixation accuracy by using a cumulative summation ( CUSUM ) test at the initial stage of its application .
BACKGROUND	Although robot-assisted pedicle screw fixation reduces screw misplacement rates and provides critical support for minimally invasive surgical procedures , there have been no reports relating to the monitoring of quality control of the accuracy of this robot-assisted pedicle screw fixation procedure .
METHODS	Patients with lumbar spinal stenosis scheduled to undergo surgery were randomly and equally assigned through 1:1 allocation to a robot-assisted minimally invasive posterior lumbar interbody fusion ( Rom-PLIF ) group or a conventional open posterior PLIF using freehand technique group .
METHODS	The accuracy of pedicle screw placement was evaluated using postoperative computed tomography .
METHODS	The primary outcome was the CUSUM analysis for monitoring the quality control of the accuracy of pedicle screw insertion between the Rom-PLIF and conventional open posterior PLIF using freehand technique groups .
RESULTS	Of the 80 pedicle screws inserted in each group , 4 screws in the Rom-PLIF group , and 7 in the conventional open PLIF group , breached the pedicle .
RESULTS	Of these 11 offending screws , 4 cases were categorized as grade B in the Rom-PLIF group , whereas 6 were grade B and 1 case was grade C in the Com-PLIF group , using the Gertzbein and Robbins classification .
RESULTS	Throughout the monitoring period , there was no CUSUM test-derived indication that the quality of performance of the pedicle screw fixation procedure was inadequate in either group .
CONCLUSIONS	First , this study demonstrates the adequacy of quality control of robot-assisted pedicle screw fixation even early in the application period based on the CUSUM analysis .
CONCLUSIONS	Second , the CUSUM test can be a useful tool for monitoring of the quality of procedures related with spine surgery .

###24500537
OBJECTIVE	Gait retraining , comprising biofeedback and/or an exercise intervention , might reduce the risk of musculoskeletal conditions .
OBJECTIVE	The purpose was to examine the effect of a gait-retraining program on medial tibial stress syndrome incidence during a 26-wk basic military training regimen .
METHODS	A total of 450 British Army recruits volunteered .
METHODS	On the basis of a baseline plantar pressure variable ( mean foot balance during the first 10 % of stance ) , participants classified as at risk of developing medial tibial stress syndrome ( n = 166 ) were randomly allocated to an intervention ( n = 83 ) or control ( n = 83 ) group .
METHODS	The intervention involved supervised gait retraining , including exercises to increase neuromuscular control and flexibility ( three sessions per week ) and biofeedback enabling internalization of the foot balance variable ( one session per week ) .
METHODS	Both groups continued with the usual military training regimen .
METHODS	Diagnoses of medial tibial stress syndrome over the 26-wk regimen were made by physicians blinded to the group assignment .
METHODS	Data were modeled in a survival analysis using Cox regression , adjusting for baseline foot balance and time to peak heel rotation .
RESULTS	The intervention was associated with a substantially reduced instantaneous relative risk of medial tibial stress syndrome versus control , with an adjusted HR of 0.25 ( 95 % confidence interval , 0.05-0 .53 ) .
RESULTS	The number needed to treat to observe one additional injury-free recruit in intervention versus control at 20 wk was 14 ( 11 to 23 ) participants .
RESULTS	Baseline foot balance was a nonspecific predictor of injury , with an HR per 2 SD increment of 5.2 ( 1.6 to 53.6 ) .
CONCLUSIONS	The intervention was effective in reducing incidence of medial tibial stress syndrome in an at-risk military sample .

###25171666
OBJECTIVE	The aim of this study was to determine the efficacy of electrical stimulation when added to conventional physical therapy with regard to clinical and neurophysiologic changes in patients with Bell palsy .
METHODS	This was a randomized controlled trial .
METHODS	Sixty patients diagnosed with Bell palsy ( 39 right sided , 21 left sided ) were included in the study .
METHODS	Patients were randomly divided into two therapy groups .
METHODS	Group 1 received physical therapy applying hot pack , facial expression exercises , and massage to the facial muscles , whereas group 2 received electrical stimulation treatment in addition to the physical therapy , 5 days per week for a period of 3 wks .
METHODS	Patients were evaluated clinically and electrophysiologically before treatment ( at the fourth week of the palsy ) and again 3 mos later .
METHODS	Outcome measures included the House-Brackmann scale and Facial Disability Index scores , as well as facial nerve latencies and amplitudes of compound muscle action potentials derived from the frontalis and orbicularis oris muscles .
RESULTS	Twenty-nine men ( 48.3 % ) and 31 women ( 51.7 % ) with Bell palsy were included in the study .
RESULTS	In group 1 , 16 ( 57.1 % ) patients had no axonal degeneration and 12 ( 42.9 % ) had axonal degeneration , compared with 17 ( 53.1 % ) and 15 ( 46.9 % ) patients in group 2 , respectively .
RESULTS	The baseline House-Brackmann and Facial Disability Index scores were similar between the groups .
RESULTS	At 3 mos after onset , the Facial Disability Index scores were improved similarly in both groups .
RESULTS	The classification of patients according to House-Brackmann scale revealed greater improvement in group 2 than in group 1 .
RESULTS	The mean motor nerve latencies and compound muscle action potential amplitudes of both facial muscles were statistically shorter in group 2 , whereas only the mean motor latency of the frontalis muscle decreased in group 1 .
CONCLUSIONS	The addition of 3 wks of daily electrical stimulation shortly after facial palsy onset ( 4 wks ) , improved functional facial movements and electrophysiologic outcome measures at the 3-mo follow-up in patients with Bell palsy .
CONCLUSIONS	Further research focused on determining the most effective dosage and length of intervention with electrical stimulation is warranted .

###24331798
OBJECTIVE	To evaluate the efficacy and safety of tirofiban use immediately after successful percutaneous coronary intervention ( PCI ) in patients with moderate to high risk non-ST segment elevation acute coronary syndromes ( NSTE-ACS ) .
METHODS	NSTE-ACS patients undergoing successful PCI ( n = 246 ) were randomized by the envelope method to tirofiban group ( n = 122 , 10 g/kg bolus within 3 min followed by 0.10-0 .15 gkg ( -1 ) min ( -1 ) for 36 h i.v. ) or control group ( n = 124 , saline i.v. for 36 h ) .
METHODS	The primary efficacy composite end point was death , myocardial infarction , target vascular revascularization or ischemic stroke at 30 days .
METHODS	The second end point was the occurrence of composite end point at 7 days or 6 months .
METHODS	Key safety end points were bleeding and thrombocytopenia 3 days after PCI .
RESULTS	Baseline characteristics were well-balanced between the two groups ( P > 0.05 ) .
RESULTS	The primary end point occurred in 0.9 % ( 1/117 ) patients in the tirofiban group and 3.3 % ( 4/123 ) patients of those in the control group ( P = 0.40 ) .
RESULTS	There was no significant difference in the composite end point at 7 days [ 0.8 % ( 1/122 ) vs. 3.2 % ( 4/124 ) , P = 0.38 ] between the groups , however , there was a trend towards lower composite efficacy end points at 6 months in tirofiban group compared to control group [ 0.9 % ( 1/117 ) vs. 5.9 % ( 7/118 ) , P = 0.07 ] .
RESULTS	The probability of survival free of composite end point was significantly higher in the tirofiban group than that in the control group ( 99.2 % vs. 94.2 % , log-rank test , P = 0.03 ) .
RESULTS	There was no GUSTO severe or moderate bleeding or severe thrombocytopenia within 3 days post-PCI .
RESULTS	There was no significant difference in mild bleeding [ 13.1 % ( 16/122 ) vs. 7.3 % ( 9/124 ) , P = 0.13 ] or mild thrombocytopenia [ 0.8 % ( 1/122 ) vs. 0.8 % ( 1/124 ) , P = 1.00 ] between the groups .
CONCLUSIONS	Tirofiban use after successful PCI can improve 6-month event-free survival without increasing the risk of bleeding for patients with moderate to high risk NSTE-ACS .

###24361804
BACKGROUND	There are no data regarding the effect of weight loss on clinical outcomes in patients undergoing cardiac resynchronization therapy .
BACKGROUND	This study was designed to evaluate the effect of weight loss on clinical outcomes in patients implanted with a cardiac resynchronization therapy with defibrillator ( CRT-D ) .
RESULTS	The risk of heart failure ( HF ) or death , and of death alone , was compared between patients with and without weight loss of 2 kg or more at 1 year in the CRT-D arm of the Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy ( MADIT-CRT ) .
RESULTS	Weight loss was observed in 170 of 994 patients ( 17 % ) implanted with a CRT-D .
RESULTS	Multivariate analysis showed a significant increase in the risk of HF or death among patients with weight loss compared with those without weight loss ( hazard ratio [ HR ] 1.82 , 95 % confidence interval [ CI ] 1.26-2 .63 ; P = .001 ) .
RESULTS	Weight loss was associated with a 79 % increase in the risk of all-cause mortality ( HR 1.79 , 95 % CI 1.16-3 .34 ; P = .01 ) .
RESULTS	When analyzed in a continuous fashion , each kg of weight loss was associated with a 4 % increase in the risk of HF or death ( P = .03 ) .
RESULTS	In left bundle branch block ( LBBB ) patients with a CRT-D , weight loss was associated with an especially high risk of HF or death ( HR 2.23 , 95 % CI 1.36-3 .65 ; P = .002 ) and of death alone ( HR 2.33 , 95 % CI 1.07-5 .06 ; P = .03 ; interaction P = .26 ) .
CONCLUSIONS	In patients with mild symptoms of HF receiving CRT-D , weight loss observed at 1 year is associated with adverse clinical outcomes , especially in those with a LBBB electrocardiographic pattern .

###25493978
BACKGROUND	Progesterone has been associated with robust positive effects in animal models of traumatic brain injury ( TBI ) and with clinical benefits in two phase 2 randomized , controlled trials .
BACKGROUND	We investigated the efficacy and safety of progesterone in a large , prospective , phase 3 randomized clinical trial .
METHODS	We conducted a multinational placebo-controlled trial , in which 1195 patients , 16 to 70 years of age , with severe TBI ( Glasgow Coma Scale score , 8 [ on a scale of 3 to 15 , with lower scores indicating a reduced level of consciousness ] and at least one reactive pupil ) were randomly assigned to receive progesterone or placebo .
METHODS	Dosing began within 8 hours after injury and continued for 120 hours .
METHODS	The primary efficacy end point was the Glasgow Outcome Scale score at 6 months after the injury .
RESULTS	Proportional-odds analysis with covariate adjustment showed no treatment effect of progesterone as compared with placebo ( odds ratio , 0.96 ; confidence interval , 0.77 to 1.18 ) .
RESULTS	The proportion of patients with a favorable outcome on the Glasgow Outcome Scale ( good recovery or moderate disability ) was 50.4 % with progesterone , as compared with 50.5 % with placebo .
RESULTS	Mortality was similar in the two groups .
RESULTS	No relevant safety differences were noted between progesterone and placebo .
CONCLUSIONS	Primary and secondary efficacy analyses showed no clinical benefit of progesterone in patients with severe TBI .
CONCLUSIONS	These data stand in contrast to the robust preclinical data and results of early single-center trials that provided the impetus to initiate phase 3 trials .
CONCLUSIONS	( Funded by BHR Pharma ; SYNAPSE ClinicalTrials.gov number , NCT01143064 . )

###25566615
OBJECTIVE	To observe the effect of Kuntai Capsule ( KC ) , a Chinese patent medicine , in add-back therapy for gonadotropin-releasing hormone agonist ( GnRH-a ) treatment for moderate-severe endometriosis ( EM ) .
METHODS	Totally 100 patients suffering from stage III/IV EM , who were confirmed by laparoscopic surgery were randomly assigned to the GnRH-a group ( A ) and the KC combined GnRH-a group ( B ) , 50 in each group .
METHODS	Patients in Group A were hypodermically injected with goserelin ( 3.6 mg ) , once per 4 weeks .
METHODS	Those in Group B additionally took KC , 4 pills each time , three times per day .
METHODS	The therapeutic course for all was 12 weeks .
METHODS	Serum levels of estradiol ( E2 ) , follicle stimulating hormone ( FSH ) , bone gamma-carboxyglutamic-acid-containing proteins ( BGP ) were measured respectively .
METHODS	Kupperman Menopausal Index ( KMI ) and bone mineral density ( BMD ) of the lumbar vertebra were also compared between the two groups .
RESULTS	Serum levels of E2 and FSH both significantly decreased in the two groups at week 12 of the treatment ( P < 0.05 ) , when compared with pre-treatment .
RESULTS	Compared with before treatment in the same group , KMI increased in the two groups ( P < 0.05 ) .
RESULTS	Compared with before treatment in the same group , BMI decreased in the two groups with no statistical difference ( P > 0.05 ) .
RESULTS	Serum BGP increased after 12-week treatment ( P < 0.05 ) .
RESULTS	Compared with Group A after treatment , serum levels of E2 and FSH both significantly increased in Group B ( P < 0.05 ) .
RESULTS	There was no statistical difference in KMI between the two groups ( P > 0.05 ) .
RESULTS	As for the incidence of menopausal symptoms , better effects in improving symptoms such as hot flashes , sleep disorders , and vaginal dryness were obtained in Group B than in Group A ( P < 0.05 ) .
RESULTS	There was no significant difference in the post-pre-treatment difference of BMI between the two groups , but with statistical post-pre-treatment difference in the BGP level ( P < 0.05 ) .
CONCLUSIONS	HKC combined GnRH-a could effectively reduce GnRH-a treatment induced partial low estrogen symptoms , improve increased serum BGP levels after GnRH-a therapy .

###25164709
OBJECTIVE	To compare the frequency of achieving a therapeutic serum digoxin concentration ( SDC ) , defined as 0.5-0 .9 ng/ml , by using a simplified nomogram to individualize digoxin dosing with standard dosing practices in patients with heart failure , and to characterize the relationship between genetic polymorphisms of the ABCB1 gene and SDC .
METHODS	Prospective study with a historical control group .
METHODS	Outpatient care center of an urban academic medical center .
METHODS	A total of 131 adults with heart failure due to left ventricular dysfunction who were treated with digoxin .
METHODS	Digoxin doses were determined either by the dosing nomogram ( 65 patients ) or standard care ( SC ; 66 patients ) by using historical controls who were randomly selected from a list of SDCs obtained from laboratory records and who had their digoxin doses determined by standard dosing practices .
RESULTS	The primary end point was the proportion of patients achieving a steady-state SDC of 0.5-0 .9 ng/ml ; secondary end points were mean SDC and proportion of patients achieving a steady-state SDC lower than 1.0 ng/ml .
RESULTS	Postdistributive steady-state SDCs were measured 2-4 weeks after digoxin dosage adjustment or initiation .
RESULTS	Therapeutic SDCs were achieved with similar frequency in both groups ( 38.7 % in the nomogram group vs 34.5 % in the SC group , p = 0.65 ) ; however , more patients in the nomogram group had SDCs lower than 1.0 ng/ml than in the SC group ( 85.0 % vs 44.9 % , p < 0.001 ) .
RESULTS	Mean daily digoxin doses were lower in the nomogram group ( 149 67 g vs 177 74 g , p = 0.02 ) , resulting in lower mean SDCs compared with those in the SC group ( 0.52 0.30 ng/ml vs 1.12 0.58 ng/ml , p < 0.001 ) .
RESULTS	Patients in the pharmacogenetic substudy provided blood samples for genotyping of three common ABCB1 single nucleotide polymorphisms : C1236T ( rs1128503 ) , G2677T/A ( rs2032582 ) , and C3435T ( rs1045642 ) .
RESULTS	SDCs were not significantly associated with ABCB1 genotypes .
CONCLUSIONS	Our simplified digoxin dosing nomogram resulted in lower SDCs compared with standard dosing practices but achieved therapeutic SDCs with similar frequency .
CONCLUSIONS	A greater proportion of patients dosed according to our nomogram had SDCs lower than 1.0 ng/ml , consistent with consensus guidelines .
CONCLUSIONS	Genetic polymorphisms of the ABCB1 gene were not associated with SDC .

###24450365
METHODS	Randomized controlled trial .
METHODS	Objective To determine if force magnitude during posterior-to-anterior mobilization affects immediate and short-term outcomes in patients with chronic , nonspecific neck pain .
BACKGROUND	The optimal dose of mobilization to effectively treat patients with neck pain is not known .
METHODS	Patients with neck pain of at least 3 months in duration ( n = 64 ) were randomized to receive a single treatment of posterior-to-anterior mobilization applied with 30 N or 90 N of mean peak force ( 3 sets of 30 seconds ) or a placebo ( detuned laser ) on the spinous process at the painful spinal level .
METHODS	Pressure pain threshold , pain measured with a visual analog scale ( range , 0-100 mm ) , cervical range of motion , and spinal stiffness at the painful spinal level ( measured with a custom device and normalized as a percentage of C7 stiffness ) were assessed before , immediately after , and at a mean SD follow-up of 4.0 1.8 days following treatment .
METHODS	Repeated-measures analysis of covariance and Bonferroni-adjusted post hoc tests determined group differences for each outcome measure after treatment and at follow-up .
RESULTS	At follow-up , the 90-N group had less pain than the 30-N group ( mean difference , 11.3 mm ; 95 % confidence interval : 0.1 , 22.6 mm ; P = .048 ) and lower stiffness than the placebo group ( mean difference , 17.5 % ; 95 % confidence interval : 4.2 % , 30.9 % ; P = .006 ) .
RESULTS	These differences were not present immediately after treatment .
RESULTS	There were no significant between-group differences in pressure pain threshold or range of motion after treatment or at follow-up .
CONCLUSIONS	A specific dose of mobilization , in terms of applied force , appears necessary for reducing stiffness and potentially pain in patients with chronic neck pain .
CONCLUSIONS	Changes were not observed immediately after mobilization , suggesting that its effects are not directly mechanical .
BACKGROUND	Australian and New Zealand Clinical Trials Registry ( http://www.anzctr.org.au/ ) : ACTRN12611000374965 .
METHODS	Therapy , level 1b - .

###24670999
OBJECTIVE	To measure the value of augmented reality technology usage to teach the medical students performing binocular indirect ophthalmoscopy .
METHODS	Thirty-seven medical students were randomly assigned to the training of binocular indirect ophthalmoscopy either in the conventional way or with augmented reality ophthalmoscopy ( ARO ) .
METHODS	For testing student 's skills , they had to examine a real person using a conventional ophthalmoscopy system and draw the optic disk .
METHODS	They also had to fill out a questionnaire .
METHODS	Subjective and objective evaluations were performed .
RESULTS	Thirty-seven students were randomly assigned to two groups .
RESULTS	Eighteen students were trained with conventional ophthalmoscopy and 19 students with ARO .
RESULTS	The questionnaires showed no differences .
RESULTS	Performing an objective analysis , the median ophthalmoscopy training score for the conventional ophthalmoscopy group was 1.2 ( range , 0.67-2 ) and showed a significant difference ( P < 0.0033 ) to the ARO group ( median 2 ; range , 0.67-2 ) .
CONCLUSIONS	The study provides evidence that a single ARO training is efficient to improve ophthalmoscopy skills .
CONCLUSIONS	As the objective analysis showed , the ARO group had a significantly superior performance .
CONCLUSIONS	Our study also indicates that subjective evaluation of the fundus drawings without systematic analysis is prone to errors .

###25001365
BACKGROUND	Neck circumference ( NC ) has been previously related to cardiometabolic risk factors .
BACKGROUND	In this study we examined the association between NC and early stage atherosclerosis in Chinese adults .
METHODS	The study samples were from a community-based health examination survey in central China .
METHODS	In total 2,318 men and women ( 18-64 y ) were included in the final analyses .
METHODS	Carotid radial pulse wave velocity ( crPWV ) , carotid femoral PWV ( cfPWV ) , carotid artery dorsalis pedis PWV ( cdPWV ) and NC were measured .
RESULTS	After adjustment for age , sex , lipids , glucose , blood pressure , heart rate , body mass index ( BMI ) , high NC was significantly associated with an increasing trend of cfPWV , cdPWV and crPWV ( P = 0.001 , 0.049 , and 0.038 ; respectively ) .
RESULTS	In addition , we found significant interaction between hypertension status and NC level in relation to cfPWV , adjusted for age , sex , BMI , fasting glucose , lipids and heart rate ( P for interaction = 0.034 ) .
RESULTS	The associations between NC and cfPWV were significant ( P = 0.02 ) among those with hypertension , but not significant among those without hypertension .
CONCLUSIONS	Our data showed that high NC was associated with an increased risk of early stage atherosclerosis in Chinese adults , independent of other metabolic risk factors .
CONCLUSIONS	Hypertension might modify the association between NC and cfPWV .

###24418693
BACKGROUND	Platinum-based chemotherapy is the cornerstone of treatment of advanced non-small-cell lung cancer ( NSCLC ) patients , but the efficacy of adding cisplatin to single-agent chemotherapy remains to be demonstrated in prospective phase III trials dedicated to elderly patients .
BACKGROUND	Furthermore , the superiority of cisplatin/pemetrexed over cisplatin/gemcitabine in non-squamous NSCLC has not been confirmed prospectively .
BACKGROUND	We present the rationale and design of two open-label , multicenter , randomized phase III trials for elderly patients with advanced NSCLC Multicenter Italian Lung cancer in the Elderly Study ( MILES ) -3 and MILES-4 .
BACKGROUND	The aim is to evaluate the efficacy of adding cisplatin to single-agent chemotherapy ( both trials ) and the efficacy of pemetrexed versus gemcitabine in non-squamous tumors ( MILES-4 ) .
METHODS	Both trials are dedicated to first-line therapy of patients older than 70 years with advanced NSCLC , ECOG performance status 0-1 .
METHODS	In the MILES-3 trial , patients are randomized in a 11 ratio to gemcitabine or cisplatin/gemcitabine .
METHODS	In the MILES-4 study patients with non-squamous histology are randomized , in a factorial design with 1111 ratio , to four arms : gemcitabine ( A ) , cisplatin/gemcitabine ( B ) , pemetrexed ( C ) , cisplatin/pemetrexed ( D ) .
METHODS	Two comparisons are planned A+C vs B+D to test the role of cisplatin ; A+B vs C+D to test the role of pemetrexed .
METHODS	Primary endpoint of both trials is overall survival .
METHODS	Secondary and exploratory endpoints include progression-free survival , response rate , toxicity , and quality of life .
CONCLUSIONS	MILES-3 and MILES-4 results will add important evidence about the role of cisplatin-based doublets and pemetrexed in the first-line therapy of elderly patients with advanced NSCLC .

###24748353
BACKGROUND	Birth and immediate postpartum period pose many challenges for the newborn .
BACKGROUND	The neonatal mortality rates are high in India , whereas the breastfeeding rates are still low .
BACKGROUND	Hence , need exists for a simple and easily applicable intervention , which may counter these challenges .
OBJECTIVE	The present study was undertaken to evaluate the effects of very early skin-to-skin contact ( SSC ) , in term babies with their mothers , on success of breastfeeding and neonatal well-being .
METHODS	Randomized control trial conducted over 2 years ' period in a tertiary care hospital .
METHODS	Healthy babies delivered normally were included .
METHODS	Very early SSC between mothers and their newborns was initiated in the study group .
METHODS	We studied effective suckling ( using modified infant breastfeeding assessment tool [ IBFAT ] ) , breastfeeding status at 6 weeks , maternal satisfaction , thermal regulation , baby 's weight and morbidity .
METHODS	T-test , Pearson Chi-square test and non-parametric Mann-Whitney test were used through relevant Windows SPSS software version 16.0 .
RESULTS	We observed that SSC contributed to better suckling competence as measured by IBFAT score ( P < 0.0001 ) .
RESULTS	More babies in the SSC group were exclusively breastfed at first follow-up visit ( P = 0.002 ) and at 6 weeks ( P < 0.0001 ) .
RESULTS	SSC led to higher maternal satisfaction rates , better temperature gain in immediate post-partum period , lesser weight loss was at discharge and at first follow-up ( all P < 0.0001 ) and lesser morbidity than the study group ( P = 0.006 ) .
CONCLUSIONS	Very early SSC is an effective intervention that improves baby 's suckling competence , maternal satisfaction , breastfeeding rates and temperature control and weight patterns .

###25342100
BACKGROUND	Hypnotic drugs tend to be the dominant form of treatment of insomnia , but these come with a number of reported side effects .
BACKGROUND	Acupuncture has been studied as an alternative , resulting in a rising need for methodological research towards verifying its efficacy as insomnia treatment .
METHODS	We describe a proposal for a single-center , patient-assessor-blinded , randomized controlled trial with two parallel arms .
METHODS	A total of 38 patients complete screening tests at the first visit , are registered into the clinical trial , and then randomly assigned to the experimental or sham control groups ( 19 patients for each group ) .
METHODS	All subjects are clinical insomnia patients who score a 6 or above on the Pittsburgh Sleep Quality Index ( PSQI ) and meet all inclusion criteria .
METHODS	All subjects are treated with acupuncture and intradermal acupuncture ( IDA ) three times during the first week .
METHODS	Five sham acupoints are used in the control group .
METHODS	In the experimental group , five real acupoints ( PC6 , SP6 , HT7 , KI6 , and BL62 ) are used unilaterally in turn .
METHODS	Sham acupoints are over 1 cm away from each real acupoint.The primary outcomes are the scores on the Insomnia Severity Index ( ISI ) and PSQI .
METHODS	Secondary outcomes are the sleep log , the Beck Depression Inventory ( BDI ) , the State-Trait Anxiety Inventory ( STAI ) , the World Health Organization Quality of Life Abbreviated Version ( WHOQOL-BREF ) , the Korean-Auditory Verbal Learning Test ( K-AVLT ) , the Digit Span Test ( DS ) , Event Related Potentials ( ERPs ) and heart rate variability ( HRV ) to assess emotional states , sleep quality , cognitive functioning , and electro-physiological changes.Subjects are assessed at three time points : baseline , post-treatment and follow-up .
METHODS	The duration of the clinical trial is 18 days .
CONCLUSIONS	To study the enhancement of the effectiveness of acupuncture for insomnia , we test the intradermal acupuncture method , which is performed continuously on the subject 's skin and stimulated at home by the subject every night .
CONCLUSIONS	In the trial , objective measurements including ERPs and HRV are used to evaluate states of cognition and autonomic nervous system functioning and subjective self-report questionnaires assess insomnia symptoms .
CONCLUSIONS	` Sham ' acupuncture points provided by STRICTA are used for the control group .
BACKGROUND	ClinicalTrials.gov : NCT01956760 , registered 5 September 2013 .

###24465565
OBJECTIVE	To examine the effects of exercise intensity on acute changes in endothelial function in lean and obese adults .
METHODS	Sixteen lean ( BMI < 25 , age 23 3 yr ) and 10 obese ( BMI > 30 , age 26 6 yr ) physically inactive adults were studied during 3 randomized admissions [ control ( C , no exercise ) , moderate-intensity exercise ( M , @ lactate threshold ( LT ) ) and high-intensity exercise ( H , midway between LT and VO2peak ) ( 30 min ) ] .
METHODS	Endothelial function was assessed by flow-mediated dilation ( FMD ) at baseline and 1 , 2 , and 4 h post-exercise .
RESULTS	RM ANCOVA revealed significant main effects for group , time , and group x condition interaction ( p < 0.05 ) .
RESULTS	A diurnal increase in FMD was observed in lean but not obese subjects .
RESULTS	Lean subjects exhibited greater increases in FMD than obese subjects ( p = 0.0005 ) .
RESULTS	In the obese group a trend was observed for increases in FMD at 2 - and 4-hr after M ( p = 0.08 ) .
RESULTS	For lean subjects , FMD was significantly elevated at all time points after H.
RESULTS	The increase in FMD after H in lean subjects ( 3.2 0.5 % ) was greater than after both C ( 1.7 0.4 % , p = 0.015 ) and M ( 1.4 0.4 % , p = 0.002 ) .
RESULTS	FMD responses of lean and obese subjects significantly differed after C and H , but not after M.
CONCLUSIONS	In lean young adults , high-intensity exercise acutely enhances endothelial function , while moderate-intensity exercise has no significant effect above that seen in the absence of exercise .
CONCLUSIONS	The FMD response of obese adults is blunted compared to lean adults .
CONCLUSIONS	Diurnal variation should be considered when examining the effects of acute exercise on FMD .

###25553889
BACKGROUND	Novel therapies are needed for difficult-to-treat populations of patients with psoriasis .
OBJECTIVE	We sought to assess the efficacy and safety of the interleukin-17 Receptor A inhibitor brodalumab in patients with psoriasis with or without a self-reported history of psoriatic arthritis ( PsA ) and with or without a history of biologic use .
METHODS	Subset analyses of a phase II , randomized , double-blind , placebo-controlled study of brodalumab in patients with moderate-to-severe plaque psoriasis were performed .
METHODS	Improvement from baseline in Psoriasis Area and Severity Index score of 75 % , 90 % , and 100 % at week 12 ; static Physician Global Assessment ( 0/1 ) score ; Dermatology Life Quality Index response ; and Psoriasis Symptom Inventory response were evaluated within subgroups .
RESULTS	Efficacy and quality-of-life measures were generally similar between subgroups of patients with or without a history of PsA and with or without a history of biologic use across brodalumab doses and were significantly higher among patients who received brodalumab 140 mg every 2 weeks or 210 mg every 2 weeks versus placebo .
CONCLUSIONS	Differences between subgroups were not compared statistically , PsA was self-reported , only skin involvement/symptoms were reported , and reasons for discontinuation of prior biologic were not captured .
CONCLUSIONS	Brodalumab is efficacious in patients with psoriasis with or without a history of PsA or biologic use .

###25350037
OBJECTIVE	The effect of exercise training during the course of pregnancy on the newborn 's birth weight is unclear .
OBJECTIVE	This study examines the effect of aerobic and strength conditioning exercise performed during the second and the third trimester of pregnancy in nulliparous , previously inactive women on the newborn 's outcome .
METHODS	Sixty-three nulliparous , previously sedentary , were randomly assigned to either an exercise ( N. = 30 ) or a control ( N. = 33 ) group .
METHODS	The subjects participated in the exercise group ( EG ) focused on aerobic and strength-conditioning exercise in three sessions for about 20 weeks .
METHODS	We registered the birth weight , birth length , gestational age at time of delivery , Apgar score and head circumference of the newborn .
RESULTS	There were no statistically significant differences between the two groups in mean birth weight , length , head circumference , and length of gestation .
RESULTS	There was a significant difference between two groups in Apgar scores at 1 min ( P = 0.036 ) and 5 min ( P = 0.015 ) with newborns of the EG scoring higher than the CG .
CONCLUSIONS	Supervised , aerobic and strength conditioning exercise performed over the second and third trimester of pregnancy does not have a negative impact on the newborn 's body size and health .

###25593135
OBJECTIVE	Stenting has been used as a rescue therapy in patients with intracranial arterial stenosis and a transient ischemic attack or stroke when on antithrombotic therapy ( AT ) .
OBJECTIVE	We determined whether the stenting versus aggressive medical therapy for intracranial arterial stenosis ( SAMMPRIS ) trial supported this approach by comparing the treatments within subgroups of patients whose qualifying event ( QE ) occurred on versus off of AT .
METHODS	The primary outcome , 30-day stroke and death and later strokes in the territory of the qualifying artery , was compared between ( 1 ) percutaneous transluminal angioplasty and stenting plus aggressive medical therapy ( PTAS ) versus aggressive medical management therapy alone ( AMM ) for patients whose QE occurred on versus off AT and between ( 2 ) patients whose QE occurred on versus off AT separately for the treatment groups .
RESULTS	Among the 284/451 ( 63 % ) patients who had their QE on AT , the 2-year primary end point rates were 15.6 % for those randomized to AMM ( n = 140 ) and 21.6 % for PTAS ( n = 144 ; P = 0.043 , log-rank test ) .
RESULTS	In the 167 patients not on AT , the 2-year primary end point rates were 11.6 % for AMM ( n = 87 ) and 18.8 % for PTAS ( n = 80 ; P = 0.31 , log-rank test ) .
RESULTS	Within both treatment groups , there was no difference in the time to the primary end point between patients who were on or off AT ( AMM , P = 0.96 ; PTAS , P = 0.52 ; log-rank test ) .
CONCLUSIONS	SAMMPRIS results indicate that the benefit of AMM over PTAS is similar in patients on versus off AT at the QE and that failure of AT is not a predictor of increased risk of a primary end point .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00576693 .

###25601294
OBJECTIVE	Research has demonstrated that after exposure treatment , re-exposure to a previously feared stimulus outside of the treatment context can result in renewal of fear .
OBJECTIVE	The current study investigated whether conducting exposure treatment in multiple real-life contexts can attenuate renewal of fear .
METHODS	Forty-six moderate to high spider fearful individuals were randomly allocated to groups that received exposure treatment in either one context or three contexts .
METHODS	Follow-up testing was conducted one week and four weeks after exposure in the treatment context or a novel context .
RESULTS	Renewal of fear was found for the single extinction context group when exposed to the feared object in a novel context with self-report of fear , heart rate , and behavioural avoidance .
RESULTS	However , renewal of fear was attenuated for the multiple extinction context group .
CONCLUSIONS	The sample included moderate to high spider fearful participants rather than clients with spider phobia , potentially limiting the generalisability of the findings to clinical populations .
CONCLUSIONS	Using multiple extinction contexts in combination with other methods of attenuating renewal ( e.g. , context similarity ) may provide a means to reduce the risk of renewal of fear .

###24360178
OBJECTIVE	To explore the effects of different antihypertensive strategies on blood pressure and urinary albumin excretion in patients with hypertension and microalbuminuria .
METHODS	For this multi-center , randomized , positively controlled clinical trial , a total of 531 patients with mild-to-moderate essential hypertension and microalbuminuria were enrolled .
METHODS	They were divided randomly into calcium channel blocker ( CCB ) , angiotensin II receptor antagonist ( ARB ) and CCB+ARB groups .
METHODS	The whole treatment period was 6 months .
RESULTS	According to ANOVA analysis , the post-therapeutic urinary albumin level decreased 20.6 , 27.6 and 30.9 mg/L in CCB , ARB and CCB+ARB groups respectively ( P = 0.067 ) .
RESULTS	And the extents of urinary albumin reduction were 31.1 and 6.6 mg/L in patients with controlled and uncontrolled blood pressure respectively ( P < 0.001 ) .
CONCLUSIONS	Effective antihypertensive therapy is a key for decreasing urinary albumin excretion in hypertensive patients .
CONCLUSIONS	As compared with calcium antagonists , ARB-containing regimens appear to be better in reducing urinary albumin .

###25440232
BACKGROUND	The study was designed to investigate the success rate and time of insertion intraosseous access during simulated resuscitation .
METHODS	This was a randomized crossover study involving 107 paramedics .
METHODS	They were timed from start of insertion attempt to successful insertion and asked to score perceived difficulty of intraosseus access devices .
METHODS	Bone injection gun ( BIG ) ( WaisMed Company , Houston , TX ) , EZ-IO ( Vidacare , Shavano Park , TX ) and Jamshidi ( Carefusion , San Diego , CA ) were used in this study .
RESULTS	Success rates for first intraosseus iniecition attempt were higher for the BIG ( 91.59 % ) than EX-IO ( 82.66 % ) or Jamshidi ( 47.66 % ) .
RESULTS	Mean procedure time was 2.00.7 vs 3.10.9 minutes for EZ-IO vs 4.21.0 minutes for Jamshidi .
CONCLUSIONS	The use of BIG is associated with excellent success rates for insertion and appears easier to use than EZ-IO or Jamshidi Intraosseus Needle .
CONCLUSIONS	Further work to evaluate the use of the intraosseus access device in the emergency medical services is required .

###24386373
BACKGROUND	Chronic hepatitis C infection is the leading cause of hepatocellular carcinoma ( HCC ) , a highly lethal malignancy with rapidly increasing prevalence in the United States .
BACKGROUND	Little is known about genetic variations and HCC risk .
BACKGROUND	This study aimed to determine if genetic variation in Wnt signaling pathway genes are associated with advanced hepatic fibrosis and inflammation risk in a hepatitis C virus ( HCV ) infected population .
METHODS	We performed a genetic association cross-sectional study evaluating single nucleotide polymorphisms ( SNPs ) in 58 candidate genes and risk of FibroSURE-Acti Test determined advanced fibrosis ( F3/F4-F 4 advanced cases vs. F0-F3 mild controls ) and inflammation ( A2/A3-A 3 advanced cases vs. A0-A2 mild controls ) .
METHODS	We calculated odds ratios ( ORs ) and 95 % confidence intervals ( CIs ) employing multivariate logistic regression .
METHODS	Haplotypes were inferred by the HAPLO.STAT program , interactions were evaluated using multifactor dimensionality reduction ( MDR ) analysis .
RESULTS	Among 425 chronically HCV-infected male veterans , 155 ( 37 % ) had advanced fibrosis and 180 ( 42 % ) had advanced inflammation .
RESULTS	Of 3016 SNPs evaluated , eight were significantly associated with fibrosis risk ( e.g. , SFRP2 rs11937424 : OR = 2.19 , 95 % CI 1.48-3 .23 , P = 0.00004 ) , and seven were significantly associated with inflammation risk ( e.g. , SFRP1 rs16890282 : OR = 2.15 , 95 % CI 1.39-3 .16 , P = 0.0004 ) .
RESULTS	MDR analysis identified overweight/obese , SOST rs1405952 , SFRP2 rs11937424 , and FZD4 rs11234870 as the best interaction model for predicting risk of fibrosis ; whereas race/ethnicity , FZD1 rs1346665 , and TBX3 rs1520177 as the best interaction model for predicting risk of inflammation .
CONCLUSIONS	Polymorphisms in several genes involved in the Wnt signaling pathway were associated with hepatic fibrosis or inflammation risk in HCV-infected males .
CONCLUSIONS	Additional studies in other multi-ethnic HCV cohorts are needed to validate our findings in males and to assess if similar associations exist in chronically HCV-infected females .

###25444805
BACKGROUND	During the 2009 influenza pandemic both seasonal and 2009 pandemic vaccines were recommended .
BACKGROUND	We conducted a randomized trial of monovalent 2009-H1N1 vaccine and seasonal trivalent inactivated influenza vaccine ( IIV3 ) given sequentially or concurrently to adults .
METHODS	Adults randomized to 4 study groups and stratified by age ( 18-64 and 65 years ) received 1 dose of seasonal IIV3 or placebo and 2 doses of 2009-H1N1 vaccine or placebo in one of 4 combinations , i.e. , H1N1 + Placebo/H1N1 + Placebo/IIV3 ( HP/HP/V3 ) , H1N1 + IIV3/H1N1 + Placebo/Placebo ( HV3/HP/P ) , H1N1 + Placebo/H1N1 + IIV3/Placebo ( HP/HV3/P ) , and IIV3 + Placebo/H1N1 + Placebo/H1N1 ( V3P/HP/H ) .
METHODS	Intramuscular injections were given three times at 21 day intervals .
METHODS	Sera for antibody assays were obtained prior to and 21 days after each vaccination .
METHODS	Reactogenicity and adverse events were monitored .
RESULTS	Eight hundred-five ( 805 ) adults were enrolled .
RESULTS	All combinations of vaccines were safe and well tolerated .
RESULTS	In general , one dose of 2009-H1N1 and one dose of IIV3 , regardless of sequence or concurrency of administration , were immunogenic in adults .
RESULTS	There were no significant differences in geometric mean titers ( GMT ) or the proportions of subjects with 4-fold rise in antibody responses and titers 40 for any vaccine group or between age strata for 2009-H1N1 after the first or second dose , although the vaccine sequence affected the titers to the IIV3 antigens .
RESULTS	Hemagglutination inhibition antibody ( HAI ) GMTs against 2009-H1N1 for the combined age strata 21 days after the first 2009-H1N1 dose were 190.4 , 182.1 , 232.9 and 157.5 for HP/HP/V3 , HV3/HP/P , HP/HV3/P and V3P/HP/H , respectively .
RESULTS	While IIV3 GMTs were adequate they were generally lower than the 2009-H1N1 GMTs .
RESULTS	In a subset of subjects , there was good correlation between HAI and microneutralization ( MN ) titers ( Spearman 's correlation coefficient 0.92 ) .
CONCLUSIONS	All vaccine combinations were generally well tolerated .
CONCLUSIONS	Immune responses to one dose of 2009-H1N1 were adequate regardless of the sequence of vaccination in all age groups , but the sequence affected titers to IIV3 antigens .

###25799193
OBJECTIVE	To determine whether children with calcium-deficiency rickets respond better to treatment with calcium as limestone or as ground fish .
METHODS	Nigerian children with active rickets ( n = 96 ) were randomized to receive calcium as powdered limestone ( 920 mg of elemental calcium ) or ground fish ( 952 mg of elemental calcium ) daily for 24 weeks .
METHODS	Radiographic healing was defined as achieving a score of 1.5 or less on a 10-point scale .
RESULTS	The median ( range ) age of enrolled children was 35 ( 6-151 ) months .
RESULTS	Of the 88 children who completed the study , 29 ( 66 % ) in the ground fish group and 24 ( 55 % ) in the limestone group achieved the primary outcome of a radiographic score of 1.5 or less within 6 months ( P = .39 ) .
RESULTS	The mean radiographic score improved from 6.2 2.4 to 1.8 2.2 in the ground fish group and from 6.3 2.2 to 2.1 2.4 in the limestone group ( P = .68 for group comparison ) .
RESULTS	In an intention to treat analysis adjusted for baseline radiographic score , age , milk calcium intake , and serum 25-hydroxyvitamin D concentration , the response to treatment did not differ between the 2 groups ( P = .39 ) .
RESULTS	Younger age was associated with more complete radiographic healing in the adjusted model ( aOR 0.74 [ 95 % CI 0.57-0 .92 ] ) .
RESULTS	After 24 weeks of treatment , serum alkaline phosphatase had decreased , calcium and 25-hydroxyvitamin D increased , and bone mineral density increased in both groups , without significant differences between treatment groups .
CONCLUSIONS	In children with calcium-deficiency rickets , treatment with calcium as either ground fish or limestone for 6 months healed rickets in the majority of children .

###24314888
OBJECTIVE	To compare the efficacy of duloxetine with placebo on depression in elderly patients with major depressive disorder .
METHODS	Multicenter , 24-week ( 12-week short-term and 12-week continuation ) , randomized , placebo-controlled , double-blind trial .
METHODS	United States , France , Mexico , Puerto Rico .
METHODS	Age 65 years or more with major depressive disorder diagnosis ( one or more previous episode ) ; Mini-Mental State Examination score20 ; Montgomery-Asberg Depression Rating Scale total score20 .
METHODS	Duloxetine 60 or 120 mg/day or placebo ; placebo rescue possible .
METHODS	Primary-Maier subscale of the 17-item Hamilton Depression Rating Scale ( HAMD-17 ) at week 12 .
METHODS	Secondary-Geriatric Depression Scale , HAMD-17 total score , cognitive measures , Brief Pain Inventory ( BPI ) , Numeric Rating Scales ( NRS ) for pain , Clinical Global Impression-Severity scale , Patient Global Impression of Improvement in acute phase and acute plus continuation phase of treatment .
RESULTS	Compared with placebo , duloxetine did not show significantly greater improvement from baseline on Maier subscale at 12 weeks , but did show significantly greater improvement at weeks 4 , 8 , 16 , and 20 .
RESULTS	Similar patterns for Geriatric Depression Scale and Clinical Global Impression-Severity scale emerged , with significance also seen at week 24 .
RESULTS	There was a significant treatment effect for all BPI items and 4 of 6 NRS pain measures in the acute phase , most BPI items and half of the NRS measures in the continuation phase .
RESULTS	More duloxetine-treated patients completed the study ( 63 % versus 55 % ) .
RESULTS	A significantly higher percentage of duloxetine-treated patients versus placebo discontinued due to adverse event ( 15.3 % versus 5.8 % ) .
CONCLUSIONS	Although the antidepressant efficacy of duloxetine was not confirmed by the primary outcome , several secondary measures at multiple time points suggested efficacy .
CONCLUSIONS	Duloxetine had significant and meaningful beneficial effects on pain .

###25343963
BACKGROUND	Patients with primary cutaneous melanomas that are ulcerated and > 2 mm in thickness , > 4 mm in thickness and those with nodal micrometastases at diagnosis , have few options for adjuvant treatment .
BACKGROUND	Recent studies have suggested a role for vitamin D to delay melanoma recurrence and improve overall prognosis .
METHODS	This is a pilot placebo-controlled randomised phase II trial to assess the feasibility , safety and toxicity of an oral loading dose of Vitamin D ( 500,000 IU ) followed by an oral dose of 50,000 IU of Vitamin D monthly for 2 years in patients who have been treated for cutaneous melanoma by wide excision of the primary .
METHODS	Patients aged 18-79 years who have completed primary surgical treatment and have Stage IIb , IIc , IIIa ( N1a , N2a ) or IIIb ( N1a , N2a ) disease are eligible for randomisation 2:1 to active treatment or placebo .
METHODS	The primary endpoints are sufficiency of dose , adherence to study medication and safety of the drug .
METHODS	The secondary endpoints are participation and progression free survival .
METHODS	The study has been approved by the Ethics Review Committee ( RPAH Zone ) of the Sydney Local Health District , protocol number X09-0138 .
CONCLUSIONS	Effective , non-toxic adjuvant therapy for high risk primary melanoma is not currently available .
CONCLUSIONS	Favorable outcomes of this phase II study will form the basis for a multi-centre phase III study to assess whether the addition of oral high-dose vitamin D therapy in patients who have completed primary treatment for melanoma and are at high risk of recurrence will : 1 .
CONCLUSIONS	prolong time to recurrence within 5 years 2 .
CONCLUSIONS	improve overall survival at 5 years and 3 .
CONCLUSIONS	be both safe and tolerable .
CONCLUSIONS	62 patients have been randomised since the study commenced in December 2010 .
CONCLUSIONS	Target accrual for the study has been met with 75 patients randomised between December 2010 and August 2014 .
CONCLUSIONS	The Mel-D trial is conducted by the Australia and New Zealand Melanoma Trials Group ( ANZMTG 02.09 ) TRIAL REGISTRATION : Australia and New Zealand Clinical Trials Registry ( ANZCTR ) ACTRN12609000351213 .

###25392341
OBJECTIVE	Acute kidney failure after coronary artery bypass grafting ( CABG ) is a serious complication that increases morbidity and mortality rates .
OBJECTIVE	Early detection and prevention of this complication are very important .
OBJECTIVE	A novel biomarker named neutrophil gelatinase-associated lipocalin ( NGAL ) can play an important role in early diagnosis of acute kidney injury .
OBJECTIVE	Recent studies on the favourable effects of Dexmedetomidine on cardiac surgery have been published .
OBJECTIVE	The aim of this study is to investigate whether there is a dose-dependent positive effect of Dexmedetomidine on neutrophil gelatinase-associated lipocalin levels and renal functions when used after CABG .
METHODS	Our randomized , triple-blinded , placebo-controlled study was conducted among 295 patients scheduled for CABG surgery between August 2009 and March 2011 in a tertiary cardiac and vascular surgery clinic .
METHODS	A total of 90 consecutive patients who met inclusion criteria were randomized and divided into three groups .
METHODS	The first group received a placebo .
METHODS	The second and the third groups received 4 and 8 g/cc concentration of the Dexmedetomidine infusion , respectively .
METHODS	Infusion rates were regulated to obtain sedation with a Ramsey sedation score of 2 or 3 .
METHODS	Patients were regrouped according to the total Dexmedetomidine dose .
METHODS	Statistical analyses of variables including serum neutrophil gelatinase-associated lipocalin values and conventional renal function tests were made for all six possibilities before the blind was broken .
RESULTS	Results of conventional renal function tests were not significantly different .
RESULTS	However , neutrophil gelatinase-associated lipocalin levels for the first postoperative day for placebo , low-dose and high-dose Dexmedetomidine groups were 176.8 145.9 , 97.7 63.4 and 67.3 10.9 ng/ml , respectively .
RESULTS	These values were significantly different among the groups ( P < 0.001 ) .
CONCLUSIONS	In our study , we found that Dexmedetomidine infusion for sedation after CABG under cardiopulmonary bypass can be useful in the prevention of kidney injury .
CONCLUSIONS	Conventional renal function tests , including blood urea nitrogen , serum creatinine , urine output and creatinine clearance rate measurements typically may not detect the development of acute kidney dysfunction in the first 48-h postoperative period .
CONCLUSIONS	Differences were detected in renal function in the early postoperative period and the development of acute kidney injury , as determined by measurements of blood NGAL levels , was significant and dose-dependent .

###24740484
OBJECTIVE	To report the efficacy of transcutaneous functional electrical stimulation ( FES ) in children with refractory neuropathic urinary incontinence secondary to myelomeningocele ( MMC ) .
METHODS	Thirty children with history of MMC ( 12 girls and 18 boys , mean age 6.7 3.6 years ) with refractory urinary incontinence were enrolled in this study .
METHODS	They were randomly allocated to treatment ( FES , 15 children ) and control ( sham stimulation , 15 children ) groups .
METHODS	All patients underwent urodynamic study ( UDS ) before and 6 months after FES considering detrusor leak point pressure ( DLPP ) , mean maximal detrusor pressure , and mean maximal bladder capacity .
METHODS	Daily incontinence score , frequency of pad changing , and enuresis were also assessed before and 6 months after treatment .
METHODS	A 15-course FES was performed for 15 min and 3 times per week .
METHODS	Children were followed for at least 6 months .
RESULTS	Of UDS variables , DLPP increased significantly from 32 10.7 cmH2O before treatment to 55.6 24.9 cmH2O in treatment group after 6 months ( P < 0.03 ) .
RESULTS	Daily incontinence score ( range 0-3 ) improved significantly in treatment group from 2.7 0.4 before treatment to 1.3 0.9 after treatment compared with sham stimulation group ( P < 0.02 ) .
CONCLUSIONS	This type of electrical stimulation is a safe , noninvasive , and effective modality to improve urinary incontinence in myelomeningocele children and can be used at home .

###24742255
OBJECTIVE	To examine whether maternal-child interaction during feedings was suboptimal in dyads in which the infant had gastroesophageal reflux disease ( GERD ) and to compare massage therapy to a nonmassage therapy sham treatment in improving the mother-child interaction in these dyads .
METHODS	In this randomized , controlled pilot study , infants received massage therapy ( n = 18 ) or a nonmassage touch/holding sham treatment ( n = 18 ) .
METHODS	Mothers , data collectors , and the investigator who scored the feeding observations were blinded to group assignment .
METHODS	Dyads were recruited from pediatric care providers in the Denver metropolitan area and online advertisements at the University of Colorado .
METHODS	Treatments were given in the home of the dyad .
METHODS	Healthy infants , born at 38-42 weeks gestational age , were 5-10 weeks of age at enrollment ; had a score of at least 16 on the Infant Gastroesophageal Reflux Questionnaire-Revised ; and were diagnosed with GERD by their pediatric provider .
METHODS	Mothers were English speaking and at least 18 years of age .
METHODS	Treatments were given for 30 minutes twice weekly for 6 weeks .
METHODS	A certified infant massage therapist administered massage , and a registered nurse or physical therapist experienced with infants administered the control treatment .
METHODS	Maternal and infant scores on the Nursing Child Assessment of Feeding Scale ( NCAFS ) .
RESULTS	NCAFS scores were significantly lower than national norms .
RESULTS	Small to moderately sized effects showing improvement in the massage group relative to the nonmassage group were seen for Sensitivity to Cues , Social-Emotional Growth Fostering , Cognitive Growth Fostering , and Clarity of Cues ( Cohen d ) and ranged from 0.24 to 0.56 .
CONCLUSIONS	Mothers and infants with GERD experience significantly worse interactions than those without GERD .
CONCLUSIONS	Massage given twice weekly by a professional trended toward improved interaction during feeding .
CONCLUSIONS	Daily maternal administration of massage may have a positive effect on the relationship .

###25469528
BACKGROUND	Microbial translocation has been associated with an increase in immune activation and inflammation in HIV infection despite effective highly active antiretroviral therapy .
BACKGROUND	It has been shown that some probiotics have a beneficial effect by reducing intestinal permeability and , consequently , microbial translocation .
OBJECTIVE	To assess changes in microbial translocation and inflammation after treatment with probiotics ( Saccharomyces boulardii ) in HIV-1-infected patients with virologic suppression .
METHODS	A double-blind , randomized , placebo-controlled trial was conducted in 44 nonconsecutive HIV-1-infected patients with viral load of < 20 copies per milliliter for at least 2 years .
METHODS	Patients were randomized to oral supplementation with probiotics or placebo during 12 weeks .
METHODS	Markers of microbial translocation ( lipopolysaccharide-binding protein [ LBP ] and soluble CD14 ) , inflammation ( interleukin 6 [ IL-6 ] , tumor necrosis factor alpha , interferon gamma , high-sensitivity C-reactive protein ) , and immunological and clinical data were determined before and after the intervention and 3 months after treatment discontinuation .
METHODS	Quantitative variables were compared using the Mann-Whitney U test , and categorical variables were compared using the Fisher exact test .
RESULTS	After 12 weeks of treatment , differences between the probiotic arm and the placebo arm were observed in LBP values ( -0.30 vs +0.70 pg/mL ) and IL-6 ( -0.60 vs +0.78 pg/mL ) .
RESULTS	These differences were also noted at 3 months after treatment withdrawal .
RESULTS	Qualitative analysis was performed , defining a variable as `` decreased '' or `` increased '' from baseline LBP .
RESULTS	A significant decrease of LBP at 12 weeks of treatment was observed ( 57.9 % patients in the probiotic group vs 6.2 % in the placebo group , P = 0.002 ) .
CONCLUSIONS	Treatment with S. boulardii decreases microbial translocation ( LBP ) and inflammation parameters ( IL-6 ) in HIV-1-infected patients with long-term virologic suppression .

###25786050
OBJECTIVE	The aims of the study were to assess the efficacy of a multicomponent intervention and evaluate the feasibility and user acceptance of an internet-based home telemedical surveillance system for the evaluation of pain and other key health outcomes in patients with fibromyalgia ( FM ) .
METHODS	The study involved 76 FM patients who were randomised to usual care or the multicomponent exercise programme , which consisted of 24 twice-weekly sessions of combined aerobic , muscle strength training exercises and education .
METHODS	All the patients completed the revised version of the Fibromyalgia Impact Questionnaire ( FIQR ) and the self-administered Fibromyalgia Activity Score ( FAS ) .
METHODS	A predefined website allowed authorised users to enter data via a personal computer ( PC ) and Internet browser .
METHODS	The differences between the groups were assessed using the Mann-Whitney U-test and Fisher 's exact test , and the correlations were analysed using Spearman 's rank correlation test .
RESULTS	The multicomponent intervention led to a clinically relevant difference in improvement in comparison with the standard approach .
RESULTS	It markedly improved the FIQR symptom subscale score , significantly increased the time-integrated area under the curve ( AUC ) of the FAS scores , and led to a greater benefit in terms of fatigue and the quality of sleep .
RESULTS	The mean change in the AUC of the total FIQR score closely correlated with the changes in the AUC of the total FAS score .
CONCLUSIONS	The multicomponent approach to FM was effective in treating the key symptoms and maintaining the improvements in the short term , and telemonitoring proved to be an easyto-use solution for patient-centred data acquisition .

###24429091
BACKGROUND	Bronchiolitis is the most common lower respiratory tract infection in infants and the leading cause of hospital admission .
BACKGROUND	Hydration is a mainstay of treatment , but insufficient evidence exists to guide clinical practice .
BACKGROUND	We aimed to assess whether intravenous hydration or nasogastric hydration is better for treatment of infants .
METHODS	In this multicentre , open , randomised trial , we enrolled infants aged 2-12 months admitted to hospitals in Australia and New Zealand with a clinical diagnosis of bronchiolitis during three bronchiolitis seasons ( April 1-Oct 31 , in 2009 , 2010 , and 2011 ) .
METHODS	We randomly allocated infants to nasogastric hydration or intravenous hydration by use of a computer-generated sequence and opaque sealed envelopes , with three randomly assigned block sizes and stratified by hospital site and age group ( 2 - < 6 months vs 6-12 months ) .
METHODS	The primary outcome was length of hospital stay , assessed in all randomly assigned infants .
METHODS	Secondary outcomes included rates of intensive-care unit admission , adverse events , and success of insertion .
METHODS	This trial is registered with the Australian and New Zealand clinical trials registry , ACTRN12605000033640 .
RESULTS	Mean length of stay for 381 infants assigned nasogastric hydration was 866 h ( SD 589 ) compared with 822 h ( 588 ) for 378 infants assigned intravenous hydration ( absolute difference 45 h [ 95 % CI -39 to 129 ] ; p = 030 ) .
RESULTS	Rates of admission to intensive-care units , need for ventilatory support , and adverse events did not differ between groups .
RESULTS	At randomisation , seven infants assigned nasogastric hydration were switched to intravenous hydration and 56 infants assigned intravenous hydration were switched to nasogastric hydration because the study-assigned method was unable to be inserted .
RESULTS	For those infants who had data available for successful insertion , 275 ( 85 % ) of 323 infants in the nasogastric hydration group and 165 ( 56 % ) of 294 infants in the intravenous hydration group required only one attempt for successful insertion .
CONCLUSIONS	Intravenous hydration and nasogastric hydration are appropriate means to hydrate infants with bronchiolitis .
CONCLUSIONS	Nasogastric insertion might require fewer attempts and have a higher success rate of insertion than intravenous hydration .
BACKGROUND	Australian National Health and Medical Research Council , Samuel Nissen Charitable Foundation ( Perpetual ) , Murdoch Children 's Research Institute , Victorian Government .

###25152283
OBJECTIVE	To investigate the effect of postoperative analgesia of ultrasound-guided transversus abdominis plane block in hemicolectomy patients .
METHODS	After obtaining approval from the Hospital Ethics Committee and informed written consent from all patients , fourty hemicolectomy patients were randomly divided into two even groups .
METHODS	After anesthesia induction and intubation , patients received ultrasound-guided bilateral transversus abdominis plane block with 0.25 % ropivacaine 60 ml ( group A ) or saline ( group B ) .
METHODS	Post-operative patient-controlled intravenous analgesia with sufentanil was provided to all patients .
RESULTS	Compared with group B , group A had less BP , HR changes at skin incision and needed less intraoperative sufentanil ( ( 0.25 0.16 ) g/kg vs ( 0.35 0.21 ) g/kg ) ( P < 0.05 ) to maintain anesthesia .
RESULTS	Group A had lower VAS than group B at 1 , 4 , 8 , 12 , 24 h after surgery ( P < 0.05 ) , less PCA demand ( 2.9 1.6 vs 9.1 1.8 ) ( P < 0.05 ) and less PCA sufentanil consumption ( ( 69.1 5.8 ) g vs ( 92.6 6.9 ) g ) ( P < 0.05 ) , thus less post-operative nausea or vomiting and higher satisfaction ( P < 0.05 ) .
RESULTS	No complications associated to transversus abdominis plane block were found .
CONCLUSIONS	Ultrasound-guided transversus abdominis plane block provided safe and effective post-operative analgesia for hemicolectomy patients .

###24585405
BACKGROUND	Although autoantibodies to cancer antigens are candidates for biomarkers , no comprehensive studies to detect cancer-specific antibodies have been performed .
BACKGROUND	This study identified autoantibodies in the sera of pancreatic cancer ( PC ) patients using proteomics based on a wheat germ cell-free protein production system .
METHODS	We constructed a biotinylated protein library of 2,183 genes .
METHODS	Interactions between biotinylated proteins and serum antibodies were detected by AlphaScreen assay .
METHODS	Relative luminescence signals of each protein in 37 PC patients and 20 healthy controls were measured , and their sensitivity and specificity for PC were calculated .
RESULTS	Luminescence signals of nine proteins were significantly higher than those of healthy controls , with calcium and integrin binding 1 ( CIB1 ) protein showing the greatest significance ( p = 0.002 ) .
RESULTS	Sensitivity , specificity , positive predictive value and negative predictive value of CIB1 autoantibody alone for PC were 76 , 70 , 82 , and 61 % , respectively , and 97 , 35 , 74 , and 88 % , respectively , when the four most significant proteins were combined .
RESULTS	Presence of these autoantibodies did not vary significantly with other clinicopathological characteristics .
CONCLUSIONS	Several autoantibodies , including CIB1 , are potential biomarkers for PC .

###24450342
BACKGROUND	Single-incision laparoscopic cholecystectomy ( SILC ) is considered to be less invasive and have less morbidity than conventional laparoscopic cholecystectomy ( CLC ) .
BACKGROUND	However , there is a relative paucity of data regarding postoperative pain scores in rural Indian populations following SILC .
BACKGROUND	Also , data pertaining to the applicability of SILC in rural Indian population are scant .
METHODS	In the present randomized control trial , pain scores after SILC and CLC were evaluated .
METHODS	Sixty patients with gallstone disease were randomly assigned to one of two groups with 30patients each : the CLC group and the SILC group .
METHODS	Postoperative pain scores were recorded on the visual analog scale at 8 hours , 24 hours and 7 days after surgery .
RESULTS	The patients were comparable with respect to age , sex and BMI .
RESULTS	Operative time was longer for the SILC group ( 47.735.57 min vs 69.538.96 min ; P < 0.0001 ) .
RESULTS	The pain scores were similar in both groups at 8 hours ( 3.610.41 vs 3.500.51 ; P = 0.36 ) and 24 hours ( 3.300.59 vs 3.200.40 ; P = 0.44 ) postoperatively .
RESULTS	On day 7 , the SILC group had lower pain scores than the CLC group ( 2.560.56 vs 1.160.37 ; P < 0.01 ) .
CONCLUSIONS	There was no distinct advantage to SILC with regard to immediate postoperative pain .
CONCLUSIONS	Pain was significantly less ( P < 0.01 ) in the SILC group on postoperative day 7 .

###25287455
OBJECTIVE	School-based health centers ( SBHCs ) have been suggested as possible patient-centered medical homes .
OBJECTIVE	Our objectives were to determine , in a low-income , urban population , adolescents ' reasons for visiting SBHCs and the value parents place on SBHC services , and adolescents ' and parents ' assessment of how well SBHCs fulfill criteria for a medical home as defined by the American Academy of Pediatrics .
METHODS	A cross-sectional , mailed survey of a random sample of 495 adolescent SBHC users and 497 parents of SBHC users from 10 SBHCs in Denver , CO from May to October 2012 .
METHODS	Eligible adolescents were registered in an SBHC with 1 visit during the 2011 to 2012 school year .
RESULTS	Response rates were 40 % ( 198/495 ) among adolescents and 36 % ( 181/497 ) among parents .
RESULTS	The top 3 reasons for visits were for illness ( 78 % ) , vaccines ( 69 % ) , and sexual health education ( 63 % ) .
RESULTS	Factors reported as very important by > 75 % of parents in the decision to enroll their adolescent in an SBHC included clinic offering sick or injury visits , sports physicals , and vaccinations .
RESULTS	More than 70 % of adolescents gave favorable responses ( always or usually , excellent or good ) to questions about American Academy of Pediatrics medical home criteria ( accessibility , continuity , comprehensiveness , family-centeredness , coordination , and compassion ) .
RESULTS	Most parents ( 83 % ) reported that they could always or usually trust the SBHC provider to take good care of their child ; 82 % were satisfied with provider-to-provider communication .
CONCLUSIONS	In a low-income urban population , SBHCs met criteria of a medical home from adolescents ' and parents ' perspectives .
CONCLUSIONS	Policymakers and communities should recognize that SBHCs play an important role in the medical community , especially for underserved adolescents .

###24618831
BACKGROUND	The World Health Organization , governments , and communities agree that community action is likely to reduce risky alcohol consumption and harm .
BACKGROUND	Despite this agreement , there is little rigorous evidence that community action is effective : of the six randomised trials of community action published to date , all were US-based and focused on young people ( rather than the whole community ) , and their outcomes were limited to self-report or alcohol purchase attempts .
BACKGROUND	The objective of this study was to conduct the first non-US randomised controlled trial ( RCT ) of community action to quantify the effectiveness of this approach in reducing risky alcohol consumption and harms measured using both self-report and routinely collected data .
RESULTS	We conducted a cluster RCT comprising 20 communities in Australia that had populations of 5,000-20 ,000 , were at least 100 km from an urban centre ( population 100,000 ) , and were not involved in another community alcohol project .
RESULTS	Communities were pair-matched , and one member of each pair was randomly allocated to the experimental group .
RESULTS	Thirteen interventions were implemented in the experimental communities from 2005 to 2009 : community engagement ; general practitioner training in alcohol screening and brief intervention ( SBI ) ; feedback to key stakeholders ; media campaign ; workplace policies/practices training ; school-based intervention ; general practitioner feedback on their prescribing of alcohol medications ; community pharmacy-based SBI ; web-based SBI ; Aboriginal Community Controlled Health Services support for SBI ; Good Sports program for sports clubs ; identifying and targeting high-risk weekends ; and hospital emergency department-based SBI .
RESULTS	Primary outcomes based on routinely collected data were alcohol-related crime , traffic crashes , and hospital inpatient admissions .
RESULTS	Routinely collected data for the entire study period ( 2001-2009 ) were obtained in 2010 .
RESULTS	Secondary outcomes based on pre - and post-intervention surveys ( n = 2,977 and 2,255 , respectively ) were the following : long-term risky drinking , short-term high-risk drinking , short-term risky drinking , weekly consumption , hazardous/harmful alcohol use , and experience of alcohol harm .
RESULTS	At the 5 % level of statistical significance , there was insufficient evidence to conclude that the interventions were effective in the experimental , relative to control , communities for alcohol-related crime , traffic crashes , and hospital inpatient admissions , and for rates of risky alcohol consumption and hazardous/harmful alcohol use .
RESULTS	Although respondents in the experimental communities reported statistically significantly lower average weekly consumption ( 1.90 fewer standard drinks per week , 95 % CI = -3.37 to -0.43 , p = 0.01 ) and less alcohol-related verbal abuse ( odds ratio = 0.58 , 95 % CI = 0.35 to 0.96 , p = 0.04 ) post-intervention , the low survey response rates ( 40 % and 24 % for the pre - and post-intervention surveys , respectively ) require conservative interpretation .
RESULTS	The main limitations of this study are as follows : ( 1 ) that the study may have been under-powered to detect differences in routinely collected data outcomes as statistically significant , and ( 2 ) the low survey response rates .
CONCLUSIONS	This RCT provides little evidence that community action significantly reduces risky alcohol consumption and alcohol-related harms , other than potential reductions in self-reported average weekly consumption and experience of alcohol-related verbal abuse .
CONCLUSIONS	Complementary legislative action may be required to more effectively reduce alcohol harms .
BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12607000123448 .

###24887540
BACKGROUND	The aim of this study was to compare pure coagulation and blended current in the resection of large colorectal sessile polyps ( SPs ) .
METHODS	Between January 2009 and June 2012 , 84 patients ( 45 men , 39 women ; median age 66 y ; range , 42 to 88 y ) with large colorectal SPs ( diameter 2 cm ) were randomized in 1:1 ratio to undergo treatment by the `` lift and cut '' piecemeal resection technique .
METHODS	A total of 43 blended current subjects ( group A ) were well matched to 41 pure coagulation current subjects ( group B ) , with a median lesion size of 3.9 cm ( group A , 3.7 vs. group B , 4.2 cm ; P = 0.316 ) , respectively .
METHODS	The rate of complications , the factors that predict complications , and the recurrence of adenoma were analyzed .
RESULTS	Complete macroscopic resection was achieved in 39 patients ( 90.7 % ) of group A and in 36 patients ( 87.6 % ) of group B ( P = 0.735 ) .
RESULTS	Argon plasma coagulation at resection 's margins was performed in 10 patients ( 23.2 % ) of group A and in 14 patients ( 34.1 % ) of group B ( P = 0.269 ) .
RESULTS	Eight patients ( 9.5 % ) [ group A , n = 3 patients ( 7.1 % ) vs. group B , n = 5 patients ( 12 % ) ; P = 0.756 ] developed immediate ( 4 ) or delayed ( 4 ) bleeding .
RESULTS	Four patients with bleeding were under treatment with selective serotonin reuptake inhibitors .
RESULTS	All bleedings were successfully treated conservatively or with endoclipping and heater probe application .
RESULTS	Perforation occurred in 1 patient of each group and was managed by clips closure and antibiotics and right hemicolectomy , respectively .
RESULTS	Postpolypectomy syndrome was observed in 2 patients ( 4.6 % ) of group A and 3 patients ( 7.3 % ) of group B ( P = 0.834 ) .
RESULTS	In 3 patients , the histopathologic analysis of resected SPs revealed invasive carcinoma , and surgical resection was performed in 1 patient .
RESULTS	Two patients refused operation .
RESULTS	Among the patients who underwent follow-up surveillance colonoscopy , a total recurrence rate of 25.67 % of adenomas with no difference was observed between the 2 groups [ group A , n = 8 patients ( 21.6 % ) vs. group B , n = 11 patients ( 31.4 % ) ; P = 0.345 ] .
RESULTS	Recurrence of adenoma was observed in 12 patients ( 16.22 % ) without and in 7 patients ( 9.46 % ) with argon plasma coagulation treatment .
CONCLUSIONS	No difference was found in the rate of complications between the 2 types of current used in the resection of large colorectal SPs .
CONCLUSIONS	However , an influence of selective serotonin reuptake inhibitors on postpolypectomy bleeding was observed , which deserves further investigation .

###25835440
BACKGROUND	Oxidized phospholipids on apolipoprotein B-100 ( OxPL-apoB ) is a biomarker of increased risk for major adverse cardiovascular events ( MACE ) in community cohorts , but its role in patients with stable coronary heart disease ( CHD ) is unknown .
OBJECTIVE	This study sought to examine the relationship between these oxidative biomarkers and cardiovascular outcomes in patients with established CHD .
METHODS	In a random sample from the TNT ( Treating to New Targets ) trial , OxPL-apoB levels were measured in 1,503 patients at randomization ( after an 8-week run-in period taking atorvastatin 10 mg ) and 1 year after being randomized to atorvastatin 10 or 80 mg .
METHODS	We examined the association between baseline levels of OxPL-apoB and MACE , defined as death from CHD , nonfatal myocardial infarction , resuscitation after cardiac arrest , and fatal/nonfatal stroke , as well as the effect of statin therapy on OxPL-apoB levels and MACE .
RESULTS	Patients with events ( n = 156 ) had higher randomization levels of OxPL-apoB than those without events ( p = 0.025 ) .
RESULTS	For the overall cohort , randomization levels of OxPL-apoB predicted subsequent MACE ( hazard ratio [ HR ] : 1.21 ; 95 % confidence interval : 1.04 to 1.41 ; p = 0.018 ) per doubling and tertile 3 versus tertile 1 ( hazard ratio : 1.69 ; 95 % confidence interval [ CI ] : 1.14 to 2.49 ; p = 0.01 ) after multivariate adjustment for age , sex , body mass index , among others , and treatment assignment .
RESULTS	In the atorvastatin 10-mg group , tertile 3 was associated with a higher risk of MACE compared to the first tertile ( HR : 2.08 ; 95 % CI : 1.20 to 3.61 ; p = 0.01 ) but this was not significant in the atorvastatin 80-mg group ( HR : 1.40 ; 95 % CI : 0.80 to 2.46 ; p = 0.24 ) .
CONCLUSIONS	Elevated OxPL-apoB levels predict secondary MACE in patients with stable CHD , a risk that is mitigated by atorvastatin 80 mg .
CONCLUSIONS	( A Study to Determine the Degree of Additional Reduction in CV Risk in Lowering LDL Below Minimum Target Levels [ TNT ] ; NCT00327691 ) .

###24285687
OBJECTIVE	Paraoxonase 1 ( PON1 ) , an enzyme associated with high-density lipoprotein ( HDL-PON1 ) , is reported to have antioxidant and cardioprotective properties .
OBJECTIVE	The aim of the present study was to investigate the effects of anthocyanins on the HDL-PON1 activity and cholesterol efflux capacity in hypercholesterolemic subjects .
METHODS	A total of 122 hypercholesterolemic subjects were given 160 mg of anthocyanins twice daily or placebo ( n = 61 of each group ) for 24 weeks in a double-blind , randomized , placebo-controlled trial .
METHODS	Participants and investigators were masked to treatment allocation .
RESULTS	Anthocyanin consumption significantly increased HDL cholesterol and decreased low - density lipoprotein cholesterol concentrations compared with placebo ( P < .018 and P < .001 , respectively ) .
RESULTS	Anthocyanin supplementation also increased the activity of HDL-PON1 compared with placebo ( P < .001 ) .
RESULTS	Furthermore , cholesterol efflux capacity was increased more in the anthocyanin group ( 20.0 % increase ) than in the placebo group ( 0.2 % increase ) ( P < .001 ) .
RESULTS	The negative correlations established between HDL-PON1 activity and the levels of lipid hydroperoxides associated with HDL confirm the relationship between PON1 activity and lipid peroxidation of lipoproteins .
RESULTS	Furthermore , a strong positive correlation was noted between increased HDL-PON1 activity and improved cholesterol efflux capacity both before and after adjustment for HDL cholesterol and apolipoprotein AI in anthocyanin-treated subjects ( both P < .001 ) .
RESULTS	Inhibition of HDL-PON1 activity strongly prevented the antioxidant ability of HDL and attenuated the cholesterol efflux capacity of subjects from anthocyanin group .
CONCLUSIONS	Our observations suggest that the alterations of PON1 activity by anthocyanin observed in hypercholesterolemic HDL reflect a shift to an improvement of cholesterol efflux capacity of HDL and may provide a link between anthocyanin and cardioprotective effects .

###24362488
OBJECTIVE	To determine the effects of steady-state concentrations of the selective S1P1 receptor modulator ponesimod on the pharmacokinetics ( PK ) of a single dose of a combined oral contraceptive , containing 1mg norethisterone ( NET ) and 35g ethinyl estradiol ( EE ) and to investigate the effects on heart rate at different ponesimod doses within an up-titration regimen prior to co-administration of the contraceptive .
METHODS	Twenty-two healthy women ( age : 29-60years ) received twice a single oral dose of the combined oral contraceptive , alone or in combination with multiple doses of 40mg ponesimod attained by an up-titration regimen .
METHODS	Heart rate ( HR ) effects were assessed on the first day of each up-titration level .
METHODS	PK parameters of NET and EE were determined by non-compartmental analysis .
RESULTS	Geometric mean ratios ( ponesimod and contraceptive / contraceptive alone ) of Cmax and AUC0-24 of NET were 0.87 ( 90 % CI : 0.80 , 0.94 ) and 0.84 ( 90 % CI : 0.76 , 0.93 ) , respectively .
RESULTS	Geometric mean ratios of Cmax and AUC0-24 of EE were 0.94 ( 90 % CI : 0.86 , 1.03 ) and 0.95 ( 90 % CI : 0.89 , 1.01 ) , respectively .
RESULTS	The maximum mean HR reduction after the first dose of 10mg ponesimod was 12.4 bpm ( SD6 .2 ) at 2.5 h post-dose .
RESULTS	On Day 4 ( first dose of 20mg ) and Day 7 ( first dose of 40mg ) the maximum mean HR reduction was 4.3 bpm ( SD5 .7 ) and 1.4 ( SD6 .4 ) , respectively , at 2.5 h post-dose compared to baseline .
CONCLUSIONS	No clinically relevant PK interactions between ponesimod and the combined oral contraceptive were observed , therefore , efficacy of hormonal contraceptives is not expected to be affected by concomitant administration of ponesimod .
CONCLUSIONS	The up-titration regimen showed that HR reductions are diminished upon repeated ponesimod administration .

###25365133
BACKGROUND	Patellofemoral pain ( PFP ) is the most common injury in running and jumping athletes .
BACKGROUND	Randomized controlled trials suggest that incorporating hip and core strengthening ( HIP ) with knee-focused rehabilitation ( KNEE ) improves PFP outcomes .
BACKGROUND	However , no randomized controlled trials have , to our knowledge , directly compared HIP and KNEE programs .
OBJECTIVE	To compare PFP pain , function , hip - and knee-muscle strength , and core endurance between KNEE and HIP protocols after 6 weeks of rehabilitation .
OBJECTIVE	We hypothesized greater improvements in ( 1 ) pain and function , ( 2 ) hip strength and core endurance for patients with PFP involved in the HIP protocol , and ( 3 ) knee strength for patients involved in the KNEE protocol .
METHODS	Randomized controlled clinical trial .
METHODS	Four clinical research laboratories in Calgary , Alberta ; Chicago , Illinois ; Milwaukee , Wisconsin ; and Augusta , Georgia .
METHODS	Of 721 patients with PFP screened , 199 ( 27.6 % ) met the inclusion criteria ( 66 men [ 31.2 % ] , 133 women [ 66.8 % ] , age = 29.0 7.1 years , height = 170.4 9.4 cm , weight = 67.6 13.5 kg ) .
METHODS	Patients with PFP were randomly assigned to a 6-week KNEE or HIP protocol .
METHODS	Primary variables were self-reported visual analog scale and Anterior Knee Pain Scale measures , which were conducted weekly .
METHODS	Secondary variables were muscle strength and core endurance measured at baseline and at 6 weeks .
RESULTS	Compared with baseline , both the visual analog scale and the Anterior Knee Pain Scale improved for patients with PFP in both the HIP and KNEE protocols ( P < .001 ) , but the visual analog scale scores for those in the HIP protocol were reduced 1 week earlier than in the KNEE group .
RESULTS	Both groups increased in strength ( P < .001 ) , but those in the HIP protocol gained more in hip-abductor ( P = .01 ) and - extensor ( P = .01 ) strength and posterior core endurance ( P = .05 ) compared with the KNEE group .
CONCLUSIONS	Both the HIP and KNEE rehabilitation protocols produced improvements in PFP , function , and strength over 6 weeks .
CONCLUSIONS	Although outcomes were similar , the HIP protocol resulted in earlier resolution of pain and greater overall gains in strength compared with the KNEE protocol .

###24864327
OBJECTIVE	To compare visual outcome and manual handling of additional multifocal sulcus-fixated intraocular lenses ( IOLs ) of different materials and lens concepts .
METHODS	Visual outcomes after implantation of a monofocal IOL in the capsular bag followed by implantation of a sulcus-fixated multifocal IOL ( MIOL ) in patients with cataract were assessed .
METHODS	Patients were randomly assigned to receive either the refractive Sulcoflex 653F ( Rayner Surgical GmbH , Bamberg , Germany ) ( 35 eyes ) or the diffractive MS 714 PB Diff ( Dr. Schmidt Intraocularlinsen GmbH , St. Augustin , Germany ) ( 33 eyes ) additional MIOL .
METHODS	Three months postoperatively , visual acuity at far , intermediate , and near distance and contrast sensitivity under different conditions were evaluated .
METHODS	Patients with binocular implantation were asked to rate their subjective quality of vision .
RESULTS	No complications occurred during or after surgery .
RESULTS	No significant differences in uncorrected and corrected distance visual acuity at all distances were found between groups .
RESULTS	All eyes achieved uncorrected visual acuity of 0.3 logMAR ( 20/40 Snellen ) or better at all distances .
RESULTS	Contrast sensitivity was significantly better in the diffractive MS 714 PB Diff group than in the refractive Sulcoflex 653F group under all conditions .
RESULTS	The refractive Sulcoflex 653F group experienced more photic phenomena ( 81 % ) than the diffractive MS 714 PB Diff group ( 25 % ) , but the disturbances were scored as mild to moderate in most cases ( 93 % / 100 % ) .
RESULTS	The unfolding procedure of the acrylic Sulcoflex 653F IOL was smoother and more controllable than that of the silicone MS 714 PB Diff IOL .
CONCLUSIONS	Both additional MIOLs performed well in terms of far , intermediate , and near vision and enabled patients to handle almost all areas of activity without glasses .

###24345055
OBJECTIVE	The aim of this study was to evaluate the effect of an intensive physical therapy protocol in patients who contract ` intensive care unit-acquired weakness ' ( ICUAW ) , in terms of muscle strength , breathing and functional indices .
METHODS	This was a prospective , single-blinded study in a general hospital intensive care unit ( ICU ) .
METHODS	Patients who required mechanical ventilation longer than 48h and who were expected to remain mechanically ventilated for at least another 48h were randomly divided into two intervention groups : group I ( n = 9 ) - the routine care group , received physical therapy according to our daily custom protocol ; and group II ( n = 9 ) - the intensive treatment group , were treated by the same protocol twice a day .
METHODS	The main outcome measures included the Medical Research Council ( MRC ) physical strength examination , maximal inspiratory pressure ( MIP ) , hand grip dynamometer and sitting balance test .
RESULTS	Significant strength improvement from first ( T1 ) to second ( T2 ) measurements was demonstrated for variables MIP and MRC physical strength examination in favor of the intensive treatment group ( P < 0.05 ) .
RESULTS	The intensive treatment group also required shorter intensive care length of stay than the routine care group ( P = 0.043 ) .
CONCLUSIONS	It is possible that an intensive therapy protocol may facilitate the initial recovery process in patients who suffer from ICUAW .

###25156992
BACKGROUND	In patients with a first unprovoked venous thromboembolism ( VTE ) the risk of recurrent VTE remains high after anticoagulant treatment is discontinued .
BACKGROUND	The Aspirin for the Prevention of Recurrent Venous Thromboembolism ( the Warfarin and Aspirin [ WARFASA ] ) and the Aspirin to Prevent Recurrent Venous Thromboembolism ( ASPIRE ) trials showed that aspirin reduces this risk , but they were not individually powered to detect treatment effects for particular outcomes or subgroups .
RESULTS	An individual patient data analysis of these trials was planned , before their results were known , to assess the effect of aspirin versus placebo on recurrent VTE , major vascular events ( recurrent VTE , myocardial infarction , stroke , and cardiovascular disease death ) and bleeding , overall and within predefined subgroups .
RESULTS	The primary analysis , for VTE , was by intention to treat using time-to-event data .
RESULTS	Of 1224 patients , 193 had recurrent VTE over 30.4 months ' median follow-up .
RESULTS	Aspirin reduced recurrent VTE ( 7.5 % / yr versus 5.1 % / yr ; hazard ratio [ HR ] , 0.68 ; 95 % confidence interval [ CI ] , 0.51-0 .90 ; P = 0.008 ) , including both deep-vein thrombosis ( HR , 0.66 ; 95 % CI , 0.47-0 .92 ; P = 0.01 ) and pulmonary embolism ( HR , 0.66 ; 95 % CI , 0.41-1 .06 ; P = 0.08 ) .
RESULTS	Aspirin reduced major vascular events ( 8.7 % / yr versus 5.7 % / yr ; HR , 0.66 ; 95 % CI , 0.50-0 .86 ; P = 0.002 ) .
RESULTS	The major bleeding rate was low ( 0.4 % / yr for placebo and 0.5 % / yr for aspirin ) .
RESULTS	After adjustment for treatment adherence , recurrent VTE was reduced by 42 % ( HR , 0.58 ; 95 % CI , 0.40-0 .85 ; P = 0.005 ) .
RESULTS	Prespecified subgroup analyses indicate similar relative , but larger absolute , risk reductions in men and older patients .
CONCLUSIONS	Aspirin after anticoagulant treatment reduces the overall risk of recurrence by more than a third in a broad cross-section of patients with a first unprovoked VTE , without significantly increasing the risk of bleeding .
BACKGROUND	www.anzctr.org.au .
BACKGROUND	Unique identifier : ACTRN12611000684921 .

###24986113
BACKGROUND	Patient-reported outcome ( PRO ) measures are increasingly being used in clinical practice to inform individual patient management , but evidence is needed on which PROs are best suited for clinical use .
METHODS	This controlled trial randomly assigned patients with breast and prostate cancer undergoing treatment to complete one of three PRO measures : European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 ( QLQ-C30 ) , Supportive Care Needs Survey-Short Form ( SCNS-SF34 ) , or six domains from the Patient-Reported Outcomes Measurement Information System ( PROMIS ) .
METHODS	Patients completed the PRO measures before clinic visits , and the results were provided to both the patient and clinician .
METHODS	At treatment completion , patients and clinicians completed brief feedback forms on the intervention 's usefulness and value .
METHODS	Exit interviews were conducted with patients ( at end of treatment ) and clinicians ( at end of study ) .
METHODS	The primary outcome was the proportion of patients in each arm who either strongly agreed or agreed to all feedback form items .
RESULTS	Of 294 eligible patients invited to participate , 224 ( 76 % ) enrolled ( median age 66 years , 78 % white , 72 % prostate ) .
RESULTS	Of the 181 patients ( 81 % ) who completed at least one feedback form item , participants in the QLQ-C30 study arm were most likely to strongly agree/agree to all items ( 74 % ) followed by PROMIS ( 61 % ) and SCNS-SF34 ( 52 % ; P = .03 ) .
RESULTS	Of the 116 participants ( 52 % ) who completed all feedback form items , the results were similar : 82 % for the QLQ-C30 , 62 % for PROMIS , and 56 % for SCNS-SF34 ( P = .05 ) .
RESULTS	Clinicians did not prefer one questionnaire over the others .
CONCLUSIONS	These results suggest that , when using PROs in clinical practice for patient management , the measure matters in terms of usefulness to patients .

###24962242
OBJECTIVE	To assess the efficacy and tolerability of add-on pregabalin controlled-release formulation ( PGB-CR ) ( doses of 165 or 330 mg/day ) in patients with partial-onset seizures ( POS ) .
METHODS	This was a randomized , double-blind ( DB ) , parallel-group study of PGB-CR once-daily as adjunctive treatment in adults with treatment-resistant partial seizures .
METHODS	After an 8-week baseline period , eligible patients were randomized ( 1:1:1 ) to placebo , PGB-CR 165 mg , or PGB-CR 330 mg for 14 weeks , including a 2-week dose escalation .
METHODS	Primary endpoint was the loge - transformed 28-day seizure rate for all POS with observable component during the full 14-week double-blind treatment phase .
METHODS	Secondary endpoints included the 50 % responder rate and percent change from baseline in 28-day POS rate .
RESULTS	Three hundred twenty-three patients were randomized and received treatment ; placebo ( n = 110 ) , PGB-CR 330 mg ( n = 100 ) , PGB-CR 165 mg ( n = 113 ) ; and 287 ( 88.9 % ) completed the trial .
RESULTS	The primary efficacy analysis result , expressed as percent reduction from placebo , was 13.1 % and 1.0 % for PGB-CR 330 mg and PGB-CR 165 mg , respectively , and was not statistically significant ( p = 0.091 , 0.908 ) .
RESULTS	The proportion of 50 % responders was similar for placebo ( 35.8 % ) and 165 mg PGB-CR ( 37.8 % ) and nominally higher for 330 mg PGB-CR ( 45.9 % , p = 0.125 compared to placebo ) .
RESULTS	The LS mean estimates of the percent change from baseline for placebo ( -5.7 % ) was nominally smaller than 165 mg PGB-CR ( -15.0 % , p = 0.540 ) and 330 mg PGB-CR ( -31.5 % , p = 0.079 ) ; however , the median percent changes from baseline were not as well differentiated ( placebo , -35.4 % ; 165 mg PGB-CR , -38.0 % ; 330 mg PGB-CR -43.4 % ) .
RESULTS	Rates of adverse events ( AEs ) were low for placebo and study drug ; the most frequent reported AEs were dizziness , somnolence , and fatigue , consistent with the immediate-release formulation .
CONCLUSIONS	Results from this trial did not demonstrate that PGB-CR is effective in reducing seizure frequency below that of placebo .
CONCLUSIONS	Both doses of PGB-CR were shown to be safe and well-tolerated .

###24860156
BACKGROUND	Administration of supplemental oxygen in the perioperative period is controversial , as it may increase long-term mortality .
BACKGROUND	Our aim was to assess the association between 80 % oxygen and occurrence of subsequent cancer in patients undergoing abdominal surgery in a post hoc analysis of the PROXI trial .
METHODS	The 1386 patients in the PROXI trial underwent elective or emergency laparotomy between 2006 and 2008 with randomization to either 80 % or 30 % oxygen during and for 2 h after surgery .
METHODS	We retrieved follow-up status regarding vital status , new cancer diagnoses , and new histological cancer specimens .
METHODS	Data were analysed using the Cox proportional hazards model .
RESULTS	Follow-up was complete in 1377 patients ( 99 % ) after a median of 3.9 yr .
RESULTS	The primary outcome of new cancer diagnosis or new malignant histological specimen occurred in 140 of 678 patients ( 21 % ) in the 80 % oxygen group vs 150 of 699 patients ( 21 % ) assigned to 30 % oxygen ; hazards ratio 1.06 [ 95 % confidence interval ( CI ) 0.84 , 1.34 ] , P = 0.62 .
RESULTS	Cancer-free survival was significantly shorter in the 80 % oxygen group ; hazards ratio 1.19 ( 95 % CI 1.01 , 1.42 ) , P = 0.04 , as was the time between surgery and new cancer , median 335 vs. 434 days in the 30 % oxygen group .
RESULTS	In patients with localized disease , non-significant differences in cancer and cancer-free survival were found with hazard ratios of 1.31 and 1.29 , respectively .
CONCLUSIONS	Although new cancers occurred at similar rate , the cancer-free survival was significantly shorter in the 80 % oxygen group , but this did not appear to explain the excess mortality in the 80 % oxygen group .
BACKGROUND	ClinicalTrials.gov ( NCT01723280 ) .

###25293480
BACKGROUND	Target-controlled infusion ( TCI ) is used to maintain the desired concentration of a hypnotic drug in the plasma and brain .
BACKGROUND	However , pharmacodynamic variability can cause problems with maintaining the adequate level of anaesthesia .
BACKGROUND	The bispectral index ( BIS ) is one of only a few parameters that allow an assessment of the depth of anaesthesia .
BACKGROUND	In the present study , we attempted to determine the optimal dosages of drugs used for total intravenous anaesthesia with TCI based on BIS-guided monitoring of depth of anaesthesia .
METHODS	The study was conducted in 60 ASA I patients undergoing elective surgery due to lumbar discopathy .
METHODS	The participants were divided into two groups of 30 individuals .
METHODS	The patients were premedicated with 15 mg oral midazolam .
METHODS	Group I was the control group ; group II received BIS monitoring .
METHODS	Anaesthesia was induced with TCI propofol ( 4 mg mL ) , fentanyl ( 2 mg kg ) and vecuronium ( 0.12 mg kg ) and maintained with TCI propofol , continuous infusion of vecuronium ( 0.03 mg kg h ) and fractionated doses of fentanyl .
METHODS	ECG , HR , MAP , SaO , ETCO , and the degree of neuromuscular blockade were monitored , specifically at the following time points : T - before induction , T - after induction , T - after intubation , T - after positioning of the patient , T-T - every 5 min during surgery , T - on completion of surgery , T - before extubation , T - after extubation .
RESULTS	The study groups were comparable in terms of age , body weight , duration of anaesthesia and recovery time .
RESULTS	The haemodynamic parameters , such as HR and MAP , did not differ significantly between the groups .
RESULTS	In both groups , changes in the mean MAP values were observed between T and T , T and T , T and T as well as Tand T.
RESULTS	The total dose of fentanyl and the doses of propofol were lower in the group that received BIS monitoring .
CONCLUSIONS	BIS monitoring reduces the doses of opioids and hypnotics used during total intravenous anaesthesia by TCI .

###24288076
OBJECTIVE	A modified quadrant method was developed for description of femoral tunnel aperture positions on the sagittal plane after double-bundle anterior cruciate ligament ( ACL ) reconstruction , which can be measured by using two-view radiographs .
OBJECTIVE	The purpose of the study is to provide a new measurement method and to evaluate the reproducibility and accuracy of the method .
METHODS	Forty-one patients who had undergone a double-bundle ACL reconstruction were investigated .
METHODS	Two-view plain radiographs , a 45-degree-flexion posterior-anterior standing ( Rosenberg ) and a lateral view , were taken at 1year postoperatively , and the femoral tunnel positions were measured .
METHODS	Intra - and inter-observer reproducibility was calculated by means of intra-class correlation coefficient ( ICC ) .
METHODS	Also , the accuracy of the method was evaluated by comparing the measurement from three-dimensional computed tomography ( 3D-CT ) .
RESULTS	Intra-observer reproducibility was excellent ( ICC > 0.9 ) .
RESULTS	Inter-observer reproducibility of antero-medial ( AM ) tunnel position was almost perfect ( ICC > 0.8 ) and that of postero-lateral ( PL ) tunnel was substantial ( ICC > 0.7 ) .
RESULTS	The accuracy of the method was assessed by comparing the measurement from 3D-CT and was found to be almost perfect ( ICC > 0.8 ) .
RESULTS	With the modified quadrant method , the average height of AM and PL tunnels were 17.8 and 44.4 % , respectively , and the depth of AM and PL tunnels were 25.5 and 36.7 % , respectively .
CONCLUSIONS	A modified quadrant method was found to have acceptable reproducibility and accuracy .
CONCLUSIONS	The method is useful for describing the femoral tunnel aperture positions in ACL reconstruction because of its easiness and simplicity .
CONCLUSIONS	By using this method , it is possible to analyse the femoral tunnel position even in the cases without CT analysis .
METHODS	IV .

###25541647
OBJECTIVE	Platelet endothelial aggregation receptor 1 ( PEAR1 ) is a membrane protein involved in platelet contact-induced activation and sustained platelet aggregation .
OBJECTIVE	Experimental studies identified PEAR1 , as a candidate gene that may be linked to the blood-pressure driven kidney injury in salt-sensitive Dahl rats .
OBJECTIVE	In a family-based European population study ( mean age 39.7 years ; 52.2 % women ) , we searched for association of changes in blood pressure or incidence of hypertension with genetic variation in PEAR1 .
METHODS	Among 1973 randomly recruited people , genotyped for PEAR1 , we measured blood pressure at baseline and follow-up .
RESULTS	Median follow-up was 10.0 years .
RESULTS	While accounting for family clusters and blood pressure at baseline and with adjustments applied for sex , age , body mass index , smoking and drinking , total cholesterol , and antihypertensive drug treatment , all associations of systolic and diastolic blood pressure changes with nine single nucleotide polymorphisms ( SNPs ) in PEAR1 were all non-significant ( p 0.059 ) .
RESULTS	With similar adjustments , the incidence of hypertension ( 397 cases among 1532 participants were normotensive at baseline [ 25.9 % ] ) was not related to the SNPs in PEAR1 ( hazard ratios 1.09 ; p 0.09 ) .
CONCLUSIONS	Our study suggests that PEAR1 is not a hypertension susceptibility gene in humans .

###24932625
BACKGROUND	The statistical analysis of nasal provocation tests is very complex .
BACKGROUND	We compared the conventional analysis with the maximally selected test statistics and the hierarchical ordered logistic model .
METHODS	We re-analyzed data from a trial with 112 patients suffering from grass pollen allergy .
METHODS	The patients had been randomized to receive either intralymphatic immunotherapy ( ILIT ) or subcutaneous immunotherapy ( SCIT ) .
RESULTS	The conventional analysis indicated that the logarithmized ratio between the pre - and the post-treatment threshold concentration was significantly lower for ILIT than for SCIT .
RESULTS	The maximally selected test statistics was used to test different threshold symptom scores that would imply positive clinical symptoms at the given allergen concentration .
RESULTS	A threshold score of 3 maximised the difference in improvement between the ILIT and the SCIT groups .
RESULTS	The hierarchical ordered logistic model does not take threshold allergen concentrations as the basis for analysis , but the single scores measured at each concentration .
RESULTS	This approach simultaneously considers the treatment effect ( ILIT versus SCIT ) , the time effect ( pre - versus post-treatment ) , and the dose effect ( different allergen concentrations ) .
RESULTS	The hierarchical ordered logistic model revealed that the clinical improvement was greater after ILIT than after SCIT .
CONCLUSIONS	As the choice of method can affect the outcome , guidelines for analysis are highly needed .

###24735977
OBJECTIVE	Endothelial function can be assessed by acetylcholine ( ACh ) iontophoresis with single current application .
OBJECTIVE	The effect of inter-electrode distance as well as electrical cutaneous resistance ( ECR ) on ACh dependent vasodilation has never been studied using single current application .
OBJECTIVE	The aims of this study are ( i ) to compare ACh-peak and ECR measured at different inter-electrode distances , ( ii ) to assess the relationship between ACh-peak and ECR , ( iii ) and to study the reproducibility of the ECR values .
METHODS	Fourteen healthy subjects were included .
METHODS	Using laser speckle contrast imaging , ACh-iontophoreses ( 0.1 mA , 30s ) were performed on the forearm at a 7-day interval with an inter-electrode distance set at 5 cm .
METHODS	Two other inter-electrode distances were also evaluated : 10 cm and 15 cm .
METHODS	ECR was measured during each ACh-iontophoresis as well as the ACh-peak .
RESULTS	No statistical difference was found between the ACh-peak values obtained at 5 cm , 10 cm and 15 cm .
RESULTS	ECRs were also not statistically different .
RESULTS	An inverse relationship ( r = -0.60 ) was found between the ACh-peak and ECR ( p < 0.05 ) .
RESULTS	The coefficient of variation of the inter-day reproducibility of the ECR values was 9.1 % [ 6.5 % -15.1 % ] with an intra-class-correlation coefficient of 0.93 [ 0.81-0 .98 ] .
CONCLUSIONS	Inter-electrode distance ranging from 5 cm to 15 cm changes neither the ACh-peak value nor the ECR value .
CONCLUSIONS	ECR impacts ACh-peak values .

###24335446
OBJECTIVE	To evaluate if a family presence educational intervention during brain death evaluation improves understanding of brain death without affecting psychological distress .
METHODS	Randomized controlled trial .
METHODS	Four ICUs at an academic tertiary care center .
METHODS	Immediate family members of patients suspected to have suffered brain death .
METHODS	Subjects were group randomized to presence or absence at bedside throughout the brain death evaluation with a trained chaperone .
METHODS	All randomized subjects were administered a validated `` understanding brain death '' survey before and after the intervention .
METHODS	Subjects were assessed for psychological well-being between 30 and 90 days after the intervention .
RESULTS	Follow-up assessment of psychological well-being was performed using the Impact of Event Scale and General Health Questionnaire .
RESULTS	Brain death understanding , Impact of Event Scale , and General Health Questionnaire scores were analyzed using Wilcoxon nonparametric tests .
RESULTS	Analyses were adjusted for within family correlation .
RESULTS	Fifty-eight family members of 17 patients undergoing brain death evaluation were enrolled : 38 family members were present for 11 brain death evaluations and 20 family members were absent for six brain death evaluations .
RESULTS	Baseline understanding scores were similar between groups ( median 3.0 [ presence group ] vs 2.5 [ control ] , p = 0.482 ) .
RESULTS	Scores increased by a median of 2 ( interquartile range , 1-2 ) if present versus 0 ( interquartile range , 0-0 ) if absent ( p < 0.001 ) .
RESULTS	Sixty-six percent of those in the intervention group achieved perfect postintervention `` understanding '' scores , compared with 20 % of subjects who were not present ( p = 0.02 ) .
RESULTS	Median Impact of Event Scale and General Health Questionnaire scores were similar between groups at follow-up ( Impact of Event Scale : present = 20.5 , absent = 23.5 , p = 0.211 ; General Health Questionnaire : present = 13.5 , absent = 13.0 , p = 0.250 ) .
CONCLUSIONS	Family presence during brain death evaluation improves understanding of brain death with no apparent adverse impact on psychological well-being .
CONCLUSIONS	Family presence during brain death evaluation is feasible and safe .

###24962666
OBJECTIVE	This study was designed to assess the effects of calcium and vitamin D supplementation on the metabolic status of pregnant women with gestational diabetes mellitus ( GDM ) .
METHODS	This randomised placebo-controlled trial was performed at maternity clinics affiliated to Kashan University of Medical Sciences , Kashan , Iran .
METHODS	Participants were 56 women with GDM at 24-28 weeks ' gestation ( 18 to 40 years of age ) .
METHODS	Subjects were randomly assigned to receive calcium plus vitamin D supplements or placebo .
METHODS	All study participants were blinded to group assignment .
METHODS	Individuals in the calcium-vitamin D group ( n = 28 ) received 1,000 mg calcium per day and a 50,000 U vitamin D3 pearl twice during the study ( at study baseline and on day 21 of the intervention ) , and those in the placebo group ( n = 28 ) received two placebos at the mentioned times .
METHODS	Fasting blood samples were taken at study baseline and after 6 weeks of intervention .
RESULTS	The study was completed by 51 participants ( calcium-vitamin D n = 25 , placebo n = 26 ) .
RESULTS	However , as the analysis was based on an intention-to-treat approach , all 56 women with GDM ( 28 in each group ) were included in the final analysis .
RESULTS	After the administration of calcium plus vitamin D supplements , we observed a significant reduction in fasting plasma glucose ( -0.89 0.69 vs +0.26 0.92 mmol/l , p < 0.001 ) , serum insulin levels ( -13.55 35.25 vs +9.17 38.50 pmol/l , p = 0.02 ) and HOMA-IR ( -0.91 1.18 vs +0.63 2.01 , p = 0.001 ) and a significant increase in QUICKI ( +0.02 0.03 vs -0.002 0.02 , p = 0.003 ) compared with placebo .
RESULTS	In addition , a significant reduction in serum LDL-cholesterol ( -0.23 0.79 vs +0.26 0.74 mmol/l , p = 0.02 ) and total cholesterol : HDL-cholesterol ratio ( -0.49 1.09 vs +0.18 0.37 , p = 0.003 ) and a significant elevation in HDL-cholesterol levels ( +0.15 0.25 vs -0.02 0.24 mmol/l , p = 0.01 ) was seen after intervention in the calcium-vitamin D group compared with placebo .
RESULTS	In addition , calcium plus vitamin D supplementation resulted in a significant increase in GSH ( +51.14 131.64 vs -47.27 203.63 mol/l , p = 0.03 ) and prevented a rise in MDA levels ( +0.06 0.66 vs +0.93 2.00 mol/l , p = 0.03 ) compared with placebo .
CONCLUSIONS	Calcium plus vitamin D supplementation in women with GDM had beneficial effects on their metabolic profile .
BACKGROUND	www.irct.ir IRCT201311205623N11 .
BACKGROUND	The study was supported by a grant ( no. 92110 ) from Kashan University of Medical Sciences .

###24246427
BACKGROUND	Daily self-monitoring of diet and physical activity behaviors is a strong predictor of weight loss success .
BACKGROUND	Text messaging holds promise as a viable self-monitoring modality , particularly among racial/ethnic minority populations .
OBJECTIVE	This pilot study evaluated the feasibility of a text messaging intervention for weight loss among predominantly black women .
METHODS	Fifty obese women were randomized to either a 6-month intervention using a fully automated system that included daily text messages for self-monitoring tailored behavioral goals ( eg , 10,000 steps per day , no sugary drinks ) along with brief feedback and tips ( n = 26 ) or to an education control arm ( n = 24 ) .
METHODS	Weight was objectively measured at baseline and at 6 months .
METHODS	Adherence was defined as the proportion of text messages received in response to self-monitoring prompts .
RESULTS	The average daily text messaging adherence rate was 49 % ( SD 27.9 ) with 85 % ( 22/26 ) texting self-monitored behavioral goals 2 or more days per week .
RESULTS	Approximately 70 % ( 16/23 ) strongly agreed that daily texting was easy and helpful and 76 % ( 16/21 ) felt the frequency of texting was appropriate .
RESULTS	At 6 months , the intervention arm lost a mean of 1.27 kg ( SD 6.51 ) , and the control arm gained a mean of 1.14 kg ( SD 2.53 ; mean difference -2.41 kg , 95 % CI -5.22 to 0.39 ; P = .09 ) .
RESULTS	There was a trend toward greater text messaging adherence being associated with greater percent weight loss ( r = -.36 ; P = .08 ) , but this did not reach statistical significance .
RESULTS	There was no significant association between goal attainment and text messaging adherence and no significant predictors of adherence .
CONCLUSIONS	Given the increasing penetration of mobile devices , text messaging may be a useful self-monitoring tool for weight control , particularly among populations most in need of intervention .
BACKGROUND	Clinicaltrials.gov : NCT00939081 ; http://clinicaltrials.gov/show/NCT00939081 ( Archived by WebCite at http://www.webcitation.org/6KiIIcnk1 ) .

###24642828
BACKGROUND	Mannitol and hypertonic saline ( HS ) are routinely used during craniotomy .
BACKGROUND	Both increase myocardial preload and reduce afterload , and may improve cardiac output .
BACKGROUND	It is not currently known whether this results in an improvement in the global myocardial function .
BACKGROUND	Thus , the aim of this study was to compare the effects of a single equiosmolar bolus of 20 % mannitol ( 5 mL/kg ) or 3 % HS ( 5 mL/kg ) on the global myocardial function by tissue Doppler-derived myocardial performance index ( TD-MPI ) in patients undergoing craniotomy .
METHODS	Fifty adult patients were included and randomized to receive either mannitol or 3 % HS .
METHODS	Transesophageal echocardiography was performed in all patients .
METHODS	Early ( E ) and late ( A ) peak mitral inflow velocity , early diastolic mitral annular velocity ( E prime ) , isovolumetric relaxation time ( IVRT ) , ejection time ( ET ) , and isovolumetric contraction time ( IVCT ) were recorded at baseline and at 15 , 30 , 60 , and 120 minutes after administration of the hyperosmolar solutions .
METHODS	TD-MPI was calculated as IVRT+IVCT / ET .
RESULTS	There were no significant differences in the TD-MPI ( HS vs. mannitol : 0.43 vs. 0.44 [ baseline ] , 0.45 vs. 0.43 [ 15 min ] , 0.44 vs. 0.45 [ 30 min ] , 0.47 vs. 0.45 [ 60 min ] , 0.45 vs. 0.46 [ 120 min ] ) , E/A ratio , IVCT , and E/E ' either within or between the 2 groups at any time point .
RESULTS	IVRT was prolonged in HS group as compared with baseline at 15 , 30 , and 60 minutes postinfusion .
RESULTS	ET was decreased in both the groups at 120 minutes postinfusion .
RESULTS	Neither of these altered the TD-MPI .
CONCLUSIONS	Equiosmolar administration of 20 % mannitol and 3 % HS did not show any difference in global myocardial performance as measured by TD MPI .

###24821891
OBJECTIVE	Interventions tailored to sociopsychological factors associated with health behaviors have promise for reducing colorectal cancer screening disparities , but limited research has assessed their impact in multiethnic populations .
OBJECTIVE	We examined whether an interactive multimedia computer program ( IMCP ) tailored to expanded health belief model sociopsychological factors could promote colorectal cancer screening in a multiethnic sample .
METHODS	We undertook a randomized controlled trial , comparing an IMCP tailored to colorectal cancer screening self-efficacy , knowledge , barriers , readiness , test preference , and experiences with a nontailored informational program , both delivered before office visits .
METHODS	The primary outcome was record-documented colorectal cancer screening during a 12-month follow-up period .
METHODS	Secondary outcomes included postvisit sociopsychological factor status and discussion , as well as clinician recommendation of screening during office visits .
METHODS	We enrolled 1,164 patients stratified by ethnicity and language ( 49.3 % non-Hispanic , 27.2 % Hispanic/English , 23.4 % Hispanic/Spanish ) from 26 offices around 5 centers ( Sacramento , California ; Rochester and the Bronx , New York ; Denver , Colorado ; and San Antonio , Texas ) .
RESULTS	Adjusting for ethnicity/language , study center , and the previsit value of the dependent variable , compared with control patients , the IMCP led to significantly greater colorectal cancer screening knowledge , self-efficacy , readiness , test preference specificity , discussion , and recommendation .
RESULTS	During the followup period , 132 ( 23 % ) IMCP and 123 ( 22 % ) control patients received screening ( adjusted difference = 0.5 percentage points , 95 % CI -4.3 to 5.3 ) .
RESULTS	IMCP effects did not differ significantly by ethnicity/language .
CONCLUSIONS	Sociopsychological factor tailoring was no more effective than nontailored information in encouraging colorectal cancer screening in a multiethnic sample , despite enhancing sociopsychological factors and visit behaviors associated with screening .
CONCLUSIONS	The utility of sociopsychological tailoring in addressing screening disparities remains uncertain .

###25770644
BACKGROUND	Postoperative emergency agitation ( EA ) is a common problem often observed in children undergoing general anesthesia .
BACKGROUND	The purpose of this study was to evaluate whether a bolus of intraoperative low-dose ketamine followed by dexmedetomidine i.v. could reduce the incidence of EA in children undergoing adenotonsillectomy following sevoflurane-based anesthesia .
METHODS	A total of 92 children undergoing adenotonsillectomy , aged 3-7 years , were randomly allocated to receive either low-doseketamine 0.15 mg/kg followed by dexmedetomidine 0.3 g/kg i.v. ( KETODEX , n = 45 ) or volume-matched normal saline ( Control , n = 47 ) , about 10 min before the end of surgery .
METHODS	Anesthesia was induced and maintained with sevoflurane .
METHODS	Postoperative pain and EA were assessed with objective pain score ( OPS ) and the Pediatric Anesthesia Emergence Delirium scale ( PAED ) , respectively .
METHODS	EA was defined as a PAED10 points .
METHODS	Recovery profile and postoperative complications were recorded .
RESULTS	The incidence and severity of EA was lower in KETODEX group than controls ( 11 % vs. 47 % ) and ( 2 % vs. 13 % ) , respectively ( P < 0.05 ) .
RESULTS	The frequency of fentanyl rescue was lower in KETODEX group than in controls ( 13.3 vs. 38.3 % , P < 0.05 ) .
RESULTS	Heart rate during extubation was significantly higher in the control group compared with children who received KETODEX ( P < 0.05 ) .
RESULTS	The incidence of postoperative pain was significantly less in the KETODEX group ( 15.5 % vs. 63.8 % , P < 0.05 ) .
RESULTS	Times to interaction and extubation were significantly longer in the KETODEX group ( P < 0.05 ) .
CONCLUSIONS	KETODEX reduces the incidence and severity of EA in children undergoing adenotonsillectomy following sevoflurane-based anesthesia and provided smooth extubation .

###24365607
BACKGROUND	The purpose of this study was to evaluate if ultrasound derived measures of diaphragm thickening , rather than diaphragm motion , can be used to predict extubation success or failure .
METHODS	Sixty-three mechanically ventilated patients were prospectively recruited .
METHODS	Diaphragm thickness ( tdi ) was measured in the zone of apposition of the diaphragm to the rib cage using a 7-10 MHz ultrasound transducer .
METHODS	The percent change in tdi between end-expiration and end-inspiration ( tdi % ) was calculated during either spontaneous breathing ( SB ) or pressure support ( PS ) weaning trials .
METHODS	A successful extubation was defined as SB for > 48 h following endotracheal tube removal .
RESULTS	Of the 63 subjects studied , 27 patients were weaned with SB and 36 were weaned with PS .
RESULTS	The combined sensitivity and specificity of tdi % 30 % for extubation success was 88 % and 71 % , respectively .
RESULTS	The positive predictive value and negative predictive value were 91 % and 63 % , respectively .
RESULTS	The area under the receiver operating characteristic curve was 0.79 for tdi % .
CONCLUSIONS	Ultrasound measures of diaphragm thickening in the zone of apposition may be useful to predict extubation success or failure during SB or PS trials .

###25499208
BACKGROUND	The Spine Patient Outcomes Research Trial ( SPORT ) is a highly referenced clinical trial that randomized patients with lumbar pathology to receive surgery or continued conservative treatment .
OBJECTIVE	The purpose of this study was to compare the SPORT lumbar disc herniation cohort and an analogous cohort from the National Surgical Quality Improvement Program ( NSQIP ) database .
METHODS	This is a retrospective cohort study comparing a national database population to a randomized clinical trial .
METHODS	Elective lumbar discectomies from NSQIP between 2010 and 2012 were used .
METHODS	Demographics were compared between the randomized SPORT cohorts ( surgical and nonoperative ) and NSQIP .
METHODS	Perioperative factors and complications were then compared between SPORT discectomy patients and NSQIP .
METHODS	Using current procedural terminology and International Classification of Diseases , ninth revision codes , all elective lumbar discectomies from NSQIP between 2010 and 2012 were identified .
METHODS	Where possible based on the published data and variables available in each cohort , the two populations were compared .
RESULTS	A total of 6,846 NSQIP discectomy patients were compared with the randomized SPORT surgical and nonoperative cohorts .
RESULTS	Demographic comparisons showed that NSQIP patients were older ( average age 48.214.5 years [ meanstandard deviation ] vs. 41.711.8 and 43.011.3 years , respectively [ p < .001 ] ) and had higher body mass index ( 29.66.2 kg/m ( 2 ) vs. 27.85.6 and 28.25.4 kg/m ( 2 ) , respectively [ p < .001 ] ) .
RESULTS	No statistical differences existed for gender or race .
RESULTS	Smoking status was not different between the SPORT nonoperative group and NSQIP but was higher in NSQIP compared with SPORT surgical patients ( p = .020 by 7 % ) .
RESULTS	Comparisons of perioperative factors and complications between the SPORT surgical cohort and NSQIP showed no statistical difference in average operative time , length of stay , deep wound infections , wound dehiscence , total wound complications , or blood transfusions .
RESULTS	Spine Patient Outcomes Research Trial superficial wound infection rates were higher than NSQIP ( p = .029 by 1.4 % ) .
RESULTS	As expected , SPORT 1-year reoperation rates were higher than NSQIP 30-day rates ( 7 % vs. 2 % , p < .001 ) .
CONCLUSIONS	Spine Patient Outcomes Research Trial lumbar disc herniation results are similar to those from a large national patient sample .
CONCLUSIONS	Even statistically significant differences would be considered clinically similar .
CONCLUSIONS	These findings support the generalizability of the SPORT lumbar disc herniation results .

###25247957
OBJECTIVE	Transverse sinus stenosis is an imaging finding very highly associated with elevated intracranial pressure ( ICP ) .
OBJECTIVE	Patients with the Chiari I malformation may potentially have elevated ICP due to impairment of CSF flow at the foramen magnum .
OBJECTIVE	This study evaluated whether patients with Chiari I malformation have transverse sinus stenosis and other imaging findings indicative of elevated ICP .
METHODS	Thirty patients with Chiari I malformation treated surgically and 76 control subjects were identified retrospectively .
METHODS	All control subjects and all patients with Chiari I malformation ( preoperatively ) underwent standardized contrast-enhanced brain MRI including a contrast-enhanced 3D T1-weighted sequence from which curved reformats of the transverse sinuses were generated .
METHODS	Two different readers blinded to the diagnosis then independently evaluated these curved reformats for severity of transverse sinus stenosis .
METHODS	Orbital and skull-base findings previously described in association with elevated ICP were also evaluated .
METHODS	Frequency of MRI findings between the two groups was compared .
RESULTS	Patients with Chiari I malformation had significantly greater frequency of unilateral or bilateral transverse sinus stenosis than did control subjects ( p < 0.001 ) .
RESULTS	There was complete interreader agreement on presence or absence of transverse sinus stenosis by patient ( = 1.0 [ 95 % CI , 0.89-1 .0 ] ) .
RESULTS	Logistic regression analysis controlling for age , sex , and body mass index found that transverse sinus stenosis significantly predicted Chiari I malformation versus control status ( odds ratio , 11.2 [ 95 % CI , 2.1-59 .0 ] ; p = 0.004 ) but that no other features were significantly associated with the Chiari I malformation .
RESULTS	Patients with Chiari I malformation who had transverse sinus stenosis had significantly greater pituitary flattening than did those without transverse sinus stenosis ( p = 0.02 ) .
CONCLUSIONS	Patients with Chiari I malformation have higher likelihood of transverse sinus stenosis , which may reflect associated elevated ICP .

###25099071
BACKGROUND	Cardiovascular diseases have become the leading cause of death from chronic diseases in the world .
BACKGROUND	Main risk factors include hypercholesterolemia , which is caused in most cases by a high saturated fat diet .
BACKGROUND	Plant stanol esters partly block cholesterol absorption in the digestive tract and thereby reduce total cholesterol and low-density lipoprotein ( LDL ) cholesterol serum levels .
BACKGROUND	Based on epidemiological data , a 10 percent reduction of LDL cholesterol leads to a 20 percent decrease in the coronary heart disease risk throughout life .
BACKGROUND	The aim of this study was to evaluate the efficacy of yogurt drink with added plant stanol esters ( Benecol yogurt drink ) in higher doses than the typically used ( 2g/d stanols ) , in lowering blood lipids in moderately hypercholesterolemic subjects .
METHODS	A randomized double-blind crossover , placebo-controlled study in moderately hypercholesterolemic subjects ( n = 40 ) aged between 20 and 50years old .
RESULTS	Yogurt drink with added plant stanols ( 4g ) as esters ( Benecol , Colanta ) consumption compared to regular yogurt drink caused a statistically significant decrease in total cholesterol and low density lipoprotein cholesterol by 7.2 % and 10.3 % .
RESULTS	During the two periods and compared to controls , high-density lipoprotein cholesterol and triglycerides were not significantly different .
CONCLUSIONS	Yogurt drink with an active ingredient in Benecol , plant stanol esters , reduced total cholesterol and LDL cholesterol in moderately hypercholesterolemic subjects .
BACKGROUND	NCT01461798 .

###25146603
BACKGROUND	Traditional Chinese medical treatment of primary Sjgren 's syndrome has advantages over Western medicine in terms of fewer side effects and improved patient conditions .
BACKGROUND	This study was a multicenter , randomized , double-blind , placebo-controlled clinical trial of the efficacy and safety of ShengJinRunZaoYangXue granules for the treatment of primary Sjgren 's syndrome , including the symptoms of dry mouth and dry eye .
METHODS	We undertook a 6-week , double-blind , randomized trial involving 240 patients with primary Sjgren 's syndrome at five centers in East China .
METHODS	A computer-generated randomization schedule assigned patients at a 2:1 ratio to receive either ShengJinRunZaoYangXue granules or placebo once daily .
METHODS	Patients and investigators were blinded to treatment allocation .
METHODS	The primary endpoints were the salivary flow rate , Schirmer test results , and sugar test results .
METHODS	Intention-to-treat and per-protocol analyses were performed .
RESULTS	All 240 patients were randomly allocated to either the treatment group ( n = 160 , ShengJinRunZaoYangXue granules ) or placebo group ( n = 80 ) and were included in the intention-to-treat analysis .
RESULTS	After program violation and loss to follow-up , a total of 199 patients were included in the per-protocol analysis .
RESULTS	At six week , intention-to-treat and per-protocol analyses of the left-eye Schirmer I test results showed an improved difference of 1.36 mm/5 min ( 95 % CI : 0.03 to 2.69 mm/5 min ) and 1.35 mm/5 min ( 95 % CI : 0.04 to 2.73 mm/5 min ) , respectively , and those of the right-eye Schirmer I test results showed an improved difference of 1.12 mm/5 min ( 95 % CI : 0.02 to 2.22 mm/5 min ) and 1.12 mm/5 min ( 95 % CI : -0.02 to 2.27 mm/5 min ) , respectively .
RESULTS	There was no significant difference between the two groups before treatment .
RESULTS	After treatment , the between-group and within-group before-and-after paired comparison results were statistically significant ( P < 0.05 ) .
RESULTS	Intention-to-treat and per-protocol analyses showed an improved salivary flow rate by 0.04 ml/15 min ( 95 % CI : -0.49 to 0.58 ml/15 min ) and 0.04 ml/15 min ( 95 % CI : -0.52 to 0.60 ml/15 min ) , respectively , but the differences were not significant .
RESULTS	Intention-to-treat and per-protocol analyses showed that the sugar test results were improved by 1.77 minutes ( 95 % CI : 0.11 to 3.44 minutes ) and 1.84 minutes ( 95 % CI : 0.12 to 3.55 minutes ) , respectively , but the differences were not significant .
RESULTS	For the secondary endpoint , intention-to-treat and per-protocol analyses showed significant improvement in the integrated evaluation of treated patients with dry eye and dry mouth after six weeks of treatment .
RESULTS	The incidence of adverse events was 15.6 % in the treatment group and 10.0 % in the placebo group .
RESULTS	Most ( 94 % ) adverse events were mild to moderate in the two groups , and only two cases of serious adverse events occurred in the treatment group ; both were caused by autoimmune liver disease .
CONCLUSIONS	Six-week treatment with ShengJinRun ZaoYangXue granules for primary Sjgren 's syndrome in this large-scale study improved the symptoms of dry mouth , dry eyes , and low tear flow rate with minimal adverse events .

###24332919
OBJECTIVE	Endovascular aortic aneurysm repair ( EVAR ) may result in deterioration of renal function .
OBJECTIVE	Mannitol has renovascular and antioxidant properties that could prove beneficial in this respect .
METHODS	A randomized prospective study .
METHODS	Attikon University Hospital , single institution .
METHODS	Eighty-six patients undergoing elective EVAR under regional anesthesia .
METHODS	Patients received hydration alone ( controls ) or hydration plus mannitol ( 0.5 g/kg ) .
RESULTS	Creatinine , serum cystatin-C , urine neutrophil-gelatinase-associated lipocalin ( NGAL ) , albuminuria and serum urea were measured 24 hours and 72 hours after the procedure ( baseline NGAL was measured in 19 randomly selected patients ) .
RESULTS	Serum creatinine also was measured at the followup of the patients .
RESULTS	Serum creatinine and cystatin-C were lower in the mannitol group at 24 hours postoperatively ( creatinine , mannitol [ n = 43 ] ; 1.070.26 [ CI95 % : 0.99-1 .15 ] v controls [ n = 43 ] ; 1.200.30 [ CI95 % : 1.11-1 .30 ] ) , but not at 72 hours ( creatinine , mannitol [ n = 43 ] ; 1.130.29 [ CI95 % : 1.04-1 .22 ] v controls [ n = 43 ] ; 1.260.41 [ CI95 % 1.15-1 .38 ] ) .
RESULTS	Urine NGAL increased substantially at 24 hours without differences between groups .
RESULTS	At followup ( controls : 137 months ; mannitol : 127 months ) , there were no differences between creatinine or creatinine clearance ( creatinine : controls [ n = 28 ] ; 1.150.39 [ CI95 % 1.02-1 .29 ] v mannitol [ n = 23 ] ; 1.050.27 [ CI95 % : 0.95-1 .17 ] ) .
RESULTS	The overall changes of creatinine and creatinine clearance with time were significant in controls but not in the mannitol group .
RESULTS	The classification according to the RIFLE criteria yielded 4 patients at risk for renal injury and 2 with renal injury in the control group and 6 patients at risk with no patients with injury in the mannitol group , but the difference of renal dysfunction between the 2 groups was not statistically significant .
CONCLUSIONS	Mannitol plus hydration during EVAR provides a small but significant benefit for renal function .
CONCLUSIONS	Future preventive protocols aiming at greater restoration of renal function after EVAR could include mannitol as a useful component .

###24395298
OBJECTIVE	The aim of this study was to compare the effects of concomitant administration of alcohol and bilastine versus alcohol alone on the central nervous system .
METHODS	Twenty-four healthy young volunteers of both sexes participated in a randomized , double-blind , double-dummy , crossover , and positive-controlled and placebo-controlled clinical trials .
METHODS	At 1-week intervals , subjects received six different treatments : ( i ) placebo ; ( ii ) alcohol 0.8 g/kg alone ( ALC ) ; ( iii ) ALC in combination with : bilastine 20mg ( B20 + A ) ; ( iv ) bilastine 80mg ( B80 + A ) ; ( v ) cetirizine 10mg ( CET+A ) ; and ( vi ) hydroxyzine 25mg ( HYD+A ) .
METHODS	Psychomotor performance tests ( fine motor , finger tapping , nystagmus , critical flicker-fusion frequency , temporal estimation , 'd 2 ' cancellation , and simple reaction time ) and subjective self-reports ( drunkenness , drowsiness , mental slowness , clumsiness , anger , attentiveness , competence , happiness , hostility , interest , and extroversion ) were carried out at baseline and multiple points thereafter .
RESULTS	All active treatments induced a significant psychomotor impairment .
RESULTS	The greatest and most lasting impairment was observed with HYD+A followed by B80 + A and CET+A .
RESULTS	In contrast , objective measures showed less impairment with B20 + A and ALC , both with a similar magnitude .
RESULTS	Self-reports showed a subjective perception of performance impairment in all active treatments .
CONCLUSIONS	Concomitant administration of bilastine ( at therapeutic dose ) and alcohol does not produce greater central nervous system depressant effects than ACL alone .

###24728866
BACKGROUND	Laparoscopic sleeve gastrectomy ( LSG ) is a surgical technique that treats morbid obesity .
METHODS	Consecutive patients with morbid obesity treated by LSG at our department were evaluated .
METHODS	Patients enrolled in the study were randomized into group I ( LSG begins the division 2 cm from the pylorus ) and group II ( LSG begins the division 6 cm from the pylorus ) .
METHODS	The primary outcome measure was the percent of excess weight loss ( % EWL ) ; secondary outcomes included postoperative morbidity and mortality and improvement of comorbidity .
RESULTS	One hundred five patients ( 79 ( 75.2 % ) were females ) were randomized into two groups of ( GI ) 52 patients and ( GII ) 53 patients .
RESULTS	In group I , the mean % EWL was 51.813.9 , 63.816.1 and 71.812 ; however , in group II , the mean % EWL was 38.310.9 , 51.913.6 and 6111.1 at 6 , 12 , and 24 months , respectively ( P = 0.0001 , 0.0001 , 0.003 ) .
RESULTS	There was weight regain after 2 years in five patients in group II and only one patient in group I ( P = 0.09 ) .
RESULTS	There was no significant difference between both group as regards gastric leakage , vomiting or GER .
RESULTS	There was significant improvement in comorbidity after LSG in both groups , but no significant difference between them .
RESULTS	Hospital mortality occurred in group II in one case as a result of gastric leakage .
CONCLUSIONS	LSG is a safe and effective procedure with good short-term outcome .
CONCLUSIONS	Increasing the size of the resected antrum is associated with better weight loss without increasing the rate of complications significantly .

###25008439
BACKGROUND	Topical 5 % 5-fluorouracil ( 5-FU ) is known to cause toxicity , such as erythema , pain , and crusting/erosions .
OBJECTIVE	We sought to develop a scale to measure this toxicity and test the scale for reliability .
METHODS	A scale was developed involving four parameters : erythema severity , percentage of face involved in erythema , crusting/erosions severity , and percentage of face involved in crusting/erosions .
METHODS	Thirteen raters graded 99 sets of photographs from the Veterans Affairs Keratinocyte Carcinoma Chemoprevention ( VAKCC ) Trial using these parameters .
RESULTS	Intraclass correlation overall for 13 raters was 0.82 ( 95 % CI 0.77-0 .86 ) .
RESULTS	There was no statistically significant trend in reliability by level of training in dermatology .
CONCLUSIONS	This scale is a reliable method of evaluating the severity of toxicity from topical 5-fluorouracil and can be used by dermatologists and nondermatologists alike .

###25979614
OBJECTIVE	Preterm rupture of membranes ( PROM ) is associated with an increased risk of preterm birth and neonatal morbidity .
OBJECTIVE	Prophylactic 17-hydroxyprogesterone caproate ( 17OHP-C ) reduces the risk of preterm birth in some women who are at risk for preterm birth .
OBJECTIVE	We sought to test whether 17OHP-C would prolong pregnancy or improve perinatal outcome when given to mothers with preterm rupture of the membranes .
METHODS	This is a multicenter , double-blind , placebo-controlled , randomized clinical trial .
METHODS	The study included singleton pregnancies with gestational ages from 23 ( 0/7 ) to 30 ( 6/7 ) weeks at enrollment , documented PROM , and no contraindication to expectant management .
METHODS	Consenting women were assigned randomly to receive weekly intramuscular injections of 17OHP-C ( 250 mg ) or placebo .
METHODS	The primary outcome was continuation of pregnancy until a favorable gestational age , which was defined as either 34 ( 0/7 ) weeks of gestation or documentation of fetal lung maturity at 32 ( 0/7 ) to 33 ( 6/7 ) weeks of gestation .
METHODS	The 2 prespecified secondary outcomes were interval from randomization to delivery and composite adverse perinatal outcome .
METHODS	The planned sample size was 222 total women .
RESULTS	From October 2011 to April 2014 , 152 women were enrolled ; 74 women were allocated randomly to 17OHP-C , and 78 were allocated randomly to placebo .
RESULTS	The trial was stopped when results of a planned interim analysis suggested that continuation was futile .
RESULTS	The primary outcome was achieved in 3 % of the 17OHP-C group and 8 % of the placebo group ( P = .18 ) .
RESULTS	There was no significant between-group difference in the prespecified secondary outcomes , randomization-to-delivery interval ( 17.1 16.1 vs 17.0 15.8 days , respectively ; P = .76 ) or composite adverse perinatal outcome ( 63 % vs 61 % , respectively ; P = .93 ) .
RESULTS	No significant differences were found in other outcomes , which included rates of chorioamnionitis , postpartum endometritis , cesarean delivery , individual components of the composite outcome , or prolonged neonatal length of stay .
CONCLUSIONS	Compared with placebo , weekly 17OHP-C injections did not prolong pregnancy or reduce perinatal morbidity in patients with PROM in this trial .

###24877660
OBJECTIVE	The aim of the study was to examine the long-term effect of commonly used whole soy foods ( soy flour ) and purified daidzein ( one major isoflavone and the precursor of equol ) on renal function among prehypertensive postmenopausal women who are also equol producers , a population most likely to benefit from soy intervention .
METHODS	This was a 6-month double-blind , randomized , placebo-controlled trial .
METHODS	Two hundred seventy eligible Chinese women were randomized to either one of the three treatments : 40 g soy flour ( whole soy group ) , 40 g low-fat milk powder + 63 mg daidzein ( daidzein group ) or 40 g low-fat milk powder ( placebo group ) daily each for 6 months .
METHODS	Fasting blood and 24-h urine samples were collected at the beginning and end of trial .
METHODS	Serum creatinine , cystatin C , urea , angiotensin-converting enzyme , minerals and 24-h urinary creatinine and minerals were analyzed .
METHODS	Estimated glomerular filtration rate ( eGFR ) was calculated with the Cockcroft-Gault and the Chronic Kidney Disease Epidemiology Collaboration ( CKD-EPI ) equations .
RESULTS	Two hundred fifty-three subjects completed the study according to the protocol .
RESULTS	Urinary isoflavones indicated good compliance of participants .
RESULTS	No significant changes were observed in most of renal parameters , however , there was a less decrease in eGFRcockcroft in 6-month change ( p = 0.044 ) and % change ( p = 0.031 ) with whole soy intake relative to milk placebo .
RESULTS	Subgroup analysis among women with lowered renal function suggested whole soy consumption tended to improve markers of renal function relative to control .
CONCLUSIONS	Six-month consumption of whole soy tended to have a modest improvement of renal function in prehypertensive postmenopausal women with lowered renal function .
CONCLUSIONS	Future trials in subjects with more declined renal function are necessary .
BACKGROUND	The trial was registered in ClinicalTrials.gov with identifier of NCT01270737 .
BACKGROUND	( URL : http://clinicaltrials.gov/ct2/show/NCT01270737 ) .

###26317254
BACKGROUND	Measure of arterial stiffness could be affected by the presence of abdominal aortic aneurysm ( AAA ) and especially an intraluminal thrombus ( ILT ) .
BACKGROUND	We , therefore , sought to study this possible connection by measuring pulse wave velocity ( PWV ) and pulse wave analysis ( PWA ) including augmentation index adjusted to heart rate 75 ( Aix75 ) in patients with AAA ILT .
METHODS	PWV and PWA were measured in male patients with AAA from an ongoing Danish AAA screening trial .
METHODS	Information on blood pressure , medications , BMI and smoking status was obtained at inclusion .
RESULTS	In total , 157 patients were included .
RESULTS	Mean age was 73 years .
RESULTS	Mean AAA size was 42.2 mm .
RESULTS	Fifty-six of the patients had an intraluminal thrombus , and patients with AAA and ILT had a significantly higher Aix75 than patients with AAA but without ILT ( Mean = 28.3 1.4 SEM vs. 24.9 0.81 , p = 0.027 ) , a difference that was also significant when adjusting for AAA size , blood pressure and age .
RESULTS	There was no difference in PWV between the groups .
CONCLUSIONS	Haemodynamic properties of the aorta are affected by the presence of ILT in patients with AAA that is not explained by aortic size .
CONCLUSIONS	Alternatively , these findings could be explained by associations between ILT and properties of the left ventricle .

###24323667
OBJECTIVE	The aim of this study was to evaluate the safety and efficacy of the GORE ( ) Septal Occluder ( GSO ) at 1 - , 6 - , and 12-month follow-up in patients with a clinical indication for patent foramen ovale ( PFO ) closure .
BACKGROUND	Limited data are available regarding the safety and efficacy of the GSO for PFO closure .
METHODS	Sixty consecutive patients with an embolic event , migraine , or risk of decompression sickness were enrolled .
METHODS	Transesophageal or transthoracic echocardiography and clinical follow-up were performed at 1 , 6 and 12 months after implantation .
METHODS	All patients received 100 mg aspirin and 75 mg clopidogrel for 6 months .
RESULTS	Procedures were technically successful in 98.3 % ( 59/60 ) .
RESULTS	In one case , the anterior interatrial septal rim proved too short to allow safe GSO implantation and , instead , a different occluder was implanted .
RESULTS	One patient developed transient neurological symptoms during the procedure without evidence for a stroke by magnetic resonance imaging .
RESULTS	At 6-month follow-up , the closure rate was 86.6 % ( 52/60 ) .
RESULTS	The complete closure rate after 1 year was 93.3 % ( 56/60 ) .
RESULTS	Stroke , thrombus formation and atrial fibrillation ( AF ) / flutter occurred in 1 ( 1.7 % ) , 1 ( 1.7 % ) , and 5 ( 8.3 % ) patients , respectively .
CONCLUSIONS	PFO closure with the GSO is accompanied by a high technical success rate and closure rates similar to other currently used devices .
CONCLUSIONS	The incidence of AF was higher than reported with most other devices .
CONCLUSIONS	This may be a chance finding but warrants further investigation in larger trials .

###25575875
BACKGROUND	Patients with malignant pleural mesothelioma ( MPM ) may develop painful ` procedure tract metastasis ' ( PTM ) at the site of previous pleural interventions .
BACKGROUND	Prophylactic radiotherapy has been used to minimise this complication ; however , three small randomised trials have shown conflicting results regarding its effectiveness .
BACKGROUND	The surgical and large bore procedures in malignant pleural mesothelioma and radiotherapy trial ( SMART Trial ) is a suitably powered , multicentre , randomised controlled trial , designed to evaluate the efficacy of prophylactic radiotherapy within 42days of pleural instrumentation in preventing the development of PTM in MPM .
METHODS	203 patients with a histocytologically proven diagnosis of MPM , who have undergone a large bore pleural intervention ( thoracic surgery , large bore chest drain , indwelling pleural catheter or local anaesthetic thoracoscopy ) in the previous 35days , will be recruited from UK hospitals .
METHODS	Patients will be randomised ( 1:1 ) to receive immediate radiotherapy ( 21Gy in 3 fractions over 3 working days within 42days of the pleural intervention ) or deferred radiotherapy ( 21Gy in 3 fractions over 3 working days given if a PTM develops ) .
METHODS	Patients will be followed up for 12months .
METHODS	The primary outcome measure is the rate of PTM until death or 12months ( whichever is sooner ) , as defined by the presence of a clinically palpable nodule of at least 1cm diameter felt within 7cm of the margins of the procedure site as confirmed by two assessors .
METHODS	Secondary outcome measures include chest pain , quality of life , analgaesic requirements , healthcare utilisation and safety ( including radiotherapy toxicity ) .
BACKGROUND	The trial has received ethical approval from the Southampton B Research Ethics Committee ( 11/SC/0408 ) .
BACKGROUND	There is a Trial Steering Committee , including independent members and a patient and public representative .
BACKGROUND	The trial results will be published in a peer-reviewed journal and presented at international conferences .
BACKGROUND	ISRCTN72767336 .

###24885187
BACKGROUND	Preoperative therapy with chemotherapy and the HER2-targeted monoclonal antibody trastuzumab is valuable for patients with large or locally advanced HER2-positive ( HER2 + ) breast cancers but traditional methods of measuring HER2 expression do not accurately stratify patients for likelihood of response .
BACKGROUND	Quantitative immunofluorescent approaches have the potential to provide a mathematically continuous measure of HER2 .
BACKGROUND	Here we seek to determine whether quantitative measurement of HER2 or phospho-HER2 correlates with likelihood of response to trastuzumab - containing neoadjuvant therapy .
METHODS	We evaluated core biopsy samples from 27 HER2 + breast cancer patients enrolled in a preoperative clinical trial using trastuzumab , nab-paclitaxel and carboplatin combination therapy ( BrUOG BR-211B ( NCT00617942 ) ) .
METHODS	Tumor core biopsies were taken before initiation of treatment and 9-13 days after patients received `` run-in '' doses of either single agent trastuzumab or nab-paclitaxel .
METHODS	The AQUA method of quantitative immunofluorescence was used for analysis of in situ protein expression .
METHODS	Patients then received 18weeks of treatment , followed by surgery to assess pathologic response to the neoadjuvant regimen .
RESULTS	A HER2 score of 2111 by AQUA analysis has been shown to be equivalent to HER2 3 + by immunohistochemical staining in previous studies .
RESULTS	Of 20 evaluable patients , 10 cases who achieved a pathologic complete response ( pathCR ) with neoadjuvant treatment had a mean HER2 level of 10251 compared with 4766 in the patients without pathCR ( p = 0.0021 ) .
RESULTS	Measurement of phospho-HER2 showed no difference in pathCR vs non-pathCR groups .
RESULTS	In 9 patients who had HER2 levels repeated after a single treatment with trastuzumab there was no evidence of a reduction in the HER2 or phospho-HER2 levels following that exposure .
CONCLUSIONS	High levels of HER2 are associated with achievement of a pathCR in the preoperative setting , while levels of Phospho-HER2 were not predictive of response .
CONCLUSIONS	This data suggests that accurate measurement of HER2 may help determine the likelihood of response in the pre-surgical setting .
CONCLUSIONS	Further validation in larger cohorts is required , but this pilot data shows the feasibility of this approach .

###25274252
BACKGROUND	Exercise related leg pain ( ERLP ) is a common lower limb overuse injury characterised by pain located between the knee and ankle that occurs during activity .
BACKGROUND	The high incidence of the condition , subsequent interference with participation in physical activity and substantial recovery time , highlights a need for effective interventions .
BACKGROUND	Whilst many interventions have been described for the management of ERLP , currently there is a lack of high quality evidence for an effective intervention for the condition .
METHODS	A single-blinded randomised controlled clinical trial will be conducted in a community setting .
METHODS	Forty-five female volunteers aged between 18 and 40years with a history of insidious onset of pain located between the knee and ankle of at least one month duration that is aggravated by weight bearing activities will be recruited for the study .
METHODS	Suitable participants will be randomly allocated to one of three treatment groups for the 6week intervention period : ( i ) exercise only , ( ii ) rigid anti-pronation tape and exercise , ( iii ) elastic anti-pronation tape and exercise .
METHODS	Outcomes will be measured at baseline , 1 , 2 and 6 weeks using primary outcome measures of usual and worst pain visual analogue scale and global perceived improvement .
METHODS	Secondary outcome measures will include Foot and Ankle Ability Measure , Patient Specific Functional Scale and amount of activity in the previous week .
METHODS	In addition , participants will be contacted by phone to obtain primary and secondary outcome measures at 12 , 18 , 24 and 30weeks .
CONCLUSIONS	This article describes a single-blinded randomised controlled clinical trial that will utilise high quality methodologies in accordance with CONSORT guidelines .
CONCLUSIONS	The results of this study will contribute to the limited knowledge regarding effective interventions for the management of ERLP .
BACKGROUND	Australian New Zealand Clinical Trials Registry ( ACTRN12613000914763 ) .

###25306681
OBJECTIVE	To assess efficacy and safety of dexmedetomidine for treatment of delirium in cardiac surgery .
METHODS	We performed an open , prospective comparative study in 60 patients , who received surgery on the heart or major vessels under general anaesthesia .
METHODS	In the early postoperative period , all patients suffered from delirium .
METHODS	All patients were divided into two groups .
METHODS	The patients in group-I ( 30 patients ) received dexmedetomidine ( 0.2-1 .4 mcg/kg / hour ) , 20 of them received dexmedetomidine only and 10 received a combination of dexmedetomidine with haloperidol and midazolam .
METHODS	Patients in group-2 received haloperidol 5 mg 3 times a day intramuscularly and 0.1 mg/kg intravenously separately and in combination with benzodiazepines ( midazolam , relanium ) .
METHODS	All patients received analgesia with ketoprofen 100 mg each 12 hours and trimeperidin 20 mg intramuscularly .
RESULTS	In 67 % of all patients the symptoms of delirium occurred on the 1st or 2nd day after surgery .
RESULTS	A hyperactive type of delirium dominated ( > 77 % ) .
RESULTS	The average lasting time of delirium was 26.5 hours in group-I and 36.3 hours in group-2 ( p = 0.001 ) .
RESULTS	Spontaneous breathing occurred in 26 patients ( 87 % ) out of group-I and in 18 patients ( 60 % ) out of group-2 ( p = 0.04 ) .
RESULTS	The duration of stay in the ICU was 2.73 days in group-I and 3.5 days in group-2 ( p = 0.04 ) .
RESULTS	Dexmedetomidine provided an average target level of sedation better according to RASS-scale ( p = 0.001 ) .
RESULTS	10 patients ( 33 % ) of group-I and 12 patients ( 40 % ) of group-2 received opioids ( p = 0.8 ) .
RESULTS	Bradycardia as a side effect predominated in group-I ( p = 0.01 ) .
RESULTS	Respiratory depression predominated in group-I ( p = 0.005 ) .
CONCLUSIONS	Dexmedetomidine provides an average target level of sedation , decreases duration of delirium and duration of stay in the ICU .
CONCLUSIONS	Dexmedetomidine does not cause depression of respiration which allows keeping a verbal contact with patients and improving a diagnostics of pain syndrome .
CONCLUSIONS	The most common side effect of the dexmedetomidine use is a dose-depending bradycardia .

###24718019
OBJECTIVE	The aim of the study was to determine the effects of a simulated communication training course on nurses ' communication competence , self-efficacy , communication performance , myocardial infarction knowledge , and general satisfaction with their learning experience .
METHODS	A randomized controlled trial was conducted with a pre-test and two post-tests .
METHODS	The experimental group underwent simulated communication training course and the control group received a case-based communication training course .
RESULTS	The experimental group made more significant improvement in competence and self-efficacy in communication from pre-test to the second post-test than the control group .
RESULTS	Although both groups ' satisfaction with their learning experience significantly increased from the first post-test to the second post-test , the experimental group was found to be more satisfied with their learning experience than the control group .
RESULTS	No significant differences in communication performance and myocardial infarction knowledge between the two groups were identified .
CONCLUSIONS	Scenario-based communication training can be more fully incorporated into in-service education for nurses to boost their competence and self-efficacy in communication and enhance their communication performance in myocardial infarction patient care .
CONCLUSIONS	Introduction of real-life communication scenarios through multimedia in communication education could make learners more motivated to practice communication , hence leading to improved communication capacity .

###24280904
OBJECTIVE	Postoperative breathing exercises are recommended to cardiac surgery patients .
OBJECTIVE	Instructions concerning how long patients should continue exercises after discharge vary , and the significance of treatment needs to be determined .
OBJECTIVE	Our aim was to assess the effects of home-based deep breathing exercises performed with a positive expiratory pressure device for 2 months following cardiac surgery .
METHODS	The study design was a prospective , single-blinded , parallel-group , randomized trial .
METHODS	Patients performing breathing exercises 2 months after cardiac surgery ( n = 159 ) were compared with a control group ( n = 154 ) performing no breathing exercises after discharge .
METHODS	The intervention consisted of 30 slow deep breaths performed with a positive expiratory pressure device ( 10-15 cm H2O ) , 5 times a day , during the first 2 months after surgery .
METHODS	The outcomes were lung function measurements , oxygen saturation , thoracic excursion mobility , subjective perception of breathing and pain , patient-perceived quality of recovery ( 40-Item Quality of Recovery score ) , health-related quality of life ( 36-Item Short Form Health Survey ) , and self-reported respiratory tract infection/pneumonia and antibiotic treatment .
RESULTS	Two months postoperatively , the patients had significantly reduced lung function , with a mean decrease in forced expiratory volume in 1 second to 93 12 % ( P < .001 ) of preoperative values .
RESULTS	Oxygenation had returned to preoperative values , and 5 of 8 aspects in the 36-Item Short Form Health Survey were improved compared with preoperative values ( P < .01 ) .
RESULTS	There were no significant differences between the groups in any of the measured outcomes .
CONCLUSIONS	No significant differences in lung function , subjective perceptions , or quality of life were found between patients performing home-based deep breathing exercises and control patients 2 months after cardiac surgery .

###24419064
BACKGROUND	Maraviroc is unique among approved antiretroviral drugs in targeting the host-cell chemokine coreceptor type-5 receptor .
BACKGROUND	With its novel mechanism of action , we sought to describe the 5-year safety profile of maraviroc .
METHODS	Two large phase 3 studies of maraviroc enrolled HIV-infected treatment-experienced patients and followed them up for 5 or more years .
METHODS	Survival and selected clinical end points were identified and assessed .
RESULTS	A total of 938 enrolled patients received maraviroc-containing regimens .
RESULTS	Rates of death and selected clinical events ( eg , hepatic failure , malignancy , and myocardial infarction ) were low during follow-up .
CONCLUSIONS	Maraviroc was generally safe in treatment-experienced participants for > 5 years .

###25826889
OBJECTIVE	To investigate the feasibility and effectiveness of the modified traction arch of skull ( crossbar traction arch ) for skull traction in treating cervical spine injury by comparing with traditional traction arch of skull .
METHODS	Between June 2009 and June 2013 , 90 patients with cervical vertebrae fractures or dislocation were treated with modified skull traction surgery ( trial group , n = 45 ) and traditional skull traction surgery ( control group , n = 45 ) .
METHODS	There was no significant difference in gender , age , injury types , injury level , the interval between injury and admission , and Frankel grading of spinal injury between 2 groups ( P > 0.05 ) .
METHODS	The clinical efficacy was evaluated after operation by the indexes such as traction arch slippage times , operation time , the infection incidence of the pin hole , incidence of skull perforation , visual analogue scale ( VAS ) , and reduction status of cervical dislocation .
RESULTS	The traction arch slippage times , the infection incidence of the pin hole , operation time , blood loss , and postoperative VAS score in trial group were significantly lower than those in control group ( P < 0.05 ) .
RESULTS	There was no significant difference in the incidence of skull perforation caused by clamp crooks of traction arch between 2 groups ( P = 1.000 ) .
RESULTS	At 2 weeks after operation , the patients had no headaches , infections , or other complications in 2 groups .
RESULTS	In patients with cervical dislocation , 4 of the trial group and 6 of the control group failed to be reset , the reduction rate was 83.33 % ( 20/24 ) and 68.42 % ( 13/19 ) respectively , showing no significant difference ( 2 = 0.618 , P = 0.432 ) .
CONCLUSIONS	The operation with modified traction arch of skull has significant advantages to reduce postoperative complication compared with tradition traction arch of skull .

###25082830
BACKGROUND	Many smokers find currently available nicotine replacement therapies unsatisfactory .
BACKGROUND	The pharmacokinetics of nicotine delivered via a novel inhaler device , and its effect on craving satiation and smoking urges , were compared with the Nicorette Inhalator ( 10 mg ) .
METHODS	Results are reported for Parts B ( N = 24 ) and D ( N = 24 ) of a 4-part Phase I study .
METHODS	Participants ( 18-55 years , 10 cigarettes/day within 1 hr of waking , expired carbon monoxide > 10 ppm on screening ) received single doses of nicotine on consecutive days ( 0.45 and 0.67 mg [ Part B ] and 0.45 mg [ Part D ] via the novel device ; 10 mg via Nicorette [ Parts B and D ] ) .
METHODS	Venous pharmacokinetics , craving , and tolerability were assessed .
RESULTS	In Part B , the novel device 0.45 and 0.67 mg produced significantly lower C max , AUClast , and AUCall than Nicorette ( all p .05 ) , higher AUC0-10 and significantly shorter T max ( 18.7 and 19.2 min vs. 38.0 min , respectively , p .05 ) .
RESULTS	Craving score AUC was lower for the novel device 0.45 mg than for Nicorette in Part B ( 1356.3 vs. 1566.3 , p = .029 ) and approached statistical significance in Part D ( 1208.5 vs. 1402.3 [ p = .059 ] ) .
RESULTS	Mean craving scores were lower for the novel device 0.45 mg than Nicorette at 7/8 postdose timepoints in Part B ( p .05 at 180 and 240 min ) and at all timepoints in Part D ( p .05 at 2 , 4 , and 10 min ) .
CONCLUSIONS	The novel device was at least as effective as the Nicorette Inhalator ( 10mg ) in relieving craving and smoking urges and was statistically superior at certain timepoints and in an overall craving AUC analysis , despite lower total nicotine exposure .

###24602497
OBJECTIVE	To describe and compare the structure and relative severity of symptoms in clinical trial patients diagnosed with Post Traumatic Stress Disorder ( PTSD ) or schizophrenia using the Positive and Negative Syndrome Scale ( PANSS ) , developed originally to evaluate symptoms of schizophrenia .
METHODS	This secondary data analysis used baseline PANSS symptom ratings ( n = 267 ) from a six-month multicenter randomized placebo-controlled trial of adjunctive risperidone in patients with chronic military-related PTSD .
METHODS	First , using a split-half design , Exploratory Factor Analysis ( EFA ) was employed to identify independent factors which were then compared to published factor structures for schizophrenia .
METHODS	Next , Confirmatory Factor Analysis ( CFA ) was applied to the second half of the sample to compare the results of the EFA and published factor structures .
METHODS	Finally , T-tests were used to compare the severity of factor scores between the PTSD sample and the baseline PANSS ratings from the Clinical Antipsychotic Trial for Intervention Effectiveness ( CATIE ) schizophrenia sample ( n = 1460 ) .
RESULTS	EFA suggested five factors similar to those identified in a summary of 29 schizophrenia studies by Wallwork ( Schizophrenia Research , 137:246 -250 ) .
RESULTS	CFA showed that the five factor Wallwork model fit the data better than the EFA , although both had relatively high goodness of fit .
RESULTS	T-tests showed that the PTSD sample had more severe symptoms on the Depressive factor , and the schizophrenia sample on the Positive , Negative , and Disorganized factors , with no significant difference on the Excited factor .
CONCLUSIONS	Veterans with PTSD had similar symptom structure to patients with schizophrenia on the PANSS , but were less symptomatic on psychosis-related factors and more symptomatic on depression .
CONCLUSIONS	Dimensional symptom factors can be virtually the same across diagnoses .

###24481213
OBJECTIVE	In hypertensive persons aged 60 years or below , visit-to-visit SBP variability is directly associated with cardiovascular events , especially stroke .
OBJECTIVE	It is unclear whether such a relationship exists for older persons .
OBJECTIVE	We investigated whether there is a relationship between visit-to-visit SBP variability and cardiovascular events in an elderly population , and identified the factors associated with increased SBP variability .
METHODS	Information from 49771 visits of 5880 patients aged at least 65 years being treated for hypertension in the Second Australian National Blood Pressure study was used .
METHODS	Patients were followed for 4.1 ( median ) years and had eight ( median ) doctor visits during the study .
METHODS	SBP variability was defined as within-individual SD of SBP across study follow-up visits .
RESULTS	Increased visit-to-visit SBP variability was found to be a strong predictor for future cardiovascular events in this elderly population .
RESULTS	The hazard ratio ( 95 % confidence interval ) for any first fatal/nonfatal cardiovascular event for highest decile compared with lowest decile of SBP variability was 2.18 ( 1.52-3 .13 ) after adjusting for sex , age , treatment including other baseline variables , and average on-treatment SBP .
RESULTS	A similar effect was observed for stroke ( hazard ratio 2.78 , 1.28-6 .05 ) , myocardial infarction ( hazard ratio 4.11 , 1.87-9 .06 ) , and heart failure ( hazard ratio 4.79 , 1.82-12 .62 ) .
RESULTS	Highest SBP variability was also a predictor of post-trial fatal cardiovascular events .
RESULTS	Increased visit-to-visit SBP variability was related to age , pulse pressure , changing physicians , smoking , treatment allocation , and the use of multiple BP-lowering drugs .
CONCLUSIONS	These findings suggest that reducing visit-to-visit SBP variability might be an important objective in addition to conventional blood pressure-lowering in elderly hypertensive patients .

###25770814
BACKGROUND	Oral aprepitant , a neurokinin-1 receptor antagonist , is recommended in combination with other anti-emetic agents for the prevention of nausea and vomiting associated with moderately or highly emetogenic chemotherapy in adults , but its efficacy and safety in paediatric patients are unknown .
BACKGROUND	We did this phase 3 trial to examine the safety and efficacy of such treatment in children .
METHODS	In this final analysis of a phase 3 , randomised , multicentre , double-blind study , patients aged 6 months to 17 years with a documented malignancy who were scheduled to receive either moderately or highly emetogenic chemotherapy were randomly assigned with an interactive voice response system to an age-based and weight-based blinded regimen of aprepitant ( 125 mg for ages 12-17 years ; 30 mg/kg up to 125 mg for ages 6 months to < 12 years ) plus ondansetron on day 1 , followed by aprepitant ( 80 mg for ages 12-17 years ; 20 mg/kg up to 80 mg for ages 6 months to < 12 years ) on days 2 and 3 , or placebo plus ondansetron on day 1 followed by placebo on days 2 and 3 ; addition of dexamethasone was allowed .
METHODS	Randomisation was stratified according to patient age , planned use of chemotherapy associated with very high risk of emetogenicity , and planned use of dexamethasone as an anti-emetic .
METHODS	Ondansetron was dosed per the product label for paediatric use or local standard of care .
METHODS	The primary efficacy endpoint was the proportion of patients who achieved complete response ( defined as no vomiting , no retching , and no use of rescue medication ) during the 25-120 h ( delayed phase ) after initiation of emetogenic chemotherapy .
METHODS	Efficacy and safety analyses were done with all randomly assigned patients who received at least one dose of study treatment .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01362530 .
RESULTS	Between Sept 22 , 2011 , and Aug 16 , 2013 , 307 patients were randomly assigned at 49 sites in 24 countries to either the aprepitant group ( 155 patients ) or to the control group ( 152 patients ) .
RESULTS	Three patients in the aprepitant group and two in the control group did not receive study medication , and thus were excluded from analyses .
RESULTS	77 ( 51 % ) of 152 patients in the aprepitant group and 39 ( 26 % ) of 150 in the control group achieved a complete response in the delayed phase ( p < 00001 ) .
RESULTS	The most common grade 3-4 adverse events were febrile neutropenia ( 23 [ 15 % ] of 152 in the aprepitant group vs 21 [ 14 % ] of 150 in the control group ) , anaemia ( 14 [ 9 % ] vs 26 [ 17 % ] ) , and decreased neutrophil count ( 11 [ 7 % ] vs 17 [ 11 % ] ) .
RESULTS	The most common serious adverse event was febrile neutropenia ( 23 [ 15 % ] patients in the aprepitant group vs 22 [ 15 % ] in the control group ) .
CONCLUSIONS	Addition of aprepitant to ondansetron with or without dexamethasone is effective for the prevention of chemotherapy-induced nausea and vomiting in paediatric patients being treated with moderately or highly emetogenic chemotherapy .
BACKGROUND	Merck & Co. , Inc. .

###25219351
OBJECTIVE	To investigate potential drug-drug interactions between topiramate and metformin and pioglitazone at steady state .
METHODS	Two open-label studies were performed in healthy adult men and women .
METHODS	In Study 1 , eligible participants were given metformin alone for 3 days ( 500 mg twice daily [ BID ] ) followed by concomitant metformin and topiramate ( titrated to 100mg BID ) from days 4 to 10 .
METHODS	In Study 2 , eligible participants were randomly assigned to treatment with pioglitazone 30 mg once daily ( QD ) alone for 8 days followed by concomitant pioglitazone and topiramate ( titrated to 96 mg BID ) from days 9 to 22 ( Group 1 ) or to topiramate ( titrated to 96 mg BID ) alone for 11 days followed by concomitant pioglitazone 30 mg QD and topiramate 96 mg BID from days 12 to 22 ( Group 2 ) .
METHODS	An analysis of variance was used to evaluate differences in pharmacokinetics with and without concomitant treatment ; 90 % confidence intervals ( CI ) for the ratio of the geometric least squares mean ( LSM ) estimates for maximum plasma concentration ( Cmax ) , area under concentration-time curve for dosing interval ( AUC12 or AUC24 ) , and oral clearance ( CL/F ) with and without concomitant treatment were used to assess a drug interaction .
RESULTS	A comparison to historical data suggested a modest increase in topiramate oral clearance when given concomitantly with metformin .
RESULTS	Coadministration with topiramate reduced metformin oral clearance at steady state , resulting in a modest increase in systemic metformin exposure .
RESULTS	Geometric LSM ratios and 90 % CI for metformin CL/F and AUC12 were 80 % ( 75 % , 85 % ) and 125 % ( 117 % , 134 % ) , respectively .
RESULTS	Pioglitazone had no effect on topiramate pharmacokinetics at steady state .
RESULTS	Concomitant topiramate resulted in decreased systemic exposure to pioglitazone and its active metabolites , with geometric LSM ratios and 90 % CI for AUC24 of 85.0 % ( 75.7 % , 95.6 % ) for pioglitazone , 40.5 % ( 36.8 % , 44.6 % ) for M-III , and 83.8 % ( 76.1 % , 91.2 % ) for M-IV , respectively .
RESULTS	This effect appeared more pronounced in women than in men .
RESULTS	Coadministration of topiramate with metformin or pioglitazone was generally well tolerated by healthy participants in these studies .
CONCLUSIONS	A modest increase in metformin exposure and decrease in topiramate exposure was observed at steady state following coadministration of metformin 500 mg BID and topiramate 100mg BID .
CONCLUSIONS	The clinical significance of the observed interaction is unclear but is not likely to require a dose adjustment of either agent .
CONCLUSIONS	Pioglitazone 30 mg QD did not affect the pharmacokinetics of topiramate at steady state , while coadministration of topiramate 96 mg BID with pioglitazone decreased steady-state systemic exposure to pioglitazone , M-III , and M-IV .
CONCLUSIONS	While the clinical consequence of this interaction is unknown , careful attention should be given to the routine monitoring for adequate glycemic control of patients receiving this concomitant therapy .
CONCLUSIONS	Concomitant administration of topiramate with metformin or pioglitazone was generally well tolerated and no new safety concerns were observed .

###24855350
BACKGROUND	Pneumonia poses a significant risk in patients with moderate to severe chronic obstructive pulmonary disease but data are limited on the disease phenotypes most susceptible to pneumonia .
METHODS	Cluster analysis using a data-driven recursive partitioning algorithm was employed using baseline data from two pooled one-year randomized exacerbation trials ( n = 3,255 ) of fluticasone furoate/vilanterol or vilanterol alone to identify distinct patient groups at greatest risk of pneumonia or serious ( hospitalization or death ) pneumonia .
RESULTS	Five clusters were identified .
RESULTS	Patients at greater risk of first pneumonia had more severe obstruction ( forced expiratory volume in one second/forced vital capacity < 46 % ) and either a body mass index < 19 kg/m ( 2 ) ( hazard ratio 7.8 , 95 % confidence interval 4.7-13 .0 ; n = 144 ) or a pneumonia history and greater comorbidities ( hazard ratio 4.8 , 95 % confidence interval 3.0-7 .7 ; n = 374 ) relative to the cluster with the lowest pneumonia risk ( reference ; n = 1310 ) .
RESULTS	Multiple comorbidities and use of psychoanaleptics also contributed to an increased risk of pneumonia in more obstructed patients .
RESULTS	Independent of cluster , use of inhaled corticosteroids was associated with pneumonia ( hazard ratio 1.89 , 95 % confidence interval 1.25-2 .84 ) and serious pneumonia ( hazard ratio 2.92 , 95 % confidence interval 1.40-6 .01 ) .
CONCLUSIONS	Cluster analysis can identify patient populations at risk for serious safety outcomes and inform risk management strategies to optimize patient management .
CONCLUSIONS	The greatest risk for pneumonia was in subjects with multiple pneumonia risk factors .

###24264552
OBJECTIVE	In this study , effects of pregabaline on postoperative pain and opioid consumption used perioperatively in patients undergoing modified radical mastectomy ( MRM ) were investigated .
METHODS	Sixty ASA 1-2 patients scheduled for MRM were included .
METHODS	Patients were randomly divided into two and 30 patients were allocated into each group .
METHODS	Group Pregabaline was given pregabaline 150 mg 1 hr before operation and Group Placebo empty capsule .
METHODS	In both groups , anesthesia induction was obtained by penthotal , fentanyl and rocuronium and maintainence by sevoflurane , N2O and O2 .
METHODS	Twelve hr after operation , Group Pregabaline was administered pregabaline 75 mg while Placebo group received empty capsule again .
METHODS	All patients received lornoxicam 8 mg iv 1 hr before end of surgery and ondansetrone 4 mg 30 min before .
METHODS	Patient-controlled analgesia device prepared with morphine was connected to both groups for postoperative analgesia .
METHODS	Postoperative VAS pain scores , hemodynamic parameters , morphine consumption , side-effects like nausea-vomiting , sedation and dizziness were followed and recorded .
RESULTS	Demographic parameters were similar .
RESULTS	VAS scores were significantly lower in Group Pregabaline at 1 , 30 min , 1,4,8 and 12 hr ( p < 0.05 ) .
RESULTS	There was no significant difference in postoperative morphine consumption and need for additional dose , although they were higher in Placebo group .
RESULTS	The patients in Placebo group had higher bothersome scores for side-effects .
RESULTS	Hemodynamic parameters and other side-effects were similar .
CONCLUSIONS	In our study , we showed that pregabalin administered perioperatively increased postoperative analgesic efficacy in MRM operations without making significant side effect , but did not change opioid consumption .
CONCLUSIONS	We think that further studies about this topic must be held with different dose and patient groups .

###25567311
OBJECTIVE	To explore the acute toxic effects and early curative efficacy of concurrent chemotherapy with different doses of cisplatin for Chinese nasopharyngeal carcinoma ( NPC ) patients using intensity-modulated radiation therapy ( IMRT ) .
METHODS	Eighty-eight untreated stage II/III nasopharyngeal cancer patients receiving IMRT and concurrent cisplatin were randomized into two groups receiving different doses of cisplatin .
METHODS	The standard group ( DDP 100 mg/m q3w , n = 44 ) and the study group ( DDP 80 mg/m q3w , n = 44 ) .
METHODS	The acute toxic effects and 3-month therapeutic efficacy ( early curative efficacy ) in patients of the two groups who completed treatment were compared and analyzed .
RESULTS	During the treatment , grade III-IV acute toxic effects were observed in more patients of the standard group compared with that in the study group ( 72.7 % vs. 59.1 % ) , but the difference was statistically not significant ( P = 0.18 ) .
RESULTS	Significant difference was only seen in upper gastrointestinal reaction ( P = 0.01 ) and anemia ( P = 0.03 ) among the non-hematological and hematological adverse events .
RESULTS	No significant differences in other adverse events were found between the two groups ( P < 0.05 ) .
RESULTS	Three months after the completion of radiotherapy , 80 cases of the whole group achieved complete remission ( CR ) in the nasopharynx and neck MRI .
RESULTS	In both the standard group and study group , 40 patients had CR and 4 patients had residual disease , respectively , showing a non-significant difference ( P = 0.51 ) between the two groups .
CONCLUSIONS	During the IMRT course , patients received cisplatin 80 mg/m q3w , experienced less grade III-IV acute toxic effects .
CONCLUSIONS	Concurrent chemoradiotherapy with cisplatin 80 mg/m q3w or 100 mg/m q3w , demonstrate similar early curative efficacy in II/III stage NPC patients in endemic regions of China .

###25376884
BACKGROUND	While physical activity , energy restriction and weight loss are the cornerstone of type 2 diabetes management , less emphasis is placed on optimizing skeletal muscle mass .
BACKGROUND	As muscle is the largest mass of insulin-sensitive tissue and the predominant reservoir for glucose disposal , there is a need to develop safe and effective evidence-based , lifestyle management strategies that optimize muscle mass as well as improve glycaemic control and cardiometabolic risk factors in people with this disease , particularly older adults who experience accelerated muscle loss .
METHODS	Using a two-arm randomized controlled trial , this 6-month study builds upon the community-based progressive resistance training ( PRT ) programme Lift for Life to evaluate whether ingestion of a whey-protein drink combined with vitamin D supplementation can enhance the effects of PRT on glycaemic control , body composition and cardiometabolic health in older adults with type 2 diabetes .
METHODS	Approximately 200 adults aged 50 to 75 years with type 2 diabetes , treated with either diet alone or oral hypoglycaemic agents ( not insulin ) , will be recruited .
METHODS	All participants will be asked to participate in a structured , supervised PRT programme based on the Lift for Life programme structure , and randomly allocated to receive a whey-protein drink ( 20 g daily of whey-protein plus 20 g after each PRT session ) plus vitamin D supplements ( 2000 IU/day ) , or no additional powder and supplements .
METHODS	The primary outcome measures to be collected at baseline , 3 and 6 months will be glycated haemoglobin ( HbA1c ) and insulin sensitivity ( homeostatic model assessment ) .
METHODS	Secondary outcomes will include changes in : muscle mass , size and intramuscular fat ; fat mass ; muscle strength and function ; blood pressure ; levels of lipids , adipokines and inflammatory markers , serum insulin-like growth factor-1 and 25-hydroxyvitamin D ; renal function ; diabetes medication ; health-related quality of life , and cognitive function .
CONCLUSIONS	The findings from this study will provide new evidence on whether increased dietary protein achieved through the ingestion of a whey-protein drink combined with vitamin D supplementation can enhance the effects of PRT on glycaemic control , muscle mass and size , and cardiometabolic risk factors in older adults with type 2 diabetes .
BACKGROUND	Australian New Zealand Clinical Trials ACTRN12613000592741 .

###24380796
OBJECTIVE	To evaluate the effectiveness of the ` Healthy Dads , Healthy Kids ( HDHK ) ' program when delivered by trained facilitators in community settings .
METHODS	A two-arm randomized controlled trial of 93 overweight/obese fathers ( mean [ SD ] age = 40.3 [ 5.3 ] years ; BMI = 32.5 [ 3.8 ] kg/m ( 2 ) ) and their primary school-aged children ( n = 132 ) from the Hunter Region , Australia .
METHODS	In 2010-2011 , families were randomized to either : ( i ) HDHK intervention ( n = 48 fathers , n = 72 children ) or ( ii ) wait-list control group .
METHODS	The 7-week intervention included seven sessions and resources ( booklets , pedometers ) .
METHODS	Assessments were held at baseline and 14-weeks with fathers ' weight ( kg ) as the primary outcome .
METHODS	Secondary outcomes for fathers and children included waist , BMI , blood pressure , resting heart rate , physical activity ( pedometry ) , and self-reported dietary intake and sedentary behaviors .
RESULTS	Linear mixed models ( intention-to-treat ) revealed significant between-group differences for fathers ' weight ( P < .001 , d = 0.24 ) , with HDHK fathers losing more weight ( -3.3 kg ; 95 % CI , -4.3 , -2.4 ) than control fathers ( 0.1 kg ; 95 % CI , -0.9,1.0 ) .
RESULTS	Significant treatment effects ( P < .05 ) were also found for fathers ' waist ( d = 0.41 ) , BMI ( d = 0.26 ) , resting heart rate ( d = 0.59 ) , energy intake ( d = 0.49 ) and physical activity ( d = 0.46 ) and for children 's physical activity ( d = 0.50 ) and adiposity ( d = 0.07 ) .
CONCLUSIONS	HDHK significantly improved health outcomes and behaviors in fathers and children , providing evidence for program effectiveness when delivered in a community setting .

###25603664
BACKGROUND	Pipelle is a silastic curette which does not require a tenaculum or straightening of the cervical fundus axis because of its flexibility and does not require general anaesthesia , whereas Dilatation and curettage ( D&C ) requires hospitalization and general anaesthesia along with the problem of postoperative pain .
BACKGROUND	The objective of the study was to assess the effectiveness of Pipelle sampling in terms of adequate specimen collection and patients ' knowledge and perception about Pipelle and compare it D&C .
METHODS	In this randomized control trial , 203 women presenting with abnormal uterine bleeding were enrolled .
METHODS	The patients were randomly assigned to one of the two procedures .
METHODS	In group A 102 patients were subjected to Pipelle endometrial sampling and in group B 101 patients were enrolled for D&C .
METHODS	Frequencies of adequacy of histopathology reports and cost effectiveness of both groups were compared .
METHODS	Patient 's knowledge , perception , pain and acceptability of the procedure of both groups were also assessed and compared .
RESULTS	The mean age of the patients was 46.3 4.45 years .
RESULTS	Tissue obtained for histopathology was 100 % adequate when the procedure was D&C while it was 98 % in Pipelle group .
RESULTS	In group-A 92 % patients experienced no discomfort , with only 2 % experiencing severe pain and 6 % mild pain .
RESULTS	On the other hand in group-B , 45 % patients experienced moderate and 5 % experienced severe pain up to 9 on visual analogue scale ( VAS ) postoperatively arid requiring post-operative analgesia .
RESULTS	The acceptability for the Pipelle suction curette was 98 % and for the D&C group was 34 % .
RESULTS	Regarding previous knowledge of procedure none of patients ( 100 % ) knew about Pipelle procedure but 98 % patients were aware of D&C procedure .
RESULTS	Pipelle was eight times more cost effective as compared to D&C .
CONCLUSIONS	The results of obtained by endometrial sample by Pipelle and D&C are compareable .
CONCLUSIONS	Pipelle significantly produced less pain than D&C .

###24342419
BACKGROUND	Previous studies have indicated that persons with co-occurring mental health and substance use problems can benefit by attending dual-focus mutual aid groups .
BACKGROUND	However , to date , a trial to test the efficacy of these groups has not been published .
METHODS	This study randomly assigned 203 substance misusing clients attending a mental health or dual-diagnosis facility to either a dual-focus 12-step group ( Double Trouble in Recovery ; DTR ) or a waiting list control group .
METHODS	Participants were followed for 3-6 months .
METHODS	The primary outcome was substance use ( days used in the past 30 with saliva testing to detect under-reporting ) ; secondary outcomes included psychiatric medication adherence , attendance at traditional ( single-focus ) 12-step meetings ( e.g. , AA/NA ) ; and improvement in mental health and substance use problems ( quality of life ) .
METHODS	Multilevel model ( MLM ) regression was used to analyze the nested effect of participants within 8 facilities ( 7 in New York City and 1 in Michigan ) .
METHODS	Regression imputation was used to adjust for drug use under-reporting .
RESULTS	At follow-up 79 % of the subjects were interviewed .
RESULTS	In intent to treat analysis , DTR subjects compared with control subjects used alcohol ( p = .03 ) and any substances ( p = .02 ) on fewer days .
RESULTS	DTR compared with control subjects were also more likely to rate themselves as experiencing better mental health and fewer substance use problems ( p = .001 ) .
RESULTS	There were no effects for DTR on drug use only , medication adherence or NA/AA attendance .
CONCLUSIONS	Findings reported in previous studies on the association between exposure to DTR and reductions in substance use were partially supported in this efficacy trial .

###25539966
BACKGROUND	Intimate partner violence ( IPV ) is associated with HIV infection .
BACKGROUND	We aimed to assess whether provision of a combination of IPV prevention and HIV services would reduce IPV and HIV incidence in individuals enrolled in the Rakai Community Cohort Study ( RCCS ) , Rakai , Uganda .
METHODS	We used pre-existing clusters of communities randomised as part of a previous family planning trial in this cohort .
METHODS	Four intervention group clusters from the previous trial were provided standard of care HIV services plus a community-level mobilisation intervention to change attitudes , social norms , and behaviours related to IPV , and a screening and brief intervention to promote safe HIV disclosure and risk reduction in women seeking HIV counselling and testing services ( the Safe Homes and Respect for Everyone [ SHARE ] Project ) .
METHODS	Seven control group clusters ( including two intervention groups from the original trial ) received only standard of care HIV services .
METHODS	Investigators for the RCCS did a baseline survey between February , 2005 , and June , 2006 , and two follow-up surveys between August , 2006 , and April , 2008 , and June , 2008 , and December , 2009 .
METHODS	Our primary endpoints were self-reported experience and perpetration of past year IPV ( emotional , physical , and sexual ) and laboratory-based diagnosis of HIV incidence in the study population .
METHODS	We used Poisson multivariable regression to estimate adjusted prevalence risk ratios ( aPRR ) of IPV , and adjusted incidence rate ratios ( aIRR ) of HIV acquisition .
METHODS	This study was registered with ClinicalTrials.gov , number NCT02050763 .
RESULTS	Between Feb 15 , 2005 , and June 30 , 2006 , we enrolled 11448 individuals aged 15-49 years .
RESULTS	5337 individuals ( in four intervention clusters ) were allocated into the SHARE plus HIV services group and 6111 individuals ( in seven control clusters ) were allocated into the HIV services only group .
RESULTS	Compared with control groups , individuals in the SHARE intervention groups had fewer self-reports of past-year physical IPV ( 346 [ 16 % ] of 2127 responders in control groups vs 217 [ 12 % ] of 1812 responders in intervention groups ; aPRR 079 , 95 % CI 067-092 ) and sexual IPV ( 261 [ 13 % ] of 2038 vs 167 [ 10 % ] of 1737 ; 080 , 067-097 ) .
RESULTS	Incidence of emotional IPV did not differ ( 409 [ 20 % ] of 2039 vs 311 [ 18 % ] of 1737 ; 091 , 079-104 ) .
RESULTS	SHARE had no effect on male-reported IPV perpetration .
RESULTS	At follow-up 2 ( after about 35 months ) the intervention was associated with a reduction in HIV incidence ( 115 cases per 100 person-years in control vs 087 cases per 100 person-years in intervention group ; aIRR 067 , 95 % CI 046-097 , p = 00362 ) .
CONCLUSIONS	SHARE could reduce some forms of IPV towards women and overall HIV incidence , possibly through a reduction in forced sex and increased disclosure of HIV results .
CONCLUSIONS	Findings from this study should inform future work toward HIV prevention , treatment , and care , and SHARE 's ecological approach could be adopted , at least partly , as a standard of care for other HIV programmes in sub-Saharan Africa .
BACKGROUND	Bill & Melinda Gates Foundation , US National Institutes of Health , WHO , President 's Emergency Plan for AIDS Relief , Fogarty International Center .

###24939642
BACKGROUND	Pediatric rheumatic diseases have a significant impact on children 's quality of life and family functioning .
BACKGROUND	Disease control and management of the symptoms are important to minimize disability and pain .
BACKGROUND	Specialist clinical nurses play a key role in supporting medical teams , recognizing poor disease control and the need for treatment changes , providing a resource to patients on treatment options and access to additional support and advice , and identifying best practices to achieve optimal outcomes for patients and their families .
BACKGROUND	This highlights the importance of investigating follow-up telenursing ( TN ) consultations with experienced , specialist clinical nurses in rheumatology to provide this support to children and their families .
METHODS	This randomized crossover , experimental longitudinal study will compare the effects of standard care against a novel telenursing consultation on children 's and family outcomes .
METHODS	It will examine children below 16 years old , recently diagnosed with inflammatory rheumatic diseases , who attend the pediatric rheumatology outpatient clinic of a tertiary referral hospital in western Switzerland , and one of their parents .
METHODS	The telenursing consultation , at least once a month , by a qualified , experienced , specialist nurse in pediatric rheumatology will consist of providing affective support , health information , and aid to decision-making .
METHODS	Cox 's Interaction Model of Client Health Behavior serves as the theoretical framework for this study .
METHODS	The primary outcome measure is satisfaction and this will be assessed using mixed methods ( quantitative and qualitative data ) .
METHODS	Secondary outcome measures include disease activity , quality of life , adherence to treatment , use of the telenursing service , and cost .
METHODS	We plan to enroll 56 children .
CONCLUSIONS	The telenursing consultation is designed to support parents and children/adolescents during the course of the disease with regular follow-up .
CONCLUSIONS	This project is novel because it is based on a theoretical standardized intervention , yet it allows for individualized care .
CONCLUSIONS	We expect this trial to confirm the importance of support by a clinical specialist nurse in improving outcomes for children and adolescents with inflammatory rheumatisms .
BACKGROUND	ClinicalTrial.gov identifier : NCT01511341 ( December 1st , 2012 ) .

###24293994
BACKGROUND	The use of domiciliary noninvasive positive pressure ventilation ( NPPV ) in stable chronic obstructive pulmonary disease ( COPD ) with chronic hypercapnic respiratory failure has yielded variable effects on survival , quality of life , and dyspnea .
BACKGROUND	We hypothesized that use of NPPV in stable COPD and partial pressure of carbon dioxide ( PaCO2 ) < 52 mmHg might result in improvement in quality of life and dyspnea .
METHODS	Thirty patients with stable COPD ( forced expiratory volume in the first second < 50 % predicted and PaCO2 < 52 mmHg ) were prospectively randomized to receive domiciliary NPPV ( bilevel positive airway pressure , 15/5 cm H2O ) or usual therapy for 6 months .
METHODS	Measurements were made at baseline , 6 weeks , 3 months , and 6 months .
METHODS	Primary outcomes were quality of life as assessed by the Chronic Respiratory Disease Questionnaire ( CRQ ) , and dyspnea as measured by the Transitional Dyspnea Index ( TDI ) .
RESULTS	Fifteen subjects in the NPPV arm and 12 controls completed all the study visits .
RESULTS	At 6 weeks and 3 months , the NPPV arm showed significant improvement in TDI total score .
RESULTS	However , this effect persisted only in the TDI-Task at 6 months ( P = 0.03 ) .
RESULTS	NPPV use was associated with a small improvement in the CRQ-Mastery domain ( 0.6 versus -0.1 , P = 0.04 ) .
RESULTS	The arterial partial pressure of oxygen ( PaO2 ) in the control arm worsened over the period of the study , whereas it remained stable in the NPPV arm ( change -7.2 mmHg versus +2.1 mmHg , respectively , P = 0.02 ) .
CONCLUSIONS	NPPV resulted in a small improvement in quality of life indices in stable COPD patients with PaCO2 < 52 mmHg .
CONCLUSIONS	Future larger studies will clarify the role of NPPV in this stable subgroup of patients with COPD .

###24935075
OBJECTIVE	To evaluate the impact of a senior early assessment model of care on performance measures in a single ED .
METHODS	A pragmatic single-blinded randomised control trial with day of ED presentation randomised to one of three study arms : senior work-up assessment and treatment ( SWAT ) model of care intervention , non-SWAT control or control .
METHODS	The primary outcomes were the proportion of patients meeting National Emergency Access Target ( NEAT ) criteria ( ED length of stay less than 4h ) and ED length of stay .
METHODS	Secondary outcome measured was time to decision to admit in the subgroup of admitted patients .
RESULTS	A total of 1737 patients were analysed .
RESULTS	There was no overall difference in NEAT performance ( 48 % [ 95 % CI 44 , 51 ] vs 41 % ( [ 95 % CI 37 , 45 ] vs 46 % [ 95 % CI 41 , 50 ] , P = 0.09 ) or ED length of stay ( P = 0.65 ) between SWAT , non-SWAT and standard of care control groups , respectively .
RESULTS	In the subgroup of patients discharged from ED ( non-admitted ) , the SWAT intervention group was associated with higher NEAT performance ( P = 0.004 ) compared with non-SWAT and control .
CONCLUSIONS	A senior early assessment model of care was not associated with improved overall NEAT performance and ED length of stay .
CONCLUSIONS	However , there is evidence that improvements were made in the subgroup of discharged patients .
CONCLUSIONS	There was no difference in overall NEAT performance among the three study groups .

###25710761
OBJECTIVE	To determine whether exercise on alternative terrain affects the development of the digital cushion and bony structures of the bovine foot .
METHODS	20 weaned bull calves .
METHODS	Two-month-old calves were randomly allocated to an exercise or control group .
METHODS	For 4 months , the control group was maintained in grass paddocks , and the exercise group was maintained in a 0.8-km lane with a mixed terrain of dirt , stones ( 0.32 - to 0.95-cm pea gravel and 5-cm crusher run ) , and grass .
METHODS	Water and food for the exercise group were located at opposite ends of the lane ; calves were fed twice daily , which ensured they walked 3.2 km/d .
METHODS	Pedometers were applied to all calves to measure distance traveled .
METHODS	All calves were slaughtered at 6 months of age .
METHODS	The right forefeet and hind feet were harvested for MRI and CT evaluation .
RESULTS	Control calves walked a mean of 1.1 km daily , whereas the exercised calves walked a mean of 3.2 km daily .
RESULTS	Mean digital cushion volume and surface area were 25,335 mm ( 3 ) and 15,647 mm ( 2 ) , respectively , for the exercised calves and 17,026 mm ( 3 ) and 12,745 mm ( 2 ) , respectively , for the control calves .
RESULTS	When weight was controlled , mean digital cushion volume and surface area for the exercise group were increased by 37.10 % and 18.25 % , respectively , from those for the control group .
CONCLUSIONS	Results indicated that exercise on alternative terrain increased the volume and surface area of the digital cushion of the feet of dairy calves , which should make them less susceptible to lameness .

###25038977
OBJECTIVE	A secondary objective of this head-to-head study of lisdexamfetamine dimesylate ( LDX ) and atomoxetine ( ATX ) was to assess treatment response rates in children and adolescents with attention-deficit hyperactivity disorder ( ADHD ) and an inadequate response to methylphenidate ( MPH ) .
OBJECTIVE	The primary efficacy and safety outcomes of the study , SPD489-317 ( ClinicalTrials.gov NCT01106430 ) , have been published previously .
METHODS	In this 9-week , double-blind , active-controlled study , patients aged 6-17 years with a previous inadequate response to MPH were randomized ( 1:1 ) to dose-optimized LDX ( 30 , 50 or 70 mg/day ) or ATX ( patients < 70 kg : 0.5-1 .2 mg/kg/day , not to exceed 1.4 mg/kg/day ; patients 70 kg : 40 , 80 or 100 mg/day ) .
METHODS	Treatment response was a secondary efficacy outcome and was predefined as a reduction from baseline in ADHD Rating Scale IV ( ADHD-RS-IV ) total score of at least 25 , 30 or 50 % .
METHODS	Sustained response was predefined as a reduction from baseline in ADHD-RS-IV total score ( 25 , 30 or 50 % ) or a Clinical Global Impressions ( CGI ) - Improvement ( CGI-I ) score of 1 or 2 throughout weeks 4-9 .
METHODS	CGI-Severity ( CGI-S ) scores were also assessed , as an indicator of remission .
RESULTS	A total of 267 patients were enrolled ( LDX , n = 133 ; ATX , n = 134 ) and 200 completed the study ( LDX , n = 99 ; ATX , n = 101 ) .
RESULTS	By week 9 , significantly ( p < 0.01 ) greater proportions of patients receiving LDX than ATX met the response criteria of a reduction from baseline in ADHD-RS-IV total score of at least 25 % ( 90.5 vs. 76.7 % ) , 30 % ( 88.1 vs. 73.7 % ) or 50 % ( 73.0 vs. 50.4 % ) .
RESULTS	Sustained response rates were also significantly ( p < 0.05 ) higher among LDX-treated patients ( ADHD-RS-IV 25 , 66.1 % ; ADHD-RS-IV 30 , 61.4 % ; ADHD-RS-IV 50 , 41.7 % ; CGI-I , 52.0 % ) than among ATX-treated individuals ( ADHD-RS-IV 25 , 51.1 % ; ADHD-RS-IV 30 , 47.4 % ; ADHD-RS-IV 50 , 23.7 % ; CGI-I , 39.3 % ) .
RESULTS	Finally , by week 9 , 60.7 % of patients receiving LDX and 46.3 % of those receiving ATX had a CGI-S score of 1 ( normal , not at all ill ) or 2 ( borderline mentally ill ) , and greater proportions of patients in the LDX group than the ATX group experienced a reduction from baseline of at least one CGI-S category .
CONCLUSIONS	Both LDX and ATX treatment were associated with high levels of treatment response in children and adolescents with ADHD and a previous inadequate response to MPH .
CONCLUSIONS	However , within the parameters of the study , LDX was associated with significantly higher treatment response rates than ATX across all response criteria examined .
CONCLUSIONS	In addition , higher proportions of patients in the LDX group than the ATX group had a CGI-S score of 1 or 2 by week 9 , indicating remission of symptoms .
CONCLUSIONS	Both treatments were generally well tolerated , with safety profiles consistent with those observed in previous studies .

###25906561
OBJECTIVE	To compare the efficacy differences in the treatment of somatoform pain disorder between resuscitation and tranquilization acupuncture technique and oral administration of deanxit .
METHODS	Forty cases of somatoform pain disorder ( complicated with mild and moderate depression ) were randomized into an acupuncture group and a western medication group , 20 cases in each one .
METHODS	In the acupuncture group .
METHODS	acupuncture was applied to Shenting ( GV 24 ) .
METHODS	Shuigou ( V 26 ) .
METHODS	Sishencong ( EX HN I ) to Baihui ( ( V 20 ) ( penetrating technique ) .
METHODS	Feng-chi ( GB 20 ) .
METHODS	etc. .
METHODS	The treatment was given once every day .
METHODS	6 times a week .
METHODS	In the western medication group .
METHODS	the anti depression drug .
METHODS	deanxit was prescribed for oral administration , 1 tablet in every morning and lunchtime each day .
METHODS	In 8 weeks of continuous treatment , the visual analogue scale ( VAS ) and Hamilton depression scale 17 items ( HAMD ) were used to evaluate the efficacy in the patients of the two groups , the adverse reactions were observed and the recurrence rate was followed up in 3 months .
RESULTS	After treatment .
RESULTS	VAS and HIIAMD scores were all apparently reduced as compared with those before treatment in the patients of the two groups ( all P < 0.05 ) .
RESULTS	The reducing amplitude of VAS score in the acupuncture group was greater than that in the western medication group ( P < 0.05 ) and that of HAM ) score was not different significantly as compared with that in the western mnedica tion group ( P > 0.05 ) .
RESULTS	There was no adverse reaction in the acupuncture group and were 3 cases as dizziness , trembling .
RESULTS	dry mouth and constipation in the western medication group .
RESULTS	The curative and remarkably effective rate was 50.0 ( 10 ( 20 ) ) in the acupuncture group , better than 15.0 % ( 3/20 ) in the western medication group ( P < 0.05 ) .
RESULTS	The recurrence rate was 10.0 ( 2/20 ) in the acupuncture group .
RESULTS	lower than 35.0 % ( 7/20 ) in the western medication group ( P < 0.05 ) .
CONCLUSIONS	The resuscitation and tranquilization acupuncture technique achieves the definite efficacy on somatoform pain disorder , relieves depression symptoms of patients , especially pain and reduces adverse reactions and recurrence rate .
CONCLUSIONS	The effects of this therapy are advanced as compared with deanxit .

###24456059
OBJECTIVE	The purpose of this study was to investigate the effect of mild-to - moderate ( m-mod ) traumatic brain injury ( TBI ) on spontaneous object ( SO ) recognition and temporal order ( TO ) memory in male Wistar rats and to compare the effects of environmental enrichment ( EE ) and simvastatin ( Sim ) on SO and TO memory post-injury .
METHODS	A randomized repeated measure experimental design was used .
METHODS	Seven days after arrival , animals received the injury or sham surgery .
METHODS	Using a Y-shaped maze , SO and TO memory was assessed in the two groups of animals at 6 , 24 , 48 , 72 hours and 7 , 14 , 21 and 35 days post-surgery .
METHODS	Total time exploring each object and discrimination ratio were calculated and analysed .
METHODS	Then SO and TO memory were compared between two groups that received either Sim or EE for 2 hours daily starting 24 hours post-injury and a sham group that received saline for 14 days post-injury .
RESULTS	The results showed that the injury impaired SO and TO memory compared to the sham up to 35 days post-trauma .
RESULTS	Injured animals exhibited familiarity preference , novelty aversion and impaired TO performance .
RESULTS	EE improved the animals ' SO recognition deficits 7 days post-injury after a shorter delay ( 1 minute ) only and Sim reversed TO memory deficits 14 days post-injury after a longer delay ( 60 minutes ) .
CONCLUSIONS	Persistent SO and TO memory deficits follow TBI in animals ; Simv and EE seem to be promising therapies of TBI memory deficits .

###25395078
OBJECTIVE	Currently , most ESRD patients are treated with open surgical technique or with laparoscopic technique .
OBJECTIVE	In this study , we examined the role of the ureteroscope-assisted `` Mini-Perc '' technique versus the modified open surgery in the treatment of ESRD in a prospective randomized manner .
METHODS	A total of 72 patients with chronic renal failure were prospectively randomized for the ureteroscope-assisted `` Mini-Perc '' technique or modified open surgery .
METHODS	Intraoperative and postoperative morbidity , incision size , dose of local anesthesia , operative time , hospital stay , and initial catheter survival and follow-up were compared for both methods .
RESULTS	`` Mini-Perc '' group was associated with shorter incision size , operative time , and hospital stay , with lower dose of local anesthesia and incidence of bloody ascites .
RESULTS	Two of five patients with the history of abdominal surgery in `` Mini-Perc '' group required adhesiolysis under direct vision of telescope .
RESULTS	All adhesions were easily dissected .
RESULTS	All complications of leakage ( 8.1 % ) and incisional hernia ( 2.7 % ) occurred in the open surgery group , but a difference of no significant value with `` Mini-Perc '' group ( p = 0.2400 , p = 1.0000 ) .
RESULTS	There was no any other significant difference in common complications between two groups .
RESULTS	After 2 years of follow-up , 54 patients ( 75 % ) survived with their initial PD catheter .
RESULTS	The overall death was 5 ( 6.9 % ) .
CONCLUSIONS	Compared to modified open surgical technique , the ureteroscope-assisted `` Mini-Perc '' technique can be used to achieve the same clinical efficacy for placement of peritoneal dialysis catheters in ESRD patients , and it carries minimal morbidity .

###25104916
BACKGROUND	Craniotomy patients have a high incidence of postoperative nausea and vomiting ( PONV ) .
BACKGROUND	This prospective , randomized , double-blind , multi-center study was performed to evaluate the efficacy of prophylactic ramosetron in preventing PONV compared with ondansetron after elective craniotomy in adult patients .
METHODS	A total of 160 American Society of Anesthesiologists physical status I-II patients aged 19-65 years who were scheduled to undergo elective craniotomy for various intracranial lesions were enrolled in this study .
METHODS	All patients received total intravenous anesthesia ( TIVA ) with propofol and remifentanil .
METHODS	Patients were randomly allocated into three groups to receive ondansetron ( 4mg ; group A , n = 55 ) , ondansetron ( 8mg ; group B , n = 54 ) , or ramosetron ( 0.3 mg ; group C , n = 51 ) intravenously at the time of dural closure .
METHODS	The incidence of PONV , the need for rescue antiemetics , pain score , patient-controlled analgesia ( PCA ) consumption , and adverse events were recorded 48h postoperatively .
RESULTS	Among the initial 160 patients , 127 completed the study and were included in the final analysis .
RESULTS	The incidences of PONV were lower ( nausea , 14 % vs. 59 % and 41 % , respectively ; P < 0.001 ; vomiting , P = 0.048 ) and the incidence of complete response was higher ( 83 % vs. 37 % and 59 % , respectively ; P < 0.001 ) in group C than in groups A and B at 48h postoperatively .
RESULTS	There were no significant differences in the incidence of PONV or need for rescue antiemetics 0-2h postoperatively , but significant differences were observed in the incidence of PONV and complete response among the three groups 2-48h postoperatively .
RESULTS	No statistically significant intergroup differences were observed in postoperative pain , PCA consumption , or adverse events .
CONCLUSIONS	Intravenous administration of ramosetron at 0.3 mg reduced the incidence of PONV and rescue antiemetic requirement in craniotomy patients .
CONCLUSIONS	Ramosetron at 0.3 mg was more effective than ondansetron at 4 or 8mg for preventing PONV in adult craniotomy patients .
BACKGROUND	CLINICAL RESEARCH INFORMATION SERVICE ( CRIS ) IDENTIFIER : KCT0000320 .
BACKGROUND	Registered 9 January 2012 .

###25475247
BACKGROUND	Many patients with stroke receive integrative medicine in China , which includes the basic treatment of Western medicine and routine rehabilitation , in conjunction with acupuncture and Chinese medicine .
BACKGROUND	The question of whether integrative medicine is efficacious for stroke rehabilitation is still controversial and very little research currently exists on the integrated approach for this condition .
BACKGROUND	Consequently , we will conduct a multicentre , randomised , controlled , assessor-blinded clinical trial to assess the effectiveness of integrative medicine on stroke rehabilitation .
METHODS	360 participants recruited from three large Chinese medical hospitals in Zhejiang Province will be randomly divided into the integrative medicine rehabilitation ( IMR ) group and the conventional rehabilitation ( CR ) group in a 1:1 ratio .
METHODS	Participants in the IMR group will receive acupuncture and Chinese herbs in addition to basic Western medicine and rehabilitation treatment .
METHODS	The CR group will not receive acupuncture and Chinese herbal medicine .
METHODS	The assessment data will be collected at baseline , 4 and 8 weeks postrandomisation , and then at 12 weeks ' follow-up .
METHODS	The primary outcome is measured by the Modified Barthel Index .
METHODS	The secondary outcomes are the National Institutes of Health Stroke Scale ( NIHSS ) , Fugl-Meyer Assessment , the mini-mental state examination and Montreal Cognitive , Hamilton 's Depression Scale and Self-Rating Depression Scale , and the incidence of adverse events .
BACKGROUND	Ethical approval was obtained from ethics committees of three hospitals .
BACKGROUND	The results will be disseminated in a peer-reviewed journal and presented at international congresses .
BACKGROUND	The results will also be disseminated to patients by telephone , during follow-up calls inquiring on patient 's post-study health status .
BACKGROUND	Chinese Clinical Trial Register : ChiCTR-TRC-12001972 , http://www.chictr.org/en/proj/show.aspx?proj=2561 .

###24637587
OBJECTIVE	In contrast to conventional breast imaging techniques , one major diagnostic benefit of breast magnetic resonance imaging ( MRI ) is the simultaneous acquisition of morphologic and dynamic enhancement characteristics , which are based on angiogenesis and therefore provide insights into tumor pathophysiology .
OBJECTIVE	The aim of this investigation was to intraindividually compare 2 macrocyclic MRI contrast agents , with low risk for nephrogenic systemic fibrosis , in the morphologic and dynamic characterization of histologically verified mass breast lesions , analyzed by blinded human evaluation and a fully automatic computer-assisted diagnosis ( CAD ) technique .
METHODS	Institutional review board approval and patient informed consent were obtained .
METHODS	In this prospective , single-center study , 45 women with 51 histopathologically verified ( 41 malignant , 10 benign ) mass lesions underwent 2 identical examinations at 1.5 T ( mean time interval , 2.1 days ) with 0.1-mmol kg doses of gadoteric acid and gadobutrol .
METHODS	All magnetic resonance images were visually evaluated by 2 experienced , blinded breast radiologists in consensus and by an automatic CAD system , whereas the morphologic and dynamic characterization as well as the final human classification of lesions were performed based on the categories of the Breast imaging reporting and data system MRI atlas .
METHODS	Lesions were also classified by defining their probability of malignancy ( morpho-dynamic index ; 0 % -100 % ) by the CAD system .
METHODS	Imaging results were correlated with histopathology as gold standard .
RESULTS	The CAD system coded 49 of 51 lesions with gadoteric acid and gadobutrol ( detection rate , 96.1 % ) ; initial signal increase was significantly higher for gadobutrol than for gadoteric acid for all and the malignant coded lesions ( P < 0.05 ) .
RESULTS	Gadoteric acid resulted in more postinitial washout curves and fewer continuous increases of all and the malignant lesions compared with gadobutrol ( CAD hot spot regions , P < 0.05 ) .
RESULTS	Morphologically , the margins of the malignancies were different between the 2 agents , whereas gadobutrol demonstrated more spiculated and fewer smooth margins ( P < 0.05 ) .
RESULTS	Lesion classifications by the human observers and by the morpho-dynamic index compared with the histopathologic results did not significantly differ between gadoteric acid and gadobutrol .
CONCLUSIONS	Macrocyclic contrast media can be reliably used for breast dynamic contrast-enhanced MRI .
CONCLUSIONS	However , gadoteric acid and gadobutrol differed in some dynamic and morphologic characterization of histologically verified breast lesions in an intraindividual , comparison .
CONCLUSIONS	Besides the standardization of technical parameters and imaging evaluation of breast MRI , the standardization of the applied contrast medium seems to be important to receive best comparable MRI interpretation .

###24723582
BACKGROUND	Left ventricular hypertrophy ( LVH ; high LV mass [ LVM ] ) is traditionally classified as concentric or eccentric based on LV relative wall thickness .
BACKGROUND	We evaluated the prediction of subsequent adverse events in a new 4-group LVH classification based on LV dilatation ( high LV end-diastolic volume [ EDV ] index ) and concentricity ( mass/end-diastolic volume [ M/EDV ] ( 2/3 ) ) in hypertensive patients .
RESULTS	In the Losartan Intervention for Endpoint Reduction ( LIFE ) echocardiography substudy , 939 hypertensive patients with measurable LVM at baseline were randomized to a mean of 4.8 years of losartan - or atenolol-based treatment .
RESULTS	Patients with LVH ( LVM/body surface area 116 and 96 g/m ( 2 ) in men and woman , respectively ) were divided into 4 groups-concentric nondilated ( increased M/EDV , normal EDV ) , eccentric dilated ( increased EDV , normal M/EDV ) , concentric dilated ( increased M/EDV and EDV ) , and eccentric nondilated ( normal M/EDV and EDV ) - and compared with patients with normal LVM .
RESULTS	Time-varying LVH classes were tested for association with all-cause and cardiovascular mortality and a composite end point of myocardial infarction , stroke , heart failure , and cardiovascular death in multivariable Cox analyses .
RESULTS	At baseline , the LVs were categorized as eccentric nondilated in 12 % , eccentric dilated in 20 % , concentric nondilated in 29 % , concentric dilated in 14 % , and normal LVM in 25 % .
RESULTS	Treatment changed the prevalence of 4 LVH groups to 23 % , 4 % , 5 % , and 7 % ; 62 % had normal LVM after 4 years .
RESULTS	In time-varying Cox analyses , compared with normal LVM , those with eccentric dilated and both concentric nondilated and dilated LVH had increased risks of all-cause or cardiovascular mortality or the composite end point , whereas the eccentric nondilated group did not .
CONCLUSIONS	Hypertensive patients with relatively mild LVH without either increased LV volume or concentricity have similar risk of all-cause mortality or cardiovascular events because hypertensive patients with normal LVM seem to be a low-risk group .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00338260 .

###25951308
OBJECTIVE	The purpose of this study was to evaluate the clinical success of three fissure sealants ( FSs ) with different contents on primary teeth .
METHODS	Three FSs were used to seal 150 primary molars in 75 children aged 4-7 years .
METHODS	All FSs were placed on occlusal surfaces in a split-mouth and randomized clinical trial .
METHODS	For patients in Group1 , amorphous calcium phosphate ( ACP ) containing resin-based sealant ( RBS ) ( Aegis ) was applied to a primary molar tooth on one side , and non-fluoride RBS ( Helioseal ) FS was applied to symmetrical molar tooth .
METHODS	For patients in Group2 , fluoride-containing RBS ( Helioseal F ) was applied to a primary molar tooth on one side , and Helioseal FS was applied to symmetrical molar tooth .
METHODS	For patients in Group3 , Helioseal FS was applied to a primary molar tooth on one side , and Aegis FS was applied to symmetrical molar tooth .
METHODS	Clinical evaluation of FSs was carried out to assess retention , marginal discoloration , marginal adaptation , and the presence of caries in months 1,3,6,12,18 and 24 after FS application .
RESULTS	There were no significant differences for all criteria in groups 2 and 3 ( p0 .05 ) .
RESULTS	In group 1 , cumulative success rates according to 24 months ' follow-up were statistically insignificant during the comparisons performed in terms of retention , marginal adaptation , and presence of caries ( p0 .05 ) .
RESULTS	Marginal discoloration was found to be statistically significant ( p < 0.05 ) .
CONCLUSIONS	RBS containing ACP or fluoride may be more effective than conventional RBS for caries prevention .

###25112087
OBJECTIVE	To observe the efficacy on primary osteoporosis treated with spreading moxibustion for warming yang and activating blood circulation so as to provide the effective clinical therapeutic methods for osteoporosis .
METHODS	Sixty cases of primary osteoporosis were randomized into a spreading moxibustion group ( 30 cases ) and a calcium tablet group ( 30 cases ) .
METHODS	In the calcium tablet group , caltrate was prescribed for oral administration , 600 mg per day .
METHODS	In the spreading moxibustion group , on the basis of the treatment as the calcium tablet group , the spreading moxibustion was applied at Dazhui ( GV 14 ) to Yaoshu ( GV 2 ) for warming yang and activating blood circulation .
METHODS	The duration of treatment was 12 weeks .
METHODS	Visual analogue scale ( VAS ) score , TCM clinical symptom score and bone mineral density ( BMD ) were observed and compared before and after treatment in the patients between the two groups .
RESULTS	VAS scores were reduced apparently after treatment in the two groups ( both P < 0.01 ) and the results in the spreading moxibustion group were obviously superior to that in the calcium tablet group ( 2.36 + / - 0.43 vs 4.52 + / - 0.35 , P < 0.01 ) .
RESULTS	BMD were all increased in the two groups ( P < 0.05 , P < 0.01 ) and the results in the spreading moxibustion group were superior to those in the calcium tablet group ( both P < 0.05 ) .
RESULTS	The total clinical effective rate was 86.67 % ( 26/30 ) in the spreading moxibustion group , apparently better than 63.33 % ( 19/30 ) in the calcium tablet group ( P < 0.05 ) .
RESULTS	TCM clinical symptom scores after treatment were all reduced apparently in the two groups ( both P < 0.01 ) , and the result in the spreading moxibustion group was obviously superior to that in the calcium tablet group ( 4.72 + / - 1.90 vs 6.82 + / - 2.30 , P < 0.01 ) .
RESULTS	The total effective rate of TCM symptoms was 93.33 % ( 28/30 ) in the spreading moxibustion group , apparently better than 70.00 % ( 21/30 ) in the calcium tablet group ( P < 0.05 ) .
CONCLUSIONS	The combined therapy of spreading moxibustion for warming yang and activating blood circulation and the oral administration of caltrate apparently relieves pain and TCM clinical symptoms , improves BMD in the patients of osteoporosis and achieves definite clinical efficacy in the patients of osteoporosis .

###25488309
OBJECTIVE	In oral and maxillofacial outpatient surgery , sedation techniques are an important component in patient management for a wide variety of surgical procedures .
OBJECTIVE	Fentanyl and midazolam are commonly used sedatives with different mechanisms of action and specific analgesic or amnestic properties .
OBJECTIVE	This study examined whether the order of their administration would affect a patient 's pain perception or procedural vital signs .
METHODS	After institutional review board approval and written informed consent , a prospective , randomized , parallel-group clinical trial was conducted in patients who planned to undergo removal of at least 2 third molars under intravenous moderate sedation .
METHODS	Patients were randomly assigned to 1 of 2 groups .
METHODS	The fentanyl-first group received fentanyl and then midazolam ; the midazolam-first group received midazolam and then fentanyl .
METHODS	Recollection of the intraoperative pain score was assessed 24 hours after surgery using the Wong-Baker FACES pain scale .
METHODS	The Mann-Whitney U test was used to assess for the presence of a statistically significant difference between the 2 groups .
METHODS	Statistically significant differences in procedural vital sign fluctuations were examined using the t test .
METHODS	Patients ' satisfaction with the procedure was assessed and intergroup comparisons were made .
RESULTS	Sixty-six patients were enrolled , 1 of whom did not complete the study .
RESULTS	Recollected procedural pain scores at 24 hours after surgery were not statistically different between groups .
RESULTS	Median scores on the Wong-Baker FACES pain scale for the 2 groups were 2.0 ( interquartile range , 3.1 ) for the fentanyl-first group and 1.5 ( interquartile range , 2.5 ) for the midazolam-first group ( P = .333 ) .
RESULTS	There was no statistical difference in the change in vital signs from baseline to 2 surgical end points in the 2 groups .
RESULTS	In addition , patient satisfaction with the procedure did not statistically differ between the 2 groups .
CONCLUSIONS	In this study , selective sequencing of midazolam or fentanyl during an intravenous moderate-sedation procedure did not result in a measurable difference of recollected procedural pain scores at 24 hours after third molar extraction .
CONCLUSIONS	The choice of the sedation agents and the order of their administration should be tailored to the patient 's needs , type of surgical procedure , and surgeon preference .

###25509258
OBJECTIVE	To explore the effect of compound qizhu granule ( CQG ) on cellular immunity of chronic hepatitis B ( CHB ) patients .
METHODS	Totally 103 CHB patients treated with lamivudin ( LAM ) for 6 months , who had partial virological response ( HBeAg positive ) were randomly assigned to two groups , 50 in the treatment group and 53 in the control group .
METHODS	All patients took LAM 100 mg ( once a day ) plus ADV 10 mg ( once a day ) .
METHODS	Patients in the treatment group additionally took CQG , one dose per day .
METHODS	After one-year treatment hepatitis B virus ( HBV ) DNA negative rates , HBeAg seroconversion , levels of HBV specific cytotoxic T lymphocyte ( CTL ) , non-specific CTL and natural killing ( NK ) cells were compared between the two groups .
RESULTS	After 1-year treatment , HBV DNA negative rate of the treatment group was 88 : 0 % in 44 cases , slightly higher than that of the control group ( 41 cases , 77.4 % ) , but with no statistical difference ( P > 0.05 ) .
RESULTS	HBeAg seroconversion of the treatment group was 32.0 % in 16 cases , higher than that of the control group ( 8 cases , 15.1 % ) , with statistical difference ( P < 0.05 ) .
RESULTS	Levels of HBV specific CTL ( 0.79 % 0.07 % ) , non-specific CTL ( 19.4 % 1.8 % ) and NK cells ( 14.1 % 1.5 % ) of the treatment group were higher than those of the control group ( 0.58 % 0.08 % , 17.5 % 1.7 % , and 11.1 % 1.5 % , respectively ; allP < 0.01 ) .
CONCLUSIONS	Treating CHB patients with partial virological response by ADV plus CQG could improve specific and non-specific cellular immunity , thereby elevating HBeAg seroconversion rate .

###24576803
OBJECTIVE	Stroke is often associated with cognitive decline which can be evaluated by event-related potentials ( ERP ) .
OBJECTIVE	So far , only little is known about the impact of stroke on ERP .
OBJECTIVE	The aim of this prospective study was to follow-up ERP latencies in stroke patients and to evaluate the influence of sex , vascular territory of stroke , reinfarction , and secondary prevention ( acetylsalicylic acid versus piracetam ) .
METHODS	Visually evoked ERP were recorded in 563 stroke patients at baseline ( i.e. , within four weeks after stroke ) , after 12 months , and after 24 months .
METHODS	The latencies of the P2 , N2 , and P3 components were assessed and compared between different subgroups .
RESULTS	The P3 latency is initially more increased in female stroke patients , but shows a better recovery in women compared to men .
RESULTS	A secondary prevention with piracetam leads to a significantly better recovery of ERP latencies than a treatment with acetylsalicylic acid .
RESULTS	Data suggests a better recovery of left hemispheric infarction compared to right hemispheric infarction .
RESULTS	Patients , who suffered another stroke during the follow-up period , showed a prolongation of P3 latency , suggesting an increased P3 latency to be associated with reinfarction .
CONCLUSIONS	Our results suggest that ERP measurement is an appropriate method for diagnosis and follow-up of cognitive changes after ischemic stroke .
CONCLUSIONS	In particular the P3 component is an indicator for patients at risk for reinfarction .

###24464791
OBJECTIVE	The reduction in acquired infections ( AI ) due to methicillin-resistant Staphylococcus aureus ( MRSA ) with the mupirocin/chlorhexidine ( M/C ) decontamination regimen has not been well studied in intubated patients .
OBJECTIVE	We performed post hoc analysis of a prior trial to assess the impact of M/C on MRSA AI and colonization .
METHODS	We conducted a multicenter , placebo-controlled , randomized , double-blind study with the primary aim to reduce all-cause AI .
METHODS	The two regimens used [ topical polymyxin and tobramycin ( P/T ) , nasal mupirocin with chlorhexidine body wash ( M/C ) , or corresponding placebos for each regimen ] were administered according to a 2 2 factorial design .
METHODS	Participants were intubated patients in the intensive care units of three French university hospitals .
METHODS	The patients enrolled in the study ( n = 515 ) received either active P/T ( n = 130 ) , active M/C ( n = 130 ) , both active regimens ( n = 129 ) , or placebos only ( n = 126 ) for the period of intubation and an additional 24 h.
METHODS	The incidence and incidence rates ( per 1,000 study days ) of MRSA AI were assessed .
METHODS	Due to the absence of a statistically significant interaction between the two regimens , analysis was performed at the margins by comparing all patient receiving M/C ( n = 259 ) to all patients not receiving M/C ( n = 256 ) , and all patients receiving P/T ( n = 259 ) to all patients not receiving P/T ( n = 256 ) .
RESULTS	Incidence [ odds ratio ( OR ) 0.39 , 95 % confidence interval ( CI ) ( 0.16-0 .96 ) , P = 0.04 ] and incidence rates [ incidence rate ratio ( IRR ) 0.41 , 95 % CI 0.17-0 .97 , P = 0.05 ] of MRSA AI were significantly lower with the use of M/C .
RESULTS	We also observed an increase in the incidence ( OR 2.50 , 95 % CI 1.01-6 .15 , P = 0.05 ) and the incidence rate ( IRR 2.90 , 95 % CI 1.20-8 .03 , P = 0.03 ) of MRSA AI with the use of P/T .
CONCLUSIONS	Among our study cohort of intubated patients , the use of M/C significantly reduced MRSA AI .

###24622716
BACKGROUND	In patients with type 2 diabetes , improving adherence to medication is important in order to maintain favourable glycaemic control during long-term treatment and , thus , prevent the onset or aggravation of complications .
BACKGROUND	SYR-472 is a novel once-weekly oral DPP-4 inhibitor for type 2 diabetes , which could be a treatment option when clinicians seek to improve medication adherence by reducing the number of required administrations .
BACKGROUND	In this study , we assessed the efficacy and safety of SYR-472 in patients with type 2 diabetes .
METHODS	In this phase 2 , multicentre , randomised , double-blind , parallel-group , placebo-controlled , dose-ranging study , we included Japanese patients with inadequately controlled type 2 diabetes despite diet and exercise treatment .
METHODS	Patients were randomly assigned ( allocation ratio 1:1:1:1:1:1 ) to receive either placebo or SYR-472 at five different doses ( 125 mg , 25 mg , 50 mg , 100 mg , or 200 mg ) .
METHODS	Randomisation was done with a permuted block schedule .
METHODS	All investigators and patients were unaware of the treatment assignment .
METHODS	Treatment drug was given orally once weekly for 12 weeks .
METHODS	The primary efficacy variable was the change in HbA1c concentration from baseline to the end of treatment .
METHODS	This study has been registered at the Japan Pharmaceutical Information Center ( JAPIC ) Clinical Trials Information : Japic CTI-090899 .
RESULTS	322 patients were randomly assigned to receive placebo ( 55 patients ) or SYR-472 at 125 mg ( 54 patients ) , 25 mg ( 52 patients ) , 50 mg ( 51 patients ) , 100 mg ( 55 patients ) or 200 mg ( 55 patients ) .
RESULTS	The least square ( LS ) mean change in HbA1c concentration from baseline was 035 % ( SE 0068 ; -20 mmol/mol ) for the placebo group , -037 % ( 0068 ; -28 mmol/mol ) for the 125 mg group , -032 % ( 0070 ; -27 mmol/mol ) for the 25 mg group , -042 % ( 0070 ; -28 mmol/mol ) for the 50 mg group , -054 % ( 0068 ; -29 mmol/mol ) for the 100 mg group , and -055 % ( 0069 ; -30 mmol/mol ) for the 200 mg group .
RESULTS	In general , HbA1c concentration decreased in a dose-dependent manner ( trend test using contrast coefficients p < 00001 ) and the reduction was significantly greater for all SYR-472 doses ( p < 00001 for each group ) than for placebo .
RESULTS	The incidence of treatment-emergent adverse events in each SYR-472 group was similar to that in the placebo group .
RESULTS	The most common adverse event was nasopharyngitis in all groups .
RESULTS	No episodes of hypoglycaemia defined by investigator occurred with any treatment during the study .
CONCLUSIONS	Once-weekly SYR-472 treatment produced clinically and statistically significant improvements in glycaemic control in patients with type 2 diabetes .
CONCLUSIONS	It was well tolerated and might be a new treatment option for patients with this disease .
BACKGROUND	Takeda Pharmaceutical Company Limited .

###24347520
BACKGROUND	There is a lack of trials of psychodynamic treatments of depression in breast cancer patients .
BACKGROUND	The purpose of this trial was to determine the efficacy of short-term psychodynamic psychotherapy ( STPP ) in non-metastatic breast cancer patients diagnosed with depression , one of the most frequent mental comorbidities of breast cancer .
METHODS	In a multicenter prospective trial , 157 breast cancer patients with comorbid depression were randomized to either individual STPP ( intervention group , N = 78 ) or ` treatment as usual ' ( control group , TAU , N = 79 ) .
METHODS	As our primary outcome measure , we hypothesized a higher rate of remission defined as no diagnosis of depression ( Structured Clinical Interview for DSM-IV ) and reduction in depression score by at least 2 points ( Hospital Anxiety and Depression Scale , HADS-D ) in STPP versus TAU at treatment termination .
METHODS	Secondary outcomes mainly refer to quality of life ( QoL ) .
RESULTS	In the intention to treat ( ITT ) analysis , 44 % of the STPP group achieved highly significantly more remission than TAU ( 23 % ) .
RESULTS	STPP treatment ( OR = 7.64 ; P < 0.001 ) was the strongest predictor for remission post-treatment ; time was also significant ( OR = 0.96 ; P < 0.05 ) .
RESULTS	A high effect favoring STPP ( d = 0.82 ) was observed for the HADS-D score post-treatment ( secondary outcome ) .
RESULTS	Regarding further secondary outcomes ( QoL ) , analyses of covariance yielded main effects for group ( favoring STPP with an effect size of at least d = 0.5 ) for global QoL , role , emotional and social functioning , pain , treatment side-effects , breast symptoms and upset by hair loss .
CONCLUSIONS	STPP is an effective treatment of a broad range of depressive conditions in breast cancer patients improving depression and functional QoL .
CONCLUSIONS	Findings are limited by the drop-out rate ( 1/3 ) and delayed post-treatment assessments .
CONCLUSIONS	Future trials may consider stepped-care approaches , tailored to patients ' needs and requirements in the acute treatment phase .

###25290091
BACKGROUND	Two strategies to interrogate the insulin growth factor 1 receptor ( IGF-1R ) pathway were investigated : vertical inhibition with dalotuzumab and MK-2206 or ridaforolimus to potentiate PI3K pathway targeting and horizontal cross-talk inhibition with dalotuzumab and MK-0752 to exert effects against cellular proliferation , angiogenesis , and stem cell propagation .
METHODS	A phase I , multi-cohort dose escalation study was conducted in patients with advanced solid tumours .
METHODS	Patients received dalotuzumab ( 10mgkg ( -1 ) ) and escalating doses of MK-2206 ( 90-200mg ) or escalating doses of dalotuzumab ( 7.5-10mgkg ( -1 ) ) and MK-0752 ( 1800mg ) weekly .
METHODS	Upon maximum tolerated dose determination , patients with low-RAS signature , high-IGF1 expression ovarian cancer were randomised to dalotuzumab/MK -2206 versus dalotuzumab/ridaforolimus , whereas patients with high IGF1/low IGF2 expression colorectal cancer received dalotuzumab/MK -0752 .
RESULTS	A total of 47 patients were enrolled : 29 in part A ( 18 in the dalotuzumab/MK -2206 arm and 11 in the dalotuzumab/MK -0752 arm ) and 18 in part B ( 6 in each arm ) .
RESULTS	Dose-limiting toxicities ( DLTs ) for dalotuzumab/MK -2206 included grade 4 neutropenia and grade 3 serum sickness-like reaction , maculopapular rash , and gastrointestinal inflammation .
RESULTS	For dalotuzumab/MK -0752 , DLTs included grade 3 dehydration , rash , and diarrhoea .
RESULTS	Seven patients remained on study for > 4 cycles .
CONCLUSIONS	Dalotuzumab/MK -2206 and dalotuzumab/MK -0752 combinations were tolerable .
CONCLUSIONS	Further developments of prospectively validated predictive biomarkers to aid in patient selection for anti-IGF-1R therapies are needed .

###26161601
OBJECTIVE	The aim of this study was to evaluate clinical success of primary teeth class II lesions restored with different restorative materials [ Hybrid Composite Resin ( HCR ) , Resin Modified Glass Ionomer Cement ( RMGIC ) , compomer , and Giomer Composite Resin ( GCR ) ] followed up for 24 months .
METHODS	This study was carried out on 146 primary molars of 41 children in the age range of 5-7 years .
METHODS	The class II lesions in primary molars of a patient were restored using different restorative materials .
METHODS	Restorations were evaluated according to FDI-criteria and their survival rates were determined .
METHODS	Data were analysed with Pearson chi-square , Kaplan-Meier and Wilcoxon ( Breslow ) tests ( = 0.05 ) .
RESULTS	The failure rates of restorative materials were as follows : compomer 33.3 % , RMGIC 28.1 % , HCR 22.5 % and GCR 21.1 % .
CONCLUSIONS	While the functional failure was the most important factor in restorative material failure , RMGIC was the most successful material in terms of biological evaluation criterion and GCR had the longest survival rate .

###25088940
BACKGROUND	Cetuximab and bevacizumab have both been shown to improve outcomes in patients with metastatic colorectal cancer when added to chemotherapy regimens ; however , their comparative effectiveness when partnered with first-line fluorouracil , folinic acid , and irinotecan ( FOLFIRI ) is unknown .
BACKGROUND	We aimed to compare these agents in patients with KRAS ( exon 2 ) codon 12/13 wild-type metastatic colorectal cancer .
METHODS	In this open-label , randomised , phase 3 trial , we recruited patients aged 18-75 years with stage IV , histologically confirmed colorectal cancer , an Eastern Cooperative Oncology Group ( ECOG ) performance status of 0-2 , an estimated life expectancy of greater than 3 months , and adequate organ function , from centres in Germany and Austria .
METHODS	Patients were centrally randomised by fax ( 1:1 ) to FOLFIRI plus cetuximab or FOLFIRI plus bevacizumab ( using permuted blocks of randomly varying size ) , stratified according to ECOG performance status , number of metastatic sites , white blood cell count , and alkaline phosphatase concentration .
METHODS	The primary endpoint was objective response analysed by intention to treat .
METHODS	The study has completed recruitment , but follow-up of participants is ongoing .
METHODS	The trial is registered with ClinicalTrials.gov , number NCT00433927 .
RESULTS	Between Jan 23 , 2007 , and Sept 19 , 2012 , 592 patients with KRAS exon 2 wild-type tumours were randomly assigned and received treatment ( 297 in the FOLFIRI plus cetuximab group and 295 in the FOLFIRI plus bevacizumab group ) .
RESULTS	184 ( 620 % , 95 % CI 562-675 ) patients in the cetuximab group achieved an objective response compared with 171 ( 580 % , 521-637 ) in the bevacizumab group ( odds ratio 118 , 95 % CI 085-164 ; p = 018 ) .
RESULTS	Median progression-free survival was 100 months ( 95 % CI 88-108 ) in the cetuximab group and 103 months ( 98-113 ) in the bevacizumab group ( hazard ratio [ HR ] 106 , 95 % CI 088-126 ; p = 055 ) ; however , median overall survival was 287 months ( 95 % CI 240-366 ) in the cetuximab group compared with 250 months ( 227-276 ) in the bevacizumab group ( HR 077 , 95 % CI 062-096 ; p = 0017 ) .
RESULTS	Safety profiles were consistent with the known side-effects of the study drugs .
RESULTS	The most common grade 3 or worse adverse events in both treatment groups were haematotoxicity ( 73 [ 25 % ] of 297 patients in the cetuximab group vs 62 [ 21 % ] of 295 patients in the bevacizumab group ) , skin reactions ( 77 [ 26 % ] vs six [ 2 % ] ) , and diarrhoea ( 34 [ 11 % ] vs 40 [ 14 % ] ) .
CONCLUSIONS	Although the proportion of patients who achieved an objective response did not significantly differ between the FOLFIRI plus cetuximab and FOLFIRI plus bevacizumab groups , the association with longer overall survival suggests that FOLFIRI plus cetuximab could be the preferred first-line regimen for patients with KRAS exon 2 wild-type metastatic colorectal cancer .
BACKGROUND	Merck KGaA .

###25547247
BACKGROUND	Light information is the most important cue of circadian rhythm which synchronizes biological rhythm with external environment .
BACKGROUND	Circadian misalignment of biological rhythm and external environment is associated with increased risk of depression , insomnia , obesity , diabetes , cardiovascular disease , and cancer .
BACKGROUND	Increased light transmission by cataract surgery may improve circadian misalignment and related health outcomes .
BACKGROUND	Although some observational studies have shown improvement of depression and insomnia after cataract surgery , randomized controlled trials are lacking .
BACKGROUND	We will conduct a parallel-group , assessor-blinded , simple randomized controlled study comparing a cataract surgery group at three months after surgery with a control group to determine whether cataract surgery improves depressive symptoms , sleep quality , body mass regulation , and glucose and lipid metabolism .
METHODS	We will recruit patients who are aged 60 years and over , scheduled to receive their first cataract surgery , and have grade 2 or higher nuclear opacification as defined by the lens opacities classification system III .
METHODS	Exclusion criteria will be patients with major depression , severe corneal opacity , severe glaucoma , vitreous haemorrhage , proliferative diabetic retinopathy , macular oedema , age-related macular degeneration , and patients needing immediate or combined cataract surgery .
METHODS	After baseline participants will be randomized to two groups .
METHODS	Outcomes will be measured at three months after surgery among the intervention group , and three months after baseline among the control group .
METHODS	We will assess depressive symptoms as a primary outcome , using the short version geriatric depression scale ( GDS-15 ) .
METHODS	Secondary outcomes will be subjective and actigraph-measured sleep quality , sleepiness , glycated haemoglobin , fasting plasma glucose and triglyceride , low-density lipoprotein cholesterol , high-density lipoprotein cholesterol , body mass index , abdominal circumference , circadian rhythms of physical activity and wrist skin temperature , and urinary melatonin metabolite .
METHODS	Chronotype and visual function will be assessed using the ` morningness-eveningness ' questionnaire , the Munich chronotype questionnaire , and the National Eye Institute Visual Function Questionnaire .
CONCLUSIONS	Although there are potential limitations due to the difference in duration from baseline survey to outcome measurements between two groups , any seasonal effect on the outcome measurement will be balanced as a result of continuous inclusion of participants through the year , and outcomes will be adjusted for day length at outcome measurements at analysis .
BACKGROUND	UMIN000014559 , UMIN Clinical Trials Registry , registered on 15 July 2014 .

###24509270
OBJECTIVE	The objective of this study was to evaluate the safety and efficacy of the surgical versus transcatheter approach to correct perimembranous ventricular septal defects ( pmVSDs ) in a prospective , randomized , controlled clinical trial .
BACKGROUND	pmVSD is a common congenital heart disease in children .
BACKGROUND	Surgical closure of pmVSD is a well-established therapy but requires open-heart surgery with cardiopulmonary bypass .
BACKGROUND	Although the transcatheter approach is associated with significant incidence of complete atrioventricular block , it may provide a less invasive alternative .
BACKGROUND	Critical comparison of the safety and efficacy of the 2 interventions necessitates a prospective , randomized , controlled trial .
METHODS	Between January 2009 and July 2010 , 229 children with pmVSD were randomly assigned to surgical or transcatheter intervention .
METHODS	Clinical , laboratory , procedural , and follow-up data over a 2-year period were compared .
RESULTS	Neither group had mortality or major complications .
RESULTS	However , statistical analysis of the 2 groups demonstrated significant differences ( p < 0.001 ) in minor adverse events ( 32 vs. 7 ) , quantity of blood transfused , duration of the procedure , median hospital stay , median intensive care unit stay , median hospitalization cost , and median blood loss .
RESULTS	During a median follow-up of 2 years , the left ventricular end-diastolic dimension of both groups returned to normal and there was no difference in closure rate , adverse events , and complications between groups .
CONCLUSIONS	Transcatheter device closure and surgical repair are effective interventions with excellent midterm results for treating pmVSD in children .
CONCLUSIONS	Transcatheter device closure has a lower incidence of myocardial injury , less blood transfused , faster recovery , shorter hospital stay , and lower medical expenses .
CONCLUSIONS	( Transcatheter Closure Versus Surgery of Perimembranous Ventricular Septal Defects ; NCT00890799 ) .

###25015838
BACKGROUND	Sepsis sequelae include critical illness polyneuropathy , myopathy , wasting , neurocognitive deficits , post-traumatic stress disorder , depression and chronic pain .
BACKGROUND	Little is known howlong-term sequelae following hospital discharge are treated .
BACKGROUND	The aim of our study is to determine the effect of a primary care-based , long-term program on health-related quality of life in sepsis survivors .
METHODS	In a two-armed randomized multicenter interventional study , patients after sepsis ( n = 290 ) will be assessed at 6 , 12 and 24months .
METHODS	Patients are eligible if severe sepsis or septic shock ( ICD-10 ) , at least two criteria of systemic inflammatory response syndrome ( SIRS ) , at least one organ dysfunction and sufficient cognitive capacity are present .
METHODS	The intervention comprises 1 ) discharge management , 2 ) training of general practitioners and patients in evidence-based care for sepsis sequelae and 3 ) telephone monitoring of patients .
METHODS	At six months , we expect an improved primary outcome ( health-related quality of life/SF -36 ) and improved secondary outcomes such as costs , mortality , clinical - , psycho-social - and process-of-care measures in the intervention group compared to the control group .
CONCLUSIONS	This study evaluates a primary care-based , long-term program for patients after severe sepsis .
CONCLUSIONS	Study results may add evidence for improved sepsis care management .
CONCLUSIONS	General practitioners may contribute efficiently to sepsis aftercare .
BACKGROUND	U1111-1119-6345 .
BACKGROUND	DRKS00000741 , CCT-NAPN-20875 ( 25 February 2011 ) .

###24632280
OBJECTIVE	The aim of this study was to determine if ablation that targets patient-specific atrial fibrillation ( AF ) - sustaining substrates ( rotors or focal sources ) is more durable than trigger ablation alone at preventing late AF recurrence .
BACKGROUND	Late recurrence substantially limits the efficacy of pulmonary vein isolation for AF and is associated with pulmonary vein reconnection and the emergence of new triggers .
METHODS	Three-year follow-up was performed of the CONFIRM ( Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation ) trial , in which 92 consecutive patients with AF ( 70.7 % persistent ) underwent novel computational mapping .
METHODS	Ablation comprised source ( focal impulse and rotor modulation [ FIRM ] ) and then conventional ablation in 27 patients ( FIRM guided ) and conventional ablation alone in 65 patients ( FIRM blinded ) .
METHODS	Patients were followed with implanted electrocardiographic monitors when possible ( 85.2 % of FIRM-guided patients , 23.1 % of FIRM-blinded patients ) .
RESULTS	FIRM mapping revealed a median of 2 ( interquartile range : 1 to 2 ) rotors or focal sources in 97.7 % of patients during AF .
RESULTS	During a median follow-up period of 890 days ( interquartile range : 224 to 1,563 days ) , compared to FIRM-blinded therapy , patients receiving FIRM-guided ablation maintained higher freedom from AF after 1.2 0.4 procedures ( median 1 ; interquartile range : 1 to 1 ) ( 77.8 % vs. 38.5 % , p = 0.001 ) and a single procedure ( p < 0.001 ) and higher freedom from all atrial arrhythmias ( p = 0.003 ) .
RESULTS	Freedom from AF was higher when ablation directly or coincidentally passed through sources than when it missed sources ( p < 0.001 ) .
CONCLUSIONS	FIRM-guided ablation is more durable than conventional trigger-based ablation in preventing 3-year AF recurrence .
CONCLUSIONS	Future studies should investigate how ablation of patient-specific AF-sustaining rotors and focal sources alters the natural history of arrhythmia recurrence .
CONCLUSIONS	( The Dynamics of Human Atrial Fibrillation ; NCT01008722 ) .

###24732918
BACKGROUND	Verapamil is traditionally applied prophylactically in transradial procedures to prevent radial artery spasm .
BACKGROUND	However , verapamil may have side effects and is contraindicated in some clinical settings .
RESULTS	During an investigator-initiated , randomized , double-blind trial , we evaluated the need for preventive verapamil administration .
RESULTS	After vascular access was established , patients received either 5 mg verapamil ( n = 297 ) or placebo ( n = 294 ) .
RESULTS	We compared the rate of access site conversions as primary end point using a superiority margin of 5 % .
RESULTS	Occurrence of code breaks ( composite of conversions and unplanned use of verapamil ) , overall verapamil use , procedural and fluoroscopic times , contrast volume , and subjective pain were investigated as secondary end points .
RESULTS	The rate of access site conversions was not different in the 2 arms ( placebo 1.7 % versus verapamil 0.7 % , P = 0.28 , difference 1.0 % , 95 % CI for the difference -1.1 % to 3.3 % ) .
RESULTS	Proportion of code breaks was similar in the 2 groups ( 3.4 % versus 1.3 % , P = 0.11 ) , whereas overall verapamil use was markedly lower in the placebo arm ( 2.0 % versus 100 % , P < 0.0001 ) .
RESULTS	Procedural time ( median [ IQR ] 16.0 minutes [ 9.0 to 30.0 minutes ] versus 17.0 minutes [ 10.0 to 31.0 minutes ] , P = 0.37 ) , fluoroscopic time ( 4.4 minutes [ 2.1 to 9.6 minutes ] versus 4.8 minutes [ 2.4 to 10.7 minutes ] , P = 0.28 ) , contrast volume ( 72.5 mL [ 48.0 to 146.0 mL ] versus 75.5 mL [ 47.0 to 156.5 mL ] , P = 0.74 ) , and pain score ( P for trend = 0.12 ) were comparable in the 2 groups .
CONCLUSIONS	The preventive use of verapamil may be unnecessary for transradial procedures .
CONCLUSIONS	The omission of prophylactic verapamil may not only reduce the rate of potential complications related to the drug but also allow the safe extension of the transradial method to those with contraindications to verapamil .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01402427 .

###25633731
BACKGROUND	Although occult metastasis to lymph node in the lateral neck compartment is common in papillary thyroid carcinoma ( PTC ) , the clinical impact of these metastasis is unknown .
BACKGROUND	We hypothesized that sentinel lymph node biopsy ( SLNB ) of the lateral neck compartment with radioisotopes may detect occult metastasis , which could prevent recurrence .
METHODS	This randomized , controlled study was conducted from June 2009 to January 2011 and included 283 patients with PTC who were receiving treatment at the Samsung Medical Center .
RESULTS	Of the 283 patients enrolled in the study , 141 were randomized to a lateral SLNB ( LSLNB ) group and 142 patients were to the control group .
RESULTS	Lateral sentinel lymph nodes ( LSLNs ) were identified in 80 of the 127 patients ( 63.0 % ) for whom stimulated thyroglobulin ( sTg ) levels were available .
RESULTS	Among the 80 patients with LSLNs , 24 ( 30.0 % ) had metastases and underwent an ipsilateral modified radical neck dissection .
RESULTS	Among the 191 patients for whom repeated sTg test results were available , the first median level of sTg in the LSLNB study group was less compared with the control group ( P = .012 , adjusted for duration ) .
RESULTS	However , the second sTg level ( after the first radioactive iodine ablation ) was not different between the 2 groups .
RESULTS	Moreover , the sTg levels were not significantly different between the LSLN-positive ( n = 23 ) and other patients ( n = 168 ) after the first and second ablations .
RESULTS	During patient follow-up ( median , 39months ; range , 7-55 ) , 3 cases of recurrence were observed in the control group and 1 case in the study group ( a LSLN had not been detected in this case ) .
CONCLUSIONS	Although LSLNB was able to remove occult metastasis in PTC , this procedure had no effect on either sTg levels or on recurrence rates at a mean follow-up of 39months .
CONCLUSIONS	Additional long-term studies are needed to explore fully the clinical usefulness of LSLNB in the prevention of PTC recurrence .

###25601342
BACKGROUND	We aimed to compare overall survival after standard-dose versus high-dose conformal radiotherapy with concurrent chemotherapy and the addition of cetuximab to concurrent chemoradiation for patients with inoperable stage III non-small-cell lung cancer .
METHODS	In this open-label randomised , two-by-two factorial phase 3 study in 185 institutions in the USA and Canada , we enrolled patients ( aged 18 years ) with unresectable stage III non-small-cell lung cancer , a Zubrod performance status of 0-1 , adequate pulmonary function , and no evidence of supraclavicular or contralateral hilar adenopathy .
METHODS	We randomly assigned ( 1:1:1:1 ) patients to receive either 60 Gy ( standard dose ) , 74 Gy ( high dose ) , 60 Gy plus cetuximab , or 74 Gy plus cetuximab .
METHODS	All patients also received concurrent chemotherapy with 45 mg/m ( 2 ) paclitaxel and carboplatin once a week ( AUC 2 ) ; 2 weeks after chemoradiation , two cycles of consolidation chemotherapy separated by 3 weeks were given consisting of paclitaxel ( 200 mg/m ( 2 ) ) and carboplatin ( AUC 6 ) .
METHODS	Randomisation was done with permuted block randomisation methods , stratified by radiotherapy technique , Zubrod performance status , use of PET during staging , and histology ; treatment group assignments were not masked .
METHODS	Radiation dose was prescribed to the planning target volume and was given in 2 Gy daily fractions with either intensity-modulated radiation therapy or three-dimensional conformal radiation therapy .
METHODS	The use of four-dimensional CT and image-guided radiation therapy were encouraged but not necessary .
METHODS	For patients assigned to receive cetuximab , 400 mg/m ( 2 ) cetuximab was given on day 1 followed by weekly doses of 250 mg/m ( 2 ) , and was continued through consolidation therapy .
METHODS	The primary endpoint was overall survival .
METHODS	All analyses were done by modified intention-to-treat .
METHODS	The study is registered with ClinicalTrials.gov , number NCT00533949 .
RESULTS	Between Nov 27 , 2007 , and Nov 22 , 2011 , 166 patients were randomly assigned to receive standard-dose chemoradiotherapy , 121 to high-dose chemoradiotherapy , 147 to standard-dose chemoradiotherapy and cetuximab , and 110 to high-dose chemoradiotherapy and cetuximab .
RESULTS	Median follow-up for the radiotherapy comparison was 22.9 months ( IQR 27.5-33 .3 ) .
RESULTS	Median overall survival was 28.7 months ( 95 % CI 24.1-36 .9 ) for patients who received standard-dose radiotherapy and 20.3 months ( 17.7-25 .0 ) for those who received high-dose radiotherapy ( hazard ratio [ HR ] 1.38 , 95 % CI 1.09-1 .76 ; p = 0.004 ) .
RESULTS	Median follow-up for the cetuximab comparison was 21.3 months ( IQR 23.5-29 .8 ) .
RESULTS	Median overall survival in patients who received cetuximab was 25.0 months ( 95 % CI 20.2-30 .5 ) compared with 24.0 months ( 19.8-28 .6 ) in those who did not ( HR 1.07 , 95 % CI 0.84-1 .35 ; p = 0.29 ) .
RESULTS	Both the radiation-dose and cetuximab results crossed protocol-specified futility boundaries .
RESULTS	We recorded no statistical differences in grade 3 or worse toxic effects between radiotherapy groups .
RESULTS	By contrast , the use of cetuximab was associated with a higher rate of grade 3 or worse toxic effects ( 205 [ 86 % ] of 237 vs 160 [ 70 % ] of 228 patients ; p < 0.0001 ) .
RESULTS	There were more treatment-related deaths in the high-dose chemoradiotherapy and cetuximab groups ( radiotherapy comparison : eight vs three patients ; cetuximab comparison : ten vs five patients ) .
RESULTS	There were no differences in severe pulmonary events between treatment groups .
RESULTS	Severe oesophagitis was more common in patients who received high-dose chemoradiotherapy than in those who received standard-dose treatment ( 43 [ 21 % ] of 207 patients vs 16 [ 7 % ] of 217 patients ; p < 0.0001 ) .
CONCLUSIONS	74 Gy radiation given in 2 Gy fractions with concurrent chemotherapy was not better than 60 Gy plus concurrent chemotherapy for patients with stage III non-small-cell lung cancer , and might be potentially harmful .
CONCLUSIONS	Addition of cetuximab to concurrent chemoradiation and consolidation treatment provided no benefit in overall survival for these patients .
BACKGROUND	National Cancer Institute and Bristol-Myers Squibb .

###25677354
OBJECTIVE	The authors evaluated the potential of methylphenidate to improve antidepressant response to citalopram , as assessed by clinical and cognitive outcomes , in elderly depressed patients .
METHODS	The authors conducted a 16-week randomized double-blind placebo-controlled trial for geriatric depression in 143 older outpatients diagnosed with major depression comparing treatment response in three treatment groups : methylphenidate plus placebo ( N = 48 ) , citalopram plus placebo ( N = 48 ) , and citalopram plus methylphenidate ( N = 47 ) .
METHODS	The primary outcome measure was change in depression severity .
METHODS	Remission was defined as a score of 6 or less on the Hamilton Depression Rating Scale .
METHODS	Secondary outcomes included measures of anxiety , apathy , quality of life , and cognition .
RESULTS	Daily doses ranged from 20 mg to 60 mg for citalopram ( mean = 32 mg ) and from 5 mg to 40 mg for methylphenidate ( mean = 16 mg ) .
RESULTS	All groups showed significant improvement in depression severity and in cognitive performance .
RESULTS	However , the improvement in depression severity and the Clinical Global Impressions improvement score was more prominent in the citalopram plus methylphenidate group compared with the other two groups .
RESULTS	Additionally , the rate of improvement in the citalopram plus methylphenidate group was significantly higher than that in the citalopram plus placebo group in the first 4 weeks of the trial .
RESULTS	The groups did not differ in cognitive improvement or number of side effects .
CONCLUSIONS	Combined treatment with citalopram and methylphenidate demonstrated an enhanced clinical response profile in mood and well-being , as well as a higher rate of remission , compared with either drug alone .
CONCLUSIONS	All treatments led to an improvement in cognitive functioning , although augmentation with methylphenidate did not offer additional benefits .

###24373307
OBJECTIVE	We evaluated an alternative administration route , reduced schedule priming series , and increased intervals between booster doses for anthrax vaccine adsorbed ( AVA ) .
OBJECTIVE	AVA 's originally licensed schedule was 6 subcutaneous ( SQ ) priming injections administered at months ( m ) 0 , 0.5 , 1 , 6 , 12 and 18 with annual boosters ; a simpler schedule is desired .
METHODS	Through a multicenter randomized , double blind , non-inferiority Phase IV human clinical trial , the originally licensed schedule was compared to four alternative and two placebo schedules .
METHODS	8-SQ group participants received 6 SQ injections with m30 and m42 `` annual '' boosters ; participants in the 8-IM group received intramuscular ( IM ) injections according to the same schedule .
METHODS	Reduced schedule groups ( 7-IM , 5-IM , 4-IM ) received IM injections at m0 , m1 , m6 ; at least one of the m0 .5 , m12 , m18 , m30 vaccine doses were replaced with saline .
METHODS	All reduced schedule groups received a m42 booster .
METHODS	Post-injection blood draws were taken two to four weeks following injection .
METHODS	Non-inferiority of the alternative schedules was compared to the 8-SQ group at m2 , m7 , and m43 .
METHODS	Reactogenicity outcomes were proportions of injection site and systemic adverse events ( AEs ) .
RESULTS	The 8-IM group 's m2 response was non-inferior to the 8-SQ group for the three primary endpoints of anti-protective antigen IgG geometric mean concentration ( GMC ) , geometric mean titer , and proportion of responders with a 4-fold rise in titer .
RESULTS	At m7 anti-PA IgG GMCs for the three reduced dosage groups were non-inferior to the 8-SQ group GMCs .
RESULTS	At m43 , 8-IM , 5-IM , and 4-IM group GMCs were superior to the 8-SQ group .
RESULTS	Solicited injection site AEs occurred at lower proportions in the IM group compared to SQ. .
RESULTS	Route of administration did not influence the occurrence of systemic AEs .
RESULTS	A 3 dose IM priming schedule with doses administered at m0 , m1 , and m6 elicited long term immunological responses and robust immunological memory that was efficiently stimulated by a single booster vaccination at 42 months .
CONCLUSIONS	A priming series of 3 intramuscular doses administered at m0 , m1 , and m6 with a triennial booster was non-inferior to more complex schedules for achieving antibody response .

###24351100
OBJECTIVE	To compare acute normovolemic hemodilution versus low central venous pressure strategy versus conventional fluid management in reducing intraoperative estimated blood loss , hematocrit drop and need for blood transfusion in patients undergoing radical retropubic prostatectomy under general anesthesia .
METHODS	Patients undergoing radical retropubic prostatectomy under general anesthesia were randomized to conventional fluid management , acute normovolemic hemodilution or low central venous pressure ( 5mmHg ) .
METHODS	Treatment effects on estimated blood loss and hematocrit change were tested in multivariable regression models accounting for surgeon , prostate size , and all two-way interactions .
RESULTS	Ninety-two patients completed the study .
RESULTS	Estimated blood loss ( meanSD ) was significantly lower with low central venous pressure ( 706362ml ) compared to acute normovolemic hemodilution ( 1103635ml ) and conventional ( 1051714ml ) groups ( p = 0.0134 ) .
RESULTS	There was no difference between the groups in need for blood transfusion , or hematocrit drop from preoperative values .
RESULTS	The multivariate model predicting estimated blood loss showed a significant effect of treatment ( p = 0.0028 ) and prostate size ( p = 0.0323 ) , accounting for surgeon ( p = 0.0013 ) .
RESULTS	In the model predicting hematocrit change , accounting for surgeon difference ( p = 0.0037 ) , the treatment effect depended on prostate size ( p = 0.0007 ) with the slope of low central venous pressure differing from the other two groups .
RESULTS	Hematocrit was predicted to drop more with increased prostate size in acute normovolemic hemodilution and conventional groups but not with low central venous pressure .
CONCLUSIONS	Limitations include the inability to blind providers to group assignment , possible variability between providers in estimation of blood loss , and the relatively small sample size that was not powered to detect differences between the groups in need for blood transfusion .
CONCLUSIONS	Maintaining low central venous pressure reduced estimated blood loss compared to conventional fluid management and acute normovolemic hemodilution in patients undergoing radical retropubic prostatectomy but there was no difference in allogeneic blood transfusion between the groups .

###24743155
BACKGROUND	Vitamin D deficiency is associated with reduced lung function .
BACKGROUND	Cathelicidin , an antimicrobial peptide regulated by vitamin D , plays a role within the innate immune system .
BACKGROUND	The association of cathelicidin with lung function decrement and respiratory infection is undefined .
BACKGROUND	We determined the independent relationship of cathelicidin with lung function .
METHODS	In a cross-sectional analysis of 650 participants in an urban observational cohort with high smoking prevalence , plasma 25 ( OH ) - vitamin D and cathelicidin levels were measured from stored samples obtained within 6 months of spirometry study visits .
METHODS	Multivariable linear regression was used to determine the independent association between low cathelicidin ( defined as the lowest quartile of the cohort ) and absolute forced expiratory volume in 1 second ( FEV1 ) .
RESULTS	The mean age of the cohort was 49 years ; 91 % were black , 35 % female and 41 % HIV-infected .
RESULTS	Participants with low cathelicidin had a 183 mL lower FEV1 compared to higher cathelicidin ( p = 0.009 ) ; this relationship was maintained ( 115 ml lower ; p = 0.035 ) after adjusting for demographics , BMI , and smoking .
RESULTS	Neither HIV serostatus , heavy smoking history , nor 25 ( OH ) - vitamin D levels were associated with cathelicidin levels .
RESULTS	Participants with low cathelicidin had a greater prevalence of prior bacterial pneumonia ( 21 % versus 14 % ; p = 0.047 ) .
RESULTS	Inclusion of pneumonia in adjusted models did not substantially reduce the FEV1 decrement observed with low cathelicidin ( 104 mL lower FEV1 ; p = 0.05 ) .
RESULTS	Lung function decrements associated with low cathelicidin were greatest among individuals with lower 25 ( OH ) - vitamin D levels .
CONCLUSIONS	In a cohort at risk for airflow obstruction , low cathelicidin was independently associated with lower FEV1 .
CONCLUSIONS	These clinical data support a mechanistic link between 25 ( OH ) - vitamin D deficiency and lung function impairment , independent of pneumonia risk .

###24679882
OBJECTIVE	We compared the outcome of retrograde intrarenal surgery monotherapy vs shock wave lithotripsy for stones 10 to 20 mm in preschool children .
METHODS	This prospective study included 60 children with a mean SD age of 2.4 1.3 years .
METHODS	Patients were randomly divided into 2 groups .
METHODS	Group 1 underwent shock wave lithotripsy and group 2 underwent retrograde intrarenal surgery as monotherapy .
METHODS	Retrograde intrarenal surgery was started using a 7.5 Fr semirigid ureteroscope ( Storz ) and the holmium laser , and completed by the Flex X2 flexible ureterorenoscope .
METHODS	A ureteral access sheath was not used and only hydrodilatation was performed .
METHODS	Patients were evaluated preoperatively by ultrasound and plain abdominopelvic x-ray .
METHODS	Followup was 3 months .
RESULTS	The stone-free rate after a single session treatment was 70 % and 86.6 % in groups 1 and 2 , respectively .
RESULTS	Mean operative time was 27.9 3.5 and 40 7.8 minutes , mean fluoroscopy exposure time was 60 42 and 50 35 seconds , and mean hospital stay was 6 2 and 12 8 hours , respectively .
RESULTS	No major complication occurred in either group and no child in either group received blood transfusion .
RESULTS	Nine group 1 patients needed a second shock wave lithotripsy session , of whom 2 required a third session .
RESULTS	At 3 months the overall stone-free rate was 93.3 % and 96.6 % in groups 1 and 2 , respectively .
CONCLUSIONS	Retrograde intrarenal surgery is an option for treating medium sized renal stones in preschool children with results comparable to those of shock wave lithotripsy and a safe short-term outcome .

###25382402
BACKGROUND	Data on the potent pleiotropic extraskeletal effects of vitamin D have renewed interest in its use in selected populations , including patients with chronic kidney disease , but the available data are still insufficient to make recommendations .
BACKGROUND	This study assessed the long-term effect of small cholecalciferol doses on serum vitamin D , parathormone ( PTH ) , and bone mineral density ( BMD ) in hemodialysis patients .
METHODS	Nineteen patients with serum 25 ( OH ) D < 20 ng/mL were randomized into cholecalciferol ( 2000 IU 3/week ) and no-treatment groups , then observed for 1 year .
METHODS	Patients with hypercalcemia , hyperphosphatemia , and receiving vitamin D/calcimimetics were excluded .
METHODS	Serum 25 ( OH ) D , 1,25 ( OH ) 2D , PTH , and alkaline phosphatase activity were examined every 2 months and BMD was measured before and after the study .
RESULTS	We observed normalization of serum 25 ( OH ) D with an increase in medians from 11.3 to 44.9 ng/mL ( P = 0.02 ) in the cholecalciferol group and no change in the controls ( P < 0.001 ) .
RESULTS	Simultaneously , median serum 1,25 ( OH ) 2D increased from 18.2 to 43.1 pmol/L ( P = 0.02 ) in the cholecalciferol group and from 10.6 to 21.2 pmol/L ( P = 0.02 ) in controls ( P = 0.013 ) .
RESULTS	The treatment was associated with a small increase in serum calcium , but serum phosphate , PTH , alkaline phosphatase , and BMD remained unchanged in both groups .
CONCLUSIONS	Oral cholecalciferol at a dose of 2000 IU/3/week is an effective and safe way to treat vitamin D deficiency in hemodialysis patients , leading to a significant increase in serum 1,25 ( OH ) 2D .
CONCLUSIONS	However , it was insufficient to suppress the activity of parathyroid glands or to significantly change BMD .

###25124503
OBJECTIVE	Specific parental behaviors and cognitions are associated with child anxiety .
OBJECTIVE	Studies informing us of the directionality of the associations are lacking .
OBJECTIVE	We investigated the effect of parental involvement in children 's anxiety treatment on parental behaviors and cognitions .
METHODS	Children ( N = 54 , 7-12 years ) and parents were randomly allocated to different treatment groups ( involved , not involved ) .
METHODS	Observed behavior , self-reported behavior and cognitions were assessed separately for mothers and fathers at pre - , posttreatment and follow-up .
RESULTS	There were no differences over time for self-reported parental efficacy and observed negativity , but self-reported autonomy granting increased for both groups over time .
RESULTS	Differential effects were found between groups for observed paternal over-involvement ( fathers involved in treatment showed a more rapid decrease ) and self-reported maternal autonomy-granting ( non-involved mothers showed a greater increase ) .
CONCLUSIONS	Our findings suggest that child anxiety significantly influences parental behaviors and cognitions .
CONCLUSIONS	Child therapy may successfully change the family system .

###24969718
OBJECTIVE	To observe the effect of two different ways of subglottic secretion drainage on the incidence of ventilator-associated pneumonia .
METHODS	A total of 149 patients receiving mechanical ventilation from October 2007 to February 2010 in our hospital were enrolled in our study .
METHODS	According to the random number table , they were divided into 3 groups : a control group ( 47 ) , a intermittent drainage group ( 54 ) , and a continuous drainage group ( 48 ) .
METHODS	There was no significant difference in APACHE II score before intubation in the patients of the 3 groups .
METHODS	Conventional treatment and care was performed in the control group , while subglottic rinse was performed every 4 h in the intermittent drainage group and continuous aspiration in the continuous drainage group .
METHODS	The incidence and mortality of ventilator-associated pneumonia were compared among groups within 30 days after intubation .
METHODS	The tolerance and complications were observed .
RESULTS	The incidence rate of early onset ventilator-associated pneumonia in the intermittent drainage group ( 13.0 % ) and the continuous drainage group ( 14.6 % ) was significantly lower than that in the control group ( 40.4 % ) , and the difference was statistically significant ( ( 2 ) = 9.914 , 7.978 ;P = 0.002,0.005 ) , but there was no difference between the former 2 groups ( ( 2 ) = 0.056 ; P = 0.812 ) .
RESULTS	There was no significant difference in the incidence of late-onset ventilator-associated pneumonia or mortality among groups ( P > 0.05 ) .
RESULTS	Good tolerance of the 2 methods was observed .
CONCLUSIONS	Subglottic secretion drainage by both the intermittent and the continuous methods can efficiently prevent early onset ventilator-associated pneumonia .

###25646323
BACKGROUND	Compared with nonaerated , isocaloric controls , aerated foods can reduce appetite throughout an entire dieting day .
BACKGROUND	Increased gastric volumes and delayed emptying are possible but unexplored mechanisms .
OBJECTIVE	We tested the hypothesis that aerated drinks ( foams ) of differing gastric stability would increase gastric distension and reduce appetite compared with a control drink .
METHODS	In a randomized , balanced , crossover trial , 18 healthy male participants consumed the following 3 skimmed-milk-based test products ( all 110 kcal ) : 2 drinks aerated to foams by whipping ( to 490 mL ) , one drink that was stable in the stomach [ stable foam ( SF ) ] , and one drink that was less stable in the stomach [ less-stable foam ( LSF ) ] , and a nonaerated drink [ liquid control ( LC ) ; 140 mL ] .
METHODS	Over 4 h , stomach contents ( foam , air , and liquid ) were imaged using magnetic resonance imaging ( MRI ) , and self-reported appetite ratings were collected and quantified by the area under the curve or time to return to baseline ( TTRTB ) .
RESULTS	Compared with the LC , both foams caused significantly increased gastric volumes and reduced hunger ( all P < 0.001 ) .
RESULTS	Compared with the LSF , SF further produced a significantly slower decrease in the total gastric content ( P < 0.05 ) and foam volume ( P < 0.0001 ) and a longer TTRTB ( 197 compared with 248 min , respectively ; P < 0.05 ) , although the hunger AUC was not statistically different .
RESULTS	Results for other appetite scales were similar .
CONCLUSIONS	With this MRI trial , we provide novel insights on the gastrointestinal behavior of aerated drinks by measuring separate volumes of foam , liquid , and air layers in the stomach .
CONCLUSIONS	Appetite suppression induced by foams could largely be explained by effects on gastric volumes and emptying , which may be further enhanced by foam stability .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01690182 .

###25733461
BACKGROUND	Casein is considered a slowly digestible protein compared with whey protein , and this may cause differences in hormone responses and the kinetics of delivering amino acids into the circulation .
OBJECTIVE	We investigated whether postprandial plasma hormone and metabolite responses were different when bovine casein or whey protein was co-administered with carbohydrates in healthy and prediabetic adults .
METHODS	White healthy male adults ( n = 15 ) and white , well-defined male and female prediabetic adults ( n = 15 ) received test drinks randomly on 3 different occasions at least 2 d apart which contained 50 g of maltodextrin19 ( MD19 ) alone or in combination with 50 g of whey protein isolate ( WPI ) or 50 g of sodium caseinate ( SC ) .
METHODS	Blood samples were collected over a 240-min time period and were analyzed for hormone profiles and defined metabolites .
RESULTS	No evidence was found that gastric emptying was different between the 2 protein drinks .
RESULTS	Both proteins increased peak plasma insulin concentrations in prediabetic persons by 96 % compared with MD19 ( each , P < 0.05 ) , which was accompanied by a reduction of peak venous blood glucose by 21 % ( each , P < 0.0001 ) without a difference between the 2 proteins .
RESULTS	Peak plasma glucagon concentrations increased by 101 % in both groups after the protein drinks ( P < 0.05 ) .
RESULTS	The WPI drink also increased peak plasma glucose-dependent insulinotropic polypeptide concentrations in healthy volunteers by 56 % ( P < 0.01 ) .
RESULTS	Differences in plasma metabolite concentrations in volunteers could be attributed exclusively to the differences in the amino acid composition of the 2 proteins ingested .
CONCLUSIONS	The WPI and the SC drinks similarly reduced postprandial glucose excursions when ingested with carbohydrates in healthy and prediabetic volunteers .
CONCLUSIONS	Under our experimental conditions , however , no evidence was found that gastrointestinal processing of the 2 protein varieties differed substantially .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as DRKS00005682 .

###24300152
OBJECTIVE	To explore the effects of statins upon bone mineral density ( BMD ) and bone metabolic markers in postmenopausal women with hypercholesterolemia .
METHODS	A prospective study was conducted for 100 women receiving treatment from January 2011 to August 2012 and meeting the inclusion criteria of osteopenia or osteoporosis with hypercholesterolemia postmenopausal .
METHODS	They were randomly divided into treatment group on atorvastatin 10 mg once daily and control group .
METHODS	The parameters of lumbar BMD , bone resorption markers of type I collagen cross-linked C-telopeptide ( CTX ) , bone synthesis markers procollagen type I N-terminal peptide ( PINP ) were compared between two groups after half a year and one year .
RESULTS	There was an upward trend of lumbar spine BMD and PINP in the treatment group at half a year and one year compared with the control group .
RESULTS	And two groups had significant difference ( P < 0.05 ) .
RESULTS	Although two groups had no significant difference in all parameters at half a year , the values of lumbar spine BMD and PINP were higher in the treatment group at one year than the control group .
RESULTS	Two groups had significant difference ( P < 0.05 ) .
CONCLUSIONS	Statins can help maintain or increase bone mass of hypercholesterolemic menopausal women through promoting bone synthesis .

###24655701
BACKGROUND	Feedback from active locomotor muscles contributes to the exercise pressor response in healthy humans , and is thought to be more prominent in heart failure ( HF ) .
BACKGROUND	The purpose of this study was to examine the influence of metaboreflex stimulation on arterial pressure in HF .
METHODS	Eleven HF patients ( 51 5 years , New York Heart Association Class I/II , left ventricular ejection fraction 32 3 % ) and 11 controls ( 42 3 years ) were recruited .
METHODS	Participants completed two exercise sessions on separate days : ( 1 ) symptom limited graded exercise test ; and ( 2 ) constant work rate cycling ( 60 % peak oxygen consumption , VO2 ) for 4 minutes with 2 minutes passive recovery .
METHODS	Recovery was randomized to normal or locomotor muscle regional circulatory occlusion ( RCO ) .
METHODS	Mean arterial pressure ( MAP ) , systolic pressure ( SBP ) , diastolic pressure , heart rate ( HR ) and VO2 were measured at rest , end-exercise and recovery .
METHODS	O2 pulse ( VO2/HR ) and the rate pressure product ( RPP = HR SBP ) were calculated .
RESULTS	In response to RCO , mean arterial pressure and SBP increased in HF compared with CTLs ( 6.8 5.8 % vs -3.0 7.8 % , P < .01 and 3.4 6.4 % vs -12.7 10.4 % , P < .01 , respectively ) , with no difference in diastolic pressure ( P = .61 ) .
RESULTS	HF patients had a smaller reduction in HR and RPP , but also displayed a larger decrease in O2 pulse consequent to locomotor metaboreflex stimulation ( P < .05 , for all ) .
CONCLUSIONS	RCO resulted in a markedly increased pressor response in HF relative to controls , due primarily to an increase of SBP and attenuated cardiac recovery as noted by the persistent elevation in HR .

###25658816
BACKGROUND	The most common modality used to address acute inflammation is cryotherapy .
BACKGROUND	Whereas pain decreases with cryotherapy , evidence that changes occur in perfusion of skeletal muscle is limited .
BACKGROUND	We do not know whether ice attenuates the increases in perfusion associated with acute inflammation .
OBJECTIVE	To examine the effects of repeated applications of ice bags on perfusion of the gastrocnemius muscle after an eccentric exercise protocol .
METHODS	Controlled laboratory study .
METHODS	Laboratory .
METHODS	Eighteen healthy participants ( 3 men , 15 women ; age = 22.2 2.2 years , height = 166.0 11.9 cm , mass = 69.4 25.0 kg ) .
METHODS	To induce eccentric muscle damage , participants performed 100 unilateral heel-lowering exercises off a step to the beat of a metronome .
METHODS	A randomized intervention ( cryotherapy , sham , control ) was applied to the exercised lower extremity immediately after the protocol and again at 10 , 24 , and 34 hours after the protocol .
METHODS	Baseline perfusion measurements ( blood volume , blood flow , and blood flow velocity ) were taken using contrast-enhanced ultrasound of the exercised leg .
METHODS	Perfusion was reassessed after the first intervention and 48 hours after the protocol as percentage change scores .
METHODS	Pain was measured with a visual analog scale at baseline and at 10 , 24 , 34 , and 48 hours after the protocol .
METHODS	Separate repeated-measures analyses of variance were used to assess each dependent variable .
RESULTS	We found no interactions among interventions for microvascular perfusion .
RESULTS	Blood volume and blood flow , however , increased in all conditions at 48 hours after exercise ( P < .001 ) , and blood flow velocity decreased postintervention from baseline ( P = .041 ) .
RESULTS	We found a time-by-intervention interaction for pain ( P = .009 ) .
RESULTS	Visual analog scale scores were lower for the cryotherapy group than for the control group at 34 and 48 hours after exercise .
CONCLUSIONS	Whereas eccentric muscle damage resulted in increased blood flow , ice did not decrease muscle perfusion 48 hours after exercise .
CONCLUSIONS	Therefore , ice does not seem to decrease muscle perfusion when blood flow is elevated , as it would be during inflammation .

###24509055
OBJECTIVE	Stimulant medications , such as methylphenidate ( MPH ) , improve the academic performance of children with attention-deficit hyperactivity disorder ( ADHD ) .
OBJECTIVE	However , the mechanism by which MPH exerts an effect on academic performance is unclear .
OBJECTIVE	We examined MPH effects on math performance and investigated possible mediation of MPH effects by changes in time on-task , inhibitory control , selective attention , and reaction time variability .
METHODS	Children with ADHD aged 7 to 11 years ( N = 93 ) completed a timed math worksheet ( with problems tailored to each individual 's level of proficiency ) and 2 neuropsychological tasks ( Go/No-Go and Child Attention Network Test ) at baseline , then participated in a 4-week , randomized , controlled , titration trial of MPH .
METHODS	Children were then randomly assigned to their optimal MPH dose or placebo for 1 week ( administered double-blind ) and repeated the math and neuropsychological tasks ( posttest ) .
METHODS	Baseline and posttest videorecordings of children performing the math task were coded to assess time on-task .
RESULTS	Children taking MPH completed 23 more math problems at posttest compared to baseline , whereas the placebo group completed 24 fewer problems on posttest versus baseline , but the effects on math accuracy ( percent correct ) did not differ .
RESULTS	Path analyses revealed that only change in time on-task was a significant mediator of MPH 's improvements in math productivity .
CONCLUSIONS	MPH-derived math productivity improvements may be explained in part by increased time spent on-task , rather than improvements in neurocognitive parameters , such as inhibitory control , selective attention , or reaction time variability .

###24373641
OBJECTIVE	We have developed nanoparticle - cyclodextrin dexamethasone ( DexNP ) and dorzolamide ( DorzNP ) eye drops that provide sustained high drug concentrations on the eye surface .
OBJECTIVE	To test these characteristics , we measured dexamethasone and dorzolamide levels in tear fluid in humans following eye drop administration .
METHODS	Concentration of dexamethasone was measured by mass spectrometry .
METHODS	One drop of DexNP was instilled into one eye .
METHODS	Tear fluid was sampled with microcapillary pipettes at seven time-points after drop instillation .
METHODS	Control eyes received Maxidex ( ) ( dexamethasone ) .
METHODS	The same procedure was performed for dorzolamide with DorzNP and Trusopt ( ) .
RESULTS	Six subjects were included in each group .
RESULTS	The peak concentration ( g/mlstandard deviation ) of dexamethasone for DexNP eye drops ( 636.6399.1 ) was up to 19-fold higher than with Maxidex ( ) ( 39.318.9 ) ( p < 0.001 ) .
RESULTS	At 4hr , DexNP was still 10 times higher than Maxidex ( ) .
RESULTS	In addition , DexNP resulted in about 30-fold higher concentration of dissolved dexamethasone in the tear fluid of extended time period allowing more drug to partition into the eye tissue .
RESULTS	The overall concentration of dorzolamide was about 50 % higher for DorzNP ( 59.576.9 ) than Trusopt ( ) ( 40.076.7 ) ( p < 0.05 ) .
CONCLUSIONS	The results indicate high and extended concentration of dissolved dexamethasone with DexNP , which can explain the greater and longer lasting effect of dexamethasone in the cyclodextrin nanoparticle drug delivery platform .
CONCLUSIONS	Dexamethasone seems to fit the cyclodextrin nanoparticle suspension drug delivery platform with longer duration and higher concentrations in tear fluid than available commercial drops , while dorzolamide is less suitable .

###24365552
METHODS	Subtherapeutic plasma isoniazid ( INH ) concentrations and the development of bacterial resistance may be attributed to poor quality and reduced bioavailability of fixed-dose combination ( FDC ) formulations .
METHODS	The bioavailability of INH from a generic and that of a branded FDC formulation had not been compared in the Mexican population .
OBJECTIVE	To evaluate the bioequivalence of a generic three-drug FDC formulation ( 3FDC ) in comparison with a 3FDC reference with doses of 300 mg INH in 20 healthy Mexican adults , and to generate data regarding the oral relative bioavailability of the drug in this population .
METHODS	A single-dose , randomised-sequence , open-label , two-period crossover study .
RESULTS	Both formulations were well tolerated .
RESULTS	The pharmacokinetic parameters of INH showed wide inter-individual variability .
RESULTS	The average relative bioavailability calculated for maximum serum concentration area under the concentration-time curve ( AUC ) , AUC ( 0-24h ) and AUC ( 0 - ) of the test 3FDC formulation vs. the 3FDC reference were respectively 64.84 % ( 90 % CI 56.01-75 .06 ) , 59.05 % ( 90 % CI 50.27-69 .36 ) and 57.26 % ( 90 % CI 46.93-69 .84 ) .
CONCLUSIONS	The 3FDC test and reference formulations were not bioequivalent because the 90 % CI for the geometric mean ratios did not meet the regulatory requirements for bioequivalence ( range 80-125 % ) based on the rate and extent of absorption .

###25072617
OBJECTIVE	To compare bone mineral density ( BMD ) changes over 96 weeks in adults virologically failing standard first-line therapy , randomized to raltegravir plus lopinavir/ritonavir ( RAL + LPV/r ) or conventional 2-3 nucleoside/nucleotide reverse transcriptase inhibitors [ N ( t ) RTIs ] + LPV/r second-line therapy .
METHODS	Participants underwent dual-energy x-ray absorptiometry at baseline and weeks 48 and 96 to measure total hip and lumbar spine BMD .
METHODS	Analyses were adjusted for gender , body mass index , and smoking .
METHODS	Linear regression was used to compare between-group differences , logistic regression for low BMD ( hip or spine Z-score -2 ) incidence , and multivariate linear regression to determine predictors of BMD change .
METHODS	This work represents the extension and final results of the previously published initial 48 weeks of the study .
RESULTS	The population included 210 adults from 5 middle-income countries : 52 % females , 52 % Asians , 43 % Africans , mean age , 39 years ( SD , 8 years ) .
RESULTS	In the 2-3 N ( t ) RTI group ( vs. RAL ) , BMD reduction was greater at the spine ( mean change , -4.9 % vs. -3.5 % ; adjusted difference , -1.9 % ; 95 % confidence interval : -3.3 to -0.5 % , P = 0.009 ) and hip ( -4.1 % vs. -2.2 % ; -1.9 % ; -3.4 to -0.4 ; P = 0.012 ) .
RESULTS	BMD decrease was greatest at 48 weeks with stabilization to week 96 .
RESULTS	Overall , low BMD occurred in 15 participants ( 7.9 % ) , with no between-group differences .
RESULTS	Independent predictors for bone loss included lower body mass index ( regression coefficient : hip , -0.18 % and spine , -0.26 % per 1 kg/m ) , longer tenofovir exposure ( hip , -0.74 % and spine , -1.0 % per year ) , greater change in CD4 to week 12 ( hip , -5.11 % per 10-fold higher ) , and higher baseline HIV-RNA ( spine , -0.7 % per 10-fold higher ) .
CONCLUSIONS	Over 96 weeks , there was greater BMD decrease with 2-3 N ( t ) RTI + LPV/r compared with RAL + LPV/r ; the relative decrease at the spine was greater than the hip .
CONCLUSIONS	BMD decreases with second-line antiretroviral therapy largely occurred in the first 48 weeks with stabilization , but no recovery thereafter .

###25037579
BACKGROUND	Because early life growth has long-lasting metabolic and behavioral consequences , intervention during this period of developmental plasticity may alter long-term obesity risk .
BACKGROUND	While modifiable factors during infancy have been identified , until recently , preventive interventions had not been tested .
BACKGROUND	The Intervention Nurses Starting Infants Growing on Healthy Trajectories ( INSIGHT ) .
BACKGROUND	Study is a longitudinal , randomized , controlled trial evaluating a responsive parenting intervention designed for the primary prevention of obesity .
BACKGROUND	This `` parenting '' intervention is being compared with a home safety control among first-born infants and their parents .
BACKGROUND	INSIGHT 's central hypothesis is that responsive parenting and specifically responsive feeding promotes self-regulation and shared parent-child responsibility for feeding , reducing subsequent risk for overeating and overweight .
METHODS	316 first-time mothers and their full-term newborns were enrolled from one maternity ward .
METHODS	Two weeks following delivery , dyads were randomly assigned to the `` parenting '' or `` safety '' groups .
METHODS	Subsequently , research nurses conduct study visits for both groups consisting of home visits at infant age 3-4 , 16 , 28 , and 40 weeks , followed by annual clinic-based visits at 1 , 2 , and 3 years .
METHODS	Both groups receive intervention components framed around four behavior states : Sleeping , Fussy , Alert and Calm , and Drowsy .
METHODS	The main study outcome is BMI z-score at age 3 years ; additional outcomes include those related to patterns of infant weight gain , infant sleep hygiene and duration , maternal responsiveness and soothing strategies for infant/toddler distress and fussiness , maternal feeding style and infant dietary content and physical activity .
METHODS	Maternal outcomes related to weight status , diet , mental health , and parenting sense of competence are being collected .
METHODS	Infant temperament will be explored as a moderator of parenting effects , and blood is collected to obtain genetic predictors of weight status .
METHODS	Finally , second-born siblings of INSIGHT participants will be enrolled in an observation-only study to explore parenting differences between siblings , their effect on weight outcomes , and carryover effects of INSIGHT interventions to subsequent siblings .
CONCLUSIONS	With increasing evidence suggesting the importance of early life experiences on long-term health trajectories , the INSIGHT trial has the ability to inform future obesity prevention efforts in clinical settings .
BACKGROUND	NCT01167270 .
BACKGROUND	Registered 21 July 2010 .

###25393172
OBJECTIVE	We evaluated the effectiveness of offering adjunctive financial incentives for abstinence ( contingency management [ CM ] ) within a safety net hospital smoking cessation program .
METHODS	We randomized participants ( n = 146 ) from a Dallas County , Texas , Tobacco Cessation Clinic from 2011 to 2013 to usual care ( UC ; cessation program ; n = 71 ) or CM ( UC + 4 weeks of financial incentives ; n = 75 ) , and followed from 1 week before the quit date through 4 weeks after the quit date .
METHODS	A subset ( n = 128 ) was asked to attend a visit 12 weeks after the scheduled quit date .
RESULTS	Participants were primarily Black ( 62.3 % ) or White ( 28.1 % ) and female ( 57.5 % ) .
RESULTS	Most participants were uninsured ( 52.1 % ) and had an annual household income of less than $ 12000 ( 55.5 % ) .
RESULTS	Abstinence rates were significantly higher for those assigned to CM than UC at all visits following the quit date ( all Ps < .05 ) .
RESULTS	Point prevalence abstinence rates in the CM and UC groups were 49.3 % versus 25.4 % at 4 weeks after the quit date and 32.8 % versus 14.1 % at 12 weeks after the quit date .
RESULTS	CM participants earned an average of $ 63.40 ( $ 150 possible ) for abstinence during the first 4 weeks after the scheduled quit date .
CONCLUSIONS	Offering small financial incentives for abstinence might be an effective means to improve abstinence rates among socioeconomically disadvantaged individuals participating in smoking cessation treatment .

###24792107
OBJECTIVE	To evaluate the change of epithelial and flap thickness after femtosecond laser-assisted in situ keratomileusis ( LASIK ) using spectral-domain optical coherence tomography ( SD OCT ) in correlation with the spherical equivalent refraction treated and clinical outcomes .
METHODS	Prospective , randomized , contralateral-eye study .
METHODS	Forty myopic eyes underwent LASIK using an excimer laser with refraction ranging from -1.00 to -7.25 diopters ( mean -3.251.9 ) .
METHODS	Flap creation was randomized between eyes , using the IntraLASE FS60 laser ( IL ) in 1 eye and WaveLight FS200 laser ( FS ) in the contralateral eye .
METHODS	SD OCT was used to evaluate the epithelial and flap thickness profiles and corneal power preoperatively and at 1 week and 1 , 3 , and 9 months postoperatively .
METHODS	Manifest and wavefront refractions were performed at each postoperative visit .
RESULTS	Statistically significant epithelial thickening was observed in both IL and FS groups as early as 1 month postoperatively ( P = .033 and P = .042 ) , but this stabilized between 3 ( P = .042 and P = .035 ) and 9 months ( P = .043 and P = .041 ) .
RESULTS	Femtosecond-LASIK flaps were thicker in the IL group in comparison to the FS group at 3 and 9 months postoperatively ( P = .003 and P = .005 , respectively ) .
RESULTS	There was a statistically significant correlation between the magnitude of preoperative myopic refraction and the central epithelial thickness at 1 , 3 , and 9 months ( Pearson correlation coefficients 0.485 , 0.587 and 0.576 ) ( P = .0021 , P = .0010 , and P = .0011 ) , respectively .
RESULTS	SD OCT corneal power maps showed steepening at 3 and 9 months along with mild myopic shift .
CONCLUSIONS	Progressive epithelial and flap thickening with increased corneal power were observed after femtosecond laser-assisted in situ keratomileusis for myopia with consequent stabilization between 3 to 9 months postoperatively .
CONCLUSIONS	The magnitude of epithelial and flap thickness remodeling correlated to the preoperative myopic refractive error .

###24885178
BACKGROUND	The objective of this research project is to understand and to improve workers ' recovery from work stress .
BACKGROUND	Although recovery during lunch breaks is the most common within-workday break , it has received only minor research attention .
BACKGROUND	Therefore , we will study whether lunch breaks including a relaxation session or exposure to nature have more favorable outcomes than usually spent lunch breaks concerning : a ) recovery processes , b ) health , c ) well-being , d ) job performance and e ) creativity .
BACKGROUND	We approach recovery by combining the theoretical frameworks of work and environmental psychology .
METHODS	We conduct an intervention study in a sample of 268 knowledge-workers who engage in different lunch break activities for 15-minutes per day , two weeks in a row .
METHODS	We randomly assign participants to three experimental conditions : 1 ) exposure to nature , 2 ) relaxation and 3 ) control group ( lunch break spent as usual ) .
METHODS	Online questionnaires before and after the intervention assess long term changes regarding recovery processes and the major outcome variables .
METHODS	Before , during and after the intervention , SMS and paper-pencil questionnaires measure the same constructs four times a day with fewer items .
METHODS	We also measure blood pressure and collect saliva samples to map cortisol excretion across the intervention period .
METHODS	A timed experimental task ( i.e. , the Alternative Uses Task ) is used to examine differences in creativity between the three groups after the intervention period .
CONCLUSIONS	By combining the knowledge of work and environmental psychology about recovery and restorative experiences , by merging three recovery perspectives ( settings , processes , and outcomes ) and by using data triangulation , we produce valid results that broaden our view on mechanisms underlying recovery and enhance our understanding about their links to psychological , behavioural and physiological outcomes , resulting in a more comprehensive picture of work stress recovery in general .
BACKGROUND	ClinicalTrials.gov Protocol Registration System NCT02124837 .
BACKGROUND	Registered 24 April 2014 .

###24352479
BACKGROUND	Rheumatoid arthritis ( RA ) is one of the most prevalent autoimmune diseases worldwide .
BACKGROUND	Some researchers have suggested that the serum vitamin D ( VitD ) level may relate to disease activity .
BACKGROUND	The current study was designed to identify the correlation between vitaminD prescription and prevention of relapses in rheumatoid arthritis .
METHODS	A double blinded , randomized controlled trial study was performed using 80RA patients .
METHODS	RA was controlled and patients were in remission during the past 2months .
METHODS	Serum level of VitD in the studied patients was below 30ng/dl .
METHODS	Patients were randomly allocated to receive VitD or placebo .
METHODS	In the 6-month follow-up period , the Disease Activity Score 28 ( DAS28 ) was used in case of relapses as an index of RA activity to compare the two groups .
RESULTS	The flare rate was not different between two groups ( p > 0.05 ) .
RESULTS	The odds ratio of the rate of decline in patients of the trial group compared with the control group was 1.17 ( not significant ; p > 0.05 ) .
RESULTS	The mean DAS28 between the two patient groups was not significant ( p > 0.05 ) .
CONCLUSIONS	A low VitD level was not identified to be a risk factor for RA severity or flare ups ; however , although not statistically significant , VitD treatment might be clinically effective .
CONCLUSIONS	Further studies are needed with more emphasis on the issue of cost effectiveness and clinical importance to provide more information .

###24287500
OBJECTIVE	The CX3CR1 gene is implicated as a candidate gene for age-related macular degeneration ( AMD ) through several lines of evidence .
OBJECTIVE	There is uncertainty , however , as to whether common genetic variants in CX3CR1 alter risk of AMD , since prior studies have been inconsistent and mostly limited to evaluation of 2 nonsynonymous variants , T280M ( rs3732378 ) and V249I ( rs3732379 ) .
OBJECTIVE	To determine if common variants in CX3CR1 predict future risk of AMD .
METHODS	Prospective nested case-control study within 5 large study populations with long-term follow-up .
METHODS	We measured genotypes for T280M , V249I , and 13 other common single-nucleotide polymorphisms ( SNPs ) of the CX3CR1 gene among people who developed AMD ( n = 1110 , including 369 with neovascular AMD ) and 2532 age - and sex-matched controls .
METHODS	We determined the incidence rate ratios ( RR ) and 95 % CIs for incidence of AMD for each variant and examined interactions with other AMD-associated variants and modifiable risk factors .
RESULTS	In additive genetic models , we identified nonsignificant associations with AMD for T280M ( RR , 0.87 ; P = .07 ) and 3 other SNPs , rs2853707 ( RR , 0.88 ; P = .07 ) , rs12636547 ( RR , 0.85 ; P = .10 ) , and rs1877563 ( RR , 0.84 ; P = .06 ) , 1 of which , rs2853707 , is positioned in the CX3CR1 promoter region and was associated with neovascular AMD ( RR , 0.75 ; P = .03 ) .
RESULTS	We observed that a recessive model was a better fit to the data for some SNPs , with associations between rs11715522 and AMD ( RR , 1.27 ; P = .03 ) and between rs2669845 ( RR , 3.10 ; P = .04 ) , rs2853707 ( RR , 0.48 ; P = .050 ) , and rs9868689 ( RR , 0.31 ; P = .02 ) and neovascular AMD .
RESULTS	Moreover , in exploratory analyses , we identified a number of possible interactions including between V249I and rs2669845 and dietary intake of -3 fatty acids ( P = .004 and P = .009 , respectively ) for AMD ; between rs2669845 and obesity ( P = .03 ) for neovascular AMD ; between T280M and complement component 3 ( C3 ) R102G for AMD ( P = .03 ) ; between rs2669845 and Y402H in complement factor H for AMD ( P = .04 ) ; and between rs2669845 , rs2853707 , and V249I and C3 R102G for neovascular AMD ( P = .008 ; .04 ; and .002 , respectively ) .
CONCLUSIONS	This study failed to identify significant associations between common CX3CR1 variants and AMD after considering the number of SNPs analyzed and multiple comparisons .
CONCLUSIONS	However , we observed evidence consistent with recessive modes of association and that an effect of CX3CR1 variants may depend on other factors including dietary intake of -3 fatty acids , obesity , and genotypes at CFH Y402H and C3 R102G .
CONCLUSIONS	If replicated in other populations , these findings would support a role for CX3CR1 in AMD but also suggest that its role may involve mechanisms that are independent of the T280M/V249I variations .

###24577019
BACKGROUND	Successful application of noninvasive ventilation ( NIV ) for acute respiratory failure ( ARF ) requires patient cooperation and comfort .
BACKGROUND	The efficacy and safety of early IV dexmedetomidine when added to protocolized , as-needed IV midazolam and fentanyl remain unclear .
METHODS	Adults with ARF and within 8 h of starting NIV were randomized to receive IV dexmedetomidine ( 0.2 g/kg/h titrated every 30 min to 0.7 g/kg/h to maintain a Sedation-Agitation Scale [ SAS ] score of 3 to 4 ) or placebo in a double-blind fashion up to 72 h , until NIV was stopped for 2 h , or until intubation .
METHODS	Patients with agitation ( SAS 5 ) or pain ( visual analog scale 5 of 10 cm ) 15 min after each dexmedetomidine and placebo increase could receive IV midazolam 0.5 to 1.0 mg or IV fentanyl 25 to 50 g , respectively , at a minimum interval of every 3 h.
RESULTS	The dexmedetomidine ( n = 16 ) and placebo ( n = 17 ) groups were similar at baseline .
RESULTS	Use of early dexmedetomidine did not improve NIV tolerance ( score , 1 of 4 ; OR , 1.44 ; 95 % CI , 0.44-4 .70 ; P = .54 ) nor , vs. placebo , led to a greater median ( interquartile range ) percent time either tolerating NIV ( 99 % [ 61 % -100 % ] vs. 67 % [ 40 % -100 % ] , P = .56 ) or remaining at the desired sedation level ( SAS score = 3 or 4 , 100 % [ 86 % -100 % ] vs. 100 % [ 100 % -100 % ] , P = .28 ] , or fewer intubations ( P = .79 ) .
RESULTS	Although use of dexmedetomidine was associated with a greater duration of NIV vs placebo ( 37 [ 16-72 ] vs. 12 [ 4-22 ] h , P = .03 ) , the total ventilation duration ( NIV + invasive ) was similar ( 3.3 [ 2-4 ] days vs. 3.8 [ 2-5 ] days , P = .52 ) .
RESULTS	More patients receiving dexmedetomidine had one or more episodes of deep sedation vs placebo ( SAS 2 , 25 % vs. 0 % , P = .04 ) .
RESULTS	Use of midazolam ( P = .40 ) and episodes of either severe bradycardia ( heart rate 50 beats/min , P = .18 ) or hypotension ( systolic BP 90 mm Hg , P = .64 ) were similar .
CONCLUSIONS	Initiating dexmedetomidine soon after NIV initiation in patients with ARF neither improves NIV tolerance nor helps to maintain sedation at a desired goal .
CONCLUSIONS	Randomized , multicenter trials targeting patients with initial intolerance are needed to further elucidate the role for dexmedetomidine in this population .

###24847723
OBJECTIVE	It is recommended to wait at least 1 min between blood pressure ( BP ) readings .
OBJECTIVE	However , there is insufficient evidence on the utility of this recommendation using a validated automatic device .
OBJECTIVE	The aim was to assess differences in BP according to the waiting time between BP readings .
METHODS	The study was designed as a cross-sectional descriptive study in hypertensive patients attended in primary care.Patients were seated for 5 min before six baseline BP readings : three BP measurements with no waiting time [ immediate readings ( IR ) ] between them and three BP measurements with 1 min of waiting time [ waiting readings ( WR ) ] between each reading , in random order .
METHODS	The intraclass correlation coefficient was calculated between IR and WR mean BP measurements , with 95 % confidence intervals ( CIs ) .
RESULTS	We included 150 hypertensive patients , 49.3 % women , 65.6 ( 12.8 ) years of age .
RESULTS	The mean systolic blood pressure ( SBP ) values for IR and WR measurements were 137.2 ( 95 % CI 134.2-140 .2 ) and 137.8 ( 95 % CI 134.8-140 .8 ) mmHg , respectively .
RESULTS	The mean diastolic blood pressure ( DBP ) values for IR and WR measurements were 79.4 ( 95 % CI 77.5-81 .4 ) and 79.7 ( 95 % CI 77.7-81 .8 ) mmHg , respectively .
RESULTS	Intraclass correlation coefficient between IR and WR was 0.959 ( 95 % CI 0.943-0 .970 ) and 0.926 ( 95 % CI 0.898-0 .946 ) for SBP and DBP , respectively .
RESULTS	The mean difference between both methods for SBP and DBP was -0.60 ( 95 % CI -1.79 to 0.5 ) and -0.27 ( 95 % CI -1.33 to 0.77 ) mmHg , respectively .
CONCLUSIONS	We found a good agreement between waiting or not waiting 1 min between office BP readings .
CONCLUSIONS	This demonstrates that both methods of BP measurement appear to be interchangeable .

###24532111
OBJECTIVE	The study aim was to compare the incidence of esophageal injuries between different temperature probes in the monitoring of esophageal temperature during atrial fibrillation ( AF ) ablation .
METHODS	One hundred patients with drug-resistant AF were prospectively and randomly assigned into two groups according to the esophageal temperature probe used : the multi-thermocouple probe group ( n = 50 ) and the deflectable temperature probe group ( n = 50 ) .
METHODS	Extensive pulmonary vein ( PV ) isolation was performed with a 3.5-mm open irrigated tip ablation catheter by using a radiofrequency ( RF ) power of 25-30 W.
METHODS	In both groups , the esophageal temperature thermocouple was placed on the area of the esophagus adjacent to the ablation site .
METHODS	When the esophageal temperature reached 42 C , the RF energy delivery was stopped .
METHODS	Esophageal endoscopy was performed 1 day after the catheter ablation .
RESULTS	No differences existed between the two groups in terms of clinical background and various parameters related to the catheter ablation , including RF delivery time and number of RF deliveries at an esophageal temperature of > 42 C. Esophageal lesions , such as esophagitis and esophageal ulcers , occurred in 10/50 ( 20 % ) and 15/50 ( 30 % ) patients in the multi-thermocouple and deflectable temperature probe groups , respectively ( P = 0.25 ) .
RESULTS	Most lesions were mild to moderate injuries , and all were cured using conservative treatment .
CONCLUSIONS	The incidence of esophageal injury was almost equal between the multi-thermocouple temperature probe and the deflectable temperature probe during esophageal temperature monitoring .
CONCLUSIONS	Most of the esophageal lesions that developed during esophageal temperature monitoring were mild to moderate and reversible .

###25307195
BACKGROUND	Low-income Latinas ( Hispanics ) face risk for cardiovascular disease due to high rates of overweight/obesity , sedentary lifestyle , and other factors .
BACKGROUND	Limited access to health care and language barriers may prevent delivery of health promotion messages .
BACKGROUND	Targeted approaches , including the integration of community health workers , may be required to promote healthy lifestyle and prevent chronic disease in underserved ethnic minority groups .
BACKGROUND	The term commonly used to refer to female community health workers in Latino communities is `` promotora ( s ) . ''
OBJECTIVE	This study evaluates the outcomes and feasibility of a promotora-led lifestyle behavior intervention for overweight , immigrant Latinas .
METHODS	A community prevention model was employed in planning and implementing this study .
METHODS	A randomized controlled trial design was used .
METHODS	A Community Advisory Board provided expertise in evaluating feasibility of study implementation in the community and other important guidance .
METHODS	The sample was comprised of 223 women aged 35-64 years , predominantly with low income and 8th grade education .
METHODS	The culturally tailored Lifestyle Behavior Intervention included group education ( 8 classes based upon Su Corazon , Su Vida ) , followed by 4 months of individual teaching and coaching ( home visits and telephone calls ) .
METHODS	The control group received a comparable length educational program and follow-up contacts .
METHODS	Evaluations were conducted at baseline and at 6 and 9 months using a dietary habits questionnaire , accelerometer readings of physical activity , and clinical measures ( body mass index , weight , waist circumference , blood pressure , lipids , blood glucose ) .
METHODS	Data were collected between January 2010 and August 2012 .
RESULTS	Women in the intervention group improved significantly in dietary habits , waist circumference , and physical activity in comparison to those in the control group .
RESULTS	A treatment dosage effect was observed for weight and waist circumference .
RESULTS	Knowledge about heart disease increased .
RESULTS	High attendance at classes and participation in the individual teaching and counseling sessions and high retention rates support the feasibility and acceptability of the promotora-led lifestyle behavior intervention .
CONCLUSIONS	Our findings demonstrate that lifestyle behaviors and other risk factors of overweight Latina women may be improved through a promotora-led lifestyle behavior intervention .
CONCLUSIONS	Feasibility of implementing this intervention in community settings and engaging promotoras as facilitators is supported .

###24231454
BACKGROUND	Somatic mutations in PIK3CA ( phosphatidylinositol-4 ,5 - bisphosphonate 3-kinase [ PI3K ] , catalytic subunit alpha gene ) activate the PI3K-AKT signaling pathway and contribute to pathogenesis of various malignancies , including colorectal cancer .
METHODS	We examined associations of PIK3CA oncogene mutation with relapse , survival , and treatment efficacy in 627 stage III colon carcinoma case subjects within a randomized adjuvant chemotherapy trial ( 5-fluorouracil and leucovorin [ FU/LV ] vs irinotecan [ CPT11 ] , fluorouracil and leucovorin [ IFL ] ; Cancer and Leukemia Group B 89803 [ Alliance ] ) .
METHODS	We detected PIK3CA mutation in exons 9 and 20 by polymerase chain reaction and pyrosequencing .
METHODS	Cox proportional hazards model was used to assess prognostic and predictive role of PIK3CA mutation , adjusting for clinical features and status of routine standard molecular pathology features , including KRAS and BRAF mutations and microsatellite instability ( mismatch repair deficiency ) .
METHODS	All statistical tests were two-sided .
RESULTS	Compared with PIK3CA wild-type cases , overall status of PIK3CA mutation positivity or the presence of PIK3CA mutation in either exon 9 or 20 alone was not statistically significantly associated with recurrence-free , disease-free , or overall survival ( log-rank P > .70 ; P > .40 in multivariable regression models ) .
RESULTS	There was no statistically significant interaction between PIK3CA and KRAS ( or BRAF ) mutation status in survival analysis ( P ( interaction ) > .18 ) .
RESULTS	PIK3CA mutation status did not appear to predict better or worse response to IFL therapy compared with FU/LV therapy ( P ( interaction ) > .16 ) .
CONCLUSIONS	Overall tumor PIK3CA mutation status is not associated with stage III colon cancer prognosis .
CONCLUSIONS	PIK3CA mutation does not appear to serve as a predictive tumor molecular biomarker for response to irinotecan-based adjuvant chemotherapy .

###24964392
BACKGROUND	Darunavir requires pharmacokinetic enhancement to increase its bioavailability .
BACKGROUND	Cobicistat is potentially an alternative pharmacokinetic booster to ritonavir .
BACKGROUND	Bioequivalence of a darunavir/cobicistat fixed-dose combination ( FDC ) versus darunavir and cobicistat co-administered as single agents and the effect of a high-fat meal on the pharmacokinetics of the FDC were evaluated .
METHODS	In this Phase I , open-label , randomized , three-panel , crossover study ( NCT01619527 ) , healthy volunteers received a single dose of darunavir ( 800 mg ) with cobicistat ( 150 mg ) as either an FDC or as single agents co-administered under fasted ( panel 1 , n = 74 ) or fed ( breakfast , panel 2 , n = 40 ) conditions , or as the FDC under fasted versus fed ( high-fat breakfast ) conditions ( panel 3 , n = 19 ) , with a 7 day washout period between treatments .
METHODS	Pharmacokinetic profiles , safety and tolerability were assessed .
RESULTS	90 % confidence intervals of the least square mean ratios for darunavir and cobicistat maximum plasma concentration and area under the plasma concentration-time curve ( AUC ) were all within 80.00 % and 125.00 % in panels 1 and 2 .
RESULTS	Administration of the FDC with a high-fat breakfast significantly increased darunavir maximum plasma concentration 2.27-fold and AUC 1.63-1 .70 - fold , whereas cobicistat pharmacokinetics were unaffected .
RESULTS	No volunteers discontinued due to adverse events ( AEs ) .
RESULTS	All AEs were grade 1 or 2 .
RESULTS	Overall , 27 ( 20 % ) and 26 ( 20 % ) volunteers had 1 AE at least possibly related to darunavir and cobicistat , respectively .
CONCLUSIONS	Bioequivalence of the darunavir/cobicistat 800/150-mg FDC was demonstrated versus darunavir and cobicistat co-administered as single agents under fasted or fed conditions .
CONCLUSIONS	Food increased darunavir exposure , therefore , darunavir/cobicistat should be administered with food .

###24729068
OBJECTIVE	This study investigated the prevalence of driven exercise ( DE ) and its role in treatment outcome for adolescents with bulimia nervosa ( BN ) and anorexia nervosa ( AN ) .
METHODS	Participants were 201 adolescents with an eating disorder ( ED ) ( 80 with BN and 121 with AN ) presenting for outpatient treatment at two specialist clinics .
METHODS	All adolescents participated in one of two randomized controlled trials .
METHODS	Descriptive statistics were conducted to evaluate the presence and frequency of baseline DE .
METHODS	Exploratory hierarchical regressions were used to evaluate the effect of baseline DE on treatment outcomes .
RESULTS	About 66.3 % of adolescents with BN and 23.1 % of adolescents with AN presented with baseline DE .
RESULTS	The presence of baseline DE predicted significantly worse outcomes for adolescents with AN in terms of ED symptom severity ( ps < .004 ) ; however , baseline DE did not significantly predict any of the evaluated outcomes for adolescents with BN ( ps < .05 ) .
CONCLUSIONS	The results of this secondary exploratory data suggest that DE is prevalent for adolescents with BN and AN .
CONCLUSIONS	However , DE may be related to different constructs for adolescents with AN than those with BN , suggesting differences in treatment needs .

###26299236
BACKGROUND	In the SAFE-PCI for Women trial , patient preference for radial access for future procedures was greater than for femoral access .
BACKGROUND	We sought to assess whether radial or femoral access impacts formal measures of quality-of-life ( QOL ) among women undergoing cardiac catheterization .
METHODS	We assessed QOL using European quality of life-5 dimensions ( EQ-5D ) and EQ visual analog scale ( EQ-VAS ) scores among 304 women randomized to radial or femoral arteriotomy in the SAFE-PCI for Women trial at sites with QOL substudy approval .
METHODS	Patient surveys were administered at baseline , hospital discharge , and 30 days ( for percutaneous coronary intervention patients ) .
RESULTS	Women randomized to both treatments had similar EQ-5D index and EQ-VAS scores at baseline , hospital discharge , and 30-day follow-up .
RESULTS	After adjustment for baseline scores , there was no effect of assigned treatment on EQ-5D ( discharge 0.004 ; 95 % CI -0.03 to 0.04 ; 30 days -0.03 ; 95 % CI -0.09 to 0.02 ) or EQ-VAS ( discharge -1.31 ; 95 % CI -4.74 to 2.12 ; 30 days -2.10 ; 95 % CI -8.92 to 4.71 ) scores .
RESULTS	At discharge , 60.5 % versus 63.5 % ( P = .60 ) of patients in radial and femoral groups were free from access site pain ; at 30 days , rates were 85.7 % versus 77.6 % ( P = .30 ) , respectively .
RESULTS	Patient preference for the same access strategy for repeat procedures was greater in the radial versus femoral group ( 77.2 % vs 26.8 % ; P < .0001 ) .
CONCLUSIONS	Using established QOL instruments , we did not measure any difference in QOL or functional status according to access site strategy in women undergoing cardiac catheterization , yet patient preference for the radial approach was significantly greater .
CONCLUSIONS	Other factors influencing patient choice for radial access should be investigated .

###25230076
OBJECTIVE	To assess and compare the effects of four simultaneous-image multifocal contact lenses ( SIMCLs ) , and those with distant-vision-only contact lenses on visual performance in early presbyopes , under dim conditions , including the effects of induced glare .
METHODS	In this double-masked crossover study design , 28 presbyopic subjects aged 40 to 46 years were included .
METHODS	All participants were fitted with the four different SIMCLs ( Air Optix Aqua Multifocal [ AOAM ; Alcon ] , PureVision Multifocal [ PM ; Bausch & Lomb ] , Acuvue Oasys for Presbyopia [ AOP ; Johnson & Johnson Vision ] , and Biofinity Multifocal [ BM ; CooperVision ] ) and with monofocal contact lenses ( Air Optix Aqua , Alcon ) .
METHODS	After 1 month of daily contact lens wearing , each subject 's binocular distance visual acuity ( BDVA ) and binocular distance contrast sensitivity ( BDCS ) were measured using the Functional Visual Analyzer ( Stereo Optical Co. , Inc. ) under mesopic conditions ( 3 candela [ cd ] / m ) both with no glare and under the 2 levels of induced glare : 1.0 lux ( glare 1 ) and 28 lux ( glare 2 ) .
RESULTS	Among the SIMCLs , in terms of BDVA , AOAM and PM outperformed BM and AOP .
RESULTS	All contact lenses performed better at level without glare , followed by Glare 1 , and with the worst results obtained under glare 2 .
RESULTS	Binocular distance contrast sensitivity revealed statistically significant differences for 12 cycles per degree ( cpd ) .
RESULTS	Among the SIMCLs , post hoc multiple comparison testing revealed that AOAM and PM provided the best BDCS at the three luminance levels .
RESULTS	In both cases , BDVA and BDCS at 12 cpd , monofocal contact lenses outperformed all SIMCL ones at all lighting conditions .
CONCLUSIONS	Air Optix Aqua Multifocal and PM provided better visual performance than BM and AOP for distance vision with low addition and under dim conditions , but they all provide worse performance than monofocal contact lenses .

###24590636
OBJECTIVE	Previous research incorporating yoga ( YG ) into radiotherapy ( XRT ) for women with breast cancer finds improved quality of life ( QOL ) .
OBJECTIVE	However , shortcomings in this research limit the findings .
METHODS	Patients with stages 0 to III breast cancer were recruited before starting XRT and were randomly assigned to YG ( n = 53 ) or stretching ( ST ; n = 56 ) three times a week for 6 weeks during XRT or waitlist ( WL ; n = 54 ) control .
METHODS	Self-report measures of QOL ( Medical Outcomes Study 36-item short-form survey ; primary outcomes ) , fatigue , depression , and sleep quality , and five saliva samples per day for 3 consecutive days were collected at baseline , end of treatment , and 1 , 3 , and 6 months later .
RESULTS	The YG group had significantly greater increases in physical component scale scores compared with the WL group at 1 and 3 months after XRT ( P = .01 and P = .01 ) .
RESULTS	At 1 , 3 , and 6 months , the YG group had greater increases in physical functioning compared with both ST and WL groups ( P < .05 ) , with ST and WL differences at only 3 months ( P < .02 ) .
RESULTS	The group differences were similar for general health reports .
RESULTS	By the end of XRT , the YG and ST groups also had a reduction in fatigue ( P < .05 ) .
RESULTS	There were no group differences for mental health and sleep quality .
RESULTS	Cortisol slope was steepest for the YG group compared with the ST and WL groups at the end ( P = .023 and P = .008 ) and 1 month after XRT ( P = .05 and P = .04 ) .
CONCLUSIONS	YG improved QOL and physiological changes associated with XRT beyond the benefits of simple ST exercises , and these benefits appear to have long-term durability .

###24941816
OBJECTIVE	To evaluate the effectiveness of combined use of propofol and ketamine for total intravenous anesthesia ( TIVA ) in adults and to determine their optimal doses .
METHODS	100 adults with general anesthesia were randomly divided into five groups [ K0 , K0 .5 , K1 , K1 .5 and K2 , with 0 , 0.5 , 1 , 1.5 and 2 mg / ( kg x h ) ketamine , respectively ] .
METHODS	The dose of propofol administered during surgery and hemodynamics , respiratory recovery time , awakening time , steward score of recovery and adverse reactions of the patients were recorded .
METHODS	Ten patients from each group were randomly chosen to have plasma concentrations of propofol and ketamine examined .
RESULTS	The dose of propofol and total price of the two drugs decreased with the increase of dosage of ketamine ( P < 0.05 ) .
RESULTS	Better outcomes in recovery indexes and adverse reactions were observed in Group K1 compared with those in Group K1 .5 and K2 ( P < 0.05 ) .
RESULTS	Plasma concentrations of ketamine in Group K1 , K1 .5 and K2 were higher than those in Group K0 .5 ( P < 0.05 ) .
RESULTS	Regression analyses showed a positive correlation between ` dose of ketamine and operation time ' and ` respiratory recovery time and awakening time ' and a negative correlation between ` dose of ketamine and operation time ' and ` steward score of recovery ' .
RESULTS	` Dose of ketamine ' was also associated with dreams , asleep after awakening , nystagmus and visual changes .
RESULTS	The dose ratio of ketamine and propofol was associated with dizzy and adverse reactions .
CONCLUSIONS	Continuous pump infusion of 1 mg / ( kg x h ) ketamine for TIVA in adults can reduce dosage of propofol and minimize adverse effects of ketamine .

###24220555
OBJECTIVE	Gemcitabine requires transporter proteins to cross cell membranes .
OBJECTIVE	Low expression of human equilibrative nucleoside transporter-1 ( hENT1 ) may result in gemcitabine resistance in pancreatic ductal adenocarcinoma ( PDAC ) .
OBJECTIVE	CO-101 , a lipid-drug conjugate of gemcitabine , was rationally designed to enter cells independently of hENT1 .
OBJECTIVE	We conducted a randomized controlled trial to determine whether CO-101 improved survival versus gemcitabine in patients with metastatic PDAC ( mPDAC ) with low hENT1 .
OBJECTIVE	The study also tested the hypothesis that gemcitabine is more active in patients with mPDAC tumors with high versus low hENT1 expression .
METHODS	Patients were randomly assigned to CO-101 or gemcitabine , after providing a metastasis sample for blinded hENT1 assessment .
METHODS	An immunohistochemistry test measuring tumor hENT1 was developed .
METHODS	To dichotomize the population , an hENT1 cutoff value was defined using primary PDAC samples from an adjuvant trial , and a high/low cutoff was applied .
METHODS	The primary end point was overall survival ( OS ) in the low hENT1 subgroup .
RESULTS	Of 367 patients enrolled , hENT1 status was measured in 358 patients ( 97.5 % ) .
RESULTS	Two hundred thirty-two ( 64.8 % ) of 358 patients were hENT1 low .
RESULTS	There was no difference in OS between treatments in the low hENT1 subgroup or overall , with hazard ratios ( HRs ) of 0.994 ( 95 % CI , 0.746 to 1.326 ) and 1.072 ( 95 % CI , 0.856 to 1.344 ) , respectively .
RESULTS	The toxicity profiles in both arms were similar .
RESULTS	Within the gemcitabine arm , there was no difference in survival between the high and low hENT1 subgroups ( HR , 1.147 ; 95 % CI , 0.809 to 1.626 ) .
CONCLUSIONS	CO-101 is not superior to gemcitabine in patients with mPDAC and low tumor hENT1 .
CONCLUSIONS	Metastasis hENT1 expression did not predict gemcitabine outcome .

###24399452
OBJECTIVE	Afatinib is a potent , irreversible , ErbB family blocker in clinical development for the treatment of advanced non-small cell lung cancer , metastatic head and neck cancer , and other solid tumours .
OBJECTIVE	As afatinib is a substrate for the P-glycoprotein ( P-gp ) pump transporter the three studies presented here investigated the pharmacokinetics of afatinib in the presence of a potent inhibitor ( ritonavir ) or inducer [ rifampicin ( rifampin ) ] of P-gp .
METHODS	We conducted phase I , open-label , single-centre studies in healthy male volunteers who received a single once-daily oral dose of afatinib ( 20 or 40 mg ) together with either ritonavir or rifampicin ; two studies had a randomised , two - and three-way crossover design and the third was a non-randomised , two-period sequential study .
RESULTS	When afatinib 20 mg was administered 1 h after ritonavir , afatinib geometric mean ( gMean ) maximum plasma concentration ( C max ) and area under the plasma concentration-time curve from time zero to infinity ( AUC ) increased by 38.5 and 47.6 % , respectively .
RESULTS	Coadministration of ritonavir either simultaneously or 6 h later than afatinib 40 mg resulted in minimal increase in the afatinib gMean C max and AUC ( 4.1 and 18.6 % for simultaneous administration with AUC not completely within the bioequivalence limits ; 5.1 and 10.8 % for timed administration within the bioequivalence limits ) .
RESULTS	Administration of afatinib 40 mg in the presence of rifampicin led to reduction in C max and AUC by 21.6 and 33.8 % , respectively .
RESULTS	In all studies , P-gp modulation mainly affected the extent of absorption of afatinib ; there was no change in the terminal elimination half-life .
RESULTS	The overall safety profile of afatinib was acceptable .
CONCLUSIONS	Coadministration of potent P-gp modulators had no clinically relevant effect on afatinib exposure .
CONCLUSIONS	Effects of potent P-gp inhibitors were minimal at higher afatinib doses and can be readily managed by the timing of concomitant therapy .
CONCLUSIONS	As afatinib is not a relevant modulator or substrate of cytochrome P450 enzymes , the drug-drug interaction potential is considered to be low .

###25525519
BACKGROUND	Entonox ( N2O2 ) which is an inhalational gas for relieving labor pain is commonly used intermittently ; however some women are interested in continuous breathing in face mask .
BACKGROUND	So we decided to compare the complications induced by two methods to find out whether it is safe to permit the mothers to use Entonox continuously or not .
METHODS	This randomized clinical trial was performed in Mobini Hospital , Sabzevar , Iran .
METHODS	50 parturients used Entonox intermittently and 50 cases used it continuously during labor .
METHODS	Then obstetrical outcomes were analyzed in two groups by spss 17 software , t-test , and Chi ( 2 ) while P < 0.05 was considered significant .
RESULTS	This study showed the mean duration of second stage of labor had no significant difference ( P = 0.3 ) .
RESULTS	Perineal laceration was less in continuous group significantly ( P = 0.04 ) .
RESULTS	Assisted vaginal birth was not different significantly ( P = 0.4 ) .
RESULTS	Uterine atony had no significant difference in two groups ( P = 0.2 ) .
RESULTS	Maternal collaboration in pushing and satisfaction were higher in continuous group significantly ( P = 0.03 ) , ( P < 0.0001 ) .
RESULTS	Apgar score of neonates at first and fifth minute was acceptable and not different significantly in two groups ( P = 0.3 ) .
CONCLUSIONS	Our study demonstrated continuous method is also safe .
CONCLUSIONS	So , it seems reasonable to set mothers free to choose the desired method of Entonox usage .

###25820612
OBJECTIVE	Treatment nonadherence and relapse are common problems in patients with schizophrenia .
OBJECTIVE	The long-acting 3-month formulation of paliperidone palmitate , owing to its extended elimination half-life , may offer a valuable therapeutic option for these patients .
OBJECTIVE	To evaluate the efficacy and safety of the 3-month formulation of paliperidone palmitate vs placebo in delaying time to relapse of schizophrenia symptoms .
METHODS	This randomized , multicenter trial conducted from April 26 , 2012 , through April 9 , 2014 , in 8 countries consisted of 4 phases : 3-week screening phase , flexible-dose 17-week open-label transition phase , 12-week open-label maintenance phase , and open-ended double-blind ( DB ) phase .
METHODS	Of the 506 patients enrolled ( aged 18-70 years ; DSM-IV-TR diagnosis of schizophrenia ) , 305 were randomized to 3-month paliperidone palmitate ( n = 160 ) or placebo ( n = 145 ) in the DB phase .
METHODS	Patients received once-monthly doses of the 1-month formulation of paliperidone palmitate ( 50 , 75 , 100 , or 150 mg eq ) during the transition phase , followed by a single dose of the 3-month formulation ( 3.5 times the stabilized dose of once-monthly paliperidone palmitate ) during the maintenance phase .
METHODS	Stabilized patients were randomized to receive either a fixed dose of 3-month paliperidone palmitate ( 175 , 263 , 350 , or 525 mg eq ) or placebo once every 3 months during the DB phase .
METHODS	Time from randomization to the first relapse event ( time to relapse ) in the DB phase .
RESULTS	In the interim analysis , time to first relapse was significantly different in favor of the paliperidone palmitate group vs the placebo group ( hazard ratio = 3.45 ; 95 % CI , 1.73-6 .88 ; P < .001 ) ; median time to relapse was 274 days for placebo but not estimable for 3-month paliperidone palmitate .
RESULTS	An independent data monitoring committee recommended early study termination due to efficacy .
RESULTS	In the DB phase , 183 of 305 patients ( 62 % with 3-month paliperidone palmitate ; 58 % with placebo ) had at least 1 treatment-emergent adverse event ; those noted more frequently in the group receiving paliperidone palmitate than in the placebo group were headache ( 9 % vs 4 % ) , weight increased ( 9 % vs 3 % ) , nasopharyngitis ( 6 % vs 1 % ) , and akathisia ( 4 % vs 1 % ) .
CONCLUSIONS	Compared with placebo , the 3-month formulation of paliperidone palmitate administered 4 times yearly significantly delayed time to relapse in patients with schizophrenia .
CONCLUSIONS	The 3-month formulation was generally tolerable and has a safety profile consistent with other marketed paliperidone formulations .
BACKGROUND	clinicaltrials.gov Identifier : NCT01529515 .

###24591296
BACKGROUND	Functional endoscopic sinus surgery ( FESS ) has become the treatment of choice for patients with medically resistant chronic rhinosinusitis ( CRS ) and nasal polyps .
BACKGROUND	Despite the consolidated use of different treatments , the postoperative period is often very painful and uncomfortable , especially during the first month .
BACKGROUND	Although evidence on the effectiveness of sodium hyaluronate ( SH ) on postoperative care following FESS is available , data on the quality of life ( QoL ) from the patients ' perspective are still lacking .
BACKGROUND	This study aimed to evaluate for the first time the effectiveness of nasal douche with SH in reducing patients ' discomfort during the first month following FESS .
METHODS	A double-blind randomized controlled study was carried out on 124 subjects undergoing FESS for CRS with nasal polyposis .
METHODS	They were divided into 2 groups : group I was treated with nasal douche containing 9 mg of high molecular weight SH plus saline solution and group II was treated with saline solution alone .
METHODS	To assess QoL in CRS patients , the Short Form-36 ( SF-36 ) test , the Sino-Nasal Outcome Test-22 ( SNOT-22 ) , and the visual analogue scale ( VAS ) questionnaires were administered .
RESULTS	At baseline , there were no statistically significant differences between the 2 groups .
RESULTS	However , after 30 days of long postoperative treatments , we found clinically significant improvements in QoL of subjects treated with SH , as evidenced by all QoL scales .
CONCLUSIONS	Our data indicate that SH significantly improves patients ' short-term QoL following FESS in terms of both general health and specific sinonasal status .

###24580125
CONCLUSIONS	Kinetic oscillation stimulation ( KOS ) of nasal mucosa at low frequency seems to be a possibly effective and safe short-term treatment of non-allergic nasal stuffiness .
OBJECTIVE	To assess the relief of rhinitis symptoms , especially stuffiness , by comparing active treatment , i.e. KOS at low frequency of the nasal mucosa , with placebo .
METHODS	Patients were randomized to active or placebo treatment in this double-blinded parallel design study .
METHODS	Treatment with an inflatable oscillating catheter was administered on day 0 , and symptom scores ( stuffiness , secretion , and itching ) were graded daily until day 14 .
METHODS	An overall grading of symptoms from 1 week before treatment and during 14 days thereafter was made at day 14 .
METHODS	Eighty-six patients ( 52 with non-allergic perennial rhinitis , NAR ; 34 with rhinitis medicamentosa , RM ) were randomized , and 71 were evaluated ( active treatment , n = 35 ; placebo , n = 36 ) .
RESULTS	Patients with either NAR or RM who received active treatment reported reduced symptom scores by some measures , e.g. median RQSS stuffiness measure fell from 2 to 1 on a scale from 0 to 3 during the week following treatment .
RESULTS	No significant effect was observed for patients treated with placebo .
RESULTS	Mild side effects were reported .

###24231012
OBJECTIVE	The aim of study was to confirm the protective effects of parenteral glutamine supplementation on liver injury in premature infants and determine how quickly effects became evident .
METHODS	We performed a double-blind , randomized , controlled clinical study to assess the effect of parenteral nutrition ( PN ) supplemented with glutamine in premature infants .
METHODS	Thirty infants from two children 's centers , were randomly assigned to either a control group ( Standard PN ; n = 15 ) or a glutamine-supplemented group ( GlnPN ; n = 15 ) .
METHODS	The primary endpoint was hepatic function .
METHODS	The secondary endpoints were total duration of PN , weight and head circumference gain , length of hospitalization , and days on a ventilator .
RESULTS	The serum level of alkaline phosphatase ( AKP ) after parenteral nutrition for 14 days was significantly higher ( p < 0.05 ) in the control group .
RESULTS	But in the glutamine-supplemented group , the serum concentration of aspartate aminotransferase ( AST ) and gamma glutamyltransferase ( GGT ) significantly decreased after PN for 7 days and 14 days ( p < 0.05 ) , and the level of alkaline phosphatase ( AKP ) showed no increase .
RESULTS	The levels of AKP and GGT were significantly different with time by group interaction .
RESULTS	Levels of AKP was higher in control group than glutamine-supplemented group , and GGT level was lower in glutamine-supplemented group compared with controls .
RESULTS	There were no significant differences between the groups in terms of total duration of PN , weight gain ( g/d ) , increase in head circumference ( cm/w ) , length of hospitalization , and duration of mechanical ventilation .
CONCLUSIONS	The longer the duration of parenteral nutrition , the more severe hepatic dysfunction became .
CONCLUSIONS	Parenteral glutamine supplementation suggested a hepatoprotective effect .

###24935517
BACKGROUND	Midazolam and propofol used alone for long-term sedation are associated with adverse effects .
BACKGROUND	Sequential use may reduce the adverse effects , and lead to faster recovery , earlier extubation and lower costs .
BACKGROUND	This study evaluates the effects , safety , and cost of midazolam , propofol , and their sequential use for long-term sedation in critically ill mechanically ventilated patients .
METHODS	A total of 135 patients who required mechanical ventilation for > 3 days were randomly assigned to receive midazolam ( group M ) , propofol ( group P ) , or sequential use of both ( group M-P ) .
METHODS	In group M-P , midazolam was switched to propofol until the patients passed the spontaneous breathing trial ( SBT ) safety screen .
METHODS	The primary endpoints included recovery time , extubation time and mechanical ventilation time .
METHODS	The secondary endpoints were pharmaceutical cost , total cost of ICU stay , and recollection to mechanical ventilation-related events .
RESULTS	The incidence of agitation following cessation of sedation in group M-P was lower than group M ( 19.4 % versus 48.7 % , P = 0.01 ) .
RESULTS	The mean percentage of adequate sedation and duration of sedation were similar in the three groups .
RESULTS	The recovery time , extubation time and mechanical ventilation time of group M were 58.0 ( interquartile range ( IQR ) , 39.0 ) hours , 45.0 ( IQR , 24.5 ) hours , and 192.0 ( IQR , 124.0 ) hours , respectively ; these were significantly longer than the other groups , while they were similar between the other two groups .
RESULTS	In the treatment-received analysis , ICU duration was longer in group M than group M-P ( P = 0.016 ) .
RESULTS	Using an intention-to-treat analysis and a treatment-received analysis , respectively , the pharmaceutical cost of group M-P was lower than group P ( P < 0.01 ) and its ICU cost was lower than group M ( P < 0.01 ; P = 0.015 ) .
RESULTS	The proportion of group M-P with unbearable memory of the uncomfortable events was lower than in group M ( 11.7 % versus 25.0 % , P < 0.01 ) , while the proportion with no memory was similar ( P > 0.05 ) .
RESULTS	The incidence of hypotension in group M-P was lower than group ( P = 0.01 ) .
CONCLUSIONS	Sequential use of midazolam and propofol was a safe and effective sedation protocol , with higher clinical effectiveness and better cost-benefit ratio than midazolam or propofol used alone , for long-term sedation of critically ill mechanically ventilated patients .
BACKGROUND	Current Controlled Trials ISRCTN01173443 .
BACKGROUND	Registered 25 February 2014 .

###25366680
OBJECTIVE	We tested the efficacy and toxicity of cisplatin plus accelerated fractionation with a concomitant boost ( AFX-C ) versus standard fractionation ( SFX ) in locally advanced head and neck carcinoma ( LA-HNC ) .
METHODS	Patients had stage III to IV carcinoma of the oral cavity , oropharynx , hypopharynx , or larynx .
METHODS	Radiation therapy schedules were 70 Gy in 35 fractions over 7 weeks ( SFX ) or 72 Gy in 42 fractions over 6 weeks ( AFX-C ) .
METHODS	Cisplatin doses were 100 mg/m ( 2 ) once every 3 weeks for two ( AFX-C ) or three ( SFX ) cycles .
METHODS	Toxicities were scored by using National Cancer Institute Common Toxicity Criteria 2.0 and the Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer criteria .
METHODS	Overall survival ( OS ) and progression-free survival ( PFS ) rates were estimated by using the Kaplan-Meier method and were compared by using the one-sided log-rank test .
METHODS	Locoregional failure ( LRF ) and distant metastasis ( DM ) rates were estimated by using the cumulative incidence method and Gray 's test .
RESULTS	In all , 721 of 743 patients were analyzable ( 361 , SFX ; 360 , AFX-C ) .
RESULTS	At a median follow-up of 7.9 years ( range , 0.3 to 10.1 years ) for 355 surviving patients , no differences were observed in OS ( hazard ratio [ HR ] , 0.96 ; 95 % CI , 0.79 to 1.18 ; P = .37 ; 8-year survival , 48 % v 48 % ) , PFS ( HR , 1.02 ; 95 % CI , 0.84 to 1.24 ; P = .52 ; 8-year estimate , 42 % v 41 % ) , LRF ( HR , 1.08 ; 95 % CI , 0.84 to 1.38 ; P = .78 ; 8-year estimate , 37 % v 39 % ) , or DM ( HR , 0.83 ; 95 % CI , 0.56 to 1.24 ; P = .16 ; 8-year estimate , 15 % v 13 % ) .
RESULTS	For oropharyngeal cancer , p16-positive patients had better OS than p16-negative patients ( HR , 0.30 ; 95 % CI , 0.21 to 0.42 ; P < .001 ; 8-year survival , 70.9 % v 30.2 % ) .
RESULTS	There were no statistically significant differences in the grade 3 to 5 acute or late toxicities between the two arms and p-16 status .
CONCLUSIONS	When combined with cisplatin , AFX-C neither improved outcome nor increased late toxicity in patients with LA-HNC .
CONCLUSIONS	Long-term high survival rates in p16-positive patients with oropharyngeal cancer support the ongoing efforts to explore deintensification .

###25156687
OBJECTIVE	For stable angina , the benefits of percutaneous coronary intervention ( PCI ) are limited to symptom relief , but patients often believe that PCI prevents myocardial infarction ( MI ) .
OBJECTIVE	Whether presenting accurate information about the benefits of PCI would dispel these beliefs remains unknown .
OBJECTIVE	We hypothesized that explanatory information would be more effective for influencing volunteers ' beliefs .
OBJECTIVE	To assess the effect of explicit and explanatory information on participants ' beliefs about PCI and their willingness to choose it .
METHODS	We conducted a randomized trial in 2012 among adults older than 50 years living in the general community .
METHODS	We recruited participants using the Internet .
METHODS	Participants read 1 of 3 scenarios in which they experienced class I angina and were referred to a cardiologist .
METHODS	The cardiologist provided no information about the effects of PCI on MI risk , a specific statement that PCI does not reduce MI risk , or an explanation of why PCI does not reduce MI risk .
METHODS	Participants ' beliefs about the benefit of PCI and choice of PCI and medication .
RESULTS	A total of 1257 participants ( 90.0 % ) completed the survey ; 54.5 % chose PCI .
RESULTS	Compared with those receiving explicit and explanatory information , those receiving no information were most likely to believe that PCI prevents MI ( 71.0 % vs 38.7 % vs 30.6 % , respectively ; P < .001 ) , most likely to choose PCI ( 69.4 % vs 48.7 % vs 45.7 % , respectively ; P < .001 ) , and least likely to agree to medication therapy ( 83.1 % vs 87.4 % vs 92.3 % , respectively ; P < .001 ) .
RESULTS	Across the entire sample , the decision to have PCI was strongly correlated with the belief that PCI would prevent MI ( odds ratio , 5.82 [ 95 % CI , 4.13-8 .26 ] ) and that the participant would feel less worried ( odds ratio , 5.36 [ 95 % CI , 3.87-7 .45 ] ) , but was not associated with how much participants were limited by symptoms .
CONCLUSIONS	In the setting of mild , stable angina , most people assume PCI prevents MI and are likely to choose it .
CONCLUSIONS	Explicit information can partially overcome that bias and influence decision making .
CONCLUSIONS	Explanatory information was the most effective intervention in overcoming this bias .

###25879193
BACKGROUND	Smoking cessation interventions for hospitalized smokers are effective in promoting smoking cessation , but only if the tobacco dependence treatment continues after the patient leaves the hospital .
BACKGROUND	Sustaining tobacco dependence treatment after hospital discharge is a challenge for health care systems .
BACKGROUND	Our previous single-site randomized controlled trial demonstrated the effectiveness of an intervention that facilitated the delivery of comprehensive tobacco cessation treatment , including both medication and counseling , after hospital discharge .
BACKGROUND	We subsequently streamlined the intervention model to increase its potential for dissemination .
BACKGROUND	This new model is being tested in a larger multi-site trial with broader eligibility criteria in order to enroll a more representative sample of hospitalized smokers .
BACKGROUND	This paper describes the trial design and contrasts it with the earlier study .
METHODS	A 2-arm , 3-site randomized controlled trial is testing the hypothesis that a multi-component Sustained Care intervention is more effective than Standard Care in helping hospitalized cigarette smokers stop smoking after hospital discharge .
METHODS	The trial enrolls adult daily cigarette smokers who are admitted to 1 of 3 participating hospitals in Massachusetts or Pennsylvania .
METHODS	Participants receive the same smoking cessation intervention in the hospital .
METHODS	They are randomly assigned to receive either Standard Care or Sustained Care after hospital discharge .
METHODS	Participants in the Sustained Care arm receive a free 3-month supply of FDA-approved smoking cessation medication and 5 interactive voice response calls that provide tailored motivational messages , medication refills , and access to a live tobacco treatment counselor .
METHODS	Participants in the Standard Care arm receive a smoking cessation medication recommendation and information about community resources .
METHODS	Outcomes are assessed at 1 , 3 , and 6 months after discharge .
METHODS	The primary outcome is biochemically-validated tobacco abstinence for the past 7 days at 6-month follow-up .
METHODS	Other outcome measures include self-reported tobacco abstinence measures , use of medication and counseling after discharge , hospital readmissions , and program cost-effectiveness .
CONCLUSIONS	We adapted a proven intervention for hospitalized smokers to enhance its potential for dissemination and are testing it in a multi-site trial .
CONCLUSIONS	Study enrollment data suggests that the trial achieved the goal of recruiting a broader sample of hospitalized smokers .
BACKGROUND	Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers ( Helping HAND2 ) NCT01714323 .
BACKGROUND	Registered October 22 , 2012 .

###24452727
BACKGROUND	The relationships between Q waves that appear during the acute phase of ST-elevation myocardial infarction ( STEMI ) , clinical characteristics , ST-segment resolution ( STRes ) , and clopidogrel therapy in patients treated with fibrinolysis are not well described .
OBJECTIVE	We hypothesized that Q waves would be associated with less successful reperfusion and increased cardiovascular events .
METHODS	In the CLARITY-TIMI 28 trial , 3491 STEMI patients treated with fibrinolysis were randomized to clopidogrel or placebo .
METHODS	Electrocardiograms were evaluated for STRes post-fibrinolysis and the presence of pathologic Q waves during the index hospitalization in 3322 patients .
RESULTS	Q waves were identified in 2045 patients ( 61.6 % ) prior to discharge and were associated with increased odds of congestive heart failure ( CHF ) ( adjusted odds ratio [ ORadj ] : 2.10 , P = 0.002 ) or the composite of cardiovascular death/CHF at 30days ( ORadj : 2.08 , P 0.001 ) .
RESULTS	Q waves were associated with lower odds of Thrombolysis in Myocardial Infarction [ TIMI ] flow grade 2 to 3 ( ORadj : 0.78 , P = 0.028 ) , TIMI myocardial perfusion grade 3 ( ORadj : 0.83 , P = 0.029 ) , and complete STRes at 90minutes ( ORadj : 0.80 , P = 0.030 ) .
RESULTS	Patients with both a Q wave and incomplete STRes 90minutes after fibrinolysis were at higher risk for cardiovascular death or CHF ( 11.1 % ) than patients with no Q wave and at least partial STRes ( 1.9 % ) .
RESULTS	Overall , clopidogrel tended to be equally or more effective in patients without Q waves compared to those with Q waves .
CONCLUSIONS	Among STEMI patients treated with fibrinolysis , evaluating for Q waves prior to discharge is a simple method of assessing for less successful reperfusion and an increased risk of adverse 30-day cardiovascular outcomes .
CONCLUSIONS	The combination of Q waves and 90-minute STRes allows additional risk refinement .

###25683204
BACKGROUND	Risk-stratified screening for prostate cancer ( PCa ) with prostate-specific antigen ( PSA ) testing incorporating genetic variants has received some attention but has been scarcely investigated .
BACKGROUND	We developed a model to stratify the Finnish population by different risk profiles related to genetic variants to optimize the screening policy .
METHODS	Data from the Finnish randomized controlled trial on screening for PCa with PSA testing were used to estimate a six-state Markov model of disease progression .
METHODS	Blood samples from Finnish men were used to assess the risk of PCa related to three genetic variants ( rs4242382 , rs138213197 , and rs200331695 ) .
METHODS	A risk score-based approach combined with a series of computer simulation models was applied to optimize individual screening policies .
RESULTS	The 10-year risk of having progressive prostate cancer detected ranged from 43 % in the top 5 % risk group to approximately 11 % in the bottom half of the population .
RESULTS	Using the median group , with screening every four years beginning at 55 years-old , as the reference group , the recommended age beginning screening was approximately 47 years-old for the top 5 % risk group and 55 years-old for those in the lower 60 % risk group .
RESULTS	The recommended interscreening interval has been shortened for individuals in the high risk group .
RESULTS	The increased availability of genomic information allows the proposed multistate model to be more discriminating with respect to risk stratification and the suggested screening policy , particularly for the lowest risk groups - .
RESULTS	--
CONCLUSIONS	A multi-state genetic variant-based model was developed for further application to population risk stratification to optimize the interscreening interval and the age at which to begin screening for PSA .
CONCLUSIONS	A small sub-group of the population is likely to benefit from more intensive screening with early start and short interval , while half of the population is unlikely to benefit from such protocol ( compared with four-year interval after age 55 years ) .

###25953073
OBJECTIVE	There are a limited number of marketed intravenous antiepileptic drugs ( AEDs ) available to treat status epilepticus ( SE ) .
OBJECTIVE	All were first developed for chronic therapy of epilepsy , not specifically for SE .
OBJECTIVE	Epilepsy and canine SE ( CSE ) occur naturally in dogs , with prevalence , presentation , and percentage of refractory cases similar to human epilepsy .
OBJECTIVE	The objective of this study was to determine if CSE treated with fosphenytoin ( FOS ) results in a similar responder rate as for people .
METHODS	A randomized clinical trial was performed for dogs with CSE .
METHODS	Dogs who presented during a seizure or who had additional seizures after enrolling received intravenous ( i.v. ) benzodiazepine ( BZD ) followed immediately by intravenous infusion of 15 mg/kg phenytoin equivalent ( PE ) of fosphenytoin ( FOS ) or saline placebo ( PBO ) .
METHODS	If seizures continued , additional AEDs were administered per the standard of care for veterinary patients .
METHODS	Total and unbound plasma phenytoin ( PHT ) concentrations were measured .
RESULTS	Consent was obtained for 50 dogs with CSE .
RESULTS	Thirty-one had additional motor seizures and were randomized to the study intervention ( 22 FOS and 9 PBO ) .
RESULTS	There was a statistically significant difference in the 12 h responder rate , with 63 % in the FOS group versus 22 % in the placebo group ( p = 0.043 ) having no further seizures .
RESULTS	The unbound PHT concentrations at 30 and 60 min were within the therapeutic concentrations for people ( 1-2 g/ml ) with the exception of one dog .
RESULTS	There was mild vomiting in 36 % of the FOS group ( 7/22 ) within 20 min of FOS administration and none of the placebo group ( 0/9 ) ( p = 0.064 ) .
CONCLUSIONS	This proof of concept study provides the first evidence that FOS is tolerated and effective in canine SE at PHT concentrations clinically relevant for human SE .
CONCLUSIONS	Furthermore , naturally occurring CSE can be utilized as a translational platform for future studies of novel SE compounds .

###25133794
OBJECTIVE	Fenofibrate reduced progression of diabetic retinopathy in two large randomized studies .
OBJECTIVE	The effect of 135mg fenofibric acid on diabetic macular edema ( DME ) was evaluated in subjects with existing DME .
METHODS	In this double-blind , randomized , placebo-controlled study , 110 subjects with DME not requiring immediate photocoagulation or intraocular treatment with adequate diabetes and blood pressure control received either fenofibric acid or placebo once daily for 1 year .
METHODS	Total macula volume ( TMV ) and thickness were measured in the worse eye and all eligible eyes with time-domain optical coherence tomography at baseline and quarterly thereafter .
RESULTS	TMV decreased by -0.35 mm ( 3 ) ( within-group difference ) after fenofibric acid treatment and by -0.11 mm ( 3 ) after placebo .
RESULTS	The between-group comparison of the change was -0.25 mm ( 3 ) ( 95 % confidence interval , CI , -0.645 -0.155 ; p = 0.227 , worse eye analysis ) .
RESULTS	Weighted inner zone thickness and volume decreased by -18.7 m and -0.13 mm ( 3 ) , respectively , for within group difference after fenofibric acid and by -3.1 m and -0.02 mm ( 3 ) , respectively , after placebo .
RESULTS	Considering all eligible eyes , thicknesses at central zone , mean inner zone , and entire retina decreased by -21.3 m , -19.8 m , and -20.4 m , respectively , after fenofibric acid .
RESULTS	No between-group difference in changes of these measurements was observed .
RESULTS	Triglycerides decreased by 23 % after fenofibric acid ( vs 4 % after placebo , p = 0.001 ) and high-density lipoprotein cholesterol increased by 8 % ( vs 0.3 % , p = 0.014 ) .
RESULTS	No safety concern was identified .
CONCLUSIONS	Subjects treated with fenofibric acid had a modest improvement in TMV , although the study was probably underpowered to detect a benefit over placebo after 1 year .

###24919077
OBJECTIVE	The aim of this study was to determine whether transcranial direct current stimulation ( tDCS ) applied to the primary motor hand area modulates hand dexterity and selective attention after stroke .
METHODS	This study was a double-blind , placebo-controlled , randomized crossover trial involving subjects with chronic stroke .
METHODS	Ten stroke survivors with some pinch strength in the paretic hand received three different tDCS interventions assigned in random order in separate sessions-anodal tDCS targeting the primary motor area of the lesioned hemisphere ( M1lesioned ) , cathodal tDCS applied to the contralateral hemisphere ( M1nonlesioned ) , and sham tDCS-each for 20 mins .
METHODS	The primary outcome measures were Purdue pegboard test scores for hand dexterity and response time in the color-word Stroop test for selective attention .
METHODS	Pinch strength of the paretic hand was the secondary outcome .
RESULTS	Cathodal tDCS to M1nonlesioned significantly improved affected hand dexterity ( by 1.1 points on the Purdue pegboard unimanual test , P = 0.014 ) and selective attention ( 0.6 secs faster response time on the level 3 Stroop interference test for response inhibition , P = 0.017 ) , but not pinch strength .
RESULTS	The outcomes were not improved with anodal tDCS to M1lesioned or sham tDCS .
CONCLUSIONS	Twenty minutes of cathodal tDCS to M1nonlesioned can promote both paretic hand dexterity and selective attention in people with chronic stroke .

###25385260
OBJECTIVE	To assess the efficacy and safety of oral decernotinib ( VX-509 ; Vertex Pharmaceuticals ) monotherapy in a 12-week , randomized , double-blind , placebo-controlled , dose-ranging study of patients with rheumatoid arthritis ( RA ) .
METHODS	Two hundred four adults with active RA who had been unsuccessfully treated with 1 disease-modifying antirheumatic drug were administered placebo tablets or decernotinib twice a day at dosages of 25 mg , 50 mg , 100 mg , or 150 mg .
METHODS	Primary measures of efficacy at week 12 were the response rate according to the American College of Rheumatology 20 % improvement criteria ( ACR20 ) and mean change from baseline in the Disease Activity Score in 28 joints using the C-reactive protein level ( DAS28-CRP ) .
RESULTS	At week 12 , the ACR20 response rates were 39.0 % , 61.0 % , 65.0 % , and 65.9 % in the 25-mg , 50-mg , 100-mg , and 150-mg groups , respectively , and were significantly higher in the 50-mg group ( P = 0.007 ) and the 100-mg and 150-mg groups ( P = 0.002 ) as compared to the response rates in the placebo group ( 29.3 % ) .
RESULTS	The mean change from baseline in DAS28-CRP was greater in the 50-mg , 100-mg , and 150-mg groups as compared to the placebo group ( P < 0.001 ) .
RESULTS	Decernotinib treatment resulted in higher ACR50 and ACR70 response rates , more patients with DAS28-CRP scores < 2.6 , and improvements in the Health Assessment Questionnaire disability index as compared to placebo .
RESULTS	The most common adverse events in any decernotinib group were nausea ( 6.1 % ) , headache ( 4.3 % ) , an increase in levels of alanine aminotransferase ( 4.3 % ) , and hypercholesterolemia ( 3.7 % ) .
RESULTS	In the groups receiving decernotinib , there was an increased risk of infections and increased liver transaminase levels .
CONCLUSIONS	Decernotinib was efficacious in improving clinical signs and symptoms of RA at week 12 at dosages of 50-150 mg twice a day .
CONCLUSIONS	Infections and increases in liver transaminase and lipid levels were noted as potential safety signals .

###25304296
BACKGROUND	The main goal of this randomized controlled single-blinded pilot study was to study whether , independent of weight loss , a Palaeolithic-type diet alters characteristics of the metabolic syndrome .
BACKGROUND	Next we searched for outcome variables that might become favourably influenced by a Paleolithic-type diet and may provide new insights in the pathophysiological mechanisms underlying the metabolic syndrome .
BACKGROUND	In addition , more information on feasibility and designing an innovative dietary research program on the basis of a Palaeolithic-type diet was obtained .
METHODS	Thirty-four subjects , with at least two characteristics of the metabolic syndrome , were randomized to a two weeks Palaeolithic-type diet ( n = 18 ) or an isoenergetic healthy reference diet , based on the guidelines of the Dutch Health Council ( n = 14 ) .
METHODS	Thirty-two subjects completed the study .
METHODS	Measures were taken to keep bodyweight stable .
METHODS	As primary outcomes oral glucose tolerance and characteristics of the metabolic syndrome ( abdominal circumference , blood pressure , glucose , lipids ) were measured .
METHODS	Secondary outcomes were intestinal permeability , inflammation and salivary cortisol .
METHODS	Data were collected at baseline and after the intervention .
RESULTS	Subjects were 53.5 ( SD9 .7 ) year old men ( n = 9 ) and women ( n = 25 ) with mean BMI of 31.8 ( SD5 .7 ) kg/m2 .
RESULTS	The Palaeolithic-type diet resulted in lower systolic blood pressure ( -9.1 mmHg ; P = 0.015 ) , diastolic blood pressure ( -5.2 mmHg ; P = 0.038 ) , total cholesterol ( -0.52 mmol/l ; P = 0.037 ) , triglycerides ( -0.89 mmol/l ; P = 0.001 ) and higher HDL-cholesterol ( +0.15 mmol/l ; P = 0.013 ) , compared to reference .
RESULTS	The number of characteristics of the metabolic syndrome decreased with 1.07 ( P = 0.010 ) upon the Palaeolithic-type diet , compared to reference .
RESULTS	Despite efforts to keep bodyweight stable , it decreased in the Palaeolithic group compared to reference ( -1.32 kg ; P = 0.012 ) .
RESULTS	However , favourable effects remained after post-hoc adjustments for this unintended weight loss .
RESULTS	No changes were observed for intestinal permeability , inflammation and salivary cortisol .
CONCLUSIONS	We conclude that consuming a Palaeolithic-type diet for two weeks improved several cardiovascular risk factors compared to a healthy reference diet in subjects with the metabolic syndrome .
BACKGROUND	Nederlands Trial Register NTR3002 .

###26241419
OBJECTIVE	To evaluate whether the addition of glyburide to diet therapy modifies pregnancy outcomes in women with mild gestational diabetes .
METHODS	Women with at least two abnormal values on a 3-hour , 100-g oral glucose tolerance test according to National Diabetes Data Group criteria and fasting values less than 105 mg/dL between 24 and 30 weeks of gestation were randomized to blinded glyburide or placebo study drug .
METHODS	All women were placed on a 35-kcal/kg diet and recorded four times daily capillary glucose measurements .
METHODS	The study drug was titrated based on weekly maternal capillary glucose values with targets of less than 95 mg/dL ( 5.3 mmol/L ) and 120 mg/dL ( 6.7 mmol/L ) for fasting and 2-hour postprandial glucose measurements , respectively .
METHODS	The primary study outcome was a 200-g birth weight decrement in neonates of women treated with glyburide .
METHODS	The sample size estimate for this outcome was 334 total randomized women with a one-to-one allocation .
RESULTS	A total of 395 women were enrolled at a single center between September 2008 and October 2012 .
RESULTS	Women treated with glyburide had a significantly greater decline in fasting glucose values over the course of therapy .
RESULTS	However , there was no difference in the primary study outcome .
RESULTS	Specifically , the mean birth weight was 33 g lower in the group treated with glyburide ( P = .52 ) .
RESULTS	Although not powered to examine all outcomes associated with gestational diabetes , treatment with glyburide did not affect need for operative delivery , shoulder dystocia , clavicular fracture , Erb 's palsy , or neonatal hypoglycemia .
RESULTS	Four women in each group required insulin .
CONCLUSIONS	The addition of glyburide to diet therapy significantly improved maternal glycemic control over time when compared with placebo .
CONCLUSIONS	However , adding glyburide to diet did not decrease birth weight or improve maternal or neonatal outcomes in women with mild gestational diabetes .
BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT00744965 .
METHODS	I.

###24319685
BACKGROUND	Innovative cardiopulmonary bypass ( CPB ) settings have been developed in order to integrate the concepts of `` surface-coating , '' `` blood-filtration , '' and `` miniaturization . ''
OBJECTIVE	To compare integrated and nonintegrated arterial line filters in terms of peri - and postoperative clinical variables , inflammatory response , and transfusion needs .
METHODS	Thirty-six patients who underwent coronary bypass surgery were randomized into integrated ( Group In ) and nonintegrated arterial line filter ( Group NIn ) groups .
METHODS	Arterial blood samples for the assessments of complete hemogram , biochemical screening , interleukin-6 , interleukin-2R , and C-reactive protein were analyzed before and after surgery .
METHODS	Need for postoperative dialysis , inotropic therapy and transfusion , in addition to extubation time , total amount of drainage ( mL ) , length of intensive care unit , and hospital stay , and mortality rates was also recorded for each patient .
RESULTS	Prime volume was significantly higher and mean intraoperative hematocrit value was lower in Group NIn , but need for erythrocyte transfusion was significantly higher in Group NIn .
RESULTS	C-reactive protein values did not differ significantly except for postoperative second day 's results , which were found significantly lower in Group In than in Group NIn .
CONCLUSIONS	Intraoperative hematocrit levels were higher and need for postoperative erythrocyte transfusion was decreased in Group In .

###24690201
BACKGROUND	Low back pain ( LBP ) is a prevalent condition and a socioeconomic problem in many countries .
BACKGROUND	Due to its recurrent nature , the prevention of further episodes ( secondary prevention ) , seems logical .
BACKGROUND	Furthermore , when the condition is persistent , the minimization of symptoms and prevention of deterioration ( tertiary prevention ) , is equally important .
BACKGROUND	Research has largely focused on treatment methods for symptomatic episodes , and little is known about preventive treatment strategies .
METHODS	This study protocol describes a randomized controlled clinical trial in a multicenter setting investigating the effect and cost-effectiveness of preventive manual care ( chiropractic maintenance care ) in a population of patients with recurrent or persistent LBP.Four hundred consecutive study subjects with recurrent or persistent LBP will be recruited from chiropractic clinics in Sweden .
METHODS	The primary outcome is the number of days with bothersome pain over 12 months .
METHODS	Secondary measures are self-rated health ( EQ-5D ) , function ( the Roland Morris Disability Questionnaire ) , psychological profile ( the Multidimensional Pain Inventory ) , pain intensity ( the Numeric Rating Scale ) , and work absence.The primary utility measure of the study is quality-adjusted life years and will be calculated using the EQ-5D questionnaire .
METHODS	Direct medical costs as well as indirect costs will be considered.Subjects are randomly allocated into two treatment arms : 1 ) Symptom-guided treatment ( patient controlled ) , receiving care when patients feel a need .
METHODS	2 ) Preventive treatment ( clinician controlled ) , receiving care on a regular basis .
METHODS	Eligibility screening takes place in two phases : first , when assessing the primary inclusion/exclusion criteria , and then to only include fast responders , i.e. , subjects who respond well to initial treatment .
METHODS	Data are collected at baseline and at follow-up as well as weekly , using SMS text messages .
CONCLUSIONS	This study investigates a manual strategy ( chiropractic maintenance care ) for recurrent and persistent LBP and aims to answer questions regarding the effect and cost-effectiveness of this preventive approach .
CONCLUSIONS	Strict inclusion criteria should ensure a suitable target group and the use of frequent data collection should provide an accurate outcome measurement .
CONCLUSIONS	The study utilizes normal clinical procedures , which should aid the transferability of the results .
BACKGROUND	Clinical trials.gov ; NCT01539863 , February 22 , 2012 .
BACKGROUND	The first patient was randomized into the study on April 13th 2012 .

###24554302
OBJECTIVE	This multicentre , randomised , non-blinded , parallel group study is designed to assess the null hypothesis that a 3-month prophylactic schedule with fosfomycin is not inferior to prulifloxacin in reducing the number of urinary tract infection episodes during and after prophylaxis in female patients with recurrent urinary tract infections ( rUTIs ) .
METHODS	One hundred and fifty-two patients with rUTIs who were candidates for prophylaxis therapy were enrolled and randomised to prulifloxacin ( group 1 ) or fosfomycin ( group 2 ) .
METHODS	The prophylaxis regimen included a single dose of fosfomycin ( one 3-g cachet ) per week , or a single dose ( 600mg ) of prulifloxacin ( one tablet ) a week for 12 weeks .
METHODS	The inclusion criteria were female patients over 18 years , urine culture responsiveness to drugs at patient recruitment and history of rUTI .
METHODS	Exclusion criteria were pregnancy and counter-indications to this drug therapy .
METHODS	Patients were prospectively randomised .
METHODS	Check-ups were scheduled at 2 weeks , 1 month and 3 months from the beginning of the study and 3 , 6 , and 12 months after suspension of the therapy .
METHODS	The primary end-points were the reduction of the number of UTIs ( negative urine culture ) during and after prophylaxis .
RESULTS	Final data analysis included 67 patients in group 1 and 57 in group 2 .
RESULTS	Nine out of 76 patients ( group 1 ) and 19 out of 76 ( group 2 ) dropped out .
RESULTS	UTI episodes were significantly reduced in number compared with before prophylaxis ( p < 0.0001 ) at all study end-points in both groups .
RESULTS	No significant differences were found in disease-free duration , as achieved by the two therapy groups ( log-rank test ; p = 0.41 ) , in the reduction of UTI episodes during and after prophylaxis , in the adverse effects or improved quality of life .
CONCLUSIONS	Both drugs provided adequate prophylaxis in patients with rUTIs , with no difference in efficacy .

###24529603
OBJECTIVE	Psychological interventions are used in patients with inflammatory bowel disease ( IBD ) but there is uncertainty about who the optimal target population is .
OBJECTIVE	Multi-convergent therapy ( MCT ) is a form of psychotherapy that combines mindfulness meditation with aspects of cognitive behavioural therapy and has been used in the management of irritable bowel syndrome ( IBS ) .
OBJECTIVE	This study aimed to assess the feasibility and efficacy of MCT in the management of IBD patients with either functional abdominal symptoms or high perceived stress levels .
METHODS	Sixty-six IBD patients in clinical remission with either IBS-type symptoms or high perceived stress levels were randomly allocated to a 16-week MCT course or waiting list control group .
METHODS	Patients were followed-up for one year with the Inflammatory Bowel Disease Questionnaire ( IBDQ ) as the primary outcome measurement .
RESULTS	A higher mean IBDQ score was observed in the active group compared to controls at the 4-month assessment ( 167 vs. 156 , p = 0.081 ) , but this was not statistically significant nor did it reached the predefined clinically significant difference of 20 .
RESULTS	In patients with IBS-type symptoms at baseline there was a significantly higher mean IBDQ score in the active group compared to controls ( 161 vs. 145 , p = 0.021 ) .
RESULTS	There was no difference between groups in relapse rate based on faecal calprotectin measurement .
CONCLUSIONS	IBS-type symptoms in patients with IBD represent a potential therapeutic target to improve quality of life .
CONCLUSIONS	This study suggests that MCT may be useful in the management of these symptoms but larger studies are required to confirm this .
BACKGROUND	NCT01426568 .

###24561148
OBJECTIVE	This study sought to report the treatment effect of ticagrelor on myocardial infarction ( MI ) and the strategy for and impact of event adjudication in the PLATO ( Platelet Inhibition and Patient Outcomes ) trial .
BACKGROUND	In PLATO , ticagrelor reduced cardiovascular death , MI , or stroke in patients with acute coronary syndromes ( ACS ) .
METHODS	A clinical events committee ( CEC ) prospectively defined and adjudicated all suspected MI events , on the basis of events reported by investigators and by triggers on biomarkers .
METHODS	Treatment comparisons used CEC-adjudicated data , and per protocol , excluded silent MI .
RESULTS	Overall , 1,299 ( 610 ticagrelor , 689 clopidogrel ) MIs reported by the CEC occurred during the trial .
RESULTS	Of these , 1,097 ( 504 ticagrelor , 593 clopidogrel ) contributed to the primary composite endpoint .
RESULTS	Site investigators reported 1,198 ( 580 ticagrelor , 618 clopidogrel ) MIs .
RESULTS	Ticagrelor significantly reduced overall MI rates ( 12-month CEC-adjudicated Kaplan-Meier rates : 5.8 % ticagrelor , 6.9 % clopidogrel ; hazard ratio [ HR ] : 0.84 ; 95 % confidence interval [ CI ] : 0.75 to 0.95 ) .
RESULTS	Nonprocedural MI ( HR : 0.86 ; 95 % CI : 0.74 to 1.01 ) and MI related to percutaneous coronary intervention or stent thrombosis tended to be lower with ticagrelor .
RESULTS	MIs related to coronary artery bypass graft surgery were few , but numerical excess was observed in patients assigned ticagrelor .
RESULTS	Analyses of overall MIs using investigator-reported data showed similar results but did not reach statistical significance ( HR : 0.88 ; 95 % CI : 0.78 to 1.00 ) .
CONCLUSIONS	In patients with ACS , ticagrelor significantly reduced the incidence of MI compared with clopidogrel , with consistent results across most MI subtypes .
CONCLUSIONS	CEC procedures identified more MI endpoints compared with site investigators .
CONCLUSIONS	( A Comparison of Ticagrelor [ AZD6140 ] and Clopidogrel in Patients With Acute Coronary Syndrome [ PLATO ] ; NCT00391872 ) .

###25972532
BACKGROUND	Improving diet and lifestyle is important for prevention of cardiovascular disease ( CVD ) .
BACKGROUND	Observational evidence suggests that increasing fruit and vegetable ( FV ) consumption may lower CVD risk , largely through modulation of established risk factors , but intervention data are required to fully elucidate the mechanisms by which FVs exert benefits on vascular health .
OBJECTIVE	The aim of this study was to examine the dose-response effect of FV intake on cardiovascular risk factors in adults at high CVD risk .
METHODS	This was a randomized controlled parallel group study involving overweight adults ( BMI : > 27 and 35 kg/m ( 2 ) ) with a habitually low FV intake ( 160 g/d ) and a high total risk of developing CVD ( estimated 20 % over 10 y ) .
METHODS	After a 4-wk run-in period where FV intake was limited to < 2 portions/d ( < 160 g/d ) , 92 eligible participants were randomly assigned to 1 of 3 groups : to consume either 2 , 4 , or 7 portions ( equivalent to 160 g , 320 g , or 560 g , respectively ) of FVs daily for 12 consecutive weeks .
METHODS	Fasting venous blood samples were collected at baseline ( week 4 ) and post-intervention ( week 16 ) for analysis of lipid fractions and high-sensitivity C-reactive protein ( hsCRP ) concentrations .
METHODS	Compliance with the FV intervention was determined with use of self-reported FV intake and biomarkers of micronutrient status .
METHODS	Ambulatory blood pressure and body composition were also measured pre - and post-intervention .
RESULTS	A total of 89 participants completed the study and body composition remained stable throughout the intervention period .
RESULTS	Despite good compliance with the intervention , no significant difference was found between the FV groups for change in measures of ambulatory blood pressure , plasma lipids , or hsCRP concentrations .
CONCLUSIONS	There was no evidence of a dose-response effect of FV intake on conventional CVD risk factors measured in overweight adults at high CVD risk .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT00874341 .

###24982002
OBJECTIVE	To compare the effect of a balance and stability-focused outpatient community-based rehabilitation and a regular physiotherapy program on balance , stability , and perceptions of improvement after acute stroke .
METHODS	A randomized controlled trial in a community-based therapy center .
METHODS	Fifty consecutive patients with a first stroke , who reported to a community-based therapy center over a 7-month period were allocated to the control group ( regular physiotherapy ) or the experimental group ( balance and stability-focused rehabilitation ) .
METHODS	A program of physiotherapy focused on balance and stability exercises .
METHODS	The control group received the regular physiotherapy program .
METHODS	The Postural Assessment Scale for Stroke Patients ( PASS ) and the Berg Balance Scale ( BBS ) monitored stability and balance .
METHODS	The normalized data ( PASS and BBS ) were analyzed by using analysis of covariance .
METHODS	Qualitative data were thematically described .
RESULTS	Internal consistency of baseline PASS and BBS scores was high ( Cronbach , .964 and .974 , respectively ) .
RESULTS	PASS overall pretest scores increased from 21.96 21.41 ( mean standard deviation ) and 21.52 8.43 to 67.67 28.42 and 80.16 22.60 posttest in the control and experimental groups , respectively .
RESULTS	Posttest scores were significantly different ( P = .004 ) .
RESULTS	The effect size was medium ( .490 ) .
RESULTS	The overall BBS scores showed overall mean ( standard deviation ) increases from 44.71 22.24 and 43.43 17.11 pretest to 48.71 23.18 and 59.71 18.20 posttest for the control and experimental groups , respectively .
RESULTS	The effect size was considered medium ( .532 ) .
CONCLUSIONS	The balance and stability-focused community-based rehabilitation program was more effective in improving stability and balance in patients with stroke compared with the regular physiotherapy program in resource-poor settings .

###25670539
OBJECTIVE	A phase 3 trial assessing response-based therapy in intermediate-risk Hodgkin lymphoma mandated real-time central review of involved field radiation therapy ( IFRT ) and imaging records by a centralized review center to maximize protocol compliance .
OBJECTIVE	We report the impact of centralized radiation therapy review on protocol compliance .
METHODS	Review of simulation films , port films , and dosimetry records was required before and after treatment .
METHODS	Records were reviewed by study-affiliated or review center-affiliated radiation oncologists .
METHODS	A deviation of 6 % to 10 % from protocol-specified dose was scored as `` minor '' ; a deviation of > 10 % was `` major . ''
METHODS	A volume deviation was scored as `` minor '' if margins were less than specified or `` major '' if fields transected disease-bearing areas .
METHODS	Interventional review and final compliance review scores were assigned to each radiation therapy case and compared .
RESULTS	Of 1712 patients enrolled , 1173 underwent IFRT at 256 institutions in 7 countries .
RESULTS	An interventional review was performed in 88 % of patients and a final review in 98 % .
RESULTS	Overall , minor and major deviations were found in 12 % and 6 % of patients , respectively .
RESULTS	Among the cases for which 1 pre-IFRT modification was requested by the Quality Assurance Review Center and subsequently made by the treating institution , 100 % were made compliant on final review .
RESULTS	By contrast , among the cases for which 1 modification was requested but not made by the treating institution , 10 % were deemed compliant on final review .
CONCLUSIONS	In a large trial with complex treatment pathways and heterogeneous radiation therapy fields , central review was performed in a large percentage of cases before IFRT and identified frequent potential deviations in a timely manner .
CONCLUSIONS	When suggested modifications were performed by the institutions , deviations were almost eliminated .

###24993817
OBJECTIVE	Prescription of inhaled corticosteroids to children with asthma is recommended at half the nominal dose of adults in order to reduce the risk of systemic side effects .
OBJECTIVE	However , there is a lack of pharmacokinetic trials supporting such dose reduction regimens .
OBJECTIVE	Therefore , we aimed to compare the systemic exposure to the active ingredients of a fixed dose combination of beclometasone-dipropionate ( BDP ) and formoterol after dry powder inhaler ( DPI ) administration in children , adolescents and adults .
METHODS	The pharmacokinetic profiles of formoterol and beclometasone-17-monopropionate ( B17MP ; active metabolite of BDP ) were evaluated over 8 h from two independent studies comprising children ( 6-11yrs , n = 27 ) , adolescents ( 12-17 yrs , n = 28 ) and adults ( 18 yrs , n = 30 ) receiving a single , fixed dose of BDP/formoterol ( children : 200 g/24 g , adolescents and adults : 400 g/24 g ) via DPI .
RESULTS	The systemic exposure ( AUC ) for children versus adults was almost doubled for formoterol and similar for B17MP despite the halved BDP dose administered in children .
RESULTS	In adolescents the AUC for formoterol and B17MP were approximately one third higher than in adults for both compounds .
RESULTS	Upon normalization for the BDP/formoterol dose in the three populations the AUC and peak concentration ( C ( max ) ) correlated inversely with age and body surface area of the patients ( r -0.53 ; p < 0.0001 ) .
CONCLUSIONS	The systemic exposure to the active ingredients of BDP/formoterol administered as DPI correlates inversely with age and body size suggesting that dry powder dosage regimens should be adjusted for age and body size to avoid high systemic drug levels in children .

###25480130
BACKGROUND	Pathogenic bacteria are often asymptomatically carried in the nasopharynx .
BACKGROUND	Bacterial carriage can be reduced by vaccination and has been used as an alternative endpoint to clinical disease in randomised controlled trials ( RCTs ) .
BACKGROUND	Vaccine efficacy ( VE ) is usually calculated as 1 minus a measure of effect .
BACKGROUND	Estimates of vaccine efficacy from cross-sectional carriage data collected in RCTs are usually based on prevalence odds ratios ( PORs ) and prevalence ratios ( PRs ) , but it is unclear when these should be measured .
METHODS	We developed dynamic compartmental transmission models simulating RCTs of a vaccine against a carried pathogen to investigate how VE can best be estimated from cross-sectional carriage data , at which time carriage should optimally be assessed , and to which factors this timing is most sensitive .
METHODS	In the models , vaccine could change carriage acquisition and clearance rates ( leaky vaccine ) ; values for these effects were explicitly defined ( f ( acq ) , 1/f ( dur ) ) .
METHODS	POR and PR were calculated from model outputs .
METHODS	Models differed in infection source : other participants or external sources unaffected by the trial .
METHODS	Simulations using multiple vaccine doses were compared to empirical data .
RESULTS	The combined VE against acquisition and duration calculated using POR ( VE ( acq.dur ) , ( 1-POR ) 100 ) best estimates the true VE ( VE ( acq.dur ) , ( 1-f ( acq ) f ( dur ) ) 100 ) for leaky vaccines in most scenarios .
RESULTS	The mean duration of carriage was the most important factor determining the time until VE ( acq.dur ) first approximates VE ( acq.dur ) : if the mean duration of carriage is 1-1 .5 months , up to 4 months are needed ; if the mean duration is 2-3 months , up to 8 months are needed .
RESULTS	Minor differences were seen between models with different infection sources .
RESULTS	In RCTs with shorter intervals between vaccine doses it takes longer after the last dose until VE ( acq.dur ) approximates VE ( acq.dur ) .
CONCLUSIONS	The timing of sample collection should be considered when interpreting vaccine efficacy against bacterial carriage measured in RCTs .

###25265403
OBJECTIVE	Adoption of long-acting reversible contraception ( LARC ) ( ie , the intrauterine device or the contraceptive implant ) immediately after abortion is associated with high contraceptive satisfaction and reduced rates of repeat abortion .
OBJECTIVE	Theory-based counseling interventions have been demonstrated to improve a variety of health behaviors ; data on theory-based counseling interventions for postabortion contraception are lacking .
METHODS	Informed by the transtheoretical model of behavioral change , a video intervention was developed to increase awareness of , and dispel misconceptions about , LARC methods .
METHODS	The intervention was evaluated in a randomized controlled trial among women aged 18-29 years undergoing surgical abortion at a clinic in Chicago , IL .
METHODS	Participants were randomized 1:1 to watch the intervention video or to watch a stress management video ( control ) , both 7 minutes in duration .
METHODS	Contraceptive methods were supplied to all participants free of charge .
METHODS	Rates of LARC initiation immediately after abortion were compared .
RESULTS	Rates of LARC initiation immediately after abortion were not significantly different between the 2 study arms ; 59.6 % in the intervention and 51.6 % in the control arm chose a LARC method ( P = .27 ) .
CONCLUSIONS	This study resulted in an unexpectedly high rate of LARC initiation immediately after abortion .
CONCLUSIONS	High rates of LARC initiation could not be attributed to a theory-based counseling intervention .

###25194951
BACKGROUND	Early neurocognitive changes in emotional processing are seen following SSRI administration , which may be involved in mechanisms of action .
BACKGROUND	However , the perceptual processes underpinning these effects have not been specified .
METHODS	In a double-blind , placebo-controlled eye-tracking study , we assessed the effect of single dose of citalopram ( 20mg ) in 25 healthy females .
METHODS	Face stimuli with direct and averted gaze were presented while visual scan patterns and pupil sizes were monitored .
METHODS	Subjective state was monitored using visual analogue scales .
RESULTS	There were no significant effects of citalopram on subjective state .
RESULTS	However , the citalopram group displayed increased saccade numbers and shorter fixation duration during face viewing compared to the placebo group .
RESULTS	Volunteers receiving citalopram also showed reduced monitoring of the eye region irrespective of the direct or averted eye position of the stimuli .
RESULTS	The citalopram group also showed significantly larger pupil sizes than the control group .
CONCLUSIONS	These results suggest that the SSRI administration affects the perceptual processing of face stimuli .
CONCLUSIONS	The current pattern of findings is consistent with anxiogenic-like mechanisms early on in SSRI treatment .
CONCLUSIONS	Eye-tracking provides a novel method to characterise and detect these effects .

###24612093
BACKGROUND	The need for new effective Helicobacter pylori eradication therapy has focused efforts on the development and optimization of regimens with excellent eradication rates such as 14-day hybrid therapy .
BACKGROUND	This study evaluated whether the duration of hybrid therapy could be reduced while maintaining a high eradication rate and to examine the effect of antibiotic resistance on outcome .
METHODS	Three separate multicenter pilot studies were carried out concurrently .
METHODS	To reduce selection bias , eligible subjects were randomized to 10-day , 12-day , or 14-day hybrid therapy consisting of esomeprazole 40 mg and amoxicillin 1 gm twice daily for 10 , 12 , or 14 days plus clarithromycin 500 mg , and metronidazole 500 mg twice daily for the final 7 days .
METHODS	The primary outcome was H.pylori eradication per-protocol assessed at least 8weeks after therapy .
RESULTS	A total of 220 subjects were entered .
RESULTS	The per-protocol analyses contained 60 , 61 , 61 subjects in the 10 - , 12 - and 14-day therapy studies , respectively .
RESULTS	The eradication rates , per-protocol , were similar : 95 % ( 95 % confidence interval ( CI ) ; 89.5-100 % ) for 10-day , 95.1 % ( 95 % CI ; 89.7-100 % ) for 12-day , and 93.4 % ( 95 % CI ; 87.2-99 .7 % ) for 14-day hybrid therapies .
RESULTS	Antibiotic resistance was infrequent ; however , all metronidazole or clarithromycin resistances were cured with 12 - and 14-day therapies .
CONCLUSIONS	These results suggest that in regions of moderate to low clarithromycin and/or metronidazole resistance it may be feasible to shorten hybrid therapy to 10 or 12days .
CONCLUSIONS	Further study is needed to compare hybrid and concomitant therapy in regions with moderate-to-high clarithromycin and/or metronidazole resistance .

###24246541
BACKGROUND	It is not clear whether subgroups of patients with peripheral artery disease ( PAD ) and claudication respond more favorably to exercise rehabilitation than others .
BACKGROUND	We determined whether sex and diabetes were factors associated with the response to exercise rehabilitation in patients with claudication .
METHODS	Eighty patients were randomized to home-based and supervised exercise programs , and 60 finished with complete exercise intervention data .
METHODS	Exercise consisted of intermittent walking to near maximal claudication pain for 3 months .
METHODS	Primary outcome measures included claudication onset time ( COT ) and peak walking time .
METHODS	Patients were partitioned into diabetic and nondiabetic groups and then further partitioned by sex to form four groups .
RESULTS	Overall , exercise adherence was high ( 84 % ) , and there was no significant difference ( P > .05 ) in the amount of exercise completed among the four groups .
RESULTS	All groups had significant improvements ( P < .05 ) in COT and peak walking time after exercise rehabilitation , except for diabetic women ( P > .05 ) .
RESULTS	Only 37 % of women with diabetes had an increase in COT compared with 100 % of men with diabetes ( P < .01 ) , and their risk ratio for nonresponse was 9.2 ( P < .0001 ) .
CONCLUSIONS	Women with PAD and claudication , particularly those with diabetes , represent a vulnerable subgroup of patients who respond poorly to a program of exercise rehabilitation .
CONCLUSIONS	Diabetic women with PAD and claudication may need a greater dose of exercise or another intervention separate from or in combination with exercise to elicit improvements in claudication measures that are similar to nondiabetic women and to diabetic and nondiabetic men .

###25270383
OBJECTIVE	To determine the effects of intratesticular and incisional injection of local anesthetics on response to castration , surgical ease , and recovery in alpacas .
METHODS	Prospective , blinded , randomized , and clinical trial .
METHODS	Intact male alpacas ( n = 38 ) .
METHODS	Alpacas were anesthetized with intramuscular butorphanol , ketamine , and xylazine ( BKX ) .
METHODS	Once recumbent , alpacas were instrumented with electrocardiogram , pulse oximeter , oscillometric blood pressure , and capnography .
METHODS	Heart rate ( HR ) , respiratory rate ( RR ) , and blood pressure ( BP ) were recorded every minute .
METHODS	Treatment drug ( lidocaine , bupivacaine , or saline ) was infiltrated along the incision and into both testicles followed by a prescrotal closed castration .
METHODS	Timing of major events , presence of movement during the procedure , need for additional anesthesia , and ease of surgery were recorded .
METHODS	Alpacas were administered postoperative oral meloxicam and assessment was made 24hours after recovery .
RESULTS	Median RR and mean BP ( MBP ) were lower in the lidocaine compared with the saline treated group .
RESULTS	Median RR , HR , and MBP were significantly lower in the bupivacaine group compared with the saline group .
RESULTS	Fewer alpacas displayed physical response to surgical stimulus with bupivacaine .
RESULTS	No significant differences were found between groups for timing of events , need for additional anesthesia , ease of surgery , or postoperative assessment .
CONCLUSIONS	Intratesticular local anesthetic blunts autonomic response and facilitates castration in alpacas anesthetized with BKX with minimal negative effects .
CONCLUSIONS	Bupivacaine may have some benefit for local anesthesia during castration compared with lidocaine .

###24405575
BACKGROUND	Alcohol-related violence in and in the vicinity of licensed premises continues to place a considerable burden on the United Kingdom 's ( UK ) health services .
BACKGROUND	Robust interventions targeted at licensed premises are therefore required to reduce the costs of alcohol-related harm .
BACKGROUND	Previous evaluations of interventions in licensed premises have a number of methodological limitations and none have been conducted in the UK .
BACKGROUND	The aim of the trial was to determine the effectiveness of the Safety Management in Licensed Environments intervention designed to reduce alcohol-related violence in licensed premises , delivered by Environmental Health Officers , under their statutory authority to intervene in cases of violence in the workplace .
METHODS	A national randomised controlled trial , with licensed premises as the unit of allocation .
METHODS	Premises were identified from all 22 Local Authorities in Wales .
METHODS	Eligible premises were those with identifiable violent incidents on premises , using police recorded violence data .
METHODS	Premises were allocated to intervention or control by optimally balancing by Environmental Health Officer capacity in each Local Authority , number of violent incidents in the 12months leading up to the start of the project and opening hours .
METHODS	The primary outcome measure is the difference in frequency of violence between intervention and control premises over a 12month follow-up period , based on a recurrent event model .
METHODS	The trial incorporates an embedded process evaluation to assess intervention implementation , fidelity , reach and reception , and to interpret outcome effects , as well as investigate its economic impact .
CONCLUSIONS	The results of the trial will be applicable to all statutory authorities directly involved with managing violence in the night time economy and will provide the first formal test of Health and Safety policy in this environment .
CONCLUSIONS	If successful , opportunities for replication and generalisation will be considered .
BACKGROUND	UKCRN 14077 ; ISRCTN78924818 .

###25167690
BACKGROUND	A high prevalence of iron deficiency anemia persists in Bedouin Arab and Jewish pediatric populations in southern Israel .
OBJECTIVE	To compare the effect of daily use of the micronutrient supplementation ( MMS ) , `` Sprinkles , '' a powdered formulation of iron , vitamins A and C , folic acid and zinc , with liquid iron and vitamins A and D on iron deficiency at 12 months of age .
METHODS	The 621 eligible Bedouin and Jewish infants in the study were assigned to the MMS and control arms and received supplementations from age 6 to 12 months .
METHODS	We examined the change in hemoglobin , hematocrit , mean cell volume , red blood cell distribution , serum ferritin and transferrin saturation .
METHODS	In addition , we used the high Iron Deficiency Index ( IDI ) if two or more of the above six parameters showed abnormal levels .
RESULTS	Rates of anemia decreased significantly over the 6 month period , from 58.8 % to 40.6 % among Bedouin infants ( P = 0.037 ) and from 40.6 to 15.8 % among Jewish infants ( P = 0.017 ) .
RESULTS	In Bedouin infants the prevalence of high IDI decreased significantly from 79.2 % to 67.4 % ( P = 0.010 ) in the MMS group , but there was no change in the controls .
RESULTS	Among Jewish infants , the high IDI prevalence decreased from 67 % to 55.6 % with no statistically significant difference in the two study arms .
RESULTS	In the multivariate analysis in Bedouin infants MMS use was associated with a reduced risk of 67 % in high IDI at age 12 months as compared to controls ( P = 0.001 ) .
RESULTS	Fewer side effects in the intervention groups in both ethnic populations were reported .
CONCLUSIONS	MMS fortification of home food can be recommended as an effective and safe method for preventing iron deficiency anemia at 12 months of age .

###25537278
OBJECTIVE	To study the effect of a dietary supplement ( TARGET 1 : a combination of casozepine , taurine , Eleutherococcus senticosus and extramel ) on burnout symptomatology .
METHODS	A 12-week , double-blind , randomized , placebo-controlled trial was conducted in workers engaged in professional contact with patients , students or clients .
METHODS	All were affected by burnout syndrome based on a score of 4 on the Burnout Measure Scale ( BMS-10 ) .
METHODS	The primary outcome measure was the change in the BMS-10 score ; secondary outcome measures included the change in the Maslach 's Burnout Inventory scale-Human Service Survey ( MBI-HSS ) score and the Beck Depression Inventory .
METHODS	Five scores were evaluated .
RESULTS	Eighty-seven participants were enrolled in the study : 44 received the active formulation ( verum group ) ; 43 received placebo .
RESULTS	After 12 weeks ' supplementation , the placebo group showed significant improvements in scores for BMS-10 , MBI-HSS fatigue and the Beck Depression Inventory , but MBI-HSS depersonalization and task management were not improved ; the verum group showed significant improvements in all five scores .
RESULTS	The verum group consistently showed significantly greater improvements in scores than the placebo group .
CONCLUSIONS	TARGET 1 significantly improved the symptoms of burnout after 12 weeks ' use .

###25671826
BACKGROUND	Among the available nucleos ( t ) ide analogues adefovir dipivoxil ( ADV ) is relatively cheap and widely used in rural area in China .
BACKGROUND	However , there are insufficient data on recommendation for patients with suboptimal response to ADV after 48 weeks of treatment in order to reduce the resistance rate in the long term .
BACKGROUND	The aim of this study was to compare the efficacy and safety of LAM add-on combination therapy versus ETV monotherapy for patients with suboptimal response to ADV.
METHODS	136 patients with suboptimal response to ADV were randomly assigned to the add-on LAM with ADV combination therapy ( 68 patients ) group and the ETV monotherapy ( 68 patients ) group .
METHODS	Patients in the add-on group were prescribed 100 mg LAM and 10 mg ADV per day , while the monotherapy group received 0.5 mg ETV per day for 48 weeks .
METHODS	Tests for liver and kidney function , HBV serum markers , HBV DNA load , were performed every 3 months .
RESULTS	The mean patient age in LAM add-on group and ETV monotherapy was 38.59 7.65 and 37.56 8.67 years respectively .
RESULTS	The HBV DNA undetectable rate in the LAM add-on group and the ETV group were not significant difference at week 4 , 12 and 24 ( P > 0.05 ) .
RESULTS	However , the HBV undetectable rate in the ETV group was higher than that in the LAM add-on group at week 36 and 48 ( P = 0.043 for week 36 and P = 0.038 for week 48 ) .
RESULTS	There was no significant difference both for HBeAg loss and HBeAg seroconversion between two groups ( P > 0.05 ) at 48 weeks .
RESULTS	Meanwhile , our study also demonstrated that the mean eGFR levels in LAM add-on group was decreased from 99.6 8.71 at baseline to 86.4 9.83 at the end of 48 weeks , which was significantly higher than that in the ETV monotherapy group ( P < 0.05 ) .
RESULTS	8.8 % of patients in LAM add-on group experienced eGFR reduction by 20-30 % from baseline at 48 weeks .
RESULTS	No patients developed hyposphosphatemia in our study .
CONCLUSIONS	Our study clearly showed that switch to ETV monotherapy was the more effective and more safe than that of LAM add-on combination therapy for patients with suboptimal response to ADV.

###25035351
BACKGROUND	A good patch test system should have good adhesion and contact , and minimal leakage ; Finn and IQ patch test system have these properties but are expensive .
OBJECTIVE	To develop a new cost-effective occlusive patch test system that had good contact with the skin and was non-irritant .
METHODS	The system ( designated Chamber X ) was fabricated using a semi-permeable tape and a flexible virgin plastic chamber .
METHODS	Chamber X was developed by ( i ) selecting adhesive tape based on its non irritancy and adhesive potential ( ii ) testing plastic chamber material for its skin irritancy ( iii ) testing the assembled system against Finn , IQ and locally available chambers for irritancy , contact , leakage and occlusivity .
RESULTS	Chamber X showed better occlusion than IQ , Finn and locally available chambers and was comparable to , ( P > 0.05 ) IQ and Finn in terms of irritancy , contact and leakage .
CONCLUSIONS	The results demonstrate that the Chamber X offers a cost effective patch test system comparable to IQ and Finn chambers in terms of safety , adhesion , leakage and occlusivity .

###25137842
OBJECTIVE	To explore the effect of acupuncture-anesthetic composite anesthesia ( AACA ) on the incidence of postoperative cognitive dysfunction ( POCD ) and changes of TNF-alpha , IL-1beta , and IL-6 in elderly patients .
METHODS	Totally 83 patients undergoing surgical resection of gastrointestinal tumor were randomly assigned to the simple anesthesia group ( A group , 41 cases ) and the AACA group ( B group , 42 cases ) .
METHODS	Patients in Group A received endotracheal general anesthesia .
METHODS	Those in Group B were induced by acupuncture anesthesia for 30 min by needling at Baihui ( DU20 ) , Neiguan ( PC6 ) , Zusanli ( ST36 ) .
METHODS	The electro-acupuncture ( EA ) apparatus was connected after arrival of qi , with the wave pattern of density 2/100 Hz .
METHODS	The stimulus intensity was set by patients ' tolerance , with the peak current of 5 mA .
METHODS	Then the endotracheal general anesthesia was performed and the EA lasted till the end of the surgery .
METHODS	The cognitive function of all patients was assessed before operation and at day 3 after operation using mini-mental state examination ( MMSE ) .
METHODS	POCD was confirmed if with one or more decreased stand - ard .
METHODS	The peripheral venous blood was collected before anesthesia induction ( TO ) , immediately at the end of surgery ( T1 ) , 24 h after operation ( T2 ) , and 48 h after operation ( T3 ) , and serum concentrations of IL-1beta , IL-6 , and TNF-alpha were correspondingly measured using ELISA .
RESULTS	The postoperative anesthesia awakening time was shorter in Group B than in Group A [ ( 20.37 + / - 6.09 ) min vs ( 29.24 + / - 7.48 ) min , P < 0.05 ] .
RESULTS	The remifentanil dose used during the operation was less in Group B than in Group A ( P < 0.05 ) .
RESULTS	The incidence of POCD at day 3 was lower in Group B than in Group A [ 10/41 ( 23.8 % ) vs 15/42 ( 36.5 % ) , P < 0.05 ] .
RESULTS	The concentrations of IL-1beta , IL-6 , and TNF-alpha at T1-T3 were higher than those at TO in the two groups ( P < 0.05 ) .
RESULTS	The increment of TNF-alpha and IL-1beta was less in Group B than in Group A ( P < 0.05 ) .
RESULTS	CONCLUSION AACA could reduce the incidence of POCD and inhibit postoperative release of TNF-alpha , IL-1beta , and IL-6 in elderly patients undergoing colorectal cancer resection .

###25479118
OBJECTIVE	To determine if a video depicting cardiopulmonary resuscitation and resuscitation preference options would improve knowledge and decision making among patients and surrogates in the ICU .
METHODS	Randomized , unblinded trial .
METHODS	Single medical ICU .
METHODS	Patients and surrogate decision makers in the ICU .
METHODS	The usual care group received a standard pamphlet about cardiopulmonary resuscitation and cardiopulmonary resuscitation preference options plus routine code status discussions with clinicians .
METHODS	The video group received usual care plus an 8-minute video that depicted cardiopulmonary resuscitation , showed a simulated hospital code , and explained resuscitation preference options .
RESULTS	One hundred three patients and surrogates were randomized to usual care .
RESULTS	One hundred five patients and surrogates were randomized to video plus usual care .
RESULTS	Median total knowledge scores ( 0-15 points possible for correct answers ) in the video group were 13 compared with 10 in the usual care group , p value of less than 0.0001 .
RESULTS	Video group participants had higher rates of understanding the purpose of cardiopulmonary resuscitation and resuscitation options and terminology and could correctly name components of cardiopulmonary resuscitation .
RESULTS	No statistically significant differences in documented resuscitation preferences following the interventions were found between the two groups , although the trial was underpowered to detect such differences .
RESULTS	A majority of participants felt that the video was helpful in cardiopulmonary resuscitation decision making ( 98 % ) and would recommend the video to others ( 99 % ) .
CONCLUSIONS	A video depicting cardiopulmonary resuscitation and explaining resuscitation preference options was associated with improved knowledge of in-hospital cardiopulmonary resuscitation options and cardiopulmonary resuscitation terminology among patients and surrogate decision makers in the ICU , compared with receiving a pamphlet on cardiopulmonary resuscitation .
CONCLUSIONS	Patients and surrogates found the video helpful in decision making and would recommend the video to others .

###25526229
OBJECTIVE	This study examines the efficacy of the buprenorphine transdermal system ( BTDS ) for reducing the interference of pain on physical and emotional functioning associated with chronic low back pain ( CLBP ) .
METHODS	A post-hoc analysis used data from a randomized , placebo-controlled , double-blind trial of patients with moderate-to-severe CLBP .
METHODS	The Brief Pain Inventory ( BPI ) measured pain interference at screening , following a run-in period , and during the 12-week double-blind treatment phase .
METHODS	Statistical analyses examined treatment arm differences ( BTDS vs placebo ) for the following : BPI Interference subscale items and subscale scores at the trial end point ( week 12 ) ; patterns of change in the Interference subscale scores over time ; proportions of patients indicating mild or no interference following treatment ; and proportions of patients showing improvement ( 30 % , 50 % , 2-point , or 4-point change in score from screening to week 12 ) for each item and subscale .
RESULTS	Mean scores for BPI Interference items and Interference subscale were significantly lower ( ie , indicated less interference ) for BTDS than for placebo ( all P < 0.001 ) .
RESULTS	Treatment arm differences in Interference subscale scores emerged within 4 weeks of treatment .
RESULTS	The BTDS patients were significantly more likely to indicate mild/no interference on 5 of 7 Interference subscale items following treatment ( P < 0.05 ) .
RESULTS	For most comparisons , BTDS patients were significantly more likely to show criterion-level improvements in Interference item and subscale scores ( P < 0.05 for differences ) .
CONCLUSIONS	Results indicate the efficacy of BTDS treatment , compared with placebo , for reducing the interference of pain on physical and emotional functioning in patients with moderate-to-severe CLBP .
CONCLUSIONS	The advantage of BTDS was observed within 4 weeks of treatment , and was maintained throughout the 12-week treatment phase .

###24682504
BACKGROUND	Although the effects of caffeine on basic cognitive functions are well-known , its effects on more complex decision making , particularly on option generation , is yet to be explored .
OBJECTIVE	We examined the effects of caffeine on option generation in decision making using everyday life decisional situations .
METHODS	In a double-blind placebo-controlled experiment , participants ( N = 47 ) either received 300 mg of caffeine or a placebo .
METHODS	Participants had to generate choice options ( things they could do ) for a series of high and low familiar real-world scenarios and , subsequently , to decide among these options .
RESULTS	Analyses revealed that participants in the caffeine condition generated significantly fewer options than participants in the placebo condition .
RESULTS	Moreover , caffeine significantly reduced the option generation onset time , that is , participants in the caffeine condition generated their first option significantly faster than participants in the placebo condition .
RESULTS	Regarding subsequent choice , we found evidence supporting the `` take-the-first '' heuristic , that is , the tendency to select the first generated option .
RESULTS	This tendency was neither affected by caffeine nor by the familiarity of the scenarios .
CONCLUSIONS	Caffeine results in fewer options generated in unconstrained real-life decision-making situations and decreases generation onset times .

###25011949
OBJECTIVE	Previous studies demonstrated that the anti-CD3 monoclonal antibody otelixizumab , administered at a total dose of 48-64 mg , can slow the loss of C-peptide in recent-onset type 1 diabetes patients , with frequent reactivation of Epstein Barr virus ( EBV ) .
OBJECTIVE	The DEFEND-1 ( Durable Response Therapy Evaluation for Early or New-Onset Type 1 Diabetes ) trial was designed to test whether a lower dose of otelixizumab could preserve C-peptide secretion in new-onset type 1 diabetes patients .
METHODS	A multicenter , randomized , placebo-controlled trial was performed in sites in the U.S. , Canada , and Europe .
METHODS	Two hundred eighty-one patients were randomized to treatment with 3.1 mg otelixizumab administered over 8 days or placebo .
METHODS	The primary end point of the study was the change in C-peptide area under the curve ( AUC ) from a 2-h mixed-meal tolerance test at month 12 .
RESULTS	The change in 2-h C-peptide AUC was not different between placebo-treated patients and otelixizumab-treated patients ( -0.20 vs. -0.22 nmol/L , P = 0.81 ) .
RESULTS	Secondary end points , including HbA1c , glucose variability , and insulin dose , were also not statistically different between the two groups .
RESULTS	More patients in the otelixizumab group than in the placebo group experienced adverse events , mostly grade 1 or grade 2 .
RESULTS	There was no EBV reactivation ( viral load > 10,000 copies/10 ( 6 ) peripheral blood mononuclear cells ) in the otelixizumab group , in contrast with previously published studies at higher doses of otelixizumab .
CONCLUSIONS	Otelixizumab was well tolerated in patients with recent-onset type 1 diabetes at a total dose of 3.1 mg , but did not achieve preservation of levels of C-peptide or other markers of metabolic control .

###25005572
BACKGROUND	It is well established that insecticide-treated bed nets ( ITNs ) , in particular long-lasting , insecticidal nets ( LLINs ) , can be used as one of the primary interventions for effective malaria control .
BACKGROUND	A consistent gap between net ownership and use has been observed , indicating that factors exist that prevent an owned mosquito net from being used .
BACKGROUND	One approach used in the context of LLIN campaigns is a post-distribution , door-to-door visit of households with educational messages and to physically assist with hang-up of nets .
METHODS	A cluster randomized trial was conducted in the Plateaux Region of Togo to evaluate the effectiveness of different approaches to post-LLIN campaign home visits ( number of visits and timing ) by volunteers to enhance LLIN hang-up and utilization .
RESULTS	It was found that , in general , households that received intervention visits , particularly the most recent intervention visit , had levels of use that were typically 5 to 10 % higher than the control households , while access did not differ among control and intervention households .
RESULTS	Eight months post-campaign , ITN use by all individuals , children under five years and women of reproductive age was 11.3 to 14.4 percentage points greater in the study arm that received all three intervention visits than in the control communities .
RESULTS	In households that received one or two additional door-to-door visits , the majority of respondents indicated that the volunteer provided new information during the visit regarding the use and importance of ITNs despite having received previous multiple visits .
CONCLUSIONS	The impact of the interventions appears to have been primarily through the delivery and reinforcement of key behaviour-change communication ( BCC ) messages regarding the importance of using an ITN and its care .
CONCLUSIONS	Regardless of whether the respondents in fact received new information or had forgotten earlier information , this suggests that regular visits from community agents are useful in reinforcing key BCC messages .

###24793941
OBJECTIVE	To increase childhood influenza vaccination rates using a toolkit and early vaccine delivery in a randomized cluster trial .
METHODS	Twenty primary care practices treating children ( range for n = 536-8183 ) were randomly assigned to Intervention and Control arms to test the effectiveness of an evidence-based practice improvement toolkit ( 4 Pillars Toolkit ) and early vaccine supplies for use among disadvantaged children on influenza vaccination rates among children 6 months-18 years .
METHODS	Follow-up staff meetings and surveys were used to assess use and acceptability of the intervention strategies in the Intervention arm .
METHODS	Rates for the 2010-2011 and 2011-2012 influenza seasons were compared .
METHODS	Two-level generalized linear mixed modeling was used to evaluate outcomes .
RESULTS	Overall increases in influenza vaccination rates were significantly greater in the Intervention arm ( 7.9 percentage points ) compared with the Control arm ( 4.4 percentage points ; P < 0.034 ) .
RESULTS	These rate changes represent 4522 additional doses in the Intervention arm vs. 1390 additional doses in the Control arm .
RESULTS	This effect of the intervention was observed despite the fact that rates increased significantly in both arms - 8/10 Intervention ( all P < 0.001 ) and 7/10 Control sites ( P-values = 0.04 to < 0.001 ) .
RESULTS	Rates in two Intervention sites with pre-intervention vaccination rates > 58 % did not significantly increase .
RESULTS	In regression analyses , a child 's likelihood of being vaccinated was significantly higher with : younger age , white race ( Odds ratio [ OR ] = 1.29 ; 95 % confidence interval [ CI ] = 1.23-1 .34 ) , having commercial insurance ( OR = 1.30 ; 95 % CI = 1.25-1 .35 ) , higher pre-intervention practice vaccination rate ( OR = 1.25 ; 95 % CI = 1.16-1 .34 ) , and being in the Intervention arm ( OR = 1.23 ; 95 % CI = 1.01-1 .50 ) .
RESULTS	Early delivery of influenza vaccine was rated by Intervention practices as an effective strategy for raising rates .
CONCLUSIONS	Implementation of a multi-strategy toolkit and early vaccine supplies can significantly improve influenza vaccination rates among children in primary care practices but the effect may be less pronounced in practices with moderate to high existing vaccination rates .
CONCLUSIONS	Clinical trial registry name/number : From Innovation to Solutions : Childhood Influenza/NCT01664793 .

###25499599
OBJECTIVE	To determine the effectiveness of an early physiotherapy intervention for the prevention of secondary lymphoedema on health-related quality of life in women who also received an education program after breast cancer surgery .
METHODS	One hundred and fifty three women diagnosed with unilateral breast cancer ( stage I-II ) treated with breast surgery , which included axillary lymph-node dissection , from Hospital Prncipe de Asturias , Alcal de Henares , Madrid ( Spain ) were randomly assigned into two groups .
METHODS	Subjects in early physiotherapy group ( n = 76 ) received a physiotherapy intervention combined with a therapeutic education program ; women in the control group ( n = 77 ) received only the therapeutic education program .
METHODS	Both interventions were delivered by two different physiotherapists of Physiotherapy in Women 's Health Research Group at Physiotherapy Department of Alcala University .
METHODS	Health related quality of life was measured with EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires in 5 assessments : after surgery just before group interventions started ( A1 ) , after the 3-week group interventions finished ( A2 ) ; and a follow-up period in 3 ( A3 ) , 6 ( A4 ) and 12 ( A5 ) months after surgical intervention .
RESULTS	Greater change in quality of life was observed for early physiotherapy group arm compared to control group , although no strong statistical evidence was found ( p > .05 ) for most of the dimensions except for physical function and social function areas ( p < .003 ) .
CONCLUSIONS	The control group with therapeutic education program reported a clear improvement in the perception of quality of life .
CONCLUSIONS	Adding early physiotherapy to the therapeutic education program did not show statistically significant changes in the global score or in most of the dimensions , but showed an improvement in the physical and social dimensions .

###25373724
BACKGROUND	Myofascial pain syndrome ( MPS ) in the shoulder is among the most prevalent pain problems in the middle-aged population worldwide .
BACKGROUND	Evidence suggests that peripheral and central sensitization may play an important role in the development and maintenance of shoulder MPS .
BACKGROUND	Given previous research supporting the potential efficacy of anodal transcranial direct current stimulation ( tDCS ) for modulating pain-related brain activity in individuals with refractory central pain , we hypothesized that anodal tDCS when applied over the primary motor cortex ( M1 ) combined with standard treatment will be more effective for reducing pain in patients with MPS than standard treatment alone .
METHODS	Study participants were randomized to receive either ( 1 ) standard treatment with 5 consecutive days of 1 mA anodal tDCS over M1 for 20 minutes ; or ( 2 ) standard treatment plus sham tDCS .
METHODS	Measures of pain intensity , shoulder passive range of motion ( PROM ) , analgesic medication use , and self-reported physical functioning were administered before treatment and again at posttreatment and 1 - , 2 - , 3 - , and 4-week follow-up .
RESULTS	Thirty-one patients with MPS were enrolled .
RESULTS	Participants assigned to the active tDCS condition reported significantly more pretreatment to posttreatment reductions in pain intensity that were maintained at 1-week posttreatment , and significant improvement in shoulder adduction PROM at 1-week follow-up than participants assigned to the sham tDCS condition .
CONCLUSIONS	Five consecutive days of anodal tDCS over M1 combined with standard treatment appears to reduce pain intensity and may improve PROM , faster than standard treatment alone .
CONCLUSIONS	Further tests on the efficacy and duration of effects of tDCS in the treatment of MPS are warranted .

###24762366
BACKGROUND	There are a wide variety of non - pharmacologic pain relief techniques for labor which include pelvic movement , upright position , back massage and partner support during the first stage of labor .
BACKGROUND	The effectiveness of dance labor - which is a combination of these techniques - has not been evaluated .
OBJECTIVE	This study aimed to evaluate the effectiveness of dance labor in pain reduction and woman 's satisfaction during the first stage of labor .
METHODS	60 primiparous women aged 18-35 years old were randomly assigned to dance labor and control groups .
METHODS	In the dance labor group , women were instructed to do standing upright with pelvic tilt and rock their hips back and forth or around in a circle while their partner massaged their back and sacrum for a minimum of 30 minutes .
METHODS	In the control group , the participants received usual care during physiologic labor .
METHODS	Pain and satisfaction scores were measured by Visual Analogue Scale .
METHODS	Data were analyzed by using the t. test and Chi-square .
RESULTS	Mean pain score in the dance labor group was significantly lower than the control group ( P < 0.05 ) .
RESULTS	The mean satisfaction score in the dance labor group was significantly higher than in the control group ( P < 0.05 ) .
CONCLUSIONS	Dance labor which is a complementary treatment with low risk can reduce the intensity of pain and increase mothers , satisfaction with care during the active phase of labor .

###24269362
OBJECTIVE	The study sought to evaluate the relationship between procedural volume and outcomes with radial and femoral approach .
BACKGROUND	RIVAL ( RadIal Vs. femorAL ) was a randomized trial of radial versus femoral access for coronary angiography/intervention ( N = 7,021 ) , which overall did not show a difference in primary outcome of death , myocardial infarction , stroke , or non-coronary artery bypass graft major bleeding .
METHODS	In pre-specified subgroup analyses , the hazard ratios for the primary outcome were compared among centers divided by tertiles and among individual operators .
METHODS	A multivariable Cox proportional hazards model was used to determine the independent effect of center and operator volumes after adjusting for other variables .
RESULTS	In high-volume radial centers , the primary outcome was reduced with radial versus femoral access ( hazard ratio [ HR ] : 0.49 ; 95 % confidence interval [ CI ] : 0.28 to 0.87 ) but not in intermediate - ( HR : 1.23 ; 95 % CI : 0.88 to 1.72 ) or low-volume centers ( HR : 0.83 ; 95 % CI : 0.52 to 1.31 ; interaction p = 0.021 ) .
RESULTS	High-volume centers enrolled a higher proportion of ST-segment elevation myocardial infarction ( STEMI ) .
RESULTS	After adjustment for STEMI , the benefit of radial access persisted at high-volume radial centers .
RESULTS	There was no difference in the primary outcome between radial and femoral access by operator volume : high-volume operators ( HR : 0.79 ; 95 % CI : 0.48 to 1.28 ) , intermediate ( HR : 0.87 ; 95 % CI : 0.60 to 1.27 ) , and low ( HR : 1.10 ; 95 % CI : 0.74 to 1.65 ; interaction p = 0.536 ) .
RESULTS	However , in a multivariable model , overall center volume and radial center volume were independently associated with the primary outcome but not femoral center volume ( overall percutaneous coronary intervention volume HR : 0.92 , 95 % CI : 0.88 to 0.96 ; radial volume HR : 0.88 , 95 % CI : 0.80 to 0.97 ; and femoral volume HR : 1.00 , 95 % CI : 0.94 to 1.07 ; p = 0.98 ) .
CONCLUSIONS	Procedural volume and expertise are important , particularly for radial percutaneous coronary intervention .
CONCLUSIONS	( A Trial of Trans-radial Versus Trans-femoral Percutaneous Coronary Intervention [ PCI ] Access Site Approach in Patients With Unstable Angina or Myocardial Infarction Managed With an Invasive Strategy [ RIVAL ] ; NCT01014273 ) .

###24945085
OBJECTIVE	The purpose of this study was to assess the effect of guanfacine extended release ( GXR ) adjunctive to a psychostimulant on oppositional symptoms in children and adolescents with attention-deficit/hyperactivity disorder ( ADHD ) .
METHODS	A multicenter , double-blind , placebo-controlled dose-optimization study of GXR ( 1-4mg / d ) or placebo administered morning ( a.m. ) or evening ( p.m. ) adjunctive to psychostimulant was conducted in subjects ages 6-17 with suboptimal response to psychostimulant alone .
METHODS	Suboptimal response was defined as treatment with a stable dose of psychostimulant for 4 weeks with ADHD Rating Scale IV total score 24 and Clinical Global Impressions-Severity of Illness score 3 , as well as investigator opinion .
METHODS	Primary efficacy and safety results have been reported previously .
METHODS	Secondary efficacy measures included the oppositional subscale of the Conners ' Parent Rating Scale-Revised : Long Form ( CPRS-R : L ) ; these are reported herein .
RESULTS	Significant reductions from baseline to the final on-treatment assessment on the oppositional subscale of the CPRS-R : L were seen with GXR plus psychostimulant compared with placebo plus psychostimulant , both in the overall study population ( placebo-adjusted least squares [ LS ] mean change from baseline to the final on-treatment assessment : GXR a.m. + psychostimulant , -2.4 , p = 0.001 ; GXR p.m. + psychostimulant , -2.2 , p = 0.003 ) as well as in the subgroup of subjects with significant baseline oppositional symptoms ( GXR a.m. + psychostimulant , -3.6 , p = 0.001 ; GXR p.m. + psychostimulant , -2.7 , p = 0.013 ) .
RESULTS	Treatment-emergent adverse events were reported by 77.3 % , 76.3 % , and 63.4 % of subjects in the GXR a.m. , GXR p.m. , and placebo groups , respectively , in the overall study population .
CONCLUSIONS	GXR adjunctive to a psychostimulant significantly reduced oppositional symptoms compared with placebo plus a psychostimulant in subjects with ADHD and a suboptimal response to psychostimulant alone .

###24597922
OBJECTIVE	This paper describes the effectiveness of cognitive stimulation therapy ( CST ) on cognition and depressive symptoms in older adults in nursing homes ( NHs ) .
METHODS	A randomized controlled trial , carried out from 2012 to 2013 , included 56 residents from four NHs , 36 women and 20 men ( randomized into experimental and control groups ) .
METHODS	Eight participants dropped out .
METHODS	Participants of the experimental group underwent 14 CST sessions ( 7 weeks ) in groups of six to eight older adults , and participants of the control group received usual care .
METHODS	The Montreal Cognitive Assessment , the Geriatric Depression Scale-15 , and the Barthel Index of activities of daily living ( ADLs ) were administered at baseline and postintervention .
RESULTS	Repeated measures revealed that CST increased cognition ( F = 8.581 ; p = .005 ; partial squared = 0.157 ; power = 0.82 ) .
RESULTS	There were no statistically significant differences in depressive symptoms ( F = 1.090 ; p = .302 ) .
RESULTS	Baseline level of ADLs did not affect the outcomes .
CONCLUSIONS	CST had significantly improved cognition , explaining the 15.7 % variability , but there was no statistical evidence of its effectiveness on depressive symptoms .
CONCLUSIONS	This improvement was not affected by the baseline level of dependence-independence in ADLs .
CONCLUSIONS	CST offers a range of activities , providing general stimulation for thinking , concentration , and memory , usually in a social setting .
CONCLUSIONS	These results will support implementation of CST in NHs .
CONCLUSIONS	In addition to the impact on elderly independence and autonomy , CST may also have an economic impact by reducing the direct costs of the impact of elders ' cognitive frailty .

###25035208
OBJECTIVE	This study examines the role of ( 18 ) F-labeled fluorodeoxyglucose positron emission tomography ( FDG-PET ) in the implementation of involved-node radiation therapy ( INRT ) in patients treated for clinical stages ( CS ) I/II supradiaphragmatic Hodgkin lymphoma ( HL ) .
METHODS	Patients with untreated CS I/II HL enrolled in the randomized EORTC/LYSA/FIL Intergroup H10 trial and participating in a real-time prospective quality assurance program were prospectively included in this study .
METHODS	Data were electronically obtained from 18 French cancer centers .
METHODS	All patients underwent APET-computed tomography ( PET-CT ) and a post-chemotherapy planning CT scanning .
METHODS	The pre-chemotherapy gross tumor volume ( GTV ) and the postchemotherapy clinical target volume ( CTV ) were first delineated on CT only by the radiation oncologist .
METHODS	The planning PET was then co-registered , and the delineated volumes were jointly analyzed by the radiation oncologist and the nuclear medicine physician .
METHODS	Lymph nodes undetected on CT but FDG-avid were recorded , and the previously determined GTV and CTV were modified according to FDG-PET results .
RESULTS	From March 2007 to February 2010 , 135 patients were included in the study .
RESULTS	PET-CT identified at least 1 additional FDG-avid lymph node in 95 of 135 patients ( 70.4 % ; 95 % confidence interval [ CI ] : 61.9 % -77.9 % ) and 1 additional lymph node area in 55 of 135 patients ( 40.7 % ; 95 % CI : 32.4 % -49.5 % ) .
RESULTS	The mean increases in the GTV and CTV were 8.8 % and 7.1 % , respectively .
RESULTS	The systematic addition of PET to CT led to a CTV increase in 60 % of the patients .
CONCLUSIONS	Pre-chemotherapy FDG-PET leads to significantly better INRT delineation without necessarily increasing radiation volumes .

###25164513
OBJECTIVE	Older cancer survivors are a vulnerable population due to an increased risk for chronic diseases ( e.g. , cardiovascular disease ) compounded with treatment late-effects and declines in physical functioning .
OBJECTIVE	Therefore , interventions that reduce chronic disease risk factors ( i.e. , blood pressure , chronic inflammation , and cortisol ) are important in this population .
OBJECTIVE	Tai chi chih ( TCC ) is a mind-body exercise associated with reductions in chronic disease risk factors , but has not been examined with older cancer survivors .
OBJECTIVE	In a feasibility randomized controlled trial of TCC , we examined secondary outcomes of blood pressure , salivary cortisol , and inflammatory cytokines ( interleukin ( IL ) -6 , IL-12 , tumor necrosis factor - , IL-10 , IL-4 ) due to their implications in chronic diseases .
METHODS	Sixty-three senior female cancer survivors ( M age = 67 years , SD = 7.15 ) with physical functioning limitations ( SF-12 physical functioning 80 or role-physical 72 ) were randomized to 12-weeks ( 60-min , three times a week ) of TCC or Health Education control ( HEC ) classes .
METHODS	Resting blood pressure , 1-day salivary cortisol samples , and fasting plasma samples for cytokine multiplex assays were collected at baseline and 1-week post-intervention .
RESULTS	Controlling for baseline values , the TCC group had significantly lower systolic blood pressure ( SBP , p = 0.002 ) and cortisol area-under-curve ( AUC , p = 0.02 ) at post-intervention than the HEC group .
RESULTS	There was no intervention effect on inflammatory cytokines ( p 's > 0.05 ) .
CONCLUSIONS	This TCC feasibility trial was associated with significant reductions in SBP and cortisol AUC in senior female cancer survivors .
CONCLUSIONS	Larger , definitive trials are needed to confirm these findings .
CONCLUSIONS	Senior survivors ' have an increased risk for chronic diseases ; however , TCC interventions may help reduce associated risk factors .

###24980739
BACKGROUND	Computer-aided design and computer-aided manufacturing ( CAD/CAM ) generated restorations are gaining popularity .
BACKGROUND	However , limited clinical evidence is available for single-unit posterior CAD/CAM restorations fabricated with established and newer crown materials .
OBJECTIVE	The purpose of this clinical study was to assess the restoration quality of and gingival response to CAD/CAM fabricated posterior single-tooth restorations with different processing technologies .
METHODS	Twenty-two individuals in need of posterior complete coverage crowns were recruited under an institutional review board approved protocol .
METHODS	Teeth were randomized to 1 of 3 groups : metal ceramic , lithium disilicate , and monolithic zirconia .
METHODS	An unprepared or minimally restored tooth on the contralateral side was chosen as a control tooth for gingival measurements with each participant .
METHODS	Teeth were prepared and scanned intraorally by 1 of 3 experienced practitioners .
METHODS	A total of 32 restorations were digitally designed and fabricated with either milling technology or rapid-prototype printing and casting with conventional porcelain application .
METHODS	Restorations were evaluated with modified United States Public Health Service criteria for contour , marginal adaptation , occlusion , and shade .
METHODS	Gingival crevicular fluid volume and bleeding on probing were recorded preoperatively , at 1-month and 6-month postcementation visits .
METHODS	Polyvinyl siloxane impressions were made of the buccal margin of cemented restorations and evaluated with microcomputed tomography to assess marginal adaptation ( horizontal discrepancy ) .
METHODS	The Mantel Haenszel row mean score was used to assess whether the crown systems differed with respect to the modified United States Public Health Service criteria .
METHODS	Linear mixed models were used to assess whether the average gingival volumes were affected by the explanatory variables ( crown system , tooth status [ treated vs control ] , or visit ) .
METHODS	A generalized estimating equation approach was used to assess whether bleeding on probing was affected by the explanatory variables .
METHODS	One-way ANOVA was used to assess marginal discrepancy values among the crown systems ( = .05 for all tests ) .
RESULTS	Twelve metal ceramic , 10 lithium disilicate , and 10 zirconia restorations were fabricated for 22 participants .
RESULTS	Zirconia restorations were significantly different from the other 2 crown systems ( P < .001 ) with respect to occlusion .
RESULTS	No occlusal adjustment was needed on 80 % of the zirconia restorations .
RESULTS	The average gingival crevicular fluid volumes did not differ among crown systems , between treated and control groups , or over time .
RESULTS	The average horizontal marginal discrepancy was significantly different between lithium disilicate and zirconia crowns ( P = .027 ) , with zirconia crowns having the least amount of horizontal marginal discrepancy .
CONCLUSIONS	Given the small sample size and limitations of this study , CAD/CAM-generated restorations for posterior teeth made from different materials had acceptable clinical results .

###25496294
BACKGROUND	Fluid removal during dialysis , also known as ultrafiltration ( UF ) , leads to intradialytic hypotension ( IDH ) in a significant number of patients treated with hemodialysis ( HD ) and is associated with an increase in morbidity and mortality .
BACKGROUND	At present , there are no accepted standards of practice for the prevention or treatment of IDH .
BACKGROUND	Relative blood volume monitoring ( BVM ) is based on the concept that the hematocrit increases with UF , relative to the patient 's baseline hematocrit .
BACKGROUND	The use of BVM biofeedback , whereby the HD machine automatically adjusts the rate of UF based on the relative blood volume , has been proposed for the prevention of IDH .
METHODS	This is a 22-week randomized crossover trial .
METHODS	Participants undergo a 4-week run-in phase to standardize medications and dialysis prescriptions .
METHODS	Subsequently , participants are randomized to standard HD or to BVM biofeedback for a period of 8 weeks followed by a 2-week washout phase before crossing over .
METHODS	The dialysis prescription remains identical for both arms .
METHODS	The primary outcome is the frequency of symptomatic IDH as defined by an abrupt drop in the systolic blood pressure of 20 mm Hg accompanied by headache , dizziness , loss of consciousness , thirst , dyspnea , angina , muscle cramps or vomiting .
METHODS	Secondary outcomes include the number of symptomatic IDH episodes and any reduction in IDH episodes , nursing interventions , dialysis adequacy , total body water , extra - and intracellular fluid volumes , brain natriuretic peptide and cardiac troponin levels , blood pressure , antihypertensive medication use , patient symptoms and quality of life .
CONCLUSIONS	Our study will determine the impact of using BVM biofeedback to prevent IDH and other serious adverse events in susceptible patients .
BACKGROUND	Clinicaltrials.gov NCT01988181 ( 6 November 2013 ) .

###25909205
OBJECTIVE	to compare clinical and cost effectiveness of midazolam and diazepam for urgent intubation .
METHODS	patients admitted to the Central ICU of the Santa Casa Hospital Complex in Porto Alegre , over the age of 18 years , undergoing urgent intubation during 6 months were eligible .
METHODS	Patients were randomized in a single-blinded manner to either intravenous diazepam or midazolam .
METHODS	Diazepam was given as a 5 mg intravenous bolus followed by aliquots of 5 mg each minute .
METHODS	Midazolam was given as an intravenous bolus of 5 mg with further aliquots of 2.5 mg each minute .
METHODS	Ramsay sedation scale 5-6 was considered adequate sedation .
METHODS	We recorded time and required doses to reach adequate sedation and duration of sedation .
RESULTS	thirty four patients were randomized , but one patient in the diazepam group was excluded because data were lost .
RESULTS	Both groups were similar in terms of illness severity and demographics .
RESULTS	Time for adequate sedation was shorter ( 132 87 sec vs. 224 117 sec , p = 0.016 ) but duration of sedation was similar ( 86 67 min vs. 88 50 min , p = 0.936 ) for diazepam in comparison to midazolam .
RESULTS	Total drug dose to reach adequate sedation after either drugs was similar ( 10.0 [ 10.0-12 .5 ] mg vs. 15.0 [ 10.0-17 .5 ] mg , p = 0.248 ) .
RESULTS	Arterial pressure and sedation intensity reduced similarly overtime with both drugs .
RESULTS	Cost of sedation was lower for diazepam than for midazolam ( 1.4 [ 1.4-1 .8 ] vs. 13.9 [ 9.4-16 .2 ] reais , p < 0.001 ) .
CONCLUSIONS	intubation using intravenous diazepam and midazolam is effective and well tolerated .
CONCLUSIONS	Sedation with diazepam is associated to a quicker sedation time and to lower costs .

###25958473
OBJECTIVE	Intramyocardial bone marrow mononuclear cells ( BMMNC ) implantation concomitant to coronary artery bypass grafting ( CABG ) surgery as an option for regenerative therapy in chronic ischemic heart failure was tested in a very few number of studies , with not consistent conclusions regarding improvement in left ventricular function , and with a follow-up period between 6 months and 1 year .
OBJECTIVE	This study was focused on testing of the hypothesis that intramyocardial BMMNC implantation , concomitant to CABG surgery in ischemic cardiomyopathy patients , leads to better postoperative long-term results regarding the primary end-point of conditional status-functional capacity and the secondary endpoint of mortality than CABG surgery alone in a median follow-up period of 5 years .
METHODS	A total of 30 patients with ischemic cardiomyopathy and the median left venticular ejection fraction ( LVEF ) of 35.9 4.7 % were prospectively and randomly enrolled in a single center interventional , open labeled clinical trial as two groups : group I of 15 patients designated as the study group to receive CABG surgery and intramyocardial implantation of BMMNC and group II of 15 patients as the control group to receive only the CABG procedure .
METHODS	All the patients in both groups received the average of 3.4 0.7 implanted coronary grafts , and all of them received the left internal mammary artery ( LIMA ) to the left anterior descending ( LAD ) and autovenous to other coronaries .
RESULTS	The group with BMMNC and CABG had the average of 17.5 3.8 injections of BMMNC suspension with the average number of injected bone marrow mononuclear cells of 70.7 32.4 x 10 ( 6 ) in the total average volume of 5.7 1.5 mL .
RESULTS	In this volume the average count of CD34 + and CD133 + cells was 3.96 2.77 x 10 ( 6 ) and 2.65 1.71 x 10 ( 6 ) , respectively .
RESULTS	All the patients were followed up in 2.5 to 7.5 years ( median , 5 years ) .
RESULTS	At the end of the follow-up period , siginificantly more patients from the group that received BMMNC were in the functional class I compared to the CABG only group ( 14/15 vs 5/15 ; p = 0.002 ) .
RESULTS	After 6 months the results on 6-minute walk test ( 6-MWT ) were significantly different between the groups ( 435 m in the BMMNC and CABG group and 315 m in the CABG only group ; p = 0.001 ) , and continued to be preserved and improved on the final follow-up ( 520 m in the BMMNC and CABG group vs 343 m in the CABG only group ; p < 0.001 ) .
RESULTS	Cardiovascular mortality was also significantly reduced in the BMMNC and CABG group ( p = 0.049 ) .
CONCLUSIONS	Implanatation of BMMNC concomitant to CABG is a safe and feasible procedure that demonstates not only the improved functional capacity but also a reduced cardiac mortality in a 5-year follow-up in patients with ischemic cardiomyopathy scheduled for CABG surgery .

###25403645
BACKGROUND	The oral factor Xa inhibitor edoxaban has demonstrated safety and efficacy in stroke prevention in patients with atrial fibrillation and in the treatment and secondary prevention of venous thromboembolism .
BACKGROUND	This study investigated the reversal of edoxaban 's effects on bleeding measures and biomarkers by using a 4-factor prothrombin complex concentrate ( 4F-PCC ) .
RESULTS	This was a phase 1 study conducted at a single site .
RESULTS	This was a double-blind , randomized , placebo-controlled , 2-way crossover study to determine the reversal effect of descending doses of 4F-PCC on bleeding duration and bleeding volume following edoxaban treatment .
RESULTS	A total of 110 subjects ( 17 in part 1 , 93 in part 2 ) were treated .
RESULTS	Intravenous administration of 4F-PCC 50 , 25 , or 10 IU/kg following administration of edoxaban ( 60 mg ) dose-dependently reversed edoxaban 's effects on bleeding duration and endogenous thrombin potential , with complete reversal at 50 IU/kg .
RESULTS	Effects on prothrombin time were partially reversed at 50 IU/kg .
RESULTS	A similar trend was seen for bleeding volume .
CONCLUSIONS	The 4F-PCC dose-dependently reversed the effects of edoxaban ( 60 mg ) , with complete reversal of bleeding duration and endogenous thrombin potential and partial reversal of prothrombin time following 50 IU/kg .
CONCLUSIONS	Edoxaban alone and in combination with 4F-PCC was safe and well tolerated in these healthy subjects .
CONCLUSIONS	A dose of 50 IU/kg 4F-PCC may be suitable for reversing edoxaban anticoagulation .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT02047565 .

###26014295
OBJECTIVE	The NCIC CTG PR3/MRC PR07 randomized phase III trial compared androgen-deprivation therapy ( ADT ) alone versus ADT with radiotherapy ( RT ) for patients with locally advanced prostate cancer .
OBJECTIVE	This article reports the health-related quality-of-life ( HRQOL ) outcomes of this trial .
METHODS	A total of 1,205 patients were randomly allocated to either ADT alone or ADT with RT. .
METHODS	HRQOL was assessed at baseline and every 6 months thereafter using the European Organisation for Research and Treatment of Cancer Core Questionnaire and a prostate cancer-specific checklist or the Functional Assessment of Cancer Therapy-Prostate questionnaire .
METHODS	Mean changes from baseline scores for five function domains and nine symptom domains were analyzed as those most relevant to ADT and RT. .
METHODS	The proportions of patients with improved , stable , or worsened HRQOL scores according to instrument-specific minimal important differences were calculated .
RESULTS	Baseline questionnaires were completed by 1,028 patients ( 88 % ) .
RESULTS	At 6 months , RT had a statistically significant impact on mean score for bowel symptoms ( P = .02 ) , diarrhea ( P < .001 ) , urinary function ( P = .003 ) , and erectile dysfunction ( P = .008 ) ; by 3 years , however , there were no significant between-group differences in any domain .
RESULTS	Generalized linear mixed modeling revealed no significant between-arm differences in any of the function scales but showed significant deterioration in both arms over time for Functional Assessment of Cancer Therapy-Prostate total score , treatment outcome index , and physical and functional well-being .
CONCLUSIONS	The addition of RT to ADT for patients with locally advanced prostate cancer significantly improved overall survival and had only modest and transient negative impact on relevant domains of HRQOL .

###24274128
BACKGROUND	To evaluate the effectiveness of a capacity-building intervention administered through a primary health care ( PHC ) system on community disaster preparedness in Iran .
METHODS	A controlled community intervention trial with pre - and postassessments was conducted in 2011 in 3 provinces of Iran .
METHODS	In each province , 2 areas were chosen and randomly selected as an intervention or control group .
METHODS	A total of 9200 households were in the intervention area and 10 010 were in the control area .
METHODS	In each study group in each province 250 households were sampled for pre - and postassessment surveys .
METHODS	Community health volunteers led by PHC staff administered an educational intervention covering elements of hazard awareness and preparedness , with a focus on earthquakes and floods .
METHODS	Relative changes for awareness and readiness scores were assessed to demonstrate changes in outcome variables from pre - to postassessments in intervention and control groups .
METHODS	An effectiveness test of significance was based on interaction between time and area .
RESULTS	Households in intervention communities exhibited improved disaster awareness and readiness with respect to all outcome measures .
RESULTS	Relative changes in awareness in intervention and control areas were 2.94 and -0.08 , respectively ( P < .001 ) .
RESULTS	Relative changes for readiness scores were 5.52 in intervention areas and 0.56 in control areas ( P < .001 ) .
RESULTS	Relative changes for awareness and readiness were significantly correlated with a community 's baseline risk perception and previous experience with natural disasters ( P < .001 ) .
CONCLUSIONS	An educational intervention administered through the PHC system effectively improved disaster awareness and readiness at a community level .
CONCLUSIONS	For sustainability , community disaster reduction programs must be integrated into routine public health service delivery .

###26419096
BACKGROUND	Preoperative oral rehydration solution ( ORS ) prevents dehydration before surgery .
BACKGROUND	Therefore taking enough ORS possibly reduces the hemodynamic changes during induction of anesthesia , and reduces the amount of fluid needed during anesthesia .
METHODS	Forty patients undergoing elective surgery were randomly assigned to two groups : drinking 1,500 ml ORS 6 to 2 hours before anesthesia ( ORS group ) and nothing by mouth from 6 hours before anesthesia ( Control group ) .
METHODS	Anesthesia induction was performed using propofol and remifentanil .
METHODS	To evaluate the hemodynamic changes , hemodynamic parameters including heart rate , blood pressure , cardiac index ( CI ) , and stroke volume variation ( SVV ) were recorded before induction , after propofol administration , and after remifentanil administration .
METHODS	Total urine volume and the amount of fluid were also recorded at the end of the anesthesia .
RESULTS	In ORS group , CI showed a significantly higher value after propofol administration ( P = 0.046 ) .
RESULTS	SVV was significantly lower ( P < 0.0001 ) and total amount of fluid during anesthesia was significantly reduced ( P < 0.0001 ) in ORS group .
CONCLUSIONS	Preoperative oral rehydration increases circulating blood volume , it keeps high CI during induction of anesthesia , and reduces the amount of intraoperative fluid .

###24268034
BACKGROUND	Perioperative prophylactic antibiotic treatment significantly influences intestinal microflora , resulting in impaired bowel functioning in some patients , sometimes requiring further investigations .
BACKGROUND	This may lead to a worse health-related quality of life ( HRQoL ) .
BACKGROUND	Probiotics administrated in the early post-operative period may help avoiding such nuisances in older people .
METHODS	We prospectively enrolled patients undergoing laparoscopic colorectal surgery aged over 70 years between 2005 and 2012 .
METHODS	The study was approved by IRB .
METHODS	All patients received perioperative antibiotic treatment .
METHODS	Patients were randomized to one of two treatment arms : Group A patients received probiotics after surgery ( VSL # 3 , VSL Pharmaceuticals , Inc. .
METHODS	USA - 900 109 daily , while Group B patients received a Placebo ( cornstarch ) .
METHODS	Patients were further divided in sub-groups whether ileo-caecal valve was spared or not .
METHODS	Patients were followed-up every 7 days for 4 weeks .
METHODS	Patients daily annotated bowel frequency , stool shape and consistency - according to Bristol 's scale .
METHODS	HRQoL was assessed every week by means of SF-36 questionnaire .
RESULTS	Group A included 10 while Group B included 8 patients .
RESULTS	One patient in each group experienced a postoperative complication .
RESULTS	Group A patients had fewer bowel movements than controls , during every week .
RESULTS	Stool consistency was higher in patients undergoing resections including ileo-caecal valve receiving VSL # 3 .
RESULTS	HRQoL gradually increased in both groups ; Group A patients had higher `` social functioning '' item scores at week 1 and 4 than controls .
CONCLUSIONS	Elderly patients undergoing resection of ileo-caecal valve may benefit from an early probiotics administration pathway after perioperative antibiotic treatment .

###25516885
OBJECTIVE	To evaluate the 10-year durability of a nanohybrid resin composite in Class II restorations in a randomized controlled intraindividual comparison with its conventional hybrid resin composite predecessor .
METHODS	Each of 52 participants received at least two Class II restorations that were as similar as possible .
METHODS	The cavities were chosen at random to be restored with a nanohybrid resin composite ( Excite/Tetric EvoCeram ( TEC ) ; n = 61 ) and a conventional hybrid ( Excite/Tetric Ceram ( TC ) ; n = 61 ) .
METHODS	The restorations were evaluated with slightly modified USPHS criteria at baseline and then annually for 10 years .
METHODS	The overall performance of the experimental restorations was tested after intra-individual comparison and their ranking was tested using Friedman 's two-way ANOVA .
METHODS	The level of significance was set at 5 % .
RESULTS	Four patient drop-outs with 8 restorations ( 4TEC , 4TC ) were registered during the follow-up .
RESULTS	A prediction of the caries risk showed that 16 of the evaluated 52 patients were considered as high risk patients .
RESULTS	In total , 22 restorations , 11 TEC ( 3 premolars , 8 molars ) and 11 TC ( 3 premolars , 8 molars ) restorations failed during the 10 years .
RESULTS	The main reason for failure was secondary caries ( 50 % ) .
RESULTS	63 % of the recurrent caries lesions were found in high caries risk participants .
RESULTS	The overall success rate at 10 years was 80.7 % , with an annual failure rate of 1.9 % .
RESULTS	No statistically significant difference was found in the overall survival rate between the two investigated resin composites .
CONCLUSIONS	The nanohybrid and the conventional hybrid resin composite showed good clinical effectiveness in extensive Class II restorations during the 10-year study .

###24679444
OBJECTIVE	To evaluate the efficacy and safety of intravitreal aflibercept injection ( IAI ) for the treatment of macular edema secondary to central retinal vein occlusion ( CRVO ) .
METHODS	Randomized , double-masked , phase 3 trial .
METHODS	A total of 188 patients with macular edema secondary to CRVO .
METHODS	Patients received IAI 2 mg ( IAI 2Q4 ) ( n = 114 ) or sham injections ( n = 74 ) every 4 weeks up to week 24 .
METHODS	During weeks 24 to 52 , patients from both arms were evaluated monthly and received IAI as needed , or pro re nata ( PRN ) ( IAI 2Q4 + PRN and sham + IAI PRN ) .
METHODS	During weeks 52 to 100 , patients were evaluated at least quarterly and received IAI PRN .
METHODS	The primary efficacy end point was the proportion of patients who gained 15 letters in best-corrected visual acuity ( BCVA ) from baseline to week 24 .
METHODS	This study reports week 100 results .
RESULTS	The proportion of patients gaining 15 letters was 56.1 % versus 12.3 % ( P < 0.001 ) at week 24 , 55.3 % versus 30.1 % ( P < 0.001 ) at week 52 , and 49.1 % versus 23.3 % ( P < 0.001 ) at week 100 in the IAI 2Q4 + PRN and sham + IAI PRN groups , respectively .
RESULTS	The mean change from baseline BCVA was also significantly higher in the IAI 2Q4 + PRN group compared with the sham + IAI PRN group at week 24 ( +17.3 vs. -4.0 letters ; P < 0.001 ) , week 52 ( +16.2 vs. +3.8 letters ; P < 0.001 ) , and week 100 ( +13.0 vs. +1.5 letters ; P < 0.0001 ) .
RESULTS	The mean reduction from baseline in central retinal thickness was 457.2 versus 144.8 m ( P < 0.001 ) at week 24 , 413.0 versus 381.8 m at week 52 ( P = 0.546 ) , and 390.0 versus 343.3 m at week 100 ( P = 0.366 ) in the IAI 2Q4 + PRN and sham + IAI PRN groups , respectively .
RESULTS	The mean number ( standard deviation ) of PRN injections in the IAI 2Q4 + PRN and sham + IAI PRN groups was 2.7 1.7 versus 3.9 2.0 during weeks 24 to 52 and 3.3 2.1 versus 2.9 2.0 during weeks 52 to 100 , respectively .
RESULTS	The most frequent ocular serious adverse event from baseline to week 100 was vitreous hemorrhage ( 0.9 % vs. 6.8 % in the IAI 2Q4 + PRN and sham + IAI PRN groups , respectively ) .
CONCLUSIONS	The visual and anatomic improvements after fixed dosing through week 24 and PRN dosing with monthly monitoring from weeks 24 to 52 were diminished after continued PRN dosing , with a reduced monitoring frequency from weeks 52 to 100 .

###24428805
BACKGROUND	Environmental enteropathy ( EE ) is an asymptomatic abnormality of small bowel structure and function , which may underlie vaccine inefficacy in the developing world .
BACKGROUND	HIV infection co-exists in many of these populations .
BACKGROUND	There is currently no effective treatment .
BACKGROUND	We conducted a secondary analysis of a randomised controlled trial of high dose multiple micronutrient ( MM ) supplementation on small bowel architecture in EE in participants with or without HIV infection .
METHODS	In a double-blind parallel-group trial of the effect of MM on innate immune responses to oral vaccines , consenting Zambian adults were randomised to receive 6 weeks of 24 micronutrients as a daily capsule or placebo .
METHODS	HIV status was established after randomisation .
METHODS	Proximal jejunal biopsies were obtained after the supplementation period .
METHODS	Villous height , crypt depth , villous width , villous perimeter per 100 m muscularis mucosa ( a measure of epithelial surface area ) , and villous cross sectional area per 100 m muscularis mucosa ( a measure of villous compartment volume ) were measured in orientated biopsy sections using semi-automated image analysis .
METHODS	Analysis was by intention to treat .
RESULTS	18 patients received MM and 20 placebo .
RESULTS	6/18 MM and 9/20 placebo patients had HIV .
RESULTS	In HIV negative patients given MM compared to placebo , mean villous height was 24.0 % greater ( 293.3 v. 236.6 m ; 95 % CI of difference 17.7-95 .9 m ; P = 0.006 ) , mean villous area was 27.6 % greater ( 27623 v. 21650 m2/100 m ; 95 % CI of difference 818-11130 m2/100 m ; P = 0.03 ) , and median villous perimeter was 29.7 % greater ( 355.0 v. 273.7 m/100 m ; 95 % CI of difference 16.3-146 .2 m/100 m ; P = 0.003 ) .
RESULTS	There was no significant effect on crypt depth or villous width .
RESULTS	No effect was observed in HIV positive patients .
RESULTS	There were no adverse events attributable to MM .
CONCLUSIONS	MM improved small bowel villous height and absorptive area , but not crypt depth , in adults with EE without HIV .
CONCLUSIONS	Nutritional intervention may therefore selectively influence villous compartment remodelling .
CONCLUSIONS	In this small study , there was a clear difference in response depending on HIV status , suggesting that EE with superimposed HIV enteropathy may be a distinct pathophysiological condition .

###24506332
OBJECTIVE	To test the hypothesis that racial biases in opioid prescribing would be more likely under high levels of cognitive load , defined as the amount of mental activity imposed on working memory , which may come from environmental factors such as stressful conditions , chaotic workplace , staffing insufficiency , and competing demands , one 's own psychological or physiological state , as well as from demands inherent in the task at hand .
METHODS	Two ( patient race : White vs Black ) by two ( cognitive load : low vs high ) between-subjects factorial design .
METHODS	Ninety-eight primary care physicians from the Veterans Affairs Healthcare System .
METHODS	Web-based experimental study .
METHODS	Physicians were randomly assigned to read vignettes about either a Black or White patient , under low vs high cognitive load , and to indicate their likelihood of prescribing opioids .
METHODS	High cognitive load was induced by having physicians perform a concurrent task under time pressure .
RESULTS	There was a three-way interaction between patient race , cognitive load , and physician gender on prescribing decisions ( P = 0.034 ) .
RESULTS	Hypotheses were partially confirmed .
RESULTS	Male physicians were less likely to prescribe opioids for Black than White patients under high cognitive load ( 12.5 % vs 30.0 % ) and were more likely to prescribe opioids for Black than White patients under low cognitive load ( 30.8 % vs 10.5 % ) .
RESULTS	By contrast , female physicians were more likely to prescribe opioids for Black than White patients in both conditions , with greater racial differences under high ( 39.1 % vs 15.8 % ) vs low cognitive load ( 28.6 % vs 21.7 % ) .
CONCLUSIONS	Physician gender affected the way in which patient race and cognitive load influenced decisions to prescribe opioids for chronic pain .
CONCLUSIONS	Future research is needed to further explore the potential effects of physician gender on racial biases in pain treatment , and the effects of physician cognitive load on pain treatment .

###25699348
OBJECTIVE	Carbon dioxide ( CO2 ) insufflation has been used in endoscopic retrograde cholangiopancreatography ( ERCP ) .
OBJECTIVE	However , its usefulness and safety are controversial in elderly patients .
OBJECTIVE	Our aim was to assess the safety and usefulness of CO2 insufflation during ERCP in elderly patients .
METHODS	Between April 2010 and June 2011 , a total of 60 patients 75 years old or older , who underwent ERCP , were randomized into the CO2 group ( n = 30 ) and the air group ( n = 30 ) .
METHODS	Main outcomes were determined by assessing abdominal symptoms according to the Wong-Baker FACES Pain Rating Scale , calculating the volume of residual gas retention within the intestines on abdominal X-ray quantitatively and observing the cardiopulmonary states .
RESULTS	30 patients in the CO2 group and 30 patients in the air group were analyzed .
RESULTS	Abdominal distension ( P < 0.01 ) , discomfort ( P < 0.01 ) and nausea ( P < 0.01 ) at 2 hours after ERCP were significantly reduced in the CO2 group .
RESULTS	The gas volume scores immediately after ERCP ( P < 0.01 ) and at 2 hours ( P < 0.01 ) were significantly lower in the CO2 group .
CONCLUSIONS	CO2 insufflation instead of air insufflation is safe and useful for the prevention of post-ERCP abdominal symptoms in elderly patients .

###24382705
OBJECTIVE	For ethnic minority families , the bridging of clinician-client differences is essential to their engagement in treatment .
OBJECTIVE	The Culturally Enhanced Video Feedback Engagement ( CEVE ) intervention aims to enhance client engagement through fostering clinician-client shared cultural understanding .
OBJECTIVE	The present study tested the effectiveness of the CEVE on client-rated clinician cultural competence and therapeutic alliance .
METHODS	Nineteen ethnic minority families with children aged 3-6 years were randomized to the CEVE ( n = 9 ) or treatment as usual ( n = 10 ) at an outpatient clinic .
RESULTS	Results from linear mixed effects regression models indicated a significant effect of the CEVE on intercept , suggesting that clinician cultural competence and therapeutic alliance were significantly higher in the CEVE condition .
RESULTS	No effect was found for clinician growth in skills .
CONCLUSIONS	The results indicate that the CEVE enhances client treatment engagement via clinician cultural competence and clinician-client alliance , suggesting its promise as a clinical engagement tool , particularly for treatments serving ethnic minority families .

###24886392
BACKGROUND	Antenatal care ( ANC ) reduces maternal and perinatal morbidity and mortality directly through the detection and treatment of pregnancy-related illnesses , and indirectly through the detection of women at increased risk of delivery complications .
BACKGROUND	The potential benefits of quality antenatal care services are most significant in low-resource countries where morbidity and mortality levels among women of reproductive age and neonates are higher.WHO developed an ANC model that recommended the delivery of services scientifically proven to improve maternal , perinatal and neonatal outcomes .
BACKGROUND	The aim of this study is to determine the effect of an intervention designed to increase the use of the package of evidence-based services included in the WHO ANC model in Mozambique .
BACKGROUND	The primary hypothesis is that the intervention will increase the use of evidence-based practices during ANC visits in comparison to the standard dissemination channels currently used in the country .
METHODS	This is a demonstration project to be developed through a facility-based cluster randomized controlled trial with a stepped wedge design .
METHODS	The intervention was tailored , based on formative research findings , to be readily applicable to local prenatal care services and acceptable to local pregnant women and health providers .
METHODS	The intervention includes four components : the provision of kits with all necessary medicines and laboratory supplies for ANC ( medical and non-medical equipment ) , a storage system , a tracking system , and training sessions for health care providers .
METHODS	Ten clinics were selected and will start receiving the intervention in a random order .
METHODS	Outcomes will be computed at each time point when a new clinic starts the intervention .
METHODS	The primary outcomes are the delivery of selected health care practices to women attending the first ANC visit , and secondary outcomes are the delivery of selected health care practices to women attending second and higher ANC visits as well as the attitude of midwives in relation to adopting the practices .
METHODS	This demonstration project is pragmatic in orientation and will be conducted under routine conditions .
CONCLUSIONS	There is an urgent need for effective and sustainable scaling-up approaches of health interventions in low-resource countries .
CONCLUSIONS	This can only be accomplished by the engagement of the country 's health stakeholders at all levels .
CONCLUSIONS	This project aims to achieve improvement in the quality of antenatal care in Mozambique through the implementation of a multifaceted intervention on three levels : policy , organizational and health care delivery levels .
CONCLUSIONS	The implementation of the trial will probably require a change in accountability and behaviour of health care providers and we expect this change in ` habits ' will contribute to obtaining reliable health indicators , not only related to research issues , but also to health care outcomes derived from the new health care model .
CONCLUSIONS	At policy level , the results of this study may suggest a need for revision of the supply chain management system .
CONCLUSIONS	Given that supply chain management is a major challenge for many low-resource countries , we envisage that important lessons on how to improve the supply chain in Mozambique and other similar settings , will be drawn from this study .
BACKGROUND	Pan African Clinical Trial Registry database .
BACKGROUND	Identification number : PACTR201306000550192 .

###25037651
BACKGROUND	The number of older adults using wheelchairs in nursing homes is over 50 % of that population , and many of them use wheelchairs due to muscle weakness in the lower extremities .
BACKGROUND	Muscles of older adults are trainable , and progressive resistance exercises using elastic bands can increase muscle strength in older adults .
OBJECTIVE	To test the effectiveness of six-month Wheelchair-bound Senior Elastic Band exercises on the functional fitness of older adults in nursing homes .
METHODS	Cluster randomized trial .
METHODS	Ten nursing homes , southern Taiwan .
METHODS	127 participants were recruited , and 114 of them completed the study .
METHODS	Inclusion criteria were : ( 1 ) aged 65 and over , ( 2 ) using wheelchairs for mobility , ( 3 ) living in the facility for at least three months , ( 4 ) cognitively intact , and ( 5 ) heavily or moderate dependency in their activities of daily living .
METHODS	The mean age of the participants was 79.15 ( 7.03 ) years , and 98.20 % of them had chronic illnesses .
METHODS	Participants were randomly assigned to the experimental ( five nursing homes , n = 59 ) or the control ( five nursing homes , n = 55 ) group based on the nursing homes where they stayed .
METHODS	A 40-min Wheelchair-bound Senior Elastic Band exercise program was implemented three times per week for six months for the experimental group participants .
METHODS	The functional fitness ( activities of daily living , lung capacity , body flexibilities , muscle power and endurance ) of the participants was examined at baseline , after three months , and at the end of the six months study .
METHODS	The mixed-design , two-way analysis of variance was used to detect the interaction effects , and one-way repeated measures analysis of variance and analysis of covariance were performed to analyze the within-group and between-group differences .
RESULTS	At the end of the six-month study , the Wheelchair-bound Senior Elastic Band group had better performances in all of the functional fitness indicators than the control group ( all p < 0.05 ) .
CONCLUSIONS	The Wheelchair-bound Senior Elastic Band exercises significantly improved the functional fitness of the older adults in wheelchairs .
CONCLUSIONS	It is suggested that the program be incorporated as a part of daily activities for nursing home older adults in wheelchairs .

###25868737
OBJECTIVE	To provide a new surgical technique for epididymal cyst ( EC ) treatment and to assess its safety and efficiency .
METHODS	Forty-eight patients with symptomatic EC were randomized into 2 groups .
METHODS	One group ( n = 23 ) received traditional open epididymal cystectomy ( OEC ) and the other group ( n = 25 ) underwent minimal epididymal cystectomy with scrotoscope ( MECS ) , which provided a clear vision of scrotal contents .
METHODS	Demographic information and perioperative and postoperative outcomes data were obtained and analyzed during a 2 - to 6-month follow-up .
RESULTS	No significant differences between the OEC and MECS groups were found in demographic information .
RESULTS	Compared with OEC group , the MECS group had a shorter operating time ( 18.6 2.9 vs 54.5 7.0 minutes ; P < .05 ) , shorter incision length ( 1.1 0.2 vs 4.8 0.6 cm ; P < .05 ) , and less blood loss ( 4.6 1.6 vs 17.0 3.1 g ; P < .05 ) .
RESULTS	Except for the 8.0 % rate ( 2 of 25 ) of scrotal edema after MECS and 17.4 % rate ( 4 of 23 ) of scrotal hematoma after OEC , both groups resulted in 0 % incidence of testis or epididymis injury , wound infection , and cyst recurrence based on postoperative outcome data .
RESULTS	Significant differences were observed after MECS compared with those after OEC based on the rates of symptom relief ( 95.2 % vs 61.1 % ; P < .05 ) and days of wound pain ( 12.1 2.6 vs 17.7 4.1 days ; P < .05 ) .
CONCLUSIONS	For the first time , our study applied scrotoscope as a new alternative technique for EC treatment .
CONCLUSIONS	Scrotoscope provides a clear field of vision and makes tissues harvested available for pathologic examination when performing decortications of EC .
CONCLUSIONS	The results suggest MECS may be a safe , effective , and encouraging new technique .

###24759301
OBJECTIVE	This study was conducted to examine the effects of weight reduction on proteinuria , adipokines , and renal function in overweight immunoglobulin A nephropathy ( IgAN ) patients ( body mass index > 23 kg/m2 ) with chronic proteinuria more than 6 months .
METHODS	This was a single-center , prospective , randomized controlled trial .
METHODS	The study was performed at the outpatient clinic at King Chulalongkorn Memorial Hospital , Bangkok , Thailand , from July 2012 to February 2013 .
METHODS	Twenty-six overweight patients with chronic proteinuric biopsy-proven IgAN were randomized into a control group ( n = 13 ) or a low-calorie normal protein diet group ( n = 13 ) .
METHODS	All patients received the maximum dosage of angiotensin-converting enzyme inhibitor or angiotensin receptor blocker and other antihypertensive agents to achieve a blood pressure less than 125/75 mmHg .
METHODS	The study intervention was a low-calorie diet ( target energy per day as 500-kcal subtraction from total energy requirement ) for a 6-month period .
METHODS	At baseline and after 6 months of a low-calorie diet , body weight , body content , and clinical and laboratory parameters were determined and compared .
RESULTS	After initiating a low-calorie diet for 6 months , the normalized protein nitrogen appearance values were not different , indicating comparable protein intake .
RESULTS	The low-calorie group had lower total daily calorie intake ( 1,307.1 171.8 vs. 1,772.2 315.4 kcal/d , P < .01 ) and significant reductions in body weight ( -5.1 3.3 % , P < .001 ) , fat content ( -12.7 14.1 % , P < .05 ) , and 24-hour urine protein ( -45.2 15.4 % , P < .001 ) .
RESULTS	Blood pressure and renal function parameters were unaltered .
RESULTS	The low-calorie group had approximately 20 % lower plasma levels of leptin but unchanged adiponectin .
RESULTS	There were positive correlations between the amount of protein reduction and the changes of body weight , fat mass , and leptin .
CONCLUSIONS	A 6-month low-calorie diet leads to weight reduction and results in diminished fat content and decreased proteinuria in overweight IgAN patients with chronic proteinuria .
CONCLUSIONS	This beneficial effect might be mediated by changes in adipokines .

###24228862
BACKGROUND	This study provides insight into the long-term efficacy ( i.e. 12 month results ) of the Web-based or print-delivered tailored Active Plus intervention ( with and without environmental approach ) to promote physical activity ( PA ) among the over-fifties .
BACKGROUND	Differences in effect among subgroups are studied as well .
METHODS	Intervention groups ( i.e. print-delivered basic ( PB ; N = 439 ) , print-delivered environmental ( PE ; N = 435 ) , Web-based basic ( WB ; N = 423 ) , Web-based environmental ( WE ; N = 432 ) ) and a waiting list control group ( N = 411 ) were studied in a clustered randomized controlled trial .
METHODS	Intervention participants received tailored advice three times within 4 months .
METHODS	Long-term effects ( 12 months after the intervention has started , i.e. 8 months after the intervention was completed ) on PA ( i.e. self-reported weekly minutes and days of sufficient PA ) were tested using multilevel linear regression analyses .
METHODS	Participants ' age , gender , BMI , educational level , PA intention and the presence of a chronic physical limitation were considered to be potential moderators of the effect .
RESULTS	Overall , the Active Plus intervention was effective in increasing weekly days of sufficient PA ( B = 0.49 ; p = .005 ) , but ineffective in increasing weekly minutes of PA ( B = 84.59 ; p = .071 ) .
RESULTS	Per intervention condition analysis showed that the PB-intervention ( B ( days ) = 0.64 ; p = .002 ; B ( min ) = 111.36 ; p = .017 ) and the PE-intervention ( B ( days ) = 0.70 ; p = .001 ; B ( min ) = 157.41 ; p = .001 ) were effective in increasing days and minutes of PA. .
RESULTS	Neither Web-based conditions significantly increased PA , while the control group decreased their PA. .
RESULTS	In contrast to the intervention effect on minutes of PA , the effect on weekly days of PA was significantly moderated by the participants ' baseline intention to be sufficiently physically active .
CONCLUSIONS	In general , after 12 months the print-delivered interventions resulted in stronger effects than the Web-based interventions .
CONCLUSIONS	The participants ' baseline intention was the only significant moderator of the intervention effect .
CONCLUSIONS	All other assessed user characteristics did not significantly moderate the effect of the intervention , which might indicate that the intervention is sufficiently tailored to the different participant characteristics .
CONCLUSIONS	Additional efforts should be taken to increase the sustainability of Web-based interventions .
BACKGROUND	Dutch Trial Register : NTR2297 .

###25241089
OBJECTIVE	The aim of this study was to evaluate the efficacy of Mycobacterium w ( Mw ) , an immunomodulator in severe sepsis .
METHODS	Patients 18 years or older with severe sepsis were randomized within 48 hours of first organ dysfunction to receive either intradermal Mw or saline .
METHODS	The primary end point was 28-day mortality , whereas the secondary end points were ventilator days , intensive care unit ( ICU ) and hospital length of stay , and delta Sequential Organ Failure Assessment ( SOFA ) score .
RESULTS	Fifty patients with severe sepsis ( 25 Mw , 25 control ) were included in the study .
RESULTS	There were 7 and 8 deaths in the Mw and control groups , respectively ( P = 0.51 ) .
RESULTS	The days on mechanical ventilator were significantly lesser in the Mw group compared with control ( median , 6 vs 9 ; P = 0.025 ) .
RESULTS	The median ICU and hospital length of stay was significantly less in the Mw arm ( 7 vs 12 days [ P = 0.006 ] and 10 vs 16 [ P = 0.007 ] , respectively ) .
RESULTS	The delta SOFA score was significantly higher in the control arm ( P = 0.027 ) .
RESULTS	There was a higher incidence of secondary bacterial infections in the control group ( P = 0.009 ) .
CONCLUSIONS	The use of Mw in severe sepsis was associated with significant reduction in days on mechanical ventilation , ICU and hospital length of stay , lower incidence of nosocomial infection , and delta SOFA score .

###24331802
OBJECTIVE	To investigate the clinical efficacy of noninvasive positive pressure ventilation ( NPPV ) in treatment of patients with arrhythmia complicated by sleep apnea syndrome ( SAS ) .
METHODS	One hundred and thirty-five arrhythmia patients with polysomnography diagnosed SAS were randomly divided into NPPV group ( 69 cases ) and control group ( 66 cases ) , the NPPV group was treated with standard medications and NPPV , and the control group was treated with standard medications .
METHODS	SAS related parameters were compared between the groups after 3 months therapy .
RESULTS	( 1 ) Epworth sleepiness scale ( ESS ) score , apnea-hypopnea index ( AHI ) and arousal index were significantly lower ( 8.25 5.41 vs. 4.08 3.43 , 39.95 7.32 vs. 4.71 1.80 and 39.69 4.40 vs. 15.20 2.05 , P < 0.01 ) while not rapid eye movement ( NREM ) III and rapid eye movement stage of sleep time and lowest pulse oxygen saturation ( LSaO2 ) were significantly higher in NPPV group than in control group [ ( 4.53 2.10 ) % vs. ( 16.78 2.59 ) % , ( 8.37 1.380 ) % vs. ( 15.25 1.41 ) % , ( 77.15 6.72 ) % vs. ( 93.35 2.03 ) % , P < 0.01 ] after 3 months therapy .
RESULTS	( 2 ) Incidence of Sinus bradycardia , sinus tachycardia , sinus arrest , atrial premature beats , ventricular premature beats , paroxysmal atrial tachycardia , paroxysmal ventricular tachycardia , atrial fibrillation , II-III degree atrioventricular block , ST-T segment changes were reduced from 57.4 % , 44.4 % , 7.4 % , 20.4 % , 13.0 % , 36.5 % , 12.0 % , 8.3 % , 37.0 % , 53.7 % to 4.6 % , 1.9 % ,0.0 % , 3.7 % , 2.8 % , 7.0 % , 0.9 % , 0.0 % , 1.9 % , 4.6 % ( all P < 0.05 ) and the total number of arrhythmias happened at night were significantly lower ( all P < 0.05 ) while the heart rate variability ( HRV ) were significantly higher ( P < 0.01 ) in NPPV group than in control group ; AHI was positively while LSaO2 was negatively correlated with the total night arrhythmia number ( P < 0.01 ) .
CONCLUSIONS	Noninvasive positive pressure ventilation is an effective therapy strategy for treating patients with arrhythmia complicated by sleep apnea syndrome .

###24237190
BACKGROUND	Premenstrual dysphoric disorder ( PMDD ) afflicts ~ 7 % of reproductive-age women resulting in impaired relationships , diminished overall quality of life , and disability-adjusted life years lost on par with other major psychiatric disorders .
BACKGROUND	Response to pharmacological treatment is inadequate in ~ 50 % of women with PMDD .
OBJECTIVE	The goal of the present study is to evaluate the effects of a novel approach-short-term chromium supplementation-on menstrual cycle-related mood and physical symptoms .
METHODS	Five women were studied under single-blind conditions in a private clinical setting ( 2 of them were referred specifically for treatment-resistant menstrual-related symptoms ) ; 6 women completed a double-blind crossover study of chromium plus placebo versus chromium plus sertraline in a university clinical research setting .
METHODS	Treatments were administered from mid-cycle to onset of menses in 1-month intervals .
METHODS	Symptom ratings were obtained by self-report , using daily symptom checklists , and by clinical assessment , using the Hamilton Psychiatric Rating Scale for Depression ( HAM-D ) and the Clinical Global Impressions ( CGI ) scale .
RESULTS	Overall , chromium treatment was associated with reduced mood symptoms and improved overall health satisfaction in most participants .
RESULTS	In some cases , chromium alone was associated with marked clinical improvement ; in others , chromium plus an antidepressant resulted in greater improvement than either chromium alone or an antidepressant alone .
CONCLUSIONS	These preliminary observations suggest that chromium may be a useful monotherapy or adjunctive therapy for women suffering from significant menstrual cycle-related symptoms .
CONCLUSIONS	Larger , controlled studies are needed to evaluate the efficacy of chromium treatment in this patient population .

###25929531
BACKGROUND	Low back pain ( LBP ) is an important health problem in all developed countries and is associated with high levels of disability .
BACKGROUND	Evidence-based clinical practice guidelines usually recommend different physical therapy interventions to manage this condition .
BACKGROUND	However , those interventions usually result in small to moderate clinical effects .
BACKGROUND	Recent studies suggest that interventions based on subgroup classifications may improve the effect sizes compared with rehabilitation programs where the same interventions were applied to all patients .
OBJECTIVE	This study will investigate the efficacy of treatment based on a Movement System Impairment ( MSI ) - based classification model for patients with chronic LBP compared with general exercise .
OBJECTIVE	The primary outcomes will be pain intensity and disability at 2 months after randomization .
METHODS	The study is a 2-arm , prospectively registered , randomized controlled trial with a blinded assessor .
METHODS	The study setting will be a university physical therapy clinic in Brazil .
METHODS	A total of 148 individuals with chronic LBP will participate in the study .
METHODS	Included individuals will be randomly allocated to participate in an 8-week treatment program based on the MSI-based classification or a general exercise program of stretching and strengthening exercises .
METHODS	Pain intensity , disability , and global impression of recovery will be assessed by a blinded assessor at baseline and at follow-up appointments after treatment ( 2 months ) and 4 and 6 months after randomization .
CONCLUSIONS	Therapists will not be blinded .
CONCLUSIONS	The results of this study may contribute to a better understanding of the efficacy of treatments based on classification of participants with chronic LBP into subgroups .

###26121805
BACKGROUND	Amino acid infusion is frequently selected to avoid hypothermia during surgery .
BACKGROUND	However , changes in electrolytic concentration resulting from its use are unclear .
BACKGROUND	The aim of this study was to identify the effect of amino acid on body temperature and changes in electrolytic concentrations .
METHODS	Thirty women undergoing breast cancer surgery under general anesthesia were divided into the following three groups : no amino acid administration , low-dose administration ( 2 ml x kg ( -1 ) x hr ( -1 ) ) , and high-dose administration ( 4 ml x kg ( -1 ) x hr ( -1 ) ) .
METHODS	Esophageal temperature was recorded every ten minutes and arterial blood samples were obtained before and after surgery .
METHODS	Body temperatures at each time point and arterial blood gas data , including blood gases , electrodes , serum glucose , and hematocrit were compared between the three groups .
RESULTS	Body temperature started to increase significantly 40 minutes after starting general anesthesia in the high-dose group , 90 minutes after starting general anesthesia in the low-dose group compared with the no amino acid group .
RESULTS	Body temperature was maintained until surgery was completed .
RESULTS	The concentration of sodium ion decreased significantly ( 2.4 mmol x l ( -1 ) ) in the high-dose group compared with the other two groups .
RESULTS	The concentration of other electrolytes , including potassium , chloride , and calcium , did not change significantly .
CONCLUSIONS	Perioperative amino acid administration was effective in maintaining a stable body temperature during surgery under general anesthesia .
CONCLUSIONS	However , sodium ion concentration might decrease after amino acid administration of 4 ml x kg ( -1 ) x hr ( -1 ) or greater .

###25194963
OBJECTIVE	The aim of this study was to investigate the effect of a 6-wk intervention with either lifestyle intervention ( increased physical activity and a low-calorie diet ) or a meal replacement regimen on glycemic control in patients who are prediabetic and have impaired fasting glucose .
METHODS	Forty-two overweight or obese men and women ( age 54 8 y ; weight 95.1 11.9 kg ; body mass index [ BMI ] 32.8 2.89 kg/m ( 2 ) ) were included in this randomized controlled clinical trial .
METHODS	Patients in the lifestyle group ( LS ; n = 14 ) received dietary counseling sessions ( fat-restricted low-calorie diet ) and instructions on how to increase physical activity .
METHODS	Patients in the meal replacement group ( MR ; n = 28 ) were instructed to replace two daily meals with a low-calorie , high soy-protein drink with a low glycemic index .
RESULTS	Both interventions resulted in a significant decrease in body weight and BMI , although the reduction was more pronounced ( P < 0.05 ) in the MR group .
RESULTS	In both groups , glucose concentrations decreased significantly ( LS : -12 mg/dL , P < 0.01 ; MR : -11 mg/dL , P < 0.01 ) , and mean glucose levels returned to the normal range .
RESULTS	Insulin ( LS : -1 U/mg [ not significant ] ; MR : -6.3 U/mg , P < 0.01 ) and homeostasis model assessment of insulin resistance ( HOMA-IR ; LS -0.92 , P < 0.01 ; MR : -2.1 , P < 0.01 ) were also significantly lower following both interventions ; again improvements were more pronounced in the MR group ( insulin : P < 0.05 ; HOMA P < 0.01 ) CONCLUSION : It can be concluded that meal replacement is an effective intervention for rapid improvement of elevated fasting glucose and increased insulin concentrations , these being important biomarkers of the prediabetic state .
RESULTS	The 6-wk intervention has shown that the effect of meal replacement on fasting blood glucose was comparable to the effect of lifestyle intervention .
RESULTS	The alterations in BMI , insulin , and HOMA-IR were significantly more pronounced following the meal replacement regimen .

###25530275
OBJECTIVE	Adverse reactions during propofol sedation include a decrease in arterial blood pressure , propofol-induced pain on injection , and airway complications .
OBJECTIVE	The purpose of this study was to investigate whether combined use of intravenous propofol and inhaled nitrous oxide could decrease the hypotensive and other adverse effects of propofol .
METHODS	We designed and implemented a prospective , randomized controlled trial .
METHODS	Patients undergoing dental procedures requiring intravenous sedation were randomly allocated to 2 groups : group P comprised those receiving sedation with propofol alone , and group N+P comprised those receiving sedation with 40 % nitrous oxide inhalation and propofol .
METHODS	During the dental procedures , the sedation level was maintained at an Observer 's Assessment of Alertness/Sedation scale score of 4 by adjusting propofol 's target plasma concentration .
METHODS	Nitrous oxide inhalation was the predictor variable , whereas the hemodynamic changes , amount and concentration of propofol , and adverse events were the outcome variables .
RESULTS	Eighty-eight patients were successfully analyzed without any complications .
RESULTS	The total amount of propofol was significantly less in group N+P ( 249.8 121.7 mg ) than in group P ( 310.3 122.4 mg ) ( P = .022 ) , and the mean concentration of propofol was significantly less in group N+P ( 1.81 0.34 g/mL ) than in group P ( 2.05 0.44 g/mL ) ( P = .006 ) .
RESULTS	The mean blood pressure reduction in group N+P ( 11.0 8.0 mm Hg ) was significantly smaller than that in group P ( 15.8 10.2 mm Hg ) ( P = .034 ) .
RESULTS	Pain associated with the propofol injection and memory of the procedure were less in group N+P ( P = .011 and P = .048 , respectively ) .
RESULTS	Nitrous oxide did not affect respiratory conditions or recovery characteristics .
CONCLUSIONS	The results of this study suggest that nitrous oxide inhalation combined with propofol sedation attenuates the hypotensive effect and pain associated with propofol injections , along with potentiating the amnesic effect .

###24485296
BACKGROUND	Recombinant granulocyte colony-stimulating factors ( G-CSFs ) reduce the incidence and duration of chemotherapy-induced neutropenia and febrile neutropenia when given as adjunct therapy to patients receiving myelosuppressive chemotherapy .
BACKGROUND	Balugrastim is a long-acting G-CSF composed of a genetic fusion between recombinant human serum albumin and G-CSF .
BACKGROUND	We compared the efficacy and safety of balugrastim and pegfilgrastim , a long-acting pegylated recombinant G-CSF , in patients with breast cancer who were scheduled to receive chemotherapy .
METHODS	In this double-blind randomized phase III trial , patients with 1.5 10 ( 9 ) neutrophils/L were randomly assigned to subcutaneous injections of balugrastim 40 mg ( n = 153 ) or pegfilgrastim 6 mg ( n = 151 ) .
METHODS	The primary efficacy end point was the duration of severe neutropenia ( DSN ) ( days with an absolute neutrophil count [ ANC ] < 0.5 10 ( 9 ) cells/L ) during cycle 1 .
METHODS	Efficacy analyses were performed in the per-protocol ( PP ) population .
METHODS	In a separate open-label single-arm study , newly recruited patients ( n = 77 ) received balugrastim 40 mg and were included in the safety analysis .
RESULTS	The mean DSN in cycle 1 was 1.1 days in the balugrastim group and 1.0 days in the pegfilgrastim group ( 95 % confidence interval [ CI ] , -0.13 -0.37 ) .
RESULTS	Two and 4 patients , respectively , had febrile neutropenia during cycle 1 .
RESULTS	Twenty percent of patients in the balugrastim group and 19 % in the pegfilgrastim group had adverse events ( AEs ) considered to be related to study medication ; 3.9 % and 4.7 % of patients , respectively , experienced serious AEs .
CONCLUSIONS	This study demonstrates the comparable safety and efficacy profile of balugrastim and pegfilgrastim and the noninferiority of balugrastim for reduction in DSN .
CONCLUSIONS	There were no unexpected safety events .

###26095389
BACKGROUND	Variations in institutional practice may contribute to different outcomes of cancer treatment .
BACKGROUND	The impact of interinstitutional heterogeneity on outcomes between hospitals after oesophagectomy has not been examined previously using data from surgical clinical trials .
METHODS	The data from two phase III trials for oesophageal cancer were used .
METHODS	Japan Clinical Oncology Group ( JCOG ) 9204 involved oesophagectomy ( 92-OP ) versus oesophagectomy plus postoperative chemotherapy ( 92-POST ) , with accrual from 1992 to 1997 .
METHODS	JCOG9907 involved postoperative chemotherapy ( 99-POST ) versus preoperative chemotherapy ( 99-PRE ) , with accrual from 2000 to 2006 .
METHODS	Hospitals contributing fewer than three patients were excluded .
METHODS	The influence of time and preoperative chemotherapy on interinstitutional heterogeneity related to postoperative complications and 5-year overall survival were evaluated by comparisons within and between these trial groups .
METHODS	Heterogeneity was estimated by a mixed-effects model after adjusting for age , sex , performance status , location of the primary tumour and clinical stage .
RESULTS	Twelve hospitals in 92-OP ( 114 patients ) , 13 in 92-POST ( 114 ) , 19 in 99-POST ( 158 ) and 18 in 99-PRE ( 154 ) were eligible .
RESULTS	There was considerable heterogeneity in predicted postoperative complications in both groups in JCOG9204 ( median 31.3 ( range 15.0-68 .2 ) per cent ) , and in 99-PRE ( 35.2 ( 22.6-46 .6 ) per cent ) but not in 99-POST ( 27.7 ( 27.7-27 .7 ) per cent ) from JCOG9907 .
RESULTS	A similar pattern was seen for predicted overall survival ( 92-POST : 66.4 ( range 64.1-68 .9 ) per cent ; 99-PRE : 55.9 ( 54.0-59 .7 ) per cent ; 99-POST : 44.4 ( 44.4-44 .4 ) per cent ) .
CONCLUSIONS	Interinstitutional heterogeneity regarding complications and survival after oesophagectomy is a problem that merits wider consideration .

###26022817
BACKGROUND	Hemodialysis patients are high absorbers of intestinal cholesterol ; they benefit less than other patient groups from statin therapy , which inhibits cholesterol synthesis .
OBJECTIVE	This study sought to investigate whether the individual cholesterol absorption rate affects atorvastatin 's effectiveness to reduce cardiovascular risk in hemodialysis patients .
METHODS	This post-hoc analysis included 1,030 participants in the German Diabetes and Dialysis Study ( 4D ) who were randomized to either 20 mg of atorvastatin ( n = 519 ) or placebo ( n = 511 ) .
METHODS	The primary endpoint was a composite of major cardiovascular events .
METHODS	Secondary endpoints included all-cause mortality and all cardiac events .
METHODS	Tertiles of the cholestanol-to-cholesterol ratio , which is an established biomarker of cholesterol absorption , were used to identify high and low cholesterol absorbers .
RESULTS	A total of 454 primary endpoints occurred .
RESULTS	On multivariate time-to-event analyses , the interaction term between tertiles and treatment with atorvastatin was significantly associated with the risk of reaching the primary endpoint .
RESULTS	Stratified analysis by cholestanol-to-cholesterol ratio tertiles confirmed this effect modification : atorvastatin reduced the risk of reaching the primary endpoint in the first tertile ( hazard ratio [ HR ] : 0.72 ; p = 0.049 ) , but not the second ( HR : 0.79 ; p = 0.225 ) or third tertiles ( HR : 1.21 ; p = 0.287 ) .
RESULTS	Atorvastatin consistently significantly reduced all-cause mortality and the risk of all cardiac events in only the first tertile .
CONCLUSIONS	Intestinal cholesterol absorption , as reflected by cholestanol-to-cholesterol ratios , predicts the effectiveness of atorvastatin to reduce cardiovascular risk in hemodialysis patients .
CONCLUSIONS	Those with low cholesterol absorption appear to benefit from treatment with atorvastatin , whereas those with high absorption do not benefit .

###24571870
BACKGROUND	Preoperative incisional local anaesthesia with ropivacaine is a common method of providing post-laparoscopy pain relief .
BACKGROUND	The pulmonary recruitment manoeuvre also provides pain relief , but the combined effect of these two methods on pain following laparoscopic procedures has not been reported .
BACKGROUND	We investigated the efficacy of combining local anaesthetic infiltration of ropivacaine with pulmonary recruitment manoeuvre on postoperative pain following diagnostic hysteroscopy and laparoscopy .
METHODS	This prospective , randomized , controlled study involved 60 patients divided into two groups ( n = 30 , each ) .
METHODS	Group 1 received 20 ml of 0.5 % ropivacaine injected peri-incisionally preoperatively , with intra-abdominal carbon dioxide removed by passive deflation .
METHODS	Group 2 received 20 ml of 0.5 % ropivacaine injected peri-incisionally with five manual inflations of the lungs with a positive-pressure ventilation of 40 cmH2O at the end of surgery .
METHODS	The last inflation was held for 5 seconds .
METHODS	The intensity of postoperative incisional and shoulder pain was evaluated using a numerical rating scale at 0 , 2 , 4 , 8 , 12 , 24 and 48 hours postoperatively by an independent blinded anaesthesiologist .
METHODS	Tramadol was given postoperatively for analgesia .
RESULTS	Compared with group 1 , incisional ropivacaine infiltration combined with pulmonary recruitment manoeuvre significantly reduced dynamic pain at 0 hour , 4 hours , and 24 hours postoperatively ( 4.1 2.2 vs. 2.1 1.9 , P = 0.002 ; 2.7 2.7 vs. 1.2 1.3 , P = 0.035 ; and 3.5 2.1 vs. 2.1 1.8 , P = 0.03 , respectively ) .
RESULTS	Static incisional pain was significantly relieved at 0 hour , 2 hours , and 24 hours postoperatively ( 3.1 1.7 vs. 1.6 1.3 , P = 0.001 ; 1.4 1.3 vs. 0.5 0.8 , P = 0.012 ; and 2.3 1.9 vs. 1.0 1.5 , P = 0.038 , respectively ) .
RESULTS	Group 2 had more patients without shoulder pain ( P < 0.05 ) and fewer requiring tramadol ( P < 0.05 ) .
CONCLUSIONS	Ropivacaine with pulmonary recruitment manoeuvre provided simple and effective pain relief after diagnostic hysteroscopy and laparoscopy .

###24456286
BACKGROUND	Anorexia nervosa ( AN ) , a prevalent psychiatric disorder predominantly affecting women , is characterized by self-induced starvation and low body weight .
BACKGROUND	Increased clinical fractures are common , and most women have low bone mineral density ( BMD ) .
BACKGROUND	Previously investigated treatments have led to no or modest increases in BMD in AN .
OBJECTIVE	Our objective was to investigate the effect of teriparatide ( TPT ; human PTH [ 1-34 ] ) , an anabolic agent , on low bone mass in women with AN .
METHODS	This randomized , placebo-controlled trial at a clinical research center included 21 women with AN : 10 ( mean age SEM , 47 2.7 years ) treated with TPT and 11 ( 47.1 2.3 years ) treated with placebo .
METHODS	TPT ( 20 g s.c. ) or placebo was administered for 6 months .
METHODS	Our primary outcome measure was change in BMD of the spine and hip by dual-energy x-ray absorptiometry .
METHODS	Secondary outcome measures included changes in serum N-terminal propeptide of type 1 procollagen ( P1NP ) , C-terminal collagen cross-links , sclerostin , and IGF-1 levels .
RESULTS	At 6 months , spine BMD increased significantly more with TPT ( posteroanterior spine , 6.0 % 1.4 % ; lateral spine , 10.5 % 2.5 % ) compared with placebo ( posteroanterior spine , 0.2 % 0.7 % , P < .01 ; lateral spine , -0.6 % 1.0 % ; P < .01 ) .
RESULTS	The results remained significant after controlling for baseline body mass index , P1NP , and IGF-1 .
RESULTS	Changes in femoral neck ( P = .4 ) and total hip ( P = 0.8 ) BMD were comparable in both groups , as were changes in weight .
RESULTS	Serum P1NP levels increased after 3 months of TPT treatment and remained at this higher level at 6 months , whereas P1NP levels were unchanged in the placebo group ( P = .02 ) .
RESULTS	TPT was well-tolerated by all subjects .
CONCLUSIONS	This study demonstrates that TPT administration increases spine BMD substantially after only 6 months of therapy in women with AN .

###25130503
BACKGROUND	Cluster immunotherapy represents an interesting alternative to conventional up-dosing schedules because it allows achieving the maintenance dose within a shorter time interval .
BACKGROUND	In this study , the efficacy and safety of cluster immunotherapy with a high polymerized allergen extract of a grass/rye pollen mixture have been evaluated in a randomized , double-blind , placebo-controlled , multicenter study .
METHODS	In total , 121 patients with allergic rhinoconjunctivitis due to grass pollen were randomized 1:1 to verum or placebo group .
METHODS	A short cluster up-dosing schedule of only 1week was applied to achieve the maintenance dose which was administered monthly during the study period of 1year .
METHODS	Total combined symptom and medication score ( TCS ) was defined as primary outcome parameter .
METHODS	Secondary outcome parameters were individual symptom and medication scores , ` well days , ' global improvement as well as immunological effects and nasal allergen challenge .
METHODS	The safety profile was evaluated based on the European academy of allergy and clinical immunology grading system .
RESULTS	Significant reduction in the verum compared to the placebo group ( intention-to-treat , population , verum : n = 55 ; placebo : n = 47 ) was found regarding TCS ( P = 0.005 ) , rhinoconjunctivitis total symptom score ( RTSS , P = 0.006 ) , and total rescue medication score ( TRMS , P = 0.002 ) .
RESULTS	Additionally , secondary outcomes such as ` well days , ' nasal challenge results , and increase of specific IgG4 were in favor of the active treatment .
RESULTS	All systemic adverse reactions ( 0.8 % of all injections in the verum group ) were of mild intensity .
RESULTS	No severe reactions related to the study medication were observed .
CONCLUSIONS	Cluster immunotherapy with high polymerized grass pollen extracts resulted in significant clinical efficacy and has been shown to be a safe treatment for grass pollen-allergic patients .

###24705678
BACKGROUND	Patients with idiopathic pulmonary fibrosis ( IPF ) have severely limited exercise capacity due to dyspnea , hypoxemia , and abnormal lung mechanics .
BACKGROUND	This pilot study was designed to determine whether pulmonary rehabilitation were efficacious in improving the 6-min walk test ( 6-MWT ) distance , exercise oxygen uptake , respiratory muscle strength [ maximum inspiratory pressure ( MIP ) ] , and dyspnea in patients with IPF .
BACKGROUND	Underlying physiological mechanisms and effects of the intervention were investigated .
METHODS	Subjects were randomly assigned to a 3-month pulmonary rehabilitation program ( n = 11 ) or to a control group ( n = 10 ) .
METHODS	All subjects initially underwent the 6-MWT and constant load exercise gas exchange studies .
RESULTS	Subjects in the rehabilitation group increased treadmill exercise [ metabolic equivalent of task-minutes ] over the first 14 sessions .
RESULTS	Beneficial effects on physical function resulted in those who completed rehabilitation .
RESULTS	Subjects who completed the program increased cycle ergometer time and maintained exercise oxygen consumption ( exercise VO ( 2 ) ) at the baseline level over 3 months , while the control group suffered a significant decrease in exercise VO ( 2 ) .
RESULTS	Rehabilitation subjects also increased their MIP .
RESULTS	Plasma lactate doubled and brain natriuretic peptide levels increased significantly after exercise , as did the plasma amino acids glutamic acid , arginine , histidine , and methionine .
RESULTS	These changes were associated with significant decreases in arterial oxygen saturation and increases in 15-F ( 2t ) - isoprostanes after exercise .
CONCLUSIONS	Pulmonary rehabilitation effectively maintained exercise oxygen uptake over 3 months and lengthened constant load exercise time in patients with moderately severe IPF .
CONCLUSIONS	Exercise endurance on cycle ergometry testing was limited by dyspnea and severe hypoxemia associated with systemic oxidant stress .

###25511816
BACKGROUND	Silent infarction in the brain can be detected in around 34 per cent of patients after carotid endarterectomy ( CEA ) and 54 per cent after carotid angioplasty and stenting ( CAS ) .
BACKGROUND	This study compared the risk of new infarctions in the brain in patients undergoing CEA or CAS .
METHODS	Consecutive patients with internal carotid artery ( ICA ) stenosis exceeding 70 per cent were screened for inclusion in this prospective study .
METHODS	Patients with indications for intervention , and eligible for both methods , were allocated randomly to CEA or CAS .
METHODS	Neurological examination , cognitive function tests and MRI of the brain were undertaken before and 24h after intervention .
RESULTS	Of 150 randomized patients , 73 ( 47 men ; mean age 649 ( 71 ) years ) underwent CEA and 77 ( 58 men ; 664 ( 75 ) years ) had CAS .
RESULTS	New infarctions on MRI were found more frequently after CAS ( 49 versus 25 per cent ; P = 0002 ) .
RESULTS	Lesion volume was also significantly greater after CAS ( P = 0010 ) .
RESULTS	Multiple logistic regression analyses identified intervention in the right ICA as the only independent predictor of brain infarction ( odds ratio 210 , 95 per cent c.i. 103 to 425 ; P = 0040 ) .
RESULTS	Stroke or transient ischaemic attack occurred in one patient after CEA and in two after CAS .
RESULTS	No significant differences were found in cognitive test results between the groups .
CONCLUSIONS	These data confirm a higher risk of silent infarction in the brain on MRI after CAS in comparison with CEA , but without measurable change in cognitive function .
BACKGROUND	NCT01591005 ( http://www.clinicaltrials.gov ) .

###25500985
OBJECTIVE	To compare ocular surface changes after strabismus surgery with different incisions .
METHODS	One hundred and twenty eyes with exotropia were randomly assigned to Group A ( limbal incision ) or Group B ( fornix incision ) .
METHODS	Dry eye questionnaire , corneal sensitivity , tear film breakup time ( TFBUT ) , Schirmer I test ( SIT ) , and corneal fluorescein staining ( CFS ) were assessed at 1 day preoperatively and at different postoperative times .
RESULTS	In the A group , dry eye questionnaire scores increased and TFBUT decreased at postoperative weeks 1 , 2 , and 4 .
RESULTS	Corneal sensitivity decreased at postoperative weeks 1 and 2 .
RESULTS	In the B group , dry eye questionnaire scores increased and TFBUT decreased at postoperative weeks 1 and 2 .
RESULTS	Corneal sensitivity did not change .
RESULTS	Postoperative between-group differences were significant in dry eye questionnaire scores ( P = 0.0009 , 1 week ; P < 0.0001 , 2 weeks ; P = 0.0001 , 4 weeks ) and TFBUT ( P = 0.004 , 1 week ; P = 0.0003 , 2 weeks ; P = 0.0001 , 4 weeks ) .
RESULTS	Between-group differences in CFS were significant postoperatively ( P = 0.045 , 1 week ; P = 0.020 , 2 weeks ) .
CONCLUSIONS	Compared to fornix incision , limbal incision results in more serious dry eye symptoms and has a greater impact on corneal sensitivity and tear film stability .

###25266159
BACKGROUND	Ivacaftor is used to treat patients with CF and a G551D gating mutation ; the KONNECTION study assessed the efficacy and safety of ivacaftor in patients with CF and a non-G551D gating mutation .
METHODS	Patients with CF 6-years - old with non-G551D gating mutations received ivacaftor 150mg q12h or placebo for 8weeks in this 2-part , double-blind crossover study ( Part 1 ) with a 16-week open-label extension ( Part 2 ) .
METHODS	The primary efficacy outcome was absolute change in FEV1 through 8 and 24weeks of ivacaftor treatment ; secondary outcomes were changes in BMI , sweat chloride , and CFQ-R and safety through 8 and 24weeks of treatment .
RESULTS	Eight weeks of ivacaftor resulted in significant improvements in percent predicted FEV1 , BMI , sweat chloride , and CFQ-R scores that were maintained through 24weeks .
RESULTS	Ivacaftor was generally well tolerated .
CONCLUSIONS	Ivacaftor was efficacious in a group of patients with CF who had selected non-G551D gating mutations .

###24321402
BACKGROUND	Evidence has suggested that periodontal disease is associated with an increased risk of various adverse pregnancy and birth outcomes .
BACKGROUND	However , several large clinical randomized controlled trials failed to demonstrate periodontal therapy during pregnancy reduced the incidence of adverse pregnancy and birth outcomes .
BACKGROUND	It has been suggested that the pre-conception period may be an optimal period for periodontal disease treatment rather than during pregnancy .
BACKGROUND	To date , no randomized controlled trial ( RCT ) has examined if treating periodontal disease before pregnancy reduces adverse birth outcomes .
BACKGROUND	This study aims to examine if the pre-conception treatment of periodontal disease will lead to improved periodontal status during late pregnancy and subsequent birth outcomes .
METHODS	A sample of 470 ( 235 in each arm of the study ) pre-conception women who plan to conceive within one year and with periodontal disease will be recruited for the study .
METHODS	All participants will be randomly allocated to the intervention or control group .
METHODS	The intervention group will receive free therapy including dental scaling and root planning ( the standard therapy ) , supragingival prophylaxis , and oral hygiene education .
METHODS	The control group will only receive supragingival prophylaxis and oral hygiene education .
METHODS	Women will be followed throughout their pregnancy and then to childbirth .
METHODS	The main outcomes include periodontal disease status in late pregnancy and birth outcomes measured such as mean birth weight ( grams ) , and mean gestational age ( weeks ) .
METHODS	Periodontal disease will be diagnosed through a dental examination by measuring probing depth , clinical attachment loss and percentage of bleeding on probing ( BOP ) between gestational age of 32 and 36weeks .
METHODS	Local and systemic inflammatory mediators are also included as main outcomes .
CONCLUSIONS	This will be the first RCT to test whether treating periodontal disease among pre-conception women reduces periodontal disease during pregnancy and prevents adverse birth outcomes .
CONCLUSIONS	If the effect of pre-pregnancy periodontal treatment is confirmed , this intervention could be recommended for application in low - or middle-income countries to improve both oral health and maternal and child health .
BACKGROUND	This trial is registered with Chinese Clinical Trial Registry ( ChiCTR ) : ChiCTR-TRC-12001913 .

###24310853
OBJECTIVE	Our aim was compare onset time of sciatic nerve blockade ( SNB ) performed distal to the subgluteal fold using four different ultrasound ( US ) - guided approaches in patients undergoing foot or ankle surgery .
METHODS	Patients were assigned to one of four groups : SI patients received SNB using short-axis ( SA ) view of the SN and in-plane ( IP ) placement of block needle ( SA-IP approach ) ; LI patients received SNB using long-axis ( LA ) view of the SN and IP needle placement ( LA-IP approach ) ; SO patients received the block using SA view of the SN and out-of-plane ( OP ) needle placement ( SA-OP approach ) ; LO patients received SNB using LA view of the SN and OP needle placement ( LA-OP ) .
METHODS	Primary outcome included onset time of sensory and motor SNB .
METHODS	Patient satisfaction concerning the postoperative analgesia was noted .
RESULTS	The LI group had significantly faster onset of sensory blockade on the distribution of tibial nerve ( 16.0 5.6 vs. 23.5 3.6 ) and common peroneal nerve ( 12.5 4.3 vs. 19.1 5.4 min ) in comparison with the LO group .
RESULTS	The LI group had significantly faster onset of motor blockade on the distribution of tibial nerve ( 21.1 6.2 vs. 26 3.1 ) and common peroneal nerve ( 17.7 4.8 vs. 23.7 5.8 min . )
RESULTS	in comparison with the LO group .
RESULTS	The LI group had the highest rate of patient satisfaction for postoperative analgesia and the LO group had the lowest .
CONCLUSIONS	The LA-IP approach resulted in a rapid onset of SNB and was associated with the best satisfaction for postoperative analgesia in comparison with LA-OP , SA-IP , and SA-OP approaches for patients undergoing foot and ankle surgery .

###25199409
BACKGROUND	Tick and tsetse-borne diseases ( TTBDs ) constrain livestock production in tropical and subtropical regions of the world .
BACKGROUND	Of this community of endemic diseases , East coast fever ( T. parva ) is the most important tick-borne disease ( TBD ) accounting for 70 % of all losses due to TBDS in this region where control efforts target either tsetse or TBDs and seldom both .
BACKGROUND	In those instances where simultaneous pyrethroid insecticide TTBD control is implemented , collateral benefits of tsetse control on TBD control have not been quantified .
BACKGROUND	In the interest of guiding future TTBD control efforts , the effect of restricting pyrethroid insecticides to the legs , belly and ears ( RAP ) of cattle for tsetse and trypanosomiasis control on T. parva prevalence in crop-livestock production systems in Tororo district , south-eastern Uganda was determined .
METHODS	We randomly allocated 16 villages to diminazene diaceturate ( DA ) and 3 graded RAP ( 25 % , 50 % and 75 % of village herd sprayed respectively ) treatment regimens .
METHODS	All cattle were ear-tagged , treated with diminazene diaceturate ( DA ) and those in regimens 2-4 received monthly graded RAP .
METHODS	Blood samples taken fourteen days post DA treatment and once three monthly were analysed by molecular techniques for T. parva .
RESULTS	In total , 8,975 samples from 3,084 animals were analysed .
RESULTS	Prevalence of T. parva varied between 1-3 % in different treatment regimens .
RESULTS	RAP regimens were associated with slightly lower average risk of infection compared to DA .
RESULTS	However , the confidence interval was broad and the result was not statistically significant .
RESULTS	There was no evidence of a dose response relationship between graded RAP and T. parva prevalence .
RESULTS	These findings are discussed herein with regard to endemic stability development to different TBDs .
CONCLUSIONS	We found only a slight effect of RAP on T. parva infection .
CONCLUSIONS	Since sample size determination was based on trypanosomes incidence , the study was underpowered given the low T. parva prevalence .
CONCLUSIONS	While the findings need to be confirmed in future studies , the observed slight reduction in the risk of infection with T. parva might not compromise endemic stability .

###24691156
OBJECTIVE	To report the primary outcomes of a cluster randomized clinical trial of Behavioral Activities Intervention ( BE-ACTIV ) , a behavioral intervention for depression in nursing homes .
METHODS	Twenty-three nursing homes randomized to BE-ACTIV or treatment as usual ( TAU ) ; 82 depressed long-term care residents recruited from these nursing homes .
METHODS	BE-ACTIV participants received 10 weeks of individual therapy after a 2-week baseline .
METHODS	TAU participants received weekly research visits .
METHODS	Follow-up assessments occurred at 3 - and 6-month posttreatment .
RESULTS	BE-ACTIV group participants showed better diagnostic recovery at posttreatment in intent-to-treat analyses adjusted for clustering .
RESULTS	They were more likely to be remitted than TAU participants at posttreatment and at 3-month posttreatment but not at 6 months .
RESULTS	Self-reported depressive symptoms and functioning improved in both groups , but there were no significant treatment by time interactions in these variables .
CONCLUSIONS	BE-ACTIV was superior to TAU in moving residents to full remission from depression .
CONCLUSIONS	The treatment was well received by nursing home staff and accepted by residents .
CONCLUSIONS	A large proportion of participants remained symptomatic at posttreatment , despite taking one or more antidepressants .
CONCLUSIONS	The results illustrate the potential power of an attentional intervention to improve self-reported mood and functioning , but also the difficulties related to both studying and implementing effective treatments in nursing homes .

###25711330
OBJECTIVE	The aim of the study was to describe the prevalence and correlates of chronic obstructive pulmonary disease ( COPD ) in a multicentre international cohort of persons living with HIV ( PLWH ) .
METHODS	We performed a cross-sectional analysis of adult PLWH , nave to HIV treatment , with baseline CD4 cell count > 500 cells/L enrolled in the Pulmonary Substudy of the Strategic Timing of AntiRetroviral Treatment ( START ) trial .
METHODS	We collected standardized , quality-controlled spirometry .
METHODS	COPD was defined as forced expiratory volume in 1s : forced vital capacity ( FEV1 : FVC ) ratio less than the lower limit of normal .
RESULTS	Among 1026 participants from 80 sites and 20 countries , the median age was 36 [ interquartile range ( IQR ) 30 , 44 ] years , 29 % were female , and the median time since HIV diagnosis was 1.2 ( IQR 0.4 , 3.5 ) years .
RESULTS	Baseline median CD4 cell count was 648 ( IQR 583 , 767 ) cells/L , median viral load was 4.2 ( IQR 3.5 , 4.7 ) log10 HIV-1 RNA copies/mL , and 10 % had a viral load 400 copies/mL despite lack of HIV treatment .
RESULTS	Current/former/never smokers comprised 28 % / 11 % / 61 % of the cohort , respectively .
RESULTS	COPD was present in 6.8 % of participants , and varied by age , smoking status and region .
RESULTS	Forty-eight per cent of those with COPD reported lifelong nonsmoking .
RESULTS	In multivariable regression , age and pack-years of smoking had the strongest associations with FEV1 : FVC ratio ( P < 0.0001 ) .
RESULTS	There was a significant effect of region on FEV1 : FVC ratio ( P = 0.010 ) .
CONCLUSIONS	Our data suggest that , among PLWH who were nave to HIV treatment and had CD4 cell counts > 500 cells/L , smoking and age were important factors related to COPD .
CONCLUSIONS	Smoking cessation should remain a high global priority for clinical care and research in PLWH .

###26027222
BACKGROUND	Remote ischemic preconditioning has gained clinicians ' attention as a technique to protect the heart in patients undergoing cardiac surgery under cardiopulmonary bypass .
BACKGROUND	While experimental data report neuroprotective properties of remote ischemic preconditioning , we failed to find any clinical studies investigating its effects on neurologic outcome in cardiac surgery .
OBJECTIVE	This prospective randomized placebo-controlled study was undertaken with the aim of elucidating the role of remote ischemic preconditioning for neuroprotection in cardiac surgery .
METHODS	88 patients with coronary heart disease scheduled for on-pump coronary bypass grafting surgery were randomized to receive either remote ischemic preconditioning or control .
METHODS	We studied S100B peptide and neuron-specific enolase to assess neurological damage .
METHODS	Psychophysiological tests were employed to investigate cognitive function after surgery .
RESULTS	The perioperative dynamics of S100B and neuron-specific enolase followed similar patterns in both groups throughout the observation period .
RESULTS	At the end of surgery , level of S100B was significantly higher in the preconditioning group as compared to controls -- 0.58 ( 0.33-0 .65 ) vs. 0.34 ( 0.23-0 .42 ) mcg/l , p < O. 01 ) .
RESULTS	No other significant between-group differences in biochemical markers were observed .
RESULTS	No between-group differences in cognitive function and neurologic outcome after surgery were detected .
CONCLUSIONS	Our data suggest that remote ischemic preconditioning does not affect neuronal damage and neurologic outcome in patients operated under cardiopulmonary bypass .

###25008457
BACKGROUND	One of the pressing concerns in health care today is the slow rate at which promising interventions , supported by research evidence , move into clinical practice .
BACKGROUND	One potential way to speed this process is to conduct hybrid studies that simultaneously combine the collection of effectiveness and implementation relevant data .
BACKGROUND	This paper presents implementation relevant data collected during a randomized effectiveness trial of an abstinence incentive intervention conducted in substance use disorders treatment clinics at two Veterans Health Administration ( VHA ) medical centers .
METHODS	Participants included patients entering substance use disorders treatment with diagnoses of alcohol dependence and/or stimulant dependence that enrolled in the randomized trial , were assigned to the intervention arm , and completed a post intervention survey ( n = 147 ) .
METHODS	All staff and leadership from the participating clinics were eligible to participate .
METHODS	A descriptive process evaluation was used , focused on participant perceptions and contextual/feasibility issues .
METHODS	Data collection was guided by the RE-AIM and PARIHS implementation frameworks .
METHODS	Data collection methods included chart review , intervention cost tracking , patient and staff surveys , and qualitative interviews with staff and administrators .
RESULTS	Results indicated that patients , staff and administrators held generally positive attitudes toward the incentive intervention .
RESULTS	However , staff and administrators identified substantial barriers to routine implementation .
RESULTS	Despite the documented low cost and modest staff time required for implementation of the intervention , securing funding for the incentives and freeing up any staff time for intervention administration were identified as primary barriers .
CONCLUSIONS	Recommendations to facilitate implementation are presented .
CONCLUSIONS	Recommendations include : 1 ) solicit explicit support from the highest levels of the organization through , for example , performance measures or clinical practice guideline recommendations ; 2 ) adopt the intervention incrementally starting within a specific treatment track or clinic to reduce staff and funding burden until local evidence of effectiveness and feasibility is available to support spread ; and 3 ) educate staff about the process , goals , and value/effectiveness of the intervention and engage them in implementation planning from the start to enhance investment in the intervention .

###24745696
BACKGROUND	Bevacizumab , a monoclonal antibody that targets VEGF , has shown restricted activity in patients with advanced melanoma .
BACKGROUND	We aimed to assess the role of bevacizumab as adjuvant treatment for patients with resected melanoma at high risk of recurrence .
BACKGROUND	We report results from the preplanned interim analysis .
METHODS	We did a multicentre , open-label , randomised controlled phase 3 trial at 48 centres in the UK between July 18 , 2007 , and March 29 , 2012 .
METHODS	Patients aged 16 years or older with American Joint Committee on Cancer stage ( AJCC ) stage IIB , IIC , and III cutaneous melanoma were randomly allocated ( 1:1 ) , via a central , computer-based minimisation procedure , to receive intravenous bevacizumab 7.5 mg/kg , every 3 weeks for 1 year , or to observation .
METHODS	Randomisation was stratified by Breslow thickness of the primary tumour , N stage according to AJCC staging criteria , ulceration of the primary tumour , and patient sex .
METHODS	The primary endpoint was overall survival ; secondary endpoints included disease-free interval , distant-metastases interval and quality of life .
METHODS	Analysis was by intention-to-treat .
METHODS	This trial is registered as an International Standardised Randomised Controlled Trial , number ISRCTN81261306 .
RESULTS	1343 patients were randomised to either the bevacizumab group ( n = 671 ) or the observation group ( n = 672 ) .
RESULTS	Median follow-up was 25 months ( IQR 16-37 ) in the bevacizumab group and 25 months ( 17-37 ) in the observation group .
RESULTS	At the time of interim analysis , 286 ( 21 % ) of 1343 enrolled patients had died : 140 ( 21 % ) of 671 patients in the bevacizumab group , and 146 ( 22 % ) of 672 patients in the observation group .
RESULTS	134 ( 96 % ) of patients in the bevacizumab group died because of melanoma versus 139 ( 95 % ) in the observation group .
RESULTS	We noted no significant difference in overall survival between treatment groups ( hazard ratio [ HR ] 0.97 , 95 % CI 0.78-1 .22 ; p = 0.76 ) ; this finding persisted after adjustment for stratification variables ( HR 1.03 ; 95 % CI 0.81-1 .29 ; p = 0.83 ) .
RESULTS	Median duration of treatment with bevacizumab was 51 weeks ( IQR 21-52 ) and dose intensity was 86 % ( 41-96 ) , showing good tolerability .
RESULTS	180 grade 3 or 4 adverse events were recorded in 101 ( 15 % ) of 671 patients in the bevacizumab group , and 36 ( 5 % ) of 672 patients in the observation group .
RESULTS	Bevacizumab resulted in a higher incidence of grade 3 hypertension than did observation ( 41 [ 6 % ] vs one [ < 1 % ] ) .
RESULTS	There was an improvement in disease-free interval for patients in the bevacizumab group compared with those in the observation group ( HR 0.83 , 95 % CI 0.70-0 .98 , p = 0.03 ) , but no significant difference between groups for distant-metastasis-free interval ( HR 0.88 , 95 % CI 0.73-1 .06 , p = 0.18 ) .
RESULTS	No significant differences were noted between treatment groups in the standardised area under the curve for any of the quality-of-life scales over 36 months .
RESULTS	Three adverse drug reactions were regarded as both serious and unexpected : one patient had optic neuritis after the first bevacizumab infusion , a second patient had persistent erectile dysfunction , and a third patient died of a haemopericardium after receiving two bevacizumab infusions and was later identified to have had significant predisposing cardiovascular risk factors .
CONCLUSIONS	Bevacizumab has promising tolerability .
CONCLUSIONS	Longer follow-up is needed to identify an effect on the primary endpoint of overall survival at 5 years .

###24287940
BACKGROUND	No long-term studies have compared centrally acting drugs for treating obesity .
OBJECTIVE	To compare the efficacy and safety of diethylpropion ( DEP ) , fenproporex ( FEN ) , mazindol ( MZD ) , fluoxetine ( FXT ) and sibutramine ( SIB ) in promoting weight loss .
METHODS	A prospective , randomized , placebo ( PCB ) - controlled study conducted at a single academic institution .
METHODS	A total of 174 obese premenopausal women .
METHODS	Participants randomly received DEP 75mg ( n = 28 ) , FEN 25mg ( n = 29 ) , MZD 2mg ( n = 29 ) , SIB 15mg ( n = 30 ) , FXT 20mg ( n = 29 ) or PCB ( n = 29 ) daily over 52 weeks .
METHODS	Diet and physical activity were encouraged .
METHODS	The primary endpoints were changes in body weight and the proportion of women who achieved at least 5 % weight loss by week 52 in the intent-to-treat population .
METHODS	Other measurements included anthropometry , safety , metabolic and cardiovascular parameters .
RESULTS	Weight loss was greater than PCB ( -3.14.3 kg ) with DEP ( -10.06.4 kg ; P < 0.001 ) , SIB ( -9.55.9 kg ; P < 0.001 ) , FEN ( -7.86.9 kg ; P < 0.01 ) and MZD ( -7.44.9 kg ; P < 0.01 ) but not with FXT ( -2.54.1 kg ) .
RESULTS	Ten ( 33.3 % ) women lost5 % of their initial weight with PCB , compared with 20 ( 71.4 % ; P < 0.001 ) with DEP , 20 ( 69 % ; P < 0.02 ) with FEN , 21 ( 72.4 % ; P < 0.01 ) with MZD , 22 ( 73.3 % ; P < 0.001 ) with SIB and 10 ( 35.5 % ) with FXT .
RESULTS	Each medically treated group experienced more adverse events compared with PCB ( P < 0.001 ) .
RESULTS	Compared with PCB , constipation was more prevalent with DEP , SIB and MZD ( P < 0.01 ) ; anxiety was more prevalent with DEP ( P = 0.01 ) ; and irritability occurred more frequently with DEP and FEN ( P = 0.02 ) .
RESULTS	Significant improvements in the depression and anxiety scores , binge-eating episodes and quality of life correlated with weight loss .
CONCLUSIONS	The centrally acting drugs DEP , FEN , MZD and SIB were more effective than PCB in promoting weight loss in obese premenopausal women , with a satisfactory benefit-risk profile .

###24262299
BACKGROUND	Apathy is the most common neuropsychiatric symptom in Alzheimer 's disease ( AD ) and it is associated with changes in prefrontal neural circuits involved with generation of voluntary actions .
BACKGROUND	To date no effective treatment for apathy has been demonstrated .
OBJECTIVE	We aimed to investigate the effects and safety of repetitive transcranial direct current stimulation ( tDCS ) on apathy in moderate AD patients .
METHODS	Forty patients were randomized to receive either active or sham-tDCS over the left dorsolateral prefrontal cortex ( DLPFC ) .
METHODS	Patients received six sessions of intervention during 2 weeks and were evaluated at baseline , at week 1 and 2 , and after 1 week without intervention .
METHODS	Clinical raters , patients , and caregivers were blinded .
METHODS	The primary outcome was apathy .
METHODS	Global cognition and neuropsychiatric symptoms were examined as secondary outcomes .
RESULTS	The mean MMSE score at baseline was 15.2 2.9 and the mean Apathy Scale score was 27.7 6.7 .
RESULTS	Changes on apathy scores over time were not different between active and sham tDCS ( P = 0.552 for repeated measures ) .
RESULTS	Further analyses confirm that changes from baseline did not differ between groups after the sixth session ( active tDCS -1.95 ( 95 % CI -3.49 , -0.41 ) ; sham-tDCS -2.05 ( 95 % CI -3.68 , -0.42 ) ; P = 0.989 ] .
RESULTS	Similarly , tDCS had no effect on secondary outcomes ( P > 0.40 ) .
RESULTS	tDCS was well tolerated and not associated with significant adverse effects .
CONCLUSIONS	In this adequately powered study for minimal clinically significant difference , our findings show that using the parameters we chose for this study , repeated anodal tDCS over the left DLPFC had no effect on apathy in elderly patients with moderate AD .

###25602901
OBJECTIVE	We sought to identify the program fidelity factors associated with successful implementation of the Buckle-Up Safely program , targeting correct use of age-appropriate child car restraints .
METHODS	In 2010 , we conducted a cluster randomized controlled trial of 830 families with children attending preschools and long day care centers in South West Sydney , New South Wales , Australia .
METHODS	Families received the Buckle-Up Safely program in the intervention arm of the study ( 13 services ) .
METHODS	Independent observers assessed the type of restraint and whether it was used correctly .
RESULTS	This detailed process evaluation showed that the multifaceted program was implemented with high fidelity .
RESULTS	Program protocols were adhered to and messaging was consistently delivered .
RESULTS	Results from multilevel and logistic regression analyses show that age-appropriate restraint use was associated with attendance at a parent information session hosted at the center ( adjusted odd ratio [ AOR ] = 3.66 ; 95 % confidence interval [ CI ] = 1.61 , 8.29 ) and adversely affected by the child being aged 2 to 3 years ( AOR = 0.14 ; 95 % CI = 0.07 , 0.30 ) or being from a family with more than 2 children ( AOR = 0.34 ; 95 % CI = 0.17 , 0.67 ) .
CONCLUSIONS	Findings highlight the importance of parents receiving hands-on education regarding the proper use of age-appropriate child restraints .

###24598085
BACKGROUND	frail older people often require tailored rehabilitation in order to remain at home , especially following a period of hospitalisation .
BACKGROUND	Restorative care services aim to enhance an older person 's ability to remain improve physical functioning , either at home or in residential care but evidence of their effectiveness is limited .
OBJECTIVE	to evaluate the effectiveness of a restorative care service on institutional-free survival and health outcomes in frail older people referred for needs assessment in New Zealand .
METHODS	a randomised controlled trial of restorative care or usual care in 105 older people at risk of permanent residential who were follow-up over 24 months .
METHODS	The restorative care service was delivered in short-stay residential care facilities and at participants ' residences with the aim of reducing the requirement for permanent residential care .
METHODS	It included a comprehensive geriatric assessment and care plan developed and delivered , initially by a multi-disciplinary team and subsequently by home care assistants .
RESULTS	compared with usual care , there was a non-significant absolute risk reduction of 14.3 % for death or permanent residential care ( 8.8 % for residential care and 7.2 % for death alone ) for the restorative care approach .
RESULTS	There was no difference in levels of burden among caregivers .
CONCLUSIONS	restorative care models that utilise case management and multi-disciplinary care may positively impact on institutional-free survival for frail older people without adversely impacting on the health of caregivers .

###25571980
BACKGROUND	Isotopic glomerular filtration rate ( iGFR ) measurement is comparable to the inulin method .
BACKGROUND	In this study , we compared urinary and plasma iGFR methodologies in patients with diabetic nephropathy .
METHODS	A total of 147 patients from 3 sites in the Diabetic Intervention with Vitamins to Improve Nephropathy ( DIVINe ) trial provided 213 sets of urine and blood collections , at baseline , 18 and 36 months .
RESULTS	The mean ( with standard deviation ) plasma iGFR of 60.7 ( 24.9 ) ml/min/1 .73 m ( 2 ) compared to urinary iGFR of 52.0 ( 28.0 ) ml/min/1 .73 m ( 2 ) was statistically significant ( p value < 0.001 ) .
RESULTS	Although plasma and urinary iGFRs were highly related ( R ( 2 ) = 0.86 ) , plasma iGFR increasingly overestimated urinary iGFRs at lower GFRs .
RESULTS	In contrast to the cross-sectional analyses , the two measures of iGFR were weakly related ( R ( 2 ) = 0.32 ) in regard to patients ' change over 18 months of follow-up .
CONCLUSIONS	Plasma iGFR may not be a suitable method for accurately measuring GFR in patients with advancing degrees of chronic kidney disease from diabetic nephropathy .

###25240788
BACKGROUND	Latinos experience significant health disparities at the end of life compared with non-Latinos .
OBJECTIVE	To determine the feasibility of a patient navigator intervention to improve palliative care outcomes for Latino adults with serious illness .
METHODS	This was a pilot randomized controlled trial that included 64 Latino adults with life-limiting illness randomized to an intervention or a control group .
METHODS	All participants received a packet of linguistically matched materials on palliative care .
METHODS	In addition , intervention participants received up to five home visits from the bilingual , bicultural patient navigator .
METHODS	Visits focused on addressing barriers to palliative care through education , activation , and culturally tailored messaging .
METHODS	Outcomes included feasibility and advance care planning rates , documentation of pain management discussions in the medical record , and hospice utilization .
RESULTS	Of the 32 patients randomized to the intervention arm , 81 % had at least one home visit ( range 1-5 ) with the patient navigator .
RESULTS	Overall , advance care planning was higher in the intervention group ( 47 % [ n = 15 ] vs. 25 % [ n = 8 ] , P = 0.06 ) , and 79 % of intervention participants had a discussion about pain management documented in their medical record vs. 54 % of control patients ( P = 0.05 ) .
RESULTS	Hospice enrollment between the two groups ( n = 18 decedents ) was similar ( n = 7 intervention vs. n = 6 control ) ; length of stay in the intervention group was 36.451.6 vs. 19.733.6 days for control patients ( P = 0.39 ) .
CONCLUSIONS	A culturally tailored patient navigator intervention was feasible and suggests improved palliative care outcomes for Latinos facing advanced medical illness , justifying a fully powered randomized controlled trial .

###25450450
OBJECTIVE	To compare the impact of unconditional and conditional financial incentives on response rates among Australian general practitioners invited by mail to participate in an online survey about cancer care and to investigate possible differential response bias between incentive groups .
METHODS	Australian general practitioners were randomly allocated to unconditional incentive ( book voucher mailed with letter of invitation ) , conditional incentive ( book voucher mailed on completion of the online survey ) , or control ( no incentive ) .
METHODS	Nonresponders were asked to complete a small subset of questions from the online survey .
RESULTS	Among 3,334 eligible general practitioners , significantly higher response rates were achieved in the unconditional group ( 167 of 1,101 , 15 % ) compared with the conditional group ( 118 of 1,111 , 11 % ) ( P = 0.0014 ) , and both were significantly higher than the control group ( 74 of 1,122 , 7 % ; both P < 0.001 ) .
RESULTS	Although more positive opinions about cancer care were expressed by online responders compared with nonresponders , there was no evidence that the magnitude of difference varied by the incentive group .
RESULTS	The incremental cost for each additional 1 % increase above the control group response rate was substantially higher for the unconditional incentive group compared with the conditional incentive group .
CONCLUSIONS	Both unconditional and conditional financial incentives significantly increased response with no evidence of differential response bias .
CONCLUSIONS	Although unconditional incentives had the largest effect , the conditional approach was more cost-effective .

###24398818
BACKGROUND	Lipophilic opioids and local anesthetics are often given intrathecally in combination for labor analgesia .
BACKGROUND	However , the nature of the pharmacologic interaction between these drugs has not been clearly elucidated in humans .
METHODS	Three hundred nulliparous women randomly received 1 of 30 different combinations of fentanyl and bupivacaine intrathecally using a combined spinal-epidural technique for analgesia in the first stage of labor .
METHODS	Visual analogue scale pain scores were recorded for 30 min .
METHODS	Response was defined by percentage decrease in pain score from baseline at 15 and 30 min .
METHODS	Dose-response curves for individual drugs were fitted to a hyperbolic dose-response model using nonlinear regression .
METHODS	The nature of the drug interaction was determined using dose equivalence methodology to compare observed effects of drug combinations with effects predicted by additivity .
RESULTS	The derived dose-response models for individual drugs ( doses in micrograms ) at 15 min were : Effect = 100 dose / ( 13.82 + dose ) for fentanyl , and Effect = 100 dose / ( 1,590 + dose ) for bupivacaine .
RESULTS	Combinations of fentanyl and bupivacaine produced greater effects than those predicted by additivity at 15 min ( P < 0.001 ) and 30 min ( P = 0.015 ) ( mean differences , 9.1 [ 95 % CI , 4.1-14 .1 ] and 6.4 [ 95 % CI , 1.2-11 .5 ] units of the normalized response , respectively ) , indicating a synergistic interaction .
CONCLUSIONS	The pharmacologic interaction between intrathecal fentanyl and bupivacaine is synergistic .
CONCLUSIONS	Characterization and quantification of this interaction provide a theoretical basis and support for the clinical practice of combining intrathecal opioids and local anesthetics .

###26012639
OBJECTIVE	The objective of this study was to determine the cost-effectiveness of intra-arterial treatment within the 0 - to 6-hour window after intravenous tissue-type plasminogen activator within 0 - to 4.5-hour compared with intravenous tissue-type plasminogen activator alone , in the US setting and from a social perspective .
METHODS	A decision analytic model estimated the lifetime costs and outcomes associated with the additional benefit of intra-arterial therapy compared with standard treatment with intravenous tissue-type plasminogen activator alone .
METHODS	Model inputs were obtained from published literature , the Multicenter Randomized Clinical Trial of Endovascular Therapy for Acute Ischemic Stroke in the Netherlands ( MR CLEAN ) study , and claims databases in the United States .
METHODS	Health outcomes were measured in quality-adjusted life years ( QALYs ) .
METHODS	Treatment benefit was assessed by calculating the cost per QALY gained .
METHODS	One-way and probabilistic sensitivity analyses were performed to estimate the overall uncertainty of model results .
RESULTS	The addition of intra-arterial therapy compared with standard treatment alone yielded a lifetime gain of 0.7 QALY for an additional cost of $ 9911 , which resulted in a cost of $ 14 137 per QALY .
RESULTS	Multivariable sensitivity analysis predicted cost-effectiveness ( $ 50 000 per QALY ) in 97.6 % of simulation runs .
CONCLUSIONS	Intra-arterial treatment after intravenous tissue-type plasminogen activator for patients with anterior circulation strokes within the 6-hour window is likely cost-effective .
CONCLUSIONS	From a societal perspective , increased investment in access to intra-arterial treatment for acute stroke may be justified .

###26080888
OBJECTIVE	To compare clinical and radiographic success rates of a modified primary root canal filling ( ingredients : zinc oxide-eugenol , iodoform and calcium hydroxide , MPRCF ) vs. zinc oxide-eugenol cement ( ZOE ) and calcium hydroxide/iodoform paste ( Vitapex ) in pulpectomized primary molars at the end of 6 and 12 months , and to evaluate the degradation of materials in the root canals and in apical area .
METHODS	In the study , 160 primary molars from 155 children ( the average age : 5.881.27 years ) that met the inclusion criteria were allocated to one of the three materials via block randomization .
METHODS	A two-visit pulpectomy was performed by an investigator .
METHODS	The clinical and radiographic diagnoses were blindly assessed by other two investigators .
RESULTS	At the end of 6 and 12 months , the ZOE and MPRCF success rates were 100 % both in clinical and radiographic evaluation .
RESULTS	The Vitapex group showed the clinical success of 100 % at the end of 6 months and 94.5 % at the end of 12 months .
RESULTS	Radiographic evaluation for the Vitapex group showed 80.4 % success at the end of 6 months and 60.7 % at the end of 12 months .
RESULTS	No statistically significant differences were noted at the end of 6 months in the three groups both in clinical and radiographic evaluation .
RESULTS	The success rates in clinical and radiographic evaluation at the end of 12 months for ZOE and MPRCF groups were not significantly different , and better than those for Vitapex group with statistically significant difference .
RESULTS	The completely resorb rate of excess extruded extraradicularly were 14.3 % , 100 % and 71.4 % for ZOE , Vitapex and MPRCF at the end of 12 months .
RESULTS	The rates of resorption of material at the same rate of the root were 5.8 % , 7.2 % and 40.9 % for ZOE , Vitapex and MPRCF at the end of 12 months .
CONCLUSIONS	MPRCF , a mixture of zinc oxide eugenol and iodoform with calcium hydroxide can be used as a root canal filling material in primary teeth , taking account of the success rate and resorbing at a similar rate with the roots of the primary teeth .

###25037182
OBJECTIVE	To evaluate the effectiveness of platelet-rich fibrin ( PRF ) in preventing the development of alveolar osteitis ( AO ) .
METHODS	In a double-blinded study , patients with bilateral impacted mandibular third molars underwent surgical extractions , with one socket receiving PRF and the other one serving as a control .
METHODS	The surgeon and patient were unaware of the study or control side .
METHODS	The predictor variable was the PRF application and was categorized as PRF and non-PRF .
METHODS	The outcome variable was the development of AO during the first postoperative week .
METHODS	Other study variables included age , gender , smoking status , irrigation volume , extraction difficulty , surgeon experience , and number of anesthetic cartridges .
METHODS	Data were analyzed using ( 2 ) and t tests , with the significance level set at a P value less than .05 .
RESULTS	Seventy-eight patients ( mean age , 25 yr ) underwent 156 impacted third molar surgeries .
RESULTS	The overall frequency of AO was 14.74 % for all surgeries .
RESULTS	The frequency of AO in the PRF group was significantly lower than in the non-PRF group ( odds ratio = 0.44 ; P < .05 ) .
CONCLUSIONS	Based on the results of the present study , PRF application may decrease the risk of AO development after mandibular third molar surgery .

###25091854
OBJECTIVE	The present study examined the effect of reducing sprint interval training ( SIT ) work-interval duration on increases in maximal and submaximal performance .
METHODS	Subjects ( n = 36 ) were assigned to one of three training groups : endurance training ( ET ; 60 min per session for weeks 1-2 , increasing to 75 min per session for weeks 3-4 ) , or sprint interval training consisting of either repeated 30 ( SIT 30 ) or 15 ( SIT 15 ) second all-out intervals ( starting with 4 bouts per session for weeks 1-2 , increasing to 6 intervals per session for weeks 3-4 ) .
METHODS	Training consisted of cycling 3 times per week for 4 weeks .
RESULTS	While there was a significant main effect of training on VOpeak such that VOpeak was elevated post-training , no significant difference was observed in the improvements observed between groups ( ET ~ 13 % , SIT 30-4 % , SIT 15-8 % ) .
RESULTS	A significant main effect of training was observed such that lactate threshold and critical power were higher during post-testing across all groups ( p < 0.05 ) .
RESULTS	There was a main effect of training ( p < 0.05 ) on Wingate peak power with no differences observed between groups at post-training .
CONCLUSIONS	Together , these results indicate that reducing SIT work-interval duration from 30 to 15 s had no impact on training-induced increases in aerobic or anaerobic power , or on increases in lactate threshold ( absolute ) and critical power .

###25586372
OBJECTIVE	This study aimed to test the hypothesis that the i-gel supraglottic airway device would fit the larynx and provide better sealing pressure if prewarmed to 42C relative to the device kept at room temperature in non-paralysed , sedated patients .
METHODS	A total of 74 adult patients were assigned to the warm ( i-gel prewarmed to 42C ; W group ; 37 patients ) or the control ( i-gel kept at room temperature ; C group ; 37 patients ) groups .
METHODS	Anaesthesia was induced with propofol and fentanyl .
METHODS	The i-gel was prewarmed to 42C for 30min before insertion in the W group , but kept at room temperature ( approximately 23C ) for the C group .
METHODS	The number of attempts made until successful insertion and sealing pressure were compared between the two groups .
RESULTS	Insertion was successful with one attempt in 35 cases each for the W and C groups .
RESULTS	Two attempts were needed in two cases for the W group and one case for the C group .
RESULTS	There was one failed attempt in the C group , but none in the W group .
RESULTS	None of the differences between the two groups were significant ( p = 0.51 ) .
RESULTS	Sealing pressure was slightly , but not significantly , higher in the W group than in the C group ( W group 22.66.1 cmH2O ; C group 20.76.1 cmH2O ; p = 0.15 ) .
CONCLUSIONS	Prewarming of the i-gel to 42C did not increase the success rate of insertion , nor did it significantly increase sealing pressure in anaesthetised , non-paralysed patients .
CONCLUSIONS	Our data suggest that we can keep the i-gel at room temperature for emergency airway management for non-paralysed , sedated patients .
BACKGROUND	University Medical Information Network , Japan 000012287 .

###25935433
BACKGROUND	Although exercise has multiple health benefits , relatively little attention has been paid to its potential therapeutic effects in those with asthma .
OBJECTIVE	To examine the effects of acute exercise on inflammation in physically inactive and active adults with asthma .
METHODS	Fourteen adults with asthma ( n = 6 physically inactive , n = 8 physically active ) completed ( 1 ) 30 minutes of moderate-intensity exercise on a treadmill and ( 2 ) 30 minutes of rest in random order , with 4 weeks between sessions .
METHODS	Exhaled nitric oxide ( eNO ) was measured before and after the intervention ( 0 , 0.5 , 1 , 2 , 4 , and 24 hours ) .
METHODS	Blood inflammatory mediators were measured before and after the intervention ( 0 , 2 , and 24 hours ) .
RESULTS	Physically inactive participants had a significant decrease in eNO 4 hours after exercise ( -4.8 ppb,-6 .4 to-0 .5 ppb , P = .028 ) , which was not observed in physically active participants ( P = .362 ) .
RESULTS	Interluekin-1 receptor antagonist increased in the physically inactive group 2 hours after exercise , with this increase strongly correlated with the decrease in eNO at 4 hours ( R = -0.685 , P = .007 ) and 24 hours ( R = -0.659 , P = .014 ) after exercise .
RESULTS	Interleukin-6 was increased significantly 2 hours after exercise in physically inactive participants .
RESULTS	Blood neutrophils and nuclear factor erythroid 2-like 2 gene expression were increased 2hours after exercise in the overall cohort .
CONCLUSIONS	This study demonstrates that acute moderate-intensity exercise is associated with decreased eNO in physically inactive adults with asthma and suggests that interluekin-1 receptor antagonist could have a role in mediating this effect .
CONCLUSIONS	The attenuated response in physically active participants might be due to the sustained anti-inflammatory effects of exercise training .
CONCLUSIONS	Future studies should investigate the impact of exercise intensity and exercise training on airway inflammation in those with asthma .
BACKGROUND	Australian New Zealand Clinical Trials Registry ( http://www.anzctr.org.au ) , registration number ACTRN12613001014741 .

###24299019
OBJECTIVE	To test the effect of atorvastatin ( ATV ) and ATV plus -3 FAEEs on VLDL-TG metabolism in obese , insulin resistant men .
METHODS	We carried out a 6-week randomized , placebo-controlled study to examine the effect of ATV ( 40mg/day ) and ATV plus -3 FAEEs ( 4g/day ) on VLDL-TG metabolism in 36 insulin resistant obese men .
METHODS	VLDL-TG kinetics were determined using d5 - glycerol , gas chromatography-mass spectrometry and compartmental modelling .
RESULTS	Compared with the placebo , ATV significantly decreased VLDL-TG concentration ( -40 % , p < 0.001 ) by increasing VLDL-TG fractional catabolic rate ( FCR ) ( +47 % , p < 0.01 ) .
RESULTS	ATV plus -3 FAEEs lowered VLDL-TG concentration to a greater degree compared with placebo ( -46 % , p < 0.001 ) or ATV monotherapy ( -13 % , p = 0.04 ) .
RESULTS	This was achieved by a reduction in VLDL-TG production rate ( PR ) compared with placebo ( -32 % , p = 0.008 ) or ATV ( -20 % , p = 0.03 ) as well as a reciprocal increase in VLDL-TG FCR ( +42 % , p < 0.05 ) compared with placebo .
CONCLUSIONS	In insulin resistant , dyslipidaemic , obese men , ATV improves VLDL-TG metabolism by increasing VLDL-TG FCR .
CONCLUSIONS	The addition of 4g/day -3 FAEE to statin therapy provides further TG-lowering by lowering VLDL-TG PR .

###24615739
BACKGROUND	Conventional distillers dried grains with solubles ( DDGS-CV ) , uncooked distillers dried grains with solubles ( DDGS-BPX ) and high-protein distillers dried grains ( HP-DDG ) are used in diets for pigs to provide protein and energy .
BACKGROUND	These ingredients may have different effects on body composition and energy retention .
BACKGROUND	Therefore , an experiment was conducted to determine effects of DDGS-CV , DDGS-BPX and HP-DDG on body composition and on retention of protein , lipids , and energy when fed to growing or finishing pigs .
RESULTS	The total organ weight was greater ( P < 0.05 ) for finishing pigs fed the HP-DDG diet than for finishing pigs fed the basal diet or the DDGS-CV diet .
RESULTS	Finishing pigs fed the DDGS-CV diet had greater ( P < 0.05 ) lipid gain than pigs fed the other diets , and the net energy ( NE ) for DDGS-CV was greater ( P < 0.05 ) than for DDGS-BPX , but the NE value of HP-DDG was not different from that of DDGS-CV or DDGS-BPX .
CONCLUSIONS	Inclusion of up to 30 % DDGS or HP-DDG in diets fed to growing or finishing pigs will not affect body composition or the retention of energy , protein and lipids , regardless of the stage of growth of pigs .
CONCLUSIONS	The NE value of DDGS-BPX and HP-DDG is not affected by the stage of growth of pigs , but the NE value of DDGS-CV is greater in finishing than in growing pigs .

###24374513
OBJECTIVE	To test by randomized prospective multicenter trial the hypothesis that pancreaticoduodenectomy ( PD ) without the use of intraperitoneal drainage does not increase the frequency or severity of complications .
BACKGROUND	Some surgeons have abandoned the use of drains placed during pancreas resection .
METHODS	We randomized 137 patients to PD with ( n = 68 , drain group ) and without ( n = 69 , no-drain group ) the use of intraperitoneal drainage and compared the safety of this approach and spectrum of complications between the 2 groups .
RESULTS	There were no differences between drain and no-drain cohorts in demographics , comorbidities , pathology , pancreatic duct size , pancreas texture , baseline quality of life , or operative technique .
RESULTS	PD without intraperitoneal drainage was associated with an increase in the number of complications per patient [ 1 ( 0-2 ) vs 2 ( 1-4 ) , P = 0.029 ] ; an increase in the number of patients who had at least 1 grade 2 complication [ 35 ( 52 % ) vs 47 ( 68 % ) , P = 0.047 ] ; and a higher average complication severity [ 2 ( 0-2 ) vs 2 ( 1-3 ) , P = 0.027 ] .
RESULTS	PD without intraperitoneal drainage was associated with a higher incidence of gastroparesis , intra-abdominal fluid collection , intra-abdominal abscess ( 10 % vs 25 % , P = 0.027 ) , severe ( grade 2 ) diarrhea , need for a postoperative percutaneous drain , and a prolonged length of stay .
RESULTS	The Data Safety Monitoring Board stopped the study early because of an increase in mortality from 3 % to 12 % in the patients undergoing PD without intraperitoneal drainage .
CONCLUSIONS	This study provides level 1 data , suggesting that elimination of intraperitoneal drainage in all cases of PD increases the frequency and severity of complications .

###24779562
OBJECTIVE	To investigate the association of characteristics of type 2 diabetes mellitus ( duration and biochemical severity of diabetes ) to brain structure measured on magnetic resonance ( MR ) images , specifically testing whether more severity in metrics of diabetes is inversely correlated with brain volumes and positively correlated with ischemic lesion volumes .
METHODS	This study protocol was approved by the institutional review board of each center and participants provided written informed consent .
METHODS	Baseline severity of diabetes was evaluated by testing fasting plasma glucose levels , hemoglobin A1c levels , and duration of diabetes .
METHODS	MR imaging was performed with fluid-attenuated inversion recovery , proton-density , T2-weighted , and T1-weighted sequences , which were postprocessed with an automated computer algorithm that classified brain tissue as gray or white matter and as normal or ischemic .
METHODS	Separate linear regression models adjusted for potential confounding factors were used to investigate the relationship of the diabetes measures to MR imaging outcomes in 614 participants ( mean age , 62 years ; mean duration of type 2 diabetes mellitus , 9.9 years ) .
RESULTS	The mean volumes of total gray matter ( 463.9 cm ( 3 ) ) and total white matter ( 463.6 cm ( 3 ) ) were similar .
RESULTS	The mean volume of abnormal tissue was 2.5 cm ( 3 ) , mostly in the white matter ( 81 % white matter , 5 % gray matter , 14 % deep gray and white matter ) .
RESULTS	Longer duration of diabetes and higher fasting plasma glucose level were associated with lower normal ( = -0.431 and -0.053 , respectively ; P < .01 ) and total gray matter volumes ( = -0.428 and -0.053 , respectively ; P < .01 ) .
RESULTS	Fasting plasma glucose was also inversely correlated with ischemic lesion volume ( = -0.006 ; P < .04 ) .
RESULTS	Hemoglobin A1c level was not associated with any MR imaging measure .
CONCLUSIONS	Longer duration of diabetes is associated with brain volume loss , particularly in the gray matter , possibly reflecting direct neurologic insult ; biochemical measures of glycemia were less consistently related to MR imaging changes .
CONCLUSIONS	Contrary to common clinical belief , in this sample of patients with type 2 diabetes mellitus , there was no association of diabetes characteristics with small vessel ischemic disease in the brain .

###24423369
BACKGROUND	Although autologous bone marrow cell ( BMC ) therapy has emerged as a promising treatment for acute myocardial infarction ( AMI ) , trials reported mixed results .
BACKGROUND	In the BONAMI trial , active smoking reduced cardiac function recovery after reperfused AMI .
BACKGROUND	Therefore , we hypothesized that variability in the functionality of BMCs retrieved from patients with cardiovascular risk factors may partly explain these mixed results .
BACKGROUND	We investigated the characteristics of progenitor cells in active smokers and non-smokers with AMI and their potential impact on BMC therapy efficacy .
METHODS	Bone marrow and blood samples from 54 smoking and 47 non-smoking patients enrolled in the BONAMI cell therapy trial were analyzed .
RESULTS	The white BMC and CD45dimCD34 + cell numbers were higher in active smokers ( P = 0.001 , P = 0.03 , respectively ) .
RESULTS	In marked contrast , either bone marrow or blood endothelial progenitor CD45dimCD34 + KDR + cells ( EPCs ) were decreased in active smokers ( P = 0.005 , P = 0.04 , respectively ) .
RESULTS	Importantly , a multivariate analysis including cardiovascular risk factors confirmed the association between active smoking and lower EPC number in bone marrow ( P = 0.04 ) and blood ( P = 0.04 ) .
RESULTS	Furthermore , baseline circulating EPC count predicted infarct size decrease at three months post-AMI in non-smokers ( P = 0.01 ) but not in active smokers .
RESULTS	Interestingly , baseline circulating EPCs were no longer predictive of cardiac function improvement in the BMC therapy group .
CONCLUSIONS	These data suggest that circulating EPCs play an important role in cardiac repair post-AMI only in non-smokers and that active smoking-associated EPC alterations may participate in the impairment of cardiac function recovery observed in smokers after AMI , an effect that was overridden by BMC therapy .

###24284453
BACKGROUND	Rhythmic auditory stimulation ( RAS ) improves gait velocity , cadence , and stride length in hemiplegic stroke patients , yet little is known about the effectiveness of RAS on standing balance .
OBJECTIVE	To examine and compare the effectiveness on standing balance and gait parameter of two different types of gait trainings , gait training with RAS versus gait training without RAS , was compared in two groups of hemiplegic stroke patients over a three-week period ( RAS group , n = 8 ; control group = 8 ) .
METHODS	Sixteen hemiplegic stroke patients were included in the study .
METHODS	Standing balance was measured by using Biosway .
METHODS	Stride length , gait velocity , and cadence were calculated from the number of steps and required time for a 10 m-walk .
RESULTS	Pre - to post-test measures showed a significant improvement in RAS group for overall stability index ( p = 0.043 ) , mediolateral index ( p = 0.006 ) , anteroposterior index ( p = 0.016 ) , gait velocity ( p = 0.012 ) , stride length ( p = 0.03 ) and cadence ( p = 0.012 ) over the control group .
CONCLUSIONS	The results of this study showed that RAS was an effective therapeutic method to improve gait velocity , stride length , cadence , and standing balance in hemiplegic stroke patients .

###24442886
OBJECTIVE	The osteoclast has been implicated in development of bone erosion in gout .
OBJECTIVE	The aim of this study was to determine whether zoledronate , a potent antiosteoclast drug , influences bone erosion in people with tophaceous gout .
METHODS	This was a 2-year , randomised , double-blind , placebo-controlled trial of 100 people with tophaceous gout .
METHODS	Participants were randomised to annual administration of 5 mg intravenous zoledronate or placebo .
METHODS	The primary endpoint was change in the foot CT bone erosion score from baseline .
METHODS	Secondary endpoint was change in plain radiographic damage scores .
METHODS	Other endpoints were change in bone mineral density ( BMD ) , bone turnover markers and the OMERACT-endorsed core domains for chronic gout studies .
RESULTS	There was no change in CT erosion scores over 2 years , and no difference between the two treatment groups at Year 1 or 2 ( p ( treat ) = 0.10 , p ( time ) = 0.47 , p ( treat * time ) = 0.23 ) .
RESULTS	Similarly , there was no change in plain radiographic scores over 2 years , and no difference between the two groups at Year 1 or 2 .
RESULTS	By contrast , zoledronate increased spine , neck of femur , total hip and total body BMD .
RESULTS	Zoledronate therapy also reduced the bone turnover markers P1NP and - CTX compared with placebo .
RESULTS	There was no difference between treatment groups in OMERACT-endorsed core domains .
CONCLUSIONS	Despite improvements in BMD and suppression of bone turnover markers , antiosteoclast therapy with zoledronate did not influence bone erosion in people with tophaceous gout .
CONCLUSIONS	These findings suggest a disconnect between responses in the healthy skeleton and at sites of focal bone erosion in tophaceous gout .

###25818925
OBJECTIVE	To characterize anatomic and visual outcomes in patients with full-thickness macular hole ( FTMH ) at baseline in ocriplasmin phase 3 clinical trials , focusing on the relationship between resolution of vitreomacular adhesion and FTMH closure .
METHODS	Two multicenter , randomized , double-masked clinical trials .
METHODS	Pharmacologic FTMH closure was one of multiple secondary endpoints .
METHODS	OCT scans were obtained at baseline and at all postinjection visits , and for patients with baseline FTMH , evaluated for FTMH width , vitreomacular adhesion , and epiretinal membrane .
RESULTS	FTMH closure was observed in a greater proportion of ocriplasmin - vs vehicle-injected patients with baseline FTMH width 250 m ( 58.3 % vs 16.0 % , P < .001 ) and > 250 to 400 m ( 36.8 % vs 5.3 % , P = .009 ) .
RESULTS	Among FTMH patients in the ocriplasmin group , 2-line visual acuity gains at month 6 were achieved by a greater percentage of those who achieved hole closure at day 28 vs those who did not achieve this outcome ( 72.1 % vs 25.4 % ) .
CONCLUSIONS	Ocriplasmin demonstrated efficacy in closure of small and medium FTMH , and in FTMH without epiretinal membrane at baseline .
CONCLUSIONS	Visual acuity gains occurred more frequently when hole closure was achieved after ocriplasmin treatment compared to when this outcome did not occur .
CONCLUSIONS	Ocriplasmin treatment is an additional option for the management of patients with FTMH and vitreomacular adhesion .

###24861696
BACKGROUND	Etanercept ( ETN ) 50mg once weekly ( QW ) or 50mg twice weekly ( BIW ) for 12weeks , followed by 50mg QW in all subjects to Week 24 improved psoriasis in patients with concomitant psoriatic arthritis in the PRESTA trial .
OBJECTIVE	To use data from PRESTA to evaluate the effect of ETN in the treatment of psoriasis by Psoriasis Area Severity Index ( PASI ) body-region and component , and determine if PASI responses correlate with the Dermatology Life Quality Index ( DLQI ) .
METHODS	Median time to 75 % improvement in PASI ( PASI75 ) , body - and component-specific subscales over 24weeks were estimated .
METHODS	Pearson correlation coefficients determined the association between DLQI score and PASI total score , body - and component-specific subscales with ETN treatment at baseline and up to Week 24 .
RESULTS	In total , 748 patients from PRESTA were included ( ETN 50mg QW/QW , n = 371 ; BIW/QW , n = 377 ) .
RESULTS	Patients achieved PASI75 total score and 75 % improvements in all body regions and components faster on ETN 50mg BIW/QW than QW/QW ( all P < 005 ) .
RESULTS	Median time to 75 % improvement was faster for the head and trunk followed by upper and lower extremities , and for induration and desquamation followed by erythema and total area .
RESULTS	Weak to moderately positive correlations between improvements in DLQI and PASI total score ( r = 0223-0463 ) , all PASI body-specific ( r = 0114-0432 ) and component-specific ( r = 0178-0478 ) subscales were observed over 24weeks .
CONCLUSIONS	Etanercept treatment-response appears to occur in a body - and component-specific manner .
CONCLUSIONS	Changes in quality of life are not captured by PASI or its subscales .

###25200644
OBJECTIVE	To determine whether spinal anesthesia blunts surgical stress reactions and results in less perioperative hyperglycemia .
METHODS	Prospective , randomized controlled study .
METHODS	Operating room of a university hospital .
METHODS	68 adult , nondiabetic ( n = 40 ) and diabetic ( n = 28 ) , ASA physical status 1 , 2 , and 3 patients patients undergoing elective total hip replacement .
METHODS	General or spinal anesthesia was administered .
METHODS	Blood HbA1C was measured preoperatively to identify patients with undiagnosed diabetes .
METHODS	Glucose levels were checked preoperatively , then immediately after , and one hour after surgery .
METHODS	A conventional glucose control protocol was used , where insulin was given when blood glucose concentrations exceeded 250 mg/dL .
RESULTS	Preoperative glucose levels in general and spinal anesthesia patients were comparable and not significantly different in nondiabetic and diabetic patients .
RESULTS	At the end of surgery and one hour after surgery , glucose levels were significantly higher in patients undergoing general anesthesia compared with baseline values in both diabetic and nondiabetic patients ( P < 0.05 ) .
RESULTS	In nondiabetic and diabetic patients , a significant increase in glucose level was found in patients undergoing general anesthesia versus spinal anesthesia ( P < 0.05 ) .
RESULTS	In patients receiving spinal anesthesia , glucose levels remained stable .
RESULTS	Two diabetic patients undergoing general anesthesia received insulin .
CONCLUSIONS	Spinal anesthesia attenuates the hyperglycemic response to surgical stimuli in diabetics and nondiabetic patients .

###24495314
OBJECTIVE	For patient convenience , a gemigliptin/metformin sustainedrelease fixed-dose combination ( FDC ) tablet was developed .
OBJECTIVE	This study was conducted to investigate the effects of food on the pharmacokinetic ( PK ) profile of the FDC tablets .
METHODS	This was an open-label , randomized , single dose , 2-period , 2-sequence crossover study in 24 healthy male volunteers .
METHODS	The FDC tablets ( 25/500 mg 2 tablets ) were administered in high-fat fed and fasted states on separate occasions , and each subject was randomly allocated to each sequence with a 7-day washout period .
METHODS	PK blood samplings were conducted from predose to 48 hours after dosing .
METHODS	Tolerability assessments were performed throughout the study .
RESULTS	Nine adverse events ( AEs ) of mild intensity were reported from 8 subjects after study drug administration , and the AE frequency was similar between treatments .
RESULTS	No serious AEs were reported .
RESULTS	The PK parameters of gemigliptin and metformin were compared between fasting and fed states .
RESULTS	For gemigliptin , the geometric mean ratios ( GMRs ) ( fed : fasted state ) of the Cmax and AUClast were 0.886 ( 90 % confidence interval ( CI ) 0.781 - 1.006 ) and 1.021 ( 90 % CI 0.949 - 1.099 ) , respectively .
RESULTS	For metformin , the GMRs of the Cmax and AUClast were 0.811 ( 90 % CI 0.712 - 0.923 ) and 1.144 ( 90 % CI 1.013 - 1.291 ) , respectively .
RESULTS	A prolonged tmax for metformin was observed .
RESULTS	These results are similar to the effects of food on each component .
CONCLUSIONS	The FDC tablet may have a similar PK profile as that of individual drugs and is generally tolerable when administered with food .
CONCLUSIONS	These results indicate that the FDC tablet can be administered in the same dosing regimen as each component , especially that of metformin sustained-release .

###25785969
BACKGROUND	Pneumococcal polysaccharide conjugate vaccines prevent pneumococcal disease in infants , but their efficacy against pneumococcal community-acquired pneumonia in adults 65 years of age or older is unknown .
METHODS	In a randomized , double-blind , placebo-controlled trial involving 84,496 adults 65 years of age or older , we evaluated the efficacy of 13-valent polysaccharide conjugate vaccine ( PCV13 ) in preventing first episodes of vaccine-type strains of pneumococcal community-acquired pneumonia , nonbacteremic and noninvasive pneumococcal community-acquired pneumonia , and invasive pneumococcal disease .
METHODS	Standard laboratory methods and a serotype-specific urinary antigen detection assay were used to identify community-acquired pneumonia and invasive pneumococcal disease .
RESULTS	In the per-protocol analysis of first episodes of infections due to vaccine-type strains , community-acquired pneumonia occurred in 49 persons in the PCV13 group and 90 persons in the placebo group ( vaccine efficacy , 45.6 % ; 95.2 % confidence interval [ CI ] , 21.8 to 62.5 ) , nonbacteremic and noninvasive community-acquired pneumonia occurred in 33 persons in the PCV13 group and 60 persons in the placebo group ( vaccine efficacy , 45.0 % ; 95.2 % CI , 14.2 to 65.3 ) , and invasive pneumococcal disease occurred in 7 persons in the PCV13 group and 28 persons in the placebo group ( vaccine efficacy , 75.0 % ; 95 % CI , 41.4 to 90.8 ) .
RESULTS	Efficacy persisted throughout the trial ( mean follow-up , 3.97 years ) .
RESULTS	In the modified intention-to-treat analysis , similar efficacy was observed ( vaccine efficacy , 37.7 % , 41.1 % , and 75.8 % , respectively ) , and community-acquired pneumonia occurred in 747 persons in the PCV13 group and 787 persons in placebo group ( vaccine efficacy , 5.1 % ; 95 % CI , -5.1 to 14.2 ) .
RESULTS	Numbers of serious adverse events and deaths were similar in the two groups , but there were more local reactions in the PCV13 group .
CONCLUSIONS	Among older adults , PCV13 was effective in preventing vaccine-type pneumococcal , bacteremic , and nonbacteremic community-acquired pneumonia and vaccine-type invasive pneumococcal disease but not in preventing community-acquired pneumonia from any cause .
CONCLUSIONS	( Funded by Pfizer ; CAPITA ClinicalTrials.gov number NCT00744263 . )

###24443392
OBJECTIVE	Large for gestational age infants are at increased risk of childhood obesity and maternal nutrition impacts birthweight .
OBJECTIVE	The aim of this study was to assess the impact of a maternal low glycaemic index ( GI ) diet on neonatal anthropometry .
METHODS	The ROLO ( Randomised Control Trial of Low Glycaemic Index Diet in Pregnancy ) study was a randomized controlled trial to assess the impact of a low GI diet versus usual diet on birthweight .
METHODS	It took place in a tertiary maternity hospital in Ireland and women were randomized to receive either a low GI diet or no dietary intervention from early pregnancy to term .
METHODS	Two hundred sixty-five neonates had anthropometric measurements on day 1-2 of life , 126 in the intervention group and 139 in the control group .
METHODS	Measurements included birthweight , length and circumferences of the head , chest , abdominal , thigh and mid-upper arm .
METHODS	A subgroup of 219 ( 82 % ) neonates also had skin-fold measurements .
RESULTS	Neonates whose mothers had a low GI diet in pregnancy had lower thigh circumference ( 15.91.7 cm vs. 16.61.5 cm , P = 0.04 ) .
RESULTS	There was no difference between the intervention and control groups in head , chest abdominal or mid-upper arm circumferences .
RESULTS	No difference was noted between the two groups for any skin-fold measurements ( subscapular , thigh , biceps and triceps ) .
CONCLUSIONS	Neonatal thigh circumference was altered by maternal low GI diet in pregnancy .
CONCLUSIONS	These findings suggest that maternal low GI diet is safe in pregnancy and may positively impact infant adiposity .

###24315218
OBJECTIVE	The aim of this study is to assess the effect of brief motivational enhancement intervention postpartum alcohol use .
METHODS	This study is a single-blinded , randomized controlled effectiveness trial in which pregnant women were assigned to receive usual care or up to 5 face-to-face brief motivational enhancement sessions lasting 10-30 minutes each and occurring at study enrollment , 4 and 8 weeks after enrollment , 32 weeks of gestation , and 6 weeks postpartum .
METHODS	The setting is in a large , urban , obstetrics clinic .
METHODS	Participants were women who were 18 years old , < 20 weeks of gestation , and consumed alcohol during pregnancy .
METHODS	Of 3438 women screened , 330 eligible women were assigned to usual care ( n = 165 ) or intervention ( n = 165 ) .
METHODS	Due to missing data , we analyzed 125 in the intervention group and 126 in the usual care group .
METHODS	The measurements were the proportion of women with any alcohol use and the number of drinks per day , reported via follow-up telephone interviews at 4 and 8 weeks after enrollment , 32 weeks of gestation , and 6 weeks , 6 months , and 12 months postpartum .
RESULTS	In random effects models adjusted for confounders , the intervention group was less likely to use any alcohol ( odds ratio 0.50 ; 95 % confidence interval [ CI ] , 0.23-1 .09 ; P = 0.08 ) and consumed fewer drinks per day ( coefficient -0.11 ; 95 % CI -0.23 -0.01 ; P = 0.07 ) than , the usual care group in the postpartum period but these differences were non-significant .
RESULTS	Missing data during the prenatal period prevented us from modeling prenatal alcohol use .
CONCLUSIONS	Brief motivational enhancement intervention delivered in an obstetrical outpatient setting did not conclusively decrease alcohol use during the postpartum period .

###25245446
OBJECTIVE	A randomized clinical trial compared efficacy and toxicity of standard all-trans-retinoic acid ( ATRA ) plus chemotherapy versus ATRA plus arsenic trioxide in patients with newly diagnosed , low - or intermediate-risk acute promyelocytic leukemia ( APL ) .
OBJECTIVE	Here , we report health-related quality-of-life ( HRQOL ) results .
METHODS	HRQOL was a secondary end point of this trial .
METHODS	The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 was used to assess HRQOL at end of induction and after consolidation therapy .
METHODS	All analyses were based on 156 patients who received at least one dose of treatment , with groups defined according to randomly assigned treatment .
METHODS	Primary analysis was performed , estimating mean HRQOL score over time and differences between treatment arms using a linear mixed model .
RESULTS	Overall , 162 patients age 18 to 70 years were enrolled .
RESULTS	Of these , 150 and 142 patients were evaluable for HRQOL after induction therapy and third consolidation course , respectively .
RESULTS	Overall compliance with HRQOL forms was 80.1 % .
RESULTS	The largest difference , favoring patients treated with ATRA plus arsenic trioxide , was found for fatigue severity ( mean score difference , -9.3 ; 95 % CI , -17.8 to -0.7 ; P = .034 ) at end of induction therapy .
RESULTS	This difference was also clinically relevant .
RESULTS	HRQOL differences between treatment arms at end of consolidation showed that for several scales , differences between treatment arms were marginal .
CONCLUSIONS	Overall , current HRQOL findings further support the use of ATRA plus arsenic trioxide as preferred first-line treatment in patients with low - or intermediate-risk APL .

###25481088
BACKGROUND	The anterior cruciate ligament ( ACL ) is one of four major ligaments in the knee that provide stability during physical activity .
BACKGROUND	A tear in the ACL is characterized by joint instability that leads to decreased activity , knee dysfunction , reduced quality of life and a loss of muscle mass and strength .
BACKGROUND	While rehabilitation is the standard-of-care for return to daily function , additional surgical reconstruction can provide individuals with an opportunity to return to sports and strenuous physical activity .
BACKGROUND	Over 200,000 ACL reconstructions are performed in the United States each year , and rehabilitation following surgery is slow and expensive .
BACKGROUND	One possible method to improve the recovery process is the use of intramuscular testosterone , which has been shown to increase muscle mass and strength independent of exercise .
BACKGROUND	With short-term use of supraphysiologic doses of testosterone , we hope to reduce loss of muscle mass and strength and minimize loss of physical function following ACL reconstruction compared to standard-of-care alone .
METHODS	This study is a double-blinded randomized control trial .
METHODS	Men 18-50 years of age , scheduled for ACL reconstruction are randomized into two groups .
METHODS	Participants randomized to the testosterone group receive intramuscular testosterone administration once per week for 8 weeks starting 2 weeks prior to surgery .
METHODS	Participants randomized to the control group receive a saline placebo intramuscularly instead of testosterone .
METHODS	Lean mass , muscle strength and physical function are measured at 5 time points : 2 weeks pre-surgery , 1 day pre-surgery , and 6 , 12 , 24 weeks post-surgery .
METHODS	Both groups follow standard-of-care rehabilitation protocol .
CONCLUSIONS	We believe that testosterone therapy will help reduce the loss of muscle mass and strength experienced after ACL injury and reconstruction .
CONCLUSIONS	Hopefully this will provide a way to shorten the rehabilitation necessary following ACL reconstruction .
CONCLUSIONS	If successful , testosterone therapy may also be used for other injuries involving trauma and muscle atrophy .
BACKGROUND	NCT01595581 , REGISTRATION : May 8 , 2012 .

###25726502
BACKGROUND	In most countries , alteplase given within 45 h of onset is the only approved medical treatment for acute ischaemic stroke .
BACKGROUND	The newer thrombolytic drug tenecteplase has been investigated in one randomised trial up to 3 h after stroke and in another trial up to 6 h after stroke in patients selected by advanced neuroimaging .
BACKGROUND	In the Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis ( ATTEST ) , we aimed to assess the efficacy and safety of tenecteplase versus alteplase within 45 h of stroke onset in a population not selected on the basis of advanced neuroimaging , and to use imaging biomarkers to inform the design of a definitive phase 3 clinical trial .
METHODS	In this single-centre , phase 2 , prospective , randomised , open-label , blinded end-point evaluation study , adults with supratentorial ischaemic stroke eligible for intravenous thrombolysis within 45 h of onset were recruited from The Institute of Neurological Sciences , Glasgow , Scotland .
METHODS	Patients were randomly assigned ( 1:1 ) to receive tenecteplase 025 mg/kg ( maximum 25 mg ) or alteplase 09 mg/kg ( maximum 90 mg ) .
METHODS	Treatment allocation used a mixed randomisation and minimisation algorithm including age and National Institutes of Health Stroke Scale score , generated by an independent statistician .
METHODS	Patients were not informed of treatment allocation ; treating clinicians were aware of allocation but those assessing the primary outcome were not .
METHODS	Imaging comprised baseline CT , CT perfusion , and CT angiography ; and CT plus CT angiography at 24-48 h.
METHODS	The primary endpoint was percentage of penumbra salvaged ( CT perfusion-defined penumbra volume at baseline minus CT infarct volume at 24-48 h ) .
METHODS	Analysis was per protocol .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01472926 .
RESULTS	Between Jan 1 , 2012 , and Sept 7 , 2013 , 355 patients were screened , of whom 157 were eligible for intravenous thrombolysis , and 104 patients were enrolled .
RESULTS	52 were assigned to the alteplase group and 52 to tenecteplase .
RESULTS	Of 71 patients ( 35 assigned tenecteplase and 36 assigned alteplase ) contributing to the primary endpoint , no significant differences were noted for percentage of penumbral salvaged ( 68 % [ SD 28 ] for the tenecteplase group vs 68 % [ 23 ] for the alteplase group ; mean difference 13 % [ 95 % CI -96 to 121 ] ; p = 081 ) .
RESULTS	Neither incidence of symptomatic intracerebral haemorrhage ( by SITS-MOST definition , 1/52 [ 2 % ] tenecteplase vs 2/51 [ 4 % ] alteplase , p = 055 ; by ECASS II definition , 3/52 [ 6 % ] vs 4/51 [ 8 % ] , p = 059 ) nor total intracerebral haemorrhage events ( 8/52 [ 15 % ] vs 14/51 [ 29 % ] , p = 0091 ) differed significantly .
RESULTS	The incidence of serious adverse events did not differ between groups ( 32 in the tenecteplase group , three considered probably or definitely related to drug treatment ; 16 in the alteplase group , five were considered drug-related ) .
CONCLUSIONS	Neurological and radiological outcomes did not differ between the tenecteplase and alteplase groups .
CONCLUSIONS	Evaluation of tenecteplase in larger trials of patients with acute stroke seems warranted .
BACKGROUND	The Stroke Association .

###24668261
OBJECTIVE	This study evaluated whether harp therapy reduces levels of stress and improves clinical outcomes in patients undergoing embryo transfer .
METHODS	This prospective randomized trial enrolled 181 women undergoing embryo transfer , who were randomized to harp therapy during embryo transfer or standard treatment .
METHODS	Patients underwent standardized psychological testing and physiologic assessment of stress .
METHODS	The study was conducted in a reproductive medicine practice .
RESULTS	No statistically significant differences were found in the heart and respiratory rates , nor was there a significant difference in event-based anxiety at baseline .
RESULTS	Harp therapy had a significantly larger decrease in state anxiety from pre - to post-embryo transfer .
RESULTS	Clinical pregnancy was 53 % versus 48 % for the harp therapy and standard treatment groups , respectively .
CONCLUSIONS	Harp therapy decreases state , or event-based , anxiety , significantly lowering state scores posttransfer and having a positive effect on acute levels of stress .
CONCLUSIONS	There was an increased pregnancy rate , but larger sample sizes are needed to evaluate whether harp therapy has an effect on clinical outcomes .

###25801699
OBJECTIVE	Metastatic gastrointestinal stromal tumour ( GIST ) is generally an incurable disease with variable response to imatinib .
OBJECTIVE	We aimed to develop prognostic nomograms to predict overall survival ( OS ) and progression-free survival ( PFS ) for patients treated with imatinib .
METHODS	Nomograms were developed in a training cohort ( n = 330 ) of patients treated in a randomised trial ( EORTC-ISG-AGITG 62005 phase III study ) using Cox regression models , and validated in patients ( n = 236 ) treated in routine clinical care from six referral centres .
METHODS	Nomogram performance was assessed by calculating the c statistic .
METHODS	A classification based on the nomograms ' scores was generated to group patients according to risk .
RESULTS	Nomogram risk factors for OS and PFS were size of the largest metastasis , tumour genotype , primary tumour mitotic count , haemoglobin and blood neutrophil count at commencement of imatinib .
RESULTS	The nomograms predicted survival with a c statistic of 0.75 ( training ) and 0.62 ( validation ) for OS , and 0.69 ( training ) and 0.62 ( validation ) for PFS .
RESULTS	When tested in the validation cohort , the nomograms discriminated well the high and intermediate risk from low risk patients ( hazard ratio [ HR ] for OS 3.83 , 95 % confidence interval [ CI ] 1.71-8 .56 ; and 2.48 , 95 % CI 1.12-5 .50 ; for PFS 2.84 , 95 % CI 1.66-4 .87 ; and 1.45 , 95 % CI 0.87-2 .41 , respectively ) .
CONCLUSIONS	The nomograms predicted the risk of GIST progression and death with good discrimination of risk groups , and may be of value for patient counselling and risk stratification .

###26033286
BACKGROUND	Health-related quality of life ( HRQoL ) was an exploratory endpoint in the PALETTE trial , a global , double-blind , randomized , phase 3 trial of pazopanib 800 mg versus placebo as second-line or later treatment for patients with advanced soft tissue sarcoma ( N = 369 ) .
BACKGROUND	In that trial , progression-free survival was significantly improved in the pazopanib arm ( median , 4.6 vs 1.6 months ; hazard ratio , 0.31 ; P < .001 ) , and toxicity of pazopanib consisted mainly of fatigue , diarrhea , nausea , weight loss , and hypertension .
METHODS	HRQoL was assessed using the 30-item core European Organization for the Research and Treatment of Cancer ( EORTC ) Quality-of-Life Questionnaire ( EORTC QLQ-C30 ) at baseline and at weeks 4 , 8 , and 12 in patients who received treatment on protocol .
METHODS	The primary HRQoL endpoint was the EORTC QLQ-C30 global health status scale .
RESULTS	Compliance with HRQoL assessments was good , ranging from 94 % at baseline to 81 % at week 12 .
RESULTS	Differences in scores on the EORTC QLQ-C30 global health status subscale between the 2 treatment arms were not statistically significant and did not exceed the predetermined , minimal clinically important difference of 10 points ( P = .291 ; maximum difference , 3.8 points ) .
RESULTS	Among the other subscales , the pazopanib arm reported significantly worse symptom scores for diarrhea ( P < .001 ) loss of appetite ( P < .001 ) , nausea/vomiting ( P < .001 ) , and fatigue ( P = .012 ) .
RESULTS	In general , HRQoL scores tended to decline over time in both arms .
CONCLUSIONS	HRQoL did not improve with the receipt of pazopanib .
CONCLUSIONS	However , the observed improvement in progression-free survival without impairment of HRQoL was considered a meaningful result .
CONCLUSIONS	The toxicity profile of pazopanib was reflected in the patients ' self-reported symptoms but did not translate into significantly worse overall global health status during treatment .

###25171115
BACKGROUND	More than 20 % of patients develop chronic instability following appropriate management of an ` ankle sprain ' .
BACKGROUND	There is little research comparing surgical techniques .
BACKGROUND	` Anatomical ' procedures , such as the modified Brostrom-Gould ( MBG ) , are generally preferred .
BACKGROUND	However , not all patients are suitable for this procedure .
BACKGROUND	Augmentation of a primary repair using a synthetic ligament , such as the ligament augmentation reconstruction system ( LARS ) , is another ` anatomic ' option .
BACKGROUND	Our objective was to compare the clinical outcome following the MBG with that following the LARS technique using a prospective randomized clinical trial .
METHODS	Patients who satisfied the study criteria were randomly allocated to undergo the LARS procedure or the MBG procedure .
METHODS	All patients followed a similar rehabilitation programme .
METHODS	Patients completed the foot and ankle outcome score ( FAOS ) before surgery , and then at 1 year and 2 years following surgery .
METHODS	Statistical analysis was used to compare the groups ( P < 0.05 ) .
RESULTS	Forty-one patients took part in the study , 21 were randomized to the LARS group and 20 to the MBG group .
RESULTS	The LARS group had a significantly better improvement in the total FAOS at both 1 year ( 25.5 standard error ( SE ) 3.8 versus 16.0 SE 3.3 ) and 2 years ( 27.1 SE 4.5 versus 15.8 SE 4.9 ) post-surgery .
CONCLUSIONS	Primary repair combined with LARS results in better patient-scored clinical outcome , at 2 years post-surgery , than the MBG procedure .
CONCLUSIONS	Although longer follow-up is required , the LARS procedure may be considered as an alternative , especially in those patients for whom the MBG is relatively contra-indicated .

###25578869
BACKGROUND	Cetuximab based treatment is the recommended chemotherapy for head and neck squamous cell cancers in the palliative setting .
BACKGROUND	However , due to financial constraints , intravenous ( IV ) chemotherapy without cetuximab is commonly used in lesser developed countries .
BACKGROUND	We believe that oral metronomic chemotherapy may be safer and more effective in this setting .
METHODS	We conducted an open label , superiority , parallel design , randomized phase II trial comparing oral MCT [ daily celecoxib ( 200mg twice daily ) and weekly methotrexate ( 15mg/m ( 2 ) ) ] to intravenous single agent cisplatin ( IP ) ( 75mg/m ( 2 ) ) given 3 weekly .
METHODS	Eligible patients had head and neck cancers requiring palliative chemotherapy with ECOG PS 0-2 and adequate organ functions who could not afford cetuximab .
METHODS	The primary end point was progression-free survival .
RESULTS	110 Patients were recruited between July 2011 to May 2013 , 57 randomized to the MCT arm and 53 to the IP arm .
RESULTS	Patients in the MCT arm had significantly longer PFS ( median 101 days , 95 % CI : 58.2-143 .7 days ) compared to the IP arm ( median 66 days , 95 % CI ; 55.8-76 .1 days ) ( p = 0.014 ) .
RESULTS	The overall survival ( OS ) was also increased significantly in the MCT arm ( median 249 days , 95 % CI : 222.5-275 .5 days ) compared to the IP arm ( median 152 days , 95 % CI : 104.2-199 .8 days ) ( p = 0.02 ) .
RESULTS	There were fewer grade 3/4 adverse effects with MCT , which was not significant .
RESULTS	( 18.9 % vs. 31.4 % , P = 0.14 ) .
CONCLUSIONS	Oral metronomic chemotherapy has significantly better PFS and OS than single agent platinum in the palliative setting .

###24983993
BACKGROUND	Incisional hernia is one of the most frequent postoperative complications after abdominal surgery .
BACKGROUND	Patients with an abdominal aortic aneurysm and patients with a body mass index of 27 or higher have an increased risk to develop incisional hernia .
BACKGROUND	Primary mesh augmentation is a method in which the abdominal wall is strengthened to reduce incisional hernia incidence .
BACKGROUND	This study focused on the short-term results of the PRImary Mesh Closure of Abdominal Midline Wounds trial , a multicenter double blind randomized controlled trial .
METHODS	Between 2009 and 2012 patients were included if they were operated via midline laparotomy , and had an abdominal aortic aneurysm or a body mass index of 27 or higher .
METHODS	Patients were randomly assigned to either receive primary suture , onlay mesh augmentation ( OMA ) , or sublay mesh augmentation .
RESULTS	Outcomes represent results after 1-month follow-up .
RESULTS	A total of 480 patients were randomized .
RESULTS	During analysis , significantly ( P = 0.002 ) more seromas were detected after OMA ( n = 34 , 18.1 % ) compared with primary suture ( n = 5 , 4.7 % ) and sublay mesh augmentation ( n = 13 , 7 % ) .
RESULTS	No differences were discovered in any of the other outcomes such as surgical site infection , hematoma , reintervention , or readmission .
RESULTS	Multivariable analysis revealed an increase in seroma formation after OMA with an odds ratio of 4.3 ( P = 0.004 ) compared with primary suture and an odds ratio of 2.9 ( P = 0.003 ) compared with sublay mesh augmentation .
CONCLUSIONS	On the basis of these short-term results , primary mesh augmentation can be considered a safe procedure with only an increase in seroma formation after OMA , but without an increased risk of surgical site infection .

###25965710
BACKGROUND	Cardiovascular ( CV ) disease is the leading cause of morbidity and mortality in patients with type 2 diabetes mellitus ( T2DM ) .
BACKGROUND	Furthermore , patients with T2DM and acute coronary syndrome ( ACS ) have a particularly high risk of CV events .
BACKGROUND	The glucagon-like peptide 1 receptor agonist , lixisenatide , improves glycemia , but its effects on CV events have not been thoroughly evaluated .
METHODS	ELIXA ( www.clinicaltrials.gov no .
METHODS	NCT01147250 ) is a randomized , double-blind , placebo-controlled , parallel-group , multicenter study of lixisenatide in patients with T2DM and a recent ACS event .
METHODS	The primary aim is to evaluate the effects of lixisenatide on CV morbidity and mortality in a population at high CV risk .
METHODS	The primary efficacy end point is a composite of time to CV death , nonfatal myocardial infarction , nonfatal stroke , or hospitalization for unstable angina .
METHODS	Data are systematically collected for safety outcomes , including hypoglycemia , pancreatitis , and malignancy .
RESULTS	Enrollment began in July 2010 and ended in August 2013 ; 6,068 patients from 49 countries were randomized .
RESULTS	Of these , 69 % are men and 75 % are white ; at baseline , the mean SD age was 60.3 9.7 years , body mass index was 30.2 5.7 kg/m ( 2 ) , and duration of T2DM was 9.3 8.2 years .
RESULTS	The qualifying ACS was a myocardial infarction in 83 % and unstable angina in 17 % .
RESULTS	The study will continue until the positive adjudication of the protocol-specified number of primary CV events .
CONCLUSIONS	ELIXA will be the first trial to report the safety and efficacy of a glucagon-like peptide 1 receptor agonist in people with T2DM and high CV event risk .

###25144625
BACKGROUND	The Combined Aerobic and Resistance Exercise Trial tested different types and doses of exercise in breast cancer patients receiving chemotherapy .
BACKGROUND	Here , we explore potential moderators of the exercise training responses .
METHODS	Breast cancer patients initiating chemotherapy ( N = 301 ) were randomly assigned to three times a week , supervised exercise of a standard dose of 25-30 min of aerobic exercise , a higher dose of 50-60 min of aerobic exercise , or a higher dose of 50-60 min of combined aerobic and resistance exercise .
METHODS	Outcomes were patient-reported symptoms and health-related fitness .
METHODS	Moderators were baseline demographic , exercise/fitness , and cancer variables .
RESULTS	Body mass index moderated the effects of the exercise interventions on bodily pain ( P for interaction = 0.038 ) , endocrine symptoms ( P for interaction = 0.029 ) , taxane/neuropathy symptoms ( P for interaction = 0.013 ) , aerobic fitness ( P for interaction = 0.041 ) , muscular strength ( P for interaction = 0.007 ) , and fat mass ( P for interaction = 0.005 ) .
RESULTS	In general , healthy weight patients responded better to the higher-dose exercise interventions than overweight/obese patients .
RESULTS	Menopausal status , age , and baseline fitness moderated the effects on patient-reported symptoms .
RESULTS	Premenopausal , younger , and fitter patients achieved greater benefits from the higher-dose exercise interventions .
CONCLUSIONS	Healthy weight , fitter , and premenopausal/younger breast cancer patients receiving chemotherapy are more likely to benefit from higher-dose exercise interventions .

###24489072
OBJECTIVE	Implantable cardioverter-defibrillators ( ICDs ) treat ventricular tachycardia or fibrillation but may also deliver unnecessary shocks .
OBJECTIVE	We sought to determine if the frequency of ICD-detected non-sustained or diverted ( NSD ) episodes increases before appropriate or inappropriate ICD shocks .
RESULTS	We evaluated NSD episodes in the INTRINSIC RV Trial and their relationship to ICD shocks ( appropriate and inappropriate ) .
RESULTS	Time from NSD to shock was analysed .
RESULTS	Results were validated by utilizing 1495 adjudicated ICD and cardiac resynchronization therapy-defibrillator shocks following NSD episodes collected through the LATITUDE remote monitoring system as part of the ALTITUDE-REDUCES Study .
RESULTS	In INTRINSIC RV , 185 participants received 373 shocks ; 148 had at least 1 NSD episode .
RESULTS	Non-sustained or diverted frequency increased 24 h before the first shock for those receiving an inappropriate ( P < 0.01 ) but not an appropriate shock ( P = 0.17 ) .
RESULTS	Patients with NSD episodes within 24 h of a shock were significantly more likely to receive inappropriate therapy [ odds ratio ( OR ) = 3.12 , P < 0.01 ] .
RESULTS	At the receiver operator curve determined optimal cutoff , an NSD episode within 14 min before shock strongly predicted inappropriate therapy ( sensitivity 48 % , specificity 91 % ; OR = 8.8 , and P < 0.001 ) .
RESULTS	The 14 min cut-off evaluated on an independent dataset of 1495 shock episodes preceded by an NSD in the ALTITUDE-REDUCES Study confirmed these results ( sensitivity = 47 % , specificity = 85 % , OR = 5.0 , and P < 0.001 ) .
CONCLUSIONS	Device-detected NSD episodes increase before inappropriate but not appropriate shocks .
CONCLUSIONS	Novel alerts or automated algorithms based on NSD episodes may reduce inappropriate shocks .

###24746976
BACKGROUND	Nutritional interventions have shown increased energy intake but not improvement in health-related quality of life ( HRQL ) or prognosis in non small cell lung cancer ( NSCLC ) patients .
BACKGROUND	Eicosapentaenoic acid has been proposed to have anti-inflammatory , anticachectic and antitumoural effects .
OBJECTIVE	To compare the effect of an oral EPA enriched supplement with an isocaloric diet on nutritional , clinical and inflammatory parameters and HRQL in advanced NSCLC patients .
METHODS	Patients with advanced NSCLC were randomized to receive diet plus oral nutritional supplement containing EPA ( ONS-EPA ) or only isocaloric diet ( C ) .
METHODS	All patients received paclitaxel and cisplatin/carboplatin treatment .
METHODS	Weight , body composition , dietary intake , inflammatory parameters and HRQL were assessed at baseline and after the first and second cycles of chemotherapy .
METHODS	Response to chemotherapy and survival were evaluated .
RESULTS	Ninety two patients were analysed ( 46 ONS-EPA ,46 C ) .
RESULTS	ONS-EPA group had significantly greater energy ( p < 0.001 ) and protein ( p < 0.001 ) intake compared with control .
RESULTS	Compared with baseline , patients receiving the ONS-EPA gained 1.65 kg of lean body mass ( LBM ) compared with a loss of-2 .06 kg in the control ( p = 0.01 ) .
RESULTS	Fatigue , loss of appetite and neuropathy decreased in the ONS-EPA group ( p0 .05 ) .
RESULTS	There was no difference in response rate or overall survival between groups .
CONCLUSIONS	Patients with NSCLC receiving ONS-EPA significantly improves energy and protein intake , body composition .
CONCLUSIONS	and decreased fatigue , loss of appetite and neuropathy .
CONCLUSIONS	Registered with ClinicalTrials.gov ( NCT01048970 ) .

###26116999
OBJECTIVE	To examine the influence of exercise intensity on postprandial health outcomes in adolescents when exercise is accumulated throughout the day .
METHODS	19 adolescents ( 9 male , 13.70.4 years old ) completed three 1-day trials in a randomised order : ( 1 ) rest ( CON ) ; or four bouts of ( 2 ) 21 min cycling at 90 % peak power with 75 s recovery ( high-intensity interval exercise ; HIIE ) ; or ( 3 ) cycling at 90 % of the gas exchange threshold ( moderate-intensity exercise ; MIE ) , which was work-matched to HIIE .
METHODS	Each bout was separated by 2 hours .
METHODS	Participants consumed a high fat milkshake for breakfast and lunch .
METHODS	Postprandial triacylglycerol ( TAG ) , glucose , systolic blood pressure ( SBP ) and fat oxidation were assessed throughout the day .
RESULTS	There was no effect of trial on total area under the curve ( TAUC ) for TAG ( P = 0.87 ) .
RESULTS	TAUC-glucose was lower in HIIE compared to CON ( P = 0.03 , ES = 0.42 ) and MIE ( P = 0.04 , ES = 0.41 ) , with no difference between MIE and CON ( P = 0.89 , ES = 0.04 ) .
RESULTS	Postprandial SBP was lower in HIIE compared to CON ( P = 0.04 , ES = 0.50 ) and MIE ( P = 0.04 , ES = 0.40 ) , but not different between MIE and CON ( P = 0.52 , ES = 0.11 ) .
RESULTS	Resting fat oxidation was increased in HIIE compared to CON ( P = 0.01 , ES = 0.74 ) and MIE ( P = 0.05 , ES = 0.51 ) , with no difference between MIE and CON ( P = 0.37 , ES = 0.24 ) .
CONCLUSIONS	Neither exercise trial attenuated postprandial lipaemia .
CONCLUSIONS	However , accumulating brief bouts of HIIE , but not MIE , reduced postprandial plasma glucose and SBP , and increased resting fat oxidation in adolescent boys and girls .
CONCLUSIONS	The intensity of accumulated exercise may therefore have important implications for health outcomes in youth .

###24220287
BACKGROUND	Malaria during pregnancy has serious consequences that are worsened by HIV infection .
BACKGROUND	Malaria preventive measures for HIV-infected pregnant women include cotrimoxazole ( CTX ) prophylaxis given to prevent HIV-related opportunistic infections and also protective against malaria , or intermittent preventive treatment ( IPTp ) with an antimalarial drug .
BACKGROUND	Here , we present the first study evaluating CTX efficacy versus mefloquine ( MQ ) - IPTp , alone and in combination , in HIV-infected pregnant women .
METHODS	We conducted 2 randomized , open-label , noninferiority trials in Benin .
METHODS	In the CTX-mandatory trial , HIV-infected women with CD4 counts of < 350 per cubic millimeter received CTX either alone or with MQ-IPTp ( N = 292 ) .
METHODS	In the CTX-not-mandatory trial ( CD4 count > 350/mm ) , CTX was compared with MQ-IPTp ( N = 140 ) .
METHODS	In both the trials , the primary end point was microscopic placental parasitemia .
RESULTS	At delivery , 1 woman in each CTX-alone treatment group exhibited placental parasitemia , versus no women in the groups receiving MQ .
RESULTS	CTX alone demonstrated noninferiority in the CTX-mandatory trial .
RESULTS	However , polymerase chain reaction-detected placental parasitemia was markedly reduced in the CTX + MQ group compared with CTX alone ( 0/105 vs. 5/103 , P = 0.03 ) .
RESULTS	Because of insufficient recruitment in the CTX-not-mandatory trial , noninferiority could not be conclusively assessed .
RESULTS	Dizziness and vomiting of moderate intensity were reported by 34 % -37 % of women receiving MQ in both the trials , versus 0 % -3 % in CTX groups ( P < 0.0001 ) .
RESULTS	No serious adverse events related to these drugs were found .
CONCLUSIONS	CTX alone provided adequate protection against malaria in HIV-infected pregnant women , although MQ-IPTp showed higher efficacy against placental infection .
CONCLUSIONS	Although more frequently associated with dizziness and vomiting , MQ-IPTp may be an effective alternative given concerns about parasite resistance to CTX .

###25260723
OBJECTIVE	The best method of initial airway management during resuscitation for out of hospital cardiac arrest ( OHCA ) is unknown .
OBJECTIVE	The airway management techniques used currently by UK paramedics during resuscitation for OHCA are not well documented .
OBJECTIVE	This study describes the airway management techniques used in the usual practice arm of the REVIVE-Airways feasibility study , and documents the pathway of interventions to secure and sustain ventilation during OHCA .
METHODS	Data were collected from OHCAs attended by paramedics participating in the REVIVE-Airways trial between March 2012 and February 2013 .
METHODS	Patients were included if they were enrolled in the usual practice arm of the study , fulfilled the main study eligibility criteria and did not receive either of the intervention supraglottic airway devices during the resuscitation attempt .
RESULTS	Data from 196 attempted resuscitations were included in the analysis .
RESULTS	The initial approach to airway management was bag-mask for 108 ( 55 % ) , a supraglottic airway device ( SAD ) for 39 ( 20 % ) and tracheal intubation for 49 ( 25 % ) .
RESULTS	Paramedics made further airway interventions in 64 % of resuscitations .
RESULTS	When intubation was the initial approach , there was no further intervention in 76 % of cases ; this compares to 16 % and 44 % with bag-mask and SAD respectively .
RESULTS	The most common reason cited by paramedics for changing from bag-mask was to carry out advanced life support , followed by regurgitation and inadequate ventilation .
RESULTS	Inadequate ventilation was the commonest reason cited for removing a SAD .
CONCLUSIONS	Paramedics use a range of techniques to manage the airway during OHCA , and as the resuscitation evolves .
CONCLUSIONS	It is therefore desirable to ensure that a range of techniques and equipment , supported by effective training , are available to paramedics who attend OHCA .

###24849104
OBJECTIVE	In the HORIZONS trial , in-hospital treatment with bivalirudin reduced bleeding and mortality in primary percutaneous coronary intervention ( PCI ) compared with heparin and routine glycoprotein IIb/IIIa inhibitors ( GPI ) .
OBJECTIVE	It is unknown whether this advantage of bivalirudin is observed in comparison with heparins only with GPI used as bailout .
RESULTS	In the EUROMAX study , 2198 patients with ST-segment elevation myocardial infarction ( STEMI ) were randomized during transport for primary PCI to bivalirudin or to heparins with optional GPI .
RESULTS	Primary and principal outcome was the composites of death or non-CABG-related major bleeding at 30 days .
RESULTS	This pre-specified analysis compared patients receiving bivalirudin ( n = 1089 ) with those receiving heparins with routine upstream GPI ( n = 649 ) and those receiving heparins only with GPI use restricted to bailout ( n = 460 ) .
RESULTS	The primary outcome death and major bleeding occurred in 5.1 % with bivalirudin , 7.6 % with heparin plus routine GPI ( HR 0.67 and 95 % CI 0.46-0 .97 , P = 0.034 ) , and 9.8 % with heparins plus bailout GPI ( HR 0.52 and 95 % CI 0.35-0 .75 , P = 0.006 ) .
RESULTS	Following adjustment by logistic regression , bivalirudin was still associated with significantly lower rates of the primary outcome ( odds ratio 0.53 , 95 % CI 0.33-0 .87 ) and major bleeding ( odds ratio 0.44 , 95 % CI 0.24-0 .82 ) compared with heparins alone with bailout GPI .
RESULTS	Rates of stent thrombosis were higher with bivalirudin ( 1.6 vs. 0.6 vs. 0.4 % , P = 0.09 and 0.09 ) .
CONCLUSIONS	Bivalirudin , started during transport for primary PCI , reduces major bleeding compared with both patients treated with heparin only plus bailout GPI and patients treated with heparin and routine GPI , but increased stent thrombosis .

###24291273
OBJECTIVE	This study aimed to investigate the impact of ticagrelor on adenosine plasma concentration ( APC ) in acute coronary syndrome ( ACS ) patients .
BACKGROUND	Ticagrelor is a direct-acting P2Y12-adenosine diphosphate receptor blocker .
BACKGROUND	The clinical benefit of ticagrelor compared with clopidogrel in ACS patients suggests that the drug has non-platelet-directed properties .
BACKGROUND	Animal andin vitro models suggested that the `` pleiotropic '' properties of ticagrelor may be related to an interaction with adenosine metabolism .
METHODS	We prospectively randomized 60 ACS patients to receive ticagrelor or clopidogrel .
METHODS	The APC was measured by liquid chromatography .
METHODS	To assess the mechanism of APC variation , we measured adenosine deaminase concentration , adenosine uptake by red blood cells , and cyclic adenosine monophosphate production by cells overexpressing adenosine receptors .
METHODS	The P2Y12-adenosine diphosphate receptor blockade was assessed by the vasodilator-stimulated phosphoprotein index .
RESULTS	Patients receiving ticagrelor had significantly higher APC than patients receiving clopidogrel ( 1.5 M [ interquartile range : 0.98 to 1.7 M ] vs. 0.68 M [ interquartile range : 0.49 to 0.78 M ] ; p < 0.01 ) .
RESULTS	The APC was not correlated with vasodilator-stimulated phosphoprotein ( p = 0.16 ) .
RESULTS	Serum-containing ticagrelor inhibited adenosine uptake by red blood cells compared with clopidogrel or controls ( p < 0.01 for both comparisons ) .
RESULTS	Adenosine deaminase activity was similar in serum of patients receiving clopidogrel or ticagrelor ( p = 0.1 ) .
RESULTS	Ticagrelor and clopidogrel had no direct impact on adenosine receptors ( p = not significant ) .
CONCLUSIONS	Ticagrelor increases APC in ACS patients compared with clopidogrel by inhibiting adenosine uptake by red blood cells .

###24876916
OBJECTIVE	To test the hypothesis that neonatal supplementation with lutein in the first hours of life reduces neonatal oxidative stress ( OS ) in the immediate postpartum period .
METHODS	A randomized controlled , double-blinded clinical trial was conducted among 150 newborns divided into control group , not supplemented ( n = 47 ) , and test group , supplemented with lutein on the first day postpartum ( n = 103 ) .
METHODS	Blood Samples were collected at birth from cord and at 48hrs postpartum while routine neonatal metabolic screenings were taking place .
METHODS	Total hydroperoxide ( TH ) , advanced oxidation protein products ( AOPP ) , and biological antioxidant potential ( BAP ) were measured by spectrophotometry and data were analyzed by Wilcoxon rank sum test and by multivariate logistic regression analysis .
RESULTS	Before lutein supplementation , the mean blood concentrations of AOPP , TH , and BAP were 36.10 umol/L , 156.75 mmol/H2O2 , and 2361.04 umol/L in the test group .
RESULTS	After lutein supplementation , significantly higher BAP increment ( 0.170.22 versus 0.06 versus 0.46 ) and lower TH increment ( 0.460.54 versus 0.340.52 ) were observed in the test group compared to controls .
CONCLUSIONS	Neonatal supplementation with lutein in the first hours of life increases BAP and reduces TH in supplemented babies compared to those untreated .
CONCLUSIONS	The generation of free radical-induced damage at birth is reduced by lutein .
CONCLUSIONS	This trial is registered with ClinicalTrials.gov NCT02068807 .

###25014688
BACKGROUND	The efficacy and toxic effects of nucleoside reverse-transcriptase inhibitors ( NRTIs ) are uncertain when these agents are used with a protease inhibitor in second-line therapy for human immunodeficiency virus ( HIV ) infection in resource-limited settings .
BACKGROUND	Removing the NRTIs or replacing them with raltegravir may provide a benefit .
METHODS	In this open-label trial in sub-Saharan Africa , we randomly assigned 1277 adults and adolescents with HIV infection and first-line treatment failure to receive a ritonavir-boosted protease inhibitor ( lopinavir-ritonavir ) plus clinician-selected NRTIs ( NRTI group , 426 patients ) , a protease inhibitor plus raltegravir in a superiority comparison ( raltegravir group , 433 patients ) , or protease-inhibitor monotherapy after 12 weeks of induction therapy with raltegravir in a noninferiority comparison ( monotherapy group , 418 patients ) .
METHODS	The primary composite end point , good HIV disease control , was defined as survival with no new World Health Organization stage 4 events , a CD4 + count of more than 250 cells per cubic millimeter , and a viral load of less than 10,000 copies per milliliter or 10,000 copies or more with no protease resistance mutations at week 96 and was analyzed with the use of imputation of data ( 4 % ) .
RESULTS	Good HIV disease control was achieved in 60 % of the patients ( mean , 255 patients ) in the NRTI group , 64 % of the patients ( mean , 277 ) in the raltegravir group ( P = 0.21 for the comparison with the NRTI group ; superiority of raltegravir not shown ) , and 55 % of the patients ( mean , 232 ) in the monotherapy group ( noninferiority of monotherapy not shown , based on a 10-percentage-point margin ) .
RESULTS	There was no significant difference in rates of grade 3 or 4 adverse events among the three groups ( P = 0.82 ) .
RESULTS	The viral load was less than 400 copies per milliliter in 86 % of patients in the NRTI group , 86 % in the raltegravir group ( P = 0.97 ) , and 61 % in the monotherapy group ( P < 0.001 ) .
CONCLUSIONS	When given with a protease inhibitor in second-line therapy , NRTIs retained substantial virologic activity without evidence of increased toxicity , and there was no advantage to replacing them with raltegravir .
CONCLUSIONS	Virologic control was inferior with protease-inhibitor monotherapy .
CONCLUSIONS	( Funded by European and Developing Countries Clinical Trials Partnership and others ; EARNEST Current Controlled Trials number , ISRCTN37737787 , and ClinicalTrials.gov number , NCT00988039 . )

###24494280
OBJECTIVE	To assess the clinical efficacy on post-stroke shoulder-hand syndrome ( SHS ) treated with acupuncture and rehabilitation and the impacts on patients ' nailfold microcirculation .
METHODS	One hundred and twenty patients were randomized into an acupuncture rehabilitation group and a simple rehabilitation group , 60 cases in each one .
METHODS	In the simple rehabilitation group , OT ( comprehensive rehabilitation therapy ) training was adopted .
METHODS	In the acupuncture rehabilitation group , on the basis of the treatment as the simple rehabilitation , acu puncture was added at Taiyuan ( LU 9 ) , Zusanli ( ST 36 ) , Xuanzhong ( GB 39 ) , Waiguan ( TE 5 ) , Shousanli ( LI 10 ) , Quchi ( LI 11 ) and Jianyu ( LI 15 ) .
METHODS	Acupuncture was given once a day , 7 days made one session .
METHODS	Totally , 4 sessions of treatment were required .
METHODS	Fugl-Meyer score , upper limb pain score , the score of nerve function defect and the items of nailfold microcirculation of patients were assessed in the the two groups before and after treatment .
METHODS	The efficacy was compared between the two groups .
RESULTS	( 1 ) The upper limb pain , the systematic motor function of the upper limbs , the nerve function defect , nailfold microcirculation and clinical symptoms were all improved after treatment in either the acupuncture rehabilitation group or the simple rehabilitation group as compared with those before treatment , indicating the significant difference ( P < 0.05 , P < 0.01 ) .
RESULTS	( 2 ) The im provements in the upper limb pain ( 0.90 + / -0.71 vs 1.80 + / -0.66 ) , the systematic motor function of the upper limbs ( 42.43 13.57 vs 29.98 + / -15.11 ) , the nerve function defect ( 8.60 + / -11.61 vs 13.0 + / -1.74 ) , nailfold microcirculation ( total score 3.18 + / -1.32 vs 4.34 + / -1.23 ) and clinical symptoms in the acupuncture rehabilitation group after treatment were different significantly as compared with those in the simple rehabilitation group ( PO0.05,P-O .
RESULTS	01 ) , and the results in the acupuncture rehabilitation group were superior to the simple rehabilitation group .
RESULTS	( 3 ) In the acupuncture rehabilitation group , the markedly effective rate was 50.0 % ( 30/60 ) and the total effective rate was 93.3 % ( 56/60 ) , which was better than 16.7 % ( 10/60 ) and 63.3 % ( 38/60 ) respectively in the simple rehabilitation group ( all P < 0.05 ) .
CONCLUSIONS	Both the combined therapy of acupuncture and rehabilitation and the simple rehabilitation training are effective in the treatment of post-stroke SHS , and promote the status of nailfold microcirculation , the efficacy of the combined therapy is better than that of the latter .

###24445955
OBJECTIVE	Preterm infants have immature respiratory control and resulting intermittent hypoxia ( IH ) .
OBJECTIVE	The extent of IH after stopping routine caffeine treatment and the potential for reducing IH with extended caffeine treatment are unknown .
OBJECTIVE	To determine ( 1 ) the frequency of IH in premature infants after discontinuation of routine caffeine treatment and ( 2 ) whether extending caffeine treatment to 40 weeks ' postmenstrual age ( PMA ) reduces IH .
METHODS	A prospective randomized clinical study was conducted at 16 neonatal intensive care units in the United States , with an 18-month enrollment period .
METHODS	Preterm infants ( < 32 weeks ' gestation ) previously treated with caffeine were randomized to extended caffeine treatment or usual care ( controls ) at a PMA of at least 34 weeks but less than 37 weeks .
METHODS	Continuous pulse oximeter recordings were obtained through 40 weeks ' PMA .
METHODS	Oximeter data were analyzed by persons masked to patient group .
METHODS	Continued treatment with caffeine .
METHODS	Number of IH events and seconds with less than 90 % hemoglobin oxygen saturation ( Sao2 ) per hour of recording .
RESULTS	Our analysis included 95 preterm infants .
RESULTS	In control infants , the mean ( SD ) time at less than 90 % Sao2 at 35 and 36 weeks ' PMA was 106.3 ( 89.0 ) and 100.1 ( 114.6 ) s/h , respectively .
RESULTS	The number of IH events decreased significantly from 35 to 39 weeks ' PMA ( P = .01 ) .
RESULTS	Extended caffeine treatment reduced the mean time at less than 90 % Sao2 by 47 % ( 95 % CI , -65 % to -20 % ) to 50.9 ( 48.1 ) s/h at 35 weeks and by 45 % ( 95 % CI , -74 % to -17 % ) to 49.5 ( 52.1 ) s/h at 36 weeks .
CONCLUSIONS	Substantial IH persists after discontinuation of routine caffeine treatment and progressively decreases with increasing PMA .
CONCLUSIONS	Extended caffeine treatment decreases IH in premature infants .
BACKGROUND	clinicaltrials.gov Identifier : NCT01875159 .

###24906584
OBJECTIVE	To compare the effect of myopia control between patients treated with low-concentration atropine eye drops combined with auricular acupoint stimulation and those treated with atropine alone .
METHODS	Single-blinded randomized controlled clinical trial in a regional teaching hospital .
METHODS	The patients received either topical 0.125 % atropine nightly plus auricular acupoint stimulation ( 0.125 A + ACU group ) or topical 0.125 % atropine alone nightly ( 0.125 A group ) .
METHODS	The changes in spherical equivalent ( SE ) , axial length ( AL ) , anterior chamber depth ( ACD ) , and intraocular pressure ( IOP ) per year were compared between the two groups .
RESULTS	Seventy-three of 110 total patients ( 66.4 % ) completed at least 6 months of follow-up .
RESULTS	Patients in the 0.125 A + ACU group had less myopic progression and AL elongation ( -0.41 diopter and 0.24 mm/year ) than those in the 0.125 A group ( -0.66 diopter and 0.32 mm/year ) ( mean follow-up 14.7 months , p < 0.0001 and p = 0.02 , respectively ) .
RESULTS	The ACD increased more in the 0.125 A + ACU group than in the 0.125 A group ( 0.076 mm vs. 0.023 mm/year , p = 0.0004 ) .
RESULTS	IOP decreased more in the 0.125 A + ACU group than in the 0.125 A group ( -1.01 mmHg vs. -0.13 mmHg/year , p = 0.007 ) .
RESULTS	A decrease of 1 mmHg of IOP correlated with a decrease of myopic progression of 0.021 diopter/year ( p = 0.006 ) .
CONCLUSIONS	Patients treated with 0.125 % atropine eye drops plus auricular acupoint stimulation had less myopic progression , less axial length elongation , more anterior chamber deepening , and greater IOP reductions than those treated with 0.125 % atropine alone .
CONCLUSIONS	Auricular acupoint stimulation in combination with low-concentration topical atropine was beneficial for myopia control .

###25726658
OBJECTIVE	To investigate the curative effect of modified Xuefuzhuyutang on chronic subdural hematoma ( CSDH ) after burr holes irrigation and drainage .
METHODS	From January 2010 to April 2013,137 CSDH patients were randomly divided into two groups : 65 cases of control group and 72 cases of medicine group ( modified Xuefuzhuyutang ) .
RESULTS	Compared with the control group , the cases of total absorption of hematoma in medicine group increased significantly ( P < 0.05 ) .
RESULTS	The cases of 50 % -99 % , 30 % -49 % and 0 % -29 % absorption in above two groups had no significant differences ( P > 0.05 ) .
RESULTS	There were no significant side effects were observed in the two groups .
RESULTS	Compared with the control group , the marked effective cases and total effective cases in medicine group were higher ( P < 0.05 ) .
CONCLUSIONS	Modified Xuefuzhuyutang is effective in reducing the postoperative residual volume and recurrent CS-DH .

###26041600
BACKGROUND	Congestion is the most frequent cause for hospitalization in acute decompensated heart failure .
BACKGROUND	Although decongestion is a major goal of acute therapy , it is unclear how the clinical components of congestion ( eg , peripheral edema , orthopnea ) contribute to outcomes after discharge or how well decongestion is maintained .
RESULTS	A post hoc analysis was performed of 496 patients enrolled in the Diuretic Optimization Strategy Evaluation in Acute Decompensated Heart Failure ( DOSE-AHF ) and Cardiorenal Rescue Study in Acute Decompensated Heart Failure ( CARRESS-HF ) trials during hospitalization with acute decompensated heart failure and clinical congestion .
RESULTS	A simple orthodema congestion score was generated based on symptoms of orthopnea ( 2 pillows = 2 points , < 2 pillows = 0 points ) and peripheral edema ( trace = 0 points , moderate = 1 point , severe = 2 points ) at baseline , discharge , and 60-day follow-up .
RESULTS	Orthodema scores were classified as absent ( score of 0 ) , low-grade ( score of 1-2 ) , and high-grade ( score of 3-4 ) , and the association with death , rehospitalization , or unscheduled medical visits through 60 days was assessed .
RESULTS	At baseline , 65 % of patients had high-grade orthodema and 35 % had low-grade orthodema .
RESULTS	At discharge , 52 % patients were free from orthodema at discharge ( score = 0 ) and these patients had lower 60-day rates of death , rehospitalization , or unscheduled visits ( 50 % ) compared with those with low-grade or high-grade orthodema ( 52 % and 68 % , respectively ; P = 0.038 ) .
RESULTS	Of the patients without orthodema at discharge , 27 % relapsed to low-grade orthodema and 38 % to high-grade orthodema at 60-day follow-up .
CONCLUSIONS	Increased severity of congestion by a simple orthodema assessment is associated with increased morbidity and mortality .
CONCLUSIONS	Despite intent to relieve congestion , current therapy often fails to relieve orthodema during hospitalization or to prevent recurrence after discharge .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifiers : NCT00608491 , NCT00577135 .

###25062783
BACKGROUND	Poor adherence contributes to uncontrolled asthma .
BACKGROUND	Pragmatic adherence interventions for primary care settings are lacking .
OBJECTIVE	To test the effectiveness of 2 brief general practitioner ( GP ) - delivered interventions for improving adherence and asthma control .
METHODS	In a 6-month cluster randomized 2 2 factorial controlled trial , with GP as unit of cluster , we compared inhaler reminders and feedback ( IRF ) and/or personalized adherence discussions ( PADs ) with active usual care alone ; all GPs received action plan and inhaler technique training .
METHODS	GPs enrolled patients prescribed combination controller inhalers , with suboptimal Asthma Control Test ( ACT ) scores ( ACT score 19 ) .
METHODS	Inhaler monitors recorded fluticasone propionate/salmeterol adherence ( covertly for non-IRF groups ) and , in IRF groups , provided twice-daily reminders for missed doses , and adherence feedback .
METHODS	PAD GPs received communication training regarding adherence .
METHODS	Outcomes collected every 2 months included ACT scores ( primary outcome ) and severe exacerbations .
METHODS	Intention-to-treat mixed-model analysis incorporated cluster effect and repeated measures .
RESULTS	A total of 43 GPs enrolled 143 patients with moderate-severe asthma ( mean age , 40.3 15.2 years ; ACT score , 14.6 3.8 ; fluticasone propionate dose , 718 470 g ) .
RESULTS	Over 6 months , adherence was significantly higher in the IRF group than in non-IRF groups ( 73 % 26 % vs 46 % 28 % of prescribed daily doses ; P < .0001 ) , but not between PAD and non-PAD groups .
RESULTS	Asthma control improved overall ( mean change in ACT score , 4.5 4.9 ; P < .0001 ) , with no significant difference among groups ( P = .14 ) .
RESULTS	Severe exacerbations were experienced by 11 % of the patients in IRF groups and 28 % of the patients in non-IRF groups ( P = .013 ; after adjustment for exacerbation history ; P = .06 ) .
CONCLUSIONS	Inhaler reminders offer an effective strategy for improving adherence in primary care compared with a behavioral intervention or usual care , although this may not be reflected in differences in day-to-day asthma control .

###26077436
BACKGROUND	Topical formulations of nonsteroidal anti-inflammatory drugs ( NSAIDs ) are generally considered to be safer alternatives to oral NSAIDs due to lower systemic absorption .
BACKGROUND	We conducted randomized , crossover studies that compared the pharmacokinetics ( PK ) , bioequivalence and safety of topical diclofenac sodium 2 % twice daily ( BID ) , diclofenac sodium 1.5 % four times daily ( QID ) and oral diclofenac sodium in healthy subjects .
METHODS	The results of three bioequivalence studies are reviewed .
METHODS	Healthy adult subjects ( n = 76 ) applied topical diclofenac sodium 2 % solution ( 40.4 mg/2 mL ) BID ; or 1.5 % solution ( 19.3 mg/40 drops ) QID to each knee for 7.5 consecutive days separated by a washout period .
METHODS	Subjects ( n = 22 ) in one study also received oral diclofenac sodium 75 mg BID for 7.5 days .
METHODS	Plasma diclofenac concentrations were determined from serial blood samples collected on Days 1 and 8 ( steady state ) , and diclofenac PK parameters were estimated by noncompartmental methods .
RESULTS	The studies demonstrated comparable bioequivalence between the 2 % and 1.5 % topical solutions as well as lower systemic exposure compared to oral dosing ( approximately 93 % less ) .
RESULTS	Daily systemic exposure was comparable between the two formulations with only a 12 % difference in the AUCss ( 0-24 ) ( p = 0.140 ) .
RESULTS	Furthermore , both topical solutions demonstrated delayed elimination with a t ( 1/2 ) of 4 - to 6-fold longer , as compared to oral diclofenac .
RESULTS	The 2 % solution provided more consistent dosing relative to the 1.5 % solution when comparing AUCss ( 0-24 ) and Cmaxss across studies .
RESULTS	Mild application site reactions were the most common treatment-emergent adverse event reported with topical diclofenac .
CONCLUSIONS	The steady-state PK profile of topical diclofenac 2 % solution administered BID is similar to that of the 1.5 % solution administered QID .
CONCLUSIONS	Systemic exposure to diclofenac is substantially lower after topical application as compared to oral administration .
CONCLUSIONS	( Study 2 was registered with ClinicalTrials.gov ; NCT01202799 ; https://clinicaltrials.gov/ct2/results?term=01202799&Search=Search ) .

###24860256
BACKGROUND	Tracheal intubation without muscle relaxants is usually performed with remifentanil and propofol or sevoflurane .
BACKGROUND	Remifentanil 1.0 to 4.0 gkg ( -1 ) and propofol 2.0-3 .0 mgkg ( -1 ) or sevoflurane up to 8.0 Vol % provide acceptable , i.e. excellent or good intubating conditions .
BACKGROUND	We hypothesized that sevoflurane 1.0 MAC would provide acceptable intubating conditions when combined with propofol and remifentanil .
METHODS	Eighty-three patients to be intubated were randomised to two groups .
METHODS	The SEVO group received propofol 1.5 mgkg ( -1 ) , remifentanil 0.30 gkgmin ( -1 ) and sevoflurane 1.0 MAC ; the MR group received the same doses of propofol and remifentanil plus rocuronium 0.45 mgkg ( -1 ) .
METHODS	We evaluated intubation and extubation conditions , mean arterial pressure ( MAP ) , heart rate ( HR ) and bispectral index ( BIS ) .
METHODS	The vocal cords were examined for injury by videolaryngoscopy before and 24hours after surgery .
RESULTS	ACCEPTABLE INTUBATING CONDITIONS WERE SEEN MORE FREQUENTLY WITH ROCURONIUM THAN WITH SEVOFLURANE : 97 % versus 82 % ; p = 0.03 ; the subscore for vocal cords was comparable : 100 % versus 98 % .
RESULTS	MAP before intubation decreased significantly compared with the MAP at baseline to the same extent in both groups ; ephedrine IV was given in 15 ( SEVO ) versus 16 ( MR ) patients ; p = 0.93 .
RESULTS	BIS at tracheal intubation was 27 ( 13-65 ) in the SEVO group , 29 ( 14-62 ) in the MR group ; p = 0.07 .
RESULTS	Vocal cord injuries ( oedema , haematoma ) were similar : 4 patients in each group .
CONCLUSIONS	Overall intubating conditions were better when rocuronium was used ; the subscore for vocal cords was comparable .
CONCLUSIONS	The incidence of side effects was the same in the two groups .
BACKGROUND	ClinicalTrials.Gov : NCT 01591031 .

###24639273
OBJECTIVE	To examine parental reports of feeding and activity behaviors in a cohort of parents of 2-month-olds and how they differ by race/ethnicity .
METHODS	Parents participating in Greenlight , a cluster , randomized trial of obesity prevention at 4 health centers , were queried at enrollment about feeding and activity behaviors thought to increase obesity risk .
METHODS	Unadjusted associations between race/ethnicity and the outcomes of interest were performed by using Pearson ( 2 ) and Kruskal-Wallis tests .
METHODS	Adjusted analyses were performed by using proportional odds logistic regressions .
RESULTS	Eight hundred sixty-three parents ( 50 % Hispanic , 27 % black , 18 % white ; 86 % Medicaid ) were enrolled .
RESULTS	Exclusive formula feeding was more than twice as common ( 45 % ) as exclusive breastfeeding ( 19 % ) ; 12 % had already introduced solid food ; 43 % put infants to bed with bottles ; 23 % propped bottles ; 20 % always fed when the infant cried ; 38 % always tried to get children to finish milk ; 90 % were exposed to television ( mean , 346 minutes/day ) ; 50 % reported active television watching ( mean , 25 minutes/day ) ; and 66 % did not meet `` tummy time '' recommendations .
RESULTS	Compared with white parents , black parents were more likely to put children to bed with a bottle ( adjusted odds ratio [ aOR ] = 1.97 , P < .004 ; bottle propping , aOR = 3.1 , P < .001 ) , and report more television watching ( aOR = 1.6 , P = .034 ) .
RESULTS	Hispanic parents were more likely than white parents to encourage children to finish feeding ( aOR = 1.9 , P = .007 ) , bottle propping ( aOR = 2.5 , P = .009 ) , and report less tummy time ( aOR = 0.6 , P = .037 ) .
CONCLUSIONS	Behaviors thought to relate to later obesity were highly prevalent in this large , diverse sample and varied by race/ethnicity , suggesting the importance of early and culturally-adapted interventions .

###25271034
BACKGROUND	Chronic liver disease and cirrhosis are collectively ranked as the ninth most prevalent cause of death in Taiwan .
BACKGROUND	Ascites is the most common comorbidity associated with liver cirrhosis .
BACKGROUND	Different body postures affect pulmonary ventilation and arterial oxygen partial pressure .
BACKGROUND	Thus , ensuring proper body posture in patients is an important clinical nursing intervention that significantly affects the recovery of patients .
OBJECTIVE	This study investigates the effects of head posture on oxygenation saturation , comfort , and dyspnea in patients with liver cirrhosis-related ascites .
METHODS	A quasi-experimental study design was used .
METHODS	A total of 252 participants were recruited from a medical centre hospital in Taiwan .
METHODS	Participants were allocated randomly into three groups of bed-elevation angles : 15 degrees , 30 degrees , and 45 degrees .
METHODS	The physiological indices were measured at 5 , 10 , 15 , 20 , 25 , and 30 minutes in order to investigate the change in oxygenation saturations that were attributable to the different angles .
METHODS	Data were analyzed using descriptive statistics .
METHODS	The generalized estimating equation ( GEE ) was used for statistical analysis , with the level of significance set at : = .05 .
RESULTS	After controlling for confounding variables , the results showed that patients in the three groups earned similar scores for the degree of difficulty in the oxygen values .
RESULTS	The supine group earned significantly different scores than the other two groups in terms of blood oxygen values related to time to change the angle of the three groups at five minutes after adjusting the angle ( p < .01 ) .
RESULTS	This study found no differences among the three groups in terms of comfort .
RESULTS	In terms of breathing , this study found a significant difference between 45-degree and 15-degree supine dyspnea ( p < .05 ) .
RESULTS	Therefore , patients with ascites at 15 degrees supine and with better access to better oxygen saturation had superior results to their peers at 30 degrees and 45 degrees supine .
RESULTS	Furthermore , this group was less likely to perceive breathing difficulties .
CONCLUSIONS	The results of this study may guide health education and care for nurses in order to improve the quality of care for patients with chronic liver disease / cirrhosis with concomitant ascites .

###24927607
OBJECTIVE	Filibuvir is a non-nucleoside inhibitor of hepatitis C virus ( HCV ) polymerase .
OBJECTIVE	This study evaluated the safety and efficacy of filibuvir plus pegylated interferon alfa-2a ( pegIFN ) / ribavirin .
METHODS	Treatment-nave , HCV genotype-1 patients were randomized to receive filibuvir 300 or 600 mg twice daily ( BID ) or placebo plus pegIFN ( 180 g/wk ) and ribavirin ( 1,000 / 1,200 mg BID ) for 24 weeks .
METHODS	Filibuvir patients who achieved defined response through week 24 discontinued therapy at week 24 .
METHODS	All other patients continued on open-label pegIFN/ribavirin through week 48 .
METHODS	The primary endpoint was the proportion of patients who achieved sustained virologic response ( SVR ) defined as HCV RNA < 15 IU/mL at end of treatment ( weeks 24 or 48 ) and week 72 .
RESULTS	Overall , 288 patients were randomized and treated .
RESULTS	SVR was achieved by 41.7 , 39.6 , and 45.8 % of patients in the filibuvir 300 mg , 600 mg , and placebo arms , respectively .
RESULTS	While the addition of filibuvir to pegIFN/ribavirin improved on-treatment virologic response parameters , this did not translate into improved SVR rates due to a high rate of virologic relapse following completion of therapy ( 300 mg : 35.9 % ; 600 mg : 42.9 % ; placebo : 25.4 % ) .
RESULTS	The most commonly reported adverse events were nausea , fatigue , headache , and insomnia , and were reported at similar rates across arms .
CONCLUSIONS	Filibuvir plus pegIFN/ribavirin did not improve the percentage of patients achieving SVR compared with administration of pegIFN/ribavirin alone .
CONCLUSIONS	However , the agent was well tolerated and was associated with higher on-treatment virologic response parameters .
CONCLUSIONS	Further evaluation of filibuvir in combination with other direct-acting antiviral agents may be considered .

###24720918
OBJECTIVE	The purpose of this study was to evaluate the efficacy and safety of the selective endothelin type A ( ETA ) receptor antagonist sitaxsentan in patients who have heart failure with preserved ejection fraction ( HFpEF ) .
BACKGROUND	Fifty percent of heart failure ( HF ) patients have a preserved ejection fraction .
BACKGROUND	No treatment has been shown to improve their clinical outcomes .
BACKGROUND	Previous studies have suggested that ETA receptor antagonists might improve diastolic function and exercise tolerance in some forms of HF .
METHODS	In all , 192 HFpEF patients ( EF50 % ) were randomly assigned 2:1 to sitaxsentan 100 mg/day ( n = 128 ) versus placebo ( n = 64 ) for 24 weeks .
METHODS	The primary endpoint was change in treadmill exercise time after 24 weeks of treatment .
METHODS	Secondary objectives included changes in left ventricular mass , transmitral inflow velocity to early diastolic mitral annulus velocity ratio , and Minnesota Living With Heart Failure questionnaire , and New York Heart Association functional class .
METHODS	Subjects were age 65 11 years , 63 % female , 29 % non-Caucasian , and in functional class II ( 56.5 % ) or III ( 43.5 % ) .
RESULTS	Subjects treated with sitaxsentan had an increase in median treadmill time ( 90 s ) compared with placebo-treated subjects ( 37 s , p = 0.0302 ) .
RESULTS	There was no significant treatment differences in transmitral inflow velocity to early diastolic mitral annulus velocity ratio , left ventricular mass , Minnesota Living With Heart Failure questionnaire , NewYork Heart Association functional class , deaths , or HF hospital stay .
RESULTS	The incidence of adverse events was similar for sitaxsentan and placebo .
CONCLUSIONS	In HFpEF patients , treatment with a selective ETA receptor antagonist increased exercise tolerance but did not improve any of the secondary endpoints such as left ventricular mass or diastolic function .
CONCLUSIONS	Further studies will benecessary to determine whether ETA receptor antagonists may be useful in the treatment of HFpEF .
CONCLUSIONS	( A Study ofthe Effectiveness of Sitaxsentan Sodium in Patients With Diastolic Heart Failure ; NCT00303498 ) .

###25343850
OBJECTIVE	Large preloads of protein and fat have been shown to lower glucose after a carbohydrate-rich meal in people with type 2 diabetes but add a considerable energy burden .
OBJECTIVE	Low calorie preloads [ < 5 % of daily energy intake ] have been tested in this study in people with prediabetes and with type 2 diabetes .
METHODS	This was an unblinded randomised crossover study with two placebo days and two active treatment days .
METHODS	Glucose was measured for 3hours with fingerprick samples as well as continuous glucose monitoring [ CGMS ] .
METHODS	Twenty-four subjects with pre-diabetes or moderately controlled type 2 diabetes [ fasting glucose < 10 and HbA1c < 8.5 % ] were recruited .
METHODS	The preload contained 17g whey protein plus 3g lactose and 5g guar , and 1g flavour material [ including sucralose ] dissolved in 150ml cold water or 150ml cold water with no additives .
METHODS	The breakfast test meal consisted of 2 slices of bread , margarine and jam [ 3 slices for men ] with the test drink 15minutes beforehand .
RESULTS	Peak fingerprick glucose was reduced by 2.1 mmol/L at 45min [ p < 0.0001 ] .
RESULTS	Average fingerprick glucose over 3hours was reduced by 0.8 mmol/L [ p = 0.0003 ] .
RESULTS	There was no difference between those with diabetes or prediabetes or those on medication or not on medication .
CONCLUSIONS	An 80kcal whey protein/fibre preload can lower average glucose over 3hours by 0.8 mmol/L .
CONCLUSIONS	If used long term before at least two carbohydrate-rich meals/day this preload could lower HbA1c by up to 1 % .
BACKGROUND	The trial was registered with the Australian New Zealand Clinical Trials Registry number ACTRN12612001251819 .

###24325663
OBJECTIVE	To evaluate the outcomes of transcrestal sinus floor elevation ( tSFE ) performed with a minimally invasive procedure ( Smart Lift technique ) combined with the additional use of deproteinized bovine bone mineral ( DBBM ) or - tricalcium phosphate ( - TCP ) .
METHODS	In a multicenter randomized controlled trial , 38 sites in 38 patients were treated with the Smart Lift technique in association with DBBM ( n = 19 ) or - TCP ( n = 19 ) .
METHODS	The extent of the sinus lift ( SL ) and the height of the graft apical to the implant apex ( aGH ) were assessed on periapical radiographs taken immediately after surgery and at 6 months following surgery .
RESULTS	( i ) Substantial aGH and SL were observed immediately after surgery and at 6 months , with no significant differences between DBBM and - TCP groups ; ( ii ) a significant graft remodelling was observed from post-surgery to 6-months in the - TCP group and ( iii ) limited incidence of complications as well as limited post-operative pain and discomfort were associated with the use of both graft materials .
CONCLUSIONS	The Smart Lift technique in conjunction with the additional use of either DBBM or - TCP may provide a substantial elevation of the maxillary sinus floor along with limited post-surgical complications and post-operative pain/discomfort .

###24947719
OBJECTIVE	This study sought to evaluate the efficacy of prasugrel versus clopidogrel in ST-segment elevation myocardial infarction ( STEMI ) by the timing of percutaneous coronary intervention ( PCI ) .
BACKGROUND	Treatment strategies and outcomes for patients with STEMI may differ when treated with primary compared with secondary PCI .
METHODS	STEMI patients in the TRITON-TIMI 38 ( Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel-Thrombolysis In Myocardial Infarction 38 ) were randomized to prasugrel or clopidogrel on presentation if primary PCI was intended or later during secondary PCI .
METHODS	Primary PCI was defined as within 12 h of symptom onset .
METHODS	The primary endpoint was cardiovascular death , myocardial infarction ( MI ) , or stroke .
METHODS	Because periprocedural MI is difficult to assess in the setting of STEMI , we performed analyses excluding these events .
RESULTS	Reductions in the primary endpoint with prasugrel versus clopidogrel ( hazard ratio [ HR ] : 0.79 ; 95 % confidence interval [ CI ] : 0.65 to 0.97 ; p = 0.022 ) were consistent between primary and secondary PCI patients at 15 months ( HR : 0.89 ; 95 % CI : 0.69 to 1.13 vs. HR : 0.65 ; 95 % CI : 0.46 to 0.93 ; p interaction = 0.15 ) .
RESULTS	However , a tendency toward a difference in treatment effect at 30 days ( HR : 0.68 ; 95 % CI : 0.54 to 0.87 ; p = 0.002 ) was observed between primary and secondary PCI patients ( HR : 0.81 ; 95 % CI : 0.60 to 1.09 vs. HR : 0.51 ; 95 % CI : 0.34 to 0.76 ; p interaction = 0.06 ) .
RESULTS	When periprocedural MI was excluded , the efficacy of prasugrel remained consistent among primary and secondary PCI patients at 30 days ( HR : 0.53 ; 95 % CI : 0.34 to 0.81 vs. HR : 0.44 ; 95 % CI : 0.22 to 0.88 ; p interaction = 0.68 ) and 15 months ( HR : 0.76 ; 95 % CI : 0.56 to 1.03 vs. HR : 0.75 ; 95 % CI : 0.46 to 1.21 ; p interaction = 0.96 ) .
CONCLUSIONS	The efficacy of prasugrel versus clopidogrel was consistent irrespective of the timing of PCI , particularly in preventing nonprocedural events .
CONCLUSIONS	( Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel-Thrombolysis in Myocardial Infarction 38 ; NCT00097591 ) .

###24238686
OBJECTIVE	Validated questionnaires can improve the identification of psychosocial problems in community pediatric services .
OBJECTIVE	Our aim was to assess which of 3 short questionnaires-the Brief Infant-Toddler Social and Emotional Assessment ( BITSEA ) , the Ages and Stages Questionnaires : Social-Emotional ( ASQ : SE ) , and the KIPPPI ( Brief Instrument Psychological and Pedagogical Problem Inventory ) - was most suitable as a routine screening tool for identification among toddlers .
METHODS	We included 2106 parents ( response rate 81 % ) of children aged 6 , 14 , or 24 months at routine well-child visits in 18 services across the Netherlands .
METHODS	Child health care professionals interviewed and examined children and parents .
METHODS	Parents were randomized to complete either the BITSEA or the KIPPPI ; all filled out the ASQ : SE and the Child Behavior Checklist .
METHODS	For each questionnaire , we assessed the internal consistency , validity with Child Behavior Checklist-Total Problems Score ( CBCL-TPS ) as a criterion , and added value to identification compared to clinical assessment alone .
RESULTS	Cronbach 's alphas of the total scales varied between 0.46 to 0.91 .
RESULTS	At the ages of 6 and 14 months , none of the instruments studied had adequate validity .
RESULTS	At the age of 24 months , only the BITSEA discriminated sufficiently between children with and without problems ( sensitivity = 0.84 at specificity = 0.90 ) , but not the other 2 questionnaires ( with sensitivity indices varying between 0.53 and 0.60 at similar specificity ) .
RESULTS	The BITSEA at this age offered slightly higher added value to the identification of psychosocial problems by child health care professionals .
CONCLUSIONS	For toddlers aged 6 and 14 months , no questionnaire is sufficiently valid to support the identification of psychosocial problems .
CONCLUSIONS	The BITSEA is the best short tool for the early detection of psychosocial problems in 2-year-old children .

###24976429
OBJECTIVE	The cholesterol-lowering effects of garlic as part of a healthy diet remain controversial .
OBJECTIVE	The aim of this study was to investigate whether supplementation with aged black garlic ( ABG ) could improve blood lipid profiles in patients with mild hypercholesterolemia .
METHODS	We conducted a double-blind , randomized placebo-controlled trial .
METHODS	Sixty participants were randomly assigned to receive either ABG or placebo twice daily ( total 6 g/d ) before consumption of a meal every morning and evening for 12 wk .
METHODS	During the study , two participants dropped out of the ABG group , and three participants dropped out of the placebo group .
METHODS	Thus , the effects of AGB on fasting blood levels of lipids were evaluated in 28 participants and compared with the placebo group ( n = 27 ) .
RESULTS	Among lipid components , no significant differences in triglycerides , low-density lipoprotein cholesterol , total cholesterol , or free fatty acid levels were observed between the two groups .
RESULTS	However , ABG increased high-density lipoprotein cholesterol levels compared with the placebo group at the end of the study .
RESULTS	Moreover , a significant decrease in the levels of alipoprotein B and a significant increase in the ratio of low-density lipoprotein cholesterol/alipoprotein B were observed in the ABG group .
RESULTS	No adverse effects were reported in any of the patients .
CONCLUSIONS	ABG supplementation reduced atherogenic markers and thus may have a cardioprotective effect beyond the gold standard medication in patients with mild hypercholesterolemia .

###25079861
OBJECTIVE	We evaluated the effects of colestilan , a non-absorbed anion-exchange resin , on lipids and lipoproteins in dialysis patients .
METHODS	This randomized , double-blind , double-dummy , flexible-dose study incorporating a placebo-controlled withdrawal period tested for superiority vs. placebo and non-inferiority vs. simvastatin .
METHODS	Dialysis patients with serum low-density lipoprotein ( LDL-C ) 100 mg/dL received colestilan 3 - 12 g/day or simvastatin 10 - 40 mg/day for 16 weeks , and were then re-randomized to continue active medication or receive placebo for 4 weeks .
METHODS	Co-primary endpoints were the percent change in serum LDL-C level during the active and placebo comparison phases .
RESULTS	Colestilan was non-inferior to simvastatin for lowering serum LDL-C ( mean changes -29.5 % vs. -28.9 % ; difference 0.6 % , 95 % CI -5.7 , 4.5 ) .
RESULTS	Colestilan was more effective than placebo at maintaining control of serum LDL-C levels during the withdrawal phase ( mean change +4.4 % vs. +41.7 % ; difference -37.4 % ; p < 0.001 ) .
RESULTS	Reductions in total cholesterol were similar with both drugs , but simvastatin was more effective at controlling triglyceride levels .
RESULTS	Adverse events most commonly affected the gastrointestinal system .
CONCLUSIONS	In dialysis patients , colestilan was more effective than placebo at maintaining control of serum LDL-C levels , was noninferior to simvastatin in terms of the reduction in LDL-C achieved , and was generally well tolerated .

###24898233
BACKGROUND	Popular beliefs that breakfast is the most important meal of the day are grounded in cross-sectional observations that link breakfast to health , the causal nature of which remains to be explored under real-life conditions .
OBJECTIVE	The aim was to conduct a randomized controlled trial examining causal links between breakfast habits and all components of energy balance in free-living humans .
METHODS	The Bath Breakfast Project is a randomized controlled trial with repeated-measures at baseline and follow-up in a cohort in southwest England aged 21-60 y with dual-energy X-ray absorptiometry-derived fat mass indexes 11 kg/m in women ( n = 21 ) and 7.5 kg/m in men ( n = 12 ) .
METHODS	Components of energy balance ( resting metabolic rate , physical activity thermogenesis , energy intake ) and 24-h glycemic responses were measured under free-living conditions with random allocation to daily breakfast ( 700 kcal before 1100 ) or extended fasting ( 0 kcal until 1200 ) for 6 wk , with baseline and follow-up measures of health markers ( eg , hematology/biopsies ) .
RESULTS	Contrary to popular belief , there was no metabolic adaptation to breakfast ( eg , resting metabolic rate stable within 11 kcal/d ) , with limited subsequent suppression of appetite ( energy intake remained 539 kcal/d greater than after fasting ; 95 % CI : 157 , 920 kcal/d ) .
RESULTS	Rather , physical activity thermogenesis was markedly higher with breakfast than with fasting ( 442 kcal/d ; 95 % CI : 34 , 851 kcal/d ) .
RESULTS	Body mass and adiposity did not differ between treatments at baseline or follow-up and neither did adipose tissue glucose uptake or systemic indexes of cardiovascular health .
RESULTS	Continuously measured glycemia was more variable during the afternoon and evening with fasting than with breakfast by the final week of the intervention ( CV : 3.9 % ; 95 % CI : 0.1 % , 7.8 % ) .
CONCLUSIONS	Daily breakfast is causally linked to higher physical activity thermogenesis in lean adults , with greater overall dietary energy intake but no change in resting metabolism .
CONCLUSIONS	Cardiovascular health indexes were unaffected by either of the treatments , but breakfast maintained more stable afternoon and evening glycemia than did fasting .

###24901956
BACKGROUND	Depression is common in people with coronary heart disease ( CHD ) and associated with worse outcome .
BACKGROUND	This study explored the acceptability and feasibility of procedures for a trial and for an intervention , including its potential costs , to inform a definitive randomized controlled trial ( RCT ) of a nurse-led personalised care intervention for primary care CHD patients with current chest pain and probable depression .
METHODS	Multi-centre , outcome assessor-blinded , randomized parallel group study .
METHODS	CHD patients reporting chest pain and scoring 8 or more on the HADS were randomized to personalized care ( PC ) or treatment as usual ( TAU ) for 6 months and followed for 1 year .
METHODS	Primary outcome was acceptability and feasibility of procedures ; secondary outcomes included mood , chest pain , functional status , well being and psychological process variables .
RESULTS	1001 people from 17 General Practice CHD registers in South London consented to be contacted ; out of 126 who were potentially eligible , 81 ( 35 % female , mean age = 65 SD11 years ) were randomized .
RESULTS	PC participants ( n = 41 ) identified wide ranging problems to work on with nurse-case managers .
RESULTS	Good acceptability and feasibility was indicated by low attrition ( 9 % ) , high engagement and minimal nurse time used ( mean/SD = 78/19 mins assessment , 125/91 mins telephone follow up ) .
RESULTS	Both groups improved on all outcomes .
RESULTS	The largest between group difference was in the proportion no longer reporting chest pain ( PC 37 % vs TAU 18 % ; mixed effects model OR 2.21 95 % CI 0.69 , 7.03 ) .
RESULTS	Some evidence was seen that self efficacy ( mean scale increase of 2.5 vs 0.9 ) and illness perceptions ( mean scale increase of 7.8 vs 2.5 ) had improved in PC vs TAU participants at 1 year .
RESULTS	PC appeared to be more cost effective up to a QALY threshold of approximately 3,000 .
CONCLUSIONS	Trial and intervention procedures appeared to be feasible and acceptable .
CONCLUSIONS	PC allowed patients to work on unaddressed problems and appears cheaper than TAU .
BACKGROUND	Controlled-Trials .
BACKGROUND	com ISRCTN21615909 .

###25007667
OBJECTIVE	To investigate the postoperative application of nasopharyngeal airway ( NPA ) in rhinogenous obstructive sleep apnea hypopnea syndrome ( OSAHS ) patients , so that to observe the parameters including vital signs of the patients and evaluatethe value of clinical application and reliability of NPA .
METHODS	A total of 216 patients diagnosed as rhinogenous OSAHS were randomly assigned to experimental group ( setting NPA , 112 cases ) and control group ( not setting NPA , 104 cases ) according to whether NPA was placed in the nasal cavity postoperatively .
METHODS	ECG , oxygen saturation and hemodynamics were monitored for 24 h postoperatively .
METHODS	The pharyngeal pain and discomfort , low oxygen saturation and hemodynamics were compared between these two groups .
METHODS	The subjective assessment and clinical symptoms were compared between the two groups using visual analogue scale ( VAS ) .
RESULTS	The experimental group showed better relief of nasal obstruction , nasal pain , headache , dry pharynx , insomnia and pain while taking out nasal packing compared with control group , where the differences were statistically significant ( P < 0.01 ) .
RESULTS	In the experimental group , the level of LSa2O2 ( P < 0.05 ) , HR ( P < 0.01 ) , SBP ( P < 0.05 ) , DBP ( P < 0.01 ) , MAP ( P < 0.01 ) and RPP ( P < 0.01 ) was significantly lower than in the control group .
CONCLUSIONS	The postoperative application of nasopharyngeal airway in rhinogenous OSAHS patients could help to keep nasal patency and avoid the upper airway obstruction , which exhibited good safety and compliance .
CONCLUSIONS	The nasopharyngeal airway can reduce patients ' discomfort and improve hyoxemia , ensuring hemodynamic stability .

###24447434
BACKGROUND	Activation of the phosphatidylinositol-3-kinase ( PI3K ) and/or mitogen-activated protein kinase ( MAPK ) pathways results in anti-estrogen resistance in vitro , but a biomarker with clinical validity to predict intrinsic resistance has not been identified .
BACKGROUND	In metastatic breast cancer patients with previous exposure to endocrine therapy , the addition of a mammalian target of rapamycine ( mTOR ) inhibitor has been shown to be beneficial .
BACKGROUND	Whether or not patients on adjuvant endocrine treatment might benefit from these drugs is currently unclear .
BACKGROUND	A biomarker that predicts intrinsic resistance could potentially be used as companion diagnostic in this setting .
BACKGROUND	We tested the clinical validity of different downstream-activated proteins in the PI3K and/or MAPK pathways to predict intrinsic tamoxifen resistance in postmenopausal primary breast cancer patients .
METHODS	We recollected primary tumor tissue from patients who participated in a randomized trial of adjuvant tamoxifen ( 1-3 years ) versus observation .
METHODS	After constructing a tissue micro-array , cores from 563 estrogen receptor positive were immunostained for p-AKT ( Thr308 ) , p-AKT ( Ser473 ) , p-mTOR , p-p706SK and p-ERK1 / 2 .
METHODS	Cox proportional hazard models for recurrence free interval were used to assess hazard ratios and interactions between these markers and tamoxifen treatment efficacy .
RESULTS	Interactions were identified between tamoxifen and p-AKT ( Thr308 ) , p-mTOR , p-p70S6K and p-ERK1 / 2 .
RESULTS	Applying a conservative level of significance , p-p70S6K remained significantly associated with tamoxifen resistance .
RESULTS	Patients with p-p70S6K negative tumors derived significant benefit from tamoxifen ( HR 0.24 , P < 0.0001 ) , while patients whose tumor did express p-p70S6K did not ( HR = 1.02 , P = 0.95 ) , P for interaction 0.004 .
RESULTS	In systemically untreated breast cancer patients , p-p70S6K was associated with a decreased risk for recurrence .
CONCLUSIONS	Patients whose tumor expresses p-p70S6K , as a marker of downstream PI3K and/or MAPK pathway activation , have a favorable prognosis , but do not benefit from adjuvant tamoxifen .
CONCLUSIONS	A potential benefit from inhibitors of the PI3K/Akt/mTOR pathway in these patients needs to be further explored .

###25399543
BACKGROUND	The objective of this article is to present the rationale and baseline results for a randomized controlled pilot trial using economic incentives to reduce HIV and sexually transmitted infection ( STI ) risk among male sex workers ( MSWs ) in Mexico City .
METHODS	Participants ( n = 267 ) were tested and treated for STIs ( chlamydia , gonorrhoea , syphilis and HIV ) and viral hepatitis ( hepatitis B and C ) , received HIV and STI prevention education and were randomized into four groups : ( 1 ) control , ( 2 ) medium conditional incentive ( $ 50/six months ) , ( 3 ) high conditional incentive ( $ 75/six months ) and ( 4 ) unconditional incentive ( $ 50/six months ) .
METHODS	In the conditional arms , incentives were contingent upon testing free of new curable STIs ( chlamydia , gonorrhoea and syphilis ) at follow-up assessments .
RESULTS	Participants ' mean age was 25 years ; 8 % were homeless or lived in a shelter , 16 % were unemployed and 21 % lived in Mexico City less than 5 years .
RESULTS	At baseline , 38 % were living with HIV , and 32 % tested positive for viral hepatitis or at least one STI ( other than HIV ) .
RESULTS	Participants had a mean of five male clients in the previous week ; 18 % reported condomless sex with their last client .
RESULTS	For 37 % , sex work was their main occupation and was conducted mainly on the streets ( 51 % ) or in bars/discotheques ( 24 % ) and hotels ( 24 % ) .
RESULTS	The average price for a sex transaction was $ 25 with a 35 % higher payment for condomless sex .
CONCLUSIONS	The findings suggest that economic incentives are a relevant approach for HIV prevention among MSWs , given the market-based inducements for unprotected sex .
CONCLUSIONS	This type of targeted intervention seems to be justified and should continue to be explored in the context of combination prevention efforts .

###25352732
OBJECTIVE	The benefits of antioxidant micronutrients in slowing progression to advanced stages of age-related macular degeneration ( AMD ) was supported by the 4/day tablet form investigated in the Age-related Eye Disease Study 1 ( AREDS1 ) and the 2/day softgel form in the Age-related Eye Disease Study 2 ( AREDS2 ) .
OBJECTIVE	However , the choices of excipient , dosage form , and ingredient chemistry as well as the patient physiologies and pathologies can influence bioavailability and efficacy .
OBJECTIVE	The objective of the study was to explore the influence of dosage form on the bioavailability of the five primary AREDS1 and Tier-2 AREDS2 micronutrients : the metals zinc and copper , - carotene , and vitamins E and C.
OBJECTIVE	The intent was to establish by chemical analysis the relative bioavailabilities of these five micronutrients in plasma , or serum for the metals , as well as to identify any opportunities for improvements .
METHODS	A total of 15 healthy men ( 5 ) and women ( 10 ) were recruited for a controlled , randomized , three-arm , crossover trial of the AREDS1 micronutrients .
METHODS	The study investigated responses in bioabsorption to a single dose of either four tablets or two softgels at the full dose level , or one softgel at the half-dose level .
METHODS	The bioavailability of each micronutrient was based on the pharmacokinetic profiles established through 15 samplings for each ingredient/dosage form in plasma/serum over the course of one week .
RESULTS	Bioavailability was estimated using model-independent and model-dependent procedures .
RESULTS	A statistical advantage of the dosage form was observed in only two cases from the exaggerated effects using the half-dose softgel and for the tablet dosage form for - carotene and vitamin E.
RESULTS	An unanticipated complexity was suggested by the bimodal absorption of zinc .
RESULTS	For these micronutrients , no disadvantage ( though potential advantage ) was inferred for the water-soluble components presented in a softgel formulation .
RESULTS	Increased fractional absorption was observed for the smaller dose ( one capsule versus two ) , but it was not sufficient to reach the level achieved by the full dose of either four tablets or two softgels .
RESULTS	A model-dependent analysis permitted an estimation of the percentage of micronutrients absorbed , with zinc , the single most important ingredient , absorbed at about a 10 % level .
CONCLUSIONS	The results suggest modestly contradictory requirements in the dosage form for water-soluble and lipid-soluble ingredients , as based on a goal of improved bioavailability .
CONCLUSIONS	Comparative consistency in bioavailability was observed across dosage forms , and most nutrients between AREDS1 and AREDS2 ( full dose ) formulations relative to the significant variations observed within this controlled population .
CONCLUSIONS	The results emphasize the importance of defining the requisite bioavailability of each micronutrient and the influence of the dosage form that provides it .
CONCLUSIONS	With the recognition of global and population-specific micronutrient deficiencies , notably in the elderly populations afflicted with AMD and their significant metabolic and health consequences , establishing efficient means of supplementation are of continuing epidemiologic interest .

###24332352
OBJECTIVE	To assess the impact of low-concentration contrast medium on vascular enhancement , image quality and radiation dose of coronary CT angiography ( cCTA ) by using a combination of iterative reconstruction ( IR ) and low-tube-voltage technique .
METHODS	One hundred patients were prospectively randomized to two types of contrast medium and underwent prospective electrocardiogram-triggering cCTA ( Definition Flash , Siemens Healthcare ; collimation : 128 mm 0.6 mm ; tube current : 300 mAs ) .
METHODS	Fifty patients received Iopromide 370 were scanned using the conventional tube setting ( 100 kVp or 120 kVp if BMI 25 kg/m ( 2 ) ) and reconstructed with filtered back projection ( FBP ) .
METHODS	Fifty patients received Iodixanol 270 were scanned using the low-tube-voltage ( 80 kVp or 100 kVp if BMI 25 kg/m ( 2 ) ) technique and reconstructed with IR .
METHODS	CT attenuation was measured in coronary artery and other anatomical regions .
METHODS	Noise , image quality and radiation dose were compared .
RESULTS	Compared with two Iopromide 370 subgroups , Iomeprol 270 subgroups showed no significant difference in CT attenuation ( 576.63 95.50 vs. 569.51 118.93 for BMI < 25 kg/m ( 2 ) , p = 0.647 and 394.19 68.09 vs. 383.72 63.11 for BMI 25 kg/m ( 2 ) , p = 0.212 ) , noise ( in various anatomical regions of interest ) and image quality ( 3.5 vs. 4.0 , p = 0.13 ) , but significantly ( 0.41 0.17 vs. 0.94 0.45 for BMI < 25 kg/m ( 2 ) , p < 0.001 and 1.14 0.24 vs. 2.37 0.69 for BMI 25 kg/m ( 2 ) , p < 0.001 ) lower radiation dose , which reflects dose saving of 56.4 % and 51.9 % , respectively .
CONCLUSIONS	Combined IR with low-tube-voltage technique , a low-concentration contrast medium of 270 mg I/ml can still maintain the contrast enhancement without impairing image quality , as well as significantly lower the radiation dose .

###24700256
OBJECTIVE	To test the hypothesis that those who are highly tolerant to lower body negative pressure ( LBNP ) while normothermic are also highly tolerant to this challenge while hyperthermic .
METHODS	Sixty pairs of normothermic and hyperthermic LBNP tests to pre-syncope were evaluated .
METHODS	LBNP tolerance was quantified via the cumulative stress index ( CSI ) , which is calculated as the sum of the product of the LBNP level and the duration of each level until test termination ( i.e. , 20mmHg3min +30 mmHg3min , etc. ) .
METHODS	CSI was compared between normothermic and hyperthermic trials .
METHODS	Internal and skin temperatures , heart rate , and arterial pressure were measured throughout .
RESULTS	Hyperthermia reduced ( P < 0.001 ) CSI from 997437 to 303213mmHgmin .
RESULTS	There was a positive correlation between normothermic and hyperthermic LBNP tolerance ( R ( 2 ) = 0.38 ; P < 0.001 ) .
RESULTS	As a secondary analysis , the 20 trials with the highest LBNP tolerance while normothermic were identified ( indicated as the HIGH group ; CSI 1,467356 mmHgmin ) , as were the 20 trials with the lowest normothermic tolerance ( indicated as the LOW group ; CSI 565166mmHgmin ; P < 0.001 between groups ) .
RESULTS	While hyperthermia unanimously reduced CSI in both HIGH and LOW groups , in this hyperthermic condition CSI was ~ threefold higher in the HIGH group ( 474226mmHgmin ) relative to the LOW group ( 160115mmHgmin ; P < 0.001 ) .
CONCLUSIONS	LBNP tolerance while hyperthermic is related to normothermic tolerance and , associated with this finding , those who have a high LBNP tolerance while normothermic remain relatively tolerant when hyperthermic .

###24814438
OBJECTIVE	Evaluate the role of midwife with no experience in assisting ultrasound guided embryo transfer .
METHODS	A prospective randomized study comparing results of IVF after ultrasound guided embryo transfer ( ET ) assisted either by a midwife with no formal training in US , or by a doctor trained to guide .
METHODS	ET procedure was performed on 553 patients undergoing ultrasound guided ET .
METHODS	The number of embryos transferred , the pregnancy rate ( PR ) , the incidence of extrauterine pregnancy , ongoing pregnancy rate , the implantation rate ( IR ) , difficulty of embryo transfer and quality of US assistance were compared among the groups .
RESULTS	No significant differences were observed between the two groups regarding the number of embryos transferred ( 2.5 +0.7 Group A vs 2.4 +0.8 Group B ) implantation rate ( 15.6 % Group A vs 15.2 % Group B ) , pregnancy rate ( 34.3 % Group A vs 36.2 % Group B ) , ongoing pregnancy rate ( 23.4 % Group A vs 23.9 % Group B ) , and rate of extrauterine pregnancies ( 1.4 % Group A vs 1 % Group B ) .
RESULTS	Difficult transfers ( 2.9 % Group A vs 3.6 % Group B ) and unsatisfactory visualization of uterus and catheter ( 6.2 % Group A vs 7.3 % Group B ) were also similar in both groups of patients .
CONCLUSIONS	Having an inexperienced nurse or midwife to perform ultrasound guidance during ET does not markedly affect the clinical results compared to using experienced clinicians for this purpose .

###25556460
OBJECTIVE	To explore the clinical effects of nimotuzumab combined with chemotherapy in the treatment of late gastric cancer .
METHODS	A total of 34 reoccurrence or metastatic patients with late stage gastric cancer who were confirmed by histopathology and/or cytology were selected and randomly divided into observational and control groups , of 17 cases each .
METHODS	Patients in the control group were treated with the standard DCF plan , while patients in observational group additionally received nimotuzumab .
METHODS	The short-term and long-term efficacy and adverse reactions in the 2 groups were followed .
RESULTS	The objective response rate ( ORR ) and disease control rate ( DCR ) were 64.7 % ( 11/17 ) and 82.4 % ( 14/17 ) in observational group and 25.0 % ( 4/16 ) and 37.5 % ( 6/16 ) in the control group ( ORR and DCR between 2 groups , 2 = 5.2412 , P = 0.0221 and 2 = 6.9453 , P = 0.0084 ) .
RESULTS	The median progression-free survival ( PFS ) time and median overall survival ( OS ) time were 6.50 months and 12.50 months in observational group and 4.50 months and 8.25 months in the control group ( P = 0.0212 ; P = 0.0255 ) .
RESULTS	The main toxic and side effects in the 2 groups were reduced leukocytes and hemoglobin , gastrointestinal reactions and hair loss and these were relieved after symptomatic treatment and nutrition support therapy .
RESULTS	There were no differences in the occurrence of toxic and side effects between the 2 groups .
CONCLUSIONS	Nimotuzumab combined with DCF plan is effective in treating late stage gastric cancer .
CONCLUSIONS	A larger scale study is now warranted for confirmation of the findings .

###24744162
OBJECTIVE	The JFMC33-0502 trial is a phase III clinical study designed to determine the most appropriate duration of postoperative adjuvant chemotherapy with uracil-tegafur ( UFT ) plus leucovorin in patients with stage IIB or III colon cancer .
OBJECTIVE	We report the interim results of preplanned safety analyses .
METHODS	Patients with stage IIB or III colon cancer who had undergone curative resection were randomly assigned to receive UFT ( 300 mg/m ( 2 ) ) plus leucovorin ( 75 mg/day ) for 6 months ( control group , 4 weeks of treatment followed by a 1-week rest , five courses ) or for 18 months ( study group , 5 days of treatment followed by a 2-day rest , 15 courses ) .
METHODS	Treatment status and safety were evaluated .
RESULTS	A total of 1,071 patients were enrolled , and 1,063 were included in safety analyses .
RESULTS	Treatment completion rate at 6 months was 74.0 % in the control group and 76.7 % in the study group .
RESULTS	Treatment completion rate in the study group at 18 months was 56.0 % .
RESULTS	The overall incidence of adverse events ( AEs ) was 75.3 % in the control group and 77.6 % in the study group .
RESULTS	The incidences of grade 3 or higher AEs were low in both groups .
RESULTS	During the first 6 months , the incidences of the subjective AEs were significantly lower in the study group .
CONCLUSIONS	Oral UFT plus leucovorin given by either dosage schedule is a very safe regimen for adjuvant chemotherapy .
CONCLUSIONS	In particular , 5 days of treatment followed by a 2-day rest was a useful treatment option from the viewpoint of toxicity even when given for longer than 6 months .

###25582112
OBJECTIVE	Image-enhanced endoscopy , such as narrow band imaging and the Storz Professional Image Enhancement System , have been increasingly used in patients with suspect lesions of the larynx and hypopharynx during preoperative and intraoperative assessment .
METHODS	In the present study , a contact endoscope was coupled with the systems of image-enhanced endoscopy , as to precisely distinguish the peculiar neoangiogenetic changes in inflammation , and precancerous and cancerous lesions of the larynx and hypopharynx .
METHODS	We performed a single-blind study with this original approach of a series of 44 patients with different lesions of the larynx and hypopharynx .
RESULTS	We observed five obvious vascular patterns matching the diagnosis in 41 patients out of 44 , with accuracy in the differential diagnosis between normal tissue and hyperplasia versus mild dysplasia and carcinoma of 97.6 % .
CONCLUSIONS	Enhanced contact endoscopy allows for predicting histologic changes of laryngeal and hypopharyngeal lesions from inflammation to cancer on based on fine evaluation of the neoangiogenetic changes of the chorion .
CONCLUSIONS	This innovative procedure can be considered an important tool during diagnosis , treatment , and follow-up of patients with precancer and cancer of the larynx and hypopharynx .

###24772585
BACKGROUND	Little is known about the effect of inhaled corticosteroids ( ICS ) / long-acting beta2 agonists ( LABA ) in combination on inflammatory markers in asthma .
BACKGROUND	In addition , therapeutic equivalence of generic salmeterol/fluticasone combination ( SFC ) and original SFC is as yet unknown .
OBJECTIVE	To determine the effects of SFC and the effects of generic and original SFC on airway inflammation in patients with mild-to moderate stable asthma .
METHODS	A randomized double-blinded , crossover non-inferiority study was conducted to compare the antiinflammatory effects of generic SFC and original SFC on sputum eosinophils as a primary outcome and fractional exhaled nitric oxide ( FENO ) as a secondary outcome .
METHODS	The authors studied 51 mild-to-moderate asthmatic patients who ranged from 18 to 80 years of age and were treated with ICS or ICS/LABA of any dose , and whose asthma was stable without an exacerbation episode for at least 3 months prior to study entry .
RESULTS	Both sputum eosinophils percentage and absolute eosinophil counts well correlated with FENO levels at baseline prior to the initiation of study medications .
RESULTS	Significant reduction in sputum eosinophil percentage was observed following generic SFC and original SFC treatment .
RESULTS	The degree of sputum eosinophil suppression by generic SFC was not inferior to original SFC , and this was not affected by treatments with the sequence of generic SFC first vs. original SFC second or original SFC first vs. generic SFC. In addition , there was no significant difference between treatments in terms of normalized gain in asthma control scores , including the number of patients found to have improved asthma control , irrespective of sequence , as change from baseline .
RESULTS	However , this was not the case for the magnitude of FENO reduction that occurred after generic SFC treatment to a significantly larger extent than original SFC treatment .
CONCLUSIONS	This short-term study demonstrated that there was no significant difference between generic SFC and original SFC in terms of anti-inflammatory activity and the control of asthma symptoms .
CONCLUSIONS	However , it is completely unknown whether generic SFC could effectively prevent the development of asthma exacerbations on a long-term basis .
CONCLUSIONS	Therefore , longer-term studies are indicated to evaluate generic SFC 's relative efficacy on asthma exacerbations .

###24786925
OBJECTIVE	Evaluate the safety and efficacy of longterm abatacept ( ABA ) treatment over 5 years in methotrexate ( MTX ) - refractory patients with rheumatoid arthritis ( RA ) .
METHODS	Patients from the 1-year , double-blind Abatacept in Inadequate Responders to Methotrexate ( AIM ) study ( NCT00048568 ) received open-label ABA ( 10 mg/kg ) in the longterm extension ( LTE ) .
METHODS	Safety was assessed for patients who received 1 ABA dose , and efficacy for patients randomized to ABA and treated in the LTE .
METHODS	Radiographs were evaluated for changes in Genant-modified Sharp scores .
RESULTS	Out of 652 patients , 539 entered the LTE ( ABA , n = 378 ; placebo , n = 161 ) .
RESULTS	At Year 5 , 72.4 % were ongoing ; discontinuation rates declined over time .
RESULTS	Incidence rates of serious adverse events , serious infections , malignancies , and autoimmune events were 13.87 , 2.84 , 1.45 , and 0.99 events/100 patient-years exposure , respectively .
RESULTS	American College of Rheumatology 20 response was 82.3 % ( n = 373 ) and 83.6 % ( n = 268 ) at years 1 and 5 , respectively .
RESULTS	Disease Activity Score 28 C-reactive protein ( DAS28-CRP ) < 2.6 and 3.2 were achieved by 25.4 % and 44.1 % of patients at Year 1 ( n = 370 ) , and 33.7 % and 54.7 % at Year 5 ( n = 267 ) , respectively .
RESULTS	Mean changes in DAS28-CRP and Health Assessment Questionnaire-Disability Index at Year 1 [ -2.83 ( n = 365 ) and -0.68 ( n = 369 ) ] were maintained at Year 5 [ -3.14 ( n = 264 ) and -0.77 ( n = 271 ) ] for patients continuing treatment .
RESULTS	Of them , 59.5 % ( n = 291 ) and 45.1 % ( n = 235 ) remained free from radiographic progression at years 1 and 5 , respectively .
CONCLUSIONS	In MTX-refractory patients with RA , longterm ABA treatment was well tolerated and provided consistent safety and sustained efficacy , with high patient retention .
CONCLUSIONS	Radiographic progression continued to be inhibited with ongoing treatment .

###24385121
OBJECTIVE	To determine whether field photodynamic therapy ( PDT ) of actinic keratoses ( AKs ) using a novel preparation of 5-aminolevulonic acid ( ALA ) would result in fewer subsequent invasive skin cancers developing on the face .
METHODS	A prospective multi-center randomized controlled trial .
METHODS	The protocol was approved by the Bond University Human Research Ethics Committee in accord with the TGA 's Clinical Trial Notification Scheme .
METHODS	The trial was registered ( 12609000025235 ) on the Australian New Zealand Clinical Trials Registry .
METHODS	Six centers in four states in Australia .
METHODS	Two treatments of ALA PDT , 2 weeks apart for each patient .
METHODS	Controls were observed .
METHODS	Patients were followed up with biopsies of any suspicious lesions every 6 months for 2 years .
METHODS	Development of new skin cancers .
RESULTS	The trial was suspended after 3 months and closed after 6 months after ethics committee approval was withdrawn on the basis of a breakdown in trial governance .
RESULTS	Over the following 2 years , some investigators noted and formally reported the continued occurrence of serious adverse events in excess of those described with other approved cutaneous PDT treatments .
RESULTS	USA dermatologists with experience managing AKs with FDA approved ALA products subsequently confirmed prolonged and severe adverse events in 6 of the former trial intervention patients .
CONCLUSIONS	Adverse effects experienced by patients using the investigational ALA PDT appeared more severe than those experienced when an FDA-approved ALA product is used .
CONCLUSIONS	We believe the former should be further evaluated for safety .
CONCLUSIONS	It is of concern that this ALA product and lamp could be promoted and used widely in Australia following these reports of significant adverse events and continued lack of TGA approval .

###24232638
BACKGROUND	Childhood obesity can cause the development of cardiovascular risk factors .
BACKGROUND	We assessed the effect of a multidisciplinary intervention program on cardiovascular risk factors and compared this effect with a usual-care program in 3 - to 5-y-old overweight or obese children .
METHODS	Seventy-five children were randomly assigned to a multidisciplinary intervention or a usual-care program .
METHODS	Anthropometry , body composition , and abdominal adipose tissue were assessed at the start and end of a 16-wk program .
METHODS	Concurrently , fasting concentrations of serum lipids , glucose , insulin , HbA1c , leptin , adiponectin , high-sensitive C-reactive protein ( hsCRP ) , tumor necrosis factor ( TNF ) - , and interleukin ( IL ) -6 were determined .
RESULTS	In both groups , insulin sensitivity improved , demonstrated by decreased insulin concentrations and a decreased HOMA2-IR .
RESULTS	In the multidisciplinary intervention group , there was also a decrease of HbA1c and TNF - .
RESULTS	In the usual-care group , an increase in glucose concentrations was found .
RESULTS	Comparing both groups , changes over time were not different , besides trends in the decrease in total cholesterol and TNF - , in favor of the multidisciplinary intervention group .
RESULTS	Combining the results of both groups , a correlation was found between the decrease in body fat percentage ( BF % ) , and both HOMA2-IR and triglyceride ( TG ) concentrations .
CONCLUSIONS	In 3 - to 5-y-old children , both obesity intervention programs improved insulin sensitivity , in parallel with a reduced BF % .

###25909567
OBJECTIVE	Over the last decade , image guidance systems have been widely adopted in neurosurgery .
OBJECTIVE	Nonetheless , the evidence supporting the use of these systems in surgery remains limited .
OBJECTIVE	The aim of this study was to compare simultaneously the effectiveness and safety of various image guidance systems against that of standard surgery .
METHODS	In this preclinical , randomized study , 50 novice surgeons were allocated to one of the following groups : 1 ) no image guidance , 2 ) triplanar display , 3 ) always-on solid overlay , 4 ) always-on wire mesh overlay , and 5 ) on-demand inverse realism overlay .
METHODS	Each participant was asked to identify a basilar tip aneurysm in a validated model head .
METHODS	The primary outcomes were time to task completion ( in seconds ) and tool path length ( in mm ) .
METHODS	The secondary outcomes were recognition of an unexpected finding ( i.e. , a surgical clip ) and subjective depth perception using a Likert scale .
RESULTS	The time to task completion and tool path length were significantly lower when using any form of image guidance compared with no image guidance ( p < 0.001 and p = 0.003 , respectively ) .
RESULTS	The tool path distance was also lower in groups using augmented reality compared with triplanar display ( p = 0.010 ) .
RESULTS	Always-on solid overlay resulted in the greatest inattentional blindness ( 20 % recognition of unexpected finding ) .
RESULTS	Wire mesh and on-demand overlays mitigated , but did not negate , inattentional blindness and were comparable to triplanar display ( 40 % recognition of unexpected finding in all groups ) .
RESULTS	Wire mesh and inverse realism overlays also resulted in better subjective depth perception than always-on solid overlay ( p = 0.031 and p = 0.008 , respectively ) .
CONCLUSIONS	New augmented reality platforms may improve performance in less-experienced surgeons .
CONCLUSIONS	However , all image display modalities , including existing triplanar displays , carry a risk of inattentional blindness .

###25317087
OBJECTIVE	Fluid displacement from the legs during recumbency while in bed might narrow the upper airway ( UA ) in association with nuchal fluid accumulation that may contribute to the pathogenesis of obstructive sleep apnea ( OSA ) .
OBJECTIVE	The aim of this study was to test the hypothesis that rostral fluid displacement from the legs causes a greater decrease in UA cross-sectional area ( UA-XSA ) and a greater increase in UA mucosal water content ( UA-MWC ) and internal jugular venous volume ( IJVVol ) in subjects with OSA than in those without OSA .
METHODS	Subjects underwent baseline assessment of leg fluid volume ( LFV ) measured by bio-electrical impedance , as well as UA-XSA and UA-MWC by magnetic resonance imaging .
METHODS	They were then randomly assigned to a 20-min period either with or without application of lower body positive pressure ( LBPP ) of 40 mm Hg , followed by a 15-min washout period , after which they crossed over to the other arm of the study .
METHODS	Measurements of LFV , UA-MWC , and UA-XSA were repeated after each arm of the study .
RESULTS	In 12 subjects without sleep apnea , UA-XSA increased and UA-MWC decreased significantly , whereas in 12 subjects with OSA , UA-XSA decreased and UA-MWC increased significantly in response to LBPP .
RESULTS	The changes in UA-XSA and UA-MWC in response to LBPP differed significantly between the 2 groups ( p = 0.006 and p < 0.001 , respectively ) , despite similar changes in LFV and IJVVol .
CONCLUSIONS	Our results suggest that rostral fluid shift may contribute to the pathogenesis of OSA at least partly through narrowing of the UA due to transudation of fluid into the UA mucosa .

###24232511
OBJECTIVE	To test the hypothesis that the use of a harmonic scalpel increases operative time but results in less estimated blood loss , postoperative pain , drainage volume , and duration of surgery , as well as fewer complications , such as flap necrosis , seroma , and surgical site infection ( SSI ) , than electrocautery .
METHODS	This parallel-group , single-institution blinded randomized controlled trial was conducted at the department of surgery of our institute between April 2010 and July 2011 .
METHODS	Women undergoing modified radical mastectomy were randomly allocated to either harmonic dissection ( n = 76 ) or electrocautery ( n = 76 ) .
RESULTS	Both the groups were comparable for baseline variables with age of 50.5 12.2 and 48.5 14.5 years in the harmonic and electrocautery groups , respectively .
RESULTS	Harmonic dissection yielded better outcomes compared to electrocautery with lower estimated blood loss ( 100 62 vs. 182 92 , p < 0.001 ) , less drain volume ( 631 275 ml vs. 1035 413 ml , p < 0.001 ) , fewer drain days ( 12 3 vs. 17 4 , p < 0.001 ) , less seroma formation ( 21.3 vs. 33.3 % , p = 0.071 ) , and less postoperative pain [ median ( interquartile range ) 2 ( 2-2 ) vs. 3 ( 3-4 ) , p < 0.001 ] , whereas mean operative time ( 191 44 vs. 187 36 min , p = 0.49 ) and SSI ( 0 vs. 4 % , p = 0.122 ) did not differ .
RESULTS	On multivariable Cox regression analysis , harmonic dissection was associated with lower risk of significant postoperative pain [ adjusted relative risk 0.028 ( 95 % confidence interval ( CI ) 0.004-0 .2 ) ] and overall complications [ adjusted relative risk 0.47 , ( 95 % CI 0.26-0 .86 ) ] .
RESULTS	On multiple linear regression , duration of drains in the harmonic dissection group was 4.5 days less than electrocautery ( r2 = 0.28 , = 11.8 , p < 0.001 ) .
CONCLUSIONS	The harmonic scalpel significantly reduces postoperative discomfort and morbidity to the patient without increasing operating time .
CONCLUSIONS	We thus recommend preferential use of harmonic dissection in modified radical mastectomy .
CONCLUSIONS	( ClinicalTrials.gov NCT01587248 ) .

###25248358
OBJECTIVE	The prevalence of metabolic syndrome ( MetS ) and obesity has increased worldwide , as well as in Taiwan , particularly in women aged > 40 years .
OBJECTIVE	The purpose of this study was to elucidate the effects of a calorie-restriction diet ( CR ) supplemented with protein and n-3 polyunsaturated fatty acids ( PUFAs ) on women with MetS .
METHODS	A total of 143 eligible female participants were recruited and assigned to four dietary interventions such as 1500-kcal CR , calorie-restriction meal-replacement diet ( CRMR ) , calorie-restriction diet with fish oil supplementation ( CRF ) and calorie-restriction meal-replacement diet with fish oil supplementation ( CRMRF ) .
METHODS	The changes in anthropometric measures , metabolic profiles , inflammatory response and the Z-score of severity of MetS were evaluated .
RESULTS	Among 143 female MetS patients enrolled , 136 patients completed the 12-week study .
RESULTS	After the 12-week dietary interventions , we observed reductions in body weight ( BW ) , body mass index ( BMI ) and waist circumference ( WC ) in all groups .
RESULTS	BMI and triglyceride ( TG ) levels decreased significantly in the CRMR , CRF and CRMRF groups , but not in the CR group .
RESULTS	The homeostasis model assessment of insulin resistance ( HOMA-IR ) had significantly improved in all four groups , and the levels of interleukin-6 ( IL-6 ) and C-reactive protein ( CRP ) had significantly decreased in the CRF and CRMRF groups .
RESULTS	Following the interventions , the changes in waist circumference ( WC ) , mean arterial pressure ( MAP ) , fasting blood glucose ( FBG ) , TGs , HOMA-IR , CRP and IL-6 significantly correlated with the reductions in Z-score of MetS severity .
CONCLUSIONS	Our study results indicate that a calorie-restriction dietary intervention combined with various macronutrients can reduce the severity of MetS in women and increase recovery from MetS by almost twofold in comparison with a CR alone .

###24828121
OBJECTIVE	Driving is a complex task and distractions such as using a mobile phone for the purpose of text messaging are known to have a significant impact on driving .
OBJECTIVE	Eating and drinking are common forms of distraction that have received less attention in relation to their impact on driving .
OBJECTIVE	The aim of this study was to further explore and compare the effects of a variety of distraction tasks ( i.e. , text messaging , eating , drinking ) on simulated driving .
METHODS	Twenty-eight healthy individuals ( 13 female ) participated in a crossover design study involving 3 experimental trials ( separated by 24 h ) .
METHODS	In each trial , participants completed a baseline driving task ( no distraction ) before completing a second driving task involving one of 3 different distraction tasks ( drinking 400 mL water , drinking 400 mL water and eating a 6-inch Subway sandwich , drinking 400 mL water and composing 3 text messages ) .
METHODS	Primary outcome measures of driving consisted of standard deviation of lateral position ( SDLP ) and reaction time to auditory and visual critical events .
METHODS	Subjective ratings of difficulty in performing the driving tasks were also collected at the end of the study to determine perceptions of distraction difficulty on driving .
RESULTS	Driving tasks involving texting and eating were associated with significant impairment in driving performance measures for SDLP compared to baseline driving ( 46.0 0.08 vs. 41.3 0.06 cm and 44.8 0.10 vs. 41.6 0.07 cm , respectively ) , number of lane departures compared to baseline driving ( 10.9 7.8 vs. 7.6 7.1 and 9.4 7.5 vs. 7.1 7.0 , respectively ) , and auditory reaction time compared to baseline driving ( 922 95 vs. 889 104 ms and 933 101 vs. 901 103 ms , respectively ) .
RESULTS	No difference in SDLP ( 42.7 0.08 vs. 42.5 0.07 cm ) , number of lane departures ( 7.6 7.7 vs. 7.0 6.8 ) , or auditory reaction time ( 891 98 and 885 89 ms ) was observed in the drive involving the drink-only condition compared to the corresponding baseline drive .
RESULTS	No difference in reaction time to visual stimuli was observed between baseline and experimental drives for any of the trial conditions .
RESULTS	Participants ' subjective ratings indicated that they perceived the texting while driving condition to be the most difficult despite similar magnitudes of impairment observed with the eating while driving condition .
CONCLUSIONS	Distracting behaviors such as eating and texting while driving appear to negatively impact driving measures of lane position control and reaction time .
CONCLUSIONS	These findings may have direct implications for motorists that engage in these types of distracting behaviors behind the wheel and for the safety of other road users .

###24820007
BACKGROUND	Open abdominal aortic aneurysm ( AAA ) repair is followed by a high rate of incisional herniation .
BACKGROUND	The purpose of this study was to evaluate whether this postoperative complication could be avoided by a prophylactic implantation of a biological mesh .
METHODS	In a prospective randomized clinical study , patients electively treated by open AAA repair were allocated equally to routine abdominal suture closure or to prophylactic placement of bovine pericardium mesh above the fascia .
METHODS	The study end points were postoperative complications and incidence of incisional hernia at a 3-year follow up .
RESULTS	Forty patients with a mean age of 74.3 ( SD 5.8 ) years were studied .
RESULTS	All patients had a successful operation and a quite uneventful postoperative course .
RESULTS	The mean operative time in the mesh group was longer compared to the control group ( p < 0.001 ) .
RESULTS	Two patients in the mesh group developed wound seroma postoperatively .
RESULTS	Six patients ( 30 % ) in the control group developed incisional hernia comparing to none in the mesh group .
RESULTS	Cumulative proportion of freedom from incisional hernia was 100 % for mesh group at 3 years and 74.4 % ( SE 9.9 % ) for control group at 2 years ( p < 0.008 ) .
RESULTS	In five patients ( 83 % ) , the incisional hernia was diagnosed by the second postoperative year .
RESULTS	One patient underwent incisional hernia repair .
CONCLUSIONS	The bovine pericardium mesh reinforcement of fascia closure in patients undergoing open AAA repair showed effectiveness and low complication rate in prophylaxis from incisional herniation .
CONCLUSIONS	It should be considered as an alternative mesh material in selected patients .

###25209610
OBJECTIVE	The therapeutic arsenal for MRSA infections is limited .
OBJECTIVE	The aim of this study was to assess the non-inferiority of a combination of trimethoprim/sulfamethoxazole plus rifampicin versus linezolid alone for the treatment of MRSA infection .
METHODS	We conducted a randomized , open-label , single-centre , non-inferiority trial comparing trimethoprim/sulfamethoxazole ( 160 mg/800 mg three times daily ) plus rifampicin ( 600 mg once a day ) versus linezolid ( 600 mg twice a day ) alone in adult patients with various types of MRSA infection .
METHODS	Patients were allocated 1:1 to either regimen .
METHODS	The primary outcome was clinical cure at 6 weeks after the end of treatment ( non-inferiority margin 20 % ) assessed by both ITT and PP analyses .
METHODS	Secondary outcomes included the microbiologically documented persistence of MRSA in clinical cultures , mortality and adverse events .
METHODS	The study protocol has been registered with ClinicalTrials.gov ( NCT00711854 ) .
RESULTS	Overall , 150 patients were randomized to one of the two treatment arms between January 2009 and December 2013 and were included in the ITT analysis .
RESULTS	Of these 56/75 ( 74.7 % ) in the linezolid group and 59/75 ( 78.7 % ) in the trimethoprim/sulfamethoxazole and rifampicin group experienced clinical success ( risk difference 4 % , 95 % CI -9.7 % to 17.6 % ) .
RESULTS	The results were confirmed by the PP analysis , with 54/66 ( 81.8 % ) cured patients in the linezolid group versus 52/59 ( 88.1 % ) in the trimethoprim/sulfamethoxazole and rifampicin group ( risk difference 6.3 % , 95 % CI -6.8 % to 19.2 % ) .
RESULTS	There were no statistically significant differences between the two groups in any of the secondary outcomes , including microbiologically documented failure .
RESULTS	Four adverse drug reactions attributed to the study medication occurred in the linezolid group versus nine in the trimethoprim/sulfamethoxazole and rifampicin group .
CONCLUSIONS	Compared with linezolid , trimethoprim/sulfamethoxazole and rifampicin seems to be non-inferior in the treatment of MRSA infection .

###26075752
BACKGROUND	Antiretroviral therapy initiation for HIV-1 infection is associated with 2 % to 6 % loss of bone mineral density ( BMD ) .
OBJECTIVE	To evaluate the effect of vitamin D3 plus calcium supplementation on bone loss associated with antiretroviral therapy initiation .
METHODS	48-week prospective , randomized , double-blind , placebo-controlled study .
METHODS	( ClinicalTrials.gov : NCT01403051 ) .
METHODS	39 AIDS Clinical Trials Group units .
METHODS	Adults with antiretroviral therapy-naive HIV .
METHODS	BMD by dual-energy x-ray absorptiometry , 25-hydroxyvitamin D levels , and other laboratory assessments .
RESULTS	165 eligible patients were randomly assigned ( 79 received vitamin D3 plus calcium and 86 received placebo ) .
RESULTS	The study groups were well-balanced at baseline : 90 % were men , 33 % were non-Hispanic black , and the median CD4 count was 0.341 109 cells/L .
RESULTS	At 48 weeks , the percentage of decline in total hip BMD was smaller in the vitamin D3 plus calcium group than in the placebo group : Medians were -1.36 % ( interquartile range [ IQR ] , -3.43 % to 0.50 % ) and -3.22 % ( IQR , -5.56 % to -0.88 % ) , respectively ( P = 0.004 ) .
RESULTS	Similar results were seen at the lumbar spine .
RESULTS	At 48 weeks , 90 % of patients achieved HIV-1 RNA levels less than 50 copies/mL .
RESULTS	Levels of 25-hydroxyvitamin D3 increased with vitamin D3 plus calcium but not with placebo : Median change was 61.2 nmol/L ( IQR , 36.4 to 94.3 ) versus 1.7 nmol/L ( IQR , -13.2 to 10.7 ) ( P < 0.001 ) .
RESULTS	Overall , 103 patients ( 62 % ) reported 1 or more adverse event , with similar distribution between groups ; no cases of hypercalcemia and 1 case of nephrolithiasis were reported in the placebo group .
CONCLUSIONS	No international sites were included , and follow-up was only 48 weeks .
CONCLUSIONS	Vitamin D3 plus calcium supplementation mitigates the BMD loss seen with initiation of efavirenz/emtricitabine/tenofovir disoproxil fumarate .

###24818608
OBJECTIVE	This article describes an experiment that was designed to investigate the effects of sleep deprivation on physiological stress responses in healthy adults .
METHODS	Twenty-six participants , ages 22-49 , completed a 3-night laboratory experiment with randomization to one night of sleep-deprivation or a normal-sleep control condition .
METHODS	After a night of baseline sleep , 12 participants were sleep deprived and 14 were not .
METHODS	After the sleep manipulation , each participant completed the Trier Social Stress Test , a task that requires delivering a speech and performing difficult arithmetic in front of a stern , three-person panel .
METHODS	The stressor was administered from 5:00 p.m.-5 :30 p.m. and saliva samples were collected 20 and 5 min before ( baseline ) and 5 , 20 , and 40 min after the stressor .
METHODS	Samples were assayed for cortisol ( a biomarker for the HPA axis ) and alpha-amylase ( a putative biomarker for the sympatho-adrenal medullar system ) .
RESULTS	Sleep deprivation was associated with higher cortisol levels at baseline ( p < .0001 ) and an amplified cortisol response to the stressor relative to control participants ( pinteraction = 0.0039 ) .
RESULTS	Alpha-amylase showed a significant main effect of the stressor ( p = .0026 ) , but there was no effect of sleep loss at baseline or in response to the stressor .
CONCLUSIONS	Sleep deprivation is associated with both elevated resting cortisol release and with an exaggerated cortisol response to a stressor indicative of elevated HPA axis responses in healthy adults .
CONCLUSIONS	Individual differences in the magnitude of this response may represent a risk factor for psychological and physical health consequences associated with heightened cortisol exposure .

###26034248
BACKGROUND	Changes in health care delivery create opportunities to improve systems to better meet the needs of low-income families while achieving quality benchmarks .
METHODS	Families of healthy newborns receiving primary care at a single large urban safety-net hospital participated .
METHODS	Intervention families were randomly assigned a family specialist who provided support until the 6-month routine health care visit .
METHODS	The Developmental Understanding and Legal Collaboration for Everyone ( DULCE ) intervention is based on the Strengthening Families approach and incorporated components of the Healthy Steps and Medical-Legal Partnership models .
METHODS	Medical record reviews determined use of preventive and emergency care .
METHODS	Surveys conducted at baseline , postintervention ( 6 months ) , and follow-up ( 12 months ) were used to determine hardship and attainment of concrete supports .
RESULTS	Three hundred thirty families participated in the study .
RESULTS	At baseline , 73 % of families reported economic hardships .
RESULTS	Intervention parents had an average of 14 contacts with the family specialist , and 5 hours of total contact time .
RESULTS	Intervention infants were more likely to have completed their 6-month immunization schedule by age 7 months ( 77 % vs 63 % , P < .005 ) and by 8 months ( 88 % vs 77 % , P < .01 ) .
RESULTS	Intervention infants were more likely to have 5 or more routine preventive care visits by age 1 year ( 78 % vs 67 % , P < .01 ) and were less likely to have visited the emergency department by age 6 months ( 37 % vs 49.7 % , P < .03 ) .
RESULTS	The DULCE intervention accelerated access to concrete resources ( P = .029 ) .
CONCLUSIONS	Assignment to the Project DULCE intervention led to improvements in preventive health care delivery and utilization and accelerated access to concrete supports among low-income families .

###24483158
BACKGROUND	Foot ulcer is the principal cause of hospitalization for patients with diabetes .
BACKGROUND	Polydeoxyribonucleotide ( PDRN ) , an adenosine A2A receptor agonist , improves wound healing in diabetic mice .
OBJECTIVE	The aim of this study was to evaluate the effect of PDRN on chronic ulcer healing in patients with diabetes .
METHODS	This randomized , double-blind , placebo-controlled trial , involved two medical centers in Italy .
METHODS	Patients with diabetes showing hard-to-heal ulcers ( Wagner grade 1 or 2 ) were randomly assigned to receive placebo ( n = 106 ) or PDRN ( n = 110 ) .
METHODS	The treatments ( PDRN and placebo ) were performed for 8 weeks by intramuscular and perilesional route [ corrected ] .
METHODS	The primary outcome was complete ulcer healing .
METHODS	Secondary outcomes were the days needed to complete wound closure and the reepithelialization of wound surface ( as percentage of the original area ) .
RESULTS	After 8 weeks , 91 placebo and 101 PDRN subjects completed the study .
RESULTS	Complete healing was achieved in 18.9 % [ 95 % confidence interval ( CI ) 11.4-26 .3 ] of placebo and in 37.3 % ( 95 % CI 28.2-46 .3 ) of PDRN-treated patients ( P = .0027 ) .
RESULTS	After 8 weeks , PDRN increased the closure of foot ulcers in diabetic subjects ( hazard ratio 2.20 ; 95 % CI 1.29-3 .75 ; P = .004 ) .
RESULTS	The median time to complete wound healing was 49 days for placebo ( range 28-56 d ) and 30 days for PDRN-treated subjects ( range 14-56 d ; P = .0027 ) .
RESULTS	The median epithelialized area of the ulcers ( expressed as percentage ) was 49.3 % in the placebo and 82.2 % in the PDRN group ( P < .001 ) .
CONCLUSIONS	PDRN facilitates the healing of Wagner 1 or 2 diabetic foot ulcers .

###24892144
BACKGROUND	Although recent studies have identified the presence of phenotypic clusters in asthmatic patients , the clinical significance and temporal stability of these clusters have not been explored .
OBJECTIVE	Our aim was to examine the clinical relevance and temporal stability of phenotypic clusters in children with asthma .
METHODS	We applied spectral clustering to clinical data from 1041 children with asthma participating in the Childhood Asthma Management Program .
METHODS	Posttreatment randomization follow-up data collected over 48 months were used to determine the effect of these clusters on pulmonary function and treatment response to inhaled anti-inflammatory medication .
RESULTS	We found 5 reproducible patient clusters that could be differentiated on the basis of 3 groups of features : atopic burden , degree of airway obstruction , and history of exacerbation .
RESULTS	Cluster grouping predicted long-term asthma control , as measured by the need for oral prednisone ( P < .0001 ) or additional controller medications ( P = .001 ) , as well as longitudinal differences in pulmonary function ( P < .0001 ) .
RESULTS	We also found that the 2 clusters with the highest rates of exacerbation had different responses to inhaled corticosteroids when compared with the other clusters .
RESULTS	One cluster demonstrated a positive response to both budesonide ( P = .02 ) and nedocromil ( P = .01 ) compared with placebo , whereas the other cluster demonstrated minimal responses to both budesonide ( P = .12 ) and nedocromil ( P = .56 ) compared with placebo .
CONCLUSIONS	Phenotypic clustering can be used to identify longitudinally consistent and clinically relevant patient subgroups , with implications for targeted therapeutic strategies and clinical trials design .

###25367545
BACKGROUND	There is growing interest in clinical screening for pediatric social determinants of health , but little evidence on formats that maximize disclosure rates on a wide range of potentially sensitive topics .
BACKGROUND	We designed a study to examine disclosure rates and hypothesized that there would be no difference in disclosure rates on face-to-face versus electronic screening formats for items other than highly sensitive items .
METHODS	We conducted a randomized trial of electronic versus face-to-face social screening formats in a pediatric emergency department .
METHODS	Consenting English-speaking and Spanish-speaking adult caregivers familiar with the presenting child 's household were randomized to social screening via tablet computer ( with option for audio assist ) versus a face-to-face interview conducted by a fully bilingual/bicultural researcher .
RESULTS	Almost all caregivers ( 96.8 % ) reported at least 1 social need , but rates of reporting on the more sensitive issues ( household violence and substance abuse ) were significantly higher in electronic format , and disclosure was marginally higher in electronic format for financial insecurity and neighborhood and school safety .
RESULTS	There was a significant difference in the proportion of social needs items with higher endorsement in the computer-based group ( 70 % ) than the face-to-face group ( 30 % ) .
CONCLUSIONS	Pediatric clinical sites interested in incorporating caregiver-reported socioeconomic , environmental , and behavioral needs screening should consider electronic screening when feasible , particularly when assessing sensitive topics such as child safety and household member substance use .

###24667559
BACKGROUND	Cardiovascular disease risk increases when lipoprotein metabolism is dysfunctional .
BACKGROUND	We have developed a computational model able to derive indicators of lipoprotein production , lipolysis , and uptake processes from a single lipoprotein profile measurement .
BACKGROUND	This is the first study to investigate whether lipoprotein metabolism indicators can improve cardiovascular risk prediction and therapy management .
RESULTS	We calculated lipoprotein metabolism indicators for 1981 subjects ( 145 cases , 1836 controls ) from the Framingham Heart Study offspring cohort in which NMR lipoprotein profiles were measured .
RESULTS	We applied a statistical learning algorithm using a support vector machine to select conventional risk factors and lipoprotein metabolism indicators that contributed to predicting risk for general cardiovascular disease .
RESULTS	Risk prediction was quantified by the change in the Area-Under-the-ROC-Curve ( AUC ) and by risk reclassification ( Net Reclassification Improvement ( NRI ) and Integrated Discrimination Improvement ( IDI ) ) .
RESULTS	Two VLDL lipoprotein metabolism indicators ( VLDLE and VLDLH ) improved cardiovascular risk prediction .
RESULTS	We added these indicators to a multivariate model with the best performing conventional risk markers .
RESULTS	Our method significantly improved both CVD prediction and risk reclassification .
CONCLUSIONS	Two calculated VLDL metabolism indicators significantly improved cardiovascular risk prediction .
CONCLUSIONS	These indicators may help to reduce prescription of unnecessary cholesterol-lowering medication , reducing costs and possible side-effects .
CONCLUSIONS	For clinical application , further validation is required .

###24420765
OBJECTIVE	The objective of this study was to determine the feasibility and effectiveness of working memory ( WM ) training in college students with ADHD or learning disabilities ( LD ) .
METHODS	A total of 62 students ( 21 males , 41 females ) were randomized to a 5-week intensive WM training program or a wait-list control group .
METHODS	Participants were evaluated before treatment , 3 weeks after completion , and at 2-month follow-up .
METHODS	The criterion measures were standardized tests of auditory-verbal and visual-spatial WM. Near transfer measures included other cognitive tasks ; far transfer measures included academic tasks and behavioral rating scales .
RESULTS	Intent-to-treat analysis revealed that participants receiving WM training showed significantly greater improvements on the criterion WM measures and self-reported fewer ADHD symptoms and cognitive failures .
RESULTS	The follow-up assessment indicated that gains in WM were maintained , as were improvements in cognitive failures .
CONCLUSIONS	Computerized WM training is a feasible and possibly viable approach for enhancing WM in college students with ADHD or LD .

###24947924
OBJECTIVE	Randomized ovarian cancer trials , including ICON7 , have reported improved progression-free survival ( PFS ) when bevacizumab was added to conventional cytotoxic therapy .
OBJECTIVE	The improvement was modest prompting the search for predictive biomarkers for bevacizumab .
METHODS	Pretreatment training ( n = 91 ) and validation ( n = 114 ) blood samples were provided by ICON7 patients .
METHODS	Plasma concentrations of 15 angio-associated factors were determined using validated multiplex ELISAs .
METHODS	Our statistical approach adopted PFS as the primary outcome measure and involved ( i ) searching for biomarkers with prognostic relevance or which related to between-individual variation in bevacizumab effect ; ( ii ) unbiased determination of cutoffs for putative biomarker values ; ( iii ) investigation of biologically meaningfully predictive combinations of putative biomarkers ; and ( iv ) replicating the analysis on candidate biomarkers in the validation dataset .
RESULTS	The combined values of circulating Ang1 ( angiopoietin 1 ) and Tie2 ( Tunica internal endothelial cell kinase 2 ) concentrations predicted improved PFS in bevacizumab-treated patients in the training set .
RESULTS	Using median concentrations as cutoffs , high Ang1/low Tie2 values were associated with significantly improved PFS for bevacizumab-treated patients in both datasets ( median , 23.0 months vs. 16.2 ; P = 0.003 ) for the interaction of Ang1-Tie2 treatment in Cox regression analysis .
RESULTS	The prognostic indices derived from the training set also distinguished high and low probability for progression in the validation set ( P = 0.008 ) , generating similar values for HR ( 0.21 vs. 0.27 ) between treatment and control arms for patients with high Ang1 and low Tie2 values .
CONCLUSIONS	The combined values of Ang1 and Tie2 are predictive biomarkers for improved PFS in bevacizumab-treated patients with ovarian cancer .
CONCLUSIONS	These findings need to be validated in larger trials due to the limitation of sample size in this study .

###25205320
BACKGROUND	This pilot study investigates the efficacy of a probiotic consortium ( Lab4 ) in combination with vitamin C on the prevention of respiratory tract infections in children attending preschool facilities .
METHODS	In a double-blind , randomised , placebo-controlled pilot study with children aged 3-6 years , 57 received 1.25 10 ( 10 ) colony-forming units of Lactobacillus acidophilus CUL21 ( NCIMB 30156 ) , Lactobacillus acidophilus CUL60 ( NCIMB 30157 ) , Bifidobacterium bifidum CUL20 ( NCIMB 30153 ) and Bifidobacterium animalis subsp .
METHODS	lactis CUL34 ( NCIMB 30172 ) plus 50mg vitamin C or a placebo daily for 6 months .
RESULTS	Significant reductions in the incidence rate of upper respiratory tract infection ( URTI ; 33 % , P = 0.002 ) , the number of days with URTI symptoms ( mean difference : -21.0 , 95 % confidence interval ( CI ) : -35.9 , -6.0 , P = 0.006 ) and the incidence rate of absence from preschool ( 30 % , P = 0.007 ) were observed in the active group compared with the placebo .
RESULTS	The number of days of use of antibiotics , painkillers , cough medicine or nasal sprays was lower in the active group and reached significance for use of cough medicine ( mean difference : -6.6 , 95 % CI : -12.9 , -0.3 , P = 0.040 ) .
RESULTS	No significant differences were observed in the incidence rate ratio or duration of lower respiratory tract infection or in the levels of plasma cytokines , salivary immunoglobulin A or urinary metabolites .
CONCLUSIONS	Supplementation with a probiotic/vitamin C combination may be beneficial in the prevention and management of URTIs .

###25041791
BACKGROUND	Targeting a single pathway in pancreatic adenocarcinoma ( PC ) is unlikely to affect its natural history .
BACKGROUND	We tested the hypothesis that simulataneous targeting of the epidermal growth factor receptor ( EGFR ) and insulin-like growth factor receptor-1 ( IGF-1R ) pathways would significantly improve progression-free survival ( PFS ) by abrogating reciprocal signaling that promote drug resistance
METHODS	This was a phase Ib/II study testing cixutumumab , combined with erlotinib and gemcitabine ( G ) in patients with untreated metastatic PC .
METHODS	The control arm was erlotinib plus G.
METHODS	The primary end point was PFS .
METHODS	Eligibility included performance status 0/1 and normal fasting blood glucose .
METHODS	Polymorphisms in genes involved in G metabolism and in the EGFR pathway were also studied
RESULTS	The phase I results ( n = 10 ) established the safety of cixutumumab 6 mg/kg/week intravenously , erlotinib 100 mg/day orally , and G 1000 mg/m ( 2 ) intravenously on days 1 , 8 , and 15 of a 28-day cycle .
RESULTS	In the RP2 portion ( 116 eligible patients ; median age , 63 ) , the median PFS and overall survival ( OS ) were 3.6 and 7.0 months , respectively , on the cixutumumab arm , and 3.6 and 6.7 months , respecively , on the control arm .
RESULTS	Major grades 3 and 4 toxicities with cixutumumab and control were elevation of transaminases , 12 % and 6 % , respectively ; fatigue , 16 % and 12 % , respectively ; gastrointestinal , 35 % and 28 % , respectively ; neutropenia , 21 % and 10 % , respectively ; and thrombocytopenia , 16 % and 7 % , respecively .
RESULTS	Grade 3/4 hyperglycemia was seen in 16 % of patients on cixutumumab .
RESULTS	Grade 3 or 4 skin toxicity was similar in both arms of the study ( < 5 % ) .
RESULTS	No significant differences in PFS by genotype were seen for any of the polymorphisms .
CONCLUSIONS	Adding the IGF-1R inhibitor cixutumumab to erlotinib and G did not lead to longer PFS or OS in metastatic PC .

###25107467
BACKGROUND	Conflicting evidence exists regarding the association between saturated fatty acids ( SFAs ) and type 2 diabetes .
BACKGROUND	In this longitudinal case-cohort study , we aimed to investigate the prospective associations between objectively measured individual plasma phospholipid SFAs and incident type 2 diabetes in EPIC-InterAct participants .
METHODS	The EPIC-InterAct case-cohort study includes 12,403 people with incident type 2 diabetes and a representative subcohort of 16,154 individuals who were selected from a cohort of 340.234 European participants with 399 million person-years of follow-up ( the EPIC study ) .
METHODS	Incident type 2 diabetes was ascertained until Dec 31 , 2007 , by a review of several sources of evidence .
METHODS	Gas chromatography was used to measure the distribution of fatty acids in plasma phospholipids ( mol % ) ; samples from people with type 2 diabetes and subcohort participants were processed in a random order by centre , and laboratory staff were masked to participant characteristics .
METHODS	We estimated country-specific hazard ratios ( HRs ) for associations per SD of each SFA with incident type 2 diabetes using Prentice-weighted Cox regression , which is weighted for case-cohort sampling , and pooled our findings using random-effects meta-analysis .
RESULTS	SFAs accounted for 46 % of total plasma phospholipid fatty acids .
RESULTS	In adjusted analyses , different individual SFAs were associated with incident type 2 diabetes in opposing directions .
RESULTS	Even-chain SFAs that were measured ( 14:0 [ myristic acid ] , 16:0 [ palmitic acid ] , and 18:0 [ stearic acid ] ) were positively associated with incident type 2 diabetes ( HR [ 95 % CI ] per SD difference : myristic acid 115 [ 95 % CI 109-122 ] , palmitic acid 126 [ 115-137 ] , and stearic acid 106 [ 100-113 ] ) .
RESULTS	By contrast , measured odd-chain SFAs ( 15:0 [ pentadecanoic acid ] and 17:0 [ heptadecanoic acid ] ) were inversely associated with incident type 2 diabetes ( HR [ 95 % CI ] per 1 SD difference : 079 [ 073-085 ] for pentadecanoic acid and 067 [ 063-071 ] for heptadecanoic acid ) , as were measured longer-chain SFAs ( 20:0 [ arachidic acid ] , 22:0 [ behenic acid ] , 23:0 [ tricosanoic acid ] , and 24:0 [ lignoceric acid ] ) , with HRs ranging from 072 to 081 ( 95 % CIs ranging between 061 and 092 ) .
RESULTS	Our findings were robust to a range of sensitivity analyses .
CONCLUSIONS	Different individual plasma phospholipid SFAs were associated with incident type 2 diabetes in opposite directions , which suggests that SFAs are not homogeneous in their effects .
CONCLUSIONS	Our findings emphasise the importance of the recognition of subtypes of these fatty acids .
CONCLUSIONS	An improved understanding of differences in sources of individual SFAs from dietary intake versus endogenous metabolism is needed .
BACKGROUND	EU FP6 programme , Medical Research Council Epidemiology Unit , Medical Research Council Human Nutrition Research , and Cambridge Lipidomics Biomarker Research Initiative .

###24368437
BACKGROUND	Association studies have suggested that lower circulating 25-hydroxyvitamin D [ 25 ( OH ) D ] in African Americans may partially underlie higher rates of cardiovascular disease and cancer in this population .
BACKGROUND	Nonetheless , the relation between vitamin D supplementation and 25 ( OH ) D concentrations in African Americans remains undefined .
OBJECTIVE	Our primary objective was to determine the dose-response relation between vitamin D and plasma 25 ( OH ) D.
METHODS	A total of 328 African Americans in Boston , MA , were enrolled over 3 winters from 2007 to 2010 and randomly assigned to receive a placebo or 1000 , 2000 , or 4000 IU vitamin D/d for 3 mo. .
METHODS	Subjects completed sociodemographic and dietary questionnaires , and plasma samples were drawn at baseline and 3 and 6 mo. .
RESULTS	Median plasma 25 ( OH ) D concentrations at baseline were 15.1 , 16.2 , 13.9 , and 15.7 ng/mL for subjects randomly assigned to receive the placebo or 1000 , 2000 , or 4000 IU/d , respectively ( P = 0.63 ) .
RESULTS	The median plasma 25 ( OH ) D concentration at 3 mo differed significantly between supplementation arms at 13.7 , 29.7 , 34.8 , and 45.9 ng/mL , respectively ( P < 0.001 ) .
RESULTS	An estimated 1640 IU vitamin D/d was needed to raise the plasma 25 ( OH ) D concentration to 20 ng/mL in 97.5 % of participants , whereas a dose of 4000 IU/d was needed to achieve concentrations 33 ng/mL in 80 % of subjects .
RESULTS	No significant hypercalcemia was seen in a subset of participants .
CONCLUSIONS	Within African Americans , an estimated 1640 IU vitamin D/d was required to achieve concentrations of plasma 25 ( OH ) D recommended by the Institute of Medicine , whereas 4000 IU/d was needed to reach concentrations predicted to reduce cancer and cardiovascular disease risk in prospective observational studies .
CONCLUSIONS	These results may be helpful for informing future trials of disease prevention .

###24669314
OBJECTIVE	The purpose of this study was to assess the effect of high intensity interval training ( HIIT ) versus continuous aerobic exercise training ( CONT ) or placebo ( PLA ) on body composition by randomized controlled design .
METHODS	Work capacity and body composition ( dual-energy X-ray absorptiometry ) were measured before and after 12 weeks of intervention in 38 previously inactive overweight adults .
RESULTS	There was a significant group time interaction for change in work capacity ( P < 0.001 ) , which increased significantly in CONT ( 23.8 3.0 % ) and HIIT ( 22.3 3.5 % ) but not PLA ( 3.1 5.0 % ) .
RESULTS	There was a near-significant main effect for percentage trunk fat , with trunk fat reducing in CONT by 3.1 1.6 % and in PLA by 1.1 0.4 % , but not in HIIT ( increase of 0.7 1.0 % ) ( P = 0.07 ) .
RESULTS	There was a significant reduction in android fat percentage in CONT ( 2.7 1.3 % ) and PLA ( 1.4 0.8 % ) but not HIIT ( increase of 0.8 0.7 % ) ( P = 0.04 ) .
CONCLUSIONS	These data suggest that HIIT may be advocated as a time-efficient strategy for eliciting comparable fitness benefits to traditional continuous exercise in inactive , overweight adults .
CONCLUSIONS	However , in this population HIIT does not confer the same benefit to body fat levels as continuous exercise training .

###24656555
OBJECTIVE	To evaluate feasibility , acceptability , continuation , and trough serum levels following self-administration of subcutaneous ( sc ) depot medroxyprogesterone acetate ( DMPA ) .
METHODS	Women presenting to a family planning clinic to initiate , restart or continue DMPA were offered study entry .
METHODS	Participants were randomized in a 2:1 ratio to self - or clinician administered sc DMPA 104 mg .
METHODS	Those randomized to self-administration were taught to self-inject and were supervised in performing the initial injection ; they received printed instructions and a supply of contraceptive injections for home use .
METHODS	Participants randomized to clinician administration received usual care .
METHODS	Continued DMPA use was assessed by self-report and trough medroxyprogesterone acetate levels at 6 and 12 months .
RESULTS	Two hundred fifty women were invited to participate , and 137 ( 55 % ) enrolled .
RESULTS	Of these , 91 were allocated to self-administration , and 90/91 were able to correctly self-administer sc DMPA .
RESULTS	Eighty-seven percent completed follow-up .
RESULTS	DMPA use at 1 year was 71 % for the self-administration group and 63 % for the clinic group ( p = 0.47 ) .
RESULTS	Uninterrupted DMPA use was 47 % and 48 % for the self and clinic administration groups at 1 year ( p = 0.70 ) , respectively .
RESULTS	Serum analyses confirmed similar mean DMPA levels in both groups and therapeutic trough levels in all participants .
CONCLUSIONS	Sixty-three percent of women approached were interested in trying self-administration of DMPA , even in the context of a randomized trial , and nearly all eligible for enrollment were successful at doing so .
CONCLUSIONS	Self-administration and clinic administration resulted in similar continuation rates and similar DMPA serum levels .
CONCLUSIONS	Self-administration of sc DMPA is feasible and may be an attractive alternative for many women .
CONCLUSIONS	Self-administration of sc DMPA is a feasible and attractive option for many women .
CONCLUSIONS	Benefits include increased control over contraceptive measures and less time spent on contracepting behaviors .
CONCLUSIONS	Globally , self-administration has the potential to revolutionize contraceptive uptake by increasing the number of women with access to DMPA .

###25335648
BACKGROUND	Heavy drinking smokers ( HDS ) have more difficulty quitting smoking than lighter drinkers or abstainers .
BACKGROUND	The opioid antagonist naltrexone may improve smoking quit rates and reduce alcohol use in drinker-smokers , but its relative efficacy in smokers with a range of drinking patterns is unknown .
BACKGROUND	The current study tested the hypothesis that HDS would show differential benefit of naltrexone versus placebo relative to moderate-to-light or nondrinking smokers in terms of improving smoking outcomes and reducing alcohol consumption .
METHODS	Adult smokers ( N = 315 ) enrolled in a 12-week , double-blinded , placebo-controlled trial of 50mg naltrexone for smoking cessation were categorized into subgroups based upon past 6-month drinking patterns : HDS ( n = 69 ; i.e. , averaged 2 heavy drinking episodes per month ) , moderate-to-light drinking smokers ( n = 204 , i.e. , consumed 1 drink up to a maximum of < 2 heavy drinking episodes per month on average ) , or nondrinking smokers ( n = 42 , no alcohol consumed in the past 6months ) .
METHODS	The groups were compared on the main study outcomes of biochemically verified prolonged abstinence quit rates ( i.e. , no smoking weeks 2 to 12 ) , and smoking urge and alcohol use ( drinks/wk ) during treatment .
RESULTS	Naltrexone significantly increased 12-week smoking abstinence rates and decreased smoking urge and alcohol use among HDS , but not moderate-to-light or nondrinking smokers .
RESULTS	Mediation analyses in HDS revealed that naltrexone 's effect on smoking urge during the first 4weeks of treatment mediated its effect on quit rates .
CONCLUSIONS	HDS appear to be particularly sensitive to naltrexone effects on smoking and drinking outcomes .
CONCLUSIONS	This group may represent an important target for adjunctive treatment with naltrexone to optimize smoking cessation outcomes .

###24636627
OBJECTIVE	To examine the association between health status , diabetes-specific quality of life ( QoL ) and glycaemic control among individuals with type 2 diabetes .
METHODS	1876 individuals with screen-detected diabetes and a mean age of 66 years underwent assessment of self-reported health status ( SF-36 ) , diabetes-specific QoL ( the Audit of Diabetes Dependent Quality of Life ( ADDQoL19 ) ) and glycated haemoglobin ( HbA1c ) at five years post-diagnosis in the ADDITION-Europe trial .
METHODS	Multivariable linear regression was used to quantify the cross-sectional association between health status , diabetes-specific QoL and HbA1c , adjusting for age , sex , education , alcohol consumption , physical activity , BMI , intake of any glucose-lowering drugs , and trial arm .
RESULTS	The mean ( SD ) SF-36 physical and mental health summary scores were 46.2 ( 10.4 ) and 54.6 ( 8.6 ) , respectively .
RESULTS	The median average weighted impact ADDQoL score was -0.32 ( IQR -0.89 to -0.06 ) , indicating an overall negative impact of diabetes on QoL .
RESULTS	Individuals who reported a negative impact of diabetes on their QoL had higher HbA1c levels at five years after diagnosis compared with those who reported a positive or no impact of diabetes ( b-coefficient [ 95 % CI ] : b = 0.2 [ 0.1 , 0.3 ] ) .
RESULTS	Physical and mental health summary SF-36 scores were not significantly associated with HbA1c in multivariable analysis .
CONCLUSIONS	Diabetes-specific QoL but not health status was independently associated with HbA1c .
CONCLUSIONS	Practitioners should take account of the complex relationship between diabetes-specific QoL and glucose , particularly with regard to dietary behaviour .
CONCLUSIONS	Future research should attempt to elucidate via which pathways this association might act .

###25920302
BACKGROUND	This study aims to preliminarily evaluate effect on physical properties of shoulder joints and cognitive function after practicing Rue-si-dad-ton , a Thai traditional exercise using the postures of the hermit doing body contortion which still lacks systematically conducted evidence-based regarding its benefits .
METHODS	Thirty-seven participants who have routinely worked on computer at least 3 hours per day were recruited and randomized into intervention ( n = 19 ) or control group ( n = 18 ) .
METHODS	Physical effect on shoulder joints was evaluated by measuring shoulder range of motion ( ROM ) and evaluating shoulder function with the American Shoulder & Elbow Surgeons Standardized Shoulder Assessment Form .
METHODS	Cognitive function was determined by Verbal Fluency Test , Trail Maker B Test , and Digit Span Test .
METHODS	Both study groups were assessed by all tests at the beginning and at the end of study by blinded assessors .
METHODS	The intervention group performed 3 postures of Rue-si-dad-ton exercise ( an hour per day for 4 days by a well-trained instructor ) before thefinal measurement .
RESULTS	Only left and right shoulder flexion of the intervention group ( p-value = 0.006 and 0.010 respectively ) showed significant increment compared with the control group using ANCOVA test with baseline adjusted as covariate .
RESULTS	Other variables , including joint and cognitive function , indicated no significant changes between groups .
RESULTS	No complications from exercise were found during the study
CONCLUSIONS	Rue-si-dad-ton may safely help improve range of joint motion with potential benefit for joint and cognitive function .
CONCLUSIONS	Additional extensive studies with adequate number of participants and longer period of exercise are warranted .

###24351063
BACKGROUND	Recruiting participants to multicentre , community-based trials is a challenge .
BACKGROUND	This case study describes how this challenge was met for the BeWEL trial , which evaluated the impact of a diet and physical activity intervention on body weight in people who had had pre-cancerous bowel polyps .
METHODS	The BeWEL trial was a community-based trial , involving centres linked to the Scottish National Health Service ( NHS ) colorectal cancer screening programme .
METHODS	BeWEL had a recruitment target of 316 and its primary recruitment route was the colonoscopy clinics of the Scottish Bowel Screening Programme .
RESULTS	BeWEL exceeded its recruitment target but needed a 6-month no-cost extension from the funder to achieve this .
RESULTS	The major causes of delay were lower consent rates ( 49 % as opposed to 70 % estimated from earlier work ) , the time taken for NHS research and development department approvals and the inclusion of two additional sites to increase recruitment , for which there were substantial bureaucratic delays .
RESULTS	A range of specific interventions to increase recruitment , for example , telephone reminders and a shorter participant information leaflet , helped to increase the proportion of eligible individuals consenting and being randomized .
CONCLUSIONS	Recruitment to multicentre trials is a challenge but can be successfully achieved with a committed team .
CONCLUSIONS	In a UK context , NHS research and development approval can be a substantial source of delay .
CONCLUSIONS	Investigators should be cautious when estimating consent rates .
CONCLUSIONS	If consent rates are less than expected , qualitative analysis might be beneficial , to try and identify the reason .
CONCLUSIONS	Finally , investigators should select trial sites on the basis of a formal assessment of a site 's past performance and the likelihood of success in the trial being planned .
BACKGROUND	Current Controlled Trials ISRCTN53033856 .

###25327942
OBJECTIVE	To evaluate safety and haematological effects of delayed cord clamping ( DCC ) in infants with expected low birthweight born in a resource-poor setting .
METHODS	Randomised controlled trial involving pregnant women in early labour 18 years with intrapartum symphysal-fundal height 32 cm .
METHODS	Mothers were randomised for either early cord clamping ( ECC , < 30 s ) or DCC ( 2-3 min after birth ) .
RESULTS	We included 104 vigorous infants born by vaginal delivery , of whom 39 % had a birthweight < 2500 g. Infant haemoglobin ( Hb ) levels 24 h after birth were significantly higher in the DCC group ( 18.0 g/dl vs. 16.8 g/dl , P = 0.006 ) .
RESULTS	Despite successful placental transfusion , hyperbilirubinemia and hyperviscosity were not observed .
RESULTS	Two months after birth , there were no differences in Hb between groups ( 9.9 g/dl vs. 9.8 g/dl , P = 0.60 ) , but the infants in the DCC group had better weight gain from baseline than those with ECC ( 2.2 kg vs. 1.9 kg , P = 0.058 ) .
CONCLUSIONS	In this South African cohort of newborns with a subnormal distribution of birthweight delayed cord clamping was a safe procedure .
CONCLUSIONS	Two months after birth the effect of DCC on Hb was not detectable anymore .
CONCLUSIONS	DCC should be promoted in every singleton delivery in a resource-poor setting irrespective of the birthweight .

###25129884
OBJECTIVE	Sleep disorders are common among patients hospitalized in coronary care unit ( CCU ) .
OBJECTIVE	This study aimed to investigate the effect of Rosa damascene aromatherapy on sleep quality of patients hospitalized in CCU .
METHODS	In this randomized controlled trial , 60 patients who met the inclusion criteria were conveniently sampled and randomly allocated to the experimental and control groups .
METHODS	Patients in the control group received routine care .
METHODS	In the experimental group , patients received routine care and Rosa damascene aromatherapy for three subsequent nights .
METHODS	In the both groups the sleep quality was assessed using the Pittsburgh Sleep Quality Index .
RESULTS	After the study , the mean scores of five domains of Pittsburg Sleep Quality Index as well as the mean of total score of the index in the experimental group were significantly lower than the control group .
CONCLUSIONS	Rosa damascene aromatherapy can significantly improve the sleep quality of patients hospitalized in CCUs .

###24445534
OBJECTIVE	We evaluated whether self-monitoring of blood glucose ( SMBG ) leads to better glycaemic control ( HbA ( 1c ) ) in patients with type 2 diabetes on conventional insulin regimens .
METHODS	Patients with type 2 diabetes on a conventional insulin regimen ( basal or premixed insulin with or without additional oral glucose-lowering agents ) were recruited at study centres led by members of the German Diabetes Association .
METHODS	In a randomised , prospective , open 22 factorial design , the once-weekly performance of four-point glucose profiles ( SMBG + ; n = 151 patients ) was compared with no SMBG ( SMBG - ; n = 149 ) , and the measuring and transmitting of HbA1c results to the study centres ( HbA ( 1c ) + ; n = 158 , of these 82 SMBG - and 76 SMBG + ) was compared with HbA1c measurement without disclosure of results ( HbA ( 1c ) - ; n = 142 , of these 67 SMBG - and 75 SMBG + ) .
METHODS	Randomised allocation was carried out by a central office , using sequentially numbered , sealed envelopes .
METHODS	The primary endpoint was the reduction of HbA ( 1c ) compared with baseline after 12 months .
METHODS	Secondary analyses were of therapy intensification in response to higher blood or urinary glucose or HbA ( 1c ) .
METHODS	Participants and caregivers were not blinded as to the allocation of interventions , whereas the laboratory determining HbA ( 1c ) remained blinded .
RESULTS	Patient characteristics were balanced across groups .
RESULTS	A total of 56 patients dropped out .
RESULTS	In completers , HbA ( 1c ) was reduced in the SMBG + group from 7.3 % to 7.0 % , i.e. by 0.3 % ( 0.1 % , 0.5 % ) vs SMBG - from 7.3 % to 7.0 % and 0.3 % ( 0.2 % , 0.5 % ) , respectively , the difference being 0.0 % ( -0.2 % , 0.2 % ) ( p = 0.93 ) .
RESULTS	The disclosure of HbA ( 1c ) results had no significant influence , with a difference of 0.1 % ( -0.1 % , 0.4 % ) ( p = 0.28 ) .
RESULTS	Values above are mean ( 95 % CI ) .
RESULTS	The ORs for therapy intensification significantly rose as the following increased : proportions of urine samples testing positive for glucose , HbA1c concentrations , and fasting or postprandial glucose concentrations .
RESULTS	No important adverse events were associated with the interventions .
CONCLUSIONS	SMBG profiles once weekly or the disclosure of HbA ( 1c ) results did not improve glycaemic control in patients with type 2 diabetes on conventional insulin treatment , although indicators of hyperglycaemia increased the likelihood of therapy intensification .
CONCLUSIONS	Greater intensification may be necessary to impact on glycaemic control .
BACKGROUND	www.clinicaltrials.gov ( registration code NCT00688363 ) FUNDING : Deutsche Diabetes-Gesellschaft , Deutsche Diabetes-Stiftung , Bayer Vital GmbH .

###26398070
BACKGROUND	Three anatomical sites are commonly used to insert central venous catheters , but insertion at each site has the potential for major complications .
METHODS	In this multicenter trial , we randomly assigned nontunneled central venous catheterization in patients in the adult intensive care unit ( ICU ) to the subclavian , jugular , or femoral vein ( in a 1:1:1 ratio if all three insertion sites were suitable [ three-choice scheme ] and in a 1:1 ratio if two sites were suitable [ two-choice scheme ] ) .
METHODS	The primary outcome measure was a composite of catheter-related bloodstream infection and symptomatic deep-vein thrombosis .
RESULTS	A total of 3471 catheters were inserted in 3027 patients .
RESULTS	In the three-choice comparison , there were 8 , 20 , and 22 primary outcome events in the subclavian , jugular , and femoral groups , respectively ( 1.5 , 3.6 , and 4.6 per 1000 catheter-days ; P = 0.02 ) .
RESULTS	In pairwise comparisons , the risk of the primary outcome was significantly higher in the femoral group than in the subclavian group ( hazard ratio , 3.5 ; 95 % confidence interval [ CI ] , 1.5 to 7.8 ; P = 0.003 ) and in the jugular group than in the subclavian group ( hazard ratio , 2.1 ; 95 % CI , 1.0 to 4.3 ; P = 0.04 ) , whereas the risk in the femoral group was similar to that in the jugular group ( hazard ratio , 1.3 ; 95 % CI , 0.8 to 2.1 ; P = 0.30 ) .
RESULTS	In the three-choice comparison , pneumothorax requiring chest-tube insertion occurred in association with 13 ( 1.5 % ) of the subclavian-vein insertions and 4 ( 0.5 % ) of the jugular-vein insertions .
CONCLUSIONS	In this trial , subclavian-vein catheterization was associated with a lower risk of bloodstream infection and symptomatic thrombosis and a higher risk of pneumothorax than jugular-vein or femoral-vein catheterization .
CONCLUSIONS	( Funded by the Hospital Program for Clinical Research , French Ministry of Health ; ClinicalTrials.gov number , NCT01479153 . )

###25257294
BACKGROUND	This research used context aware experiential sampling to investigate the effect of contexts on in vivo alcohol-related outcome expectancies .
METHODS	A time-stratified random sampling strategy was adopted to assess 72 students and young professionals at 5 daily intervals over the course of a week using a specifically designed smartphone application .
METHODS	This application recorded respondents ' present situational and social contexts , alcohol consumption , and alcohol-related cognitions in real-time .
RESULTS	In vivo social and environmental contexts and current alcohol consumption accounted for a significant proportion of variance in outcome expectancies .
RESULTS	For instance , prompts which occurred while participants were situated in a pub , bar , or club and in a social group of friends were associated with heightened outcome expectancies in comparison with other settings .
CONCLUSIONS	Alcohol-related expectancies do not appear to be static but instead demonstrate variation across social and environmental contexts .
CONCLUSIONS	Modern technology can be usefully employed to provide a more ecologically valid means of measuring such beliefs .

###24268189
BACKGROUND	Intramedullary techniques for stabilization of displaced distal radius fractures are now available .
BACKGROUND	Purported benefits include limited soft tissue dissection while affording sufficient stability to allow early wrist motion .
BACKGROUND	The primary null hypothesis of this randomized trial is that there is no significant difference with respect to functional outcome , pain and disability between patients treated with either 2.4-mm volar locking plate fixation or intramedullary nail fixation of unstable dorsally displaced extra-articular fractures of the distal radius .
METHODS	We conducted a single-centre , parallel-group trial , with unrestricted randomization .
METHODS	Patients with dorsally displaced extra-articular distal radius fractures were randomized to receive volar locking plate ( n = 72 ) fixation or intramedullary nailing ( n = 80 ) .
METHODS	The outcome was measured on the basis of the Gartland and Werley and Castaing score ; the pain level ; the range of wrist motion ; the rate of complications ; and radiographic measurements including volar tilt and ulnar variance .
METHODS	Clinical and radiographic assessment was performed at 8 weeks , 6 months , 1 year and 2 years after the operation .
RESULTS	There were no significant differences between groups in terms of range of motion , grip strength or the level of pain during the entire follow-up period ( p > 0.05 ) .
RESULTS	There was no significant difference between treatment groups with respect to volar tilt or ulnar variance ( p > 0.05 ) .
RESULTS	There was no significant difference in the complication rate between groups ( p > 0.05 ) .
CONCLUSIONS	The present study supports the view that intramedullary nail fixation and volar plate fixation for the treatment of displaced extra-articular distal radius fractures have equivalent radiographic and functional outcomes .
METHODS	Level I therapeutic study .

###25296247
BACKGROUND	Emergence hypertension after craniotomy is a well-documented phenomenon for which natural history is poorly understood .
BACKGROUND	Most clinicians attribute this phenomenon to an acute and transient increase in catecholamine release , but other mechanisms such as neurogenic hypertension or activation of the renin-angiotensin-aldosterone system have also been proposed .
BACKGROUND	In this open-label study , we compared the monotherapeutic antihypertensive efficacy of the 2 most titratable drugs used to treat postcraniotomy emergence hypertension : nicardipine and esmolol .
BACKGROUND	We also investigated the effect of preoperative hypertension on postcraniotomy hypertension and the natural history of postcraniotomy hypertension in the early postoperative period .
METHODS	Fifty-two subjects were prospectively randomized to receive either nicardipine or esmolol as the sole drug for treatment of emergence hypertension at the conclusion of brain tumor resection ( 40 subjects finally analyzed ) .
METHODS	After a uniform anesthetic , standardized protocols of these antihypertensive medications were administered for the treatment of systolic blood pressure ( SBP ) > 130 , with the goal of maintaining SBP < 140 throughout the first postoperative day .
METHODS	In the event of study medication `` failure , '' a `` rescue '' antihypertensive ( labetalol or hydralazine ) was used .
METHODS	The O'Brien-Fleming Spending Function was used to calculate the appropriate value for each interim analysis of the primary outcome ; univariate analysis was performed otherwise , with a 2-sided P < 0.05 considered statistically significant .
RESULTS	The incidence of nicardipine failure ( 5 % , 95 % confidence interval [ CI ] 0.1 % -24.9 % ) was significantly less than that of esmolol ( 55 % , 95 % CI 31.5 % -76.9 % ) as a sole drug in controlling SBP after brain tumor resection ( difference 99 % CI 13.8 % -75.7 % , P = 0.0012 ) .
RESULTS	The presence of preoperative hypertension or the approach to surgery ( open craniotomy versus endonasal transsphenoidal ) had no significant effect on the incidence of failure of the antihypertensive regimen used .
RESULTS	We did not observe a difference in the need for opioid therapy for postcraniotomy pain between drug groups ( 99 % CI difference -39.2 % -30.2 % ) .
RESULTS	Failure of the study drug predicted the need for rescue drug therapy in the initial 12 hours after discharge from the recovery room ( difference success versus failure = -41.7 % , 99 % CI difference -72.3 % to -1.8 % , P = 0.0336 ) but not during the period 12 to 24 hours after discharge from the recovery room ( difference success versus failure = -27.4 % , 99 % CI difference -63.8 % -9.2 % , P = 0.143 ) .
RESULTS	However , in those patients carrying a preoperative diagnosis of hypertension , the need for rescue medication was only different during the period 12 to 24 hours after discharge from the recovery room ( difference normotensive versus hypertensive = -35.4 % , 99 % CI difference -66.9 % to -0.3 % , P = 0.0254 ) .
CONCLUSIONS	Nicardipine is superior to esmolol for the treatment of postcraniotomy emergence hypertension .
CONCLUSIONS	This type of hypertension is thought to be a transient phenomenon not solely related to sympathetic activation and catecholamine surge but also possibly encompassing other physiologic factors .
CONCLUSIONS	For treating postcraniotomy emergence hypertension , nicardipine is a relatively effective sole drug , whereas if esmolol is used , rescue antihypertensive medications should be readily available .

###25565364
OBJECTIVE	To investigate whether a fixed-dose combination ( FDC ) of 0.5 mg dutasteride and 0.4 mg tamsulosin is more effective than watchful waiting with protocol-defined initiation of tamsulosin therapy if symptoms did not improve ( WW-All ) in treatment-nave men with moderately symptomatic benign prostatic hyperplasia ( BPH ) at risk of progression .
METHODS	This was a multicentre , randomised , open-label , parallel-group study ( NCT01294592 ) in 742 men with an International Prostate Symptom Score ( IPSS ) of 8-19 , prostate volume 30mL and total serum PSA level of 1.5 ng/mL .
METHODS	Patients were randomised to FDC ( 369 patients ) or WW-All ( 373 ) and followed for 24 months .
METHODS	All patients were given lifestyle advice .
METHODS	The primary endpoint was symptomatic improvement from baseline to 24 months , measured by the IPSS .
METHODS	Secondary outcomes included BPH clinical progression , impact on quality of life ( QoL ) , and safety .
RESULTS	The change in IPSS at 24 months was significantly greater for FDC than WW-All ( -5.4 vs -3.6 points , P < 0.001 ) .
RESULTS	With FDC , the risk of BPH progression was reduced by 43.1 % ( P < 0.001 ) ; 29 % and 18 % of men in the WW-All and FDC groups had clinical progression , respectively , comprising symptomatic progression in most patients .
RESULTS	Improvements in QoL ( BPH Impact Index and question 8 of the IPSS ) were seen in both groups but were significantly greater with FDC ( P < 0.001 ) .
RESULTS	The safety profile of FDC was consistent with established profiles of dutasteride and tamsulosin .
CONCLUSIONS	FDC therapy with dutasteride and tamsulosin , plus lifestyle advice , resulted in rapid and sustained improvements in men with moderate BPH symptoms at risk of progression with significantly greater symptom and QoL improvements and a significantly reduced risk of BPH progression compared with WW plus initiation of tamsulosin as per protocol .

###24698577
OBJECTIVE	Dynamic hip screw ( DHS ) is recommended for the fixation of stable intertrochanteric fractures .
OBJECTIVE	Its postoperative cut-out rate ranges from 1 % to 6 % .
OBJECTIVE	In osteoporotic bone , normal screws in DHS blade provide less anchorage compared to locking screws .
OBJECTIVE	This study aims to compare DHS with locking side plate and conventional side plate .
METHODS	Fifty consecutive patients with intertrochanteric fractures were randomly allocated for fixation with a standard DHS ( group A ) and locking DHS ( Combi plate , group B ) .
METHODS	We compared the clinical and radiological outcomes for the conventional DHS and locking DHS in intertrochanteric fractures .
METHODS	Functional outcome was evaluated using the Parker mobility score .
RESULTS	Coxa valga was found more frequently in group A than in group B ( 12 % vs. 0 % , P = 0.42 ) .
RESULTS	Coxa vara showed the same trend ( 12 % vs. 8 % , P = 0.81 ) .
RESULTS	Rate of restoration of postoperative neck-shaft angle within 20 of sound side was higher in group B ( 8 % cases ) than in group A ( 4 % cases , P = 0.98 ) .
RESULTS	The rate of anteversion angle restoration within 10 of sound side was also higher in group B ( 100 % vs. 88 % , P = 0.85 ) .
RESULTS	The average lag screw slippage in group A and group B was 3.2 mm and 4.2 mm , the average fracture union duration was 17.1 weeks and 16.4 weeks , and the mean Parker score was 5.6 and 5.8 respectively .
RESULTS	Screw cut-out was seen in one patient in group A. No cut-out was seen in any of the patient in group B. No patient developed deep infection , avascular necrosis , deep vein thrombosis or any other significant complications .
CONCLUSIONS	The present study demonstrated that treating intertrochanteric fracture with a locking DHS allows sound bone healing and is not associated with any major complications .
CONCLUSIONS	Although this report is promising , it should be interpreted with caution because only a prospective study with a large sample size would allow definitive conclusion .

###25335446
OBJECTIVE	Studies evaluating the effect of folic acid supplementation , either alone or in combination with iron , on the linear and ponderal growth of children are practically nonexistent .
OBJECTIVE	The aim of this study was to assess the effect of folic acid supplementation with ferrous sulfate on both linear growth and weight gain in anemic and nonanemic children attending Municipal Daycare Centers in Goiania , State of Goias , Brazil .
METHODS	A double-blind , randomized , controlled trial was conducted on 188 children aged 6-24 months .
METHODS	The effects of ferrous sulfate and folic acid supplementation were evaluated using the analysis of variance procedure , based on a double factorial model with two factors of fixed effects ( folic acid supplementation and ferrous sulfate supplementation ) , adjusted for initial weight .
METHODS	The level of significance was 0.05 .
RESULTS	The children who received folic acid supplementation showed greater weight gain than the monthly average weight gain of those not given the supplement ( P = 0.026 ) .
RESULTS	This effect was independent of the dose of ferrous sulfate ( P for interaction = 0.693 ) .
RESULTS	Folic acid supplementation increased the gain of weight-for-age Z-score when compared with the placebo group ( P = 0.018 ) , independent of the dose of ferrous sulfate .
CONCLUSIONS	Folic acid had no effect on linear growth .
CONCLUSIONS	The use of folic acid supplementation increased the monthly average weight gain and the gain in weight-for-age Z-score compared with the placebo group .
CONCLUSIONS	This effect was independent of the dose of ferrous sulfate .

###24571341
OBJECTIVE	To determine if differing gauge ( G ) needles used for venipuncture altered the automated platelet count and coagulation profile ( prothrombin time ( PT ) and activated partial thromboplastin time ( aPTT ) ) in clinically healthy dogs .
METHODS	Prospective , observational , randomised , clinical study .
METHODS	We enrolled 20 clinically healthy dogs .
METHODS	Blood was collected via direct venipuncture of the jugular veins with 21G , 23G and 25G needles in a random order .
METHODS	Automated haematology and automated coagulation times were performed on the blood samples .
METHODS	Values were analysed for differences among the needle gauges and also the order of sample collection .
RESULTS	No difference was found in the automated platelet count or automated coagulation times for the three needle gauges used or the order in which the samples were collected .
CONCLUSIONS	Venipuncture can be performed with a 21G , 23G or 25G needle to obtain blood from dogs for automated platelet count and PT/aPTT measurement without affecting the results .

###24262513
OBJECTIVE	Dried fruits , like their fresh homologues , contain relatively high concentrations of antioxidants .
OBJECTIVE	The aim of this study was to determine the health outcomes of raisin consumption on patients with diabetes .
METHODS	We examined the effects of dried grapes ( Vitis vinifera ) cultivated in Greece , namely Corinthian Raisins ( CR ) on blood pressure , fasting glucose , glucated hemoglobin ( HbA1c ) , lipid peroxidation , high-sensitivity C-reactive protein , antioxidant status , and cytokines in patients with type 2 diabetes mellitus ( T2DM ) .
METHODS	Forty-eight well-controlled patients with T2DM from the diabetes outpatient clinic of our hospital were recruited to a two-armed , randomized , controlled , 24-wk prospective intervention trial in order to examine the health outcomes of CR consumption .
METHODS	All participants were reported to consume less fruits and vegetables than the recommended amount of five servings daily .
METHODS	Participants in the intervention were instructed to consume CR equal to two fruit servings ( 36 g/d ) , replacing snacks with similar energy density twice during the day .
METHODS	Anthropometric and blood pressure measurements , assessment of dietary intake , and fasting blood draws were conducted at baseline and at week 24 .
METHODS	Also , phenolic compounds present in CR were analyzed in plasma of the patients .
METHODS	t Test for parametric data and Mann-Whitney test or Wilcoxon test for non-parametric data were performed .
METHODS	Significance was set at P < 0.05 .
RESULTS	Body weight , glycemic control , and lipid profile were not affected in either arm .
RESULTS	Patients in the CR arm reduced their diastolic blood pressure and increased their total antioxidant potential significantly compared with baseline .
RESULTS	The differences between the two groups at week 24 were significant .
RESULTS	No change in high-sensitivity C-reactive protein was observed .
RESULTS	A significant difference in plasma circulating p-hydroxybenzoic acid was observed between groups at the end of the trial .
CONCLUSIONS	Our study shows that naturally CR may improve health features in patients with well-controlled T2DM .

###25607509
BACKGROUND	The use of low-dose aspirin ( LDA ) has emerged as an important cause of gastrointestinal ulcers .
BACKGROUND	The aim of this study was to investigate the association between LDA-induced gastric mucosal injury and the expression of vascular endothelial growth factor ( VEGF ) and cell apoptosis in elderly Chinese patients .
METHODS	A total of 136 patients aged 60 to 80 years with LDA-induced ( 100 mg/d for at least 1 month ) gastric mucosal injury and 48 age-matched healthy subjects were enrolled in this study .
METHODS	The patients were divided into a low-severity group and a high-severity group based on their modified Lanza scale scores .
METHODS	Biopsy specimens of gastric mucosa from all participants were subjected to immunohistochemical staining for VEGF expression and terminal deoxynucleotidyl transferase dUTP nick end labeling staining for cell apoptosis .
METHODS	Staining indices and apoptotic indices were applied to assess VEGF expression level and the extent of cell apoptosis .
RESULTS	VEGF expression decreased significantly in the 2 patient groups , whereas the extent of cell apoptosis significantly increased compared with the control group .
RESULTS	Furthermore , Spearman 's correlation coefficients suggest that VEGF expression levels and the extent of cell apoptosis in gastric mucosae shared a significant correlation with the severity of LDA-induced gastric mucosal injury .
RESULTS	Receiver operating characteristics analysis further confirmed these results .
CONCLUSIONS	Our findings provide important clues as to the underlying molecular mechanism behind gastric mucosal injury resulting from exposure to LDA in elderly adults , and also suggest that interventions specifically targeting the pathways associated with angiogenesis and apoptosis may help facilitate the healing process .

###24742314
BACKGROUND	Despite the improvement in the care management , women cancer patients who are still in employment find themselves for the most part obliged to stop working while they are having treatment .
BACKGROUND	Their return-to-work probability is impacted by numerous psychosocial factors .
BACKGROUND	The objective is to describe the development and the content of an intervention aimed to facilitate the return to work of female breast cancer patients and in particular the women in the most precarious situations through early active individualised psychosocial support ( APAPI ) .
METHODS	The intervention proposed is made up of 4 interviews with a psychologist at the hospital , distributed over the year according to the diagnosis and conducted on the same day as a conventional follow-up consultation , then a consultation with a specialist job retention physician .
METHODS	We expect , in the first instance , that this intervention will reduce the social inequalities of the return-to-work rate at 12 months .
METHODS	The EPICES score will enable the population to be broken down according to the level of social precariousness .
METHODS	The other expected results are the reduction of the social inequalities in the quality of the return to work at 18 and 24 months and the disparities between the individual and collective resources of the patients .
METHODS	This intervention is assessed in the context of a controlled and randomised multi-centre study .
METHODS	The patients eligible are women aged between 18 and 55 years with a unilateral breast cancer with local extension exclusively , having received surgery followed by adjuvant chemotherapy , in employment at the time of the diagnosis and dealt with by one of the 2 investigating centres .
CONCLUSIONS	It is essential to assess this type of intervention before envisaging its generalisation .
CONCLUSIONS	The study set in place will enable us to measure the impact of this intervention aiming to facilitate the return to work of breast cancer patients , in particular for those who suffer from social fragility , compared with the standard care .

###25144793
BACKGROUND	Infant HIV-1 infection is associated with impaired neurologic and motor development .
BACKGROUND	Antiretroviral therapy ( ART ) has the potential to improve developmental outcomes but the relative contributions of pre-ART disease status , growth , treatment regimen and ART response during infancy are unknown .
METHODS	Kenyan ART-naive infants < 5-months old initiated ART and had monthly assessment of age of full neck control , unsupported walking and monosyllabic speech during 24 months of follow-up .
METHODS	Pre-ART and post-ART correlates of age at milestone attainment were evaluated using t tests or multivariate linear regression .
RESULTS	Among 99 infants , pre-ART correlates of later milestone attainment included : underweight and stunted ( neck control , walking and speech , all P values < 0.05 ) , missed prevention of mother-to-child transmission ( P = 0.04 ) ( neck control ) , previous hospitalization , World Health Organization ( WHO ) Stage III/IV , low CD4 count , and wasting ( speech and walking , all P values < 0.05 ) , and low maternal CD4 ( speech , P = 0.04 ) .
RESULTS	Infants initiated ART at a median of 14 days following enrollment .
RESULTS	Infants receiving lopinavir/ritonavir-based versus nevirapine-based ART attained later speech ( 18.1 vs. 15.5 months , P = 0.003 ) .
RESULTS	Adjusting for pre-ART level , lower 6-month gain in CD4 % was associated with later walking ( 0.18 months earlier per unit increase in CD4 % ; P = 0.004 ) and speech ( 0.12 months earlier per unit increase in CD4 % ; P = 0.05 ) , and lower 6-month gains in weight-for-age ( P = 0.009 ) , height-for-age ( P = 0.03 ) and weight-for-height ( P = 0.02 ) were associated with later walking .
CONCLUSIONS	In HIV-infected infants , compromised pre-ART immune and growth status , poor post-ART immune and growth responses , and use of lopinavir/ritonavir-based versus nevirapine-based ART were each associated with later milestone attainment .
CONCLUSIONS	The long-term consequences of these delays are unknown .

###24635053
OBJECTIVE	To determine whether symptoms and clinical signs of swallowing dysfunction could be easily identified in community-dwelling elderly adults and to examine the association between self-report and direct observation of symptoms and signs of swallowing dysfunction .
METHODS	Physiological substudy conducted as a home visit within an observational cohort study .
METHODS	Baltimore City and County , Maryland .
METHODS	Community-dwelling elderly women without history of dysphagia or neurological disease aged 85 to 94 enrolled in the Women 's Health and Aging Study II ( N = 47 ) .
METHODS	Three trials of the 3-ounce water swallowing test , swallowing function questionnaire , and frailty status .
RESULTS	Thirty-four ( 72 % ) subjects demonstrated swallowing dysfunction in at least one swallowing trial and 16 ( 34 % ) in all three trials .
RESULTS	The most common signs of dysfunction were throat clear and wet voice .
RESULTS	Conversely , participants reported few symptoms of dysphagia on a swallowing function questionnaire .
RESULTS	The most common symptom , reported by approximately 15 % of participants , was the sensation of the food going `` down the wrong way , '' 8.5 % or fewer participants reported other symptoms .
CONCLUSIONS	Signs of swallowing dysfunction were present in a large majority of community-dwelling old-old women , but they were largely unrecognized and reported .
CONCLUSIONS	Formal evaluation of swallowing function in community-dwelling elderly adults is necessary to determine the clinical consequences of these findings .

###24571700
OBJECTIVE	To assess the ability of various fluoride salts to protect enamel against acid attack via a barrier mechanism .
METHODS	Extracted human enamel specimens were cleaned and rinsed , then soaked in pooled human saliva for 1 hour to initiate formation of an early pellicle .
METHODS	Groups of three specimens each were etched for 10 minutes in 1 % citric acid ( pH 2.3 ) , treated in a 1:3 slurry of dentifrice [ 1,100 ppm F as stannous fluoride ( SnF2 ) , 1,100 ppm F as sodium fluoride ( NaF ) , 1,000 ppm F as sodium monofluorophosphate ( SMFP ) , or 1,400 ppm F as amine fluoride ( AmF ) ] and saliva for 2 minutes , exposed to 2 % alizarin red-S ( a calcium-selective dye ) and rinsed again .
METHODS	The relative ability of each test product to deposit a barrier layer on the enamel surface was measured by its ability to protect against attachment of the calcium-selective dye .
RESULTS	Specimens treated with the SnF2 dentifrice showed the least dye attachment , indicating a high level of surface protection .
RESULTS	On a five-point scale , with 0 being no dye deposition ( 100 % protection ) and four being complete dye coverage ( 0 % protection ) , the SnF2 - treated specimens scored an average of 0.25 , with NaF scoring 3.4 , SMFP scoring 3.4 and AmF scoring 3.7 .
RESULTS	Protection of the enamel surface was significantly higher for the SnF2 product than for the other products ( P < 0.05 ) , with no significant differences among the other three F salts .
CONCLUSIONS	These results demonstrate that after an aggressive acid challenge , SnF2 deposits a barrier layer onto the pellicle-coated enamel surface , and the barrier layer which attaches onto acid challenged tooth surfaces is different from any that might be provided by treatment with the other fluoride compounds tested .

###26180145
OBJECTIVE	To assess the effectiveness , feasibility , and safety of short-term inspiratory and expiratory muscle training ( IEMT ) in subacute stroke patients .
METHODS	Within 2 weeks of stroke onset , 109 patients with a first ischemic stroke event were randomly assigned to the IEMT ( n = 56 ) or sham IEMT ( n = 53 ) study group .
METHODS	The IEMT consisted of 5 sets of 10 repetitions , twice a day , 5 days per week for 3 weeks , at a training workload equivalent to 30 % of maximal respiratory pressures .
METHODS	Patients and researchers assessing outcome variables were blinded to the assigned study group .
METHODS	The main outcome was respiratory muscle strength assessed by maximal inspiratory and expiratory pressures ( PImax , PEmax ) .
METHODS	Respiratory complications at 6 months were also recorded .
RESULTS	Both groups improved respiratory muscle strength during the study .
RESULTS	IEMT was associated with significantly improved % PImax and % PEmax : effect size d = 0.74 ( 95 % confidence interval [ CI ] 0.28-1 .20 ) and d = 0.56 ( 95 % CI 0.11-1 .02 ) , respectively .
RESULTS	No significant training effect was observed for peripheral muscle strength .
RESULTS	Respiratory complications at 6 months occurred more frequently in the sham group ( 8 vs 2 , p = 0.042 ) , with an absolute risk reduction of 14 % .
RESULTS	The number needed to treat to prevent one lung infection event over a follow-up of 6 months was 7 .
RESULTS	No major adverse events or side effects were observed .
CONCLUSIONS	IEMT induces significant improvement in inspiratory and expiratory muscle strength and could potentially offer an additional therapeutic tool aimed to reduce respiratory complications at 6 months in stroke patients .
METHODS	This study provides Class II evidence that short-term training may have the potential to improve respiratory muscle strength in patients with subacute stroke .

###24256459
BACKGROUND	Unstuck and On Target ( UOT ) is an executive function ( EF ) intervention for children with autism spectrum disorders ( ASD ) targeting insistence on sameness , flexibility , goal-setting , and planning through a cognitive-behavioral program of self-regulatory scripts , guided/faded practice , and visual/verbal cueing .
BACKGROUND	UOT is contextually-based because it is implemented in school and at home , the contexts in which a child uses EF skills .
METHODS	To evaluate the effectiveness of UOT compared with a social skills intervention ( SS ) , 3rd-5th graders with ASD ( mean IQ = 108 ; UOT n = 47 ; SS n = 20 ) received interventions delivered by school staff in small group sessions .
METHODS	Students were matched for gender , age , race , IQ , ASD symptomotolgy , medication status , and parents ' education .
METHODS	Interventions were matched for ` dose ' of intervention and training .
METHODS	Measures of pre-post change included classroom observations , parent/teacher report , and direct child measures of problem-solving , EF , and social skills .
METHODS	Schools were randomized and evaluators , but not parents or teachers , were blinded to intervention type .
RESULTS	Interventions were administered with high fidelity .
RESULTS	Children in both groups improved with intervention , but mean change scores from pre - to postintervention indicated significantly greater improvements for UOT than SS groups in : problem-solving , flexibility , and planning/organizing .
RESULTS	Also , classroom observations revealed that participants in UOT made greater improvements than SS participants in their ability to follow rules , make transitions , and be flexible .
RESULTS	Children in both groups made equivalent improvements in social skills .
CONCLUSIONS	These data support the effectiveness of the first contextually-based EF intervention for children with ASD .
CONCLUSIONS	UOT improved classroom behavior , flexibility , and problem-solving in children with ASD .
CONCLUSIONS	Individuals with variable background/training in ASD successfully implemented UOT in mainstream educational settings .

###25304843
BACKGROUND	The use of insulin-sensitizing drugs has been shown to improve both the reproductive and the metabolic aspects of PCOS .
BACKGROUND	However , the mechanisms by which metformin exerts its effects in PCOS are still not completely understood .
BACKGROUND	There is growing evidence of a direct effect of metformin on ovarian steroidogenesis , independent of its effects on insulin sensitivity .
METHODS	We evaluated the short-term effects of metformin compared to placebo on basal and LH - stimulated androgen secretion as well as on hormonal and metabolic parameters in 19 women with PCOS during a four-day randomized , double-blinded placebo-controlled clinical trial .
METHODS	In a three month follow-up evaluation , we investigated the longer-term therapeutic effects of metformin on ovulation , metabolic and endocrine parameters .
RESULTS	Compared to placebo , 2days of metformin was associated with a borderline significant reduction in the free androgen index ( FAI ) ( p = 0.05 ) and with a reduction in the serum concentration of LH-stimulated testosterone ( T ) ( p = 0.03 ) .
RESULTS	Following three months of use , a decline in serum T was observed , independent of changes in weight , metabolic parameters , or insulin sensitivity .
CONCLUSIONS	In women with PCOS , Metformin induces a prompt decrease in LH-stimulated T secretion after only several days of use .
CONCLUSIONS	This action precedes the medication 's effects on insulin sensitivity or weight loss .

###24273182
BACKGROUND	We examined the association between Helicobacter pylori infection and the immune response following oral immunization of US adults with attenuated Salmonella Typhi vaccine CVD 908-htrA .
METHODS	Baseline sera from 74 volunteers without a history of typhoid fever who were immunized orally with CVD 908-htrA were tested by enzyme-linked immunosorbent assay for immunoglobin G ( IgG ) antibodies to H. pylori , hepatitis A antibodies ( a marker of low socioeconomic status and exposure to enteric infections ) , and pepsinogen ( PG ) I and II levels ( measures of gastric inflammation ) .
METHODS	IgG against S. Typhi lipopolysaccharide ( LPS ) O and flagella was measured before and 28 days following immunization ; a 4-fold increase in titer from baseline constituted seroconversion .
RESULTS	Seroconversion of S. Typhi IgG LPS antibodies was significantly higher among vaccinees infected with H. pylori versus uninfected subjects : adjusted odds ratio ( OR ) 3.8 , 95 % confidence interval ( CI ) , 1.1-12 .6 ( P = .03 ) .
RESULTS	A low PG I : PG II ratio ( < 5 ) , indicating more advanced corpus gastritis , increased the odds of seroconversion of IgG S. Typhi flagella antibody ( adjusted OR 6.4 , 95 % CI , 1.3-31 .4 ; P = .02 ) .
RESULTS	Hepatitis A infection did not influence the immune response to CVD 908-htrA .
CONCLUSIONS	H. pylori infection and gastric inflammation may enhance humoral immunity to oral attenuated S. Typhi vaccine .

###24647680
OBJECTIVE	Given minority patients ' unequal access to quality care , patient activation and self-management strategies have been suggested as a promising approach to improving mental health care .
OBJECTIVE	To determine whether the DECIDE ( Decide the problem ; Explore the questions ; Closed or open-ended questions ; Identify the who , why , or how of the problem ; Direct questions to your health care professional ; Enjoy a shared solution ) intervention , an educational strategy that teaches patients to ask questions and make collaborative decisions with their health care professional , improves patient activation and self-management , as well as engagement and retention in behavioral health care .
METHODS	In this multisite randomized clinical trial performed from February 1 , 2009 , through October 9 , 2011 ( date of last follow-up interview ) , we recruited 647 English - or Spanish-speaking patients 18 to 70 years old from 13 outpatient community mental health clinics across 5 states and 1 US territory .
METHODS	A total of 722 patients were included in analyses of secondary outcomes .
METHODS	Three DECIDE training sessions delivered by a care manager vs giving patients a brochure on management of behavioral health .
METHODS	Primary outcomes were patient assessment of activation ( Patient Activation Scale ) and self-management ( Perceived Efficacy in Patient-Physician Interactions ) .
METHODS	Secondary outcomes included patient engagement ( proportion of visits attended of those scheduled ) and retention ( attending at least 4 visits in the 6 months after the baseline research assessment ) , collected through medical record review or electronic records .
RESULTS	Patients assigned to DECIDE reported significant increases in activation ( mean = 1.74 , SD = 0.58 ; P = .003 ) and self-management ( mean = 2.42 , SD = 0.90 ; P = .008 ) relative to control patients , but there was no evidence of an effect on engagement or retention in care .
CONCLUSIONS	The DECIDE intervention appears to help patients learn to effectively ask questions and participate in decisions about their behavioral health care , but a health care professional component might be needed to augment engagement in care .
CONCLUSIONS	DECIDE appears to have promise as a strategy for changing the role of minority patients in behavioral health care .
BACKGROUND	clinicaltrials.gov Identifier : NCT01226329

###24888479
BACKGROUND	The promotion of well-being is an important goal of recovery oriented mental health services .
BACKGROUND	No structured , evidence-based intervention exists that aims to increase the well-being in people with severe mental illness such as psychosis .
BACKGROUND	Positive psychotherapy ( PPT ) is a promising intervention for this goal .
BACKGROUND	Standard PPT was adapted for use with people with psychosis in the UK following the Medical Research Council framework for developing and testing complex interventions , resulting in the WELLFOCUS Model describing the intended impact of WELLFOCUS PPT .
BACKGROUND	This study aims to test the WELLFOCUS Model , by piloting the intervention , trial processes , and evaluation strategy .
METHODS	This study is a non-blinded pragmatic pilot RCT comparing WELLFOCUS PPT provided as an 11-session group therapy in addition to treatment as usual to treatment as usual alone .
METHODS	Inclusion criteria are adults ( aged 18-65 years ) with a main diagnosis of psychosis who use mental health services .
METHODS	A target sample of 80 service users with psychosis are recruited from mental health services across the South London and Maudsley NHS Foundation Trust .
METHODS	Participants are randomised in blocks to the intervention and control group .
METHODS	WELLFOCUS PPT is provided to groups by specifically trained and supervised local therapists and members of the research team .
METHODS	Assessments are conducted before randomisation and after the group intervention .
METHODS	The primary outcome measure is well-being assessed by the Warwick-Edinburgh Mental Well-being Scale .
METHODS	Secondary outcomes include good feelings , symptom relief , connectedness , hope , self-worth , empowerment , and meaning .
METHODS	Process evaluation using data collected during the group intervention , post-intervention individual interviews and focus groups with participants , and interviews with trial therapists will complement quantitative outcome data .
CONCLUSIONS	This study will provide data on the feasibility of the intervention and identify necessary adaptations .
CONCLUSIONS	It will allow optimisation of trial processes and inform the evaluation strategy , including sample size calculation , for a future definitive RCT .
BACKGROUND	Current Controlled Trials ISRCTN04199273 - WELLFOCUS study : an intervention to improve well-being in people with psychosis , Date registered : 27 March 2013 , first participant randomised on 26 April 2013 .

###24471975
OBJECTIVE	To examine how different response scales , methods of survey administration , and survey format affect responses to the CAHPS ( Consumer Assessment of Healthcare Providers and Systems ) Clinician and Group ( CG-CAHPS ) survey .
METHODS	A total of 6,500 patients from a university health center were randomly assigned to receive the following : standard 12-page mail surveys using 4-category or 6-category response scales ( on CG-CAHPS composite items ) , telephone surveys using 4-category or 6-category response scales , or four-page mail surveys .
RESULTS	A total of 3,538 patients completed surveys .
RESULTS	Composite score means and provider-level reliabilities did not differ between respondents receiving 4-category or 6-category response scale surveys or between 12-page and four-page mail surveys .
RESULTS	Telephone respondents gave more positive responses than mail respondents .
CONCLUSIONS	We recommend using 4-category response scales and the four-page mail CG-CAHPS survey .

###25369200
BACKGROUND	Postpartum hemorrhage ( PPH ) is a leading cause of maternal death in sub-Saharan Africa .
BACKGROUND	Although the World Health Organization recommends use of oxytocin for prevention of PPH , misoprostol use is increasingly common owing to advantages in shelf life and potential for sublingual administration .
BACKGROUND	There is a lack of data about the comparative efficacy of oxytocin and sublingual misoprostol , particularly at the recommended dose of 600 g , for prevention of PPH during active management of labor .
RESULTS	We performed a double-blind , double-dummy randomized controlled non-inferiority trial between 23 September 2012 and 9 September 2013 at Mbarara Regional Referral Hospital in Uganda .
RESULTS	We randomized 1,140 women to receive 600 g of misoprostol sublingually or 10 IU of oxytocin intramuscularly , along with matching placebos for the treatment they did not receive .
RESULTS	Our primary outcome of interest was PPH , defined as measured blood loss 500 ml within 24 h of delivery .
RESULTS	Secondary outcomes included measured blood loss 1,000 ml ; mean measured blood loss at 1 , 2 , and 24 h after delivery ; death ; requirement for blood transfusion ; hemoglobin changes ; and use of additional uterotonics .
RESULTS	At 24 h postpartum , primary PPH occurred in 163 ( 28.6 % ) participants in the misoprostol group and 99 ( 17.4 % ) participants in the oxytocin group ( relative risk [ RR ] 1.64 , 95 % CI 1.32 to 2.05 , p < 0.001 ; absolute risk difference 11.2 % , 95 % CI 6.44 to 16.1 ) .
RESULTS	Severe PPH occurred in 20 ( 3.6 % ) and 15 ( 2.7 % ) participants in the misoprostol and oxytocin groups , respectively ( RR 1.33 , 95 % CI 0.69 to 2.58 , p = 0.391 ; absolute risk difference 0.9 % , 95 % CI -1.12 to 2.88 ) .
RESULTS	Mean measured blood loss was 341.5 ml ( standard deviation [ SD ] 206.2 ) and 304.2 ml ( SD 190.8 , p = 0.002 ) at 2 h and 484.7 ml ( SD 213.3 ) and 432.8 ml ( SD 203.5 , p < 0.001 ) at 24 h in the misoprostol and oxytocin groups , respectively .
RESULTS	There were no significant differences between the two groups in any other secondary outcomes .
RESULTS	Women in the misoprostol group more commonly experienced shivering ( RR 1.91 , 95 % CI 1.65 to 2.21 , p < 0.001 ) and fevers ( RR 5.20 , 95 % CI 3.15 to 7.21 , p = 0.005 ) .
RESULTS	This study was conducted at a regional referral hospital with capacity for emergency surgery and blood transfusion .
RESULTS	High-risk women were excluded from participation .
CONCLUSIONS	Misoprostol 600 g is inferior to oxytocin 10 IU for prevention of primary PPH in active management of labor .
CONCLUSIONS	These data support use of oxytocin in settings where it is available .
CONCLUSIONS	While not powered to do so , the study found no significant differences in rate of severe PPH , need for blood transfusion , postpartum hemoglobin , change in hemoglobin , or use of additional uterotonics between study groups .
CONCLUSIONS	Further research should focus on clarifying whether and in which sub-populations use of oxytocin would be preferred over sublingual misoprostol .
BACKGROUND	ClinicalTrials.gov NCT01866241 Please see later in the article for the Editors ' Summary .

###26030325
BACKGROUND	Despite current standard of care , many patients at high risk of cardiovascular disease ( CVD ) still have elevated low-density lipoprotein cholesterol ( LDL-C ) levels .
BACKGROUND	Alirocumab is a fully human monoclonal antibody inhibitor of proprotein convertase subtilisin/kexin type 9 .
OBJECTIVE	The objective of the study was to compare the LDL-C-lowering efficacy of adding alirocumab vs other common lipid-lowering strategies .
METHODS	Patients ( n = 355 ) with very high CVD risk and LDL-C levels of 70 mg/dL or greater or high CVD risk and LDL-C of 100 mg/dL or greater on baseline atorvastatin 20 or 40 mg were randomized to one of the following : 1 ) add-on alirocumab 75 mg every 2 weeks ( Q2W ) sc ; 2 ) add-on ezetimibe 10 mg/d ; 3 ) double atorvastatin dose ; or 4 ) for atorvastatin 40 mg regimen only , switch to rosuvastatin 40 mg .
METHODS	For patients not achieving protocol-defined LDL-C goals , the alirocumab dose was increased ( blinded ) at week 12 to 150 mg Q2W .
METHODS	The primary end point was percentage change in calculated LDL-C from baseline to 24 weeks ( intent to treat ) .
RESULTS	Among atorvastatin 20 and 40 mg regimens , respectively , add-on alirocumab reduced LDL-C levels by 44.1 % and 54.0 % ( P < .001 vs all comparators ) ; add-on ezetimibe , 20.5 % and 22.6 % ; doubling of atorvastatin dose , 5.0 % and 4.8 % ; and switching atorvastatin 40 mg to rosuvastatin 40 mg , 21.4 % .
RESULTS	Most alirocumab-treated patients ( 87.2 % and 84.6 % ) achieved their LDL-C goals .
RESULTS	Most alirocumab-treated patients ( 86 % ) maintained their 75-mg Q2W regimen .
RESULTS	Treatment-emergent adverse events occurred in 65.4 % of alirocumab patients vs 64.4 % ezetimibe and 63.8 % double atorvastatin/switch to rosuvastatin ( data were pooled ) .
CONCLUSIONS	Adding alirocumab to atorvastatin provided significantly greater LDL-C reductions vs adding ezetimibe , doubling atorvastatin dose , or switching to rosuvastatin and enabled greater LDL-C goal achievement .

###25528907
OBJECTIVE	Prevention of tick borne diseases in forestry workers is essentially based on the use of appropriate clothing .
OBJECTIVE	The objective of this pragmatic , randomized , controlled trial was to assess the potential benefit of permethrin-treated working trousers for the prevention of tick infestation during forestry work .
METHODS	N = 164 male forestry workers were equipped for a period of 16 weeks with permethrin-treated ( intervention group-I ) or untreated work trousers ( control group-II ) .
METHODS	Subgroups , according to the use of trousers with ( I-1 , II-1 ) or without cut protection lining ( I-2 , II-2 ) were constituted .
METHODS	Tick infestation ( quantity of ticks on the body surface ) was assessed by questionnaire after 16 workdays .
METHODS	Control and intervention groups were compared by calculating the infestation rate ( percentage of subjects with ticks ) and the average number of ticks per workday .
RESULTS	The infestation rate in the intervention group was significantly lower than in the control group ( 36.6 vs. 63.4 % , p = 0.001 ; Fisher-test ) .
RESULTS	Further analysis revealed a significant reduction of tick infestation by permethrin treatment only for subjects wearing trousers without the cut protection lining ( I-2 : 34.2 vs. II-2 : 80.0 % , p < 0.001 ) , while users of cut protection trousers did not benefit from such treated trousers ( I-1 : 38.6 vs. II-1 : 47.6 % , n.s. ) .
RESULTS	Similar results were found for comparisons based on the average number of ticks per workday .
CONCLUSIONS	The use of permethrin-treated trousers does not completely prevent tick infestations .
CONCLUSIONS	Improvement of tick protection has been shown only for some applications , but not in general .
CONCLUSIONS	Additional prevention measures are therefore still indispensable .

###24374400
BACKGROUND	Clinical infection remains a significant problem in implant-based breast reconstruction and is a physical and emotional strain to the breast reconstruction patient .
BACKGROUND	Bacterial strikethrough of draping and gown material is a likely source of infection .
BACKGROUND	Strategies to reduce infection in implant-based breast reconstruction are essential to improve patient outcomes .
OBJECTIVE	The aim of this study is to determine if a disposable draping system is superior to reusable draping materials in the prevention of implant-based breast reconstruction infection .
METHODS	This single-institution , prospective , randomized , single-blinded , IRB-approved study enrolled women with breast cancer who were eligible for implant-based breast reconstruction .
METHODS	The primary endpoint was clinical infection by postoperative day 30 .
METHODS	Secondary endpoints included all other complications encountered throughout the follow-up period and culture data .
METHODS	Demographic data recorded included patient age , body mass index , diabetes , smoking , chemotherapy , radiation , and follow-up .
METHODS	Procedural data recorded included procedure type , procedure length , estimated blood loss , use of acellular dermal matrix , use of muscle flap , and inpatient versus outpatient setting .
RESULTS	From March 2010 through January 2012 , 107 women were randomized and 102 completed the study .
RESULTS	Five patients were determined not to be candidates for reconstruction after randomization .
RESULTS	There were 43 patients in the Reusable Group and 59 patients in the Disposable Group .
RESULTS	There were no significant differences in patient demographic data , procedural data , or the type of procedure performed between groups .
RESULTS	In the Reusable Group , there were 5 infections ( 12 % ) within 30 days compared to 0 ( 0 % ) infections in the Disposable Group ( P = 0.012 ) .
RESULTS	There was no significant difference in secondary complications .
RESULTS	There was a trend for positive wound cultures ( 11 % vs. 3 % , P = 0.10 ) and positive drape cultures ( 17 % vs. 4 % , P = 0.08 ) in patients with clinical infection .
RESULTS	There were no differences in the number of colony-forming units or positive cultures between groups .
CONCLUSIONS	Disposable draping material is superior to a reusable draping system in the prevention of clinical infection within the immediate postoperative period .
CONCLUSIONS	This study did not demonstrate a clear link between intraoperative culture data and the development of clinical infection .
CONCLUSIONS	A completely disposable gown and draping system is recommended during implant-based breast reconstruction .

###24315520
BACKGROUND	Drawbacks exist with the standard treatment ( four-layer compression bandages ) for venous leg ulcers .
BACKGROUND	We have therefore compared the clinical effectiveness and cost-effectiveness of two-layer compression hosiery with the four-layer bandage for the treatment of such ulcers .
METHODS	We undertook this pragmatic , open , randomised controlled trial with two parallel groups in 34 centres in England and Northern Ireland .
METHODS	The centres were community nurse teams or services , family doctor practices , leg ulcer clinics , tissue viability clinics or services , and wound clinics .
METHODS	Participants were aged 18 years or older with a venous leg ulcer and an ankle brachial pressure index of at least 08 , and were tolerant of high compression .
METHODS	We randomly allocated participants ( 1:1 ) to receive two-layer compression hosiery or a four-layer bandage , using a remote randomisation service and prevalidated computer randomisation program .
METHODS	Participants were stratified by ulcer duration and ulcer area with permuted blocks ( block sizes four and six ) .
METHODS	The primary endpoint was time to ulcer healing , with a maximum follow-up of 12 months .
METHODS	Although participants and health-care providers were not masked to treatment allocation , the primary endpoint was measured by masked assessment of photographs .
METHODS	Primary analysis was intention to treat with Cox regression , with adjustment for ulcer area , ulcer duration , physical mobility , and centre .
METHODS	This trial is registered with the ISRCTN register , number ISRCTN49373072 .
RESULTS	We randomly allocated 457 participants to the two treatment groups : 230 to two-layer hosiery and 227 to the four-layer bandage , of whom 453 ( 230 hosiery and 223 bandage ) contributed data for analysis .
RESULTS	Median time to ulcer healing was 99 days ( 95 % CI 84-126 ) in the hosiery group and 98 days ( 85-112 ) in the bandage group , and the proportion of ulcers healing was much the same in the two groups ( 709 % hosiery and 704 % bandage ) .
RESULTS	More hosiery participants changed their allocated treatment ( 383 % hosiery vs 270 % bandage ; p = 002 ) .
RESULTS	300 participants had 895 adverse events , of which 85 ( 95 % ) were classed as serious but unrelated to trial treatment .
CONCLUSIONS	Two-layer compression hosiery is a viable alternative to the four-layer bandage-it is equally as effective at healing venous leg ulcers .
CONCLUSIONS	However , a higher rate of treatment changes in participants in the hosiery group than in the bandage group suggests that hosiery might not be suitable for all patients .
BACKGROUND	NIHR Health Technology Assessment programme ( 07/60/26 ) .

###25262254
BACKGROUND	Ranolazine reduces the frequency of angina and use of sublingual nitroglycerin ( SL NTG ) in stable angina patients with type 2 diabetes ( T2DM ) .
BACKGROUND	Because pre-clinical data suggest that myocardial late sodium current ( INaL ) , the target of ranolazine , is increased by hyperglycemia , we investigated whether the efficacy of ranolazine was influenced by glycemic control .
METHODS	TERISA was a multinational , randomized , double-blind trial of ranolazine vs. placebo in patients with T2DM and stable angina .
METHODS	Anginal episodes and SL NTG use were recorded daily in an electronic diary .
METHODS	Health status was evaluated at baseline and 8weeks post-randomization using the Seattle Angina Questionnaire ( SAQ ) .
METHODS	The interaction between baseline HbA1c and treatment effect was tested across endpoints using analysis of covariance models , with HbA1c as a continuous variable with restricted cubic splines .
RESULTS	The study included 913 patients , with mean age 63.6 years , 39 % women , mean T2DM duration 7.4 years , and mean HbA1c of 7.3 % .
RESULTS	Heterogeneity of efficacy by HbA1c was observed for the primary endpoint of angina frequency ( Pinteraction = .027 ) , the key secondary endpoint of SL NTG use ( Pinteraction = .030 ) , SAQ angina frequency ( Pinteraction = .001 ) , and SAQ treatment satisfaction ( Pinteraction = .025 ) with greater efficacy of ranolazine in those with higher HbA1c values , increasing continuously from HbA1c levels > 6.5 % .
CONCLUSIONS	Among patients with T2DM and stable angina , the therapeutic benefits of ranolazine were greater in those with higher HbA1c values .
CONCLUSIONS	These data suggest that ranolazine is particularly beneficial in patients with stable angina who have suboptimally controlled T2DM .

###25503455
OBJECTIVE	To identify patient baseline characteristics that predict recognition acuity at 4.5 years of age in the Infant Aphakia Treatment Study , a study of patients with monocular infantile cataracts .
METHODS	We analyzed baseline characteristics of the 114 infants enrolled in the Infant Aphakia Treatment Study to determine which were most predictive of visual outcome at 4.5 years of age .
METHODS	All infants underwent cataract surgery between 1 and 7 months of age .
METHODS	Monocular acuity was assessed at 4.5 years of age by a traveling examiner using the Amblyopia Treatment Study HOTV protocol .
RESULTS	Age at cataract surgery was weakly associated with visual acuity ( Spearman rank correlation coefficient = 0.19 , P = 0.041 ) with median visual acuity better among the younger patients ( 28-48 days : 0.50 logMAR , 49-210 days : 1.10 logMAR , P = 0.046 ) .
RESULTS	Patients from families with private insurance had significantly better median visual acuity ( 0.60 vs. 1.40 logMAR , P = 0.0004 ) .
RESULTS	No other baseline characteristic revealed a significant bivariate relationship with visual acuity .
RESULTS	A multiple linear regression relating visual acuity to all baseline characteristics demonstrated that only the availability of private insurance was statistically significant , accounting for 12 % of the variance .
CONCLUSIONS	This analysis concurs with previous studies that early surgery is important for good visual outcomes in patients with unilateral infantile cataracts .
CONCLUSIONS	The fact that only one baseline variable ( private insurance ) contributed to the multivariate analysis , accounting for 12 % of the variance , suggests that predicting visual outcome for these patients is complicated at best , and can not be estimated from baseline characteristics alone .
CONCLUSIONS	( ClinicalTrials.gov number , NCT00212134 . )

###25227499
OBJECTIVE	To compare the efficacy and safety of bevacizumab versus ranibizumab when administered according to a treat-and-extend protocol for the treatment of neovascular age-related macular degeneration ( AMD ) .
METHODS	Multicenter , randomized , noninferiority trial with a noninferiority limit of 5 letters .
METHODS	Patients aged 50 years with previously untreated neovascular AMD in 1 eye and best-corrected visual acuity ( BCVA ) between 20/25 and 20/320 .
METHODS	Patients were randomly assigned to receive ranibizumab 0.5 mg or bevacizumab 1.25 mg intravitreal injections .
METHODS	Monthly injections were given until inactive disease was achieved .
METHODS	The patients were then followed with a gradual extension of treatment interval by 2 weeks at a time up to a maximum of 12 weeks .
METHODS	If signs of recurrent disease appeared , the treatment interval was shortened by 2 weeks at a time .
METHODS	Change in visual acuity at 1 year .
RESULTS	Between March 2009 and July 2012 , 441 patients were randomized at 10 ophthalmological centers in Norway .
RESULTS	The 1-year visit was completed by 371 patients .
RESULTS	In the per protocol analysis at 1 year , bevacizumab was equivalent to ranibizumab , with 7.9 and 8.2 mean letters gained , respectively ( 95 % confidence interval [ CI ] of mean difference , -2.4 to 2.9 ; P = 0.845 ) .
RESULTS	The intention-to-treat analysis was concordant .
RESULTS	There was no significant difference in measured central retinal thickness ( CRT ) , with a mean decrease of -112 m for bevacizumab and -120 m for ranibizumab ( 95 % CI of mean difference , -13 to 28 ; P = 0.460 ) .
RESULTS	There was a statistically significant difference ( P = 0.001 ) between the drugs regarding the number of treatments : 8.9 for bevacizumab and 8.0 for ranibizumab .
RESULTS	There were fewer arteriothrombotic events in the bevacizumab group ( 1.4 % ) than in the ranibizumab group ( 4.5 % ) ( P = 0.050 ) and significantly more cardiac events in the ranibizumab group ( P = 0.036 ) .
RESULTS	However , patients treated with ranibizumab more often had a history of myocardial infarction ( P = 0.021 ) .
CONCLUSIONS	Bevacizumab and ranibizumab had equivalent effects on visual acuity at 1 year when administered according to a treat-and-extend protocol .
CONCLUSIONS	The visual acuity results at 1 year were comparable to those of other clinical trials with monthly treatment .
CONCLUSIONS	The numbers of serious adverse events were small .

###24810310
OBJECTIVE	To compare pressure ulcer healing rates in patients supplemented with a specialised amino acid mixture containing ( beta ) - hydroxy ( beta ) - methylbutyrate ( HMB ) , arginine and glutamine , and standard oral nutritional supplements versus patients supplemented with oral nutritional supplements and a placebo mixture .
METHODS	Twenty-three inpatients with stage II , III or IV pressure ulcers in an acute care hospital were randomised to recieve ( A ) a HMB , arginine and glutamine mixture twice daily alongside oral nutritional supplements ( n = 11 ) or ( B ) standard nutritional care alongside oral nutritional supplements ( n = 12 ) for 2 weeks .
METHODS	Pressure ulcers were measured weekly for area , depth and Pressure Ulcer Scale for Healing ( PUSH ) scores .
METHODS	The proportion of viable tissue was determined based on area of wound tracing .
METHODS	Weekly laboratory tests were performed to measure C-reactive protein and pre-albumin levels .
METHODS	This trial is registered at http://ClinicalTrials.gov under NCT01090076 .
RESULTS	There was no difference between anthropometrical measurements , biochemical parameters and nutritional intake pre - and post - study .
RESULTS	Wound area did not decrease significantly in the short term for both groups .
RESULTS	The proportion of viable tissues increased within 2 weeks on HMB , arginine and glutamine supplementation ( p = 0.02 ) .
RESULTS	PUSH scores showed significant improvement within 1 week of supplementation for the experimental group ( p = 0.013 ) .
CONCLUSIONS	The use of specialised amino acid does not appear to reduce wound size and PUSH scores but may improve tissue viability after 2 weeks .
CONCLUSIONS	Further confirmation on a larger scale is required to determine the benefits of supplementing additional HMB , arginine and glutamine in patients with pressure ulcers .

###25760804
OBJECTIVE	Alcohol use disorder is one of the leading causes of disability worldwide .
OBJECTIVE	While effective pharmacological treatments exist , they are efficacious only in certain individuals , contributing to their limited use .
OBJECTIVE	Secondary analysis of clinical trial data suggests that a functional polymorphism ( rs1799971 , Asn40Asp ) of the - opioid receptor gene ( OPRM1 ) is associated with the risk of relapse to heavy drinking following treatment with the opioid antagonist naltrexone .
OBJECTIVE	To prospectively examine whether rs1799971 is predictive of naltrexone treatment response .
METHODS	We conducted a 12-week , double-blind , randomized clinical trial of naltrexone vs placebo in individuals with alcohol dependence ( intent-to-treat analysis ) .
METHODS	Participants were randomly assigned to study treatment based on the presence of 1 or 2 copies of the Asp40 allele compared with those homozygous for the Asn40 allele ( 2 2 cell design ) .
METHODS	Recruitment occurred between January 2009 and September 2013 .
METHODS	All participants were seen in an outpatient clinical setting .
METHODS	A convenience sample of participants ( n = 221 ) was recruited from 5 sites .
METHODS	All participants met DSM-IV criteria for alcohol dependence , with no concurrent psychotic or manic symptoms , no use of concurrent psychotropic medications , and no current dependence on illicit substances .
METHODS	The study drug was naltrexone ( 50 mg ) given once daily or corresponding placebo .
METHODS	The primary study outcome measure was relapse to heavy drinking measured using the timeline follow-back method .
RESULTS	There was no evidence of a genotype treatment interaction on the primary outcome of heavy drinking ( P = .32 ) .
RESULTS	In the Asn40 group , the observed effect of naltrexone was similar to that in previous trials ( odds ratio , 0.69 ; 95 % CI , 0.41-1 .18 ; P = .17 ) , with a very small naltrexone effect in the Asp40 group ( odds ratio , 1.10 ; 95 % CI , 0.52-2 .31 ; P = .80 ) , contrary to the pattern expected a priori .
RESULTS	A significant reduction in heavy drinking occurred across all groups ( P = .001 ) .
RESULTS	Other drinking outcomes , and all secondary outcomes , demonstrated similar time effects , with no genotype treatment interaction .
CONCLUSIONS	The results of this study do not support the hypothesis that the Asp40 allele moderates the response to naltrexone treatment .
CONCLUSIONS	It is premature to use the Asn40Asp polymorphism as a biomarker to predict the response to naltrexone treatment of alcohol dependence .
BACKGROUND	clinicaltrials.gov Identifier : NCT00831272 .

###24662398
BACKGROUND	YUKAWA is a 12-week , randomized , double-blind , placebo-controlled , phase 2 study evaluating the efficacy and safety of evolocumab ( AMG 145 ) in statin-treated Japanese patients at high cardiovascular risk .
RESULTS	310 eligible patients receiving stable statin ( ezetimibe ) therapy were randomized to 1 of 6 treatments : placebo every 2 weeks ( Q2W ) or monthly ( QM ) , evolocumab 70 mg or 140 mg Q2W , or evolocumab 280 mg or 420 mg QM .
RESULTS	The primary endpoint was the percentage change from baseline in low-density lipoprotein cholesterol ( LDL-C ) measured by preparative ultracentrifugation ( UC ) .
RESULTS	Secondary endpoints included percentage changes in other lipid parameters and the proportion of patients with LDL-C < 1.8 mmol/L .
RESULTS	Mean ( SD ) age was 62 ( 10 ) years ; 37 % were female ; and the mean ( SD ) baseline LDL-C was 3.7 ( 0.5 ) mmol/L ( by UC ) .
RESULTS	Mean ( SE ) changes vs. placebo in LDL-C were greatest in the high-dose groups : -68.6 ( 3.0 ) % and -63.9 ( 3.2 ) % with 140 mg Q2W and 420 mg QM dosing , respectively .
RESULTS	Up to 96 % of evolocumab-treated patients achieved LDL-C < 1.8 mmol/L .
RESULTS	Adverse events ( AEs ) were more frequent in evolocumab ( 51 % ) vs. placebo ( 38 % ) patients ; 4 patients taking evolocumab discontinued treatment because of an AE .
RESULTS	There were no significant differences in AE rates based on dose or dose frequency .
CONCLUSIONS	In Japanese patients at high cardiovascular risk with hypercholesterolemia on stable statin therapy , evolocumab significantly reduced LDL-C and was well tolerated during this 12-week study .

###26241434
OBJECTIVE	To assess change in overactive bladder ( OAB ) symptoms up to 5 years after surgery and to identify associated predictors of change from baseline .
METHODS	This is a secondary analysis of data from three multicenter urinary incontinence ( UI ) surgical trials of women with stress-predominant mixed UI assigned to Burch colposuspension , autologous fascial sling , or retropubic or transobturator midurethral slings .
METHODS	The primary outcome was improvement of 70 % or greater from baseline in symptoms measured by the Urinary Distress Inventory-Irritative subscale .
METHODS	Surgical groups were compared within respective trials .
METHODS	Generalized linear models were fit using 1-year and up to 5-year data .
RESULTS	Significant improvements in Urinary Distress Inventory-Irritative scores were reported by each surgical group 1 year after surgery ( P < .001 ) .
RESULTS	Most women ( 50-71 % ) reported improvement in OAB symptoms .
RESULTS	Improvements were similar between midurethral sling groups at 1 year ( 65.5 % compared with 70.7 % , P = .32 ; odds ratio [ OR ] 0.83 , 95 % confidence interval [ CI ] 0.57-1 .20 for retropubic compared with transobturator sling ) and throughout the 5-year follow-up period .
RESULTS	More women reported OAB symptom improvement after Burch compared with pubovaginal sling ( 67.9 % compared with 56.6 % , P = .01 ; OR 1.59 , 95 % CI 1.10-2 .31 for Burch compared with sling ) ; this group difference at 1 year persisted throughout the 5-year follow-up .
RESULTS	At 1-year , 50.0-64 .3 % of patients reported 70 % greater improvement in UI .
RESULTS	This proportion declined to 36.5-54 .1 % at 5 years ( P < .001 ) .
RESULTS	Preoperative use of anticholinergics and urodynamic parameters was not predictive of OAB symptom change after surgery .
CONCLUSIONS	Most women with stress-predominant mixed UI experienced significant improvement in OAB symptoms after incontinence surgery although this initial improvement diminished over time .
CONCLUSIONS	Obesity blunted symptom improvement .
METHODS	II .

###24446022
BACKGROUND	Early recurrence of atrial fibrillation ( ERAF ) is common after radiofrequency catheter ablation for AF .
BACKGROUND	We sought to determine the incidence and prognostic significance of ERAF after cryoballoon ablation .
BACKGROUND	Moreover , the benefit of early reablation for ERAF after cryoballoon ablation is undetermined .
RESULTS	The Sustained Treatment of Paroxysmal Atrial Fibrillation ( STOP AF ) trial randomized 245 patients with paroxysmal AF to medical therapy versus cryoballoon-based pulmonary vein ablation .
RESULTS	Patients were followed for 12 months .
RESULTS	ERAF was defined as any recurrence of AF > 30 seconds during the first 3 months of follow-up .
RESULTS	Late recurrence ( LR ) was defined as any recurrence of AF > 30 seconds between 3 and 12 months .
RESULTS	Of the 163 patients randomized to cryoablation , 84 patients experienced ERAF ( 51.5 % ) .
RESULTS	The only significant factor associated with ERAF was male sex ( hazard ratio [ HR ] , 2.18 ; 95 % confidence interval [ CI ] , 1.03-4 .61 ; P = 0.041 ) .
RESULTS	LR was observed in 41 patients ( 25.1 % ) , and was significantly related to ERAF ( 55.6 % LR with ERAF versus 12.7 % without ERAF ; P < 0.001 ) .
RESULTS	Among patients with ERAF , only current tobacco use ( HR , 3.84 ; 95 % CI , 1.82-8 .11 ; P < 0.001 ) was associated with LR .
RESULTS	Conversely , early reablation was associated with greater freedom from LR ( 3.3 % LR with early reablation versus 55.6 % without ; HR , 0.04 ; 95 % CI , 0.01-0 .32 ; P = 0.002 ) .
CONCLUSIONS	ERAF after cryoballoon ablation occurs in 50 % of patients and is strongly associated with LR .
CONCLUSIONS	Early reablation for ERAF is associated with excellent long-term freedom from recurrent AF .

###24220342
BACKGROUND	A new model of complex diabetes care is provided by a multidisciplinary team which incorporates general practitioner ( GP ) Clinical Fellows supported by an Endocrinologist and diabetes educator within a community-based general practice setting .
BACKGROUND	This study evaluates the health and clinical benefits of the new model of care , assesses the acceptability of the model to patients , GPs and other health professionals , and examines the cost-effectiveness of the model .
METHODS	The study is an open , non-inferiority randomised controlled trial with data collected at baseline , 6 and 12 months .
METHODS	Participants are identified from new patients on hospital-based diabetes outpatient clinic waiting lists and new GP referrals .
METHODS	Eligible consenting patients are randomised to either a community practice site ( intervention ) or a hospital site ( usual care ) .
METHODS	In the intervention model , medical care is led by a GP Clinical Fellow in partnership with an Endocrinologist .
METHODS	Quantitative measures include clinical indicators with HbA1c as the primary outcome ; patient-reported outcomes include health-related quality of life , mental health and satisfaction with care .
METHODS	Qualitative methods will be used to explore the perspectives and experiences of patients and providers regarding the new model of care .
METHODS	An economic evaluation will also be undertaken .
CONCLUSIONS	This model of care seeks to improve the quality and safety of healthcare at the interface between the hospital and primary care sectors for patients with complex diabetes .
CONCLUSIONS	The study will provide empirical evidence about the impact of the model of care on health outcomes , patient and clinician satisfaction , as well as any economic impacts .
BACKGROUND	Clinical Trials Registry Number : ACTRN12612000380897 .

###25267796
OBJECTIVE	The effect of hypoglycemia related to treatment of type 2 diabetes mellitus ( T2DM ) on brain structure remains unclear .
OBJECTIVE	We aimed to assess whether symptomatic severe hypoglycemia is associated with brain atrophy and/or white matter abnormalities .
METHODS	We included T2DM participants with brain MRI from the Action to Control Cardiovascular Risk in Diabetes-Memory in Diabetes ( ACCORD-MIND ) trial .
METHODS	Symptomatic severe hypoglycemia was defined as blood glucose < 2.8 mmol/L or symptoms resolved with treatments that required the assistance of another person or medical assistance ( hypoglycemia requiring assistance [ HA ] ) .
METHODS	Standardized brain MRI was performed at baseline and at 40 months .
METHODS	Total brain volume ( TBV ) and abnormal white matter ( AWM ) volume were calculated using an automated computer algorithm .
METHODS	Brain MRI scans of hypoglycemic participants were also reviewed for local disease .
RESULTS	Of the 503 T2DM participants ( mean age , 62 years ) with successful baseline and 40-month brain MRI , 28 had at least one HA episode during the 40-month follow-up .
RESULTS	Compared with participants without HA , those with HA had marginally significant less atrophy ( less decrease in TBV ) from baseline to 40 months ( -9.55 [ 95 % CI -15.21 , -3.90 ] vs. -15.38 [ 95 % CI -16.64 , -14.12 ] , P = 0.051 ) , and no significant increase of AWM volume ( 2.06 [ 95 % CI 1.71 , 2.49 ] vs. 1.84 [ 95 % CI 1.76 , 1.91 ] , P = 0.247 ) .
RESULTS	In addition , no unexpected local signal changes or volume loss were seen on hypoglycemic participants ' brain MRI scans .
CONCLUSIONS	Our study suggests that hypoglycemia related to T2DM treatment may not accentuate brain pathology , specifically brain atrophy or white matter abnormalities .

###24395987
BACKGROUND	Emotional support has traditionally been conceived as something a breast cancer patient receives .
BACKGROUND	However , this framework may obscure a more complex process , facilitated by the emerging social media environment , which includes the effects of composing and sending messages to others .
BACKGROUND	Accordingly , this study explores the effects of expression and reception of emotional support messages in online groups and the importance of bonding as a mediator influencing the coping strategies of breast cancer patients .
METHODS	Data were collected as part of two National Cancer Institute-funded randomized clinical trials .
METHODS	Eligible subjects were within 2 months of diagnosis of primary breast cancer or recurrence .
METHODS	Expression and reception of emotionally supportive messages were tracked and coded for 237 breast cancer patients .
METHODS	Analysis resulted from merging 1 ) computer-aided content analysis of discussion posts , 2 ) action log analysis of system use , and 3 ) longitudinal survey data .
RESULTS	As expected , perceived bonding was positively related to all four coping strategies ( active coping : = 0.251 , P = .000 ; positive reframing : = 0.288 , P = .000 ; planning : = 0.213 , P = .006 ; humor : = 0.159 , P = .009 ) .
RESULTS	More importantly , expression ( = 0.138 , P = .027 ) , but not reception ( = -0.018 , P = .741 ) , of emotional support increases perceived bonding , which in turn mediates the effects on patients ' positive coping strategies .
CONCLUSIONS	There is increasing importance for scholars to distinguish the effects of expression from reception to understand the processes involved in producing psychosocial benefits .
CONCLUSIONS	This study shows that emotional support is more than something cancer patients receive ; it is part of an active , complex process that can be facilitated by social media .

###24729586
OBJECTIVE	Efavirenz is widely prescribed for HIV-1 infection , and CYP2B6 polymorphisms 516GT and 983TC define efavirenz slow metabolizer genotypes .
OBJECTIVE	To identify genetic predictors of higher plasma efavirenz concentrations beyond these two common functional alleles , we characterized associations with mid-dosing interval efavirenz concentrations in 84 HIV-infected adults , all carrying two copies of these major loss-of-function CYP2B6 alleles .
METHODS	Study participants had been randomized to efavirenz-containing regimens in prospective clinical trials and had available plasma efavirenz assay data .
METHODS	Analyses focused on secondary metabolism pathway polymorphisms CYP2A6 -48 TG ( rs28399433 ) , UGT2B7 735AG ( rs28365062 ) and UGT2B7 802TC ( rs7439366 ) .
METHODS	Exploratory analyses also considered 196 polymorphisms and 8 copy number variants in 41 drug metabolism/transport genes .
METHODS	Mid-dosing interval efavirenz concentrations at steady-state were obtained 8 h but < 19 h post-dose .
METHODS	Linear regression was used to test for associations between polymorphisms and log-transformed efavirenz concentrations .
RESULTS	Increased efavirenz concentrations were associated with CYP2A6 -48 TG in all subjects ( P = 3.810 ( -4 ) ) and in Black subjects ( P = 0.027 ) and White subjects ( P = 0.0011 ) analysed separately ; and with UGT2B7 735 G/G homozygosity in all subjects ( P = 0.006 ) and in Black subjects ( P = 0.046 ) and White subjects ( P = 0.062 ) analysed separately .
RESULTS	In a multivariable model , CYP2A6 -48 TG and UGT2B7 735 G/G homozygosity remained significant ( P < 0.05 for each ) .
RESULTS	No additional polymorphisms or copy number variants were significantly associated with efavirenz concentrations .
CONCLUSIONS	Among individuals with a CYP2B6 slow metabolizer genotype , CYP2A6 and possibly UGT2B7 polymorphisms contribute to even higher efavirenz concentrations .

###25635887
BACKGROUND	Retrospective series report varied rates of bleeding and infection with external ventricular drainage ( EVD ) .
BACKGROUND	There have been no prospective studies of these risks with systematic surveillance , threshold definitions , or independent adjudication .
OBJECTIVE	To analyze the rate of complications in the ongoing Clot Lysis : Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III ( CLEAR III ) trial , providing a comparison with a systematic review of complications of EVD in the literature .
METHODS	Patients were prospectively enrolled in the CLEAR III trial after placement of an EVD for obstructive intraventricular hemorrhage and randomized to receive recombinant tissue-type plasminogen activator or placebo .
METHODS	We counted any detected new hemorrhage ( catheter tract hemorrhage or any other distant hemorrhage ) on computed tomography scan within 30 days from the randomization .
METHODS	Meta-analysis of published series of EVD placement was compiled with STATA software .
RESULTS	Growing or unstable hemorrhage was reported as a cause of exclusion from the trial in 74 of 5707 cases ( 1.3 % ) screened for CLEAR III .
RESULTS	The first 250 patients enrolled have completed adjudication of adverse events .
RESULTS	Forty-two subjects ( 16.8 % ) experienced 1 new bleeds or expansions , and 6 of 250 subjects ( 2.4 % ) suffered symptomatic hemorrhages .
RESULTS	Eleven cases ( 4.4 % ) had culture-proven bacterial meningitis or ventriculitis .
CONCLUSIONS	Risks of bleeding and infection in the ongoing CLEAR III trial are comparable to those previously reported in EVD case series .
CONCLUSIONS	In the present study , rates of new bleeds and bacterial meningitis/ventriculitis are very low despite multiple daily injections , blood in the ventricles , the use of thrombolysis in half the cases , and generalization to > 60 trial sites .

###25054304
OBJECTIVE	To assess the impact of between-training-sessions recovery strategies ( passive [ PAS ] , active [ ACT ] , cold-water immersion [ CWI ] , and ingestion of a recovery drink [ NUTR ] ) on maximal cycling performance , perceptions of delayed-onset muscle soreness ( DOMS ) , and fatigue in world-class BMX riders .
METHODS	Eleven elite BMX athletes , members of the French national team ( top country in the 2011 international ranking , 4 medals at the 2012 World Championships , top European country ) , participated in the study , which involved standardized training periods .
METHODS	Athletes performed 3 maximal-sprint power tests : the first day of the week before the training session and before and after training on the third day of the week ( D3 ) .
METHODS	The recovery strategy was randomly assigned to each participant on day 2 immediately after the last training period of the day .
METHODS	Perceptions of DOMS and general fatigue were recorded on D3 .
RESULTS	After training on D3 , the decrease in maximal-sprint power ( Pmax ) was significantly greater for PAS than with CWI ( P = .02 ) and NUTR ( P = .018 ) .
RESULTS	Similar results were found with ACT ( vs CWI P = .044 , and vs NUTR P = .042 ) .
RESULTS	Self-reported DOMS and fatigue were significantly greater after PAS than after other strategies .
CONCLUSIONS	For elite BMX riders , between training days , nutritional and/or CWI recovery strategies appear to be best for reducing muscle fatigue and increasing the capacity to withstand the training schedule .

###24820858
OBJECTIVE	In this randomized clinical trial ginger efficacy for prevention of antiretroviral-induced nausea and vomiting ( N/V ) was investigated .
METHODS	From July 2011 until the end of June 2013 , 102 HIV positive patients attending the HIV clinic of Imam Khomeini Hospital participated in the study .
METHODS	In a double blinded manner , participants randomly received either 500 mg ginger or placebo two times per day , 30 min before each dose of antiretroviral regimen for 14 days .
METHODS	The severity of nausea was assessed based on the visual analogue scale .
METHODS	The number of vomiting episodes were also recorded during the study period .
RESULTS	A total of 46 ( 90.2 % ) and 29 ( 56.4 % ) of the patients in placebo and ginger groups experienced some degree of nausea during the first 2 weeks of antiretroviral therapy ( ART ) , respectively ( p = 0.001 ) .
RESULTS	Frequency of mild , moderate and severe nausea were significantly lower in the ginger than placebo group ( p = 0.001 ) .
RESULTS	Also , 24 ( 47.1 % ) and 5 ( 9.8 % ) of the patients in the placebo and ginger groups reported at least one episode of vomiting during their time on ART , respectively ( p = 0.01 ) .
CONCLUSIONS	Ginger was effective in ameliorating of antiretroviral-induced N/V .

###25025755
OBJECTIVE	Chronic myeloid leukemia ( CML ) treatment relies on tyrosine kinase inhibitors ( TKIs ) , but their use can be associated with low-grade adverse events ( AEs ) .
OBJECTIVE	This analysis aimed to identify the low-grade AEs which significantly impact the Health Related Quality of Life ( HRQoL ) of CML patients in chronic phase ( CP ) and to compare the incidence of such AEs among nilotinib - and imatinib-treated patients .
METHODS	Data from the 48 month ENESTnd trial were used ( N = 593 patients ) .
METHODS	HRQoL was assessed using generic ( SF-36 ) and leukemia-specific ( FACT-Leu ) HRQoL surveys .
METHODS	AEs were categorized into 26 system organ classes .
RESULTS	In the adjusted regression model , five low-grade AE categories - gastrointestinal disorders , blood and lymphatic system disorders , general disorders and administration site conditions , musculoskeletal disorders , and psychiatric disorders - significantly impaired at least one HRQoL score .
RESULTS	The incidence rate of these five AE categories was either significantly lower for nilotinib than imatinib or not different between the two drugs .
RESULTS	The AE categories with lower incidence for both nilotinib 300mg BID and 400mg BID versus imatinib 400mg daily were gastrointestinal , blood and lymphatic system , and musculoskeletal ; nilotinib 300mg BID had lower incidence than imatinib for general disorders .
CONCLUSIONS	Low-grade AEs were grouped and analyzed by system organ class category , so the effect of some rare individual AEs on HRQoL may have been missed .
CONCLUSIONS	The impact of low-grade AEs on HRQoL should be taken into account , along with other factors , when selecting the optimal treatment for patients newly diagnosed with CML-CP .

###24590990
OBJECTIVE	To assess the difference between drainage and non-drainage after total hip arthroplasty ( THA ) in Chinese subjects by evaluating post-operative complications and joint function .
METHODS	One hundred and sixty-eight patients undergoing THA were randomly allocated into drainage ( 83 patients ) and non-drainage groups ( 85 patients ) .
METHODS	All surgeries were performed by one surgical team using the same pre - , intra - , and postoperative techniques .
METHODS	Measured items included : hemoglobin ( Hb ) , superficial and deep wound infection , volume of blood transfusion , wound hematoma thickness , range of motion ( ROM ) of the hip , wound healing time , ecchymosis and tension vesicles around the wound .
RESULTS	Early after THA , the Hb decreased significantly in the drainage group .
RESULTS	There was no significant difference between non-drainage and drainage groups in need for or volume of blood transfusions ( 9.6 % vs 8.2 % , P = 0.100 ; 3.8 units vs 2.9 units , P = 0.089 , respectively ) .
RESULTS	In the non-drainage group , the incidence of superficial infection , ecchymosis and tension vesicles was significantly higher than in the drainage group ( 10.6 % vs 2.4 % , P = 0.031 ; 12.9 % vs 3.6 % , P = 0.026 ; 16.5 % vs 4.8 % , P = 0.013 , respectively ) .
RESULTS	In addition , the non-drainage group had a greater volume of hematomas ( P = 0.000 ) .
RESULTS	Patients in the non-drainage group had smaller ROMs early after surgery but the final ROMs did not differ significantly between groups .
RESULTS	No deep infection occurred in either group .
CONCLUSIONS	Non-drainage may reduce postoperative blood loss but has no benefits regarding blood transfusion or deep infection .
CONCLUSIONS	It may cause more post-operative complications because of restriction of early postoperative exercise by pain and swelling .
CONCLUSIONS	Therefore we suggest routine use of drainage after THA .

###24282136
BACKGROUND	Using the reverse Trendelenburg position ( RTP ) during functional endoscopic sinus surgery ( FESS ) is a safe , simple , and cost-free method that has been found to reduce intraoperative blood loss .
BACKGROUND	However , the critical angle of RTP that produces the least amount of bleeding without compromising surgical technique and safety remains unanswered .
BACKGROUND	The objective of this study was to assess the effects of 5-degree , 10-degree , and 20-degree RTP ( 5-RTP , 10-RTP , and 20-RTP , respectively ) on intraoperative bleeding during FESS .
METHODS	This double-blind randomized controlled trial involved 75 patients with chronic rhinosinusitis ( CRS ) with and without nasal polyposis undergoing FESS .
METHODS	Twenty-five patients were enrolled into each group : 5-RTP , 10-RTP , and 20-RTP .
METHODS	Boezaart endoscopic field-of-view score ( BS ) , total blood loss ( TBL ) , mean arterial blood pressure ( MABP ) , operating time , and blood loss per minute were recorded .
METHODS	An intention-to-treat analysis was used , with a Bonferroni adjustment for multiple comparisons .
RESULTS	Intervention groups were comparable in age , sex , nasal polyposis , and disease severity .
RESULTS	Mean values of BS and TBL were as follows : 5-RTP ( 2.0 , 231 mL ) , 10-RTP ( 1.8 , 230 mL ) , and 20-RTP ( 1.4 , 135 mL ) .
RESULTS	The differences in means were significant for BS ( p < 0.01 ) and TBL ( p = 0.03 ) .
RESULTS	There was no significant difference in MABP ( p = 0.85 ) , operating time ( p = 0.10 ) , or blood loss per minute ( p = 0.11 ) between the 3 groups .
RESULTS	Pairwise comparison between 5-RTP vs 20-RTP found significant difference in BS ( p < 0.01 ) but not TBL ( p = 0.04 ) .
RESULTS	Significance was not found in similar comparisons of 10-RTP vs 20-RTP and 5-RTP vs 10-RTP ( p > 0.03 ) .
CONCLUSIONS	FESS in 20-RTP produced the best BS and lowest blood loss without compromising surgical technique .

###24716631
BACKGROUND	This paper aimed to develop a short version of the 32-item Ageing Perceptions Questionnaire ( APQ ) , a multi-dimensional measure based on Leventhal 's self-regulation model .
BACKGROUND	Ageing perceptions are a key area of interest for large-scale surveys of ageing populations .
BACKGROUND	As these studies capture a broad range of health and social variables , included instruments need to be as concise as possible .
METHODS	Data from the Irish Longitudinal Study of Ageing ( TILDA ) , a representative sample of community-dwelling individuals aged 50 + ( n = 6,718 ) , was used to revise the scale .
METHODS	Items for exclusion were identified by examining conceptual content , descriptive statistics , and by detecting sources of poor model fit using confirmatory factor analysis ( CFA ) .
METHODS	Potential combinations of dimensions were also tested using CFA .
METHODS	Finally , we identified any dimensions that could be excluded without limiting the conceptual coverage and coherence of the scale .
METHODS	Model modifications were done sequentially and with regard to theoretical considerations .
METHODS	Internal consistency and construct validity of the concise scale were compared with the longer version .
RESULTS	Initially , 11 items were excluded on the basis of conceptual and empirical overlap with other items .
RESULTS	CFA indicated that the negative-control and negative-consequences dimensions could be combined , allowing us to exclude a further item from this dimension .
RESULTS	The 5-item timeline-cyclical dimension was also excluded , as it was less well-established conceptually and empirically than the other dimensions .
RESULTS	The final 17-item , 5-dimension model was consistent with the original conceptual model and fit the data well ( chi-sq = 1433.54 , df ( 109 ) , p < 0.01 , RMSEA = 0.04 , CFI = 0.97 , TLI = 0.96 ) .
CONCLUSIONS	The Brief-APQ ( B-APQ ) is a concise , multi-dimensional measure of ageing perceptions , which is psychometrically valid for use with the Irish population aged 50 + .
CONCLUSIONS	The concise version preserved the internal consistency and construct validity of the original .
CONCLUSIONS	Its brevity makes it particularly suitable for use with large-scale adult population surveys .
CONCLUSIONS	The psychometric analysis supports the application of the self-regulation model to ageing perceptions , but also the existence of distinct `` physical decline '' and `` ongoing development '' dimensions of perceptions .

###24646201
BACKGROUND	Organized screening based on Pap tests has substantially reduced deaths from cervical cancer in many countries , including Australia .
BACKGROUND	However , the impact of the program depends upon the degree to which women participate .
BACKGROUND	A new method of screening , testing for human papillomavirus ( HPV ) DNA to detect the virus that causes cervical cancer , has recently become available .
BACKGROUND	Because women can collect their own samples for this test at home , it has the potential to overcome some of the barriers to Pap tests .
BACKGROUND	The iPap trial will evaluate whether mailing an HPV self-sampling kit increases participation by never - and under-screened women within a cervical screening program .
METHODS	The iPap trial is a parallel randomized controlled , open label , trial .
METHODS	Participants will be Victorian women age 30-69 years , for whom there is either no record on the Victorian Cervical Cytology Registry ( VCCR ) of a Pap test ( never-screened ) or the last recorded Pap test was between five to fifteen years ago ( under-screened ) .
METHODS	Enrolment information from the Victorian Electoral Commission will be linked to the VCCR to determine the never-screened women .
METHODS	Variables that will be used for record linkage include full name , address and date of birth .
METHODS	Never - and under-screened women will be randomly allocated to either receive an invitation letter with an HPV self-sampling kit or a reminder letter to attend for a Pap test , which is standard practice for women overdue for a test in Victoria .
METHODS	All resources have been focus group tested .
METHODS	The primary outcome will be the proportion of women who participate , by returning an HPV self-sampling kit for women in the self-sampling arm , and notification of a Pap test result to the Registry for women in the Pap test arm at 3 and 6 months after mailout .
METHODS	The most important secondary outcome is the proportion of test-positive women who undergo further investigations at 6 and 12 months after mailout of results .
CONCLUSIONS	The iPap trial will provide strong evidence about whether HPV self-sampling could be used in Australia to improve participation in cervical screening for never-and under-screened women .
BACKGROUND	ANZCTR Identifier : ACTRN12613001104741 ; UTN : U1111-1148-3885 .

###24780934
BACKGROUND	eHealth interventions are effective for weight control and have the potential for broad reach .
BACKGROUND	Little is known about the use of interactive voice response ( IVR ) technology for self-monitoring in weight control interventions , particularly among populations disproportionately affected by obesity .
OBJECTIVE	This analysis sought to examine patterns and predictors of IVR self-monitoring adherence and the association between adherence and weight change among low-income black women enrolled in a weight gain prevention intervention .
METHODS	The Shape Program was a randomized controlled trial comparing a 12-month eHealth behavioral weight gain prevention intervention to usual care among overweight and obese black women in the primary care setting .
METHODS	Intervention participants ( n = 91 ) used IVR technology to self-monitor behavior change goals ( eg , no sugary drinks , 10,000 steps per day ) via weekly IVR calls .
METHODS	Weight data were collected in clinic at baseline , 6 , and 12 months .
METHODS	Self-monitoring data was stored in a study database and adherence was operationalized as the percent of weeks with a successful IVR call .
RESULTS	Over 12 months , the average IVR completion rate was 71.6 % ( SD 28.1 ) and 52 % ( 47/91 ) had an IVR completion rate 80 % .
RESULTS	At 12 months , IVR call completion was significantly correlated with weight loss ( r = -.22 ; P = .04 ) and participants with an IVR completion rate 80 % had significantly greater weight loss compared to those with an IVR completion rate < 80 % ( -1.97 kg , SE 0.67 vs 0.48 kg , SE 0.69 ; P = .01 ) .
RESULTS	Similar outcomes were found for change in body mass index ( BMI ; mean difference -0.94 kg , 95 % CI -1.64 to -0.24 ; P = .009 ) .
RESULTS	Older , more educated participants were more likely to achieve high IVR call completion .
RESULTS	Participants reported positive attitudes toward IVR self-monitoring .
CONCLUSIONS	Adherence to IVR self-monitoring was high among socioeconomically disadvantaged black women enrolled in a weight gain prevention intervention .
CONCLUSIONS	Higher adherence to IVR self-monitoring was also associated with greater weight change .
CONCLUSIONS	IVR is an effective and useful tool to promote self-monitoring and has the potential for widespread use and long-term sustainability .
BACKGROUND	Clinicaltrials.gov NCT00938535 ; http://www.clinicaltrials.gov/ct2/show/NCT00938535 .

###25439407
OBJECTIVE	To compare the clinical efficacy of co-induction with propofol-midazolam-ketamine with etomidate as the sole induction agent .
METHODS	Prospective , double-blinded , randomized controlled trial .
METHODS	Operating room of a university hospital .
METHODS	60 ASA physical status 1 and 2 patients scheduled for limited elective surgery requiring general anesthesia .
METHODS	Patients were randomized to two groups to receive etomidate 0.3 mg/kg ( single-drug group ) or propofol 0.6 mg/kg + ketamine 0.8 mg/kg + midazolam 0.06 mg/kg ( three-drug group ) .
METHODS	Hemodynamic responses ( systolic and diastolic blood pressure , and mean arterial pressure ) were examined at baseline and at one , three , and 5 minutes after tracheal intubation .
METHODS	Plasma catecholamine levels were measured at baseline , one , and 5 minutes after tracheal intubation .
RESULTS	Heart rate ( HR ) changes differed significantly between the two groups at three minutes ( P = 0.01 ) and 5 minutes ( P = 0.00 ) after tracheal intubation .
RESULTS	However , the HR increase in the three-drug group was in the acceptable range .
RESULTS	Percentage changes of epinephrine level differed between the two groups at 5 minutes after tracheal intubation ( P = 0.03 ) .
CONCLUSIONS	The higher norepinephrine/epinephrine ratio noted in the single-drug group may be implicated in lower adrenal sympathetic activity .
CONCLUSIONS	Propofol-midazolam-ketamine co-induction may be used instead of etomidate for anesthesia induction in patients with hemodynamic instability .

###24447343
BACKGROUND	Systemic inflammation beyond the skin may provide an explanation of the increased cardiovascular risk observed in psoriasis .
BACKGROUND	It was hypothesized that neutrophil-to-lymphocyte ratio ( NLR ) and platelet-to-lymphocyte ratio ( PLR ) are potential predictors of subclinical atherosclerosis measured by aortic velocity propagation ( AVP ) and carotid intima-media thickness ( CIMT ) in psoriasis .
METHODS	Fifty-one patients with psoriasis taking no antipsoriatic therapy and 37 age - and sex-matched healthy controls were prospectively enrolled .
METHODS	The Psoriasis Area and Severity Index ( PASI ) was calculated .
METHODS	Complete blood counts were obtained .
METHODS	Measurements of AVP and CIMT were performed .
RESULTS	The baseline clinical and demographic features , and white blood cell , platelet , neutrophil , lymphocyte , monocyte , and PLR were similar in both groups .
RESULTS	NLR and high-sensitivity C-reactive protein ( hs-CRP ) were higher in the psoriasis group than the control group ( P = 0.001 , P < 0.001 ; respectively ) .
RESULTS	The psoriasis group had lower AVP and higher CIMT values than those of controls ( AVP : 48.918.1 vs. 64.314.5 cm/sec ; P < 0.001 , CIMT : 0.840.29 vs. 0.630.27 mm ; P = 0.001 , respectively ) .
RESULTS	PASI was positively correlated with NLR and hs-CRP ( r = 0.423 , P = 0.002 ; r = 0.315 , P = 0.024 , respectively ) .
RESULTS	There was an inverse association between AVP and CIMT ( r = -0.749 , P < 0.001 ) .
RESULTS	Binary logistic regression analysis demonstrated that NLR was the only variable able to predict lower AVP ( 41cm/sec ) and higher CIMT ( > 0.9 mm ) values ( P = 0.024 and 0.023 ; respectively ) .
CONCLUSIONS	NLR is potentially an unrecognized predictor of subclinical atherosclerosis in patients with psoriasis .
CONCLUSIONS	Future studies assessing the prognostic significance of NLR on cardiovascular event rates in psoriasis patients would be of great interest .

###24867312
OBJECTIVE	To analyze , using in vivo laser scanning confocal microscopy ( LSCM ) , the conjunctival features in glaucomatous patients receiving prostaglandin analogues ( PGA ) .
METHODS	Eighty eyes of 80 consecutive glaucomatous patients naive for therapy were enrolled ; 30 eyes of 30 healthy subjects served as a control .
METHODS	Patients were randomized to : preservative-free ( PF ) and preserved latanoprost ( groups 1 and 2 , respectively ) , PF and preserved timolol ( groups 3 and 4 ) , and controls to vehicle of latanoprost or physiological buffered saline solution ( groups 5 and 6 ) .
METHODS	All subjects underwent LSCM of bulbar conjunctiva at baseline and 3 months after initiating therapy .
METHODS	The main outcomes were : mean density ( MMD : cysts/mm ( 2 ) ) and mean area ( MMA : cysts/mm ( 2 ) ) of epithelial microcysts .
METHODS	The relations between MMA and MMD with intraocular pressure ( IOP ) , age , and mean defect ( MD ) , were analyzed .
RESULTS	At baseline , microcysts were found in all subjects .
RESULTS	At month three , MMD did not change in all groups ( p > 0.05 ) .
RESULTS	MMA significantly increased only in group 1 from 2,158.81524.09 to 3,877.77867.31 , and in group 2 from 2,019.71541.03 to 5,560.391,176.14 , with values significantly higher in group 2 ( p < 0.001 ) .
RESULTS	Significant relations were not found between MMD and MMA with IOP , MD , and age ( p > 0.05 ) .
CONCLUSIONS	PGA increased MMA in therapy-naive glaucomatous patients , indicating a possible enhancement of the trans-conjunctival aqueous humor outflow .
CONCLUSIONS	Therefore , conjunctiva seems an additional target tissue to evaluate the hydrodynamic pathways in glaucoma and modifications induced by medical therapy .

###25103125
BACKGROUND	Healthcare providers play an important role in encouraging healthy behaviors and improving health-related quality of life ( HRQoL ) .
BACKGROUND	They are most effective when they partner with informed , engaged patients .
OBJECTIVE	To examine the impact of a new health-information technology intervention ( FAST-Feedback ) that provides patients with immediate , personalized , guideline-based feedback regarding tobacco use , physical activity , and HRQoL , and encourages patients to initiate discussions regarding these topics with their primary care physician .
METHODS	A pilot , randomized controlled trial clustered by resident physician , with patients as the unit of analysis .
METHODS	Resident physicians and their out-patients in a single academic health center between May and October 2011 .
METHODS	Patients received ( intervention ) or did not receive ( control ) FAST-Feedback prior to the clinical encounter .
METHODS	Primary outcomes were patient reports of initiating any discussions regarding tobacco use , physical activity , and HRQoL .
METHODS	Subgroup analyses examined patient reports of discussions regarding tobacco use , physical activity , and HRQoL , respectively .
RESULTS	Thirty of the 36 eligible resident physicians ( 83 % ) agreed to participate ; 173 of their 415 eligible patients ( 42 % ) expressed interest in the study and 99 ( 24 % ) consented to participate .
RESULTS	Compared to controls , a higher percentage of intervention patients reported initiating any discussion with their resident physician , although this difference was not statistically significant ( 40 % vs. 27 % ; p = 0.12 ) .
RESULTS	For subgroup analyses regarding specific topics of discussion , patients in the intervention group reported initiating more discussions regarding mental HRQoL than controls ( 23 % vs. 0 % ; p = 0.02 ) .
RESULTS	There was no difference in patient reports of initiating discussions regarding smoking , physical activity or physical HRQoL .
CONCLUSIONS	Providing patients with immediate , personalized , guideline-based feedback prior to the clinical encounter can increase patient-initiated discussions regarding mental HRQoL .
CONCLUSIONS	Future work should test FAST-Feedback in a larger population and evaluate the impact on tobacco cessation , increased physical activity , and improvements in HRQoL .

###25574939
BACKGROUND	Rheumatoid arthritis ( RA ) is chronic systematic disease that affects people during the most productive period of their lives .
BACKGROUND	Web-based health interventions have been effective in many studies ; however , there is little evidence and few studies showing the effectiveness of online social support and especially gamification on patients ' behavioral and health outcomes .
OBJECTIVE	The aim of this study was to look into the effects of a Web-based intervention that included online social support features and gamification on physical activity , health care utilization , medication overuse , empowerment , and RA knowledge of RA patients .
OBJECTIVE	The effect of gamification on website use was also investigated .
METHODS	We conducted a 5-arm parallel randomized controlled trial for RA patients in Ticino ( Italian-speaking part of Switzerland ) .
METHODS	A total of 157 patients were recruited through brochures left with physicians and were randomly allocated to 1 of 4 experimental conditions with different types of access to online social support and gamification features and a control group that had no access to the website .
METHODS	Data were collected at 3 time points through questionnaires at baseline , posttest 2 months later , and at follow-up after another 2 months .
METHODS	Primary outcomes were physical activity , health care utilization , and medication overuse ; secondary outcomes included empowerment and RA knowledge .
METHODS	All outcomes were self-reported .
METHODS	Intention-to-treat analysis was followed and multilevel linear mixed models were used to study the change of outcomes over time .
RESULTS	The best-fit multilevel models ( growth curve models ) that described the change in the primary outcomes over the course of the intervention included time and empowerment as time-variant predictors .
RESULTS	The growth curve analyses of experimental conditions were compared to the control group .
RESULTS	Physical activity increased over time for patients having access to social support sections plus gaming ( unstandardized beta coefficient [ B ] = 3.39 , P = .02 ) .
RESULTS	Health care utilization showed a significant decrease for patients accessing social support features ( B = -0.41 , P = .01 ) and patients accessing both social support features and gaming ( B = -0.33 , P = .03 ) .
RESULTS	Patients who had access to either social support sections or the gaming experience of the website gained more empowerment ( B = 2.59 , P = .03 ; B = 2.29 , P = .05 ; respectively ) .
RESULTS	Patients who were offered a gamified experience used the website more often than the ones without gaming ( t91 = -2.41 , P = .02 ; U = 812 , P = .02 ) .
CONCLUSIONS	The Web-based intervention had a positive impact ( more desirable outcomes ) on intervention groups compared to the control group .
CONCLUSIONS	Social support sections on the website decreased health care utilization and medication overuse and increased empowerment .
CONCLUSIONS	Gamification alone or with social support increased physical activity and empowerment and decreased health care utilization .
CONCLUSIONS	This study provides evidence demonstrating the potential positive effect of gamification and online social support on health and behavioral outcomes .
BACKGROUND	International Standard Randomized Controlled Trial Number ( ISRCTN ) : 57366516 ; http://www.controlled-trials .
BACKGROUND	com/ISRCTN57366516 ( Archived by webcite at http://www.webcitation.org/6PBvvAvvV ) .

###24452083
OBJECTIVE	Assessment of flow-mediated dilation ( FMD ) and nitroglycerin-mediated dilation ( NMD ) in the brachial artery by a new device ( UNEXEF18G ) has been reported to be excellent for evaluating endothelial function , and sympathetic overdrive can accelerate the atherosclerotic process .
OBJECTIVE	The purpose of this study was to investigate and confirm whether anti-sympathetic beta-blocking action can enhance the pleiotropic effects of statins .
METHODS	FMD and NMD were measured using the UNEXEF18G before and after 4-week treatment of rosuvastatin ( 5 mg/day ) with or without atenolol ( 25 mg/day ) in 44 hypercholesterolemic patients ( 708 years old , LDL-C > 140 mg/dL ) with hypertension .
METHODS	Patients were randomly allocated to two treatment arms : rosuvastatin alone ( R-group , N. = 22 ) and rosuvastatin with atenolol ( RA-group , N. = 22 ) .
RESULTS	Baseline FMD was not different between the two treatment arms , and both groups showed improvement in FMD ( R-group , 3.481.9 % to 4.652.41 % , P < 0.05 ; RA-group , 3.421.48 % to 5.461.79 % , P < 0.05 ) , while there were no differences in NMD .
RESULTS	The effects on lipid profiles were identical in the two groups .
RESULTS	In addition , FMD improvement was greater in the RA-group than in the R-group ( change 2.151.29 % vs. 1.161.15 % , P < 0.05 ) .
CONCLUSIONS	Beta-blockade enhances the pleiotropic effects of statins on endothelial function .
CONCLUSIONS	The mechanism should be confirmed by further studies .

###24901365
OBJECTIVE	Women-initiated HIV-prevention products are urgently needed .
OBJECTIVE	To address this need , a trial was conducted to assess the safety and pharmacokinetics of a silicone elastomer matrix vaginal ring containing 25 mg of the antiretroviral drug dapivirine when used continuously for 28 consecutive days .
METHODS	A double-blind , randomized , placebo-controlled trial was conducted in 16 healthy , HIV-negative women , 18-40 years of age , who were randomized 1:1 to use either the active or matching placebo ring for 28 days .
METHODS	Participants were followed during and for 28 days after ring use for safety and pharmacokinetic evaluations .
RESULTS	The dapivirine vaginal ring was safe and well tolerated with no differences in safety endpoints between the active and placebo ring .
RESULTS	The concentration-time plots of dapivirine in vaginal fluid were indicative of a sustained release of dapivirine over the 28 days of use .
RESULTS	Dapivirine vaginal fluid concentrations were highest near the ring , followed by the cervix and introtus ( mean Cmax of 80 , 67 and 31 g/g , respectively ) .
RESULTS	Vaginal fluid concentrations of dapivirine on the day of ring removal ( day 28 ) at all three collection sites exceeded by more than 3900-fold the IC99 for dapivirine in a tissue explant infection model .
RESULTS	Plasma dapivirine concentrations were low ( < 1 ng/ml ) and remained well below those observed at the maximum tolerated dose for oral treatment ( mean Cmax of 2286 ng/ml ) .
CONCLUSIONS	The dapivirine vaginal ring has a safety and pharmacokinetic profile that supports its use as a sustained-release topical microbicide for HIV-1 prevention in women .

###25121991
BACKGROUND	Collaborative care is an effective treatment for the management of depression but evidence on its cost-effectiveness in the UK is lacking .
OBJECTIVE	To assess the cost-effectiveness of collaborative care in a UK primary care setting .
METHODS	An economic evaluation alongside a multi-centre cluster randomised controlled trial comparing collaborative care with usual primary care for adults with depression ( n = 581 ) .
METHODS	Costs , quality-adjusted life-years ( QALYs ) , and incremental cost-effectiveness ratios ( ICER ) were calculated over a 12-month follow-up , from the perspective of the UK National Health Service and Personal Social Services ( i.e. Third Party Payer ) .
METHODS	Sensitivity analyses are reported , and uncertainty is presented using the cost-effectiveness acceptability curve ( CEAC ) and the cost-effectiveness plane .
RESULTS	The collaborative care intervention had a mean cost of 272.50 per participant .
RESULTS	Health and social care service use , excluding collaborative care , indicated a similar profile of resource use between collaborative care and usual care participants .
RESULTS	Collaborative care offered a mean incremental gain of 0.02 ( 95 % CI : -0.02 , 0.06 ) quality-adjusted life-years over 12 months , at a mean incremental cost of 270.72 ( 95 % CI : -202.98 , 886.04 ) , and resulted in an estimated mean cost per QALY of 14,248 .
RESULTS	Where costs associated with informal care are considered in sensitivity analyses collaborative care is expected to be less costly and more effective , thereby dominating treatment as usual .
CONCLUSIONS	Collaborative care offers health gains at a relatively low cost , and is cost-effective compared with usual care against a decision-maker willingness to pay threshold of 20,000 per QALY gained .
CONCLUSIONS	Results here support the commissioning of collaborative care in a UK primary care setting .

###25080462
BACKGROUND	Benefits of recombinant human growth hormone ( rhGH ) alone or combined with glutamine in patients with intestinal failure because of short-bowel syndrome remain controversial .
OBJECTIVE	We explored effects of rhGH on whole-body protein metabolism in patients with short-bowel syndrome with intestinal failure ( SBS-IF ) to gain insight into its mechanism of action .
METHODS	Eight stable hyperphagic patients with severe SBS-IF received , in a double-blind , randomized crossover study , low-dose rhGH ( 0.05 mg kg d ) and a placebo for two 3-wk periods .
METHODS	Leucine and glutamine kinetics under fasting and fed conditions , fat-free mass ( FFM ) , and serum insulin were determined on the final day of each treatment .
RESULTS	rhGH increased FFM and nonoxidative leucine disposal ( NOLD ; an index of protein synthesis ) ( P < 0.02 ) , whereas FFM and NOLD were correlated in the fed state ( r = 0.81 , P = 0.015 ) .
RESULTS	With rhGH administration , leucine release from protein breakdown ( an index of proteolysis ) decreased in the fed compared with fasting states ( P = 0.012 ) , which was not observed with the placebo .
RESULTS	However , the fast-to-fed difference in leucine release from protein breakdown was not significantly different between rhGH and placebo ( P = 0.093 ) .
RESULTS	With rhGH , the intestinal absorption of leucine and glutamine increased ( P = 0.036 ) and correlated with serum insulin ( r = 0.91 , P = 0.002 ) .
RESULTS	rhGH increased glutamine de novo synthesis ( P < 0.02 ) and plasma concentrations ( P < 0.03 ) in both fasting and fed states .
CONCLUSIONS	In SBS-IF patients , feeding fails to decrease proteolysis in contrast to what is physiologically observed in healthy subjects .
CONCLUSIONS	rhGH enhances FFM through the stimulation of protein synthesis and might decrease proteolysis in response to feeding .
CONCLUSIONS	Improvements in de novo synthesis and intestinal absorption increase glutamine availability over the physiologic range , suggesting that beneficial effects of rhGH in hyperphagic patients might be achieved without glutamine supplementation .

###24712653
BACKGROUND	Preliminary research shows ginger may be an effective adjuvant treatment for chemotherapy-induced nausea and vomiting but significant limitations need to be addressed before recommendations for clinical practice can be made .
METHODS	In a double-blinded randomised-controlled trial , chemotherapy-nave patients will be randomly allocated to receive either 1.2 g of a standardised ginger extract or placebo per day .
METHODS	The study medication will be administrated as an adjuvant treatment to standard anti-emetic therapy and will be divided into four capsules per day , to be consumed approximately every 4hours ( 300mg per capsule administered q.i.d ) for five days during the first three cycles of chemotherapy .
METHODS	Acute , delayed , and anticipatory symptoms of nausea and vomiting will be assessed over this time frame using a valid and reliable questionnaire , with nausea symptoms being the primary outcome .
METHODS	Quality of life , nutritional status , adverse effects , patient adherence , cancer-related fatigue , and CINV-specific prognostic factors will also be assessed .
CONCLUSIONS	Previous trials in this area have noted limitations .
CONCLUSIONS	These include the inconsistent use of standardized ginger formulations and valid questionnaires , lack of control for anticipatory nausea and prognostic factors that may influence individual CINV response , and the use of suboptimal dosing regimens .
CONCLUSIONS	This trial is the first to address these issues by incorporating multiple unique additions to the study design including controlling for CINV-specific prognostic factors by recruiting only chemotherapy-nave patients , implementing a dosing schedule consistent with the pharmacokinetics of oral ginger supplements , and independently analysing ginger supplements before and after recruitment to ensure potency .
CONCLUSIONS	Our trial will also be the first to assess the effect of ginger supplementation on cancer-related fatigue and nutritional status .
CONCLUSIONS	Chemotherapy-induced nausea and vomiting are distressing symptoms experienced by oncology patients ; this trial will address the significant limitations within the current literature and in doing so , will investigate the effect of ginger supplementation as an adjuvant treatment in modulating nausea and vomiting symptoms .
BACKGROUND	ANZCTR.org.au Identifier : ACTRN12613000120774 .

###24560764
OBJECTIVE	ANZMTG 01.07 WBRTMel is a phase 3 randomized trial to address the role of whole brain radiation therapy ( WBRT ) after local treatment of 1-3 melanoma brain metastases .
OBJECTIVE	Modern radiation therapy technologies can now conformally spare the hippocampus during WBRT and therefore potentially reduce the risk of neurocognitive deficit .
OBJECTIVE	The aims of this study were to report the prevalence of melanoma metastases within the hippocampal sparing region and to identify variables that correlate with the presence of metastases within the hippocampal sparing region .
METHODS	The pre-local treatment MRI scans of 77 eligible WBRTMel patients were used to contour the individual metastasis and the hippocampus .
METHODS	The volume , location and closest distance of each metastasis to the hippocampus were recorded .
METHODS	Binary logistic regression was performed to assess the influence of factors on the location of a metastasis within 5mm of the hippocampus .
RESULTS	The median age was 61 and 66 % were male .
RESULTS	The distribution of the 115 metastases was frontal ( 50 , 43.5 % ) , parietal ( 23 , 20.0 % ) , temporal ( 13 , 11.2 % ) , occipital ( 18 , 15.7 % ) , cerebellum ( 10 , 8.6 % ) and pineal gland ( 1 , 1.0 % ) .
RESULTS	The median aggregate volume of the metastasis was 3516mm ( 3 ) .
RESULTS	None of the metastases were within the hippocampus .
RESULTS	Four patients ( 5.2 % ) had metastases within 5mm of the hippocampus .
RESULTS	The median distance from metastasis to the nearest hippocampus was 37.2 mm .
RESULTS	Only the total volume of metastases was a significant predictor for the risk of a metastasis within the hippocampal sparing region ( OR 1.071 , 95 % CI : 1.003-1 .144 , p = 0.040 ) .
CONCLUSIONS	This study confirmed a low incidence of melanoma metastasis in the hippocampal sparing region at diagnosis .
CONCLUSIONS	Given the lack of randomized data on the safety and benefit of hippocampal sparing WBRT , the current WBRTMel trial provides the opportunity to explore the feasibility of this technique .

###25367823
OBJECTIVE	To evaluate if a feasible , low-cost intervention could decrease the percentage of women gaining weight above the Institute of Medicine ( IOM ) recommendations on gestational weight gain ( GWG ) compared with standard maternity care .
METHODS	A randomised controlled interventional design .
METHODS	Antenatal clinics ( n = 14 ) in rebro county , Sweden , participated .
METHODS	Healthy women with a body mass index ( BMI ) 19 kg/m ( 2 ) , age 18 years and adequate knowledge of Swedish language who signed in for maternity care at 16 weeks of gestation .
METHODS	Standard care was compared with a composite intervention consisting of education on recommended GWG according to IOM , application of personalised weight graph , formalised prescription of exercise and regular monitoring of GWG at every antenatal visit .
RESULTS	The proportion of women gaining weight above IOM guidelines ( 1990 ) and mean GWG ( kg ) was compared between groups .
RESULTS	In all , 445 women were randomised and 374 women remained for analysis after delivery .
RESULTS	A majority of the women analysed were normal weight ( 72 % ) .
RESULTS	The intervention reduced the proportion of women who exceeded the IOM guidelines ( 41.1 % versus 50.0 % ) .
RESULTS	The reduction was , however , not statistically significant ( P = 0.086 ) .
RESULTS	Mean GWG was significantly lower among women receiving the intervention , 14.2 kg ( SD 4.4 ) versus 15.3 kg ( SD 5.4 ) in the standard care group ( P = 0.029 ) .
CONCLUSIONS	The low-cost intervention programme tested did significantly reduce the mean GWG but the proportion of women who exceeded the IOM recommendations for GWG was not significantly lower .
CONCLUSIONS	ClinicalTrials.gov Id NCT00451425 http://clinicaltrials.gov .

###25264862
OBJECTIVE	To evaluate the effectiveness of the Play and Language for Autistic Youngsters ( PLAY ) Project Home Consultation model , in combination with usual community services ( CS ) , to improve parent-child interaction , child development , and autism symptomatology in young children with autism spectrum disorders ( ASDs ) compared with CS only .
METHODS	Children ( N = 128 ) with autism or PDD-NOS ( DSM-4 criteria ) aged 2 years 8 months to 5 years 11 months and recruited from 5 disability agencies in 4 US states were randomized in two 1-year cohorts .
METHODS	Using videotape and written feedback within a developmental framework , PLAY consultants coached caregivers monthly for 12 months to improve caregiver-child interaction .
METHODS	CS included speech/language and occupational therapy and public education services .
METHODS	Primary outcomes included change in parent-child interactions , language and development , and autism-related diagnostic category/symptoms .
METHODS	Secondary outcomes included parent stress and depression and home consultant fidelity .
METHODS	Data were collected pre - and post-intervention .
RESULTS	Using intent-to-treat analysis ( ITT ) , large treatment effects were evident for parent and child interactional behaviors on the Maternal and Child Behavior Rating Scales .
RESULTS	Child language and developmental quotient did not differ over time by group , although functional development improved significantly .
RESULTS	PLAY children improved in diagnostic categories on the Autism Diagnostic Observation Schedule ( ADOS ) .
RESULTS	PLAY caregivers ' stress did not increase , and depressive symptomatology decreased .
RESULTS	Home consultants administered the intervention with fidelity .
CONCLUSIONS	PLAY intervention demonstrated substantial changes in parent-child interaction without increasing parents ' stress/depression .
CONCLUSIONS	ADOS findings must be interpreted cautiously because results do not align with clinical experience .
CONCLUSIONS	PLAY offers communities a relatively inexpensive effective intervention for children with ASD and their parents .

###24767232
OBJECTIVE	To assess the long-term effects of positive airway pressure ( PAP ) therapy on the ocular surface and eyelid in patients with obstructive sleep apnea hypopnea syndrome ( OSAHS ) .
METHODS	Single-centred , prospective , and double-blinded study .
METHODS	Fifty-one patients with OSAHS .
METHODS	Fifty-one patients with OSAHS were treated with PAP for a period of 18 months .
METHODS	The pre - and post-PAP values for eye examination scores ( presence of floppy eyelid syndrome [ FES ] , results of the Ocular Surface Disease Index [ OSDI ] questionnaire , Schirmer I test , tear film break-up time [ TBUT ] values , and corneal staining stages ) were compared .
RESULTS	Based on the apnea-hypopnea index , 17 patients were followed with moderate and 34 patients were followed with severe OSAHS .
RESULTS	The presence of FES before and after PAP was 56.9 % and 74.5 % ( p < 0.01 ) .
RESULTS	FES stage was determined as 1.41 0.98 before PAP and 0.78 0.78 after PAP ( p < 0.01 ) .
RESULTS	Pre-PAP and post-PAP OSDI results were 47.79 21.04 and 42.17 19.97 , respectively ( p < 0.01 ) .
RESULTS	Schirmer values before and after PAP were 7.23 1.95 and 8.49 1.79 mm , respectively ( p < 0.01 ) .
RESULTS	TBUT values before and after PAP were 7.11 1.82 and 8.68 1.76 seconds , respectively ( p < 0.01 ) .
RESULTS	Scores of the corneal staining stages before and after PAP were 1.05 0.75 and 0.68 0.54 , respectively ( p < 0.01 ) .
CONCLUSIONS	OSAHS is associated with low Schirmer and TBUT values , and high scores in OSDI questionnaire , and high corneal staining stage .
CONCLUSIONS	An appropriate PAP therapy helps to relieve both the systemic findings and the ocular surface problems most likely by providing a return to normal sleep patterns .
CONCLUSIONS	We believe that long-term ( at least 1 year ) use of PAP improves the clinical picture of FES and can overcome the problem of ocular irritation that is encountered in the early stage of PAP .

###25566706
BACKGROUND	Coagulopathy is a major issue in children undergoing high-risk pediatric cardiac surgery .
BACKGROUND	Use of anti-fibrinolytics is well documented in adults , but recently there are questions raised about safety and effectiveness of their use on routine use .
BACKGROUND	Tranexamic acid is a potent anti-fibrinolytic , but its role is not fully understood in children .
BACKGROUND	This study aims to study the benefits tranexamic acid in controlling postoperative bleeding in pediatric cardiac surgical patients .
RESULTS	Fifty consecutive children who underwent cardiac surgery were randomized prospectively to receive either aprotinin ( Group A ; n = 24 ) or tranexamic acid ( Group B ; n = 26 ) from September 2009 to February 2010 were studied .
RESULTS	Primary end points were early mortality , postoperative drainage , reoperation for bleeding and complications .
RESULTS	Mean age and body weight was smaller in Group A ( Age : 48.55 vs. 64.73 months ; weight 10.75 vs. 14.80 kg ) respectively .
RESULTS	Group A had more cyanotic heart disease than Group B ( 87.5 % vs. 76.92 % ) .
RESULTS	Mean cardiopulmonary bypass time ( 144.33 vs. 84.34 min ) and aortic cross-clamp time ( 78.5 vs. 41.46 min ) were significantly higher in group A.
RESULTS	While the blood and products usage was significantly higher in Group A , there was no difference in indexed postoperative drainage in first 4 , 8 and 12 h and postoperative coagulation parameters .
RESULTS	Mean C-reactive protein was less in Group A than B and renal dysfunction was seen more in Group A ( 25 % vs. 7.6 % ) .
RESULTS	Mortality in Group A was 16.66 % and 7.6 % in Group B.
CONCLUSIONS	Anti-fibrinolytics have a definitive role in high-risk children who undergo open-heart surgery .
CONCLUSIONS	Tranexamic acid is as equally effective as aprotinin with no additional increase in morbidity or mortality .

###24262503
OBJECTIVE	An open-label , multicenter , randomized phase II trial was conducted from July 1 , 2005 to March 29 , 2011 to compare two protocols for treating children with frequently relapsing nephrotic syndrome using microemulsified cyclosporine .
METHODS	Ninety-three children with frequently relapsing nephrotic syndrome were randomly assigned to group A ( n = 46 ) or group B ( n = 47 ) .
METHODS	In both groups , the 2-hour postdose cyclosporine level was monitored .
METHODS	For group A , the cyclosporine target was set to 600-700 ng/ml for the first 6 months and 450-550 ng/ml for the next 18 months ; for group B , it was set to 450-550 ng/ml for the first 6 months and 300-400 ng/ml for the next 18 months .
METHODS	The primary end point was the sustained remission rate .
METHODS	At the end of the study , if there was no difference in safety profile between the two groups and the sustained remission rate in group A was superior to group B with a decision threshold of 8 % , then the regimen for group A would be determined the better treatment .
RESULTS	Eight children from an ineligible institution , where cyclosporine levels were not measured , were excluded from all analyses .
RESULTS	At 24 months , the sustained remission rate was nonsignificantly higher in group A ( n = 43 ) than group B ( n = 42 ; 64.4 % versus 50.0 % ; hazard ratio , 0.57 ; 95 % confidence interval , 0.29 to 1.11 ; P = 0.09 ) , and the progression-free survival rate was significantly higher ( 88.1 % versus 68.4 % ; hazard ratio , 0.33 ; 95 % confidence interval , 0.12 to 0.94 ; P = 0.03 ) .
RESULTS	The relapse rate was significantly lower in group A than group B ( 0.41 versus 0.95 times/person-year ; hazard ratio , 0.43 ; 95 % confidence interval , 0.19 to 0.84 ; P = 0.02 ) .
RESULTS	The rate and severity of adverse events were similar in both treatment groups .
CONCLUSIONS	The sustained remission rate was not significantly different between the two treatment groups , but the regimen with the higher 2-hour postdose cyclosporine level target improved progression-free survival and reduced the relapse rate .

###24835127
OBJECTIVE	To compare the clinical usefulness of constant rate infusion ( CRI ) protocols of romifidine with or without butorphanol for sedation of horses .
METHODS	Prospective ` blinded ' controlled trial using block randomization .
METHODS	Forty healthy Freiberger stallions .
METHODS	The horses received either intravenous ( IV ) romifidine ( loading dose : 80gkg ( -1 ) ; infusion : 30gkg ( -1 ) hour ( -1 ) ) ( treatment R , n = 20 ) or romifidine combined with butorphanol ( romifidine loading : 80gkg ( -1 ) ; infusion : 29gkg ( -1 ) hour ( -1 ) , and butorphanol loading : 18gkg ( -1 ) ; infusion : 25gkg ( -1 ) hour ( -1 ) ) ( treatment RB , n = 20 ) .
METHODS	Twenty-one horses underwent dentistry and ophthalmic procedures , while 19 horses underwent only ophthalmologic procedure and buccal examination .
METHODS	During the procedure , physiologic parameters and occurrence of head/muzzle shaking or twitching and forward movement were recorded .
METHODS	Whenever sedation was insufficient , additional romifidine ( 20gkg ( -1 ) ) was administered IV .
METHODS	Recovery time was evaluated by assessing head height above ground .
METHODS	At the end of the procedure , overall quality of sedation for the procedure was scored by the dentist and anaesthetist using a visual analogue scale .
METHODS	Statistical analyses used two-way anova or linear mixed models as relevant .
RESULTS	Sedation quality scores as assessed by the anaesthetist were R : median 7.55 , range : 4.9-9 .0 cm , RB : 8.8 , 4.7-10 .0 cm , and by the dentist R : 6.6 , 3.0-8 .2 cm , RB : 7.9 , 6.6-8 .8 cm .
RESULTS	Horses receiving RB showed clinically more effective sedation as demonstrated by fewer poor scores and a tendency to reduced additional drug requirements .
RESULTS	More horses showed forward movement and head shaking in treatment RB than treatment R. Three horses ( two RB , one R ) had symptoms of colic following sedation .
CONCLUSIONS	The described protocols provide effective sedation under clinical conditions but for dentistry procedures , the addition of butorphanol is advantageous .

###25316464
OBJECTIVE	To evaluate the effects of systemic doxycycline on clinical and microbiological parameters of diabetic subjects with chronic periodontitis .
METHODS	This 9-month multi-center , randomized , parallel , single-blinded study was conducted from different hospitals in Riyadh , Saudi Arabia between April 2010 and December 2010 .
METHODS	A total of 76 diabetic subjects with chronic periodontitis were randomized into 2 groups : control group ( CG ) received only scaling and root planing ( SRP ) , and the treatment group ( TG ) receiving systemic doxycycline during the reevaluation visit 45 days after the completion of SRP .
METHODS	Probing pocket depth , clinical attachment level , gingival index , plaque index , and bleeding on probing were collected at baseline , 45 days after SRP , and one , 3 , and 6 months after the use of systemic doxycycline .
METHODS	Microbiological analysis comprised the detection of Tannerella forsythia ( Tf ) , Aggregatibacter actinomycetemcomitans ( Aa ) , Porphyromonas gingivalis ( Pg ) , and Prevotella intermedia ( Pi ) by polymerase chain reaction method .
RESULTS	Sixty-eight ( 33 CG and 35 TG ) subjects completed the study .
RESULTS	Greater reduction in the population of Tf , Pg , and Pi were observed in TG compared with CG in the first month after the administration of systemic doxycycline .
RESULTS	The TG showed a significant improvement in gingival index scores compared with the CG ( p < 0.05 ) by the end of the first and 6 months after the administration of doxycycline .
CONCLUSIONS	Adjunct systemic doxycycline can be associated with a reduction of Tf , Pg , and Pi in the first month after the administration of doxycycline with an improvement in the GI .

###24332416
OBJECTIVE	This study sought to evaluate the impact of anatomic and procedural variables on the outcome of the unprotected left main coronary artery ( uLMCA ) itself after drug-eluting stent ( DES ) implantation .
BACKGROUND	There is a controversial debate regarding when and how to perform percutaneous coronary intervention ( PCI ) for an uLMCA stenosis .
METHODS	This analysis is based on a randomized study of 607 patients undergoing PCI for uLMCA , randomized 1:1 to receive paclitaxel - or sirolimus-eluting stents .
METHODS	We evaluated the impact of the SYNTAX score , uLMCA anatomy , and stenting technique on in-stent restenosis ( ISR ) , target lesion revascularization ( TLR ) , and the 3-year outcomes .
RESULTS	The 3-year cardiac mortality rate was 5.8 % ; 235 ( 39 % ) patients had a true bifurcation lesion ( TBL ) , and the median SYNTAX score was 27 .
RESULTS	TBL was associated with a higher need for multiple stents ( 72 % vs. 37 % , p < 0.001 ) .
RESULTS	TBL was a significant predictor of ISR ( 23 % vs. 14 % , p = 0.008 ) and for TLR ( 18 % vs. 9 % , p < 0.001 ) .
RESULTS	The need for multiple stents was a predictor of ISR ( 22 % vs. 13 % , p = 0.005 ) and for TLR ( 16 % vs. 9 % , p = 0.005 ) .
RESULTS	Culotte stenting showed better results compared with T-stenting for ISR ( 21 % vs. 56 % , p = 0.02 ) and for TLR ( 15 % vs. 56 % , p < 0.001 ) .
RESULTS	We observed a significant association between uLMCA-TLR and SYNTAX scores ( 9.2 % for scores 22 , 14.9 % for scores 23 to 32 , and 13.0 % for scores 33 , p = 0.008 ) .
CONCLUSIONS	PCI of uLMCA lesions with DES is safe and effective out to 3 years .
CONCLUSIONS	TBL and multiple stents were independent predictors for ISR .
CONCLUSIONS	In the multivariate analysis , independent predictors for TLR were TBL , age , and EuroSCORE ( European System for Cardiac Operative Risk Evaluation ) .
CONCLUSIONS	( Drug-Eluting-Stents for Unprotected Left Main Stem Disease [ ISAR-LEFT-MAIN ] ; NCT00133237 ) .

###25841542
OBJECTIVE	To evaluate the lipid-altering efficacy and safety of ezetimibe monotherapy in young children with heterozygous familial hypercholesterolemia ( HeFH ) or nonfamilial hypercholesterolemia ( nonFH ) .
METHODS	One hundred thirty-eight children 6-10 years of age with diagnosed HeFH or clinically important nonFH ( low-density lipoprotein cholesterol [ LDL-C ] 160 mg/dL [ 4.1 mmol/L ] ) were enrolled into a multicenter , 12-week , randomized , double-blind , placebo-controlled study .
METHODS	Following screening/drug washout and a 5-week single-blind placebo-run-in with diet stabilization , subjects were randomized 2:1 to daily ezetimibe 10 mg ( n = 93 ) or placebo ( n = 45 ) for 12 weeks .
METHODS	Lipid-altering efficacy and safety were assessed in all treated patients .
RESULTS	Overall , mean age was 8.3 years , 57 % were girls , 80 % were white , mean baseline LDL-C was 228 mg/dL ( 5.9 mmol/L ) , and 91 % had HeFH .
RESULTS	After 12 weeks , ezetimibe significantly reduced LDL-C by 27 % after adjustment for placebo ( P < .001 ) and produced significant reductions in total cholesterol ( 21 % ) , nonhigh-density lipoprotein cholesterol ( 26 % ) , and apolipoprotein B ( 20 % ) ( P < .001 for all ) .
RESULTS	LDL-C lowering response in sex , race , baseline lipids , and HeFH/nonFH subgroups was generally consistent with overall study results .
RESULTS	Ezetimibe was well tolerated , with a safety profile similar to studies in older children , adolescents , and adults .
CONCLUSIONS	Ezetimibe monotherapy produced clinically relevant reductions in LDL-C and other key lipid variables in young children with primary HeFH or clinically important nonFH , with a favorable safety/tolerability profile .
BACKGROUND	ClinicalTrials.gov : NCT00867165 .

###25305374
OBJECTIVE	To examine if 2 weekly sessions of supervised progressive resistance training ( PRT ) in combination with 5 weekly sessions of unsupervised home-based exercise is more effective than 7 weekly sessions of unsupervised home-based exercise in improving leg-extension power of the operated leg 10 weeks after total hip replacement ( THR ) in patients with lower pre-operative function .
METHODS	A total of 73 patients scheduled for THR were randomised ( 1:1 ) to intervention group ( IG , home based exercise 5 days/week and PRT 2 days/week ) or control group ( CG , home based exercise 7 days/week ) .
METHODS	The primary endpoint was change in leg extension power at 10 week follow up .
METHODS	Secondary outcomes were isometric hip muscle strength , sit-to-stand test , stair climb test , 20 m walking speed and patient-reported outcome ( HOOS ) .
RESULTS	Sixty-two completed the trial ( 85 % ) .
RESULTS	Leg extension power increased from baseline to the 10 week follow up in both groups ; mean [ 95 % CI ] IG : 0.29 [ 0.13 ; 0.45 ] and CG : 0.26 [ 0.10 ; 0.42 ] W/kg , with no between-group difference ( primary outcome ) ( P = 0.79 ) .
RESULTS	Maximal walking speed ( P = 0.008 ) and stair climb performance ( P = 0.04 ) improved more in the IG compared to CG , no other between-group differences existed .
CONCLUSIONS	In this trial , supervised PRT twice a week in addition to 5 weekly sessions of unsupervised exercise for 10 weeks was not superior to 7 weekly sessions of unsupervised home-based exercise for 10 weeks in improving the primary outcome , leg-extension power of the operated leg , at the primary endpoint 10 weeks after surgery in THR patients with lower pre-operative function .
BACKGROUND	NCT01214954 .

###24386952
BACKGROUND	Candidate predictive biomarkers for epidermal growth factor receptor inhibitors ( EGFRi ) , skin rash and serum proteomic assays , require further qualification to improve EGFRi therapy in non-small cell lung cancer ( NSCLC ) .
BACKGROUND	In a phase II trial that was closed to accrual because of changes in clinical practice we examined the relationships among candidate biomarkers , quantitative changes in tumor size , progression-free and overall survival .
METHODS	55 patients with progressive NSCLC after platinum therapy were randomized to receive ( Arm A ) cetuximab , followed by pemetrexed at progression , or ( Arm B ) concurrent cetuximab and pemetrexed .
METHODS	All received cetuximab monotherapy for the first 14 days .
METHODS	Pre-treatment serum and weekly rash assessments by standard and EGFRi-induced rash ( EIR ) scales were collected .
RESULTS	43 patients ( 20-Arm A , 23-Arm B ) completed the 14-day run-in .
RESULTS	Median survival was 9.1 months .
RESULTS	Arm B had better median overall ( Arm B = 10.3 [ 95 % CI 7.5 , 16.8 ] ; Arm A = 3.5 [ 2.8 , 11.7 ] months P = 0.046 ) and progression-free survival ( Arm B = 2.3 [ 1.6 , 3.1 ] ; Arm A = 1.6 [ 0.9 , 1.9 ] months P = 0.11 ) .
RESULTS	The EIR scale distributed ratings among 6 rather than 3 categories but ordinal scale rash severity did not predict outcomes .
RESULTS	The serum proteomic classifier and absence of rash after 21 days of cetuximab did .
CONCLUSIONS	Absence of rash after 21 days of cetuximab therapy and the serum proteomic classifier , but not ordinal rash severity , were associated with NSCLC outcomes .
CONCLUSIONS	Although in a small study , these observations were consistent with results from larger retrospective analyses .

###25418987
BACKGROUND	L-Asparaginase is an effective drug in the treatment of childhood acute lymphoblastic leukemia ( ALL ) .
BACKGROUND	The use of L-asparaginase may be limited by serious adverse events of which allergy is the most frequent .
BACKGROUND	The objective of this study was to describe the clinical aspects of PEG-asparaginase allergy in children treated according to the Nordic Society of Paediatric Haematology and Oncology ( NOPHO ) ALL2008 protocol .
METHODS	Children ( 1-17 years ) enrolled in the NOPHO ALL2008 protocol between July 2008 and August 2011 , who developed PEG-asparaginase allergy were identified through the NOPHO ALL2008 toxicity registry .
METHODS	In the NOPHO ALL2008 protocol , patients are randomized to 8 or 15 doses of intramuscular PEG-asparaginase ( Oncaspar ) 1,000 IU/m ( 2 ) / dose administered at 2 or 6 weeks intervals during a total period of 30 weeks .
METHODS	( Clinical trials.gov no : NCT00819351 ) .
RESULTS	Of 615 evaluable patients , 79 patients developed clinical PEG-asparaginase allergy ( cumulative risk ; 13.2 % ) and discontinued PEG-asparaginase therapy for that reason .
RESULTS	PEG-asparaginase allergy occurred after a median of two doses ( 75 % range 2-4 , max 14 ) .
RESULTS	In 58 % of PEG-asparaginase hypersensitive patients , the clinical allergic reactions appeared within 2hr after PEG-asparaginase administration and ranged from mild symptoms to systemic anaphylaxis .
RESULTS	Nine patients experienced an anaphylactic reaction within 1hr and 50min from asparaginase administration ; none were fatal .
RESULTS	Four of 68 patients ( 6 % ) who subsequently received Erwinase therapy also reacted allergic to Erwinase .
CONCLUSIONS	Clinical allergy to PEG-asparaginase occurred early in treatment , was in general moderate in severity , and mostly developed within 2hr after PEG-asparaginase administration .
CONCLUSIONS	The risk of subsequent Erwinase allergic reactions was low .

###25490549
BACKGROUND	Abundant evidence on Xpert MTB/RIF accuracy for diagnosing tuberculosis ( TB ) and rifampicin resistance has been produced , yet there are few data on the population benefit of its programmatic use .
BACKGROUND	We assessed whether the implementation of Xpert MTB/RIF in routine conditions would ( 1 ) increase the notification rate of laboratory-confirmed pulmonary TB to the national notification system and ( 2 ) reduce the time to TB treatment initiation ( primary endpoints ) .
RESULTS	We conducted a stepped-wedge cluster-randomized trial from 4 February to 4 October 2012 in 14 primary care laboratories in two Brazilian cities .
RESULTS	Diagnostic specimens were included for 11,705 baseline ( smear microscopy ) and 12,522 intervention ( Xpert MTB/RIF ) patients presumed to have TB .
RESULTS	Single-sputum-sample Xpert MTB/RIF replaced two-sputum-sample smear microscopy for routine diagnosis of pulmonary TB .
RESULTS	In total , 1,137 ( 9.7 % ) tests in the baseline arm and 1,777 ( 14.2 % ) in the intervention arm were positive ( p < 0.001 ) , resulting in an increased bacteriologically confirmed notification rate of 59 % ( 95 % CI = 31 % , 88 % ) .
RESULTS	However , the overall notification rate did not increase ( 15 % , 95 % CI = -6 % , 37 % ) , and we observed no change in the notification rate for those without a test result ( -3 % , 95 % CI = -37 % , 30 % ) .
RESULTS	Median time to treatment decreased from 11.4 d ( interquartile range [ IQR ] = 8.5-14 .5 ) to 8.1 d ( IQR = 5.4-9 .3 ) ( p = 0.04 ) , although not among confirmed cases ( median 7.5 [ IQR = 4.9-10 .0 ] versus 7.3 [ IQR = 3.4-9 .0 ] , p = 0.51 ) .
RESULTS	Prevalence of rifampicin resistance detected by Xpert was 3.3 % ( 95 % CI = 2.4 % , 4.3 % ) among new patients and 7.4 % ( 95 % CI = 4.3 % , 11.7 % ) among retreatment patients , with a 98 % ( 95 % CI = 87 % , 99 % ) positive predictive value compared to phenotypic drug susceptibility testing .
RESULTS	Missing data in the information systems may have biased our primary endpoints .
RESULTS	However , sensitivity analyses assessing the effects of missing data did not affect our results .
CONCLUSIONS	Replacing smear microscopy with Xpert MTB/RIF in Brazil increased confirmation of pulmonary TB .
CONCLUSIONS	An additional benefit was the accurate detection of rifampicin resistance .
CONCLUSIONS	However , no increase on overall notification rates was observed , possibly because of high rates of empirical TB treatment .
BACKGROUND	ClinicalTrials.gov NCT01363765 .
BACKGROUND	Please see later in the article for the Editors ' Summary .

###25008878
OBJECTIVE	To evaluate the clinical effect of endotracheal lavage with porcine pulmonary surfactant ( PS ) in term neonates with severe meconium aspiration syndrome ( MAS ) .
METHODS	A total of 136 full-term infants with severe MAS who were admitted to the neonatal intensive care unit between January 2010 and June 2013 were randomly and equally divided into PS lavage and PS injection groups .
METHODS	In the PS lavage group , patients were treated with endotracheal lavage using 3-5 mL of diluted PS ( 12 mg/mL ) each time , and the PS injection group was given PS by intratracheal injection at the first dose of 200 mg/kg .
METHODS	Blood gas , oxygenation index ( OI ) , and PaO2/FiO2 ( P/F ) of the two groups were evaluated before and 2 , 12 , 24 , and 48 hours after the treatment , and the duration of mechanical ventilation , complication rate , and cure rate were compared between the two groups .
RESULTS	Compared with the PS injection group , the PS lavage group had significantly higher PaO2 and P/F ration and significantly lower PaCO2 and OI at 12 , 24 , and 48 hours post-treatment ( P < 0.01 ) , a significantly shorter duration of mechanical ventilation ( P < 0.01 ) , a significantly smaller amount of PS ( P < 0.01 ) , a significantly lower complication rate ( P < 0.05 ) , and a significantly higher cure rate ( 97 % vs 88 % ; P < 0.05 ) .
CONCLUSIONS	Compared with the intratracheal injection of PS , endotracheal lavage with diluted PS in term neonates with severe MAS can increase ventilation and oxygenation efficiency , shorten the duration of mechanical ventilation , reduce the complication rate , and increase the cure rate , indicating that this method is a safe and effective therapeutic strategy .

###24261811
OBJECTIVE	To determine whether a combination modified-live bovine respiratory syncytial virus ( BRSV ) vaccine could stimulate protective immunity in young BRSV-seropositive calves following intranasal administration and determine the duration of clinical immunity .
METHODS	Controlled challenge study .
METHODS	Animals-84 dairy calves ( 3 to 11 days old ) .
METHODS	Responses to BRSV challenge of seronegative calves vaccinated under licensing trial conditions were compared with those of seropositive calves 2 times after vaccination .
METHODS	In experiment 1 , young BRSV-seronegative calves were vaccinated intranasally with a minimum immunizing dose of BRSV and challenged with BRSV approximately 7 weeks later .
METHODS	In experiments 2 and 3 , young BRSV-seropositive calves were vaccinated intranasally with a commercially available combination modified-live virus vaccine containing the commercial dose of the BRSV fraction and challenged with BRSV 9 weeks or approximately 14 weeks later , respectively .
RESULTS	In experiments 1 and 2 , BRSV-vaccinated calves had significantly higher Pao2 , significantly fewer lung lesions , and significantly lower mortality rate than did unvaccinated calves subsequent to BRSV challenge .
RESULTS	In contrast , in experiment 3 , there were no differences in Pao2 , lung lesions , or mortality rate between vaccinated and control calves after BRSV challenge approximately 14 weeks after vaccination .
RESULTS	Protected calves in experiment 1 consistently had significant anamnestic mucosal and systemic antibody responses after challenge , whereas in experiments 2 and 3 , antibody responses after challenge were more variable .
CONCLUSIONS	A combination BRSV vaccine administered intranasally to young calves induced protective immunity in the presence of maternal antibodies .
CONCLUSIONS	The duration of immune responses induced by intranasal vaccination was short ( 4 months ) .
CONCLUSIONS	Boosting immunity iatrogenically , or by natural exposure , is probably required to obtain optimal responses to neonatal intranasal vaccination .

###25341806
OBJECTIVE	To describe female lumbar spine motion and posture characteristics during coitus and compare these characteristics across five common coital positions .
OBJECTIVE	Exacerbation of low back pain during coital movements and positions is a prevalent issue reported by female low back pain ( LBP ) patients .
OBJECTIVE	To address this problem , the first study to examine lumbar spine biomechanics during coitus was conducted .
METHODS	Ten healthy males and females performed coitus in the following pre-selected positions and variations : QUADRUPED ( fQUAD1 and fQUAD2 where the female is supporting her upper body with her elbows and hands , respectively ) , MISSIONARY ( fMISS1 and fMISS2 where the female is minimally and more flexed at the hips and knees , respectively ) , and SIDELYING .
METHODS	An electromagnetic motion capture system was used to measure three-dimensional lumbar spine angles that were normalized to maximum active range of motion-a transmitter and receiver were affixed to the skin overlying the lateral aspect of the pelvis and the spinous process of the twelfth thoracic vertebra , respectively .
METHODS	To determine if each coital position had distinct spine kinematic profiles ( i.e. , amplitude probability distribution function and total range of lumbar spine motion ) , separate univariate general linear models followed by Tukey 's honestly significant difference post hoc analysis were used .
METHODS	The presentation of coital positions was randomized .
RESULTS	Female lumbar spine movement varied depending on the coital position ; both variations of QUADRUPED , fQUAD1 and fQUAD2 , were found to use a significantly greater range of spine motion than fMISS2 ( p = 0.017 and p = 0.042 , respectively ) .
RESULTS	With the exception of both variations of MISSIONARY , fMISS1 and fMISS2 , the majority of the range of motion used was in extension .
RESULTS	These findings are most pertinent to patients with LBP that is exacerbated by motions or postures .
RESULTS	Based on the spine kinematic profiles of each position , the least-to-most recommended positions for a female flexion-intolerant patient are : fMISS2 , fMISS1 , fQUAD1 , fSIDE , and fQUAD2 .
RESULTS	These recommendations would be contraindicated for the extension-intolerant patient .
CONCLUSIONS	The findings provided here may guide the clinician 's specific recommendations , including alternative coital positions and/or movement patterns or suggesting a lumbar support , depending on the female LBP patient 's specific motion and posture intolerances .

###25641441
OBJECTIVE	Tremor in Charcot-Marie-Tooth disease ( CMT ) can be disabling .
OBJECTIVE	Cerebellar abnormalities are thought to underpin neuropathic tremor .
OBJECTIVE	Here , we aim to clarify the potential role of the cerebellum in CMT tremor .
METHODS	We assessed prevalence of tremor by questionnaire in 84 patients with CMT .
METHODS	Of those , 23 patients with CMT with and without arm tremor and healthy controls underwent a clinical assessment , classical eyeblink conditioning , electro-oculography , visuomotor adaptation test , tremor recording with surface EMG and accelerometry , and retrospective correlation with nerve conduction studies to investigate the possible mechanisms of tremor generation .
RESULTS	The prevalence study revealed tremor in 21 % of patients and in 42 % of those it caused impairment of function .
RESULTS	Tremor recordings revealed a mild-to-moderate amplitude tremor with a weight load-invariant 7.7 Hz frequency component .
RESULTS	Performance on classical eyeblink conditioning , visuomotor adaptation and electro-oculography were no different between tremulous and non-tremulous patients and healthy controls .
CONCLUSIONS	These results argue against a prominent role for an abnormal cerebellum in tremor generation in the patients studied with CMT .
CONCLUSIONS	Rather , our results suggest an enhancement of the central neurogenic component of physiological tremor as a possible mechanism for tremor in the patients studied .
CONCLUSIONS	This study is the first to propose differing pathogenic mechanisms for subtypes of neuropathic tremor .

###26097987
BACKGROUND	The effect of dexmedetomidine on evoked potentials ( EPs ) has not been elucidated .
BACKGROUND	We aimed to investigate the effect of dexmedetomidine on somatosensory , motor , and visual EPs .
METHODS	After IRB approval , 40 adult patients scheduled for elective spine surgery using total IV anesthesia with propofol and remifentanil were randomly assigned to receive either dexmedetomidine ( n = 20 ) or placebo ( n = 20 ) in a double-blind , placebo-controlled trial .
METHODS	After obtaining informed consent , positioning , and baseline EPs recording , patients were randomly assigned to either IV dexmedetomidine 0.6 g/kg infused over 10 minutes , followed by 0.6 g/kg/h , or a corresponding volume of IV normal saline ( placebo ) .
METHODS	EP measures at 60 30 minutes after initiation of study drug were defined as T1 and at 150 30 minutes were defined as T2 .
METHODS	Changes from baseline to T1 ( primary end point ) and from baseline to T2 ( secondary end point ) in EP latencies ( milliseconds ) and amplitudes ( microvolts ) were compared between groups .
METHODS	Data presented as mean SD ( 95 % confidence interval ) .
RESULTS	Data from 40 patients ( dexmedetomidine : n = 20 ; age , 54 3 years ; 10 males ; placebo : n = 20 ; age , 52 2 years ; 5 males ) were analyzed .
RESULTS	There was no difference between dexmedetomidine versus placebo groups in primary end points : change of somatosensory EPs at T1 , latency : 0.01 1.3 ( -0.64 , 0.65 ) vs 0.01 1.3 ( -0.64 , 0.65 ) , P = 0.43 ( -1.24 , 0.45 ) ; amplitude : 0.03 0.14 ( -0.06 , 0.02 ) vs -0.01 0.13 ( -0.07 , 0.05 ) , P = 0.76 ( -0.074 , 0.1 ) ; motor EPs amplitude at T1 : 65.1 194.8 ( -35 , 165 ; n = 18 ) vs 109.2 241.4 ( -24 , 243 ; n = 16 ) , P = 0.57 ( -113.5 , 241.57 ) ; visual EPs at T1 ( right eye ) , amplitude : 2.3 3.6 ( -0.4 , 5.1 ; n = 11 ) vs 0.3 6.0 ( -3.3 , 3.9 ; n = 16 ) , P = 0.38 ( -6.7 , 2.6 ) ; latency N1 : 2.3 3.6 ( -0.4 , 5.1 ) vs 0.3 6.0 ( -3.3 , 3.9 ) , P = 0.38 ( -6.7 , 2.6 ) ; latency P1 : -1.6 13.4 ( -11.9 , 8.7 ) vs -1.4 8.1 ( -6.3 , 3.5 ) , P = 0.97 ( -9.3 , 9.7 ) or secondary end points .
RESULTS	There were no differences between right and left visual EPs either at T1 or at T2 .
CONCLUSIONS	In clinically relevant doses , dexmedetomidine as an adjunct to total IV anesthesia does not seem to alter EPs and therefore can be safely used during surgeries requiring monitoring of EPs .

###24405345
BACKGROUND	Teaching in the presence of the patient is an acceptable model in medical settings .
BACKGROUND	Questions have been raised about the appropriateness of this type of teaching ( exam room teaching ) with patients with mental health issues .
OBJECTIVE	This prospective randomized controlled study examined outpatient exam room teaching in a psychiatric setting .
METHODS	In 2011-2012 , patients in the adult outpatient psychiatry clinic at the University of Iowa were randomized to have faculty-learner presentations either in the presence of the patient or in the conference room .
METHODS	Teaching encounters were timed and faculty , learners , and patients completed post encounter surveys .
RESULTS	Participation included 126 patients , nine faculty , and 16 residents .
RESULTS	Comparison of patient encounters randomized to exam room ( n = 58 ) or conference room ( n = 64 ) demonstrated that exam room teaching was roughly twice as time efficient as conference room teaching ( p .0001 ) .
RESULTS	Patients expressed a preference for exam room teaching during future visits ( p .003 ) for those patients who experienced exam room teaching during the study .
RESULTS	Faculty were generally comfortable with exam room teaching and felt it had some advantages for patient decision making .
RESULTS	Learners felt they had to choose their words more carefully in exam room teaching and expressed some concerns about depth of teaching .
CONCLUSIONS	Once exposed to exam room teaching , this model is acceptable and feasible to faculty , learners , and patients in a psychiatry clinic setting .

###25432788
BACKGROUND	Over 50 % of patients with head and neck squamous cell carcinoma ( HNSCC ) present with locoregionally advanced disease .
BACKGROUND	Those at intermediate-to-high risk of recurrence after definitive therapy exhibit advanced disease based on tumour size or lymph node involvement , non-oropharynx primary sites , human papillomavirus ( HPV ) - negative oropharyngeal cancer , or HPV-positive oropharynx cancer with smoking history ( > 10-pack-years ) .
BACKGROUND	Non-surgical approaches include concurrent chemoradiotherapy , induction chemotherapy followed by definitive radiotherapy or chemoradiotherapy , or radiotherapy alone .
BACKGROUND	Following locoregional therapies ( including surgical salvage of residual cervical nodes ) , no standard intervention exists .
BACKGROUND	Overexpression of epidermal growth factor receptor ( EGFR ) , an ErbB family member , is associated with poor prognosis in HNSCC .
BACKGROUND	EGFR-targeted cetuximab is the only targeted therapy that impacts overall survival and is approved for HNSCC in the USA or Europe .
BACKGROUND	However , resistance often occurs , and new approaches , such as targeting multiple ErbB family members , may be required .
BACKGROUND	Afatinib , an irreversible ErbB family blocker , demonstrated antiproliferative activity in preclinical models and comparable clinical efficacy with cetuximab in a randomized phase II trial in recurrent or metastatic HNSCC .
BACKGROUND	LUX-Head & Neck 2 , a phase III study , will assess adjuvant afatinib versus placebo following chemoradiotherapy in primary unresected locoregionally advanced intermediate-to-high-risk HNSCC .
METHODS	Patients with primary unresected locoregionally advanced HNSCC , in good clinical condition with unfavourable risk of recurrence , and no evidence of disease after chemoradiotherapy will be randomized 2:1 to oral once-daily afatinib ( 40 mg starting dose ) or placebo .
METHODS	As HPV status will not be determined for eligibility , unfavourable risk is defined as non-oropharynx primary site or oropharynx cancer in patients with a smoking history ( > 10 pack-years ) .
METHODS	Treatment will continue for 18 months or until recurrence or unacceptable adverse events occur .
METHODS	The primary endpoint measure is duration of disease-free survival ; secondary endpoint measures are disease-free survival rate at 2 years , overall survival , health-related quality of life and safety .
CONCLUSIONS	Given the unmet need in the adjuvant treatment of intermediate-to-high-risk HNSCC patients , it is expected that LUX-Head & Neck 2 will provide new insights into treatment in this setting and might demonstrate the ability of afatinib to significantly improve disease-free survival , compared with placebo .
BACKGROUND	ClinicalTrials.gov NCT01345669 .

###25603890
BACKGROUND	Topical tretinoin is considered the gold standard to treat photoaged skin , but it is associated with side effects and only available upon prescription .
OBJECTIVE	To compare the efficacy , tolerance , and perception of a fixed proprietary combination ( Retinol 0.2 % / LR2412 2 % ) vs. tretinoin 0.025 % cream in women with photoaged skin .
METHODS	In this randomized , parallel , double-blind , controlled clinical study , women applied to the entire face for 3months in the morning a SPF 50 sunscreen and in the evening either the association of Retinol 0.2 % / LR2412 2 % or tretinoin 0.025 % .
METHODS	Clinical and instrumental parameters were assessed at days 0 , 28 , 56 , and 84 .
METHODS	Subject perception of the efficacy , tolerance and cosmeticity of the tested products were assessed at days 28 , 56 , and 84 .
RESULTS	A total of 120 women ( 60 to Retinol 0.2 % / LR2412 2 % cream and 60 to tretinoin 0.025 % cream ) were included in the study .
RESULTS	Both products improved considerably wrinkles , mottled pigmentation , pores , and global photodamage .
RESULTS	No statistically significant differences were noted between Retinol 0.2 % / LR2412 2 % cream and tretinoin 0.025 % cream .
RESULTS	Adverse effects were mostly graded mild .
RESULTS	Overall , Retinol 0.2 % / LR2412 2 % cream was better tolerated than tretinoin 0.025 % cream .
RESULTS	At all visits , subject perception of the association of Retinol 0.2 % / LR2412 2 % was either comparable to or better than tretinoin 0.025 % cream .
CONCLUSIONS	The treatment outcome of Retinol 0.2 % / LR2412 2 % cream does not differ from the one of tretinoin 0.025 % cream .
CONCLUSIONS	Clinical results were not statistically different .
CONCLUSIONS	Furthermore , Retinol 0.2 % / LR2412 2 % cream is better tolerated and better perceived by women used to rejuvenation procedures .

###24293132
BACKGROUND	Central blood pressure ( BP ) , an important measure of cardiovascular risk , has been shown to be effectively reduced by calcium channel blockade with amlodipine ( AML ) plus renin-angiotensin system blockade by the angiotensin-converting enzyme inhibitor , perindopril ( PER ) .
BACKGROUND	The aim of the SEVITENSION study was to compare the central effects of PER/AML against renin-angiotensin system blockade with the angiotensin II receptor blocker olmesartan ( OLM ) plus AML .
METHODS	In this multicenter , parallel group , non-inferiority study , patients received AML 10 mg during a 2 - to 4-week run-in before randomization to 24 weeks of double-blind treatment with the fixed-dose combination of OLM/AML 40/10 mg or PER/AML 8/10 mg .
METHODS	Hydrochlorothiazide was added at Weeks 4 , 8 , or 12 in patients with inadequate BP control .
METHODS	The primary efficacy variable was the absolute change in central systolic BP ( CSBP ) from baseline to the final examination , measured by radial artery applanation tonometry and analyzed by parametric analysis of covariance .
METHODS	Secondary variables included 24-h ambulatory and seated BP measurements as well as BP normalization .
RESULTS	Of 600 patients enrolled , 486 were randomized ( 244 to OLM/AML 40/10 mg , 242 to PER/AML 8/10 mg ) .
RESULTS	The reduction in CSBP was larger with OLM/AML ( 14.5 0.83 mmHg ) than with PER/AML ( 10.4 0.84 mmHg ) .
RESULTS	The between-group difference was -4.2 1.18 mmHg with 95 % confidence intervals ( -6.48 to -1.83 mmHg ) within the predefined non-inferiority margin ( 2 mmHg ) .
RESULTS	An integrated superiority test confirmed that OLM/AML was superior to PER/AML ( p < 0.0001 ) in reducing CSBP .
RESULTS	The superiority of OLM/AML over PER/AML was also established for the majority of secondary efficacy variables ; at the final examination , 75.6 % of OLM/AML recipients achieved BP normalization ( mean seated systolic BP/diastolic BP < 140/90 mmHg ) compared with 57.5 % of PER/AML recipients ( p < 0.0001 ) .
CONCLUSIONS	The combination of OLM/AML was superior to PER/AML in reducing CSBP and other efficacy measures , including a significantly higher rate of BP normalization .

###25280076
OBJECTIVE	The objective of this study was to compare the effectiveness of using a virtual environment ( VE ) versus traditional paper floor plans ( FPs ) to prepare nurses for wayfinding in a new hospital building .
BACKGROUND	This study was designed to control for variables such as task complexity and individual ability that have been missed in other media comparison studies .
METHODS	Thirty nurses were assigned to the VE or FP condition using a randomized block experimental design .
METHODS	Subjects were blocked by alternate ranks on spatial/navigational ability and computer attitude/experience and randomly assigned to conditions .
METHODS	Nurses received instruction with either a VE or FP condition .
METHODS	Wayfinding tasks were then completed with trained observers at the new hospital under construction .
RESULTS	The investigators found no significant differences between the wayfinding performance or postintervention confidence levels of subjects .
RESULTS	Instruction using both media improved wayfinding and navigation skills .
RESULTS	Qualitative findings suggest that interactions of the instructional style , media , and learner influence information retention and transfer .
CONCLUSIONS	Although the virtual media did not prove to be more effective than FPs , it was equally effective for learning wayfinding and navigation skills in a new hospital .
CONCLUSIONS	Nursing leaders may want to consider use of 3-dimensional VEs as an early method to provide repetitive practice for learning how to navigate a new large-scale space .

###25060669
BACKGROUND	PSA and PSA velocity ( PSAV , rate of PSA change over time ) are biomarkers for diagnosis and prognosis of prostate cancer .
BACKGROUND	Men who are at high risk for prostate cancer also have associated comorbidities for which they are taking NSAIDs and statins for long periods ; therefore , it is important to understand the effect of these medications on markers used to assess prostate cancer risk .
METHODS	Using a population of 699 men , multiple linear regressions were used to investigate the associations between PSA and concomitant medications , and mixed-effects models were used to investigate these associations with PSAV .
RESULTS	After adjusting for selenium use , age , race , body mass index , and pack-years of smoking , aspirin , other NSAIDs , or statins did not demonstrate statistically significant associations with PSA ( P = 0.79 , 0.68 , and 0.79 , respectively ) or PSAV ( P = 0.23 , 0.43 , and 0.84 , respectively ) .
RESULTS	Results were not altered upon stratifying the sample between men who developed prostate cancer during the course of the study and those who did not .
CONCLUSIONS	Results from this study indicate that chronic use of aspirin , other NSAIDs , or statins did not affect PSA levels or PSAV in men at high risk for prostate cancer .
CONCLUSIONS	Larger prospective studies designed to investigate these relationships are needed to confirm this result .
CONCLUSIONS	Long-term use of NSAIDs or statins in men at high risk for prostate cancer may not interfere with the diagnosis or prognosis of this disease , and supports appropriate use of these medications with regard to prostate cancer risk .

###24598243
OBJECTIVE	Exogenous GLP-1 slows gastric emptying in health and diabetes leading to diminished glycemic excursions .
OBJECTIVE	Gastric emptying is markedly accelerated by hypoglycemia .
OBJECTIVE	The primary objective was to determine whether GLP-1 attenuates the acceleration of gastric emptying induced by hypoglycemia .
METHODS	Ten healthy volunteers were studied on four separate days in a randomized double-blind fashion .
METHODS	Blood glucose was stabilized using a glucose/insulin clamp at hypoglycemia ( 2.6 mmol/L on two occasions [ hypo ] ) or euglycemia ( 6.0 mmol/L on two occasions [ eu ] ) between T = -15 and 45 min before clamping at 6.0 mmol/L until 180 min .
METHODS	During hypoglycemia and euglycemia , subjects received intravenous GLP-1 ( 1.2 pmol/kg/min ) or placebo .
METHODS	At T = 0 min , subjects ingested 100 g beef mince labeled with 20 MBq ( 99m ) Tc-sulfur-colloid and 3 g of 3-O-methyl-glucose ( 3-OMG ) , a marker of glucose absorption .
METHODS	Gastric emptying was measured scintigraphically from T = 0 to 180 min and serum 3-OMG taken at 15-min intervals .
METHODS	The areas under the curve for gastric emptying and 3-OMG concentration were analyzed using one-way repeated-measures ANOVA with Bonferroni-Holm adjusted post hoc tests .
RESULTS	Gastric emptying was accelerated during hypoglycemia ( hypo/placebo vs. eu/placebo ; P < 0.001 ) , as was glucose absorption ( P < 0.03 ) .
RESULTS	GLP-1 slowed emptying during euglycemia ( eu/placebo vs. eu/GLP -1 ; P < 0.001 ) .
RESULTS	However , hypoglycemia-induced acceleration of gastric emptying on placebo was markedly diminished by GLP-1 ( hypo/placebo vs. hypo/GLP -1 ; P < 0.008 ) , as was glucose absorption ( P < 0.01 ) .
CONCLUSIONS	Acute administration of exogenous GLP-1 attenuates , but does not abolish , the acceleration of gastric emptying by insulin-induced hypoglycemia in healthy subjects .

###24886037
BACKGROUND	For future etiologic cohort studies in runners it is important to identify whether ( hyper ) pronation of the foot , decreased ankle joint dorsiflexion ( AJD ) and the degree of the extension of the first Metatarsophalangeal joint ( MTP1 ) are risk factors for running injuries and to determine possible sex differences.These parameters are frequently determined with the navicular drop test ( NDT ) Stance and Single Limb-Stance , the Ankle Joint Dorsiflexion-test , and the extension MTP1-test in a healthy population .
BACKGROUND	The aim of this clinimetric study was to determine the reproducibility of these three orthopaedic tests in runners , using minimal equipment in order to make them applicable in large cohort studies .
BACKGROUND	Furthermore , we aimed to determine possible sex differences of these tests .
METHODS	The three orthopaedic tests were administered by two sports physiotherapists in a group of 42 ( 22 male and 20 female ) recreational runners .
METHODS	The intra-class correlation ( ICC ) for interrater and intrarater reliability and the standard error of measurement ( SEM ) were calculated .
METHODS	Bland and Altman plots were used to determine the 95 % limits of agreements ( LOAs ) .
METHODS	Furthermore , the difference between female and male runners was determined .
RESULTS	The ICC 's of the NDT were in the range of 0.37 to 0.45 , with a SEM in the range of 2.5 to 5 mm .
RESULTS	The AJD-test had an ICC of 0.88 and 0.86 ( SEM 2.4 and 8.7 ) , with a 95 % LOA of -6.0 to 6.3 and -5.3 to 7.9 , and the MTP1-test had an ICC of 0.42 and 0.62 ( SEM 34.4 and 9.9 ) , with a 95 % LOA of -30.9 to 20.7 and -20 to 17.8 for the interrater and intrarater reproducibility , respectively.Females had a significantly ( p < 0.05 ) lower navicular drop score and higher range of motion in extension of the MTP1 , but no sex differences were found for ankle dorsiflexion ( p 0.05 ) .
CONCLUSIONS	The reproducibility for the AJD test in runners is good , whereas that of the NDT and extension MTP1 was moderate or low .
CONCLUSIONS	We found a difference in NDT and MTP1 mobility between female and male runners , however this needs to be established in a larger study with more reliable test procedures .

###25817374
BACKGROUND	There is little evidence to guide the management of women with hypertensive disorders in late preterm pregnancy .
BACKGROUND	We investigated the effect of immediate delivery versus expectant monitoring on maternal and neonatal outcomes in such women .
METHODS	We did an open-label , randomised controlled trial , in seven academic hospitals and 44 non-academic hospitals in the Netherlands .
METHODS	Women with non-severe hypertensive disorders of pregnancy between 34 and 37 weeks of gestation were randomly allocated to either induction of labour or caesarean section within 24 h ( immediate delivery ) or a strategy aimed at prolonging pregnancy until 37 weeks of gestation ( expectant monitoring ) .
METHODS	The primary outcomes were a composite of adverse maternal outcomes ( thromboembolic disease , pulmonary oedema , eclampsia , HELLP syndrome , placental abruption , or maternal death ) , and neonatal respiratory distress syndrome , both analysed by intention-to-treat .
METHODS	This study is registered with the Netherlands Trial Register ( NTR1792 ) .
RESULTS	Between March 1 , 2009 , and Feb 21 , 2013 , 897 women were invited to participate , of whom 703 were enrolled and randomly assigned to immediate delivery ( n = 352 ) or expectant monitoring ( n = 351 ) .
RESULTS	The composite adverse maternal outcome occurred in four ( 11 % ) of 352 women allocated to immediate delivery versus 11 ( 31 % ) of 351 women allocated to expectant monitoring ( relative risk [ RR ] 036 , 95 % CI 012-111 ; p = 0069 ) .
RESULTS	Respiratory distress syndrome was diagnosed in 20 ( 57 % ) of 352 neonates in the immediate delivery group versus six ( 17 % ) of 351 neonates in the expectant monitoring group ( RR 33 , 95 % CI 14-82 ; p = 0005 ) .
RESULTS	No maternal or perinatal deaths occurred .
CONCLUSIONS	For women with non-severe hypertensive disorders at 34-37 weeks of gestation , immediate delivery might reduce the already small risk of adverse maternal outcomes .
CONCLUSIONS	However , it significantly increases the risk of neonatal respiratory distress syndrome , therefore , routine immediate delivery does not seem justified and a strategy of expectant monitoring until the clinical situation deteriorates can be considered .
BACKGROUND	ZonMw .

###25878177
OBJECTIVE	Evaluate the impact of concomitant enzyme ( CYP3A4 ) - inducer antiepileptic drugs ( EIAEDs ) on the efficacy and safety of perampanel in patients from the 3 phase-III clinical trials .
METHODS	Patients with pharmacoresistant partial-onset seizures in the 3 phase-III clinical studies were aged 12 years and older and receiving 1 to 3 concomitant antiepileptic drugs .
METHODS	Following 6-week baseline , patients were randomized to once-daily , double-blind treatment with placebo or perampanel 8 or 12 mg ( studies 304 and 305 ) or placebo or perampanel 2 , 4 , or 8 mg ( study 306 ) .
RESULTS	Treatment response assessed by median percent reduction in seizure frequency and responder rates improved with perampanel compared with placebo .
RESULTS	However , at 8 and 12 mg , the treatment response was significantly greater in patients receiving non-EIAEDs .
RESULTS	The treatment effect ( perampanel-placebo ) also demonstrated a dose-dependent increase in all patients .
RESULTS	The overall incidence of treatment-emergent adverse events was similar regardless of the presence of EIAEDs .
RESULTS	Occurrence of some adverse events , such as fatigue , somnolence , dizziness , irritability , was greater in patients receiving non-EIAEDs , as was discontinuation because of adverse events .
CONCLUSIONS	Perampanel shows efficacy and safety in the presence and absence of EIAEDs .
CONCLUSIONS	As systemic exposure to perampanel increases , so does efficacy .
CONCLUSIONS	Given the extensive metabolism of perampanel , systemic exposure is clearly reduced with concomitant administration of CYP3A4 inducers .
CONCLUSIONS	This supports the strategy of dosing perampanel to clinical effect .
CONCLUSIONS	Recognition of these pharmacokinetic interactions will be important in the optimization of this novel medication .
METHODS	This study provides Class II evidence that 2 to 12 mg/d doses of perampanel reduced seizure frequency and improved responder rate in the presence and absence of EIAEDs .

###25037988
BACKGROUND	Optimum duration of dual antiplatelet treatment ( DAPT ) after coronary stenting remains uncertain , with an unknown efficacy to safety ratio of extended treatment leading to discrepancies between international guidelines and clinical practice .
BACKGROUND	We assessed whether DAPT continuation beyond 1 year after coronary stenting is beneficial .
METHODS	This analysis was a planned extension of the previously published ARCTIC-Monitoring trial , in which we randomly allocated 2440 patients to a strategy of platelet function testing with antiplatelet treatment adjustment or a conventional strategy after coronary stenting with drug-eluting stent ( DES ) .
METHODS	We recruited patients ( aged 18 years or older ) scheduled for planned DES implantation at 38 centres in France .
METHODS	After 1 year of follow-up , patients without contraindication to interruption of DAPT were eligible for a second randomisation to this second phase of the study ( ARCTIC-Interruption ) .
METHODS	Using a computer-generated randomisation sequence ( 1:1 ; stratified by centre ) , we allocated patients to a strategy of interruption of DAPT where the thienopyridine was interrupted and single aspirin antiplatelet treatment was maintained ( interruption group ) or a strategy of DAPT continuation for 6-18 months ( continuation group ) .
METHODS	The primary endpoint was the composite of death , myocardial infarction , stent thrombosis , stroke , or urgent revascularisation , analysed by intention to treat .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00827411 .
RESULTS	Between Jan 4 , 2011 , and March 3 , 2012 , 1259 eligible patients were randomly allocated to treatment in ARCTIC-Interruption : 624 to the interruption group and 635 to the continuation group .
RESULTS	After a median follow-up of 17 months ( IQR 15-18 ) , the primary endpoint occurred in 27 ( 4 % ) patients in the interruption group and 24 ( 4 % ) patients in the continuation group ( hazard ratio [ HR ] 117 [ 95 % CI 068-203 ] ; p = 058 ) .
RESULTS	STEEPLE major bleeding events occurred more often in the continuation group ( seven [ 1 % ] patients ) compared with the interruption group ( one [ < 05 % ] patient ; HR 015 [ 002-120 ] ; p = 0073 ) .
RESULTS	Major or minor bleedings were also more common in the continuation group compared with the interruption group ( 12 [ 2 % ] patients vs three [ 1 % ] patients ; HR 026 [ 007-091 ] ; p = 004 ) .
CONCLUSIONS	Our finding suggests no apparent benefit but instead harm with extension of DAPT beyond 1 year after stenting with DES when no event has occurred within the first year after stenting .
CONCLUSIONS	No conclusion can be drawn for high-risk patients who could not be randomised .
CONCLUSIONS	The consistency between findings from all trials of such interruption suggests the need for a reappraisal of guidelines for DAPT after coronary stenting towards shorter duration of treatment .
BACKGROUND	Allies in Cardiovascular Trials Initiatives and Organized Networks ( ACTION Study Group ) , Fondation de France , Sanofi-Aventis , Cordis , Medtronic , Boston Scientific , Fondation SGAM .

###24731062
OBJECTIVE	To evaluate the effect of different bracket types on the levels of Streptococcus mutans ( SM ) and Lactobacillus ( LB ) in saliva , in plaque , and on the periodontal condition .
METHODS	Forty patients aged 14 to 16 years , who had Angle Class I malocclusion with minimal crowding , were nonsmokers , were without systematic disease , and did not use antibiotics or oral mouth rinses during the 3-month period before the study were randomly selected .
METHODS	The patients were subdivided into two groups with random allocation of bracket type : conventional brackets ( CB ; Avex Mx , OPAL orth . )
METHODS	with steel wire ligature or self-ligating brackets ( SLB ; F1000 , Leone S.p.A. ) .
METHODS	Microbial and periodontal records were obtained before bonding ( T1 ) and 1 month after bonding ( T2 ) .
METHODS	Microbial samples were collected from the stimulated saliva and the plaque from the labial surfaces of the upper and lower lateral incisors .
METHODS	To estimate the number of colony-forming units of SM and LB , Dentocult SM and LB kits were used .
METHODS	The plaque index ( PI ) , gingival index ( GI ) , and pocket depth ( PD ) values were recorded to evaluate the periodontal condition .
METHODS	Paired t-test and Mann-Whitney U-test were used to compare the groups statistically .
RESULTS	No significant differences occurred in SM or LB colonization between the groups .
RESULTS	In the SLB group , PI , GI , and PD values increased significantly ( P < .05 ) .
RESULTS	A greater increase was found in PD value in the SLB group ( 0.98 mm ) compared with the CB group ( 0.04 mm ; P < .05 ) .
CONCLUSIONS	The F1000 SLB do not have an advantage over Avex Mx CB with respect to periodontal status and colonization of SM and LB .

###24349516
BACKGROUND	Autophagy has been reported to be essential for pre-implantation development and embryo survival .
BACKGROUND	However , its role in placental development and regulation of autophagy during pregnancy remain unclear .
BACKGROUND	The aims of this study were to ( 1 ) study autophagy by characterizing changes in levels of beclin-1 , DRAM , and LC3B in human placenta throughout gestation ; ( 2 ) determine whether autophagy is involved in regulation of trophoblast invasion in JEG-3 cells ( a choriocarcinoma cell line ) ; ( 3 ) examine the effects of reduced oxygen and glucose on the autophagic changes ; and ( 4 ) investigate the effect of reoxygenation and supplementation of glucose after oxygen-glucose deprivation ( OGD ) on the autophagic changes in primary cytotrophoblasts obtained from normal term pregnancy .
RESULTS	An analysis of 40 placental samples representing different gestational stages showed ( 1 ) no significant differences in beclin-1 , DRAM , and LC3B-II levels in placentas between early and mid-gestation , and late gestation with vaginal delivery ; ( 2 ) placentas from late gestation with cesarean section had lower levels of LC3B-II compared to early and mid-gestation , and late gestation with vaginal delivery ; levels of DRAM were also lower compared to placentas from early and mid-gestation ; and ( 3 ) using explant cultures , villous tissues from early and late gestation had similar rates of autophagic flux under physiological oxygen concentrations .
RESULTS	Knockdown of BECN1 , DRAM , and LC3B had no effects on viability and invasion activity of JEG-3 cells .
RESULTS	On the other hand , OGD caused a significant increase in the levels of LC3B-II in primary cytotrophoblasts , while re-supplementation of oxygen and glucose reduced these changes .
RESULTS	Furthermore , there were differential changes in levels of beclin-1 , DRAM , and LC3B-II in response to changes in oxygen and glucose levels .
CONCLUSIONS	Our results indicate that autophagy is involved in development of the human placenta and that changes in oxygen and glucose levels participate in regulation of autophagic changes in cytotrophoblast cells .

###25787997
BACKGROUND	It is known that increased potassium and reduced sodium intakes can improve postprandial endothelial function .
BACKGROUND	However , the effect of increasing potassium in the presence of high sodium in the postprandial state is not known .
OBJECTIVE	We aimed to determine the effect of high potassium and high sodium on postprandial endothelial function as assessed by using flow-mediated dilatation ( FMD ) and arterial compliance as assessed by using pulse wave velocity ( PWV ) and central augmentation index ( AIx ) .
METHODS	Thirty-nine healthy , normotensive volunteers [ 21 women and 18 men ; mean SD age : 37 15 y ; BMI ( in kg/m ( 2 ) ) : 23.0 2.8 ] received a meal with 3 mmol K and 65 mmol Na ( low-potassium , high-sodium meal ( LKHN ) ] , a meal with 38 mmol K and 65 mmol Na [ high-potassium , high-sodium meal ( HKHN ) ] , and a control meal with 3 mmol K and 6 mmol Na ( low-potassium , low-sodium meal ) on 3 separate occasions in a randomized crossover trial .
METHODS	Brachial artery FMD , carotid-femoral PWV , central AIx , and blood pressure ( BP ) were measured while participants were fasting and at 30 , 60 , 90 , and 120 min after meals .
RESULTS	Compared with the LKHN , the addition of potassium ( HKHN ) significantly attenuated the postmeal decrease in FMD ( P-meal by time interaction < 0.05 ) .
RESULTS	FMD was significantly lower after the LKHN than after the HKHN at 30 min ( P < 0.01 ) .
RESULTS	AIx decreased after all meals ( P < 0.05 ) .
RESULTS	There were no significant differences in AIx , PWV , or BP between treatments over time .
CONCLUSIONS	The addition of potassium to a high-sodium meal attenuates the sodium-induced postmeal reduction in endothelial function as assessed by FMD .
CONCLUSIONS	This trial was registered at http://www.anzctr.org.au/ as ACTRN12613000772741 .

###25520426
BACKGROUND	Antiretroviral preexposure prophylaxis ( PrEP ) , using daily oral combination tenofovir disoproxil fumarate plus emtricitabine , is an effective human immunodeficiency virus ( HIV ) prevention strategy for populations at high risk of HIV acquisition .
BACKGROUND	Although the primary mode of action for the protective effect of PrEP is probably direct antiviral activity , nonhuman primate studies suggest that PrEP may also allow for development of HIV-specific immune responses , hypothesized to result from aborted HIV infections providing a source of immunologic priming .
BACKGROUND	We sought to evaluate whether PrEP affects the development of HIV-specific immune response in humans .
RESULTS	Within a PrEP clinical trial among high-risk heterosexual African men and women , we detected HIV-specific CD4 ( + ) and CD8 ( + ) peripheral blood T-cell responses in 10 % -20 % of 247 subjects evaluated .
RESULTS	The response rate and magnitude of T-cell responses did not vary significantly between those assigned PrEP versus placebo , and no significant difference between those assigned PrEP and placebo was observed in measures of innate immune function .
CONCLUSIONS	We found no evidence to support the hypothesis that PrEP alters either the frequency or magnitude of HIV-specific immune responses in HIV-1-exposed seronegative individuals .
CONCLUSIONS	These results suggest that PrEP is unlikely to serve as an immunologic prime to aid protection by a putative HIV vaccine .

###24271159
BACKGROUND	The extralevator abdominoperineal excision ( ELAPE ) has been proposed as oncologically superior to standard abdominoperineal excision ( SAPE ) .
BACKGROUND	However , little is known regarding comparative margins achieved in ELAPE and SAPE .
BACKGROUND	The purpose of this study was to compare patterns of tissue removal between these two groups that can aid patient selection .
METHODS	Twenty APE specimens , comprising 10 SAPEs and 10 ELAPEs , were selected randomly from a single UK centre .
METHODS	Transverse slices of pathological specimens were matched to corresponding axial MRI images obtained from conventional pelvic MRI imaging .
METHODS	Measurements from the muscularis propria to the resection margin [ muscularis to margin ( MTM ) distance ] were recorded by height ( from anal verge ) and quadrant for each surgical group .
METHODS	MTM distances achieved on histopathological assessment were also compared to MRI assessed distances necessary to achieve a clear CRM .
RESULTS	ELAPE specimens had a greater mean MTM distance than for SAPE ( 7.75 vs. 5.61 mm , p = 0.02 ) .
RESULTS	ELAPE had significantly greater MTM distances in lateral and posterior quadrants ( p < 0.05 ) than SAPE at 30-49 mm .
RESULTS	There was no significant difference in mean anterior distances ( 1.57 vs. 1.16 mm , p = 0.507 ) with the smallest difference at a height of 60-69 mm .
RESULTS	Two ( 2 % ) of pathological MTM distances within ELAPE group failed to achieve the minimum MRI assessed distance compared with 30 ( 23 % ) in the SAPE group , which had higher CRM positivity .
CONCLUSIONS	ELAPE appears to confer oncological benefit over SAPE but with notable exceptions , including tumours located above and below the puborectalis sling and anteriorly at the level of prostate where exenteration may be more appropriate .

###24902655
BACKGROUND	In bariatric surgery , non - or mini-invasive modalities for cardiovascular monitoring are addressed to meet individual variability in hydration needs .
BACKGROUND	The aim of the study was to compare conventional monitoring to an individualized goal-directed therapy ( IGDT ) regarding the need of perioperative fluids and cardiovascular stability .
METHODS	Fifty morbidly obese patients were consecutively scheduled for laparoscopic bariatric surgery ( ClinicalTrials.gov Identifier : NCT01873183 ) .
METHODS	The intervention group ( IG , n = 30 ) was investigated preoperatively with transthoracic echocardiography ( TTE ) and rehydrated with colloid fluids if a low level of venous return was detected .
METHODS	During surgery , IGDT was continued with a pulse-contour device ( FloTrac ) .
METHODS	In the control group ( CG , n = 20 ) , conventional monitoring was conducted .
METHODS	The type and amount of perioperative fluids infused , vasoactive/inotropic drugs administered , and blood pressure levels were registered .
RESULTS	In the IG , 213 204 mL colloid fluids were administered as preoperative rehydration vs. no preoperative fluids in the CG ( p < 0.001 ) .
RESULTS	During surgery , there was no difference in the fluids administered between the groups .
RESULTS	Mean arterial blood pressures were higher in the IG vs. the CG both after induction of anesthesia and during surgery ( p = 0.001 and p = 0.001 ) .
CONCLUSIONS	In morbidly obese patients suspected of being hypovolemic , increased cardiovascular stability may be reached by preoperative rehydration .
CONCLUSIONS	The management of rehydration should be individualized .
CONCLUSIONS	Additional invasive monitoring does not appear to have any effect on outcomes in obesity surgery .

###25217858
OBJECTIVE	To explore the effect of body position ( sitting vs supine ) on intraocular pressure ( IOP ) in children , as assessed by the Icare PRO and the Tono-Pen .
METHODS	Prospective clinical study .
METHODS	Children with known or suspected glaucoma and those without glaucoma were recruited from the Duke Eye Center pediatric clinic .
METHODS	Subjects underwent tonometry in both eyes while upright ( sitting ) , after instillation of topical anesthetic , with either the Icare PRO or the Tono-Pen first , and then the second instrument ( order randomized ) .
METHODS	Goldmann applanation tonometry ( GAT ) was then performed by a clinician masked to the previous measurements .
METHODS	The subjects were then placed in the supine position for 5 minutes , and tonometry using the Icare PRO and the Tono-Pen was obtained , in the same order used when they were the sitting position .
RESULTS	Enrolled were 47 children ( 94 eyes ) .
RESULTS	Mean seated IOP for GAT , Icare PRO and Tono-Pen were 16.4 4.2 , 17.5 3.5 , and 18.0 3.9 mm Hg , respectively .
RESULTS	The mean supine IOP for the Icare PRO and Tono-Pen were 18.4 4.5 and 18.8 4.2 mm Hg , respectively .
RESULTS	This rise was +0.9 2.3 mm Hg for Icare PRO ( P = 0.01 ) and +0.7 1.8 mm Hg for Tono-Pen ( P = 0.009 ) , respectively .
CONCLUSIONS	In children , Icare PRO tonometry correlates well with GAT in the sitting position , and with the Tono-Pen in both the sitting and supine positions .
CONCLUSIONS	IOP rises when a child changes position from sitting to supine when measured by the Icare PRO or the Tono-Pen .
CONCLUSIONS	However , the increase , which is less than 1 mm Hg , seems clinically insignificant and is unlikely to alter glaucoma management in children .

###24400639
BACKGROUND	To investigate the influence of the overall intraocular lens ( IOL ) diameter on posterior capsule opacification ( PCO ) formation .
METHODS	In this prospective randomized clinical trial , 124 eyes of 62 patients with bilateral age-related cataract were included .
METHODS	Each patient received a Corneal A501D IOL in one eye and a Corneal J501D IOL in the fellow eye .
METHODS	Best corrected visual acuity ( BCVA ) and digital slitlamp photographs were taken a 1h , 1 week , 1 , 3 , 6 and 12 months postoperatively .
METHODS	The amount of PCO was assessed subjectively at the slitlamp and objectively using automated image-analysis software .
RESULTS	We found a mean BCVA of 0.810.2 for the Corneal A501D group and 0.790.21 for the Corneal J501D group .
RESULTS	There was no significant difference 12 months after surgery between the two IOLs ( p > 0.05 ) .
RESULTS	Objective PCO assessment resulted in a mean PCO score ( scale 0-10 ) of 1.651.71 was found for the Corneal J501D group and a score of 1.541.64 was found for the Corneal A501D group ( p > 0.05 ) .
RESULTS	The subjective PCO assessment at 1 year resulted in a mean PCO score of 2.01.74 in the Corneal J501D group and 2.131.64 in the Corneal A501D group ( p > 0.05 ) .
CONCLUSIONS	Both investigated IOLs showed good clinical performance regarding PCO and BCVA .
CONCLUSIONS	Our study suggests that the use of an IOL with variable total diameter seems not to influence the rate of PCO formation .

###24712204
OBJECTIVE	To assess the efficacy of two antimicrobial prophylaxis regimens , a short cycle and the standard one , on the prevalence of acute postoperative infection in orthopedic surgery for acute and chronic disease of a thoracic and a pelvic limb .
METHODS	Prospective , observational , experimental randomized , double-blind trial in patients undergoing orthopedic surgery due to acute or chronic disease , between April and September 2009 .
METHODS	The sample size was determined using the formula to calculate the finite population .
METHODS	Two groups were formed : one was given cefalotin for 24 hours plus ten additional days of dicloxacillin , the standard regimen and a second one that received cefalotin for 24 hours and placebo for ten days .
METHODS	The wound was assessed during hospitalization and it was checked on days 5 , 8 , 14 and 30 .
METHODS	A statistical software was used for the statistical analysis , which included Student 's t-test and chi2 , and descriptive statistics for percentages , frequencies , means and standard deviations .
METHODS	The protocol was approved by the local health research committee .
RESULTS	One hundred and thirty-one patients were included .
RESULTS	Group I included 62 patients with cefalotin/dicloxacillin and Group II 69 patients with cafalotin/placebo for 10 days .
RESULTS	In Group I one patient had infection and in Group II there were 3 cases , with p = 0.50 when chi2 was applied .
CONCLUSIONS	Antimicrobial prophylaxis with 24 hour-cefalotin has the same effect on the prevalence of postoperative infection than a prolonged cycle of cefalotin plus dicloxacillin , according to the chi2 test .
CONCLUSIONS	It is clear that there is no considerable benefit in giving antibiotics indiscriminately and for long periods of time compared with protection from infection in clean wounds .

###24831754
BACKGROUND	In the multi-site Prescription Opioid Addiction Treatment Study ( POATS ) , conducted within the National Drug Abuse Clinical Trials Network , participants randomly assigned to receive individual drug counseling in addition to buprenorphine-naloxone and medical management did not have superior opioid use outcomes .
BACKGROUND	However , research with other substance-dependent populations shows that subgroups of participants may benefit from a treatment although the entire population does not .
METHODS	We conducted a secondary analysis of POATS data to determine whether a subgroup of participants benefited from drug counseling in addition to buprenorphine-naloxone and medical management , either due to greater problem severity or more exposure to counseling as a result of greater treatment adherence .
METHODS	Problem severity was measured by a history of heroin use , higher Addiction Severity Index drug composite score , and chronic pain .
METHODS	Adequate treatment adherence was defined a priori as attending at least 60 % of all offered sessions .
RESULTS	Patients who had ever used heroin and received drug counseling were more likely to be successful ( i.e. , abstinent or nearly abstinent from opioids ) than heroin users who received medical management alone , but only if they were adherent to treatment and thus received adequate exposure to counseling ( OR = 3.7 , 95 % CI = 1.1-11 .8 , p = 0.03 ) .
RESULTS	The association between severity and outcome did not vary by treatment condition for chronic pain or ASI drug severity score .
CONCLUSIONS	These findings emphasize the importance of treatment adherence , and suggest that patients with prescription opioid dependence are a heterogeneous group , with different optimal treatment strategies for different subgroups .

###24874911
BACKGROUND	The most effective approach for long-standing persistent atrial fibrillation ( LPAF ) ablation remained undetermined .
BACKGROUND	Our goal was to explore the heterogeneous left atrial substrate in patients with LPAF and to evaluate the effectiveness of a novel individualized substrate modification ( ISM ) approach in LPAF ablation .
METHODS	One hundred and twenty-four patients with LPAF were randomized to ISM group ( n = 64 ) or stepwise ablation ( SA ) group ( n = 60 ) .
METHODS	After pulmonary vein isolation , ISM was performed in the ISM group and SA was applied in the SA group .
METHODS	The clinical effectiveness after a single and a repeated procedure was compared .
RESULTS	The total procedural time was significantly shorter in ISM than that in SA .
RESULTS	In the ISM group , mild left atrial substrate was observed in 17 ( 27.4 % ) , moderate in 26 ( 41.9 % ) and severe in 19 ( 30.6 % ) patients after successful cardioversion of the 62 patients .
RESULTS	The intention-to-treat analysis showed that sinus rhythm was maintained in 65.5 % of patients in the ISM group and in 45.0 % of patients in the SA group after a single procedure , P = 0.04 .
RESULTS	Atrial tachycardia ( AT ) recurred in 5 of 22 in the ISM group and in 20 of 33 in the SA group , P = 0.01 .
RESULTS	After a repeated procedure , 75 % of patients in the ISM group and 63.3 % of patients in the SA group were free of further recurrence , P = 0.16 .
CONCLUSIONS	Left atrial substrate varied noticeably in patients with LPAF .
CONCLUSIONS	The ISM approach was superior to SA approach in terms of procedural time , recurrence rate of AT and clinical effectiveness after a single procedure .
CONCLUSIONS	However , they yielded comparable outcomes after a repeated procedure .

###24640583
BACKGROUND	Relaxin is a peptide hormone that exerts specific effects on cardiovascular system and human brain , leading to the hypothesis that this hormone may play a protective role against CVD and integration and modulation of behavioral activation .
BACKGROUND	We aimed to demonstrate the efficacy of Relaxin on functional recovery of post-stroke patients .
METHODS	Patients admitted within a Rehabilitation Unit suffering from stroke have been evaluated .
METHODS	Patients have been randomized to RLX ( 40 mcg/d ) plus rehabilitation vs a control group that underwent only rehabilitation .
METHODS	A preliminary analysis of 36 patients at 20 and 40 days was made using the mRS for global function , the Functional Independent Measure ( FIM ) for daily activity and Trail Making Test ( TMT ) for cognitive function .
RESULTS	Eighteen patients ( age 72 ( 64-79 ) , M 56 % ) randomized to RLX plus rehabilitation were compared to 18 patients ( age 68 ( 64-78 ) , M 50 % ) that underwent only rehabilitation .
RESULTS	There was no difference between the two groups in terms of risk factors , stroke syndromes and etiology .
RESULTS	At admission the two groups showed the same characteristics in terms of functional aspects ( mRS , FIM ; p ns ) and cognitive function ( TMT ; p ns ) .
RESULTS	After 20 days ( T1 ) the treatment group ( RLX + rehabilitation ) showed no differences between the two groups ( FIM 78 vs 69 ; p ns ) , while after 40 days ( T2 ) patients treated with RLX+R showed an excellent recovery ( FIM 96 vs 75 ; p0 .001 ) .
RESULTS	In terms of cognitive function patients RLX+R revealed a better performance at T1 ( TMT 3.5 vs 2 ; p 0.002 ) and still better at T2 ( TMT 4 vs 2 ; p 0.001 ) .
RESULTS	These results have been confirmed in terms of global function both at T1 ( mRS 2.5 vs 3 ; p0 .001 ) and T2 ( mRS 2 vs 3 ; p < 0.001 ) .
CONCLUSIONS	Relaxin showed in this analysis a positive effects on stroke patient 's recovery , thus offering the broad therapeutic potential role of RLX as new drug in post-stroke patients .

###24332238
BACKGROUND	Second-line chemotherapy for patients with oesophagogastric adenocarcinoma refractory to platinum and fluoropyrimidines has not shown benefits in health-related quality of life ( HRQoL ) .
BACKGROUND	We assessed whether the addition of docetaxel to active symptom control alone can improve survival and HRQoL for patients .
METHODS	For this open-labelled , multicentre trial , we recruited patients aged 18 years or older from 30 UK centres .
METHODS	Patients were eligible if they had an advanced , histologically confirmed adenocarcinoma of the oesophagus , oesophagogastric junction , or stomach that had progressed on or within 6 months of treatment with a platinum-fluoropyrimidine combination .
METHODS	Patients could have an Eastern Cooperative Oncology Group performance status of 0-2 .
METHODS	We randomly assigned patients using a central , computerised minimisation procedure to receive docetaxel plus active symptom control , or active symptom control alone ( 1:1 ; stratified by disease status , disease site , duration of response to previous chemotherapy , and performance status ) .
METHODS	Docetaxel was given at a dose of 75 mg/m ( 2 ) by intravenous infusion every 3 weeks for up to six cycles .
METHODS	The primary endpoint was overall survival , analysed by intention to treat .
METHODS	This is the report of the planned final analysis .
METHODS	This study is an International Standardised Randomised Controlled Trial , number ISRCTN13366390 .
RESULTS	Between April 21 , 2008 , and April 26 , 2012 , we recruited 168 patients , allocating 84 to each treatment group .
RESULTS	After a median follow-up of 12 months [ IQR 10-21 ] ) and 161 ( 96 % ) deaths ( 80 in the docetaxel group , 81 in the active symptom control group ) , median overall survival in the docetaxel group was 5.2 months ( 95 % CI 4.1-5 .9 ) versus 3.6 months ( 3.3-4 .4 ) in the active symptom control group ( hazard ratio 0.67 , 95 % CI 0.49-0 .92 ; p = 0.01 ) .
RESULTS	Docetaxel was associated with higher incidence of grade 3-4 neutropenia ( 12 [ 15 % ] patients vs no patients ) , infection ( 15 [ 19 % ] patients vs two [ 3 % ] patients ) , and febrile neutropenia ( six [ 7 % ] patients vs no patients ) .
RESULTS	Patients receiving docetaxel reported less pain ( p = 0.0008 ) and less nausea and vomiting ( p = 0.02 ) and constipation ( p = 0.02 ) .
RESULTS	Global HRQoL was similar between the groups ( p = 0.53 ) .
RESULTS	Disease specific HRQoL measures also showed benefits for docetaxel in reducing dysphagia ( p = 0.02 ) and abdominal pain ( p = 0.01 ) .
CONCLUSIONS	Our findings suggest that docetaxel can be recommended as an appropriate second-line treatment for patients with oesophagogastric adenocarcinoma that is refractory to treatment with platinum and fluoropyrimidine .
BACKGROUND	Cancer Research UK .

###24258250
OBJECTIVE	The purpose of this study was to identify characteristics of peer coaches associated with improvement in diabetes control among low-income patients with type 2 diabetes .
METHODS	Low-income patients with type 2 diabetes who spoke English or Spanish from 6 urban clinics in San Francisco , California , were invited to participate in the study .
METHODS	Twenty participants received training and provided peer coaching to 109 patients over a 6-month peer coaching intervention .
METHODS	Primary outcome was average change in patient glycosylated hemoglobin ( A1C ) .
METHODS	Characteristics of peer coaches included age , gender , years with diabetes , A1C , body mass index ( BMI ) , levels of diabetes-related distress , self-efficacy in diabetes self-management , and depression .
RESULTS	Patient improvement in A1C was associated with having a coach with a lower sense of self-efficacy in diabetes management ( P < .001 ) , higher level of diabetes-related distress ( P = .01 ) , and lower depression score ( P = .03 ) .
CONCLUSIONS	Coach characteristics are associated with patient success in improving A1C .
CONCLUSIONS	`` Better '' levels of coach diabetes self-efficacy and distress were not helpful and , in fact , were associated with less improvement in patient A1C , suggesting that some coach uncertainty about his or her own diabetes might foster improved patient self-management .
CONCLUSIONS	These coach characteristics should be considered when recruiting peer coaches .

###25809680
BACKGROUND	Although protein-rich plant foods have recently been touted as an equivalent to animal products , limited data exist regarding the effects of animal vs. plant proteins on appetite , satiety , and subsequent food intake .
OBJECTIVE	The objective was to determine whether a high-protein beef lunch alters the appetitive , hormonal , and neural signals controlling food intake regulation vs. a macronutrient and fiber-matched ( MF ) or serving size-matched ( SS ) soy lunch in healthy adults .
METHODS	A randomized , double-blind , crossover design study was completed in 21 adults ( aged 23 1 y ; body mass index : 23.8 0.6 kg/m ; mean SEM ) to compare 400-kcal MF and SS lunches varying in protein quality .
METHODS	The MF lunches contained 24-g beef protein or 24-g soy protein , whereas the SS lunches contained 1 serving of beef ( 24-g protein/1-g fiber ) or soy ( 14-g protein/5-g fiber ) .
METHODS	Pre - and postlunch appetite questionnaires and blood sampling were completed over an 8-h period until dinner was voluntarily requested .
METHODS	In addition , pre - and postlunch functional MRI brain scans were completed to assess neural activation in response to food stimuli .
RESULTS	On average , dinner was requested at 250 20 min postlunch with no differences between beef vs. soy within the MF and SS conditions .
RESULTS	Furthermore , no differences in hunger , fullness , peptide YY , or glucagon-like peptide-1 responses were observed after the beef vs. soy lunches within the MF and SS conditions .
RESULTS	The SS beef meal led to reductions in anterior cingulate activation ( -22 6 % ) vs. soy ( +7 9 % ; P < 0.01 ) and greater reductions in insular activation ( -30 6 % ) vs. SS soy ( -7 10 % ; P < 0.01 ) .
RESULTS	The participants consumed 945 78 kcal after the MF meals and 910 74 kcal after the SS meals with no differences between beef vs. soy .
CONCLUSIONS	When comparing 2 high-quality protein sources , such as beef and soy , the type of protein consumed within a mixed meal elicited very little effect on appetite , satiety , and food intake in healthy adults .

###24296814
BACKGROUND	Primary progressive aphasia ( PPA ) is an untreatable neurodegenerative disorder that disrupts language functions .
BACKGROUND	Previous studies have demonstrated transcranial direct current stimulation ( tDCS ) may improve language symptoms in patients with post stroke aphasia or neurodegenerative diseases .
OBJECTIVE	The present study investigated whether the application of anodal tDCS ( AtDCS ) to the scalp overlying the left dorsolateral prefrontal cortex ( DLPFC ) , which may increase cortical excitability , in combination with individualized speech therapy would improve naming accuracy in the agrammatic variant of PPA ( avPPA ) .
METHODS	Sixteen avPPA patients were randomly allocated into two subgroups : AtDCS ( n = 8 ) or placebo tDCS ( PtDCS ) .
METHODS	tDCS was applied over the left DLPFC ( BA 8/9 ) 25 minutes per day for two weeks ( 10 days ) .
METHODS	Each patient underwent 25 minutes of individualized speech therapy with either AtDCS or PtDCS during each treatment session .
METHODS	Neuropsychological assessment , experimental naming , and linguistic abilities in daily living were assessed at baseline ( T0 ) , after two weeks of intervention ( T1 ) and at a 12-week follow-up ( T2 ) .
RESULTS	Significant improvement in experimental naming was observed in both groups at T1 and T2 , but this effect was significantly greater in AtDCS than PtDCS patients .
RESULTS	Naming correctness , as assessed using the Aachener Aphasie Test , increased selectively in the AtDCS group from T0 to T1 , and this effect remained significant at T2 .
RESULTS	The analysis of daily living language abilities improved selectively in AtDCS group .
CONCLUSIONS	Our results support the beneficial effect of targeted language training in combination with brain stimulation in avPPA patients .
CONCLUSIONS	tDCS should be considered a useful tool for the improvement of language functions in patients with neurodegenerative diseases in future trials .

###24750301
OBJECTIVE	To evaluate transcutaneous electrical nerve stimulation ( TENS ) used to relieve uterine contraction pain during breast-feeding in multiparous women .
METHODS	A controlled and randomized clinical trial was performed with 32 post-partum multiparous women who were breast-feeding .
METHODS	The participants were randomized into an experimental ( EG , n = 16 ) and a control group ( CG , n = 16 ) .
METHODS	Pain was assessed using the Numerical Rating Scale and the descriptors of the Present Pain Intensity ( PPI - McGill ) during two sequential feeds .
METHODS	In the first assessment , the post-partum women in the EG and CG were monitored while breast-feeding and questioned regarding the degree of uterine contraction pain .
METHODS	In the second assessment , which was performed at the next feed , the EG used TENS while the CG was monitored , with pain being reassessed following .
METHODS	In the EG , the TENS electrodes were placed between T10-L1 and S2-S4 , with a frequency of 100 Hz , a pulse duration of 75 s and amplitude adjusted to produce a strong and tolerable sensation for 40 min .
METHODS	A descriptive analysis of the data and comparative intra - and intergroup analyses were performed by means of a non-parametrical test , with a significance level P 0.05 .
RESULTS	The level of basal pain was 5.56 in the EG and 5.50 in the CG .
RESULTS	In the intragroup analysis , the EG ( P < 0.0001 ) and CG ( P = 0.04 ) presented significant pain reduction .
RESULTS	In the intergroup analysis , the EG had significant pain reduction ( P < 0.01 ) in comparison to the CG .
RESULTS	In the PPI analysis , a non-significant decrease in pain intensity was observed in the EG .
CONCLUSIONS	TENS was found to be effective in reducing post-partum uterine contraction pain during breast-feeding .

###24572702
BACKGROUND	Cold-induced increases in aortic blood pressure ( BP ) may cause adverse cardiac events in hypertensives by increasing ventricular afterload .
BACKGROUND	L-citrulline supplementation reduces BP at baseline and during the cold pressor test ( CPT ) , but the effect on wave reflection ( augmentation pressure ( AP ) and index ( AIx ) ) is controversial .
BACKGROUND	Our aim was to assess the effect of L-citrulline-rich watermelon supplementation on aortic hemodynamic responses to CPT in hypertensive adults .
METHODS	Brachial systolic BP ( bSBP ) and aortic systolic BP ( aSBP ) , AP , AIx , AIx adjusted to 75 beats/min ( AIx75 ) , reflection time ( Tr ) , first ( P1 ) and second systolic peak ( P2 ; wave reflection magnitude ) , heart rate ( HR ) , and systolic time index ( STI ; myocardial oxygen demand ) at baseline and during CPT and magnitude of the response from baseline to CPT were evaluated in 13 individuals ( 10 women ; 571 year ; bSBP 1515 mm Hg ) .
METHODS	Participants were randomized to a 6-week watermelon or placebo supplementation in a crossover design .
RESULTS	Watermelon reduced ( P < 0.05 ) bSBP , aSBP , P1 , and P2 at baseline and CPT compared with placebo ; thus , increases from baseline to CPT were unaffected .
RESULTS	Watermelon did not affect AP , AIx , AIx75 , and STI at baseline but decreased ( P < 0.05 ) AP and STI during CPT and the increases in AP ( ~ 5mm Hg ) and AIx75 ( ~ 7.3 % ) from baseline to CPT .
CONCLUSIONS	Watermelon supplementation reduced aortic BP and myocardial oxygen demand during CPT and the magnitude of the cold-induced increase in wave reflection in obese adults with hypertension .
CONCLUSIONS	Watermelon may provide cardioprotection by attenuating cold-induced aortic hemodynamic responses .
BACKGROUND	Clinicaltrial.gov register , NCT01185041 .

###24286284
OBJECTIVE	The aim of this study is to determine whether laparoscopic repair ( LR ) of inguinal hernia is superior to open repair ( OR ) in bilateral cases .
METHODS	Sixty-two boys older than 6 years with bilateral hernias were included in our prospective , randomized , single-blinded clinical trial .
METHODS	All patients were administered morphine via patient-controlled analgesia for 24 hours .
METHODS	Pain scores were evaluated by the patients using a visual analog scale ( VAS ) at 1 , 2 , 4 , 12 , and 24 hours postoperatively .
METHODS	Operative time , pain scores , analgesic doses , and first mobilization attempt were evaluated .
METHODS	Parents also provided assessments of their children 's recovery and wound appearance .
RESULTS	Operative time was found to be slightly higher in OR compared with LR .
RESULTS	VAS scores were higher in OR than in LR at 1 hour postoperatively ( 6.78 versus 3.88 , respectively ; P < .05 ) .
RESULTS	At the other times , VAS scores showed no significant differences .
RESULTS	Although OR patients requested and delivered analgesics more frequently than LR patients , the difference was not significant .
RESULTS	The scores given by parents for wound appearance were significantly higher in the bilateral LR group than in the bilateral OR group ( 894.23 and 786.7 , respectively ; P < .05 ) .
CONCLUSIONS	This trial demonstrates that LR in bilateral cases offers benefits compared with OR in terms of lower pain scores and analgesic requirements and of reduced operative and patient recovery times .
CONCLUSIONS	However , the only significant difference was better wound cosmesis in bilateral LR cases .

###25514077
OBJECTIVE	The purpose of this randomized , controlled , crossover clinical trial was to evaluate and compare the behavioral differences resulting from the sedative effects of atomized buccal ( transmucosal ) and atomized intranasal ( parenteral ) midazolam ( 0.3 mg/kg ) as a method for sedation of pediatric dental patients .
METHODS	Twenty-five 36 - to 72-month-old patients were randomly selected and divided into two groups that were sedated with either atomized buccal in the first visit or intranasal midazolam in the second visit ( 0.3 mg/kg ) .
METHODS	Patient be - havior was rated , and drug acceptance by method of administration was determined .
RESULTS	There were no statistically significant differences between both groups in maximum working time .
RESULTS	There were significant differences between both groups in drug acceptance ( P = .008 ) and onset time ( P = .00 ) .
RESULTS	The statistical differences between the two groups were not significant in all behavior rating scales , except for the crying rating scale , since the buccal group showed more crying .
CONCLUSIONS	Atomized buccal and intranasal midazolam are both effective for sedation of pediatric dental patients and have the same maximum working time .
CONCLUSIONS	However , atomized intranasal is more acceptable by children , has faster onset time , and children demonstrate less crying .

###24655007
BACKGROUND	Both the amount and the rate of absorption of ethanol ( EtOH ) from alcoholic beverages are key determinants of the peak blood alcohol concentration ( BAC ) and exposure of organs other than gut and liver .
BACKGROUND	Previous studies suggest EtOH is absorbed more rapidly in the fasting than in the postprandial state .
BACKGROUND	The concentration of EtOH and the type of beverage may determine gastric emptying/absorption of EtOH .
METHODS	The pharmacokinetics of EtOH were measured in 15 healthy men after consumption of 0.5 g of EtOH/kg body weight .
METHODS	During this 3-session crossover study , subjects consumed in separate sessions , beer ( 5.1 % v/v ) , white wine ( 12.5 % v/v ) , or vodka/tonic ( 20 % v/v ) over 20 minutes following an overnight fast .
METHODS	BAC was measured by gas chromatography at multiple points after consumption .
RESULTS	Peak BAC ( Cmax ) was significantly higher ( p < 0.001 ) after vodka/tonic ( 77.4 17.0 mg/dl ) than after wine ( 61.7 10.8 mg/dl ) or beer ( 50.3 9.8 mg/dl ) and was significantly higher ( p < 0.001 ) after wine than beer .
RESULTS	The time to Cmax occurred significantly earlier ( p < 0.01 ) after vodka/tonic ( 36 10 minutes ) compared to wine ( 54 14 minutes ) or beer ( 62 23 minutes ) .
RESULTS	Six subjects exceeded a Cmax of 80 mg/dl after vodka/tonic , but none exceeded this limit after beer or wine .
RESULTS	The area under the concentration-time curve ( AUC ) was significantly greater after drinking vodka/tonic ( p < 0.001 ) than after wine or beer .
RESULTS	Comparison of AUCs indicated the relative bioavailability of EtOH was lower after drinking beer .
CONCLUSIONS	Findings indicate that BAC is higher after drinking vodka/tonic than beer or wine after fasting .
CONCLUSIONS	A binge pattern is significantly more likely to result in BAC above 80 mg/dl after drinking vodka/tonic than beer or wine .
CONCLUSIONS	Men drinking on an empty stomach should know BAC will vary depending on beverage type and the rate and amount of EtOH .

###24356256
BACKGROUND	This study was conducted to determine whether treatment with motavizumab , an anti-respiratory syncytial virus ( RSV ) monoclonal antibody , would decrease viral load and improve clinical outcomes in previously healthy term infants hospitalized with RSV lower respiratory tract infection .
METHODS	Infants hospitalized with lower respiratory tract infection and a positive RSV test performed locally were randomized to receive 1 intravenous dose of motavizumab ( 30 or 100 mg/kg ) or placebo .
METHODS	Nasal wash samples were tested by real-time reverse transcriptase polymerase chain reaction at a central laboratory to determine viral load .
METHODS	Clinical data were collected during RSV hospitalization and at 12-month follow up .
RESULTS	Of 118 infants , 112 were confirmed RSV positive by real-time reverse transcriptase polymerase chain reaction .
RESULTS	In each study group , median ( range ) RSV load ( log10 copies/mL ) decreased at a similar rate from baseline to study day 7 [ motavizumab 30 mg/kg : 8.35 ( 2.5-9 .5 ) to 5.03 ( 2.5-6 .8 ) ; motavizumab 100 mg/kg : 8.22 ( 5.5-9 .7 ) to 4.25 ( 2.5-8 .0 ) ; placebo : 8.02 ( 6.7-9 .8 ) to 5.17 ( 2.5-7 .3 ) ] .
RESULTS	Median ( range ) duration of hospitalization was 3.05 ( 0.8-16 .0 ) , 2.99 ( 1.0-25 .0 ) and 2.88 ( 0.8-11 .7 ) days for the motavizumab 30 mg/kg , motavizumab 100 mg/kg and placebo groups , respectively .
RESULTS	Six ( 8 % ) motavizumab and 0 placebo recipients were admitted to the intensive care unit and 4 required mechanical ventilation .
RESULTS	The incidence of wheezing episodes during the 12-month follow up was comparable for all 3 groups .
CONCLUSIONS	Motavizumab had no appreciable effect on RSV viral load measured in the upper respiratory tract of children hospitalized for RSV lower respiratory tract infection .
CONCLUSIONS	No differences were observed for duration of hospitalization , severity of illness measures or wheezing episodes during 12-month follow up in children treated with motavizumab or placebo .

###25131129
BACKGROUND	New-onset diabetes after transplantation ( NODAT ) is one of the most common complications after kidney transplantation .
METHODS	Patients were randomly assigned to receive cyclosporine A-based or tacrolimus-based immunosuppression .
METHODS	Fasting and oral glucose tolerance tests were performed , and the patients were assigned to one of the following 3 groups , on the basis of the results : normal , impaired fasting glucose/impaired glucose tolerance , or NODAT .
METHODS	NODAT developed in 14 % of patients receiving cyclosporine A-based immunosuppression and in 26 % of patients taking tacrolimus ( P = .0002 ) .
RESULTS	Albumin levels were similar , but uric acid level ( P = .002 ) and the age of the recipient ( P = .003 ) were significantly different between the diabetic and the normal groups .
RESULTS	Evaluation of tissue samples revealed that acute cellular rejection and interstitial fibrosis/tubular atrophy were significantly different in the NODAT group .
RESULTS	Changes in the Banff score provided significant difference regarding tubulitis and interstitial inflammation ( P = .05 ) .
CONCLUSIONS	The pathological effect of new-onset diabetes after kidney transplantation can be detected in the morphology of the renal allograft earlier , before the development of any sign of functional impairment .

###24373376
OBJECTIVE	To compare the visual and refractive outcomes and the corneal structural changes in myopic patients after surface refractive treatments ( ie , photorefractive keratectomy [ PRK ] with adjuvant mitomycin-C [ MMC ] and epithelial laser in situ keratomileusis [ epi-LASIK ] ) .
METHODS	University of Crete , Heraklion , Crete , Greece .
METHODS	Prospective comparative case series .
METHODS	One eye of consecutive myopic patients was randomly assigned to PRK-MMC , and the fellow eye was treated with epi-LASIK .
METHODS	Visual and refractive outcomes and corneal confocal microscopy findings were evaluated .
METHODS	All patients were examined preoperatively and 1 , 3 , 6 , 12 , and 24 months postoperatively .
RESULTS	Twenty-six eyes ( 13 patients ) were included .
RESULTS	The mean follow-up was 2.47 years 0.35 ( SD ) ( range 1.64 to 2.93 years ) .
RESULTS	In the PRK-MMC group , the mean preoperative spherical equivalent refraction was -3.84 1.59 diopters ( D ) ( range -1.5 to -8.7 D ) and -0.21 0.44 D ( range -0.5 to 1.0 D ) at the last follow-up and in the epi-LASIK group , -3.91 1.48 D ( range -1.5 to -8.5 D ) and -0.18 0.36 ( range +0.5 to -0.5 D ) , respectively .
RESULTS	Qualitative analysis of the subepithelial nerve plexus , haze development , and keratocyte distribution were similar in the 2 groups .
RESULTS	There was no statistically significant difference in endothelial cell density between the groups throughout the follow-up ( P > .05 ) .
CONCLUSIONS	Epithelial LASIK and PRK-MMC gave similar visual , refractive , and corneal structural outcomes in patients with myopia for up to 2 years postoperatively .
BACKGROUND	No author has a financial or proprietary interest in any material or method mentioned .

###25291578
OBJECTIVE	The need to respond quickly to potential influenza pandemics is important .
OBJECTIVE	Immunologic priming ( initial presentation of an antigen to allow antibody responses on revaccination ) with vaccine directed toward an older avian influenza H5 strain might lead to secondary antibody responses to a single dose of more current H5 avian influenza vaccine .
OBJECTIVE	To assess priming with the older avian influenza A/Vietnam/1203 / 2004 ( H5N1 ) ( Vietnam ) vaccine and to conduct dose-response studies with vaccine directed against the more contemporary H5N1 avian influenza virus , influenza A/Anhui/01 / 2005 ( Anhui ) .
METHODS	Multicenter US randomized clinical trial beginning in June 2010 with follow-up continuing through October 2011 enrolling 72 healthy adults who were vaccinated 1 year previously with the Vietnam vaccine and 565 vaccine-naive adults .
METHODS	Participants who were previously vaccinated with 90 g of unadjuvanted Vietnam vaccine were randomly assigned to receive 3.75 g of avian influenza Anhui vaccine with or without MF59 adjuvant , stratified by 1 vs 2 previous doses ( 1 dose : n = 18 with MF59 and n = 17 without ; 2 doses : n = 19 with MF59 and n = 18 without ) .
METHODS	Vaccine-naive individuals were randomly assigned to receive Ahnui vaccine with or without MF59 adjuvant in 1 of 5 doses ( 3.75 g [ n = 55 with MF59 and n = 59 without ] , 7.5 g [ n = 51 with MF59 and n = 57 without ] , 15 g [ n = 48 with MF59 and n = 44 without ] , 45 g [ n = 47 with MF59 and n = 47 without ] , or 90 g [ n = 57 without adjuvant ] ) or placebo ( n = 100 ) given at days 0 and 28 .
METHODS	The primary immunogenicity outcome was hemagglutination inhibition assay ( HAI ) titer against each vaccine antigen 1 month ( day 28 ) and 6 months ( day 180 ) after last vaccination .
METHODS	The primary safety outcomes were local and systemic adverse events on days 0 to 7 after each vaccination and serious adverse events .
RESULTS	Previously vaccinated participants manifested secondary antibody responses after receipt of low-dose Anhui vaccine ( `` boosting '' ) ; by day 28 , 21 % to 50 % developed HAI responses of 1:40 or greater .
RESULTS	Use of adjuvant was not associated with increased HAI responses .
RESULTS	Among vaccine-naive participants ( n = 565 ) , the optimum dose was 7.5 g of antigen with adjuvant ( geometric mean titer [ GMT ] , 63.3 ; 95 % CI , 43.0-93 .1 ) .
RESULTS	The greatest response to unadjuvanted antigen was seen at the highest dose , 90 g ( GMT , 28.5 ; 95 % CI , 19.7-41 .2 ) .
RESULTS	Local or systemic reactions occurred , respectively , in 40 ( 78 % ) and 25 ( 49 % ) of 51 participants who received 7.5 g plus adjuvant vs 50 ( 88 % ) and 29 ( 51 % ) of 57 who received 90 g of unadjuvanted vaccine .
RESULTS	In general , antibodies were short-lived , and by day 180 , HAI titers had decreased to less than 1:20 in all treatment groups .
CONCLUSIONS	Previous receipt of a single dose of influenza A ( H5N1 ) Vietnam vaccine was associated with sufficient immunologic priming to facilitate antibody response to a different H5N1 antigen using low-dose Anhui ( booster ) vaccine .
CONCLUSIONS	In participants who had not previously received H5 vaccine , low-dose Anhui vaccine plus adjuvant was more immunogenic compared with higher doses of unadjuvanted vaccine .
BACKGROUND	clinicaltrials.gov Identifier : NCT00680069 .

###25664620
OBJECTIVE	Most patients with asthma take fewer than half of prescribed doses of controller medication .
OBJECTIVE	Interventions to improve adherence have typically been costly , impractical , and at best only minimally successful .
OBJECTIVE	To test a speech recognition ( SR ) intervention to improve adherence to pediatric asthma controller medication .
METHODS	The Breathe Well study was a 24-month pragmatic randomized clinical trial .
METHODS	The study was conducted within Kaiser Permanente Colorado , a large , group-model health maintenance organization .
METHODS	A total of 1187 children aged 3 to 12 years with a persistent asthma diagnosis and prescription for an inhaled corticosteroid were randomized to the computerized SR intervention or usual care condition and followed up for 24 months between October 2009 and February 2013 .
METHODS	Speech recognition telephone calls to parents in the intervention condition were triggered when an inhaled corticosteroid refill was due or overdue .
METHODS	Calls were automatically tailored with medical and demographic information from the electronic health record and from parent answers to questions in the call regarding recent refills or a desire to receive help refilling , learn more about asthma control , or speak with an asthma nurse or pharmacy staff member .
METHODS	Adherence to pediatric asthma controller medication , measured as the medication possession ratio over 24 months .
RESULTS	In the intention-to-treat analysis , inhaled corticosteroid adherence was 25.4 % higher in the intervention group than in the usual care group ( 24-month mean [ SE ] adherence , 44.5 % [ 1.2 % ] vs 35.5 % [ 1.1 % ] , respectively ; P < .001 ) .
RESULTS	Asthma-related urgent care events did not differ between the 2 groups .
RESULTS	The intervention effect was consistent in subgroups stratified by age , sex , race/ethnicity , body mass index , and disease-related characteristics .
CONCLUSIONS	The intervention 's significant impact on adherence demonstrates strong potential for low-cost SR adherence programs integrated with an electronic health record .
CONCLUSIONS	The absence of change in urgent care visits may be attributable to the already low number of asthma urgent care visits within Kaiser Permanente Colorado .
CONCLUSIONS	Application of electronic health record-leveraged SR interventions may reduce health care utilization when applied in a population with less-controlled asthma .
BACKGROUND	clinicaltrials.gov Identifier : NCT00958932 .

###24886348
BACKGROUND	Whether acupuncture is effective for relieving perimenopausal syndrome has been controversial recently .
BACKGROUND	In this article , we report the protocol of a randomized controlled trial using acupuncture to treat perimenopausal syndrome , aiming to answer this controversy .
METHODS	A multicenter randomized controlled trial with two parallel arms is underway in China .
METHODS	Two hundred and six women with perimenopausal syndrome will be randomly assigned to a treatment group using acupuncture plus auricular acupressure ( AA group ) and a control group using Climen ( Bayer Healthcare Company Limited , Guangzhou , China ) , a 28-day sequential hormone replacement therapy , in a 1:1 ratio .
METHODS	Participants in the AA group will receive three acupuncture sessions per week in the first 4 weeks and two sessions per week in the following 8 weeks , for a total of 28 sessions over 12 weeks .
METHODS	Auricular points will be plastered by Semen Vaccariae twice per week for a consecutive 12 weeks , with both ears used alternately .
METHODS	The Climen control group is prescribed a tablet containing estradiol valerate 2 mg/day for the first 11 days , and a tablet containing estradiol valerate 2 mg/day plus cyroterone acetate 1 mg/day for the following 10 days .
METHODS	The total treatment period of the control group is three cycles .
METHODS	The post-treatment follow-up period will last 24 weeks .
METHODS	The primary outcome is the Menopause Rating Scale ( MRS ) assessed at baseline and 4 , 12 , 16 , 24 and 36 weeks after randomization .
METHODS	The secondary outcomes are Menopause-Specific Quality of Life , average hot flash score during 24 hours , serum estradiol , follicle-stimulating hormone and luteinizing hormone level .
METHODS	The first two secondary outcomes are measured at the same point as the MRS. Other secondary outcomes are measured at baseline and 12 , 24 weeks after randomization .
CONCLUSIONS	The results of this trial , which will be available in 2015 , will clarify whether acupuncture is effective to relieve perimenopausal syndrome .
BACKGROUND	ClinicalTrials.gov NCT01933204 ( registered 9 August 2013 ) .

###24290977
BACKGROUND	Carpal tunnel decompression with division of the transverse carpal ligament has been a highly successful procedure for the treatment of carpal tunnel syndrome .
BACKGROUND	The standard longitudinal incision technique , with a long curvilinear incision , has been the optimal treatment procedure for surgical decompression of the median nerve , for many surgeons .
BACKGROUND	The aim of this study was to compare the traditional open carpal tunnel release ( TOCTR ) technique with the minimal-access carpal tunnel release ( MACTR ) technique for the treatment of carpal tunnel syndrome ( CTS ) , presenting our experience .
METHODS	A total of 120 patients eligible for carpal tunnel decompression were recruited into the study .
METHODS	The patients were randomised for treatment allocation , at a 1:1 ratio , resulting in 60 patients in group A , treated by standard TOCTR , and 60 patients in group B , treated by MACTR .
METHODS	To evaluate patients ' outcomes we used the Boston Carpal Tunnel ( BCT ) questionnaire ; the formed scar was evaluated according to the Vancouver scale and short - and long-term complications .
METHODS	Statistical analysis was performed by the chi-squared test and analysis of variance ( ANOVA ) ; Excel was the program used .
RESULTS	In our series , there was no complication related to the surgical intervention of any injury to nerve , artery or tendon structures .
RESULTS	In each section of the BCT questionnaire , patients in group B had significantly better results than patients in group A at both 6 and 12 months ' follow-up ( p < 0.001 ) .
RESULTS	For the Vancouver scar scale , there was a significant difference between two groups ' scores ; group B patients had significant improvements compared with group A patients .
CONCLUSIONS	In our perspective randomised study , MACTR showed statistically significant improvement compared to TOCTR .
CONCLUSIONS	The patient tolerance is reasonably high and the procedure is compatible with the current minimal invasive trend in surgery .

###24351079
OBJECTIVE	To investigate the efficacy and safety of a bilayer combination oxycodone ( OC ) and acetaminophen ( APAP ) analgesic with both immediate-release and extended-release ( ER ) components ( OC/APAP ER ) in patients with moderate to severe pain using an established acute pain model .
METHODS	This was a randomized , double-blind , placebo-controlled trial .
METHODS	Adult patients were included in the study if they had a pain intensity score4 on a 0-10 numerical rating scale after bunionectomy surgery , and were randomized ( 1:1 ) to receive four doses ( two tablets q12h ) of OC/APAP ER or placebo .
BACKGROUND	NCT01484652 .
METHODS	The primary efficacy endpoint was the summed pain intensity difference over the first 48 hours ( SPID48 ) .
METHODS	Secondary endpoints included SPIDs and total pain relief ( TOTPAR ) over the dosing intervals ; time to perceptible , meaningful , and confirmed pain relief ; and the proportion of patients with 30 % reduction in pain intensity scores .
RESULTS	A total of 329 patients were enrolled , of whom 266 ( OC/APAP ER , n = 135 ; placebo , n = 131 ) completed the study .
RESULTS	The mean ( SE ) SPID48 was 114.9 ( 7.6 ) in the OC/APAP ER group and 66.9 ( 7.6 ) in the placebo group ( P < 0.0001 ) .
RESULTS	SPID and TOTPAR values were significantly greater with OC/APAP ER than with placebo over all time periods analyzed , and the median times to perceptible , meaningful , and confirmed pain relief were significantly shorter .
RESULTS	More patients showed 30 % reduction in pain intensity scores with OC/APAP ER than with placebo at all times after 0.5 hours .
RESULTS	OC/APAP ER was generally well tolerated .
RESULTS	A limitation of this study was the lack of an active comparator .
CONCLUSIONS	OC/APAP ER was efficacious and generally well tolerated in an established model of moderate to severe acute pain , providing an onset of analgesia in approximately 30 minutes and sustained pain relief over the 12 hour dosing period .

###25869389
OBJECTIVE	Double-blind study comparing efficacy and safety of the topically acting corticosteroid beclomethasone dipropionate ( BDP ) to prednisone ( PD ) in patients with active , mild-to-moderate ulcerative colitis ( UC ) .
METHODS	Overall , 282 patients were randomized to receive BDP-prolonged release tablets 5mg once daily for 4 weeks and then every other day for an additional 4 weeks or oral PD 40mg once daily for the initial 2 weeks tapered of 10mg every 2 weeks during the 8-week study period .
METHODS	Efficacy end point was the non-inferiority of BDP vs. PD in terms of Disease Activity Index ( DAI ) score < 3 or reduction by at least 3 points for patients with a baseline DAI 7 at week 4 .
METHODS	Safety end point was the proportion of patients with steroid-related adverse events ( AEs ) and cortisol < 150nmol/l at week 4 .
RESULTS	DAI response rates at week 4 were 64.6 % and 66.2 % with BDP and PD , respectively , demonstrating non-inferiority of BDP vs. PD ( delta : -1.56 ; 95 % confidence interval ( CI ) -13.00 -9.88 , P = 0.78 ) .
RESULTS	Patients with steroid-related AEs and cortisol < 150nmol/l at week 4 were 38.7 % in the BDP group and 46.9 % in the PD group ( P = 0.17 between groups ) .
RESULTS	No safety signals were observed in both the groups .
CONCLUSIONS	BDP was non-inferior to PD in the treatment of active UC , with a good safety profile in both the groups .

###24567309
BACKGROUND	Micronutrient deficiencies and in utero exposure to HIV may impair infant neurodevelopment .
OBJECTIVE	To evaluate the effect of daily multivitamin supplementation on the cognitive , language and motor development of HIV-exposed Tanzanian infants .
METHODS	A total of 2387 infants were randomized to receive daily oral supplementation of multivitamins ( B-complex , C and E ) or placebo from age 6 weeks for 24 months .
METHODS	The cognitive , language and motor scales of the Bayley Scales of Infant and Toddler Development , third edition , were administered to a subset of 206 infants at age 15 months .
RESULTS	Multivitamin supplementation did not improve measures of cognitive development , expressive or receptive language or gross motor capabilities .
RESULTS	There was a trend toward improved fine motor skills among infants randomized to the multivitamin group ( difference in mean score = 0.38 ; 95 % CI = -0.01 , 0.78 , p = 0.06 ) .
CONCLUSIONS	Daily provision of multivitamins to HIV-exposed infants does not substantially improve developmental outcomes at age 15 months .

###24462315
BACKGROUND	Laparoscopic Roux-en-Y gastric bypass ( LRYGB ) is the most effective treatment for morbid obesity .
BACKGROUND	The additional benefit of placing a nonadjustable band around the pouch remains to be determined .
BACKGROUND	The objective of this study was to compare outcomes between banded and nonbanded LRYGB patients in a single bariatric center .
METHODS	A matched cohort analysis was performed between patients who had undergone banded and nonbanded ( standard ) LRYGB .
METHODS	In the banded bypass cohort , an 8 F , 6.5 cm silastic ring was placed around the proximal gastric pouch .
METHODS	Both cohorts were matched for age , body mass index ( BMI ) , and anastomotic technique .
METHODS	Endpoints included percentage excess weight loss ( % EWL ) , postoperative morbidity , and band-related complications .
RESULTS	Between January 2007 and July 2010 , 134 banded LRYGB were performed ( 55 % female , mean age 45 years ) .
RESULTS	They were compared with a matched cohort of 134 concurrent nonbanded LRYGB patients ( 67 % female , mean age 45.4 years ) .
RESULTS	Mean preoperative BMI was 54.6 and 52.8 kg/m ( 2 ) , respectively ( P = .084 ) .
RESULTS	At 24 months postoperatively , the average % EWL was 58.6 % in banded bypass patients and 51.4 % in the nonbanded group ( P = .015 ) .
RESULTS	The difference in EWL was more pronounced in super-obese patients than in those with BMI < 50 ( among super-obese , 57.5 % versus 47.6 % , P = .003 ; among those with BMI < 50 , 62.9 % versus 57.9 % , P = .406 ] .
RESULTS	There was no difference in early ( 19.4 % versus 19.4 % ) or late complications ( 10.4 % versus 13.4 % , P = .451 ) between banded and nonbanded LRYGB patients .
CONCLUSIONS	Banding the pouch during LRYGB can be performed safely and may provide better weight loss , particularly in super-obese patients .
CONCLUSIONS	Further prospective and long-term comparative studies of this technique are warranted .

###25989270
BACKGROUND	The mitogen-activated protein kinase ( MAPK ) pathway has been implicated in the molecular pathogenesis of human cancers , including metastatic colorectal cancer ( mCRC ) .
BACKGROUND	This provides a rationale for the development of MAPK-targeted agents such as pimasertib .
METHODS	Patients with KRAS mutant mCRC were treated in the second-line setting with FOLFIRI ( 5-fluorouracil/folinic acid/irinotecan ) plus pimasertib .
METHODS	The primary objective of the safety run-in phase was to determine the maximum-tolerated dose ( MTD ) and the recommended phase II dose of pimasertib combined with FOLFIRI .
RESULTS	Sixteen patients were enrolled in the trial .
RESULTS	Ten and six patients were treated daily with 45 and 60mg of pimasertib plus FOLFIRI , respectively .
RESULTS	The MTD was considered to be 45mg per day .
RESULTS	The most common treatment-emergent adverse events were diarrhoea , nausea , vomiting , asthenia and skin/rash event .
RESULTS	Of the 15 patients in the efficacy analysis group , two patients had partial response , nine patients had stable disease , three patients had progressive disease as their best overall response and one patient could not be evaluated .
CONCLUSIONS	Dose escalation of pimasertib in combination with FOLFIRI was limited by toxicity .
CONCLUSIONS	At the MTD of 45mg per day , pimasertib was adequately tolerated in patients with mCRC and no unexpected or new safety signals or concerns were identified .

###25536256
OBJECTIVE	Maternal micronutrient deficiencies may adversely affect fetal and infant health , yet there is insufficient evidence of effects on these outcomes to guide antenatal micronutrient supplementation in South Asia .
OBJECTIVE	To assess effects of antenatal multiple micronutrient vs iron-folic acid supplementation on 6-month infant mortality and adverse birth outcomes .
METHODS	Cluster randomized , double-masked trial in Bangladesh , with pregnancy surveillance starting December 4 , 2007 , and recruitment on January 11 , 2008 .
METHODS	Six-month infant follow-up ended August 30 , 2012 .
METHODS	Surveillance included 127,282 women ; 44,567 became pregnant and were included in the analysis and delivered 28,516 live-born infants .
METHODS	Median gestation at enrollment was 9 weeks ( interquartile range , 7-12 ) .
METHODS	Women were provided supplements containing 15 micronutrients or iron-folic acid alone , taken daily from early pregnancy to 12 weeks postpartum .
METHODS	The primary outcome was all-cause infant mortality through 6 months ( 180 days ) .
METHODS	Prespecified secondary outcomes in this analysis included stillbirth , preterm birth ( < 37 weeks ) , and low birth weight ( < 2500 g ) .
METHODS	To maintain overall significance of = .05 , a Bonferroni-corrected = .01 was calculated to evaluate statistical significance of primary and 4 secondary risk outcomes ( .05 / 5 ) .
RESULTS	Among the 22,405 pregnancies in the multiple micronutrient group and the 22,162 pregnancies in the iron-folic acid group , there were 14,374 and 14,142 live-born infants , respectively , included in the analysis .
RESULTS	At 6 months , multiple micronutrients did not significantly reduce infant mortality ; there were 764 deaths ( 54.0 per 1000 live births ) in the iron-folic acid group and 741 deaths ( 51.6 per 1000 live births ) in the multiple micronutrient group ( relative risk [ RR ] , 0.95 ; 95 % CI , 0.86-1 .06 ) .
RESULTS	Multiple micronutrient supplementation resulted in a non-statistically significant reduction in stillbirths ( 43.1 vs 48.2 per 1000 births ; RR , 0.89 ; 95 % CI , 0.81-0 .99 ; P = .02 ) and significant reductions in preterm births ( 18.6 vs 21.8 per 100 live births ; RR , 0.85 ; 95 % CI , 0.80-0 .91 ; P < .001 ) and low birth weight ( 40.2 vs 45.7 per 100 live births ; RR , 0.88 ; 95 % CI , 0.85-0 .91 ; P < .001 ) .
CONCLUSIONS	In Bangladesh , antenatal multiple micronutrient compared with iron-folic acid supplementation did not reduce all-cause infant mortality to age 6 months but resulted in a non-statistically significant reduction in stillbirths and significant reductions in preterm births and low birth weight .
BACKGROUND	clinicaltrials.gov Identifier : NCT00860470 .

###25001159
OBJECTIVE	To describe the systemic pharmacokinetics of ranibizumab after intravitreal administration in patients with retinal vein occlusion ( RVO ) or diabetic macular edema ( DME ) .
METHODS	A population approach of nonlinear mixed-effect pharmacokinetics modeling based on serum concentrations of ranibizumab measured at various times after intravitreal administration .
METHODS	Patients with RVO ( n = 441 ) and DME ( n = 435 ) from 4 large , randomized , phase 3 clinical trials of monthly ranibizumab intravitreal administration .
METHODS	A 1-compartment pharmacokinetics model with first-order absorption and elimination rate constants previously developed in patients with age-related macular degeneration ( AMD ) was fitted separately to RVO and DME data .
METHODS	Population pharmacokinetic parameters and interindividual variability were estimated for each model .
METHODS	Baseline covariates were evaluated for potential effects on systemic pharmacokinetics .
METHODS	Model performance was validated using general diagnostic plots and a visual predictive check .
METHODS	Ranibizumab disposition was determined in RVO and DME patients and compared with that previously seen in AMD patients .
RESULTS	The AMD pharmacokinetics model correctly predicted the measured serum ranibizumab concentration data for RVO and DME patients .
RESULTS	Most observed data points were within the simulated 90 % confidence interval , indicating that systemic ranibizumab concentrations were comparable among AMD , RVO , and DME patients .
RESULTS	No disease-related covariates were identified by the population pharmacokinetics analysis .
CONCLUSIONS	The systemic pharmacokinetics of ranibizumab were similar among patients with AMD , RVO , or DME .
CONCLUSIONS	Disease-related differences and patient demographics , measured in this study , did not lead to variability in ocular elimination or in systemic exposure of ranibizumab after intravitreal administration .
CONCLUSIONS	In all disease processes tested , ranibizumab exits the eye slowly and then is eliminated rapidly from the circulation , thus minimizing systemic exposure .

###24558091
OBJECTIVE	WAKE-UP is a randomized , placebo-controlled MRI-based trial of thrombolysis in wake-up stroke using the mismatch between a lesion 's visibility in diffusion-weighted imaging and fluid-attenuated inversion recovery ( FLAIR ) sequences as its main imaging inclusion criterion .
OBJECTIVE	Visual judgment of lesion conspicuity on FLAIR is however methodically limited by moderate inter-rater agreement .
OBJECTIVE	We therefore sought to improve rating homogeneity by incorporating quantitative signal intensity measurements .
METHODS	One hundred forty-three data sets of patients with acute ischemic stroke were visually rated by 8 raters with respect to WAKE-UP study inclusion and exclusion criteria , and inter-rater agreement was calculated .
METHODS	A subanalysis was performed on 45 cases to determine a threshold value of relative signal intensity ( rSI ) between the ischemic lesion and contralateral healthy tissue which best corresponded to a visually established verdict of FLAIR positivity .
METHODS	The usefulness of this threshold in improving inter-rater agreement was evaluated in an additional sample of 50 patients .
RESULTS	Inter-rater agreement for inclusion into the WAKE-UP trial was 73 % with a free-marginal of 0.46 .
RESULTS	A threshold of rSI which best correlated with the visual rating of lesions as FLAIR positive was 1.20 .
RESULTS	The addition of rSI measurements to visual evaluation did not change the inter-rater agreement .
CONCLUSIONS	Introducing a semiquantitative measure for FLAIR rSI did not improve the agreement between individual raters .
CONCLUSIONS	However , enhancing visual assessment with rSI measurements can provide reassurance to local investigators in cases of uncertainty .

###25311593
OBJECTIVE	Twenty-four weeks of treatment with peginterferon and ribavirin for chronic hepatitis C virus ( HCV ) genotype 2 or 3 infection produces a sustained virologic response ( SVR ) in 70 % -80 % of patients .
OBJECTIVE	We performed a randomized , double-blind , phase 2b study to assess whether adding daclatasvir , a nonstructural protein 5A ( NS5A ) inhibitor that is active against these genotypes , improves efficacy and shortens therapy .
METHODS	Patients with HCV genotype 2 or 3 infection ( n = 151 ) , enrolled at research centers in North America , Europe , or Australia , were assigned randomly to groups given 12 or 16 weeks of daclatasvir ( 60 mg once daily ) , or 24 weeks of placebo , each combined with peginterferon alfa-2a and ribavirin .
METHODS	Treatment was extended to 24 weeks for recipients of daclatasvir who did not meet the criteria for early virologic response .
METHODS	The primary end point was SVR at 24 weeks after treatment ( SVR24 ) .
RESULTS	Baseline characteristics were similar among patients within each HCV genotype group .
RESULTS	However , the 80 patients with HCV genotype 3 , compared with the 71 patients with HCV genotype 2 , were younger ( mean age , 45 vs 53 y , respectively ) , and a larger proportion had cirrhosis ( 23 % vs 1 % , respectively ) .
RESULTS	Among patients with HCV genotype 2 infection , an SVR24 was achieved by 83 % , 83 % , and 63 % of those in the daclatasvir 12-week group , the daclatasvir 16-week group , or the placebo group , respectively ; among patients with HCV genotype 3 infection , an SVR24 was achieved by 69 % , 67 % , and 59 % of patients in these groups , respectively .
RESULTS	Differences between genotypes largely were attributable to the higher frequency of post-treatment relapse among patients infected with HCV genotype 3 .
RESULTS	In both daclatasvir arms for both HCV genotypes , the lower bound of the 80 % confidence interval of the difference in SVR24 rates between the daclatasvir and placebo arms was above -20 % , establishing noninferiority .
RESULTS	Safety findings were similar among groups , and were typical of those expected from peginterferon alfa and ribavirin therapy .
CONCLUSIONS	Twelve or 16 weeks of treatment with daclatasvir , in combination with peginterferon alfa-2a and ribavirin , is a well tolerated and effective therapy for patients with HCV genotype 2 or 3 infections .
CONCLUSIONS	Daclatasvir-containing regimens could reduce the duration of therapy for these patients .
CONCLUSIONS	Clinicaltrials.gov number : NCT01257204 .

###24881631
BACKGROUND	In patients with chronic lymphoid leukemia ( CLL ) or small lymphocytic lymphoma ( SLL ) , a short duration of response to therapy or adverse cytogenetic abnormalities are associated with a poor outcome .
BACKGROUND	We evaluated the efficacy of ibrutinib , a covalent inhibitor of Bruton 's tyrosine kinase , in patients at risk for a poor outcome .
METHODS	In this multicenter , open-label , phase 3 study , we randomly assigned 391 patients with relapsed or refractory CLL or SLL to receive daily ibrutinib or the anti-CD20 antibody ofatumumab .
METHODS	The primary end point was the duration of progression-free survival , with the duration of overall survival and the overall response rate as secondary end points .
RESULTS	At a median follow-up of 9.4 months , ibrutinib significantly improved progression-free survival ; the median duration was not reached in the ibrutinib group ( with a rate of progression-free survival of 88 % at 6 months ) , as compared with a median of 8.1 months in the ofatumumab group ( hazard ratio for progression or death in the ibrutinib group , 0.22 ; P < 0.001 ) .
RESULTS	Ibrutinib also significantly improved overall survival ( hazard ratio for death , 0.43 ; P = 0.005 ) .
RESULTS	At 12 months , the overall survival rate was 90 % in the ibrutinib group and 81 % in the ofatumumab group .
RESULTS	The overall response rate was significantly higher in the ibrutinib group than in the ofatumumab group ( 42.6 % vs. 4.1 % , P < 0.001 ) .
RESULTS	An additional 20 % of ibrutinib-treated patients had a partial response with lymphocytosis .
RESULTS	Similar effects were observed regardless of whether patients had a chromosome 17p13 .1 deletion or resistance to purine analogues .
RESULTS	The most frequent nonhematologic adverse events were diarrhea , fatigue , pyrexia , and nausea in the ibrutinib group and fatigue , infusion-related reactions , and cough in the ofatumumab group .
CONCLUSIONS	Ibrutinib , as compared with ofatumumab , significantly improved progression-free survival , overall survival , and response rate among patients with previously treated CLL or SLL .
CONCLUSIONS	( Funded by Pharmacyclics and Janssen ; RESONATE ClinicalTrials.gov number , NCT01578707 . )

###25733462
BACKGROUND	Prior evidence suggests that high-calcium intake influences postprandial appetite and insulinemia , possibly due to elevated incretins .
BACKGROUND	In vitro and ex vivo models demonstrate that extracellular calcium and protein synergistically enhance secretion of incretins .
BACKGROUND	This is yet to be shown in humans .
OBJECTIVE	This study was designed to assess energy intake compensation in response to protein and calcium ingestion .
METHODS	Twenty healthy adults ( 13 men ; 7 women ) completed 4 trials in a randomized , double-blind crossover design separated by 48 h.
METHODS	During the trials , each participant consumed a low-calcium and low-protein control preload [ ( CON ) ; 4 g and 104 mg , respectively ] , a high-protein preload ( PRO ; 29 g ) , a high-calcium preload ( CAL ; 1170 mg ) , or a high-protein and high-calcium preload ( PROCAL ) .
METHODS	Blood samples were collected at baseline and 15 , 30 , 45 , and 60 min after preload ingestion to determine insulin and incretin hormone concentrations .
METHODS	Energy intake was assessed by a homogenous test meal 60 min after the preload .
METHODS	Visual analog scales were completed immediately before blood sampling to assess subjective appetite sensations .
RESULTS	Relative to the CON , the PRO produced 100 % ( 95 % CI : 85 % , 115 % ) energy compensation , whereas the CAL produced significant overcompensation [ 118 % ( 95 % CI : 104 % , 133 % ) ] , which was significantly more positive than with the PRO ( P < 0.05 ) .
RESULTS	The PROCAL resulted in energy compensation of 109 % ( 95 % CI : 95 % , 123 % ) , which tended to be greater than with the PRO ( P = 0.06 ) .
RESULTS	The mean difference in appetite sensations relative to the CON was not significantly different between the PRO ( -3 mm ; 95 % CI : -8 , 3 mm ) , CAL ( -5 mm ; 95 % CI : -9 , 0 mm ) , and PROCAL ( -5 mm ; 95 % CI : -10 , -1 mm ) ( P > 0.05 ) .
CONCLUSIONS	The addition of protein to a preload results in almost perfect energy compensation , whereas the addition of calcium , with or without protein , suppresses appetite and produces overcompensation of subsequent energy intake .
CONCLUSIONS	The role of circulating insulin and incretin concentrations in these responses , however , remains unclear .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01986036 .

###25119374
BACKGROUND	Chronic back pain ( CBP ) represents a significant public health problem .
BACKGROUND	As one of the most common causes of disability and sick leave , there is a need to develop cost-effective ways , such as Internet-based interventions , to help empower patients to manage their disease .
BACKGROUND	Research has provided evidence for the effectiveness of Internet-based interventions in many fields , but it has paid little attention to the reasons why they are effective .
OBJECTIVE	This study aims to assess the impact of interactive sections of an Internet-based self-management intervention on patient empowerment , their management of the disease , and , ultimately , health outcomes .
METHODS	A total of 51 patients were recruited through their health care providers and randomly assigned to either an experimental group with full access to the Internet-based intervention or a control group that was denied access to the interactive sections and knew nothing thereof .
METHODS	The intervention took 8 weeks .
METHODS	A baseline , a mid-term after 4 weeks , and a final assessment after 8 weeks measured patient empowerment , physical exercise , medication misuse , and pain burden .
RESULTS	All patients completed the study .
RESULTS	Overall , the intervention had a moderate effect ( F1 .52 = 2.83 , P = .03 , ( 2 ) = 0.30 , d = 0.55 ) .
RESULTS	Compared to the control group , the availability of interactive sections significantly increased patient empowerment ( midterm assessment : mean difference = +1.2 , P = .03 , d = 0.63 ; final assessment : mean difference = +0.8 , P = .09 , d = 0.44 ) and reduced medication misuse ( midterm assessment : mean difference = -1.5 , P = .04 , d = 0.28 ; final assessment : mean difference = -1.6 , P = .03 , d = -0.55 ) in the intervention group .
RESULTS	Both the frequency of physical exercise and pain burden decreased , but to equal measures in both groups .
CONCLUSIONS	Results suggest that interactive sections as part of Internet-based interventions can positively alter patients ' feelings of empowerment and help prevent medication misuse .
CONCLUSIONS	Detrimental effects were not observed .
BACKGROUND	ClinicalTrials.gov : NCT02114788 ; http://www.clinicaltrials.gov/ct2/show/NCT02114788 ( Archived by WebCite at http://www.webcitation.org/6ROXYVoPR ) .

###24898987
BACKGROUND	The role of low-intensity pulsed ultrasound ( LIPUS ) in the management of fractures remains controversial .
BACKGROUND	The purpose of this study was to assess the feasibility of a definitive trial to determine the effect of LIPUS on functional and clinical outcomes in tibial fractures managed operatively .
METHODS	We conducted a multicenter , concealed , blinded randomized trial of 51 skeletally mature adults with operatively managed tibial fractures who were treated with either LIPUS or a sham device .
METHODS	All participating centers were located in Canada and site investigators were orthopedic surgeons specializing in trauma surgery .
METHODS	The goals of our pilot study were to determine recruitment rates in individual centers , investigators ' ability to adhere to study protocol and data collection procedures , our ability to achieve close to 100 % follow-up rates , and the degree to which patients were compliant with treatment .
METHODS	Patients were followed for one year and a committee ( blinded to allocation ) adjudicated all outcomes .
METHODS	The committee adjudicators were experienced ( 10 or more years in practice ) orthopedic surgeons with formal research training , specializing in trauma surgery .
RESULTS	Our overall rate of recruitment was approximately 0.8 patients per center per month and site investigators successfully adhered to the study protocol and procedures .
RESULTS	Our rate of follow-up at one year was 84 % .
RESULTS	Patient compliance , measured by an internal timer in the study devices , revealed that 39 ( 76 % ) of the patients were fully compliant and 12 ( 24 % ) demonstrated a greater than 50 % compliance .
RESULTS	Based on patient feedback regarding excessive questionnaire burden , we conducted an analysis using data from another tibial fracture trial that revealed the Short Musculoskeletal Function Assessment ( SMFA ) dysfunction index offered no important advantages over the SF-36 Physical Component Summary ( PCS ) score .
RESULTS	No device-related adverse events were reported .
CONCLUSIONS	Our pilot study identified key issues that might have rendered a definitive trial unfeasible .
CONCLUSIONS	By modifying our protocol to address these challenges we have enhanced the feasibility of a definitive trial to explore the effect of LIPUS on tibial fracture healing .
BACKGROUND	The TRUST definitive trial was registered at ClinicalTrials.gov on 21 April 2008 ( identifier : NCT00667849 ) .

###25043278
BACKGROUND	An inactivated poliovirus vaccine ( IPV ) based on attenuated poliovirus strains ( Sabin-1 , -2 and -3 ) was developed for technology transfer to manufacturers in low - and middle-income countries in the context of the global polio eradication initiative .
METHODS	Safety and immunogenicity of Sabin-IPV ( sIPV ) was evaluated in a double-blind , randomized , controlled , dose-escalation trial in the target population .
METHODS	Healthy infants ( n = 20/group ) aged 56-63 days , received a primary series of three intramuscular injections with low - , middle - or high-dose sIPV with or without aluminum hydroxide or with the conventional IPV based on wild poliovirus strains ( wIPV ) .
METHODS	Virus-neutralizing titers against both Sabin and wild poliovirus strains were determined before and 28 days after three vaccinations .
RESULTS	The incidence of local and systemic reactions was comparable with the wIPV .
RESULTS	Seroconversion rates after three vaccinations were 100 % for type 2 and type 3 polioviruses ( both Sabin and wild strains ) and 95-100 % for type 1 polioviruses .
RESULTS	Median titers were high in all groups .
RESULTS	Titers were well above the log2 ( titer ) correlated with protection ( = 3 ) for all groups .
RESULTS	Median titers for Sabin-2 were 9.3 ( range 6.8-11 .5 ) in the low-dose sIPV group , 9.2 ( range 6.8-10 .2 ) in the low-dose adjuvanted sIPV group and 9.8 ( range 5.5-15 .0 ) in the wIPV group , Median titers against MEF-1 ( wild poliovirus type 2 ) were 8.2 ( range 4.8-10 .8 ) in the low-dose sIPV group , 7.3 ( range 4.5-10 .2 ) in the low-dose adjuvanted Sabin-IPV group and 10.3 ( range 8.5-17 .0 ) in the wIPV group .
RESULTS	For all poliovirus types the median titers increased with increasing dose levels .
CONCLUSIONS	sIPV and sIPV adjuvanted with aluminum hydroxide were immunogenic and safe at all dose levels , and comparable with the wIPV .
CONCLUSIONS	EudraCTnr : 2011-003792-11 , NCT01709071 .

###25012804
BACKGROUND	Laparoscopic magnetic sphincter augmentation ( MSA ) with the LINX device is a promising new therapy for the treatment of gastroesophageal reflux disease ( GERD ) .
BACKGROUND	Initial studies have demonstrated MSA to be safe and effective .
BACKGROUND	However , no direct comparison between MSA and laparoscopic Nissen fundoplication ( LNF ) , the gold standard surgical therapy for GERD , has been performed .
METHODS	A single institution , case-control study was conducted of MSA performed from 2012 to 2013 and a cohort of LNF matched for age , gender , and hiatal hernia size .
RESULTS	MSA and LNF were both effective treatments for reflux with 75 and 83 % of patients , respectively , reporting resolution of GERD at short-term follow-up .
RESULTS	Dysphagia was common following both MSA and LNF , but severe dysphagia requiring endoscopic dilation was more frequent after MSA ( 50 vs. 0 % , p = 0.01 ) .
RESULTS	Need for dilation did not correlate with size of the LINX device or any other examined patient factors .
RESULTS	A trend toward decreased adverse GI symptoms of bloating , flatulence , and diarrhea was seen after MSA compared to LNF ( 0 vs. 33 % ) .
RESULTS	MSA had a shorter operative time ( 64 vs. 90 min , p < 0.01 ) but other peri-operative outcomes , including pain , morbidity , and re-admissions were equivalent to LNF .
RESULTS	MSA patients were more likely to be self-referred ( 58 vs. 0 % , p < 0.001 ) .
CONCLUSIONS	MSA and LNF are both effective and safe treatments for GERD ; however , severe dysphagia requiring endoscopic intervention is more common with MSA .
CONCLUSIONS	Other adverse GI side effects may be less frequent after MSA .
CONCLUSIONS	Consideration should be paid to these distinct post-operative symptom profiles when selecting a surgical therapy for reflux disease .

###24794277
OBJECTIVE	The aim of this trial was to compare the rates of patency achieved by cutting and conventional balloon angioplasty to treat hemodialysis access stenoses .
METHODS	End-stage renal failure patients ( at three tertiary referral centers ) with significant hemodialysis access stenoses were prospectively randomized to have percutaneous transluminal angioplasty ( PTA ) by either cutting or conventional balloons .
METHODS	Patients with more than one hemodynamically significant stenosis were excluded .
METHODS	Kaplan-Meier method was used to compare the primary assisted patency rates for the two groups .
RESULTS	The study randomized 623 patients into two groups , and the duration of follow-up was 15 3 months .
RESULTS	In the cutting balloon angioplasty group , the clinical success rate was 89 % ( 282 of 316 stenoses ) .
RESULTS	In the conventional balloon angioplasty group , the clinical success rate was 86 % ( 265 of 307 stenoses ; P = .637 ) .
RESULTS	Assisted primary patency for cutting PTA was statistically significantly higher at 6 months and 1 year ( 86 % and 63 % ) than that for conventional PTA ( 56 % and 37 % , respectively ; P = .037 ) in the treatment of stenosis of the graft-to-vein anastomosis .
RESULTS	In the venous stenosis subgroup , equivalent primary assisted patency at 6 months and 1 year was observed for cutting PTA ( 84 % and 55 % ) and conventional PTA ( 70 % and 46 % , respectively ; P = .360 ) .
RESULTS	In the intragraft stenosis subgroup , primary assisted patency was equivalent at 6 months and 1 year for cutting PTA ( 67 % and 39 % ) and conventional PTA ( 62 % and 49 % , respectively ; P = .371 ) .
RESULTS	In the arterial anastomotic stenosis subgroup , assisted primary patency at 6 months and 1 year was equivalent for cutting PTA ( 70 % and 30 % ) and conventional PTA ( 75 % and 33 % , respectively ; P = .921 ) .
CONCLUSIONS	Cutting balloon angioplasty proved to be a safe and effective treatment of graft-to-vein anastomotic stenosis , with significantly higher patency than that of conventional balloon angioplasty .

###24439974
BACKGROUND	There is strong evidence of an association between chronic kidney disease ( CKD ) and cardiovascular disease .
BACKGROUND	To date , however , proof that a reduction in glomerular filtration rate ( GFR ) is a causative factor in cardiovascular disease is lacking .
BACKGROUND	Kidney donors comprise a highly screened population without risk factors such as diabetes and inflammation , which invariably confound the association between CKD and cardiovascular disease .
BACKGROUND	There is strong evidence that increased arterial stiffness and left ventricular hypertrophy and fibrosis , rather than atherosclerotic disease , mediate the adverse cardiovascular effects of CKD .
BACKGROUND	The expanding practice of live kidney donation provides a unique opportunity to study the cardiovascular effects of an isolated reduction in GFR in a prospective fashion .
BACKGROUND	At the same time , the proposed study will address ongoing safety concerns that persist because most longitudinal outcome studies have been undertaken at single centers and compared donor cohorts with an inappropriately selected control group .
OBJECTIVE	The reduction in GFR accompanying uninephrectomy causes ( 1 ) a pressure-independent increase in aortic stiffness ( aortic pulse wave velocity ) and ( 2 ) an increase in peripheral and central blood pressure .
METHODS	This is a prospective , multicenter , longitudinal , parallel group study of 440 living kidney donors and 440 healthy controls .
METHODS	All controls will be eligible for living kidney donation using current UK transplant criteria .
METHODS	Investigations will be performed at baseline and repeated at 12 months in the first instance .
METHODS	These include measurement of arterial stiffness using applanation tonometry to determine pulse wave velocity and pulse wave analysis , office blood pressure , 24-hour ambulatory blood pressure monitoring , and a series of biomarkers for cardiovascular and bone mineral disease .
CONCLUSIONS	These data will prove valuable by characterizing the direction of causality between cardiovascular and renal disease .
CONCLUSIONS	This should help inform whether targeting reduced GFR alongside more traditional cardiovascular risk factors is warranted .
CONCLUSIONS	In addition , this study will contribute important safety data on living kidney donors by providing a longitudinal assessment of well-validated surrogate markers of cardiovascular disease , namely , blood pressure and arterial stiffness .
CONCLUSIONS	If any adverse effects are detected , these may be potentially reversed with the early introduction of targeted therapy .
CONCLUSIONS	This should ensure that kidney donors do not come to long-term harm and thereby preserve the ongoing expansion of the living donor transplant program ( NCT01769924 ) .

###25241229
BACKGROUND	Chemoradiotherapy ( CHRT ) is often advocated for locally-advanced biliary tract cancer ( LABTC ) .
BACKGROUND	However there was not comparative study with chemotherapy alone ( CH ) .
METHODS	Patients with hilar or extrahepatic non-metastatic , LABTC could be included in this phase II trial .
METHODS	The inclusion criteria required World Health Organisation ( WHO ) performance status 2 , bilirubinemia 50 M/L after biliary drainage if necessary , and possibility of external radiotherapy .
METHODS	Fluorouracil ( 5 FU ) infusion and cisplatin , were given in association to radiotherapy ( 50 Gy ) in the CHRT arm .
METHODS	Gemcitabine + oxaliplatin ( GEMOX ) was planned for 6 months in the CH arm .
METHODS	End-points were progression-free survival ( PFS ) , overall survival ( OS ) , toxicity and rate of biliary complications .
RESULTS	The trial was closed before completion due to slow recruitment .
RESULTS	Eighteen and 16 patients were included in the CHRT and CH arms , respectively .
RESULTS	Median follow up was 27.9 months ( 2.8 ) .
RESULTS	Grade III-IV toxicities were mostly haematological ( 23 % and 25 % ) , and gastrointestinal ( 11 % and 6 % ) , in the CHRT and CH arm , respectively .
RESULTS	Biliary complications occurred in 28 % of patients in the CHRT arm and 44 % of patients in the CH arm ( risk ratio ( RR ) : 1.60 [ 0.65-3 .92 ] ) .
RESULTS	Median PFS was 5.8 months in the CHRT group and 11.0 months in the CH group ( hazard ratio ( HR ) : 0.65 [ 0.32-1 .33 ] ) .
RESULTS	Median OS was 13.5 months in the CHRT group and 19.9 months in the CH group ( HR : 0.69 [ 0.31-1 .55 ] ) .
CONCLUSIONS	Combination of gemcitabine plus cisplatin seems to be at least as efficient as chemoradiotherapy ( 50 Gy plus 5 FU and cisplatin ) in LABTC .

###24999148
BACKGROUND	Premature infants not only feel and understand the pain , but also respond more intensively compared with term infants .
BACKGROUND	Non-pharmacological methods of pain control are suitable to relieve pain in painful procedures .
BACKGROUND	The facilitated tucking position is considered as a non-pharmacological method of pain control in infants ; however , its impact on frequent and repeated procedural pain such as endotracheal suctioning remains to be studied .
OBJECTIVE	This paper is the report of a study that examined the impact of facilitated tucking position on behavioral pain during suctioning in premature neonates .
METHODS	This was a clinical trial study with a crossover design .
METHODS	The study was conducted in a level II Neonatal Intensive Care Unit , located in a teaching hospital , affiliated to Tehran University of Medical Sciences , Tehran , Iran .
METHODS	Thirty four infants were enrolled in this study based on the following inclusion criteria : age between 29 to 37 weeks of gestational age , birth weight 1200 grams or more , having an endotracheal tube , no congenital anomalies , no seizures diagnosis , no chest tubes , no intracranial hemorrhage higher than degree II , not receiving opiates and sedatives four hours before intervention and not receiving any painful procedure at least half an hour before the intervention .
METHODS	The samples were randomly received a sequence of suctioning with/without or suctioning without/with facilitated tucking .
METHODS	Preterm Infant Pain Profile ( PIPP ) was used to collect the data .
METHODS	SPSS version 16.0 for Windows ( SPSS Inc. , Chicago , IL , USA ) was used for statistical analysis .
RESULTS	While 38.2 % of infants experienced severe pain during suctioning without intervention , only 8.8 % of them experienced severe pain during suctioning with intervention .
RESULTS	The results of the paired t-test show that there is a statistically significant difference in the mean scores of pain between non-intervention and intervention cases ( p < 0.001 ) , and the mean pain score substantially reduced in cases with intervention .
CONCLUSIONS	Given the multiplicity of endotracheal suctioning frequency and the impossibility of frequent use of pharmacological methods of pain relief , the facilitated tucking position can be used as a safe non-pharmacological method for procedural pain management .

###24274317
BACKGROUND	Moisturisers prevent and treat dry skin .
BACKGROUND	They can also protect sensitive skin , improve skin tone and texture , and mask imperfections .
BACKGROUND	Herbal medicines or their extracts have been available as topical formulations and cosmetics .
BACKGROUND	Arctium lappa L. ( Asteraceae ) has been used to treat inflammatory disorders and various skin problems .
BACKGROUND	It could be a candidate herbal medicine for treating dry skin condition.This study aims to establish the efficacy and safety of a proposed herbal moisturising cream containing Arctium lappa L. seed extract , which has been approved by the Korean Ministry of Food and Drug Safety for use in cosmetics .
METHODS	This study is a randomised , double-blind , placebo-controlled study with two parallel groups ( proposed herbal moisturising cream vs. placebo cream ) .
METHODS	We will recruit 66 healthy male and female participants , aged 20 to 65 years , who have been diagnosed with dry skin conditions .
METHODS	Participants will be randomly allocated to receive either the proposed herbal moisturising cream or a placebo cream for four weeks .
METHODS	Each participant will be examined for signs and symptoms before and after using the cream .
METHODS	Skin hydration , sebum ( oily secretion ) levels and transepidermal water loss ( TEWL ; constitutive loss of water from the skin surface ) will be assessed .
METHODS	Participants will also be asked to fill out a health-related quality of life questionnaire .
METHODS	Safety will be assessed using blood tests , urine analysis , a pregnancy test , and the assessment of vital signs .
CONCLUSIONS	This trial will utilise high-quality methodologies in accordance with both consolidated standards for reporting trials guidelines and the guidelines for clinical trials of cosmetics products that are aimed at expressions and advertisement approval in Korea .
CONCLUSIONS	It will evaluate the clinical efficacy and safety of a proposed herbal moisturising cream containing Arctium lappa L. seed extract to treat dry skin conditions and provide itch relief .
CONCLUSIONS	Moreover , we will also employ health-related quality of life questionnaires to assess changes in the quality of life .
CONCLUSIONS	The results of this study will be used to present the evidence needed to request advertising/display allowances , in compliance with the recently amended Cosmetics Act for advertisement in Korea .
BACKGROUND	Current Controlled Trials ISRCTN46216631 .

###24229349
BACKGROUND	A few observational studies have found an inverse association between adherence to a Mediterranean diet and the risk of depression .
BACKGROUND	Randomized trials with an intervention based on this dietary pattern could provide the most definitive answer to the findings reported by observational studies .
BACKGROUND	The aim of this study was to compare in a randomized trial the effects of two Mediterranean diets versus a low-fat diet on depression risk after at least 3 years of intervention .
METHODS	This was a multicenter , randomized , primary prevention field trial of cardiovascular disease ( Prevencin con Dieta Mediterrnea ( PREDIMED Study ) ) based on community-dwelling men aged 55 to 80 years and women aged 60 to 80 years at high risk of cardiovascular disease ( 51 % of them had type 2 diabetes ; DM2 ) attending primary care centers affiliated with 11 Spanish teaching hospitals .
METHODS	Primary analyses were performed on an intention-to-treat basis .
METHODS	Cox regression models were used to assess the relationship between the nutritional intervention groups and the incidence of depression .
RESULTS	We identified 224 new cases of depression during follow-up .
RESULTS	There was an inverse association with depression for participants assigned to a Mediterranean diet supplemented with nuts ( multivariate hazard ratio ( HR ) 0.78 ; 95 % confidence interval ( CI ) 0.55 to 1.10 ) compared with participants assigned to the control group , although this was not significant .
RESULTS	However , when the analysis was restricted to participants with DM2 , the magnitude of the effect of the intervention with the Mediterranean diet supplemented with nuts did reach statistical significance ( multivariate HR = 0.59 ; 95 % CI 0.36 to 0.98 ) .
CONCLUSIONS	The result suggest that a Mediterranean diet supplemented with nuts could exert a beneficial effect on the risk of depression in patients with DM2 .
BACKGROUND	This trial has been registered in the Current Controlled Trials with the number ISRCTN 35739639 .

###24237777
OBJECTIVE	To compare octyl-2-cyanoacrylate ( 2-OCA ) tissue adhesive with subcuticular suture for the closure of incisions in the maxillofacial region to determine 1 ) whether it is faster than traditional subcuticular suturing , 2 ) whether the number and length of incisions affect closure time , 3 ) wound morbidity , 4 ) patient satisfaction outcome , and 5 ) cosmetic outcome .
METHODS	In a prospective randomized clinical trial , 29 patients were allocated to 1 of 2 groups for the closure of skin incisions using 2-OCA or conventional subcuticular skin sutures .
METHODS	Postoperative follow-up evaluated wound healing at 5 to 10 days and at 3 months .
METHODS	Assessment of cosmetic outcome was performed by a plastic surgeon using a modified Hollander Wound Evaluation Scale and a validated visual analog scale .
METHODS	Comparisons between groups were performed using the Student t test and ( 2 ) test .
RESULTS	Twenty incisions in 14 patients were closed with 2-OCA and 20 incisions in 15 patients were closed with subcuticular sutures .
RESULTS	Mean time of closure was significantly ( P < .005 ) faster with 2-OCA at 69.50 33.39 seconds compared with 379.00 75.39 seconds in the suture group .
RESULTS	There was no significant difference in wound complications between the 2 groups ; also , there was no significant difference in patient satisfaction and cosmetic outcome of scars at the 3-month follow-up between the 2 groups .
CONCLUSIONS	2-OCA tissue adhesive is an excellent alternative to sutures for effective , reliable , and faster skin closure of maxillofacial incisions .

###24244435
BACKGROUND	Keeping girls in school offers them protection against early marriage , teen pregnancy , and sexual harms , and enhances social and economic equity .
BACKGROUND	Studies report menstruation exacerbates school-drop out and poor attendance , although evidence is sparse .
BACKGROUND	This study qualitatively examines the menstrual experiences of young adolescent schoolgirls .
RESULTS	The study was conducted in Siaya County in rural western Kenya .
RESULTS	A sample of 120 girls aged 14-16 years took part in 11 focus group discussions , which were analysed thematically .
RESULTS	The data gathered were supplemented by information from six FGDs with parents and community members .
RESULTS	Emergent themes were : lack of preparation for menarche ; maturation and sexual vulnerability ; menstruation as an illness ; secrecy , fear and shame of leaking ; coping with inadequate alternatives ; paying for pads with sex ; and problems with menstrual hygiene .
RESULTS	Girls were unprepared and demonstrated poor reproductive knowledge , but devised practical methods to cope with menstrual difficulties , often alone .
RESULTS	Parental and school support of menstrual needs is limited , and information sparse or inaccurate .
RESULTS	Girls ' physical changes prompt boys and adults to target and brand girls as ripe for sexual activity including coercion and marriage .
RESULTS	Girls admitted ` others ' rather than themselves were absent from school during menstruation , due to physical symptoms or inadequate sanitary protection .
RESULTS	They described difficulties engaging in class , due to fear of smelling and leakage , and subsequent teasing .
RESULTS	Sanitary pads were valued but resource and time constraints result in prolonged use causing chafing .
RESULTS	Improvised alternatives , including rags and grass , were prone to leak , caused soreness , and were perceived as harmful .
RESULTS	Girls reported ` other girls ' but not themselves participated in transactional sex to buy pads , and received pads from boyfriends .
CONCLUSIONS	In the absence of parental and school support , girls cope , sometimes alone , with menarche in practical and sometimes hazardous ways .
CONCLUSIONS	Emotional and physical support mechanisms need to be included within a package of measures to enable adolescent girls to reach their potential .

###25465497
BACKGROUND	First degree relatives ( FDRs ) of men diagnosed with prostate cancer ( PCa ) are at increased risk for developing the disease , due in part to multiple concurrent risk factors .
BACKGROUND	There is a lack of innovative targeted decision aids to help FDRs make an informed decision about whether or not to undergo PCa screening .
OBJECTIVE	This randomized pilot trial evaluated the efficacy of a targeted PCa screening decision aid in unaffected FDRs of PCa survivors .
METHODS	Seventy-eight Black and White FDRs were randomized to one of two decision aid groups ; 39 to a FDR-targeted decision aid and 39 to a general decision aid .
METHODS	The targeted decision aid group received a general PCa decision aid booklet plus a newly developed decision aid DVD targeted specifically for FDRs .
METHODS	PCa screening decision outcomes included knowledge , decisional conflict , distress , and satisfaction with screening decision .
METHODS	Outcomes were assessed at baseline and 4 weeks after baseline .
RESULTS	There were no differences by intervention group for knowledge , decisional conflict , distress , or satisfaction with screening decision ( p > 0.05 ) .
RESULTS	However , men in both groups had significant increases in knowledge and decreases in decisional conflict ( p < 0.001 ) .
RESULTS	These changes were most pronounced ( p < 0.05 ) for younger men compared to older men .
CONCLUSIONS	Results suggest that general and targeted information can play an important role in increasing knowledge and decreasing decisional conflict among FDRs .
CONCLUSIONS	Additional research is needed to identify subgroups of men who benefit the most and better understand the outcomes of a screening decision aid among diverse samples of FDRs .

###25165161
BACKGROUND	Live attenuated influenza vaccine ( LAIV ) and inactivated influenza vaccine ( IIV ) are available for children .
BACKGROUND	Local and systemic immunity induced by LAIV followed a month later by LAIV and IIV followed by LAIV were investigated with virus recovery after LAIV doses as surrogates for protection against influenza on natural exposure .
METHODS	Fifteen children received IIV followed by LAIV , 13 an initial dose of LAIV , and 11 a second dose of LAIV .
METHODS	The studies were done during autumn 2009 and autumn 2010 with the same seasonal vaccine ( A/California/07 / 09 [ H1N1 ] , A/Perth/16 / 09 [ H3N2 ] , B/Brisbane/60 / 08 ) .
RESULTS	Twenty-eight of 39 possible influenza viral strains were recovered after the initial dose of LAIV .
RESULTS	When LAIV followed IIV , 21 of 45 viral strains were identified .
RESULTS	When compared to primary LAIV infection , the decreased frequency of shedding with the IIV-LAIV schedule was significant ( P = .023 ) .
RESULTS	With LAIV-LAIV , the fewest viral strains were recovered ( 3/33 ) -- numbers significantly lower ( P < .001 ) than shedding after initial LAIV and after IIV-LAIV ( P < .001 ) .
RESULTS	Serum hemagglutination inhibition antibody responses were more frequent after IIV than LAIV ( P = .02 ) .
RESULTS	In contrast , more mucosal immunoglobulin A responses were seen with LAIV .
CONCLUSIONS	LAIV priming induces greater inhibition of virus recovery on LAIV challenge than IIV priming .
CONCLUSIONS	The correlate ( s ) of protection are the subject of ongoing analysis .
BACKGROUND	NCT01246999 .

###25433517
BACKGROUND	Rheumatoid arthritis ( RA ) is a chronic autoimmune condition that results in pain and disability .
BACKGROUND	Patients with RA have a decreased functional ability and are forced into a sedentary lifestyle and as such , these patients often become predisposed to poor bone health .
BACKGROUND	Patients with RA may also experience a decreased health related quality of life ( HRQoL ) due to their disease .
BACKGROUND	Whole body vibration ( WBV ) is a form of exercise that stimulates bone loading through forced oscillation .
BACKGROUND	WBV has also been shown to decrease pain and fatigue in other rheumatic diseases , as well as to increase muscle strength .
BACKGROUND	This paper reports on the development of a semi randomised controlled clinical trial to assess the impact of a WBV intervention aiming to improve functional ability , attenuate bone loss , and improve habitual physical activity levels in patients with RA .
METHODS	This study is a semi randomised , controlled trial consisting of a cohort of patients with established RA assigned to either a WBV group or a CON ( control ) group .
METHODS	Patients in the WBV group will undergo three months of twice weekly intermittent WBV sessions , while the CON group will receive standard care and continue with normal daily activities .
METHODS	All patients will be assessed at baseline , following the three month intervention , and six months post intervention .
METHODS	Main outcomes will be an improvement in functional ability as assessed by the HAQ .
METHODS	Secondary outcomes are attenuation of loss of bone mineral density ( BMD ) at the hip and changes in RA disease activity , HRQoL , habitual physical activity levels and body composition .
CONCLUSIONS	This study will provide important information regarding the effects of WBV on functional ability and BMD in patients with RA , as well as novel data regarding the potential changes in objective habitual physical activity patterns that may occur following the intervention .
CONCLUSIONS	The sustainability of the intervention will also be assessed .
BACKGROUND	PACTR201405000823418 ( 19/05/2014 ) .

###24708232
OBJECTIVE	To evaluate the impact upon medication adherence of brief telephone-based counseling using principles of motivational interviewing and telehealth home monitoring .
METHODS	Randomized controlled pilot trial of 19 veterans with multiple sclerosis ( MS ) currently prescribed disease modifying therapy ( DMT ) who endorsed missing doses .
METHODS	Follow-up was conducted at 1 , 3 , and 6 months .
RESULTS	Participants in the intervention condition reported better adherence relative to controls at 6-month follow-up [ M ( SD ) = 1.3 ( 2.1 ) vs. 8.2 ( 12.3 ) past month missed doses ] .
RESULTS	All participants in the intervention condition completed all 3 telephone counseling sessions and 90 % or greater rated the program as highly successful .
CONCLUSIONS	Brief telephone counseling represents a promising mechanism for improving medication adherence .
CONCLUSIONS	The primary components , motivational interviewing and home telehealth monitoring , provided complementary mechanisms for initiating and sustaining behavior change over time .
CONCLUSIONS	The intervention was well tolerated and provided an opportunity to extend access and reduce barriers to care by bringing it into the homes of participants .

###25083727
OBJECTIVE	Repeated-sprint training in hypoxia ( RSH ) was recently shown to improve repeated-sprint ability ( RSA ) in cycling .
OBJECTIVE	This phenomenon is likely to reflect fiber type-dependent , compensatory vasodilation , and therefore , our hypothesis was that RSH is even more beneficial for activities involving upper body muscles , such as double poling during cross-country skiing .
METHODS	In a double-blinded fashion , 17 competitive cross-country skiers performed six sessions of repeated sprints ( each consisting of four sets of five 10-s sprints , with 20-s intervals of recovery ) either in normoxia ( RSN , 300 m ; FiO2 , 20.9 % ; n = 8 ) or normobaric hypoxia ( RSH , 3000 m ; FiO2 , 13.8 % ; n = 9 ) .
METHODS	Before ( pre ) and after ( post ) training , performance was evaluated with an RSA test ( 10-s all-out sprints-20-s recovery , until peak power output declined by 30 % ) and a simulated team sprint ( team sprint , 3 3-min all-out with 3-min rest ) on a double-poling ergometer .
METHODS	Triceps brachii oxygenation was measured by near-infrared spectroscopy .
RESULTS	From pretraining to posttraining , peak power output in the RSA was increased ( P < 0.01 ) to the same extent ( 29 % 13 % vs 26 % 18 % , nonsignificant ) in RSH and in RSN whereas the number of sprints performed was enhanced in RSH ( 10.9 5.2 vs 17.1 6.8 , P < 0.01 ) but not in RSN ( 11.6 5.3 vs 11.7 4.3 , nonsignificant ) .
RESULTS	In addition , the amplitude in total hemoglobin variations during sprints throughout RSA rose more in RSH ( P < 0.01 ) .
RESULTS	Similarly , the average power output during all team sprints improved by 11 % 9 % in RSH and 15 % 7 % in RSN .
CONCLUSIONS	Our findings reveal greater improvement in the performance of repeated double-poling sprints , together with larger variations in the perfusion of upper body muscles in RSH compared with those in RSN .

###24557078
BACKGROUND	Atazanavir-associated hyperbilirubinemia can cause premature discontinuation of atazanavir and avoidance of its initial prescription .
BACKGROUND	We used genomewide genotyping and clinical data to characterize determinants of atazanavir pharmacokinetics and hyperbilirubinemia in AIDS Clinical Trials Group protocol A5202 .
METHODS	Plasma atazanavir pharmacokinetics and indirect bilirubin concentrations were characterized in HIV-1-infected patients randomized to atazanavir/ritonavir-containing regimens .
METHODS	A subset had genomewide genotype data available .
RESULTS	Genomewide assay data were available from 542 participants , of whom 475 also had data on estimated atazanavir clearance and relevant covariates available .
RESULTS	Peak bilirubin concentration and relevant covariates were available for 443 participants .
RESULTS	By multivariate analysis , higher peak on-treatment bilirubin levels were found to be associated with the UGT1A1 rs887829 T allele ( P = 6.410 ( -12 ) ) , higher baseline hemoglobin levels ( P = 4.910 ( -13 ) ) , higher baseline bilirubin levels ( P = 6.710 ( -12 ) ) , and slower plasma atazanavir clearance ( P = 8.610 ( -11 ) ) .
RESULTS	For peak bilirubin levels greater than 3.0 mg/dl , the positive predictive value of a baseline bilirubin level of 0.5 mg/dl or higher with hemoglobin concentrations of 14 g/dl or higher was 0.51 , which increased to 0.85 with rs887829 TT homozygosity .
RESULTS	For peak bilirubin levels of 3.0 mg/dl or lower , the positive predictive value of a baseline bilirubin level less than 0.5 mg/dl with a hemoglobin concentration less than 14 g/dl was 0.91 , which increased to 0.96 with rs887829 CC homozygosity .
RESULTS	No polymorphism predicted atazanavir pharmacokinetics at genomewide significance .
CONCLUSIONS	Atazanavir-associated hyperbilirubinemia is best predicted by considering UGT1A1 genotype , baseline bilirubin level , and baseline hemoglobin level in combination .
CONCLUSIONS	Use of ritonavir as a pharmacokinetic enhancer may have abrogated genetic associations with atazanavir pharmacokinetics .

###24997587
BACKGROUND	Permanent joint damage is a major consequence of rheumatoid arthritis ( RA ) , the most common and destructive form of inflammatory arthritis .
BACKGROUND	In aggressive disease , joint damage can occur within 6months from symptom onset .
BACKGROUND	Early , intensive treatment with conventional and biologic disease-modifying anti-rheumatic drugs ( DMARDs ) can delay the onset and progression of joint damage .
BACKGROUND	The primary objective of the study is to investigate the value of magnetic resonance imaging ( MRI ) or radiography ( X-ray ) over standard of care as tools to guide DMARD treatment decision-making by rheumatologists for the care of RA .
METHODS	A double-blind , randomized controlled trial has been designed .
METHODS	Rheumatoid and undifferentiated inflammatory arthritis patients will undergo an MRI and X-ray assessment every 6months .
METHODS	Baseline adaptive randomization will be used to allocate participants to MRI , X-ray , or sham-intervention groups on a background of standard of care .
METHODS	Prognostic markers , treating physician , and baseline DMARD therapy will be used as intervention allocation parameters .
METHODS	The outcome measures in rheumatology RA MRI score and the van der Heijde-modified Sharp score will be used to evaluate the MRI and X-ray images , respectively .
METHODS	Radiologists will score anonymized images for all patients regardless of intervention allocation .
METHODS	Disease progression will be determined based on the study-specific , inter-rater smallest detectable difference .
METHODS	Allocation-dependent , intervention-concealed reports of positive or negative disease progression will be reported to the treating rheumatologist .
METHODS	Negative reports will be delivered for the sham-intervention group .
METHODS	Study-based radiology clinical reports will be provided to the treating rheumatologists for extra-study X-ray requisitions to limit patient radiation exposure as part of diagnostic imaging standard of care .
METHODS	DMARD treatment dose escalation and therapy changes will be measured to evaluate the primary objective .
METHODS	A sample size of 186 ( 62 per group ) patients will be required to determine a 36 % difference in pharmacological treatment escalation between the three groups with intermediate dispersion of data with 90 % power at a 5 % level of significance .
CONCLUSIONS	This study will determine if monitoring RA and undifferentiated inflammatory arthritis patients using MRI and X-ray every 6months over 2years provides incremental evidence over standard of care to influence pharmacotherapeutic decision-making and ultimately hinder disease progression .
BACKGROUND	This trial has been registered at ClinicalTrials.gov : NCT00808496 ( registered on 12 December 2008 ) .

###24254262
OBJECTIVE	Proton-pump inhibitor and ranitidine bismuth citrate-based triple regimens are the two recommended first line treatments for the eradication of Helicobacter pylori .
OBJECTIVE	We aimed to compare the effectiveness and tolerability of these two treatments in a prospective , multicentric , randomized study .
METHODS	Patients with dyspeptic complaints were recruited from 15 study centers .
METHODS	Presence of Helicobacter pylori was investigated by both histology and rapid urease test .
METHODS	The patients were randomized to either ranitidine bismuth citrate 400 mg bid plus amoxicillin 1 g bid plus clarithromycin 500 mg bid ( n = 149 ) or lansoprazole 30 mg bid plus amoxicillin 1 g bid plus clarithromycin 500 mg bid ( n = 130 ) treatment arm for 14 days .
METHODS	Adverse events have been recorded during the treatment phase .
METHODS	A 13 C urea breath test was performed 6 weeks after termination of treatment to assess the efficacy of the therapy .
METHODS	Eradication rate was calculated by intention-to-treat and per-protocol analysis .
RESULTS	Two hundred seventy-nine patients ( 123 male , 156 female ) were eligible for randomization .
RESULTS	In per-protocol analysis ( n = 247 ) , Helicobacter pylori was eradicated with ranitidine bismuth citrate - and lansoprazole-based regimens in 74,6 % and 69,2 % of cases , respectively ( p > 0,05 ) .
RESULTS	Intention-to-treat analysis ( n = 279 ) revealed that eradication rates were 65,1 % and 63,6 % in ranitidine bismuth citrate and in lansoprazole-based regimens , respectively ( p > 0,05 ) .
RESULTS	Both regimes were well-tolerated , and no serious adverse event was observed during the study .
CONCLUSIONS	Ranitidine bismuth citrate-based regimen is at least as effective and tolerable as the classical proton-pump inhibitor-based regimen , but none of the therapies could achieve the recommendable eradication rate .

###24496072
BACKGROUND	Centrally acting angiotensin converting enzyme inhibitors ( CACE-Is ) are associated with reduced rates of cognitive decline in patients with dementia .
BACKGROUND	CACE-Is may also improve exercise tolerance in functionally impaired older adults with normal cognition , suggesting that CACE-Is may positively influence activities of daily living ( ADL ) in dementia .
OBJECTIVE	To compare rates of decline in patients with mild to moderate Alzheimer 's disease ( AD ) receiving CACE-Is to those not currently treated with CACE-Is ( NoCACE-I ) , included in the Doxycycline and Rifampicin for Alzheimer 's Disease study ( n = 406 ) .
METHODS	Patients were included if baseline and end-point ( twelve months apart ) scores were available for measures including the Standardized Alzheimer 's Disease Assessment Scale - Cognitive Subscale ; Quick Mild Cognitive Impairment screen ; Clinical Dementia Rating Scale ( CDR-SB ) , and Lawton-Brody ADL Scale .
RESULTS	There was a significant , 25 % difference ( median one-point ) in the 12-month rate of decline in ADL scores in patients taking CACE-Is ( n = 91 ) , compared to the NoCACE-I group ( n = 274 ) , p = 0.024 .
RESULTS	This remained significant after adjusting for age , gender , education , and blood pressure , p = 0.034 .
RESULTS	When individual CACE-Is were compared to the NoCACE-I group , a significant reduction in the rate of decline in ADLs ( median one versus four points ) , were only observed for perindopril , p = 0.01 .
RESULTS	The CDR-SB was also reduced ( median one-point ) for the perindopril compared to the NoCACE-I group , p = 0.04 .
CONCLUSIONS	This observational study suggests that CACE-Is , and potentially perindopril in particular , are associated with a reduced rate of functional decline in patients with AD , without an association with mood or behavior .
CONCLUSIONS	This suggests that CACE-Is may slow disease progression in AD .

###24499394
BACKGROUND	Family caregivers of patients with dementia frequently experience psychological stress , depression and disturbed psychophysiological activity , with increased levels of diurnal cortisol secretion .
OBJECTIVE	To compare the effects of a cognitive-behavioural group therapy ( CBT ) to a psychoeducation group programme ( EDUC ) on cortisol secretion in caregivers of patients with moderate Alzheimer 's disease ( AD ) .
METHODS	Caregivers of AD outpatients were semi-randomly allocated to one of two intervention programmes ( CBT or EDUC ) consisting of eight weekly sessions .
METHODS	Twenty-six participants completed the study .
METHODS	Before and after intervention , salivary cortisol was collected at four different times of the day .
METHODS	Effects of the interventions were evaluated with self-report psychological scales and questionnaires related to functional abilities and neuropsychiatric symptoms of the AD relative .
RESULTS	Only in the CBT group did salivary cortisol levels significantly decrease after intervention , with a large effect size and high achieved power .
RESULTS	Both groups reported a reduction of neuropsychiatric symptoms of their AD relative after intervention .
CONCLUSIONS	Psychoeducation for caregivers may contribute to a reduction of neuropsychiatric symptoms of AD patients while CBT additionally attenuates psychophysiological responses to stressful situations in caregivers , by reducing diurnal cortisol levels .
CONCLUSIONS	This may lead to a positive impact in the general health of the caregiver , eventually resulting in better care of the AD patient .

###25547776
BACKGROUND	Transcranial direct current stimulation ( tDCS ) enhances treatment outcomes post-stroke .
BACKGROUND	Feasibility and tolerability of high-definition ( HD ) tDCS ( a technique that increases current focality and intensity ) for consecutive weekdays as an adjuvant to behavioral treatment in a clinical population has not been demonstrated .
OBJECTIVE	To determine HD-tDCS feasibility outcomes : 1 ) ability to implement study as designed , 2 ) acceptability of repeated HD-tDCS administration to patients , and 3 ) preliminary efficacy .
METHODS	Eight patients with chronic post-stroke aphasia participated in a randomized crossover trial with two arms : conventional sponge-based ( CS ) tDCS and HD-tDCS .
METHODS	Computerized anomia treatment was administered for five consecutive days during each treatment arm .
RESULTS	Individualized modeling/targeting procedures and an 8-channel HD-tDCS device were developed .
RESULTS	CS-tDCS and HD-tDCS were comparable in terms of implementation , acceptability , and outcomes .
RESULTS	Naming accuracy and response time improved for both stimulation conditions .
RESULTS	Change in accuracy of trained items was numerically higher ( but not statistically significant ) for HD-tDCS compared to CS-tDCS for most patients .
CONCLUSIONS	Regarding feasibility , HD-tDCS treatment studies can be implemented when designed similarly to documented CS-tDCS studies .
CONCLUSIONS	HD-tDCS is likely to be acceptable to patients and clinicians .
CONCLUSIONS	Preliminary efficacy data suggest that HD-tDCS effects , using only 4 electrodes , are at least comparable to CS-tDCS .

###24902481
BACKGROUND	Implementation of trial interventions is rarely assessed , despite its effects on findings .
BACKGROUND	We assessed the implementation of a nurse-led intervention to facilitate medication adherence in type 2 diabetes ( SAMS ) in a trial against standard care in general practice .
BACKGROUND	The intervention increased adherence , but not through the hypothesised psychological mechanism .
BACKGROUND	This study aimed to develop a reliable coding frame for tape-recorded consultations , assessing both a priori hypothesised and potential active ingredients observed during implementation , and to describe the delivery and receipt of intervention and standard care components to understand how the intervention might have worked .
METHODS	211 patients were randomised to intervention or comparison groups and 194/211 consultations were tape-recorded .
METHODS	Practice nurses delivered standard care to all patients and motivational and action planning ( implementation intention ) techniques to intervention patients only .
METHODS	The coding frame was developed and piloted iteratively on selected tape recordings until a priori reliability thresholds were achieved .
METHODS	All tape-recorded consultations were coded and a random subsample double-coded .
RESULTS	Nurse communication , nurse-patient relationship and patient responses were identified as potential active ingredients over and above the a priori hypothesised techniques .
RESULTS	The coding frame proved reliable .
RESULTS	Intervention and standard care were clearly differentiated .
RESULTS	Nurse protocol adherence was good ( M ( SD ) = 3.95 ( 0.91 ) ) and competence of intervention delivery moderate ( M ( SD ) = 3.15 ( 1.01 ) ) .
RESULTS	Nurses frequently reinforced positive beliefs about taking medication ( e.g. , 65 % for advantages ) but rarely prompted problem solving of negative beliefs ( e.g. , 21 % for barriers ) .
RESULTS	Patients ' action plans were virtually identical to current routines .
RESULTS	Nurses showed significantly less patient-centred communication with the intervention than comparison group .
CONCLUSIONS	It is feasible to reliably assess the implementation of behaviour change interventions in clinical practice .
CONCLUSIONS	The main study results could not be explained by poor delivery of motivational and action planning components , definition of new action plans , improved problem solving or patient-centred communication .
CONCLUSIONS	Possible mechanisms of increased medication adherence include spending more time discussing it and mental rehearsal of successful performance of current routines , combined with action planning .
CONCLUSIONS	Delivery of a new behaviour change intervention may lead to less patient-centred communication and possible reduction in overall trial effects .
BACKGROUND	ISRCTN30522359 .

###25499165
BACKGROUND	Blood transfusion might affect long-term mortality by changing immune function and thus potentially increasing the risk of subsequent infections and cancer recurrence .
BACKGROUND	Compared with a restrictive transfusion strategy , a more liberal strategy could reduce cardiac complications by lowering myocardial damage , thereby reducing future deaths from cardiovascular disease .
BACKGROUND	We aimed to establish the effect of a liberal transfusion strategy on long-term survival compared with a restrictive transfusion strategy .
METHODS	In the randomised controlled FOCUS trial , adult patients aged 50 years and older , with a history of or risk factors for cardiovascular disease , and with postoperative haemoglobin concentrations lower than 100 g/L within 3 days of surgery to repair a hip fracture , were eligible for enrolment .
METHODS	Patients were recruited from 47 participating hospitals in the USA and Canada , and eligible participants were randomly allocated in a 1:1 ratio by a central telephone system to either liberal transfusion in which they received blood transfusion to maintain haemoglobin level at 100 g/L or higher , or restrictive transfusion in which they received blood transfusion when haemoglobin level was lower than 80 g/L or if they had symptoms of anaemia .
METHODS	In this study , we analysed the long-term mortality of patients assigned to the two transfusion strategies , which was a secondary outcome of the FOCUS trial .
METHODS	Long-term mortality was established by linking the study participants to national death registries in the USA and Canada .
METHODS	Treatment assignment was not masked , but investigators who ascertained mortality and cause of death were masked to group assignment .
METHODS	Analyses were by intention to treat .
METHODS	The FOCUS trial is registered with ClinicalTrials.gov , number NCT00071032 .
RESULTS	Between July 19 , 2004 , and Feb 28 , 2009 , 2016 patients were enrolled and randomly assigned to the two treatment groups : 1007 to the liberal transfusion strategy and 1009 to the restrictive transfusion strategy .
RESULTS	The median duration of follow-up was 31 years ( IQR 24-41 years ) , during which 841 ( 42 % ) patients died .
RESULTS	Long-term mortality did not differ significantly between the liberal transfusion strategy ( 432 deaths ) and the restrictive transfusion strategy ( 409 deaths ) ( hazard ratio 109 [ 95 % CI 095-125 ] ; p = 021 ) .
CONCLUSIONS	Liberal blood transfusion did not affect mortality compared with a restrictive transfusion strategy in a high-risk group of elderly patients with underlying cardiovascular disease or risk factors .
CONCLUSIONS	The underlying causes of death did not differ between the trial groups .
CONCLUSIONS	These findings do not support hypotheses that blood transfusion leads to long-term immunosuppression that is severe enough to affect long-term mortality rate by more than 20-25 % or cause of death .
BACKGROUND	National Heart , Lung , and Blood Institute .

###25363062
OBJECTIVE	The study aimed to evaluate the effects of probiotic Lactobacillus reuteri DSM 17938 strain supplementation in patients suffering from systemic nickel allergy syndrome , in terms of modulation of faecal LAB population linked to a reduction of GI and cutaneous symptoms and to an increase of patient 's quality of life .
RESULTS	A preliminary double-blind randomized placebo-controlled study was planned and a culture-independent method based on denaturing gradient gel electrophoresis ( DGGE ) analysis coupled to the 16S rRNA gene sequencing was applied to investigate on the dynamics of faecal LAB communities before and during a low-Ni diet , supplemented with the probiotic strain .
RESULTS	Moreover , the severity and the frequency of GI and cutaneous reactions as well as patient 's clinical condition perception ( VAS scores ) were estimated by statistical analysis .
RESULTS	PCR-DGGE fingerprinting obtained using LAB-specific primers revealed significant shift in faecal community with an increase in biodiversity in patients supplemented with probiotic Lact.reuteri strain .
RESULTS	In addition , GI reactions such as symptoms related to meals and type of stools significantly improved only in patients treated with Lact.reuteri , while severity and frequency of cutaneous symptoms ( urticaria , itch and eczema ) and recurrent abdominal pain ( RAP ) as well as VAS scores statistically decreased in both groups .
CONCLUSIONS	Our preliminary findings suggest that probiotic Lact.reuteri could be a useful supplementation during a low-Ni diet of patients with SNAS , to increase LAB population diversity , which could contribute to restore the intestinal homoeostasis conditions .
CONCLUSIONS	To date , no information is available on probiotics application and on their effects , in terms of intestinal microbiota modulation , on patients suffering from SNAS .
CONCLUSIONS	Therefore , the identification of dominant LAB community and the study of its shift during the probiotic supplementation could enhance the knowledge of the SNAS syndrome .

###24720927
OBJECTIVE	The authors hypothesized that the women enrolled in the HF-ACTION ( Heart Failure-A Controlled Trial Investigating Outcomes of Exercise TraiNing ) trial and randomly assigned to exercise training ( ET ) would improve functional capacity as measured by peak oxygen uptake ( VO2 ) compared with those in the usual care group .
OBJECTIVE	Furthermore , they hypothesized that the improvement in peak VO2 would correlate with prognosis .
OBJECTIVE	They explored whether exercise had a differential effect on outcomes in women versus men .
BACKGROUND	There is less evidence for the benefit of ET in women with heart failure ( HF ) compared with men because of the small numbers of women studied .
METHODS	HF-ACTION was a randomized trial of ET versus usual care in 2,331 patients with class II-IV HF and a left ventricular ejection fraction of 35 % .
METHODS	Sex differences in the effects of randomized treatment on clinical outcomes were assessed through the use of a series of Cox proportional hazards models , controlling for covariates known to affect prognosis in HF-ACTION .
RESULTS	Women had lower baseline peak VO2 and 6-min walk distance than did men ( median , 13.4 vs. 14.9 ml/min/kg and 353 vs. 378 m , respectively ) .
RESULTS	An increase in peak VO2 at 3 months was present in women and men in the ET group ( mean SD ; median , 0.88 2.2 , 0.80 and 0.77 2.7 , 0.60 , respectively , women vs. men ; p = 0.42 ) .
RESULTS	Women randomly assigned to ET had a significant reduction in the primary endpoint , ( hazard ratio : 0.74 ) compared with men ( hazard ratio : 0.99 ) randomly assigned to ET , with a significant treatment-by-sex interaction ( p = 0.027 ) .
CONCLUSIONS	Although there is no significant difference between men and women in the effect of ET on peak VO2 change at 3 months , ET in women with HF is associated with a larger reduction in rate of the combined endpoint of all-cause mortality and hospital stay than in men .

###25064777
OBJECTIVE	To investigate the effectiveness of mirror therapy ( MT ) combined with bilateral arm training and graded activities to improve motor performance in the paretic upper limb after stroke .
METHODS	Randomized , controlled , assessor-blinded study .
METHODS	Inpatient stroke rehabilitation center of a tertiary care teaching hospital .
METHODS	Patients with first-time ischemic or hemorrhagic stroke ( N = 20 ) , confined to the territory of the middle cerebral artery , occurring < 6 months before the commencement of the study .
METHODS	The MT and control group participants underwent a patient-specific multidisciplinary rehabilitation program including conventional occupational therapy , physical therapy , and speech therapy for 5 d/wk , 6 h/d , over 3 weeks .
METHODS	The participants in the MT group received 1 hour of MT in addition to the conventional stroke rehabilitation .
METHODS	The Upper Extremity Fugl-Meyer Assessment for motor recovery , Brunnstrom stages of motor recovery for the arm and hand , Box and Block Test for gross manual hand dexterity , and modified Ashworth scale to assess the spasticity .
RESULTS	After 3 weeks of MT , mean change scores were significantly greater in the MT group than in the control group for the Fugl-Meyer Assessment ( P = .008 ) , Brunnstrom stages of motor recovery for the arm ( P = .003 ) and hand ( P = .003 ) , and the Box and Block Test ( P = .022 ) .
RESULTS	No significant difference was found between the groups for modified Ashworth scale ( P = .647 ) .
CONCLUSIONS	MT when combined with bilateral arm training and graded activities was effective in improving motor performance of the paretic upper limb after stroke compared with conventional therapy without MT.

###24697952
OBJECTIVE	To evaluate the effect of leukoreduction ( LR ) as compared to standard nonleukoreduced ( NLR ) units on cytokine concentrations in canine erythrocyte concentrates during regular storage time .
METHODS	Randomized , experimental study .
METHODS	University teaching hospital .
METHODS	Ten random-source research dogs .
METHODS	One unit of whole blood was collected from each dog and randomized to standard processing ( NLR , n = 5 ) or prestorage LR ( n = 5 ) .
METHODS	All units were stored at 4C .
METHODS	Samples were aseptically collected from each unit weekly for 5 weeks .
METHODS	On day 35 , 1 mL of blood was collected from each unit and submitted for aerobic culture .
RESULTS	An ELISA assay was used to analyze the concentrations of IL-1 , IL-8 , TNF - , and IL-10 .
RESULTS	There were no significant effects of either group or storage time for IL-1 , IL-10 , or TNF - .
RESULTS	IL-8 concentration was significantly increased over the storage period in NLR units , and was significantly higher compared to LR units on days 28 and 35 .
RESULTS	Aerobic culture was negative on all units .
CONCLUSIONS	This study demonstrated a marked , storage time-dependent accumulation of IL-8 in canine erythrocyte concentrates .
CONCLUSIONS	Prestorage LR attenuated the accumulation of IL-8 .
CONCLUSIONS	This chemokine may contribute to the proinflammatory effects of transfusion of stored erythrocyte concentrates .

###24344111
BACKGROUND	Research suggests that hypertonic saline ( HS ) may improve mucous flow in infants with acute bronchiolitis .
BACKGROUND	Data suggest a trend favoring reduced length of hospital stay and improved pulmonary scores with increasing concentration of nebulized solution to 3 % and 5 % saline as compared with 0.9 % saline mixed with epinephrine .
BACKGROUND	To our knowledge , 7 % HS has not been previously investigated .
METHODS	We conducted a prospective , double-blind , randomized controlled trial in 101 infants presenting with moderate to severe acute bronchiolitis .
METHODS	Subjects received either 7 % saline or 0.9 % saline , both with epinephrine .
METHODS	Our primary outcome was a change in bronchiolitis severity score ( BSS ) , obtained before and after treatment , and at the time of disposition from the emergency department ( ED ) .
METHODS	Secondary outcomes measured were hospitalization rate , proportion of admitted patients discharged at 23 hours , and ED and inpatient length of stay .
RESULTS	At baseline , study groups were similar in demographic and clinical characteristics .
RESULTS	The decrease in mean BSS was not statistically significant between groups ( 2.6 vs 2.4 for HS and control groups , respectively ) .
RESULTS	The difference between the groups in proportion of admitted patients ( 42 % in HS versus 49 % in normal saline ) , ED or inpatient length of stay , and proportion of admitted patients discharged at 23 hours was not statistically significant .
CONCLUSIONS	In moderate to severe acute bronchiolitis , inhalation of 7 % HS with epinephrine does not appear to confer any clinically significant decrease in BSS when compared with 0.9 % saline with epinephrine .

###24348043
OBJECTIVE	Chronic hemodialysis patients experience accelerated atherosclerosis contributed to by dyslipidemia , inflammation , and an impaired antioxidant system .
OBJECTIVE	Vitamin E tocotrienols possess anti-inflammatory and antioxidant properties .
OBJECTIVE	However , the impact of dietary intervention with Vitamin E tocotrienols is unknown in this population .
METHODS	A randomized , double-blind , placebo-controlled , parallel trial was conducted in 81 patients undergoing chronic hemodialysis .
METHODS	Subjects were provided daily with capsules containing either vitamin E tocotrienol-rich fraction ( TRF ) ( 180 mg tocotrienols , 40 mg tocopherols ) or placebo ( 0.48 mg tocotrienols , 0.88 mg tocopherols ) .
METHODS	Endpoints included measurements of inflammatory markers ( C-reactive protein and interleukin 6 ) , oxidative status ( total antioxidant power and malondialdehyde ) , lipid profiles ( plasma total cholesterol , triacylglycerols , and high-density lipoprotein cholesterol ) , as well as cholesteryl-ester transfer protein activity and apolipoprotein A1 .
RESULTS	TRF supplementation did not impact any nutritional , inflammatory , or oxidative status biomarkers over time when compared with the baseline within the group ( one-way repeated measures analysis of variance ) or when compared with the placebo group at a particular time point ( independent t-test ) .
RESULTS	However , the TRF supplemented group showed improvement in lipid profiles after 12 and 16 weeks of intervention when compared with placebo at the respective time points .
RESULTS	Normalized plasma triacylglycerols ( cf baseline ) in the TRF group were reduced by 33 mg/dL ( P = 0.032 ) and 36 mg/dL ( P = 0.072 ) after 12 and 16 weeks of intervention but no significant improvement was seen in the placebo group .
RESULTS	Similarly , normalized plasma high-density lipoprotein cholesterol was higher ( P < 0.05 ) in the TRF group as compared with placebo at both week 12 and week 16 .
RESULTS	The changes in the TRF group at week 12 and week 16 were associated with higher plasma apolipoprotein A1 concentration ( P < 0.02 ) and lower cholesteryl-ester transfer protein activity ( P < 0.001 ) .
CONCLUSIONS	TRF supplementation improved lipid profiles in this study of maintenance hemodialysis patients .
CONCLUSIONS	A multi-centered trial is warranted to confirm these observations .

###24365167
BACKGROUND	There are limited data on the efficacy of early fluid resuscitation with third-generation hydroxyethyl starch ( HES 130 ) in burn injury .
BACKGROUND	Adverse effects of HES on survival and organ function have been reported .
METHODS	In this randomized , controlled , double-blind trial , 48 patients with severe burn injury were assigned to receive either lactated Ringer 's solution plus 6 % HES 130/0 .4 in a ratio of 2:1 or lactated Ringer 's solution with no colloid supplement for the first 72 hours .
METHODS	Primary outcome parameter was the group difference of administered total fluid from intensive care unit ( ICU ) admission up to day 3 .
METHODS	Secondary outcomes included kidney and lung injury and failure , length of stay , and mortality .
RESULTS	Three-day totals of administered resuscitation fluid ( medians ) were 21,190 mL in the lactated Ringer 's group and 19,535 mL in the HES group ( HES : -1,213 mL ; P = 0.39 ) .
RESULTS	Creatinine levels from day 1 to 3 ( HES : +0.4 mol/L ; 95 % confidence interval ( CI ) -18.7 to 19.5 ; P = 0.97 ) and urinary outputs from day 1 to 3 ( HES : -58 mL ; 95 % CI -400 to 283 ; P = 0.90 ) were not different .
RESULTS	Six patients in each group developed acute respiratory distress syndrome ( ARDS ) ( risk ratio 0.96 ; 95 % CI 0.35 to 2.64 ; P = 0.95 ) .
RESULTS	Length of ICU stay ( HES vs. lactated Ringer 's : 28 vs. 24 days ; P = 0.80 ) and length of hospital stay ( 31 vs. 29 days ; P = 0.57 ) were similar .
RESULTS	Twenty-eight-day mortality was 4 patients in each group ( risk ratio 0.96 ; 95 % CI 0.27 to 4.45 ; P = 0.95 ) , and in-hospital mortality was 8 in the HES group vs. 5 patients in the lactated Ringer 's group ( hazard ratio 1.86 ; 95 % CI 0.56 to 6.19 ; P = 0.31 ) .
CONCLUSIONS	There was no evidence that early fluid resuscitation with balanced HES 130/0 .4 ( 6 % ) in addition to lactated Ringer 's solution would lead to a volume-sparing effect in severe burn injury .
CONCLUSIONS	Together with the findings that early renal function , incidence of ARDS , length of stay , and mortality were not negatively influenced by HES in this setting , balanced HES 130/0 .4 ( 6 % ) plus lactated Ringer 's solution could not be considered superior to lactated Ringer 's solution alone .
BACKGROUND	ClinicalTrials.gov NCT01012648 .

###24378101
OBJECTIVE	The purpose of this study was to investigate the efficacy and mechanism of oxaliplatin in combination with capecitabine ( XELOX ) regimen as neoadjuvant chemotherapy in the treatment of patients with advanced gastric cancer .
METHODS	Eighty-five patients with advanced gastric cancer ( stage IIB and IIIC ) were randomly divided into two groups : neoadjuvant chemotherapy group ( 40 cases ) and surgery alone group ( 45 cases ) .
METHODS	In the neoadjuvant chemotherapy group , patients received oral administration of Xeloda 1000 mg/m ( 2 ) twice a day on days 1-14 and intravenous infusion of oxaliplatin 130 mg/m ( 2 ) on day 1 ( XELOX regimen ) .
METHODS	The regimen was repeated every 21 days .
METHODS	In the surgery alone group , patients directly received radical resection of gastric cancer .
METHODS	The R0 resection rate , overall survival and disease free survival ( DFS ) were observed in all cases .
METHODS	The cycles and apoptosis rate of the gastric cancer cells were detected by flow cytometry .
METHODS	The expression of proliferating cell nuclear antigen ( PCNA ) , p21 , p53 and survivin was detected by Western blot .
RESULTS	In the neoadjuvant chemotherapy group , the total effective rate was 32.5 % ( 13/40 ) , and the tumor control rate was 90 % ( 36/40 ) , with few side effects .
RESULTS	Compared with the surgery alone group , R0 resection rate was significantly higher in the neoadjuvant chemotherapy group ( P < 0.05 ) .
RESULTS	The survival analysis indicated that both the overall survival and DFS were longer in the neoadjuvant chemotherapy group in comparison with those in the surgery alone group , but no significant differences were found ( P > 0.05 ) .
RESULTS	In the neoadjuvant chemotherapy group , both the apoptosis rate and the ratio of cells in stage G0 and G1 were significantly higher than those in the surgery alone group ( P < 0.05 ) .
RESULTS	The expression of PCNA and survivin was lower in the neoadjuvant chemotherapy group , while the expression of p21 and p53 was higher .
CONCLUSIONS	XELOX regimen as neoadjuvant chemotherapy in the treatment of patients with advanced gastric cancer can effectively improve the R0 resection rate and prolong the survival time of the patients .
CONCLUSIONS	Its mechanism is probably that the neoadjuvant chemotherapy can markedly enhance apoptosis in gastric cancer cells and inhibit their proliferation .

###25818060
BACKGROUND	Despite the growing prevalence of prescription opioid dependence , longitudinal studies have not examined long-term treatment response .
BACKGROUND	The current study examined outcomes over 42 months in the Prescription Opioid Addiction Treatment Study ( POATS ) .
METHODS	POATS was a multi-site clinical trial lasting up to 9 months , examining different durations of buprenorphine-naloxone plus standard medical management for prescription opioid dependence , with participants randomized to receive or not receive additional opioid drug counseling .
METHODS	A subset of participants ( N = 375 of 653 ) enrolled in a follow-up study .
METHODS	Telephone interviews were administered approximately 18 , 30 , and 42 months after main-trial enrollment .
METHODS	Comparison of baseline characteristics by follow-up participation suggested few differences .
RESULTS	At Month 42 , much improvement was seen : 31.7 % were abstinent from opioids and not on agonist therapy ; 29.4 % were receiving opioid agonist therapy , but met no symptom criteria for current opioid dependence ; 7.5 % were using illicit opioids while on agonist therapy ; and the remaining 31.4 % were using opioids without agonist therapy .
RESULTS	Participants reporting a lifetime history of heroin use at baseline were more likely to meet DSM-IV criteria for opioid dependence at Month 42 ( OR = 4.56 , 95 % CI = 1.29-16 .04 , p < .05 ) .
RESULTS	Engagement in agonist therapy was associated with a greater likelihood of illicit-opioid abstinence .
RESULTS	Eight percent ( n = 27/338 ) used heroin for the first time during follow-up ; 10.1 % reported first-time injection heroin use .
CONCLUSIONS	Long-term outcomes for those dependent on prescription opioids demonstrated clear improvement from baseline .
CONCLUSIONS	However , a subset exhibited a worsening course , by initiating heroin use and/or injection opioid use .

###26163088
OBJECTIVE	To identify dosimetry , clinical factors and medication intake impacting urinary symptoms after prostate radiotherapy .
METHODS	Data describing clinical factors and bladder dosimetry ( reduced with principal component ( PC ) analysis ) for 754 patients treated with external beam radiotherapy accrued by TROG 03.04 RADAR prostate radiotherapy trial were available for analysis .
METHODS	Urinary symptoms ( frequency , incontinence , dysuria and haematuria ) were prospectively assessed using LENT-SOMA to a median of 72months .
METHODS	The endpoints assessed were prevalence ( grade 1 ) at the end of radiotherapy ( representing acute symptoms ) , at 18 - , 36 - and 54-month follow-ups ( representing late symptoms ) and peak late incidence including only grade 2 .
METHODS	Impact of factors was assessed using multivariate logistic regression models with correction for over-optimism .
RESULTS	Baseline symptoms , non-insulin dependent diabetes mellitus , age and PC1 ( correlated to the mean dose ) impact symptoms at > 1 timepoints .
RESULTS	Associations at a single timepoint were found for cerebrovascular condition , ECOG status and non-steroidal anti-inflammatory drug intake .
RESULTS	Peak incidence analysis shows the impact of baseline , bowel and cerebrovascular condition and smoking status .
CONCLUSIONS	The prevalence and incidence analysis provide a complementary view for urinary symptom prediction .
CONCLUSIONS	Sustained impacts across time points were found for several factors while some associations were not repeated at different time points suggesting poorer or transient impact .

###25318029
BACKGROUND	Medical students experience a high burden of stress and suffer elevated rates of depression , burnout , and suicide compared to the general population , yet there is no consensus on how to address student wellness .
OBJECTIVE	The purpose of this study was to determine whether an abridged mindfulness based stress reduction ( MBSR ) intervention can improve measures of wellness in a randomized sample of 1st-year medical students .
METHODS	Fifty-eight participants were randomized to control or 8-week MBSR intervention and then invited to participate in the study .
METHODS	All participants were assessed using the Perceived Stress Scale ( PSS ) , the Resilience Scale ( RS ) , and Self-Compassion Scale ( SCS ) at 3 separate time points : baseline , at the conclusion of the study intervention ( 8 weeks ) , and at 6 months after the conclusion of the intervention .
METHODS	The intervention consisted of 75 minutes of weekly class time , suggested meditation at home , and a half-day retreat in the last week .
RESULTS	The intervention group achieved significant increase on SCS scores both at the conclusion of the study ( 0.58 , p = .002 ) , 95 % confidence interval ( CI ) [ 0.23 , 0.92 ] , and at 6 months ( 0.56 , p = .001 ) , 95 % CI [ 0.25 , 0.87 ] .
RESULTS	PSS scores achieved significant reduction at the conclusion of the study ( 3.63 , p = .03 ) , 95 % CI [ 0.37 , 6.89 ] , but not at 6 months poststudy ( 2.91 , p = .08 ) , 95 % CI [ -0.37 , 6.19 ] .
RESULTS	The study did not demonstrate a difference in RS after the intervention , though RS was significantly correlated with both SCS and PSS .
CONCLUSIONS	An abridged MBSR intervention improves perceived stress and self-compassion in 1st-year medical students and may be a valuable curricular tool to enhance wellness and professional development .

###24965202
OBJECTIVE	Results from this randomized , placebo-controlled study of aripiprazole augmentation to antidepressant therapy ( ADT ) in Japanese patients with major depressive disorder ( MDD ) ( the Aripiprazole Depression Multicenter Efficacy [ ADMIRE ] study ) revealed that aripiprazole augmentation was superior to ADT alone and was well tolerated .
OBJECTIVE	In subgroup analyses , we investigated the influence of demographic - and disease-related factors on the observed responses .
OBJECTIVE	We also examined how individual symptom improvement was related to overall improvement in MDD .
METHODS	Data from the ADMIRE study were analyzed .
METHODS	Subgroup analyses were performed on the primary outcome measures : the mean change in the Montgomery-sberg Depression Rating Scale ( MADRS ) total score from the end of selective serotonin reuptake inhibitor ( SSRI ) / serotonin norepinephrine reuptake inhibitor ( SNRI ) treatment to the end of the randomized treatment .
RESULTS	Changes in the MADRS total scores were consistently greater with aripiprazole than placebo in each of the subgroups .
RESULTS	Efficacy was not related to sex , age , number of adequate ADT trials in the current episode , MDD diagnosis , number of depressive episodes , duration of the current episode , age at first depressive episode , time since the first depressive episode , type of SSRI/SNRI , or severity at the end of SSRI/SNRI treatment phase .
RESULTS	Compared to placebo , aripiprazole resulted in significant and rapid improvement on seven of the 10 MADRS items , including sadness .
CONCLUSIONS	These post-hoc analyses indicated that aripiprazole was effective for a variety of Japanese patients with MDD who had exhibited inadequate responses to ADT .
CONCLUSIONS	Additionally , we suggest that aripiprazole significantly and rapidly improved the core depressive symptoms .

###25301965
BACKGROUND	Active virtual reality gaming ( AVG ) may be useful for children with developmental coordination disorder ( DCD ) to practice motor skills if their movement patterns are of good quality while engaged in AVG .
OBJECTIVE	This study aimed to examine : ( 1 ) the quality of motor patterns of children with DCD participating in AVG by comparing them with children with typical development ( TD ) and ( 2 ) whether differences existed in the motor patterns utilized with 2 AVG types : Sony PlayStation 3 Move and Microsoft Xbox 360 Kinect .
METHODS	This was a quasi-experimental , biomechanical laboratory-based study .
METHODS	Twenty-one children with DCD , aged 10 to 12 years , and 19 age - and sex-matched children with TD played a match of table tennis on each AVG type .
METHODS	Hand path , wrist angle , and elbow angle were recorded using a motion analysis system .
METHODS	Linear mixed-model analyses were used to determine differences between DCD and TD groups and Move and Kinect AVG type for forehands and backhands .
RESULTS	Children with DCD utilized a slower hand path speed ( backhand mean difference [ MD ] = 1.20 m/s ; 95 % confidence interval [ 95 % CI ] = 0.41 , 1.98 ) ; greater wrist extension ( forehand MD = 34.3 ; 95 % CI = 22.6 , 47.0 ) ; and greater elbow flexion ( forehand MD = 22.3 ; 95 % CI = 7.4 , 37.1 ) compared with children with TD when engaged in AVG .
RESULTS	There also were differences in movement patterns utilized between AVG types .
CONCLUSIONS	Only simple kinematic measures were compared , and no data regarding movement outcome were assessed .
CONCLUSIONS	If a therapeutic treatment goal is to promote movement quality in children with DCD , clinical judgment is required to select the most appropriate AVG type and determine whether movement quality is adequate for unsupervised practice .

###25068637
OBJECTIVE	To evaluate intravitreal aflibercept for treatment of macular edema secondary to central retinal vein occlusion ( CRVO ) .
METHODS	Randomized , double-masked , phase 3 study .
METHODS	A total of 177 patients with macular edema secondary to CRVO were randomized to receive 2 mg intravitreal aflibercept ( n = 106 ) or sham ( n = 71 ) every 4 weeks for 20 weeks .
METHODS	From weeks 24 to 48 , patients were monitored every 4 weeks ; the former group received intravitreal aflibercept as needed ( PRN ) , and the sham group received sham .
METHODS	From weeks 52 to 76 , patients were monitored every 8 weeks , and both groups received intravitreal aflibercept PRN .
METHODS	The primary endpoint ( proportion of patients who gained 15 letters ) was at week 24 .
METHODS	This study reports exploratory outcomes at week 76 .
RESULTS	The proportion of patients who gained 15 letters in the intravitreal aflibercept and sham groups was 60.2 % vs 22.1 % at week 24 ( patients discontinued before week 24 were considered nonresponders ; P < .0001 ) , 60.2 % vs 32.4 % at week 52 ( last observation carried forward , P < .001 ) , and 57.3 % vs 29.4 % at week 76 ( last observation carried forward ; P < .001 ) .
RESULTS	Mean m change from baseline central retinal thickness was -448.6 vs -169.3 at week 24 ( P < .0001 ) , -423.5 vs -219.3 at week 52 ( P < .0001 ) , and -389.4 vs -306.4 at week 76 ( P = .1122 ) .
RESULTS	Over 76 weeks , the most common ocular serious adverse event in the intravitreal aflibercept group was macular edema ( 3.8 % ) .
CONCLUSIONS	The visual and anatomic improvements seen after fixed , monthly dosing at week 24 were largely maintained when treatment intervals were extended .
CONCLUSIONS	Patients with macular edema following CRVO benefited from early treatment with intravitreal aflibercept .

###25673037
BACKGROUND	In Crohn 's disease patients failing infliximab therapy , interventions defined by an algorithm based on infliximab and anti-infliximab antibody measurements have proven more cost-effective than intensifying the infliximab regimen .
OBJECTIVE	This study investigated long-term economic outcomes at the week 20 follow-up study visit and after 1 year .
OBJECTIVE	Clinical outcomes were assessed at week 20 .
METHODS	Follow-up from a 12-week , single-blind , clinical trial where patients with infliximab treatment failure were randomized to infliximab intensification ( 5 mg/kg every 4 weeks ) ( n = 36 ) , or algorithm-defined interventions ( n = 33 ) .
METHODS	Accumulated costs , expressed as mean costs per patient , were based on the Danish National Patient Registry .
RESULTS	At the scheduled week 20 follow-up study visit , response and remission rates were similar in all study subpopulations between patients treated by the algorithm or by infliximab intensification .
RESULTS	However , the sum of healthcare costs related to Crohn 's disease was substantially lower ( 31 % ) for patients randomized to algorithm-based interventions than infliximab intensification in the intention-to-treat population : $ 11,940 versus $ 17,236 ; p = 0.005 .
RESULTS	For per-protocol patients ( n = 55 ) , costs at the week 20 follow-up visit were even lower ( 49 % ) in the algorithm group : $ 8,742 versus $ 17,236 ; p = 0.002 .
RESULTS	Figures were similar for patients having completed the 12-week trial as per protocol ( 50 % reduction in costs ) ( n = 45 ) .
RESULTS	Among patients continuing the allocated study intervention throughout the entire 20-week follow-up period ( n = 29 ) , costs were reduced by 60 % in algorithm-treated patients : $ 7,056 versus $ 17,776 ; p < 0.001 .
RESULTS	Cost-reduction percentages remained stable throughout one year .
CONCLUSIONS	Economic benefit of algorithm-based interventions at infliximab failure is maintained throughout 1 year .

###24342146
OBJECTIVE	H19 is a paternally imprinted oncofetal gene expressed in various embryonic tissues and in 85 % of bladder tumors but suppressed in the adult healthy bladder .
OBJECTIVE	BC-819 is a DNA plasmid that carries the gene for diphtheria toxin-A under regulation of the H19 promoter sequence .
OBJECTIVE	We assessed the efficacy and toxicity of intravesical BC-819 instillations to prevent tumor recurrence and ablate a marker lesion in a phase 2b trial .
METHODS	A total of 47 patients with recurrent , multiple nonmuscle invasive bladder tumors in whom prior intravesical therapy had failed underwent transurethral resection of all except 1 marker tumor .
METHODS	Patients expressing H19 received a 6-week induction course of intravesical BC-819 .
METHODS	Patients who achieved a complete response ( absent new tumors at 3 months ) were given 3 maintenance courses of 3-weekly instillations every 3 months .
RESULTS	All patients were evaluable for adverse effects and 39 were evaluable forefficacy .
RESULTS	Complete tumor ablation was achieved in 33 % of patients and in 64 % there were no new tumors at 3 months .
RESULTS	Median time to recurrence was 11.3 months in all cases but significantly longer ( 22.1 months ) when analyzed byresponse status at 3 months .
RESULTS	Adverse events were mild .
RESULTS	The study was limited by the small number of patients .
CONCLUSIONS	BC-819 prevented new tumor growth in two-thirds of the patients and ablated a third of the marker lesions .
CONCLUSIONS	Prolonged time to recurrence was observed in responding patients .
CONCLUSIONS	These results along with the good safety profile make BC-819 a potential medication for bladder cancer .

###24606622
BACKGROUND	Conducting research in real life settings ( effectiveness studies ) can introduce many confounding factors .
BACKGROUND	Efficacy studies seek to control for researcher bias and data quality rather than considering how the efficacy of an intervention is changed by the contexts in which it is used .
BACKGROUND	Relatively little is known about the impact of context on educational interventions , in particular on multimedia learning .
METHODS	An effectiveness study to understand implementation variance of online educational modules in surgery clerkships was conducted in six US medical schools participating in an efficacy trial of different multimedia designs .
METHODS	Student and teacher experiences were captured through focus groups and one-to-one interviews with trial participants and their teachers .
METHODS	Audio-recordings of these sessions were transcribed and analysed using grounded theory techniques .
RESULTS	Differences were identified in student and teacher perceptions of how the educational intervention had been implemented and how its uptake had been influenced by context-dependent factors : ( i ) the intervention was implemented in different ways to suit different educational contexts and this influenced how students and teachers responded to it ; ( ii ) the ways students and teachers interacted with , and behaved around , the intervention influenced its uptake ; ( iii ) the way the intervention was perceived by students and teachers influenced its uptake ; and ( iv ) the medium and design of the intervention had a directing influence on its uptake .
CONCLUSIONS	It was observed that each institutional context formed a complex educational ecology .
CONCLUSIONS	The intervention became interwoven with different educational ecologies so that it could no longer be considered a stable variable across the study .
CONCLUSIONS	We suggest that researchers should conduct implementation-profiling studies in advance of any intervention-based research to account for the constructing nature of educational ecologies on their interventions and in doing so to more clearly differentiate between efficacy and effectiveness studies .

###25372911
OBJECTIVE	In this study , we aimed to compare clinical outcomes of superior transseptal approach with the conventional left atriotomy in patients undergoing mitral valve surgery .
METHODS	Between January 2010 and November 2012 , a total of 91 consecutive adult patients ( 39 males , 52 females ; mean age : 54.015.4 years ; range , 16 to 82 years ) who underwent mitral valve surgery in the Division of Cardiovascular Surgery at Kouyolu Training Hospital were included .
METHODS	The patients were randomized to either superior transseptal approach ( n = 47 ) or conventional left atriotomy ( n = 44 ) .
METHODS	Demographic characteristics of the patients , comorbidities , additional interventions , intraoperational data , pre - and postoperative electrophysiological study findings , and postoperative complications were recorded .
RESULTS	Of all patients , 86.7 % ( n = 79 ) were in New York Heart Association Class III , while 12 were in New York Heart Association Class IV .
RESULTS	All patients underwent annuloplasty ( 42.9 % ) or valve replacement surgery ( 57.1 % ) .
RESULTS	There was no significant difference in pre - and postoperative electrocardiogram findings between the groups .
RESULTS	Change from baseline in the cardiac rhythm was statistically significant in superior transseptal approach group alone ( P < 0.001 ) .
RESULTS	There was no statistically significant difference in mortality rate between the groups .
RESULTS	Permanent pacemaker implantation was performed in 10.6 % of the patients in superior transseptal approach group and 4.5 % in the conventional left atriotomy group .
RESULTS	No statistically significant difference in bleeding , total length of hospital and intensive care unit stay , the presence of low cardiac output syndrome was observed between the groups .
CONCLUSIONS	Our study results suggest that superior transseptal approach does not lead to serious or fatal adverse effects on sinus node function or atrial vulnerability , compared to conventional approach .

###25666004
BACKGROUND	Induction of labor for postdate pregnancy using misoprostol is one of the most common interventions in pregnancy .
BACKGROUND	However , the optimal dose of misoprostol is yet to be determined with previous reports utilizing different dosages .
OBJECTIVE	The main objective of this study was to compare the effectiveness and safety of 25 g versus 50 g of intravaginal misoprostol for induction of labor in nulliparous women with postdate pregnancy .
METHODS	This was a prospective study in which 88 nulliparous women with postdate pregnancy were randomly selected to receive either 25 g or 50 g of misoprostol for induction of labor .
METHODS	Student 's t-test and Chi-square test were used to compare proportions .
RESULTS	There was no significant difference between the two groups with regard to the induction-vaginal delivery interval between the two doses .
RESULTS	The proportion of women delivering vaginally with a single dose of misoprostol ( 11/40 vs. 23/43 , P = 0.01 ) and vomiting were significantly greater in the 50 g group .
RESULTS	However , there was no significant difference between both groups in terms of the need for augmentation of labor , caesarean section , tachysystole and hyperstimulation syndrome .
CONCLUSIONS	Intravaginal administration of 25 g of misoprostol appears to be as effective , but safer than 50 g for induction of labor in nulliparous women with postdate pregnancy .

###25365268
OBJECTIVE	Increased recall rates in the Dutch breast cancer screening program call for a new assessment strategy aiming to reduce unnecessary costs and anxiety .
OBJECTIVE	Diagnostic work-up ( usual care ) includes multidisciplinary hospital assessment and is similar for all recalled women , regardless of the radiologist 's suspicion of breast cancer .
OBJECTIVE	This is similar in many Canadian settings .
OBJECTIVE	We developed a novel assessment strategy that offers women with a low suspicion of breast cancer a quick and non-invasive assessment by a screening radiologist ( intervention ) .
OBJECTIVE	We compared these two strategies in a cost-effectiveness analysis based on a randomized controlled trial : multicentre randomized controlled trial ( MASS trial , Netherlands National Trial Register : NTR1480 ) .
METHODS	Participants were enrolled between August 2010 and December 2012 and were randomly assigned to either the intervention or control group ( allocation ratio 2:1 ) .
METHODS	Fourteen assessment centres participated in the study .
METHODS	Questionnaires were used to record quality of life ( EuroQol-5D ) , health care use and costs after recall .
RESULTS	Our study comprised 366 women , of whom 288 were randomly assigned to the intervention group and 88 to the control group .
RESULTS	The mean difference in cost was 153/CAD $ 226 ( 95 % confidence interval 107-199 / CAD $ 158-294 , p < 0.001 ) .
RESULTS	We found no significant differences in quality of life .
RESULTS	The bootstrapped incremental cost-effectiveness ratios in the cost-effectiveness plane showed that the intervention was the efficient , cost-saving modality .
CONCLUSIONS	Our data show the benefits of tailoring diagnostic assessment to the screening radiologist 's suspicion of breast cancer .
CONCLUSIONS	Scenarios of implementing such a strategy in the Dutch screening or health care system are currently being discussed with various stakeholders .

###26072190
BACKGROUND	Although informed consent is vital to patient-physician communication , little training is provided to surgical trainees .
BACKGROUND	We hypothesized that highlighting critical aspects of informed consent would improve resident performance .
METHODS	Eighty ( out of 88 ) surgical postgraduate year 1 surgical residents were randomly assigned to one of the 2 cases ( laparoscopic cholecystectomy or ventral herniorrhaphy ) and instructed to obtain and document informed consent with a standardized patient ( SP ) followed by a didactic training session .
METHODS	The residents then obtained and documented informed consent with the other case with the other SP .
METHODS	SPs graded encounters ( `` Checklist '' ) ; trained raters graded notes .
METHODS	Repeated measures multivariate analysis of variance ( MANOVA ) was used to determine differences between pre - and post-training and Checklist versus `` Note '' scores .
RESULTS	Statistically significant pre - to post differences for Note ( P < .01 ) and Checklist ( P < .01 ) along with significant differences between Note and Checklist ( P < .01 ) were noted .
CONCLUSIONS	Training improved surgery residents ' ability to discuss and document informed consent .
CONCLUSIONS	Despite this improvement , significant differences between discussion and documentation persisted .
CONCLUSIONS	Documentation training is a future area for improvement .

###25089513
BACKGROUND	Studies show high comorbidity between anxiety disorder and depression .
BACKGROUND	Little is known regarding how anxiety symptoms affect prognosis in depression treatment , suggesting the importance of studying the impact of anxiety symptoms in the treatment of depression .
BACKGROUND	We evaluated the impact of anxiety symptoms in the remission of depressive symptoms after brief psychotherapies for depression .
METHODS	This randomized clinical trial of 18-29-year-old adults included individuals who met the diagnostic criteria for depression as assessed by the Structured Clinical Interview for DSM ( SCID ) .
METHODS	Depressive symptoms were assessed using the Hamilton Rating Scale for Depression ( HRSD ) ; anxiety symptoms were assessed using the Hamilton Anxiety Rating Scale ( HARS ) .
METHODS	The protocols of psychotherapy used were : Cognitive Narrative Psychotherapy ( CNP ) and Cognitive Behavioral Psychotherapy ( CBP ) .
METHODS	Both treatments included seven sessions .
METHODS	At the end of the treatment and six-month follow-up , an evaluation was made with the HRSD and HARS .
METHODS	The sample included 97 patients divided between the protocols of psychotherapy .
RESULTS	There was a significant , positive , moderate correlation between the severity of anxiety symptoms at baseline and the remission of depressive symptoms at post-intervention ( r = 0.38 p < 0.001 ) as well as a significant , positive , low correlation at follow up ( r = 0.20 p = 0.049 ) .
RESULTS	We found remission of anxiety symptoms and depressive symptoms after brief psychotherapies , and the remission persisted at follow up .
CONCLUSIONS	We did not evaluate the diagnosis of anxiety disorders .
CONCLUSIONS	The severity of anxiety symptoms did not compromise the treatment focused primarily on depressive symptoms .

###24972632
BACKGROUND	Inadequate energy and micronutrient intake during childhood is a major public health problem in developing countries .
BACKGROUND	Ready-to-use supplementary food ( RUSF ) made of locally available food ingredients can improve micronutrient status and growth of children .
BACKGROUND	The objective of this study was to develop RUSF using locally available food ingredients and test their acceptability .
METHODS	A checklist was prepared of food ingredients available and commonly consumed in Bangladesh that have the potential of being used for preparing RUSF .
METHODS	Linear programming was used to determine possible combinations of ingredients and micronutrient premix .
METHODS	To test the acceptability of the RUSF compared to Pushti packet ( a cereal based food-supplement ) in terms of amount taken by children , a clinical trial was conducted among 90 children aged 6-18 months in a slum of Dhaka city .
METHODS	The mothers were also asked to rate the color , flavor , mouth-feel , and overall liking of the RUSF by using a 7-point Hedonic Scale ( 1 = dislike extremely , 7 = like extremely ) .
RESULTS	Two RUSFs were developed , one based on rice-lentil and the other on chickpea .
RESULTS	The total energy obtained from 50 g of rice-lentil , chickpea-based RUSF and Pushti packet were 264 , 267 and 188 kcal respectively .
RESULTS	Children were offered 50 g of RUSF and they consumed ( meanSD ) 23.814 g rice-lentil RUSF , 28.415 g chickpea based RUSF .
RESULTS	Pushti packet was also offered 50 g but mothers were allowed to add water , and children consumed 17.114 g. Mean feeding time for two RUSFs and Pushti packet was 20.9 minutes .
RESULTS	Although the two RUSFs did not differ in the amount consumed , there was a significant difference in consumption between chickpea-based RUSF and Pushti packet ( p = 0.012 ) .
RESULTS	Using the Hedonic Scale the two RUSFs were more liked by mothers compared to Pushti packet .
CONCLUSIONS	Recipes of RUSF were developed using locally available food ingredients .
CONCLUSIONS	The study results suggest that rice-lentil and chickpea-based RUSF are well accepted by children .
BACKGROUND	ClinicalTrials.gov NCT01553877 .
BACKGROUND	Registered 24 January 2012 .

###24255993
OBJECTIVE	To compare the clinical and microbiological outcome of the 1-h ultrasonic debridement of chronic periodontitis patients ( CPP ) with and without frequent sessions of oral hygiene reinforcement .
METHODS	Clinical measurements and subgingival plaque were collected from 44 CPP at baseline , 3 - and 6-months .
METHODS	The control group received a single session of 1-h full-mouth ultrasonic debridement , while oral hygiene instructions ( OHI ) were reiterated over four visits .
METHODS	In the test group , OHI were limited in the 1-h treatment session .
METHODS	At 3-months , both groups received additional debridement and OHI .
METHODS	The `` Checkerboard '' DNA-DNA hybridization technique quantified Porphyromonas gingivalis , Tannerella forsythia and Treponema denticola in plaque .
RESULTS	At threemonths , smaller reductions in plaque and bleeding indices , and in P. gingivalis numbers were noted in the test group , while these differences disappeared at sixmonths .
RESULTS	After the 3-month re-treatment visit , the test group presented with a greater probing pocket depth ( PPD ) reduction .
RESULTS	Plaque negatively affected PPD in a similar manner after both treatment approaches .
CONCLUSIONS	Lack of oral hygiene reinforcement in the 1-h full-mouth debridement resulted in higher plaque and bleeding scores and numbers of P. gingivalis at threemonths ; professional removal of dental biofilm every threemonths is beneficial in subjects with compromised plaque control .

###24698135
OBJECTIVE	Initiating and maintaining physical activity presents the individual with challenges of inconvenience , discomfort , and counteractive energy .
OBJECTIVE	Addressing these challenges requires an intervention that elicits motivation to engage in this activity , minimizes the direct relationship between unwanted internal experiences and inaction , and is also in itself accessible and convenient .
OBJECTIVE	Accordingly , this study investigated the efficacy of a self-managed Acceptance and Commitment Therapy ( ACT ) intervention delivered via DVD and tailored for physical activity initiation .
METHODS	Fifty-nine minimally active community participants were randomly allocated to receive a 12-week pedometer-based walking programme , or the same walking programme with the additional provision of the ACT DVD .
METHODS	The primary outcome was overall physical activity level ( assessed at baseline and post-intervention ) , and the secondary outcome was pedometer-assessed step count ( measured at 4-weekly intervals throughout the intervention period ) .
RESULTS	Participants who received the ACT DVD achieved a significantly greater increase in physical activity levels post-intervention , were more likely to achieve the goals specified in the programme , and reported a higher average step count than participants who received the walking programme in isolation .
CONCLUSIONS	The ACT intervention , delivered via DVD for the promotion of physical activity , proved a simple , efficient , and accessible method to encourage positive short-term increases in an important health-promoting behaviour .
CONCLUSIONS	Statement of contribution What is already known ?
CONCLUSIONS	ACT interventions can increase physical activity levels through augmenting initiatory self-regulatory control .
CONCLUSIONS	Face-to-face delivery presents challenges of accessibility and feasibility for community implementation .
CONCLUSIONS	There is a need for effective interventions that maximize impact while minimizing inconvenience .
CONCLUSIONS	What does this study add ?
CONCLUSIONS	Supplementing a walking programme with a self-managed ACT DVD produced significant increases in physical activity .
CONCLUSIONS	The ACT DVD is a convenient , accessible , and potentially cost-effective approach to physical activity initiation .
CONCLUSIONS	ACT lends itself to implementation as a self-managed electronically delivered intervention .

###25633893
OBJECTIVE	The biocompatibility of dialyzers may influence the inflammatory state of hemodialysis patients .
OBJECTIVE	This study compares the effect of a high-flux polynephron membrane with other high-flux membranes , helixone and polyamide , on some inflammation biomarkers based on the analysis of circulating mononuclear cells ( MC ) .
METHODS	The study included 47 patients on hemodialysis with helixone and polyamide ; 9 formed the control group , without changes in their dialyzers throughout the study , and 38 formed the intervention group , in which their dialyzers were replaced by polynephron .
METHODS	In both groups , blood samples were taken at the beginning of the study before and after hemodialysis session , and at the end of the study 4 months later .
METHODS	In each extraction , biochemical parameters were determined , and MC isolated using Ficoll gradient .
METHODS	Production of reactive oxygen species and the percentage of activated MC ( CD14 + CD16 + ) were measured by flow cytometry , and protein levels of heat-shock proteins ( Hsp70/Hsp90 ) studied by Western blot .
RESULTS	After 1 hemodialysis session with different membranes , no significant differences were observed in the different parameters considered .
RESULTS	After 4 months of dialysis with polynephron , a significant reduction in the percentage of CD14 + CD16 + and in the 2-microglobulin reduction ratio were found , with respect to helixone and polyamide , without changes in the other parameters analyzed .
CONCLUSIONS	The use of polynephron for 4 months reduces the percentage of CD14 + CD16 + compared to helixone and polyamide , suggesting a better profile regarding activation of the inflammatory response .
CONCLUSIONS	These findings could be explained by a better biocompatibility or an increased reduction of medium-sized toxic molecules .

###24463421
BACKGROUND	Injuries at home are a major cause of death , disability , and loss of quality of life among young children .
BACKGROUND	Despite current safety education , required safety behavior of parents is often lacking .
BACKGROUND	To prevent various childhood disorders , the application of Web-based tools has increased the effectiveness of health promotion efforts .
BACKGROUND	Therefore , an intervention with Web-based , tailored , safety advice combined with personal counseling ( E-Health4Uth home safety ) was developed and applied .
OBJECTIVE	To evaluate the effect of E-Health4Uth home safety on parents ' safety behaviors with regard to the prevention of falls , poisoning , drowning , and burns .
METHODS	A randomized controlled trial was conducted ( 2009-2011 ) among parents visiting well-baby clinics in the Netherlands .
METHODS	Parents were randomly assigned to the intervention group ( E-Health4Uth home safety intervention ) or to the control condition consisting of usual care .
METHODS	Parents in the intervention condition completed a Web-based safety behavior assessment questionnaire ; the resulting tailored safety advice was discussed with their child health care professional at a well-baby visit ( age approximately 11 months ) .
METHODS	Parents in the control condition received counseling using generic safety information leaflets at this well-baby visit .
METHODS	Parents ' child safety behaviors were derived from self-report questionnaires at baseline ( age 7 months ) and at follow-up ( age 17 months ) .
METHODS	Each specific safety behavior was classified as safe/unsafe and a total risk score was calculated .
METHODS	Logistic and linear regression analyses were used to reveal differences in safety behavior between the intervention and the control condition at follow-up .
RESULTS	A total of 1292 parents ( response rate 44.79 % ) were analyzed .
RESULTS	At follow-up , parents in the intervention condition ( n = 643 ) showed significantly less unsafe behavior compared to parents in the control condition ( n = 649 ) : top of staircase ( 23.91 % vs. 32.19 % ; OR 0.65 , 95 % CI 0.50-0 .85 ) ; bottom of staircase ( 63.53 % vs. 71.94 % ; OR 0.69 , 95 % CI 0.53-0 .88 ) ; top and bottom of staircase ( 68.94 % vs. 78.28 % ; OR 0.62 , 95 % CI 0.48-0 .81 ) ; storage of cleaning products ( 30.33 % vs. 39.91 % ; OR 0.67 , 95 % CI 0.53-0 .85 ) ; bathing of the child ( 23.46 % vs. 32.25 % ; OR 0.65 , 95 % CI 0.51-0 .84 ) ; drinking hot fluids ( 34.84 % vs. 41.73 % ; OR 0.76 , 95 % CI 0.61-0 .96 ) ; using rear hotplates ( 79.34 % vs. 85.27 % ; OR 0.67 , 95 % CI 0.50-0 .90 ) ; and the total risk score in which a higher score indicates more unsafe behavior ( mean 13.63 , SD 6.12 vs. mean 15.34 , SD 6.07 ; beta -1.59 , 95 % CI -2.26 to -0.93 ) .
RESULTS	There were no significant differences for other specific behaviors between the two study conditions .
CONCLUSIONS	Compared to generic written materials , the E-Health4Uth home safety intervention seems more effective in promoting parents ' safety behavior for safe staircases , storage of cleaning products , bathing , drinking hot fluids , and cooking .
CONCLUSIONS	This study supports the application of Web-based , tailored , safety advice for the prevention of unintentional injuries in the youth health care setting .
BACKGROUND	Nederlands Trial Register : NTR1836 ; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1836 ( Archived by WebCite at http://www.webcitation.org/6MPIGQxpx ) .

###25778333
OBJECTIVE	The main objective of this study was to compare the effect of two anaesthetic techniques ( general vs combined ) on plasma levels of NGAL ( Neutrophil Gelatinase Associated Lipocalin ) after robotic urogenital oncosurgery .
OBJECTIVE	The secondary objective was to correlate NGAL levels with the incidence of acute kidney injury ( AKI ) .
METHODS	This was a longitudinal prospective study .
METHODS	Forty patients were included and randomized in 2 groups : group C ( N = 16 cases ; combined general-epidural anesthesia ) and group G ( N = 24 cases ; control group with general anesthesia ) .
METHODS	Demographic data , Charlson Comorbidity Index , Apache II , SOFA and ASA scores were similar in both groups .
METHODS	Serum creatinine was determined preoperatively and every 24 hrs for 4 postoperative days to identify AKI according to RIFLE and AKIN criteria .
METHODS	Serum NGAL was determined at 6 and 12 hrs after induction of anesthesia .
RESULTS	Serum creatinine increased at 24 hrs postoperatively in both groups as compared to baseline , but significant changes were registered only in the G group ( p ( control ) = 0.004 ) .
RESULTS	Serum NGAL increased significantly in both groups as compared with baseline levels ( pcase = 0.0034 vs p ( control ) = 0.0001 ) .
RESULTS	The incidence of AKI was 12.50 % ( 95 % CI 0.4-34 ) in the C group and 37.50 % ( 95 % CI 17-58 ) in the G group ( p = 0.0909 ) , respectively .
CONCLUSIONS	Impaired renal function and AKI occurred in robot-assisted laparoscopic urogenital oncosurgery under both general and combined anaesthesia .
CONCLUSIONS	The incidence of AKI was lower in patients undergoing combined anesthesia compared to general anaesthesia after robotic urogenital oncosurgery but the difference did not reach statistical significance .
CONCLUSIONS	However , plasma levels of NGAL were significantly increased at 6 and 12 hrs in the general anaesthesia group as compared with combined anaesthesia .
CONCLUSIONS	NGAL may be a better marker in detecting postoperative acute kidney injury .
CONCLUSIONS	Further studies are needed .

###24880000
BACKGROUND	Concerns about pain medications are major barriers to pain management in hospice , but few studies have focused on systematic methods to address these concerns .
OBJECTIVE	The objective of this study was to test the preliminary efficacy of the Effective Management of Pain : Overcoming Worries to Enable Relief ( EMPOWER ) intervention , which included hospice staff education , staff screening of barriers to pain management at admission , and discussion about misunderstandings regarding pain management with family caregivers and patients .
METHODS	We conducted a pilot , cluster randomized , controlled trial with four hospices .
METHODS	One hundred twenty-six family caregivers ( 55 interventions and 71 controls ) were interviewed at two weeks after admission .
METHODS	If patients survived three months after admission , caregivers were reinterviewed .
RESULTS	At two weeks , caregivers in the intervention group reported better knowledge about pain management ( P = 0.001 ) , fewer concerns about pain and pain medications ( P = 0.008 ) , and lower patient pain over the past week ( P = 0.014 ) and trended toward improvement in most other areas under study .
RESULTS	Exploratory analyses suggest that EMPOWER had a greater effect for black subjects ( vs. whites ) on reducing concern about stigma .
RESULTS	At three months , the intervention group trended better on most study outcomes .
CONCLUSIONS	EMPOWER is a promising model to reduce barriers to pain management in hospice .

###24750839
OBJECTIVE	To study the clinical efficacy of adjuvant therapy with glucocorticoids in children with lobar pneumonia caused by Mycoplasma pneumoniae .
METHODS	One hundred and eight children with lobar pneumonia caused by Mycoplasma pneumoniae were randomly divided into routine treatment and hormone treatment groups .
METHODS	Both groups were treated with azithromycin and other symptomatic therapies .
METHODS	In addition to the basic treatment , the hormone treatment group was given dexamethasone 0.25-0 .3 mg / ( kgd ) by intravenous drip until the body temperature was normal .
METHODS	Then given oral prednisone tablets 0.5-1 mg / ( kgd ) ( gradually reduced ) for a total treatment course of 7-10 days .
METHODS	Before and after treatment pulmonary functions were examined , and serum C-reactive protein ( CRP ) , erythrocyte sedimentation rate ( ESR ) , interleukin-2 ( IL-2 ) and interleukin-6 ( IL-6 ) were measured .
RESULTS	The duration of fever , cough relief time and pulmonary shadow absorption time on chest X-ray were significantly shorter in the hormone treatment group than in the routine treatment group ( P < 0.05 ) .
RESULTS	After treatment , the two groups showed improvements in serum CRP , ESR , IL-2 , and IL-6 ( P < 0.05 ) , but the hormone treatment group showed significantly more improvement ( P < 0.05 ) .
RESULTS	Varying degrees of mixed ventilation dysfunction were seen in the two groups before treatment , and hormone therapy significantly improved pulmonary function , especially promoting the recovery of small airway function .
CONCLUSIONS	Adjuvant therapy with glucocorticoids can effectively alleviate clinical symptoms , promote the absorption of pulmonary inflammation , and improve pulmonary function in children with lobar pneumonia caused by Mycoplasma pneumoniae .

###25233383
BACKGROUND	We sought to identify risk factors for mechanical ventilation in patients with malignancies and acute respiratory failure ( ARF ) .
METHODS	We analyzed data from a previous randomized controlled trial in which nonintubated oncology and hematology subjects with ARF were randomized to early bronchoalveolar lavage or routine care in 16 ICUs in France .
METHODS	Consecutive patients with malignancies were admitted to the ICU for ARF in 2005 and 2006 with no intervention .
RESULTS	During the study period , 219 patients were admitted to the ICU for ARF , and 8 patients were not included due to a nonintubation order .
RESULTS	Data on the underlying disease , pulmonary involvement , and extrapulmonary organ dysfunctions were recorded at admission in the 211 remaining subjects .
RESULTS	Ventilatory support included oxygen only ( 49 subjects ) , noninvasive ventilation ( NIV ) only ( 81 subjects ) , NIV followed by invasive mechanical ventilation ( 49 subjects ) , and first-line invasive mechanical ventilation ( 32 subjects ) .
RESULTS	The 81 subjects who required invasive mechanical ventilation were compared with the 130 subjects who remained on oxygen or NIV .
RESULTS	Factors associated with invasive mechanical ventilation by multivariate analysis were the oxygen flow required at ICU admission , the number of quadrants involved on chest x-ray , and hemodynamic dysfunction .
RESULTS	Mortality rates for subjects who had NIV failure were 65.3 % compared with 50 % for subjects who were first-line intubated ( P = .34 ) .
CONCLUSIONS	In cancer patients with ARF , hypoxemia , extent of pulmonary infiltration on chest x-ray , or hemodynamic dysfunction are risk factors for invasive mechanical ventilation .
CONCLUSIONS	Mortality was not significantly different between NIV failure and first-line intubation .

###24712573
BACKGROUND	Vitamin D deficiency , defined by the total serum 25-hydroxyvitamin D [ 25 ( OH ) D ] level , is common and more prevalent among Blacks than whites .
BACKGROUND	Vitamin D-binding protein ( DBP ) levels vary with race and may modulate `` bioavailable '' levels of 25 ( OH ) D.
OBJECTIVE	To determine the effect of DBP levels on the functional response to vitamin D.
METHODS	A randomized , placebo-controlled trial of vitamin D repletion for 2 mo , which took place at an outpatient research unit .
METHODS	Participants included 150 vitamin D-deficient ( 25 ( OH ) D < 20 ng/mL ) adults .
METHODS	Participants were randomly assigned to receive either 50,000 IU of vitamin D3 or placebo weekly for 8 weeks .
METHODS	This is a post-hoc analysis using DBP , 25 ( OH ) D , PTH , and calcium levels .
RESULTS	Blacks had lower total 25 ( OH ) D ( 12 vs 15 ng/mL , P < .001 ) and DBP levels ( 119 vs 234 g/mL , P < .001 ) than non-Blacks .
RESULTS	DBP levels were similar before and after vitamin D3 or placebo treatment ( r = 0.98 , P < .001 ) .
RESULTS	Baseline total 25 ( OH ) D levels were a significant determinant of baseline PTH levels ( P < .001 ) .
RESULTS	The change in total 25 ( OH ) D was associated with the change in PTH ( P < 0.001 ) and calcium levels ( P < .05 ) .
RESULTS	In contrast , DBP levels were not a determinant of baseline PTH ( P = .57 ) nor significantly related to changes in either PTH ( P = .53 ) or calcium levels ( P = .88 ) .
CONCLUSIONS	DBP levels are stable in Blacks and non-Blacks , and do not change with correction of vitamin D deficiency .
CONCLUSIONS	Even for individuals with total 25 ( OH ) D levels < 20 ng/mL , Blacks have significantly lower DBP levels than non-Blacks .
CONCLUSIONS	However , within this range of total 25 ( OH ) D , DBP levels do not influence the effect of vitamin D repletion on PTH or calcium levels .

###25475489
BACKGROUND	Heart failure ( HF ) significantly impacts on the daily lives of patients and their carers .
BACKGROUND	In Western society HF education programs have increased patient and carer knowledge and improved health-related quality of life .
BACKGROUND	However , there is a paucity of such evidence in Asia .
BACKGROUND	For example , to date no studies have been conducted in Thailand to investigate the potential benefits of a family-based education program on the health outcomes of HF patients and carers .
METHODS	This randomised controlled trial will evaluate the effectiveness of an education program on knowledge , self-care and health-related quality of life of Thai HF patients and their carers .
METHODS	Assessments will be conducted at baseline , three and six months .
METHODS	Participants will be assigned by independent random allocation to an intervention ( family-based education plus usual care ) or a control ( usual care ) group .
METHODS	Analyses will be conducted on an intention-to-treat basis .
CONCLUSIONS	This trial will be the first to evaluate the effectiveness of family-based education for HF patients and carers residing in rural Thailand .
CONCLUSIONS	It attempts to advance understanding of family-based HF education and address the gap in service provision .
BACKGROUND	Thai Clinical Trial Registry TCTR20140506003 .

###25751232
BACKGROUND	One-lung ventilation ( OLV ) can result in local and systemic inflammation .
BACKGROUND	This prospective , randomized trial was to evaluate the effect of therapeutic hypercapnia on lung injury after OLV .
METHODS	Fifty patients aged 20 to 60 yr undergoing lobectomy were randomly provided with air or carbon dioxide ( partial pressure of carbon dioxide : 35 to 45 mmHg or 60 to 70 mmHg ) .
METHODS	Peak pressure , plateau pressure , and lung compliance were recorded .
METHODS	Bronchoalveolar lavage fluid ( BALF ) and blood samples were collected .
METHODS	Adverse events were monitored .
METHODS	The primary outcome was the concentration of BALF tumor necrosis factor , and the secondary outcomes were serum cytokine concentrations .
RESULTS	The BALF tumor necrosis factor was lower in the carbon dioxide group than in the air group ( median [ range ] , 51.1 [ 42.8 to 76.6 ] vs. 71.2 [ 44.8 to 92.7 ] ; P = 0.034 ) .
RESULTS	Patients in the carbon dioxide group had lower concentrations of serum and BALF interleukin ( IL ) -1 , IL-6 , and IL-8 , but higher serum concentrations of IL-10 , accompanied by reduced numbers of cells and neutrophils as well as lower concentrations of protein in the BALF .
RESULTS	Also , patients in the carbon dioxide group had lower peak ( mean SD , 22.2 2.9 vs. 29.8 4.6 ) and plateau pressures ( 20.5 2.4 vs. 27.1 2.9 ) , but higher dynamic compliance ( 46.6 5.8 vs. 38.9 6.5 ) .
RESULTS	Furthermore , patients in the carbon dioxide group had higher postoperation oxygenation index values .
RESULTS	Ten patients experienced slightly increased blood pressure and heart rate during OLV in the carbon dioxide group .
CONCLUSIONS	Under intravenous anesthesia , therapeutic hypercapnia inhibits local and systematic inflammation and improves respiratory function after OLV in lobectomy patients without severe complications .

###25577502
OBJECTIVE	The purpose was to explore operable lung cancer patient experiences with an exercise intervention from a longitudinal perspective according to patient motivation and patient perceived benefits and barriers of exercise .
METHODS	Nineteen patients enrolled in an exercise intervention 2 weeks post-surgery participated in qualitative interviews at three time points .
METHODS	A criteria sampling strategy was applied .
METHODS	Ricoeur 's phenomenological hermeneutical philosophy inspired the analysis .
RESULTS	Patients initiated exercising median 15 days postoperative .
RESULTS	Eight patients included in the interview study dropped out of the intervention due to side effects of chemotherapy ( n = 3 ) and external circumstances ( n = 5 ) .
RESULTS	The mean attendance rate for the eleven participants who completed the intervention was 82 % .
RESULTS	No patients experienced severe adverse events .
RESULTS	Motivation for participation included patients ' expectations of physical benefits and the security of having professionals present .
RESULTS	Patients experienced physical and emotional benefits and affirmed their social identity .
RESULTS	Barriers were primarily related to side effects of chemotherapy .
CONCLUSIONS	The exercise intervention was undertaken safely by operable lung cancer patients initiated 2 weeks after surgery .
CONCLUSIONS	The intervention put the patients on track to a healthier lifestyle regarding physical activity and smoking .
CONCLUSIONS	The study indicates that exercise initiated early in the treatment trajectory is beneficial for operable lung cancer patients and especially for those who were physically active and motivated pre-illness and who did not experience side effect of treatment .

###26152298
OBJECTIVE	We developed a new postdischarge system of care comprising a structured assessment covering longer-term problems experienced by patients with stroke and their carers , linked to evidence-based treatment algorithms and reference guides ( the longer-term stroke care system of care ) to address the poor longer-term recovery experienced by many patients with stroke .
METHODS	A pragmatic , multicentre , cluster randomized controlled trial of this system of care .
METHODS	Eligible patients referred to community-based Stroke Care Coordinators were randomized to receive the new system of care or usual practice .
METHODS	The primary outcome was improved patient psychological well-being ( General Health Questionnaire-12 ) at 6 months ; secondary outcomes included functional outcomes for patients , carer outcomes , and cost-effectiveness .
METHODS	Follow-up was through self-completed postal questionnaires at 6 and 12 months .
RESULTS	Thirty-two stroke services were randomized ( 29 participated ) ; 800 patients ( 399 control ; 401 intervention ) and 208 carers ( 100 control ; 108 intervention ) were recruited .
RESULTS	In intention to treat analysis , the adjusted difference in patient General Health Questionnaire-12 mean scores at 6 months was -0.6 points ( 95 % confidence interval , -1.8 to 0.7 ; P = 0.394 ) indicating no evidence of statistically significant difference between the groups .
RESULTS	Costs of Stroke Care Coordinator inputs , total health and social care costs , and quality-adjusted life year gains at 6 months , 12 months , and over the year were similar between the groups .
CONCLUSIONS	This robust trial demonstrated no benefit in clinical or cost-effectiveness outcomes associated with the new system of care compared with usual Stroke Care Coordinator practice .
BACKGROUND	URL : http://www.controlled-trials.com .
BACKGROUND	Unique identifier : ISRCTN 67932305 .

###25142571
OBJECTIVE	To investigate the comparative efficacy of cognitive behavioral therapy ( CBT ) , Tai Chi Chih ( TCC ) , and sleep seminar education control ( SS ) on the primary outcome of insomnia diagnosis , and secondary outcomes of sleep quality , fatigue , depressive symptoms , and inflammation in older adults with insomnia .
METHODS	Randomized controlled , comparative efficacy trial .
METHODS	Los Angeles community .
METHODS	123 older adults with chronic and primary insomnia .
METHODS	Random assignment to CBT , TCC , or SS for 2-hour group sessions weekly over 4 months with follow-up at 7 and 16 months .
METHODS	Insomnia diagnosis , patient-reported outcomes , polysomnography ( PSG ) , and high-sensitivity C-reactive protein ( CRP ) levels .
RESULTS	CBT performed better than TCC and SS in remission of clinical insomnia as ascertained by a clinician ( P < 0.01 ) , and also showed greater and more sustained improvement in sleep quality , sleep parameters , fatigue , and depressive symptoms than TCC and SS ( all P values < 0.01 ) .
RESULTS	As compared to SS , CBT was associated with a reduced risk of high CRP levels ( > 3.0 mg/L ) at 16 months ( odds ratio [ OR ] , 0.26 [ 95 % CI , 0.07-0 .97 ] P < 0.05 ) .
RESULTS	Remission of insomnia was associated with lower levels of CRP ( P < 0.05 ) at 16 months .
RESULTS	TCC was associated with improvements in sleep quality , fatigue , and depressive symptoms as compared to SS ( all P 's < 0.05 ) , but not insomnia remission .
RESULTS	PSG measures did not change .
CONCLUSIONS	Treatment of late-life insomnia is better achieved and sustained by cognitive behavioral therapies .
CONCLUSIONS	Insomnia treatment and remission reduces a marker of inflammatory risk , which has implications for cardiovascular morbidity and diabetes observed with sleep disturbance in epidemiologic surveys .

###24290656
OBJECTIVE	The use of bone marrow mononuclear cells ( BM-MNCs ) has achieved great outcomes in clinical practice .
OBJECTIVE	We aim to evaluate the efficacy and safety of autologous BM-MNC infusion and hyperbaric oxygen therapy ( HOT ) in type 2diabetes mellitus .
METHODS	This single-center , randomized , open-label , controlled clinical trial with a factorial design included two phases .
METHODS	The patients received standard medical therapy in the run-in phase ; in the treatment phase , patients with glycated hemoglobin of 7.5-9 .5 % were randomly assigned into four groups and underwent BM-MNC infusion along with HOT ( BM-MNC + HOT group ) , BM-MNC infusion ( BM-MNC group ) , HOT ( HOT group ) and standard medical therapy ( control group ) , respectively .
METHODS	The area under the curve of C-peptide was recorded as a primary end point .
METHODS	Our research is registered at ClinicalTrials.gov ( NCT00767260 ) .
RESULTS	A total of 80 patients completed the follow-up .
RESULTS	At 12months after treatment , the area under the curve of C-peptide ( ng/mL per 180 min ) of the BM-MNC + HOT group and the BM-MNC group were significantly improved ( 34.0 % and 43.8 % from the baseline , respectively ) .
RESULTS	The changes were both significant compared with that in the control group , but no remarkable change was observed in the HOT group .
RESULTS	Treatment-related adverse events were mild , including transient abdominal pain ( n = 5 ) and punctual hemorrhage ( n = 3 ) .
CONCLUSIONS	BM-MNC infusion for type 2 diabetes mellitus improves islet function and metabolic control , with mild adverse effects .
CONCLUSIONS	HOT does not synergize with BM-MNC infusion .

###24491079
OBJECTIVE	Alcohol consumption in adolescence is associated with problem drinking in later life , and there is a need to develop evidence-based interventions to reduce adolescent alcohol consumption .
OBJECTIVE	The aims of the present study were to test the ability of a very brief intervention based on self-affirmation theory to reduce alcohol consumption in a sample of adolescents and to examine potential mediators of the effects .
METHODS	67 adolescents were randomly allocated either to form a self-affirming implementation intention or to complete a distractor task .
METHODS	All participants were exposed to a threatening message concerning the health risks of alcohol consumption .
METHODS	The main outcome measure was subsequent alcohol intake , but message processing ( operationalized as perceived threat and message derogation ) , behavioral intention , and self-efficacy were also measured as potential mediators .
RESULTS	The intervention produced a significant decrease in alcohol consumption : Participants in the self-affirming implementation intention condition consumed 2.48 fewer grams of pure alcohol per day at the end of the study than adolescents who completed the distractor task .
RESULTS	The effect was not mediated by perceived threat , message derogation , behavioral intention , or self-efficacy .
CONCLUSIONS	The findings provide support for the efficacy of the self-affirming implementation intention for promoting health behavior change and extend previous research by testing an adolescent sample and observing longer term effects .
CONCLUSIONS	Further research is needed to find out what mediates the effects of self-affirming implementation intentions on health behavior change .

###25612894
BACKGROUND	Impaired sexual function is increasingly recognized as a side effect of psychopharmacological treatment .
BACKGROUND	However , underlying mechanisms of action of the different drugs on sexual processing are still to be explored .
BACKGROUND	Using functional magnetic resonance imaging , we previously investigated effects of serotonergic ( paroxetine ) and dopaminergic ( bupropion ) antidepressants on sexual functioning ( Abler et al. , 2011 ) .
BACKGROUND	Here , we studied the impact of noradrenergic and antidopaminergic medication on neural correlates of visual sexual stimulation in a new sample of subjects .
METHODS	Nineteen healthy heterosexual males ( mean age 24 years , SD 3.1 ) under subchronic intake ( 7 days ) of the noradrenergic agent reboxetine ( 4 mg/d ) , the antidopaminergic agent amisulpride ( 200mg/d ) , and placebo were included and studied with functional magnetic resonance imaging within a randomized , double-blind , placebo-controlled , within-subjects design during an established erotic video-clip task .
METHODS	Subjective sexual functioning was assessed using the Massachusetts General Hospital-Sexual Functioning Questionnaire .
RESULTS	Relative to placebo , subjective sexual functioning was attenuated under reboxetine along with diminished neural activations within the caudate nucleus .
RESULTS	Altered neural activations correlated with decreased sexual interest .
RESULTS	Under amisulpride , neural activations and subjective sexual functioning remained unchanged .
CONCLUSIONS	In line with previous interpretations of the role of the caudate nucleus in the context of primary reward processing , attenuated caudate activation may reflect detrimental effects on motivational aspects of erotic stimulus processing under noradrenergic agents .

###25660281
OBJECTIVE	Several studies on lactobacilli have demonstrated they are effective against atopic dermatitis ( AD ) in children , but there are very few reports of their effects in adults .
OBJECTIVE	We investigated the changes in AD symptoms in adults after the ingestion of the Lactobacillus acidophilus strain L-92 ( L-92 ) , which has been shown to have a curative effect on AD in children .
METHODS	A double-blind , parallel-group , placebo-controlled comparison was performed on 49 AD patients aged 16 years using heat-killed L-92 .
METHODS	Skin lesions were assessed using the SCORing AD ( SCORAD ) index before the start of L-92 ingestion and 4 and 8 weeks after ingestion .
METHODS	Serum cytokine and blood marker levels were measured 8 weeks after the start of L-92 ingestion .
RESULTS	The group that ingested L-92 had lower SCORAD scores than the controls ( p = 0.002 ) .
RESULTS	The L-92 group also had decreased ratios of change for eosinophil count ( p = 0.03 ) and increased ratios of change for serum TGF - ( p = 0.03 ) .
RESULTS	Ratios of change for serum TGF - rose significantly ( p = 0.04 ) in patients showing mitigated symptoms with L-92 administration .
CONCLUSIONS	Administration of heat-killed L-92 was effective for AD symptoms in adults .
CONCLUSIONS	L-92 may contribute to the suppression of Th2-dominant inflammation .
CONCLUSIONS	Our preliminary trial is the first to report the effects of L-92 on adult AD .

###24990161
BACKGROUND	The incidence and severity of gastroesophageal reflux disease ( GERD ) in Japan tends to increase in elderly women .
BACKGROUND	Rikkunshito ( RKT ) , a traditional Japanese medicine , acts as a prokinetic agent and improves gastric emptying and gastric accommodation .
BACKGROUND	Our previous prospective randomized placebo-controlled study showed that RKT combined with a standard-dose of rabeprazole ( RPZ ) significantly improved the acid-related dysmotility symptoms ( ARD ) in elderly patients with proton pump inhibitor ( PPI ) - refractory non-erosive reflux disease ( NERD ) .
BACKGROUND	This study aimed to evaluate clinical characteristics of elderly PPI-refractory NERD patients with ARD symptoms who responded to RKT .
METHODS	Two hundred forty-two patients with PPI-refractory NERD were randomly assigned to 8 weeks of either RPZ ( 10 mg/q .
METHODS	d. ) + RKT ( 7.5 g/t .
METHODS	i.d. ) ( RKT group ) or RPZ + placebo ( PL group ) .
METHODS	Among them , 95 were elderly ( 65 years ) with ARD ( RKT group : n = 52 ; PL group : n = 43 ) .
METHODS	We analyzed the changes using the 12 subscale score of frequency scale for the symptoms of GERD ( FSSG ) and 15 items of the Gastrointestinal Symptom Rating Scale at 4 and 8 weeks and compared the therapeutic efficacy between the 2 groups .
RESULTS	There were no marked differences in baseline demographic or clinical characteristics in the 2 groups except for rate of current smoking .
RESULTS	The FSSG score ( mean SD at 0 , 4 , and 8 weeks ) in both the RKT ( 16.0 7.0 ; 9.9 8.4 ; 7.0 6.4 ) and PL ( 15.1 6.4 ; 10.9 6.7 , 11.1 8.5 ) groups significantly decreased after treatment .
RESULTS	However , the degree of improvement of total and ARD scores of FSSG after the 8-week treatment was significantly greater in the RKT group than in the PL group .
RESULTS	Combination therapy with RKT for 8 weeks showed significant improvement in 3 subscale scores ( abdominal bloating , heavy feeling in stomach and sick feeling after meals ) of the ARD domain and 1 subscale score ( heartburn after meals ) of the reflux symptom domain .
CONCLUSIONS	RKT may be useful for improving GERD symptoms in elderly PPI-refractory NERD patients with ARD .
CONCLUSIONS	Thus , RKT was particularly effective for resolving postprandial GERD symptoms ( heavy feeling in stomach , sick feeling , and heartburn after meals ) .
BACKGROUND	( UMIN000005880 ) .

###25014996
BACKGROUND	Acute exacerbation of chronic obstructive pulmonary disease ( AECOPD ) is a common cause of morbidity and mortality .
BACKGROUND	Traditional Chinese medicine ( TCM ) is used to treat AECOPD as adjunctive therapy .
BACKGROUND	This study aimed to evaluate the efficacy and safety of the TCM formula Xuan Bai Cheng Qi as an adjuvant therapy for AECOPD patients with the syndrome type of phlegm-heat obstructing the lungs .
METHODS	A multicenter , randomized , double-blind , placebo-controlled clinical trial was conducted .
METHODS	A total of 244 patients were divided into the intervention group ( n = 122 , treated with conventional medicine and Xuan Bai Cheng Qi ) and the control group ( n = 122 , treated with conventional medicine and placebo ) .
METHODS	Total symptom scores ( cough , phlegm , wheezing , chest congestion ) before treatment and at 3 , 5 , 7 , 10 days post-treatment were recorded .
METHODS	Lung function , arterial blood gas , serum inflammatory cytokines , oxidation/anti-oxidation index were observed before treatment and at the end of the 10-day treatment .
RESULTS	A total of 242 patients completed the study .
RESULTS	The full analysis set ( FAS ) population was 244 and the per-protocol analysis set ( PPS ) population was 229 .
RESULTS	After the 10-day treatment , symptom scores of the Xuan Bai Cheng Qi group were significantly lower over time compared with the control group ( FAS : mean difference -1.84 , 95 % CI -2.66 to -1.03 , P < .001 ; PPS : mean difference -1.87 , 95 % CI -2.71 to -1.03 , P < .001 ) .
RESULTS	FEV1 , FVC , and FEV1 % pred were significantly higher over time in the Xuan Bai Cheng Qi group compared with those in the control group ( day 10 , FAS and PPS : P < .05 ) .
RESULTS	PaO2 and PaCO2 were significantly improved in the Xuan Bai Cheng Qi group ( day 10 , FAS and PPS : P < .05 ) .
RESULTS	Xuan Bai Cheng Qi was also found to ameliorate cytokine levels and oxidation/antioxidant index compared with placebo .
RESULTS	There were no differences in safety variables and adverse events between the two groups .
CONCLUSIONS	Xuan Bai Cheng Qi formula appears to be a safe and beneficial treatment for AECOPD of phlegm-heat obstructing the lungs syndrome type .

###25263261
BACKGROUND	Both contingency management ( CM ) and exercise have shown promise as smoking cessation treatments , but their combined effects have not been evaluated .
BACKGROUND	The present study evaluated whether CM ( in which motivational incentives are provided for abstinence ) plus exercise reduced smoking more than either component alone .
METHODS	In a within-subjects design , 20 smokers were exposed to exercise plus CM , exercise plus CM-control ( non-contingent incentives ) , inactivity plus CM , and inactivity plus CM-control .
RESULTS	CM increased latencies to smoke and decreased total puffs ( Mdns = 39.6 min and .8 puffs , respectively ) relative to CM-control ( Mdns = 2.5 min and 12.8 puffs ) .
RESULTS	Exercise decreased craving relative to baseline for craving based on both the pleasurable consequences of smoking ( D = -10.7 on a 100-point visual analog scale ) and anticipated relief from withdrawal ( D = -5.9 ) , whereas inactivity increased both components of craving ( Ds = 7.6 and 3.5 ) .
RESULTS	Exercise had no effect on smoking or a measure of temporal discounting .
CONCLUSIONS	Although exercise decreased craving , it did not affect smoking behavior .
CONCLUSIONS	Exercise plus CM was not more effective than CM alone .

###24469475
BACKGROUND	The diagnosis of varicocle is clinical .
BACKGROUND	In order to improve diagnosis of varicocele , we compared the clinical with the ultrasound findings in schoolboys with the condition .
BACKGROUND	This is because the conditions can affect testicular growth .
METHODS	It was a cross-sectional , descriptive study of schoolboys aged from 10 to 19 years who had varicocele .
METHODS	Among 2724 boys examined , 149 had varicocele and only 81 had scrotal ( 18 with Doppler ) and renal ultrasound examination .
RESULTS	Among the 81 adolescents who were clinically diagnosed with varicocele and also with the aid of ultrasound scan , 25 , 36 and 20 had grade 1 , 2 and 3 , respectively .
RESULTS	Testicular hypotrophy ( TH ) was clinically noticed in 17 cases .
RESULTS	At ultrasonography , varicocele was bilateral in 87.66 % and unilateral in 12.34 % ( P = 0.01 ) with 32 adolescents ( 39.51 % ) showing TH compared with 20.99 % being diagnosed with TH using clinical examination alone ( P = 0.01 ) .
RESULTS	In 50 schoolboys ( 61.73 % ) with unilateral varicocele , a subclinical type was discovered at other side .
RESULTS	Renal ultrasound revealed abnormalities in 4.93 % of cases .
RESULTS	Doppler ultrasound helped in finding varicoceles along the top edge of the testis ( n = 15 ) and under tunica albuginea ( n = 3 ) .
CONCLUSIONS	TH due to varicocele is better studied by ultrasound .

###24852952
OBJECTIVE	To evaluate the psychological consequences among family members given the option to be present during the CPR of a relative , compared with those not routinely offered the option .
METHODS	Prospective , cluster-randomized , controlled trial involving 15 prehospital emergency medical services units in France , comparing systematic offer for a relative to witness CPR with the traditional practice among 570 family members .
METHODS	Main outcome measure was 1-year assessment included proportion suffering post-traumatic stress disorder ( PTSD ) , anxiety and depression symptoms , and/or complicated grief .
RESULTS	Among the 570 family members [ intention to treat ( ITT ) population ] , 408 ( 72 % ) were evaluated at 1 year .
RESULTS	In the ITT population ( N = 570 ) , family members had PTSD-related symptoms significantly more frequently in the control group than in the intervention group [ adjusted odds ratio , 1.8 ; 95 % confidence interval ( CI ) 1.1-3 .0 ; P = 0.02 ] as did family members to whom physicians did not propose witnessing CPR [ adjusted odds ratio , 1.7 ; 95 % CI 1.1-2 .6 ; P = 0.02 ] .
RESULTS	In the observed cases population ( N = 408 ) , the proportion of family members experiencing a major depressive episode was significantly higher in the control group ( 31 vs. 23 % ; P = 0.02 ) and among family members to whom physicians did not propose the opportunity to witness CPR ( 31 vs. 24 % ; P = 0.03 ) .
RESULTS	The presence of complicated grief was significantly greater in the control group ( 36 vs. 21 % ; P = 0.005 ) and among family members to whom physicians did not propose the opportunity to witness resuscitation ( 37 vs. 23 % ; P = 0.003 ) .
CONCLUSIONS	At 1 year after the event , psychological benefits persist for those family members offered the possibility to witness the CPR of a relative in cardiac arrest .

###24708640
BACKGROUND	During leisure activities young people are often exposed to excessive noise levels resulting in an increase of noise-induced symptoms such as hearing loss , tinnitus and hyperacusis .
BACKGROUND	Noise-induced tinnitus is often perceived after loud music exposure and provides an important marker for overexposure as a temporary threshold shift that is often not experienced by the individual itself .
BACKGROUND	As oxidative stress plays an important role in the pathogenesis of noise-induced hearing loss , the use of antioxidants to prevent hearing damage has recently become the subject of research .
METHODS	This study proposes a randomized , double-blind , placebo-controlled crossover trial to assess the effects of a prophylactic combination of N-acetylcysteine ( 600 mg ) and magnesium ( 200 mg ) prior to leisure noise exposure in young adults .
METHODS	The primary outcome measure is the tinnitus loudness scored by a visual analogue scale ( VAS ) .
METHODS	Secondary outcome measures are the differences in audiological measurements for the antioxidant treatments compared to placebo intake .
METHODS	Audiological testing comprising of pure tone audiometry including frequencies up to 16 kHz , distortion product otoacoustic emissions , transient-evoked otoacoustic emissions and speech-in-noise testing will be performed prior to and within 7 hours after noise exposure .
METHODS	By use of a mixed effects statistical model , the effects of antioxidants compared to placebo intake will be assessed .
CONCLUSIONS	As adolescents and young adults often do not use hearing protection while being exposed to loud music , the use of preventive antioxidant intake may provide a useful and harmless way to prevent noise-induced hearing damage in this population .
CONCLUSIONS	Furthermore , when exposed to hazardous noise levels the protection provided by hearing protectors might not be sufficient to prevent hearing damage and antioxidants may provide additive otoprotective effects .
CONCLUSIONS	Previous research mainly focused on occupational noise exposure .
CONCLUSIONS	The present study provides a protocol to assess the usefulness of antioxidants during leisure noise activities .
BACKGROUND	The present protocol is registered at ClinicalTrials.gov : NCT01727492 .

###24962185
BACKGROUND	The open abdominal ( OA ) approach is a management strategy used in the most severely injured trauma patients .
BACKGROUND	In addition to the morbidity and mortality , a major challenge is the gradual development of dense adhesions that make reoperations progressively more difficult .
BACKGROUND	This randomized , prospective , proof-of-concept study was conducted to determine the effect of carboxymethylcellulose sodium hyaluronate adhesion barrier ( CMHAB ; Seprafilm , Genzyme Biosurgery , Bridgewater , NJ ) on abdominal adhesions and wound characteristics in trauma open abdomens .
METHODS	A prospective , randomized , controlled study of wound and adhesion characteristics with or without CMHAB was conducted at 5 level I trauma centers .
METHODS	Consenting patients were randomized to either CMHAB or no adhesion barrier ( NAB ) groups .
METHODS	We evaluated patient demographics , injury characteristics/severity , reason for OA management , wound sizes ( transverse/longitudinal ) , Zuhlke adhesion score , abdominal contamination score , hospital/intensive care durations of stay , morbidity , and mortality .
RESULTS	Thirty patients were enrolled ( 17 randomized to CMHAB ; 13 randomized to NAB ) with mean age of 40.3 , Injury Severity Score of 30 , Abbreviated Injury Score ( AIS ) - abdomen of 3.68 , APACHE II score of 14.4 , and 67 % blunt trauma mechanism .
RESULTS	The groups were well-matched with regard to age , sex , Injury Severity Score/abdominal AIS , penetrating/blunt injury rates , initial lactate/base deficit , mortality , OA indications , and contamination scores .
RESULTS	There were no differences in nonabdominal or abdominal complications ( ie , fistula , abscess , wound related ) between the groups .
RESULTS	Patients with CMHAB had shorter intensive care unit durations of stay ( 15 vs 22 days ; P < .05 ) .
RESULTS	Intraoperative adhesion scores were not different during the first four operations but diverged significantly at the 5th operative intervention or after about 1 week of OA therapy .
RESULTS	After the 5th operation , adhesion scores in the NAB group were 67 % greater ( approximately 1 Zuhlke point ) than the CMHAB group .
RESULTS	We did not note differences between wound sizes over time , closure types , or wound closure characteristics between CMHAB and NAB .
CONCLUSIONS	Although CMHAB did not eliminate adhesions in this proof-of-concept study , it limited their severity , particularly in abdomens left open > 9 days or requiring 5 operations .
CONCLUSIONS	There was no difference in wound sizes , overall or abdominal complications , or mortality between the groups .
CONCLUSIONS	Further research is warranted to better delineate potential benefits of CMHAB , especially in the setting of reoperations in post-OA patients .

###24925492
OBJECTIVE	The large contribution of inexperience to the high crash rate of newly licensed teens suggests that they enter licensure with insufficient skills .
OBJECTIVE	In a prior analysis , we found moderate support for a direct effect of a web-based intervention , the TeenDrivingPlan ( TDP ) , on teens ' driving performance .
OBJECTIVE	The purpose of the present study was to identify the mechanisms by which TDP may be effective and to extend our understanding of how teens learn to drive .
METHODS	A randomized controlled trial conducted with teen permit holders and parent supervisors ( N = 151 dyads ) was used to determine if the effect of TDP on driver performance operated through five hypothesized mediators : ( 1 ) parent-perceived social support ; ( 2 ) teen-perceived social support ; ( 3 ) parent engagement ; ( 4 ) practice quantity ; and ( 5 ) practice diversity .
METHODS	Certified driving evaluators , blinded to teens ' treatment allocation , assessed teens ' driving performance 24weeks after enrollment .
METHODS	Mediator variables were assessed on self-report surveys administered periodically over the study period .
RESULTS	Exposure to TDP increased teen-perceived social support , parent engagement , and practice diversity .
RESULTS	Both greater practice quantity and diversity were associated with better driving performance , but only practice diversity mediated the relationship between TDP and driver performance .
CONCLUSIONS	Practice diversity is feasible to change and increases teens ' likelihood of completing arigorous on-road driving assessment just before licensure .
CONCLUSIONS	Future research should continue to identify mechanisms that diversify practice driving , explore complementary ways to help families optimize the time they spend on practice driving , and evaluate the long-term effectiveness of TDP .

###24485633
OBJECTIVE	The role of low-dose dopamine infusion in patients with acute decompensated heart failure ( ADHF ) remains controversial .
OBJECTIVE	We aim to evaluate the efficacy and safety of high - versus low-dose furosemide with or without low-dose dopamine infusion in this patient population .
RESULTS	161 ADHF patients ( 78 years ; 46 % female ; ejection fraction 31 % ) were randomized to 8-hour continuous infusions of : a ) high-dose furosemide ( HDF , n = 50 , 20mg/h ) , b ) low-dose furosemide and low-dose dopamine ( LDFD , n = 56 , 5mg/h and 5 g kg ( -1 ) min ( -1 ) respectively ) , or c ) low-dose furosemide ( LDF , n = 55 , furosemide 5mg/h ) .
RESULTS	The main outcomes were 60-day and one-year all-cause mortality ( ACM ) and hospitalization for HF ( HHF ) .
RESULTS	Dyspnea relief ( Borg index ) , worsening renal function ( WRF , rise in serum creatinine ( sCr ) 0.3 mg/dL ) , and length of stay ( LOS ) were also assessed .
RESULTS	The urinary output at 2 , 4 , 6 , 8 , and 24h was not significantly different in the three groups .
RESULTS	Neither the ACM at day 60 ( 4.0 % , 7.1 % , and 7.2 % ; P = 0.74 ) or at one year ( 38.1 % , 33.9 % and 32.7 % , P = 0.84 ) nor the HHF at day 60 ( 22.0 % , 21.4 % , and 14.5 % , P = 0.55 ) or one year ( 60.0 % , 50.0 % , and 47 % , P = 0.40 ) differed between HDF , LDFD , and LDF groups , respectively .
RESULTS	No differences in the Borg index or LOS were noted .
RESULTS	WRF was higher in the HDF than in LDFD and LDF groups at day 1 ( 24 % vs. 11 % vs. 7 % , P < 0.0001 ) but not at sCr peak ( 44 % vs. 38 % vs. 29 % , P = 0.27 ) .
RESULTS	No significant differences in adverse events were noted .
CONCLUSIONS	In ADHF patients , there were no significant differences in the in-hospital and post-discharge outcomes between high - vs. low-dose furosemide infusion ; the addition of low-dose dopamine infusion was not associated with any beneficial effects .

###24678064
BACKGROUND	Adequate surgical field visualization is among the most important factors in preventing complications in functional endoscopic sinus surgery ( FESS ) .
BACKGROUND	The aim of this study was to assess the effect of topical cocaine vs adrenaline on surgical field visualization and intraoperative bleeding during FESS .
METHODS	A randomized controlled trial was conducted .
METHODS	A total of 37 patients that underwent FESS for chronic rhinosinusitis were randomized to the side of the nose that received adrenaline or cocaine-soaked patties , and the side that was operated first .
METHODS	The surgeon evaluating the bleeding was blinded to the vasoconstrictor allocation .
METHODS	At the commencement of surgery and at regular 15-minute intervals , the operating surgeon evaluated the extent of bleeding in the operative field according to a validated scale .
METHODS	At each assessment , mean arterial pressure ( MAP ) , heart rate , and end tidal CO2 were also recorded .
METHODS	At the end of each side , total blood loss was measured .
RESULTS	There was no difference in the mean surgical field scores between the adrenaline and cocaine sides ( 2.04 0.75 vs 2.17 0.7 , p = 0.24 ) , nor the total blood loss ( p = 0.43 ) .
RESULTS	On the cocaine side , there was a correlation between surgical field grade and duration of surgery ( p < 0.05 ) as well as blood loss ( p < 0.05 ) and MAP ( p < 0.05 ) .
CONCLUSIONS	There is no difference in the quality of the surgical field achieved through the use of topical cocaine or adrenaline during FESS .
CONCLUSIONS	Either of these agents can be effectively used for topical decongestion at the onset of surgery .

###25067799
OBJECTIVE	Heart failure ( HF ) pathophysiology is believed to be mediated by autonomic dysfunction , including chronic sympathoexcitation and diminished baroreflex sensitivity , which correlate with mortality risk .
OBJECTIVE	Baroreflex activation therapy ( BAT ) is a device-based treatment providing chronic baroreflex activation through electrical stimulation of the carotid sinus .
OBJECTIVE	BAT chronically reduces sympathetic activity in resistant hypertension .
OBJECTIVE	The purpose of this investigation is to determine BAT effects in clinical HF .
RESULTS	In a single-centre , open-label evaluation , patients with NYHA class III HF , EF < 40 % , optimized medical therapy , and ineligible for cardiac resynchronization received BAT for 6 months .
RESULTS	Efficacy was assessed with serial measurement of muscle sympathetic nerve activity ( MSNA ) and clinical measures of quality of life and functional capacity .
RESULTS	Eleven patients participated in the trial .
RESULTS	MSNA was reduced over 6 months from 45.1 7.7 to 31.3 8.3 bursts/min and from 67.6 12.7 to 45.1 11.6 bursts/100 heartbeats , decreases of 31 % and 33 % , respectively ( P < 0.01 ) .
RESULTS	Concomitant improvements occurred in baroreflex sensitivity , EF , NYHA class , quality of life and 6 min hall walk ( 6 MHW ) distance ( P 0.05 each ) .
RESULTS	On an observational basis , hospitalization and emergency department visits for worsening HF were markedly reduced .
RESULTS	One complication , perioperative anaemia requiring transfusion , occurred during the study .
CONCLUSIONS	BAT was safe and provided chronic improvement in MSNA and clinical variables .
CONCLUSIONS	Based on present understanding of HF pathophysiology , these results suggest that BAT may improve outcome in HF by modulating autonomic balance .
CONCLUSIONS	Prospective , randomized trials to test the hypothesis are warranted .

###24989691
OBJECTIVE	We hypothesized that the psychosocial factors perceived stress and sense of personal control mediated the relationship between self-reported racism and experience of toothache .
OBJECTIVE	We hypothesized that social support moderated this relationship .
METHODS	Data from 365 pregnant Aboriginal Australian women were used to evaluate experience of toothache , socio-demographic factors , psychosocial factors , general health , risk behaviors , and self-reported racism exposure .
METHODS	Hierarchical logistic regression models estimated odds ratios ( ORs ) and 95 percent confidence intervals ( CIs ) for experience of toothache .
METHODS	Perceived stress and sense of personal control were examined as mediators of the association between self-reported racism and experience of toothache .
METHODS	Social support was examined as a moderator .
RESULTS	Self-reported racism persisted as a risk indicator for experience of toothache ( OR 1.99 , 95 percent CI 1.07-3 .72 ) after controlling for age , level of education , and difficulty paying a $ 100 dental bill .
RESULTS	The relationship between self-reported racism and experience of toothache was mediated by sense of control .
RESULTS	The direct effect of self-reported racism on experience of toothache became only marginally significant , and the indirect effect was significant ( coefficient = 0.04 , bias-corrected 95 percent CI 0.004-0 .105 , 21.2 percent of effect mediated ) .
RESULTS	Stress was insignificant as a mediator .
RESULTS	Social support was insignificant as a moderator .
CONCLUSIONS	The findings indicate that high levels of self-reported racism were associated with experience of toothache and that sense of control , but not perceived stress , mediated the association between self-reported racism and experience of toothache among this sample of pregnant Aboriginal Australian women .
CONCLUSIONS	Social support did not moderate the association between self-reported racism and experience of toothache .

###25195060
OBJECTIVE	To investigate whether betamethasone decreases the incidence of postoperative nausea/vomiting ( PONV ) and reduces postoperative pain following partial mastectomy .
METHODS	Prospective randomized , double-blinded study .
METHODS	Operating room and Postanesthesia Care Unit of a university hospital .
METHODS	80 ASA physical status 1 and 2 women scheduled for elective breast cancer surgery .
METHODS	Patients were randomly allocated to two groups in double-blinded fashion : Group B ( betamethasone ; 37 pts ) and Group C ( control ; 38 pts ) .
METHODS	Group B received 8 mg of betamethasone intravenously before the start of surgery .
METHODS	The rate of PONV and pain were recorded using a numeric rating scale ( NRS ; 0-10 ) , as well as rescue doses of antiemetics ( ondansetron ) and analgesics ( ketobemidone ) .
RESULTS	There was a significant lower incidence of postoperative nausea ( PON ) scoring NRS 1 in Group B in the 4 to 12-hour period compared with Group C ( P = 0.02 ) .
RESULTS	The cumulative incidence of PON was 57 % in Group B versus 68 % in Group C ( P = 0.27 ) .
RESULTS	The overall incidence of postoperative vomiting ( POV ) was 18 % and 20 % in Groups B and C , respectively .
RESULTS	Postoperative pain was reduced by 40 % in Group B in the 4 to 12-hour period , but the mean dose of postoperative rescue analgesic did not differ between the groups .
CONCLUSIONS	Preoperative betamethasone reduces the severity of PONV and pain in patients undergoing elective breast surgery .

###24535625
BACKGROUND	Luseogliflozin , a sodium glucose cotransporter 2 inhibitor , inhibits reabsorption of glucose in the proximal renal tubule .
BACKGROUND	It was developed for the treatment of type 2 diabetes mellitus .
METHODS	For this first human study of luseogliflozin , randomized , single-blind , placebo-controlled , single ascending dose ( 1-25mg ) and multiple ascending dose ( 5 or 10mg/day , 7days ) trials were conducted in healthy male Japanese subjects to investigate safety , pharmacokinetics , and pharmacodynamics .
RESULTS	There were no serious adverse events , adverse events leading to discontinuation , or episodes of hypoglycemia .
RESULTS	After administration of a single oral dose of luseogliflozin , its maximum plasma level ( C max ) and area under the concentration-time curve increased in a dose-dependent manner , and no food effects were observed on pharmacokinetics .
RESULTS	The mean time taken to reach C max ( T max ) ranged from 0.667 to 2.25 h.
RESULTS	The mean plasma half-life of luseogliflozin ( T 1/2 ) after multiple dosing for 7days ranged from 9.14 to 10.7 h , and no detectable accumulation of luseogliflozin was observed .
RESULTS	Urinary glucose excretion increased in a dose-dependent manner , ranging from 18.9 to 70.9 g ( single-dose study ) .
CONCLUSIONS	Luseogliflozin was well tolerated and showed favorable pharmacokinetic and pharmacodynamic profiles in healthy male Japanese subjects .

###25267740
OBJECTIVE	For patients with relapsed or refractory aggressive lymphoma , we hypothesized that gemcitabine-based therapy before autologous stem-cell transplantation ( ASCT ) is as effective as and less toxic than standard treatment .
METHODS	We randomly assigned 619 patients with relapsed/refractory aggressive lymphoma to treatment with gemcitabine , dexamethasone , and cisplatin ( GDP ) or to dexamethasone , cytarabine , and cisplatin ( DHAP ) .
METHODS	Patients with B-cell lymphoma also received rituximab .
METHODS	Responding patients proceeded to stem-cell collection and ASCT .
METHODS	Coprimary end points were response rate after two treatment cycles and transplantation rate .
METHODS	The noninferiority margin for the response rate to GDP relative to DHAP was set at 10 % .
METHODS	Secondary end points included event-free and overall survival , treatment toxicity , and quality of life .
RESULTS	For the intention-to-treat population , the response rate with GDP was 45.2 % ; with DHAP the response rate was 44.0 % ( 95 % CI for difference , -9.0 % to 6.7 % ) , meeting protocol-defined criteria for noninferiority of GDP ( P = .005 ) .
RESULTS	Similar results were obtained in a per-protocol analysis .
RESULTS	The transplantation rates were 52.1 % with GDP and 49.3 % with DHAP ( P = .44 ) .
RESULTS	At a median follow-up of 53 months , no differences were detected in event-free survival ( HR , 0.99 ; stratified log-rank P = .95 ) or overall survival ( HR , 1.03 ; P = .78 ) between GDP and DHAP .
RESULTS	Treatment with GDP was associated with less toxicity ( P < .001 ) and need for hospitalization ( P < .001 ) , and preserved quality of life ( P = .04 ) .
CONCLUSIONS	For patients with relapsed or refractory aggressive lymphoma , in comparison with DHAP , treatment with GDP is associated with a noninferior response rate , similar transplantation rate , event-free survival , and overall survival , less toxicity and hospitalization , and superior quality of life .

###24969964
OBJECTIVE	To evaluate the efficacy of two maintenance strategies compared to usual care after discharge from a pharmacist-led cardiovascular risk reduction clinic ( CRRC ) .
METHODS	Open-label , randomized-controlled trial of 200 consecutive CRRC patients that met clinic discharge criteria ( HbA1c 7 % ( 53 mmol/mol ) ; blood pressure 140/80 mmHg for those with diabetes and 140/90 mmHg for those without diabetes ; and an LDL-cholesterol 2.59 mmol/l ) .
METHODS	Participants were randomized to either quarterly group medical visits or quarterly CRRC individual clinic visits , or a usual care control arm with the standard primary care alone first in a 1:1:1 ratio , followed by a 2:2:1 ratio after first 100 patients .
METHODS	Primary outcome measures were time to failure for guideline recommended goals of HbA1c and blood pressure over 12-months .
RESULTS	Of the 200 participants randomized , 89 % had diabetes and were similar in other cardiovascular risk factors .
RESULTS	After 1-year , the HbA1c failure rate was 0.36 [ 95 % CI , 0.28-0 .47 ] per quarter for the group medical visit arm , 0.24 [ 95 % CI , 0.18-0 .33 ] per quarter for the quarterly CRRC individual arm and , 0.82 [ 95 % CI , 0.69-0 .96 ] per quarter for the usual care control arm , p < 0.001 .
RESULTS	The rate of failure for blood pressure was 0.31 [ 95 % CI , 0.23-0 .41 ] per quarter for the group medical visit arm , 0.22 [ 95 % CI , 0.16-0 .30 ] per quarter for the CRRC individual arm and , 0.53 [ 95 % CI , 0.40-0 .71 ] per quarter the control arm , p < 0.001 .
CONCLUSIONS	After discharge from a CRRC program , both individual and group interventions are more effective in maintaining glycemia and blood pressure control for patients with diabetes than usual care after 1-year of follow-up .

###24521425
BACKGROUND	While studies of HIV-infected adults on antiretroviral treatment ( ART ) report no sex differences in immune recovery and virologic response but more ART-associated complications in women , sex differences in disease progression and response to ART among children have not been well assessed .
BACKGROUND	The objective of this study was to evaluate for sex differences in response to ART in South African HIV-infected children who were randomized to continue ritonavir-boosted lopinavir ( LPV/r ) - based ART or switch to nevirapine-based ART .
METHODS	ART outcomes in HIV-infected boys and girls in Johannesburg , South Africa from 2005-2010 were compared .
METHODS	Children initiated ritonavir-boosted lopinavir ( LPV/r ) - based ART before 24 months of age and were randomized to remain on LPV/r or switch to nevirapine-based ART after achieving viral suppression .
METHODS	Children were followed for 76 weeks post-randomization and then long-term follow up continued for a minimum of 99 weeks and maximum of 245 weeks after randomization .
METHODS	Viral load , CD4 count , lipids , anthropometrics , drug concentrations , and adherence were measured at regular intervals .
METHODS	Outcomes were compared between sexes within treatment strata .
RESULTS	A total of 323 children ( median age 8.8 months , IQR 5.1-13 .5 ) , including 168 boys and 155 girls , initiated LPV/r-based ART and 195 children were randomized .
RESULTS	No sex differences in risk of virological failure ( confirmed viral load > 1000 copies/mL ) by 156 weeks post-randomization were observed within either treatment group .
RESULTS	Girls switched to nevirapine had more robust CD4 count improvement relative to boys in this group through 112 weeks post-randomization .
RESULTS	In addition , girls remaining on LPV/r had higher plasma concentrations of ritonavir than boys during post-randomization visits .
RESULTS	After a mean of 3.4 years post-randomization , girls remaining on LPV/r also had a higher total cholesterol : HDL ratio and lower mean HDL than boys on LPV/r .
CONCLUSIONS	Sex differences are noted in treated HIV-infected children even at a young age , and appear to depend on treatment regimen .
CONCLUSIONS	Future studies are warranted to determine biological mechanisms and clinical significance of these differences .
BACKGROUND	ClinicalTrials.gov Identifier : NCT00117728 .

###24652498
BACKGROUND	Chloroquine-azithromycin is being evaluated as combination therapy for malaria .
BACKGROUND	It may provide added benefit in treating or preventing bacterial infections that occur in children with malaria .
OBJECTIVE	We aim to evaluate the effect of treating clinical malaria with chloroquine-azithromycin on the incidence of respiratory-tract and gastrointestinal-tract infections compared to treatment with chloroquine monotherapy .
METHODS	We compared the incidence density and time to first events of respiratory-tract and gastrointestinal-tract infections among children assigned to receive chloroquine-azithromycin or chloroquine for all symptomatic malaria episodes over the course of 1 year in a randomized longitudinal trial in Blantyre , Malawi .
RESULTS	The incidence density ratios of total respiratory-tract infections and gastrointestinal-tract infections comparing chloroquine-azithromycin to chloroquine monotherapy were 0.67 ( 95 % confidence interval [ CI ] , .48 , .94 ) and 0.74 ( 95 % CI , .55 , .99 ) , respectively .
RESULTS	The time to first lower-respiratory-tract and gastrointestinal-tract infections were significantly longer in the chloroquine-azithromycin arm compared to the chloroquine arm ( P = .04 and P = .02 , respectively ) .
CONCLUSIONS	Children treated routinely with chloroquine-azithromycin had fewer respiratory and gastrointestinal-tract infections than those treated with chloroquine alone .
CONCLUSIONS	This antimalarial combination has the potential to reduce the burden of bacterial infections among children in malaria-endemic countries .

###24594972
BACKGROUND	Childhood eczema , or childhood atopic dermatitis , causes significant distress to children and their families through sleep disturbance and itch .
BACKGROUND	The main cause of treatment failure is nonuse of prescribed treatments .
OBJECTIVE	The objective of this study was to develop and test a Web-based intervention to support families of children with eczema , and to explore whether support from a health care professional ( HCP ) is necessary to engage participants with the intervention .
METHODS	We followed the PRECEDE-PROCEED model : regular emollient use was the target behavior we were seeking to promote and we identified potential techniques to influence this .
METHODS	LifeGuide software was used to write the intervention website .
METHODS	Carers of children with eczema were invited through primary care mail-out and randomized to 3 groups : ( 1 ) website only , ( 2 ) website plus HCP support , or ( 3 ) usual care .
METHODS	Patient-Oriented Eczema Measure ( POEM ) scores were measured online by carer report at baseline and at 12 weeks .
METHODS	Qualitative interviews were carried out with 13 HCPs ( primarily practice nurses ) and 26 participants to explore their experiences of taking part in the study .
RESULTS	A total of 143 carers were recruited through 31 practices .
RESULTS	We found a decrease of 2 in follow-up compared with baseline POEM score in 23 of 42 ( 55 % ) participants in the website only group , 16 of 49 ( 33 % ) in the usual care group , and 18 of 47 ( 38 % ) in the website plus HCP group .
RESULTS	Website use data showed that 75 of 93 ( 81 % ) participants allocated to the website groups completed the core modules , but less than half used other key components ( videos : 35 % ; regular text reminders : 39 % ) .
RESULTS	There were no consistent differences in website use between the website only or the website plus HCP groups .
RESULTS	Qualitative feedback showed that most HCPs had initial concerns about providing support for eczema self-care because this was not a condition that they felt expert in .
RESULTS	However , HCPs reported productive consultations and that they found it helpful to use the website in consultations , while observing that some participants seemed to need more support than others .
RESULTS	Qualitative interviews with participants suggested that HCP support was valued highly only by a minority , generally those who were less confident in their management of eczema or less confident using the Internet .
CONCLUSIONS	Our pilot trial demonstrated the potential for greater improvements in POEM scores in both website intervention groups and that a full-scale trial is feasible .
CONCLUSIONS	Such a trial would quantify the effectiveness and cost-effectiveness of this intervention to determine whether it should be widely promoted to families of children with newly diagnosed eczema .
CONCLUSIONS	In this study population , HCP support was not strongly valued by participants and did not lead to better outcomes or website use than use of the Web-based intervention alone .
BACKGROUND	International Standard Randomized Controlled Trial Number ( ISRCTN ) : 98560867 ; http://www.controlled-trials.com/ISRCTN98560867 ( Archived by WebCite at http://www.webcitation.org/6NcxvMtgN ) .

###25104835
BACKGROUND	Exposure-based cognitive-behavioural therapy ( CBT ) delivered via the internet has been shown to be effective for severe health anxiety ( hypochondriasis ) but has not been compared with an active , effective and credible psychological treatment , such as behavioural stress management ( BSM ) .
OBJECTIVE	To investigate two internet-delivered treatments - exposure-based CBT v. BSM - for severe health anxiety in a randomised controlled trial ( trial registration : NCT01673035 ) .
METHODS	Participants ( n = 158 ) with a principal diagnosis of severe health anxiety were allocated to 12 weeks of exposure-based CBT ( n = 79 ) or BSM ( n = 79 ) delivered via the internet .
METHODS	The Health Anxiety Inventory ( HAI ) was the primary outcome .
RESULTS	Internet-delivered exposure-based CBT led to a significantly greater improvement on the HAI compared with BSM .
RESULTS	However , both treatment groups made large improvements on the HAI ( pre-to-post-treatment Cohen 's d : exposure-based CBT , 1.78 ; BSM , 1.22 ) .
CONCLUSIONS	Exposure-based CBT delivered via the internet is an efficacious treatment for severe health anxiety .

###25470694
BACKGROUND	The efficacy of the ALK inhibitor crizotinib as compared with standard chemotherapy as first-line treatment for advanced ALK-positive non-small-cell lung cancer ( NSCLC ) is unknown .
METHODS	We conducted an open-label , phase 3 trial comparing crizotinib with chemotherapy in 343 patients with advanced ALK-positive nonsquamous NSCLC who had received no previous systemic treatment for advanced disease .
METHODS	Patients were randomly assigned to receive oral crizotinib at a dose of 250 mg twice daily or to receive intravenous chemotherapy ( pemetrexed , 500 mg per square meter of body-surface area , plus either cisplatin , 75 mg per square meter , or carboplatin , target area under the curve of 5 to 6 mg per milliliter per minute ) every 3 weeks for up to six cycles .
METHODS	Crossover to crizotinib treatment after disease progression was permitted for patients receiving chemotherapy .
METHODS	The primary end point was progression-free survival as assessed by independent radiologic review .
RESULTS	Progression-free survival was significantly longer with crizotinib than with chemotherapy ( median , 10.9 months vs. 7.0 months ; hazard ratio for progression or death with crizotinib , 0.45 ; 95 % confidence interval [ CI ] , 0.35 to 0.60 ; P < 0.001 ) .
RESULTS	Objective response rates were 74 % and 45 % , respectively ( P < 0.001 ) .
RESULTS	Median overall survival was not reached in either group ( hazard ratio for death with crizotinib , 0.82 ; 95 % CI , 0.54 to 1.26 ; P = 0.36 ) ; the probability of 1-year survival was 84 % with crizotinib and 79 % with chemotherapy .
RESULTS	The most common adverse events with crizotinib were vision disorders , diarrhea , nausea , and edema , and the most common events with chemotherapy were nausea , fatigue , vomiting , and decreased appetite .
RESULTS	As compared with chemotherapy , crizotinib was associated with greater reduction in lung cancer symptoms and greater improvement in quality of life .
CONCLUSIONS	Crizotinib was superior to standard first-line pemetrexed-plus-platinum chemotherapy in patients with previously untreated advanced ALK-positive NSCLC .
CONCLUSIONS	( Funded by Pfizer ; PROFILE 1014 ClinicalTrials.gov number , NCT01154140 . )

###24953218
BACKGROUND	Following maternal administration , local anesthetics pass into breast milk .
BACKGROUND	In the present study , we aimed to compare the passage of levobupivacaine and bupivacaine into breast milk following epidural anesthesia for cesarean delivery .
METHODS	A total of 20 women undergoing elective cesarean delivery under epidural anesthesia were randomized to receive either 0.5 % levobupivacaine or 0.5 % racemic bupivacaine via an epidural catheter .
METHODS	Immediately before and 30min , 1h , 2h , 6h , 12h and 24h after administration of epidural local anesthetic , maternal blood and breast milk samples were taken simultaneously .
METHODS	Drug concentrations in plasma and milk were determined via high-performance liquid chromatography .
METHODS	The infant 's drug exposure was determined by calculating milk/plasma ratios of levobupivacaine and bupivacaine .
RESULTS	Both levobupivacaine and bupivacaine were detected in breast milk 30min after epidural administration .
RESULTS	Concentrations of both agents showed constant and similar decreases in milk and plasma and were nearly undetectable at 24h .
RESULTS	The milk/plasma ratios were 0.340.13 for levobupivacaine and 0.370.14 for bupivacaine .
CONCLUSIONS	Both levobupivacaine and bupivacaine pass into breast milk following epidural administration .
CONCLUSIONS	The concentration of both drugs was approximately three times lower in breast milk than in maternal plasma .

###24220723
BACKGROUND	Knowledge of the skin cancer examination ( SCE ) and its practice remain relevant competency gaps among medical students .
OBJECTIVE	We elaborate on a method of SCE known as the Integrated Skin Exam and discuss the development of an instructional film that illustrates its principles .
OBJECTIVE	We assess the tool 's effect on knowledge , attitudes , and perceptions related to the SCE .
METHODS	Second-year students among 8 randomized schools viewed the film and completed pre-post questionnaires .
RESULTS	After viewing The Integrated Skin Exam film , students demonstrated improved melanoma knowledge , including identification of high-risk demographic groups ( 61 % vs 42.9 % , P < .001 ) , high-risk anatomic sites in women ( 88.6 % vs 46.5 % , P < .001 ) and men ( 92.1 % vs 34.8 % , P < .001 ) , and the ABCDEs of melanoma ( 98.4 % vs 91.2 % , P < .001 ) .
RESULTS	Students demonstrated increased confidence in the SCE ( 66.93 % vs 16.40 % , P < .001 ) and augmented intentions to practice it ( 99.05 % vs 13.9 % , P < .001 ) .
RESULTS	A greater proportion ( 70.4 % vs 41.9 % , P < .001 ) of students thought less than 3 minutes were required to integrate SCE into the routine examination .
CONCLUSIONS	Longitudinal impact of the film was not assessed .
CONCLUSIONS	The Integrated Skin Exam film introduces an integrated approach to the SCE that addresses knowledge gaps , mitigates perceived barriers , and augments intention related to practice of the SCE .

###24742126
BACKGROUND	Physical activity is associated with better physical and mental health in older adults .
BACKGROUND	Pole walking is a form of walking which may have additional health benefits in older adults , because of the addition of hand held poles , and consequent upper limb involvement .
BACKGROUND	However , few studies have examined the potential additional effects of pole walking on physical and psychosocial health in older adults compared with walking .
BACKGROUND	The aim of this study is to compare the effect of a pole walking program with the effects of a walking program , on physical and psychosocial wellbeing , in older adults in assisted living facilities .
METHODS	Sixty men and women from assisted living communities over 65 years will be recruited from senior retirement facilities and randomized into a group based , pole walking program , or walking program .
METHODS	The pole walking group will use the Exerstrider method of pole walking .
METHODS	Total duration of the programs is 12 weeks , with three sessions per week , building from 20 minute to 30 minute sessions.The primary outcome is physical function , as measured by items from the Seniors Fitness Test and hand grip strength .
METHODS	Secondary outcomes include , physical activity levels , sedentary behaviour , joint pain , and quality of life .
METHODS	All outcomes will be assessed before and after the programs , using valid and reliable measures .
CONCLUSIONS	The study will add to the evidence base for the effects of pole walking , compared with walking , on physical and psychosocial health and physical function , in healthy older adults .
CONCLUSIONS	This will improve understanding about the feasibility of pole walking programs and its specific benefits in this population .
BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12612001127897 .

###24273887
OBJECTIVE	To investigate the acute cellular rejection rate of liver transplant recipients taking or not taking calcitriol in a prospective , randomized , controlled clinical study .
METHODS	Primary liver transplant patients were randomized to receive the placebo ( arm A ) , calcium gluconate ( arm B ) or calcium gluconate plus calcitriol ( arm C ) .
METHODS	The composition of circulating T cell subpopulations was determined by flow cytometry at baseline and one week post transplant .
METHODS	The primary endpoint was acute cellular rejection rate at one month post transplant .
RESULTS	Seventy-five liver transplant recipients were eligible , including 25 patients each in arm A , B and arm C.
RESULTS	The mean baseline serum 25 - ( OH ) vitamin D content was 12.5 + / - 3.0 ( range , 2.5 to 19.5 ) ng/mL , with no statistical difference among the three arms .
RESULTS	Among 7 ( 9.33 % ) patients who developed definite acute cellular rejection ( Banff score > or = 6 ) , only 1 ( 4 % , 1/25 ) were from arm C while 6 ( 12 % , 6/50 ) of them were from either arm A or B.
RESULTS	The acute cellular rejection rate was 20 % ( 5/25 ) for arm C , 32 % ( 8/25 ) for arm A and 28 % ( 7/25 ) for arm B ( arm C vs. arm A or B , P < 0.05 ) .
RESULTS	Flow cytometric analysis showed that the proportion of circulating CD4 + CD25 ( high ) CD ( 127 - ) ( Treg ) cells in arm C increased by 63.22 % at one week post transplant ( 3.95 + / - 4.0 % ) compared to baseline ( 2.42 + / - 2.35 % ) ( P < 0.05 ) .
RESULTS	No significant difference was observed in arm A or B ( P > 0.05 in both vs. baseline ) .
RESULTS	Furthermore , no significant difference was noted among the three arms in the proportion of CD4 ( + ) CD45RA ( - ) CD45RO ( + ) , CD4 ( + ) CD25 ( low ) CD45RA ( + ) and CD4 ( + ) CD25 ( low ) CD45RA ( - ) T cells at one week post transplant compared to baseline .
CONCLUSIONS	Calcitriol has apparent beneficial effect on acute cellular rejection of liver transplants , which may be associated with increases in the proportion of circulating Treg cells .

###24247587
OBJECTIVE	Whether culture-expanded mesenchymal stem cells or whole bone marrow mononuclear cells are safe and effective in chronic ischemic cardiomyopathy is controversial .
OBJECTIVE	To demonstrate the safety of transendocardial stem cell injection with autologous mesenchymal stem cells ( MSCs ) and bone marrow mononuclear cells ( BMCs ) in patients with ischemic cardiomyopathy .
METHODS	A phase 1 and 2 randomized , blinded , placebo-controlled study involving 65 patients with ischemic cardiomyopathy and left ventricular ( LV ) ejection fraction less than 50 % ( September 1 , 2009-July 12 , 2013 ) .
METHODS	The study compared injection of MSCs ( n = 19 ) with placebo ( n = 11 ) and BMCs ( n = 19 ) with placebo ( n = 10 ) , with 1 year of follow-up .
METHODS	Injections in 10 LV sites with an infusion catheter .
METHODS	Treatment-emergent 30-day serious adverse event rate defined as a composite of death , myocardial infarction , stroke , hospitalization for worsening heart failure , perforation , tamponade , or sustained ventricular arrhythmias .
RESULTS	No patient had a treatment-emergent serious adverse events at day 30 .
RESULTS	The 1-year incidence of serious adverse events was 31.6 % ( 95 % CI , 12.6 % to 56.6 % ) for MSCs , 31.6 % ( 95 % CI , 12.6 % -56.6 % ) for BMCs , and 38.1 % ( 95 % CI , 18.1 % -61.6 % ) for placebo .
RESULTS	Over 1 year , the Minnesota Living With Heart Failure score improved with MSCs ( -6.3 ; 95 % CI , -15.0 to 2.4 ; repeated measures of variance , P = .02 ) and with BMCs ( -8.2 ; 95 % CI , -17.4 to 0.97 ; P = .005 ) but not with placebo ( 0.4 ; 95 % CI , -9.45 to 10.25 ; P = .38 ) .
RESULTS	The 6-minute walk distance increased with MSCs only ( repeated measures model , P = .03 ) .
RESULTS	Infarct size as a percentage of LV mass was reduced by MSCs ( -18.9 % ; 95 % CI , -30.4 to -7.4 ; within-group , P = .004 ) but not by BMCs ( -7.0 % ; 95 % CI , -15.7 % to 1.7 % ; within-group , P = .11 ) or placebo ( -5.2 % ; 95 % CI , -16.8 % to 6.5 % ; within-group , P = .36 ) .
RESULTS	Regional myocardial function as peak Eulerian circumferential strain at the site of injection improved with MSCs ( -4.9 ; 95 % CI , -13.3 to 3.5 ; within-group repeated measures , P = .03 ) but not BMCs ( -2.1 ; 95 % CI , -5.5 to 1.3 ; P = .21 ) or placebo ( -0.03 ; 95 % CI , -1.9 to 1.9 ; P = .14 ) .
RESULTS	Left ventricular chamber volume and ejection fraction did not change .
CONCLUSIONS	Transendocardial stem cell injection with MSCs or BMCs appeared to be safe for patients with chronic ischemic cardiomyopathy and LV dysfunction .
CONCLUSIONS	Although the sample size and multiple comparisons preclude a definitive statement about safety and clinical effect , these results provide the basis for larger studies to provide definitive evidence about safety and to assess efficacy of this new therapeutic approach .
BACKGROUND	clinicaltrials.gov Identifier : NCT00768066 .

###25064681
BACKGROUND	A combination of psychosocial interventions and medications has been highly recommended as a successful treatment package for schizophrenia .
BACKGROUND	Its cost-effectiveness has not been fully explored yet .
BACKGROUND	The aim of the present analysis was to evaluate the cost-effectiveness of antipsychotics combined with psychosocial treatment and treatment as usual for patients with early-stage schizophrenia .
METHODS	Patients with schizophrenia ( N = 1 , 268 ) were assigned to the combination of medication and psychosocial intervention or treatment as usual for up to 12 months .
METHODS	Cost analysis included direct medical costs , direct nonmedical costs and indirect costs .
METHODS	Quality-adjusted life year ( QALY ) ratings were assessed with Short - Form 6D .
RESULTS	Average monthly psychosocial intervention costs for combined treatment were higher than treatment as usual ( p = 0.005 ) , but no significant differences were found in direct costs , indirect costs , and total costs between two groups ( all p-values 0.556 ) .
RESULTS	Combined treatment was associated with significant higher QALY ratings than treatment as usual ( p = 0.039 ) .
RESULTS	Compared with treatment as usual , combined treatment resulted in a gain of 0.031 QALY ratings at an additional cost of US$ 56.4 , yielding an incremental cost-effectiveness ratio of US$ 1819.4 per QALY gained .
CONCLUSIONS	Despite some limitations , our results supported that medication combined with psychosocial treatment was more cost-effective than treatment as usual for patients with early-stage schizophrenia .
BACKGROUND	clinicaltrials.gov Identifier : NCT00654576 .

###24433640
OBJECTIVE	To evaluate T1-relaxation times of chronic myocardial infarction ( CMI ) using gadobutrol and gadopentetate dimeglumine ( Gd-DTPA ) over time and to determine the optimal imaging window for late enhancement imaging with both contrast agents .
METHODS	Twelve patients with CMI were prospectively included and examined on a 1.5 T magnetic resonance ( MR ) system using relaxivity-adjusted doses of gadobutrol ( 0.15 mmol/kg ) and Gd-DTPA ( 0.2 mmol/kg ) in random order .
METHODS	T1-relaxation times of remote myocardium ( RM ) , infarcted myocardium ( IM ) , and left ventricular cavity ( LVC ) were assessed from short-axis TI scout imaging using the Look-Locker approach and compared intraindividually using a Wilcoxon paired signed-rank test ( < 0.05 ) .
RESULTS	Within 3 min of contrast agent administration ( CA ) , IM showed significantly lower T1-relaxation times than RM with both contrast agents , indicating beginning cardiac late enhancement .
RESULTS	Differences between gadobutrol and Gd-DTPA in T1-relaxation times of IM and RM were statistically not significant through all time points .
RESULTS	However , gadobutrol led to significantly higher T1-relaxation times of LVC than Gd-DTPA from 6 to 9 min ( 220 15 ms vs. 195 30 ms p < 0.01 ) onwards , resulting in a significantly greater T1 of IM to LVC at 9-12 min ( -20 35 ms vs. 0 35 ms , p < 0.05 ) and 12-15 min ( -25 45 ms vs. -10 60 ms , p < 0.05 ) .
RESULTS	Using Gd-DTPA , comparable T1 values were reached only after 25-35 min .
CONCLUSIONS	This study indicates good delineation of IM to RM with both contrast agents as early as 3 min after administration .
CONCLUSIONS	However , we found significant differences in T1 relaxation times with greater T1 IM-LVC using 0.15 mmol/kg gadobutrol compared to 0.20 mmol/kg Gd-DTPA after 9-15 min post-CA suggesting earlier differentiability of IM and LVC using gadobutrol .

###24630742
OBJECTIVE	Negative symptoms are known to undermine functional outcomes in people with schizophrenia ; however , most studies have not accounted for whether these symptoms were primary or secondary to other psychopathological factors .
OBJECTIVE	The present study examined the impact of primary negative symptoms on functional outcomes in patients with schizophrenia .
METHODS	The sample included 1427 patients with schizophrenia who completed the baseline visit in the CATIE study .
METHODS	Symptoms were assessed with the Positive and Negative Syndrome Scale and Calgary Depression Scale , extrapyramidal side effects with the Simpson-Angus scale , and functional status with the Heinrichs-Carpenter Quality of Life Scale .
RESULTS	Negative symptoms were significantly and inversely related to each domain of functioning examined .
RESULTS	These relationships remained after statistically controlling for the influence of potential sources of secondary negative symptoms .
RESULTS	In addition , the relationships between negative symptoms and specific domains of functioning remained in patients who had mild/absent positive , depressive , anxiety and extrapyramidal symptoms .
RESULTS	Negative symptoms were associated with functional outcomes even in antipsychotic-free patients .
CONCLUSIONS	Primary negative symptoms significantly contribute to the functional impairment seen in people with schizophrenia .
CONCLUSIONS	A better understanding of the etiology and pathobiology of these symptoms is required to guide the search for effective therapeutics that promote functional recovery .

###24686046
BACKGROUND	Although ultrasound-guided supraclavicular block has a good success rate , it remains unclear whether multiple injections are superior to single injection ( SI ) .
BACKGROUND	We compared the sensory block success rate of SI versus triple injection ( TI ) .
METHODS	In this randomized double-blind study , 96 end-stage renal disease patients undergoing arteriovenous fistula creation or superficialization were randomly allocated to receive either SI or TI .
METHODS	The primary outcome was the combined score of sensory blockade of the 5 nerves ( median , ulnar , radial , medial cutaneous nerve of the forearm , and musculocutaneous ) measured at 5 , 10 , 15 , and 20 minutes after injection .
METHODS	Secondary outcome variables were the time to onset of the blockade , performance time ( time to do the block ) , separate success rate for each of the above nerves , success rate of surgical anesthesia , and the complication rate .
RESULTS	The combined success of the sensory block was 20 % to 31 % higher in the TI group than in the SI group at 10 , 15 , and 20 minutes after injection ( all P < 0.035 ) .
RESULTS	The block of the musculocutaneous nerve in the TI group was faster and more successful than in the SI group , at all time points ( all P < 0.026 ) .
RESULTS	The average time needed to perform the block was significantly longer in the TI than the SI group ( 6.5 2.1 vs 4.7 2.1 minutes , P = 0.001 ) .
RESULTS	The overall success of surgical anesthesia measured at 30 minutes did not differ significantly between the 2 groups ( 96 % in TI vs 87 % in SI , P = 0.253 ) .
CONCLUSIONS	Although the performance time of the SI technique was shorter , TI had a faster onset and resulted in a more successful block of all nerves in the first 20 minutes .

###24894410
BACKGROUND	Pancreatic ductal adenocarcinoma ( PDA ) is one of the most aggressive malignancies with marked resistance to chemo - and radiotherapy .
BACKGROUND	PDA-cancer stem cells ( CSCs ) are not targeted by current therapies and may be a reason for poor prognosis .
BACKGROUND	Studies indicate that diets rich in cabbage , broccoli , and cauliflower offer cancer preventative and therapeutic benefits .
BACKGROUND	Recent experimental studies have confirmed these findings and demonstrated that isothiocyanate , sulforaphane , and the polyphenol , quercetin , effectively reduced tumor growth and enhanced the sensitivity of the cancer cells to current chemotherapeutics .
BACKGROUND	The aim of the present study is to test the feasibility of a randomized controlled trial on the application of freeze-dried broccoli sprouts in patients with advanced PDA .
METHODS	The study is designed as a prospective randomized , double-blinded pilot trial with a treatment and a placebo-controlled arm in a single center setting .
METHODS	A total number of forty patients ( 18 years or older ) in two parallel groups with advanced , surgically non-resectable PDA under palliative chemotherapy are planned for recruitment .
METHODS	Patients in the treatment group will receive fifteen capsules of the study substance per day ( 90 mg of active sulforaphane ) during the chemotherapy treatment course .
METHODS	Patients in the placebo group will receive the same capsule size and portion distribution with inactive substances ( mainly methylcellulose ) .
METHODS	The follow-up duration is one year .
METHODS	Feasibility of the study substance , adverse effects , and patient compliance , as well as levels of serum tumor markers ( CEA , CA 19-9 ) , quality of life , and patient overall survival rates will be assessed at defined points of time .
CONCLUSIONS	The POUDER trial is expected to transfer promising experimental and epidemiological data into a clinical pilot study to assess the effectiveness of broccoli sprout extracts in the treatment of advanced PDA .
CONCLUSIONS	The study objectives will provide data on the clinical feasibility and acceptability of a supportive treatment option accompanying palliative chemotherapy .
CONCLUSIONS	Based on these results , future clinical studies to create further evidence in this field are possible .
BACKGROUND	The POUDER trial has been registered at ClinicalTrials.gov with an ID NCT01879878 and WHO with an ID U1111-1144-2013 on June 13th 2013 .

###25048310
OBJECTIVE	This study aimed to test the hypothesis that high-dose prednisolone ( 4 mg/kg/day ) may be more efficacious than usual-dose ( 2 mg/kg/day ) prednisolone for spasm resolution at 14-days in children with infantile spasms .
METHODS	This was a randomized , open-label-trial conducted at a tertiary-level-hospital from February-2012 to March-2013 .
METHODS	Children aged 3-months to 2-years presenting with infantile spasms in clusters ( at least 1 cluster/day ) with hypsarrhythmia or its variants on EEG were enrolled .
METHODS	The study participants were randomized to receive either high-dose prednisolone ( 4 mg/kg/day ) or the usual-dose ( 2 mg/kg/day ) prednisolone .
METHODS	The primary outcome measure was the proportion of children who achieved spasm freedom for 48-h at day-14 after treatment initiation as per parental reports in both the groups .
METHODS	The adverse effects were also monitored .
METHODS	The study was registered with the clinicaltrials.gov ( ClinicalTrials.gov Identifier : NCT01575639 ) .
RESULTS	Sixty-three children were randomized into the two groups with comparable baseline characteristics .
RESULTS	The proportion of children with spasm cessation on day-14 was significantly higher in the high-dose group as compared to the usual-dose group ( 51.6 % vs. 25 % , p = 0.03 ) .
RESULTS	The absolute risk reduction was 26.6 % ( 95 % confidence interval 11.5-41 .7 % ) with number needed to treat being 4 .
RESULTS	The adverse effects were comparable in both the groups .
CONCLUSIONS	High-dose prednisolone ( 4 mg/kg/d ) was more effective than low-dose prednisolone ( 2mg/kg/d ) in achieving spasm cessation at 14-days ( as per parental reports ) in children with infantile spasms .

###24439978
BACKGROUND	Erectile dysfunction ( ED ) is an independent risk factor for cardiovascular events sharing mutual risk factors with coronary artery disease .
BACKGROUND	Several guidelines for the management of ED in cardiovascular disease have been proposed , recommending cardiologists to routinely inquire about erectile function .
BACKGROUND	However , males ' specific needs and wishes regarding sexual health care in cardiology are unknown .
BACKGROUND	We sought to identify male patients ' view concerning possible improvements in sexual health care and preferred forms of sexual counseling in the cardiology practice .
METHODS	This is a cross-sectional multicentered survey study among randomly selected males visiting a cardiologist .
RESULTS	Of 388 respondents , 296 questionnaires were eligible for analysis .
RESULTS	Mean age of respondents was 62.9 years .
RESULTS	Overall , 56 % ( n = 165 ) had ED , with up to 86 % in patients with heart failure .
RESULTS	Mean bother experienced due to ED was 5.93 ( 2.57 ) on a 0 to 10 scale .
RESULTS	Most respondents indicated to feel comfortable discussing sexual health with the cardiologists ( 88 % ) .
RESULTS	Of men with ED ( n = 165 ) , 46 % would like to have a conversation with the cardiologist about possibilities to improve sexual function , 55 % would be helped if questions could be asked during consultation with a specialized nurse , and 58 % would appreciate written information .
RESULTS	Of all respondents ( n = 296 ) , 28 % ever tried a phosphodiesterase inhibitor ; 4 % received the prescription of the cardiologists .
CONCLUSIONS	Erectile dysfunction is highly prevalent in patients with a variety of cardiovascular diagnosis and care for sexual function is mandatory .
CONCLUSIONS	Patients indicated that above consultation with the cardiologist , both consultation with a specialized nurse and written information would be helpful .

###25047245
OBJECTIVE	For visually impaired individuals , motivation to be mobile and the individual 's emotional states are predetermining factors of functioning .
OBJECTIVE	In addition , loss of confidence at the time of diagnosis could inhibit the ability to make progress .
OBJECTIVE	The aim of this study is to evaluate whether Problem-Solving Treatment , a brief , structured psychological intervention , leads to better psychological well-being in people who have been recently diagnosed as blind or partially sighted .
METHODS	A pilot randomised controlled trial : the trial aims to recruit 120 individuals who have either : ( 1 ) been diagnosed with severe , irreversible sight loss , or ( 2 ) registered as blind or partially sighted within the last 3months .
METHODS	Individuals will be randomly allocated to either the intervention or control group with randomisation stratified by severity of vision loss .
METHODS	Those in the intervention arm will receive Problem-Solving Treatment , an established intervention that addresses individual 's confidence , motivation and psychological well-being by undertaking specific tasks to help individuals work through their problems , and recognising steps to problem resolution .
METHODS	Both groups will continue to receive routine care , such as mobility training .
RESULTS	The primary outcome is psychological well-being measured at 3 , 6 , and 9months after recruitment and assignment to intervention or control group .
RESULTS	Secondary outcomes include symptoms of distress , mobility and quality of life .

###24823464
BACKGROUND	5-Reductase ( 5R ) types 1 and 2 catalyze the A-ring reduction of steroids , including androgens and glucocorticoids .
BACKGROUND	5-R inhibitors lower dihydrotestosterone in benign prostatic hyperplasia ; finasteride inhibits 5R2 , and dutasteride inhibits both 5R2 and 5R1 .
BACKGROUND	In rodents , loss of 5R1 promotes fatty liver .
OBJECTIVE	Our objective was to test the hypothesis that inhibition of 5R1 causes metabolic dysfunction in humans .
METHODS	This double-blind randomized controlled parallel group study at a clinical research facility included 46 men ( 20-85 years ) studied before and after intervention .
METHODS	Oral dutasteride ( 0.5 mg daily ; n = 16 ) , finasteride ( 5 mg daily ; n = 16 ) , or control ( tamsulosin ; 0.4 mg daily ; n = 14 ) was administered for 3 months .
METHODS	Glucose disposal was measured during a stepwise hyperinsulinemic-euglycemic clamp .
METHODS	Data are mean ( SEM ) .
RESULTS	Dutasteride and finasteride had similar effects on steroid profiles , with reduced urinary androgen and glucocorticoid metabolites and reduced circulating DHT but no change in plasma or salivary cortisol .
RESULTS	Dutasteride , but not finasteride , reduced stimulation of glucose disposal by high-dose insulin ( dutasteride by -5.7 [ 3.2 ] mol/kg fat-free mass/min , versus finasteride +7.2 [ 3.0 ] , and tamsulosin +7.0 [ 2.0 ] ) .
RESULTS	Dutasteride also reduced suppression of nonesterified fatty acids by insulin and increased body fat ( by 1.6 % [ 0.6 % ] ) .
RESULTS	Glucose production and glycerol turnover were unchanged .
RESULTS	Consistent with metabolic effects of dutasteride being mediated in peripheral tissues , mRNA for 5R1 but not 5R2 was detected in human adipose tissue .
CONCLUSIONS	Dual inhibition of 5Rs , but not inhibition of 5R2 alone , modulates insulin sensitivity in human peripheral tissues rather than liver .
CONCLUSIONS	This may have important implications for patients prescribed dutasteride for prostatic disease .

###25078409
BACKGROUND	Feed intake affects the GH-IGF system and may be a key factor in determining the ovarian follicular growth rate .
BACKGROUND	In fat mares , the plasma IGF-1 concentration is high with low GH and a quick follicular growth rate , in contrast to values observed in thin mares .
BACKGROUND	Nothing is known regarding the long-term effects of differential feed intake on the IGF system .
BACKGROUND	The objective of this experiment was to quantify IGFs , IGFBPs , GH , glucose , insulin , gonadotropin and progesterone ( P4 ) in blood and in preovulatory follicular fluid ( FF ) in relation to feeding levels in mares .
METHODS	Three years prior to the experiment , Welsh Pony mares were assigned to a restricted diet group ( R , n = 10 ) or a well-fed group ( WF , n = 9 ) .
METHODS	All mares were in good health and exhibited differences in body weight and subcutaneous fat thickness .
METHODS	Follicular development was scanned daily and plasma was also collected daily .
METHODS	Preovulatory FF was collected by ultrasound-guided follicular aspiration .
METHODS	Hormone levels were assayed in FF and plasma with a validated RIA .
RESULTS	According to scans , the total number of follicles in group R was 53 % lower than group WF .
RESULTS	Insulin and IGF-1 concentrations were higher in WF than in R mares .
RESULTS	GH and IGF-2 concentrations were lower in plasma from WF mares than from R mares , but the difference was not significant in FF .
RESULTS	The IGFBP-2 / IGFBP-3 ratio in FF was not affected by feeding but was dramatically increased in R mare plasma .
RESULTS	No difference in gonadotropin concentration was found with the exception of FSH , which was higher in the plasma of R mares .
RESULTS	On the day of puncture , P4 concentrations were not affected by feeding but were higher in preovulatory FF than in plasma .
CONCLUSIONS	The bioavailability of IGF-1 or IGF-2 , represented by the IGFBP2/IGFBP3 ratio , is modified by feed intake in plasma but not in FF .
CONCLUSIONS	These differences partially explain the variability in follicular growth observed between well-fed mares and mares on restricted diets .

###24586256
OBJECTIVE	Obesity and its associated cardiometabolic co-morbidities are increasing worldwide .
OBJECTIVE	Since thyroid hormone mimetics are capable of uncoupling the beneficial metabolic effects of thyroid hormones from their deleterious effects on heart , bone and muscle , this class of drug is considered as adjacent therapeutics to weight-lowering strategies .
OBJECTIVE	This study investigated the safety and efficacy of TRC150094 , a thyroid hormone mimetic .
METHODS	This 4-week , randomized , placebo-controlled , double-blind trial was conducted in India and The Netherlands .
METHODS	Forty subjects were randomized at a 1:1 ratio to receive either TRC150094 dosed at 50 mg or placebo once daily for 4 weeks .
METHODS	Hyperinsulinemic euglycemic clamp and ( 1 ) H-Magnetic Resonance Spectroscopy ( MRS ) were performed before and after treatment .
RESULTS	At baseline , subjects were characterized by markedly impaired hepatic and peripheral insulin sensitivity .
RESULTS	TRC150094 dosed 50 mg once daily was safe and well tolerated .
RESULTS	Hepatic nor peripheral insulin sensitivity improved after TRC150094 treatment , expressed as the suppression of Endogenous Glucose Production from 59.5 to 62.1 % ; p = 0.477 , and the rate of glucose disappearance from 28.8 to 26.4 mol kg ( -1 ) min ( -1 ) , p = 0.185 .
RESULTS	TRC150094 administration did not result in differences in fasting plasma free fatty acids from 0.51 to 0.51 mmol/L , p = 0.887 or in insulin-mediated suppression of lipolysis from 57 to 54 % , p = 0.102 .
RESULTS	Also , intrahepatic triglyceride content was unaltered .
CONCLUSIONS	Collectively , these data show that , in contrast to the potent metabolic effects in experimental models , TRC150094 at a dose of 50 mg daily does not improve the metabolic homeostasis in subjects at an increased cardiometabolic risk .
CONCLUSIONS	Further studies are needed to evaluate whether TRC150094 has beneficial effects in patients with more severe metabolic derangement , such as overt diabetes mellitus and hypertriglyceridemia .
BACKGROUND	clinicaltrials.gov NCT01408667 .

###25836351
BACKGROUND	We previously observed that 30 months of inhaled corticosteroid ( ICS ) treatment can attenuate FEV1 decline in COPD , but it is unclear whether withdrawal induces a relapse .
BACKGROUND	We hypothesized that FEV1 decline , airway hyperresponsiveness ( AHR ) , and quality of life ( QOL ) deteriorate after ICS cessation even after prolonged use .
METHODS	One hundred fourteen patients with moderate to severe COPD finished randomized 6-month or 30-month treatment with fluticasone ( 500 g bid ) , 30-month treatment with fluticasone and salmeterol ( 500/50 g bid ) , or placebo ( first part of the Groningen and Leiden Universities Corticosteroids in Obstructive Lung Disease [ GLUCOLD ] study [ GL1 ] ) .
METHODS	The subsequent 5 years , patients were prospectively followed annually , treated by their physician ( GLUCOLD follow-up study [ GL2 ] ) .
METHODS	Postbronchodilator FEV1 , AHR , and QOL were initially recorded at baseline , at 30 months ( GL1 ) , and annually during GL2 .
METHODS	Analysis was performed by linear mixed-effects models .
RESULTS	Among 101 adherent patients during GL1 , 79 patients started and 58 completed GL2 .
RESULTS	Patients using ICSs during GL1 , but only using ICSs 0 % to 50 % of the time during GL2 ( n = 56 of 79 ) , had significantly accelerated annual FEV1 decline compared with GL1 ( difference GL2-GL1 [ 95 % CI ] : 30-month treatment with fluticasone and salmeterol , -68 mL/y [ -112 to -25 ] , P = .002 ; 30-month treatment with fluticasone , -73 mL/y [ -119 to -26 ] , P = .002 ) , accompanied by deterioration in AHR and QOL .
CONCLUSIONS	ICS discontinuation after 30 months in COPD can worsen lung function decline , AHR , and QOL during 5-year follow-up .
CONCLUSIONS	This suggests that ICS treatment lacks sustained disease-modifying effect after treatment cessation .
BACKGROUND	ClinicalTrials.gov ; No. : NCT00158847 ; URL : www.clinicaltrials.gov .

###24693628
OBJECTIVE	To investigate the effect of a fluoride-containing aluminocalciumsilicate nanoparticle glass dispersed aqueous solution ( Nanoseal ) on enamel and dentin , under the hypothesis that this material can form insoluble mineral deposits that confer acid resistance to the tooth structure and occlude open dentin tubules .
METHODS	Labial enamel and dentin of human extracted incisors were used .
METHODS	Morphology of the enamel and dentin artificially demineralized with a lactic acid solution that before and/or after coated with the test material were analyzed with a wavelength-dispersive X-ray spectroscopy electron probe microanalyzer with an image observation function ( SEM-EPMA ) .
METHODS	Moreover , incorporation of the calcium and silicon by enamel and dentin were also detected with SEM-EPMA .
RESULTS	Application of the fluoroaluminocalciumsilicate-based tooth coating material resulted in the deposition of substances ( nanoparticles ) onto the enamel surface porosities and open dentin tubules on the artificial lesions .
RESULTS	Prior coating with the test material reduced the demineralization-induced loss of enamel and dentin .
RESULTS	Moreover , Ca and Si incorporation into superficial enamel and dentin was detected .

###25549238
BACKGROUND	Neonatal hepatitis B vaccination has been implemented worldwide to prevent hepatitis B virus ( HBV ) infections .
BACKGROUND	Its long-term protective efficacy on primary liver cancer ( PLC ) and other liver diseases has not been fully examined .
RESULTS	The Qidong Hepatitis B Intervention Study , a population-based , cluster randomized , controlled trial between 1985 and 1990 in Qidong , China , included 39,292 newborns who were randomly assigned to the vaccination group in which 38,366 participants completed the HBV vaccination series and 34,441 newborns who were randomly assigned to the control group in which the participants received neither a vaccine nor a placebo .
RESULTS	However , 23,368 ( 67.8 % ) participants in the control group received catch-up vaccination at age 10-14 years .
RESULTS	By December 2013 , a total of 3,895 ( 10.2 % ) in the vaccination group and 3,898 ( 11.3 % ) in the control group were lost to follow-up .
RESULTS	Information on PLC incidence and liver disease mortality were collected through linkage of all remaining cohort members to a well-established population-based tumor registry until December 31 , 2013 .
RESULTS	Two cross-sectional surveys on HBV surface antigen ( HBsAg ) seroprevalence were conducted in 1996-2000 and 2008-2012 .
RESULTS	The participation rates of the two surveys were 57.5 % ( 21,770 ) and 50.7 % ( 17,204 ) in the vaccination group and 36.3 % ( 12,184 ) and 58.6 % ( 17,395 ) in the control group , respectively .
RESULTS	Using intention-to-treat analysis , we found that the incidence rate of PLC and the mortality rates of severe end-stage liver diseases and infant fulminant hepatitis were significantly lower in the vaccination group than the control group with efficacies of 84 % ( 95 % CI 23 % -97 % ) , 70 % ( 95 % CI 15 % -89 % ) , and 69 % ( 95 % CI 34 % -85 % ) , respectively .
RESULTS	The estimated efficacy of catch-up vaccination on HBsAg seroprevalence in early adulthood was 21 % ( 95 % CI 10 % -30 % ) , substantially weaker than that of the neonatal vaccination ( 72 % , 95 % CI 68 % -75 % ) .
RESULTS	Receiving a booster at age 10-14 years decreased HBsAg seroprevalence if participants were born to HBsAg-positive mothers ( hazard ratio [ HR ] = 0.68 , 95 % CI 0.47-0 .97 ) .
RESULTS	Limitations to consider in interpreting the study results include the small number of individuals with PLC , participants lost to follow-up , and the large proportion of participants who did not provide serum samples at follow-up .
CONCLUSIONS	Neonatal HBV vaccination was found to significantly decrease HBsAg seroprevalence in childhood through young adulthood and subsequently reduce the risk of PLC and other liver diseases in young adults in rural China .
CONCLUSIONS	The findings underscore the importance of neonatal HBV vaccination .
CONCLUSIONS	Our results also suggest that an adolescence booster should be considered in individuals born to HBsAg-positive mothers and who have completed the HBV neonatal vaccination series .
CONCLUSIONS	Please see later in the article for the Editors ' Summary .

###24914779
OBJECTIVE	Gabapentinoids are currently being used anecdotally for postoperative pain following photorefractive keratectomy ( PRK ) despite the lack of evidence .
OBJECTIVE	The purpose of this study is to evaluate the effectiveness of pregabalin in mitigating pain after PRK compared to the standard of care .
METHODS	One hundred thirty-five patients scheduled for PRK at the Joint Warfighter Refractive Surgery Center in San Antonio , Texas were randomized to receive either oral pregabalin 75mg twice daily for 5 days or placebo , in addition to the standard pain care regimen .
RESULTS	There was no statistically significant difference in the primary outcome of 10 % improvement in subjective pain scores between the treatment and placebo groups at any point during the postoperative period , but there was a trend for lower subjective pain scores in the pregabalin group .
RESULTS	There was a statistically significant difference in the frequency of rescue pain medications used on postoperative days 1 and 2 .
RESULTS	The pregabalin group required an average of 1.7 doses of rescue medications on postoperative day 1 versus 2.4 doses in the placebo group , and 1.7 doses versus 2.6 doses on postoperative day 2 ( P < 0.05 ) .
CONCLUSIONS	This study demonstrates that pregabalin may provide an alternative or add-on option to standard narcotics for pain relief after PRK .

###25756501
BACKGROUND	Although livestock vaccination is effective in preventing Rift Valley fever ( RVF ) epidemics , there are concerns about safety and effectiveness of the only commercially available RVF Smithburn vaccine .
BACKGROUND	We conducted a randomized controlled field trial to evaluate the immunogenicity and safety of the new RVF Clone 13 vaccine , recently registered in South Africa .
METHODS	In a blinded randomized controlled field trial , 404 animals ( 85 cattle , 168 sheep , and 151 goats ) in three farms in Kenya were divided into three groups .
METHODS	Group A included males and non-pregnant females that were randomized and assigned to two groups ; one vaccinated with RVF Clone 13 and the other given placebo .
METHODS	Groups B included animals in 1st half of pregnancy , and group C animals in 2nd half of pregnancy , which were also randomized and either vaccinated and given placebo .
METHODS	Animals were monitored for one year and virus antibodies titers assessed on days 14 , 28 , 56 , 183 and 365 .
RESULTS	In vaccinated goats ( N = 72 ) , 72 % developed anti-RVF virus IgM antibodies and 97 % neutralizing IgG antibodies .
RESULTS	In vaccinated sheep ( N = 77 ) , 84 % developed IgM and 91 % neutralizing IgG antibodies .
RESULTS	Vaccinated cattle ( N = 42 ) did not develop IgM antibodies but 67 % developed neutralizing IgG antibodies .
RESULTS	At day 14 post-vaccination , the odds of being seropositive for IgG in the vaccine group was 3.6 ( 95 % CI , 1.5 - 9.2 ) in cattle , 90.0 ( 95 % CI , 25.1 - 579.2 ) in goats , and 40.0 ( 95 % CI , 16.5 - 110.5 ) in sheep .
RESULTS	Abortion was observed in one vaccinated goat but histopathologic analysis did not indicate RVF virus infection .
RESULTS	There was no evidence of teratogenicity in vaccinated or placebo animals .
CONCLUSIONS	The results suggest RVF Clone 13 vaccine is safe to use and has high ( > 90 % ) immunogenicity in sheep and goats but moderate ( > 65 % ) immunogenicity in cattle .

###25934131
BACKGROUND	Polyunsaturated fatty acid ( PUFA ) metabolism abnormalities have been long implicated in the etiology of schizophrenia .
BACKGROUND	Although several randomized clinical trials have been carried out to assess the efficacy of omega-3 PUFA as add-on therapy in reducing psychopathology in populations of chronic patients with schizophrenia , only a few concern first-episode schizophrenia .
BACKGROUND	The majority of these studies used a 12-week intervention based on ethyl-eicosapentaenoic acid ( ethyl-EPA ) , however , with conflicting results .
BACKGROUND	An intervention based on docosahexaenoic acid plus EPA has not been used in first-episode schizophrenia studies so far .
BACKGROUND	No add-on supplementation studies have been carried out in medicated first-episode schizophrenia patients to assess the efficacy of omega-3 PUFA in preventing relapses .
METHODS	A randomized placebo-controlled one-center trial will be used to compare the efficacy of 26-week intervention , composed of either 1320mg/day of EPA and 880mg/day of DHA , or olive oil placebo with regard to symptom severity and relapse rate in first-episode schizophrenia patients .
METHODS	Eighty-two patients ( aged 16-35 ) will be recruited for the study .
METHODS	Eligible patients will be randomly allocated to one of two intervention arms : an active arm or a placebo arm ( olive oil ) .
METHODS	The primary outcome measure of the clinical evaluation is schizophrenia symptom severity measured by the Positive and Negative Syndrome Scale ( PANSS ) .
METHODS	Other outcomes include depressive symptoms , patient functioning and the level of insight .
METHODS	Correlates of change measured during the study will include structural brain changes , oxidative stress and defense , as well as neuroplasticity indicators .
METHODS	Metabolic syndrome components will also be assessed throughout the study .
CONCLUSIONS	By comparing 26-week administration of EPA+DHA or ( placebo ) olive oil as add-on therapy in reducing symptom severity and one-year relapse rate in patients with first episode schizophrenia , it is intended to provide new insights into the efficacy of omega-3 PUFA and correlates of change , and contribute to the improvement of mental health care for individuals suffering from schizophrenia .
BACKGROUND	This study has been registered at Clinical Trials.gov with the following number : NCT02210962 .

###24252674
OBJECTIVE	To investigate the effects and mechanism of postoperative insulin resistance in gastrectomy patients with preoperative oral carbohydrate .
METHODS	From April to October 2011 , 60 consecutive gastric cancer patients met inclusion criteria were divided into oral carbohydrate group and placebo group by randomized double-blind principles .
METHODS	Resting energy expenditure ( REE ) , fasting blood glucose , insulin and triglyceride level were detected in 4 hours preoperatively .
METHODS	The 500 ml carbohydrate or placebo were administrated orally 2-3 hours before anaesthesia .
METHODS	Two group patients underwent radical distal subtotal gastrectomy under epidural compounded intravenous anesthesia .
METHODS	After laparotomy and before the abdomen was closed , a piece of rectus abdominis was taken and fixed in 3 % glutaraldehyde .
METHODS	REE , fasting blood glucose , insulin and triglyceride level were detected immediately after surgery .
METHODS	The changes of insulin resistance index , blood triglycerides level , REE and respiratory quotient were compared pre - and post-operatively .
METHODS	The changes of rectus abdominis mitochondrial ultrastructure were observed by transmission electron microscopy respectively .
RESULTS	There were 48 patients ( 34 males and 14 females ) completed the trial .
RESULTS	The 24 and 24 patients in oral placebo and carbohydrate groups respectively .
RESULTS	In oral placebo group , post-operative insulin resistance index , REE , respiratory quotient , serum triglyceride level and the rectus abdominis mitochondrial damage index were 12.68 3.13 , ( 1458 169 ) kcal/d , 0.73 0.42 , ( 0.53 0.24 ) g/L and 1.14 0.33 , respectively .
RESULTS	And the above items were 5.67 1.40 , ( 1341 110 ) kcal/d , 0.79 0.22 , ( 1.04 0.97 ) g/L and 0.92 0.19 in oral carbohydrate groups respectively .
RESULTS	All difference was statistically significant ( t = 6.646 , 2.851 , 6.546 , 2.542 and 2.730 , all P < 0.05 ) .
RESULTS	Oral placebo group showed a markedly swollen mitochondria , steep membrane was not clear , mitochondria appeared vacuolated changes .
CONCLUSIONS	Preoperative oral carbohydrate could reduce the insulin resistance and REE , improve the material metabolism status in radical gastrectomy patients .
CONCLUSIONS	The possible mechanisms should be related to promotion of insulin release and protection of mitochondrial function .

###25084682
BACKGROUND	Colorectal cancer ( CRC ) screening is effective but underutilized .
BACKGROUND	Although physician recommendation is an important predictor of screening , considerable variation in CRC screening completion remains .
OBJECTIVE	To characterize the influence of patient trust in care providers on CRC screening behavior .
METHODS	Data were collected as part of a cluster-randomized CRC screening intervention trial performed in the San Francisco Community Health Network from March 2007 to January 2012 ( analysis , Spring 2012 ) .
METHODS	All study participants received a recommendation to complete CRC screening from their primary care provider ( PCP ) .
METHODS	Included participants were aged 50-79 years , not current with screening , and completed the Wake Forest Trust Scale ( WFTS ) measuring trust in PCPs and doctors in general .
METHODS	Primary outcome was CRC screening completion ( colonoscopy or fecal occult blood testing ) within 12 months following enrollment .
METHODS	Multivariable association adjusted for race/ethnicity , language , and other sociodemographics was estimated using generalized estimating equations with logit link and binomial distribution .
RESULTS	WFTS response was 70.3 % ( 701 ) .
RESULTS	Most participants ( 83 % ) were Latino , Asian , or black .
RESULTS	Most had income < $ 30,000 ( 96 % ) and public health insurance ( 86 % ) .
RESULTS	Higher trust in PCP was associated with screening completion ( OR = 1.11 , 95 % CI = 1.03 , 1.17 ) , but trust in doctors was not ( OR = 1.02 , 95 % CI = 0.82 , 1.28 ) .
RESULTS	Race , language , and other sociodemographic factors were not significant in multivariable analysis .
CONCLUSIONS	After controlling for traditional factors , trust in PCP remained the only significant driver of CRC screening completion in low-income patients .
CONCLUSIONS	Interventions to promote CRC screening may be improved by including efforts to enhance patient trust in PCP .

###24434948
BACKGROUND	Prematurity and the associated risk for bronchopulmonary dysplasia ( BPD ) remain a significant threat to extremely low birth weight ( ELBW ) infants .
BACKGROUND	Vitamin A has been considered a therapeutic alternative in reducing the rate of BPD and mortality .
OBJECTIVE	To investigate whether early postnatal , additional high-dose oral vitamin A supplementation for 28 days is more efficient in reducing BPD or death in ELBW infants than placebo treatment .
METHODS	This is a multicenter , double-blind RCT comparing postnatal high-dose oral vitamin A supplementation ( 5,000 IU vitamin A/kg/day vs. placebo ) for 28 days in ELBW neonates requiring mechanical ventilation , noninvasive ventilatory support or supplemental oxygen at 24 h of age .
METHODS	The primary end point is the proportion of children who died before 36 weeks ' gestational age or developed moderate or severe BPD .
METHODS	BPD is defined as the need for supplemental oxygen to maintain SaO2 of 92 % at rest at 36 weeks ' postmenstrual age ( PMA ) .
METHODS	Clinical secondary end points include the following : BPD ( including mild form ) , intraventricular hemorrhage , periventricular leukomalacia , retinopathy of prematurity , necrotizing enterocolitis , total number of days of mechanical ventilation and oxygen supplementation , and safety and tolerability of high-dose vitamin A supplementation .
CONCLUSIONS	The results of the NeoVitaA trial will provide robust data with regard to the efficacy of high-dose oral vitamin A supplementation in reducing the incidence of BPD or death at 36 weeks ' PMA in ELBW infants .

###24383431
BACKGROUND	Research on the role of nutrition in type 2 diabetes has largely focused on macro/micronutrient composition and dietary fiber intake , while fewer studies have tested the effects of differing food choice .
BACKGROUND	Some observational studies and short-term intervention studies suggest that a food pattern mimicking the diet with which humans evolved positively influences glucose control and associated endocrine systems .
BACKGROUND	Such a food pattern mainly differs from other common healthy food patterns in its absence of cereal grains and dairy products .
BACKGROUND	The primary aim of this pilot study is to determine the effect of two healthy diets with or without cereal grains and dairy products on glucose control , while keeping participants ' weight stable and other food parameters , such as macro/micronutrient composition , dietary fiber and glycemic load , the same in both diets .
METHODS	We intend to include 15 adult patients with a medical diagnosis of type 2 diabetes mellitus with or without medication and with an increased waist circumference ( 80cm for women and94cm for men ) in a random-order cross-over diet intervention study during two periods of four-weeks separated by a six-week washout period .
METHODS	Patients will be instructed to eat two healthy diets according to official dietary guidelines with respect to macro/micronutrient composition and fiber content , but differing in the type of food included , with one diet being without cereal grains and dairy products .
METHODS	Lunch will be served in a hospital kitchen for control of nutrient intake , while the rest of the meals will be eaten at home according to specific directions .
METHODS	The energy content of the diets will be individually adjusted to maintain a stable body weight during the two four-week intervention periods .
METHODS	Primary outcomes will be change in fasting plasma glucagon and fructosamine , while secondary outcomes include change in fasting glucose and glycated hemoglobin , glucose and glucagon response during oral glucose tolerance test , blood lipids , blood pressure , C-reactive protein , body composition , quality of life , subjective experience with the two diets , satiety scores and changes in medication .
CONCLUSIONS	Using these results , we will assess the need to conduct larger and longer studies with similar design .
BACKGROUND	This trial was registered at clinicaltrials.gov as NCT01891955 and Spanish Agency of Medication and Sanitary Products ( AEMPS ) registration code : MFV-ADI-2013-01 .

###25046624
BACKGROUND	Curcumin , the principal curcuminoid derived from the spice turmeric , influences several biological mechanisms associated with major depression , namely those associated with monoaminergic activity , immune-inflammatory and oxidative and nitrosative stress pathways , hypothalamus-pituitary-adrenal ( HPA ) axis activity and neuroprogression .
BACKGROUND	We hypothesised that curcumin would be effective for the treatment of depressive symptoms in individuals with major depressive disorder .
METHODS	In a randomised , double-blind , placebo-controlled study , 56 individuals with major depressive disorder were treated with curcumin ( 500 mg twice daily ) or placebo for 8 weeks .
METHODS	The primary measure was the Inventory of Depressive Symptomatology self-rated version ( IDS-SR30 ) .
METHODS	Secondary outcomes included IDS-SR30 factor scores and the Spielberger State-Trait Anxiety Inventory ( STAI ) .
RESULTS	From baseline to week 4 , both curcumin and placebo were associated with improvements in IDS-SR30 total score and most secondary outcome measures .
RESULTS	From weeks 4 to 8 , curcumin was significantly more effective than placebo in improving several mood-related symptoms , demonstrated by a significant group x time interaction for IDS-SR30 total score ( F1 , 53 = 4.22 , p = .045 ) and IDS-SR30 mood score ( F1 , 53 = 6.51 , p = .014 ) , and a non-significant trend for STAI trait score ( F1 , 48 = 2.86 , p = .097 ) .
RESULTS	Greater efficacy from curcumin treatment was identified in a subgroup of individuals with atypical depression .
CONCLUSIONS	Partial support is provided for the antidepressant effects of curcumin in people with major depressive disorder , evidenced by benefits occurring 4 to 8 weeks after treatment .
CONCLUSIONS	Investigations with larger sample sizes , over extended treatment periods , and with varying curcumin dosages are required .

###25491041
BACKGROUND	Malaria continues to be a prominent global public health challenge .
BACKGROUND	This study tested the effectiveness of two service delivery models for reducing the malaria burden , e.g. supportive supervision of community health workers ( CHW ) and community mobilization in promoting appropriate health-seeking behaviour for febrile illnesses in Odisha , India .
METHODS	The study population comprised 120 villages from two purposively chosen malaria-endemic districts , with 40 villages randomly assigned to each of the two treatment arms , one with both supportive supervision and community mobilization and one with community mobilization alone , as well as an observational control arm .
METHODS	Outcome measures included changes in the utilization of bed nets and timely care-seeking for fever from a trained provider compared to the control group .
METHODS	Analysis was by intention-to-treat .
RESULTS	Significant improvements were observed in the reported utilization of bed nets in both intervention arms ( 84.5 % in arm A and 82.4 % in arm B versus 78.6 % in the control arm ; p < 0.001 ) .
RESULTS	While overall rates of treatment-seeking were equal across study arms , treatment-seeking from a CHW was higher in both intervention arms ( 28 % ; p = 0.005 and 27.6 % ; p = 0.007 ) than in the control arm ( 19.2 % ) .
RESULTS	Fever cases were significantly more likely to visit a CHW and receive a timely diagnosis of fever in the combined interventions arm than in the control arm ( 82.1 % vs. 67.1 % ; p = 0.025 ) .
RESULTS	Care-seeking from trained providers also increased with a substitution away from untrained providers .
RESULTS	Further , fever cases from the combined interventions arm ( 60.6 % ; p = 0.004 ) and the community mobilization arm ( 59.3 % ; p = 0.012 ) were more likely to have received treatment from a skilled provider within 24 hours than fever cases from the control arm ( 50.1 % ) .
RESULTS	In particular , women from the combined interventions arm were more likely to have received timely treatment from a skilled provider ( 61.6 % vs. 47.2 % ; p = 0.028 ) .
CONCLUSIONS	A community-based intervention combining the supportive supervision of community health workers with intensive community mobilization and can be effective in improving care-seeking and preventive behaviour and may be used to strengthen the national malaria control programme .

###25145762
OBJECTIVE	To compare immediate and 12h postoperative removal of urinary catheter after elective cesarean section .
METHODS	In a prospective clinical trial at a university teaching hospital , 300 eligible women admitted for primary or repeat elective cesarean section were randomized into two equal groups .
METHODS	In group A , the catheter was removed immediately after the procedure ; whereas in group B , the catheter was removed 12h postoperatively .
RESULTS	The incidence of postoperative significant bacteruria ( p = 0.020 ) , dysuria ( p = 0.030 ) , burning on micturition ( p = 0.016 ) , urinary frequency ( p = 0.031 ) , and urgency ( p = 0.011 ) were significantly lower in group A compared with group B.
RESULTS	The mean postoperative ambulation time ( p < 0.001 ) , time till the first voiding ( p < 0.001 ) , and length of hospital stay ( p < 0.001 ) were also significantly shorter in group A.
RESULTS	There were no significant differences between the two groups in the incidence of urinary retention necessitating recatheterization ( p = 0.371 ) .
CONCLUSIONS	Immediate removal of urinary catheter after elective cesarean section is associated with lower risk of urinary infection and earlier postoperative ambulation .

###24635528
BACKGROUND	Scoliosis repair is a major orthopaedic surgery associated with severe post-operative pain .
BACKGROUND	Ketamine and magnesium have an established efficacy as morphine-sparing agents .
BACKGROUND	Our purpose was to evaluate the morphine-sparing effect of both magnesium and ketamine given simultaneously compared with ketamine alone during scoliosis surgery .
METHODS	Fifty patients scheduled for posterior instrumentation were randomised in a prospective double-blind study .
METHODS	The Gr ( K + Mg ) received , after induction , an intravenous ( IV ) bolus of ketamine 0.2 mg/kg and magnesium 50 mg/kg , followed by continuous infusion of ketamine ( 0.15 mg/kg/h ) and magnesium ( 8 mg/kg/h ) until extubation .
METHODS	The Gr ( K ) received the same dose of ketamine associated with bolus and continuous infusion of normal saline .
METHODS	All patients received multimodal analgesia associated with IV morphine administered via patient-controlled analgesia pump .
METHODS	Morphine consumption , visual analogue scale ( VAS ) pain scores and occurrence of side effects were followed until 48 h post-operatively .
METHODS	Sleep quality and patient satisfaction were also followed .
METHODS	P < 0.05 was considered statistically significant .
RESULTS	The average cumulative morphine consumption was significantly lower in the Gr ( K + Mg ) compared with the Gr ( K ) at post-operative hours 4 , 8 , 12 , 18 , 30 , 36 and 48 .
RESULTS	The relative difference in the post-operative morphine consumption was 29.5 % : Gr ( K + Mg ) 51.53 mg vs. Gr ( K ) 73.16 mg .
RESULTS	VAS scores were not statistically different between the two groups .
RESULTS	However , qualities of sleep and satisfaction scores on the first night were significantly better in the Gr ( K + Mg ) ( P = 0.027 and P = 0.016 , respectively ) .
CONCLUSIONS	Ketamine and magnesium association reduces the post-operative morphine consumption after scoliosis surgery .
CONCLUSIONS	It seems to provide a better sleep quality and improves patient satisfaction .

###25059500
BACKGROUND	Prolonged sitting time has been identified as a health risk factor .
BACKGROUND	Sit-stand workstations allow desk workers to alternate between sitting and standing throughout the working day , but not much is known about their acceptability and feasibility .
BACKGROUND	Hence , the aim of this study was to qualitatively evaluate the acceptability , feasibility and perceptions of using sit-stand workstations in a group of desk-based office workers .
METHODS	This article describes the qualitative evaluation of the randomized controlled cross-over Stand@Work pilot trial .
METHODS	Participants were adult employees recruited from a non-government health agency in Sydney , Australia .
METHODS	The intervention involved using an Ergotron Workfit S sit-stand workstation for four weeks .
METHODS	After the four week intervention , participants shared their perceptions and experiences of using the sit-stand workstation in focus group interviews with 4-5 participants .
METHODS	Topics covered in the focus groups included patterns of workstation use , barriers and facilitators to standing while working , effects on work performance , physical impacts , and feasibility in the office .
METHODS	Focus group field notes and transcripts were analysed in an iterative process during and after the data collection period to identify the main concepts and themes .
RESULTS	During nine 45-min focus groups , a total of 42 participants were interviewed .
RESULTS	Participants were largely intrinsically motivated to try the sit-stand workstation , mostly because of curiosity to try something new , interest in potential health benefits , and the relevance to the participant 's own and organisation 's work .
RESULTS	Most participants used the sit-stand workstation and three common usage patterns were identified : task-based routine , time-based routine , and no particular routine .
RESULTS	Common barriers to sit-stand workstation use were working in an open plan office , and issues with sit-stand workstation design .
RESULTS	Common facilitators of sit-stand workstation use were a supportive work environment conducive to standing , perceived physical health benefits , and perceived work benefits .
RESULTS	When prompted , most participants indicated they were interested in using a sit-stand workstation in the future .
CONCLUSIONS	The use of a sit-stand workstation in this group of desk-based office workers was generally perceived as acceptable and feasible .
CONCLUSIONS	Future studies are needed to explore this in different desk-based work populations and settings .

###25060017
OBJECTIVE	The aim was to investigate whether a strategy of direct drug-eluting stent ( DES ) implantation without pre-dilation is associated with a reduced incidence of restenosis compared with CS with pre-dilation or provisional stenting ( PS ) .
BACKGROUND	Previous studies were performed comparing direct stenting ( DS ) with conventional stenting ( CS ) after pre-dilation ; however , none of these in the DES era .
BACKGROUND	Therefore , the STRESSED ( direct Stenting To reduce REStenosis in Stent Era with Drug elution ) study was designed and carried out .
METHODS	A total of 600 patients with angina pectoris or recent myocardial infarction were randomized to a DS , CS , or PS strategy .
METHODS	The primary endpoint was the mean minimal lumen diameter at 9-month follow-up angiography .
METHODS	Secondary endpoints were clinical procedural success defined as angiographic success without in-hospital major adverse cardiac events ( MACE ) , and MACE at 9-month and 2-year follow-up .
RESULTS	Stent implantation in the DS group was 98 % , 99 % in the CS group , and 77 % in the PS group .
RESULTS	Percutaneous coronary intervention success was 99 % in all groups .
RESULTS	The minimal lumen diameter at 9-month follow-up was 2.12 0.58 mm ( DS ) , 2.17 0.67 mm ( CS ) , and 1.99 0.69 mm ( PS ) , p = 0.556 for comparison of DS with CS , p = 0.073 for comparison of DS with PS .
RESULTS	The absolute difference was-0 .05 ( DS to CS ) , 95 % confidence interval : -0.19 to-0 .09 , p = 0.48 and 0.13 ( DS to PS ) , confidence interval : -0.02 to-0 .27 , p = 0.087 .
RESULTS	Restenosis was found in 3.4 % ( DS ) , 6.7 % ( CS ) , and 11.5 % ( PS ) , p = 0.025 .
RESULTS	At 9-month and 2-year follow-up , MACE occurred in 6.8 % and 11.5 % ( DS ) , 4.6 % and 10.3 % ( CS ) , and 7.6 % and 13.8 % ( PS ) ( p = 0.439 and 0.536 ) , respectively .
CONCLUSIONS	Direct DES implantation compared with conventional DES implantation did not reduce restenosis .
CONCLUSIONS	Provisional stenting , however , was associated with a higher rate of restenosis .
CONCLUSIONS	This did not translate into a difference in the rate of MACE .
CONCLUSIONS	( STRESSED study : direct Stenting To reduce REStenosis in Stent Era with Drug elution ; ISRCTN41213536 ) .

###24413493
BACKGROUND	The vaginal microbiota may play a role in mediating susceptibility to sexually transmitted infections , including Trichomonas vaginalis ( TV ) .
METHODS	Data were analyzed from HIV-1-seronegative women participating in HIV Prevention Trials Network Protocol 035 .
METHODS	At quarterly visits for up to 30 months , participants completed structured interviews and specimens were collected for genital tract infection testing .
METHODS	T. vaginalis was detected by saline microscopy .
METHODS	Bacterial vaginosis ( BV ) was characterized by Gram stain using the Nugent score ( BV = 7-10 ; intermediate = 4-6 ; normal = 0-3 [ reference group ] ) .
METHODS	Cox proportional hazards models stratified by study site were used to assess the association between Nugent score category at the prior quarterly visit and TV acquisition .
RESULTS	In this secondary analysis , 2920 participants from Malawi , South Africa , United States , Zambia , and Zimbabwe contributed 16,259 follow-up visits .
RESULTS	Bacterial vaginosis was detected at 5680 ( 35 % ) visits , and TV was detected at 400 ( 2.5 % ) visits .
RESULTS	Adjusting for age , marital status , hormonal contraceptive use , unprotected sex in the last week and TV at baseline , intermediate Nugent score , and BV at the prior visit were associated with an increased risk of TV ( intermediate score : adjusted hazard ratio [ aHR ] , 1.73 ; 95 % confidence interval [ CI ] , 1.21-2 .19 ; BV : aHR , 2.40 ; 95 % CI , 1.92-3 .00 ) .
RESULTS	Sensitivity analyses excluding 211 participants with TV at baseline were similar to those from the full study population ( intermediate score : aHR , 1.54 ; 95 % CI , 1.10-2 .14 ; BV : aHR , 2.23 ; 95 % CI , 1.75-2 .84 ) .
CONCLUSIONS	Women with a Nugent score higher than 3 were at an increased risk for acquiring TV .
CONCLUSIONS	If this relationship is causal , interventions that improve the vaginal microbiota could contribute to reductions in TV incidence .

###25565530
BACKGROUND	Habitual exposure to carbon dioxide ( CO2 ) is expected , but it is not proven , to dull ventilatory sensitivity to co2 by reducing hypercapnic ventilatory response ( HCVR ) as it is expressed by the slope of the derived response curve ( CO2 sensitivity : VE/PetCO2 ) .
BACKGROUND	It was hypothesized that HCVR is decreased by repeated breath hold maximal efforts ( RBHE ) before and after apnea training in comparison with no training and the control condition .
METHODS	Two groups of breath holders , a control ( CBH ) group and novices to breath hold activities ( NBH ) , visited the laboratory on four different occasions .
METHODS	In the first visit , subjects performed a HCVR test , whereas in the second visit they completed five successive RBHE separated by 2-min intervals .
METHODS	Another HCVR test was performed 2 min after cessation of the last apnea .
METHODS	For the next 14 d , only the NBH group trained by performing daily five RBHE separated by 2-min intervals .
METHODS	Subsequently , in a third and a fourth condition , subjects repeated the experimental protocol of the second and first visit .
RESULTS	Although breath hold time ( BHT ) increased after apnea training in the NBH group by ~ 46 % , CO2 sensitivity slopes were not different among experimental conditions and groups ( 2.8 0.3 , 2.9 0.4 L min ( 1 ) mmHg ( 1 ) in the CBH and 2.7 0.5 , 2.7 0.3 L min ( 1 ) mmHg ( 1 ) in the NBH during the second and third visit , respectively ) .
CONCLUSIONS	HCVR after five RBHE or 14 d of apnea training was not decreased despite the achieved BHT enhancement .
CONCLUSIONS	Hypercapnic dullness of ventilation is a complex biological process which takes more than 14 d of training to develop .
CONCLUSIONS	Bourdas DI , Tsakiris TS , Pavlakis KI , Triantafillou DV , Geladas ND .
CONCLUSIONS	Repeated apneas and hypercapnic ventilatory response before and after apnea training .

###24379010
BACKGROUND	Olive oil-based lipid emulsion ( LE ) and medium chain triglyceride/long chain triglyceride ( MCT/LCT ) emulsion are both LEs with low -6 polyunsaturated fat acids ( PUFAs ) content .
BACKGROUND	However , which one of these LEs is associated with a lower infection risk in patients receiving parenteral nutrition ( PN ) remains unclear .
BACKGROUND	The aim of the study was to compare the effects of the two LEs in PN in esophageal cancer patients undergoing surgery .
METHODS	Patients with resectable esophageal carcinoma were recruited and allocated randomly to two groups .
METHODS	The test group was given enteral nutrition ( EN ) with PN containing olive oil-based LE after tumor resection for 7 days , and the patients in the control group were supported by EN with MCT/LCT emulsion-based PN after surgery for the same time period .
METHODS	Immunological markers and inflammatory indicators were tested and perioperative clinical outcomes were determined .
METHODS	The trial was registered in the Chinese Clinical Trial Register , number ChiCTR-TRC-13003562 .94 Patients were recruited , and grouped ( olive oil-based LE , n = 46 and MCT/LCT , n = 48 ) , matched for sex , age , body mass index , histological type , TNM stage , and nutrition risk screening ( NRS ) 2002 score .
RESULTS	There were no differences in perioperative fever ( > 38 C ) , infectious complications , length of hospital stay ( > 14 days ) , length of critical care stay ( > 2 days ) , time for oral food intake , and in-hospital mortality between the two groups .
RESULTS	The test group showed a higher increase in IgG level compared with the MCT/LCT group ( p = 0.028 ) .
RESULTS	There was no difference in other immunological markers and inflammatory indicators between the two groups .
CONCLUSIONS	PN containing olive oil-based or MCT/LCT LEs had similar effects on perioperative outcome , cell-mediated immune function and inflammatory response in esophageal cancer patients who had undergone surgery and were receiving EN .

###25118980
BACKGROUND	Cardiac surgery is accompanied by an increase of oxidative stress , a significantly reduced antioxidant ( AOX ) capacity , postoperative inflammation , all of which may promote the development of organ dysfunction and an increase in mortality .
BACKGROUND	Selenium is an essential co-factor of various antioxidant enzymes .
BACKGROUND	We hypothesized a less pronounced decrease of circulating selenium levels in patients undergoing off-pump coronary artery bypass ( OPCAB ) surgery due to less intraoperative oxidative stress .
METHODS	In this prospective randomised , interventional trial , 40 patients scheduled for elective coronary artery bypass grafting were randomly assigned to undergo either on-pump or OPCAB-surgery , if both techniques were feasible for the single patient .
METHODS	Clinical data , myocardial damage assessed by myocard specific creatine kinase isoenzyme ( CK-MB ) , circulating whole blood levels of selenium , oxidative stress assessed by asymmetric dimethylarginine ( ADMA ) levels , antioxidant capacity determined by glutathionperoxidase ( GPx ) levels and perioperative inflammation represented by interleukin-6 ( IL-6 ) levels were measured at predefined perioperative time points .
RESULTS	At end of surgery , both groups showed a comparable decrease of circulating selenium concentrations .
RESULTS	Likewise , levels of oxidative stress and IL-6 were comparable in both groups .
RESULTS	Selenium levels correlated with antioxidant capacity ( GPx : r = 0.720 ; p < 0.001 ) and showed a negative correlation to myocardial damage ( CK-MB : r = -0.571 , p < 0.001 ) .
RESULTS	Low postoperative selenium levels had a high predictive value for the occurrence of any postoperative complication .
CONCLUSIONS	OPCAB surgery is not associated with less oxidative stress and a better preservation of the circulating selenium pool than on-pump surgery .
CONCLUSIONS	Low postoperative selenium levels are predictive for the development of complications .
BACKGROUND	ClinicalTrials.gov NCT01409057 .

###25358225
BACKGROUND	Post-operative nausea and vomiting is one of the most frequently occurring side effects affecting one third of the cases .
BACKGROUND	Objective of the study was to compare the efficacy of ondansetron alone and ondansetron plus dexamethasone in preventing postoperative nausea and vomiting after middle ear surgery .
METHODS	This randomized controlled trial was conducted at the Anaesthesia and ENT departments of Ayub Medical College , Abbottabad from January-June 2012 .
METHODS	Forty American Society of Anaesthesiologists ( ASA ) I and 2 physical status patients undergoing middle ear surgery were divided into two groups by blocked randomization .
METHODS	Patients in group-1 ( n = 20 ) received ondansetron 4 mg while group-II ( n = 20 ) received ondansetron 4 mg with dexamethasone 8 mg just before start of operation .
METHODS	The whole postoperative period of 24 hours was divided into two phases , early 0-6 hours and late phase 6-24 hour .
RESULTS	Nausea score and its frequency was significantly higher in Group-I ( p < 0.05 ) .
RESULTS	Vomiting and its frequency were found more in group-I patients .
RESULTS	In Group-II , the nausea score was significantly less ( p < 0.01 ) at 6 and 24 hours after surgery .
RESULTS	The total incidence of vomiting was reduced from 28 % in group-1 to 6 % in group-II .
RESULTS	Rescue antiemetic requirement was significantly less ( p < 0.01 ) in group-II .
CONCLUSIONS	Prophylaxis with a combination of ondansetron and dexamethasone decreased the incidence of nausea and vomiting after middle ear surgery .

###24286534
OBJECTIVE	Ulcerative colitis ( UC ) is a chronic , relapsing and remitting intestinal inflammatory disorder .
OBJECTIVE	Zinc is known to be efficacious for the repair of damaged tissue and has been shown to protect against gastric ulceration .
OBJECTIVE	This study focused on Polaprezinc ( PZ ) , N - ( 3-aminopropionyl ) - L-histidinato zinc , which accelerates ulcer healing through actions such as prostaglandin-independent cytoprotection and antioxidative activity .
METHODS	In this randomized , placebo-controlled , investigator-blinded trial , 28 patients with active UC at The Jikei University Hospital were randomly divided into two groups : one treated with a 150 mg PZ enema ( n = 18 ) and the other not treated with a PZ enema ( n = 10 ) .
METHODS	All patients received usual induction therapy .
METHODS	Clinical symptoms , endoscopic findings and histological findings were evaluated at entry and one week later .
RESULTS	In the PZ group , modified Matts ' endoscopic scores were significantly improved after treatment compared to baseline in the rectum ( p = 0.004 ) , sigmoid colon ( p = 0.03 ) and descending colon ( p = 0.04 ) .
RESULTS	In the non-PZ group , scores were not significantly improved in the rectum ( p = 0.14 ) and descending colon ( p = 0.34 ) , but were improved in the sigmoid colon ( p = 0.04 ) .
RESULTS	In the PZ group , the Mayo scores at baseline and at Day 8 were 9.1 1.6 and 5.8 2.7 ( p = 0.00004 ) , respectively , and in the placebo group , the scores were 8.9 1.7 and 7.4 2.1 ( p = 0.009 ) , respectively .
RESULTS	Clinical response or remission was significantly better in the PZ group ( 71 % ) than in the placebo group ( 10 % ) .
CONCLUSIONS	A zinc-carnosine chelate compound , PZ , enema may become a useful new add-on treatment to accelerate mucosal healing in UC .

###25040429
BACKGROUND	Quantification of disease severity supports the development of evidence-based treatments .
BACKGROUND	Assessments to capture clinical improvement in hidradenitis suppurativa ( HS ) can be improved .
OBJECTIVE	This study aimed to validate the Hidradenitis Suppurativa Clinical Response ( HiSCR ) , which is defined as a 50 % reduction in inflammatory lesion count ( sum of abscesses and inflammatory nodules , AN ) , and no increase in abscesses or draining fistulas in HS when compared with baseline as a meaningful clinical endpoint for HS treatment .
METHODS	Patients with 3 ANs at baseline in a Phase II adalimumab trial for HS were included for analysis .
METHODS	HiSCR achievers vs. nonachievers were assessed at week 16 and week 52 .
METHODS	Criteria measures included physician-rated assessments [ Hurley stage , modified Sartorius score ( MSS ) , and HS Physician 's Global Assessment ] and patient-reported outcomes ( PROs : visual analogue pain scale , Dermatology Life Quality Index , and Work Productivity and Activity Impairment questionnaire ) .
METHODS	Test-retest reliability , convergent validity , responsiveness and predictive validity of HiSCR , and its meaningfulness to patients were assessed .
RESULTS	Among 138 eligible study participants , the majority were female ( 696 % ) with a mean age of 367 years .
RESULTS	The mean ( median ) MSS was 1252 ( 855 ) at baseline .
RESULTS	Test-retest reliability of the AN count was 091 .
RESULTS	HiSCR was significantly correlated with improvements in all physician-rated and PRO measures ( Spearman 's rho between -061 and -027 , all P < 0001 ) .
RESULTS	Improvements of all PROs in HiSCR achievers exceeded the respective meaningful improvement thresholds .
CONCLUSIONS	In patients with HS with 3 ANs , HiSCR achievers had significant improvements in physician-rated and patient-reported HS disease severity and impact .
CONCLUSIONS	HiSCR is a valid and meaningful endpoint for assessing HS treatment effectiveness in controlling inflammatory manifestations in this population .

###24985393
OBJECTIVE	To assess the efficacy of yoga for motor function , mental health , and quality of life outcomes in persons with chronic poststroke hemiparesis .
METHODS	Twenty-two individuals participated in a randomized controlled trial involving assessment of task-orientated function , balance , mobility , depression , anxiety , and quality of life domains before and after either a 10-week yoga intervention ( n = 11 ) or no treatment ( n = 11 ) .
RESULTS	The yoga intervention did not result in any significant improvements in objective motor function measures , however there was a significant improvement in quality of life associated with perceived motor function ( P = .0001 ) and improvements in perceived recovery approached significance ( P = .072 ) .
RESULTS	Memory-related quality of life scores significantly improved after yoga intervention ( P = .022 ) , and those participating in the intervention exhibited clinically relevant decreases in state and trait anxiety .
CONCLUSIONS	Preliminary results offer promise for yoga as an intervention to address mental health and quality of life in persons with stroke-related activity limitations .
CONCLUSIONS	There is a need to more rigorously evaluate these yoga benefits with a larger randomized controlled trial , which , based on this preliminary trial , is feasible .

###24513242
BACKGROUND	Ischemic mitral regurgitation ( IMR ) results from mitral leaflet tethering from left ventricular remodeling .
BACKGROUND	Heterogeneity in local or global left ventricular remodeling can result in differential tethering patterns and affect mitral valve function and the degree of mitral regurgitation .
BACKGROUND	The aims of this study were to compare mitral valve geometry in asymmetric and symmetric tethering patterns using three-dimensional transesophageal echocardiography and to examine the impact of tethering pattern on IMR severity .
METHODS	Sixty-two patients with moderate or greater IMR underwent three-dimensional transesophageal echocardiography for the assessment of mitral valve geometry .
METHODS	Symmetric and asymmetric tethering patterns were determined by mitral regurgitation jet direction and coaptation of the mitral leaflets .
METHODS	The ratio of posterior to anterior leaflet tethering angle was a measure of tethering pattern ( the higher the ratio , the more asymmetric the pattern ) .
METHODS	Overall tethering degree was assessed by tenting volume ( TV ) .
RESULTS	Compared with the symmetric group , the asymmetric group had less annular dilatation , greater annular heights ( 10.3 1.9 vs 8.5 1.9 mm , P < .01 ) , greater ratios of posterior to anterior leaflet tethering angle ( 3.19 0.88 vs 1.95 0.46 , P < .01 ) , and smaller TVs with more posterior displacement of the coaptation line .
RESULTS	Vena contracta normalized to TV was greater in the asymmetric group ( 0.38 0.24 vs 0.19 0.13 cm/mL , P < .01 ) .
RESULTS	Multivariate analysis showed that both ratio of posterior to anterior leaflet tethering angle ( = 0.46 , P < .001 ) and TV ( = 0.41 , P = .001 ) were predictors of IMR severity .
CONCLUSIONS	Differences in mitral valve geometry are observed between asymmetric and symmetric tethering patterns in IMR .
CONCLUSIONS	IMR degree is affected by both the pattern of tethering and the total degree of tethering .
CONCLUSIONS	For the same degree of tethering , an asymmetric pattern is associated with increased MR severity .
CONCLUSIONS	The pattern of mitral leaflet tethering may be considered in therapeutic decision making .

###25168927
BACKGROUND	Delirium is associated with substantial morbidity and mortality rates in elderly hospitalised patients , and a growing problem due to increase in life expectancy .
BACKGROUND	Implementation of standardised non-pharmacological delirium prevention strategies is challenging and adherence remains low .
BACKGROUND	Pharmacological delirium prevention with haloperidol , currently the drug of choice for delirium , seems promising .
BACKGROUND	However , the generalisability of randomised controlled trial results is questionable since studies have only been performed in selected postoperative hip-surgery and intensive care unit patient populations .
BACKGROUND	We therefore present the design of the multicenter , randomised , double-blind , placebo-controlled clinical trial on early pharmacological intervention to prevent delirium : haloperidol prophylaxis in older emergency department patients ( The HARPOON study ) .
METHODS	In six Dutch hospitals , at-risk patients aged 70 years or older acutely admitted through the emergency department for general medicine and surgical specialties are randomised ( n = 390 ) for treatment with prophylactic haloperidol 1 mg or placebo twice daily for a maximum of seven consecutive days .
METHODS	Primary outcome measure is the incidence of in-hospital delirium within seven days of start of the study intervention , diagnosed with the Confusion Assessment Method , and the Diagnostic and Statistical Manual of Mental Disorders , fourth edition criteria for delirium .
METHODS	Secondary outcome measures include delirium severity and duration assessed with the Delirium Rating Scale Revised 98 ; number of delirium-free days ; adverse events ; hospital length-of-stay ; all-cause mortality ; new institutionalisation ; ( Instrumental ) Activities of Daily Living assessed with the Katz Index of ADL , and Lawton IADL scale ; cognitive function assessed with the Six-item Cognitive Impairment Test , and the Dutch short form Informant Questionnaire on Cognitive Decline in the Elderly .
METHODS	Patients will be contacted by telephone three and six months post-discharge to collect data on cognitive - and physical function , home residency , all-cause hospital admissions , and all-cause mortality .
CONCLUSIONS	The HARPOON study will provide relevant information on the efficacy and safety of prophylactic haloperidol treatment for in-hospital delirium and its effects on relevant clinical outcomes in elderly at-risk medical and surgical patients .
BACKGROUND	EudraCT Number : 201100476215 ; ClinicalTrials.gov Identifier : NCT01530308 ; Dutch Clinical Trial Registry : NTR3207 .

###25800412
BACKGROUND	This study was designed to compare the performances of 4 airway devices in achieving successful ventilation .
METHODS	A randomized crossover trial was conducted to evaluate 4 airway devices : laryngeal mask airway ( LMA ) , i-gel ( iGEL ) , PENTAX Airway Scope ( AWS ) , and Macintosh laryngoscope ( MCL ) .
METHODS	Thirty-eight unskilled rescuers performed intubation on a manikin during chest compressions in normal and difficult airway scenarios .
METHODS	The time to ventilation , intubation success rate , and difficulty of intubation were measured .
RESULTS	The time to ventilation of the airway devices in the normal scenario had a median value of 8.8 seconds ( interquartile range , 7.3-10 .5 seconds ) for iGEL , 16.1 seconds ( 13.9-19 .3 seconds ) for LMA , 30.6 seconds ( 24.6-37 .6 seconds ) for AWS , and 35.0 seconds ( 29.5-45 .9 seconds ) for MCL .
RESULTS	In the difficult airway scenario , the respective time to ventilation was 8.6 seconds ( 7.8-10 .0 seconds ) , 15.3 seconds ( 14.3-20 .2 seconds ) , 29.4 seconds ( 25.7-36 .3 seconds ) and 59.0 seconds ( 46.1-103 .3 seconds ) .
RESULTS	The success rates were 100 % and 100 % for LMA , 100 % and 100 % for iGEL , 97.4 % and 94.7 % for AWS , and 78.9 % and 47.4 % for MCL in the normal and difficult airway scenarios .
RESULTS	The difficulties of intubation expressed as numerical rating scale were 2.0 and 2.0 ( median values ) for LMA , 1.0 and 2.0 for iGEL , 3.0 and 3.0 for AWS , and 4.0 and 5.0 for MCL in the normal and difficult airway scenarios , respectively .
CONCLUSIONS	With novice intubators who were unfamiliar with the airway devices , the LMA , iGEL , and AWS were superior to the MCL for establishing an airway without interruption of chest compressions in a manikin study .
CONCLUSIONS	Intubation with the iGEL was faster and easier than with the other airway devices .

###25872934
BACKGROUND	Myeloablative allogeneic haematopoietic stem cell transplantation ( allo-HSCT ) is a major procedure usually accompanied by multifactorial malnutrition , prompting the recommendation of systematic artificial nutritional support .
BACKGROUND	Parenteral nutrition ( PN ) is usually administered during allo-HSCT , essentially for practical reasons .
BACKGROUND	Recently published data suggest that enteral nutrition ( EN ) , given as systematic artificial nutrition support , could decrease grade III-IV graft-versus-host disease ( GVHD ) and infectious events , which are associated with early toxicity after allo-HSCT and then have an impact on early transplant-related mortality ( D100 mortality ) .
METHODS	We report on the NEPHA trial : an open-label , prospective , randomised , multi-centre study on two parallel groups , which has been designed to evaluate the effect of EN compared to PN on early toxicity after an allo-HSCT procedure .
METHODS	Two hundred forty patients treated with allo-HSCT for a haematological malignancy will be randomly assigned to two groups to receive either EN or PN .
METHODS	The primary endpoint will assess the effect of EN on D100 mortality .
METHODS	Secondary endpoints will compare EN and PN with regards to the main haematological , infectious and nutritional outcomes .
CONCLUSIONS	The impacts of nutritional support should exceed the limits of nutritional status improvement : EN may directly reduce immunological and infectious events , as well as decrease early transplant-related morbidity and mortality .
CONCLUSIONS	EN and PN need to be prospectively compared in order to assess their impacts and to provide treatment guidelines .
CONCLUSIONS	( Clinical trials gov number : NCT01955772 ; registration : July 19th , 2013 ) .

###26135349
BACKGROUND	Butter is known to have a cholesterol-raising effect and , therefore , has often been included as a negative control in dietary studies , whereas the effect of moderate butter intake has not been elucidated to our knowledge .
OBJECTIVE	We compared the effects of moderate butter intake , moderate olive oil intake , and a habitual diet on blood lipids , high-sensitivity C-reactive protein ( hsCRP ) , glucose , and insulin .
METHODS	The study was a controlled , double-blinded , randomized 2 5-wk crossover dietary intervention study with a 14-d run-in period during which subjects consumed their habitual diets .
METHODS	The study included 47 healthy men and women ( mean SD total cholesterol : 5.22 0.90 mmol/L ) who substituted a part of their habitual diets with 4.5 % of energy from butter or refined olive oil .
RESULTS	Study subjects were 70 % women with a mean age and body mass index ( in kg/m ) of 40.4 y and 23.5 , respectively .
RESULTS	Butter intake increased total cholesterol and LDL cholesterol more than did olive oil intake ( P < 0.05 ) and the run-in period ( P < 0.005 and P < 0.05 , respectively ) and increased HDL cholesterol compared with the run-in period ( P < 0.05 ) .
RESULTS	No difference in effects was observed for triacylglycerol , hsCRP , insulin , and glucose concentrations .
RESULTS	The intake of saturated fatty acids was significantly higher in the butter period than in the olive oil and run-in periods ( P < 0.0001 ) .
CONCLUSIONS	Moderate intake of butter resulted in increases in total cholesterol and LDL cholesterol compared with the effects of olive oil intake and a habitual diet ( run-in period ) .
CONCLUSIONS	Furthermore , moderate butter intake was also followed by an increase in HDL cholesterol compared with the habitual diet .
CONCLUSIONS	We conclude that hypercholesterolemic people should keep their consumption of butter to a minimum , whereas moderate butter intake may be considered part of the diet in the normocholesterolemic population .

###25329141
OBJECTIVE	Myofascial trigger points ( MTrPs ) are focal disruptions in the skeletal muscle that can refer pain to the head and reproduce the pain patterns of tension-type HA ( TTH ) .
OBJECTIVE	The present study applied massage focused on MTrPs of patients with TTH in a placebo-controlled , clinical trial to assess efficacy on reducing headache ( HA ) pain .
METHODS	Fifty-six patients with TTH were randomized to receive 12 massage or placebo ( detuned ultrasound ) sessions over 6 weeks , or to wait-list .
METHODS	Trigger point release massage focused on MTrPs in cervical musculature .
METHODS	HA pain ( frequency , intensity , and duration ) was recorded in a daily HA diary .
METHODS	Additional outcome measures included self-report of perceived clinical change in HA pain and pressure-pain threshold at MTrPs in the upper trapezius and suboccipital muscles .
RESULTS	From diary recordings , group differences across time were detected in HA frequency ( P = 0.026 ) , but not for intensity or duration .
RESULTS	Post hoc analysis indicated that HA frequency decreased from baseline for both massage ( P < 0.0003 ) and placebo ( P = 0.013 ) , but no difference was detected between massage and placebo .
RESULTS	Patient report of perceived clinical change was greater reduction in HA pain for massage than placebo or wait-list groups ( P = 0.002 ) .
RESULTS	Pressure-pain threshold improved in all muscles tested for massage only ( all P 's < 0.002 ) .
CONCLUSIONS	Two findings from this study are apparent : ( 1 ) MTrPs are important components in the treatment of TTH , and ( 2 ) TTH , like other chronic conditions , is responsive to placebo .
CONCLUSIONS	Clinical trials on HA that do not include a placebo group are at risk for overestimating the specific contribution from the active intervention .

###25039272
OBJECTIVE	To evaluate the efficacy and safety of combination therapy of sildenafil plus vacuum erection devices in men with type 2 diabetes mellitus with moderate to severe erectile dysfunction who are dissatisfied with the results of using sildenafil alone .
METHODS	The study included 66 diabetes mellitus patients presenting erectile dysfunction for at least 6 months and dissatisfied with the use of 100 mg sildenafil monotherapy .
METHODS	The patients were randomized in two groups .
METHODS	Those in group A ( n = 33 ) were instructed to use a vacuum erection device only , whereas those in group B ( n = 33 ) were treated with combination therapy , including sildenafil 100 mg and a vacuum erection device .
METHODS	Erectile function was evaluated subjectively using the International Index of Erectile Function , Sexual Encounter Profile questionnaire questions 2 and 3 at visit 1 ( baseline ; study entry ) , visit 2 ( 4 weeks after baseline ) , and visit 3 ( 12 weeks after baseline ; study end ) .
RESULTS	There were no significant differences in average patient age , duration of diabetes , duration of erectile dysfunction , baseline International Index of Erectile Function scores , hypertension , blood testosterone , smoking and alcohol consumption between two groups .
RESULTS	Mean International Index of Erectile Function scores were significantly higher for group B at the 1-month ( 14.86 2.17 vs 12.41 2.63 ; P < 0.0001 ) and 3-months ( 17.53 2.95 vs 14.29 2.81 ; P < 0.0001 ) visits .
RESULTS	Men in group B had better successful penetration ( 73.3 % vs 46.6 % ) and successful intercourse ( 70 % vs 46.6 % ) at 3 months compared with group A.
CONCLUSIONS	Combined use of sildenafil and vacuum erection device therapy significantly enhances erectile function , and it is well tolerated by diabetes mellitus patients not responding to first-line sildenafil alone .

###25910787
OBJECTIVE	Direct health provider to patient presentation of coronary computed tomography angiography findings may increase adherence to preventive therapy and risk modification .
OBJECTIVE	The purpose of this study was to assess the influence of visualization of coronary artery calcification and lifestyle recommendations on cholesterol concentrations and other risk variables in symptomatic patients with nonobstructive coronary artery disease and hyperlipidemia .
METHODS	We performed a prospective 2-center randomized controlled trial .
METHODS	Patients were randomized 1:1 to intervention or standard follow-up in general practice .
METHODS	The primary end point was change in plasma total cholesterol concentration at 6 months follow-up .
RESULTS	We included 189 patients ( mean [ standard deviation ] age 61 [ 12 ] years , 57 % were male ) .
RESULTS	Median ( range ) Agatston score was 166 ( 70-2054 ) .
RESULTS	The reduction in plasma total cholesterol concentrations tended to be higher in the intervention group than in the control group , 51.04 mg/dL versus 45.63 mg/dL ( P = .181 ) .
RESULTS	In a subgroup including patients continuing statin therapy during follow-up ( n = 147 ) , the reduction in plasma total cholesterol concentrations was more pronounced in the intervention group than in the control group , 66.13 mg/dL versus 55.68 mg/dL ( P = .027 ) .
RESULTS	In the intervention group , there was a higher degree of statin adherence and a higher proportion of patients who stopped smoking and commenced healthier dietary behavior than in the control group .
CONCLUSIONS	Visualization of coronary artery calcification and brief recommendations about risk modification after coronary computed tomography angiography in symptomatic patients with nonobstructive coronary artery disease and hyperlipidemia may have a favorable influence on plasma total cholesterol concentration , adherence to statin therapy , and risk behavior .
CONCLUSIONS	Further investigations are needed .

###25098068
BACKGROUND	Inguinal hernia is the commonest type of external hernias .
BACKGROUND	Lichtenstein mesh repair is the most favoured technique of inguinal hernia repair nowadays .
BACKGROUND	It is tension free repair of weakened inguinal wall using polypropylene mesh .
BACKGROUND	The present study was conducted to determine the efficacy of single dose antibiotic with placebo on patients undergoing inguinal hernia mesh repair .
METHODS	This randomised controlled trial was carried out in the Department of General Surgery , Ayub Teaching Hospital , Abbottabad from January to December 2011 .
METHODS	The study population included male patients presenting with primary unilateral inguinal hernia , above 18 years of age .
METHODS	Mesh repair was performed in all patients .
METHODS	The patients were randomly divided into two groups .
METHODS	Patients in group A were given a single dose of antibiotic before inguinal hernia mesh repair and patients in group B were given placebo before inguinal hernia mesh repair .
METHODS	Efficacy of antibiotic and placebo was accessed in terms of surgical site infections ( SSIs ) .
RESULTS	A total of 166 cases of inguinal hernia mesh repair patients were recorded during the study period .
RESULTS	A total of 83 patients were recruited in each group .
RESULTS	Surgical site infection was found in 6 ( 7.2 % ) in Group B it was 15 ( 18.1 % ) .
RESULTS	The difference being statistically significant ( p = 0.036 ) .
CONCLUSIONS	Antibiotic prophylaxis is a preferred option for mesh plasty .

###24811759
OBJECTIVE	The purpose of this parallel randomised controlled trial was to compare compliance with different modalities used to invite patients with a positive immunochemical faecal occult blood test ( FIT + ) for a total colonoscopy ( TC ) .
METHODS	FIT + patients from nine Italian colorectal cancer screening programmes were randomised to be invited for a TC initially by mail or by phone and , for non-compliers , to be recalled by mail , for counselling with a general practitioner , or to meet with a specialist screening practitioner ( nurse or healthcare assistant ) .
RESULTS	In all , 3777 patients were randomised to different invitation strategies .
RESULTS	Compliance with an initial invitation by mail and by phone was similar ( 86.0 % vs. 84.0 % , relative risk - RR : 1.02 ; 95 % CI 0.97-1 .08 ) .
RESULTS	Among non-responders to the initial invitation , compliance with a recall by appointment with a specialist practitioner was 50.4 % , significantly higher than with a mail recall ( 38.1 % ; RR :1.33 ; 95 % CI 1.01-1 .76 ) or with a face-to-face counselling with the GP ( 30.8 % ; RR :1.45 ; 95 % CI 1.14-1 .87 ) .
CONCLUSIONS	Compliance with an initial invitation for a TC by mail and by phone was similar .
CONCLUSIONS	A personal meeting with a specialist screening practitioner was associated with the highest compliance among non-compliers with initial invitations , while the involvement of GPs in this particular activity seemed less effective .

###24984991
OBJECTIVE	The aim of this study was to determine the effect of combined calcium and iron versus single iron supplementation on iron status in Bolivian schoolchildren .
METHODS	Children ages 6 to 10 y old ( N = 195 ) , were randomly assigned to receive either 700 mg Ca ( as calcium carbonate ) plus 30 mg Fe ( as ferrous sulfate ) ( Ca + Fe group ) or 30 mg Fe ( as ferrous sulfate ) ( Fe group ) .
METHODS	The doses were administered daily , from Monday to Friday , between meals at school over 3 mo. .
METHODS	Iron status was assessed at baseline and after intervention .
METHODS	Additionally , overall nutritional status was assessed by anthropometry and an estimation of dietary intake .
RESULTS	At baseline , the prevalence of anemia in the Ca + Fe group and the Fe group were 15 % and 21.5 % , respectively .
RESULTS	After 3 mo follow-up , the prevalence of iron deficiency anemia dropped significantly ( P < 0.001 ) to 3 % in both groups ( ( 2 ) = NS ) .
RESULTS	Iron dietary intake was within recommended levels , but calcium intake only covered 39 % of the Recommended Daily Intake .
CONCLUSIONS	Combined calcium and iron supplementation is equally as effective as single iron supplementation in reducing the prevalence of iron deficiency anemia in Bolivian school children .

###24604348
OBJECTIVE	The efficacy and safety of primary intraocular lens ( IOL ) implantation during early infancy is unknown .
OBJECTIVE	To compare the visual outcomes of patients optically corrected with contact lenses vs IOLs following unilateral cataract surgery during early infancy .
METHODS	The Infant Aphakia Treatment Study is a randomized clinical trial with 5 years of follow-up that involved 114 infants with unilateral congenital cataracts at 12 sites .
METHODS	A traveling examiner assessed visual acuity at age 4.5 years .
METHODS	Cataract surgery with or without primary IOL implantation .
METHODS	Contact lenses were used to correct aphakia in patients who did not receive IOLs .
METHODS	Treatment was determined through random assignment .
METHODS	HOTV optotype visual acuity at 4.5 years of age .
RESULTS	The median logMAR visual acuity was not significantly different between the treated eyes in the 2 treatment groups ( both , 0.90 [ 20/159 ] ; P = .54 ) .
RESULTS	About 50 % of treated eyes in both groups had visual acuity less than or equal to 20/200 .
RESULTS	Significantly more patients in the IOL group had at least 1 adverse event after cataract surgery ( contact lens , 56 % ; IOL , 81 % ; P = .02 ) .
RESULTS	The most common adverse events in the IOL group were lens reproliferation into the visual axis , pupillary membranes , and corectopia .
RESULTS	Glaucoma/glaucoma suspect occurred in 35 % of treated eyes in the contact lens group vs 28 % of eyes in the IOL group ( P = .55 ) .
RESULTS	Since the initial cataract surgery , significantly more patients in the IOL group have had at least 1 additional intraocular surgery ( contact lens , 21 % ; IOL , 72 % ; P < .001 ) .
CONCLUSIONS	There was no significant difference between the median visual acuity of operated eyes in children who underwent primary IOL implantation and those left aphakic .
CONCLUSIONS	However , there were significantly more adverse events and additional intraoperative procedures in the IOL group .
CONCLUSIONS	When operating on an infant younger than 7 months of age with a unilateral cataract , we recommend leaving the eye aphakic and focusing the eye with a contact lens .
CONCLUSIONS	Primary IOL implantation should be reserved for those infants where , in the opinion of the surgeon , the cost and handling of a contact lens would be so burdensome as to result in significant periods of uncorrected aphakia .
BACKGROUND	clinicaltrials.gov Identifier : NCT00212134

###25263254
BACKGROUND	In the majority of cases , trigeminal neuralgia ( TN ) is a unilateral condition with ultra-short stabbing pain located along one or more branches of the trigeminal nerve .
BACKGROUND	Although prophylactic pharmacological treatment is first choise , considering of insufficient effect or unacceptable side effects , neurosurgical treatment or lesion treatment should be considered .
BACKGROUND	In addition to all these procedures mentioned above , one approach has been based on local intradermal and/or submucosal injections of Botulinum Toxin Type A ( BTX-A ) .
METHODS	We conducted a randomized , double-blind , placebo-controlled since November 2012 , and adopted local multi-point injection in 84 cases of classical TN with different doses of BTX-A .
METHODS	Eighty four patients were randomized into following groups : placebo ( n = 28 ) ; BTX-A 25U ( n = 27 ) ; BTX-A 75U ( n = 29 ) .
METHODS	Follow-up visits were conducted every week after the injection , and the overall duration of the study for each patient were 8weeks to observe the pain severity , efficacy and adverse reactions at endpoint .
RESULTS	The visual analogue scale ( VAS ) scores of 25U and 75U groups reduced significantly compared to placebo as early as week 1 , and sustained until week 8 throughout the study .
RESULTS	There was no significant difference in VAS between 25U and 75U groups throughout the study .
RESULTS	The response rates of 25U group ( 70.4 % ) and 75U group ( 86.2 % ) were significantly higher than placebo group ( 32.1 % ) at week 8 , and there was no significant difference between 25U and 75U groups .
RESULTS	Evaluation of the Patient Global Impression of Change ( PGIC ) demonstrated that 66.7 % ( 25U group ) and 75.9 % ( 75U group ) of the patients reported that their pain symptoms were ` much improved ' or ` very much improved ' versus 32.1 % of the placebo group , and there was also no significant difference between 25U and 75U groups .
RESULTS	All adverse reactions were graded as mild or moderate .
CONCLUSIONS	BTX-A injection in TN is safe and efficient .
CONCLUSIONS	It is a useful treatment for refractory TN .
CONCLUSIONS	Lower dose ( 25U ) and high dose ( 75U ) were similar in efficacy in short-term .

###26016365
OBJECTIVE	This study was aimed to explore the physiological changes and the effect of heat acclimation training via a randomized control trial study .
METHODS	Forty healthy male volunteers were chosen and divided into experimental group and control group randomly .
METHODS	Those in experimental group received heat acclimation training including but not limited to meditation , unarmed run , yoga , and stepping in hot lab environment .
METHODS	And then , subjective feeling , rectal temperature , average skin temperature , and sweat electrolytes concentration were detected in order to describe their physiological changes .
METHODS	Before and after the training , both groups received some tests and their 3 000 m run-race time , nervous reaction time and subjective perception scores were recorded to evaluate the effect of acclimation training .
RESULTS	( 1 ) There was no difference in 3 000 m between the 2 groups in the same environment .
RESULTS	Subjects ' 3 000 m race time in experimental group was obviously shortened than that in control group in room temperature environment ( t = 2.326 , P < 0.05 ) .
RESULTS	And subjects ' 3 000 m race time in experimental group was obviously shortened than that in control group in hot-humid environment ( t = 4.518 , P < 0.01 ) .
RESULTS	( 2 ) Subjects ' reaction time ( RT ) in experimental group was shortened than that in control group in room temperature environment ( Z = 11.258 , P < 0.05 ) .
RESULTS	And Subjects ' RT in experimental group was sharply shortened than that in control group in hot-humid environment ( Z = 6.519 , P < 0.01 ) .
RESULTS	( 3 ) No difference between the experimental and control groups was observed in subjective perception score ( SPS ) in room temperature environment .
RESULTS	But subjects ' SPS in experimental group was obviously lowered than that in control group and in hot-humid environment ( t = 17.958 , P < 0.01 ) .
RESULTS	( 4 ) Anal temperature ( AT ) was lowered during training , while the change of mean skin temperature ( MST ) was not significant .
RESULTS	Sweat sodium concentration ( SSC ) was lowered during training .
RESULTS	SPS continued to decrease and entered plateau on the 13th day after training .
RESULTS	( 5 ) After acclimation training , the working capacity of the experimental group in hot-humid environment was over 85 % of that in room temperature environment .
RESULTS	While subjects ' working capacity in control group in hot-humid environment was about 80 % of that in room temperature environment .
CONCLUSIONS	Hot-humid environment acclimation training improved the working capacity .
CONCLUSIONS	After training , subjects ' working capacity in hot-humid environment remained over 85 % of that in room temperature environment , which was higher than that of those subjects who did not take part in training .

###24786192
OBJECTIVE	The mammalian skin is a barrier that effectively separates the water-rich interior of the body from the normally dryer exterior .
OBJECTIVE	Changes in the external conditions , for example ambient humidity , have been shown to affect the skin barrier properties .
OBJECTIVE	The prime objective of this study was to evaluate the effect of water activity of a topical formulation on skin hydration and permeability .
OBJECTIVE	A second objective was to gain more understanding on how two commonly used humectants , urea and glycerol , affect skin barrier function in vivo .
METHODS	Simple aqueous formulations were applied under occlusion to the volar forearm of healthy volunteers .
METHODS	Following 4-h exposure , skin water loss ( by transepidermal water loss measurements ) , skin hydration ( by Corneometry ) and skin permeability ( by time to vasodilation due to benzyl nicotinate exposure ) were monitored .
RESULTS	The results demonstrate that a relatively small change in the water activity of a topical formulation is sufficient to induce considerable effects on stratum corneum hydration and permeability to exogenous substances .
RESULTS	Exposing the skin to high water activity leads to increased skin hydration and also increased permeability .
RESULTS	Furthermore , urea and glycerol promote skin hydration and permeability even at reduced water activity of the applied formulation .
CONCLUSIONS	These results highlight the importance of considering the water activity in topically applied formulations and the potential benefit of using humectants .
CONCLUSIONS	The results may impact formulation optimization in how to facilitate skin hydration and to modify skin permeability by temporarily open and close the skin barrier .

###25099533
BACKGROUND	Internet - and mobile based stress-management interventions ( iSMI ) may be an effective means to address the negative consequences of occupational stress .
BACKGROUND	However , available results from randomised controlled trials are conflicting .
BACKGROUND	Moreover , it is yet not clear whether guided or unguided self-help iSMI provide better value for money .
BACKGROUND	Internet-based mental health interventions without guidance are often much less effective than interventions including at least some guidance from a professional .
BACKGROUND	However , direct comparisons in randomised controlled trials are scarce and , to the best of our knowledge , the comparative ( cost ) - effectiveness of guided vs. unguided iSMI has not yet been studied .
BACKGROUND	Hence , this study investigates the acceptability and ( cost - ) effectiveness of minimal guided and unguided iSMI in employees with heightened levels of perceived stress .
METHODS	A three-armed randomised controlled trial ( RCT ) will be conducted to compare a minimal guided and unguided iSMI with a waiting list control condition ( WLC ) .
METHODS	Both active conditions are based on the same iSMI , i.e. GET.ON Stress , and differ only with regard to the guidance format .
METHODS	Employees with heightened levels of perceived stress ( PSS 22 ) will be randomised to one of three conditions .
METHODS	Primary outcome will be comparative changes in perceived stress ( PSS ) .
METHODS	Secondary outcomes include changes in self-reported depression , work-engagement , presenteeism and absenteeism .
METHODS	Moreover , a cost-effectiveness analysis will be conducted from a societal perspective , including both direct medical costs and costs related to productivity losses .
METHODS	In addition , a cost-benefit analysis will be conducted from the employer 's perspective .
METHODS	Incremental net-benefit regression analyses will address the question if there are any baseline factors ( i.e. subgroups of employees ) associated with particularly favorable cost-effectiveness when the experimental intervention is offered .
METHODS	Assessments take place at baseline , 7 weeks post-treatment and 6 months after randomisation .
CONCLUSIONS	Online-based ( guided ) self-help interventions could be an acceptable , effective and economically sustainable approach to offer evidence-based intervention alternatives to reduce the negative consequences associated with work-related stress .
CONCLUSIONS	This study evaluates the ( cost - ) effectiveness of two versions of an iSMI , minimal guided and unguided iSMI .
CONCLUSIONS	Thus , the present study will further enhance the evidence-base for iSMI and provide valuable information about the optimal balance between outcome and economic costs .
BACKGROUND	German Clinical Trial Registration ( DRKS ) : DRKS00005687 .

###26075655
OBJECTIVE	The aim of this study was to examine the putative adverse effects of ambient fine particulate matter ( PM2 .5 : PM with aerodynamic diameters < 2.5 m ) on brain volumes in older women .
METHODS	We conducted a prospective study of 1,403 community-dwelling older women without dementia enrolled in the Women 's Health Initiative Memory Study , 1996-1998 .
METHODS	Structural brain magnetic resonance imaging scans were performed at the age of 71-89 years in 2005-2006 to obtain volumetric measures of gray matter ( GM ) and normal-appearing white matter ( WM ) .
METHODS	Given residential histories and air monitoring data , we used a spatiotemporal model to estimate cumulative PM2 .5 exposure in 1999-2006 .
METHODS	Multiple linear regression was employed to evaluate the associations between PM2 .5 and brain volumes , adjusting for intracranial volumes and potential confounders .
RESULTS	Older women with greater PM2 .5 exposures had significantly smaller WM , but not GM , volumes , independent of geographical region , demographics , socioeconomic status , lifestyles , and clinical characteristics , including cardiovascular risk factors .
RESULTS	For each interquartile increment ( 3.49 g/m ( 3 ) ) of cumulative PM2 .5 exposure , the average WM volume ( WMV ; 95 % confidence interval ) was 6.23 cm ( 3 ) ( 3.72-8 .74 ) smaller in the total brain and 4.47 cm ( 3 ) ( 2.27-6 .67 ) lower in the association areas , equivalent to 1 to 2 years of brain aging .
RESULTS	The adverse PM2 .5 effects on smaller WMVs were present in frontal and temporal lobes and corpus callosum ( all p values < 0.01 ) .
RESULTS	Hippocampal volumes did not differ by PM2 .5 exposure .
CONCLUSIONS	PM2 .5 exposure may contribute to WM loss in older women .
CONCLUSIONS	Future studies are needed to determine whether exposures result in myelination disturbance , disruption of axonal integrity , damages to oligodendrocytes , or other WM neuropathologies .

###25077910
METHODS	A randomized , controlled clinical trial .
OBJECTIVE	This randomized controlled clinical trial was aimed at comparing the clinical outcomes of combined posteroanterior ( P-A ) fusion and transforaminal thoracic interbody fusion ( TTIF ) in cases of thoracolumbar fracture-dislocation .
BACKGROUND	The optimal treatment strategy for thoracolumbar fracture-dislocation remains controversial .
METHODS	Sixty-one patients presenting with acute fracture-dislocation of the thoracolumbar joint between March 2010 and December 2011 were enrolled and randomly assigned to the P-A or TTIF group .
METHODS	The radiological outcome was assessed by acquiring radiographs in the standing position and computed tomographic scans .
METHODS	The clinical outcome was measured in terms of the American Spinal Injury Association score , visual analogue scale score , and Oswestry Disability Index .
METHODS	Moreover , we assessed the severity of overall morbidity and morbidity at the donor site in the 2 patient groups .
METHODS	The Student t and tests were used for the analysis of independent variables and categorical data , respectively .
RESULTS	Only 57 of the enrolled patients were available for the required 24-month follow-up period , 27 underwent TTIF and 30 underwent P-A fusion .
RESULTS	Both treatments were similar with respect to the fusion rate , extent of decompression , loss of correction , rate of instrumentation failure , American Spinal Injury Association score , visual analogue scale score , and Oswestry Disability Index ( P > 0.05 ) .
RESULTS	However , the blood loss , operating time , and rate of perioperative complications were greater in the P-A group than in the TTIF group ( P < 0.05 ) .
CONCLUSIONS	The clinical and radiological outcomes were similar for both the treatment procedures .
CONCLUSIONS	However , our findings suggest that TTIF allows for safe interbody fusion and circumferential decompression , requires only a posterior approach , and is associated with a lower incidence of surgery-related complications .
METHODS	2 .

###24377211
OBJECTIVE	To evaluate the follow-up efficacy and safety on slow transit constipation ( STC ) treated with individualized deep puncture at Tianshu ( ST 25 ) .
METHODS	One hundred and twenty-eight cases of STC were randomized into a deep puncture group ( 64 cases ) , a western medication group ( 31 cases ) and a shallow puncture group ( 33 cases ) at the ratio of 2:1:1 .
METHODS	In the deep puncture group , electroacupuncture of deep puncture was applied to bilateral Tianshu ( ST 25 ) .
METHODS	The needle was inserted perpendicularly and slowly at the acupoint and went deeply till penetrating the peritoneum , about 20 to 65 mm in depth .
METHODS	In the western medication group , lactulose oral liquid was prescribed for oral administration .
METHODS	In the shallow puncture group , electroacupuncture of shallow puncture was done at bilateral Tianshu ( ST 25 ) .
METHODS	The needle was inserted perpendicularly and slowly , 5 to 8 mm in depth .
METHODS	The treatment lasted 4 weeks in the three groups and the follow-up visit of 12 weeks and 6 month after treatment was performed respectively .
METHODS	The weekly defecation frequency , patient 's satisfaction and safety of deep puncture at Tianshu ( ST 25 ) were assessed before and after treatment in each group .
RESULTS	In the deep puncture group , the weekly defecation frequency was ( 1.79 + / - 1.05 ) times/week before treatment and was ( 3.90 + / - 1.43 ) times/week after 4-week treatment .
RESULTS	It was ( 3.49 + / - 1.46 ) times/week in 12-week follow-up visit after treatment and was ( 3.51 + / - 1.42 ) times/week in 6-month follow-up visit after treatment .
RESULTS	In the deep puncture group , the improvements in weekly defecation frequency , patient 's satisfaction and short-term efficacy were same as those in the western medication group and the shallow puncture group ( all P > 0.05 ) .
RESULTS	The long-term efficacy in follow-up visit was better remarkably than that in the western medication group ( P < 0.05 , P < 0.01 ) .
RESULTS	Besides , the combined medication was reduced and no adverse reaction occurred .
CONCLUSIONS	The individualized deep puncture at Tianshu ( ST 25 ) is effective in the treatment of STC and achieves the satisfactory long-term efficacy .
CONCLUSIONS	This therapy displays the good effective advantage and deserves to be promoted in clinical practice of acupuncture and moxibustion therapeutic program as compared with the first-tier line of medication , lactulose oral liquid , recommended at home and abroad , in terms of the evidence-based medicine .

###24917487
OBJECTIVE	Participant retention is an important challenge in longitudinal research on homeless people .
OBJECTIVE	High attrition can threaten validity , and may represent lost opportunities to deliver interventions .
OBJECTIVE	In this article , we report on attrition in the At Home/Chez Soi study , a multi-site randomized controlled trial of a housing intervention for homeless people with mental illness .
METHODS	We first calculate life tables , and then use clustered logistic regression to implement a discrete-time survival model .
METHODS	We use splines and indicator variables to capture non-linear and group-specific variation over time in the hazard function .
METHODS	As potential predictors , we consider study group , site , date of recruitment , age , sex , baseline substance dependence , baseline psychotic disorder , time homeless in life , community functioning , and education .
RESULTS	The study recruited 2,148 homeless people with mental illness .
RESULTS	Of these , 1,158 were randomized to the housing first intervention ( HF ) , and 990 to treatment as usual ( TAU ) .
RESULTS	Excluding 79 people known to have died , attrition was 14 % .
RESULTS	This proportion was higher in TAU than in HF ( 21 vs. 8 % , p < 0.01 ) .
RESULTS	Attrition was significantly lower in one site than elsewhere , and was also lower among those with substance dependence ( 13 vs. 18 % , p < 0.01 ) and among those enrolled earlier in the study .
RESULTS	The hazard varied over time in complex ways .
CONCLUSIONS	Results imply that study factors are more important than participant characteristics as determinants of retention , and that the immediate period after randomization is a crucial one .
CONCLUSIONS	The high overall retention demonstrates the effectiveness of existing techniques for retaining participants .

###25288473
BACKGROUND	The main objective of the present work was to compare the effects of the gonadotropin-releasing hormone agonist ( GnRH-a ) and GnRH antagonist ( GnRH-ant ) on the gene expression profiles of oocytes obtained from Iranian infertile couples undergoing in vitro fertilization ( IVF ) .
METHODS	Fifty infertile couples who underwent IVF between June 2012 and November 2013 at the Infertility Center of Tehran Women General Hospital , Tehran University of Medical Sciences , were included in this study .
METHODS	We included women that had undergone IVF treatment because of male factor , tubal factor , or unexplained infertility .
METHODS	The women randomly underwent controlled ovarian stimulation ( COS ) with either the GnRH-a ( n = 26 ) or the GnRH-ant ( n = 24 ) .
METHODS	We obtained 50 germinal vesicle ( GV ) oocytes donated by women in each group .
METHODS	After the sampling , pool of 50 GV oocytes for each group was separately analyzed by quantitative polymerase chain reaction ( qPCR ) .
RESULTS	The expression levels of Adenosine triphosphatase 6 ( ATPase 6 ) , Bone morphogenetic protein 15 ( BMP15 ) , and Neuronal apoptosis inhibitory protein ( NAIP ) genes were significantly upregulated in the GnRH-ant group compared to the GnRH-a group , with the fold change of 3.990 ( SD 1.325 ) , 6.274 ( SD 1.542 ) , and 2.156 ( SD 1.443 ) , respectively , ( P < 0.001 ) .
RESULTS	Growth differentiation factor 9 ( GDF9 ) mRNA did not have any expression in the GnRH-a group ; however , GDF9 mRNA was expressed in the GnRH-ant group .
RESULTS	Finally , it was found that the genes involved in the DNA repairing and cell cycle checkpoint did not have any expression in either group .
CONCLUSIONS	The present study showed , for the first time , the expression levels of genes involved in the cytoplasmic maturity ( BMP15 , GDF9 ) , adenosine triphosphate production ( ATPase 6 ) , and antiapoptotic process ( NAIP ) , in human GV oocytes were significantly higher in the GnRH-anta group than in the GnRH-a group in COS. .
CONCLUSIONS	Higher expression level of these genes when GnRH-ant protocol is applied , this protocol seems to be a more appropriate choice for women with poly cystic ovarian syndrome , because it can probably improve the expression of the aforementioned genes .
BACKGROUND	Current Controlled Trials : IRCT 2014031112307 N3 .

###24251833
BACKGROUND	Botulinum toxin type A ( BTX-A ) has been reported to have analgesic effects independent of its action on muscle tone , mostly by acting on neurogenic inflammatory mediators and controlling the neurotransmitter release of sensory and autonomic nerve terminals that are involved in many chronic painful conditions as chronic intractable trigeminal neuralgia ( TN ) .
BACKGROUND	The aim of our work was evaluating the efficacy , safety , and tolerability of BTX-A for the treatment of intractable idiopathic TN .
METHODS	This was a randomized , single-blinded , placebo-control study carried out on 20 Egyptian patients with intractable TN .
METHODS	Patients received a one-time subcutaneous administration of BTX-A using `` follow the pain '' method .
METHODS	The primary efficacy measure was reduction in pain severity on the 10-cm VAS score as well as in paroxysms frequency from the baseline to week 12 ( endpoint last observation carried forward [ LOCF ] ) .
METHODS	Secondary efficacy measures included QoL assessment and number of acute medications received from baseline to the endpoint .
RESULTS	Pain reduction at the 12-week endpoint was significant in BTX-A group ( p < 0.0001 ) ; VAS scores at endpoint LOCF relative to baseline for BTX-A group showed a decrease of 6.5 compared with a decrease of 0.3 for placebo , also there was a significant decrease in the number of acute medications and an increase in QoL functioning scale .
CONCLUSIONS	These results indicate that BTX-A has a direct analgesic effect in patients with TN and can represent a therapeutic option for intractable cases .

###24565088
OBJECTIVE	Hydroxyethyl starch ( HES ) 130/0 .4 is considered an effective plasma expander when compared to crystalloids .
OBJECTIVE	There is controversy around its superiority regarding hemodynamic optimization and about possible detrimental effects on coagulation .
OBJECTIVE	The aim of this study was to compare the effects of HES 130/0 .4 to lactated Ringer solution during hip arthroplasty in adult patients under spinal anesthesia regarding intraoperative bleeding , hemodynamic parameters , coagulation profile , transfusion requirements and clinical outcomes .
METHODS	In this randomized , controlled trial , 48 patients scheduled for hip arthroplasty with spinal anesthesia were randomized into two groups : 24 patients were allocated to receive a preload of 15 mL.kg ( -1 ) of HES 130/0 .4 and 24 patients received a preload of 30 mL.kg ( -1 ) lactated Ringer solution before surgery .
METHODS	Hemodynamic measurements , hemoglobin concentrations , biochemical parameters and coagulation tests were evaluated in three periods during surgical procedure .
METHODS	Patients received medical follow-up during their hospital stay and up to postoperative 30 days .
METHODS	Primary outcome was the requirement of red blood cell transfusion between groups during hospital stay .
METHODS	Secondary outcome were hemodynamic parameters , length of hospital stay , mortality and occurrence of clinical postoperative complications .
RESULTS	Red blood cell transfusion was required in 17 % of patients in the HES group and in 46 % in the Ringer group ( p = .029 ) .
RESULTS	Postoperative infections were more frequently observed in the Ringer group ( 17 % ) compared to the HES group ( 0 ) , p = .037 .
RESULTS	There were no significant differences between groups in mortality , hospital length of stay and clinical complications other than infection .
CONCLUSIONS	During hip arthroplasty , patients treated with hypervolemic hemodilution with hydroxyethyl starch 130/0 .4 required less transfusion and presented lower infection rate compared to patients who received lactated Ringer .

###24330505
BACKGROUND	The use of ecstasy is a public health problem and is associated with a range of social costs and harms .
BACKGROUND	In recent years , there has been growing concern about the availability and misuse of new and emerging drugs designed to mimic the effects of illicit drugs , including ecstasy .
BACKGROUND	This , coupled with the fact that the age of use and the risk factors for using ecstasy and emerging drugs are similar , provides a compelling argument to implement prevention for these substances simultaneously .
BACKGROUND	The proposed study will evaluate whether a universal Internet-based prevention program , known as the Climate Schools : Ecstasy and Emerging Drugs Module , can address and prevent the use of ecstasy and emerging drugs among adolescents .
METHODS	A cluster randomised controlled trial will be conducted among Year 10 students ( aged 15-16 years ) from 12 secondary schools in Sydney , Australia .
METHODS	Schools will be randomly assigned to either the Climate Schools intervention group or the control group .
METHODS	All students will complete a self-report questionnaire at baseline , immediately post-intervention , and 6 - , 12 - and 24-months post-baseline .
METHODS	The primary outcome measures will include ecstasy and emerging drug-related knowledge , intentions to use these substances in the future , and the patterns of use of ecstasy and emerging drugs .
METHODS	A range of secondary outcomes will also be assessed , including beliefs and attitudes about ecstasy and emerging drugs , peer pressure resistance , other substance use and mental health outcomes .
CONCLUSIONS	To our knowledge , this will be the first evaluation of an Internet-based program designed to specifically target ecstasy and NED use among adolescents .
CONCLUSIONS	If deemed effective , the Climate Schools : Ecstasy and Emerging Drugs Module will provide schools with an interactive and novel prevention program for ecstasy and emerging drugs that can be readily implemented by teachers .
BACKGROUND	This trial is registered with the Australian New Zealand Clinical Trials Registry , ACTRN12613000708752 .

###24576202
OBJECTIVE	To assess the effect of systematic local infiltration analgesia on postoperative pain in vaginal hysterectomy , and describe the technique in detail .
METHODS	A randomized , double-blind , placebo-controlled study following the CONSORT criteria .
METHODS	A university hospital .
METHODS	Thirty-seven patients undergoing vaginal hysterectomy .
METHODS	Patients received high-volume ( 50mL ) ropivacaine 0.50 % ( n = 20 ) or saline ( n = 17 ) infiltration using a systematic technique ensuring uniform delivery to all tissues incised , handled or instrumented during the procedure .
METHODS	Pain , nausea , vomiting and opioid requirements were assessed for 32 h as well as time spent in the post-anesthesia care unit and time to first mobilization .
RESULTS	Pain at rest was significantly reduced after one , four and eight hours in the ropivacaine group ( p0.001-0 .01 ) .
RESULTS	Pain during coughing was significantly reduced after one and four hours ( p0 .001 and p0 .003 ) , and pain during movement was significantly reduced after four hours ( p0 .02 ) .
RESULTS	Opioid requirements and time spent in the post-anesthesia care unit were significantly reduced in the ropivacaine group ( p < 0.001 and p < 0.001 , respectively ) , as well as the time to first mobilization ( p < 0.001 ) .
CONCLUSIONS	Intra-operative systematic local infiltration analgesia reduces postoperative pain in patients undergoing vaginal hysterectomy , facilities mobilization and improves early recovery .

###25051209
BACKGROUND	Impaired functional performance and decreased muscle strength and muscle atrophy generally persist for a long period after total hip arthroplasty ( THA ) .
OBJECTIVE	To investigate the effects of weight-bearing ( WB ) and non-weight-bearing ( NWB ) exercises on functional performance , Harris hip score ( HHS ) , muscle strength and muscle thickness in women after THA .
METHODS	A randomised , controlled trial .
METHODS	Community .
METHODS	Sixty-five women who had undergone unilateral or bilateral THA at least 6 months before enrolment in the study .
METHODS	Participants were randomly allocated to the following groups : WB ( n = 22 ) , NWB ( n = 21 ) and control ( n = 22 ) groups .
METHODS	Participants in the WB and NWB groups performed daily home exercise programs for 8 weeks .
METHODS	Functional performance ( timed up and go , sit-to-stand , stair climbing , walking speed and 3-min walk test ) , HHS , isometric muscle strength of the hip and knee muscle and gluteus and quadriceps muscle thickness were measured at baseline and after 8 weeks .
RESULTS	An intention-to-treat analysis revealed that both the intervention groups exhibited significant improvements in almost all functional performance measures compared with the control group .
RESULTS	Furthermore , the WB group showed significantly greater pre-post changes in the sit-to-stand and 3-min walk test compared with the NWB group .
RESULTS	In terms of HHS , only the WB group showed significantly greater improvement compared with the control group .
RESULTS	Relative to the control group , improvements in all isometric strength measures were observed in both the intervention groups .
RESULTS	Significant improvement in quadriceps muscle thickness was observed in the WB group compared with the control group .
RESULTS	However , no significant difference was observed among the three groups in pre-post changes in gluteus muscle thickness .
CONCLUSIONS	WB and NWB home exercise programs were both effective for improving functional performance and muscle strength in women after THA .
CONCLUSIONS	However , the WB exercise was more effective than the NWB exercise for improving sit-to-stand ability and walking endurance .
CONCLUSIONS	In this study , we demonstrated that the WB exercise was more effective than the NWB exercise for improving functional performance in patients after THA .

###24891317
OBJECTIVE	To assess the efficacy of etanercept in the treatment of early active nonsteroidal antiinflammatory drug ( NSAID ) - refractory nonradiographic axial spondyloarthritis ( SpA ) .
METHODS	The study population consisted of patients who met the Assessment of SpondyloArthritis international Society ( ASAS ) classification criteria for axial SpA but not the modified New York radiographic criteria for ankylosing spondylitis ( as assessed by a radiologist at the central trial site ) , had a symptom duration of > 3 months but < 5 years , had a score of 4 on the Bath Ankylosing Spondylitis Disease Activity Index , and had been treated unsuccessfully with 2 NSAIDs .
METHODS	Patients were randomized to receive etanercept 50 mg/week or placebo and continued background NSAID treatment for 12 weeks ( double-blind study ) ; during the subsequent open-label period , all patients received etanercept 50 mg/week .
METHODS	The primary study end point was meeting the ASAS criteria for 40 % improvement ( ASAS40 ) at week 12 .
METHODS	Magnetic resonance imaging ( MRI ) of the sacroiliac joints and spine was performed at baseline and week 12 .
RESULTS	One hundred six patients were randomized to the etanercept group and 109 to the placebo group .
RESULTS	Of the 215 patients , the mean SD age at baseline was 32.0 7.8 years , 154 ( 72 % ) were HLA-B27 positive , and 174 ( 81 % ) had MRI-confirmed sacroiliitis .
RESULTS	At 12 weeks , the proportion of patients with improvement according to the ASAS40 was significantly higher in the etanercept group than in the placebo group ( 34 of 105 [ 32 % ] versus 17 of 108 [ 16 % ] ; P = 0.006 ) .
RESULTS	Patients who received etanercept exhibited a greater reduction in MRI-based scores for sacroiliac joint inflammation ( -46.9 % versus -10.9 % ; P < 0.001 ) and spinal inflammation ( -45.4 % versus -33.4 % ; P = 0.04 ) compared with placebo-treated patients at week 12 .
RESULTS	Post hoc analyses suggested a possible association between higher baseline C-reactive protein levels or MRI sacroiliac joint inflammation scores and higher rates of ASAS40 response to etanercept .
RESULTS	At week 24 , patients in the placebo group who had switched to etanercept at 12 weeks exhibited improvement similar to that observed in patients who had received etanercept for 24 weeks .
CONCLUSIONS	In patients with nonradiographic axial SpA , etanercept treatment was associated with rapid , significant improvement in symptomatic disease activity , function , and systemic and skeletal inflammation over 12 weeks ; clinical/functional improvement was sustained over 24 weeks .

###25589424
OBJECTIVE	Single-incision slings were developed to overcome the complications related to retropubic and trans-obturator tapes .
OBJECTIVE	TVT-Secur was the first of this kind of devices to be marketed and yielded contrasting results .
OBJECTIVE	Aim of this non-inferiority study is to report the 5-year follow-up of a randomized , single-blind , controlled trial comparing TVT-O to TVT-Secur .
METHODS	Randomized , single blind , controlled study conducted in two tertiary urogynecological centers .
METHODS	154 patients were allocated to either TVT-O or TVT-Secur and were contacted 5 years after the procedure to undergo urogynecological examination ( POP-Q staging , challenge stress test and post-void residual urine evaluation ) , to complete I-QOL and PGI-I questionnaires , and to score their satisfaction on a 5-point Likert scale .
METHODS	Patients who were not objectively evaluated were interviewed over the telephone .
METHODS	Primary outcome was subjective success defined as being `` very much improved '' or `` much improved '' on the PGI-I .
RESULTS	120 patients were evaluated only subjectively ( TVT-O : 62 ; TVT-Secur : 58 ) and 84 objectively and subjectively ( TVT-O : 46 ; TVT-Secur : 38 ) .
RESULTS	Subjective success ( 79 % vs. 63.8 % ) and objective cure rates ( 82.6 % vs. 68.4 % ) 5 years after the procedure were lower for TVT-Secur , but not significantly .
RESULTS	Recurrent UTIs were reported by 17.8 % of women ( TVT-O 9 , TVT-Secur 6 ) and two de novo urgency cases ( one per group ) were observed .
RESULTS	Re-operation rate for stress urinary incontinence ( SUI ) was 20 % .
CONCLUSIONS	TVT-Secur did not show an inferior subjective success rate in comparison with TVT-O five year after the original procedure , even though displaying a clear trend toward a lower efficacy .
CONCLUSIONS	Considering that the long-term safety profile is similar between the two procedures , there are no advantages in using TVT-Secur .

###25524399
BACKGROUND	People with rheumatoid arthritis are at greater risk of morbidity and mortality from cardiovascular disease than the general population .
BACKGROUND	Sustained physical activity increases cardio-respiratory fitness and reduces cardiovascular disease risk factors .
BACKGROUND	However , little is known about how we can effectively promote long-term participation in physical activity in patients with rheumatoid arthritis .
BACKGROUND	The literature consistently calls for physical activity interventions , and their implementation , to be theoretically-grounded .
METHODS	This paper documents the protocol of a randomised control trial that investigates whether a Self-determination Theory-based intervention fosters the adoption and maintenance of physical activity ( 3 , 6 and 12 months ) sufficient to provide sustained cardiovascular and personal well-being benefits in patients with rheumatoid arthritis .
METHODS	The cost effectiveness of the intervention will also be determined .
METHODS	The trial is registered as Current Controlled Trials ISRCTN04121489 .
CONCLUSIONS	Results from this trial will provide guidance regarding key social environmental factors that can be manipulated to support motivational processes conducive to positive health behaviour change and optimal functioning in patients with Rheumatoid Arthritis .

###24316342
OBJECTIVE	This study aimed to assess changes in oral health-related quality of life ( OHRQoL ) in individuals enroled in a double-blind randomized clinical trial conducted to evaluate the efficacy and safety of two carbamide peroxide concentrations used in at-home vital bleaching in the city of Pelotas , Southern Brazil .
METHODS	Ninety-two volunteers with a shade mean of C1 or darker for the six maxillary anterior teeth were randomized into two balanced groups ( n = 46 ) according to bleaching agent concentration : 10 % or 16 % carbamide peroxide .
METHODS	The patients were instructed to use the whitening agent in a tray for 2h once a day for three weeks .
METHODS	To assess changes in OHRQoL , participants completed the oral impact on daily performance ( OIDP ) at the start and one week after the completion of treatment .
METHODS	Because there was no difference with regard to whitening effect or tooth sensitivity during or after treatment the two groups were merged for the analyses of the current article .
METHODS	Before-and-after changes in OIDP scores were assessed by chi-square and McNemar tests ( p < 0.05 ) .
RESULTS	Mean pre - and post-treatment OIDP scores varied from 0.42 to 0.60 .
RESULTS	When the frequency of impacts for different activities were compared , there was an increase in difficulty in cleaning teeth ( p = 0.02 ) and a significant reduction in smiling and showing teeth with embarrassment ( p = 0.03 ) .
RESULTS	Regarding the symptoms and main oral conditions that generated impact , there was higher number of participants reporting pain ( p = 0.05 ) after treatment .
RESULTS	In opposite , significant decrease was observed in individuals reporting being unhappy with their appearance ( p = 0.03 ) .
RESULTS	On the contrary , it was showed a decrease in impacts resulting from dental colour was observed after bleaching ( p = 0.03 ) .
CONCLUSIONS	Quality of life is complex and encompasses different domains .
CONCLUSIONS	Although positive impact of the dental bleaching was detected , with patients showing more their teeth without embarrassment , difficult in dental hygiene and pain resulting from the treatment were also reported , and this can negatively impact daily performances .
CONCLUSIONS	Dentists must consider these aspects when performing aesthetics procedures .

###24460309
OBJECTIVE	The long-term efficacy of microwave hyperthermia combined with chemoradiotherapy in treating nasopharyngeal carcinoma ( NPC ) with metastatic foci in cervical lymph nodes was evaluated .
METHODS	A total of 154 cases of N2 or N3 stage NPC were randomized into two groups : hyperthermia group ( 76 cases ) and control group ( 78 cases ) .
METHODS	Both received cisplatin chemotherapy and radiotherapy .
METHODS	In addition , the hyperthermia group further received microwave hyperthermia to the metastatic cervical nodes with different patterns ( before or after radiotherapy ) , heating temperatures ( T90 < 43 and T90 43 ) and hyperthermia episodes ( < 4 times , 4-10 times and > 10 times ) .
RESULTS	The 3-month and 5-year complete response ( CR ) rates of cervical lymph nodes in the hyperthermia group were significantly higher than those in the control group .
RESULTS	The 5-year disease-free survival ( DFS ) rate and the 3-year / 5-year overall survival rate in the hyperthermia group were also significantly higher .
RESULTS	There was no significant difference in 5-year metastatic rates .
RESULTS	In the hyperthermia group , the 3-month and 5-year CR rates of T90 < 43 treatment were significantly lower than with T90 43 treatment .
RESULTS	The CR rate was highest when the hyperthermia was performed 4-10 times .
RESULTS	There were no significant differences in 3-month and 5-year CR rates between hyperthermia before or after radiotherapy treatment .
CONCLUSIONS	Microwave hyperthermia combined with chemoradiotherapy can increase local control , DFS and 3 , 5-year overall survival rates of patients with N2 ~ N3 stage NPC .
CONCLUSIONS	The heating temperature should be over 43 with hyperthermia repeated 4-10 times .

###24965545
BACKGROUND	Bariatric surgery may be beneficial in mildly obese patients with poorly controlled diabetes .
BACKGROUND	The optimal procedure to achieve diabetes remission is unknown .
BACKGROUND	In 2011 , we published the short-term results of a pilot study designed to evaluate the efficacy of diabetic control and the role of duodenal exclusion in mildly obese diabetic patients undergoing laparoscopic sleeve gastrectomy ( SG ) vs. a laparoscopic single anastomosis ( mini - ) gastric bypass ( SAGB ) .
BACKGROUND	This study analyzes the 5-year results and evaluates the incretin effect .
METHODS	A double-blind randomized trial included 60 participants with a hemoglobin A1c ( HbA1c ) level higher than 7.5 % , a body mass index ( BMI ) between 25 and 35 Kg/m ( 2 ) , a C-peptide level 1.0 ng/mL , and a diagnosis of type 2 diabetes mellitus ( T2DM ) for at least 6 months .
METHODS	A SAGB with duodenal exclusion or a SG without duodenal exclusion was performed .
RESULTS	The 5-year results of the primary outcome were as an intention-to-treat analysis for HbA1c 6.5 % without glycemic therapy .
RESULTS	Assessments of the incretin effect and cell function were performed at baseline and between 36 and 60 months .
RESULTS	The patients were randomly assigned to SAGB ( n = 30 ) and SG ( n = 30 ) .
RESULTS	At 60 months , 18 participants ( 60 % ; 95 % confidence interval ( CI ) , 42 to 78 % ) in the SAGB group and nine participants ( 30 % ; 95 % CI , 13 to 47 % ) in the SG group achieved the primary end points ( odds ratio ( OR ) , 0.3 ; 95 % CI , 0.1 to 0.8 % ) .
RESULTS	The participants assigned to the SAGB procedure had a similar percentage of weight loss as the SG patients ( 22.85.9 vs. 20.15.3 % ; p > 0.05 ) but achieved a lower level of HbA1c ( 6.10.7 vs. 7.11.2 % ; p < 0.05 ) than the SG patients .
RESULTS	There was a significant increase in the incretin effect before and after surgery in both groups , but the SAGB group had a higher incretin effect than the SG group at 5 years .
CONCLUSIONS	In mildly obese patients with T2DM , SG is effective at improving glycemic control at 5 years , but SAGB was more likely to achieve better glycemic control than SG and had a higher incretin effect compared to SG .

###25918291
OBJECTIVE	We evaluated the effectiveness of a low-intensity , home-based physical activity program ( Onco-Move ) and a moderate - to high-intensity , combined supervised resistance and aerobic exercise program ( OnTrack ) versus usual care ( UC ) in maintaining or enhancing physical fitness , minimizing fatigue , enhancing health-related quality of life , and optimizing chemotherapy completion rates in patients undergoing adjuvant chemotherapy for breast cancer .
METHODS	We randomly assigned patients who were scheduled to undergo adjuvant chemotherapy ( N = 230 ) to Onco-Move , OnTrack , or UC .
METHODS	Performance-based and self-reported outcomes were assessed before random assignment , at the end of chemotherapy , and at the 6-month follow-up .
METHODS	We used generalized estimating equations to compare the groups over time .
RESULTS	Onco-Move and OnTrack resulted in less decline in cardiorespiratory fitness ( P < .001 ) , better physical functioning ( P .001 ) , less nausea and vomiting ( P = .029 and .031 , respectively ) and less pain ( P = .003 and .011 , respectively ) compared with UC .
RESULTS	OnTrack also resulted in better outcomes for muscle strength ( P = .002 ) and physical fatigue ( P < .001 ) .
RESULTS	At the 6-month follow-up , most outcomes returned to baseline levels for all three groups .
RESULTS	A smaller percentage of participants in OnTrack required chemotherapy dose adjustments than those in the UC or Onco-Move groups ( P = .002 ) .
RESULTS	Both intervention groups returned earlier ( P = .012 ) , as well as for more hours per week ( P = .014 ) , to work than the control group .
CONCLUSIONS	A supervised , moderate - to high-intensity , combined resistance and aerobic exercise program is most effective for patients with breast cancer undergoing adjuvant chemotherapy .
CONCLUSIONS	A home-based , low-intensity physical activity program represents a viable alternative for women who are unable or unwilling to follow the higher intensity program .

###25858408
OBJECTIVE	Distress and pain associated with immunisation are significant problems for children , carers and healthcare professionals .
OBJECTIVE	This study was designed to determine whether distraction by watching cartoons during immunisation could reduce the distress and pain perceived by the children .
METHODS	A sample of 35 six year olds was randomly assigned to one of two groups : the first was distracted by standard techniques during immunisation , the second by watching cartoons .
METHODS	Levels of distress were measured with the amended observation scale of behavioural distress , and of pain by the Wong-Baker FACES pain rating scale .
RESULTS	The levels of distress were significantly lower in the group distracted by cartoons compared with children who received traditional distraction techniques during immunisation .
CONCLUSIONS	By using an easy , cheap intervention , children 's first introduction to health services can be made a positive experience which will decrease the number developing pre-procedural anxiety or a fear of needles .

###25385705
OBJECTIVE	To assess for the frequency of binge eating behavior and its association with weight loss in an overweight/obese sample of veterans .
METHODS	This study is a secondary analysis of data from the ASPIRE study , a randomized effectiveness trial of weight loss among veterans .
METHODS	Of the 481 enrolled veterans with overweight/obesity , binge eating frequency was obtained by survey for 392 ( 82 % ) .
RESULTS	The majority ( 77.6 % ) reported binge eating , and 6.1 % reported high-frequency binge eating .
RESULTS	Those reporting any binge eating lost 1.4 % of body weight , decreased waist circumference by 2.0 cm , and had significantly worse outcomes than those reporting never binge eating who lost about double the weight ( 2.7 % ) and reduced waist circumference by twice as much ( 4.2 cm ) .
RESULTS	The high-frequency binge group gained 1.4 % of body weight and increased waist circumference by 0.3 cm .
CONCLUSIONS	High rates of binge eating were observed in an overweight/obese sample of veterans enrolled in weight loss treatment .
CONCLUSIONS	The presence of binge eating predicted poorer weight loss outcomes .
CONCLUSIONS	Furthermore , high-frequency binge eating was associated with weight gain .
CONCLUSIONS	These findings have operational and policy implications for developing effective strategies to address binge eating in the context of behavioral weight loss programs for veterans .

###25934044
BACKGROUND	Urinary tract infections ( UTIs ) are common drivers of antibiotic use .
BACKGROUND	The minimal effective duration of antibiotic therapy for UTIs is unknown , but any reduction is important to diminish selection pressure for antibiotic resistance , costs , and drug-related side-effects .
BACKGROUND	The aim of this study was to investigate whether an algorithm based on procalcitonin ( PCT ) and quantitative pyuria reduces antibiotic exposure .
METHODS	From April 2012 to March 2014 , we conducted a factorial design randomized controlled open-label trial .
METHODS	Immunocompetent adults with community-acquired non-catheter-related UTI were enrolled in the emergency department of a tertiary-care 600-bed hospital in northwestern Switzerland .
METHODS	Clinical presentation was used to guide initiation and duration of antibiotic therapy according to current guidelines ( control group ) or with a PCT-pyuria-based algorithm ( PCT-pyuria group ) .
METHODS	The primary endpoint was overall antibiotic exposure within 90 days .
METHODS	Secondary endpoints included duration of the initial antibiotic therapy , persistent infection 7 days after end of therapy and 30 days after enrollment , recurrence and rehospitalizations within 90 days .
RESULTS	Overall , 394 patients were screened , 228 met predefined exclusion criteria , 30 declined to participate , and 11 were not eligible .
RESULTS	Of these , 125 ( 76 % women ) were enrolled in the intention-to-treat ( ITT ) analysis and 96 patients with microbiologically confirmed UTI constituted the per protocol group ; 84 of 125 ( 67 % ) patients had a febrile UTI , 28 ( 22 % ) had bacteremia , 5 ( 4 % ) died , and 3 ( 2 % ) were lost to follow-up .
RESULTS	Overall antibiotic exposure within 90 days was shorter in the PCT-pyuria group than in the control group ( median 7.0 [ IQR , 5.0-14 .0 ] vs. 10.0 [ IQR , 7.0-16 .0 ] days , P = 0.011 ) in the ITT analysis .
RESULTS	Mortality , rates of persistent infections , recurrences , and rehospitalizations were not different .
CONCLUSIONS	A PCT-pyuria-based algorithm reduced antibiotic exposure by 30 % when compared to current guidelines without apparent negative effects on clinical outcomes .

###24450857
BACKGROUND	Patients with relapsed chronic lymphocytic leukemia ( CLL ) who have clinically significant coexisting medical conditions are less able to undergo standard chemotherapy .
BACKGROUND	Effective therapies with acceptable side-effect profiles are needed for this patient population .
METHODS	In this multicenter , randomized , double-blind , placebo-controlled , phase 3 study , we assessed the efficacy and safety of idelalisib , an oral inhibitor of the delta isoform of phosphatidylinositol 3-kinase , in combination with rituximab versus rituximab plus placebo .
METHODS	We randomly assigned 220 patients with decreased renal function , previous therapy-induced myelosuppression , or major coexisting illnesses to receive rituximab and either idelalisib ( at a dose of 150 mg ) or placebo twice daily .
METHODS	The primary end point was progression-free survival .
METHODS	At the first prespecified interim analysis , the study was stopped early on the recommendation of the data and safety monitoring board owing to overwhelming efficacy .
RESULTS	The median progression-free survival was 5.5 months in the placebo group and was not reached in the idelalisib group ( hazard ratio for progression or death in the idelalisib group , 0.15 ; P < 0.001 ) .
RESULTS	Patients receiving idelalisib versus those receiving placebo had improved rates of overall response ( 81 % vs. 13 % ; odds ratio , 29.92 ; P < 0.001 ) and overall survival at 12 months ( 92 % vs. 80 % ; hazard ratio for death , 0.28 ; P = 0.02 ) .
RESULTS	Serious adverse events occurred in 40 % of the patients receiving idelalisib and rituximab and in 35 % of those receiving placebo and rituximab .
CONCLUSIONS	The combination of idelalisib and rituximab , as compared with placebo and rituximab , significantly improved progression-free survival , response rate , and overall survival among patients with relapsed CLL who were less able to undergo chemotherapy .
CONCLUSIONS	( Funded by Gilead ; ClinicalTrials.gov number , NCT01539512 . )

###25355722
BACKGROUND	We characterized the incidence of central nervous system ( CNS ) metastases after treatment with trastuzumab emtansine ( T-DM1 ) versus capecitabine-lapatinib ( XL ) , and treatment efficacy among patients with pre-existing CNS metastases in the phase III EMILIA study .
METHODS	In EMILIA , patients with human epidermal growth factor receptor 2 ( HER2 ) - positive advanced breast cancer previously treated with trastuzumab and a taxane were randomized to T-DM1 or XL until disease progression .
METHODS	Patients with treated , asymptomatic CNS metastases at baseline and patients developing postbaseline CNS metastases were identified retrospectively by independent review ; exploratory analyses were carried out .
RESULTS	Among 991 randomized patients ( T-DM1 = 495 ; XL = 496 ) , 95 ( T-DM1 = 45 ; XL = 50 ) had CNS metastases at baseline .
RESULTS	CNS progression occurred in 9 of 450 ( 2.0 % ) and 3 of 446 ( 0.7 % ) patients without CNS metastases at baseline in the T-DM1 and XL arms , respectively , and in 10 of 45 ( 22.2 % ) and 8 of 50 ( 16.0 % ) patients with CNS metastases at baseline .
RESULTS	Among patients with CNS metastases at baseline , a significant improvement in overall survival ( OS ) was observed in the T-DM1 arm compared with the XL arm [ hazard ratio ( HR ) = 0.38 ; P = 0.008 ; median , 26.8 versus 12.9 months ] .
RESULTS	Progression-free survival by independent review was similar in the two treatment arms ( HR = 1.00 ; P = 1.000 ; median , 5.9 versus 5.7 months ) .
RESULTS	Multivariate analyses demonstrated similar results .
RESULTS	Grade 3 adverse events were reported in 48.8 % and 63.3 % of patients with CNS metastases at baseline administered T-DM1 and XL , respectively ; no new safety signals were observed .
CONCLUSIONS	In this retrospective , exploratory analysis , the rate of CNS progression in patients with HER2-positive advanced breast cancer was similar for T-DM1 and for XL , and higher overall in patients with CNS metastases at baseline compared with those without CNS metastases at baseline .
CONCLUSIONS	In patients with treated , asymptomatic CNS metastases at baseline , T-DM1 was associated with significantly improved OS compared with XL .

###24918848
OBJECTIVE	to analyze the morphological structure of cardiac , blood pressure ( BP ) , heart rate ( HR ) and heart rate variability ( HRV ) of rats subjected to physical training with supplementation of caffeine .
METHODS	60 rats were divided into 4 groups : control ( CO ) , control with caffeine ( CAF ) , trained control ( TRE ) and trained with caffeine ( TCAF ) .
METHODS	All trained groups underwent 4 weeks of swimming , and all caffeine groups were supplemented by voluntary ingestion of caffeine diluted in drinking water .
RESULTS	there were no changes to BP and HR between groups .
RESULTS	Regarding HRV , there was a decrease in LFnorm ( low frequency ) and LF/HF ratio ( low and high frequency ) in TCAF and CAF compared to group ( p < 0.02 and p < 0.03 , respectively ) .
RESULTS	An increase occurred in CAF compared to the CO in the component LFnorm ( p < 0.05 ) .
RESULTS	The results also showed an increase in the relative weight of heart in the TRE ( p < 0.04 ) and TCAF ( p < 0.03 ) compared to CO. .
CONCLUSIONS	caffeine did not modify the hemodynamic responses .
CONCLUSIONS	However , physical training resulted in a decrease in sympathetic response and an increase in relative heart weight .

###25332472
BACKGROUND	Mexico 's sugar-sweetened beverage ( SSB ) intake is among the highest globally .
BACKGROUND	Although evidence shows that increases in SSB intake are linked with increased energy intake , weight gain , and cardiometabolic risks , few randomized clinical trials have been conducted in adults .
OBJECTIVE	The aim of this study was to determine if replacing SSBs with water affects plasma triglycerides ( TGs ) ( primary outcome ) , weight , and other cardiometabolic factors .
METHODS	We selected overweight/obese ( BMI 25 and < 39 kg/m ( 2 ) ) women ( 18-45 y old ) reporting an SSB intake of at least 250 kcal/d living in Cuernavaca , Mexico .
METHODS	Women were randomly allocated to the water and education provision ( WEP ) group ( n = 120 ) or the education provision ( EP ) - only group ( n = 120 ) .
METHODS	The WEP group received biweekly water deliveries , and both groups received equal monthly nutrition counseling .
METHODS	During nutrition counseling , the WEP group sessions included activities to encourage increased water intake , reduced SSB intake , and substitution of water for SSBs .
METHODS	Repeated 24-h dietary recalls , anthropometric measurements , and fasting blood samples were collected at baseline and at 3 , 6 , and 9 mo. .
METHODS	The Markov-Monte Carlo method was used for multiple imputation ; separate mixed-effects models tested each outcome .
RESULTS	An intent-to-treat ( ITT ) analysis indicated that the WEP group increased water intake and decreased SSB intake significantly over time , but there were no differences in plasma TG concentrations between groups at the end of the intervention ( WEP at baseline : 155 2.10 mg/dL ; WEP at 9 mo : 149 2.80 mg/dL ; EP at baseline : 150 1.90 mg/dL ; EP at 9 mo : 161 2.70 mg/dL ; P for mean comparisons at 9 mo = 0.10 ) .
RESULTS	Secondary analyses showed significant effects on plasma TGs ( change from baseline to 9 mo : WEP , -28.9 7.7 mg/dL ; EP , 8.5 10.9 mg/dL ; P = 0.03 ) and metabolic syndrome ( MetS ) prevalence at 9 mo ( WEP : 18.1 % ; EP : 37.7 % ; P = 0.02 ) among obese participants .
CONCLUSIONS	Providing water and nutritional counseling was effective in increasing water intake and in partially decreasing SSB intake .
CONCLUSIONS	We found no effect on plasma TGs , weight , and other cardiometabolic risks in the ITT analysis , although the intervention lowered plasma TGs and MetS prevalence among obese participants .
CONCLUSIONS	Further studies are warranted .
CONCLUSIONS	This trial was registered at http://www.clinicaltrials.gov as NCT01245010 .

###25495315
OBJECTIVE	To measure the costs of a polypill strategy and compare them with those of usual care in people with established cardiovascular disease ( CVD ) or at similarly high cardiovascular risk .
METHODS	A within-trial cost analysis of polypill-based care versus usual care with separate medications , using data from the Kanyini Guidelines Adherence with the Polypill ( GAP ) trial and linked health service and medication administrative claims data .
METHODS	Kanyini GAP participants who consented to Australian Medicare record access .
METHODS	Mean health service and pharmaceutical expenditure per patient per year , estimated with generalised linear models .
METHODS	Costs during the trial ( randomisation January 2010 - May 2012 , median follow-up 19 months , maximum follow-up 36 months ) were inflated to 2012 costs .
RESULTS	Our analysis showed a statistically significantly lower mean pharmaceutical expenditure of $ 989 ( 95 % CI , $ 648 - $ 1331 ) per patient per year in the polypill arm compared with usual care ( P < 0.001 ; adjusted , excluding polypill cost ) .
RESULTS	No significant difference was shown in health service expenditure .
CONCLUSIONS	This study provides evidence of significant cost savings to the taxpayer and Australian Government through the introduction of a CVD polypill strategy .
CONCLUSIONS	The savings will be less now than during the trial due to subsequent reductions in the costs of usual care .
CONCLUSIONS	Nonetheless , given the prevalence of CVD in Australia , the introduction of this polypill could increase considerably the efficiency of health care expenditure in Australia .
BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN126080005833347 .

###24685276
BACKGROUND	Fingolimod has shown reductions in clinical and MRI disease activity in patients with relapsing-remitting multiple sclerosis .
BACKGROUND	We further assessed the efficacy and safety of fingolimod in such patients .
METHODS	We did this placebo-controlled , double-blind phase 3 study predominantly in the USA ( 101 of 117 centres ) .
METHODS	Using a computer-generated sequence , we randomly allocated eligible patients-those aged 18-55 years with relapsing-remitting multiple sclerosis-to receive fingolimod 05 mg , fingolimod 125 mg , or placebo orally once daily ( 1:1:1 ; stratified by study centre ) .
METHODS	On Nov 12 , 2009 , all patients assigned to fingolimod 125 mg were switched to the 05 mg dose in a blinded manner after a review of data from other phase 3 trials and recommendation from the data and safety monitoring board , but were analysed as being in the 125 mg group in the primary outcome analysis .
METHODS	Our primary endpoint was annualised relapse rate at month 24 , analysed by intention to treat .
METHODS	Secondary endpoints included percentage brain volume change ( PBVC ) from baseline and time-to-disability-progression confirmed at 3 months .
METHODS	This trial is registered with ClinicalTrilals.gov , number NCT00355134 .
RESULTS	Between June 30 , 2006 , and March 4 , 2009 , we enrolled and randomly allocated 1083 patients : 370 to fingolimod 125 mg , 358 to fingolimod 05 mg , and 355 to placebo .
RESULTS	Mean annualised relapse rate was 040 ( 95 % CI 034-048 ) in patients given placebo and 021 ( 017-025 ) in patients given fingolimod 05 mg : rate ratio 052 ( 95 % CI 040-066 ; p < 00001 ) , corresponding to a reduction of 48 % with fingolimod 05 mg versus placebo .
RESULTS	Mean PBVC was -086 ( SD 122 ) for fingolimod 05 mg versus -128 ( 150 ) for placebo ( treatment difference -041 , 95 % CI -062 to -020 ; p = 00002 ) .
RESULTS	We recorded no statistically significant between-group difference in confirmed disability progression ( hazard rate 083 with fingolimod 05 mg vs placebo ; 95 % CI 061-112 ; p = 0227 ) .
RESULTS	Fingolimod 05 mg caused more of the following adverse events versus placebo : lymphopenia ( 27 [ 8 % ] patients vs 0 patients ) , increased alanine aminotransferase ( 29 [ 8 % ] vs six [ 2 % ] ) , herpes zoster infection ( nine [ 3 % ] vs three [ 1 % ] ) , hypertension ( 32 [ 9 % ] vs 11 [ 3 % ] ) , first-dose bradycardia ( five [ 1 % ] vs one [ < 05 % ] ) , and first-degree atrioventricular block ( 17 [ 5 % ] vs seven [ 2 % ] ) .
RESULTS	53 ( 15 % ) of 358 patients given fingolimod 05 mg and 45 ( 13 % ) of 355 patients given placebo had serious adverse events over 24 months , which included basal-cell carcinoma ( ten [ 3 % ] patients vs two [ 1 % ] patients ) , macular oedema ( three [ 1 % ] vs two [ 1 % ] ) , infections ( 11 [ 3 % ] vs four [ 1 % ] ) , and neoplasms ( 13 [ 4 % ] vs eight [ 2 % ] ) .
CONCLUSIONS	Our findings expand knowledge of the safety profile of fingolimod and strengthen evidence for its beneficial effects on relapse rates in patients with relapsing-remitting multiple sclerosis .
CONCLUSIONS	We saw no effect of fingolimod on disability progression .
CONCLUSIONS	Our findings substantiate the beneficial profile of fingolimod as a disease-modifying agent in the management of patients with relapsing-remitting multiple sclerosis .
BACKGROUND	Novartis Pharma AG .

###25936237
OBJECTIVE	To compare the efficacy of heart-shaped intrauterine balloon and intrauterine contraceptive device ( IUD ) in the prevention of adhesion reformation after hysteroscopic adhesiolysis .
METHODS	Prospective , randomized , controlled trial .
METHODS	University hospital .
METHODS	A total of 201 women with Asherman syndrome .
METHODS	Women were randomized to having either a heart-shaped intrauterine balloon or an IUD fitted after hysteroscopic adhesiolysis .
METHODS	The devices were removed after 7days .
METHODS	A second-look hysteroscopy was carried out 1 to 2months after the surgery .
METHODS	Incidence of adhesion reformation and reduction of adhesion score before and after surgery .
RESULTS	Initially 201 cases were recruited ; 39 cases dropped out , resulting in 82 cases in the balloon group and 80 cases in IUD group .
RESULTS	The age , menstrual characteristics , pregnancy history , and American Fertility Society score before surgery were comparable between the two groups .
RESULTS	The median adhesion score reduction ( balloon group , 7 ; IUD group , 7 ) and the adhesion reformation rate ( balloon group , 30 % ; IUD group , 35 % ) were not significantly different between the two groups .
CONCLUSIONS	The heart-shaped intrauterine balloon and IUD are of similar efficacy in the prevention of adhesion reformation after hysteroscopic adhesiolysis for Asherman syndrome .
BACKGROUND	ISRCTN 69690272 .

###24246498
BACKGROUND	Heterogeneous clinical presentation and gender differences were reported in Charcot-Marie-Tooth disease type 1A ( CMT1A ) .
METHODS	This report examined demographic and clinical data collected during a randomised controlled trial , to describe the clinical spectrum of a large and well-defined cohort of CMT1A patients .
RESULTS	Among the 189 symptomatic patients screened , three patients ( 1.6 % ) reported first symptoms in the upper limbs , which may be misleading when establishing the clinical diagnosis .
RESULTS	The quality of life ( QoL ) of patients was significantly deteriorated compared to the standard population , and slightly better compared to multiple sclerosis patients .
RESULTS	According to the literature , patients reported several disorders which may be associated with CMT1A , including auditory dysfunction ( 7.9 % ) , Carpal Tunnel Syndrome ( CTS ) ( 7.9 % ) or sleep apnoea ( 4.2 % ) .
RESULTS	Compared to available data , we reported more patients with CTS and fewer patients with sleep apnoea .
RESULTS	Women were more affected by CTS than men ( 11 % and 2.8 % , respectively ) .
RESULTS	Women also reported an earlier onset of symptoms than men ( 8.69.5 years and 13.114 years , respectively ) , higher deterioration of their QoL and higher disability of their upper limb , assessed by Overall Neuropathy Limitation Scale ( p = 0.023 ) .
CONCLUSIONS	This information will be useful for better understanding of this disease and for designing future clinical studies .

###26136585
BACKGROUND	Olive oil polyphenols have shown protective effects on cardiovascular risk factors .
BACKGROUND	Their consumption decreased oxidative stress biomarkers and improved some features of the lipid profile .
BACKGROUND	However , their effects on LDL concentrations in plasma and LDL atherogenicity have not yet been elucidated .
OBJECTIVE	Our objective was to assess whether the consumption of olive oil polyphenols could decrease LDL concentrations [ measured as apolipoprotein B-100 ( apo B-100 ) concentrations and the total number of LDL particles ] and atherogenicity ( the number of small LDL particles and LDL oxidizability ) in humans .
METHODS	The study was a randomized , cross-over controlled trial in 25 healthy European men , aged 20-59 y , in the context of the EUROLIVE ( Effect of Olive Oil Consumption on Oxidative Damage in European Populations ) study .
METHODS	Volunteers ingested 25 mL/d raw low-polyphenol-content olive oil ( LPCOO ; 366 mg/kg ) or high-polyphenol-content olive oil ( HPCOO ; 2.7 mg/kg ) for 3 wk .
METHODS	Interventions were preceded by 2-wk washout periods .
METHODS	Effects of olive oil polyphenols on plasma LDL concentrations and atherogenicity were determined in the sample of 25 men .
METHODS	Effects on lipoprotein lipase ( LPL ) gene expression were assessed in another sample of 18 men from the EUROLIVE study .
RESULTS	Plasma apo B-100 concentrations and the number of total and small LDL particles decreased ( mean SD : by 5.94 % 16.6 % , 11.9 % 12.0 % , and 15.3 % 35.1 % , respectively ) from baseline after the HPCOO intervention .
RESULTS	These changes differed significantly from those after the LPCOO intervention , which resulted in significant increases of 6.39 % 16.6 % , 4.73 % 22.0 % , and 13.6 % 36.4 % from baseline ( P < 0.03 ) .
RESULTS	LDL oxidation lag time increased by 5.0 % 10.3 % from baseline after the HPCOO intervention , which was significantly different only relative to preintervention values ( P = 0.038 ) .
RESULTS	LPL gene expression tended to increase by 26 % from baseline after the HPCOO intervention ( P = 0.08 ) and did not change after the LPCOO intervention .
CONCLUSIONS	The consumption of olive oil polyphenols decreased plasma LDL concentrations and LDL atherogenicity in healthy young men .
CONCLUSIONS	This trial was registered at www.controlled-trials.com as ISRCTN09220811 .

###25514302
OBJECTIVE	Hepatitis B virus ( HBV ) reactivation is a serious complication for patients with lymphoma treated with rituximab-containing chemotherapies , despite lamivudine prophylaxis treatment .
OBJECTIVE	An optimal prophylactic antiviral protocol has not been determined .
OBJECTIVE	To compare the efficacy of entecavir and lamivudine in preventing HBV reactivation in patients seropositive for the hepatitis B surface antigen with untreated diffuse large B-cell lymphoma receiving chemotherapy treatment with rituximab , cyclophosphamide , doxorubicin , vincristine , and prednisone ( R-CHOP ) .
METHODS	Randomized , open-label , phase 3 study conducted from February 2008 through December 2012 at 10 medical centers in China .
METHODS	This study was a substudy of a parent study designed to compare a 3-week with a 2-week R-CHOP chemotherapy regimen for untreated diffuse large B-cell lymphoma .
METHODS	Patients enrolled in the parent study who were seropositive for the hepatitis B surface antigen and had normal liver function , serum HBV DNA levels of less than 103 copies/mL , and no prior antiviral therapy were randomized to entecavir ( n = 61 ) or lamivudine ( n = 60 ) .
METHODS	Daily entecavir ( 0.5 mg ) or lamivudine ( 100 mg ) beginning 1 week before the initiation of R-CHOP treatment to 6 months after completion of chemotherapy .
METHODS	The primary efficacy end point was the incidence of HBV-related hepatitis .
METHODS	The secondary end points included rates of HBV reactivation , chemotherapy disruption due to hepatitis , and treatment-related adverse events .
RESULTS	There were 121 patients randomly assigned to receive entecavir ( n = 61 ) or lamivudine ( n = 60 ) .
RESULTS	The date of last patient follow-up was May 25 , 2013 .
RESULTS	The rates were significantly lower for the entecavir group vs the lamivudine group for HBV-related hepatitis ( 0 % vs 13.3 % , respectively ; difference between groups , 13.3 % [ 95 % CI , 4.7 % to 21.9 % ] ; P = .003 ) , HBV reactivation ( 6.6 % vs 30 % ; difference , 23.4 % [ 95 % CI , 10.2 % to 36.6 % ] ; P = .001 ) , and chemotherapy disruption ( 1.6 % vs 18.3 % ; difference , 16.7 % [ 95 % CI , 6.4 % to 27.0 % ] ; P = .002 ) .
RESULTS	Of the 61 patients in the entecavir group , 15 ( 24.6 % ) experienced treatment-related adverse events .
RESULTS	Of 60 patients in the lamivudine group , 18 ( 30 % ) experienced treatment-related adverse events ( difference between entecavir and lamivudine groups , 5.4 % [ 95 % CI , -10.5 % to 21.3 % ] ; P = .50 ) .
CONCLUSIONS	Among patients seropositive for the hepatitis B surface antigen with diffuse large B-cell lymphoma undergoing R-CHOP chemotherapy , the addition of entecavir compared with lamivudine resulted in a lower incidence of HBV-related hepatitis and HBV reactivation .
CONCLUSIONS	If replicated , these findings support the use of entecavir in these patients .
BACKGROUND	clinicaltrials.gov Identifier : NCT01793844 ; Chinese Clinical Trial Registry Identifier : CTR-TRC-11001687 .

###24814202
BACKGROUND	Propofol ( PRO ) and dexmedetomidine ( DEX ) are commonly used to produce anesthesia and sedation for routine MRI procedures .
BACKGROUND	Children with complex conditions often require much lengthy MRI for multi-body-part scans with frequent scanner coil changes and patient body reposition .
BACKGROUND	This study compared PRO and DEX techniques on outcomes for the particular MRI setting with longer than 1 h duration .
METHODS	95 children , aged from 1 to 7 years , scheduled for MRI > 75 min were randomly assigned to PRO or DEX group .
METHODS	After induced with sevoflurane , a loading dose of PRO ( 2 mgkg ( -1 ) ) was administrated and followed by continuous infusion ( 200 gkg ( -1 ) min ( -1 ) ) ; a loading dose of DEX ( 2 gkg ( -1 ) ) was administrated and followed by continuous infusion ( 2 gkg ( -1 ) h ( -1 ) ) .
METHODS	Patients received O ( 2 ) by nasal cannula .
METHODS	The observed outcomes were times for induction , MRI , emergence , and recovery , and total time ( induction to discharge ) ; MRI pauses from patient movement ; incidence of technique failure and critical events ; emergence and behavior in postanesthesia care unit ( PACU ) ; parental satisfaction ; and arterial pressure ( BP ) and heart rate ( HR ) during anesthesia .
RESULTS	PRO compared with DEX showed significantly less time for anesthesia induction ( 16.3 versus 24.2 min ) , emergence ( 21.2 versus 39.9 min ) , PACU ( 35.7 versus 62.5 min ) , and total time ( 135 versus 173 min ) ( all P < 0.001 ) .
RESULTS	There were significantly fewer pauses during MRI and lower failure rate to complete MRI in PRO versus DEX ( 0.22 versus 0.81 , P = 0.01 and 1 versus 15 , P < 0.001 ) , less behavioral disturbances in PACU , and higher parental satisfaction in PRO versus DEX ( P < 0.01 ) .
RESULTS	There were no critical events in either group : In PRO , mean BP during MRI ( from 52 8 to 58 mmHg ) was significantly less than before anesthesia ( 80 12 mmHg ) , while HR remained relatively constant ( range of 97-103 ) at its baseline of 108 21 , but in DEX , mean BP remained unchanged ( from 76 12 to 78 15 ) during anesthesia compared with before anesthesia ( 79 14 mmHg ) , while HR decreased ( 74 16 to 78 15 ) during anesthesia from its baseline ( 102 17 ) .
CONCLUSIONS	For children undergoing lengthy multicomponent MRI , the propofol technique yielded overall better outcomes than the dexmedetomedine technique in terms of timeliness , PACU emergence characteristics , and parental satisfaction .

###24806030
OBJECTIVE	Both metformin and acarbose are recommended monotherapy and add-on therapy in type 2 diabetes mellitus ( T2DM ) .
OBJECTIVE	A fixed-dose combination ( FDC ) of acarbose and metformin has been developed to reduce pill burden and potentially improve compliance .
OBJECTIVE	The current study investigated the bioequivalence of the acarbose/metformin FDC compared with the individual agents administered simultaneously ( loose combination ) .
OBJECTIVE	Secondary endpoints were the safety and tolerability of the FDC and the potential for drug-drug interactions between acarbose and metformin .
METHODS	A single-centre , randomized , open-label , four-period crossover study was conducted in healthy male Korean subjects aged 18-45years .
METHODS	Following one-period balanced Williams design , participants were randomized to receive four single oral treatments on different study days separated by 7days ' washout .
METHODS	Treatments were as follows : ( i ) acarbose/metformin 50/500mg FDC ( test ) ; ( ii ) acarbose 50mg and metformin 500mg as loose combination ( reference ) ; ( iii ) acarbose 50mg ; and ( iv ) metformin 500mg .
METHODS	Serial blood samples were taken for glucose and insulin levels for 4h after a sucrose load on the day before and day of study drug administration .
METHODS	Additionally , serial blood samples were taken for analysis of metformin levels for 24h after each drug containing metformin .
METHODS	The area under the curve for 4h post-test ( AUC0-4h ) and the maximal serum concentration ( Cmax ) of plasma glucose and serum insulin were primary pharmacodynamic ( PD ) parameters , and Cmax , AUC0-last and AUC for metformin levels were primary pharmacokinetic ( PK ) parameters .
METHODS	The bioequivalence of the FDC to the loose combination was considered established if the 90 % confidence intervals ( CIs ) of the baseline-adjusted PD parameter ratios ( test vs. reference ) for plasma glucose and the PK parameter ratios for metformin fell completely within current acceptance limits ( 08-125 ) .
CONCLUSIONS	Thirty-three of 40 randomized subjects completed the study ; five withdrew consent and two discontinued because of adverse events ( AEs ) .
CONCLUSIONS	The 24-h plasma concentration-time curves of metformin and the 4-h plasma glucose-time curves after acarbose/metformin FDC ( test ) and acarbose + metformin loose combination ( reference ) were almost superimposable .
CONCLUSIONS	The geometric least squares ( LS ) mean of the RatioAUC and RatioCmax for plasma glucose after the FDC vs. loose combination , and the LS mean of the ratios in metformin AUC , AUC0-last and Cmax were close to unity , and the 90 % CI of all these parameters fell within the predefined equivalence range of 08-125 , confirming bioequivalence .
CONCLUSIONS	The metformin AUC was reduced by 26 % and Cmax by 34 % after acarbose + metformin compared with metformin alone .
CONCLUSIONS	Eight subjects ( 200 % ) reported AEs , but all were mild , and most were gastrointestinal , as expected for these agents .
CONCLUSIONS	The incidence of AEs was not higher with the combinations vs. monotherapy .
CONCLUSIONS	These data demonstrate that the acarbose/metformin FDC is bioequivalent to the loose combination of these agents .
CONCLUSIONS	Although acarbose slightly reduced the bioavailability of metformin , the accumulated evidence of the efficacy of this combination implies that this is clinically irrelevant .
CONCLUSIONS	The observed AE profile was consistent with the established knowledge on the safety of the two drugs .

###24630878
OBJECTIVE	The purpose of this study was to assess the in vitro P2Y12 receptor inhibitory effects of cangrelor on platelets from patients on maintenance prasugrel therapy treated with 2 reloading dose regimens .
BACKGROUND	Despite its more potent and rapid antiplatelet effects compared with clopidogrel , recent studies have shown variability in prasugrel-mediated P2Y12 receptor inhibition , particularly in high-risk settings .
BACKGROUND	Cangrelor is a potent intravenous P2Y12 receptor inhibitor .
METHODS	A total of 60 patients with coronary artery disease on maintenance prasugrel ( 10 mg/day ) therapy were randomized to a 30 - or 60-mg reload of prasugrel .
METHODS	The platelet reactivity index ( PRI ) , as assessed by whole-blood vasodilator-stimulated phosphoprotein , was measured with and without in vitro incubation of cangrelor ( 500 nM ) at baseline , and at 1 and 4 h after reload .
RESULTS	In the absence of cangrelor , prasugrel reloading reduced PRI ( p < 0.001 for both doses ) , although a 60-mg reload had greater platelet inhibition compared with a 30-mg reload at 4 h ( p = 0.001 ) .
RESULTS	Cangrelor was associated with a reduction in PRI values during the overall study time course in patients reloaded with 30 mg ( p = 0.001 ) and 60 mg ( p < 0.001 ) of prasugrel .
RESULTS	In patients reloaded with 30 mg prasugrel , cangrelor decreased PRI at each time point ( baseline , p < 0.001 ; 1 h , p = 0.013 ; 4 h , p = 0.001 ) .
RESULTS	In patients reloaded with 60 mg prasugrel , cangrelor decreased PRI at baseline ( p < 0.001 ) and 1 h ( p = 0.002 ) ; levels of platelet reactivity comparable to those achieved with cangrelor were observed only at 4 h ( p = 0.325 ) .
RESULTS	The intergroup comparisons with cangrelor were not significant at any time point .
CONCLUSIONS	In patients on maintenance prasugrel therapy exposed to a reloading dose ( 30 or 60 mg ) of prasugrel , in vitro cangrelor is associated with further platelet P2Y12 receptor inhibitory effects .

###24886066
BACKGROUND	Point of care testing for C-reactive protein ( CRP ) has shown promise as a measure to reduce unnecessary antibiotic prescribing in respiratory tract infections ( RTI ) , but its use in primary care is still controversial .
BACKGROUND	We aimed to evaluate the effect of CRP testing on the prescription of antibiotics , referral for radiography , and the outcome of patients in general practice with acute cough/RTI .
METHODS	An open-cluster randomized clinical trial was conducted , with CRP testing performed in the intervention group .
METHODS	Antibiotic prescribing and referral for radiography were the main outcome measures .
RESULTS	A total of 179 patients were included : 101 in the intervention group and 78 in the control group .
RESULTS	The two groups were similar in clinical characteristics .
RESULTS	In the intervention group , the antibiotic prescribing rate was 37.6 % , which was significantly lower than that in the control group ( 58.9 % ) ( P = 0.006 ) .
RESULTS	Referral for chest X-ray was also significantly lower in the intervention group ( 55.4 % ) than in the control group ( 75.6 % ) ( P = 0.004 ) .
RESULTS	The recovery rate , as recorded by the GPs , was 92.9 % and 93.6 % in the intervention and control groups , respectively .
CONCLUSIONS	The study showed that CRP testing in patients with acute cough/RTI may reduce antibiotic prescribing and referral for radiography , probably without compromising recovery .
BACKGROUND	The trial was registered in the ClinicalTrials.gov Protocol Registration System ( identification number : NCT01794819 ) .

###24839882
OBJECTIVE	This study tested the effect of beginning treatment with a speech-generating device ( SGD ) in the context of a blended , adaptive treatment design for improving spontaneous , communicative utterances in school-aged , minimally verbal children with autism .
METHODS	A total of 61 minimally verbal children with autism , aged 5 to 8 years , were randomized to a blended developmental/behavioral intervention ( JASP+EMT ) with or without the augmentation of a SGD for 6 months with a 3-month follow-up .
METHODS	The intervention consisted of 2 stages .
METHODS	In stage 1 , all children received 2 sessions per week for 3 months .
METHODS	Stage 2 intervention was adapted ( by increased sessions or adding the SGD ) based on the child 's early response .
METHODS	The primary outcome was the total number of spontaneous communicative utterances ; secondary measures were the total number of novel words and total comments from a natural language sample .
RESULTS	Primary aim results found improvements in spontaneous communicative utterances , novel words , and comments that all favored the blended behavioral intervention that began by including an SGD ( JASP+EMT+SGD ) as opposed to spoken words alone ( JASP+EMT ) .
RESULTS	Secondary aim results suggest that the adaptive intervention beginning with JASP+EMT+SGD and intensifying JASP+EMT+SGD for children who were slow responders led to better posttreatment outcomes .
CONCLUSIONS	Minimally verbal school-aged children can make significant and rapid gains in spoken spontaneous language with a novel , blended intervention that focuses on joint engagement and play skills and incorporates an SGD .
CONCLUSIONS	Future studies should further explore the tailoring design used in this study to better understand children 's response to treatment .
CONCLUSIONS	Clinical trial registration information-Developmental and Augmented Intervention for Facilitating Expressive Language ( CCNIA ) ; http://clinicaltrials.gov/; NCT01013545 .

###24464572
OBJECTIVE	The purpose of this study was to refine a commercial car driving simulation for occupational research .
OBJECTIVE	As the effects of ethanol on driving behavior are well established , we choose alcohol as a test compound to investigate the performance of subjects during simulation .
METHODS	We programmed a night driving scenario consisting of monotonous highway and a rural road on a Foerst F10-P driving simulator .
METHODS	Twenty healthy men , 19-30 years , participated in a pilot study .
METHODS	Subjects were screened for simulator sickness , followed by training on the simulator one hour in total .
METHODS	Experiments were performed in the morning on a separate day .
METHODS	Participants were randomized into either an alcoholized or a control group .
METHODS	All subjects drove two courses consisting of highway and rural road and were sober for the first course .
METHODS	During a 1 h break the ethanol group drank an alcoholic beverage to yield 0.06 % blood alcohol concentration ( BAC ) .
METHODS	Generalized linear mixed models were used to analyze the influence of alcohol on driving performance .
METHODS	Among others , independent variables were Simulator Sickness Questionnaire scores and subjective sleepiness .
RESULTS	Subjects did not experience simulator sickness during the experiments .
RESULTS	Mean BAC before the second test drive was 0.065 % in the mildly intoxicated group .
RESULTS	There was no clear-cut difference in the number of crashes between 2 groups .
RESULTS	BAC of 0.1 % would deteriorate mean braking reaction time by 237 ms ( SE = 112 , p < 0.05 ) .
RESULTS	Ethanol slightly impaired the tracking in the right-hand curves ( p = 0.058 ) .
RESULTS	Braking reaction time improved by 86 ms ( SE = 36 , p < 0.05 ) for the second test drive , indicating a learning effect .
CONCLUSIONS	In sum , a clear ethanol effect was observed in the driving simulation .
CONCLUSIONS	This simulation seems suitable for occupational research and produces little simulator sickness .
CONCLUSIONS	Controlling for possible learning effects is recommended in driving simulation studies .

###25315664
OBJECTIVE	To determine the prognostic value of outer retinal tubulation ( ORT ) in the enlargement amount of geographic atrophy ( GA ) in eyes with age-related macular degeneration ( AMD ) .
METHODS	Cohort study .
METHODS	One hundred eight fellow untreated eyes of 143 patients with GA resulting from AMD enrolled in the MAHALO study ( clinicaltrials.gov identifier , NCT01229215 ) who completely satisfied the study term and had gradable spectral-domain optical coherence tomography ( OCT ) images obtained at both baseline and month 18 visits .
METHODS	The MAHALO study enrolled 143 subjects into a phase 1b/2 multicenter , randomized , single-masked , sham-injection controlled clinical trial of the safety , tolerability , and evidence of activity of lampalizumab in patients with GA associated with AMD .
METHODS	Spectral-domain optical coherence tomography images were obtained at multiple time points in both eyes , although only the baseline and month 18 data of the fellow ( nonstudy ) eyes were considered in this exploratory analysis .
METHODS	The Cirrus HD-OCT review software was used for automatic segmentation and measurement of GA areas , with manual correction of segmentation errors by certified OCT graders .
METHODS	Baseline OCT images also were assessed for the presence of ORT .
METHODS	The enlargement amount of GA in eyes with ORT was compared with that of eyes without ORT .
METHODS	Comparison of the enlargement amount of GA in eyes with and without ORT .
RESULTS	Twenty-four of these 108 eyes demonstrated evidence of ORT .
RESULTS	The amount of enlargement of GA in eyes with ORT was significantly slower than that of eyes without ORT ( 1.850.78 vs. 2.671.61 ; P = 0.001 ) .
RESULTS	This difference remained significant when considering subgroups with unifocal or multifocal GA lesions , because eyes with ORT in both subgroups had a slower enlargement amount of GA than eyes without ORT ( 2.911.70 vs. 2.080.88 [ P = 0.01 ] , in eyes with multifocal GA lesions ; and 2.241.40 vs. 1.630.57 [ P = 0.02 ] , in eyes with unifocal GA lesions ) .
CONCLUSIONS	In eyes with ORT , GA lesions seem to enlarge at a significantly slower rate than those of eyes without ORT .
CONCLUSIONS	The presence of ORT may need to be accounted for in longitudinal studies of GA. .

###24326106
OBJECTIVE	To compare the efficacy and safety of ranibizumab 0.5 mg , guided by visual acuity ( VA ) stabilization or disease activity criteria , versus verteporfin photodynamic therapy ( vPDT ) in patients with visual impairment due to myopic choroidal neovascularization ( CNV ) .
METHODS	Phase III , 12-month , randomized , double-masked , multicenter , active-controlled study .
METHODS	Patients ( N = 277 ) with visual impairment due to myopic CNV .
METHODS	Patients were randomized to receive ranibizumab on day 1 , month 1 , and thereafter as needed guided by VA stabilization criteria ( group I , n = 106 ) ; ranibizumab on day 1 and thereafter as needed guided by disease activity criteria ( group II , n = 116 ) ; or vPDT on day 1 and disease activity treated with ranibizumab or vPDT at investigators ' discretion from month 3 ( group III , n = 55 ) .
METHODS	Mean average best-corrected visual acuity ( BCVA ) change from baseline to month 1 through months 3 ( primary ) and 6 , mean BCVA change and safety over 12 months .
RESULTS	Ranibizumab treatment in groups I and II was superior to vPDT based on mean average BCVA change from baseline to month 1 through month 3 ( group I : +10.5 , group II : +10.6 vs. group III : +2.2 Early Treatment Diabetic Retinopathy Study [ ETDRS ] letters ; both P < 0.0001 ) .
RESULTS	Ranibizumab treatment guided by disease activity was noninferior to VA stabilization-guided retreatment based on mean average BCVA change from baseline to month 1 through month 6 ( group II : +11.7 vs. group I : +11.9 ETDRS letters ; P < 0.00001 ) .
RESULTS	Mean BCVA change from baseline to month 12 was +13.8 ( group I ) , +14.4 ( group II ) , and +9.3 ETDRS letters ( group III ) .
RESULTS	At month 12 , 63.8 % to 65.7 % of patients showed resolution of myopic CNV leakage .
RESULTS	Patients received a median of 4.0 ( group I ) and 2.0 ( groups II and III ) ranibizumab injections over 12 months .
RESULTS	No deaths or cases of endophthalmitis and myocardial infarction occurred .
CONCLUSIONS	Ranibizumab treatment , irrespective of retreatment criteria , provided superior BCVA gains versus vPDT up to month 3 .
CONCLUSIONS	Ranibizumab treatment guided by disease activity criteria was noninferior to VA stabilization criteria up to month 6 .
CONCLUSIONS	Over 12 months , individualized ranibizumab treatment was effective in improving and sustaining BCVA and was generally well tolerated in patients with myopic CNV .

###24738793
BACKGROUND	Widespread psoriasis has great effects on life .
BACKGROUND	Effective and rapid response in the treatment is needed .
BACKGROUND	So this study was done to compare the efficacy of combined narrowband ultraviolet-B ( NBUVB ) plus methotrexate ( MTX ) versus each one alone in the treatment of psoriasis .
METHODS	A total of 120 patients with widespread plaque-type psoriasis were enrolled , but only 113 patients completed the study .
METHODS	They were divided into three groups randomly , group MN ( 38 ) received NBUVB plus MTX , group N ( 38 ) received NBUVB alone , and group M ( 37 ) received MTX only .
METHODS	End point of treatment ( clearance ) was 90 % reduction in Psoriasis Area and Severity Index ( PASI ) Score or up to six months , whichever was earlier ; follow-up was done for one year .
RESULTS	The mean number of weeks required for achieving clearance was 6.11 1.28 weeks in group MN , 11.42 2.36 weeks in group N , and 20.87 4.21 weeks in group M ( P < 0.0001 ) .
RESULTS	The mean number of phototherapy sessions was 17.86 3.74 sessions in group MN , and 33.51 6.9 sessions in group N ( P < 0.0001 ) .
RESULTS	The mean total cumulative dose of NBUVB for achieving clearance was 12.13 4.02 J/cm ( 2 ) in group MN , compared with 34.48 13.13 J/cm ( 2 ) in group N ( P < 0.0001 ) , while the mean total cumulative dose of MTX was 116.04 20.47 mg in group MN compared with 298.63 60.26 mg in group M ( P < 0.0001 ) .
CONCLUSIONS	Combination of NBUVB plus MTX provided rapid improvement with less cumulative doses of both therapies compared with each one alone in the treatment of psoriasis .

###25497243
BACKGROUND	A number of investigative strategies exist for the diagnosis of coronary heart disease ( CHD ) .
BACKGROUND	Despite the widespread availability of noninvasive imaging , invasive angiography is commonly used early in the diagnostic pathway .
BACKGROUND	Consequently , approximately 60 % of angiograms reveal no evidence of obstructive coronary disease .
BACKGROUND	Reducing unnecessary angiography has potential financial savings and avoids exposing the patient to unnecessary risk .
BACKGROUND	There are no large-scale comparative effectiveness trials of the different diagnostic strategies recommended in international guidelines and none that have evaluated the safety and efficacy of cardiovascular magnetic resonance .
METHODS	CE-MARC 2 is a prospective , multicenter , 3-arm parallel group , randomized controlled trial of patients with suspected CHD ( pretest likelihood 10 % -90 % ) requiring further investigation .
METHODS	A total of 1,200 patients will be randomized on a 2:2:1 basis to receive 3.0-T cardiovascular magnetic resonance-guided care , single-photon emission computed tomography-guided care ( according to American College of Cardiology/American Heart Association appropriate-use criteria ) , or National Institute for Health and Care Excellence guidelines-based management .
METHODS	The primary ( efficacy ) end point is the occurrence of unnecessary angiography as defined by a normal ( > 0.8 ) invasive fractional flow reserve .
METHODS	Safety of each strategy will be assessed by 3-year major adverse cardiovascular event rates .
METHODS	Cost-effectiveness and health-related quality-of-life measures will be performed .
CONCLUSIONS	The CE-MARC 2 trial will provide comparative efficacy and safety evidence for 3 different strategies of investigating patients with suspected CHD , with the intension of reducing unnecessary invasive angiography rates .
CONCLUSIONS	Evaluation of these management strategies has the potential to improve patient care , health-related quality of life , and the cost-effectiveness of CHD investigation .

###25127988
OBJECTIVE	To determine if an abnormal CA-125 level in a menopausal female without ovarian cancer is associated with an increase in mortality .
METHODS	The Prostate , Lung , Colorectal , and Ovarian Cancer Screening Randomized Controlled ( PLCO ) Trial is a large multicenter prospective trial conducted by the National Cancer Institute ( NCI ) .
METHODS	Over 78,000 healthy women aged 55-74 were randomized to a screening arm versus a usual medical care arm to evaluate the efficacy of screening in reducing mortality due to ovarian cancer .
METHODS	Women in the screening arm underwent annual screening for ovarian cancer with transvaginal ultrasound and CA-125 levels .
METHODS	There were 38,818 patients without ovarian cancer that had at least one CA-125 level drawn ; 1201 ( 3.09 % ) had at least one abnormal level .
METHODS	The current study compares mortality in patients that had one or more abnormal CA-125 levels without ovarian cancer versus those with all normal levels .
RESULTS	Patients with one or more abnormal CA-125 levels , without ovarian cancer , had a significantly higher mortality than patients with all normal CA-125 levels in the PLCO screening trial ( p < 0.0001 ) .
RESULTS	This increased risk extended throughout the follow-up period .
RESULTS	Analysis of cause of death listed on the death certificate showed an excess mortality attributable to lung cancer , digestive disease , and endocrine , nutritional , and metabolic disease .
CONCLUSIONS	Menopausal females with an elevated CA-125 and without ovarian cancer are exposed to an increased risk of premature mortality .

###24412468
BACKGROUND	Cariprazine is an orally active and potent D3 and D2 partial agonist with preferential binding to D3 receptors in development for the treatment of schizophrenia and bipolar mania .
BACKGROUND	This study ( NCT00694707 ) evaluated the efficacy and safety of cariprazine in patients with acute exacerbation of schizophrenia .
METHODS	This study was a multinational , double-blind , randomized , placebo - and active-controlled , fixed-dose trial .
METHODS	Patients were randomized to receive placebo , cariprazine 1.5 mg/d , cariprazine 3.0 mg/d , cariprazine 4.5 mg/d , or risperidone 4.0 mg/d ( for assay sensitivity ) for 6 weeks of double-blind treatment and 2 weeks of safety follow-up .
METHODS	Primary and secondary efficacy parameters were change from baseline to Week 6 in Positive and Negative Syndrome Scale ( PANSS ) total and Global Impressions-Severity of Illness ( CGI-S ) scores , respectively .
METHODS	Safety parameters included adverse events ( AEs ) , vital signs , laboratory measures , and extrapyramidal symptom ( EPS ) scales .
RESULTS	Of 732 randomized patients , 64 % completed the study .
RESULTS	PANSS total score improvement at Week 6 was statistically significant versus placebo for cariprazine 1.5 mg/d , 3.0 mg/d , and 4.5 mg/d ( least squares mean difference [ LSMD ] : -7.6 , -8.8 , -10.4 , respectively ; p < 0.001 ; LOCF ) and risperidone ( -15.1 , p < 0.001 ; LOCF ) ; significant improvement on CGI-S was demonstrated for all active treatments ( p < 0.05 ) .
RESULTS	The most frequent cariprazine AEs ( 5 % and at least twice the rate of the placebo group ) were insomnia , extrapyramidal disorder , akathisia , sedation , nausea , dizziness , and constipation .
RESULTS	Mean changes in metabolic parameters were small and similar between groups .
CONCLUSIONS	The results of this study support the efficacy and safety of cariprazine in patients with acute exacerbation of schizophrenia .

###25628308
OBJECTIVE	Limited data exists regarding the relationship between left ventricular systolic dysfunction ( LVSD ) and heart failure ( HF ) symptoms and embolic risk among patients with atrial fibrillation .
METHODS	Participants in the Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events ( ACTIVE ) trials with HF , but not randomized to oral anticoagulation , were categorized as having preserved versus reduced ejection fraction .
METHODS	If reduced , LVSD was classified as mild , moderate , or severe .
METHODS	Symptoms were quantified using New York Heart Association class.The primary outcome was a composite of stroke , transient ischemic attack , and systemic embolism .
RESULTS	There were 3487 antiplatelet-treated patients with HF at baseline .
RESULTS	Of these patients , 969 ( 46.8 % ) had HF with preserved ejection fraction and 1103 ( 53.2 % ) had HF with reduced ejection fraction .
RESULTS	During 3.6 years of mean follow-up , first occurrence of stroke , transient ischemic attack , or systemic embolism occurred in 386 patients.The strongest independent predictors of embolic events were age 75 years ( hazard ratio 2.55 ; confidence interval , 1.85-3 .53 ) , prior stroke or transient ischemic attack ( hazard ratio 2.07 ; 95 % confidence interval , 1.65-2 .60 ) , and female sex ( hazard ratio 1.37 ; confidence interval , 1.11-1 .69 ) .
RESULTS	However , ejection fraction < 0.50 , degree of LVSD , and New York Heart Association class did not predict embolic events .
RESULTS	Patients with HF with preserved ejection fraction exhibited similar risk of embolic events as those with HR with reduced ejection fraction : 4.3 % versus 4.4 % per 100 person-years ( hazard ration 1.01 ; 95 % confidence interval , 0.78-1 .31 ) .
RESULTS	Risk of embolic events was similar across categories of LVSD ( P for trend = 0.96 ) and New York Heart Association class ( P for trend = 0.57 ) .
CONCLUSIONS	Among HF patients in ACTIVE , neither the presence of LVSD or degree of symptom severity influenced risk of embolic events .

###24239019
BACKGROUND	We previously have shown that buttonhole needling is associated with a reduction in hematoma and postulated that buttonhole needling may increase long-term survival of an arteriovenous fistula ( AVF ) .
BACKGROUND	The purpose of this study was to evaluate AVF survival and complications in buttonhole versus standard needling .
METHODS	Long-term follow up of a randomized controlled trial in which participants were randomly assigned to standard or buttonhole needling and followed up until the AVF was abandoned or the study end date .
METHODS	140 long-term hemodialysis patients in Calgary , Alberta .
METHODS	Buttonhole needling with median time of exposure to the intervention of 13.2 ( IQR , 7.8-19 .4 ) months .
METHODS	Patients were prospectively followed up for study outcomes .
METHODS	Median follow-up times were 17.2 ( IQR , 11.9-37 .8 ) and 19.2 ( IQR , 12.5-41 .0 ) months for standard and buttonhole needling , respectively ( P = 0.2 ) .
METHODS	The primary outcome was median access survival in months .
METHODS	Other outcomes included assisted and unassisted patency rates , rates of surgical and radiologic interventions , and time to abandonment ( months ) of buttonhole .
RESULTS	Baseline characteristics were similar .
RESULTS	The primary outcome , median access survival , was similar inboth groups : 16.0 ( IQR , 10.6-29 .3 ) and 18.4 ( IQR , 10.9-32 .7 ) months for standard and buttonhole needling , respectively ( P = 0.2 ) .
RESULTS	There were 7 ( 10.1 % ) and 6 ( 8.6 % ) thromboses with standard and buttonhole needling , respectively ( P = 0.6 ) .
RESULTS	Median fistulogram rates were similar between techniques ( P = 0.2 with intention-to-treat analysis ) .
RESULTS	Most patients ( 46 of 70 ) abandoned buttonhole needling by a median of 11.3 ( IQR , 4.8-18 .2 ) months .
RESULTS	Median time to first infection for buttonhole needling was 11.1 ( IQR , 4.9-30 .0 ) months .
RESULTS	There were no infections in standard needling of AVFs .
CONCLUSIONS	Findings are limited to patients needled by multiple hemodialysis nurses and not applicable to self-needlers .
CONCLUSIONS	AVFs with buttonhole needling did not have improved survival .
CONCLUSIONS	The lack of survival benefit and higher risk of infection should be noted when promoting buttonhole needling .

###24310343
OBJECTIVE	The Age-Related Eye Disease Study ( AREDS ) formulation for the treatment of age-related macular degeneration ( AMD ) contains vitamin C , vitamin E , beta carotene , and zinc with copper .
OBJECTIVE	The Age-Related Eye Disease Study 2 ( AREDS2 ) assessed the value of substituting lutein/zeaxanthin in the AREDS formulation because of the demonstrated risk for lung cancer from beta carotene in smokers and former smokers and because lutein and zeaxanthin are important components in the retina .
OBJECTIVE	To further examine the effect of lutein/zeaxanthin supplementation on progression to late AMD .
METHODS	The Age-Related Eye Disease Study 2 is a multicenter , double-masked randomized trial of 4203 participants , aged 50 to 85 years , at risk for developing late AMD ; 66 % of patients had bilateral large drusen and 34 % had large drusen and late AMD in 1 eye .
METHODS	In addition to taking the original or a variation of the AREDS supplement , participants were randomly assigned in a factorial design to 1 of the following 4 groups : placebo ; lutein/zeaxanthin , 10 mg/2 mg ; omega-3 long-chain polyunsaturated fatty 3 acids , 1.0 g ; or the combination .
METHODS	S Documented development of late AMD by central , masked grading of annual retinal photographs or by treatment history .
METHODS	RESULTS In exploratory analysis of lutein/zeaxanthin vs no lutein/zeaxanthin , the hazard ratio of the development of late AMD was 0.90 ( 95 % CI , 0.82-0 .99 ; P = .04 ) .
METHODS	Exploratory analyses of direct comparison of lutein/zeaxanthin vs beta carotene showed hazard ratios of 0.82 ( 95 % CI , 0.69-0 .96 ; P = .02 ) for development of late AMD , 0.78 ( 95 % CI , 0.64-0 .94 ; P = .01 ) for development of neovascular AMD , and 0.94 ( 95 % CI , 0.70-1 .26 ; P = .67 ) for development of central geographic atrophy .
METHODS	In analyses restricted to eyes with bilateral large drusen at baseline , the direct comparison of lutein/zeaxanthin vs beta carotene showed hazard ratios of 0.76 ( 95 % CI , 0.61-0 .96 ; P = .02 ) for progression to late AMD , 0.65 ( 95 % CI , 0.49-0 .85 ; P = .002 ) for neovascular AMD , and 0.98 ( 95 % CI , 0.69-1 .39 ; P = .91 ) for central geographic atrophy .
CONCLUSIONS	The totality of evidence on beneficial and adverse effects from AREDS2 and other studies suggests that lutein/zeaxanthin could be more appropriate than beta carotene in the AREDS-type supplements .
BACKGROUND	clinicaltrials.gov Identifier : NCT00345176 .

###24569129
OBJECTIVE	QVA149 is a dual bronchodilator , containing a fixed-dose combination of the long-acting 2-agonist indacaterol and long-acting muscarinic antagonist glycopyrronium , for the treatment of chronic obstructive pulmonary disease ( COPD ) .
OBJECTIVE	Here we assess the potential of QVA149 ( 440/200 g ) at 4-fold the therapeutic dose for causing cardiac pharmacodynamic ( PD ) effects .
METHODS	This double-blind , randomized study estimated the time-matched largest heart rate ( HR ) change and average HR change ( over 24 hours ) from baseline for QVA149 vs. placebo in healthy subjects .
METHODS	Similar analyses were done for QVA149 vs. indacaterol 600 g , glycopyrronium 200 g , and salmeterol 200 g.
METHODS	The time-matched and average change from baseline in QT interval corrected for HR using Fridericia 's formula ( QTcF ) , effects on serum potassium and blood glucose , pharmacokinetic ( PK ) parameters , and safety were also assessed .
RESULTS	Of 50 subjects randomized , 43 completed the study .
RESULTS	QVA149 , when compared with placebo , showed the time-matched largest mean increase and decrease in HR of 5.69 bpm and -2.51 bpm , respectively , and average HR change from baseline of 0.62 bpm .
RESULTS	QVA149 showed no tachycardic potential compared with indacaterol and no relevant tachycardic effect compared with glycopyrronium .
RESULTS	No consistent differences were seen in the time-matched largest mean change and average change from baseline in QTcF for QVA149 vs. other treatments .
RESULTS	There were no relevant effects of QVA149 on serum potassium and blood glucose .
RESULTS	There was no apparent PK/PD relationship between the observed exposures to indacaterol and glycopyrronium in QVA149 on HR and QTcF .
RESULTS	There were no deaths or serious adverse events .
CONCLUSIONS	Overall , short-term administration of QVA149 showed a good cardiovascular safety and tolerability profile in healthy subjects .

###25022130
OBJECTIVE	To observe the effects of navel-warming therapy on clinical efficacy in patients with yang-deficiency tympanites based on regular treatment of western medication .
METHODS	One hundred and twenty cases of yang-deficiency tympanites were randomly divided into a navel-warming therapy group and a western medication group , sixty cases in each one .
METHODS	The regular treatment of western medicine was applied in the western medication group , including oral administration of antiviral drug and diuretics as well as intravenous drip of hepatic protector .
METHODS	Based on western medicine treatment , the navel-warming therapy was applied in the navel-warming group .
METHODS	A medical cake was laid on Shenque ( CV 8 ) , and then a medical cylinder was placed above the medical cake and ignited .
METHODS	The treatment was given once daily .
METHODS	One month was considered as a treatment session in both groups and totally one session was required .
METHODS	The TCM symptom score , B-ultrasound ascites and temporary use of diuretics before and after treatment were observed in both groups ; also the efficacy was evaluated .
RESULTS	The total effective rate was 81.7 % ( 49/60 ) in the navel-warming therapy group , which was superior to 56.7 % ( 34/60 ) in the western medication group ( P < 0.05 ) .
RESULTS	After the treatment , the TCM symptom score and ascites were improved in both groups ( all P < 0.05 ) , which was more significant in the navel-warming therapy group ( all P < 0.05 ) .
RESULTS	The temporary use of diuretics was statistically different between the two groups ( P < 0.05 ) , indicating the navel-warming therapy group could obviously reduce or stop the use of diuretics .
CONCLUSIONS	Based on regular treatment of western medication , the navel-warming therapy could significantly improve therapeutic efficacy , effectively relieve clinical symptoms and ease ascites .

###24349532
BACKGROUND	The purpose of this study was to identify gene polymorphisms of interleukin-18 ( IL-18 ) -607 A/C and -137 G/C specific to patients with oral cancer susceptibility and clinicopathological status .
RESULTS	A total of 1,126 participants , including 559 healthy people and 567 patients with oral cancer , were recruited for this study .
RESULTS	Allelic discrimination of -607 A/C ( rs1946518 ) and -137 G/C ( rs187238 ) polymorphisms of the IL-18 gene was assessed by a real-time PCR with the TaqMan assay .
RESULTS	There was no significant association between IL-18 -607 A/C polymorphism and oral cancer risk .
RESULTS	However , among alcohol consumers , people with A/A homozygotes of IL-18 -607 A/C polymorphism had a 2.38-fold ( 95 % CI = 1.17-4 .86 ; p = 0.01 ) increased risk of developing oral cancer compared with those with C/C homozygotes .
RESULTS	The participants with G/C heterozygotes of IL-18 -137 polymorphism had a 1.64-fold ( 95 % CI : 1.08-2 .48 ; p = 0.02 ) increased risk of developing oral cancer compared with those with G/G wild type homozygotes .
RESULTS	Both sets of statistics were determined after adjusting for confounding factors .
RESULTS	Among people who had exposure to oral cancer-related environmental risk factors such as areca , alcohol , and tobacco consumption , the adjusted odd ratios and 95 % confidence intervals were increased to a 2.02-fold ( 95 % CI = 1.01-4 .04 ; p = 0.04 ) , 4.04 ( 95 % CI = 1.65-9 .87 ; p = 0.002 ) and a 1.66-fold ( 95 % CI = 1.00-2 .84 ; p = 0.05 ) risk of developing oral cancer .
RESULTS	However , patients with G/C alleles of IL-18 -137 were correlated with a lower clinical stage ( AOR = 0.59 ; 95 % CI = 0.39-0 .89 ; p = 0.01 ) , smaller tumor size ( AOR = 0.56 ; 95 % CI = 0.35-0 .87 ; p = 0.01 ) , and non-lymph node metastasis ( AOR = 0.51 ; 95 % CI = 0.32-0 .80 ; p = 0.003 ) .
CONCLUSIONS	IL-18 -137 G/C gene polymorphism may be a factor that increases the susceptibility to oral cancer , as well as a protective factor for oral cancer progression .
CONCLUSIONS	The interactions of gene to oral cancer-related environmental risk factors have a synergetic effect that can further enhance oral cancer development .

###24988874
BACKGROUND	Exact mechanism of causation of chronic kidney disease of unknown etiology ( CKDu ) in Sri Lanka is not described to date , despite the identification of possible multiple risk factors .
BACKGROUND	Questions have been raised as to why only some are affected while others remain intact , though they are inhabitants of the same locality .
METHODS	Comparative studies were carried out , assessing urinary 2 microglobulin ( 2m ) and the dietary patterns of CKDu patients and age sex matched non-CKDu subjects .
METHODS	Urinary 2m levels of spot urine samples were analyzed using the Enzyme-linked Immunosorbent assay ( ELISA ) and dietary patterns were studied using twenty four hour dietary recalls and frequency consumption of foods of animal origin performed on three occasions at six months intervals within a period of one and half years .
RESULTS	The mean urinary 2m level of CKDu patients from Medawachchiya was significantly ( p < 0.05 ) higher when compared with that of the non-CKDu subjects .
RESULTS	The mean urinary 2m level of the non-CKDu subjects was within the reference limits for spot urine samples ( 0 - 0.3 g/mL ) .
RESULTS	White raw rice was the staple diet of both CKDu patients and non-CKDu subjects and the level of consumption was almost the same .
RESULTS	The consumption of fresh water fish products of CKDu patients under high ( 14 , 14 % ) , moderate ( 36 , 36 % ) , low ( 26 , 26 % ) and less ( 20 , 20 % ) categories did not show significant variations ( p > 0.05 ) compared to non-CKDu subjects .
CONCLUSIONS	Staple food in diet and the consumption pattern of CKDu patients from Medawachchiya were similar to that of non-CKDu subjects from the same area despite their urinary 2m concentration being significantly higher .

###25176098
OBJECTIVE	To assess efficacy of membrane peeling combined with intravitreal injection of bevacizumab in the treatment of macular epiretinal membrane .
METHODS	From January , 2012 to June , 2013 , 33 patients ( 33 eyes ) with the diagnosis of macular epiretinal membrane underwent vitreous surgery and membrane peeling .
METHODS	The patients were randomly divided into intravitreal bevacizumab group ( IVB group ) and non-intravitreal bevacizumab group ( non-IVB group ) .
METHODS	All the patients underwent standard three-port vitrectomy and peeling of epiretinal membrane , with intravitreal injection of 1.5 mg bevacizumab at the end of operation in IVB group .
METHODS	The best corrected visual acuity and optical coherence tomography ( OCT ) were examined before and after the treatment .
METHODS	The patients were followed up for 3-14 months ( mean 6.5 months ) .
RESULTS	Macular epiretinal membranes were successfully peeled during operation in all the patients without postoperative intraocular infection or bleeding .
RESULTS	Fifteen eyes received vitrectomy combined with intravitreal injection of bevacizumab , and 18 underwent only vitreous operation and membrane peeling .
RESULTS	At the end of the follow up , the visual acuity improved in 11 eyes ( 73.3 % ) in IVB group , as compared to 13 eyes ( 72.2 % ) in the non-IVB group ( P = 0.627 ) .
RESULTS	Central macular thickness decreased by 14362 m in IVB group and by 9628 m in non-IVB group , showing a significant difference between the two groups ( t = 5.564 , P < 0.01 ) .
CONCLUSIONS	Vitrectomy and membrane peeling combined with intravitreal injection of bevacizumab can promote the recovery of macular morphology but not visual function , and its clinical use still needs to be tested in a long-term and large-sample randomized controlled study .

###26436182
BACKGROUND	Alcohol consumption is common on college campuses and is associated with negative consequences .
BACKGROUND	Factors associated with availability of alcohol are not completely understood .
OBJECTIVE	To describe how proximity and density of alcohol outlets are associated with any drinking and binge drinking in students at the University of Wisconsin-Madison .
METHODS	Participants were full-time students enrolled in the Young Adults Eating and Active for Health , a multisite , randomized intervention that assessed a variety of health behaviors .
METHODS	Geographic information systems were used to calculate proximity and enumerate alcohol outlet densities .
METHODS	Participants were categorized as `` drinkers '' or `` nondrinkers '' based on self-reported alcohol consumption .
METHODS	Binge drinking was categorized as `` non-binge drinker , '' `` frequent binge drinker , '' and `` excessive binge drinker . ''
METHODS	Analysis included regression , t tests , and chi-square tests .
METHODS	RESULTS .
METHODS	Among the 166 participants , 126 ( 76 % ) were drinkers .
METHODS	Among drinkers , 80 ( 63 % ) were either frequent or excessive binge drinkers .
METHODS	Drinkers lived closer to an alcohol outlet than non-drinkers ( 0.18 + / - 0.15 vs. 0.61 + / - 1.59 miles , respectively , P = 0.005 ) .
METHODS	Within a 1-mile walking radius , there were 47 % more establishments for drinkers ( 153 + / - 47 compared to 104 + / - 55 outlets for nondrinkers , P < 0.0001 ) .
METHODS	At distances of 0.10-0 .25 and 0.25-0 .50 miles , twice as many outlets were available to drinkers ( 19 + / - 19 and 43 + / - 25 , respectively ) compared to nondrinkers ( 7 + / - 11 and 20 + / - 22 , respectively ) , P < 0.001 .
METHODS	Proximity and density were hot associated with binge drinking frequency .
CONCLUSIONS	Drinkers lived closer to alcohol outlets and had significantly more outlets available at a distance of up to 1 mile .
CONCLUSIONS	Municipal and college administrators could consider limiting alcohol license distributions in municipalities with high alcohol consumption .

###26172895
OBJECTIVE	Hyperkalemia is a potentially life-threatening condition predominantly seen in patients treated with renin-angiotensin-aldosterone system ( RAAS ) inhibitors with stage 3 or greater chronic kidney disease ( CKD ) who may also have diabetes , heart failure , or both .
OBJECTIVE	To select starting doses for a phase 3 study and to evaluate the long-term safety and efficacy of a potassium-binding polymer , patiromer , in outpatients with hyperkalemia .
METHODS	Phase 2 , multicenter , open-label , dose-ranging , randomized clinical trial ( AMETHYST-DN ) , conducted at 48 sites in Europe from June 2011 to June 2013 evaluating patiromer in 306 outpatients with type 2 diabetes ( estimated glomerular filtration rate , 15 to < 60 mL/min/1 .73 m2 and serum potassium level > 5.0 mEq/L ) .
METHODS	All patients received RAAS inhibitors prior to and during study treatment .
METHODS	Patients were stratified by baseline serum potassium level into mild or moderate hyperkalemia groups and received 1 of 3 randomized starting doses of patiromer ( 4.2 g [ n = 74 ] , 8.4 g [ n = 74 ] , or 12.6 g [ n = 74 ] twice daily [ mild hyperkalemia ] or 8.4 g [ n = 26 ] , 12.6 g [ n = 28 ] , or 16.8 g [ n = 30 ] twice daily [ moderate hyperkalemia ] ) .
METHODS	Patiromer was titrated to achieve and maintain serum potassium level 5.0 mEq/L or lower .
METHODS	The primary efficacy end point was mean change in serum potassium level from baseline to week 4 or prior to initiation of dose titration .
METHODS	The primary safety end point was adverse events through 52 weeks .
METHODS	Secondary efficacy end points included mean change in serum potassium level through 52 weeks .
RESULTS	A total of 306 patients were randomized .
RESULTS	The least squares mean reduction from baseline in serum potassium level at week 4 or time of first dose titration in patients with mild hyperkalemia was 0.35 ( 95 % CI , 0.22-0 .48 ) mEq/L for the 4.2 g twice daily starting-dose group , 0.51 ( 95 % CI , 0.38-0 .64 ) mEq/L for the 8.4 g twice daily starting-dose group , and 0.55 ( 95 % CI , 0.42-0 .68 ) mEq/L for the 12.6 g twice daily starting-dose group .
RESULTS	In those with moderate hyperkalemia , the reduction was 0.87 ( 95 % CI , 0.60-1 .14 ) mEq/L for the 8.4 g twice daily starting-dose group , 0.97 ( 95 % CI , 0.70-1 .23 ) mEq/L for the 12.6 g twice daily starting-dose group , and 0.92 ( 95 % CI , 0.67-1 .17 ) mEq/L for the 16.8 g twice daily starting-dose group ( P < .001 for all changes vs baseline by hyperkalemia starting-dose groups within strata ) .
RESULTS	From week 4 through week 52 , statistically significant mean decreases in serum potassium levels were observed at each monthly point in patients with mild and moderate hyperkalemia .
RESULTS	Over the 52 weeks , hypomagnesemia ( 7.2 % ) was the most common treatment-related adverse event , mild to moderate constipation ( 6.3 % ) was the most common gastrointestinal adverse event , and hypokalemia ( < 3.5 mEq/L ) occurred in 5.6 % of patients .
CONCLUSIONS	Among patients with hyperkalemia and diabetic kidney disease , patiromer starting doses of 4.2 to 16.8 g twice daily resulted in statistically significant decreases in serum potassium level after 4 weeks of treatment , lasting through 52 weeks .
BACKGROUND	clinicaltrials.gov Identifier : NCT01371747 .

###24645671
BACKGROUND	Preterm infants are at risk for adverse neurodevelopment .
BACKGROUND	Furthermore , nutrition may play a key role in supporting neurodevelopment .
BACKGROUND	The aim of this study was to evaluate whether a nutrient-enriched formula fed to preterm infants after hospital discharge could improve their neurodevelopment at 24 months ( term-corrected age ) .
METHODS	We conducted an observer-blinded , single-center , randomized controlled trial in infants admitted to the Fondazione IRCCS C Granda Ospedale Maggiore Policlinico , University of Milan , Italy between 2009 and 2011 .
METHODS	Inclusion criteria were gestational age < 32 weeks and/or birth weight < 1500 g , and being fed human milk for < 20 % of the total milk intake .
METHODS	Exclusion criteria were congenital malformations or conditions that could interfere with growth or body composition .
METHODS	Included infants were randomized to receive a standard full-term formula or a nutrient-enriched formula up until 6 months of corrected age , using two computer-generated randomization lists ; one appropriate for gestational age ( AGA ) and one for small for gestational age ( SGA ) infants .
METHODS	We assessed neurodevelopment at 24 months of corrected age using the Griffiths Mental Development Scale and related subscales ( locomotor , personal-social , hearing and speech , hand and eye coordination , and performance ) .
RESULTS	Of the 207 randomized infants , 181 completed the study .
RESULTS	52 AGA and 35 SGA infants were fed a nutrient-enriched formula , whereas 56 AGA and 38 SGA infants were fed a standard full-term formula .
RESULTS	The general quotient at 24 months of corrected age was not significantly different between infants randomized to receive a nutrient-enriched formula compared with a standard term formula up until 6 months of corrected age ( AGA infants : 93.8 12.6 vs. 92.4 10.4 , respectively ; SGA infants : 96.1 9.9 vs. 98.2 9 , respectively ) .
RESULTS	The scores of related subscales were also similar among groups .
CONCLUSIONS	This study found that feeding preterm infants a nutrient-enriched formula after discharge does not affect neurodevelopment at 24 months of corrected age , in either AGA or SGA infants , free from major comorbidities .
BACKGROUND	Current Controlled Trials ( http://www.controlled-trials.com/ISRCTN30189842 ) London , UK .

###25121986
OBJECTIVE	The primary purpose of this randomized controlled trial ( RCT ) was to evaluate the efficacy of internet-based problem-solving training ( iPST ) for employees in the educational sector ( teachers ) with depressive symptoms .
OBJECTIVE	The results of training were compared to those of a waitlist control group ( WLC ) .
METHODS	One-hundred and fifty teachers with elevated depressive symptoms ( Center for Epidemiologic Studies Depression Scale , CES-D 16 ) were assigned to either the iPST or WLC group .
METHODS	The iPST consisted of five lessons , including problem-solving and rumination techniques .
METHODS	Symptoms were assessed before the intervention began and in follow-up assessments after seven weeks , three months , and six months .
METHODS	The primary outcome was depressive symptom severity ( CES-D ) .
METHODS	Secondary outcomes included general and work-specific self-efficacy , perceived stress , pathological worries , burnout symptoms , general physical and mental health , and absenteeism .
RESULTS	iPST participants displayed a significantly greater reduction in depressive symptoms after the intervention ( d = 0.59 , 95 % CI 0.26-0 .92 ) , after three months ( d = 0.37 , 95 % CI 0.05-0 .70 ) and after six months ( d = 0.38 , 95 % CI 0.05-0 .70 ) compared to the control group .
RESULTS	The iPST participants also displayed significantly higher improvements in secondary outcomes .
RESULTS	However , workplace absenteeism was not significantly affected .
CONCLUSIONS	iPST is effective in reducing symptoms of depression among teachers .
CONCLUSIONS	Disseminated on a large scale , iPST could contribute to reducing the burden of stress-related mental health problems among teachers .
CONCLUSIONS	Future studies should evaluate iPST approaches for use in other working populations .

###24633272
OBJECTIVE	Anaemia is a major cardiovascular risk factor in chronic kidney disease ( CKD ) .
OBJECTIVE	Treatment and correction of anaemia leads to improvement of cardiovascular status and quality of life of patients with CKD .
OBJECTIVE	This interventional open labeled randomised controlled study comparing the effect of intravenous and oral iron therapy in improving red cell indices and iron status in anaemic pre-dialysis Chronic Kidney Disease was carried out to determine iron status in anaemic pre-dialysis CKD patients to assess the benefit of parenteral iron supplementation as against empirical oral iron in CKD patients with iron deficiency .
METHODS	Sixty consecutive pre-dialysis chronic kidney disease patients attending the renal clinic over a six month period were screened .
METHODS	Forty - one subjects ( 68.3 % ) were found to be anaemic and were subsequently studied .
RESULTS	The ages of the patients ranged between 19 and 71 years with a mean age of 39 years .
RESULTS	The mean serum creatinine and mean creatinine clearance were 201.80 ( 70.25 ) ?
RESULTS	mol/L and 37.90 ( 12.17 ) ml/minute respectively .
RESULTS	The haematocrit concentration was found to correlate inversely with the level of serum creatinine and 56.1 % of the anaemic patients had iron deficiency .
RESULTS	The mean PCV rise in the intravenous iron group was 2.42 ( 1.98 ) % and this was statistically significant ( p = 0.002 ) while the mean PCV difference was 0.909 ( 0.94 ) % in the oral iron group .
RESULTS	Intravenously administered iron alone permitted anaemia correction in about one-third of these patients without any life threatening adverse drug event .
CONCLUSIONS	Anaemia is very common in the pre-dialysis CKD population and the prevalence of iron deficiency is high .
CONCLUSIONS	Intravenous iron supplementation is an effective and safe treatment for the anaemia in the pre-dialysis CKD patients .
CONCLUSIONS	Response to oral iron was poor .

###25252964
BACKGROUND	Conventional endotracheal intubation requires laryngoscopy for a direct view of the glottis .
BACKGROUND	However , laryngoscopy is associated with many potential complications .
BACKGROUND	The aim of the present study was to compare the efficacy and safety of pyriform sinus localization-assisted blind orotracheal intubation with those of conventional laryngoscopic orotracheal intubation .
METHODS	A randomized , patient-blind , prospective study of 300 patients who underwent various operations was performed .
METHODS	One hundred patients were assigned to the laryngoscopic intubation group ( laryngoscopy group ) , and 200 patients were assigned to the blind intubation group ( blind group ) .
RESULTS	The total intubation success rate in the blind group was similar to that in the laryngoscopy group ( 100 % vs. 99 % , respectively ; p = 0.33 ) .
RESULTS	Oxygen saturation by pulse oximetry in both groups was maintained at > 98 % .
RESULTS	The intubation time was significantly shorter in the blind group than in the laryngoscopy group ( 9.73.4 s vs. 23.05.8 s , respectively ; p < 0.001 ) .
RESULTS	Postoperative complication rates were significantly lower in the blind group than in the laryngoscopy group .
RESULTS	Recovery time from these symptoms was significantly shorter in the blind group than in the laryngoscopy group ( p = 0.004 ) .
CONCLUSIONS	Pyriform sinus localization-assisted blind orotracheal intubation was shown to be more effective than conventional laryngoscopic orotracheal intubation in terms of success rate , intubation time , and postoperative complication rate .
CONCLUSIONS	Moreover , it is less affected by common risk factors ; thus , this method may be more beneficial in patients with difficult airways .

###25500324
OBJECTIVE	Most published contraceptive continuation rates have scientific limitations and can not be compared ; this is particularly true for dissimilar contraceptives .
OBJECTIVE	This study uses a new approach to determine if high continuation rates of long-acting reversible contraception ( LARC ) and protection from unintended pregnancy are observable in a population not self-selecting to use LARC .
METHODS	We are conducting a partially randomized patient preference trial ( PRPPT ) to compare continuation rates of short-acting reversible contraception ( SARC ) and LARC .
METHODS	Only women seeking SARC were invited to participate .
METHODS	Participants chose to be in the preference cohort ( self-selected method use ) or opted to be randomized to SARC or LARC ; only those in the randomized cohort received free product .
METHODS	We compared participant characteristics , reasons for not trying LARC previously and the contraceptive choices that were made .
RESULTS	We enrolled 917 eligible women ; 57 % chose to be in the preference cohort and 43 % opted for the randomized trial .
RESULTS	The preference and randomized cohorts were similar on most factors .
RESULTS	However , the randomized cohort was more likely than the preference cohort to be uninsured ( 48 % versus 36 % , respectively ) and to cite cost as a reason for not trying LARC previously ( 50 % versus 10 % ) ( p < .01 for both comparisons ) .
RESULTS	In the preference cohort , fear of pain/injury/side effects/health risks were the predominant reasons ( cited by over 25 % ) for not trying LARC previously ( p < .01 in comparison to randomized cohort ) .
CONCLUSIONS	Enrollment was successful and the process created different cohorts to compare contraceptive continuation rates and unintended pregnancy in this ongoing trial .
CONCLUSIONS	The choices participants made were associated with numerous factors ; lack of insurance was associated with participation in the randomized trial .
CONCLUSIONS	This PRPPT will provide new estimates of contraceptive continuation rates , such that any benefits of LARC will be more easily attributable to the technology and not the user .
CONCLUSIONS	Combined with measuring level of satisfaction with LARC , the results will help project the potential role and benefits of expanding voluntary use of LARC .

###25623312
OBJECTIVE	To explore the effect of pectin , a kind of soluble dietary fiber , on colonic transit time ( CTT ) , clinical symptoms and gut microbiota in adults with slow-transit constipation .
METHODS	A total of 80 patients with slow-transit constipation were selected between June 2011 and December 2013 .
METHODS	For this randomized controlled trial , we evaluated the efficacy of pectin on intestinal transit time and other indices of constipation in adults with slow-transit constipation .
METHODS	They were randomized to receive either pectin or placebo .
METHODS	Treatment consisted of 4-week supplementation with 24 g/d pectin ( fiber group ) or maltodextrin ( placebo group ) .
METHODS	Before and after 4-week treatment , CTT , constipation symptoms and fecal bacterial population were compared between groups .
RESULTS	CTT of the fiber group after treatment was lower than those of fiber group before treatment and those in the placebo group ( ( 60.2 11.2 ) h vs ( 80.3 9.5 ) , ( 79.4 11.7 ) h , P < 0.01 ) .
RESULTS	Constipation score of the fiber group after treatment also decreased than those of fiber group before treatment and those in the placebo group ( both P < 0.05 ) .
RESULTS	Bifidobacterium sp .
RESULTS	and Lactobacillus sp .
RESULTS	evidently increased ( lg copies/g :8.26 0.83 vs 6.42 1.07 and 6.48 0.82 , 6.83 0.77 vs 5.85 0.64 and 5.91 0.73 ; all P < 0.05 ) and total Clostridium sp .
RESULTS	significantly decreased ( 9.07 0.63 vs 9.74 0.81 and 9.66 0.43 , P < 0.05 ) in the fiber group after treatment versus the placebo group .
RESULTS	No significant adverse effects were reported .
CONCLUSIONS	Four-week soluble dietary fiber use accelerates colon transit time and alleviates clinical symptoms in patients with slow-transit constipation .
CONCLUSIONS	Additionally , supplementary fiber offers protective effects on gut microbiota by increasing the population of healthy microflora .

###25012003
OBJECTIVE	Recurrence rates of between 5 % and 25 % have been reported following surgery for chronic subdural hematoma ( CSH ) .
OBJECTIVE	A previous study showed that the treatment with angiotensin converting enzyme ( ACE ) inhibitors decreases the risk of recurrence .
OBJECTIVE	To test the effects of ACE inhibitors on the recurrence CSH and CSH remnant six weeks after surgery , we conducted a prospective double-blinded randomized controlled clinical trial on patients with CSHs from July 2009 until October 2012 .
METHODS	Patients eligible for burr hole surgery for CSH were randomized into either an ACE inhibitor perindopril 5mg or placebo treatment daily for three months prior to surgery .
METHODS	Cerebral CT scans were performed after six weeks , and clinical follow-ups were performed three months after surgery .
METHODS	Additionally , a retrospective analysis of the data and CT scans from all nonrandomized patients from the same time period was performed .
RESULTS	Forty-seven patients were included in the randomized study .
RESULTS	The patients ' preoperative Glasgow Coma Scale scores were 15 .
RESULTS	None of the patients in the randomized group developed a recurrence after surgery .
RESULTS	Measurements of the sizes of the CSH before and six weeks after surgery revealed no difference between the placebo and perindopril-treated groups .
RESULTS	In the retrospective group ( 245 patients ) , there was no correlation between the risk of recurrence and ACE inhibitor treatment .
CONCLUSIONS	Our data suggest that perindopril does not diminish the size of residual CSHs six weeks after burr hole surgery and that ACE inhibitors do not decrease the risk of CSH recurrence .

###25467955
BACKGROUND	Knee osteoarthritis ( OA ) progression has been linked to increased peak external knee adduction moments ( KAMs ) .
BACKGROUND	Although some trials have attempted to reduce pain and improve function in OA by reducing KAMs with a wedged footwear insole intervention , KAM reduction has not been specifically controlled for in trial designs , potentially explaining the mixed results seen in the literature .
BACKGROUND	Therefore , the primary purpose of this trial is to identify the effects of reduced KAMs on knee OA pain and function .
METHODS	Forty-six patients with radiographically confirmed diagnosis medial knee OA will be recruited for this 3 month randomized controlled trial .
METHODS	Recruitment will be from Alberta and surrounding areas .
METHODS	Eligibility criteria include being between the ages of 40 and 85 years , have knee OA primarily localized to the medial tibiofemoral compartment , based on the American College of Rheumatology diagnostic criteria and be classified as having a Kellgren-Lawrence grade of 1 to 3 .
METHODS	Patients will visit the laboratory at baseline for testing that includes dual x-ray absorptiometry , biomechanical testing , and surveys ( KOOS , PASE activity scale , UCLA activity scale , comfort visual analog scale ) .
METHODS	At baseline , patients will be randomized to either a wedged insole group to reduce KAMs , or a waitlist control group where no intervention is provided .
METHODS	The survey tests will be repeated at 3 months , and response to wedged insoles over 3 months will be evaluated .
CONCLUSIONS	This study represents the first step in systematically evaluating the effects of reduced KAMs on knee OA management by using a patient-specific wedged insole prescription procedure rather than providing the same insole to all patients .
CONCLUSIONS	The results of this trial will provide indications as to whether reduced KAMs are an effective strategy for knee OA management , and whether a personalized approach to footwear insole prescription is warranted .
BACKGROUND	NCT02067208 .

###24946646
OBJECTIVE	To compare the effects on anesthesia recovery between assisted-electroacupuncture fast tracking anesthesia and simple fast tracking anesthesia in patients with minim ally invasive percutaneous nephrolithotomy ( mPCNL ) .
METHODS	Eighty cases of mPCNL were selected and randomly divided into a treatment group and a control group .
METHODS	Fentanyl ( 1-2 microg/kg ) , sevoflurane ( 8 % ) and rocuronium ( 0.5 mg/kg ) were applied to perform anesthesia induction in both groups , and endotracheal inhalation of sevoflurane and intravenous pump injection of remifentanil were adopted to main anesthesia status during the operation .
METHODS	20 min before anesthesia induction , bilateral Neiguan ( PC 6 ) , Neimadian , Hegu ( LI 4 ) , Yangxi ( LI 5 ) , Zhongji ( CV 3 ) , Qichong ( ST 30 ) , Zuwuli ( LR 10 ) were selected and punctured in the treatment group , and elecctroacupuncture was given after arrival of qi until 30 min after the wake-up from anesthesia and withdrawal of endotracheal tube .
METHODS	The dosage for anesthesia maintenance , recovery time of awareness , extubation time , incidences of nausea , vomiting and chill and irritation of urethral catheters were observed and recorded .
RESULTS	( 1 ) The dosages of remifentanil and sevoflurane in the treatment group during the operation were obviously less than those in the control group [ remifentanil : ( 5.27 + / -1.23 ) micro g/kg h vs ( 7.35 + / -1.70 ) micro g/kg .
RESULTS	h ; sevoflurane : ( 1.12 + / -0.43 ) vol % vs ( 2.35 + / -0.87 ) vol % , both P < 0.001 ] .
RESULTS	( 2 ) The recovery time of awareness and extubation time in the treatment group were significantly earlier than those in the control group [ recovery time of awareness : ( 5.65 + / - 2.34 ) min vs ( 8.87 + / - 6.84 ) min , P < 0.01 ; extubation time : ( 7.23 + / -4.35 ) min vs ( 10.62 + / -8.16 ) min , P < 0.05 ] .
RESULTS	( 3 ) The incidences of nausea , vomiting and chill in the treatment group were significantly less than those in the control group ( all P < 0.05 ) .
RESULTS	( 4 ) The irritation of urethral catheters on urethra in the treatment group was significantly less than that in the control group ( P < 0.001 ) .
CONCLUSIONS	The assisted-electroacupuncture anesthesia could reduce the dosage of remifentanil and sevoflurane in mPCNL fast tracking anesthesia in urinary surgery , reduce the incidences of nausea , vomiting , chill and irritation of urethral catheters during recovery stage , and prompt recovery of mPCNL patients .

###25259426
BACKGROUND	Photocoagulation reduces the incidence of visual loss in diabetic patients with focal macular edema , but it can induce it for Efficacy of topical ketorolac for improving visual function after photocoagulation in diabetic patients with focal macular edema 6 weeks after treatment and produces visual improvement in some cases .
BACKGROUND	Topical ketorolac may reduce the inflammation caused by photocoagulation and improve visual outcome .
OBJECTIVE	To determine the efficacy of topical ketorolac for improving visual function after photocoagulation in diabetic patients with focal macular edema .
METHODS	An experimental , comparative , prospective , longitudinal study in diabetic patients with focal macular edema was conducted .
METHODS	Eyes were randomized into two groups of topical treatment for 3 weeks after photocoagulation ( A : ketorolac , B : placebo ) .
METHODS	Best corrected visual acuity before and after treatment was compared in each group ( paired t test ) , and the proportion of eyes with visual improvement was compared between groups ( ( 2 ) ) .
METHODS	The evaluation was repeated after stratifying for initial visual acuity ( 0.5 , < 0.5 ) .
RESULTS	There were 105 eyes included .
RESULTS	In group A ( n = 46 ) mean visual acuity changed from 0.50 to 0.58 ( p = 0.003 ) , and from 0.55 to 0.55 in group B ( n = 59 , p = 0.83 ) ; mean percent change was 22.3 % in group A and 3.5 % in group B ( p = 0.03 ) .
RESULTS	Visual improvement was identified in 25 eyes from group A ( 54.3 % ) and 19 from group B ( 32.2 % , p = 0.019 , RR 1.65 ) ; the difference only persisted when initial visual acuity was 0.5 ( 10 [ 40 % ] , group A , 5 [ 14.7 % ] , group B , p = 0.02 , RR 2.72 ) .
CONCLUSIONS	Topical ketorolac was more effective than placebo to improve best corrected visual acuity in diabetic patients with focal macular edema .

###24560477
OBJECTIVE	To describe the effectiveness of buccal misoprostol as an adjunct to laminaria for cervical ripening before later second-trimester abortion by dilation and evacuation ( D&E ) .
METHODS	A randomized , double-blinded , placebo-controlled trial of 196 women undergoing D&E between 21 and 23 weeks of gestation .
METHODS	Subjects had overnight laminaria and 400 mcg buccal misoprostol or placebo 3-4 h before the abortion .
METHODS	We used logarithmic transformation of the primary outcome -- D&E procedure duration -- to achieve a normal distribution .
RESULTS	Mean D&E duration was 1.7 min shorter with misoprostol ( p = .02 ) .
RESULTS	The median duration was 9.7 versus 10.4 min in the misoprostol and placebo groups , respectively ( p = .09 ) .
RESULTS	Cervical dilation was slightly greater with misoprostol ( median 75 mm vs. 73 mm , p = .04 ) ; however , physicians did not find the misoprostol D&E s easier to complete .
RESULTS	Half of subjects reported severe pain after misoprostol vs. 11 % with placebo ( p < .001 ) .
CONCLUSIONS	Adjuvant buccal misoprostol results in slightly shorter D&E s at the cost of more side effects .

###24267796
BACKGROUND	Generalised recalcitrant facial verruca plana responds poorly to current therapeutic options , including cryotherapy , topical drugs and carbon dioxide ( CO2 ) laser .
BACKGROUND	Case reports and uncontrolled studies suggested that topical photodynamic therapy ( PDT ) is effective choice of treatment free from potential complications associated with invasive therapies .
OBJECTIVE	To investigate the efficacy and safety of PDT with different concentrations of photosensitiser in the treatment of verruca plana .
METHODS	The two sides of a subject 's face were separately randomized to receive aminolevulinic acid ( ALA ) of 5 % , 10 % or 20 % concentration .
METHODS	All patients were irradiated with 633-nm red light for 339 J/cm ( 2 ) total dose .
METHODS	Complete response ( CR ) rate was assessed on Week 4 , 8 , and 16 respectively .
RESULTS	The mean overall clearance rate was 74.1 % , 68.8 % , and 64.6 % on Week 4 , 8 , and 12 , respectively , in the 110 treated sides .
RESULTS	The CR rate was lower in the 5 % - ALA group than in the 10 % - ALA group ( 14.3 % vs. 33.3 % , p < 0.05 ) and 20 % - ALA group ( 14.3 % vs. 26.3 % , p < 0.05 ) after 12 weeks .
RESULTS	The mean severity of pain measured by visual analogue scale ( VAS ) scoring was 3.8 ( range : 2 to 10 , depending on the lesion location ) .
RESULTS	The overall recurrence rate was 16.7 % ( 4/24 ) on Week 12 .
RESULTS	Hyperpigmentation was observed in 61 % ( 67/110 ) of all treated sides .
RESULTS	On Week 4 , 8 , and 16 , hyperpigmentation was more developed in the 20 % - ALA group than in the other two groups ( p < 0.05 ) .
CONCLUSIONS	In terms of complete clearance rate , the 5 % ALA-PDT group was significantly inferior to the 10 % and 20 % ALA-PDT groups at each follow-up .
CONCLUSIONS	In contrast , the 20 % ALA group showed a higher incidence rate of transient hyperpigmentation than the other two groups .
CONCLUSIONS	This randomised clinical trial suggests that PDT with ALA of 10 % concentration offers better efficacy and safety than 5 % or 20 % concentration for generalised recalcitrant facial verruca plana .

###24237177
BACKGROUND	Vaccination is crucial to the control of equine influenza ( EI ) .
BACKGROUND	The study was conducted in an effort to lay the groundwork for achieving international harmonisation of regulatory requirements based on scientific evidence of performance of different vaccination regimes .
OBJECTIVE	To evaluate the effectiveness of 3 different primary vaccination regimes : vaccination with the minimal intervals permitted by the racing authorities ; vaccination in accordance with the manufacturer 's instructions and vaccination with the longest intervals permitted by the racing authorities .
METHODS	Randomised , prospective clinical trial .
METHODS	The 55 seronegative unvaccinated horses in this study were subdivided by age and randomly allocated one of the 3 vaccination regimes .
METHODS	All groups were sampled each time a group was vaccinated and 3-5 weeks post vaccination .
METHODS	Horses were vaccinated with a subunit immune stimulating complex-based vaccine ( Equip FT ) .
METHODS	Antibodies against EI were measured by single radial haemolysis .
RESULTS	Lengthening the vaccination intervals increased the immunity gaps between first ( V1 ) and second ( V2 ) doses , and V2 and third dose ( V3 ) but did not inhibit the response to V2 and V3 .
RESULTS	The response to V2 and V3 was similar irrespective of the regime .
RESULTS	Poor responders to V1 were identified in all age groups included in this study but the greatest number of poor responders was among the yearlings .
RESULTS	The 2 - and 3-year-old horses responded better to vaccination than the weanlings or yearlings .
CONCLUSIONS	Longer vaccination intervals permitted by racing authorities increase the periods of susceptibility to EI but they may facilitate strategic vaccination prior to times of increased risk of exposure to virus .
CONCLUSIONS	The study provides the type of evidence-based data necessary to commence meaningful discussion of international harmonisation of EI vaccination requirements .

###24670946
BACKGROUND	The manipulation of the composition of foods consumed as between-meal snacks may aid daily energy restriction .
OBJECTIVE	We compared the effects of the consumption of 2 energy-matched snack bars on appetite , energy intake ( EI ) , and metabolic and endocrine responses .
OBJECTIVE	In addition , we investigated whether the acute effects of the consumption of snacks were maintained under free-living conditions and whether the habitual daily consumption of the snack over 14 d influenced these effects .
METHODS	Ten lean men [ mean SD age : 30.7 9.7 y ; body mass index ( in kg/m ( 2 ) ) : 23.2 2.8 ] consumed a whey protein and polydextrose ( PPX ) snack bar or an isoenergetic control snack bar as a midmorning , between-meal snack for 14 consecutive days in a double-blind , randomized , crossover design .
METHODS	The two 14-d intervention phases were separated by a 14-d washout period .
METHODS	On the first ( day 1 ) and last ( day 15 ) days of each intervention phase , appetite , food intake , and blood metabolite and endocrine responses were assessed under laboratory conditions .
METHODS	Free-living EI was recorded on days 4 , 8 , and 12 of interventions .
RESULTS	Total daily EI was significantly lower when the PPX snack was consumed during experimental days ( 10,149 831 compared with 11,931 896 kJ ; P < 0.01 ) , and daily EI remained lower when the PPX snack was consumed during the free-living part of the intervention ( 7904 610 compared with 9041 928 kJ ; P < 0.05 ) .
RESULTS	The PPX snack was associated with lower glucose and ghrelin and higher glucagon-like peptide 1 and peptide tyrosine-tyrosine responses .
CONCLUSIONS	The manipulation of the composition of foods consumed as snacks is an effective way to limit subsequent EI .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01927926 .

###25920290
OBJECTIVE	To validate the device and investigate the effect of this device on symptoms , quality of life , and pelvic floor muscle strength .
METHODS	The device was designed to measure vaginal pressure changes using air-pressure balloon and abdominal wall muscle activities using surface electromyography .
METHODS	To test the accuracy of the device , for vaginal pressure measurement , a Mercury sphygmomanometer was used as a gold standard , and for abdominal wall muscle activity , a standard biofeedback machine was used as a reference device .
METHODS	A randomized , controlled trial was conducted in sixty-one women with stress urinary incontinence .
METHODS	They were randomly divided into two groups undergoing PFMT with a single 15-minute biofeedback session ( BF + PFMT group ) or without biofeedback ( PFMT group ) .
METHODS	The pelvic floor muscle strength , abdominal wall muscle activity and incontinence-specific quality of life questionnaire ( I-QOL ) , measurements were evaluated at baseline and at 8 - and 16-week after treatment .
RESULTS	The accuracy of vaginal probe pressure perineometry was 98 % compared to a standard sphygmomanometer .
RESULTS	The device could detect abdominal wall muscles activities at 10 milliseconds ( 100 Hz ) , 20 milliseconds ( 50 Hz ) , and 50 milliseconds ( 20 Hz ) .
RESULTS	After 8 and 16 weeks of treatment , there were statistically significant intra-group differences in the maximum vaginal squeeze pressure in both groups .
RESULTS	However , the inter-group differences were not demonstrated .
RESULTS	The proportion of women who performed pelvic floor muscle exercise correctly was significantly higher in the BF + PFMT group ( 72.41 % ) compared to the PFMT group ( 21.88 % ) at week 16 ( p < 0.05 ) .
CONCLUSIONS	The simple pelvic floor muscle strength evaluation device might be helpful in pelvic floor muscle training in a low resource setting .

###24562805
OBJECTIVE	Left ventricular ( LV ) dysfunction during and after hospitalization for ST-segment elevation myocardial infarction ( STEMI ) is associated with increased mortality .
OBJECTIVE	Whether baseline LV dysfunction impacts STEMI outcomes is not well studied .
OBJECTIVE	Furthermore , whether bivalirudin and paclitaxel-eluting stents ( PES ) are beneficial in patients with LV dysfunction is unknown .
OBJECTIVE	We studied the impact of left ventricular ejection fraction ( LVEF ) on outcomes of patients with STEMI in the HORIZONS-AMI trial .
METHODS	LVEF was determined in 2648 ( 73.5 % ) of 3602 enrolled STEMI patients , who were divided into three groups according to LV function : ( 1 ) severely impaired ( LVEF < 40 % ) ; ( 2 ) moderately impaired ( LVEF 40-50 % ) ; and ( 3 ) normal ( LVEF 50 % ) .
RESULTS	Compared to patients with normal LV function , those with severely impaired LVEF had higher 1-year rates of net adverse clinical events ( 27.1 vs. 14.2 % , p < 0.0001 ) , major adverse cardiovascular events ( 20.7 vs. 9.5 % , p < 0.0001 ) , cardiac death ( 10.6 vs. 1.2 % , p < 0.0001 ) , and non-coronary artery bypass graft major bleeding ( 12.5 vs. 6.6 % , p = 0.001 ) , differences which persisted after adjustment for baseline characteristics .
RESULTS	Among patients with LVEF < 40 % , treatment with bivalirudin compared to heparin + GPIIb/IIIa inhibitors resulted in reduced 1-year mortality ( 5.8 vs. 18.3 % , p = 0.007 ) .
RESULTS	Patients with LVEF < 40 % receiving PES rather than bare metal stents had lower rates of 1-year ischaemia-driven target lesion revascularization ( 2.9 vs. 12.6 % , p = 0.02 ) and reinfarction ( 4.5 vs. 14.7 % , p = 0.03 ) .
CONCLUSIONS	Among patients with STEMI undergoing primary percutaneous coronary intervention , adverse events are markedly increased in those with LVEF < 40 % during the index revascularization procedure .
CONCLUSIONS	Nevertheless , these high-risk patients experience substantial clinical benefits from bivalirudin and PES .

###25380107
OBJECTIVE	Increased intracranial pressure ( ICP ) in patients with traumatic brain injury ( TBI ) is associated with a higher mortality rate and poor outcome .
OBJECTIVE	Mannitol and hypertonic saline ( HTS ) have both been used to treat high ICP , but it is unclear which one is more effective .
OBJECTIVE	Here , the authors compare the effect of mannitol versus HTS on lowering the cumulative and daily ICP burdens after severe TBI .
METHODS	The Brain Trauma Foundation TBI-trac New York State database was used for this retrospective study .
METHODS	Patients with severe TBI and intracranial hypertension who received only 1 type of hyperosmotic agent , mannitol or HTS , were included .
METHODS	Patients in the 2 groups were individually matched for Glasgow Coma Scale score ( GCS ) , pupillary reactivity , craniotomy , occurrence of hypotension on Day 1 , and the day of ICP monitor insertion .
METHODS	Patients with missing or erroneous data were excluded .
METHODS	Cumulative and daily ICP burdens were used as primary outcome measures .
METHODS	The cumulative ICP burden was defined as the total number of days with an ICP of > 25 mm Hg , expressed as a percentage of the total number of days of ICP monitoring .
METHODS	The daily ICP burden was calculated as the mean daily duration of an ICP of > 25 mm Hg , expressed as the number of hours per day .
METHODS	The numbers of intensive care unit ( ICU ) days , numbers of days with ICP monitoring , and 2-week mortality rates were also compared between the groups .
METHODS	A 2-sample t-test or chi-square test was used to compare independent samples .
METHODS	The Wilcoxon signed-rank or Cochran-Mantel-Haenszel test was used for comparing matched samples .
RESULTS	A total of 35 patients who received only HTS and 477 who received only mannitol after severe TBI were identified .
RESULTS	Eight patients in the HTS group were excluded because of erroneous or missing data , and 2 other patients did not have matches in the mannitol group .
RESULTS	The remaining 25 patients were matched 1:1 .
RESULTS	Twenty-four patients received 3 % HTS , and 1 received 23.4 % HTS as bolus therapy .
RESULTS	All 25 patients in the mannitol group received 20 % mannitol .
RESULTS	The mean cumulative ICP burden ( 15.52 % [ HTS ] vs 36.5 % [ mannitol ] ; p = 0.003 ) and the mean ( SD ) daily ICP burden ( 0.3 0.6 hours/day [ HTS ] vs 1.3 1.3 hours/day [ mannitol ] ; p = 0.001 ) were significantly lower in the HTS group .
RESULTS	The mean ( SD ) number of ICU days was significantly lower in the HTS group than in the mannitol group ( 8.5 2.1 vs 9.8 0.6 , respectively ; p = 0.004 ) , whereas there was no difference in the numbers of days of ICP monitoring ( p = 0.09 ) .
RESULTS	There were no significant differences between the cumulative median doses of HTS and mannitol ( p = 0.19 ) .
RESULTS	The 2-week mortality rate was lower in the HTS group , but the difference was not statistically significant ( p = 0.56 ) .
CONCLUSIONS	HTS given as bolus therapy was more effective than mannitol in lowering the cumulative and daily ICP burdens after severe TBI .
CONCLUSIONS	Patients in the HTS group had significantly lower number of ICU days .
CONCLUSIONS	The 2-week mortality rates were not statistically different between the 2 groups .

###24395863
OBJECTIVE	This prospective , randomized phase III intergroup trial of the Gynecologic Oncology Group and National Cancer Institute of Canada Clinical Trials Group was designed to test the effectiveness and safety of adding the hypoxic cell sensitizer tirapazamine ( TPZ ) to standard cisplatin ( CIS ) chemoradiotherapy in locally advanced cervix cancer .
METHODS	Patients with locally advanced cervix cancer were randomly assigned to CIS chemoradiotherapy versus CIS/TPZ chemoradiotherapy .
METHODS	Primary end point was progression-free survival ( PFS ) .
METHODS	Secondary end points included overall survival ( OS ) and tolerability .
RESULTS	PFS was evaluable in 387 of 402 patients randomly assigned over 36 months , with enrollment ending in September 2009 .
RESULTS	Because of the lack of TPZ supply , the study did not reach its original target accrual goal .
RESULTS	At median follow-up of 28.3 months , PFS and OS were similar in both arms .
RESULTS	Three-year PFS for the TPZ/CIS/RT and CIS/RT arms were 63.0 % and 64.4 % , respectively ( log-rank P = .7869 ) .
RESULTS	Three-year OS for the TPZ/CIS/RT and CIS/RT arms were 70.5 % and 70.6 % , respectively ( log-rank P = .8333 ) .
RESULTS	A scheduled interim safety analysis led to a reduction in the starting dose for the TPZ/CIS arm , with resulting tolerance in both treatment arms .
CONCLUSIONS	TPZ/CIS chemoradiotherapy was not superior to CIS chemoradiotherapy in either PFS or OS , although definitive commentary was limited by an inadequate number of events ( progression or death ) .
CONCLUSIONS	TPZ/CIS chemoradiotherapy was tolerable at a modified starting dose .

###24289509
OBJECTIVE	We describe the statistical analysis plan ( SAP ) for the Permissive Hyperthermia through Avoidance of Paracetamol in Known or Suspected Infection in the Intensive Care Unit ( HEAT ) trial , a 700-patient , prospective , randomised , Phase 2b , multicentre , double-blind , parallel-groups , placebo-controlled trial of paracetamol administration for the treatment of fever in critically ill patients with known or suspected infection .
METHODS	The data fields described are those outlined in the study protocol published previously .
METHODS	We describe the plan for the presentation and comparison of baseline characteristics , process measures and outcomes .
METHODS	We describe baseline characteristics , and define and categorise trial outcomes according to their assigned importance .
CONCLUSIONS	We developed an SAP for the HEAT trial , and produced a mock Consolidated Standards of Reporting Trials diagram and tables .
CONCLUSIONS	Our prespecified SAP accords with high-quality standards of internal validity and should minimise future analysis bias .

###25932848
OBJECTIVE	To examine the effect of an individually tailored , motivationally matched prenatal exercise intervention on gestational diabetes mellitus ( GDM ) and other measures of glucose intolerance among ethnically diverse prenatal care patients at increased risk for GDM .
METHODS	The Behaviors Affecting Baby and You study randomized eligible women at a mean ( standard deviation ) of 18.2 ( 4.1 ) weeks of gestation to a 12-week individually tailored , motivationally matched exercise intervention or a comparison health and wellness intervention .
METHODS	The goal of the exercise intervention was to achieve the American College of Obstetricians and Gynecologists ' guidelines for physical activity during pregnancy .
METHODS	Diagnosis of GDM , impaired glucose tolerance , abnormal glucose screen , and screening glucose values ( mg/dL ) were abstracted from medical records .
METHODS	A sample size of 352 women ( 176 per group ) was planned to have 80 % power to detect reductions in risk of 35 % or larger .
RESULTS	From July 2007 to December 2012 , a total of 251 ( 86.5 % ) women completed the intervention ; n = 124 and 127 in the exercise and comparison interventions , respectively .
RESULTS	Based on an intention-to-treat analysis , no statistically significant differences between the intervention groups were observed ; the relative odds of GDM in the exercise group was 0.61 ( 95 % confidence interval [ CI ] 0.28-1 .32 ) as compared with the health and wellness comparison group .
RESULTS	Odds ratios for impaired glucose tolerance and abnormal glucose screen were 0.68 ( 95 % CI 0.35-1 .34 ) and 0.86 ( 95 % CI 0.51-1 .47 ) , respectively .
RESULTS	The intervention had no effect on birth outcomes .
CONCLUSIONS	In this randomized trial among ethnically diverse pregnant women at increased risk for GDM , we found that a prenatal exercise intervention implemented in the second trimester did not result in a statistically significant reduction in relative odds for GDM , impaired glucose tolerance , or abnormal glucose screen .
METHODS	I.

###24335629
METHODS	Prospective , multicenter , randomized , and controlled Investigational Device Exemption clinical trial .
OBJECTIVE	To compare the clinical safety and effectiveness of the selectively constrained SECURE-C ( Globus Medical , Audubon , PA ) Cervical Artificial Disc to anterior cervical discectomy and fusion ( ACDF ) .
BACKGROUND	Cervical total disc replacement has been developed as an alternative to ACDF by allowing segmental motion .
BACKGROUND	Current cervical total disc replacement designs incorporate constrained and unconstrained metal-on-metal or metal-on-polymer articulating designs with various means of fixation .
METHODS	A total of 380 patients from 18 investigational sites were prospectively enrolled in the study .
METHODS	Patients were randomized , treated surgically , and evaluated postoperatively at 6 weeks , 3 months , 6 months , 12 months , and 24 months .
METHODS	Clinical outcomes include overall success , visual analogue scale pain ( right arm , left arm , and neck ) , neck disability index , neurological status , Short Form 36 ( SF-36 ) Health Status Survey questionnaires , range of motion , and adverse events .
METHODS	Bayesian statistical methods were used to analyze the outcomes .
RESULTS	Overall success results demonstrated statistical superiority of the randomized SECURE-C group compared with the randomized ACDF group at 24 months , with a posterior probability of 100 % using the protocol-specified criteria and 98.1 % using Food and Drug Administration-defined criteria .
RESULTS	At 24 months postoperatively , SECURE-C demonstrated clinically significant improvement in pain and function in terms of neck disability index , visual analogue scale , and 36-Item Short Form Health Survey .
RESULTS	At 24 months , the percentage of patients experiencing secondary surgical interventions at the index level was statistically lower for the SECURE-C group ( 2.5 % ) than the ACDF group ( 9.7 % ) .
RESULTS	At 24 months , 84.6 % of as-treated SECURE-C patients were range-of-motion successes .
RESULTS	Satisfaction was high among SECURE-C patients .
CONCLUSIONS	The selectively constrained SECURE-C Cervical Artificial Disc is as safe and effective as the standard of care , an anterior cervical discectomy and fusion .
CONCLUSIONS	SECURE-C is statistically superior in terms of overall success , index-level subsequent surgical procedures , and patient satisfaction , making it an attractive surgical option for patients with symptomatic cervical disc disease .
METHODS	1 .

###25773378
BACKGROUND	Alirocumab , a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 ( PCSK9 ) , has been shown to reduce low-density lipoprotein ( LDL ) cholesterol levels in patients who are receiving statin therapy .
BACKGROUND	Larger and longer-term studies are needed to establish safety and efficacy .
METHODS	We conducted a randomized trial involving 2341 patients at high risk for cardiovascular events who had LDL cholesterol levels of 70 mg per deciliter ( 1.8 mmol per liter ) or more and were receiving treatment with statins at the maximum tolerated dose ( the highest dose associated with an acceptable side-effect profile ) , with or without other lipid-lowering therapy .
METHODS	Patients were randomly assigned in a 2:1 ratio to receive alirocumab ( 150 mg ) or placebo as a 1-ml subcutaneous injection every 2 weeks for 78 weeks .
METHODS	The primary efficacy end point was the percentage change in calculated LDL cholesterol level from baseline to week 24 .
RESULTS	At week 24 , the difference between the alirocumab and placebo groups in the mean percentage change from baseline in calculated LDL cholesterol level was -62 percentage points ( P < 0.001 ) ; the treatment effect remained consistent over a period of 78 weeks .
RESULTS	The alirocumab group , as compared with the placebo group , had higher rates of injection-site reactions ( 5.9 % vs. 4.2 % ) , myalgia ( 5.4 % vs. 2.9 % ) , neurocognitive events ( 1.2 % vs. 0.5 % ) , and ophthalmologic events ( 2.9 % vs. 1.9 % ) .
RESULTS	In a post hoc analysis , the rate of major adverse cardiovascular events ( death from coronary heart disease , nonfatal myocardial infarction , fatal or nonfatal ischemic stroke , or unstable angina requiring hospitalization ) was lower with alirocumab than with placebo ( 1.7 % vs. 3.3 % ; hazard ratio , 0.52 ; 95 % confidence interval , 0.31 to 0.90 ; nominal P = 0.02 ) .
CONCLUSIONS	Over a period of 78 weeks , alirocumab , when added to statin therapy at the maximum tolerated dose , significantly reduced LDL cholesterol levels .
CONCLUSIONS	In a post hoc analysis , there was evidence of a reduction in the rate of cardiovascular events with alirocumab .
CONCLUSIONS	( Funded by Sanofi and Regeneron Pharmaceuticals ; ODYSSEY LONG TERM ClinicalTrials.gov number , NCT01507831 . )

###24399119
OBJECTIVE	The relationship between lower urinary tract symptoms ( LUTS ) and erectile dysfunction ( ED ) has recently received increased attention .
OBJECTIVE	The aim of this study was to evaluate the efficacy of the Alfa-5 association of Serenoa repens , Pinus massoniana Bark Extract ( PMBE ) and Crocus sativus ( IDIProst Gold ) in improvement of patient 's quality of life , when compared with Serenoa repens alone .
METHODS	All patients with clinical and instrumental diagnosis of LUTS due to Benign Prostatic Hyperplasia ( BPH ) and ED , attending 5 Italians Urological Institutions from May to December 2012 were enrolled in this prospective , multicentre , phase 3 study .
METHODS	Participants were assigned to receive oral capsules of IDIProst Gold ( one capsule q24 h ) or Serenoa repens 320 mg ( one capsule q24h ) for 3 months .
METHODS	Clinical and instrumental analyses were carried out at the enrollment and at the end of therapy .
METHODS	IPSS , IIEF-5 and SF-36 questionnaires have been used .
METHODS	The main outcome measure was the improvement of quality of life at the end of the whole study period .
RESULTS	129 ( mean age 45-71 4.36 ) men were randomly allocated to IDIProst Gold ( n = 83 ) or Serenoa repens ( n = 46 ) .
RESULTS	The baseline questionnaire mean scores were 17.1 6.4 , 14.9 3.7 , 96.3 1.2 for IPSS , IIEF-5 and SF-36 , respectively .
RESULTS	At the follow-up examination , statistically significant differences have been reported in terms of IPSS ( 11.9 vs 13.8 ; p < 0.001 ) , IIEF-5 and SF-36 mean scores ( 19.3 vs 16.1 ; 99.7 vs 96.3 ; p < 0.003 ; p < 0.001 ) .
RESULTS	Moreover , statistically significant differences were then reported between the two visits , in terms of IPSS , IIEF-5 and SF-36 scores ( p < 0.003 ; p < 0.001 ; p < 0.001 ) , only in the IDIProst Gold group .
CONCLUSIONS	In conclusions , we found that IDIProst Gold significantly improve the quality of life of patients affected by LUTS due to BPH and ED , specifically in terms of sexual function , highlighting that a better sexual quality of life is correlated with an higher overall quality of life regardless of the urinary function .

###24322377
OBJECTIVE	The aim of this study was to evaluate efficacy and safety of gemcitabine plus S-1 ( GS ) combination chemotherapy in patients with unresectable pancreatic cancer .
METHODS	Patients were randomly assigned to receive GS ( oral S-1 60mg/m ( 2 ) daily on days 1-15 every 3weeks and gemcitabine 1,000 mg/m ( 2 ) on days 8 and 15 ) or gemcitabine ( 1,000 mg/m ( 2 ) on days 1 , 8 , and 15 every 4weeks ) .
METHODS	The primary endpoint was progression-free survival ( PFS ) .
RESULTS	One hundred and one patients were randomly assigned .
RESULTS	PFS was significantly longer in the GS arm with an estimated hazard ratio ( HR ) of 0.65 ( 95 % CI 0.43-0 .98 ; P = 0.039 ; median 5.3 vs 3.8 months ) .
RESULTS	Objective response rate ( ORR ) was also better in the GS arm ( 21.6 vs 6 % , P = 0.048 ) .
RESULTS	Median survival was 8.6 months for GS and 8.6 months for GEM ( HR 0.93 ; 95 % CI 0.61-1 .41 ; P = 0.714 ) .
RESULTS	Grade 3-4 neutropenia ( 44 vs 19.6 % , P = 0.011 ) and thrombocytopenia ( 26 vs 8.7 % , P = 0.051 ) were more frequent in the GS arm .
CONCLUSIONS	GS therapy improved PFS and ORR with acceptable toxicity profile in patients with unresectable pancreatic cancer .

###25827032
OBJECTIVE	Few studies targeting obesity in serious mental illness have reported clinically significant risk reduction , and none have been replicated in community settings or demonstrated sustained outcomes after intervention withdrawal .
OBJECTIVE	The authors sought to replicate positive health outcomes demonstrated in a previous randomized effectiveness study of the In SHAPE program across urban community mental health organizations serving an ethnically diverse population .
METHODS	Persons with serious mental illness and a body mass index ( BMI ) > 25 receiving services in three community mental health organizations were recruited and randomly assigned either to the 12-month In SHAPE program , which included membership in a public fitness club and weekly meetings with a health promotion coach , or to fitness club membership alone .
METHODS	The primary outcome measures were weight and cardiorespiratory fitness ( as measured with the 6-minute walk test ) , assessed at baseline and at 3 , 6 , 9 , 12 , and 18 months .
RESULTS	Participants ( N = 210 ) were ethnically diverse ( 46 % were nonwhite ) , with a mean baseline BMI of 36.8 ( SD = 8.2 ) .
RESULTS	At 12 months , the In SHAPE group ( N = 104 ) had greater reduction in weight and improved fitness compared with the fitness club membership only group ( N = 106 ) .
RESULTS	Primary outcomes were maintained at 18 months .
RESULTS	Approximately half of the In SHAPE group ( 51 % at 12 months and 46 % at 18 months ) achieved clinically significant cardiovascular risk reduction ( a weight loss 5 % or an increase of > 50 meters on the 6-minute walk test ) .
CONCLUSIONS	This is the first replication study confirming the effectiveness of a health coaching intervention in achieving and sustaining clinically significant reductions in cardiovascular risk for overweight and obese persons with serious mental illness .

###25143491
BACKGROUND	Allograft safety is contingent on effective sterilization .
BACKGROUND	However , current sterilization methods have been associated with decreased biomechanical strength and higher failure rates of soft-tissue allografts .
BACKGROUND	In this study , electron beam ( e-beam ) sterilization was explored as an alternative sterilization method to preserve biomechanical integrity .
BACKGROUND	We hypothesized that e-beam sterilization would not significantly alter the biomechanical properties of tendon allograft compared with aseptic , nonsterilized controls and gamma-irradiated grafts .
METHODS	Separate sets of forty fresh-frozen tibialis tendon allografts ( four from each of ten donors ) and forty bisected bone-patellar tendon-bone ( BTB ) allografts ( four from each of ten donors ) were randomly assigned to four study groups .
METHODS	One group received a 17.1 to 21.0-kGy gamma radiation dose ; two other groups were sterilized with an e-beam at either a high ( 17.1 to 21.0-kGy ) or low ( 9.2 to 12.2-kGy ) dose .
METHODS	A fourth group served as nonsterilized controls .
METHODS	Each graft was cyclically loaded to 200 N of tension for 2000 cycles at a frequency of 2 Hz , allowed to relax for five minutes , and then tested in tension until failure at a 100 % / sec strain rate .
METHODS	One-way analysis of variance testing was used to identify significant differences .
RESULTS	Tibialis tendons sterilized with both e-beam treatments and with gamma irradiation exhibited values for cyclic tendon elongation , maximum load , maximum displacement , stiffness , maximum stress , maximum strain , and elastic modulus that were not significantly different from those of nonsterilized controls .
RESULTS	BTB allografts sterilized with the high e-beam dose and with gamma irradiation were not significantly different in cyclic tendon elongation , maximum load , maximum displacement , stiffness , maximum stress , maximum strain , and elastic modulus from nonsterilized controls .
RESULTS	BTB allografts sterilized with the e-beam at the lower dose were significantly less stiff than nonsterilized controls ( p = 0.014 ) but did not differ from controls in any other properties .
RESULTS	The difference in stiffness likely resulted from variations in tendon size rather than the treatments , as the elastic moduli of the groups were similar .
CONCLUSIONS	The biomechanical properties of tibialis and BTB allografts sterilized with use of an e-beam at a dose range of 17.1 to 21.0 kGy were not different from those of aseptic , nonsterilized controls or gamma-irradiated allografts .
CONCLUSIONS	E-beam sterilization can be a viable method to produce safe and biomechanically uncompromised soft-tissue allografts .

###25410507
BACKGROUND	Angular stable locking of intramedullary nails has been shown to enhance fixation stability of tibial fractures in biomechanical and animal studies .
BACKGROUND	The aim of our study was to assess whether use of the angular stable locking system or conventional locking resulted in earlier full weight-bearing with minimum pain for patients with a distal tibial fracture treated with an intramedullary nail .
METHODS	A prospective multicenter , randomized , patient-blinded trial was conducted with adults who had a distal tibial fracture .
METHODS	Patients ' fractures were managed with an intramedullary nail locked with either an angular stable locking system or conventional locking screws .
METHODS	Outcomes were evaluated at six weeks , twelve weeks , six months , and one year after surgery .
METHODS	Time to full weight-bearing with minimum pain was calculated with use of daily entries from patient diaries .
METHODS	Secondary outcomes included pain at the fracture site under load , quality of life , gait analysis , mobility , radiographic findings , and adverse events .
RESULTS	One hundred and forty-two patients were randomly allocated to two treatment groups : seventy-five to the group receiving intramedullary nailing with the angular stable locking system and sixty-seven to the group receiving conventional intramedullary nailing .
RESULTS	No clinically important differences were found for either the primary or secondary outcome parameters between the groups during the entire follow-up period .
CONCLUSIONS	Use of an angular stable locking system with intramedullary nailing did not improve the outcome compared with conventional locking screws in the treatment of distal tibial fractures .

###24683578
OBJECTIVE	Ridge preservation protocols reduce crestal remodeling after tooth extraction .
OBJECTIVE	There is insufficient evidence on bone grafting in combination with platelet-rich plasma ( PRP ) or recombinant human platelet-derived growth factor ( rhPDGF-BB ) .
OBJECTIVE	The aim of this study is to evaluate healing of grafted and nongrafted sockets and the effect of PRP and rhPDGF-BB on early remodeling .
METHODS	Forty-one patients whose treatment plan included extraction of anterior or premolar teeth were randomized into four groups .
METHODS	Group 1 : collagen plug ( control ) .
METHODS	Group 2 : mineralized freeze-dried bone allograft ( FDBA ) / - tricalcium phosphate ( - TCP ) / collagen plug .
METHODS	Group 3 : FDBA / - TCP/PRP/collagen plug .
METHODS	Group 4 : FDBA / - TCP/rhPDGF-BB/collagen plug .
METHODS	At 8 weeks , a core was harvested from the center of 41 sockets .
METHODS	Histomorphometric analysis took place .
METHODS	Differences were analyzed using one-way analysis of variance ( ANOVA ) or chi-square tests for continuous and categorical data .
METHODS	Pairwise comparisons were tested using least squares means .
METHODS	Spearman correlation coefficients were used to evaluate the relationship of bone growth with potential confounders .
METHODS	A P value < .05 was considered statistically significant .
RESULTS	ANOVA did not indicate statistical significance in age , gender , smoking , ethnicity , or race distribution .
RESULTS	Significant differences in tissue distribution were identified between groups and between different thirds of harvested core .
RESULTS	More new bone and amorphous organic matrix was noted in the control group .
RESULTS	In sites where bone graft was combined with growth factors , the amount of residual particles was less than in sites where bone graft was used alone .
CONCLUSIONS	Inclusion of bone replacement graft suppressed new bone formation during early healing .
CONCLUSIONS	Inclusion of PRP and rhPDGF-BB produced less residual bone graft material , indicating more rapid turnover of bone graft .
CONCLUSIONS	All treatment modalities achieved a significant amount of new vital bone at 8 weeks postextraction .

###24901821
OBJECTIVE	To investigate in this phase 2a study ( ZENITH ) the safety , tolerability , and antiviral activity of VX-222 , a selective , non-nucleoside inhibitor of hepatitis C virus ( HCV ) NS5B polymerase , combined with various telaprevir-based regimens for treatment of genotype 1 HCV .
METHODS	In total , 152 treatment-naive patients received VX-222 + telaprevir ( ` DUAL ' regimen ; n = 47 ) , with ribavirin ( ` TRIPLE ' regimen ; n = 46 ) , or with peginterferon + ribavirin ( ` QUAD ' regimen ; n = 59 ) for 12 weeks .
METHODS	Patients with detectable HCV RNA at weeks 2 and/or 8 received peginterferon + ribavirin for 24 ( DUAL and TRIPLE ) or 12 ( QUAD ) additional weeks .
RESULTS	VX-222 ( 100 or 400 mg twice daily ) was well tolerated , with an increased rate of gastrointestinal adverse events observed with the higher dose .
RESULTS	Across VX-222 400-mg twice-daily regimens , the QUAD was associated with the highest frequency of grade 3/4 adverse events .
RESULTS	The DUAL was discontinued because of high viral breakthrough before week 12 .
RESULTS	Sustained virologic response ( SVR ) 24 weeks after end of treatment ( SVR24 ) , including patients treated with 12 or 24 additional weeks of peginterferon + ribavirin , was 67 % for TRIPLE ( VX-222 400 mg twice daily ) and 79 and 90 % for QUAD ( VX-222 100 and 400 mg twice daily , respectively ) .
CONCLUSIONS	These results provide valuable information regarding the safety , tolerability , and efficacy of telaprevir combined with a non-nucleoside polymerase inhibitor , as dual therapy or with ribavirin without or with peginterferon .
CONCLUSIONS	Telaprevir and VX-222 , alone or with ribavirin without or with peginterferon , were generally well tolerated , with improved tolerability without peginterferon .
CONCLUSIONS	SVR24 rates achieved with TRIPLE and QUAD regimens containing telaprevir and VX-222 were comparable to those observed with telaprevir-based therapy .

###24692535
BACKGROUND	Remote ischemic preconditioning may result in reduction in infarct size during percutaneous coronary intervention ( PCI ) .
BACKGROUND	It is unclear whether remote ischemic postconditioning ( RIPost ) will reduce the incidence of myocardial injury after PCI , and whether ischemic conditioning of a larger remote organ ( thigh versus arm ) would provide further myocardial protection .
RESULTS	We randomized 360 patients presenting with stable or unstable angina ( 28 % of patients ) and negative Troponin T at baseline to 3 groups : 2 groups received RIPost ( induced by ischemia to upper or lower limb ) , and a third was the control group .
RESULTS	RIPost was applied during PCI immediately after stent deployment , by three 5-minute cycles of blood pressure cuff inflation to > 200 mmHg in the arm or thigh ( 20 mmHg in the control ) with 5-minute breaks between each cycle .
RESULTS	The primary end-point was the proportion of patients with Troponin T levels > 3ULN postprocedure ( at 6 or 18-24 hours ) , where ULN stands for upper limit of normal .
RESULTS	A total of 120 patients were randomized to each group .
RESULTS	There were no differences in baseline characteristics between the 3 groups .
RESULTS	The primary outcome occurred in 30 % , 35 % , and 35 % of the arm , thigh , and control groups , respectively ( P = 0.64 ) .
RESULTS	There were no differences in creatine kinase or high sensitivity C-reactive protein levels after PCI or in the incidence of acute kidney injury between the groups .
CONCLUSIONS	RIPost during PCI did not reduce the incidence of periprocedural myocardial injury .
CONCLUSIONS	Similar effect was obtained when remote ischemia was induced to the upper or lower limb .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00970827 .

###24666194
BACKGROUND	The term angiokeratoma refers to a group of unrelated diseases with similar histopathologic features .
BACKGROUND	Four clinical variants of angiokeratoma have been described .
BACKGROUND	However , it is not known whether some variants of angiokeratoma are of lymphatic origin , and an immunohistochemical study of lymphatic markers has not been previously performed .
METHODS	We performed an immunohistochemical study of angiokeratomas using lymphatic markers .
METHODS	Fifteen cases of angiokeratoma corporis diffusum , 10 cases of Fordyce angiokeratoma , 10 cases of Mibelli angiokeratoma and 10 cases of solitary angiokeratoma were examined by immunohistochemical analysis using CD31 , D2-40 , Prox1 and Wilms ' tumor 1 ( WT-1 ) .
RESULTS	The vessels of angiokeratoma corporis diffusum , Fordyce angiokeratoma and solitary angiokeratoma were usually focally positive for D2-40 and positive for Prox1 , whereas the vessels of Mibelli angiokeratoma were negative for D2-40 and positive for Prox1 .
CONCLUSIONS	The results suggest lymphatic derivation of angiokeratoma corporis diffusum , Fordyce angiokeratoma and solitary angiokeratoma .
CONCLUSIONS	However , the derivation of Mibelli angiokeratoma could not be determined based on the present immunohistochemical results .

###24359456
BACKGROUND	The purpose of this research was to replicate a successful intervention to increase physical activity in a different region of the country , and explore genetic and physiological moderators of intervention efficacy drawn from a transdisciplinary theoretical framework .
METHODS	A randomized controlled trial comparing a print-based physical activity intervention ( COSTRIDE ) to a print-based health and wellness contact control ( HW ) intervention was conducted .
METHODS	Sedentary participants ( n = 219 ) completed assessments at baseline and follow-up assessments at 3 , 6 , 9 , and 12months following the initiation of the intervention .
RESULTS	Participants in both conditions significantly increased exercise behavior in the first six months , and then leveled off or decreased physical activity in the second six months of the study .
RESULTS	Those in the COSTRIDE intervention increased significantly more than those in the HW intervention , and were better able to maintain their exercise behavior .
RESULTS	Genetic factors ( BDNF , rs6265 ; FTO , rs8044769 ) , but not selected physiological ( body temperature , blood lactate , systolic blood pressure , plasma norepinephrine , and heart rate ) or subjective ( perceived pain , affect ) responses to physical activity , moderated response to the intervention .
CONCLUSIONS	There are underlying genetic factors that influence response to behavioral intervention , and a better understanding of these factors has the potential to influence the development , targeting and tailoring of behavioral interventions to increase physical activity .
BACKGROUND	Clinicaltrials.gov registration : NCT01091857 .

###24439741
BACKGROUND	Subcuticular closure provides a superior cosmetic result in clean wounds .
BACKGROUND	The aim of this work was to investigate the safety in terms of postoperative infection and cosmetic effectiveness of subcuticular wound closure after elective colon cancer surgery in clean-contaminated wounds .
METHODS	Patients who underwent elective resection of colon cancer were randomized to interrupted subcuticular and interrupted transdermal suture groups .
METHODS	The large bowel was prepared by mechanical washout with polyethylene glycol .
METHODS	All patients received metronidazole and kanamycin orally and flomoxef sodium once parenterally for antimicrobial prophylaxis .
METHODS	The primary end point was the incidence of incisional surgical-site infections within 30 days after operation .
METHODS	We assessed noninferiority of subcuticular suture within a margin of 10 % .
METHODS	Analysis was by intent-to-treat .
METHODS	Secondary objectives include comparison of wound closure time , comfort , and cosmesis of the scar and satisfaction of patients .
METHODS	This study was registered with UMIN-CTR , UMIN000003005 .
RESULTS	A total of 293 patients were randomized to the two groups .
RESULTS	Incisional surgical-site infection rates were 11.0 % ( 90 % confidence interval 7.0-16 .3 % ) for both groups .
RESULTS	The relative risk of subcuticular suture was 1.00 ( 0.58-1 .73 , one-tail P = .57 ) .
RESULTS	Interrupted subcuticular suture was noninferior to interrupted transdermal suture ( P = .0088 ) .
RESULTS	Throughout 6 months after operation , patients expressed a significant preference for the subcuticular suture technique , noting rapid relief from pain , decreased vascularity , and smaller width , although the procedure took twice as long .
CONCLUSIONS	Subcuticular suture did not increase the incidence of wound complications in elective colon cancer operation .
CONCLUSIONS	Patients preferred a technique of interrupted subcuticular closure , citing better cosmetic results , and less pain .

###25639957
OBJECTIVE	Life-threatening ear , nose , and throat ( ENT ) emergencies are uncommon but require immediate skilled management .
OBJECTIVE	We investigated if traditional lecture-based teaching can be improved by a simulation and lecture hybrid approach .
METHODS	A single-blinded , prospective , randomized controlled trial .
METHODS	Two groups of interns with no previous ENT experience were randomized to one of two training groups : a simulation/lecture hybrid group or a lecture-only control group .
METHODS	Both groups received 90 minutes of training covering the assessment of critically ill patients and four ENT emergency topics .
METHODS	Both groups received the same initial lecture slides .
METHODS	The control group received additional slides , and the simulation group received simulated emergency scenario training using basic mannequins .
METHODS	Following the training , candidates were asked to provide feedback on their perception of training , and they were formally assessed with a standardized one-to-one viva .
RESULTS	Thirty-eight interns were recruited : 18 in the control group and 20 in the simulation group .
RESULTS	The candidates in the simulation group performed significantly better in all viva situations ( P < .05 ) and had better perception of learning ( P < .05 ) .
RESULTS	Additionally , the simulation group was more likely to recommend the training to a colleague ( P < .05 ) .
CONCLUSIONS	We have demonstrated that replacing traditional lecture-based training with a mixture of lectures and emergency scenario simulation is more effective at preparing junior doctors for ENT emergencies , and better met their learning needs .
CONCLUSIONS	Implementing this kind of teaching is feasible with a minimum of additional resources or time .
METHODS	1b

###24457404
OBJECTIVE	Polycystic ovary syndrome ( PCOS ) is characterized by obesity and insulin resistance ( IR ) , which result in elevated plasminogen activator inhibitor-1 ( PAI-1 ) levels .
OBJECTIVE	We aimed to assess the changes in PAI-1 levels in PCOS during treatment with metformin and during weight loss .
METHODS	Twenty-three normal weight women with PCOS were given metformin 850 mg bid for 6 months .
METHODS	Fifty overweight/obese women with PCOS were prescribed an energy-restricted diet , were instructed to exercise and were randomized to orlistat 120 mg tid or sibutramine 10 mg qd for 6 months .
RESULTS	In normal weight women , treatment with metformin reduced the body mass index ( BMI ) and circulating androgens , improved markers of IR and lowered PAI-1 levels .
RESULTS	In overweight/obese women , sibutramine and orlistat yielded comparable reductions in BMI and markers of IR .
RESULTS	In contrast , the effects on the free androgen index ( FAI ) differed ( p = 0.027 ) : sibutramine reduced the FAI ( p = 0.005 ) , whereas orlistat had no effect .
RESULTS	The effects of sibutramine and orlistat on PAI-1 levels also differed ( p = 0.042 ) : sibutramine reduced PAI-1 levels ( p < 0.001 ) , whereas orlistat had no effect .
CONCLUSIONS	Metformin and sibutramine , but not orlistat , reduce PAI-1 levels in PCOS .
CONCLUSIONS	The reduction in circulating androgens during metformin and sibutramine treatment might be implicated in this decline .

###25700288
OBJECTIVE	There are limited data on the extent of blood-brain barrier ( BBB ) compromise in acute intracerebral hemorrhage patients .
OBJECTIVE	We tested the hypotheses that BBB compromise measured with permeability-surface area product ( PS ) is increased in the perihematoma region and predicts perihematoma edema growth in acute intracerebral hemorrhage patients .
METHODS	Patients were randomized within 24 hours of symptom onset to a systolic blood pressure ( SBP ) treatment of < 150 ( n = 26 ) or < 180 mm Hg ( n = 27 ) .
METHODS	Permeability maps were generated using computed tomographic perfusion source data acquired 2 hours after randomization , and mean PS was measured in the hematoma , perihematoma , and hemispheric regions .
METHODS	Hematoma and edema volumes were measured on noncontrast computed tomographic scans obtained at baseline , 2 hours and 24 hours after randomization .
RESULTS	Patients were randomized at a median ( interquartile range ) time of 9.3 hours ( 14.1 ) from symptom onset .
RESULTS	Treatment groups were balanced with respect to baseline SBP and hematoma volume .
RESULTS	Perihematoma PS ( 5.12.4 mL/100 mL per minute ) was higher than PS in contralateral regions ( 3.61.7 mL/100 mL per minute ; P < 0.001 ) .
RESULTS	Relative edema growth ( 0-24 hours ) was not predicted by perihematoma PS ( = -0.192 [ -0.06 to 0.01 ] ) or SBP change ( = -0.092 [ -0.002 to 0.001 ] ) .
RESULTS	SBP was lower in the < 150 target group ( 139.222.1 mm Hg ) than in the < 180 group ( 159.712.3 mm Hg ; P < 0.0001 ) .
RESULTS	Perihematoma PS was not different between groups ( 4.92.4 mL/100 mL per minute for the < 150 group , 5.32.4 mL/100 mL per minute for the < 180 group ; P = 0.51 ) .
CONCLUSIONS	BBB permeability is focally increased in the hematoma and perihematoma regions of acute intracerebral hemorrhage patients .
CONCLUSIONS	BBB compromise does not predict acute perihematoma edema volume or edema growth .
CONCLUSIONS	SBP reduction does not affect BBB permeability .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00963976 .

###24517583
OBJECTIVE	To implement and evaluate an evidence-informed multicomponent strategy to reduce physical restraint use in older adults admitted to acute care medical units .
METHODS	Stepped-wedge trial .
METHODS	Four acute care medical units in Calgary , Alberta , over a 4-month time period .
METHODS	Data were collected from individuals aged 65 and older present on the study units during monthly restraint audits .
METHODS	Development of opinion leaders among the nursing leadership , education and training of physicians and unit nurses , and implementation of least restraint rounds .
METHODS	The primary outcome was rate of restraint use as determined from walk-around audits .
METHODS	Secondary outcomes included number of physician orders for physical restraints on the electronic medical record and fall reports .
RESULTS	Thirteen percent to 27 % of individuals were being restrained on the medical units before the intervention , with the vast majority of restraints being bed rails .
RESULTS	This decreased to 7 % to 14 % after the intervention .
RESULTS	The intervention resulted in a statistically significant reduction in restraint use measured in the early mornings ( P = .01 ) , and this trend continued after adjusting for unit and month ( P = .06 ) .
RESULTS	Similarly , the rate of restraint use trended down at all other measured time periods but was not statistically significant .
RESULTS	A limited number of individuals had an order for physical restraint within their electronic medical record ( 3 % before , 2 % after the intervention ) .
RESULTS	The median number of monthly fall reports did not change ( three before , three after ; P = .60 ) .
CONCLUSIONS	A multicomponent team-focused quality improvement intervention has the potential to decrease the use of physical restraints in older hospitalized adults .

###25182501
OBJECTIVE	To evaluate the effect of neck coordination exercise on sensorimotor function in women with neck pain compared with best-available treatment and sham treatment .
METHODS	Observer-blinded randomized controlled trial with short-term and 6-month follow-ups .
METHODS	Women with chronic non-specific neck pain were randomized to 3 groups : neck coordination exercise with a novel training device ; strength training for the neck and shoulders ; or massage .
METHODS	Each group had 36 participants .
METHODS	The intervention period was 11 weeks with 22 individually supervised sessions .
METHODS	Primary outcomes were postural sway measures and precision of goal-directed arm movements .
METHODS	Secondary outcomes were range of motion for the neck , peak speed of axial rotation , and neck pain .
METHODS	A repeated measures multivariate analysis of variance ( MANOVA ) was conducted separately on the primary outcomes for the short-term and 6-month evaluations and on the sensorimotor secondary outcomes for the 6-month effect .
METHODS	The 6-month effect on pain was analysed with a repeated measures analysis of variance ( ANOVA ) .
RESULTS	No significant treatment effects in favour of neck coordination exercise were found for short-term or 6-month evaluations .
CONCLUSIONS	Neck coordination exercise is no better than strength training and massage in improving sensorimotor function .
CONCLUSIONS	Further research should investigate the use of cut-offs for sensorimotor dysfunctions prior to proprioceptive or coordinative training .

###25048500
OBJECTIVE	Opioids improve pain from knee and hip osteoarthritis ( OA ) and decrease the functional impairment of patients .
OBJECTIVE	However , there is a possibility that opioids induce analgesia and suppress the physiological pain of OA in patients , thereby inducing the progression of OA changes in these patients .
OBJECTIVE	The purpose of the current study was to investigate the possibility of progressive changes in OA among patients using opioids .
METHODS	Two hundred knee or hip OA patients were evaluated in the current prospective , randomized , active-controlled study .
METHODS	Patients were randomized 1:1:1 into three parallel treatment groups : loxoprofen , tramadol/acetaminophen , and transdermal fentanyl groups .
METHODS	Medication was administered for 12 weeks .
METHODS	Pain scores and progressive OA changes on X-ray films were evaluated .
RESULTS	Overall , pain relief was obtained by all three groups .
RESULTS	Most patients did not show progressive OA changes ; however , 3 patients in the transdermal fentanyl group showed progressive OA changes during the 12 weeks of treatment .
RESULTS	These 3 patients used significantly higher doses than others in the transdermal fentanyl group .
RESULTS	Additionally , the average pain score for these 3 patients was significantly lower than the average pain score for the other patients in the transdermal fentanyl group .
CONCLUSIONS	Fentanyl may induce progressive changes in knee or hip OA during a relatively short period , compared with oral Non-Steroidal Anti-Inflammatory Drugs or tramadol .

###25687568
OBJECTIVE	Probiotics are live microorganisms that may confer health benefits on the host .
OBJECTIVE	Recent trials of probiotic use among healthy pregnant women demonstrate potential for improved glycemic control .
OBJECTIVE	The aim of this study was to investigate the effects of a probiotic capsule intervention on maternal metabolic parameters and pregnancy outcome among women with gestational diabetes .
METHODS	This double-blind placebo-controlled randomized trialrecruited pregnant women with a new diagnosis of gestational diabetes or impaired glucose tolerance following a 3-hour 100-g glucose tolerance test .
METHODS	Women were randomized to a daily probiotic ( Lactobacillus salivarius UCC118 ) or placebo capsule from diagnosis until delivery .
METHODS	Fasting blood samples were collected at baseline and 4-6 weeks after capsule commencement for analysis of glucose , insulin , c-peptide , and lipids .
METHODS	The primary outcome was difference in fasting glucose postintervention , first analyzed on an intention-to-treat basis and followed by per-protocol analysis that excluded women commenced on pharmacological therapy ( insulin or metformin ) .
METHODS	Secondary outcomes were changes in insulin , c-peptide , homeostasis model assessment and lipids , requirement for pharmacological therapy , and neonatal anthropometry .
RESULTS	Of 149 women recruited and randomized , there were nodifferences between the probiotic and placebo groups in postintervention fasting glucose ( 4.65 0.49 vs 4.65 0.53 mmol/L ; P = 373 ) , requirement for pharmacological therapy ( 17 % vs 14 % ; P = .643 ) , or birthweight ( 3.57 0.64 vs 3.60 0.57 kg ; P = .845 ) .
RESULTS	Among 100 women managed with diet and exercise alone , fastingplasma glucose decreased significantly within both the probiotic ( 4.76 0.45 to 4.57 0.42 mmol/L ; P < .001 ) and placebo ( 4.85 0.58 to 4.58 0.45 mmol/L ; P < .001 ) groups , but the levels between groups did not differ ( P = .316 ) .
RESULTS	The late gestation-related rise in totaland low-density lipoprotein ( LDL ) cholesterol was attenuated in theprobiotic vs the placebo group ( +0.27 0.48 vs +0.50 0.52 mmol/L total cholesterol , P = .031 ; +0.08 0.51 vs +0.31 0.45 mmol/L LDL cholesterol , P = .011 ) .
RESULTS	No differences were notedbetween groups in other metabolic parameters or pregnancy outcome .
CONCLUSIONS	A probiotic capsule intervention among women with abnormal glucose tolerance had no impact on glycemic control .
CONCLUSIONS	The observed attenuation of the normal pregnancy-induced rise in total and LDL cholesterol following probiotic treatment requires further investigation , particularly in this obstetric group at risk of future metabolic syndrome .

###25098661
BACKGROUND	Various designs of braces including hinged and nonhinged models are used to provide external support of the ankle .
BACKGROUND	Hinged ankle braces supposedly allow almost free dorsiflexion and plantar flexion of the foot in the sagittal plane .
BACKGROUND	It is unclear , however , whether this additional degree of freedom affects the stabilizing effect of the brace in the other planes of motion .
OBJECTIVE	To investigate the dynamic and passive stabilizing effects of 3 ankle braces , 2 hinged models that provide free plantar flexion-dorsiflexion in the sagittal plane and 1 ankle brace without a hinge .
METHODS	Crossover study .
METHODS	University Movement Analysis Laboratory .
METHODS	Seventeen healthy volunteers ( 5 women , 12 men ; age = 25.4 4.8 years ; height = 180.3 6.5 cm ; body mass = 75.5 10.4 kg ) .
METHODS	We dynamically induced foot inversion on a tilting platform and passively induced foot movements in 6 directions via a custom-built apparatus in 3 brace conditions and a control condition ( no brace ) .
METHODS	Maximum inversion was determined dynamically using an in-shoe electrogoniometer .
METHODS	Passively induced maximal joint angles were measured using a torque and angle sensor .
METHODS	We analyzed differences among the 4 ankle-brace conditions ( 3 braces , 1 control ) for each of the dependent variables with Friedman and post hoc tests ( P < .05 ) .
RESULTS	Each ankle brace restricted dynamic foot-inversion movements on the tilting platform as compared with the control condition , whereas only the 2 hinged ankle braces differed from each other , with greater movement restriction caused by the Ankle X model .
RESULTS	Passive foot inversion was reduced with all ankle braces .
RESULTS	Passive plantar flexion was greater in the hinged models as compared with the nonhinged brace .
CONCLUSIONS	All ankle braces showed stabilizing effects against dynamic and passive foot inversion .
CONCLUSIONS	Differences between the hinged braces and the nonhinged brace did not appear to be clinically relevant .

###25371036
BACKGROUND	Untreated postoperative urinary retention can result in permanent lower urinary tract dysfunction and can be prevented by timely bladder catheterization .
BACKGROUND	The author hypothesized that the incidence of postoperative bladder catheterization can be decreased by using the patient 's own maximum bladder capacity ( MBC ) instead of a fixed bladder volume of 500 ml as a threshold for catheterization .
METHODS	Randomized parallel-arm and single-blinded comparative effectiveness trial conducted in 1,840 surgical patients , operated under general or spinal anesthesia without an indwelling urinary catheter .
METHODS	Patients were randomized to either use their individual MBC ( index ) or a fixed bladder volume of 500 ml ( control ) as a threshold for postoperative bladder catheterization .
METHODS	Preoperatively , the MBC was determined at home by voiding in a calibrated bowl .
METHODS	All other bladder volumes were measured by ultrasound .
METHODS	Postoperatively , bladder catheterization was performed when spontaneous voiding was impossible , and the ultrasound measurement exceeded the threshold for the group in which the patient was randomized ( 500 or MBC ) .
METHODS	The primary outcome was the incidence of bladder catheterization .
RESULTS	The average MBC in the control group was 582 ml ( 199 ml ) and in the index group 611 ml ( 209 ml ) .
RESULTS	The incidence of catheterization decreased from 11.8 % ( 107 of 909 patients ) in the control group to 8.6 % ( 80 of 931 ) in the index group ( relative risk 0.73 , 95 % CI 0.55 to 0.96 , P = 0.025 ) .
RESULTS	There were no adverse events in either group .
CONCLUSIONS	In patients undergoing surgery under general or spinal anesthesia using the MBC rather than a fixed 500 ml threshold for bladder catheterization is a safe approach that significantly reduces the incidence of postoperative bladder catheterizations .

###25355723
BACKGROUND	To improve the therapeutic index of whole-brain radiation therapy ( WBRT ) in the treatment of brain metastases ( BM ) from breast cancer , we investigated the efficacy and safety of WBRT combined with temozolomide ( TMZ ) in this population .
METHODS	This phase II multicenter prospective randomized study included patients with newly diagnosed intraparenchymal BMs from breast cancer , unsuitable for surgery or radiosurgery .
METHODS	All patients received conformal WBRT ( 3 Gy 10-30 Gy ) , with or without concomitant TMZ administered at a dosage of 75 mg/m ( 2 ) / day during the irradiation period .
METHODS	The primary end point was objective response rate ( ORR ) 6 weeks after the end of treatment , defined as a partial or complete response on systematic brain MRI ( modified WHO criteria ) .
METHODS	Secondary end points were progression-free survival ( PFS ) and overall survival ( OS ) , neurologic symptoms , and tolerability .
RESULTS	Between February 2008 and November 2010 , 100 patients were enrolled in the study ( 50 in the WBRT + TMZ arm , 50 in the WBRT arm ) .
RESULTS	Median age was 55 years ( 29-79 ) .
RESULTS	Median follow-up was 9.4 months [ 1.0-68 .1 ] .
RESULTS	ORRs at 6 weeks were 36 % in the WBRT arm and 30 % in the WBRT + TMZ arm ( NS ) .
RESULTS	In the WBRT arm , median PFS was 7.4 months and median OS was 11.1 months .
RESULTS	In the WBRT + TMZ arm , median PFS was 6.9 months and median OS was 9.4 months .
RESULTS	Treatment was well tolerated in this arm : the most common grade 2 acute toxicity was reversible lymphopenia .
CONCLUSIONS	WBRT combined with TMZ did not significantly improve local control and survival in patients with BMs from breast cancer .
CONCLUSIONS	CLINICALTRIALS.GOV : NCT00875355 .

###24728104
OBJECTIVE	The aim was to evaluate the agreement between and the reproducibility of transperineal and transvaginal ultrasound cervical length measurements performed by the duty obstetrical team in case of preterm labor .
OBJECTIVE	The acceptability of transperineal ultrasonography was also assessed .
METHODS	Pregnant patients between 25 and 34weeks of gestation with contractions and a clinically modified cervix were included .
METHODS	Order of ultrasonography examination ( transperineal or transvaginal first ) and rank of operator ( resident or senior ) were allocated randomly .
METHODS	Agreement was assessed using the intraclass correlation coefficient ( ICC ) and the Bland and Altman plot .
METHODS	The patient 's discomfort and preference for either method were assessed with a questionnaire .
RESULTS	62 patients admitted for preterm labor between 25 and 34weeks of gestation were included .
RESULTS	Six seniors and nine residents took part in the study .
RESULTS	Among the 51 patients with an interpretable transperineal ultrasound scan , median cervical length measurements with the transperineal and the transvaginal technique were , respectively , 25mm ( 0-53 ) and 27mm ( 4-51 ) .
RESULTS	Concordance was good with an ICC of 0.83 [ IC 95 % = ( 0.73-0 .90 ) ] .
RESULTS	Transperineal ultrasonography was preferred in 56.5 % of cases .
CONCLUSIONS	In case of preterm labor , cervical length measurement with transperineal ultrasonography seems reproducible and can be performed by the obstetric team on duty .

###25564832
OBJECTIVE	To determine if intervention school students who received skills-based breast self-exam ( BSE ) / testicular self-exam ( TSE ) training were more likely than control school students to report higher intentions to perform BSE/TSE , greater BSE/TSE self-efficacy , and actual performance of BSE/TSE .
METHODS	BSE/TSE behaviors , intentions , and self-efficacy were assessed in a high school-based trial ( N = 6 schools ; 3 schools randomized/condition ) using self-reported data at 3 time points ( N = 1058 , 9 th grade students ) .
RESULTS	At follow-up , intervention students had greater BSE/TSE intentions and self-efficacy than control students .
RESULTS	Intervention students were more likely than control students to report monthly BSE ( 54.8 % vs 27.2 % , p = .031 ) and TSE ( 81.5 % vs 31.4 % , p = .010 ) .
CONCLUSIONS	Skills-based interventions with goal setting affect teenagers ' self-examination behaviors , intentions , and self-efficacy .
CONCLUSIONS	Teaching self-screening may empower teenagers to become more engaged in their preventive health , which may lead to improved health as they age .

###24770624
BACKGROUND	Knowing how commonly used drugs affect performance monitoring is of great importance , because drug use is often associated with compromised behavioral control .
BACKGROUND	Two of the most commonly used recreational drugs in the western world , 3,4-methylenedioxymethamphetamine ( MDMA or `` ecstasy '' ) and ethanol ( alcohol ) , are also often used in combination .
BACKGROUND	The error-related negativity ( ERN ) , correct-related negativity ( CRN ) , and N2 are electrophysiological indices of performance monitoring .
OBJECTIVE	The present study aimed to investigate how ethanol , MDMA , and their co-administration affect performance monitoring as indexed by the electrophysiological correlates .
METHODS	Behavioral and EEG data were obtained from 14 healthy volunteers during execution of a speeded choice-reaction-time task after administration of ethanol , MDMA , and combined ethanol and MDMA , in a double-blind , placebo-controlled , randomized crossover design .
RESULTS	Ethanol significantly reduced ERN amplitudes , while administration of MDMA did not affect the ERN .
RESULTS	Co-administration of MDMA and ethanol did not further impair nor ameliorate the effect of ethanol alone .
RESULTS	No drug effects on CRN nor N2 were observed .
CONCLUSIONS	A decreased ERN following ethanol administration is in line with previous work and offers further support for the impairing effects of alcohol intoxication on performance monitoring .
CONCLUSIONS	This impairment may underlie maladaptive behavior in people who are under influence .
CONCLUSIONS	Moreover , these data demonstrate for the first time that MDMA does not affect performance monitoring nor does it interact with ethanol in this process .
CONCLUSIONS	These findings corroborate the notion that MDMA leaves central executive functions relatively unaffected .

###24819044
OBJECTIVE	We examined the effect of two interventions on both the reliability and validity of regulatory judgments : adjusting the regulatory instrument and attending a consensus meeting .
METHODS	We adjusted the regulatory instrument .
METHODS	With a randomized controlled trial ( RCT ) we examined the effect of the adjustments we made to the instrument .
METHODS	In the consensus meeting inspectors discussed cases and had to reach consensus about the order of the cases .
METHODS	We used a before and after case study to assess the effect of the consensus meeting .
METHODS	We compared the judgments assigned in the RCT with the unadjusted instrument with the judgments assigned with the unadjusted instrument after the consensus meeting .
METHODS	Moreover we explored the effect of increasing the number of inspectors per regulatory visit based on the estimates of the two interventions .
RESULTS	The consensus meeting improved the agreement between inspectors ; the variance between inspectors was smallest ( 0.03 ) and the reliability coefficient was highest ( 0.59 ) .
RESULTS	Validity is assessed by examining the relation between the assigned judgments and the corporate standard and expressed by a correlation coefficient .
RESULTS	This coefficient was highest after the consensus meeting ( 0.48 ) .
RESULTS	Adjustment of the instrument did not increase reliability and validity coefficients .
CONCLUSIONS	Participating in a consensus meeting improved reliability and validity .
CONCLUSIONS	Increasing the number of inspectors resulted in both higher reliability and validity values .
CONCLUSIONS	Organizing consensus meetings and increasing the number of inspectors per regulatory visit seem to be valuable interventions for improving regulatory judgments .

###24271253
BACKGROUND	Falls are a major problem in hospitals and nursing homes .
BACKGROUND	The consequences of falls can be severe , both for the individual and for the caring institution .
OBJECTIVE	The aim of the work presented here is to reduce the number of falls on a geriatric ward by monitoring patients more closely .
OBJECTIVE	To achieve this goal , a bed-exit alarm that reliably detects an attempt to get up has been constructed .
METHODS	A requirements analysis revealed the nurses ' and physicians ' needs and preferences .
METHODS	Based on the gathered information , an incremental design process generated different prototypes .
METHODS	These were tested for the reliability of their ability to detect attempts to get up in both laboratory settings and with geriatric patients .
METHODS	Based on the result of these tests , a scalable technical solution has been developed and proven its reliability in a 1-year , randomized controlled pilot clinical trial on a geriatric ward .
RESULTS	The developed system is unobtrusive and easy to deploy .
RESULTS	It has been tested in laboratory settings , usability tests and a 1-year randomized clinical trial with 98 patients .
RESULTS	This paper focuses on the technical development of the system .
RESULTS	We present different prototypes , the experiments and the pilot study used to evaluate their performance .
RESULTS	Last but not least , we discuss the lessons learned so far .
CONCLUSIONS	The developed bed-exit alarm is able to reliably detect patients ' attempts to get up .
CONCLUSIONS	The results of the clinical trial show that the system is able to reduce the number of falls on a geriatric ward .
CONCLUSIONS	Next steps are the design of a specialized sensor node that is easier to use and can be applied on an even larger scale due to its reduced cost .
CONCLUSIONS	A multicenter trial with a larger number of patients is required to confirm the results of this pilot study .

###24660585
OBJECTIVE	To determine the effects of Yishenjiangzhuo granules ( YJG ) on bone metabolism and to explore the changes in levels of bone Gla protein ( BGP ) , tartrate-resistant acid phosphatase ( TRAP ) , as well as their relationships with levels of B cells , regulatory T cells ( Treg ) and interleukin ( IL ) -17 in patients with stage 3-4 chronic kidney disease ( CKD ) before and after treatment .
METHODS	Fifty-three stage 3-4 CKD patients were divided randomly into two groups : YJG treatment and control .
METHODS	Peripheral blood was taken from two groups of CKD patients and 21 healthy subjects in the normal group .
METHODS	The parameters determined were the levels of CD4 + , CD19 + , CD19 + CD69 + , CD19 + av , Treg ( CD4 + CD25 + CD127lo ) , BGP , TRAP , IL-17 , calcium , phosphate , blood urea nitrogen , serum creatinine ( SCr ) , hemoglobin ( Hb ) in peripheral blood , and urinary creatinine .
METHODS	Calcium-phosphate products and endogenous creatinine clearance rate ( CCr ) were calculated according to standard protocols .
RESULTS	In YJG and control groups , SCr levels were lowered ( P < 0.01 ) after treatment , whereas CCr ( P < 0.05 ) as well as Hb and albumin levels ( P < 0.01 ) were increased .
RESULTS	The changes in levels of CCr and SCr in the YJG group were more significant .
RESULTS	After treatment , CD19 + CD69 + and Treg levels in the two groups varied ( P < 0.01 ) compared with those of the normal group ; the level of CD19 + increased but the levels of CD4 + and CD19 + AV decreased ( P < 0.01 ) in both groups .
RESULTS	Compared with the control group , the changes of CD19 + and CD19 + AV in the YJG group were more apparent ( P < 0.05 ) .
RESULTS	Compared with the normal group , levels of IL-17 in both groups increased significantly ( P < 0.01 ) , and the difference in the control group was more significant ( P < 0.05 ) .
RESULTS	After treatment , the TRAP level increased ( P < 0.05 ) , but the difference in BGP level ( P > 0.05 ) was not significant .
CONCLUSIONS	In stage 3-4 CKD patients , B cells and IL-17 participated in the induction of osteoclast activation .
CONCLUSIONS	YJG could also elevate the level of B cells and decrease their apoptosis , but showed no significant effects on active B cells , IL-17 or osteoclast activity .

###26206451
OBJECTIVE	To investigate whether uterus preserving vaginal sacrospinous hysteropexy is non-inferior to vaginal hysterectomy with suspension of the uterosacral ligaments in the surgical treatment of uterine prolapse .
METHODS	Multicentre randomised controlled non-blinded non-inferiority trial .
METHODS	4 non-university teaching hospitals , the Netherlands .
METHODS	208 healthy women with uterine prolapse stage 2 or higher requiring surgery and no history of pelvic floor surgery .
METHODS	Treatment with sacrospinous hysteropexy or vaginal hysterectomy with suspension of the uterosacral ligaments .
METHODS	The predefined non-inferiority margin was an increase in surgical failure rate of 7 % .
METHODS	Primary outcome was recurrent prolapse stage 2 or higher of the uterus or vaginal vault ( apical compartment ) evaluated by the pelvic organ prolapse quantification system in combination with bothersome bulge symptoms or repeat surgery for recurrent apical prolapse at 12 months ' follow-up .
METHODS	Secondary outcomes were overall anatomical recurrences , including recurrent anterior compartment ( bladder ) and/or posterior compartment ( bowel ) prolapse , functional outcome , complications , hospital stay , postoperative recovery , and sexual functioning .
RESULTS	Sacrospinous hysteropexy was non-inferior for anatomical recurrence of the apical compartment with bothersome bulge symptoms or repeat surgery ( n = 0 , 0 % ) compared with vaginal hysterectomy with suspension of the uterosacral ligaments ( n = 4 , 4.0 % , difference -3.9 % , 95 % confidence interval for difference -8.6 % to 0.7 % ) .
RESULTS	At 12 months , overall anatomical recurrences , functional outcome , quality of life , complications , hospital stay , measures on postoperative recovery , and sexual functioning did not differ between the two groups .
RESULTS	Five serious adverse events were reported during hospital stay .
RESULTS	None was considered to be related to the type of surgery .
CONCLUSIONS	Uterus preservation by sacrospinous hysteropexy was non-inferior to vaginal hysterectomy with suspension of the uterosacral ligaments for surgical failure of the apical compartment at 12 months ' follow-up .
BACKGROUND	trialregister.nl NTR1866 .

###24244703
BACKGROUND	Lifestyle interventions affect patients ' risk factors for metabolic syndrome ( MeSy ) , a pre-stage to cardiovascular diseases , diabetes and related complications .
BACKGROUND	An effective lifestyle intervention is the Swedish Bjrkns intervention , a 3-year randomized controlled trial in primary care for MeSy patients .
BACKGROUND	To include future disease-related cost and health consequences in a cost-effectiveness analysis , a simulation model was used to estimate the short-term ( 3-year ) and long-term ( lifelong ) cost-effectiveness of the Bjrkns study .
RESULTS	A Markov micro-simulation model was used to predict the cost and quality-adjusted life years ( QALYs ) for MeSy-related diseases based on ten risk factors .
RESULTS	Model inputs were levels of individual risk factors at baseline and at the third year .
RESULTS	The model estimated short-term and long-term costs and QALYs for the intervention and control groups .
RESULTS	The cost-effectiveness of the intervention was assessed using differences-in-differences approach to compare the changes between the groups in the health care and societal perspectives , using a 3 % discount rate .
RESULTS	A 95 % confidence interval ( CI ) , based on bootstrapping , and sensitivity analyses describe the uncertainty in the estimates .
RESULTS	In the short-term , costs are predicted to increase over time in both groups , but less in the intervention group , resulting in an average cost saving/reduction of US$ -700 ( in 2012 , US$ 1 = six point five seven SEK ) and US$ -500 , in the societal and health care perspectives .
RESULTS	The long-term estimate also predicts increased costs , but considerably less in the intervention group : US$ -7,300 ( 95 % CI : US$ -19,700 to US$ -1,000 ) in the societal , and US$ -1,500 ( 95 % CI : US$ -5,400 to US$ 2,650 ) in the health care perspective .
RESULTS	As intervention costs were US$ 211 per participant , the intervention would result in cost saving .
RESULTS	Furthermore , in the long-term an estimated 0.46 QALYs ( 95 % CI : 0.12 to 0.69 ) per participant would be gained .
CONCLUSIONS	The Swedish Bjrkns study appears to reduce demands on societal and health care resources and increase health-related quality of life .

###24685072
BACKGROUND	The number of routine antenatal visits provided to low risk nulliparous women has been reduced in the UK , acknowledging this change in care may result in women being less satisfied with their care and having poorer psychosocial outcomes .
BACKGROUND	The primary aim of the study was to investigate whether the provision of proactive telephone support intervention ( TSI ) with and without uterine artery Doppler screening ( UADS ) would reduce the total number of antenatal visits required .
BACKGROUND	A secondary aim was to investigate whether the interventions affected psychological outcomes .
METHODS	A three-arm randomised controlled trial involving 840 low risk nulliparous women was conducted at a large maternity unit in North East England .
METHODS	All women received antenatal care in line with current UK guidance .
METHODS	Women in the TSI group ( T ) received calls from a midwife at 28 , 33 and 36 weeks and women in the telephone and Doppler group ( T + D ) received the TSI and additional UADS at 20 weeks ' gestation .
METHODS	The main outcome measure was the total number of scheduled and unscheduled antenatal visits received after 20 weeks ' gestation .
RESULTS	The median number of unscheduled ( n = 2.0 ) , scheduled visits ( n = 7.0 ) and mean number of total visits ( n = 8.8 ) were similar in the three groups .
RESULTS	The majority ( 67 % ) of additional antenatal visits were made to a Maternity Assessment Unit because of commonly occurring pregnancy complications .
RESULTS	Additional TSI + / - UADS was not associated with differences in clinical outcomes , levels of anxiety , social support or satisfaction with care .
RESULTS	There were challenges to the successful delivery of the telephone support intervention ; 59 % of women were contacted at 29 and 33 weeks gestation reducing to 52 % of women at 37 weeks .
CONCLUSIONS	Provision of additional telephone support ( with or without UADS ) in low risk nulliparous women did not reduce the number of unscheduled antenatal visits or reduce anxiety .
CONCLUSIONS	This study provides a useful insight into the reasons why this client group attend for unscheduled visits .
BACKGROUND	ISRCTN62354584 .

###24384643
OBJECTIVE	To assess whether adding clopidogrel to acetylsalicylic acid ( ASA ) has a long-term protective vascular effect in patients with lacunar stroke while taking ASA .
METHODS	Post hoc analysis of 838 patients with ASA failure and recent lacunar stroke from the Secondary Prevention of Small Subcortical Strokes Trial ( SPS3 ) cohort randomly allocated to aspirin ( 325 mg/day ) and clopidogrel ( 75 mg/day ) or placebo .
METHODS	Primary efficacy outcome was stroke recurrence ( ischemic and intracranial hemorrhage ) and main safety outcome was major extracranial hemorrhage .
METHODS	Patients were followed for a mean period of 3.5 years .
RESULTS	The ASA failure group had a significantly higher risk of vascular events including ischemic stroke when compared with the non-ASA failure group ( n = 2,151 ) in SPS3 ( p = 0.03 ) .
RESULTS	Mean age was 65.6 years and 65 % were men .
RESULTS	The risk of recurrent stroke was not reduced in the dual antiplatelet group , 3.1 % per year , compared to the aspirin-only group , 3.3 % per year ( hazard ratio [ HR ] 0.91 ; 95 % confidence interval [ CI ] 0.61-1 .37 ) .
RESULTS	There was also no difference between groups for ischemic stroke ( HR 0.90 ; 95 % CI 0.59-1 .38 ) .
RESULTS	The risk of gastrointestinal bleeding was higher in the dual antiplatelet group ( HR 2.7 ; 95 % CI 1.1-6 .9 ) ; however , the risk of intracranial hemorrhage was not different .
CONCLUSIONS	In patients with a recent lacunar stroke while taking ASA , the addition of clopidogrel did not result in reduction of vascular events vs continuing ASA only .
METHODS	This study provides Class I evidence that for patients with recent lacunar stroke while taking ASA , adding clopidogrel as compared to continuing ASA alone does not reduce the risk of recurrent stroke .

###25004345
OBJECTIVE	To describe the perinatal and infant and early childhood morbidity associated with preterm premature rupture of membranes ( PROM ) in a cohort of twin pregnancies evaluated prospectively with neonatal follow-up to 2 years of age .
METHODS	This was a secondary analysis of a randomized controlled trial of magnesium sulfate for prevention of cerebral palsy .
METHODS	Inclusion criteria were twin gestation with preterm PROM diagnosed between 24 0/7 and 31 6/7 weeks of gestation and planned expectant management .
METHODS	Latency ( time from membrane rupture to delivery ) and perinatal outcomes were evaluated by gestational age at membrane rupture .
METHODS	Long-term neonatal outcomes were also analyzed .
RESULTS	Among 151 women who met inclusion criteria , the median gestational age at preterm PROM was 28.1 weeks ( range 24.1-31 .6 weeks ) .
RESULTS	Approximately one-third of women achieved a latency of at least 1 week .
RESULTS	Gestational age at preterm PROM ( odds ratio [ OR ] 0.75 , 95 % confidence interval [ CI ] 0.63-0 .90 for each week after 24 weeks of gestation ) and cervical dilation at admission ( OR 0.66 , 95 % CI 0.49-0 .90 for each centimeter of dilation ) were inversely associated with a latency period of at least 1 week .
RESULTS	There were no stillbirths ( 95 % CI 0-1 % ) , but the rate of neonatal mortality was 90 per 1,000 newborns ( 95 % CI 57-112 ) with a 7.3 % cerebral palsy rate among survivors ( 95 % CI 4.4-10 .3 % ) .
CONCLUSIONS	In twin pregnancies , preterm PROM from 24 to 31 weeks of gestation is associated with a neonatal mortality rate of 9.0 % and an overall cerebral palsy rate of 7.3 % .
CONCLUSIONS	A longer latency period is associated with less advanced cervical dilation and later gestational age at PROM .
CONCLUSIONS	LEVEL OF EVIEDENCE : II .

###25676529
OBJECTIVE	In the EINSTEIN DVT and EINSTEIN PE studies , the majority of patients received heparins to bridge the period during venous thromboembolism ( VTE ) diagnosis confirmation and the start of the study .
OBJECTIVE	In contrast to vitaminK antagonists ( VKAs ) , rivaroxaban may not require initial heparin treatment .
METHODS	To evaluate the effect of prestudy heparin on the efficacy and safety of rivaroxaban relative to enoxaparin/VKA , the 3-month incidence of recurrent VTE , and the 14-day incidence of major and nonmajor clinically relevant bleeding were compared in patients who did and did not receive prestudy heparin .
RESULTS	Of the 8,281 patients randomized , 6,937 ( 83.8 % ) received prestudy heparin ( mean SD duration = rivaroxaban : 1.04 [ 0.74 ] days ; enoxaparin 1.03 [ 0.42 ] days ) , and 1,344 ( 16.2 % ) did not .
RESULTS	In patients who did not receive prestudy heparin , the incidences of recurrent VTE were similar in rivaroxaban ( 15 of 649 , 2.3 % ) and enoxaparin/VKA ( 13 of 695 , 1.9 % ) patients ( adjusted hazard ratio [ HR ] = 1.11 ; 95 % confidence interval [ CI ] = 0.52 to 2.37 ) .
RESULTS	The incidences of recurrent VTE were also similar in rivaroxaban ( 54 of 3,501 , 1.5 % ) and enoxaparin/VKA ( 69 of 3,436 , 2.0 % ) patients who did receive prestudy heparin ( adjusted HR = 0.74 ; 95 % CI = 0.52 to 1.06 ; pinteraction = 0.32 ) .
RESULTS	The incidences of major or nonmajor clinically relevant bleeding with rivaroxaban were not significantly different from those with enoxaparin/VKA , either with ( 105 of 3,485 , 3.0 % vs. 104 of 3,428 , 3.0 % ; adjusted HR = 0.98 ; 95 % CI = 0.75 to 1.29 ) or without ( 24 of 645 , 3.7 % vs. 30 of 688,4.4 % ; adjusted HR = 0.81 ; 95 % CI = 0.46 to 1.40 ; pinteraction = 0.68 ) prestudy heparin .
CONCLUSIONS	Although the majority of patients in the EINSTEIN studies received prestudy heparin , there were no notable differences in treatment effect of rivaroxaban versus enoxaparin/VKA in those who did and did not receive it .

###26241428
OBJECTIVE	To compare , in an unselected population of nulliparous pregnant women , the postnatal effect of prenatal supervised pelvic floor muscle training with written instructions on postpartum urinary incontinence ( UI ) .
METHODS	In a randomized controlled trial in two parallel groups , 282 women were recruited from five university teaching hospitals in France and randomized during the second trimester of pregnancy .
METHODS	The physiotherapy group received prenatal individually supervised exercises .
METHODS	Both groups received written instructions about how to perform exercises at home .
METHODS	Women were blindly assessed at baseline , end of pregnancy , and 2 and 12 months postpartum .
METHODS	The primary outcome measured was UI severity , assessed with an International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form score ( range 0-21 ; 1-5 is slight UI ) at 12 months postpartum ; other outcomes were UI prevalence and pelvic floor troubles assessed using self-administered questionnaires .
METHODS	To give a 1-point difference in UI severity score , we needed 91 women in each group ( standard deviation 2.4 , = 0.05 , = 0.20 , and bilateral analysis ) .
RESULTS	Between February 2008 and June 2010 , 140 women were randomized in the physiotherapy group and 142 in the control group .
RESULTS	No difference was observed between the two groups in UI severity , prevalence , or pelvic floor troubles at baseline , end of pregnancy , and at 2 and 12 months postpartum .
RESULTS	At 12 months postpartum , the primary outcome was available for 190 women ( 67.4 % ) ; mean UI severity was 1.9 in the physiotherapy group compared with 2.1 in the control group ( P = .38 ) .
CONCLUSIONS	Prenatal supervised pelvic floor training was not superior to written instructions in reducing postnatal UI .
BACKGROUND	ClinicalTrials.gov ; www.clinicaltrials.gov , NCT00551551 .
METHODS	I.

###25694417
BACKGROUND	Human epidermal growth factor receptor 2 ( HER2 ) amplification is present in a subgroup of gastroo-esophageal cancers ( GCs ) .
BACKGROUND	HER2 inhibition with trastuzumab has shown to improve outcomes in advanced disease .
BACKGROUND	Lapatinib ditosylate ( LAP ) , a dual anti-epidermal growth factor receptor ( EGFR ) and anti-HER2 tyrosine kinase inhibitor with preclinical activity against GC , has been approved in HER2-positive breast cancer .
BACKGROUND	We aimed to study the activity of LAP in HER2-amplified GC .
METHODS	Patients ( pts ) with HER2-positive ( gene amplification or increased copy numbers based on predefined criteria ) advanced GC were randomly allocated 1:1 to receive LAP 1250mg per day 1-21 plus capecitabine ( CAP ) 2000mg/m ( 2 ) on days 1-14 of a 21-day cycle or LAP 1500mg monotherapy day 1-21 after having failed on a platinum-based first-line therapy .
METHODS	HER2 status was assessed centrally .
METHODS	The primary end-point was the objective response rate ( ORR ) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors ( RECIST , version 1.1 ) .
METHODS	We aimed to include 38 pts per arm to show an interesting response rate of 20 % in either of the two arms .
RESULTS	37 pts were enrolled ( 18 to LAP+CAP , 19 to LAP ) .
RESULTS	Pts had received a median of three prior treatment lines .
RESULTS	12 pts in the LAP+CAP group ( 67 % ) and 12 pts in the LAP group ( 63 % ) had received prior trastuzumab .
RESULTS	Only two pts ( 11.1 % ; 95 % confidence interval ( CI ) : 1.37-34 .7 ) , both in the LAP+CAP arm , achieved an objective response .
RESULTS	The study was closed prematurely for futility .
RESULTS	Median time to progression was 42 ( 95 % CI : 38-61 ) days in the LAP group and 83 ( 95 % CI : 42-86 ) days in the LAP+CAP group .
RESULTS	Other secondary efficacy end-points ( progression-free and overall survival ) were comparable in the two treatment groups .
RESULTS	Rates of diarrhoea were higher with LAP+CAP ( 61 % ; 95 % CI : 35-83 ) compared to 26 % ( 95 % CI 9-51 ) with LAP mono , whereas other adverse events were mostly similar between the groups ( 18 [ 100 % ] versus 17 [ 90 % ] ) .
CONCLUSIONS	Lapatinib showed insufficient activity in HER2-amplified pretreated advanced GC .
CONCLUSIONS	The safety profile of LAP or LAP+CAP was as expected with some more toxicity in the combination arm .
CONCLUSIONS	( ClinicalTrials.gov Identifier , NCT01145404 ) .

###24280948
OBJECTIVE	To determine if infrared laser acupuncture ( LA ) may have a specific effect in reducing pain and disability in treatment of chronic low back pain ( LBP ) .
METHODS	This was a double-blind sham laser controlled trial performed in general practices in Perth , Western Australia .
METHODS	The participants were 144 adults with chronic non-specific LBP .
METHODS	They were randomised to receive eight once-weekly treatments .
METHODS	Laser machines ( 20 mW , 840 nm diode , power density 0.1 W/cm ( 2 ) ) stimulated points in three treatment groups : sham ( 0 joules/point ) , low dose ( 0.2 J/point ) and high dose ( 0.8 joules/point ) .
METHODS	Participants were followed-up at 1 and 6 weeks , and 6 and 12 months post treatment .
METHODS	Primary outcomes were pain ( Numerical Pain Rating Scale ( NPRS ) ) and disability ( Oswestry Disability Inventory ( ODI ) ) at 6 weeks post treatment .
METHODS	Secondary outcomes included numerical rating scale for limitation of activity , global assessment of improvement , analgesic usage and adverse effects after treatment .
RESULTS	The analysis showed no difference between sham and the laser groups at 6 weeks for pain or disability .
RESULTS	There was a significant reduction in mean pain and disability in all groups at 6 weeks ( p < 0.005 ) ; NPRS : sham ( -1.5 ( 95 % CI -2.1 to -0.8 ) ) , low dose ( -1.3 ( -2.0 to -0.8 ) ) , high dose ( -1.1 ( -1.7 to -0.5 ) ) .
RESULTS	ODI : sham ( -4.0 ( -7.1 to -1.0 ) ) , low dose ( -4.1 , ( -6.7 to -1.5 ) ) , high dose ( -2.6 ( -5.7 to 0.5 ) ) .
RESULTS	All secondary outcomes also showed clinical improvement over time but with no differences between groups .
CONCLUSIONS	LA using energy density range ( 0-4 J/cm ( 2 ) ) for the treatment of chronic non-specific LBP resulted in clinical improvement unrelated to laser stimulation .
BACKGROUND	http://www.anzctr.org.au ACTRN12610000043033 .

###25185628
OBJECTIVE	Pelvic floor physical therapy ( PFPT ) is often used as a treatment of pelvic floor disorders and may improve function after pelvic reconstructive surgery .
OBJECTIVE	However , the long-term impact of this modality is not understood .
METHODS	This randomized controlled trial compared PFPT to the standard care in women undergoing vaginal reconstruction .
METHODS	The intervention group received PFPT biweekly until 12 weeks postoperatively , in conjunction with a physician assessment .
METHODS	Control subjects underwent a physician assessment alone at all postoperative intervals .
METHODS	The final follow-up was at 24 weeks .
METHODS	Physical examinations ( pelvic organ prolapse quantification assessment ) , intravaginal electromyography , voiding diaries , and validated questionnaires were completed by all subjects .
METHODS	The primary outcome was change in the World Health Organization Quality of Life-BREF .
RESULTS	Forty-nine women completed the study , 24 in the PFPT group and 25 in the control group .
RESULTS	Although electromyography measures showed better muscular function in PFPT subjects after 12 weeks , at 6 months after surgery , this was no longer noted .
RESULTS	However , quality of life parameters improved for the entire sample at 24 weeks , with no difference between groups .
RESULTS	Positive change from 12 to 24 weeks was also documented in scores on the Pelvic Floor Distress Inventory-20 ( P = 0.04 ) and Pelvic Floor Impact Questionnaire-7 ( P = 0.018 ) , corresponding with continued improvement in bladder symptoms .
RESULTS	Finally , Prolapse and Incontinence Sexual Questionnaire-12 and Female Sexual Function Index scores improved between 12 and 24 weeks , suggesting better sexual function overall with time elapsed from surgery .
CONCLUSIONS	Quality of life improves in all subjects after vaginal reconstructive surgery , with ongoing benefit between 3 and 6 months .
CONCLUSIONS	Nevertheless , standardized PFPT was not associated with differences at 24 weeks in this cohort of women .

###25029914
METHODS	Prospective , randomized , controlled single-blind intervention trial .
OBJECTIVE	Shock-absorbing insoles ( SAIs ) , compared with usual insoles , were hypothesized to result in larger increases in pressure pain threshold ( PPT ) after 3 weeks of use .
BACKGROUND	Shock-absorbing insoles can decrease self-reported pain among young soccer players training on artificial turf .
BACKGROUND	However , nothing is known about the underlying changes in pain sensitivity assessed by PPT .
BACKGROUND	Methods Seventy-five players were included from the youth teams of under 15 , under 17 , and under 19 years of age , playing for the Aalborg Boldspilklub ( AaB ) professional sports club .
BACKGROUND	After a randomization stratified by team and age , players were divided into 2 groups , one that received SAIs and a control group that used their usual insoles .
BACKGROUND	Assessments were made in both groups after 3 weeks of training on artificial turf ( baseline ) and 3 weeks later ( follow-up ) .
BACKGROUND	The primary outcome was change in PPTs from baseline to follow-up , with PPTs measured over 13 locations on the plantar surface of the foot , leg , and low back of the nonpreferred kicking leg .
RESULTS	A significantly larger increase was found in PPTs from baseline to follow-up for the SAI group compared with the control group ( mean difference , 62 kPa ; 95 % confidence interval [ CI ] : 40 , 85 kPa ) .
RESULTS	The PPTs increased significantly more among the SAI group compared with the control group ( P < .05 ) for the abductor digiti minimi ( mean difference , 82 kPa ; 95 % CI : 6 , 157 kPa ) , tibialis anterior ( mean difference , 125 kPa ; 95 % CI : 20 , 230 kPa ) , medial gastrocnemius ( mean difference , 83 kPa ; 95 % CI : -6 , 171 kPa ) , and erector spinae ( mean difference , 86 kPa ; 95 % CI : -17 , 188 kPa ) .
CONCLUSIONS	The use of SAIs resulted in increased PPTs after 3 weeks of training on artificial turf compared with controls , suggesting a protective role of SAIs in pressure sensitivity and pain perception .

###25858972
BACKGROUND	The effectiveness of risk stratification for low back pain ( LBP ) management has not been demonstrated in outpatient physical therapy settings .
OBJECTIVE	The purposes of this study were : ( 1 ) to assess implementation of a stratified care approach for LBP management by evaluating short-term treatment effects and ( 2 ) to determine feasibility of conducting a larger-scale study .
METHODS	This was a 2-phase , preliminary study .
METHODS	In phase 1 , clinicians were randomly assigned to receive standard ( n = 6 ) or stratified care ( n = 6 ) training .
METHODS	Stratified care training included 8 hours of content focusing on psychologically informed practice .
METHODS	Changes in LBP attitudes and beliefs were assessed using the Pain Attitudes and Beliefs Scale for Physiotherapists ( PABS-PT ) and the Health Care Providers Pain and Impairment Relationship Scale ( HC-PAIRS ) .
METHODS	In phase 2 , clinicians receiving the stratified care training were instructed to incorporate those strategies in their practice and 4-week patient outcomes were collected using a numerical pain rating scale ( NPRS ) , and the Oswestry Disability Index ( ODI ) .
METHODS	Study feasibility was assessed to identify potential barriers for completion of a larger-scale study .
RESULTS	In phase 1 , minimal changes were observed for PABS-PT and HC-PAIRS scores for standard care clinicians ( Cohen d = 0.00-0 .28 ) .
RESULTS	Decreased biomedical ( -4.52.5 points , d = 1.08 ) and increased biopsychosocial ( +5.52.0 points , d = 2.86 ) treatment orientations were observed for stratified care clinicians , with these changes sustained 6 months later on the PABS-PT .
RESULTS	In phase 2 , patients receiving stratified care ( n = 67 ) had greater between-group improvements in NPRS ( 0.8 points ; 95 % confidence interval = 0.1 , 1.5 ; d = 0.40 ) and ODI ( 8.9 % points ; 95 % confidence interval = 4.1 , 13.6 ; d = 0.76 ) scores compared with patients receiving standard physical therapy care ( n = 33 ) .
CONCLUSIONS	In phase 2 , treatment was not randomly assigned , and therapist adherence to treatment recommendations was not monitored .
CONCLUSIONS	This study was not adequately powered to conduct subgroup analyses .
CONCLUSIONS	In physical therapy settings , biomedical orientation can be modified , and risk-stratified care for LBP can be effectively implemented .
CONCLUSIONS	Findings from this study can be used for planning of larger studies .

###24973924
OBJECTIVE	The Saphenous Vein Versus Right Internal Thoracic Artery as a Y-Composite Graft ( SAVE RITA ) trial was designed to evaluate the noninferiority of the saphenous vein ( SV ) compared with the right internal thoracic artery ( [ R ] ITA ) used as a Y-composite graft .
METHODS	A total of 224 patients who had undergone off-pump revascularization for multivessel coronary artery disease using the SV or RITA as a Y-composite graft based on the in situ left ITA were assigned randomly to the SV Y-composite graft ( SV group , n = 112 ) or free RITA Y-composite graft ( RITA group , n = 112 ) .
METHODS	The primary endpoint was the 1-year angiographic patency rate of the second limb conduits ( SV or RITA ) .
METHODS	Postoperative 1-year coronary angiograms were performed in 215 patients ( SV group , 108 ; RITA group , 107 ) .
RESULTS	The overall graft patency rate was 97.4 % ( 745 of 765 ) at 1 year ( 97.9 % in the SV group vs 96.9 % in the RITA group , P = .362 ) .
RESULTS	The primary endpoint of the study , the 1-year patency rate of the SV composite grafts , was 97.1 % ( 238 of 245 ) and was noninferior to that of the RITA composite grafts ( 97.1 % [ 198 of 204 ] ) with a 95 % lower confidence limit of -2.6 % ( P < .001 for noninferiority ) .
RESULTS	The graft qualities , evaluated using the FitzGibbon patency grades , were also similar between the 2 groups ( P = .948 ) .
RESULTS	No statistically significant differences were found in the overall survival rates between the 2 groups at 1 and 4 years ( P = .998 ) .
RESULTS	Also , no statistically significant differences were found between the 2 groups in the freedom from major adverse cardiac and cerebrovascular event rates at 1 and 4 years ( P = .597 ) .
CONCLUSIONS	The SV composite grafts were noninferior to the RITA composite grafts in terms of the 1-year angiographic patency rates .

###24332521
OBJECTIVE	The control of bleeding after tooth extraction is a major concern in patients taking warfarin .
OBJECTIVE	Light-emitting diode ( LED ) irradiation with hemostatic gelatin sponge application was investigated .
METHODS	Patients who took warfarin and required tooth extraction were divided randomly into 3 groups .
METHODS	The first group was irradiated with blue-violet LED after tooth extraction .
METHODS	The second group was treated with a hemostatic gelatin sponge and LED irradiation .
METHODS	The third group was treated with only hemostatic gelatin sponges .
METHODS	Hemostasis was evaluated at 30 seconds after treatment .
RESULTS	Less than 30 % of the patients achieved hemostasis within 30 seconds in the hemostatic sponge group ; approximately 50 % of the patients in the simple LED irradiation group achieved hemostasis within 30 seconds ; and 86.7 % of the patients in the LED and hemostatic sponge combined group achieved hemostasis within 30 seconds , indicating that combined treatment with LED and hemostatic sponges provided a significantly higher hemostasis than in the hemostatic sponge group ( P < .01 ) .
CONCLUSIONS	Blue-violet LED irradiation combined with hemostatic gelatin sponge treatment yielded hemostasis of the extraction socket within 30 seconds without suture in most cases .

###25453518
BACKGROUND	It is unknown whether diets with a high dietary total antioxidant capacity ( TAC ) can modify oxidative stress , low-grade inflammation , or liver dysfunction , all of which are risk factors for multiple sclerosis disease .
BACKGROUND	This study assesses alanine amino-transferase ( ALT ) , aspartate-aminotransferase ( AST ) and gamma-glutamyl transferase ( GGT ) activities in MS patients treated with co-supplemented hemp seed and evening primrose oils as well as Hot-nature diet and the therapeutic potential this intervention .
METHODS	In this double blind , randomized trial , 100 MS patients with EDSS < 6 were allocated into 3 groups : `` group A '' , who received co-supplemented hemp seed and evening primrose oils with advised Hot-nature diet ; `` group B '' , who received olive oil ; and `` group C '' , who received the co-supplemented oils .
METHODS	Clinically , EDSS as well as serum level of liver enzymes ( GGT , AST , and ALT ) were assessed at baseline and after 6 months .
RESULTS	Mean follow-up was 1802.9 SD days ( N = 65 , 23 M and 42 F aged 34.258.07 years with disease duration of 6.804.33 years ) .
RESULTS	There was no significant difference in the study parameters at baseline .
RESULTS	Serum levels of liver enzymes ( GGT , AST , and ALT ) were serially monitored .
RESULTS	Intervention was associated with liver function alteration in three groups .
RESULTS	Significance decreased in EDSS score and the levels of liver enzymes were found in groups A and C , whereas elevated serum liver enzymes and EDSS score were observed in group B after the intervention .
CONCLUSIONS	Selecting foods according to their Total antioxidant capacity such as co-supplemented hemp seed and evening primrose oils with Hot-nature diet affects antioxidant intake and can have beneficial effects on improving EDSS score and activity of liver enzymes in RRMS patients .

###26010632
OBJECTIVE	Soy isoflavone supplements are used to treat several chronic diseases , although the data supporting their use are limited .
OBJECTIVE	Some data suggest that supplementation with soy isoflavone may be an effective treatment for patients with poor asthma control .
OBJECTIVE	To determine whether a soy isoflavone supplement improves asthma control in adolescent and adult patients with poorly controlled disease .
METHODS	Multicenter , randomized , double-blind , placebo-controlled trial conducted between May 2010 and August 2012 at 19 adult and pediatric pulmonary and allergy centers in the American Lung Association Asthma Clinical Research Centers network .
METHODS	Three hundred eighty-six adults and children aged 12 years or older with symptomatic asthma while taking a controller medicine and low dietary soy intake were randomized , and 345 ( 89 % ) completed spirometry at week 24 .
METHODS	Participants were randomly assigned to receive soy isoflavone supplement containing 100 mg of total isoflavones ( n = 193 ) or matching placebo ( n = 193 ) in 2 divided doses administered daily for 24 weeks .
METHODS	The primary outcome measure was change in forced expiratory volume in the first second ( FEV1 ) at 24 weeks .
METHODS	Secondary outcome measures were symptoms , episodes of poor asthma control , Asthma Control Test score ( range , 5-25 ; higher scores indicate better control ) , and systemic and airway biomarkers of inflammation .
RESULTS	Mean changes in prebronchodilator FEV1 over 24 weeks were 0.03 L ( 95 % CI , -0.01 to 0.08 L ) in the placebo group and 0.01 L ( 95 % CI , -0.07 to 0.07 L ) in the soy isoflavone group , which were not significantly different ( P = .36 ) .
RESULTS	Mean changes in symptom scores on the Asthma Control Test ( placebo , 1.98 [ 95 % CI , 1.42-2 .54 ] vs soy isoflavones , 2.20 [ 95 % CI , 1.53-2 .87 ] ; positive values indicate a reduction in symptoms ) , number of episodes of poor asthma control ( placebo , 3.3 [ 95 % CI , 2.7-4 .1 ] vs soy isoflavones , 3.0 [ 95 % CI , 2.4-3 .7 ] ) , and changes in exhaled nitric oxide ( placebo , -3.48 ppb [ 95 % CI , -5.99 to -0.97 ppb ] vs soy isoflavones , 1.39 ppb [ 95 % CI , -1.73 to 4.51 ppb ] ) did not significantly improve more with the soy isoflavone supplement than with placebo .
RESULTS	Mean plasma genistein level increased from 4.87 ng/mL to 37.67 ng/mL ( P < .001 ) in participants receiving the supplement .
CONCLUSIONS	Among adults and children aged 12 years or older with poorly controlled asthma while taking a controller medication , use of a soy isoflavone supplement , compared with placebo , did not result in improved lung function or clinical outcomes .
CONCLUSIONS	These findings suggest that this supplement should not be used for patients with poorly controlled asthma .
BACKGROUND	clinicaltrials.gov Identifier : NCT01052116 .

###25980737
BACKGROUND	The increasing investment in malaria rapid diagnostic tests ( RDTs ) to differentiate malarial and non-malarial fevers , and an awareness of the need to improve case management of non-malarial fever , indicates an urgent need for high quality evidence on how best to improve prescribers ' practices .
METHODS	A three-arm stratified cluster-randomised trial was conducted in 36 primary healthcare facilities from September 2010 to March 2012 within two rural districts in northeast Tanzania where malaria transmission has been declining .
METHODS	Interventions were guided by formative mixed-methods research and were introduced in phases .
METHODS	Prescribing staff from all facilities received standard Ministry of Health RDT training .
METHODS	Prescribers from facilities in the health worker ( HW ) and health worker-patient ( HWP ) arms further participated in small interactive peer-group training sessions with the HWP additionally receiving clinic posters and patient leaflets .
METHODS	Performance feedback and motivational mobile-phone text messaging ( SMS ) were added to the HW and HWP arms in later phases .
METHODS	The primary outcome was the proportion of patients with a non-severe , non-malarial illness incorrectly prescribed a ( recommended ) antimalarial .
METHODS	Secondary outcomes investigated RDT uptake , adherence to results , and antibiotic prescribing .
RESULTS	Standard RDT training reduced pre-trial levels of antimalarial prescribing , which was sustained throughout the trial .
RESULTS	Both interventions significantly lowered incorrect prescribing of recommended antimalarials from 8 % ( 749/8 ,942 ) in the standard training arm to 2 % ( 250/10 ,118 ) in the HW arm ( adjusted RD ( aRD ) 4 % ; 95 % confidence interval ( CI ) 1 % to 6 % ; P = 0.008 ) and 2 % ( 184/10 ,163 ) in the HWP arm ( aRD 4 % ; 95 % CI 1 % to 6 % ; P = 0.005 ) .
RESULTS	Small group training and SMS were incrementally effective .
RESULTS	There was also a significant reduction in the prescribing of antimalarials to RDT-negatives but no effect on RDT-positives receiving an ACT .
RESULTS	Antibiotic prescribing was significantly lower in the HWP arm but had increased in all arms compared with pre-trial levels .
CONCLUSIONS	Small group training with SMS was associated with an incremental and sustained improvement in prescriber adherence to RDT results and reducing over-prescribing of antimalarials to close to zero .
CONCLUSIONS	These interventions may become increasingly important to cope with the wider range of diagnostic and treatment options for patients with acute febrile illness in Africa .

###25543418
OBJECTIVE	To observe and evaluate the clinical effect of acupuncture at `` Siguan '' combined with the Gallbladder Meridian acupoints on migraine .
METHODS	With randomized controlled trial design , 87 patients were randomly divided into an observation group ( 42 cases ) and a control group ( 45 cases ) .
METHODS	The observation group was treated with acupuncture at `` Siguan '' including Hegu ( LI 4 ) and Taichong ( LR 3 ) , combined with the Gallbladder Meridian acupoints including Fengchi ( GB 20 ) , Shuaigu ( GB 8 ) , Qiuxu ( GB 40 ) and Zulinqi ( GB 41 ) , while the control group was treated with acupuncture at the Gallbladder Meridian acupoints , including Fengchi ( GB 20 ) , Shuaigu ( GB 8 ) , Qiuxu ( GB 40 ) , Zulinqi ( GB 41 ) , Yanglingquan ( GB 34 ) and Hanyan ( GB 4 ) .
METHODS	The treatment was given every other day in two groups , 3 times per week for totally 6 weeks .
METHODS	The migraine intensity , migraine frequency and lasting time of each migraine were observed before and after treatment , and 3-month follow-up was performed after treatment .
METHODS	The clinical efficacy in two groups was evaluated .
RESULTS	Compared with those before treatment , the migraine intensity , frequency and lasting time were all reduced significantly after treatment in the two groups ( all P < 0.01 ) , which were more obvious in the observation group ( all P < 0.05 ) .
RESULTS	At the end of the treatment , the total effective rate was 95.2 % ( 40/42 ) in the observation group and 80.0 % ( 36/45 ) in the control group , which had statistical difference ( P < 0.05 ) .
RESULTS	After 3-month follow-up , the total effective rate was 88.1 % ( 37/42 ) in the observation group and 75.6 % ( 34/45 ) in the control group , which had no statistical difference ( P > 0.05 ) .
CONCLUSIONS	The `` Siguan '' combined with the Gallbladder Meridian acupoints could significantly relieve the migraine intensity , frequency and lasting time , and its improvement of symptoms and short-term efficacy are superior to those of the Gallbladder Meridian acupoints alone .

###24559846
OBJECTIVE	Inflammation , insulin resistance and vascular dysfunction characterize obesity and predict development of cardiovascular disease ( CVD ) .
OBJECTIVE	Although women experience CVD events at an older age , vascular dysfunction is evident 10years prior to coronary artery disease .
OBJECTIVE	Questions remain whether replacing SFA entirely with MUFA or PUFA is the optimal approach for cardiometabolic benefits .
OBJECTIVE	This study tested the hypotheses that : a ) body composition , inflammation and vascular function would improve with a high fat diet ( HFD ) when type of fat is balanced as 1/3 SFA , 1/3 MUFA and 1/3 PUFA ; and b ) body composition , inflammation and vascular function would improve more when balanced HFD is supplemented with 18C fatty acids , in proportion to the degree of 18C unsaturation .
METHODS	Obese premenopausal women were stabilized on balanced HFD and randomized to consume 9g/d of encapsulated stearate ( 18:0 ) , oleate ( 18:1 ) , linoleate ( 18:2 ) or placebo .
RESULTS	Significant improvements occurred in fat oxidation rate ( 6 % ) , body composition ( % fat : 2.52.1 % ; % lean : 2.52.1 % ) , inflammation ( IL-1 , IL-1 , 1L-12 , Il-17 , IFN , TNF , TNF ) and vascular function ( BP , PAI-1 , tPA activity ) .
RESULTS	When compared to HFD + placebo , HFD + stearate had the greatest effect on reducing IFN ( 74 % ) and HFD + linoleate had the greatest effect on reducing PAI-1 ( 31 % ) .
CONCLUSIONS	Balancing the type of dietary fat consumed ( SFA/MUFA/PUFA ) is a feasible strategy to positively affect markers of CVD risk .
CONCLUSIONS	Moreover , reductions in inflammatory molecules involved in vascular function might be enhanced when intake of certain 18C fatty acids is supplemented .
CONCLUSIONS	Long term effects need to be determined for this approach .

###24639426
OBJECTIVE	The effects of cholesteryl ester transfer protein ( CETP ) inhibition on lipids , inflammation , and markers of high-density lipoprotein ( HDL ) function , following an acute coronary syndrome ( ACS ) , are unknown .
RESULTS	The dal-ACUTE study randomized 300 patients ( 1 : 1 ) to dalcetrapib 600 mg/day or placebo within 1 week of an ACS .
RESULTS	The primary endpoint was per cent change in HDL-cholesterol ( HDL-C ) after 4 weeks .
RESULTS	Secondary endpoints included apolipoprotein levels , markers of HDL function , and inflammation .
RESULTS	Dalcetrapib treatment increased HDL-C and apolipoprotein A1 by 33.7 and 11.8 % , respectively ( both P < 0.001 ) and total cholesterol efflux by 9.5 % ( P = 0.003 ) after 4 weeks , principally via an increase in non-ATP-binding cassette transporter ( ABC ) A1-mediated efflux , without statistically significant changes in pre-1-HDL levels .
RESULTS	The increase in total efflux with dalcetrapib correlated most strongly with increases in apolipoprotein A1 and HDL-C ( r = 0.46 and 0.43 , respectively ) rather than the increase in pre-1-HDL ( r = 0.32 ) .
RESULTS	Baseline and on-treatment ABCA1-mediated efflux correlated most strongly with pre-1-HDL levels ; in contrast , non-ABCA1-mediated efflux correlated better with apolipoprotein A1 and HDL-C levels .
CONCLUSIONS	High-density lipoprotein raised through CETP inhibition with dalcetrapib improves cholesterol efflux , principally via a non-ABCA1-mediated pathway .
CONCLUSIONS	While HDL-C was increased by one-third , apolipoprotein A1 and total efflux were increased only by one-tenth , supporting the concept of dissociation between improvements in HDL function and HDL-C levels , which may be of relevance to ongoing trials and the development of therapeutic interventions targeting HDL .

###24772445
OBJECTIVE	This study was designed to compare the effects of metformin and repaglinide on the fasting plasma glucose ( FPG ) and glycated haemoglobin ( HbA1c ) in newly diagnosed type 2 diabetes in China .
METHODS	A total of 107 newly diagnosed type 2 diabetic patients ( 46 women and 61 men ) participated in the study .
METHODS	All patients received 3-month treatment of metformin or repaglinide .
METHODS	Fasting blood glucose and HbA1c were determined at baseline and at the end of the 3-month of treatment .
RESULTS	FPG and HbA1c decreased in both metformin and repaglinide groups after 3 months treatment ( P < 0.01 ) .
RESULTS	The reduction of HbA1c was significantly greater in the repaglinide group ( P < 0.01 ) .
RESULTS	Metformin decreases fasting insulin concentration and HOMA-IR ( P < 0.01 ) , and repaglinide improves HOMA - ( P < 0.01 ) .
RESULTS	Triglycerides ( TG ) were reduced in both groups ( P < 0.01 in metformin group ; P < 0.05 in repaglinide group ) , but total cholesterol ( TC ) and low-density lipoprotein ( LDL ) were decreased only after metformin treatment ( P < 0.05 ) .
CONCLUSIONS	Both repaglinide and metformin were effective in glycaemic control in new onset patients with type 2 diabetes in China .
CONCLUSIONS	Repaglinide had no effect on insulin sensitivity , but it improved - cell function .

###25542267
OBJECTIVE	The potential effect of onartuzumab , when administered with or without bevacizumab in combination with weekly paclitaxel , on the corrected QT interval ( QTc ) and other electrocardiogram ( ECG ) parameters , was investigated in a randomized , phase 2 study OAM4861g of first - or second-line therapy in patients with locally recurrent or metastatic triple-negative breast cancer .
METHODS	Triplicate 12-lead ECGs were recorded at screening , pre - and post-dose on day 1 of cycles 1 , 2 , and 4 , and at the study drug discontinuation visit ( SDDV ) .
METHODS	Onartuzumab serum samples were collected pre - and post-dose on day 1 of cycles 1-4 and at the SDDV .
METHODS	Fridericia 's correction was applied to QT recordings ( QTcF ) , and change from baseline ( QTcF ) was calculated .
METHODS	Post-baseline measurements were reported as baseline-adjusted control arm ( placebo plus bevacizumab plus paclitaxel ) - corrected values ( QTcF ) .
METHODS	Categorical ECG findings were noted .
METHODS	Linear mixed effects modeling evaluated a potential concentration-QTcF relationship .
RESULTS	Out of 185 enrolled patients , 165 patients had ECG-evaluable data for analyses .
RESULTS	Similar QTcF and QTcF values were observed across all treatment arms , with mean increase < 10 and < 7 ms , respectively , across all time points .
RESULTS	Similar changes in heart rate , PR interval , and QRS duration were noted across all treatment arms .
RESULTS	Incidences of abnormal ECG findings of clinical interest were comparable in the onartuzumab-containing arms and the control arm .
RESULTS	No concentration-QTcF relationship was evident at onartuzumab serum concentrations up to 1,200 g/ml .
CONCLUSIONS	These data suggest that onartuzumab , at the dose and exposures studied in this clinical trial , does not meaningfully affect the QTcF interval .

###24232449
OBJECTIVE	Patients with acute ischemic stroke benefit from rapid evaluation and treatment , and timely brain imaging is a necessary component .
OBJECTIVE	We determined the effect of a targeted behavioral intervention on door-to-imaging time ( DIT ) among patients with ischemic stroke treated with tissue-type plasminogen activator .
OBJECTIVE	Second , we examined the variation in DIT accounted for by patient-level and hospital-level factors .
METHODS	The Increasing Stroke Treatment through Interventional behavioral Change Tactics ( INSTINCT ) trial was a cluster-randomized , controlled trial involving 24 Michigan hospitals .
METHODS	The intervention aimed to increase tissue-type plasminogen activator utilization .
METHODS	Detailed chart abstractions collected data for 557 patients with ischemic stroke .
METHODS	We used a series of hierarchical linear mixed-effects models to evaluate the effect of the intervention on DIT ( difference-in-differences analysis ) and used patient-level and hospital-level explanatory variables to decompose variation in DIT .
RESULTS	DIT improved over time , without a difference between intervention and control hospitals ( intervention : 23.7-19 .3 minutes , control : 28.9-19 .2 minutes ; P = 0.56 ) .
RESULTS	Adjusted DIT was faster in patients who arrived by ambulance ( 7.2 minutes ; 95 % confidence interval , 4.1-10 .2 ) , had severe strokes ( 1.0 minute per +5 - point National Institutes of Health Stroke Scale ; 95 % confidence interval , 0.1-2 .0 ) , and presented in the postintervention period ( 4.9 minutes ; 95 % confidence interval , 2.3-7 .4 ) .
RESULTS	After accounting for these factors , 13.8 % of variation in DIT was attributable to hospital .
RESULTS	Neither hospital stroke volume nor stroke center status was associated with DIT .
CONCLUSIONS	Performance on DIT improved similarly in intervention and control hospitals , suggesting that nonintervention factors explain the improvement .
CONCLUSIONS	Hospital-level factors explain a modest proportion of variation in DIT , but further research is needed to identify the hospital-level factors responsible .

###25219993
BACKGROUND	Establishing or providing occlusion that successfully permits efficient masticatory function is basic to dentistry .
BACKGROUND	To maintain harmony of the occlusal condition , the posterior teeth must pass close to but not contact their opposing teeth during mandibular movement .
BACKGROUND	Anterior guidance is essential to a harmonious functional relationship in the masticatory system .
OBJECTIVE	The objective of this study was to find out the frequency of pattern of occlusal contacts in lateral position and to compare the accuracy of shim-stock and articulating paper .
METHODS	This study was conducted in the Department of Prosthodontics , Kathmandu University School of Medical Sciences .
METHODS	The study consisted of 80 healthy subjects between the age group of 18-30 years .
METHODS	They were selected randomly from undergraduate students and dental hygienist of college of dental science and written consent was taken .
METHODS	This age was selected because of minimal occlusal wear .
RESULTS	In the present study with 80 participants the majority of the contact patterns with shimstock on the working side were group function ( 84 % ) , the canine protected occlusal patterns were found to be 12 % and the unclassifiable pattern were found to be 4 % .
RESULTS	On the otherhand , the data with articulating paper were group function type ( 94 % ) , the canine protected occlusal patterns as 2.5 % and the unclassifiable pattern were found to be 3.5 % .
RESULTS	In this study , with shim stock , the majority of the contact patterns were group function being 84 % whereas with the articulating paper it was 94 % .
RESULTS	When shim stock occlusal strip ( 12 m thick ) was compared to commonly used articulating paper ( 40 m ) , the excessive thickness of articulating paper that exceed the maximum recommended thickness of occlusal recording strips markedly must have given much more false contacts .
CONCLUSIONS	It was concluded that the majority of the contact pattern were group function being 84 % with shim stock and 94 % with articulating paper .
CONCLUSIONS	Also shim stock exhibits superior accuracy and reliability .

###25015650
BACKGROUND	Several pilot studies have evoked interest in robot-assisted therapy ( RAT ) in children with cerebral palsy ( CP ) .
OBJECTIVE	To assess the effectiveness of RAT in children with CP through a single-blind randomized controlled trial .
METHODS	Sixteen children with CP were randomized into 2 groups .
METHODS	Eight children performed 5 conventional therapy sessions per week over 8 weeks ( control group ) .
METHODS	Eight children completed 3 conventional therapy sessions and 2 robot-assisted sessions per week over 8 weeks ( robotic group ) .
METHODS	For both groups , each therapy session lasted 45 minutes .
METHODS	Throughout each RAT session , the patient attempted to reach several targets consecutively with the REAPlan .
METHODS	The REAPlan is a distal effector robot that allows for displacements of the upper limb in the horizontal plane .
METHODS	A blinded assessment was performed before and after the intervention with respect to the International Classification of Functioning framework : body structure and function ( upper limb kinematics , Box and Block test , Quality of Upper Extremity Skills Test , strength , and spasticity ) , activities ( Abilhand-Kids , Pediatric Evaluation of Disability Inventory ) , and participation ( Life Habits ) .
RESULTS	During each RAT session , patients performed 744 movements on average with the REAPlan .
RESULTS	Among the variables assessed , the smoothness of movement ( P < .01 ) and manual dexterity assessed by the Box and Block test ( P = .04 ) improved significantly more in the robotic group than in the control group .
CONCLUSIONS	This single-blind randomized controlled trial provides the first evidence that RAT is effective in children with CP .
CONCLUSIONS	Future studies should investigate the long-term effects of this therapy .

###24901900
BACKGROUND	Youth mental health is a significant public health concern due to the high prevalence of mental health problems in this population and the low rate of those affected seeking help .
BACKGROUND	While it is increasingly recognized that prevention is better than cure , most youth prevention programs have utilized interventions based on clinical treatments ( eg , cognitive behavioral therapy ) with inconsistent results .
OBJECTIVE	This study explores the feasibility of the online delivery of a youth positive psychology program , Bite Back , to improve the well-being and mental health outcomes of Australian youth .
OBJECTIVE	Further aims were to examine rates of adherence and attrition , and to investigate the program 's acceptability .
METHODS	Participants ( N = 235 ) aged 12-18 years were randomly assigned to either of two conditions : Bite Back ( n = 120 ) or control websites ( n = 115 ) .
METHODS	The Bite Back website comprised interactive exercises and information across a variety of positive psychology domains ; the control condition was assigned to neutral entertainment-based websites that contained no psychology information .
METHODS	Participants in both groups were instructed to use their allocated website for 6 consecutive weeks .
METHODS	Participants were assessed pre - and postintervention on the Depression Anxiety Stress Scale-Short form ( DASS-21 ) and the Short Warwick-Edinburgh Mental Well-Being Scale ( SWEMWBS ) .
RESULTS	Of the 235 randomized participants , 154 ( 65.5 % ) completed baseline and post measures after 6 weeks .
RESULTS	Completers and dropouts were equivalent in demographics , the SWEMWBS , and the depression and anxiety subscales of the DASS-21 , but dropouts reported significantly higher levels of stress than completers .
RESULTS	There were no differences between the Bite Back and control conditions at baseline on demographic variables , DASS-21 , or SWEMWBS scores .
RESULTS	Qualitative data indicated that 49 of 61 Bite Back users ( 79 % ) reported positive experiences using the website and 55 ( 89 % ) agreed they would continue to use it after study completion .
RESULTS	Compared to the control condition , participants in the Bite Back condition with high levels of adherence ( usage of the website for 30 minutes or more per week ) reported significant decreases in depression and stress and improvements in well-being .
RESULTS	Bite Back users who visited the site more frequently ( 3 times per week ) reported significant decreases in depression and anxiety and improvements in well-being .
RESULTS	No significant improvements were found among Bite Back users who demonstrated low levels of adherence or who used the website less frequently .
CONCLUSIONS	Results suggest that using an online positive psychology program can decrease symptoms of psychopathology and increase well-being in young people , especially for those who use the website for 30 minutes or longer per week or more frequently ( 3 times per week ) .
CONCLUSIONS	Acceptability of the Bite Back website was high .
CONCLUSIONS	These findings are encouraging and suggest that the online delivery of positive psychology programs may be an alternate way to address mental health issues and improve youth well-being nationally .
BACKGROUND	Australian New Zealand Clinical Trials Registry : ACTRN1261200057831 ; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=362489 ( Archived by Webcite at http://www.webcitation.org/6NXmjwfAy ) .

###25069759
OBJECTIVE	This open-label , prospective , observational study aimed to evaluate treatment response , efficacy therapy and safety to IFN -2 b for the essential thrombocythemia ( ET ) and polycythemia vera ( PV ) with JAK2V617F positive mutation .
METHODS	A total of 123 ET patients received IFN-2b therapy with JAK2V617F positive or negative mutation ; and 136 PV patients with JAK2V617F ( + ) received IFN-2b or hydroxyurea ( HU ) therapy according to random number assignment ( ages 18-65 years old ) .
RESULTS	ET patients receiving IFN -2 b with JAK2V617F ( + ) had a greater advantage in overall hematologic response ( OHR ) than JAK2V617F ( - ) ( 83.3 % versus 61.4 % , P < 0.01 ) .
RESULTS	For PV patients with JAK2V617F ( + ) , IFN had no OHR superiority to HU ( 70.3 % versus 70.8 % , P > 0.05 ) , but which gained a greater satisfactory molecular response than HU ( 54.7 % versus 19.4 % , P < 0.01 ) .
RESULTS	IFN significantly decreased the phlebotomy rate , which was better than HU for MPDs patients with OHR than HU ( 3.6 % versus 65.7 % , P < 0.01 ) .
RESULTS	Furthermore , ET patients with JAK2V617F ( + ) demonstrated a definite advantage over JAK2V617F ( - ) in five-year PFS ( 75.9 % versus 47.6 % , P < 0.05 ) .
RESULTS	For PV patients with JAK2V617F ( + ) , IFN -2 b was superior to HU in five-year PFS ( 66.3 % versus 46.7 % , P < 0.01 ) .
RESULTS	Moreover , IFN -2 b also contributed to improved vasomotor symptoms in MPDs , and especially significantly decreased the incidence of distal paresthesias ( 14.1 % versus 37.5 % ) and erythromelalgia ( 9.4 % versus 29.2 % ) better than HU ( P < 0.01 ) .
RESULTS	Meanwhile , IFN did not observe the severe hematological adverse events in patients with PV or ET .
CONCLUSIONS	The data confirmed that IFN -2 b benefited the patients with ET or PV , particularly for JAK2V617F ( + ) mutation .

###24332218
BACKGROUND	The inflammatory response in patients with seasonal allergic rhinitis ( SAR ) is partly mediated by the prostaglandin D2 receptor chemoattractant receptor homologous molecule on T ( H ) 2 cells ( CRTH2 ) .
OBJECTIVE	We sought to investigate the efficacy and safety of the oral CRTH2 antagonist BI 671800 ( 50 , 200 , and 400 mg twice daily ) , fluticasone propionate nasal spray ( 200 g once daily ) , or oral montelukast ( 10 mg once daily ) administered for 2 weeks in patients with SAR .
METHODS	In this randomized , double-blind , placebo-controlled , partial-crossover study , participants aged 18 to 65 years with a positive skin prick test to Dactylis glomerata pollen were exposed to out-of-season allergen in the environmental challenge chamber for 6 hours .
METHODS	The primary efficacy variable was the total nasal symptom score assessed as the area under the curve ( AUC ) ( 0-6h ) .
RESULTS	In total , 146 patients ( 63.7 % male ; mean age , 36.1 years ) were randomized .
RESULTS	The adjusted mean total nasal symptom score AUC ( 0-6h ) was significantly reduced versus placebo with 200 mg of BI 671800 ( absolute difference , -0.85 ; percentage difference , -17 % ; P = .0026 ) , montelukast ( absolute difference , -0.74 ; percentage difference , -15 % ; P = .0115 ) , and fluticasone propionate ( absolute difference , -1.64 ; percentage difference , -33 % ; P < .0001 ) .
RESULTS	Compared with placebo , BI 671800 significantly reduced nasal eosinophil values ( P < .05 for all doses ) , significantly inhibited nasal inflammatory cytokine levels ( IL-4 and eotaxin , P < .05 ; 200 mg twice daily ) , and induced a dose-related reduction in ex vivo prostaglandin D2-mediated eosinophil shape change .
CONCLUSIONS	Two hundred milligrams of BI 671800 twice daily demonstrated efficacy in treating SAR symptoms induced by environmental challenge chamber allergen exposure and had a favorable safety profile .

###24339313
OBJECTIVE	The effects of an oral hygienic care program ( OHCP ) have been reported in several diseases .
OBJECTIVE	However , no study exists investigating the influence of an OHCP on stroke patients or patients in the intensive care unit ( ICU ) has been reported , thus we sought to investigate the potential effect of an OHCP .
METHODS	Fifty-six consecutive stroke patients who were admitted to the ICU were randomly assigned to two groups : the intervention ( 29 patients ) and control groups ( 27 patients ) .
METHODS	The OHCP included tooth brushing with an inter-dental brush and tongue cleaner and cleaning with chlorhexidine was administered to patients by one dentist once per day during admission in the ICU ( mean , 2.2 weeks ) .
METHODS	The plague index , gingival index , clinical attachment loss , and colonization degree of candida albicans were assessed .
RESULTS	After OHCP , the plaque index , gingival index , and colonization degree of candida albicans in saliva showed a significant decrease in the intervention group compared to those of the control group ( p < 0.05 ) .
RESULTS	However , no significant difference was observed in clinical attachment loss and the colonization degree of candida albicans on the tongue ( p > 0.05 ) .
CONCLUSIONS	Our OHCP was effective in improving the oral hygienic status and periodontal health of stroke patients during their stay in the ICU .
CONCLUSIONS	Therefore , we recommend administration of the OHCP for stroke patients during their stay in the ICU .

###25868634
BACKGROUND	There are limited data on the performance of narrow band imaging ( NBI ) and Fujinon intelligent color enhancement ( FICE ) for differentiating polyp histologies .
OBJECTIVE	The aim of this study was to compare the diagnostic performances of NBI and FICE in differentiating neoplastic from non-neoplastic colorectal polyps < 10 mm during screening colonoscopy .
METHODS	A total of 955 average-risk adults undergoing screening colonoscopies were randomly allocated to NBI or FICE groups .
METHODS	Four board-certified staff endoscopists without prior experience using NBI or FICE participated .
METHODS	The main outcomes of this study were overall accuracy , sensitivity , and specificity of FICE and NBI in identifying neoplastic polyps .
RESULTS	There was no significant difference in the number of subjects with adenoma between the NBI ( 143/475 , 30.1 % ) and FICE groups ( 139/480 , 29.0 % ) ( after excluding adenoma 1 cm ) ( P > 0.05 ) .
RESULTS	The overall accuracy of NBI was 81.0 % , compared with 81.4 % for FICE ( P = 0.867 ) .
RESULTS	The overall sensitivity and specificity of NBI and FICE were 84.6 and 78.0 % ( P = 0.054 ) ; 75.1 and 86.5 % ( P = 0.009 ) , respectively .
RESULTS	For polyps measuring 5 mm , the accuracy was 79.4 % for NBI and 80.1 % for FICE ( P = 0.835 ; sensitivity 81.9 vs. 74.5 % , P = 0.064 ; specificity 75.7 vs. 88.4 % , P = 0.006 ) .
CONCLUSIONS	The overall accuracy of NBI and FICE was similar for differentiating small polyp histologies during screening colonoscopy .
CONCLUSIONS	However , better results should be achieved before using NBI or FICE as real-time optical biopsy of colorectal polyps in screening colonoscopy .

###24221391
BACKGROUND	The Placement of Aortic Transcatheter Valves ( PARTNER ) trial demonstrated similar survival after transcatheter and surgical aortic valve replacement ( TAVR and SAVR , respectively ) in high-risk patients with symptomatic , severe aortic stenosis .
BACKGROUND	The aim of this study was to evaluate the effect of left ventricular ( LV ) dysfunction on clinical outcomes after TAVR and SAVR and the impact of aortic valve replacement technique on LV function .
RESULTS	The PARTNER trial randomized high-risk patients with severe aortic stenosis to TAVR or SAVR .
RESULTS	Patients were stratified by the presence of LV ejection fraction ( LVEF ) < 50 % .
RESULTS	All-cause mortality was similar for TAVR and SAVR at 30-days and 1 year regardless of baseline LV function and valve replacement technique .
RESULTS	In patients with LV dysfunction , mean LVEF increased from 35.78.5 % to 48.611.3 % ( P < 0.0001 ) 1 year after TAVR and from 38.08.0 % to 50.110.8 % after SAVR ( P < 0.0001 ) .
RESULTS	Higher baseline LVEF ( odds ratio , 0.90 [ 95 % confidence interval , 0.86 , 0.95 ] ; P < 0.0001 ) and previous permanent pacemaker ( odds ratio , 0.34 [ 95 % confidence interval , 0.15 , 0.81 ] ) were independently associated with reduced likelihood of 10 % absolute LVEF improvement by 30 days ; higher mean aortic valve gradient was associated with increased odds of LVEF improvement ( odds ratio , 1.04 per 1 mm Hg [ 95 % confidence interval , 1.01 , 1.08 ] ) .
RESULTS	Failure to improve LVEF by 30 days was associated with adverse 1-year outcomes after TAVR but not SAVR .
CONCLUSIONS	In high-risk patients with severe aortic stenosis and LV dysfunction , mortality rates and LV functional recovery were comparable between valve replacement techniques .
CONCLUSIONS	TAVR is a feasible alternative for patients with symptomatic severe aortic stenosis and LV dysfunction who are at high risk for SAVR .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00530894 .

###24372443
OBJECTIVE	To investigate the effects of nursing care based on the Theory of Human Caring on distress caused by infertility , perceived self-efficacy and adjustment levels .
BACKGROUND	Infertility leads to individual , familial and social problems .
BACKGROUND	Nursing care standards for women affected by infertility have yet to emerge .
METHODS	A randomized controlled trial .
METHODS	This study was conducted from May 2010-February 2011 , with 105 Turkish women with infertility ( intervention group : 52 , control group : 53 ) .
METHODS	We collected data using the Infertility Distress Scale , the Turkish-Infertility Self Efficacy Scale Short Form and the Turkish-Fertility Adjustment Scale .
METHODS	The intervention group received nursing care based on the Theory of Human Caring .
METHODS	Data were analysed using t-tests , chi-square tests and intention-to-treat analyses .
RESULTS	The intervention and control groups significantly differed with regard to infertility distress , self-efficacy and adjustment levels .
RESULTS	The intervention group 's mean self-efficacy score increased by seven points and adjustment score decreased by seven points ( in a positive direction ) .
RESULTS	In addition , there was a significant reduction in infertility distress scores in the intervention group , but there was no change in the control group .
CONCLUSIONS	Nursing care based on the Theory of Human Caring decreased the negative impact of infertility in women receiving infertility treatment and increased self-efficacy and adjustment .

###24815889
BACKGROUND	Allergic rhinitis ( AR ) affects up to 30 % of the adult population and symptomatic patients continue to engage in daily life activities , including car driving .
BACKGROUND	Previous studies have shown that AR can impair cognitive functions , especially during longer-lasting tasks .
BACKGROUND	Other reports suggest negative effects on psychomotor functions such as driving , but no clear evidence has been presented yet .
OBJECTIVE	Primary objective was to determine the effect of AR per se on actual driving performance and compare it with the effects of treated AR .
METHODS	Nineteen patients with documented AR history underwent a unique and validated 1-h on-the-road driving test outside the pollen season .
METHODS	In a 4-leg repeated measures design , patients underwent a nasal provocation test with either pollen or inactive control prior to the driving test .
METHODS	In the three conditions with pollen provocation , patients were pretreated with either cetirizine 10mg , fluticasone furoate 27.5 g , or placebo to alleviate the provoked AR symptoms .
RESULTS	The driving performance of patients when symptomatic and not treated was significantly impaired compared to the placebo condition .
RESULTS	When engaging in a secondary memory task during driving , their performance deteriorated further .
RESULTS	The magnitude of impairment was relevant and comparable to that seen at a blood alcohol level of 0.05 % , the legal limit in many countries .
RESULTS	Treatment of AR symptoms partially counteracted the effect of AR on driving .
CONCLUSIONS	Untreated AR can impair driving ability and put patients at risk .
CONCLUSIONS	Drug therapy reduces this impairment , and AR patients should therefore be advised to always treat their condition .

###25929840
BACKGROUND	Depression is common in primary care and is often unrecognized and untreated .
BACKGROUND	Studies are needed to demonstrate the feasibility of implementing evidence-based depression care provided by primary health care workers ( PHCWs ) in sub-Saharan Africa .
BACKGROUND	We carried out a pilot two-parallel arm cluster randomized controlled trial of a package of care for depression in primary care .
METHODS	Six primary health care centers ( PHCC ) in two Local Government Areas of Oyo State , South West Nigeria were randomized into 3 intervention and 3 control clinics .
METHODS	Three PHCWs were selected for training from each of the participating clinics .
METHODS	The PHCWs from the intervention clinics were trained to deliver a manualized multicomponent stepped care intervention package for depression consisting of psychoeducation , activity scheduling , problem solving treatment and medication for severe depression .
METHODS	Providers from the control clinics delivered care as usual , enhanced by a refresher training on depression diagnosis and management .
METHODS	Outcome measures Patient 's Health Questionnaire ( PHQ-9 ) , WHO quality of Life instrument ( WHOQOL-Bref ) and the WHO disability assessment schedule ( WHODAS ) were administered in the participants ' home at baseline , 3 and 6months .
RESULTS	About 98 % of the consecutive attendees to the clinics agreed to have the screening interview .
RESULTS	Of those screened , 284 ( 22.7 % ) were positive ( PHQ-9 score8 ) and 234 gave consent for inclusion in the study : 165 from intervention and 69 from control clinics .
RESULTS	The rates of eligible and consenting participants were similar in the control and intervention arms .
RESULTS	In all 85.9 % ( 92.8 % in intervention and 83 % in control ) of the participants were successfully administered outcome assessments at 6months .
RESULTS	The PHCWs had little difficulty in delivering the intervention package .
RESULTS	At 6months follow up , depression symptoms had improved in 73.0 % from the intervention arm compared to 51.6 % control .
RESULTS	Compared to the mean scores at baseline , there was improvement in the mean scores on all outcome measures in both arms at six months .
CONCLUSIONS	The results provide support for the feasibility of conducting a fully-powered randomized study in this setting and suggest that the instruments used may have the potential to detect differences between the arms .
BACKGROUND	ISRCTN46754188 ( ISRTCN registry at isrtcn.com ) ; registered 23 September 2013 , details of the pilot study added 12/02/2015 .

###24397441
OBJECTIVE	To compare the effectiveness and safety of two cervical ripening methods in term primiparous women with unfavorable cervices and oligohydramnios .
METHODS	Women ( 126 cases ) with oligohydramnios [ amniotic fluid index ( AFI ) 5cm ] and a low Bishop Score ( 6 ) were assigned randomly to use double balloon catheter ( mechanical method group , 67 cases ) or dinoprostone 10mg controlled-release vaginal insert ( pharmacological method group , 59 cases ) for induction of labor .
METHODS	The study 's primary outcome was caesarean section rate ( CSR ) .
METHODS	The secondary outcome measures included maternal and neonatal morbidity , an incremental changes in Bishop Score , and intrapartum interventions .
RESULTS	There was no significant difference between the mechanical method group and the pharmacological method group in CSR and change in Bishop Score .
RESULTS	Tacysystole , non-reassuring fetal heart patterns , and cases of newborn umbilical-cord arterial blood pH < 7.1 were significantly lower with the mechanical method compared with the pharmacological method ( p < 0.05 ) .
RESULTS	More patients needed additional intervention in the mechanical method group .
CONCLUSIONS	Both methods resulted in a similar CSR .
CONCLUSIONS	Double balloon catheter resulted in fewer labor complications , but more frequent use of oxytocin and amniotomy .
CONCLUSIONS	Compared with dinoprostone vaginal insert , double balloon catheter use may be less problematic in women with oligohydramnios .

###24402391
OBJECTIVE	To determine if sarcopenia modulates the response to a physical activity intervention in functionally limited older adults .
METHODS	Secondary analysis of a randomized controlled trial .
METHODS	Three academic centers .
METHODS	Elders aged 70 to 89 years at risk for mobility disability who underwent dual-energy x-ray absorptiometry ( DXA ) for body composition at enrollment and follow-up at twelve months ( N = 177 ) .
METHODS	Subjects participated in a physical activity program ( PA ) featuring aerobic , strength , balance , and flexibility training , or a successful aging ( SA ) educational program about healthy aging .
METHODS	Sarcopenia as determined by measuring appendicular lean mass and adjusting for height and total body fat mass ( residuals method ) , Short Physical Performance Battery score ( SPPB ) , and gait speed determined on 400 meter course .
RESULTS	At twelve months , sarcopenic and non-sarcopenic subjects in PA tended to have higher mean SPPB scores ( 8.70.5 and 8.70.2 points ) compared to sarcopenic and non-sarcopenic subjects in SA ( 8.30.5 and 8.40.2 points , p = 0.24 and 0.10 ) , although the differences were not statistically significant .
RESULTS	At twelve months , faster mean gait speeds were observed in PA : 0.930.4 and 0.950.03 meters/second in sarcopenic and non-sarcopenic PA subjects , and 0.890.4 and 0.910.03 meters/second in sarcopenic and non-sarcopenic SA subjects ( p = 0.98 and 0.26 ) , although not statistically significant .
RESULTS	There was no difference between the sarcopenic and non-sarcopenic groups in intervention adherence or number of adverse events .
CONCLUSIONS	These data suggest that older adults with sarcopenia , who represent a vulnerable segment of the elder population , are capable of improvements in physical performance after a physical activity intervention .

###25592412
BACKGROUND	Selegiline ( l-deprenyl ) is a selective monoamine oxidase type B inhibitor that has been shown to have neurotrophic and anti-apoptotic properties and to protect neurons in different experimental models of cerebral ischaemia .
BACKGROUND	The aim of this explorative study was to investigate whether selegiline could enhance cognitive and functional recovery in stroke survivors .
METHODS	This was a randomized controlled study in which patients enrolled within two weeks of stroke underwent a clinical and functional evaluation and a neuropsychological assessment .
METHODS	The patients were given selegiline ( 10mg/day ) or matched placebo once a day for six weeks in addition to standard rehabilitation care .
RESULTS	Of 137 stroke survivors , 47 patients met the inclusion criteria and were randomly assigned to the Study Group ( n = 23 ) or the Control Group ( n = 24 ) .
RESULTS	The statistical analysis showed a significant improvement in most neuropsychological tests after two and six weeks in the study group ; these improvements were not replicated in the control group .
RESULTS	The between-group analysis revealed that the domains of attention and executive functions benefited most from the drug treatment .
RESULTS	With regard to functional status , comparison of clinical scores at admission and discharge showed a statistically significant enhancement in both groups without statistically significant differences between the groups .
CONCLUSIONS	These preliminary results suggest that selegiline administered in the subacute phase can promote cognitive functioning in stroke patients .
CONCLUSIONS	Further studies will elucidate whether and how this enhancement can impact on functional recovery in the short and in the long term .

###24759327
OBJECTIVE	Covalent immobilization of antimicrobial peptide melimine onto contact lenses can produce broad-spectrum antimicrobial lenses .
OBJECTIVE	The purpose of this study was to investigate the performance of melimine-coated contact lenses in an animal model and human clinical trial .
METHODS	Melimine was covalently attached onto the surface of contact lenses via EDC ( 1-ethyl-3 - [ 3-dimethylaminopropyl ] carbodiimide hydrochloride ) coupling .
METHODS	A rabbit model of daily contralateral wear of lenses for 22 days was conducted to assess the lens safety .
METHODS	A prospective , randomized , double-masked , one-day human clinical trial was used to evaluate subjective responses and ocular physiology during contralateral wear of melimine-coated ( test ) and uncoated ( control ) lenses .
METHODS	Delayed reactions were monitored during follow-up visits after 1 and 4 weeks .
METHODS	Ex vivo retention of antimicrobial activity of worn lenses was assessed by reduction in numbers of viable Pseudomonas aeruginosa and Staphylococcus aureus .
RESULTS	Melimine-coated lenses produced no ocular signs or symptoms that would indicate cytotoxicity during the lens wear of rabbits .
RESULTS	No histological changes were found in rabbit corneas .
RESULTS	During the human trial , no differences were observed in wettability , surface deposition , lens-fitting centration , movement , tightness , and corneal coverage between test and control lenses ( p > 0.05 ) .
RESULTS	There were no significant differences in bulbar , limbal , or palpebral redness or conjunctival staining ( p > 0.05 ) .
RESULTS	Mean corneal ( extent , depth , and type ) staining was higher for test lenses compared with that for control lenses ( p < 0.05 ) .
RESULTS	There was no significant difference in subjective responses for lens comfort , dryness , and awareness ( p > 0.05 ) .
RESULTS	No delayed reactions were associated with the test lenses .
RESULTS	Worn test lenses retained more than 1.5 log inhibition against both bacterial types .
CONCLUSIONS	Melimine-coated contact lenses were worn safely by humans .
CONCLUSIONS	However , they were associated with higher corneal staining .
CONCLUSIONS	The melimine-coated lenses retained high antibacterial activity after wear .

###24258468
OBJECTIVE	Postoperative sore throat ( POST ) is a frequent complication caused by mucosal trauma to the pharyngeal , laryngeal , and tracheal airway after endotracheal intubation .
OBJECTIVE	We compared the effectiveness of Siccoral , Strefen , and Stomatovis treatments in alleviating POST .
METHODS	This prospective , randomized , single-blinded , controlled trial compares the incidence of POST with Strefen lozenges , Siccoral spray , or Stomatovis gargle .
METHODS	Three hundred and twenty American Society of Anesthesiologists class I-III patients undergoing elective genitourinary surgery under general orotracheal anesthesia were randomly allocated to four groups of 80 patients each .
METHODS	In the postoperative awakening unit and during related services , POST was evaluated by a blinded anesthesiologist at 0 , 1 , 6 , and 24 h post extubation .
RESULTS	The highest incidence of POST occured at 0 and 1 h post extubation in all groups ( P = 0.002 10 ( -7 ) , P = 0.004 10 ( -6 ) , respectively ) .
RESULTS	A significantly lower incidence of POST was observed in Strefen and Siccoral groups at 0 and 1 h compared to Control group ( Strefen : P = 0.004 10 ( -2 ) , P = 0.007 10 ( -4 ) ; Siccoral : P = 0.003 10 ( -8 ) , P = 0.007 10 ( -5 ) , respectively ) .
RESULTS	A significantly lower incidence of POST was observed with Siccoral treatment at 0 h post extubation ( P = 0.002 vs. Strefen treatment ) .
RESULTS	Although POST incidence was not significantly different between the Stomatovis and Control groups , it was lower in the Stomatovis group at 0 and 1 h ( P = 0.026 and 0.013 , respectively ) .
RESULTS	The incidence of POST was similar in all groups at 6 and 24 h post extubation ( P = 0.141 and 0.426 , respectively ) .
CONCLUSIONS	Siccoral and Strefen can be effective in relieving POST in the early hours after extubation .

###24907875
BACKGROUND	Etomidate causes pain when injected intravenously .
BACKGROUND	In this study we sought to determine if pretreatment by ondansetron reduces the pain on injection of etomidate .
METHODS	In this randomized , double blinded , placebo-controlled clinical trial , 20 patients of both sexes aged between 18 and 50 years of American Society of Anesthesiologists ( ASA ) physical status class I or II , whom were candidates for various elective surgical procedures and need more than one intravenous access were enrolled in the study .
METHODS	On arrival to the operating room two 22 gauge cannulas were inserted into veins on the dorsum of both hands .
METHODS	Following the infusion of 100mL normal saline into both intravenous lines , using an elastic band , venous drainage of hands was occluded at midarm .
METHODS	The patients were administered 8 mg ( 2 mL ) of ondansetron into one hand and 2 mL of 0.9 % saline into the other hand at the same time .
METHODS	The elastic band was removed after 1 min and 2mg ( 1 mL ) of etomidate was administered at the same rate simultaneously into intravenous lines .
METHODS	The patients were asked to give a score of pain based on a verbal analog scale ( VAS ) to each hand .
RESULTS	A total number of 20 patients were studied ( male = 55 % , female = 45 % ) .
RESULTS	The mean age of the participants was 37.5 13.1 years old and the mean weight was 67.7 7.3 kg .
RESULTS	The mean VAS for injection pain of etomidate after pre-administration of intravenous ondansetron was 1.5 1.2 which was lower compared to pre-administration of placebo ( 3.2 2.8 , p < 0.05 ) .
CONCLUSIONS	This study illustrates that pre-treatment with intravenous ondansetron significantly reduces the pain on injection of etomidate .

###24656538
OBJECTIVE	This study sought to determine pharmacodynamic effects during transition from intravenous cangrelor to oral ticagrelor and from oral ticagrelor to intravenous cangrelor .
BACKGROUND	Cangrelor is an intravenous antagonist of P2Y12 and its use will require transition to and from oral agents .
METHODS	Patients ( n = 12 ) with stable coronary artery disease who were taking aspirin 81 mg daily were recruited .
METHODS	On study day 1 , they received a bolus plus 2-h infusion of cangrelor plus a 180-mg dose of ticagrelor at either 0.5 h ( n = 6 ) or 1.25 h ( n = 6 ) .
METHODS	Pharmacodynamic effects ( light transmission platelet aggregation in response to 20 and 5 mol/l adenosine diphosphate , VerifyNow , P2Y12 assay ( Accumetrics , San Diego , California ) , vasodilator-stimulated phosphoprotein index , and flow cytometry ) were assessed during and after the cangrelor infusion .
METHODS	Patients took 90 mg of ticagrelor twice daily for either 6 ( n = 6 ) or 7 ( n = 6 ) doses .
METHODS	On study day 5 , pharmacodynamic effects were assessed before and during a bolus plus 2-h infusion of cangrelor .
RESULTS	During cangrelor infusion , extensive inhibition of platelet function reflected by limited residual platelet reactivity was apparent .
RESULTS	After cangrelor was stopped , the antiplatelet effects of ticagrelor were preserved despite a modest increase in platelet reactivity .
CONCLUSIONS	Ticagrelor given before or during infusion of cangrelor did not attenuate the pharmacodynamic effects of cangrelor .
CONCLUSIONS	The pharmacodynamic effects of ticagrelor were preserved when ticagrelor was given during infusion of cangrelor .
CONCLUSIONS	Consistent with the reversible binding of ticagrelor , this oral P2Y12 antagonist can be administered before , during , or after treatment with cangrelor .

###24505285
BACKGROUND	Several studies conducted in Northeast Tanzania have documented declines in malaria transmission even before interventions were scaled up .
BACKGROUND	One explanation for these reductions may be the changes in socio-environmental conditions associated with economic development , and in particular improvements in housing construction .
OBJECTIVE	This analysis seeks to identify ( 1 ) risk factors for malaria incidence among young children and ( 2 ) household and environmental factors associated with mosquito vector numbers collected in the child 's sleeping area .
OBJECTIVE	Both analyses focus on housing construction quality as a key determinant .
METHODS	For 435 children enrolled in a larger trial of intermittent preventive treatment for malaria in infants in the Korogwe District in Tanga , Northeastern Tanzania , detailed information on their dwelling characteristics were collected in the last year of the trial .
METHODS	Principal components analysis was used to construct an index of housing structure quality and converted to quintile units for regression analysis .
METHODS	Univariate and multivariate random effects negative binomial regressions were used to predict risk factors for child malaria incidence and the mean total number of indoor female Anopheles gambiae and funestus mosquitoes collected per household across three occasions .
RESULTS	Building materials have substantially improved in Korogwe over time .
RESULTS	Multivariate regressions showed that residing in rural areas ( versus urban ) increased malaria incidence rates by over three-fold and mean indoor female A. gambiae and funestus numbers by nearly two-fold .
RESULTS	Compared to those residing in the lowest quality houses , children residing in the highest quality houses had one-third lower malaria incidence rates , even when wealth and rural residence were controlled for .
RESULTS	Living in the highest quality houses reduced vector numbers while having cattle near the house significantly increased them .
CONCLUSIONS	Results corroborate findings from other studies that show associations between malaria incidence and housing quality ; associations were concentrated amongst the highest quality houses .

###26284720
OBJECTIVE	Weight loss of 5 % to 10 % can improve type 2 diabetes and related comorbidities .
OBJECTIVE	Few safe , effective weight-management drugs are currently available .
OBJECTIVE	To investigate efficacy and safety of liraglutide vs placebo for weight management in adults with overweight or obesity and type 2 diabetes .
METHODS	Fifty-six-week randomized ( 2:1:1 ) , double-blind , placebo-controlled , parallel-group trial with 12-week observational off-drug follow-up period .
METHODS	The study was conducted at 126 sites in 9 countries between June 2011 and January 2013 .
METHODS	Of 1361 participants assessed for eligibility , 846 were randomized .
METHODS	Inclusion criteria were body mass index of 27.0 or greater , age 18 years or older , taking 0 to 3 oral hypoglycemic agents ( metformin , thiazolidinedione , sulfonylurea ) with stable body weight , and glycated hemoglobin level 7.0 % to 10.0 % .
METHODS	Once-daily , subcutaneous liraglutide ( 3.0 mg ) ( n = 423 ) , liraglutide ( 1.8 mg ) ( n = 211 ) , or placebo ( n = 212 ) , all as adjunct to 500 kcal/d dietary deficit and increased physical activity ( 150 min/wk ) .
METHODS	Three coprimary end points : relative change in weight , proportion of participants losing 5 % or more , or more than 10 % , of baseline weight at week 56 .
RESULTS	Baseline weight was 105.7 kg with liraglutide ( 3.0-mg dose ) , 105.8 kg with liraglutide ( 1.8-mg dose ) , and 106.5 kg with placebo .
RESULTS	Weight loss was 6.0 % ( 6.4 kg ) with liraglutide ( 3.0-mg dose ) , 4.7 % ( 5.0 kg ) with liraglutide ( 1.8-mg dose ) , and 2.0 % ( 2.2 kg ) with placebo ( estimated difference for liraglutide [ 3.0 mg ] vs placebo , -4.00 % [ 95 % CI , -5.10 % to -2.90 % ] ; liraglutide [ 1.8 mg ] vs placebo , -2.71 % [ 95 % CI , -4.00 % to -1.42 % ] ; P < .001 for both ) .
RESULTS	Weight loss of 5 % or greater occurred in 54.3 % with liraglutide ( 3.0 mg ) and 40.4 % with liraglutide ( 1.8 mg ) vs 21.4 % with placebo ( estimated difference for liraglutide [ 3.0 mg ] vs placebo , 32.9 % [ 95 % CI , 24.6 % to 41.2 % ] ; for liraglutide [ 1.8 mg ] vs placebo , 19.0 % [ 95 % CI , 9.1 % to 28.8 % ] ; P < .001 for both ) .
RESULTS	Weight loss greater than 10 % occurred in 25.2 % with liraglutide ( 3.0 mg ) and 15.9 % with liraglutide ( 1.8 mg ) vs 6.7 % with placebo ( estimated difference for liraglutide [ 3.0 mg ] vs placebo , 18.5 % [ 95 % CI , 12.7 % to 24.4 % ] , P < .001 ; for liraglutide [ 1.8 mg ] vs placebo , 9.3 % [ 95 % CI , 2.7 % to 15.8 % ] , P = .006 ) .
RESULTS	More gastrointestinal disorders were reported with liraglutide ( 3.0 mg ) vs liraglutide ( 1.8 mg ) and placebo .
RESULTS	No pancreatitis was reported .
CONCLUSIONS	Among overweight and obese participants with type 2 diabetes , use of subcutaneous liraglutide ( 3.0 mg ) daily , compared with placebo , resulted in weight loss over 56 weeks .
CONCLUSIONS	Further studies are needed to evaluate longer-term efficacy and safety .
BACKGROUND	clinicaltrials.gov Identifier : NCT01272232 .

###25413378
OBJECTIVE	To investigate the association between consecutively measured thromboelastographic ( TEG ) tracings and outcome in patients with severe sepsis .
METHODS	Multicentre prospective observational study in a subgroup of the Scandinavian Starch for Severe Sepsis/Septic Shock ( 6S ) Trial ( NCT00962156 ) comparing hydroxyethyl starch ( HES ) 130/0 .42 vs. Ringer 's acetate for fluid resuscitation in severe sepsis .
METHODS	TEG ( standard and functional fibrinogen ) was measured consecutively for 5 days , and clinical data including bleeding and death was retrieved from the trial database .
METHODS	Statistical analyses included Cox regression with time-dependent covariates and joint modelling techniques .
RESULTS	Of 267 eligible patients , we analysed 260 patients with TEG data .
RESULTS	At 90 days , 68 ( 26 % ) had bled and 139 ( 53 % ) had died .
RESULTS	For all TEG variables , hypocoagulability according to the reference range was significantly associated with increased risk of death .
RESULTS	In a linear model , hazard ratios for death were 6.03 ( 95 % confidence interval , 1.64-22 .17 ) for increased clot formation speed , 1.10 ( 1.04-1 .16 ) for decreased angle , 1.09 ( 1.05-1 .14 ) for decreased clot strength and 1.12 ( 1.06-1 .18 ) for decreased fibrinogen contribution to clot strength ( functional fibrinogen MA ) , showing that deterioration towards hypocoagulability in any TEG variable significantly increased the risk of death .
RESULTS	Patients treated with HES had lower functional fibrinogen MA than those treated Ringer 's acetate , which significantly increased the risk of subsequent bleeding [ HR 2.43 ( 1.16-5 .07 ) ] and possibly explained the excess bleeding with HES in the 6S trial .
CONCLUSIONS	In our cohort of patients with severe sepsis , progressive hypocoagulability defined by TEG variables was associated with increased risk of death and increased risk of bleeding .

###24931956
OBJECTIVE	Knowledge about the effects of exercise in severe and endstage osteoarthritis ( OA ) is limited .
OBJECTIVE	The aim was to evaluate the efficacy of a neuromuscular exercise program in patients with clinically severe hip or knee OA .
METHODS	This was a randomized controlled assessor-blinded trial .
METHODS	Patients received an educational package ( care-as-usual ) only , or care-as-usual plus an 8-week neuromuscular exercise intervention ( NEMEX-TJR ) .
METHODS	NEMEX-TJR was supervised by a physiotherapist , twice weekly for 1 h.
METHODS	The primary outcome was Activities of Daily Living ( ADL ) subscale from the Hip disability and Osteoarthritis Outcome Score ( HOOS ) and the Knee Injury and Osteoarthritis Outcome Score ( KOOS ) questionnaire .
METHODS	The secondary outcomes were the HOOS/KOOS subscales Pain , Symptoms , Sport and Recreation , and Joint-related Quality of Life .
METHODS	Exploratory outcomes were functional performance measures and lower limb muscle power .
RESULTS	Included were 165 patients , 56 % female , average age 67 years ( SD 8 ) , and a body mass index of 30 ( SD 5 ) , who were scheduled for primary hip or knee replacement .
RESULTS	The postintervention difference between mean changes in ADL was 7.2 points ( 95 % CI 3.5 to 10.9 , p = 0.0002 ) in favor of NEMEX-TJR compared with control .
RESULTS	Second , there were statistically significant differences between groups in favor of NEMEX-TJR on all self-reported outcomes and most functional performance tests ( walk , chair stands , and 1-leg knee bends ) .
RESULTS	Stratified analyses according to joint revealed moderate effect size for ADL for hip patients ( 0.63 , 95 % CI 0.26 to 1.00 ) .
RESULTS	Corresponding effect size for knee patients was small ( 0.23 95 % CI -0.14 to 0.60 ) .
CONCLUSIONS	Feasibility of neuromuscular exercise was confirmed in patients about to have total joint replacement .
CONCLUSIONS	Self-reported activities of daily living and objective performance were improved and pain reduced immediately following 8 weeks of neuromuscular exercise .
CONCLUSIONS	While the effects were moderate in hip OA , they were only small in knee OA .
CONCLUSIONS	ClinicalTrials.gov Identifier : NCT01003756 .

###24360369
BACKGROUND	Clinical effectiveness of previous regimens to treat Plasmodium vivax infection have been hampered by compliance .
BACKGROUND	We aimed to assess the dose-response , safety , and tolerability of single-dose tafenoquine plus 3-day chloroquine for P vivax malaria radical cure .
METHODS	In this double-blind , randomised , dose-ranging phase 2b study , men and women ( aged 16 years ) with microscopically confirmed P vivax monoinfection ( parasite density > 100 to < 100,000 per L blood ) were enrolled from community health centres and hospitals across seven sites in Brazil , Peru , India , and Thailand .
METHODS	Patients with glucose-6-phosphate dehydrogenase enzyme activity of less than 70 % were excluded .
METHODS	Eligible patients received chloroquine ( days 1-3 ) and were randomly assigned ( 1:1:1:1:1:1 ) by a computer-generated randomisation schedule to receive single-dose tafenoquine 50 mg , 100 mg , 300 mg , or 600 mg , primaquine 15 mg for 14 days , or chloroquine alone .
METHODS	Randomisation was stratified by baseline parasite count ( 7500 and > 7500 per L blood ) .
METHODS	The primary efficacy endpoint was relapse-free efficacy at 6 months from initial dose ( ie , clearance of initial infection without subsequent microscopically confirmed infection ) , analysed by intention to treat .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01376167 .
RESULTS	Between Sept 19 , 2011 , and March 25 , 2013 , 329 patients were randomly assigned to a treatment group ( chloroquine plus tafenoquine 50 mg [ n = 55 ] , 100 mg [ n = 57 ] , 300 mg [ n = 57 ] , 600 mg [ n = 56 ] ; or to chloroquine plus primaquine [ n = 50 ] ; or chloroquine alone [ n = 54 ] ) .
RESULTS	Relapse-free efficacy at 6 months was 577 % ( 95 % CI 43-70 ) with tafenoquine 50 mg , 541 % ( 40-66 ) with tafenoquine 100 mg , 892 % ( 77-95 ) with tafenoquine 300 mg , 919 % ( 80-97 ) with tafenoquine 600 mg , 773 % ( 63-87 ) with primaquine , and 375 % ( 23-52 ) with chloroquine alone .
RESULTS	Tafenoquine 300 mg and 600 mg had better efficacy than chloroquine alone ( treatment differences 517 % [ 95 % CI 35-69 ] , p < 00001 , with tafenoquine 300 mg and 545 % [ 38-71 ] , p < 00001 , with tafenoquine 600 mg ) , as did primaquine ( treatment difference 399 % [ 21-59 ] , p = 00004 ) .
RESULTS	Adverse events were similar between treatments .
RESULTS	29 serious adverse events occurred in 26 ( 8 % ) of 329 patients ; QT prolongation was the most common serious adverse event ( 11 [ 3 % ] of 329 ) , occurring in five ( 2 % ) of 225 patients receiving tafenoquine , four ( 8 % ) of 50 patients receiving primaquine , and two ( 4 % ) of 54 patients receiving chloroquine alone , with no evidence of an additional effect on QT of chloroquine plus tafenoquine coadministration .
CONCLUSIONS	Single-dose tafenoquine 300 mg coadministered with chloroquine for P vivax malaria relapse prevention was more efficacious than chloroquine alone , with a similar safety profile .
CONCLUSIONS	As a result , it has been selected for further clinical assessment in phase 3 .
BACKGROUND	GlaxoSmithKline , Medicines for Malaria Venture .

###24240061
OBJECTIVE	To compare the effects of a combination of therapeutic exercise and ultrasound with or without additional microcurrent therapy in infants with congenital muscular torticollis involving the entire sternocleidomastoid muscle .
METHODS	Prospective , randomized , placebo-controlled trial .
METHODS	An outpatient rehabilitation clinic in a tertiary university hospital .
METHODS	Infants ( n = 20 ) with congenital muscular torticollis involving the entire sternocleidomastoid muscle .
METHODS	Group 1 comprised 10 infants who received therapeutic exercise with ultrasound alone and Group 2 comprised 10 infants who received the same treatment with microcurrent therapy .
METHODS	Passive cervical rotational range of motion was measured at before treatment and one , two , three , and six months after initial treatment .
METHODS	Thickness , cross-sectional area , and red pixel intensity on colour histograms , which were all assessed before treatment and at three months after initial treatment .
METHODS	Additionally , the duration of treatment was measured .
RESULTS	The mean passive cervical rotational range of motion measured at three months posttreatment was significantly greater in Group 2 ( 101.1 ) than that in Group 1 ( 86.4 ) , and the thickness , cross-sectional area , and red pixel intensity of the affected sternocleidomastoid muscle were all less in Group 2 ( 7.8 mm , 100.3 mm ( 2 ) , and 126.1 , respectively ) than those in Group 1 ( 9.6 mm , 121.5 mm2 , and 140.5 , respectively ) .
RESULTS	The mean duration of treatment was significantly shorter in Group 2 ( 2.6 months ) than in Group 1 ( 6.3 months ) .
CONCLUSIONS	Microcurrent therapy may increase the efficacy of therapeutic exercise with ultrasound for the treatment of congenital muscular torticollis involving the entire sternocleidomastoid muscle .

###25673441
BACKGROUND	Decreases in the bioavailability of rifampicin ( RFP ) can lead to the development of drug resistance and treatment failure .
BACKGROUND	Therefore , we investigated the relative bioavailability of RFP from one four-drug fixed-dose combination ( FDC ; formulation A ) and three two-drug FDCs ( formulations B , C , and D ) used in China , compared with RFP in free combinations of these drugs ( reference ) , in healthy volunteers .
METHODS	Eighteen and twenty healthy Chinese male volunteers participated in two open-label , randomized two-period crossover ( formulations A and C ) or one three-period crossover ( formulations B and D ) study , respectively .
METHODS	The washout period between treatments was 7 days .
METHODS	Bioequivalence was assessed based on 90 % confidence intervals , according to two one-sided t-tests .
METHODS	All analyses were done with DAS 3.1.5 ( Mathematical Pharmacology Professional Committee of China , Shanghai , China ) .
RESULTS	Mean pharmacokinetic parameter values of RFP obtained for formulations A , B , C , and D products were 11.42 3.41 g/ml , 7.86 5.78 g/ml , 13.05 6.80 g/ml , and 16.18 3.87 g/ml , respectively , for peak plasma concentration ( C max ) , 91.43 30.82 gh-1ml-1 , 55.49 37.58 gh-1ml-1 , 96.50 47.24 gh-1ml-1 , 101.47 33.07 gh-1ml-1 , respectively , for area under the concentration-time curve ( AUC 0-24 h ) .
CONCLUSIONS	Although the concentrations of RFP for formulations A , C , and D were within the reported acceptable therapeutic range , only formulation A was bioequivalent to the reference product .
CONCLUSIONS	The three two-drug FDCs ( formulations B , C and D ) displayed inferior RFP bioavailability compared with the reference ( Chinese Clinical Trials registration number : ChiCTR-TTRCC-12002451 ) .

###24501241
OBJECTIVE	Our aim was to ascertain the efficacy of golimumab compared with placebo in the prevention of atherosclerosis and arterial stiffness in AS .
METHODS	A randomized , double-blind , placebo-controlled pilot study was performed in which AS patients were treated with golimumab ( n = 20 ) and placebo ( n = 21 ) for 12 months .
METHODS	Patients from the placebo group who failed to achieve a 20 % response to Assessment of SpondyloArthritis international Society criteria ( ASAS20 ) at 6 months received open-label golimumab .
METHODS	Intima-media thickness ( IMT ) , pulse wave velocity ( PWV ) and augmentation index ( AIx ) were measured at baseline , 6 and 12 months .
RESULTS	At 6 months , 11/20 ( 55 % ) and 3/21 ( 14 % ) patients from the golimumab and placebo groups achieved an ASAS20 response , respectively ( P = 0.006 ) .
RESULTS	There was no significant difference in the change of the vascular parameters between the two groups .
RESULTS	In the placebo group , significantly greater progression of the mean IMT [ from 0.51 mm ( S.D. 0.07 ) at baseline to 0.53 mm ( S.D. 0.08 ) at 6 months , P = 0.044 ] and PWV ( from 12.2 m/s ( S.D. 1.6 ) at baseline to 12.6 m/s ( S.D. 1.3 ) , P = 0.028 ] were observed .
RESULTS	There was a trend towards progression of the mean IMT in the golimumab group ( P = 0.099 ) but the maximum IMT , PWV and AIx remained unchanged .
RESULTS	At 12 months the changes in vascular parameters were similar between the early and delayed ( or no ) golimumab groups .
CONCLUSIONS	Uncontrolled inflammation may result in a significant progression in IMT and PWV in patients with AS .
CONCLUSIONS	Arterial dysfunction may be prevented by golimumab over a period of 6 months , probably because of effective suppression of inflammation .
BACKGROUND	clinicaltrials.gov ( NCT01212653 )

###24955613
OBJECTIVE	This study investigated the dietary effect of including pigmented rice bran with or without plant sterols on lipid profiles during energy restriction-induced weight loss in overweight and obese adults not taking cholesterol-lowering medication .
OBJECTIVE	In addition , the study examined the effect of intervention on biomarkers of oxidative stress and inflammation .
METHODS	A group of 24 overweight and obese adults ( age : 43 6 years , body mass index 32 1 kg/m ( 2 ) , 18 females ) were randomized to a 25 % calorie-restricted diet containing either pigmented rice bran ( RB ) or the RB with addition of plant sterols ( RB+PS ) snack bars for 8 weeks .
METHODS	The individualized nutrient-balanced diet contained 70 % of daily energy needs assessed from indirect calorimetry measured resting energy expenditure ( EE ) and physical activity-related EE assessed using accelerometry .
METHODS	Anthropometrics , blood pressure , blood lipids , glucose , urinary F2-isoprostanes , C-reactive protein , insulin , and leptin were measured at baseline and after 8 weeks of intervention .
RESULTS	Participants lost approximately 4.7 2.2 kg ( p < 0.001 ) .
RESULTS	Weight loss was not significant between the RB+PS and RB group ( p = 0.056 ) .
RESULTS	Changes in body fat corresponded to changes in body weight .
RESULTS	Average decrease in total cholesterol was significantly higher in the RB+PS group than in the RB group ( difference 36 25 g/dL vs 7 16 g/dL ; p = 0.044 ) .
RESULTS	A similar pattern was observed for the decrease in low-density lipoprotein ( LDL ) cholesterol ( difference 22.3 25.2 g/dL vs 4.4 18.9 g/dL ; p = 0.062 ) .
RESULTS	Changes in systolic blood pressure , serum levels of leptin , and F2-isoprostanes were significant between baseline values and after 8 weeks on the diet in both groups ( p < 0.05 ) but did not differ between the 2 groups .
CONCLUSIONS	A nutrient-balanced and energy-restricted diet supplemented with rice bran and plant sterols resulted in a significant decrease in total and LDL cholesterol in overweight and obese adults .

###25577914
OBJECTIVE	To evaluate efficacy and safety of Baimai ointment ( see symbol in text ) in the treatment of wrist-dysfunction after distal radius fracture .
METHODS	From April , 2011 to June , 2012 , 43 patients with distal radius fracture were treated with plaster fixation .
METHODS	All the patients were divided into two group : test group and control group .
METHODS	Twenty-one patients in test group and 22 in control group , and the baseline was balance ( P > 0.05 ) .
METHODS	The 21 patients in test group were treated with Baimai ointment ( see symbol in text ) , fomentation , functional exercises .
METHODS	The 22 patients in control group were treated with placebo , fomentation , functional exercises .
METHODS	Foment affected side wrist with wet towel in 20 min before medication , with the temperature between 50 degrees C and 60 degrees C. Smear drugs uniformly in range of 3 cm in the vicinity of palm stripes after drying ( about 3 g ) and take functional exercises for the activities of wrist and hand .
METHODS	Continuous follow the program per 8 hours once and follow-up for 8 weeks .
METHODS	The Wrist 's pain was assessed with VAS .
METHODS	The wrist 's activities were measured with the protractor of orthopedic .
METHODS	Measure The grip strength was measured with dynamometer .
METHODS	The wrist 's function were assessed with the table of Cooney .
RESULTS	The test group had a significantly better results than those of control group in the extent of wrist 's pain throughout the treatment ( P < 0.001 ) , and grip strength on the 28th day and the 56th day ( P < 0.05 ) , and Cooney functional assessment on the 56th day ( P < 0.05 ) .
RESULTS	Wrist 's activities had no significane difference throughout the 8 weeks ( P > 0.05 ) .
RESULTS	There were no drug adverse reactions occurred .
CONCLUSIONS	Tibetan Baimai ointment ( see symbol in text ) has the treatment of wrist-dysfunction after distal radius fracture for external use , which can reduce the extent of wrist 's pain , promote grip strength recovery in the middle and late of process , promote wrist 's function recovery latterly , and safety for external use .

###24333490
OBJECTIVE	This study aimed to investigate the effect of both history of intermittent atrial tachyarrhythmias ( IAT ) and in-trial IAT on the risk of heart failure ( HF ) or death comparing cardiac resynchronization therapy with defibrillator ( CRT-D ) to implantable cardioverter-defibrillator ( ICD ) treatment in mildly symptomatic HF patients with left bundle branch block ( LBBB ) .
BACKGROUND	Limited data exist regarding the benefit of CRT-D in patients with IAT .
METHODS	The benefit of CRT-D in reducing the risk of HF/death was evaluated using multivariate Cox models incorporating the presence of , respectively , a history of IAT at baseline and time-dependent development of in-trial IAT during follow-up in 1,264 patients with LBBB enrolled in the MADIT-CRT ( Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy ) study .
RESULTS	The overall beneficial effect of CRT-D versus ICD on the risk of HF/death was not significantly different between LBBB patients with or without history of IAT ( HR : 0.50 , p = 0.028 , and HR : 0.46 , p < 0.001 , respectively ; p for interaction = 0.79 ) .
RESULTS	Among patients who had in-trial IAT , CRT-D was associated with a significant 57 % reduction in the risk of HF/death compared with ICD-only therapy ( HR : 0.43 , p = 0.047 ) , similar to the effect of the device among patients who did not have IAT ( HR : 0.47 , p < 0.001 ; p for interaction = 0.85 ) .
RESULTS	The percentage of patients with biventricular pacing 92 % was similar in both groups ( p = 0.43 ) .
RESULTS	Consistent results were shown for the benefit of CRT-D among patients who had in-trial atrial fibrillation/flutter ( HR : 0.30 , p = 0.027 ; p for interaction = 0.41 ) .
CONCLUSIONS	In the MADIT-CRT study , the clinical benefit of CRT-D in LBBB patients was not attenuated by prior history of IAT or by the development of in-trial atrial tachyarrhythmias .
CONCLUSIONS	( MADIT-CRT : Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy ; NCT00180271 ) .

###24534204
BACKGROUND	QVA149 is a novel , inhaled , once-daily dual bronchodilator containing a fixed-dose combination of the long-acting 2-agonist indacaterol and the long-acting muscarinic antagonist glycopyrronium ( NVA237 ) , for the treatment of chronic obstructive pulmonary disease ( COPD ) .
BACKGROUND	This study evaluated the effects of QVA149 on exercise tolerance , hyperinflation , lung function and lung volumes versus placebo and tiotropium .
METHODS	Patients with moderate-to-severe COPD were randomized to QVA149 110/50 g , placebo or tiotropium 18 g once daily in a blinded , 3-period crossover study for 3 weeks .
METHODS	The primary endpoint was exercise endurance time at Day 21 for QVA149 versus placebo .
RESULTS	Eighty-five patients were randomized ; 86 % completed the study .
RESULTS	QVA149 significantly improved exercise endurance time at Day 21 compared with placebo ( least squares mean treatment difference 60 s [ p = 0.006 ] ) .
RESULTS	No significant improvements in exercise endurance time at Day 21 between QVA149 and tiotropium were found .
RESULTS	Dynamic inspiratory capacity ( IC ) at exercise isotime , trough forced expiratory volume in 1 s , residual volume and functional residual capacity showed significant improvements with QVA149 from Day 1 of treatment that were maintained throughout the study .
RESULTS	The safety profiles were similar across groups .
CONCLUSIONS	In patients with moderate-to-severe COPD , once-daily QVA149 significantly improved exercise endurance time compared with placebo which was associated with sustained reductions of lung hyperinflation as indicated by significant improvement in IC at rest and during exercise .
BACKGROUND	ClinicalTrials.gov NCT01294787 .
CONCLUSIONS	Dual bronchodilation with QVA149 decreases lung hyperinflation and improves exercise tolerance and lung function in patients with moderate-to-severe COPD .

###24493100
OBJECTIVE	Persons with type 2 diabetes mellitus ( T2DM ) are at increased risk for decline in cognitive function , reduced brain volume , and increased white matter lesions in the brain .
OBJECTIVE	Poor control of blood pressure ( BP ) and lipid levels are risk factors for T2DM-related cognitive decline , but the effect of intensive treatment on brain function and structure is unknown .
OBJECTIVE	To examine whether intensive therapy for hypertension and combination therapy with a statin plus a fibrate reduces the risk of decline in cognitive function and total brain volume ( TBV ) in patients with T2DM .
METHODS	A North American multicenter clinical trial including 2977 participants without baseline clinical evidence of cognitive impairment or dementia and with hemoglobin A1c ( HbA1c ) levels less than 7.5 % randomized to a systolic BP goal of less than 120 vs less than 140 mm Hg ( n = 1439 ) or to a fibrate vs placebo in patients with low-density lipoprotein cholesterol levels less than 100 mg/dL ( n = 1538 ) .
METHODS	Participants were recruited from August 1 , 2003 , through October 31 , 2005 , with the final follow-up visit by June 30 , 2009 .
METHODS	Cognition was assessed at baseline and 20 and 40 months .
METHODS	A subset of 503 participants underwent baseline and 40-month brain magnetic resonance imaging to assess for change in TBV and other structural measures of brain health .
RESULTS	Baseline mean HbA1c level was 8.3 % ; mean age , 62 years ; and mean duration of T2DM , 10 years .
RESULTS	At 40 months , no differences in cognitive function were found in the intensive BP-lowering trial or in the fibrate trial .
RESULTS	At 40 months , TBV had declined more in the intensive vs standard BP-lowering group ( difference , -4.4 [ 95 % CI , -7.8 to -1.1 ] cm ( 3 ) ; P = .01 ) .
RESULTS	Fibrate therapy had no effect on TBV compared with placebo .
CONCLUSIONS	In participants with long-standing T2DM and at high risk for cardiovascular events , intensive BP control and fibrate therapy in the presence of controlled low-density lipoprotein cholesterol levels did not produce a measurable effect on cognitive decline at 40 months of follow-up .
CONCLUSIONS	Intensive BP control was associated with greater decline in TBV at 40 months relative to standard therapy .
CONCLUSIONS	TRIAL REGISTRATION clinicaltrials.gov Identifier : NCT00000620 .

###24330763
BACKGROUND	Providing women with contraceptive methods following abortion is important to reduce repeat abortion rates , yet evidence for effective post-abortion family planning interventions are limited .
BACKGROUND	This protocol outlines the evaluation of a mobile phone-based intervention using voice messages to support post-abortion family planning in Cambodia .
METHODS	A single blind randomised controlled trial of 500 participants .
METHODS	Clients aged 18 or over , attending for abortion at four Marie Stopes International clinics in Cambodia , owning a mobile phone and not wishing to have a child at the current time are randomised to the mobile phone-based intervention or control ( standard care ) with a 1:1 allocation ratio.The intervention comprises a series of six automated voice messages to remind clients about available family planning methods and provide a conduit for additional support .
METHODS	Clients can respond to message prompts to request a phone call from a counsellor , or alternatively to state they have no problems .
METHODS	Clients requesting to talk to a counsellor , or who do not respond to the message prompts , receive a call from a Marie Stopes International Cambodia counsellor who provides individualised advice and support regarding family planning .
METHODS	The duration of the intervention is 3 months .
METHODS	The control group receive existing standard of care without the additional mobile phone-based support.We hypothesise that the intervention will remind clients about contraceptive methods available , identify problems with side effects early and provide support , and therefore increase use of post-abortion family planning , while reducing discontinuation and unsafe method switching.Participants are assessed at baseline and at 4 months .
METHODS	The primary outcome measure is use of an effective modern contraceptive method at 4 months post abortion .
METHODS	Secondary outcome measures include contraception use , pregnancy and repeat abortion over the 4-month post-abortion period.Risk ratios will be used as the measure of effect of the intervention on the outcomes , and these will be estimated with 95 % confidence intervals .
METHODS	All analyses will be based on the ` intention to treat ' principle .
CONCLUSIONS	This study will provide evidence on the effectiveness of a mobile phone-based intervention using voice messages to support contraception use in a population with limited literacy .
CONCLUSIONS	Findings could be generalisable to similar populations in different settings .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01823861 .

###24777973
BACKGROUND	Cognitive-behavioural treatment can nowadays be delivered through the Internet .
BACKGROUND	This form of treatment can have various advantages with regard to availability and accessibility .
BACKGROUND	Previous studies showed that Internet-based treatment for chronic pain is effective compared to waiting-list control groups .
METHODS	We conducted a randomized controlled trial comparing an Internet-based cognitive-behavioural intervention with e-mail therapist contact to a face-to-face cognitive-behavioural group intervention .
METHODS	Of the 72 participants who were randomly assigned to an Internet or a group course , 50 participants completed the intervention .
METHODS	Participants were assessed at baseline ( T0 ) , immediately after the 7-week course ( T1 ) and at the booster session 2 months later ( T2 ) .
METHODS	Pain-related catastrophizing was the primary outcome measure .
METHODS	Pain intensity , fatigue , pain-related interference , locus of control , pain coping , global health-related quality of life and medical expenses were secondary outcome variables .
RESULTS	Significant improvement was found on catastrophizing , pain coping , locus of control and aspects of global health-related quality of life in both the Internet and the group courses directly after the course and at the booster session .
RESULTS	Pain intensity was improved in both courses at the booster session .
RESULTS	At T2 , improvement in catastrophizing , pain intensity , pain coping and some quality of life dimensions was significantly greater in completers of the Internet course than in the group course .
RESULTS	Furthermore , the Internet course was cost-effective compared to the group course .
CONCLUSIONS	We conclude that the Internet-based cognitive-behavioural intervention was at least as effective as the face-to-face group intervention and , on some outcome measures appeared to be even more effective .

###24358480
OBJECTIVE	To describe the prevalence and risk factors for incomplete bladder emptying after midurethral slings ( MUS ) in a large multicenter trial .
METHODS	Five hundred ninety-seven women were randomized to retropubic ( RMUS ) or transobturator midurethral slings as part of the Trial of MidUrethral Slings study .
METHODS	Demographic data and voiding symptoms were obtained preoperatively along with urodynamics .
METHODS	Patients underwent a standardized voiding trial at discharge after continence surgery .
METHODS	Incomplete bladder emptying was defined as a postvoid residual of > 150 mL .
RESULTS	Three-quarters of patients ( 454 of 597 ) were self-voiding at discharge , whereas 114 of 597 ( 19 % ) were managed with an indwelling urethral catheter and 29 of 597 ( 5 % ) with intermittent catheterization .
RESULTS	At 2 weeks , only 38 of 586 ( 6 % ) reported any catheter use , and by 6 weeks , only 9 of 587 ( 2 % ) reported any catheter use .
RESULTS	Women with incomplete bladder emptying at discharge were more likely to have had a RMUS ( odds ratio 1.79 ; 95 % confidence interval 1.22-2 .62 ) and to report preoperative voiding accommodations such as straining to void ( odds ratio 1.75 ; 95 % confidence interval 1.04-2 .96 ) .
RESULTS	Urodynamic and clinicodemographic parameters were not predictive of incomplete bladder emptying .
CONCLUSIONS	Incomplete bladder emptying at discharge after MUS is common , especially after RMUS , but of short duration .
CONCLUSIONS	Risk factors include preoperative voiding accommodations such as straining or bending over to void , but other variables including urodynamics did not predict incomplete bladder emptying after MUS .

###25134497
BACKGROUND	The prevalence and socioeconomic cost of late life depression ( LLD ) is on the rise , while the response rate to antidepressant trials remains poor .
BACKGROUND	Various mind-body therapies are being embraced by patients as they are considered safe and potentially effective , yet little is known regarding the effectiveness of such therapies to improve LLD symptoms .
BACKGROUND	Among the mind-body therapies currently in practice , the results of our pilot study have shown that a particular meditation technique called Sahaj Samadhi Meditation , which belongs to the category of meditation termed automatic self-transcending meditation ( ASTM ) may have some promise in improving cardiovascular autonomic disturbances associated with LLD as well as ameliorating symptoms of depression and anxiety .
METHODS	Patients between the ages of 60 and 85 with LLD will be randomized either to ASTM plus treatment as usual ( TAU ) or TAU alone to assess changes in cardiovascular autonomic parameters , neuropsychological symptoms of depression and anxiety as well as quality of life .
METHODS	The instructional phase of the intervention consists of 4 consecutive days of meditation training , after which participants are encouraged to meditate twice daily for twenty minutes each time at home .
METHODS	The intervention also includes once weekly follow up sessions for the subsequent 11 weeks .
METHODS	The planned study has one and a half year recruitment period .
METHODS	Participants will be assessed at baseline and at 4 , 8 , 12 and 24 weeks post intervention .
CONCLUSIONS	This study should provide a unique data source from a randomized , controlled , longitudinal trial to investigate the effects of a form of ASTM on cardiovascular autonomic and neuropsychological health in LLD .
BACKGROUND	Clinicaltrials.gov NCT02149810 , date registered : 05/28/2014 .

###25055821
BACKGROUND	Acupuncture is safe and may be effective for severe chronic constipation .
BACKGROUND	The World Gastroenterology Organisation recommends prucalopride for patients for whom previous laxative use failed to provide satisfactory relief .
METHODS	In this prospective , multi-centre , randomised controlled trial , five hundred sixty patients with severe chronic constipation ( two or less spontaneous complete bowel movements per week ) from 14 centres will be randomised to receive either electroacupuncture or prucalopride .
METHODS	Participants in the electroacupuncture group will receive electroacupuncture for eight weeks , while participants in the control group will take prucalopride ( 2 mg once daily ) for 32 weeks .
METHODS	The primary outcome measure is the proportion of patients having 3 spontaneous , complete bowel movements per week , averaged over week three to eight .
METHODS	The secondary outcome measures include eight items , including the proportion of patients having 3 spontaneous , complete bowel movements per week averaged over week 9-32 , the proportion of patients with one or more increases in spontaneous , complete bowel movements per week from baseline , mean Bristol Stool Scale , etc. .
METHODS	Statistical analysis will include the CMH test , nonparametric tests and t tests .
CONCLUSIONS	We aimed to compare the effect of electroacupuncture versus prucalopride for severe chronic constipation .
CONCLUSIONS	The limitation of this study is that participants and acupuncturists will not be blinded .
BACKGROUND	ClinicalTrials.gov Identifier : NCT 02047045 .

###24327175
OBJECTIVE	It was investigated whether oral dexamethasone ( DEX ) administration improves exercise performance by reducing the initial rate of muscle fatigue development during dynamic exercise .
METHODS	Using a double-blinded placebo controlled randomized crossover design , subjects ingested either 2 2 mg of DEX or placebo for five consecutive days .
METHODS	Muscle function was investigated using one-legged kicking exercise and whole body performance was evaluated using a 20-m shuttle run and a 30-m sprint test .
RESULTS	One-legged dynamic knee-extensor exercise time to exhaustion was 29 35 % ( mean SD ) longer ( P < 0.05 ) in DEX compared to Placebo .
RESULTS	Likewise , total running distance in the shuttle run test was 19 23 % longer ( P < 0.05 ) , whereas 30-m sprint performance was unaltered .
RESULTS	During the initial 75 s of dynamic leg extensions , peak force and rate of force development determined from an electrically evoked twitch declined in a similar way in DEX and placebo .
RESULTS	Similarly , the EMG root mean square was similar with DEX and placebo treatment .
CONCLUSIONS	Short-term dexamethasone administration increases high-intensity one-legged kicking time to exhaustion and 20-m shuttle run performance , although sprint ability and the initial loss of muscular force generating capacity are similar after DEX and placebo .

###24499959
OBJECTIVE	The aim of the present study was to determine ( 1 ) whether successful intraoperative electromyography monitoring for lateral spread response ( LSR ) is possible with partial neuromuscular blockade ( NMB ) in subjects undergoing microvascular decompression ( MVD ) for hemifacial spasm and ( 2 ) the adequate level of NMB to achieve that goal .
METHODS	A total of 61 patients in whom LSR was monitored during MVD were enrolled in the study .
METHODS	Patients were randomly allocated to two groups : group TOF in which the NMB target was maintenance of two train-of-four ( TOF ) counts and group T1 in which the NMB target was maintenance of a T1/Tc ratio of 50 % ( T1 : first twitch height of TOF and Tc : control twitch height ) .
METHODS	The adductor pollicis brevis muscle was used to monitor TOF responses .
METHODS	The frequency of successful LSR monitoring , defined as successful baseline establishment and maintenance of LSR until surgical decompression , was compared between the two groups .
RESULTS	Of the 61 patients 2 were excluded from the study so that 30 patients in group TOF and 29 patients in group T1 were analyzed .
RESULTS	The success rate of LSR monitoring was clinically acceptable and significantly higher in group T1 than in group TOF , i.e. n = 15 ( 50.0 % ) in group TOF versus n = 24 ( 82.8 % ) in group T1 ( P = 0.008 ) , corresponding to a 32.8 % higher success rate in group T1 than group TOF ( 95 % CI : 13.9-51 .7 % ) .
RESULTS	Mean vecuronium infusion dose was smaller and mean TOF count was higher in group T1 than group TOF with a TOF count = 2 ( 1 ) in group TOF versus 3 ( 1 ) in group T1 ( P = 0.003 ) .
RESULTS	Mean sevoflurane and remifentanil infusion doses were not different between groups .
RESULTS	There was no incidence of spontaneous movement during microscopy in either group .
CONCLUSIONS	Maintenance of partial NMB with a target T1/Tc ratio of 50 % resulted in a clinically acceptable success rate of LSR monitoring and surgical condition during MVD .
CONCLUSIONS	Maintenance of partial NMB with a target T1/Tc ratio of 50 % rather than TOF count of two during LSR monitoring for MVD can therefore be recommended .

###25502128
BACKGROUND	The United States spends a higher percentage of its gross domestic product on health care than any other country .
BACKGROUND	Previous efforts to curtail health care spending have had minimal impact .
BACKGROUND	We hypothesized that informing physicians of the cost of expensive cardiovascular diagnostic tests would change their ordering behavior .
METHODS	Hospitalist physicians ( n = 38 ) were randomly assigned to either seeing or not seeing the cost of diagnostic tests , via a computer pop-up screen , at the time of order entry .
METHODS	Patients were inpatients on a general medical service .
METHODS	Cost-aware physicians were shown the cost of the test they ordered as well as the cost of similar tests with different costs .
METHODS	There was a 4-month baseline period prior to randomization followed by a 4-month intervention period .
METHODS	The primary outcome measure was a change in the proportion of imaging stress tests in the study period .
RESULTS	Of the total number of stress tests ordered ( imaging and nonimaging ) , cost-aware physicians ordered 89 % of their tests with imaging during both the baseline and study periods .
RESULTS	Cost-unaware physicians ordered 91 % imaging tests during the baseline period and 87 % during the study period .
RESULTS	There were no significant differences between the groups regarding change in ordering from baseline to study period .
RESULTS	Both groups showed a slight increase ( P < 0.03 ) in ordering the more expensive regadenoson nuclear stress tests ( cost-aware : 30 % baseline , 44 % study period ; cost-unaware : 36 % baseline , 41 % study period ) .
CONCLUSIONS	Informing physicians of the cost of certain diagnostic tests is not a sufficient intervention to influence their ordering behavior .

###24613908
OBJECTIVE	Clinical benefit response ( CBR ) , based on changes in pain , Karnofsky performance status , and weight , is an established palliative endpoint in trials for advanced gastrointestinal cancer .
OBJECTIVE	We investigated whether CBR is associated with survival , and whether CBR reflects a wide-enough range of domains to adequately capture patients ' perception .
METHODS	CBR was prospectively evaluated in an international phase III chemotherapy trial in patients with advanced pancreatic cancer ( n = 311 ) in parallel with patient-reported outcomes ( PROs ) .
RESULTS	The median time to treatment failure was 3.4 months ( range : 0-6 ) .
RESULTS	The majority of the CBRs ( n = 39 ) were noted in patients who received chemotherapy for at least 5 months .
RESULTS	Patients with CBR ( n = 62 ) had longer survival than non-responders ( n = 182 ) ( hazard ratio = 0.69 ; 95 % confidence interval : 0.51-0 .94 ; p = 0.013 ) .
RESULTS	CBR was predicted with a sensitivity and specificity of 77-80 % by various combinations of 3 mainly physical PROs .
RESULTS	A comparison between the duration of CBR ( n = 62 , median = 8 months , range = 4-31 ) and clinically meaningful improvements in the PROs ( n = 100-116 ; medians = 9-11 months , range = 4-24 ) showed similar intervals .
CONCLUSIONS	CBR is associated with survival and mainly reflects physical domains .
CONCLUSIONS	Within phase III chemotherapy trials for advanced gastrointestinal cancer , CBR can be replaced by a PRO evaluation , without losing substantial information but gaining complementary information .

###24654314
OBJECTIVE	MP29-02 ( Dymista ) , a novel intranasal formulation of azelastine hydrochloride ( AZE ) and fluticasone propionate ( FP ) , is significantly better than first-line therapy for the treatment of moderate-to-severe seasonal allergic rhinitis ( SAR ) , and is well tolerated following 52 weeks of continuous use in chronic rhinitis .
OBJECTIVE	The aim of this study was to evaluate the long-term efficacy of MP29-02 versus FP in patients with chronic rhinitis .
METHODS	In total , 612 chronic rhinitis patients ( perennial allergic rhinitis [ PAR ] , n = 424 ; nonallergic rhinitis , n = 188 ) aged 12 years or older were enrolled into this open-label , parallel-group study and randomized to MP29-02 ( 1 spray/nostril bid ) or FP nasal spray ( 2 sprays/nostril qd ) for 52 weeks .
METHODS	Efficacy was assessed by change from baseline in PM reflective total nasal symptom score ( rTNSS ) , time to first achieve 100 % PM rTNSS reduction from baseline , and percentage of symptom-free days in the total and PAR populations posthoc .
RESULTS	MP29-02 reduced patients ' PM rTNSS from baseline significantly more than FP , from Day 1 up to and including week 28 ( -2.88 vs -2.53 ; P = .0048 ) , with treatment difference maintained for 52 weeks .
RESULTS	Fluctuation in significance after week 28 might be explained , at least in part , by decreasing sample size , permitted according to ICH guidelines .
RESULTS	By Day 1 almost twice as many MP29-02-patients were symptom free .
RESULTS	After 1 month , 71.1 % of MP29-02 patients experienced 100 % rTNSS reduction ( 60.3 % for FP ) , and did on a median of 9 days faster ( P = .0024 ) .
RESULTS	Over 52 weeks MP29-02 patients experienced 8.4 % more symptom-free days ( P = .0005 ) .
RESULTS	These results were mirrored in the PAR subpopulation .
CONCLUSIONS	These results confirm MP29-02 's wide therapeutic spectrum and assert its consistent superiority over an intranasal corticosteroid .

###24268105
BACKGROUND	The clinical benefit of preventive eradication of unruptured brain arteriovenous malformations remains uncertain .
BACKGROUND	A Randomised trial of Unruptured Brain Arteriovenous malformations ( ARUBA ) aims to compare the risk of death and symptomatic stroke in patients with an unruptured brain arteriovenous malformation who are allocated to either medical management alone or medical management with interventional therapy .
METHODS	Adult patients ( 18 years ) with an unruptured brain arteriovenous malformation were enrolled into this trial at 39 clinical sites in nine countries .
METHODS	Patients were randomised ( by web-based system , in a 1:1 ratio , with random permuted block design [ block size 2 , 4 , or 6 ] , stratified by clinical site ) to medical management with interventional therapy ( ie , neurosurgery , embolisation , or stereotactic radiotherapy , alone or in combination ) or medical management alone ( ie , pharmacological therapy for neurological symptoms as needed ) .
METHODS	Patients , clinicians , and investigators are aware of treatment assignment .
METHODS	The primary outcome is time to the composite endpoint of death or symptomatic stroke ; the primary analysis is by intention to treat .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00389181 .
RESULTS	Randomisation was started on April 4 , 2007 , and was stopped on April 15 , 2013 , when a data and safety monitoring board appointed by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health recommended halting randomisation because of superiority of the medical management group ( log-rank Z statistic of 410 , exceeding the prespecified stopping boundary value of 287 ) .
RESULTS	At this point , outcome data were available for 223 patients ( mean follow-up 333 months [ SD 197 ] ) , 114 assigned to interventional therapy and 109 to medical management .
RESULTS	The primary endpoint had been reached by 11 ( 101 % ) patients in the medical management group compared with 35 ( 307 % ) in the interventional therapy group .
RESULTS	The risk of death or stroke was significantly lower in the medical management group than in the interventional therapy group ( hazard ratio 027 , 95 % CI 014-054 ) .
RESULTS	No harms were identified , other than a higher number of strokes ( 45 vs 12 , p < 00001 ) and neurological deficits unrelated to stroke ( 14 vs 1 , p = 00008 ) in patients allocated to interventional therapy compared with medical management .
CONCLUSIONS	The ARUBA trial showed that medical management alone is superior to medical management with interventional therapy for the prevention of death or stroke in patients with unruptured brain arteriovenous malformations followed up for 33 months .
CONCLUSIONS	The trial is continuing its observational phase to establish whether the disparities will persist over an additional 5 years of follow-up .
BACKGROUND	National Institutes of Health , National Institute of Neurological Disorders and Stroke .

###25002731
OBJECTIVE	Corticosteroids are frequently used in cancer pain management despite limited evidence .
OBJECTIVE	This study compares the analgesic efficacy of corticosteroid therapy with placebo .
METHODS	Adult patients with cancer receiving opioids with average pain intensity 4 ( numeric rating scale [ NRS ] , 0 to 10 ) in the last 24 hours were eligible .
METHODS	Patients were randomly assigned to methylprednisolone ( MP ) 16 mg twice daily or placebo ( PL ) for 7 days .
METHODS	Primary outcome was average pain intensity measured at day 7 ( NRS , 0 to 10 ) ; secondary outcomes were analgesic consumption ( oral morphine equivalents ) , fatigue and appetite loss ( European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire C30 , 0 to 100 ) , and patient satisfaction ( NRS , 0 to 10 ) .
RESULTS	A total of 592 patients were screened ; 50 were randomly assigned , and 47 were analyzed .
RESULTS	Baseline opioid level was 269.9 mg in the MP arm and 160.4 mg in the PL arm .
RESULTS	At day-7 evaluation , there was no difference between the groups in pain intensity ( MP , 3.60 v PL , 3.68 ; P = .88 ) or relative analgesic consumption ( MP , 1.19 v PL , 1.20 ; P = .95 ) .
RESULTS	Clinically and statistically significant improvements were found in fatigue ( -17 v 3 points ; P .003 ) , appetite loss ( -24 v 2 points ; P = .003 ) , and patient satisfaction ( 5.4 v 2.0 points ; P = .001 ) in favor of the MP compared with the PL group , respectively .
RESULTS	There were no differences in adverse effects between the groups .
CONCLUSIONS	MP 32 mg daily did not provide additional analgesia in patients with cancer receiving opioids , but it improved fatigue , appetite loss , and patient satisfaction .
CONCLUSIONS	Clinical benefit beyond a short-term effect must be examined in a future study .

###25298420
OBJECTIVE	To investigate the role of epoxyeicosatrienoic acids ( EETs ) and prostaglandins ( PGs ) in retinal blood vessel calibers and vasodilation during flicker light stimulation in humans .
METHODS	Twelve healthy nonsmokers participated in a balanced crossover study .
METHODS	Oral fluconazole 400 mg and dispersible aspirin 600 mg were used to inhibit production of EETs and PGs , respectively .
METHODS	Retinal imaging was performed 1 hour after drug ingestion with the Dynamic Vessel Analyzer .
METHODS	Resting calibers of selected vessel segments were recorded in measurement units ( MU ) .
METHODS	Maximum percentage dilations during flicker stimulation were calculated from baseline calibers .
METHODS	We then studied six participants each after fluconazole and aspirin ingestions at 30-minute intervals for 2 hours .
METHODS	Within-subject differences were assessed by ANOVA and Dunnett-adjusted pairwise comparisons with significance taken at P < 0.05 .
RESULTS	In crossover study participants , mean ( SD ) arteriole and venule dilations without drug administration were 4.4 % ( 2.0 % ) and 4.6 % ( 1.7 % ) , respectively .
RESULTS	Neither drug affected vasodilation during flicker stimulation .
RESULTS	Mean ( SD ) resting arteriole and venule calibers on no-drug visits were 119.6 ( 10.6 ) MU and 145.7 ( 17.0 ) MU , respectively .
RESULTS	Fluconazole reduced mean ( 95 % CI ) resting venule calibers by 5.1 ( 4.3 ) MU .
RESULTS	In repeated measures participants , neither drug affected vasodilations , but fluconazole reduced resting venule calibers over 2 hours ( P < 0.001 ) .
CONCLUSIONS	Epoxyeicosatrienoic acids and prostaglandins are unlikely to be primary mediators of flicker light-induced retinal vasodilation in humans .
CONCLUSIONS	However , EETs may play a role in the regulation of retinal vascular tone and blood flow under resting physiological conditions .

###24968790
BACKGROUND	HS219 ( 40 mg chitosan-loaded chewing gum ) is designed to bind salivary phosphorus as an add-on to available phosphorus binders .
BACKGROUND	We performed a randomized , placebo-controlled , double-blind study to evaluate the efficacy and safety of HS219 in hemodialysis ( HD ) patients with hyperphosphatemia as an add-on to phosphorus binders .
METHODS	Sixty-eight HD patients who were maintained on calcium carbonate ( n = 33 ) or sevelamer hydrochloride ( n = 35 ) were enrolled .
METHODS	The primary end point was a change in serum phosphorus levels .
METHODS	Secondary end points included changes in levels of salivary phosphorus , serum calcium , parathyroid hormone ( PTH ) , and intact fibroblast growth factor ( iFGF ) 23 .
RESULTS	Sixty-three patients chewed either HS219 ( n = 35 ) or placebo ( n = 28 ) for 30 min , three times a day , for 3 weeks .
RESULTS	HS219 was well tolerated and safe .
RESULTS	However , HS219 was not superior to placebo with additional reduction of serum phosphorus with respect to phosphorus binders at the end of the chewing period .
RESULTS	There were no significant effects of HS219 on reduction of salivary phosphorus , serum calcium , iPTH , or iFGF23 levels .
CONCLUSIONS	The chitosan-loaded chewing gum HS219 does not affect serum and salivary phosphorus levels in Japanese HD patients with hyperphosphatemia .
CONCLUSIONS	Our findings do not support previous findings that 20 mg of chitosan-loaded chewing gum reduces serum and salivary phosphorus levels .
BACKGROUND	[ corrected ] ClinicalTrials.gov NCT01039428 , 24 December , 2009 .

###24345027
BACKGROUND	Dietary guidelines suggest limiting daily sodium intake to < 2,300 mg for the general population , and < 1,500 mg/d for those with certain cardiovascular risk factors .
BACKGROUND	Despite these recommendations , few Americans are able to achieve this goal .
BACKGROUND	Identifying challenges in meeting these guidelines is integral for successful compliance .
BACKGROUND	This analysis examined patterns and amount of daily sodium intake among participants with metabolic syndrome enrolled in a one-year dietary intervention study .
METHODS	Two hundred forty participants with metabolic syndrome enrolled in a dietary intervention trial to lose weight and improve dietary quality .
METHODS	Three 24-hour dietary recalls were collected at each visit which provided meal patterns and nutrient data , including sodium intake .
METHODS	A secondary data analysis was conducted to examine sodium consumption patterns at baseline and at one-year study visits .
METHODS	Sodium consumption patterns over time were examined using linear mixed models .
RESULTS	The percentage of meals reported eaten in the home at both baseline and one-year follow-up was approximately 69 % .
RESULTS	Follow-up for the one-year dietary intervention revealed that the participants who consumed sodium greater than 2,300 mg/d declined from 75 % ( at baseline ) to 59 % , and those that consumed higher than 1,500 mg/d declined from 96 % ( at baseline ) to 85 % .
RESULTS	Average sodium intake decreased from 2,994 mg at baseline to 2,558 mg at one-year ( P < 0.001 ) , and the sodium potassium ratio also decreased from 1.211 to 1.047 ( P < 0.001 ) .
RESULTS	Sodium intake per meal varied significantly by meal type , location , and weekday , with higher intake at dinner , in restaurants , and on weekends .
RESULTS	At-home lunch and dinner sodium intake decreased ( P < 0.05 ) , while dinner sodium intake at restaurant/fast food chains increased from baseline to one-year ( P < 0.05 ) .
CONCLUSIONS	Sodium intake for the majority of participants exceeded the recommended dietary guidelines .
CONCLUSIONS	Findings support actions that encourage low-sodium food preparation at home and encourage public health policies that decrease sodium in restaurants and prepared foods .

###24690440
OBJECTIVE	To investigate the clinical efficacy and safety of an additional core vitrectomy to the standard therapy in patients with exudative age-related macular degeneration ( ARMD ) .
METHODS	In this prospective , controlled , single-centre study , 50 eyes of 50 patients ( mean age : 74.1 7.1 ; median 74 ( 69/78 ) ) with ARMD were enrolled and randomized 1:1 to group 1 - core vitrectomy additional to three times injections of ranibizumab ( 3x Rbz ) and Group 2 - 3x Rbz ( control ) .
METHODS	1 16 of 25 eyes in Group 1 ( 64 % ) and 12 of 25 ( 48 % ) in Group 2 had a posterior vitreous detachment ( PVD ) prior to start of the study .
METHODS	Changes in best-corrected visual acuity ( BCVA ) using ETDRS charts , central macular thickness and macular volume ( OCT ) as well as the rate of reinjection with an OCT-based pro renata ( PRN ) protocol were monitored prospectively over 48 weeks .
METHODS	Forty-seven eyes completed follow-up at week 48 .
RESULTS	In Group 1 , 4 of 24 lost 1 line of BCVA ( 16.7 % ) and 3 of 24 lost 2 lines ( 12.5 % ) , whereas 17 of 24 gained more than 1 line ( 70.8 % ) and improved in average by 9.8 letters .
RESULTS	In Group 2 , 3 of 23 remained stable and 20 of 23 gained more than or exactly 1 line ( 78.3 % ) , resulting in 14.3 letters , with no loss of lines .
RESULTS	Central macular thickness decreased by 85.58 m ( 28.8 % ) in Group 1 and by 121.43 m ( 32.68 % ) in Group 2 compared with baseline .
RESULTS	In Group 1 , four patients received three additional and two patients , two additional Rbz injections .
RESULTS	In Group 2 , three patients received three additional , three patients two and 12 patients one additional Rbz injections .
RESULTS	This yielded in an average injection rate of 3.66 in Group 1 and 4.17 in Group 2 over 48 weeks .
RESULTS	Posterior vitreous detachment ( PVD ) was identified in Group 1 in 16 of 24 ( 66.7 % ) and in Group 2 in 12 of 23 ( 52.2 % ) patients at baseline .
RESULTS	At week 48 , 6 of 8 ( 75 % ) of the patients in Group 1 with initial attached vitreous showed a vitreal detachment , whereas only 1 of 11 ( 9 % ) in Group 2 had a new occurred detachment of the vitreous .
RESULTS	No systemic or ocular adverse events were noticed .
CONCLUSIONS	An initial core vitrectomy combined with a conventional ranibizumab injection regimen for exudative AMD patients was safe and lead to similar functional results with less intravitreal ranibizumab injections over 48 weeks .

###25041377
OBJECTIVE	The pharmacokinetic ( PK ) similarity between PF-05280014 , a proposed trastuzumab biosimilar , trastuzumab sourced from European Union ( trastuzumab-EU ) or from United States ( trastuzumab-US ) was evaluated .
OBJECTIVE	Safety and immunogenicity were also assessed .
METHODS	In this phase 1 , double-blind trial ( NCT01603264 ) , 105 healthy male volunteers were randomized 1:1:1 to receive a single 6mgkg ( -1 ) intravenous dose of PF-05280014 , trastuzumab-EU , or trastuzumab-US , and evaluated for 70 days .
METHODS	Drug concentration-time data were analyzed by non-compartmental methods .
METHODS	PK similarity for the comparisons of PF-05280014 to each of trastuzumab-EU and trastuzumab-US , and trastuzumab-EU to trastuzumab-US were determined using the standard 80.00 % to 125.00 % bioequivalence criteria .
RESULTS	Baseline demographics for the 101 subjects evaluable for PK were similar across all arms .
RESULTS	The three products exhibited similar PK profiles with target-mediated disposition .
RESULTS	The 90 % CIs for the ratios of Cmax , AUC ( 0 , t last ) and AUC ( 0 , ) were within 80.00 % to 125.00 % for all three pairwise comparisons .
RESULTS	Adverse events ( AEs ) were similar across all arms with treatment-related AEs reported by 71.4 % , 68.6 % and 65.7 % subjects in the PF-05280014 , trastuzumab-EU , and trastuzumab-US arms , respectively .
RESULTS	The most common AEs were infusion-related reactions , headache , chills , pyrexia and nausea .
RESULTS	The AE term ` pyrexia ' was numerically greater in the PF-05280014 arm .
RESULTS	All post-dose samples , except 1 , tested negative for anti-drug antibodies ( ADA ) .
CONCLUSIONS	This study demonstrates PK similarity among PF-05280014 , trastuzumab-EU and trastuzumab-US .
CONCLUSIONS	The safety and immunogenicity profiles observed for the three products in this study are consistent with previous reports for trastuzumab .

###24330810
BACKGROUND	Dizziness is one of the most challenging symptoms in medicine .
BACKGROUND	No medication for dizziness in current use has well-established curative or prophylactic value or is suitable for long-term palliative use .
BACKGROUND	Unconventional remedies , such as acupuncture , should be considered and scientifically evaluated .
BACKGROUND	However , there has been relatively little evidence in randomized controlled clinical trials on acupuncture to treat chronic dizziness .
BACKGROUND	The aim of our study is to evaluate the efficacy and safety of acupuncture in patients with dizziness .
METHODS	This trial is a randomized , single-blind , controlled study .
METHODS	A total of 80 participants will be randomly assigned to two treatment groups receiving acupuncture and sham acupuncture treatment , respectively , for 4 weeks .
METHODS	The primary outcome measures are the Dizziness Handicap Inventory ( DHI ) and the Vertigo Symptom Scale ( VSS ) .
METHODS	Treatment will be conducted over a period of 4 weeks , at a frequency of two sessions per week .
METHODS	The assessment is at baseline ( before treatment initiation ) , 4 weeks after the first acupuncture session , and 8 weeks after the first acupuncture session .
CONCLUSIONS	The results from this study will provide clinical evidence on the efficacy and safety of acupuncture in patients with chronic dizziness .
BACKGROUND	International Standard Randomized Controlled Trial Number Register : ISRCTN52695239 .

###25752109
OBJECTIVE	To investigate the clinical effect of negative pressure drainage after septum surgery .
METHODS	One hundred and two cases with septum deviation were randomly divided into two groups , i. e. experimental group and controlling one .
METHODS	With 51 cases in each .
METHODS	Degree of comfort and complication of two groups were compared .
RESULTS	The cases in experimental group showed significantly relieved postoperative reaction with negative pressure drainage , when compared with that of controls , the incidence of complication were not increased .
CONCLUSIONS	Negative pressure drainage can be taken as one of the ideal materials for hemostasia after septum surgery .

###24957431
OBJECTIVE	To determine expression of apoptotic factors p53 and caspase-8 in human lens epithelial cells ( LECs ) of cataract patients with or without diabetic retinopathy ( DR ) , the duration of diabetes mellitus ( DM ) , and the level of glycated hemoglobin ( hemoglobin A1c [ HbA1c ] ) .
METHODS	St. Mary 's Hospital , Catholic University of Korea , Seoul , South Korea .
METHODS	Randomized prospective study .
METHODS	The LECs were isolated during cataract surgery .
METHODS	The isolated samples were classified into 4 groups as follows : patients without DM ( Group 1 ) , patients with DM but not DR ( Group 2 ) , diabetic patients with nonproliferative DR ( Group 3 ) , and diabetic patients with proliferative DR ( Group 4 ) .
METHODS	To explore the mechanism of apoptosis , the expressions of p53 and caspase-8 were measured by immunohistochemical staining and compared with the data according to the duration of DM , HbA1c levels , and severity of DR.
RESULTS	All groups comprised 15 eyes .
RESULTS	The expressions of P53 and caspase-8 were higher in Groups 2 , 3 , and 4 than in Group 1 ( P < .001 ) .
RESULTS	The expressions were statistically significantly increased with a longer duration of DM , higher HbA1c levels , and advanced DR.
CONCLUSIONS	The expressions of P53 and caspase-8 were strong in patients with DM and advanced DR. Knowledge of these relationships may lead to a better understanding of the development of diabetic cataract .
BACKGROUND	No author has a financial or proprietary interest in any material or method mentioned .

###24977689
OBJECTIVE	To evaluate the effectiveness of nonnutritive sucking ( NNS ) and oral stimulation ( OS ) , either applied alone or in combination , to reduce the transition time from tube feeding to independent oral feeding .
METHODS	Randomized controlled trial .
METHODS	A 40-bed neonatal ICU in a university hospital in the People 's Republic of China .
METHODS	A total of 120 preterm infants were admitted to the neonatal ICU from December 2012 to July 2013 .
METHODS	Oral motor interventions .
RESULTS	One hundred twelve preterm infants were assigned to three intervention groups ( NNS , OS , and combined NNS + OS ) and one control group .
RESULTS	Primary outcome was the number of days needed from introduction of oral feeding to autonomous oral feeding ( transition time ) .
RESULTS	Secondary outcome measures were the rate of milk transfer ( mL/min ) , proficiency ( intake first 5 min/volume ordered ) , volume transfer ( volume transferred during entire feeding/volume prescribed ) , weight , and hospital length of stay .
RESULTS	Transition time was reduced in the three intervention groups compared with the control group ( p < 0.001 ) .
RESULTS	The milk transfer rate in the three intervention groups was greater than in the control group ( F3 ,363 = 15.37 ; p < 0.001 ) .
RESULTS	Proficiency in the NNS and OS groups did not exceed that in the control group while the proficiency in the NNS + OS group was greater than that in the control group at the stage when the infants initiated the oral feeding ( p = 0.035 ) .
RESULTS	Among all groups , no significant difference was found on weight gain and length of stay .
CONCLUSIONS	The combined NNS + OS intervention reduced the transition time from introduction to independent oral feeding and enhanced the milk transfer rate .
CONCLUSIONS	The combined intervention seems to have a beneficial effect on oral feeding proficiency in preterm infants .

###24375332
BACKGROUND	Aromatase inhibitors ( AIs ) have been associated with decrements in patient-reported outcomes ( PROs ) .
BACKGROUND	The objective of this study was to assess whether real acupuncture ( RA ) , compared with sham acupuncture ( SA ) , improves PROs in patients with breast cancer who are receiving an adjuvant AI .
METHODS	Postmenopausal women with a stage 0 through III breast cancer who received an AI and had treatment-associated musculoskeletal symptoms were randomized to receive 8 weekly RA versus SA in a dual-center , randomized controlled trial .
METHODS	The National Surgical Adjuvant Breast and Bowel Project ( NSABP ) menopausal symptoms questionnaire , the Center for Epidemiological Studies Depression ( CESD ) scale , the Hospital Anxiety and Depression Scale ( HADS ) , the Pittsburgh Sleep Quality Index ( PSQI ) , the hot flash daily diary , the Hot Flash-Related Daily Interference Scale ( HFRDI ) , and the European quality-of-life survey ( EuroQol ) were used to assess PROs at baseline and at 4weeks , 8 weeks , and 12 weeks .
RESULTS	The intention-to-treat analysis included 23 patients in the RA arm and 24 patients in the SA arm .
RESULTS	There were no significant differences in baseline characteristics between the 2 groups .
RESULTS	Compared with baseline , scores in the RA arm improved significantly at week 8 on the CESD ( P = .022 ) , hot flash severity ( P = .006 ) , hot flash frequency ( P = .011 ) , the HFRDI ( P = .014 ) , and NSABP menopausal symptoms ( P = .022 ) ; scores in the SA arm improved significantly on the EuroQol ( P = .022 ) , the HFRDI ( P = .043 ) , and NSABP menopausal symptoms ( P = .005 ) .
RESULTS	Post-hoc analysis indicated that African American patients ( n = 9 ) benefited more from RA than SA compared with non-African American patients ( n = 38 ) in reducing hot flash severity ( P < .001 ) and frequency ( P < .001 ) scores .
CONCLUSIONS	Both RA and SA were associated with improvement in PROs among patients with breast cancer who were receiving AIs , and no significant difference was detected between arms .
CONCLUSIONS	Racial differences in response to acupuncture warrant further study .

###25148243
OBJECTIVE	To evaluate the effect of atomoxetine treatment on executive functions in young adults with attention-deficit/hyperactivity disorder ( ADHD ) .
METHODS	In this Phase 4 , multi-center , double-blind , placebo-controlled trial , young adults ( 18-30 years ) with ADHD were randomized to receive atomoxetine ( 20-50 mg BID , N = 220 ) or placebo ( N = 225 ) for 12 weeks .
METHODS	The Behavior Rating Inventory of Executive Function-Adult ( BRIEF-A ) consists of 75 self-report items within 9 nonoverlapping clinical scales measuring various aspects of executive functioning .
METHODS	Mean changes from baseline to 12-week endpoint on the BRIEF-A were analyzed using an ANCOVA model ( terms : baseline score , treatment , and investigator ) .
RESULTS	At baseline , there were no significant treatment group differences in the percentage of patients with BRIEF-A composite or index T-scores 60 ( p > .5 ) , with over 92 % of patients having composite scores 60 ( 60 deemed clinically meaningful for these analyses ) .
RESULTS	At endpoint , statistically significantly greater mean reductions were seen in the atomoxetine versus placebo group for the BRIEF-A Global Executive Composite ( GEC ) , Behavioral Regulation Index ( BRI ) , and Metacognitive Index ( MI ) scores , as well as the Inhibit , Self-Monitor , Working Memory , Plan/Organize and Task Monitor subscale scores ( p < .05 ) , with decreases in scores signifying improvements in executive functioning .
RESULTS	Changes in the BRIEF-A Initiate ( p = .051 ) , Organization of Materials ( p = .051 ) , Shift ( p = .090 ) , and Emotional Control ( p = .219 ) subscale scores were not statistically significant .
RESULTS	In addition , the validity scales : Inconsistency ( p = .644 ) , Infrequency ( p = .097 ) , and Negativity ( p = .456 ) were not statistically significant , showing scale validity .
CONCLUSIONS	Statistically significantly greater improvement in executive function was observed in young adults with ADHD in the atomoxetine versus placebo group as measured by changes in the BRIEF-A scales .
BACKGROUND	ClinicalTrials.gov NCT00510276 .

###25066510
BACKGROUND	In the general population , the epidemiological relationships between delirium and adverse outcomes are not well defined .
BACKGROUND	The aims of this study were to : ( 1 ) construct an algorithm for the diagnosis of delirium using the Geriatric Mental State ( GMS ) examination ; ( 2 ) test the criterion validity of this algorithm against mortality and dementia risk ; ( 3 ) report the age-specific prevalence of delirium as determined by this algorithm .
METHODS	Participant and informant data in a randomly weighted subsample of the Cognitive Function and Ageing Study were taken from a standardized assessment battery .
METHODS	The algorithmic definition of delirium was based on the DSM-IV classification .
METHODS	Outcomes were : proportional hazard ratios for death ; odds ratios of dementia at 2-year follow-up .
RESULTS	Data from 2197 persons ( representative of 13,004 ) were used , median age 77 years , 64 % women .
RESULTS	Study-defined delirium was associated with a new dementia diagnosis at two years ( OR 8.82 , 95 % CI 2.76 to 28.2 ) and death ( HR 1.28 , 95 % CI 1.03 to 1.60 ) , even after adjustment for acute illness severity .
RESULTS	Similar associations were seen for study-defined subsyndromal delirium .
RESULTS	Age-specific prevalence as determined by the algorithm increased with age from 1.8 % in the 65-69 year age group to 10.1 % in the 85 age group ( p < 0.01 for trend ) .
RESULTS	For study-defined subsyndromal delirium , age-specific period prevalence ranged from 8.2 % ( 65-69 years ) to 36.1 % ( 85 years ) .
CONCLUSIONS	These results demonstrate the possibility of constructing an algorithmic diagnosis for study-defined delirium using data from the GMS schedule , with predictive criterion validity for mortality and dementia risk .
CONCLUSIONS	These are the first population-based analyses able to account prospectively for both illness severity and an earlier study diagnosis of dementia .

###24655729
BACKGROUND	Secondary progressive multiple sclerosis , for which no satisfactory treatment presently exists , accounts for most of the disability in patients with multiple sclerosis .
BACKGROUND	Simvastatin , which is widely used for treatment of vascular disease , with its excellent safety profile , has immunomodulatory and neuroprotective properties that could make it an appealing candidate drug for patients with secondary progressive multiple sclerosis .
METHODS	We undertook a double-blind , controlled trial between Jan 28 , 2008 , and Nov 4 , 2011 , at three neuroscience centres in the UK .
METHODS	Patients aged 18-65 years with secondary progressive multiple sclerosis were randomly assigned ( 1:1 ) , by a centralised web-based service with a block size of eight , to receive either 80 mg of simvastatin or placebo .
METHODS	Patients , treating physicians , and outcome assessors were masked to treatment allocation .
METHODS	The primary outcome was the annualised rate of whole-brain atrophy measured from serial volumetric MRI .
METHODS	Analyses were by intention to treat and per protocol .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00647348 .
RESULTS	140 participants were randomly assigned to receive either simvastatin ( n = 70 ) or placebo ( n = 70 ) .
RESULTS	The mean annualised atrophy rate was significantly lower in patients in the simvastatin group ( 0288 % per year [ SD 0521 ] ) than in those in the placebo group ( 0584 % per year [ 0498 ] ) .
RESULTS	The adjusted difference in atrophy rate between groups was -0254 % per year ( 95 % CI -0422 to -0087 ; p = 0003 ) ; a 43 % reduction in annualised rate .
RESULTS	Simvastatin was well tolerated , with no differences between the placebo and simvastatin groups in proportions of participants who had serious adverse events ( 14 [ 20 % ] vs nine [ 13 % ] ) .
CONCLUSIONS	High-dose simvastatin reduced the annualised rate of whole-brain atrophy compared with placebo , and was well tolerated and safe .
CONCLUSIONS	These results support the advancement of this treatment to phase 3 testing .
BACKGROUND	The Moulton Foundation [ charity number 1109891 ] , Berkeley Foundation [ 268369 ] , the Multiple Sclerosis Trials Collaboration [ 1113598 ] , the Rosetrees Trust [ 298582 ] and a personal contribution from A Pidgley , UK National Institute of Health Research ( NIHR ) University College London Hospitals/UCL Biomedical Research Centres funding scheme .

###24725374
BACKGROUND	Housing First has become a popular treatment model for homeless adults with mental illness , yet little is known about program participants ' early experiences or trajectories .
BACKGROUND	This study used a mixed methods design to examine participant changes in selected domains 6 months after enrollment in a Canadian field trial of Housing First .
METHODS	The study sample included 301 participants receiving the Housing First intervention at the Toronto site of the At Home/Chez Soi project .
METHODS	This study used a pre-post design to compare quantitative 6-month outcome data to baseline values in key domains and multivariate regression to identify baseline demographic , clinical or service use variables associated with observed changes in these domains .
METHODS	In addition , qualitative data exploring participant and service provider perspectives and experiences was collected via stakeholder interviews and focus groups , and analyzed using thematic analysis .
RESULTS	The majority ( 60 to 72 % ) of participants followed the expected trajectory of improvement , with the remaining experiencing difficulties in community integration , mental health symptom severity , substance use , community functioning and quality of life 6 months after program enrollment .
RESULTS	Diagnosis of psychotic disorder was associated with a reduction in quality of life from baseline to 6-months , while substance use disorders were associated with reduced mental illness symptoms and substance use related problems and an improvement in quality of life .
RESULTS	Participants housed in independent housing at 6-months had greater improvements in community integration and quality of life , and greater reduction in mental illness symptoms , compared to those not independently housed .
RESULTS	The quality of the working alliance was positively associated with improvements in physical and psychological community integration and quality of life .
RESULTS	Qualitative data provided a unique window into the loneliness and isolation experienced by Housing First participants , as well as problems related to substance use and a need for life skills training and support .
CONCLUSIONS	Additional strategies can help support Housing First participants in the early stages of program participation and address potential causes of early difficulties , including lack of life skills and social isolation .
CONCLUSIONS	This study highlights the importance of early and ongoing evaluation , monitoring and program adaptations to address consumer support needs .
BACKGROUND	Current Controlled Trials ISRCTN42520374 .

###24641767
BACKGROUND	In the UK around 22 % of men and 24 % of women are obese , and there are varying but worrying levels in other European countries .
BACKGROUND	Obesity is a chronic condition that carries an important health risk .
BACKGROUND	National guidelines , for use in England , on the management of people who are overweight or obese have been published by the National Institute for Health and Clinical Excellence ( NICE , 2006 ) .
BACKGROUND	NICE recommendations for primary care teams are : determine the degree of overweight and obesity ; assess lifestyle , comorbidities and willingness to change ; offer multicomponent management of overweight and obesity ; referral to external services when appropriate .
BACKGROUND	This study investigates a tailored intervention to improve the implementation of these recommendations by primary care teams .
METHODS	The study is a cluster randomised controlled trial .
METHODS	Primary care teams will be recruited from the East Midlands of England , and randomised into two study arms : 1 ) the study group , in which primary care teams are offered a set of tailored interventions to help implement the NICE guidelines for overweight and obesity ; or 2 ) the control group in which primary care teams continue to practice usual care .
METHODS	The primary outcome is the proportion of overweight or obese patients for whom the primary care team adheres to the NICE guidelines .
METHODS	Secondary outcomes include the proportion of patients with a record of lifestyle assessment , referral to external weight loss services , the proportion of obese patients who lose weight during the intervention period , and the mean weight change over the same period .
CONCLUSIONS	Although often recommended , the methods of tailoring implementation interventions to account for the determinants of practice are not well developed .
CONCLUSIONS	This study is part of a programme of studies seeking to develop the methods of tailored implementation .
BACKGROUND	Current Controlled Trials ISRCTN07457585 .
BACKGROUND	Registered 09/08/2013 .
BACKGROUND	Randomisation commenced 30/08/2013 .

###25049330
OBJECTIVE	A multicenter , randomized phase II trial , RECORD-3 , was conducted to compare first-line everolimus followed by sunitinib at progression with the standard sequence of first-line sunitinib followed by everolimus in patients with metastatic renal cell carcinoma .
METHODS	RECORD-3 used a crossover treatment design .
METHODS	The primary objective was to assess progression-free survival ( PFS ) noninferiority of first-line everolimus compared with first-line sunitinib .
METHODS	Secondary end points included combined PFS for each sequence , overall survival ( OS ) , and safety .
RESULTS	Of 471 enrolled patients , 238 were randomly assigned to first-line everolimus followed by sunitinib , and 233 were randomly assigned to first-line sunitinib followed by everolimus .
RESULTS	The primary end point was not met ; the median PFS was 7.9 months for first-line everolimus and 10.7 months for first-line sunitinib ( hazard ratio [ HR ] , 1.4 ; 95 % CI , 1.2 to 1.8 ) .
RESULTS	Among patients who discontinued first-line , 108 ( 45 % ) crossed over from everolimus to second-line sunitinib , and 99 ( 43 % ) crossed over from sunitinib to second-line everolimus .
RESULTS	The median combined PFS was 21.1 months for sequential everolimus then sunitinib and was 25.8 months for sequential sunitinib then everolimus ( HR , 1.3 ; 95 % CI , 0.9 to 1.7 ) .
RESULTS	The median OS was 22.4 months for sequential everolimus and then sunitinib and 32.0 months for sequential sunitinib and then everolimus ( HR , 1.2 ; 95 % CI , 0.9 to 1.6 ) .
RESULTS	Common treatment-emergent adverse events during first-line everolimus or sunitinib were stomatitis ( 53 % and 57 % , respectively ) , fatigue ( 45 % and 51 % , respectively ) , and diarrhea ( 38 % and 57 % , respectively ) .
CONCLUSIONS	Everolimus did not demonstrate noninferiority compared with sunitinib as a first-line therapy .
CONCLUSIONS	The trial results support the standard treatment paradigm of first-line sunitinib followed by everolimus at progression .

###24393351
OBJECTIVE	To report the refractive , topographic , and clinical outcomes 3 years after corneal collagen cross-linking ( CXL ) in eyes with progressive keratoconus .
METHODS	Prospective , randomized controlled trial .
METHODS	One hundred eyes with progressive keratoconus were randomized into the CXL treatment or control groups .
METHODS	Cross-linking was performed by instilling riboflavin 0.1 % solution containing 20 % dextran for 15 minutes before and during the 30 minutes of ultraviolet A irradiation ( 3 mW/cm ( 2 ) ) .
METHODS	Follow-up examinations were arranged at 3 , 6 , 12 , 24 , and 36 months .
METHODS	The primary outcome measure was the maximum simulated keratometry value ( Kmax ) .
METHODS	Other outcome measures were uncorrected visual acuity ( UCVA ; measured in logarithm of the minimum angle of resolution [ logMAR ] units ) , best spectacle-corrected visual acuity ( BSCVA ; measured in logMAR units ) , sphere and cylinder on subjective refraction , spherical equivalent , minimum simulated keratometry value , corneal thickness at the thinnest point , endothelial cell density , and intraocular pressure .
RESULTS	The results from 48 control and 46 treated eyes are reported .
RESULTS	In control eyes , Kmax increased by a mean of 1.200.28 diopters ( D ) , 1.700.36 D , and 1.750.38 D at 12 , 24 , and 36 months , respectively ( all P < 0.001 ) .
RESULTS	In treated eyes , Kmax flattened by-0 .720.15 D,-0 .960.16 D , and-1 .030.19 D at 12 , 24 , and 36 months , respectively ( all P < 0.001 ) .
RESULTS	The mean change in UCVA in the control group was +0.100.04 logMAR ( P = 0.034 ) at 36 months .
RESULTS	In the treatment group , both UCVA ( -0.150.06 logMAR ; P = 0.009 ) and BSCVA ( -0.090.03 logMAR ; P = 0.006 ) improved at 36 months .
RESULTS	There was a significant reduction in corneal thickness measured using computerized videokeratography in both groups at 36 months ( control group : -17.013.63 m , P < 0.001 ; treatment group : -19.525.06 m , P < 0.001 ) that was not observed in the treatment group using the manual pachymeter ( treatment group : +5.864.30 m , P = 0.181 ) .
RESULTS	The manifest cylinder increased by 1.170.49 D ( P = 0.020 ) in the control group at 36 months .
RESULTS	There were 2 eyes with minor complications that did not affect the final visual acuity .
CONCLUSIONS	At 36 months , there was a sustained improvement in Kmax , UCVA , and BSCVA after CXL , whereas eyes in the control group demonstrated further progression .

###26121696
BACKGROUND	Ready-to-use therapeutic food ( RUTF ) has been found effective in treating severe acute malnutrition .
BACKGROUND	Vietnam 's National Institute of Nutrition ( NIN ) , the Institut de Recherche pour le Dveloppement ( IRD ) , and UNICEF collaborated to formulate a local RUTF called High-Energy Bar for Integrated Management of Acute Malnutrition ( HEBI ) .
BACKGROUND	RUTF might be useful to address malnutrition in HIV patients .
OBJECTIVE	To compare the acceptability of the local RUTF and an imported RUTF among malnourished people with HIV in Vietnam Methods : The acceptability of HEBI and Plumpy'Nut was studied among 80 HIV-positive children and 80 HIV-positive adults .
OBJECTIVE	In a crossover design , participants were randomly assigned to receive either Plumpy'Nut or HEBI for 2 weeks and were switched to the other product for the subsequent 2 weeks .
OBJECTIVE	A third ( control ) group of about 40 HIV-positive participants in each study was randomly assigned to receive no RUTF .
OBJECTIVE	Nurses took anthropometric measurements weekly , and the subjects or their caregivers monitored daily RUTF intake .
RESULTS	Children consumed 69 % of HEBI and 65 % of Plumpy'Nut ( p = .13 ) .
RESULTS	Adults consumed 91 % of HEBI and 81 % of Plumpy'Nut ( p = .059 ) .
RESULTS	Both children ( p = .058 ) and adults ( p .0001 ) preferred HEBI .
RESULTS	Significant gains were observed in percent weight ( p = .035 ) , weight-for-age ( p = .014 ) , and body mass index ( BMI ) - for-age ( p = .036 ) in children who received RUTF and in percent weight ( p = .017 ) and BMI ( p = .0048 ) in adults who received RUTF compared with the control groups .
CONCLUSIONS	In this study in Vietnam , both HEBI and Plumpy'Nut were found acceptable by people with HIV .

###24829362
OBJECTIVE	High-sensitivity cardiac troponin I ( cTnI ) assays hold promise in detecting the transition from hypertrophy to heart failure in aortic stenosis .
OBJECTIVE	We sought to investigate the mechanism for troponin release in patients with aortic stenosis and whether plasma cTnI concentrations are associated with long-term outcome .
RESULTS	Plasma cTnI concentrations were measured in two patient cohorts using a high-sensitivity assay .
RESULTS	First , in the Mechanism Cohort , 122 patients with aortic stenosis ( median age 71 , 67 % male , aortic valve area 1.0 0.4 cm ( 2 ) ) underwent cardiovascular magnetic resonance and echocardiography to assess left ventricular ( LV ) myocardial mass , function , and fibrosis .
RESULTS	The indexed LV mass and measures of replacement fibrosis ( late gadolinium enhancement ) were associated with cTnI concentrations independent of age , sex , coronary artery disease , aortic stenosis severity , and diastolic function .
RESULTS	In the separate Outcome Cohort , 131 patients originally recruited into the Scottish Aortic Stenosis and Lipid Lowering Trial , Impact of REgression ( SALTIRE ) study , had long-term follow-up for the occurrence of aortic valve replacement ( AVR ) and cardiovascular deaths .
RESULTS	Over a median follow-up of 10.6 years ( 1178 patient-years ) , 24 patients died from a cardiovascular cause and 60 patients had an AVR .
RESULTS	Plasma cTnI concentrations were associated with AVR or cardiovascular death HR 1.77 ( 95 % CI , 1.22 to 2.55 ) independent of age , sex , systolic ejection fraction , and aortic stenosis severity .
CONCLUSIONS	In patients with aortic stenosis , plasma cTnI concentration is associated with advanced hypertrophy and replacement myocardial fibrosis as well as AVR or cardiovascular death .

###24255991
BACKGROUND	The combination of seawater baths and narrowband ultraviolet B ( NB-UVB ) is a known treatment for psoriasis .
BACKGROUND	This study evaluates two treatment regimens that combine bathing in geothermal seawater and NB-UVB therapy in comparison with NB-UVB monotherapy .
METHODS	Sixty-eight psoriasis patients were randomly assigned to outpatient bathing in geothermal seawater combined with NB-UVB therapy three times a week , intensive daily treatment involving bathing in geothermal seawater combined with NB-UVB therapy , or NB-UVB therapy alone three times a week ; treatment period was 6 weeks .
METHODS	Disease severity [ Psoriasis Area Severity Index ( PASI ) and Lattice System Physician 's Global Assessment scores ] , quality of life ( Dermatology Life Quality Index ) and histological changes were evaluated before , during and after treatment .
METHODS	The primary end point was the proportion of patients who achieved PASI 75 at 6 weeks .
RESULTS	At 6 weeks , the percentage of patients who achieved PASI 75 and PASI 90 was significantly greater for both regimens , bathing in geothermal seawater three times a week ( 68.1 % and 18.2 % , respectively ) and intensive treatment with geothermal seawater ( 73.1 % and 42.3 % , respectively ) than for NB-UVB monotherapy ( 16.7 % and 0 % , respectively ) ( P < 0.05 in all comparisons ) .
RESULTS	Clinical improvement was paralleled by improvement in quality of life and histological score and a reduction in NB-UVB doses .
CONCLUSIONS	Bathing in geothermal seawater combined with NB-UVB therapy in psoriasis induces faster clinical and histological improvement , produces longer remission time and permits lower NB-UVB doses than UVB therapy alone .

###25226273
OBJECTIVE	n-3 polyunsaturated fatty acids ( contained in fish oil ) have been shown to beneficially influence infection rate and clinical outcomes in surgical patients probably due to their immunomodulatory action .
OBJECTIVE	In contrast , study results of fish oil administration in critically ill patients are controversial .
OBJECTIVE	The aim of this study was to investigate the effects of n-3 polyunsaturated fatty acids on the prevalence of nosocomial infections and clinical outcomes in medical and surgical critically ill patients .
METHODS	Prospective , multicenter , randomized , comparative , double-blind study .
METHODS	Seventeen Spanish ICUs during 4 years .
METHODS	A total of 159 medical and surgical intensive care patients with Acute Physiology and Chronic Health Evaluation II score more than or equal to 13 , expected to require total parenteral nutrition for at least 5 days .
METHODS	Patients received total parenteral nutrition prepared either with a lipid emulsion containing 10 % fish oil or a fish oil-free lipid emulsion .
METHODS	The prevalence of nosocomial infections was detected during 28 days of ICU stay .
METHODS	Patients were followed 6 months after discharge from the ICU for length of hospital stay , hospital mortality , and 6-month mortality .
RESULTS	The number of patients with nosocomial infections was significantly reduced in the fish oil-receiving group ( 21.0 % vs 37.2 % , p = 0.035 ) and the predicted time free of infection was prolonged ( 21 2 vs 16 2 d , p = 0.03 ) .
RESULTS	No significant differences were detected for ICU , hospital , and 6-month mortality .
CONCLUSIONS	The results show that administration of n-3 polyunsaturated fatty acids reduces the risk of nosocomial infections and increases the predicted time free of infections in critically ill medical and surgical patients .
CONCLUSIONS	The administration of n-3 polyunsaturated fatty acids was safe and well tolerated .

###25855898
OBJECTIVE	The recent withdrawal of a targeted sepsis therapy has diminished pharmaceutical enthusiasm for developing novel drugs for the treatment of sepsis .
OBJECTIVE	Angiopoietin-2 is an endothelial-derived protein that potentiates vascular inflammation and leakage and may be involved in sepsis pathogenesis .
OBJECTIVE	We screened approved compounds for putative inhibitors of angiopoietin-2 production and investigated underlying molecular mechanisms .
METHODS	Laboratory and animal research plus prospective placebo-controlled randomized controlled trial ( NCT00529139 ) and retrospective analysis ( NCT00676897 ) .
METHODS	Research laboratories of Hannover Medical School and Harvard Medical School .
METHODS	Septic patients/C57Bl/6 mice and human endothelial cells .
METHODS	Food and Drug Administration-approved library screening .
RESULTS	In a cell-based screen of more than 650 Food and Drug Administration-approved compounds , we identified multiple members of the 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor drug class ( referred to as statins ) that suppressed angiopoietin-2 .
RESULTS	Simvastatin inhibited 3-hydroxy-3-methyl-glutaryl-CoA reductase , which in turn activated PI3K-kinase .
RESULTS	Downstream of this signaling , PI3K-dependent phosphorylation of the transcription factor Foxo1 at key amino acids inhibited its ability to shuttle to the nucleus and bind cis-elements in the angiopoietin-2 promoter .
RESULTS	In septic mice , transient inhibition of angiopoietin-2 expression by liposomal siRNA in vivo improved absolute survival by 50 % .
RESULTS	Simvastatin had a similar effect , but the combination of angiopoietin-2 siRNA and simvastatin showed no additive benefit .
RESULTS	To verify the link between statins and angiopoietin-2 in humans , we performed a pilot matched case-control study and a small randomized placebo-controlled trial demonstrating beneficial effects on angiopoietin-2 .
CONCLUSIONS	3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitors may operate through a novel Foxo1-angiopoietin-2 mechanism to suppress de novo production of angiopoietin-2 and thereby ameliorate manifestations of sepsis .
CONCLUSIONS	Given angiopoietin-2 's dual role as a biomarker and candidate disease mediator , early serum angiopoietin-2 measurement may serve as a stratification tool for future trials of drugs targeting vascular leakage .

###25190226
OBJECTIVE	To evaluate the efficacy and safety of alogliptin added to insulin in Japanese patients with type 2 diabetes mellitus ( T2DM ) who are poorly controlled with insulin and diet or exercise .
METHODS	This was a randomized , double-blind , 12-week comparative trial of alogliptin and insulin versus placebo and insulin in 179 patients with T2DM followed by a 40-week , open-label phase in 169 patients on alogliptin and insulin .
METHODS	Change in glycated hemoglobin ( HbA1c ) from baseline to the end of double-blind phase ( week 12 ) .
RESULTS	The change in HbA1c ( least squares means ) from baseline to week 12 was -0.96 % for the alogliptin and insulin group and -0.29 % for the placebo and insulin group .
RESULTS	The point estimate ( 95 % confidence interval ) intergroup difference was -0.66 % ( [ -0.824 % , -0.503 % ] ) .
RESULTS	In the alogliptin and insulin group , HbA1c started to decrease from week 2 onward and peaked by week 12 .
RESULTS	The proportions of patients who achieved HbA1c < 8.0 , < 7.0 and < 6.0 % at week 12 were significantly higher in alogliptin and insulin group ( 73.0 , 23.3 and 1.1 % ) than in placebo and insulin group ( 25.0 , 5.7 and 0 % ) .
RESULTS	Incidences of adverse effects were comparable between groups , with no relevant increases in hypoglycemia or weight gain seen .
CONCLUSIONS	Alogliptin 25 mg/day was effective and well tolerated when added to insulin in Japanese patients with inadequately controlled T2DM .

###24981149
OBJECTIVE	Fifty percent of pregnancies in the United States are unintended despite numerous contraceptive methods available to women .
OBJECTIVE	The only male contraceptive methods , vasectomy and condoms , are used by 10 % and 16 % of couples , respectively .
OBJECTIVE	Prior studies have shown efficacy of male hormonal contraceptives in development , but few have evaluated patient acceptability and potential use if commercially available .
OBJECTIVE	The objective of this study is to determine if a transdermal gel-based male hormonal contraceptive regimen , containing testosterone and Nestorone gels , would be acceptable to study participants as a primary contraceptive method .
METHODS	As part of a three-arm , 6-month , double-blind , randomized controlled trial of testosterone and nestorone gels at two academic medical centers , subjects completed a questionnaire to assess the acceptability of the regimen .
METHODS	Of the 99 men randomized , 79 provided data for analysis .
RESULTS	Overall , 56 % ( 44/79 ) of men were satisfied or extremely satisfied with this gel-based method of contraception , and 51 % ( 40/79 ) reported that they would recommend this method to others .
RESULTS	One third of subjects ( 26/79 ) reported that they would use this as their primary method of contraception if it were commercially available today .
RESULTS	However , men with concerns about sexually transmitted disease were significantly less satisfied than men without such concerns ( p = 0.03 ) .
CONCLUSIONS	A majority of the men who volunteered to participate in this trial of an experimental male hormonal contraceptive were satisfied with this transdermal male hormonal contraceptive .
CONCLUSIONS	If commercially available , a combination of topical nesterone and testosterone gels could provide a reversible , effective method of contraception that is appealing to men .
CONCLUSIONS	A substantial portion of men report they would use this transdermal male contraceptive regimen if commercially available .
CONCLUSIONS	This method would provide a novel , reversible method of contraception for men , whose current choices are limited to condoms and vasectomy .

###24470182
OBJECTIVE	The current study aimed to investigate the effects of eicosapentaenoic acid ( EPA ) - rich and docosahexaenoic acid ( DHA ) - rich supplementations on cognitive performance and functional brain activation .
METHODS	A double-blind , counterbalanced , crossover design , with a 30-day washout period between two supplementation periods ( EPA-rich and DHA-rich ) was employed .
METHODS	Functional magnetic resonance imaging scans were obtained during performance of Stroop and Spatial Working Memory tasks prior to supplementation and after each 30-day supplementation period .
RESULTS	Both supplementations resulted in reduced ratio of arachidonic acid to EPA levels .
RESULTS	Following the EPA-rich supplementation , there was a reduction in functional activation in the left anterior cingulate cortex and an increase in activation in the right precentral gyrus coupled with a reduction in reaction times on the colour-word Stroop task .
RESULTS	By contrast , the DHA-rich supplementation led to a significant increase in functional activation in the right precentral gyrus during the Stroop and Spatial Working Memory tasks , but there was no change in behavioural performance .
CONCLUSIONS	By extending the theory of neural efficiency to the within-subject neurocognitive effects of supplementation , we concluded that following the EPA-rich supplementation , participants ' brains worked ` less hard ' and achieved a better cognitive performance than prior to supplementation .
CONCLUSIONS	Conversely , the increase in functional activation and lack of improvement in time or accuracy of cognitive performance following DHA-rich supplementation may indicate that DHA-rich supplementation is less effective than EPA-rich supplementation in enhancing neurocognitive functioning after a 30-day supplementation period in the same group of individuals .

###24606836
BACKGROUND	The occurrence of response shift ( RS ) in longitudinal health-related quality of life ( HRQoL ) studies , reflecting patient adaptation to disease , has already been demonstrated .
BACKGROUND	Several methods have been developed to detect the three different types of response shift ( RS ) , i.e. recalibration RS , 2 ) reprioritization RS , and 3 ) reconceptualization RS .
BACKGROUND	We investigated two complementary methods that characterize the occurrence of RS : factor analysis , comprising Principal Component Analysis ( PCA ) and Multiple Correspondence Analysis ( MCA ) , and a method of Item Response Theory ( IRT ) .
METHODS	Breast cancer patients ( n = 381 ) completed the EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires at baseline , immediately following surgery , and three and six months after surgery , according to the `` then-test/post-test '' design .
METHODS	Recalibration was explored using MCA and a model of IRT , called the Linear Logistic Model with Relaxed Assumptions ( LLRA ) using the then-test method .
METHODS	Principal Component Analysis ( PCA ) was used to explore reconceptualization and reprioritization .
RESULTS	MCA highlighted the main profiles of recalibration : patients with high HRQoL level report a slightly worse HRQoL level retrospectively and vice versa .
RESULTS	The LLRA model indicated a downward or upward recalibration for each dimension .
RESULTS	At six months , the recalibration effect was statistically significant for 11/22 dimensions of the QLQ-C30 and BR23 according to the LLRA model ( p 0.001 ) .
RESULTS	Regarding the QLQ-C30 , PCA indicated a reprioritization of symptom scales and reconceptualization via an increased correlation between functional scales .
CONCLUSIONS	Our findings demonstrate the usefulness of these analyses in characterizing the occurrence of RS .
CONCLUSIONS	MCA and IRT model had convergent results with then-test method to characterize recalibration component of RS .
CONCLUSIONS	PCA is an indirect method in investigating the reprioritization and reconceptualization components of RS .

###24939817
OBJECTIVE	Multidose steroid pretreatment is effective in preventing postextubation airway obstruction ( PEAO ) in adults , however controversy continues for children .
OBJECTIVE	This study was designed as a randomized , placebo-controlled , double-blind trial to compare the effect of 24-h pretreatment with dexamethasone ( 24hPD ) versus 6-h pretreatment ( 6hPD ) on PEAO and reintubation in children at a tertiary care hospital in a developing economy .
METHODS	Hundred twenty-four children ( 3 months to 12 years ) intubated for 48 h and planned to have extubation during next 24 h were randomized to receive 24hPD ( 0.5 mg/kg/dose , q6h , total of six doses ; n = 66 ) or 6hPD ( total of three doses ; n = 58 ) .
METHODS	Patients with preexistent upper airway conditions , chronic respiratory diseases , steroid therapy in last 7 days , gastrointestinal bleeding , hypertension , and hyperglycemia and those likely to have poor airway reflexes were excluded .
RESULTS	The two groups were similar at baseline .
RESULTS	24hPD reduced the incidence of PEAO ( 43/66 versus 48/58 ; p = 0.027 ) with absolute risk reduction of 17 % .
RESULTS	It also reduced the incidence of reintubation , though nonsignificantly , by half [ 5/61 versus 9/58 ; relative risk ( RR ) , 1.09 ; 95 % confidence interval ( CI ) , 0.96-1 .25 ] .
RESULTS	Time to recovery from PEAO among non-reintubated patients was shorter among 24hPD patients ( p = 0.016 ) .
RESULTS	No adverse event was noted with dexamethasone use .
RESULTS	Intubation duration > 7 days and cuffed tracheal tubes were found to be independent risk factors for PEAO ( odds ratio 6 and 3.12 , respectively ) .
CONCLUSIONS	24-h pretreatment with multidose dexamethasone reduced the incidence of PEAO and the time to recover from it .
CONCLUSIONS	24hPD should be considered for high-risk children intubated for > 48 h in the study setting .
CONCLUSIONS	Further studies with larger sample size from different socioeconomic background are desirable to validate these findings .

###26222559
BACKGROUND	Apolipoprotein C-III ( APOC3 ) is a key regulator of plasma triglyceride levels .
BACKGROUND	Elevated triglyceride levels are associated with a risk of adverse cardiovascular events and pancreatitis .
BACKGROUND	ISIS 304801 is a second-generation antisense inhibitor of APOC3 synthesis .
METHODS	We conducted a randomized , double-blind , placebo-controlled , dose-ranging , phase 2 study to evaluate ISIS 304801 in untreated patients with fasting triglyceride levels between 350 mg per deciliter ( 4.0 mmol per liter ) and 2000 mg per deciliter ( 22.6 mmol per liter ) ( ISIS 304801 monotherapy cohort ) , as well as in patients receiving stable fibrate therapy who had fasting triglyceride levels between 225 mg per deciliter ( 2.5 mmol per liter ) and 2000 mg per deciliter ( ISIS 304801-fibrate cohort ) .
METHODS	Eligible patients were randomly assigned to receive either ISIS 304801 , at doses ranging from 100 to 300 mg , or placebo , once weekly for 13 weeks .
METHODS	The primary outcome was the percentage change in APOC3 level from baseline .
RESULTS	A total of 57 patients were treated in the ISIS 304801 monotherapy cohort ( 41 received active agent , and 16 received placebo ) , and 28 patients were treated in the ISIS 304801-fibrate cohort ( 20 received active agent , and 8 received placebo ) .
RESULTS	The mean ( SD ) baseline triglyceride levels in the two cohorts were 581291 mg per deciliter ( 6.63.3 mmol per liter ) and 376188 mg per deciliter ( 4.22.1 mmol per liter ) , respectively .
RESULTS	Treatment with ISIS 304801 resulted in dose-dependent and prolonged decreases in plasma APOC3 levels when the drug was administered as a single agent ( decreases of 40.032.0 % in the 100-mg group , 63.822.3 % in the 200-mg group , and 79.69.3 % in the 300-mg group , vs. an increase of 4.241.7 % in the placebo group ) and when it was administered as an add-on to fibrates ( decreases of 60.212.5 % in the 200-mg group and 70.913.0 % in the 300-mg group , vs. a decrease of 2.225.2 % in the placebo group ) .
RESULTS	Concordant reductions of 31.3 to 70.9 % were observed in triglyceride levels .
RESULTS	No safety concerns were identified in this short-term study .
CONCLUSIONS	We found that treatment with ISIS 304801 was associated with significant lowering of triglyceride levels , among patients with a broad range of baseline levels , through selective antisense inhibition of APOC3 synthesis .
CONCLUSIONS	( Funded by Isis Pharmaceuticals ; ClinicalTrials.gov number , NCT01529424 . )

###25335434
BACKGROUND	Intravitreal triamcinolone acetonide ( IVTA ) is an effective treatment for recalcitrant diabetic macular oedema ( DMO ) .
BACKGROUND	It has been shown to improve vision with benefits persisting up to five years .
BACKGROUND	The most common initial side effect of IVTA treatment is rise in intraocular pressure , occurring in approximately 50 % of patients within the first 6 months of treatment .
BACKGROUND	We evaluated whether there is a correlation between the development of intraocular pressure rise and improvement in vision .
METHODS	Analysis of individual data from 33 eyes of 33 participants treated with IVTA for DMO from a prospective , randomised , double-masked , placebo controlled trial .
METHODS	The degree of intraocular pressure ( IOP ) rise was correlated with improvement in best-corrected visual acuity ( BCVA ) at 1 and 6 months .
RESULTS	The proportion of eyes gaining 5 or more logMAR letters was higher in eyes with greater IOP rise ( p = 0.044 ) .
RESULTS	Better absolute improvement in BCVA at 6 months ( p = 0.045 ) was also found in eyes with greater IOP rise .
RESULTS	Regression analyses revealed a correlation between IOP rise of 10 or more mmHg and absolute BCVA improvement at 6 months ( odds ratio 1.22 , 95 % confidence interval 1.01-1 .48 , p = 0.039 ) , but not at 1 month .
CONCLUSIONS	IOP rise and vision improvement appear to be correlated following IVTA for DMO , suggesting that the mechanisms that cause both may be linked .
BACKGROUND	Clinical trials.gov NCT00167518 , September 5 , 2005 .

###24438360
BACKGROUND	During continuous venovenous haemofiltration ( CVVH ) , regional anticoagulation with citrate may be superior to heparin in terms of biocompatibility , since heparin as opposed to citrate may activate complement ( reflected by circulating C5a ) and induce neutrophil degranulation in the filter and myeloperoxidase ( MPO ) release from endothelium .
METHODS	No anticoagulation ( n = 13 ) , unfractionated heparin ( n = 8 ) and trisodium citrate ( n = 17 ) regimens during CVVH were compared .
METHODS	Blood samples were collected pre - and postfilter ; C5a , elastase and MPO were determined by ELISA .
METHODS	Additionally , C5a was also measured in the ultrafiltrate .
RESULTS	In the heparin group , there was C5a production across the filter which most decreased over time as compared to other groups ( P = 0.007 ) .
RESULTS	There was also net production of elastase and MPO across the filter during heparin anticoagulation ( P = 0.049 or lower ) , while production was minimal and absent in the no anticoagulation and citrate group , respectively .
RESULTS	During heparin anticoagulation , plasma concentrations of MPO at the inlet increased in the first 10 minutes of CVVH ( P = 0.024 ) .
CONCLUSIONS	Citrate confers less filter-induced , potentially harmful complement activation and neutrophil degranulation and less endothelial activation than heparin when used for anticoagulation during continuous venovenous haemofiltration in critically ill patients .

###24270933
METHODS	Prospective , single-blinded , and randomized clinical trial .
OBJECTIVE	This study evaluates the added benefit of promethazine administration as an anxiolytic adjunct to morphine analgesia in reducing acute low back pain ( LBP ) compared with morphine alone .
BACKGROUND	Acute LBP is one of the most common reasons for emergency department ( ED ) visits .
BACKGROUND	The optimal analgesic treatment for acute LBP remains controversial .
BACKGROUND	Anxiety relief has been shown to improve pain management in the ED setting .
BACKGROUND	We hypothesized that administration of the antihistamine promethazine as an anxiolytic adjunct to morphine analgesia will improve LBP management compared with morphine alone .
METHODS	Fifty-nine adults , who were treated in our ED for severe acute LBP ( visual analogue scale 70 mm ) , were randomly enrolled in the study .
METHODS	Thirty patients received slow infusion of intravenous ( IV ) morphine 0.1 mg/kg in normal saline and 29 patients received an analgesic regimen of IV morphine 0.1 mg/kg with promethazine 25 mg administered similarly .
METHODS	Pain and anxiety levels were subjectively assessed by the patients on a 100-mm visual analogue scale before and after treatment .
METHODS	Adverse event related to analgesia were recorded in real time .
RESULTS	After analgesia administration patients ' pain rating decreased by 43 mm in the morphine group and by 39 mm in the morphine/promethazine group ( P = 0.26 ) .
RESULTS	Similarly , patients ' anxiety decreased by 19 mm in the morphine group and by 13 mm in the morphine/promethazine group ( P = 0.37 ) .
RESULTS	The average ED stay was 78 minutes longer in the morphine/promethazine group ( P = 0.01 ) , due to the strong sedative effect of promethazine .
RESULTS	Patients ' satisfaction and the rate of adverse events were similar in both groups .
CONCLUSIONS	IV administration of morphine-promethazine regimen for pain and anxiety relief associated with acute LBP showed no advantage compared with IV morphine alone and significantly lengthened the overall ED stay .
CONCLUSIONS	Thus , we think that promethazine has no place in acute LBP management in the adult ED setting .
METHODS	1 .

###25134291
OBJECTIVE	To evaluate the long-term effectiveness of presurgical therapy with GnRH analogues in patients who underwenthydrothermal endometrial ablation ( HTA ) for menorrhagia and assess the relationship between sonographically measured myometrium thickness and pelvic pain .
METHODS	A prospective randomized control study comparing 15 women ( Group A ) with presurgical subcutaneous triptorelin depot injection before HTA with controls ( Group B , n = 15 ) .
METHODS	Inclusion criteria were : recurrent menorrhagia , uterus length < 12 cm , no previous hormonal therapy for at least six month , and family plan completed .
METHODS	Student 's t test was applied , as appropriate , to compare continuous variables .
METHODS	Proportion were compared with chi-squared .
RESULTS	After 12 months of follow-up , Group A showed a significantly lower ( 0 % vs 20 % ; p = 0.03 ) failure rate after hydrothermoablation than the Group B and a generally higher successful rate at 24 and 48 months .
RESULTS	The discomfort , evaluated with VAS , showed a mean value of 47.6 + / - 15.9 + / - SD ) ; 96.7 % of women reported a mild-moderate postoperative pain .
RESULTS	No perioperative and late complications were recorded .
CONCLUSIONS	Presurgical treatment with GnRH analogues seems to improve long-term efficacy of HTA .
CONCLUSIONS	Perioperative pelvic pain seems to not be affected by myometrium thickness .

###25226881
OBJECTIVE	Data are inconsistent regarding the associations between age , age at diagnosis of diabetes , diabetes duration and subsequent vascular complications .
METHODS	The associations between age ( or age at diagnosis ) , diabetes duration and major macrovascular events , all-cause death and major microvascular events were examined in 11,140 patients with type 2 diabetes randomly allocated to intensive or standard glucose control in the Action in Diabetes and Vascular Disease : Preterax and Diamicron Modified Release Controlled Evaluation ( ADVANCE ) trial .
METHODS	Rates were calculated by 5 year baseline age ( or age at diagnosis ) and diabetes duration strata .
METHODS	Risks were estimated using Cox models adjusted for treatment assignment and HbA1c .
RESULTS	The mean age ( SD ) was 65.86.4 years , age at diagnosis was 57.88.7 years and diabetes duration was 7.96.4 years .
RESULTS	Diabetes duration was associated with the risk of macrovascular events ( HR 1.13 [ 95 % CI 1.08 , 1.17 ] ) , microvascular events ( 1.28 [ 1.23 , 1.33 ] ) and death ( 1.15 [ 1.10 , 1.20 ] ) whereas age ( or age at diagnosis ) was only associated with the risk of macrovascular events ( 1.33 [ 1.27 , 1.39 ] ) and death ( 1.56 [ 1.48 , 1.64 ] ) .
RESULTS	No interaction was observed between diabetes duration , age and the risk of macrovascular events or death ( both p > 0.4 ) .
RESULTS	However , an interaction was observed between diabetes duration , age and the risk of microvascular events ( p = 0.002 ) , such that the effects of increasing diabetes duration were greatest at younger rather than older age .
CONCLUSIONS	In patients with type 2 diabetes , age or age at diagnosis and diabetes duration are independently associated with macrovascular events and death whereas only diabetes duration is independently associated with microvascular events and this effect is greater in the youngest patients .

###26094328
BACKGROUND	Electrotherapy , including theTENS and interferential current ( IFC ) is one of the most frequently used treatments in physical therapy in patients with low back pain .
BACKGROUND	The aim of this study was to assess the influence of TENS and IFC on pain relief and to compare the analgesic efficacy of the two currents .
METHODS	Sixty patients aged 53.5 12.5 , with low back pain , were randomly divided into two groups : IFC ( gr .
METHODS	I ) and TENS ( gr .
METHODS	II ) .
METHODS	Depending on the groups , patients were given series of ten 20-minute sessions using either IF orTENS currents .
METHODS	In all patients VAS and Laitinen modified scale were taken before and after treatment .
RESULTS	After 2-weeks therapy there was improvement in the VAS and Laitinen scale ( all components ) in both groups , except for the part of the Laitinen scale on the reduction of activity in the group II ( TENS ) .
RESULTS	There was no statistically significant difference between the TENS and IF groups in reducing the intensity and other aspects of pain ( frequency , pain medication and activity limitation ) under the influence of therapy ( p > 0.05 ) .
CONCLUSIONS	Interferential current and TENS therapy are effective for pain relief in patients with low back pain .
CONCLUSIONS	The study showed equal analgesic efficacy of both treatments .

###25607558
BACKGROUND	Limited options are available for the treatment of brittle nail syndrome .
OBJECTIVE	To assess the efficacy and safety of topical cyclosporine emulsion ( CsAE ) versus emulsion ( vehicle ) alone in the treatment of brittle nail syndrome .
RESULTS	Twenty-four patients were randomized to topical CsAE emulsion or emulsion ( vehicle ) for 24 weeks .
RESULTS	Four fingernails of each patient were included ; the 2 most severe brittle nails and the second most normal nail were treated with the same medication .
RESULTS	The fourth nail , the most normal nail , remained untreated and was used to assess nail growth .
RESULTS	The prespecified primary endpoint was change from baseline in Physician Global Assessment ( PGA ) score ( 0 to 5 scale ) at each follow-up visit .
RESULTS	Safety evaluations were conducted at each visit .
RESULTS	In the intent-to-treat population ( n = 12 for each treatment arm ) , the PGA score for treated nails improved from baseline ( CsAE , 0.7 to 1.4 ; emulsion , 0.7 to 1.5 ; P < 0.05 for each ) , with no significant between-group differences .
RESULTS	Untreated nails did not improve in overall appearance ( 0.0 to 0.3 grade ; P > 0.05 ) .
RESULTS	Statistically and clinically significant improvement from baseline was reported for nail length/appearance in both CsAE and vehicle groups .
CONCLUSIONS	Sample size was relatively small .
CONCLUSIONS	The difference in PGA between treated and untreated nails was not analyzed .
CONCLUSIONS	Baseline disease severity may have been too mild , limiting detection of efficacy .
CONCLUSIONS	Both CsAE and emulsion vehicle applied topically appeared to improve signs and symptoms of brittle nail syndrome and were well tolerated .
CONCLUSIONS	These findings warrant corroboration in a larger population and inclusion of comparison with an inactive control and a higher concentration of CsAE , the former which may help in distinguishing the efficacy of vehicle emulsion from CsAE .

###24823465
BACKGROUND	Phosphodiesterase ( PDE ) enzymes , including members of PDE4 , have been investigated in the regulation of endocrine and reproductive functions of ovaries .
BACKGROUND	In addition , selective inhibition of PDE4 enzyme has recently been implicated in the regulation of metabolism with positive effects on glucose homeostasis and weight reduction .
OBJECTIVE	The aim of this study was to evaluate whether the PDE4 inhibitor roflumilast affects body weight and hormonal and metabolic status in obese women with polycystic ovary syndrome ( PCOS ) .
OBJECTIVE	Design/Participants/Main Outcome Measures : A 12-week prospective randomized open-label study was conducted with 36 obese women with PCOS diagnosed by the National Eunice Kennedy Shriver Institute of Child Health and Human Development criteria that had been pretreated with metformin ( MET ) .
OBJECTIVE	They were randomized to MET 1000 mg twice a day or combined treatment ( COM ) with MET 1000 mg twice a day and roflumilast 500 g every day .
OBJECTIVE	The primary outcome was change in anthropometric measures of obesity .
RESULTS	Thirty-one patients ( aged 33.8 7.4 y , twice a day 36.4 5.1 kg/m ( 2 ) , mean SD ) completed the study : 16 on MET and 15 on COM .
RESULTS	Subjects treated with COM lost on average 4.2 2.8 kg compared with a 0.9 2.5 kg weight gain in the MET group ( P = .025 ) .
RESULTS	Body mass index decreased for 1.6 1.1 kg/m ( 2 ) in COM arm compared with increase for 0.9 2.4 kg/m ( 2 ) in the MET arm ( P = .046 ) .
RESULTS	Visceral adipose tissue area as assessed by dual-energy x-ray absorptiometry decreased from 136.7 37.8 to 121.2 36.2 cm ( 2 ) in the COM arm compared with an increase from 155.3 61.9 to 166.7 67.2 cm ( 2 ) in the MET arm ( P = .02 ) .
RESULTS	From baseline to study end , both treatment interventions resulted in a significant reduction of androstenedione ( P = .013 ) , free T ( P = .002 ) , and homeostasis model assessment for insulin resistance score ( P = .027 ) and a significant increase in SHBG ( P = .024 ) , although the between-treatment differences of the changes have not been statistically significant yet .
CONCLUSIONS	Roflumilast added to metformin reduced body weight in obese women with PCOS , primarily due to a loss of fat mass .

###25332474
BACKGROUND	Randomized controlled trials specifically designed to assess inflammation-related outcomes in response to dairy consumption are lacking .
OBJECTIVE	We investigated the impact of dairy food consumption on biomarkers of inflammation in healthy men and women with low-grade systemic inflammation .
METHODS	In a multicenter randomized crossover study , 112 adult men and women with high-sensitivity C-reactive protein ( hs-CRP ) values > 1 mg/L consumed 3 servings/d of dairy ( 375 mL low-fat milk , 175 g low-fat yogurt , and 30 g regular-fat cheddar cheese ) or energy-matched control ( fruit juice , vegetable juice , cashews , and 1 cookie ) products as part of prudent 4-wk diets , each separated by a 4 - to 8-wk washout period .
METHODS	Serum concentrations of inflammation biomarkers were measured at the beginning and end of each dietary phase .
METHODS	Expression levels of key inflammatory genes and transcription factors in whole blood cells were assessed at the end of each diet by real-time polymerase chain reaction in a random subset of 53 subjects .
RESULTS	Analysis of within-diet changes ( post - vs. prediet values ) showed a significant reduction in hs-CRP concentrations after the control diet ( -11.7 % , P = 0.05 ) but no change after the dairy diet ( -7.3 % , P = 0.47 ) .
RESULTS	As a result , changes in hs-CRP differed between the dairy and control diets ( P = 0.04 ) .
RESULTS	Both the control and dairy diets similarly reduced interleukin-6 concentrations compared with diet-specific baseline values ( -17.6 % and -19.9 % , respectively ; P < 0.0001 for both , P = 0.77 for between-diet comparison ) .
RESULTS	No between - or within-diet difference was observed in adiponectin concentrations , and there was also no between-diet difference in the expression of inflammatory genes and transcription factors .
CONCLUSIONS	Consistent with data from previous work , these results suggest that short-term consumption of a combination of low - and high-fat dairy products as part of a healthy diet has no adverse effects on inflammation .
CONCLUSIONS	This trial was registered at www.clinicaltrials.gov as NCT01444326 .

###25926410
BACKGROUND	Hepatic lipase ( HL ) plays a pivotal role in the metabolism of HDL and LDL .
BACKGROUND	Recent genome-wide association studies have identified common variants in the HL gene ( LIPC ) associated with HDL cholesterol .
OBJECTIVE	We tested the effect of a common variant in LIPC on changes in blood lipids in response to weight-loss diets in the Preventing Overweight Using Novel Dietary Strategies Trial .
METHODS	We genotyped LIPC rs2070895 in 743 overweight or obese adults aged 30-70 y ( 61 % women ) who were assigned to high-fat ( 40 % energy ) or low-fat ( 20 % energy ) diets for 2 y.
METHODS	We measured serum concentrations of total cholesterol ( TC ) , triglycerides , LDL cholesterol , and HDL cholesterol at baseline and 2 y of intervention .
RESULTS	At 2 y of intervention , dietary fat modified effects of the variant on changes in serum TC , LDL cholesterol , and HDL cholesterol ( P-interaction : 0.0008 , 0.004 , and 0.03 , respectively ) .
RESULTS	In the low-fat group , as compared to the G allele , the A allele tended to be related to the decrease in TC and LDL cholesterol concentrations [ TC ( SE ) : -5.5 3.0 , P = 0.07 ; LDL cholesterol : -4.8 2.5 , P = 0.06 ] and a lower increase in HDL cholesterol concentrations ( SE : -1.37 0.69 , P = 0.048 ) , whereas an opposite effect in the high-fat diet group was evident [ TC ( SE ) : 7.3 2.7 , P = 0.008 ; LDL cholesterol : 4.1 2.3 , P = 0.07 ] , and there was no genetic effect on changes in HDL cholesterol concentrations ( P = 0.54 ) .
CONCLUSIONS	Dietary fat intake modifies the effect of a common variant in LIPC on changes in serum lipids during a long-term weight-loss intervention in overweight or obese adults .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT00072995 .

###24325057
OBJECTIVE	To explore the clinical efficacy of open-door cervical laminoplasty combined Modified Buyang Huanwu Decoction ( MBHD ) to treat cervical spinal canal stenosis ( CSCS ) .
METHODS	Totally 32 CSCS patients were randomly assigned to two groups , Group A ( 17 cases , treated by laminoplasty ) and Group B ( 15 cases , treated by laminoplasty combined MBHD ) .
METHODS	All patients received open-door cervical laminoplasty .
METHODS	Those in Group B took MBHD additionally for 2 weeks after surgery .
METHODS	The visual analogue scale ( VAS ) , the Japanese Orthopedic Association ( JOA ) score , and the neck disability index ( NDI ) were measured preoperative , postoperative 3 months and 12 months , respectively .
RESULTS	There was no statistical difference in preoperative VAS , JOA , or NDI ( P > 0.05 ) .
RESULTS	The VAS , JOA , and NDI were obviously improved 3 months and 12 months after surgery in the two groups , showing statistical difference when compared with before surgery in the same group ( P < 0.01 ) .
RESULTS	At 3 months after surgery the aforesaid indices in Group B were superior to those in Group A ( P < 0.05 ) .
RESULTS	There was no statistical difference in the aforesaid indices between the two groups at 12 months after surgery ( P > 0.05 ) .
CONCLUSIONS	MBHD favorably improved early recovery of neural functions of CSCS patients ( 3 months after surgery ) .

###25559659
BACKGROUND	Increased levels of reactive oxygen species during and after surgery may affect inflammatory response , post-operative adhesion molecule formation , and hemodynamic stability .
BACKGROUND	The glutathione redox cycle is an important regulator in oxidative stress and its reduced forms scavenge free radicals .
BACKGROUND	N-acetyl cysteine , a precursor of reduced glutathione , is considered as a potentially therapeutic wide spectrum agent in clinical practice .
BACKGROUND	We therefore examined whether N-acetyl cysteine improves some biochemical parameters in cancer patients undergoing major abdominal surgery .
METHODS	Thirty-three patients diagnosed with pancreas , stomach , rectum , colon malignancies , and undergoing major abdominal surgery at Ankara Numune Training and Research Hospital were randomly divided into two groups ; control ( CON ) and N-acetyl cysteine ( NAC ) .
METHODS	The NAC group had 1,200mgN-acetyl cysteine starting two days before the operation day , in addition to isonitrogenous and isocaloric total parenteral nutrition of 1.2 g/kg protein , 25kcal/kg , and 60:40 carbohydrate/fat ratio .
METHODS	Blood and urine samples were drawn two days before the operation , on operation day , and on the first , third , and fifth days post-operation .
RESULTS	Plasma malondialdehyde was significantly lower in the NAC group ( P < 0.001 ) .
RESULTS	N-acetyl cysteine treatment did not affect plasma levels of vitamin A , C or E.
RESULTS	The NAC group exhibited a higher ratio of reduced glutathione to oxidised glutathione ( P = 0.019 ) .
RESULTS	Urinary nitrate level was also significantly lower in the NAC group ( P = 0.016 ) .
CONCLUSIONS	The study demonstrated the clinical importance of N-acetyl cysteine supplementation on antioxidant parameters in abdominal surgery patients .
CONCLUSIONS	In these patients N-acetyl cysteine and vitamin administration can be considered as an effective method for improvement of oxidative status .

###24657003
BACKGROUND	In our randomised , controlled , phase 3 trial NeOAdjuvant Herceptin ( NOAH ) trial in women with HER2-positive locally advanced or inflammatory breast cancer , neoadjuvant trastuzumab significantly improved pathological complete response rate and event-free survival .
BACKGROUND	We report updated results from our primary analysis to establish the long-term benefit of trastuzumab-containing neoadjuvant therapy .
METHODS	We did this multicentre , open-label , randomised trial in women with HER2-positive locally advanced or inflammatory breast cancer .
METHODS	Participants were randomly assigned ( 1:1 ) , by computer program with a minimisation technique , to receive neoadjuvant chemotherapy alone or with 1 year of trastuzumab ( concurrently with neoadjuvant chemotherapy and continued after surgery ) .
METHODS	A parallel group with HER2-negative disease was included and received neoadjuvant chemotherapy alone .
METHODS	Our primary endpoint was event-free survival .
METHODS	Analysis was by intention to treat .
METHODS	This study is registered at www.controlled-trials.com , ISRCTN86043495 .
RESULTS	Between June 20 , 2002 , and Dec 12 , 2005 , we enrolled 235 patients with HER2-positive disease , of whom 118 received chemotherapy alone and 117 received chemotherapy plus trastuzumab .
RESULTS	99 additional patients with HER2-negative disease were included in the parallel cohort .
RESULTS	After a median follow-up of 5.4 years ( IQR 3.1-6 .8 ) the event-free-survival benefit from the addition of trastuzumab to chemotherapy was maintained in patients with HER2-positive disease .
RESULTS	5 year event-free survival was 58 % ( 95 % CI 48-66 ) in patients in the trastuzumab group and 43 % ( 34-52 ) in those in the chemotherapy group ; the unadjusted hazard ratio ( HR ) for event-free survival between the two randomised HER2-positive treatment groups was 0.64 ( 95 % CI 0.44-0 .93 ; two-sided log-rank p = 0.016 ) .
RESULTS	Event-free survival was strongly associated with pathological complete remission in patients given trastuzumab .
RESULTS	Of the 68 patients with a pathological complete response ( 45 with trastuzumab and 23 with chemotherapy alone ) , the HR for event-free survival between those with and without trastuzumab was 0.29 ( 95 % CI 0.11-0 .78 ) .
RESULTS	During follow-up only four cardiovascular adverse events were regarded by the investigator to be drug-related ( grade 2 lymphostasis and grade 2 lymphoedema , each in one patient in the trastuzumab group , and grade 2 thrombosis and grade 2 deep vein thrombosis , each in one patient in the chemotherapy-alone group ) .
CONCLUSIONS	These results show a sustained benefit in event-free survival from trastuzumab-containing neoadjuvant therapy followed by adjuvant trastuzumab in patients with locally advanced or inflammatory breast cancer , and provide new insight into the association between pathological complete remission and long-term outcomes in HER2-positive disease .

###25516197
OBJECTIVE	A better understanding of the stroke risk factors in children with congenital heart disease ( CHD ) could inform stroke prevention strategies .
OBJECTIVE	We analyzed pediatric stroke associated with CHD in a large community-based case-control study .
METHODS	From 2.5 million children ( aged < 20 years ) enrolled in a Northern California integrated healthcare plan , we identified children with ischemic and hemorrhagic strokes and randomly selected age - and facility-matched stroke-free controls ( 3 per case ) .
METHODS	We determined exposure to CHD ( diagnosed before stroke ) and used conditional logistic regression to analyze stroke risk factors .
RESULTS	CHD was identified in 15 of 412 cases ( 4 % ) versus 7 of 1236 controls ( 0.6 % ) .
RESULTS	Cases of childhood stroke ( occurring between ages 29 days to 20 years ) with CHD had 19-fold ( odds ratio , 19 ; 95 % confidence interval 4.2-83 ) increased stroke risk compared to controls .
RESULTS	History of CHD surgery was associated with > 30-fold ( odds ratio , 31 ; confidence interval 4-241 ) increased risk of stroke in children with CHD when compared with controls .
RESULTS	After excluding perioperative strokes , the history of CHD surgery still increased the childhood stroke risk ( odds ratio , 13 ; confidence interval 1.5-114 ) .
RESULTS	The majority of children with stroke and CHD were outpatients at the time of stroke , and almost half the cases who underwent cardiac surgery had their stroke > 5 years after the most recent procedure .
RESULTS	An estimated 7 % of ischemic and 2 % of hemorrhagic childhood strokes in the population were attributable to CHD .
CONCLUSIONS	CHD is an important childhood stroke risk factor .
CONCLUSIONS	Children who undergo CHD surgery remain at elevated risk outside the perioperative period and would benefit from optimized long-term stroke prevention strategies .

###25439604
OBJECTIVE	To analyze differences in the cost of treatment for infants randomized to primary intraocular lens ( IOL ) implantation versus optical correction with a contact lens ( CL ) after unilateral cataract surgery in the Infant Aphakia Treatment Study ( IATS ) .
METHODS	Retrospective cost analysis of a prospective , randomized clinical trial based on Georgia Medicaid reimbursement data as well as actual costs of supplies used during the study , adjusted for inflation .
METHODS	The IATS is a multicenter ( n = 12 ) , randomized clinical trial comparing the optical treatment of aphakia with either primary IOL implantation ( n = 57 ) or CL correction ( n = 57 ) in 114 infants with unilateral congenital cataract .
METHODS	One hundred fourteen infants underwent unilateral cataract surgery and were either corrected optically by primary IOL implantation at the time of surgery or were corrected with a CL after surgery .
METHODS	The mean cost of cataract surgery and all additional surgeries , examinations , and supplies used up to 5 years of age .
RESULTS	The 5-year treatment cost of an infant with a unilateral congenital cataract corrected optically with an IOL was $ 27 090 versus $ 25 331 for a patient treated with a CL after initial cataract surgery .
RESULTS	The total cost of supplies was $ 3204 in the IOL group versus $ 7728 in the CL group .
CONCLUSIONS	Unilateral cataract surgery in infancy coupled with primary IOL implantation is approximately 7 % more expensive than aphakia and CL correction .
CONCLUSIONS	Patient costs are more than double with CL versus IOL treatment .

###24361227
BACKGROUND	Paclitaxel and gemcitabine ( PG ) combination chemotherapy is effective as a maintenance chemotherapeutic regimen in metastatic breast cancer ( MBC ) patients because it increases progression-free survival ( PFS ) , which increases overall survival ( OS ) .
BACKGROUND	The primary purpose of our study was to investigate the association between genetic polymorphisms in the genes involved in PG pathways and clinical outcomes in MBC patients treated with PG chemotherapy .
METHODS	A total of 324 MBC patients were enrolled in this prospective multicenter trial of PG as the first-line chemotherapy .
METHODS	Eighty-five of the 324 patients from two institutes were available for analysis of single nucleotide polymorphisms ( SNPs ) .
METHODS	Germline DNA was extracted from peripheral blood mononuclear cells .
METHODS	Thirty-eight SNPs in 15 candidate genes selected from pathways that may influence the metabolism and transport of , or sensitivity , to PG were analysed .
RESULTS	The median PFS and OS of all 324 patients were 8.7 months ( 95 % confidence interval [ CI ] : 7.5-9 .6 months ) and 26.9 months ( 95 % CI : 23.6-30 .1 months ) , respectively .
RESULTS	An SNP in SLC28A3 ( rs7867504 , C/T ) was associated with OS ( CC or CT versus TT : 37 versus 21 months , p = 0.027 , hazard ratio [ HR ] 2.6 , 95 % CI : 1.1-6 .3 ) .
RESULTS	SLC29A1 GA haplotype had a significantly shorter OS ( p = 0.030 , HR 3.391 , 95 % CI : 1.13-10 .19 ) .
RESULTS	RRM1 ( ribonucleotide reductase large subunit M1 ) SNP ( rs9937 ) , and haplotypes ATAA and ATGA were significantly associated with neurotoxicity .
CONCLUSIONS	Genetic polymorphisms in SLC28A3 , SLC29A1 and RRM1 can influence the clinical outcome of MBC patients treated with PG chemotherapy .
CONCLUSIONS	Further studies on the functional mechanisms relating to these germline polymorphisms in these genes are warranted .

###24376274
BACKGROUND	JTT-751 is a novel phosphate binder containing ferric citrate as the active ingredient .
METHODS	In this Phase 3 , multicenter , randomized , open-label , parallel-group study , we compared the efficacy and safety of JTT-751 and sevelamer hydrochloride in patients undergoing hemodialysis .
METHODS	A total of 230 patients with a serum phosphate 1.97 and < 3.23 mmol/L were randomized to JTT-751 ( dose adjusted between 1.5 and 6.0 g/day ) or sevelamer hydrochloride ( dose adjusted between 3.0 and 9.0 g/day ) for 12 weeks .
METHODS	The primary outcome was change in serum phosphate from baseline to end of treatment .
METHODS	Secondary outcomes included the changes in corrected serum calcium and intact parathyroid hormone ( PTH ) .
METHODS	The changes in ferritin , transferrin saturation and erythropoiesis-stimulating agent dose were additional outcomes .
RESULTS	Changes in serum phosphate at the end of treatment were -0.82 mmol/L in the JTT-751 group and -0.78 mmol/L in the sevelamer group , establishing non-inferiority of JTT-751 compared with sevelamer ( least squares mean , -0.03 mmol/L ; 95 % confidence interval , -0.13 to 0.07 mmol/L ) .
RESULTS	Corrected serum calcium increased and PTH decreased from baseline within both groups ; changes between groups were similar .
RESULTS	Gastrointestinal disorders were the most common adverse events in both groups ; the incidence of diarrhea was higher in the JTT-751 group , while constipation occurred frequently in the sevelamer group .
RESULTS	Treatment with JTT-751 resulted in significant relative increases in serum ferritin and transferrin saturation .
CONCLUSIONS	Efficacy and safety of JTT-751 was comparable to sevelamer in patients on hemodialysis with hyperphosphatemia .
CONCLUSIONS	Differential adverse effects were observed ; biochemical markers of iron status increased in patients treated with JTT-751 .
BACKGROUND	CTI-111433 ( The Japan Pharmaceutical Information Center at : http / / www.clinicaltrials.jp ) .
BACKGROUND	Date of registration : 7 March 2011 .

###24678983
BACKGROUND	Little is known as to whether primary care teams ' perceptions of how well they have implemented the Chronic Care Model ( CCM ) corresponds with their patients ' own experience of chronic illness care .
BACKGROUND	We examined the extent to which practice members ' perceptions of how well they organized to deliver care consistent with the CCM were associated with their patients ' perceptions of the chronic illness care they have received .
METHODS	Analysis of baseline measures from a cluster randomized controlled trial testing a practice facilitation intervention to implement the CCM in small , community-based primary care practices .
METHODS	All practice `` members '' ( i.e. , physician providers , non-physician providers , and staff ) completed the Assessment of Chronic Illness Care ( ACIC ) survey and adult patients with 1 or more chronic illnesses completed the Patient Assessment of Chronic Illness Care ( PACIC ) questionnaire .
RESULTS	Two sets of hierarchical linear regression models accounting for nesting of practice members ( N = 283 ) and patients ( N = 1,769 ) within 39 practices assessed the association between practice member perspectives of CCM implementation ( ACIC scores ) and patients ' perspectives of CCM ( PACIC ) .
RESULTS	ACIC summary score was not significantly associated with PACIC summary score or most of PACIC subscale scores , but four of the ACIC subscales [ Self-management Support ( p < 0.05 ) ; Community Linkages ( p < 0.02 ) , Delivery System Design ( p < 0.02 ) , and Organizational Support ( p < 0.02 ) ] were consistently associated with PACIC summary score and the majority of PACIC subscale scores after controlling for patient characteristics .
RESULTS	The magnitude of the coefficients , however , indicates that the level of association is weak .
CONCLUSIONS	The ACIC and PACIC scales appear to provide complementary and relatively unique assessments of how well clinical services are aligned with the CCM .
CONCLUSIONS	Our findings underscore the importance of assessing both patient and practice member perspectives when evaluating quality of chronic illness care .
BACKGROUND	NCT00482768 .

###25946948
BACKGROUND	Copper IUD is a long term and reversible contraception which equals tubal ligation in terms of sterilization .
BACKGROUND	One of the barriers to using this contraception method is the fear and the pain associated with its insertion .
BACKGROUND	Eutectic mixture of local anesthetics ( EMLA ) 5 % is a local anesthetic that contains 25 mg lidocaine and 25 mg of prilocaine per gram .
BACKGROUND	Application of topical analgesic cream to the cervix for laser surgery , hysteroscopy and hysterosalpingography is known Aims : this study aimed to determine the effect of EMLA on IUD insertion pain .
METHODS	This triple blind clinical trial was conducted on 92 women in a clinic in Hamedan in 2012 .
METHODS	After applying the cream on the cervix , pain in three steps , after using Tenaculum , after inserting hystrometr and after inserting IUD and removing IUD insertion tube were assessed with visual analog scale and were compared in EMLA group and placebo group Statistical analysis used to determine and compare the pain of independent t tests , Mann-Whitney U test and repeated measures analysis of variance and chi-square tests to determine the homogeneity of variables and Fisher 's exact test was used .
RESULTS	Insertion hystrometr was determined as the most painful IUD insertion .
RESULTS	The mean pain at step 2 ( inserting hystrometr ) was ( 3.112.53 ) in EMLA group , ( 5.232.31 ) in placebo group .
RESULTS	EMLA cream significantly reduced the pain after using tenaculum ( P < 0.001 ) , pain inserting Hystrometr ( P < 0.001 ) and pain at IUD insertion and removing insertion tube ( P < 0.001 ) CONCLUSIONS : Topical Application of EMLA 5 % cream as a topical anesthetic on the cervix before insertion IUD reduced the pain during this procedure .

###25237463
OBJECTIVE	To evaluate how much the improvement of lower urinary tract symptoms ( LUTS ) affects sexual function and which storage symptoms or voiding symptoms have the greatest effect on sexual function .
METHODS	A total of 187 patients were enrolled in this study .
METHODS	Patients were randomly assigned to receive either tamsulosin 0.2 mg ( group A ) or tamsulosin 0.2 mg and solifenacin 5 mg ( group B ) .
METHODS	At 4 weeks and 12 weeks , the LUTS and sexual function of the patients were evaluated by use of the International Index of Erectile Function-5 ( IIEF5 ) , International Prostate Symptom Score ( IPSS ) , Overactive Bladder Symptom Score ( OABSS ) questionnaire , uroflowmetry , and bladder scan .
RESULTS	Both groups A and B showed statistically significant improvements in IPSS , OABSS , and quality of life ( QoL ) .
RESULTS	Group A showed improved maximum flow rate , mean flow rate , and residual urine volume by time .
RESULTS	Group B did not show an improvement in flow rate or residual urine volume but total voiding volume increased with time .
RESULTS	The IIEF5 score was not improved in either group .
RESULTS	In group A , the IIEF5 score dropped from 13.66 4.97 to 11.93 6.14 after 12 weeks ( p = 0.072 ) .
RESULTS	Group B showed a decline in the IIEF5 score from 13.19 5.91 to 12.45 6.38 ( p = 0.299 ) .
RESULTS	Although group B showed a relatively smaller decrease in the IIEF5 score , the difference between the two groups was not significant ( p = 0.696 ) .
CONCLUSIONS	Tamsulosin monotherapy and combination therapy with solifenacin did not improve erectile function despite improvements in voiding symptoms and QoL .
CONCLUSIONS	The improvement in storage symptoms did not affect erectile function .

###25450320
OBJECTIVE	We evaluate the effect of the protoconized anemia therapy on adverse events using the Hb and ferritin levels of individual patients undergoing maintenance hemodialysis ( MHD ) .
METHODS	Design : A randomized , parallel group , multi-center study .
METHODS	Two hundred sixty-six MHD patients .
METHODS	Intervention group : The doses of erythropoietin , iron , and vitamin C were adjusted every month based on the ferritin and hemoglobin ( Hb ) levels according to the protocol .
METHODS	Non-intervention group : The attending physician determined the doses of erythropoietin and iron .
RESULTS	The maintenance rate of target Hb and ferritin levels were significantly higher in the Intervention group than in the Non-intervention group .
RESULTS	The frequency of hospitalization was significantly lower for patients with a higher maintenance rate of target Hb levels than for those with a lower maintenance rate .
CONCLUSIONS	Using an anemia treatment protocol according to the individual Hb and ferritin levels of hemodialysis patients might stabilize the Hb and ferritin levels , which in turn could contribute to the lower frequency of adverse events in MHD patients .

###24645985
BACKGROUND	The impact of long-acting calcium channel blocker ( CCB ) administration on serial changes in left ventricular ( LV ) function and morphology in hypertensive patients with LV hypertrophy remains unclear .
BACKGROUND	This study attempted to clarify this impact by comparing the effects of administration of azelnidipine with that of amlodipine using conventional and speckle tracking echocardiography .
METHODS	An equal number ( 16 ) of 32 hypertensive patients was prospectively assigned to a group administered 5 mg of amlodipine/day or a group administered 16 mg of azelnidipine/day .
METHODS	LV function and morphology was examined by conventional and speckle tracking echocardiography at baseline and at 1 , 3 , 6 , and 12 months after treatment initiation .
RESULTS	Both groups were found to have experienced a significant decrease in systolic blood pressure by 1 month after treatment initiation ; a significant reduction in septal thickness and LV mass index at 6 and 12 months .
RESULTS	Transmitral flow E/A ratio and early diastolic mitral annular velocity at lateral wall significantly improved at 12 months .
RESULTS	On the other hand , a significant improvement of global longitudinal strain was observed earlier than the above indexes at 3 , 6 , and 12 months .
RESULTS	Ar-A duration difference was significantly decreased at 3 months .
RESULTS	The global circumferential strain improved significantly at 3 months , but there were no significant changes in mid - / apical circumferential and radial strains throughout the study period .
CONCLUSIONS	Azelnidipine has beneficial effects on LV mass regression , transmitral flow , tissue Doppler , and LV longitudinal strain that are comparable to those of amlodipine on the same parameters .

###24961093
OBJECTIVE	To observe the clinical efficacy of sodium cromoglicate eye drops combined with Yupingfeng granules in the treatment of allergic conjunctivitis .
METHODS	A total of 118 patients with allergic conjunctivitis were randomly divided into a combined sodium cromoglicate and Yupingfeng Granule ( treatment ) group ( n = 74 ) and a sodium cromoglicate ( control ) group ( n = 44 ) .
METHODS	Clinical efficacy of the two treatments was evaluated by observing the changes in patients ' symptoms and physical signs before and after their respective treatments .
RESULTS	Following treatment , the symptoms and physical signs related to allergic conjunctivitis were significantly alleviated in all 118 cases .
RESULTS	The total efficacy of the combined sodium cromoglicate and Yupingfeng granule treatment was 91.9 % , which was significantly higher than the value of 75.0 % obtained with sodium cromoglicate alone ( P < 0.05 ) .
CONCLUSIONS	Combined therapy of sodium cromoglicate eye drops and Yupingfeng granules had a high efficacy and no significant adverse reactions .
CONCLUSIONS	Therefore , this treatment deserves to be considered for wide application in clinical settings .

###26117164
OBJECTIVE	To examine if implicit emotion regulation ( occurring outside of awareness ) is related to binge eating disorder ( BED ) symptomatology and explicit emotion regulation ( occurring within awareness ) , and can be altered via intervention .
METHODS	Implicit emotion regulation was assessed via the Emotion Conflict Task ( ECT ) among a group of adults with BED .
METHODS	Study 1 correlated BED symptomatology and explicit emotion regulation with ECT performance at baseline ( BL ) and after receiving BED treatment ( PT ) .
METHODS	Study 2 generated effect sizes comparing ECT performance at BL and PT with healthy ( non-eating disordered ) controls ( HC ) .
RESULTS	Study 1 yielded significant correlations ( p < .05 ) between both BED symptomatology and explicit emotion regulation with ECT performance .
RESULTS	Study 2 found that compared to BL ECT performance , PT shifted ( d = -.27 ) , closer to HC .
RESULTS	Preliminary results suggest a ) BED symptomatology and explicit emotion regulation are associated with ECT performance , and b ) PT ECT performance normalized after BED treatment .
CONCLUSIONS	Implicit emotion regulation may be a BED treatment mechanism because psychotherapy , directly or indirectly , decreased sensitivity to implicit emotional conflict .
CONCLUSIONS	Further understanding implicit emotion regulation may refine conceptualizations and effective BED treatments .

###25066648
OBJECTIVE	The purpose of our study was to investigate the effects of Kinesio Taping ( ) Application with Complex Decongestive Therapy ( CDT ) in patients with lymphedema .
METHODS	45 patients were randomly divided into 3 groups ( CDT including Bandage , CDT including Bandage + Kinesio Tape ( ) , CDT including Kinesio Tape ( ) without bandage ) .
METHODS	Assessments included the severity of the symptoms such as pain , discomfort , heaviness , tension , stiffness and weakness .
METHODS	Bilateral circumference measurements were done for evaluation of the edema .
RESULTS	Symptoms were decreased in all three groups ( p < 0.05 ) .
RESULTS	CDT was found effective only during treatment in arm volume ( p < 0.05 ) .
RESULTS	Kinesio Taping ( ) applied with CDT had effect of decreasing edema after 10 days of treatment period ( p < 0.05 ) and for control period ( p < 0.05 ) .
RESULTS	Only the application of Kinesio Taping ( ) group also had significant decrease at edema ( p < 0.05 ) .
CONCLUSIONS	Kinesio Taping ( ) Application along with CDT may have a better effect on decreasing lymphedema which can stimulate the reduction of edema for long term effects .

###25229956
OBJECTIVE	To study the efficacy of short-term educational intervention for parents of preschool children with anxiety .
METHODS	Forty-nine children with Spence Preschool Anxiety Scale ( SPAS ) scores of 48 were randomly divided into intervention and control groups .
METHODS	The children 's parents in the intervention group received a collective curriculum on children 's anxiety management six times , while the control group was only followed up .
METHODS	All children were evaluated for anxiety by the SPAS 3 and 6 months later , and then the results were compared between the two groups .
RESULTS	The test was completed in 21 cases of the intervention group and 22 cases of the control group .
RESULTS	At month 3 , the intervention group had a significantly lower percentage of children with SPAS scores of 48 than the control group ( 62 % vs 91 % ; P < 0.05 ) , and this percentage was also significantly lower in the intervention group than in the control group at month 6 ( 52 % vs 82 % ; P < 0.05 ) .
RESULTS	At month 3 , the intervention group had a significantly reduced mean SPAS score , which was significantly lower than that of the control group ( 69 12 vs 81 12 ; P < 0.01 ) .
RESULTS	At month 6 , both groups showed significant decreases in SPAS score , but still the SPAS score was significantly lower in the intervention group than in the control group ( 65 13 vs 78 13 ; P < 0.01 ) .
CONCLUSIONS	Early short-term education for parents can relieve their preschool children 's anxiety effectively , but the long-term effect needs to be evaluated by follow-up .

###25813656
OBJECTIVE	To report penile integrity measures , including stretched penile length ( SPL ) , from a randomized , double-blind , double-dummy , placebo-controlled trial evaluating treatment with tadalafil initiated after nerve-sparing radical prostatectomy ( nsRP ) .
METHODS	Patients aged 68 years were randomized after nsRP 1:1:1 to 9-month double-blind treatment ( DBT ) with tadalafil 5 mg once daily ( OaD ) , 20-mg tadalafil on-demand ( `` pro-re-nata '' ; PRN ) , or placebo , followed by 6-week drug-free washout and 3-month open-label OaD treatment .
METHODS	Secondary outcome measures included the change in SPL from pre-nsRP to the end of DBT ( analysis of covariance adjusting for treatment , country , baseline , age , and nerve-sparing score ) , responses to Sexual Encounter Profile ( SEP ) questions 1-3 ( mixed models for repeated measures adjusting for treatment , country , visit , visit-treatment-interaction , age ) , and Standardized Morning Erection Question ( Cochran-Mantel-Haenszel test adjusted for age and country ) .
RESULTS	Four hundred twenty-three patients were randomized to tadalafil OaD ( N = 139 ) , tadalafil PRN ( N = 143 ) , and placebo ( N = 141 ) .
RESULTS	Greater retainment of SPL was observed with tadalafil OaD vs placebo at the end of DBT ( least-square mean [ 95 % confidence interval ] difference OaD vs placebo , 4.1 mm [ 0.4 to 7.8 mm ] ; P = .032 ) .
RESULTS	No significant effects on SPL were found for tadalafil PRN vs placebo , or for the nerve-sparing score .
RESULTS	Penile tumescence ( SEP1 ) and ability for vaginal insertion ( SEP2 ) significantly improved vs placebo at the end of double-blind and open-label treatment for patients randomized to tadalafil OaD only .
RESULTS	The ability for successful sexual intercourse ( SEP3 ) significantly improved with tadalafil OaD vs placebo only during DBT .
RESULTS	The distribution of Standardized Morning Erection Question responses was different at the end of DBT ( P = .045 ) ; 34.2 % of patients on tadalafil OaD , 50.0 % on tadalafil PRN , and 56.5 % on placebo reported absence of morning erections .
CONCLUSIONS	These data suggest the early initiation of tadalafil OaD protects from penile length loss and may contribute to protection from structural cavernosal changes after nsRP .

###24356624
BACKGROUND	Efficacy and safety of first-line axitinib/paclitaxel/carboplatin versus bevacizumab/paclitaxel/carboplatin in advanced non-squamous non-small-cell lung cancer ( NSCLC ) was evaluated .
METHODS	Patients with stage IIIB/IV disease stratified by adjuvant therapy and gender were randomised 1 : 1 to axitinib ( 5 mg twice daily ) or bevacizumab [ 15 mg/kg every 3 weeks ( Q3W ) ] , both with paclitaxel ( 200 mg/m ( 2 ) Q3W ) / carboplatin ( AUC 6 mg min/ml Q3W ) .
RESULTS	The trial was discontinued after preliminary analysis .
RESULTS	Median progression-free survival ( primary end point ) for axitinib ( N = 58 ) and bevacizumab ( N = 60 ) , respectively , was 5.7 and 6.1 months [ hazard ratio ( HR ) 1.09 , 95 % confidence interval ( CI ) 0.68-1 .76 ; one-sided stratified P = 0.64 ] ; median overall survival was 10.6 and 13.3 months ( HR 1.12 , 95 % CI 0.74-1 .69 ; one-sided stratified P = 0.70 ) .
RESULTS	Objective response rates ( 95 % CI ) were 29.3 % ( 18.1-42 .7 ) and 43.3 % ( 30.6-56 .8 ) , respectively ; risk ratio 0.676 ( 95 % CI 0.41-1 .11 ; one-sided stratified P = 0.94 ) .
RESULTS	The most common grade 3/4 adverse events included neutropenia ( 28 % versus 20 % ) , fatigue ( 14 % versus 7 % ) , and hypertension ( 14 % versus 5 % ) .
RESULTS	Patient-reported outcomes based on the EORTC QLQ-C30 were similar between arms .
CONCLUSIONS	In patients with advanced non-squamous NSCLC , axitinib/paclitaxel/carboplatin did not improve efficacy versus bevacizumab/paclitaxel/carboplatin , and was less well tolerated .

###24764677
OBJECTIVE	To evaluate the effect of resistance training ( RT ) on non alcoholic liver disease ( NAFLD ) patients .
METHODS	A randomized clinical trial enrolling NAFLD patients without secondary liver disease ( e.g. , without hepatitis B virus , hepatitis C virus or excessive alcohol consumption ) .
METHODS	Patients were randomly allocated either to RT , three times weekly , for 3 mo or a control arm consisting of home stretching .
METHODS	The RT included leg press , chest press , seated rowing , latissimus pull down etc. with 8-12 repetitions , 3 sets for each exercise , for a total duration of 40 min .
METHODS	Hepatic ultrasound , fasting blood tests , anthropometrics and body composition by dual energy X-ray absorptiometry were assessed .
METHODS	At baseline and follow-up , patients filled out a detailed semi-quantitative food frequency questionnaire reporting their habitual nutritional intake .
METHODS	Steatosis was quantified by the hepatorenal-ultrasound index ( HRI ) representing the ratio between the brightness level of the liver and the right kidney .
METHODS	The HRI has been previously demonstrated to be highly reproducible and was validated against liver biopsy and proton magnetic resonance spectroscopy .
RESULTS	Eighty two patients with primary NAFLD were randomized to receive 3 mo of either RT or stretching .
RESULTS	After dropout or exclusion from analysis because of protocol violation ( weight change > 3 kg ) , thirty three patients in the RT arm and 31 in the stretching arm completed the study per protocol .
RESULTS	All baseline characteristics were similar for the two treatment groups with respect to demographics , anthropometrics and body composition , blood tests and liver steatosis on imaging .
RESULTS	HRI score was reduced significantly in the RT arm as compared to the stretching arm ( -0.25 0.37 vs -0.05 0.28 , P = 0.017 ) .
RESULTS	The RT arm had a significantly higher reduction in total , trunk and android fat with increase in lean body mass .
RESULTS	There was no correlation between the reduction in HRI in the RT arm and weight change during the study , but it was positively correlated with the change in trunk fat ( r = 0.37 , P = 0.048 ) .
RESULTS	The RT arm had a significant reduction in serum ferritin and total cholesterol .
RESULTS	There was no significant difference between arms in dietary changes and these did not correlate with HRI change .
CONCLUSIONS	Three months RT improves hepatic fat content accompanied by favorable changes in body composition and ferritin .
CONCLUSIONS	RT may serve as a complement to treatment of NAFLD .

###26093877
BACKGROUND	There are limited data on prognosis and outcomes of patients with new-onset atrial fibrillation ( AF ) compared with those with a prior history of AF .
RESULTS	We conducted a comparison of these 2 groups in the AFFIRM trial .
RESULTS	New-onset AF was the qualifying arrhythmia in 1,391 patients ( 34 % ) .
RESULTS	Compared with patients with prior history of AF , patients with new-onset AF were more likely to have a history of heart failure .
RESULTS	There was no mortality difference between rate control ( RaC ) and rhythm control ( RhC ) among patients with new-onset AF ( 17 % vs 20 % , P = .152 ) .
RESULTS	In the univariate model , new-onset AF was associated with increased risk of mortality compared with history of prior AF ( RaC unadjusted hazard ratio [ HR ] 1.36 [ P = .010 ] , RhC unadjusted HR 1.39 [ P = .003 ] ) .
RESULTS	However , after multivariate adjustments , new-onset AF did not carry an increased risk of mortality ( RaC adjusted HR 1.14 [ P = .370 ] , RhC adjusted HR 1.16 [ P = .248 ] ) .
RESULTS	Subjects with new-onset AF randomized to the RhC arm were more likely to remain in normal sinus rhythm at follow-up ( adjusted HR 0.79 , P = .012 ) compared with patients with prior history of AF .
CONCLUSIONS	In a multivariable analysis adjusting for confounders , new-onset AF was not associated with increased mortality compared with prior history of AF regardless of the treatment strategy .
CONCLUSIONS	Patients with new-onset AF treated with the rhythm control strategy were more likely to remain in normal sinus rhythm on follow-up .

###24621065
OBJECTIVE	Previous studies have shown a positive effect of zinc as an adjunctive therapy on reducing depressive symptoms .
OBJECTIVE	However , to our knowledge , no study has examined the effect of zinc monotherapy on mood .
OBJECTIVE	The aim of the present study was to determine the effects of zinc monotherapy on depressive symptoms and serum brain-derived neurotrophic factor ( BDNF ) levels in overweight or obese subjects .
METHODS	Fifty overweight or obese subjects were randomly assigned into two groups and received either 30 mg zinc or placebo daily for 12 weeks .
METHODS	At baseline and post-intervention , depression severity was assessed using Beck depression inventory II ( BDI II ) , and serum BDNF and zinc levels were determined by enzyme-linked immunosorbent assay and atomic absorption spectrophotometry , respectively .
RESULTS	The trial was completed with 46 subjects .
RESULTS	After a 12-week supplementation , serum zinc and BDNF levels increased significantly in the zinc-supplemented group compared with the placebo group .
RESULTS	BDI scores declined in both the groups at the end of the study , but reduction in the zinc-supplemented group was significantly higher than the placebo group .
RESULTS	More analysis revealed that following supplementation , BDI scores decreased in subgroup of subjects with depressive symptoms ( BDI 10 ) ( n = 30 ) , but did not change in the subgroup of non-depressed subjects ( BDI < 10 ) ( n = 16 ) .
RESULTS	Moreover , a significant inverse correlation was observed between serum BDNF levels and depression severity in all participants .
RESULTS	Interestingly , a significant positive correlation was found between serum BDNF and zinc levels at baseline .
CONCLUSIONS	Zinc monotherapy improves mood in overweight or obese subjects most likely through increasing BDNF levels .

###24419482
OBJECTIVE	Gastroparesis is a well-known complication to diabetes mellitus ( DM ) .
OBJECTIVE	Dietary advice is considered to be of importance to reduce gastrointestinal ( GI ) symptoms in patients with diabetic gastroparesis , but no randomized controlled trials exist .
OBJECTIVE	Our aim was to compare GI symptoms in insulin treated DM subjects with gastroparesis eating a diet with small particle size ( `` intervention diet '' ) with the recommended diet for DM ( `` control diet '' ) .
METHODS	56 subjects with insulin treated DM and gastroparesis were randomized to the intervention diet or the control diet .
METHODS	The patients received dietary advice by a dietitian at 7 occasions during 20 weeks .
METHODS	GI symptom severity , nutrient intake and glycemic control were measured before and after the intervention .
RESULTS	A significantly greater reduction of the severity of the key gastroparetic symptoms-nausea/vomiting ( P = 0.01 ) , postprandial fullness ( P = 0.02 ) and bloating ( P = 0.006 ) - were seen in patients who received the intervention diet compared with the control diet , and this was also true for regurgitation/heartburn ( P = 0.02 ) , but not for abdominal pain .
RESULTS	Anxiety was reduced after the intervention diet , but not after the control diet , whereas no effect on depression or quality of life was noted in any of the groups .
RESULTS	A higher fat intake in the intervention group was noted , but otherwise no differences in body weight , HbA1c or nutrient intake were seen .
CONCLUSIONS	A small particle diet improves the key symptoms of gastroparesis in patients with diabetes mellitus .
CONCLUSIONS	( ClinicalTrials.gov NCT01557296 ) .

###24650125
BACKGROUND	To evaluate if an opiate sparing multimodal regimen of dexamethasone , gabapentin , ibuprofen and paracetamol had better analgesic effect , less side effects and was safe compared to a traditional morphine and paracetamol regimen after cardiac surgery .
METHODS	Open-label , prospective randomized controlled trial .
METHODS	180 patients undergoing cardiac procedures through median sternotomy , were included in the period march 2007-August 2009.151 patients were available for analysis .
METHODS	Pain was assessed with the 11-numeric rating scale ( 11-NRS ) .
RESULTS	Patients in the multimodal group demonstrated significantly lower average pain scores from the day of surgery throughout the third postoperative day .
RESULTS	Extensive nausea and vomiting , was found in no patient in the multimodal group but in 13 patients in the morphine group , p < 0.001 .
RESULTS	Postoperative rise in individual creatinine levels demonstrated a non-significant rise in the multimodal group , 33.053.4 vs. 19.948.5 , p = 0.133 .
RESULTS	Patients in the multimodal group suffered less major in-hospital events in crude numbers : myocardial infarction ( MI ) ( 1 vs. 2 , p = 0.54 ) , stroke ( 0 vs. 3 , p = 0.075 ) , dialysis ( 1 vs. 2 , p = 0.54 ) , and gastrointestinal ( GI ) bleeding ( 0 vs. 1 , p = 0.31 ) .
RESULTS	30-day mortality was 1 vs. 2 , p = 0.54 .
CONCLUSIONS	In patients undergoing cardiac surgery , a multimodal regimen offered significantly better analgesia than a traditional opiate regimen .
CONCLUSIONS	Nausea and vomiting complaints were significantly reduced .
CONCLUSIONS	No safety issues were observed with the multimodal regimen .
BACKGROUND	Clinicaltrials.gov identifier : NCT01966172 .

###24557728
OBJECTIVE	Antiretroviral drug regimen choice may influence changes in body composition .
OBJECTIVE	The objective of this study was to compare changes in body composition between ritonavir-boosted atazanavir ( ATV/r ) and ritonavir-boosted lopinavir ( LPV/r ) over 96 weeks using data from a substudy of CASTLE , which compared once-daily ATV/r with twice-daily LPV/r , both in combination with tenofovir disoproxil fumarate/emtricitabine in treatment-nave patients with HIV-1 infection .
METHODS	We examined 224 patients ( 125 on ATV/r ; 99 on LPV/r ) at baseline , 48 and 96 weeks using dual-energy X-ray absorptiometry and computerised tomography .
RESULTS	In the lowest baseline body mass index ( BMI ) group , there were significantly greater gains at week 96 for ATV/r than for LPV/r in subcutaneous adipose tissue and in visceral adipose tissue ( VAT ) .
RESULTS	By week 96 , patients with lowest baseline CD4 cell counts on ATV/r had 28 % increases in VAT versus 14 % reductions for patients receiving LPV/r .
RESULTS	Those with the lowest baseline BMI on ATV/r had 19 % increases in VAT versus reductions of 5 % for patients on LPV/r .
RESULTS	In the highest baseline BMI group , the mean increase in triglycerides was 6 and 70 % in the ATV/r and LPV/r arms , respectively .
RESULTS	Compared with baseline , an increase in proportion of patients with high waist circumference ( WC ) / high triglycerides at 96 weeks was noted in both treatment arms , but this increase was numerically greater with LVP/r ( 18 % ) than with ATV/r ( 11 % ) .
CONCLUSIONS	Truncal fat gains on ATV/r primarily led to increases in WC , which may reflect return to health , while on LPV/r increases in WC and triglycerides occurred .
CONCLUSIONS	Changes in body composition with antiretroviral therapy are influenced by treatment choice and baseline characteristics .

###24968990
OBJECTIVE	To establish the cost-effectiveness of long-term humidification therapy ( LTHT ) added to usual care for patients with moderate or severe chronic obstructive pulmonary disease or bronchiectasis .
METHODS	Resource usage in a 12-month clinical trial of LTHT was estimated from hospital records , patient diaries , and the equipment supplier .
METHODS	Health state utility values were derived from the St. Georges Respiratory Questionnaire ( SGRQ ) total score .
METHODS	All patients who remained in the trial for 12 months and who had at least 90 days of diary records were included ( 87 of 108 ) .
RESULTS	Clinical costs were NZ $ 3973 ( 95 % confidence interval [ CI ] $ 1614 - $ 6332 ) for the control group and NZ $ 3331 ( 95 % CI $ 948 - $ 6920 ) for the intervention group .
RESULTS	The mean health benefit per patient was -6.9 SGRQ units ( 95 % CI -13.0 to -7.2 ; P < 0.05 ) or +0.0678 quality-adjusted life-years ( 95 % CI 0.001-0 .135 ) .
RESULTS	With the intervention costing NZ $ 2059 annually , the mean cost per quality-adjusted life-year was NZ $ 20,902 ( US $ 18,907 ) and the bootstrap median was NZ $ 19,749 ( 2.5 th percentile - $ 40,923 , 97.5 th percentile $ 221,275 ) .
RESULTS	At a willingness-to-pay ( WTP ) threshold of NZ $ 30,000 , the probability of cost-effectiveness was 61 % , ranging from 49 % to 72 % as the cost of LTHT was varied by 30 % .
RESULTS	At a WTP of NZ $ 20,000 , the probability was 49 % ( range 34 % -61 % ) .
CONCLUSIONS	LTHT is moderately cost-effective for patients with moderate to severe chronic obstructive pulmonary disease or bronchiectasis at a WTP threshold that is acceptable for public funding of medicines in New Zealand .
CONCLUSIONS	These findings must be interpreted with caution because of the modest size of the clinical study , necessary lack of blinding in the clinical trial , and uncertainty in estimating health state utility from the SQRQ .

###24836354
OBJECTIVE	To evaluate whether clinically relevant concentrations of stimulated C-peptide in response to a mixed-meal tolerance test can be detected after almost 30 years of diabetes in people included in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications cohort .
METHODS	Mixed-meal tolerance tests were performed in a sample of 58 people .
METHODS	C-peptide levels were measured using a chemiluminescent immunoassay .
METHODS	This sample size assured a high probability of detecting C-peptide response if the true prevalence was at least 5 % , a level that would justify the subsequent assessment of C-peptide in the entire cohort .
RESULTS	Of the 58 participants , 17 % showed a definite response , defined as one or more post-stimulus concentrations of C-peptide > 0.03 nmol/l , and measurable concentrations were found in all participants .
CONCLUSIONS	These results show that a stimulated C-peptide response can be measured in some people with long-term Type 1 diabetes .
CONCLUSIONS	Further investigation of all participants in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications study will help relate long-term residual C-peptide response to glycaemia over time and provide insight into the relevance of this response in terms of insulin dose , severe hypoglycaemia , retinopathy , nephropathy and macrovascular disease .
CONCLUSIONS	Establishing the clinical relevance of long-term C-peptide responses is important in understanding the impact that therapy to preserve or improve - cell function may have in patients with long-term Type 1 diabetes .

###25146896
OBJECTIVE	To clarify the effectiveness of Chinese herbal fomentation in treating chronic neck pain by means of changes in cervical kinematics .
METHODS	Seventy-six patients with chronic neck pain were included in the study and were randomized into two groups based on the random number generator of the SPSS software : fomentation combined with Chinese herbal ( Group 1 ) and fomentation without any medicine ( Group 2 ) .
METHODS	In both groups , the fomentation lasted for 60 min and heated to 35 C , once a day for 28 consecutive days .
METHODS	Standard lateral radiographs of the cervical spine were obtained including the neutral , full flexion , and full extension positions .
METHODS	Before and after intervention , the following parameters were used to evaluate the changes in kinematics : range of motion ( ROM ) , sagittal alignment and instantaneous center of rotation ( ICR ) .
RESULTS	After treatment , the ROM was signifcantly higher than that of before treatment in Group 1 ( 51.5 , 95 % CI : 49.8-55 .9 ; P < 0.05 ) .
RESULTS	There was no significant difference between before and after treatment in Group 2 ( P > 0.05 ) .
RESULTS	Although C2-C7 cervical alignment was increased in both groups after treatment , no significant difference was detected between before and after treatment ( P > 0.05 ) .
RESULTS	For Group 1 , the significant X coordinate variation was only observed at C5/C6 level ( 38.1 ; 95 % CI : 34.0 , 42.1 ; P < 0.05 ) .
RESULTS	There was a significant upward trend in the Y coordinate of the ICR at C5/C6 ( -30.5 ; 95 % CI : -34.3 , -26.8 ; P < 0.05 ) and C6/C7 after treatment ( -6.1 ; 95 % CI : -6.7 , -5.4 ; P < 0.05 ) .
RESULTS	For Group 2 , the ICR location of each level was not statistically different between the pre - and post-treatment ( P > 0.05 ) .
CONCLUSIONS	Chinese herbal fomentation could improve abnormal mobility in terms of ROM and ICR .
CONCLUSIONS	Chinese herbal fomentation might be an effective treatment for chronic neck pain .

###24462960
BACKGROUND	Theoretically , salt supplementation should promote diuresis through increasing the glomerular filtration rate ( GFR ) during treatment of acute decompensated heart failure ( ADHF ) even with low-dose furosemide ; however , there is little evidence to support this idea .
RESULTS	This was a prospective , randomized , open-label , controlled trial that compared the diuretic effectiveness of salt infusion with that of glucose infusion supplemented with low-dose furosemide in 44 consecutive patients with ADHF .
RESULTS	Patients were randomly administered 1.7 % hypertonic saline solution supplemented with 40 mg furosemide ( salt infusion group ) or glucose supplemented with 40 mg furosemide ( glucose infusion group ) .
RESULTS	Our major end points were 24-hour urinary volume and GFR .
RESULTS	Urinary volume was greater in the salt infusion group than in the glucose infusion group ( 2,701 920 vs 1,777 797 mL ; P < .001 ) .
RESULTS	There was no significant difference in the estimated GFR at baseline .
RESULTS	Creatinine clearance for 24 h was greater in the salt infusion group than in the glucose infusion group ( 63.5 52.6 vs 39.0 26.3 mL min ( -1 ) 1.73 m ( -2 ) ; P = .048 ) .
CONCLUSIONS	Salt supplementation rather than salt restriction evoked favorable diuresis through increasing GFR .
CONCLUSIONS	The findings support an efficacious novel approach of the treatment of ADHF .

###25099397
OBJECTIVE	To examine the efficacy and safety of adjunctive armodafinil for major depressive episodes associated with bipolar I disorder .
METHODS	Adults meeting DSM-IV-TR criteria for bipolar I disorder and currently experiencing a major depressive episode while taking at least 4 weeks of conventional maintenance medication were enrolled in a placebo-controlled evaluation of adjunctive armodafinil 150 or 200 mg ( conducted January 2010-March 2012 ) .
METHODS	The primary efficacy measure was change from baseline to week 8 on the 30-item Inventory of Depressive Symptomatology-Clinician-Rated ( IDS-C30 ) total score in the 150-mg armodafinil group versus placebo .
RESULTS	Of 786 patients screened , 433 were randomized ( placebo , n = 199 ; armodafinil 150 mg , n = 201 ; armodafinil 200 mg , n = 33 ) .
RESULTS	The 200-mg armodafinil group was discontinued by protocol amendment due to lower than expected patient enrollment .
RESULTS	For the 150-mg armodafinil group versus placebo , there was a significantly greater decrease in least squares mean ( standard error of mean [ SEM ] ) IDS-C30 total score at week 8 ( -21.7 [ 1.1 ] vs -17.9 [ 1.1 ] ; P = .0097 ; Cohen d therapeutic effect size = 0.28 ) .
RESULTS	The proportion of IDS-C30 responders ( 50 % decrease from baseline ) was significantly higher for the 150-mg armodafinil group versus placebo at final visit ( 46 % [ 91/197 ] vs 34 % [ 67/196 ] ; P = .0147 ) .
RESULTS	The proportion of IDS-C30 remitters ( total score 11 ) was 21 % ( 42/197 ) for armodafinil 150 mg versus 17 % ( 34/196 ) for placebo ( P = .3343 ) at final visit .
RESULTS	Adverse events ( AEs ) observed in > 5 % of either the armodafinil 150 mg or placebo groups and more frequently with 150 mg armodafinil were diarrhea ( 9 % [ 17/198 ] vs 7 % [ 13/199 ] ) , and nausea ( 6 % [ 11/198 ] vs 5 % [ 9/199 ] ) , respectively .
RESULTS	In the 200-mg armodafinil group , there were 2 serious AEs ( n = 1 , hepatic failure leading to death ; n = 1 , acute hepatitis ) .
RESULTS	The death was not considered related to study treatment .
CONCLUSIONS	Adjunctive armodafinil 150 mg significantly improved symptoms of major depressive episodes associated with bipolar I disorder versus placebo and was generally well tolerated .
BACKGROUND	ClinicalTrials.gov identifier : NCT01072929 .

###25387805
OBJECTIVE	Despite the reported detrimental effects of international air travel on physical performance , a paucity of interventions have been scientifically tested and confirmed to benefit travelling athletes .
OBJECTIVE	Consequently , the aim of the present study was to examine the effects of sleep hygiene and artificial bright light interventions on physical performance following simulated international travel .
METHODS	In a randomized crossover design , 13 physically active males completed 24 h of simulated international travel with ( INT ) and without ( CON ) the interventions .
METHODS	The mild hypoxia and cramped conditions typically encountered during commercial air travel were simulated in a normobaric , hypoxic room .
METHODS	Physical performance , subjective jet-lag symptoms and mood states were assessed in the morning and evening on the day prior to and for two days post-travel .
METHODS	Sleep quantity and quality were monitored throughout each trial .
RESULTS	Sleep duration was significantly reduced during travel in both trials ( P < 0.01 ) , though total sleep duration during and following travel was almost significantly greater ( P = 0.06 ) in INT ( 17.0 ( 16.2-17 .8 ) h ) compared to CON ( 15.7 ( 14.9-16 .5 ) h ) .
RESULTS	Maximal-sprint and countermovement jump ( P < 0.05 ) , but not Yo-Yo Intermittent Recovery level 1 test ( P > 0.05 ) performance , were significantly reduced the evening of day 1 and 2 post-travel , with no differences between trials ( P > 0.05 ) .
RESULTS	Furthermore , vigour was significantly greater ( P = 0.04 ) the morning of day 2 in INT [ 5.3 ( 3.9-6 .7 ) ] compared to CON [ 2.8 ( 1.4-4 .2 ) ] , and subjective jet-lag symptoms and mood states were significantly worse on day 2 in CON only ( P < 0.05 ) .
CONCLUSIONS	Whilst reducing travel-induced sleep disruption may attenuate travel fatigue , no improvements in the recovery of physical performance were apparent .

###24727258
OBJECTIVE	The purpose of this study was to determine if 6-min walk test data assists in treatment decisions for patients withheart failure .
BACKGROUND	In the SCD-HeFT ( Sudden Cardiac Death in Heart Failure Trial ) , a pre-specified subgroup analysis showed that patients with New York Heart Association functional class III symptoms did not benefit from implantable cardioverter-defibrillator ( ICD ) therapy and appeared to be harmed by amiodarone , whereas New York Heart Association functional class II patients obtained significant survival benefit from ICD .
BACKGROUND	We postulated that a more objective measure of functional capacity , such as 6-min walk ( 6MW ) distance , might provide a better tool for selecting these preventive therapies .
METHODS	A 6MW test was performed before randomization in 2,397 patients .
METHODS	Median follow-up was 45.5 months .
METHODS	All-causemortality was the primary endpoint , with cause-specific mortality ( heart failure , arrhythmic ) examined insecondary analyses .
RESULTS	The hazard ratios ( HRs ) for ICD therapy compared to placebo were estimated within tertiles of baseline 6MW distance : HR : 0.42 ( 95 % confidence interval [ CI ] : 0.26 to 0.66 ) for 6MW distance > 386 m ( top tertile ) ; HR : 0.57 ( 95 % CI : 0.39 to 0.83 ) for 6MW distance 288 to 386 m ( middle tertile ) ; and HR : 1.02 ( 95 % CI : 0.75 to 1.39 ) for 6MW distance < 288 m ( bottom tertile ) .
RESULTS	The corresponding HRs for amiodarone compared to placebo were 0.68 ( 95 % CI : 0.46 to 1.02 ) for the top , 0.86 ( 95 % CI : 0.61 to 1.21 ) for the middle , and 1.56 ( 95 % CI : 1.17 to 2.09 ) for the bottom tertile .
RESULTS	The 6MW distance was inversely related to heart failure-related mortality but not to arrhythmic mortality .
RESULTS	ICD therapy reduced arrhythmic mortality in the top 2 tertiles of 6MW , but had no effect on heart failure mortality .
CONCLUSIONS	A baseline 6MW distance < 288 m identified a subgroup of SCD-HeFT patients who were harmed by amiodarone therapy and did not benefit from ICD .
CONCLUSIONS	( Sudden Cardiac Death in Heart Failure Trial [ SCD-HeFT ] ; NCT00000609 ) .

###24438438
BACKGROUND	Pre-diabetes and non-alcoholic fatty liver disease ( NAFLD ) are associated with an unhealthy lifestyle and pose extremely high costs to the healthcare system .
BACKGROUND	In this study , we aim to explore whether individualized aerobic exercise ( AEx ) and low carbohydrate diet ( LCh ) intervention affect hepatic fat content ( HFC ) in pre-diabetes via modification of gut microbiota composition and other post-interventional effects .
METHODS	A 6-month randomized intervention with 6-month follow-up is conducted from January 2013 to December 2015 .
METHODS	The target sample size for intervention is 200 postmenopausal women and middle-aged men aged 50-65year-old with pre-diabetes and NAFLD .
METHODS	The qualified subjects are randomized into 4 groups with 50 subjects in each group : 1 = AEx , 2 = LCh , 3 = AEx + LCh , and 4 = control .
METHODS	In addition , two age-matched reference groups ( 5 = pre-diabetes without NAFLD ( n = 50 ) and 6 = Healthy without pre-diabetes or NAFLD ( n = 50 ) ) are included .
METHODS	The exercise program consists of progressive and variable aerobic exercise ( intensity of 60 to 75 % of initial fitness level , 3-5 times/week and 30-60min / time ) .
METHODS	The diet program includes dietary consultation plus supplementation with a special lunch meal ( 40 % of total energy intake/day ) which aims to reduce the amount of carbohydrate consumption ( 30 % ) .
METHODS	The control and reference groups are advised to maintain their habitual habits during the intervention .
METHODS	The primary outcome measures are HFC , serum metabolomics and gut microbiota composition .
METHODS	The secondary outcome measures include body composition and cytokines .
METHODS	In addition , socio-psychological aspects , social support , physical activity and diet will be performed by means of questionnaire and interview .
CONCLUSIONS	Specific individualized exercise and diet intervention in this study offers a more efficient approach for liver fat reduction and diabetes prevention via modification of gut microbiota composition .
CONCLUSIONS	Besides , the study explores the importance of incorporating fitness assessment and exercise in the management of patients with pre-diabetes and fatty liver disorders .
CONCLUSIONS	If our program is shown to be effective , it will open new strategies to combat these chronic diseases .
BACKGROUND	Current Controlled Trials : ISRCTN42622771 .

###24930817
OBJECTIVE	Obesity and weight-loss are associated with methylation patterns in specific genes , but their effect on Long Interspersed Nuclear Elements ( LINE-1 ) methylation , a measure of global methylation is largely unknown .
METHODS	Three hundred overweight/obese post-menopausal women ( 50-75 years ) were part of a completed , 1-year randomized controlled trial , comparing independent and combined effects of a reduced-calorie weight-loss diet , and exercise program , versus control .
METHODS	DNA was extracted from peripheral blood leukocytes collected at baseline and 12-months , and LINE-1 methylation analyzed by pyrosequencing .
METHODS	Mean changes between groups using generalized estimating equations and examined effects of weight-loss on LINE-1 methylation using stratified analyses ( gained weight/no weight-loss [ N = 84 ] ; < 5 % [ N = 45 ] ; 5 % -10 % [ N = 45 ] ; > 10 % of baseline weight-loss [ N = 126 ] ) within each arm , adjusted by blood cell counts were compared .
METHODS	Associations between LINE-1 methylation and previously measured biomarkers , and anthropometrics were also examined .
RESULTS	No significant difference in LINE-1 methylation levels was detected in any intervention group versus controls .
RESULTS	The magnitude of weight-loss was not associated with LINE-1 methylation at 12-months .
RESULTS	There were no associations between baseline characteristics of participants , or previously measured biomarkers , and LINE-1 methylation .
CONCLUSIONS	Our results suggest that lifestyle changes sufficient to significantly reduce weight over 12-months may not change LINE-1 DNA methylation levels .

###24828537
OBJECTIVE	To compare contrast doses and acquisition times for late gadolinium enhancement ( LGE ) imaging at 3.0 T using gadobenate dimeglumine ( Gd-BOPTA ) in patients with chronic myocardial infarction .
METHODS	Thirty-four patients with chronic myocardial infarction were randomised to 0.10 , 0.15 and 0.20 mmol/kg of Gd-BOPTA .
METHODS	T1-weighted inversion recovery gradient echo sequences were performed at 5 , 10 , 15 and 20 min post-administration of contrast in a 3.0-T scanner .
METHODS	Scar-to-myocardium contrast-to-noise ratio ( CNR ) , scar-to-blood CNR , scar size and image quality were assessed .
RESULTS	Imaging at 5 min was associated with a lower scar-to-blood CNR in comparison to 10 , 15 and 20 min at 0.10 mmol/kg , and in comparison to 15 and 20 min at 0.20 mmol/kg .
RESULTS	At 0.10-mmol / kg , imaging at 5 min yielded smaller infarct sizes in comparison to 15 and 20 min .
RESULTS	Finally , at 0.20-mmol / kg , imaging at 5 min was associated with poorer image quality in comparison to later times .
CONCLUSIONS	In LGE imaging at 3.0 T , low doses of Gd-BOPTA perform equally well as higher doses .
CONCLUSIONS	Early acquisition ( 5 min ) is associated with lower infarct sizes and image quality .
CONCLUSIONS	Studies with sufficient diagnostic quality can be obtained after 10 min using 0.10 mmol/kg Gd-BOPTA .
CONCLUSIONS	Good performance of low Gd-BOPTA doses for LGE imaging at 3.0 T. Imaging at 5 min yields lower contrast , infarct sizes and image quality .
CONCLUSIONS	Diagnostic quality can be obtained after 10 min using 0.10-mmol / kg Gd-BOPTA .

###25271015
OBJECTIVE	Plant stanol esters lower serum low-density lipoprotein ( LDL ) - cholesterol ( LDL-C ) , but responses between individuals vary widely .
OBJECTIVE	As the ability of subjects to respond to acute dietary challenges may reflect the flexibility to adapt to changes on the longer term , we related subjects ' acute postprandial metabolic changes to changes in serum lipoproteins after chronic intake of plant stanol esters .
METHODS	In a double-blind crossover design , 20 healthy subjects received in random order a high-fat shake enriched with or without plant stanol esters ( 4 g ) .
METHODS	Blood samples were taken during 4 h to examine lipid , glucose and lipoprotein profiles .
METHODS	Two subjects dropped out .
METHODS	For the 3 weeks after this postprandial test , the subjects who received the shake with plant stanol esters continued the consumption of plant stanol-enriched ( 3g/day ) margarine and subjects receiving the control shake in the postprandial test consumed for the next 3 weeks a control margarine .
METHODS	After the washout period , subjects received the other shake and margarines .
RESULTS	The margarine enriched with plant stanol esters lowered concentrations of total cholesterol by 7.3 % ( P < 0.01 ) , LDL-C by 9.5 % ( P < 0.01 ) and apoB100 by 8.6 % ( P < 0.01 ) .
RESULTS	Furthermore , particle concentrations of total very low-density lipoprotein ( VLDL ) , small VLDL and large LDL were reduced by 26.6 % ( P = 0.02 ) , 27.6 % ( P = 0.02 ) and 12.3 % ( P = 0.04 ) , respectively .
RESULTS	Plant stanol esters did not affect parameters related to lipid and glucose metabolism during the postprandial phase .
RESULTS	However , the incremental area under the curve ( iAUC ) of the postprandial glucose concentration after consuming the control shake correlated positively with changes in fasting concentrations of total cholesterol , LDL-C , apoB100 , total VLDL , small VLDL and intermediate-density lipoprotein after 3 weeks .
CONCLUSIONS	A single dose of plant stanol esters does not change postprandial lipid and lipoprotein profiles .
CONCLUSIONS	However , postprandial glucose responses may predict the effects of chronic plant stanol ester consumption .

###24355800
OBJECTIVE	This study sought to evaluate the diagnostic performance of multiparametric cardiovascular magnetic resonance ( CMR ) for detecting cardiac allograft vasculopathy ( CAV ) using contemporary invasive epicardial artery and microvascular assessment techniques as reference standards , and to compare the performance of CMR with that of angiography .
BACKGROUND	CAV continues to limit the long-term survival of heart transplant recipients .
BACKGROUND	Coronary angiography has a Class I recommendation for CAV surveillance and annual or biannual surveillance angiography is performed routinely inmost centers .
METHODS	All transplant recipients referred for surveillance angiography at a single UK center over a 2-year period were prospectively screened for study eligibility .
METHODS	Patients prospectively underwent coronary angiography followed by coronary intravascular ultrasound , fractional flow reserve , and index of microcirculatory resistance .
METHODS	Within 1 month , patients underwent multiparametric CMR , including assessment of regional and global ventricular function , absolute myocardial blood flow quantification , and myocardial tissue characterization .
METHODS	In addition , 10 healthy volunteers underwent CMR .
RESULTS	Forty-eight patients were recruited , median 7.1 years ( interquartile range : 4.6 to 10.3 years ) since transplantation .
RESULTS	The CMR myocardial perfusion reserve was the only independent predictor of both epicardial ( = -0.57 , p < 0.001 ) and microvascular disease ( = -0.60 , p < 0.001 ) on stepwise multivariable regression .
RESULTS	The CMRmyocardial perfusion reserve significantly outperformed angiography for detecting moderate CAV ( area underthe curve , 0.89 [ 95 % confidence interval ( CI ) : 0.79 to 1.00 ] vs. 0.59 [ 95 % CI : 0.42 to 0.77 ] , p = 0.01 ) and severe CAV ( area under the curve , 0.88 [ 95 % CI : 0.78 to 0.98 ] vs. 0.67 [ 95 % CI : 0.52 to 0.82 ] , p = 0.05 ) .
CONCLUSIONS	CAV , including epicardial and microvascular components , can be detected more accurately using noninvasive CMR-based absolute myocardial blood flow assessment than with invasive coronary angiography , the current clinical surveillance technique .

###25511324
BACKGROUND	Acute lower respiratory infections ( ALRI ) are a leading cause of death among children .
BACKGROUND	Low birthweight is prevalent in South Asia and associated with increased risks of mortality , and morbidity , high levels of indoor household air pollution caused by open burning of biomass fuels are common and associated with high rates of ALRI and low birthweight .
BACKGROUND	Alternative stove designs that burn biomass fuel more efficiently have been proposed as one method for reducing these high exposures and lowering rates of these disorders .
BACKGROUND	We designed two randomized trials to test this hypothesis .
METHODS	We conducted a pair of community-based , randomized trials of alternative cookstove installation in a rural district in southern Nepal .
METHODS	Phase one was a cluster randomized , modified step-wedge design using an alternative biomass stove with a chimney .
METHODS	A pre-installation period of morbidity assessment and household environmental assessment was conducted for six months in all households .
METHODS	This was followed by a one year step-wedge phase with 12 monthly steps for clusters of households to receive the alternative stove .
METHODS	The timing of alternative stove introduction was randomized .
METHODS	This step-wedge phase was followed in all households by another six month follow-up phase .
METHODS	Eligibility criteria for phase one included household informed consent , the presence of a married woman of reproductive age ( 15-30 yrs ) or a child < 36 months .
METHODS	Children were followed until 36 months of age or the end of the trial .
METHODS	Pregnancies were identified and followed until completion or end of the trial .
METHODS	Phase two was an individually randomized trial of the same alternative biomass stove versus liquid propane gas stove in a subset of households that participated in phase one .
METHODS	Follow-up for phase two was 12 months following stove installation .
METHODS	Eligibility criteria included the same components as phase one except children were only enrolled for morbidity follow-up if they were less than 24 months.The primary outcomes included : incidence of ALRI in children and birthweight .
CONCLUSIONS	We presented the design and methods of two randomized trials of alternative cookstoves on rates of ALRI and birthweight .
BACKGROUND	Clinicaltrials.gov ( NCT00786877 , Nov. 5 , 2008 ) .

###24220602
BACKGROUND	Patients with atrial fibrillation ( AF ) are at significantly increased risk of stroke .
BACKGROUND	Oral anticoagulants ( OACs ) substantially reduce this risk , with gains seen across the spectrum of baseline risk .
BACKGROUND	Despite the benefit to patients , OAC prescribing remains suboptimal in the United Kingdom ( UK ) .
BACKGROUND	We will investigate whether an automated software system , operating within primary care electronic medical records , can improve the management of AF by identifying patients eligible for OAC therapy and increasing uptake of this treatment .
METHODS	We will conduct a cluster randomised controlled trial , involving general practices using the Egton Medical Information Systems ( EMIS ) Web clinical system .
METHODS	We will randomise practices to use an electronic software tool or to continue with usual care .
METHODS	The tool will a ) produce ( and continually refresh ) a list of patients with AF who are eligible for OAC therapy -- practices will invite these patients to discuss therapy at the start of the trial -- and b ) generate electronic screen reminders in the medical records of those eligible , appearing throughout the trial .
METHODS	The software will run for 6 months in 23 intervention practices .
METHODS	A total of 23 control practices will manage their AF register in line with the usual care offered .
METHODS	The primary outcome is change in proportion of eligible patients with AF who have been prescribed OAC therapy after six months .
METHODS	Secondary outcomes are incidence of stroke , transient ischaemic attack , other major thromboembolism , major haemorrhage and reports of inappropriate OAC prescribing in the data collection sample -- those deemed eligible for OACs .
METHODS	We will conduct a process evaluation in parallel with the randomised trial .
METHODS	We will use qualitative methods to examine patient and practitioner views of the intervention and its impact on primary care practice , including its time implications .
CONCLUSIONS	AURAS-AF will investigate whether a simple intervention , using electronic primary care records , can improve OAC uptake in a high risk group for stroke .
CONCLUSIONS	Given previous concerns about safety , especially surrounding inappropriate prescribing , we will also examine whether electronic reminders safely impact care in this clinical area .
BACKGROUND	http://ISRCTN 55722437 .

###25129395
BACKGROUND	The novel isoxazoline molecule fluralaner provides 12weeks activity against fleas and 8 to 12weeks against tick infestations according to label claims .
METHODS	This blinded , multi-center study in client-owned dogs evaluated the flea control provided by a single oral fluralaner treatment ( 25-56mg / kg ; Bravecto , Merck Animal Health ) compared to a control group administered three oral spinosad ( 30 - 60mg/kg ; Comfortis , Elanco ) treatments at 4-week intervals together with an amitraz collar ( 9 % , Preventic , Virbac ) .
METHODS	Households were randomized ( 3:1 ratio ) to either fluralaner ( 224 dogs , 118 households ) or control ( 70 dogs , 39 households ) .
METHODS	Within households , one primary dog with at least 10 live fleas at enrollment was randomly selected for whole body flea counts every 4weeks through Week 12 ; all dogs were followed for safety until Week 12 .
METHODS	Fluralaner dogs received two additional doses at Weeks 12 and 24 for further safety and palatability observations through Week 26 .
RESULTS	Geometric mean flea count reductions from baseline for the fluralaner group at Weeks 4 , 8 , and 12 were 99.7 % , 99.8 % , and 99.8 % , respectively ; and 96.1 % , 99.5 % , and 99.6 % for the spinosad controls .
RESULTS	Percentages of flea-free primary dogs at Weeks 4 , 8 , and 12 were 91.1 % , 95.4 % , and 95.3 % for the fluralaner group ; and 44.7 % , 88.2 % , and 84.4 % for the controls ; the differences were significant at Weeks 4 ( P < 0.0001 ) and 12 ( P = 0.0370 ) .
RESULTS	Improvements in veterinarian assessed flea allergy dermatitis ( FAD ) were observed in both groups .
RESULTS	Fluralaner tablets were accepted free choice in over 90 % of doses .
RESULTS	The most common adverse event was vomiting , occurring in 7.1 % of the fluralaner group and 14.3 % of the controls .
RESULTS	No treatment related serious adverse events were reported .
CONCLUSIONS	A single treatment of dogs with the palatable fluralaner flavored chewable tablet provides a safe and effective option for 12weeks of flea control at least equivalent to that of 3 sequential treatments with spinosad tablets .
CONCLUSIONS	Linked to the high level of flea control was a substantial alleviation of associated signs of FAD .

###25087182
BACKGROUND	Asparaginase and steroids can cause hypertriglyceridaemia in children with acute lymphoblastic leukaemia ( ALL ) .
BACKGROUND	There are no guidelines for screening or management of patients with severe hypertriglyceridaemia ( > 1000mg/dL ) during ALL therapy .
METHODS	Fasting lipid profiles were obtained prospectively at four time-points for 257 children consecutively enrolled on a frontline ALL study .
METHODS	Risk factors were evaluated by the exact chi-square test .
METHODS	Details of adverse events and management of hypertriglyceridaemia were extracted retrospectively .
RESULTS	Eighteen of 257 ( 7 % ) patients developed severe hypertriglyceridaemia .
RESULTS	Older age and treatment with higher doses of asparaginase and steroids on the standard/high-risk arm were significant risk factors .
RESULTS	Severe hypertriglyceridaemia was not associated with pancreatitis after adjustment for age and treatment arm or with osteonecrosis after adjustment for age .
RESULTS	However , patients with severe hypertriglyceridaemia had a 2.5-3 times higher risk of thrombosis compared to patients without , albeit the difference was not statistically significant .
RESULTS	Of the 30 episodes of severe hypertriglyceridaemia in 18 patients , seven were managed conservatively while the others with pharmacotherapy .
RESULTS	Seventeen of 18 patients continued to receive asparaginase and steroids .
RESULTS	Triglyceride levels normalised after completion of ALL therapy in all 12 patients with available measurements .
CONCLUSIONS	Asparaginase - and steroid-induced transient hypertriglyceridaemia can be adequately managed with dietary modifications and close monitoring without altering chemotherapy .
CONCLUSIONS	Patients with severe hypertriglyceridaemia were not at increased risk of adverse events , with a possible exception of thrombosis .
CONCLUSIONS	The benefit of pharmacotherapy in decreasing symptoms and potential complications requires further investigation .

###25419703
BACKGROUND	We examined electronic cigarette ( EC ) use , correlates of use , and associated changes in smoking behavior among smokers with serious mental illness in a clinical trial .
METHODS	Adult smokers were recruited during acute psychiatric hospitalization ( N = 956 , 73 % enrollment among approached smokers ) in the San Francisco Bay Area between 2009-2013 .
METHODS	At baseline , participants averaged 17 ( SD = 10 ) cigarettes per day for 19 ( SD = 14 ) years ; 24 % intended to quit smoking in the next month .
METHODS	Analyses examined frequency and correlates of EC use reported over the 18-month trial and changes in smoking behavior by EC use status .
RESULTS	EC use was 11 % overall , and by year of enrollment , increased from 0 % in 2009 to 25 % in 2013 .
RESULTS	In multiple logistic regression , the likelihood of EC use was significantly greater with each additional year of recruitment , for those aged 18-26 , and for those in the preparation versus precontemplation stage of change , and unlikely among Hispanic participants .
RESULTS	EC use was unrelated to gender , psychiatric diagnosis , and measures of tobacco dependence at baseline .
RESULTS	Further , over the 18-month trial , EC use was not associated with changes in smoking status or , among continued smokers , with reductions in cigarettes per day .
CONCLUSIONS	Within a clinical trial with smokers with serious mental illness , EC use increased over time , particularly among younger adults and those intending to quit tobacco .
CONCLUSIONS	EC use was unrelated to changes in smoking .
CONCLUSIONS	The findings are of clinical interest and warrant further study .

###25174240
OBJECTIVE	We hypothesized that showing native Spanish speaking parents , a Spanish video explaining the risks and benefits of anesthesia within two weeks prior to surgery would reduce parental anxiety .
METHODS	Subjects were randomly assigned to video-group or non-video-group .
METHODS	Both groups completed PPUS , STAIT and APAIS tests before and after viewing the videos .
METHODS	Parents repeated the same three tests before the operation on the day of the surgery .
RESULTS	The results revealed a decrease in 3 points on the APAIS assessment in the non-video-group compared to 5.8 points decrease in the video-group .
RESULTS	PPUS assessment revealed an average 1.25 points increase in the non-video-group compared to 11 points decrease in video-group .
RESULTS	Due to the extremely low sample size , the statistical significance of the findings can not be verified by statistical methods .
CONCLUSIONS	Hispanic parents who viewed the preanesthesia Spanish-video had lower levels of anxiety compared to those who did not watch the video .

###25675317
BACKGROUND	The aim of this study was to examine the influence of aftercare sessions in a psychosomatic rehabilitation on the sociomedical development .
BACKGROUND	The after care group was compared with treatment as usual .
METHODS	In a prospective , controlled and randomized longitudinal study data about the state of health and job status were assessed at 4 measured time points .
METHODS	As an indicator of the sociomedical development the current employment status was used .
METHODS	Aftercare treatment ( n = 139 ) included 2-4 interview contacts ( via telephone or face-to-face ) within the first 3 months after discharge from inpatient psychosomatic rehabilitation .
METHODS	A control group ( n = 62 ) received treatment as usual .
RESULTS	3 and 9 months after the end of rehabilitation participants in the aftercare showed a better sociomedical development than the participants in the control condition .

###24784879
OBJECTIVE	To determine the effectiveness of helmet therapy for positional skull deformation compared with the natural course of the condition in infants aged 5-6 months .
METHODS	Pragmatic , single blinded , randomised controlled trial ( HEADS , HElmet therapy Assessment in Deformed Skulls ) nested in a prospective cohort study .
METHODS	29 paediatric physiotherapy practices ; helmet therapy was administered at four specialised centres .
METHODS	84 infants aged 5 to 6 months with moderate to severe skull deformation , who were born after 36 weeks of gestation and had no muscular torticollis , craniosynostosis , or dysmorphic features .
METHODS	Participants were randomly assigned to helmet therapy ( n = 42 ) or to natural course of the condition ( n = 42 ) according to a randomisation plan with blocks of eight .
METHODS	Six months of helmet therapy compared with the natural course of skull deformation .
METHODS	In both trial arms parents were asked to avoid any ( additional ) treatment for the skull deformation .
METHODS	The primary outcome was change in skull shape from baseline to 24 months of age assessed using plagiocephalometry ( anthropometric measurement instrument ) .
METHODS	Change scores for plagiocephaly ( oblique diameter difference index ) and brachycephaly ( cranioproportional index ) were each included in an analysis of covariance , using baseline values as the covariate .
METHODS	Secondary outcomes were ear deviation , facial asymmetry , occipital lift , and motor development in the infant , quality of life ( infant and parent measures ) , and parental satisfaction and anxiety .
METHODS	Baseline measurements were performed in infants aged between 5 and 6 months , with follow-up measurements at 8 , 12 , and 24 months .
METHODS	Primary outcome assessment at 24 months was blinded .
RESULTS	The change score for both plagiocephaly and brachycephaly was equal between the helmet therapy and natural course groups , with a mean difference of -0.2 ( 95 % confidence interval -1.6 to 1.2 , P = 0.80 ) and 0.2 ( -1.7 to 2.2 , P = 0.81 ) , respectively .
RESULTS	Full recovery was achieved in 10 of 39 ( 26 % ) participants in the helmet therapy group and 9 of 40 ( 23 % ) participants in the natural course group ( odds ratio 1.2 , 95 % confidence interval 0.4 to 3.3 , P = 0.74 ) .
RESULTS	All parents reported one or more side effects .
CONCLUSIONS	Based on the equal effectiveness of helmet therapy and skull deformation following its natural course , high prevalence of side effects , and high costs associated with helmet therapy , we discourage the use of a helmet as a standard treatment for healthy infants with moderate to severe skull deformation .
BACKGROUND	Current Controlled Trials ISRCTN18473161 .

###24467875
BACKGROUND	PAD is a disabling , chronic condition of the lower extremities that affects approximately 8 million people in the United States .
BACKGROUND	The purpose of this study was to determine whether an innovative home-based walking exercise program for patients with peripheral artery disease ( PAD ) improves self-efficacy for walking , desire for physical competence , satisfaction for physical functioning , social functioning , and acceptance of PAD related pain and discomfort .
METHODS	The design was a 6-month randomized controlled clinical trial of 194 patients with PAD .
METHODS	Participants were randomized to 1 of 2 parallel groups : a home-based group-mediated cognitive behavioral walking intervention or an attention control condition .
RESULTS	Of the 194 participants randomized , 178 completed the baseline and 6-month follow-up visit .
RESULTS	The mean age was 70.66 ( 9.44 ) and was equally represented by men and women .
RESULTS	Close to half of the cohort was African American .
RESULTS	Following 6-months of treatment , the intervention group experienced greater improvement on self-efficacy ( p = .0008 ) , satisfaction with functioning ( p = .0003 ) , pain acceptance ( p = .0002 ) , and social functioning ( p = .0008 ) than the control group ; the effects were consistent across a number of potential moderating variables .
RESULTS	Change in these outcomes was essentially independent of change in 6-minute walk performance .
BACKGROUND	[ ClinicalTrials.gov Identifier : NCT00693940 ] .

###24613816
OBJECTIVE	To test whether altered radiation fractionation schemes ( hyperfractionation [ HFX ] , accelerated fractionation , continuous [ AFX-C ] , and accelerated fractionation with split [ AFX-S ] ) improved local-regional control ( LRC ) rates for patients with squamous cell cancers ( SCC ) of the head and neck when compared with standard fractionation ( SFX ) of 70 Gy .
METHODS	Patients with stage III or IV ( or stage II base of tongue ) SCC ( n = 1076 ) were randomized to 4 treatment arms : ( 1 ) SFX , 70 Gy/35 daily fractions/7 weeks ; ( 2 ) HFX , 81.6 Gy/68 twice-daily fractions/7 weeks ; ( 3 ) AFX-S , 67.2 Gy/42 fractions/6 weeks with a 2-week rest after 38.4 Gy ; and ( 4 ) AFX-C , 72 Gy/42 fractions/6 weeks .
METHODS	The 3 experimental arms were to be compared with SFX .
RESULTS	With patients censored for LRC at 5 years , only the comparison of HFX with SFX was significantly different : HFX , hazard ratio ( HR ) 0.79 ( 95 % confidence interval 0.62-1 .00 ) , P = .05 ; AFX-C , 0.82 ( 95 % confidence interval 0.65-1 .05 ) , P = .11 .
RESULTS	With patients censored at 5 years , HFX improved overall survival ( HR 0.81 , P = .05 ) .
RESULTS	Prevalence of any grade 3 , 4 , or 5 toxicity at 5 years ; any feeding tube use after 180 days ; or feeding tube use at 1 year did not differ significantly when the experimental arms were compared with SFX .
RESULTS	When 7-week treatments were compared with 6-week treatments , accelerated fractionation appeared to increase grade 3 , 4 or 5 toxicity at 5 years ( P = .06 ) .
RESULTS	When the worst toxicity per patient was considered by treatment only , the AFX-C arm seemed to trend worse than the SFX arm when grade 0-2 was compared with grade 3-5 toxicity ( P = .09 ) .
CONCLUSIONS	At 5 years , only HFX improved LRC and overall survival for patients with locally advanced SCC without increasing late toxicity .

###25132119
OBJECTIVE	To identify the metabolic determinants of type 2 diabetes non-remission status after bariatric surgery at 12 and 24 months .
METHODS	A total of 40 adults [ mean sd body mass index 36 3 kg/m ( 2 ) , age 48 9 years , glycated haemoglobin ( HbA1c ) 9.7 2 % ) undergoing bariatric surgery [ Roux-en-Y gastric bypass ( RYGB ) or sleeve gastrectomy ( SG ) ] were enrolled in the present study , the Surgical Treatment and Medication Potentially Eradicate Diabetes Efficiently ( STAMPEDE ) trial .
METHODS	Type 2 diabetes remission was defined as HbA1c < 6.5 % and fasting glucose < 126 mg/dl ( i.e. < 7 mmol/l ) without antidiabetic medication .
METHODS	Indices of insulin secretion and sensitivity were calculated from plasma glucose , insulin and C-peptide values during a 120-min mixed-meal tolerance test .
METHODS	Body fat , incretins ( glucagon-like polypeptide-1 , gastric inhibitory peptide , ghrelin ) and adipokines [ adiponectin , leptin , tumour necrosis factor - , high-sensitivity C-reactive protein ( hs-CRP ) ] were also assessed .
RESULTS	At 24 months , 37 patients had available follow-up data ( RYGB , n = 18 ; SG , n = 19 ) .
RESULTS	Bariatric surgery induced type 2 diabetes remission rates of 40 and 27 % at 12 and 24 months , respectively .
RESULTS	Total fat/abdominal fat loss , insulin secretion , insulin sensitivity and - cell function ( C-peptide0-120 / glucose0-120 Matsuda index ) improved more in those with remission at 12 and 24 months than in those without remission .
RESULTS	Incretin levels were unrelated to type 2 diabetes remission , but , compared with those without remission , hs-CRP decreased and adiponectin increased more in those with remission .
RESULTS	Only baseline adiponectin level predicted lower HbA1c levels at 12 and 24 months , and elevated adiponectin correlated with enhanced - cell function , lower triglyceride levels and fat loss .
CONCLUSIONS	Smaller rises in adiponectin level , a mediator of insulin action and adipose mass , characterize type 2 diabetes non-remission up to 2 years after bariatric surgery .
CONCLUSIONS	Adjunctive strategies promoting greater fat loss and/or raising adiponectin may be key to achieving higher type 2 diabetes remission rates after bariatric surgery .

###25149298
OBJECTIVE	To evaluate and compare novel robotic guidance and manual approaches based on procedural accuracy , procedural time , procedural performance , image quality as well as patient dose during image-guided microwave thermoablation .
METHODS	The study was prospectively performed between June 2013 and December 2013 using 70 patients .
METHODS	Forty randomly selected patients ( group1 ) were treated with manual guidance and 30 patients ( group2 ) were treated using a novel robotic guidance .
METHODS	Parameters evaluated were procedural accuracy , total procedural time , procedural performance , quantitative/qualitative image quality and patient dose .
METHODS	Two-sided Student 's t test and Wilcoxon rank-sum test were used to test the significance of the data and p values less than 0.05 were considered statistically significant .
RESULTS	Accuracy parameters were significantly higher in group2 ( all p < 0.05 ) .
RESULTS	Total procedural time showed a mean time difference of 3min ( group2 > group1 ; p = 0.0008 ) .
RESULTS	Volume CT dose index and dose-length product were significantly lower for group2 compared to group1 ( all p < 0.05 ) for CT fluoroscopy imaging .
RESULTS	Total procedural performance score was higher for group2 compared to group1 ( p = 0.0001 ) .
RESULTS	Image quality parameters were insignificant between examined groups .
CONCLUSIONS	The novel robotic guided approach improved the accuracy of targeting the target tumour , reduced patient dose and increased procedural performance ( which influences the procedural safety ) during ablation .
CONCLUSIONS	Few reports are available in the literature regarding robotic-assisted liver microwave ablation .
CONCLUSIONS	The robotic guided approach improved accuracy of localizing the target tumour .
CONCLUSIONS	Radiation dose on patients was reduced with the robotic guidance .
CONCLUSIONS	Numbers of insertions and readjustments were reduced , lowering chances of complications .

###24360745
BACKGROUND	The relationships between pain , stress and anxiety , and their effect on burn wound re-epithelialization have not been well explored to-date .
BACKGROUND	The aim of this study was to investigate the effect of the Ditto ( a hand-held electronic medical device providing procedural preparation and distraction ) intervention on re-epithelialization rates in acute pediatric burns .
METHODS	From August 2011 to August 2012 , children ( 4-12 years ) with an acute burn presenting to the Royal Children 's Hospital , Brisbane , Australia fulfilled the study requirements and were randomized to [ 1 ] Ditto intervention or [ 2 ] standard practice .
METHODS	Burn re-epithelialization , pain intensity , anxiety and stress measures were obtained at every dressing change until complete wound re-epithelialization .
RESULTS	One hundred and seventeen children were randomized and 75 children were analyzed ( n = 40 standard group ; n = 35 Ditto group ) .
RESULTS	Inability to predict wound management resulted in 42 participants no longer meeting the eligibility criteria .
RESULTS	Wounds in the Ditto intervention group re-epithelialized faster than the standard practice group ( -2.14 days ( CI : -4.38 to 0.10 ) , p-value = 0.061 ) , and significantly faster when analyses were adjusted for mean burn depth ( -2.26 days ( CI : -4.48 to -0.04 ) , p-value = 0.046 ) .
RESULTS	Following procedural preparation at the first change of dressing , the Ditto group reported lower pain intensity scores ( -0.64 ( CI : -1.28 , 0.01 ) p = 0.052 ) and lower anxiety ratings ( -1.79 ( CI : -3.59 , 0.01 ) p = 0.051 ) .
RESULTS	At the second and third dressing removals average pain ( FPS-R and FLACC ) and anxiety scores ( VAS-A ) were at least one point lower when Ditto intervention was received .
CONCLUSIONS	The Ditto procedural preparation and distraction device is a useful tool alongside pharmacological intervention to improve the rate of burn re-epithelialization and manage pain and anxiety during burn wound care procedures .

###24222839
OBJECTIVE	Rapid heart rate lowering may be attractive in acute ST-segment elevation myocardial infarction ( STEMI ) .
OBJECTIVE	Accordingly we studied the effect of intravenous ivabradine on heart rate in this setting .
RESULTS	This was a multicenter randomized double-blind placebo-controlled trial : patients aged 40-80 years were randomized after successful primary percutaneous coronary intervention ( PCI ) performed within 6 h of STEMI symptom onset .
RESULTS	Patients were in sinus rhythm and with heart rate > 80 bpm and systolic blood pressure > 90 mm Hg .
RESULTS	They were randomly assigned ( 2:1 ratio ) to intravenous ivabradine ( n = 82 ) ( 5 mg bolus over 30 s , followed by 5 mg infusion over 8 h ) or matching placebo ( n = 42 ) .
RESULTS	The primary outcome measure was heart rate and blood pressure .
RESULTS	In both groups , heart rate was reduced over 8 h , with a faster and more marked decrease on ivabradine than placebo ( 22.2 1.3 vs 8.9 1.8 bpm , p < 0.0001 ) .
RESULTS	After treatment discontinuation , heart rate was similar in both groups .
RESULTS	Throughout the study , there was no difference in blood pressure between groups .
RESULTS	There was no difference in cardiac biomarkers ( creatine kinase ( CK-MB ) , troponin T and troponin I ) .
RESULTS	On echocardiography performed at baseline and post treatment ( median 1.16 days ) , final left ventricular volumes were lower in the ivabradine group both for left ventricular end-diastolic volume ( LVEDV ) ( 87.1 28.2 vs 117.8 21.4 ml , p = 0.01 ) and left ventricular end-systolic volume ( LVESV ) ( 42.5 19.0 versus 59.1 11.3 ml , p = 0.03 ) without differences in volume change or left ventricular ejection fraction .
CONCLUSIONS	This pilot study shows that intravenous ivabradine may be used safely to slow the heart rate in STEMI .
CONCLUSIONS	Further studies are needed to characterize its effect on infarct size , left ventricular function and clinical outcomes in this population .

###25321149
OBJECTIVE	The Affordable Care Act provides funding for home-visiting programs to reduce health care disparities , despite limited evidence that existing programs can overcome implementation and evaluation challenges with at-risk populations .
OBJECTIVE	The authors report 36-month outcomes of the paraprofessional-delivered Family Spirit home-visiting intervention for American Indian teen mothers and children .
METHODS	Expectant American Indian teens ( N = 322 , mean age = 18.1 years ) from four southwestern reservation communities were randomly assigned to the Family Spirit intervention plus optimized standard care or optimized standard care alone .
METHODS	Maternal and child outcomes were evaluated at 28 and 36 weeks gestation and 2 , 6 , 12 , 18 , 24 , 30 , and 36 months postpartum .
RESULTS	At baseline the mothers had high rates of substance use ( > 84 % ) , depressive symptoms ( > 32 % ) , dropping out of school ( > 57 % ) , and residential instability ( 51 % ) .
RESULTS	Study retention was 83 % .
RESULTS	From pregnancy to 36 months postpartum , mothers in the intervention group had significantly greater parenting knowledge ( effect size = 0.42 ) and parental locus of control ( effect size = 0.17 ) , fewer depressive symptoms ( effect size = 0.16 ) and externalizing problems ( effect size = 0.14 ) , and lower past month use of marijuana ( odds ratio = 0.65 ) and illegal drugs ( odds ratio = 0.67 ) .
RESULTS	Children in the intervention group had fewer externalizing ( effect size = 0.23 ) , internalizing ( effect size = 0.23 ) , and dysregulation ( effect size = 0.27 ) problems .
CONCLUSIONS	The paraprofessional home-visiting intervention promoted effective parenting , reduced maternal risks , and improved child developmental outcomes in the U.S. population subgroup with the fewest resources and highest behavioral health disparities .
CONCLUSIONS	The methods and results can inform federal efforts to disseminate and sustain evidence-based home-visiting interventions in at-risk populations .

###25252602
BACKGROUND	In nonrandomized trials , neoadjuvant treatment was reported to prolong survival in patients with pancreatic cancer .
BACKGROUND	As neoadjuvant chemoradiation is established for the treatment of rectal cancer we examined the value of neoadjuvant chemoradiotherapy in pancreatic cancer in a randomized phase II trial .
BACKGROUND	Radiological staging defining resectability was basic information prior to randomization in contrast to adjuvant therapy trials resting on pathological staging .
METHODS	Patients with resectable adenocarcinoma of the pancreatic head were randomized to primary surgery ( Arm A ) or neoadjuvant chemoradiotherapy followed by surgery ( Arm B ) , which was followed by adjuvant chemotherapy in both arms .
METHODS	A total of 254 patients were required to detect a 4.33-month improvement in median overall survival ( mOS ) .
RESULTS	The trial was stopped after 73 patients ; 66 patients were eligible for analysis .
RESULTS	Twenty nine of 33 allocated patients received chemoradiotherapy .
RESULTS	Radiotherapy was completed in all patients .
RESULTS	Chemotherapy was changed in 3 patients due to toxicity .
RESULTS	Tumor resection was performed in 23 vs. 19 patients ( A vs. B ) .
RESULTS	The R0 resection rate was 48 % ( A ) and 52 % ( B , P = 0.81 ) and ( y ) pN0 was 30 % ( A ) vs. 39 % ( B , P = 0.44 ) , respectively .
RESULTS	Postoperative complications were comparable in both groups .
RESULTS	mOS was 14.4 vs. 17.4 months ( A vs. B ; intention-to-treat analysis ; P = 0.96 ) .
RESULTS	After tumor resection , mOS was 18.9 vs. 25.0 months ( A vs. B ; P = 0.79 ) .
CONCLUSIONS	This worldwide first randomized trial for neoadjuvant chemoradiotherapy in pancreatic cancer showed that neoadjuvant chemoradiation is safe with respect to toxicity , perioperative morbidity , and mortality .
CONCLUSIONS	Nevertheless , the trial was terminated early due to slow recruiting and the results were not significant .
CONCLUSIONS	ISRCTN78805636 ; NCT00335543 .

###25506618
BACKGROUND	Balance and functional abilities are controlled by both sides of the body .
BACKGROUND	The role of nonparetic side has never been explored for such skills .
OBJECTIVE	The objective of the present study was to examine the effect of a motor therapy program primarily involving the nonparetic side on balance and function in chronic stroke .
METHODS	A randomized controlled , double blinded trial was conducted on 39 poststroke hemiparetic subjects ( 21 , men ; mean age , 42 years ; mean poststroke duration , 13 months ) .
METHODS	They were randomly divided into the experimental group ( n = 20 ) and control group ( n = 19 ) .
METHODS	The participants received either motor therapy focusing on the nonparetic side along with the conventional program or conventional program alone for 8 weeks ( 3 session/week , 60 minutes each ) .
METHODS	The balance ability was assessed using Berg Balance Scale ( BBS ) and Functional Reach Test ( FRT ) while the functional performance was measured by Barthel Index ( BI ) .
RESULTS	After intervention , the experimental group exhibited significant ( P < 0.05 ) change on BBS ( 5.65 versus 2.52 ) and BI ( 12.75 versus 2.16 ) scores in comparison to the control group .
CONCLUSIONS	The motor therapy program incorporating the nonparetic side along with the affected side was found to be effective in enhancing balance and function in stroke .

###25022131
OBJECTIVE	To compare the efficacy differences between needle-knife therapy and acupuncture-cupping for treatment of cervical spondylosis ( CS ) of cervical type .
METHODS	Sixty cases of CS were randomly divided into a needle-knife group ( 30 cases ) and an acupuncture-cupping group ( 30 cases ) .
METHODS	The needle-knife therapy was applied at points among superior nuchal line of occipital bone , bilateral neck muscle , neck centerline , trapezius and medial border scapula for only once .
METHODS	In the acupuncture-cupping group , acupuncture was applied at Fengchi ( GB 20 ) , Fengfu ( GV 16 ) , Tianzhu ( BL 10 ) , Dazhui ( GV 14 ) , Jianjing ( GB 21 ) , Jiaji ( Ex-B2 , from C4 to C6 ) , Houxi ( SI 3 ) and Ashi point , followed by cupping on local skin , once every other day for totally six times .
METHODS	The score of neck stiffness and visual analogue scale ( VAS ) were observed before and after treatment , in follow-up of 1 , 3 and 6 months after treatment in the two groups , and the efficacy was compared .
RESULTS	In the needle-knife group , 9 cases were cured , 12 cases were markedly effective , 8 cases were effective and 1 case was failed ; the total effective rate was 96.7 % ( 29/30 ) and the cured and markedly effective rate was 70.0 % ( 21/30 ) .
RESULTS	In the acupuncture-cupping group , 8 cases were cured , 9 cases were markedly effective , 11 cases were effective and 2 cases were failed ; the total effective rate was 93.3 % ( 28/30 ) and the cured and markedly effective rate was 56.7 % ( 17/30 ) .
RESULTS	The difference of total effective rate in the two groups was not statistically significant ( P > 0.05 ) , but the cured and markedly effective rate of needle-knife group was significantly superior to that of acupuncture-cupping group ( P < 0.05 ) .
RESULTS	The needle-knife therapy was significantly superior to acupuncture-cupping on improvement of neck stiffness in the follow-up of 1 , 3 , 6 months after treatment ( P < 0.05 , P < 0.001 ) ; both treatments were effective on relief of neck pain , but the needle-knife group had better effects in the follow-up of 3 and 6 months after treatment compared with acupuncture-cupping group ( both P < 0.01 ) .
CONCLUSIONS	The needle-knife therapy has better effects on neck stiffness and pain relief than acupuncture-cupping , and it is more treatment time saving .

###24938769
BACKGROUND	We devised a randomised controlled trial to evaluate the effectiveness and efficiency of an intervention based on case management care for frequent emergency department users .
BACKGROUND	The aim of the intervention is to reduce such patients ' emergency department use , to improve their quality of life , and to reduce costs consequent on frequent use .
BACKGROUND	The intervention consists of a combination of comprehensive case management care and standard emergency care .
BACKGROUND	It uses a clinical case management model that is patient-identified , patient-directed , and developed to provide high intensity services .
BACKGROUND	It provides a continuum of hospital - and community-based patient services , which include clinical assessment , outreach referral , and coordination and communication with other service providers .
METHODS	We aim to recruit , during the first year of the study , 250 patients who visit the emergency department of the University Hospital of Lausanne , Switzerland .
METHODS	Eligible patients will have visited the emergency department 5 or more times during the previous 12 months .
METHODS	Randomisation of the participants to the intervention or control groups will be computer generated and concealed .
METHODS	The statistician and each patient will be blinded to the patient 's allocation .
METHODS	Participants in the intervention group ( N = 125 ) , additionally to standard emergency care , will receive case management from a team , 1 ( ambulatory care ) to 3 ( hospitalization ) times during their stay and after 1 , 3 , and 5 months , at their residence , in the hospital or in the ambulatory care setting .
METHODS	In between the consultations provided , the patients will have the opportunity to contact , at any moment , the case management team .
METHODS	Participants in the control group ( N = 125 ) will receive standard emergency care only .
METHODS	Data will be collected at baseline and 2 , 5.5 , 9 , and 12 months later , including : number of emergency department visits , quality of life ( EuroQOL and WHOQOL ) , health services use , and relevant costs .
METHODS	Data on feelings of discrimination and patient 's satisfaction will also be collected at the baseline and 12 months later .
CONCLUSIONS	Our study will help to clarify knowledge gaps regarding the positive outcomes ( emergency department visits , quality of life , efficiency , and cost-utility ) of an intervention based on case management care .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01934322 .

###24438121
BACKGROUND	Different diffusion of different botulinum toxin type A ( BoNTA ) preparations may account for differences in outcomes in cosmetic clinical practice .
OBJECTIVE	A double-blind , randomized , self-controlled study was performed to evaluate the diffusion characteristics of onabotulinumtoxinA and a Chinese type A botulinum toxin ( CBTX-A ) .
METHODS	Healthy volunteers ( N = 20 ) were recruited to receive a 0.05-mL ( 2U ) injection of BoTNA at four forehead sites ( medial forehead ( subcutaneous ( SC ) ) and temporal forehead ( intradermal ( ID ) ) ) .
METHODS	On day 14 , the Minor 's iodine starch test was performed and photographs were taken for calculating the area and dimensions of anhydrotic area .
RESULTS	When BoNTAs were different , the anhidrosis ID area was significantly greater with CBTX-A than onabotulinumtoxinA , the vertical dimension was significantly longer with CBTX-A ID than onabotulinumtoxinA ID and the horizontal dimension was significantly greater with CBTX-A ID than onabotulinumtoxinA ID .
RESULTS	The area of anhidrosis SC was significantly greater with CBTX-A than onabotulinumtoxinA .
RESULTS	When injection depths were different , the mean horizontal dimension was significantly greater with onabotulinumtoxinA SC than ID .
RESULTS	Comparing the dimension of the same BoNTA and injection method , the vertical dimension was significantly greater than the horizontal dimension .
CONCLUSIONS	OnabotulinumtoxinA diffuses less than CBTX-A .
CONCLUSIONS	ID injection technique may result in less diffusion than SC .

###25138109
BACKGROUND	Balance and strength training can reduce seniors ' fall risk up to 50 % .
BACKGROUND	Available evidence suggests that acute bouts of neuromuscular and endurance exercise deteriorate postural control .
BACKGROUND	High-intensity endurance training has been successfully applied in different populations .
BACKGROUND	Thus , it seemed valuable to examine the acute effects of high-intensity interval training ( HIIT ) on neuromuscular performance in seniors and young adults .
OBJECTIVE	The acute impact of a HIIT session on balance performance and muscle activity after exercise cessation and during post-exercise recovery was examined in young and old adults .
OBJECTIVE	We intended to investigate whether a transient exercise-induced fall-risk may occur in both groups .
METHODS	20 healthy seniors ( age 70 ( SD 4 ) years ) and young adults ( age 27 ( SD 3 ) years ) were examined on 3 days .
METHODS	After exhaustive ramp-like treadmill testing in order to determine maximal heart rate ( HRmax ) on the first day , either a 4 4 min HIIT at 90 % of HRmax or a control condition ( CON ) was randomly performed on the second and third day , respectively .
METHODS	Balance performance ( postural sway ) was assessed during single limb stance with open eyes ( SLEO ) and double limb stance with closed eyes ( DLEC ) .
METHODS	EMG was recorded for the soleus ( SOL ) , anterior tibialis ( TIB ) , gastrocnemius ( GM ) and peroneus longus ( PL ) muscles at the dominant leg .
METHODS	All measures were collected before , immediately as well as 10 , 30 and 45 min after HIIT and CON , respectively .
RESULTS	Compared to CON , HIIT induced significant increases of postural sway immediately after exercise cessation during SLEO in both groups ( adults : p < 0.001 , = +25 % sway ; seniors : p = 0.007 , = +15 % sway ) .
RESULTS	Increased sway during DLEC was only found for seniors immediately and 10 min after HIIT ( post : p = 0.003 , = +14 % sway , 10 min post : p = 0.004 , = +18 % sway ) .
RESULTS	Muscle activity was increased during SLEO for TIB until 10 min post in seniors ( 0.008 < p < 0.03 ) and immediately after HIIT in adults ( p < 0.001 ) .
CONCLUSIONS	HIIT training may cause an acute ` open-fall-window ' with a transient impairment of balance performance for at least 10 min after exercise cessation in both groups .
CONCLUSIONS	Occluded vision in seniors seems to prolong this period up to 30 min .
CONCLUSIONS	Thus , the advantage of HIIT with regard to time efficiency seems debatable when considering transient HIIT-induced impairments of neuromuscular function .

###24274963
BACKGROUND	Cognitive Behaviour Therapy ( CBT ) based self-help has been found to be effective for treating depression and anxiety .
BACKGROUND	There is some evidence to suggest that CBT needs to be culturally adapted for it to be effective in non-Western cultures .
BACKGROUND	CBT is not widely used in low and middle income countries and there is a need to test its effectiveness in different settings and formats , including self-help .
METHODS	We describe a RCT of a Culturally adapted CBT ( CaCBT ) based self-help manual in Pakistan .
METHODS	The trial was conducted in psychiatry departments in three cities .
METHODS	Assessments were carried out at baseline and at 12 weeks , using Hospital Anxiety and Depression Scale , Bradford somatic Inventory and brief disability Questionnaire .
RESULTS	At the end of the trial CaCBT based self-help was found to be effective against care as usual in reducing the symptoms of depression and anxiety , as well as somatic symptoms and disability .
CONCLUSIONS	This study was conducted only in secondary care and required either patient or a carer to be able to read and write .
CONCLUSIONS	This is the first study outside West of a CBT based self-help intervention for depression .
CONCLUSIONS	This study highlights the importance of using cost effective interventions in developing world in low intensity formats .
CONCLUSIONS	Future studies should focus on trying these resources in different settings , like primary care , and with the use of audio/video or multimedia resources to improve compliance in patients with lower literacy .

###24868083
OBJECTIVE	To evaluate whether provision of fixed dose combination treatment improves adherence and risk factor control compared with usual care of patients at high risk of cardiovascular disease in primary care .
METHODS	Open label randomised control trial : IMPACT ( IMProving Adherence using Combination Therapy ) .
METHODS	54 general practices in the Auckland and Waikato regions of New Zealand , July 2010 to August 2013 .
METHODS	513 adults ( including 257 indigenous Mori ) at high risk of cardiovascular disease ( established cardiovascular disease or five year risk 15 % ) who were recommended for treatment with antiplatelet , statin , and two or more blood pressure lowering drugs .
METHODS	497 ( 97 % ) completed 12 months ' follow-up .
METHODS	Participants were randomised to continued usual care or to fixed dose combination treatment ( with two versions available : aspirin 75 mg , simvastatin 40 mg , and lisinopril 10 mg with either atenolol 50 mg or hydrochlorothiazide 12.5 mg ) .
METHODS	All drugs in both treatment arms were prescribed by their usual general practitioners and dispensed by local community pharmacists .
METHODS	Primary outcomes were self reported adherence to recommended drugs ( antiplatelet , statin , and two or more blood pressure lowering agents ) and mean change in blood pressure and low density lipoprotein cholesterol at 12 months .
RESULTS	Adherence to all four recommended drugs was greater among fixed dose combination than usual care participants at 12 months ( 81 % v 46 % ; relative risk 1.75 , 95 % confidence interval 1.52 to 2.03 , P < 0.001 ; number needed to treat 2.9 , 95 % confidence interval 2.3 to 3.7 ) .
RESULTS	Adherence for each drug type at 12 months was high in both groups but especially in the fixed dose combination group : for antiplatelet treatment it was 93 % fixed dose combination v 83 % usual care ( P < 0.001 ) , for statin 94 % v 89 % ( P = 0.06 ) , for combination blood pressure lowering 89 % v 59 % ( P < 0.001 ) , and for any blood pressure lowering 96 % v 91 % ( P = 0.02 ) .
RESULTS	Self reported adherence was highly concordant with dispensing data ( dispensing of all four recommended drugs 79 % fixed dose combination v 47 % usual care , relative risk 1.67 , 95 % confidence interval 1.44 to 1.93 , P < 0.001 ) .
RESULTS	There was no statistically significant improvement in risk factor control between the fixed dose combination and usual care groups over 12 months : the difference in systolic blood pressure was -2.2 mm Hg ( -4.5 v -2.3 , 95 % confidence interval -5.6 to 1.2 , P = 0.21 ) , in diastolic blood pressure -1.2 mm Hg ( -2.1 v -0.9 , -3.2 to 0.8 , P = 0.22 ) and in low density lipoprotein cholesterol -0.05 mmol/L ( -0.20 v -0.15 , -0.17 to 0.08 , P = 0.46 ) .
RESULTS	The number of participants with cardiovascular events or serious adverse events was similar in both treatment groups ( fixed dose combination 16 v usual care 18 ( P = 0.73 ) , 99 v 93 ( P = 0.56 ) , respectively ) .
RESULTS	Fixed dose combination treatment was discontinued in 94 participants ( 37 % ) .
RESULTS	The most commonly reported reason for discontinuation was a side effect ( 54/75 , 72 % ) .
RESULTS	Overall , 89 % ( 227/256 ) of fixed dose combination participants ' general practitioners completed a post-trial survey , and the fixed dose combination strategy was rated as satisfactory or very satisfactory for starting treatment ( 206/227 , 91 % ) , blood pressure control ( 180/220 , 82 % ) , cholesterol control ( 170/218 , 78 % ) , tolerability ( 181/223 , 81 % ) , and prescribing according to local guidelines ( 185/219 , 84 % ) .
RESULTS	When participants were asked at 12 months how easy they found taking their prescribed drugs , most responded very easy or easy ( 224/246 , 91 % fixed dose combination v 212/246 , 86 % usual care , P = 0.09 ) .
RESULTS	At 12 months the change in other lipid fractions , difference in EuroQol-5D , and difference in barriers to adherence did not differ significantly between the treatment groups .
CONCLUSIONS	Among this well treated primary care population , fixed dose combination treatment improved adherence to the combination of all recommended drugs but improvements in clinical risk factors were small and did not reach statistical significance .
CONCLUSIONS	Acceptability was high for both general practitioners and patients , although the discontinuation rate was high .
BACKGROUND	Australian New Zealand Clinical Trial Registry ACTRN12606000067572 .

###24916884
BACKGROUND	We investigated the effect of resistance exercise intensity and exercise-induced metabolic stress on the activation of anabolic signaling and expression of myogenic genes in skeletal muscle .
METHODS	Ten strength-trained athletes performed high-intensity [ HI , 74 % of 1-repetition maximum ( RM ) ] , middle-intensity ( MI , 54 % 1RM ) , or middle-intensity ( 54 % 1RM ) no-relaxation exercise ( MIR ) .
METHODS	Kinase phosphorylation level and myogenic gene expression in muscle samples were evaluated before , 45 min , 5 h , and 20 h after exercise .
RESULTS	The lactate concentration in MI was approximately 2-fold lower than in the 2 other sessions , and was highest in MIR .
RESULTS	The phosphorylation level of extracellular kinase 1/2Thr202/Tyr204 after exercise was related to metabolic stress .
RESULTS	Metabolic stress induced a decrease in myostatin mRNA expression , whereas mechano-growth factor mRNA level depended on exercise intensity .
CONCLUSIONS	This study demonstrates that both intensity and exercise-induced metabolic stress can be manipulated to affect muscle anabolic signaling .

###24313686
OBJECTIVE	Acne vulgaris is common in Asian populations .
OBJECTIVE	We compared three methods of phototherapy for the treatment of moderate to severe facial acne vulgaris in Chinese patients .
METHODS	Patients were randomly assigned to receive photodynamic therapy ( PDT ) , intense pulsed light ( IPL ) or blue-red light-emitting diode ( LED ) phototherapy to the right side of the face until the inflammatory lesion count reduced by 90 % .
METHODS	Patients were examined at 1 and 3 months after the final treatment .
RESULTS	We enrolled 150 patients ( 92 males ; mean age , 28 years ) .
RESULTS	At 1 month , 90 % clearance or moderate improvement occurred in 46/50 ( 92 % ) , 29/50 ( 58 % ) and 22/50 ( 44 % ) patients in the PDT , IPL and LED groups , respectively ( mean number of sessions required , PDT : 31.52 ; IPL : 62.15 ; LED : 93.34 ) .
RESULTS	Forty-six ( 92 % ) patients experienced mild to moderate pain , erythema and edema after PDT , which resolved within 5-7 days .
RESULTS	Slight erythema and stinging were reported immediately after IPL and LED , resolving within 2h .
RESULTS	After 3 months , minimal papules and pustules were observed in 4 patients in the PDT group , 7 in the IPL group and 12 in the LED group , but no nodular pustules recurred .
CONCLUSIONS	Phototherapy is efficacious for moderate to severe facial acne vulgaris .

###24260170
OBJECTIVE	To explore the associations of green tea and rock tea consumption with risk of impaired fasting glucose ( IFG ) and impaired glucose tolerance ( IGT ) .
METHODS	A multistage , stratified , cluster , random-sampling method was used to select a representative sample from Fujian Province in China .
METHODS	In total , 4808 subjects without cardiovascular disease , hypertension , cancer , or pancreatic , liver , kidney , or gastrointestinal diseases were enrolled in the study .
METHODS	A standard questionnaire was used to gather data on tea ( green , rock , and black ) consumption and other relevant factors .
METHODS	The assessment of impaired glucose regulation ( IGR ) was using 75-g oral glucose tolerance test ( OGTT ) , the diagnostic criteria of normal glucose tolerance was according to American Diabetes Association .
RESULTS	Green tea consumption was associated with a lower risk of IFG , while rock tea consumption was associated with a lower risk of IGT .
RESULTS	The adjusted odds ratios for IFG for green tea consumption of < 1 , 1-15 , 16-30 , and > 30 cups per week were 1.0 ( reference ) , 0.42 ( 95 % confidence intervals ( CI ) 0.27-0 .65 ) , 0.23 ( 95 % CI , 0.12-0 .46 ) , and 0.41 ( 95 % CI , 0.17-0 .93 ) , respectively .
RESULTS	The adjusted odds ratios for IGT for rock tea consumption of < 1 , 1-15 , 16-30 , and > 30 cups per week were 1.0 ( reference ) , 0.69 ( 95 % CI , 0.48-0 .98 ) , 0.59 ( 95 % CI , 0.39-0 .90 ) , and 0.64 ( 95 % CI , 0.43-0 .97 ) , respectively .
RESULTS	A U-shaped association was observed , subjects who consumed 16-30 cups of green or rock tea per week having the lowest odds ratios for IFG or IGT .
CONCLUSIONS	Consumption of green or rock tea may protect against the development of type 2 diabetes mellitus in Chinese men and women , particularly in those who drink 16-30 cups per week .

###25433664
BACKGROUND	Convenient dosing , potency , and low toxicity support use of tenofovir disoproxil fumarate ( TDF ) as preferred nucleotide reverse transcriptase inhibitor ( NRTI ) for HIV-1 treatment .
BACKGROUND	However , renal and metabolic safety of TDF compared to other NRTIs has not been well described in resource-limited settings .
METHODS	This was a secondary analysis examining the occurrence of renal abnormalities ( RAs ) and renal and metabolic serious non-AIDS-defining events ( SNADEs ) through study follow-up between participants randomized to zidovudine ( ZDV ) / lamivudine / efavirenz and TDF/emtricitabine/efavirenz treatment arms within A5175/PEARLS trial .
METHODS	Exact logistic regression explored associations between baseline covariates and RAs .
METHODS	Response profile longitudinal analysis compared creatinine clearance ( CrCl ) over time between NRTI groups .
RESULTS	Twenty-one of 1,045 participants developed RAs through 192 weeks follow-up ; there were 15 out of 21 in the TDF arm ( P = .08 ) .
RESULTS	Age 41 years or older ( odds ratio [ OR ] , 3.35 ; 95 % CI , 1.1-13 .1 ) , his - tory of diabetes ( OR , 10.7 ; 95 % CI , 2.1-55 ) , and lower baseline CrCl ( OR , 3.1 per 25 mL/min decline ; 95 % CI , 1.7-5 .8 ) were associated with development of RAs .
RESULTS	Renal SNADEs occurred in 42 participants ; 33 were urinary tract infections and 4 were renal failure/insufficiency ; one event was attributed to TDF .
RESULTS	Significantly lower CrCl values were maintained among patients receiving TDF compared to ZDV ( repeated measures analysis , P = .05 ) , however worsening CrCl from baseline was not observed with TDF exposure over time .
RESULTS	Metabolic SNADEs were rare , but were higher in the ZDV arm ( 20 vs 3 ; P < .001 ) .
CONCLUSIONS	TDF is associated with lower serious metabolic toxicities but not higher risk of RAs , serious renal events , or worsening CrCl over time compared to ZDV in this randomized multinational study .

###24617232
OBJECTIVE	To observe clinical curative effect of cake-separated moxibustion on impaired glucose regulation ( IGR ) and explore its action mechanism .
METHODS	Sixty cases were randomly divided into a simple lifestyle intervention group ( control group ) and a cake-separated moxibustion combined with lifestyle intervention group ( observation group ) , 30 cases in each one .
METHODS	The control group was treated with lifestyle intervention .
METHODS	Based on lifestyle intervention , cake-separated moxibustion at Pishu ( BL 20 ) , Weishu ( BL 21 ) and Yishu ( EX-B 3 ) was applied to the observation group .
METHODS	Fast plasma glucose ( FPG ) , two hours plasma glucose after oral glucose tolerance test ( OGTT2hPG ) , fasting insulin ( FINS ) , homa insulin resistance index ( HOMA-IR ) , blood lipid , body mass index ( BMI ) and waist circumference ( WC ) were observed in the two groups before and after treatment .
RESULTS	After treatment , the OGTT2hPG and FPG were both decreased significantly ( both P < 0.05 ) in the two groups , compared between the two groups , the differences of FPG [ ( 0.41 + / - 0.42 ) mmol/L vs ( 0.05 + / - 0.08 ) mmol/L ] and OGTT2hPG [ ( 0.85 + / - 0.53 ) mmol/L vs ( 0.17 + / - 0.19 ) mmol/L ] were both statistically significant .
RESULTS	There were no significant changes in FINS , HOMA-IR , blood lipid , BMI and WC in the control group before and after treatment ( all P > 0.05 ) , but FINS , HOMA-IR levels , triglycerides ( TG ) , total cholest-erol ( TC ) , low density lipoprotein ( LDL-C ) , BMI and WC in the observation group were decreased obviously after treatment ( all P < 0.05 ) , which had statistical differences between the two groups ( all P < 0.05 ) .
CONCLUSIONS	The cake-separated moxibustion combined with lifestyle intervention can obviously control blood glucose levels , improve insulin resistance and blood lipid levels , decrease BMI and WC .

###24749664
OBJECTIVE	Previous research shows that the internet can be used in the rehabilitation of hearing-aid users .
OBJECTIVE	By further developing the online program , it might be possible to foster behavioral changes that will positively affect hearing-aid users .
METHODS	A randomized controlled study with two groups of participants .
METHODS	The intervention group underwent a five-week online intervention while the control group was referred to a waiting list .
METHODS	Questionnaires were used as outcome measures .
METHODS	Seventy-six experienced hearing-aid users participated in the study , ranging in age from 26 to 81 years ( mean 69.3 years ) .
RESULTS	The findings showed significant improvements in the intervention group after the intervention , measured by the hearing handicap inventory for the elderly .
RESULTS	The effects were maintained and improved at the follow-up .
RESULTS	Furthermore , the results indicated that the participants in the intervention group improved at two items of the international outcome inventory for hearing aids , and the effects were partly maintained at the follow-up .
RESULTS	Finally , significant improvements in the domain of psychosocial wellbeing were found at the follow-up .
CONCLUSIONS	This study provides further evidence that the internet can be used to deliver intervention of rehabilitation to hearing-aid users .

###25586724
BACKGROUND	A train-of-four ratio ( TOFR ) 0.9 measured by quantitative neuromuscular monitoring is accepted as an indication of sufficient neuromuscular recovery for extubation , even though many postsynaptic acetylcholine receptors may still be inhibited .
BACKGROUND	We investigated whether antagonism with sugammadex after spontaneous recovery to TOFR0 .9 further improves muscle function or subjective well-being .
METHODS	Following recovery to TOFR0 .9 and emergence from anaesthesia , 300 patients randomly received either sugammadex 1.0 mg kg ( -1 ) or placebo .
METHODS	Fine motor function ( Purdue Pegboard Test ) and maximal voluntary grip strength were measured before and after surgery ( before and after test drug administration ) .
METHODS	At discharge from the postanaesthesia care unit , well-being was assessed with numerical analogue scales and the Quality-of-Recovery Score 40 ( QoR-40 ) .
RESULTS	Patients ' fine motor function [ 6 ( sd 4 ) vs 15 ( 3 ) pegs ( 30 s ) ( -1 ) , P < 0.05 ] and maximal voluntary grip strength ( 284 ( 126 ) vs 386 ( 125 ) N , P < 0.05 ) were significantly lower after anaesthesia compared with the pre-anaesthesia baseline .
RESULTS	After sugammadex or placebo , motor function was significantly improved in both groups but did not reach the preoperative level .
RESULTS	There was no difference between groups at any time .
RESULTS	Global well-being was unaffected ( QoR-40 : placebo , 174 vs 185 ; sugammadex , 175 vs 186 , P > 0.05 ) .
CONCLUSIONS	Antagonizing rocuronium at TOF0 .9 with sugammadex 1.0 mg kg ( - ) ( 1 ) did not improve patients ' motor function or well-being when compared with placebo .
CONCLUSIONS	Our data support the view that TOFR0 .9 measured by electromyography signifies sufficient recovery of neuromuscular function .
BACKGROUND	The trial is registered at ClinicalTrials.gov ( NCT01101139 ) .

###24283110
OBJECTIVE	We aimed to compare the incidence of contrast-induced nephropathy ( CIN ) between atorvastatin versus rosuvastatin in patients with ST-segment elevation myocardial infarction ( STEMI ) undergoing primary coronary angioplasty .
METHODS	One hundred ninety-two consecutive patients , who underwent primary percutaneous intervention ( p-PCI ) with the diagnosis of STEMI , were included in the study .
METHODS	The patients were randomized to take atorvastatin 80 mg ( n = 98 ) or rosuvastatin 40 mg ( n = 94 ) before the procedure .
METHODS	Biochemical and complete blood count measurements were done at baseline and at 48 hours following admission .
RESULTS	The incidence of CIN was 8.9 % ( n = 17 ) in the entire groups .
RESULTS	The analysis performed between the statin groups revealed no statistical difference in any of the renal dysfunction indicators [ baseline creatinine , baseline estimated glomerular filtration rate ( eGFR ) , creatinine at 48 h , eGFR at 48 h , difference between baseline and 48 h creatinine , the per cent increase in the creatinine at 48 hours relative to basal creatinine ] .
RESULTS	In STEMI patients undergoing primary PCI , only the amount of the contrast agent administered was determined to be an independent predictor for CIN ( OR and 95 % CI : 1.08 ( 1.03 - 1.13 ) , P < or = 0.001 ) .
RESULTS	Left ventricular ejection fraction exhibited borderline statistical significance ( OR and 95 % CI : 0.88 ( 0.77-1 .01 ) , P = 0.07 ) .
CONCLUSIONS	Atorvastatin and rosuvastatin had similar efficacy in preventing CIN in patients with STEMI undergoing P-PCI .

###24623515
OBJECTIVE	The primary aim of this study was to examine the impact of physical activity ( PA ) in the natural environment ( eg , `` green exercise '' ) on resting autonomic function in the Walks4Work intervention .
OBJECTIVE	A secondary aim was to assess the feasibility of Walks4Work in terms of adherence , change in PA levels , and cardiovascular health parameters .
METHODS	In an 8-week randomized control trial , 94 office workers in an international company were allocated to one of three groups : control , nature ( NW ) , or built ( BW ) lunchtime walking route .
METHODS	Both walking groups were required to undertake two lunchtime walks each week .
METHODS	The NW route centered around trees , maintained grass , and public footpaths .
METHODS	In contrast , the BW consisted of pavement routes through housing estates and industrial areas .
METHODS	Data were collected at baseline and following the intervention .
METHODS	To investigate the impact of the intervention , mixed-design analysis of variance ( ANOVA ) were performed .
RESULTS	A total of 73 participants completed the intervention ( drop-out rate of 22 % ) .
RESULTS	No difference was observed in resting autonomic function between the groups .
RESULTS	Self-reported mental health improved for the NW group only .
RESULTS	PA levels increased at the intervention mid-point for all groups combined but adherence to the intervention was low with rates of 42 % and 43 % within the BW and NW groups , respectively .
CONCLUSIONS	Accompanying a guideline of two active lunchtimes per week with low facilitator input appears inadequate for increasing the number of active lunchtimes and modifying cardiovascular health parameters in an office population .
CONCLUSIONS	However , this population fell within normal ranges for cardiovascular measures and future research should consider investigating at-risk populations , particularly hypertensive individuals .

###25794202
BACKGROUND	Piriformis syndrome ( PS ) , which is characterized by pain radiating to the gluteal region and posterior leg , is accepted as one of the causes of sciatalgia .
BACKGROUND	Although the importance of local piriformis muscle injections whenever PS is clinically suspected has been shown in many studies , there are not enough studies considering the clinical efficacy of these injections .
OBJECTIVE	To investigate the differences between local anesthetic ( LA ) and LA + corticosteroid ( CS ) injections in the treatment of PS .
METHODS	A prospective , double-blinded , randomized controlled trial .
METHODS	Physical medicine and rehabilitation department of a university hospital .
METHODS	Fifty-seven patients having unilateral hip and/or leg pain with positive FAIR test and tenderness and/or trigger point at the piriformis muscle were evaluated .
METHODS	Out of 50 patients randomly assigned to 2 groups , 47 patients whose pain resolved at least 50 % from the baseline after the injection were diagnosed as having PS .
METHODS	The first group ( n = 22 ) received 5 mL of lidocaine 2 % while the second group ( n = 25 ) received 4 mL of lidocaine 2 % + 1 mL of betametazone under the guidance of ultrasound .
METHODS	Numeric Rating Scale ( NRS ) and Likert Analogue Scale ( LAS ) .
RESULTS	No statistically significant difference ( P > 0.05 ) was detected between the groups in NRS score values at resting ( P = 0.814 ) , night ( P = 0.830 ) , and in motion ( P = 0.145 ) , and LAS values with long duration of sitting ( P = 0.547 ) , standing ( P = 0.898 ) , and lying ( P = 0.326 ) with evaluations at baseline , first week , and first and third months after the injection .
RESULTS	A statistically highly significant ( P < 0.005 ) reduction of pain was evaluated through NRS scores at resting ( P = 0.001 ) , in motion ( P = 0.001 ) , and at night ( P = 0.001 ) and LAS values with long duration of sitting ( P = 0.001 ) , standing ( P = 0.001 ) , and lying ( P = 0.001 ) in both of the groups .
CONCLUSIONS	Presumed limitations of this study include having a relatively small sample .
CONCLUSIONS	LA injections for the PS were found to be clinically effective .
CONCLUSIONS	However , addition of CS to LA did not give an additional benefit .
CONCLUSIONS	This gives us the idea that PS is mostly muscular in origin and responds well to both LA and LA+CS injections .

###24909376
BACKGROUND	Patient information in cancer clinical trial is challenging .
BACKGROUND	The value of audio-recording interventions for patients considering participating in clinical trials is unclear .
BACKGROUND	The primary aim of this randomized study was to investigate effects of audio-recorded information on knowledge and understanding in patients considering participation in a clinical trial .
METHODS	Patients scheduled for information about a phases 2 or 3 trial by one of the 13 participating oncologists at the Department of Oncology during the study period ( 2008-2013 ) were eligible .
METHODS	The intervention consisted of an audio-recording on compact disc ( CD ) of the information at the medical consultation in which the patients were informed about a trial .
METHODS	Knowledge and understanding was measured by the questionnaire , Quality of Informed Consent .
RESULTS	A total of 130 patients were randomized , 70 % of the calculated sample size ( n = 186 ) .
RESULTS	Sixty-seven patients were randomized to the intervention .
RESULTS	In total , 101 patients ( 78 % ) completed questionnaires .
RESULTS	No statistical significant differences were found between the groups with respect to knowledge and understanding .
RESULTS	The level of knowledge was relatively high , with the exceptions of the risks associated with , and the unproven nature of , the trial .
RESULTS	Overall , patients who declined participation scored statistically significant lower on knowledge .
CONCLUSIONS	The present study was underpowered and the results should therefore be interpreted with caution .
CONCLUSIONS	Still , 130 patients were included with a response rate of 78 % .
CONCLUSIONS	A CD including the oral information about a clinical trial did not show any effects on knowledge or understanding .
CONCLUSIONS	However , the levels of knowledge were high , possible due to the high levels of education in the study group .
CONCLUSIONS	Information on risks associated with the trial is still an area for improvement .

###25132212
OBJECTIVE	To evaluate the long-term durability of the efficacy of alogliptin compared with glipizide in combination with metformin in people with type 2 diabetes inadequately controlled on stable-dose metformin .
METHODS	This multicentre , double-blind , active-controlled study randomized 2639 patients aged 18-80 years to 104 weeks of treatment with metformin in addition to alogliptin 12.5 mg once daily ( n = 880 ) , alogliptin 25 mg once daily ( n = 885 ) or glipizide 5 mg once daily , titrated to a maximum of 20 mg ( n = 874 ) .
METHODS	The primary endpoint was least square mean change from baseline in HbA1c level at 104 weeks .
RESULTS	The mean patient age was 55.4 years , the mean diabetes duration was 5.5 years and the mean baseline HbA1c was 7.6 % .
RESULTS	HbA1c reductions at week 104 were -0.68 % , -0.72 % and -0.59 % for alogliptin 12.5 and 25 mg and glipizide , respectively [ both doses met the criteria for non-inferiority to glipizide ( p < 0.001 ) ; alogliptin 25 mg met superiority criteria ( p = 0.010 ) ] .
RESULTS	Fasting plasma glucose concentration decreased by 0.05 and 0.18 mmol/l for alogliptin 12.5 and 25 mg , respectively , and increased by 0.30 mmol/l for glipizide ( p < 0.001 for both comparisons with glipizide ) .
RESULTS	Mean weight changes were -0.68 , -0.89 and 0.95 kg for alogliptin 12.5 and 25 mg and glipizide , respectively ( p < 0.001 for both comparisons with glipizide ) .
RESULTS	Hypoglycaemia occurred in 23.2 % of patients in the glipizide group vs. 2.5 and 1.4 % of patients in the alogliptin 12.5 and 25 mg groups , respectively .
RESULTS	Pancreatitis occurred in one patient in the alogliptin 25 mg group and three in the glipizide group .
CONCLUSIONS	Alogliptin efficacy was sustained over 2 years in patients with inadequate glycaemic control on metformin alone .

###25187339
OBJECTIVE	To study differences in outcomes of medication reconciliation ( MR ) when performed by clinical pharmacists compared to nurses .
METHODS	201 patients ( 21-92 years ) admitted to the Department of Cardiology at the University Hospital of North Norway , autumn 2012 , were randomized into a pharmacist group ( PG ) and a nurse group ( NG ) .
METHODS	The nurses and the pharmacists were trained for performing the MR process by an independent clinical pharmacist .
METHODS	Medication discrepancies ( MDs ) were discussed with the physicians .
METHODS	Time spent during the MR was recorded .
METHODS	An independent expert group rated clinical relevance of the MDs retrospectively .
RESULTS	At least one MD was identified in 78 % and 84 % of patients in PG and NG , respectively ( P = 0.269 ) with a mean number of MDs per patient 3.1 ( SD 2.1 ) and 2.8 ( SD 2.2 ) , respectively ( P = 0.528 ) .
RESULTS	Mean time spent/patient on the MR process was 22.9 min ( SD 11.6 ) in the PG and 32.2 min ( SD 20.3 ) in the NG ( P < 0,001 ) .
RESULTS	Physicians agreed significantly more often to act upon the MDs presented by pharmacists compared to nurses ( P = 0.001 ) .
RESULTS	The expert group finally assessed 48 % and 49 % of the MDs to be of the clinical relevance in the PG and the NG , respectively .
CONCLUSIONS	By applying a structured method for MR , a small however not statistically significant difference in identified MDs between nurses and clinical pharmacists was revealed .
CONCLUSIONS	The pharmacists spent significantly less time than the nurses , and physicians agreed significantly more often with the pharmacist that action should be taken on the MDs .
CONCLUSIONS	This is important in the discussion of who to perform MR.

###25201815
OBJECTIVE	The premotor cortex plays a major role in motor planning and control , exhibiting hierarchical importance comparable to that of the primary motor cortex ( M1 ) .
OBJECTIVE	In this study , we compared the effects of cPMd modulation , which was achieved using inhibitory repetitive transcranial magnetic stimulation ( rTMS ) , with those of contralesional M1 ( cM1 ) modulation , to elucidate the roles of both regions on longitudinal motor recovery following a stroke .
METHODS	Forty-four patients who had sustained hemiplegia for 3 to 12 months were randomly allocated to a cPMd group , cM1 group , or sham group and received 10 sessions of 1-Hz rTMS .
METHODS	The Medical Research Council ( MRC ) Scale , Fugl-Meyer Assessment ( FMA ) , Wolf Motor Function Test ( WMFT ) , and a cortical excitability test were administered pre - and post - rTMS intervention .
RESULTS	cPMd modulation yielded significant improvements in MRC , FMA , and WMFT scores compared with sham stimulation and a significant effect on cortical excitability suppression equivalent to that of cM1 modulation , but engendered effects on motor improvement inferior to those of cM1 modulation .
CONCLUSIONS	In patients with chronic stroke , the cPMd can fulfill a role similar to that of the cM1 in interhemispheric imbalance , which can be ameliorated by applying inhibitory rTMS to achieve substantial motor restoration .

###25448661
OBJECTIVE	The aim of the present clinical study was to compare early and late outcomes after inguinal hernia repair with the heavyweight mesh ( HW ) and lightweight mesh ( LW ) during a 3 year follow-up period .
METHODS	226 patients were randomized into LW and HW mesh groups , both of which underwent unilateral primary inguinal hernia repair via the Lichtenstein technique .
METHODS	Wound complications ( infection , hematoma , seroma ) , hernia recurrence , pain and feeling of foreign body in inguinal area were determined in patients .
METHODS	Pain was measured by visual analogue scale .
RESULTS	No statistical difference has been found between LW and HW groups by wound complication ( P = 0.80 ) .
RESULTS	One case of hernia recurrence has been mentioned in both groups one year after hernioplasty .
RESULTS	But there was no detectable difference between the two groups .
RESULTS	No significant difference has been found between LW and HW groups by frequency of chronic pain 7 days , 1 and 3 months , 1 , 2 , and 3 years after surgery .
RESULTS	As for the feeling of foreign body in groin it is similar in both groups after 1 and 3 months .
RESULTS	Level of feeling of foreign body was significantly lower in LW group 1 , 2 , and 3 years after surgery , than in HW group ( P = 0.03 , P = 0.02 , P = 0.02 , respectively ) .
CONCLUSIONS	Our research shows no significant difference in wound complications , hernia recurrence and chronic pain after Lichtenstein hernioplasty , by using of LW and HW meshes .
CONCLUSIONS	The usage of the LW mesh was associated with less feeling of foreign body than that of the HW mesh , what can be considered as prevalence of LW mesh hernioplasty .

###24330707
BACKGROUND	The present pharmacoeconomic study compared the direct and indirect costs of using frovatriptan versus rizatriptan in the acute treatment of migraine .
METHODS	Data on the cost-efficacy of the two triptans were derived from a recently published Italian , multicenter , randomized , double-blind , cross-over patient preference study , comparing frovatriptan versus rizatriptan .
METHODS	The direct costs were obtained by calculating the drug consumption , both of triptans and rescue medications .
METHODS	Prices of currently marketed drugs were obtained from Italian Drug Agency price list .
METHODS	The indirect costs were those related to absenteeism from the workplace due to migraine .
RESULTS	129 of the 148 patients with a current history of migraine randomized to the two study drugs and completing the study were analyzed .
RESULTS	The number of attacks treated with only 1 dose of study drug was higher with frovatriptan ( 157 vs. 147 ) , whereas the number of attacks treated with 2 doses of study medication was higher with rizatriptan ( 122 vs. 110 and 74 vs. 67 , respectively ) .
RESULTS	However , more patients treated with frovatriptan took a rescue medication ( 71 vs. 59 ) .
RESULTS	The total direct cost per attack ( including study drug rescue medication ) was 9.12 for frovatriptan and 13.54 for rizatriptan ( p < 0.05 between-treatments ) .
RESULTS	As for indirect costs , in the group of patients treated with frovatriptan the mean number of lost working hours was significantly ( p < 0.05 ) lower ( 1.5 h ) compared to the subjects who used rizatriptan ( 2.8 h ) .
RESULTS	Based on the earned income per unit of work , indirect costs per attack resulted to be 24.55 for frovatriptan and 45.84 for rizatriptan .
RESULTS	Overall , the total costs , including direct and indirect costs , were evaluated to be 33.67 for frovatriptan and 59.38 for rizatriptan , respectively .
CONCLUSIONS	Within the limitations of this model analysis , frovatriptan was found to be significantly more cost-effective than rizatriptan .
CONCLUSIONS	This outcome can be explained by the lower acquisition cost of frovatriptan , the need for fewer doses , and the loss of fewer working hours .
CONCLUSIONS	This finding could drive selection of the most appropriate oral treatment for acute migraine attacks based on both individual patient 's needs and the cost-effectiveness of the available drugs .
BACKGROUND	2006-002572-17 ( EudraCT ) .

###25419768
OBJECTIVE	To assess an intervention to limit community-associated methicillin-resistant Staphylococcus aureus ( MRSA ) dissemination .
METHODS	Randomized , controlled trial .
METHODS	County Jail , Dallas , Texas .
METHODS	A total of 4,196 detainees in 68 detention tanks .
METHODS	Tanks were randomly assigned to 1 of 3 groups : in group 1 , detainees received cloths that contained chlorhexidine gluconate ( CHG ) to clean their entire skin surface 3 times per week for 6 months ; group 2 received identical cloths containing only water ; and group 3 received no skin treatment .
METHODS	During the study , all newly arrived detainees were invited to enroll .
METHODS	Nares and hand cultures were obtained at baseline and from all current enrollees at 2 and 6 months .
RESULTS	At baseline , S. aureus was isolated from 41.2 % and MRSA from 8.0 % ( nares and/or hand ) of 947 enrollees .
RESULTS	The average participation rate was 47 % .
RESULTS	At 6 months , MRSA carriage was 10.0 % in group 3 and 8.7 % in group 1 tanks ( estimated absolute risk reduction [ 95 % confidence interval ( CI ) ] , 1.4 % [ -4.8 % to 7.1 % ] ; P = .655 ) .
RESULTS	At 6 months , carriage of any S. aureus was 51.1 % in group 3 , 40.7 % in group 1 ( absolute risk reduction [ 95 % CI ] , 10.4 % [ 0.01 % -20.1 % ] ; P = .047 ) , and 42.8 % ( absolute risk reduction [ 95 % CI ] , 8.3 % [ -1.4 % to 18.0 % ] ; P = .099 ) in group 2 .
CONCLUSIONS	Skin cleaning with CHG for 6 months in detainees , compared with no intervention , significantly decreased carriage of S. aureus , and use of water cloths produced a nonsignificant but similar decrease .
CONCLUSIONS	A nonsignificant decrease in MRSA carriage was found with CHG cloth use .
BACKGROUND	ClinicalTrials.gov identifier NCT00785200 .

###24485005
BACKGROUND	Health and social care professionals are well positioned to identify and intervene in cases of elder financial abuse .
BACKGROUND	An evidence-based educational intervention was developed to advance practitioners ' decision-making in this domain .
BACKGROUND	The objective was to test the effectiveness of a decision-training educational intervention on novices ' ability to detect elder financial abuse .
BACKGROUND	The research was funded by an E.S.R.C. grant reference RES-189-25-0334 .
METHODS	A parallel-group , randomised controlled trial was conducted using a judgement analysis approach .
METHODS	Each participant used the World Wide Web to judge case sets at pre-test and post-test .
METHODS	The intervention group was provided with training after pre-test testing , whereas the control group were purely given instructions to continue with the task .
METHODS	154 pre-registration health and social care practitioners were randomly allocated to intervention ( n78 ) or control ( n76 ) .
METHODS	The intervention comprised of written and graphical descriptions of an expert consensus standard explaining how case information should be used to identify elder financial abuse .
METHODS	Participants ' ratings of certainty of abuse occurring ( detection ) were correlated with the experts ' ratings of the same cases at both stages of testing .
RESULTS	At pre-test , no differences were found between control and intervention on rating capacity .
RESULTS	Comparison of mean scores for the control and intervention group at pre-test compared to immediate post-test , showed a statistically significant result .
RESULTS	The intervention was shown to have had a positive moderate effect ; at immediate post-test , the intervention group 's ratings had become more similar to those of the experts , whereas the control 's capacity did not improve .
RESULTS	The results of this study indicate that the decision-training intervention had a positive effect on detection ability .
CONCLUSIONS	This freely available , web-based decision-training aid is an effective evidence-based educational resource .
CONCLUSIONS	Health and social care professionals can use the resource to enhance their ability to detect elder financial abuse .
CONCLUSIONS	It has been embedded in a web resource at http://www.elderfinancialabuse.co.uk .

###25048848
BACKGROUND	Imiquimod , a synthetic Toll-like receptor 7 agonist enhanced immunogenicity of influenza vaccine in a mouse model .
BACKGROUND	We hypothesized that topical imiquimod before intradermal influenza vaccination ( TIV ) would produce similar effect in human .
METHODS	We performed a prospective 1-year follow-up , double-blind , randomized , controlled trial with adults with comorbidities .
METHODS	Participants were randomized to 1 of the following 3 vaccinations : topical 5 % 250 mg imiquimod ointment followed by intradermal TIV , topical aqueous-cream followed by intradermal TIV , or topical aqueous-cream followed by intramuscular TIV .
METHODS	Patients and investigators were blinded to the type of topical treatment applied .
METHODS	Hemagglutination inhibition ( HI ) and microneutralization antibody titers were measured .
METHODS	The primary outcome was the day 7 seroconversion rate .
RESULTS	Ninety-one recruited participants completed the study .
RESULTS	The median age was 73 years .
RESULTS	On day 7 , 27/30 ( 90 % ) patients who received imiquimod and intradermal TIV achieved seroconversion against the H1N1 strain by HI , compared with 4/30 ( 13.3 % ) who received aqueous-cream and intramuscular TIV ( P < .001 ) , and 12/31 ( 38.7 % ) who received aqueous-cream and intradermal TIV ( P < .001 ) .
RESULTS	The seroconversion , seroprotection , and geometric mean titer-fold increase were met in all 3 strains in the imiquimod and intradermal TIV group 2 weeks earlier , and the better seroconversion rate was sustained from day 7 to year 1 ( P .001 ) .
RESULTS	The better immunogenicity was associated with fewer hospitalizations for influenza or pneumonia ( P < .05 ) .
RESULTS	All adverse reactions were self-limited .
CONCLUSIONS	Pretreatment with topical imiquimod significantly expedited , augmented , and prolonged the immunogenicity of influenza vaccination .
CONCLUSIONS	This strategy for influenza immunization should be considered for the elderly population .

###24508070
BACKGROUND	Midurethral slings have become the most preferred surgical treatment for female urinary incontinence .
OBJECTIVE	To compare the efficacy and safety of two midurethral sling procedures with a different technique of sling insertion 5 yr after intervention .
METHODS	Multicenter randomized clinical trial conducted in seven public hospitals in Finland including primary cases of stress urinary incontinence .
METHODS	Surgical treatment with the retropubic tension-free vaginal tape ( TVT ) procedure or the transobturator tension-free vaginal tape ( TVT-O ) procedure .
METHODS	Objective treatment success criteria were a negative stress test , a negative 24-h pad test , and no retreatment for stress incontinence .
METHODS	Patient satisfaction was assessed by condition-specific quality-of-life questionnaires .
CONCLUSIONS	A total of 95 % of the included women could be assessed according to the protocol 5 yr after surgery .
CONCLUSIONS	The objective cure rate was 84.7 % in the TVT group and 86.2 % in the TVT-O group , with no statistical difference between the groups .
CONCLUSIONS	Subjective treatment satisfaction was 94.2 % in the TVT group and 91.7 % in the TVT-O group , with no difference between groups .
CONCLUSIONS	Complication rates were low , with no difference between groups .
CONCLUSIONS	Both objective and subjective cure rates were > 80 % in both groups even when women lost to follow-up were included as failures .
CONCLUSIONS	The complication rates were low , with no difference between the groups .
CONCLUSIONS	No late-onset adverse effects of the tape material were seen .
RESULTS	Female urinary stress incontinence can be treated surgically with minimally invasive midurethral sling procedures .
RESULTS	Two main approaches of sling placement have been developed : the retropubic and the transobturatory .
RESULTS	We compared both approaches and followed the patients for 5 yr .
RESULTS	We found no difference in cure rate between the procedures , and patient satisfaction was high .
BACKGROUND	ClinicalTrials.gov identifier NCT00379314 .

###24669604
BACKGROUND	Telmisartan and atenolol are widely used in the management of essential hypertension .
BACKGROUND	This study was conducted to compare the efficacy of these two drugs in management of patients of essential hypertension .
METHODS	Diagnosed patients of essential hypertension were selected .
METHODS	Therapeutic option ( telmisartan/atenolol ) was allocated to the patients by lottery method and they were divided into two groups .
METHODS	The patients were followed on subsequent visits ( 4 in total ) and their sitting systolic and diastolic blood pressures were recorded .
RESULTS	Total number of 180 patients were divided into two treatment groups ( i.e. , telmisaran and atenolol ) .
RESULTS	Forty percent were male and 60 % were female .
RESULTS	Majority of the patients were of age group 56-75 years .
RESULTS	Telmisartan reduced systolic and diastolic blood pressure significantly compared to atenolol at the end of 8 weeks of treatment ( p = 0.000 and 0.016 respectively ) .
CONCLUSIONS	Telmisartan 80 mg once daily is more effective than atenolol 50 mg once daily in lowering systolic and diastolic blood pressure at the end of 8 weeks of treatment .

###24760645
OBJECTIVE	To evaluate the effect of early enteral nutrition ( EEN ) on immune response and clinical outcomes after esophageal cancer operation .
METHODS	Sixty patients with esophageal cancer undergoing radical operation between March 2010 and July 2011 were randomly divided into two groups using envelope method : EEN group ( n = 30 , administration of water and enteral nutrition early after operation ) and TPN group ( n = 30 , administration of total parenteral nutrition ) .
METHODS	Two groups both received 7-day nutrition support .
METHODS	Immune indexes ( CD3 ( + ) , CD4 ( + ) , CD8 ( + ) , CD4 ( + ) / CD8 ( + ) ) and serum nutritional indexes ( albumin , pre-albumin , transferrin ) were measured before operation and 1 - , 3 - , and 7-day after operation .
METHODS	The time to first flatus , length of postoperative hospital stay , total hospitalization cost , and postoperative complication were recorded .
RESULTS	As compared to TPN group , the time to first flatus was significantly shorter in EEN group [ ( 66.57.3 ) h vs. ( 75.16.8 ) h , P < 0.01 ] , as was hospital stay [ ( 7.81.1 ) d vs. ( 9.31.3 ) d , P < 0.01 ] .
RESULTS	Total hospitalization cost [ ( 36 2103810 ) yuan vs. ( 39 7314013 ) yuan , P < 0.01 ] was lower in EEN group as compared to TPN group .
RESULTS	There was no significant difference in postoperative complication rate between the two groups [ 13.3 % ( 3/30 ) vs. 20.0 % ( 6/30 ) , P > 0.05 ] .
RESULTS	The levels of CD3 ( + ) , CD4 ( + ) , CD4 ( + ) / CD8 ( + ) , albumin , prealbumin and transferrin were significantly higher in EEN group as compared to TPN group on postoperative day 3 and 7 ( all P < 0.05 ) , while CD8 ( + ) was significantly lower in EEN group ( P < 0.05 ) .
CONCLUSIONS	EEN can promote early recovery of gastrointestinal function , improve nutritional and immune function , and therefore lead to fast postoperative recovery in esophageal cancer patients .

###25604640
BACKGROUND	Dietary intake assessment with diet records ( DR ) is a standard research and practice tool in nutrition .
BACKGROUND	Manual entry and analysis of DR is time-consuming and expensive .
BACKGROUND	New electronic tools for diet entry by clients and research participants may reduce the cost and effort of nutrient intake estimation .
OBJECTIVE	To determine the validity of electronic diet recording , we compared responses to 3-day DR kept by Tap & Track software for the Apple iPod Touch and records kept on the Nutrihand website to DR coded and analyzed by a research dietitian into a customized US Department of Agriculture ( USDA ) nutrient analysis program , entitled GRAND ( Grand Forks Research Analysis of Nutrient Data ) .
METHODS	Adult participants ( n = 19 ) enrolled in a crossover-designed clinical trial .
METHODS	During each of two washout periods , participants kept a written 3-day DR. In addition , they were randomly assigned to enter their DR in a Web-based dietary analysis program ( Nutrihand ) or a handheld electronic device ( Tap & Track ) .
METHODS	They completed an additional 3-day DR and the alternate electronic diet recording methods during the second washout .
METHODS	Entries resulted in 228 daily diet records or 12 for each of 19 participants .
METHODS	Means of nutrient intake were calculated for each method .
METHODS	Concordance of the intake estimates were determined by Bland-Altman plots .
METHODS	Coefficients of determination ( R ( 2 ) ) were calculated for each comparison to assess the strength of the linear relationship between methods .
RESULTS	No significant differences were observed between the mean nutrient values for energy , carbohydrate , protein , fat , saturated fatty acids , total fiber , or sodium between the recorded DR analyzed in GRAND and either Nutrihand or Tap & Track , or for total sugars comparing GRAND and Tap & Track .
RESULTS	Reported values for total sugars were significantly reduced ( P < .05 ) comparing Nutrihand to GRAND .
RESULTS	Coefficients of determination ( R ( 2 ) ) for Nutrihand and Tap & Track compared to DR entries into GRAND , respectively , were energy .56 , .01 ; carbohydrate .58 , .08 ; total fiber .65 , .37 ; sugar .78 , .41 ; protein .44 , .03 ; fat .36 , .03 ; saturated fatty acids .23 , .03 ; sodium .20 , .00 ; and for Nutrihand only for cholesterol .88 ; vitamin A .02 ; vitamin C .37 ; calcium .05 ; and iron .77 .
RESULTS	Bland-Altman analysis demonstrates high variability in individual responses for both electronic capture programs with higher 95 % limits of agreement for dietary intake recorded on Tap & Track .
CONCLUSIONS	In comparison to dietitian-entered 3-day DR , electronic methods resulted in no significant difference in mean nutrient estimates but exhibited larger variability , particularly the Tap & Track program .
CONCLUSIONS	However , electronic DR provided mean estimates of energy , macronutrients , and some micronutrients , which approximated those of the dietitian-analyzed DR and may be appropriate for dietary monitoring of groups .
CONCLUSIONS	Electronic diet assessment methods have the potential to reduce the cost and burden of DR analysis for nutrition research and clinical practice .
BACKGROUND	Clinicaltrials.gov NCT01183520 ; http://clinicaltrials.gov/ct2/show/NCT01183520 ( Archived by WebCite at http://www.webcitation.org/6VSdYznKX ) .

###25049340
OBJECTIVE	To test in the primary care setting the short - and long-term efficacy of a behavioral intervention that simultaneously targeted an overweight child and parent versus an information control ( IC ) targeting weight control only in the child .
METHODS	Two - to 5-year-old children who had BMI 85th percentile and an overweight parent ( BMI > 25 kg/m2 ) were randomized to Intervention or IC , both receiving diet and activity education over 12 months ( 13 sessions ) followed by 12-month follow-up ( 3 sessions ) .
METHODS	Parents in the Intervention group were also targeted for weight control and received behavioral intervention .
METHODS	Pediatricians in 4 practices enrolled their patients with the assistance of embedded recruiters ( Practice Enhancement Assistants ) who assisted with treatment too .
RESULTS	A total of 96 of the 105 children randomized ( Intervention n = 46 ; IC n = 50 ) started the program and had data at baseline .
RESULTS	Children in the Intervention experienced greater reductions in percent over BMI ( group months ; P = .002 ) and z-BMI ( group months ; P < 0.001 ) compared with IC throughout treatment and follow-up .
RESULTS	Greater BMI reduction was observed over time for parents in the Intervention compared with IC ( P < .001 ) throughout treatment and follow-up .
RESULTS	Child weight changes were correlated with parent weight changes at 12 and 24 months ( r = 0.38 and 0.26 ; P < .001 and P = .03 ) .
CONCLUSIONS	Concurrently targeting preschool-aged overweight and obese youth and their parents in primary care with behavioral intervention results in greater decreases in child percent over BMI , z-BMI , and parent BMI compared with IC .
CONCLUSIONS	The difference between Intervention and IC persists after 12 months of follow-up .

###24786931
OBJECTIVE	To evaluate the effects of intravenous ( IV ) golimumab 2 mg/kg + methotrexate ( MTX ) on patient-reported measures of health-related quality of life ( HRQOL ) in patients with active rheumatoid arthritis ( RA ) despite prior MTX therapy .
METHODS	In this randomized , multicenter , double-blind , placebo-controlled , phase III trial , adults with RA were randomly assigned to receive IV placebo ( n = 197 ) or golimumab 2 mg/kg ( n = 395 ) infusions at Week 0 , Week 4 , and every 8 weeks thereafter .
METHODS	All patients continued stable oral MTX ( 15-25 mg/wk ) .
METHODS	HRQOL assessments included Health Assessment Questionnaire-Disability Index ( HAQ-DI ; physical function ) , Medical Outcomes Study Short Form-36 questionnaire physical/mental component summary ( SF-36 PCS/MCS ) scores , EQ-5D assessment of current health state , Functional Assessment of Chronic Illness Therapy-Fatigue ( FACIT-Fatigue ) questionnaire , and disease effect on productivity [ 10-cm visual analog scale ( VAS ) ] .
RESULTS	Mean HAQ-DI improvements from baseline were significantly greater with golimumab + MTX than placebo + MTX at Week 14 and Week 24 ( p < 0.001 ) .
RESULTS	Significantly greater improvements in all 8 individual SF-36 subscores and both the SF-36 PCS and MCS scores ( p < 0.001 ) also accompanied golimumab + MTX therapy .
RESULTS	Improved EQ-5D and EQ-5D VAS ( p < 0.001 ) and FACIT-Fatigue ( p < 0.001 ) scores were also observed for golimumab + MTX-treated patients at Week 12 , Week 16 , and Week 24 , and greater proportions of golimumab + MTX-treated patients had clinically meaningful improvements in these measures .
RESULTS	Greater reductions in disease effect on productivity were observed with golimumab + MTX versus placebo + MTX at Week 24 ( p < 0.001 ) .
RESULTS	Improvements in physical function , HRQOL , fatigue , and productivity significantly correlated with disease activity improvement .
CONCLUSIONS	In active RA , IV golimumab + MTX significantly improved physical function , HRQOL , fatigue , and productivity using multiple measurement tools ; all correlated with improvements in disease activity ( NCT00973479 , EudraCT 2008-006064-11 ) .

###24610683
BACKGROUND	Previous studies have shown that heating the insulin injection site may accelerate insulin absorption .
BACKGROUND	We investigated the pharmacological profile of insulin administered with InsuPatch , a local skin-heating device .
METHODS	In this randomized , crossover study carried out in 56 subjects with type 1 diabetes treated with insulin pump [ mean age 3213.5 years ; 23 women ; HbA1c :7.80.9 % ( 6210 mmol/mol ) ( mean + / - standard deviation ) ] .
METHODS	Euglycemic glucose clamps were performed after administration of 0.15 units/kg of short-acting insulin analogues .
METHODS	Each subject underwent three clamp procedures : two with the InsuPatch device ( day 1 and day 3 ) and one without the device ( day 1 control ) .
METHODS	The primary endpoints were the following : ( 1 ) the change in the area under the curve ( AUC ) of insulin during the first 60 min post-insulin bolus on day 1 with the InsuPatch device versus day 1 control and ( 2 ) parameters to assess the safety of using the device .
RESULTS	The area under the curve of insulin during the initial 60 min ( insulin AUC ( 0-60 ) ) after insulin bolus was increased by 29.77 % on day 1 InsuPatch versus day 1 control ( p < 0.01 ) .
RESULTS	Maximal post-insulin bolus concentration was 57 mU/L on day 1 InsuPatch versus 47.6 mU/L on day 1 control ( p < 0.01 ) .
RESULTS	On day 3 InsuPatch , insulin AUC ( 0-60 ) was increased by 27.972 % versus day 1 InsuPatch ( p < 0.01 ) .
RESULTS	Maximal insulin concentration was 70.4 mU/L versus 57 mU/L , respectively ( p = 0.05 ) .
CONCLUSIONS	The use of the heating device upon administration of short-acting insulin analogues in pump-treated type 1 diabetic patients was found to enhance insulin absorption .
CONCLUSIONS	This heating device may therefore serve to achieve better meal insulin coverage .

###25511331
BACKGROUND	Diagnosis of different parkinsonian syndromes is linked with high misdiagnosis rates and various confounding factors .
BACKGROUND	This is particularly problematic in its early stages .
BACKGROUND	With this in mind , the current pilot study aimed to distinguish between Idiopathic Parkinson 's Disease ( iPD ) , other Parkinsonian syndromes ( non-iPD ) and healthy subjects , by a breath test that analyzes the exhaled volatile organic compounds using a highly sensitive nanoarray .
METHODS	Breath samples of 44 iPD , 16 non-iPD patients and 37 healthy controls were collected .
METHODS	The samples were passed over a nanoarray and the resulting electrical signals were analyzed with discriminant factor analysis as well as by a K-fold cross-validation method , to test the accuracy of the model .
RESULTS	Comparison of non-iPD with iPD states yielded 88 % sensitivity , 88 % accuracy , and 88 % Receiver Operating Characteristic area under the curve in the training set samples with known identity .
RESULTS	The validation set of this comparison scored 81 % sensitivity and accuracy and 92 % negative predictive value .
RESULTS	Comparison between atypical parkinsonism states and healthy subjects scored 94 % sensitivity and 85 % accuracy in the training set samples with known identity .
RESULTS	The validation set of this comparison scored 81 % sensitivity and 78 % accuracy .
RESULTS	The obtained results were not affected by l-Dopa or MAO-B inhibitor treatment .
CONCLUSIONS	Exhaled breath analysis with nanoarray is a promising approach for a non-invasive , inexpensive , and portable technique for differentiation between different Parkinsonian states .
CONCLUSIONS	A larger cohort is required in order to establish the clinical usefulness of the method .

###25467617
OBJECTIVE	To compare treatment with metformin alone , metformin plus insulin and insulin alone in women with gestational diabetes ( GDM ) .
METHODS	A total of 150 gestational diabetic patients who fulfilled the eligibility criteria were included in this prospective randomized control open labeled study .
METHODS	A risk factor based screening was done followed by a GCT and then local GTT criteria from antenatal clinics .
METHODS	They were initially divided into two groups with odd numbers assigned to metformin treatment and even numbers to insulin treatment .
METHODS	Metformin and/or insulin treatment was given and target blood sugar levels aimed at FBS 100 mg/dl and postprandial levels 126 mg/dl .
METHODS	Supplemental insulin was added to metformin treatment group to maintain the glycemic targets if required .
METHODS	Patients were followed until delivery and maternal fetal outcomes and pharmacotherapeutic characteristics were recorded on a performa .
RESULTS	Less maternal weight gain was found in the metformin treated groups ( 9.8 1.5 kg [ metformin alone ] vs. 9.8 1.4 kg [ metformin plus insulin ] vs. 12.5 1.1 kg [ insulin alone ] P < 0.000 ) .
RESULTS	Preeclampsia was significantly less in metformin treated groups .
RESULTS	There were no perinatal deaths in the study .
RESULTS	Mean birth weight was significantly less in metformin treated groups ( 3.4 0.4 kg vs. 3.3 0.5 kg vs. 3.7 0.5 kg P < 0.01 ) .
RESULTS	Less neonatal morbidity was observed in metformin groups .
RESULTS	42.7 % of patients required supplemental insulin ( mean dose of 13.6 2 units ) in the metformin group .
RESULTS	Mean gestational age at which insulin was added was 31.8 5.9 weeks .
CONCLUSIONS	Metformin is an effective and cheap treatment option for women with gestational diabetes with or without supplemental insulin .

###26120988
OBJECTIVE	To study the effect of vasonit on the structural/functional state of erythrocyte cytoplasmic membrane in patients with ischemic stroke ( 11 ) using atomic-power microscopy in vitro .
METHODS	We examined 45 patients with II .
METHODS	Patients of the main group ( n = 30 ) received vasonit and standard treatment , 15 patients of the comparison group received only standard treatment .
METHODS	To assess the severity of patient 's condition , we used the NIH stroke scale , modified Rankin scale , the Barthel index and the Rivermead Mobility index .
METHODS	Dried erythrocyte preparations were made to study erythrocyte cytoplasmic membrane .
METHODS	Scanning was performed using an atomic-power microscope manufactured by `` SOLVER P47-Pro '' ( NT-MDT , Russia ) .
CONCLUSIONS	A statistically significant positive dynamics of neurological deficit and patient 's functional state was found in the 14 '' day of the study .
CONCLUSIONS	A significant decrease in Young 's modulus value was identified in the main group that suggested the increase in the elasticity of erythrocyte cytoplasmic membrane .

###24423336
BACKGROUND	Metformin is used to reduce pregnancy complications in women with polycystic ovary syndrome ( PCOS ) , although it is not approved for this indication and solid evidence is lacking .
BACKGROUND	Midpregnancy Doppler ultrasound is one of the best methods for prediction of adverse pregnancy outcome .
OBJECTIVE	The objectives of the study were to investigate the following : 1 ) whether metformin treatment influenced the midpregnancy pulsatility index ( PI ) of the uterine artery ; 2 ) whether metabolic or endocrine factors affect the PI of the uterine artery of PCOS women ; and 3 ) whether PI predicted adverse pregnancy outcome in PCOS woman .
METHODS	This is a substudy of a randomized , placebo-controlled , double-blind , multicenter study conducted at 11 secondary care centers .
METHODS	We randomly assigned 273 pregnancies to receive metformin or placebo , from the first trimester of pregnancy to delivery .
METHODS	In the present substudy , 231 pregnancies are included , ie , those who completed the ultrasound examinations .
METHODS	Midpregnancy PI in the uterine artery related to metformin use , androgen levels , an oral glucose tolerance test , and insulin levels was measured .
METHODS	We found no difference in the PI between the metformin and placebo groups .
METHODS	In multivariate analyses , fasting serum glucose of the first and second trimester correlated positively to the midpregnancy PI .
METHODS	Only in univariate analyses a weak correlation between androstenedione and PI was seen .
CONCLUSIONS	Metformin treatment did not affect uterine artery blood flow , measured by PI .
CONCLUSIONS	High fasting blood glucose correlated inversely to uterine artery blood flow .
CONCLUSIONS	The midpregnancy PI correlated positively to preeclampsia , hypertension , and gestational diabetes mellitus in PCOS pregnancies .
CONCLUSIONS	Androgen levels correlated only to PI in univariate analyses .

###25876525
BACKGROUND	Erlotinib is a highly active epidermal growth factor receptor ( EGFR ) kinase inhibitor that is approved for first-line use in lung cancers harboring EGFR mutations .
BACKGROUND	Anecdotal experience suggests that this drug may provide continued disease control after patients develop objective progression of disease ( PD ) , although this has not been systematically studied to date .
METHODS	Patients who had Response Evaluation Criteria In Solid Tumors-defined PD who were participating in 3 prospective trials of first-line erlotinib in advanced lung cancer were studied retrospectively , and the progression characteristics were compared between patients with and without EGFR-sensitizing mutations .
METHODS	Factors were studied that influenced the time until treatment change ( TTC ) , defined as the time from PD to the start of a new systemic therapy or death .
METHODS	The rate of tumor progression was assessed by comparing tumor measurements between the computed tomography scan obtained at the time of PD and the preceding scan .
RESULTS	In total , 92 eligible patients were studied , including 42 with and 50 without an EGFR-sensitizing mutation .
RESULTS	The EGFR-mutant cohort had a slower rate of progression ( P = .003 ) and a longer TTC ( P < .001 ) .
RESULTS	Among the patients with EGFR-mutant cancers , 28 ( 66 % ) continued single-agent erlotinib after PD , and 21 ( 50 % ) were able to delay a change in systemic therapy for > 3 months ; only 2 patients received local debulking therapy during that period .
RESULTS	Multivariate analysis of the patients with EGFR-mutant tumors demonstrated that a longer time to progression , a slower rate of progression , and a lack of new extrathoracic metastases were associated with a longer TTC .
CONCLUSIONS	A change in systemic therapy commonly can be delayed in patients with EGFR-mutant lung cancer who objectively progress on first-line erlotinib , particularly in those with a longer time to progression , a slow rate of progression , and a lack of new extrathoracic metastases .

###24793658
OBJECTIVE	The effectiveness of noninvasive positive pressure ventilation delivered by helmet ( H-NPPV ) as a weaning approach in patients with acute respiratory failure is unclear .
METHODS	We randomly and evenly assigned 64 patients intubated for acute respiratory failure to conventional weaning with invasive mechanical ventilation ( IMV ) or H-NPPV .
METHODS	The primary end point was a reduction in IMV duration by 6 days between the 2 groups .
METHODS	Secondary end points were the occurrence of ventilator-associated pneumonia and major complications , duration of mechanical ventilation and weaning , intensive care unit and hospital length of stay , and survival .
RESULTS	The mean duration of IMV was significantly reduced in the H-NPPV group compared with the IMV group ( P < .0001 ) , without significant difference in duration of weaning ( P = .26 ) and total ventilatory support ( P = .45 ) .
RESULTS	In the H-NPPV group , the incidence of major complications was less than the IMV group ( P = .032 ) .
RESULTS	Compared with the H-NPPV group , the IMV group was associated with a greater incidence of VAP ( P = .018 ) and an increased risk of nosocomial pneumonia ( P = .049 ) .
RESULTS	The mortality rate was similar between the groups , with no significant difference in overall intensive care unit ( P = .47 ) or hospital length of stay ( P = .37 ) .
CONCLUSIONS	H-NPPV was well tolerated and effective in patients who were difficult to wean .

###24754044
BACKGROUND	In laboratory studies , exercise immediately before sexual stimuli improved sexual arousal of women taking antidepressants [ 1 ] .
BACKGROUND	We evaluated if exercise improves sexual desire , orgasm , and global sexual functioning in women experiencing antidepressant-induced sexual side effects .
METHODS	Fifty-two women who were reporting antidepressant sexual side effects were followed for 3 weeks of sexual activity only .
METHODS	They were randomized to complete either three weeks of exercise immediately before sexual activity ( 3/week ) or 3 weeks of exercise separate from sexual activity ( 3/week ) .
METHODS	At the end of the first exercise arm , participants crossed to the other .
METHODS	We measured sexual functioning , sexual satisfaction , depression , and physical health .
RESULTS	Exercise immediately prior to sexual activity significantly improved sexual desire and , for women with sexual dysfunction at baseline , global sexual function .
RESULTS	Scheduling regular sexual activity significantly improved orgasm function ; exercise did not increase this benefit .
RESULTS	Neither regular sexual activity nor exercise significantly changed sexual satisfaction .
CONCLUSIONS	Scheduling regular sexual activity and exercise may be an effective tool for the behavioral management of sexual side effects of antidepressants

###25315325
BACKGROUND	Overweight and obesity during pregnancy represents a considerable health burden .
BACKGROUND	While research has focused on interventions to limit gestational weight gain , there is little information describing their impact on neonatal health .
BACKGROUND	Our aim was to investigate the effect on a range of pre-specified secondary neonatal outcomes of providing antenatal dietary and lifestyle advice to women who are overweight or obese .
METHODS	We report a range of pre-specified secondary neonatal outcomes from a large randomised trial in which antenatal dietary and lifestyle advice was provided to women who were overweight or obese .
METHODS	Pregnant women were eligible for participation with a body mass index of 25 kg/m ( 2 ) or over , and singleton gestation between 10 ( +0 ) and 20 ( +0 ) weeks .
METHODS	Outcome measures included gestational age at birth ; Apgar score below 7 at 5 minutes of age ; need for resuscitation at birth ; birth weight above 4.5 kg or below 2.5 kg ; birth weight , length and head circumference ( and Z-scores ) ; admission to the nursery ; respiratory distress syndrome ; and postnatal length of stay .
METHODS	Data relating to the primary outcome ( large for gestational age infants defined as birth weight above the 90th centile ) and birth weight above 4 kg have been reported previously .
METHODS	Analyses used intention-to-treat principles .
RESULTS	In total , 2,142 infants were included in the analyses .
RESULTS	Infants born to women following lifestyle advice were significantly less likely to have birth weight above 4.5 kg ( 2.15 % versus 3.69 % ; adjusted risk ratio ( aRR ) = 0.59 ; 95 % confidence interval ( CI ) 0.36 to 0.98 ; P = 0.04 ) , or respiratory distress syndrome ( 1.22 % versus 2.57 % ; aRR = 0.47 ; 95 % CI 0.24 to 0.90 ; P = 0.02 ) , particularly moderate or severe disease , and had a shorter length of postnatal hospital stay ( 3.947.26 days versus 4.419.87 days ; adjusted ratio of means 0.89 ; 95 % CI 0.82 to 0.97 ; P = 0.006 ) compared with infants born to women who received Standard Care .
CONCLUSIONS	For women who are overweight or obese , antenatal dietary and lifestyle advice has health benefits for infants , without an increase in the risk of harm .
CONCLUSIONS	Continued follow-up into childhood will be important to assess the longer-term effects of a reduction in high infant birth weight on risk of child obesity .
CONCLUSIONS	Please see related articles : http://www.biomedcentral.com/1741-7015/12/161 and http://www.biomedcentral.com/1741-7015/12/201 .
BACKGROUND	Australian and New Zealand Clinical Trials Registry ( ACTRN12607000161426 ) .

###24265104
BACKGROUND	Preclinical and clinical studies indicate that the administration of glucocorticoids may promote fear extinction processes .
BACKGROUND	In particular , it has been shown that glucocorticoids enhance virtual reality based exposure therapy of fear of heights .
BACKGROUND	Here , we investigate whether glucocorticoids enhance the outcome of in vivo exposure-based group therapy of spider phobia .
METHODS	In a double blind , block-randomized , placebo-controlled , between-subject study design , 22 patients with specific phobia of spiders were treated with two sessions of in vivo exposure-based group therapy .
METHODS	Cortisol ( 20 mg ) or placebo was orally administered 1 hr before each therapy session .
METHODS	Patients returned for a follow-up assessment one month after therapy .
RESULTS	Exposure-based group therapy led to a significant decrease in phobic symptoms as assessed with the Fear of Spiders Questionnaire ( FSQ ) from pretreatment to immediate posttreatment and to follow-up .
RESULTS	The administration of cortisol to exposure therapy resulted in increased salivary cortisol concentrations and a significantly greater reduction in fear of spiders ( FSQ ) as compared to placebo at follow-up , but not immediately posttreatment .
RESULTS	Furthermore , cortisol-treated patients reported significantly less anxiety during standardized exposure to living spiders at follow-up than placebo-treated subjects .
RESULTS	Notably , groups did not differ in phobia-unrelated state-anxiety before and after the exposure sessions and at follow-up .
CONCLUSIONS	These findings indicate that adding cortisol to in vivo exposure-based group therapy of spider phobia enhances treatment outcome .

###24742116
OBJECTIVE	To investigate whether interventions that have positive effects on psychological symptoms and quality of life compared with usual care would also reduce days on sick leave .
METHODS	A randomized controlled trial .
METHODS	A large primary health care centre in Stockholm , Sweden .
METHODS	Intervention .
METHODS	Patients with common mental disorders were recruited by their GPs and randomized into one of two group interventions that took place in addition to usual care .
METHODS	These group interventions were : ( a ) group cognitive behavioural therapy ( CBT ) , and ( b ) group multimodal intervention ( MMI ) .
METHODS	Both types of intervention had previously shown significant effects on quality of life , and MMI had also shown significant effects on psychological symptoms .
METHODS	Of the 245 randomized patients , 164 were employed and had taken sick leave periods of at least two weeks in length during the study period of two years .
METHODS	They comprised the study group .
METHODS	The odds , compared with usual care , for being sick-listed at different times relative to the date of randomization .
RESULTS	The mean number of days on sick leave increased steadily in the two years before randomization and decreased in the two years afterwards , showing the same pattern for all three groups .
RESULTS	The CBT and MMI interventions did not show the expected lower odds for sick-listing compared with usual care during the two-year follow-up .
CONCLUSIONS	Reduction in psychological symptoms and increased well-being did not seem to be enough to reduce sickness absence for patients with common mental problems in primary care .
CONCLUSIONS	The possibility of adding workplace-oriented interventions is discussed .

###25498776
BACKGROUND	Medical nonpersistence is a worldwide problem of striking magnitude .
BACKGROUND	Although many fields of studies including epidemiology , sociology , and psychology try to identify determinants for medical nonpersistence , comprehensive research to explain medical nonpersistence from an economics perspective is rather scarce .
OBJECTIVE	The aim of the study was to develop a conceptual framework that augments standard economic choice theory with psychological concepts of behavioral economics to understand how patients ' preferences for discontinuing with therapy arise over the course of the medical treatment .
OBJECTIVE	The availability of such a framework allows the targeted design of mechanisms for intervention strategies .
METHODS	Our conceptual framework models the patient as an active economic agent who evaluates the benefits and costs for continuing with therapy .
METHODS	We argue that a combination of loss aversion and mental accounting operations explains why patients discontinue with therapy at a specific point in time .
METHODS	We designed a randomized laboratory economic experiment with a student subject pool to investigate the behavioral predictions .
RESULTS	Subjects continue with therapy as long as experienced utility losses have to be compensated .
RESULTS	As soon as previous losses are evened out , subjects perceive the marginal benefit of persistence lower than in the beginning of the treatment .
RESULTS	Consequently , subjects start to discontinue with therapy .
CONCLUSIONS	Our results highlight that concepts of behavioral economics capture the dynamic structure of medical nonpersistence better than does standard economic choice theory .
CONCLUSIONS	We recommend that behavioral economics should be a mandatory part of the development of possible intervention strategies aimed at improving patients ' compliance and persistence behavior .

###25141110
OBJECTIVE	The aim of this placebo-controlled study was to evaluate the effects of pulsed and continuous ultrasound treatments combined with splint therapy on patients with mild and moderate idiopathic carpal tunnel syndrome .
METHODS	The study included 46 carpal tunnel syndrome patients who were randomly divided into 3 groups .
METHODS	The first group ( n = 15 ) received a 0 W/cm2 ultrasound treatment ( placebo ) ; the second group ( n = 16 ) received a 1.0 W/cm2 continuous ultrasound treatment and the third group ( n = 15 ) received a 1.0 W/cm2 1:4 pulsed ultrasound treatment 5 days a week for a total of 15 sessions .
METHODS	All patients also wore night splints during treatment period .
METHODS	Pre-treatment and post-treatment Visual Analogue Scale , Symptom Severity Scale and Functional Status Scale scores , median nerve motor conduction velocity and distal latency and sensory conduction velocities of the median nerve in the 2nd finger and palm were compared .
METHODS	Clinicaltrials.gov : NCT02054247 .
RESULTS	There were significant improvements in all groups in terms of the post-treatment Functional Status Scale score ( p < 0.05 for all groups ) , Symptom Severity Scale score ( first group : p < 0.05 , second group : p < 0.01 , third group : p < 0.001 ) and Visual Analogue Scale score ( first and third groups : p < 0.01 , second group : p < 0.001 ) .
RESULTS	Sensory conduction velocities improved in the second and third groups ( p < 0.01 ) .
RESULTS	Distal latency in the 2nd finger showed improvement only in the third group ( p < 0.01 ) and action potential latency in the palm improved only in the second group ( p < 0.05 ) .
CONCLUSIONS	The results of this study suggest that splinting therapy combined with placebo and pulsed or continuous ultrasound have similar effects on clinical improvement .
CONCLUSIONS	Patients treated with continuous and pulsed ultrasound showed electrophysiological improvement ; however , the results were not superior to those of the placebo .

###25624439
OBJECTIVE	Information about symptomatic toxicities of anticancer treatments is not based on direct report by patients , but rather on reports by clinicians in trials .
OBJECTIVE	Given the potential for under-reporting , our aim was to compare reporting by patients and physicians of six toxicities ( anorexia , nausea , vomiting , constipation , diarrhea , and hair loss ) within three randomized trials .
METHODS	In one trial , elderly patients with breast cancer received adjuvant chemotherapy ; in two trials , patients with advanced non-small-cell lung cancer received first-line treatment .
METHODS	Toxicity was prospectively collected by investigators ( graded by National Cancer Institute Common Toxicity Criteria [ version 2.0 ] or Common Terminology Criteria for Adverse Events [ version 3 ] ) .
METHODS	At the end of each cycle , patients completed the European Organisation for Research and Treatment of Cancer quality-of-life questionnaires , including toxicity-related symptom items .
METHODS	Possible answers were `` not at all , '' `` a little , '' `` quite a bit , '' and `` very much . ''
METHODS	Analysis was limited to the first three cycles .
METHODS	For each toxicity , agreement between patients and physicians and under-reporting by physicians ( ie , toxicity reported by patients but not reported by physicians ) were calculated .
RESULTS	Overall , 1,090 patients ( 2,482 cycles ) were included .
RESULTS	Agreement between patients and physicians was low for all toxicities .
RESULTS	Toxicity rates reported by physicians were always lower than those reported by patients .
RESULTS	For patients who reported toxicity ( any severity ) , under-reporting by physicians ranged from 40.7 % to 74.4 % .
RESULTS	Examining only patients who reported `` very much '' toxicity , under-reporting by physicians ranged from 13.0 % to 50.0 % .
CONCLUSIONS	Subjective toxicities are at high risk of under-reporting by physicians , even when prospectively collected within randomized trials .
CONCLUSIONS	This strongly supports the incorporation of patient-reported outcomes into toxicity reporting in clinical trials .

###25248418
BACKGROUND	A randomized controlled trial showed that patients with grade III or IV internal hemorrhoids had similar symptomatic relief of symptoms up to 3 months following dearterialization with mucopexy or hemorrhoidectomy albeit with less postoperative pain after the former .
BACKGROUND	This study aimed to compare hemorrhoidal recurrence and chronic complications at 3-year follow-up .
METHODS	This study was carried out on 40 patients with grade III or IV internal hemorrhoids previously enrolled to a randomized trial comparing dearterialization to hemorrhoidectomy .
METHODS	Recurrence was defined as internal hemorrhoids diagnosed on proctoscopy .
METHODS	Chronic complications were nonresolving adverse events related to surgery .
METHODS	Outcome measures included patient-reported outcomes and quality of life measured by brief pain inventory ( BPI ) , SF-12 , and fecal incontinence surveys .
RESULTS	At median follow-up of 36 ( 27-43 ) months , 13 patients ( 32.5 % ) were lost to follow-up .
RESULTS	Patient-reported outcomes suggested no difference between dearterialization and hemorrhoidectomy in persistent symptoms , occurring in 1 ( 8.3 % ) vs. 2 ( 13.3 % ) patients ( p = 0.681 ) and in symptom recurrence , occurring in 6 ( 50 % ) vs. 4 ( 26.7 % ) patients ( p = 0.212 ) .
RESULTS	On proctoscopy , recurrence was seen in 2 ( 13.3 % ) vs. 1 ( 6.7 % ) patients ( p = 0.411 ) , all with index grade IV disease .
RESULTS	One patient in each arm required reoperation ( p = 0.869 ) .
RESULTS	Chronic complications were not seen in the dearterialization arm while they occurred in 2 ( 13.3 % ) hemorrhoidectomy patients ( p = 0.189 ) and included unhealed wound ( n = 1 ) , anal fissure ( n = 1 ) and fecal incontinence ( n = 1 ) .
RESULTS	There was a trend toward more patient reported than actual recurrence on proctoscopy ( 10 vs. 3 , p = 0.259 ) .
RESULTS	There was no difference in BPI , SF-12 , and fecal incontinence quality of life scores .
CONCLUSIONS	Recurrence rates did not differ significantly at 3-year follow-up and occurred in patients with index grade IV hemorrhoids .
CONCLUSIONS	Chronic complications occurred only after hemorrhoidectomy .

###24525810
BACKGROUND	Premature discontinuation of antidepressant drugs is a frequent clinical problem .
BACKGROUND	Adverse effects are common , occur early on in treatment and are reported to be one of the main reasons for discontinuation of antidepressant treatment .
OBJECTIVE	To investigate the association between adverse effects occurring in the first 2weeks of antidepressant treatment and discontinuation by 6weeks as the outcome .
OBJECTIVE	To investigate the time profile of adverse effects induced by the selective serotonin reuptake inhibitor citalopram and the noradrenaline reuptake inhibitor reboxetine over 12weeks of treatment .
METHODS	Six hundred andone depressed individuals were randomly allocated to either citalopram ( 20mg daily ) or reboxetine ( 4mg twice daily ) .
METHODS	A modified version of the Toronto Side Effects Scale was used to measure 14 physical symptoms at baseline ( medication free ) and at 2 , 6 and 12weeks after randomisation .
RESULTS	Individuals randomised to reboxetine reported a greater number of adverse effects and were more likely to stop treatment than individuals receiving citalopram .
RESULTS	Dizziness ( OR 1.83 ; 95 % CI 1.09 , 3.09 ; p = 0.02 ) and the total number of adverse effects ( OR 1.12 ; 95 % CI 1.00 , 1.25 ; p = 0.06 ) reported at 2weeks were associated with discontinuation from overall antidepressant treatment by 6weeks .
RESULTS	Reports of adverse effects tended to reduce throughout the 12weeks for both antidepressants .
CONCLUSIONS	The majority of adverse effects were not individually associated with discontinuation from antidepressant treatment .
CONCLUSIONS	Reports of physical symptoms tended to reduce over time .
CONCLUSIONS	The physical symptoms that did not reduce over time may represent symptoms of depression rather than antidepressant-induced adverse effects .

###25604111
OBJECTIVE	To compare the effect of slight and usual sedation on the prognosis and inflammatory marker levels in patients receiving mechanical ventilation in ICU .
METHODS	We enrolled 78 critically ill adult patients who were undergoing mechanical ventilation and were expected to need ventilation for more than 48 h.
METHODS	The patients were prospectively and randomly assigned to receive : slight sedation ( Richmond Agitation Sedation Score -1 to 0 , n = 38 patients ) or usual sedation ( Richmond Agitation Sedation Score -3 to -2 , n = 40 patients ) .
METHODS	Sedative dosages , duration of mechanical ventilation , length of ICU stay , complications ( ventilator-associated pneumonia , tracheotomy ) , adverse reactions ( accidental extubation , reintubation , barotrauma ) and levels of inflammatory markers on the day of sedation time for 48 h were recorded .
RESULTS	When compared with the usual sedation group , duration of mechanical ventilation ( d ) ( 8 5 vs 13 8 , P < 0.05 ) and length of ICU stay ( d ) ( 12 10 vs 22 9 , P < 0.05 ) were significantly shorter in the slight sedation group .
RESULTS	The total doses of midazolam ( mg ) , propofol ( mg ) and fentany ( g ) were lower in the slight sedation group than those in the usual sedation group ( 275 85 vs 575 142 , 4 562 1 128 vs 7 434 1 712 and 2 332 1 458 vs 4 124 2 743 , P < 0.05 ) .
RESULTS	Accidental extubation ( 5 % vs 3 % ) , reintubation ( 5 % vs 10 % ) and barotraumas ( 3 % vs 8 % ) showed no differences between the 2 groups ( P > 0.05 ) .
RESULTS	In the slight sedation group , the incidences of ventilator-associated pneumonia ( 26 % vs 53 % ) and tracheotomy ( 18 % vs 48 % ) were significantly decreased compared with those in the usual group .
RESULTS	The levels of IL-1 ( 35 12 vs 47 18 , P < 0.05 ) ng/L , IL-6 ( 49 21 vs 62 27 , P < 0.05 ) ng/L , TNF - ( 39 16 vs 52 25 , P < 0.05 ) ng/L and CRP ( 95 41 vs 125 45 , P < 0.05 ) mg/L were also lower in the slight sedation group than those in the conventional group .
RESULTS	There were no differences in ICU mortality and 28 d-survival rate between the 2 groups .
CONCLUSIONS	Slight sedation was shown to reduce the length of mechanical ventilation and ICU stay .
CONCLUSIONS	It also decreased the levels of inflammatory markers while did n't increase the incidence of adverse reactions .

###26009832
BACKGROUND	Combination antiretroviral therapy ( ART ) for HIV-1-infected individuals prevents sexual transmission if viral load is suppressed .
METHODS	Participants were HIV-1-infected partners randomized to early ART ( CD4 350-550 ) in HPTN052 ( n = 886 , median follow-up = 2.1 years ) , a clinical trial of early ART to prevent sexual transmission of HIV-1 in serodiscordant couples at 13 sites in 9 countries .
METHODS	Adherence was assessed through pill count ( dichotomized at < 95 % ) and through self-report items .
METHODS	Predictors of adherence were mental health and general health perceptions , substance use , binge drinking , social support , sexual behaviors , and demographics .
METHODS	Viral suppression was defined as HIV plasma viral load < 400 copies per milliliter .
METHODS	Adherence counseling and couples ' counseling about safer sex were provided .
METHODS	Logistic and linear regression models using generalized estimating equation for repeated measurements were used .
RESULTS	Through pill count , 82 % of participants were adherent at 1 month and 83.3 % at 1 year .
RESULTS	Mental health was the only psychosocial variable associated with adherence [ pill count , odds ratios ( OR ) = 1.05 , 95 % confidence intervals ( CIs ) : 1.00 to 1.11 ; self-report parameter estimate , OR = 0.02 , 95 % CI : 0.01 to 0.04 ] , although regional differences emerged .
RESULTS	Pill count ( OR = 1.19 , 95 % CI : 1.10 to 1.30 ) and self-report ( OR = 1.42 , 95 % CI : 1.14 to 1.77 ) adherence were associated with viral suppression .
CONCLUSIONS	Although adherence was high among individuals in stable relationships taking ART for prevention , mental health and adherence covaried .
CONCLUSIONS	Assessing and intervening on mental health in the context of promoting adherence to ART as prevention should be explored .
CONCLUSIONS	Adherence and couples ' counseling , feedback about viral suppression , and/or altruism may also help explain the magnitude of adherence observed .

###26521571
OBJECTIVE	To compare the difference of clinical efficacy on sleeping disorder in the children with encephalopathy between the combined therapy of acupuncture at head points and seed-pressure at ear points and the simple acupuncture at head points .
METHODS	Thirty cases of sleeping disorder induced by encephalopathy werei randomized into an observation group and a control group , 15 cases in each one .
METHODS	In the observation group , the combined therapy of acupuncture at head points and seed-pressure at ear points was adopted .
METHODS	The head points in cluded Sishencong ( EX-HN 1 ) , Shenting ( GV 24 ) and Benshen ( GB 13 ) .
METHODS	The ear points were the positive reactive sites in the cymba and cavum conchae .
METHODS	In the control group , acupuncture was applied simply to the acupoints on the head .
METHODS	The treatment was given once on every Tuesday and Friday a week separately , 30 min each time .
METHODS	Totally , 16 treatments were required .
METHODS	Children 's sleeping habit questionnaire ( CSHQ ) was used to observe the sleep improvements and the efficacy in the patients of the two groups .
RESULTS	In the observation group , the results of sleep resistance , sleep anxiety , night sleep wake , parasomnias , sleep dyspnea , daytime somnolence and the total score after treatment were all improved apparently as compared with those before treatment ( all P < 0.05 ) .
RESULTS	In the control group , the results of night sleep wake , parasomnias , daytime somnolence and the total score after treatment were improved apparently than those before treatment ( all P < 0.05 ) .
RESULTS	In the observation group , the results of sleep resistance , sleep dyspnea and the total score after treatment were better than those in the control group ( all P < 0.05 ) and the scores of sleep anxiety and daytime somnolence in the control group were better than those in the observation group after treatment ( both P < 0.05 ) .
CONCLUSIONS	The combined therapy of acupuncture at head points and seed-pressure at the positive reactive sites in the cymba and cavum conchae achieves the superior efficacy on sleep resistance and sleep dyspnea as compared with the simple acupuncture .
CONCLUSIONS	The efficacy of simple acupuncture is more satisfactory on sleep anxiety and daytime somnolence .

###24659021
OBJECTIVE	Lenalidomide , a weak substrate of P-glycoprotein ( P-gp ) in vitro , is an oral anticancer drug eliminated predominantly via renal excretion as unchanged compound .
OBJECTIVE	The role of P-gp in lenalidomide disposition and the associated clinical relevance were evaluated .
METHODS	Two phase I , crossover studies were conducted in healthy volunteers .
METHODS	In Study 1 , subjects received lenalidomide ( 10 mg 7 days ) alone or with the P-gp substrate digoxin ( 0.5 mg on Day 5 ) .
METHODS	In Study 2 , subjects received lenalidomide ( a single 25 mg dose ) alone , the P-gp inhibitor quinidine ( 300-600 mg twice-daily 5 days ) plus lenalidomide ( on Day 4 ) , the P-gp inhibitor/substrate temsirolimus ( a single 25 mg dose ) alone , or lenalidomide plus temsirolimus .
METHODS	Pharmacokinetic and safety data were collected for lenalidomide and the co-administrated drugs .
RESULTS	There were no significant changes in the maximum concentration ( C max ) and area under the plasma concentration-time curve ( AUC ) of lenalidomide when co-administered with quinidine , digoxin , or temsirolimus .
RESULTS	Neither the rate nor the capacity of lenalidomide renal excretion was affected by quinidine or temsirolimus , in addition lenalidomide absorption rate and bioavailability remained unchanged .
RESULTS	Furthermore , lenalidomide had no significant effect on blood C max and AUC of temsirolimus and its active metabolite sirolimus ( also a P-gp inhibitor/substrate ) .
RESULTS	The C max of digoxin was slightly higher ( +14 % ) when administered with lenalidomide versus placebo .
RESULTS	There were no other changes in digoxin pharmacokinetics upon co-administration with lenalidomide .
RESULTS	No remarkable safety findings were observed .
CONCLUSIONS	There are no clinically significant pharmacokinetic interactions between lenalidomide and substrates or inhibitors of P-gp .

###25151541
OBJECTIVE	To investigate the effects of a natural oil-based emulsion containing allantoin versus aqueous cream for preventing and managing radiation-induced skin reactions .
METHODS	A total of 174 patients were randomized and participated in the study .
METHODS	Patients received either cream 1 ( the natural oil-based emulsion containing allantoin ) or cream 2 ( aqueous cream ) .
METHODS	Skin toxicity , pain , itching , and skin-related quality of life scores were collected for up to 4 weeks after radiation treatment .
RESULTS	Patients who received cream 1 had a significantly lower average level of Common Terminology Criteria for Adverse Events at week 3 ( P < .05 ) but had statistically higher average levels of skin toxicity at weeks 7 , 8 , and 9 ( all P < .001 ) .
RESULTS	Similar results were observed when skin toxicity was analyzed by grades .
RESULTS	With regards to pain , patients in the cream 2 group had a significantly higher average level of worst pain ( P < .05 ) and itching ( P = .046 ) compared with the cream 1 group at week 3 ; however , these differences were not observed at other weeks .
RESULTS	In addition , there was a strong trend for cream 2 to reduce the incidence of grade 2 or more skin toxicity in comparison with cream 1 ( P = .056 ) .
RESULTS	Overall , more participants in the cream 1 group were required to use another topical treatment at weeks 8 ( P = .049 ) and 9 ( P = .01 ) .
CONCLUSIONS	The natural oil-based emulsion containing allantoin seems to have similar effects for managing skin toxicity compared with aqueous cream up to week 5 ; however , it becomes significantly less effective at later weeks into the radiation treatment and beyond treatment completion ( week 6 and beyond ) .
CONCLUSIONS	There were no major differences in pain , itching , and skin-related quality of life .
CONCLUSIONS	In light of these results , clinicians and patients can base their decision on costs and preferences .
CONCLUSIONS	Overall , aqueous cream seems to be a more preferred option .

###25373314
BACKGROUND	Problem-based learning ( PBL ) is well established in medical education and beyond , and continues to be developed and explored .
BACKGROUND	Challenges include how to connect the somewhat abstract nature of classroom-based PBL with clinical practice and how to maintain learner engagement in the process of PBL over time .
OBJECTIVE	A study was conducted to investigate the efficacy of decision-PBL ( D-PBL ) , a variant form of PBL that replaces linear PBL cases with virtual patients .
OBJECTIVE	These Web-based interactive cases provided learners with a series of patient management pathways .
OBJECTIVE	Learners were encouraged to consider and discuss courses of action , take their chosen management pathway , and experience the consequences of their decisions .
OBJECTIVE	A Web-based application was essential to allow scenarios to respond dynamically to learners ' decisions , to deliver the scenarios to multiple PBL classrooms in the same timeframe , and to record centrally the paths taken by the PBL groups .
METHODS	A randomized controlled trial in crossover design was run involving all learners ( N = 81 ) in the second year of the graduate entry stream for the undergraduate medicine program at St George 's University of London .
METHODS	Learners were randomized to study groups ; half engaged in a D-PBL activity whereas the other half had a traditional linear PBL activity on the same subject material .
METHODS	Groups alternated D-PBL and linear PBL over the semester .
METHODS	The measure was mean cohort performance on specific face-to-face exam questions at the end of the semester .
RESULTS	D-PBL groups performed better than linear PBL groups on questions related to D-PBL with the difference being statistically significant for all questions .
RESULTS	Differences between the exam performances of the 2 groups were not statistically significant for the questions not related to D-PBL .
RESULTS	The effect sizes for D-PBL-related questions were large and positive ( > 0.6 ) except for 1 question that showed a medium positive effect size .
RESULTS	The effect sizes for questions not related to D-PBL were all small ( 0.3 ) with a mix of positive and negative values .
CONCLUSIONS	The efficacy of D-PBL was indicated by improved exam performance for learners who had D-PBL compared to those who had linear PBL .
CONCLUSIONS	This suggests that the use of D-PBL leads to better midterm learning outcomes than linear PBL , at least for learners with prior experience with linear PBL .
CONCLUSIONS	On the basis of tutor and student feedback , St George 's University of London and the University of Nicosia , Cyprus have replaced paper PBL cases for midstage undergraduate teaching with D-PBL virtual patients , and 6 more institutions in the ePBLnet partnership will be implementing D-PBL in Autumn 2015 .

###24534012
OBJECTIVE	The optimal dietary approach for weight loss and improving insulin sensitivity in adolescents is unknown .
OBJECTIVE	This study aimed to explore the association between the estimated insulin demand of the diet , as measured by glycemic and insulin load , weight loss , percentage body fat and insulin sensitivity index ( ISI ) in obese adolescents with clinical features of insulin resistance and/or prediabetes after a 3 month lifestyle and metformin intervention .
METHODS	Secondary data analysis of 91 adolescents ( median age 12.7 years ( range 10.1-17 .4 ) participating in a randomized controlled trial , known as RESIST ; ACTRN12608000416392 .
METHODS	Weight change between baseline and 3 months was measured by BMI expressed as percentage of the 95th centile ( BMI % 95 ) .
METHODS	Body composition was measured by dual energy X-ray absorptiometry and ISI was determined by an oral glucose tolerance test .
RESULTS	Higher dietary glycemic load and insulin load were associated with less weight loss ( BMI % 95 ) , adjusted for sex and pubertal stage , = 0.0466 , P = 0.007 and = 0.0124 , P = 0.040 , respectively .
RESULTS	Inclusion of total energy intake in the model explained observed associations between dietary glycemic load and insulin load and change in BMI % 95 .
RESULTS	Neither dietary glycemic load nor insulin load were associated with changes in percentage body fat or ISI .
RESULTS	Dietary glycemic index and macronutrient content ( % of total energy ) were not associated to changes in BMI % 95 , percentage body fat or ISI .
CONCLUSIONS	Reduced energy diet contributes to weight loss in obese , insulin resistant adolescents .
CONCLUSIONS	Diets with a lower insulin demand were associated with a lower energy intake and may hence assist with weight loss .

###25283350
OBJECTIVE	To investigate the safety of combining a 6-Hz primed low-frequency repetitive transcranial magnetic stimulation ( rTMS ) intervention in the contralesional hemisphere with a modified constraint-induced movement therapy ( mCIMT ) program in children with congenital hemiparesis .
METHODS	Phase 1 randomized , double-blinded , placebo-controlled pretest/posttest trial .
METHODS	University academic facility and pediatric specialty hospital .
METHODS	Subjects ( N = 19 ; age range , 8-17 y ) with congenital hemiparesis caused by ischemic stroke or periventricular leukomalacia .
METHODS	No subject withdrew because of adverse events .
METHODS	All subjects included completed the study .
METHODS	Subjects were randomized to 1 of 2 groups : either real rTMS plus mCIMT ( n = 10 ) or sham rTMS plus mCIMT ( n = 9 ) .
METHODS	Adverse events , physician assessment , ipsilateral hand function , stereognosis , cognitive function , subject report of symptoms assessment , and subject questionnaire .
RESULTS	No major adverse events occurred .
RESULTS	Minor adverse events were found in both groups .
RESULTS	The most common events were headaches ( real : 50 % , sham : 89 % ; P = .14 ) and cast irritation ( real : 30 % , sham : 44 % ; P = .65 ) .
RESULTS	No differences between groups in secondary cognitive and unaffected hand motor measures were found .
CONCLUSIONS	Primed rTMS can be used safely with mCIMT in congenital hemiparesis .
CONCLUSIONS	We provide new information on the use of rTMS in combination with mCIMT in children .
CONCLUSIONS	These findings could be useful in research and future clinical applications in advancing function in congenital hemiparesis .

###25083802
BACKGROUND	Persons with serious mental illnesses ( SMI ) are more likely to die earlier than the general population , primarily due to increased medical burden , particularly from cardiovascular disease ( CVD ) .
BACKGROUND	Life Goals Collaborative Care ( LG-CC ) is designed to improve health outcomes in SMI through self-management , care management , and provider support .
BACKGROUND	This single-blind randomized controlled effectiveness study will determine whether patients with SMI receiving LG-CC compared to usual care ( UC ) experience improved physical health in 12 months .
METHODS	Patients diagnosed with SMI and at least one CVD risk factor receiving care at a VA mental health clinic were randomized to LG-CC or UC .
METHODS	LG-CC included five self-management sessions covering mental health symptom management reinforced through health behavior change , care coordination and health monitoring via a registry , and provider feedback .
METHODS	The primary outcome is change in physical health-related quality of life score ( VR-12 ) from baseline to 12 months .
METHODS	Secondary outcomes include changes in mental health-related quality of life , CVD risk factors ( blood pressure , BMI ) , and physical activity from baseline to 12 months later .
RESULTS	Out of 304 enrolled , 139 were randomized to LG-CC and 145 to UC .
RESULTS	Among patients completing baseline assessments ( N = 284 ) ; the mean age was 55.2 ( SD = 10.9 ; range 28-75 years ) , 15.6 % were women , the majority ( 62 % ) were diagnosed with depression , and the majority ( 63 % ) were diagnosed with hypertension or were overweight ( BMI mean SD = 33.3 6.3 ) .
RESULTS	Baseline VR-12 physical health component score was below population norms ( 50.0 SD = 10 ) at 33.4 11.0 .
CONCLUSIONS	Findings from this trial may inform initiatives to improve physical health for SMI patient populations .

###24418653
OBJECTIVE	Our aim was to identify moderators of the effects of a cognitive behavioral group-based prevention program ( CB group ) and CB bibliotherapy , relative to an educational brochure control condition and to one another , in a school-based effectiveness randomized controlled prevention trial .
METHODS	378 adolescents ( M age = 15.5 , 68 % female ) with elevated depressive symptoms were randomized in one of three conditions and were assessed at pretest , posttest , and 6-month follow-up .
METHODS	We tested the moderating effect of three individual ( baseline depressive symptoms , negative attributional style , substance use ) , three environmental ( negative life events , parental support , peer support ) , and two sociodemographic ( sex , age ) characteristics .
RESULTS	Baseline depressive symptoms interacted with condition and time .
RESULTS	Decomposition indicated that elevated baseline depressive symptoms amplified the effect of CB bibliotherapy at posttest ( but not 6-month follow-up ) relative to the control condition , but did not modify the effect of CB group relative to the control condition or relative to bibliotherapy .
RESULTS	Specifically , CB bibliotherapy resulted in lower posttest depressive symptoms than the control condition in individuals with elevated , but not average or low baseline symptoms .
RESULTS	We found no interaction effect for other putative moderators .
CONCLUSIONS	Our findings suggest that bibliotherapy is effective only in participants who have elevated depressive symptoms at baseline .
CONCLUSIONS	The fact that no study variable moderated the effects of CB group , which had a significant main effect in reducing depressive symptoms relative to the control condition , suggests that this indicated prevention intervention is effective for a wide range of adolescents .

###24853094
BACKGROUND	Vitamin D deficiency is a common problem worldwide .
BACKGROUND	Several studies have shown an association between vitamin D deficiency and the increased risk of metabolic syndrome .
BACKGROUND	No previous study has compared the efficacy and safety of ergocalciferol at 40,000 versus 20,000 IU/week in patients with metabolic syndrome .
OBJECTIVE	To evaluate the efficacy of ergocalciferol supplementation on serum 25-hydroxyvitamin D [ 25 ( OH ) D ] concentrations and to examine safety parameters in metabolic syndrome patients .
METHODS	Outpatient department of Phramongkutklao Hospital , Bangkok , Thailand .
METHODS	A randomized , double-blinded , parallel study was conducted in metabolic syndrome patients with vitamin D deficiency [ 25 ( OH ) D < 20 ng/mL ] .
METHODS	Ninety patients were randomly assigned into three groups of 30 patients each .
METHODS	Group 1 was given two capsules of placebo/week , group 2 was given ergocalciferol 20,000 IU/week , and group 3 was given ergocalciferol 40,000 IU/week for 8 weeks .
METHODS	serum 25 ( OH ) D concentrations , serum calcium , safety , and corrected QT ( QTc ) interval .
RESULTS	Of the 90 patients enrolled , 84 patients completed the study .
RESULTS	At the end of the study , the mean serum 25 ( OH ) D in groups 2 and 3 significantly increased from the baseline ( 15.1 and 14.3 to 26.8 and 30.0 ng/mL , respectively ) .
RESULTS	The increase in serum 25 ( OH ) D in groups 2 and 3 were comparable and significantly greater than that of the placebo group .
RESULTS	The percentage number of patients achieving normal vitamin D levels in groups 1 , 2 and 3 were 3.3 , 33.3 , and 60.0 % , respectively , which were significantly different between groups ( p < 0.001 ) .
RESULTS	Adverse reactions in both ergocalciferol treatment groups were not different from the placebo group ( p > 0.05 ) .
RESULTS	Serum calcium levels did not change within and between groups of treatment .
RESULTS	No significant change in QTc was observed in any patient .
CONCLUSIONS	Both 20,000 and 40,000 IU/week of ergocalciferol supplementation for 8 weeks were able to increase serum 25 ( OH ) D concentrations significantly .
CONCLUSIONS	However , more patients in the ergocalciferol 40,000 IU/week treatment group achieved a normal serum 25 ( OH ) D level than in the group which received 20,000 IU/week .
CONCLUSIONS	Clinicians would have informed of choosing the dosing regimen of ergocalciferol in metabolic syndrome patients .

###25271496
METHODS	Cross-cultural translation , adaptation , and psychometric testing .
OBJECTIVE	To cross-culturally translate and adapt the Roland-Morris Disability Questionnaire ( RMDQ ) into Modern Standard Arabic and examine its validity with Arabic-speaking patients with low back pain ( LBP ) .
BACKGROUND	The English RMDQ is valid , reliable , and commonly used to assess LBP disability in clinical practice and research .
BACKGROUND	There is no valid and reliable version of the RMDQ in Modern Standard Arabic .
METHODS	The RMDQ was forward translated and back translated .
METHODS	An expert committee of musculoskeletal physiotherapists reviewed the translation .
METHODS	Eight patients with LBP evaluated item-by-item comprehensibility .
METHODS	Ten patients piloted the RMDQ for overall comprehensibility and acceptability .
METHODS	Seventeen bilingual patients tested the agreement of the Arabic and English RMDQs .
METHODS	Two-hundred one patients completed the RMDQ and the visual analogue scale .
METHODS	Sixty-four patients were followed-up for test-retest reliability .
RESULTS	Translation of most items was uncontroversial .
RESULTS	The expert committee found the Arabic RMDQ clinically and culturally appropriate .
RESULTS	They reviewed item 11 , addressing bending and kneeling , because this has a clinical significance and cultural/religious implication regarding prayer positions .
RESULTS	All patients reported that it was easy to understand and complete .
RESULTS	The Arabic RMDQ had high overall agreement with the English RMDQ for the global score ( intraclass correlation coefficient [ ICC ] = 0.925 ; 0.811-0 .972 ) .
RESULTS	Kappa statistics showed good item-by-item agreement ( none 0.30 ) .
RESULTS	Mean ( SD ) RMDQ and visual analog scale scores of 201 patients were 10.53 ( 4.80 ) and 5.11 ( 2.28 ) , respectively .
RESULTS	The RMDQ had a low correlation against pain intensity ( r = 0.259 ; P < 0.01 ) .
RESULTS	A Cronbach of 0.729 showed high internal consistency .
RESULTS	Test-retest reliability of the Arabic RMDQ was good ( ICC = 0.900 ; 95 % confidence interval , 0.753-0 .951 ) .
RESULTS	Kappa statistics were high for 18 items and fair for 6 .
CONCLUSIONS	The Arabic version of the RMDQ has good comprehensibility and acceptability , high internal consistency and reliability , low correlation against pain intensity , and good agreement with the English RMDQ .
CONCLUSIONS	We recommend its use with Arabic-speaking patients with LBP .
METHODS	3 .

###25182696
BACKGROUND	Biologic drugs are expensive treatments used in rheumatoid arthritis ( RA ) .
BACKGROUND	Switching among them is common practice in patients who have had an inadequate response or intolerable adverse events .
BACKGROUND	The National Institute of Health and Clinical Excellence ( NICE ) UK , which aims to curtail postcode prescribing , has provided guidance on the sequential prescription of these drugs .
BACKGROUND	This study sought to evaluate the extent to which rheumatology centres across the Midlands were complying with NICE guidance on the switching of biologic drugs in RA , as well as analyse the various prescribing patterns of these drugs .
METHODS	Data was collected via a web-based tool on RA patients who had undergone at least one switch of a biologic drug during 2011 .
METHODS	The standards specified in NICE technology appraisals ( TA130 , TA186 , TA195 , TA198 , and TA225 ) were used to assess compliance with NICE guidance .
METHODS	Descriptive statistical analysis was performed .
RESULTS	There were 335 biologic drug switches in 317 patients .
RESULTS	The most common reason given for switching to a drug was NICE guidelines ( 242 , 72.2 % ) , followed by Physician 's choice ( 122 , 33.4 % ) .
RESULTS	Lack of effect was the most common reason for discontinuing a drug ( 224 , 67 % ) .
RESULTS	For patients on Rituximab , Methotrexate was used in 133 switches ( 76.9 % of the time ) .
RESULTS	Overall NICE compliance for all units was 65 % ( range 50 to 100 % ) , with anti-TNF to anti-TNF switches for inefficacy making up the majority of non-compliant switches .
CONCLUSIONS	This study draws attention to the enigma and disparity of commissioning and prescribing of biologic drugs in RA .
CONCLUSIONS	Currently the evidence would not support switching of a biologic drug for non-clinical purposes such as economic pressures .
CONCLUSIONS	Flexibility in prescribing should be encouraged : biologic therapy should be individualised based on the mode of action and likely tolerability of these drugs .
CONCLUSIONS	Further work should focus on the evidence for using particular sequences of biologic drugs .

###25412569
OBJECTIVE	To determine whether infusions with intravenous immunoglobulin ( IVIg ) during early pregnancy increase live birth rate in women with secondary recurrent miscarriage compared with placebo .
METHODS	A single-centre , randomised , double-blind , placebo-controlled trial .
METHODS	A tertiary centre for recurrent miscarriage in Copenhagen , Denmark .
METHODS	A group of 82 women with unexplained secondary recurrent miscarriage and at least four miscarriages .
METHODS	Women were randomly assigned to repeated infusions with IVIg or placebo ( albumin ) from the time of positive pregnancy test to gestational week 15 or pregnancy loss .
METHODS	Primary outcome was birth with neonatal survival in all randomised women .
RESULTS	In the intention-to-treat analyses , live birth rates were 23/42 ( 54.8 % ) in the IVIg and 20/40 ( 50.0 % ) in the placebo group , relative risk 1.11 ( 95 % CI 0.70-1 .74 ) .
RESULTS	In a per protocol analysis , almost identical results were found .
RESULTS	The median gestational length at delivery was higher in the IVIg than the placebo group ( 282 versus 272 days , P = 0.02 ) but the mean birthweight was not significantly increased .
CONCLUSIONS	In this trial , which is the largest so far , IVIg did not increase the live birth rate in patients with secondary recurrent miscarriage and the treatment can not be recommended in clinical practice .

###24303930
BACKGROUND	Hypertension , hyperlipidemia , and diabetes are significant , but often preventable , contributors to cardiovascular disease ( CVD ) risk .
BACKGROUND	Medication and behavioral nonadherence are significant barriers to successful hypertension , hyperlidemia , and diabetes management .
BACKGROUND	Our objective was to describe the theoretical framework underlying a tailored behavioral and educational pharmacist-administered intervention for achieving CVD risk reduction .
METHODS	Adults with poorly controlled hypertension and/or hyperlipidemia were enrolled from three outpatient primary care clinics associated with the Durham Veterans Affairs Medical Center ( Durham , NC ) .
METHODS	Participants were randomly assigned to receive a pharmacist-administered , tailored , 1-year telephone-based intervention or usual care .
METHODS	The goal of the study was to reduce the risk for CVD through a theory-driven intervention to increase medication adherence and improve health behaviors .
RESULTS	Enrollment began in November 2011 and is ongoing .
RESULTS	The target sample size is 500 patients .
CONCLUSIONS	The Cardiovascular Intervention Improvement Telemedicine Study ( CITIES ) intervention has been designed with a strong theoretical underpinning .
CONCLUSIONS	The theoretical foundation and intervention are designed to encourage patients with multiple comorbidities and poorly controlled CVD risk factors to engage in home-based monitoring and tailored telephone-based interventions .
CONCLUSIONS	Evidence suggests that clinical pharmacist-administered telephone-based interventions may be efficiently integrated into primary care for patients with poorly controlled CVD risk factors .

###24356636
BACKGROUND	Dose-dense weekly paclitaxel ( Taxol ) and carboplatin ( dd-TC ) improved survival compared with conventional tri-weekly paclitaxel and carboplatin ( c-TC ) as a first-line chemotherapy for newly diagnosed stage II-IV ovarian cancer in the Japanese Gynecologic Oncology Group 3016 trial .
BACKGROUND	We report the quality-of-life ( QoL ) results from this trial .
METHODS	A total of 637 patients were randomly assigned to receive c-TC or dd-TC ( c-TC , n = 319 ; dd-TC , n = 312 ) and were asked to complete a QoL assessment at baseline , just after the third and sixth chemotherapy cycles , and at 12 months after randomization .
METHODS	QoL was assessed using Functional Assessment of Cancer Therapy ( FACT ) - general ( FACT-G ) , FACT-taxane subscale ( FACT-T ) , and FACT-ovary subscale ( FACT-Ov ) .
METHODS	The overall QoL and that according to each subscale were analyzed using mixed-effects models adjusted for treatment and time .
RESULTS	Baseline QoL assessment was completed by 204 out of 319 ( 63.9 % ) and 200 out of 312 ( 64.1 % ) patients in the c-TC and dd-TC groups , respectively .
RESULTS	In these groups , the compliance rates with regard to QoL assessment were 74.5 % and 73.0 % , respectively , after three chemotherapy cycles ; 86.8 % and 86.9 % , respectively , after six chemotherapy cycles ; and 74.2 % and 71.6 % , respectively , at 12 months after randomization .
RESULTS	The overall QoL did not differ significantly between the two treatment groups up to 12 months after randomization ( P = 0.46 ) .
RESULTS	However , QoL according to the FACT-T subscale was significantly lower in the dd-TC group than in the c-TC group ( P = 0.02 ) .
CONCLUSIONS	dd-TC does not decrease overall QoL compared with c-TC .

###25399043
OBJECTIVE	The accuracy of physical examination techniques in detecting liver disease is unclear .
OBJECTIVE	We sought to determine the perceived location of the lower liver border via scratch , percussion , palpation and ballottement with novice medical student examiners , compared with ultrasound localisation .
METHODS	Five novice medical students learnt four liver examination techniques and measured the lower liver border in 19 healthy volunteers .
METHODS	The difference between the examination technique and ultrasound ( bias ) and limits of agreement of each method were estimated by mixed linear models and shown using Bland-Altman - like plots .
RESULTS	All techniques had similar bias for the lower liver border , between 1.6 and 1.9 cm superior to the ultrasound measurement .
RESULTS	Percussion had the smallest variability with increasing liver size .
RESULTS	Limits of agreement were wide for all techniques , smallest for palpation ( 6.04 cm ) and largest for scratch ( 7.2 cm ) compared to the mean liver distance of 8 cm .
RESULTS	Conclusion There was no difference in bias between the scratch , percussion , palpation and ballottement techniques regarding the lower liver border .
RESULTS	All techniques had very wide limits of agreement , although palpation had the smallest .
RESULTS	Liver size examination by novice medical students in healthy subjects is unreliable .
RESULTS	Further research is needed using examiners with a different level of expertise and participants of varying body habitus and confirmed liver disease .

###25256937
OBJECTIVE	To evaluate the dose-response relationship of a novel recombinant human FSH ( rhFSH ; FE 999049 ) with respect to ovarian response in patients undergoing IVF/intracytoplasmic sperm injection treatment ; and prospectively study the influence of initial antimllerian hormone ( AMH ) concentrations .
METHODS	Randomized , controlled , assessor-blinded , AMH-stratified ( low : 5.0-14 .9 pmol/L [ 0.7 - < 2.1 ng/mL ] ; high : 15.0-44 .9 pmol/L [ 2.1-6 .3 ng/mL ] ) trial .
METHODS	Seven infertility centers in four countries .
METHODS	Two hundred sixty-five women aged 37 years .
METHODS	Controlled ovarian stimulation with either 5.2 , 6.9 , 8.6 , 10.3 , or 12.1 g of rhFSH , or 11 g ( 150 IU ) of follitropin alfa in a GnRH antagonist cycle .
METHODS	Number of oocytes retrieved .
RESULTS	The number of oocytes retrieved increased in an rhFSH dose-dependent manner , from 5.2 3.3 oocytes with 5.2 g/d to 12.2 5.9 with 12.1 g/d .
RESULTS	The slopes of the rhFSH dose-response curves differed significantly between the two AMH strata , demonstrating that a 10 % increase in dose resulted in 0.5 ( 95 % confidence interval 0.2-0 .7 ) and 1.0 ( 95 % confidence interval 0.7-1 .3 ) more oocytes in the low and high AMH stratum , respectively .
RESULTS	Fertilization rate and blastocyst/oocyte ratio decreased significantly with increasing rhFSH doses in both AMH strata .
RESULTS	No linear relationship was observed between rhFSH dose and number of blastocysts overall or by AMH strata .
RESULTS	Five cases of ovarian hyperstimulation syndrome were reported for the three highest rhFSH doses and in the high AMH stratum .
CONCLUSIONS	Increasing rhFSH doses results in a linear increase in number of oocytes retrieved in an AMH-dependent manner .
CONCLUSIONS	The availability of blastocysts is less influenced by the rhFSH dose and AMH level .
BACKGROUND	NCT01426386 .

###25072441
OBJECTIVE	The aim of this study was to evaluate the feasibility and safety of nonoperative treatment of acute nonperforated appendicitis with antibiotics in children .
METHODS	A pilot randomized controlled trial was performed comparing nonoperative treatment with antibiotics versus surgery for acute appendicitis in children .
METHODS	Patients with imaging-confirmed acute nonperforated appendicitis who would normally have had emergency appendectomy were randomized either to treatment with antibiotics or to surgery .
METHODS	Follow-up was for 1 year .
RESULTS	Fifty patients were enrolled ; 26 were randomized to surgery and 24 to nonoperative treatment with antibiotics .
RESULTS	All children in the surgery group had histopathologically confirmed acute appendicitis , and there were no significant complications in this group .
RESULTS	Two of 24 patients in the nonoperative treatment group had appendectomy within the time of primary antibiotic treatment and 1 patient after 9 months for recurrent acute appendicitis .
RESULTS	Another 6 patients have had an appendectomy due to recurrent abdominal pain ( n = 5 ) or parental wish ( n = 1 ) during the follow-up period ; none of these 6 patients had evidence of appendicitis on histopathological examination .
CONCLUSIONS	Twenty-two of 24 patients ( 92 % ) treated with antibiotics had initial resolution of symptoms .
CONCLUSIONS	Of these 22 , only 1 patient ( 5 % ) had recurrence of acute appendicitis during follow-up .
CONCLUSIONS	Overall , 62 % of patients have not had an appendectomy during the follow-up period .
CONCLUSIONS	This pilot trial suggests that nonoperative treatment of acute appendicitis in children is feasible and safe and that further investigation of nonoperative treatment is warranted .

###24398053
BACKGROUND	The prevalence of sleep disorders increases with age .
BACKGROUND	Sleep disorders may have serious health implications and may be related to serious underlying diseases .
BACKGROUND	Many older people use hypnotics , like benzodiazepines , although these medications have serious side effects and often lead to habituation .
BACKGROUND	Acetaminophen is one of the most frequently used off-label drugs for sleep disorders , although little is known about its effects .
BACKGROUND	Our objective is to investigate whether acetaminophen is effective in treating self-reported sleep disorders in older people .
METHODS	Participants , aged 65 years or older ( n = 150 ) , who have sleep disorders will be randomized for treatment with either acetaminophen 1000 mg or placebo , once daily at bedtime in a double-blind design .
METHODS	Eligible patients should be able to give informed consent , should not be cognitively impaired ( Minimal Mental State Examination ( MMSE ) score20 ) , should not have pain , and should not use acetaminophen on a regular basis because of pain complaints .
METHODS	The study will take three weeks to complete .
METHODS	During these three weeks , the participants register their sleep behavior in a sleep diary .
METHODS	The participants will use the study medication during the second and third week .
METHODS	The primary endpoint will be the self-reported sleep disorders at the end of week three , as measured by means of the Insomnia Severity Index ( ISI ) .
METHODS	To validate these subjective sleep parameters against objectively measured indices of the sleep-wake pattern , we will measure the periods of wakefulness and sleep in a subgroup of participants , using an actigraph worn on the wrist during the entire study period .
CONCLUSIONS	The proposed study will contribute to our knowledge about the treatment of sleep disorders in an older population .
CONCLUSIONS	There is a need for treatments for sleep disorders without serious adverse effects .
CONCLUSIONS	Acetaminophen might be a simple and inexpensive alternative for the regimes that are currently used with older people .
BACKGROUND	The Netherlands National Trial Register NTR2747 .

###25455987
BACKGROUND	Modified vaccinia virus Ankara ( MVA ) is a promising viral vector platform for the development of an H5N1 influenza vaccine .
BACKGROUND	Preclinical assessment of MVA-based H5N1 vaccines showed their immunogenicity and safety in different animal models .
BACKGROUND	We aimed to assess the safety and immunogenicity of the MVA-haemagglutinin-based H5N1 vaccine MVA-H5-sfMR in healthy individuals .
METHODS	In a single-centre , double-blind phase 1/2a study , young volunteers ( aged 18-28 years ) were randomly assigned with a computer-generated list in equal numbers to one of eight groups and were given one injection or two injections intramuscularly at an interval of 4 weeks of a standard dose ( 10 ( 8 ) plaque forming units [ pfu ] ) or a ten times lower dose ( 10 ( 7 ) pfu ) of the MVA-H5-sfMR ( vector encoding the haemagglutinin gene of influenza A/Vietnam/1194 / 2004 virus [ H5N1 subtype ] ) or MVA-F6-sfMR ( empty vector ) vaccine .
METHODS	Volunteers and physicians who examined and administered the vaccine were masked to vaccine assignment .
METHODS	Individuals who received the MVA-H5-sfMR vaccine were eligible for a booster immunisation 1 year after the first immunisation .
METHODS	Primary endpoint was safety .
METHODS	Secondary outcome was immunogenicity .
METHODS	The trial is registered with the Dutch Trial Register , number NTR3401 .
RESULTS	79 of 80 individuals who were enrolled completed the study .
RESULTS	No serious adverse events were identified .
RESULTS	11 individuals reported severe headache and lightheadedness , erythema nodosum , respiratory illness ( accompanied by influenza-like symptoms ) , sore throat , or injection-site reaction .
RESULTS	Most of the volunteers had one or more local ( itch , pain , redness , and swelling ) and systemic reactions ( rise in body temperature , headache , myalgia , arthralgia , chills , malaise , and fatigue ) after the first , second , and booster immunisations .
RESULTS	Individuals who received the 10 ( 7 ) dose had fewer systemic reactions .
RESULTS	The MVA-H5-sfMR vaccine at 10 ( 8 ) pfu induced significantly higher antibody responses after one and two immunisations than did 10 ( 7 ) pfu when assessed with haemagglutination inhibition geometric mean titre at 8 weeks against H5N1 A/Vietnam/1194 / 2004 ( 302 [ SD 38 ] vs 92 [ 23 ] and 1081 [ 24 ] vs 158 [ 32 ] ) .
RESULTS	27 of 39 eligible individuals were enrolled in the booster immunisation study .
RESULTS	A single shot of MVA-H5-sfMR 10 ( 8 ) pfu prime immunisation resulted in higher antibody responses after the booster immunisation than did two shots of MVA-H5-sfMR at the ten times lower dose .
CONCLUSIONS	The MVA-based H5N1 vaccine was well tolerated and immunogenic and therefore the vaccine candidates arising from the MVA platform hold great promise for rapid development in response to a future influenza pandemic threat .
CONCLUSIONS	However , the immunogenicity of this vaccine needs to be compared with conventional H5N1 inactivated non-adjuvanted vaccine candidates in head-to-head clinical trials .
BACKGROUND	European Research Council .

###24389433
BACKGROUND	This two-part phase 2 study evaluated the efficacy and safety of panitumumab , a fully human anti-epidermal growth factor receptor monoclonal antibody , combined with carboplatin/paclitaxel in patients with previously untreated advanced non-small-cell lung cancer .
METHODS	In part 1 , patients were sequentially enrolled to receive paclitaxel 200 mg/m ( 2 ) and carboplatin ( area under the concentration-versus-time curve , 6 mg/min/ml ) plus panitumumab ( 1.0 , 2.0 , or 2.5 mg/kg ) .
METHODS	In part 2 , patients were randomized 2:1 to receive paclitaxel/carboplatin with ( arm A ) or without ( arm B ) the maximum tolerated dose of panitumumab identified in part 1 .
METHODS	Primary endpoints in parts 1 and 2 were the incidence of dose-limiting toxicities and time to progression ( TTP ) , respectively .
RESULTS	In part 1 , four of 19 patients had dose-limiting toxicities : three at 2.0 mg/kg ( fatigue , pain in extremity , dyspepsia ) and one at 2.5 mg/kg ( rash ) .
RESULTS	The maximum tolerated dose was not reached ; panitumumab 2.5 mg/kg was selected for part 2 .
RESULTS	In part 2 , TTP was 18.1 weeks ( 95 % confidence interval [ CI ] , 13.6-23 .3 ) in arm A and 23.0 weeks ( 95 % CI , 15.9-24 .1 ) in arm B ( hazard ratio , 0.9 ; 90 % CI , 0.66-1 .21 ; p = 0.555 ) .
RESULTS	Progression-free survival in arms A and B was 17.6 weeks and 18.3 weeks , respectively , and the objective response rate was 15.2 % and 11.1 % .
RESULTS	Adverse events occurring more frequently in arm A than in arm B included skin toxicity , diarrhea , stomatitis , vomiting , and dizziness .
RESULTS	Exploratory analyses did not demonstrate associations between potential biomarkers and outcomes .
CONCLUSIONS	Although toxicity was predictable and manageable , the addition of panitumumab to paclitaxel/carboplatin did not improve TTP in patients with previously untreated advanced non-small-cell lung cancer .

###25321447
BACKGROUND	Lung volume reduction surgery improves quality of life , exercise capacity , and survival in selected patients but is accompanied by significant morbidity .
BACKGROUND	Bronchoscopic approaches may provide similar benefits with less morbidity .
METHODS	In a randomized , sham procedure controlled , double-blind trial , 277 subjects were enrolled at 36 centers .
METHODS	Patients had emphysema , airflow obstruction , hyperinflation , and severe dyspnea .
METHODS	The primary effectiveness measure was a significant improvement in disease-related quality of life ( St. George 's Respiratory Questionnaire ) and changes in lobar lung volumes .
METHODS	The primary safety measure was a comparison of serious adverse events .
RESULTS	There were 6/121 ( 5.0 % ) responders in the treatment group at 6 months , significantly > 1/134 ( 0.7 % ) in the control group [ Bayesian credible intervals ( BCI ) , 0.05 % , 9.21 % ] .
RESULTS	Lobar volume changes were significantly different with an average decrease in the treated lobes of -224 mL compared with -17 mL for the control group ( BCI , -272 , -143 ) .
RESULTS	The proportion of responders in St. George 's Respiratory Questionnaire was not greater in the treatment group .
RESULTS	There were significantly more subjects with a serious adverse event in the treatment group ( n = 20 or 14.1 % ) compared with the control group ( n = 5 or 3.7 % ) ( BCI , 4.0 , 17.1 ) , but most were neither procedure nor device related .
CONCLUSIONS	This trial had technical and statistical success but partial-bilateral endobronchial valve occlusion did not obtain clinically meaningful results .
CONCLUSIONS	Safety results were acceptable and compare favorably to lung volume reduction surgery and other bronchial valve studies .
CONCLUSIONS	Further studies need to focus on improved patient selection and a different treatment algorithm .
BACKGROUND	ClinicalTrials.gov NCT00475007 .

###26116485
BACKGROUND	Lung volume reduction surgery improves survival in selected patients with emphysema , and has generated interest in bronchoscopic approaches that might achieve the same effect with less morbidity and mortality .
BACKGROUND	Previous trials with endobronchial valves have yielded modest group benefits because when collateral ventilation is present it prevents lobar atelectasis .
METHODS	We did a single-centre , double-blind sham-controlled trial in patients with both heterogeneous emphysema and a target lobe with intact interlobar fissures on CT of the thorax .
METHODS	We enrolled stable outpatients with chronic obstructive pulmonary disease who had a forced expiratory volume in 1 s ( FEV1 ) of less than 50 % predicted , significant hyperinflation ( total lung capacity > 100 % and residual volume > 150 % ) , a restricted exercise capacity ( 6 min walking distance < 450 m ) , and substantial breathlessness ( MRC dyspnoea score 3 ) .
METHODS	Participants were randomised ( 1:1 ) by computer-generated sequence to receive either valves placed to achieve unilateral lobar occlusion ( bronchoscopic lung volume reduction ) or a bronchoscopy with sham valve placement ( control ) .
METHODS	Patients and researchers were masked to treatment allocation .
METHODS	The study was powered to detect a 15 % improvement in the primary endpoint , the FEV1 3 months after the procedure .
METHODS	Analysis was on an intention-to-treat basis .
METHODS	The trial is registered at controlled-trials .
METHODS	com , ISRCTN04761234 .
RESULTS	50 patients ( 62 % male , FEV1 [ % predicted ] mean 317 % [ SD 102 ] ) were enrolled to receive valves ( n = 25 ) or sham valve placement ( control , n = 25 ) between March 1 , 2012 , and Sept 30 , 2013 .
RESULTS	In the bronchoscopic lung volume reduction group , FEV1 increased by a median 877 % ( IQR 227-3585 ) versus 288 % ( 0-851 ) in the control group ( Mann-Whitney p = 00326 ) .
RESULTS	There were two deaths in the bronchoscopic lung volume reduction group and one control patient was unable to attend for follow-up assessment because of a prolonged pneumothorax .
CONCLUSIONS	Unilateral lobar occlusion with endobronchial valves in patients with heterogeneous emphysema and intact interlobar fissures produces significant improvements in lung function .
CONCLUSIONS	There is a risk of significant complications and further trials are needed that compare valve placement with lung volume reduction surgery .
BACKGROUND	Efficacy and Mechanism Evaluation Programme , funded by the Medical Research Council ( MRC ) and managed by the National Institute for Health Research ( NIHR ) on behalf of the MRC-NIHR partnership .

###25553965
OBJECTIVE	To determine the effects of decreased ankle-foot dorsiflexion ( A-Fdf ) range of motion ( ROM ) on gait kinematics in children with spastic cerebral palsy ( SCP ) .
METHODS	All participants were children with spastic cerebral palsy ( n = 10 ) who walked with knee flexion in midstance .
METHODS	Data were collected over 2-5 sessions , at 3-monthly intervals .
METHODS	A-Fdf ROM was quantified using a custom-designed hand-held ankle dynamometer that exerted 4 Nm at the ankle .
METHODS	Ankle-foot and knee angles during gait were quantified on sagittal video recordings .
METHODS	Linear regression ( cross-sectional analysis ) and General Estimation Equation analysis ( longitudinal analysis ) were performed to assess relationships between ( change in ) A-Fdf ROM and ( change in ) ankle-foot and knee angle during gait .
RESULTS	Cross-sectional analysis showed a positive relationship between A-Fdf ROM and both ankle-foot angle in midstance and terminal swing .
RESULTS	Longitudinal analysis showed a positive relationship between individual decreases in A-Fdf ROM and increases of knee flexion during gait ( lowest knee angle in terminal stance and angle in terminal swing ) .
CONCLUSIONS	For this subgroup of SCP children , our results indicate that while changes in ankle angles during gait are unrelated to changes in A-Fdf ROM , changes in knee angles are related to changes in A-Fdf ROM .

###24725276
BACKGROUND	After stroke , pneumonia is a relevant medical complication that can be precipitated by aspiration of saliva , liquids , or solid food .
BACKGROUND	Swallowing difficulty and aspiration occur in a significant proportion of stroke survivors .
BACKGROUND	Cough , an important mechanism protecting the lungs from inhaled materials , can be impaired in stroke survivors , and the likely cause for this impairment is central weakness of the respiratory musculature .
BACKGROUND	Thus , respiratory muscle training in acute stroke may be useful in the recovery of respiratory muscle and cough function , and may thereby reduce the risk of pneumonia .
BACKGROUND	The present study is a pilot study , aimed at investigating the validity and feasibility of this approach by exploring effect size , safety , and patient acceptability of the intervention .
METHODS	Adults with moderate to severe stroke impairment ( National Institutes of Health Stroke Scale ( NIHSS ) score 5 to 25 at the time of admission ) are recruited within 2weeks of stroke onset .
METHODS	Participants must be able to perform voluntary respiratory maneuvers .
METHODS	Excluded are patients with increased intracranial pressure , uncontrolled hypertension , neuromuscular conditions other than stroke , medical history of asthma or chronic obstructive pulmonary disease , and recent cardiac events .
METHODS	Participants are randomized to receive inspiratory , expiratory , or sham respiratory training over a 4-week period , by using commercially available threshold resistance devices .
METHODS	Participants and caregivers , but not study investigators , are blind to treatment allocation .
METHODS	All participants receive medical care and stroke rehabilitation according to the usual standard of care .
METHODS	The following assessments are conducted at baseline , 4weeks , and 12weeks : Voluntary and reflex cough flow measurements , forced spirometry , respiratory muscle strength tests , incidence of pneumonia , assessments of safety parameters , and self-reported activity of daily living .
METHODS	The primary outcome is peak expiratory cough flow of voluntary cough , a parameter indicating the effectiveness of cough .
METHODS	Secondary outcomes are incidence of pneumonia , peak expiratory cough flow of reflex cough , and maximum inspiratory and expiratory mouth pressures .
CONCLUSIONS	Various novel pharmacologic and nonpharmacologic approaches for preventing stroke-associated pneumonia are currently being researched .
CONCLUSIONS	This study investigates a novel strategy based on an exercise intervention for cough rehabilitation .
BACKGROUND	Current Controlled Trials ISRCTN40298220 .

###25262266
BACKGROUND	Bleeding after percutaneous coronary intervention ( PCI ) is more common in women than in men .
BACKGROUND	However , the relationship of sex and bleeding with outcomes is less well studied .
METHODS	We examined the sex-related differences in the incidence of bleeding and its association with in-hospital outcomes among 96,637 patients undergoing PCI enrolled in the BMC2 registry ( 2010-2012 ) .
RESULTS	Women had higher bleeding rate than did men ( 3.9 % vs 1.8 % ) and thus received more blood transfusions ( 59 % vs 41 % ) .
RESULTS	Both men ( odds ratio [ OR ] 2.25 , 95 % CI 1.70-2 .97 ) and women ( OR 3.13 , 95 % CI 2.42-4 .07 ) who bled had higher risk-adjusted death compared with their counterparts without bleeding .
RESULTS	Although there was no difference in adjusted mortality between women and men without bleeding ( OR 1.14 , 95 % CI 0.99-1 .32 ) , among patients who bled , adjusted death was higher in women ( OR 1.28 , 95 % CI 1.11-1 .47 ) .
RESULTS	Among patients with bleeding , transfusion was associated with similar increased risk of death in both men ( OR 2.00 , 95 % CI 1.23-3 .25 ) and women ( OR 2.18 , 95 % CI 1.31-3 .63 ) compared with their counterparts without transfusion ( s ) .
CONCLUSIONS	Post-PCI bleeding was more common and associated with higher-than-expected in-hospital death in women compared with men with bleeding .
CONCLUSIONS	This trend for higher death in women with bleeding was independent of transfusion .
CONCLUSIONS	Quality efforts geared toward reducing bleeding in general , with a special focus on women , need to be explored to help reduce post PCI-bleeding and mortality and decrease sex-related disparity in adverse events .

###24655622
OBJECTIVE	This randomized , double-blind study evaluates the efficacy and tolerability of agomelatine , using fluoxetine as an active comparator , in Asian patients suffering from moderate to severe major depressive disorder ( MDD ) .
METHODS	Patients were randomly assigned to receive either agomelatine ( 25-50mg / day , n = 314 ) or fluoxetine ( 20-40mg / day , n = 314 ) during an 8-week treatment period .
METHODS	The main outcome measure was the change in Hamilton Depression Rating Scale 17 items ( HAM-D17 ) scores .
METHODS	Secondary efficacy criteria included scores on Clinical Global Impression Severity of illness ( CGI-S ) and Improvement of illness ( CGI-I ) , patient sleeping improvement using the self-rating Leeds Sleep Evaluation Questionnaire ( LSEQ ) and anxiety using the Hamilton Anxiety Rating Scale ( HAM-A ) scores .
METHODS	Tolerability and safety evaluations were based on emergent adverse events .
RESULTS	Agomelatine and fluoxetine exert a comparable antidepressant efficacy in the Asian population .
RESULTS	Mean changes over 8 weeks were clinically relevant and similar in both groups ( -14.87.3 and -15.08.1 on HAM-D17 scale in agomelatine and fluoxetine groups , respectively ) .
RESULTS	The between-group difference reached statistical significance on non-inferiority test ( p = 0.015 ) .
RESULTS	Clinically relevant decreases in CGI-S and CGI-I scores were observed over the treatment period in both groups .
RESULTS	The two treatments were equally effective on the symptoms of both anxiety and sleep .
RESULTS	The good tolerability profile and safety of both doses of agomelatine was confirmed in the Asian population .
CONCLUSIONS	Agomelatine and fluoxetine are equally effective in the treatment of MDD-associated symptoms in Asian depressed patients .

###24488324
OBJECTIVE	Icotinib , an oral epidermal growth factor receptor tyrosine kinase inhibitor , has proved effectiveness in xenografted nude mice .
OBJECTIVE	Purpose of the present studies was to investigate tolerability and pharmacokinetics of Icotinib in healthy subjects for the first time , including dose proportionality , food effect , and tolerability .
METHODS	Two studies were conducted in total of 22 healthy subjects : a randomized , two-Latin-square crossover , dose proportional study ( n = 12 ) and a randomized two-way crossover food-effect study ( n = 10 ) .
RESULTS	Plasma concentration of Icotinib reached peak at a median Tmax of 0.75-3 .5 h after single dose and then declined with a mean t1/2 of 6.02-7 .83 h. Over the dose range of 100-600 mg , AUC values were proportional to dose and Cmax showed a slight saturation when dose increases .
RESULTS	Only 0.2 % of the dose was excreted through kidney in unchanged Icotinib .
RESULTS	After dosing 400 mg of Icotinib with high-fat and high-calorie meal , mean Cmax and AUC were significantly increased by 59 and 79 % , respectively .
RESULTS	Three subjects experienced four adverse events ( rash , increase in AST and ALT , and external injury ) .
RESULTS	Rash and increased levels of AST and ALT were considered as drug-related .
RESULTS	No serious adverse events were reported .
CONCLUSIONS	The current work demonstrated that Icotinib was well tolerated in healthy male subjects ( n = 22 ) over the dose range of 100-600 mg with or without food .
CONCLUSIONS	Icotinib exposure , expressed in AUC , was proportionally increased with dose over the above dose range .
CONCLUSIONS	Food intake significantly increased the absorption and exposure of Icotinib in healthy subjects .

###25359159
OBJECTIVE	To compare safety and efficacy of insulin glargine and liraglutide in patients with type 2 diabetes ( T2DM ) .
METHODS	This randomized , multinational , open-label trial included subjects treated for T2DM with metforminsulphonylurea , who had glycated haemoglobin ( HbA1c ) levels of 7.5-12 % .
METHODS	Subjects were assigned to 24weeks of insulin glargine , titrated to target fasting plasma glucose of 4.0-5 .5 mmol/L or liraglutide , escalated to the highest approved clinical dose of 1.8 mg daily .
METHODS	The trial was powered to detect superiority of glargine over liraglutide in percentage of people reaching HbA1c < 7 % .
RESULTS	The mean [ standard deviation ( s.d. ) ] age of the participants was 57 ( 9 ) years , the duration of diabetes was 9 ( 6 ) years , body mass index was 31.9 ( 4.2 ) kg/m ( 2 ) and HbA1c level was 9.0 ( 1.1 ) % .
RESULTS	Equal numbers ( n = 489 ) were allocated to glargine and liraglutide .
RESULTS	Similar numbers of subjects in both groups attained an HbA1c level of < 7 % ( 48.4 vs. 45.9 % ) ; therefore , superiority of glargine over liraglutide was not observed ( p = 0.44 ) .
RESULTS	Subjects treated with glargine had greater reductions of HbA1c [ -1.94 % ( 0.05 ) and -1.79 % ( 0.05 ) ; p = 0.019 ] and fasting plasma glucose [ 6.2 ( 1.6 ) and 7.9 ( 2.2 ) mmol/L ; p < 0.001 ] than those receiving liraglutide .
RESULTS	The liraglutide group reported a greater number of gastrointestinal treatment-emergent adverse events ( p < 0.001 ) .
RESULTS	The mean ( s.d. ) weight change was +2.0 ( 4.0 ) kg for glargine and -3.0 ( 3.6 ) kg for liraglutide ( p < 0.001 ) .
RESULTS	Symptomatic hypoglycaemia was more common with glargine ( p < 0.001 ) .
RESULTS	A greater number of subjects in the liraglutide arm withdrew as a result of adverse events ( p < 0.001 ) .
CONCLUSIONS	Adding either insulin glargine or liraglutide to subjects with poorly controlled T2DM reduces HbA1c substantially , with nearly half of subjects reaching target levels of 7 % .

###24891327
BACKGROUND	The lung volume reduction ( LVR ) coil is a minimally invasive bronchoscopic nitinol device designed to reduce hyperinflation and improve elastic recoil in severe emphysema .
BACKGROUND	We investigated the feasibility , safety and efficacy of LVR coil treatment in a prospective multicentre cohort trial in patients with severe emphysema .
METHODS	Patients were treated in 11 centres .
METHODS	Safety was evaluated by recording all adverse events , efficacy by the St George 's Respiratory Questionnaire ( SGRQ ) as primary endpoint , and pulmonary function testing , modified Medical Research Council dyspnoea score ( mMRC ) and 6-min walk distance ( 6MWD ) up to 12months after the final treatment .
RESULTS	Sixty patients ( 60.97.5 years , forced expiratory volume in 1s ( FEV ( 1 ) ) 30.26.3 % pred ) were bronchoscopically treated with coils ( 55 bilateral , 5 unilateral ) , with a median of 10 ( range 5-15 ) coils per lobe .
RESULTS	Within 30days post-treatment , seven chronic obstructive pulmonary disease exacerbations ( 6.1 % ) , six pneumonias ( 5.2 % ) , four pneumothoraces ( 3.5 % ) and one haemoptysis ( 0.9 % ) occurred as serious adverse events .
RESULTS	At 6 and 12months , respectively , SGRQ was -12.112.9 and -11.113.3 points , 6MWD was +29.774.1 m and +51.476 m , FEV ( 1 ) was +0.110.20 L and +0.110.30 L , and RV ( residual volume ) was -0.650.90 L and -0.710.81 L ( all p < 0.01 ) .
RESULTS	Post hoc analyses showed significant responses for SGRQ , 6MWD and RV in patients with both heterogeneous and homogeneous emphysema .
CONCLUSIONS	LVR coil treatment results in significant clinical improvements in patients with severe emphysema , with a good safety profile and sustained results for up to 1year .
BACKGROUND	NCT01328899 .

###24443783
BACKGROUND	Whole grain ( WG ) options are often limited in schools , which may impact rural , low-income students who rely on school meals for a substantial portion of their food intake .
BACKGROUND	This study examined the changes in the availability and quantity of WG and refined grain foods offered in schools participating in the Creating Healthy , Active and Nurturing Growing-up Environments ( CHANGE ) study , a randomized , controlled intervention among rural communities ( 4 intervention and 4 control ) .
METHODS	Foods were assessed using production records , recipes , and nutrition labels from breakfast and lunch over 1 week during fall 2008 and spring 2009 .
METHODS	Key informant interviews were conducted with school food service directors in the spring 2009 .
RESULTS	The CHANGE intervention schools significantly increased the average percent of school days WGs were offered ( p = .047 ) and the amount of WGs offered/food item ( ounces ) at lunch compared with control schools ( p = .02 ) .
RESULTS	There was a significant decrease in the percent of students with access to refined grains at lunch compared with control schools ( p = .049 ) , although there were no significant differences in WG availability during breakfast .
CONCLUSIONS	The CHANGE schools improved WG availability , enabling student 's WG consumption to be closer to national recommendations .

###24331628
OBJECTIVE	To evaluate the clinical value of iodine [ 131I ] metuximab infusion combined with transcatheter arterial chemoembolization ( TACE ) for treating cases of post-intervention relapse of mid or advanced stage hepatocellular carcinoma ( HCC ) .
METHODS	Sixty patients who were diagnosed between March 2009 and June 2010 with relapse of mid or advanced stage HCC following previous intervention with various standard clinical methods were recruited for study .
METHODS	The patients were randomly and equally divided into a control treatment group ( CG ; receiving TACE therapy alone ) and an experimental treatment group ( TG ; receiving TACE combined with iodine [ 131I ] metuximab injection ) .
METHODS	For all patients , licartin was first perfused into the tumor feeding artery and then the TACE procedure was performed 20 min later .
METHODS	Liver function markers and routine blood parameters , including alpha-fetoprotein ( AFP ) and clotting time , were examined at one week and one month after the treatment .
METHODS	Enhanced computed tomography or magnetic resonance imaging of the liver was performed at one month after treatment and thereafter on a bi-monthly follow-up schedule .
METHODS	The World Health Organization 's tumor evaluation standard was used to assess the therapeutic effects in each group .
METHODS	Results of laboratory tests ( pre - and post-treatment ) , reported complications , and side-effects were evaluated for their contributions to time of tumor progression ( TTP ) and survival time .
RESULTS	Patients in the TG and CG groups had similar blood cell counts at pre-operative and 1-week postoperative time points .
RESULTS	The TG group showed a significantly reduced level of AFP following treatment , but it was not significantly different from the level in the CG group .
RESULTS	The TG group did however show significantly different levels of liver functional parameters ( all P less than 0.05 ) and significantly higher TTP ( 4.84 + / -4.11 vs. CG : 2.54 + / -2.08 months ; t = -2.13 , P less than 0.05 ) and average survival time ( 7.05 vs. 5.15 months ; x2 = 4.24 , P = 0.039 ) .
RESULTS	The rates of partial response ( PR ) , slight remission ( MR ) , unchanged status ( SD ) and progressive disease ( PD ) were 16.7 % , 37.5 % , 25.0 % and 20.8 % in the TG group , and 8.7 % , 17.4 % , 21.7 % and 52.2 % in the CG group .
RESULTS	The therapeutic effect rate ( CR + PR + MR ) and reaction rate ( CR + PR + MR + SD ) was significantly different between the two groups ( P = 0.048 ) .
RESULTS	No serious adverse effects were reported .
CONCLUSIONS	TACE combined with iodine [ 131I ] metuximab injection is a safe and effective procedure for prolonging the survival and TTP of patients with HCC relapse following prior therapeutic intervention .

###24894625
OBJECTIVE	Nicotine vaccination has been proposed as a possible treatment to aid smoking cessation .
OBJECTIVE	First efficacy results of the nicotine vaccine 3 ' - AmNic-rEPA ( NicVAX ) showed that only a subgroup of the top 30 % antibody responders achieved higher abstinence rates than placebo .
OBJECTIVE	The present study examined the efficacy of adding NicVAX versus placebo to varenicline and behavioural support as an aid in smoking cessation and relapse prevention .
METHODS	Randomized placebo-controlled trial .
METHODS	Two research centres ( Maastricht University Medical Centre and Slotervaart Hospital ) in the Netherlands .
METHODS	A total of 558 smokers were assigned randomly to six injections with NicVAX ( n = 278 ) or placebo ( n = 280 ) both co-administered with open label varenicline and behavioural support .
METHODS	Outcomes were prolonged carbon monoxide-validated abstinence from weeks 9 to 52 ( primary ) and weeks 37 to 52 ( secondary ) .
METHODS	We also performed a pre-planned subgroup analysis in the top 30 % antibody responders .
RESULTS	There was no difference in abstinence rates between NicVAX and placebo from weeks 9 to 52 [ 27.7 versus 30.0 % , odds ratio ( OR ) = 0.89 , 95 % confidence interval ( CI ) = 0.62-1 .29 ] or weeks 37 to 52 ( 33.8 versus 33.2 % , OR = 1.03 , 95 % CI = 0.73-1 .46 ) .
RESULTS	The top 30 % antibody responders , compared to the placebo group , showed a non-significant tendency towards higher abstinence rates from weeks 37 to 52 ( 42.2 versus 33.2 % , OR = 1.47 , 95 % CI = 0.89-2 .42 ) .
CONCLUSIONS	The nicotine vaccine , NicVAX , does not appear to improve the chances of stopping smoking when given in addition to varenicline and behavioural support .

###24797449
BACKGROUND	Acting coherently upon stimuli requires some kind of integration of stimulus and response features across various distinct cortical feature maps ( one aspect of the binding problem ) .
BACKGROUND	Although the process of feature binding proper seems rather automatic , recent studies revealed that the management of stimulus-response bindings is less efficient in populations with impaired cognitive-control processes .
OBJECTIVE	Here , we investigated whether the cognitive control of stimulus-response feature bindings ( `` event files '' ) in healthy participants is affected by non-invasive brain stimulation ( tDCS ) of the dorsolateral prefrontal cortex ( DLPFC ) - a main component of the cognitive-control network .
METHODS	In different sessions , participants received anodal , cathodal , or sham tDCS ( 2 mA , 20 min ) while performing an audio-visual event-file task assessing the creation and retrieval of stimulus-stimulus and stimulus-response feature bindings .
METHODS	The general findings from this task indicate that performance suffers when some , but not all of the features are repeated ( the so-called partial repetition cost ) .
RESULTS	Stimulation over the right , but not the left DLPFC reduced control of stimulus-response bindings and produced outcome patterns similar to those previously observed in autistic children , people with lower fluid intelligence , and older adults .
CONCLUSIONS	This finding provides empirical support for a role of the right DLPFC in feature-binding management , which might consist in preventing the stimulus-induced activation of previously created , but now task-irrelevant , episodic bindings .
CONCLUSIONS	From a methodological perspective , the finding may suggest that tDCS could be used as a temporary , reversible `` brain lesion '' generator in healthy subjects , enabling experimental investigation of how the brain works .

###24708422
OBJECTIVE	To assess in a randomized study the patient-centred outcome of two guided surgery systems ( mucosa or bone supported ) compared to conventional implant placement , in fully edentulous patients .
METHODS	Fifty-nine patients ( 72 jaws ) with edentulous maxillas and / or mandibles , were consecutively recruited and randomly assigned to one of the treatment groups .
METHODS	Outcome measures were the Dutch version of the McGill Pain Questionnaire ( MPQ-DLV ) , the Health-related quality of life instrument ( HRQOL ) , visual analogue scales ( VAS ) , the duration of the procedure , and the analgesic doses taken each day .
RESULTS	Three hundred and fourteen implants were placed successfully .
RESULTS	No statistical differences could be shown between treatment groups on pain response ( MPQ-DLV ) , treatment perception ( VAS ) or number or kind of pain killers .
RESULTS	For the HRQOLI-instrument , a significant difference was found between the Materialise Mucosa and Materialise Bone group at day 1 ( p = 0.02 ) and day 2 ( p = 0.01 ) .
RESULTS	For the duration of the surgery , a statistical difference ( p = 0.005 ) was found between the Materialise mucosa and the Mental group , in favour of the first .
CONCLUSIONS	In this study little difference could be found in the patient outcome variables of the different treatment groups .
CONCLUSIONS	However there was a tendency for patients treated with conventional flapped implant placement to experience the pain for a longer period of time .

###25239088
BACKGROUND	The snatch-farrowed porcine-colostrum-deprived ( SF-pCD ) pig model , in which neonates are raised on commercially available bovine colostrum , is an alternative model for porcine infectious disease research .
BACKGROUND	It is not known if SF-pCD pigs possess growth performance and immunity comparable to conventional , farm-raised pigs .
BACKGROUND	The current experiment compared growth performance and immune responses of SF-pCD pigs to their farm-raised siblings following Mycoplasma hyopneumoniae ( Mhyo ) vaccination .
BACKGROUND	Twelve SF-pCD and 13 farm-raised siblings were vaccinated on day 7 ( D7 ) and D26 of age .
BACKGROUND	Body weights were measured once or twice weekly and average daily gain ( ADG ) was calculated .
BACKGROUND	Peripheral blood mononuclear cells ( PBMC ) were isolated on D40 .
BACKGROUND	Cytokine secretion from PBMC stimulated with Mhyo antigen or phorbol myristate acetate plus ionomycin ( PMA/Iono ) was assessed using a multiplexed fluorescent microsphere immunoassay ( FMIA ) .
BACKGROUND	Additionally , interferon gamma ( IFN ) secretion from stimulated PBMC was assessed using ELISPOT .
BACKGROUND	Mhyo IgG titers were measured by an ELISA in D40 sera .
RESULTS	Growth performance did not differ between groups before weaning , but SF-pCD pigs had higher ADG after weaning .
RESULTS	In response to Mhyo stimulation , numbers of IFN secreting PBMC and levels of interleukin 8 ( IL8 ) and IL10 in PBMC supernatants were significantly higher in SF-pCD pigs , as were Mhyo antibody levels in sera , and levels of IL1 , IL8 and IL12 in supernatants of PMA/Iono stimulated PBMC .
CONCLUSIONS	Under the conditions of this experiment , SF-pCD pigs demonstrated superior growth performance and enhanced humoral and cell-mediated immunity following vaccination .
CONCLUSIONS	Whether or not this reflects greater resistance or tolerance to infection is unknown but the ability to react positively to the vaccination provides evidence that SF-pCD pigs are a suitable alternative model for swine disease research .

###25381629
BACKGROUND	Physical exercise is associated with enhanced production of reactive oxygen species , which if uncontrolled can result in tissue injury .
BACKGROUND	Phosphodiesterase type 5 inhibitors ( PDE5i ) exhibit protective effect against oxidative stress , both in animals and healthy/unhealthy humans .
BACKGROUND	However , the effect of a chronic administration of PDE5i , particularly combined with physical exercise , has never been investigated .
OBJECTIVE	The present study was designed to evaluate the effect of the long-acting PDE5i tadalafil on oxidative status and muscle damage after exhaustive exercise in healthy males included in a double-blind crossover trial .
OBJECTIVE	Tadalafil , having a putative antioxidant activity , may reduce oxidative damage after strenuous exercise .
METHODS	Each volunteer randomly received two tablets of placebo or tadalafil ( 20 mg/day ) with 36 h of interval before performing exhaustive exercise .
METHODS	After 2 weeks of washout , the volunteers were crossed over .
METHODS	Blood samples were collected immediately before exercise , immediately after , and during recovery ( 15 , 30 , 60 min ) .
METHODS	Plasma total antioxidant status , glutathione homeostasis ( GSH/GSSG ) , malondialdehyde ( MDA ) , protein carbonyls , creatine kinase ( CK ) , lactate dehydrogenase ( LDH ) and the inflammatory cytokine interleukin 6 were assessed .
RESULTS	Tadalafil administration per se affected redox homeostasis ( GSH/GSSG -36 % ; p < 0.05 ) , cellular ( CK +75 % and LDH +36 % ; p < 0.05 ) and oxidative damage ( MDA +41 % and protein carbonyls +50 % ; p < 0.05 ) markers .
RESULTS	The exhaustive exercise increased all the above-reported biochemical parameters , with subjects from the tadalafil group showing significantly higher values with respect to the placebo group .
CONCLUSIONS	A prolonged exposure to tadalafil decreases antioxidant capacity at resting condition , therefore making subjects more susceptible to the oxidative stress induced by an exhaustive bout of exercise .

###25509727
OBJECTIVE	To compare the clinical efficacy difference between electroacupuncture ( EA ) at qijie area combined with spine balance-regulating massage and medication for posterior circulation ischemia ( PCI ) .
METHODS	One hundred cases of PCI were randomly divided into a treatment group ( 50 cases ) and a medication group ( 50 cases ) .
METHODS	The treatment group was treated with EA at Baihui ( GV 20 ) , Sishencong ( EX-HN 1 ) , Fengchi ( GB 20 ) , Shenshu ( BL 23 ) , Danzhong ( CV 17 ) , etc. in qijie area combined with spine muscle-relieving massage and comprehensive chiropractic .
METHODS	The medication group was treated with oral administration of nimodipine ( 30 mg per time , three treatments per day ) and vinpocetine injection with 500 mL of glucose injection or intravenous drip of 500 mL 0.9 % sodium chloride injection , once a day .
METHODS	Ten treatments were taken as one course in both groups , and two courses were given .
METHODS	The symptom score , mean resistance index ( RI ) of vertebral artery ( VA ) and basilar artery ( BA ) , mean velocity of blood flow ( Vm ) and comprehensive clinical efficacy were compared before and after treatment in two groups .
RESULTS	The cured and markedly effective rate was 79.6 % ( 39/49 ) in the treatment group , which was superior to 54.7 % ( 23/42 ) in the medication group ( P < 0.05 ) .
RESULTS	The symptom score was both significantly improved after treatment in two groups ( both P < 0.05 ) , which was more obvious in the treatment group ( P < 0.05 ) .
RESULTS	The RI of VA and BA , Vm of VA and BA were significantly improved after treatment in two groups ( all P < 0.05 ) , which were more obvious in the treatment group ( all P < 0.05 ) .
CONCLUSIONS	The electroacupuncture combined with spine balance-regulating massage has superior effect on improving mean velocity of blood flow and resistance index of vertebral artery and basilar artery as well as symptom score to medication , and is believed to be a safe and effective treatment for posterior circulation ischemia .

###24841733
OBJECTIVE	To determine the safety and effectiveness of intralesional tetracycline 2 % injection for the treatment of lower eyelid festoons .
METHODS	The authors retrospectively reviewed the charts of all patients undergoing tetracycline 2 % injection of lower eyelid festoons at the Cole Eye Institute from August 2008 to August 2013 .
METHODS	Charts were reviewed for patient demographic data , dose and number of tetracycline injections , follow-up interval , the presence of preinjection and postinjection photographs , and complications .
METHODS	Charts without preinjection and postinjection photographs were excluded from review .
METHODS	The preinjection and postinjection photographs were randomized , masked , and graded by 4 independent examiners .
METHODS	Photographs were graded on a scale of 0 ( no festoon ) to 4 ( severe festoon ) .
METHODS	Student t test was used for statistical analysis .
RESULTS	Eleven patients met inclusion criteria .
RESULTS	Each patient underwent bilateral injection .
RESULTS	Average follow up was 121 days ( range , 18-586 days ) .
RESULTS	Patients received up to 0.75 ml ( mean , 0.24 ml ) of tetracycline 2 % per side .
RESULTS	Average preinjection grade was 2.1 ( standard deviation , 0.89 ; range , 0-3 ) , and average postinjection grade was 1.2 ( standard deviation , 0.72 ; range , 0-2 ; p < 0.001 ) .
RESULTS	Three patients had follow up less than 60 days ( mean , 34 days ) , with an average preinjection grade of 1.96 and postinjection grade of 1.23 ( p < 0.001 ) .
RESULTS	Five patients had follow up between 60 and 100 days ( mean , 82 days ) , with an average preinjection grade of 2.18 and postinjection grade of 1.38 ( p < 0.001 ) .
RESULTS	Three patients had follow up longer than 100 days ( mean , 275 days ) , with an average preinjection grade of 2.08 and postinjection grade of 0.78 ( p < 0.001 ) .
RESULTS	Complications other than pain and bruising were not identified in any patient .
CONCLUSIONS	Intralesional tetracycline 2 % injection may offer a safe option to treat lower eyelid festoons .
CONCLUSIONS	Complications such as cutaneous ischemia or necrosis were not identified in any patient .
CONCLUSIONS	Further study may determine optimal treatment doses and intervals and detect infrequent but significant complications .

###24450968
BACKGROUND	The Quality and Outcomes Framework in the United Kingdom ( UK ) National Health Service previously highlighted case finding of depression amongst patients with diabetes or coronary heart disease .
BACKGROUND	However , depression in older people remains under-recognized .
BACKGROUND	Comprehensive data for analyses of the association of depression in older age with other health and functional measures , and demographic factors from community populations within England , are lacking .
METHODS	Secondary analyses of cross-sectional baseline survey data from the England arm of a randomised controlled trial of health risk appraisal for older people in Europe ; PRO-AGE study .
METHODS	Data from 1085 community-dwelling non-disabled people aged 65 years or more from three group practices in suburban London contributed to this study .
METHODS	Depressed mood was ascertained from the 5-item Mental Health Inventory Screening test .
METHODS	Exploratory multivariable logistic regression was used to identify the strongest associations of depressed mood with a previous diagnosis of a specified physical/mental health condition , health and functional measures , and demographic factors .
RESULTS	Depressed mood occurred in 14 % ( 155/1085 ) of participants .
RESULTS	A previous diagnoses of depression ( OR 3.39 ; P < 0.001 ) and poor vision as determined from a Visual Function Questionnaire ( OR 2.37 ; P = 0.001 ) were amongst the strongest factors associated with depressed mood that were independent of functional impairment , other co-morbidities , and demographic factors .
RESULTS	A subgroup analyses on those without a previous diagnosis of depression also indicated that within this group , poor vision ( OR 2.51 ; P = 0.002 ) was amongst the strongest independent factors associated with depressed mood .
CONCLUSIONS	Previous case-finding strategies in primary care focussed on heart disease and diabetes but health-related conditions other than coronary heart disease and diabetes are also associated with an increased risk for depression .
CONCLUSIONS	Complex issues of multi-morbidity occur within aging populations .
CONCLUSIONS	` Risk ' factors that appeared stronger than those , such as , diabetes and coronary heart disease that until recently prompted for screening in the UK due to the QOF , were identified , and independent of other morbidities associated with depressed mood .
CONCLUSIONS	From the health and functional factors investigated , amongst the strongest factors associated with depressed mood was poor vision .
CONCLUSIONS	Consideration to case finding for depressed mood among older people with visual impairment might be justified .

###25684217
OBJECTIVE	To examine the association between preoperative quality of life ( QoL ) and postoperative adverse events in women treated for endometrial cancer .
METHODS	760 women with apparent Stage I endometrial cancer were randomised into a clinical trial evaluating laparoscopic versus open surgery .
METHODS	This analysis includes women with preoperative QoL measurements , from the Functional Assessment of Cancer Therapy-General ( FACT-G ) questionnaire , and who were followed up for at least 6 weeks after surgery ( n = 684 ) .
METHODS	The outcomes for this study were defined as ( 1 ) the occurrence of moderate to severe adverse events within 6 months ( Common Toxicology Criteria ( CTC ) grade3 ) ; and ( 2 ) any serious adverse event ( SAE ) .
METHODS	The association between preoperative QoL and the occurrence of AE was examined , after controlling for baseline comorbidity and other factors .
RESULTS	After adjusting for other factors , odds of occurrence of AE of CTC grade3 were significantly increased with each unit decrease in baseline FACT-G score ( OR = 1.02 , 95 % CI 1.00-1 .03 , p = 0.030 ) , which was driven by physical well-being ( PWB ) ( OR = 1.09 , 95 % CI 1.04-1 .13 , p = 0.0002 ) and functional well-being subscales ( FWB ) ( OR = 1.04 , 95 % CI 1.00-1 .07 , p = 0.035 ) .
RESULTS	Similarly , odds of SAE occurrence were significantly increased with each unit decrease in baseline FACT-G score ( OR = 1.02 , 95 % CI 1.01-1 .04 , p = 0.011 ) , baseline PWB ( OR = 1.11 , 95 % CI 1.06-1 .16 , p < 0.0001 ) or baseline FWB subscales ( OR = 1.05 , 95 % CI 1.01-1 .10 , p = 0.0077 ) .
CONCLUSIONS	Women with early endometrial cancer presenting with lower QoL prior to surgery are at higher risk of developing a serious adverse event following surgery .
BACKGROUND	Cancer Council Queensland , Cancer Council New South Wales , Cancer Council Victoria , Cancer Council , Western Australia ; NHMRC project grant 456110 ; Cancer Australia project grant 631523 ; The Women and Infants Research Foundation , Western Australia ; Royal Brisbane and Women 's Hospital Foundation ; Wesley Research Institute ; Gallipoli Research Foundation ; Gynetech ; TYCO Healthcare , Australia ; Johnson and Johnson Medical , Australia ; Hunter New England Centre for Gynaecological Cancer ; Genesis Oncology Trust ; and Smart Health Research Grant QLD Health .

###24628565
OBJECTIVE	Since there is a lack of current evidence to support the compatibility of the most commonly used arterial blood gas syringes with the latest multi-parameter analyzers , the objective of this study was to assess the agreement of analyte values between three heparinized arterial blood gas syringes using three different analyzers .
METHODS	Venous blood from 25 healthy volunteers was drawn into the study syringes ( BD Drihep A-Line , PICO50 , and Portex Line Draw Plus ) by four clinician volunteers in a random order ( 441 total ) and immediately ( < 15 minutes ) analyzed ( ABL800 FLEX , RAPIDPoint 500 , i-STAT System ) in a randomized order .
METHODS	The Bland-Altman method was used to assess agreement of analyte values between the syringes for each analyzer .
METHODS	The results by analyte and analyzer were compared across syringes using one-way ANOVA , and Tukey 's approach was used to identify statistically significant differences between pairs of syringes .
RESULTS	Comparison of the syringes ' mean differences and standard deviations showed close agreement for all three analyzers .
RESULTS	There were no statistically significant differences between syringes in 14 of the analytes for any of the analyzers ( p > 0.05 ) .
RESULTS	For RAPIDPoint and i-STAT , the Ca ( 2 + ) value was significantly less for A-Line than for the other syringes .
RESULTS	The value for Na ( + ) was significantly greater for the PICO50 than the A-Line and Line Draw syringes with the i-STAT .
RESULTS	Both results were within two standard deviations of the mean of the other two syringes and are not considered clinically significant ; however , comparisons were not made between the values from the different analyzers .
CONCLUSIONS	Dry-balanced lithium heparin ABG syringes used for blood draws should provide reliable results , regardless of syringe type , provided that the clinicians use proper pre-analytical techniques .

###24975853
BACKGROUND	Pancreaticoduodenectomy ( PD ) is associated with a high incidence of postoperative complications including pancreatic fistula .
BACKGROUND	This randomized clinical trial compared the incidence of pancreatic fistula between the isolated Roux-en-Y ( IsoRY ) and conventional reconstruction ( CR ) methods .
METHODS	Patients admitted for PD between June 2009 and September 2012 in a single centre were assigned randomly to CR or IsoRY .
METHODS	The primary endpoint was the incidence of pancreatic fistula ( grade A-C ) defined according to the International Study Group on Pancreatic Fistula .
METHODS	Secondary endpoints were complication rates , mortality and hospital stay .
METHODS	Multiple logistic regression analysis was performed to identify factors associated with pancreatic fistula .
RESULTS	Some 153 patients were randomized , 76 to CR and 77 to IsoRY ; two patients from the IsoRY group were excluded after randomization .
RESULTS	Pancreatic fistula occurred in 26 patients ( 34 per cent ) in the CR group and 25 ( 33 per cent ) in the IsoRY group ( P = 0909 ) .
RESULTS	The number of patients with a clinically relevant pancreatic fistula ( grade B or C ) was similar in the two groups ( 10 and 11 patients respectively ; P = 0789 ) , as were complication rates ( 42 versus 40 per cent ; P = 0793 ) and mortality ( none in either group ; P = 0999 ) .
RESULTS	Soft pancreas was the only independent risk factor for pancreatic fistula ( odds ratio 442 , 95 per cent confidence interval 185 to 1053 ; P < 0001 ) .
CONCLUSIONS	This study showed that IsoRY reconstruction does not reduce the incidence of pancreatic fistula compared with CR .
BACKGROUND	NCT00915863 ( http://www.clinicaltrials.gov/ ) and UMIN000001967 ( http://www.umin.ac.jp/ ) .

###25554404
BACKGROUND	Cardiomyopathy is a leading cause of death in patients with Duchenne muscular dystrophy and myocardial damage precedes decline in left ventricular systolic function .
BACKGROUND	We tested the efficacy of eplerenone on top of background therapy in patients with Duchenne muscular dystrophy with early myocardial disease .
METHODS	In this randomised , double-blind , placebo-controlled trial , boys from three centres in the USA aged 7 years or older with Duchenne muscular dystrophy , myocardial damage by late gadolinium enhancement cardiac MRI and preserved ejection fraction received either eplerenone 25 mg or placebo orally , every other day for the first month and once daily thereafter , in addition to background clinician-directed therapy with either angiotensin-converting enzyme inhibitors ( ACEI ) or angiotensin receptor blockers ( ARB ) .
METHODS	Computer-generated randomisation was done centrally using block sizes of four and six , and only the study statistician and the investigational pharmacy had the preset randomisation assignments .
METHODS	The primary outcome was change in left ventricular circumferential strain ( Ecc ) at 12 months , a measure of contractile dysfunction .
METHODS	Safety was established through serial serum potassium levels and measurement of cystatin C , a non-creatinine measure of kidney function .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01521546 .
RESULTS	Between Jan 26 , 2012 , and July 3 , 2013 , 188 boys were screened and 42 were enrolled .
RESULTS	20 were randomly assigned to receive eplerenone and 22 to receive placebo , of whom 20 in the eplerenone group and 20 in the placebo group completed baseline , 6-month , and 12-month visits .
RESULTS	After 12 months , decline in left ventricular circumferential strain was less in those who received eplerenone than in those who received placebo ( median Ecc 10 [ IQR 03-22 ] vs 22 [ 13-31 ] ; p = 0020 ) .
RESULTS	Cystatin C concentrations remained normal in both groups , and all non-haemolysed blood samples showed normal potassium concentrations .
RESULTS	One 23-year-old patient in the placebo group died of fat embolism , and another patient in the placebo group withdrew from the trial to address long-standing digestive issues .
RESULTS	All other adverse events were mild : short-lived headaches coincident with seasonal allergies occurred in one patient given eplerenone , flushing occurred in one patient given placebo , and anxiety occurred in another patient given placebo .
CONCLUSIONS	In boys with Duchenne muscular dystrophy and preserved ejection fraction , addition of eplerenone to background ACEI or ARB therapy attenuates the progressive decline in left ventricular systolic function .
CONCLUSIONS	Early use of available drugs warrants consideration in this population at high risk of cardiac death , but further studies are needed to determine the effect of combination cardioprotective therapy on event-free survival in Duchenne muscular dystrophy .
BACKGROUND	BallouSkies , Parent Project for Muscular Dystrophy , US National Center for Advancing Translational Sciences , and US National Institutes of Health .

###24756122
OBJECTIVE	To monitor corneal epithelial healing under bandage contact lens ( BCL ) using ultrahigh-resolution optical coherence tomography ( UHR-OCT ) after pterygium surgery .
METHODS	Thirty-nine eyes of 39 patients undergoing pterygium excision and conjunctival autografting were randomly allocated into 2 groups : 20 eyes were covered with silicone hydrogel BCLs at the end of surgery and 19 eyes served as a control .
METHODS	Ultrahigh-resolution optical coherence tomography scans of the cornea were performed sequentially at 1 , 2 , and 3 days , and then every other day until the end of re-epithelialization after surgery .
METHODS	Complete epithelial healing was verified with fluorescein staining examination after removal of BCLs .
METHODS	Postsurgery pain was evaluated using the visual analog scale .
RESULTS	All BCLs were successfully fit without any contact lens-related complications .
RESULTS	Ultrahigh-resolution optical coherence images clearly revealed the architectural features of postoperative cornea with BCL in situ and showed epithelial healing process .
RESULTS	Ultrahigh-resolution optical coherence tomography imaging agreed with the fluorescein staining examinations in detecting corneal epithelial defect .
RESULTS	Based on the assessment by UHR-OCT , the average time course of re-epithelialization in the BCL group was 3.91.2 days , whereas in the control group , it was 5.71.8 days ( P = 0.001 ) .
RESULTS	Visual analog scale scoring showed lower pain levels in the BCL group comparing with the control group at each point of time ( all P < 0.05 ) .
CONCLUSIONS	Ultrahigh-resolution optical coherence tomography is an excellent tool in monitoring corneal epithelial healing under BCLs and determining the appropriate time for lens removal .
CONCLUSIONS	Silicone hydrogel BCL is recommended as an adjuvant therapy after pterygium surgery for its efficacy in improving re-epithelialization and postoperative comfort .

###25389283
BACKGROUND	The Zwolle Risk Score ( ZRS ) identifies ST-elevation myocardial infarction ( STEMI ) patients treated with primary percutaneous coronary intervention ( PPCI ) eligible for early discharge .
BACKGROUND	We aimed to investigate whether baseline N-terminal pro-brain natriuretic peptide ( NT-proBNP ) is also able to identify these patients and could improve future risk strategies .
RESULTS	PPCI patients included in the Ongoing Tirofiban in Myocardial Infarction Evaluation ( On-TIME ) II study were candidates ( N = 861 ) .
RESULTS	We analyzed whether ZRS and baseline NT-proBNP predicted 30-day mortality and assessed the occurrence of major adverse cardiac events ( MACEs ) and major bleeding .
RESULTS	Receiver operating characteristic curve analysis was used to assess discriminative accuracy for ZRS , NT-pro-BNP , and their combination .
RESULTS	After multiple imputation , 845 patients were included .
RESULTS	Both ZRS > 3 ( hazard ratio [ HR ] = 9.42 ; P < 0.001 ) and log NT-pro-BNP ( HR = 2.61 ; P < 0.001 ) values were associated with 30-day mortality .
RESULTS	On multivariate analysis , both the ZRS ( HR = 1.41 ; 95 % confidence interval [ CI ] = 1.27 to 1.56 ; P < 0.001 ) and log NT-proBNP ( HR = 2.09 ; 95 % CI = 1.59 to 2.74 ; P < 0.001 ) independently predicted death at 30 days .
RESULTS	The area under the curve for 30-day mortality for combined ZRS/NT-proBNP was 0.94 ( 95 % CI = 0.90 to 0.99 ) , with optimal predictive values of a ZRS 2 and a NT-proBNP value of 200 pg/mL .
RESULTS	Using these cut-off values , 64 % of the study population could be identified as very low risk with zero mortality at 30 days follow-up and low occurrence of MACEs and major bleeding between 48 hours and 10 days ( 1.3 % and 0.6 % , respectively ) .
CONCLUSIONS	Baseline NT-proBNP identifies a large group of low-risk patients who may be eligible for early ( 48 - to 72-hour ) discharge , whereas optimal predictive accuracy is reached by the combination of both baseline NT-proBNP and ZRS .

###24842135
OBJECTIVE	Small trials suggest that postoperative outcomes may be improved by the use of cardiac output monitoring to guide administration of intravenous fluid and inotropic drugs as part of a hemodynamic therapy algorithm .
OBJECTIVE	To evaluate the clinical effectiveness of a perioperative , cardiac output-guided hemodynamic therapy algorithm .
METHODS	OPTIMISE was a pragmatic , multicenter , randomized , observer-blinded trial of 734 high-risk patients aged 50 years or older undergoing major gastrointestinal surgery at 17 acute care hospitals in the United Kingdom .
METHODS	An updated systematic review and meta-analysis were also conducted including randomized trials published from 1966 to February 2014 .
METHODS	Patients were randomly assigned to a cardiac output-guided hemodynamic therapy algorithm for intravenous fluid and inotrope ( dopexamine ) infusion during and 6 hours following surgery ( n = 368 ) or to usual care ( n = 366 ) .
METHODS	The primary outcome was a composite of predefined 30-day moderate or major complications and mortality .
METHODS	Secondary outcomes were morbidity on day 7 ; infection , critical care-free days , and all-cause mortality at 30 days ; all-cause mortality at 180 days ; and length of hospital stay .
RESULTS	Baseline patient characteristics , clinical care , and volumes of intravenous fluid were similar between groups .
RESULTS	Care was nonadherent to the allocated treatment for less than 10 % of patients in each group .
RESULTS	The primary outcome occurred in 36.6 % of intervention and 43.4 % of usual care participants ( relative risk [ RR ] , 0.84 [ 95 % CI , 0.71-1 .01 ] ; absolute risk reduction , 6.8 % [ 95 % CI , -0.3 % to 13.9 % ] ; P = .07 ) .
RESULTS	There was no significant difference between groups for any secondary outcomes .
RESULTS	Five intervention patients ( 1.4 % ) experienced cardiovascular serious adverse events within 24 hours compared with none in the usual care group .
RESULTS	Findings of the meta-analysis of 38 trials , including data from this study , suggest that the intervention is associated with fewer complications ( intervention , 488/1548 [ 31.5 % ] vs control , 614/1476 [ 41.6 % ] ; RR , 0.77 [ 95 % CI , 0.71-0 .83 ] ) and a nonsignificant reduction in hospital , 28-day , or 30-day mortality ( intervention , 159/3215 deaths [ 4.9 % ] vs control , 206/3160 deaths [ 6.5 % ] ; RR , 0.82 [ 95 % CI , 0.67-1 .01 ] ) and mortality at longest follow-up ( intervention , 267/3215 deaths [ 8.3 % ] vs control , 327/3160 deaths [ 10.3 % ] ; RR , 0.86 [ 95 % CI , 0.74-1 .00 ] ) .
CONCLUSIONS	In a randomized trial of high-risk patients undergoing major gastrointestinal surgery , use of a cardiac output-guided hemodynamic therapy algorithm compared with usual care did not reduce a composite outcome of complications and 30-day mortality .
CONCLUSIONS	However , inclusion of these data in an updated meta-analysis indicates that the intervention was associated with a reduction in complication rates .
BACKGROUND	isrctn.org Identifier : ISRCTN04386758 .

###24296904
OBJECTIVE	The Nurse-Family Partnership delivered by nurses has been found to produce long-term effects on maternal and child health in replicated randomized trials .
OBJECTIVE	A persistent question is whether paraprofessional home visitors might produce comparable effects .
OBJECTIVE	To examine the impact of prenatal and infancy/toddler home visits by paraprofessionals and by nurses on child development at child ages 6 and 9 years .
METHODS	Randomized trial in public and private care settings in Denver , Colorado , of 735 low-income women and their first-born children ( 85 % of the mothers were unmarried ; 47 % were Hispanic , 35 % were non-Hispanic white , 15 % were African American , and 3 % were American Indian/Asian ) .
METHODS	Home visits provided from pregnancy through child age 2 years delivered in one group by paraprofessionals and in the other by nurses .
METHODS	Reports of children 's internalizing , externalizing , and total emotional/behavioral problems , and tests of children 's language , intelligence , attention , attention dysfunction , visual attention/task switching , working memory , and academic achievement .
METHODS	We hypothesized that program effects on cognitive-related outcomes would be more pronounced among children born to mothers with low psychological resources .
METHODS	We report paraprofessional-control and nurse-control differences with P < .10 given similar effects in a previous trial , earlier effects in this trial , and limited statistical power .
RESULTS	There were no significant paraprofessional effects on emotional/behavioral problems , but paraprofessional-visited children born to mothers with low psychological resources compared with control group counterparts exhibited fewer errors in visual attention/task switching at age 9 years ( effect size = -0.30 , P = .08 ) .
RESULTS	There were no statistically significant paraprofessional effects on other primary outcomes .
RESULTS	Nurse-visited children were less likely to be classified as having total emotional/behavioral problems at age 6 years ( relative risk [ RR ] = 0.45 , P = .08 ) , internalizing problems at age 9 years ( RR = 0.44 , P = .08 ) , and dysfunctional attention at age 9 years ( RR = 0.34 , P = .07 ) .
RESULTS	Nurse-visited children born to low-resource mothers compared with control-group counterparts had better receptive language averaged over ages 2 , 4 , and 6 years ( effect size = 0.30 , P = .01 ) and sustained attention averaged over ages 4 , 6 , and 9 years ( effect size = 0.36 , P = .006 ) .
RESULTS	There were no significant nurse effects on externalizing problems , intellectual functioning , and academic achievement .
CONCLUSIONS	Children born to low-resource mothers visited by paraprofessionals exhibited improvement in visual attention/task switching .
CONCLUSIONS	Nurse-visited children showed improved behavioral functioning , and those born to low-resource mothers benefited in language and attention but did not improve in intellectual functioning and academic achievement .
BACKGROUND	clinicaltrials.gov Identifier : NCT00438282 and NCT00438594 .

###24299501
BACKGROUND	Inhaler mishandling is a common issue among patients suffering from asthma and is associated with poor clinical outcomes and greater consumption of health-care resources .
BACKGROUND	Ease of use can improve inhaler technique and , possibly , patients ' preference for their inhaler device , which in turn may lead to better adherence to therapy .
METHODS	This study investigated usability characteristics of NEXThaler ( ) versus two other dry powder inhalers ( DPIs ; Diskus ( ) and Turbuhaler ( ) ) .
METHODS	Sixty-six adult patients with asthma ( mean age 42.917.7 years ) and with no previous experience of using a DPI were included in a randomized crossover comparison of the three devices .
METHODS	The main measures of usability were the number of steps failed for each device and the number of people who were able to use the device successfully ( effectiveness ) , the time it took patients to set up the device and the time to read the instructions for use ( IFU ; efficiency ) , and patient preferences ( satisfaction ) .
METHODS	Inhaler technique was evaluated after the IFU leaflet was read .
RESULTS	NEXThaler was found to be superior to the other two DPIs in terms of the number of device use failures ( p < 0.001 ) , time to set up ( p < 0.001 ) , and time to read IFU ( p < 0.001 ) .
RESULTS	Additionally , the proportion of participants who completed a successful inhalation without any errors at all was significantly higher for NEXThaler than for Diskus and Turbuhaler ( p < 0.001 ) .
RESULTS	Patients rated NEXThaler as the easiest to use and most preferred inhaler to own ( p < 0.001 ) .
CONCLUSIONS	NEXThaler displayed better usability compared with Diskus and Turbuhaler .
CONCLUSIONS	The improved usability and higher satisfaction with the device may contribute to increased patient adherence to asthma treatment .

###24819083
BACKGROUND	Randomized data support shorter radiotherapy courses for management of cancer-related symptoms in the palliative setting .
OBJECTIVE	The purpose of this study was to evaluate the length of palliative radiotherapy before hospice enrollment among the elderly U.S. population , with a further focus on factors that influence the duration of radiation and the length of survival on hospice , including whether the duration of radiation was associated with length of survival on hospice .
METHODS	A total of 6982 patients with breast , prostate , lung , or colorectal cancer who received a course of radiotherapy within 30days before hospice enrollment were identified within the Surveillance , Epidemiology , and End Results-Medicare linked database .
METHODS	The primary end points included the duration of palliative radiotherapy and the time from hospice enrollment through death ( hospice duration ) .
METHODS	Multivariate linear regression and multivariate Cox models evaluated factors associated with the length of radiotherapy course and hospice duration .
RESULTS	The median length of palliative radiotherapy was 14days , and the median hospice duration was 13days .
RESULTS	The course of palliative radiotherapy was longer than hospice duration in 48 % of the patients .
RESULTS	Breast and lung cancer were associated with longer courses of radiotherapy and shorter stays on hospice .
RESULTS	Patients treated in freestanding radiation centers had longer courses of radiotherapy .
RESULTS	For these groups , a longer radiotherapy course was not associated with longer hospice duration .
CONCLUSIONS	This study found relatively long courses of radiotherapy before short lengths of survival on hospice .
CONCLUSIONS	Future research is needed to identify barriers to shorter radiotherapy courses .

###24947287
OBJECTIVE	The once-daily oral factor Xa inhibitor , edoxaban , is as effective as warfarin in preventing stroke and systemic embolism while decreasing bleeding in a phase III trial of patients with atrial fibrillation at moderate-high stroke risk .
OBJECTIVE	Limited data regarding cerebrovascular events with edoxaban were reported previously .
METHODS	We analyzed the subtypes of cerebrovascular events in 21 105 patients participating in Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48 ( ENGAGE AF-TIMI 48 ) comparing outcomes among patients randomized to warfarin versus 2 edoxaban regimens ( high dose , low dose ) .
METHODS	The primary end point for this prespecified analysis of cerebrovascular events was all stroke ( ischemic plus hemorrhagic ) , defined as an abrupt onset of focal neurological deficit because of infarction or bleeding with symptoms lasting 24 hours or fatal in < 24 hours .
METHODS	Independent stroke neurologists unaware of treatment adjudicated all cerebrovascular events .
RESULTS	Patients randomized to high-dose edoxaban had fewer strokes on-treatment ( hazard ratio , 0.80 ; 95 % confidence interval , 0.65-0 .98 ) than warfarin ( median time-in-therapeutic range , 68.4 % ) ; patients in the low-dose edoxaban group had similar rates ( hazard ratio , 1.10 versus warfarin ; 95 % confidence interval , 0.91-1 .32 ) .
RESULTS	Rates of ischemic stroke or transient ischemic attack were similar with high-dose edoxaban ( 1.76 % per year ) and warfarin ( 1.73 % per year ; P = 0.81 ) , but more frequent with low-dose edoxaban ( 2.48 % per year ; P < 0.001 ) .
RESULTS	Both edoxaban regimens significantly reduced hemorrhagic stroke and other subtypes of intracranial bleeds .
CONCLUSIONS	In patients with atrial fibrillation , once-daily edoxaban was as effective as warfarin in preventing all strokes , with significant reductions in various subtypes of intracranial bleeding .
CONCLUSIONS	Ischemic cerebrovascular event rates were similar with high-dose edoxaban and warfarin , whereas low-dose edoxaban was less effective than warfarin .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00781391 .

###25928214
BACKGROUND	The aim of our study was to evaluate the clinical impact of the administration of intravenous steroids , alone or in conjunction with drotrecogin-alfa ( activated ) ( DrotAA ) , on the outcomes in septic shock patients .
METHODS	We performed a sub-study of the PROWESS-Shock trial ( septic shock patients who received fluids and vasopressors above a predefined threshold for at least 4 hours were randomized to receive either DrotAA or placebo for 96 hours ) .
METHODS	A propensity score for the administration of intravenous steroids for septic shock at baseline was constructed using multivariable logistic regression .
METHODS	Cox proportional hazards model using inverse probability of treatment weighting of the propensity score was used to estimate the effect of intravenous steroids , alone or in conjunction with DrotAA , on 28-day and 90-day all-cause mortality .
RESULTS	A total of 1695 patients were enrolled of which 49.5 % received intravenous steroids for treatment of septic shock at baseline ( DrotAA + steroids N = 436 ; DrotAA + no steroids N = 414 ; placebo + steroids N = 403 ; placebo + no steroids N = 442 ) .
RESULTS	The propensity weighted risk of 28-day as well as 90-day mortality in those treated vs. those not treated with steroids did not differ among those randomized to DrotAA vs. placebo ( interaction p-value = 0.38 and p = 0.27 , respectively ) nor was a difference detected within each randomized treatment .
RESULTS	Similarly , the course of vasopressor use and cardiovascular SOFA did not appear to be influenced by steroid therapy .
RESULTS	In patients with lung infection ( N = 744 ) , abdominal infection ( N = 510 ) , Gram-positive sepsis ( N = 420 ) and Gram-negative sepsis ( N = 461 ) , the propensity weighted risk of 28-day as well as 90-day mortality in those treated vs. those not treated with steroids did not differ among those randomized to DrotAA vs. placebo nor was a difference detected within each randomized treatment .
CONCLUSIONS	In the present study of septic shock patients , after adjustment for treatment selection bias , we were unable to find noticeable positive impact from intravenous steroids for treatment of septic shock at baseline either in patients randomized for DrotAA or placebo .
BACKGROUND	Clinicaltrials.gov NCT00604214 .
BACKGROUND	Registered 24 January 2008 .

###24861389
BACKGROUND	Fibrin sealant ( FS ) is a biologically derived tissue adhesive for securing flaps .
BACKGROUND	The aim of the present randomized controlled clinical trial was to compare early wound healing by assessing interleukin-1 ( IL-1 ) and interleukin-8 ( IL-8 ) levels from gingival crevicular fluid ( GCF ) after using FS and suture for periodontal flap closure .
METHODS	Thirty selected quadrants in 15 periodontitis patients were randomly assigned to either a test ( fibrining ) or control group ( suturing ) for flap closure .
METHODS	IL-1 and IL-8 were assessed in GCF using enzyme-linked immunosorbent assay ( ELISA ) before and eight days after surgery .
METHODS	Patients were recalled at 7 , 14 , 21days and 3months after surgery for clinical assessment .
RESULTS	There was a statistically significant decrease in IL-1 ( 84.8277.18 , 29.221.97 pg/l ) and IL-8 ( 57.9455.47 , 21.8221.93 pg/l ) levels in the test side after fibrining while there was an increase in the control side ( IL-1 31.4016.82 , 128.845.14 ; IL-8 31.4016.82 , 128.8345.14 pg/l ) ( p < 0.05 ) .
RESULTS	The change in concentration of IL-1 and IL-8 following intervention correlated significantly in both the sites .
RESULTS	Clinical parameters differed significantly only on the seventh day with less plaque and bleeding on the test sites .
CONCLUSIONS	Fibrin sealant enhances early wound healing by reducing inflammation after periodontal flap surgery .

###24390828
BACKGROUND	Continuous lumbar plexus block ( LPB ) is a well-accepted technique for regional analgesia after THA .
BACKGROUND	However , many patients experience considerable quadriceps motor weakness with this technique , thus impairing their ability to achieve their physical therapy goals .
OBJECTIVE	We asked whether L2 paravertebral block ( PVB ) provides better postoperative analgesia ( defined as decreased postoperative opioid consumption and lower pain scores ) , better preservation of motor function , and decreased length of hospital stay ( LOS ) compared to LPB in patients undergoing THA .
METHODS	Sixty patients undergoing minimally invasive THA under standardized spinal anesthesia were enrolled in this randomized controlled study .
METHODS	After exclusions , 53 patients were randomized into the L2 PVB ( n = 27 ) and LPB ( n = 26 ) groups .
METHODS	Patient-controlled analgesia was available for 24 hours .
METHODS	Motor and pain assessments were performed in the recovery room and at the end of 24 hours .
METHODS	LOS was also noted .
RESULTS	Postoperative opioid consumption during the first 24 hours was less in the LPB group ( mean SD : 24 15 mg morphine ) than in the L2 PVB group ( 32 15 mg morphine ; p = 0.005 ) ; however , postoperative pain scores were not different between groups .
RESULTS	Postoperative motor and rehabilitation outcomes and LOS were also similar .
CONCLUSIONS	Our study demonstrates that use of a LPB results in slightly less morphine consumption but comparable pain scores when compared with continuous L2 PVB .
CONCLUSIONS	No difference was noted in terms of motor preservation or LOS .
CONCLUSIONS	Although the difference in morphine consumption was only slightly in favor of the LPB group , the advantage of L2 PVBs noted by previous authors as preservation of motor function , was not seen .
CONCLUSIONS	At our institute where LPBs have been performed for years , there seems to be no real advantage in switching to L2 PVBs .
CONCLUSIONS	However , L2 PVB could be a reasonable alternative for operators who are wary of LPBs due to their high potential for complications and/or requiring advanced skills for its placement .
CONCLUSIONS	But , since L2 PVBs are relatively new , not much is known about their complication profile .
CONCLUSIONS	We recommend a thorough understanding of both techniques before attempting to place them .
METHODS	Level I , therapeutic study .
METHODS	See Instructions for Authors for a complete description of levels of evidence .

###24499061
BACKGROUND	Annually approximately 100.000 patients undergo a laparotomy in the Netherlands .
BACKGROUND	About 15,000 of these patients will develop an incisional hernia .
BACKGROUND	Both open and laparoscopic surgical repair have been proven to be safe .
BACKGROUND	However , the most effective treatment of incisional hernias remains unclear .
BACKGROUND	This study , the ` INCH-trial ' , comparing cost-effectiveness of open and laparoscopic incisional hernia repair , is therefore needed .
METHODS	A randomized multi-center clinical trial comparing cost-effectiveness of open and laparoscopic repair of incisional hernias .
METHODS	Patients with a symptomatic incisional hernia , eligible for laparoscopic and open incisional hernia repair .
METHODS	Only surgeons , experienced in both open and laparoscopic incisional hernia repair , will participate in the INCH trial .
METHODS	During incisional hernia repair , a mesh is placed under or on top of the fascia , with a minimal overlap of 5 cm .
METHODS	Primary endpoint is length of hospital stay after an incisional hernia repair .
METHODS	Secondary endpoints are time to full recovery within three months after index surgery , post-operative complications , recurrences , mortality and quality of life.Our hypothesis is that laparoscopic incisional hernia repair comes with a significant shorter hospital stay compared to open incisional hernia repair .
METHODS	A difference of two days is considered significant .
METHODS	One-hunderd-and-thirty-five patients are enrolled in each treatment arm .
METHODS	The economic evaluation will be performed from a societal perspective .
METHODS	Primary outcomes are costs per patient related to time-to-recovery and quality of life.The main goal of the trial is to establish whether laparoscopic incisional hernia repair is superior to conventional open incisional hernia repair in terms of cost-effectiveness .
METHODS	This is measured through length of hospital stay and quality of life .
METHODS	Secondary endpoints are re-operation rate due to post-operative complications or recurrences , mortality and quality of life .
CONCLUSIONS	The difference in time to full recovery between the two treatment strategies is thought to be in favor of laparoscopic incisional hernia repair .
CONCLUSIONS	Laparoscopic incisional hernia repair is therefore expected to be a more cost-effective approach .
BACKGROUND	Netherlands Trial register : NTR2808 .

###25390455
BACKGROUND	Oxygen consumption may be impaired in critically ill patients .
OBJECTIVE	To evaluate the effect of intravenous thiamine on oxygen consumption ( [ Formula : see text ] o2 ) in critically ill patients .
METHODS	This was a small , exploratory open-label pilot study conducted in the intensive care units at a tertiary care medical center .
METHODS	Critically ill adults requiring mechanical ventilation were screened for enrollment .
METHODS	Oxygen consumption ( [ Formula : see text ] o2 ) and cardiac index ( CI ) were recorded continuously for 9 hours .
METHODS	After 3 hours of baseline data collection , 200 mg of intravenous thiamine was administered .
METHODS	The outcome was change in [ Formula : see text ] o2 after thiamine administration .
RESULTS	Twenty patients were enrolled and 3 were excluded because of incomplete [ Formula : see text ] o2 data , leaving 17 patients for analysis .
RESULTS	There was a trend toward increase in [ Formula : see text ] o2 after thiamine administration ( 16.3 ml/min , SE 8.5 ; P = 0.052 ) .
RESULTS	After preplanned adjustment for changes in CI in case of a delivery-dependent state in some patients ( with exclusion of one additional patient because of missing CI data ) , this became statistically significant ( 16.9 ml/min , SE 8.6 ; P = 0.047 ) .
RESULTS	In patients with average CI greater than our cohort 's mean value of 3 L/min/m ( 2 ) , [ Formula : see text ] o2 increased by 70.9 ml/min ( 16 ; P < 0.0001 ) after thiamine .
RESULTS	Thiamine had no effect in patients with reduced CI ( < 2.4 L/min/m ( 2 ) ) .
RESULTS	There was no association between initial thiamine level and change in [ Formula : see text ] o2 after thiamine administration .
CONCLUSIONS	The administration of a single dose of thiamine was associated with a trend toward increase in [ Formula : see text ] o2 in critically ill patients .
CONCLUSIONS	There was a significant increase in [ Formula : see text ] o2 in those patients with preserved or elevated CI .
CONCLUSIONS	Further study is needed to better characterize the role of thiamine in oxygen extraction .
CONCLUSIONS	Clinical trial registered with www.clinicaltrials.gov ( NCT01462279 ) .

###25192562
OBJECTIVE	To assess the efficacy of aromatic essential oils on neck pain .
METHODS	Sixty participants with a history of neck pain and Neck Disability Index ( NDI ) score > 10 % were selected and randomly divided into control and experimental groups .
METHODS	Motion analysis laboratory at Hungkuang University .
METHODS	For the experimental group , the intervention included 3 % concentration cream composed of four essential oils : marjoram , black pepper , lavender , and peppermint .
METHODS	For the control group , only an unscented cream was provided .
METHODS	For 4 weeks , all patients applied 2g cream directly to the affected area daily after showering or bathing .
METHODS	Assessment was performed by using a visual analogue scale ( VAS ) , NDI , pressure pain threshold ( PPT ) evaluated with a pressure meter , and neck-joint range evaluated with Motion Analysis System ( MAS ) .
RESULTS	A t-test statistical analysis by SPSS statistical software indicated that VAS scores improved significantly for both groups ( p < 0.05 ) .
RESULTS	In addition , the experimental group had improved pain tolerance in the left upper trapezius ( meanstandard deviation , 2.962.54 ) and right upper trapezius ( 2.882.90 ) as measured by the PPT .
RESULTS	According to the NDI , the experimental group also showed significant improvement ( p = 0.02 ) .
RESULTS	Comparison of MAS values before and after the intervention showed significant improvement in the 10 motion areas in the experimental group .
RESULTS	This finding suggests that the experimental group had better results than the control group .
CONCLUSIONS	The essential oil cream developed in this study can be used to improve neck pain .
CONCLUSIONS	This study appears to be the first to quantify this by using PPT and MAS .

###25377349
BACKGROUND	Few studies have evaluated interventions to improve quality of life ( QOL ) for Latina breast cancer survivors and caregivers .
BACKGROUND	Following best practices in community-based participatory research ( CBPR ) , we established a multi-level partnership among Latina survivors , caregivers , community-based organizations ( CBOs ) , clinicians , and researchers to evaluate a survivor-caregiver QOL intervention .
METHODS	A CBO in the mid-Atlantic region , Nueva Vida , developed a patient-caregiver program called Cuidando a mis Cuidadores ( Caring for My Caregivers ) , to improve outcomes important to Latina cancer survivors and their families .
METHODS	Together with an academic partner , Nueva Vida and three CBOs established a multi-level team of researchers , clinicians , Latina cancer survivors , and caregivers to conduct a national randomized trial to compare the patient-caregiver program to usual care .
RESULTS	Incorporating team feedback and programmatic considerations , we adapted the prior patient-caregiver program into an 8-session patient - and caregiver-centered intervention that includes skill-building workshops such as managing stress , communication , self-care , social well-being , and impact of cancer on sexual intimacy .
RESULTS	We will measure QOL domains with the patient-reported outcomes measurement information system , dyadic communication between the survivor and caregiver , and survivors ' adherence to recommended cancer care .
RESULTS	To integrate the intervention within each CBO , we conducted interactive training on the protection of human subjects , qualitative interviewing , and intervention delivery .
CONCLUSIONS	The development and engagement process for our QOL intervention study is innovative because it is both informed by and directly impacts underserved Latina survivors and caregivers .
CONCLUSIONS	The CBPR-based process demonstrates successful multi-level patient engagement through collaboration among researchers , clinicians , community partners , survivors , and caregivers .

###24443876
OBJECTIVE	This study evaluated change in health-related quality of life ( HRQOL ) associated with ongoing weight change among patients with type 2 diabetes mellitus ( T2DM ) treated with dapagliflozin , a highly selective sodium-glucose cotransporter 2 ( SGLT2 ) inhibitor that lowers blood glucose by increasing urinary glucose excretion and is associated with body weight reductions .
METHODS	Patients with T2DM who had inadequate glycaemic control on metformin ( MET ) alone were enrolled in a 24-week , double-blind , randomized , placebo-controlled study with a 78-week extension to evaluate the effect of dapagliflozin + MET on body weight .
METHODS	Patients also completed the Study to Help Improve Early evaluation and management of risk factors Leading to Diabetes Weight Questionnaire-9 ( SHIELD-WQ-9 ) , a weight change-related HRQOL survey .
METHODS	Difference in proportions of patients treated with dapagliflozin 10mg + MET ( n = 89 ) or placebo + MET ( n = 91 ) who reported improvement in HRQOL was analysed with Fisher 's exact test .
RESULTS	Dapagliflozin patients had significantly greater weight loss than placebo patients over 102weeks ( p < 0.05 ) .
RESULTS	This corresponded to a numerically greater proportion of dapagliflozin-treated patients reporting ongoing weight loss and associated improvements in most HRQOL domains at three different evaluation points ( weeks 24 , 50 and 102 ) than placebo-treated patients .
RESULTS	In a post-hoc analysis among patients who reported ongoing weight loss regardless of treatment arm , a significantly greater proportion of patients reporting weight loss versus weight gain reported improvements in physical health , self-esteem and overall HRQOL at weeks 24 , 50 and 102 .
CONCLUSIONS	Dapagliflozin-induced weight loss was associated with improvement in overall HRQOL .
CONCLUSIONS	Overall , ongoing weight loss was associated with improvements in several HRQOL domains compared with weight gain .

###24521487
OBJECTIVE	Care services for older people are provided with the expectation of supporting carers in their caregiving role .
OBJECTIVE	The aim of the study is to investigate the association between the utilisation of care services by older people and the caregiving experience .
METHODS	Cross-sectional design , involving a cohort of family carers ( n = 119 ) of frail older people ( 70 years ) enrolled in a clinical trial of frailty treatment in metropolitan Sydney from 2008 to 2011 .
METHODS	The caregiving experience was measured in five domains : health , daily schedule , finance , family support and self-esteem ( Caregiver Reaction Assessment tool ) .
RESULTS	Multivariate regression analysis demonstrated an association between the utilisation of residential respite care and financial strain ( = -0.613 , P = 0.049 ) , after controlling for functional ability , co-residence and age .
CONCLUSIONS	There is a need to consider carers ' financial barriers and concerns in regards to the utilisation of respite care services .

###24735200
OBJECTIVE	We examine improvement and worsening in quality of life ( QOL ) in terms of proportions achieving minimum clinically important change ( MCID ) , and factors related to MCID , in patients with temporal lobe epilepsy randomized to medical or surgical treatment .
METHODS	Eighty patients with temporal lobe epilepsy randomized to surgical ( n ( 1 ) = 40 ) or medical ( n ( 2 ) = 40 ) therapy were followed for 12 months , reporting QOL at baseline , and at 6 and 12 months .
METHODS	Previously established thresholds for MCID across various general and epilepsy-specific QOL instruments were used to determine meaningful improvement ( positive MCID ) or worsening ( negative MCID ) .
METHODS	Generalized linear mixed-effects models were used to compare MCID in both groups .
RESULTS	At 6 months , 56.0 % of patients in the surgical group achieved positive MCID on the Quality of Life in Epilepsy ( QOLIE ) -89 , as compared to 11.0 % of those in the medical group ( p < 0.001 ) .
RESULTS	On the QOLIE-31 , 62.0 % of the surgical group and 17.0 % of the medical group achieved positive MCID ( p < 0.001 ) .
RESULTS	Substantially more medically treated patients exhibited clinically significant worsening in QOL , as compared with those surgically treated .
RESULTS	The respective medical versus surgical proportions with worsening were 36.67 % versus 13.8 % in QOLIE31 , 20 % versus 15 % in Health Utility Index-III ( HUI-III ) , and 30 % versus 19 % in Short Form-36 ( SF-36 ) Mental Composite Score ( MCS ) .
RESULTS	The number of patients who need to undergo surgery for one additional person to have a meaningful improvement in the QOLIE-31 is two ( number needed to treat = 2 ) .
RESULTS	The results also favored surgery using the generic HUI-III instrument , but not with the mental of physical function subscales of the SF-36 .
CONCLUSIONS	Significantly more patients in the surgical group achieved meaningful improvement in epilepsy-specific measures of QOL at 6 and 12 months compared to those in the medical group .
CONCLUSIONS	Substantially more patients in the medical therapy group exhibited clinically significant worsening in their QOL assessed with epilepsy-specific and generic instruments .
CONCLUSIONS	A PowerPoint slide summarizing this article is available for download in the Supporting Information section here .

###24564877
BACKGROUND	To evaluate feasibility and potential effectiveness of a patient decision aid ( PtDA ) for patients and a preference report for surgeons to reduce wait times and improve decision quality in patients with osteoarthritis considering total knee replacement .
METHODS	A prospective two-arm pilot randomized controlled trial .
METHODS	Patients with osteoarthritis were eligible if they understood English and were referred for surgical consultation about an initial total knee arthroplasty at a Canadian orthopaedic joint assessment clinic .
METHODS	Patients were randomized to the PtDA intervention or usual education .
METHODS	The intervention was an osteoarthritis PtDA for patients and a one-page preference report summarizing patients ' clinical and decisional data for their surgeon .
METHODS	The main feasibility outcomes were rates of recruitment and questionnaire completion ; the preliminary effectiveness outcomes were wait times and decision quality .
RESULTS	Of 180 patients eligible for surgical consultation , 142 ( 79 % ) were recruited and randomized to the PtDA intervention ( n = 71 ) or usual education ( n = 71 ) .
RESULTS	Data collection yielded a 93 % questionnaire completion rate with less than 1 % missing items .
RESULTS	After one year , 13 % of patients remained on the surgical wait list .
RESULTS	The median time from referral to being off the wait list ( censored using survival analysis techniques ) was 33.4 weeks for the PtDA group ( n = 69 , 95 % CI : 26.0 , 41.4 ) and 33.0 weeks for usual education ( n = 71 , 95 % CI : 26.1 , 39.9 ) .
RESULTS	Patients exposed to the PtDA had higher decision quality based on knowledge ( 71 % versus 47 % ; p < 0.0001 ) and quality decision being an informed choice that is consistent with their values for option outcomes ( 56.4 % versus 25.0 % ; p < 0.001 ) .
CONCLUSIONS	Recruitment of patients with osteoarthritis considering surgery and data collection were feasible .
CONCLUSIONS	As some patients remained on the surgical waiting list after one year , follow-up should be extended to two years .
CONCLUSIONS	Patients exposed to the PtDA achieved higher decision quality compared to those receiving usual education but there was no difference in wait for surgery .
BACKGROUND	ClinicalTrials.Gov NCT00743951 .

###25695576
BACKGROUND	While surgery and perioperative smoking cessation interventions may motivate patients to quit smoking in the short term , it is unknown how often this translates into permanent cessation .
BACKGROUND	In this study , we sought to determine the rates of long-term smoking cessation after a perioperative smoking cessation intervention and predictors of successful cessation at 1 year .
METHODS	We previously reported short-term results from a perioperative randomized controlled trial comparing usual care with an intervention involving ( 1 ) brief counseling by the preadmission nurse , ( 2 ) smoking cessation brochures , ( 3 ) referral to a telephone quitline , and ( 4 ) a free 6-week supply of transdermal nicotine replacement .
METHODS	We now report our 1-year follow-up outcomes .
RESULTS	Between October 2010 and April 2012 , 168 patients were randomized .
RESULTS	At 1 year , 127 patients ( 76 % ) were available for follow-up telephone interview .
RESULTS	Smoking cessation occurred in 8 % of control patients compared with 25 % of patients in the intervention group ( relative risk , 3.0 ; 95 % confidence interval [ CI ] , 1.2-7 .8 ; P = 0.018 ) .
RESULTS	The number needed-to-treat to achieve smoking cessation for 1 patient at 1 year postoperatively was 5.9 ( 95 % CI , 3.4-25 .9 ) .
RESULTS	Multivariable logistic regression modeling found that the intervention ( P = 0.020 ) and lower nicotine dependency at baseline ( P < 0.001 ) were predictive of success at smoking cessation at 1 year .
RESULTS	Poisson regression showed that adjusted for nicotine dependency , those randomized to the intervention group were 2.7 times ( 95 % CI , 1.1-6 .7 ; P = 0.028 ) more likely to achieve long-term cessation than those in the control group .
RESULTS	Adjusted for randomization group , a low level of nicotine dependency resulted in a relative risk of quitting of 5.1 ( 95 % CI , 2.0-12 .8 ; P = 0.001 ) .
CONCLUSIONS	This study demonstrates that an intervention designed for a busy preadmission clinic results in decreased smoking rates not only around the time of surgery but also continued benefit in smoking cessation at 1 year .
CONCLUSIONS	Perioperative care providers have a unique opportunity to assist patients in smoking cessation and achieve long-lasting results .

###24505271
OBJECTIVE	The aim of this study was to investigate whether more sickness absence is reported in countries with higher income inequality than elsewhere , and whether the level of income inequality moderates the association between psycho-social job demands and sickness absence .
METHODS	Our analysis is based on the Fifth European Working Conditions Survey that compared 23 European countries .
METHODS	We performed multi-level regression analysis .
METHODS	On the macro-level of analysis we included the Gini-Index as measure of inequality .
METHODS	On the micro-level of analysis we followed the Karasek-Theorell model and included three scales for psychological job demands , physical job demands , and decision latitude in the model .
METHODS	The model was stratified by sex .
RESULTS	We found that , in countries with high income inequality , workers report significantly more sickness absence than workers in countries with low income inequality .
RESULTS	In addition we found that the level of income inequality moderates the relationship between psychological job demands and sickness absence .
RESULTS	High psychological job demands are significantly more strongly related to more days of sickness absence in countries with low income inequality than in countries with high income inequality .
CONCLUSIONS	As the nature and causal pathways of cross-level interaction effects still can not be fully explained , we argue that future research should aim to explore such causal pathways .
CONCLUSIONS	In accordance with WHO recommendations we argue that inequalities should be reduced .
CONCLUSIONS	In addition we state that , particularly in countries with low levels of income inequality , policies should aim to reduce psychological job demands .

###24332423
OBJECTIVE	This study sought to assess the 2-year outcomes of the population included in the EXAMINATION ( Everolimus-Eluting Stents Versus Bare-Metal Stents in ST-Segment Elevation Myocardial Infarction ) trial beyond the 1-year prescription period of dual antiplatelet therapy .
BACKGROUND	The EXAMINATION trial compared the performance of everolimus-eluting stents ( EES ) versus bare-metal stents ( BMS ) in an all-comer ST-segment elevation myocardial infarction ( STEMI ) population .
METHODS	This was a multicenter , multinational , prospective , randomized , single-blind , controlled trial in patients with STEMI .
METHODS	The primary endpoint , which was the combined endpoint of all-cause death , any recurrent myocardial infarction , and any revascularization , and the endpoints target lesion revascularization and stent thrombosis were assessed at 2 years .
RESULTS	Between December 31 , 2008 , and May 15 , 2010 , 1,498 patients were randomized to receive EES ( n = 751 ) or BMS ( n = 747 ) .
RESULTS	Compliance with dual antiplatelet regimen was reduced at 2 years to a similar degree ( 17.3 % vs. 17.2 % , p = 0.91 ) .
RESULTS	At 2 years , the primary endpoint occurred in 108 ( 14.4 % ) patients of the EES group and in 129 ( 17.3 % ) patients of the BMS group ( p = 0.11 ) .
RESULTS	Rate of target lesion revascularization was significantly lower in the EES group than in the BMS group ( 2.9 % vs. 5.6 % ; p = 0.009 ) .
RESULTS	Rates of definite and definite or probable stent thrombosis were also significantly reduced in the EES group ( 0.8 % vs. 2.1 % ; p = 0.03 , and 1.3 % vs. 2.8 % ; p = 0.04 , respectively ) .
CONCLUSIONS	The 2-year follow-up of the EXAMINATION trial confirms the safety and efficacy of the EES compared with BMS in the setting of STEMI .
CONCLUSIONS	Specifically , both rates of target lesion revascularization and stent thrombosis were reduced in recipients of EES without any signs of late attrition for either of these endpoints .
CONCLUSIONS	( A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction : EXAMINATION Study ; NCT00828087 ) .

###25240454
OBJECTIVE	The purpose of this study was to evaluate prevalence , progression , treatment , and outcome of silent coronary artery disease ( CAD ) in asymptomatic patients with diabetes ( DM ) at high coronary risk .
BACKGROUND	Despite the close association of diabetes and CAD , general CAD screening in asymptomatic patients with DM is discouraged even though outcome data in patients at high coronary risk are lacking .
METHODS	Prospective multicenter outcome study-with a pilot randomized treatment substudy .
METHODS	The study comprised 400 asymptomatic patients with DM ( type 2 ) without history or symptoms of CAD at high CAD risk .
METHODS	They underwent clinical evaluation and myocardial perfusion single-photon emission computed tomography ( MPS ) at baseline and after 2 years .
METHODS	Patients with normal MPS received usual care ; those with abnormal MPS received medical or combined invasive and medical management .
RESULTS	An abnormal MPS was found in 87 of 400 patients ( 22 % ) .
RESULTS	In patients with normal MPS , MACE occurred in 2.9 % and ischemia or new scar in 3.2 % .
RESULTS	Patients with abnormal MPS had more MACE ( 9.8 % ; hazard ratio : 3.44 ; 95 % confidence interval [ CI ] : 1.32 to 8.95 ; p = 0.011 ) and ischemia or new scar ( 34.2 % ; odds ratio : 15.91 ; 95 % CI : 7.24 to 38.03 ; p < 0.001 ) despite therapy , resulting in `` overt or silent CAD progression '' of 35.6 % versus 4.6 % ( odds ratio : 11.53 ; 95 % CI : 5.63 to 24.70 ; p < 0.001 ) .
RESULTS	Patients with abnormal MPS randomized to medical versus invasive-medical strategies had similar event rates ( p = 0.215 ) , but more ischemic or new scar findings ( 54.3 % vs. 15.8 % ; p < 0.001 ) .
CONCLUSIONS	High-risk asymptomatic patients with DM and normal MPS ( 78 % ) have a low rate of first manifestations of CAD .
CONCLUSIONS	Patients with abnormal MPS at baseline ( 22 % ) have a 7-fold higher rate of progression to `` overt or silent CAD , '' despite therapy .
CONCLUSIONS	Randomized patients ' outcomes suggest that a combined invasive and medical strategy for silent CAD may reduce scintigraphic but not symptomatic CAD progression versus medical therapy alone .
CONCLUSIONS	( Trial of Invasive versus Medical therapy of Early coronary artery disease in Diabetes Mellitus ISRCTN87953632 ) .

###25208464
BACKGROUND	Chronic obstructive pulmonary disease ( COPD ) is associated with eosinophilic airway inflammation in 10-20 % of patients .
BACKGROUND	Benralizumab , an anti-interleukin-5 receptor monoclonal antibody , depletes blood and sputum eosinophils .
BACKGROUND	We aimed to establish whether benralizumab reduces acute exacerbations of COPD in patients with eosinophilia and COPD .
METHODS	We did this randomised , double-blind , placebo-controlled , phase 2a study between Nov 18 , 2010 , and July 13 , 2013 , at 26 sites in the UK , Poland , Germany , Canada , the USA , Denmark , and Spain .
METHODS	Adults aged 40-85 years , with moderate-to-severe COPD , at least one acute exacerbation of COPD , and a sputum eosinophil count of 30 % or more within the previous year , were randomly assigned ( 1:1 ) via computer-generated permuted block randomisation ( block size of four ) , with an interactive voice or web-response system , to receive placebo or 100 mg benralizumab subcutaneously , every 4 weeks ( three doses ) , then every 8 weeks ( five doses ) over 48 weeks .
METHODS	Study site personnel included in study assessments , participants , and data analysts , were masked to treatment allocation .
METHODS	The primary endpoint was the annualised rate of acute exacerbations of COPD at week 56 , defined as the number of acute exacerbations divided by total duration of person-year follow-up .
METHODS	Secondary and exploratory endpoints included COPD-specific Saint George 's Respiratory Questionnaire ( SGRQ-C ) , Chronic Respiratory Questionnaire self-administered standardised format ( CRQ-SAS ) , pre-bronchodilator forced expiratory volume in 1 second ( FEV1 ) , and safety .
METHODS	We did a prespecified subgroup analysis by baseline blood eosinophil count .
METHODS	Analyses were by intention to treat and per-protocol .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01227278 .
RESULTS	We randomly assigned 101 patients to receive placebo ( n = 50 ) or benralizumab ( n = 51 ) , of whom 88 ( 87 % ) patients completed the study .
RESULTS	Six patients who completed the study were excluded from the per-protocol population because of major protocol violations ; the per-protocol population thus included 82 patients .
RESULTS	Benralizumab did not reduce the annualised rate of acute exacerbations of COPD compared with placebo in the per-protocol population , with rates of 095 ( 068-129 ; n = 40 ) versus 092 ( 067-125 ; n = 42 ) .
RESULTS	Mean pre-bronchodilator FEV1 change from baseline to week 56 was -006 L ( SD 024 ) with placebo , and 013 L ( 041 ) with benralizumab ( p = 0014 ) .
RESULTS	Numerical , albeit non-significant , improvement in acute exacerbations of COPD , SGRQ-C , CRQ-SAS , and FEV1 were greater in benralizumab-treated patients with baseline blood eosinophil concentrations of 200 cells per L or more or 300 cells per L or more .
RESULTS	Incidence of treatment-emergent adverse events was similar between the two groups , with the most common events being respiratory disorders ( 31 [ 62 % ] of 50 patients given placebo vs 32 [ 63 % ] of 51 given benralizumab ) and infections ( 28 [ 56 % ] vs 27 [ 53 % ] ) .
RESULTS	A higher incidence of serious treatment-emergent adverse events were recorded in patients in the benralizumab group than in those in the placebo group ( 14 vs nine patients ) , although none of these events were considered by the investigator to be benralizumab related .
CONCLUSIONS	Compared with placebo , benralizumab did not reduce the rate of acute exacerbations of COPD .
CONCLUSIONS	However , the results of prespecified subgroup analysis support further investigation of benralizumab in patients with COPD and eosinophilia .
BACKGROUND	MedImmune .

###25995278
BACKGROUND	Limited data are available from controlled studies on biomarkers of maternal vitamin B-12 status .
OBJECTIVE	We sought to quantify the effects of pregnancy and lactation on the vitamin B-12 status response to a known and highly controlled vitamin B-12 intake .
METHODS	As part of a 10-12 wk feeding trial , pregnant ( 26-29 wk gestation ; n = 26 ) , lactating ( 5 wk postpartum ; n = 28 ) , and control ( nonpregnant , nonlactating ; n = 21 ) women consumed vitamin B-12 amounts of 8.6 g/d [ mixed diet ( 6 g/d ) plus a prenatal multivitamin supplement ( 2.6 g/d ) ] .
METHODS	Serum vitamin B-12 , holotranscobalamin ( bioactive form of vitamin B-12 ) , methylmalonic acid ( MMA ) , and homocysteine were measured at baseline and study-end .
RESULTS	All participants achieved adequate vitamin B-12 status in response to the study dose .
RESULTS	Compared with control women , pregnant women had lower serum vitamin B-12 ( -21 % ; P = 0.02 ) at study-end , whereas lactating women had higher ( P = 0.04 ) serum vitamin B-12 throughout the study ( +26 % at study-end ) .
RESULTS	Consumption of the study vitamin B-12 dose increased serum holotranscobalamin in all reproductive groups ( +16 -42 % ; P 0.009 ) .
RESULTS	At study-end , pregnant ( vs. control ) women had a higher holotranscobalamin-to-vitamin B-12 ratio ( P = 0.04 ) with 30 % ( vs. 20 % ) of total vitamin B-12 in the bioactive form .
RESULTS	Serum MMA increased during pregnancy ( +50 % ; P < 0.001 ) but did not differ by reproductive state at study-end .
RESULTS	Serum homocysteine increased in pregnant women ( +15 % ; P = 0.009 ) but decreased in control and lactating women ( -16 -17 % ; P < 0.001 ) .
RESULTS	Despite these changes , pregnant women had 20 % lower serum homocysteine than the other 2 groups at study-end ( P 0.02 ) .
CONCLUSIONS	Pregnancy and lactation alter vitamin B-12 status in a manner consistent with enhanced vitamin B-12 supply to the child .
CONCLUSIONS	Consumption of the study vitamin B-12 dose ( 3 times the RDA ) increased the bioactive form of vitamin B-12 , suggesting that women in these reproductive states may benefit from vitamin B-12 intakes exceeding current recommendations .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01127022 .

###25872501
BACKGROUND	Early mortality for HIV-positive people starting antiretroviral therapy ( ART ) remains high in resource-limited settings , with tuberculosis the most important cause .
BACKGROUND	Existing rapid diagnostic tests for tuberculosis lack sensitivity among HIV-positive people , and consequently , tuberculosis treatment is either delayed or started empirically ( without bacteriological confirmation ) .
BACKGROUND	We developed a management algorithm for ambulatory HIV-positive people , based on body mass index and point-of-care tests for haemoglobin and urine lipoarabinomannan ( LAM ) , to identify those at high risk of tuberculosis and mortality .
BACKGROUND	We designed a clinical trial to test whether implementation of this algorithm reduces six-month mortality among HIV-positive people with advanced immunosuppression .
METHODS	The TB Fast Track study is an open , pragmatic , cluster randomised superiority trial , with 24 primary health clinics randomised to implement the intervention or standard of care .
METHODS	Adults ( aged 18years ) with a CD4 count of 150 cells/L or less , who have not received any tuberculosis treatment in the last three months , or ART in the last six months , are eligible .
METHODS	In intervention clinics , the study algorithm is used to classify individuals as at high , medium or low probability of tuberculosis .
METHODS	Those classified as high probability start tuberculosis treatment immediately , followed by ART after two weeks .
METHODS	Medium-probability patients follow the South African guidelines for test-negative tuberculosis and are reviewed within a week , to be re-categorised as low or high probability .
METHODS	Low-probability patients start ART as soon as possible .
METHODS	The primary outcome is all-cause mortality at six months .
METHODS	Secondary outcomes include severe morbidity , time to ART start and cost-effectiveness .
CONCLUSIONS	This trial will test whether a primary care-friendly management algorithm will enable nurses to identify HIV-positive patients at the highest risk of tuberculosis , to facilitate prompt treatment and reduce early mortality .
CONCLUSIONS	There remains an urgent need for better diagnostic tests for tuberculosis , especially for people with advanced HIV disease , which may render empirical treatment unnecessary .
BACKGROUND	This trial was registered with Current Controlled Trials ( identifier : ISRCTN35344604 ) on 12 September 2012 .

###25459211
BACKGROUND	Guidelines recommend gradual weight loss for the treatment of obesity , indicative of a widely held opinion that weight lost rapidly is more quickly regained .
BACKGROUND	We aimed to investigate the effect of the rate of weight loss on the rate of regain in obese people .
METHODS	For this two phase , randomised , non-masked , dietary intervention trial in a Melbourne metropolitan hospital , we enrolled 204 participants ( 51 men and 153 women ) aged 1870 years with a BMI between 30 and 45 kg/m2 .
METHODS	During phase 1 , we randomly assigned ( 1:1 ) participants with a block design ( block sizes of 2 , 4 , and 6 ) to account for sex , age , and BMI , to either a 12-week rapid weight loss or a 36-week gradual programme , both aimed at 15 % weight loss .
METHODS	We placed participants who lost 125 % or more weight during phase 1 on a weight maintenance diet for 144 weeks ( phase 2 ) .
METHODS	The primary outcome was mean weight loss maintained at week 144 of phase 2 .
METHODS	We investigated the primary outcome by both completers only and intention-to-treat analyses .
METHODS	This study is registered with the Australian New Zealand Clinical Trials Registry , number ACTRN12611000190909 .
RESULTS	200 participants were randomly assigned to the gradual weight loss ( n = 103 ) or rapid weight loss ( n = 97 ) programme between Aug 8 , 2008 , and March 9 , 2010 .
RESULTS	After phase 1 , 51 ( 50 % ) participants in the gradual weight loss group and 76 ( 81 % ) in the rapid weight loss group achieved 125 % or more weight loss in the allocated time and started phase 2 .
RESULTS	At the end of phase 2 , both gradual weight loss and rapid weight loss participants who completed the study ( n = 43 in gradual weight loss and n = 61 in rapid weight loss ) had regained most of their lost weight ( gradual weight loss 712 % regain , 95 % CI 581843 vs rapid weight loss 705 % , 578832 ) .
RESULTS	Intention-to-treat analysis showed similar results ( gradual weight loss 763 % regain , 95 % CI 652874 vs rapid weight loss 763 % , 658868 ) .
RESULTS	In phase 1 , one participant in the rapid weight loss group developed cholecystitis , requiring cholecystectomy .
RESULTS	In phase 2 , two participants in the rapid weight loss group developed cancer .
CONCLUSIONS	The rate of weight loss does not affect the proportion of weight regained within 144 weeks .
CONCLUSIONS	These findings are not consistent with present dietary guidelines which recommend gradual over rapid weight loss , based on the belief that rapid weight loss is more quickly regained .
BACKGROUND	The Australian National Health and Medical Research Council and the Sir Edward Dunlop Medical Research Foundation .

###24569437
BACKGROUND	NSABP P-1 provides an opportunity to examine the association of behavioral factors with prospectively monitored cancer incidence and interactions with tamoxifen .
METHODS	From 1992 to 1997 , 13,388 women with estimated 5-year breast cancer risk greater than 1.66 % or a history of lobular carcinoma in situ ( 87 % younger than age 65 ; 67 % postmenopausal ) were randomly assigned to tamoxifen versus placebo .
METHODS	Invasive breast cancer , lung cancer , colon cancer , and endometrial cancer were analyzed with Cox regression .
METHODS	Predictors were baseline cigarette smoking , leisure-time physical activity , alcohol consumption , and established risk factors .
RESULTS	At median 7 years follow-up , we observed 395 , 66 , 35 , and 74 breast cancer , lung cancer , colon cancer , and endometrial cancer , respectively .
RESULTS	Women who had smoked were at increased risk of breast cancer ( P = 0.007 ; HR = 1.3 for 15-35 years smoking , HR = 1.6 for 35 years ) , lung cancer ( P < 0.001 ; HR = 3.9 for 15-35 years , HR = 18.4 for 35 years ) , and colon cancer ( P < 0.001 ; HR = 5.1 for 35 years ) versus never-smokers .
RESULTS	Low activity predicted increased breast cancer risk only among women assigned to placebo ( P = 0.021 activity main effect , P = 0.013 activity-treatment interaction ; HR = 1.4 for the placebo group ) and endometrial cancer among all women ( P = 0.026 , HR = 1.7 ) .
RESULTS	Moderate alcohol ( > 0-1 drink/day ) was associated with decreased risk of colon cancer ( P = 0.019 ; HR = 0.35 ) versus no alcohol .
RESULTS	There were no other significant associations between these behaviors and cancer risk .
CONCLUSIONS	Among women with elevated risk of breast cancer , smoking has an even greater impact on breast cancer risk than observed in past studies in the general population .
CONCLUSIONS	Women who smoke or are inactive should be informed of the increased risk of multiple types of cancer .

###25490004
BACKGROUND	Extensive-stage small-cell lung cancer ( SCLC ) patients who progress after platinum-based chemotherapy are traditionally categorized as platinum sensitive ( progression 90 days from last platinum dose ) or refractory ( progression < 90 days ) , a practice arising from seminal observations of worse survival in refractory patients .
BACKGROUND	Subsequent trials accounted for platinum sensitivity , resulting in higher sample sizes and increased resource use .
METHODS	To assess whether platinum-sensitivity status remains associated with outcomes , patient-level data from recent Southwest Oncology Group trials in second - and/or third-line extensive-stage SCLC were pooled .
METHODS	Hazard ratios ( HRs ) for progression-free survival ( PFS ) and overall survival ( OS ) accounting for platinum sensitivity were calculated using unadjusted and adjusted Cox Proportional Hazard models .
METHODS	Recursive partitioning was performed to define prognostic risk groups .
RESULTS	Of 329 patients , 151 were platinum sensitive and 178 refractory .
RESULTS	HRs from unadjusted Cox PFS and OS models for refractory versus sensitive disease were 1.0 ( 95 % confidence interval , 0.81-1 .25 ; p = 0.98 ) and 1.24 ( 0.99-1 .57 ; p = 0.06 ) , respectively .
RESULTS	Adjusted Cox models showed that only elevated serum lactate dehydrogenase ( HR , 2.04 ; p < 0.001 ) , males ( HR , 1.36 ; p = 0.04 ) , performance status of 1 ( HR , 1.25 ; p = 0.02 ) , and weight loss greater than or equal to 5 % ( 1.53 , p = 0.01 ) were independently associated with OS .
RESULTS	Platinum-sensitivity status was not associated with PFS ( HR , 1.11 ; p = 0.49 ) or OS ( HR , 1.25 ; p = 0.14 ) , except in a model that excluded 36 patients who received more than one prior chemotherapy regimen ( HR , 1.34 ; p = 0.049 ) .
RESULTS	Prognostic groups with differential OS outcomes ( high , intermediate , and poor risk ) were identified .
CONCLUSIONS	Platinum-sensitivity status may no longer be strongly associated with PFS or OS in at least one multivariate model .
CONCLUSIONS	Validation of prognostic risk groups identified here is warranted .
CONCLUSIONS	These data have critical implications in the design of future SCLC trials .

###25465686
OBJECTIVE	To evaluate the effectiveness of a hydrogel sealant versus a suture in preventing fluid egress after wound leakage in cataract surgery .
METHODS	Twenty-four ophthalmic clinical practices in the United States .
METHODS	Prospective randomized parallel-arm controlled multicenter subject-masked study .
METHODS	Healthy patients having uneventful clear corneal incision ( CCI ) cataract surgery were eligible for the study .
METHODS	Spontaneous and provoked fluid egress from wounds was evaluated at the time of surgery using a calibrated force gauge .
METHODS	Eyes with leakage were randomized to receive a hydrogel sealant ( Resure ) or a nylon suture at the main incision site .
METHODS	Incision leakage was reevaluated 1 , 3 , 7 , and 28 days postoperatively .
RESULTS	Of 500 eyes , 488 had leakage at the time of cataract surgery .
RESULTS	The leak was spontaneous in 244 cases ( 48.8 % ) , and 488 ( 97.6 % ) of all incisions leaked with 1.0 ounce or less of applied force .
RESULTS	After randomization , 12 ( 4.1 % ) of 295 eyes in the sealant group and 60 ( 34.1 % ) of 176 eyes in the suture group had wound leakage with provocation ( P < .0001 ) .
RESULTS	The overall incidence of adverse ocular events was statistically significantly lower in the sealant group than in the suture group ( P < .05 ) .
CONCLUSIONS	In this study , 97.6 % of CCIs leaked after cataract surgery .
CONCLUSIONS	The hydrogel sealant was safe and effective and better than a suture for the intraoperative management of CCIs with leakage as seen on Seidel testing and for the prevention of postoperative fluid egress .

###24569062
BACKGROUND	Various methods are used to assess the height of sensory block to touch under spinal anesthesia for cesarean section .
BACKGROUND	We tested a novel , inexpensive , miniature , user-dependent plastic neurological wheel against the user-independent Neurotip mounted Neuropen .
METHODS	Patients received either spinal or combined spinal-epidural anesthesia .
METHODS	For each patient assessment , the devices were randomly assigned to one of two independent investigators .
METHODS	The order of device application was randomly permuted .
METHODS	Neither researcher was involved with anesthetic care .
METHODS	At 5-min intervals for 20 min after spinal injection , and again at the end of the operation , the levels of block to loss-of-touch sensation were assessed .
METHODS	While one investigator evaluated the block , the other left the operating room and vice versa .
METHODS	Mixed-effects regression and Bland-Altman analysis were used to weigh agreement between devices .
RESULTS	The mean difference in level-to-touch was 0.04 ( 95 % CI -0.18 , 0.27 ) dermatome levels .
RESULTS	Measurement error standard deviation associated with the Neurotip mounted Neuropen and plastic neurological wheel was 1.36 ( 95 % CI 1.26 , 1.41 ) and 1.33 ( 95 % CI 1.26 , 1.46 ) dermatome levels , respectively .
RESULTS	The difference in measurement error standard deviation was -0.03 ( 95 % CI -0.16 , 0.24 ) .
RESULTS	This evidence excludes the possibility , with 95 % confidence , of clinically significant bias or measurement error differences between methods .
RESULTS	Occasional wide variances in dermatome level were observed with both instruments at the initial assessment only .
CONCLUSIONS	The compact plastic neurological wheel is as clinically reliable as the Neurotip mounted Neuropen .

###24737152
OBJECTIVE	To determine the effects of rumen-protected choline ( RPC ) on health and reproduction in dairy cows .
METHODS	A total of 298 primi - and multiparous German Holstein cows of a high-production dairy herd ( average daily milk yield : 32 l ) were assigned randomly to a control or treatment group and were hand fed with 0 or 60 g/d of RPC as ReaShure , respectively , from 21 days before expected calving to 21 days post partum ( p. p. ) as a top dressing .
METHODS	Health data was analyzed for the incidence of fever within the first 10 days in milk ( DIM ) as well as the incidence of diseases and the culling rate within the first 200 DIM .
METHODS	Reproduction data were evaluated in terms of the calving data , uterine involution on days 10 , 21 and 42 p. p. , uterine cytology at day 42 p. p. , progesterone concentrations during weeks 3 and 5 p. p. and certain fertility measures .
METHODS	In the statistical analysis , it was differentiated between the control and treatment groups and between primi - and multiparous animals , and their interactions were analyzed .
RESULTS	The treatment group had less cows with subclinical endometritis , higher sickness rates after day 100 p. p. , lower numbers of stillbirths and more cyclic cows in week 5 p. p. compared to the control group ( p < 0.05 ) .
RESULTS	Primipara in contrast to multipara had fever more frequently , higher rates of subclinical ketosis p. p. , metritis and lameness , higher numbers of sick cows in the first 30 DIM , higher rates of stillbirths and dystocia , showed impaired involution of the uterus on day 10 p. p. , fewer animals were cyclic during week 5 p. p. and less animals were culled ( p < 0.05 ) .
RESULTS	Statistically significant interactions indicated that more heifers of the treatment group were lame , more heifers of the control group developed fever and subclinical endometritis , cows of the treatment group suffered more metritis and were sick more often in the first 30 DIM , and cows of the control group had more dystocia ( p < 0.05 ) .
CONCLUSIONS	Overall , supplementing RPC had only minor effects on the health status and reproduction .
CONCLUSIONS	Further research in other dairy herds should focus on this topic .

###24501379
BACKGROUND	Individuals with a strong family history of colorectal cancer have significant risk for colorectal cancer , although adherence to colonoscopy screening in these groups remains low .
BACKGROUND	This study assessed whether a tailored telephone counseling intervention can increase adherence to colonoscopy in members of high-risk families in a randomized , controlled trial .
METHODS	Eligible participants were recruited from two national cancer registries if they had a first-degree relative with colorectal cancer under age 60 or multiple affected family members , which included families that met the Amsterdam criteria for hereditary non-polyposis colon cancer ( HNPCC ) , and if they were due for colonoscopy within 24 months .
METHODS	Participants were randomized to receive a tailored telephone intervention grounded in behavioral theory or a mailed packet with general information about screening .
METHODS	Colonoscopy status was assessed through follow-up surveys and endoscopy reports .
METHODS	Cox proportional hazards models were used to assess intervention effect .
RESULTS	Of the 632 participants ( ages 25-80 ) , 60 % were female , the majority were White , non-Hispanic , educated , and had health insurance .
RESULTS	Colonoscopy adherence increased 11 percentage points in the tailored telephone intervention group , compared with no significant change in the mailed group .
RESULTS	The telephone intervention was associated with a 32 % increase in screening adherence compared with the mailed intervention ( HR , 1.32 ; P = 0.01 ) .
CONCLUSIONS	A tailored telephone intervention can effectively increase colonoscopy adherence in high-risk persons .
CONCLUSIONS	This intervention has the potential for broad dissemination to healthcare organizations or other high-risk populations .
CONCLUSIONS	Increasing adherence to colonoscopy among persons with increased colorectal cancer risk could effectively reduce incidence and mortality from this disease .

###25738667
BACKGROUND	Hepatitis E virus ( HEV ) is a leading cause of acute hepatitis .
BACKGROUND	The long-term efficacy of a hepatitis E vaccine needs to be determined .
METHODS	In an initial efficacy study , we randomly assigned healthy adults 16 to 65 years of age to receive three doses of either a hepatitis E vaccine ( vaccine group ; 56,302 participants ) or a hepatitis B vaccine ( control group ; 56,302 participants ) .
METHODS	The vaccines were administered at 0 , 1 , and 6 months , and the participants were followed for 19 months .
METHODS	In this extended follow-up study , the treatment assignments of all participants remained double-blinded , and follow-up assessments of efficacy , immunogenicity , and safety were continued for up to 4.5 years .
RESULTS	During the 4.5-year study period , 60 cases of hepatitis E were identified ; 7 cases were confirmed in the vaccine group ( 0.3 cases per 10,000 person-years ) , and 53 cases in the control group ( 2.1 cases per 10,000 person-years ) , representing a vaccine efficacy of 86.8 % ( 95 % confidence interval , 71 to 94 ) in the modified intention-to-treat analysis , rather than ( 95 % confidence interval , 71 to 84 ) [ corrected ] .
RESULTS	Of the participants who were assessed for immunogenicity and were seronegative at baseline , 87 % of those who received three doses of the hepatitis E vaccine maintained antibodies against HEV for at least 4.5 years ; HEV antibody titers developed in 9 % in the control group .
RESULTS	The rate of adverse events was similar in the two groups .
CONCLUSIONS	Immunization with this hepatitis E vaccine induced antibodies against HEV and provided protection against hepatitis E for up to 4.5 years .
CONCLUSIONS	( Funded by the Chinese Ministry of Science and Technology and others ; ClinicalTrials.gov number , NCT01014845 . )

###25464424
BACKGROUND	Exercise can improve physical fitness in children and adults with congenital heart disease .
BACKGROUND	We hypothesized that exercise training would not lead to adverse cardiac remodelling in this population .
RESULTS	This multi-centre randomized controlled trial included children and young adults ( 10 to 25 years ) with either corrected tetralogy of Fallot or Fontan circulation .
RESULTS	The exercise-group was enrolled in a 12 week standardized aerobic dynamic exercise training program .
RESULTS	The control-group continued their life-style and received care as usual .
RESULTS	Both groups underwent cardiopulmonary exercise testing , cardiac magnetic resonance imaging ( MRI ) , echocardiography and neurohormonal assessment , within 2 weeks before and 2 weeks after the intervention period .
RESULTS	Fifty-six patients were randomized to the exercise-group and 37 to the control-group .
RESULTS	We assessed changes between the pre - and the post-intervention period for the exercise group compared to the changes in the control-group .
RESULTS	Peak load increased significantly in the exercise-group compared to the control-group ( exercise-group 6.9 11.8 W ; control-group 0.8 13.9 W ; p = 0.047 ) .
RESULTS	There were no adverse events linked to the study .
RESULTS	Ventricular systolic parameters , cardiac dimensions and neurohormonal markers during follow-up did not change in patients allocated to the exercise-group and control-group .
RESULTS	Although there were some isolated minor changes in inflow parameters , there was no consistent pattern of changes , indicating a lack of true change in the diastolic function .
CONCLUSIONS	We demonstrated that no clinically relevant adverse cardiac remodelling occurred after 12 weeks of exercise training in patients with either corrected tetralogy of Fallot or Fontan circulation .
BACKGROUND	www.trialregister.nl , identification NTR2731 .

###25543068
OBJECTIVE	To compare the efficacy of simulation-based training between the Mimic dV - Trainer and traditional dry lab da Vinci robot training .
METHODS	A prospective randomized study analyzing the performance of 20 robotics-naive participants .
METHODS	Participants were enrolled in an online da Vinci Intuitive Surgical didactic training module , followed by training in use of the da Vinci standard surgical robot .
METHODS	Spatial ability tests were performed as well .
METHODS	Participants were randomly assigned to 1 of 2 training conditions : performance of 3 Fundamentals of Laparoscopic Surgery dry lab tasks using the da Vinci or performance of 4 dV-Trainer tasks .
METHODS	Participants in both groups performed all tasks to empirically establish proficiency criterion .
METHODS	Participants then performed the transfer task , a cystotomy closure using the daVinci robot on a live animal ( swine ) model .
METHODS	The performance of robotic tasks was blindly assessed by a panel of experienced surgeons using objective tracking data and using the validated Global Evaluative Assessment of Robotic Surgery ( GEARS ) , a structured assessment tool .
RESULTS	No statistically significant difference in surgeon performance was found between the 2 training conditions , dV-Trainer and da Vinci robot .
RESULTS	Analysis of a 95 % confidence interval for the difference in means ( -0.803 to 0.543 ) indicated that the 2 methods are unlikely to differ to an extent that would be clinically meaningful .
CONCLUSIONS	Based on the results of this study , a curriculum on the dV - Trainer was shown to be comparable to traditional da Vinci robot training .
CONCLUSIONS	Therefore , we have identified that training on a virtual reality system may be an alternative to live animal training for future robotic surgeons .

###24346594
BACKGROUND	Previously , we showed that high-dose early initiated inhaled corticosteroids during respiratory syncytial virus bronchiolitis partially and transiently prevents subsequent recurrent wheeze .
BACKGROUND	Here , we study treatment effect on lung function at age 6 .
METHODS	This is a 6-year follow-up report of a randomized placebo-controlled trial , in which 185 infants hospitalized for respiratory syncytial virus bronchiolitis were treated with early initiated , high-dose inhaled beclomethasone ( n = 86 ) or placebo ( n = 99 ) for 3 months .
METHODS	The primary outcome was forced expiratory volume in 1 second as percentage predicted .
METHODS	Secondary outcomes were bronchial hyperresponsiveness , physician-diagnosed asthma , hay fever and eczema .
METHODS	Possible toxicity was assessed by linear growth measurements .
RESULTS	At age 6 , no significant differences were found in mean forced expiratory volume in 1 second percentage predicted between beclomethasone-treated and placebo-treated patients ( 91.4 vs. 93.4 , mean difference 2.05 ( 95 % confidence interval : -1.98 to 6.08 ) .
RESULTS	The proportion of bronchial hyperresponsiveness , physician-diagnosed asthma , parent reported hay fever and eczema was comparable between groups .
RESULTS	There were no differences in linear growth .
CONCLUSIONS	Early initiated prolonged treatment with high-dose inhaled beclomethasone during hospitalization for respiratory syncytial virus infection during infancy did not improve the long-term respiratory outcome , but was safe .

###24576881
OBJECTIVE	We investigated changes in anisometropia and aniso-axial length with myopia progression in the Correction of Myopia Evaluation Trial ( COMET ) cohort .
METHODS	Of 469 myopic children , 6 to < 12 years old , enrolled in COMET , 358 were followed for 13 years .
METHODS	Cycloplegic autorefraction and axial length ( AL ) in each eye were measured annually .
METHODS	The COMET eligibility required anisometropia ( interocular difference in spherical equivalent refraction ) of 1.00 diopter ( D ) .
METHODS	For each child , a linear regression line was fit to anisometropia data by visit , and the regression slope b was used as the rate of change .
METHODS	Logistic regression was applied to identify factors for significant changes in anisometropia ( b 0.05 D/y , or a cumulative increase in anisometropia 0.50 D over 10 years ) .
METHODS	Similar analyses were applied to aniso-AL .
RESULTS	A total of 358/469 ( 76.3 % ) children had refractions at baseline and the 13-year visit .
RESULTS	The mean ( SD ) amount of anisometropia increased from 0.24 D ( 0.22 D ) at baseline to 0.49 D ( 0.46 D ) at the 13-year visit .
RESULTS	A total of 319/358 ( 89.1 % ) had slopes | b | < 0.05 D/y and 39 ( 10.9 % ) had slopes | b | 0.05 D/y , with only one negative slope .
RESULTS	Similarly , 334/358 ( 93.3 % ) children had little change in aniso-AL over time .
RESULTS	The correlation between changes in anisometropia and aniso-AL over 13 years was 0.39 ( P < 0.001 ) .
RESULTS	The correlation between changes in anisometropia and myopia progression was significant ( r = -0.36 , P < 0.001 ) .
RESULTS	No correlation was found between baseline anisometropia and myopia progression ( r = -0.02 , P = 0.68 ) .
CONCLUSIONS	Myopia and axial length progressed at a similar rate in both eyes for most children in COMET during the period of fast progression and eventual stabilization .
CONCLUSIONS	These results may be more generalizable to school-aged myopic children with limited anisometropia at baseline .
CONCLUSIONS	( ClinicalTrials.gov number , NCT00000113 . )

###25277673
OBJECTIVE	Given the long natural history of prostate cancer , we assessed differing graphical formats for imparting knowledge about the longitudinal risks of prostate cancer recurrence with or without ` hormone ' or ` androgen deprivation ' therapy .
METHODS	Male volunteers without a history of prostate cancer were randomized to 1 of 8 risk communication instruments that depicted the likelihood of prostate cancer returning or spreading over 1 , 2 , and 3 years .
METHODS	The tools differed in format ( line , pie , bar , or pictograph ) and whether the graph also included no numbers , 1 number ( indicating the number of affected individuals ) , or 2 numbers ( indicting both the number affected and the number unaffected ) .
METHODS	The main outcome variables evaluated were graphical preference and knowledge .
RESULTS	A total of 420 men were recruited ; respondents were least familiar and experienced with pictographs ( P < 0.0001 ) , and only 10 % preferred this particular format .
RESULTS	Overall accuracy ranged from 79 % to 92 % , and when assessed across all graphical subtypes , the addition of numerical information did not improve verbatim knowledge ( P = 0.1 ) .
RESULTS	Self-reported numeracy was a strong predictor of accuracy of responses ( odds ratio [ OR ] = 2.6 , P = 0.008 ) , and the impact of high numeracy varied across graphical type , having a greater impact on line ( OR = 5.1 ; 95 % confidence interval [ CI ] = 1.6-16 ; P = 0.04 ) and pie charts ( OR = 7.1 ; 95 % CI = 2.6-19 ; P = 0.01 ) , without an impact on pictographs ( OR = 0.4 ; 95 % CI = 0.1-1 .7 ; P = 0.17 ) or bar charts ( OR = 0.5 ; 95 % CI = 0.1-1 .8 ; P = 0.24 ) .
CONCLUSIONS	For longitudinal presentation of risk , baseline numeracy was strongly prognostic for outcome .
CONCLUSIONS	However , the addition of numbers to risk graphs improved only the delivery of verbatim knowledge for subjects with lower numeracy .
CONCLUSIONS	Although subjects reported the least familiarity with pictographs , they were one of the most effective means of transferring information regardless of numeracy .

###25769357
BACKGROUND	Warfarin is the most widely used oral anticoagulant worldwide , but serious bleeding complications are common .
BACKGROUND	We tested whether genetic variants can identify patients who are at increased risk of bleeding with warfarin and , consequently , those who would derive a greater safety benefit with a direct oral anticoagulant rather than warfarin .
METHODS	ENGAGE AF-TIMI 48 was a randomised , double-blind trial in which patients with atrial fibrillation were assigned to warfarin to achieve a target international normalised ratio of 20-30 , or to higher-dose ( 60 mg ) or lower-dose ( 30 mg ) edoxaban once daily .
METHODS	A subgroup of patients was included in a prespecified genetic analysis and genotyped for variants in CYP2C9 and VKORC1 .
METHODS	The results were used to create three genotype functional bins ( normal , sensitive , and highly sensitive responders to warfarin ) .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00781391 .
RESULTS	14,348 patients were included in the genetic analysis .
RESULTS	Of 4833 taking warfarin , 2982 ( 617 % ) were classified as normal responders , 1711 ( 354 % ) as sensitive responders , and 140 ( 29 % ) as highly sensitive responders .
RESULTS	Compared with normal responders , sensitive and highly sensitive responders spent greater proportions of time over-anticoagulated in the first 90 days of treatment ( median 22 % , IQR 0-202 ; 84 % , 0-258 ; and 183 % , 0-326 ; ptrend < 00001 ) and had increased risks of bleeding with warfarin ( sensitive responders hazard ratio 131 , 95 % CI 105-164 , p = 00179 ; highly sensitive responders 266 , 169-419 , p < 00001 ) .
RESULTS	Genotype added independent information beyond clinical risk scoring .
RESULTS	During the first 90 days , when compared with warfarin , treatment with edoxaban reduced bleeding more so in sensitive and highly sensitive responders than in normal responders ( higher-dose edoxaban pinteraction = 00066 ; lower-dose edoxaban pinteraction = 00036 ) .
RESULTS	After 90 days , the reduction in bleeding risk with edoxaban versus warfarin was similarly beneficial across genotypes .
CONCLUSIONS	CYP2C9 and VKORC1 genotypes identify patients who are more likely to experience early bleeding with warfarin and who derive a greater early safety benefit from edoxaban compared with warfarin .
BACKGROUND	Daiichi Sankyo .

###25312997
BACKGROUND	Research shows that multilevel factors influence healthcare delivery and patient outcomes .
BACKGROUND	The study goal was to examine how clinic type [ academic medical center ( AMC ) or federally qualified health center ( FQHC ) ] and patient characteristics influence time to resolution ( TTR ) among individuals with an abnormal cancer-screening test enrolled in a patient navigation ( PN ) intervention .
METHODS	Data were obtained from the Ohio Patient Navigation Research Project , a group-randomized trial of 862 patients from 18 clinics in Columbus , Ohio .
METHODS	TTR of patient after an abnormal breast , cervical , or colorectal screening test and the clinics ' patient and provider characteristics were obtained .
METHODS	Descriptive statistics and Cox shared frailty proportional hazards regression models of TTR were used .
RESULTS	The mean patient age was 44.8 years and 71 % of patients were white .
RESULTS	In models adjusted for study arm , FQHC patients had a 39 % lower rate of resolution than AMC patients ( P = 0.004 ) .
RESULTS	Patient factors of having a college education , private insurance , higher income , and being older were significantly associated with lower TTR .
RESULTS	After adjustment for factors that substantially affected the effect of clinic type ( patient insurance status , education level , and age ) , clinic type was not significantly associated with TTR .
CONCLUSIONS	These results suggest that TTR among individuals participating in PN programs are influenced by multiple socioeconomic patient-level factors rather than clinic type .
CONCLUSIONS	Consequently , PN interventions should be tailored to address socioeconomic status factors that influence TTR .
CONCLUSIONS	These results provide clues regarding where to target PN interventions and the importance of recognizing predictors of TTR according to clinic type .

###25152290
OBJECTIVE	To compare the application of Coopdech bronchial blocker and double lumen bronchial tube during one lung ventilation in children .
METHODS	Forty children undergoing one lung ventilation for thoracic surgery at Shantou Central Hospital from January 2012 to June 2013 , approved by hospital ethics committee , were randomized into Coopdech bronchial blocker group ( group A ) and double-lumen tube group ( group B ) .
METHODS	Anesthetic management and lung isolation were performed according to a standardized protocol .
METHODS	Two groups of children with the intubation time , intubation success rate , collapse score , the frequency of postoperative hoarseness were recorded .
METHODS	Before and after one lung ventilation in patients of the two groups of PaCO , PaO and airway pressure ( PAW ) changes were recorded .
RESULTS	The intubation time in A was longer than those of group B ( ( 224 72 ) vs ( 165 46 ) s , P < 0.05 ) , the success rate of intubation ( 100 % vs 85 % , P < 0.05 ) , collapse score in A group was higher than in group B ( 95 % vs 75 % , P < 0.05 ) , Sore throat hoarseness occurred after operation in A group was lower than in B group ( 10 % vs 35 % , P < 0.05 ) , PaO was higher in group A after one lung ventilation for 30 min ( ( 206 58 ) vs ( 148 63 ) mmHg , P < 0.05 ) , PaCO and PAW were lower than group B ( ( 36 4 ) vs ( 45 7 ) mmHg ; ( 21.6 3.2 ) vs ( 29.3 5.5 ) cm HO , P < 0.05 ) .
CONCLUSIONS	The Coodech bronchial blocker provided effective surgical exposure with less throat injuries , higher intubation success rate , lower airway pressure in children during video-assisted thoracoscopic surgery .

###25522302
OBJECTIVE	To test the hypothesis that adding obesity gene feedback ( FTO ) to simple weight control advice at a life stage with raised risk of weight gain ( university ) increases readiness to control weight .
METHODS	Individually randomized controlled trial comparing the effect of : ( i ) simple weight control advice plus FTO feedback ( FA ) and ( ii ) simple weight control advice only ( AO ) on readiness to engage with weight control .
METHODS	Differences in stage of change by genotype and differential weight control behaviors were secondary outcomes .
RESULTS	Of 1,016 participants randomized , only 279 completed follow-up , yielding 90 % power to detect a small effect for readiness to control weight .
RESULTS	As predicted , FA participants were more likely to be in the contemplation stage than AO participants ( P = 0.023 ) .
RESULTS	Participants receiving higher-risk genetic results were at a higher stage of change than controls ( P = 0.003 ) , with a trend toward a higher stage of change than those getting lower-risk results ( P = 0.051 ) .
RESULTS	Lower-risk results did not decrease weight control intentions compared with controls ( P = 0.55 ) .
RESULTS	There were no group differences in adherence to recommended weight control behaviors ( P = 0.87 ) .
CONCLUSIONS	Adding FTO feedback to weight control advice enhanced readiness to control weight , without evidence for genetic determinism , but had no more effect on behavior than weight control advice alone .

###24555511
BACKGROUND	The NOURISHED study : Nice OUtcomes for Referrals with Impulsivity , Self Harm and Eating Disorders.Eating Disorders ( ED ) and Borderline Personality Disorder ( BPD ) are both difficult to treat and the combination presents particular challenges .
BACKGROUND	Both are associated with vulnerability to loss of mentalization ( awareness of one 's own and others ' emotional state ) .
BACKGROUND	In BPD , Mentalization Based therapy ( MBT ) has been found effective in reducing symptoms .
BACKGROUND	In this trial we investigate the effectiveness and cost-effectiveness of MBT adapted for Eating disorders ( Mentalization Based Therapy for Eating Disorders ( MBT-ED ) ) compared to a standard comparison treatment , Specialist Supportive Clinical Management ( SSCM-ED ) in patients with a combination of an Eating Disorder and either a diagnosis of BPD or a history of self-harm and impulsivity in the previous 12 months .
METHODS	We will complete a multi-site single-blind randomized controlled trial ( RCT ) of MBT-ED vs SSCM-ED .
METHODS	Participants will be recruited from three Eating Disorder Services and two Borderline Personality Disorder Services in London .
METHODS	Participants allocated to MBT-ED will receive one year of weekly group and individual therapy and participants allocated to SSCM-ED will receive 20 sessions of individual therapy over 1 year .
METHODS	In addition , participants in both groups will have access to up to 5 hours of dietetic advice .
METHODS	The primary outcome measure is the global score on the Eating Disorders Examination .
METHODS	Secondary outcome measures include total score on the Zanarini BPD scale , the Object Relations Inventory , the Depression Anxiety Stress Scales , quality of life and cost-effectiveness .
METHODS	Measures are taken at recruitment and at 6 month intervals up to 18 months .
CONCLUSIONS	This is the first Randomised Controlled Trial of MBT-ED in patients with eating disorders and symptoms of BPD and will provide evidence to inform therapy decisions in this group of patients .
CONCLUSIONS	During MBT-ED mentalization is encouraged , while in SSCM-ED it is not overtly addressed .
CONCLUSIONS	This study will help elucidate mechanisms of change in the two therapies and analysis of therapy and interview transcripts will provide qualitative information about the conduct of therapy and changes in mentalization and object relations .
BACKGROUND	ISRCTN51304415 .

###24700706
BACKGROUND	Current guidelines recommend coronary artery bypass graft surgery ( CABG ) when treating significant de novo left main coronary artery ( LM ) stenosis ; however , percutaneous coronary intervention ( PCI ) has a class IIa indication for unprotected LM disease in selected patients .
BACKGROUND	This analysis compares 5-year clinical outcomes in PCI - and CABG-treated LM patients in the Synergy Between PCI With Taxus and Cardiac Surgery ( SYNTAX ) trial , the largest trial in this group to date .
RESULTS	The SYNTAX trial randomly assigned 1800 patients with LM or 3-vessel disease to receive either PCI ( with TAXUS Express paclitaxel-eluting stents ) or CABG .
RESULTS	The unprotected LM cohort ( N = 705 ) was predefined and powered .
RESULTS	Major adverse cardiac and cerebrovascular event rates at 5 years was 36.9 % in PCI patients and 31.0 % in CABG patients ( hazard ratio , 1.23 [ 95 % confidence interval , 0.95-1 .59 ] ; P = 0.12 ) .
RESULTS	Mortality rate was 12.8 % and 14.6 % in PCI and CABG patients , respectively ( hazard ratio , 0.88 [ 95 % confidence interval , 0.58-1 .32 ] ; P = 0.53 ) .
RESULTS	Stroke was significantly increased in the CABG group ( PCI 1.5 % versus CABG 4.3 % ; hazard ratio , 0.33 [ 95 % confidence interval , 0.12-0 .92 ] ; P = 0.03 ) and repeat revascularization in the PCI arm ( 26.7 % versus 15.5 % ; hazard ratio , 1.82 [ 95 % confidence interval , 1.28-2 .57 ] ; P < 0.01 ) .
RESULTS	Major adverse cardiac and cerebrovascular events were similar between arms in patients with low/intermediate SYNTAX scores but significantly increased in PCI patients with high scores ( 33 ) .
CONCLUSIONS	At 5 years , no difference in overall major adverse cardiac and cerebrovascular events was found between treatment groups .
CONCLUSIONS	PCI-treated patients had a lower stroke but a higher revascularization rate versus CABG .
CONCLUSIONS	These results suggest that both treatments are valid options for LM patients .
CONCLUSIONS	The extent of disease should accounted for when choosing between surgery and PCI , because patients with high SYNTAX scores seem to benefit more from surgery compared with those in the lower tertiles .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00114972 .

###25928515
OBJECTIVE	To analyze the efficacy of intrarectal ice application as an anesthetic method prior to transrectal ultrasound ( TRUS ) guided prostate biopsy .
METHODS	A total of 120 consecutive men were included into the study prospectively .
METHODS	Patients were equally randomized as group 1 and 2 with 60 patients each .
METHODS	Ice was applied as an anesthetic method 5 minutes before procedure to the patients in group 1 .
METHODS	Patients in group 2 were applied 10 mL of 2 % lidocaine gel 10 minutes before procedure .
METHODS	Twelve core biopsy procedure was performed for all patients .
METHODS	The pain level was evaluated using a visual analogue scale ( VAS ) .
RESULTS	Median pain score was 3.5 ( 1-8 ) in group 1 and 5 ( 1-8 ) in group 2 .
RESULTS	There is significantly difference between groups regarding the mean sense of pain level during the procedure .
RESULTS	( p = 0.007 ) There was also no difference in complications between two groups about presence and duration of macroscopic hematuria and rectal bleeding .
CONCLUSIONS	Intrarectal ice application prior to TRUS prostate biopsy has an effect on reducing pain .
CONCLUSIONS	Development of new techniques about cold effect or ice can make this method more useful and decrease complication rates .

###25293834
BACKGROUND	About six percent of pregnant women suffer from severe fear of childbirth .
BACKGROUND	These women are at increased risk of obstetric labour and delivery interventions and pre - and postpartum complications , e.g. , preterm delivery , emergency caesarean section , caesarean section at maternal request , severe postpartum fear of childbirth and trauma anxiety .
BACKGROUND	During the last decade , there is increasing clinical evidence suggesting that haptotherapy might be an effective intervention to reduce fear of childbirth in pregnant women .
BACKGROUND	The present study has been designed to evaluate the effects of such intervention .
METHODS	Included are singleton pregnant women with severe fear of childbirth , age 18 year , randomised into three arms : ( 1 ) treatment with haptotherapy , ( 2 ) internet psycho-education or ( 3 ) care as usual .
METHODS	The main study outcome is fear of childbirth .
METHODS	Measurements are taken at baseline in gestation week 20-24 , directly after the intervention is completed in gestation week 36 , six weeks postpartum and six months postpartum .
METHODS	Secondary study outcomes are distress , general anxiety , depression , somatization , social support , mother-child bonding , pregnancy and delivery complications , traumatic anxiety symptoms , duration of delivery , birth weight , and care satisfaction .
CONCLUSIONS	The treatment , a standard haptotherapeutical treatment for pregnant women with severe fear of childbirth , implies teaching a combination of skills in eight one hour sessions .
CONCLUSIONS	The internet group follows an eight-week internet course containing information about pregnancy and childbirth comparable to childbirth classes .
CONCLUSIONS	The control group has care as usual according to the standards of the Royal Dutch Organisation of Midwives and the Dutch Organization of Obstetrics and Gynaecology .
BACKGROUND	This trial was entered in the Dutch Trial Register and registered under number NTR3339 on March 4th , 2012 .

###24949544
OBJECTIVE	Low serum vitamin D levels have been associated with increased prevalence of the reproductive tract condition bacterial vaginosis ( BV ) .
OBJECTIVE	The objective of this trial was to evaluate the effect of high-dose vitamin D supplementation on BV recurrence .
METHODS	This randomized , placebo-controlled , double-blinded trial enrolled 118 women with symptomatic BV from an urban sexually transmitted disease clinic ( clinicaltrials.gov registration NCT01450462 ) .
METHODS	All participants received 500 mg of oral metronidazole twice daily for 7 days .
METHODS	Intervention participants ( n = 59 ) also received 9 doses of 50,000 IU of cholecalciferol ( vitamin D3 ) over 24 weeks ; control women ( n = 59 ) received matching placebo .
METHODS	Recurrent BV was assessed via Nugent scoring after 4 , 12 , and 24 weeks .
METHODS	We assessed the effect of the intervention using an intention-to-treat approach , fitting Cox proportional hazards models to evaluate recurrent BV over the follow-up period .
RESULTS	Most participants ( 74 % ) were black , with a median age of 26 years .
RESULTS	Median presupplementation serum 25-hydroxyvitamin D [ 25 ( OH ) D ] was similar across randomization arms : 16.6 ng/mL in the vitamin D arm and 15.8 ng/mL in the control arm .
RESULTS	At trial completion , median 25 ( OH ) D among women receiving vitamin D was 30.5 ng/mL , vs 17.8 ng/mL in control women ; 16 % of women receiving vitamin D and 57 % receiving placebo remained vitamin D deficient ( < 20 ng/mL ) .
RESULTS	BV prevalence among women randomized to vitamin D was very similar to those randomized to placebo at the 4 - and 12-week visits , but by the 24-week visit , BV prevalence was 65 % among women in the vitamin D arm and 48 % among control women .
RESULTS	BV recurrence was not reduced by vitamin D supplementation ( intention-to-treat hazard ratio , 1.11 ; 95 % confidence interval , 0.68-1 .81 ) .
RESULTS	Among women experiencing recurrent BV , median time to recurrence was 13.7 weeks in the vitamin D arm and 14.3 weeks in the control arm .
CONCLUSIONS	Women receiving vitamin D experienced significant increases in serum 25 ( OH ) D , but this increase was not associated with decreased BV recurrence in this high-risk sexually transmitted disease clinic population .

###24377647
OBJECTIVE	To compare the treatment outcomes of women with high-grade squamous intraepithelial lesions ( HSIL ) who underwent immediate loop electrosurgical excision procedure ( LEEP ) and those who had directed biopsies prior to subsequent LEEP .
METHODS	Women who were referred for HSIL to 2 centers in southeast Nigeria were examined via colposcopy .
METHODS	Those with positive colposcopic findings were randomized to receive either immediate LEEP ( see-and-treat group ) or directed biopsies ( 3-step group ) .
METHODS	Women with directed biopsy-confirmed results underwent follow-up LEEP .
METHODS	Overtreatment rate , cost , default rate , and cytology-treatment interval were compared between the 2 groups .
RESULTS	In total , 314 women were included in the study .
RESULTS	The overtreatment rate was similar between the groups .
RESULTS	Treatment cost and cytology-treatment interval were significantly higher in the 3-step group ( P = 0.0001 ) .
RESULTS	The default rate was significantly lower in the see-and-treat group ( P = 0.0001 ) .
RESULTS	Most ( 219 [ 69.7 % ] ) participants preferred the see-and-treat approach .
CONCLUSIONS	Immediate see-and-treat LEEP for women with HSIL in southeast Nigeria is cheaper , less time-consuming , and associated with better patient compliance than the 3-step management procedure .
CONCLUSIONS	Furthermore , it does not lead to significantly higher overtreatment .
CONCLUSIONS	The immediate see-and-treat approach may be ideal for the management of women with HSIL in low-resource countries .

###25227704
OBJECTIVE	To investigate the cost effectiveness of ticagrelor versus clopidogrel in patients with acute coronary syndromes ( ACS ) in the Platelet Inhibition and Patient Outcomes ( PLATO ) study who were scheduled for non-invasive management .
METHODS	A previously developed cost effectiveness model was used to estimate long-term costs and outcomes for patients scheduled for non-invasive management .
METHODS	Healthcare costs , event rates and health-related quality of life under treatment with either ticagrelor or clopidogrel over 12months were estimated from the PLATO study .
METHODS	Long-term costs and health outcomes were estimated based on data from PLATO and published literature sources .
METHODS	To investigate the importance of different healthcare cost structures and life expectancy for the results , the analysis was carried out from the perspectives of the Swedish , UK , German and Brazilian public healthcare systems .
RESULTS	Ticagrelor was associated with lifetime quality-adjusted life-year ( QALY ) gains of 0.17 in Sweden , 0.16 in the UK , 0.17 in Germany and 0.13 in Brazil compared with generic clopidogrel , with increased healthcare costs of 467 , 551 , 739 and 574 , respectively .
RESULTS	The cost per QALY gained with ticagrelor was 2747 , 3395 , 4419 and 4471 from a Swedish , UK , German and Brazilian public healthcare system perspective , respectively .
RESULTS	Probabilistic sensitivity analyses indicated that the cost per QALY gained with ticagrelor was below conventional threshold values of cost effectiveness with a high probability .
CONCLUSIONS	Treatment of patients with ACS scheduled for 12months ' non-invasive management with ticagrelor is associated with a cost per QALY gained below conventional threshold values of cost effectiveness compared with generic clopidogrel .
BACKGROUND	NCT000391872 .

###25031289
BACKGROUND	Ceftriaxone is the foundation of currently recommended gonorrhea treatment .
BACKGROUND	There is an urgent need for backup treatment options for patients with cephalosporin allergy or infections due to suspected cephalosporin-resistant Neisseria gonorrhoeae .
BACKGROUND	We evaluated the efficacy and tolerability of 2 combinations of existing noncephalosporin antimicrobials for treatment of patients with urogenital gonorrhea .
METHODS	We conducted a randomized , multisite , open-label , noncomparative trial in 5 outpatient sexually transmitted disease clinic sites in Alabama , California , Maryland , and Pennsylvania .
METHODS	Patients aged 15-60 years diagnosed with uncomplicated urogenital gonorrhea were randomly assigned to either gentamicin 240 mg intramuscularly plus azithromycin 2 g orally , or gemifloxacin 320 mg orally plus azithromycin 2 g orally .
METHODS	The primary outcome was microbiological cure of urogenital infections ( negative follow-up culture ) at 10-17 days after treatment among 401 participants in the per protocol population .
RESULTS	Microbiological cure was achieved by 100 % ( lower 1-sided exact 95 % confidence interval [ CI ] bound , 98.5 % ) of 202 evaluable participants receiving gentamicin/azithromycin , and 99.5 % ( lower 1-sided exact 95 % CI bound , 97.6 % ) of 199 evaluable participants receiving gemifloxacin/azithromycin .
RESULTS	Gentamicin/azithromycin cured 10 of 10 pharyngeal infections and 1 of 1 rectal infection ; gemifloxacin/azithromycin cured 15 of 15 pharyngeal and 5 of 5 rectal infections .
RESULTS	Gastrointestinal adverse events were common in both arms .
CONCLUSIONS	Gentamicin/azithromycin and gemifloxacin/azithromycin were highly effective for treatment of urogenital gonorrhea .
CONCLUSIONS	Gastrointestinal adverse events may limit routine use .
CONCLUSIONS	These non-cephalosporin-based regimens may be useful alternative options for patients who can not be treated with cephalosporin antimicrobials .
CONCLUSIONS	Additional treatment options for gonorrhea are needed .
CONCLUSIONS	Clinical Trials Registration .
CONCLUSIONS	NCT00926796 .

###26092673
BACKGROUND	Targeted temperature management is recommended after out-of-hospital cardiac arrest .
BACKGROUND	Whether advanced internal cooling is superior to basic external cooling remains unknown .
BACKGROUND	The aim of this multicenter , controlled trial was to evaluate the benefit of endovascular versus basic surface cooling .
RESULTS	Inclusion criteria were the following : age of 18 to 79 years , out-of-hospital cardiac arrest related to a presumed cardiac cause , time to return of spontaneous circulation < 60 minutes , delay between return of spontaneous circulation and inclusion < 240 minutes , and unconscious patient after return of spontaneous circulation and before the start of cooling .
RESULTS	Exclusion criteria were terminal disease , pregnancy , known coagulopathy , uncontrolled bleeding , temperature on admission < 30C , in-hospital cardiac arrest , immediate need for extracorporeal life support or hemodialysis .
RESULTS	Patients were randomized between 2 cooling strategies : endovascular femoral devices ( Icy catheter , Coolgard , Zoll , formerly Alsius ; n = 203 ) or basic external cooling using fans , a homemade tent , and ice packs ( n = 197 ) .
RESULTS	The primary end point , that is , favorable outcome evaluated by survival without major neurological damage ( Cerebral Performance Categories 1-2 ) at day 28 , was not significantly different between groups ( odds ratio , 1.41 ; 95 % confidence interval , 0.93-2 .16 ; P = 0.107 ) .
RESULTS	Improvement in favorable outcome at day 90 in favor of the endovascular group did not reach significance ( odds ratio , 1.51 ; 95 % confidence interval , 0.96-2 .35 ; P = 0.07 ) .
RESULTS	Time to target temperature ( 33C ) was significantly shorter and target hypothermia was more strictly maintained in the endovascular than in the surface group ( P < 0.001 ) .
RESULTS	Minor side effects directly related to the cooling method were observed more frequently in the endovascular group ( P = 0.009 ) .
CONCLUSIONS	Despite better hypothermia induction and maintenance , endovascular cooling was not significantly superior to basic external cooling in terms of favorable outcome .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00392639 .

###24796793
OBJECTIVE	Cognitive comorbidity at epilepsy onset reflects disease severity and provides a baseline estimate of reserve capacities with regard to the effects of epilepsy and its treatment .
OBJECTIVE	Given the high incidence of epilepsy at an older age , this study analyzed objective and subjective cognition as well as quality of life in elderly patients with new-onset focal epilepsy before initiation of anti-epileptic treatment .
METHODS	A total of 257 untreated patients ( 60-95 years of age ) with new-onset epilepsy underwent objective assessment of executive function ( EpiTrack ) and performed subjective ratings of cognition ( Portland Neurotoxicity Scale ) and quality of life ( QoL ; QOLIE-31 ) .
RESULTS	According to age-corrected norms , 58 % of patients ( N = 257 ) demonstrated deficits in executive function ; major determinants were cerebrovascular etiology , neurological comorbidity , and higher body mass index .
RESULTS	Subjective ratings indicated deficits in up to 27 % of patients .
RESULTS	Self-perceived deficits were associated with neurological , cardiovascular , and/or psychiatric comorbidity , whereas poorer QoL was related to neurological comorbidity and female gender .
RESULTS	Objectively assessed executive functions correlated with subjective social functioning , energy , motor function , and vigilance .
CONCLUSIONS	We found a relatively high QoL , a low rate of subjective impairment , but a high incidence of objective executive deficits in untreated elderly patients with new-onset epilepsy .
CONCLUSIONS	Neurological status and body mass index , rather than seizure frequency or severity , were risk factors for cognitive impairment .
CONCLUSIONS	Given the relevance of cognition in the course of epilepsy and its treatment , routine screening before treatment initiation is highly recommended .

###24261608
BACKGROUND	The potential interest of antifungal treatment of non-immunocompromized patients with sepsis , extra-digestive Candida colonization and multiple organ failure is unknown .
BACKGROUND	It represents three-quarters of antifungals prescribed in Intensive Care Units .
BACKGROUND	It may allow early treatment of invasive fungal infection in the incubation phase but expose patients to unnecessary antifungal treatments with subsequent cost and fungal selection pressure .
BACKGROUND	As early diagnostic tests for invasive candidiasis are still considered to be insufficient , the potential interest in this strategy needs to be demonstrated .
METHODS	This prospective multicenter , double blind , randomized-controlled trial is conducted in 23 French Intensive Care Units .
METHODS	All adult patients , mechanically ventilated for more than four days with sepsis of unknown origin and with at least one extradigestive fungal colonization site and multiple organ failure are eligible for randomization .
METHODS	Patients with proven invasive candidiasis are not included .
METHODS	After a complete mycological screening , patients are allocated to receive micafungin 100 mg intravenously once a day or placebo for 14 days .
METHODS	We plan to enroll 260 patients .
METHODS	The main objective is to demonstrate that micafungin increases survival of patients without invasive candidiasis at day 28 as compared to placebo .
METHODS	Other outcomes include day 28 and 90 survival and organ failure evolution .
METHODS	Additionally , pharmacokinetics of micafungin in enrolled patients will be measured and evolution of fungal biomarkers and susceptibility profiles of infecting fungi will also be followed .
CONCLUSIONS	This study will help to provide guidelines for treating non-immunocompromized patients with fungal colonization multiple organ failure and sepsis of unknown origin .
BACKGROUND	Clinicaltrials.gov number NCT01773876 .

###24498853
BACKGROUND	We evaluated the efficacy and safety of the aromatase inhibitor exemestane in patients with advanced , persistent or recurrent endometrial carcinoma .
METHODS	We performed an open-label one-arm , two-stage , phase II study of 25 mg of oral exemestane in 51 patients with advanced ( FIGO stage III-IV ) or relapsed endometrioid endometrial cancer .
METHODS	Patients were stratified into subsets of estrogen receptor ( ER ) positive and ER negative patients .
RESULTS	Recruitment to the ER negative group was stopped prematurely after 12 patients due to slow accrual .
RESULTS	In the ER positive patients , we observed an overall response rate of 10 % , and a lack of progression after 6 months in 35 % of the patients .
RESULTS	No responses were registered in the ER negative patients , and all had progressive disease within 6 months .
RESULTS	For the total group of patients , the median progression free survival ( PFS ) was 3.1 months ( 95 % CI : 2.0-4 .1 ) .
RESULTS	In the ER positive patients the median PFS was 3.8 months ( 95 % CI : 0.7-6 .9 ) and in the ER negative patients it was 2.6 months ( 95 % CI : 2.1-3-1 ) .
RESULTS	In the ER positive patients the median overall survival ( OS ) time was 13.3 months ( 95 % CI : 7.7-18 .9 ) , in the ER negative patients the corresponding numbers were 6.1 months ( 95 % CI : 4.1-8 .2 ) .
RESULTS	Treatment with exemestane was well tolerated .
CONCLUSIONS	Treatment of estrogen positive advanced or recurrent endometrial cancer with exemestane , an aromatase inhibitor , resulted in a response rate of 10 % and lack of progression after 6 months in 35 % of the patients .
BACKGROUND	Trial identification number ( Clinical Trials.gov ) : NCT01965080.Nordic Society of Gynecological Oncology : NSGO-EC-0302 .
BACKGROUND	EudraCT number : 2004-001103-35 .

###25502343
BACKGROUND	Severe angulation or shortening can be a surgical indication for fifth metacarpal neck fracture .
BACKGROUND	In a previous meta-analysis , antegrade intramedullary pinning was shown to produce better hand function outcomes than percutaneous transverse pinning or miniplate fixation for treatment of fifth metacarpal neck fractures .
BACKGROUND	However , the outcomes of retrograde intramedullary pinning , to our knowledge , have not been compared with those of antegrade intramedullary pinning .
OBJECTIVE	We asked whether the clinical and radiographic outcomes of antegrade intramedullary pinning are different from those of percutaneous retrograde intramedullary pinning for treating patients with displaced fifth metacarpal neck fractures .
METHODS	Forty-six patients with displaced fifth metacarpal neck fractures with an apex dorsal angulation greater than 30 were enrolled in our prospective study .
METHODS	Subjects were treated randomly by antegrade intramedullary pinning ( antegrade group ) or by percutaneous retrograde intramedullary pinning ( retrograde group ) .
METHODS	Clinical evaluations , which included active ROM of the fifth metacarpophalangeal joint , VAS for pain , grip strength , and DASH score , were performed at 3 months and 6 months postoperatively .
METHODS	Radiographic evaluations of apex dorsal angulation and axial shortening were performed preoperatively and 6 months postoperatively .
RESULTS	Patients in the antegrade group achieved better outcomes than patients in the retrograde group for all clinical parameters at 3 months postoperatively ( ROM : antegrade median 80 [ range , 57-90 ] versus retrograde 69 [ range , 45-90 ] , difference of medians 11 , p < 0.001 ; VAS : antegrade median of 2 [ range , 0-5 ] versus retrograde 4 [ range , 0-7 ] , difference of medians 2 , p < 0.001 ; grip strength : antegrade median 81 % [ range , 60 % -100 % ] versus retrograde 71 % [ range , 49 % -98 % ] , differences of medians 10 % , p < 0.001 ; DASH : antegrade median 4.3 [ range , 0-15 .8 ] versus retrograde 10.3 [ range , 0-28 .4 ] , difference of medians 6 , p < 0.001 ) , but these differences , with the numbers available , were not observed at 6 months postoperatively for any clinical parameters ( ROM : antegrade median 88 [ range , 81-90 ] versus retrograde 87 [ range , 80-90 ] , difference of medians 1 , p = 0.35 ; VAS : antegrade median 1 [ range , 0-2 ] versus retrograde 1 [ range , 0-3 ] , difference of medians 0 , p = 0.67 ; grip strength : antegrade median 93 % [ range , 78 % -104 % ] versus retrograde 91 % [ range , 76 % -101 % ] , difference of medians 2 % , p = 0.41 ; DASH : antegrade median 3 [ range , 0-12 .5 ] versus retrograde of 4.3 [ range , 0-15 .8 ] , difference of medians 1.3 , p = 0.48 ) .
RESULTS	At 6 months postoperatively , there also were no differences , with the numbers available , in radiographic parameters between the antegrade and retrograde fixation groups .
RESULTS	Residual angulation was not different ( antegrade median : 7 [ range , 2-11 ] , retrograde : 9 [ range , 3-13 ] , difference of medians 2 , p = 0.56 ) .
RESULTS	Shortening between the two groups also was not different ( antegrade median : 1 mm [ range , 0 mm-2 mm ] , retrograde median : 1 mm [ range , 0 mm-2 mm ] , difference of medians 0 , p = 0.78 ) .
CONCLUSIONS	Our study findings suggest antegrade intramedullary pinning has some clinical advantages during the early recovery period over percutaneous retrograde intramedullary pinning for treatment of displaced fifth metacarpal neck fractures , but the advantages are not evident at 6 months postoperatively .
CONCLUSIONS	In addition , our study showed no differences in radiographic outcomes between antegrade and retrograde techniques .
CONCLUSIONS	For patients who require an early return of hand function , such as athletes , antegrade intramedullary pinning can be recommended .
CONCLUSIONS	Otherwise , treatment could be decided according to the surgeon 's preference and patient status , and based on consideration of the need for an accessory procedure for pin removal after antegrade intramedullary pinning .
METHODS	Level I , therapeutic study .

###24958410
OBJECTIVE	Bedside sonography has become a popular method of assessment of critically ill patients with shock and dyspnea .
OBJECTIVE	This study evaluated the usefulness of integrated cardiopulmonary sonography for assessment of acute pulmonary edema .
METHODS	A total of 128 intensive care unit ( ICU ) patients with acute pulmonary edema were randomly divided into 2 groups : a sonography group , which received standard treatment as well as cardiopulmonary sonography , and a control group , which received standard treatment only .
METHODS	All patients were treated according to the same therapeutic strategies and underwent chest radiography and central venous catheter placement .
METHODS	Serum myocardial injury marker levels and central venous/arterial blood gas parameters were measured 0 , 24 , and 72 hours after enrollment .
METHODS	The cumulative fluid infusion volume at 6 , 12 , 24 , and 72 hours , the time to diagnosis of the pulmonary edema etiology by the attending physician , the lengths of ICU and hospital stays , and ICU mortality were recorded .
RESULTS	The sonography group had a shorter time to diagnosis and received a smaller fluid infusion volume than the control group .
RESULTS	There were no significant differences in ICU mortality and lengths of ICU and hospital stays between the sonography and control groups .
RESULTS	In patients with cardiogenic pulmonary edema , the sonography group had a significantly shorter ICU stay and a faster return to normal myocardial injury marker levels and perfusion parameters than the control group ( P < .05 ) .
CONCLUSIONS	Integrated cardiopulmonary sonography resulted in faster and better-informed clinical decision making , shortened the time to diagnosis of the pulmonary edema etiology , and decreased fluid use .
CONCLUSIONS	However , the impact of this examination on prognoses requires further study .
CONCLUSIONS	We propose that integrated cardiopulmonary sonography may be a useful bedside tool for treatment of ICU patients with acute pulmonary edema .

###25122647
BACKGROUND	Biotin functions as a cofactor for several carboxylase enzymes with key roles in metabolism .
BACKGROUND	At present , the dietary requirement for biotin is unknown and intake recommendations are provided as Adequate Intakes ( AIs ) .
BACKGROUND	The biotin AI for adults and pregnant women is 30 g/d , whereas 35 g/d is recommended for lactating women .
BACKGROUND	However , pregnant and lactating women may require more biotin to meet the demands of these reproductive states .
OBJECTIVE	The current study sought to quantify the impact of reproductive state on biotin status response to a known dietary intake of biotin .
METHODS	To achieve this aim , we measured a panel of biotin biomarkers among pregnant ( gestational week 27 at study entry ; n = 26 ) , lactating ( postnatal week 5 at study entry ; n = 28 ) , and control ( n = 21 ) women who participated in a 10 - to 12-wk feeding study providing 57 g of dietary biotin/d as part of a mixed diet .
RESULTS	Over the course of the study , pregnant women excreted 69 % more ( vs. control ; P < 0.001 ) 3-hydroxyisovaleric acid ( 3-HIA ) , a metabolite that accumulates during the catabolism of leucine when the activity of biotin-dependent methylcrotonyl-coenzyme A carboxylase is impaired .
RESULTS	Interestingly , urinary excretion of 3-hydroxyisovaleryl-carnitine ( 3-HIA-carnitine ) , a downstream metabolite of 3-HIA , was 27 % lower ( P = 0.05 ) among pregnant ( vs. control ) women , a finding that may arise from carnitine inadequacy during gestation .
RESULTS	No differences ( P > 0.05 ) were detected in plasma biotin , urinary biotin , or urinary bisnorbiotin between pregnant and control women .
RESULTS	Lactating women excreted 76 % more ( vs. control ; P = 0.001 ) of the biotin catabolite bisnorbiotin , indicating that lactation accelerates biotin turnover and loss .
RESULTS	Notably , with respect to control women , lactating women excreted 23 % less ( P = 0.04 ) urinary 3-HIA and 26 % less ( P = 0.05 ) urinary 3-HIA-carnitine , suggesting that lactation reduces leucine catabolism and that these metabolites may not be useful indicators of biotin status during lactation .
CONCLUSIONS	Overall , these data demonstrate significant alterations in markers of biotin metabolism during pregnancy and lactation and suggest that biotin intakes exceeding current recommendations are needed to meet the demands of these reproductive states .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01127022 .

###25086065
BACKGROUND	Although platelet-rich plasma ( PRP ) has been used in rotator cuff repair , most authors have been unable to report the advantages of this method in clinical trials .
OBJECTIVE	The use of PRP promotes better functional and structural results in arthroscopic rotator cuff repair .
METHODS	Randomized controlled trial ; Level of evidence , 1 .
METHODS	This was a prospective , randomized , double-blind study with 2 groups of 27 patients each ( PRP group and control group ) .
METHODS	Complete supraspinatus tears with retraction of less than 3 cm were subjected to arthroscopic single-row repair ; at the end of the surgical procedure , liquid PRP prepared by apheresis was given to the patients in the PRP group with autologous thrombin .
METHODS	The outcomes were assessed by the University of California at Los Angeles ( UCLA ) and Constant scales , visual analog scale ( VAS ) for pain , and magnetic resonance imaging ( MRI ) before and 3 , 6 , 12 , and 24 months after surgery .
METHODS	The significance level was 5 % .
RESULTS	The 2 groups of patients exhibited significant clinical improvement ( P < .001 ) .
RESULTS	Between the preoperative assessment and 24-month follow-up , the mean UCLA score increased from 13.63 3.639 to 32.70 3.635 and from 13.93 4.649 to 32.44 4.318 in the control and PRP groups , respectively ( P = .916 ) .
RESULTS	The mean Constant score increased from 47.37 11.088 to 85.15 9.879 in the control group and from 46.96 11.937 to 84.78 14.048 in the PRP group ( P = .498 ) .
RESULTS	The mean VAS score varied from 7.00 1.939 and 6.67 1.617 before surgery to 1.15 1.916 and 0.96 2.244 at the 24-month assessment in the control and PRP groups , respectively ( P = .418 ) .
RESULTS	The only difference was in the mean UCLA score at 12 months , with 30.04 4.528 in the control group and 32.30 3.506 in the PRP group ( P = .046 ) .
RESULTS	The control group exhibited 1 case of a complete retear and 4 partial retears , and the PRP group exhibited 2 cases of partial retears ( P = .42 ) .
CONCLUSIONS	Platelet-rich plasma prepared by apheresis and applied in the liquid state with thrombin did not promote better clinical results at 24-month follow-up .
CONCLUSIONS	Given the numbers available for analysis , the retear rate also did not change .

###25486675
BACKGROUND	Effective interventions are needed to reduce neurobehavioral impairments in children due to maternal alcohol use during pregnancy .
BACKGROUND	Currently , health-counseling interventions have shown inconsistent results to reduce prenatal alcohol use .
BACKGROUND	Thus , more research using health counseling is needed to gain more knowledge about the effectiveness of this type of intervention on reducing alcohol use during pregnancy .
BACKGROUND	An alternative and promising strategy is computer tailoring .
BACKGROUND	However , to date , no study has shown the effectiveness of this intervention mode .
OBJECTIVE	The aim was to test the effectiveness of health counseling and computer tailoring on stopping and reducing maternal alcohol use during pregnancy in a Dutch sample of pregnant women using alcohol .
METHODS	A total of 60 Dutch midwifery practices , randomly assigned to 1 of 3 conditions , recruited 135 health counseling , 116 computer tailoring , and 142 usual care respondents from February to September 2011 .
METHODS	Health-counseling respondents received counseling from their midwife according to a health-counseling protocol , which consisted of 7 steps addressed in 3 feedback sessions .
METHODS	Computer-tailoring respondents received usual care from their midwife and 3 computer-tailored feedback letters via the Internet .
METHODS	Usual care respondents received routine alcohol care from their midwife .
METHODS	After 3 and 6 months , we assessed the effect of the interventions on alcohol use .
RESULTS	Multilevel multiple logistic regression analyses showed that computer-tailoring respondents stopped using alcohol more often compared to usual care respondents 6 months after baseline ( 53/68 , 78 % vs 51/93 , 55 % ; P = .04 ) .
RESULTS	Multilevel multiple linear regression analyses showed that computer-tailoring respondents ( mean 0.35 , SD 0.31 units per week ) with average ( P = .007 ) or lower ( P < .001 ) alcohol use before pregnancy or with average ( P = .03 ) or lower ( P = .002 ) social support more strongly reduced their alcohol use 6 months after baseline compared to usual care respondents ( mean 0.48 , SD 0.54 units per week ) .
RESULTS	Six months after baseline , 72 % ( 62/86 ) of the health-counseling respondents had stopped using alcohol .
RESULTS	This 17 % difference with the usual care group was not significant .
CONCLUSIONS	This is the first study showing that computer tailoring can be effective to reduce alcohol use during pregnancy ; health counseling did not effectively reduce alcohol use .
CONCLUSIONS	Future researchers developing a health-counseling intervention to reduce alcohol use during pregnancy are recommended to invest more in recruitment of pregnant women and implementation by health care providers .
CONCLUSIONS	Because pregnant women are reluctant to disclose their alcohol use to health professionals and computer tailoring preserves a person 's anonymity , this effective computer-tailoring intervention is recommended as an attractive intervention for pregnant women using alcohol .
BACKGROUND	Dutch Trial Register NTR 2058 ; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2058 ( Archived by WebCite at http://www.webcitation.org/6NpT1oHol ) .

###25282679
OBJECTIVE	The purpose of this study was to investigate the effect of active vs passive scapular correction on pain and pressure pain threshold at the most symptomatic cervical segment in patients with chronic neck pain .
METHODS	Twenty-three volunteers with chronic , idiopathic neck pain were recruited ( age , 38.9 14.4 years ; sex [ man/woman ] , 3/20 ; Neck Disability Index , 28.1 % 9.9 % ) .
METHODS	Subjects were randomly allocated to 2 groups : active scapular correction or passive scapular correction .
METHODS	Pressure pain threshold and pain intensity rated on a numerical rating scale during a posteroanterior glide over the most symptomatic cervical segment were measured before and immediately after the active or passive scapular intervention .
RESULTS	Only the active scapular correction produced a reduction in pain ( pre , 6.3 1.2 ; post , 3.7 2.4 ; P < .05 ) and increase in pressure pain threshold ( pre , 8.7 4.2 kg/cm ( 2 ) ; post , 10.1 3.8 kg/cm ( 2 ) ; P < .05 ) at the most painful cervical segment .
CONCLUSIONS	An active scapular correction exercise resulted in an immediate reduction of pain and pressure pain sensitivity in patients with chronic neck pain and scapular dysfunction .

###25335962
BACKGROUND	Ginger-salt-indirect moxibustion is widely applied to treat urge urinary incontinence after stroke , which is a common complication in stroke survivors .
BACKGROUND	Moxa cone moxibustion and moxa box moxibustion are the main techniques of ginger-salt-indirect moxibustion .
BACKGROUND	Our previous study had shown that ginger-salt-indirect moxibustion using moxa cones was feasible and effective for urination disorders post-stroke .
BACKGROUND	This pilot study aims to assess the feasibility of conducting research to evaluate the efficacy and safety of ginger-salt-indirect moxibustion for patients with post-stroke urge urinary incontinence .
METHODS	This is a multicentre , prospective , single-blinded , pilot randomised controlled trial .
METHODS	120 eligible patients will be randomly allocated to three groups .
METHODS	Treatment group A ( n = 40 ) will receive moxa cone moxibustion and routine care ; treatment group B ( n = 40 ) will receive moxa box moxibustion and routine care ; control group ( n = 40 ) will only receive routine care for stroke recovery .
METHODS	The entire moxibustion treatment will consist of a total of 28 sessions during the course of 4weeks .
METHODS	The primary outcome measure will be the increase in mean volume per void assessed at week 4 from the first moxibustion session ( baseline ) .
METHODS	Secondary outcome measures will include mean frequency of urination per day and quality of life assessments measured by completion of the Incontinence Quality of Life Questionnaire and Barthel Index .
METHODS	All outcome measures will be assessed at baseline and at 4 and 16weeks from baseline .
METHODS	Adverse events in the three groups will be recorded to assess the safety of moxibustion .
BACKGROUND	Research ethics was approved by the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine Affiliated to the Capital Medical University ( ref : 2013BL-094 ) .
BACKGROUND	Written informed consent will be obtained from all participants .
BACKGROUND	Study results will be published in peer reviewed journals .
BACKGROUND	ISRCTN 44706974 .

###25254433
OBJECTIVE	As public discourse surrounding obesity highlights the societal costs of obesity and individual 's own responsibility for their weight , being overweight is often framed as immoral .
OBJECTIVE	Such ` moralizing ' messages about being overweight may be a psychological threat for those with high body mass .
OBJECTIVE	Attempting to counter-moralise the public discourse ( i.e. actively arguing that there is nothing ` immoral ' about being overweight ) may relieve this threat , inducing people , especially those with higher ( perceived ) weight , to engage in healthier behaviours .
METHODS	Two experiments were performed among Dutch and US participants .
METHODS	( Counter - ) moralisation was manipulated .
METHODS	Body mass and weight-related self-perceptions were measured .
METHODS	The dependent variable was healthy vs. unhealthy snack choice .
RESULTS	( Counter - ) moralisation and ( perceived ) overweight jointly predicted snack choice : counter-moralising messages induced healthy snacking , but only among those who regarded themselves to have a high body mass .
CONCLUSIONS	The effects of moralising vs. counter-moralising obesity depended on one 's ( perceived ) overweight .
CONCLUSIONS	This suggests that , for people with relatively high weight , the current moralising public discourse on obesity works in counterproductive ways .
CONCLUSIONS	Campaigns that ` counter-moralize ' obesity ( i.e. that refute moralising messages ) are more productive , although they should be tailored to those who see themselves as being overweight .

###24928805
BACKGROUND	Whether initial treatment for Parkinson 's disease should consist of levodopa , dopamine agonists , or monoamine oxidase type B inhibitors ( MAOBI ) is uncertain .
BACKGROUND	We aimed to establish which of these three classes of drug , as initial treatment , provides the most effective long-term control of symptoms and best quality of life for people with early Parkinson 's disease .
METHODS	In this pragmatic , open-label randomised trial , patients newly diagnosed with Parkinson 's disease were randomly assigned ( by telephone call to a central office ; 1:1:1 ) between levodopa-sparing therapy ( dopamine agonists or MAOBI ) and levodopa alone .
METHODS	Patients and investigators were not masked to group assignment .
METHODS	Primary outcomes were the mobility dimension on the 39-item patient-rated Parkinson 's disease questionnaire ( PDQ-39 ) quality-of-life scale ( range 0-100 with six points defined as the minimally important difference ) and cost-effectiveness .
METHODS	Analysis was intention to treat .
METHODS	This trial is registered , number ISRCTN69812316 .
RESULTS	Between Nov 9 , 2000 , and Dec 22 , 2009 , 1620 patients were assigned to study groups ( 528 to levodopa , 632 to dopamine agonist , 460 to MAOBI ) .
RESULTS	With 3-year median follow-up , PDQ-39 mobility scores averaged 18 points ( 95 % CI 05-30 , p = 0005 ) better in patients randomly assigned to levodopa than those assigned to levodopa-sparing therapy , with no increase or attrition of benefit during 7 years ' observation .
RESULTS	PDQ-39 mobility scores were 14 points ( 95 % CI 00-29 , p = 005 ) better in patients allocated MAOBI than in those allocated dopamine agonists .
RESULTS	EQ-5D utility scores averaged 003 ( 95 % CI 001-005 ; p = 00002 ) better with levodopa than with levodopa-sparing therapy ; rates of dementia ( hazard ratio [ HR ] 081 , 95 % CI 061-108 , p = 014 ) , admissions to institutions ( 086 , 063-118 ; p = 04 ) , and death ( 085 , 069-106 , p = 017 ) were not significantly different , but the upper CIs precluded any substantial increase with levodopa compared with levodopa-sparing therapy .
RESULTS	179 ( 28 % ) of 632 patients allocated dopamine agonists and 104 ( 23 % ) of 460 patients allocated MAOBI discontinued allocated treatment because of side-effects compared with 11 ( 2 % ) of 528 patients allocated levodopa ( p < 00001 ) .
CONCLUSIONS	Very small but persistent benefits are shown for patient-rated mobility scores when treatment is initiated with levodopa compared with levodopa-sparing therapy .
CONCLUSIONS	MAOBI as initial levodopa-sparing therapy was at least as effective as dopamine agonists .
BACKGROUND	UK National Institute for Health Research Health Technology Assessment Programme and UK Department of Health .

###24698346
OBJECTIVE	Observational studies suggest that moderate intakes of retinol and increased circulating retinol levels may increase fracture risk .
OBJECTIVE	Easy access to supplements , combined with an aging population , makes this a potentially important association .
OBJECTIVE	The aim of this study was to investigate plasma retinol and total carotene concentrations in relation to fracture risk after long-term supplementation with retinol and/or beta-carotene in 998 adults between 1990 and 2007 .
METHODS	Participants were 663 men and 335 women in a cancer prevention program who were initially randomized to a retinol ( 7.5 mg RE/d ) or beta-carotene ( 30 mg/d ) supplement between 1990 and 1996 .
METHODS	After 1996 , all participants received the retinol supplement only .
METHODS	Plasma retinol and total carotene , medication use and various lifestyle factors were measured at annual clinic visits .
METHODS	Fractures were identified by self-report in 2007 .
METHODS	The risk for any fracture or osteoporotic fracture was modeled using Cox proportional hazard models .
RESULTS	Over a median follow-up of 7.8 y , 123 participants with plasma samples reported an incident fracture .
RESULTS	Although plasma retinol concentrations were markedly higher than those reported in observational studies , no association was observed between plasma retinol and risk for any fracture ( hazard ratio [ HR ] , 0.86 mol/L ; 95 % confidence interval [ CI ] , 0.65-1 .14 ) or osteoporotic fracture ( HR , 0.97 mol/L ; 95 % CI , 0.66-1 .43 ) .
RESULTS	A lower risk for any fracture was suggested with increasing plasma total carotenes ( HR , 0.85 mol/L ; 95 % CI , 0.71-1 .01 ) .
CONCLUSIONS	This study does not support earlier reports of an increased fracture risk associated with increased plasma retinol concentration .
CONCLUSIONS	The potential for carotenes to prevent fractures deserves further investigation .

###24638071
OBJECTIVE	To undertake an economic evaluation alongside the largest randomised controlled trial comparing Levonorgestrel-releasing intrauterine device ( ` LNG-IUS ' ) and usual medical treatment for women with menorrhagia in primary care ; and compare the cost-effectiveness findings using two alternative measures of quality of life .
METHODS	571 women with menorrhagia from 63 UK centres were randomised between February 2005 and July 2009 .
METHODS	Women were randomised to having a LNG-IUS fitted , or usual medical treatment , after discussing with their general practitioner their contraceptive needs or desire to avoid hormonal treatment .
METHODS	The treatment was specified prior to randomisation .
METHODS	For the economic evaluation we developed a state transition ( Markov ) model with a 24 month follow-up .
METHODS	The model structure was informed by the trial women 's pathway and clinical experts .
METHODS	The economic evaluation adopted a UK National Health Service perspective and was based on an outcome of incremental cost per Quality Adjusted Life Year ( QALY ) estimated using both EQ-5D and SF-6D .
RESULTS	Using EQ-5D , LNG-IUS was the most cost-effective treatment for menorrhagia .
RESULTS	LNG-IUS costs 100 more than usual medical treatment but generated 0.07 more QALYs .
RESULTS	The incremental cost-effectiveness ratio for LNG-IUS compared to usual medical treatment was 1600 per additional QALY .
RESULTS	Using SF-6D , usual medical treatment was the most cost-effective treatment .
RESULTS	Usual medical treatment was both less costly ( 100 ) and generated 0.002 more QALYs .
CONCLUSIONS	Impact on quality of life is the primary indicator of treatment success in menorrhagia .
CONCLUSIONS	However , the most cost-effective treatment differs depending on the quality of life measure used to estimate the QALY .
CONCLUSIONS	Under UK guidelines LNG-IUS would be the recommended treatment for menorrhagia .
CONCLUSIONS	This study demonstrates that the appropriate valuation of outcomes in menorrhagia is crucial .

###24659208
OBJECTIVE	Hyperuricemia is a recognized risk factor for cardiovascular diseases .
OBJECTIVE	Soy foods contain a moderate amount of purine and may predispose to raised serum uric acid ( UA ) .
OBJECTIVE	However , no study has examined the long-term effect of soy intake on UA levels .
OBJECTIVE	We examined whether consumption of soy foods and isoflavone extracts for 6 months altered serum UA .
METHODS	The analysis included two randomized controlled trials ( soy protein trial and whole soy trial ) among total 450 postmenopausal women with either prehypertension or prediabetes .
METHODS	We conducted a pooled analysis by combining participants from both the soy flour and soy protein groups ( combined soy foods group ) , participants from both the isoflavone and daidzein groups ( combined isoflavone group ) and participants from both milk placebo groups .
METHODS	Fasting venous samples were obtained at baseline and the end of the trial for serum UA analysis .
RESULTS	In the pooled data , 417 subjects completed the study according to protocol .
RESULTS	The baseline serum UA levels were comparable among the three combined groups .
RESULTS	There was a lower decrease in UA levels among women in the combined soy foods group compared with women in the other two groups ( p = 0.028 and 0.026 ) .
RESULTS	The net decrease and % decrease in UA were 14.5 mol/L ( 95 % CI 1.93-25 .6 , p = 0.023 ) or 4.9 % ( 95 % CI 1.3-8 .5 % , p = 0.023 ) between the combined soy foods group and placebo group .
CONCLUSIONS	Among Chinese postmenopausal women with either prehypertension or prediabetes , soy intake did not increase urate levels .

###24885132
BACKGROUND	Surgical site infections are the most common hospital-acquired infections among surgical patients .
BACKGROUND	The administration of surgical antimicrobial prophylaxis reduces the risk of surgical site infections .
BACKGROUND	The optimal timing of this procedure is still a matter of debate .
BACKGROUND	While most studies suggest that it should be given as close to the incision time as possible , others conclude that this may be too late for optimal prevention of surgical site infections .
BACKGROUND	A large observational study suggests that surgical antimicrobial prophylaxis should be administered 74 to 30minutes before surgery .
BACKGROUND	The aim of this article is to report the design and protocol of a randomized controlled trial investigating the optimal timing of surgical antimicrobial prophylaxis .
METHODS	In this bi-center randomized controlled trial conducted at two tertiary referral centers in Switzerland , we plan to include 5,000 patients undergoing general , oncologic , vascular and orthopedic trauma procedures .
METHODS	Patients are randomized in a 1:1 ratio into two groups : one receiving surgical antimicrobial prophylaxis in the anesthesia room ( 75 to 30minutes before incision ) and the other receiving surgical antimicrobial prophylaxis in the operating room ( less than 30minutes before incision ) .
METHODS	We expect a significantly lower rate of surgical site infections with surgical antimicrobial prophylaxis administered more than 30minutes before the scheduled incision .
METHODS	The primary outcome is the occurrence of surgical site infections during a 30-day follow-up period ( one year with an implant in place ) .
METHODS	When assuming a 5 % surgical site infection risk with administration of surgical antimicrobial prophylaxis in the operating room , the planned sample size has an 80 % power to detect a relative risk reduction for surgical site infections of 33 % when administering surgical antimicrobial prophylaxis in the anesthesia room ( with a two-sided type I error of 5 % ) .
METHODS	We expect the study to be completed within three years .
CONCLUSIONS	The results of this randomized controlled trial will have an important impact on current international guidelines for infection control strategies in the hospital .
CONCLUSIONS	Moreover , the results of this randomized controlled trial are of significant interest for patient safety and healthcare economics .
BACKGROUND	This trial is registered on ClinicalTrials.gov under the identifier NCT01790529 .

###25138978
OBJECTIVE	Depression and anxiety are prevalent in patients with chronic pain and adversely affect pain , quality of life , and treatment response .
OBJECTIVE	The purpose of this psychometric study was to determine the reliability and validity of the four-item Patient Reported Outcomes Measurement Information System ( PROMIS ) depression and anxiety scales in patients with chronic pain .
METHODS	Secondary analysis of data from the Stepped Care to Optimize Pain care Effectiveness study , a randomized clinical trial of optimized analgesic therapy .
METHODS	Five primary care clinics at the Roudebush VA Medical Center ( RVAMC ) in Indianapolis , Indiana .
METHODS	Two hundred forty-four primary care patients with chronic musculoskeletal pain .
METHODS	All patients completed the four-item depression and anxiety scales from the PROMIS 29-item profile , as well as several other validated psychological measures .
METHODS	The minimally important difference ( MID ) using the standard error of measurement ( SEM ) was calculated for each scale , and convergent validity was assessed by interscale correlations at baseline and 3 months .
METHODS	Operating characteristics of the PROMIS measures for detecting patients who had probable major depression or were anxiety-disorder screen-positive were calculated .
RESULTS	The PROMIS scales had good internal reliability , and the MID ( as represented by two SEMs ) was 2 points for the depression scale and 2.5 points for the anxiety scale .
RESULTS	Convergent validity was supported by strong interscale correlations .
RESULTS	The optimal screening cutpoint on the 4 - to 20-point PROMIS scales appeared to be 8 for both the depression and anxiety scales .
CONCLUSIONS	The PROMIS four-item depression and anxiety scales are reasonable options as ultra-brief measures for screening in patients with chronic pain .

###24298897
OBJECTIVE	To investigate the association of radiographic progression defined by Prostate Cancer Working Group ( PCWG ) -2 guidelines and overall survival ( OS ) in men with metastatic castration-resistant prostate cancer ( mCRPC ) .
METHODS	Two trials that used PCWG-2 guidelines to define progression were analysed : a randomized phase II trial ( n = 221 ) comparing first-line docetaxel-prednisone plus AT-101 or placebo , and a phase III trial ( n = 873 ) comparing prednisone plus sunitinib or placebo after docetaxel-based chemotherapy .
METHODS	Cox proportional hazards regression models were used to estimate the association of radiographic progression with OS .
METHODS	Landmark analyses compared progressing patients with those who had not progressed .
METHODS	Sub-analyses compared patients removed from trial for progression vs other reasons .
RESULTS	An increased risk of death was seen for radiographic progression at landmark times from 6 to 12 months with docetaxel-based therapy ( hazard ratio [ HR ] > 1.7 at all time-points ) .
RESULTS	An increased risk of death was also seen with post-docetaxel prednisone alone or with sunitinib for progression at landmark times from 2 to 8 months ( HR > 2.7 at all time-points ) .
RESULTS	Kendall 's was 0.50 ( P < 0.001 ) in the setting of docetaxel-based therapy and 0.34 ( P < 0.001 ) in the post-docetaxel setting for association between radiographic progression and death amongst patients with both events .
RESULTS	Removal from study due to radiographic progression was associated with a significantly lower OS compared with removal for other reasons in both trials .
RESULTS	Limitations of a retrospective analysis apply and there was no central radiology review .
CONCLUSIONS	Radiographic progression by PCWG-2 criteria was significantly associated with OS in patients with mCRPC receiving first-line docetaxel-based chemotherapy or post-docetaxel therapy .
CONCLUSIONS	With external validation as a surrogate endpoint in trials showing survival benefits , the use of radiographic progression-free survival may expedite drug development in mCRPC , which has been hampered by the lack of intermediate endpoints .

###25189750
OBJECTIVE	This study aimed to develop a system for predicting work-related musculoskeletal disorders ( WMSD ) among dental students .
METHODS	The system comprised 2 accelerometer sensors to register neck and upper back postures and movements , and software developed to collect and process the data .
METHODS	Hidden Markov models ( HMMs ) were used to predict the likelihood of WMSD in dental students by comparing their neck and upper back movement patterns with WMSD and non-WMSD HMMs learned from previous data .
METHODS	To evaluate the performance of the system , 16 participants were randomly assigned into a 2 2 crossover trial scheduled for each sequence of working : receiving feedback or no-feedback from the system .
METHODS	The primary outcome measure was the extension of the neck and upper back , before ( pre-test ) and after ( posttest ) receiving feedback or no-feedback from the system .
METHODS	The secondary outcome measure was the log likelihood of classifying the movements as WMSD .
CONCLUSIONS	The results showed that in the group that received feedback , the extension of the neck in the y axis and of the upper back in the y axis decreased significantly ( t test , p < .05 ) on the post-test .
CONCLUSIONS	The system for predicting and preventing WMSD aids the correction of the extension of the neck and upper back in the y axis .

###25323094
OBJECTIVE	This exploratory study investigated whether integration of the Client Self-Care Commitment Model ( CSCCM ) Instructional Module in a dental hygiene curriculum , as an additional educational experience , would further enhance students ' client-centred knowledge , values and actions .
METHODS	Subjects ( n = 26 ) were second-year students enrolled in a BS entry-level dental hygiene programme with random assignments to two groups .
METHODS	The experimental group participated in a 2-h didactic session , an 8-h preclinical session , an 8-h clinical session and a 1-h question and answer period .
METHODS	An online pretest-post-test survey administered at three time intervals ( baseline , 3 and 6 weeks ) was used to measure differences between the groups on three subscales ( knowledge , values and actions ) .
RESULTS	Cronbach 's for each subscale across time was above 0.90 .
RESULTS	A repeated-measures anova determined that there were no statistically significant interactions between Time and Group ( experimental or control group ) for the knowledge and values variables ; however , there was a significant interaction between Time ( P = 0.003 ) and Group ( P = 0.033 ) for the actions variable .
RESULTS	A content analysis of participants ' responses to three open-ended questions reflected both positive and negative comments and revealed that students ' primary barrier to implementing the model in client care was lack of time .
CONCLUSIONS	Significant differences in the actions variable between the groups suggested that implementation of the CSCCM Instructional Module enhanced students ' client-centred actions during client care .

###25752740
BACKGROUND	To evaluate health related quality of life ( HRQOL ) in TEACH , a phase III randomized placebo controlled trial of 12 months of adjuvant lapatinib in HER2 positive ( HER2 + ) early breast cancer which demonstrated marginal benefit in disease-free survival .
METHODS	Women on TEACH completed the Short Form 36-item health survey ( version2 ; SF-36v2 ) at the baseline , six and 12 months after therapy initiation and six monthly thereafter .
METHODS	Mean changes were compared between treatment groups for two summary measures ( Physical and Mental Component Summary scores ; PCS and MCS ) and eight domain measures ( physical functioning , role physical , bodily pain , general health , vitality , social functioning , role emotional and mental health ) , and in patients discontinuing therapy .
METHODS	A five-point change was deemed a Minimally Clinically Important Difference ( MCID ) .
METHODS	Response analysis compared the proportion of patients demonstrating a MCID in HRQOL , and a regression analysis identified predictors of worsening HRQOL .
RESULTS	3074 ( 97 % ) subjects completed baseline SF-36v2 .
RESULTS	During the initial 12 months , summary SF-36v2 scores decreased in both arms but did not reach Minimally Clinically Important Difference ( MCID ) despite significant incidences of diarrhoea and rash in lapatinib treated patients .
RESULTS	At six months , women receiving lapatinib had more significant reductions ( p < 0.01 versus placebo ) in social functioning .
RESULTS	Early treatment discontinuations were more frequent on lapatinib ( 32 % versus 18 % ) , and were associated with more substantial decrements of HRQOL in both arms .
RESULTS	For those discontinuing primarily due to adverse events , decrements in HRQOL reached MCID in Mental Summary scores ( MCS ) only .
RESULTS	Lower baseline HRQOL was a significant predictor of worsening HRQOL ( p < 0.05 ) .
CONCLUSIONS	Despite frequent but usually mild toxicities , adjuvant lapatinib is not associated with clinically significant decreases in overall HRQOL .
CONCLUSIONS	These placebo-controlled results may also help to inform physicians and patients using lapatinib in metastatic HER2 positive breast cancer .
BACKGROUND	GlaxoSmithKline .
BACKGROUND	The AVON Foundation NY supported PEG , DF and BM and The Friends of the Mater Foundation supported FB .

###25030267
OBJECTIVE	Cerebrovascular anomalies resulting from the persistence of unfused embryonic twig-like vessels are associated with intracranial aneurysms .
OBJECTIVE	All records of patients with ruptured intracranial aneurysms who were treated at our institution were retrospectively reviewed for the presence of aneurysm-associated , unfused , twig-like vessels in the middle cerebral artery ( MCA ) .
OBJECTIVE	Such vessels were recorded as twig-like MCA ( T-MCA ) or twig-like networks of an anomalous collateral artery ( T-NACA ) .
OBJECTIVE	Additionally , we sought to characterize vulnerable intracranial aneurysms associated with those vascular anomalies .
METHODS	A total of 442 ruptured aneurysms were treated from June 2006 to November 2013 ; of these , 4 ruptured aneurysms exhibited the presence of ipsilateral , unfused , twig-like vessels .
METHODS	Computed tomography ( CT ) scans , three-dimensional CT angiography , and digital subtraction angiography ( DSA ) were performed immediately after the initial ictus .
METHODS	Data analysis included age , sex , Hunt and Hess grade ( HHG ) , Fisher grade ( FG ) , medical risk factors , angiographic architecture , operative methods and findings , radiologic outcomes , and Glasgow outcome scale ( GOS ) .
METHODS	The average follow-up period was 26 months .
RESULTS	Patient ages ranged from 26 to 49 years with a mean age of 41 ; there were two females and two males .
RESULTS	All four patients showed FG IV , and three patients had unfavorable HHG ( IV in 2 and V in one ) at admission .
RESULTS	An M1 segmental occlusion and an adjacent small aneurysmal pouch were detected with three-dimensional CT angiography in three patients .
RESULTS	Hypertension was recorded in all patients .
RESULTS	The initial DSA revealed T-MCA in one patient and T-NACA in three patients .
RESULTS	Six aneurysms in all , including two unruptured aneurysms , were found ; three ruptured aneurysms existed inside of the twigs .
RESULTS	All but one patient required diverse treatment modalities , and four of the five aneurysms were completely occluded after treatment .
RESULTS	The remaining aneurysm , treated only with gluing , disappeared during follow-up .
RESULTS	In two of the three patients with T-NACA , atresia of the M1 segment was confirmed intraoperatively .
RESULTS	The GOS during follow-up was recorded as favorable ( good recovery ) in two patients and unfavorable ( severe disability and permanent vegetative state ) in two patients .
CONCLUSIONS	These unique vascular anomalies , T-MCA and T-NACA , which are caused by heterogeneous maldevelopment of the primitive cerebral vessels , are not benign because of their frequent association with flow-related aneurysms , which are vulnerable to rupture .
CONCLUSIONS	Microsurgical or endovascular treatments for this type of flow-related aneurysm associated with twigs are mandatory to prevent fatal rebleeding , and more attention has to be given when physicians encounter steno-occlusive MCA lesions in patients with subarachnoid hemorrhage to detect any vulnerable aneurysms associated with twig-like vessels .

###25230216
OBJECTIVE	To evaluate the efficacy of memantine on metabolite levels in different areas of the brain and to determine whether changes in metabolite levels correlate with clinical variables in Fibromyalgia ( FM ) patients .
METHODS	Doubled-blind parallel randomized controlled trial .
METHODS	Twenty-five patients diagnosed with FM were enrolled in the study .
METHODS	Patients were administered questionnaires on pain , anxiety , depression , quality of life , and cognitive impairment , and single-voxel MRS of the brain was performed .
METHODS	All assessments were performed at baseline and after 6months of treatment with memantine or placebo .
RESULTS	Patients treated with memantine exhibited a significant increase in the glutamate ( P = 0.010 ) , glutamate/creatine ratio ( P = 0.013 ) , combined glutamate + glutamine ( P = 0.016 ) and total N-acetyl-aspartate ( NAA+NAAG ) ( P = 0.034 ) in the posterior cingulate cortex compared with those on placebo .
RESULTS	Furthermore , the memantine group exhibited increases in creatine ( P = 0.013 ) and choline ( Cho ) ( P = 0.025 ) in the right posterior insula and also a correlation between choline and the Fibromyalgia Impact Questionnaire ( FIQ ) in the posterior insula ( P = 0.050 ) was observed .
CONCLUSIONS	Memantine treatment resulted in an increase in cerebral metabolism in FM patients , suggesting its utility for the treatment of the illness .

###24310987
OBJECTIVE	The objective of this study was to evaluate the effect of vaginal packing following pelvic floor surgery with regard to post-operative pain , bleeding and infection .
OBJECTIVE	This was a double-blind randomised study of women undergoing vaginal hysterectomy and/or pelvic floor repair at a tertiary urogynaecology unit .
METHODS	The primary outcome of day 1 post-operative pain was assessed using the short-form McGill Pain score .
METHODS	Secondary outcomes were haematological and infective morbidity , evaluated using changes in full blood count , and cultures of midstream urine and high vaginal swabs .
METHODS	A transvaginal ultrasound scan to exclude pelvic haematoma was performed at 6 weeks in all women who underwent vaginal hysterectomy with or without a pelvic floor repair .
RESULTS	In total , 190 women were recruited : mean age 58.3 years ( 27-91 years ) , mean body mass index 27.4 kg/m ( 2 ) and median parity 3 .
RESULTS	Women were randomised into the ` pack ' ( n = 86 ) and ` no pack ' ( n = 87 ) arms with no demographic differences between the groups .
RESULTS	No statistically significant differences in the post-operative pain scores or secondary outcome measures were demonstrated .
RESULTS	Incidence of haematoma formation ( 14.8 % no pack , 7.3 % pack , p = 0.204 ) was not statistically significant .
RESULTS	There were three clinically significant complications in the no pack group and none in the pack group .
CONCLUSIONS	This is the first study to examine pain in association with post-operative vaginal packing .
CONCLUSIONS	There is no evidence to suggest that packing increases pain scores or post-operative morbidity .
CONCLUSIONS	A trend towards increased haematoma and significant complications was seen in the no pack group .
CONCLUSIONS	As vaginal packing does no harm and may be of some benefit it may be argued that packing should be recommended as routine clinical practice .

###24768130
BACKGROUND	Cognitive remediation ( CR ) aims primarily to improve cognition and functional outcomes .
BACKGROUND	However , a limited number of studies reported a positive effect on symptoms .
BACKGROUND	This limited effect may be because the symptom clusters considered are too broad and heterogeneous .
BACKGROUND	This study explores , for the first time , the effect of CR on five empirically defined symptom dimensions of schizophrenia .
METHODS	Participants were patients with schizophrenia taking part in a randomised controlled trial comparing CR plus treatment as usual ( CR , N = 43 ) to treatment as usual ( TAU , N = 42 ) .
METHODS	All participants were assessed at baseline and 14-weeks ( i.e. at the conclusion of treatment for the CR group ) with the Positive and Negative Symptoms Scale ( PANSS ) .
METHODS	Five symptom dimensions were derived from the PANSS scores : Positive ( POS ) , Negative ( NEG ) , Disorganised ( DIS ) , Excited ( EXC ) and Emotional Distressed ( EMD ) .
RESULTS	After CR , the therapy group had a significant reduction in DIS and NEG symptom dimensions compared to the TAU group .
RESULTS	The traditional PANSS factors showed no effect of CR on symptoms .
CONCLUSIONS	CR can have not only a positive effect on disorganisation but also on negative symptoms .
CONCLUSIONS	Using detailed symptom dimensions can characterise more accurately the effect of CR on symptom of schizophrenia .

###24402587
OBJECTIVE	To increase access to early second-trimester surgical abortion by determining noninferiority of same-day synthetic osmotic dilators compared with overnight Laminaria for cervical preparation before early second-trimester dilation and evacuation .
METHODS	We enrolled women between 14 and 18 weeks of gestation and randomized them to same-day synthetic osmotic dilators or overnight Laminaria .
METHODS	Study participants and clinicians were blinded to group assignment .
METHODS	The primary outcome was procedure duration .
METHODS	The trial was powered to assess noninferiority of synthetic osmotic dilators to exclude a mean difference of 5 minutes or longer .
RESULTS	We enrolled 72 patients : 36 were randomized to same-day synthetic osmotic dilators and 36 to overnight Laminaria .
RESULTS	Mean procedure duration was 8.1 and 5.9 minutes , respectively , with a mean difference of 2.1 minutes ( 97.5 % confidence interval -0.3 to 4.5 ) .
RESULTS	Same-day synthetic osmotic dilators resulted in less initial cervical dilation than overnight Laminaria ( mean circumference 48 compared with 60 mm Pratt , P < .001 ) and required more mechanical dilation ( 69 % compared with 27 % , P = .001 ) .
RESULTS	There was no difference in complications , all of which were minor , or in the median procedural difficulty score rated by physicians .
RESULTS	Most patients in both groups would choose a same-day procedure if necessary in the future .
CONCLUSIONS	Despite less initial cervical dilation and a greater need for mechanical dilation , same-day synthetic osmotic dilators are not inferior to overnight Laminaria with respect to procedure duration .
CONCLUSIONS	Same-day osmotic dilation is preferred by patients and may be a reasonable alternative to overnight Laminaria for cervical preparation before early second-trimester dilation and evacuation .
BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT00775983 .
METHODS	I.

###24470706
OBJECTIVE	Obstructive sleep apnea ( OSA ) , common in Parkinson disease ( PD ) , contributes to sleep disturbances and daytime sleepiness .
OBJECTIVE	We assessed the effect of continuous positive airway pressure ( CPAP ) on OSA , sleep , and daytime sleepiness in patients with PD .
METHODS	This was a randomized placebo-controlled , crossover design .
METHODS	Patients with PD and OSA were randomized into 6 w of therapeutic treatment or 3 w of placebo followed by 3 w of therapeutic treatment .
METHODS	Patients were evaluated by polysomnography ( PSG ) and multiple sleep latency test ( MSLT ) pretreatment ( baseline ) , after 3 w , and after 6 w of CPAP treatment .
METHODS	Analyses included mixed models , paired analysis , and within-group analyses comparing 3 w to 6 w of treatment .
METHODS	Sleep laboratory .
METHODS	Thirty-eight patients with PD ( mean age = 67.2 9.2 y ; 12 females ) .
METHODS	Continuous positive airway pressure .
METHODS	PSG OUTCOME MEASURES : sleep efficiency , % sleep stages ( N1 , N2 , N3 , R ) , arousal index , apnea-hypopnea index ( AHI ) , and % time oxygen saturation < 90 % ( % time SaO2 < 90 % ) .
METHODS	MSLT outcome measures : mean sleep-onset latency ( MSL ) .
RESULTS	There were significant group-by-time interactions for AHI ( P < 0.001 ) , % time SaO2 < 90 % ( P = 0.02 ) , % N2 ( P = 0.015 ) and % N3 ( P = 0.014 ) .
RESULTS	Subjects receiving therapeutic CPAP showed significant decrease in AHI , % time SaO2 < 90 % , % N2 , and significant increase in % N3 indicating effectiveness of CPAP in the treatment of OSA , improvement in nighttime oxygenation , and in deepening sleep .
RESULTS	The paired sample analyses revealed that 3 w of therapeutic treatment resulted in significant decreases in arousal index ( t = 3.4 , P = 0.002 ) .
RESULTS	All improvements after 3 w were maintained at 6 w. Finally , 3 w of therapeutic CPAP also resulted in overall decreases in daytime sleepiness ( P = 0.011 ) .
CONCLUSIONS	Therapeutic continuous positive airway pressure versus placebo was effective in reducing apnea events , improving oxygen saturation , and deepening sleep in patients with Parkinson disease and obstructive sleep apnea .
CONCLUSIONS	Additionally , arousal index was reduced and effects were maintained at 6 weeks .
CONCLUSIONS	Finally , 3 weeks of continuous positive airway pressure treatment resulted in reduced daytime sleepiness measured by multiple sleep latency test .
CONCLUSIONS	These results emphasize the importance of identifying and treating obstructive sleep apnea in patients with Parkinson disease .

###24990101
OBJECTIVE	Simple aeration of food matrices with gas has previously been shown to generate immediate suppression of appetite , though duration of effects has not been shown .
OBJECTIVE	This research tested whether liquids aerated with nitrous oxide ( N2 O ) to achieve high in-body stability could produce enhanced and sustained effects on eating motivations .
METHODS	In two randomized cross-over studies , appetite ratings were collected for 240 min .
METHODS	In Study 1 , 24 volunteers consumed a full portion liquid ( 325 ml , 190 kcal ) or aerated ( 1,000 ml , 190 kcal ) drink at 0 min , or half portions of liquid ( 162 ml , 95 kcal ) or aerated ( 500 ml , 95 kcal ) drink at 0 and 120 min .
METHODS	In Study 2 , assessing the effect of N2 O itself , 23 volunteers consumed water saturated with N2 O or with CO2 10 min after a mini-drink ( 180 kcal ) .
METHODS	Appetite was quantified by area-under-the curve ( AUC ) and time-to-return-to-baseline ( TTRTB ) .
RESULTS	Full - and half-size aerated drinks decreased hunger AUC over 4 h by 26 and 50 % ( P < 0.0001 ) versus the respective liquid versions .
RESULTS	Effects were also sustained significantly longer ( TTRTB from 203 to 335 and from 173 to 286 min , respectively ) .
RESULTS	In Study 2 , N2 O and CO2 had similar effects on appetite ratings .
CONCLUSIONS	Aeration of foods using appropriate microstructural design has a powerful effect on eating motivations .

###24410739
BACKGROUND	Hypo-fractionated external beam radiotherapy with narrow CTV-PTV margins is increasingly applied for prostate cancer .
BACKGROUND	This demands a precise target definition and knowledge on target location and extension during treatment .
BACKGROUND	It is unclear how increase in fraction size affects changes in prostate volume during treatment .
BACKGROUND	Our aim was to study prostate volume changes during extreme hypo-fractionation ( 7 6.1 Gy ) by using sequential MRIs .
METHODS	Twenty patients treated with extreme hypo-fractionation were recruited from an on-going prospective randomized phase III trial .
METHODS	An MRI scan was done before start of treatment , at mid treatment and at the end of radiotherapy .
METHODS	The prostate was delineated at each MRI and the volume and maximum extension in left-right , anterior-posterior and cranial-caudal directions were measured .
RESULTS	There was a significant increase in mean prostate volume ( 14 % ) at mid treatment as compared to baseline .
RESULTS	The prostate volume remained enlarged ( 9 % ) at the end of radiotherapy .
RESULTS	Prostate swelling was most pronounced in the anterior-posterior and cranial-caudal directions .
CONCLUSIONS	Extreme hypo-fractionation induced a significant prostate swelling during treatment that was still present at the time of last treatment fraction .
CONCLUSIONS	Our results indicate that prostate swelling is an important factor to take into account when applying treatment margins during short extreme hypo-fractionation , and that tight margins should be applied with caution .

###24590635
OBJECTIVE	This is a randomized , double-blind , placebo-controlled study aimed to evaluate the clinical and biologic effects of letrozole plus lapatinib or placebo as neoadjuvant therapy in hormone receptor ( HR ) - positive/human epidermal growth factor receptor 2 ( HER2 ) - negative operable breast cancer .
METHODS	Ninety-two postmenopausal women with stage II to IIIA primary breast cancer were randomly assigned to preoperative therapy consisting of 6 months of letrozole 2.5 mg orally daily plus lapatinib 1,500 mg orally daily or placebo .
METHODS	Surgery was performed within 2 weeks from the last study medication .
METHODS	Clinical response was assessed by ultrasonography .
METHODS	Pre - and post-treatment samples were evaluated for selected biomarkers .
METHODS	Fresh-frozen tissue samples were collected for genomic analyses .
RESULTS	Numerically similar clinical response rates ( partial + complete response ) were observed ( 70 % for letrozole-lapatinib and 63 % for letrozole-placebo ) .
RESULTS	Toxicities were generally mild and manageable .
RESULTS	A significant decrease in Ki-67 and pAKT expression from baseline to surgery was observed in both arms .
RESULTS	Overall , 34 patients ( 37 % ) had a mutation in PIK3CA exon 9 or 20 .
RESULTS	In the letrozole-lapatinib arm , the probability of achieving a clinical response was significantly higher in the presence of PIK3CA mutation ( objective response rate , 93 % v 63 % in PIK3CA wild type ; P = .040 ) .
CONCLUSIONS	The combination of letrozole-lapatinib in early breast cancer was feasible , with expected and manageable toxicities .
CONCLUSIONS	In unselected estrogen receptor-positive/HER2-negative patients , letrozole-lapatinib and letrozole-placebo resulted in a similar overall clinical response rate and similar effect on Ki-67 and pAKT .
CONCLUSIONS	Our secondary end point findings of a significant correlation between PIK3CA mutation and response to letrozole-lapatinib in HR-positive/HER2-negative early breast cancer must now be independently confirmed .

###24918629
BACKGROUND	To study the effects of low tidal volume with positive end-expiratory pressure ( PEEP ) on arterial blood gases of patients undergoing laparoscopic urologic surgeries .
METHODS	Eighty-six laparoscopic urologic patients were enrolled in this study .
METHODS	Patients were randomized into two groups according to the ventilatory settings .
METHODS	In the conventional group ( Group C ) ( n = 43 ) , the tidal volume was 10mL/kg , and the PEEP was set at 0cm of H2O .
METHODS	In the low tidal volume with PEEP group ( Group LP ) , the tidal volume was 6mL/kg , with PEEP of 5cm of H2O .
METHODS	In both groups total minute volume was 6 L/kg .
METHODS	Peak and plateau airway pressure ( PPEAK and PPLAT , respectively ) and arterial blood gases were recorded before pneumoperitoneum ( PNP ) ( T1 ) and the first and third hour ( T3 ) after PNP induction and also after extubation in the intensive care unit .
METHODS	Additionally , heart rate , mean arterial pressure , and peripheral O2 saturation of hemoglobin were recorded .
RESULTS	Heart rate , PPEAK , and PPLAT values were similar in both groups .
RESULTS	Partial arterial O2 pressure values measured postoperatively were significantly higher in Group LP , whereas those measured before PNP induction were similar ( P = .014 and P = .056 , respectively ) .
RESULTS	Compared with the baseline , partial arterial CO2 pressure values measured at T1 and at T3 after PNP induction were significantly higher in Group C than in Group LP ( P < .001 ) .
RESULTS	The pH values of Group C at T1 and at T3 postoperatively were significantly lower than the values of Group LP ( P < .001 ) .
RESULTS	Extubation times were significantly lower in Group LP .
CONCLUSIONS	The results of the present study suggest that low tidal volume with PEEP application may be a good alternative for preventing high CO2 levels and yielding better oxygenation and lower extubation times in patients undergoing prolonged laparoscopic urology .

###25122671
BACKGROUND	Masitinib is a highly selective tyrosine kinase inhibitor with activity against the main oncogenic drivers of gastrointestinal stromal tumor ( GIST ) .
BACKGROUND	Masitinib was evaluated in patients with advanced GIST after imatinib failure or intolerance .
METHODS	Prospective , multicenter , randomized , open-label trial .
METHODS	Patients with inoperable , advanced imatinib-resistant GIST were randomized ( 1 : 1 ) to receive masitinib ( 12 mg/kg/day ) or sunitinib ( 50 mg/day 4-weeks-on/2-weeks-off ) until progression , intolerance , or refusal .
METHODS	Primary efficacy analysis was noncomparative , testing whether masitinib attained a median progression-free survival ( PFS ) ( blind centrally reviewed RECIST ) threshold of > 3 months according to the lower bound of the 90 % unilateral confidence interval ( CI ) .
METHODS	Secondary analyses on overall survival ( OS ) and PFS were comparative with results presented according to a two-sided 95 % CI .
RESULTS	Forty-four patients were randomized to receive masitinib ( n = 23 ) or sunitinib ( n = 21 ) .
RESULTS	Median follow-up was 14 months .
RESULTS	Patients receiving masitinib experienced less toxicity than those receiving sunitinib , with significantly lower occurrence of severe adverse events ( 52 % versus 91 % , respectively , P = 0.008 ) .
RESULTS	Median PFS ( central RECIST ) for the noncomparative primary analysis in the masitinib treatment arm was 3.71 months ( 90 % CI 3.65 ) .
RESULTS	Secondary analyses showed that median OS was significantly longer for patients receiving masitinib followed by post-progression addition of sunitinib when compared against patients treated directly with sunitinib in second-line [ hazard ratio ( HR ) = 0.27 , 95 % CI 0.09-0 .85 , P = 0.016 ] .
RESULTS	This improvement was sustainable as evidenced by 26-month follow-up OS data ( HR = 0.40 , 95 % CI 0.16-0 .96 , P = 0.033 ) ; an additional 12.4 months survival advantage being reported for the masitinib treatment arm .
RESULTS	Risk of progression while under treatment with masitinib was in the same range as for sunitinib ( HR = 1.1 , 95 % CI 0.6-2 .2 , P = 0.833 ) .
CONCLUSIONS	Primary efficacy analysis ensured the masitinib treatment arm could satisfy a prespecified PFS threshold .
CONCLUSIONS	Secondary efficacy analysis showed that masitinib followed by the standard of care generated a statistically significant survival benefit over standard of care .
CONCLUSIONS	Encouraging median OS and safety data from this well-controlled and appropriately designed randomized trial indicate a positive benefit-risk ratio .
CONCLUSIONS	Further development of masitinib in imatinib-resistant/intolerant patients with advanced GIST is warranted .

###24231837
OBJECTIVE	We evaluated the efficacy and safety of a once monthly oxybutynin vaginal ring in women with overactive bladder .
METHODS	This randomized , multicenter , double-blind , 12-week phase 2 study compared oxybutynin vaginal ring ( 4 or 6 mg daily ) to a placebo vaginal ring in women with well-defined overactive bladder symptoms .
METHODS	The primary efficacy variable was the change from baseline to week 12 in the total weekly number of incontinence episodes ( stress and urge ) .
METHODS	Safety was measured in terms of treatment emergent adverse events , laboratory , physical , gynecologic examinations , electrocardiogram and vital signs .
RESULTS	After a 3-week post-randomization placebo run-in phase ( sample size 720 ) 445 women entered the treatment phase ( safety population ) .
RESULTS	Of these women 323 met all 3 overactive bladder specific baseline characteristics of 10 or more urinary urge incontinence episodes weekly , urinary frequency 8 or more voids per 24 hours and voided volume 3 L or less per 24 hours ) ( analysis population ) .
RESULTS	Women treated with 4 and 6 mg daily oxybutynin vaginal ring had significantly fewer incontinence episodes weekly ( p = 0.036 and p = 0.018 , respectively ) , lower daily urinary frequency ( p = 0.014 , p = 0.002 ) and a higher proportion had no incontinence episodes at week 12 ( p = 0.026 , p = 0.027 ) compared with placebo .
RESULTS	The change in severity of urgency and voided volume was similar for all groups ( p > 0.05 ) .
RESULTS	Except for a higher incidence of dry mouth and urinary tract infections that were not always culture confirmed , the oxybutynin vaginal ring was well tolerated and had a safety profile similar to that of the placebo vaginal ring .
CONCLUSIONS	The oxybutynin vaginal ring appears to be an effective and safe once monthly treatment option for women with overactive bladder characterized primarily by urinary urge incontinence that merits further evaluation in a phase 3 study .

###24423370
BACKGROUND	The Portuguese National Health Directorate has issued clinical practice guidelines on prescription of anti-inflammatory drugs , acid suppressive therapy , and antiplatelets .
BACKGROUND	However , their effectiveness in changing actual practice is unknown .
METHODS	The study will compare the effectiveness of educational outreach visits regarding the improvement of compliance with clinical guidelines in primary care against usual dissemination strategies .
METHODS	A cost-benefit analysis will also be conducted .
METHODS	We will carry out a parallel , open , superiority , randomized trial directed to primary care physicians .
METHODS	Physicians will be recruited and allocated at a cluster-level ( primary care unit ) by minimization .
METHODS	Data will be analyzed at the physician level .
METHODS	Primary care units will be eligible if they use electronic prescribing and have at least four physicians willing to participate .
METHODS	Physicians in intervention units will be offered individual educational outreach visits ( one for each guideline ) at their workplace during a six-month period .
METHODS	Physicians in the control group will be offered a single unrelated group training session .
METHODS	Primary outcomes will be the proportion of cyclooxygenase-2 inhibitors prescribed in the anti-inflammatory class , and the proportion of omeprazole in the proton pump inhibitors class at 18 months post-intervention .
METHODS	Prescription data will be collected from the regional pharmacy claims database .
METHODS	We estimated a sample size of 110 physicians in each group , corresponding to 19 clusters with a mean size of 6 physicians .
METHODS	Outcome collection and data analysis will be blinded to allocation , but due to the nature of the intervention , physicians and detailers can not be blinded .
CONCLUSIONS	This trial will attempt to address unresolved issues in the literature , namely , long term persistence of effect , the importance of sequential visits in an outreach program , and cost issues .
CONCLUSIONS	If successful , this trial may be the cornerstone for deploying large scale educational outreach programs within the Portuguese National Health Service .
BACKGROUND	ClinicalTrials.gov number NCT01984034 .

###25539518
OBJECTIVE	Few studies have compared the effect of Web-based eLearning versus small-group learning on medical student outcomes .
OBJECTIVE	Palliative and end-of-life ( PEOL ) education is ideal for this comparison , given uneven access to PEOL experts and content nationally .
METHODS	In 2010 , the authors enrolled all third-year medical students at the University of California , Davis School of Medicine into a quasi-randomized controlled trial of Web-based interactive education ( eDoctoring ) compared with small-group education ( Doctoring ) on PEOL clinical content over two months .
METHODS	Students participated in three 3-hour PEOL sessions with similar content .
METHODS	Outcomes included a 24-item PEOL-specific self-efficacy scale with three domains ( diagnosis/treatment [ Cronbach alpha = 0.92 ; CI : 0.91-0 .93 ] , communication/prognosis [ alpha = 0.95 ; CI : 0.93-0 .96 ] , and social impact/self-care [ alpha = 0.91 ; CI : 0.88-0 .92 ] ) ; 8 knowledge items ; 10 curricular advantage/disadvantages ; and curricular satisfaction ( both students and faculty ) .
RESULTS	Students were randomly assigned to Web-based eDoctoring ( n = 48 ) or small-group Doctoring ( n = 71 ) curricula .
RESULTS	Self-efficacy and knowledge improved equivalently between groups ( e.g. , prognosis self-efficacy , 19 % ; knowledge , 10 % -42 % ) .
RESULTS	Student and faculty ratings of the Web-based eDoctoring curriculum and the small-group Doctoring curriculum were equivalent for most goals , and overall satisfaction was equivalent for each , with a trend toward decreased eDoctoring student satisfaction .
CONCLUSIONS	Findings showed equivalent gains in self-efficacy and knowledge between students participating in a Web-based PEOL curriculum in comparison with students learning similar content in a small-group format .
CONCLUSIONS	Web-based curricula can standardize content presentation when local teaching expertise is limited , but it may lead to decreased user satisfaction .

###25171799
OBJECTIVE	We hypothesized that novices would be able to use the McGrath MAC ( Aircraft Medical Ltd , Edinburgh , UK ) equally as well as the GlideScope Ranger ( Verathon , Inc , Bothell , WA ) for intubation in regular simulated airways .
METHODS	We performed a prospective , randomized crossover study of 39 medical students using the McGrath MAC , GlideScope Ranger , and Macintosh in a manikin with 2 normal airways .
METHODS	The primary outcome was the intubation time .
METHODS	Secondary outcomes included the success rates and the overall glottic view of the 3 laryngoscopes .
RESULTS	The mean intubation times for each attempt with the McGrath MAC were 30.8 16.9 seconds or less and did not differ significantly from those obtained with the GlideScope Ranger or the Macintosh in both airway scenarios ( P = .18 ; P = .49 ) .
RESULTS	The mean success rates at each attempt with the McGrath MAC were 82.0 % 38.8 % or more , equal to the Macintosh and the GlideScope Ranger in both scenarios ( P = .026 ; P = .72 ) except during the first intubation attempt in a normal airway ( P = .008 ) .
RESULTS	The median grades of the glottic view visible at each intubation attempt with the McGrath Mac were Cormack-Lehane grade 1 ( scenario 1 : interquartile range , 1-1 ; scenario 2 : interquartile range , 1-2 ) , which was significantly better than the Macintosh laryngoscope in both scenarios .
RESULTS	However , the McGrath Mac did not produce a better glottic view than the GlideScope Ranger with either scenario .
CONCLUSIONS	The intubation performance of novices using the McGrath MAC was equal to their performance using the GlideScope Ranger in regular simulated airways .

###25350855
BACKGROUND	Complications are a common and accepted risk of surgery .
BACKGROUND	Failure to optimize the management of patients who suffer postoperative morbidity may result in poorer surgical outcomes .
BACKGROUND	This study aimed to evaluate a checklist-based tool to improve and standardize care of postoperative complications .
METHODS	Surgical trainees conducted baseline ward rounds of three patients with common postoperative complications in a high-fidelity simulated ward environment .
METHODS	Subjects were randomized to intervention or control groups , and final ward rounds were conducted with or without the aid of checklists for management of postoperative complications .
METHODS	Adherence to critical care processes was assessed , in addition to technical ( Surgical Ward-care Assessment Tool , SWAT ) and non-technical ( Ward NOn-TECHnical Skills ( W-NOTECHS ) scale ) performance .
METHODS	Subjects completed a feedback questionnaire regarding their perception of the checklists .
RESULTS	Twenty trainees completed 120 patient assessments .
RESULTS	All intervention group subjects opted to use the checklists , resulting in significantly fewer critical errors compared with controls ( median ( i.q.r. ) 0 ( 0-0 ) versus 60 ( 40-73 ) per cent ; P < 0001 ) .
RESULTS	The intervention group demonstrated improved patient management ( SWAT-M ) ( P < 0001 ) and non-technical skills ( P = 0043 ) between baseline and final ward rounds , whereas controls did not ( P = 0571 and P = 0809 respectively ) .
RESULTS	A small learning effect was seen with improvement in patient assessment ( SWAT-A ) in both groups ( P < 0001 ) .
RESULTS	Intervention group subjects found checklists easy and effective to use , and would want them used for their own care if they were to experience postoperative complications .
CONCLUSIONS	Checklist use resulted in significantly improved standardization , evidence-based management of postoperative complications , and quality of ward rounds .
CONCLUSIONS	Simulation-based piloting aided appropriate use of checklists and staff engagement .
CONCLUSIONS	Checklists represent a low-cost intervention to reduce rates of failure to rescue and to improve patient care .

###24395288
BACKGROUND	We sought to improve lumbar spine bone mineral density ( LS-BMD ) in long-term survivors of childhood acute lymphoblastic leukemia ( ALL ) using calcium and cholecalciferol supplementation .
METHODS	This double-blind , placebo-controlled trial randomized 275 participants ( median age , 17 [ 9-36 .1 ] years ) with age - and gender-specific LS-BMD Z-scores < 0 to receive nutritional counseling with supplementation of 1,000 mg/day calcium and 800 International Unit cholecalciferol or placebo for 2 years .
METHODS	The primary outcome was change in LS-BMD assessed by quantitative computerized tomography ( QCT ) at 24 months .
METHODS	Linear regression models were employed to identify the baseline risk factors for low LS-BMD and to compare LS-BMD outcomes .
RESULTS	Pre-randomization LS-BMD below the mean was associated with male gender ( P = 0.0024 ) , White race ( P = 0.0003 ) , lower body mass index ( P < 0.0001 ) , and cumulative glucocorticoid doses of 5,000 mg ( P = 0.0012 ) .
RESULTS	One hundred eighty-eight ( 68 % ) participants completed the study ; 77 % adhered to the intervention .
RESULTS	Mean LS-BMD change did not differ between survivors randomized to supplements ( 0.33 0.57 ) or placebo ( 0.28 0.56 ) .
RESULTS	Participants aged 9-13 years and those 22-35 years had the greatest mean increases in LS-BMD ( 0.50 0.66 and 0.37 0.23 , respectively ) .
RESULTS	Vitamin D insufficiency ( serum 25 [ OH ] D < 30 ng/ml ) found in 296 ( 75 % ) , was not associated with LS-BMD outcomes ( P = 0.78 ) .
CONCLUSIONS	Cholecalciferol and calcium supplementation provides no added benefit to nutritional counseling for improving LS-BMD among adolescent and young adult survivors of ALL ( 93 % of whom had LS-BMD Z-scores above the mean at study entry ) .

###25531240
OBJECTIVE	Strategies for oxygen therapy for preterm infants , such as the Vermont-Oxford 's ` Breathsavers ' guidelines , seek to strike a balance between the potential risks of the extremes of hyperoxia and hypoxia in preterm infants .
OBJECTIVE	Using an algorithm based on those guidelines , we aimed to compare the proportion of time spent within the SpO2 target range during algorithm-based management of oxygen delivery compared with routine nursing care .
METHODS	In a randomised crossover trial , maintenance of SpO2 over a 4-hour period during routine care was compared with algorithm-based control ( administered by a dedicated research nurse ) .
METHODS	SpO2 target ( 88-92 % ) and alarm limits ( 86-94 % ) were identical in both arms .
METHODS	Infants < 32 weeks ' gestation were eligible if having > 8 desaturations episodes to < 85 % / 4 h while receiving continuous positive airway pressure/synchronised intermittent mandatory ventilation .
METHODS	Data was recorded via the Powerlab system from Masimo oximeters and Babylog 8000 + ventilators .
RESULTS	16 infants with a gestation of 26.7 1.3 weeks ( mean SD ) and birth weight 901 193 g were studied at a postmenstrual age of 30.5 2.4 weeks .
RESULTS	The percentage of time spent within target range was 34.6 28.5 % during routine care versus 38.3 29.3 % during algorithm-based care ( p = 0.23 ) .
RESULTS	Compliance with alarm limits was 58.4 21.8 % during routine versus 64.7 22.1 % for algorithm-based care ( p = 0.091 ) .
RESULTS	The frequency of desaturations , episode severity or number of FiO2 adjustments did not differ between the two care strategies .
CONCLUSIONS	The observation that algorithm-based control did not improve time spent within the SpO2 target and alarm limits suggests nursing care has reached an optimum in the unit studied .
CONCLUSIONS	Our finding indicates that significant modifications to the algorithm are likely to be necessary to improve target range compliance .

###25045257
BACKGROUND	After a hip fracture , a catabolic state develops , with increased bone loss during the first year .
BACKGROUND	The aim of this study was to evaluate the effects of postoperative treatment with calcium , vitamin D , and bisphosphonates ( alone or together ) with nutritional supplementation on total hip and total body bone mineral density ( BMD ) .
METHODS	Seventy-nine patients ( 56 women ) , with a mean age of 79 years ( range , 61-96 years ) and with a recent hip fracture , who were ambulatory before fracture and without severe cognitive impairment , were included .
METHODS	Patients were randomized to treatment with bisphosphonates ( risedronate 35 mg weekly ) for 12 months ( B ; n = 28 ) , treatment with bisphosphonates along with nutritional supplementation ( 40 g protein , 600 kcal daily ) for the first 6 months ( BN ; n = 26 ) , or to controls ( C ; n = 25 ) .
METHODS	All participants received calcium ( 1,000 mg ) and vitamin D3 ( 800 IU ) daily .
METHODS	Total hip and total body BMD were assessed with dual-energy X-ray absorptiometry at baseline , 6 , and 12 months .
METHODS	Marker of bone resorption C-terminal telopeptide of collagen I and 25-hydroxy vitamin D were analyzed in serum .
RESULTS	Analysis of complete cases ( 70/79 at 6 months and 67/79 at 12 months ) showed an increase in total hip BMD of 0.7 % in the BN group , whereas the B and C groups lost 1.1 % and 2.4 % of BMD , respectively , between baseline and 6 months ( P = 0.071 , between groups ) .
RESULTS	There was no change in total body BMD between baseline and 12 months in the BN group , whereas the B group and C group both lost BMD , with C losing more than B ( P = 0.009 ) .
RESULTS	Intention-to-treat analysis was in concordance with the complete cases analyses .
CONCLUSIONS	Protein-and energy-rich supplementation in addition to calcium , vitamin D , and bisphosphonate therapy had additive effects on total body BMD and total hip BMD among elderly hip fracture patients .

###24856748
BACKGROUND	Ten percent of the time , peripheral intravenous access ( PIV ) is not obtained in 2 attempts in the emergency department .
BACKGROUND	Typically , a tourniquet is used to dilate the target vein ; but recent research showed that a blood pressure ( BP ) cuff improves dilation , which may translate to increased PIV success .
OBJECTIVE	We sought to determine if there is improved success in obtaining ultrasound-guided PIV using a BP cuff vs a tourniquet in `` difficult stick '' patients .
METHODS	This is a prospective , randomized , single-blinded trial .
METHODS	Adult patients requiring PIV with at least 2 prior failed attempts were enrolled .
METHODS	Patients were assigned to tourniquet or BP cuff for target vein dilation randomly .
METHODS	Nurses prepared the patient for PIV attempt by either placing a BP cuff inflated to 150 mm Hg or placing a tourniquet on the chosen extremity .
METHODS	The extremity was draped to blind the physician to assignment .
METHODS	Physicians then attempted ultrasound-guided PIV .
METHODS	Failures were defined as IVs requiring greater than 3 ultrasound-guided attempts or 30 minutes , or patient intolerance .
METHODS	If failure occurred , the physician was unblinded ; and the patient could be crossed over and reattempted .
RESULTS	Thirty-eight patients were enrolled .
RESULTS	The success rate for the tourniquet group ( n = 17 ) and BP cuff group ( n = 21 ) was 82.4 % and 47.6 % , respectively ( P = .04 ) .
RESULTS	There were no differences between groups for vessel depth , diameter , or procedure time .
RESULTS	Six in the BP cuff group were crossed over and had successful PIV obtained with tourniquet .
CONCLUSIONS	Tourniquet is superior to BP cuff for target vein dilation in ultrasound-guided PIV .

###24879836
OBJECTIVE	To compare the efficacy and safety of dulaglutide , a once-weekly GLP-1 receptor agonist , with placebo and exenatide in type 2 diabetic patients .
OBJECTIVE	The primary objective was to determine superiority of dulaglutide 1.5 mg versus placebo in HbA1c change at 26 weeks .
METHODS	This 52-week , multicenter , parallel-arm study ( primary end point : 26 weeks ) randomized patients ( 2:2:2:1 ) to dulaglutide 1.5 mg , dulaglutide 0.75 mg , exenatide 10 g , or placebo ( placebo-controlled period : 26 weeks ) .
METHODS	Patients were treated with metformin ( 1,500-3 ,000 mg ) and pioglitazone ( 30-45 mg ) .
METHODS	Mean baseline HbA1c was 8.1 % ( 65 mmol/mol ) .
RESULTS	Least squares mean SE HbA1c change from baseline to the primary end point was -1.51 0.06 % ( -16.5 0.7 mmol/mol ) for dulaglutide 1.5 mg , -1.30 0.06 % ( -14.2 0.7 mmol/mol ) for dulaglutide 0.75 mg , -0.99 0.06 % ( -10.8 0.7 mmol/mol ) for exenatide , and -0.46 0.08 % ( -5.0 0.9 mmol/mol ) for placebo .
RESULTS	Both dulaglutide doses were superior to placebo at 26 weeks ( both adjusted one-sided P < 0.001 ) and exenatide at 26 and 52 weeks ( both adjusted one-sided P < 0.001 ) .
RESULTS	Greater percentages of patients reached HbA1c targets with dulaglutide 1.5 mg and 0.75 mg than with placebo and exenatide ( all P < 0.001 ) .
RESULTS	At 26 and 52 weeks , total hypoglycemia incidence was lower in patients receiving dulaglutide 1.5 mg than in those receiving exenatide ; no dulaglutide-treated patients reported severe hypoglycemia .
RESULTS	The most common gastrointestinal adverse events for dulaglutide were nausea , vomiting , and diarrhea .
RESULTS	Events were mostly mild to moderate and transient .
CONCLUSIONS	Both once-weekly dulaglutide doses demonstrated superior glycemic control versus placebo and exenatide with an acceptable tolerability and safety profile .

###25140981
BACKGROUND	Alcohol accelerates the course of hepatitis C ( HCV ) infection and liver damage .
BACKGROUND	Little is known about recency of alcohol use among patients with HCV .
OBJECTIVE	Alcohol consumption recency was compared among HCV patients with and without alcohol use disorders and current and lifetime alcohol use histories .
METHODS	Patients considering antiviral treatment for HCV ( n = 309 ) recruited from university-affiliated and VA liver and infectious disease clinics were assessed for lifetime and current-year psychiatric disorders and alcohol-use patterns .
METHODS	Full diagnostic interviews , self-report surveys , medical record review , and urine screening for recent alcohol and drug use were conducted .
RESULTS	60 % used alcohol in the last year .
RESULTS	Besides alcohol history , those who stopped using alcohol in the past year differed from those with no lifetime use only in gender ( 60 % vs. 22 % ) ; however , patients no longer using alcohol in the last year were less likely than those still using to have a current drug use disorder ( 16 % vs. 3 % ) or last-month drug use ( 52 % vs. 30 % ) , and had fewer current risky behaviors ( 1.3 vs. 0.6 ) .
RESULTS	Among patients with last-year alcohol use , those with past alcohol use disorders differed from those without only by higher prevalence of drug use disorder ( 84 % vs. 47 % ) and drug use after HCV diagnosis ( 67 % vs. 43 % ) .
CONCLUSIONS	Patients who had stopped using alcohol for at least a year were much like those who never used alcohol in regard to other drug use , psychiatric history , smoking , and risky behaviors .
CONCLUSIONS	These findings indicate that HCV patients with at least a year of abstinence from alcohol , including those with a history of alcohol use disorder , should be considered HCV treatment candidates .

###25098487
BACKGROUND	Telephone triage is increasingly used to manage workload in primary care ; however , supporting evidence for this approach is scarce .
BACKGROUND	We aimed to assess the effectiveness and cost consequences of general practitioner - ( GP ) - led and nurse-led telephone triage compared with usual care for patients seeking same-day consultations in primary care .
METHODS	We did a pragmatic , cluster-randomised controlled trial and economic evaluation between March 1 , 2011 , and March 31 , 2013 , at 42 practices in four centres in the UK .
METHODS	Practices were randomly assigned ( 1:1:1 ) , via a computer-generated randomisation sequence minimised for geographical location , practice deprivation , and practice list size , to either GP-led triage , nurse-led computer-supported triage , or usual care .
METHODS	We included patients who telephoned the practice seeking a same-day face-to-face consultation with a GP .
METHODS	Allocations were concealed from practices until after they had agreed to participate and a stochastic element was included within the minimisation algorithm to maintain concealment .
METHODS	Patients , clinicians , and researchers were not masked to allocation , but practice assignment was concealed from the trial statistician .
METHODS	The primary outcome was primary care workload ( patient contacts , including those attending accident and emergency departments ) in the 28 days after the first same-day request .
METHODS	Analyses were by intention to treat and per protocol .
METHODS	This trial was registered with the ISRCTN register , number ISRCTN20687662 .
RESULTS	We randomly assigned 42 practices to GP triage ( n = 13 ) , nurse triage ( n = 15 ) , or usual care ( n = 14 ) , and 20,990 patients ( n = 6695 vs 7012 vs 7283 ) were randomly assigned , of whom 16,211 ( 77 % ) patients provided primary outcome data ( n = 5171 vs 5468 vs 5572 ) .
RESULTS	GP triage was associated with a 33 % increase in the mean number of contacts per person over 28 days compared with usual care ( 265 [ SD 174 ] vs 191 [ 143 ] ; rate ratio [ RR ] 133 , 95 % CI 130-136 ) , and nurse triage with a 48 % increase ( 281 [ SD 168 ] ; RR 148 , 95 % CI 144-152 ) .
RESULTS	Eight patients died within 7 days of the index request : five in the GP-triage group , two in the nurse-triage group , and one in the usual-care group ; however , these deaths were not associated with the trial group or procedures .
RESULTS	Although triage interventions were associated with increased contacts , estimated costs over 28 days were similar between all three groups ( roughly 75 per patient ) .
CONCLUSIONS	Introduction of telephone triage delivered by a GP or nurse was associated with an increase in the number of primary care contacts in the 28 days after a patient 's request for a same-day GP consultation , with similar costs to those of usual care .
CONCLUSIONS	Telephone triage might be useful in aiding the delivery of primary care .
CONCLUSIONS	The whole-system implications should be assessed when introduction of such a system is considered .
BACKGROUND	Health Technology Assessment Programme UK National Institute for Health Research .

###24691218
OBJECTIVE	To explore the effectiveness and participant experience of web-based physiotherapy for people moderately affected with Multiple Sclerosis ( MS ) and to provide data to establish the sample size required for a fully powered , definitive randomized controlled study .
METHODS	A randomized controlled pilot study .
METHODS	Rehabilitation centre and participants ' homes .
METHODS	Thirty community dwelling adults moderately affected by MS ( Expanded Disability Status Scale 5-6 .5 ) .
METHODS	Twelve weeks of individualised web-based physiotherapy completed twice per week or usual care ( control ) .
METHODS	Online exercise diaries were monitored ; participants were telephoned weekly by the physiotherapist and exercise programmes altered remotely by the physiotherapist as required .
METHODS	The following outcomes were completed at baseline and after 12 weeks ; 25 Foot Walk , Berg Balance Scale , Timed Up and Go , Multiple Sclerosis Impact Scale , Leeds MS Quality of Life Scale , MS-Related Symptom Checklist and Hospital Anxiety and Depression Scale .
METHODS	The intervention group also completed a website evaluation questionnaire and interviews .
RESULTS	Participants reported that website was easy to use , convenient , and motivating and would be happy to use in the future .
RESULTS	There was no statistically significant difference in the primary outcome measure , the timed 25ft walk in the intervention group ( P = 0.170 ) , or other secondary outcome measures , except the Multiple Sclerosis Impact Scale ( P = 0.048 ) .
RESULTS	Effect sizes were generally small to moderate .
CONCLUSIONS	People with MS were very positive about web-based physiotherapy .
CONCLUSIONS	The results suggested that 80 participants , 40 in each group , would be sufficient for a fully powered , definitive randomized controlled trial .

###25268656
BACKGROUND	Botulinum toxin injections are used to treat spasticity in stroke .
BACKGROUND	Although this treatment is effective on muscle tone , its effect on functional gait-related activities remains uncertain .
OBJECTIVE	The aim of this randomized controlled trial was to determine the effect of a self-rehabilitation programme as an adjunct to botulinum toxin injections on gait-related activities in patients with chronic hemiparesis .
METHODS	Thirty-five outpatients were included .
METHODS	Each patient was randomized to 1 of 2 groups : botulinum toxin + standardized self-rehabilitation programme ( R group , n = 19 ) or botulinum toxin alone ( C group , n = 16 ) .
METHODS	Each patient was evaluated with the following tests before botulinum toxin injections and one month afterwards : 10-m timed walk , Timed Up and Go , distance covered in 6 min over an ecological circuit , and the stair test .
RESULTS	There were significant improvements in the R group compared with the C group : maximal gait speed improved by 8 % ( p = 0.003 ) ; distance covered in 6 min over an ecological circuit increased by 7.1 % ( p = 0.01 ) ; and time to ascend and to descend a flight of stairs decreased by 9.8 % ( p = 0.003 ) and 6.6 % ( p = 0.009 ) , respectively .
RESULTS	The self-rehabilitation programme was well tolerated and safe .
CONCLUSIONS	These results strongly suggest that a standardized self-rehabilitation programme constitutes a useful adjunct to botulinum toxin injections in order to improve gait-related activities .

###25244562
OBJECTIVE	Headache is a common health problem in adolescents .
OBJECTIVE	There are a number of risk factors for headache in adolescents that are amenable to intervention .
OBJECTIVE	The aim of the study was to assess the effectiveness of a low-level headache prevention programme in the classroom setting to prevent these risk factors .
METHODS	In all , 1674 students in 8th-10th grade at 12 grammar schools in greater Munich , Germany , were cluster randomized into intervention and control groups .
METHODS	A standardized 60-min prevention lesson focusing on preventable risk factors for headache ( physical inactivity , coffee consumption , alcohol consumption and smoking ) and providing instructions on stress management and neck and shoulder muscle relaxation exercises was given in a classroom setting .
METHODS	Seven months later , students were reassessed .
METHODS	The main outcome parameter was headache cessation .
METHODS	Logistic regression models with random effects for cluster and adjustment for baseline risk factors were calculated .
RESULTS	Nine hundred students ( intervention group N = 450 , control group N = 450 ) with headache at baseline and complete data for headache and confounders were included in the analysis .
RESULTS	Headache cessation was observed in 9.78 % of the control group compared with 16.22 % in the intervention group ( number needed to treat = 16 ) .
RESULTS	Accounting for cluster effects and confounders , the probability of headache cessation in the intervention group was 1.77 ( 95 % confidence interval = [ 1.08 ; 2.90 ] ) higher than in the control group .
RESULTS	The effect was most pronounced in adolescents with tension-type headache : odds ratio = 2.11 ( 95 % confidence interval = [ 1.15 ; 3.80 ] ) .
CONCLUSIONS	Our study demonstrates the effectiveness of a one-time , classroom-based headache prevention programme .

###24338736
OBJECTIVE	To investigate the associations of NOS1AP rs12742393 polymorphism with the risk of type 2 diabetes mellitus ( T2DM ) and repaglinide therapeutic efficacy in Chinese patients with T2DM .
METHODS	Prospective case-control study .
METHODS	Academic medical center .
METHODS	A total of 300 patients with T2DM and 200 healthy volunteers were enrolled to identify NOS1AP rs12742393 genotypes using the polymerase chain reaction-restriction fragment length polymorphism assay .
METHODS	Eighty-four patients with various genotypes were randomly selected to receive oral repaglinide as a single-agent therapy ( 3mg/day ) for 8weeks .
RESULTS	Anthropometric measurements and fasting plasma glucose ( FPG ) , postprandial plasma glucose , hemoglobin A1c , fasting serum insulin ( FINS ) , postprandial serum insulin , homeostasis model assessment for insulin resistance ( HOMA-IR ) , triglyceride , total cholesterol , low-density lipoprotein-cholesterol , and high-density lipoprotein-cholesterol tests were obtained before and after repaglinide treatment .
RESULTS	The risk C allelic frequency of NOS1AP rs12742393 was higher in patients with T2DM than in healthy volunteers ( p < 0.001 ) .
RESULTS	Patients with T2DM and genotypes AA and AC at NOS1AP rs12742393 had a significant reduction in FPG ( mmol/l ) compared with those with genotype CC ( p < 0.01 ) .
RESULTS	Patients with CC homozygotes and AC heterozygotes had a greater increase in FINS ( mU/l ) than those with wild-type AA ( p < 0.05 ) .
RESULTS	In addition , the carriers of genotype CC at NOS1AP rs12742393 had higher differential values of HOMA-IR compared with genotypes AC and AA carriers ( p < 0.001 ) .
RESULTS	The effects of repaglinide treatment on FPG ( p < 0.01 ) , FINS ( p < 0.05 ) and HOMA-IR ( p < 0.001 ) were reduced in patients with T2DM carrying the NOS1AP rs12742393 risk C allele compared with the AA genotype carriers .
CONCLUSIONS	The NOS1AP rs12742393 polymorphism is associated with therapeutic efficacy of repaglinide in Chinese T2DM patients .

###24819761
OBJECTIVE	Lactoferrin ( LF ) , a non-haem iron binding glycoprotein , shares antimicrobial properties with innate immune system components influencing proinflammatory release of cytokines involved in psoriatic plaque development .
OBJECTIVE	The objective of the study was to verify if LF could provide a therapeutic application in psoriasis .
METHODS	An open-label , two arms , 4-week trial was designed on 30 subjects affected by mild to moderate plaque psoriasis .
METHODS	All patients received oral bovine LF 100 mg .
METHODS	Fifteen patients ( group A ) were topically treated with 10 % LF ointment , 15 patients ( group B ) with 20 % LF ointment .
METHODS	All patients applied only ointment vehicle on contra lateral target lesion as intra-patient side to side control .
METHODS	Efficacy was assessed by Target Lesion Score .
RESULTS	Twenty-two patients completed the study .
RESULTS	Improvement in elevation , redness and scaling was observed on LF treated psoriatic target lesions comparing to the controlateral controls ( P < 0.05 ) .
RESULTS	There was no additional efficacy for 20 % versus 10 % topical applications .
RESULTS	Oral drug alone did not exert any improvement on the control plaques receiving topical placebo .
CONCLUSIONS	Our clinical results suggest that LF could be included as a possible safe topical therapeutic option in the treatment of psoriatic plaque .

###24758641
BACKGROUND	The negative impact of rising progesterone levels on pregnancy rates is well known , but data on mature oocyte yield are conflicting .
BACKGROUND	We examined whether delaying the oocyte maturation trigger in IVF/ICSI affected the number of mature oocytes and investigated the potential influence of serum progesterone levels in this process .
METHODS	Between January 31 , 2011 , and December 31 , 2011 , 262 consecutive patients were monitored using ultrasound plus hormonal evaluation .
METHODS	Those with > = 3 follicles with a mean diameter of > = 18 mm were divided into 2 groups depending on their serum progesterone levels .
METHODS	In cases with a progesterone level < = 1 ng/ml , which was observed in 59 patients , 30-50 % of their total number of follicles ( only counting those larger than 10 mm ) were at least 18 mm in diameter .
METHODS	These patients were randomised into 2 groups : in one group , final oocyte maturation was triggered the same day ; for the other , maturation was triggered 24 hours later .
METHODS	Seventy-two patients with progesterone levels > 1 ng/ml were randomised in the same manner , irrespective of the percentage of larger follicles ( > = 18 mm ) .
METHODS	The number of metaphase II oocytes was our primary outcome variable .
METHODS	Because some patients were included more than once , correction for duplicate patients was performed .
RESULTS	In the study arm with low progesterone ( < = 1 ng/ml ) , the mean number of metaphase II oocytes ( + / - SD ) was 10.29 ( + / -6.35 ) in the group with delayed administration of the oocyte maturation trigger versus 7.64 ( + / -3.26 ) in the control group .
RESULTS	After adjusting for age , the mean difference was 2.41 ( 95 % CI : 0.22-4 .61 ; p = 0.031 ) .
RESULTS	In the study arm with elevated progesterone ( > 1 ng/ml ) , the mean numbers of metaphase II oocytes ( + / - SD ) were 11.81 ( + / -9.91 ) and 12.03 ( + / -7.09 ) for the delayed and control groups , respectively .
RESULTS	After adjusting for PCOS ( polycystic ovary syndrome ) and female pathology , the mean difference was -0.44 ( 95 % CI : -3.65 -2.78 ; p = 0.79 ) .
CONCLUSIONS	Delaying oocyte maturation in patients with low progesterone levels yields greater numbers of mature oocytes .

###24413721
BACKGROUND	Calcium dobesilate is an antioxidant drug and this study is aimed to investigate the effects of calcium dobesilate on gentamicin-induced nephrotoxicity .
METHODS	This experimental study was conducted on 40 male Sprague-Dawley rats .
METHODS	The rats were randomly divided into the following 5 groups : control , sham , gentamicin ( 100 mg/kg/d , intraperitoneal ) , gentamicin and calcium dobesilate ( 50 mg/kg body weight ) , gentamicin and calcium dobesilate ( 50 mg/kg body weight ) .
METHODS	Treatment was provided once a day in a 7-day period .
METHODS	At the end of the 7th day , plasma and urine samples were taken and the concentrations of creatinine , urea nitrogen , sodium , potassium , and osmolarity were measured in both samples .
METHODS	The level of oxidative stress in the left kidney tissue samples was also assessed by measuring malondialdehyde and ferric reducing antioxidant power .
RESULTS	Calcium dobesilate intake with both doses led to a significant decrease in the elevated concentration of creatinine , urea nitrogen , and fractional excretion of sodium by gentamicin , and an increase in creatinine clearance and absolute excretion of potassium as compared to the gentamicin group .
RESULTS	Furthermore , calcium dobesilate decreased tissue malondialdehyde and increased tissue ferric reducing antioxidant power at both doses , in comparison to those in the gentamicin group .
CONCLUSIONS	Calcium dobesilate is capable of protecting rats against gentamicin-induced nephrotoxicity .
CONCLUSIONS	This protective effect of calcium dobesilate is probably dependent on its antioxidant properties .

###26011971
OBJECTIVE	To compare postoperative pain following laser-assisted subepithelial keratectomy ( LASEK ) and transepithelial photorefractive keratectomy ( T-PRK , two-step surgery ) and alleviate postoperative subjective pain .
METHODS	Thirty patients ( 60 eyes ) with myopia or myopic astigmatism were consecutively recruited into this prospective , randomized paired study .
METHODS	Patients underwent LASEK in one eye , and T-PRK in the other .
METHODS	The degree of pain was rated on a scale of 0-10 on postoperative days 1 , 2 and 3 .
METHODS	Uncorrected visual acuity ( UCVA ) and subepithelial corneal haze were assessed at postoperative 1 and 3 months .
RESULTS	The pain was relieved on the 4th postoperative day in all patients , healing of corneal epithelium was observed at 4-5 days after surgery and contact lenses were removed promptly .
RESULTS	At postoperative 1 day , the mean subjective pain score in the LASEK group was 3.2 1.88 and 4.43 1.61 in T-PRK group ( P = 0.008 ) .
RESULTS	No significant difference was found between two groups on postoperative 2 and 3 days .
RESULTS	At postoperative 3 months , the percentage of UCVA 0.8 in the LASEK group was 100 % and 96.7 % in the T-PRK group ( P = 0.24 ) , 93.3 % of patients in the LASEK with UCVA 1.0 and 90 % in the T-PRK group ( P = 0.64 ) .
RESULTS	In the LASEK group , the value of corneal haze was 0.26 0.21 and 0.27 0.25 in the T-PRK group ( P = 0.877 ) .
CONCLUSIONS	Good visual acuity was obtained in both groups at postoperative 3 months .
CONCLUSIONS	Compared with those in the T-PRK group , patients undergoing had less discomfort in the LASEK group , which may be associated with corneal epithelial activity .
CONCLUSIONS	The changing curve of subjective pain in the T-PRK group was relatively flat and stable at postoperative 3 days .

###24252510
BACKGROUND	Obesity affects 25 % of the UK adult population but modest weight loss can reduce the incidence of obesity-related chronic disease .
BACKGROUND	Some effective weight loss treatments exist but there is no nationally available National Health Service ( NHS ) treatment service , and general practitioners ( GPs ) rarely discuss weight management with patients or support behavior change .
BACKGROUND	Evidence shows that commercial weight management services , that most primary care trusts have ` on prescription ' , are more effective than primary care treatment .
METHODS	We propose a controlled trial where patients will be randomized to receive either the offer of help by referral to a weight management service and follow-up to assess progress , or advice to lose weight on medical grounds .
METHODS	The primary outcome will be weight change at 12-months .
METHODS	Other questions are : what actions do people take to manage their weight in response to the two GP intervention types ?
METHODS	How do obese patients feel about GPs opportunistically discussing weight management and how does this vary by intervention type ?
METHODS	How do GPs feel about raising the issue opportunistically and giving the two types of brief intervention ?
METHODS	What is the cost per kg/m2 lost for each intervention ?
METHODS	Research assistants visiting GP practices in England ( n = 60 ) would objectively measure weight and height prior to GP consultations and randomize willing patients ( body mass index 30 + , excess body fat , 18 + years ) using sealed envelopes .
METHODS	Full recruitment ( n = 1824 ) is feasible in 46weeks , requiring six sessions of advice-giving per GP .
METHODS	Participants will be contacted at 3months ( postintervention ) via telephone to identify actions they have taken to manage their weight .
METHODS	We will book appointments for participants to be seen at their GP practice for a 12-month follow-up .
CONCLUSIONS	Trial results could make the case for brief interventions for obese people consulting their GP and introduce widespread simple treatments akin to the NHS Stop Smoking Service .
CONCLUSIONS	Likewise , the intervention could be introduced in the Quality and Outcomes Framework and influence practice worldwide .
BACKGROUND	Current Controlled Trials ISRCTN26563137 .

###24280477
BACKGROUND	Anorexia nervosa is a serious illness with significant morbidity .
BACKGROUND	The evidence base for existing psychological and pharmacological interventions to manage anorexia nervosa is not strong , and use of new adjunctive therapies that improve the effectiveness of existing treatments , and lead to improved mental health outcomes for this patient group is highly desirable .
BACKGROUND	This study investigates the views of patients with anorexia nervosa receiving an acupuncture or acupressure intervention .
METHODS	A randomised controlled trial was conducted in Sydney , Australia .
METHODS	Twenty-six inpatients with a diagnosis of anorexia nervosa were randomised to a six week intervention of acupuncture or acupressure with light massage .
METHODS	Treatment was administered twice weekly for three weeks , then weekly for three weeks .
METHODS	A post treatment questionnaire was administered to explore participant views , of the study consultation .
METHODS	Questions examined important aspects of the clinical encounter including the , patient 's perception of the practitioners ' relational empathy ( CARE ) , treatment perceptions and the , therapeutic relationship .
RESULTS	Participants in both groups scored highly on the CARE scale assessing empathy and the , therapeutic relationship .
RESULTS	There was no difference in the mean CARE scores for the acupuncture group ( 50 ( SD 0.0 ) ) and the acupressure group ( 49.5 ( SD 0.8 ) ) .
RESULTS	Participants highly valued the therapeutic , encounter and in particular the characteristics of empathy , positive regard , acceptance , non , judgmental responses and trust .
RESULTS	Having someone to talk to , being less stressed/relaxed and contact , with the study staff were also perceived to be important .
CONCLUSIONS	Study participants perceive the therapeutic relationship and empathy as important qualities of the acupuncture or acupressure intervention as an adjunct therapy for the treatment of anorexia nervosa .

###24796339
OBJECTIVE	Delcasertib is a selective inhibitor of delta-protein kinase C ( delta-PKC ) , which reduced infarct size during ischaemia/reperfusion in animal models and diminished myocardial necrosis and improved reperfusion in a pilot study during primary percutaneous coronary intervention ( PCI ) for ST elevation myocardial infarction ( STEMI ) .
RESULTS	A multicentre , double-blind trial was performed in patients presenting within 6 h and undergoing primary PCI for anterior ( the primary analysis cohort , n = 1010 patients ) or inferior ( an exploratory cohort , capped at 166 patients ) STEMI .
RESULTS	Patients with anterior STEMI were randomized to placebo or one of three doses of delcasertib ( 50 , 150 , or 450 mg/h ) by intravenous infusion initiated before PCI and continued for 2.5 h.
RESULTS	There were no differences between treatment groups in the primary efficacy endpoint of infarct size measured by creatine kinase MB fraction area under the curve ( AUC ) ( median 5156 , 5043 , 4419 , and 5253 ng h/mL in the placebo , delcasertib 50 , 150 , and 450 mg/mL groups , respectively ) in the anterior STEMI cohort .
RESULTS	No treatment-related differences were seen in secondary endpoints of infarct size , electrocardiographic ST-segment recovery AUC or time to stable ST recovery , or left ventricular ejection fraction at 3 months .
RESULTS	No differences in rates of adjudicated clinical endpoints ( death , heart failure , or serious ventricular arrhythmias ) were observed .
CONCLUSIONS	Selective inhibition of delta-PKC with intravenous infusion of delcasertib during PCI for acute STEMI in a population of patients treated according to contemporary standard of care did not reduce biomarkers of myocardial injury .

###25109416
OBJECTIVE	The aim of this study was to compare lung deposition and assess the bioequivalence of two formulations containing budesonide and formoterol and being delivered via Elpenhaler and Turbuhaler , respectively .
OBJECTIVE	A pharmacokinetic ( PK ) study was conducted .
METHODS	An open , randomized , two-sequence , two-period , crossover , single-dose study in 100 asthmatic patients under fasting conditions was performed .
METHODS	Wash out period was 6 days .
METHODS	Equivalence in lung deposition was assessed after a single inhalation of each treatment with concomitant oral administration of activated charcoal ( 40g ) to prevent gastrointestinal absorption of the drugs .
METHODS	Several PK parameters were estimated , the area under the drug concentration in plasma versus time curve ( AUC0-t ) and the maximum drug concentration in plasma ( Cmax ) being the primary response variables .
METHODS	Equivalent lung deposition was concluded if the 90 % confidence interval ( CI ) for the Elpenhaler/Turbuhaler geometric mean ratio of AUC0-t and Cmax , for both drug substances fell within the regulatory limits ( 0.80-1 .25 ) .
RESULTS	Acceptance criteria were met .
RESULTS	Equivalent lung deposition can be concluded .
RESULTS	No statistically significant differences between treatments in the incidence of adverse events were found .
CONCLUSIONS	The formulations are bioequivalent regarding both rate and extent of absorption .
CONCLUSIONS	The treatments were also well tolerated by the participating subjects .

###25069199
OBJECTIVE	To evaluate the effect of Dexmedetomidine and Midazolam on respiratory and circulation in patients experiencing open heart surgery under acupuncture-assisted general anesthesia .
METHODS	Sixty patients undergoing open heart surgery ( cardiac valve replacement surgery and aortic valve replacement surgery ) were randomly and equally divided into Dexmedetomidine ( D ) and Midazolam ( M ) groups .
METHODS	Electroacupuncture ( EA ) was applied to bilateral Yunmen ( LU 2 ) , Zhongfu ( LU1 ) , Lieque ( LU7 ) and Neiguan ( PC6 ) .
METHODS	For patients of group D , Dexmedetomidine ( i.v. , loading dose : 1 microg/kg , and succedent dose : 0.2-1 microg x kg ( -1 ) x h ( -1 ) ) was given .
METHODS	For patients of group M , Midazolam ( i.v. , loading dose : 0.05 mg/kg , succedent dose : 0.01-0 .03 mg x kg ( -1 ) x h ( -1 ) ) was given .
METHODS	Arterial oxygen pressure ( PaO2 ) , arterial carbondioxide tension ( PaCO2 ) , O2 saturation ( SPO2 ) , mean arterial pressure ( MAP ) , heart rate ( HR ) , anesthetic effect , time of spontaneous breathing recovery , and time of resuscitation were recorded before operation ( T0 ) , immediately after skin incision ( T1 ) , immediately after sternotomy ( T2 ) , before suspension of cardiopulmonary bypass ( CPB , T3 ) , immediately after cardiac re-beating ( T4 ) , immediately after CPB cessation ( T5 ) , and at the end of surgery ( T6 ) .
RESULTS	Before operation , no significant differences were found between the group D and M in the levels of PaO2 , PaCO2 and SPO2 ( P > 0.05 ) .
RESULTS	The PaO2 and SPO2 levels after skin incision , sternotomy , before suspension of CPB and at the end of surgery were significantly lower in group M than in group D ( P < 0.05 ) , while the le - vels of PaCO2 after skin incision , sternotomy , before suspension of CPB and at the end of surgery , and HR after skin incision , sternotomy , before suspension of CPB , after heart re-beating , after CPB cessation and at the end of surgery in group M were considerably higher than those in group D ( P < 0.05 ) .
RESULTS	In addition , the time of spontaneous breathing recovery of group M was significantly later than that of group D ( P < 0.05 ) .
RESULTS	No significant differences were found between the two groups in MAP levels at the 6 time-points during surgery , in the PaO2 , PaCO2 and SPO2 levels at the time-points of post-cardiac re-beating , and after CPB cessation ( P > 0.05 ) .
RESULTS	It suggested that the respiration and circulation states in group D were more smoothly than those in group M.
RESULTS	There was no significant difference between the two groups in the time of resuscitation ( P > 0.05 ) .
CONCLUSIONS	Dexmedetomidine is superior to Midazolam in analgesia , and improving respiration and circulation functions for open heart surgery patients under acupuncture-assisted general anesthesia .

###25882510
BACKGROUND	We aimed to assess the safety and efficacy of thrombectomy for the treatment of stroke in a trial embedded within a population-based stroke reperfusion registry .
METHODS	During a 2-year period at four centers in Catalonia , Spain , we randomly assigned 206 patients who could be treated within 8 hours after the onset of symptoms of acute ischemic stroke to receive either medical therapy ( including intravenous alteplase when eligible ) and endovascular therapy with the Solitaire stent retriever ( thrombectomy group ) or medical therapy alone ( control group ) .
METHODS	All patients had confirmed proximal anterior circulation occlusion and the absence of a large infarct on neuroimaging .
METHODS	In all study patients , the use of alteplase either did not achieve revascularization or was contraindicated .
METHODS	The primary outcome was the severity of global disability at 90 days , as measured on the modified Rankin scale ( ranging from 0 [ no symptoms ] to 6 [ death ] ) .
METHODS	Although the maximum planned sample size was 690 , enrollment was halted early because of loss of equipoise after positive results for thrombectomy were reported from other similar trials .
RESULTS	Thrombectomy reduced the severity of disability over the range of the modified Rankin scale ( adjusted odds ratio for improvement of 1 point , 1.7 ; 95 % confidence interval [ CI ] , 1.05 to 2.8 ) and led to higher rates of functional independence ( a score of 0 to 2 ) at 90 days ( 43.7 % vs. 28.2 % ; adjusted odds ratio , 2.1 ; 95 % CI , 1.1 to 4.0 ) .
RESULTS	At 90 days , the rates of symptomatic intracranial hemorrhage were 1.9 % in both the thrombectomy group and the control group ( P = 1.00 ) , and rates of death were 18.4 % and 15.5 % , respectively ( P = 0.60 ) .
RESULTS	Registry data indicated that only eight patients who met the eligibility criteria were treated outside the trial at participating hospitals .
CONCLUSIONS	Among patients with anterior circulation stroke who could be treated within 8 hours after symptom onset , stent retriever thrombectomy reduced the severity of post-stroke disability and increased the rate of functional independence .
CONCLUSIONS	( Funded by Fundaci Ictus Malaltia Vascular through an unrestricted grant from Covidien and others ; REVASCAT ClinicalTrials.gov number , NCT01692379 . )

###24332324
OBJECTIVE	Pain is the most encountered complication following third molar surgery .
OBJECTIVE	Although nonsteroidal anti-inflammatory drugs are often used for pain control , the effect of preemptive lornoxicam has not been detailed .
OBJECTIVE	We compare the analgesic efficacy of preemptive lornoxicam versus postoperative lornoxicam .
METHODS	Forty-three participants aged 18 to 33 years who had bilateral , symmetrical third molars were included in this double-blind , randomized , placebo-controlled study .
METHODS	All participants took part in each of the 2 groups for a 1-month interval ( crossover design ) .
METHODS	Group Pre received lornoxicam 8 mg intravenously 25 minutes before surgery and 2 mL serum saline postoperatively .
METHODS	Group Post was given the opposite protocol .
METHODS	Pain was evaluated by visual analog scale in the first 12 hours .
RESULTS	We observed statistically significant differences in the reduction of the pain level in group Pre ( P < .05 ) .
RESULTS	These participants felt less pain in the first 5 postoperative hours and needed fewer analgesics in the first 12 postoperative hours .
CONCLUSIONS	Preemptive lornoxicam is effective for postoperative pain control .

###24650323
OBJECTIVE	The objective of this study was to test the effect of sugar-free chewing gum sweetened with xylitol or maltitol compared to the use of a gum base or no gum on gingivitis and plaque scores under both brushing and non-brushing circumstances .
METHODS	The design of the study was a four-group , double-blinded , randomized controlled study with a 3-week duration .
METHODS	In each group , the participants did not brush the teeth in the lower jaw designated to develop experimental gingivitis , while maintaining normal oral hygiene procedures in the upper jaw .
METHODS	After professional dental prophylaxis , the participants were allocated into one of four groups ( xylitol , maltitol , gum base or no gum ) .
METHODS	Chewing gum was used five times a day for 10 min .
RESULTS	220 participants completed the study and provided evaluable data .
RESULTS	The increase in bleeding on marginal probing ( BOMP ) and plaque scores ( PS ) in the non-brushed ( lower ) jaw with experimental gingivitis was significant in all groups ( P < 0.001 ) .
RESULTS	As compared to the gum base , the increase in BOMP in the xylitol and maltitol group was significantly lower .
RESULTS	In the brushed upper jaw , no significant changes for BOMP were observed from the baseline to the end point of the study , and there were no significant differences in BOMP and PS between the groups .
CONCLUSIONS	In circumstances where regular brushing is performed , no effect of chewing gum was observed on bleeding and plaque scores .
CONCLUSIONS	In the absence of brushing , chewing xylitol or maltitol gum provided a significant inhibitory effect on gingivitis scores compared to chewing gum base .
CONCLUSIONS	The difference when compared to the group not using gum was not significant .

###24304605
BACKGROUND	Due to structural differences , bioavailability of krill oil , a phospholipid based oil , could be higher than fish oil , a triglyceride-based oil , conferring properties that render it more effective than fish oil in increasing omega-3 index and thereby , reducing cardiovascular disease ( CVD ) risk .
OBJECTIVE	The objective was to assess the effects of krill oil compared with fish oil or a placebo control on plasma and red blood cell ( RBC ) fatty acid profile in healthy volunteers .
METHODS	Twenty four healthy volunteers were recruited for a double blinded , randomized , placebo-controlled , crossover trial .
METHODS	The study consisted of three treatment phases including krill or fish oil each providing 600 mg of n-3 polyunsaturated fatty acids ( PUFA ) or placebo control , corn oil in capsule form .
METHODS	Each treatment lasted 4 wk and was separated by 8 wk washout phases .
RESULTS	Krill oil consumption increased plasma ( p = 0.0043 ) and RBC ( p = 0.0011 ) n-3 PUFA concentrations , including EPA and DHA , and reduced n-6 : n-3 PUFA ratios ( plasma : p = 0.0043 , RBC : p = 0.0143 ) compared with fish oil consumption .
RESULTS	Sum of EPA and DHA concentrations in RBC , the omega-3 index , was increased following krill oil supplementation compared with fish oil ( p = 0.0143 ) and control ( p < 0.0001 ) .
RESULTS	Serum triglycerides and HDL cholesterol concentrations did not change with any of the treatments .
RESULTS	However , total and LDL cholesterol concentrations were increased following krill ( TC : p = 0.0067 , LDL : p = 0.0143 ) and fish oil supplementation ( TC : p = 0.0028 , LDL : p = 0.0143 ) compared with control .
CONCLUSIONS	Consumption of krill oil was well tolerated with no adverse events .
CONCLUSIONS	Results indicate that krill oil could be more effective than fish oil in increasing n-3 PUFA , reducing n-6 : n-3 PUFA ratio , and improving the omega-3 index .
BACKGROUND	ClinicalTrials.gov , NCT01323036 .

###24493716
OBJECTIVE	R-CHOP ( rituximab plus cyclophosphamide , doxorubicin , vincristine , and prednisone ) is standard care for aggressive B-cell lymphoma .
OBJECTIVE	A prospective trial was conducted to investigate the role of additive radiotherapy ( RT ) to bulky and extralymphatic disease .
METHODS	The best arm of the RICOVER-60 trial ( 6R-CHOP-14 +2 R [ R-CHOP administered once every 2 weeks plus two additional applications of rituximab ] plus involved-field RT [ 36 Gy ] to sites of initial bulky [ 7.5 cm ] disease and extralymphatic involvement ) was compared with a cohort receiving the same immunochemotherapy but without RT in an amendment to the RICOVER-60 trial ( RICOVER-noRTh ) in a prospective fashion .
RESULTS	After a median observation time of 39 months , 164 of 166 RICOVER-noRTh patients were evaluable .
RESULTS	In a multivariable analysis of the intention-to-treat population adjusting for International Prognostic Index risk factors and age ( > 70 years ) , event-free survival ( EFS ) of patients with bulky disease was inferior without additive RT ( hazard ratio [ HR ] , 2.1 ; 95 % CI , 1.3 to 3.5 ; P = .005 ) , with trends for inferior progression-free ( PFS ; HR , 1.8 ; 95 % CI , 1.0 to 3.3 ; P = .058 ) and overall survival ( OS ; HR , 1.6 ; 95 % CI , 0.9 to 3.1 ; P = .127 ) .
RESULTS	In a per-protocol analysis with 11 patients in RICOVER-noRTh excluded for receiving unplanned RT , multivariable analysis revealed HRs of 2.7 ( 95 % CI , 1.3 to 5.9 ; P = .011 ) for EFS , 4.4 ( 95 % CI , 1.8 to 10.6 ; P = .001 ) for PFS , and 4.3 ( 95 % CI , 1.7 to 11.1 ; P = .002 ) for OS for patients not receiving RT to bulky disease .
CONCLUSIONS	Additive RT to bulky sites abrogates bulky disease as a risk factor and improves outcome of elderly patients with aggressive B-cell lymphoma .
CONCLUSIONS	Whether RT can be spared in patients with ( metabolic ) complete remission after immunochemotherapy must be addressed in appropriately designed prospective trials .

###24561962
OBJECTIVE	The purpose of this study was to investigate the role of ( hyperopic or myopic ) spectacle correction in reading speed of 9 - to 10-year-old children .
METHODS	Subjects were recruited at their schools .
METHODS	Initial selection was based on reduced distance acuity and/or a positive blur test .
METHODS	Final inclusion depended on cycloplegic refraction .
METHODS	Forty-three myopes were prescribed glasses .
METHODS	Sixty-five hyperopes were randomized to three groups : ( 1 ) no glasses , ( 2 ) +0.5 DS for both eyes , and ( 3 ) full correction .
METHODS	Before and 4 to 6 months after prescription of glasses , reading speed was tested : One-Minute Test ( reading speed of genuine words ) and the Klepel ( reading speed of nonwords ) .
METHODS	Data for this second reading test were obtained in 34 myopes and 48 hyperopes .
RESULTS	At baseline , myopes had about 11 % higher One-Minute scores ( p = 0.005 ) and about 9 % higher Klepel scores ( p = 0.066 ) than hyperopes .
RESULTS	At follow-up , the hyperopia-full correction group improved its One-Minute score by about 13 % more than both the no-glasses group ( p = 0.012 ) and +0.5 DS group ( p = 0.019 ) .
RESULTS	Spectacles did not , or only slightly , improve reading scores of myopes ( One-Minute scores , p = 0.068 ; Klepel scores , p = 0.021 ) .
CONCLUSIONS	Correction of hyperopia may increase speed of reading ( as reflected by the One-Minute score ) .
CONCLUSIONS	The fact that reading speed of nonwords does not increase after correction suggests that hyperopia affects speed of recognition but not decoding per se .

###24568073
BACKGROUND	Attention-deficit/hyperactivity disorder ( ADHD ) is associated with difficulties in learning , behaviour and psychosocial adjustment that persist into adulthood .
BACKGROUND	Decreased omega-3 fatty acids and increased inflammation or oxidative stress may contribute to neuro-developmental and psychiatric disorders such as ADHD .
BACKGROUND	The aim of this study was to determine the effect of n-3 supplementation on hyperactivity , oxidative stress and inflammatory mediators in children with ADHD .
METHODS	In this double blind study , 103 children ( 6-12 years ) with ADHD receiving maintenance therapy were assigned randomly into two groups .
METHODS	The n-3 group received n-3 fatty acids ( 635 mg eicosapentaenoic acid ( EPA ) , 195 mg docosahexaenoic acid ( DHA ) ) , and the placebo group received olive oil capsules which were visually similar to the n-3 capsules .
METHODS	The duration of supplementation was 8 weeks .
METHODS	Plasma C-reactive protein ( CRP ) , interleukin-6 ( IL-6 ) and the activity of glutathione reductase ( GR ) , catalase ( CAT ) and superoxide dismutase ( SOD ) were determined before and after the intervention .
METHODS	Likewise the Conners ' Abbreviated Questionnaires ( ASQ-P ) was applied .
RESULTS	After 8-week intervention , a significant reduction was observed in the levels of CRP ( P < 0.05 , 95 % CI = 0.72-2 .02 ) and IL-6 ( P < 0.001 , 95 % CI = 1.93-24 .33 ) in the n-3 group .
RESULTS	There was also a significant increase in activity of SOD and GR ( P < 0.001 ) .
RESULTS	A significant improvement was seen in the ASQ-P scores in the n-3 group ( P < 005 ) .
CONCLUSIONS	Eight weeks of EPA and DHA supplementation decreased plasma inflammatory mediators and oxidative stress in the children with ADHD .
CONCLUSIONS	These results suggest that n-3 fatty acid supplementation may offer a safe and efficacious treatment for children with ADHD .

###25118042
OBJECTIVE	To compare the fitting time requirements and the efficiency in achieving improvements in speech perception during the first 6 months after initial stimulation of computer-assisted fitting with the Fitting to Outcome eXpert ' ( FOX ) and a standard clinical fitting procedure .
METHODS	Twenty-seven post-lingually deafened adults , newly implanted recipients of the Advanced Bionics HiRes 90K cochlear implant from Germany , the UK , and France took part in a controlled , randomized , clinical study .
METHODS	Speech perception was measured for all participants and fitting times were compared across groups programmed using FOX and conventional programming methods .
RESULTS	The fitting time for FOX was significantly reduced at 14 days ( P < 0.001 ) but equivalent over the 6-month period .
RESULTS	The groups were not well matched for duration of deafness ; therefore , speech perception could not be compared across groups .
CONCLUSIONS	Despite including more objective measures of performance than a standard fitting approach and the adjustment of a greater range of parameters during initial fitting , FOX did not add to the overall fitting time when compared to the conventional approach .
CONCLUSIONS	FOX significantly reduced the fitting time in the first 2 weeks and by providing a standard fitting protocol , reduced variability across centres .
CONCLUSIONS	FOX computer-assisted fitting can be successfully used at switch on , in different clinical environments , reducing fitting time in the first 2 weeks and is efficient at providing a usable program .

###25011693
BACKGROUND	Glomerular filtration rate ( GFR ) declines during long-term dialysis treatment .
BACKGROUND	In peritoneal dialysis , blockade of the renin-angiotensin-aldosterone system reduces GFR decline .
BACKGROUND	Observational studies suggest that similar treatment may preserve kidney function in hemodialysis ( HD ) .
METHODS	A multicenter , randomized , placebo-controlled , double-blinded trial , with 1-year follow-up .
METHODS	Adult HD patients with urine output > 300mL/24h , HD vintage less than 1 year , and cardiac ejection fraction > 30 % .
METHODS	Patients were included from 6 HD centers .
METHODS	Patients were randomly assigned to placebo or the angiotensin II receptor blocker irbesartan , 300mg daily .
METHODS	Target systolic blood pressure ( BP ) was 140mm Hg .
METHODS	Primary outcomes were change in GFR measured as the mean of creatinine and urea renal clearance together with urine volume .
METHODS	Secondary outcomes were change in albuminuria , renin-angiotensin II-aldosterone hormone plasma levels , and time to anuria .
RESULTS	Of 82 patients randomly assigned ( 41 patients in each group ) , 56 completed 1 year of treatment .
RESULTS	The placebo and irbesartan groups were comparable at baseline in terms of sex balance ( 26 vs 30 men ) , mean age ( 62 vs 61 years ) , median HD vintage ( 137 vs 148 days ) , mean HD time ( 10 vs 11h/wk ) , median urine volume ( 1.19 vs 1.26 L/d ) , and mean GFR ( 4.8 vs 5.7 mL/min/1 .73 m ( 2 ) ) .
RESULTS	The target BP level was reached in both groups and BP did not differ significantly between groups over time .
RESULTS	Adverse-event rates were similar .
RESULTS	GFR declined by a mean of 1.7 ( 95 % CI , 1.2-2 .3 ) and 1.8 ( 95 % CI , 1.1-2 .4 ) mL/min/1 .73 m ( 2 ) per year in the placebo and irbesartan groups , respectively .
RESULTS	Mean difference ( baseline values minus value at 12 months ) between groups was-0 .0 ( 95 % CI,-0 .8 to 0.8 ) .
RESULTS	In each group , 4 patients became anuric .
CONCLUSIONS	GFR decline rates were lower than expected , reducing the power .
CONCLUSIONS	At equal BP levels , we found that irbesartan treatment did not affect the decline in GFR or urine volume significantly during 1 year of treatment in HD patients .
CONCLUSIONS	Irbesartan treatment was used safely in the studied population .

###24833047
OBJECTIVE	Short interpregnancy intervals are associated with adverse perinatal outcomes .
OBJECTIVE	Increased postpartum use of long-acting reversible contraception ( LARC ) could reduce short interpregnancy intervals .
OBJECTIVE	Therefore , the primary objective of our study was to evaluate if a postpartum educational script about LARC ( LARC script ) could increase postpartum LARC utilization at the 6-week postpartum visit .
METHODS	We completed a randomized controlled trial ( 1:1 ) of 800 postpartum women in Raleigh , North Carolina .
METHODS	Women were recruited from the postpartum unit and randomized to receive ( intervention ) or not receive ( control ) the LARC script prior to hospital discharge .
METHODS	We conducted follow-up phone interviews to assess LARC use after their 6-week postpartum visit .
METHODS	We used Pearson 's chi-squared test to compare LARC use between arms .
RESULTS	Between May 2011 and January 2012 , 400 women were randomized to each arm .
RESULTS	Three hundred sixty-nine women ( 92.3 % ) in each arm were successfully contacted after their 6-week postpartum visit .
RESULTS	LARC use was reported by 17.6 % and 13.3 % of women in the intervention and control arms , respectively ( p = .103 ) .
CONCLUSIONS	The LARC script did not increase LARC utilization at the 6-week postpartum visit .
CONCLUSIONS	Future studies should evaluate interventions that address both educational and systematic barriers to postpartum LARC uptake .
CONCLUSIONS	Use of a postpartum educational script focused on the intrauterine device and contraceptive implant did not increase their utilization after the 6-week postpartum visit .
CONCLUSIONS	Future studies should evaluate interventions that address both educational and systematic barriers to postpartum contraceptive uptake .

###24367124
OBJECTIVE	Although depression is a risk and prognostic factor for cardiovascular disease ( CVD ) , depression trials involving cardiac patients have not observed the anticipated cardiovascular benefits .
OBJECTIVE	To test our hypothesis that depression treatment delivered before clinical CVD onset reduces risk of CVD events , we conducted an 8-year follow-up study of the Indiana sites of the Improving Mood-Promoting Access to Collaborative Treatment ( IMPACT ) randomized controlled trial .
METHODS	Participants were 235 primary care patients 60 years or older with major depression or dysthymia who were randomized to a 12-month collaborative care program involving antidepressants and psychotherapy ( 85 without and 35 with baseline CVD ) or usual care ( 83 without and 32 with baseline CVD ) .
METHODS	Hard CVD events ( fatal/nonfatal ) were identified using electronic medical record and Medicare/Medicaid data .
RESULTS	A total of 119 patients ( 51 % ) had a hard CVD event .
RESULTS	As hypothesized , the treatment baseline CVD interaction was significant ( p = .021 ) .
RESULTS	IMPACT patients without baseline CVD had a 48 % lower risk of an event than did usual care patients ( 28 % versus 47 % , hazard ratio = 0.52 , 95 % confidence interval = 0.31-0 .86 ) .
RESULTS	The number needed to treat to prevent one event for 5 years was 6.1 .
RESULTS	The likelihood of an event did not differ between IMPACT and usual care patients with baseline CVD ( 86 % versus 81 % , hazard ratio = 1.19 , 95 % confidence interval , 0.70-2 .03 ) .
CONCLUSIONS	Collaborative depression care delivered before CVD onset halved the excess risk of hard CVD events among older , depressed patients .
CONCLUSIONS	Our findings raise the possibility that the IMPACT intervention could be used as a CVD primary prevention strategy .
BACKGROUND	clinicaltrials.gov Identifier : NCT01561105 .

###25864279
OBJECTIVE	Preeclampsia is a unique disease of pregnancy .
OBJECTIVE	Delivery via caesarean section is the most important way of terminating the pregnancy and treating preeclampsia .
OBJECTIVE	Perioperative fluid therapy is performed to maintain the circulatory volume and reduce tissue edema .
OBJECTIVE	This study evaluated the effects of hypertonic sodium chloride hydroxyethyl starch 40 ( HSH40 ) as perioperative fluid therapy for preeclampsia patients .
METHODS	Forty preeclamptic women were randomly divided into two groups : the Ringer 's solution group and the HSH40 group .
METHODS	Their ECG , HR , MAP , and SPO2 were monitored .
METHODS	Their MVP and HR were recorded at five , eight , and ten minutes after anesthesia induction and at the end of the caesarean section .
METHODS	The corresponding volume of infusion , blood loss , and urine output during the operation were also recorded .
METHODS	Venous samples were collected before HSH40 infusion and 30 min after infusion to measure the plasma concentrations of ET , TXB2 , 6-keto-PGF1 , and ANP via a radioimmunoassay .
RESULTS	HSH40 infusion significantly decreased the plasma ET levels ( p < 0.01 ) , significantly changed the plasma ANP and TXB2 levels ( p < 0.05 ) , and significantly increased the plasma 6-keto-PGF1 levels ( p < 0.01 ) in the experimental group compared with those before infusion .
RESULTS	The plasma levels of ET , ANP , TXB2 , and 6-keto-PGF1 did not significantly change in the control group .
RESULTS	Compared with T1 , MAP decreased significantly at T2 , T3 , T4 , and T5 within groups ( p < 0.05 ) and between the two groups .
RESULTS	MAP significantly changed at T2 , T3 , T4 , and T5 ( p < 0.05 ) .
RESULTS	HR did not significant change at T1 , T2 , T3 , T4 , and T5 within or between groups .
RESULTS	Volume of infusion and urine volume significantly differed between groups ( p < 0.05 ) .
CONCLUSIONS	Low-dose HSH40 lowers the plasma levels of vasoconstrictor substances ( ET and TXB2 ) and increases the levels of vasodilator substances ( 6-keto-PGF1 and ANP ) during preeclampsia .
CONCLUSIONS	It effectively maintains and stabilizes the circulating blood volume , increasing renal blood flow , which improves renal function and increases urine output .

###24698195
OBJECTIVE	To compare percutaneous nephrostomy ( PCN ) tube vs JJ ureteric stenting as the initial urinary drainage method in children with obstructive calcular anuria ( OCA ) and post-renal acute renal failure ( ARF ) due to bilateral ureteric calculi , to identify the selection criteria for the initial urinary drainage method that will improve urinary drainage , decrease complications and facilitate the subsequent definitive clearance of stones , as this comparison is lacking in the literature .
METHODS	A series of 90 children aged 12 years presenting with OCA and ARF due to bilateral ureteric calculi were included from March 2011 to September 2013 at Cairo University Pediatric Hospital in this randomised comparative study .
METHODS	Patients with grade 0-1 hydronephrosis , fever or pyonephrosis were excluded .
METHODS	No patient had any contraindication for either method of drainage .
METHODS	Stable patients ( or patients stabilised by dialysis ) were randomised ( non-blinded , block randomisation , sealed envelope method ) into PCN-tube or bilateral JJ-stent groups ( 45 patients for each group ) .
METHODS	Initial urinary drainage was performed under general anaesthesia and fluoroscopic guidance .
METHODS	We used 4.8-6 F JJ stents or 6-8 F PCN tubes .
METHODS	The primary outcomes were the safety and efficacy of both groups for the recovery of renal functions .
METHODS	Both groups were compared for operative and imaging times , complications , and the period required for a return to normal serum creatinine levels .
METHODS	The secondary outcomes included the number of subsequent interventions needed for clearance of stones .
METHODS	Additional analysis was done for factors affecting outcome within each group .
RESULTS	All presented patients completed the study with intention-to-treat analysis .
RESULTS	There was no significant difference between the PCN-tube and JJ-stent groups for the operative and imaging times , period for return to a normal creatinine level and failure of insertion .
RESULTS	There were significantly more complications in the PCN-tube group .
RESULTS	The stone size ( > 2cm ) was the only factor affecting the rates of mucosal complications , operative time and failure of insertion in the JJ-stent group .
RESULTS	The degree of hydronephrosis significantly affected the operative time for PCN-tube insertion .
RESULTS	Grade 2 hydronephrosis was associated with all cases of insertion failure in the PCN-tube group .
RESULTS	The total number of subsequent interventions needed to clear stones was significantly higher in the PCN-tube group , especially in patients with bilateral stones destined for chemolytic dissolution ( alkalinisation ) or extracorporeal shockwave lithotripsy ( ESWL ) .
CONCLUSIONS	We recommend the use of JJ stents for initial urinary drainage for stones that will be subsequently treated with chemolytic dissolution or ESWL , as this will lower the total number of subsequent interventions needed to clear the stones .
CONCLUSIONS	This is also true for stones destined for ureteroscopy ( URS ) , as JJ-stent insertion will facilitate subsequent URS due to previous ureteric stenting .
CONCLUSIONS	Mild hydronephrosis will prolong the operative time for PCN-tube insertion and may increase the incidence of insertion failure .
CONCLUSIONS	We recommend the use of PCN tube if the stone size is > 2cm , as there was a greater risk of possible iatrogenic ureteric injury during stenting with these larger ureteric stones in addition to prolongation of operative time with an increased incidence of failure .

###24620041
BACKGROUND	Hamstring strain is a common injury in sprinters and jumpers , and therefore time to return to sport and secondary prevention become of particular concern .
OBJECTIVE	To compare the effectiveness of two rehabilitation protocols after acute hamstring injury in Swedish elite sprinters and jumpers by evaluating time needed to return to full participation in the training process .
METHODS	Prospective randomised comparison of two rehabilitation protocols .
METHODS	Fifty-six Swedish elite sprinters and jumpers with acute hamstring injury , verified by MRI , were randomly assigned to one of two rehabilitation protocols .
METHODS	Twenty-eight athletes were assigned to a protocol emphasising lengthening exercises , L-protocol , and 28 athletes to a protocol consisting of conventional exercises , C-protocol .
METHODS	The outcome measure was the number of days to return to full training .
METHODS	Re-injuries were registered during a period of 12 months after return .
RESULTS	Time to return was significantly shorter for the athletes in the L-protocol , mean 49 days ( 1SD26 , range 18-107 days ) , compared with the C-protocol , mean 86 days ( 1SD34 , range 26-140 days ) .
RESULTS	Irrespective of protocol , hamstring injuries where the proximal free tendon was involved took a significantly longer time to return than injuries that did not involve the free tendon , L-protocol : mean 73 vs 31 days and C-protocol : mean 116 vs 63 days , respectively .
RESULTS	Two reinjuries were registered , both in the C-protocol .
CONCLUSIONS	A rehabilitation protocol emphasising lengthening type of exercises is more effective than a protocol containing conventional exercises in promoting time to return in Swedish elite sprinters and jumpers .

###24566903
BACKGROUND	To evaluate the efficacy of autologous serum ( AS ) eye drops for the symptomatic relief of severe dry eye syndrome ( DES ) , as compared to conventional preservative-free artificial tears ( PFAT ) .
METHODS	This prospective double-blind randomized crossover study used the Ocular Surface Disease Index ( OSDI ) , tear film break-up time ( TBUT ) , Schirmer 's Test , and OXFORD Scale at baseline and after each of two 1-month treatment periods to measure the effect of 20 % diluted AS eye drops vs. PFAT in 20 consecutive severe DES patients that were refractory to conventional treatment .
RESULTS	The study included 20 ( 18 female and two male ) severe DES patients ( 40 eyes ) .
RESULTS	Significantly higher TBUT ( P < 0.001 , Wilcoxon signed-rank test ) and a greater decrease in OSDI score ( 55.18 % decrease in the AS treatment group vs. 19.50 % decrease in the PFAT treatment group ) ( P < 0.001 , Student 's paired samples t-test ) were observed in the AS treatment group after 1 month of treatment .
RESULTS	There was n't a significant difference in Schirmer 's test and OXFORD conjunctival and corneal vital dying grading scores between the two treatment groups after 1 month of treatment ( P > 0.05 [ Mann-Whitney U test ] ) .
CONCLUSIONS	AS eye drops were more effective than conventional eye drops for improving tear film stability and subjective comfort in patients with severe DES .

###24330343
BACKGROUND	The maximum plasma concentration ( Cmax ) of oxymorphone extended release ( ER ) 20mg and 40mg is approximately 50 % higher in fed than in fasted subjects , with most of the difference in area-under-the-curve ( AUC ) occurring in the first 4 hours post-dose .
BACKGROUND	Hence , the US FDA recommends in the approved labeling that oxymorphone ER is taken at least 1 hour before or 2 hours after eating .
METHODS	In order to determine the potential impact on cognitive performance of the increased absorption of oxymorphone ER , fed versus fasting , we conducted a randomized , rater-blinded , crossover study in 30 opioid-tolerant subjects , using tests from the Cambridge Neuropsychological Test Automated Battery ( CANTAB ) .
METHODS	The subjects randomly received 40mg oxymorphone ER after a high-fat meal of approximately 1,010 kCal or after fasting for 8-12 hours , and were tested 1 hour and 3 hours post-dose .
RESULTS	The CANTAB tests , Spatial Recognition Memory ( SRM ) and Spatial Working Memory ( SWM ) , showed no statistically significant differences between the fed and fasting conditions .
RESULTS	However , sustained attention , as measured by the Rapid Visual Information Processing ( RVP ) CANTAB test , showed a statistically significant interaction of fed versus fasting and post-dose time of testing ( F [ 1,28 ] = 6.88 , P = 0.01 ) , suggesting that 40mg oxymorphone ER after a high-fat meal versus fasting mitigates the learning effect in this particular cognition domain from 1 hour to 3 hours post-dose .
CONCLUSIONS	Oxymorphone 40mg ER affected cognitive performance similarly within 3 hours post-dose , whether given on an empty stomach or after a high-fat meal , suggesting that the effect of food on plasma concentration may not be relevant in the medication 's impact on cognition .

###25499543
BACKGROUND	Supplementation of vitamin A in children aged 6-59 months improves child survival and is implemented as global policy .
BACKGROUND	Studies of the efficacy of supplementation of infants in the neonatal period have inconsistent results .
BACKGROUND	We aimed to assess the efficacy of oral supplementation with vitamin A given to infants in the first 3 days of life to reduce mortality between supplementation and 180 days ( 6 months ) .
METHODS	We did an individually randomised , double-blind , placebo-controlled trial of infants born in the Morogoro and Dar es Salaam regions of Tanzania .
METHODS	Women were identified during antenatal clinic visits or in the labour wards of public health facilities in Dar es Salaam .
METHODS	In Kilombero , Ulanga , and Kilosa districts , women were seen at home as part of the health and demographic surveillance system .
METHODS	Newborn infants were eligible for randomisation if they were able to feed orally and if the family intended to stay in the study area for at least 6 months .
METHODS	We randomly assigned infants to receive one dose of 50,000 IU of vitamin A or placebo in the first 3 days after birth .
METHODS	Infants were randomly assigned in blocks of 20 , and investigators , participants ' families , and data analysis teams were masked to treatment assignment .
METHODS	We assessed infants on day 1 and day 3 after dosing , as well as at 1 , 3 , 6 , and 12 months after birth .
METHODS	The primary endpoint was mortality at 6 months , assessed by field interviews .
METHODS	The primary analysis included only children who were not lost to follow-up .
METHODS	This trial is registered with the Australian New Zealand Clinical Trials Registry ( ANZCTR ) , number ACTRN12610000636055 .
RESULTS	Between Aug 26 , 2010 , and March 3 , 2013 , 31,999 newborn babies were randomly assigned to receive vitamin A ( n = 15,995 ) or placebo ( n = 16,004 ; 15,428 and 15,464 included in analysis of mortality at 6 months , respectively ) .
RESULTS	We did not find any evidence for a beneficial effect of vitamin A supplementation on mortality in infants at 6 months ( 26 deaths per 1000 livebirths in vitamin A vs 24 deaths per 1000 livebirths in placebo group ; risk ratio 110 , 95 % CI 095-126 ; p = 0193 ) .
RESULTS	There was no evidence of a differential effect for vitamin A supplementation on mortality by sex ; risk ratio for mortality at 6 months for boys was 108 ( 090-129 ) and for girls was 112 ( 091-139 ) .
RESULTS	There was also no evidence of adverse effects of supplementation within 3 days of dosing .
CONCLUSIONS	Neonatal vitamin A supplementation did not result in any immediate adverse events , but had no beneficial effect on survival in infants in Tanzania .
CONCLUSIONS	These results strengthen the evidence against a global policy recommendation for neonatal vitamin A supplementation .
BACKGROUND	Bill & Melinda Gates Foundation to WHO .

###24603565
OBJECTIVE	To estimate the effectiveness of different strategies involving delayed antibiotic prescription for acute respiratory tract infections .
METHODS	Open , pragmatic , parallel group , factorial , randomised controlled trial .
METHODS	Primary care in the United Kingdom .
METHODS	889 patients aged 3 years and over with acute respiratory tract infection , recruited between 3 March 2010 and 28 March 2012 by 53 health professionals in 25 practices .
METHODS	Patients judged not to need immediate antibiotics were randomised to undergo four strategies of delayed prescription : recontact for a prescription , post-dated prescription , collection of the prescription , and be given the prescription ( patient led ) .
METHODS	During the trial , a strategy of no antibiotic prescription was added as another randomised comparison .
METHODS	Analysis was intention to treat .
METHODS	Mean symptom severity ( 0-6 scale ) at days 2-4 ( primary outcome ) , antibiotic use , and patients ' beliefs in the effectiveness of antibiotic use .
METHODS	Secondary analysis included comparison with immediate use of antibiotics .
RESULTS	Mean symptom severity had minimal differences between the strategies involving no prescription and delayed prescription ( recontact , post-date , collection , patient led ; 1.62 , 1.60 , 1.82 , 1.68 , 1.75 , respectively ; likelihood ratio test ( 2 ) 2.61 , P = 0.625 ) .
RESULTS	Duration of symptoms rated moderately bad or worse also did not differ between no prescription and delayed prescription strategies combined ( median 3 days v 4 days ; 4.29 , P = 0.368 ) .
RESULTS	There were modest and non-significant differences in patients very satisfied with the consultation between the randomised groups ( 79 % , 74 % , 80 % , 88 % , 89 % , respectively ; likelihood ratio test ( 2 ) 2.38 , P = 0.667 ) , belief in antibiotics ( 71 % , 74 % , 73 % , 72 % , 66 % ; 1.62 , P = 0.805 ) , or antibiotic use ( 26 % , 37 % , 37 % , 33 % , 39 % ; 4.96 , P = 0.292 ) .
RESULTS	By contrast , most patients given immediate antibiotics used antibiotics ( 97 % ) and strongly believed in them ( 93 % ) , but with no benefit for symptom severity ( score 1.76 ) or duration ( median 4 days ) .
CONCLUSIONS	Strategies of no prescription or delayed antibiotic prescription result in fewer than 40 % of patients using antibiotics , and are associated with less strong beliefs in antibiotics , and similar symptomatic outcomes to immediate prescription .
CONCLUSIONS	If clear advice is given to patients , there is probably little to choose between the different strategies of delayed prescription .
BACKGROUND	ISRCTN38551726 .

###25997115
OBJECTIVE	To our knowledge , this is the first study to assess the potential to pharmacologically improve auditory function in adults with age-related sensorineural hearing loss .
OBJECTIVE	To explore the potential for the - amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid potentiator mechanism to affect auditory function in individuals with mild to moderate age-related sensorineural hearing loss .
METHODS	A randomized , double-blind , placebo-controlled , single-dose , 3-way crossover study was conducted in 3 academic ear , nose , and throat clinics and 2 private clinical research centers between December 22 , 2011 , and February 26 , 2013 .
METHODS	Participants were 50 - to 75-year-old men and women of nonchildbearing potential with mild to moderate sensorineural hearing loss .
METHODS	Three single doses of PF-04958242 , an - amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid glutamate-positive allosteric modulator , and placebo .
METHODS	Pure-tone average , speech discrimination score , and speech in noise testing change from baseline at 1 and 5 hours after a single dose of PF-04958242 .
RESULTS	The treatment was safe and well tolerated .
RESULTS	The estimates for the primary end point change from baseline in pure-tone average compared with placebo at 1 hour were -0.77 ( 95 % CI , -2.14 to 0.59 ) and 0.37 ( 95 % CI , -0.97 to 1.72 ) for 0.27 and 0.35 mg , respectively .
RESULTS	At 5 hours the estimates were -0.57 ( 95 % CI , -2.43 to 1.29 ) and -0.56 ( 95 % CI , -2.45 to 1.33 ) for 0.27 and 0.35 mg , respectively .
RESULTS	No significant change from baseline was demonstrated compared with placebo in the primary or secondary study end points at 1 or 5 hours after receiving treatment .
CONCLUSIONS	To our knowledge , this clinical trial is the first study of a pharmacologic treatment for age-related sensorineural hearing loss and provides information with regard to study design , end points , variability , data characteristics , and operational feasibility to guide the design of future hearing loss trials .
BACKGROUND	clinicaltrials.gov Identifier : NCT01518920 .

###24377666
OBJECTIVE	Kendall suggests testing the rotator cuff muscles in their maximally shortened position , since one-joint muscles are thought to be strongest .
OBJECTIVE	We found little evidence to support this concept .
OBJECTIVE	The purpose of this study was to determine if the shoulder internal rotator ( IR ) and external rotator ( ER ) muscles are strongest when placed in their shortened length position .
METHODS	Fifty-three subjects participated .
METHODS	Glenohumeral joint internal rotation and external rotation motion was measured .
METHODS	Muscle strength was then tested using a hand-held dynamometer in four positions : ( 1 ) end-range ER ; ( 2 ) neutral 0 ; ( 3 ) glenohumeral joint mid-range and ( 4 ) end-range IR .
METHODS	Data were analyzed using two repeated measures ANOVA 's .
RESULTS	The results suggest that rotator muscle strength is dependent on muscle length .
RESULTS	IR strength was weakest at end-range IR in its shortest length ; ER muscle strength was weakest at end-range ER in its shortest length .
RESULTS	Muscle strength of the IR or ER was not significantly different when comparing neutral 0 to the mid-range position and at their most lengthened position .
CONCLUSIONS	The IR and ER muscles were found to be weakest when placed in a position of shortest muscle length , while the neutral 0 and mid-range positions were the strongest positions .

###25714534
OBJECTIVE	To compare the anesthetic effectiveness of topical proparacaine drops , subconjunctival lidocaine , and 2 % lidocaine gel .
METHODS	Ninety-two patients undergoing intravitreal injections were randomized to 1 of 3 groups : proparacaine 0.5 % drops ( Group Drops ) , proparacaine 0.5 % drops plus subconjunctival lidocaine ( Group SC ) , or 2 % lidocaine gel ( Group Gel ) .
METHODS	Patients were asked to score their pain experience using a visual analog scale of 0 to 10 immediately following the injections and 10 min , 1 h , 6 h , and 24 h after the injections .
METHODS	Patients also graded the overall injection experience as Excellent , Very Good , Fair , Poor , or Awful .
METHODS	The physician evaluated the patients ' eye movement during intravitreal injection on 3 levels : ( 0 ) none or minimal , ( 1 ) not compromising the injection , and ( 2 ) compromising the injection .
RESULTS	The patients in Group Drops had the worst mean pain scores during the injection and 10 min after , with the highest occurrence of movements compromising the procedure ( Grade 2 ; 38.7 % ) .
RESULTS	The patients in Group SC had a higher percentage of good experiences ( 37.9 % ) but a higher incidence of chemosis ( 16.7 % ) .
RESULTS	The patients in Group Gel had similar overall pain scores to Group Drops patients but a higher incidence of keratitis ( 19.4 % ) .
RESULTS	There was no statistically significant correlation between the use of aspirin or anticoagulants and the occurrence of hyperemia or hyposphagma .
CONCLUSIONS	Subconjunctival lidocaine was most effective in preventing pain and eye movements during intravitreal injections .
CONCLUSIONS	Although 2 % lidocaine gel produced a good overall experience for the patients , the incidence of keratitis was very high ( 19.4 % ) .
CONCLUSIONS	Therefore , we do not recommend 2 % lidocaine gel as the first anesthetic choice for intravitreal injections .
CONCLUSIONS	There is no evidence to suspend the use of aspirin or other anticoagulants drugs prior to intravitreal injections .

###24836472
BACKGROUND	Oral flora , blood-borne pathogens , and bacterial contamination pose a direct risk of infection to patients and health care workers .
BACKGROUND	We conducted a study in a simulated operating room using a newly validated technology to determine whether the use of 2 sets of gloves , with the outer set removed immediately after endotracheal intubation , may reduce this risk .
METHODS	Forty-one anesthesiology residents ( PGY 2-4 ) were enrolled in a study consisting of individual or group simulation sessions .
METHODS	On entry to the simulated operating room , the residents were asked to perform an anesthetic induction and tracheal intubation timed to approximately 6 minutes ; they were unaware of the study design .
METHODS	Of the 22 simulation sessions , 11 were conducted with the intubating resident wearing single gloves , and 11 with the intubating resident using double gloves with the outer pair removed after verified intubation .
METHODS	Before the start of the scenario , we coated the lips and inside of the mouth of the mannequin with a fluorescent marking gel as a surrogate pathogen .
METHODS	After the simulation , an observer examined 40 different sites using a handheld ultraviolet light in the operating room to determine the transfer of surrogate pathogens to the patient and the patient 's environment .
METHODS	Residents who wore double gloves were instructed by a confederate nurse to remove the outer set immediately after completion of the intubation .
METHODS	Forty sites of potential intraoperative pathogen spread were identified and assigned a score .
RESULTS	The difference in the rate of contamination between anesthesiology residents who wore single gloves versus those with double gloves was clinically and statistically significant .
RESULTS	The number of sites that were contaminated in the operating room when the intubating resident wore single gloves was 20.3 1.4 ( mean SE ) ; the number of contaminated sites when residents wore double gloves was 5.0 0.7 ( P < 0.001 ) .
CONCLUSIONS	The results of this study suggest that when an anesthesiologist wears 2 sets of gloves during laryngoscopy and intubation and then removes the outer set immediately after intubation , the contamination of the intraoperative environment is dramatically reduced .

###24681658
BACKGROUND	Little is known about thermoregulation of the newborn while bonding on the mother 's chest immediately after cesarean delivery .
BACKGROUND	Newborn hypothermia is associated with serious complications and should be avoided .
BACKGROUND	Therefore , we evaluated whether newborns develop hypothermia during intraoperative bonding while positioned on their mothers ' chests and investigated the effects of active cutaneous warming of the mothers and babies during a 20-minute intraoperative bonding period .
METHODS	We enrolled 40 parturients scheduled for elective cesarean delivery under spinal anesthesia .
METHODS	Mothers and their newborns were randomized to receive either passive insulation or forced-air skin-surface warming during the surgical procedure and bonding period .
METHODS	The primary outcome was neonatal core temperature at the end of the bonding period .
METHODS	Core temperatures of the newborns were measured with a rectal probe .
METHODS	Body temperatures of the mothers were assessed by sublingual measurements .
METHODS	Skin temperatures , thermal comfort of the mothers , and perioperative shivering were evaluated .
RESULTS	Without active warming from the beginning of the surgical procedure until the end of the bonding period , the mean ( SD ) neonatal core temperature decreased to 35.9 ( 0.6 ) C. Seventeen of 21 ( 81 % ) newborns became hypothermic ( defined as a core temperature below 36.5 C ) .
RESULTS	Active skin-surface warming from the beginning of the surgical procedure until the end of the bonding period resulted in a neonatal core temperature of 37.0 ( 0.2 ) C and a decreased incidence of hypothermia ( 1 of 19 ( 5 % ) newborns ( P < 0.0001 ) ) .
RESULTS	In addition , active warming increased the mean skin temperatures of the infants , maternal core and skin temperatures , maternal thermal comfort , and reduced perioperative shivering .
CONCLUSIONS	Active forced-air warming of mothers and newborns immediately after cesarean delivery reduces the incidence of infant and maternal hypothermia and maternal shivering , and increases maternal comfort .

###24886225
BACKGROUND	Several feasibility studies show promising results of telehealthcare on health outcomes and health-related quality of life for patients suffering from chronic obstructive pulmonary disease , and some of these studies show that telehealthcare may even lower healthcare costs .
BACKGROUND	However , the only large-scale trial we have so far - the Whole System Demonstrator Project in England - has raised doubts about these results since it conclude that telehealthcare as a supplement to usual care is not likely to be cost-effective compared with usual care alone .
METHODS	The present study is known as ` TeleCare North ' in Denmark .
METHODS	It seeks to address these doubts by implementing a large-scale , pragmatic , cluster-randomized trial with nested economic evaluation .
METHODS	The purpose of the study is to assess the effectiveness and the cost-effectiveness of a telehealth solution for patients suffering from chronic obstructive pulmonary disease compared to usual practice .
METHODS	General practitioners will be responsible for recruiting eligible participants ( 1,200 participants are expected ) for the trial in the geographical area of the North Denmark Region .
METHODS	Twenty-six municipality districts in the region define the randomization clusters .
METHODS	The primary outcomes are changes in health-related quality of life , and the incremental cost-effectiveness ratio measured from baseline to follow-up at 12 months .
METHODS	Secondary outcomes are changes in mortality and physiological indicators ( diastolic and systolic blood pressure , pulse , oxygen saturation , and weight ) .
CONCLUSIONS	There has been a call for large-scale clinical trials with rigorous cost-effectiveness assessments in telehealthcare research .
CONCLUSIONS	This study is meant to improve the international evidence base for the effectiveness and cost-effectiveness of telehealthcare to patients suffering from chronic obstructive pulmonary disease by implementing a large-scale pragmatic cluster-randomized clinical trial .
BACKGROUND	Clinicaltrials.gov , http://NCT01984840 , November 14 , 2013 .

###24801644
BACKGROUND	Choosing the right infusion set site can be an important factor in obtaining good glycemic control , especially in very young children .
BACKGROUND	In an attempt to identify the best infusion site , we performed a crossover study in six preschool children with type 1 diabetes using insulin pump therapy .
METHODS	We enrolled six patients 5.20.7 years old ( range , 4-6 years ) , with type 1 diabetes for more than 1.5 years , using insulin pump therapy for at least 6 months .
METHODS	For each patient , body mass index , glycated hemoglobin , and all data downloaded from the system were evaluated on two occasions : the first with the infusion set placed on the buttock and the second on the abdomen , each for 3 days .
METHODS	The order of infusion set placement was randomized .
METHODS	Mean capillary blood glucose , mean continuous glycemia , mean area under the curve ( AUC ) using the trapezoidal rule for both > 140mg/dL and < 70mg/dL , insulin daily dose , carbohydrate/insulin ratio , total basal insulin , total bolus insulin , and mean amplitude of glucose excursions ( MAGE ) were evaluated .
RESULTS	Mean glycemic values , mean AUC > 140mg/dL , and MAGE were significantly lower when the infusion set was placed on the buttock versus the abdomen ( 144.631.9 mg/dL vs. 166.034.8 mg/dL [ P = 0.000 ] , 28.418.3 % vs. 48.828.2 % [ P = 0.000 ] , and 3210 vs. 6015mg/dL [ P < 0.001 ] , respectively ) , whereas mean AUC < 70mg/dL was higher ( 1.472.77 % vs. 0.871.03 % [ P < 0.001 ] ) .
CONCLUSIONS	The present findings suggest that preschool children with type 1 diabetes using insulin pump therapy could benefit from inserting the infusion set in the buttock instead of the abdomen .

###24637999
OBJECTIVE	To evaluate risk factors for GI adverse events ( AEs ) within a phase III trial of bevacizumab in first-line ovarian cancer therapy .
METHODS	Women with previously untreated advanced disease after surgery were randomly allocated to six cycles of platinum-taxane chemotherapy plus placebo cycles ( C ) 2 to C22 ( R1 ) ; chemotherapy plus bevacizumab C2 to C6 plus placebo C7 to C22 ( R2 ) ; or chemotherapy plus bevacizumab C2 to C22 ( R3 ) .
METHODS	Patients were evaluated for history or on-study development of potential risk factors for GI AEs defined as grade 2 perforation , fistula , necrosis , or hemorrhage .
RESULTS	Of 1,873 patients enrolled , 1,759 ( 94 % ) were evaluable , and 2.8 % ( 50 of 1,759 ) experienced a GI AE : 10 of 587 ( 1.7 % , R1 ) , 20 of 587 ( 3.4 % , R2 ) , and 20 of 585 ( 3.4 % , R3 ) .
RESULTS	Univariable analyses indicated that previous treatment of inflammatory bowel disease ( IBD ; P = .005 ) and small bowel resection ( SBR ; P = .032 ) or large bowel resection ( LBR ; P = .012 ) at primary surgery were significantly associated with a GI AE .
RESULTS	The multivariable estimated relative odds of a GI AE were 13.4 ( 95 % CI , 3.44 to 52.3 ; P < .001 ) for IBD ; 2.05 ( 95 % CI , 1.09 to 3.88 ; P = .026 ) for LBR ; 1.95 ( 95 % CI , 0.894 to 4.25 ; P = .093 ) for SBR ; and 2.15 for bevacizumab exposure ( aggregated 95 % CI , 1.05 to 4.40 ; P = .036 ) .
CONCLUSIONS	History of treatment for IBD , and bowel resection at primary surgery , increase the odds of GI AEs in patients receiving first-line platinum-taxane chemotherapy for advanced ovarian cancer .
CONCLUSIONS	After accounting for these risk factors , concurrent bevacizumab doubles the odds of a GI AE , but is not appreciably increased by continuation beyond chemotherapy .

###25891697
BACKGROUND	Compliance with immunosuppressive regimens may affect clinical outcomes in renal transplant recipients .
BACKGROUND	The aim of this study was to assess the safety and efficacy of standard-dose tacrolimus modified-release ( TAC-MR ) once daily versus tacrolimus ( TAC ) twice daily in stable renal transplant recipients .
METHODS	Ninety-nine stable renal transplant recipients were randomized to receive standard-dose tacrolimus twice daily or standard-dose modified-release tacrolimus once daily on a 1:1 ( mg : mg ) basis .
METHODS	The primary end point was the incidence of adverse events ( AEs ) in both groups .
METHODS	Secondary end points included biopsy-proven acute rejection , graft survival , patient survival , clinical indicators , and change in score of questionnaire .
RESULTS	The incidence of AEs was not different between the TAC and TAC-MR groups ( 56.0 % vs 53.1 % , P > .05 ) .
RESULTS	There were no significant differences in mean calculated glomerular filtration rate , blood pressure , glycosylated hemoglobulin ( HbA1c ) , blood concentration of tacrolimus , and drug compliance .
RESULTS	The scores of all items in the 36-item short form health survey ( SF-36 ) were not different between groups , except for vitality .
RESULTS	With respect to the subject questionnaire , there was no difference in question scores between the two treatment groups .
CONCLUSIONS	A regimen of TAC-MR once daily can be considered as an effective and safe alternative formulation of tacrolimus in stable renal transplant patients .

###24961730
OBJECTIVE	To evaluate the possible renal and hepatic toxicity of tepoxalin in dogs exposed to hypotension during isoflurane anesthesia .
METHODS	Prospective , randomized experimental study .
METHODS	Twenty adult mixed-breed dogs , weighing 18.82.8 kg .
METHODS	The animals received 10mgkg ( -1 ) tepoxalin orally 2hours before the anesthetic procedure ( PRE ; n = 6 ) , or 30minutes after anesthesia ( POST ; n = 6 ) , along with a control group ( CON ; n = 8 ) , which were only anesthetized .
METHODS	The PRE and POST groups also received the same dose of tepoxalin for 5days post-procedure .
METHODS	All dogs were anesthetized with propofol and maintained with isoflurane and the end-tidal isoflurane ( Fe'Iso ) was increased until mean arterial pressure decreased to 50-60mmHg .
METHODS	These pressures were maintained for 60minutes .
METHODS	Heart rate , arterial pressures and Fe'Iso were recorded at 0 , 10 and every 10minutes up to 60minutes of hypotension .
METHODS	Blood gases , pH , electrolytes and bleeding time were analyzed before and at 30 and 60minutes of hypotension .
METHODS	Renal and hepatic changes were quantified by serum and urinary biochemistry and creatinine clearance .
RESULTS	Serum concentrations of alanine amino transferase ( ALT ) , alkaline phosphatase ( ALP ) and - glutamyl transferase ( GGT ) , blood urea nitrogen ( BUN ) and creatinine ( Cr ) , and urinary output , urinary Cr , Cr clearance , and GGT : Cr ratio remained stable throughout the evaluations .
RESULTS	During the anesthetic procedure there were no important variations in the physiological parameters .
RESULTS	No side effects were observed in any of the groups .
CONCLUSIONS	Tepoxalin did not cause significant effects on renal function or cause hepatic injury in healthy dogs exposed to hypotension with isoflurane , when administered pre - or postanesthetic and continued for five consecutive days .

###24881861
BACKGROUND	An exploratory analysis of the German Off Pump Coronary Artery Bypass Grafting in Elderly Patients ( GOPCABE ) trial was performed to investigate the effect of off-pump coronary artery bypass grafting ( CABG ) on kidney function after the operation .
METHODS	Data on kidney function were available from 1,612 patients , representing 67 % of the study population .
METHODS	Preoperative kidney function was graded according to the glomerular filtration rate .
METHODS	Acute kidney injury ( AKI ) within the first week after the operation was defined and classified according to the Acute Kidney Injury Network ( AKIN ) criteria .
METHODS	The incidence and severity of AKI was compared between patients operated on on-pump or off-pump .
RESULTS	Impaired kidney function was seen in 642 patients ( 40 % ) , and 19 patients had preexisting end-stage kidney disease .
RESULTS	AKI of any severity occurred in half of all patients undergoing CABG , with AKIN stage 1 accounting for most of the cases .
RESULTS	The incidence and severity of AKI in patients undergoing on-pump vs off-pump CABG was AKIN stage 1 : 298 ( 37 % ) vs 329 ( 42 % ) ; AKIN stage 2 : 38 ( 5 % ) vs 43 ( 5 % ) ; and AKIN stage 3 : 44 ( 6 % ) vs 44 ( 6 % ) , which did not differ significantly ( p = 0.174 ) .
RESULTS	New renal replacement therapy was necessary in 3.2 % ( on-pump ) and in 2.7 % ( off-pump ) of all patients .
RESULTS	Stratification according to preoperative kidney function yielded comparable frequencies of AKI for on-pump and off-pump CABG .
CONCLUSIONS	AKI was common in elderly patients undergoing CABG , but deterioration of kidney function requiring renal replacement therapy was a rare event .
CONCLUSIONS	Off-pump CABG was not associated with decreased rates or reduced severity of AKI in elderly patients .

###25083017
OBJECTIVE	Obstructive sleep apnea ( OSA ) diagnosis using simplified methods such as portable sleep monitoring ( PM ) is only recommended in patients with a high pretest probability .
OBJECTIVE	The aim is to determine the diagnostic efficacy , consequent therapeutic decision-making , and costs of OSA diagnosis using polysomnography ( PSG ) versus three consecutive studies of PM in patients with mild to moderate suspicion of sleep apnea or with comorbidity that can mask OSA symptoms .
METHODS	Randomized , blinded , crossover study of 3 nights of PM ( 3N-PM ) versus PSG .
METHODS	The diagnostic efficacy was evaluated with receiver operating characteristic ( ROC ) curves .
METHODS	Therapeutic decisions to assess concordance between the two different approaches were performed by sleep physicians and respiratory physicians ( staff and residents ) using agreement level and kappa coefficient .
METHODS	The costs of each diagnostic strategy were considered .
RESULTS	Fifty-six patients were selected .
RESULTS	Epworth Sleepiness Scale was 10.1 ( 5.3 ) points .
RESULTS	Bland-Altman plot for apnea-hypopnea index ( AHI ) showed good agreement .
RESULTS	ROC curves showed the best area under the curve in patients with PSG AHI 5 [ 0.955 ( confidence interval = 0.862-0 .993 ) ] .
RESULTS	For a PSG AHI 5 , a PM AHI of 5 would effectively exclude and confirm OSA diagnosis .
RESULTS	For a PSG AHI 15 , a PM AHI 22 would confirm and PM AHI < 7 would exclude OSA .
RESULTS	The best agreement of therapeutic decisions was achieved by the sleep medicine specialists ( 81.8 % ) .
RESULTS	The best cost-diagnostic efficacy was obtained by the 3N-PM .
CONCLUSIONS	Three consecutive nights of portable monitoring at home evaluated by a qualified sleep specialist is useful for the management of patients without high pretest probability of obstructive sleep apnea or with comorbidities .
BACKGROUND	http://www.clinicaltrials.gov , registration number : NCT01820156 .
BACKGROUND	Guerrero A , Embid C , Isetta V , Farre R , Duran-Cantolla J , Parra O , Barb F , Montserrat JM , Masa JF .
BACKGROUND	Management of sleep apnea without high pretest probability or with comorbidities by three nights of portable sleep monitoring .

###25670364
BACKGROUND	Low high-density lipoprotein cholesterol ( HDL-C ) is a risk factor for coronary artery disease .
BACKGROUND	Investigating mechanisms underlying acquired severe HDL deficiency in noncritically ill patients ( `` disappearing HDL syndrome '' ) could provide new insights into HDL metabolism .
OBJECTIVE	To determine the cause of low HDL-C in patients with severe acquired HDL deficiency .
RESULTS	Patients with intravascular large B-cell lymphoma ( n = 2 ) , diffuse large B-cell lymphoma ( n = 1 ) , and autoimmune lymphoproliferative syndrome ( n = 1 ) presenting with markedly decreased HDL-C , low low-density lipoprotein cholesterol ( LDL-C ) , and elevated triglycerides were identified .
RESULTS	The abnormal lipoprotein profile returned to normal after therapy in all 4 patients .
RESULTS	All patients were found to have markedly elevated serum interleukin-10 ( IL-10 ) levels that also normalized after therapy .
RESULTS	In a cohort of autoimmune lymphoproliferative syndrome patients ( n = 93 ) , IL-10 showed a strong inverse correlation with HDL-C ( R ( 2 ) = 0.3720 , P < .0001 ) .
RESULTS	A direct causal role for increased serum IL-10 in inducing the observed changes in lipoproteins was established in a randomized , placebo-controlled clinical trial of recombinant human IL-10 in psoriatic arthritis patients ( n = 18 ) .
RESULTS	Within a week of initiating subcutaneous recombinant human IL-10 injections , HDL-C precipitously decreased to near-undetectable levels .
RESULTS	LDL-C also decreased by more than 50 % ( P < .0001 ) and triglycerides increased by approximately 2-fold ( P < .005 ) .
RESULTS	All values returned to baseline after discontinuing IL-10 therapy .
CONCLUSIONS	Increased IL-10 causes severe HDL-C deficiency , low LDL-C , and elevated triglycerides .
CONCLUSIONS	IL-10 is thus a potent modulator of lipoprotein levels , a potential new biomarker for B-cell disorders , and a novel cause of disappearing HDL syndrome .

###24632279
OBJECTIVE	The aim of this study was to investigate whether baseline lesion complexity affects drug-eluting stent ( DES ) outcomes according to diabetic status .
BACKGROUND	Previous studies have reported conflicting results regarding DES safety and efficacy in patients with and without diabetes mellitus ( DM ) .
METHODS	Patient-level data from 18 prospective randomized trials were pooled .
METHODS	DES treatment outcomes in patients with versus without DM were analyzed in 2 propensity score-matched groups further stratified according to lesion complexity ( American College of Cardiology and American Heart Association class A/B1 vs. B2/C ) .
METHODS	Remaining baseline differences were adjusted for by multivariate analysis .
RESULTS	DM was present in 3,467 of 18,441 patients ( 18.8 % ) .
RESULTS	DM was a predictor of 1-year repeat revascularization ( target lesion revascularization : hazard ratio : 1.34 ; 95 % confidence interval : 1.05 to 1.70 ; target vessel revascularization : hazard ratio : 1.40 ; 95 % confidence interval : 1.15 to 1.72 ) and cardiac death or myocardial infarction ( hazard ratio : 1.40 ; 95 % confidence interval : 1.09 to 1.81 ) .
RESULTS	Rates of target lesion and target vessel revascularization were significantly higher in patients with versus those without DM with type B2/C lesions ( 8.0 % vs. 4.5 % and 10.6 % vs. 5.9 % , respectively , p < 0.0001 for both ) , but not in patients with only type A/B1 lesions ( 4.6 % vs. 4.8 % , p = 0.87 , and 7.4 % vs. 6.8 % , p = 0.47 , respectively ) , with a significant interaction between DM and lesion type observed for both endpoints ( p = 0.01 and p = 0.02 , respectively ) .
RESULTS	No interaction was observed for death or myocardial infarction ( p = 0.28 ) .
CONCLUSIONS	In the DES era , patients with DM remain at increased risk for cardiac death or myocardial infarction .
CONCLUSIONS	However , DM is a risk factor for repeat revascularization only in those patients with complex lesions ; patients with DM and noncomplex lesions have similar rates of 1-year freedom from repeat revascularization as do patients without DM .

###25091346
BACKGROUND	Data on the benefits of synbiotics in functional constipation are conflicting .
BACKGROUND	The aim of this study was to assess whether the administration of the synbiotic supplement Psyllogel Megafermenti ( ) normalized stool consistency and decreased intestinal transit time ( ITT ) in patients with severe functional constipation , based on its ability to impact on the gut microbiota .
METHODS	We conducted a pilot randomized , double-blind , controlled trial .
METHODS	After a 2-week run-in period , patients from a tertiary care setting with severe functional constipation fulfilling the Rome III Diagnostic Criteria in the past year were randomly assigned to receive by mouth 2 bags/day of Psyllogel Megafermenti ( ) ( Group A ) or 2.8 g of maltodextrin twice daily ( Group B ) for 8 weeks .
METHODS	Primary endpoints were increase of bowel evacuations with normal stool consistency and volume , and ITT reduction .
METHODS	Secondary endpoints included symptom improvement according to the Rome III Diagnostic Criteria , reduction of the Agachan-Wexner score and changes in gut microbiota composition .
RESULTS	Twenty-nine patients completed the study : 17 were allocated to Group A and 12 to Group B.
RESULTS	A statistically significant increase in stools with normal consistency was observed only in Group A ( p = 0.001 ) , even when considering patients with normal stools 50 % of time at baseline .
RESULTS	In Group A , a significant reduction in ITT was also found ( p = 0.022 ) .
RESULTS	According to polymerase chain reaction-denaturing gradient gel electrophoresis profiling of stool samples , 50 % of the patients treated with synbiotics harbored all the probiotic species of the study product .
CONCLUSIONS	An 8-week treatment with Psyllogel Megafermenti ( ) improved the main clinical parameters of functional constipation in patients extremely homogeneous for disorder severity and underlying pathophysiology ( Eudract.ema.europa.eu , No. 2008-000913-30 ) .

###24785926
BACKGROUND	In orthodontics , adding restorative materials on occlusal or lingual surfaces is a common method to create a mini-biteplane to increase patients ' vertical dimension temporarily to facilitate several treatment procedures .
BACKGROUND	However , this method transmits excessive occlusal forces through the periodontal ligament and causes trauma .
BACKGROUND	In this prospective randomized clinical trial , we measured and compared quantitatively the volumes of root resorption after 4 weeks of occlusal trauma .
METHODS	Forty-eight maxillary and mandibular first premolars of 12 patients ( 6 girls , 6 boys ) comprised the sample for this study .
METHODS	One side of each patient was randomly selected as the control .
METHODS	On the contralateral side , a light-cured glass ionomer cement ( Transbond Plus Light Cure Band Adhesive ; 3M Unitek , Monrovia , Calif ) was bonded onto the occlusal surface of the mandibular first premolar so that the cement was in contact with the maxillary first premolar .
METHODS	After 4 weeks , both first premolars were extracted .
METHODS	Each sample was imaged using a microcomputed tomography system ( 1172 ; SkyScan , Aartselaar , Belgium ) and analyzed with specially designed software for volumetric measurements of resorption craters .
METHODS	Furthermore , pain was evaluated with a visual analog scale for 7 days .
RESULTS	There were significant differences in the amounts of root resorption between the control and the experimentally traumatized teeth .
RESULTS	No significant difference among the buccal , lingual , mesial , and distal surfaces was found in either jaw .
RESULTS	Furthermore , no significant difference existed in the amount of root resorption among the cervical , middle , and apical thirds of both jaws .
RESULTS	There was no correlation between age , sex , volume of the root resorption craters , and pain .
CONCLUSIONS	Restorative buildups , used to increase the vertical dimension by 2 mm for 4 weeks , caused root resorption along the sides of the teeth during the active bite-increase period .

###24857251
BACKGROUND	The effect profile of differing antihypertensive agents is well studied , but minimal data regarding the interaction between hemodynamic response and presenting blood pressure ( BP ) exist .
OBJECTIVE	Achievement of target BP is less likely in patients with higher initial BPs .
METHODS	This is a substudy of the multicenter safety and efficacy Evaluation of intravenous Cardene ( nicardipine ) and Labetalol Use in the Emergency department ( CLUE ) trial that randomized patients to Food and Drug Administration-recommended intravenous dosing of nicardipine or labetalol to reach a physician predefined systolic BP ( SBP ) and target range ( TR ) of 20 mm Hg within 30 minutes .
METHODS	The proportion achieving TR was assessed as a function of initial SBP , and dichotomized comparisons were made using median SBP .
METHODS	Likelihood of a final BP within TR was modeled using logistic regression with forced inclusion of initial BP as a categorical variable .
RESULTS	A total 223 patients were enrolled ; 115 ( 51.6 % ) had an initial SBP greater than the median 202 mm Hg .
RESULTS	The median SBP ( interquartile range ) of the high BP group was 218 ( 210-228 ) mm Hg vs the low BP group 190 ( 182-197 ) mm Hg ( P < 0.0001 ) .
RESULTS	No groupwise differences existed except that the high group had higher mean ( SD ) serum creatinine level at baseline ( 3.1 [ 3.9 ] vs 1.9 [ 2.3 ] , P = .008 ) .
RESULTS	The proportion of patients achieving SBP within TR at 30 minutes did not differ ( 85.2 % [ 98 of 115 ] vs 88.9 % [ 96 of 108 ] , P = .42 ) .
RESULTS	Randomization to nicardipine ( odds ratio = 2.85 ; 95 % confidence interval , 1.16-7 .01 ) , but not initial SBP ( odds ratio = 0.60 ; 95 % confidence interval , 0.25-1 .44 ) , was associated with achievement of target SBP at 30 minutes .
CONCLUSIONS	Initial SBP is not a predictor of the ability to achieve a prespecified target range SBP within 30 minutes .

###25137425
BACKGROUND	High-density lipoproteins ( HDLs ) from type 2 diabetic patients are unable to counteract the inhibitory effect of oxidized low-density lipoproteins ( ox-LDLs ) on vasorelaxation .
BACKGROUND	We hypothesized that glitazones , which improve glycemic control and dyslipidemia , could correct this abnormality .
OBJECTIVE	We compared the ability of HDL from controls ( n = 12 ) and from type 2 diabetic patients before and after 6 months of treatment with either rosiglitazone ( n = 11 ) or pioglitazone ( n = 8 ) to counteract the inhibitory effect of ox-LDL on vasodilatation of rabbit aorta rings .
RESULTS	Rosiglitazone induced a decrease in hemoglobin A1c ( 7.7 % 1.1 % vs 9.8 % 1.0 % , P = .003 ) and an increase in HDL cholesterol ( 1.14 0.32 vs 0.98 0.24 mmol/L , P = .033 ) .
RESULTS	Pioglitazone induced a decrease in hemoglobin A1c ( 8.3 % 2.5 % vs 9.5 % 3.2 % , P = .068 ) and serum triglycerides ( 1.58 0.89 vs 2.03 0.70 mmol/L , P = .069 ) and an increase in HDL cholesterol ( 1.39 0.22 vs 1.14 0.22 mmol/L , P = .018 ) .
RESULTS	The triglyceride content of HDL was unchanged by rosiglitazone and was decreased by 25 % ( P = .068 ) by pioglitazone .
RESULTS	HDL from controls counteracted the inhibitory effect of ox-LDL on vasodilatation ( maximal relaxation [ Emax ] = 74.4 % 3.5 % vs 51.9 % 3.3 % , P = .0029 ) , whereas HDL from type 2 diabetic patients did not ( Emax = 51.7 % 5.8 % vs 52.3 % 4.6 % [ P = .66 ] and 52.7 % 5.5 % vs 51.9 % 4.5 % [ P = .78 ] for the rosiglitazone and pioglitazone group , respectively ) .
RESULTS	Rosiglitazone or pioglitazone did not improve Emax ( 58.6 % 5.9 % vs 52.3 % 4.6 % [ P = .15 ] and 49.3 % 6.5 % vs 51.9 % 4.5 % [ P = .48 ] , respectively ) .
CONCLUSIONS	Glitazones increased the concentration of HDL cholesterol without restoring the ability of HDL particles to protect the endothelium from oxidative stress-induced dysfunction , meaning that HDL remained dysfunctional with impaired antiatherogenic properties .

###26178889
BACKGROUND	Osteonecrosis of the femoral head frequently leads to collapse of the necrotic portion and subsequent degenerative joint disease of the hip , which is the most common diagnosis leading to total hip arthroplasty in young adults .
BACKGROUND	Bisphosphonate therapy has been reported to potentially retard the collapse .
BACKGROUND	We conducted a two-year prospective , randomized , open-label , multicenter study to determine whether zoledronate prevents the collapse and reduces the need for total hip arthroplasty .
METHODS	We randomly assigned patients who had Steinberg stage-I or II nontraumatic osteonecrosis of the femoral head with a necrotic area of 30 % to either the zoledronate group or the control group .
METHODS	Patients in the zoledronate group received 5 mg of zoledronate intravenously per year for two years , while patients in the control group did not receive this medication .
METHODS	The primary efficacy outcome was the survival rate in terms of the occurrence of collapse ( 2 mm ) .
METHODS	The patients were observed for a minimum of two years after enrollment .
RESULTS	A total of 110 patients ( 110 hips ) underwent randomization ; fifty-five patients were assigned to the zoledronate group and fifty-five , to the control group .
RESULTS	During the two-year follow-up , twenty-nine femoral heads in the zoledronate group and twenty-two in the control group collapsed ( p > 0.05 ) .
RESULTS	Nineteen hips in the zoledronate group and twenty in the control group underwent total hip arthroplasty ( p > 0.05 ) .
CONCLUSIONS	Zoledronate for Steinberg stage-I or II osteonecrosis of the femoral head , with a medium to large necrotic area , did not prevent the collapse of the femoral head or reduce the need for total hip arthroplasty .
METHODS	Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence .

###24469928
OBJECTIVE	Exposure , trauma-focused cognitive therapy and eye-movement desensitisation and re-processing ( EMDR ) are effective treatments for posttraumatic stress disorder ( PTSD ) producing equivalent outcomes .
OBJECTIVE	How might the field advance ?
OBJECTIVE	One way is to base new treatments on PTSD maintenance mechanisms .
OBJECTIVE	A treatment that does this , metacognitive therapy ( MCT ) , underwent preliminary controlled evaluation in this study .
METHODS	Twenty participants aged 18 to 65 years with chronic PTSD were randomly allocated to either a total of 8 sessions of MCT or a delayed treatment control .
METHODS	Measures of PTSD , emotional symptoms , and underlying metacognitive variables were obtained at pretreatment and posttreatment .
METHODS	Patients were followed-up at 3 and 6 months postintervention .
RESULTS	Statistically significant reductions in PTSD symptoms , depression , and anxiety at posttreatment were observed in the MCT group but not in the control group .
RESULTS	Changes were maintained over follow-up .
RESULTS	The average number of sessions delivered was 6.4 .
RESULTS	Eighty percent of patients ( intention to treat ) met clinical significance criteria for recovery based on the IES .
RESULTS	Treatment was well tolerated with only one ( 10 % ) dropout .
RESULTS	Changes in thought control strategy hypothesized to be involved in the maintenance of PTSD were found .
CONCLUSIONS	MCT appeared to be a brief treatment producing high recovery rates .
CONCLUSIONS	The data add to existing uncontrolled evaluations and provide strong justification for future evaluation of this treatment against existing evidence-based interventions .

###25312005
BACKGROUND	Much is to be learned about what implementation strategies are the most beneficial to communities attempting to adopt evidence-based practices .
BACKGROUND	This paper presents outcomes from a randomized implementation trial of Multidimensional Treatment Foster Care ( MTFC ) in child public service systems in California and Ohio , including child welfare , juvenile justice , and mental health .
METHODS	Fifty-one counties were assigned randomly to one of two different implementation strategies ( Community Development Teams ( CDT ) or independent county implementation strategy ( IND ) ) across four cohorts after being matched on county characteristics .
METHODS	We compared these two strategies on implementation process , quality , and milestone achievements using the Stages of Implementation Completion ( SIC ) ( Implement Sci 6 ( 1 ) :1 -8 , 2011 ) .
RESULTS	A composite score for each county , combining the final implementation stage attained , the number of families served , and quality of implementation , was used as the primary outcome .
RESULTS	No significant difference between CDT and IND was found for the composite measure .
RESULTS	Additional analyses showed that there was no evidence that CDT increased the proportion of counties that started-up programs ( i.e. , placed at least one family in MTFC ) .
RESULTS	For counties that did implement MTFC , those in the CDT condition served over twice as many youth during the study period as did IND. .
RESULTS	Of the counties that successfully achieved program start-up , those in the CDT condition completed the implementation process more thoroughly , as measured by the SIC .
RESULTS	We found no significant differences by implementation condition on the time it took for first placement , achieving competency , or number of stages completed .
CONCLUSIONS	This trial did not lead to higher rates of implementation or faster implementation but did provide evidence for more robust implementation in the CDT condition compared to IND implementation once the first family received MTFC services .
CONCLUSIONS	This trial was successful from a design perspective in that no counties dropped out , even though this study took place during an economic recession .
CONCLUSIONS	We believe that this methodologic approach of measurement utilizing the SIC , which is comprised of the three dimensions of quality , quantity , and timing , is appropriate for a wide range of implementation and translational studies .
BACKGROUND	Trial ID : NCT00880126 ( ClinicalTrials.gov ) .

###24380609
OBJECTIVE	To evaluate the efficacy of ampicillin versus cefazolin as prophylactic antibiotics prior to cesarean delivery in Rwanda .
METHODS	In a prospective , randomized , open-label , single-site study conducted between March and May 2012 , the effects of prophylactic ampicillin versus cefazolin were compared among women undergoing cesarean delivery at the Centre Hospitalier Universitaire de Kigali , Rwanda .
METHODS	Postoperatively , participants were evaluated daily for infectious morbidity while in the hospital .
METHODS	Follow-up was done by phone and by appointment at the hospital within 2 weeks of delivery .
RESULTS	During the study period , there were 578 total deliveries and 234 cesarean deliveries ( 40.4 % ) .
RESULTS	Overall , 132 women were enrolled in the study and randomized to receive either ampicillin ( n = 66 ) or cefazolin ( n = 66 ) .
RESULTS	No women were lost to follow-up .
RESULTS	The overall infection rate was 15.9 % ( 21/132 ) .
RESULTS	The infection rate in the ampicillin group and the cefazolin group was 25.8 % ( 17/66 ) and 6.1 % ( 4/66 ) , respectively .
CONCLUSIONS	Implementing a universal protocol in Rwanda of prophylactic cefazolin prior to cesarean delivery might reduce postoperative febrile morbidity , use of postoperative antibiotics , and number of postoperative days in hospital .

###25632575
OBJECTIVE	To observe the effect of acupuncture of Neiguan ( PC 6 ) , Sanyinjiao ( SP 6 ) , etc. on plasma lysophosphatidic acid ( LPA ) level in patients with acute cerebral infarction ( ACI ) so as to study its mechanism underlying improvement of ACI .
METHODS	A total of 160 patients with ACI were randomly divided into four groups : medication ( Aspirin and Panax Notoginseng Saponins for improving blood circulation ) , acupuncture , Tongxinluo , and acupuncture + Tongxinluo groups , with 40 cases being in each group .
METHODS	Plasma LPA content was measured using biochemical method , and the therapeutic effects of the 4 groups were assessed by neurologic deficit score which were evaluated using the modified standards of the 4Th Session of Chinese National Cerebrovascular Conference issued in 1995 .
RESULTS	Following the treatment , plasma LPA levels and neurological deficit scores were significantly decreased in the medication , acupuncture , Tongxinluo and acupuncture + Tongxinluo groups in com - parison with pre-treatment in each group ( P < 0.01 ) , and LPA level and neurological deficit score of the acupuncture + Tongxinluo group were significantly lower than those of the other three groups ( P < 0.01 ) .
RESULTS	Of the four 40 cases in the medication , acupuncture , Tongxinluo and acupuncture + Tongxinluo groups , 6 , 7 , 7 and 12 patients were basically cured , 9 , 8 , 9 and 18 experienced marked improvement in their symptoms , 14 , 16 , 15 and 6 were improved , 6 , 5 , 4 and 2 were invalid , 5 , 4 , 5 and 2 got worsened , with the effective rates ( basically cured + improvement ) being 37.5 % , 37.5 % , 40.0 % and 75.0 % , respectively .
RESULTS	The therapeutic effect of the acupuncture + Tongxinluo group was significantly superior to those of the other three groups ( P < 0.01 ) .
CONCLUSIONS	Acupuncture can accelerate the recovery of neurological function and ameliorate clinical symptoms in ACI patients , which may be related to its effect in lowering plasma PLA .
CONCLUSIONS	The therapeutic effect of acupuncture + Tongxinluo is relatively better than simple acupuncture and simple medication .

###24506950
BACKGROUND	Generalized Anxiety Disorder ( GAD ) , characterized by excessive and uncontrollable worry , has a negative impact on the health , well-being , and functioning of older adults .
BACKGROUND	Cognitive behavioral therapy has demonstrated efficacy in reducing anxiety and worry in older adults , but the generalizability of these findings to community-dwelling older adults is unknown .
BACKGROUND	The aim of the current study is to examine the efficacy of a cognitive-behavioral intervention delivered by telephone in reducing anxiety and worry in rural community-dwelling older adults with GAD .
METHODS	We propose a randomized controlled trial comparing telephone-delivered cognitive behavioral therapy ( CBT-T ) with nondirective supportive therapy ( NST-T ) .
METHODS	One hundred seventy six adults 60 years and older diagnosed with GAD will be randomized to one of the two treatment conditions .
METHODS	The primary outcomes are self-report worry and clinician-rated anxiety .
METHODS	Secondary outcomes include depressive symptoms , sleep , quality of life , and functional status .
CONCLUSIONS	It is hypothesized that CBT-T will be superior to NST-T in reducing anxiety and worry among older adults with GAD .
CONCLUSIONS	Further , CBT-T is hypothesized to be superior to NST-T in reducing problems with depressive symptoms , sleep , functional status and quality of life .
CONCLUSIONS	If this program is successful , it could be implemented as a low-cost program to treat late-life anxiety , especially in rural areas or in circumstances where older adults may not have access to qualified mental health providers .
BACKGROUND	clinicaltrials.gov Identifier : NCT01259596 .

###25632087
OBJECTIVE	To evaluate the ultrasound ( US ) characteristics of peripheral nerves in chronic inflammatory demyelinating polyradiculoneuropathy ( CIDP ) and their correlations with electrodiagnostic ( EDX ) characteristics .
METHODS	Nineteen patients with CIDP and 19 healthy controls matched by age and body mass index were included in a blind case-control , observational study .
METHODS	All patients underwent a neurologic examination ( including inflammatory neuropathy cause and treatment [ INCAT ] and Medical Research Council [ MRC ] sum score ) and an EDX study .
METHODS	Each patient and each control underwent a US study of 14 nerve segments , yielding a total number of 266 segments scanned in each group .
RESULTS	US changes , characterized by an increased nerve cross-sectional area ( NCSA ) , were detected in 53 % of the 266 patient nerve segments .
RESULTS	Mean NCSA was higher in nerve segments of patients than in those of controls ( p < 0.001 ) .
RESULTS	Nerve segments with abnormal US belonged to patients with longer disease duration , lower MRC sum score , higher INCAT score , and progressive disease form ( all p < 0.0001 ) .
RESULTS	All the aforementioned variables were independently associated with the occurrence of US changes .
RESULTS	Motor nerve conduction was significantly lower in nerve segments with increased NCSA than in those with normal NCSA ( p < 0.0001 ) .
RESULTS	NCSA in segments with prevalent myelin damage was higher than that in segments with prevalent axonal damage ( p = 0.001 ) or in segments with normal EDX characteristics ( p < 0.0001 ) .
RESULTS	NCSA and motor nerve conduction velocity were inversely correlated in nerve segments with EDX evidence of myelin damage ( R = 0.599 ; p < 0.0001 ) .
RESULTS	Conduction blocks were associated with increased NCSA ( p = 0.001 ) .
CONCLUSIONS	US may , similar to MRI , have a supporting role in the diagnosis of CIDP .
CONCLUSIONS	US and EDX changes are correlated .

###24508026
BACKGROUND	Vitamin D deficiency is associated with heart failure ( HF ) events , and in animal models vitamin D down-regulates renin-angiotensin-aldosterone system hormones .
METHODS	Patients with New York Heart Association ( NYHA ) functional class II-IV HF and a 25OH-D level 37.5 ng/mL received 50,000 IU vitamin D3 weekly ( n = 31 ) or placebo ( n = 33 ) for 6 months .
METHODS	Serum aldosterone , renin , echocardiography , and health status were determined at baseline and 6 months .
RESULTS	Mean age of participants was 65.9 10.4 years , 48 % were women , 64 % were African American , mean ejection fraction was 37.6 13.9 % , 36 % were in NYHA functional class III , and 64 % were in class II .
RESULTS	The vitamin D group increased serum 25OH-D ( 19.1 9.3 to 61.7 20.3 ng/mL ) and the placebo group did not ( 17.8 9.0 to 17.4 9.8 ng/mL ) .
RESULTS	Aldosterone decreased in the vitamin D group ( 10.0 11.9 to 6.2 11.6 ng/dL ) and not in the placebo group ( 8.9 8.6 to 9.0 12.4 ng/dL ; P = .02 ) .
RESULTS	There was no difference between groups in renin , echocardiographic measures , or health status from baseline to 6 months .
RESULTS	Modeling indicated that variables which predicted change in aldosterone included receiving vitamin D , increasing age , African American race , and lower glomerular filtration rate .
CONCLUSIONS	Vitamin D3 repletion decreases aldosterone in patients with HF and low serum vitamin D. Vitamin D may be an important adjunct to standard HF therapy .
CONCLUSIONS	Further study will assess if vitamin D provides long-term benefit for patients with HF .

###24952868
BACKGROUND	The purposes of this study were to identify nocturnal patterns of heart rate ( HR ) in depressed and nondepressed patients after an acute myocardial infarction ( MI ) and to determine which patterns , if any , are associated with all-cause mortality or recurrent infarction .
METHODS	Functional data analysis and model-based clustering methods were used to identify nocturnal HR patterns in 245 depressed and 247 nondepressed patients with a recent MI .
METHODS	All-cause mortality and recurrent infarctions were ascertained over a median follow-up of 24 months .
RESULTS	Three HR activity patterns were identified .
RESULTS	In the first , HR gradually declined during the nighttime and increased the next morning .
RESULTS	The second pattern was similar , but with a higher overall HR during the recording interval .
RESULTS	The third showed almost no decrease in HR at night ( ie , `` nondipping '' ) .
RESULTS	All-cause mortality was higher among patients with pattern 3 than pattern 1 ( P = .007 ) , and the combined end point of recurrent MI or all-cause mortality was higher in pattern 3 than pattern 2 ( P = .05 ) .
RESULTS	Patterns 2 and 3 were more common in the depressed than in the nondepressed patients .
CONCLUSIONS	The nondipping nocturnal HR independently predicts all-cause mortality and recurrent MI .
CONCLUSIONS	Future studies should examine the underlying causes of nondipping nocturnal HR and its association with depression and investigate the effects of treatment on survival .

###25667241
OBJECTIVE	Endothelial dysfunction is the first , although reversible , sign of atherosclerosis and is present in obese adolescents .
OBJECTIVE	The primary end point of this study was to investigate the influence of a multicomponent treatment on microvascular function .
OBJECTIVE	Additional objectives and end points were a reduced BMI SD score , improvements in body composition , exercise capacity , and cardiovascular risk factors , an increase in endothelial progenitor cells ( EPCs ) , and a decrease in endothelial microparticles ( EMPs ) .
METHODS	We used a quasi-randomized study with 2 cohorts of obese adolescents : an intervention group ( n = 33 ; 15.4 1.5 years , 24 girls and 9 boys ) treated residentially with supervised diet and exercise and a usual care group ( n = 28 ; 15.1 1.2 years , 22 girls and 6 boys ) , treated ambulantly .
METHODS	Changes in body mass , body composition , cardiorespiratory fitness , microvascular endothelial function , and circulating EPCs and EMPs were evaluated after 5 months and at the end of the 10-month program .
RESULTS	Residential intervention decreased BMI and body fat percentage , whereas it increased exercise capacity ( P < .001 after 5 and 10 months ) .
RESULTS	Microvascular endothelial function also improved in the intervention group ( P = .04 at 10 months ; + 0.59 0.20 compared with + 0.01 0.12 arbitrary units ) .
RESULTS	Furthermore , intervention produced a significant reduction in traditional cardiovascular risk factors , including high-sensitivity C-reactive protein ( P = .012 at 10 months ) .
RESULTS	EPCs were increased after 5 months ( P = .01 ) , and EMPs decreased after 10 months ( P = .004 ) .
CONCLUSIONS	A treatment regimen consisting of supervised diet and exercise training was effective in improving multiple adolescent obesity-related end points .

###24942012
BACKGROUND	Quantitative light intensity analysis of the strut core by optical coherence tomography ( OCT ) may enable assessment of changes in the light reflectivity of the bioresorbable polymeric scaffold from polymer to provisional matrix and connective tissues , with full disappearance and integration of the scaffold into the vessel wall .
BACKGROUND	The aim of this report was to describe the methodology and to apply it to serial human OCT images post procedure and at 6 , 12 , 24 and 36 months in the ABSORB cohort B trial .
RESULTS	In serial frequency-domain OCT pullbacks , corresponding struts at different time points were identified by 3-dimensional foldout view .
RESULTS	The peak and median values of light intensity were measured in the strut core by dedicated software .
RESULTS	A total of 303 corresponding struts were serially analyzed at 3 time points .
RESULTS	In the sequential analysis , peak light intensity increased gradually in the first 24 months after implantation and reached a plateau ( relative difference with respect to baseline [ % Dif ] : 61.4 % at 12 months , 115.0 % at 24 months , 110.7 % at 36 months ) , while the median intensity kept increasing at 36 months ( % Dif : 14.3 % at 12 months , 75.0 % at 24 months , 93.1 % at 36 months ) .
CONCLUSIONS	Quantitative light intensity analysis by OCT was capable of detecting subtle changes in the bioresorbable strut appearance over time , and could be used to monitor the bioresorption and integration process of polylactide struts .

###25702372
BACKGROUND	Many stroke survivors report participation challenges .
BACKGROUND	Occupational Performance Coaching for stroke survivors ( OPC-Stroke ) is designed to assist stroke survivors to develop the ability to plan and manage engagement in occupation .
BACKGROUND	This approach combines emotional support , individualized education , and goal-focused problem solving to promote occupational engagement .
OBJECTIVE	This study will explore the potential efficacy of OPC-Stroke and the feasibility of the research methods for use in a larger trial .
METHODS	A pilot randomized controlled trial will be undertaken .
METHODS	Participants will be randomly assigned to receive 10 sessions of OPC-Stroke or usual care .
METHODS	Participation , perceived goal performance , satisfaction and self-efficacy , emotional well-being , and cognition will be measured at three time points .
CONCLUSIONS	This research will test the potential usefulness of OPC-Stroke as well as the study methods , and thereby inform the continuing development of OPC-Stroke and further studies to measure its effectiveness .

###25199824
OBJECTIVE	The purpose of this study was to assess satisfaction with specific aspects of care for acute neck pain and explore the relationship between satisfaction with care , neck pain , and global satisfaction .
METHODS	This study was a secondary analysis of patient satisfaction from a randomized trial of spinal manipulation therapy ( SMT ) delivered by doctors of chiropractic , home exercise and advice ( HEA ) delivered by exercise therapists , and medication ( MED ) prescribed by a medical doctors for acute/subacute neck pain .
METHODS	Differences in satisfaction with specific aspects of care were analyzed using a linear mixed model .
METHODS	The relationship between specific aspects of care and ( 1 ) change in neck pain ( primary outcome of the randomized trial ) and ( 2 ) global satisfaction were assessed using Pearson 's correlation and multiple linear regression .
RESULTS	Individuals receiving SMT or HEA were more satisfied with the information and general care received than MED group participants .
RESULTS	Spinal manipulation therapy and HEA groups reported similar satisfaction with information provided during treatment ; however , the SMT group was more satisfied with general care .
RESULTS	Satisfaction with general care ( r = -0.75 to -0.77 ; R ( 2 ) = 0.55-0 .56 ) had a stronger relationship with global satisfaction compared with satisfaction with information provided ( r = -0.65 to 0.67 ; R ( 2 ) = 0.39-0 .46 ) .
RESULTS	The relationship between satisfaction with care and neck pain was weak ( r = 0.17-0 .38 ; R ( 2 ) = 0.08-0 .21 ) .
CONCLUSIONS	Individuals with acute/subacute neck pain were more satisfied with specific aspects of care received during spinal manipulation therapy or home exercise interventions compared to receiving medication .
CONCLUSIONS	The relationship between neck pain and satisfaction with care was weak .

###24736801
OBJECTIVE	The need for assistance from others is a hallmark concern in Alzheimer 's disease ( AD ) .
OBJECTIVE	The psychometric properties of the Dependence Scale ( DS ) for measuring treatment benefit were investigated in large randomized clinical trials of patients with mild to moderate AD .
METHODS	Reliability , validity , and responsiveness of the DS were examined .
METHODS	Path models appraised relationships and distinctiveness of key AD measures .
METHODS	The responder definition was empirically derived .
RESULTS	Generally acceptable reliability ( .65 ) , significant ( P < .001 ) known-groups tests , and moderate to strong correlations ( r .31 ) confirmed the DS psychometric properties .
RESULTS	Path models supported relationships and distinctiveness of key AD measures .
RESULTS	A DS change of 1 point for patients with limited home care and 2 points for patients with assisted living care best described stability of the level of dependence on caregivers .
CONCLUSIONS	The DS is a psychometrically robust measure in mild to moderate AD .
CONCLUSIONS	The empirically derived responder definition aids in the interpretation of DS change .

###24326120
BACKGROUND	This study compared the oral hygiene and caries risk of patients treated with labial and lingual orthodontic appliances throughout a prospective evaluation of the status of the oral environment before and after bracket placement .
METHODS	A total of 20 orthodontic patients aged 19 to 23 years were included in the study and were divided into two groups : 10 patients wore Roth labial appliance ( American Orthodontics , Sheboygan , WI , USA ) and 10 patients wore STb lingual appliance ( Ormco Corporation , Glendora , CA , USA ) .
METHODS	Plaque index ( PI ) , gingival bleeding index ( GBI ) , salivary flow rate , saliva buffer capacity , salivary pH , and Streptococcus mutans and Lactobacillus counts in saliva were determined at three time points : before orthodontic appliance placement ( T0 ) , 4 weeks after bonding ( T1 ) , and 8 weeks after bonding ( T2 ) .
METHODS	After appliance placement , all patients were periodically educated to the oral hygiene procedures .
METHODS	Wilcoxon rank and Mann-Whitney U tests were used to determine intragroup and intergroup differences as regards qualitative data .
METHODS	To compare quantitative data between the groups , chi-square and Fisher 's exact tests were undertaken , while intragroup differences were tested with McNemar test .
METHODS	The level of statistical significance was set at p < 0.05 .
RESULTS	Statistical analysis of the data obtained revealed a statistically significant difference between the data of T0 and T1 and the data of T0 and T2 of the PI scores and between T0 and T2 of the GBI scores in the group treated with the lingual appliance .
RESULTS	The GBI value increased significantly between T0 and T1 but decreased significantly between T1 and T2 ( p < 0.01 ) in the group treated with labial appliance .
RESULTS	S. mutans counts increased significantly between T0 and T2 in the saliva samples of patients treated with lingual appliance .
RESULTS	No statistically significant differences were found between S. mutans and Lactobacillus counts at the three terms of saliva collection in patients treated with labial appliance .
RESULTS	No statistically significant differences were found between the two groups at the three time points as regards the salivary flow rate and saliva buffer capacity .
CONCLUSIONS	Lingual and labial orthodontic appliances showed a different potential in modifying the investigated clinical parameters : patients wearing STb lingual orthodontic appliance had more plaque retention 4 and 8 weeks after bonding , while there were more gingival inflammation and more S. mutans counts 8 weeks after bonding .
CONCLUSIONS	No differences were found between the two groups as regards the Lactobacillus counts , the salivary flow rate , and saliva buffer capacity .

###25201555
OBJECTIVE	Application of an abdominal binder is often part of a standard postoperative regimen after ventral hernia repair to reduce pain and seroma formation .
OBJECTIVE	However , there is lack of evidence of the clinical effects .
OBJECTIVE	The aim of the present study was to investigate the pain - and seroma-reducing effect of an abdominal binder in patients undergoing laparoscopic umbilical or epigastric hernia repair .
METHODS	Based on power analysis , a minimum of 54 patients undergoing laparoscopic umbilical and epigastric hernia repair were to be included .
METHODS	Patients were randomized to abdominal binders vs. no abdominal binders during the first postoperative week .
METHODS	Standardized surgical technique , anaesthesia , and analgesic regimens were used and study observers were blinded towards the intervention .
METHODS	Postoperative pain ( visual analogue score ) on day 1 was the primary outcome .
METHODS	In addition , ultrasonographic evaluation of seroma formation and several subjective patient-related parameters were registered .
METHODS	Furthermore , patients in the abdominal binder group were asked to rate benefits or discomforts of wearing the binder .
RESULTS	Data from 56 patients ( abdominal binder , n = 28 ; no binder , n = 28 ) were available for analysis .
RESULTS	No significant intergroup differences in postoperative pain or any of the other surgical outcomes , including seroma formation , were found .
RESULTS	However , the abdominal binder group reported subjective beneficial effect of wearing the binder in 24 of the 28 patients ( 86 % ) .
RESULTS	No adverse effects of the abdominal binder were found .
CONCLUSIONS	There were no effects of an abdominal binder on pain , movement limitation , fatigue , seroma formation , general well-being , or quality of life .
CONCLUSIONS	However , most patients claimed a subjective beneficial effect of using their abdominal binder .

###25058329
OBJECTIVE	This study aimed to examine the association between changes in objectively measured overall physical activity ( PA ) and changes in fasting and postprandial plasma insulin , C-peptide , and glucose concentrations in type 2 diabetes-prone immigrant Pakistani men living in Norway and to examine whether this association is explained by changes in moderate and vigorous PA ( MVPA ) or changes in sedentary time .
METHODS	The current study is a secondary cohort analysis on data collected from the Physical Activity and Minority Health study , a randomized controlled trial aimed at increasing the PA level , and not sedentary time per se , in a group of sedentary immigrant Pakistani men ( n = 150 ) .
METHODS	For the present analyses , the two groups were merged and a cohort analysis was performed .
METHODS	Overall PA ( counts per minute ) and its subcomponents , sedentary time and MVPA , were measured with accelerometry .
METHODS	Outcome variables were measured after a 2-h standardized glucose tolerance test .
RESULTS	Change in overall PA was significantly associated with postprandial log-transformed plasma insulin ( = -0.002 ; 95 % confidence interval ( CI ) , -0.003 to 0.000 ; P = 0.008 ) , C-peptide ( = -2.7 ; 95 % CI , -4.9 to -0.5 ; P = 0.01 ) , and glucose concentration ( = -0.006 ; 95 % CI , -0.01 to -0.002 ; P = 0.002 ) .
RESULTS	Change in sedentary time was significantly and beneficially associated with changes in postprandial log-transformed plasma insulin ( = 0.002 ; 95 % CI , 0.001-0 .003 ; P = 0.001 ) , C-peptide ( = 3.7 ; 95 % CI , 1.5-6 .0 ; P = 0.001 ) , and glucose concentration ( = 0.006 ; 95 % CI , 0.002-0 .1 ; P = 0.002 ) , independent of changes in MVPA , waist circumference , and other confounders .
CONCLUSIONS	Increasing overall PA by reducing sedentary time seems as important as increasing time spent at MVPA in relation to postprandial plasma insulin and glucose levels in diabetes-prone immigrant men .

###24255546
BACKGROUND	Exercise treatment is recommended for all patients with hip osteoarthritis ( OA ) , but its effect on the long-term need for total hip replacement ( THR ) is unknown .
METHODS	We conducted a long-term follow-up of a randomised trial investigating the efficacy of exercise therapy and patient education versus patient education only on the 6-year cumulative survival of the native hip to THR in 109 patients with symptomatic and radiographic hip OA .
METHODS	Results regarding the primary outcome measure of the trial , self-reported pain at 16months follow-up , have been reported previously .
RESULTS	There were no group differences at baseline .
RESULTS	The response rate at follow-up was 94 % .
RESULTS	22 patients in the group receiving both exercise therapy and patient education and 31 patients in the group receiving patient education only underwent THR during the follow-up period , giving a 6-year cumulative survival of the native hip of 41 % and 25 % , respectively ( p = 0.034 ) .
RESULTS	The HR for survival of the native hip was 0.56 ( CI 0.32 to 0.96 ) for the exercise therapy group compared with the control group .
RESULTS	Median time to THR was 5.4 and 3.5 years , respectively .
RESULTS	The exercise therapy group had better self-reported hip function prior to THR or end of study , but no significant differences were found for pain and stiffness .
CONCLUSIONS	Our findings in this explanatory study suggest that exercise therapy in addition to patient education can reduce the need for THR by 44 % in patients with hip OA .
CONCLUSIONS	ClinicalTrials.gov number NCT00319423 ( original project protocol ) and NCT01338532 ( additional protocol for long-term follow-up ) .

###26063068
BACKGROUND	Previous trials of prenatal iron supplementation had limited measures of maternal or neonatal iron status .
OBJECTIVE	The purpose was to assess effects of prenatal iron-folate supplementation on maternal and neonatal iron status .
METHODS	Enrollment occurred June 2009 through December 2011 in Hebei , China .
METHODS	Women with uncomplicated singleton pregnancies at 20 wk gestation , aged 18 y , and with hemoglobin 100 g/L were randomly assigned 1:1 to receive daily iron ( 300 mg ferrous sulfate ) or placebo + 0.40 mg folate from enrollment to birth .
METHODS	Iron status was assessed in maternal venous blood ( at enrollment and at or near term ) and cord blood .
METHODS	Primary outcomes were as follows : 1 ) maternal iron deficiency ( ID ) defined in 2 ways as serum ferritin ( SF ) < 15 g/L and body iron ( BI ) < 0 mg/kg ; 2 ) maternal ID anemia [ ID + anemia ( IDA ) ; hemoglobin < 110 g/L ] ; and 3 ) neonatal ID ( cord blood ferritin < 75 g/L or zinc protoporphyrin/heme > 118 mol/mol ) .
RESULTS	A total of 2371 women were randomly assigned , with outcomes for 1632 women or neonates ( 809 placebo/folate , 823 iron/folate ; 1579 mother-newborn pairs , 37 mothers , 16 neonates ) .
RESULTS	Most infants ( 97 % ) were born at term .
RESULTS	At or near term , maternal hemoglobin was significantly higher ( +5.56 g/L ) for iron vs. placebo groups .
RESULTS	Anemia risk was reduced ( RR : 0.53 ; 95 % CI : 0.43 , 0.66 ) , as were risks of ID ( RR : 0.74 ; 95 % CI : 0.69 , 0.79 by SF ; RR : 0.65 ; 95 % CI : 0.59 , 0.71 by BI ) and IDA ( RR : 0.49 ; 95 % CI : 0.38 , 0.62 by SF ; RR : 0.51 ; 95 % CI : 0.40 , 0.65 by BI ) .
RESULTS	Most women still had ID ( 66.8 % by SF , 54.7 % by BI ) .
RESULTS	Adverse effects , all minor , were similar by group .
RESULTS	There were no differences in cord blood iron measures ; > 45 % of neonates in each group had ID .
RESULTS	However , dose-response analyses showed higher cord SF with more maternal iron capsules reported being consumed ( per 10 capsules = 2.60 , P < 0.05 ) .
CONCLUSIONS	Prenatal iron supplementation reduced anemia , ID , and IDA in pregnant women in rural China , but most women and > 45 % of neonates had ID , regardless of supplementation .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT02221752 .

###24453922
BACKGROUND	Noise as a common physical hazard may lead to noise-induced hearing loss , an irreversible but preventable disorder .
BACKGROUND	Annual audiometric evaluations help detect changes in hearing status before clinically significant hearing loss develops .
BACKGROUND	This study was designed to track hearing threshold changes during 2-year follow-up among tile and ceramic workers .
METHODS	This follow-up study was conducted on 555 workers ( totally 1110 ears ) .
METHODS	Subjects were divided into four groups according to the level of noise exposure .
METHODS	Hearing threshold in conventional audiometric frequencies was measured and standard threshold shift was calculated for each ear .
RESULTS	Hearing threshold was increased during 2 years of follow-up .
RESULTS	Increased hearing threshold was most frequently observed at 4000 , 6000 , and 3000 Hz .
RESULTS	Standard threshold shift was observed in 13 ( 2.34 % ) , 49 ( 8.83 % ) , 22 ( 3.96 % ) , and 63 ( 11.35 % ) subjects in the first and second years of follow-up in the right and left ears , respectively .
CONCLUSIONS	This study has documented a high incidence of noise-induced hearing loss in tile and ceramic workers that would put stress on the importance of using hearing protection devices .

###25604764
BACKGROUND	Uruguay is located at the southern border of Aedes aegypti distribution on the South American sub-continent .
BACKGROUND	The reported dengue cases in the country are all imported from surrounding countries .
BACKGROUND	One of the cities at higher risk of local dengue transmission is Salto , a border city with heavy traffic from dengue endemic areas .
METHODS	We completed an intervention study using a cluster randomized trial design in 20 randomly selected ` clusters ' in Salto .
METHODS	The clusters were located in neighborhoods of differing geography and economic , cultural and social aspects .
RESULTS	Entomological surveys were carried out to measure the impact of the intervention on vector densities .
RESULTS	Through participatory processes of all stakeholders , an appropriate ecosystem management intervention was defined .
RESULTS	Residents collected the abundant small water holding containers and the Ministry of Public Health and the Municipality of Salto were responsible for collecting and eliminating them .
RESULTS	Additional vector breeding places were large water tanks ; they were either altered so that they could not hold water any more or covered so that oviposition by mosquitoes could not take place .
CONCLUSIONS	The response from the community and national programme managers was encouraging .
CONCLUSIONS	The intervention evidenced opportunities for cost savings and reducing dengue vector densities ( although not to statistically significant levels ) .
CONCLUSIONS	The observed low vector density limits the potential reduction due to the intervention .
CONCLUSIONS	A larger sample size is needed to obtain a statistically significant difference .

###26412456
BACKGROUND	Nivolumab , a fully human IgG4 programmed death 1 ( PD-1 ) immune-checkpoint-inhibitor antibody , disrupts PD-1-mediated signaling and may restore antitumor immunity .
METHODS	In this randomized , open-label , international phase 3 study , we assigned patients with nonsquamous non-small-cell lung cancer ( NSCLC ) that had progressed during or after platinum-based doublet chemotherapy to receive nivolumab at a dose of 3 mg per kilogram of body weight every 2 weeks or docetaxel at a dose of 75 mg per square meter of body-surface area every 3 weeks .
METHODS	The primary end point was overall survival .
RESULTS	Overall survival was longer with nivolumab than with docetaxel .
RESULTS	The median overall survival was 12.2 months ( 95 % confidence interval [ CI ] , 9.7 to 15.0 ) among 292 patients in the nivolumab group and 9.4 months ( 95 % CI , 8.1 to 10.7 ) among 290 patients in the docetaxel group ( hazard ratio for death , 0.73 ; 96 % CI , 0.59 to 0.89 ; P = 0.002 ) .
RESULTS	At 1 year , the overall survival rate was 51 % ( 95 % CI , 45 to 56 ) with nivolumab versus 39 % ( 95 % CI , 33 to 45 ) with docetaxel .
RESULTS	With additional follow-up , the overall survival rate at 18 months was 39 % ( 95 % CI , 34 to 45 ) with nivolumab versus 23 % ( 95 % CI , 19 to 28 ) with docetaxel .
RESULTS	The response rate was 19 % with nivolumab versus 12 % with docetaxel ( P = 0.02 ) .
RESULTS	Although progression-free survival did not favor nivolumab over docetaxel ( median , 2.3 months and 4.2 months , respectively ) , the rate of progression-free survival at 1 year was higher with nivolumab than with docetaxel ( 19 % and 8 % , respectively ) .
RESULTS	Nivolumab was associated with even greater efficacy than docetaxel across all end points in subgroups defined according to prespecified levels of tumor-membrane expression ( 1 % , 5 % , and 10 % ) of the PD-1 ligand .
RESULTS	Treatment-related adverse events of grade 3 or 4 were reported in 10 % of the patients in the nivolumab group , as compared with 54 % of those in the docetaxel group .
CONCLUSIONS	Among patients with advanced nonsquamous NSCLC that had progressed during or after platinum-based chemotherapy , overall survival was longer with nivolumab than with docetaxel .
CONCLUSIONS	( Funded by Bristol-Myers Squibb ; CheckMate 057 ClinicalTrials.gov number , NCT01673867 . )

###25070172
BACKGROUND	Gross cystic disease fluid protein 15 ( GCDFP-15 ) , which is regulated by the androgen receptor ( AR ) , is a diagnostic marker for mammary differentiation in histopathology .
BACKGROUND	We determined the expression of GCDFP-15 in breast cancer subtypes , its potential prognostic and predictive value , as well as its relationship to AR expression .
METHODS	602 pre-therapeutic breast cancer core biopsies from the phase III randomized neoadjuvant GeparTrio trial ( NCT00544765 ) were investigated for GCDFP-15 expression by immunohistochemistry .
METHODS	Expression data were correlated with disease-free ( DFS ) and overall survival ( OS ) time as well as pathological complete response ( pCR ) to neoadjuvant chemotherapy .
RESULTS	239 tumors ( 39.7 % ) were GCDFP-15 positive .
RESULTS	GCDFP-15 expression was positively linked to hormone receptor ( HR ) and HER2 positive tumor type , while most triple negative carcinomas were negative ( p < 0.0001 ) .
RESULTS	GCDFP-15 was also strongly correlated to AR expression ( p 0.001 ) , and to the so-called molecular apocrine subtype ( HR - / AR + , p < 0.0001 ) .
RESULTS	Higher rates of GCDFP-15 positivity were seen in tumors of lower grade ( < 0.0001 ) and negative nodal status ( p = 0.008 ) .
RESULTS	GCDFP-15 positive tumors tended to have a more favourable prognosis than GCDFP-15 negative tumors ( DFS ( p = 0.052 ) and OS ( p = 0.044 ) ) , which was not independent from other factors in multivariate analysis .
RESULTS	GCDFP-15 expression was not linked to pCR .
RESULTS	Histological apocrine differentiation was frequent in molecular apocrine carcinomas ( 60.7 % ) , and was associated with GCDFP-15 within this group ( p = 0.039 ) .
CONCLUSIONS	GCDFP-15 expression is higher in tumors with favorable prognostic features .
CONCLUSIONS	GCDFP-15 expression is further a frequent feature of AR positive tumors and the molecular apocrine subtype .
CONCLUSIONS	It might have reduced sensitivity as a diagnostic marker for mammary differentiation in triple negative tumors as compared to HR or HER2 positive tumor types .

###25452012
BACKGROUND	Owing to mobility limitations , people with lumbar spinal stenosis ( LSS ) are at risk for diseases of inactivity , including obesity .
BACKGROUND	Therefore , weight management in LSS is critical .
BACKGROUND	Body mass index is the strongest predictor of function in LSS , suggesting that weight loss may promote physical activity and provide a unique treatment option .
BACKGROUND	We propose a lifestyle modification approach of physical activity and nutrition education , delivered through an e-health platform .
OBJECTIVE	The purpose of this study was to develop and pilot an e-health intervention aimed at increasing physical activity and decreasing fat mass in people with LSS .
METHODS	The study design was based on intervention development and pilot .
METHODS	Ten overweight or obese individuals with LSS were confirmed clinically and on imaging .
METHODS	Self-reported measures were food record , Short-Form 36 ( SF-36 ) , pain scales , Swiss Spinal Stenosis Symptom and Physical Function Scales , Oswestry Disability Index ( ODI ) , Pain Catastrophizing Questionnaire , Tampa Scale for Kinesiophobia , Center for Epidemiologic Studies ( Depression ) Scale , Behavioral Regular in Exercise Questionnaire , and Regulation for Eating Behavior Scale and physiologic measures were dual-energy X-ray absorptiometry ( DXA ) , blood draw , 7-day accelerometry , self-paced walking test , and balance test .
METHODS	The e-health platform was developed .
METHODS	during Week 1 , participants received a pedometer and a personalized consultation with a dietitian and an exercise physiologist .
METHODS	For 12 weeks , participants logged on to the e-health Web site to access personal step goals , nutrition education videos , and a discussion board .
METHODS	Follow-up occurred at Week 13 .
RESULTS	Nine participants had a mean age of 67.56.7 years ( 60 % women ) .
RESULTS	Significant improvements were observed for fat mass ( DXA ) , trunk fat mass , symptom severity ( Swiss Symptom Scale ) , energy intake , maximum continuous activity ( accelerometry ) , and mental health ( SF-36 ) ( p < .05 ) .
RESULTS	Nonsignificant improvements were observed for waist circumference , pain , ODI , and obesity biomarkers .
RESULTS	Seventy percent lost weight , 50 % increased walking capacity , and 60 % increased quality of life .
RESULTS	The mean increase in steps was 15 % .
CONCLUSIONS	The spinal stenosis pedometer and nutrition lifestyle intervention was shown to be feasible , attractive to participants , and effective in this small sample .
CONCLUSIONS	This intervention provides people with LSS the opportunity to participate in their own health management , potentially improving access to care .
CONCLUSIONS	Efficacy is currently being assessed in a randomized trial .

###24821894
OBJECTIVE	Guideline implementation in primary care has proven difficult .
OBJECTIVE	Although external assistance through performance feedback , academic detailing , practice facilitation ( PF ) , and learning collaboratives seems to help , the best combination of interventions has not been determined .
METHODS	In a cluster randomized trial , we compared the independent and combined effectiveness of PF and local learning collaboratives ( LLCs ) , combined with performance feedback and academic detailing , with performance feedback and academic detailing alone on implementation of the National Heart , Lung and Blood Institute 's Asthma Guidelines .
METHODS	The study was conducted in 3 primary care practice-based research networks .
METHODS	Medical records of patients with asthma seen during pre - and postintervention periods were abstracted to determine adherence to 6 guideline recommendations .
METHODS	McNemar 's test and multivariate modeling were used to evaluate the impact of the interventions .
RESULTS	Across 43 practices , 1,016 patients met inclusion criteria .
RESULTS	Overall , adherence to all 6 recommendations increased ( P .002 ) .
RESULTS	Examination of improvement by study arm in unadjusted analyses showed that practices in the control arm significantly improved adherence to 2 of 6 recommendations , whereas practices in the PF arm improved in 3 , practices in the LLCs improved in 4 , and practices in the PF + LLC arm improved in 5 of 6 recommendations .
RESULTS	In multivariate modeling , PF practices significantly improved assessment of asthma severity ( odds ratio [ OR ] = 2.5 , 95 % CI , 1.7-3 .8 ) and assessment of asthma level of control ( OR = 2.3 , 95 % CI , 1.5-3 .5 ) compared with control practices .
RESULTS	Practices assigned to LLCs did not improve significantly more than control practices for any recommendation .
CONCLUSIONS	Addition of PF to performance feedback and academic detailing was helpful to practices attempting to improve adherence to asthma guidelines .

###24321802
BACKGROUND	The Single combination budesonide-formoterol inhaler Maintenance And Reliever Therapy ( SMART ) regimen reduces severe asthma exacerbations in patients , but whether the high doses of corticosteroid and agonist increase the risk of adverse effects with both short-term and cumulative exposure is not certain .
BACKGROUND	Our aim was to investigate whether the SMART regimen would reduce the risk of overuse of agonist , reduce the likelihood of patients to seek medical review when such episodes occurred , and if any reduction in severe asthma exacerbations would be at the cost of a higher burden of systemic corticosteroid .
METHODS	In this 24-week trial undertaken at four primary health-care practices and one hospital in New Zealand , patients ( aged 16-65 years ) with a recent asthma exacerbation were randomly assigned in a 1:1 ratio to the SMART or standard fixed-dose regimen .
METHODS	Treatment in the SMART group consisted of two actuations of budesonide-formoterol ( 200 g and 6 g , respectively , per actuation ) twice daily , delivered through a combination metered dose inhaler ( MDI ) , with one extra actuation as needed for relief of symptoms ; treatment in the standard group consisted of two actuations of budesonide-formoterol ( 200 g and 6 g , respectively , per actuation ) twice daily through a combination MDI with one to two actuations of salbutamol ( 100 g per actuation ) by MDI as needed for relief of symptoms .
METHODS	MDIs were monitored electronically to measure actual use of medication .
METHODS	The allocation sequence for randomisation was computer generated , with a block size of eight per site .
METHODS	Participants , investigators , and the statistician were not masked to group assignment .
METHODS	The primary outcome was the proportion of participants with at least one high-use episode of agonist ( more than eight actuations per day of budesonide-formoterol in addition to the four maintenance doses in the SMART group or more than 16 actuations per day of salbutamol in the standard group ) .
METHODS	Analysis was by intention to treat .
METHODS	This trial is registered with the Australian New Zealand Clinical Trials Registry , number ACTRN12610000515099 .
RESULTS	303 patients were randomly assigned to the SMART ( n = 151 ) or standard group ( n = 152 ) .
RESULTS	No significant difference was noted between the SMART and standard groups in the proportion of participants with at least one high-use episode of agonist ( 84 [ 56 % ] vs 68 [ 45 % ] , respectively , relative risk 124 [ 95 % CI 099-156 ] ; p = 0058 ) .
RESULTS	There were fewer days of high use in the SMART group ( mean 51 days [ SD 143 ] vs 89 days [ 209 ] , relative rate 058 [ 039-088 ] ; p = 001 ) .
RESULTS	Of the patients who had at least one high-use episode , those in the SMART group had fewer days of high use without medical review ( 85 days [ 178 ] vs 183 days [ 248 ] , 049 [ 031-075 ] ; p = 0001 ) .
RESULTS	The SMART regimen resulted in higher inhaled corticosteroid exposure ( 9435 g budesonide per day [ 15025 ] vs 6843 g budesonide per day [ 3905 ] , respectively ; ratio of means 122 [ 106-141 ] ; p = 0006 ) , but reduced oral corticosteroid exposure ( 775 mg prednisone [ 2405 ] vs 1266 mg prednisone [ 3821 ] , respectively ; p = 0011 ) , with no significant difference in composite systemic corticosteroid exposure ( 7937 mg prednisone equivalent per year [ 8931 ] vs 7721 mg prednisone equivalent per year [ 10627 ] , respectively ; 103 [ 086-122 ] ; p = 076 ) .
RESULTS	Participants in the SMART group had fewer severe asthma exacerbations ( 35 [ weighted mean rate per year 053 ] vs 66 [ 097 ] ; relative rate 054 [ 036-082 ] ; p = 0004 ) .
CONCLUSIONS	The SMART regimen has a favourable risk-to-benefit profile and can be recommended for use in adults at risk of severe asthma exacerbations .
BACKGROUND	Health Research Council of New Zealand .

###24432676
OBJECTIVE	To evaluate anti-depressive effects of acupuncture on selective serotonin reuptake inhibitors ( SSRIs ) .
METHODS	Totally 60 patients with depression were randomly assigned to the control group ( 30 cases ) and the treatment group ( 30 cases ) .
METHODS	All patients took one kind of SSRIs .
METHODS	Those in the treatment group were additionally treated by acupuncture .
METHODS	All were treated for 6 weeks .
METHODS	Patients ' efficacies were evaluated with Hamilton Depression Scale ( HAMD ) , Self-rating Depression Scale ( SDS ) , and Eisenberg antidepressant side effects scale ( Asberg ) .
RESULTS	Compared with the control group after 6 weeks of treatment , the cured-markedly effective rate was improved by 33.4 % in the treatment group ( P < 0.05 ) .
RESULTS	The HAMD was lower in the treatment group .
RESULTS	The tendency of interaction of sleep disorder factor and anxiety/somatization factor was different between at the end of 1-week treatment and at the end of 6-week treatment in the treatment group ( P < 0.05 ) .
RESULTS	The SDS score decreased at the end of 6-week treatment in the treatment group .
RESULTS	The reduction rate was elevated by 19.23 % ( P < 0.05 ) .
RESULTS	By the end of 6-week treatment , the average score of Asberg decreased by 3.77 score in average in the treatment group , while it decreased by 0.07 score in average in the control group ( P < 0.05 ) .
CONCLUSIONS	Acupuncture could effectively improve anti-depressive effects of SSRIs and reduce their adverse reactions .

###25732417
OBJECTIVE	The aim of this study was to assess the long-term prognosis , efficacy , and safety of combination therapy using ursodeoxycholic acid ( UDCA ) and bezafibrate ( BF ) for primary biliary cirrhosis ( PBC ) patients exhibiting dyslipidemia .
METHODS	We performed a prospective , randomized , controlled , multicenter study to compare the long-term clinical results between combination therapy and UDCA monotherapy for patients refractory to UDCA monotherapy .
METHODS	Twenty-seven consecutive PBC patients were enrolled .
RESULTS	The median treatment period in the UDCA and UDCA+BF groups was 107 and 110 months , respectively .
RESULTS	The serum alkaline phosphatase ( ALP ) levels and the Mayo risk score in the combination therapy group ( mean 290IU/l and 0.91 , respectively ) were significantly lower than those in the UDCA monotherapy group ( mean 461IU/l and 1.42 , respectively ) at 8 years after the beginning of the study ( P < 0.05 ) .
RESULTS	The serum creatinine levels in the combination therapy group ( mean 0.94 mg/dl ) were significantly higher than those in the UDCA monotherapy group ( mean 0.56 mg/dl ) at 8 years after the beginning of the study ( P < 0.05 ) .
RESULTS	However , the survival rate was not significantly different between the groups .
RESULTS	We observed dose reduction or discontinuation of the administration of BF , but not UDCA , due to renal dysfunction or muscle pain .
CONCLUSIONS	Long-term combination therapy significantly improved the serum ALP levels and the Mayo risk score .
CONCLUSIONS	However , the survival rate was not significantly different between the groups .
CONCLUSIONS	In addition , long-term combination therapy significantly increased the serum creatinine levels .
CONCLUSIONS	We should pay close attention to adverse events during this long-term combination therapy .

###25350086
OBJECTIVE	To evaluate the effects of a dexmedetomidine constant rate infusion ( CRI ) and atropine on changes in global perfusion variables induced by hemorrhage and volume replacement ( VR ) in isoflurane-anesthetized dogs .
METHODS	8 adult dogs .
METHODS	Each dog was anesthetized twice , with a 2-week interval between anesthetic sessions .
METHODS	Anesthesia was maintained with 1.3 times the minimum alveolar concentration of isoflurane with and without dexmedetomidine ( 1.6 g/kg , IV bolus , followed by 2 g/kg/h , CRI ) .
METHODS	Dogs were mechanically ventilated and received an atracurium neuromuscular blockade during both sessions .
METHODS	During anesthesia with isoflurane and dexmedetomidine , atropine was administered 30 minutes before baseline measurements were obtained .
METHODS	After baseline data were recorded , 30 % of the total blood volume was progressively withdrawn and VR was achieved with an equal proportion of autologous blood .
RESULTS	Following hemorrhage , cardiac index , oxygen delivery index , and mixed-venous oxygen saturation were significantly decreased and the oxygen extraction ratio was significantly increased from baseline .
RESULTS	The anaerobic threshold was not achieved during either anesthetic session .
RESULTS	When dogs were anesthetized with isoflurane and dexmedetomidine , they had a significantly lower heart rate , cardiac index , and mixed-venous oxygen saturation during VR than they did when anesthetized with isoflurane alone .
RESULTS	Plasma lactate concentration , mixed venous-to-arterial carbon dioxide difference , base excess , and anion gap were unaltered by hemorrhage and VR and did not differ between anesthetic sessions .
CONCLUSIONS	Results indicated that the use of a dexmedetomidine CRI combined with atropine in isoflurane-anesthetized dogs that underwent volume-controlled hemorrhage followed by VR did not compromise global perfusion sufficiently to result in anaerobic metabolism .

###25602496
OBJECTIVE	Daily bathing of critically ill patients with the broad-spectrum , topical antimicrobial agent chlorhexidine is widely performed and may reduce health care-associated infections .
OBJECTIVE	To determine if daily bathing of critically ill patients with chlorhexidine decreases the incidence of health care-associated infections .
METHODS	A pragmatic cluster randomized , crossover study of 9340 patients admitted to 5 adult intensive care units of a tertiary medical center in Nashville , Tennessee , from July 2012 through July 2013 .
METHODS	Units performed once-daily bathing of all patients with disposable cloths impregnated with 2 % chlorhexidine or nonantimicrobial cloths as a control .
METHODS	Bathing treatments were performed for a 10-week period followed by a 2-week washout period during which patients were bathed with nonantimicrobial disposable cloths , before crossover to the alternate bathing treatment for 10 weeks .
METHODS	Each unit crossed over between bathing assignments 3 times during the study .
METHODS	The primary prespecified outcome was a composite of central line-associated bloodstream infections ( CLABSIs ) , catheter-associated urinary tract infections ( CAUTIs ) , ventilator-associated pneumonia ( VAP ) , and Clostridium difficile infections .
METHODS	Secondary outcomes included rates of clinical cultures that tested positive for multidrug-resistant organisms , blood culture contamination , health care-associated bloodstream infections , and rates of the primary outcome by ICU .
RESULTS	During the chlorhexidine bathing period , 55 infections occurred : 4 CLABSI , 21 CAUTI , 17 VAP , and 13 C difficile .
RESULTS	During the control bathing period , 60 infections occurred : 4 CLABSI , 32 CAUTI , 8 VAP , and 16 C difficile .
RESULTS	The primary outcome rate was 2.86 per 1000 patient-days during the chlorhexidine and 2.90 per 1000 patient-days during the control bathing periods ( rate difference , -0.04 ; 95 % CI , -1.10 to 1.01 ; P = .95 ) .
RESULTS	After adjusting for baseline variables , no difference between groups in the rate of the primary outcome was detected .
RESULTS	Chlorhexidine bathing did not change rates of infection-related secondary outcomes including hospital-acquired bloodstream infections , blood culture contamination , or clinical cultures yielding multidrug-resistant organisms .
RESULTS	In a prespecified subgroup analysis , no difference in the primary outcome was detected in any individual intensive care unit .
CONCLUSIONS	In this pragmatic trial , daily bathing with chlorhexidine did not reduce the incidence of health care-associated infections including CLABSIs , CAUTIs , VAP , or C difficile .
CONCLUSIONS	These findings do not support daily bathing of critically ill patients with chlorhexidine .
BACKGROUND	clinicaltrials.gov Identifier : NCT02033187 .

###25262375
OBJECTIVE	Get It & Forget It , an educational video about intrauterine devices ( IUDs ) , was developed and evaluated .
METHODS	A feasibility study and a pre/post evaluation nested within a randomized trial were conducted to test change in knowledge about IUDs and intention to get an IUD after viewing a theory-driven dramatic video .
METHODS	Participants ( n = 315 ) completed surveys before and after watching the video .
RESULTS	Knowledge about IUD effectiveness increased significantly ( 33 % to 64 % , p < .001 ) , as did intention to use an IUD ( 18 % to 36 % , p < .001 ) postvideo .
CONCLUSIONS	An online theory-driven video intervention can reach young women seeking information about long-acting contraception .

###25986447
BACKGROUND	Oxidative stress may contribute to heart failure ( HF ) progression .
BACKGROUND	Inhibiting xanthine oxidase in hyperuricemic HF patients may improve outcomes .
RESULTS	We randomly assigned 253 patients with symptomatic HF , left ventricular ejection fraction 40 % , and serum uric acid levels 9.5 mg/dL to receive allopurinol ( target dose , 600 mg daily ) or placebo in a double-blind , multicenter trial .
RESULTS	The primary composite end point at 24 weeks was based on survival , worsening HF , and patient global assessment .
RESULTS	Secondary end points included change in quality of life , submaximal exercise capacity , and left ventricular ejection fraction .
RESULTS	Uric acid levels were significantly reduced with allopurinol in comparison with placebo ( treatment difference , -4.2 [ -4.9 , -3.5 ] mg/dL and -3.5 [ -4.2 , -2.7 ] mg/dL at 12 and 24 weeks , respectively , both P < 0.0001 ) .
RESULTS	At 24 weeks , there was no significant difference in clinical status between the allopurinol - and placebo-treated patients ( worsened 45 % versus 46 % , unchanged 42 % versus 34 % , improved 13 % versus 19 % , respectively ; P = 0.68 ) .
RESULTS	At 12 and 24 weeks , there was no significant difference in change in Kansas City Cardiomyopathy Questionnaire scores or 6-minute walk distances between the 2 groups .
RESULTS	At 24 weeks , left ventricular ejection fraction did not change in either group or between groups .
RESULTS	Rash occurred more frequently with allopurinol ( 10 % versus 2 % , P = 0.01 ) , but there was no difference in serious adverse event rates between the groups ( 20 % versus 15 % , P = 0.36 ) .
CONCLUSIONS	In high-risk HF patients with reduced ejection fraction and elevated uric acid levels , xanthine oxidase inhibition with allopurinol failed to improve clinical status , exercise capacity , quality of life , or left ventricular ejection fraction at 24 weeks .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00987415 .

###25443069
BACKGROUND	Data on gastrointestinal ( GI ) side effects of bariatric surgery are limited because of incomplete reporting , cross-sectional samples , and nonstandardized assessments .
OBJECTIVE	To report on GI side effects over the first 6 months after Roux-en-Y gastric bypass ( RYGB ) and laparoscopic adjustable gastric banding ( LAGB ) .
METHODS	Academic medical center , United States .
METHODS	One hundred forty-four patients completed a standardized clinical interview 6 months after operation , including questions on the occurrence and frequency of episodes of dumping syndrome , vomiting , and plugging for each of the past 6 months ; monthly rates were stable , so results were averaged over the entire period .
METHODS	Although data were collected as part of a randomized controlled trial , randomization group and the interaction of group by surgical procedure were not related to GI side effects .
METHODS	Thus , results are reported by procedure only ( RYGB , n = 87 ; LAGB , n = 56 ) .
RESULTS	RYGB patients had a higher preoperative body mass index ( BMI ) than LAGB patients ( 46.86.8 versus 43.54.8 kg/m ( 2 ) , respectively ; P = .001 ) , were more likely to report dumping ( 45.7 % versus 4.7 % , P < .0001 ) , and were less likely to report plugging ( 45.7 % versus 79.1 % , P = .0005 ) .
RESULTS	Vomiting did not differ significantly by procedure ( 68.6 % versus 65.1 % , P = .7 ) .
RESULTS	Most patients experienced each GI side effect less than once per week .
CONCLUSIONS	Although self-reported GI side effects were common over the first 6 months after operation , the frequency of episodes was relatively low .
CONCLUSIONS	Longer-term follow-up is needed to determine whether symptoms worsen or improve over time .

###25927187
BACKGROUND	Many people with intellectual disability present with challenging behaviour which often has serious consequences such as the prescription of long term medication , in-patient admissions and disruption of normal daily activities .
BACKGROUND	Small scale studies of Positive Behaviour Support ( PBS ) delivered by paid carers suggest that it reduces challenging behaviour and costs of care and improves quality of life .
BACKGROUND	This study aims to investigate whether professionals training in the delivery of PBS as part of routine practice is clinically and cost effective compared to treatment as usual in community intellectual disability services .
METHODS	The study is a multi-centre cluster randomised controlled trial involving community intellectual disability services in England and service users with mild to severe intellectual disability and challenging behaviour .
METHODS	The teams will be randomly allocated into one of two conditions , either training and support to deliver PBS or treatment as usual .
METHODS	We will carry out assessments of challenging behaviour , use of services , quality of life , mental health , and family and paid carer burden at six and 12 months .
METHODS	We will monitor treatment fidelity and we will interview a sample of paid and family carers , service users , staff and managers about what they think of the treatment and how best we can deliver it in routine care .
METHODS	The main outcome is reduction in challenging behaviour at one year after randomisation .
METHODS	We will also carry out a health economic evaluation to examine the costs and consequences of staff training in PBS .
CONCLUSIONS	The study findings will have significant implications for the delivery of PBS in community based services with the potential for reducing inpatient admissions and out-of-area placements for adults with intellectual disability and challenging behaviour .
BACKGROUND	This trial is registered with Clinical Trials.gov ( Ref NCT01680276 ) .
BACKGROUND	Clinical Trials Unit : PRIMENT https://www.ucl.ac.uk/priment/ .

###25422026
OBJECTIVE	To investigate the effect of physical training combined with growth hormone ( GH ) on muscle thickness and its relationship with muscle strength and motor development in infants with Prader-Willi syndrome ( PWS ) .
METHODS	In a randomized controlled trial , 22 infants with PWS ( 12.9 7.1 months ) were followed over 2 years to compare a treatment group ( n = 10 ) with a waiting-list control group ( n = 12 ) .
METHODS	Muscle thickness of 4 muscle groups was measured by using ultrasound .
METHODS	Muscle strength was evaluated by using the Infant Muscle Strength meter .
METHODS	Motor performance was measured with the Gross Motor Function Measurement .
METHODS	Analyses of variance were used to evaluate between-group effects of GH on muscle thickness at 6 months and to compare pre - and posttreatment ( after 12 months of GH ) values .
METHODS	Multilevel analyses were used to evaluate effects of GH on muscle thickness over time , and multilevel bivariate analyses were used to test relationships between muscle thickness , muscle strength , and motor performance .
RESULTS	A significant positive effect of GH on muscle thickness ( P < .05 ) was found .
RESULTS	Positive relationships were found between muscle thickness and muscle strength ( r = 0.61 , P < .001 ) , muscle thickness and motor performance ( r = 0.81 , P < .001 ) , and muscle strength and motor performance ( r = 0.76 , P < .001 ) .
CONCLUSIONS	GH increased muscle thickness , which was related to muscle strength and motor development in infants with PWS .
CONCLUSIONS	Catch-up growth was faster in muscles that are most frequently used in early development .
CONCLUSIONS	Because this effect was independent of GH , it suggests a training effect .

###25526757
BACKGROUND	Vaginal infections are common , frequently recur , and may increase women 's risk for sexually transmitted infections ( STIs ) .
BACKGROUND	We tested the efficacy of a novel regimen to prevent recurrent vaginal infections .
METHODS	Human immunodeficiency virus ( HIV ) - negative women 18-45 years old with 1 or more vaginal infections , including bacterial vaginosis ( BV ) , vulvovaginal candidiasis ( VVC ) , or Trichomonas vaginalis ( TV ) , were randomly assigned to receive vaginal suppositories containing metronidazole 750 mg plus miconazole 200 mg or matching placebo for 5 consecutive nights each month for 12 months .
METHODS	Primary endpoints , evaluated every 2 months , were BV ( Gram stain ) and VVC ( positive wet mount and culture ) .
RESULTS	Participants ( N = 234 ) were randomly assigned to the intervention ( N = 118 ) or placebo ( N = 116 ) arm .
RESULTS	Two hundred seventeen ( 93 % ) women completed an end-of-study evaluation .
RESULTS	The intervention reduced the proportion of visits with BV compared to placebo ( 21.2 % vs 32.5 % ; relative risk [ RR ] 0.65 , 95 % confidence interval [ CI ] .48 -.87 ) .
RESULTS	In contrast , the proportion of visits with VVC was similar in the intervention ( 10.4 % ) versus placebo ( 11.3 % ) arms ( RR 0.92 , 95 % CI .62 -1.37 ) .
CONCLUSIONS	Monthly treatment with intravaginal metronidazole plus miconazole reduced the proportion of visits with BV during 12 months of follow-up .
CONCLUSIONS	Further study will be important to determine whether this intervention can reduce women 's risk of STIs .

###24296163
OBJECTIVE	The aim of this clinical study was to evaluate the retention rate and caries-prevention effect of a flowable composite compared to a conventional resin-based sealant in a young population over a 24-month period .
METHODS	Thirty-four patients , ranging in age from 16 to 22 years , diagnosed with at least 2 non-cavitated pit-and-fissure caries in the first and second molars were selected for this randomized split-mouth design trial .
METHODS	A total of 220 sealants , were placed in 117 upper molars and 103 lower molars .
METHODS	The teeth were sealed with a flowable resin composite ( Tetric Evo Flow ) or a sealant material ( Helioseal F ) .
METHODS	Each restoration was independently evaluated in terms of retention and the presence of caries at baseline and at 1 , 6 , 12 , and 24 months .
METHODS	Data were analyzed using non-parametric Mann-Whitney U and Friedman 1-way ANOVA tests at p < 0.05 .
RESULTS	Tetric Evo Flow showed complete retention with 100 % , 95.5 % , 93.8 % , and 88.5 % at 1 , 6 , 12 , and 24-month evaluations , respectively , while Helioseal F retention rates were 98.1 % , 95.5 % , 94.8 % , and 85.4 % , respectively , for the same evaluation periods .
RESULTS	At the 24-month recall , 4 ( 4.2 % ) total losses were observed in subjects treated with Tetric Evo Flow and 2 total losses ( 2.1 % ) for Helioseal F , respectively .
RESULTS	No significant differences were observed between the materials in retention rates or caries incidence for each evaluation period ( p > 0.05 ) .
CONCLUSIONS	Placement of flowable composite as fissure sealants in the younger population seems to be as effective as conventional fluoride containing fissure sealants for the prevention of fissure caries .
CONCLUSIONS	The use of a flowable composite as a fissure sealant material , in conjunction with a total-etch , single bottle adhesive , yielded better retention than did the conventional fluoride containing resin-based fissure sealant over a 24-month period in young patients .

###25702095
BACKGROUND	Total knee arthroplasty ( TKA ) is associated with significant perioperative blood loss and need for transfusion .
BACKGROUND	This study aimed to evaluate the effectiveness and safety of tranexamic acid ( TXA ) to reduce perioperative blood loss in patients receiving TKA .
METHODS	A total of 92 patients who accepted unilateral TKA from May 2012 to May 2013 randomly received either 15 mg/kg TXA in 100 mL normal saline solution ( TXA group , n = 46 ) or the same amount of normal saline solution ( placebo group , n = 46 ) at 15 min before the tourniquet was loosened .
METHODS	The following data were recorded : intraoperative blood loss ; post-operative drainage at 12 h ; total drainage amount ; hidden blood loss ; total blood loss ; transfusion volumes ; number of transfusions ; post-operative hemoglobin at 1 , 3 , and 5 days ; D-dimer ; number of lower limb ecchymoses ; and deep vein thrombosis ( DVT ) .
RESULTS	A total of 81 patients were available for analysis ( TXA group , n = 41 ; placebo group , n = 40 ) .
RESULTS	Post-operative12-h drainage , post-operative 24-h D-dimer values , total drainage volume , hidden blood loss , total blood loss , and the rate of postoperative ecchymosis were lower in the TXA group than in the placebo group ( p < 0.05 ) .
RESULTS	The post-operative 3-day Hgb was higher in the TXA group than in the placebo group ( p = 0.000 ) .
RESULTS	The rate of transfusion and DVT was similar in both groups ( n.s. ) .
CONCLUSIONS	Perioperative blood loss could be reduced after TKA by intravenously injecting 15 mg/kg TXA at 15 min before the tourniquet was loosened .
CONCLUSIONS	The application of TXA is not associated with increased risk of DVT .

###24684852
OBJECTIVE	A Knowledge Broker is one approach for facilitating the integration of evidence-informed decision making in public health practice .
OBJECTIVE	In this paper , the findings from two studies investigating a Knowledge Broker intervention as a means of enhancing capacity for evidence-informed decision making are presented .
OBJECTIVE	Contextual factors that facilitate this strategy are also identified .
METHODS	This paper describes work done through a single mixed-methods study ( randomized controlled trial with a qualitative component ) and a case study .
METHODS	The Health Evidence team conducted two studies examining Knowledge Broker impact in Canadian public health departments .
METHODS	The effectiveness of knowledge translation strategies of varying intensities for promoting the use of research evidence in decisions related to child obesity prevention were explored via a randomized controlled trial with a fundamental descriptive component ( 2003-2007 ) .
METHODS	In a case study ( 2010-2013 ) , the authors partnered with three health departments to develop and implement tailored strategies targeted at the organization .
METHODS	Knowledge Brokers worked with designated staff in these studies via one-on-one consultations , small group meetings , and/or workshops and presentations .
METHODS	The Knowledge Broker role was assessed by analysing data from close-ended surveys , interviews , organizational documents , and reflective journals .
RESULTS	In this paper , the authors focus on findings from the qualitative analysis of implementing the Knowledge Broker role in both studies and explore several contextual factors that impacted study outcomes .
RESULTS	Knowledge Brokers were shown to enhance individual capacity by improving knowledge and skill in searching for , critically appraising , and applying research evidence to practice-based issues .
RESULTS	Organizational capacity was also enhanced with strong management support and policies .
RESULTS	Effective Knowledge Broker attributes included both expertise in research methodology and public health , as well as intangible traits such as approachability and patience .
RESULTS	Finally , optimal positioning and ways of working were identified , including the importance of in-person meetings and neutrality of the Knowledge Broker .
CONCLUSIONS	Knowledge brokering is a potentially promising knowledge translation strategy for public health , though additional feasibility and cost-effectiveness data are still needed .
CONCLUSIONS	The research presented here further highlights the importance of context and adopting a tailored approach to implement a Knowledge Broker strategy .

###25528622
BACKGROUND	Open tibial fractures are usually caused by high-energy trauma .
BACKGROUND	There is no consensus about the best treatment for these fractures .
BACKGROUND	Biomechanical studies show that fixing on two planes approaches the rigidity of the bone , whereas the use of interlocking intramedullary nailing is widely used and reported to produce better therapeutic results in fracture healing .
OBJECTIVE	To compare bone tissue repair in patients with open diaphyseal tibial fracture treated with biplanar external fixation or reamed locked intramedullary nailing .
METHODS	Prospective randomised study with 68 patients undergoing two types of surgical treatment : biplanar external fixation or reamed locked intramedullary nailing .
METHODS	Consolidation , complications ( infection , malunion and non-union ) and quality of life using the SF-36 Health Survey were assessed 12 months after surgery .
RESULTS	Consolidation occurred in 84.6 % of patients who underwent reamed intramedullary nailing , and in 90.3 % of patients who were treated with biplanar external fixation .
RESULTS	In the intramedullary nailing group , there were two cases of non-union , three cases of malunion and two cases of infection .
RESULTS	In the patients treated with biplanar fixation , there were three cases of non-union , five cases of malunion and no cases of infection .
RESULTS	There were no statistically significant differences between the treatment groups for these results .
RESULTS	Patient quality of life was statistically equal for both methods .
CONCLUSIONS	Treatment with biplanar external fixation was associated with statistically similar results compared with intramedullary locking .

###24726867
OBJECTIVE	There are significant burdens associated with providing care for loved ones with cancer .
OBJECTIVE	However , caregiver quality of life ( QOL ) is often overlooked .
OBJECTIVE	With the increasing number of older adults with cancer , it is important to determine whether a patient 's age and QOL have any association with the caregiver 's QOL .
OBJECTIVE	The objective of our study was to describe caregiver QOL and explore whether patient age and other psychosocial factors impact caregiver QOL .
METHODS	Baseline information from patients with advanced cancer undergoing radiation and their caregivers , who were enrolled in a randomized , controlled clinical trial to test the effectiveness of a structured , multidisciplinary QOL intervention , was analyzed for this study .
METHODS	Caregivers completed the Caregiver Quality of Life Index-Cancer ( CQOLC ) Scale .
METHODS	Both patients and caregivers completed the Linear Analogue Self-Assessment ( LASA ) to measure QOL , and Profile of Mood States ( POMS ) to measure mood states .
RESULTS	Overall , 131 patient-caregiver pairs participated in the study .
RESULTS	At baseline , caregivers of older adults ( 65years ) had higher mental ( P = 0.01 ) , emotional ( P = 0.003 ) , spiritual ( P < 0.01 ) , and social support ( P = 0.03 ) LASA QOL scores .
RESULTS	Caregivers of older adults also had higher baseline QOL ( CQOLC , P = 0.003 ) and mood ( POMS , P = 0.04 ) than caregivers of younger adults .
RESULTS	Caregivers of patients with higher LASA QOL scores had higher overall ( P = 0.02 ) , mental ( P = 0.006 ) , physical ( P = 0.02 ) , emotional ( P = 0.002 ) , and spiritual LASA QOL scores ( P = 0.047 ) .
CONCLUSIONS	Caregivers of older adults with advanced cancer demonstrated better QOL and fewer mood disturbances compared to caregivers of younger patients .
CONCLUSIONS	When patients have good QOL , caregivers also had good QOL .

###25770984
OBJECTIVE	Cranial nerve injury ( CNI ) is the most common neurologic complication of carotid endarterectomy ( CEA ) and can cause significant chronic disability .
OBJECTIVE	Data from prior randomized trials are limited and provide no health-related quality of life ( HRQOL ) outcomes specific to CNI .
OBJECTIVE	Incidence of CNIs and their outcomes for patients in the Carotid Revascularization Endarterectomy vs Stenting Trial ( CREST ) were examined to identify factors predictive of CNI and their impact on HRQOL .
METHODS	Incidence of CNIs , baseline and procedural characteristics , outcomes , and HRQOL scores were evaluated in the 1151 patients randomized to CEA and undergoing surgery 30 days .
METHODS	Patients with CNI were identified and classified using case report forms , adverse event data , and clinical notes .
METHODS	Baseline and procedural characteristics were compared using descriptive statistics .
METHODS	Clinical outcomes at 1 and 12 months were analyzed .
METHODS	All data were adjudicated by two neurologists and a vascular surgeon .
METHODS	HRQOL was evaluated using the Medical Outcomes Short-Form 36 ( SF-36 ) Health Survey to assess general health and Likert scales for disease-specific outcomes at 2 weeks , 4 weeks , and 12 months after CEA .
METHODS	The effect of CNI on SF-36 subscales was evaluated using random effects growth curve models , and Likert scale data were compared by ordinal logistic regression .
RESULTS	CNI was identified in 53 patients ( 4.6 % ) .
RESULTS	Cranial nerves injured were VII ( 30.2 % ) , XII ( 24.5 % ) , and IX/X ( 41.5 % ) , and 3.8 % had Horner syndrome .
RESULTS	CNI occurred in 52 of 1040 patients ( 5.0 % ) receiving general anesthesia and in one of 111 patients ( 0.9 % ) operated on under local anesthesia ( P = .05 ) .
RESULTS	No other predictive baseline or procedural factors were identified .
RESULTS	Deficits resolved in 18 patients ( 34 % ) at 1 month and in 42 of 52 patients ( 80.8 % ) by 1 year .
RESULTS	One patient died before the 1-year follow-up visit .
RESULTS	The HRQOL evaluation showed no statistical difference between groups with and without CNI at any interval .
RESULTS	By Likert scale analysis , the group with CNI showed a significant difference in the difficulty eating/swallowing parameter at 2 and 4 weeks ( P < .001 ) but not at 1 year .
CONCLUSIONS	In CREST , CNI occurred in 4.6 % of patients undergoing CEA , with 34 % resolution at 30 days and 80.8 % at 1 year .
CONCLUSIONS	The incidence of CNI was significantly higher in patients undergoing general anesthesia .
CONCLUSIONS	CNI had a small and transient effect on HRQOL , negatively affecting only difficulty eating/swallowing at 2 and 4 weeks but not at 1 year .
CONCLUSIONS	On the basis of these findings , we conclude that CNI is not a trivial consequence of CEA but rarely results in significant long-term disability .

###25016244
BACKGROUND	Changes in the levels of lipids are associated with breast cancer ( BC ) .
METHODS	Disease-specific serum free fatty acids ( FFAs ) were quantified using chip-based direct-infusion nanoelectrospray ionization-Fourier transform ion cyclotron resonance mass spectrometry ( CBDInanoESI-FTICR MS ) in the negative ion mode .
METHODS	Multiple point internal standard calibration curves between the concentration ratios of fatty acids ( i.e. , C16 :1 , C18 :3 , C18 :2 , C18 :1 , C20 :4 , and C22 :6 ) to internal standards ( C17 :1 for C16 :1 , C18 :3 , C18 :2 , and C18 :1 , C21 :0 for C20 :4 and C22 :6 ) and their corresponding intensity ratios were established with a correlation coefficient of greater than 0.986 .
RESULTS	Data from 342 serum samples including 202 healthy controls and 140 BC patients indicate that serum concentrations of FFAs in patients with BC were significantly decreased compared with those in healthy controls .
RESULTS	A panel of C16 :1 , C18 :3 , C18 :2 , C20 :4 , and C22 :6 showed an excellent diagnostic ability to differentiate the patients with early stage BC from healthy controls , with the area under the receiver operating characteristics ( ROC ) curve of 0.953 , a sensitivity of 83.3 % , and a specificity of 87.1 % .
CONCLUSIONS	Our findings suggest that these FFAs may be a valuable biomarker panel for the early-stage detection of BC .

###25040613
BACKGROUND	Inhaled glucocorticosteroids ( ICS ) are the mainstay of treatment in asthma .
BACKGROUND	Fluticasone furoate ( FF ) is a novel , once-daily ICS asthma therapy .
BACKGROUND	This study investigated the efficacy and safety of FF50mcg in patients with mild-to-moderate persistent asthma .
METHODS	A 24-week , multicenter , randomized , placebo-controlled and active-controlled , double-blind , double-dummy , parallel-group phase III study .
METHODS	Three hundred and fifty-one patients ( aged 12years ; uncontrolled by non-ICS therapy ) were randomized to treatment ( 1:1:1 ) with once-daily FF50mcg dosed in the evening , twice-daily fluticasone propionate ( FP ) 100mcg or placebo .
METHODS	The primary endpoint was change from baseline in evening trough forced expiratory volume in 1s ( FEV1 ) at Week24 .
METHODS	Secondary endpoints were change from baseline in the percentage of rescue-free 24-h periods ( powered endpoint ) , change from baseline in evening and morning peak expiratory flow , change from baseline in the percentage of symptom-free 24-h periods and number of withdrawals due to lack of efficacy .
RESULTS	Evening trough FEV1 at Week 24 was not statistically significantly increased with FF 50mcg once-daily ( 37ml [ 95 % CI : -55 , 128 ] ; P = 0.430 ) , but was with FP 100mcg twice daily ( 102ml [ 10 , 194 ] ; P = 0.030 ) , vs placebo .
RESULTS	No consistent trends were observed across other endpoints , including the powered secondary endpoint .
RESULTS	No safety concerns were raised for either active treatment .
CONCLUSIONS	FP 100mcg twice daily improved evening trough FEV1 in patients with mild-to-moderate persistent asthma , but FF 50mcg once daily did not demonstrate a significant effect .
CONCLUSIONS	Secondary endpoints showed variable results .
CONCLUSIONS	No safety concerns were identified for FF or FP .

###25052130
BACKGROUND	A prophylactic antibiotic is recommended in open cholecystectomy surgeries , but in laparoscopic cholecystectomies such prophylaxis is controversial .
BACKGROUND	Recent reviews have not found conclusive evidence that routine prophylaxis , especially in low risk patients , is effective .
BACKGROUND	This clinical trial was undertaken to evaluate the efficacy of cefazolin in reducing surgical site infection SSI in laparoscopic cholecystectomies in a sample not screened for high or low risk patients .
METHODS	A randomized double-blind controlled trial was conducted in a single university hospital .
METHODS	Scheduled cholecystectomy patients without selection for patient risk factors were randomized into two groups .
METHODS	Pre-operatively , group A patients received a placebo of 10ml isotonic sodium chloride , and group B patients received 1g of cefazolin as a prophylactic antibiotic .
METHODS	All patients underwent a standard laparoscopic cholecystectomy , and were followed up for at least 30days .
RESULTS	Two hundred ninety-nine patients were randomized ( 149 in group A and 150 in group B ) .
RESULTS	SSI occurred in seven patients ( 2.34 % ) , five ( 1.67 % ) in the placebo group , and two ( 0.67 % ) in the prophylactic antibiotic group .
RESULTS	The difference was not statistically significant ( p value = 0.512 ) , and no specific risk factors for post-operative infection were identified .
CONCLUSIONS	A single dose of preoperative prophylactic cefazolin has no significant benefit in reducing the incidence of SSI in laparoscopic cholecystectomy .
CONCLUSIONS	Whether or not to use a prophylactic depends on the individual patient , and the consideration of the attending surgeon .

###25153429
OBJECTIVE	The purpose of this study was to test the effectiveness of an online problem-based learning ( e-PBL ) program that offers multimedia scenarios to develop sexual health care competencies .
METHODS	A pretestposttest control group design was used with two randomized groups in one Korean tertiary hospital .
METHODS	The sample included 32 RNs who cared for oncology patients .
METHODS	The intervention group completed an e-PBL cycle consisting of eight tutorials .
RESULTS	Nurses in the intervention group scored significantly higher on knowledge than did those in the control group .
RESULTS	The intervention group exhibited no significant differences in attitude and practices following the intervention .
CONCLUSIONS	The results show the potential of e-PBL to enhance traditional PBL by offering multimedia scenarios in an interactive and flexible learning environment .

###25524487
OBJECTIVE	To determine whether children with type 1 diabetes mellitus ( T1DM ) have evidence of increased aortic stiffness or early atherosclerosis as measured by magnetic resonance imaging ( MRI ) .
BACKGROUND	T1DM increases risk for cardiovascular disease in adults but whether this process starts in childhood is unknown .
METHODS	A total of 54 T1DM patients ( 15.4 2.6 yr ) and 30 age-matched controls ( 14.8 2.7 yr ) participated .
METHODS	MRI was performed to assess aortic arch pulse wave velocity ( PWV ) , strain , and distensibility of the ascending and descending thoracic aorta and measures of atherosclerosis .
RESULTS	Groups were well-matched for age , pulse pressure , and gender .
RESULTS	Low-density lipoprotein-cholesterol ( LDL-C ) was higher in T1DM ( 119.3 50 vs. 76.1 13.5 mg/dL , p < 0.0001 ) .
RESULTS	There was a trend toward decreased strain and distensibility in T1DM vs. controls in the ascending ( distensibility : T1DM 62.2 19.9 kPa 10 , control 71.6 26.4 kPa 10 , p = 0.08 ) and descending aorta ( strain : T1DM 25.8 6.2 % vs. control 28.3 6.8 % , p = 0.09 ) .
RESULTS	There was no difference in arch PWV .
RESULTS	Advancing age and male gender was negatively associated with aortic stiffness .
RESULTS	Hemoglobin A1c ( HbA1c ) was inversely related to descending aorta strain and distensibility ( p < 0.05 ) .
RESULTS	Children with diabetes in the lowest two tertiles of insulin sensitivity demonstrated thoracic descending aortas with significantly lower strain ( p = 0.027 ) and distensibility ( p = 0.039 ) and increased measures of wall irregularity ( p = 0.005 ) .
RESULTS	There were no differences in measurements of atherosclerosis between the two groups .
CONCLUSIONS	Adolescents with T1DM , especially those with lower insulin sensitivity , demonstrated a trend toward stiffer , less compliant thoracic aortas , which was inversely associated with diabetes control .
CONCLUSIONS	These data suggest large vessel aortopathy starts early in T1DM .

###25119339
BACKGROUND	The homeostatic mechanisms of iron metabolism and erythropoiesis in infants are unclear .
BACKGROUND	Infants synthesize both fetal hemoglobin ( HbF ) and adult hemoglobin ( HbA ) , and it is not known how the hemoglobin switch is regulated .
BACKGROUND	We hypothesized that iron supplements to infants affect the disappearance of HbF .
METHODS	We randomized 285 low-birth-weight infants ( 2,000-2 ,500 g ) into three intervention groups receiving 0 , 1 , or 2mg/kg/d of iron supplements from 6wk to 6 mo of age .
METHODS	In the present secondary analysis , we analyzed iron status , total hemoglobin ( Hb ) , and HbF fraction at 6wk , 12wk , and at 6 mo and calculated absolute levels of HbF .
RESULTS	We observed dose-dependent increased levels of Hb in iron-supplemented groups at 6 mo of age .
RESULTS	However , for absolute HbF concentration , there was no similar effect of intervention .
RESULTS	Mean ( SD ) HbF was 81.2 ( 16.8 ) , 37.0 ( 13.8 ) , and 8.1 ( 5.6 ) g/l at 6wk , 12wk , and 6 mo , respectively , similar in all groups .
RESULTS	In linear regression analyses , postconceptional age turned out as the major predictor of HbF , independent of gestational age at birth .
CONCLUSIONS	Our hypothesis was rejected .
CONCLUSIONS	Instead , we confirmed a close correlation to postconceptional age , supporting a genetically programmed switch , insensitive to most environmental factors including birth .

###25026897
BACKGROUND	Dose-dense sequential chemotherapy including anthracyclines and taxanes has been established in the adjuvant setting of high-risk operable breast cancer .
BACKGROUND	However , the preferable taxane and optimal schedule of administration in a dose-dense regimen have not been defined yet .
METHODS	From July 2005 to November 2008 , 1001 patients ( 990 eligible ) were randomized to receive , every 2 weeks , 3 cycles of epirubicin 110 mg/m2 followed by 3 cycles of paclitaxel 200 mg/m2 followed by 3 cycles of intensified CMF ( Arm A ; 333 patients ) , or 3 cycles of epirubicin followed by 3 cycles of CMF , as in Arm A , followed 3 weeks later by 9 weekly cycles of docetaxel 35 mg/m2 ( Arm B ; 331 ) , or 9 weekly cycles of paclitaxel 80 mg/m2 ( Arm C ; 326 ) .
METHODS	Trastuzumab was administered for one year to HER2-positive patients post-radiation .
RESULTS	At a median follow-up of 60.5 months , the 3-year disease-free survival ( DFS ) rate was 86 % , 90 % and 88 % , for Arms A , B and C , respectively , while the 3-year overall survival ( OS ) rate was 96 % in all arms .
RESULTS	No differences were found in DFS or OS between the combined B and C Arms versus Arm A ( DFS : HR = 0.81 , 95 % CI : 0.59-1 .11 , P = 0.20 ; OS : HR = 0.84 , 95 % CI : 0.55-1 .30 , P = 0.43 ) .
RESULTS	Among the 255 patients who received trastuzumab , 189 patients ( 74 % ) completed 1 year of treatment uneventfully .
RESULTS	In all arms , the most frequently reported severe adverse events were neutropenia ( 30 % vs. 27 % vs. 26 % ) and leucopenia ( 12 % vs. 13 % vs. 12 % ) , while febrile neutropenia occurred in fifty-one patients ( 6 % vs. 4 % vs. 5 % ) .
RESULTS	Patients in Arm A experienced more often severe pain ( P = 0.002 ) , neurological complications ( P = 0.004 ) and allergic reactions ( P = 0.004 ) , while patients in Arm B suffered more often from severe skin reactions ( P = 0.020 ) .
CONCLUSIONS	No significant differences in survival between the regimens were found in the present phase III trial .
CONCLUSIONS	Taxane scheduling influenced the type of severe toxicities .
CONCLUSIONS	HER2-positive patients demonstrated comparable 3-year DFS and OS rates with those reported in other similar studies .
BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12610000151033 .

###25099545
BACKGROUND	Protein-rich supplements are used widely for the prevention and management of undernutrition in older people .
BACKGROUND	The use of protein supplements in older people could , however , be counterproductive by reducing appetite and overall energy intake .
OBJECTIVE	The objective was to determine whether aging influences the effects of protein loads , administered directly into the small intestine , on energy intake , antropyloroduodenal motility , and appetite .
METHODS	Intraduodenal infusions ( 240 mL , 60 min ) of saline ( 0 kcal , control ) and protein ( hydrolyzed whey ) loads of 30 , 90 , and 180 kcal were followed by an ad libitum buffet meal in 10 young ( 19-29 y ) and 10 healthy older ( 68-81 y ) men .
METHODS	Suppression of energy intake ( kcal ) at the meal by protein infusion compared with control was calculated .
RESULTS	In young subjects , a dose-responsive suppression ( SEM ) of energy intake was found at the buffet meal by protein ( suppression at 30 kcal : 7 8 % , P = 0.189 ; 90 kcal : 17 8 % , P = 0.054 ; 180 kcal : 33 7 % , P = 0.002 ) , whereas suppression was observed only after the 180-kcal load in older subjects ( 30 kcal : 7 4 % increase , P = 0.126 ; 90 kcal : 6 7 % increase , P = 0.291 ; 180 kcal : 17 6 % suppression , P = 0.016 ) .
RESULTS	Suppression of energy intake by protein was less in older than in young subjects ( P < 0.005 ) .
RESULTS	In young subjects , total energy intake ( meal + infusion ) on the 180-kcal protein-infusion day was lower than that on the control day ( P = 0.041 ) , whereas in older subjects it was greater on the 30-kcal ( P = 0.033 ) and 90-kcal ( P = 0.016 ) infusion days .
RESULTS	Energy intake was inversely related to isolated pyloric pressure waves ( r = -0.32 , P = 0.013 ) and positively related to antral ( r = 0.30 , P = 0.021 ) and duodenal ( r = 0.35 , P = 0.006 ) pressure waves .
RESULTS	Suppression of energy intake by protein was inversely related to the change in isolated pyloric pressure waves ( r = -0.35 , P = 0.027 ) and positively related to duodenal pressure waves ( r = 0.32 , P = 0.044 ) .
CONCLUSIONS	Intraduodenal protein suppresses appetite and energy intake less in healthy older than in young adults .
CONCLUSIONS	In older subjects , intraduodenal protein at low doses increased overall energy intake , which supports the use of protein supplements in undernourished older people .
CONCLUSIONS	This trial was registered at www.anzctr.org.au as 12612000906853 .

###25296066
OBJECTIVE	To determine whether internet-delivered cognitive behaviour therapy ( iCBT ) for depression and anxiety reduces self-reported absenteeism in employed individuals .
METHODS	We reanalysed data from five randomised controlled trials of iCBT : two for depression ( conducted from September 2008 to February 2009 and from June 2009 to January 2010 ) , two for generalised anxiety disorder ( conducted from March 2009 to June 2009 and from July 2009 to January 2010 ) and one for social phobia ( conducted from May 2008 to July 2008 ) .
METHODS	Participants across Australia were recruited via a website .
METHODS	The inclusion criteria were : ( i ) meets criteria for the disorder of interest ; ( ii ) aged 18 years or over ; ( iii ) no previous history of a psychotic disorder or drug or alcohol misuse ; ( iv ) not actively suicidal .
METHODS	The iCBT courses each consisted of six online lessons ( to be completed within 11 weeks ) , homework assignments , automatic emails and resource documents .
METHODS	The number of days absent ( self-reported absenteeism ) in the previous week .
RESULTS	We included 284 participants in our analysis .
RESULTS	When data for the three disorders were combined , participants who received iCBT had significant reductions in self-reported absenteeism compared with those in the control groups ( who were on a waitlist ) ( P = 0.03 ) .
RESULTS	When data for the three disorders were analysed separately , reductions in self-reported absenteeism for participants who received iCBT were not significantly different to those for participants in the control groups .
CONCLUSIONS	Using data from five RCTs , we showed that iCBT was associated with reductions in self-reported absenteeism .
CONCLUSIONS	Future research should focus on replicating these findings in other contexts , such as other disorders and other iCBT courses .

###25330687
OBJECTIVE	To compare the combination spironolactone-norgestimate-ethinyl estradiol in hirsutism with other protocols including the same dose of estrogen .
METHODS	In this open prospective study , 167 women with hirsutism due to polycystic ovary syndrome ( PCOS ) were randomly assigned to the following treatment protocols : Group A ( n = 72 ) : spironolactone 100 mg-norgestimate 250 mcg-ethinyl estradiol 35 microg ; Group B ( n = 70 ) : cyproterone acetate 12 mg-ethinyl estradiol 35 microg ; Group C ( n = 25 ) : norgestimate 250 microg-ethinyl estradiol 35 microg .
RESULTS	The decrease in the hirsutism score was higher in group A than in the other groups ( p < 0.001 ) and comparable in groups B and C.
RESULTS	The decrease in acne score , androgen and estradiol levels , and ovary volume was similar in groups A and B. C-reactive protein increase was similar in all groups , but the augmentation of fibrinogen ( p = 0.04 ) , triglycerides ( p < 0.01 ) , monocyte count ( p = 0.04 ) , platelet number ( p < 0.001 ) and mean volume ( p = 0.01 ) was more pronounced in group B than in group A. Low-density lipoprotein/high-density lipoprotein cholesterol ratio decreased in groups A and C.
CONCLUSIONS	Spironolactone-norgestimate-ethinyl estradiol is an effective and well-tolerated combination for the treatment of hirsutism in PCOS , with a favorable influence on lipids and indices of low-grade inflammation .

###24331203
BACKGROUND	Lowering dietary sodium and adhering to medication regimens are difficult for persons with heart failure ( HF ) .
BACKGROUND	Because these behaviors often occur within the family context , this study evaluated the effects of family education and partnership interventions on dietary sodium ( Na ) intake and medication adherence ( MA ) .
RESULTS	HF patient and family member ( FM ) dyads ( n = 117 ) were randomized to : usual care ( UC ) , patient-FM education ( PFE ) , or family partnership intervention ( FPI ) .
RESULTS	Dietary Na ( 3-day food record ) , urinary Na ( 24-hour urine ) , and MA ( Medication Events Monitoring System ) were measured at baseline ( BL ) before randomization , and at 4 and 8 months .
RESULTS	FPI and PFE reduced urinary Na at 4 months , and FPI differed from UC at 8 months ( P = .016 ) .
RESULTS	Dietary Na decreased from BL to 4 months , with both PFE ( P = .04 ) and FPI ( P = .018 ) lower than UC .
RESULTS	The proportion of subjects adherent to Na intake ( 2,500 mg/d ) was higher at 8 months in PFE and FPI than in UC ( ( 2 ) ( 2 ) = 7.076 ; P = .029 ) .
RESULTS	MA did not differ among groups across time .
RESULTS	Both FPI and PFE groups increased HF knowledge immediately after intervention .
CONCLUSIONS	Dietary Na intake , but not MA , was improved by PFE and FPI compared with UC .
CONCLUSIONS	The UC group was less likely to be adherent with dietary Na .
CONCLUSIONS	Greater efforts to study and incorporate family-focused education and support interventions into HF care are warranted .

###25493602
OBJECTIVE	To evaluate preexposure prophylaxis ( PrEP ) efficacy for HIV-1 prevention among women using depot medroxyprogesterone acetate ( DMPA ) for contraception and men whose HIV-1-infected partners use DMPA .
METHODS	Secondary analysis of data from a randomized placebo-controlled trial of daily oral tenofovir and emtricitabine/tenofovir PrEP among heterosexual Kenyan and Ugandan HIV-1 serodiscordant couples .
METHODS	PrEP efficacy for HIV-1 prevention was compared among HIV-1-uninfected women using DMPA versus no hormonal contraception and among HIV-1 uninfected men whose HIV-1-infected female partners used DMPA versus no hormonal contraception .
RESULTS	Of 4747 HIV-1 serodiscordant couples , 901 HIV-1-uninfected women used DMPA at some point during follow-up , 1422 HIV-1-uninfected women used no hormonal contraception , 1568 HIV-1-uninfected men had female partners who used DMPA , and 2626 men had female partners who used no hormonal contraception .
RESULTS	PrEP efficacy estimates for HIV-1 prevention , compared with placebo , were similar among women using DMPA and those using no hormonal contraception ( 64.7 and 75.5 % , adjusted interaction P = 0.65 ) .
RESULTS	Similarly , for men whose female partners used DMPA , PrEP efficacy did not differ from men whose partners used no hormonal contraception ( 90.0 versus 81.7 % , adjusted interaction P = 0.52 ) .
CONCLUSIONS	PrEP is efficacious for HIV-1 prevention among women using DMPA and men whose partners use DMPA , suggesting PrEP could mitigate the potential increased HIV-1 acquisition and transmission risks that have been associated with DMPA use .
CONCLUSIONS	Women at risk for HIV-1 choosing DMPA could maintain this contraceptive method and add PrEP to achieve prevention of unintended pregnancy and HIV-1 .

###25494343
BACKGROUND	The Verband Deutscher Rentenversicherungstrger ( VDR ) required the intense focus on vocational rehabilitation of medical problems since the early 1990s .
BACKGROUND	By integrating elements of the working environment in the structures and processes of medical rehabilitation , vocational problems can be identified early in order to take appropriate countermeasures .
BACKGROUND	Posttreatment proposals off er a way to provide a reliable long-term success .
OBJECTIVE	The intention of this study is the implementation and the investigation of effectiveness of an intensified vocational program that integrates besides the in-patient rehabilitation post-treatment proposals as well .
METHODS	Cardiac rehabilitation patient occurring special vocational problems participe .
METHODS	The recruited patients were randomized to either the vocational program or the common cardiac rehabilitation.Primary outcome was the vocational reintegration 12 months after the end of rehabilitation.The database was collected through a query of the pension insurance accounts and questionnaires .
RESULTS	306 people were included to the study at the beginning of rehabilitation .
RESULTS	Rates of response :95 % of the survey to the end of rehabilitation ,77 % of the survey 6 months and 73 % of the survey 12 months after the end of rehabilitation.The sample was characterized by great interferences of their professional involvement and a high demand for vocational treatments .
RESULTS	At the beginning of the rehabilitation 50 % of study participants intended to make an application for reduction-pension .
RESULTS	Nevertheless , one year after the end of rehabilitation a surprisingly high rate of vocational reintegration by over 70 % in both groups ( IG : 72 % , KG : 75 % , p < 0.929 ) was indicated.The majority of the unemployed patients at the beginning of rehabilitation remained in the unemployment ( IG : 69 % , KG : 65 % , p < 0.757 ) .
RESULTS	The participation rate at the post-treatment proposals was 42 % .
CONCLUSIONS	The results show that vocational programs in rehabilitation need to be revised , including with regard to the question , whether and in what way post-treatment proposals must be changed .

###25532501
BACKGROUND	Long-term tenofovir disoproxil fumarate ( TDF ) treatment for chronic hepatitis B ( CHB ) is associated with sustained viral suppression and regression of fibrosis and cirrhosis at year 5 ( 240 weeks ) and no TDF resistance through 6 years ( 288 weeks ) .
OBJECTIVE	We assessed the efficacy , safety , and resistance of TDF for up to 7 years ( 336 weeks ) in HBeAg-positive and HBeAg-negative CHB patients .
METHODS	Patients who completed 1 year ( 48 weeks ) of randomized treatment with TDF or adefovir dipivoxil were eligible to receive open-label TDF for a total duration of 8 years ( 384 weeks ) .
RESULTS	Of 641 patients initially randomized , 585 ( 91.3 % ) entered the open-label phase ; 437/585 ( 74.7 % ) remained on study at year 7 .
RESULTS	For patients on treatment at year 7 , 99.3 % maintained viral suppression ( HBV DNA < 69 IU/mL ) , 80.0 % achieved serum alanine aminotransferase normalization , and in HBeAg-positive patients , 84/154 ( 54.5 % ) and 25/154 ( 11.8 % ) achieved HBeAg and HBsAg loss , respectively .
RESULTS	One/375 ( 0.3 % ) HBeAg-negative patients achieved HBsAg loss .
RESULTS	No resistance to TDF was detected through 7 years .
RESULTS	During the open-label phase , grade 3/4 drug-related adverse events were uncommon ( 1.0 % ) ; ten ( 1.7 % ) patients had elevation of serum creatinine 0.5 mg/dL above baseline .
RESULTS	No significant change in bone mineral density was observed from year 4 to year 7 ( week 192 to week 336 ) .
CONCLUSIONS	Long-term TDF treatment was associated with sustained virologic , biochemical , and serologic responses , without resistance .
CONCLUSIONS	TDF treatment was well tolerated , with a low incidence of renal and bone events .
CONCLUSIONS	These data confirm the safety and efficacy of long-term TDF for CHB .

###26208461
OBJECTIVE	The aims of this analysis were to examine levels of unmet needs and depression among carers of people newly diagnosed with cancer and to identify groups who may be at higher risk , by examining relationships with demographic characteristics .
METHODS	One hundred and fifty dyads of people newly diagnosed with cancer and their carers , aged 18 years and older , were recruited from four Australian hospitals .
METHODS	People with cancer receiving adjuvant cancer treatment with curative intent , were eligible to participate .
METHODS	Carers completed the Supportive Care Needs Survey-Partners & Caregivers ( SCNS-P & C45 ) , and both carers and patients completed the Centre of Epidemiologic-Depression Scale ( CES-D ) .
RESULTS	Overall , 57 % of carers reported at least one , 37 % at least three , 31 % at least five , and 15 % at least 10 unmet needs ; the most commonly endorsed unmet needs were in the domains of information and health care service needs .
RESULTS	Thirty percent of carers and 36 % of patients were at risk of clinical depression .
RESULTS	A weak to moderate positive relationship was observed between unmet needs and carer depression ( r = 0.30 , p < 0.001 ) .
RESULTS	Carer levels of unmet needs were significantly associated with carer age , hospital type , treatment type , cancer type , living situation , relationship status ( in both uni - and multi-factor analysis ) ; person with cancer age and carer level of education ( in unifactor analysis only ) ; but not with carer gender or patient gender ( in both uni - and multi-factor analyses ) .
CONCLUSIONS	Findings highlight the importance of developing tailored programmes to systematically assist carers who are supporting patients through the early stages of cancer treatment .

###25197804
OBJECTIVE	To further our understanding of central sleep apnea ( CSA ) at high altitude during acclimatization , we tested the hypothesis that pharmacologically altering cerebral blood flow ( CBF ) would alter the severity of CSA at high altitude .
METHODS	The study was a randomized , placebo-controlled single-blind study .
METHODS	A field study at 5,050 m in Nepal .
METHODS	We studied 12 normal volunteers .
METHODS	Between days 5 to 10 at high altitude , CBF velocity ( CBFv ) was increased by intravenous ( IV ) acetazolamide ( 10 mg/kg ) and reduced by oral indomethacin ( 100 mg ) .
RESULTS	Arterial blood gases , hypoxic and hypercapnic ventilatory responses , and CBFv and its reactivity to carbon dioxide were measured awake .
RESULTS	Overnight polysomnography was performed .
RESULTS	The central apnea-hypopnea index was elevated following administration of indomethacin ( 89.2 43.7 to 112.5 32.9 events/h ; mean standard deviation ; P < 0.05 ) and was reduced following IV acetazolamide ( 89.2 43.7 to 47.1 48.1 events/h ; P < 0.001 ) .
RESULTS	Intravenous acetazolamide elevated CBFv at high altitude by 28 % ( 95 % confidence interval [ CI ] : 22-34 % ) but did not affect ventilatory responses .
RESULTS	The elevation in CBFv was partly mediated via a selective rise in partial pressure of arterial carbon dioxide ( PaCO2 ) ( 28 4 to 31 3 mm Hg ) and an associated fall in pH ( P < 0.01 ) .
RESULTS	Oral indomethacin reduced CBFv by 23 % ( 95 % CI : 16-30 % ) , blunted CBFv reactivity , and increased the hypercapnic ventilatory response by 66 % ( 95 % CI : 30-102 % ) but had no effect on PaCO2 or pH.
CONCLUSIONS	Our findings indicate an important role for cerebral blood flow regulation in the pathophysiology of central sleep apnea at high altitude .

###25158865
BACKGROUND	Dipeptidyl-peptidase 4 ( DPP4 ) inhibitors improve glycemic control in patients with diabetes mellitus by preventing the degradation of glucagon-like peptide-1 ( GLP-1 ) .
BACKGROUND	GLP-1 causes vasodilation in animal models but also increases sympathetic activity ; the effect of GLP-1 in the human vasculature and how it is altered by DPP4 inhibition is not known .
BACKGROUND	DPP4 also degrades the vasodilator brain natriuretic peptide ( BNP ) to a less potent metabolite .
BACKGROUND	This study tested the hypothesis that DPP4 inhibition potentiates the vasodilator responses to GLP-1 and BNP in the human forearm .
RESULTS	Seventeen healthy subjects participated in this randomized , double-blinded , placebo-controlled crossover study .
RESULTS	On each study day , subjects received DPP4 inhibitor ( sitagliptin 200 mg by mouth ) or placebo .
RESULTS	Sitagliptin increased forearm blood flow and decreased forearm vascular resistance without affecting mean arterial pressure and pulse .
RESULTS	GLP-1 and BNP were infused in incremental doses via brachial artery .
RESULTS	Venous GLP-1 concentrations were significantly higher during sitagliptin use , yet there was no effect of GLP-1 on forearm blood flow in the presence or absence of sitagliptin .
RESULTS	BNP caused dose-dependent vasodilation ; however , sitagliptin did not affect this response .
RESULTS	GLP-1 and BNP had no effect on net norepinephrine release .
CONCLUSIONS	These data suggest that GLP-1 does not act as a direct vasodilator in humans and does not contribute to sympathetic activation .
CONCLUSIONS	Sitagliptin does not regulate vascular function in healthy humans by affecting the degradation of GLP-1 and BNP .
BACKGROUND	www.clinicaltrials.gov / Unique identifier : NCT01413542 .

###24325052
OBJECTIVE	To observe the efficacy of thread-moxa in Zhuang folk medicine ( TM ) combined with acupuncture and external application drugs for AIDS patients with herpes zoster ( AHZ ) .
METHODS	A randomized , controlled clinical trial was conducted in 60 patients with AHZ .
METHODS	They were randomly assigned to the treatment group ( treated with TM combined with acupuncture and Jingwanhong Scald Ointment ) and the control group ( treated with Famciclovir Tablet , nimesulide dispersible tablet , vitamin B1 , ribavirin ointment ) .
METHODS	The treatment course was 14 days for both groups.The clinical efficacy , significant efficiency visual analog scale score ( VAS ) , sleep quality score ( QS ) , the postherpetic neuralgia rate in 1 year after treatment were observed .
RESULTS	The markedly effective rate was significantly higher in the treatment group than in the control group ( 86.7 % vs. 53.3 % , P < 0.01 ) .
RESULTS	There was no statistical difference in the total effective rate between the two groups ( 96.7 % vs. 80.0 % , P > 0.05 ) .
RESULTS	The post-treatment VAS , QS , the time for pain disappearance , skin repair , crusting , and 1-year postherpetic neuralgia incidence rate were significantly lower in the treatment group than in the control group ( P < 0.05 , P < 0.01 ) .
CONCLUSIONS	TM combined with acupuncture and Jingwanhong Scald Ointment was effective for treating AHZ patients .
CONCLUSIONS	It relieved pain quickly , shortened their course of disease , and improved their quality of sleep .

###25033919
OBJECTIVE	To determine whether acupuncture is effective as an overactive bladder ( OAB ) treatment compared with solifenacin and placebo , and to investigate its relation with urine nerve growth factor ( NGF ) levels .
METHODS	The study was conducted with methodological rigor based on the Consolidated Standards of Reporting Trials criteria .
METHODS	90 female patients with OAB were included and randomly assigned to a solifenacin , acupuncture or placebo group .
METHODS	The medicated group received solifenacin 5 mg/day ; the acupuncture and placebo groups were treated twice a week for 4 weeks .
METHODS	Symptom scores , quality of life scores , frequency of micturition and urine NGF levels were used to assess treatment efficiency .
RESULTS	The study was completed with 82 patients ( n = 30 in the solifenacin group , n = 28 in the acupuncture group and n = 24 in the placebo group ) .
RESULTS	After treatment , comparison of the medical and acupuncture therapy groups with the placebo group showed significant differences between recovery concerning quality of life ( p < 0.001 and p < 0.01 , respectively ) and symptom scores ( p < 0.001 and p < 0.001 , respectively ) .
RESULTS	The decrease of NGF levels after treatment compared to before treatment was determined in each group ( solifenacin , acupuncture , placebo group ; p < 0.001 , p < 0.001 , p = 0.359 , respectively ) .
RESULTS	Sufficient symptomatic improvement was not achieved in 8 patients in the acupuncture group .
RESULTS	Therefore , comparisons were assessed twice with and without including these patients , and NGF levels in the acupuncture group were higher than at first comparison in which all patients in the acupuncture group were included .
CONCLUSIONS	In patients with OAB in whom anticholinergic treatment is contraindicated , acupuncture may be considered another treatment option .

###25139116
OBJECTIVE	To explore whether subjects harbouring A. actinomycetemcomitans , P. gingivalis or T. forsythia at baseline showed increased clinical benefits with the adjunctive use of systemic amoxicillin and metronidazole ( AMX-MET ) during non-surgical treatment of generalized aggressive periodontitis ( GAgP ) .
METHODS	Forty one subjects were included in this 6-month randomized placebo-controlled clinical trial using a 7-day course of systemic AMX-MET or placebo as adjuncts to non-surgical periodontal therapy .
METHODS	Clinical and microbiological parameters were collected at baseline , 2 and 6months after treatment .
METHODS	Microbiological cultures were processed for pooled subgingival samples and identities of isolates were determined by PCR for A. actinomycetemcomitans , P. gingivalis and T. forsythia
RESULTS	At 6months , the test treatment resulted in significant additional improvements in the primary outcome variable compared to placebo , and the effect of the adjunctive antimicrobials was not modified by the baseline microbiological status in the primary analysis .
RESULTS	However , secondary exploratory subgroup analyses showed improved clinical outcomes in subjects harbouring A. actinomycetemcomitans at baseline compared to subjects who did not harbour this pathogen .
CONCLUSIONS	All subjects benefited from the tested adjunctive antimicrobial regimen , although subjects who harboured A. actinomycetemcomitans at baseline may show greater clinical benefits .
CONCLUSIONS	Larger appropriately powered studies are needed to confirm whether adjunctive AMX-MET is more beneficial for GAgP patients who harbour A. actinomycetemcomitans , along with other key periodontal pathogens .

###25401419
BACKGROUND	The authors investigated the effect of remifentanil administration on resting electroencephalography functional connectivity and its relationship to cognitive function and analgesia in healthy volunteers .
METHODS	Twenty-one healthy male adult subjects were enrolled in this placebo-controlled double-blind cross-over study .
METHODS	For each subject , 2.5 min of multichannel electroencephalography recording , a cognitive test of sustained attention ( continuous reaction time ) , and experimental pain scores to bone-pressure and heat stimuli were collected before and after infusion of remifentanil or placebo .
METHODS	A coherence matrix was calculated from the electroencephalogram , and three graph-theoretical measures ( characteristic path-length , mean clustering coefficient , and relative small-worldness ) were extracted to characterize the overall cortical network properties .
RESULTS	Compared to placebo , most graph-theoretical measures were significantly altered by remifentanil at the alpha and low beta range ( 8 to 18 Hz ; all P < 0.001 ) .
RESULTS	Taken together , these alterations were characterized by an increase in the characteristic path-length ( alpha 17 % and low beta range 24 % ) and corresponding decrements in mean clustering coefficient ( low beta range -25 % ) and relative small-worldness ( alpha -17 % and low beta range -42 % ) .
RESULTS	Changes in characteristic path-lengths after remifentanil infusion were correlated to the continuous reaction time index ( r = -0.57 ; P = 0.009 ) , while no significant correlations between graph-theoretical measures and experimental pain tests were seen .
CONCLUSIONS	Remifentanil disrupts the functional connectivity network properties of the electroencephalogram .
CONCLUSIONS	The findings give new insight into how opioids interfere with the normal brain functions and have the potential to be biomarkers for the sedative effects of opioids in different clinical settings .

###24445573
OBJECTIVE	Patients with several painful functional gastrointestinal disorders ( FGIDs ) are reported to have a high prevalence of psychosocial disturbance .
OBJECTIVE	These aspects have not been studied extensively in patients with suspected Sphincter of Oddi dysfunction ( SOD ) .
METHODS	A total of 214 patients with post-cholecystectomy pain and suspected SOD were enrolled in seven US centers in a multicenter-randomized trial ( Evaluating Predictors and Interventions in Sphincter of Oddi Dysfunction ) .
METHODS	Baseline assessments included pain descriptors and burden , structured psychosocial assessments of anxiety/depression , coping , trauma , and health-related quality of life .
METHODS	Patients with high levels of depression , suicidal ideation , or psychosis were excluded .
RESULTS	The study population ( 92 % female , mean age 38 ) reported anxiety ( 9 % ) , depression ( 8 % ) , past sexual trauma ( 18 % ) , and physical abuse ( 10 % ) .
RESULTS	Of the total screened population ( n = 1460 ) , 3.9 % of the patients were excluded because of the presence of defined severe psychological problems .
RESULTS	The mean medical outcomes study short-form-36 ( SF-36 ) physical and mental composite scores were 38.70 ( s.d. = 7.89 ) and 48.74 ( s.d. = 9.60 ) , respectively .
RESULTS	Most subjects reported symptoms of other FGIDs .
RESULTS	There were no correlations between the extent of the pain burden in the 3 months before enrollment and the baseline anxiety scores or victimization history .
RESULTS	However , those with greater pain burden were significantly more depressed .
RESULTS	There were no meaningful differences in the psychosocial parameters in subjects with or without irritable bowel , and those who had cholecystectomy for stones or functional gallbladder disease .
RESULTS	Those declining randomization were comparable to those randomized .
CONCLUSIONS	Psychosocial comorbidity in SOD is high .
CONCLUSIONS	However , it does not appear to differ significantly from that reported in surveys of age - and gender-matched general populations , and may be lower than reported with other FGIDs .

###25276591
BACKGROUND	Neonatal sepsis is a major cause of neonatal mortality .
BACKGROUND	In populations with limited access to health care , early identification of bacterial infections and initiation of antibiotics by community health workers ( CHWs ) could be lifesaving .
BACKGROUND	It is unknown whether this strategy would be feasible using traditional birth attendants ( TBAs ) , a cadre of CHWs who typically have limited training and educational backgrounds .
METHODS	We analyzed data from the intervention arm of a cluster-randomized trial involving TBAs in Lufwanyama District , Zambia , from June 2006 to November 2008 .
METHODS	TBAs followed neonates for signs of potential infection through 28 days of life .
METHODS	If any of 16 criteria were met , TBAs administered oral amoxicillin and facilitated referral to a rural health center .
RESULTS	Our analysis included 1,889 neonates with final vital status by day 28 .
RESULTS	TBAs conducted a median of 2 ( interquartile range 2-6 ) home visits ( 51.4 % in week 1 and 48.2 % in weeks 2-4 ) and referred 208 neonates ( 11 % ) for suspected sepsis .
RESULTS	Of referred neonates , 176/208 ( 84.6 % ) completed their referral .
RESULTS	Among neonates given amoxicillin , 171/183 ( 93.4 % ) were referred ; among referred neonates , 171/208 ( 82.2 % ) received amoxicillin .
RESULTS	Referral and/or initiation of antibiotics were strongly associated with neonatal death ( for referral , relative risk [ RR ] = 7.93 , 95 % confidence interval [ CI ] = 4.4-14 .3 ; for amoxicillin administration , RR = 4.7 , 95 % CI = 2.4-8 .7 ) .
RESULTS	Neonates clinically judged to be `` extremely sick '' by the referring TBA were at greatest risk of death ( RR = 8.61 , 95 % CI = 4.0-18 .5 ) .
CONCLUSIONS	The strategy of administering a first dose of antibiotics and referring based solely on the clinical evaluation of a TBA is feasible and could be effective in reducing neonatal mortality in remote rural settings .

###25444793
BACKGROUND	Two major antigenically heterogenous norovirus genogroups ( GI and GII ) commonly infect humans and are the leading cause of foodborne , viral gastrointestinal infections in adults .
METHODS	We assessed B cell responses in participants in a double-blind , placebo-controlled , dose-escalation phase 1 study of the safety and immunogenicity of an intramuscular bivalent norovirus virus-like particle ( VLP ) vaccine .
METHODS	The vaccine contained a GI .1 VLP ( Norwalk ) and a consensus GII .4 VLP , representing the two major genotypes that cause human disease , and was administered on days 0 and 28 to healthy adults aged 18-49 years .
METHODS	Four separate cohorts received increasing doses of 5 g , 15 g , 50 g , and 150 g of each VLP adjuvanted in monophosphoryl lipid A and alum .
METHODS	PBMCs were analyzed for B cell activation and mucosal homing markers ( flow cytometry ) and VLP-specific and total IgG and IgA Ab-secreting cells ( ASCs ) ; and serum titers of VLP-specific IgG , IgA , and Pan-Ig were determined .
RESULTS	The vaccine elicited CD27 + CD38 + plasmablasts and high frequencies of ASCs specific for both VLP antigens in the peripheral blood at 7 days after the first dose .
RESULTS	The plasmablasts exhibited a mucosal-homing phenotype and included a high proportion of IgA ASCs .
RESULTS	Serum antibodies increased as early as 7 days after the first immunization .
CONCLUSIONS	The data suggest that a single dose of the IM bivalent norovirus vaccine is effective in activating pre-existing B cell memory .
CONCLUSIONS	The rapid B cell response and the mucosal homing phenotype of induced ASCs are consistent with anamnestic responses in subjects primed by prior oral norovirus infection .
CONCLUSIONS	This study is registered at ClinicalTrials.gov Identifier NCT01609257 .

###24675102
BACKGROUND	The study aimed to compare the efficacy and safety of nebulized steroid ( NS ) with systemic corticosteroids ( SC ) and to determine optimal NS dose in the treatment of patients with COPD exacerbations requiring hospitalization .
METHODS	The study was a randomized , parallel design trial .
METHODS	Eligible patients ( n = 86 ) were randomly allocated to 1 of the 3 treatment groups : parenteral corticosteroid ( PS ) ( n = 33 ) , 4 mg ( NB ) ( n = 27 ) , or 8 mg NB ( n = 26 ) .
METHODS	Partial pressure of arterial oxygen ( PaO2 ) , carbon dioxide ( PaCO2 ) , pH , and oxygen saturation ( SaO2 ) were evaluated at baseline , 24 h , 48 h , and discharge .
METHODS	Airway obstruction ( forced vital capacity [ FVC ] and forced expiratory volume 1 s [ FEV1 ] ) was evaluated at admission and discharge .
RESULTS	There were no significant differences between the groups for all parameters at all time periods , except for higher FEV1 value in the 8-mg NB group at baseline .
RESULTS	In groups , significant differences were determined for FVC , FEV1 , PaO2 , and SaO2 ( p < 0.001 ) , but not for PaCO2 and pH , in comparison to their baseline values .
RESULTS	As adverse events , hyperglycemia and oral moniliasis were observed in the PS group ( n = 4 ) and in the NB groups ( n = 5 ) , respectively , and treatment change was required in 9 patients ( 2 patients in the PS group and 7 patients in the NB groups ) ( p = 0.57 ) .
CONCLUSIONS	Nebulized budesonide may be used as an alternative to SC because of its equal effectiveness and lesser systemic adverse effects .
CONCLUSIONS	The choice of optimal dosage needs to be evaluated carefully because adverse effect and dropout rates varied according to dosage .
CONCLUSIONS	However , there is a need for further studies including more severe cases and evaluating long-term outcomes or relapses comparing the 3 arms .

###25517706
BACKGROUND	Placebo-controlled trials indicate that cytisine , a partial agonist that binds the nicotinic acetylcholine receptor and is used for smoking cessation , almost doubles the chances of quitting at 6 months .
BACKGROUND	We investigated whether cytisine was at least as effective as nicotine-replacement therapy in helping smokers to quit .
METHODS	We conducted a pragmatic , open-label , noninferiority trial in New Zealand in which 1310 adult daily smokers who were motivated to quit and called the national quitline were randomly assigned in a 1:1 ratio to receive cytisine for 25 days or nicotine-replacement therapy for 8 weeks .
METHODS	Cytisine was provided by mail , free of charge , and nicotine-replacement therapy was provided through vouchers for low-cost patches along with gum or lozenges .
METHODS	Low-intensity , telephone-delivered behavioral support was provided to both groups through the quitline .
METHODS	The primary outcome was self-reported continuous abstinence at 1 month .
RESULTS	At 1 month , continuous abstinence from smoking was reported for 40 % of participants receiving cytisine ( 264 of 655 ) and 31 % of participants receiving nicotine-replacement therapy ( 203 of 655 ) , for a difference of 9.3 percentage points ( 95 % confidence interval , 4.2 to 14.5 ) .
RESULTS	The effectiveness of cytisine for continuous abstinence was superior to that of nicotine-replacement therapy at 1 week , 2 months , and 6 months .
RESULTS	In a prespecified subgroup analysis of the primary outcome , cytisine was superior to nicotine-replacement therapy among women and noninferior among men .
RESULTS	Self-reported adverse events over 6 months occurred more frequently in the cytisine group ( 288 events among 204 participants ) than in the group receiving nicotine-replacement therapy ( 174 events among 134 participants ) ; adverse events were primarily nausea and vomiting and sleep disorders .
CONCLUSIONS	When combined with brief behavioral support , cytisine was found to be superior to nicotine-replacement therapy in helping smokers quit smoking , but it was associated with a higher frequency of self-reported adverse events .
CONCLUSIONS	( Funded by the Health Research Council of New Zealand ; Australian New Zealand Clinical Trials Registry number , ACTRN12610000590066 . )

###25381721
BACKGROUND	Chronic hepatitis B ( CHB ) can progress to cirrhosis , hepatocellular carcinoma ( HCC ) and ultimately liver-related death .
BACKGROUND	Although oral antiviral therapy for patients with CHB reduces the risk of such complications , once cirrhosis is established , the benefits of antiviral therapy are not robustly demonstrated .
BACKGROUND	According to traditional Chinese medicine ( TCM ) , some Chinese herbal medicines promote blood circulation and soften hard masses , and therefore they may block and reverse hepatic fibrosis .
BACKGROUND	The aim of this study is to evaluate the effects of TCM tablets of the compound biejia ruangan ( RGT ) administered for fibrosis , and entecavir ( ETV ) , on the development of HCC in patients with CHB or hepatitis B virus ( HBV ) - related compensated cirrhosis .
METHODS	This multicenter , centrally randomized , double-blind , placebo-controlled , parallel-group study is planned to complete within 5 years .
METHODS	For the study , 1,000 with CHB or HBV-related compensated cirrhosis are randomly assigned in a 1:1 ratio to a treatment group ( 0.5 mg ETV once daily ; 2 g RGT three times daily ) or a control group ( 0.5 mg ETV once daily ; 2 g RGT dummy agent three times daily ) .
METHODS	The primary end points are the development of HCC and liver-related death .
METHODS	Secondary end points include disease progression and overall survival .
CONCLUSIONS	Although antiviral therapy can achieve sustained suppression of HBV replication , thereby preventing cirrhosis , patients with CHB treated with nucleos ( t ) ide analogs ( NUCs ) retain a higher risk for HCC compared with patients with inactive disease .
CONCLUSIONS	Although previous clinical trials with RGT have confirmed the efficacy of blocking and reversing hepatic fibrosis in patients with CHB or compensated cirrhosis , the long-term risk for HCC or disease progression in these patients treated with combination of RGT and NUCs compared with NUCs alone is unclear .
CONCLUSIONS	Therefore , it is necessary to investigate the effects of the RGT blockade and reversal of hepatic fibrosis on the development of HCC in patients with CHB or HBV-related compensated cirrhosis in large , prospective , multicenter , double-blind , randomized , controlled trials in China .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01965418 .
BACKGROUND	Date registered : 17 October 2013 .

###24325834
BACKGROUND	Pain is among the most cited negative effects of orthodontic treatment .
BACKGROUND	Non-steroidal anti-inflammatory drugs seem to be an effective option for minimizing this but can have adverse effects on tooth movement owing to their ability to block prostaglandin synthesis .
BACKGROUND	Acetaminophen has been suggested as the analgesic of choice during orthodontic treatment as it showed no effect on orthodontic tooth movement in previous animal studies .
BACKGROUND	The purpose of this study was to compare the effects of ibuprofen and acetaminophen on the prostaglandin E2 ( PGE2 ) levels of the gingival crevicular fluid ( GCF ) during orthodontic tooth movement in human subjects .
METHODS	A total of 42 patients ( mean age 184.5 years ) were randomly divided into three equal groups : ibuprofen , acetaminophen , and control groups .
METHODS	Maxillary canines were distalized with 150 g of force delivered by NiTi coil springs .
METHODS	GCF samples were obtained before ( baseline ) and after spring activation at 24 , 48 , and 168 h.
METHODS	The PGE2 content of the GCF was determined using enzyme-linked immunosorbent assay .
RESULTS	PGE2 levels in all groups increased significantly by 24 and 48 h of force application and decreased to baseline levels by 168 h. No significant difference was found between the acetaminophen and control groups at any time point .
RESULTS	There was a significant decrease in PGE2 levels in the ibuprofen group at 24 and 48 h when compared to the other two groups .
CONCLUSIONS	Acetaminophen showed no significant effect on prostaglandin synthesis and may be the safe choice compared to ibuprofen for relieving pain associated with orthodontic tooth movement .

###24936090
OBJECTIVE	To examine the clinical and cost-effectiveness of brief advice for excessive alcohol consumption among people who attend sexual health clinics .
METHODS	Two-arm , parallel group , assessor blind , pragmatic , randomised controlled trial .
METHODS	802 people aged 19 years or over who attended one of three sexual health clinics and were drinking excessively were randomised to either brief advice or control treatment .
METHODS	Brief advice consisted of feedback on alcohol and health , written information and an offer of an appointment with an Alcohol Health Worker .
METHODS	Control participants received a leaflet on health and lifestyle .
METHODS	The primary outcome was mean weekly alcohol consumption during the previous 90 days measured 6 months after randomisation .
METHODS	The main secondary outcome was unprotected sex during this period .
RESULTS	Among the 402 randomised to brief advice , 397 ( 99 % ) received it .
RESULTS	The adjusted mean difference in alcohol consumption at 6 months was -2.33 units per week ( 95 % CI -4.69 to 0.03 , p = 0.053 ) among those in the active compared to the control arm of the trial .
RESULTS	Unprotected sex was reported by 154 ( 53 % ) of those who received brief advice , and 178 ( 59 % ) controls ( adjusted OR = 0.89 , 95 % CI 0.63 to 1.25 , p = 0.496 ) .
RESULTS	There were no significant differences in costs between study groups at 6 months .
CONCLUSIONS	Introduction of universal screening and brief advice for excessive alcohol use among people attending sexual health clinics does not result in clinically important reductions in alcohol consumption or provide a cost-effective use of resources .
BACKGROUND	Current Controlled Trials ISRCTN 99963322 .

###24781895
OBJECTIVE	Dietary nitrate supplementation with beetroot juice ( BR ) has received widespread attention as an ergogenic aid .
OBJECTIVE	However , recent evidence in well-trained cyclists has not consistently reported improved cycling economy or performance .
OBJECTIVE	The present study examined the effects of acute and chronic BR supplementation on VO2 during submaximal running and 1500-m time trial ( TT ) performance of elite distance runners .
METHODS	Eight male 1500-m runners ( VO2peak , 80 5 mLkgmin ; 1500-m personal best , 3:56 9 s ) participated in this study .
METHODS	In a randomized , double-blind , crossover design , subjects supplemented with BR or a nitrate-free BR placebo ( PL ) for 8 d separated by at least 1 wk .
METHODS	On days 1 ( acute ) and 8 ( chronic ) , subjects ingested 210 mL of BR ( 19.5-mmol nitrate ) or PL and completed a submaximal treadmill run and 1500-m TT on an indoor 200-m track .
RESULTS	Plasma nitrate increased from 37 15 to 615 151 M ( acute ) and 870 259 M ( chronic ) after BR supplementation .
RESULTS	There were no VO2 differences between conditions at 50 % , 65 % , and 80 % VO2peak ( acute PL , 4194 90 mLmin ; chronic PL , 4216 95 mLmin ; acute BR , 4192 113 mLmin ; chronic BR , 4299 92 mLmin ) .
RESULTS	The 1500-m TT was unaffected by acute or chronic BR supplementation ( acute PL , 4:10.4 min : s 2.5 s ; chronic PL , 4:11.4 min : s 2.7 s ; acute BR , 4:10.7 min : s 1.5 s ; chronic BR , 4:10.5 min : s 2.2 s ) .
RESULTS	However , two subjects improved their TT performance after acute ( 5.8 and 5.0 s ) and chronic BR supplementation ( 7.0 and 0.5 s ) .
CONCLUSIONS	Acute and chronic BR supplementation did not reduce running VO2 or improve 1500-m TT performance of a group of elite distance runners , but two responders to BR were identified .

###25883244
OBJECTIVE	To evaluate the effectiveness of transcranial direct current stimulation alone and in combination with cognitive behavioural management in patients with non-specific chronic low back pain .
METHODS	Double blind parallel group randomised controlled trial with six months ' follow-up conducted May 2011-March 2013 .
METHODS	Participants , physiotherapists , assessors , and analyses were blinded to group allocation .
METHODS	Interdisciplinary chronic pain centre .
METHODS	135 participants with non-specific chronic low back pain > 12 weeks were recruited from 225 patients assessed for eligibility .
METHODS	Participants were randomised to receive anodal ( 20 minutes to motor cortex at 2 mA ) or sham transcranial direct current stimulation ( identical electrode position , stimulator switched off after 30 seconds ) for five consecutive days immediately before cognitive behavioural management ( four week multidisciplinary programme of 80 hours ) .
METHODS	Two primary outcome measures of pain intensity ( 0-100 visual analogue scale ) and disability ( Oswestry disability index ) were evaluated at two primary endpoints after stimulation and after cognitive behavioural management .
RESULTS	Analyses of covariance with baseline values ( pain or disability ) as covariates showed that transcranial direct current stimulation was ineffective for the reduction of pain ( difference between groups on visual analogue scale 1 mm ( 99 % confidence interval -8.69 mm to 6.3 mm ; P = 0.68 ) ) and disability ( difference between groups 1 point ( -1.73 to 1.98 ; P = 0.86 ) ) and did not influence the outcome of cognitive behavioural management ( difference between group 3 mm ( -10.32 mm to 6.73 mm ) ; P = 0.58 ; difference between groups on Oswestry disability index 0 point ( -2.45 to 2.62 ) ; P = 0.92 ) .
RESULTS	The stimulation was well tolerated with minimal transitory side effects .
CONCLUSIONS	This results of this trial on the effectiveness of transcranial direct current stimulation for the reduction of pain and disability do not support its clinical use for managing non-specific chronic low back pain.Trial registration Current controlled trials ISRCTN89874874 .

###24220251
OBJECTIVE	The purposes of this study were to establish the physiological interpretation of the shape parameter of the dynamic contrast-enhanced ultrasound ( DCE-US ) lognormal perfusion model and to evaluate the clinical significance of the parameter in a sample of patients undergoing antiangiogenic therapy for metastatic renal cell carcinoma ( mRCC ) .
METHODS	The physiological interpretation of the lognormal shape parameter was explored using computer simulations of disruption-replenishment in fractal models of the microcirculation generated by a piecewise iterative algorithm in MATLAB .
METHODS	Architectural variety was accomplished by introducing random perturbations to the diameter , length , and branching angles to the growing vascular tree .
METHODS	The shape parameter was extracted from the time-intensity curves and compared with the transit time distributions calculated directly from the simulations .
METHODS	Dynamic contrast-enhanced ultrasound data were obtained from 31 consenting patients with mRCC being treated with antiangiogenic therapy .
METHODS	Lognormal parameters related to the blood volume , mean flow speed , and vascular morphology/heterogeneity extracted before , during , and after therapy were correlated with progression-free survival ( PFS ) .
METHODS	Cox proportional hazard ratios were calculated alongside receiver operator characteristics for different combinations of the vascular parameters to determine their ability to distinguish patients who would progress early ( less than the median PFS ) versus late ( greater than the median PFS ) .
RESULTS	The lognormal shape parameter correlated strongly to the width of the transit time distribution calculated directly from the simulations , and by extension , to the morphology/heterogeneity of the microvascular network ( Spearman r = 0.80 , P < 0.001 , n = 28 ) .
RESULTS	Shorter time to progression was predicted by higher baseline heterogeneity ( P = 0.003 ) and a reduction in tumor blood volume less than 43 % ( P = 0.002 ) after 2 weeks of treatment .
RESULTS	Combining baseline parameters with changes that occur shortly after starting treatment increased the sensitivity and specificity of DCE-US to identify which patients would progress/resist therapy early versus late compared with when the vascular parameters were considered in isolation .
CONCLUSIONS	The DCE-US shape parameter from the lognormal perfusion model is representative of microvascular morphology/heterogeneity and may be used to noninvasively characterize the vascular architecture of cancer lesions .
CONCLUSIONS	A more abnormal flow distribution at baseline predicts for poorer outcome for patients treated with antiangiogenic therapy for metastatic renal cell cancer .
CONCLUSIONS	Combining pretreatment and on-treatment measurements of vascularity can improve the performance of DCE-US to predict which patients will progress earlier versus later when on antiangiogenic therapy for mRCC .

###25375664
BACKGROUND	There is considerable interindividual variability in pulmonary artery pressure among high-altitude ( HA ) dwellers , but the underlying mechanism is not known .
BACKGROUND	At low altitude , a patent foramen ovale ( PFO ) is present in about 25 % of the general population .
BACKGROUND	Its prevalence is increased in clinical conditions associated with pulmonary hypertension and arterial hypoxemia , and it is thought to aggravate these problems .
METHODS	We searched for a PFO ( transesophageal echocardiography ) in healthy HA dwellers ( n = 22 ) and patients with chronic mountain sickness ( n = 35 ) at 3,600 m above sea level and studied its effects ( transthoracic echocardiography ) on right ventricular ( RV ) function , pulmonary artery pressure , and vascular resistance at rest and during mild exercise ( 50 W ) , an intervention designed to further increase pulmonary artery pressure .
RESULTS	The prevalence of PFO ( 32 % ) was similar to that reported in low-altitude populations and was not different in participants with and without chronic mountain sickness .
RESULTS	Its presence was associated with RV enlargement at rest and an exaggerated increase in right-ventricular-to-right-atrial pressure gradient ( 25 7 mm Hg vs 15 9 mm Hg , P < .001 ) and a blunted increase in fractional area change of the right ventricle ( 3 % [ -1 % , 5 % ] vs 7 % [ 3 % , 16 % ] , P = .008 ) during mild exercise .
CONCLUSIONS	These findings show , we believe for the first time , that although the prevalence of PFO is not increased in HA dwellers , its presence appears to facilitate pulmonary vasoconstriction and RV dysfunction during a mild physical effort frequently associated with daily activity .
BACKGROUND	ClinicalTrials.gov ; No. : NCT01182792 ; URL : www.clinicaltrials.gov .

###24326792
OBJECTIVE	In most ocular procedures , a central position of the eye is necessary .
OBJECTIVE	This can be achieved using a deep plane of anaesthesia , locoregional blocks or with neuromuscular blocking agents .
OBJECTIVE	The aim of this study was to evaluate the influence of atracurium on cardiovascular parameters , and on recovery quality and duration in horses .
METHODS	Thirty-four warmblood horses undergoing in total 50 vitrectomies were divided into two groups .
METHODS	Premedication , induction and maintenance were identical in all patients .
METHODS	After 20 minutes , horses of group A received atracurium ( 0.1 mg/kg ) while in the control group ( group K ) the depth of anaesthesia was adapted to keep the bulbus in a central position .
METHODS	Dobutamine and fluids were administered to maintain the mean arterial blood pressure ( MAP ) above 70 mmHg .
METHODS	Cardiac output ( CO ) , heart rate ( HR ) , MAP , respiratory rate , end-expiratory isoflurane concentration ( ETIso ) and dobutamine requirements were determined .
METHODS	Position and movement of the globe during the surgical procedure were scored .
METHODS	Time and quality of the recovery period was scored .
RESULTS	Horses of group K required significantly higher concentrations of isoflurane ( group A : 1.08 0.1 % ; group K : 1.34 0.2 % ) and had an overall lower MAP ( group A : 88.4 10.3 mmHg ; group K : 76.6 11.6 mmHg ) and CO ( group A : 36.9 11.7 l/min ; group K : 28.5 7.2 l/min ) but needed significantly more dobutamine ( group A : 0.37 0.17 g/kg/min ; group K : 0.99 0.46 g/kg/min ) compared to group A. Complete relaxation occurred 9.5 2.5 minutes after atracurium bolus and lasted for 25 7.1 minutes .
RESULTS	The score of the bulbus position and movement was significantly lower in group A , resulting in a better quality for the surgical procedure .
RESULTS	In group A , the recovery time to standing was significantly shorter ( group A : 18.1 5.4 min ; group K : 31.5 7.1 min ) , with no difference in quality .
CONCLUSIONS	The use of atracurium resulted in a better cardiovascular condition , probably because of the isoflurane-sparing effect .
CONCLUSIONS	The recovery time was shorter in these horses without negative effects on recovery quality .
CONCLUSIONS	No signs of residual atracurium effects were detected .

###25807670
BACKGROUND	The present study was aimed at determining the role warm saline rinse in the prevention of alveolar osteitis following dental extractions .
METHODS	Apparently patients aged 16 and above who were referred to the Oral Surgery Clinic of our institution , with an indication for non-surgical extraction of pathologic teeth were prospectively and uniformly randomized into warm saline group and control .
METHODS	The experimental group ( n = 80 ) were instructed to gargle 6 times daily with warm saline and no such instructions were given to the second group ( n = 80 ) to serve as controls .
METHODS	Information on demographic , indications for extraction , and development of alveolar osteitis were obtained and analyzed .
METHODS	Comparative statistics were done using Pearson 's chi square or Fisher 's exact test as appropriate .
METHODS	A p value of less than 0.05 was considered significant .
RESULTS	The demographic and other baseline parameters such as indications for extractions were comparable among the study groups ( p > 0.05 ) .
RESULTS	The overall prevalence of alveolar osteitis was 13.7 % .
RESULTS	There was a statistical significant difference between the study groups with respect to development of alveolar osteitis ( X2 = 15.00 , df = 1 , p = 0.001 ) .
RESULTS	The risk of development of alveolar osteitis was 4 times higher in the control group ( OR = 4.33 , P = 0.001 ) .
CONCLUSIONS	Warm saline mouth rinse instruction is beneficial in the prevention of development of alveolar osteitis after dental extractions .

###25542520
OBJECTIVE	To evaluate the growth of geographic atrophy ( GA ) during anti-vascular endothelial growth factor ( VEGF ) therapy .
METHODS	Cohort within a clinical trial .
METHODS	Patients included in the Comparison of Age-related Macular Degeneration Treatments Trials ( CATT ) .
METHODS	Participants were randomly assigned to injections of ranibizumab or bevacizumab and to a 2-year dosing regimen of monthly or pro re nata ( PRN ) or to monthly for 1 year and PRN the following year .
METHODS	Digital color photographs and fluorescein angiograms at baseline and 1 and 2 years were evaluated for GA , and the total area of GA was measured by 2 graders masked to treatment ; differences were adjudicated .
METHODS	Multivariate linear mixed models of the annual change in the square root of the area included baseline demographic , treatment , and ocular characteristics on imaging as candidate risk factors .
METHODS	Geographic atrophy growth rate .
RESULTS	Among 1185 participants , 86 ( 7.3 % ) had GA at baseline , 120 ( 10.1 % ) developed GA during year 1 , and 36 ( 3.0 % ) developed GA during year 2 .
RESULTS	Among 194 eyes evaluable for growth , the rate was 0.43 mm/yr ( standard error [ SE ] , 0.03 mm/year ) .
RESULTS	In multivariate analysis , the growth rate was 0.37 mm/year in eyes receiving bevacizumab and 0.49 mm/year in eyes receiving ranibizumab ( difference , 0.11 mm/yr ; 95 % confidence interval [ CI ] , 0.01-0 .22 ; P = 0.03 ) .
RESULTS	Growth rate did not differ between eyes treated monthly and PRN ( P = 0.85 ) .
RESULTS	Eyes with subfoveal choroidal neovascularization ( CNV ) lesions had a lower growth rate than eyes with nonsubfoveal CNV lesions ( difference , 0.12 ; 95 % CI , 0.01-0 .22 ; P = 0.03 ) .
RESULTS	Eyes with GA farther from the fovea had higher growth rates by 0.14 ( 95 % CI , 0.01-27 ) mm/year for every millimeter farther from the fovea .
RESULTS	The growth rate was 0.58 mm/year for eyes with predominantly classic lesions , 0.41 mm/year for eyes with minimally classic lesions , and 0.30 mm/year for eyes with occult only lesions ( P < 0.01 ) .
RESULTS	The growth rate in eyes having a fellow eye with GA was higher by 0.13 mm/year ( 95 % CI , 0.01-0 .24 ; P = 0.03 ) than in eyes without GA in the fellow eye .
RESULTS	Eyes with epiretinal membrane had a higher growth rate than eyes without epiretinal membrane ( difference , 0.16 ; 95 % CI , 0.03-0 .30 ; P = 0.02 ) .
CONCLUSIONS	Geographic atrophy growth depends on several ocular factors .
CONCLUSIONS	Ranibizumab may accelerate GA growth .

###25521843
BACKGROUND	Intravenous ( IV ) acetaminophen may be an effective component of multimodal postoperative pain management .
BACKGROUND	The primary objective of this study was to evaluate the impact of IV acetaminophen on total opioid use in postoperative patients .
BACKGROUND	The secondary objective was to evaluate the effect of IV acetaminophen on hospital length of stay .
METHODS	This retrospective , case-control study evaluated the impact of IV acetaminophen on total opioid use in surgical patients .
METHODS	Patients were included if they received at least one perioperative dose of IV acetaminophen and underwent a surgical knee procedure .
METHODS	Controls were matched and randomly selected based on procedure type , age , and severity of illness .
METHODS	Postoperative opioids were converted into oral morphine equivalents , and overall use was compared between groups .
RESULTS	One hundred patients were enrolled , with 25 patients receiving IV acetaminophen and 75 matched controls .
RESULTS	A total of 135mg versus 112.5 mg oral morphine equivalents were used in the IV acetaminophen group and control group , respectively ( p = 0.987 ) .
RESULTS	There were 45mg/day oral morphine equivalents used in the IV acetaminophen group versus 37.5 mg in the control group ( p = 0.845 ) .
RESULTS	The median hospital length of stay in both groups was 3days ( p = 0.799 ) .
CONCLUSIONS	IV acetaminophen did not significantly decrease postoperative opioid use in patients who underwent surgical knee procedures .
CONCLUSIONS	In addition , there was a nonsignificant trend toward increased opioid use in the IV acetaminophen group .
CONCLUSIONS	There was no significant difference in hospital length of stay between the IV acetaminophen group and the control group .
CONCLUSIONS	These findings require further study in larger patient populations and in other orthopedic procedures that typically require longer hospital stays .

###25338927
OBJECTIVE	To determine if repetitive sphenopalatine ganglion ( SPG ) blocks with 0.5 % bupivacaine delivered through the Tx360 ( ) are superior in reducing pain associated with chronic migraine ( CM ) compared with saline .
BACKGROUND	The SPG is a small concentrated structure of neuronal tissue that resides within the pterygopalatine fossa ( PPF ) in close proximity to the sphenopalatine foramen and is innervated by the maxillary division of the trigeminal nerve .
BACKGROUND	From an anatomical and physiological perspective , SPG blockade may be an effective acute and preventative treatment for CM .
METHODS	This was a double-blind , parallel-arm , placebo-controlled , randomized pilot study using a novel intervention for acute treatment in CM .
METHODS	Up to 41 subjects could be enrolled at 2 headache specialty clinics in the US .
METHODS	Eligible subjects were between 18 and 80 years of age and had a history of CM defined by the second edition of the International Classification of Headache Disorders appendix definition .
METHODS	They were allowed a stable dose of migraine preventive medications that was maintained throughout the study .
METHODS	Following a 28-day baseline period , subjects were randomized by computer-generated lists of 2:1 to receive 0.5 % bupivacaine or saline , respectively .
METHODS	The primary end-point was to compare numeric rating scale scores at pretreatment baseline vs 15 minutes , 30 minutes , and 24 hours postprocedure for all 12 treatments .
METHODS	SPG blockade was accomplished with the Tx360 ( ) , which allows a small flexible soft plastic tube that is advanced below the middle turbinate just past the pterygopalatine fossa into the intranasal space .
METHODS	A 0.3 cc of anesthetic or saline was injected into the mucosa covering the SPG .
METHODS	The procedure is performed similarly in each nostril .
METHODS	The active phase of the study consisted of a series of 12 SPG blocks with 0.3 cc of 0.5 % bupivacaine or saline provided 2 times per week for 6 weeks .
METHODS	Subjects were re-evaluated at 1 and 6 months postfinal procedure .
RESULTS	The final dataset included 38 subjects , 26 in the bupivacaine group and 12 in the saline group .
RESULTS	A repeated measures analysis of variance showed that subjects receiving treatment with bupivacaine experienced a significant reduction in the numeric rating scale scores compared with those receiving saline at baseline ( M = 3.78 vs M = 3.18 , P = .10 ) , 15 minutes ( M = 3.51 vs M = 2.53 , P < .001 ) , 30 minutes ( M = 3.45 vs M = 2.41 , P < .001 ) , and 24 hours after treatment ( M = 4.20 vs M = 2.85 , P < .001 ) , respectively .
RESULTS	Headache Impact Test-6 scores were statistically significantly decreased in subjects receiving treatments with bupivacaine from before treatment to the final treatment ( Mdiff = -4.52 , P = .005 ) , whereas no significant change was seen in the saline group ( Mdiff = -1.50 , P = .13 ) .
CONCLUSIONS	SPG blockade with bupivacaine delivered repetitively for 6 weeks with the Tx360 ( ) device demonstrates promise as an acute treatment of headache in some subjects with CM .
CONCLUSIONS	Statistically significant headache relief is noted at 15 and 30 minutes and sustained at 24 hours for SPG blockade with bupivacaine vs saline .
CONCLUSIONS	The Tx360 ( ) device was simple to use and not associated with any significant or lasting adverse events .
CONCLUSIONS	Further research on sphenopalatine ganglion blockade is warranted .

###25487477
OBJECTIVE	The aim of this study was to investigate the efficacy of a single shot intercostal block for pain control in pediatric patients undergoing the Nuss procedure .
METHODS	A double-blind , randomized , controlled study was performed .
METHODS	Thirty patients received a single shot bilateral intercostal block with levobupivacaine ( L group ) and 30 patients with 0.9 % saline ( S group ) .
METHODS	Standardized baseline analgesia was applied for all patients .
METHODS	Morphine consumption , pain scores , respiratory depression , nausea and vomiting , and urinary retention were recorded every 3h for 48h after surgery .
RESULTS	The loading dose of morphine was lower ( p < 0.00001 ) in the L group .
RESULTS	There were significantly lower morphine doses up to 6h after surgery and VAS scores up to 3h after surgery in the L group ( p < 0.001 and p = 0.0003 , respectively ) .
RESULTS	The incidence of nausea and vomiting was lower in the L group ( < 0.00001 ) .
RESULTS	The incidence of urinary retention was lower in the L group ( p = 0.019 ) .
CONCLUSIONS	A single shot IB is an effective additional treatment for pediatric patients undergoing the Nuss procedure and results in the reduced consumption of morphine , less postoperative pain , and fewer opioid-related adverse effects .

###24387624
OBJECTIVE	To evaluate a slower ( compared with a standard ) infusion rate of the loading dose of magnesium sulphate for preterm fetal neuroprotection as a strategy to reduce maternal adverse effects .
METHODS	Randomised controlled trial .
METHODS	South Australian maternity hospital .
METHODS	Fifty-one women at < 30 weeks of gestation , where birth was planned or expected within 24 hours .
METHODS	Women received a loading infusion of 4 g of magnesium sulphate over either 60 or 20 minutes ( followed by maintenance of 1 g/hour until birth , or for up to 24 hours ) .
METHODS	Any maternal adverse effects associated with the infusion .
RESULTS	Overall , 71 % of women experienced adverse effects during the first hour of their infusion ; the difference between groups was not significant [ 15/25 ( 60 % ) 60-minute loading ; 21/26 ( 81 % ) 20-minute loading ; risk ratio ( RR ) 0.74 ; 95 % confidence interval ( 95 % CI ) 0.51-1 .08 ] .
RESULTS	Although no serious maternal complications occurred , adverse effects led to three women ceasing the loading treatment ( 1/25 in the 60-minute loading group ; 2/26 in the 20-minute loading group ; RR 0.52 ; 95 % CI 0.05-5 .38 ) .
RESULTS	Women in the 60-minute loading group experienced significantly less warmth and flushing at 20 minutes into the infusion ( 7/25 in the 60-minute loading group ; 15/26 in the 20-minute loading group ; RR 0.49 ; 95 % CI 0.24-0 .99 ) .
RESULTS	No other differences between groups for maternally reported and clinical adverse effects were shown .
CONCLUSIONS	A slower rate of administering the loading dose of magnesium sulphate did not reduce the occurrence of maternal adverse effects overall .
CONCLUSIONS	Flushing and warmth at 20 minutes into the infusion was reduced with a slower infusion .

###25707081
OBJECTIVE	To determine whether sugar-free gum can provide remineralization and caries control of active enamel caries lesions compared to baseline ( before gum chewing ) and to a no-gum group , following daily chewing for 12 weeks by school children ; to determine whether chewing frequency can affect the extent of remineralization .
METHODS	A pragmatic cluster-randomized controlled clinical trial with schools as the unit of randomization was employed .
METHODS	Three schools in Chengdu , PR China comprised the clusters .
METHODS	The study was approved by the Internal Review Board of Sichuan University .
METHODS	177 school children , 8-13 years old , with at least one visible white-spot lesion were enrolled in the study .
METHODS	Each of the three clusters was randomly assigned to one of three groups : ( 1 ) no gum ; ( 2 ) chew 2 pieces of sugar-free gum for 20 minutes , 3x per day ; ( 3 ) chew 2 pieces of sugar-free gum for 12 minutes , 5x per day .
METHODS	White-spot lesions were examined by quantitative light-induced fluorescence ( QLF ) at baseline and after 4 , 8 , and 12 weeks of treatment .
RESULTS	155 subjects completed the study .
RESULTS	Of them , the mean values of fluorescence loss at baseline were 9.52 , 9.83 and 9.17 for no-gum group , 3x per day group and 5x per day group , respectively .
RESULTS	For the area , the mean values at baseline were 2.52 , 2.61 and 2.57 mm2 for no-gum group , 3x per day group and 5x per day group , respectively .
RESULTS	For AQ , the mean values at baseline were -27.91 , -28.29 and -29.67 for no-gum group , 3x per day group and 5x per day group , respectively .
RESULTS	To adjust for differences in groups at baseline , ANCOVA was used .
RESULTS	After 12-weeks , for all QLF metrics , the absolute values of 5x per day group were the lowest and the no gum group was the highest ; the differences among three groups were statistically significant ( P < 0.05 ) .
RESULTS	For AQ , which was accepted as the most useful metrics of QLF system , the adjusted mean values at 12 weeks were -26.35 , -19.81 and -17.58 for no-gum group , 3x per day group and 5x per day group , respectively .
RESULTS	There were significant differences between groups .

###25046539
BACKGROUND	The primary goal of fluid therapy is to maintain fluid homeostasis .
BACKGROUND	Commonly used isotonic crystalloids are only marginally effective and contribute to fluid excess syndrome .
BACKGROUND	In patients with decreased cardiovascular reserve , fluid therapy alone is not sufficient to maintain end-organ perfusion .
BACKGROUND	Therefore , inotropes or vasoactive drugs are used to supplement fluid infusion .
BACKGROUND	Recent animal data suggest that coinfusion of adrenergic agents modulate the distribution of fluid between the vascular and extravascular/interstitial compartments after a fluid bolus .
BACKGROUND	We sought to determine if this effect would translate in humans by coadministering a - adrenergic agonist with fluid .
METHODS	Nine healthy volunteers ( aged 21-50 years ) were randomly paired and received either a continuous isoproterenol infusion ( ISO : 0.05 g/kg per minute ) or 0.9 % saline ( control [ CON ] ) 30min prior to a 25 mL/kg 0.9 % NaCl fluid bolus .
METHODS	Hemodynamics , ventricular volume and function , and microcirculatory determinants ( capillary filtration coefficient and oncotic pressure ) were measured .
METHODS	Vascular and extravascular volume and fluid balance were determined .
RESULTS	Compared with CON , ISO significantly increased heart rate ( CON : 64.2 4.1 beats/min vs. ISO : 97.4 5.7 beats/min ) and cardiac output ( CON : 4.4 0.7 L/min vs. ISO : 10.2 0.9 ) before fluid bolus .
RESULTS	Isoproterenol significantly increased urinary output ( ISO : 10.86 1.95 vs. control : 6.53 1.45 mL/kg ) and reduced extravascular volume ( 7.98 2.0 vs. 14.15 1.1 mL/kg ) .
RESULTS	Isoproterenol prevented an increase in capillary filtration coefficient ( 1.74 0.4 vs. 3.21 0.4 mL/min per mmHg 10 ) .
CONCLUSIONS	Isoproterenol , a nonselective - adrenergic agonist , augments vascular volume expansion and eliminates extravascular volume via enhanced diuresis , which may in part be due to enhanced endothelial barrier function .

###24815831
OBJECTIVE	To assess the need for surgical treatment in patients with acute abdominal pain in a prospective randomized study .
METHODS	Initially 203 patients with acute abdominal pain were randomized to the routine abdominal computed tomography CT ( rCT , n = 118 ) , or selective abdominal CT group ( sCT , n = 85 ) over a period of 16 months .
METHODS	Ninety-three of the randomized patients ( 45.8 % ) underwent the study design and were reached for follow-up at three months .
RESULTS	Diagnostic accuracy improved significantly in the rCT group ( p < 0.001 ) .
RESULTS	The surgeon 's assessment of the need for surgery changed more often in the rCT group than in the sCT group ( 78.7 % vs. 46.9 % , p = 0.002 ) .
RESULTS	The confidence to treat operatively increased significantly in the rCT vs. the sCT group ( 65.6 % vs. 40.6 % , p = 0.028 ) .
RESULTS	The rCT was the only independent parameter for the change of the assessment of surgery .
CONCLUSIONS	Routine CT allows for more confidence in decision making for the surgical treatment of patients with acute abdominal pain .

###24507484
BACKGROUND	Hand-held NB-UVB units are lightweight devices that may overcome the need to treat vitiligo in hospital-based phototherapy cabinets , allowing early treatment at home that may enhance the likelihood of successful repigmentation .
BACKGROUND	The pilot Hi-Light trial examined the feasibility of conducting a large multi-centre randomised controlled trial ( RCT ) on the use of such devices by exploring recruitment , adherence , acceptability , and patient education .
METHODS	This was a feasibility , double-blind , multi-centre , parallel group randomised placebo-controlled trial of hand-held NB-UVB phototherapy for the treatment of vitiligo at home .
METHODS	The overall duration of the trial was seven months ; three months recruitment and four months treatment .
METHODS	Participants were randomly allocated to active or placebo groups ( 2:1 ratio ) .
METHODS	The primary outcome measure was the proportion of eligible participants who were willing to be randomised .
METHODS	The secondary outcomes included proportion of participants expressing interest in the trial and fulfilling eligibility criteria , withdrawal rates and missing data , proportion of participants adhering to and satisfied with the treatment , and incidence of NB-UVB short-term adverse events .
RESULTS	Eighty-three percent ( 45/54 ) of vitiligo patients who expressed interest in the trial were willing to be randomised .
RESULTS	Due to time and financial constraints , only 29/45 potential participants were booked to attend a baseline hospital visit .
RESULTS	All 29 ( 100 % ) potential participants were confirmed as being eligible and were subsequently randomised .
RESULTS	Willingness to participate in the study for General Practice ( family physicians ) surgeries and hospitals were 40 % and 79 % , respectively ; 86 % ( 25/29 ) of patients adhered to the treatment and 65 % ( 7/11 ) of patients in the active group had some degree of repigmentation .
RESULTS	Only one patient in the active group reported erythema grade 3 ( 3 % ) .
RESULTS	Both devices ( Dermfix 1000 NB-UVB and Waldmann NB-UVB 109 ) were acceptable to participants .
CONCLUSIONS	Hand-held NB-UVB devices need evaluation in a large , pragmatic RCT .
CONCLUSIONS	This pilot trial has explored many of the uncertainties that need to be overcome before embarking on a full scale trial , including the development of a comprehensive training package and treatment protocol .
CONCLUSIONS	The study has shown strong willingness of participants to be randomised , very good treatment adherence and repigmentation rates , and provided evidence of feasibility for a definitive trial .
BACKGROUND	NCT01478945 .

###24332259
BACKGROUND	Aerobic fitness is an important predictor of postoperative outcome in major surgery .
BACKGROUND	In this study , we assess the effects of a period of preoperative exercise on aerobic fitness as measured by cardiopulmonary exercise testing ( CPET ) in patients scheduled for abdominal aortic aneurysm ( AAA ) repair .
METHODS	As part of a randomized trial , the first patients recruited in the intervention group were enrolled in a supervised exercise program of six week duration .
METHODS	Treadmill CPET parameters were measured before and after exercise preoperatively for these patients .
METHODS	These parameters were as follows : peak oxygen uptake ( VO2 peak ) , anaerobic threshold ( AT ) , and ventilator equivalents for oxygen and carbon dioxide ( VE/VO2 and VE/VCO2 , respectively ) .
METHODS	Total exercise time and the time at which AT was achieved were also recorded .
METHODS	A comparison between pre - and postexercise parameters was made to detect for a possible improvement in aerobic fitness .
RESULTS	Twenty patients with AAA ( 17 men ; mean age : 74.9 5.9 years ) were included in this study .
RESULTS	Thirty-five percent of patients had a history of ischemic heart disease , 25 % of obstructive airway disease , and 15 % of cerebral vascular events .
RESULTS	Seventy percent were previous smokers , and 15 % were current smokers .
RESULTS	Fifty-five percent of patients were taking aspirin and 75 % were undergoing statin therapy .
RESULTS	The median ( interquartile range ) VO2 peak at baseline was 18.2 ( 15.4-19 .9 ) mL/kg/min , and after exercise was 19.9 ( 17.1-21 .1 ; P = 0.048 ) .
RESULTS	Median AT at baseline was 12.2 ( 10.5-14 .9 ) , and 14.4 ( 12.3-15 .4 ) after exercise ( P = 0.023 ) .
RESULTS	Time of exercise tolerated also improved from a median of 379to 604sec ( P = 0.001 ) .
RESULTS	No significant changes were seen in VE/VO2 , VE/VCO2 , or the time at which AT was achieved .
CONCLUSIONS	This study shows that cardiopulmonary aerobic fitness improves after a period of supervised exercise in patients scheduled for AAA repair .
CONCLUSIONS	This is justification for a randomized trial to assess whether this affects morbidity and mortality after AAA repair .

###24682973
OBJECTIVE	Natalizumab inhibits the migration of systemic immune cells to the CNS and may be beneficial in progressive multiple sclerosis ( MS ) .
OBJECTIVE	The objective of the study was to examine the effects of natalizumab in progressive MS.
METHODS	In an open-label phase 2A study , 24 patients with progressive MS were included to receive natalizumab treatment for 60 weeks .
METHODS	Response to natalizumab was assessed in CSF and MRI studies .
METHODS	The primary endpoint was change in CSF osteopontin , a biomarker of intrathecal inflammation , from baseline to week 60 .
RESULTS	Seventeen patients completed the study .
RESULTS	No new safety issues were encountered .
RESULTS	CSF osteopontin decreased by 65 ng/mL ( 95 % confidence interval 34-96 ng/mL ; p = 0.0004 ) from baseline to week 60 in conjunction with decreases in other CSF biomarkers of inflammation , axonal damage , and demyelination .
RESULTS	Magnetization transfer ratio increased in both cortical gray and normal-appearing white matter and correlated with decreases in CSF neurofilament light chain .
CONCLUSIONS	Natalizumab treatment of progressive MS reduces intrathecal inflammation and tissue damage , supporting a beneficial effect of natalizumab treatment in progressive MS and suggesting that systemic inflammation contributes to the pathogenesis .
CONCLUSIONS	Moreover , the study establishes the feasibility of using CSF biomarkers in proof-of-concept trials , allowing a low number of participants and short study duration .
METHODS	This study provides Class IV evidence that in patients with progressive MS , natalizumab reduces biomarkers of intrathecal inflammation .

###24755214
BACKGROUND	Despite evidence that erythropoietin and intra - and postoperative blood salvage are expensive techniques considered to be non-cost-effective in primary elective total hip and knee arthroplasties in the Netherlands , Dutch medical professionals use them frequently to prevent the need for allogeneic transfusion .
BACKGROUND	To actually change physicians ' practice , a tailored strategy aimed at barriers that hinder physicians in abandoning the use of erythropoietin and perioperative blood salvage was systematically developed .
BACKGROUND	The study aims to examine the effectiveness , feasibility and costs of this tailored de-implementation strategy compared to a control strategy .
METHODS	A cluster randomized controlled trial including an effect , process and economic evaluation will be conducted in a minimum of 20 Dutch hospitals .
METHODS	Randomisation takes place at hospital level .
METHODS	The hospitals in the intervention group will receive a tailored de-implementation strategy that consists of four components : interactive education , feedback in educational outreach visits , electronically sent reports on hospital performance ( all aimed at orthopedic surgeons and anesthesiologists ) , and information letters or emails aimed at other involved professionals within the intervention hospital ( transfusion committee , OR-personnel , pharmacists ) .
METHODS	The hospitals in the control group will receive a control strategy ( i.e. , passive dissemination of available evidence ) .
METHODS	Outcomes will be measured at patient level , using retrospective medical record review .
METHODS	This will be done in all hospitals at baseline and after completion of the intervention period .
METHODS	The primary outcome of the effect evaluation is the percentage of patients undergoing primary elective total hip or knee arthroplasty in which erythropoietin or perioperative blood salvage is applied .
METHODS	The actual exposure to the tailored strategy and users ' experiences will be assessed in the process evaluation .
METHODS	In the economic evaluation , the costs of the tailored strategy and the control strategy in relation to the difference in their effectiveness will be compared .
CONCLUSIONS	This study will show whether a systematically developed tailored strategy is more effective for de-implementation of non-cost-effective blood saving measures than the control strategy .
CONCLUSIONS	This knowledge can be used in national and international initiatives to make healthcare more efficient .
CONCLUSIONS	It also provides more generalized knowledge regarding de-implementation strategies .
BACKGROUND	This trial is registered at the Dutch Trial Register NTR4044 .

###24480619
OBJECTIVE	The first studies comparing covered stents ( CS ) and bare stents ( BS ) to achieve Transjugular Intrahepatic Portosystemic Shunt ( TIPS ) were in favor of CS , but only one randomized study has been performed .
OBJECTIVE	Our aim was to compare the primary patency of TIPS performed with CS and BS .
METHODS	The study was planned as a multicenter , pragmatic ( with centers different in size and experience ) , randomized , single-blinded ( with blinding of patients only ) , parallel group trial .
METHODS	The primary endpoint was TIPS dysfunction defined as either a portocaval gradient 12mmHg , or a stent lumen stenosis 50 % .
METHODS	A transjugular angiography with portosystemic pressure gradient measurement was scheduled every 6months after TIPS insertion .
RESULTS	137 patients were randomized : 66 to receive CS , and 71 BS .
RESULTS	Patients who were found to have a hepato-cellular carcinoma , or whose procedure was cancelled were excluded , giving a sample of 129 patients ( 62 vs. 67 ) .
RESULTS	Median follow-up for CS and BS were 23.6 and 21.8 months , respectively .
RESULTS	Compared to BS , the risk of TIPS dysfunction with CS was 0.60 95 % CI [ 0.38-0 .96 ] , ( p = 0.032 ) .
RESULTS	The 2-year rate of shunt dysfunction was 44.0 % for CS vs. 63.6 % for BS .
RESULTS	Early post TIPS complications ( 22.4 % vs. 34.9 % ) , risk of hepatic encephalopathy ( 0.89 [ 0.53-1 .49 ] ) and 2-year survival ( 70 % vs. 67.5 % ) did not differ in the two groups .
RESULTS	The 2-year cost/patient was 20k [ 15.9-27 .5 ] for CS vs. 23.4 k [ 18-37 ] for BS ( p = 0.52 ) .
CONCLUSIONS	CS provided a significant 39 % reduction in dysfunction compared to BS .
CONCLUSIONS	We did not observe any significant difference with regard to hepatic encephalopathy or death .

###24463223
OBJECTIVE	This study aims to compare the effect of three CPR prompt and feedback devices on quality of chest compressions amongst healthcare providers .
METHODS	A single blinded , randomised controlled trial compared a pressure sensor/metronome device ( CPREzy ) , an accelerometer device ( Phillips Q-CPR ) and simple metronome on the quality of chest compressions on a manikin by trained rescuers .
METHODS	The primary outcome was compression depth .
METHODS	Secondary outcomes were compression rate , proportion of chest compressions with inadequate depth , incomplete release and user satisfaction .
RESULTS	The pressure sensor device improved compression depth ( 37.24-43 .64 mm , p = 0.02 ) , the accelerometer device decreased chest compression depth ( 37.38-33 .19 mm , p = 0.04 ) whilst the metronome had no effect ( 39.88 mm vs. 40.64 mm , p = 0.802 ) .
RESULTS	Compression rate fell with all devices ( pressure sensor device 114.68-98 .84 min ( -1 ) , p = 0.001 , accelerometer 112.04-102 .92 min ( -1 ) , p = 0.072 and metronome 108.24 min ( -1 ) vs. 99.36 min ( -1 ) , p = 0.009 ) .
RESULTS	The pressure sensor feedback device reduced the proportion of compressions with inadequate depth ( 0.52 vs. 0.24 , p = 0.013 ) whilst the accelerometer device and metronome did not have a statistically significant effect .
RESULTS	Incomplete release of compressions was common , but unaffected by the CPR feedback devices .
RESULTS	Users preferred the accelerometer and metronome devices over the pressure sensor device .
RESULTS	A post hoc study showed that de-activating the voice prompt on the accelerometer device prevented the deterioration in compression quality seen in the main study .
CONCLUSIONS	CPR feedback devices vary in their ability to improve performance .
CONCLUSIONS	In this study the pressure sensor device improved compression depth , whilst the accelerometer device reduced it and metronome had no effect .

###25806661
OBJECTIVE	Dialectical behavior therapy ( DBT ) is an empirically supported treatment for suicidal individuals .
OBJECTIVE	However , DBT consists of multiple components , including individual therapy , skills training , telephone coaching , and a therapist consultation team , and little is known about which components are needed to achieve positive outcomes .
OBJECTIVE	To evaluate the importance of the skills training component of DBT by comparing skills training plus case management ( DBT-S ) , DBT individual therapy plus activities group ( DBT-I ) , and standard DBT which includes skills training and individual therapy .
METHODS	We performed a single-blind randomized clinical trial from April 24 , 2004 , through January 26 , 2010 , involving 1 year of treatment and 1 year of follow-up .
METHODS	Participants included 99 women ( mean age , 30.3 years ; 69 [ 71 % ] white ) with borderline personality disorder who had at least 2 suicide attempts and/or nonsuicidal self-injury ( NSSI ) acts in the last 5 years , an NSSI act or suicide attempt in the 8 weeks before screening , and a suicide attempt in the past year .
METHODS	We used an adaptive randomization procedure to assign participants to each condition .
METHODS	Treatment was delivered from June 3 , 2004 , through September 29 , 2008 , in a university-affiliated clinic and community settings by therapists or case managers .
METHODS	Outcomes were evaluated quarterly by blinded assessors .
METHODS	We hypothesized that standard DBT would outperform DBT-S and DBT-I .
METHODS	The study compared standard DBT , DBT-S , and DBT-I .
METHODS	Treatment dose was controlled across conditions , and all treatment providers used the DBT suicide risk assessment and management protocol .
METHODS	Frequency and severity of suicide attempts and NSSI episodes .
RESULTS	All treatment conditions resulted in similar improvements in the frequency and severity of suicide attempts , suicide ideation , use of crisis services due to suicidality , and reasons for living .
RESULTS	Compared with the DBT-I group , interventions that included skills training resulted in greater improvements in the frequency of NSSI acts ( F1 ,85 = 59.1 [ P < .001 ] for standard DBT and F1 ,85 = 56.3 [ P < .001 ] for DBT-S ) and depression ( t399 = 1.8 [ P = .03 ] for standard DBT and t399 = 2.9 [ P = .004 ] for DBT-S ) during the treatment year .
RESULTS	In addition , anxiety significantly improved during the treatment year in standard DBT ( t94 = -3.5 [ P < .001 ] ) and DBT-S ( t94 = -2.6 [ P = .01 ] ) , but not in DBT-I .
RESULTS	Compared with the DBT-I group , the standard DBT group had lower dropout rates from treatment ( 8 patients [ 24 % ] vs 16 patients [ 48 % ] [ P = .04 ] ) , and patients were less likely to use crisis services in follow-up ( ED visits , 1 [ 3 % ] vs 3 [ 13 % ] [ P = .02 ] ; psychiatric hospitalizations , 1 [ 3 % ] vs 3 [ 13 % ] [ P = .03 ] ) .
CONCLUSIONS	A variety of DBT interventions with therapists trained in the DBT suicide risk assessment and management protocol are effective for reducing suicide attempts and NSSI episodes .
CONCLUSIONS	Interventions that include DBT skills training are more effective than DBT without skills training , and standard DBT may be superior in some areas .
BACKGROUND	clinicaltrials.gov Identifier : NCT00183651 .

###24714004
OBJECTIVE	To compare the effectiveness of two dosing regimens of vaginal misoprostol for cervical ripening and induction of labour .
METHODS	Pregnant women with singleton low risk pregnancy at term scheduled for elective induction of labour were randomized to receive either 25 g or 50 g of vaginal misoprostol for pre-labour cervical ripening .
METHODS	All the patients received antenatal care and delivered at the University College Hospital ( UCH ) from January 1 st to May 31 st 2006 .
METHODS	A total of 128 patients were randomized ; 65 patients received 25 g and 63 patients received 50 g of vaginal misoprostol .
RESULTS	Significantly higher number of patients in the 50 g group progressed to active labour as compared with the 25 g group ( 95.2 % versus 84.6 % , P < 0.05 ) .
RESULTS	The need for oxytocin augmentation of labour was higher among the 25 g as compared with 50 g ( 39.7 % versus 16.4 % , P = 0.007 ) .
RESULTS	There was higher proportion of patients in the 50 g group delivering vaginally within 24 hours as compared with the 25 g group ( 98.2 % versus 90.0 % , P = 0.063 ) .
RESULTS	However , the mean interval between the first dose of misoprostol and vaginal delivery was not statistically different in the two groups ( 754 362 minutes and 885 582 minutes , P = 0.152 ) .
RESULTS	The incidence of caesarean section was similar in the two groups ( 7.7 % versus 11 % , P = 0.580 ) .
RESULTS	Labour complications , such as precipitate labour , tachysystole and abnormal fetal heart rate patterns were greater in the 50 g group .
CONCLUSIONS	Twenty-five microgram of misoprostol appears to be as effective as 50 g for pre-induction cervical ripening and labour induction .
CONCLUSIONS	Though 50 g of vaginal misoprostol resulted in relatively faster delivery and less need for oxytocin augmentation , it was associated with more labour complications as compared with 25 g of misoprostol .

###25226857
OBJECTIVE	To determine whether day 3 FSH and E2 levels at the upper limits of normal affect live-birth rates and treatment trajectory in a conventional versus `` fast track '' treatment program for IVF .
METHODS	Secondary analysis of two randomized controlled trials , FASTT and FORT-T .
METHODS	Not applicable .
METHODS	Infertile women ages 21-42 years randomized to conventional or accelerated treatment with controlled ovarian hyperstimulation ( COH ) - IUI and/or IVF ( n = 603 patients contributing 2,717 total cycles ) .
METHODS	Patients were stratified according to basal FSH and E2 : FSH < 10 mIU/mL and E2 < 40 pg/mL ( group 1A ) , FSH < 10 mIU/mL and E240 pg/mL ( group 1B ) , FSH , 10-15 mIU/mL and E2 < 40 pg/mL ( group 2A ) , and FSH , 10-15 mIU/mL and E240 pg/mL ( group 2B ) .
METHODS	Number of cancelled cycles , disenrollment for poor response , and cumulative live-birth rates per couple .
RESULTS	Women in groups 2A and 2B were more likely to have cancelled cycles and be disenrolled for poor response .
RESULTS	While no live births occurred in group 2B during COH-IUI ( 0/19 couples , 0/58 cycles ) , IVF still afforded these patients a reasonable chance of success ( 6/18 couples , 6/40 cycles , 33.3 % live-birth rate per couple ) .
RESULTS	The specificity and positive predictive value of basal FSH of 10-15 mIU/mL and E240 pg/mL for no live birth during COH-IUI treatment were both 100 % .
CONCLUSIONS	Women who initiated infertility treatment with FSH of 10-15 mIU/mL and E240 pg/mL on day 3 testing were unlikely to achieve live birth after COH-IUI treatment .

###25527998
BACKGROUND	Stratified medicine aims to improve clinical and cost-effectiveness by identifying moderators of treatment that indicate differential response to treatment .
BACKGROUND	Cognitive behavioural therapy ( CBT ) is often offered as a ` next-step ' for patients who have not responded to antidepressants , but no research has examined moderators of response to CBT in this population .
BACKGROUND	We aimed , therefore , to identify moderators of response to CBT in treatment resistant depression .
METHODS	We used linear regression to test for interactions between treatment effect and 14 putative moderator variables using data from the CoBalT randomised controlled trial .
METHODS	This trial examined the effectiveness of CBT given in addition to usual care ( n = 234 ) compared with usual care alone ( n = 235 ) for primary care patients with treatment resistant depression .
RESULTS	Age was the only variable with evidence for effect modification ( p Value for interaction term = 0.012 ) , with older patients benefiting the most from CBT .
RESULTS	We found no evidence of effect modification by any other demographic , life , illness , personality trait , or cognitive variable ( p0 .2 ) .
CONCLUSIONS	Given the largely null findings , a stratified approach that might limit offering CBT is premature ; CBT should be offered to all individuals where antidepressant medication has failed .

###25842795
OBJECTIVE	To determine the effectiveness of a non-return catheter valve vs. the standard urine bag for prevention of catheter-associated urinary tract infections ( CAUTI ) in critically ill patients .
METHODS	This was a pilot , randomized , stratified , open-label controlled trial ( ClinicalTrials.gov , number NCT01963013 ) .
METHODS	Ninety-six critically illpatients requiring indwelling urinary catheter were assigned with either a non-return catheter valve or the standard urine bag .
METHODS	Symptoms and signs of CAUTI before and after enrollment for all patients were recorded .
METHODS	If CAUTI was suspected , urine for microbiological testing was collected The primary outcome was the incidence density rate of symptomatic CAUTI and bacteriurial presence .
RESULTS	The 96 patients were randomized into two groups .
RESULTS	Baseline patient characteristics were similar in both groups except for the sex distribution .
RESULTS	The incidence rate ratio was 0.71 for symptomatic CAUTI in the non-return catheter valve group ( 95 % CI 0.25-1 .98 , p-value = 0.51 ) .
RESULTS	The crude incidence rate ratio of bacteriuria in the non-return valve group was 0.66 ( 95 % CI 0.3-1 .46 , p-value = 0.31 ) .
RESULTS	The sex-adjusted incidence rate ratio of bacteriuria in the non-return catheter valve group was 0.64 ( 95 % CI 0.29-1 .41 , p-value = 0.27 ) .
CONCLUSIONS	Using a non-return catheter valve might not prevent CA UTI among critically ill patients .

###25232074
BACKGROUND	There is limited Level-I evidence that compares operative and nonoperative treatment of rotator cuff tears .
BACKGROUND	We compared outcomes of patients treated with primary tendon repair with outcomes of those treated with physiotherapy and optional secondary tendon repair if needed .
METHODS	A single-center , pragmatic , randomized controlled study with follow-ups after six months and one , two , and five years was conducted in a secondary-care institution .
METHODS	One hundred and three patients with a rotator cuff tear not exceeding 3 cm were randomized to primary tendon repair ( n = 52 ) or physiotherapy ( n = 51 ) .
METHODS	The primary outcome measure was the Constant score .
METHODS	Secondary outcome measures included the self-report section of the American Shoulder and Elbow Surgeons score ; the physical component summary measure of the Short Form 36 Health Survey ; the measurement of pain , strength , and shoulder motion ; patient satisfaction ; and findings from magnetic resonance imaging and sonography .
METHODS	Analysis was by intention to treat .
RESULTS	The five-year follow-up rate was 98 % .
RESULTS	Twelve of the fifty-one patients in the physiotherapy group were treated with secondary tendon repair .
RESULTS	The results from primary tendon repair were superior to those from physiotherapy plus secondary repair , with between-group mean differences of 5.3 points on the Constant score ( p = 0.05 ) , 9.0 points on the American Shoulder and Elbow Surgeons score ( p < 0.001 ) , 1.1 cm on a 10-cm visual analog scale for pain ( p < 0.001 ) , and 1.0 cm on a 10-cm visual analog scale for patient satisfaction ( p = 0.03 ) .
RESULTS	In 37 % of tears treated with physiotherapy only , there were increasing tear sizes on ultrasound of > 5 mm , over five years , associated with an inferior outcome .
CONCLUSIONS	Although primary repair of small and medium-sized rotator cuff tears was associated with better outcome than physiotherapy treatment , the differences were small and may be below clinical importance .
CONCLUSIONS	In the physiotherapy treatment group , there were increasing tear sizes and inferior outcomes in one-third of patients who did not undergo repair .

###25134285
BACKGROUND	The aim of the present study was to evaluate the efficacy of misoprostol administered sublingually , vaginally or rectally on cervical ripening before hysterescopic surgery in post-menopausal women .
METHODS	Post-menopausal women were randomised to receive either 400 ug of misoprostol , administered sublingually , vaginally or rectally six hours and 12 hours prior to operative hysterescopy .
RESULTS	Patients were randomized to receive receive sublingual ( n = 30 ) , rectal ( n = 30 ) or vaginal ( n = 30 ) misoprostol .
RESULTS	The control group did not receive misoprostol ( n = 30 ) .
RESULTS	The four groups were comparable in terms of preoperative cervical width after misoprostol administration .
RESULTS	The mean cervical widths for control group was 9.0 + / - 1.1 mm and the mean post-treatment cervical widths for the sublingual , vaginal , and rectal groups were 7.1 + / - 1.1 mm , 8.9 + / - 1.3 mm , and 8.6 + / - 1.5 mm , respectively .
RESULTS	The cervical widths of sublingual group were significantly different from control , vaginal ; and rectal groups ( p < 0.001 ) .
CONCLUSIONS	Four hundred micrograms of sublingual misoprostol , 12 and six hours prior to operative hysteroscopy has a significant cervical ripening effect compared with vaginal , rectal , and control groups in post-menopausal women .

###24290597
OBJECTIVE	Calcium ( Ca ) and iron ( Fe ) are essential minerals for normal growth and development .
OBJECTIVE	Although previous studies have shown that Ca inhibits acute Fe absorption , there is no evidence of the possible long - or medium-term effects of Ca supplementation on Fe bioavailability .
OBJECTIVE	The aim of this study was to determine the effect of 34 d of Ca supplementation on heme Fe and non-heme Fe bioavailability in non-pregnant women of ages 33 to 47 y.
METHODS	This was a prospective , randomized , double-blind , placebo-controlled trial .
METHODS	Twenty-six healthy women ( 40 5 y ) were randomly assigned to receive either 600 mg of elemental Ca/d as CaCO3 ( Ca group , n = 13 ) or a placebo ( P group , n = 13 ) for 34 d. Heme Fe and non-heme Fe bioavailability were determined before and after treatment using ( 55 ) Fe and ( 59 ) Fe radioisotopes .
METHODS	A two-factor , repeated-measures analysis of variance was used to assess differences by treatment and timing .
RESULTS	The geometric mean ( range 1 SD ) of heme Fe bioavailability before and after treatment was 16.5 % ( 8.3-32 .8 ) and 26 % ( 15.5-43 .6 ) for the Ca group and 21.8 % ( 13.0-36 .6 ) and 25.1 % ( 16.5-38 .3 ) for the P group .
RESULTS	Non-heme Fe bioavailability before and after treatment was 39.5 % ( 19.9-78 .7 ) and 34.1 % ( 19.1-60 .6 ) for the Ca group , and 44.6 % ( 24.9-79 .7 ) and 39.3 % ( 24.3-63 .4 ) for the P group .
RESULTS	There were no differences in either heme Fe or non-heme Fe bioavailability either at baseline or after treatment .
CONCLUSIONS	The administration of calcium supplements for 34 d does not affect iron bioavailability .
CONCLUSIONS	This trial is registered with Controlled-trials .
CONCLUSIONS	gov , number ISRCTN 89888123 .

###25794213
BACKGROUND	Chronic inguinal neuralgia has been reported after inguinal herniorrhaphy , caesarean section , appendectomy , and trauma to the lower quadrant of the abdomen or inguinal region .
OBJECTIVE	This study was designed to evaluate the efficacy of pulsed radiofrequency in management of chronic inguinal neuralgia .
METHODS	Randomized , double-blind controlled trial .
METHODS	Hospital outpatient setting .
METHODS	Twenty-one patients were allocated into 2 groups .
METHODS	Group 1 received 2 cycles of pulsed radiofrequency ( PRF ) for each nerve root .
METHODS	In Group 2 , after stimulation , we spent the same time to mimic PRF .
METHODS	Both groups received bupivacaine 0.25 % + ' 4 mg dexamethasone in 2 mL for each nerve root .
METHODS	Visual Analogue Scale ( VAS ) was assessed .
METHODS	Duration of the first block effective pain relief was reported .
METHODS	Repeated PRF blockade was allowed for any patient who reported a VAS > 30 mm in both groups during the one year follow-up period .
METHODS	The number and duration of blocks were reported and adverse effects were also reported .
RESULTS	Significantly longer duration of pain relief was noticed in Group 1 ( P = 0.005 ) after the first block , while the durations of pain relief of the second block were comparable ( P = 0.59 ) .
RESULTS	In Group 1 the second PRF produced pain relief from the twenty-fourth week until the tenth month while in Group 2 , pain relief was reported from the sixteenth week until the eighth month after the use of PRF .
RESULTS	All patients in Group 2 received 3 blocks ( the first was a sham PRF ) during the one year follow-up period .
RESULTS	Meanwhile , 2 PRF blocks were sufficient to achieve pain relief for patients in Group 1 except 4 patients who needed a third PRF block .
RESULTS	No adverse events were reported .
CONCLUSIONS	Small sample size .
CONCLUSIONS	For intractable chronic inguinal pain , PRF for the dorsal root ganglion represents a promising treatment modality .

###24553574
BACKGROUND	Impulsivity and individual differences in subjective response to alcohol are risk factors for alcohol problems and possibly endophenotypes for alcohol dependence .
BACKGROUND	Few prior studies have addressed relationships between the two constructs .
OBJECTIVE	To predict subjective responses to ethanol , we tested self-reported impulsiveness , ethanol dose condition ( high dose , low dose , or placebo ) , and time ( seven time points ) along with interactions among these variables .
METHODS	The present study is a secondary analysis of data from a within-subject , placebo-controlled , dose-ranging ethanol administration study using IV infusion with a clamping technique to maintain steady-state breath alcohol concentration .
METHODS	The sample consisted of healthy , non-alcohol dependent social alcohol drinkers between the ages of 21 and 30 ( N = 105 ) .
METHODS	Participants at varying levels of impulsivity were compared with regard to stimulant and subjective responses to three ethanol dose conditions over time .
RESULTS	Individuals with higher impulsivity reported elavated stimulant and dampened sedative response to alcohol , particularly at the higher dose .
RESULTS	Higher impulsivity was associated with a steeper increase in stimulant effects during the first half of clamped ethanol infusion with the higher dose .
CONCLUSIONS	These results suggest that impulsive individuals may experience enhanced reinforcing , stimulant effects , and relatively muted aversive sedative effects from alcohol .
CONCLUSIONS	These subjective responses may relate to enhanced risk of alcohol problems among more impulsive individuals .

###24246597
OBJECTIVE	Kangaroo care ( KC ) has possible benefits for promoting physiological stability and positive developmental outcomes in preterm infants .
OBJECTIVE	The purpose of this study was to compare bradycardia and oxygen desaturation events in preterm infants in standard incubator care versus KC .
METHODS	Thirty-eight infants 27 to 30 weeks gestational age were randomly assigned to 2 hours of KC daily between days of life 5 to 10 or to standard incubator care .
METHODS	Infants were monitored for bradycardia ( heart rate < 80 ) or oxygen desaturation ( < 80 % ) .
METHODS	Analysis of hourly events was based on three sets of data : standard care group 24 hours daily , KC group during incubator time 22 hours daily , and KC group during holding time 2 hours daily .
RESULTS	The KC group had fewer bradycardia events per hour while being held compared to time spent in an incubator ( p = 0.048 ) .
RESULTS	The KC group also had significantly fewer oxygen desaturation events while being held than while in the incubator ( p = 0.017 ) and significantly fewer desaturation events than infants in standard care ( p = 0.02 ) .
CONCLUSIONS	KC reduces bradycardia and oxygen desaturation events in preterm infants , providing physiological stability and possible benefits for neurodevelopmental outcomes .

###25974999
BACKGROUND	Several studies have demonstrated that soluble receptor of advanced glycation end-products ( sRAGE ) is a valuable inflammatory biomarker in cardiovascular disease ( CVD ) .
BACKGROUND	Remote ischaemic conditioning may rescue myocardial tissue during acute myocardial infarction ( AMI ) .
BACKGROUND	In the present study , we evaluate whether sRAGE is a helpful biomarker in patients with AMI receiving remote ischaemic conditioning .
METHODS	Plasma sRAGE levels were measured in 191 patients with ST-elevation myocardial infarction ( STEMI ) treated with primary percutaneous intervention ( pPCI ) of which 97 patients were randomised to receive remote ischaemic conditioning .
RESULTS	The sRAGE levels were not different when compared to the randomised controls .
RESULTS	In 122 patients , measurement of myocardial salvage index ( SI ) was obtained .
RESULTS	Patients who received remote ischaemic conditioning had significantly higher SI compared to the controls ( p < 0.03 ) , although this effect was not seen in sRAGE concentrations .
RESULTS	However , sRAGE levels increased with higher New York Heart Association ( NYHA ) classification after 30 days of follow-up .
CONCLUSIONS	sRAGE levels do not reflect increased SI in AMI patients who received remote ischaemic conditioning prior to hospital admission .

###24471250
OBJECTIVE	Primary objective of this study was to compare the efficacy of Prasugrel vs. Clopidogrel in the patients with acute coronary syndromes ( ACS ) undergoing percutaneous coronary intervention ( PCI ) by measuring inhibition of platelet aggregation after loading and maintenance dose of both the drugs .
OBJECTIVE	The patients were also assessed for safety of the drugs .
METHODS	This was a randomised , double-blind , double-dummy , comparative , multicentric clinical trial in patients with acute coronary syndrome ( unstable angina , non-ST elevation MI and ST elevation MI ) undergoing PCI .
METHODS	The patients were randomly assigned to receive prasugrel ( loading dose of 60 mg followed by maintenance dose of 10-mg once daily ) or clopidogrel ( loading dose of 300 mg followed by maintenance dose of 75 mg once daily ) for a period of 12 weeks .
METHODS	All the patients were co-prescribed aspirin 325 mg with both the drugs .
METHODS	The primary efficacy end point in this study was percentage inhibition of ADP induced platelet aggregation ( IPA ) at 4 + / - 1 hours after the loading dose and at 30 + / - 3 days during maintenance treatment .
METHODS	The platelet aggregation of both the drugs was measured by whole blood aggregometer using 10 mmol of ADP as an aggregant .
METHODS	Though this study was not powered to see the difference in clinical efficacy parameters , the patients were observed for the incidence of nonfatal MI , nonfatal stroke , re-hospitalization , death , or need for urgent revascularization due to a cardiac ischemic event at days 30 and 90 during the study .
METHODS	The safety of study drugs were evaluated by incidence of major bleeding , reported adverse drug reaction and alterations of any laboratory parameters .
RESULTS	A total of 220 patients were enrolled at 11 centres across India .
RESULTS	Ten patients were given the loading dose of prasugrel or clopidogrel but did not underwent PCI due to change in investigator 's decision to go for PCI .
RESULTS	Out of 210 eligible patients , 21 patients were discontinued during the study .
RESULTS	157 patients were evaluated for platelet inhibition after loading dose at 4 hours and 150 patients at day 30 during maintenance phase of antiplalelet therapy .
RESULTS	The investigators could not perform this test in remaining patients due to urgency and criticality of the patients .
RESULTS	189 patients were observed for the incidence of nonfatal MI , nonfatal stroke , rehospitalisation , urgent revascularisation or death due to a cardiac ischemic event .
RESULTS	All eligible patients who received at least a loading dose were evalauted for safety .
RESULTS	In prasugrel group , 85 and 77 patients were evaluated for IPA at 4 hours and day 30 respectively whereas in clopdogrel group 72 and 73 patients were tested for IPA at 4 hours and at 30 days .
RESULTS	Patients in prasugrel group have demonstrated significantly higher inhibition of platelets as compared to clopidogrel group ( 82.5 % vs 71.1 % ) at 4 hours and at 30 days ( 84.1 % vs 67.4 % ) .
RESULTS	The difference in inhibition of platelets between prasugrel and clopidogrel after loading dose and maintenenace dose was statistically significant ( p < or = 0.01 ) .
RESULTS	The patients were also evaluated for drug hyporesponsiveness to antiplatelet therapy if IPA was < 20 % at day 30 from the baseline .
RESULTS	More patients on prasugrel have shown response to antiplatlet therapy than on clopidogrel ( 97.4 % vs 87.6 % ) .
RESULTS	The difference between the two groups was statistically significant ( p < 0.05 ) .
RESULTS	There was no difference observed during the study in the incidence of nonfatal MI , nonfatal stroke , death , rehospitalisation or need for urgent revascularisation due to a cardiac event between prasugrel and clopidogrel .
RESULTS	Both the drugs were found to be to be well tolerated and have comparable safety profile .
CONCLUSIONS	This study suggests that prasugrel is more effective than clopidogrel as an anti platelet drug as evident by inhibition of platelet aggregation .
CONCLUSIONS	More patients on clopidogrel are likely to have poor response to therapy as compared to prasugrel .
CONCLUSIONS	Both the drugs were well tolerated and have comparable safety profile .

###24823902
BACKGROUND	The objective of this prospective , multicenter , randomized trial was to evaluate and compare 1-year outcomes from the REMODEL study between office balloon dilation and functional endoscopic sinus surgery ( FESS ) .
METHODS	Adults with maxillary chronic rhinosinusitis ( CRS ) , including those with anterior ethmoid disease , who failed medical management and were surgical candidates for FESS , underwent either standalone balloon dilation or FESS in a 1:1 randomization scheme and were followed through a minimum of 1 year .
METHODS	Sinonasal symptom improvement was assessed using the validated 20-item Sino-Nasal Outcome Test ( SNOT-20 ) survey .
METHODS	Standardized effect sizes were computed to further assess clinical significance .
METHODS	Ostial patency rate , rhinosinusitis episode frequency , impact of sinus disease on activity and work productivity using the validated Work Productivity and Activity Impairment survey , complications , and revision rate were also compared between the two groups .
RESULTS	Ninety-two patients ( 50 balloon dilation ; 42 FESS ) were treated and 89 ( 96.7 % ) completed 1-year follow-up .
RESULTS	Both groups showed clinically meaningful and statistically significant ( p < 0.0001 ) improvement in mean overall SNOT-20 scores and in all four SNOT-20 subscales .
RESULTS	The 1-year mean change in SNOT-20 after balloon dilation ( -1.64 ) was noninferior to FESS ( -1.65 ; p < 0.001 ) .
RESULTS	The standardized effect size was large , showing clinically significant improvement for both interventions .
RESULTS	Ostial patency was 96.7 and 98.7 % after balloon dilation and FESS , respectively , and each group reported significant reductions ( p < 0.0001 ) in rhinosinusitis episodes ( mean decrease , 4.2 for balloon dilation and 3.5 for FESS ) .
RESULTS	Overall work productivity and daily activity impairment due to chronic sinusitis were significantly improved ( p < 0.001 ) in both groups .
RESULTS	There were no complications and revision surgery rate was 2 % in each arm through 1 year .
CONCLUSIONS	With 1-year follow-up , standalone balloon dilation is as effective as FESS in the treatment of CRS in patients with maxillary sinus disease with or without anterior ethmoid disease who failed medical therapy and met the criteria for medically necessary FESS .

###24881993
BACKGROUND	The fixed-dose combination of any two antihypertensive drugs from different drug classes is typically more effective in reducing blood pressure than a dose increase of component monotherapy .
BACKGROUND	We assessed the efficacy and safety of a fixed-dose combination of a vasodilating blocker ( nebivolol ) and an angiotensin II receptor blocker ( valsartan ) in adults with hypertension .
METHODS	We did an 8-week , phase 3 , multicentre , randomised , double-blind , placebo-controlled , parallel-group trial at 401 US sites .
METHODS	Participants ( age 18 years ) with hypertension but with blood pressure less than 180/110 mm Hg were randomly assigned ( 2:2:2:2:2:2:2:1 ) by a 24-h interactive web response system in blocks of 15 to 4 weeks of double-blind treatment with nebivolol and valsartan fixed-dose combination ( 5 and 80 mg/day , 5 and 160 mg/day , or 10 and 160 mg/day ) , nebivolol ( 5 mg/day or 20 mg/day ) , valsartan ( 80 mg/day or 160 mg/day ) , or placebo .
METHODS	Doses were doubled in weeks 5-8 ; results are reported according to the final dose .
METHODS	Participants and research staff were masked to treatment allocation .
METHODS	The primary and key secondary endpoints were changes from baseline to week 8 in diastolic and systolic blood pressure , respectively .
METHODS	The primary statistical comparison was between the highest fixed-dose combination dose and the highest monotherapy doses ; lower doses were then compared if this comparison was positive ( Hochberg method for multiple testing ) .
METHODS	Efficacy analyses were by intention to treat .
METHODS	Safety assessments included monitoring of adverse events .
METHODS	Continuous efficacy parameters were analysed using an ANCOVA model ; binary outcomes were analysed using a logistic regression model .
METHODS	This study is registered with ClinicalTrials.gov , NCT01508026 .
RESULTS	Between Jan 6 , 2012 , and March 15 , 2013 , 4161 patients were randomly assigned ( 277 to placebo and 554-555 to each active comparator group ) , 4118 of whom were included in the primary analysis .
RESULTS	At week 8 , the fixed-dose combination 20 and 320 mg/day group had significantly greater reductions in diastolic blood pressure from baseline than both nebivolol 40 mg/day ( least-squares mean difference -12 mm Hg , 95 % CI -23 to -01 ; p = 0030 ) and valsartan 320 mg/day ( -44 mm Hg , -54 to -33 ; p < 00001 ) ; all other comparisons were also significant , favouring the fixed-dose combinations ( all p < 00001 ) .
RESULTS	All systolic blood pressure comparisons were also significant ( all p < 001 ) .
RESULTS	At least one treatment-emergent adverse event was experienced by 30-36 % of participants in each group .
CONCLUSIONS	Nebivolol and valsartan fixed-dose combination is an effective and well-tolerated treatment option for patients with hypertension .
BACKGROUND	Forest Research Institute .

###25076139
BACKGROUND	Haemorrhage is the most common major complication of endoscopic sinus surgery .
BACKGROUND	Post-operative absorbable or non-absorbable nasal packing can cause pain and blockage .
BACKGROUND	Haemostatic powders or gels may prevent this problem .
BACKGROUND	However , when based on factors in the clotting cascade , they induce an inflammatory reaction and can cause post-operative synechiae .
BACKGROUND	Oxidised cellulose powder produces haemostasis without inducing synechiae formation , but has not been trialled for sinus surgery .
METHODS	A randomised clinical trial was performed to compare cellulose powder to non-absorbable packing following sinus surgery .
METHODS	Participants were 50 consecutive patients undergoing sinus surgery , 47 of whom completed the study .
METHODS	The main outcome measures were post-operative bleeding , pain scores and synechiae formation .
RESULTS	Cellulose powder was effective at stopping bleeding , and was associated with less pain than nasal packing , with no evidence of increased synechiae formation .
CONCLUSIONS	Cellulose powder appears to be a good haemostatic agent following sinus surgery .
CONCLUSIONS	A larger trial would allow more accurate quantification of its effectiveness .

###24816536
BACKGROUND	Pain caused by intravenous injection of the muscle relaxant rocuronium bromide is common in children and adolescents .
BACKGROUND	The cause of this unwanted effect is still unclear , and different pretreatment drugs have been administered in attempts to alleviate this side effect , with varying degrees of success .
OBJECTIVE	This study used a 60-s venous occlusion technique to evaluate the effectiveness of pretreatment with lidocaine , fentanyl , or remifentanil in preventing pain-induced withdrawal caused by intravenous injection of rocuronium bromide during the induction of general anesthesia .
METHODS	One hundred and one child and adolescent patients , ASA - II , requiring various surgical procedures under general anesthesia with muscle relaxation and mechanical ventilation , were enrolled .
METHODS	Patients were allocated randomly using computer-generated randomization into one of four pretreatment groups : a remifentanil group ( 1 g/kg , n = 25 ) , fentanyl group ( 1 g/kg , n = 26 ) , lidocaine 1 % group ( 0.5 mg/kg , n = 25 ) , and normal saline group ( n = 25 ) .
METHODS	Drug doses were prepared in normal saline to a total volume of 5 ml .
METHODS	Venous occlusion was applied 10 cm above the venous access site .
METHODS	Pretreatment drugs were injected and retained for 60 s at the site of injection by an anesthetist blinded to group allocation .
METHODS	After release of the tourniquet , rocuronium ( 0.5 mg/kg ) was then injected over 5 s , and withdrawal was recorded by another anesthetist blinded to group allocation .
METHODS	Descriptive statistics , analysis of variance , and a chi-squared test were used to statistically analyze the results as appropriate .
RESULTS	Compared to normal saline , all other pretreatment groups scored a significantly lower mean of withdrawal response ( P < 0.001 ) .
RESULTS	Lidocaine was superior to both remifentanil ( P < 0.05 ) and fentanyl ( P < 0.05 ) in suppressing the withdrawal response to rocuronium injection .
RESULTS	Remifentanil was superior to fentanyl in suppressing the withdrawal response caused by rocuronium injection ( P < 0.001 ) .
CONCLUSIONS	Using a venous occlusion technique for 60 s , lidocaine was found to be most effective in preventing the withdrawal effect caused by rocuronium injection in children and adolescents .
CONCLUSIONS	Lidocaine was superior to remifentanil which , in turn , was more effective than fentanyl .

###24908205
OBJECTIVE	To evaluate the 3-year incremental cost-effectiveness of fluocinolone acetonide implant versus systemic therapy for the treatment of noninfectious intermediate , posterior , and panuveitis .
METHODS	Randomized , controlled , clinical trial .
METHODS	Patients with active or recently active intermediate , posterior , or panuveitis enrolled in the Multicenter Uveitis Steroid Treatment Trial .
METHODS	Data on cost and health utility during 3 years after randomization were evaluated at 6-month intervals .
METHODS	Analyses were stratified by disease laterality at randomization ( 31 unilateral vs 224 bilateral ) because of the large upfront cost of the implant .
METHODS	The primary outcome was the incremental cost-effectiveness ratio ( ICER ) over 3 years : the ratio of the difference in cost ( in United States dollars ) to the difference in quality-adjusted life-years ( QALYs ) .
METHODS	Costs of medications , surgeries , hospitalizations , and regular procedures ( e.g. , laboratory monitoring for systemic therapy ) were included .
METHODS	We computed QALYs as a weighted average of EQ-5D scores over 3 years of follow-up .
RESULTS	The ICER at 3 years was $ 297,800 / QALY for bilateral disease , driven by the high cost of implant therapy ( difference implant - systemic [ ] : $ 16,900 ; P < 0.001 ) and the modest gains in QALYs ( = 0.057 ; P = 0.22 ) .
RESULTS	The probability of the ICER being cost-effective at thresholds of $ 50,000 / QALY and $ 100,000 / QALY was 0.003 and 0.04 , respectively .
RESULTS	The ICER for unilateral disease was more favorable , namely , $ 41,200 / QALY at 3 years , because of a smaller difference in cost between the 2 therapies ( = $ 5300 ; P = 0.44 ) and a larger benefit in QALYs with the implant ( = 0.130 ; P = 0.12 ) .
RESULTS	The probability of the ICER being cost-effective at thresholds of $ 50,000 / QALY and $ 100,000 / QALY was 0.53 and 0.74 , respectively .
CONCLUSIONS	Fluocinolone acetonide implant therapy was reasonably cost-effective compared with systemic therapy for individuals with unilateral intermediate , posterior , or panuveitis but not for those with bilateral disease .
CONCLUSIONS	These results do not apply to the use of implant therapy when systemic therapy has failed or is contraindicated .
CONCLUSIONS	Should the duration of implant effect prove to be substantially > 3 years or should large changes in therapy pricing occur , the cost-effectiveness of implant versus systemic therapy would need to be reevaluated .

###24615306
OBJECTIVE	This trial was designed to evaluate the optimal dose of massage for individuals with chronic neck pain .
METHODS	We recruited 228 individuals with chronic nonspecific neck pain from an integrated health care system and the general population , and randomized them to 5 groups receiving various doses of massage ( a 4-week course consisting of 30-minute visits 2 or 3 times weekly or 60-minute visits 1 , 2 , or 3 times weekly ) or to a single control group ( a 4-week period on a wait list ) .
METHODS	We assessed neck-related dysfunction with the Neck Disability Index ( range , 0-50 points ) and pain intensity with a numerical rating scale ( range , 0-10 points ) at baseline and 5 weeks .
METHODS	We used log-linear regression to assess the likelihood of clinically meaningful improvement in neck-related dysfunction ( 5 points on Neck Disability Index ) or pain intensity ( 30 % improvement ) by treatment group .
RESULTS	After adjustment for baseline age , outcome measures , and imbalanced covariates , 30-minute treatments were not significantly better than the wait list control condition in terms of achieving a clinically meaningful improvement in neck dysfunction or pain , regardless of the frequency of treatments .
RESULTS	In contrast , 60-minute treatments 2 and 3 times weekly significantly increased the likelihood of such improvement compared with the control condition in terms of both neck dysfunction ( relative risk = 3.41 and 4.98 , P = .04 and .005 , respectively ) and pain intensity ( relative risk = 2.30 and 2.73 ; P = .007 and .001 , respectively ) .
CONCLUSIONS	After 4 weeks of treatment , we found multiple 60-minute massages per week more effective than fewer or shorter sessions for individuals with chronic neck pain .
CONCLUSIONS	Clinicians recommending massage and researchers studying this therapy should ensure that patients receive a likely effective dose of treatment .

###24603643
BACKGROUND	Antiemetic guidelines recommend co-administration of agents that target multiple molecular pathways involved in emesis to maximize prevention and control of chemotherapy-induced nausea and vomiting ( CINV ) .
BACKGROUND	NEPA is a new oral fixed-dose combination of 300 mg netupitant , a highly selective NK1 receptor antagonist ( RA ) and 0.50 mg palonosetron ( PALO ) , a pharmacologically and clinically distinct 5-HT3 RA , which targets dual antiemetic pathways .
METHODS	This multinational , randomized , double-blind , parallel group phase III study ( NCT01339260 ) in 1455 chemotherapy-nave patients receiving moderately emetogenic ( anthracycline-cyclophosphamide ) chemotherapy evaluated the efficacy and safety of a single oral dose of NEPA versus a single oral dose ( 0.50 mg ) of PALO .
METHODS	All patients also received oral dexamethasone ( DEX ) on day 1 only ( 12 mg in the NEPA arm and 20 mg in the PALO arm ) .
METHODS	The primary efficacy end point was complete response ( CR : no emesis , no rescue medication ) during the delayed ( 25-120 h ) phase in cycle 1 .
RESULTS	The percentage of patients with CR during the delayed phase was significantly higher in the NEPA group compared with the PALO group ( 76.9 % versus 69.5 % ; P = 0.001 ) , as were the percentages in the overall ( 0-120 h ) ( 74.3 % versus 66.6 % ; P = 0.001 ) and acute ( 0-24 h ) ( 88.4 % versus 85.0 % ; P = 0.047 ) phases .
RESULTS	NEPA was also superior to PALO during the delayed and overall phases for all secondary efficacy end points of no emesis , no significant nausea and complete protection ( CR plus no significant nausea ) .
RESULTS	NEPA was well tolerated with a similar safety profile as PALO .
CONCLUSIONS	NEPA plus a single dose of DEX was superior to PALO plus DEX in preventing CINV following moderately emetogenic chemotherapy in acute , delayed and overall phases of observation .
CONCLUSIONS	As a fixed-dose antiemetic drug combination , NEPA along with a single dose of DEX on day 1 offers guideline-based prophylaxis with a convenient , single-day treatment .

###24693784
OBJECTIVE	To explore the feasibility and effectiveness of unilateral pedicle screw rod and single poly ( ether-ether-ketone ) ( PEEK ) Cage for lumbar intervertebral disc protrusion .
METHODS	A total of 126 cases of single segment of lumbar intervertebral disc protrusion between January 2006 and June 2012 were divided into 2 groups in the randomized clinical trial .
METHODS	Unilateral pedicle screw fixation and single PEEK Cage was used in 63 cases ( research group ) , and bilateral pedicle screw fixation and single PEEK Cage in 63 cases ( control group ) .
METHODS	There was no significant difference in gender , age , disease duration , side , and affected segment between 2 groups ( P > 0.05 ) .
METHODS	Schulte evaluation criterion was used to assess bone graft fusion , Oswestry disability index ( ODI ) to estimate the quality of life situation , and visual analogue scale ( VAS ) to evaluate the improvements of lower back pain .
METHODS	Macnab standards was applied to assess postoperative effectiveness , and Emery ways to measure the height of intervertebral space .
RESULTS	The incision length , operation time , intraoperative blood loss , hospitalization time , and hospitalization fee in research group were significantly less than those in control group ( P cc 0.05 ) .
RESULTS	The patients were followed up 12-79 months ( mean , 21.3 months ) in research group , and 15-73 months ( mean , 22.6 months ) in control group .
RESULTS	The postoperative lordosis was recovered well , and the height of intervertebral space was increased .
RESULTS	No loosening or breakage of internal fixation occurred .
RESULTS	The time of bone graft fusion was ( 6.8 + / - 1.3 ) months in research group and was ( 7.1 + / - 1.2 ) months in control group , showing no significant difference ( t = 1.153 , P = 0.110 ) .
RESULTS	The height of intervertebral space , ODI score , and VAS score were significantly improved when compared with preoperative ones in 2 groups ( P < 0.05 ) , but no significant difference was found between 2 groups at preoperation and last follow-up ( P > 0.05 ) .
RESULTS	At 3 months after operation , postoperative effectiveness was assessed according to Macnab criterion , the excellent and good rate was 95.23 % in research group ( excellent in 13 cases , good in 47 cases , and fair in 3 cases ) and was 71.42 % in control group ( excellent in 7 cases , good in 38 cases , fair in 15 cases , and poor in 3 cases ) ; the research group was significantly superior to control group ( chi2 = 6.110 , P = 0.006 ) .
CONCLUSIONS	Unilateral pedicle screw fixation and single PEEK Cage has the advantages of small trauma , reliable fixation , shorter operation time , less bleeding , less economic cost , and early off-bed activity time .
CONCLUSIONS	It can provide a simple and reliable choice in single segmental lumbar intervertebral disc protrusion .

###24886626
BACKGROUND	It is unknown whether individuals at high cardiovascular risk sustain a benefit in cardiovascular disease from increased olive oil consumption .
BACKGROUND	The aim was to assess the association between total olive oil intake , its varieties ( extra virgin and common olive oil ) and the risk of cardiovascular disease and mortality in a Mediterranean population at high cardiovascular risk .
METHODS	We included 7,216 men and women at high cardiovascular risk , aged 55 to 80 years , from the PREvencin con DIeta MEDiterrnea ( PREDIMED ) study , a multicenter , randomized , controlled , clinical trial .
METHODS	Participants were randomized to one of three interventions : Mediterranean Diets supplemented with nuts or extra-virgin olive oil , or a control low-fat diet .
METHODS	The present analysis was conducted as an observational prospective cohort study .
METHODS	The median follow-up was 4.8 years .
METHODS	Cardiovascular disease ( stroke , myocardial infarction and cardiovascular death ) and mortality were ascertained by medical records and National Death Index .
METHODS	Olive oil consumption was evaluated with validated food frequency questionnaires .
METHODS	Multivariate Cox proportional hazards and generalized estimating equations were used to assess the association between baseline and yearly repeated measurements of olive oil intake , cardiovascular disease and mortality .
RESULTS	During follow-up , 277 cardiovascular events and 323 deaths occurred .
RESULTS	Participants in the highest energy-adjusted tertile of baseline total olive oil and extra-virgin olive oil consumption had 35 % ( HR : 0.65 ; 95 % CI : 0.47 to 0.89 ) and 39 % ( HR : 0.61 ; 95 % CI : 0.44 to 0.85 ) cardiovascular disease risk reduction , respectively , compared to the reference .
RESULTS	Higher baseline total olive oil consumption was associated with 48 % ( HR : 0.52 ; 95 % CI : 0.29 to 0.93 ) reduced risk of cardiovascular mortality .
RESULTS	For each 10 g/d increase in extra-virgin olive oil consumption , cardiovascular disease and mortality risk decreased by 10 % and 7 % , respectively .
RESULTS	No significant associations were found for cancer and all-cause mortality .
RESULTS	The associations between cardiovascular events and extra virgin olive oil intake were significant in the Mediterranean diet intervention groups and not in the control group .
CONCLUSIONS	Olive oil consumption , specifically the extra-virgin variety , is associated with reduced risks of cardiovascular disease and mortality in individuals at high cardiovascular risk .
BACKGROUND	This study was registered at controlled-trials .
BACKGROUND	com ( http://www.controlled-trials.com/ISRCTN35739639 ) .
BACKGROUND	International Standard Randomized Controlled Trial Number ( ISRCTN ) : 35739639 .
BACKGROUND	Registration date : 5 October 2005 .

###24332569
BACKGROUND	Haemodialysis patients may suffer from pain and impairment of quality of life .
BACKGROUND	Some complementary interventions , such as relaxation therapy , might affect the pain and quality of life .
BACKGROUND	The present study aimed to identify the effectiveness of Benson 's relaxation technique in relieving pain and improving the quality of life in haemodialysis patients .
METHODS	The study was a randomized controlled trial .
METHODS	The data were collected in two haemodialysis units affiliated to Shiraz University of Medical Sciences .
METHODS	A total of 86 haemodialysis patients were randomly assigned to either the intervention ( receiving Benson 's relaxation technique ) or the control group ( routine care ) from 2011 to 2012 .
METHODS	The patients in the intervention groups listened to the audiotape of relaxation technique twice a day each time for 20min for eight weeks .
METHODS	The pain numeric rating scale and Ferrans and Powers Quality of Life Index-dialysis version questionnaire were completed at baseline and 8 weeks after the intervention .
METHODS	The data were analyzed using independent t-test and ANCOVA .
RESULTS	The results of ANCOVA showed a significant difference between the intervention and the control group concerning the mean score of the intensity of pain ( F = 6.03 , p = 0.01 ) .
RESULTS	Moreover , a significant difference was found between the intervention and the control group regarding the total quality of life ( F = 10.20 , p = 0.002 ) and health-functioning ( F = 8.64 , p = 0.004 ) , socioeconomic ( F = 12.45 , p = 0.001 ) , and family ( F = 8.52 , p = 0.005 ) subscales of quality of life .
CONCLUSIONS	These findings indicated that Benson 's relaxation technique might relieve the intensity of pain and improve the quality of life in haemodialysis patients .
CONCLUSIONS	Thus , Benson 's relaxation technique could be used as part of the care practice for relieving the pain intensity and improvement of the quality of life in haemodialysis patients .

###25747273
OBJECTIVE	No adjuvant therapy has been shown to extend the survival of patients with hepatocellular carcinoma ( HCC ) receiving curative treatment .
OBJECTIVE	We investigated whether injections of activated cytokine-induced killer ( CIK ) cells ( CD3 + / CD56 + and CD3 + / CD56 - T cells and CD3 - / CD56 + natural killer cells ) prolongs recurrence-free survival of patients after curative therapy for HCC .
METHODS	We performed a multicenter , randomized , open-label , phase 3 trial of the efficacy and safety of adjuvant immunotherapy with activated CIK cells ( created by incubation of patients ' peripheral blood mononuclear cells with interleukin 2 and an antibody against CD3 ) .
METHODS	The study included 230 patients with HCC treated by surgical resection , radiofrequency ablation , or percutaneous ethanol injection at university-affiliated hospitals in Korea .
METHODS	Patients were assigned randomly to receive immunotherapy ( injection of 6.4 10 ( 9 ) autologous CIK cells , 16 times during 60 weeks ) or no adjuvant therapy ( controls ) .
METHODS	The primary end point was recurrence-free survival ; secondary end points included overall survival , cancer-specific survival , and safety .
RESULTS	The median time of recurrence-free survival was 44.0 months in the immunotherapy group and 30.0 months in the control group ( hazard ratio with immunotherapy , 0.63 ; 95 % confidence interval [ CI ] , 0.43-0 .94 ; P = .010 by 1-sided log-rank test ) .
RESULTS	Hazard ratios also were lower in the immunotherapy than in the control group for all-cause death ( 0.21 ; 95 % CI , 0.06-0 .75 ; P = .008 ) and cancer-related death ( 0.19 ; 95 % CI , 0.04-0 .87 ; P = .02 ) .
RESULTS	A significantly higher proportion of patients in the immunotherapy group than in the control group had an adverse event ( 62 % vs 41 % ; P = .002 ) , but the proportion of patients with serious adverse events did not differ significantly between groups ( 7.8 % vs 3.5 % ; P = .15 ) .
CONCLUSIONS	In patients who underwent curative treatment for HCC , adjuvant immunotherapy with activated CIK cells increased recurrence-free and overall survival .
CONCLUSIONS	ClinicalTrials.gov number : NCT00699816 .

###24311703
BACKGROUND	Dedicated coronary computed tomography ( CT ) scan has been proven to be an accurate diagnostic modality in evaluating coronary artery disease .
BACKGROUND	A second phase scan starting immediately after the coronary CT scan might enable visualization of the different vascular territories of the entire chest .
OBJECTIVE	To investigate the feasibility of a contrast material and radiation dose reduction triple-rule-out ( TRO ) CT angiography ( CTA ) protocol with serial non-ECG-gated low kVp scan of the whole chest , which utilizes a recirculated contrast agent .
METHODS	Thirty patients were scanned with the new TRO-CTA protocol ; after the coronary scan with retrospective ECG-gating , non-ECG-gated whole-chest CTA was performed at 80 kVp to evaluate aortic arch ( AAr ) and pulmonary trunk ( PT ) .
METHODS	Another 30 patients were scanned by our conventional TRO-CTA protocol at 120 kVp with retrospective ECG-gating .
METHODS	We compared the estimated effective dose ( ED ) , contrast material ( CM ) dose , contrast-to-noise ratio ( CNR ) of the ascending aorta ( AAo ) , and the rate of patients who could achieve adequate attenuation of the AAr and PT between the two protocols .
RESULTS	The total ED of the new TRO-CTA protocol was 29.6 % lower than that of the conventional protocol ( P < 0.01 ) .
RESULTS	The amount of CM used for the new TRO-CTA protocol was significantly lower than in the conventional protocol ( 60.1 9.6 mL vs. 91.8 22.6 mL , P < 0.01 ) .
RESULTS	The CNR of the AAo was 30.2 % higher with the new TRO-CTA protocol than with the conventional protocol ( P < 0.01 ) .
RESULTS	There was no significant difference in the success rate of adequate attenuation of the AAr and PT between the two protocols ( P > 0.05 ) .
CONCLUSIONS	The new TRO-CTA protocol can reduce the total dose of radiation and the contrast dose and yield adequate vascular enhancement compared with the conventional protocol .

###24479853
OBJECTIVE	The objectives of this study were to examine whether a leisure education program could facilitate leisure competence among older adults and whether it could also reduce their stress .
METHODS	A pre-test-post-test randomized experimental design was conducted .
METHODS	Subjects were randomly assigned to either an experimental group ( n = 30 ) or a control group ( n = 30 ) .
METHODS	A leisure education program was used to serve as the intervention .
METHODS	A day before this experiment was carried out , pre-test data were collected using leisure competence and stress scales .
METHODS	Thirty minutes after this experiment ended , post-test data were collected using the same scales .
METHODS	These data were analyzed using an analysis of covariance .
RESULTS	The results indicated that the average post-test scores of leisure competence in the experimental group were significantly higher than those in the control group and that the average post-test scores of stress in the experimental group were significantly lower than those in the control group .
CONCLUSIONS	Healthcare practitioners should adopt the provision of leisure education as a priority to facilitate leisure competence and reduce stress among older adults .

###25537538
OBJECTIVE	To understand the effect of lung recruitment maneuver ( LRM ) with positive end-expiratory pressure ( PEEP ) on oxygenation and outcomes in preterm infants with respiratory distress syndrome ( RDS ) ventilated by proportional assist ventilation ( PAV ) .
METHODS	From January 2012 to June 2013 , thirty neonates with a diagnosis of RDS who required mechanical ventilation were divided randomly into LRM group ( n = 15 , received an LRM and surport by PAV ) and control group ( n = 15 , only surport by PAV ) .
METHODS	There were no statistically significant differences in female ( 7 vs. 6 ) ; gestational age [ ( 29.31.2 ) vs. ( 29.51.1 ) weeks ] ; body weight [ ( 1,31997 ) vs. ( 1,29585 ) g ] ; Silverman Anderson ( SA ) score for babies at start of ventilation ( 7.31.2 vs. 6.91.4 ) ; initial FiO2 ( 0.540.12 vs. 0.500.10 ) between the two groups ( all P > 0.05 ) .
METHODS	LRM entailed increments of 0.2 cmH2O ( 1 cmH2O = 0.098 kPa ) PEEP every 5 minutes , until fraction of inspired oxygen ( FiO2 ) = 0.25 .
METHODS	Then PEEP was reduced and the lung volume was set on the deflation limb of the pressure/volume curve.When saturation of peripheral oxygen fell and FiO2 rose , we reincremented PEEP until SpO2 became stable .
METHODS	The related clinical indicators of the two group were observed .
RESULTS	The doses of surfactant administered ( 1.10.3 vs. 1.50.5 , P = 0.027 ) , Lowest FiO2 ( 0.290.05 vs. 0.390.06 , P = 0.000 ) , time to lowest FiO2 [ ( 10318 ) vs. ( 368138 ) min , P = 0.000 ] and O2 dependency [ ( 7.61.0 ) vs. ( 8.81.3 ) days , P = 0.021 ] in LRM group were lower than that in control group ( all P < 0.05 ) .
RESULTS	The maximum PEEP during the first 12 hours of life [ ( 8.40.8 ) vs. ( 6.80.8 ) cmH2O , P = 0.000 ] in LRM group were higher than that in control group ( P < 0.05 ) .
RESULTS	FiO2 levels progressively decreased ( F = 35.681 , P = 0.000 ) and a/AO2 Gradually increased ( F = 37.654 , P = 0.000 ) .
RESULTS	No adverse events and no significant differences in the outcomes were observed .
CONCLUSIONS	LRM can reduce the doses of pulmonary surfactant administered , time of the respiratory support and the oxygen therapy in preterm children with RDS .

###24789332
OBJECTIVE	Through comprehensive ophthalmic examination of adult offspring we sought to determine the impact of multiple prenatal ultrasound scans on ocular development .
METHODS	2743 pregnant women recruited to the Western Australian Pregnancy ( Raine ) Cohort study during 1989-1991 were randomized to receive at King Edward Memorial Hospital , Western Australia either multiple prenatal ultrasound scans and Doppler flow studies ( intensive group ) or a single ultrasound scan at 18 weeks ' gestation .
METHODS	Neonatal birth weight of the offspring and other physical measurements were collected prospectively .
METHODS	At age 20 years , participants underwent a comprehensive ophthalmic examination including measurement of ocular biometry and visual acuity .
RESULTS	Complete data were available for 1134 adult offspring participants .
RESULTS	The mothers of 563 of these had been randomized to receive multiple prenatal ultrasound scans .
RESULTS	The mean age of participants at follow-up was 20.0 years .
RESULTS	There was no statistically significant difference between the two groups with regard to ocular biometric or visual outcomes , except for slightly higher intraocular pressure identified in individuals exposed to multiple ultrasound scans ( P = 0.034 ) .
RESULTS	Although infants in the intensive-ultrasound arm were more likely to have birth weights in the lower quartiles , this was not reflected in adult eye development .
RESULTS	Axial length , lens thickness , corneal curvature and thickness and optic cup to disc ratio ( a risk factor for glaucomatous optic neuropathy ) were not significantly influenced by the more frequent ultrasound protocol .
CONCLUSIONS	Prior to this study , there was a paucity of safety data for ultrasound with regard to eye development .
CONCLUSIONS	We found that frequent in-utero exposure to ultrasound , including B-mode imaging and the use of spectral Doppler mode from 18 weeks ' gestation , had no significant impact on visual outcomes or ocular biometry .

###24349385
BACKGROUND	Escalating weight gain among the Malaysian paediatric population necessitates identifying modifiable behaviours in the obesity pathway .
OBJECTIVE	This study describes the adaptation and validation of the Children 's Eating Behaviour Questionnaire ( CEBQ ) as a self-report for adolescents , investigates gender and ethnic differences in eating behaviour and examines associations between eating behaviour and body mass index ( BMI ) z-scores among multi-ethnic Malaysian adolescents .
METHODS	This two-phase study involved validation of the Malay self-reported CEBQ in Phase 1 ( n = 362 ) .
METHODS	Principal Axis Factoring with Promax rotation , confirmatory factor analysis and reliability tests were performed .
METHODS	In Phase 2 , adolescents completed the questionnaire ( n = 646 ) .
METHODS	Weight and height were measured .
METHODS	Gender and ethnic differences in eating behaviour were investigated .
METHODS	Associations between eating behaviour and BMI z-scores were examined with complex samples general linear model ( GLM ) analyses , adjusted for gender , ethnicity and maternal educational level .
RESULTS	Exploratory factor analysis revealed a 35-item , 9-factor structure with ` food fussiness ' scale split into two .
RESULTS	In confirmatory factor analysis , a 30-item , 8-factor structure yielded an improved model fit .
RESULTS	Reliability estimates of the eight factors were acceptable .
RESULTS	Eating behaviours did not differ between genders .
RESULTS	Malay adolescents reported higher Food Responsiveness , Enjoyment of Food , Emotional Overeating , Slowness in Eating , Emotional Undereating and Food Fussiness 1 scores ( p < 0.05 ) compared to Chinese and Indians .
RESULTS	A significant negative association was observed between BMI z-scores and Food Fussiness 1 ( ` dislike towards food ' ) when adjusted for confounders .
CONCLUSIONS	Although CEBQ is a valuable psychometric instrument , adjustments were required due to age and cultural differences in our sample .
CONCLUSIONS	With the self-report , our findings present that gender , ethnic and weight status influenced eating behaviours .
CONCLUSIONS	Obese adolescents were found to display a lack of dislike towards food .
CONCLUSIONS	Future longitudinal and qualitative studies are warranted to further understand behavioural phenotypes of obesity to guide prevention and intervention strategies .

###24717711
OBJECTIVE	This study 's purpose was to determine whether rinsing with water or cleansing teeth after topical fluoride therapy affected plaque acidity .
METHODS	This randomized , controlled , crossover , in situ study was conducted on 25 dental students who wore an acrylic mandibular appliance containing one enamel block .
METHODS	The patients were subjected to four treatment protocols involving acidulated phosphate fluoride ( APF ) application followed by rinsing the mouth with water : ( 1 ) after 30 minutes ( APF-30 ) ; ( 2 ) after 15 minutes ( APF-15 ) ; ( 3 ) immediately ( APF-0 ) ; after cleansing the teeth with a cotton roll immediately following APF ( APF-cotton ) ; or ( 4 ) no fluoride therapy ( control ) .
METHODS	After 48 hours , plaque pH was measured before and five , 10 , 15 , 20 , and 30 minutes after rinsing with 10 percent sucrose solution .
RESULTS	The least pH changes , the lowest pH drop , and the fastest pH recovery were found in the APF-30 and APF-15 groups , followed by the APF-0 and APF-cotton groups .
CONCLUSIONS	Rinsing with water or cleansing the teeth with a cotton roll immediately after acidulated phosphate fluoride application can reduce its effect on dental plaque acidity ; however , the inclusion of a controlled water rinse 15 minutes after APF gel application did not seem to influence the inhibitory effect of fluoride on plaque acidity .

###24373114
OBJECTIVE	The study aimed to create and evaluate the educational effectiveness of a digital resource instructing paediatric trainees in a systematic approach to critical and quality observation of normal child development .
METHODS	A digital educational resource was developed utilising the skills of an expert developmental paediatrician who was videoed assessing normal early child development at a series of critical stages .
METHODS	Videos illustrated aspects of language , sophistication of play and socialisation , cognition , and motor progress .
METHODS	Expert commentary , teaching text and summaries were used .
METHODS	A randomised controlled trial evaluated the resource .
METHODS	Paediatric trainees were recruited from The Sydney Children 's Hospitals Network .
METHODS	Outcome measures were repeated at three time points ( pre-teaching , immediate-post and 1 month ) and included self-rated attitudes , knowledge of markers of development and observational expertise .
METHODS	Qualitative data on teaching usefulness were obtained through open-ended questions .
RESULTS	Fifty-six paediatric trainees ( registrar 79 % , women 82 % ; mean age 31 years ) completed the pre-assessment , 46 the immediate-post and 45 the 1-month follow-up ( 20 % attrition ) .
RESULTS	Compared with the Control group , the Teaching group scored higher over time on markers of development ( P = 0.006 ) , observational expertise ( P < 0.0001 ) , confidence ( P = 0.035 ) and satisfaction ( P < 0.0001 ) .
RESULTS	Teaching participants valued the video and expert commentary and reported improvement in confidence and understanding and acquiring a more structured approach .
CONCLUSIONS	The ` Beyond Milestones ' free online resource for medical professionals < http://learnpaediatrics.org/beyondmilestones/ password = cunningham > improves knowledge , increases confidence and is useful , providing a structured approach to developmental assessment .
CONCLUSIONS	The techniques taught can be applied to every paediatric consultation .

###24335695
BACKGROUND	The randomized controlled Pediatric Oncology Group study 9233 tested the hypothesis that dose-intensive ( DI ) chemotherapy would improve event-free survival ( EFS ) for children < 3 years of age with newly diagnosed malignant brain tumors .
METHODS	Of 328 enrolled eligible patients , diagnoses were medulloblastoma ( n = 112 ) , ependymoma ( n = 82 ) , supratentorial primitive neuroectodermal tumor ( sPNET , n = 38 ) and other malignant brain tumors ( n = 96 ) , and were randomized to 72 weeks of standard dose chemotherapy ( Regimen A , n = 162 ) or DI chemotherapy ( Regimen B , n = 166 ) .
METHODS	Radiation therapy ( RT ) was recommended for patients with evidence of disease at completion of chemotherapy or who relapsed within 6 months of chemotherapy completion .
RESULTS	Distributions of EFS for Regimens A and B were not significantly different ( P = 0.32 ) with 2 - and 10-year rates of 22.8 % 3.3 % and 15.4 % 3.7 % , and 27.1 % 3.4 % and 20.8 % 3.8 % , respectively .
RESULTS	Thus , the study hypothesis was rejected .
RESULTS	While distributions of EFS and OS were not significantly different between Regimens A and B for patients with medulloblastoma and sPNET , DI chemotherapy resulted in significantly improved EFS distribution ( P = .0011 ) ( 2-year EFS rates of 42.1 % vs. 19.6 % with SD chemotherapy ) , but not OS distribution , for patients with centrally confirmed ependymoma .
RESULTS	The degree of surgical resection affected EFS , OS or both for most tumor groups .
RESULTS	Approximately 20 % , 40 % and 20 % of patients with medulloblastoma , ependymoma treated with DI chemotherapy , and sPNET , respectively appear to have been cured without RT. .
RESULTS	Of 11 toxic deaths on study , 10 occurred on the DI chemotherapy arm .
CONCLUSIONS	Prolonged dose-intensive chemotherapy given to infants with malignant brain tumors resulted in increased EFS only for patients with ependymoma .

###24621587
OBJECTIVE	The purpose of this prospective , attention-controlled , randomized study was to determine whether postoperative gum chewing reduces the duration of postoperative ileus symptoms following elective open or laparoscopic sigmoid colectomy when compared with standard care or an attention-control intervention .
METHODS	Forty-seven subjects scheduled for either an open or laparoscopic colon resection participated in the study .
METHODS	Subjects were recruited preoperatively at the preadmission learning centers of the 2 acute care medical centers that comprised the study settings .
METHODS	Subjects were randomized to 3 groups : ( 1 ) standard postoperative care ( n = 18 ) ; ( 2 ) standard care and a silicone-adhesive patch applied to the deltoid region of the upper arm as an attention control ( n = 16 ) ; and ( 3 ) standard care and gum chewing ( n = 13 ) .
METHODS	Standard postoperative care included removal of the nasogastric tube , early ambulation , nothing by mouth with ice chips only until the first passage of flatus , and then advancement of diet until tolerance of solid food .
RESULTS	No statistically significant differences were found among the 3 study groups for the 4 postoperative outcome variables measured : ( 1 ) first passage of flatus ; ( 2 ) first bowel movement ; ( 3 ) return of hunger ; and ( 4 ) ability to tolerate solid food for one meal .
CONCLUSIONS	Postoperative gum chewing was not found to be more effective than standard postoperative care or our attention-control intervention in reducing the duration of postoperative ileus symptoms , length of stay , or complications among patients following open/laparoscopic sigmoid colectomy .

###24225332
OBJECTIVE	Increasingly , low-income inner-city patients with diabetes utilize emergency departments ( EDs ) for acute and chronic care .
OBJECTIVE	We seek to determine whether a scalable , low-cost , unidirectional , text message-based mobile health intervention ( TExT-MED ) improves clinical outcomes , increases healthy behaviors , and decreases ED utilization in a safety net population .
METHODS	We conducted an randomized controlled trial of 128 adult patients with poorly controlled diabetes ( glycosylated hemoglobin [ Hb A1C ] level 8 % ) in an urban , public ED .
METHODS	The TExT-MED group received 2 daily text messages for 6 months in English or Spanish .
METHODS	The primary outcome was change in Hb A1C level .
METHODS	Secondary outcomes included changes in medication adherence , self-efficacy , performance of self-care tasks , quality of life , diabetes-specific knowledge , ED utilization , and patient satisfaction .
RESULTS	Hb A1C level decreased by 1.05 % in the TExT-MED group compared with 0.60 % in the controls ( 0.45 ; 95 % confidence interval [ CI ] -0.27 to 1.17 ) at 6 months .
RESULTS	Secondary outcomes favored the TExT-MED group , with the most sizable change observed in self-reported medication adherence ( as measured by the Morisky Medication Adherence Scale , an 8-point validated scale with higher scores representing better adherence ) , which improved from 4.5 to 5.4 in the TExT-MED group compared with a net decrease of -0.1 in the controls ( 1.1 [ 95 % CI 0.1 to 2.1 ] ) .
RESULTS	Effects were larger among Spanish speakers for both medication adherence ( 1.1 versus -0.3 ; 1.4 ; 95 % CI 0.2 to 2.7 ) and Hb A1C ( -1.2 % versus -0.4 % ) in the TExT-MED group .
RESULTS	The proportion of patients who used emergency services trended lower in the TExT-MED group ( 35.9 % versus 51.6 % ; 15.7 % ; 95 % CI 9.4 % to 22 % ) .
RESULTS	Overall , 93.6 % of respondents enjoyed TExT-MED and 100 % would recommend it to family/friends .
CONCLUSIONS	The TExT-MED program did not result in a statistically significant improvement in Hb A1C .
CONCLUSIONS	However , trends toward improvement in the primary outcome of Hb A1C and other secondary outcomes , including quality of life , were observed , the most pronounced being improved medication adherence .
CONCLUSIONS	TExT-MED also decreased ED utilization .
CONCLUSIONS	These findings were magnified in the Spanish-speaking subgroup .
CONCLUSIONS	Technologies such as TExT-MED represent highly scalable , low-cost , and widely accessible solutions for safety-net ED populations .

###24894077
BACKGROUND	Irritable bowel syndrome ( IBS ) and functional abdominal pain ( syndrome ) ( FAP ( S ) ) are common pediatric disorders , characterized by chronic or recurrent abdominal pain .
BACKGROUND	Treatment is challenging , especially in children with persisting symptoms .
BACKGROUND	Gut-directed hypnotherapy ( HT ) performed by a therapist has been shown to be effective in these children , but is still unavailable to many children due to costs , a lack of qualified child-hypnotherapists and because it requires a significant investment of time by child and parent ( s ) .
BACKGROUND	Home-based hypnotherapy by means of exercises on CD has been shown effective as well , and has potential benefits , such as lower costs and less time investment .
BACKGROUND	The aim of this randomized controlled trial ( RCT ) is to compare cost-effectiveness of individual HT performed by a qualified therapist with HT by means of CD recorded self-exercises at home in children with IBS or FAP ( S ) .
METHODS	260 children , aged 8-18 years with IBS or FAP ( S ) according to Rome III criteria are included in this currently conducted RCT with a follow-up period of one year .
METHODS	Children are randomized to either 6 sessions of individual HT given by a qualified therapist over a 3-month period or HT through self-exercises at home with CD for 3 months.The primary outcome is the proportion of patients in which treatment is successful at the end of treatment and after one year follow-up .
METHODS	Treatment success is defined as at least 50 % reduction in both abdominal pain frequency and intensity scores .
METHODS	Secondary outcomes include adequate relief , cost-effectiveness and effects of both therapies on depression and anxiety scores , somatization scores , QoL , pain beliefs and coping strategies .
CONCLUSIONS	If the effectiveness of home-based HT with CD is comparable to , or only slightly lower , than HT by a therapist , this treatment may become an attractive form of therapy in children with IBS or FAP ( S ) , because of its low costs and direct availability .
BACKGROUND	Dutch Trial Register number NTR2725 ( date of registration : 1 February 2011 ) .

###24395447
BACKGROUND	Cancer subtype has recently become an increasingly important consideration when deciding the treatment strategy for breast cancer .
BACKGROUND	For the estrogen receptor positive ( ER + ) subtype , the efficacy of adjuvant endocrine therapy is definitive , but that of adjuvant chemotherapy is controversial .
METHODS	In order to evaluate the effect of adding doxorubicin ( A ) and cyclophosphamide ( C ) to tamoxifen ( TAM ) ( ACT ) on the overall survival ( OS ) of node-positive postmenopausal breast cancer ( PMBC ) patients , we conducted a randomized trial .
METHODS	Eligibility criteria included pathologically node-positive ( n = 1-9 ) PMBC , stage I-IIIA disease .
METHODS	Patients were randomized to receive either TAM ( 20 mg daily ) for 2 years or A ( 40 mg/m ( 2 ) ) and C ( 500 mg/m ( 2 ) ) plus TAM ( ACT ) as adjuvant therapy following surgery .
RESULTS	One hundred twenty-nine patients were recruited ( TAM 64 , ACT 65 ) between October 1994 and July 1999 .
RESULTS	The hazard ratios for OS and relapse-free survival ( RFS ) were 0.58 ( 95 % CI 0.24-1 .39 ; log-rank p = 0.22 ) and 0.45 ( 95 % CI 0.24-0 .86 ; log-rank p = 0.013 ) , respectively , in favor of ACT .
RESULTS	The 5-year OS and RFS were 76.9 % ( ER + 87.1 % , ER - 53.3 % ) and 54.9 % ( ER + 59.3 % , ER - 42.9 % ) for TAM and 85.0 % ( ER + 90.0 % , ER - 77.1 % ) and 76.7 % ( ER + 76.9 % , ER - 76.0 % ) for ACT .
RESULTS	A higher proportion of the patients receiving ACT than those receiving TAM experienced grade 3 decreased white blood cell count and grade 2-3 nausea .
CONCLUSIONS	The efficacy of adding AC to TAM was not high for ER + , node-positive PMBC .
CONCLUSIONS	However , adjuvant ACT therapy was considered to be effective for ER - , node-positive PMBC .

###24564262
OBJECTIVE	We tested the impact of isolated systolic hypertension ( ISH ) on normalization of left ventricular ( LV ) structure during antihypertensive treatment .
METHODS	Baseline and annual echocardiograms were recorded in 873 hypertensive patients with electrocardiographic signs of LV hypertrophy during 4.8 years randomized losartan - or atenolol-based antihypertensive treatment in the Losartan Intervention For Endpoint ( LIFE ) reduction in hypertension study and classified as having ISH ( n = 128 ) if systolic BP 160 mmHg and diastolic BP < 90 mmHg , or non-ISH divided into two groups by systolic BP 160 mmHg ( non-ISH 160 mmHg ) ( n = 645 ) and systolic BP < 160 mm Hg ( n = 100 ) ( non-ISH < 160 mmHg ) , respectively .
RESULTS	Patients with ISH were older , with higher prevalence of diabetes than non-ISH groups and higher pulse pressure/stroke volume index ( all p < 0.05 ) .
RESULTS	Baseline systolic blood pressure ( BP ) differed between groups and was highest in the non-ISH 160 mmHg group ( p < 0.05 ) .
RESULTS	Systolic BP reduction was less in the ISH group ( p < 0.05 ) .
RESULTS	LV geometry did not differ between ISH and non-ISH 160 mmHg groups at baseline , but ISH had more residual LV hypertrophy of concentric type at the last study visit ( p < 0.05 ) .
RESULTS	In multivariate analysis , less reduction of LV mass was predicted by ISH ( = - 0.07 ) independent of significant associations with baseline LVMi ( = 0.52 ) and atenolol-based treatment ( = - 0.08 ) and clinical confounders ( all p < 0.05 ) .
CONCLUSIONS	ISH is associated with impaired normalization of LV mass during systematic antihypertensive treatment .
CONCLUSIONS	The findings may help explain the higher cardiovascular event rate previously reported in ISH patients .

###24499494
OBJECTIVE	This study aimed to assess the effects of a single dose of 10 mg NRL001 ( the 1R ,2 S stereoisomer of methoxamine hydrochloride ) in a 2 g suppository on pharmacodynamic and pharmacokinetic ( PK ) variables , and safety , in a healthy elderly population .
METHODS	This was a Phase I , single-centre , randomised , double-blind , placebo-controlled crossover study during which subjects received a single 2 g suppository of 10 mg NRL001 and a matching placebo in two separate treatment periods .
METHODS	The main outcome measures were Holter - , vital signs - and electrocardiogram-derived cardiovascular variables ; plasma PK analysis ; and safety assessments .
RESULTS	Twenty-six subjects were dosed with study medication .
RESULTS	Statistically significant reductions in Holter-derived heart rate ( HR ) , vital signs-derived HR and diastolic blood pressure ( BP ) were observed comparing NRL001 with placebo treatment , and also with increasing NRL001 plasma concentration .
RESULTS	No statistically significant relationships were observed between NRL001 concentration and systolic BP , mean arterial pressure or QTC interval ( both Bazett 's and Fridericia 's correction ) .
RESULTS	Thirty-nine adverse events were reported in 20 ( 76.9 % ) subjects , mostly after dosing with NRL001 .
CONCLUSIONS	Administration of NRL001 suppositories led to decreases in HR when compared with placebo data .
CONCLUSIONS	NRL001 was well tolerated with a good safety profile during the study .
CONCLUSIONS	Healthy elderly subjects did not show significantly different biological responses to NRL001 suppositories compared with younger healthy volunteers in previous studies .

###25034805
BACKGROUND	Green tea has become renowned for its health benefits .
BACKGROUND	In this study , we investigated the anti-stress effect of two kinds of green tea against a mental stress task load .
METHODS	Warm water , ordinary green tea ( Sagara ) , and shaded white tea , which contains more amino acid components than Sagara , were used as test samples in a randomized cross-over design study .
METHODS	Eighteen students ( nine male and nine female ) participated in three experimental trials on different days at intervals of seven days .
METHODS	Saliva was collected before beverage intake and after performing the mental stress load tasks .
METHODS	Concentration of chromogranin A ( CgA ) in the saliva was used as an index of autonomic nervous system activity .
RESULTS	CgA level increased after the mental tasks , but intake of green tea inhibited this increase ; the anti-stress effect was even greater after consumption of shaded white tea .
RESULTS	Intake of shaded white tea also lowered Total Mood Disturbance ( TMD ) score on the Profile of Mood States ( POMS ) ; subjects in this condition tended to perform more calculations in the arithmetic task than those in the warm water treatment condition .
CONCLUSIONS	Salivary CgA concentration levels increased after mental stress load tasks , but ingestion of green tea inhibited this increase .
CONCLUSIONS	This anti-stress effect was larger after the consumption of shaded white tea than after Sagara .
CONCLUSIONS	Shaded white tea intake also lowered TMD score ( POMS ) and tended to improve performance on an arithmetic task compared to warm water , suggesting that shaded white tea might also improve mood during and after mental stress load .

###25142870
OBJECTIVE	To determine if asthma control improves in patients who receive physician-pharmacist collaborative management ( PPCM ) during visits to primary care medical offices .
METHODS	Prospective pre-post study of patients who received the intervention in primary care offices for 9months .
METHODS	The primary outcome was the sum of asthma-related emergency department ( ED ) visits and hospitalizations at 9months before , 9months during , and 9months after the intervention .
METHODS	Events were analyzed using linear mixed-effects regression .
METHODS	Secondary analysis was conducted for patients with uncontrolled asthma ( Asthma Control Test [ ACT ] less than 20 ) .
METHODS	Additional secondary outcomes included the ACT , the Asthma Quality of Life Questionnaire by Marks ( AQLQ-M ) scores , and medication changes .
METHODS	Pharmacists provided patients with an asthma self-management plan and education and made pharmacotherapy recommendations to physicians when appropriate .
RESULTS	Of 126 patients , the number of emergency department ( ED ) visits and/or hospitalizations decreased 30 % during the intervention ( p = 0.052 ) and then returned to preenrollment levels after the intervention was discontinued ( p = 0.83 ) .
RESULTS	Secondary analysis of patients with uncontrolled asthma at baseline ( ACT less than 20 ) , showed 37 ED visits and hospitalizations before the intervention , 21 during the intervention , and 33 after the intervention was discontinued ( p = 0.019 ) .
RESULTS	ACT and AQLQ-M scores improved during the intervention ( ACT mean absolute increase of 2.11 , AQLQ-M mean absolute decrease of 4.86 , p < 0.0001 ) and sustained a stable effect after discontinuation of the intervention .
RESULTS	Inhaled corticosteroid use increased during the intervention ( p = 0.024 ) .
CONCLUSIONS	The PPCM care model reduced asthma-related ED visits and hospitalizations and improved asthma control and quality of life .
CONCLUSIONS	However , the primary outcome was not statistically significant for all patients .
CONCLUSIONS	There was a significant reduction in ED visits and hospitalizations during the intervention for patients with uncontrolled asthma at baseline .
CONCLUSIONS	Our findings support the need for further studies to investigate asthma outcomes achievable with the PPCM model .

###25267738
OBJECTIVE	We evaluated the role of residual vein thrombosis ( RVT ) to assess the optimal duration of anticoagulants in patients with cancer who have deep vein thrombosis ( DVT ) of the lower limbs .
METHODS	Patients with active cancer and a first episode of DVT treated with low molecular weight heparin ( LMWH ) for 6 months were eligible .
METHODS	Patients were managed according to RVT findings : those with RVT were randomly assigned to continue LMWH for an additional 6 months ( group A1 ) or to discontinue it ( group A2 ) , and patients without RVT stopped LMWH ( group B ) .
METHODS	The primary end point was recurrent venous thromboembolism ( VTE ) during the 1 year after disconinuation of LMWH , and the secondary end point was major bleeding .
METHODS	Analyses are from the time of random assignment .
RESULTS	Between October 2005 and April 2010 , 347 patients were enrolled .
RESULTS	RVT was detected in 242 patients ( 69.7 % ) ; recurrence occurred in 22 of the 119 patients in group A1compared with 27 of 123 patients in group A2 .
RESULTS	The adjusted hazard ratio ( HR ) for group A2 versus A1 was 1.37 ( 95 % CI , 0.7 to 2.5 ; P = .311 ) .
RESULTS	Three of the 105 patients in group B developed recurrent VTE ; adjusted HR for group A1 versus B was 6.0 ( 95 % CI , 1.7 to 21.2 ; P = .005 ) .
RESULTS	Three major bleeding events occurred in group A1 , and two events each occurred in groups A2 and B.
RESULTS	The HR for major bleeding in group A1 versus group A2 was 3.78 ( 95 % CI , 0.77 to 18.58 ; P = .102 ) .
RESULTS	Overall , 42 patients ( 12.1 % ) died during follow-up as a result of cancer progression .
CONCLUSIONS	In patients with cancer with a first DVT , treated for 6 months with LMWH , absence of RVT identifies a population at low risk for recurrent thrombotic events .
CONCLUSIONS	Continuation of LMWH in patients with RVT up to 1 year did not reduce recurrent VTE .

###25638248
BACKGROUND	Positive findings from the phase III MPACT trial led to the regulatory approval of nab-paclitaxel plus gemcitabine as a treatment option for patients with metastatic pancreatic cancer .
BACKGROUND	This report is an update of overall survival ( OS ) based on longer follow-up .
METHODS	Patients ( n = 861 ) with metastatic pancreatic cancer and a Karnofsky performance status of 70 or greater were randomly assigned one to one to receive nab-paclitaxel + gemcitabine or gemcitabine alone .
METHODS	Efficacy data for this post hoc analysis were collected through May 9 , 2013 .
METHODS	Exploratory analyses of carbohydrate antigen 19-9 ( CA19-9 ) and neutrophil-to-lymphocyte ratio ( NLR ) were conducted .
METHODS	The primary efficacy endpoint was OS , which was analyzed for all randomly assigned patients by the Kaplan-Meier method .
METHODS	All statistical tests were two-sided .
RESULTS	The median OS was statistically significantly longer for nab-paclitaxel plus gemcitabine vs gemcitabine alone ( 8.7 vs 6.6 months , hazard ratio [ HR ] = 0.72 , 95 % confidence interval [ CI ] = 0.62 to 0.83 , P < .001 ) .
RESULTS	Long-term ( > three-year ) survivors were identified in the nab-paclitaxel plus gemcitabine arm only ( 4 % ) .
RESULTS	In pooled treatment arm analyses , higher CA19-9 level and NLR at baseline were statistically significantly associated with worse OS .
RESULTS	There appeared to be a treatment effect for OS favoring nab-paclitaxel plus gemcitabine over gemcitabine alone in poor-prognosis subgroups defined by these factors ( HR = 0.612 , P < .001 for CA19-9 level median and HR = 0.81 , P = .079 for NLR > 5 ) .
CONCLUSIONS	These data confirm and extend the primary report of OS , supporting the superior efficacy of nab-paclitaxel plus gemcitabine over gemcitabine alone .
CONCLUSIONS	Subgroup analyses support the relevance of CA 19-9 and NLR as prognostic markers in metastatic pancreatic cancer .

###24989147
BACKGROUND	The role of social support in physical exercise is well documented .
BACKGROUND	However , the majority of studies that investigate the associations between social support and physical exercise target perceived instead of received social support .
BACKGROUND	Moreover , most studies investigate the effects of received social support using a descriptive correlational design .
BACKGROUND	Thus , our study aimed at investigating the effects of received social support by conducting an intervention study .
METHODS	Participants were randomly assigned to an intervention ( n = 118 ) or control group ( n = 102 ) .
METHODS	The intervention comprised regularly exercising with a new sports companion for eight weeks .
METHODS	To investigate the time course of physical exercise and received social support , growth curve modelling was employed .
RESULTS	Generally , both groups were able to improve their physical exercise .
RESULTS	However , the control group tended to decrease again during the final point of measurement .
RESULTS	Received social support , however , decreased slightly in the control group , but remained stable in the intervention group .
CONCLUSIONS	The intervention was suitable to sustain received social support for physical exercise across a two-month interval .
CONCLUSIONS	Overall , these findings highlight the importance of further investigating social support for physical exercise applying an experimental approach .

###25487027
OBJECTIVE	To compare treatment with preservative-free and preserved sodium hyaluronate 0.1 % and fluorometholone 0.1 % eyedrops after cataract surgery in patients with preexisting dry-eye syndrome .
METHODS	Bucheon St. Mary 's Hospital , Catholic University of Korea , Seoul , Korea .
METHODS	Randomized controlled study .
METHODS	Patients with cataract and dry-eye syndrome were randomly divided into 2 groups .
METHODS	Group 1 patients were treated with preservative-free sodium hyaluronate 0.1 % and preservative-free fluorometholone 0.1 % eyedrops 4 times a day in the first month and twice a day in the second month .
METHODS	Group 2 patients were treated with preserved eyedrops using the same schedule .
METHODS	Ocular Surface Disease Index ( OSDI ) score , tear-film breakup time ( TBUT ) , Schirmer I test , corneal fluorescein staining , impression cytology , and antioxidant and inflammatory cytokine activities in tears were evaluated .
RESULTS	Both groups comprised 40 patients .
RESULTS	At 2 months , the OSDI score , TBUT , Schirmer I score , fluorescein staining score , impression cytology findings , and goblet cell count were significantly better in Group 1 than in Group 2 ( P < .05 ) .
RESULTS	The interleukin-1 and tumor necrosis factor - concentrations were significantly less in the tears of Group 1 patients than in the tears of Group 2 patients , and catalase and superoxide dismutase 2 fluorescence intensities were significantly greater in the tears of Group 1 patients than in the tears of Group 2 patients ( P < .05 ) .
CONCLUSIONS	Preservative-free sodium hyaluronate 0.1 % and fluorometholone 0.1 % eyedrops can improve the symptoms and signs of dry-eye syndrome after cataract surgery .
CONCLUSIONS	Preservative-free fluorometholone eyedrops may have antiinflammatory and antioxidant effects in tears of patients with dry-eye syndrome .
BACKGROUND	No author has a financial or proprietary interest in any material or method mentioned .

###25264121
OBJECTIVE	To study the effect of a synthetic medium and compare it with a serum-based medium for corneal preservation in organ culture using an overall quality assessment system .
METHODS	A randomized study with blinded observers was performed comparing parameters such as thickness , transparency , viable endothelial cell density ( VECD ) , morphology , and overall quality ( OQ ) of the corneal tissues preserved in synthetic and a serum-based medium , respectively .
METHODS	Seven human paired corneas were randomly selected and assessed at day 0 ( initial ) , day 2 ( before organ culture ) , day 30 ( before deturgescence/deswelling storage ) , and 48 hours post deswelling .
METHODS	Thickness was determined with optical coherence tomography and transparency with a validated , custom device .
METHODS	The morphology and VECD were observed after treating the tissues with trypan blue and sucrose .
METHODS	Data were compared using paired t tests with p < 0.05 deemed significant .
RESULTS	Parameters were similar at the initial stage between the groups with no statistically significant difference .
RESULTS	However , after preservation in the deturgescent medium , the corneas stored in a serum-based medium showed a higher and statistically significant OQ value ( p = 0.0317 ) .
CONCLUSIONS	The OQ of a serum-based medium was higher than that of the synthetic medium .
CONCLUSIONS	A higher rate of transparency and reduction in thickness was observed in the serum-based medium at the end of the storage .
CONCLUSIONS	Although complete synthetic media may have distinct advantages of being serum/animal-free , the quality of the cornea is of a reasonable concern when it is deemed for transplantation .

###24930169
OBJECTIVE	Assess team performance within a net-worked supervisory control setting while manipulating automated decision aids and monitoring team communication and working memory ability .
BACKGROUND	Networked systems such as multi-unmanned air vehicle ( UAV ) supervision have complex properties that make prediction of human-system performance difficult .
BACKGROUND	Automated decision aid can provide valuable information to operators , individual abilities can limit or facilitate team performance , and team communication patterns can alter how effectively individuals work together .
BACKGROUND	We hypothesized that reliable automation , higher working memory capacity , and increased communication rates of task-relevant information would offset performance decrements attributed to high task load .
METHODS	Two-person teams performed a simulated air defense task with two levels of task load and three levels of automated aid reliability .
METHODS	Teams communicated and received decision aid messages via chat window text messages .
RESULTS	Task Load x Automation effects were significant across all performance measures .
RESULTS	Reliable automation limited the decline in team performance with increasing task load .
RESULTS	Average team spatial working memory was a stronger predictor than other measures of team working memory .
RESULTS	Frequency of team rapport and enemy location communications positively related to team performance , and word count was negatively related to team performance .
CONCLUSIONS	Reliable decision aiding mitigated team performance decline during increased task load during multi-UAV supervisory control .
CONCLUSIONS	Team spatial working memory , communication of spatial information , and team rapport predicted team success .
CONCLUSIONS	An automated decision aid can improve team performance under high task load .
CONCLUSIONS	Assessment of spatial working memory and the communication of task-relevant information can help in operator and team selection in supervisory control systems .

###25092937
OBJECTIVE	High-fidelity simulation is an effective tool in teaching neonatal resuscitation skills to professionals .
OBJECTIVE	We aimed to determine whether in situ simulation training ( for 80 % of the delivery room staff ) improved neonatal resuscitation performed by the staff at maternities .
METHODS	A baseline evaluation of 12 maternities was performed : a random sample of 10 professionals in each unit was presented with 2 standardized scenarios played on a neonatal high-fidelity simulator .
METHODS	The medical procedures were video recorded for later assessments .
METHODS	The 12 maternities were then randomly assigned to receive the intervention ( a 4-hour simulation training session delivered in situ for multidisciplinary groups of 6 professionals ) or not receive it .
METHODS	All maternities were evaluated again at 3 months after the intervention .
METHODS	The videos were assessed by 2 neonatologists blinded to the pre - / postintervention as well as to the intervention/control groups .
METHODS	The performance was assessed using a technical score and a team score .
RESULTS	After intervention , the median technical score was significantly higher for scenarios 1 and 2 for the intervention group compared with the control group ( P = .01 and 0.004 , respectively ) , the median team score was significantly higher ( P < .001 ) for both scenarios .
RESULTS	In the intervention group , the frequency of achieving a heart rate > 90 per minute at 3 minutes improved significantly ( P = .003 ) , and the number of hazardous events decreased significantly ( P < .001 ) .
CONCLUSIONS	In situ simulation training with multidisciplinary teams can effectively improve technical skills and teamwork in neonatal resuscitation .

###25431431
BACKGROUND	Dementia with Lewy bodies ( DLB ) is underrecognised in clinical settings .
OBJECTIVE	To investigate whether performing a ( 123 ) I-ioflupane injection ( ( 123 ) I-FP-CIT also called DaTSCAN ) single photon emission computed tomography ( SPECT ) scan in patients with possible DLB would lead to a more certain diagnosis ( probable DLB or non-DLB dementia ) .
METHODS	We randomised 187 patients with possible DLB 2:1 to have a scan or not ( control group ) .
METHODS	The outcome measure was a change in diagnosis to probable DLB or non-DLB .
RESULTS	There were 56 controls and 114 scanned patients , of whom 43 % had an abnormal scan .
RESULTS	More patients in the imaging group had a change in diagnosis compared with controls at 8 and 24 weeks ( 61 % ( n = 70 ) v. 4 % ( n = 2 ) and 71 % ( n = 77 ) v. 16 % ( n = 9 ) ; both P < 0.0001 ) .
RESULTS	Clinicians were more likely to change the diagnosis if the scan was abnormal ( 82 % ) than if it was normal ( 46 % ) .
CONCLUSIONS	Imaging significantly contributed to a more certain diagnosis , proving to be a useful adjunct in the work-up of patients with possible DLB .

###24847853
BACKGROUND	Protein is indispensable in the human diet , and its intake appears tightly regulated .
BACKGROUND	The role of sensory attributes of foods in protein intake regulation is far from clear .
OBJECTIVE	We investigated the effect of human protein status on neural responses to different food cues with the use of functional magnetic resonance imaging ( fMRI ) .
OBJECTIVE	The food cues varied by taste category ( sweet compared with savory ) and protein content ( low compared with high ) .
OBJECTIVE	In addition , food preferences and intakes were measured .
METHODS	We used a randomized crossover design whereby 23 healthy women [ mean SD age : 22 2 y ; mean SD body mass index ( in kg/m ( 2 ) ) : 22.5 1.8 ] followed two 16-d fully controlled dietary interventions involving consumption of either a low-protein diet ( 0.6 g protein kg body weight ( -1 ) d ( -1 ) , ~ 7 % of energy derived from protein , approximately half the normal protein intake ) or a high-protein diet ( 2.2 g protein kg body weight ( -1 ) d ( -1 ) , ~ 25 % of energy , approximately twice the normal intake ) .
METHODS	On the last day of the interventions , blood oxygen level-dependent ( BOLD ) responses to odor and visual food cues were measured by using fMRI .
METHODS	The 2 interventions were followed by a 1-d ad libitum phase , during which a large array of food items was available and preference and intake were measured .
RESULTS	When exposed to food cues ( relative to the control condition ) , the BOLD response was higher in reward-related areas ( orbitofrontal cortex , striatum ) in a low-protein state than in a high-protein state .
RESULTS	Specifically , BOLD was higher in the inferior orbitofrontal cortex in response to savory food cues .
RESULTS	In contrast , the protein content of the food cues did not modulate the BOLD response .
RESULTS	A low protein state also increased preferences for savory food cues and increased protein intake in the ad libitum phase as compared with a high-protein state .
CONCLUSIONS	Protein status modulates brain responses in reward regions to savory food cues .
CONCLUSIONS	These novel findings suggest that dietary protein status affects taste category preferences , which could play an important role in the regulation of protein intake in humans .
CONCLUSIONS	This trial was registered at www.trialregister.nl/trialreg/admin/rctview.asp?TC=3288 as NTR3288 .

###24583632
BACKGROUND	WEB-Based Distress Management Program for Implantable CARdioverter defibrillator Patients ( WEBCARE ) is a Web-based randomized controlled trial , designed to improve psychological well-being in patients with an implantable cardioverter defibrillator ( ICD ) .
BACKGROUND	As in other Web-based trials , we encountered problems with attrition and adherence .
OBJECTIVE	In the current study , we focus on the patient characteristics , reasons , and motivation of ( 1 ) completers , ( 2 ) those who quit the intervention , and ( 3 ) those who quit the intervention and the study in the treatment arm of WEBCARE .
METHODS	Consecutive first-time ICD patients from six Dutch referral hospitals were approached for participation .
METHODS	After signing consent and filling in baseline measures , patients were randomized to either the WEBCARE group or the Usual Care group .
RESULTS	The treatment arm of WEBCARE contained 146 patients .
RESULTS	Of these 146 , 34 ( 23.3 % ) completed the treatment , 88 ( 60.3 % ) dropped out of treatment but completed follow-up , and 24 ( 16.4 % ) dropped out of treatment and study .
RESULTS	Results show no systematic differences in baseline demographic , clinical , or psychological characteristics between groups .
RESULTS	A gradual increase in dropout was observed with 83.5 % ( 122/146 ) completing the first lesson , while only 23.3 % ( 34/146 ) eventually completed the whole treatment .
RESULTS	Reasons most often given by patients for dropout were technical problems with the computer , time constraints , feeling fine , and not needing additional support .
CONCLUSIONS	Current findings underline the importance of focusing on adherence and dropout , as this remains a significant problem in behavioral Web-based trials .
CONCLUSIONS	Examining possibilities to address barriers indicated by patients might enhance treatment engagement and improve patient outcomes .
BACKGROUND	Clinicaltrials.gov : NCT00895700 ; http://www.clinicaltrials.gov/ct2/show/NCT00895700 ( Archived by WebCite at http://www.webcitation.org/6NCop6Htz ) .

###24878457
BACKGROUND	We previously conducted a randomized , clinical trial comparing early appendectomy with interval appendectomy for perforated appendicitis .
BACKGROUND	The purpose of the present study was to evaluate the effect this clinical trial had on subsequent practice patterns and outcomes for patients with perforated appendicitis at the free-standing children 's hospital conducting the trial .
METHODS	A retrospective study was conducted comparing children with perforated appendicitis treated before the trial ( 2005-2006 ) and after the trial ( 2009-2011 ) .
METHODS	Early appendectomy was performed within 24 hours of diagnosis ; interval appendectomy occurred 4-6 weeks after initial treatment with antibiotics .
METHODS	Patient characteristics , treatment variables , and outcomes were collected and compared .
RESULTS	The pretrial group consisted of 92 patients-62 ( 67 % ) underwent early appendectomy , and 30 ( 33 % ) patients had interval appendectomy .
RESULTS	The posttrial group was composed of 103 patients , with 87 ( 84 % ) undergoing early appendectomy and 16 ( 16 % ) interval appendectomy ( P = .005 ) .
RESULTS	The groups were similar in patient and admission characteristics , although the posttrial group had a lower percentage of self-pay patients and fewer computed tomography scans ; health care use was similar between groups .
RESULTS	Overall , the posttrial group had fewer adverse events ( 18 % vs 34 % , P = .02 ) , specifically fewer wound infections ( 2 % vs 14 % , P = .001 ) and fewer unplanned readmissions ( 7 % vs 16 % , P = .04 ) than the pretrial group .
RESULTS	In the posttrial group , those patients selected for interval appendectomy were more likely to complete the planned course of therapy than in the pretrial group .
CONCLUSIONS	A clinical trial conducted at our institution to evaluate currently available treatment options for perforated appendicitis did change practice patterns at our hospital .
CONCLUSIONS	After the trial , there was an increase in the use of early appendectomy , a decrease in the number of computed tomography scans performed per patient , and a reduction in the overall adverse event rate .

###24261022
OBJECTIVE	To compare responses to therapy of Black African ( BA ) and non-Black African ( non - BA ) patients with hepatitis C virus genotype 4 ( HCV-4 ) residing in Belgium .
METHODS	In this retrospective multicenter study , 473 patients with HCV-4 were selected from databases at 7 Belgian centers ; 209 treatment-naive patients ( 154 BA ) had received treatment with peg-interferon ( peg-IFN ) plus ribavirin ( RBV ) and were included in the study .
RESULTS	There was a greater percentage of female patients in the BA group than in the non - BA group ; BA patients were also older , had a greater body mass index , and more frequently had abnormal glucose metabolism .
RESULTS	The route of contamination was more frequently unknown in BA than in non-BA patients and BA patients had more HCV-4 subtypes .
RESULTS	There were no differences in other demographic factors between the groups .
RESULTS	Sustained viral response ( SVR ) and complete early viral response rates were significantly lower and relapse rates significantly higher in BA than in non-BA patients .
RESULTS	There were no differences between groups in rates of dose modification or in drug tolerance .
CONCLUSIONS	In our cohort , treatment-naive BA patients with HCV-4 who were treated with peg-IFN and ribavirin had a much lower SVR rate than treatment-naive non-BA patients with HCV-4 who were treated with peg-IFN and ribavirin , and a higher relapse rate , possibly related to a weaker response to interferon-based therapy .
CONCLUSIONS	Treatment may need to be adapted in this population .

###25257359
BACKGROUND	Vitamin D receptors have been identified in the spinal cord , nerve roots , dorsal root ganglia and glial cells , and its genetic polymorphism association with the development of lumbar disc degeneration and herniation has been documented .
BACKGROUND	Metabolic effects of active vitamin D metabolites in the nucleus pulposus and annulus fibrosus cells have been studied .
BACKGROUND	Lumbar disc herniation is a process that involves immune and inflammatory cells and processes that are targets for immune regulatory actions of vitamin D as a neurosteroid hormone .
BACKGROUND	In addition to vitamin D 's immune modulatory properties , its receptors have been identified in skeletal muscles .
BACKGROUND	It also affects sensory neurons to modulate pain .
BACKGROUND	In this study , we aim to study the role of vitamin D3 in discogenic pain and related sensory deficits .
BACKGROUND	Additionally , we will address how post-treatment 25-hydroxy vitamin D3 level influences pain and sensory deficits severity .
BACKGROUND	The cut-off value for serum 25-hydroxy vitamin D3 that would be efficacious in improving pain and sensory deficits in lumbar disc herniation will also be studied .
METHODS	We will conduct a randomized , placebo-controlled , double-blind clinical trial .
METHODS	Our study population will include 380 cases with one-level and unilateral lumbar disc herniation with duration of discogenic pain less than 8 weeks .
METHODS	Individuals who do not have any contraindications , will be divided into three groups based on serum 25-hydroxy vitamin D3 level , and each group will be randomized to receive either a single-dose 300,000-IU intramuscular injection of vitamin D3 or placebo .
METHODS	All patients will be under conservative treatment .
METHODS	Pre-treatment and post-treatment assessments will be performed with the McGill Pain Questionnaire and a visual analogue scale .
METHODS	For the 15-day duration of this study , questionnaires will be filled out during telephone interviews every 3 days ( a total of five times ) .
METHODS	The initial and final interviews will be scheduled at our clinic .
METHODS	After 15 days , serum 25-hydroxy vitamin D3 levels will be measured for those who have received vitamin D3 ( 190 individuals ) .
BACKGROUND	Iranian Registry for Clinical Trials ID : IRCT2014050317534N1 ( trial registration : 5 June 2014 ) .

###24227683
BACKGROUND	In foot and ankle surgery , there are multiple sites used for autologous bone graft , including the proximal ( PT ) or distal tibia ( DT ) , calcaneus ( C ) , and iliac crest ( ICBG ) .
BACKGROUND	There has been no comparison between these anatomic areas and the potential for acute or persistent pain at 1 year .
BACKGROUND	The purpose of this study was to prospectively compare patient-reported outcomes of acute and persistent pain at 1 year after surgery to determine if harvest site selection made a difference .
METHODS	As part of a clinical trial examining ankle and hindfoot fusion rates with autograft compared with synthetic graft , the autologous bone graft harvest sites were assessed with visual analog pain outcome scores at 3 , 24 , 36 , and 52 weeks after surgery .
METHODS	Patients with a score of 20 + defined clinically significant pain .
METHODS	Four harvest sites were compared : ICBG , PT , DT , and C. Fisher exact test was used to compare the graft site pain between locations .
RESULTS	Twelve percent of subjects reported clinically significant pain at 24 weeks and 8.5 % at 52 weeks postoperatively .
RESULTS	Each lower extremity harvest site ( C , DT , PT ) showed higher rates of clinically significant graft harvest site pain than the ICBG at 52 weeks .
CONCLUSIONS	Autologous bone graft harvest carried a risk of persistent pain at up to 1 year ( weeks 24-52 ) in 18 % of patients .
CONCLUSIONS	Lower-extremity bone graft sites had the greatest risk for persistent pain at 1 year .
METHODS	Level II , prospective comparative study .

###25828038
BACKGROUND	Dermal fillers are commonly injected in the lips for aesthetic treatment .
BACKGROUND	Small gel particle hyaluronic acid ( SGP-HA ) is the only filler approved by the US Food and Drug Administration for this indication , based on a pivotal trial of effectiveness and safety .
OBJECTIVE	To assess multiple measures of tolerability and lip function in a randomized controlled trial of SGP-HA ( without lidocaine ) for lip augmentation .
METHODS	Patients were randomized to SGP-HA ( n = 135 ) or no treatment ( n = 45 ) at baseline ; all could receive SGP-HA after 6 months .
METHODS	Assessments for tolerability and lip function at clinic visits throughout the study included lip texture , firmness , symmetry , movement , function , and sensation ; device palpability ; mass formation ; and ease of repeat injection .
RESULTS	Many assessments were normal ( lip function , sensation ) or unremarkable ( movement , mass formation , ease of reinjection ) in most patients .
RESULTS	Nearly all abnormalities with other assessments ( texture , firmness , symmetry , device palpability ) were mild and transient ( < 4 weeks ) .
CONCLUSIONS	Lip augmentation with SGP-HA showed excellent safety with the assessments used in this study .
CONCLUSIONS	Further study should be conducted to validate these assessments with the goal of developing a comprehensive scale for measuring potential functional complications and risks .

###24518370
OBJECTIVE	To examine the impact of dehydration , ethnicity , and gender on urinary concentrations of salbutamol in relation to the threshold stipulated by the World Anti-Doping Agency ( WADA ) .
METHODS	Repeated measures open-label .
METHODS	Eighteen male and 14 female athletes ( 9 white males , 9 white females , 2 Afro-Caribbean males , 2 Afro-Caribbean females , 6 Asian [ Indian subcontinent ] males , and 4 Asian females ) were recruited .
METHODS	All participants were nonasthmatic .
METHODS	After inhalation of 800 g or 1600 g of salbutamol , athletes exercised in a hot controlled environment ( 35C , 40 % relative humidity ) at a self-selected pace until a target weight loss ( 2 % or 5 % ) was achieved .
METHODS	Urine concentration of free salbutamol .
RESULTS	After inhalation of 1600 g salbutamol , 20 participants presented with a urine salbutamol concentrations above the current WADA limit ( 1000 ng/mL ) and decision limit ( 1200 ng/mL ) resulting in an adverse analytical finding .
RESULTS	There were no differences according to gender or ethnic origin .
CONCLUSIONS	Dehydration equivalent to a body mass loss greater than 2 % concomitant to the acute inhalation of 1600 g of salbutamol may result in a urine concentration above the current WADA limit and decision limit leading to a positive test finding independent of gender or ethnic origin .
CONCLUSIONS	Asthmatic athletes using salbutamol should receive clear dosing advise and education to minimize the risk of inhaling doses of salbutamol that may produce urine concentrations of salbutamol above 1200 ng/mL .

###24518285
OBJECTIVE	To investigate the efficacy of fesoterodine vs placebo on nocturia , sleep disturbance , and sleep-related quality of life ( QoL ) in patients with overactive bladder and nocturia .
METHODS	This posthoc analysis used data from a 12-week , randomized , placebo-controlled trial of fesoterodine 4 and 8 mg per day in Asian adults reporting 8 micturitions and 1 urgency urinary incontinence episodes per 24 hours at baseline .
METHODS	Patients who reported 1 nocturnal micturition/24 h were included in this analysis .
METHODS	Efficacy variables included change from baseline to week 12/end of treatment in nocturnal micturitions/24 h , nocturnal voided volume/micturition , and hours of undisturbed sleep .
METHODS	Sleep-related QoL was assessed using King 's Health Questionnaire Sleep/Energy domain .
METHODS	Treatment comparisons were made using analysis of covariance .
RESULTS	Among 555 patients , reductions in nocturnal micturitions with fesoterodine 4 mg ( -0.63 ) and 8 mg ( -0.77 ) were numerically greater vs placebo ( -0.56 ) , but differences were not significant ( P > .05 ) .
RESULTS	When patients with a nocturnal polyuria index > 33 % were excluded , the decrease in nocturnal micturitions was significantly greater with fesoterodine 8 mg vs placebo ( -0.24 ; P = .031 ) .
RESULTS	Increases in nocturnal voided volume/micturition were significantly greater with fesoterodine 4 ( 38.07 mL ; P = .013 ) and 8 mg ( 42.05 mL ; P < .001 ) vs placebo ( 14.89 mL ) .
RESULTS	Hours of undisturbed sleep was significantly longer with fesoterodine 4 mg vs placebo ( 80 vs 54 minutes ; P = .032 ) ; improvement in King 's Health Questionnaire Sleep/Energy scores was significantly greater with fesoterodine 4 ( P = .034 ) and 8 mg ( P = .019 ) vs placebo .
CONCLUSIONS	These results suggest that fesoterodine may reduce nocturnal micturitions and improve sleep quality and QoL in overactive bladder patients with nocturia .

###24563240
OBJECTIVE	Due to the gap in suicide-specific intervention training for mental health students and professionals , e-learning is one solution to improving provider skills in the Veterans Affairs ( VA ) health system .
OBJECTIVE	This study focused on the development and evaluation of an equivalent e-learning alternative to the Collaborative Assessment and Management of Suicidality ( CAMS ) in-person training approach at a Veteran Health Affairs medical center .
METHODS	The study used a multicenter , randomized , cluster , and three group design .
METHODS	the development of e-CAMS was an iterative process and included pilot testing .
METHODS	Eligible and consenting mental health providers , who completed a CAMS pre-survey , were randomized .
METHODS	Provider satisfaction was assessed using the standard VA evaluation of training consisting of 20 items .
METHODS	Two post training focus groups , divided by learning conditions , were conducted to assess practice adoption using a protocol focused on experiences with training and delivery of CAMS .
RESULTS	A total of 215 providers in five sites were randomized to three conditions : 69 to e-learning , 70 to in-person , 76 to the control .
RESULTS	The providers were primarily female , Caucasian , midlife providers .
RESULTS	Based on frequency scores of satisfaction items , both learning groups rated the trainings positively .
RESULTS	In focus groups representing divided by learning conditions , participants described positive reactions to CAMS training and similar individual and institutional barriers to full implementation of CAMS .
CONCLUSIONS	This is the first evaluation study of a suicide-specific e-learning training within the VA. .
CONCLUSIONS	The e-CAMS appears equivalent to the in-person CAMS in terms of provider satisfaction with training and practice adoption , consistent with other comparisons of training deliveries across specialty areas .
CONCLUSIONS	Additional evaluation of provider confidence and adoption and patient outcomes is in progress .
CONCLUSIONS	The e-CAMS has the potential to provide ongoing training for VA and military mental health providers and serve as a tutorial for psychiatrists in preparation for specialty boards .

###24837707
BACKGROUND	The safety of exercise-based cardiac rehabilitation ( CR ) has not been investigated in Japan , so a nationwide survey was conducted to investigate the incidence of adverse events ( AEs ) associated with CR and exercise testing .
RESULTS	In total , 136 hospitals reported operating recovery-phase CR programs , amounting to 383,096 patient-hours of exercise training .
RESULTS	The incidence rates of all AEs and life-threatening AEs ( LAE : death , cardiac arrest , acute myocardial infarction , cardiac rupture ) during exercise sessions were 12 and 1 event/383 ,096 patient-hours ( 3.13 and 0.26 events/100 ,000 patient-hours ) , respectively .
RESULTS	When CR programs were categorized as `` Formal '' in which an exercise prescription based on exercise testing was issued to individual patients or `` Non-formal '' without exercise prescription , the incidence of AEs during and within the 24 h after an exercise session was significantly lower in the Formal than the Non-formal CR programs ( P < 0.001 ) , despite similar hospital size and coronary intervention volumes between the 2 category hospitals .
RESULTS	Moreover , LAEs did not occur in 277,721 patient-hours in Formal CR , whereas 2 LAEs occurred in 105,375 patient-hours in Non-formal CR ( P < 0.05 ) .
RESULTS	During 469,215 exercise testing sessions , 3 LAEs ( 0.64 event/100 ,000 tests ) and 31 non-LAEs ( 6.61 events/100 ,000 tests ) occurred .
CONCLUSIONS	This first nationwide survey in Japan revealed that both exercise-based CR and exercise testing are generally safe , and that Formal CR , in which an individual exercise prescription is determined by exercise testing , is particularly safe .

###24508782
OBJECTIVE	To compare the safety and efficacy of the two single-tablet regimens ( STRs ) , rilpivirine/emtricitabine/tenofovir disoproxil fumarate ( RPV/FTC/TDF ) and efavirenz/emtricitabine/tenofovir DF ( EFV/FTC/TDF ) , in HIV-1-infected , treatment-naive adults .
METHODS	This is a phase 3b , randomized , open-label , multicenter , international , 96-week study .
METHODS	Participants were randomized 1:1 to receive either RPV/FTC/TDF or EFV/FTC/TDF .
METHODS	The primary endpoint was the proportion of participants with HIV-1 RNA less than 50 copies/ml at week 48 by the Snapshot algorithm .
RESULTS	A total of 786 participants were randomized .
RESULTS	RPV/FTC/TDF was noninferior to EFV/FTC/TDF ( 85.8 vs. 81.6 % ) at week 48 for HIV-1 RNA less than 50 copies/ml [ difference 4.1 % , 95 % confidence interval ( CI ) -1.1 to 9.2 % ] .
RESULTS	A statistically significant difference in efficacy favoring RPV/FTC/TDF was demonstrated for participants with baseline HIV-1 RNA 100000 copies/ml or less [ ( n = 510 ) 88.8 % RPV/FTC/TDF vs. 81.6 % EFV/FTC/TDF ( difference 7.2 % , 95 % CI 1.1-13 .4 % ) ] .
RESULTS	In participants with baseline HIV-1 RNA more than 100000 copies/ml ( n = 276 ) , RPV/FTC/TDF demonstrated noninferior efficacy compared with EFV/FTC/TDF ( 79.9 vs. 81.7 % , respectively , difference -1.8 % , 95 % CI -11.1 to 7.5 % ) .
RESULTS	In the RPV/FTC/TDF arm , more virologic failure was observed as baseline HIV-1 RNA levels increased .
RESULTS	There were more participants with emergent resistance in the RPV/FTC/TDF arm than in the EFV/FTC/TDF arm ( 4 vs. 1 % , respectively ) .
RESULTS	There were fewer discontinuations because of adverse events with RPV/FTC/TDF ( 2.5 % ) than with EFV/FTC/TDF ( 8.7 % ) .
CONCLUSIONS	In treatment-naive participants , RPV/FTC/TDF demonstrated noninferior efficacy and improved tolerability compared with EFV/FTC/TDF , as well as a statistically significant difference in efficacy for participants with baseline HIV-1 RNA 100000 copies/ml or less at week 48 .

###25775048
OBJECTIVE	Indwelling devices ( eg , urinary catheters and feeding tubes ) are often used in nursing homes ( NHs ) .
OBJECTIVE	Inadequate care of residents with these devices contributes to high rates of multidrug-resistant organisms ( MDROs ) and device-related infections in NHs .
OBJECTIVE	To test whether a multimodal targeted infection program ( TIP ) reduces the prevalence of MDROs and incident device-related infections .
METHODS	Randomized clinical trial at 12 community-based NHs from May 2010 to April 2013 .
METHODS	Participants were high-risk NH residents with urinary catheters , feeding tubes , or both .
METHODS	Multimodal , including preemptive barrier precautions , active surveillance for MDROs and infections , and NH staff education .
METHODS	The primary outcome was the prevalence density rate of MDROs , defined as the total number of MDROs isolated per visit averaged over the duration of a resident 's participation .
METHODS	Secondary outcomes included new MDRO acquisitions and new clinically defined device-associated infections .
METHODS	Data were analyzed using a mixed-effects multilevel Poisson regression model ( primary outcome ) and a Cox proportional hazards model ( secondary outcome ) , adjusting for facility-level clustering and resident-level variables .
RESULTS	In total , 418 NH residents with indwelling devices were enrolled , with 34,174 device-days and 6557 anatomic sites sampled .
RESULTS	Intervention NHs had a decrease in the overall MDRO prevalence density ( rate ratio , 0.77 ; 95 % CI , 0.62-0 .94 ) .
RESULTS	The rate of new methicillin-resistant Staphylococcus aureus acquisitions was lower in the intervention group than in the control group ( rate ratio , 0.78 ; 95 % CI , 0.64-0 .96 ) .
RESULTS	Hazard ratios for the first and all ( including recurrent ) clinically defined catheter-associated urinary tract infections were 0.54 ( 95 % CI , 0.30-0 .97 ) and 0.69 ( 95 % CI , 0.49-0 .99 ) , respectively , in the intervention group and the control group .
RESULTS	There were no reductions in new vancomycin-resistant enterococci or resistant gram-negative bacilli acquisitions or in new feeding tube-associated pneumonias or skin and soft-tissue infections .
CONCLUSIONS	Our multimodal TIP intervention reduced the overall MDRO prevalence density , new methicillin-resistant S aureus acquisitions , and clinically defined catheter-associated urinary tract infection rates in high-risk NH residents with indwelling devices .
CONCLUSIONS	Further studies are needed to evaluate the cost-effectiveness of this approach as well as its effects on the reduction of MDRO transmission to other residents , on the environment , and on referring hospitals .
BACKGROUND	clinicaltrials.gov Identifier : NCT01062841 .

###24899762
OBJECTIVE	To assess the time-dependent effect of continuous positive airway pressure ( CPAP ) , on insulin-like growth factor-1 ( IGF-1 ) , IGF binding proteins ( IGFBPs ) and pulsatile growth hormone ( GH ) secretion .
METHODS	A randomized , double-blind , sham-controlled , parallel group study .
METHODS	Sixty-five middle-aged men with moderate to severe obstructive sleep apnea .
METHODS	Active ( n = 34 ) or sham ( n = 31 ) CPAP for 12 weeks , followed by 12 weeks of active CPAP ( n = 65 ) .
RESULTS	Fasting morning IGF-1 , IGFBP-3 , and IGFBP-1 blood levels at 0 , 6 , 12 , and 24 weeks .
RESULTS	Overnight GH secretion was calculated by mathematical deconvolution of serial GH measurements from serum samples collected every 10 min ( 22:00 -06:00 ) during simultaneous polysomnography in a subset of 18 men ( active n = 11 , sham n = 7 ) at week 12 .
RESULTS	Active , compared with sham , CPAP increased IGF-1 at 12 weeks ( P = 0.006 ) , but not at 6 weeks ( P = 0.44 ) .
RESULTS	Changes in IGFBP-3 and IGFBP-1 were not different between groups at 6 or 12 weeks ( all P 0.15 ) .
RESULTS	At week 24 , there was a further increase in IGF-1 and a decrease in IGFBP-1 in the pooled group ( P = 0.0001 and 0.046 , respectively ) .
RESULTS	In the subset , total ( P = 0.001 ) and pulsatile ( P = 0.002 ) GH secretion , mean GH concentration ( P = 0.002 ) , mass of GH secreted per pulse ( P = 0.01 ) and pulse frequency ( P = 0.04 ) were all higher after 12 weeks of CPAP compared with sham .
RESULTS	Basal secretion , interpulse regularity , and GH regularity were not different between groups ( all P > 0.11 ) .
CONCLUSIONS	Twelve weeks , but not 6 weeks , of CPAP increases IGF-1 , with a further increase after 24 weeks .
CONCLUSIONS	Total and pulsatile GH secretion , secretory burst mass and pulse frequency are also increased by 12 weeks .
CONCLUSIONS	CPAP improves specific elements of the GH/IGF -1 axis in a time-dependent manner .
BACKGROUND	Australia New Zealand Clinical Trials Network , www.anzctr.org.au , number ACTRN12608000301369 .

###24488424
OBJECTIVE	Assessment of structural damage of sacroiliac joints ( SIJ ) in patients with axial spondyloarthritides ( axSpA ) has been discussed as a useful outcome measure in clinical trials .
OBJECTIVE	The aim of our study was to evaluate different magnetic resonance imaging ( MRI ) scoring methods and pulse sequences with a focus on fatty lesions and bony erosions .
METHODS	Seventy-five patients with the diagnosis of axSpA underwent MRI at 3 timepoints as part of the ESTHER trial , which compared 2 groups of patients treated with etanercept or sulfasalazine .
METHODS	Two MRI sequences [ unenhanced T1-weighted ( T1w ) turbo spin-echo ( TSE ) and unenhanced T1w opposed-phase gradient-echo sequences ( opGRE ) ] and 2 different scoring systems ( simple and comprehensive Berlin method ) were used for the evaluation of fatty lesions and erosions of the SIJ .
METHODS	Differences between techniques and methods were evaluated by intraclass correlation coefficients ( ICC ) and standardized response means ( SRM ) .
RESULTS	Applying the simple Berlin method , mean fatty lesion scores for etanercept-treated patients were 4.59 and 5.19 at baseline and Week 48 , respectively , while the comprehensive Berlin method revealed mean fatty lesion scores of 6.59 and 7.64 , respectively .
RESULTS	Corresponding SRM were 0.59 and 0.86 for simple and comprehensive methods , respectively , while ICC dropped from 0.76-0 .77 to 0.59-0 .62 .
RESULTS	Scoring of erosions on T1w opGRE images resulted in a higher interreader agreement ( ICC of 0.65 ) compared to T1w TSE sequences ( ICC of 0.18 ) .
CONCLUSIONS	Better characterization of fatty lesion changes within 1 year was achieved by the comprehensive Berlin scoring method ; however , more reader variation has to be taken into account .
CONCLUSIONS	The delineation of erosions is markedly improved when using T1w opGRE pulse sequences .

###24255767
BACKGROUND	Previous studies have shown that MRI of fresh hamstring injuries have diagnostic and prognostic value .
BACKGROUND	The clinical relevance of MRI at return to play ( RTP ) has not been clarified yet .
BACKGROUND	The aim of this study is to describe MRI findings of clinically recovered hamstring injuries in amateur , elite and professional athletes that were cleared for RTP .
METHODS	We obtained MRI of 53 consecutive athletes with hamstring injuries within 5days of injury and within 3days of RTP .
METHODS	We assessed the following parameters : injured muscle , grading of injury , presence and extent of intramuscular signal abnormality .
METHODS	We recorded reinjuries within 2months of RTP .
RESULTS	MRIs of the initial injury showed 27 ( 51 % ) grade 1 and 26 ( 49 % ) grade 2 injuries .
RESULTS	Median time to RTP was 28days ( range 12-76 ) .
RESULTS	On MRI at RTP 47 athletes ( 89 % ) had intramuscular increased signal intensity on fluid-sensitive sequences with a mean longitudinal length of 77mm ( 53 ) and a median cross-sectional area of 8 % ( range 0-90 % ) of the total muscle area .
RESULTS	In 22 athletes ( 42 % ) there was abnormal intramuscular low-signal intensity .
RESULTS	We recorded five reinjuries .
CONCLUSIONS	89 % of the clinically recovered hamstring injuries showed intramuscular increased signal intensity on fluid-sensitive sequences on MRI .
CONCLUSIONS	Normalisation of this increased signal intensity seems not required for a successful RTP .
CONCLUSIONS	Low-signal intensity suggestive of newly developed fibrous tissues is observed in one-third of the clinically recovered hamstring injuries on MRI at RTP , but its clinical relevance and possible association with increased reinjury risk has to be determined .

###24742226
OBJECTIVE	This study investigated the soothing effects of fragrance from yuzu , a Japanese citrus fruit ( Citrus junos Sieb .
OBJECTIVE	ex Tanaka ) , with salivary chromogranin A ( CgA ) used as an endocrinologic stress marker reflecting sympathetic nervous system activity .
METHODS	Twenty healthy women ( mean age , 20.5 0.1 years ) participated in a randomized , controlled , crossover study .
METHODS	Participants were examined on two separate occasions-once using the yuzu scent and once using unscented water as a control-in the follicular phase .
METHODS	This experiment measured salivary CgA and the Profile of Mood States ( POMS ) as a psychological index before and after the aromatic stimulation .
RESULTS	Ten-minute inhalation of the yuzu scent significantly decreased salivary CgA .
RESULTS	At 30 minutes after the inhalation period , the salivary CgA level further decreased .
RESULTS	In addition , POMS revealed that inhalation of the aromatic yuzu oil significantly decreased total mood disturbance , a global measure of affective state , as well as four subscores of emotional symptoms ( tension-anxiety , depression-dejection , anger-hostility , and confusion ) , as long as 30 minutes after the olfactory stimulation .
CONCLUSIONS	Yuzu 's aromatic effects may alleviate negative emotional stress , which , at least in part , would contribute to the suppression of sympathetic nervous system activity .

###24341367
BACKGROUND	Photodynamic therapy ( PDT ) with methyl aminolevulinate ( MAL ) is effective for treating multiple actinic keratoses ( AKs ) .
BACKGROUND	Ablative fractional laser ( FL ) creates vertical channels that may facilitate MAL delivery and improve PDT response .
OBJECTIVE	To evaluate the efficacy of FL-assisted PDT ( FL-PDT ) in treating facial AKs in Korean patients .
METHODS	A prospective randomized non-blinded trial initially evaluated 271 facial AKs in 45 patients .
METHODS	All patients underwent one session of MAL-PDT using a red light-emitting diode lamp at 37J/cm ( 2 ) , and 23 patients with 135 AK lesions were randomly assigned to pre-treatment with a 2940-nm ablative fractional erbium : Yag laser .
METHODS	Patients were followed up at 1 , 2 and 4weeks and every month until 6 and 12months post-treatment .
METHODS	Response , adverse events , cosmetic outcome and patient satisfaction were documented .
METHODS	Finally , a total of 236 facial AKs in 40 patients were enrolled and analysed in this study .
RESULTS	FL-PDT was significantly more effective than MAL-PDT at treating all AK grades ( 86.9 % vs. 61.2 % ; P < 0.001 ) .
RESULTS	The efficacy of FL-PDT was most pronounced in treating Olsen grade III AKs ( 69.4 % vs. 32.5 % ; P = 0.001 ) .
RESULTS	FL-PDT also showed a lower lesion recurrence rate than MAL-PDT ( 9.7 % vs. 26.6 % ; P = 0.004 ) .
RESULTS	Excellent or good cosmetic outcome was reported in > 90 % cases .
RESULTS	Erythema and hyperpigmentation intensities were higher in the FL-PDT group ( P > 0.05 ) .
RESULTS	Side-effects were more frequent in the FL-PDT group , but these were mild and well tolerated ( P > 0.05 ) .
CONCLUSIONS	FL-PDT is effective for treating AKs , especially moderate-to-thick lesions .

###25109820
BACKGROUND	Oral glucocorticoids are widely used to reduce pruritus and dermatitis associated with allergic dermatitis .
BACKGROUND	Data suggest that oclacitinib , a Janus kinase inhibitor , is a safe and effective alternative .
OBJECTIVE	To evaluate the efficacy and safety of oclacitinib compared with prednisolone for the control of pruritus associated with allergic dermatitis in a single-masked , controlled clinical trial with a randomized complete block design .
METHODS	Client-owned dogs ( n = 123 ) with a presumptive diagnosis of allergic dermatitis and moderate to severe pruritus as assessed by the pet owner were enrolled .
METHODS	Dogs were randomized to treatment with either oclacitinib ( 0.4-0 .6 mg/kg orally twice daily for 14days , then once daily ) or prednisolone ( 0.5-1 .0 mg/kg once daily for 6days , then every other day ) for 28days .
METHODS	An enhanced visual analog scale ( VAS ) was used by owners to assess pruritus and by veterinarians to assess dermatitis , at all time points assessed .
RESULTS	Both treatments produced a rapid onset of efficacy within 4h .
RESULTS	The mean reductions in pruritus and dermatitis scores were not significantly different between the treatments except on day14 , when reductions were more pronounced for oclacitinib than prednisolone ( P = 0.0193 for owner pruritus scores ; P = 0.0252 for veterinarian dermatitis scores ) .
RESULTS	Adverse events were reported with similar frequency in both groups .
CONCLUSIONS	In this study , both oclacitinib and prednisolone provided rapid , effective and safe control of pruritus associated with allergic dermatitis , with substantial improvement in pruritus , reported by owners , and dermatitis , reported by veterinarians .

###24332687
OBJECTIVE	To evaluate the effectiveness of topical anaesthesia with cocaine versus lidocaine plus adrenaline for outpatient transcanalicular and endonasal dacryocystorhinostomy ( TCLDCR ) with diode laser under sedation .
METHODS	A double blind randomised clinical trial was designed using topical anaesthesia for outpatient TCLDCR in the treatment of adult epiphora .
METHODS	A total of 92 patients were enrolled , and randomly allocated to be operated on under sedation and topical anaesthesia with cocaine 4 % pledgets versus sedation and topical anaesthesia with lidocaine 2 % plus 1/100 .000 adrenaline pledgets .
METHODS	Main outcome measures were postoperative comfort , evaluated by a visual analogue scale , presence of secondary effects ( blood pressure , heart rate ) , and resolution of epiphora , evaluated by Munk 's scale and endoscopic control .
RESULTS	Patients in both groups reported being comfortable during and immediately after TCLDCR .
RESULTS	Visualization of the operative field was adequate , and surgery was successfully completed in all cases .
RESULTS	Complications were more common in the cocaine group : Sixteen patients from the cocaine group had high blood pressures , versus 2 patients from the lidocaine group ( RR = 8 ) .
RESULTS	Mean blood loss was 6.09 ml in cocaine group , versus 2.05 ml in lidocaine group ( RR = 6 ) .
RESULTS	Both parameters were statistically significant ( p = 1,110 ( -9 ) ) .
RESULTS	There were no cases of postoperative epistaxis requiring nasal packing or hospital admission in any group .
RESULTS	Success rate was similar in the 2 groups ( 86.96 % group 1 and 89.13 % group 2 ) , after 6 months of follow-up .
CONCLUSIONS	The combination of topical lidocaine and adrenaline is more effective for outpatient transcanalicular and endonasal dacryocystorhinostomy than topical cocaine .
CONCLUSIONS	Patient comfort was adequate in both groups , but high blood pressure and blood loss more common after cocaine .

###25599735
BACKGROUND	This study was aimed to assess the ratio of total cholesterol ( TC ) to high-density density lipoprotein cholesterol ( HDLC ) and plasma nitrate levels in patients with ischemic nephropathy receiving statins and niacin extended release ( NER ) .
METHODS	Kidney disease patients with a history of at least 5 year of diabetes mellitus or 10 year of hypertension were screened by renal artery Doppler ultrasonography .
METHODS	Participants were randomly assigned into two groups to receive atorvastatin , 20 mg/d , with and without NER , 500 mg/d , for 16 weeks .
METHODS	Serum levels of lipid profile , creatinine , and nitrate were compared before and after the study .
RESULTS	Fifty-four patients received the statin and 51 received statin-NER combination .
RESULTS	Both statin and statin-NER groups demonstrated significant decreases in plasma levels of TC and low-density lipoprotein cholesterol .
RESULTS	Triglyceride and very low-density lipoprotein cholesterol were significantly lowered only with statin-NER combination .
RESULTS	The increase in HDLC level was found in both groups , but significant only with statin-NER combination therapy ( P < .001 ) .
RESULTS	Atorvastatin combined with NER reduced TC/HDLC ratio almost double as compared with that of atorvastatin alone ( 102 % and 36.6 % reduction , respectively ) .
RESULTS	A similar pattern was observed for nitrate levels ( 33 % and 65 % , respectively ) .
CONCLUSIONS	These findings indicated that a reduction in TC/HDLC ratio improves endothelial function in renovascular disease and use of NER in combination with atorvastatin may provide better outcomes .
CONCLUSIONS	This could be helpful in attenuating further vascular damage and associated systemic complications .

###24229674
BACKGROUND	Elevated fibrinogen ( Fg ) level is a known risk factor for ischemic stroke .
BACKGROUND	There are few clinical trials on oral fibrinogen-depleting therapies for secondary ischemic stroke prevention .
BACKGROUND	We aimed to assess the effects of one-year therapy with oral lumbrokinase enteric-coated capsules on secondary ischemic stroke prevention .
METHODS	This is a multicenter , randomized , parallel group and controlled study that began treatment in hospitalized patients with ischemic stroke and continued for 12 months .
METHODS	Patients were randomized to either the control group that received the standard stroke treatment or the fibrinogen-depleting group that received the standard stroke treatment plus enteric-coated lumbrokinase capsules .
METHODS	The NIH Stroke Scale scores ( NIHSSs ) and plasma Fg level were recorded .
METHODS	The carotid artery intima-media thickness ( IMT ) and status of plaques were examined through carotid ultrasound examination .
METHODS	Primary outcomes included all-cause mortality , any event of recurrent ischemic stroke/transient ischemic attack ( TIA ) , hemorrhagic stroke , myocardial infarction and angina , and other noncerebral ischemia or hemorrhage .
METHODS	Kaplan-Meier survival analysis and the Long-rank test were used to compare total vascular end point incidence between the two groups .
METHODS	Comparison of median values between two groups was done by the Student t test , one-way analysis of variance ( ANOVA ) , or non-parametric rank sum test .
RESULTS	A total of 310 patients were enrolled , 192 patients in the treatment group and 118 patients in the control group .
RESULTS	Compared to the control group , the treatment group showed favorable outcomes in the Fg level , carotid IMT , the detection rate of vulnerable plaques , the volume of carotid plaques , NIHSS scores , and incidence of total vascular ( 6.78 % and 2.08 % , respectively ) and cerebral vascular events ( 5.93 % and 1.04 % , respectively ) ( P < 0.05 ) .
RESULTS	In the treatment group , the volume of carotid plaques was significantly related to the carotid IMT , the plaque diameter , width and number ( P = 0.000 , 0.000 , 0.000 , 0.022 ; F = 13.51 , 2.52 , 11.33 , -3.29 , but there was a weak correlation with the Fg level ( P = 0.056 ) .
RESULTS	After 1-year therapy , the incidence of overall vascular end points was reduced by 4.7 % .
CONCLUSIONS	Long-term oral fibrinogen-depleting therapy may be beneficial for secondary ischemic stroke prevention .

###24431394
OBJECTIVE	This 52-week , randomised , double-blind phase IIIb study assessed efficacy and safety of certolizumab pegol ( CZP ) as add-on therapy to non-biologic disease-modifying antirheumatic drugs ( DMARDs ) in rheumatoid arthritis ( RA ) patients with low to moderate disease activity , and stopping therapy in patients in sustained remission .
METHODS	Patients were randomised 1:1 to CZP ( 400mg at weeks 0 , 2 and 4 , then 200mg every 2weeks ) or placebo ( every 2weeks ) plus current non-biologic DMARDs .
METHODS	At week 24 , patients who achieved the primary endpoint of Clinical Disease Activity Index ( CDAI ) remission at both weeks 20 and 24 stopped study treatment and continued in the study until week 52 .
RESULTS	Of 194 patients ( CZP = 96 ; placebo = 98 ) , > 90 % had moderate disease activity at baseline .
RESULTS	Significantly more CZP patients met the primary endpoint than placebo patients ( week 20 and 24 CDAI remission rates : 18.8 % vs 6.1 % ; p0 .05 ) .
RESULTS	At week 24 , 63.0 % vs 29.7 % of CZP versus placebo patients ( p < 0.001 ) achieved LDA .
RESULTS	Disease activity score ( ESR ) based on 28-joint count and Simplified Disease Activity Index remission rates were also significantly higher with CZP versus placebo ( 19.8 % vs 3.1 % ; p0 .01 and 14.6 % vs 4.1 % ; p0 .05 ) .
RESULTS	CZP patients reported improvements in physical function versus placebo ( mean Health Assessment Questionnaire-Disability-Index change from baseline : CZP , -0.25 vs placebo , -0.03 ; p0 .01 ) .
RESULTS	During the period following withdrawal of CZP or placebo , only 3/17 prior CZP patients and 2/6 prior placebo patients maintained CDAI remission until week 52 , but CZP reinstitution allowed renewed improvement .
RESULTS	Adverse and serious adverse event rates were comparable between CZP and placebo groups .
CONCLUSIONS	Addition of CZP to non-biologic DMARDs is an effective treatment in RA patients with predominantly moderate disease activity , allowing low-disease activity or remission to be reached in a majority of the patients .
CONCLUSIONS	However , the data suggest that CZP can not be withdrawn in patients achieving remission .
BACKGROUND	NCT00674362 .

###24928639
OBJECTIVE	The purpose of this analysis is to report the incremental costs and benefits of different doses of spinal manipulative therapy ( SMT ) in patients with chronic low back pain ( LBP ) .
METHODS	We randomized 400 patients with chronic LBP to receive a dose of 0 , 6 , 12 , or 18 sessions of SMT .
METHODS	Participants were scheduled for 18 visits for 6 weeks and received SMT or light massage control from a doctor of chiropractic .
METHODS	Societal costs in the year after study enrollment were estimated using patient reports of health care use and lost productivity .
METHODS	The main health outcomes were the number of pain-free days and disability-free days .
METHODS	Multiple regression was performed on outcomes and log-transformed cost data .
RESULTS	Lost productivity accounts for most societal costs of chronic LBP .
RESULTS	Cost of treatment and lost productivity ranged from $ 3398 for 12 SMT sessions to $ 3815 for 0 SMT sessions with no statistically significant differences between groups .
RESULTS	Baseline patient characteristics related to increase in costs were greater age ( P = .03 ) , greater disability ( P = .01 ) , lower quality-adjusted life year scores ( P = .01 ) , and higher costs in the period preceding enrollment ( P < .01 ) .
RESULTS	Pain-free and disability-free days were greater for all SMT doses compared with control , but only SMT 12 yielded a statistically significant benefit of 22.9 pain-free days ( P = .03 ) and 19.8 disability-free days ( P = .04 ) .
RESULTS	No statistically significant group differences in quality-adjusted life years were noted .
CONCLUSIONS	A dose of 12 SMT sessions yielded a modest benefit in pain-free and disability-free days .
CONCLUSIONS	Care of chronic LBP with SMT did not increase the costs of treatment plus lost productivity .

###24724767
OBJECTIVE	To examine whether a phenylalanine-free protein substitute with prolonged release may be beneficial to the protein status of children with phenylketonuria ( PKU ) compared to conventional substitutes .
METHODS	Sixty children with PKU , 7 to 16 years of age , were randomly allocated to receive either a prolonged-release ( test ) or the current conventional protein substitute for 30 days .
METHODS	Subjects were additionally sex and age matched with 60 subjects with mild hyperphenylalaninemia and 60 unaffected subjects .
METHODS	The protein status in children with PKU was assessed by albumin , transthyretin , and retinol-binding protein ( RBP ) , and changes throughout the trial period were the primary outcome measures .
RESULTS	Children with PKU did not differ in anthropometry from children with mild hyperphenylalaninemia or unaffected children but they ingested lower amounts of proteins ( p < 0.01 ) .
RESULTS	No differences occurred throughout the trial between or within children with PKU who received the test or conventional substitute for macronutrient intake .
RESULTS	Albumin and RBP concentrations were within the age-specific reference range for all children .
RESULTS	The rate of protein insufficiency ( transthyretin concentration less than 20 mg/dL ) did not differ statistically between children receiving test or conventional substitute ( recruitment 51.8 % vs 53.6 % ; end of the trial 44.4 % vs 50.0 % ) but mean transthyretin recovered over 20 mg/dL in children who received the test substitute , increasing from 19.1 to 20.7 mg/dL ( mean change , 1.6 mg/dL ; 95 % confidence interval 0.4 to 2.8 mg/dL ) .
RESULTS	In children receiving conventional substitute mean transthyretin changed from 19.0 to 19.2 mg/dL ( 0.2 ; -0.2 to 0.6 ) mg/dL .
CONCLUSIONS	Protein substitutes with prolonged release might be beneficial to protein status in children with phenylketonuria .

###24945621
OBJECTIVE	Spinal cord stimulation ( SCS ) for the treatment of chronic pain is a well-established therapy .
OBJECTIVE	However , the requirement that paresthesia be continually felt by the patient has important downsides .
OBJECTIVE	This study evaluated the effectiveness of a new paresthesia-free SCS paradigm , called burst stimulation , for the treatment of failed back surgery syndrome ( FBSS ) with a prospective , randomized , double-blind , placebo-controlled design .
METHODS	Twenty patients with FBSS and a preexisting SCS system each received three treatment allocations in random order for a period of one week : 500-Hz tonic stimulation , burst stimulation , and placebo stimulation .
METHODS	The primary outcome measure was pain intensity measured on a numerical rating scale ( NRS ) .
METHODS	Secondary outcome measures were pain quality measured using the Short-Form McGill Pain Questionnaire ( SFMPQ ) and safety .
METHODS	Additional data were collected relating to pain-related disability measured using the Oswestry Disability Index ( ODI ) .
RESULTS	The lowest mean NRS and SFMPQ scores were observed under burst stimulation .
RESULTS	For the burst stimulation treatment group , mean NRS and SFMPQ scores were significantly decreased compared with the other treatment groups .
RESULTS	Mean NRS and SFMPQ scores were not significantly different between 500-Hz tonic stimulation and placebo stimulation .
RESULTS	Although the lowest mean ODI score was observed under burst stimulation , no significant differences were found between the ODI categories .
RESULTS	No adverse events occurred , and burst stimulation was significantly preferred by 16 patients ( 80 % ) .
CONCLUSIONS	Overall , burst stimulation resulted in significantly better pain relief and improved pain quality in the short term compared with 500-Hz tonic stimulation and placebo stimulation and was preferred by the majority of patients .

###25042311
BACKGROUND	During recent years scientific research has demonstrated a growing interest in elastic and anaelastics adhesive taping techniques .
BACKGROUND	However , only a few studies investigating the principles behind the effects of taping .
BACKGROUND	At present , the action mechanisms of kinesiology taping remain speculative .
OBJECTIVE	To investigate the effects of taping application on the tone of the pectoralis major muscle at rest , in absence of any relevant pathologies .
METHODS	The study involved a prospective , randomised and blinded clinical trial on healthy individuals and a repeated measures study design .
METHODS	Two different taping techniques ( facilitatory and inhibitory ) were applied over the pectoralis major of 24 healthy volunteers .
METHODS	The outcome measure was passive range of motion of external rotation of the glenohumeral joint .
RESULTS	Facilitatory taping significatively enhanced the activity of the underlying muscle .
RESULTS	Results showed a negative correlation between facilitatory taping application and the contralateral pectoralis major length , indicating a possible effect on the muscle tone of areas outside the site of direct application .
RESULTS	The inhibitory taping application did not produce significant results .
CONCLUSIONS	effects on ipsilateral and contralateral muscle physiology could be interpreted through the initial hypothesis of taping inducing changes in fascial stiffness .
CONCLUSIONS	These could be transmitted along the continuing system .
CONCLUSIONS	Further studies are needed to inform the possible uses of taping in clinical practice .

###24734891
BACKGROUND	The objective of the current study was to assess mean self-monitored blood glucose ( SMBG ) , on day 6 of 6 days of continuous reservoir wear ( 6D ) , with insulin lispro ( Lis ) or insulin aspart ( Asp ) .
METHODS	Two 24-week , randomized trials were conducted in subjects with type 1 diabetes treated by continuous subcutaneous insulin infusion ( CSII ) for 6 months , with a mean total daily insulin dose capable of supporting 6 days of in-reservoir use .
METHODS	Study 1 had an open-label , six-sequence , three-treatment , three-period , cross-over design .
METHODS	Study 2 had a double-blind , two-sequence , two-treatment , two-period , cross-over design .
METHODS	The primary efficacy measure was the mean of Day 6 , seven-point SMBG profiles for insulin lispro 6D ( Lis6D ) and insulin aspart 6D ( Asp6D ) treatment periods .
METHODS	Safety measures were also assessed .
RESULTS	Lis did not achieve noninferiority ( SMBG ; margin = 0.6 mmol/L [ 10.8 mg/dL ] ) to Asp on Day 6 of reservoir wear in either Study ( least-squares mean difference : Study 1 = 0.48 mmol/L [ 8.64 mg/dL ] ; 95 % confidence interval [ CI ] [ 0.20 , 0.76 ] , Study 2 = 0.36 mmol/L [ 6.49 mg/dL ] ; 95 % CI [ 0.06 , 0.66 ] ) .
RESULTS	Noninferiority was demonstrated for overall daily mean of SMBG values over days 1 to 6 of reservoir use during each treatment period .
RESULTS	In the Lis treatment period , subjects reported a lower documented and total hypoglycemia rate per 30 days and a higher rate of non-explained hyperglycemia than in the Asp treatment period .
CONCLUSIONS	While the mean blood glucose on Day 6 of Lis6D did not meet non-inferiority , the overall daily mean blood glucose was not different , with a decreased rate of hypoglycemia with Lis .

###25306520
OBJECTIVE	Two types of material are used to manufacture double-lumen endobronchial tubes ( DLTs ) : Polyvinylchloride ( PVC ) and silicon .
OBJECTIVE	PVC DLTs ( Broncho-Cath ) and silicon DLTs ( Silbroncho ) not only differ in material , but also subtly differ in structure .
OBJECTIVE	The goal of this study was to determine whether the incidences of postoperative sore throat and hoarseness differed between PVC DLTs and silicon DLTs .
METHODS	Prospective , single-blind , balanced ( 1:1 ) , randomized , controlled trial .
METHODS	Single university hospital .
METHODS	Sixty ASA I-II patients , aged 20 to 65 years , scheduled for thoracoscopic pulmonary lobectomy .
METHODS	Patients were randomized into the Broncho-cath group ( group B , n = 30 ) and the Silbroncho group ( group S , n = 30 ) .
METHODS	Intubation was performed with DLT according to the allocated group by an anesthesiologist .
RESULTS	The incidence of sore throat and hoarseness was evaluated at 1 hour and 24 hours after DLT extubation .
RESULTS	The intensity of sore throat was assessed by visual analog scale ( VAS < 0-10 ) at 1 , 2 , 4 , 12 , and 24 hours after DLT extubation .
RESULTS	The incidence of sore throat was significantly lower in group S compared with that in group B at 1 h ( 30 % v 66.7 % , p = 0.018 ) and 24 hours ( 10 % v 43.3 % , p = 0.014 ) .
RESULTS	No significant difference was observed in the incidence of hoarseness between the 2 groups .
RESULTS	The VAS scores for sore throat in group B were significantly higher than those in group S throughout the study ( p < 0.05 ) .
CONCLUSIONS	The use of silicon DLTs resulted in a lower incidence of postoperative sore throat than did the use of PVC DLTs .

###25532068
OBJECTIVE	Pyridoxamine dihydrochloride ( Pyridorin ) blocks pathogenic oxidative pathways in the progression of diabetic nephropathy .
OBJECTIVE	The pyridoxamine pilot study was designed to test entry criteria and outcomes .
OBJECTIVE	Subjects had SCr 1.3-3 .5 mg/dl , protein-to-creatinine 1,200 mg/g and used a surrogate outcome of SCr over 52 weeks .
OBJECTIVE	Subjects had to be on a maximally tolerated dose of ACE/ARB for 3 months ; stable other antihypertensive doses for 2 months ; stable diuretic dose for 2 weeks , and BP 160/90 mm Hg ; or enter a Pharmaco-Stabilization Phase ( PSP ) .
OBJECTIVE	This pilot failed to detect an effect on SCr in intent-to-treat analysis .
METHODS	We queried the locked clinical trial database for subgroups in which there was a treatment effect .
RESULTS	Subjects not requiring PSP and those with entry SCr < 2.0 mg/dl had a treatment effect .
RESULTS	Subjects entering PSP required more changes in antihypertensive medications and experienced larger SCr over 52 weeks .
RESULTS	PSP subjects with BP > 140/90 mm Hg had no treatment effect , but those 140/90 mm Hg did .
CONCLUSIONS	Time required for acute effects of ACE/ARB to stabilize is unknown , but these data suggest > 3 months .
CONCLUSIONS	Thus , subjects in the pivotal trial must be on ACE/ARB for 6 months .
CONCLUSIONS	Frequent antihypertensive adjustment could engender SCr changes unrelated to CKD progression .
CONCLUSIONS	Thus , we will require subjects to have BP 150/90 mm Hg and on stable antihypertensives for 26 weeks , or 140/90 mm Hg and on stable antihypertensives for 13 weeks .
CONCLUSIONS	Since SCr over 52 weeks is limited as a surrogate outcome , the pivotal trial uses a time-to-event analysis of baseline SCr to at least a 50 % increase in SCr or ESRD as the primary outcome .
CONCLUSIONS	This substantial SCr is protected from noise and is clinically relevant .
CONCLUSIONS	The pyridoxamine pilot provided critical information to inform the design of PIONEER-CSG-17 , which we conducted under the SPA agreement with FDA .

###25018624
BACKGROUND	The efficacy of coronary angiography may be different in the right radial approach ( RRA ) and the left radial approach ( LRA ) due to more common vascular tortuosity in the RRA .
BACKGROUND	The aim of the study was to determine whether LRA is a valid alternative for coronary angiography compared with RRA in Asian populations .
METHODS	This is a single-center , prospective , randomized controlled study .
METHODS	A total of 1,400 consecutive patients undergoing diagnostic coronary angiography were recruited and randomized to the RRA ( number [ n ] = 700 ) or LRA ( n = 700 ) group .
METHODS	The primary end point was total procedural duration .
METHODS	Secondary end points included fluoroscopy time , dose of radiation including cumulative air kerma and dose area product , contrast volume , and the incidence of vascular complications .
RESULTS	Coronary procedural success was achieved in 682 of 700 ( 97.4 % ) patients in the RRA and 680 of 700 ( 97.1 % ) in the LRA .
RESULTS	The total procedural time ( RRA 14.16.3 minutes versus LRA 13.26.0 minutes ; P = 0.006 ) and fluoroscopy time ( RRA 3.83.3 minutes versus LRA 3.42.8 minutes ; P = 0.046 ) were significantly shorter via LRA in comparison to RRA .
RESULTS	The percentage of hydrophilic wire use was also lower in the LRA group ( 14 % [ RRA ] versus 10 % [ LRA ] ; P = 0.016 ) .
RESULTS	The dose of radiation and contrast volume were not different between the two approaches .
RESULTS	No cases of major bleeding and vascular complications requiring surgical intervention were reported , other than with one patient who experienced a symptomatic stroke and died in the RRA group compared with none in the LRA group .
CONCLUSIONS	The LRA seems to be a feasible alternative for coronary angiography in Asian patients due to shorter procedural duration and fluoroscopy time , as well as less hydrophilic wire use in comparison to RRA .

###24461029
BACKGROUND	The potential health benefits of curcumin are limited by its poor solubility , low absorption from the gut , rapid metabolism and rapid systemic elimination .
BACKGROUND	The purpose of this study was the comparative measurement of the increases in levels of curcuminoids ( curcumin , demethoxycurcumin , bisdemethoxycurcumin ) and the metabolite tetrahydrocurcumin after oral administration of three different curcumin formulations in comparison to unformulated standard .
METHODS	The relative absorption of a curcumin phytosome formulation ( CP ) , a formulation with volatile oils of turmeric rhizome ( CTR ) and a formulation of curcumin with a combination of hydrophilic carrier , cellulosic derivatives and natural antioxidants ( CHC ) in comparison to a standardized curcumin mixture ( CS ) was investigated in a randomized , double-blind , crossover human study in healthy volunteers .
METHODS	Samples were analyzed by HPLC-MS/MS .
RESULTS	Total curcuminoids appearance in the blood was 1.3-fold higher for CTR and 7.9-fold higher for CP in comparison to unformulated CS .
RESULTS	CHC showed a 45.9-fold higher absorption over CS and significantly improved absorption over CP ( 5.8-fold ) and CTR ( 34.9-fold , all p < 0.001 ) .
CONCLUSIONS	A formulation of curcumin with a combination of hydrophilic carrier , cellulosic derivatives and natural antioxidants significantly increases curcuminoid appearance in the blood in comparison to unformulated standard curcumin CS , CTR and CP .

###25013787
BACKGROUND	After pancreaticoduodenectomy , the Finnish binding pancreaticojejunal anastomosis ( FBPJ ) seems to reduce the risk for pancreatic fistula ( POPF ) .
BACKGROUND	Our aim was to investigate whether FBPJ is feasible and prevents the risk for POPF even after left pancreatectomy ( LP ) .
METHODS	47 consecutive patients underwent LP .
METHODS	27 patients were recruited on the basis of CT and , of these , 16 patients were randomized on the basis of findings during surgery ( transection line must be left of portal vein , as 2-3cm pancreatic mobilization is required for FBPJ ) to receive either Roux-Y FBPJ or hand-sewn closure of the pancreatic remnant .
RESULTS	Only 34 % ( 16/47 ) of the patients met the randomization criteria .
RESULTS	Clinically significant POPF rate was higher in FBPJ group ( 60 % ) compared to thand-sewn closure group ( 13 % ; P < 0.05 ) .
RESULTS	POPF rate in FBPJ group was higher even when compared to all patients with hand-sewn closure ( 60 % versus 37 % ; P < 0.05 ) .
RESULTS	Overall , FBPJ was technically feasible for only 28 % of patients .
CONCLUSIONS	FBPJ can not be recommended for the routine closure of the pancreatic remnant after LP , as it was not technically achievable in 72 % of the cases .
CONCLUSIONS	Moreover , the technique does not seem to reduce the risk for POPF compared to the hand-sewn closure .

###24724887
BACKGROUND	Disulfiram and naltrexone were evaluated in treatment of individuals with co-occurring alcohol dependence and other Axis I disorders ( e.g. , Major Depression ) .
BACKGROUND	We explored pharmacogenetic interactions in genotyped subjects .
METHODS	Alcohol dependent ( AD ) subjects received naltrexone alone , placebo alone , disulfiram with placebo or disulfiram with naltrexone .
METHODS	They were genotyped for OPRM1 rs1799971 ( Asn40Asp ) , and DBH rs1611115 ( C-1021T ) .
METHODS	N = 107 male European-American subjects were included .
RESULTS	There were no significant interactions with OPRM1 .
RESULTS	DBH interacted with naltrexone on the primary outcome of abstinence from heavy drinking ( ( 2 ) ( 1 ) = 5.23 , p = .02 ) .
RESULTS	`` T '' allele carriers on naltrexone had more abstinence compared to `` CC '' subjects on naltrexone ( FET , p = .01 ) .
RESULTS	`` T '' allele carriers on naltrexone had the highest overall rates of abstinence from heavy drinking ( > 90 % ) .
RESULTS	Also , DBH genotype interacted with disulfram ( F ( 1,17 ) = 7.52 , p = .01 ) on drinks per drinking day with less drinking for subjects with the `` CC '' genotype than for T allele carriers on disulfiram .
CONCLUSIONS	DBH * rs1611115 * T associated with better response to naltrexone , while for those on disulfiram that drank , `` CC '' subjects drank less than T carriers .
CONCLUSIONS	For rs1799971 * G , we did not replicate findings from previous studies showing a more favorable response to NTX , possibly due to the small available sample .
CONCLUSIONS	Genotyping rs1611115 may be useful in understanding inter-individual differences in AD treatment response .
CONCLUSIONS	Further study of rs1611115 pharmacogenetics is warranted .

###25500940
BACKGROUND	Hip fracture is a condition with high mortality and morbidity in elderly frail patients .
BACKGROUND	Intraoperative fluid optimization may be associated with benefit in this population .
BACKGROUND	We investigated whether intraoperative fluid management using pulse-contour analysis cardiac monitoring , compared with standard care in patients undergoing spinal anaesthesia , would provide benefits in terms of reduced time until medically fit for discharge and postoperative complications .
METHODS	Patients undergoing surgical repair of fractured neck of femur , aged > 60 yr , receiving spinal anaesthesia were enrolled in this single-centre , blinded , randomized , parallel group trial .
METHODS	Patients were allocated to either anaesthetist-directed fluid therapy or a pulse-contour-guided fluid optimization strategy using colloid ( Gelofusine ) boluses to optimize stroke volume .
METHODS	The primary outcome was time until medically fit for discharge .
METHODS	Secondary outcomes included postoperative complications , mobility , and mortality .
METHODS	We updated a systematic review to include relevant trials to 2014 .
RESULTS	We recruited 130 patients .
RESULTS	Time until medically fit for discharge was similar in both groups , mean [ 95 % confidence interval ( CI ) ] 12.2 ( 11.1-13 .5 ) vs 13.1 ( 11.9-14 .5 ) days ( P = 0.31 ) , as was total length of stay 14.2 ( 12.9-15 .8 ) vs 15.3 ( 13.8-17 .2 ) days ( P = 0.32 ) .
RESULTS	There were no significant differences in complications , function , or mortality .
RESULTS	An updated meta-analysis ( four studies , 355 patients ) found non-significant reduction in early mortality [ relative risk 0.66 ( 0.24-1 .79 ) ] and in-hospital complications [ relative risk 0.80 ( 0.61-1 .05 ) ] .
CONCLUSIONS	Goal-directed fluid therapy during hip fracture repair under spinal anaesthesia does not result in a significant reduction in length of stay or postoperative complications .
CONCLUSIONS	There is insufficient evidence to either support or discount its routine use .
BACKGROUND	ISRCTN88284896 .

###25143722
BACKGROUND	We recently published that platelet-activating factor receptor ( PAFr ) is upregulated on the epithelium of the proximal airways of current smokers and also in bronchial epithelial cells exposed to cigarette smoke extract .
BACKGROUND	These treated cells also showed upregulation of Streptococcus pneumoniae adhesion .
BACKGROUND	Bacterial wall phosphorylcholine specifically binds to PAFr expressed on airway epithelium , thus facilitating adherence and tissue invasion , which may be relevant to chronic obstructive pulmonary disease ( COPD ) .
BACKGROUND	Moreover , the use of inhaled corticosteroids ( ICS ) in COPD patients is associated with an increased risk of invasive respiratory pneumococcal infections .
OBJECTIVE	In this study , we have investigated whether PAFr expression is especially upregulated in airway epithelium in COPD patients and whether this expression may be modulated by ICS therapy .
METHODS	We cross-sectionally evaluated PAFr expression in bronchial biopsies from 15 COPD patients who were current smokers ( COPD-smokers ) and 12 COPD-ex-smokers , and we compared these to biopsies from 16 smokers with normal lung function .
METHODS	We assessed immunostaining with anti-PAFr monoclonal antibody .
METHODS	We also used material from a previous double-blinded randomized placebo-controlled 6-month ICS intervention study in COPD patients to explore the effect of ICS on PAFr expression .
METHODS	We employed computer-aided image analysis to quantify the percentage of epithelium stained for PAFr .
RESULTS	Markedly enhanced expression of PAFr was found in both COPD-smokers ( P < 0.005 ) and COPD-ex-smokers ( P < 0.002 ) compared to smokers with normal lung function .
RESULTS	There was little evidence that PAFr expression was affected by ICS therapy over 6 months .
CONCLUSIONS	Epithelial PAFr expression is upregulated in smokers , especially in those with COPD , and is not obviously affected by ICS therapy .

###24291047
BACKGROUND	Intramedullary nailing of displaced proximal humerus fractures is an attractive option in the elderly patient .
BACKGROUND	However , in recent reports , some existing intramedullary nails have shown high rate of complications , so new designs are being developed .
BACKGROUND	The objective of the present study is to report on outcomes and complications when comparing a straight to a curvilinear nail design .
METHODS	We prospectively include 54 patients with Neer 's 2 - or 3-part proximal humerus fractures .
METHODS	Two were lost to follow-up , 26 were surgically treated with a new straight humeral nail ( MultiLoc , Synthes ) mean age 69 ( range , 47-87 years ) , and 26 with a curvilinear nail ( Polarus , Acumed ) mean age 71 ( range , 38-89 years ) .
METHODS	At final follow-up ( average 14 months ) , patients underwent a clinical and radiographic evaluation .
METHODS	Clinical outcome was assessed with the adjusted Constant score .
RESULTS	All but 1 fracture went on to radiographic union .
RESULTS	Mean Constant score in the Polarus nail was 72.7 16.0 and 83.3 16.7 in the MultiLoc ( P = .246 ) .
RESULTS	Symptoms related with rotator cuff disease were present in 19/26 patients ( 73 % ) and in 9/26 ( 34.6 % ) , respectively ( P = .001 ) .
RESULTS	The mean neck-shaft angle at final follow-up was 135 in the MultiLoc group and 130 in the Polarus group ( P > .05 ) .
RESULTS	Reoperation rate was 42 % for Polarus and 11.5 % for MultiLoc .
CONCLUSIONS	Straight intramedullary nails had a comparable union rate to an accepted curvilinear design , with a much lower incidence of complications .
CONCLUSIONS	Rotator cuff pain and dysfunction can be minimized with the use of newer generation straight nails .

###24718066
METHODS	This was a prospective , randomized , controlled multicenter study with 24-month follow-up .
OBJECTIVE	The purpose of this study was to evaluate the safety and efficacy in a Food and Drug Administration Investigation Device Exemption of a new lumbar total disc replacement ( TDR ) by comparing it to an earlier TDR approved for sale .
BACKGROUND	Randomized trials have reported TDR to produce results similar or superior to lumbar fusion .
BACKGROUND	Results for various TDRs seem to be similar , but differences in study design and outcome measures pose challenges in definitively comparing devices .
BACKGROUND	The purpose of this study was to perform a direct comparison of 2 lumbar TDRs in a prospective , randomized trial .
METHODS	TDR was performed in 457 patients from 21 sites ( 261 patients in the investigational group ( Kineflex-L Disc ; metal-on-metal design anchored with keels , 204 randomized and 57 nonrandomized training cases ) , and 196 in the control group ( CHARITE artificial disc ; metal with polyethylene core with teeth for anchoring ; 190 randomized and 6 nonrandomized training cases ) .
METHODS	All patients were treated nonoperatively for single-level symptomatic disc degeneration for at least 6 months prior to surgery .
METHODS	Perioperative data were collected .
METHODS	Clinical outcome data were collected prospectively , as approved by the Food and Drug Administration , through 24-month follow-up .
METHODS	Primary outcome measures used were the Oswestry Disability Index , visual analogue scales assessing pain , patient satisfaction , and reoperations .
METHODS	Success was defined to be at least 15-point improvements in Oswestry Disability Index scores , no reoperation , and no major adverse events .
METHODS	Radiographical measures included range of motion , disc space height , and assessment for device migration , subsidence , and fusion at the TDR level .
RESULTS	There were no significant differences between the groups when comparing operative time , blood loss , or length of hospital stay .
RESULTS	Both groups improved significantly on Oswestry Disability Index and visual analogue scale scores ( P < 0.01 ) with no differences between the groups .
RESULTS	Success rates were similar ( 68.1 % investigational vs. 67.4 % control ) .
RESULTS	At 24-month follow-up , 94.1 % of the investigational group and 91.9 % of controls were satisfied with outcome .
RESULTS	Reoperation was performed in 10.3 % of the investigational group and 8.4 % of the control group .
CONCLUSIONS	This prospective , randomized , controlled study comparing 2 TDRs , the first to the authors ' knowledge , found the devices produced very similar clinical outcomes .
CONCLUSIONS	Both groups improved significantly by 6 weeks postoperatively and remained improved throughout follow-up with a high patient satisfaction rate .

###24243632
BACKGROUND	A single bout of exercise improves postprandial glycemia and insulin sensitivity in prediabetic patients ; however , the impact of exercise intensity is not well understood .
BACKGROUND	The present study compared the effects of acute isocaloric moderate ( MIE ) and high-intensity ( HIE ) exercise on glucose disposal and insulin sensitivity in prediabetic adults .
METHODS	Subjects ( n = 18 ; age 4914 y ; fasting glucose 10511 mg/dL ; 2 h glucose 17032 mg/dL ) completed a peak O2 consumption/lactate threshold ( LT ) protocol plus three randomly assigned conditions : 1 ) control , 1 hour of seated rest , 2 ) MIE ( at LT ) , and 3 ) HIE ( 75 % of difference between LT and peak O2 consumption ) .
METHODS	One hour after exercise , subjects received an oral glucose tolerance test ( OGTT ) .
METHODS	Plasma glucose , insulin , and C-peptide concentrations were sampled at 5 - to 10-minute intervals at baseline , during exercise , after exercise , and for 3 hours after glucose ingestion .
METHODS	Total , early-phase , and late-phase area under the glucose and insulin response curves were compared between conditions .
METHODS	Indices of insulin sensitivity ( SI ) were derived from OGTT data using the oral minimal model .
RESULTS	Compared with control , SI improved by 51 % ( P = .02 ) and 85 % ( P < .001 ) on the MIE and HIE days , respectively .
RESULTS	No differences in SI were observed between the exercise conditions ( P = .62 ) .
RESULTS	Improvements in SI corresponded to significant reductions in the glucose , insulin , and C-peptide area under the curve values during the late phase of the OGTT after HIE ( P < .05 ) , with only a trend for reductions after MIE .
CONCLUSIONS	These results suggest that in prediabetic adults , acute exercise has an immediate and intensity-dependent effect on improving postprandial glycemia and insulin sensitivity .

###24867693
BACKGROUND	Bleomycin-etoposid-cisplatin ( BEP ) chemotherapy is curative in most patients with disseminated germ cell cancer ( GCC ) but also associated with toxic actions and dysfunction in non-targeted tissues .
BACKGROUND	We investigated changes in muscle function during BEP and the safety and efficacy of resistance training to modulate these changes .
METHODS	Thirty GCC patients were randomly assigned to resistance training ( resistance training group ( INT ) , n = 15 ) or usual care ( CON , n = 15 ) during 9 weeks of BEP therapy .
METHODS	Resistance training consisted of thrice weekly sessions of four exercises , 3-4 sets/exercise of 10-15 repetitions at 12-15 repetition maximum load .
METHODS	The primary endpoint was muscle fibre size , assessed in muscle biopsies from musculus vastus lateralis .
METHODS	Secondary endpoints were fibre phenotype composition , body composition , strength , blood biochemistry and patient-reported endpoints .
METHODS	Healthy age-matched subjects ( REF , n = 19 ) performed the same RT-programme for comparison purposes .
RESULTS	Muscle fibre size decreased by -322 m ( 2 ) ( 95 % confidence interval ( CI ) : -899 to 255 ; P = 0.473 ) in the CON-group and increased by +206 m ( 2 ) ( 95 % CI : -384 to 796 ; P = 0.257 ) in the INT-group ( adjusted mean difference ( AMD ) , +625 m ( 2 ) , 95 % CI : -253 to 1503 , P = 0.149 ) .
RESULTS	Mean differences in type II fibre size ( AMD , +823 m ( 2 ) , P = 0.09 ) and lean mass ( AMD , +1.49 kg , P = 0.07 ) in favour of the INT-group approached significance .
RESULTS	The REF-group improved all muscular endpoints and had significantly superior changes compared with the INT-group ( P < 0.05 ) .
CONCLUSIONS	BEP was associated with significant reduction in lean mass and strength and trends toward unfavourable changes in muscle fibre size and phenotype composition .
CONCLUSIONS	Resistance training was safe and attenuated dysfunction in selected endpoints , but BEP blunted several positive adaptations observed in healthy controls .
CONCLUSIONS	Thus , our study does not support the general application of resistance training in this setting but larger-scaled trials are required to confirm this finding .

###25372450
OBJECTIVE	Purse-string suture is a closure method that purportedly reduces the scar area compared with second intention healing .
OBJECTIVE	Randomized clinical trials comparing these 2 methods appear to be limited or absent .
OBJECTIVE	To determine if purse-string suture improves cosmetic outcome , healing time , and scar to defect area compared with second intention healing for circular defects on the trunk and extremities .
METHODS	Prospective , 2-arm , randomized , evaluator-blinded clinical trial in a single-center outpatient academic dermatology center .
METHODS	Patients were eligible if they were older than 18 years , able to give informed consent , and had circular or oval postoperative defects larger than 8 mm on the trunk or extremities .
METHODS	For the purse-string treatment arm , wounds were sewn in circumferential fashion using polydiaxanone suture .
METHODS	Patients in the other treatment arm were allowed to heal by second intent .
METHODS	The primary outcome measures were the mean total Patient and Observer Scar Assessment Scale ( POSAS ) scores ascertained from the patient and 2 blinded observers .
METHODS	Secondary outcomes included the ratio of scar to initial defect size , healing time , pain scores , and complication rates .
RESULTS	Fifty-two patients were screened , and a total of 44 patients with 50 surgical sites were enrolled .
RESULTS	Forty-two patients with 48 surgical sites completed the study .
RESULTS	The mean total observer POSAS score was 18.38 for the purse-string group vs 19.91 for the secondary intention group , a nonsignificant difference ( P = .41 ) .
RESULTS	Similarly , there were no significant differences for any of the following secondary outcome measures : mean total patient POSAS score ( P = .96 ) , mean scar-to-defect area ( P = .61 ) , and mean pain level at week 1 ( P = .19 ) .
RESULTS	Statistical trends toward significance were seen in the mean healing time in favor of purse-string suture ( P = .10 ) and scar relief , which favored second intention healing ( P = .07 ) .
CONCLUSIONS	The purse-string suture results in similar cosmetic outcomes , scar sizes , and pain levels compared with second intention healing for circular or oval wounds on the trunk and extremities .
CONCLUSIONS	A larger study might better define the potential differences in our secondary outcome measures of healing time and scar relief .
BACKGROUND	clinicaltrials.gov Identifier : NCT02062866 .

###24490418
OBJECTIVE	To evaluate the effect of health education on prevention from schistosome infection in engineering construction workers in Poyang Lake area .
METHODS	The workers for constructing `` De Chang '' highway in Poyang Lake area were divided randomly into an experiment group and a control group , `` health education + protective skill training '' was carried out in the experiment group , whereas , no intervention was implemented in the control group .
RESULTS	In the experiment group , the awareness rates of schistosomiasis control knowledge were 7.96 % and 96.39 % before and after the intervention , respectively ; the rates of contacting infested water were 100 % and 1.77 % pre - and post-intervention , respectively ; the work protective rates increased from zero before the intervention to 100 % after the intervention ; there was no person infected with schistosome after the intervention .
RESULTS	However , in the control group , all the indexes above-mentioned had no significant changes .
CONCLUSIONS	The intervention model `` health education + protective skill training '' , can effectively prevent from schistosome infection in engineering construction workers in Poyang Lake area .

###25038293
BACKGROUND	Research has consistently identified a disparity between the prevalence of mental health concerns among young adults and their rates of formal help seeking .
BACKGROUND	However , a few randomised controlled trials have identified effective interventions for increasing formal help seeking among young adults .
BACKGROUND	The aim of this study was to evaluate the effectiveness of a brief online psychoeducational intervention , targeting depression , anxiety and suicide stigma , for increasing positive attitudes towards help seeking and increasing help seeking intentions among young adults .
METHODS	The study followed a single-blind parallel group randomized controlled trial design with 67 young adult ( 18-25 years ) Australian participants , assigned to receive online psychoeducation ( n = 33 ) or online attention-matched control information ( n = 34 ) over 3 weeks .
METHODS	Participants in the experimental group received information on depression , anxiety , and suicide .
METHODS	The control group received information unrelated to mental health .
METHODS	Primary outcome measures were mental health literacy , mental illness stigma , attitudes toward professional help seeking and intentions to seek help .
METHODS	Secondary outcome variables were symptomology , satisfaction and adherence .
RESULTS	Significant between-group differences were found for the pre - to post-test , including increased anxiety literacy ( Cohens d = 0.65 ) , decreased depression stigma ( d = 0.53 ) , and increased help seeking attitudes and intentions for the experimental group ( d = 0.58 and d = 0.53 , respectively ) .
CONCLUSIONS	Due to the small sample size and homogenous nature of the sample , generalisations should be made with caution .
CONCLUSIONS	This study demonstrates the utility and effectiveness of a brief online psychoeducation intervention for promoting help seeking among young adults .

###24259653
BACKGROUND	Antimicrobial pharmacokinetic and pharmacodynamic data are limited in obesity .
OBJECTIVE	To evaluate the steady-state pharmacokinetics and pharmacodynamics of doripenem and meropenem in obese patients hospitalized on a general ward .
METHODS	Patients with a body mass index ( BMI ) 40 kg/m or total body weight ( TBW ) 100 pounds over their ideal body weight randomly received doripenem 500 mg ( 1-hour infusion ) or meropenem 1 g ( 0.5-hour infusion ) every 8 hours .
METHODS	Differences in pharmacokinetic parameters were determined by unpaired t test .
METHODS	Monte Carlo simulations were performed for 500 mg and 1 g every 8 hours , infused over 1 and 4 hours for doripenem and 0.5 and 3 hours for meropenem .
METHODS	Probability of target attainment ( PTA ) was calculated using a pharmacodynamic target of 40 % fT > MIC ( free drug concentrations above the minimum inhibitory concentration [ MIC ] ) , and cumulative fraction of response ( CFR ) was calculated using MIC data for 8 Gram-negative pathogens .
RESULTS	Twenty patients were studied .
RESULTS	Volume of distribution at steady state , corrected for TBW , was significantly larger ( 0.18 0.04 vs 0.13 0.05 L/kg , P = .048 ) and systemic clearance was significantly faster for doripenem ( 11.7 4.1 vs 8.1 2.6 L/h , P = .03 ) .
RESULTS	PTA was > 90 % for all regimens at MICs 2 g/mL .
RESULTS	CFR was > 90 % for all regimens against 6 enteric Gram-negative pathogens and for 3 of 4 regimens for each drug against Pseudomonas aeruginosa .
CONCLUSIONS	Doripenem and meropenem pharmacokinetics differ in obesity .
CONCLUSIONS	However , currently approved dosing regimens provide adequate pharmacodynamic exposures for susceptible bacteria in obese patients .

###25128296
BACKGROUND	Increased circulating cathepsin S levels have been linked to increased risk of cardiometabolic diseases and cancer .
BACKGROUND	However , whether cathepsin S is a modifiable risk factor is unclear .
BACKGROUND	We aimed to investigate the effects of a prudent diet on plasma cathepsin S levels in healthy individuals .
RESULTS	Explorative analyses of a randomized study were performed in 88 normal to slightly overweight and hyperlipidemic men and women ( aged 25 to 65 ) that were randomly assigned to ad libitum prudent diet , i.e. healthy Nordic diet ( ND ) or a control group ( habitual Western diet ) for 6weeks .
RESULTS	Whereas all foods in the ND were provided , the control group was advised to consume their habitual diet throughout the study .
RESULTS	The ND was in line with dietary recommendations , e.g. low in saturated fats , sugars and salt , but high in plant-based foods rich in fibre and unsaturated fats.The ND significantly decreased cathepsin S levels ( from 20.1 ( + / -4.0 SD ) to 19.7 g/L ( + / -4.3 SD ) ) compared with control group ( from 18.2 ( + / -2.9 SD ) to 19.1 g/L ( + / -3.8 SD ) ) .
RESULTS	This difference remained after adjusting for sex and change in insulin sensitivity ( P = 0.03 ) , and near significant after adjusting for baseline cathepsin S levels ( P = 0.06 ) , but not for change in weight or LDL-C .
RESULTS	Changes in cathepsin S levels were directly correlated with change in LDL-C .
CONCLUSIONS	Compared with a habitual control diet , a provided ad libitum healthy Nordic diet decreased cathepsin S levels in healthy individuals , possibly mediated by weight loss or lowered LDL-C .
CONCLUSIONS	These differences between groups in cathepsin S were however not robust and therefore need further investigation .

###25951477
OBJECTIVE	The purpose of the study was to assess what effect daily cleaning of contact lenses with a multipurpose disinfection solution ( MPDS ) , during 30 nights extended wear , would have on contact lens-related adverse events .
METHODS	This was a prospective , open-label , randomized , controlled , parallel-group , 3-month clinical study in which 193 participants were dispensed with lotrafilcon A silicone hydrogel lenses for a 30-day extended-wear schedule and with lenses replaced monthly .
METHODS	Participants were randomized to a control or test group .
METHODS	Test subjects were required to remove lenses daily after waking , clean them with the MPDS , and reinsert the lenses .
METHODS	Control subjects wore lenses without removal for 30 days extended wear .
METHODS	Handling-related lens contamination was assessed at the baseline visit .
RESULTS	There was no significant difference between the test and control groups for the incidence of significant corneal infiltrative events ( 1.3 vs. 4.9 % , p = 0.368 ) , total corneal infiltrative events ( 2.6 vs. 4.9 % , p = 0.682 ) , or mechanical events ( 1.3 vs. 2.5 % , p = 1.00 ) .
RESULTS	The test group had greater corneal staining ( p < 0.047 ) and fewer mucin balls ( p = 0.033 ) .
RESULTS	Handling-related lens contamination ( unworn lenses ) resulted in isolation of Gram-positive bacteria from 92.5 % of test lenses compared with 87.5 % of control lenses ( p = 0.712 ) .
RESULTS	Gram-negative bacteria were isolated from 5 % of test subjects compared with 2.5 % of control subjects ( p = 1.00 ) .
RESULTS	Fungus was isolated from 2.5 % of subjects in both the test and control groups ( p = 1.00 ) .
CONCLUSIONS	The intervention of daily morning cleaning of the lens surface with an MPDS during extended wear did not significantly influence the incidence of adverse events .

###24398815
BACKGROUND	For economic reasons , i.e. , to reduce costs of in-hospital patient accommodations , constant pressure has been applied in recent years to increase the percentage of ambulatory surgeries .
BACKGROUND	Effective control of post-operative pain after ambulatory surgery is challenging to all health professionals .
BACKGROUND	Computerised systems are being implemented more frequently for remote patient monitoring , including during the at-home post-operative period .
OBJECTIVE	This study evaluates the feasibility of delivering a computerised system , developed in-house , for remote pain monitoring .
OBJECTIVE	It evaluates the user-friendliness of the system and the extent of patient compliance .
OBJECTIVE	Finally , a comparative assessment of the system is made with respect to the quality of pain treatment in ambulatory surgery .
METHODS	The participants included 32 adults , aged 18-75 , randomly assigned to a control group or to a computerised treatment group .
METHODS	The primary treatment outcome was measured by pain intensity ratings ( 0-10 NRS ) reported several times per day during a five-day monitoring period , using an electronic pain diary combined with a web-based personal health record .
CONCLUSIONS	The findings demonstrated the feasibility and suitability of the proposed system for pain management .
CONCLUSIONS	Its handling was user-friendly , without requiring advanced skill or prior experience .
CONCLUSIONS	In addition , the results showed that the guidance of health care professionals is essential to patients ' satisfaction and positive experience with the system .
CONCLUSIONS	There were no significant group differences with respect to improvements in the quality of pain treatment ; however , this can be explained by the low pain scores registered in both groups , related to the type of surgical interventions recruited and the degrees of pain that are easily treated .
CONCLUSIONS	To evaluate the benefits from a patient-centred perspective , studies of major ambulatory surgeries or of patients in chronic pain , including oncologic and non-oncologic pain resistant to treatment , are necessary .

###24351147
BACKGROUND	A wide variety of orthodontic wires made of different alloys is available to be used in orthodontic practice and may produce different clinical responses during tooth movement .
OBJECTIVE	This research evaluated the alignment and leveling of lower dental arches after the use of three types of orthodontic wires .
METHODS	A sample of 36 patients was randomly divided into 3 groups : stainless steel , multistranded steel and superelastic nickel-titanium , according to the first leveling arches used .
METHODS	In order to observe differences in tooth position and axial inclination of the lower incisors , all patients had lateral cephalometric radiographs taken before the insertion of the first arches and 2 months later .
METHODS	The irregularity index and the curve of Spee were measured , compared between groups and considered influential on the proclination of incisors during the initial phase of alignment and leveling .
METHODS	TheReflex microscope was used to measure the irregularity index , whereas the ANOVA analysis of variance was used to verify differences between groups with regard to the degree of dental alignment and leveling .
RESULTS	There were significant differences between groups only at T2 for the irregularity index .
CONCLUSIONS	The NiTi and multistranded steel wires showed greater aligning capacity when compared with stainless steel wires .

###24789702
OBJECTIVE	The objectives of this study are to compare the effects of two nursing intervention models on the ability of preschool children with malignant tumors to socialize and to determine if these interventions improved their social adaption capability ( SAC ) and quality of life .
METHODS	Inpatient preschool children with malignant tumors admitted to the hospital between December 2009 and March 2012 were recruited and randomized into either the experimental or control groups .
METHODS	The control group received routine nursing care , and the experimental group received family-centered nursing care , including physical , psychological , and social interventions .
METHODS	The Infants-Junior Middle School Student 's Social-Life Abilities Scale was used to evaluate SAC development of participants .
RESULTS	Participants ( n = 240 ) were recruited and randomized into two groups .
RESULTS	After the intervention , the excellent and normal SAC rates were 27.5 % and 55 % in the experimental group , respectively , compared with 2.5 % and 32.5 % in the control group ( p < 0.001 ) .
RESULTS	After the intervention , SAC in experimental group was improved compared with before intervention ( 54.6810.85 vs 79.922.3 , p < 0.001 ) .
RESULTS	However , no differences in SAC were observed between baseline and after intervention in the control group ( 54.7011.47 vs. 5215.8 , p = 0.38 ) .
CONCLUSIONS	The family-centered nursing care model that included physical , psychological , and social interventions improved the SAC of children with malignancies compared with children receiving routine nursing care .
CONCLUSIONS	Establishing a standardized family-school-community-hospital hierarchical multi-management intervention model for children is important to the efficacy of long-term interventions and to the improvement of SAC of children with malignancies .

###25774645
BACKGROUND	Most trials comparing percutaneous coronary intervention ( PCI ) with coronary-artery bypass grafting ( CABG ) have not made use of second-generation drug-eluting stents .
METHODS	We conducted a randomized noninferiority trial at 27 centers in East Asia .
METHODS	We planned to randomly assign 1776 patients with multivessel coronary artery disease to PCI with everolimus-eluting stents or to CABG .
METHODS	The primary end point was a composite of death , myocardial infarction , or target-vessel revascularization at 2 years after randomization .
METHODS	Event rates during longer-term follow-up were also compared between groups .
RESULTS	After the enrollment of 880 patients ( 438 patients randomly assigned to the PCI group and 442 randomly assigned to the CABG group ) , the study was terminated early owing to slow enrollment .
RESULTS	At 2 years , the primary end point had occurred in 11.0 % of the patients in the PCI group and in 7.9 % of those in the CABG group ( absolute risk difference , 3.1 percentage points ; 95 % confidence interval [ CI ] , -0.8 to 6.9 ; P = 0.32 for noninferiority ) .
RESULTS	At longer-term follow-up ( median , 4.6 years ) , the primary end point had occurred in 15.3 % of the patients in the PCI group and in 10.6 % of those in the CABG group ( hazard ratio , 1.47 ; 95 % CI , 1.01 to 2.13 ; P = 0.04 ) .
RESULTS	No significant differences were seen between the two groups in the occurrence of a composite safety end point of death , myocardial infarction , or stroke .
RESULTS	However , the rates of any repeat revascularization and spontaneous myocardial infarction were significantly higher after PCI than after CABG .
CONCLUSIONS	Among patients with multivessel coronary artery disease , the rate of major adverse cardiovascular events was higher among those who had undergone PCI with the use of everolimus-eluting stents than among those who had undergone CABG .
CONCLUSIONS	( Funded by CardioVascular Research Foundation and others ; BEST ClinicalTrials.gov number , NCT00997828 . )

###25847979
BACKGROUND	There is a paucity of data on the use of optimal medical therapy ( OMT ) in patients with complex coronary artery disease undergoing revascularization with percutaneous coronary intervention or coronary artery bypass grafting ( CABG ) and its long-term prognostic significance .
RESULTS	The Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery ( SYNTAX ) trial is a multicenter , randomized , clinical trial of patients ( n = 1800 ) with complex coronary disease randomized to revascularization with percutaneous coronary intervention or CABG .
RESULTS	Detailed drug history was collected for all patients at discharge and at the 1-month , 6-month , 1-year , 3-year , and 5-year follow-ups .
RESULTS	OMT was defined as the combination of at least 1 antiplatelet drug , statin , - blocker , and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker .
RESULTS	Five-year clinical outcomes were stratified by OMT and non-OMT .
RESULTS	OMT was underused in patients treated with coronary revascularization , especially CABG .
RESULTS	OMT was an independent predictor of survival .
RESULTS	OMT was associated with a significant reduction in mortality ( hazard ratio , 0.64 ; 95 % confidence interval , 0.48-0 .85 ; P = 0.002 ) and composite end point of death/myocardial infarction/stroke ( hazard ratio , 0.73 ; 95 % confidence interval , 0.58-0 .92 ; P = 0.007 ) at the 5-year follow-up .
RESULTS	The treatment effect with OMT ( 36 % relative reduction in mortality over 5 years ) was greater than the treatment effect of revascularization strategy ( 26 % relative reduction in mortality with CABG versus percutaneous coronary intervention over 5 years ) .
RESULTS	On stratified analysis , all the components of OMT were important for reducing adverse outcomes regardless of revascularization strategy .
CONCLUSIONS	The use of OMT remains low in patients with complex coronary disease requiring coronary intervention with percutaneous coronary intervention and even lower in patients treated with CABG .
CONCLUSIONS	Lack of OMT is associated with adverse clinical outcomes .
CONCLUSIONS	Targeted strategies to improve OMT use in postrevascularization patients are warranted .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00114972 .

###25788018
OBJECTIVE	To determine whether an education programme targeted at schoolchildren could lower salt intake in children and their families .
METHODS	Cluster randomised controlled trial , with schools randomly assigned to either the intervention or control group .
METHODS	28 primary schools in urban Changzhi , northern China .
METHODS	279 children in grade 5 of primary school , with mean age of 10.1 ; 553 adult family members ( mean age 43.8 ) .
METHODS	Children in the intervention group were educated on the harmful effects of salt and how to reduce salt intake within the schools ' usual health education lessons .
METHODS	Children then delivered the salt reduction message to their families .
METHODS	The intervention lasted for one school term ( about 3.5 months ) .
METHODS	The primary outcome was the difference between the groups in the change in salt intake ( as measured by 24 hour urinary sodium excretion ) from baseline to the end of the trial .
METHODS	The secondary outcome was the difference between the two groups in the change in blood pressure .
RESULTS	At baseline , the mean salt intake in children was 7.3 ( SE 0.3 ) g/day in the intervention group and 6.8 ( SE 0.3 ) g/day in the control group .
RESULTS	In adult family members the salt intakes were 12.6 ( SE 0.4 ) and 11.3 ( SE 0.4 ) g/day , respectively .
RESULTS	During the study there was a reduction in salt intake in the intervention group , whereas in the control group salt intake increased .
RESULTS	The mean effect on salt intake for intervention versus control group was -1.9 g/day ( 95 % confidence interval -2.6 to -1.3 g/day ; P < 0.001 ) in children and -2.9 g/day ( -3.7 to -2.2 g/day ; P < 0.001 ) in adults .
RESULTS	The mean effect on systolic blood pressure was -0.8 mm Hg ( -3.0 to 1.5 mm Hg ; P = 0.51 ) in children and -2.3 mm Hg ( -4.5 to -0.04 mm Hg ; P < 0.05 ) in adults .
CONCLUSIONS	An education programme delivered to primary school children as part of the usual curriculum is effective in lowering salt intake in children and their families .
CONCLUSIONS	This offers a novel and important approach to reducing salt intake in a population in which most of the salt in the diet is added by consumers.Trial registration ClinicalTrials.gov NCT01821144 .

###25043631
BACKGROUND	Arthritis and musculoskeletal conditions are the leading cause of long-term work disability ( WD ) , an outcome with a major impact on quality of life and a high cost to society .
BACKGROUND	The importance of decreased at-work productivity has also recently been recognized .
BACKGROUND	Despite the importance of these problems , few interventions have been developed to reduce the impact of arthritis on employment .
BACKGROUND	We have developed a novel intervention called `` Making It Work '' , a program to help people with inflammatory arthritis ( IA ) deal with employment issues , prevent WD and improve at-work productivity .
BACKGROUND	After favorable results in a proof-of-concept study , we converted the program to a web-based format for broader dissemination and improved accessibility .
BACKGROUND	The objectives of this study are : 1 ) to evaluate in a randomized controlled trial ( RCT ) the effectiveness of the program at preventing work cessation and improving at-work productivity ; 2 ) to perform a cost-utility analysis of the intervention .
METHODS	526 participants with IA will be recruited from British Columbia , Alberta , and Ontario in Canada .
METHODS	The intervention consists of a ) 5 online group sessions ; b ) 5 web-based e-learning modules ; c ) consultations with an occupational therapist for an ergonomic work assessment and a vocational rehabilitation counselor .
METHODS	Questionnaires will be administered online at baseline and every 6months to collect information about demographics , disease measures , costs , work-related risk factors for WD , quality of life , and work outcomes .
METHODS	Primary outcomes include at-work productivity and time to work cessation of > 6months for any reason .
METHODS	Secondary outcomes include temporary work cessation , number of days missed from work per year , reduction in hours worked per week , quality adjusted life year for the cost utility analysis , and changes from baseline in employment risk factors .
METHODS	Analysis of Variance will evaluate the intervention 's effect on at-work productivity , and multivariable Cox regression models will estimate the risk of work cessation associated with the intervention after controlling for risk factors for WD and other important predictors imbalanced at baseline .
CONCLUSIONS	This program fills an important gap in arthritis health services and addresses an important and costly problem .
CONCLUSIONS	Knowledge gained from the RCT will be useful to health care professionals , policy planners and arthritis stakeholders .
BACKGROUND	ClinicalTrials.gov NCT01852851 ; registered April 13 , 2012 ; first participant randomized on July 6 , 2013 .

###24800342
BACKGROUND	Closure of abdominal incisions with different suture materials has been a matter of great controversy .
BACKGROUND	Polypropylene and Polylactide with Polyglycolide are among the commonest suture materials used for closure of abdominal incisions .
BACKGROUND	Objectives of this study were to assess optimal suture material used for closure of elective abdominal incisions and to see complications associated with these suture materials .
METHODS	This prospective , comparative , randomised study was conducted at public and private sector hospitals of Nawabshah and Hyderabad from 1st Jan 2005 to 31st October 2009 .
METHODS	All patients who underwent abdominal surgery under the investigators ' supervision were included in the study .
METHODS	Patients were divided into 2 groups on even or odd numbers .
METHODS	In group-A patients ' incision was closed with monofilament , non-absorbable Polypropylene ( Prolene ) No. 1 suture material and in group-B incision was closed with Polyfilament , absorbable , co-polymer of Polylactide with Polyglycolide ( Vicryle ) No. 1 .
RESULTS	A total 274 patients were finally analysed for closure of elective abdominal incisions , with 138 ( 50.4 % ) patients in Group-A and 136 ( 49.6 % ) patients in Group-B .
RESULTS	Vicryle was found superior in knot security and suture handling .
RESULTS	Superficial wound infection was found in 5.79 % patients of Group-A and 6.61 % of Group-B .
RESULTS	Discharging sinus was found in 3.62 % of Group-A vs 0.73 % of Group-B .
RESULTS	Burst abdomen was seen in 2.17 % patients in Group-A and 1.47 % in Group-B .
RESULTS	Incisional hernia was present in 4.34 % of Group-A and 0.73 % patients of Group-B .
RESULTS	No patient in Group-B developed persistent pain at incisional site while it was found in 8.69 % patients of Group-A .
CONCLUSIONS	Polylactide is an optimal suture material in closure of elective abdominal incisions .

###24345444
OBJECTIVE	Memantine , an uncompetitive N-methyl-d-aspartate receptor antagonist , is currently approved by the US Food and Drug Administration for the treatment of moderate to severe Alzheimer 's disease .
OBJECTIVE	Anecdotal reports have suggested that memantine may improve neurologic and cognitive symptoms of individuals with the neurodegenerative disease fragile X-associated tremor/ataxia syndrome ( FXTAS ) ; however , its efficacy and safety in this population have not been assessed in a controlled trial .
METHODS	Individuals with FXTAS aged 34-80 years were enrolled in a randomized , double-blind , placebo-controlled , 1-year trial between September 2007 and August 2012 .
METHODS	Inclusion required definite , probable , or possible FXTAS in clinical stages 1-5 according to previously published criteria .
METHODS	Primary outcome measures were the Behavioral Dyscontrol Scale ( BDS ) score and CATSYS intention tremor severity .
RESULTS	Ninety-four participants were randomized from 205 screened ; of those , 43 and 45 started treatment with memantine ( titrated to 10 mg twice daily ) and placebo , respectively .
RESULTS	Thirty-four participants receiving memantine and 36 receiving placebo completed the 1-year endpoint assessment ( n = 70 ) .
RESULTS	Intention-to-treat analysis showed no improvement with respect to intention tremor severity ( mean [ SD ] values with memantine vs placebo : 1.05 [ 0.73 ] vs 1.89 [ 2.19 ] , P = .047 ) or BDS score ( 16.12 [ 5.43 ] vs 15.72 [ 3.93 ] , P = .727 ) at follow-up .
RESULTS	Post hoc analyses of participants with early FXTAS ( stage 3 ) , those with late FXTAS ( stage > 3 ) , and those in different age groups ( 65 years and > 65 years ) also indicated no significant improvement .
RESULTS	More frequent mild adverse events were observed in the placebo group , while more frequent moderate adverse events occurred in the memantine group ( P = .007 ) .
CONCLUSIONS	This randomized , double-blind , placebo-controlled trial of memantine for individuals with FXTAS showed no benefit compared to placebo with respect to the selected outcome measures .
BACKGROUND	ClinicalTrials.gov identifier : NCT00584948 .

###25394805
BACKGROUND	Falling can lead to severe health issues in the elderly and importantly contributes to morbidity , death , immobility , hospitalization , and early entry to long-term care facilities .
BACKGROUND	The aim of this study was to devise a recurrent fall prevention program for elderly women in rural areas .
METHODS	This study adopted an assessor-blinded , randomized , controlled trial methodology .
METHODS	Subjects were enrolled in a 12-week recurrent fall prevention program , which comprised strength training , balance training , and patient education .
METHODS	Muscle strength and endurance of the ankles and the lower extremities , static balance , dynamic balance , depression , compliance with preventive behavior related to falls , fear of falling , and fall self-efficacy at baseline and immediately after the program were assessed .
METHODS	Sixty-two subjects ( mean age 69.24.3 years old ) completed the program -- 31 subjects in the experimental group and 31 subjects in the control group .
RESULTS	When the results of the program in the 2 groups were compared , significant differences were found in ankle heel rise test , lower extremity heel rise test , dynamic balance , depression , compliance with fall preventative behavior , fear of falling , and fall self-efficacy ( p < 0.05 ) , but no significant difference was found in static balance .
CONCLUSIONS	This study shows that the fall prevention program described effectively improves muscle strength and endurance , balance , and psychological aspects in elderly women with a fall history .

###26165003
OBJECTIVE	To study the diagnostic importance of a new Indis software package for the postprocessing of the results of radionuclude examinations ( Center for Information and Diagnostic Systems , St. Petersburg , Russia ) when analyzing the results of lacrimal scintigraphy .
METHODS	Dynamic lacrimal scintigraphy was carried out in 6 volunteers ( 12 eyes ) and 20 patients ( 32 years ) with dacryostenosis .
METHODS	The examined Indis program and the known Syngo program ( Siemens , Germany ) were used to calculate the elimination half-life of a radiopharmaceutical from the interest region corresponding to the whole ocular surface .
METHODS	The time taken to postprocess the results of the examination was also determined .
RESULTS	When calculations were made using the Indis program and the Syngo system , the elimination half-lives of a tracer in the volunteers was 6.57 2.46 and 7.54 3.21 min , respectively .
RESULTS	These in the patents with dacryostenosis were 69.39 65.52 and 74.85 64.59 min .
RESULTS	With these programs , the times taken for postprocessing were 12.3 4.2 and 26.3 7.9 min , respectively .
CONCLUSIONS	The investigation showed the practical significance of the Indis software package in processing the data of lacrimal scintigraphy .
CONCLUSIONS	The calculations made with the Indis program correspond to those made with the known Syngo program .
CONCLUSIONS	The convenience and ergonomics of the program can precisely identify the region of interest .
CONCLUSIONS	The economic justification of the system is associated with the shorter time taken to postprocess and interpret the results of lacrimal scintigraphy .
CONCLUSIONS	The Indis software package may be recommended for use in the examination and treatment monitoring in patients with abnormal lacrimaton .

###24724878
OBJECTIVE	This study examined in - and post-treatment mediation effects of a 12-session dose of Seeking Safety ( SS ) - an integrative cognitive behavioral treatment for comorbid PTSD and SUDs-on alcohol and cocaine outcomes in comparison to Women 's Health Education ( WHE ) in a seven-site randomized controlled effectiveness trial .
METHODS	Women ( n = 353 ) enrolled in outpatient substance abuse treatment , who had experienced multiple traumas in childhood and/or adulthood and who had comorbid PTSD , were randomly assigned to receive SS or WHE delivered in open enrollment groups for 12 sessions in 6 weeks ( unlike the full 25-topic SS protocol ) .
METHODS	Data were analyzed under two forms of longitudinal mediation analysis , each accounting for changes over time in group membership and group context , respectively .
RESULTS	Women in SS , compared to WHE , showed significantly steeper decreases in PTSD frequency and severity , which in turn , showed significant impact in reducing both cocaine and alcohol use .
RESULTS	This pattern was strongest for those who completed most of the treatment sessions , which was the majority of patients in the trial ; these patterns only emerged during the in-treatment phase .
CONCLUSIONS	Use of an integrated approach to PTSD/SUD such as SS can be helpful to more rapidly reduce PTSD , which consequently reduce SUD symptoms , particularly for those who attend most of the available treatment sessions .
CONCLUSIONS	This is one of the first studies to illustrate such effects in treating comorbid PTSD and SUD in the context of a highly impaired population delivered by community-based providers .
CONCLUSIONS	( Am J Addict 2014 ; 23:218 -225 ) .

###24597596
BACKGROUND	Ivabradine is a negative chronotropic drug with minimal effects on central hemodynamics .
BACKGROUND	Its effect on dynamic obstruction of the left ventricular outflow tract ( LVOT ) in cats with hypertrophic cardiomyopathy ( HCM ) remains unknown .
OBJECTIVE	Ivabradine reduces dynamic obstruction of the LVOT in cats with HCM .
METHODS	Twenty-eight client-owned cats with preclinical HCM and dynamic LVOT obstruction .
METHODS	Randomized , double-blind , active-control single dose study .
METHODS	Cats received a single dose of either ivabradine ( 0.3 mg/kg PO ) or atenolol ( 2 mg/kg PO ) .
METHODS	Heart rate , echocardiographic variables , and systolic blood pressure ( SBP ) were recorded before and 3 hours after drug administration .
METHODS	Statistical comparisons were made using ANCOVA .
RESULTS	Peak velocity in the LVOT was significantly decreased compared to baseline for both drugs ; however , the effect was more prominent with atenolol ( mean reduction 2.53 m/s ; 95 % CI 2.07-3 .13 m/s ) compared to ivabradine ( mean reduction 0.32 m/s ; 95 % CI -0.04 to 0.71 m/s ; P < .0001 ) .
RESULTS	Echocardiographic indices of systolic function were largely unchanged by ivabradine , but significantly reduced by atenolol .
CONCLUSIONS	A single dose of ivabradine decreases dynamic LVOT obstruction in cats with HCM , but the clinical effect is negligible and inferior compared to that achieved by atenolol .

###24965385
BACKGROUND	Age-related macular degeneration ( AMD ) is the leading cause of blindness among older adults in the developed world .
BACKGROUND	The only treatments currently available , such as ranibizumab injections , are for neovascular AMD , which accounts for only 10 to 15 % of people with the condition .
BACKGROUND	Hypoxia has been implicated as one of the primary causes of AMD , and is most acute at night when the retina is most metabolically active .
BACKGROUND	By increasing light levels at night , the metabolic requirements of the retina and hence the hypoxia will be considerably reduced .
BACKGROUND	This trial seeks to determine whether wearing a light mask that emits a dim , green light during the night can prevent the progression of early AMD .
METHODS	ALight is a Phase I/IIa , multicentre , randomized controlled trial .
METHODS	Sixty participants ( 55 to 88years old ) with early AMD in one eye and neovascular AMD ( nAMD ) in the fellow eye will be recruited from nAMD clinics .
METHODS	They will be randomized ( in the ratio 1:1 ) , either to receive the intervention or to be in the untreated control group , stratified according to risk of disease progression .
METHODS	An additional 40 participants with healthy retinal appearance , or early AMD only , will be recruited for a baseline cross-sectional analysis .
METHODS	The intervention is an eye mask that emits a dim green light to illuminate the retina through closed eyelids at night .
METHODS	This is designed to reduce the metabolic activity of the retina , thereby reducing the potential risk of hypoxia .
METHODS	Participants will wear the mask every night for 12months .
METHODS	Ophthalmologists carrying out monthly assessments will be masked to the treatment group , but participants will be aware of their treatment group .
METHODS	The primary outcome measure is the proportion of people who show disease progression during the trial period in the eye with early AMD .
METHODS	A co-primary outcome measure is the rate of retinal adaptation .
METHODS	As this is a trial of a CE-marked device for an off-label indication , a further main aim of this trial is to assess safety of the mask in the cohort of participants with AMD .
BACKGROUND	International Standard Randomised Controlled Trials Register : ISRCTN82148651 .

###26132941
BACKGROUND	Erythropoietic protoporphyria is a severe photodermatosis that is associated with acute phototoxicity .
BACKGROUND	Patients with this condition have excruciating pain and a markedly reduced quality of life .
BACKGROUND	We evaluated the safety and efficacy of an - melanocyte-stimulating hormone analogue , afamelanotide , to decrease pain and improve quality of life .
METHODS	We conducted two multicenter , randomized , double-blind , placebo-controlled trials of subcutaneous implants containing 16 mg of afamelanotide .
METHODS	Patients in the European Union ( 74 patients ) and the United States ( 94 patients ) were randomly assigned , in a 1:1 ratio , to receive a subcutaneous implant containing either afamelanotide or placebo every 60 days ( a total of five implants in the European Union study and three in the U.S study ) .
METHODS	The type and duration of sun exposure , number and severity of phototoxic reactions , and adverse events were recorded over the respective 180-day and 270-day study periods .
METHODS	Quality of life was assessed with the use of validated questionnaires .
METHODS	A subgroup of U.S. patients underwent photoprovocation testing .
METHODS	The primary efficacy end point was the number of hours of direct exposure to sunlight without pain .
RESULTS	In the U.S. study , the duration of pain-free time after 6 months was longer in the afamelanotide group ( median , 69.4 hours , vs. 40.8 hours in the placebo group ; P = 0.04 ) .
RESULTS	In the European Union study , the duration of pain-free time after 9 months was also longer in the afamelanotide group than in the placebo group ( median , 6.0 hours vs. 0.8 hours ; P = 0.005 ) , and the number of phototoxic reactions was lower in the the afamelanotide group ( 77 vs. 146 , P = 0.04 ) .
RESULTS	In both trials , quality of life improved with afamelanotide therapy .
RESULTS	Adverse events were mostly mild ; serious adverse events were not thought to be related to the study drug .
CONCLUSIONS	Afamelanotide had an acceptable side-effect and adverse-event profile and was associated with an increased duration of sun exposure without pain and improved quality of life in patients with erythropoietic protoporphyria .
CONCLUSIONS	( Funded by Clinuvel Pharmaceuticals and others ; ClinicalTrials.gov numbers , NCT01605136 and NCT00979745 . )

###25012235
BACKGROUND	Mild head injuries commonly present to emergency departments .
BACKGROUND	The challenges facing clinicians in emergency departments include identifying which patients have traumatic brain injury , and which patients can safely be sent home .
BACKGROUND	Traumatic brain injuries may exist with subtle symptoms or signs , but can still lead to adverse outcomes .
BACKGROUND	Despite the existence of several high quality clinical practice guidelines , internationally and in Australia , research shows inconsistent implementation of these recommendations .
BACKGROUND	The aim of this trial is to test the effectiveness of a targeted , theory - and evidence-informed implementation intervention to increase the uptake of three key clinical recommendations regarding the emergency department management of adult patients ( 18years of age or older ) who present following mild head injuries ( concussion ) , compared with passive dissemination of these recommendations .
BACKGROUND	The primary objective is to establish whether the intervention is effective in increasing the percentage of patients for which appropriate post-traumatic amnesia screening is performed .
METHODS	The design of this study is a cluster randomised trial .
METHODS	We aim to include 34 Australian 24-hour emergency departments , which will be randomised to an intervention or control group .
METHODS	Control group departments will receive a copy of the most recent Australian evidence-based clinical practice guideline on the acute management of patients with mild head injuries .
METHODS	The intervention group will receive an implementation intervention based on an analysis of influencing factors , which include local stakeholder meetings , identification of nursing and medical opinion leaders in each site , a train-the-trainer day and standardised education and interactive workshops delivered by the opinion leaders during a 3month period of time .
METHODS	Clinical practice outcomes will be collected retrospectively from medical records by independent chart auditors over the 2month period following intervention delivery ( patient level outcomes ) .
METHODS	In consenting hospitals , eligible patients will be recruited for a follow-up telephone interview conducted by trained researchers .
METHODS	A cost-effectiveness analysis and process evaluation using mixed-methods will be conducted .
METHODS	Sample size calculations are based on including 30 patients on average per department .
METHODS	Outcome assessors will be blinded to group allocation .
BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12612001286831 ( date registered 12 December 2012 ) .

###24817827
BACKGROUND	The population of obese patients is progressively growing and bariatric operations are becoming increasingly common .
BACKGROUND	Morbidly obese patients require special anesthetic care and are often considered to be difficult to ventilate and intubate .
BACKGROUND	The VivaSight Single Lumen tube is an endotracheal tube with a camera embedded in its tip .
BACKGROUND	The view from the tip appears continuously on a monitor in the anesthesiologist 's vicinity .
BACKGROUND	The aim of this study was to assess the VivaSight in comparison with conventional endotracheal tube as an aid in the intubation and surveillance of tube position during surgery of obese patients .
METHODS	This is a prospective study of 72 adult obese patients who underwent laparoscopic sleeve gastrectomy .
METHODS	The patients were randomly assigned to be intubated by either the VivaSight ( 40 patients , test group ) or a conventional endotracheal tube ( 32 patients , control group ) .
METHODS	Data on the patients , the pre-operative airway evaluation , the endotracheal intubation and the post-operative outcome were collected and compared .
RESULTS	The Mallampati scores were significantly higher in the test group than in the control group .
RESULTS	Endotracheal intubation took 2910 and 248seconds using the VivaSight and a conventional tube respectively ( p = 0.02 ) .
RESULTS	Three of the patients in the control group , while none of those in the test group , had soft tissue injury ( p < 0.05 ) .
CONCLUSIONS	We found the VivaSight SL to be helpful in the endotracheal intubation and continuous surveillance of tube position in morbidly obese patients undergoing laparoscopic sleeve gastrectomy .

###25923550
BACKGROUND	Non-small-cell lung cancer ( NSCLC ) with a mutation in the gene encoding epidermal growth factor receptor ( EGFR ) is sensitive to approved EGFR inhibitors , but resistance develops , mediated by the T790M EGFR mutation in most cases .
BACKGROUND	Rociletinib ( CO-1686 ) is an EGFR inhibitor active in preclinical models of EGFR-mutated NSCLC with or without T790M .
METHODS	In this phase 1-2 study , we administered rociletinib to patients with EGFR-mutated NSCLC who had disease progression during previous treatment with an existing EGFR inhibitor .
METHODS	In the expansion ( phase 2 ) part of the study , patients with T790M-positive disease received rociletinib at a dose of 500 mg twice daily , 625 mg twice daily , or 750 mg twice daily .
METHODS	Key objectives were assessment of safety , side-effect profile , pharmacokinetics , and preliminary antitumor activity of rociletinib .
METHODS	Tumor biopsies to identify T790M were performed during screening .
METHODS	Treatment was administered in continuous 21-day cycles .
RESULTS	A total of 130 patients were enrolled .
RESULTS	The first 57 patients to be enrolled received the free-base form of rociletinib ( 150 mg once daily to 900 mg twice daily ) .
RESULTS	The remaining patients received the hydrogen bromide salt ( HBr ) form ( 500 mg twice daily to 1000 mg twice daily ) .
RESULTS	A maximum tolerated dose ( the highest dose associated with a rate of dose-limiting toxic effects of less than 33 % ) was not identified .
RESULTS	The only common dose-limiting adverse event was hyperglycemia .
RESULTS	In an efficacy analysis that included patients who received free-base rociletinib at a dose of 900 mg twice daily or the HBr form at any dose , the objective response rate among the 46 patients with T790M-positive disease who could be evaluated was 59 % ( 95 % confidence interval [ CI ] , 45 to 73 ) , and the rate among the 17 patients with T790M-negative disease who could be evaluated was 29 % ( 95 % CI , 8 to 51 ) .
CONCLUSIONS	Rociletinib was active in patients with EGFR-mutated NSCLC associated with the T790M resistance mutation .
CONCLUSIONS	( Funded by Clovis Oncology ; ClinicalTrials.gov number , NCT01526928 . )

###25580697
OBJECTIVE	Although pain in knee osteoarthritis ( OA ) commonly affects activity engagement , the daily pain experience has not been fully characterized .
OBJECTIVE	Specifically , the nature and impact of pain flares is not well understood .
OBJECTIVE	This study characterized pain flares as defined by participants with knee OA .
OBJECTIVE	Pain flare occurrence and experience were measured over 7 days .
METHODS	This was a multiple methods study ; qualitative methods were dominant .
METHODS	Data were collected during the baseline portion of a randomized controlled trial .
METHODS	Participants met criteria for knee OA and had moderate to severe pain .
METHODS	They completed questionnaires and a 7-day home monitoring period that captured momentary symptom reports simultaneously with physical activity via accelerometry ( n = 45 ) .
METHODS	Participants also provided individual definitions of pain flare that were used throughout the home monitoring period to indicate whether a pain flare occurred .
RESULTS	Pain flares were described most often by quality ( often sharp ) , followed by timing ( seconds , minutes ) and by antecedents and consequences .
RESULTS	When asked if their definition of a flare agreed with a supplied definition , 49 % of the sample reported only `` somewhat , '' `` a little , '' or `` not at all . ''
RESULTS	Using individual definitions , 78 % experienced at least 1 daily pain flare over the home monitoring period ; 24 % had a flare on more than 50 % of the monitored days .
CONCLUSIONS	Pain flares were common , fleeting , and often experienced in the context of activity engagement .
CONCLUSIONS	Participants ' views on what constitutes a pain flare differ from commonly accepted definitions .
CONCLUSIONS	Pain flares are an understudied aspect of the knee OA pain experience and require further characterization .

###24245914
BACKGROUND	Gestational diabetes mellitus ( GDM ) is increasing worldwide and has been associated with adverse perinatal outcomes and high risk for chronic disease both for the mother and for the child .
BACKGROUND	Physical exercise is feasible for diabetic pregnant women and contributes to better glycemic control and to a decrease in adverse perinatal outcomes .
BACKGROUND	However , there are no randomized controlled trials ( RCT ) assessing the effects of aquatic physical exercise on GDM control and adverse maternal and fetal outcomes .
METHODS	An RCT will be conducted at Instituto de Medicina Integral Prof Fernando Figueira ( IMIP ) , Brazil .
METHODS	A total of 72 pregnant women will be studied ; 36 gestational diabetics will undergo an aquatic physical exercise program in a thermal pool , 3 times per week over 2 months .
METHODS	The primary endpoint will be glucose level control and use of insulin ; secondary endpoints will be the following maternal and fetal outcomes : weight gain during pregnancy , blood pressure , pre-eclampsia diagnosis , intrauterus growth restriction , preterm birth , Cesarean section , macrosomia and maternal or neonatal intensive care admission .
METHODS	Endpoints between intervention and control group will analyzed by t test for unpaired data and test , and the level of significance will set at < 0.05 .
CONCLUSIONS	The physical proprieties of water make aquatic exercises ideal for pregnant women .
CONCLUSIONS	An aquatic physical exercise program developed for GDM women will be trialed in a thermal pool and under the supervision of physiotherapist to ensure compliance .
CONCLUSIONS	It is expected that this study will provide evidence as to the effect of aquatic physical exercise on GDM control .
BACKGROUND	ClinicalTrial.gov , NCT01940003 .

###24396959
OBJECTIVE	To compare the long-term efficacy of a corneal limbal conjunctival autograft combined with pterygium excision in the treatment of primary pterygium .
METHODS	This random control study included 63 patients ( 63 eyes ) with primary pterygium .
METHODS	These were randomly divided into a group with corneal limbal conjunctival autograft combined with pterygium excision ( group A ) and a group with pterygium excision with exposed sclera ( group B ) and subjected to long-term follow up .
METHODS	The surgical outcomes were classified and evaluated ( grade I-IV ) .
METHODS	Several indexes were analyzed , including ocular surface irritation symptom , tear film stability , surgical complication , and recurrence rate .
RESULTS	The follow up ranged from 24 to 38 months , ( 26.9 + / -3.4 ) months on average .
RESULTS	No recurrence was noted at 6 weeks postoperatively .
RESULTS	At 6 months postoperatively , the recurrence rate of pterygium was 5.2 % in group A and 8.0 % in group B.
RESULTS	At 1 year postoperatively , the recurrence rate in group A was 10.5 % and 20.0 % in group B.
RESULTS	At the end of follow up , the recurrence rates were 13.1 % in group A and 24.0 % in group B. No statistical significance was found between two groups regarding the recurrence rates at each time point ( P > 0.05 ) .
RESULTS	After the follow up ( > 2 years ) , the severity of ocular surface conditions was significantly milder in patients in group A than in group B ( P < 0.01 ) .
RESULTS	No statistically significant differences were noted between the two groups at 6 weeks , 6 months , and 1 year after surgery .
RESULTS	No statistically significant differences were observed between the two groups regarding postoperative tear film break-up time .
RESULTS	Fewer postoperative complications and milder ocular surface irritation symptoms occurred in patients in group A.
CONCLUSIONS	Corneal limbal conjunctival autograft combined with pterygium excision yields sound long-term efficacy and a low recurrence rate and induces only mild damage on the ocular surface when used as a treatment for pterygium .

###25128185
BACKGROUND	Young adulthood ( age 18 to 35 ) is a high-risk period for unhealthy weight gain .
BACKGROUND	Few studies have recruited for prevention of weight gain , particularly in young adults .
BACKGROUND	This paper describes the recruitment protocol used in the Study of Novel Approaches to Prevention ( SNAP ) .
METHODS	We conducted extensive formative work to inform recruitment methods and message development .
METHODS	We worked with a professional marketing firm to synthesize major themes and subsequently develop age-appropriate messages for recruitment .
METHODS	A variety of approaches and channels were used across two clinical centers to recruit young adults who were normal or overweight ( body mass index ( BMI ) 21 to 30kg/m2 ) for a 3-year intervention designed to prevent weight gain .
METHODS	We tracked recruitment methods , yields , and costs by method .
METHODS	Logistic regression was used to identify recruitment methods that had the highest relative yield for subgroups of interest with covariate adjustments for clinic .
RESULTS	The final sample of 599 participants ( 27 % minority , 22 % male ) was recruited over a 19-month period of sustained efforts .
RESULTS	About 10 % of those who initially expressed interest via a screening website were randomized .
RESULTS	The most common reason for ineligibility was already being obese ( BMI > 30kg/m2 ) .
RESULTS	The top two methods for recruitment were mass mailing followed by email ; together they were cited by 62 % of those recruited .
RESULTS	Television , radio , paid print advertising , flyers and community events each yielded fewer than 10 % of study participants .
RESULTS	Email was the most cost-effective method per study participant recruited .
CONCLUSIONS	These findings can guide future efforts to recruit young adults and for trials targeting weight gain prevention .
BACKGROUND	ClinicalTrials.gov NCT01183689 ( registered 13 August 2010 ) .

###25636714
OBJECTIVE	To evaluate immune responses in fingolimod-treated patients with multiple sclerosis ( MS ) against influenza vaccine ( to test for responses against anticipated novel antigens in seronegative patients ) and recall ( tetanus toxoid [ TT ] booster dose ) antigens .
METHODS	This was a blinded , randomized , multicenter , placebo-controlled study .
METHODS	Patients aged 18 to 55 years with relapsing MS were randomized ( 2:1 ) to fingolimod 0.5 mg or placebo for 12 weeks .
METHODS	At week 6 , patients received seasonal influenza vaccine ( containing antigens of California , Perth , and Brisbane virus strains ) and TT booster dose .
METHODS	Antibody titers against influenza and TT were estimated at baseline ( prevaccination ) and 3 and 6 weeks postvaccination .
METHODS	The primary efficacy variable was responder rate ( proportion of patients showing seroconversion or significant increase [ 4-fold ] in antibody titers against at least one influenza virus strain ) at 3 weeks postvaccination and vs placebo .
RESULTS	Of 138 randomized patients ( fingolimod 95 , placebo 43 ) , 136 completed the study ( 2 discontinued in fingolimod group ) .
RESULTS	The responder rates ( odds ratio ; 95 % confidence interval ) for influenza vaccine ( fingolimod vs placebo ) were 54 % vs 85 % ( 0.21 ; 0.08-0 .54 ) at 3 weeks and 43 % vs 75 % ( 0.25 ; 0.11-0 .57 ) at 6 weeks postvaccination .
RESULTS	For TT , responder rates were 40 % vs 61 % ( 0.43 ; 0.20-0 .92 ) at 3 weeks and 38 % vs 49 % ( 0.62 ; 0.29-1 .33 ) at 6 weeks postvaccination .
RESULTS	Adverse events were reported in 86.3 % and 79.1 % of patients receiving fingolimod and placebo , respectively .
CONCLUSIONS	Most fingolimod-treated patients with MS were able to mount immune responses against novel and recall antigens and the majority met regulatory criteria indicating seroprotection .
CONCLUSIONS	However , response rates were reduced compared with placebo-treated patients .
CONCLUSIONS	This should be kept in mind when vaccinating patients on fingolimod .
METHODS	This study provides Class I evidence that in some patients with MS receiving immunizations , concurrent fingolimod treatment in comparison to placebo decreases vaccination-induced immune responses .

###24801511
OBJECTIVE	New femtosecond laser platforms may reduce ocular surface interference and LASIK-associated dry eye .
OBJECTIVE	This study investigated tear protein profiles in subjects who underwent LASIK using two femtosecond lasers to assess differences in protein expression .
METHODS	This was a randomized interventional clinical trial involving 22 patients who underwent femtosecond laser refractive surgery with a contralateral paired eye design .
METHODS	Corneal flaps of 22 subjects were created by either Visumax or Intralase laser .
METHODS	Tear samples were collected preoperatively , and at 1 week and 3 months postoperatively using Schirmer 's strips .
METHODS	Tear protein ratios were calculated relative to preoperative protein levels at baseline .
METHODS	The main outcome measures were the levels of a panel of dry eye protein markers analyzed using isobaric tagging for relative and absolute quantitation ( iTRAQ ) mass spectrometry .
RESULTS	A total of 824 unique proteins were quantifiable .
RESULTS	Tear protein ratios were differentially regulated between the eyes treated with different lasers .
RESULTS	The secretoglobulins Lipophilin A ( 1.80-fold ) and Lipophilin C ( 1.77 ) were significantly upregulated ( P < 0.05 ) at 1 week postoperatively in Visumax but not in Intralase-treated eyes .
RESULTS	At 1 week , orosomucoid1 was upregulated ( 1.78 ) in Intralase but not Visumax-treated eyes .
RESULTS	In the same eyes , lysozyme , cathepsin B , and lipo-oxygenase were downregulated at 0.44 - , 0.64 - , and 0.64-folds , respectively .
RESULTS	Transglutaminase-2 was downregulated in both groups of eyes .
CONCLUSIONS	Different laser platforms induce distinct biological responses in the cornea and ocular surface , which manifests as different levels of tear proteins .
CONCLUSIONS	This study has implications for surgical technology and modulation of wound healing responses .
CONCLUSIONS	( ClinicalTrials.gov number , NCT01252654 . )

###25180876
OBJECTIVE	To determine if atomoxetine would improve attention impairment following traumatic brain injury ( TBI ) .
METHODS	Outpatients from a free-standing , private , not-for-profit rehabilitation hospital .
METHODS	Fifty-five adult participants with a history of a single moderate-to-severe TBI , who were at least 1 year from injury and with self-reported complaints of attention difficulties .
METHODS	Atomoxetine , a selective norepinephrine re-uptake inhibitor with a primary indication for attention dosed at 40mg twice a day for 2 weeks , compared to placebo .
METHODS	Randomized double-blind placebo controlled trial , with placebo run-in .
METHODS	Cognitive Drug Research ( CDR ) , Computerized Cognitive Assessment System , Stroop Color and Word Test , Adult ADHD Self-Report Scale ( ASRS-v1 .1 ) , Neurobehavioural Functioning Inventory ( NFI ) .
RESULTS	Atomoxetine was well-tolerated by the subject sample .
RESULTS	The use of atomoxetine by individuals with reported attention difficulty following TBI did not significantly improve scores on measures of attention , the CDR Power of Attention domain or the Stroop Interference score .
RESULTS	In addition , no significant relationship was found between atomoxetine use and self-reported symptoms of attention or depression .
CONCLUSIONS	Atomoxetine did not significantly improve performance on measures of attention among individuals post-TBI with difficulties with attention .
CONCLUSIONS	This study follows a trend of other pharmacological studies not demonstrating significant results among those with a history of TBI .
CONCLUSIONS	Various possibilities are discussed , including the need for a more sophisticated system of classification of TBI .

###24810369
OBJECTIVE	To assess the efficacy and safety of enzyme replacement therapy ( ERT ) with BMN 110 ( elosulfase alfa ) in patients with Morquio A syndrome ( mucopolysaccharidosis IVA ) .
METHODS	Patients with Morquio A aged 5years ( N = 176 ) were randomised ( 1:1:1 ) to receive elosulfase alfa 2.0 mg/kg/every other week ( qow ) , elosulfase alfa 2.0 mg/kg/week ( weekly ) or placebo for 24weeks in this phase 3 , double-blind , randomised study .
METHODS	The primary efficacy measure was 6-min walk test ( 6MWT ) distance .
METHODS	Secondary efficacy measures were 3-min stair climb test ( 3MSCT ) followed by change in urine keratan sulfate ( KS ) .
METHODS	Various exploratory measures included respiratory function tests .
METHODS	Patient safety was also evaluated .
RESULTS	At week 24 , the estimated mean effect on the 6MWT versus placebo was 22.5 m ( 95 % CI 4.0 , 40.9 ; P = 0.017 ) for weekly and 0.5 m ( 95 % CI -17.8 , 18.9 ; P = 0.954 ) for qow .
RESULTS	The estimated mean effect on 3MSCT was 1.1 stairs/min ( 95 % CI -2.1 , 4.4 ; P = 0.494 ) for weekly and -0.5 stairs/min ( 95 % CI -3.7 , 2.8 ; P = 0.778 ) for qow .
RESULTS	Normalised urine KS was reduced at 24weeks in both regimens .
RESULTS	In the weekly dose group , 22.4 % of patients had adverse events leading to an infusion interruption/discontinuation requiring medical intervention ( only 1.3 % of all infusions in this group ) over 6months .
RESULTS	No adverse events led to permanent treatment discontinuation .
CONCLUSIONS	Elosulfase alfa improved endurance as measured by the 6MWT in the weekly but not qow dose group , did not improve endurance on the 3MSCT , reduced urine KS , and had an acceptable safety profile .

###26178888
BACKGROUND	The availability of less resource-intensive alternatives to home visits for rehabilitation following orthopaedic surgeries is important , given the increasing need for home care services and the shortage of health resources .
BACKGROUND	The goal of this trial was to determine whether an in-home telerehabilitation program is not clinically inferior to a face-to-face home visit approach ( standard care ) after hospital discharge of patients following a total knee arthroplasty .
METHODS	Two hundred and five patients who had a total knee arthroplasty were randomized before hospital discharge to the telerehabilitation group or the face-to-face home visit group .
METHODS	Both groups received the same rehabilitation intervention for two months after hospital discharge .
METHODS	Patients were evaluated at baseline ( before total knee arthroplasty ) , immediately after the rehabilitation intervention ( two months after discharge ) , and two months later ( four months after discharge ) .
METHODS	The primary outcome measure was the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) questionnaire at the last follow-up evaluation .
METHODS	Secondary outcome measures included the Knee Injury and Osteoarthritis Outcome Score ( KOOS ) questionnaire , functional and strength tests , and knee range of motion .
METHODS	The noninferiority margin was set at 9 % for the WOMAC .
RESULTS	The demographic and clinical characteristics of the two groups of patients were similar at baseline .
RESULTS	At the last follow-up evaluation , the mean differences between the groups with regard to the WOMAC gains , adjusted for baseline values , were near zero ( for 182 patients in the per-protocol analysis ) : -1.6 % ( 95 % confidence interval [ CI ] : -5.6 % , 2.3 % ) for the total score , -1.6 % ( 95 % CI : -5.9 % , 2.8 % ) for pain , -0.7 % ( 95 % CI : -6.8 % , 5.4 % ) for stiffness , and -1.8 % ( 95 % CI : -5.9 % , 2.3 % ) for function .
RESULTS	The confidence intervals were all within the predetermined zone of noninferiority .
RESULTS	The secondary outcomes had similar results , as did the intention-to-treat analysis , which was conducted afterward for 198 patients .
CONCLUSIONS	Our results demonstrated the noninferiority of in-home telerehabilitation and support its use as an effective alternative to face-to-face service delivery after hospital discharge of patients following a total knee arthroplasty .
METHODS	Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence .

###24943065
BACKGROUND	Closed-loop insulin delivery is a promising option to improve glycaemic control and reduce the risk of hypoglycaemia .
BACKGROUND	We aimed to assess whether overnight home use of automated closed-loop insulin delivery would improve glucose control .
METHODS	We did this open-label , multicentre , randomised controlled , crossover study between Dec 1 , 2012 , and Dec 23 , 2014 , recruiting patients from three centres in the UK .
METHODS	Patients aged 18 years or older with type 1 diabetes were randomly assigned to receive 4 weeks of overnight closed-loop insulin delivery ( using a model-predictive control algorithm to direct insulin delivery ) , then 4 weeks of insulin pump therapy ( in which participants used real-time display of continuous glucose monitoring independent of their pumps as control ) , or vice versa .
METHODS	Allocation to initial treatment group was by computer-generated permuted block randomisation .
METHODS	Each treatment period was separated by a 3-4 week washout period .
METHODS	The primary outcome was time spent in the target glucose range of 39-80 mmol/L between 0000 h and 0700 h. Analyses were by intention to treat .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01440140 .
RESULTS	We randomly assigned 25 participants to initial treatment in either the closed-loop group or the control group , patients were later crossed over into the other group ; one patient from the closed-loop group withdrew consent after randomisation , and data for 24 patients were analysed .
RESULTS	Closed loop was used over a median of 83 h ( IQR 60-96 ) on 555 ( 86 % ) of 644 nights .
RESULTS	The proportion of time when overnight glucose was in target range was significantly higher during the closed-loop period compared to during the control period ( mean difference between groups 135 % , 95 % CI 73-197 ; p = 00002 ) .
RESULTS	We noted no severe hypoglycaemic episodes during the control period compared with two episodes during the closed-loop period ; these episodes were not related to closed-loop algorithm instructions .
CONCLUSIONS	Unsupervised overnight closed-loop insulin delivery at home is feasible and could improve glucose control in adults with type 1 diabetes .
BACKGROUND	Diabetes UK .

###24703531
BACKGROUND	Advanced colorectal cancer is treated with a combination of cytotoxic drugs and targeted treatments .
BACKGROUND	However , how best to minimise the time spent taking cytotoxic drugs and whether molecular selection can refine this further is unknown .
BACKGROUND	The primary aim of this study was to establish how cetuximab might be safely and effectively added to intermittent chemotherapy .
METHODS	COIN-B was an open-label , multicentre , randomised , exploratory phase 2 trial done at 30 hospitals in the UK and one in Cyprus .
METHODS	We enrolled patients with advanced colorectal cancer who had received no previous chemotherapy for metastases .
METHODS	Randomisation was done centrally ( by telephone ) by the Medical Research Council Clinical Trials Unit using minimisation with a random element .
METHODS	Treatment allocation was not masked .
METHODS	Patients were assigned ( 1:1 ) to intermittent chemotherapy plus intermittent cetuximab or to intermittent chemotherapy plus continuous cetuximab .
METHODS	Chemotherapy was FOLFOX ( folinic acid and oxaliplatin followed by bolus and infused fluorouracil ) .
METHODS	Patients in both groups received FOLFOX and weekly cetuximab for 12 weeks , then either had a planned interruption ( those taking intermittent cetuximab ) or planned maintenance by continuing on weekly cetuximab ( continuous cetuximab ) .
METHODS	On RECIST progression , FOLFOX plus cetuximab or FOLFOX was recommenced for 12 weeks followed by further interruption or maintenance cetuximab , respectively .
METHODS	The primary outcome was failure-free survival at 10 months .
METHODS	The primary analysis population consisted of patients who completed 12 weeks of treatment without progression , death , or leaving the trial .
METHODS	We tested BRAF and NRAS status retrospectively .
METHODS	The trial was registered , ISRCTN38375681 .
RESULTS	We registered 401 patients , 226 of whom were enrolled .
RESULTS	Results for 169 with KRAS wild-type are reported here , 78 ( 46 % ) assigned to intermittent cetuximab and 91 ( 54 % ) to continuous cetuximab .
RESULTS	64 patients assigned to intermittent cetuximab and 66 of those assigned to continuous cetuximab were included in the primary analysis .
RESULTS	10-month failure-free survival was 50 % ( lower bound of 95 % CI 39 ) in the intermittent group versus 52 % ( lower bound of 95 % CI 41 ) in the continuous group ; median failure-free survival was 12.2 months ( 95 % CI 8.8-15 .6 ) and 14.3 months ( 10.7-20 .4 ) , respectively .
RESULTS	The most common grade 3-4 adverse events were skin rash ( 21 [ 27 % ] of 77 patients vs 20 [ 22 % ] of 92 patients ) , neutropenia ( 22 [ 29 % ] vs 30 [ 33 % ] ) , diarrhoea ( 14 [ 18 % ] vs 23 [ 25 % ] ) , and lethargy ( 20 [ 26 % ] vs 19 [ 21 % ] ) .
CONCLUSIONS	Cetuximab was safely incorporated in two first-line intermittent chemotherapy strategies .
CONCLUSIONS	Maintenance of biological monotherapy , with less cytotoxic chemotherapy within the first 6 months , in molecularly selected patients is promising and should be validated in phase 3 trials .

###25487196
BACKGROUND	Myocardial infarction is the leading cause of death in fire fighters and has been linked with exposure to air pollution and fire suppression duties .
BACKGROUND	We therefore investigated the effects of wood smoke exposure on vascular vasomotor and fibrinolytic function , and thrombus formation in healthy fire fighters .
METHODS	In a double-blind randomized cross-over study , 16 healthy male fire fighters were exposed to wood smoke ( ~ 1 mg/m particulate matter concentration ) or filtered air for one hour during intermittent exercise .
METHODS	Arterial pressure and stiffness were measured before and immediately after exposure , and forearm blood flow was measured during intra-brachial infusion of endothelium-dependent and - independent vasodilators 4-6 hours after exposure .
METHODS	Thrombus formation was assessed using the ex vivo Badimon chamber at 2 hours , and platelet activation was measured using flow cytometry for up to 24 hours after the exposure .
RESULTS	Compared to filtered air , exposure to wood smoke increased blood carboxyhaemoglobin concentrations ( 1.3 % versus 0.8 % ; P < 0.001 ) , but had no effect on arterial pressure , augmentation index or pulse wave velocity ( P > 0.05 for all ) .
RESULTS	Whilst there was a dose-dependent increase in forearm blood flow with each vasodilator ( P < 0.01 for all ) , there were no differences in blood flow responses to acetylcholine , sodium nitroprusside or verapamil between exposures ( P > 0.05 for all ) .
RESULTS	Following exposure to wood smoke , vasodilatation to bradykinin increased ( P = 0.003 ) , but there was no effect on bradykinin-induced tissue-plasminogen activator release , thrombus area or markers of platelet activation ( P > 0.05 for all ) .
CONCLUSIONS	Wood smoke exposure does not impair vascular vasomotor or fibrinolytic function , or increase thrombus formation in fire fighters .
CONCLUSIONS	Acute cardiovascular events following fire suppression may be precipitated by exposure to other air pollutants or through other mechanisms , such as strenuous physical exertion and dehydration .

###24664189
OBJECTIVE	The New Nordic Diet ( NND ) has induced weight loss in a 26-week controlled intervention .
OBJECTIVE	We aim to investigate whether high compliance and satisfaction can be maintained after the active intervention is discontinued thereby maintaining the health effects .
METHODS	After 26 weeks of intervention with NND or Average Danish Diet ( ADD ) , 147 participants ( mean age 43 years and mean BMI 29.1 kg/m ) were followed for further 52 weeks .
METHODS	All participants were encouraged to follow NND but without further guidance .
METHODS	The study is registered with ClinicalTrials.gov , study id NCT01195610 .
RESULTS	One hundred and ten participants ( 75 % ) completed the follow-up .
RESULTS	Among participants previously randomised to NND ( NND group ) , dietary compliance and satisfaction decreased from 4.3 to 3.0 and from 4.8 to 4.0 , respectively ( both p < 0.0001 ) ( 1-5 point scale ) .
RESULTS	Among those originally randomised to ADD ( ADD group ) , satisfaction with NND was significantly higher than with ADD during follow-up ( 3.3 vs. 2.5 , p = 0.026 ) .
RESULTS	Weight losses during intervention of -6.2 kg and -3.0 kg were followed by regains of 4.6 kg ( SE 0.5 ) and 1.1 kg ( SE 0.7 ) for the NND group and ADD group , respectively [ adjusted difference ; mean ( 95 % CI ) : 1.8 kg ( 0.1-3 .4 ) , p = 0.041 ] .
RESULTS	Across diet groups , every 1 score higher in compliance with NND was associated with 0.90 kg less body weight regain ( p = 0.026 ) and those who increased physical activity regained 3.4 kg less compared to those who did not ( p < 0.0001 ) .
CONCLUSIONS	NND provides higher satisfaction , and body weight regain is reduced with higher compliance with NND and increased physical activity .

###24641937
BACKGROUND	Advanced pancreatic cancer ( APC ) , beside its high mortality , causes the highest rates of venous thromboembolic events ( VTE ) .
BACKGROUND	Enoxaparin , a low molecular weight heparin ( LMWH ) , is effective in prevention and treatment of VTE .
BACKGROUND	Some small studies indicated that this benefit might extend to patients with cancer and probably prolong survival due to independent mechanisms .
BACKGROUND	We initiated this safety investigation to get feasibility information on intensified chemotherapy combined with LMWH in outpatients with APC treated in 1st line .
METHODS	The trial was a prospective , open-label , single center investigation in outpatients with inoperable pancreatic cancer who were treated with intensified first-line chemotherapy along with concomitant application of subcutaneous LMWH .
METHODS	The combined chemotherapy consisted of gemcitabine 1 g/m2 ( 30 min ) , 5-FU 750 mg/m2 ( 24 h ) , folinic acid 200 mg/m2 ( 30 min ) , and Cisplatin 30 mg/m2 ( 90 min ) on day 1 and 8 ; q3w for the first 12 weeks ( GFFC ) followed by gemcitabine alone in patients without cancer progression .
METHODS	The simultaneous application of prophylactic enoxaparin started on day 1 of chemotherapy with a fixed dose of 40 mg daily .
METHODS	Statistical analyses were performed using R 3.01 with software package CMPRSK and SPSS software v19 .0 .
RESULTS	The investigation was stopped after recruitment of 19 patients .
RESULTS	At this time 15 patients had completed the required 12 weeks of treatment .
RESULTS	Based on 71 cycles of GFFC + enoxaparin ( median 4/pt [ range : 2-4 ] ) and 108 cycles of single-agent gemcitabine + enoxaparin ( median 4/pt [ range : 0-18 ] ) the cumulative frequency of NCI-CTC toxicities grade 3/4 was below 10 % .
RESULTS	One case ( 5 % ) of a symptomatic non-lethal thromboembolic event was observed while receiving LMWH treatment .
RESULTS	No severe bleeding event as defined in the protocol has been observed .
RESULTS	The median overall survival was 10.05 [ 95 % CI : 8.67-18 .14 ] months .
CONCLUSIONS	The addition of enoxaparin to GFFC chemotherapy is feasible , safe and does not appear to affect the efficacy or the toxicity profile of the chemotherapy regimen in patients with advanced pancreatic adenocarcinoma .
CONCLUSIONS	Based on these findings we have initiated the randomized CONKO-004 trial to examine whether enoxaparin reduces the incidence of thromboembolic events or increases overall outcome .
BACKGROUND	Clinical Trials NCT01945879 .

###25681464
BACKGROUND	Vorapaxar reduces cardiovascular death , myocardial infarction ( MI ) , or stroke in patients with previous MI while increasing bleeding .
BACKGROUND	Patients with diabetes mellitus ( DM ) are at high risk of recurrent thrombotic events despite standard therapy and may derive particular benefit from antithrombotic therapies .
BACKGROUND	The Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events-TIMI 50 trial was a randomized , double-blind , placebo-controlled trial of vorapaxar in patients with stable atherosclerosis .
RESULTS	We examined the efficacy of vorapaxar in patients with and without DM who qualified for the trial with a previous MI .
RESULTS	Because vorapaxar is contraindicated in patients with a history of stroke or transient ischemic attack , the analysis ( n = 16 896 ) excluded such patients .
RESULTS	The primary end point of cardiovascular death , MI , or stroke occurred more frequently in patients with DM than in patients without DM ( rates in placebo group : 14.3 % versus 7.6 % ; adjusted hazard ratio , 1.47 ; P < 0.001 ) .
RESULTS	In patients with DM ( n = 3623 ) , vorapaxar significantly reduced the primary end point ( 11.4 % versus 14.3 % ; hazard ratio , 0.73 [ 95 % confidence interval , 0.60-0 .89 ] ; P = 0.002 ) with a number needed to treat to avoid 1 major cardiovascular event of 29 .
RESULTS	The incidence of moderate/severe bleeding was increased with vorapaxar in patients with DM ( 4.4 % versus 2.6 % ; hazard ratio , 1.60 [ 95 % confidence interval , 1.07-2 .40 ] ) .
RESULTS	However , net clinical outcome integrating these 2 end points ( efficacy and safety ) was improved with vorapaxar ( hazard ratio , 0.79 [ 95 % confidence interval , 0.67-0 .93 ] ) .
CONCLUSIONS	In patients with previous MI and DM , the addition of vorapaxar to standard therapy significantly reduced the risk of major vascular events with greater potential for absolute benefit in this group at high risk of recurrent ischemic events .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00526474 .

###25689448
OBJECTIVE	To assess the efficacy and safety of eslicarbazepine acetate ( ESL ) as monotherapy in North American patients with partial-onset seizures ( POS ) .
METHODS	This multicenter , randomized , double-blind `` withdrawal to monotherapy '' study used historical control data as the comparator .
METHODS	Adults with POS medically uncontrolled by one to two antiepileptic drugs gradually converted to ESL monotherapy .
METHODS	Following an 8-week baseline period , patients were randomized 2:1 to receive ESL 1,600 mg ( n = 128 ) or 1,200 mg QD ( n = 65 ) for 18 weeks .
METHODS	The primary end point was the proportion of patients meeting predefined exit criteria ( signifying worsening seizure control ) .
METHODS	Treatment was considered effective if the 95 % upper confidence limit ( UCL ) for the Kaplan-Meier estimated exit rate was lower than the exit rate threshold calculated from the historical control ( 65.3 % ) .
RESULTS	Kaplan-Meier estimated exit rates were : ESL 1,600 mg , 28.7 % ( 95 % CI 21.2-38 .1 % ) and 1,200 mg , 44.4 % ( 32.5-58 .3 % ) .
RESULTS	The difference between doses was not significant ( p = 0.07 ) .
RESULTS	For both doses , the 95 % UCLs for the exit rate were 65.3 % ; ESL monotherapy was considered superior to the historical control .
RESULTS	There was no statistically significant increase in the risk of study exit related to carbamazepine use .
RESULTS	Nine ( 7.6 % ) and five patients ( 8.3 % ) remained seizure-free during the 10-week monotherapy period , while taking ESL 1,600 and 1,200 mg , respectively .
RESULTS	The reductions in median standardized seizure frequency ( seizures per 28 days ) between baseline and the 18-week treatment period were : ESL 1,600 mg , 42 % and 1,200 mg , 31 % .
RESULTS	Treatment-emergent adverse events ( TEAEs ) occurring in 10 % of patients were dizziness , headache , fatigue , somnolence , nausea , and nasopharyngitis .
RESULTS	The TEAE most frequently leading to discontinuation was hyponatremia ( 2.1 % ) .
CONCLUSIONS	ESL was efficacious and well tolerated as monotherapy in North American patients , and led to a reduction in seizure frequency .
CONCLUSIONS	Exit rates for ESL 1,600 and 1,200 mg QD were superior to the historical control ; the difference in exit rates between doses was not statistically significant .

###25567115
OBJECTIVE	Interleukin 13 ( IL-13 ) is thought to play a key role as an effector cytokine in UC .
OBJECTIVE	Anrukinzumab , a humanised antibody that inhibits human IL-13 , was evaluated for the treatment of UC .
METHODS	In a multicentre , randomised , double-blind , placebo-controlled study , patients with active UC ( Mayo score 4 and < 10 ) were randomised to anrukinzumab 200 , 400 or 600mg or placebo .
METHODS	Patients received five intravenous administrations over 14weeks .
METHODS	The primary endpoint was fold change from baseline in faecal calprotectin ( FC ) at Week 14 .
METHODS	Secondary endpoints included safety , pharmacokinetics and IL-13 levels .
RESULTS	The modified intention-to-treat population included 84 patients ( 21 patients/arm ) .
RESULTS	Fold change of FC from baseline at Week 14 was not significantly different for any treatment groups compared with the placebo .
RESULTS	The study had a high dropout rate , in part , related to lack of efficacy .
RESULTS	The exploratory comparisons of each dose were not significantly different from placebo in terms of change from baseline in total Mayo score , clinical response , clinical remission and proportion of subjects with mucosal healing .
RESULTS	An increase in serum total IL-13 ( free and bound to anrukinzumab ) was observed for all anrukinzumab groups but not with placebo .
RESULTS	This suggests significant binding of anrukinzumab to IL-13 .
RESULTS	The safety profile was not different between the anrukinzumab and placebo groups .
CONCLUSIONS	A statistically significant therapeutic effect of anrukinzumab could not be demonstrated in patients with active UC in spite of binding of anrukinzumab to IL-13 .
BACKGROUND	ClinicalTrials.gov number NCT01284062 .

###24786196
OBJECTIVE	To investigate the changes in adrenocorticotropic hormone ( ACTH ) and cortisol in heroin addicts given Jitai tablet treatment during abstinence .
METHODS	Double-blind , randomized , placebo-controlled clinical trial .
METHODS	Drug Rehabilitation Bureau of Shanghai Police , China .
METHODS	99 volunteers , including 69 heroin addicts and 30 healthy volunteers .
METHODS	69 heroin addicts randomly divided into two groups : the Jitai tablet group , which comprised 34 heroin addicts given Jitai tablet treatment during abstinence , and the placebo group , which comprised 35 heroin addicts given placebo .
METHODS	A control group consisted of 30 sex - and age-matched healthy volunteers .
METHODS	ACTH and cortisol in plasma were measured in all groups at baseline and in the Jitai tablet and placebo groups on the third , seventh , and 14th days of abstinence .
RESULTS	Levels of both ACTH ( p < .01 ) and cortisol ( p < .001 ) were significantly higher in heroin addicts at baseline than in the healthy volunteers .
RESULTS	Jitai tablet treatment restored plasma cortisol levels to normal more rapidly than did placebo treatment ( p < .05 ) , but not ACTH levels .
RESULTS	A positive correlation between ACTH and cortisol values at baseline ( p < .01 ) was also found with withdrawal symptom scores and daily dosages of heroin .
CONCLUSIONS	Heroin addicts could respond to Jitai tablets through changes in the hypothalamus-pituitary-adrenal axis .

###24617776
OBJECTIVE	Former cancer patients ' quality of life can be improved by offering social comparison information .
OBJECTIVE	Whether patients , however , benefit from the information may depend on how negative they perceive their present and their future .
METHODS	We conducted a randomised experimental field study with a pre - and post-measurement .
METHODS	Dutch former cancer patients - recruited through different media - were assigned to a social comparison intervention condition or a no-intervention control condition ( experimental condition n = 62 ; control condition n = 88 ; Mage = 52 years ) .
METHODS	In the intervention condition , patients received a 20 min computer-tailored interview in audio format .
METHODS	Patients ' present perceived life threat and future health expectations were measured at pretest .
METHODS	Quality of life and life satisfaction after 2 months were the outcome variables .
RESULTS	The intervention increased life satisfaction only in patients who experienced a high present life threat ( [ Formula : see text ] = .08 ) and in patients who had negative future health expectations , the intervention increased quality of life ( [ Formula : see text ] = .05 ) .
CONCLUSIONS	Not all patients did benefit from the intervention ; for some patients , the social comparison intervention was even detrimental .
CONCLUSIONS	Moderator analyses seem necessary to evaluate psycho-social interventions for cancer patients .

###25277158
BACKGROUND	At least 13 % of mothers experience depression in the first postnatal year , with accompanying feelings of despair and a range of debilitating symptoms .
BACKGROUND	Serious sequelae include disturbances in the mother-infant relationship and poor long-term cognitive and behavioural outcomes for the child .
BACKGROUND	Surprisingly , treatment of maternal symptoms of postnatal depression does not improve the mother-infant relationship for a majority of women .
BACKGROUND	Targeted interventions to improve the mother-infant relationship following postnatal depression are scarce and , of those that exist , the majority are not evaluated in randomised controlled trials .
BACKGROUND	This study aims to evaluate a brief targeted mother-infant intervention , to follow cognitive behavioural therapy treatment of postnatal depression , which has the potential to improve developmental outcomes of children of depressed mothers .
METHODS	The proposed study is a two-arm randomised controlled trial with follow-up to 6 months .
METHODS	One hundred participants will be recruited via referrals from health professionals including maternal and child health nurses and general practitioners , as well as self-referrals from women who have seen promotional materials for the study .
METHODS	Women who meet inclusion criteria ( infant aged < 12 months , women 18 + years of age ) will complete the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders-IV-TR Axis I Disorders .
METHODS	Those with a clinical diagnosis of current major or minor depressive disorder and who do not meet exclusion criteria ( that is , currently receiving treatment for depression , significant difficulty with English , medium to high suicide risk , current self-harm , current substance abuse , current post-traumatic stress disorder , current manic/hypomanic episode or psychotic symptoms ) will be randomised to receive either a 4-session mother-infant intervention ( HUGS : Happiness Understanding Giving and Sharing ) or a 4-session attention placebo playgroup ( Playtime ) following a 12-session postnatal depression group treatment programme .
METHODS	Primary outcome measures are the Parenting Stress Index ( self-report measure ) and the Parent-child Early Relational Assessment ( observational measure coded by a blinded observer ) .
METHODS	Measurements are taken at baseline , after the postnatal depression programme , post-HUGS/Playtime , and at 6 months post-HUGS/Playtime .
CONCLUSIONS	This research addresses the need for specific treatment for mother-infant interactional difficulties following postnatal depression .
CONCLUSIONS	There is a need to investigate interventions in randomised trials to prevent detrimental effects on child development and make available evidence-based treatments .
BACKGROUND	Australia and New Zealand Clinical Trials Register : ACTRN12612001110875 .
BACKGROUND	Date Registered : 17 October 2012 .

###25497250
BACKGROUND	Only limited data from large randomized clinical trials have been published on the long-term performance of second-generation drug-eluting stents in bifurcation lesions .
METHODS	We investigated in patients in the randomized TWENTE trial the long-term safety and efficacy of treating bifurcation lesions with 2 widely applied second-generation drug-eluting stents , the zotarolimus-eluting Resolute stent ( Medtronic Inc , Santa Rosa , CA ) and the everolimus-eluting Xience V stent ( Abbott Vascular , Santa Clara , CA ) .
METHODS	Three-year follow-up was available in 99.3 % .
METHODS	Patients were categorized into treatment for 1 bifurcation lesion versus treatment for nonbifurcation lesions only .
RESULTS	Among the 1,391 patients of the TWENTE trial , 362 ( 26 % ) were treated for bifurcation lesions .
RESULTS	At 3-year follow-up , target-vessel failure did not differ between patients treated for bifurcation versus nonbifurcation lesions ( 13.1 % vs 12.6 % ; P = .84 ) , whereas the periprocedural myocardial infarction rate was higher in patients with bifurcation lesions ( 6.9 % vs 3.1 % ; P < .01 ) .
RESULTS	Of the 362 patients with bifurcation lesion treatment , 179 ( 49.4 % ) were treated with Resolute and 183 ( 50.6 % ) with Xience V.
RESULTS	There was no significant difference in target-vessel failure between the Resolute and Xience V groups with bifurcation treatment ( 13.6 % vs 12.6 % ; P = .78 ) , and their incidence of definite-or-probable stent thrombosis was low and similar ( 1.1 % vs 0.5 % , respectively ; P = .62 ) .
CONCLUSIONS	Despite a significant difference in periprocedural myocardial infarction , 3-year clinical outcome after implantation of second-generation stents was favorable and similar for patients with and without bifurcation lesions .
CONCLUSIONS	In addition , we observed no difference in long-term clinical outcome after bifurcation lesion treatment with Resolute and Xience V stents .

###24258099
OBJECTIVE	The aim was to evaluate , using urethral pressure reflectometry ( UPR ) , the effect of fesoterodine on urethral function in women with stress urinary incontinence ( SUI ) .
METHODS	Women aged 18 to 65 years were eligible for this randomised , double-blind , placebo-controlled , crossover study if they had had clinically significant SUI or SUI-predominant mixed urinary incontinence for > 3 months .
METHODS	Each participant received fesoterodine 4 mg , fesoterodine 8 mg , and placebo once daily for 7 days , with a 7 - to 10-day washout between treatments .
METHODS	UPR was performed at baseline and 4 to 8 h after the last dose in each treatment period .
METHODS	Participants completed a 3-day bladder diary before randomisation and during the last 3 days of each treatment period .
RESULTS	Of the 22 women randomly assigned and treated , 17 met the criteria for the primary efficacy analyses .
RESULTS	No statistically significant differences were seen between fesoterodine 4 mg or fesoterodine 8 mg and placebo in opening urethral pressure ( primary endpoint ) or other UPR endpoints .
RESULTS	No statistically significant differences were seen between either fesoterodine dose and placebo in the change from baseline in the bladder diary variables ( total urinary incontinence , SUI , or urgency urinary incontinence episodes per 24 h ) .
RESULTS	Adverse events were reported by 8 participants taking fesoterodine 4 mg , 17 taking fesoterodine 8 mg , and 8 taking placebo .
CONCLUSIONS	Fesoterodine did not affect urethral pressure or significantly decrease the number of incontinence episodes in women with SUI .
CONCLUSIONS	The UPR parameters showed no placebo effect , while there was a placebo effect of 60 % based on the bladder diary .

###25166455
OBJECTIVE	Insufficient asthma management leads to impaired health-related quality of life ( HRQL ) .
OBJECTIVE	The aim of this study is to assess whether individualized self-management ( ISM ) support will improve HRQL in children with asthma compared to enhanced usual care ( EUC ) in Dutch general practices .
METHODS	A cluster-randomized controlled trial with 9-month follow-up .
METHODS	ISM is a nurse-led intervention that is optimized to the needs of children , leading to a written action plan .
METHODS	Power calculation demanded inclusion of 170 children ( aged 6-11years ) diagnosed with asthma and active medication use .
RESULTS	Outcomes were HRQL of the child ( Paediatric Asthma Quality of Life Questionnaire , PAQLQ-s ) and several secondary outcomes .
RESULTS	Data of 29 children ( mean age 8.6 years , SD 1.7 ) were analyzed ; ISM ( n = 15 ) or EUC ( n = 14 ) .
RESULTS	Logistic regression analysis ( minimal clinical important difference ; MCID0 .5 ) and descriptive analyses were performed .
RESULTS	Despite high PAQLQ-s score at baseline ( median ISM 6.35 , EUC 6.02 ) , a substantial number of subjects from both groups showed MCID of HRQL ( ISM 33 % , EUC 57 % ) .
RESULTS	Treatment differences on HRQL were not significant ( OR 0.38 , 95 % CI 0.08 , 1.69 ) .
RESULTS	Secondary outcomes did not show significant differences either , with exception of PAQLQ-s symptoms domain score in favor of EUC .
CONCLUSIONS	Due to recruitment problems and underpowered analyses , no firm conclusions on the effectiveness of ISM support for childhood asthma in primary care could be drawn .
CONCLUSIONS	Still , this study can be considered a valuable pilot study and in the future , there might be better capacity in general practices to commit to such treatment .

###24886116
BACKGROUND	Challenges remain to find ways to support patients with depression who have low levels of physical activity ( PA ) to overcome perceived barriers and enhance the perceived value of PA for preventing future relapse .
BACKGROUND	There is an evidence-base for behavioural activation ( BA ) for depression , which focuses on supporting patients to restore activities that have been avoided , but practitioners have no specific training in promoting PA. .
BACKGROUND	We aimed to design and evaluate an integrated BA and PA ( BAcPAc ) practitioner-led , written , self-help intervention to enhance both physical and mental health .
METHODS	This study is informed by the Medical Research Council Complex Intervention Framework and describes a protocol for a pilot phase II randomised controlled trial ( RCT ) to test the feasibility and acceptability of the trial methods to inform a definitive phase III RCT .
METHODS	Following development of the augmented written self-help intervention ( BAcPAc ) incorporating behavioural activation with physical activity promotion , depressed adults are randomised to receive up to 12 sessions over a maximum of 4months of either BAcPAc or behavioural activation alone within a written self-help format , which represents treatment as usual .
METHODS	The study is located within two ` Improving Access to Psychological Therapies ' services in South West England , with both written self-help interventions supported by mental health paraprofessionals .
METHODS	Measures assessed at 4 , 9 , and 12month follow-up include the following : CIS-R , PHQ-9 , accelerometer recorded ( 4months only ) and self-reported PA , body mass index , blood pressure , Insomnia Severity Index , quality of life , and health and social care service use .
METHODS	Process evaluation will include analysis of recorded support sessions and patient and practitioner interviews .
METHODS	At the time of writing the study has recruited 60 patients .
CONCLUSIONS	The feasibility outcomes will inform a definitive RCT to assess the clinical and cost-effectiveness of the augmented BAcPAc written self-help intervention to reduce depression and depressive relapse , and bring about improvements across a range of physical health outcomes .
BACKGROUND	Current Controlled Trials ISRCTN74390532 , 26.03.2013 .

###24885958
BACKGROUND	Job rotation has often been used in situations where the level of exposure can not be reduced due to the characteristics of the job or through physical measures .
BACKGROUND	However , the effectiveness of the job rotation strategy at preventing musculoskeletal complaints lacks adequate scientific data .
METHODS	A cluster randomized controlled trial will be used to investigate the effectiveness of job rotation to prevent musculoskeletal disorders in industrial workers .
METHODS	The randomized cluster was based in characteristics of production sectors .
METHODS	A total cluster will be 4 sectors , and 957 workers will be recruited from a textile industry and randomly allocated into intervention or control groups .
METHODS	Both groups will receive training on ergonomics guidelines .
METHODS	In addition , the intervention group will perform job rotation , switching between tasks with low , moderate , and high risk for musculoskeletal complaints .
METHODS	The primary outcome will be the number of working hours lost due to sick leave by musculoskeletal injuries recorded in employee administrative data bases .
METHODS	Secondary outcomes measured via survey include : body parts with musculoskeletal pain , the intensity of this pain , physical workload , fatigue , general health status , physical activity level , and work productivity .
METHODS	Secondary outcome measures will be assessed at baseline and after 3 , 6 , 9 , and 12 months .
METHODS	The cost-effectiveness analysis will be performed from the societal and company perspective .
CONCLUSIONS	Prevention of work-related musculoskeletal disorders is beneficial for workers , employers , and society .
CONCLUSIONS	The results of this study will provide new information about the effectiveness of job rotation as a strategy to reduce work-related musculoskeletal disorders .
BACKGROUND	NCT01979731 , November 3 , 2013 .

###26020764
BACKGROUND	Avoidance of death , disability , dementia , and cognitive dysfunction ( DDCD ) are high priorities for people in aging societies .
BACKGROUND	Evidence is mounting that these conditions are associated with impaired glycemic control .
OBJECTIVE	The aim of this study was to assess the strength of relationship between the degree of glucose elevation and the development of the composite elements of DDCD that impede successful/healthy aging in a population at high risk for cardiovascular disease .
OBJECTIVE	DESIGN , SETTING , PARTICIPANTS , AND MAIN OUTCOME MEASURE : The relationship between baseline fasting plasma glucose values and DDCD was determined among 31 227 participants of the Ongoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial/Telmisartan Randomized Assessment Study in ACE intolerant Subjects With Cardiovascular Disease studies followed up for a median of 4.7 years .
OBJECTIVE	Several statistical models were used for the entire cohort and for those with and without normal fasting plasma glucose ( ie , < 5.6 mmol/L ) or a history of diabetes mellitus .
RESULTS	After adjusting for age and sex , a diagnosis of diabetes mellitus was associated with an approximately 1.6 greater odds of DDCD ; every 1 mmol/L higher baseline fasting plasma glucose value was associated with a 1.09 ( 95 % confidence interval 1.07 , 1.10 ) greater odds .
RESULTS	These associations persisted in the multivariate models ( a 1.08 95 % confidence interval 1.07 , 1.1 greater odds after adjustment for age , sex , education , and depression ) .
CONCLUSIONS	In individuals with high cardiovascular risk , a direct relationship exists between levels of dysglycemia and the risk of DDCD .
CONCLUSIONS	Further research is needed to understand the mechanisms underlying such an association and whether benefits can be derived from preventative strategies .

###24670086
BACKGROUND	Cystic fibrosis-related diabetes is characterized by postprandial , rather than fasting , hyperglycemia .
BACKGROUND	Gastric emptying and the release of the incretin hormones [ glucagon-like peptide-1 ( GLP-1 ) and glucose dependent insulinotropic polypeptide ( GIP ) ] are central to postprandial glycemic control .
BACKGROUND	Lipolysis is required for fat to slow gastric emptying and stimulate incretin release .
OBJECTIVE	We aimed to determine the effect of pancreatic enzyme replacement therapy ( PERT ) on postprandial glycemia in adolescents with cystic fibrosis ( CF ) .
METHODS	This was a double-blinded randomized crossover trial .
METHODS	Subjects consumed a high-fat pancake , with either PERT ( 50 000 IU lipase ) or placebo .
METHODS	Gastric emptying was measured by a breath test and blood sampled frequently for plasma blood glucose , insulin , glucagon , GLP-1 , and GIP .
METHODS	Data were also compared with seven healthy subjects .
METHODS	Fourteen adolescents ( 13.1 2.7 y ) with pancreatic-insufficient CF and seven healthy age-matched controls participated in the study .
METHODS	Postprandial hyperglycemia was measured as peak glucose and area under the curve for blood glucose at 240 minutes .
RESULTS	CF subjects had postprandial hyperglycemia compared with controls ( area under the curve , P < .0001 ) .
RESULTS	PERT reduced postprandial hyperglycemia ( P = .0002 ) , slowed gastric emptying ( P = .003 ) , and normalized GLP-1 and GIP secretion ( P < .001 for each ) when compared with placebo , without affecting insulin .
CONCLUSIONS	In young people with pancreatic insufficient CF , PERT markedly attenuates postprandial hyperglycemia by slowing gastric emptying and augmenting incretin hormone secretion .

###24351534
OBJECTIVE	To observe the effects of glutamine combined with ulinastatin on inflammatory response of patients with severe burn injury .
METHODS	Sixty patients with severe burn injury admitted to our burn wards from January 2010 to December 2011 conforming to the study criteria were divided into control group ( C , n = 20 ) , glutamine group ( G , n = 20 ) , and glutamine combined with ulinastatin group ( G + U , n = 20 ) according to the random number table .
METHODS	Another 10 healthy volunteers were chosen as normal control group ( NC ) .
METHODS	Isonitrogenous and isocaloric nutrition supports were given to patients in groups C , G , and G + U from post burn day ( PBD ) 2.0.3 g/kg protein in the form of glutamine dipeptide was given to patients in group G for 10 days .
METHODS	0.3 g/kg protein was given to patients in group G + U for 10 days with the same amount of glutamine dipeptide as that in group G , followed by intravenous injection of 100 kU ulinastatin ( once per 8 hours ) for 7 days during 10 days .
METHODS	The nitrogen concentration of 24 h urine was determined with Kieldahl nitrogen determination method , and nitrogen balance was calculated one day before treatment and ten days after treatment .
METHODS	Meanwhile , the levels of D-lactate in serum was determined by colorimetric method , the levels of diamine oxidase ( DAO ) , TNF - , and IL-6 by enzyme-linked immunosorbent assay , and LPS level by kinetic turbidimetric assay with TAL .
METHODS	Above-mentioned indexes were also examined in group NC .
METHODS	The wound healing rate on PBD 30 , total hospital stay days , and the incidence of burn sepsis of all burn patients were recorded .
METHODS	Data were processed with one-way analysis of variance , LSD test , t test , and chi-square test .
RESULTS	Compared with that in group C [ ( -5.40 1.67 ) g/d ] , nitrogen balance in group G was significantly increased ten days after treatment [ ( -1.35 0.59 ) g/d , P < 0.01 ] .
RESULTS	The serum levels of D-lactate , DAO , LPS , TNF - , and IL-6 in group G ten days after treatment were significantly lower than those in group C ( P < 0.05 or P < 0.01 ) .
RESULTS	No statistically significant difference was observed in nitrogen balance and the serum levels of D-lactate , DAO between group G + U and group G ( P values all above 0.05 ) .
RESULTS	The serum levels of LPS , TNF - , and IL-6 in group G + U ten days after treatment were respectively ( 0.167 0.064 ) EU/mL , ( 43 14 ) pg/mL , ( 139 23 ) pg/mL , which were significantly lower than those in group G [ ( 0.240 0.079 ) EU/mL , ( 59 8 ) pg/mL , ( 195 31 ) pg/mL , respectively , P < 0.05 or P < 0.01 ] .
RESULTS	The would healing rate on PBD 30 and total hospital stay days in group G were respectively higher and shorter than those in group C ( P values all below 0.01 ) , but no statistically significant difference in the incidence of burn sepsis was found between them ( P > 0.05 ) .
RESULTS	The would healing rate on PBD 30 in group G+U [ ( 96 4 ) % ] was enhanced , and total hospital stay days [ ( 41 4 ) d ] were lowered than those in group G [ ( 88 7 ) % , ( 49 5 ) d , P values all below 0.01 ] .
RESULTS	The incidence of burn sepsis of patients in group G + U ( 5 % ) was significantly lower than that in group C ( 35 % , ( 2 ) = 6.234 , P < 0.05 ) .
CONCLUSIONS	Glutamine combined with ulinastatin treatment can alleviate damage to intestine after severe burn injury , lower the serum level of inflammatory cytokines , promote wound healing , and reduce the incidence of burn sepsis .

###25005674
OBJECTIVE	The Food Insulin Index ( FII ) is a novel algorithm for ranking foods on the basis of insulin responses in healthy subjects relative to an isoenergetic reference food .
OBJECTIVE	Our aim was to compare postprandial glycemic responses in adults with type 1 diabetes who used both carbohydrate counting and the FII algorithm to estimate the insulin dosage for a variety of protein-containing foods .
METHODS	A total of 11 adults on insulin pump therapy consumed six individual foods ( steak , battered fish , poached eggs , low-fat yoghurt , baked beans and peanuts ) on two occasions in random order , with the insulin dose determined once by the FII algorithm and once with carbohydrate counting .
METHODS	Postprandial glycemia was measured in capillary blood glucose samples at 15-30 min intervals over 3h .
METHODS	Researchers and participants were blinded to treatment .
RESULTS	Compared with carbohydrate counting , the FII algorithm significantly reduced the mean blood glucose level ( 5.70.2 vs 6.50.2 mmol/l , P = 0.003 ) and the mean change in blood glucose level ( -0.70.2 vs 0.10.2 mmol/l , P = 0.001 ) .
RESULTS	Peak blood glucose was reached earlier using the FII algorithm than using carbohydrate counting ( 345 vs 567min , P = 0.007 ) .
RESULTS	The risk of hypoglycemia was similar in both treatments ( 48 % vs 33 % for FII vs carbohydrate counting , respectively , P = 0.155 ) .
CONCLUSIONS	In adults with type 1 diabetes , compared with carbohydrate counting , the novel FII algorithm improved postprandial hyperglycemia after consumption of protein-containing foods .

###24731498
OBJECTIVE	To explore the safety in inguinal incarcerated hernia repair without use of antibiotics .
METHODS	Retrospective statistical analysis was performed for a total 326 patients with inguinal incarcerated hernia repair at our hospital from January 2011 to July 2013 .
METHODS	They were divided into 2 groups of non-using ( n = 192 ) and using ( n = 134 ) antibiotics .
METHODS	Statistical analysis of early postoperative infection was performed for two groups .
RESULTS	The total incision infection had no statistical difference between two groups ( 7.29 % ( 14/192 ) vs 3.73 % ( 5/134 ) , 0.52 % ( 1/192 ) vs 1.49 % ( 2/134 ) , both P > 0.05 ) .
RESULTS	Further comparison of leukocyte count and neutrophil count at Day 3 showed no inter-group statistical difference ( ( 7.9 0.6 ) 10 ( 9 ) vs ( 7.8 0.7 ) 10 ( 9 ) / L , ( 4.9 0.5 ) 10 ( 9 ) vs ( 5.0 0.5 ) 10 ( 9 ) / L ; U = 1.344 , 1.777 ; P = 0.180 , 0.077 ) .
CONCLUSIONS	It is unnecessary to use preventive antibiotics in patients undergoing tension-free repair with incarcerated inguinal hernia without high-risk infection or bowel necrosis .

###24592904
OBJECTIVE	To propose and evaluate a novel surgical approach with minimal trauma , termed interseptal bone reduction , combined with the use of a conventional orthodontic fixed appliance to accelerate canine retraction .
METHODS	A split-mouth design study was conducted in 18 female subjects ( mean age , 21.9 years ) whose bilateral upper first premolars were extracted and who subsequently received canine distalization .
METHODS	The extraction socket on the experimental side was deepened , and interseptal bone distal to the maxillary canine was reduced in thickness using a surgical bur ; conventional extraction was performed on the control side .
METHODS	The canines were then distalized using elastomeric chains on both the labial and palatal sides , with a net force of 150 g.
METHODS	The extent of canine movement and rotation was determined from study models , and the angulation was analyzed based on lateral cephalograms .
RESULTS	A Wilcoxon signed rank test demonstrated that the extent of canine movement in the mesio-distal direction after 3 months was significantly greater on the experimental side than on the control side ( 5.4 and 3.4 mm , respectively , P = .002 ) .
RESULTS	However , there was no statistically significant difference in canine angulation or rotation after 3 months between the experimental and control sides .
CONCLUSIONS	In combination with the use of conventional orthodontic appliances , interseptal bone reduction can enhance the rate of canine movement when interseptal bone is sufficiently reduced in both thickness and depth following surgical criteria .

###24660834
BACKGROUND	Patients with left ventricular diastolic dysfunction ( LVDD ) are at increased risk of postoperative adverse events .
BACKGROUND	The primary aim of this study was to evaluate the safety and feasibility of using echocardiography-guided hemodynamic management ( EGHEM ) during surgery in subjects with LVDD compared to conventional management .
BACKGROUND	The feasibility of using echocardiography to direct a treatment algorithm and clinical outcomes were compared for safety between groups .
METHODS	Subjects were screened for LVDD by preoperative transthoracic echocardiography ( TTE ) and randomized to the conventional or EGHEM group .
METHODS	Subjects in EGHEM received hemodynamic management based on left ventricular filling patterns on transesophageal echocardiography ( TEE ) .
METHODS	Primary outcomes measured were the feasibility to obtain TEE images and follow a TEE-based treatment algorithm .
METHODS	Safety outcomes also compared the following clinical differences between groups : length of hospitalization , incidence of atrial fibrillation , congestive heart failure ( CHF ) , myocardial infarction , cerebrovascular accident , transient ischemic attack and renal failure measured 30 days postoperatively .
RESULTS	Population consisted of 28 surgical subjects ( 14 in conventional group and 14 in EGHEM group ) .
RESULTS	Mean subject age was 73.4 6.7 years ( 36 % male ) in conventional group and 65.9 14.4 years ( 36 % male ) in EGHEM group .
RESULTS	Procedures included orthopedic ( conventional = 29 % , EGHEM 36 % ) , general ( conventional = 50 % , EGHEM = 36 % ) , vascular ( conventional = 7 % , EGHEM = 21 % ) , and thoracic ( conventional = 14 % , EGHEM = 7 % ) .
RESULTS	There was no statistically significant difference in adverse clinical events between the 2 groups .
RESULTS	The EGHEM group had less CHF , atrial fibrillation , and shorter length of stay .
CONCLUSIONS	Echocardiography-guided hemodynamic management of patients with LVDD during surgery is feasible and may be a safe alternative to conventional management .

###24314222
OBJECTIVE	To analyze the efficacy and safety of combination of rh-endostatin ( Endostar ) with docetaxel treatment on patients of non-small cell lung cancer ( NSCLC ) who presented PD or intolerable toxicity in/after first-line chemotherapy .
METHODS	A randomized , double-blind , placebo-controlled and multi-center clinical trial was conducted .
METHODS	Patients with stage IIIB/IV of NSCLC experienced previous chemotherapy of one-regimen were screened for this trial .
METHODS	A total of 68 cases were included in this study .
METHODS	Single docetaxel and that combined with endostar were conducted in two arms .
METHODS	The response , time to progression ( TTP ) and adverse effects were observed in both arms .
RESULTS	The objective response rate ( ORR ) and clinical benefit rate ( CBR ) were 0 and 62.5 % in the combined arm , along with 0 and 53.3 % in the single docetaxel arm , with a non-significant difference between the two groups ( all P > 0.05 ) , respectively .
RESULTS	The median TTPs in the combined and single docetaxel arms were 2.63 and 2.07 months , respectively ( P = 0.079 ) .
RESULTS	The median TTPs of the participants with progressive disease ( PD ) after first-line chemotherapy were 1.33 and 1.67 months in the combined and single docetaxel arms , respectively ( P = 0.946 ) .
RESULTS	The median TTPs of the participants with intolerant adverse effects in first-line chemotherapy were 4.70 months and 3.17 months in the combined and single docetaxel arms , respectively ( P = 0.070 ) .
RESULTS	The median TTPs of the patients with SD after 2 therapeutic cycles in the combined and single docetaxel arms were 6.23 months and 3.27 months , respectively ( P = 0.040 ) .
RESULTS	The differences between two arms were non-significant in adverse , serious adverse and cardiovascular adverse effects ( all P > 0.05 ) .
CONCLUSIONS	Endostar may prolong TTP in patients with advanced NSCLC benefited from docetaxel treatment without increased toxicities .

###24423751
OBJECTIVE	To assess subjective preference using three nasal hygiene systems : Strimar Original ( ) , Emcur ( ) and Sinus Rinse .
METHODS	We used a prospective , single-blind , randomised , crossover study to compare three nasal hygiene systems : Strimar Original , Emcur and Sinus Rinse .
METHODS	Eighteen adult volunteers were recruited and were asked to rate their experience over three days using three well-established nasal hygiene systems .
METHODS	A standard visual analogue scale was used to assess five criteria : ( 1 ) simplicity of instructions ; ( 2 ) ease of use ; ( 3 ) comfort ; ( 4 ) perceived nasal clearance ( effectiveness ) and ( 5 ) single best overall system .
RESULTS	Strimar Original was found to have the easiest instructions to understand compared to the other two systems .
RESULTS	There was no significant difference between Strimar Original and Sinus Rinse with regards to ease of use but they were both significantly easier to use than Emcur ( p < 0.05 ) .
RESULTS	There was no statistically significant difference between the three systems when comparing the last three criteria .
RESULTS	There was no alteration in preference when the cost of each treatment was disclosed to the subjects , and no significant side effects were reported .
CONCLUSIONS	The instructions accompanying Strimar Original appeared to be the easiest to understand , while Strimar Original and Sinus Rinse were easier to use than Emcur .

###25223986
BACKGROUND	Metastases-directed therapy ( MDT ) with surgery or stereotactic body radiotherapy ( SBRT ) is emerging as a new treatment option for prostate cancer ( PCa ) patients with a limited number of metastases ( 3 ) at recurrence - so called `` oligometastases '' .
BACKGROUND	One of the goals of this approach is to delay the start of palliative androgen deprivation therapy ( ADT ) , with its negative impact on quality of life .
BACKGROUND	However , the lack of a control group , selection bias and the use of adjuvant androgen deprivation therapy prevent strong conclusions from published studies.The aim of this multicenter randomized phase II trial is to assess the impact of MTD on the start of palliative ADT compared to patients undergoing active surveillance .
METHODS	Patients with an oligometastatic recurrence , diagnosed on choline PET/CT after local treatment with curative intent , will be randomised in a 1:1 ratio between arm A : active surveillance only and arm B : MTD followed by active surveillance .
METHODS	Patients will be stratified according to the location of metastasis ( node vs. bone metastases ) and PSA doubling time ( 3 vs. > 3 months ) .
METHODS	Both surgery and SBRT are allowed as MDT .
METHODS	Active surveillance means 3-monthly PSA testing and re-imaging at PSA progression .
METHODS	The primary endpoint is ADT-free survival .
METHODS	ADT will be started in both arms at time of polymetastatic disease ( > 3 metastatic lesions ) , local progression or symptoms .
METHODS	The secondary endpoints include progression-free survival , quality of life , toxicity and prostate-cancer specific survival .
CONCLUSIONS	This is the first randomized phase 2 trial assessing the possibility of deferring palliative ADT with MDT in oligometastatic PCa recurrence .
BACKGROUND	Clinicaltrials.gov identifier : NCT01558427 .

###25118597
OBJECTIVE	Sclerostin is secreted by osteocytes .
OBJECTIVE	As a circulating inhibitor of the Wnt-signaling pathway it inhibits bone formation and contributes to the development of osteoporosis .
OBJECTIVE	Sclerostin levels are elevated in patients with chronic kidney disease and end-stage renal disease .
OBJECTIVE	Since data for patients after kidney transplantation are scarce , we have prospectively measured sclerostin levels before and during the first year after renal transplantation and have examined the association of sclerostin with parameters of bone mineral metabolism and with bone mineral density .
METHODS	Sclerostin levels were measured by ELISA in 42 consecutive renal transplant recipients before and at defined intervals in the first year after transplantation .
METHODS	Bone mineral density was measured by dual energy X-ray absorptiometry .
RESULTS	Pre-transplant serum sclerostin levels were elevated in all patients ( 61.8 32.3 pmol/l , normal range 20-30 pmol/l ) .
RESULTS	Within 15 days after transplantation and correlating with the improvement of renal function , sclerostin levels dropped to 21.0 14.7 pmol/l and subsequently increased to 23.8 14.9 and 28.0 16.8 pmol/l after 6 and 12 months , respectively ( P < 0.001 ) .
RESULTS	A linear mixed model indicated that pre-transplant sclerostin levels ( P < 0.001 ) and time after transplantation ( P < 0.001 ) were the most important predictors for the rise of post-transplant sclerostin levels .
RESULTS	No correlation was found between post-transplant sclerostin levels and bone mineral density .
CONCLUSIONS	The rapid reduction of elevated serum sclerostin levels shortly after kidney transplantation parallels the improvement of renal function , but contrasts with the more delayed improvement of hyperparathyroidism .
CONCLUSIONS	The normalization of both hormones could contribute to improved bone health after renal transplantation .

###25140044
BACKGROUND	Lung age , a simple concept for patients to grasp , is frequently used as an aid in smoking cessation programs .
BACKGROUND	Lung age equations should be continuously updated and should be made relevant for target populations .
BACKGROUND	We observed how new lung age equations developed for Australian populations performed when utilizing the Burden of Obstructive Lung Disease ( BOLD ) - Australia dataset compared to more commonly used equations .
METHODS	Data from a cross-sectional population study of noninstitutionalized Australians aged 40 years with analysis restricted to Caucasians < 75 years .
METHODS	Lung age calculated using equations developed by Newbury et al. and Morris and Temple was compared with chronological age by smoking status and within smoking status .
RESULTS	There were 2,793 participants with a mean age of 57 ( 10 SD ) years .
RESULTS	More than half ( 52 % ) ever smoked , and 10.4 % were current smokers .
RESULTS	Prevalence of chronic obstructive pulmonary disease stage I or higher was 13.4 % ( 95 % confidence interval = 12.2 , 14.7 ) .
RESULTS	For both genders , newer Newbury equations estimated lung ages significantly higher than actual age across all smoking groups ( p < .05 ) .
RESULTS	Morris and Temple equations resulted in lung age estimates significantly lower than chronological age for nonsmokers ( p < .05 ) but no difference among current smokers .
RESULTS	Both equations showed exposure to smoking had lung ages higher than never-smokers ( p < .001 ) .
RESULTS	Lung age also increased with increased pack-years .
CONCLUSIONS	This supports the use of updated equations suited to the population of interest .
CONCLUSIONS	The Australian Newbury equations performed well in the BOLD-Australia dataset , providing more meaningful lung age profile compared to chronological age among smokers .
CONCLUSIONS	Using equations not developed or ideally suited for our population is likely to produce misleading results .

###24392086
BACKGROUND	There is significant morbidity and mortality caused by the complications of osteoporosis , for which ageing is the greatest epidemiological risk factor .
BACKGROUND	Preventive medications to delay osteoporosis are available , but little is known about motivators to adhere to these in the context of a symptomless condition with evidence based on screening results .
OBJECTIVE	To describe key perceptions that influence older women 's adherence and persistence with prescribed medication when identified to be at a higher than average risk of fracture .
METHODS	A longitudinal qualitative study embedded within a multi-centre trial exploring the effectiveness of screening for prevention of fractures .
METHODS	Primary care , Norfolk .
METHODS	United Kingdom .
METHODS	Thirty older women aged 70-85 years of age who were offered preventive medication for osteoporosis and agreed to undertake two interviews at 6 and 24 months post-first prescription .
RESULTS	There were no overall predictors of adherence which varied markedly over time .
RESULTS	Participants ' perceptions and motivations to persist with medication were influenced by six core themes : understanding adherence and non-adherence , motivations and self-care , appraising and prioritising risk , anticipating and managing side effects , problems of understanding , and decision making around medication .
RESULTS	Those engaged with supportive professionals could better tolerate and overcome barriers such as side-effects .
CONCLUSIONS	Many issues are raised following screening in a cohort of women who have not previously sought advice about their bone health .
CONCLUSIONS	Adherence to preventive medication for osteoporosis is complex and multifaceted .
CONCLUSIONS	Individual participant understanding , choice , risk and perceived need all interact to produce unpredictable patterns of usage and acceptability .
CONCLUSIONS	There are clear implications for practice and health professionals should not assume adherence in any older women prescribed medication for the prevention of osteoporosis .
CONCLUSIONS	The beliefs and motivations of participants and their healthcare providers regarding the need to establish acceptable medication regimes is key to promoting and sustaining adherence .

###24316699
OBJECTIVE	To evaluate the efficacy of Oraqix during scaling and root planing ( SRP ) in comparison with 20 % benzocaine and placebo .
METHODS	15 patients requiring 4 sessions of SRP were enrolled .
METHODS	For each patient , Oraqix , Hurricaine , vaseline or no anesthetic product were randomly assigned each to a quadrant .
METHODS	Treatment pain was evaluated on a 100 mm Visual Analog Scale ( VAS ) and on a Verbal Rating Scale ( VRS ) .
METHODS	The amount of product administered , the need to re-anesthetise , patient and operator satisfaction and the onset of side-effects were also recorded .
RESULTS	Oraqix was significantly better than nothing , with a reduction of VAS score to 13.3 units , but without significant differences with Vaseline or Hurricaine .
RESULTS	Oraqix was better in VRS reduction than not using any anesthetic ( p = 0.001 ) or using vaseline ( p = 0.024 ) , but similar to Hurricaine ( p = 0.232 ) .
CONCLUSIONS	Oraqix effectively controls pain in SRP procedures , with few side-effects and a good acceptance on the part of patients and clinicians .

###24477462
OBJECTIVE	Superficial fungal skin infections are treated using topical antifungals .
OBJECTIVE	The aim of this study was to demonstrate the efficacy of a single application of 1 % terbinafine film-forming solution ( FFS ) versus placebo for the treatment of tinea pedis in the Chinese population .
METHODS	Six centers in China randomized 290 patients in a 1:1 ratio to receive either 1 % terbinafine FFS or FFS vehicle ( placebo ) once on the affected foot/feet .
METHODS	Efficacy assessments included microscopy and mycologic culture , and assessing clinical signs and symptoms at baseline , and at weeks 1 and 6 after the topical treatment .
METHODS	All adverse events were recorded .
RESULTS	At week 6 , 1 % terbinafine FFS was superior to placebo for effective treatment rate ( 63 vs. 8 % ) ; clinical cure ( 30 vs. 6 % ) ; mycological cure ( 86 vs. 12 % ) ; negative microscopy ( 90 vs. 24 % ) ; and negative mycological culture ( 90 vs. 27 % ) : all p 0.001 and clinically relevant .
RESULTS	At week 6 , 1 % terbinafine FFS was clinically superior to placebo for the absence of : erythema ( 69 vs. 29 % ) ; desquamation ( 33 vs. 8 % ) ; and pruritus ( 70 vs. 30 % ) : all p 0.001 and clinically relevant .
RESULTS	At week 6 , differences in the average total signs and symptoms scores were significantly lower for 1 % terbinafine FFS versus placebo ( p 0.001 ) .
RESULTS	Both 1 % terbinafine FFS and placebo were safe and well tolerated based on adverse events and investigator and patient assessments .
CONCLUSIONS	This double-blind , randomized , multicenter study demonstrated one single topical application of 1 % terbinafine FFS was safe and effective in the treatment of tinea pedis in the Chinese population .

###25488303
BACKGROUND	Postoperative nausea and vomiting ( PONV ) is common ; ondansetron is often used as prophylaxis or for breakthrough episodes .
BACKGROUND	Vestipitant is a neurokinin 1 ( NK-1 ) receptor antagonist that is effective for prophylaxis , but its efficacy for treating established PONV is unknown .
BACKGROUND	This study was performed to evaluate the efficacy and safety of vestipitant , compared with ondansetron for the treatment of breakthrough PONV in patients who had already received prophylactic ondansetron before surgery .
METHODS	A multicentre , randomized , single-blind ( sponsor-open ) , parallel group study .
METHODS	Of 527 surgical patients , 130 ( 25 % ) had breakthrough PONV and were equally randomized to one of six i.v. doses of vestipitant ( 4-36 mg ) or ondansetron 4 mg .
METHODS	The primary endpoint was the rate of patients exhibiting complete response , defined as no emesis and no further rescue medication from 10 min after infusion up to 24 h after surgery or hospital discharge .
RESULTS	All doses of vestipitant were non-inferior to ondansetron in treating PONV after failed prophylaxis with ondansetron .
RESULTS	However , vestipitant was superior to ondansetron in decreasing episodes of postoperative emesis and retching .
RESULTS	The complete response rate analysis using Bayesian model averaging indicated that no vestipitant dose was superior to ondansetron .
RESULTS	Nausea numerical rating scale scores and the times-to-PONV or discharge were similar between the vestipitant and ondansetron treatment groups .
CONCLUSIONS	Although overall efficacy was non-inferior between vestipitant and ondansetron , the rate of emesis was lower with vestipitant .
CONCLUSIONS	These data suggest that vestipitant may be a useful agent for the management of PONV , similar to other NK-1 antagonists .
BACKGROUND	NCT01507194 .

###24473957
OBJECTIVE	To evaluate the impact of manual vibrocompression and nasotracheal suctioning on heart ( hr ) and respiratory ( rr ) rates , peripheral oxygen saturation ( SpO ( 2 ) ) , pain and respiratory distress in infants in the postoperative period of a cardiac surgery .
METHODS	Randomized controlled trial , in which the assessments were performed by the same physiotherapist in two moments : before and after the procedure .
METHODS	The infants were randomly divided into two groups : Intervention ( IG ) , with manual chest vibrocompression , nasotracheal suctioning and resting ; and Control CG ) , with 30 minutes of rest .
METHODS	Cardiorespiratory data ( SpO ( 2 ) ; hr ; rr ) were monitored and the following scales were used : Neonatal Infant Pain Scale ( NIPS ) , for pain evaluation , and Bulletin of Silverman-Andersen ( BSA ) , for respiratory distress assessment .
METHODS	The data were verified by analysis of variance ( ANOVA ) for repeated measures , being significant p < 0.05 .
RESULTS	20 infants with heart disease , ten in each group ( seven acyanotic and three cyanotic ) were enrolled , with ages ranging from zero to 12 months .
RESULTS	In the analysis of the interaction between group and time , there was a significant difference in the variation of SpO ( 2 ) ( p = 0.016 ) , without changes in the other variables .
RESULTS	Considering the main effect on time , only rr showed a significant difference ( p = 0.001 ) .
RESULTS	As for the group main effect , there were no statistical differences ( SpO ( 2 ) - p = 0.77 , hr - p = 0.14 , rr - p = 0.17 , NIPS - p = 0.49 and BSA - p = 0.51 ) .
CONCLUSIONS	The manual vibrocompression and the nasotracheal suctioning applied to infants in postoperative of cardiac surgery did not altered SpO ( 2 ) and rr , and did not trigger pain and respiratory distress .

###26001563
BACKGROUND	In a subset of patients with asthma , standard-of-care treatment does not achieve disease control , highlighting the need for novel therapeutic approaches .
BACKGROUND	Lebrikizumab is a humanised , monoclonal antibody that binds to and blocks interleukin-13 activity .
METHODS	LUTE and VERSE were replicate , randomised , double-blind , placebo-controlled studies , evaluating multiple doses of lebrikizumab in patients with uncontrolled asthma despite the use of medium-to-high-dose inhaled corticosteroid and a second controller .
METHODS	Patients received lebrikizumab 37.5 , 125 , 250mg or placebo subcutaneously every fourweeks .
METHODS	The primary endpoint was the rate of asthma exacerbations during the placebo-controlled period .
METHODS	Analyses were performed on prespecified subgroups based on baseline serum periostin levels .
METHODS	Following the discovery of a host-cell impurity in the study drug material , protocols were amended to convert from phase III to phase IIb .
METHODS	Subsequently , dosing of study medication was discontinued early as a precautionary measure .
METHODS	The data collected for analysis were from a placebo-controlled period of variable duration and pooled across both studies .
RESULTS	The median duration of treatment was approximately 24weeks .
RESULTS	Treatment with lebrikizumab reduced the rate of asthma exacerbations , which was more pronounced in the periostin-high patients ( all doses : 60 % reduction ) than in the periostin-low patients ( all doses : 5 % reduction ) ; no dose-response was evident .
RESULTS	Lung function also improved following lebrikizumab treatment , with greatest increase in FEV1 in periostin-high patients ( all doses : 9.1 % placebo-adjusted improvement ) compared with periostin-low patients ( all doses : 2.6 % placebo-adjusted improvement ) .
RESULTS	Lebrikizumab was well tolerated and no clinically important safety signals were observed .
CONCLUSIONS	These data are consistent with , and extend , previously published results demonstrating the efficacy of lebrikizumab in improving rate of asthma exacerbations and lung function in patients with moderate-to-severe asthma who remain uncontrolled despite current standard-of-care treatment .
BACKGROUND	The LUTE study was registered under NCT01545440 and the VERSE study under NCT01545453 at http://www.clinicaltrials.gov .

###24908429
OBJECTIVE	This study aimed to test whether a very early nutrition intervention delivered over the telephone was feasible and could improve outcomes amongst patients with upper gastrointestinal cancer .
METHODS	Participants with a histologically proven new diagnosis of primary oesophageal or stomach cancer and who were to undergo surgery and/or chemotherapy were randomised to receive either standard nutrition care ( SC ) or early and intensive nutrition intervention ( NI ) over the telephone/face-to-face .
METHODS	Participants were followed for 6 months .
METHODS	The primary outcome was quality of life ( QoL ) , assessed using the European Organization for Research and Treatment of Cancer Global Quality of Life questionnaire C30 ( EORTC QLQ-C30 ) and the European Quality of Life Instrument ( EQ-5D ) tool ; secondary outcomes were nutritional status and survival .
RESULTS	Twenty-one participants were recruited ( 11 SC and 10 NI ) .
RESULTS	At baseline , the prevalence of malnutrition was 90 % .
RESULTS	Compared with SC , the NI group had a significantly higher EORTC global QoL score at the first mid-study follow-up ( coefficient ( 95 % CI ) 21.0 ( 12.1 , 29.9 ) adjusted for baseline , p < 0.001 ) and at 26 weeks ( 28.4 ( 21.3 , 35.4 ) adjusted for baseline , p < 0.001 ) .
RESULTS	Nutritional risk score was lower ( p < 0.001 ) , and loss of body weight attenuated ( p < 0.001 ) in the NI group compared with SC .
RESULTS	Six deaths occurred during the study , five in the SC group and one in the NI group ( p = 0.06 ) .
RESULTS	The mean time spent with a dietitian per contact was significantly less for the NI group compared with SC ( 16 ( 3 ) vs 40 ( 6 ) min per dietetic contact , p < 0.001 ) .
CONCLUSIONS	This pilot study has shown the potential of a novel telephone-based early and intensive dietetic model of care for newly diagnosed upper gastrointestinal cancer patients .

###25358451
BACKGROUND	We investigated the potential benefits of early tracheotomy performed before day eight of mechanical ventilation ( MV ) compared with late tracheotomy ( from day 14 if it still indicated ) in reducing mortality , days of MV , days of sedation and ICU length of stay ( LOS ) .
METHODS	Randomized controlled trial ( RCT ) including all-consecutive ICU admitted patients requiring seven or more days of MV .
METHODS	Between days five to seven of MV , before randomization , the attending physician ( AP ) was consulted about the expected duration of MV and acceptance of tracheotomy according to randomization .
METHODS	Only accepted patients received tracheotomy as result of randomization .
METHODS	An intention to treat analysis was performed including patients accepted for the AP and those rejected without exclusion criteria .
RESULTS	A total of 489 patients were included in the RCT .
RESULTS	Of 245 patients randomized to the early group , the procedure was performed for 167 patients ( 68.2 % ) whereas in the 244 patients randomized to the late group was performed for 135 patients ( 55.3 % ) ( P < 0.004 ) .
RESULTS	Mortality at day 90 was similar in both groups ( 25.7 % versus 29.9 % ) , but duration of sedation was shorter in the early tracheotomy group median 11 days ( range 2 to 92 ) days compared to 14 days ( range 0 to 79 ) in the late group ( P < 0.02 ) .
RESULTS	The AP accepted the protocol of randomization in 205 cases ( 42 % ) , 101 were included in early group and 104 in the late group .
RESULTS	In these subgroup of patients ( per-protocol analysis ) no differences existed in mortality at day 90 between the two groups , but the early group had more ventilator-free days , less duration of sedation and less LOS , than the late group .
CONCLUSIONS	This study shows that early tracheotomy reduces the days of sedation in patients undergoing MV , but was underpowered to prove any other benefit .
CONCLUSIONS	In those patients selected by their attending physicians as potential candidates for a tracheotomy , an early procedure can lessen the days of MV , the days of sedation and LOS .
CONCLUSIONS	However , the imprecision of physicians to select patients who will require prolonged MV challenges the potential benefits of early tracheotomy .
BACKGROUND	Controlled-Trials .
BACKGROUND	com ISRCTN22208087 .
BACKGROUND	Registered 27 March 2014 .

###25252807
BACKGROUND	Fear of Falling ( FoF ) is commonly reported among older adults ( up to 50 % ) and can impact negatively on physical and social activities , mood and quality of life .
BACKGROUND	This paper explores the development , acceptability and feasibility of a cognitive behavioural therapy intervention ( CBTi ) for FoF .
METHODS	The process evaluation of the CBTi development phase of an RCT ( conducted in the UK ) reported here , used ethnographic methods .
METHODS	Data included : interviews with patients and carers ( n = 16 ) , clinic staff ( n = 6 ) and the psychologists developing the CBTi ( n = 3 ) ; observational field notes and transcripts of intervention development meetings ( n = 9 ) and stakeholder engagement meetings ( n = 2 ) ; and informal discussions with staff developing the CBTi ( n = 8 ) .
METHODS	Data collection and thematic analysis were guided by Normalisation Process Theory ( NPT ) .
RESULTS	The process evaluation showed two domains of work necessary to develop a CBTi that made sense to stakeholders , and that could be delivered as part of an RCT .
RESULTS	For the psychologists developing the content of the CBTi , a growing understanding of the complexity of FoF highlighted the need for an individualised rather than a manualised intervention .
RESULTS	For the research team , the work involved adapting the structures and processes of the RCT to address preliminary concerns over the acceptability and feasibility of the proposed CBTi .
CONCLUSIONS	Theory-based approaches to process evaluation can sensitise researchers to contested understandings about proposed interventions that could undermine implementation .
CONCLUSIONS	Drawing on the coherence construct of NPT , this study emphasises the nature and extent of work required to ensure an intervention makes sufficient sense to key stakeholders in order to maximise chances of successful implementation .

###24221463
OBJECTIVE	To determine whether a novel guarded 33-gauge injection device can make the intravitreal injection procedure faster and more comfortable for patients .
METHODS	Single-center , prospective , randomized interventional study .
METHODS	Seventy participants receiving bilateral injections on the same day had one eye injected with the 33-gauge injection device without a speculum and the other eye injected with a standard 30-gauge needle using a speculum .
METHODS	Length of time needed for the injection procedure was assessed , and subjects were asked to complete a questionnaire regarding their comfort level with each device during the injection procedure as well as immediately after , later that evening , and the next day .
RESULTS	Intravitreal injections using the 33-gauge injection device were significantly faster , but there was no significant difference in the incidence or levels of pain between the two needle types .
CONCLUSIONS	The 33-gauge injection device may offer advantages over a standard 30-gauge needle when performing an intravitreal injection .

###25034118
BACKGROUND	Human motivation and decision-making is influenced by the interaction of Pavlovian and instrumental systems .
BACKGROUND	The neurotransmitters dopamine and serotonin have been suggested to play a major role in motivation and decision-making , but how they affect this interaction in humans is largely unknown .
OBJECTIVE	We investigated the effect of these neurotransmitters in a general Pavlovian-to-instrumental transfer ( PIT ) task which measured the nonspecific effect of appetitive and aversive Pavlovian cues on instrumental responses .
METHODS	For that purpose , we used selective dietary depletion of the amino acid precursors of serotonin and dopamine : tryptophan ( n = 34 ) and tyrosine/phenylalanine ( n = 35 ) , respectively , and compared the performance of these groups to a control group ( n = 34 ) receiving a nondepleted ( balanced ) amino acid drink .
RESULTS	We found that PIT differed between groups : Relative to the control group that exhibited only appetitive PIT , we found reduced appetitive PIT in the tyrosine/phenylalanine-depleted group and enhanced aversive PIT in the tryptophan-depleted group .
CONCLUSIONS	These results demonstrate a differential involvement of serotonin and dopamine in motivated behavior .
CONCLUSIONS	They suggest that reductions in serotonin enhance the motivational influence of aversive stimuli on instrumental behavior and do not affect the influence of appetitive stimuli , while reductions in dopamine diminish the influence of appetitive stimuli .
CONCLUSIONS	No conclusions could be drawn about how dopamine affects the influence of aversive stimuli .
CONCLUSIONS	The interplay of both neurotransmitter systems allows for flexible and adaptive responses depending on the behavioral context .

###25858909
BACKGROUND	Some patients with refractory asthma have evidence of uncontrolled eosinophilic inflammation in the distal airways .
BACKGROUND	While traditional formulations of inhaled steroids settle predominantly in the large airways , newer formulations with an extra-fine particle size have a more peripheral pattern of deposition .
BACKGROUND	Specifically treating distal airway inflammation may improve asthma control .
METHODS	30 patients with refractory asthma despite high dose inhaled corticosteroids were identified as having persistent airway eosinophilia .
METHODS	Following 2weeks of prednisolone 30mg , patients demonstrating an improvement in asthma control were randomised to receive either ciclesonide 320g twice daily or placebo in addition to usual maintenance therapy for 8weeks .
METHODS	The primary outcome measure was sputum eosinophil count at week 8 .
METHODS	Alveolar nitric oxide was measured as a marker of distal airway inflammation .
RESULTS	There was continued suppression of differential sputum eosinophil counts with ciclesonide ( median 2.3 % ) but not placebo ( median 4.5 % ) though the between-group difference was not significant .
RESULTS	When patients who had changed their maintenance prednisolone dose during the trial were excluded the difference between groups was significant ( 1.4 % vs 4.5 % , p = 0.028 ) .
RESULTS	Though alveolar nitric oxide decreased with ciclesonide the value did not reach statistical significance .
CONCLUSIONS	These data demonstrate that patients with ongoing eosinophilic inflammation are not truly refractory , and that suppression of airway eosinophilia may be maintained with additional inhaled corticosteroid .
CONCLUSIONS	Further work is needed with a focus on patient-orientated outcome measures such as exacerbation rate , with additional tests of small airway function .
BACKGROUND	NCT01171365 .
BACKGROUND	Protocol available at http://www.clinicaltrials.gov .

###24705615
OBJECTIVE	Plasma adiponectin levels are reduced in type 2 diabetes mellitus ( T2DM ) and other insulin-resistant states .
OBJECTIVE	We examined whether plasma adiponectin levels at baseline and after pioglitazone treatment in impaired glucose tolerance ( IGT ) subjects were associated with improved insulin sensitivity ( SI ) and glucose tolerance status .
METHODS	A total of 602 high-risk IGT subjects in ACT NOW were randomized to receive pioglitazone or placebo with a median follow-up of 2.4 years .
RESULTS	Pioglitazone reduced IGT conversion to diabetes by 72 % in association with improved - cell function by 64 % ( insulin secretion/insulin resistance index ) and increased tissue sensitivity by 88 % ( Matsuda index ) .
RESULTS	In pioglitazone-treated subjects , plasma adiponectin concentration increased threefold from 13 0.5 to 38 2.5 g/mL ( P < 0.001 ) and was strongly correlated with the improvement in SI ( r = 0.436 , P < 0.001 ) and modestly correlated with glucose area under the curve during oral glucose tolerance test ( r = 0.238 , P < 0.005 ) and insulin secretion/insulin resistance index ( r = 0.306 , P < 0.005 ) .
RESULTS	The increase in adiponectin was a strong predictor of reversion to normal glucose tolerance and prevention of T2DM .
RESULTS	In the placebo group , plasma adiponectin did not change and was not correlated with changes in glucose levels .
RESULTS	There was an inverse association between baseline plasma adiponectin concentration and progression to diabetes in the placebo group but not in the pioglitazone group .
CONCLUSIONS	Baseline adiponectin does not predict the response to pioglitazone .
CONCLUSIONS	The increase in plasma adiponectin concentration after pioglitazone therapy in IGT subjects is strongly related to improved glucose tolerance status and enhanced tissue sensitivity to insulin .

###25066269
BACKGROUND	Although CRC is the third most commonly diagnosed cancer in the United States , second-line CRC treatment is limited .
BACKGROUND	In this trial we examined the efficacy and safety of linifanib , an oral , potent , selective tyrosine kinase inhibitor of vascular endothelial growth factor and platelet-derived growth factor receptor families , with mFOLFOX6 , compared with bevacizumab and mFOLFOX6 , in previously treated metastatic CRC .
METHODS	One hundred forty-eight patients with advanced CRC previously treated with fluoropyrimidine or irinotecan received bevacizumab ( 10 mg/kg , intravenous ) , low-dose linifanib ( 7.5 mg ) , or high-dose linifanib ( 12.5 mg ) , with mFOLFOX6 .
METHODS	The primary end point was progression-free survival ( PFS ) .
METHODS	Secondary objectives included overall survival ( OS ) , objective response rate ( ORR ) , and safety .
RESULTS	No statistically significant differences in PFS occurred between bevacizumab and linifanib doses ( low , hazard ratio [ HR ] , 1.453 [ 95 % confidence interval [ CI ] , 0.830-2 .539 ] ; high , HR , 1.257 [ 95 % CI , 0.672-2 .351 ] ) .
RESULTS	Median OS values were similar for bevacizumab and high-dose linifanib ( bevacizumab , 16.5 months [ 95 % CI , 13.0-not available ] ; high-dose linifanib , 16.4 months [ 95 % CI , 11.9-21 .7 ] ; low-dose linifanib , 12.0 months [ 95 % CI , 10.1-13 .0 ] ) .
RESULTS	ORRs were similar ( bevacizumab , 34.7 % [ 95 % CI , 21.7-49 .6 ] ; low-dose linifanib , 24.0 % [ 95 % CI , 13.1-38 .2 ] ; high-dose linifanib , 22.4 % [ 95 % CI , 11.8-36 .6 ] ) .
RESULTS	Median cycles of 5-fluorouracil were reduced in the linifanib arms , versus the bevacizumab arm .
RESULTS	Grade 3/4 adverse event occurrences were more frequent with linifanib .
RESULTS	Palmar-plantar erythrodysesthesia , hypothyroidism , and thrombocytopenia were more common with high-dose linifanib than bevacizumab .
CONCLUSIONS	Combining linifanib with mFOLFOX6 as a second-line treatment for metastatic CRC did not improve PFS , radiographic findings , or duration of response versus bevacizumab and mFOLFOX6 .

###24986217
BACKGROUND	Adolescent substance use and delinquency are major public health problems .
BACKGROUND	Although community-based prevention strategies have been recommended to produce population-level reductions in rates of substance use and delinquency , few models show evidence of effectiveness .
OBJECTIVE	To test the efficacy of a community-based prevention system , Communities That Care ( CTC ) , in reducing community rates of problem behaviors , particularly effects on specific profiles of adolescent substance use and delinquency in eighth - and tenth-graders .
METHODS	Twenty-four communities were randomized to CTC intervention or control groups .
METHODS	Data were collected from 14,099 8th - and 10th-grade students in these communities using anonymous cross-sectional surveys in 2004 and 2010 and analyzed in 2012 .
METHODS	Outcomes were four different profiles of self-reported substance use and delinquency in 8th grade and five profiles in 10th grade .
RESULTS	In the cross-sectional 2010 data , there was no intervention effect on the probability of experimenting with substances or of substance use coupled with delinquent activities for either grade .
RESULTS	However , tenth-graders in intervention communities were significantly less likely to be alcohol users than those in control communities ( OR = 0.69 , CI = 0.48 , 1.00 ) .
CONCLUSIONS	Cross-sectional population surveys showed evidence of CTC effects in reducing tenth-grade alcohol users but not experimenters .
CONCLUSIONS	A community-wide reduction in adolescent alcohol use is important because alcohol is the most commonly used illicit substance during adolescence , and early initiation of alcohol use has been associated with alcohol-related disorders in adulthood .
CONCLUSIONS	Failure to find hypothesized effects on experimenters qualifies these results .

###25629321
OBJECTIVE	Perineural dexamethasone prolongs the duration of single-injection peripheral nerve block when added to the local anesthetic solution .
OBJECTIVE	Postulated systemic mechanisms of action along with theoretical safety concerns have prompted the investigation of intravenous dexamethasone as an alternative , with decidedly mixed results .
OBJECTIVE	We aimed to confirm that addition of intravenous dexamethasone will prolong the duration of analgesia after single-injection supraclavicular block compared with conventional long-acting local anesthetic alone or in combination with perineural dexamethasone for ambulatory upper extremity surgery .
METHODS	Seventy-five patients were randomized to receive supraclavicular block using 30-mL bupivacaine 0.5 % alone ( Control ) , with concomitant intravenous dexamethasone 8 mg ( DexIV ) , or with perineural dexamethasone 8 mg ( DexP ) .
METHODS	Duration of analgesia was designated as the primary outcome .
METHODS	To test our hypothesis , the superiority of DexIV was first compared with Control and then with DexP .
METHODS	Motor block duration , pain scores , opioid consumption , opioid-related side effects , patient satisfaction , and block-related complications were also analyzed .
RESULTS	Twenty-five patients per group were analyzed .
RESULTS	The duration of analgesia ( mean [ 95 % confidence interval ] ) was prolonged in the DexIV group ( 25 hours [ 17.632.4 ] ) compared with Control ( 13.2 hours [ 11.515.0 ] ; P < 0.001 ) but similar to the DexP group ( 25 hours [ 19.530.5 ] ; P = 1 ) .
RESULTS	[ corrected ] Both DexIV and DexP had reduced pain scores , reduced postoperative opioid consumption , and improved satisfaction compared with Control .
CONCLUSIONS	In a single-injection supraclavicular block with long-acting local anesthetic , the effectiveness of intravenous dexamethasone in prolonging the duration of analgesia seems similar to perineural dexamethasone .

###25239343
OBJECTIVE	This prospective , multicenter , randomized clinical trial was performed to compare the effectiveness of the bioprosthesis Surgisis Gold ( Cook Biotech , Inc , West Lafayette , IN ) to suture closure alone in reinforcing the abdominal wall after open Roux-en-Y gastric bypass ( RYGB ) .
METHODS	A total of 402 adult patients ( body mass index 35kg/m ( 2 ) ) scheduled to undergo open RYGB procedures were randomized to receive either Surgisis Gold placed as a sublay directly under and opposed to the posterior rectus fascia without intervening preperitoneal fat or suture closure alone .
METHODS	Peri - and postoperative complications were tracked .
METHODS	Incisional hernia formation in each group was examined at 6weeks , 3 , 6 , and 9months , and 1 and 2years after RYGB .
RESULTS	A total of 380 ( 78 male ; 302 female ) patients with a mean age of 45years ( range 18-69 ) and a mean BMI of 48 ( range 35-79 ) underwent RYGB .
RESULTS	There were no differences in patient demographics or comorbidities between groups .
RESULTS	Placement of the Surgisis Gold increased operating time by an average of 14minutes .
RESULTS	Complications were more common in the Surgisis Gold group with significantly more wound events and seroma formation compared with the suture closure alone group .
RESULTS	At final follow-up , 32 of 185 ( 17 % ) of patients in the reinforced arm and 38 of 195 ( 20 % ) in the suture alone arm developed an incisional hernia ( P = .6 ) .
CONCLUSIONS	In this challenging patient population , the use of Surgisis Gold for reinforcing the abdominal wall after open RYGB was not shown to be greatly different from a primary suture repair .

###24906459
BACKGROUND	Weight loss induced only by exercise is frequently less than expected , possibly because of compensatory changes in energy intake and/or energy expenditure .
BACKGROUND	The purpose of the Examination of Mechanisms ( E-MECHANIC ) of Exercise-Induced Weight Compensation trial is to examine whether increased energy intake and/or reduced spontaneous activity or energy expenditure ( outside of structured exercise ) account for the less than expected , exercise-associated weight loss .
METHODS	E-MECHANIC is a three-arm , 6-month randomized ( 1:1:1 ) controlled trial .
METHODS	The two intervention arms are exercise doses that reflect current recommendations for ( 1 ) general health ( 8 kcal/kg body weight per week ( 8 KKW ) , about 900 kcal/wk ) and ( 2 ) weight loss ( 20 KKW , about 2,250 kcal/wk ) .
METHODS	The third arm , a nonexercise control group , will receive health information only .
METHODS	The sample will include a combined total of 198sedentary , overweight or obese ( body mass index : 25 kg/m to 45 kg/m ) men and women ages 18 to 65 years .
METHODS	The exercise dose will be supervised and tightly controlled in an exercise training laboratory .
METHODS	The primary outcome variables are energy intake , which will be measured using doubly labeled water ( adjusted for change in energy stores ) and laboratory-based food intake tests , and the discrepancy between expected weight loss and observed weight loss .
METHODS	Secondary outcomes include changes in resting metabolic rate ( adjusted for change in body mass ) , activity levels ( excluding structured exercise ) and body composition .
METHODS	In an effort to guide the development of future interventions , the participants will be behaviorally phenotyped and defined as those who do compensate ( that is , fail to lose the amount of weight expected ) or do not compensate ( that is , lose the amount of weight expected or more ) .
CONCLUSIONS	In this study , we will attempt to identify underlying mechanisms to explain why exercise elicits less weight loss than expected .
CONCLUSIONS	This information will guide the development of interventions to increase exercise-induced weight loss and maximize weight loss retention and related health benefits .
BACKGROUND	ClinicalTrials.gov ID : NCT01264406 ( registration date : 20 December 2010 ) .

###26117621
BACKGROUND	We aimed to evaluate whether atrial electromechanical delay ( AEMD ) measured by tissue Doppler imaging ( TDI ) , which is an indicator for structural and electrical remodelling of the atria , is prolonged in patients with active or inactive acromegaly , or both , compared with a control group .
METHODS	A total of 34 patients with acromegaly ( 18 active/16 inactive ) and 35 patients as a control group were enrolled .
METHODS	Both intra - and inter-AEMD were calculated by TDI .
METHODS	The correlation between clinical variables and AEMD were analyzed .
RESULTS	Both inter-AEMD and right and left intra-AEMD were prolonged in patients with acromegaly compared with the control group ( P < 0.001 , P < 0.001 , and P = 0.004 , respectively ) .
RESULTS	Also , patients with active acromegaly showed higher inter-AEMD and right intra-AEMD compared with patients with inactive acromegaly ( P < 0.05 ) .
RESULTS	There was no significant difference in left intra-AEMD between patients with active acromegaly and those with inactive acromegaly ( P = 0.977 ) .
RESULTS	The growth hormone and insulin-like growth factor ( IGF-1 ) levels positively correlated with inter-AEMD ( r = 0.577 ; P < 0.001 ; r = 0.614 ; P < 0.001 , respectively ) .
RESULTS	Additionally , we found that inter-AEMD was significantly and positively correlated with relationship between maximal values of passive mitral inflow ( E , PW-Doppler ) and lateral early diastolic mitral annular velocities ( e ' , TDI ) ( r = 0.316 ; P = 0.008 ) .
RESULTS	Only the serum IGF-1 level was independently associated with inter-AEMD in multivariate linear regression analysis ( = 0.500 ; P = 0.011 ) .
CONCLUSIONS	Our study findings showed that both inter - and intra-AEMD are prolonged in patients with acromegaly .
CONCLUSIONS	Also , AEMD was observed to be more prolonged in patients with active acromegaly than in those with inactive acromegaly .
CONCLUSIONS	IGF-1 was an independent predictor of inter - AEMD in patients with acromegaly .
CONCLUSIONS	Being a noninvasive , inexpensive , and simple technique , AEMD may be used as an indicator for atrial electrical and structural remodelling in patients with acromegaly .

###25325454
OBJECTIVE	Determine effects of low-dose estradiol and low-dose venlafaxine on self-reported sleep measures in menopausal women with hot flashes .
METHODS	3-arm double-blind randomized trial .
METHODS	Participants assigned in a 2:2:3 ratio to 17 estradiol 0.5 mg/day ( n = 97 ) , venlafaxine XR 75 mg/day ( n = 96 ) , or placebo ( n = 146 ) for 8 weeks .
METHODS	Academic research centers .
METHODS	339 community-dwelling perimenopausal and postmenopausal women with 2 bothersome hot flashes per day .
RESULTS	Insomnia symptoms ( Insomnia Severity Index [ ISI ] ) and sleep quality ( Pittsburgh Sleep Quality Index [ PSQI ] ) at baseline , week 4 and 8 ; 325 women ( 96 % ) provided ISI data and 312 women ( 92 % ) provided PSQI data at baseline and follow-up .
RESULTS	At baseline , mean ( SD ) hot flash frequency was 8.1 / day ( 5.3 ) , mean ISI was 11.1 ( 6.0 ) , and mean PSQI was 7.5 ( 3.4 ) .
RESULTS	Mean ( 95 % CI ) change from baseline in ISI at week 8 was -4.1 points ( -5.3 to -3.0 ) with estradiol , -5.0 points ( -6.1 to -3.9 ) with venlafaxine , and -3.0 points ( -3.8 to -2.3 ) with placebo ( P overall treatment effect vs. placebo 0.09 for estradiol and 0.007 for venlafaxine ) .
RESULTS	Mean ( 95 % CI ) change from baseline in PSQI at week 8 was -2.2 points ( -2.8 to -1.6 ) with estradiol , -2.3 points ( -2.9 to -1.6 ) with venlafaxine , and -1.2 points ( -1.7 to -0.8 ) with placebo ( P overall treatment effect vs. placebo 0.04 for estradiol and 0.06 for venlafaxine ) .
CONCLUSIONS	Among perimenopausal and postmenopausal women with hot flashes , both low dose oral estradiol and low-dose venlafaxine compared with placebo modestly reduced insomnia symptoms and improved subjective sleep quality .
BACKGROUND	NCT01418209 at www.clinicaltrials.gov .

###24571340
OBJECTIVE	To compare the vaginal cytology of ovulating and non-ovulating queens .
METHODS	The study group comprised 15 queens showing behavioural oestrus .
METHODS	Ovulation was induced in 7 ( dioestrus group ) and 8 were left untreated ( postoestrus group ) .
METHODS	Vaginal smears were collected from all animals prior to ovariohysterectomy on day 7 .
METHODS	Epithelial cells were classified as basal-parabasal , intermediate , superficial , or anucleated superficial cells and counted using computer-assisted image analysis .
METHODS	From each smear , 50 representative vaginal epithelial cells were chosen .
METHODS	Digital images of cells were taken and cell area , cytoplasm area , nucleus area , cell diameter , cell perimeter , nucleus/cytoplasm ratio and red-green-blue ( RGB ) values were measured using image analysis software .
METHODS	Measurement data were compared between groups .
RESULTS	Ovulation induction was successful in all animals .
RESULTS	The swabbing procedure in oestrus did not induce ovulation in any postoestrus queens .
RESULTS	Mean duration of oestrus was 6.65 0.44 and 4.71 0.32 days ( P > 0.05 ) in the postoestrus and dioestrus queens , respectively .
RESULTS	Intermediate cell count averaged 21.43 % in dioestrus cats and 10.76 % in postoestrus cats ( P < 0.05 ) .
RESULTS	Epithelial cells in the postoestrus group had higher cell area , cytoplasm area , cell diameter and cell perimeter measurements ( P < 0.01 ) .
RESULTS	Red ( 90.9 1.6 ) , green ( 76.1 1.3 ) and blue ( 83.6 1.4 ) channel values in postoestrus were higher than the values ( 81.3 0.8 , 65.8 0.9 and 74.0 0.7 , respectively ) in dioestrus ( P < 0.01 ) .
CONCLUSIONS	Induction of ovulation in oestrus queens results in a significant increase in the number of intermediate cells and a significant decrease in both the dimensions and RGB values of vaginal epithelial cells on day 7 .

###24628943
BACKGROUND	Varenicline carries a black box warning for neuropsychiatric adverse events .
OBJECTIVE	We examined varenicline use and past history of major depressive disorder ( MDD ) on depressive symptoms during smoking cessation .
METHODS	This is a secondary analysis of two smoking cessation studies in 152 postmenopausal women who received placebo or nicotine patch , or 78 women who received varenicline with relaxation .
METHODS	Lifetime history of MDD ( LH-MDD ) was assessed at baseline and women with current MDD were excluded .
METHODS	Center for Epidemiologic Study Depression scale ( CESD ) measured depressive symptoms at baseline , 6 and 12 weeks .
RESULTS	Baseline CESD scores were 5.3 +4.4 .
RESULTS	Those with a LH-MDD reported higher CESD scores ( p > .001 ) .
RESULTS	Those taking varenicline reported lower scores over all time periods compared to nicotine or placebo ( p < .01 ) .
RESULTS	The differences between varenicline and the other treatments remained when controlling for LH-MDD , indicating an independent effect .
RESULTS	CESD scores were associated with concurrent smoking status ( p < .001 ) , and with withdrawal symptoms ( p < .001 ) .
CONCLUSIONS	CESD score were lower in those receiving varenicline , whether this is due to an anti-depressant effect , subject selection , use of relaxation or another cause is unknown .
CONCLUSIONS	Varenicline does not increase depressive symptoms during smoking cessation in postmenopausal women without current MDD .
CONCLUSIONS	Subjects with a LH-MDD are susceptible to developing depressive symptoms during smoking cessation , regardless of pharmacologic aid .
CONCLUSIONS	Pharmacologic aids did not increase depression symptoms in this select population of postmenopausal women without current depression .
CONCLUSIONS	Smoking cessation does increase depressive symptoms in those with LH-MDD , though the degree of increase was not clinically meaningful .

###24576686
BACKGROUND	Previous research suggests that testosterone ( T ) plays a key role in shaping competitive and aggressive behavior in humans , possibly by modulating threat-related neural circuitry .
BACKGROUND	However , this research has been limited by the use of T augmentation that fails to account for baseline differences and has been conducted exclusively in women .
BACKGROUND	Thus , the extent to which normal physiologic concentrations of T affect threat-related brain function in men remains unknown .
METHODS	In the current study , we use a novel two-step pharmacologic challenge protocol to overcome these limitations and to evaluate causal modulation of threat - and aggression-related neural circuits by T in healthy young men ( n = 16 ) .
METHODS	First , we controlled for baseline differences in T through administration of a gonadotropin releasing hormone antagonist .
METHODS	Once a common baseline was established across participants , we then administered T to within the normal physiologic range .
METHODS	During this second step of the protocol we acquired functional neuroimaging data to examine the impact of T augmentation on neural circuitry supporting threat and aggression .
RESULTS	Gonadotropin releasing hormone antagonism successfully reduced circulating concentrations of T and brought subjects to a common baseline .
RESULTS	Administration of T rapidly increased circulating T concentrations and was associated with heightened reactivity of the amygdala , hypothalamus , and periaqueductal grey to angry facial expressions .
CONCLUSIONS	These findings provide novel causal evidence that T rapidly potentiates the response of neural circuits mediating threat processing and aggressive behavior in men .

###25458657
BACKGROUND	Survivors of ischemic stroke/transient ischemic attack ( TIA ) are at high risk for other vascular events .
BACKGROUND	We evaluated the impact of 2 types of case management ( hard touch with pharmacist or soft touch with nurse ) added to usual care on global vascular risk .
METHODS	This is a prespecified secondary analysis of a 6-month trial conducted in outpatients with recent stroke/TIA who received usual care and were randomized to additional monthly visits with either nurse case managers ( who counseled patients , monitored risk factors , and communicated results to primary care physicians ) or pharmacist case managers ( who were also able to independently prescribe according to treatment algorithms ) .
METHODS	The Framingham Risk Score [ FRS ] ) and the Cardiovascular Disease Life Expectancy Model ( CDLEM ) were used to estimate 10-year risk of any vascular event at baseline , 6 months ( trial conclusion ) , and 12 months ( 6 months after last trial visit ) .
RESULTS	Mean age of the 275 evaluable patients was 67.6 years .
RESULTS	Both study arms were well balanced at baseline and exhibited reductions in absolute global vascular risk estimates at 6 months : median 4.8 % ( Interquartile range ( IQR ) 0.3 % -11.3 % ) for the pharmacist arm versus 5.1 % ( IQR 1.9 % -12.5 % ) for the nurse arm on the FRS ( P = .44 between arms ) and median 10.0 % ( 0.1 % -31.6 % ) versus 12.5 % ( 2.1 % -30.5 % ) on the CDLEM ( P = .37 ) .
RESULTS	These reductions persisted at 12 months : median 6.4 % ( 1.2 % -11.6 % ) versus 5.5 % ( 2.0 % -12.0 % ) for the FRS ( P = .83 ) and median 8.4 % ( 0.1 % -28.3 % ) versus 13.1 % ( 1.6 % -31.6 % ) on the CDLEM ( P = .20 ) .
CONCLUSIONS	Case management by nonphysician providers is associated with improved global vascular risk in patients with recent stroke/TIA .
CONCLUSIONS	Reductions achieved during the active phase of the trial persisted after trial conclusion .

###24879550
OBJECTIVE	The aim of this study was to compare the effects of ethyl chloride and placebo sprays for reducing pain induced by needle electromyography and changes in parameters of the motor unit action potential during needle electromyography of the upper extremity .
METHODS	Sixty patients were randomized into the ethyl chloride or placebo spray groups .
METHODS	In both groups , spray was applied just before needle electromyography of the flexor carpi radialis , and a visual analog scale to evaluate the pain of needle electromyography and a five-point Likert scale for patient satisfaction and preference for reexamination were compared between the two groups .
METHODS	Then , changes in the amplitude , phases , turns , and duration of the motor unit action potential during needle electromyography of the biceps brachii were compared before and after spraying in each group .
RESULTS	The visual analog scale was significantly lower , and patient satisfaction and preference for reexamination were significantly higher in the ethyl chloride spray group .
RESULTS	Among the parameters of the motor unit action potential , there were no significant changes except for an increased duration after spraying with ethyl chloride .
CONCLUSIONS	Ethyl chloride spray can effectively reduce pain , but it must be used with caution because it may affect parameters of the motor unit action potential during needle electromyography .

###24844622
BACKGROUND	L-Menthol stimulates cutaneous thermoreceptors and induces cool sensations improving thermal comfort but has also been linked to heat storage responses .
BACKGROUND	Therefore , L-Menthol application could lead to a conflict in behavioural and thermoregulatory drivers improving comfort but leading to a higher rate of deep body temperature rise ; the present study examined this possibility .
METHODS	Six untrained male participants ( age 21 [ 1 ] years ; height 1.80 [ 0.07 ] m ; mass 78.9 [ 6.9 ] kg ; surface area 1.98 [ 0.13 ] m2 ) took part .
METHODS	They completed three trials in hot conditions ( 34 C ) where their clothing was sprayed ( CONTROL-SPRAY or MENTHOL-SPRAY ) or not sprayed ( CONTROL ) after a fixed intensity exercise period ( 15-minutes ) , which induced thermal discomfort , before completing a 5 km treadmill time trial ( TT ) .
METHODS	Thermal perception ( thermal sensation and comfort ; TS , TC ) , thermal responses ( aural temperature [ Tau ] , skin temperature [ Tskin ] ) , perceived exertion ( RPE ) , heart rate , pacing ( 1 km split time ) and performance ( TT completion time ) were measured .
RESULTS	MENTHOL-SPRAY induced improvements in TS ( up to 3 km of TT ) and TC ( up to 1 km ) with Tau showing a tendency to be higher than CONTROL-SPRAY ( +0.20 [ 0.29 ] C ) and CONTROL condition ( 0.30 [ 0.34 ] C ) ; this was not statistically significant and the rate of rise in Tau was linear .
RESULTS	Tau was continuing to rise between the 4th and 5th kilometre of the TT .
RESULTS	The other variables were unchanged .
RESULTS	TT completion time and pace were not different : CONTROL 27.92 [ 1.65 ] , CONTROL-SPRAY 28.10 [ 1.12 ] , MENTHOL-SPRAY 27.53 [ 2.85 ] minutes .
CONCLUSIONS	Spraying L-MENTHOL prior to exercise in the heat culminated in improved perception but not altered performance .

###25409546
BACKGROUND	Emergence of artemisinin resistance has raised concerns that the most potent anti-malarial drug may be under threat .
BACKGROUND	Artesunate-amodiaquine ( AS-AQ ) and artemether-lumefantrine ( AL ) are , respectively , the first - and second-line treatments for uncomplicated falciparum malaria in Cte d'Ivoire .
BACKGROUND	Constant monitoring by National Malaria Control Programme ( NMCP ) of drug efficacy is an important tool in establishing rational anti-malarial drug policies in Cte d'Ivoire .
METHODS	In an open label , randomized controlled clinical trial , children and adults were randomized to receive AS-AQ or AL. .
METHODS	Both drug regimens were given for three days , and follow-up was for 42 days .
METHODS	The primary endpoint was the 42-day cure rate and was defined as proportion of patients with PCR-corrected cure rate after 42 days of follow-up .
RESULTS	A total of 383 patients who were attending the Anonkoua-koute ( Abidjan ) , Petit Paris ( Korhogo ) and Libreville ( Man ) hospitals and presenting with symptomatic acute uncomplicated falciparum malaria were randomized to receive AS-AQ ( 188 ) and AL ( 195 ) .
RESULTS	The intention-to-treat analysis showed effectiveness rates of 94.7 % and 96.4 % for AS-AQ and AL , respectively on day 42 .
RESULTS	After adjustment for PCR , these rates were 96.8 % and 99 % , respectively .
RESULTS	At day 42 , in per-protocol analysis , Adequate clinical and parasitological response ( ACPR ) PCR uncorrected was 97.8 % and 97.4 % for AS-AQ and AL , respectively .
RESULTS	The PCR adjusted ACPR was 100 % for each combination and both regimens were well tolerated .
CONCLUSIONS	This study has shown the high efficacy of AS-AQ in patients of all ages with acute uncomplicated falciparum malaria and AS-AQ was non-inferior to AL. .
CONCLUSIONS	Continuous efficacy monitoring is recommended .

###24439972
BACKGROUND	Hypertension management strategies have traditionally focused on `` tailored therapy '' and `` stepped-care '' approaches .
BACKGROUND	These tend to be costly and time consuming and often fail to achieve adequate blood pressure ( BP ) control .
BACKGROUND	The TRIUMPH study aims to investigate the effectiveness , cost-effectiveness , and acceptability of early use of a 3-in-1 BP-lowering pill ( `` Triple Pill '' ) compared with usual care for the management of hypertension .
METHODS	The prospective , open , randomized controlled clinical trial ( n = 700 ) will compare Triple Pill-based strategy to usual care among individuals with persistent mild-to-moderate hypertension ( systolic BP > 140 mm Hg and/or diastolic BP > 90 mm Hg , or systolic BP > 130 mm Hg and/or diastolic BP > 80 mm Hg in patients with diabetes or chronic kidney disease ) on no or minimal drug therapy .
METHODS	The study will be conducted within approximately 20 hospital-based clinics in India .
METHODS	Participants will be randomized to the Triple Pill ( initially strength 1-telmisartan 20 mg , amlodipine 2.5 mg , hydrochlorothiazide 6.25 mg , with the option of subsequent titration to strength 2-telmisartan 40 mg , amlodipine 5 mg , hydrochlorothiazide 12.5 mg ) or continued usual care .
METHODS	Participants will be followed up for 6 months .
METHODS	The primary outcome is the proportion of participants achieving target BP at the end follow-up .
CONCLUSIONS	This study will determine whether early use of a low-dose triple combination therapy has the potential to address some of the challenges in hypertension control through earlier achievement of BP control , better adherence , and fewer adverse effects , in the context of less intensive clinical follow-up .

###24596084
BACKGROUND	The study aim was , for the first time , to conduct a multicenter randomized controlled trial to evaluate the effect of tonsillectomy in patients with IgA nephropathy ( IgAN ) .
METHODS	Patients with biopsy-proven IgAN , proteinuria and low serum creatinine were randomly allocated to receive tonsillectomy combined with steroid pulses ( Group A ; n = 33 ) or steroid pulses alone ( Group B ; n = 39 ) .
METHODS	The primary end points were urinary protein excretion and the disappearance of proteinuria and/or hematuria .
RESULTS	During 12 months from baseline , the percentage decrease in urinary protein excretion was significantly larger in Group A than that in Group B ( P < 0.05 ) .
RESULTS	However , the frequency of the disappearance of proteinuria , hematuria , or both ( clinical remission ) at 12 months was not statistically different between the groups .
RESULTS	Logistic regression analyses revealed the assigned treatment was a significant , independent factor contributing to the disappearance of proteinuria ( odds ratio 2.98 , 95 % CI 1.01-8 .83 , P = 0.049 ) , but did not identify an independent factor in achieving the disappearance of hematuria or clinical remission .
CONCLUSIONS	The results indicate tonsillectomy combined with steroid pulse therapy has no beneficial effect over steroid pulses alone to attenuate hematuria and to increase the incidence of clinical remission .
CONCLUSIONS	Although the antiproteinuric effect was significantly greater in combined therapy , the difference was marginal , and its impact on the renal functional outcome remains to be clarified .

###24623502
BACKGROUND	5-10 % diabetes patients will develop diabetic foot ulceration at some time during the life .
BACKGROUND	The purpose of this study was to compare the effectiveness of Mepilex Lite dressings and vaseline gauze care in the healing of foot ulcers in diabetic patients .
METHODS	This was a randomized controlled trial , and a sample of 50 diabetic patients who had developed foot ulcers was assessed .
METHODS	Comparisons were made regarding parameters related to wound healing , including healing time and wound pain , and also regarding the adverse events .
RESULTS	The results showed that foot ulcers in the study group ( Mepilex Lite , 24 patients ) healed in a median of 49.9 days , which was significantly different from the healing time in the control group ( median , 65.5 days , 26 patients ; P = 0.038 ) .
RESULTS	No statistically significant differences were detected between the 2 groups with pain .
RESULTS	However , Mepilex Lite dressings significantly reduced wound area ( P < 0.05 ) .
CONCLUSIONS	The researchers conclude that Mepilex Lite dressing provides a promising alternative to diabetic foot ulcers and is worthy of further research .

###25637146
OBJECTIVE	To determine the effect of Chinese massage combined with core stability exercises on nonspecific low back pain .
METHODS	In the prospective study , ninety-two participants with nonspecific low back pain were divided into experimental and control group at random , and 46 in each .
METHODS	The experimental group were treated using Chinese massage combined with core stability exercises , while the control group were treated using Chinese massage alone .
METHODS	The two groups were evaluated using visual analog scale and Oswestry disability index at baseline , immediately after two and eight weeks .
METHODS	In addition , the recurrence rate of nonspecific low back pain was evaluated one year after the last intervention .
RESULTS	Two weeks after treatment , both VAS and ODI scores decreased significantly in two groups ( p < 0.05 ) , when compared with the values before treatment , but no difference between the two groups ( p > 0.05 ) .
RESULTS	Eight weeks later , the VAS and ODI scores decreased significantly in both groups ( p < 0.05 ) ; at the same time , both VAS and ODI scores were significantly lower ( p < 0.05 ) in the experimental group than those in the control group .
RESULTS	At the final follow-up , five cases recurred in the experimental group and nineteen cases in the control group , the control group has a significantly higher recurrence rate ( p < 0.05 ) .
CONCLUSIONS	Core stability exercises can improve the therapeutic effect of Chinese massage in treating nonspecific low back pain .

###24372367
OBJECTIVE	To evaluate the acceptability and efficacy of a psycho-educational intervention designed to improve effective coping and reduce symptom severity in children with cancer .
BACKGROUND	Cancer treatments increase survival rates and also cause physical and psychological effects on children with cancer .
BACKGROUND	A psycho-educational intervention is used to assist children and adolescents with these effects and its efficacy has been described in several studies .
METHODS	A randomized controlled trial .
METHODS	Participants being treated were recruited and randomly assigned to two groups from September 2011-February 2013 in Taiwan .
METHODS	The intervention group received a psycho-educational intervention in addition to standard care , while the control group received only standard care .
METHODS	Each participant was assessed using a paediatric cancer coping scale and perceived symptom severity was evaluated at three time points ( baseline , 1 month and 3 months ) .
METHODS	A repeated-measures analysis of variance was used to estimate the effects of intervention .
METHODS	Qualitative findings were analysed using content analysis .
RESULTS	No significant difference in coping scores was found between groups , but the experimental group reported significantly lower scores in gastrointestinal problems and pain .
RESULTS	Most symptoms decreased significantly over time in both groups , except for gastrointestinal problems .
RESULTS	The scores in pain , bone marrow suppression and body image showed significant interaction effects between groups on changes over time .
RESULTS	Qualitative results reported that participants evaluated the intervention positively , especially about receipt of psychological support and learnt coping skills .
CONCLUSIONS	The psycho-educational intervention administered was acceptable for children with cancer and was found to reduce gastrointestinal problems and pain .

###25466242
BACKGROUND	Renin-angiotensin system inhibitors have renoprotective effects in patients with chronic kidney disease , but most patients treated with these drugs have residual urinary albumin excretion .
BACKGROUND	Some small clinical studies show that mineralocorticoid receptor blockade reduces albuminuria .
BACKGROUND	Our study aimed to examine the beneficial effects of addition of a selective aldosterone antagonist , eplerenone , to renin-angiotensin system inhibitors in hypertensive patients with non-diabetic chronic kidney disease .
METHODS	In this double-blind , randomised , placebo-controlled trial , we enrolled hypertensive patients , aged 2079 years , with albuminuria ( urinary albumin-to-creatinine ratio [ UACR ] in the first morning void urine of 30599 mg/g ) , an estimated glomerular filtration rate of 50 mL/min per 173 m2 or more , and who had received an angiotensin-converting enzyme inhibitor , an angiotensin receptor blocker , or both , for at least 8 weeks .
METHODS	Participants were from 59 clinics and hospitals in Japan .
METHODS	Eligible patients were randomly assigned ( 1:1 ) , stratified by baseline characteristics , to either low-dose eplerenone ( 50 mg/day ) or placebo , with continuation of standard antihypertensive treatment to attain therapeutic goals ( < 130/80 mm Hg ) for 52 weeks .
METHODS	We assessed efficacy in all patients who received allocated treatment , provided a baseline and post-treatment urine sample , and remained in follow-up .
METHODS	We assessed safety in all patients who received allocated treatment .
METHODS	The primary efficacy measure was percent change in UACR in the first morning void urine at week 52 from baseline .
METHODS	The trial is registered at the clinical trials registry of University Hospital Medical Information Network ( UMIN ) , trial identification number UMIN000001803 .
RESULTS	Between April 1 , 2009 , and March 31 , 2012 , we randomly allocated 170 patients to the eplerenone group and 166 patients to the placebo group .
RESULTS	In the primary efficacy analysis , mean percent change in UACR from baseline was 173 % ( 95 % CI 3365 to 094 ) for 158 patients in the eplerenone group compared with 103 % ( 675 to 223 ) for 146 patients in the placebo group ( absolute difference 276 % [ 5115 to 396 ] ; p = 00222 ) .
RESULTS	In the safety analyses , 53 ( 31 % ) of 169 patients in the eplerenone group had adverse events ( five serious ) , as did 49 ( 30 % ) of 163 in the placebo group ( seven serious ) .
RESULTS	Although mean serum potassium concentration was higher in the eplerenone group than the placebo group , severe hyperkalaemia ( > 55 mmol/L ) was not recorded in either group .
CONCLUSIONS	Addition of low-dose eplerenone to renin-angiotensin system inhibitors might have renoprotective effects through reduction of albuminuria in hypertensive patients with non-diabetic chronic kidney disease , without serious safety concerns .
BACKGROUND	Pfizer .

###25622774
BACKGROUND	Patients with kidney failure treated with maintenance hemodialysis ( HD ) are poor responders to clopidogrel .
BACKGROUND	More beneficial platelet-inhibiting strategies in HD patients therefore are required .
METHODS	Single-center , prospective , randomized , crossover study .
METHODS	25 HD patients in Seoul , Korea .
METHODS	Patients were randomly assigned to receive clopidogrel ( 300mg loading , 75mg once daily for maintenance dose ) or ticagrelor ( 180mg loading , 90mg twice daily for maintenance dose ) for 14 days , and after a 14-day washout period , crossover treatment for another 14 days .
METHODS	All patients received aspirin ( 100mg/d ) .
METHODS	Platelet function was evaluated predosing and at 1 , 5 , and 48 hours and 14 days after the first loading dose .
METHODS	During the offset phase , platelet function was assessed at 1 hour and 2 , 4 , and 14 days after the last dose by light transmittance aggregometry and the VerifyNow P2Y12 assay , and patients were genotyped for the CYP2C19 * 2 allele .
METHODS	Maximal extent of aggregation , inhibition of platelet aggregation ( IPA ) , P2Y12 reaction units ( PRUs ) , and percentage of inhibition were evaluated .
METHODS	We performed per-protocol analysis , excluding patients who did not complete the protocol .
RESULTS	9 patients did not complete the protocol ( 7 patients due to adverse events ; 2 , nonadherence ) .
RESULTS	Higher IPA occurred with ticagrelor than with clopidogrel at 1 , 5 , and 48 hours and 14 days after loading .
RESULTS	By 5 hours after loading , a greater proportion of patients in the ticagrelor group than in the clopidogrel group achieved IPA > 50 % ( 75 % vs 12 % , respectively ; P < 0.05 ) and IPA > 70 % ( 44 % vs 0 % , respectively ; P < 0.05 ) .
RESULTS	Rates ( slope ) of onset and offset of the antiplatelet effect were faster in patients receiving ticagrelor than for those receiving clopidogrel ( P < 0.05 ) .
RESULTS	Regardless of CYP2C19 * 2 allele , the ticagrelor group had significantly lower PRUs at all times than the clopidogrel group .
CONCLUSIONS	Single-center study with a small number of patients , not a double-blind study , and not intention-to-treat analysis .
CONCLUSIONS	Ticagrelor may result in more rapid and greater platelet inhibition than clopidogrel in patients with kidney failure receiving HD .

###25535193
OBJECTIVE	Nowadays , laparoscopic cholecystectomy ( LC ) is undoubtedly considered the `` gold standard '' in the surgical treatment of symptomatic gallstones , gallbladder adenomas and acute cholecystitis .
OBJECTIVE	Among the alternative energy sources proposed ( monopolar , bipolar electric scalpel , radiofrequency sealers ) with the aim to dissect and/or seal , the ultrasonic energy has been frequently adopted , however without a widespread acceptance among surgeons for routine or emergency laparoscopic cholecystectomy .
OBJECTIVE	This study investigates the possible beneficial aspects of ultrasonic dissection and its efficacy in the closure of the cystic artery and duct .
METHODS	Patients were retrospectively divided into 2 groups according to the instruments used for division of the cystic artery and duct as well as for dissection of the liver bed : 121 patients in whom dissection and coagulation were performed using monopolar coagulation and 43 patients who were all treated with the ultrasonically activated scalpel harmonic ACE ( Ethicon Endo-Surgery ) as the sole instrument used in the whole procedure .
RESULTS	The mean operative time , was significantly shorter in the harmonic group than in the traditional group ( 35.36 + 10.15 min vs. 55.6 +12.10 vs. respectively ; p < 0.0001 ) .
RESULTS	The rate of gallbladder perforation was significantly higher in the traditional group than in the harmonic group 20.66 % ( 25 patients ) vs. 6.98 % ( 3 patients ) , respectively ; p < 0.05 ) .
RESULTS	Intraoperative volume blood loss was significantly more in the traditional group than in the HS group ( 29.32 +14.21 vs. 12.41 +8.22 ; p < 0.0001 ) .
RESULTS	The mean amount of postoperative drainage was not significantly different among the two group ( 18.41 +6.54 vs. 15.96 +8.69 ml , p > 0.05 ) .
RESULTS	No considerable visceral injury has been recorded in either group .
RESULTS	The postoperative parameters observed included postoperative hospital stay and morbidity for each group .
RESULTS	The hospital stay was not significantly shorter in harmonic group ( 48.15 +4.29 vs. 49.06 +2.94 h , p > 0.05 ) .
RESULTS	The overall morbidity rate was 14.02 % ( not significant ) .
CONCLUSIONS	The use of the harmonic scalpel shows some statistically significant advantages limited to a few intraoperative parameters .
CONCLUSIONS	We conclude that a wider use of harmonic scalpel not offers such advantages to make it the reference technique .

###24250291
BACKGROUND	Pulse pressure ( PP ) , might be a stronger determinants of cardiovascular risk .
OBJECTIVE	To investigate the effect of interval training program on PP in subjects with hypertension .
METHODS	Two hundred and forty five male patients with mild to moderate ( Systolic Blood Pressure [ SBP ] between 140-179 & Diastolic Blood Pressure [ DBP ] between 90-109 mmHg ) essential hypertension were age-matched and grouped into exercise and control groups .
METHODS	The exercise ( work : rest ratio of 1:1 ) groups involved in an 8-weeks interval training programs of between 45-60 minutes , at intensities of 60-79 % of HR max ( maximum heart rate ) , while the control group remained sedentary during this period .
METHODS	SBP , DBP , VO2max and PP were assessed .
RESULTS	Findings of the study revealed significant correlation between PP and blood pressure ; correlation of PP with SBP was much stronger ( 95 % variance ) .
RESULTS	Also , there was significant effect of the exercise training program on SBP , DBP and PP .
RESULTS	Changes in VO2max also negatively correlated with changes in PP ( r = -.285 ) at p < 0.05 .
CONCLUSIONS	Moderate intensity interval training programs is effective in the non-pharmacological management of hypertension and may prevent cardiovascular event through the down regulation of PP in hypertension .

###24479279
OBJECTIVE	To evaluate the microleakage of Class II cavities restored with experimental low-shrinking resin composites proposed for bulk filling and to measure their microtensile bond strength ( microTBS ) to dentin and compare to those of previously marketed low-shrinkage composites .
METHODS	Class II cavities ( 7 mm occluso-gingival height , 2 mm mesio-distal depth of the box , 4 mm occlusal depth , 4 mm bucco-lingual width ) were prepared in 50 molars and randomly divided into five groups ( n = 10 ) , according to the material : SureFil SDR flow ( SDR ) , Filtek Silorane ( FS ) and experimental materials ( G-aenial Flo bulk fill , GF ; G-aenial Universal Flo bulk fill , GUF ; GC Kalore bulk fill , GK ) .
METHODS	Microleakage was separately assessed at enamel and dentin margins by scoring the depth of silver-nitrate penetration .
METHODS	Twenty teeth divided into five groups ( n = 4 ) were selected for microTBS testing .
METHODS	The same materials as for microleakage assessment were placed in bulk to mid-coronal dentin .
METHODS	Microtensile beams were loaded in tension , and microTBS at failure was calculated in MPa .
METHODS	Microleakage and microTBS data were analyzed by ANOVA on ranks , followed Dunn 's post hoc test ( P < 0.05 ) .
RESULTS	Microleakage was not observed at the enamel interface in any of the groups .
RESULTS	At the dentin interface , SDR recorded significantly higher microleakage than the other materials .
RESULTS	microTBS of GF , GUF and GK did not differ among each other ( 33 + / - 12 MPa , 31 + / - 11 MPa , 30 + / - 9 MPa , respectively ) , while SDR ( 63 + / - 17 MPa ) and FS ( 55 + / - 17MPa ) achieved significantly higher microTBS values .
RESULTS	No direct association between the sealing properties and the bond strength values was observed .

###25615629
OBJECTIVE	Failure of fusion after a transforaminal lumbar interbody fusion ( TLIF ) procedure is a challenging problem that can lead to ongoing low-back pain , dependence on pain medication , and inability to return to work .
OBJECTIVE	B2A is a synthetic peptide that has proven efficacy in achieving fusion in animal models and may have a better safety profile than bone morphogenetic protein .
OBJECTIVE	The authors undertook this study to evaluate the safety and efficacy of B2A peptide-enhanced ceramic granules ( Prefix ) in comparison with autogenous iliac crest bone graft ( ICBG , control ) in patients undergoing single-level TLIF .
METHODS	Twenty-four patients with single-level degenerative disorders of the lumbar spine at L2-S1 requiring TLIF were enrolled between 2009 and 2010 .
METHODS	They were randomly assigned to 3 groups : a control group ( treated with ICBG , n = 9 ) , a Prefix 150 group ( treated with Prefix 150 g/cm ( 3 ) granules , n = 8 ) , and a Prefix 750 group ( treated with Prefix 750 g/cm ( 3 ) granules , n = 7 ) .
METHODS	Outcome measures included the Oswestry Disability Index ( ODI ) , visual analog pain scale , and radiographic fusion as assessed by CT and dynamic flexion/extension lumbar plain radiographs .
RESULTS	At 12 months after surgery , the radiographic fusion rate was 100 % in the Prefix 750 group , 78 % in the control group , and 50 % in the Prefix 150 group , although the difference was not statistically significant ( p = 0.08 ) .
RESULTS	At 6 weeks the mean ODI score was 41.0 for the control group , 27.7 for the Prefix 750 group , and 32.2 for the Prefix 150 group , whereas at 12 months the mean ODI was 24.4 for control , 31.1 for Prefix 750 , and 29.7 for Prefix 150 groups .
RESULTS	Complications were evenly distributed among the groups .
CONCLUSIONS	Prefix appears to provide a safe alternative to autogenous ICBG .
CONCLUSIONS	Prefix 750 appears to show superior radiographic fusion when compared with autograft at 12 months after TLIF , although no statistically significant difference was demonstrated in this small study .
CONCLUSIONS	Prefix and control groups both appeared to demonstrate comparable improvements to ODI at 12 months .

###24699059
OBJECTIVE	Interventional Management of Stroke ( IMS ) III is a randomized , parallel arm trial comparing the approach of intravenous tissue-type plasminogen activator followed by endovascular treatment with intravenous tissue-type plasminogen activator alone in patients with acute ischemic stroke presenting < 3 hours of symptom onset .
OBJECTIVE	The trial intended to enroll 900 subjects to ensure adequate statistical power to detect an absolute 10 % difference in the percentage of subjects with good outcome , defined as modified Rankin Scale score of 0 to 2 at 3 months .
OBJECTIVE	In April 2012 , after 656 subjects were randomized , further enrollment was terminated by the National Institute of Neurological Disorders and Stroke based on the prespecified criterion for futility using conditional power < 20 % .
METHODS	Conditional power was defined as the likelihood of finding statistical significance at the end of the study , given the accumulated data to date and with the assumption that a minimum hypothesized difference of 10 % truly exists between the 2 groups .
METHODS	The evolution of study data leading to futility determination is described , including the interaction between the unblinded study statisticians and the Data and Safety Monitoring Board in the complex deliberation of analysis results .
RESULTS	The futility boundary was crossed at the trial 's fourth interim analysis .
RESULTS	At this point , based on the conditional power criteria , the Data and Safety Monitoring Board recommended termination of the trial .
CONCLUSIONS	Even in spite of prespecified interim analysis boundaries , interim looks at data pose challenges in interpretation and decision making , underscoring the importance of objective stopping criteria .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00359424 .

###24630536
OBJECTIVE	To develop and validate a scoring system for evaluation of long term anorectal dysfunction following radiotherapy for prostate cancer .
METHODS	Patients treated for prostate cancer with radiotherapy filled in questionnaires on anorectal function and quality of life .
METHODS	Items for the condensed anorectal dysfunction score ( RT-ARD ) were identified and weighted by binomial regression analysis .
METHODS	The score was tested in a separate patient material by receiver operating characteristic ( ROC ) analysis and correlations to quality of life domains .
RESULTS	A total of 309 patients participated in the study .
RESULTS	The items selected were `` incontinence for solid stool '' , `` ability to defer defecation '' , `` unproductive call to stool '' , `` clustering of stool '' , and `` mucus in stool . ''
RESULTS	Patients were grouped into three categories according to the RT-ARD score ; 0-8 ( no RT-ARD ) , 9-23 ( minor RT-ARD ) , 24-45 ( major RT-ARD ) .
RESULTS	ROC analyses revealed high sensitivity ( 91 % ) and specificity ( 85 % ) for major RT-ARD .
RESULTS	The prediction model demonstrated a perfect fit in 60 % , moderate fit in 36 % and no fit in 4 % .
RESULTS	There was good correlation between the RT-ARD score and quality of life .
CONCLUSIONS	The RT-ARD score is a validated and simple instrument for evaluation of anorectal dysfunction following radiotherapy for prostate cancer , and the RT-ARD score correlates to the patient 's quality of life .

###25113389
BACKGROUND	The evaluation of cardiac contraction could benefit from a connection with the underlying helical structure of cardiac fibers in athletes either completely healthy or with minor common cardiopathies like Bicuspid Aortic Valve ( BAV ) .
BACKGROUND	This study aims to exploit the potential role of 3D strain to improve the physiological understanding of LV function and modification due to physical activity as a comparative model .
METHODS	Three age-matched groups of young ( age 20.35.4 ) individuals are prospectively enrolled : 15 normal healthy subjects , 15 healthy athletes , and 20 athletes with bicuspid aortic valve ( BAV ) .
METHODS	All subjects underwent echocardiographic examination and both 2D and 3D strain analysis .
RESULTS	All echo parameters were within the normal range in the three groups .
RESULTS	Global values of end-systolic longitudinal and circumferential strain , assesses by either 2D or 3D analysis , were not significantly different .
RESULTS	The 3D strain analysis was extended in terms of principal and secondary strain ( PS , SS ) .
RESULTS	Global PS was very similar , global SS was significantly higher in athletes and displays a modified time course .
RESULTS	The comparative analysis of strain-lines pattern suggests that the enhancement of LV function is achieved by a more synchronous recruitment of both left - and right-handed helical fibers .
CONCLUSIONS	3D strain analysis allows a deeper physiological understanding of LV contraction in different types of athletes .
CONCLUSIONS	Secondary strain , only available in 3D , identifies increase of performances due to physical activity ; this appears to follow from the synergic activation of endocardial and epicardial fibers .

###24660606
OBJECTIVE	To evaluate the effect on acne vulgaris of pricking-bloodletting cupping at Dazhui ( GV 14 ) under acupuncture anesthesia , and establish whether providing anesthesia to the treatment area by manipulating Hegu ( LI 4 ) and Quchi ( LI 11 ) might have an additional therapeutic benefit .
METHODS	Thirty-eight patients were recruited and randomized into a control group and an intervention group with a single-blind ( observer-blind ) method .
METHODS	The control group was treated by pricking-bloodletting cupping at Dazhui ( GV 14 ) - and the studied group by pricking-bloodletting cupping at Dazhui ( GV 14 ) under acupuncture anesthesia at Hegu ( LI 4 ) and Quchi ( LI 11 ) .
METHODS	Both groups were treated twice weekly for 6 weeks .
METHODS	The analgesic and therapeutic effects of acupuncture were evaluated on a visual analog scale ( VAS ) and global acne grading system ( GAGS ) , respectively .
RESULTS	There were differences in the VAS scores of pain on pricking and in the pricked area , and the duration of pain between the groups .
RESULTS	After 12 treatments , there was a significant reduction in GAGS scores from baseline in both groups , but there was no significant difference between the groups .
CONCLUSIONS	Acupuncture anesthesia at Hegu ( LI 4 ) and Quchi ( LI 11 ) is an effective means of alleviating the pain of pricking-bloodletting cupping and reducing the duration of pain in the treatment area .
CONCLUSIONS	Pricking-bloodletting cupping at Dazhui ( GV 14 ) improves the skin lesions of patients with moderate acne vulgaris , but acupuncture anesthesia does not appear to have an additional therapeutic effect .

###25554757
OBJECTIVE	Screening of immunization status at each health care encounter is recommended to improve immunization coverage rates but is often limited to primary care practices .
OBJECTIVE	A pilot intervention study was performed to ascertain the immunization status of hospitalized children and determine if development of an immunization plan before discharge would improve the vaccination status for such children .
METHODS	On the basis of power calculations estimated to detect an increase in immunization status from 60 % to 70 % with 80 % power , 356 randomly selected children were enrolled between March 6 , 2012 and June 14 , 2012 .
METHODS	Immunization records were obtained , immunization status determined , and parent/guardian informed if catch-up dose ( s ) were needed .
METHODS	If parent requested vaccine dose ( s ) , they were administered before discharge .
RESULTS	Vaccination status was current per Advisory Committee on Immunization Practices guidelines in 73 % of hospitalized children , and 27 % children required catch-up dose ( s ) ( 200 doses for 95 children ) .
RESULTS	Human papilloma virus vaccine ( dose 1 ) , varicella zoster vaccine ( dose 2 ) , and meningococcal conjugate vaccine were the most commonly identified dose ( s ) needed .
RESULTS	Of those requiring catch-up dose ( s ) , 25 % were caught up , increasing vaccination status to 80 % at 1-month post hospital discharge .
CONCLUSIONS	This is the first study to determine the immunization status of hospitalized pediatric patients of all ages , including adolescents , providing new data on the immunization status of the inpatient pediatric population .
CONCLUSIONS	A pilot intervention consisting of obtaining immunization records , determining immunization status , and discussing catch-up dose ( s ) before discharge resulted in improvement of immunization status , suggesting that the inpatient setting may be used along with many other national strategies to help address missed vaccination opportunities .

###24848854
OBJECTIVE	The objective of our study was to conduct a randomized controlled trial of educational interventions that were created to improve performance of screening mammography interpretation .
METHODS	We randomly assigned physicians who interpret mammography to one of three groups : self-paced DVD , live expert-led educational seminar , or control .
METHODS	The DVD and seminar interventions used mammography cases of varying difficulty and provided associated teaching points .
METHODS	Interpretive performance was compared using a pretest-posttest design .
METHODS	Sensitivity , specificity , and positive predictive value ( PPV ) were calculated relative to two outcomes : cancer status and consensus of three experts about recall .
METHODS	The performance measures for each group were compared using logistic regression adjusting for pretest performance .
RESULTS	One hundred two radiologists completed all aspects of the trial .
RESULTS	After adjustment for preintervention performance , the odds of improved sensitivity for correctly identifying a lesion relative to expert recall were 1.34 times higher for DVD participants than for control subjects ( 95 % CI , 1.00-1 .81 ; p = 0.050 ) .
RESULTS	The odds of an improved PPV for correctly identifying a lesion relative to both expert recall ( odds ratio [ OR ] = 1.94 ; 95 % CI , 1.24-3 .05 ; p = 0.004 ) and cancer status ( OR = 1.81 ; 95 % CI , 1.01-3 .23 ; p = 0.045 ) were significantly improved for DVD participants compared with control subjects , with no significant change in specificity .
RESULTS	For the seminar group , specificity was significantly lower than the control group ( OR relative to expert recall = 0.80 ; 95 % CI , 0.64-1 .00 ; p = 0.048 ; OR relative to cancer status = 0.79 ; 95 % CI , 0.65-0 .95 ; p = 0.015 ) .
CONCLUSIONS	In this randomized controlled trial , the DVD educational intervention resulted in a significant improvement in screening mammography interpretive performance on a test set , which could translate into improved interpretative performance in clinical practice .

###25403311
BACKGROUND	Pelubiprofen is a prodrug of 2-arylpropionic acid with relatively selective effects on cyclooxygenase-2 activity .
BACKGROUND	The aim of this study was to compare the efficacy and safety profiles of pelubiprofen with those of celecoxib in patients with rheumatoid arthritis .
METHODS	This was a 6-week , multicenter , randomized , double-blind , double-dummy , parallel-group , phase III , non-inferiority clinical trial .
METHODS	The primary end point was non-inferiority of pain decrease from baseline to week-6 as determined using a 100 mm pain visual analog scale ( VAS ) .
METHODS	Pelubiprofen was considered non-inferior to celecoxib if the lower limit of the 97.5 % confidence interval for treatment difference [ ( pain reduction in pelubiprofen group ) - ( pain reduction in celecoxib group ) ] was more than -10 mm .
METHODS	The secondary end points were as follows : non-inferiority of ( 1 ) reduction of Korean health assessment questionnaire ( KHAQ ) score ; ( 2 ) decreased duration of morning stiffness ; and ( 3 ) decrease in the frequency and total dose of rescue drugs after 6 weeks of treatment .
RESULTS	Seventy-seven patients in the pelubiprofen group and 68 patients in the celecoxib group started the study medication .
RESULTS	Pelubiprofen was non-inferior to celecoxib with regard to reduction in VAS pain severity ( difference , mean SD 5.0 20.1 ; 97.5 % CI , -2.3 to ) .
RESULTS	Pelubiprofen was also non-inferior to celecoxib in terms of the secondary end points , such as , decrease in KHAQ score ( 0.0 0.5 , 97.5 % CI -0.2 to ) , decrease in duration of morning stiffness ( median 0.0 minute in both groups ) , and decrease in the frequency ( 0.7 3.5 , 97.5 % CI -0.6 to ) and total amount ( 0.7 3.6 , 97.5 % CI -0.6 to ) of rescue medication uses during the 6 week study period .
RESULTS	Safety analysis revealed 31.2 % patients in the pelubiprofen group and 20.6 % patients in the celecoxib group experienced an adverse drug reaction ( ADR ) .
RESULTS	The frequency of gastrointestinal ADRs was 20.8 % and 8.8 % , respectively .
CONCLUSIONS	Pelubiprofen was found to be as effective as celecoxib at pain reduction and for relieving stiffness in RA patients .
CONCLUSIONS	However , more patients in the pelubiprofen group experienced ADR and the frequency of gastrointestinal ADRs was higher in the pelubiprofen group .
CONCLUSIONS	ClinialTrials.gov identifier : NCT01781702 .

###24612282
BACKGROUND	Topical corticosteroids ( TC ) consistently show effectiveness against itch , a paradigmatic symptom , in various eczemas .
BACKGROUND	Rapid itch relief is a therapeutic goal .
BACKGROUND	The early response of itch to TC has not been adequately studied .
OBJECTIVE	To assess the effect on itch of a TC , methylprednisolone aceponate 0.1 % ointment ( MPA ) , in induced eczema in volunteers sensitized to nickel sulphate .
METHODS	Sixteen volunteers with a late positive patch-test reaction to nickel sulphate entered the study .
METHODS	Eczema was treated once daily with fingertip unit of MPA for 5days .
METHODS	Pruritus intensity was assessed with a 10cm visual analogue scale ( VAS ) .
METHODS	Mean time to itch relief ( TR ) defined as the time to reach a 30 % decrease in the highest VAS value recorded was assessed , as well as TR-baseline , colorimetry and planimetric morphometry of the reaction .
RESULTS	Mean TR was 1.0 days [ standard deviation ( SD ) = 1.1 ] and mean TR - baseline was 1.6 days ( SD = 1.4 ) .
RESULTS	Five volunteers reached 100 % decrease from itch baseline-VAS in 2.01.2 days , whereas a 75 % decrease was obtained in 1.71.6 days by 16 volunteers .
RESULTS	A clinical improvement of patch-test reaction was apparent at day 11 , although erythema was still present .
CONCLUSIONS	We present a valid model to assess the efficacy and speed of action of TC treatment to alleviate pruritus and the signs of eczema .
CONCLUSIONS	The fast effect of MPA against pruritus supports the appropriateness of treating allergic contact eczema with TC .

###25667293
OBJECTIVE	To assess whether urea-based cream ( UBC ) has prophylactic benefits on sorafenib-induced hand-foot skin reaction ( HFSR ) in patients with advanced hepatocellular carcinoma ( HCC ) .
METHODS	In this randomized , open-label trial , 871 patients with advanced HCC throughout China were treated with 10 % UBC three times per day plus best supportive care ( BSC ; n = 439 ) or BSC alone excluding all creams ( n = 432 ) , starting on day 1 of sorafenib treatment , for up to 12 weeks .
METHODS	HFSR was assessed every 2 weeks and at 14 weeks for patients completing the study .
METHODS	Once HFSR occurred , patients were allowed any cream , including a UBC .
RESULTS	The 12-week incidence of any grade HFSR was significantly lower in the UBC group versus the BSC-alone group ( 56.0 % v 73.6 % , respectively ; odds ratio [ OR ] , 0.457 ; 95 % CI , 0.344 to 0.608 ; P < .001 ) , as was the incidence of grade 2 HFSR ( 20.7 % v 29.2 % , respectively ; OR , 0.635 ; 95 % CI , 0.466 to 0.866 ; P = .004 ) .
RESULTS	Median time to first occurrence of HFSR was significantly longer in the UBC group than the BSC-alone group ( 84 v 34 days , respectively ; hazard ratio , 0.658 ; 95 % CI , 0.541 to 0.799 ; P < .001 ) .
RESULTS	Elevated AST was associated with increased risk of HFSR but did not alter the treatment effect of UBC .
RESULTS	UBC plus BSC , compared with BSC alone , did not affect the sorafenib dose reduction or interruption rate ( 9.1 % v 11.8 % , respectively ; P = .1937 ) , response rate ( 11.1 % v 10.1 % , respectively ; P = .6674 ) , or disease control rate ( 98.8 % v 98.2 % , respectively ; P = .5350 ) at week 12 .
CONCLUSIONS	UBC prophylaxis in patients with advanced HCC starting sorafenib reduced HFSR rates , extended the time to first occurrence of HFSR , and improved patient quality of life compared with BSC .
CONCLUSIONS	Blinded , randomized , placebo-controlled trials to determine the role of UBC on the incidence and severity of HFSR are warranted .

###25425219
OBJECTIVE	Epidemiological studies have found that a diet high in fibre and coffee , but low in red meat , reduces the risk for type 2 diabetes .
OBJECTIVE	We tested the hypothesis that these nutritional modifications differentially improve whole-body insulin sensitivity ( primary outcome ) and secretion .
METHODS	Inclusion criteria were : age 18-69 years , BMI 30 kg/m ( 2 ) , type 2 diabetes treated with diet , metformin or acarbose and known disease duration of 5 years .
METHODS	Exclusion criteria were : HbA1c > 75 mmol/mol ( 9.0 % ) , type 1 or secondary diabetes types and acute or chronic diseases including cancer .
METHODS	Patients taking any medication affecting the immune system or insulin sensitivity , other than metformin , were also excluded .
METHODS	Of 59 patients ( randomised using randomisation blocks [ four or six patients ] with consecutive numbers ) , 37 ( 54 % female ) obese type 2 diabetic patients completed this controlled parallel-group 8-week low-energy dietary intervention .
METHODS	The participants consumed either a diet high in cereal fibre ( whole grain wheat/rye : 30-50 g/day ) and coffee ( 5 cups/day ) , and free of red meat ( L-RISK , n = 17 ) or a diet low in fibre ( 10 g/day ) , coffee-free and high in red meat ( 150 g/day ) diet ( H-RISK , n = 20 ) .
METHODS	Insulin sensitivity and secretion were assessed by hyperinsulinaemic-euglycaemic clamp and intravenous glucose tolerance tests with isotope dilution .
METHODS	Whole-body and organ fat contents were measured by magnetic resonance imaging and spectroscopy .
RESULTS	Whole-body insulin sensitivity increased in both groups ( mean [ 95 % CI ] ) ( H-RISK vs L-RISK : 0.8 [ 0.2 , 1.4 ] vs 1.0 [ 0.4 , 1.7 ] mg kg ( -1 ) min ( -1 ) , p = 0.59 ) , while body weight decreased ( -4.8 % [ -6.1 % , -3.5 % ] vs -4.6 % [ -6.0 % , -3.3 % ] , respectively ) .
RESULTS	Hepatic insulin sensitivity remained unchanged , whereas hepatocellular lipid content fell in both groups ( -7.0 % [ -9.6 % , -4.5 % ] vs -6.7 % [ -9.5 % , -3.9 % ] ) .
RESULTS	Subcutaneous fat mass ( -1,553 [ -2,767 , -340 ] cm ( 3 ) vs -751 [ -2,047 ; 546 ] cm ( 3 ) , respectively ) visceral fat mass ( -206 [ -783 , 371 ] cm ( 3 ) vs -241 [ -856 , 373 ] cm ( 3 ) , respectively ) and muscle fat content ( -0.09 % [ -0.16 % , -0.02 % ] vs -0.02 % [ -0.10 % , 0.05 % ] , respectively ) decreased similarly .
RESULTS	Insulin secretion remained unchanged , while the proinflammatory marker IL-18 decreased only after the L-RISK diet .
CONCLUSIONS	No evidence of a difference between both low-energy diets was identified .
CONCLUSIONS	Thus , energy restriction per se seems to be key for improving insulin action in phases of active weight loss in obese type 2 diabetic patients , with a potential improvement of subclinical inflammation with the L-RISK diet .
BACKGROUND	Clinicaltrials.gov NCT01409330 .
BACKGROUND	This study was supported by the Ministry of Science and Research of the State of North Rhine-Westphalia ( MIWF NRW ) , the German Federal Ministry of Health ( BMG ) , the Federal Ministry for Research ( BMBF ) to the Center for Diabetes Research ( DZD e.V. ) and the Helmholtz Alliance Imaging and Curing Environmental Metabolic Diseases ( ICEMED ) .

###25539648
BACKGROUND	Safety of tenofovir disoproxil fumarate/emtricitabine ( TDF-FTC ) has been studied more extensively among HIV-infected patients than among HIV-uninfected people .
BACKGROUND	Using data from a pre-exposure trial - FEM-PrEP - , we determined the cumulative probabilities of grade 1 + ALT , AST and creatinine and grade 2 + phosphorus toxicities ; ALT/AST toxicities by baseline hepatitis B status ; and change in mean creatinine , phosphorus , ALT and AST levels controlling for TDF-FTC adherence .
RESULTS	FEM-PrEP was a randomized , blinded , placebo-controlled trial of daily TDF-FTC among women in Africa .
RESULTS	Enrolled women were in general good health , HIV antibody negative , 18 to 35 years old , hepatitis B surface antigen negative , and had normal hepatic and renal function at baseline .
RESULTS	AST , ALT , phosphorus and serum creatinine were measured regularly throughout the trial .
RESULTS	TDF-FTC concentrations were measured to assess adherence to TDF-FTC .
RESULTS	The cumulative probabilities of grade 1 + creatininemia and grade 2 + phosphatemia toxicities were not statistically different between TDF-FTC and placebo arms .
RESULTS	The cumulative probabilities of grade 1 + ALT and AST toxicities were higher among participants in the TDF-FTC arm than in the placebo arm ( p = 0.03 for both ) .
RESULTS	The proportions of grade 1 + and grade 2 + ALT or AST toxicities were significantly higher in participants who were hepatitis B virus surface antibody ( HBsAb ) positive than in those who were HBsAb-negative .
RESULTS	Women with good adherence had higher mean change from baseline to week 4 in their AST levels ( 2.90 ( 0.37 , 5.42 ) ; p = 0.025 ) than women with less than good adherence .
CONCLUSIONS	We did not observe a significant relationship between randomization to TDF-FTC and creatinine or phosphorus toxicities .
CONCLUSIONS	Women randomized to TDF-FTC had higher rates of mild to moderate ALT/AST toxicities , especially women with prior hepatitis B virus exposure .
CONCLUSIONS	We also observed a significant increase in AST from baseline to week 4 among women who had higher adherence to TDF-FTC during that interval .
BACKGROUND	#NCT 00625404 , February 19 , 2008 .

###25015174
OBJECTIVE	This study implemented pharmacokinetic/pharmacodynamic modelling to support the clinical development of RBP-6000 , a new , long-acting , sustained-release formulation of buprenorphine for the treatment of opioid dependence .
OBJECTIVE	Such a formulation could offer advantages over existing buprenorphine pharmacotherapy by improving patient compliance and reducing the diversion of the product .
METHODS	A population pharmacokinetic model was developed using 36 opioid-dependent subjects who received single subcutaneous doses of RBP-6000 .
METHODS	Another pharmacokinetic/pharmacodynamic model was developed using - opioid receptor occupancy ( ORO ) data to predict efficacy of RBP-6000 after repeated doses .
METHODS	It was also assessed how buprenorphine plasma concentrations were correlated with opioid withdrawal symptoms and hydromorphone agonist blockade data from 15 heroin-dependent subjects .
RESULTS	The resulting pharmacokinetic model accurately described buprenorphine and norbuprenorphine plasma concentrations .
RESULTS	A saturable maximum effect ( E max ) model with 0.67 ng/mL effective concentration at 50 % of maximum ( EC50 ) and 91 % E max best described ORO versus buprenorphine plasma concentrations .
RESULTS	Linear relationships were found among ORO , withdrawal symptoms and blockade of agonist effects .
CONCLUSIONS	Previously published findings have demonstrated ORO 70 % is needed to achieve withdrawal suppression and blockade of opioid agonist subjective effects .
CONCLUSIONS	Model simulations indicated that a 200 mg RBP-6000 dose should achieve 23 ng/mL buprenorphine average concentrations and desired efficacy .

###24309401
OBJECTIVE	The aim of this study was to investigate the effects of the vasodilating - blocker nebivolol and the cardioselective - blocker metoprolol on nitric oxide ( NO ) levels at vascular graft endothelium and vasa vasorum compared to controls in patients undergoing coronary artery bypass graft surgery .
METHODS	This was a prospective study .
METHODS	Fifty-five patients were divided into three groups : nebivolol group ( group N , n = 23 ) , metoprolol group ( group M , n = 16 ) , and control group ( group A , n = 16 ) .
METHODS	Group N received nebivolol 5 mg once daily , and group M received metoprolol 50 mg once daily for 15 days in the preoperative period .
METHODS	Control patients did not use - blocker therapy .
METHODS	Tissue samples of both left internal mammary artery ( LIMA ) and saphenous vein grafts were investigated for NO activity using immunohistochemical methods .
RESULTS	Demographic characteristics and risk factors were similar between groups .
RESULTS	We observed the highest NO activity in group N in both endothelial and vasa vasorum samples of LIMA and saphenous veins .
RESULTS	NO activity of metoprolol group was similar to controls .
CONCLUSIONS	According to our results , we think that nebivolol may be safer and preferable in order to diminish graft spasm in patients undergoing coronary artery bypass graft surgery due to the NO-mediated vasodilating effect .

###24882606
OBJECTIVE	To evaluate the effectiveness of subcostal TAP block and to compare its efficacy with that of posterior TAP block in decreasing postoperative pain in patients undergoing laparoscopic cholecystectomy during general anesthesia .
METHODS	Prospective , randomized , double-blind study .
METHODS	Academic medical center .
METHODS	60 adult , ASA physical status 1 and 2 patients of both genders , aged 18-60 years , scheduled for elective laparoscopic cholecystectomy .
METHODS	Patients were randomized to three groups of 20 patients each .
METHODS	Group 1 patients received standard general anesthesia ( control group ) ; Group 2 patients received an ultrasound-guided posterior TAP block using 15 mL of 0.375 % ropivacaine on each side ; and Group 3 patients underwent a subcostal TAP block with 15 mL of 0.375 % ropivacaine on each side .
METHODS	The presence and severity of pain during rest and movement , as well as nausea or vomiting and sedation , were assessed in all patients postoperatively on PACU admission , then at 2 , 4 , 6 , 8 , 12 , and 24-hour intervals .
METHODS	Patients with a visual analog score ( VAS ) greater than 4 , or those requesting analgesic were given intravenous tramadol 2 mg/kg as an initial dose ; subsequent 1 mg/kg doses of tramadol , if needed , were given .
RESULTS	Patients who received a subcostal TAP block had significantly lower pain scores at rest and on movement than the control group at all times postoperatively .
RESULTS	Although , in the initial postoperative measurement times , the subcostal and posterior TAP groups had comparable pain scores , after 4 hours these scores were significantly lower in patients who had received the subcostal TAP block .
CONCLUSIONS	For incisions mainly involving the supra-umbilical region , subcostal TAP block may be a better alternative than the posterior approach for providing postoperative analgesia .

###25710755
OBJECTIVE	To evaluate pharmacokinetics , recovery times , and recovery quality in horses anesthetized with 1.2 times the minimum alveolar concentration of sevoflurane or desflurane .
METHODS	6 healthy adult horses .
METHODS	Anesthesia was maintained with sevoflurane or desflurane for 2 hours at 1.2 times the minimum alveolar concentration .
METHODS	Horses recovered without assistance .
METHODS	During recovery , end-tidal gas samples were collected until horses spontaneously moved .
METHODS	Anesthetic concentrations were measured by use of gas chromatography .
METHODS	After a 1-week washout period , horses were anesthetized with the other inhalation agent .
METHODS	Video recordings of anesthetic recovery were evaluated for recovery quality on the basis of a visual analogue scale by investigators who were unaware of the anesthetic administered .
METHODS	Anesthetic washout curves were fit to a 2-compartment kinetic model with multivariate nonlinear regression .
METHODS	Normally distributed interval data were analyzed by means of paired Student t tests ; ordinal or nonnormally distributed data were analyzed by means of Wilcoxon signed rank tests .
RESULTS	Horses recovered from both anesthetics without major injuries .
RESULTS	Results for subjective recovery evaluations did not differ between anesthetics .
RESULTS	Area under the elimination curve was significantly smaller and time to standing recovery was significantly less for desflurane than for sevoflurane , although distribution and elimination constants did not differ significantly between anesthetics .
CONCLUSIONS	Differences in area under elimination the curve between anesthetics indicated more rapid clearance for desflurane than for sevoflurane in horses , as predicted by anesthetic blood solubility differences in this species .
CONCLUSIONS	More rapid elimination kinetics was associated with faster recovery times , but no association with improved subjective recovery quality was detected .

###24460668
BACKGROUND	CLP is an orally administered , non-absorbed , superabsorbent polymer being developed to increase fecal excretion of sodium , potassium and water in patients with heart failure and end-stage renal disease .
BACKGROUND	This study was conducted to evaluate the safety of CLP , and to explore dose-related effects on fecal weight , fecal and urine sodium and potassium excretion , and serum electrolyte concentrations .
METHODS	This Phase 1 , open-label , dose-escalation study included 25 healthy volunteers , who were administered CLP orally immediately prior to four daily meals for 9 days at doses of 7.5 , 15.0 , and 25.0 g/day ( n = 5/group ) .
METHODS	An additional dose group received 15.0 g/day CLP under fasting conditions , and an untreated cohort ( n = 5 ) served as control .
METHODS	Twenty-four-hour fecal and urinary output was collected daily .
METHODS	Samples were weighed , and sodium , potassium , and other ion content in stool and urine were measured for each treatment group .
METHODS	Effects on serum cation concentrations , other standard laboratory values , and adverse events were also determined .
RESULTS	At doses below 25.0 g/day , CLP was well tolerated , with a low frequency of self-limiting gastrointestinal adverse events .
RESULTS	CLP increased fecal weight and fecal sodium and potassium content in a dose-related manner .
RESULTS	Concomitant dose-related decreases in urinary sodium and potassium were observed .
RESULTS	All serum ion concentrations remained within normal limits .
CONCLUSIONS	In this study , oral CLP removed water , sodium and potassium from the body via the gastrointestinal tract in a dose related fashion .
CONCLUSIONS	CLP could become useful for patients with fluid overload and compromised kidney function in conditions such as congestive heart failure , salt sensitive hypertension , chronic kidney disease and end stage renal disease .
BACKGROUND	NCT01944007 .

###25066223
BACKGROUND	Metacognitive training ( MCT ) for patients with psychosis is a psychological group intervention that aims to educate patients about common cognitive biases underlying delusion formation and maintenance , and to highlight their negative consequences in daily functioning .
METHODS	In this randomized controlled trial , 154 schizophrenia spectrum patients with delusions were randomly assigned to either MCT + treatment as usual ( TAU ) or TAU alone .
METHODS	Both groups were assessed at baseline , and again after 8 and 24 weeks .
METHODS	The trial was completed fully by 111 patients .
METHODS	Efficacy was measured with the Psychotic Symptom Rating Scales ( PSYRATS ) Delusions Rating Scale ( DRS ) , and with specific secondary measures referring to persecutory ideas and ideas of social reference ( the Green Paranoid Thoughts Scale , GPTS ) , cognitive insight ( the Beck Cognitive Insight Scale , BCIS ) , subjective experiences of cognitive biases ( the Davos Assessment of Cognitive Biases Scale , DACOBS ) and metacognitive beliefs ( the 30-item Metacognitions Questionnaire , MCQ-30 ) .
METHODS	Economic analysis focused on the balance between societal costs and health outcomes ( quality-adjusted life years , QALYs ) .
RESULTS	Both conditions showed a decrease of delusions .
RESULTS	MCT was not more efficacious in terms of reducing delusions , nor did it change subjective paranoid thinking and ideas of social reference , cognitive insight or subjective experience of cognitive biases and metacognitive beliefs .
RESULTS	The results of the economic analysis were not in favour of MCT+TAU .
CONCLUSIONS	In the present study , MCT did not affect delusion scores and self-reported cognitive insight , or subjective experience of cognitive biases and metacognitive beliefs .
CONCLUSIONS	MCT was not cost-effective .

###24640436
OBJECTIVE	To investigate the applicability of flowable composites as post luting agents by assessing the push-out strength of posts .
METHODS	36 intact single rooted human premolars were selected .
METHODS	The endodontic treatment was performed and half of the specimens were restored with light transmitting posts ( DT Light Post Illusion ) and the other half with opaque posts ( Tech 21 X-OP ) .
METHODS	In both groups the following combinations of adhesive/cement were tested : OptiBond Solo Plus/Nexus Third Generation ( NX3 ) , XP Bond/SureFil SDR Flow ( SDR ) , and Vertise Flow ( VF ) .
METHODS	Push-out test was used to assess the retentive strength of fiber posts , which was expressed in megapascals ( MPa ) .
METHODS	Specimens were analyzed under a stereomicroscope to determine failure mode ( adhesive between luting agent and post , adhesive between luting agent and dentin or mixed failure ) .
METHODS	Push-out data and failure mode distribution were analyzed by two-way ANOVA and Chi-square test , respectively ( P < 0.05 ) .
RESULTS	The statistical analysis revealed that only the type of luting material significantly influenced push-out bond strength of the post ( P < 0.001 ) .
RESULTS	SDR ( 9.00 + / - 2.17 MPa ) performed similarly to the control group NX3 ( 7.15 + / - 1.74 MPa ) , while VF ( 4.81 + / - 1.51 MPa ) should significantly lower bond strength .
RESULTS	Failure modes differed significantly among groups .

###24861828
OBJECTIVE	Estrogen therapy is the gold standard treatment for hot flashes and night sweats , but some women are unable or unwilling to use it because of associated risks .
OBJECTIVE	The serotonin-norepinephrine reuptake inhibitor venlafaxine hydrochloride is used widely as a nonhormonal treatment .
OBJECTIVE	While the clinical impression is that serotonin-norepinephrine reuptake inhibitors are less effective than estrogen , these medications have not been simultaneously evaluated in one clinical trial to date .
OBJECTIVE	To determine the efficacy and tolerability of low-dose oral 17-estradiol and low-dose venlafaxine extended release in alleviating vasomotor symptoms ( VMS ) .
METHODS	In total , 339 perimenopausal and postmenopausal women with at least 2 bothersome VMS per day ( mean , 8.1 per day ) were recruited from the community to MsFLASH ( Menopause Strategies : Finding Lasting Answers for Symptoms and Health ) clinical network sites between December 5 , 2011 , and October 15 , 2012 .
METHODS	Participants were randomized to double-blind treatment with low-dose oral 17-estradiol ( 0.5 mg/d ) ( n = 97 ) , low-dose venlafaxine hydrochloride extended release ( 75 mg/d ) ( n = 96 ) , or placebo ( n = 146 ) for 8 weeks .
METHODS	The primary outcome was the mean daily frequency of VMS after 8 weeks of treatment .
METHODS	Secondary outcomes were VMS severity , bother , and interference with daily life .
METHODS	Intent-to-treat analyses compared the change in VMS frequency between each active intervention and placebo and between the 2 active treatments .
RESULTS	Compared with baseline , the mean VMS frequency at week 8 decreased to 3.9 ( 95 % CI , 2.9-4 .9 ) VMS per day ( 52.9 % reduction ) in the estradiol group , to 4.4 ( 95 % CI , 3.5-5 .3 ) VMS per day ( 47.6 % reduction ) in the venlafaxine group , and to 5.5 ( 95 % CI , 4.7-6 .3 ) VMS per day ( 28.6 % reduction ) in the placebo group .
RESULTS	Estradiol reduced the frequency of symptoms by 2.3 more per day than placebo ( P < .001 ) , and venlafaxine reduced the frequency of symptoms by 1.8 more per day than placebo ( P = .005 ) .
RESULTS	The results were consistent for VMS severity , bother , and interference .
RESULTS	Low-dose estradiol reduced the frequency of symptoms by 0.6 more per day than venlafaxine ( P = .09 ) .
RESULTS	Treatment satisfaction was highest ( 70.3 % ) for estradiol ( P < .001 vs placebo ) , lowest ( 38.4 % ) for placebo , and intermediate ( 51.1 % ) for venlafaxine ( P = .06 vs placebo ) .
RESULTS	Both interventions were well tolerated .
CONCLUSIONS	Low-dose oral estradiol and venlafaxine are effective treatments for VMS in women during midlife .
CONCLUSIONS	While the efficacy of low-dose estradiol may be slightly superior to that of venlafaxine , the difference is small and of uncertain clinical relevance .
BACKGROUND	clinicaltrials.gov Identifier : NCT01418209 .

###24525553
OBJECTIVE	Alternative forms of cardiac resynchronization therapy ( CRT ) , including biventricular endocardial ( BV-Endo ) and multisite epicardial pacing ( MSP ) , have been developed to improve response .
OBJECTIVE	It is unclear which form of stimulation is optimal .
OBJECTIVE	We aimed to compare the acute haemodynamic response ( AHR ) and electrophysiological effects of BV-Endo with MSP via two separate coronary sinus ( CS ) leads or a single-quadripolar CS lead .
RESULTS	Fifteen patients with a previously implanted CRT system received a second temporary CS lead and left ventricular ( LV ) endocardial catheter .
RESULTS	A pressure wire and non-contact mapping array were placed into the LV cavity to measure LVdP/dtmax and perform electroanatomical mapping .
RESULTS	Conventional CRT , BV-Endo , and MSP were then performed ( MSP-1 via two epicardial leads and MSP-2 via a single-quadripolar lead ) .
RESULTS	The best overall AHR was found using BV-Endo pacing with a 19.6 13.6 % increase in AHR at the optimal endocardial site over baseline ( P < 0.001 ) .
RESULTS	There was an increase in LVdP/dtmax with MSP-1 and MSP-2 compared with conventional CRT , but this was not statistically significant .
RESULTS	Biventricular endocardial pacing from the optimal site was significantly superior to conventional CRT ( P = 0.039 ) .
RESULTS	The AHR achieved when BV-Endo pacing was highly site specific .
RESULTS	Within individuals , the best pacing modality varied and was affected by the underlying substrate .
RESULTS	Left ventricular activation times did not predict the optimal haemodynamic configuration .
CONCLUSIONS	Biventricular endocardial pacing and not MSP was superior to conventional CRT , but was highly site specific .
CONCLUSIONS	Within individuals , however , different methods of stimulation are optimal and may need to be tailored to the underlying substrate .

###25335250
OBJECTIVE	To compare the efficacy difference among acupuncture smoothing-liver and regulating-spleen method , regulating Governor Vessel method and oral administration of western medicine for menopausal insomnia .
METHODS	One hundred and fifty-six cases of menopausal insomnia were randomized into a smoothing-liver and regulating-spleen group ( group A ) , a regulating Governor Vessel group ( group B ) and a medication group ( group C ) , 52 cases in each one .
METHODS	Acupuncture at Zhongwan ( CV 12 ) , Daheng ( SP 15 ) , Sanyinjiao ( SP 6 ) and Taichong ( LR 3 ) , etc. was applied in the group A ; acupuncture at Baihui ( GV 20 ) , Fengfu ( GV 16 ) , Shenting ( GV 24 ) and Yintang ( GV 29 ) , etc. was used in the group B ; oral administration of estazolam tablets ( 1 mg each-day ) was adapted in the group C , all once a day for totally 30 days .
METHODS	The each item score and total score in Pittsburgh sleep quality index ( PSQI ) were evaluated before and after treatment in each group , also the efficacy in each group was assessed .
RESULTS	After the treatment , the sleeping rate in the group A and B was significantly higher than that in the group C ( both P < 0.05 ) ; the total effective rate in the Group A and B was also significantly higher than that in the group C [ 86.5 % ( 45/52 ) and 82.7 % ( 43/52 ) vs 63.5 % ( 33/52 ) , both P < 0.05 ; the total cured rate in the group A was significantly higher than those in the group B and C [ 48.1 % ( 25/52 ) vs 23.1 % ( 12/52 ) and 25.0 % ( 13/52 ) , both P < 0.05 ] .
RESULTS	Each item score and total score of PSQI were all improved after treatment in the group A and B ( P < 0.01 , P < 0.05 ) , while only sleeping time , sleeping efficiency and total score were improved in the group C ( all P < 0.05 ) .
RESULTS	The sleeping quality , sleeping time , sleeping difficulty and daytime dysfunction in the group A were all lower than those in the group C ( all P < 0.05 ) .
RESULTS	The sleeping quality , sleeping time and daytime dysfunction in the goup B were all lower than those in the group C ( all P < 0.05 ) .
RESULTS	The total score in the group A was significantly lower than that in the group B and C ( both P < 05 ) .
CONCLUSIONS	Acupuncture has better effect for menopausal insomnia than estazolam .
CONCLUSIONS	Between the two acupuncture methods , the acupuncture method of smoothing-liver and regulating-spleen has a better effect .

###24252583
BACKGROUND	The aim of the present study was to evaluate the acute effects of resistance exercise ( RE ) leading to failure and RE that was not to failure on 24 h blood pressure ( BP ) and heart rate variability ( HRV ) in sedentary normotensive adult women .
METHODS	Ten women ( 33.2 5.8 years ; 159.3 9.4 cm ; 58.0 6.4 kg ; body fat 28.4 2.8 % ) randomly underwent three experimental sessions : control ( 40 minutes of seated rest ) , RE leading to failure with 3 sets of 10 repetitions maximum ( 10-RM ) , and RE not to failure at 60 % of 10-RM with 3 sets of 10 repetitions .
METHODS	Immediately post session BP and HRV were measured for 24 h.
RESULTS	Ratings of perceived exertion and heart rate were higher during the 10-RM session when compared with 60 % of 10-RM ( 6.4 0.5 vs 3.5 0.8 and 123.7 13.9 vs 104.5 7.3 bpm , respectively ) .
RESULTS	The systolic , diastolic and mean BP decreased at 07:00 a.m. after the 10-RM session when compared with the control session ( -9.0 7.8 mmHg , -16.0 12.9 mmHg and -14.3 11.2 mmHg , respectively ) .
RESULTS	The root mean square of the squared differences between R-R intervals decreased after both the 60 % of 10-RM and 10-RM sessions compared with the control session .
CONCLUSIONS	An acute RE session leading to failure induced a higher drop of BP upon awakening , while both RE sessions reduced cardiac parasympathetic modulation .
CONCLUSIONS	RE may be an interesting training strategy to acutely decrease BP in adult women .

###26281326
OBJECTIVE	Noninvasive mechanical ventilation ( NIMV ) is an approach to prevent complications in acute respiratory failure .
OBJECTIVE	In this study we aimed to compare the efficacy of a full face mask and a helmet in chronic obstructive pulmonary disease ( COPD ) .
METHODS	Fifty patients were divided randomly into 2 groups as full face mask ( Group F ) and helmet ( Group H ) .
METHODS	Demographic data , forced expiratory volume at 1 s ( FEV1 ) , additional disease , hemodynamic parameters , respiratory rate , APACHE II score , peripheral O2 saturation ( SpO2 ) , arterial blood gases ( ABG ) , patient tolerance scale ( PTS ) score , and fraction of inspired oxygen ( FiG2 ) were recorded .
METHODS	Parameters were recorded as follows : 20 min before the NIMV ; every 30 min of NIMV until 120 min ; 30 min , 24 h , and 48 h after NIMV ; and prior to intensive care unit discharge .
RESULTS	The SpO2 , PTS , ABG , complication rate , and APACHE II scores were not different between the groups ( P > 0.05 ) .
RESULTS	The decrease in PaCO2 was statistically significant at 60 min in Group F ( P < 0.05 ) , and there was no statistical difference in Group H ( P < 0.05 ) according to initial PaCO2 values .
CONCLUSIONS	Both masks are efficient in improving the patients ' outcome in COPD , but the decrease in PaCO2in the helmet group was slower than in the full face mask group .

###25439772
OBJECTIVE	Small early postoperative hemodynamic differences were noted in a randomized comparison of 3 current-generation bioprosthetic aortic valves .
OBJECTIVE	Whether these differences persist and influence clinical outcomes 1 year following implantation is unknown .
METHODS	Three hundred adults with severe aortic stenosis undergoing valve replacement were randomized to receive the Epic ( St Jude , St Paul , Minn ) ( n = 99 ) , Magna ( Edwards LifeSciences Inc , Irvine , Calif ) ( n = 100 ) , or Mitroflow ( Sorin Biomedica Spa , Saluggio , Italy ) ( n = 101 ) bioprostheses .
METHODS	Hemodynamic valve performance was examined by echocardiography at 1 year , and clinical outcomes were assessed in 241 patients ( 79 Epic , 77 Magna , and 85 Mitroflow ; P = .437 ) .
RESULTS	Mean age was 75 8 years and 164 were men ( 68 % ) .
RESULTS	Between dismissal and 1 year there were 9 deaths ( 3.7 % ) ( Epic : 3.7 % , Magna : 5.0 % , and Mitroflow : 2.3 % ; P = .654 ) , 6 episodes of heart failure ( 2.5 % ) ( Epic :1.3 % , Magna : 1.3 % , and Mitroflow : 5.8 % ; P = .265 ) , 27 instances of atrial fibrillation/flutter ( 11.2 % ) ( Epic : 8.1 % , Magna : 11.0 % , and Mitroflow : 7.9 % ; P = .577 ) and no strokes/transient ischemic attacks .
RESULTS	One-year echocardiography demonstrated small hemodynamic differences between Epic , Magna , and Mitroflow bioprostheses in mean gradient ( 15.2 5.5 , 12.3 4.3 , and 16.2 5.7 mm Hg , respectively ; P < .001 ) and indexed aortic valve area ( 0.93 0.28 , 1.04 0.28 , and 0.96 -0.26 cm ( 2 ) / m ( 2 ) , respectively ; P = .015 ) .
RESULTS	Several early trends persisted when stratifying data by echocardiographic annulus diameter , universal annulus size , and implant size , particularly with annular size 23 mm .
RESULTS	Overall left ventricular mass index regression between dismissal and 1 year was -16.5 28.1 g/m ( 2 ) , and was similar among groups ( P = .262 ) .
RESULTS	There were no aortic valve reoperations .
CONCLUSIONS	Despite midterm persistence of small hemodynamic differences amongst current-generation porcine and pericardial aortic valves , our prospective randomized comparison reveals that clinical outcomes and mass regression are equivalent between devices at 1 year .
CONCLUSIONS	These encouraging trends must continue to be assessed during longitudinal follow-up .

###24806836
OBJECTIVE	A randomized crossover trial was designed to analyze the impact of a short-term , isoenergetic fat-rich or carbohydrate ( CHO ) - rich diet on substrate oxidation rates during submaximal exercise and on performance in a 10,000-m running time trial in trained , mid - to late-pubertal boys .
METHODS	An incremental test was performed to determine the peak oxygen uptake ( VO2peak ) .
METHODS	After 2 days on a fat-rich ( 24.2 % 0.8 % CHO , 60.4 % 0.3 % fat , and 15.5 % 1.0 % protein ) , CHO-rich ( 69.3 % 1.2 % CHO , 15.9 % 2.1 % fat , and 15.1 % 1.1 % protein ) , or habitual ( 56.1 % 7.0 % CHO , 27.5 % 4.9 % fat , and 16.5 % 4.0 % protein ) diet , 19 trained adolescent boys ( 15.21.5 years ) performed a 10-minute constant run at 65 % VO2peak to determine the respiratory exchange ratio ( RER ) during exercise and 10,000-m running on an outdoor track .
RESULTS	During the constant run , the RER and CHO contribution to energy expenditure were lower , and fat contribution higher , in the fat-rich diet than in the CHO-rich diet ( P < 0.05 ) , but the results were not different from those of the habitual diet .
RESULTS	Performance in the 10,000-m run after consuming CHO - and fat-rich diets was similar to performance after a habitual diet ( 50.07.0 , 51.98.3 , and 50.97.4 minutes , respectively ) , but consuming a CHO-rich diet enhanced performance compared with that after a fat-rich diet ( P = 0.03 ) .
CONCLUSIONS	These findings indicate that a CHO-rich diet provides additional benefits to 10,000-m running performance in trained adolescent boys compared with a fat-rich diet .

###24239881
OBJECTIVE	To assess the efficacy of inhibitory repetitive transcranial magnetic stimulation ( rTMS ) for decreasing upper-limb muscle tone after chronic stroke .
METHODS	A randomized sham-controlled trial with a 4-week follow-up .
METHODS	Research hospital .
METHODS	Patients with stroke ( N = 20 ) with poststroke upper limb spasticity .
METHODS	The experimental group received rTMS to the primary motor cortex of the unaffected side ( 1500 pulses ; 1Hz ; 90 % of resting motor threshold for the first dorsal interosseous muscle ) in 10 sessions , 3d/wk , and physical therapy ( PT ) .
METHODS	The control group received sham stimulation and PT .
METHODS	Modified Ashworth scale ( MAS ) , upper-extremity Fugl-Meyer assessment , FIM , range of motion , and stroke-specific quality-of-life scale .
METHODS	All outcomes were measured at baseline , after treatment ( postintervention ) , and at a 4-week follow-up .
METHODS	A clinically important difference was defined as a reduction of 1 in the MAS score .
RESULTS	Friedman test revealed that PT is efficient for significantly reducing the upper limb spasticity of patients only when it is associated with rTMS .
RESULTS	In the experimental group , 90 % of the patients at postintervention and 55.5 % at follow-up showed a decrease of 1 in the MAS score , representing clinically important differences .
RESULTS	In the control group , 30 % of the patients at postintervention and 22.2 % at follow-up experienced clinically meaningful changes .
RESULTS	There were no differences between the groups at any time for any of the other outcome measures , indicating that both groups demonstrated similar behaviors over time for all variables .
CONCLUSIONS	rTMS associated with PT can be beneficial in reducing poststroke spasticity .
CONCLUSIONS	However , more studies are needed to clarify the clinical changes underlying the reduction in spasticity induced by noninvasive brain stimulations .

###24664177
OBJECTIVE	Odors are powerful emotional stimuli influencing mood , attention and behavior .
OBJECTIVE	Here we examined if odors change the perception of pleasant touch .
OBJECTIVE	In line with the warning function of the olfactory system , we proposed that especially unpleasant odors will reduce touch pleasantness , presumably through a disgust-related mechanism .
METHODS	Forty-five healthy participants ( mean age 23.3 + / - 3years SD , 24 females ) were presented to slow ( 3 cm/s ) and fast ( 30 cm/s ) brush stroking delivered by a robot to the forearm .
METHODS	Touch pleasantness under the influence of an unpleasant odor ( Civette , smelling like feces ) and an intensity matched pleasant odor ( Rose ) was compared to an odorless control condition .
METHODS	In a pilot study with 30 participants ( mean age 25.9 + / -6 years , 21 females ) , the odors were matched according to their intensity , and we studied the influence of disgust sensitivity on the perception of 4 different odor qualities .
RESULTS	The unpleasant odor decreased touch pleasantness for both stroking velocities compared to the odorless control ( p < 0.005 ) whereas the rose odor did not change touch pleasantness significantly .
RESULTS	Disgust sensitivity was correlated with the modulation of touch pleasantness .
RESULTS	The pilot study revealed a significant correlation between disgust sensitivity and the perception of the unpleasant odor qualities ( r = -0.56 ; p = 0.007 ) , but not with any of the other odors .
CONCLUSIONS	Unpleasant odors are powerful in modulating touch pleasantness , and disgust might be a moderating variable .

###24693891
BACKGROUND	Congenital infection with human cytomegalovirus ( CMV ) is a major cause of morbidity and mortality .
BACKGROUND	In an uncontrolled study published in 2005 , administration of CMV-specific hyperimmune globulin to pregnant women with primary CMV infection significantly reduced the rate of intrauterine transmission , from 40 % to 16 % .
METHODS	We evaluated the efficacy of hyperimmune globulin in a phase 2 , randomized , placebo-controlled , double-blind study .
METHODS	A total of 124 pregnant women with primary CMV infection at 5 to 26 weeks of gestation were randomly assigned within 6 weeks after the presumed onset of infection to receive hyperimmune globulin or placebo every 4 weeks until 36 weeks of gestation or until detection of CMV in amniotic fluid .
METHODS	The primary end point was congenital infection diagnosed at birth or by means of amniocentesis .
RESULTS	A total of 123 women could be evaluated in the efficacy analysis ( 1 woman in the placebo group withdrew ) .
RESULTS	The rate of congenital infection was 30 % ( 18 fetuses or infants of 61 women ) in the hyperimmune globulin group and 44 % ( 27 fetuses or infants of 62 women ) in the placebo group ( a difference of 14 percentage points ; 95 % confidence interval , -3 to 31 ; P = 0.13 ) .
RESULTS	There was no significant difference between the two groups or , within each group , between the women who transmitted the virus and those who did not , with respect to levels of virus-specific antibodies , T-cell-mediated immune response , or viral DNA in the blood .
RESULTS	The clinical outcome of congenital infection at birth was similar in the two groups .
RESULTS	The number of obstetrical adverse events was higher in the hyperimmune globulin group than in the placebo group ( 13 % vs. 2 % ) .
CONCLUSIONS	In this study involving 123 women who could be evaluated , treatment with hyperimmune globulin did not significantly modify the course of primary CMV infection during pregnancy .
CONCLUSIONS	( Funded by Agenzia Italiana del Farmaco ; CHIP ClinicalTrials.gov number , NCT00881517 ; EudraCT no. 2008-006560-11 . )

###24876164
BACKGROUND	Photodynamic therapy ( PDT ) using 5-aminolevulinic acid ( ALA ) with red light is well established for actinic keratosis ( AK ) .
BACKGROUND	Differences have been observed concerning pain and efficacy rates with different red light sources .
OBJECTIVE	To compare pain scores , short - and long-term efficacy rates of PDT of multiple AKs when employing different red light sources .
METHODS	In a controlled trial , 88 patients ( 310 AK lesions ) received ALA-PDT in combination with either visible light ( VIS ) + water-filtered infrared A ( wIRA ) light ( PhotoDyn ( ) 750 ( PD750 ) , 580-1400nm ) for 30 min or incoherent light ( Waldmann ( ) 1200L ( Wa1200L ) , 600-720nm ) for 10-11 min .
METHODS	Follow-up visits were performed after 1 , 3 , 6 , and 12 months .
METHODS	If there was no complete cure after 1 , 3 or 6 months , a second cycle of PDT was performed .
RESULTS	Pain scores were significantly lower in patients illuminated with PD750 rather than Wa1200L .
RESULTS	Patient complete clearance rates were 85 % and 91 % after 1 month , 79 % and 92 % after 3 months , 97 % and 92 % after 6 months , and 69 % and 85 % after 12 months in the PD750 and Wa1200L groups , respectively .
RESULTS	Lesion complete clearance rates were 94 % and 92 % after 1 month , 88 % and 97 % after 3 months , 96 % and 95 % after 6 months , and 81 % and 89 % after 12 months in the PD750 and Wa1200L group , respectively .
RESULTS	The efficacy rates were not significantly different .
CONCLUSIONS	A VIS + wIRA light source produced considerably less pain , while efficacy was not much affected in contrast to previously published studies , probably because the illumination time was longer in this study .

###24337358
OBJECTIVE	Biological explanations of psychopathology can reduce the extent to which people with mental disorders are blamed for their symptoms but can also yield prognostic pessimism -- the belief that psychiatric conditions are relatively immutable .
OBJECTIVE	However , few studies have examined whether these effects occur among persons who actually have psychiatric symptoms .
OBJECTIVE	This study sought to address this question .
METHODS	Adults living in the United States ( N = 351 ) were recruited online in January and February 2012 and assessed for symptoms of generalized anxiety disorder .
METHODS	The participants were randomly assigned to two groups : a biological condition , in which participants ( N = 176 ) were provided a description of generalized anxiety disorder and a biological explanation of the etiology of the disorder , and a control condition , in which participants ( N = 175 ) were provided the same description without any explanation of etiology .
METHODS	Dependent measures of treatability , duration of symptoms , and responsibility for symptoms were used to gauge beliefs regarding the prognosis and personal responsibility of a typical person with generalized anxiety disorder .
RESULTS	Among participants with and without symptoms of generalized anxiety disorder , the biological condition was associated with decreased ascriptions of personal responsibility for anxiety ( p = .02 ) and expectations of increased duration of symptoms of generalized anxiety disorder ( p = .01 ) .
CONCLUSIONS	This finding has important social and clinical implications , especially because biological conceptualizations of psychopathology are increasingly prevalent .
CONCLUSIONS	By causing prognostic pessimism about generalized anxiety disorder , including among those with symptoms of the disorder , biological explanations could negatively affect treatment seeking and outcomes .
CONCLUSIONS	Efforts to dispel the link between biological explanations and prognostic pessimism are needed .

###25349321
BACKGROUND	Perinatal complications predict increased risk for morbidity and early mortality .
BACKGROUND	Evidence of perinatal programming of adult mortality raises the question of what mechanisms embed this long-term effect .
BACKGROUND	We tested a hypothesis related to the theory of developmental origins of health and disease : that perinatal complications assessed at birth predict indicators of accelerated aging by midlife .
METHODS	Perinatal complications , including both maternal and neonatal complications , were assessed in the Dunedin Multidisciplinary Health and Development Study cohort ( N = 1037 ) , a 38-year , prospective longitudinal study of a representative birth cohort .
METHODS	Two aging indicators were assessed at age 38 years , objectively by leukocyte telomere length ( TL ) and subjectively by perceived facial age .
RESULTS	Perinatal complications predicted both leukocyte TL ( = -0.101 ; 95 % confidence interval , -0.169 to -0.033 ; P = .004 ) and perceived age ( = 0.097 ; 95 % confidence interval , 0.029 to 0.165 ; P = .005 ) by midlife .
RESULTS	We repeated analyses with controls for measures of family history and social risk that could predispose to perinatal complications and accelerated aging , and for measures of poor health taken in between birth and the age-38 follow-up .
RESULTS	These covariates attenuated , but did not fully explain the associations observed between perinatal complications and aging indicators .
CONCLUSIONS	Our findings provide support for early-life developmental programming by linking newborns ' perinatal complications to accelerated aging at midlife .
CONCLUSIONS	We observed indications of accelerated aging `` inside , '' as measured by leukocyte TL , an indicator of cellular aging , and `` outside , '' as measured by perceived age , an indicator of declining tissue integrity .
CONCLUSIONS	A better understanding of mechanisms underlying perinatal programming of adult aging is needed .

###24793528
OBJECTIVE	To assess the safety and efficacy of multiple injections of 0.5 and 2.0 mg conbercept using variable dosing regimens in patients with neovascular age-related macular degeneration ( AMD ) .
METHODS	Randomized , double-masked , multicenter , controlled-dose , and interval-ranging phase 2 clinical trial divided into a 3-month loading phase followed by a maintenance phase .
METHODS	Patients with choroidal neovascularization secondary to AMD with lesion sizes of 12 disc areas or less and a best-corrected visual acuity ( BCVA ) letter score of between 73 and 24 were enrolled .
METHODS	Patients were randomized 1:1 to receive either 0.5 or 2.0 mg intravitreal conbercept for 3 consecutive monthly does .
METHODS	After the third dose , each group was reassigned randomly again to monthly ( Q1M group ) or as-needed ( pro re nata [ PRN ] group ) treatment without changing the drug assignment .
METHODS	The primary end point was the mean change in BCVA from baseline to month 3 , with secondary end points being the mean change in BCVA , mean change in central retinal thickness ( CRT ) , and safety at month 12 .
RESULTS	We enrolled 122 patients .
RESULTS	At the primary end point at month 3 , mean improvements in BCVA from baseline in the 0.5 - and 2.0-mg groups were 8.97 and 10.43 letters , respectively .
RESULTS	At month 12 , mean improvements in BCVA from baseline were 14.31 , 9.31 , 12.42 , and 15.43 letters for the 0.5-mg PRN , 0.5-mg Q1M , 2.0-mg PRN , and 2.0-mg Q1M regimens , respectively .
RESULTS	At month 12 , mean reductions in CRT in the 4 regimens were 119.8 , 129.7 , 152.1 , and 170.8 m , respectively .
RESULTS	There were no significant differences for the pairwise comparisons between all study groups .
RESULTS	The difference in the number of injections between the 2 PRN groups was not statistically significant .
RESULTS	Treatment with conbercept generally was safe and well tolerated .
CONCLUSIONS	The significant gains in BCVA at 3 months were the same or better at 12 months in all conbercept dosing groups of neovascular AMD patients .
CONCLUSIONS	During the 12 months , repeated intravitreal injections of conbercept were well tolerated in these patients .
CONCLUSIONS	Future clinical trials are required to confirm its long-term efficacy and safety .

###25764097
BACKGROUND	Acute tympanostomy-tube otorrhea is a common sequela in children with tympanostomy tubes .
BACKGROUND	Acute tympanostomy-tube otorrhea is generally a symptom of an acute middle ear infection , whereby middle ear fluid drains through the tube .
BACKGROUND	The widespread use of pneumococcal conjugate vaccination ( PCV ) has changed the bacterial prevalence in the upper respiratory tract of children , but its impact on bacterial and viral pathogens causing acute tympanostomy-tube otorrhea is yet unknown .
METHODS	This study was performed in the post-PCV7 era parallel to a randomized clinical trial of the clinical and cost-effectiveness of ototopical and systemic antibiotics and initial observation in 230 children aged 1 to 10 years with untreated , uncomplicated acute tympanostomy-tube otorrhea .
METHODS	Otorrhea and nasopharyngeal samples were collected at baseline ( before treatment ) and at 2 weeks ( after treatment ) .
METHODS	Conventional bacterial culture was performed followed by antimicrobial-resistance assessment .
METHODS	Viruses were identified by polymerase chain reaction .
RESULTS	At baseline , Haemophilus influenzae ( 41 % ) , Staphylococcus aureus ( 40 % ) and Pseudomonas aeruginosa ( 18 % ) were the most prevalent bacteria in otorrhea , followed by Streptococcus pneumoniae ( 7 % ) and Moraxella catarrhalis ( 4 % ) .
RESULTS	Most pneumococci were non-PCV7 serotypes .
RESULTS	Viruses were detected in 45 otorrhea samples at baseline ( 21 % ) .
RESULTS	Most infections were polymicrobial and overall antimicrobial resistance was low .
CONCLUSIONS	H. influenzae , S. aureus and P. aeruginosa are the most common microorganisms in children with untreated uncomplicated acute tympanostomy-tube otorrhea .
CONCLUSIONS	Prevalence of S. pneumoniae has decreased since the introduction of PCV and most pneumococci are nonvaccine serotypes .

###25740807
BACKGROUND	To investigate the difference in clinical outcomes between large-diameter deep anterior lamellar keratoplasty ( L-DALK ) and standard DALK ( S-DALK ) for the treatment of keratoconus .
METHODS	132 patients ( 132 eyes ) from the Zhongshan Ophthalmic Center with a clinical diagnosis of keratoconus were enrolled .
METHODS	The participants were featured by the intolerance to rigid gas-permeable contact lenses or unsuccessful fitting of contact lenses .
METHODS	Using stratified blocked randomisation , eligible eyes were allocated into the L-DALK group or the S-DALK group ( 66 eyes , respectively ) .
METHODS	Postoperative uncorrected visual acuity ( UCVA ) , best spectacle-corrected visual acuity ( BSCVA ) , refractive sphere , manifest cylinder and spherical equivalent refractive error were tested at 6 , 12 , 18 and 24months after surgery .
RESULTS	After surgery , the L-DALK group had better UCVA and BSCVA than the S-DALK group ( p = 0.000 and 0.021 , respectively ) .
RESULTS	At 24months , mean BSCVA was 0.170.10 logarithm of the minimum angle of resolution ( logMAR ) ( Snellen equivalent , 20/25 ) in the L-DALK group vs 0.220.10 logMAR ( Snellen equivalent , 20/32 ) in the S-DALK group .
RESULTS	Differences were observed between the L-DALK group and the S-DALK group in terms of refractive sphere ( p = 0.015 ) , manifest cylinder ( p = 0.014 ) and spherical equivalent refractive error ( p = 0.034 ) at any time interval postoperatively .
RESULTS	At 24months , the mean spherical equivalent refractive error was -3.53.2 D and -5.22.6 D in the L-DALK and S-DALK groups , respectively .
CONCLUSIONS	L-DALK can reduce the degree of postoperative myopia and manifest astigmatism and improve visual acuity outcomes in keratoconus compared with S-DALK .
BACKGROUND	Chinese Clinical Trial Registry ( TRC-13003122 ) .

###25336668
OBJECTIVE	Although circumferential pulmonary vein isolation ( CPVI ) has been considered as the cornerstone for paroxysmal atrial fibrillation ( PAF ) ablation , there has been a substantial recurrence rate .
OBJECTIVE	We conducted a prospectively randomized study to evaluate whether additional linear ablation from the superior vena cava ( SVC ) to the right atrial ( RA ) septum ( SVC-L ) improves the clinical outcome .
RESULTS	This study enroled 200 patients with PAF ( male 74.5 % , 56.8 11.7 years old ) randomly assigned to either the CPVI ( n = 100 ) or CPVI + SVC-L ( n = 100 ) groups .
RESULTS	An RA isthmus ablation was performed in all patients .
RESULTS	The CPVI + SVC-L group required a longer ablation procedure time ( 82.7 17.9 min ) than the CPVI group ( 63.6 16.8 min , P < 0.001 ) .
RESULTS	The complication rates were 5 % in CPVI + SVC-L group and 2 % in CPVI group , respectively ( P = 0.445 ) .
RESULTS	Two CPVI + SVC-L group patients had post-procedural sinus node dysfunction , which recovered within 24 h.
RESULTS	During 12.2 5.3 months of follow-up , the recurrence rate was significantly lower in the CPVI + SVC-L group ( 6 % ) than the CPVI group ( 27 % , P < 0.001 ) .
RESULTS	The post-procedural 3-month follow-up heart rate variability in the CPVI + SVC-L group showed a significantly greater reduction in the rMSSD ( 25.2 13.7 vs. 13.7 8.5 ms , P < 0.001 ) , HF ( 10.2 7.1 vs. 5.5 5.8 ms ( 2 ) , P < 0.001 ) , and LF/HF ( 1.6 0.5 vs. 0.9 0.3 , P < 0.001 ) than in the CPVI group .
CONCLUSIONS	In spite of a longer procedure time and risk of transient sinus node dysfunction , an SVC-L in addition to CPVI improved the clinical outcome of catheter ablation , and was associated with post-procedural autonomic neural remodelling in patients with PAF .

###24273968
OBJECTIVE	To compare the clinical efficacy of 3 different treatment programs for oligospermia patients of Shen-essence deficiency syndrome ( SEDS ) .
METHODS	Totally 450 male patients were randomly assigned to 3 groups , i.e. , the treatment group , the control group 1 , and the control group 2 , 150 in each group .
METHODS	Patients in the treatment group were treated by Bushen Yijing Decoction ( BYD ) , tamoxifen tablet ( TT ) , Licorzine Capsule ( LC ) , and Vitamin E Soft Capsule ( VESC ) .
METHODS	Those in the control group 1 were treated by BYD , LC , and VESC .
METHODS	Those in the control group 2 were treated by TT , LC , and VESC .
METHODS	All patients were treated for 3 months .
METHODS	Their pregnant rates were compared .
METHODS	Clinical efficacies of each Chinese medical symptom and sperm parameters [ sperm density , grade a sperm motility rate , grade ( a + b ) sperm motility rate , grade ( a + b + c ) sperm motility rate , and normal sperm morphology rate ] were compared before and after treatment .
RESULTS	At 3 months after treatment 61 patients were pregnant in the treatment group , 36 patients were pregnant in the control group 1 , and 30 patients were pregnant in the control group 2 .
RESULTS	The differences in the sperm density , grade a sperm motility rate , and grade ( a + b ) sperm motility rate , and grade ( a + b + c ) sperm motility rate between before and after treatment were significantly higher in the treatment group than in the control group 1 and the control group 2 ( P < 0.01 ) .
RESULTS	The difference in the normal sperm morphology rate between before and after treatment was obviously higher in the treatment group and the control group 1 than in the control group 2 ( P < 0.01 ) .
RESULTS	Better results were obtained in the treatment group and the control group 1 in improving the sexual apathy , soreness and weakness of waist and knees , impotence , premature ejaculation , seminal emission , dizziness , tinnitus , forgetfulness , alopecia , when compared with the control group 2 ( P < 0.01 , P < 0.05 ) .
RESULTS	There was no statistical difference in the total effective rate of improving Chinese medical symptoms between the treatment group and the control group 1 ( P > 0.05 ) .
CONCLUSIONS	BYD combined with TT , LC , and VESC could significantly improve sperm qualities and clinical Chinese medical symptoms of oligospermia patients of SEDS .

###25958474
OBJECTIVE	Low-level laser therapy ( LLLT ) has been proven to stimulate bone repair , affecting cellular proliferation , differentiation and adhesion , and has shown a potential to reduce the healing time following implant placement .
OBJECTIVE	The aim of this clinical study was to investigate the influence of postoperative LLLT osseointegration and early success of self-tapping implants placed into low-density bone .
METHODS	Following the split-mouth design , self-tapping implants n = 44 ) were inserted in the posterior maxilla of 12 patients .
METHODS	One jaw side randomly received LLLT ( test group ) , while the other side was placebo ( control group ) .
METHODS	For LLLT , a 637 nm gallium-aluminum-arsenide ( GaAlAs ) laser ( Medicolaser 637 , Technoline , Belgrade , Serbia ) with an output power of 40 mW and continuous wave was used .
METHODS	Low-level laser treatment was performed immediately after the surgery and then repeated every day in the following 7 days .
METHODS	The total irradiation dose per treatment was 6.26 J/cm2 per implant .
METHODS	The study outcomes were : implant stability , alkaline-phosphatase ( ALP ) activity and early implant success rate .
METHODS	The follow-up took 6 weeks .
RESULTS	Irradiated implants achieved a higher stability compared with controls during the entire follow-up and the difference reached significance in the 5th postoperative week ( paired t-test , p = 0.030 ) .
RESULTS	The difference in ALP activity between the groups was insignificant in any observation point ( paired t-test , p > 0.05 ) .
RESULTS	The early implant success rate was 100 % , regardless of LLLT usage .
CONCLUSIONS	LLLT applied daily during the first postoperative week expressed no significant influence on the osseointegration of self-tapping implants placed into low density bone of the posterior maxilla .
CONCLUSIONS	Placement of self-tapping macro-designed implants into low density bone could be a predictable therapeutic procedure with a high early success rate regardless of LLLT usage .

###24697033
OBJECTIVE	Routine placement of JJ ure teric stents , following uncomplicated endoscopic removal of a ureteral stone , still remains debatable .
OBJECTIVE	Indwelling JJ stents are not without any risks .
OBJECTIVE	They often can cause marked discomfort , or even pain .
OBJECTIVE	The aim of this study was to prospectively evaluate patient 's perceived pain due to renal colic and indwelling JJ stent left following ure terorenoscopic lithotripsy ( URSL ) .
METHODS	54 patients with colicky pain due to distal ureteric stone , and who underwent uncompli cated ureterorenoscopic lithotripsy , were included in the study .
METHODS	Follow ing URSL , patients were randomly selected to have either JJ stent left in situ ( Group I ) , or remain without a stent ( Group II ) .
METHODS	Among all study par ticipants levels of pain prior , as well as 14 days after the procedure were evalu ated with the use of a visual analogue pain scale .
RESULTS	Pain perception at the time of colic did not vary between men and women ( 6.30 + / - 1.33 and 6.38 + / - 1.11 , respectively , p = 0.293 ) .
RESULTS	Similarly , no differences in perceived pain were noted 14 days following URSL .
RESULTS	Mean pain score in patients with indwelling JJ stent was 2.12 + / - 1.23 as compared to 2.15 + / - 0.67 in those without it ( p = 0.148 ) .
CONCLUSIONS	No increase in pain levels due to indwelling JJ stent could be observed .
CONCLUSIONS	Further research to allow for better assessment of discomfort and pain caused by an indwelling JJ stent on a larger cohort , and which could also discriminate patients ' psy chosomatic symptoms , is needed .

###25109375
BACKGROUND	Adherence to controller therapy in allergic diseases is low .
BACKGROUND	Telemonitoring has been proposed to improve adherence to treatment in chronic diseases .
BACKGROUND	However , this strategy has never been tested in allergic rhinoconjunctivitis .
OBJECTIVE	To test whether Internet-based telemonitoring during the grass-pollen season of children with allergic rhinoconjunctivitis may enhance adherence to treatment .
METHODS	Children and adolescents , 5-18years old , with moderate-to-severe seasonal allergic rhinoconjunctivitis to grass pollen requiring daily administration of nasal corticosteroid ( NCS ) ( mometasone ) were recruited ( April 2013 ) in a paediatric allergy practice .
METHODS	Participants were randomized to Internet-based monitoring ( AllergyMonitor ( ) , AM ) or to usual care ( no diary at all , controls ) and followed from 13 May ( T0 ) to 15 June 2013 ( T2 ) .
METHODS	An intermediate visit ( T1 ) was performed between 31 May and 2 June .
METHODS	Optimal adherence to therapy was expressed as the use of at least 0.190 g/day of mometasone , corresponding to 1puff/nostril/day , and it was measured by canister weights during ( T1 ) and at the end ( T2 ) of the study period .
METHODS	Main secondary outcomes included the reported disease severity ( validated self-questionnaire ) and quality of life ( AdoIRQLQ questionnaire ) , disease knowledge ( multiple-choice questionnaire ) , nasal flow and resistance at baseline and at T2 .
RESULTS	The use of mometasone , expressed as both optimal adherence rate ( 48.4 % vs. 12.5 % ; P = 0.002 ) and average daily use ( 0.200.12 g/day vs. 0.150.07 g/day ; P = 0.037 ) , was higher in the AM group ( n = 31 ) than among controls ( n = 32 ) .
RESULTS	Disease knowledge improved among the patients using AM ( 83.3 % vs. 68.3 % ; P < 0.001 ) but not among controls ( 68.2 % vs. 67.7 % right answers ; P > 0.05 ) .
RESULTS	No differences were observed in the reported severity of disease , nasal flow and resistance and quality of life both at baseline and at follow-up visits .
CONCLUSIONS	Internet-based telemonitoring improves adherence to NCS treatment and disease knowledge among children and adolescents with seasonal allergic rhinoconjunctivitis .

###24922355
OBJECTIVE	The aim of this study was to evaluate the combination of endoscopic ultrasonography ( EUS ) and computed tomography ( CT ) in predicting the maneuvers for therapeutic endoscopy for gastrointestinal submucosal tumors ( SMTs ) .
METHODS	Patients with SMTs , who were scheduled for endoscopic resection , were randomized to preoperative performance of both EUS and CT ( group A ) or EUS only ( group B ) .
METHODS	The following data were collected : therapeutic maneuvers , duration of procedure , dose of propofol , resected lesion size , and complications .
RESULTS	A total of 36 patients were included in group A and 36 patients were included in group B. Endoscopic submucosal excavation was performed in 43 patients , endoscopic full-thickness resection in 18 patients , and submucosal tunneling endoscopic resection in 11 patients .
RESULTS	No significant differences were observed between the two groups ( P > 0.05 ) .
RESULTS	The coincidence rate between the preoperative program and the actual endoscopic procedures in group A was higher than that in group B ( 83.3 vs. 61.1 % , P < 0.05 ) .
RESULTS	The procedural time in group A was less than that in group B ( 39.3617.83 vs. 48.0612.03 min , P < 0.05 ) , and the dose of propofol in group A was less than that in group B ( 249.18125.12 vs. 304.16102.61 mg , P < 0.05 ) .
RESULTS	The mean resected lesion size was 2.321.46 cm in group A and 2.120.75 cm in group B , without differences ( P > 0.05 ) .
RESULTS	A total of 14 cardiopulmonary complications and seven endoscopic complications occurred , without significant differences between the two groups ( P > 0.05 ) .
CONCLUSIONS	EUS combined with CT can better evaluate SMTs compared with EUS only in predicting the maneuvers for therapeutic endoscopy .

###24816611
BACKGROUND	Sedentary behavior may independently contribute to morbidity and mortality among survivors of colorectal cancer .
BACKGROUND	In the current study , the authors assessed whether a telephone-delivered multiple health behavior change intervention had an effect on the sedentary behavior of recently diagnosed colorectal cancer survivors .
METHODS	A total of 410 participants were recruited through the Queensland Cancer Registry and randomized to the health coaching ( intervention ) or usual-care ( control ) group .
METHODS	Eleven health coaching sessions addressing multiple health behaviors , including sedentary behavior , were delivered over a period of 6 months .
METHODS	Data were collected at baseline ( before randomization ) , at 6 months , and at 12 months via a telephone interview .
RESULTS	At 12 months , there was a significant decrease noted in the hours per day of sedentary time in both the health coaching ( -1.21 ; 95 % confidence interval [ 95 % CI ] , -1.71 to -0.70 ) and usual-care groups ( -0.55 ; 95 % CI , -1.06 to -0.05 ) , but the between-group difference was not found to be statistically significant ( -0.65 ; 95 % CI , -1.37 to 0.06 [ P = .07 ] ) .
RESULTS	In stratified subgroup analyses , the multiple health behavior change intervention was found to have a significant effect on total sedentary time ( hours/day ) at 12 months in survivors of colorectal cancer who were aged > 60 years ( -0.90 ; 95 % CI , -1.80 to -0.01 [ P = .05 ] ) , male ( -1.33 ; 95 % CI , -2.44 to -0.21 [ P = .02 ] ) , and nonobese ( -1.10 ; 95 % CI , -1.96 to -0.25 ; [ P = .01 ] ) .
CONCLUSIONS	Incorporating simple messages about limiting sedentary behaviors into a multiple health behavior change intervention was found to have modest effects on sedentary behavior .
CONCLUSIONS	A sedentary behavior-specific intervention strategy may be required to achieve substantial changes in sedentary behavior among colorectal cancer survivors .

###24553094
BACKGROUND	Long-term nitrate treatment of stable angina is associated with side effects that can interfere with health-related quality of life ( HRQoL ) and medication adherence .
BACKGROUND	The aim of the present study was to compare HRQoL and adherence to treatment in patients with stable angina undergoing nitrate withdrawal or maintenance .
METHODS	This study is a randomized clinical trial .
METHODS	Patients were allocated to an intervention group ( nitrate withdrawal followed by introduction of placebo ) or a control group ( nitrate maintenance ) .
METHODS	The assessments were made at baseline and 30 and 120 days using the Short Form Health Survey and the Seattle Angina Questionnaire .
METHODS	Treatment adherence was measured on the basis of the Morisky scale and pill count .
RESULTS	A total of 105 patients with stable angina were randomized for replacement of nitrate with placebo ( n = 51 ) and for maintenance of treatment with nitrate ( n = 54 ) .
RESULTS	After 4 months , Short Form Health Survey scores increased for bodily pain ( P = 0.005 ) and general health ( P = 0.004 ) in the nitrate maintenance group .
RESULTS	Decreased Seattle Angina Questionnaire scores were also noted for physical limitations ( P = 0.039 ) and angina frequency ( P = 0.011 ) in the nitrate maintenance group .
RESULTS	However , the effect size was small ( 0.44 ) when the intervention and control groups were compared .
RESULTS	At the end of the study , adherence was significantly higher in the placebo group ( P = 0.041 ) , but no difference was detected between the groups with the pill count method .
CONCLUSIONS	HRQoL was similar in patients with stable angina using nitrate regularly as compared with patients undergoing nitrate withdrawal .
CONCLUSIONS	However , adherence to treatment was lower in nitrate users according to the Morisky scale .

###26026919
OBJECTIVE	Research on immediate neonatal resuscitation suggests that maternal magnesium exposure may be associated with increased risk of low Apgar scores , hypotonia , and neonatal intensive care unit admission .
OBJECTIVE	However , not all studies support these associations .
OBJECTIVE	Our objective was to determine whether exposure to magnesium at the time of delivery affects initial neonatal resuscitation .
METHODS	This is a secondary analysis of the Randomized Controlled Trial of Magnesium Sulfate for the Prevention of Cerebral Palsy that evaluated whether the study drug ( magnesium or placebo ) that was administered at the time of delivery was associated with increased risk for a composite adverse neonatal resuscitation outcome ( 5-minute Apgar score < 7 , oxygen administration in the delivery room , intubation , chest compressions , hypotension , and hypotonicity ) .
METHODS	A subgroup analysis was performed among patients who delivered at 30 weeks of gestation .
METHODS	Log-linear regression was used to control for possible confounders .
RESULTS	Data for 1047 patients were analyzed , of whom 461 neonates ( 44 % ) were exposed to magnesium .
RESULTS	There was no increased risk for the primary composite outcome associated with magnesium exposure .
RESULTS	Individual adverse neonatal outcomes and other secondary short-term neonatal outcomes that were evaluated also did not demonstrate an association with magnesium exposure .
CONCLUSIONS	Exposure to magnesium sulfate did not affect neonatal resuscitation or other short-term outcomes .
CONCLUSIONS	These findings may be useful in planning neonatal care and patient counseling .

###25657175
OBJECTIVE	Controversy persists over statins and risk of intracerebral hemorrhage .
OBJECTIVE	We determined associations of premorbid lipid-lowering therapy and outcomes among participants of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trials ( INTERACT ) .
METHODS	The pooled data of INTERACT 1 and 2 ( international , multicenter , prospective , open , blinded end point , randomized controlled trials of patients with intracerebral hemorrhage [ < 6 hours ] and elevated systolic blood pressure ) were analyzed with regard to associations of baseline lipid-lowering treatment and clinical outcomes of 3184 participants in a multivariate model .
METHODS	Associations of lipid-lowering therapy and hematoma growth ( baseline to 24 hours ) in computed tomographic substudies participants ( n = 1310 ) were estimated in ANCOVA .
RESULTS	Among 204 patients ( 6.5 % ) with baseline lipid-lowering treatment , 90-day clinical outcomes were not significantly different after adjustment for confounding variables including region and age .
RESULTS	In the computed tomographic substudy , 24-hour hematoma growth was greater in 124 patients ( 9 % ) with , compared with those without , prior lipid-lowering therapy .
RESULTS	However , this association was not significant between groups ( 9.2 versus 6.8 mL ; P < 0.13 ) , after adjustment for prior antithrombotic therapy .
CONCLUSIONS	No independent associations were found between lipid-lowering medication and adverse outcomes in patients with intracerebral hemorrhage .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00226096 and NCT00716079 .

###26305649
OBJECTIVE	Observational data have suggested that high dietary intake of saturated fat and low intake of vegetables may be associated with increased risk of Alzheimer disease .
OBJECTIVE	To test the effects of oral supplementation with nutrients on cognitive function .
METHODS	In a double-masked randomized clinical trial ( the Age-Related Eye Disease Study 2 [ AREDS2 ] ) , retinal specialists in 82 US academic and community medical centers enrolled and observed participants who were at risk for developing late age-related macular degeneration ( AMD ) from October 2006 to December 2012 .
METHODS	In addition to annual eye examinations , several validated cognitive function tests were administered via telephone by trained personnel at baseline and every 2 years during the 5-year study .
METHODS	Long-chain polyunsaturated fatty acids ( LCPUFAs ) ( 1 g ) and/or lutein ( 10 mg ) / zeaxanthin ( 2 mg ) vs placebo were tested in a factorial design .
METHODS	All participants were also given varying combinations of vitamins C , E , beta carotene , and zinc .
METHODS	The main outcome was the yearly change in composite scores determined from a battery of cognitive function tests from baseline .
METHODS	The analyses , which were adjusted for baseline age , sex , race , history of hypertension , education , cognitive score , and depression score , evaluated the differences in the composite score between the treated vs untreated groups .
METHODS	The composite score provided an overall score for the battery , ranging from -22 to 17 , with higher scores representing better function .
RESULTS	A total of 89 % ( 3741/4203 ) of AREDS2 participants consented to the ancillary cognitive function study and 93.6 % ( 3501/3741 ) underwent cognitive function testing .
RESULTS	The mean ( SD ) age of the participants was 72.7 ( 7.7 ) years and 57.5 % were women .
RESULTS	There were no statistically significant differences in change of scores for participants randomized to receive supplements vs those who were not .
RESULTS	The yearly change in the composite cognitive function score was -0.19 ( 99 % CI , -0.25 to -0.13 ) for participants randomized to receive LCPUFAs vs -0.18 ( 99 % CI , -0.24 to -0.12 ) for those randomized to no LCPUFAs ( difference in yearly change , -0.03 [ 99 % CI , -0.20 to 0.13 ] ; P = .63 ) .
RESULTS	Similarly , the yearly change in the composite cognitive function score was -0.18 ( 99 % CI , -0.24 to -0.11 ) for participants randomized to receive lutein/zeaxanthin vs -0.19 ( 99 % CI , -0.25 to -0.13 ) for those randomized to not receive lutein/zeaxanthin ( difference in yearly change , 0.03 [ 99 % CI , -0.14 to 0.19 ] ; P = .66 ) .
RESULTS	Analyses were also conducted to assess for potential interactions between LCPUFAs and lutein/zeaxanthin and none were found to be significant .
CONCLUSIONS	Among older persons with AMD , oral supplementation with LCPUFAs or lutein/zeaxanthin had no statistically significant effect on cognitive function .
BACKGROUND	clinicaltrials.gov Identifier : NCT00345176 .

###24716610
BACKGROUND	Increasing epithelial repair and regeneration may hasten resolution of lung injury in patients with the acute respiratory distress syndrome ( ARDS ) .
BACKGROUND	In animal models of ARDS , keratinocyte growth factor ( KGF ) reduces injury and increases epithelial proliferation and repair .
BACKGROUND	The effect of KGF in the human alveolus is unknown .
OBJECTIVE	To test whether KGF can attenuate alveolar injury in a human model of ARDS .
METHODS	Volunteers were randomized to intravenous KGF ( 60 g/kg ) or placebo for 3 days , before inhaling 50 g LPS .
METHODS	Six hours later , subjects underwent bronchoalveolar lavage ( BAL ) to quantify markers of alveolar inflammation and cell-specific injury .
RESULTS	KGF did not alter leukocyte infiltration or markers of permeability in response to LPS .
RESULTS	KGF increased BAL concentrations of surfactant protein D , matrix metalloproteinase ( MMP ) -9 , IL-1Ra , granulocyte-macrophage colony-stimulating factor ( GM-CSF ) , and C-reactive protein .
RESULTS	In vitro , BAL fluid from KGF-treated subjects inhibited pulmonary fibroblast proliferation , but increased alveolar epithelial proliferation .
RESULTS	Active MMP-9 increased alveolar epithelial wound repair .
RESULTS	Finally , BAL from the KGF-pretreated group enhanced macrophage phagocytic uptake of apoptotic epithelial cells and bacteria compared with BAL from the placebo-treated group .
RESULTS	This effect was blocked by inhibiting activation of the GM-CSF receptor .
CONCLUSIONS	KGF treatment increases BAL surfactant protein D , a marker of type II alveolar epithelial cell proliferation in a human model of acute lung injury .
CONCLUSIONS	Additionally , KGF increases alveolar concentrations of the antiinflammatory cytokine IL-1Ra , and mediators that drive epithelial repair ( MMP-9 ) and enhance macrophage clearance of dead cells and bacteria ( GM-CSF ) .
CONCLUSIONS	Clinical trial registered with ISRCTN 98813895 .

###25219348
OBJECTIVE	This randomized controlled trial tested the efficacy of early intervention to prevent adult psychopathology and improve well-being in early-starting conduct-problem children .
METHODS	Kindergarteners ( N = 9,594 ) in three cohorts ( 1991-1993 ) at 55 schools in four communities were screened for conduct problems , yielding 979 early starters .
METHODS	A total of 891 ( 91 % ) consented ( 51 % African American , 47 % European American ; 69 % boys ) .
METHODS	Children were randomly assigned by school cluster to a 10-year intervention or control .
METHODS	The intervention goal was to develop social competencies in children that would carry them throughout life , through social skills training , parent behavior-management training with home visiting , peer coaching , reading tutoring , and classroom social-emotional curricula .
METHODS	Manualization and supervision ensured program fidelity .
METHODS	Ninety-eight percent participated during grade 1 , and 80 % continued through grade 10 .
METHODS	At age 25 , arrest records were reviewed ( N = 817 , 92 % ) , and condition-blinded adults psychiatrically interviewed participants ( N = 702 ; 81 % of living participants ) and a peer ( N = 535 ) knowledgeable about the participant .
RESULTS	Intent-to-treat logistic regression analyses indicated that 69 % of participants in the control arm displayed at least one externalizing , internalizing , or substance abuse psychiatric problem ( based on self - or peer interview ) at age 25 , in contrast with 59 % of those assigned to intervention ( odds ratio = 0.59 , CI = 0.43-0 .81 ; number needed to treat = 8 ) .
RESULTS	This pattern also held for self-interviews , peer interviews , scores using an `` and '' rule for self - and peer reports , and separate tests for externalizing problems , internalizing problems , and substance abuse problems , as well as for each of three cohorts , four sites , male participants , female participants , African Americans , European Americans , moderate-risk , and high-risk subgroups .
RESULTS	Intervention participants also received lower severity-weighted violent ( standardized estimate = -0.37 ) and drug ( standardized estimate = -0.43 ) crime conviction scores , lower risky sexual behavior scores ( standardized estimate = -0.24 ) , and higher well-being scores ( standardized estimate = 0.19 ) .
CONCLUSIONS	This study provides evidence for the efficacy of early intervention in preventing adult psychopathology among high-risk early-starting conduct-problem children .

###25542620
BACKGROUND	Most patients with Crohn 's disease need an intestinal resection , but a majority will subsequently experience disease recurrence and require further surgery .
BACKGROUND	This study aimed to identify the optimal strategy to prevent postoperative disease recurrence .
METHODS	In this randomised trial , consecutive patients from 17 centres in Australia and New Zealand undergoing intestinal resection of all macroscopic Crohn 's disease , with an endoscopically accessible anastomosis , received 3 months of metronidazole therapy .
METHODS	Patients at high risk of recurrence also received a thiopurine , or adalimumab if they were intolerant to thiopurines .
METHODS	Patients were randomly assigned to parallel groups : colonoscopy at 6 months ( active care ) or no colonoscopy ( standard care ) .
METHODS	We used computer-generated block randomisation to allocate patients in each centre to active or standard care in a 2:1 ratio .
METHODS	For endoscopic recurrence ( Rutgeerts score i2 ) at 6 months , patients stepped-up to thiopurine , fortnightly adalimumab with thiopurine , or weekly adalimumab .
METHODS	The primary endpoint was endoscopic recurrence at 18 months .
METHODS	Patients and treating physicians were aware of the patient 's study group and treatment , but central reading of the endoscopic findings was undertaken blind to the study group and treatment .
METHODS	Analysis included all patients who received at least one dose of study drug .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00989560 .
RESULTS	Between Oct 13 , 2009 , and Sept 28 , 2011 , 174 ( 83 % high risk across both active and standard care groups ) patients were enrolled and received at least one dose of study drug .
RESULTS	Of 122 patients in the active care group , 47 ( 39 % ) stepped-up treatment .
RESULTS	At 18 months , endoscopic recurrence occurred in 60 ( 49 % ) patients in the active care group and 35 ( 67 % ) patients in the standard care group ( p = 0.03 ) .
RESULTS	Complete mucosal normality was maintained in 27 ( 22 % ) of 122 patients in the active care group versus four ( 8 % ) in the standard care group ( p = 0.03 ) .
RESULTS	In the active care arm , of those with 6 months recurrence who stepped up treatment , 18 ( 38 % ) of 47 patients were in remission 12 months later ; conversely , of those in remission at 6 months who did not change therapy recurrence occurred in 31 ( 41 % ) of 75 patients 12 months later .
RESULTS	Smoking ( odds ratio [ OR ] 2.4 , 95 % CI 1.2-4 .8 , p = 0.02 ) and the presence of two or more clinical risk factors including smoking ( OR 2.8 , 95 % CI 1.01-7 .7 , p = 0.05 ) increased the risk of endoscopic recurrence .
RESULTS	The incidence and type of adverse and severe adverse events did not differ significantly between patients in the active care and standard care groups ( 100 [ 82 % ] of 122 vs 45 [ 87 % ] of 52 ; p = 0.51 ) and ( 33 [ 27 % ] of 122 vs 18 [ 35 % ] of 52 ; p = 0.36 ) , respectively .
CONCLUSIONS	Treatment according to clinical risk of recurrence , with early colonoscopy and treatment step-up for recurrence , is better than conventional drug therapy alone for prevention of postoperative Crohn 's disease recurrence .
CONCLUSIONS	Selective immune suppression , adjusted for early recurrence , rather than routine use , leads to disease control in most patients .
CONCLUSIONS	Clinical risk factors predict recurrence , but patients at low risk also need monitoring .
CONCLUSIONS	Early remission does not preclude the need for ongoing monitoring .
BACKGROUND	AbbVie , Gutsy Group , Gandel Philanthropy , Angior Foundation , Crohn 's Colitis Australia , and the National Health and Medical Research Council .

###24618208
BACKGROUND	Oxidative stress plays an important role in atherosclerosis .
BACKGROUND	Both F2-isoprostane ( 8-iso-PGF2a ) and oxidized low-density lipoprotein ( ox-LDL ) have emerged as biomarkers of oxidative stress and have been proposed as useful biomarkers that could potentially be used as indicators of cardiovascular disease .
METHODS	This is a prespecified analysis of a prospective , randomized , open-label , blinded endpoint ( PROBE ) study ( ClinicalTrials.gov identifier : NCT01010516 ) .
METHODS	Patients ( N = 100 ) with mixed dyslipidemia on a standard statin dose ( 10-40mg simvastatin or 10-20mg atorvastatin or 5-10mg rosuvastatin ) who had not achieved lipid targets were randomized to switch to the highest dose of rosuvastatin ( 40mg/day ) or to add-on-statin extended release nicotinic acid ( ER-NA ) / laropiprant ( LRPT ) ( 1000/20mg/day for the first 4weeks followed by 2000/40mg/day for the next 8weeks ) or to add-on-statin micronized fenofibrate ( 200mg/day ) for a total of 3months .
METHODS	Levels of plasma and urine F2-isoprostane and plasma ox-LDL were assessed at baseline and 3months later .
RESULTS	Plasma F2-isoprostane levels decreased similarly in all groups .
RESULTS	On the other hand , both ox-LDL and urine F2-isoprostane levels decreased similarly in the add-on ER-NA/LRPT and rosuvastatin monotherapy group , while a less pronounced decrease was observed in the add-on fenofibrate group .
CONCLUSIONS	All treatment interventions reduced the concentration of the assessed oxidative stress markers , but the reduction was more pronounced in the add-on ER-NA/LRPT and rosuvastatin monotherapy groups , compared with add-on fenofibrate .
CONCLUSIONS	Specifically designed studies should address the abovementioned risk factors modulation in terms of cardiovascular risk .

###24363619
BACKGROUND	The aim of this study was to detect the effect of the laryngeal mask airway ( LMA ) versus the endotracheal tube ( ETT ) on postoperative nasal bleedings in and outside the operation room ( OR ) after intranasal surgery .
METHODS	134 patients undergoing elective intranasal surgeries were randomly allocated to receive LMA or ETT during general anesthesia .
METHODS	The incidence , episodes , and severity of nasal bleeding were evaluated in the OR and within the postoperative 24 hours in the ward .
METHODS	Furthermore , medical assistance and severe complications were assessed .
RESULTS	THE overall incidence of postoperative nasal bleeding throughout the observation period was similar between the two groups .
RESULTS	The LMA reduced nasal bleeding in the OR .
RESULTS	However , outside the OR , the incidence of the first episode of postoperative nasal bleeding in the LMA group was higher than that in the ETT group ( difference : -26.5 % ; 95 % CI : -42.2 % to -10.7 % ; P < 0.001 ) .
RESULTS	In the LMA group , more patients needed medical assistance ( P = 0.029 ) , and the number of assistance was also higher ( P = 0.027 ) in the ward .
RESULTS	No severe complications occurred during the observation period .
CONCLUSIONS	The LMA does not alleviate nasal bleeding conditions and even increases the demands of medical service outside the OR after intranasal surgery , although it reduces epistaxis during extubation .

###24906579
BACKGROUND	Relaxation training can be an important adjunct in reducing symptoms associated with Parkinson 's disease ( PD ) .
BACKGROUND	Autogenic Training ( AT ) is a simple , easily administered and inexpensive technique for retraining the mind and the body to be able to relax .
BACKGROUND	AT uses visual imagery and body awareness to promote a state of deep relaxation .
OBJECTIVE	To investigate whether AT when used as an adjunct to Physiotherapy ( PT ) improves motor performances in PD in comparison with a control group receiving PT alone .
METHODS	Randomized , controlled , single blinded trial .
METHODS	Movement Disorder Clinic and Department of Physiotherapy , Sree Chithira Thirunal Institute of Medical Sciences and Technology in Trivandrum , Kerala , India .
METHODS	Patients with PD of grade 2 or 3 of Hoehn & Yahr ( H&Y ) scale ( N = 66 ) .
METHODS	AT group or control group .
METHODS	The techniques were administered by Physiotherapists trained in AT and consisted of 40 sessions per patient over 8 weeks .
METHODS	Motor score subscale of Unified Parkinson 's Disease Rating Scale ( UPDRS ) was used to measure the motor performances .
METHODS	The primary outcome measure was the difference in Motor score subscale of UPDRS scores between Week 1 ( pretest score ) , Week 8 ( posttest score ) , and follow-up at Week 12 after randomization .
RESULTS	The simple main effects analysis showed that the AT group performed better than the control group in weeks 8 and 12 ( P < .005 ) .
RESULTS	Patients in the AT and control groups reported a 51.78 % and 35.24 % improvement , respectively , in their motor performances in Week 8 compared with that in Week 1 , which persisted , in the follow-up ( Week 12 ) as 30.82 % in the AT group and 21.42 % in the control group .
CONCLUSIONS	This study provides evidence that AT when used as an adjunct to PT is more effective than PT alone in improving motor performances in PD patients .

###26201227
OBJECTIVE	To evaluate the margin quality of direct resin composite restorations comparing the enamel-dentin adhesive standard procedure with additional use of adhesive layer at the external outline .
METHODS	A total of 648 teeth with Class I occlusal lesions in molars and premolars were randomly selected and distributed into two groups of 324 each in order to compare the margin quality with two restoration strategies .
METHODS	Lesions were sealed with the standard adhesion procedure for direct resin composite restorations ( Group 1 ) and with an additional procedure of enamel adhesive on the outer boundary of the finished restoration ( Group 2 ) .
METHODS	Evaluation of marginal quality at 6 , 12 , 24 , 36 and 48 months was performed and described as good marginal adaption or as poor quality defined as Inadequacy A ( IA ) : overhanging resin or change of color ; Inadequacy B ( IB ) : the presence of a gap at the enamel-composite interface that retained the probe tip ; or Inadequacy C ( IC ) presence of gap at the enamel-composite interface with explorer tip penetration of more than 1 mm .
RESULTS	Data showed a higher number of Inadequacy A for restorations with the additional technique for marginal seal ( Group 2 ) : 16 of 24 total ( 57 % ) at 6 months ; 28 of 37 total ( 76 % ) at 12 months ; 36 of 44 total ( 82 % ) at 18 months ; 22 of 33 total ( 67 % ) at 24 months ; 14 of 21 total ( 70 % ) at 36 months and 16 of 25 total ( 64 % ) at 48 months .
RESULTS	The Inadequacy B and C of marginal seal were more prevalent for restorations without the additional marginal seal ( Group 1 ) : 18 of 28 total ( 64 % ) at 12 months with inadequacy B ; 19 of 25 total ( 76 % ) with inadequacy B and 16 total ( 100 % ) with inadequacy C at 18 months ; 9 of 17 total ( 53 % ) with Inadequacy B and 13 total ( 100 % ) with Inadequacy C at 24 months ; 12 of 17 total ( 70 % ) with Inadequacy B and 9 of 13 total ( 73 % ) with Inadequacy C at 36 months ; 14 of 24 total ( 58 % ) with Inadequacy B and 7 of 11 total ( 63 % ) with Inadequacy C at 48 months .

###24607755
OBJECTIVE	The purpose of this study was to evaluate the relationship between gestational age ( GA ) and induction of labor ( IOL ) and the rate of cesarean delivery in women with mild gestational diabetes mellitus .
METHODS	We conducted a secondary analysis of data from a multicenter randomized controlled trial of mild gestational diabetes mellitus treatment .
METHODS	Cesarean delivery rate of women delivering at term ( 37 weeks ' gestation ) was evaluated by 2 complementary approaches : ( 1 ) IOL vs spontaneous labor : women who were induced at each GA compared with those who spontaneously labored at the same GA and ( 2 ) IOL vs expectant management : women who delivered after IOL at each GA compared with those who delivered after spontaneous labor at the same GA or subsequently after spontaneous or induced labor ( outcome at each week compared with expectant management at that week ) .
METHODS	Logistic regression adjusted for potential confounders .
RESULTS	The overall cesarean delivery rate was 13 % .
RESULTS	When compared with 39 weeks ' gestation ( either IOL or spontaneous labor ) as the referent , there was no significant difference in the cesarean delivery rate in women who delivered at 37 , 38 , or 40 weeks ' gestation .
RESULTS	However , IOL was associated with a 3-fold increase in cesarean delivery rate at 41 weeks ' gestation and beyond , as compared with IOL at 39 weeks ' gestation .
RESULTS	Similarly , there was a 3-fold increase in the cesarean delivery rate in women who were induced when compared with those who were treated expectantly at 40 completed weeks ' gestation .
CONCLUSIONS	Induction of labor in women with mild gestational diabetes mellitus does not increase the rate of cesarean delivery at < 40 weeks ' gestation .

###24552155
OBJECTIVE	To investigate the optimal dosage/regimen and to evaluate the efficacy and safety of albiglutide in Japanese patients with type 2 diabetes mellitus .
METHODS	This was a randomized , double-blind , placebo-controlled , multicenter , parallel-group , dose-ranging , superiority study in Japanese patients with type 2 diabetes mellitus .
METHODS	Patients ( n = 215 ) who were treatment naive or washed out of one oral antidiabetic drug were randomized to placebo or albiglutide 15mg weekly , 30mg weekly , or 30mg every other week ( biweekly ) .
BACKGROUND	NCT01098461 .
METHODS	The primary end point was the change from baseline in HbA1c at week 16 , measured using the Japan Diabetes Society standardization scheme and presented here using the National Glycohemoglobin Standardization Program equivalents .
METHODS	Other measures of efficacy as well as safety and population pharmacokinetics and pharmacokinetics/pharmacodynamics of albiglutide were assessed .
RESULTS	Baseline HbA1c was 8.53 % .
RESULTS	There was a statistically significant difference between each albiglutide treatment group and placebo for change from baseline in HbA1c at week 16 , with treatment effects of -0.89 % for 15mg weekly , -1.55 % for 30mg weekly , and -1.10 % for 30mg biweekly ( P < 0.0001 for all groups vs placebo ) .
RESULTS	By week 16 , 63.0 % and 33.3 % of patients in the 30mg weekly albiglutide group compared with 6.0 % and 0 % of patients in the placebo group achieved HbA1c < 7.4 % and < 6.9 % , respectively .
RESULTS	No serious adverse events were related to study therapy ; no deaths occurred .
RESULTS	Nasopharyngitis was the most frequently reported adverse event in all treatment groups ( n = 43 [ 20.3 % ] ) .
CONCLUSIONS	Albiglutide exhibited therapeutic hypoglycemic effects with good tolerability among Japanese patients with type 2 diabetes mellitus ; the 30mg weekly dose was the most efficacious in this study .
CONCLUSIONS	The 16 week duration of the study prevents generalizing these conclusions to longer treatment periods .

###24787529
BACKGROUND	Currently , instructional effects generated by Cognitive load theory ( CLT ) are limited to visual and auditory cognitive processing .
BACKGROUND	In contrast , `` embodied cognition '' perspectives suggest a range of gestures , including pointing , may act to support communication and learning , but there is relatively little research showing benefits of such `` embodied learning '' in the health sciences .
OBJECTIVE	This study investigated whether explicit instructions to gesture enhance learning through its cognitive effects .
METHODS	Forty-two university-educated adults were randomly assigned to conditions in which they were instructed to gesture , or not gesture , as they learnt from novel , paper-based materials about the structure and function of the human heart .
METHODS	Subjective ratings were used to measure levels of intrinsic , extraneous and germane cognitive load .
RESULTS	Participants who were instructed to gesture performed better on a knowledge test of terminology and a test of comprehension ; however , instructions to gesture had no effect on subjective ratings of cognitive load .
CONCLUSIONS	This very simple instructional re-design has the potential to markedly enhance student learning of typical topics and materials in the health sciences and medicine .

###24559020
BACKGROUND	Various trials have been conducted on the management and treatment of androgenic alopecia ( AGA ) or male pattern hair loss using a variety of laser and light sources .
METHODS	For this feasibility study , the population was composed of males between the ages of 20 and 60years who have been experiencing active hair loss within the last 12months and the diagnosis of AGA .
METHODS	They also had a Norwood-Hamilton classification of 3 , 3A , 3V , 4 , 4A , or 5 for the hair thinning patterns and skin type I , II , III , or IV on the Fitzpatrick skin type scale .
METHODS	This two-arm randomized , parallel group study design employed stratifying randomization to balance treatment assignment within three investigational centers with at least 2 subjects enrolled in each Fitzpatrick skin type .
RESULTS	A statistically significant positive trend in hair growth was observed from this pilot study , to evaluate the efficacy of the novel cold X5 hairlaser device for treating male androgenic alopecia .
RESULTS	From the repeated measures analysis of variance , difference in mean hair counts over time was statistically significant ( F = 7.70 ; p-value < 0.0001 ) .
RESULTS	Subsequent , linear regression of mean hair counts at each time point was performed , and post-hoc analysis found an increasing trend of hair growth over time that was statistically significant ( p-value < 0.0001 ) with the estimated slope of 1.406 .
RESULTS	Increased hair counts from the baseline to the end of the 26-week period were found to be strongly significant ( p-value = 0.0003 ) .
CONCLUSIONS	Albeit , sham device failure and resultant missing data from the control group , the positive trend hair growth , was observed due to the chronic use of X5hairlaser device .
CONCLUSIONS	This positive benefit while in full agreement with other low laser hair devices requires intensive further investigation .
BACKGROUND	NCT02067260 .

###24986531
OBJECTIVE	Recent preclinical work has suggested that postprandial flow of bile acids into the small intestine potentiates nutrient-induced glucagon-like peptide 1 ( GLP1 ( GCG ) ) secretion via bile acid-induced activation of the G protein-coupled receptor TGR5 in intestinal L cells .
OBJECTIVE	The notion of bile-induced GLP1 secretion combined with the findings of reduced postprandial gallbladder emptying in patients with type 2 diabetes ( T2DM ) led us to speculate whether reduced postprandial GLP1 responses in some patients with T2DM arise as a consequence of diabetic gallbladder dysmotility .
METHODS	In a randomised design , 15 patients with long-standing T2DM and 15 healthy age - , gender - and BMI-matched control subjects were studied during 75-g oral glucose tolerance test ( OGTT ) and three isocaloric ( 500kcal ) and isovolaemic ( 350ml ) liquid meals : i ) 2.5 g fat , 107g carbohydrate and 13g protein ; ii ) 10g fat , 93g carbohydrate and 11g protein ; and iii ) 40g fat , 32g carbohydrate and 3g protein .
METHODS	Basal and postprandial plasma concentrations of glucose , insulin , C-peptide , glucagon , GLP1 , glucose-dependent insulinotropic polypeptide ( GIP ) , cholecystokinin and gastrin were measured .
METHODS	Furthermore , gallbladder emptying and gastric emptying were examined .
RESULTS	Gallbladder emptying increased with increasing meal fat content , but no intergroup differences were demonstrated .
RESULTS	GIP and GLP1 responses were comparable among the groups with GIP levels being higher following high-fat meals , whereas GLP1 secretion was similar after both OGTT and meals .
CONCLUSIONS	In conclusion , patients with T2DM exhibited normal gallbladder emptying to meals with a wide range of fat content .
CONCLUSIONS	Incretin responses were similar to that in controls , and an association with postprandial gallbladder contraction could not be demonstrated .

###24861418
BACKGROUND	Deaths due to road traffic injuries , particularly motorcycle crashes , have increased rapidly in many African nations and context-specific strategies to improve preventative behaviours are needed .
BACKGROUND	Although adhering to conspicuity measures by wearing reflective safety vests is a highly effective crash prevention strategy and mandated by law among motorcycle-taxi drivers in some African countries , actual use is currently low .
BACKGROUND	We aimed to test whether eliminating cost-barriers through the provision of free reflective , fluorescent motorcycle safety vests would lead to increased utilisation among a high-risk population of motorcycle-taxi drivers in Tanzania .
METHODS	A cluster randomised controlled trial was conducted among 180 motorcycle-taxi drivers .
METHODS	Participants randomised to the intervention arm ( 90 ) received free , reflective , fluorescent vests ; participants randomised to the control arm ( 90 ) did not receive free vests .
METHODS	Participants ' use of reflective vests was then observed on city streets over a three month period and differential uptake was estimated using mixed-effects logistic regression .
RESULTS	Baseline use of reflective vests was 3.3 % in both arms .
RESULTS	Seventy-nine drivers in the intervention arm and 82 drivers in the control arm were observed during follow-up .
RESULTS	The average proportion of observations during which motorcycle drivers were using a reflective vest was 9.5 % in the intervention arm , compared to 2.0 % in the control arm ( odds ratio : 5.5 , 95 % confidence interval : 1.1-26 .9 , p-value : 0.04 ) .
CONCLUSIONS	Although distribution of free reflective vests led to a statistically significant increase in vest usage , the absolute increase was modest .
CONCLUSIONS	Additional strategies beyond removing economic barriers are important to augment adherence to road safety behaviours for injury prevention .

###24636877
BACKGROUND	Kaposi 's sarcoma ( KS ) is a common childhood cancer in places where HIV is endemic and access to antiretroviral therapy ( ART ) is delayed .
BACKGROUND	Despite this there are no randomised trials to compare and assess chemotherapeutic regimens .
METHODS	An open label , randomised trial comparing intravenous vincristine alone , vincristine and bleomycin and oral etoposide , was carried out in children with Kaposi 's sarcoma in the Queen Elizabeth Central Hospital , Blantyre , Malawi .
METHODS	HIV infected children were given ART after 2-3 courses of chemotherapy if they were not already on treatment .
METHODS	Neither HIV nor widespread KS are curable and treatment is aimed at disease reduction and improved quality of life .
METHODS	Tumour reduction was assessed by measuring the size of sentinel KS nodules and quality of life ( QoL ) by using the Lansky score .
METHODS	Follow up was until death or for one year .
RESULTS	92 children were enrolled of whom 46 % were nave to ART ; 10 ( 11 % ) were HIV negative .
RESULTS	Survival was not influenced by age or gender but was better in the oral etoposide and the vincristine and bleomycin groups .
RESULTS	P = 0.0045 .
RESULTS	The group receiving oral etoposide had a better quality of life .
RESULTS	Toxicity was not significant , and any drop in haemoglobin or white cell count could have been causally related to HIV infection rather than cytotoxic therapy .
CONCLUSIONS	Oral etoposide is a safe , effective treatment to contain KS and improve QoL which can be achieved without many visits to the hospital and intravenous injections .

###25414262
BACKGROUND	Artemisinin combination therapy effectively clears asexual malaria parasites and immature gametocytes but does not prevent posttreatment malaria transmission .
BACKGROUND	Ivermectin ( IVM ) may reduce malaria transmission by killing mosquitoes that take blood meals from IVM-treated humans .
METHODS	In this double-blind , placebo-controlled trial , 120 asymptomatic Plasmodium falciparum parasite carriers were randomized to receive artemether-lumefantrine ( AL ) plus placebo or AL plus a single or repeated dose ( 200 g/kg ) of ivermectin ( AL-IVM1 and AL-IVM2 , respectively ) .
METHODS	Mosquito membrane feeding was performed 1 , 3 , and 7 days after initiation of treatment to determine Anopheles gambiae and Anopheles funestus survival and infection rates .
RESULTS	The AL-IVM combination was well tolerated .
RESULTS	IVM resulted in a 4 - to 7-fold increased mortality in mosquitoes feeding 1 day after IVM ( P < .001 ) .
RESULTS	Day 7 IVM plasma levels were positively associated with body mass index ( r = 0.57 , P < .001 ) and were higher in female participants ( P = .003 ) , for whom An .
RESULTS	gambiae mosquito mortality was increased until 7 days after a single dose of IVM ( hazard rate ratio , 1.34 [ 95 % confidence interval , 1.07-1 .69 ] ; P = .012 ) .
RESULTS	Although we found no evidence that IVM reduced Plasmodium infection rates among surviving mosquitoes , the mosquitocidal effect of AL-IVM1 and AL-IVM2 resulted in 27 % and 35 % reductions , respectively , in estimated malaria transmission potential during the first week after initiation of treatment .
CONCLUSIONS	We conclude that IVM can be safely given in combination with AL and can reduce the likelihood of malaria transmission by reducing the life span of feeding mosquitoes .
BACKGROUND	NCT0160325 .

###24635756
OBJECTIVE	To evaluate the prevalence of respiratory impairment and dyspnea and their associations with objectively measured physical inactivity and performance-based mobility in sedentary older persons .
METHODS	Cross-sectional .
METHODS	Lifestyle Interventions and Independence for Elders Study .
METHODS	Community-dwelling older persons ( n = 1,635 , mean age 78.9 ) who reported being sedentary ( < 20 min/wk of regular physical activity and < 125 min/wk of moderate physical activity in past month ) .
METHODS	Respiratory impairment was defined as low ventilatory capacity ( forced expiratory volume in 1 second less than lower limit of normal ( LLN ) ) and respiratory muscle weakness ( maximal inspiratory pressure < LLN ) .
METHODS	Dyspnea was defined as moderate to severe ratings on the modified Borg index , immediately after a 400-m walk test ( 400-MWT ) .
METHODS	Physical inactivity was defined according to high sedentary time as the highest quartile of participants with accelerometry-measured activity of < 100 counts/min .
METHODS	Performance-based mobility was evaluated using the Short Physical Performance Battery ( 7 defined as moderate to severe mobility impairment ) and 400-MWT gait speed ( < 0.8 m/s defined as slow ) .
RESULTS	Prevalence rates were 17.7 % for low ventilatory capacity , 14.7 % for respiratory muscle weakness , 31.6 % for dyspnea , 44.7 % for moderate to severe mobility impairment and 43.6 % for slow gait speed .
RESULTS	Significant associations were found between low ventilatory capacity and slow gait speed ( adjusted odds ratio ( aOR ) = 1.41 , 95 % confidence interval ( CI ) = 1.03-1 .92 ) , between respiratory muscle weakness and moderate to severe mobility impairment ( aOR = 1.42 , 95 % CI = 1.03-1 .95 ) , and between dyspnea and high sedentary time ( aOR = 1.98 , 95 % CI = 1.28-3 .06 ) and slow gait speed ( aOR = 1.70 , 95 % CI = 1.22-2 .38 ) .
CONCLUSIONS	Respiratory impairment and dyspnea are prevalent in sedentary older persons and are associated with objectively measured physical inactivity and poor performance-based mobility .
CONCLUSIONS	Because they are modifiable , respiratory impairment and dyspnea should be considered in the evaluation of sedentary older persons .

###24525469
BACKGROUND	The Single-Tablet Regimen ( STaR ) study ( GS-US-264-0110 ) is a 96-week phase 3b study evaluating the safety and efficacy of 2 single-tablet regimens , rilpivirine/emtricitabine/tenofovir DF ( RPV/FTC/TDF ) , and efavirenz/emtricitabine/tenofovir DF ( EFV/FTC/TDF ) in treatment-naive HIV-1-infected subjects .
METHODS	Genotypic analyses ( population sequencing ) of HIV-1 protease and reverse transcriptase were performed at screening ; subjects with pre-existing resistance to study drugs were excluded .
METHODS	The primary protocol-defined resistance analysis population ( RAP ) had genotypic/phenotypic analyses at failure and baseline for protease and reverse transcriptase .
RESULTS	At week 48 , the primary RAP included 20/394 subjects ( 5.1 % ) receiving RPV/FTC/TDF and 7/392 subjects ( 1.8 % ) receiving EFV/FTC/TDF .
RESULTS	In the RPV/FTC/TDF arm , isolates from 17/394 subjects ( 4.3 % ) developed nonnucleoside reverse transcriptase inhibitor ( NNRTI ) and/or nucleoside reverse transcriptase inhibitor ( NRTI ) resistance mutations , and 16/17 isolates had both NNRTI and NRTI resistance mutations .
RESULTS	In the EFV/FTC/TDF arm , isolates from 3/392 subjects ( 0.8 % ) developed NNRTI and/or NRTI resistance mutations .
RESULTS	When stratified by baseline viral load of either 100,000 or > 100,000 copies/mL , 5/260 ( 1.9 % ) versus 12/134 ( 9.0 % ) RPV/FTC/TDF-treated subjects and 2/250 ( 0.8 % ) versus 1/142 ( 0.7 % ) EFV/FTC/TDF-treated subjects developed resistant isolates , respectively .
RESULTS	The presence of pre-existing NRTI - and NNRTI-associated resistance mutations not excluded at screening ( not related to study drugs ) did not impact treatment response to either regimen .
CONCLUSIONS	Among subjects in the primary RAP , resistance development to RPV/FTC/TDF consisted of NNRTI and NRTI mutations and was more frequent than resistance development to EFV/FTC/TDF .
CONCLUSIONS	In subjects with baseline viral load 100,000 copies/mL , resistance development was low ( < 2 % ) for both RPV/FTC/TDF and EFV/FTC/TDF arms and less frequent compared with subjects with baseline viral load > 100,000 copies/mL , for RPV/FTC/TDF .

###25262435
BACKGROUND	The adverse health effects of insufficient physical activity ( PA ) result in high costs to society .
BACKGROUND	The economic burden of insufficient PA , which increases in our aging population , stresses the urgency for cost-effective interventions to promote PA among older adults .
BACKGROUND	The current study provides insight in the cost-effectiveness and cost-utility of different versions of a tailored PA intervention ( Active Plus ) among adults aged over fifty .
METHODS	The intervention conditions ( i.e. print-delivered basic ( PB ; N = 439 ) , print-delivered environmental ( PE ; N = 435 ) , Web-based basic ( WB ; N = 423 ) , Web-based environmental ( WE ; N = 432 ) ) and a waiting-list control group were studied in a clustered randomized controlled trial .
METHODS	Intervention costs were registered during the trial .
METHODS	Health care costs , participant costs and productivity losses were identified and compared with the intervention effects on PA ( in MET-hours per week ) and quality-adjusted life years ( QALYs ) 12months after the start of the intervention .
METHODS	Cost-effectiveness ratios ( ICERs ) and cost-utility ratios ( ICURs ) were calculated per intervention condition .
METHODS	Non-parametric bootstrapping techniques and sensitivity analyses were performed to account for uncertainty .
RESULTS	As a whole ( i.e. the four intervention conditions together ) the Active Plus intervention was found to be cost-effective .
RESULTS	The PB-intervention ( ICER = -55 / MET-hour ) , PE-intervention ( ICER = -94 / MET-hour ) and the WE-intervention ( ICER = -139 / MET-hour ) all resulted in higher effects on PA and lower societal costs than the control group .
RESULTS	With regard to QALYs , the PB-intervention ( ICUR = 38,120 / QALY ) , the PE-intervention ( ICUR = 405,892 / QALY ) and the WE-intervention ( ICUR = -47,293 / QALY ) were found to be cost-effective when considering a willingness-to-pay threshold of 20,000 / QALY .
RESULTS	In most cases PE had the highest probability to be cost-effective .
CONCLUSIONS	The Active Plus intervention was found to be a cost-effective manner to increase PA in a population aged over fifty when compared to no-intervention .
CONCLUSIONS	The tailored Active Plus intervention delivered through printed material and with additional environmental information ( PE ) turned out to be the most cost-effective intervention condition as confirmed by the different sensitivity analyses .
CONCLUSIONS	By increasing PA at relatively low costs , the Active Plus intervention can contribute to a better public health .
BACKGROUND	Dutch Trial Register : NTR2297 .

###25158837
OBJECTIVE	The effectiveness of acupuncture in relieving acute postoperative pain is still controversial .
OBJECTIVE	This patient-evaluator blinded and sham auricular acupuncture ( AA ) - controlled study tested whether acupuncture is effective in controlling acute postoperative pain after total knee arthroplasty .
METHODS	Patients were randomly assigned to receive true acupuncture ( knee , scalp , and AA ) or sham AA .
METHODS	All procedures were conducted under general anesthesia , and the AA needles were retained in situ for 3 days .
METHODS	Postoperative pain was managed with intravenous fentanyl using a patient-controlled analgesia pump .
METHODS	The amount of postoperative fentanyl required , the time to the first fentanyl request , pain intensity on a 100-mm visual analog scale , incidence of analgesia-related adverse effects , and success of patients ' blinding were recorded .
RESULTS	This study comprised 60 patients ( 30 in the study group and 30 in the control group ) .
RESULTS	The fentanyl requirement via patient-controlled analgesia in the study group was lower [ mean ( SD ) , 620.7 ( 258.2 ) vs 868.6 ( 319.3 ) g ; P = 0.002 ) .
RESULTS	The time to first request for fentanyl was longer in the study group .
RESULTS	Pain intensity on a 100-mm visual analog scale was lower in the study group in the first 24 hours after the operation .
RESULTS	The incidence of analgesia-related adverse effects of nausea and vomiting was lower in the study group .
RESULTS	The success of blinding was not significantly different between the 2 groups ( P = 0.731 ) .
CONCLUSIONS	The data obtained from this clinical trial demonstrate the potential advantages of using acupuncture for postoperative pain control after total knee arthroplasty .

###25236582
BACKGROUND	Exercise capacity , which is predictive of all-cause mortality and cardiovascular disease risk , is reduced significantly in patients with non-dialysis-dependent chronic kidney disease .
BACKGROUND	This pilot study examined the effect of moderate-intensity exercise training on kidney function and indexes of cardiovascular risk in patients with progressive chronic kidney disease stages 3 to4 .
METHODS	Single-blind , randomized , controlled , parallel trial .
METHODS	20 patients ( aged 18-80 years ; 17 men ) randomly assigned to rehabilitation ( n = 10 ) or usual care ( n = 10 ) .
METHODS	Participants were included if they were 18 years or older and had evidence of rate of decline in creatinine-based estimated glomerular filtration rate ( eGFRcr ) 2.9 mL/min/1 .73 m ( 2 ) per year for 12 months preintervention .
METHODS	Patients were excluded if they had unstable medical conditions or had recently started regular exercise .
METHODS	The rehabilitation group received resistance and aerobic training ( 3 days per week ) for a 12-month period .
METHODS	The usual care group received standard care .
RESULTS	Kidney function assessed by comparing mean rate of change in eGFRcr ( mL/min/1 .73 m ( 2 ) per year ) from a 12-month preintervention period against the 12-month intervention period .
RESULTS	Pulse wave velocity ( PWV ) , peak oxygen uptake ( Vo2peak ) , and waist circumference assessed at 0 , 6 , and 12 months .
METHODS	eGFR assessed using creatinine , cystatin C ( eGFRcys ) , and a combination of both values ( eGFRcr-cys ) .
RESULTS	18 participants ( rehabilitation , 8 ; usual care , 10 ) completed the study .
RESULTS	A significant mean difference in rate of change in eGFRcr ( +7.83.0 [ 95 % CI , 1.1-13 .5 ] mL/min/1 .73 m ( 2 ) per year ; P = 0.02 ) was observed between the rehabilitation and usual care groups , with the rehabilitation group demonstrating a slower decline .
RESULTS	No significant between-group mean differences existed in absolute eGFRcr , eGFRcr-cys , or eGFRcys at 12 months of study intervention .
RESULTS	Significant between-group mean differences existed in PWV ( -2.30 [ 95 % CI,-3 .02 to-1 .59 ] m/s ) , waist circumference ( -7.112.8 [ 95 % CI,-12 .4 to-3 .2 ] cm ) , and Vo2peak ( 5.7 [ 95 % CI , 1.34-10 .10 ] mL/kg/min ) .
RESULTS	Change in eGFRcr was correlated inversely with PWV ( r = -0.5 ; P = 0.04 ) at 12 months .
CONCLUSIONS	Small sample size , inconsistency between primary and secondary measures of kidney function .
CONCLUSIONS	The effect of a 1-year exercise intervention on progression of kidney disease is inconclusive .
CONCLUSIONS	A larger study with longer follow-up may be necessary .

###24267254
METHODS	A total of 102 patients were randomized to either mono-therapy with simvastatin ( 40 mg daily ) or triple-therapy with simvastatin ( 40 mg daily ) , extended-release niacin ( 1500 mg daily ) , and ezetimibe ( 10 mg daily ) .
METHODS	MRI was performed at baseline and 6 , 12 , and 24 months .
METHODS	SFA wall , lumen , and total vessel volumes were quantified .
METHODS	MRI-derived SFA parameters and lipids were analyzed with multilevel models and nonparametric tests , respectively .
RESULTS	Baseline characteristics did not differ between mono and triple-therapy groups , except for ethnicity ( p = 0.02 ) .
RESULTS	SFA wall , lumen , and total vessel volumes increased non-significantly for both groups between baseline and 24-months .
RESULTS	Non-high-density lipoprotein cholesterol was significantly reduced at 12 months with triple-therapy compared with mono-therapy ( p = 0.01 ) .
CONCLUSIONS	No significant differences were observed between mono-therapy using simvastatin and triple-therapy with simvastatin , extended-release niacin , and ezetimibe for 24-month changes in SFA wall , lumen , and total vessel volumes .
BACKGROUND	NCT00687076 ; Link : http://clinicaltrials.gov/ct2/show/NCT00687076 .

###24687927
OBJECTIVE	We examined the prognostic impact of specific KRAS mutations in patients with stage III colon adenocarcinoma receiving adjuvant FOLFOX alone or combined with cetuximab in a phase III trial ( N0147 ) .
OBJECTIVE	Analysis was restricted to BRAF-wild-type tumors , because BRAF mutation was associated with poor prognosis , and BRAF and KRAS mutations are mutually exclusive .
METHODS	The seven most common KRAS mutations in codon 12 and codon 13 were examined in 2,478 BRAF-wild-type tumors .
METHODS	Because KRAS mutations in codon 12 ( n = 779 ) or 13 ( n = 220 ) were not predictive of adjuvant cetuximab benefit , study arms were pooled for analysis .
METHODS	Disease-free survival ( DFS ) was evaluated by HRs using Cox models .
RESULTS	KRAS mutations in codon 12 ( multivariate HR , 1.52 ; 95 % confidence interval , CI , 1.28-1 .80 ; P < 0.0001 ) or codon 13 ( multivariate HR , 1.36 ; 95 % CI , 1.04-1 .77 ; P = 0.0248 ) were significantly associated with shorter DFS compared with patients with wild-type KRAS/BRAF tumors , independent of covariates .
RESULTS	KRAS codon 12 mutations were independently associated with proficient mismatch repair ( P < 0.0001 ) , proximal tumor site ( P < 0.0001 ) , low grade , age , and sex , whereas codon 13 mutations were associated with proximal site ( P < 0.0001 ) .
CONCLUSIONS	KRAS mutations in either codon 12 or 13 are associated with inferior survival in patients with resected stage III colon cancer .
CONCLUSIONS	These data highlight the importance of accurate molecular characterization and the significant role of KRAS mutations in both codons in the progression of this malignancy in the adjuvant setting .
CONCLUSIONS	Clin Cancer Res ; 20 ( 11 ) ; 3033-43 .2014 AACR .

###24881803
BACKGROUND	Administration of vaccines by needle-free technology such as jet injection might offer an alternative to needles and syringes that avoids the issue of needle phobia and the risk of needle-stick injury .
BACKGROUND	We aimed to assess the immunogenicity and safety of trivalent influenza vaccine given by needle-free jet injector compared with needle and syringe .
METHODS	For this randomised , comparator-controlled trial , we randomly assigned ( 1:1 ) healthy adults ( aged 18-64 years ) who attended one of four employee health clinics in the University of Colorado health system , with stratification by site , to receive one dose of the trivalent inactivated influenza vaccine Afluria given either intramuscularly with a needle-free jet injector ( Stratis ; PharmaJet , Golden , CO , USA ) or with needle and syringe .
METHODS	Randomisation was done with a computer-generated randomisation schedule with a block size of 100 .
METHODS	Because of the nature of the study , masking of participants was not possible .
METHODS	Immunogenicity was assessed by measurement of the hemagglutination inhibition antibody titres in serum for the three viral strains included in the vaccine .
METHODS	We included six coprimary endpoints : three strain-specific geometric mean titre ratios and the absolute differences in three strain-specific seroconversion rates .
METHODS	The immune response of the jet injector group was regarded as non-inferior to that of the needle and syringe group if both the upper bound of each of the three 95 % CIs for the strain-specific geometric mean titre ratios was 1.5 or less , and the upper bound of the three 95 % CIs for the strain-specific seroconversion rate differences was less than 10 percentage points .
METHODS	We used t test for group comparison .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01688921 .
RESULTS	During the 2012-13 influenza season of the northern hemisphere , we allocated 1250 participants to receive vaccination by needle-free jet injector ( n = 627 ) or needle and syringe ( n = 623 ) .
RESULTS	In the intention-to-treat immunogenicity population , all participants with two serum samples were included ( 575 in the jet injector group and 574 in the needle and syringe group ) .
RESULTS	The immune response to Afluria when given by needle-free jet injector met the criteria for non-inferiority for all six coprimary endpoints .
RESULTS	The jet injector group met the geometric mean titre criterion for non-inferiority for the A/H1N1 , A/H3N2 , and B strains ( upper bound of the 95 % CI for the geometric mean titre ratios were 110 for A/H1N1 , 117 for A/H3N2 , and 104 for B strains ) .
RESULTS	The jet injector group met the seroconversion rate criterion for non-inferiority for the A/H1N1 , A/H3N2 , and B strains ( upper bound of the 95 % CI of the seroconversion rate differences were 60 % for A/H1N1 , 70 % for A/H3N2 , and 57 % for B strains ) .
RESULTS	We recorded serious adverse events in three participants , none of which were study related .
CONCLUSIONS	The immune response to influenza vaccine given with the jet injector device was non-inferior to the immune response to influenza vaccine given with needle and syringe .
CONCLUSIONS	The device had a clinically acceptable safety profile , but was associated with a higher frequency of local injection site reactions than was the use of needle and syringe .
CONCLUSIONS	The Stratis needle-free jet injector device could be used as an alternative method of administration of Afluria trivalent influenza vaccine .
BACKGROUND	Biomedical Advanced Research and Development Authority ( BARDA ) , PATH , bioCSL , and PharmaJet .

###25762749
BACKGROUND	Preclinical and human laboratory research suggests that ( a ) progesterone may decrease drug reward , craving , and smoking behavior , and ( b ) estradiol may enhance drug reward and smoking behavior .
BACKGROUND	A modest majority of treatment research examining the relationship between menstrual cycle phase and outcomes suggests that the luteal menstrual phase , with its uniquely higher progesterone levels , is associated with better cessation outcomes .
BACKGROUND	However , no studies to date have examined the effects of naturally occurring variation in progesterone and estradiol levels on medication-assisted smoking cessation .
BACKGROUND	The present study sought to fill this notable gap in the treatment literature .
METHODS	Weekly plasma progesterone and estradiol levels were obtained from nicotine-dependent female smokers enrolled in a 4-week cessation trial .
METHODS	Participants ( N = 108 ) were randomized to receive a 4-week course of either varenicline ( VAR ) tablets and placebo patches or placebo tablets and nicotine patches .
METHODS	Plasma samples were obtained 1 week before their cessation attempt and weekly during medication administration .
METHODS	Abstinence was assessed weekly .
RESULTS	Weekly hormone data replicated commonly observed menstrual cycle patterns of progesterone and estradiol levels .
RESULTS	Importantly , increases in progesterone level were associated with a 23 % increase in the odds for being abstinent within each week of treatment .
RESULTS	This effect was driven primarily by nicotine patch-treated versus VAR-treated females .
CONCLUSIONS	This study was the first to identify an association between progesterone level ( increasing ) and abstinence outcomes in free-cycling women smokers who participated in a medication-based treatment .
CONCLUSIONS	Furthermore , the potential benefits of progesterone may vary across different pharmacotherapies .
CONCLUSIONS	Implications of these findings for smoking cessation intervention are discussed .

###25113095
OBJECTIVE	The purpose of the present study was to investigate the effect of high-dose inhaled terbutaline on muscle strength , maximal sprinting , and time-trial performance in trained men .
METHODS	Nine non-asthmatic males with a VSOmax of 58.9 3.1 ml min ( -1 ) kg ( -1 ) ( mean SEM ) participated in a double-blinded randomized crossover study .
METHODS	After administration of inhaled terbutaline ( 30 0.5 mg ) or placebo , subjects ' maximal voluntary isometric contraction ( MVC ) of m.quadriceps was measured .
METHODS	After MVC , subjects performed a 30-s Wingate test .
METHODS	Sixty minutes following the Wingate test , subjects exercised for 10 min at 80 % of VSOmax and completed a 100-kcal time trial .
METHODS	Aerobic contribution was determined during the Wingate test by indirect calorimetry .
METHODS	Furthermore , plasma terbutaline , lactate , glucose , and K ( + ) were measured .
RESULTS	Inhalation of 15 mg terbutaline resulted in systemic concentrations of terbutaline of 23.6 1.1 ng ml ( -1 ) 30 min after administration , and elevated plasma lactate ( P = 0.001 ) and glucose ( P = 0.007 ) .
RESULTS	MVC was higher for terbutaline than placebo ( 738 64 vs. 681 68 N ) ( P = 0.007 ) .
RESULTS	In addition , Wingate peak power and mean power were 2.2 0.8 ( P = 0.019 ) and 3.3 1.0 % ( P = 0.009 ) higher for terbutaline than placebo .
RESULTS	Net accumulation of plasma lactate was higher ( P = 0.003 ) for terbutaline than placebo during the Wingate test , whereas [ Formula : see text ] above baseline was unchanged by terbutaline ( P = 0.882 ) .
RESULTS	Time-trial performance was not different between treatments ( P = 0.236 ) .
CONCLUSIONS	High-dose inhaled terbutaline elicits a systemic response that enhances muscle strength and sprint performance .
CONCLUSIONS	High-dose terbutaline should therefore continue to be restricted in competitive sport .

###25928298
BACKGROUND	Fewer than one in 10 adolescents with substance use disorders ( ASUDs ) will receive specialty treatment , and even fewer will receive treatment designated as evidence-based practice ( EBP ) .
BACKGROUND	Traditional efforts to increase the utilization of EBP by ASUDs typically focus on practitioners-either in substance use clinics or allied health settings .
BACKGROUND	Direct-to-consumer ( DTC ) marketing that directly targets parents of ASUDs represents a potentially complementary paradigm that has yet to be evaluated .
BACKGROUND	The current study is the first to evaluate the relevance of a well-established marketing framework ( the Marketing Mix ) and measurement approach ( measurement of perceived service quality [ PSQ ] ) with parents of ASUDs in need of treatment .
METHODS	A mixed-methods design is employed across three study phases , consistent with well-established methods used in the field of marketing science .
METHODS	Phase 1 consists of formative qualitative research with parents ( and a supplementary sample of adolescents ) in order to evaluate and potentially adapt a conceptual framework ( Marketing Mix ) and measure of PSQ .
METHODS	Phase 2 is a targeted survey of ASUD parents to elucidate their marketing preferences , using the adapted Marketing Mix framework , and to establish the psychometric properties of the PSQ measure .
METHODS	The survey will also gather data on parents ' preferences for different targeted marketing messages .
METHODS	Phase 3 is a two-group randomized controlled trial comparing the effectiveness of targeted marketing messages versus standard clinical information .
METHODS	Key outcomes will include parents ' ratings of PSQ ( using the new measure ) , behavioral intentions to seek out information about EBP , and actual information-seeking behavior .
CONCLUSIONS	The current study will inform the field whether a well-established marketing framework and measurement approach can be used to increase demand for EBP among parents of ASUDs .
CONCLUSIONS	Results of this study will have the potential to immediately inform DTC marketing efforts by professional organizations , federal agencies , clinicians , and clinical researchers .

###24636286
OBJECTIVE	To evaluate the efficacy and safety of entecavir maleate ( ETV ) versus ETV in Chinese patients with hepatitis B e antigen ( HBeAg ) - positive chronic hepatitis B ( CHB ) .
METHODS	The patient population of this previously published randomized , double-blind , double-dummy , controlled , multicenter study was expanded by patients in the 0.5 mg/day ETV maleate group ( total n = 110 ) and patients in the 0.5 mg/day ETV group ( total n = 108 ) .
METHODS	At treatment weeks 12 , 24 and 48 , hepatitis B virus ( HBV ) DNA levels were measured by the Roche Cobas Ampliprep/Cobas Taqman PCR assay .
METHODS	Adverse events ( AE ) were recorded .
RESULTS	As in the original analysis , the two treatment groups showed similar characteristics at baseline .
RESULTS	In addition , the results for the all therapeutic effects showed identical trends to the results obtained in the original analysis , including the statistically similar effects of ETV and ETV maleate treatment-induced decreases in mean HBV DNA level at weeks 12 , 24 , and 48 ( ETV : by 4.28 , 5.00 , and 5.53 log10 IU/ml vs. ETV maleate : by 4.46 , 4.99 , and 5.51 log10 IU/ml , respectively ; all vs. baseline P more than 0.05 ) , achievement of undetectable levels of serum HBV DNA ( less than 20 IU/ml ) at week 48 ( ETV : 38.18 % vs. ETV maleate : 35.19 % ; P more than 0.05 ) , HBeAg loss rates at week 48 ( ETV : 10.91 % vs. ETV maleate : 12.96 % ; P more than 0.05 ) , HBeAg seroconversion rates at week 48 ( ETV : 7.77 % vs. ETV maleate : 10.38 % ; P more than 0.05 ) , normalization of alanine aminotransferase at week 48 ( ETV : 75.47 % vs. ETV maleate : 82.86 % ; P more than 0.05 ) , and overall incidence of AE ( ETV : 18.02 % vs. ETV maleate : 17.43 % ; P more than 0.05 ) .
CONCLUSIONS	Performing analysis of the therapeutic efficacies of entecavir maleate versus entecavir with a larger study population confirmed our original findings of similar efficacy and safety profiles for these two drugs in patients with HBeAg-positive CHB .

###24642073
OBJECTIVE	To examine potential mechanisms underlying nicotine 's effects on male sexual arousal by exploring the mediating role of heart rate variability ( HRV ) .
METHODS	The sample comprised 22 healthy , nicotine-nave men ( mean age = 20.91 years ; standard deviation = 2.43 ) .
METHODS	Data were taken from a double-blind , randomized , placebo-controlled , crossover trial previously completed and published elsewhere .
METHODS	During each laboratory visit , time-domain parameters of HRV ( standard deviation of normal-to-normal [ NN ] intervals , square root of the mean squared difference of successive NN intervals , and percent of NN intervals for which successive heartbeat intervals differed by at least 50 ms [ pNN50 ] ) along with the objective ( via penile plethysmography ) and subjective indices of sexual arousal were assessed .
RESULTS	Acute nicotine ingestion ( compared with placebo ) was associated with dysregulated sympathovagal balance , which in turn was related to relatively reduced erectile tumescence .
RESULTS	HRV did not mediate relations between nicotine intake and self-reported indices of sexual arousal .
CONCLUSIONS	HRV mediated the association between nicotine ingestion and erectile capacity .
CONCLUSIONS	Findings suggest that dysfunctional cardiac autonomic tone may be an underlying mechanism by which nicotine exerts its deleterious effects on erectile health .

###25632203
OBJECTIVE	To study the frequency of vitamin D deficiency in patients with hepatitis C virus ( HCV ) infection and to evaluate the role of vitamin D supplementation in improving antiviral therapy .
METHODS	Sixty-six children aged from 7-14 years ( mean SD , 11.172.293 ) diagnosed with HCV infection were matched to 28 healthy controls .
METHODS	Serum levels of 25 ( OH ) D3 , calcium , phosphorus , alkaline phosphatase and plasma level of parathormone were measured .
METHODS	Quantitative PCR for HCV was performed Bone density was determined by dual energy X-ray absorptiometry .
METHODS	All cases received conventional therapy , and only 33 patients received vitamin D supplementation .
RESULTS	Children with HCV showed significantly increased levels of HCV RNA ( P < 0.001 ) , parathormone ( P < 0.01 ) and decreased vitamin D levels ( P < 0.05 ) ( 33.3 % deficient and 43.3 % insufficient ) compared with controls .
RESULTS	Abnormal bone status ( Z score -1.980.75 ) was found in ribs , L-spine , pelvis and total body .
RESULTS	Cases treated with vitamin D showed significant higher early ( P < 0.04 ) and sustained ( P < 0.05 ) virological response .
RESULTS	There was a high frequency of vitamin D deficiency among the Egyptian HCV children , with significant decrease in bone density .
RESULTS	The vitamin D level should be assessed before the start of antiviral treatment with the correction of any detected deficiency .
CONCLUSIONS	Adding vitamin D to conventional Peg/RBV therapy significantly improved the virological response and helped to prevent the risk of emerging bone fragility .

###25195371
OBJECTIVE	To investigate the effects of the plasma containing Qianlongtong Capsule ( QLT ) - containing plasma on the expression of the Smad4 gene in prostate stromal cells in vitro and provide some experimental evidence for the treatment of benign prostatic hyperplasia ( BPH ) with Chinese medicinal compound .
METHODS	Fifteen cases of BPH were equally randomized to three groups to be treated with QLT at a high dose ( 6 capsules once ) , a medium dose ( 3 capsules once ) , and a low dose ( 1.5 capsules once ) , tid , for 7 days consecutively .
METHODS	QLT-containing plasma was collected from the patients .
METHODS	Prostate stromal cells were identified by immunofluorescence when they became monolayered and cultured in the QLT-containing plasma for 24 hours , followed by detection of the expression of the Smad4 gene by real-time quantitative PCR and that of the Smad4 protein by Western blot .
RESULTS	After treatment with the QLT-containing plasma , the expression of the Smad4 gene in the stromal cells was significantly increased in a dose-dependent manner as compared with the blank control and no-QLT groups ( P < 0.01 ) .
RESULTS	The expression of the Smad4 protein was also markedly elevated after treatment .
RESULTS	The differences were statistically significant between the blank control and medium-dose groups ( P < 0.01 ) , low-dose and medium-dose groups ( P < 0.05 ) , and high-dose and the other groups ( P < 0.01 ) , but not between the blank control and low-dose groups ( P > 0.05 ) .
CONCLUSIONS	QLT-containing plasma could inhibit the proliferation and improve the apoptotic index of prostate stromal cells in vitro , which was related to the elevation of the mRNA and protein expressions of Smad4 .

###24358625
OBJECTIVE	This study evaluated in-office balloon dilation of maxillary sinus ostia and ethmoid infundibula to treat chronic rhinosinusitis ( CRS ) and recurrent acute rhinosinusitis ( RARS ) .
METHODS	Seventy-four patients with disease in the maxillary and anterior ethmoid sinuses on computed tomography were prospectively enrolled across 12 study centers .
METHODS	All procedures were performed in the office .
METHODS	The primary outcomes were clinical effectiveness and health-care utilization at 1 year , measured by the validated surveys Sino-Nasal Outcome Test ( SNOT-20 ) and Rhinosinusitis Symptom Inventory ( RSI ) .
RESULTS	Dilation was successful in 69 patients ( 93.2 % ) , and the average periprocedural pain level was 3.2 ( scale of 0 to 10 ) .
RESULTS	The mean improvement on the SNOT-20 at 1 year was clinically and statistically significant ( p < 0.0001 ) , with no significant difference between the CRS and RARS patient outcomes .
RESULTS	The treatment effect was the same in the CRS and RARS subgroups and was either `` moderate '' or `` large '' for 10 of 12 symptoms .
RESULTS	The mean numbers of antibiotic courses ( p < or = 0.001 ) , sinus-related physician visits ( p < 0.0001 ) , and number of acute sinus infections ( p < 0.001 ) decreased significantly in both subgroups .
RESULTS	There were no serious device-related adverse events , and the rate of revision surgery was 5.8 % .
CONCLUSIONS	Stand-alone balloon dilation of the maxillary sinus ostia and ethmoid infundibula performed in the office is well tolerated and effectively treats both CRS and RARS .

###25149657
OBJECTIVE	This study investigated the effect of the knee position during wound closure on early knee function recovery after total knee arthroplasty ( TKA ) .
METHODS	This study included 80 primary total knee arthroplasties due to osteoarthritis .
METHODS	The patients were randomized according to the type of wound closure : extension group for full extension and flexion group for 90 flexion .
METHODS	The incision of articular capsule was marked for precise wound alignment .
METHODS	In the flexion group , the knee was kept in high flexion for 1 to 2 min after wound closure .
METHODS	The two groups were treated with the same postoperative rehabilitation exercises .
METHODS	The range of motion ( ROM ) , visual analogue scale ( VAS ) score of anterior knee pain , Knee Society Score ( KSS ) and postoperative complications were assessed at 6 weeks , 3 months and 6 months , postoperatively .
RESULTS	At 6 weeks and 3 months postoperatively , the ROM in flexion group was 98.9510.33 and 110.054.93 respectively , with 87.628.92 and 95.626.51 in extension group , respectively ; The VAS score of anterior knee pain in flexion group was 2.021.38 and 2.210.87 , respectively , with 2.571.07 and 2.870.83 in extension group , respectively .
RESULTS	The ROM and VAS pain score of the two groups were significantly different at these two time points , with no significant difference at 6 months postoperatively .
RESULTS	The two groups were not significantly different in KSS , and no apparent complication was observed at three time points .
CONCLUSIONS	Marking the articular capsule incision , wound closure in flexion and high flexion after wound closure can effectively decrease anterior knee pain after TKA and promote the early recovery of ROM .

###25022840
BACKGROUND	The live attenuated 17DD Yellow Fever vaccine is one of the most successful prophylactic interventions for controlling disease expansion ever designed and utilized in larger scale .
BACKGROUND	However , increase on worldwide vaccine demands and manufacturing restrictions urge for more detailed dose sparing studies .
BACKGROUND	The establishment of complementary biomarkers in addition to PRNT and Viremia could support a secure decision-making regarding the use of 17DD YF vaccine subdoses .
BACKGROUND	The present work aimed at comparing the serum chemokine and cytokine kinetics triggered by five subdoses of 17DD YF Vaccine .
METHODS	Neutralizing antibody titers , viremia , cytokines and chemokines were tested on blood samples obtained from eligible primary vaccinees .
CONCLUSIONS	The results demonstrated that a fifty-fold lower dose of 17DD-YF vaccine ( 587 IU ) is able to trigger similar immunogenicity , as evidenced by significant titers of anti-YF PRNT .
CONCLUSIONS	However , only subdoses as low as 3,013 IU elicit viremia kinetics with an early peak at five days after primary vaccination equivalent to the current dose ( 27,476 IU ) , while other subdoses show a distinct , lower in magnitude and later peak at day 6 post-vaccination .
CONCLUSIONS	Although the subdose of 587 IU is able to trigger equivalent kinetics of IL-8 / CXCL-8 and MCP-1 / CCL-2 , only the subdose of 3,013 IU is able to trigger similar kinetics of MIG/CXCL -9 , pro-inflammatory ( TNF , IFN - and IL-2 ) and modulatory cytokines ( IL-5 and IL-10 ) .
CONCLUSIONS	The analysis of serum biomarkers IFN - and IL-10 , in association to PRNT and viremia , support the recommendation of use of a ten-fold lower subdose ( 3,013 IU ) of 17DD-YF vaccine .

###24701585
OBJECTIVE	To compare the effects of different anesthesia techniques on tourniquet-related ischemia-reperfusion by measuring the levels of malondialdehyde ( MDA ) , ischemia-modified albumin ( IMA ) and neuromuscular side effects .
METHODS	Sixty ASAI-II patients undergoing arthroscopic knee surgery were randomised to three groups .
METHODS	In Group S , intrathecal anesthesia was administered using levobupivacaine .
METHODS	Anesthesia was induced and maintained with sevoflurane in Group I and TIVA with propofol in Group T. Blood samples were obtained before the induction of anesthesia ( t1 ) , 30 min after tourniquet inflation ( t2 ) , immediately before ( t3 ) , and 5 min ( t4 ) , 15 min ( t5 ) , 30 min ( t 6 ) , 1 h ( t7 ) , 2 h ( t8 ) , and 6 h ( t9 ) after tourniquet release .
RESULTS	MDA and IMA levels increased significantly compared with baseline values in Group S at t2-t 9 and t2-t7 .
RESULTS	MDA levels in Group T and Group I were significantly lower than those in Group S at t2-t8 and t2-t9 .
RESULTS	IMA levels in Group T were significantly lower than those in Group S at t2-t7 .
RESULTS	Postoperatively , a temporary 1/5 loss of strength in dorsiflexion of the ankle was observed in 3 patients in Group S and 1 in Group I.
CONCLUSIONS	TIVA with propofol can make a positive contribution in tourniquet-related ischemia-reperfusion .

###24249851
OBJECTIVE	To determine the amount and type of feedback needed to improve pharmacy students ' problem-solving skills using team-based learning ( TBL ) and a problem-solving rubric .
METHODS	A problem-solving rubric was developed to assess the ability of pharmacy students ' to prioritize , organize , and defend the best and alternative options on TBL cases The study involved 3 groups of pharmacy students : second-year students in a cardiology class who received no feedback ( control group ) , third-year students in an endocrinology class who received written feedback only , and third-year students in an endocrinology class who received written and verbal feedback .
METHODS	Students worked in groups on all TBL cases except the first and last one ( beginning and end of course ) , which students completed independently as it served as a pretest and posttest .
RESULTS	Significant improvements were seen in the ability of the third-year students who received verbal and written feedback to prioritize the information presented in the case and in their total score on the problem-solving rubric .
CONCLUSIONS	Providing pharmacy students with written and verbal explanations may help them improve their problem-solving skills overall .
CONCLUSIONS	During verbal feedback , faculty members can provide more examples of how to improve and can field questions if needed .

###24646101
BACKGROUND	In vitro and animal studies have reported conflicting results regarding an independent role for FSH in the regulation of bone turnover .
OBJECTIVE	Our objective was to test the hypothesis that suppressing serum FSH while holding serum gonadal steroid levels stable in the eugonadal range will affect biochemical markers of bone metabolism in healthy men .
METHODS	Eugonadal men aged 20 to 50 years participated in this randomized controlled trial at a tertiary care academic teaching hospital .
METHODS	Participants received monthly GnRH analog injections to suppress FSH secretion plus daily topical testosterone gel in prespecified doses ( intervention group ) .
METHODS	Controls received matching placebos ( control group ) .
METHODS	Subjects in the intervention group were individually matched with subjects in the control group to ensure that the mean testosterone and estradiol levels ( measured every 4 weeks during the 16-week study period ) in the 2 groups were similar .
METHODS	Biochemical markers of bone resorption ( serum N-terminal telopeptide and C-terminal telopeptide ) , bone formation ( serum osteocalcin ) , and FSH were measured at baseline and after 16 weeks of treatment .
RESULTS	Serum FSH declined by 2 % in the control group and by 60 % in the intervention group ( P < .0001 for the between-group difference ) .
RESULTS	Despite the substantial suppression of serum FSH in the intervention group , serum N-terminal telopeptide , C-terminal telopeptide , and osteocalcin did not change in the intervention group , nor were any between-group differences observed .
CONCLUSIONS	When gonadal steroid levels are held constant , short-to midterm suppression of FSH does not affect bone turnover in men .
CONCLUSIONS	FSH does not appear to be a significant regulator of bone metabolism in eugonadal men .

###25173754
OBJECTIVE	We analyzed data collected during the Active Ulcerative Colitis Trials ( ACT-1 and ACT-2 ) to assess relationships between serum concentrations of infliximab and outcomes of adults with moderate-to-severe ulcerative colitis .
METHODS	We compared serum concentrations of infliximab with outcomes of 728 patients with moderately-to-severely active ulcerative colitis who participated in ACT-1 or ACT-2 ; efficacy data were collected at weeks 8 , 30 , and 54 ( for ACT-1 only ) .
METHODS	Relationships between serum concentration of infliximab and efficacy outcomes were assessed using trend , logistic regression , and receiver operating characteristic curve analyses .
METHODS	We also evaluated factors that affected the relationship between exposure and response .
RESULTS	Median serum concentrations of infliximab at weeks 8 , 30 , and/or 54 were significantly higher in patients with clinical response , mucosal healing , and/or clinical remission than in patients who did not meet these response criteria .
RESULTS	There were statistically significant relationships between quartile of infliximab serum concentration and efficacy at these time points ( P < .01 ) .
RESULTS	Infliximab therapy was effective for a smaller proportion of patients in the lowest quartile , and these patients had lower serum levels of albumin and a higher incidence of antibodies to infliximab than patients in other quartiles .
RESULTS	Although the relationship between exposure to infliximab and response varied among patients , approximate serum concentrations of 41 g/mL infliximab at week 8 of induction therapy and 3.7 g/mL at steady-state during maintenance therapy produced optimal outcomes in patients .
CONCLUSIONS	Serum concentrations of infliximab are associated with efficacy in patients with moderate-to-severe ulcerative colitis ; however , complex factors determine the relationship between exposure to this drug and response .
CONCLUSIONS	A prospective evaluation of the value of measuring serum concentrations of infliximab should be performed before these data can be included in patient management strategies .
CONCLUSIONS	Clinicaltrials.gov numbers : NCT00036439 and NCT00096655 .

###24627988
OBJECTIVE	To determine the feasibility of a multicentre randomised controlled trial ( RCT ) to investigate whether digital rotation of the fetal head from occiput posterior ( OP ) position in the second stage of labour reduces the risk of operative delivery ( defined as caesarean section ( CS ) or instrumental delivery ) .
METHODS	We conducted the study between December 2010 and December 2011 in a tertiary referral hospital in Australia .
METHODS	A transabdominal ultrasound was performed early in the second stage of labour on women with cephalic , singleton pregnancies to determine the fetal position .
METHODS	Those women with a fetus in the OP position were randomised to either a digital rotation or a sham procedure .
METHODS	In all other ways , participants received their usual intrapartum care .
METHODS	Data regarding demographics , mode of delivery , labour , post natal period and neonatal outcomes were collected .
RESULTS	One thousand and four women were consented , 834 achieved full dilatation , and 30 were randomised .
RESULTS	An additional portable ultrasound scan and a blinded ` sham ' digital rotation were acceptable to women and staff .
RESULTS	Operative delivery rates were 13/15 in the digital rotation ( four CS and nine instrumental ) and 12/15 in the sham ( three CS and nine instrumental ) groups , respectively .
CONCLUSIONS	A large double-blinded multicentre RCT would be feasible and acceptable to women and staff .
CONCLUSIONS	Strategies to improve recruitment such as consenting women with an effective epidural in active labour should be considered .
CONCLUSIONS	This would be the first RCT to answer a clinically important question which could significantly affect the operative delivery rate in Australia and internationally .

###25169488
OBJECTIVE	To observe the curative effects of rh-endostatin combined with DP regimen in treating patients with advanced esophageal cancer and analyze the correlation of CT perfusion ( CTP ) parameters and the expression of vascular endothelial growth factor ( VEGF ) .
METHODS	Twenty patients with esophageal cancer confirmed pathologically were randomly divided into combined treatment ( rh-endostatin + DP regimen ) group and single chemotherapy group , 10 patients in each group , respectively .
METHODS	All patients were given conventional CT examination and CTP imaging for primary tumor .
METHODS	The level of VEGF , the size of tumor and CTP parameters ( BF , BV , PS and MTT ) before treatment and after 2 cycles of treatment were determined for the comparison and the correlation between CTP parameters and VEGF expression was analyzed .
RESULTS	the therapeutic effect of rh-endostatin + DP regimen group was superior to single chemotherapy group .
RESULTS	VEGF level after treatment in rh - endostatin + DP regimen group was obviously lower than single chemotherapy group ( P < 0.01 ) .
RESULTS	The expression of VEGF had positive correlation with BF and BV but negative correlation with MTT .
RESULTS	Compared with treatment before for rh-endostatin + DP regimen group , BF , BV and PS decreased while MTT increased after treatment ( P < 0.05 ) .
RESULTS	However , there were no significant differences between treatment before and after treatment in single chemotherapy ( P > 0.05 ) .
CONCLUSIONS	Rh-endostatin can down-regulate the expression of VEGF in esophageal cancer , change the state of hypertransfusion and high permeability of tumor vessels and had the better curative effect and slighter adverse reactions when combined with chemotherapy .

###24476003
BACKGROUND	Although its excellent results , laparoscopic sleeve gastrectomy ( LSG ) presents major complications ranging from 0 % to 29 % .
BACKGROUND	Among them , the staple line leak presents an incidence varying from 0 % to 7 % .
BACKGROUND	Many trials debated about different solutions in order to reduce leaks ' incidence .
BACKGROUND	No author has investigated the role of gastric decompression in the prevention of this complication .
BACKGROUND	Aim of our work is to evaluate if this procedure can play a role in avoiding the occurrence of staple line leaks after LSG .
METHODS	Between January 2008 and November 2012 , 145 patients were prospectively and randomly included in the study .
METHODS	Seventy patients composed the group A , whose operations were completed with placement of nasogastric tube ; the other 75 patients were included in the group B , in which no nasogastric tube was placed .
RESULTS	No statistical differences were observed between group A and group B regarding gender distribution , age , weight , and BMI .
RESULTS	No intraoperative complications and no conversion occurred in both groups .
RESULTS	Intraoperative blood loss ( 50.1 42.3 vs. 52.5 37.6 ml , respectively ) and operative time ( 65.4 25.5 vs. 62.6 27.8 min , respectively ) were comparable between the two groups ( p : NS ) .
RESULTS	One staple line leak ( 1.4 % ) occurred on 6th postoperative day in group A patients .
RESULTS	No leak was observed in group B patients .
RESULTS	Postoperative hospital stay was significantly longer in group A vs. group B patients ( 7.6 3.4 vs. 6.2 3.1 days , respectively , p : 0.04 ) .
CONCLUSIONS	Routine placement of nasogastric tube in patients operated of LSG seems not useful in reducing leaks ' incidence .

###24836758
OBJECTIVE	To investigate the feasibility of conducting a cohort , factorial randomized controlled trial ( RCT ) in the treatment of patients with low back pain ( LBP ) .
METHODS	Pragmatic feasibility factorial RCT nested within an observational cohort study in two general practices in York , United Kingdom .
RESULTS	Eight hundred forty-five patients aged between 18 and 65years who had consulted their general practitioner about LBP within the preceding 12months were mailed an invitation to participate in a cohort trial , with the possibility of later joining a treatment RCT .
RESULTS	One hundred twenty-four patients consented to participate in the cohort and treatment trial , and one consented only to the cohort only .
RESULTS	Ultimately , 59 patients were randomized into the nested RCT .
RESULTS	Outcomes included recruitment , acceptability , and attrition rates as measures of the feasibility of the design and Roland Morris Disability Questionnaire .
RESULTS	No statistically significant differences in outcome between treatment groups and usual care were found .
CONCLUSIONS	The design was feasible for the evaluation of different back pain treatments .
CONCLUSIONS	We found zero attrition after randomization and showed that for a remitting relapsing condition , the design allows us to recruit initially ineligible patients from the cohort .
CONCLUSIONS	Additional statistical analysis using regression discontinuity can also be used with this design .

###24443547
BACKGROUND	Low-frequency nevirapine ( NVP ) - resistant variants have been associated with virologic failure ( VF ) of initial NVP-based combination antiretroviral therapy ( cART ) in women with prior exposure to single-dose NVP ( sdNVP ) .
BACKGROUND	We investigated whether a similar association exists in women without prior sdNVP exposure .
METHODS	Pre-cART plasma was analyzed by allele-specific polymerase chain reaction to quantify NVP-resistant mutants in human immunodeficiency virus-infected African women without prior sdNVP who were starting first-line NVP-based cART in the OCTANE/A5208 trial 2 .
METHODS	Associations between NVP-resistant mutants and VF or death were determined and compared with published results from women participating in the OCTANE/A5208 trial 1 who had taken sdNVP and initiated NVP-based cART .
RESULTS	Pre-cART NVP-resistant variants were detected in 18 % ( 39/219 ) of women without prior sdNVP exposure , compared to 45 % ( 51/114 ) with prior sdNVP exposure ( P < .001 ) .
RESULTS	Among women without prior sdNVP exposure , 8 of 39 ( 21 % ) with NVP-resistant variants experienced VF or death vs 31 of 180 ( 17 % ) without such variants ( P = .65 ) ; this compares with 21 of 51 ( 41 % ) vs 9 of 63 ( 14 % ) among women with prior exposure ( P = .001 ) .
CONCLUSIONS	The risk of VF on NVP-based cART from NVP-resistant variants differs between sdNVP-exposed and - unexposed women .
CONCLUSIONS	This difference may be driven by drug-resistance mutations emerging after sdNVP exposure that are linked on the same viral genome .
BACKGROUND	NCT00089505 .

###24377326
OBJECTIVE	The neurobehavioural symptoms and pain following traumatic brain injury ( TBI ) can be long-lasting .
OBJECTIVE	The condition impairs the persons ' ability to function in their work , studies and gatherings with family and friends .
OBJECTIVE	The aim of this study was to investigate dosage , safety and effects of methylphenidate on mental fatigue and pain .
METHODS	Twenty-nine physically-well rehabilitated TBI victims , 28 with a mild TBI and one with TBI and also with pain in the neck , shoulders and head were included in the study .
METHODS	Methylphenidate was tested in each patient using three treatment strategies : no medication , low dose ( 5mg3 ) and normal dose ( 20mg3 ) for 4 weeks using a randomized cross-over design .
RESULTS	Twenty-four patients completed the three treatment periods .
RESULTS	Five participants discontinued , four females due to adverse reactions and one male due to attenuated motivation .
RESULTS	Only minor adverse events were reported .
RESULTS	Methylphenidate significantly decreased mental fatigue , as evaluated by the Mental Fatigue Scale ( p < 0.001 ) , and the effects on mental fatigue were dose-dependent .
RESULTS	No effect on pain was detected .
CONCLUSIONS	Methylphenidate decreased mental fatigue for subjects suffering a traumatic brain injury , the treatment is considered to be safe and is recommended , starting with a low dose .

###24910546
OBJECTIVE	Patients with severe OSA consume greater amounts of cholesterol , protein , and fat as well as have greater caloric expenditure .
OBJECTIVE	However , it is not known whether their activity levels or diet change after treatment with CPAP .
OBJECTIVE	To investigate this issue , serial assessments of activity and dietary intake were performed in the Apnea Positive Pressure Long-term Efficacy Study ( APPLES ) ; a 6-month randomized controlled study of CPAP vs. sham CPAP on neurocognitive outcomes .
METHODS	Subjects were recruited into APPLES at 5 sites through clinic encounters or public advertisement .
METHODS	After undergoing a diagnostic polysomnogram , subjects were randomized to CPAP or sham if their AHI was 10 .
METHODS	Adherence was assessed using data cards from the devices .
METHODS	At the Tucson and Walla Walla sites , subjects were asked to complete validated activity and food frequency questionnaires at baseline and their 4-month visit .
RESULTS	Activity and diet data were available at baseline and after 4 months treatment with CPAP or sham in up to 231 subjects ( 117 CPAP , 114 Sham ) .
RESULTS	Mean age , AHI , BMI , and Epworth Sleepiness Score ( ESS ) for this cohort were 55 13 [ SD ] years , 44 27 / h , 33 7.8 kg/m ( 2 ) , and 10 4 , respectively .
RESULTS	The participants lacking activity and diet data were younger , had lower AHI and arousal index , and had better sleep efficiency ( p < 0.05 ) .
RESULTS	The BMI was higher among women in both CPAP and Sham groups .
RESULTS	However , compared to women , men had higher AHI only in the CPAP group ( 50 vs. 34 ) .
RESULTS	Similarly , the arousal index was higher among men in CPAP group .
RESULTS	Level of adherence defined as hours of device usage per night at 4 months was significantly higher among men in CPAP group ( 4.0 2.9 vs. 2.6 2.6 ) .
RESULTS	No changes in consumption of total calories , protein , carbohydrate or fat were noted after 4 months .
RESULTS	Except for a modest increase in recreational activity in women ( 268 85 vs. 170 47 calories , p < 0.05 ) , there also were no changes in activity patterns .
CONCLUSIONS	Except for a modest increase in recreational activity in women , OSA patients treated with CPAP do not substantially change their diet or physical activity habits after treatment .

###24930179
OBJECTIVE	The present experiment evaluated whether training involving throwing transferred to metric distance estimation ( i.e. , describing in feet and inches the distance between oneself and targets ) .
BACKGROUND	In prior work , we found that metric estimation training negatively transferred to throwing .
BACKGROUND	We explained our results in terms of cognitive intrusion .
BACKGROUND	The present study tested that possibility by swapping our training and transfer tasks .
METHODS	During pretesting , participants verbally estimated the metric distances between themselves and targets , or they threw a beanbag to targets .
METHODS	During training , participants donned goggles that distorted their vision .
METHODS	While wearing the goggles , they threw a beanbag to targets .
METHODS	Half received feedback .
METHODS	During posttesting , participants removed the distorting goggles and completed the same task that they performed during pretesting .
RESULTS	The results indicated that the distorting goggles degraded throwing at the beginning of training , visual feedback improved throwing during training , the effects of training with feedback persisted into the throwing posttest , and the effects of training with feedback did not transfer to the verbal metric estimation posttest .
CONCLUSIONS	Training involving throwing was effective , but did not transfer to verbal metric distance estimation .
CONCLUSIONS	This supports our argument that the negative transfer observed in our previous study stemmed from cognitive intrusion .
CONCLUSIONS	The present experiment suggests that the creation of distance estimation training should begin with a careful analysis of the transfer task , and that distance estimation training programs should explicitly teach trainees that their training will not generalize to all distance estimation tasks .

###25317722
BACKGROUND	Daily application of oral chlorhexidine gluconate ( CHX ) following intubation to reduce the risk of ventilator-associated pneumonia ( VAP ) is now the standard of care in many ICUs .
BACKGROUND	This randomized clinical trial evaluated the benefit of adding a preintubation CHX dose to the known benefit of postintubation CHX to reduce the risk of early-onset VAP .
BACKGROUND	A secondary aim was to test the effect of a preintubation oral application of CHX on early endotracheal tube ( ETT ) colonization .
METHODS	Subjects ( N = 314 ) were recruited from two teaching hospitals and were randomly assigned to oral application of 5 mL CHX 0.12 % solution before intubation ( intervention group , n = 157 ) , or to a control group ( n = 157 ) who received no CHX before intubation .
METHODS	All subjects received CHX bid after intubation .
METHODS	Groups were compared using a repeated-measures model with Clinical Pulmonary Infection Score ( CPIS ) as the response variable .
METHODS	In a planned subset of subjects , ETTs were cultured at extubation .
RESULTS	Application of a preintubation dose of CHX did not provide benefit over the intervention period beyond that afforded by daily oral CHX following intubation .
RESULTS	ETT colonization at extubation was < 20 % in both groups ( no statistically significant difference ) .
RESULTS	Mean CPIS remained below 6 ( VAP threshold score ) in both groups .
CONCLUSIONS	Although it is feasible to deliver CHX prior to intubation ( including emergent or urgent intubation ) , the results suggest that preintubation CHX may be inconsequential when the ventilator bundle , including daily oral CHX , is in place .
CONCLUSIONS	During the preintubation period , providers should focus their attention on other critical activities .
BACKGROUND	ClinicalTrials.gov ; No. : NCT00893763 ; URL : www.clinicaltrials.gov .

###24393553
OBJECTIVE	Linagliptin is a novel , highly selective and long acting DPP-4 inhibitor for the treatment of type 2 diabetes mellitus ( T2DM ) .
OBJECTIVE	Linagliptin exhibits non-linear pharmacokinetics ( PK ) due to saturable binding to plasma and tissue DPP-4 .
OBJECTIVE	The aim of this study was to characterize the PK and PK/DPP -4 inhibition relationship of linagliptin in Japanese patients with T2DM using a population PK/DPP -4 model and to support the rationale for the therapeutic dose in Japanese patients by simulation .
METHODS	Linagliptin plasma concentration and DPP-4 inhibition measurements from a placebo-controlled , parallel group multiple ( 28 days ) dose trial that included 36 T2DM patients ( 18 patients each in 2.5 mg and 10 mg dose group ) were used for analysis .
METHODS	Modeling was performed using FOCE INTERACTION estimation method implemented in NONMEM V.
METHODS	The linagliptin plasma concentration - and DPP-4 inhibition - time profiles were simulated for Japanese patients receiving 5 mg linagliptin once daily by the model established .
RESULTS	Nonlinear PK of linagliptin in T2DM patients were well described by a 2-compartment model assuming concentration-dependent binding to DPP-4 in the central and peripheral compartment .
RESULTS	Plasma DPP-4 inhibition was integrated in the model by relating the model-predicted DPP-4 occupancy with linagliptin linearly to DPP-4 inhibition .
RESULTS	The simulation predicted that for the 5 mg dose group the trough DPP-4 inhibition at steady-state was 84.2 % , which is higher than the target inhibition ( 80 % ) for an effective dose of DPP-4 inhibitor .
RESULTS	In 2.5 mg dose group , steady-state DPP-4 inhibition of > 80 % was not maintained over 24 hours ( observed and simulated ) .
CONCLUSIONS	The nonlinear PK of linagliptin and its plasma DPP-4 inhibition in patients were well characterized by a target-mediated drug disposition model relating DPP-4 occupancy with linagliptin to DPP-4 inhibition .
CONCLUSIONS	Simulations of plasma DPP-4 inhibition suggest that 5 mg linagliptin once daily is an appropriate therapeutic dose for Japanese patients with T2DM .

###24673050
OBJECTIVE	To compare the difference in the clinical efficacy on premature ovarian failure ( POF ) between the acupoint catgut implantation combined with artifical periodic therapy and the simple artificial periodic therapy and explore its effect mechanism .
METHODS	Sixty-five patients of POF were randomized into the two groups .
METHODS	In a western medication group , 32 cases were treated with the artificial periodic therapy with the oral administration of medroxyprogesterone acetate tablets .
METHODS	In a catgut implantation + western medication group , 33 cases were treated with the acupoint catgut implantation combined with artificial periodic therapy .
METHODS	The acupoints of Neiguan ( PC 6 ) , Zusanli ( ST 36 ) , Guanyuan ( CV 4 ) and Sanyinjiao ( SP 6 ) were selected .
METHODS	The treatment was lasted for half a year and the follow-up visit was for another half a year in the two groups .
METHODS	Kupperman index was used to assess the improvements in the clinical symptoms .
METHODS	The levels of serum sexual hormones such as follicle stimulating hormone ( FSH ) and estradiol ( E2 ) were evaluated of the patients in the two groups before and after treatment .
METHODS	The efficacy was compared between the two groups .
RESULTS	The scores of the clinical symptoms were all significantly improved after treatment and in the follow-up in the two groups ( P < 0.01 , P < 0.05 ) .
RESULTS	In the 6-month follow-up visit after treatment , the result in the catgut implantation + western medication group was better than that in the western medication group ( 8.17 + / - 1.19 vs 13.68 + / - 1.08 , P < 0.01 ) .
RESULTS	FSH was reduced after treatment in the two groups ( all P < 0.01 ) and E2 was increased ( all P < 0.05 ) .
RESULTS	The curative and remarkably effective rates were 75.8 % ( 25/33 ) and 81.8 % ( 27/22 ) after treatment and in the follow-up visit in the catgut implantation + western medication group , which were better than 67.9 % ( 19/28 ) and 53.6 % ( 15/28 ) in the western medication group separately ( P < 0.05 , P < 0.01 ) .
CONCLUSIONS	The acupoint catgut implantation combined with artificial periodic therapy achieve the remarkable improvements in the clinical symptoms of POF in the patients and the better results as compared with the simple western medication therapy .
CONCLUSIONS	The combined therapys efficacy is stable and the long-term efficacy is apparently superior .
CONCLUSIONS	The effect mechanism is related to the improvements in the serum sexual hormone levels .

###24990426
BACKGROUND	MicroRNAs have emerged as important epigenetic regulators in cardiovascular diseases ( CVDs ) .
BACKGROUND	Using an observational meta-analysis design , we previously characterized a gain-of-function microRNA-410 target site polymorphism ( rs13702T > C ) in the 3 ` untranslated region of the lipoprotein lipase ( LPL ) gene .
BACKGROUND	The C allele was associated with lower triglycerides , and this association was modulated by fat intake .
OBJECTIVE	We aimed to extend our findings by assessing the interaction between the rs13702 polymorphism and fat intake on triglycerides at baseline and longitudinally by using a dietary intervention design .
OBJECTIVE	We also examined as a primary outcome the association of this variant with CVD incidence and its modulation by the Mediterranean diet ( MedDiet ) .
METHODS	We studied 7187 participants in the PREDIMED ( Prevencin con Dieta Mediterrnea ) randomized trial that tested a MedDiet intervention compared with a control diet , with a median 4.8-y follow-up .
METHODS	LPL polymorphisms and triglycerides were determined and CVD assessed .
METHODS	Gene-diet interactions for triglycerides were analyzed at baseline ( n = 6880 ) and after a 3-y intervention ( n = 4131 ) .
METHODS	Oxidative stress parameters were investigated in a subsample .
RESULTS	The rs13702T > C polymorphism was strongly associated with lower triglycerides in C allele carriers and interacted synergistically with dietary monounsaturated ( P = 0.038 ) and unsaturated fat intake ( P = 0.037 ) , decreasing triglycerides at baseline .
RESULTS	By 3 y , we observed a gene-diet interaction ( P = 0.025 ) in which the C allele was associated with a greater reduction in triglycerides after intervention with MedDiet , high in unsaturated fat .
RESULTS	Although the polymorphism was associated with lower stroke risk ( HR : 0.74 ; 95 % CI : 0.57 , 0.97 ; P = 0.029 per C allele ) , this association reached statistical significance only in the MedDiet intervention ( HR : 0.58 ; 95 % CI : 0.37 , 0.91 ; P = 0.019 in C compared with TT carriers ) , not in the control group ( HR : 0.94 ; 95 % CI : 0.55 , 1.59 ; P = 0.805 ) .
CONCLUSIONS	We report a novel association between a microRNA target site variant and stroke incidence , which is modulated by diet in terms of decreasing triglycerides and possibly stroke risk in rs13702 C allele carriers after a high-unsaturated fat MedDiet intervention .

###25277416
BACKGROUND	Exercise and adequate self-management capacity may be important strategies in the management of venous leg ulcers .
BACKGROUND	However , it remains unclear if exercise improves the healing rates of venous leg ulcers and if a self-management exercise program based on self-efficacy theory is well adhered to .
METHODS	This is a randomised controlled in adults with venous leg ulcers to determine the effectiveness of a self-efficacy based exercise intervention .
METHODS	Participants with venous leg ulcers are recruited from 3 clinical sites in Australia .
METHODS	After collection of baseline data , participants are randomised to either an intervention group or control group .
METHODS	The control group receive usual care , as recommended by evidence based guidelines .
METHODS	The intervention group receive an individualised program of calf muscle exercises and walking .
METHODS	The twelve week exercise program integrates multiple elements , including up to six telephone delivered behavioural coaching and goal setting sessions , supported by written materials , a pedometer and two follow-up booster calls if required .
METHODS	Participants are encouraged to seek social support among their friends , self-monitor their weekly steps and lower limb exercises .
METHODS	The control group are supported by a generic information sheet that the intervention group also receive encouraging lower limb exercises , a pedometer for self-management and phone calls at the same time points as the intervention group .
METHODS	The primary outcome is the healing rates of venous leg ulcers which are assessed at fortnightly clinic appointments .
METHODS	Secondary outcomes , assessed at baseline and 12 weeks : functional ability ( range of ankle motion and Tinetti gait and balance score ) , quality of life and self-management scores .
CONCLUSIONS	This study seeks to address a significant gap in current wound management practice by providing evidence for the effectiveness of a home-based exercise program for adults with venous leg ulcers .
CONCLUSIONS	Theory-driven , evidence-based strategies that can improve an individual 's exercise self-efficacy and self-management capacity could have a significant impact in improving the management of people with venous leg ulcers .
CONCLUSIONS	Information gained from this study will provide much needed information on management of this chronic disease to promote health and independence in this population .
BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12612000475842 .

###25713437
OBJECTIVE	There is evidence from nonrandomized studies that a proportion of ipilimumab-treated patients with advanced melanoma experience long-term survival .
OBJECTIVE	To demonstrate a long-term survival benefit with ipilimumab , we evaluated the 5-year survival rates of patients treated in a randomized , controlled phase III trial .
METHODS	A milestone survival analysis was conducted to capture the 5-year survival rate of treatment-naive patients with advanced melanoma who received ipilimumab in a phase III trial .
METHODS	Patients were randomly assigned 1:1 to receive ipilimumab at 10 mg/kg plus dacarbazine ( n = 250 ) or placebo plus dacarbazine ( n = 252 ) at weeks 1 , 4 , 7 , and 10 followed by dacarbazine alone every 3 weeks through week 22 .
METHODS	Eligible patients could receive maintenance ipilimumab or placebo every 12 weeks beginning at week 24 .
METHODS	A safety analysis was conducted on patients who survived at least 5 years and continued to receive ipilimumab as maintenance therapy .
RESULTS	The 5-year survival rate was 18.2 % ( 95 % CI , 13.6 % to 23.4 % ) for patients treated with ipilimumab plus dacarbazine versus 8.8 % ( 95 % CI , 5.7 % to 12.8 % ) for patients treated with placebo plus dacarbazine ( P = .002 ) .
RESULTS	A plateau in the survival curve began at approximately 3 years .
RESULTS	In patients who survived at least 5 years and continued to receive ipilimumab , grade 3 or 4 immune-related adverse events were observed exclusively in the skin .
CONCLUSIONS	The additional survival benefit of ipilimumab plus dacarbazine is maintained with twice as many patients alive at 5 years compared with those who initially received placebo plus dacarbazine .
CONCLUSIONS	These results demonstrate a durable survival benefit with ipilimumab in advanced melanoma .

###24642148
OBJECTIVE	Urinary retention is one of the most common complications contributing to surgical procedures .
OBJECTIVE	Recent studies have shown the benefits of alpha-adrenergic blockers in preventing post-operative urinary retention ( POUR ) .
OBJECTIVE	The aim of this prospective study was to compare the prophylactic effect of tamsulosin with placebo on postoperative urinary retention .
METHODS	In this randomized placebo controlled , clinical trial , 232 male patients aged 18 to 50 years old admitted to Razi University Hospital for varicocelectomy , inguinal herniorrhaphy , and scrotal surgery were randomly assigned to receive either three doses of 0.4 mg tamsulosin ( n = 118 ) or placebo ( n = 114 ) , 14 and 2 hours before , and 10 hours after surgery .
METHODS	Patients were closely monitored for the development of urinary retention 24 hours after surgical intervention .
METHODS	The primary endpoint was to investigate the effect of tamsulosin in prevention of post-operative urinary retention during the first 24 hours after surgical intervention .
METHODS	Collected data were analyzed using SPSS software version 18 and the P < 0.05 was considered statistically significant .
RESULTS	One hundred and eighteen patients were included in tamsulosin arm and 114 in placebo arm .
RESULTS	POUR in patients who received tamsulosin was significantly lower than placebo , as 5.9 % of the patients treated with tamsulosin and 21.1 % placebo group , reported urinary retention following surgery ( P = 0.001 ) .
RESULTS	No serious adverse effects were seen in both groups .
CONCLUSIONS	This study suggests that short perioperative treatment with tamsulosin can reduce the incidence of urinary retention and the need for catheterization after varicocelectomy , inguinal herniorrhaphy , and scrotal surgery .

###24341333
BACKGROUND	Inflammatory bowel disease ( IBD ) is a chronic condition with an unpredictable disease course .
BACKGROUND	Rates of anxiety and depression among IBD patients in relapse ( active disease symptoms ) as well as in remission are higher than in the general population .
BACKGROUND	Previous studies suggest that the prolonged effect of pain , anxiety , distress and depression have a detrimental effect on patients ` quality of life ( QoL ) .
BACKGROUND	Poor QoL in itself is associated with further symptom relapse .
BACKGROUND	Mindfulness based cognitive therapy ( MBCT ) is a psychological group intervention that has the potential to improve QoL .
BACKGROUND	When used in other chronic conditions , it demonstrated reduced negative effect from pain and psychological factors at completion of an 8-week MBCT course .
BACKGROUND	The effect of MBCT has never been researched in IBD .
BACKGROUND	The aim of this study is to obtain the information required to design a full scale randomised controlled trial ( RCT ) that will examine the effectiveness of MBCT in improving quality of life for IBD patients .
METHODS	This is an exploratory RCT with embedded process evaluation .
METHODS	Forty IBD patients will be recruited from NHS outpatient gastroenterology clinics and will be randomised to either a MBCT ( intervention ) group or to a wait-list ( control ) group .
METHODS	All participants will undergo 16 h of structured group training over an 8-week period , with the control group starting 6 months later than the intervention group .
METHODS	Primary outcomes are recruitment , completion/retention rates and adherence and adaptation to the MBCT manual for IBD patients .
METHODS	The secondary outcome is to assess the feasibility of collecting reliable and valid data on proposed outcome measures such as quality of life , anxiety , depression , disease activity and mindful awareness .
METHODS	The process evaluation will use a survey and focus groups to assess the acceptability of the intervention and trial procedures for IBD patients .
CONCLUSIONS	The outcomes of this study will help define the barriers , uptake and perceived benefits of MBCT program for IBD patients .
CONCLUSIONS	This information will enable the design of a full-scale study assessing the effect of MBCT on quality of life for IBD patients .
BACKGROUND	Current Controlled Trials : ISRCTN27934462 .

###24885921
BACKGROUND	General anesthesia usually requires mechanical ventilation , which is traditionally accomplished with constant tidal volumes in volume - or pressure-controlled modes .
BACKGROUND	Experimental studies suggest that the use of variable tidal volumes ( variable ventilation ) recruits lung tissue , improves pulmonary function and reduces systemic inflammatory response .
BACKGROUND	However , it is currently not known whether patients undergoing open abdominal surgery might benefit from intraoperative variable ventilation .
METHODS	The PROtective VARiable ventilation trial ( ` PROVAR ' ) is a single center , randomized controlled trial enrolling 50 patients who are planning for open abdominal surgery expected to last longer than 3hours .
METHODS	PROVAR compares conventional ( non-variable ) lung protective ventilation ( CV ) with variable lung protective ventilation ( VV ) regarding pulmonary function and inflammatory response .
METHODS	The primary endpoint of the study is the forced vital capacity on the first postoperative day .
METHODS	Secondary endpoints include further lung function tests , plasma cytokine levels , spatial distribution of ventilation assessed by means of electrical impedance tomography and postoperative pulmonary complications .
CONCLUSIONS	We hypothesize that VV improves lung function and reduces systemic inflammatory response compared to CV in patients receiving mechanical ventilation during general anesthesia for open abdominal surgery longer than 3hours .
CONCLUSIONS	PROVAR is the first randomized controlled trial aiming at intra - and postoperative effects of VV on lung function .
CONCLUSIONS	This study may help to define the role of VV during general anesthesia requiring mechanical ventilation .
BACKGROUND	Clinicaltrials.gov NCT01683578 ( registered on September 3 3012 ) .

###25741816
OBJECTIVE	To evaluate visual function in patients with symptomatic vitreomacular adhesion ( VMA ) / vitreomacular traction including when associated with macular hole after ocriplasmin treatment , and the association between resolution of the underlying condition and improvement in visual function .
METHODS	Six hundred and fifty-two patients from 2 Phase 3 trials received a single intravitreal injection of ocriplasmin 125 g ( n = 464 ) or placebo ( n = 188 ) .
METHODS	Mean and categorical changes from baseline in best-corrected visual acuity and 25-item Visual Function Questionnaire scores were used to evaluate visual function .
METHODS	Subgroups with VMA resolution and full-thickness macular hole closure were compared .
RESULTS	Overall , 42 % of patients who achieved VMA resolution at Day 28 had a 2-line improvement in best-corrected visual acuity at Month 6 , and 20 % had a 3-line improvement .
RESULTS	Likewise , 69 % of patients with nonsurgical full-thickness macular hole closure at Day 28 had a 2-line improvement at Month 6 , and 48 % had a 3-line best-corrected visual acuity improvement .
RESULTS	Mean improvements in 25-item Visual Function Questionnaire scores were associated with achieving VMA resolution and nonsurgical full-thickness macular hole closure .
CONCLUSIONS	In patients with symptomatic VMA/vitreomacular traction , VMA resolution and nonsurgical full-thickness macular hole closure were each associated with improvements in visual function .
CONCLUSIONS	Resolving the underlying anatomical condition in symptomatic VMA/vitreomacular traction will increase the probability of achieving a clinically meaningful improvement in visual function .

###25295771
BACKGROUND	It is well established in the literature that regular participation in physical activity is effective for chronic disease management and prevention .
BACKGROUND	Remote monitoring technologies ( ie , mHealth ) hold promise for engaging patients in self-management of many chronic diseases .
BACKGROUND	The purpose of this study was to test the effectiveness of an mHealth study with tailored physical activity prescription targeting changes in various intensities of physical activity ( eg , exercise , sedentary behavior , or both ) for improving physiological and behavioral markers of lifestyle-related disease risk .
METHODS	Forty-five older adults ( aged 55-75 years ; mean age 63 5 years ) were randomly assigned to receive a personal activity program targeting changes to either daily exercise , sedentary behavior , or both .
METHODS	All participants received an mHealth technology kit including smartphone , blood pressure monitor , glucometer , and pedometer .
METHODS	Participants engaged in physical activity programming at home during the 12-week intervention period and submitted physical activity ( steps/day ) , blood pressure ( mm Hg ) , body weight ( kg ) , and blood glucose ( mmol/L ) measures remotely using study-provided devices .
RESULTS	There were no differences between groups at baseline ( P > 0.05 ) .
RESULTS	The intervention had a significant effect ( F ( 10 488 ) = 2.947 , P = 0.001 , P = 0.057 ) , with similar changes across all groups for physical activity , body weight , and blood pressure ( P > 0.05 ) .
RESULTS	Changes in blood glucose were significantly different between groups , with groups prescribed high-intensity activity ( ie , exercise ) demonstrating greater reductions in blood glucose than the group prescribed changes to sedentary behavior alone ( P < 0.05 ) .
CONCLUSIONS	Findings demonstrate the utility of pairing mHealth technologies with activity prescription for prevention of lifestyle-related chronic diseases among an at-risk group of older men and women .
CONCLUSIONS	RESULTS support the novel approach of prescribing changes to sedentary behaviors ( alone , and in conjunction with exercise ) to reduce risk of developing lifestyle-related chronic conditions .

###24972761
OBJECTIVE	To examine the feasibility of collecting data relating to irritable bowel syndrome ( IBS ) , symptoms by short message service ( SMS ) text and explore the data to assess its usefulness .
METHODS	In a randomized parallel group design substudy , 59 consenting participants recruited from primary care to a trial of acupuncture for IBS ( ISRCTN 08827905 ) were randomized to receive a one-question SMS message at either 9:30 am or at 6:30 pm for 7days : `` On a scale of 0-9 , with 0 being no symptoms and 9 being the worst symptoms you could have , how would you score your IBS symptoms now ?
METHODS	Please text back a single number . ''
RESULTS	Of the total messages , 59 % ( n = 203 ) were answered within 15minutes , 73.4 % ( n = 254 ) within 1hour , and 97 % ( n = 334 ) within 10hours .
RESULTS	Response rates to evening texts were higher ( 93.5 % vs. 87.6 % P = 0.05 ) and response times shorter though not significantly ( median : 0 vs. 5hours ; P = 0.12 ) .
RESULTS	There was no difference in mean scores , and morning symptoms varied more .
RESULTS	Mean scores correlated significantly with IBS trial primary outcome measure , the IBS symptom severity score , and secondary outcome measures .
CONCLUSIONS	Among IBS trial participants , data collection by SMS is feasible and acceptable , and there is potential for deriving meaningful data from the scores .

###25372313
OBJECTIVE	Keratosis pilaris ( KP ) is a common skin disorder of follicular prominence and erythema that typically affects the proximal extremities , can be disfiguring , and is often resistant to treatment .
OBJECTIVE	Shorter-wavelength vascular lasers have been used to reduce the associated erythema but not the textural irregularity .
OBJECTIVE	To determine whether the longer-wavelength 810-nm diode laser may be effective for treatment of KP , particularly the associated skin roughness/bumpiness and textural irregularity .
METHODS	We performed a split-body , rater-blinded , parallel-group , balanced ( 1:1 ) , placebo-controlled randomized clinical trial at a dermatology outpatient practice of an urban academic medical center from March 1 to October 1 , 2011 .
METHODS	We included all patients diagnosed as having KP on both arms and Fitzpatrick skin types I through III .
METHODS	Of the 26 patients who underwent screening , 23 met our enrollment criteria .
METHODS	Of these , 18 patients completed the study , 3 were lost to or unavailable for follow-up , and 2 withdrew owing to inflammatory hyperpigmentation after the laser treatment .
METHODS	Patients were randomized to receive laser treatment on the right or left arm .
METHODS	Each patient received treatment with the 810-nm pulsed diode laser to the arm randomized to be the treatment site .
METHODS	Treatments were repeated twice , for a total of 3 treatment visits spaced 4 to 5 weeks apart .
METHODS	The primary outcome measure was the difference in disease severity score , including redness and roughness/bumpiness , with each graded on a scale of 0 ( least severe ) to 3 ( most severe ) , between the treated and control sites .
METHODS	Two blinded dermatologists rated the sites at 12 weeks after the initial visit .
RESULTS	At follow-up , the median redness score reported by the 2 blinded raters for the treatment and control sides was 2.0 ( interquartile range [ IQR ] , 1-2 ; P = .11 ) .
RESULTS	The median roughness/bumpiness score was 1.0 ( IQR , 1-2 ) for the treatment sides and 2.0 ( IQR , 1-2 ) for the control sides , a difference of 1 ( P = .004 ) .
RESULTS	The median overall score combining erythema and roughness/bumpiness was 3.0 ( IQR , 2-4 ) for the treatment sides and 4.0 ( IQR , 3-5 ) for the control sides , a difference of 1 ( P = .005 ) .
CONCLUSIONS	Three treatments with the 810-nm diode laser may induce significant improvements in skin texture and roughness/bumpiness in KP patients with Fitzpatrick skin types I through III , but baseline erythema is not improved .
CONCLUSIONS	Complete treatment of erythema and texture in KP may require diode laser treatment combined with other laser or medical modalities that address redness .
BACKGROUND	clinicaltrials.gov Identifier : NCT01281644 .

###25369449
OBJECTIVE	To determine the association between nonalcoholic fatty liver disease ( NAFLD ) and the presence of high-risk coronary atherosclerotic plaque as assessed with coronary computed tomographic ( CT ) angiography .
METHODS	This study was approved by the local ethics committees ; informed consent was obtained .
METHODS	Patients randomized to the coronary CT angiography arm of the Rule Out Myocardial Infarction using Computer Assisted Tomography , or ROMICAT , II trial who underwent both nonenhanced CT to assess calcium score and contrast material-enhanced coronary CT angiography were included .
METHODS	Readers assessed coronary CT angiography images for the presence of coronary plaque , significant stenosis ( 50 % ) , and high-risk plaque features ( positive remodeling , CT attenuation < 30 HU , napkin-ring sign , spotty calcium ) .
METHODS	NAFLD was defined as hepatic steatosis at nonenhanced CT ( liver minus spleen CT attenuation < 1 HU ) without evidence of clinical liver disease , liver cirrhosis , or alcohol abuse .
METHODS	To determine the association between high-risk plaque and NAFLD , univariable and multivariable logistic regression analyses were performed , with high-risk plaque as a dependent variable and NAFLD , traditional risk factors , and extent of coronary atherosclerosis as independent variables .
RESULTS	Overall , 182 ( 40.9 % ) of 445 patients had CT evidence of NAFLD .
RESULTS	High-risk plaque was more frequent in patients with NAFLD than in patients without NAFLD ( 59.3 % vs 19.0 % , respectively ; P < .001 ) .
RESULTS	The association between NAFLD and high-risk plaque ( odds ratio , 2.13 ; 95 % confidence interval : 1.18 , 3.85 ) persisted after adjusting for the extent and severity of coronary atherosclerosis and traditional risk factors .
CONCLUSIONS	NAFLD is associated with advanced high-risk coronary plaque , independent of traditional cardiovascular risk factors and the extent and severity of coronary artery disease .

###25402657
BACKGROUND	Bioimpedance analysis ( BIA ) is well established to assess body composition .
BACKGROUND	Agreements between single - and multi-frequency bioimpedance ( SF-BIA , MF-BIS ) measurements in subjects undergoing 6 or 3 times/week hemodialysis ( HD ) were analyzed .
METHODS	Total body water ( TBW ) and intra - and extracellular fluid ( ICF , ECF ) of subjects enrolled in the Frequent Hemodialysis Network ( FHN ) Daily Trial ( www.clinicaltrials.gov No .
METHODS	NCT00264758 ) were measured with a Hydra 4200 at baseline ( BL ) and at 5 months ( M5 ) .
METHODS	Volumes were computed using SF ( at 50 kHz ) and MF approaches .
METHODS	Agreement was assessed by means of linear regression and Bland-Altman analysis and treatment effects by t test .
RESULTS	35 subjects ( 17 on the more frequent regimen , 26 males , 20 African-American , 48 9 years , pre-HD weight 84 19 kg ) were studied .
RESULTS	Assessments with SF-BIA and MF-BIS correlated significantly at BL and M5 in both arms .
RESULTS	No proportional errors , but systematic biases over the entire range of values were found at BL and M5 .
RESULTS	Agreement did not differ between subjects randomized to either HD treatment arm at both time points .
RESULTS	MF-BIS appears to have better precision than SF-BIA allowing the observation of a significant treatment effect by the intervention [ -1.5 ( 95 % CI -2.5 to -0.5 ) l ] on ECF , not found for ECF SF-BIA .
RESULTS	Precision also affected the statistical power of the SF-BIA data in the current analysis .
CONCLUSIONS	Both methods showed agreement without significant proportional errors regardless of HD frequency and can be used for longitudinal analyses .
CONCLUSIONS	SF-BIA has lower precision which needs thorough consideration in the design of future trials with similar outcomes .

###24626270
OBJECTIVE	To determine the efficacy of chest compression accompanied by a 10-cmH2O increase in baseline inspiratory pressure on pressure support ventilation , in comparison with that of aspiration alone , in removing secretions , normalizing hemodynamics , and improving respiratory mechanics in patients on mechanical ventilation .
METHODS	This was a randomized crossover clinical trial involving patients on mechanical ventilation for more than 48 h in the ICU of the Porto Alegre Hospital de Clnicas , in the city of Porto Alegre , Brazil .
METHODS	Patients were randomized to receive aspiration alone ( control group ) or compression accompanied by a 10-cmH2O increase in baseline inspiratory pressure on pressure support ventilation ( intervention group ) .
METHODS	We measured hemodynamic parameters , respiratory mechanics parameters , and the amount of secretions collected .
RESULTS	We included 34 patients .
RESULTS	The mean age was 64.2 14.6 years .
RESULTS	In comparison with the control group , the intervention group showed a higher median amount of secretions collected ( 1.9 g vs. 2.3 g ; p = 0.004 ) , a greater increase in mean expiratory tidal volume ( 16 69 mL vs. 56 69 mL ; p = 0.018 ) , and a greater increase in mean dynamic compliance ( 0.1 4.9 cmH2O vs. 2.8 4.5 cmH2O ; p = 0.005 ) .
CONCLUSIONS	In this sample , chest compression accompanied by an increase in pressure support significantly increased the amount of secretions removed , the expiratory tidal volume , and dynamic compliance .
CONCLUSIONS	( ClinicalTrials.gov Identifier : NCT01155648 [ http://www.clinicaltrials.gov/] ) .

###24461175
OBJECTIVE	This study aimed to evaluate the effectiveness of multi-disciplinary treatment approaches in reducing neurological disabilities in premature infants .
METHODS	A total of 117 infants who were born premature in our hospital between March 2008 and February 2010 but had no congenital malformations and no severe neonatal complications , were enrolled in this study .
METHODS	They were randomly allocated to a multi-disciplinary treatment group ( n = 63 ) and a control group ( n = 54 ) .
METHODS	While patients in the control group underwent an early conventional treatment , those in the multi-disciplinary treatment group were subjected to regular development monitoring , neurological examination and screening for brain injury , neuro-nutrition and neurodevelopment therapies , and rehabilitation training .
RESULTS	The incidence rates of abnormalities in posture , reflex , sleep , muscle tone and EEG were significantly lower in the multi-disciplinary treatment group than in the control froup ( P < 0.05 ) at corrected postnatal ages of 6-12 months .
RESULTS	At corrected postnatal ages of 6 , 12 , 18 and 24 months , both mental development index ( MDI ) and psychomotor development index ( PDI ) scores were significantly higher in the multi-disciplinary treatment group than in the control group ( P < 0.05 ) .
RESULTS	At corrected postnatal age of 3 years , incidence rates of cerebral palsy , language barrier , abnormal muscle tone and hearing impairment were significantly lower in the multi-disciplinary treatment group than in the control group ( P < 0.05 ) .
CONCLUSIONS	Early multi-disciplinary intervention approaches may significantly improve mental and motor developments and reduce the incidence of cerebral palsy-associated neurological disabilities in premature infants .

###25109720
OBJECTIVE	Enhanced muscle strength is seen when resistance exercise is combined with the consumption of nutritional supplements .
OBJECTIVE	Although there is a limited number of studies available about the efficacy of gamma oryzanol supplementation with resistance exercise in humans , but its usage as a nutritional supplement for strength is common in athletes .
OBJECTIVE	The aim of this study was to determine the effects of gamma oryzanol supplementation during 9-week resistance training on muscular strength and anthropometric measurements of young healthy males .
METHODS	In this double-blind clinical trial , changes of anthropometric measurements and muscular strength were studied after chronic resistance exercise and gamma oryzanol supplementation in 30 healthy volunteers ( 16 in supplement and 14 in placebo ) .
METHODS	Each day , gamma oryzanol supplement ( 600 mg ) and placebo ( the same amount of lactose ) were consumed after training .
METHODS	The participants exercised with 80 per cent 1-Repetition Maximum ( 1-RM ) , for one hour and four days/week .
METHODS	Anthropometric measurements and subjects ' 1-RM for muscular strength were determined at the commencement and end of the 9-week study .
RESULTS	There was no significant difference between the baseline characteristics and target variables at baseline between the two groups .
RESULTS	After gamma oryzanol supplementation , there was no significant difference in the means of anthropometric and skin fold measurements between the supplement and placebo groups .
RESULTS	However , there were significant differences between the supplement and placebo groups for 1-RM of bench press and leg curl , which showed that gamma oryzanol improved muscle strength following resistance training .
CONCLUSIONS	Our findings indicated that 600 mg/day gamma oryzanol supplementation during the 9-week resistance training did not change anthropometric and body measurements , but it increased muscular strength in young healthy males .
CONCLUSIONS	Further , studies need to be done in trained athletes , women , and in patients who suffer from muscular fatigue .

###25677311
BACKGROUND	Bifurcation lesions are frequent among patients with symptomatic coronary disease treated by percutaneous coronary intervention .
BACKGROUND	Current evidence recommends a conservative ( provisional ) approach when treating the side branch ( SB ) .
OBJECTIVE	The TRYTON ( Prospective , Single Blind , Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries ) bifurcation trial sought to compare treatment of de novo true bifurcation lesions using a dedicated bifurcation stent or SB balloon angioplasty .
METHODS	We randomly assigned patients with true bifurcation lesions to a main vessel stent plus provisional stenting or the bifurcation stent .
METHODS	The primary endpoint ( powered for noninferiority ) was target vessel failure ( TVF ) ( cardiac death , target vessel myocardial infarction , and target vessel revascularization ) .
METHODS	The secondary angiographic endpoint ( powered for superiority ) was in-segment percent diameter stenosis of the SB at 9 months .
RESULTS	We randomized 704 patients with bifurcation coronary lesions at 58 centers ( 30 from Europe and 28 from the United States ) .
RESULTS	At 9 months , TVF was 17.4 % in the bifurcation stent group compared with 12.8 % in the provisional group ( p = 0.11 ) , mainly because of a higher periprocedural myocardial infarction rate ( 13.6 % vs. 10.1 % , p = 0.19 ) .
RESULTS	The TVF difference of +4.6 % ( 2-sided 95 % confidence interval : -1.0 to 10.3 ; upper limit of the 1-sided 95 % confidence interval : 10.3 ) was not within the pre-specified noninferiority margin of 5.5 % ( p = 0.42 for noninferiority ) .
RESULTS	The SB in-segment diameter stenosis among the angiographic cohort was lower in the bifurcation stent group compared with the provisional group ( 31.6 % vs. 38.6 % , p = 0.002 for superiority ) , with no difference in binary restenosis rates ( diameter stenosis50 % ) at 9 months follow-up ( 22.6 % vs. 26.8 % , p = 0.44 ) .
CONCLUSIONS	Provisional stenting should remain the preferred strategy for treatment of non-left main true coronary bifurcation lesions .
CONCLUSIONS	( Prospective , Single Blind , Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries [ TRYTON ] ; NCT01258972 ) .

###25242059
BACKGROUND	Individuals with physical disabilities experience disparities in obesity ; yet few interventions have incorporated accommodations necessary for weight loss in this population .
OBJECTIVE	This project compared the effectiveness of two weight loss interventions among individuals with physical disabilities .
METHODS	Adults with physical disabilities who were overweight or obese were randomized across two diet approaches : a modified version of the MyPlate diet ( usual care ( UC ) ) and a modified Stoplight Diet ( SLDm ) supplemented with portion-controlled meals .
METHODS	Project staff met monthly with each participant to measure weight , 24-recalls of diet intake , self-tracking of foods and beverages , and physical activity during the preceding month .
RESULTS	Of 126 enrollees , 70 % completed the initial 6-month diet phase and 60 % of these completed a 6-month follow-up phase .
RESULTS	Participants in the SLDm group reduced weight and BMI during the 6 month intervention , and maintained or lost more weight during the 6 month maintenance period .
RESULTS	Alternately , the UC diet resulted in a reduction in weight and BMI only at 6 months .
RESULTS	BMI from baseline was significantly more improved for SLDm than UC and , among those who lost weight , the SLDm group lost more weight at 6 and 12 months .
CONCLUSIONS	These results demonstrate that interventions with proper design and accommodations can overcome the barriers to weight loss unique to individuals with mobility impairments with low income .
CONCLUSIONS	Additionally , the results suggest that using portion control may be more effective than teaching portion sizes .

###24224738
BACKGROUND	Previous studies have reported that obese people with trisomy 21 suffer from low-grade systemic inflammation .
BACKGROUND	A recent study has found that aerobic training reduced inflammation in obese women with Down syndrome .
BACKGROUND	To the best of our knowledge , the study reported in this paper is the first to determine for how long these effects were maintained after completion of the programme .
METHODS	Twenty premenopausal obese women ( 18-30 years old ) with Down syndrome volunteered for this study .
METHODS	Eleven were randomly assigned to the intervention group and performed a 10-week aerobic training programme , 3 sessions per week , consisting of warming-up followed by treadmill exercise ( 30-40 min ) at a work intensity of 55-65 % of peak heart rate and a cooling-down period .
METHODS	The control group included 9 , age , sex and BMI matched women with Down syndrome that did not perform any training programme .
METHODS	Fat mass percentage and distribution were measured .
METHODS	Plasma level of IL-6 and high-sensitive C-reactive protein ( hs-CRP ) were monitored .
METHODS	Time-course changes for these outcomes were assessed at pre - and post-intervention .
METHODS	Further , they were re-evaluated at 1 , 3 and 6 months after completion of the programme .
RESULTS	Three months after completion of the programme , plasma levels of IL-6 and hs-CRP were significantly increased .
RESULTS	Up to 6 months later , both fat mass percentage and waist circumference ( WC ) were significantly increased .
RESULTS	Furthermore , physical fitness was also impaired in the intervention group .
RESULTS	No changes were observed in the control group .
CONCLUSIONS	A 3-month detraining period significantly impaired chronic inflammation in obese women with DS .

###25694460
OBJECTIVE	Physicians are a commonly targeted group in health research surveys , but their response rates are often relatively low .
OBJECTIVE	The goal of this paper was to evaluate the effect of unconditional incentives in the form of a coffee card on physician postal survey response rates .
METHODS	Following 13 key informant interviews and eight cognitive interviews a survey questionnaire was developed .
METHODS	A random sample of 534 physicians , stratified by physician group ( geriatricians , family physicians , emergency physicians ) was selected from a national medical directory .
METHODS	Using computer generated random numbers ; half of the physicians in each stratum were allocated to receive a coffee card to a popular national coffee chain together with the first survey mailout .
METHODS	The intervention was a $ 10 Tim Hortons gift card given to half of the physicians who were randomly allocated to receive the incentive .
RESULTS	265 ( 57.0 % ) physicians completed the survey .
RESULTS	The response rate was significantly higher in the group allocated to receive the incentive ( 62.7 % vs 51.3 % in the control group ; p = 0.01 ) .
CONCLUSIONS	Our results indicate that an unconditional incentive in the form of a coffee gift card can substantially improve physician response rates .
CONCLUSIONS	Future research can look at the effect of varying amounts of cash on the gift cards on response rates .

###25261378
BACKGROUND	In resource-poor settings , cold chain requirements present barriers for vaccine delivery .
BACKGROUND	We evaluated the immunogenicity and safety of tetanus toxoid ( TT ) vaccine in `` Controlled Temperature Chain '' ( CTC ; up to 40 C for < 30 days before administration ) , compared to standard cold chain ( SCC ; 2-8 C ) .
BACKGROUND	Prior to the study , stability parameters of TT-CTC were shown to meet international requirements .
METHODS	A cluster randomized , non-inferiority trial was conducted in Mossala district , Chad , December 2012-March 2013 .
METHODS	Thirty-four included clusters were randomized to CTC or SCC .
METHODS	Women aged 14-49 years , eligible for TT vaccination and with a history of 1 TT dose , received two TT doses 4 weeks apart .
METHODS	Participants were blinded to allocation strategy .
METHODS	Tetanus antibody titers were measured using standard ELISA at inclusion and 4 weeks post-TT2 .
METHODS	Primary outcome measures were post-vaccination seroconversion and fold-increase in geometric mean concentrations ( GMC ) .
METHODS	Non-inferiority was by seroconversion difference ( TTSCC-TTCTC ) < 5 % and ratio of GMCs ( TTSCC/TTCTC ) < 1.5 .
METHODS	Adverse events were monitored at health centers and at next contact with participants .
RESULTS	A total of 2128 women ( CTC = 1068 ; SCC = 1060 ) were recruited .
RESULTS	Primary intention to vaccinate analysis included 1830 participants ; 272 of these were included in the seroconversion analysis .
RESULTS	Seroconversion was reached by > 95 % of participants ; upper 95 % CI of the difference was 5.6 % .
RESULTS	Increases in GMC were over 4-fold ; upper 95 % CI of GMC ratio was 1.36 in the adjusted analysis .
RESULTS	Few adverse events were recorded .
CONCLUSIONS	This study demonstrates the immunogenicity and safety of TT in CTC at < 40 C for < 30 days .
CONCLUSIONS	The high proportion of participants protected at baseline results in a reduction of power to detect a 5 % non-inferiority margin .
CONCLUSIONS	However , results at a 10 % non-inferiority margin , the comparable GMC increases and vaccine 's stability demonstrated in the preliminary phase indicate that CTC can be an alternative strategy for TT delivery in situations where cold chain can not be maintained .

###25213352
OBJECTIVE	Although prevailing spinal nerve involvement has been recognized in a few detailed Guillain-Barr syndrome ( GBS ) autopsy reports , imaging studies addressing this question in cervical nerves are lacking .
METHODS	We describe clinical , electrophysiological , ultrasonographic ( US ) and pathological findings in six consecutive early GBS patients , evaluated within 10 days of onset .
RESULTS	Patients ' ages ranged from 37 to 80 years .
RESULTS	Five patients required mechanical ventilation , two of them having died 9 and 28 days after onset .
RESULTS	Upper - and lower-limb nerve US showed abnormal findings in just 8.8 % of scanned peripheral nerves .
RESULTS	In comparison with 46 aged-matched control subjects , US of the fifth to seventh cervical nerves showed changes in four cases , which consisted of significant nerve enlargement , blurred boundaries of the corresponding ventral rami , or both .
RESULTS	Autopsy study in one case demonstrated that pathology , consisting of demyelination and endoneurial inflammatory oedema , mainly involved cervical and lumbar nerves .
CONCLUSIONS	In early GBS inflammatory oedema of spinal nerves is a pathogenically relevant feature to understanding the mechanism of ascending paralysis , particularly when conventional electrophysiological studies are normal or not diagnostic .
CONCLUSIONS	Findings advocate the use of cervical nerve US in early GBS .

###24816724
OBJECTIVE	AIO KRK-0104 investigated first-line therapy of metastatic colorectal cancer ( mCRC ) with cetuximab , capecitabine and irinotecan versus cetuximab , capecitabine and oxaliplatin .
OBJECTIVE	This analysis investigated the impact of primary tumor location on outcome of patients .
METHODS	Left-sided primary tumors were defined as tumors from rectum to left flexure , while tumors in the remaining colon were regarded right sided .
METHODS	Overall survival ( OS ) , progression-free survival ( PFS ) and response rate were correlated with primary tumor location .
METHODS	A Cox regression model was used to evaluate interaction between primary tumor location and KRAS mutation .
RESULTS	Of 146 patients of the AIO KRK-0104 trial , 100 patients presented left-sided ( of those 68 KRAS codon 12/13 wild-type ) and 46 patients right-sided primary tumors ( of those 27 KRAS codon 12/13 wild-type ) .
RESULTS	Left-sided tumors were associated with significantly longer OS ( p = 0.016 , HR = 0.63 ) and PFS ( p = 0.02 , HR = 0.67 ) as compared to right-sided tumors .
RESULTS	These effects were present in the KRAS codon 12/13 wild-type population ( HR OS : 0.42 ; HR PFS : 0.54 ) , while no impact of primary tumor location was evident in patients with KRAS codon 12/13 mutant tumors ( HR OS : 1.3 ; HR PFS : 1.01 ) .
RESULTS	A significant interaction of KRAS status and primary tumor location concerning OS and PFS was observed .
CONCLUSIONS	Our findings suggest that primary tumor location and KRAS codon 12/13 mutational status interact on the outcome of patients with mCRC receiving cetuximab-based first-line therapy .
CONCLUSIONS	Left-sided primary tumor location might be a predictor of cetuximab efficacy .

###25002661
BACKGROUND	The ideal preparation regimen for pediatric colonoscopy remains elusive , and available preparations continue to represent a challenge for children .
BACKGROUND	The aim of this study was to compare the efficacy , safety , tolerability , and acceptance of 4 methods of bowel cleansing before colonoscopy in children .
METHODS	This randomized , investigator-blinded , noninferiority trial enrolled all children aged 2 to 18 years undergoing elective colonoscopy in a referral center for pediatric gastroenterology .
METHODS	Patients were randomly assigned to receive polyethylene glycol ( PEG ) 4000 with simethicon ( PEG-ELS group ) or PEG-4000 with citrates and simethicone plus bisacodyl ( PEG-CS + Bisacodyl group ) , or PEG 3350 with ascorbic acid ( PEG-Asc group ) , or sodium picosulfate plus magnesium oxide and citric acid ( NaPico + MgCit group ) .
METHODS	Bowel cleansing was evaluated according to the Boston Bowel Preparation Scale .
METHODS	The primary end point was overall colon cleansing .
METHODS	Tolerability , acceptability , and compliance were also evaluated .
RESULTS	Two hundred ninety-nine patients were randomly allocated to the 4 groups .
RESULTS	In the per-protocol analysis , PEG-CS + Bisacodyl , PEG-Asc , and NaPico + MgCit were noninferior to PEG-ELS in bowel-cleansing efficacy of both the whole colon ( P = .910 ) and colonic segments .
RESULTS	No serious adverse events occurred in any group .
RESULTS	Rates of tolerability , acceptability , and compliance were significantly higher in the NaPico + MgCit group .
CONCLUSIONS	Low-volume PEG preparations ( PEG-CS + Bisacodyl , PEG-Asc ) and NaPico + MgCit are noninferior to PEG-ELS in children , representing an attractive alternative to high-volume regimens in clinical practice .
CONCLUSIONS	Because of the higher tolerability and acceptability profile , NaPico + MgCit would appear as the most suitable regimen for bowel preparation in children .

###25274978
BACKGROUND	We estimated the prevalence and incidence of 14 human papillomavirus ( HPV ) types ( 6/11/16 / 18/31/33 / 35/39/45 / 51/52/56 / 58/59 ) in cervicovaginal swabs , and the attribution of these HPV types in cervical intraepithelial neoplasia ( CIN ) , and adenocarcinoma in situ ( AIS ) , using predefined algorithms that adjusted for multiple-type infected lesions .
METHODS	A total of 10,656 women ages 15 to 26 years and 1,858 women ages 24 to 45 years were enrolled in the placebo arms of one of three clinical trials of a quadrivalent HPV vaccine .
METHODS	We estimated the cumulative incidence of persistent infection and the proportion of CIN/AIS attributable to individual carcinogenic HPV genotypes , as well as the proportion of CIN/AIS lesions potentially preventable by a prophylactic 9-valent HPV6/11/16 / 18/31/33 / 45/52/58 vaccine .
RESULTS	The cumulative incidence of persistent infection with 1 of the seven high-risk types included in the 9-valent vaccine was 29 % , 12 % , and 6 % for women ages 15 to 26 , 24 to 34 , and 35 to 45 years , respectively .
RESULTS	A total of 2,507 lesions were diagnosed as CIN or AIS by an expert pathology panel .
RESULTS	After adjusting for multiple-type infected lesions , among women ages 15 to 45 years , these seven high-risk types were attributed to 43 % to 55 % of CIN1 , 70 % to 78 % of CIN2 , 85 % to 91 % of CIN3 , and 95 % to 100 % of AIS lesions , respectively .
RESULTS	The other tested types ( HPV35/39/51 / 56/59 ) were attributed to 23 % to 30 % of CIN1 , 7 % to 14 % of CIN2 , 3 % to 4 % of CIN3 , and 0 % of AIS lesions , respectively .
CONCLUSIONS	Approximately 85 % or more of CIN3/AIS , > 70 % CIN2 , and approximately 50 % of CIN1 lesions worldwide are attributed to HPV6/11/16 / 18/31/33 / 45/52/58 .
CONCLUSIONS	If 9-valent HPV vaccination programs are effectively implemented , the majority of CIN2 and CIN3 lesions worldwide could be prevented , in addition to approximately one-half of CIN1 .

###24882434
BACKGROUND	Maintenance monotherapy with the PARP inhibitor olaparib significantly prolonged progression-free survival ( PFS ) versus placebo in patients with platinum-sensitive recurrent serous ovarian cancer .
BACKGROUND	We aimed to explore the hypothesis that olaparib is most likely to benefit patients with a BRCA mutation .
METHODS	We present data from the second interim analysis of overall survival and a retrospective , preplanned analysis of data by BRCA mutation status from our randomised , double-blind , phase 2 study that assessed maintenance treatment with olaparib 400 mg twice daily ( capsules ) versus placebo in patients with platinum-sensitive recurrent serous ovarian cancer who had received two or more platinum-based regimens and who had a partial or complete response to their most recent platinum-based regimen .
METHODS	Randomisation was by an interactive voice response system , stratified by time to progression on penultimate platinum-based regimen , response to the most recent platinum-based regimen before randomisation , and ethnic descent .
METHODS	The primary endpoint was PFS , analysed for the overall population and by BRCA status .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00753545 .
RESULTS	Between Aug 28 , 2008 , and Feb 9 , 2010 , 136 patients were assigned to olaparib and 129 to placebo .
RESULTS	BRCA status was known for 131 ( 96 % ) patients in the olaparib group versus 123 ( 95 % ) in the placebo group , of whom 74 ( 56 % ) versus 62 ( 50 % ) had a deleterious or suspected deleterious germline or tumour BRCA mutation .
RESULTS	Of patients with a BRCA mutation , median PFS was significantly longer in the olaparib group than in the placebo group ( 112 months [ 95 % CI 83-not calculable ] vs 43 months [ 30-54 ] ; HR 018 [ 010-031 ] ; p < 00001 ) ; similar findings were noted for patients with wild-type BRCA , although the difference between groups was lower ( 74 months [ 55-103 ] vs 55 months [ 37-56 ] ; HR 054 [ 034-085 ] ; p = 00075 ) .
RESULTS	At the second interim analysis of overall survival ( 58 % maturity ) , overall survival did not significantly differ between the groups ( HR 088 [ 95 % CI 064-121 ] ; p = 044 ) ; similar findings were noted for patients with mutated BRCA ( HR 073 [ 045-117 ] ; p = 019 ) and wild-type BRCA ( HR 099 [ 063-155 ] ; p = 096 ) .
RESULTS	The most common grade 3 or worse adverse events in the olaparib group were fatigue ( in ten [ 7 % ] patients in the olaparib group vs four [ 3 % ] in the placebo group ) and anaemia ( seven [ 5 % ] vs one [ < 1 % ] ) .
RESULTS	Serious adverse events were reported in 25 ( 18 % ) patients who received olaparib and 11 ( 9 % ) who received placebo .
RESULTS	Tolerability was similar in patients with mutated BRCA and the overall population .
CONCLUSIONS	These results support the hypothesis that patients with platinum-sensitive recurrent serous ovarian cancer with a BRCA mutation have the greatest likelihood of benefiting from olaparib treatment .
BACKGROUND	AstraZeneca .

###25880911
BACKGROUND	Lifestyle factors represent prime targets for behaviour change interventions to promote healthy ageing and reduce dementia risk .
BACKGROUND	We evaluated a goal-setting intervention aimed at promoting increased cognitive and physical activity and improving mental and physical fitness , diet and health .
METHODS	This was a pilot randomised controlled trial designed to guide planning for a larger-scale investigation , provide preliminary evidence regarding efficacy , and explore feasibility and acceptability .
METHODS	Primary outcomes were engagement in physical and cognitive activity .
METHODS	Participants aged over 50 living independently in the community were recruited through a community Agewell Centre .
METHODS	Following baseline assessment participants were randomly allocated to one of three conditions : control ( IC ) had an interview in which information about activities and health was discussed ; goal-setting ( GS n = 24 ) had an interview in which they set behaviour change goals relating to physical , cognitive and social activity , health and nutrition ; and goal-setting with mentoring ( GM , n = 24 ) had the goal-setting interview followed by bi-monthly telephone mentoring .
METHODS	Participants and researchers were blinded to group assignment .
METHODS	Participants were reassessed after 12months .
RESULTS	Seventy-five participants were randomised ( IC n = 27 , GS n = 24 , GM n = 24 ) .
RESULTS	At 12-month follow-up , the two goal-setting groups , taken together ( GS n = 21 , GM n = 22 ) , increased their level of physical ( effect size 0.37 ) and cognitive ( effect size 0.15 ) activity relative to controls ( IC n = 27 ) .
RESULTS	In secondary outcomes , the two goal-setting groups taken together achieved additional benefits compared to control ( effect sizes0 .2 ) in memory , executive function , cholesterol level , aerobic capacity , flexibility , balance , grip strength , and agility .
RESULTS	Adding follow-up mentoring produced further benefits compared to goal-setting alone ( effect sizes0 .2 ) in physical activity , body composition , global cognition and memory , but not in other domains .
RESULTS	Implementation of the recruitment procedure , assessment and intervention was found to be feasible and the approach taken was acceptable to participants , with no adverse effects .
CONCLUSIONS	A brief , low-cost goal-setting intervention is feasible and acceptable , and has the potential to achieve increased activity engagement .
BACKGROUND	Current Controlled Trials ISRCTN30080637 .

###24873159
OBJECTIVE	To investigate the effectiveness of surgical strategies for Shang Ring circumcision in the treatment of short frenulum praeputii in patients with redundant prepuce or phimosis .
METHODS	Totally , 130 cases of short frenulum praeputii with redundant prepuce or phimosis were randomly assigned to an experimental group and a control group of equal number to receive Shang Ring circumcision , the former by transverse incision in the distal penis foreskin and pull-up of the interior board , and the latter by conventional transverse incision and longitudinal suture of the frenulum praeputii .
METHODS	Comparisons were made between the two groups in the surgical duration , intraoperative blood loss , 24 h postoperative pain visual analog score ( VAS ) , postoperative complications , satisfaction with the penile appearance , and the quality of sexual life .
RESULTS	The surgical duration , intraoperative blood loss , 24 h postoperative VAS , postoperative sexual satisfaction , and satisfaction with penile appearance were ( 4.60 + / - 1.20 ) min , ( 2.61 + / - 1.81 ) ml , 1.73 + / - 0.76 , 98.5 % , and 98.5 % , respectively , in the experimental group , as compared with ( 21.60 + / - 6.30 ) min , ( 11.10 + / - 3.40 ) ml , 5.37 + / - 1.84 , 70.3 % and 69.8 % in the control , with statistically significant differences between the two groups ( P < 0.05 ) .
RESULTS	The incidence rates of such major complications as wound dehiscence , infection , and moderate to severe edema were 1.5 % ( 1/65 ) , 3.1 % ( 2/65 ) , and 4.6 % ( 3/65 ) , respectively , in the experimental group in comparison with 12.3 % ( 8/65 ) , 15.3 % ( 10/65 ) , and 30.7 % ( 20/65 ) in the control , with statistically significant differences between the two groups ( P < 0.05 ) .
RESULTS	None of patients had any serious complications .
CONCLUSIONS	Shang Ring circumcision by transverse incision in the distal penis foreskin and pull-up of the interior board , with its advantages of shorter operation time , less blood loss , mild pain , fewer complications , and higher satisfaction and acceptance of the patients , can be used as an safe and effective approach to the treatment of short frenulum praeputii .

###25370953
BACKGROUND	Acotiamide is a first-in-class drug that is used to treat functional dyspepsia ( FD ) .
BACKGROUND	It is considered that acotiamide acts as an antagonist on muscarinic autoreceptors in the enteric nervous system and inhibits acetylcholinesterase activity .
BACKGROUND	We examined the effect of acotiamide on gastric emptying in healthy adult humans .
METHODS	Twelve healthy adult males were enrolled in this double-blind crossover study .
METHODS	Acotiamide or placebo was administered orally in the 12 subjects 30min before ingestion of a nutritional liquid meal ( 400Kcal/400mL ) .
METHODS	Six of the 12 participants took 100mg of acotiamide or placebo , and six of the 12 participants took 300mg of acotiamide or placebo in a double-blind crossover fashion .
METHODS	All subjects underwent measurement of gastric emptying by the ( 13 ) C breath test .
RESULTS	After the meal with placebo was ingested , the % dose/h curve ascended .
RESULTS	The % dose/h curve after a meal with 100 or 300mg of acotiamide ascended in an identical manner compared with the results with placebo .
RESULTS	No significant differences were observed at any studied time point , and there were no significant changes in gastric emptying parameters ( gastric emptying coefficient , t-1 / 2ex and t-lag ex ) .
CONCLUSIONS	A single administration of 100 or 300mg of acotiamide did not affect gastric emptying after a liquid meal in healthy adult humans .
CONCLUSIONS	Acotiamide has profound effects on restoring delayed gastric emptying and impaired accommodation in patients with FD but may have no effect on gastric emptying in healthy subjects .
CONCLUSIONS	Such pharmacological actions have not been observed in previous gastroprokinetic studies .

###25842725
OBJECTIVE	To observe the influence of Qingrehuatan decoction ( QRHT ) on serum metabolic profile in young essential hypertension ( YEH ) patients with abundant phlegm-heat syndrome and provide a basis for treatment with the decoction .
METHODS	Twelve male YEH patients were randomly selected and serum samples were collected for examination before and after 4 weeks of the treatment with QRHT .
METHODS	Twelve healthy males were randomly selected and their serum samples were collected as a control .
METHODS	All serum samples were detected using metabolomic technology with 1H nuclear magnetic resonance .
METHODS	Differences in metabolites were studied by principal component analysis and partial least squares-discriminate analysis , which produced scores and loadings plots .
RESULTS	After 4 weeks of treatment , serum substances could be distinguished between the YEH patients with abundant phlegm-heat syndrome and the control patients .
RESULTS	The specific serum endog - enous metabolites tended to improve after the treatment .
RESULTS	QRHT can appropriately increase the levels of glucose , lactic acid , citric acid , high-density lipoprotein , phosphatidylcholine , glycerophosphate choline , hydroxybutyrate , alanine , and glutamate .
RESULTS	QRHT could also decrease the levels of low-density lipoprotein/very low-density lipoprotein , lipids , N-acetyl glycoprotein , and O-acetyl glycoprotein .
CONCLUSIONS	QRHT can effectively ameliorate metabolic disorders in YEH Patients with abundant phlegm-heat syndrome .
CONCLUSIONS	1H NMR-based metabolomic technology can provide an objective basis for the treatment of YEH patients with abundant phlegm-heat syndrome using QRHT .

###25294887
BACKGROUND	The EORTC-STBSG coordinated two large trials of adjuvant chemotherapy ( CT ) in localized high-grade soft tissue sarcoma ( STS ) .
BACKGROUND	Both studies failed to demonstrate any benefit on overall survival ( OS ) .
BACKGROUND	The aim of the analysis of these two trials was to identify subgroups of patients who may benefit from adjuvant CT. .
METHODS	Individual patient data from two EORTC trials comparing doxorubicin-based CT to observation only in completely resected STS ( large resection , R0/marginal resection , R1 ) were pooled .
METHODS	Prognostic factors were assessed by univariate and multivariate analyses .
METHODS	Patient outcomes were subsequently compared between the two groups of patients according to each analyzed factor .
RESULTS	A total of 819 patients had been enrolled with a median follow-up of 8.2 years .
RESULTS	Tumor size , high histological grade and R1 resection emerged as independent adverse prognostic factors for relapse-free survival ( RFS ) and OS .
RESULTS	Adjuvant CT is an independent favorable prognostic factor for RFS but not for OS .
RESULTS	A significant interaction between benefit of adjuvant CT and age , gender and R1 resection was observed for RFS and OS .
RESULTS	Males and patients > 40 years had a significantly better RFS in the treatment arms , while adjuvant CT was associated with a marginally worse OS in females and patients < 40 years .
RESULTS	Patients with R1 resection had a significantly better RFS and OS favoring adjuvant CT arms .
CONCLUSIONS	Adjuvant CT is not associated with a better OS in young patients or in any pathology subgroup .
CONCLUSIONS	Poor quality of initial surgery is the most important prognostic and predictive factor for utility of adjuvant CT in STS .
CONCLUSIONS	Based on these data , we conclude that adjuvant CT for STS remains an investigational procedure and is not a routine standard of care .

###24746358
OBJECTIVE	To assess the association between minimum inhibitory concentration ( MIC ) and clinical outcomes in a fungal keratitis clinical trial .
METHODS	Experimental study using data from a randomized comparative trial .
METHODS	Of the 323 patients enrolled in the trial , we were able to obtain MIC values from 221 patients with monocular fungal keratitis .
METHODS	The Mycotic Ulcer Treatment Trial I was a randomized , double-masked clinical trial comparing clinical outcomes of monotherapy with topical natamycin versus voriconazole for the treatment of fungal keratitis .
METHODS	Speciation and determination of MIC to natamycin and voriconazole were performed according to Clinical and Laboratory Standards Institute guidelines .
METHODS	The relationship between MIC and clinical outcome was assessed .
METHODS	The primary outcome was 3-month best spectacle-corrected visual acuity .
METHODS	Secondary outcomes included 3-month infiltrate or scar size ; corneal perforation and/or therapeutic penetrating keratoplasty ; and time to re-epithelialization .
RESULTS	A 2-fold increase in MIC was associated with a larger 3-month infiltrate or scar size ( 0.21 mm ; 95 % confidence interval [ CI ] , 0.10-0 .31 ; P < 0.001 ) and increased odds of perforation ( odds ratio , 1.32 ; 95 % CI , 1.04-1 .69 ; P = 0.02 ) .
RESULTS	No correlation was found between MIC and 3-month visual acuity .
RESULTS	For natamycin-treated cases , an association was found between higher natamycin MIC with larger 3-month infiltrate or scar size ( 0.29 mm ; 95 % CI , 0.15-0 .43 ; P < 0.001 ) and increased perforations ( odds ratio , 2.41 ; 95 % CI , 1.46-3 .97 ; P < 0.001 ) .
RESULTS	Among voriconazole-treated cases , the voriconazole MIC did not correlate with any of the measured outcomes in the study .
CONCLUSIONS	Decreased susceptibility to natamycin was associated with increased infiltrate or scar size and increased odds of perforation .
CONCLUSIONS	There was no association between susceptibility to voriconazole and outcome .

###25175842
BACKGROUND	The aim of this study was to evaluate the effects of topical ropivacaine anesthesia on hemodynamic responses during intubation and extubation of hypertensive patients .
METHODS	One hundred fifty patients with hypertension ASA II-III were scheduled for noncardiac operations .
METHODS	Patients were divided into 3 groups : a control group receiving 5 ml saline , and 2 groups receiving topical anesthesia with 100 mg lidocaine or 37.5 mg ropivacaine .
METHODS	Hemodynamic responses , including blood pressure and heart rate ( HR ) , were recorded at baseline ( T0 ) , before intubation ( T1 ) , during tracheal intubation ( T2 ) , 2 min after intubation ( T3 ) , upon eye opening on verbal commands ( T4 ) , during tracheal extubation ( T5 ) , and 2 min after extubation ( T6 ) .
METHODS	Patients were injected with urapidil 5 mg during intubation and extubation if their systolic blood pressure ( SBP ) was 160 mmHg or diastolic blood pressure ( DBP ) was 90 mmHg , and esmolol 10 mg when HR was 90 bpm .
RESULTS	During extubation , the total dosages of urapidil and esmolol were significantly higher in the saline than in the lidocaine or ropivacaine groups , and were significantly lower in the ropivacaine than in the lidocaine group .
RESULTS	At T2 , SBP , SBP , MAP , and HR were lower in the lidocaine and ropivacaine groups than in the saline group , but the differences were not significant .
RESULTS	From T4 to T6 , SBP , DBP , MAP , and HR were significantly lower in the ropivacaine group than in the other 2 groups ( P < 0.05 each ) .
CONCLUSIONS	Topical lidocaine and ropivacaine anesthesia can effectively reduce hemodynamic responses during intubation , with ropivacaine better at inhibiting hemodynamic changes at emergence in hypertensive patients .

###24874893
OBJECTIVE	Adalimumab has been shown to be effective and well tolerated in patients with Crohn 's disease .
OBJECTIVE	This analysis reports the results of a cohort of Japanese patients with moderate to severe Crohn 's disease who were evaluated for up to 3years to assess the long-term use of adalimumab .
METHODS	The study consisted of a double-blind part and an open-label part .
METHODS	Patients were included either in the 52-week double-blind , placebo-controlled part of the study followed by a 96-week open-label extension or in the open-label part from the beginning or in the event of a flare .
METHODS	Patients were treated with adalimumab and evaluated for up to 148weeks as 3 data cohorts : the all-adalimumab cohort ( patients receiving 1 injection of adalimumab ) , the 148-week follow-up subcohort ( patients who completed 148weeks of follow-up after the first adalimumab dose ) , and the dose-escalation subcohort ( patients receiving adalimumab doses that increased to 80mg every other week ) .
RESULTS	In the all-adalimumab cohort ( n = 79 ) , clinical remission rates were approximately 30 % after 36weeks of exposure to adalimumab and for the remainder of the study ( 35 % , 33 % , and 28 % for weeks 48 , 108 , and 144 , respectively ) .
RESULTS	An improvement in quality of life was also maintained over the same period .
RESULTS	In the dose-escalation subcohort ( n = 40 ) , the clinical remission rate was 75 % ( 6/8 ) 48weeks after dose escalation .
RESULTS	Adalimumab was tolerated , and no deaths were reported .
CONCLUSIONS	Adalimumab is effective for maintaining long-term clinical remission in Japanese patients with moderate to severe Crohn 's disease ( NCT00445432 ) .

###24284287
BACKGROUND	Melioidosis , an infectious disease caused by the Gram-negative bacillus Burkholderia pseudomallei , is difficult to cure .
BACKGROUND	Antimicrobial treatment comprises intravenous drugs for at least 10 days , followed by oral drugs for at least 12 weeks .
BACKGROUND	The standard oral regimen based on trial evidence is trimethoprim-sulfamethoxaxole ( TMP-SMX ) plus doxycycline .
BACKGROUND	This regimen is used in Thailand but is associated with side-effects and poor adherence by patients , and TMP-SMX alone is recommended in Australia .
BACKGROUND	We compared the efficacy and side-effects of TMP-SMX with TMP-SMX plus doxycycline for the oral phase of melioidosis treatment .
METHODS	For this multi-centre , double-blind , non-inferiority , randomised placebo-controlled trial , we enrolled patients ( aged 15 years ) from five centres in northeast Thailand with culture-confirmed melioidosis who had received a course of parenteral antimicrobial drugs .
METHODS	Using a computer-generated sequence , we randomly assigned patients to receive TMP-SMX plus placebo or TMP-SMX plus doxycycline for 20 weeks ( 1:1 ; block size of ten , stratified by study site ) .
METHODS	We followed patients up every 4 months for 1 year and annually thereafter to the end of the study .
METHODS	The primary endpoint was culture-confirmed recurrent melioidosis , and the non-inferiority margin was a hazard ratio ( HR ) of 1.7 .
METHODS	This study is registered with www.controlled-trials.com , number ISRCTN86140460 .
RESULTS	We enrolled and randomly assigned 626 patients : 311 to TMP-SMX plus placebo and 315 to TMP-SMX plus doxycycline .
RESULTS	16 patients ( 5 % ) in the TMP-SMX plus placebo group and 21 patients ( 7 % ) in the TMP-SMX plus doxycycline group developed culture-confirmed recurrent melioidosis ( HR 0.81 ; 95 % CI 0.42-1 .55 ) .
RESULTS	The criterion for non-inferiority was met ( p = 0.01 ) .
RESULTS	Adverse drug reactions were less common in the TMP-SMX plus placebo group than in the TMP-SMX plus doxycycline group ( 122 [ 39 % ] vs 167 [ 53 % ] ) .
CONCLUSIONS	Our findings suggest that TMP-SMX is not inferior to TMP-SMX plus doxycycline for the oral phase of melioidosis treatment , and is preferable on the basis of safety and tolerance by patients .
BACKGROUND	Thailand Research Fund , the Melioidosis Research Center , the Center of Excellence in Specific Health Problems in Greater Mekong Sub-region cluster , and the Wellcome Trust .

###24493829
OBJECTIVE	Concomitant genetic alterations could account for transient clinical responses to tyrosine kinase inhibitors of the EGF receptor ( EGFR ) in patients harboring activating EGFR mutations .
METHODS	We have evaluated the impact of pretreatment somatic EGFR T790M mutations , TP53 mutations , and Bcl-2 interacting mediator of cell death ( BCL2L11 , also known as BIM ) mRNA expression in 95 patients with EGFR-mutant non-small-cell lung cancer ( NSCLC ) included in the EURTAC trial ( trial registration : NCT00446225 ) .
RESULTS	T790M mutations were detected in 65.26 % of patients using our highly sensitive method based on laser microdissection and peptide-nucleic acid-clamping PCR , which can detect the mutation at an allelic dilution of 1 in 5,000 .
RESULTS	Progression-free survival ( PFS ) to erlotinib was 9.7 months for those with T790M mutations and 15.8 months for those without , whereas among patients receiving chemotherapy , it was 6 and 5.1 months , respectively ( P < 0.0001 ) .
RESULTS	PFS to erlotinib was 12.9 months for those with high and 7.2 months for those with low/intermediate BCL2L11 expression levels , whereas among chemotherapy-treated patients , it was 5.8 and 5.5 months , respectively ( P = 0.0003 ) .
RESULTS	Overall survival was 28.6 months for patients with high BCL2L11 expression and 22.1 months for those with low/intermediate BCL2L11 expression ( P = 0.0364 ) .
RESULTS	Multivariate analyses showed that erlotinib was a marker of longer PFS ( HR = 0.35 ; P = 0.0003 ) , whereas high BCL2L11 expression was a marker of longer PFS ( HR = 0.49 ; P = 0.0122 ) and overall survival ( HR = 0.53 ; P = 0.0323 ) .
CONCLUSIONS	Low-level pretreatment T790M mutations can frequently be detected and can be used for customizing treatment with T790M-specific inhibitors .
CONCLUSIONS	BCL2L11 mRNA expression is a biomarker of survival in EGFR-mutant NSCLC and can potentially be used for synthetic lethality therapies .

###24419109
OBJECTIVE	Adjuvant chemotherapy improves patient survival rates after resection for pancreatic adenocarcinoma , but the optimal duration and time to initiate chemotherapy is unknown .
METHODS	Patients with pancreatic ductal adenocarcinoma treated within the international , phase III , European Study Group for Pancreatic Cancer-3 ( version 2 ) study were included if they had been randomly assigned to chemotherapy .
METHODS	Overall survival analysis was performed on an intention-to-treat basis , retaining patients in their randomized groups , and adjusting the overall treatment effect by known prognostic variables as well as the start time of chemotherapy .
RESULTS	There were 985 patients , of whom 486 ( 49 % ) received gemcitabine and 499 ( 51 % ) received fluorouracil ; 675 patients ( 68 % ) completed all six cycles of chemotherapy ( full course ) and 293 patients ( 30 % ) completed one to five cycles .
RESULTS	Lymph node involvement , resection margins status , tumor differentiation , and completion of therapy were all shown by multivariable Cox regression to be independent survival factors .
RESULTS	Overall survival favored patients who completed the full six courses of treatment versus those who did not ( hazard ratio [ HR ] , 0.516 ; 95 % CI , 0.443 to 0.601 ; P < .001 ) .
RESULTS	Time to starting chemotherapy did not influence overall survival rates for the full study population ( HR , 0.985 ; 95 % CI , 0.956 to 1.015 ) .
RESULTS	Chemotherapy start time was an important survival factor only for the subgroup of patients who did not complete therapy , in favor of later treatment ( P < .001 ) .
CONCLUSIONS	Completion of all six cycles of planned adjuvant chemotherapy rather than early initiation was an independent prognostic factor after resection for pancreatic adenocarcinoma .
CONCLUSIONS	There seems to be no difference in outcome if chemotherapy is delayed up to 12 weeks , thus allowing adequate time for postoperative recovery .

###25985386
OBJECTIVE	In acute respiratory failure patients undergoing pressure support ventilation , a short cyclic recruitment maneuver ( Sigh ) might induce reaeration of collapsed lung regions , possibly decreasing regional lung strain and improving the homogeneity of ventilation distribution .
OBJECTIVE	We aimed to describe the regional effects of different Sigh rates on reaeration , strain , and ventilation heterogeneity , as measured by thoracic electrical impedance tomography .
METHODS	Prospective , randomized , cross-over study .
METHODS	General ICU of a single university-affiliated hospital .
METHODS	We enrolled 20 critically ill patients intubated and mechanically ventilated with PaO2/FIO2 up to 300mm Hg and positive end-expiratory pressure at least 5cm H2O ( 15 with acute respiratory distress syndrome ) , undergoing pressure support ventilation as per clinical decision .
METHODS	Sigh was added to pressure support ventilation as a 35cm H2O continuous positive airway pressure period lasting 3-4 seconds at different rates ( no-Sigh vs 0.5 , 1 , and 2 Sigh ( s ) / min ) .
METHODS	All study phases were randomly performed and lasted 20 minutes .
RESULTS	In the last minutes of each phase , we measured arterial blood gases , changes in end-expiratory lung volume of nondependent and dependent regions , tidal volume reaching nondependent and dependent lung ( Vtnondep and Vtdep ) , dynamic intratidal ventilation heterogeneity , defined as the average ratio of Vt reaching nondependent/Vt reaching dependent lung regions along inspiration ( VtHit ) .
RESULTS	With Sigh , oxygenation improved ( p < 0.001 vs no-Sigh ) , end-expiratory lung volume of nondependent and dependent regions increased ( p < 0.01 vs no-Sigh ) , Vtnondep showed a trend to reduction , and Vtdep significantly decreased ( p = 0.11 and p < 0.01 vs no-Sigh , respectively ) .
RESULTS	VtHit decreased only when Sigh was delivered at 0.5 / min ( p < 0.05 vs no-Sigh ) , while it did not vary during the other two phases .
CONCLUSIONS	Sigh decreases regional lung strain and intratidal ventilation heterogeneity .
CONCLUSIONS	Our study generates the hypothesis that in ventilated acute respiratory failure patients , Sigh may enhance regional lung protection .

###25174484
OBJECTIVE	To investigate the interactive effects between batroxobin and low molecular weight heparin ( LMWH ) in reducing peri-operative blood loss and coagulation function in patients who undergone the total hip replacement surgery .
METHODS	240 ASA I - III patients received 4 000 IU LMWH 12 hours preoperatively before undergoing the total hip replacement operation , were randomly divided into two groups : testing group ( Group A , n = 120 ) and control group ( Group B , n = 120 ) receiving 2 U batroxobin or 50 mg mannitol 10 minutes before incision respectively .
METHODS	Perioperative blood loss , postoperative 24 hours drainage and blood routine test , prothrombin time ( PT ) , activated partial thromboplastin time ( APTT ) and fibrinogen ( FIB ) were measured respectively .
METHODS	Deep vein thrombosis ( DVT ) were measured through color Doppler B-ultrasound 3 days after the operation .
RESULTS	The perioperative blood loss in Group A ( 422.64 ml ) was less than that in Group B ( 667.67 ml ) ( P < 0.01 ) while red blood cell , hemoglobin , red blood cell volume and platelet were decreasing after operation in both groups but no significant difference was found between the two groups ( P > 0.05 ) .
RESULTS	There were no drug-related adverse effects found in the two groups , neither the difference in hospitalization between the two groups ( P > 0.05 ) .
CONCLUSIONS	Batroxobin ( 2 U ) could reduce the perioperative blood loss in patients with LMWH who had undergone the total hip replacement operation but did not show adverse effect on DVT .

###24787916
BACKGROUND	With predicted increases in dementia incidence , interventions targeting neuroplasticity and neuroprotection are required .
BACKGROUND	Cognitive Training ( CT ) is an intervention which has been shown to improve aspects of cognition , but the pathophysiological mechanisms contributing to its efficacy are unknown .
OBJECTIVE	We aimed to explore the neurobiological correlates of CT using Mismatch Negativity ( MMN ) , a neurophysiological marker of pre-attentive information processing , which in turn , is postulated to underpin higher-order cognitive processes .
METHODS	As part of a larger randomized controlled trial , forty ` at risk ' ( i.e. , mild cognitive impairment or late-life depression ) participants aged 51-79 years underwent neurophysiological , neuropsychological , and psychiatric assessments before and after a multi-faceted seven-week CT program or a ` treatment-as-usual ' seven-week waitlist period .
RESULTS	The treatment group demonstrated significantly increased fronto-central MMN responses ( p < 0.05 ) , as well as improved phonemic verbal fluency ( p < 0.05 ) and decreased self-rated memory difficulties ( p < 0.05 ) following CT , in comparison to the waitlist control group .
RESULTS	However , there were no significant correlations between enhanced MMN and cognitive/psychosocial outcomes .
CONCLUSIONS	Results from this preliminary investigation indicate that CT is associated with enhanced neurophysiological mechanisms suggestive of improved pre-attentive processing , which may reflect alterations in underlying neurobiology .
CONCLUSIONS	Further research is warranted to confirm these findings , to explicate whether CT is associated with restorative or compensatory neuroplastic processes and to determine whether MMN is a useful biomarker for treatment response .

###24238317
OBJECTIVE	Children with gastroenteritis often develop dehydration with metabolic acidosis .
OBJECTIVE	Serum ketones are frequently elevated in this population .
OBJECTIVE	The goal was to determine the relationship between initial serum ketone concentration and both the degree of dehydration and the magnitude of acidosis .
METHODS	This was a secondary analysis of a prospective trial of crystalloid administration for rapid rehydration .
METHODS	Children 6 months to 6 years of age with gastroenteritis and dehydration were enrolled .
METHODS	A point-of-care serum ketone ( beta-hydroxybutyrate ) concentration was obtained at the time of study enrollment .
METHODS	The relationship between initial serum ketone concentration and a prospectively assigned and previously validated clinical dehydration score , and serum bicarbonate concentration , was analyzed .
RESULTS	A total of 188 patients were enrolled .
RESULTS	The median serum ketone concentration was elevated at 3.1 mmol/L ( interquartile range [ IQR ] = 1.2 to 4.6 mmol/L ) , and the median dehydration score was consistent with moderate dehydration .
RESULTS	A significant positive relationship was found between serum ketone concentration and the clinical dehydration score ( Spearman 's rho = 0.22 , p = 0.003 ) .
RESULTS	Patients with moderate dehydration had a higher median serum ketone concentration than those with mild dehydration ( 3.6 mmol/L vs. 1.4 mmol/L , p = 0.007 ) .
RESULTS	Additionally , the serum ketone concentration was inversely correlated with serum bicarbonate concentration ( = -0.26 , p < 0.001 ) .
CONCLUSIONS	Children with gastroenteritis and dehydration have elevated serum ketone concentrations that correlate with both degree of dehydration and magnitude of metabolic acidosis .
CONCLUSIONS	Point-of-care serum ketone measurement may be a useful tool to inform management decisions at the point of triage or in the initial evaluation of children with gastroenteritis and dehydration .

###25082605
OBJECTIVE	In this secondary analysis of results of the Clinical Outcomes in MEasurement-Based Treatment ( COMET ) trial , patient behaviors that might account for the differences observed in clinical outcomes were examined .
METHODS	Patients ( N = 914 ) diagnosed as having major depressive disorder participated in telephone interviews either monthly for six months ( intervention ) or at three and six months ( usual care ) asking about antidepressant medication-taking , use of psychotherapy or counseling , and participation in depression support groups .
METHODS	Physicians ( N = 83 ) in the intervention arm received monthly feedback regarding their patients ' depression severity .
RESULTS	A total of 664 ( 73 % ) patients completed the month 6 interview .
RESULTS	The adjusted odds of current antidepressant use at six months were 85 % greater ( p = .01 ) for patients in the intervention ( N = 380 ) versus usual care ( N = 284 ) arms , according to multivariate regression analyses .
CONCLUSIONS	More frequent measurement of depression symptoms was associated with greater medication persistence , which in turn may have mediated clinical improvements .

###24708195
OBJECTIVE	To explore whether psychosocial challenges impact effects of vocational rehabilitation in Veterans with Posttraumatic Stress Disorder ( PTSD ) .
METHODS	A post hoc exploratory analysis of possible moderators of treatment was conducted on outcomes from a randomized , controlled trial of Individual Placement and Support in Veterans with PTSD .
RESULTS	When examining groups within each moderator , there was a greater IPS supportive employment benefit in gaining competitive employment for those with inadequate transportation ( number needed to treat [ NNT ] = 1.5 ) and inadequate housing ( NNT = 1.5 ) compared with the main finding of the pilot study ( NNT = 2.07 ) .
RESULTS	Compared with the main finding of the pilot study , there was no greater advantage of IPS for those with adequate transportation ( NNT = 2.4 ) or adequate housing ( NNT = 2.4 ) .
RESULTS	Compared with the main finding in the pilot study , those without a family care burden had a greater benefit from IPS ( NNT = 1.4 ) and those with family care burden had a reduced treatment effect ( NNT = 3.3 ) .
CONCLUSIONS	These results are exploratory and are not intended to guide clinical decision-making , but rather offer a potentially useful strategy in the design of larger trials of IPS .

###25868758
OBJECTIVE	To determine the effects of keratocyte loss on optical properties and vision after laser in situ keratomileusis ( LASIK ) with the flap created with a femtosecond laser or a mechanical microkeratome .
METHODS	Randomized clinical paired-eye study .
METHODS	Both eyes of 21 patients received LASIK for myopia or myopic astigmatism .
METHODS	One eye of each patient was randomized by ocular dominance to flap creation with a femtosecond laser and the other eye to flap creation with a mechanical microkeratome .
METHODS	Before LASIK and at 1 , 3 , and 6 months and 1 , 3 , and 5 years after LASIK , keratocyte density was measured using confocal microscopy , and high-contrast visual acuity and anterior corneal wavefront aberrations were measured by standard methods .
METHODS	At each visit , all variables were compared between methods of creating the flap and to the same variable before treatment using paired tests with Bonferroni correction for multiple comparisons .
RESULTS	Keratocyte density in the flap decreased by 20 % during the first year after LASIK and remained low through 5 years ( P < .001 ) .
RESULTS	High-order wavefront aberrations increased and uncorrected visual acuity improved immediately after surgery , but these variables did not change further to 5 years .
RESULTS	There were no differences in any variables between treatments .
CONCLUSIONS	A sustained reduction in keratocyte density does not affect vision or optical properties of the cornea through 5 years after LASIK .
CONCLUSIONS	The method of creating a LASIK flap does not influence the changes in keratocyte density in the flap .

###24986785
BACKGROUND	Many with alcohol and other drug dependence have concurrent marijuana use , yet it is not clear how to address it during addiction treatment .
BACKGROUND	This is partially due to the lack of clarity about whether marijuana use impacts one 's ability to achieve abstinence from the target of addiction treatment .
BACKGROUND	We examined the association between marijuana use and abstinence from other substances among individuals with substance dependence .
METHODS	A secondary analysis of the Addiction Health Evaluation And Disease management study , a randomized trial testing the effectiveness of chronic disease management .
METHODS	Individuals met criteria for drug or alcohol dependence and reported recent drug ( i.e. opioid or stimulant ) or heavy alcohol use .
METHODS	Recruitment occurred largely at an inpatient detoxification unit , and all participants were referred to primary medical care .
METHODS	The association between marijuana use and later abstinence from drug and heavy alcohol use was assessed using longitudinal multivariable models .
RESULTS	Of 563 study participants , 98 % completed at least one follow-up assessment and 535 ( 95 % ) had at least one pair of consecutive assessments and were included .
RESULTS	In adjusted analyses , marijuana use was associated with a 27 % reduction in the odds of abstinence from drug and heavy alcohol use ( adjusted odds ratio 0.73 [ 95 % CI , 0.56-0 .97 ] , P = 0.03 ) .
CONCLUSIONS	Marijuana use among individuals with alcohol or other drug dependence is associated with a lower odds of achieving abstinence from drug and heavy alcohol use .
CONCLUSIONS	These findings add evidence that suggests concomitant marijuana use among patients with addiction to other drugs merits attention from clinicians .

###26122803
OBJECTIVE	Delayed cord clamping ( DCC ) is recommended for premature infants to improve blood volume .
OBJECTIVE	Most preterm infants are born by cesarean delivery ( CD ) , and placental transfusion may be less effective than in vaginal delivery ( VD ) .
OBJECTIVE	We sought to determine whether infants < 32 weeks born by CD who undergo umbilical cord milking ( UCM ) have higher measures of systemic blood flow than infants who undergo DCC .
METHODS	This was a 2-center trial .
METHODS	Infants delivered by CD were randomly assigned to undergo UCM or DCC .
METHODS	Infants delivered by VD were also randomly assigned separately .
METHODS	UCM ( 4 strippings ) or DCC ( 45-60 seconds ) were performed .
METHODS	Continuous hemodynamic measurements and echocardiography were done at site 1 .
RESULTS	A total of 197 infants were enrolled ( mean gestational age 28 2 weeks ) .
RESULTS	Of the 154 infants delivered by CD , 75 were assigned to UCM and 79 to DCC .
RESULTS	Of the infants delivered by CD , neonates randomly assigned to UCM had higher superior vena cava flow and right ventricular output in the first 12 hours of life .
RESULTS	Neonates undergoing UCM also had higher hemoglobin , delivery room temperature , blood pressure over the first 15 hours , and urine output in the first 24 hours of life .
RESULTS	There were no differences for the 43 infants delivered by VD .
CONCLUSIONS	This is the first randomized controlled trial demonstrating higher systemic blood flow with UCM in preterm neonates compared with DCC .
CONCLUSIONS	UCM may be a more efficient technique to improve blood volume in premature infants delivered by CD .

###25772212
OBJECTIVE	The objective of the study was to evaluate the effectiveness of a high-fidelity birth simulator ( Noelle ; Gaumard Scientific , Coral Gables , FL ) compared with a lower-cost , low-tech , birth simulator ( MamaNatalie ; Laerdal Medical , Stavanger , Norway ) in teaching medical students how to perform a spontaneous vaginal delivery ( SVD ) .
METHODS	Prior to the obstetrics-gynecology clerkship , students were randomly assigned to 2 groups .
METHODS	The MamaNatalie group ( MG ) completed 45 minutes of SVD simulation using an obstetrical abdominal-pelvic model worn by an obstetrics-gynecology faculty member .
METHODS	The Noelle group ( NG ) completed 45 minutes of SVD simulation using a high-fidelity , computer-controlled mannequin facilitated by an obstetrics-gynecology faculty member .
METHODS	The primary outcome was student performance during his or her first SVD as rated by supervising preceptors .
METHODS	Surveys were also completed by students on confidence in performing steps of a SVD ( secondary outcome ) .
RESULTS	One hundred ten medical students ( 95 % of those eligible ) participated in this research study .
RESULTS	The final postclerkship survey was completed by 93 students ( 85 % follow-up rate ) .
RESULTS	There were no significant differences in performance of SVD steps between MG and NG students as rated by preceptors .
RESULTS	The SVD step with the least involvement by students was controlling the head ( 20.5 % in MG , 23.3 % in NG performed step with hands-off supervision ) .
RESULTS	Delivery of the placenta was the SVD step with the most involvement ( 65.9 % in MG , 52.3 % in NG performed step with hands-off supervision ) .
RESULTS	Baseline presimulation confidence levels were similar between MG and NG .
RESULTS	On the immediate postsimulation survey of confidence , MG students were significantly more confident in their ability to deliver the abdomen and legs and perform fundal massage with hands-off supervision ( P < .05 ) than NG students .
RESULTS	Following the clerkship , MG students were significantly more confident in their ability to control the head and deliver the abdomen and legs ( P < .05 ) than NG students .
CONCLUSIONS	MamaNatalie is as effective as Noelle in training medical students how to perform a SVD and may be a useful , lower-cost alternative in teaching labor and delivery skills to novice learners .
CONCLUSIONS	Because birth simulation interventions involve both a simulation model and facilitator , research is required to further determine the effect of human interaction on learning outcomes .

###24767603
BACKGROUND	Worldwide prevalence of generalized anxiety disorder ( GAD ) is considered high ; in Europe lifetime prevalence has been estimated at 4.3 to 5.9 % .
BACKGROUND	High levels of anxiety disorders have been reported in university students , affecting 25 to 30 % of the population .
BACKGROUND	Young adults are some of the most vulnerable for the onset of mental health disorders and any stressors may act as a catalyst for their onset .
BACKGROUND	The absence of resources can often mean that many do not seek treatment .
BACKGROUND	Other factors that impede access to resources include such things as a lack of trained professionals , personal stigma , and waiting lists .
BACKGROUND	Anxiety disorders can be treated successfully ; indeed brief forms of cognitive-behavior therapy have been recommended .
BACKGROUND	One potential avenue for research and development is that of delivering low-intensity interventions online for students with GAD .
BACKGROUND	Therefore , the current study seeks to investigate the potential effectiveness for a low-intensity online CBT-based treatment for GAD in a service-based setting ; implemented as one step in a stepped-care model .
METHODS	The research is a service-based effectiveness study utilizing a randomized waiting-list controlled design .
METHODS	The active intervention consists of six weekly modules of online CBT .
METHODS	Participants are assigned a supporter who provides weekly post-session feedback on progress and exercises .
METHODS	Participants will complete the GAD-7 as the primary outcome measure .
METHODS	Secondary outcomes include pathological worry , depression and measures of well-being .
METHODS	At three-months follow-up data will be collected using the GAD-7 , BDI-II , PSWQ , ED-Q5 and WSAS .
METHODS	Post-session data will be collected on significant in-session events in treatment ( HAT ) .
METHODS	A satisfaction with treatment measure will be administered post-treatment ( SAT ) .
CONCLUSIONS	The study will be a contribution to the potential for a low-intensity internet-delivered program implemented in a service-based setting ; implemented as one step in a stepped-care model .
CONCLUSIONS	The study will be a contribution to the already established work in online treatments for anxiety worldwide .
CONCLUSIONS	The study will assess the utility of an innovative digital health solution ( SilverCloud ) to deliver such interventions .
BACKGROUND	Current Controlled Trials ISRCTN16303842 .

###25270609
OBJECTIVE	The aim of this study was to compare the effectiveness of single port/incision laparoscopic surgery ( SPILS ) with standard three-port laparoscopic surgery for appendicectomy in adults .
OBJECTIVE	Feasibility data was collected to evaluate generalizability to other single-port techniques such as cholecystectomy .
METHODS	This was a single-center , randomized controlled trial .
METHODS	Participants were randomized to receive either SPILS or standard three-port laparoscopic appendicectomy .
METHODS	The primary patient-reported outcomes were body image and cosmesis at 6 weeks .
METHODS	The primary clinical outcome was pain at 1-7 days .
METHODS	Secondary outcomes included duration of operation , conversion rates , complication rates , use of analgesia , hospital re-admission rates , re-operation rates , and time to return to normal activities .
RESULTS	Seventy-nine patients were randomized .
RESULTS	Sixty-seven completed the day 1-7 diary and 53 completed the 6-week follow-up .
RESULTS	SPILS patients answered significantly more favorably to the items in the body image scale [ mean ( SD ) 5.6 ( 1.0 ) vs. 7.0 ( 3.3 ) ; -1.4 ( 95 % CI -2.8 to 1.5 ; p = 0.03 ) ] and the cosmetic scale [ 18.9 ( 4.1 ) vs. 15.3 ( 5.8 ) ; 3.6 ( 95 % CI 0.7-6 .5 ; p = 0.016 ) ] compared with patients in the Standard group .
RESULTS	The duration of operation was shorter for SPILS , and patients required less morphine in recovery ; however , there were no statistically significant differences in other outcomes .
CONCLUSIONS	Patient-reported body image and cosmesis outcomes were better , and surgical outcomes were similar following SPILS .
CONCLUSIONS	However , the SPILS procedure is more technically demanding and may not be achievable or necessary in routine clinical care .
CONCLUSIONS	Further assessment of the findings is needed through larger multicenter studies .

###25976046
OBJECTIVE	To explore the protective effects of target blood glucose control on cardiac dysfunction in septic patients .
METHODS	For this prospective and randomized interventional study , a total of 90 septic patients were divided into group A ( blood glucose levels of 4.4 to 6.1 mmol/L ) , group B ( 6.1 to 8.3 mmol/L ) and group C ( 8.3 to 10.0 mmol/L ) ( n = 30 each ) .
METHODS	And 30 non-septic subjects were selected into control group .
METHODS	Serial transthoracic echocardiogram ( TTEs ) was performed to measure left ventricle ejection fraction ( LVEF ) and ratio of blood flow velocity of mitral annulus during early diastole ( E ) and atrial contraction ( A ) before and 1 , 3 , 7 days after blood glucose control with insulin therapy .
METHODS	The plasma level of brain natriuretic peptide ( BNP ) was detected by enzyme-linked immunosorbent assay ( ELISA ) .
METHODS	The patient records were reviewed to obtain information about demographics , Acute Physiology and Chronic Health Evaluation II ( APACHE II ) scores , incidence of hypoglycemia and 28-days survival rates .
RESULTS	No significant inter-group improvement existed in mean values of LVEFs ( P = 0.184 ) .
RESULTS	And E/As differed among the groups and there was statistical difference between groups A and C ( P = 0.005 ) .
RESULTS	There was a increasing trend for the levels of BNP of groups A , B and C. And comparison of group A with group B/C had statistical variability ( PAB = 0.028 , P ( Ac ) = 0.000 ) .
RESULTS	LVEFs had no variation ( P = 0.310 , P = 0.174 ) while E/A and BNP were significantly higher or lower in group A than those in others at Day 1 and 3 ( P = 0.005 ) .
RESULTS	The LVEFs were similar at Day 7 and E/As and BNPs of groups A , B and C showed statistical differences .
RESULTS	The variation of E/As with time differed between groups A , B and C.
CONCLUSIONS	Maintaining a target blood glucose of 4.4 to 6.1 mmol/L may improve cardiac dysfunction .
CONCLUSIONS	Furthermore , it has more significant improvement of diastolic dysfunction than systolic counterpart .
CONCLUSIONS	Combined utilization of LVEF , E/A and BNP is better in evaluating critical ill patients with sepsis-induced cardiomyopathy under target blood glucose control .
CONCLUSIONS	It suggests that a glucose level of 4.4 to 6.1 mmol/L may benefit cardiac consistent dysfunction in septic patients during 7 days after treatment .

###24460589
OBJECTIVE	The aim of this study was to examine non-cavitated approximal caries using non-invasive treatment methods .
METHODS	Molar and premolar teeth with approximal caries were used in this in vivo study .
METHODS	Approximal caries lesions were evaluated with visual and radiographic inspection and with the DIAGNOdent device .
METHODS	Five groups were formed to study non-invasive treatment , and each had at least 25 early approximal carious lesions .
METHODS	Patients in the control group were not treated .
METHODS	After the separation , either ozone application , acidulated phosphate fluoride gel , CPP-ACP-containing material ( Tooth Mousse ) , or an antibacterial bonding agent ( Clearfil Protect Bond ) was used .
METHODS	For 18 months after the non-invasive treatment , radiological controls were used to observe the progress of the initial and approximal caries in the 1st , 3rd , 6th and 12th months of follow-up .
METHODS	A Mann-Whitney U-test was used to perform the statistical analysis ; in-group comparisons were made with the Wilcoxon signed-rank test , and a quantitative assessment was performed using a chi-squared test .
RESULTS	At the end of 18 months , the caries lesions in the control group were observed to progress ( P < 0.01 ) .
RESULTS	The lesions that were scored as 1a during a visual inspection recovered by using non-invasive treatments .
CONCLUSIONS	Approximal caries lesions that were detected at the early stages remained stationary when using antibacterial agents and materials that promoted remineralisation .
CONCLUSIONS	Antibacterial agents and remineralisation materials can be used in treatment of early approximal caries lesions .

###25305567
BACKGROUND	Co-administration of an investigational quadrivalent meningococcal serogroups A , C , W and Y tetanus toxoid conjugate vaccine ( MenACWY-TT ) with the fourth dose of diphtheria-tetanus-acellular pertussis vaccine ( DTaP ) at age 15-18 months was investigated in 3-dose Haemophilus influenzae type b-meningococcal serogroups C/Y conjugate vaccine ( HibMenCY-TT ) - primed toddlers .
METHODS	Infants were randomized ( 5:1 ) and primed at 2 , 4 and 6 months of age with HibMenCY-TT and DTaP-hepatitis B-inactivated poliovirus ( DTaP-HBV-IPV ) vaccine , or Hib-TT and DTaP-HBV-IPV ( Control ) .
METHODS	HibMenCY-TT + DTaP-HBV-IPV vaccinees were re-randomized ( 2:2:1 ) to receive MenACWY-TT at 12-15 months and DTaP at 15-18 months ( MenACWY-TT group ) ; MenACWY-TT co-administered with DTaP at 15-18 months ( Coad group ) ; or HibMenCY-TT at 12-15 months and DTaP at 15-18 months ( HibMenCY-TT group ) .
METHODS	Controls received DTaP at 15-18 months .
METHODS	Only children in the HibMenCY-TT group received a fourth dose of Hib conjugate vaccine due to Hib conjugate vaccine shortage at the time of the study .
METHODS	DTaP immunogenicity and reactogenicity were assessed one month post-vaccination .
RESULTS	Pre-defined statistical non-inferiority criteria between Coad and Control groups were met for diphtheria , tetanus and filamentous haemagglutinin but not pertussis toxoid and pertactin .
RESULTS	Following vaccination 99 % of children had anti-diphtheria/anti-tetanus concentrations 1.0 IU/ml .
RESULTS	Pertussis GMCs were lower in all investigational groups versus Control .
RESULTS	In post hoc analyses , pertussis antibody concentrations were above those in infants following 3-dose DTaP primary vaccination in whom efficacy against pertussis was demonstrated ( Schmitt , von Knig , et al. , 1996 ; Schmitt , Schuind , et al. , 1996 ) .
RESULTS	The reactogenicity profile of the Coad group was similar to DTaP administered alone .
CONCLUSIONS	Routine booster DTaP was immunogenic with an acceptable safety profile when co-administered with MenACWY-TT vaccine in HibMenCY-TT-primed toddlers .
CONCLUSIONS	These data support the administration of a fourth DTaP dose following a 4-dose HibMenCY-TT vaccination series , or co-administered with MenACWY-TT in HibMenCY-TT-primed children .

###24247554
OBJECTIVE	Many patients with peripheral artery disease ( PAD ) have walking impairment despite therapy .
OBJECTIVE	Experimental studies in animals demonstrate improved perfusion in ischemic hind limb after mobilization of bone marrow progenitor cells ( PCs ) , but whether this is effective in patients with PAD is unknown .
OBJECTIVE	To investigate whether therapy with granulocyte-macrophage colony-stimulating factor ( GM-CSF ) improves exercise capacity in patients with intermittent claudication .
METHODS	In a phase 2 double-blind , placebo-controlled study , 159 patients ( median [ SD ] age , 64 [ 8 ] years ; 87 % male , 37 % with diabetes ) with intermittent claudication were enrolled at medical centers affiliated with Emory University in Atlanta , Georgia , between January 2010 and July 2012 .
METHODS	Participants were randomized ( 1:1 ) to received 4 weeks of subcutaneous injections of GM-CSF ( leukine ) , 500 g/day 3 times a week , or placebo .
METHODS	Both groups were encouraged to walk to claudication daily .
METHODS	The primary outcome was peak treadmill walking time ( PWT ) at 3 months .
METHODS	Secondary outcomes were PWT at 6 months and changes in circulating PC levels , ankle brachial index ( ABI ) , and walking impairment questionnaire ( WIQ ) and 36-item Short-Form Health Survey ( SF-36 ) scores .
RESULTS	Of the 159 patients randomized , 80 were assigned to the GM-CSF group .
RESULTS	The mean ( SD ) PWT at 3 months increased in the GM-CSF group from 296 ( 151 ) seconds to 405 ( 248 ) seconds ( mean change , 109 seconds [ 95 % CI , 67 to 151 ] ) and in the placebo group from 308 ( 161 ) seconds to 376 ( 182 ) seconds ( change of 56 seconds [ 95 % CI , 14 to 98 ] ) , but this difference was not significant ( mean difference in change in PWT , 53 seconds [ 95 % CI , -6 to 112 ] , P = .08 ) .
RESULTS	At 3 months , compared with placebo , GM-CSF improved the physical functioning subscore of the SF-36 questionnaire by 11.4 ( 95 % CI , 6.7 to 16.1 ) vs 4.8 ( 95 % CI , -0.1 to 9.6 ) , with a mean difference in change for GM-CSF vs placebo of 7.5 ( 95 % CI , 1.0 to 14.0 ; P = .03 ) .
RESULTS	Similarly , the distance score of the WIQ improved by 12.5 ( 95 % CI , 6.4 to 18.7 ) vs 4.8 ( 95 % CI , -0.2 to 9.8 ) with GM-CSF compared with placebo ( mean difference in change , 7.9 [ 95 % CI , 0.2 to 15.7 ] , P = .047 ) .
RESULTS	There were no significant differences in the ABI , WIQ distance and speed scores , claudication onset time , or mental or physical component scores of the SF-36 between the groups .
CONCLUSIONS	Therapy with GM-CSF 3 times a week did not improve treadmill walking performance at the 3-month follow-up .
CONCLUSIONS	The improvements in some secondary outcomes with GM-CSF suggest that it may warrant further study in patients with claudication .
BACKGROUND	clinicaltrials.gov Identifier : NCT01041417 .

###26037941
BACKGROUND	Previously , a study of ours showed that the combination of dabrafenib and trametinib improves progression-free survival compared with dabrafenib and placebo in patients with BRAF Val600Lys/Glu mutation-positive metastatic melanoma .
BACKGROUND	The study was continued to assess the secondary endpoint of overall survival , which we report in this Article .
METHODS	We did this double-blind phase 3 study at 113 sites in 14 countries .
METHODS	We enrolled previously untreated patients with BRAF Val600Glu or Val600Lys mutation-positive unresectable stage IIIC or stage IV melanoma .
METHODS	Participants were computer-randomised ( 1:1 ) to receive a combination of dabrafenib ( 150 mg orally twice daily ) and trametinib ( 2 mg orally once daily ) , or dabrafenib and placebo .
METHODS	The primary endpoint was progression-free survival and overall survival was a secondary endpoint .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01584648 .
RESULTS	Between May 4 , 2012 , and Nov 30 , 2012 , we screened 947 patients for eligibility , of whom 423 were randomly assigned to receive dabrafenib and trametinib ( n = 211 ) or dabrafenib only ( n = 212 ) .
RESULTS	The final data cutoff was Jan 12 , 2015 , at which time 222 patients had died .
RESULTS	Median overall survival was 251 months ( 95 % CI 192-not reached ) in the dabrafenib and trametinib group versus 187 months ( 152-237 ) in the dabrafenib only group ( hazard ratio [ HR ] 071 , 95 % CI 055-092 ; p = 00107 ) .
RESULTS	Overall survival was 74 % at 1 year and 51 % at 2 years in the dabrafenib and trametinib group versus 68 % and 42 % , respectively , in the dabrafenib only group .
RESULTS	Based on 301 events , median progression-free survival was 110 months ( 95 % CI 80-139 ) in the dabrafenib and trametinib group and 88 months ( 59-93 ) in the dabrafenib only group ( HR 067 , 95 % CI 053-084 ; p = 00004 ; unadjusted for multiple testing ) .
RESULTS	Treatment-related adverse events occurred in 181 ( 87 % ) of 209 patients in the dabrafenib and trametinib group and 189 ( 90 % ) of 211 patients in the dabrafenib only group ; the most common was pyrexia ( 108 patients , 52 % ) in the dabrafenib and trametinib group , and hyperkeratosis ( 70 patients , 33 % ) in the dabrafenib only group .
RESULTS	Grade 3 or 4 adverse events occurred in 67 ( 32 % ) patients in the dabrafenib and trametinib group and 66 ( 31 % ) patients in the dabrafenib only group .
CONCLUSIONS	The improvement in overall survival establishes the combination of dabrafenib and trametinib as the standard targeted treatment for BRAF Val600 mutation-positive melanoma .
CONCLUSIONS	Studies assessing dabrafenib and trametinib in combination with immunotherapies are ongoing .
BACKGROUND	GlaxoSmithKline .

###25271149
OBJECTIVE	Mild adverse events ( AEs ) are common with acupuncture , but the risk factors remain unclear .
OBJECTIVE	A prospective study using a standardised AE assessment and acupuncture protocol was undertaken to address the question .
METHODS	A 20-item AE report form investigated local and systemic AEs in 150 adults with insomnia randomised to receive traditional , minimal and non-invasive sham acupuncture .
METHODS	Sociodemographic , clinical and psychological variables at baseline and past history and perceived credibility of acupuncture were assessed .
RESULTS	The incidence of any AEs per patient was 42.4 % with traditional acupuncture , 40.7 % with minimal acupuncture and 16.7 % with non-invasive sham acupuncture .
RESULTS	Traditional and minimal acupuncture were associated with a greater number of local AEs , while the presence of a chronic medical condition was predictive of fewer local and systemic AEs .
RESULTS	Greater severity of insomnia , anxiety , depression , somatic symptoms and pain catastrophising thoughts were associated with lower risk , but most of the significant correlations disappeared after logistic regression .
RESULTS	Divorce and widowhood were the only significant sociodemographic variables , while previous acupuncture treatment and perceived credibility of acupuncture were found to be unrelated .
RESULTS	The risk of any AEs was higher in participants receiving traditional acupuncture ( OR 4.26 ) and minimal acupuncture ( OR 4.27 ) and in those without medical comorbidity ( OR 3.39 ) .
CONCLUSIONS	The prevalence of AEs was higher than usual , probably due to the low threshold in our definition of AEs and the systematic collection from the patients ' perspective .
CONCLUSIONS	Baseline variables were largely unable to predict AEs associated with acupuncture .
CONCLUSIONS	Further studies should explore the roles of practitioners , patients ' anxiety during treatment and patient-practitioner interactions .
BACKGROUND	NCT01707706 .

###25062874
OBJECTIVE	Pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography ( ERCP ) .
OBJECTIVE	The aim of this prospective trial was to compare the effect of ulinastatin and nafamostat on the prophylaxis of post-ERCP complications .
METHODS	A total of 159 patients who underwent ERCP were divided into ulinastatin ( n = 53 ) , nafamostat ( n = 53 ) and control ( n = 53 ) groups .
METHODS	Each patient received ulinastatin ( 150,000 units ) , nafamostat ( 20 mg ) , or placebo from 2-4 h before ERCP to 6-8 h after ERCP .
METHODS	The primary endpoint was the incidence of PEP , and the secondary endpoints were the incidence of post-ERCP hyperamylasemia , hyperlipasemia and abdominal pain .
RESULTS	The overall incidence of PEP was 6.3 % ( 10/159 ) and no significant differences were observed between ulinastatin and nafamostat groups in terms of the incidences of PEP ( 1.9 % and 3.8 % , P = 0.560 ) , hyperamylasemia , hyperlipasemia , and abdominal pain , although these were significantly lower than those of the control group ( P < 0.001 ) .
CONCLUSIONS	There was no significant difference for preventing PEP between ulinastatin and nafamostat and both drugs were efficacious for preventing post-ERCP complications .

###24929058
BACKGROUND	Dysphagia is the most common complication of anterior cervical discectomy and fusion ( ACDF ) , and it is closely related to prevertebral soft-tissue swelling ( PSTS ) .
BACKGROUND	A few studies have found that local or systemic methylprednisolone is effective against laryngopharyngeal edema and airway obstruction .
OBJECTIVE	To assess the effectiveness of short-term use of systemic methylprednisolone in relieving dysphagia and decreasing PSTS during the hospitalization period .
METHODS	A prospective study .
METHODS	Forty patients who underwent multilevel ( more than three levels ) ACDF with same plate fixation .
METHODS	Radiologic and clinical measures .
METHODS	Twenty of these patients were given 250 mg of methylprednisolone intravenously ( IV ) four times a day only for 24 hours after the operation ( at 6-hour intervals ) , whereas the remaining 20 did not receive methylprednisolone and served as controls .
METHODS	We used the Bazaz scale to compare the degree of dysphagia between groups during the hospitalization period .
METHODS	We used the C-spine lateral view to assess the degree of pre - and postoperative PSTS from C2 to C7 .
METHODS	At the final follow-up , we assessed the relationship between the occurrence of complications and steroid use .
RESULTS	The degree of dysphagia according to the Bazaz scale was less severe in the group that received methylprednisolone ( p values ; postoperative Day [ POD ] 25 < .05 , POD 6 = .014 , POD 7 = .019 ) .
RESULTS	Prevertebral soft-tissue swelling was also significantly lower in the group that received methylprednisolone ( p values ; POD 2POD 5 < .005 , POD 1 = .061 , POD 6 = .007 , POD 7 = .091 ) .
RESULTS	The amount of PSTS and dysphagia did not differ according to sex , age , smoking history , or length of surgery .
RESULTS	The period of hospitalization in the experimental group was shorter than in the control group .
RESULTS	No complications related to steroid use were found at the final follow-up .
CONCLUSIONS	The short-term use of systemic methylprednisolone after ACDF appears to be effective in relieving dysphagia and decreasing the PSTS .
CONCLUSIONS	Furthermore , the short-term use of methylprednisolone was not associated with any adverse effects of short-term IV steroid usage , such as peptic ulcer disease or postoperative infection .
CONCLUSIONS	The clinical use of methylprednisolone in relieving dysphagia and decreasing PSTS deserves consideration during the early postoperative period .

###25407464
BACKGROUND	Mass drug administration ( MDA ) with azithromycin , carried out for the control of blinding trachoma , has been linked to reduced mortality in children .
BACKGROUND	While the mechanism behind this reduction is unclear , it may be due , in part , to improved nutritional status via a potential reduction in the community burden of infectious disease .
BACKGROUND	To determine whether MDA with azithromycin improves anthropometric indices at the community level , we measured the heights and weights of children aged 1 to 4 years in communities where one ( single MDA arm ) or three annual rounds ( annual MDA arm ) of azithromycin had been distributed .
METHODS	Data collection took place three years after treatment in the single MDA arm and one year after the final round of treatment in the annual MDA arm .
METHODS	Mean height-for-age , weight-for-age and weight-for-height z scores were compared between treatment arms .
RESULTS	No significant differences in mean height-for-age , weight-for-age or weight-for-height z scores were found between the annual MDA and single MDA arms , nor was there a significant reduction in prevalence of stunting , wasting or underweight between arms .
CONCLUSIONS	Our data do not provide evidence that community MDA with azithromycin improved anthropometric outcomes of children in The Gambia .
CONCLUSIONS	This may suggest reductions in mortality associated with azithromycin MDA are due to a mechanism other than improved nutritional status .

###24980426
BACKGROUND	This study was designed to determine whether a 4 day perioperative regimen of gabapentin added to celecoxib improves in-hospital rehabilitation and physical function on postoperative day 4 and 6 weeks and 3 months after total knee arthroplasty ( TKA ) .
METHODS	After Research Ethics Board approval and informed consent , 212 patients were enrolled in a randomized , double-blinded , placebo-controlled study .
METHODS	Two hours before surgery , patients received celecoxib 400 mg p.o. and were randomly assigned to receive either gabapentin 600 mg or placebo p.o. Two hours later , patients received femoral , sciatic nerve blocks , and spinal anaesthesia .
METHODS	After operation , patients received gabapentin 200 mg or placebo three times per day ( TID ) for 4 days .
METHODS	All patients also received celecoxib 200 mg q12 h for 72 h and i.v. patient-controlled analgesia for 24 h. Pain and function were assessed at baseline , during hospitalization , on postoperative day 4 ( POD4 ) , and 6 weeks and 3 months after surgery .
RESULTS	The gabapentin group used less morphine in the first 24 h after surgery [ G = 38.3 ( 29.5 mg ) , P = 48.2 ( 29.4 mg ) ] ( P < 0.0125 ) and had increased knee range of motion compared with the placebo group in-hospital ( P < 0.05 ) .
RESULTS	There were no differences between groups in favour of the gabapentin group for pain or physical function on POD 4 [ 95 % confidence interval ( CI ) : pain : -1.4 , 0.5 ; function : -6.3 , 2.0 ] , 6 weeks ( 95 % CI : pain : 0.1 , 1.9 ; function : -0.2 , 6.5 ) or 3 months ( 95 % CI : pain : -0.2 , 1.7 ; function : -2.2 , 4.3 ) after TKA .
CONCLUSIONS	In the context of celecoxib , spinal anaesthesia , femoral and sciatic nerve blocks , a dose of gabapentin 600 mg before operation followed by 4 days of gabapentin 200 mg TID decreased postoperative analgesic requirements and improved knee range of motion after TKA .
CONCLUSIONS	Gabapentin provided no improvement in pain or physical function on POD4 and 6 weeks or 3 months after surgery .

###24246900
BACKGROUND	Under-reporting of substance use and other sensitive information is a substantial threat to internal study validity , particularly during the perinatal period .
BACKGROUND	Anonymous approaches are associated with greater disclosure but are incompatible with longitudinal follow-up .
BACKGROUND	Alternative approaches include use of a U.S. Federal Certificate of Confidentiality ( CoC ) and quasi-anonymous methods , in which there is no link between name and data .
BACKGROUND	However , the relative effect of these procedures on disclosure is unknown .
BACKGROUND	This randomized study was designed to evaluate the effects of consent condition ( anonymous , quasi-anonymous , CoC , and traditional confidentiality ) on disclosure of sensitive information among postpartum women .
METHODS	Participants were 200 postpartum , primarily African-American women who were randomly assigned to one of the four consent conditions and completed a brief computer-delivered assessment of alcohol and drug use , sexual risk , intimate partner violence , and emotional distress .
RESULTS	Participants in the anonymous and quasi-anonymous conditions disclosed significantly more sensitive information than those in the traditional consent condition .
RESULTS	In contrast , no advantage in overall disclosure was observed for the CoC condition .
RESULTS	This result was largely consistent across specific content areas with the exception of emotional distress , disclosure of which was unrelated to consent condition .
CONCLUSIONS	Although use of a CoC has limited impact on disclosure , the quasi-anonymous method may increase disclosure to a similar extent as full anonymity .
CONCLUSIONS	Quasi-anonymous approaches should be considered when under-reporting is likely , a context in which the disadvantages of this approach must be balanced against its advantages .

###24279747
BACKGROUND	Protein-energy wasting ( PEW ) is common in hemodialysis patients and is a powerful predictor of morbidity and mortality .
BACKGROUND	Although much progress has been made in recent years in identifying the causes and pathogenesis of PEW in hemodialysis patients , actual management by nutritional interventions is not always able to correct PEW .
BACKGROUND	Some investigators suggest that physical exercise may increase the anabolic effects of nutritional interventions , and therefore may have a potential to reverse PEW .
BACKGROUND	The aim of this study is to investigate the effect of intra-dialytic progressive exercise training and adequate nutritional supplementation on markers of PEW , functional capacities and quality of life of adult hemodialysis patients .
METHODS	Fifty end-stage renal disease patients undergoing hemodialysis , who meet the diagnostic criteria for PEW , will be randomly allocated into an exercise or control group for 6 months .
METHODS	The exercise consists of a progressive submaximal individualized cycling exertion using an adapted cycle ergometer , during the three weekly dialysis sessions .
METHODS	Biological markers of nutrition ( albumin , prealbumin ) will be followed monthly and all patients will be assessed for body composition , walk function , muscle strength , postural stability and quality of life at baseline and during the eighth week ( t +2 ) , the sixteenth week ( t +4 ) and the twenty-fourth week ( t +6 ) of the 6-month adapted rehabilitation program .
CONCLUSIONS	The successful completion of this current trial may give precious clues in understanding PEW and encourage nephrologists to extend prescription of exercise programs as well as therapeutic and as preventive interventions in this high-risk population .
BACKGROUND	The protocol for this study was registered with the France Clinical Trials Registry NCT01813851 .

###25263087
OBJECTIVE	The knowledge of factors that may influence blood donation in Cameroon is limited .
OBJECTIVE	The objectives of this study are to assess the characteristics of previous and potential blood donors by exploring the religious beliefs , and knowledge and understanding of blood donations among individuals present at a district hospital .
METHODS	Forty-nine in-depth , semi-structured interviews were conducted among consenting , randomly selected 18 years or older community members present at a district hospital in the Adamaoua region during October and November 2011 .
RESULTS	Ninety-eight per cent ( 48/49 ) of the individuals present at this district hospital had heard of blood transfusions .
RESULTS	Forty-seven per cent ( 23/49 ) had not previously been asked to donate blood ; however , 94 % ( 44/47 ) said that they would donate if given the opportunity .
RESULTS	Thirty-three per cent ( 16/49 ) had previously donated blood to family members or for replacement , and 81 % of these said they would repeat donations .
RESULTS	The majority of both donors and non-donors were motivated to donate blood for altruistic reasons .
CONCLUSIONS	The findings suggest that community members present at this district hospital in Cameroon may be recruited for repeat blood donations .
CONCLUSIONS	Although the altruistic motivation to donate blood suggests that donors could be recruited from a district hospital population , targeted information about blood donations and accessible blood transfusion services need to be put in place .
CONCLUSIONS	The study may add to the understanding of the preconditions for blood donations and the possibility to establish sustainable blood transfusion services in the Adamaoua region in Cameroon .

###25623589
BACKGROUND	Antibiotic-resistant strains of pathogenic bacteria are increasingly prevalent in hospitals and the community .
BACKGROUND	Acute exacerbations of COPD ( AE-COPD ) often result in administration of antibiotics although more than half of exacerbations are associated with detection of respiratory viruses and potentially pathogenic bacteria can only be detected in 20-30 % of cases .
BACKGROUND	There is a paucity of placebo-controlled clinical trials and up to today no single study has been powered sufficiently to prove the efficacy of antibiotic treatment in AE-COPD .
BACKGROUND	Most studies so far did not include current standards of care comprising administration of systemic corticosteroids .
METHODS	A total of 980 patients with moderate acute exacerbations will be included in 22 German centers ( hospitals and private practices ) .
METHODS	Patients will receive a standardized treatment for exacerbation including systemic corticosteroids , inhaled bronchodilators and supplementary oxygen if needed and will be randomized to additional treatment with placebo or antibiotic ( oral sultamicillin ) for five days.The primary endpoint is clinical failure defined by need for additional antibiotic treatment until day 30 .
METHODS	Secondary endpoints will assure that management of AE-COPD without antibiotics does not result either in increased occurrence of relapse , new exacerbations , prolonged recovery , or unwanted long-term consequences .
CONCLUSIONS	ABACOPD will be the first sufficiently powered double-blind placebo-controlled study in the field to systematically assess the question whether antibiotics , known to increase antibiotic resistance , are really needed in a well-defined patient cohort receiving state-of-the art treatment in all other aspects .
BACKGROUND	ClinicalTrials.gov : NCT01892488 .

###25061707
OBJECTIVE	To determine the effects of resveratrol ( RES ) on growth and immune status in chickens receiving conventional vaccinations .
METHODS	Two hundred forty 1-day-old layer chickens .
METHODS	Chickens received conventional vaccinations throughout the study and were randomly assigned to 1 of 4 treatments in 6 replicate pens/treatment .
METHODS	Treatments included 1 control group ( basal diet ) and 3 experimental groups fed the basal diet plus 200 , 400 , and 800 mg of RES/kg of diet .
METHODS	At 40 days of age , 1 bird/pen was randomly selected to have blood and tissues collected to determine serum immunity indices ; mRNA relative expression of proinflammatory cytokines in splenocytes ; mRNA relative expression of nuclear transcription factor-B , growth hormone receptor , and insulin-like growth factor-1 in hepatocytes ; cell proliferation ; and apoptosis .
RESULTS	Average daily gain , antibody titers against Newcastle disease virus and avian influenza viruses H5 and H9 , and insulin-like growth factor-1 expression were quadratically increased with increasing RES concentration .
RESULTS	In hepatocytes , growth hormone receptor gene mRNA relative expression was quadratically increased and nuclear transcription factor-B gene mRNA relative expression was linearly decreased with increasing RES concentration .
RESULTS	In splenocytes , nterleukin-1 and tumor necrosis factor - mRNA relative expression was linearly decreased with increasing RES concentration .
RESULTS	Resveratrol supplementation delayed cell proliferation and reduced apoptosis in immunocytes .
RESULTS	With increasing RES concentration , proliferation index and relative weight of the thymus , ratio of CD4 + to CD8 + cells , and CD4 + cell count were quadratically increased , and IgM concentration was linearly increased .
CONCLUSIONS	Dietary resveratrol supplementation improved growth , protected immunocytes against antigen-induced apoptosis , and upregulated immune response in chickens that received conventional vaccinations .

###24890456
BACKGROUND	Various external factors can influence patients ' experiences of noxious stimuli , but little is known of how patients ' natural behaviour may be relevant .
BACKGROUND	We ascertained how often patients spontaneously look or look away during venepuncture and associated reports of pain during a previously reported experimental randomized study .
BACKGROUND	The study was conducted in the outpatient department of a U.K. district general hospital .
METHODS	Patients were randomized to hearing ` sharp scratch ' or the verbal cue ` ready ? '
METHODS	immediately before venepuncture .
METHODS	Whether patients looked or looked away during needle insertion was recorded .
METHODS	Patients were asked to rate their pain using a verbal numerical rating score ( VNRS ) and verbal response scale ( VRS ) .
RESULTS	One hundred ninety-two patients were included ; mean age 51.7 years , 55 % male .
RESULTS	During needle insertion , 73 % spontaneously looked away , whereas 27 % looked .
RESULTS	There was no significant difference in the proportion of these patients assigned to the ` sharp scratch ' or ` ready ? '
RESULTS	groups , nor was there any difference in mean age or gender .
RESULTS	For the group that looked , mean VNRS was 0.48 and VRS was 1.27 , significantly less than the group that looked away ( mean VNRS 0.94 , p = 0.014 ; VRS 1.61 , p = 0.002 ) .
RESULTS	As previously reported , pain ratings between ` sharp scratch ' and ` ready ? '
RESULTS	groups were not significantly different .
CONCLUSIONS	Almost three quarters of patients spontaneously look away during venepuncture , but their pain ratings are almost twice that of the quarter of patients who look .
CONCLUSIONS	It is unclear why this may be , but previous experimental studies indicate that observing the body when a noxious stimulus is applied can have an analgesic effect .

###24273453
OBJECTIVE	The aim of this study was to investigate if there is any interaction between ondansetron and nefopam when they are continuously co-administrated during patient-controlled intravenous analgesia ( PCIA ) .
METHODS	The study was a prospective , randomized , controlled , non-inferiority clinical trial comparing nefopam-plus-ondansetron to nefopam alone .
METHODS	A total of 230 postoperative patients using nefopam for PCIA , were randomly assigned either to a group receiving continuous infusion of ondansetron ( Group O ) or to the other group receiving the same volume of normal saline continuously ( Group N ) .
METHODS	Postoperative pain intensity scores , the sum of pain intensity difference over 24 hours postoperatively ( SPID24hr ) , the incidence of adverse events , and the total consumption of nefopam were evaluated respectively .
RESULTS	Postoperative pain was treated successfully in both groups .
RESULTS	The mean SPID24hr scores were 95.6 mm in Group N and 109.3 mm in Group O [ 95 % confidence interval ( CI ) -14.28 , 24.32 ] .
RESULTS	The lower margin of the 95 % CI was above the pre-determined non-inferiority margin ( -30 mm ) for SPID24hr , which indicated that nefopam-plus-ondansetron was not worse than the nefopam alone in term of analgesic efficacy .
RESULTS	In addition , there was no statistical difference between the two groups in term of cumulative consumption of nefopam .
RESULTS	Compared with Group N , postoperative vomiting was significantly reduced in Group O during the postoperative 24 hours ( P < 0.05 ) .
RESULTS	Less rescue antiemetics were given to patients in Group O than those receiving nefopam alone ( P < 0.05 ) .
RESULTS	There were no differences in postoperative nausea between the two groups .
CONCLUSIONS	Nefopam-plus-ondansetron is not inferior to nefopam alone in relieving the pain in PCIA after minimally invasive surgery .
CONCLUSIONS	In addition , adverse events are reduced without compromising analgesic efficacy .

###24241606
OBJECTIVE	To evaluate the efficacy of a delayed home exercise programme compared with normal care after primary total knee arthroplasty .
METHODS	Single-blind , prospective , randomized , controlled trial .
METHODS	A total of 108 participants ( 61 % females , mean age 69 years [ standard deviation 8.7 ] ) , were randomized to a home-based exercise group ( EG , n = 53 ) or to a control group ( CG , n = 55 ) .
METHODS	Two months post-operatively , the EG received a home exercise programme , while the CG received no additional guidance .
METHODS	The outcome measurements were : pain and disability , measured using the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) ; health-related quality of life ( HRQoL ) , measured using the Short Form-36 questionnaire ( SF-36 ) ; maximal walking speed ; isometric knee muscle strength ; and the Timed Up and Go ( TUG ) test .
METHODS	Measurements were made at baseline and at 12 months thereafter .
RESULTS	At the 12-month follow-up , maximal walking speed ( p < 0.001 ) and knee flexion strength ( p = 0.009 ) were significantly greater in the EG .
RESULTS	Both groups showed similar improvements in all of the WOMAC subscale scores , the SF-36 summary scores and the TUG time .
CONCLUSIONS	Home-based training was not superior to normal care with regard to pain , disability or HRQoL , but resulted in greater improvement in objectively measured physical performance .

###24710342
BACKGROUND	Corticosteroids have been evaluated for management of severe Mycoplasma pneumoniae pneumonia ( MP ) in children .
BACKGROUND	However , it is unclear whether the timing of treatment with corticosteroids affects the patients ' clinical outcome .
METHODS	We did a prospective randomized clinical trial to evaluate the effect of early use of corticosteroids .
METHODS	Fifty-three patients were randomly assigned to treatment with corticosteroids within 24 h after admission ( cases ) , and 53 patients were treated 72 h after admission ( control patients ) .
RESULTS	Cases had a shorter fever duration [ 6 days ( range 5-11 ) vs. 10 days ( range 8-23 ) , p < 0.001 ] and length of hospital stay [ 8 days ( range 5-15 ) vs. 10 days ( range 5-21 ) , p = 0.001 ] .
RESULTS	Four cases ( 1.9 % ) had a complete radiographic resolution time > 4 weeks compared with 10 control patients ( 17.5 % ; p = 0.038 ; Table 2 ) .
CONCLUSIONS	Early treatment with corticosteroids was associated with a better outcome in patients with severe MP .

###25979300
OBJECTIVE	Endotracheal intubation ( ETI ) is an essential resuscitation procedure in children .
OBJECTIVE	Video laryngoscopes have been developed to avoid intubation failures in a variety of scenarios , including cardiopulmonary resuscitation .
OBJECTIVE	We hypothesized that the video laryngoscope RIFL ( AI Medical Devices , Inc , Williamston , MI ) offers advantages in the ETI of a pediatric manikin while performing chest compressions ( CCs ) .
METHODS	Randomized nonblinded crossover simulation trial conducted among 132 paramedics with no prior experience with RIFL .
METHODS	Each participant performed intubations with Miller ( MIL ; Mercury Medical , Clearwater , FL ) laryngoscope and RIFL in a PediaSIM CPR training manikin ( FCAE HealthCare , Sarasota , FL ) in 3 airway scenarios : ( a ) normal airway at rest ( without concomitant CC ) , ( b ) normal airway with mechanically controlled CC , and ( c ) difficult airway with concomitant CC .
METHODS	The primary outcome was the time to intubation , and secondary one was the success of the intubation attempt .
RESULTS	In the manikin at rest with normal airway , nearly all participants performed successful ETI both with MIL and RIFL , with similar intubation times .
RESULTS	However , in the other scenarios ( normal and difficult airway with uninterrupted CC ) , the results with RIFL were significantly better than with MIL ( P < .05 ) for all the analyzed variables ( success of first attempt , overall success rate , time to intubation , Cormac-Lehane grade , dental compression , and easy of intubation scores ) .
CONCLUSIONS	In simulated child arrest scenarios with normal/difficult airway conditions and with concomitant mechanical CC , paramedics performed better with the RIFL video laryngoscope than with the standard MIL .

###24571703
OBJECTIVE	To determine if a stabilised , stannous-containing sodium fluoride dentifrice provides greater enamel protection in situ against intraoral dietary erosive challenges compared with a sodium fluoride/potassium nitrate dentifrice .
METHODS	A single-centre , investigator blind , randomised , supervised , two-treatment , non-brushing , four-period crossover in situ study was undertaken , with each test period being 15 days .
METHODS	Thirty-five healthy adult subjects were recruited to participate in the study , which included four erosive acid challenges per day .
METHODS	Subjects were randomised to product treatment , which included either : ( 1 ) a stannous-containing sodium fluoride dentifrice ( Oral-B ( ) Pro-Expert Sensitive ) or ( 2 ) a sodium fluoride/potassium nitrate dentifrice ( Sensodyne ( ) Pronamel ( ) ) .
METHODS	Each study subject wore an intraoral appliance retaining two sterilised , polished human enamel samples for 6 hours/day .
METHODS	Subjects swished with an allocated dentifrice slurry twice a day and with 250 ml of orange juice for 10 minutes ( 25 ml/minute over a 10-minute period ) four times per day .
METHODS	The primary and secondary outcomes for this study were enamel loss measured using contact profilometry at days 15 and 5 , respectively , using parametric analysis methods .
RESULTS	At day 15 , a 38 % lower enamel loss ( P < 0.0001 ) was observed , with estimated medians of 2.03 m ( SE 0.247 ) and 3.30 m ( SE 0.379 ) , in favour of the stannous-containing dentifrice .
RESULTS	At day 5 , specimens treated with the stannous-containing sodium fluoride dentifrice demonstrated 25 % less enamel loss than those treated with the sodium fluoride/potassium nitrate dentifrice .
RESULTS	Treatment differences at day 5 were also statistically significant ( P < 0.05 ) , with estimated medians of 1.37 m ( SE 0.177 ) and 1.83 m ( SE 0.223 ) , respectively .
CONCLUSIONS	Results of this in situ study suggest the stabilised , stannous-containing sodium fluoride dentifrice could be used to provide significantly greater protection to enamel from erosive acid challenge compared with that provided by conventional fluoride-containing products .

###25028951
OBJECTIVE	To compare the effectiveness of the alveolar recruitment maneuver and the breath stacking technique with respect to lung mechanics and gas exchange in patients with acute lung injury .
METHODS	Thirty patients were distributed into two groups : Group 1 - breath stacking ; and Group 2 - alveolar recruitment maneuver .
METHODS	After undergoing conventional physical therapy , all patients received both treatments with an interval of 1 day between them .
METHODS	In the first group , the breath stacking technique was used initially , and subsequently , the alveolar recruitment maneuver was applied .
METHODS	Group 2 patients were initially subjected to alveolar recruitment , followed by the breath stacking technique .
METHODS	Measurements of lung compliance and airway resistance were evaluated before and after the use of both techniques .
METHODS	Gas analyses were collected before and after the techniques were used to evaluate oxygenation and gas exchange .
RESULTS	Both groups had a significant increase in static compliance after breath stacking ( p = 0.021 ) and alveolar recruitment ( p = 0.03 ) , but with no significant differences between the groups ( p = 0.95 ) .
RESULTS	The dynamic compliance did not increase for the breath stacking ( p = 0.22 ) and alveolar recruitment ( p = 0.074 ) groups , with no significant difference between the groups ( p = 0.11 ) .
RESULTS	The airway resistance did not decrease for either groups , i.e. , breath stacking ( p = 0.91 ) and alveolar recruitment ( p = 0.82 ) , with no significant difference between the groups ( p = 0.39 ) .
RESULTS	The partial pressure of oxygen increased significantly after breath stacking ( p = 0.013 ) and alveolar recruitment ( p = 0.04 ) , but there was no significant difference between the groups ( p = 0.073 ) .
RESULTS	The alveolar-arterial O2 difference decreased for both groups after the breath stacking ( p = 0.025 ) and alveolar recruitment ( p = 0.03 ) interventions , and there was no significant difference between the groups ( p = 0.81 ) .
CONCLUSIONS	Our data suggest that the breath stacking and alveolar recruitment techniques are effective in improving the lung mechanics and gas exchange in patients with acute lung injury .

###25880004
BACKGROUND	This randomised , open-label , multicenter phase II study compared progression-free survival ( PFS ) of S-1 plus oxaliplatin ( SOX ) with that of S-1 alone in patients with gemcitabine-refractory pancreatic cancer .
METHODS	Patients with confirmed progressive disease following the first-line treatment with a gemcitabine-based regimen were randomised to receive either S-1 ( 80/100/120mgday ( -1 ) based on body surface area ( BSA ) , orally , days 1-28 , every 6 weeks ) or SOX ( S-1 80/100/120mgday ( -1 ) based on BSA , orally , days 1-14 , plus oxaliplatin 100mgm ( -2 ) , intravenously , day 1 , every 3 weeks ) .
METHODS	The primary end point was PFS .
RESULTS	Between January 2009 and July 2010 , 271 patients were randomly allocated to either S-1 ( n = 135 ) or SOX ( n = 136 ) .
RESULTS	Median PFS for S-1 and SOX were 2.8 and 3.0 months , respectively ( hazard ratio ( HR ) = 0.84 ; 95 % confidence interval ( CI ) , 0.65-1 .08 ; stratified log-rank test P = 0.18 ) .
RESULTS	Median overall survival ( OS ) was 6.9 vs 7.4 months ( HR = 1.03 ; 95 % CI , 0.79-1 .34 ; stratified log-rank test P = 0.82 ) .
RESULTS	The response rate ( RR ) was 11.5 % vs 20.9 % ( P = 0.04 ) .
RESULTS	The major grade 3/4 toxicities ( S-1 and SOX ) were neutropenia ( 11.4 % and 8.1 % ) , thrombocytopenia ( 4.5 % and 10.3 % ) and anorexia ( 12.9 % and 14.7 % ) .
CONCLUSIONS	Although SOX showed an advantage in RR , it provided no significant improvement in PFS or OS compared with S-1 alone .

###24599421
OBJECTIVE	Changes in cancer therapy , in addition to changes in obesity prevalence , suggest the need for a current assessment of weight gain patterns following breast cancer diagnosis .
OBJECTIVE	The aim of this study was to evaluate factors associated with weight gain among breast cancer survivors prior to enrolling into a behavioral weight loss intervention .
METHODS	Anthropometric measures and data on weight-related factors were collected at baseline on 665 breast cancer survivors .
METHODS	Postdiagnosis weight gain was determined between entry into the trial and previous diagnosis up to 5 years .
METHODS	Multivariate logistic regression analyses were used to evaluate the association between weight gain and influencing factors .
RESULTS	The mean weight gain was 4.5 % body weight ( standard deviation = 10.6 ) ; 44 % of women experienced 5 % body weight gain .
RESULTS	The risk of weight gain was inversely associated with age ( adjusted odds ratio ( ORadj ) = 0.97 , 95 % confidence interval ( 95 % CI ) 0.95-0 .99 ) , Hispanic ethnicity ( ORadj = 0.30 , 95 % CI 0.13-0 .68 ) , and overweight ( ORadj = 0.11 , 95 % CI 0.05-0 .23 ) or obese ( ORadj = 0.03 , 95 % CI 0.02-0 .07 ) status at diagnosis and positively associated with time elapsed since diagnosis ( ORadj = 1.19 / year , 95 % CI 1.04-1 .36 ) .
RESULTS	Women prescribed aromatase inhibitors were 46 % less likely to gain weight compared to women prescribed selective estrogen-receptor modulators ( ORadj = 0.54 , 95 % CI 0.31-0 .93 ) .
RESULTS	The risk of weight gain was positively associated with smoking at diagnosis ( ORadj = 2.69 , 95 % CI 1.12-6 .49 ) although this was attributable to women who subsequently quit smoking .
CONCLUSIONS	Postdiagnosis weight gain is common and complex and influenced by age , ethnicity , weight , smoking status , time elapsed since diagnosis , and endocrine-modulating therapy .
CONCLUSIONS	Weight gain continues to be a concern following a diagnosis of breast cancer .
CONCLUSIONS	Factors influencing this weight gain include age , ethnicity , weight , smoking status , time elapsed since diagnosis , and endocrine-modulating therapy .
CONCLUSIONS	Effective weight management strategies are needed for this population of women .

###24298765
OBJECTIVE	To observe the efficacy on post-stroke mild cognitive impairment ( MCI ) treated with acupuncture at Jing-well points on the differentiated meridians and temple-three-needle therapy .
METHODS	Seventy-three of stroke patients were randomized into an acupuncture group ( 37 cases ) and a conventional treatment group ( 36 cases ) .
METHODS	Twenty healthy aged people in physical examination were collected as a control group .
METHODS	In the acupuncture group , on the basis of the conventional treatment of internal medication , the acupuncture at Jing-well points on the differentiated meridians and temple-three-needle therapy were applied .
METHODS	In the conventional treatment group , no any therapy was used except the conventional treatment of internal medication .
METHODS	In the control group , no any intervention was adopted .
METHODS	Neuroscan Nuamps electroencephalogram recording analysis system was used to determine the event-related potentials P300 , and the amplitude and mini mental state examination ( MMSE ) score was observed before and after treatment in both groups .
RESULTS	After treatment , in the acupuncture group , P300 latent stage was shortened , and the amplitude and the score of MMSE were increased ( P < 0.05 , P < 0.01 ) .
RESULTS	In the conventional treatment group , above indices were not changed obviously as compared with that before treatment ( all P > 0.05 ) .
RESULTS	Compared with the conventional treatment group , the differences in P300 latent stage , amplitude and MMSE score were remarkable in the acupuncture group ( P < 0.05 , P < 0.01 ) .
CONCLUSIONS	The acupuncture at Jing-well points on the differentiated meridians and temple-three-needle therapy improves the cognitive function of the patients with MCI .

###25222185
BACKGROUND	Postural tachycardia syndrome ( POTS ) is characterized clinically not only by an exaggerated increase in heart rate ( HR ) , but an associated cognitive impairment that disables many patients .
BACKGROUND	Modafinil might be effective in improving the cognitive symptoms , but modafinil may stimulate the sympathetic nervous system and worsen tachycardia in POTS .
BACKGROUND	We tested the hypothesis that modafinil would worsen tachycardia and orthostatic symptoms in POTS .
METHODS	Patients with POTS ( n = 54 ) underwent a randomized crossover trial with modafinil 100 mg versus placebo .
METHODS	Heart rate and systolic blood pressure ( SBP ) were measured seated and standing before modafinil or placebo administration and then hourly for 4 hours .
RESULTS	Over 4 hours , standing HR was not significantly different between the modafinil and placebo groups ( analysis of variance [ ANOVA ] Pdrug = 0.328 ) , but seated SBP was significantly higher in the modafinil group ( mean [ SD ] , 109 [ 12 ] mm Hg vs 104 [ 10 ] mm Hg ; P = 0.004 ) .
RESULTS	Modafinil also significantly increased both the seated SBP ( ANOVA Pdrug = 0.004 ) and the standing SBP ( ANOVA Pdrug = 0.041 ) over time .
RESULTS	There was no significant difference between modafinil and placebo over the 4-hour period with regard to POTS symptom burden scores ( 14 [ 12 ] vs 14 [ 12 ] ; P = 0.962 ) .
CONCLUSIONS	Modafinil did not significantly worsen standing HR or acute orthostatic symptoms in patients with POTS compared with the placebo group and improved upright blood pressure .
CONCLUSIONS	Therefore , modafinil could be tested as a potential treatment for the cognitive impairment in POTS .

###25199441
OBJECTIVE	To evaluate changes in anterior corneal topography and higher-order aberrations ( HOA ) after 14-days of rigid gas-permeable ( RGP ) contact lens ( CL ) wear in keratoconus subjects comparing two different fitting approaches .
METHODS	Thirty-one keratoconus subjects ( 50 eyes ) without previous history of CL wear were recruited for the study .
METHODS	Subjects were randomly fitted to either an apical-touch or three-point-touch fitting approach .
METHODS	The lens ' back optic zone radius ( BOZR ) was 0.4 mm and 0.1 mm flatter than the first definite apical clearance lens , respectively .
METHODS	Differences between the baseline and post-CL wear for steepest , flattest and average corneal power ( ACP ) readings , central corneal astigmatism ( CCA ) , maximum tangential curvature ( KTag ) , anterior corneal surface asphericity , anterior corneal surface HOA and thinnest corneal thickness measured with Pentacam were compared .
RESULTS	A statistically significant flattening was found over time on the flattest and steepest simulated keratometry and ACP in apical-touch group ( all p < 0.01 ) .
RESULTS	A statistically significant reduction in KTag was found in both groups after contact lens wear ( all p < 0.05 ) .
RESULTS	Significant reduction was found over time in CCA ( p = 0.001 ) and anterior corneal asphericity in both groups ( p < 0.001 ) .
RESULTS	Thickness at the thinnest corneal point increased significantly after CL wear ( p < 0.0001 ) .
RESULTS	Coma-like and total HOA root mean square ( RMS ) error were significantly reduced following CL wearing in both fitting approaches ( all p < 0.05 ) .
CONCLUSIONS	Short-term rigid gas-permeable CL wear flattens the anterior cornea , increases the thinnest corneal thickness and reduces anterior surface HOA in keratoconus subjects .
CONCLUSIONS	Apical-touch was associated with greater corneal flattening in comparison to three-point-touch lens wear .

###26025767
BACKGROUND	The current debate on overdiagnosis and overtreatment of screen-detected ductal carcinoma in situ ( DCIS ) urges the need for prospective studies to address this issue .
BACKGROUND	A substantial number of DCIS lesions will never form a health hazard , particularly if it concerns non - to slow-growing low-grade DCIS .
BACKGROUND	The LORD study aims to evaluate the safety of active surveillance in women with low-risk DCIS .
METHODS	This is a randomised , international multicentre , open-label , phase III non-inferiority trial , led by the Dutch Breast Cancer Research Group ( BOOG 2014-04 ) and the European Organization for Research and Treatment of Cancer ( EORTC-BCG 1401 ) .
METHODS	Standard treatment will be compared to active surveillance in 1240 women aged 45 years with asymptomatic , screen-detected , pure low-grade DCIS based on vacuum-assisted biopsies of microcalcifications only .
METHODS	Both study arms will be monitored with annual digital mammography for a period of 10 years .
METHODS	The primary end-point is 10-year ipsilateral invasive breast cancer free percentage .
METHODS	Secondary end-points include patient reported outcomes , diagnostic biopsy rate during follow-up , ipsilateral mastectomy rate and translational research .
RESULTS	To explore interest in and feasibility of the LORD study we conducted a survey among EORTC and BOOG centres .
RESULTS	A vast majority of EORTC and BOOG responding centres expressed interest in participation in the LORD study .
RESULTS	The proposed study design is endorsed by nearly all centres .

###24768615
OBJECTIVE	Although falls in people with Parkinson 's disease ( PD ) associate with dual tasking and freezing of gait ( FoG ) , it is not known whether falls during dual tasking are due to FoG .
OBJECTIVE	This study investigated the effects of a cognitive task on the occurrence of falls and FoG when subjects with PD step in response to a postural perturbation .
METHODS	Ten subjects with PD and a history of FoG as well as 10 age-matched subjects without PD stepped in response to large , backward displacements of the support surface , with and without performing a fluency task of listing items in a category .
METHODS	Subjects with PD performed the task in the `` off '' and `` on '' dopaminergic medication states .
METHODS	We recorded the percentage of trials with FoG ( a lack of step in response to the perturbation ) , foot-lift latencies , and trials with falls into a safety harness .
RESULTS	Dual tasking significantly increased the incidence of falls in people with PD , but subjects without PD did not fall in any condition .
RESULTS	Dual tasking did not significantly increase trials without steps or foot-lift latencies .
RESULTS	Falls were often coincident with a lack of step ( FoG ) in the single-task condition , but the increased falls with dual tasking occurred on trials with steps .
RESULTS	Levodopa tended to decrease FoG and falls with or without dual tasking .
RESULTS	However , medication did not significantly alter the effects of dual tasking on FoG or falls .
CONCLUSIONS	For people with PD and FoG , forward falls may not always be caused by FoG , particularly under attention-distracting conditions .

###24706729
BACKGROUND	Observational studies suggest that breastfeeding benefits later maternal child-feeding practices , which in turn may contribute to positive eating attitudes .
BACKGROUND	We investigated the effect of a randomized intervention to increase duration and exclusivity of breastfeeding on pre-adolescent eating attitudes .
METHODS	Long-term follow-up of the Promotion of Breastfeeding Intervention Trial ( PROBIT ) , a cluster-randomized trial in 31 maternity hospitals and affiliated polyclinics in Belarus .
METHODS	Sites were randomly assigned an experimental intervention to promote longer duration and exclusivity of breastfeeding in mothers who initiated breastfeeding ( n = 16 sites ) , or a control intervention of continuing usual care ( n = 15 sites ) ; 17 046 healthy infants were enrolled in 1996-7 , of whom 13 751 ( 80.7 % ) completed the Children 's Eating Attitude Test ( ChEAT ) at 11.5 years of age .
METHODS	A ChEAT score 22.5 ( 85th percentile ) was used as an indicator of problematic eating attitudes .
METHODS	Analysis was based on intention-to-treat , accounting for clustering within hospitals/clinics .
RESULTS	Compared with the control arm , the experimental intervention substantially increased breastfeeding exclusivity ( 43.3 % vs 6.4 % exclusively breastfed at 3 months of age ) and duration of any breastfeeding throughout infancy .
RESULTS	The proportion of children with ChEAT scores 22.5 was lower in the experimental than control arm ( boys 11.4 % vs 17.2 % ; girls 18.5 % vs 23.4 % ) [ cluster-adjusted odds ratio ( OR ) , boys : 0.44 ; 95 % confidence interval ( CI ) : 0.21,0.93 ; girls : 0.51 ; 95 % CI : 0.27,0.99 ) .
RESULTS	Results were robust to adjustment for potential confounders and using a ChEAT score 25.5 ( 91st percentile ) as the outcome ( OR : 0.53 ; 95 % CI : 0.28,1.03 ) .
CONCLUSIONS	An intervention to improve the duration and exclusivity of breastfeeding among term infants in Belarus was associated with a reduction in problematic eating attitudes at 11.5 years of age .

###24492159
OBJECTIVE	This qualitative study examines performance bias , i.e. unintended differences between groups , in the context of a weight loss trial in which a novel patient counseling program was compared to usual care in general practice .
METHODS	14/381 consecutive interviewees ( 6 intervention group , 8 control group ) within the CAMWEL ( Camden Weight Loss ) effectiveness trial process study were asked about their engagement with various features of the research study and a thematic content analysis undertaken .
RESULTS	Decisions to participate were interwoven with decisions to change behavior , to the extent that for many participants the two were synonymous .
RESULTS	The intervention group were satisfied with their allocation .
RESULTS	The control group spoke of their disappointment at having been offered usual care when they had taken part in the trial to access new forms of help .
RESULTS	Reactions to disappointment involved both movements toward and away from behavior change .
CONCLUSIONS	There is a prima facie case that reactions to disappointment may introduce bias , as they lead the randomized groups to differ in ways other than the intended experimental contrast .
CONCLUSIONS	In-depth qualitative studies nested within trials are needed to understand better the processes through which bias may be introduced .

###24353023
OBJECTIVE	To evaluate serum pharmacokinetics of tapentadol administered to healthy subjects as extended-release ( ER ) tablets .
METHODS	Seven single-dose studies ( five randomized , crossover , bioequivalence studies ; a study in Japanese men ; and a randomized , crossover , effects-of-food study ) and one repeated-dose study .
METHODS	Clinical research settings in the United States and The Netherlands .
METHODS	Healthy males and females were enrolled into seven studies ; one study enrolled only Japanese males .
METHODS	In the bioequivalence studies , subjects first received one polyethylene oxide - or hypromellose-based tapentadol ER tablet ( 50 , 100 , 150 , 200 , or 250 mg ; one dose per study ) , then ( after washout ) the other formulation ( matching dose ) .
METHODS	In all other studies , subjects received polyethylene oxide-based tapentadol ER tablets .
METHODS	In the repeated-dose study , subjects received one 250 mg tablet , then ( after washout ) one 250 mg tablet every 12 hours ( five doses ) .
METHODS	In the food-effect study , subjects received one 250 mg tablet within 30 minutes after a high-fat meal or after 10 hours of fasting .
METHODS	In the study in Japanese men , subjects received one 100 mg tablet .
METHODS	Maximum tapentadol concentrations ( Cmax ) were typically observed 5 hours after dosing .
METHODS	Mean terminal half-life values ranged from 4.4 to 5.9 hours .
METHODS	Tapentadol Cmax and AUC values increased proportionally following single ER ( polyethylene oxide-based tablets ) doses of 50 to 250 mg .
METHODS	Trough tapentadol concentrations increased during repeat dosing until reaching steady-state by the third dose .
METHODS	Serum Cmax and area under the concentration-time curve ( AUC ) values at steady state were 1.6 and 1.9 times higher relative to single-dose administration .
METHODS	Coadministration of the 250 mg dose with a high-fat meal increased Cmax and AUC values by an average of < 17 percent .
CONCLUSIONS	The pharmacokinetics of tapentadol ER are consistent after repeated and single-dose administration .
CONCLUSIONS	Tapentadol ER may be administered without regard to food intake .
CONCLUSIONS	No clinically significant differences were observed in the pharmacokinetics of tapentadol between Japanese and Caucasian subjects .

###25958710
BACKGROUND	Children often require relief of pain and anxiety when undergoing painful procedures .
OBJECTIVE	To determine the differences by comparing fentanyl and ketamine used in cancer-diagnosed children undergoing painful procedures .
METHODS	A randomized , double-blinded , crossover trial was conducted with 55 children undergoing painful procedures ( intrathecal chemotherapy and/or bone marrow aspiration/biopsy ) .
METHODS	Patients were randomly assigned in a double-blinded fashion to receive either intravenous fentanyl or ketamine at 1 mcg/kg/dose and 1 mg/kg/dose , respectively .
METHODS	The result in effectiveness of the drug was measured using three parameters , 1 ) satisfaction score ranging from 0 to 10 , 2 ) perception of procedural pain using FLACC scale , Wong-Baker FACES Pain Rating Scale and Visual Analog Scale , and 3 ) the frequency of vomiting nausea score .
RESULTS	The satisfaction amongpatients receiving fentanyl was significantly greater than ketamine ( p = 0.007 ) .
RESULTS	In addition , both painful and nausea/vomiting were significantly decreased in the patients receiving fentanyl ( p = 0.002 and p < 0.001 , respectively ) .
RESULTS	No serious complications were observed
CONCLUSIONS	This study demonstrated that intravenous fentanyl generated a superior clinical effect in satisfaction , decreased pain and nausea/vomiting , and showed no significant side-effects over ketamine .
CONCLUSIONS	Fentanyl may also be recommended as a reasonable option before undergoing oncology procedures in children with cancer .

###24721158
BACKGROUND	Coronary heart disease ( CHD ) places a major burden on the Australian health care system .
BACKGROUND	Determining the likelihood of CHD in a patient presenting with chest pain can be particularly difficult in a remote setting where access to transportation and specialised investigations including myocardial stress studies and coronary angiography can be difficult and delayed .
BACKGROUND	The objective is to develop a predictive model for determining the risk of CHD , including the value of high sensitivity C-reactive protein ( hsCRP ) , in patients presenting with chest pain with a particular emphasis on resources and information likely to be available in a remote primary health care setting .
METHODS	A prospective , cross-sectional observational study of patients with no prior diagnosis of CHD presenting to a specialist chest pain assessment clinic at Cairns Hospital from November 2012 to May 2013 .
RESULTS	Out of the 163 participants included in the study analyses , a total of 38 were classified as CHD likely ( 23.3 % ( 95 % CI 17.1-30 .6 ) ) .
RESULTS	Logistic regression modelling identified two factors that were independently associated with likely CHD , namely the presence of typical chest pain ( OR 83.7 ( 95 % CI 21.7-322 .1 ) ) and an abnormal baseline ECG ( OR 12.8 ( 95 % CI 1.9-86 .0 ) ) .
CONCLUSIONS	In this study , it was demonstrated that the presence of typical chest pain and an abnormal resting ECG , remain the cornerstone of predicting a subsequent diagnosis of CHD .
CONCLUSIONS	This information is easily accessible in remote primary health care and should be utilised to expedite assessment in patients presenting with symptoms suggestive of CHD .

###26071094
OBJECTIVE	To determine whether ciclosporin is superior to prednisolone for the treatment of pyoderma gangrenosum , a painful , ulcerating skin disease with a poor evidence base for management .
METHODS	Multicentre , parallel group , observer blind , randomised controlled trial .
METHODS	39 UK hospitals , recruiting from June 2009 to November 2012 .
METHODS	121 patients ( 73 women , mean age 54 years ) with clinician diagnosed pyoderma gangrenosum .
METHODS	Clinical diagnosis was revised in nine participants after randomisation , leaving 112 participants in the analysis set ( 59 ciclosporin ; 53 prednisolone ) .
METHODS	Oral prednisolone 0.75 mg/kg/day compared with ciclosporin 4 mg/kg/day , to a maximum dose of 75 and 400 mg/day , respectively .
METHODS	The primary outcome was speed of healing over six weeks , captured using digital images and assessed by blinded investigators .
METHODS	Secondary outcomes were time to healing , global treatment response , resolution of inflammation , self reported pain , quality of life , number of treatment failures , adverse reactions , and time to recurrence .
METHODS	Outcomes were assessed at baseline and six weeks and when the ulcer had healed ( to a maximum of six months ) .
RESULTS	Of the 112 participants , 108 had complete primary outcome data at baseline and six weeks ( 57 ciclosporin ; 51 prednisolone ) .
RESULTS	Groups were balanced at baseline .
RESULTS	The mean ( SD ) speed of healing at six weeks was -0.21 ( 1.00 ) cm ( 2 ) / day in the ciclosporin group compared with -0.14 ( 0.42 ) cm ( 2 ) / day in the prednisolone group .
RESULTS	The adjusted mean difference showed no between group difference ( 0.003 cm ( 2 ) / day , 95 % confidence interval -0.20 to 0.21 ; P = 0.97 ) .
RESULTS	By six months , ulcers had healed in 28/59 ( 47 % ) participants in the ciclosporin group compared with 25/53 ( 47 % ) in the prednisolone group .
RESULTS	In those with healed ulcers , eight ( 30 % ) receiving ciclosporin and seven ( 28 % ) receiving prednisolone had a recurrence .
RESULTS	Adverse reactions were similar for the two groups ( 68 % ciclosporin and 66 % prednisolone ) , but serious adverse reactions , especially infections , were more common in the prednisolone group .
CONCLUSIONS	Prednisolone and ciclosporin did not differ across a range of objective and patient reported outcomes .
CONCLUSIONS	Treatment decisions for individual patients may be guided by the different side effect profiles of the two drugs and patient preference .
CONCLUSIONS	Trial registration Current Controlled Trials ISRCTN35898459 .

###24334959
OBJECTIVE	To assess otolaryngology physician knowledge of and attitudes toward the Patient Protection and Affordable Care Act ( PPACA ) and compare the association of bias toward the PPACA with knowledge of the provisions of the PPACA .
METHODS	Cross-sectional survey .
METHODS	Nationwide assessment .
METHODS	Members of the American Academy of Otolaryngology-Head and Neck Surgery .
METHODS	Otolaryngology physicians answered 10 true/false questions about major provisions of the PPACA .
METHODS	They also indicated their level of agreement with 9 statements about health care and the PPACA .
METHODS	Basic demographic information was collected .
RESULTS	Email solicitation was sent to 9972 otolaryngologists and 647 responses were obtained ( 6.5 % response rate ) .
RESULTS	Overall correct response rate was 74 % .
RESULTS	Fewer than 60 % of physicians correctly answered questions on whether small businesses receive tax credits for providing health insurance , the effect of the PPACA on Medicare benefits , and whether a government-run health insurance plan was created .
RESULTS	Academic center practice setting , bias toward the PPACA , and Democratic Party affiliation were associated with significantly more correct responses .
CONCLUSIONS	Overall physician knowledge of the PPACA is assessed as fair , although better than the general public in 2010 .
CONCLUSIONS	There are several areas where knowledge of physicians regarding the PPACA is poor , and this knowledge deficit is more pronounced within certain subgroups .
CONCLUSIONS	These knowledge issues should be addressed by individual physicians and medical societies .

###24756009
OBJECTIVE	Despite treatment with glucocorticoids , mortality remains high in patients with severe alcoholic hepatitis .
OBJECTIVE	Oxidative stress and depletion of mitochondrial glutathione are implicated factors in liver injury .
OBJECTIVE	The aim of this study was to evaluate the impact of the addition of metadoxine , a drug which possesses a multifactorial mechanism of action , including antioxidant properties , to standard treatment with glucocorticoids in patients with severe alcoholic hepatitis .
METHODS	This randomized open label clinical trial was performed in Mexico 's General Hospital ( Registry Key DIC/10/107 / 03/043 ) .
METHODS	We randomized 70 patients with severe alcoholic hepatitis .
METHODS	The first group received prednisone ( 40 mg/day ) , and the second group received prednisone ( 40 mg/day ) plus metadoxine tablets ( 500 mg three times daily ) .
METHODS	The duration of treatment in both groups was 30 days .
METHODS	Survival at 30 and 90 days , development of complications , adverse events and response to treatment ( Lille model ) were assessed .
RESULTS	In the group receiving metadoxine , significant improvements were observed , as follows : survival at 30 days ( 74.3 vs. 45.7 % , P = 0.02 ) ; survival at 90 days ( 68.6 vs. 20.0 % , P = 0.0001 ) .
RESULTS	There was less development or progression of encephalopathy ( 28.6 vs. 60.0 % , P = 0.008 ) and hepatorenal syndrome ( 31.4 vs. 54.3 % , P = 0.05 ) , and the response to treatment ( Lille model ) was higher in the metadoxine group ( 0.38 vs. 0.63 , P = 0.001 ; 95 % CI 0.11 to 0.40 ) .
RESULTS	There were no differences between groups regarding the development or progression of variceal hemorrhage or infection .
RESULTS	The incidence of adverse events , mainly gastrointestinal , was similar in both groups .
CONCLUSIONS	Addition of metadoxine to glucocorticoid treatment improves the short-term survival of patients with severe alcoholic hepatitis and diminishes the development or progression of encephalopathy and hepatorenal syndrome .

###25599737
BACKGROUND	Kidney transplantation is associated with rapid loss of bone mineral density ( BMD ) in the first months after transplantation .
BACKGROUND	The effect of pamidronate on bone loss after transplantation was evaluated in a randomized controlled trial .
METHODS	Forty patients were enrolled in this study ( 16 in the pamidronate group and 24 in the control group ) .
METHODS	Pamidrinate was administered as 30-mg intravenous infusion within 2 days after transplantation and 3 months later .
METHODS	All of the patients received calcium and vitamin D supplementation .
METHODS	Laboratory parameters and BMD ( lumbar spine and femoral neck ) were measured at baseline and 6 months after kidney transplantation .
RESULTS	Bone mineral density at the initiation of study had no significant differences between the two groups .
RESULTS	In each group , BMD of femoral neck and lumbar spine had no significant differences 6 months after transplantation in comparison to pretransplantation values .
RESULTS	There was no significant difference in BMD changes after intervention between two groups .
RESULTS	Parathyroid hormone level normalized in both of the pamidronate and control groups 6 months after kidney transplantation .
RESULTS	Glomerular filtration rate at the end of study was not significantly different between the two groups .
CONCLUSIONS	Our study suggests that administration of calcium and vitamin D following transplantation may be beneficial to counterbalance the substantial bone loss occurring within 6 months after transplantation , and addition of pamidronate has no beneficial effect in BMD in this short interval after kidney transplantation .

###25045434
OBJECTIVE	To compare the efficacy of metformin plus megestrol acetate ( MA ) with that of MA alone for treating endometrial atypical hyperplasia ( EAH ) .
METHODS	This pilot study included 16 EAH patients who met at least one metabolic syndrome ( MS ) criterion and received either adjunctive metformin plus MA ( MET group ) or MA monotherapy ( MA group ) .
METHODS	Each patient in the MA group received 160 mg of MA daily , whereas patients in the MET group received the same dose of MA plus 0.5 g of metformin thrice daily .
METHODS	Treatment response was assessed by histological examination of dilation and curettage specimens obtained after 12 weeks of therapy .
RESULTS	Each group had eight patients , and half of the patients in each group were diagnosed with MS. The complete response ( CR ) rate was 75 % ( 6/8 ) in the MET group and 25 % ( 2/8 ) in the MA group ( p = 0.105 ) .
RESULTS	Complications of MS did not affect the response rates in either group .
RESULTS	In the MET group , 75 % ( 3/4 ) of the patients had CR in the presence or absence of MS. In the MA group , 50 % ( 2/4 ) of the patients with MS had CR , whereas no patient without MS had CR .
RESULTS	No irreversible toxicities were observed .
CONCLUSIONS	Metformin plus MA may be a potential alternative therapy for treating EAH , and the MS status of patients may have no effect on the efficacy of metformin plus MA therapy .

###24579091
BACKGROUND	Real-time virtual sonography is an innovative imaging technology that detects the spatial position of an ultrasound probe and immediately reconstructs a section of computed tomography ( CT ) and/or magnetic resonance in accordance with the ultrasound image , thereby allowing a real-time comparison of those modalities .
BACKGROUND	A novel intraoperative navigation system for liver resection using real-time virtual sonography has been devised for the detection of tumors and navigation of the resection plane .
METHODS	Sixteen patients with hepatic malignancies ( 26 tumors in total ) were involved in this study , and the system was used intraoperatively .
METHODS	The tumor size ranged 2 to 140 mm ( 23 mm in median ) .
METHODS	By the navigation system , operators could refer intraoperative ultrasound image displayed on the television monitor side-by-side with corresponding images of CT and/or magnetic resonance .
METHODS	In addition , the system overlaid preoperative simulation on the CT image and highlighted the extent of resection so as to navigate the resection plane .
METHODS	Because the system used electromagnetic power in the operation room , the feasibility and safety of the system was investigated as well as its validity .
RESULTS	The system could be used uneventfully in each operation .
RESULTS	All of the 26 tumors scheduled to be resected were detected by the navigation system .
RESULTS	The weight of the resected specimen correlated with the preoperatively simulated volume ( R = 0.995 , P < .0001 ) .
CONCLUSIONS	The feasibility and safety of the navigation system were confirmed .
CONCLUSIONS	The system should be helpful for intraoperative tumor detection and navigation of liver resection .

###25205323
OBJECTIVE	Anemia is a significant public health concern , especially among women and young children .
OBJECTIVE	An improved understanding of the complex etiology of anemia is crucial for developing appropriate prevention strategies .
OBJECTIVE	This paper examines the determinants of anemia in a large sample of Vietnamese women of reproductive age ( WRA ) .
METHODS	We included baseline data from 4986 WRA participating in a randomized controlled trial ( PRECONCEPT ) .
METHODS	Hemoglobin ( Hb ) concentrations were measured with Hemocue .
METHODS	Plasma ferritin ( Fe ) , retinol binding protein ( RBP ) and markers of inflammation were assessed using the ELISA technique .
METHODS	We used multivariate logistic regression to describe associations with anemia and structural equation modeling ( SEM ) to characterize direct and indirect pathways influencing Hb concentrations .
RESULTS	Prevalence of anemia , iron deficiency ( Fe < 12 g/l ) , insufficient iron stores ( Fe < 30 g/l ) and iron deficiency anemia was 19.7 , 3.5 , 14.4 and 1.9 % , respectively .
RESULTS	Ferritin concentration ( 0.29 per log-mg/dl ) , being an ethnic minority ( -0.24 compared with Kinh ) , number of children ( -0.17 ) and socioeconomic status ( 0.09 ) were directly associated with Hb concentration ( P < 0.05 ) .
RESULTS	Similarly , RBP was directly ( 0.27 per mg/dl ) associated with Hb and also indirectly ( 0.09 mg/dl ) with ferritin .
RESULTS	Hookworm infection was indirectly associated with Hb ( -0.11 ) through RBP and ferritin .
CONCLUSIONS	These findings illustrate the complex etiology of anemia and provide a useful framework for designing , targeting and evaluating appropriate strategies for the prevention and control of anemia .
CONCLUSIONS	Contrary to expectations , iron deficiency accounted for a very small proportion of anemia in Northern Vietnam .

###24890623
OBJECTIVE	The recent enormous increase in colonoscopy demand prompted this multicentre observational study assessing overall acceptability and efficacy of commonly used bowel preparations in Italian clinical practice .
METHODS	Consecutive outpatients undergoing colonoscopy were recruited from 9 major gastroenterological centres in Italy .
METHODS	Each patient evaluated overall acceptability of the bowel cleansing preparation through a 0-100mm Visual Analogue Scale .
METHODS	The Visual Analogue Scale score was dichotomized by a median split : 80-100 ( high acceptability ) vs. 0-79 ( low acceptability ) .
METHODS	Bowel cleansing was assessed through a validated scale .
METHODS	The influence of potential individual determinants on patients ' acceptability and cleansing efficacy of the bowel preparations was determined by multivariate analyses .
RESULTS	599 evaluable patients were enrolled ; 57.3 % received 4L-PEG preparations , 29.5 % 2L-PEG preparations and 13.2 % 2-glasses-solutions ( Na-phosphate/Mg-citrate/Na-picosulphate-containing preparations ) .
RESULTS	Overall acceptability was significantly higher for 2L-PEG and 2-glasses solutions than 4L-PEG ( adjusted odds ratio , 4.72 ; and adjusted odds ratio 2.07 , respectively ) .
RESULTS	Successful bowel cleansing achieved with 4L-PEG ( 85.9 % ) was similar to 2L-PEG ( 85.3 % ; adjusted odds ratio 0.82 ) and significantly higher than 2-glasses solutions ( 69.6 % ; adjusted odds ratio 0.34 vs. 4L-PEG ) .
RESULTS	Split regimen , lower total preparation volume and colonoscopy reason ( periodical control vs. 1st procedure ) were significantly associated with high acceptability .
RESULTS	Age 60 years , dissatisfaction with the preparation taken , and 4/week bowel movements were major determinants of a poor bowel cleansing .
CONCLUSIONS	2L-PEG and 4L-PEG preparations provide the most effective bowel cleansing for colonoscopy in clinical practice , with a significantly higher acceptability for 2L-PEG preparations .

###24505281
BACKGROUND	The prognostic importance of anemia for cardiovascular ( CV ) events and mortality has been extensively investigated .
BACKGROUND	However , little is known about the impact of transferrin saturation ( TSAT ) , a marker reflecting the availability of iron for erythropoiesis , on clinical outcome in dialysis patients .
METHODS	A total of 879 anemic incident dialysis patients were recruited from the Clinical Research Center for End-Stage Renal Disease in Korea and were divided into 3 groups according to baseline TSAT of 20 % , 20-40 % , and > 40 % .
RESULTS	There were no differences in hemoglobin levels and the proportion of patients on erythropoiesis-stimulating agents or iron supplements among the 3 groups .
RESULTS	During a mean follow-up duration of 19.3 months , 51 ( 5.8 % ) patients died .
RESULTS	CV composite ( 11.71 vs. 5.55 events/100 patient-years , P = 0.001 ) and all-cause mortality rates ( 5.38 vs. 2.31 events/100 patient-years , P = 0.016 ) were significantly higher in patients with TSAT 20 % compared to those with TSAT 20-40 % ( reference group ) .
RESULTS	Cox regression analysis revealed that patients with TSAT 20 % had 1.62 - and 2.19-fold higher risks for CV composite outcome ( P = 0.046 ) and all-cause mortality ( P = 0.030 ) .
RESULTS	Moreover , TSAT 20 % was significantly associated with left ventricular hypertrophy [ odds ratio ( OR ) = 1.46 ] , high-sensitivity C-reactive protein 3 mg/dL ( OR = 2.09 ) , N-terminal pro B-type natriuretic peptide 10000 pg/mL ( OR = 2.04 ) , and troponin-T0 .1 ng/mL ( OR = 2.02 ) , on logistic regression analysis .
CONCLUSIONS	Low TSAT was a significant independent risk factor for adverse clinical outcome in incident dialysis patients with anemia , which may be partly attributed to cardiac dysfunction and inflammation .

###24565484
BACKGROUND	Auvi-Q is a novel epinephrine autoinjector ( EAI ) that provides audio and visual cues for patients at risk for life-threatening allergic reactions .
OBJECTIVE	We tested the preference for Auvi-Q or EpiPen with regard to method of instruction , preference to carry , device size , and device shape .
METHODS	This large , multicenter , simulated-use study evaluated whether adults ( aged 18-65 years ) , caregivers ( parents/guardians aged 18-65 years of children aged 5-17 years ) , and children ( aged 11-17 years ) , with and without experience in using an EAI , had a preference for the current design of Auvi-Q or the current design of EpiPen .
METHODS	Participants were given a scenario that involved anaphylaxis and were instructed to simulate use of an EAI .
METHODS	They received and tested each device individually according to the randomization assignment .
METHODS	After testing both devices , they completed a survey to indicate their preference for Auvi-Q versus EpiPen .
RESULTS	Among all 693 participants combined , Auvi-Q was preferred over EpiPen on all study end points ( P < .001 ) .
RESULTS	For experienced and inexperienced participants in all 3 groups ( adults , caregivers , and children ) , Auvi-Q was preferred over EpiPen for method of instruction , preference to carry , and device size ( all P < .001 ) .
RESULTS	The preference for Auvi-Q device shape was not significant among experienced children ( P = .10 ) ; however , it was significant for inexperienced children ( P = .04 ) and highly significant for experienced and inexperienced adults and caregivers ( P < .001 ) .
CONCLUSIONS	In this large multicenter , simulated-use study , Auvi-Q was preferred over EpiPen by experienced and inexperienced adults , caregivers , and children .

###26480549
OBJECTIVE	To observe the difference in the clinical efficacy on peripheral facial palsy between electro-acupuncture ( EA ) assisted with surface electromyography ( sEMG ) and conventional EA .
METHODS	Sixty cases of peripheral facial palsy were randomized into an observation group and a control group , 30 cases in each one .
METHODS	EA was applied during the first 15 days of sickness in the two groups , at Xiaguan ( ST 7 ) , Jiache ( ST 6 ) , Dicang ( ST 4 ) , Yangbai ( GB 14 ) , Taiyang ( EX-HN 5 ) , Quanliao ( SI 18 ) and Hegu ( LI 4 ) , once a day .
METHODS	In the observation , group , 15 days after sickness , according to the situation in sEMG , on the basis of the acupoints in the previous treatment , the corresponding acupoints were reselected for EA .
METHODS	In the control group , the conventional EA was kept on .
METHODS	The treatment was given once every two days till the 35th day of sickness .
METHODS	Separately , on the 5th , 15th and 35th days of sickness , according to the detection of sEMG in the patients of two groups , the means ratios of : root mean square ( RMS ) of musculi buccinators , orbicularis oris , frontalis and nasalis on the healthy and affected sides were recorded and analyzed .
RESULTS	The differences of ratio in RMS of musculi buccinators , orbicularis oris , frontalis and nasalis on the healthy and affected sides were significant statistically in comparison between the , 15th day and the 5th day , and between the 35th day and the 15th day of sickness within each group ( all P < 0.01 ) .
RESULTS	The differences of ratio in RMS of the muscles on the healthy and affected sides were significant statistically on the 15th and 35th days between the two groups ( all P < 0.05 ) .
CONCLUSIONS	EA assisted with sEMG achieves the significant efficacy on peripheral facial palsy , better than the conventional EA .

###25304132
OBJECTIVE	Interleukin-13 ( IL-13 ) has been implicated as a key driver of UC .
OBJECTIVE	This trial evaluates the efficacy and safety of tralokinumab , an IL-13-neutralising antibody , as add-on therapy in adults with moderate-to-severe UC despite standard treatments .
METHODS	Non-hospitalised adults with UC ( total Mayo score 6 ) were randomised to receive tralokinumab 300mg or placebo subcutaneously every 2weeks for 12weeks .
METHODS	The primary end point was the rate of clinical response at week 8 .
METHODS	Secondary efficacy end points included clinical remission and mucosal healing rates at week 8 and changes in total Mayo score , total modified Riley score , partial Mayo score and disease activity markers .
RESULTS	Clinical response rate was 38 % ( 21/56 ) for tralokinumab vs. 33 % ( 18/55 ) for placebo ( p = 0.406 ) .
RESULTS	Clinical remission rate was 18 % ( 10/56 ) vs. 6 % ( 3/55 ) ( p = 0.033 ) and mucosal healing rate was 32 % ( 18/56 ) vs. 20 % ( 11/55 ) ( p = 0.104 ) for tralokinumab vs placebo .
RESULTS	Changes to week 8 in total Mayo score and total modified Riley score were similar for tralokinumab and placebo ( least-squares mean difference between groups : -0.49 ( p = 0.394 ) and 0.25 ( p = 0.449 ) , respectively ) .
RESULTS	Partial Mayo score at week 4 was lower with tralokinumab than placebo ( least-squares mean difference between groups : -0.90 ( p = 0.041 ) ) .
RESULTS	No consistent patterns were observed for disease activity markers .
RESULTS	Tralokinumab had an acceptable safety profile .
CONCLUSIONS	Add-on therapy with tralokinumab did not significantly improve clinical response .
CONCLUSIONS	However , the higher clinical remission rate with tralokinumab than placebo suggests that tralokinumab may benefit some patients with UC .
CONCLUSIONS	Tralokinumab was well tolerated .
BACKGROUND	ClinicalTrials.gov number : NCT01482884 .

###24937017
BACKGROUND	Colorectal cancer is the second-leading cause of cancer deaths in the United States .
BACKGROUND	The Strategies and Opportunities to Stop Colorectal Cancer ( STOP CRC ) in Priority Populations study is a pragmatic trial and a collaboration between two research institutions and a network of more than 200 safety net clinics .
BACKGROUND	The study will assess the effectiveness of a system-based intervention designed to improve the rates of colorectal-cancer screening using fecal immunochemical testing ( FIT ) in federally qualified health centers in Oregon and Northern California .
METHODS	STOP CRC is a cluster-randomized comparative-effectiveness pragmatic trial enrolling 26 clinics .
METHODS	Clinics will be randomized to one of two arms .
METHODS	Clinics in the intervention arm ( 1 ) will use an automated , data-driven , electronic health record-embedded program to identify patients due for colorectal screening and mail FIT kits ( with pictographic instructions ) to them ; ( 2 ) will conduct an improvement process ( e.g. Plan-Do-Study-Act ) to enhance the adoption , reach , and effectiveness of the program .
METHODS	Clinics in the control arm will provide opportunistic colorectal-cancer screening to patients at clinic visits .
METHODS	The primary outcomes are : proportion of age - and screening-eligible patients completing a FIT within 12months ; and cost , cost-effectiveness , and return on investment of the intervention .
CONCLUSIONS	This large-scale pragmatic trial will leverage electronic health record information and existing clinic staff to enroll a broad range of patients , including many with historically low colorectal-cancer screening rates .
CONCLUSIONS	If successful , the program will provide a model for a cost-effective and scalable method to raise colorectal-cancer screening rates .

###24962144
OBJECTIVE	To compare the effect of monovision correction and multifocal intraocular lens ( IOL ) implantation on patient satisfaction , spectacle dependence , visual acuity , and dysphotopsia in cataract patients .
METHODS	University Hospital of Alexandroupolis , Democritus University of Thrace , Alexandroupolis , Greece .
METHODS	Prospective randomized trial .
METHODS	Patients with a diagnosis of senile cataract with stage 2 nuclear opalescence were randomly assigned to 2 groups : monovision and multifocal IOL implantation .
METHODS	Uncorrected ( UDVA ) and corrected ( CDVA ) distance visual acuity , Visual Function Index-14 ( VF-14 ) scores , and spectacle dependence were assessed prior to surgery and 6 months postoperatively .
RESULTS	The monovision group comprised 38 patients and the multifocal IOL implantation group , 37 patients .
RESULTS	Both techniques provided excellent refractive outcomes in UDVA and VF-14 scores ( all P < .01 ) .
RESULTS	No significant intergroup differences were detected in VF-14 scores at the final postoperative examination .
RESULTS	The monovision group patients presented significantly more spectacle dependence for near vision but less glare .
CONCLUSIONS	Monovision and multifocal IOL implantation provided excellent refractive outcomes for distance vision .
CONCLUSIONS	Multifocal IOL insertion was associated with less dependence on glasses overall but significantly more dysphotopsia .
BACKGROUND	No author has a financial or proprietary interest in any material or method mentioned .

###26317258
BACKGROUND	This pilot study was set up to examine the effects of a continuous postoperative wound infusion system with a local anaesthetic on perioperative pain and the consumption of analgesics .
METHODS	We included 42 patients in this prospective observational pilot study .
METHODS	Patients were divided into two groups .
METHODS	One group was treated in accordance with the WHO standard pain management protocol and in addition to that received a continuous local wound infusion treatment ( Group 1 ) .
METHODS	Group 2 was treated with analgesics in accordance with the WHO standard pain management protocol , exclusively .
RESULTS	The study demonstrated a significantly reduced postoperative VAS score for stump pain in Group 1 for the first 5 days .
RESULTS	Furthermore , the intake of opiates was significantly reduced in Group 1 ( day 1 , Group 1 : 42.1 vs. Group 2 : 73.5 , p = 0.010 ; day 2 , Group 1 : 27.7 vs. Group 2 : 52.5 , p = 0.012 ; day 3 , Group 1 : 23.9 vs. Group 2 : 53.5 , p = 0.002 ; day 4 , Group 1 : 15.7 vs. Group 2 : 48.3 , p = 0.003 ; day 5 , Group 1 13.3 vs. Group 2 : 49.9 , p = 0.001 ) .
RESULTS	There were no significant differences between the two groups , neither in phantom pain intensity at discharge nor postoperative complications and death .
CONCLUSIONS	Continuous postoperative wound infusion with a local anaesthetic in combination with a standard pain management protocol can reduce both stump pain and opiate intake in patients who have undergone transfemoral amputation .
CONCLUSIONS	Phantom pain was not significantly affected .

###24630848
BACKGROUND	Responses to a number of different plasticity-inducing brain stimulation protocols are highly variable .
BACKGROUND	However there is little data available on the variability of response to transcranial direct current stimulation ( TDCS ) .
OBJECTIVE	We tested the effects of TDCS over the motor cortex on corticospinal excitability .
OBJECTIVE	We also examined whether an individual 's response could be predicted from measurements of onset latency of motor evoked potential ( MEP ) following stimulation with different orientations of monophasic transcranial magnetic stimulation ( TMS ) .
METHODS	Fifty-three healthy subjects participated in a crossover-design .
METHODS	Baseline latency measurements with different coil orientations and MEPs were recorded from the first dorsal interosseous muscle prior to the application of 10 min of 2 mA TDCS ( 0.057 mA/cm2 ) .
METHODS	Thirty MEPs were measured every 5 min for up to half an hour after the intervention to assess after-effects on corticospinal excitability .
RESULTS	Anodal TDCS at 2 mA facilitated MEPs whereas there was no significant effect of 2 mA cathodal TDCS .
RESULTS	A two-step cluster analysis suggested that approximately 50 % individuals had only a minor , or no response to TDCS whereas the remainder had a facilitatory effect to both forms of stimulation .
RESULTS	There was a significant correlation between the latency difference of MEPs ( anterior-posterior stimulation minus latero-medial stimulation ) and the response to anodal , but not cathodal TDCS .
CONCLUSIONS	The large variability in response to these TDCS protocols is in line with similar studies using other forms of non-invasive brain stimulation .
CONCLUSIONS	The effects highlight the need to develop more robust protocols , and understand the individual factors that determine responsiveness .

###24785989
OBJECTIVE	To evaluate the efficacy and safety of solifenacin in the management of irritative symptoms after transurethral resection of bladder tumors ( TURBTs ) with subsequent intravesical chemotherapy .
METHODS	A total of 116 patients undergoing TURBT were randomly allocated into 2 groups , 58 patients in each group .
METHODS	Group 1 patients received solifenacin 5 mg , 6 hours before surgery and 5 mg per day , after surgery for 2 weeks , whereas group 2 patients received a placebo .
METHODS	Patients with low-risk non-muscle-invasive bladder cancer received immediate postoperative instillation of epirubicin .
METHODS	Patients with medium - or high-risk non-muscle-invasive bladder cancer received postoperative instillation twice within 2 weeks , once immediately following the operation and once on the eighth postoperative day .
METHODS	All patients completed bladder diaries before surgery , on the 1st , 7th , and 14th days after removal of the catheter with overactive bladder symptom scores completed preoperatively , and on the 7th and 14th days .
METHODS	Additionally , the incidence and severity of catheter-related bladder discomfort were recorded at 6 , 12 , 24 , 48 , and 72 hours after the surgery .
RESULTS	The incidence and the severity of catheter-related bladder discomfort in group 1 , compared with group 2 , were significantly reduced ( P < .05 ) .
RESULTS	There was a significant difference in overactive bladder symptom scores between the 2 groups ( 5.67 vs 7.86 ; P < .001 ) .
RESULTS	Episodes of daytime , frequency , nocturia , urgency , and urge urinary incontinence in group 1 were also significantly lower than in group 2 ( P < .05 ) .
CONCLUSIONS	This study demonstrates that solifenacin can be beneficial for the management of irritative symptoms after TURBT with subsequent intravesical chemotherapy .

###25456367
BACKGROUND	Oxaliplatin-based adjuvant therapy is the standard of care for stage III colon cancer .
BACKGROUND	Adjuvant capecitabine with or without oxaliplatin versus leucovorin and fluorouracil with or without oxaliplatin has not been directly compared ; therefore , we aimed to analyse the efficacy and safety of these treatments using individual patient data pooled from four randomised controlled trials .
BACKGROUND	We also assessed post-relapse survival , which has been postulated to be worse in patients receiving adjuvant oxaliplatin .
METHODS	Patients with resected stage III colon cancer who were 18 years of age or older , with an Eastern Cooperative Oncology Group performance status of 0 or 1 , from four randomised controlled trials ( NSABP C-08 , XELOXA , X-ACT , and AVANT ; 8734 patients in total ) were pooled and analysed .
METHODS	The treatment regimens included in our analyses were : XELOX ( oxaliplatin and capecitabine ) ; leucovorin and fluorouracil ; capecitabine ; FOLFOX-4 ( leucovorin , fluorouracil , and oxaliplatin ) ; and modified FOLFOX-6 ( mFOLFOX-6 ) .
METHODS	Disease-free survival was the primary endpoint for all trials that supplied patients for this analysis .
METHODS	Here , we compared disease-free , relapse-free , and overall survival between the patient groups who received capecitabine with or without oxaliplatin and those who received leucovorin and fluorouracil with or without oxaliplatin .
METHODS	Post-relapse survival was compared between the combined XELOX and FOLFOX groups , and the leucovorin and fluorouracil groups .
METHODS	Post-relapse survival was also compared between the capecitabine with or without oxaliplatin and leucovorin and fluorouracil with or without oxaliplatin groups .
RESULTS	Disease-free survival did not differ significantly between patients who received leucovorin and fluorouracil versus those who received capecitabine in adjusted analyses ( hazard ratio [ HR ] 102 [ 093-111 ; p = 072 ] ) or in unadjusted analyses ( HR 101 [ 95 % CI 092-110 ; p = 086 ] ) .
RESULTS	Relapse-free survival was similar ( adjusted HR 102 [ 093-112 ; p = 072 ] and unadjusted HR 101 [ 95 % CI 092-111 ; p = 086 ] ) , as was overall survival ( adjusted HR 104 [ 95 % CI 093-115 ; p = 050 ] and unadjusted HR 102 [ 092-114 ] ; p = 065 ) .
RESULTS	For overall survival , a significant interaction between oxaliplatin and fluoropyrimidine was recorded in the multiple Cox regression analysis ( p = 0014 ) .
RESULTS	Post-relapse survival was similar in adjusted ( p = 023 ) and unadjusted analyses ( p = 033 ) for the comparison of XELOX or FOLFOX versus leucovorin and fluorouracil , and was also similar for capecitabine-based regimens versus leucovorin and fluorouracil-based regimens ( unadjusted p = 026 ) .
CONCLUSIONS	Combination therapy with oxaliplatin provided consistently improved outcomes without adversely affecting post-relapse survival in the adjuvant treatment of stage III colon cancer , irrespective of whether the fluoropyrimidine backbone was capecitabine or leucovorin and fluorouracil .
CONCLUSIONS	These data add to the existing evidence that oxaliplatin plus capecitabine or leucovorin and fluorouracil is the standard of care for the adjuvant treatment of stage III colon cancer , and offers physicians flexibility to treat patients according to the patients ' overall physical performance and preference .
BACKGROUND	Genentech Inc. .

###25034315
OBJECTIVE	To determine the effect of vitamin D3 supplementation on 25-hydroxyvitamin D [ 25 ( OH ) D ] , lipid profile and markers of insulin resistance in obese adolescents .
METHODS	In this double-blind , randomized , placebo-controlled trial , 58 obese adolescents ( n = 58 ; 12-18 years of age ) received either vitamin D3 ( 2,000 IU/day ) or placebo for 12 weeks .
METHODS	Total 25 ( OH ) D , fasting plasma glucose , insulin and lipid profile were measured at baseline and following supplementation .
RESULTS	The trial was completed by 44/58 enrolled participants .
RESULTS	At the end of the 12 weeks , total serum 25 ( OH ) D concentrations increased to a modest degree ( median 6 ng/ml ) in the vitamin D-supplemented group ( p < 0.001 ) .
RESULTS	Supplementation showed no detectable changes in fasting plasma glucose , insulin , homeostatic model of assessment index ( HOMA-IR ) , lipids and highly sensitive C-reactive protein .
CONCLUSIONS	12 weeks of vitamin D3 supplementation in obese adolescents with 2,000 IU once daily resulted in a modest increase in 25 ( OH ) D concentration in obese adolescents , but did not affect the lipid profile and markers of insulin resistance and inflammation .
CONCLUSIONS	Further studies with higher doses of vitamin D3 and/or longer duration of supplementation are needed to understand if vitamin D3 supplementation can impact lipid profiles and markers of insulin resistance and inflammation in obese children .

###24464736
OBJECTIVE	Device-based pacing-induced diaphragmatic stimulation ( PIDS ) may have therapeutic potential for chronic heart failure ( HF ) patients .
OBJECTIVE	We studied the effects of PIDS on cardiac function and functional outcomes .
RESULTS	In 24 chronic HF patients with CRT , an additional electrode was attached to the left diaphragm .
RESULTS	Randomized into two groups , patients received the following PIDS modes for 3weeks in a different sequence : ( i ) PIDS off ( control group ) ; ( ii ) PIDS 0ms mode ( PIDS simultaneously with ventricular CRT pulse ) ; or ( iii ) PIDS optimized mode ( PIDS with optimized delay to ventricular CRT pulse ) .
RESULTS	For PIDS optimization , acoustic cardiography was used .
RESULTS	Effects of each PIDS mode on dyspnoea , power during exercise testing , and LVEF were assessed .
RESULTS	Dyspnoea improved with the PIDS 0ms mode ( P = 0.057 ) and the PIDS optimized mode ( P = 0.034 ) as compared with the control group .
RESULTS	Maximal power increased from median 100.5 W in the control group to 104.0 W in the PIDS 0ms mode ( P = 0.092 ) and 109.5 W in the PIDS optimized mode ( P = 0.022 ) .
RESULTS	Median LVEF was 33.5 % in the control group , 33.0 % in the PIDS 0ms mode , and 37.0 % in the PIDS optimized mode ( P = 0.763 and P = 0.009 as compared with the control group , respectively ) .
RESULTS	PIDS was asymptomatic in all patients .
CONCLUSIONS	PIDS improves dyspnoea , working capacity , and LVEF in chronic HF patients over a 3 week period in addition to CRT .
CONCLUSIONS	This pilot study demonstrates proof of principle of an innovative technology which should be confirmed in a larger sample .
BACKGROUND	NCT00769678 .

###25281655
BACKGROUND	Outcomes associated with episodes of hypotension while hospitalized with acute decompensated heart failure are not well understood .
RESULTS	Using data from Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure ( ASCEND-HF ) , we assessed factors associated with in-hospital hypotension and subsequent 30-day outcomes .
RESULTS	Patients were classified as having symptomatic or asymptomatic hypotension .
RESULTS	Multivariable logistic regression was used to determine factors associated with in-hospital hypotension , and Cox proportional hazards models were used to assess the association between hypotension and 30-day outcomes .
RESULTS	We also tested for treatment interaction with nesiritide on 30-day outcomes and the association between in-hospital hypotension and renal function at hospital discharge .
RESULTS	Overall , 1555 of 7141 ( 21.8 % ) patients had an episode of hypotension , of which 73.1 % were asymptomatic and 26.9 % were symptomatic .
RESULTS	Factors strongly associated with in-hospital hypotension included randomization to nesiritide ( odds ratio , 1.98 ; 95 % confidence interval [ CI ] , 1.76-2 .23 ; P < 0.001 ) , chronic metolazone therapy ( odds ratio , 1.74 ; 95 % CI , 1.17-2 .60 ; P < 0.001 ) , and baseline orthopnea ( odds ratio , 1.31 ; 95 % CI , 1.13-1 .52 ; P = 0.001 ) or S3 gallop ( odds ratio , 1.21 ; 95 % CI , 1.06-1 .40 ; P = 0.006 ) .
RESULTS	In-hospital hypotension was associated with increased hazard of 30-day mortality ( hazard ratio , 2.03 ; 95 % CI , 1.57-2 .61 ; P < 0.001 ) , 30-day heart failure hospitalization or mortality ( hazard ratio , 1.58 ; 95 % CI , 1.34-1 .86 ; P < 0.001 ) , and 30-day all-cause hospitalization or mortality ( hazard ratio , 1.40 ; 95 % CI , 1.22-1 .61 ; P < 0.001 ) .
RESULTS	Nesiritide had no interaction on the relationship between hypotension and 30-day outcomes ( interaction P = 0.874 for death , P = 0.908 for death/heart failure hospitalization , P = 0.238 death/all-cause hospitalization ) .
CONCLUSIONS	Hypotension while hospitalized for acute decompensated heart failure is an independent risk factor for adverse 30-day outcomes , and its occurrence highlights the need for modified treatment strategies .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00475852 .

###25349301
OBJECTIVE	There is a lack of treatments providing survival benefit for patients with metastatic triple-negative breast cancer ( mTNBC ) , with no standard of care .
OBJECTIVE	A randomized phase II trial showed significant benefit for gemcitabine , carboplatin , and iniparib ( GCI ) over gemcitabine and carboplatin ( GC ) in clinical benefit rate , response rate , progression-free survival ( PFS ) , and overall survival ( OS ) .
OBJECTIVE	Here , we formally compare the efficacy of these regimens in a phase III trial .
METHODS	Patients with stage IV/locally recurrent TNBC who had received no more than two previous chemotherapy regimens for mTNBC were randomly allocated to gemcitabine 1,000 mg/m ( 2 ) and carboplatin area under the curve 2 ( days 1 and 8 ) alone or GC plus iniparib 5.6 mg/kg ( days 1 , 4 , 8 , and 11 ) every 3 weeks .
METHODS	Random assignment was stratified by the number of prior chemotherapies .
METHODS	The coprimary end points were OS and PFS .
METHODS	Patients receiving GC could cross over to iniparib on progression .
RESULTS	Five hundred nineteen patients were randomly assigned ( 261 GCI ; 258 GC ) .
RESULTS	In the primary analysis , no statistically significant difference was observed for OS ( hazard ratio [ HR ] = 0.88 ; 95 % CI , 0.69 to 1.12 ; P = .28 ) nor PFS ( HR = 0.79 ; 95 % CI , 0.65 to 0.98 ; P = .027 ) .
RESULTS	An exploratory analysis showed that patients in the second - / third-line had improved OS ( HR = 0.65 ; 95 % CI , 0.46 to 0.91 ) and PFS ( HR = 0.68 ; 95 % CI , 0.50 to 0.92 ) with GCI .
RESULTS	The safety profile for GCI was similar to GC .
CONCLUSIONS	The trial did not meet the prespecified criteria for the coprimary end points of PFS and OS in the ITT population .
CONCLUSIONS	The potential benefit with iniparib observed in second - / third-line subgroup warrants further evaluation .

###25663605
OBJECTIVE	Supposing divergent aetiology , we found it interesting to investigate outcomes between primary ( PH ) versus incisional ( IH ) hernias .
OBJECTIVE	In addition , we wanted to analyse the effect of defect closure and mesh fixation techniques .
METHODS	37 patients with PH and 70 with IH were enrolled in a prospective cohort-study , treated with laparoscopic ventral hernia repair ( LVHR ) and randomised to transfascial sutures .
METHODS	In addition , we analysed results from a retrospective study with 36 PH and 51 IH patients .
METHODS	Mean follow-up time was 38 months in the prospective study and 27 months in the retrospective study .
RESULTS	35 % of PH 's and 10 % of IH 's were recurrences after previous suture repair .
RESULTS	No late infections or mesh removals occurred .
RESULTS	Recurrence rates in the prospective study were 0 vs. 4.3 % ( p = 0.55 ) and the complication rates were 16 vs. 27 % ( p = 0.24 ) in favour of the PH cohort .
RESULTS	The IH group had a mesh protrusion rate of 13 vs. 5 % in the PH group ( p = 0.32 ) , and significantly ( p < 0.01 ) larger hernias and adhesion score , longer operating time ( 100 vs. 79 min ) and admission time ( 2.8 vs. 1.6 days ) .
RESULTS	Closure of the hernia defect did not influence rate of seroma , pain at 2 months , protrusion or recurrence .
RESULTS	An overall increased complication rate was seen after defect closure ( OR 3.42 ; CI 1.25-9 .33 ) .
CONCLUSIONS	With PH , in comparison to IH treated with LVHR , no differences were observed regarding recurrence , protrusion or complication rates .
CONCLUSIONS	Defect closure ( raphe ) , when using absorbable suture , did not benefit long-term outcomes and caused a higher overall complication rate .
CONCLUSIONS	( ClinicalTrials.gov number : NCT00455299 ) .

###24511022
BACKGROUND	S-1-based regimens are commonly used for advanced gastric cancer ( AGC ) in Japan .
BACKGROUND	We performed this trial to evaluate the efficacy and safety of S-1 plus irinotecan ( SIri ) and S-1 plus paclitaxel ( SPac ) as first-line treatments for AGC in order to select the optimal regimen for a subsequent phase III trial .
METHODS	Patients with previously untreated , locally advanced or metastatic measurable gastric adenocarcinoma were randomly assigned to receive SIri ( irinotecan 80 mg/m ( 2 ) was administered intravenously ( i.v. ) on day 1 and 15 , while 40 mg/m ( 2 ) S-1 was orally administered twice daily for three weeks from days 1-21 followed by a two-week pause ) or SPac ( paclitaxel 50 mg/m ( 2 ) was administered i.v. on day 1 and 8 , while 40 mg/m ( 2 ) S-1 was orally administered twice daily for two weeks from day 1-14 followed by a one-week pause ) regimen .
METHODS	The primary end-point was the overall response rate ( ORR ) , and the secondary end-points were progression-free survival ( PFS ) , overall survival ( OS ) , and toxicity .
RESULTS	A total of 102 patients were enrolled .
RESULTS	The ORR was 33.3 % for SIri and 31.4 % for SPac , which did not achieved the predicted ORR in either group .
RESULTS	PFS and OS were 5.7 and 12.4 months for SIri , 4.6 and 11.9 months for SPac respectively .
RESULTS	No treatment-related deaths occurred during the study .
RESULTS	Although grade 3/4 neutropenia and anemia were more frequent in the Siri group , both regimens were well-tolerated .
CONCLUSIONS	Both regimens were well-tolerated in patients with AGC , but we conclude that neither regimen was optimal for a phase III trial .

###24961377
BACKGROUND	Population-based studies on aspirin-intolerant asthma ( AIA ) are very few , and no previous population study has investigated risk factors for the condition .
OBJECTIVE	To investigate the prevalence and risk factors of AIA in the general population .
METHODS	A questionnaire on respiratory health was mailed to 30,000 randomly selected subjects aged 16-75 years in West Sweden , 29,218 could be traced and 18,087 ( 62 % ) responded .
METHODS	The questionnaire included questions on asthma , respiratory symptoms , aspirin-induced dyspnoea and possible determinants .
RESULTS	The prevalence of AIA was 0.5 % , 0.3 % in men and 0.6 % in women ( P = 0.014 ) .
RESULTS	Sick leave , emergency visits due to asthma and all investigated lower respiratory symptoms were more common in AIA than in aspirin-tolerant asthma ( ATA ) .
RESULTS	Obesity was a strong risk factor for AIA ( BMI > 35 : odds ratio ( OR ) 12.1 ; 95 % CI 2.49-58 .5 ) , and there was a dose-response relationship between increasing body mass index ( BMI ) and risk of AIA .
RESULTS	Obesity , airborne occupational exposure and visible mould at home were considerably stronger risk factors for AIA than for ATA .
RESULTS	Current smoking was a risk factor for AIA ( OR 2.55 ; 95 % CI 1.47-4 .42 ) , but not ATA .
CONCLUSIONS	Aspirin-intolerant asthma identified in the general population was associated with a high burden of symptoms , uncontrolled disease and a high morbidity .
CONCLUSIONS	Increasing BMI increased the risk of AIA in a dose-response manner .
CONCLUSIONS	A number of risk factors , including obesity and current smoking , were considerably stronger for AIA than for ATA .

###24761921
BACKGROUND	Statistical methods are very important to precisely measure breast cancer patient survival times for healthcare management .
BACKGROUND	Previous studies considered basic statistics to measure survival times without incorporating statistical modeling strategies .
BACKGROUND	The objective of this study was to develop a data-based statistical probability model from the female breast cancer patients ' survival times by using the Bayesian approach to predict future inferences of survival times .
METHODS	A random sample of 500 female patients was selected from the Surveillance Epidemiology and End Results cancer registry database .
METHODS	For goodness of fit , the standard model building criteria were used .
METHODS	The Bayesian approach is used to obtain the predictive survival times from the data-based Exponentiated Exponential Model .
METHODS	Markov Chain Monte Carlo method was used to obtain the summary results for predictive inference .
RESULTS	The highest number of female breast cancer patients was found in California and the lowest in New Mexico .
RESULTS	The majority of them were married .
RESULTS	The mean ( SD ) age at diagnosis ( in years ) was 60.92 ( 14.92 ) .
RESULTS	The mean ( SD ) survival time ( in months ) for female patients was 90.33 ( 83.10 ) .
RESULTS	The Exponentiated Exponential Model found better fits for the female survival times compared to the Exponentiated Weibull Model .
RESULTS	The Bayesian method is used to obtain predictive inference for future survival times .
CONCLUSIONS	The findings with the proposed modeling strategy will assist healthcare researchers and providers to precisely predict future survival estimates as the recent growing challenges of analyzing healthcare data have created new demand for model-based survival estimates .
CONCLUSIONS	The application of Bayesian will produce precise estimates of future survival times .

###25401463
OBJECTIVE	Improvement has been anecdotally observed in patients with persistent postconcussion symptoms ( PCS ) after mild traumatic brain injury following treatment with hyperbaric oxygen ( HBO ) .
OBJECTIVE	The effectiveness of HBO as an adjunctive treatment for PCS is unknown to date .
OBJECTIVE	To compare the safety of and to estimate the efficacy for symptomatic outcomes from standard PCS care alone , care supplemented with HBO , or a sham procedure .
METHODS	Multicenter , double-blind , sham-controlled clinical trial of 72 military service members with ongoing symptoms at least 4 months after mild traumatic brain injury enrolled at military hospitals in Colorado , North Carolina , California , and Georgia between April 26 , 2011 , and August 24 , 2012 .
METHODS	Assessments occurred before randomization , at the midpoint , and within 1 month after completing the interventions .
METHODS	Routine PCS care was provided in specialized clinics .
METHODS	In addition , participants were randomized 1:1:1 to 40 HBO sessions administered at 1.5 atmospheres absolute ( ATA ) , 40 sham sessions consisting of room air at 1.2 ATA , or no supplemental chamber procedures .
METHODS	The Rivermead Post-Concussion Symptoms Questionnaire ( RPQ ) served as the primary outcome measure .
METHODS	A change score of at least 2 points on the RPQ-3 subscale ( range , 0-12 ) was defined as clinically significant .
METHODS	Change scores from baseline were calculated for the RPQ-3 and for the total RPQ .
METHODS	Secondary measures included additional patient-reported outcomes and automated neuropsychometric testing .
RESULTS	On average , participants had sustained 3 lifetime mild traumatic brain injuries ; the most recent occurred 23 months before enrollment .
RESULTS	No differences were observed between groups for improvement of at least 2 points on the RPQ-3 subscale ( 25 % in the no intervention group , 52 % in the HBO group , and 33 % in the sham group ; P = .24 ) .
RESULTS	Compared with the no intervention group ( mean change score , 0.5 ; 95 % CI , -4.8 to 5.8 ; P = .91 ) , both groups undergoing supplemental chamber procedures showed improvement in symptoms on the RPQ ( mean change score , 5.4 ; 95 % CI , -0.5 to 11.3 ; P = .008 in the HBO group and 7.0 ; 95 % CI , 1.0-12 .9 ; P = .02 in the sham group ) .
RESULTS	No difference between the HBO group and the sham group was observed ( P = .70 ) .
RESULTS	Chamber sessions were well tolerated .
CONCLUSIONS	Among service members with persistent PCS , HBO showed no benefits over sham compressions .
CONCLUSIONS	Both intervention groups demonstrated improved outcomes compared with PCS care alone .
CONCLUSIONS	This finding suggests that the observed improvements were not oxygen mediated but may reflect nonspecific improvements related to placebo effects .
BACKGROUND	clinicaltrials.gov Identifier : NCT01306968 .

###25265392
OBJECTIVE	We tested the effect of dietary advice dedicated to increase intake in older patients at risk for malnutrition during chemotherapy , versus usual care , on one-year mortality .
METHODS	We conducted a multicentre , open-label interventional , stratified ( centre ) , parallel randomised controlled trial , with a 11 ratio , with two-year follow-up .
METHODS	Patients were aged 70 years or older treated with chemotherapy for solid tumour and at risk of malnutrition ( MNA , Mini Nutritional Assessment 17-23 .5 ) .
METHODS	Intervention consisted of diet counselling with the aim of achieving an energy intake of 30 kCal/kg body weight/d and 1.2 g protein/kg/d , by face-to-face discussion targeting the main nutritional symptoms , compared to usual care .
METHODS	Interviews were performed 6 times during the chemotherapy sessions for 3 to 6 months .
METHODS	The primary endpoint was 1-year mortality and secondary endpoints were 2-year mortality , toxicities and chemotherapy outcomes .
RESULTS	Between April 2007 and March 2010 we randomised 341 patients and 336 were analysed : mean ( standard deviation ) age of 78.0 y ( 49 ) , 51.2 % male , mean MNA 20.2 ( 2.1 ) .
RESULTS	Distribution of cancer types was similar in the two groups ; the most frequent were colon ( 22.4 % ) , lymphoma ( 14.9 % ) , lung ( 10.4 % ) , and pancreas ( 17.0 % ) .
RESULTS	Both groups increased their dietary intake , but to a larger extent with intervention ( p < 0.01 ) .
RESULTS	At the second visit , the energy target was achieved in 57 ( 40.4 % ) patients and the protein target in 66 ( 46.8 % ) with the intervention compared respectively to 13 ( 13.5 % ) and 20 ( 20.8 % ) in the controls .
RESULTS	Death occurred during the first year in 143 patients ( 42.56 % ) , without difference according to the intervention ( p = 0.79 ) .
RESULTS	No difference in nutritional status changes was found .
RESULTS	Response to chemotherapy was also similar between the groups .
CONCLUSIONS	Early dietary counselling was efficient in increasing intake but had no beneficial effect on mortality or secondary outcomes .
CONCLUSIONS	Cancer cachexia antianabolism may explain this lack of effect .
BACKGROUND	ClinicalTrials.gov NCT00459589 .

###25340318
BACKGROUND	The World Health Organization recommends 36 months of isoniazid preventive therapy ( 36IPT ) for adults infected with HIV living in TB-endemic countries .
BACKGROUND	We determined the rates and risk factors for isoniazid-associated hepatitis with the use of 36IPT .
METHODS	One thousand six adults infected with HIV received 36IPT during a pragmatic randomized trial set in Botswana public health clinics providing HIV care .
METHODS	Enrollment exclusion criteria included jaundice or elevations of serum transaminases ( ESTs ) > 2.5-fold the upper limit of normal ( ULN ) .
METHODS	Participants with any CD4 + lymphocyte count were eligible and received antiretroviral therapy ( ART ) when CD4 + < 200 cells/L .
METHODS	36IPT was stopped for severe hepatitis ( more than fivefold ULN EST ) but not for moderate hepatitis ( 2.5-fold to fivefold ULN EST ) .
RESULTS	Pharmacy refill records showed 2,237 person-years of isoniazid receipt ; 48 % of participants initiated ART by 36 months .
RESULTS	A total of 1.9 % ( 19 of 1,006 ) of participants were diagnosed with severe hepatitis ; three had jaundice and two of these developed hepatic encephalopathy .
RESULTS	Another 3.1 % ( 31 of 1,006 ) of participants experienced moderate hepatitis .
RESULTS	Thirty-eight percent ( 19 of 50 ) of participants with moderate to severe hepatitis concomitantly received ART .
RESULTS	Forty percent ( 20 of 50 ) of moderate to severe cases occurred within the first 2 months of IPT and during this period were not associated with receipt of ART at baseline ( hazard ratio , 1.49 ; 95 % CI , 0.20-11 .1 ; P = .70 ) .
CONCLUSIONS	Adults infected with HIV receiving 36IPT did not have an increased incidence of moderate to severe hepatitis or hepatic encephalopathy compared with published reports among people infected with HIV , people not infected with HIV in trials or public health programs .
CONCLUSIONS	Compared with participants not receiving ART , the risk of moderate to severe hepatitis was not increased by ART .
BACKGROUND	ClinicalTrials.gov ; No. : NCT00164281 ; URL : www.clinicaltrials.gov .

###25288141
OBJECTIVE	A disproportionate number of impoverished and minority children have asthma and receive suboptimal preventive care .
OBJECTIVE	To evaluate whether the Prompting Asthma Intervention in Rochester-Uniting Parents and Providers ( PAIR-UP ) intervention , administered in primary care offices , improves the delivery of preventive care and reduces morbidity for urban children with asthma .
METHODS	Cluster randomized trial in which 12 urban primary care practices were matched based on size and type and randomly allocated to the PAIR-UP intervention or usual care ( UC ) .
METHODS	We enrolled 638 children aged 2 to 12 years with persistent or poorly controlled asthma in the waiting room prior to a visit with a clinician for any reason from October 2009 to January 2013 .
METHODS	Blinded interviewers called caregivers within 2 weeks to inquire about preventive measures taken at the visit and called them 2 and 6 months later to assess symptoms .
METHODS	Children enrolled at PAIR-UP practices received prompts for the caregiver and clinician at the time of the visit that outlined the child 's asthma severity or control as well as specific guideline-based recommendations to enhance preventive care .
METHODS	These practices also received educational resources and periodic feedback on their asthma care performance .
METHODS	The UC practices received copies of the asthma guidelines .
METHODS	The primary outcome was symptom-free days ( SFDs ) per 2 weeks at the 2-month follow-up .
RESULTS	We enrolled 638 children ( participation rate of 80 % ; 36 % were black , 36 % were Hispanic , and 68 % had Medicaid insurance ) .
RESULTS	Groups were similar in demographic characteristics and asthma severity at baseline .
RESULTS	At the index visit , more children in the PAIR-UP group received a preventive medication action ( new medication , increased dose , recommendation to restart preventive medication ) than in the UC group ( 58 % vs 33 % ; odds ratio [ OR ] = 2.8 ; 95 % CI , 1.9 to 3.9 ) .
RESULTS	More children in the PAIR-UP group than in the UC group received an asthma action plan ( 61 % vs 23 % ; OR = 8.3 ; 95 % CI , 3.7 to 18.7 ) , discussions regarding asthma ( 93 % vs 78 % ; OR = 4.5 ; 95 % CI , 2.8 to 7.2 ) , and secondhand smoke counseling ( 80 % vs 63 % ; OR = 2.6 ; 95 % CI , 1.2 to 5.5 ) .
RESULTS	At the 2-month follow-up , children in the PAIR-UP group had more SFDs per 2 weeks than those in the UC group ( mean difference , 0.78 days ; 95 % CI , 0.29 to 1.27 ) .
RESULTS	At 6 months , the improvement in SFDs was no longer statistically significant ( mean difference , 0.56 ; 95 % CI , -0.14 to 1.25 ) .
CONCLUSIONS	The PAIR-UP intervention improved the delivery of preventive asthma care and reduced asthma morbidity for high-risk urban children with persistent asthma at 2 months , but the improvement in SFDs was no longer significant at 6 months .
BACKGROUND	clinicaltrials.gov Identifier : NCT01105754 .

###24245948
BACKGROUND	The best treatment option for end-stage renal disease is usually a transplant , preferably a live donor kidney transplant ( LDKT ) .
BACKGROUND	The most effective ways to educate kidney transplant candidates about the risks , benefits , and process of LDKT remain unknown .
METHODS	We report the protocol of the Enhancing Living Donor Kidney Transplant Education ( ELITE ) Study , a cluster randomized trial of an educational intervention to be implemented during initial transplant evaluation at a large , suburban U.S. transplant center .
METHODS	Five hundred potential transplant candidates are cluster randomized ( by date of visit ) to receive either : ( 1 ) standard-of-care ( `` usual '' ) transplant education , or ( 2 ) intensive education that is based upon the Explore Transplant series of educational materials .
METHODS	Intensive transplant education includes viewing an educational video about LDKT , receiving print education , and meeting with a transplant educator .
METHODS	The primary outcome consists of knowledge of the benefits , risks , and process of LDKT , assessed one week after the transplant evaluation .
METHODS	As a secondary outcome , knowledge and understanding of LDKT are assessed 3 months after the evaluation .
METHODS	Additional secondary outcomes , assessed one week and 3 months after the evaluation , include readiness , self-efficacy , and decisional balance regarding transplant and LDKT , with differences assessed by race .
METHODS	Although the unit of randomization is the date of the transplant evaluation visit , the unit of analysis will be the individual potential transplant candidate .
CONCLUSIONS	The ELITE Study will help to determine how education in a transplant center can best be designed to help Black and non-Black patients learn about the option of LDKT .
BACKGROUND	Clinicaltrials.gov number NCT01261910 .

###25692789
BACKGROUND	Controversy exists about whether cutting diathermy for skin incisions leads to a cosmetically inferior scar .
BACKGROUND	Cosmetic outcomes were compared between skin incisions created with cutting diathermy versus scalpel .
BACKGROUND	Wound infection rates and postoperative incisional pain were also compared .
METHODS	This was a randomized double-blind trial comparing cutting diathermy and scalpel in patients undergoing bowel resection .
METHODS	Scar cosmesis was assessed at 6 months after surgery by a plastic surgeon and a research associate using the Vancouver Scar Scale ( VSS ) and the Patient and Observer Scar Assessment Scale ( POSAS ) .
METHODS	Patients also used POSAS to self-evaluate their scars .
METHODS	Wound infections within 30 days were recorded , and incision pain scores were measured on the first 5 days after operation .
RESULTS	A total of 66 patients were randomized to cutting diathermy ( 31 ) or scalpel ( 35 ) .
RESULTS	At 6 months , there was no significant difference between the diathermy and scalpel groups in mean ( s.d. ) VSS scores ( 49 ( 26 ) versus 50 ( 19 ) ; P = 0837 ) , mean POSAS total scores ( 192 ( 80 ) versus 200 ( 74 ) ; P = 0684 ) or subjective POSAS total scores ( 202 ( 121 ) versus 213 ( 104 ) ; P = 0725 ) .
RESULTS	Neither were there significant differences in wound infection rates between the groups ( 5 of 30 versus 5 of 32 ; P = 1000 ) .
RESULTS	Pain scores on day 1 after operation were significantly lower in the diathermy group ( mean 168 versus 313 ; P = 0018 ) , but were not significantly different on days 2-5 .
CONCLUSIONS	Cutting diathermy is a cosmetically acceptable technique for abdominal skin incisions .
CONCLUSIONS	There is no increased risk of wound infection , and diathermy may convey benefit in terms of early postoperative wound pain .
BACKGROUND	NCT01496404 ( http://www.clinicaltrials.gov ) .

###25033150
OBJECTIVE	We evaluated the effect of a weight gain prevention intervention ( Shape Program ) on depression among socioeconomically disadvantaged overweight and obese Black women .
METHODS	Between 2009 and 2012 , we conducted a randomized trial comparing a 12-month electronic health-based weight gain prevention intervention to usual primary care at 5 central North Carolina community health centers .
METHODS	We assessed depression with the Patient Health Questionnaire ( PHQ-8 ) .
METHODS	We analyzed change in depression score from baseline to 12 - and 18-month follow-up across groups with mixed models .
METHODS	We used generalized estimating equation models to analyze group differences in the proportion above the clinical threshold for depression ( PHQ-8 score 10 ) .
RESULTS	At baseline , 20 % of participants reported depression .
RESULTS	Twelve-month change in depression scores was larger for intervention participants ( mean difference = -1.85 ; 95 % confidence interval = -3.08 , -0.61 ; P = .004 ) .
RESULTS	There was a significant reduction in the proportion of intervention participants with depression at 12 months with no change in the usual-care group ( 11 % vs 19 % ; P = .035 ) .
RESULTS	All effects persisted after we controlled for weight change and medication use .
RESULTS	We saw similar findings at 18 months .
CONCLUSIONS	The Shape Program , which includes no mention of mood , improved depression among socioeconomically disadvantaged Black women .

###24447190
OBJECTIVE	To evaluate whether trait and experimentally manipulated state disgust independently and/or interactively predict immediate and anticipated avoidance in decision scenarios related to colorectal cancer ( CRC ) .
METHODS	Eighty participants , aged 18 to 66 years , completed questionnaires assessing trait disgust prior to a laboratory session .
METHODS	Participants were gender block randomized to disgust or control conditions before completing tasks assessing immediate avoidance of a CRC disgust elicitor ( stoma bag ) and anticipated avoidance in hypothetical CRC scenarios .
RESULTS	Manipulation checks confirmed the elicitation of disgust in the experimental condition .
RESULTS	Persons in the experimental condition were more likely to exhibit immediate avoidance behaviors in response to a commonly used bowel disease device ( stoma bag ) , and trait disgust predicted time to touch the device .
RESULTS	Trait disgust also moderated the influence of state disgust on anticipated avoidance , namely delay in help seeking for bowel symptoms and predicted rating disgusting side effects as more deterring to adherence .
CONCLUSIONS	The current report suggests the importance of examining disgust in CRC contexts and provides the first empirical demonstration that state and trait aspects of disgust may interactively operate to deter certain types of decisions .
CONCLUSIONS	It thus furthers understanding of emotions and avoidance in a health context that has had surprisingly little focus to date .

###24720702
BACKGROUND	High rates of sustained virologic response were observed among patients with hepatitis C virus ( HCV ) infection who received 12 weeks of treatment with the nucleotide polymerase inhibitor sofosbuvir combined with the NS5A inhibitor ledipasvir .
BACKGROUND	This study examined 8 weeks of treatment with this regimen .
METHODS	In this phase 3 , open-label study , we randomly assigned 647 previously untreated patients with HCV genotype 1 infection without cirrhosis to receive ledipasvir and sofosbuvir ( ledipasvir-sofosbuvir ) for 8 weeks , ledipasvir-sofosbuvir plus ribavirin for 8 weeks , or ledipasvir-sofosbuvir for 12 weeks .
METHODS	The primary end point was sustained virologic response at 12 weeks after the end of therapy .
RESULTS	The rate of sustained virologic response was 94 % ( 95 % confidence interval [ CI ] , 90 to 97 ) with 8 weeks of ledipasvir-sofosbuvir , 93 % ( 95 % CI , 89 to 96 ) with 8 weeks of ledipasvir-sofosbuvir plus ribavirin , and 95 % ( 95 % CI , 92 to 98 ) with 12 weeks of ledipasvir-sofosbuvir .
RESULTS	As compared with the rate of sustained virologic response in the group that received 8 weeks of ledipasvir-sofosbuvir , the rate in the 12-week group was 1 percentage point higher ( 97.5 % CI , -4 to 6 ) and the rate in the group that received 8 weeks of ledipasvir-sofosbuvir with ribavirin was 1 percentage point lower ( 95 % CI , -6 to 4 ) ; these results indicated noninferiority of the 8-week ledipasvir-sofosbuvir regimen , on the basis of a noninferiority margin of 12 percentage points .
RESULTS	Adverse events were more common in the group that received ribavirin than in the other two groups .
RESULTS	No patient who received 8 weeks of only ledipasvir-sofosbuvir discontinued treatment owing to adverse events .
CONCLUSIONS	Ledipasvir-sofosbuvir for 8 weeks was associated with a high rate of sustained virologic response among previously untreated patients with HCV genotype 1 infection without cirrhosis .
CONCLUSIONS	No additional benefit was associated with the inclusion of ribavirin in the regimen or with extension of the duration of treatment to 12 weeks .
CONCLUSIONS	( Funded by Gilead Sciences ; ION-3 ClinicalTrials.gov number , NCT01851330 . )

###25467221
OBJECTIVE	Investigate the efficacy of nabilone capsules ( NAB ) in reducing the frequency and intensity of nightmares in subjects with PTSD .
METHODS	Canadian male military personnel with PTSD , who despite standard treatment continued to experience trauma-related nightmares , received double-blind treatment with 0.5 mg NAB or placebo ( PBO ) , and then titrated to the effective dose ( nightmare suppression ) or reaching a maximum of 3.0 mg .
METHODS	Subjects were followed for 7 weeks and then , following a 2-week washout period , were titrated with the other study treatment and followed for an additional 7 weeks .
METHODS	The modified intent-to-treat ( mITT ) population , which included all treated subjects that met inclusion/exclusion criteria , was analyzed .
RESULTS	Ten subjects were included in the mITT population .
RESULTS	The mean reduction in nightmares as measured by the CAPS Recurring and Distressing Dream scores were -3.6 2.4 and -1.0 2.1 in the NAB and PBO groups , respectively ( p = 0.03 ) .
RESULTS	Mean global improvement as measured by the Clinical Global Impression of Change ( CGI-C ) was 1.9 1.1 ( i.e. much improved ) and 3.2 1.2 ( i.e. minimally improved ) in the NAB and PBO groups , respectively ( p = 0.05 ) Five out of 10 ( 50 % ) were much improved on NAB versus 1 out of 9 ( 11 % ) on PBO .
RESULTS	Results for the General Well Being Questionnaire ( WBQ ) were 20.8 22 and -0.4 20.6 in the NAB and PBO groups , respectively ( p = 0.04 ) .
RESULTS	The proportion of subjects who experienced a treatment-related occurrence of adverse events was 50 % in the NBO group and 60 % in the PBO group .
RESULTS	No event was severe nor resulted in a drop-out .
RESULTS	This study is registered with Health Canada .
CONCLUSIONS	In this small sample NAB provided significant relief for military personnel with PTSD , indicating that it shows promise as a clinically-relevant treatment for patients with nightmares and a history of non-response to traditional therapies .
CONCLUSIONS	These findings need to be replicated in a larger cohort .
CONCLUSIONS	There is a need for further exploration of the effect of nabilone on other symptoms of PTSD such as re-experiencing , hyper vigilance and insomnia .

###25260489
OBJECTIVE	Patients with bone metastases have a widely varying survival .
OBJECTIVE	A reliable estimation of survival is needed for appropriate treatment strategies .
OBJECTIVE	Our goal was to assess the value of simple prognostic factors , namely , patient and tumor characteristics , Karnofsky performance status ( KPS ) , and patient-reported scores of pain and quality of life , to predict survival in patients with painful bone metastases .
METHODS	In the Dutch Bone Metastasis Study , 1157 patients were treated with radiation therapy for painful bone metastases .
METHODS	At randomization , physicians determined the KPS ; patients rated general health on a visual analogue scale ( VAS-gh ) , valuation of life on a verbal rating scale ( VRS-vl ) and pain intensity .
METHODS	To assess the predictive value of the variables , we used multivariate Cox proportional hazard analyses and C-statistics for discriminative value .
METHODS	Of the final model , calibration was assessed .
METHODS	External validation was performed on a dataset of 934 patients who were treated with radiation therapy for vertebral metastases .
RESULTS	Patients had mainly breast ( 39 % ) , prostate ( 23 % ) , or lung cancer ( 25 % ) .
RESULTS	After a maximum of 142 weeks ' follow-up , 74 % of patients had died .
RESULTS	The best predictive model included sex , primary tumor , visceral metastases , KPS , VAS-gh , and VRS-vl ( C-statistic = 0.72 , 95 % CI = 0.70-0 .74 ) .
RESULTS	A reduced model , with only KPS and primary tumor , showed comparable discriminative capacity ( C-statistic = 0.71 , 95 % CI = 0.69-0 .72 ) .
RESULTS	External validation showed a C-statistic of 0.72 ( 95 % CI = 0.70-0 .73 ) .
RESULTS	Calibration of the derivation and the validation dataset showed underestimation of survival .
CONCLUSIONS	In predicting survival in patients with painful bone metastases , KPS combined with primary tumor was comparable to a more complex model .
CONCLUSIONS	Considering the amount of variables in complex models and the additional burden on patients , the simple model is preferred for daily use .
CONCLUSIONS	In addition , a risk table for survival is provided .

###25456116
BACKGROUND	Surgical stress may cause immunosuppression especially in patients who have surgery for primary tumor removed .
BACKGROUND	This study aimed to explore the effects of dexmedetomidine on immune and inflammatory response in patients undergoing radical gastrectomy .
METHODS	After the institutional review board approval and written informed consent , forty patients undergoing radical gastrectomy were equally randomized to receive dexmedetomidine infusion ( Dex group ; 0.5 g kg ( -1 ) initial dose followed by a maintenance dose of 0.4 g kg ( -1 ) h ( -1 ) ) or normal saline infusion ( NS group ) .
METHODS	Helper T lymphocytes ( T helper 1 [ Th1 ] and T helper 2 [ Th2 ] ) , tumor necrosis factor - , and interleukin-6 were measured during and after surgeries .
METHODS	Plasma catecholamine levels were also measured during surgery .
METHODS	Postoperative pain was measured by a visual analog scale .
RESULTS	The percentage of Th1 increased significantly at the end of surgery , 24 h after surgery ( P = 0.045 and 0.048 , respectively ) , and Th2 decreased notably at the end of surgery in the Dex group ( P = 0.030 ) .
RESULTS	Plasma levels of tumor necrosis factor - ( P = 0.045 and 0.036 , respectively ) and interleukin-6 ( P = 0.049 and 0.042 , respectively ) differed significantly at the end of surgery and 24 h after surgery .
RESULTS	Plasma epinephrine and norepinephrine levels decreased significantly at the beginning of surgery in the Dex group ( P = 0.020 and 0.015 , respectively ) .
RESULTS	At the end of surgery , plasma dopamine levels decreased significantly in the Dex group ( P = 0.048 ) , but increased in the NS group .
RESULTS	The visual analog scale pain score was lower in the Dex group than in the NS group 24 h after surgery ( P = 0.046 ) .
CONCLUSIONS	Dexmedetomidine has been shown to reduce surgical stresses and maintain Th1/Th2 balance .
CONCLUSIONS	It has been shown to reduce inflammatory responses and exerts immunoprotective effect .

###25884190
BACKGROUND	Although parental support is an important component in overweight prevention programs for children , current programs pay remarkably little attention to the role of parenting .
BACKGROUND	To close this gap , we developed a web-based parenting program for parents entitled `` Making a healthy deal with your child '' .
BACKGROUND	This e-learning program can be incorporated into existing prevention programs , thereby improving these interventions by reinforcing the role of parenting and providing parents with practical tools for use in everyday situations in order to stimulate a healthy lifestyle .
BACKGROUND	Here , we report the research design of a study to determine the effectiveness of our e-learning program .
METHODS	The effectiveness of an e-learning program was studied in a two-armed cluster randomized controlled trial .
METHODS	Parents of children 9-13 years of age who live in the Nijmegen region , the Netherlands , and who participated in the existing school-based overweight prevention program `` Scoring for Health '' were invited to participate in this study .
METHODS	Our goal was to recruit 322 parent-child dyads .
METHODS	At the school grade level , parents were randomly assigned to either the intervention group ( which received e-learning and a brochure ) or the control group ( which received only the brochure ) ; the participants were stratified by ethnicity .
METHODS	Measurements were taken from both the parents and the children at baseline , and then 5 and 12months after baseline .
METHODS	Primary outcomes included the child 's dietary and sedentary behavior , and level of physical activity .
METHODS	Secondary outcomes included general parenting style , specific parenting practices ( e.g. , set of rules , modeling , and monitoring ) , and parental self-efficacy .
CONCLUSIONS	We hypothesize that children of parents who follow the e-learning program will have a healthier diet , will be less sedentary , and will have a higher level of physical activity compared to the children in the control group .
CONCLUSIONS	If the e-learning program is found to be effective , it can be incorporated into existing overweight prevention programs for children ( e.g. , `` Scoring for Health '' ) , as well as activities regarding Youth Health Care .
BACKGROUND	Dutch Trial Register : NTR3938 .
BACKGROUND	Date of registration : April 7 ( th ) , 2013 .

###25622303
OBJECTIVE	Severe neglect in early life is associated with compromises in brain development and associated behavioral functioning .
OBJECTIVE	Although early intervention has been shown to support more normative trajectories of brain development , specific improvements in the white matter pathways that underlie emotional and cognitive development are unknown .
OBJECTIVE	To examine associations among neglect in early life , early intervention , and the microstructural integrity of white matter pathways in middle childhood .
METHODS	The Bucharest Early Intervention Project is a randomized clinical trial of high-quality foster care as an intervention for institutionally reared children in Bucharest , Romania , from 2000 through the present .
METHODS	During infancy , children were randomly selected to remain in an institution or to be placed in foster care .
METHODS	Those who remained in institutions experienced neglect , including social , emotional , linguistic , and cognitive impoverishment .
METHODS	Developmental trajectories of these children were compared with a group of sociodemographically matched children reared in biological families at baseline and several points throughout development .
METHODS	At approximately 8 years of age , 69 of the original 136 children underwent structural magnetic resonance imaging scans .
METHODS	Four estimates of white matter integrity ( fractional anisotropy [ FA ] and mean [ MD ] , radial [ RD ] , and axial [ AD ] diffusivity ) for 48 white matter tracts throughout the brain were obtained through diffusion tensor imaging .
RESULTS	Significant associations emerged between neglect in early life and microstructural integrity of the body of the corpus callosum ( FA , = 0.01 [ P = .01 ] ; RD , = -0.02 [ P = .005 ] ; MD , = -0.01 [ P = .02 ] ) and tracts involved in limbic circuitry ( fornix crus [ AD , = 0.02 ( P = .046 ) ] and cingulum [ RD , = -0.01 ( P = .02 ) ; MD , = -0.01 ( P = .049 ) ] ) , frontostriatal circuitry ( anterior [ AD , = -0.01 ( P = .02 ) ] and superior [ AD , = -0.02 ( P = .02 ) ; MD , = -0.01 ( P = .03 ) ] corona radiata and external capsule [ right FA , = 0.01 ( P = .03 ) ; left FA , = 0.01 ( P = .03 ) ; RD , = -0.01 ( P = .01 ) ; MD , = -0.01 ( P = .03 ) ] ) , and sensory processing ( medial lemniscus [ AD , = -0.02 ( P = .045 ) ; MD , = -0.01 ( P = .04 ) ] and retrolenticular internal capsule [ FA , = -0.01 ( P = .002 ) ; RD , = 0.01 ( P = .003 ) ; MD , = 0.01 ( P = .04 ) ] ) .
RESULTS	Follow-up analyses revealed that early intervention promoted more normative white matter development among previously neglected children who entered foster care .
CONCLUSIONS	Results suggest that removal from conditions of neglect in early life and entry into a high-quality family environment can support more normative trajectories of white matter growth .
CONCLUSIONS	Our findings have implications for public health and policy efforts designed to promote normative brain development among vulnerable children .
BACKGROUND	clinicaltrials.gov Identifier : NCT00747396 .

###24238512
BACKGROUND	Famitinib is a novel and potent multitargeting receptor tyrosine kinase inhibitor .
BACKGROUND	The phase I clinical study showed that famitinib was well tolerated and had a broad anti-tumor spectrum .
BACKGROUND	The purpose of this study was to examine the efficacy and safety of famitinib for the treatment of metastatic renal cell carcinoma ( mRCC ) .
METHODS	The data of famitinib in treating patients with mRCC from the single-center phases I and II clinical trials were analyzed .
METHODS	Famitinib was administered orally at the dose of 13-30 mg once daily until tumor progression , occurrence of intolerable adverse reactions or withdrawal of the informed consent .
RESULTS	A total of 24 patients with mRCC were treated including 17 patients at a dose of 25 mg once daily , 4 patients at a dose of 27 mg and 1 patient each at a dose of 13 mg , 20 mg and 30 mg , respectively .
RESULTS	Twelve ( 50.0 % ) patients achieved partial response ( PR ) and 9 patients achieved stable disease ( SD ) .
RESULTS	Progressive disease was found in 3 ( 12.5 % ) patients .
RESULTS	The disease control rate was 87.5 % .
RESULTS	The median follow-up time was 17.6 months ; the median progression free survival ( PFS ) was 10.7 ( 95 % CI 7.0-14 .4 ) months ; and the estimated median overall survival ( OS ) time was 33.0 ( 95 % CI 8.7-57 .3 ) months .
RESULTS	The adverse drug reactions mainly included hypertension ( 54.1 % ) , hand-foot skin reactions ( 45.8 % ) , diarrhea ( 33.3 % ) , mucositis ( 29.2 % ) , neutropenia ( 45.8 % ) , thrombocytopenia ( 29.2 % ) , hyperlipidemia ( 41.7 % ) and proteinuria ( 41.7 % ) .
RESULTS	The incidence rate of grades 3 and 4 adverse events was low , mainly including hypertension 12.5 % , hand-foot skin reactions 4.2 % , neutropenia 4.2 % , thrombocytopenia 4.2 % , hyperlipidemia 4.2 % and proteinuria 12.5 % .
CONCLUSIONS	Famitinib has significant anti-tumor activity in mRCC .
CONCLUSIONS	The common adverse reactions are generally manageable .

###25204098
OBJECTIVE	The aim of this research was to assess the delayed effects of a two-year alcohol prevention program implemented in Polish primary schools .
METHODS	The program comprised two curricula implemented the school and in family houses : Program Domowych Detektyww and Fantastyczne Mozliwoci .
METHODS	Both curricula were the Polish versions of two American school-based prevention programs which belonged to Project Northland .
METHODS	The initial study sample ( N = 802 ) comprised 10 to 11 years old pupils ( fourth and fifth-grade ) from eight primary schools in Warsaw .
METHODS	Schools were randomly assigned to the intervention ( n = 421 ) and the reference group ( n = 381 ) .
METHODS	A self-completion questionnaire was administered to students four times : at the baseline , seven , fifteen and twenty seven months after .
RESULTS	The program had an expected influence on the students ' attitudes , knowledge and resistance skills towards alcohol .
RESULTS	The effects on the participants ' initiation of drunkenness and their first experience in alcohol use with their peers have also been reported .
RESULTS	Most of the positive effects remained significant over time .
CONCLUSIONS	The effectiveness of the program , as shown by the outcome evaluation , supports an argument for its wide implementation in Polish schools .
CONCLUSIONS	Further progress in the field of alcohol and drug prevention in Poland depends on overcoming the existing barriers in this area of public health .

###24722494
OBJECTIVE	To investigate the efficacy and tolerability of empagliflozin as an add-on to metformin therapy in patients with type 2 diabetes .
METHODS	Patients with HbA1c levels of 7 % to 10 % ( 53 to 86 mmol/mol ) while receiving metformin ( 1,500 mg/day ) were randomized and treated with once-daily treatment with empagliflozin 10 mg ( n = 217 ) , empagliflozin 25 mg ( n = 213 ) , or placebo ( n = 207 ) for 24 weeks .
METHODS	The primary end point was the change in HbA1c level from baseline at week 24 .
METHODS	Key secondary end points were changes from baseline in weight and mean daily glucose ( MDG ) at week 24 .
RESULTS	At week 24 , adjusted mean ( SE ) changes from baseline in HbA1c were -0.13 % ( 0.05 ) % ( -1.4 [ 0.5 ] mmol/mol ) with placebo , -0.70 % ( 0.05 ) % ( -7.7 [ 0.5 ] mmol/mol ) with empagliflozin 10 mg , and -0.77 % ( 0.05 ) % ( -8.4 [ 0.5 ] mmol/mol ) with empagliflozin 25 mg ( both P < 0.001 ) .
RESULTS	Empagliflozin significantly reduced MDG level and systolic and diastolic blood pressure ( BP ) versus placebo .
RESULTS	Adjusted mean ( SE ) changes from baseline in weight were -0.45 kg ( 0.17 kg ) with placebo , -2.08 kg ( 0.17 kg ) with empagliflozin 10 mg , and -2.46 kg ( 0.17 kg ) with empagliflozin 25 mg ( both P < 0.001 ) .
RESULTS	Adverse events ( AEs ) were similar across groups ( placebo 58.7 % ; empagliflozin 49.5-57 .1 % ) .
RESULTS	Confirmed hypoglycemic AEs were reported in 0.5 % , 1.8 % , and 1.4 % of patients receiving placebo , empagliflozin 10 mg , and empagliflozin 25 mg , respectively .
RESULTS	Events consistent with urinary tract infections were reported in 4.9 % , 5.1 % , and 5.6 % of patients , and events consistent with genital infections were reported in 0 % , 3.7 % , and 4.7 % of patients , respectively .
CONCLUSIONS	Empagliflozin 10 and 25 mg for 24 weeks as add-on to metformin therapy significantly improved glycemic control , weight , and BP , and were well-tolerated .

###24355343
OBJECTIVE	Centre-based childcare services represent a promising setting to target the prevention of excessive weight gain in preschool-aged children .
OBJECTIVE	Staff training is a key component of multi-strategy interventions to improve implementation of effective physical activity and nutrition promoting practices for obesity prevention in childcare services .
OBJECTIVE	This randomised controlled trial aimed to examine whether an active telephone-based strategy to invite childcare-service staff to attend a training workshop was effective in increasing the proportion of services with staff attending training , compared with a passive strategy .
METHODS	Services were randomised to an active telephone-based or a passive-recruitment strategy .
METHODS	Those in the active arm received an email invitation and one to three follow-up phone calls , whereas services in the passive arm were informed of the availability of training only via newsletters .
METHODS	The proportion of services with staff attending the training workshop was compared between the two arms .
RESULTS	One hundred and twenty-eight services were included in this study .
RESULTS	A significantly larger proportion ( 52 % ) of services in the active arm compared with those in the passive-strategy arm ( 3.1 % ) attended training ( d.f. = 1 , 2 = 34.3 ; P < 0.001 ) .
CONCLUSIONS	An active , telephone-based recruitment strategy significantly increased the proportion of childcare services with staff attending training .
CONCLUSIONS	Further strategies to improve staff attendance at training need to be identified and implemented .
CONCLUSIONS	SO WHAT ?
CONCLUSIONS	: Active-recruitment strategies including follow-up telephone calls should be utilised to invite staff to participate in training , in order to maximise the use of training as an implementation strategy for obesity prevention in childcare services .

###25170594
BACKGROUND	An aluminum hydroxide-adsorbed depot allergoid preparation of six-grass pollen allergens has been developed for short-term preseasonal immunotherapy in pollinosis .
BACKGROUND	However , only limited knowledge exists about its immunological and clinical effects .
BACKGROUND	The aim of this study was to evaluate the basophil response , which can explain early clinical findings of short-term preseasonal allergoid immunotherapy in allergic rhinitis .
METHODS	In a double-blind , placebo-controlled study , 31 patients allergic to grass pollens received one course of short-term preseasonal allergoid immunotherapy or placebo .
METHODS	Immunogenicity was assessed by the levels of specific IgG4 , IgE antibodies and an allergen-induced CD203c basophil activation test .
METHODS	The primary clinical end point was the combined symptom and medication score/average combined score ( ACS ) .
RESULTS	There was a 52.9 % difference in ACS between the treatment and placebo groups in favor of immunotherapy ( p = 0.01 ) .
RESULTS	Active treatment induced Phleum pratense-specific IgG4 and IgE antibodies ( p < 0.05 ) .
RESULTS	A decrease in allergen-induced basophil activation at submaximal allergen concentrations was demonstrated at the end of immunotherapy and at the peak of the grass pollen season after immunotherapy .
CONCLUSIONS	This study shows that grass pollen-allergic patients treated with one course of short-term preseasonal allergoid immunotherapy exhibit a decrease in allergen-induced basophil activation , an increase in allergen-specific IgG4 antibodies and early clinical improvement .

###25561577
OBJECTIVE	To examine the effects of a whole-body cryotherapy ( WBC ) protocol ( 3 min at -110 C ) on acute recovery and key variables of endurance performance during high-intensity intermittent exercise in a thermoneutral environment .
METHODS	Eleven endurance athletes were tested twice in a randomized crossover design in which 55 min of high-intensity running ( HIR ) were followed by 1 h of passive rest at ~ 22C , including either 3 min of whole-body exposure to -110 C ( WBC ) or a placebo intervention of 3 min walking ( PBO ) .
METHODS	A ramp-test protocol was performed before HIR ( R1 ) and after the 1-h recovery period ( R2 ) .
METHODS	Time to exhaustion ( tlim ) was measured along with alterations in oxygen content of the vastus lateralis ( TSI ) , oxygen consumption ( VO2 ) , capillary blood lactate , heart rate ( HR ) , and rating of perceived exertion ( RPE ) during submaximal and maximal running .
RESULTS	The difference in tlim between R1 and R2 was lower in WBC than in PBO ( P < .05 , effect size d = 1.13 ) .
RESULTS	During R2 , TSI was higher in WBC during submaximal and maximal running ( P < .01 , d = 0.68-1 .01 ) .
RESULTS	In addition , VO2 , HR , and RPE were lower at submaximal level of R2 after WBC than in PBO ( P = .04 to < .01 , d = 0.23-0 .83 ) .
CONCLUSIONS	WBC improves acute recovery during high-intensity intermittent exercise in thermoneutral conditions .
CONCLUSIONS	The improvements might be induced by enhanced oxygenation of the working muscles , as well as a reduction in cardiovascular strain and increased work economy at submaximal intensities .

###25527767
BACKGROUND	Previously , a healthy Nordic diet ( ND ) has been shown to have beneficial health effects close to those of Mediterranean diets .
OBJECTIVE	The objective was to explore whether the ND has an impact on gene expression in abdominal subcutaneous adipose tissue ( SAT ) and whether changes in gene expression are associated with clinical and biochemical effects .
METHODS	Obese adults with features of the metabolic syndrome underwent an 18 - to 24-wk randomized intervention study comparing the ND with the control diet ( CD ) ( the SYSDIET study , carried out within Nordic Centre of Excellence of the Systems Biology in Controlled Dietary Interventions and Cohort Studies ) .
METHODS	The present study included participants from 3 Nordic SYSDIET centers [ Kuopio ( n = 20 ) , Lund ( n = 18 ) , and Oulu ( n = 18 ) ] with a maximum weight change of 4 kg , highly sensitive C-reactive protein concentration < 10 mg/L at the beginning and the end of the intervention , and baseline body mass index ( in kg/m ) < 38 .
METHODS	SAT biopsy specimens were obtained before and after the intervention and subjected to global transcriptome analysis with Gene 1.1 ST Arrays ( Affymetrix ) .
RESULTS	Altogether , 128 genes were differentially expressed in SAT between the ND and CD ( nominal P < 0.01 ; false discovery rate , 25 % ) .
RESULTS	These genes were overrepresented in pathways related to immune response ( adjusted P = 0.0076 ) , resulting mainly from slightly decreased expression in the ND and increased expression in the CD .
RESULTS	Immune-related pathways included leukocyte trafficking and macrophage recruitment ( e.g. , interferon regulatory factor 1 , CD97 ) , adaptive immune response ( interleukin32 , interleukin 6 receptor ) , and reactive oxygen species ( neutrophil cytosolic factor 1 ) .
RESULTS	Interestingly , the regulatory region of the 128 genes was overrepresented for binding sites for the nuclear transcription factor B.
CONCLUSIONS	A healthy Nordic diet reduces inflammatory gene expression in SAT compared with a control diet independently of body weight change in individuals with features of the metabolic syndrome .

###25461825
OBJECTIVE	To investigate the effects of anodal transcranial direct current stimulation ( a-tDCS ) intensity on corticospinal excitability and affected muscle activation in individuals with chronic spinal cord injury ( SCI ) .
METHODS	Single-blind , randomized , sham-controlled , crossover study .
METHODS	Medical research institute and rehabilitation hospital .
METHODS	Volunteers ( N = 9 ) with chronic SCI and motor dysfunction in wrist extensor muscles .
METHODS	Three single session exposures to 20 minutes of a-tDCS ( anode over the extensor carpi radialis [ ECR ] muscle representation on the left primary motor cortex , cathode over the right supraorbital area ) using 1 mA , 2 mA , or sham stimulation , delivered at rest , with at least 1 week between sessions .
METHODS	Corticospinal excitability was assessed with motor-evoked potentials ( MEPs ) from the ECR muscle using surface electromyography after transcranial magnetic stimulation .
METHODS	Changes in spinal excitability , sensory threshold , and muscle strength were also investigated .
RESULTS	Mean MEP amplitude significantly increased by approximately 40 % immediately after 2mA a-tDCS ( pre : 0.36 0.1 mV ; post : 0.47 0.11 mV ; P = .001 ) , but not with 1 mA or sham .
RESULTS	Maximal voluntary contraction measures remained unaltered across all conditions .
RESULTS	Sensory threshold significantly decreased over time after 1mA ( P = .002 ) and 2mA ( P = .039 ) a-tDCS and did not change with sham .
RESULTS	F-wave persistence showed a nonsignificant trend for increase ( pre : 32 % 12 % ; post : 41 % 10 % ; follow-up : 46 % 12 % ) after 2 mA stimulation .
RESULTS	No adverse effects were reported with any of the experimental conditions .
CONCLUSIONS	The a-tDCS can transiently raise corticospinal excitability to affected muscles in patients with chronic SCI after 2 mA stimulation .
CONCLUSIONS	Sensory perception can improve with both 1 and 2 mA stimulation .
CONCLUSIONS	This study gives support to the safe and effective use of a-tDCS using small electrodes in patients with SCI and highlights the importance of stimulation intensity .

###24715213
BACKGROUND	The feasibility and safety of D2 surgery following neoadjuvant chemotherapy ( NAC ) has not been fully evaluated in patients with gastric cancer .
BACKGROUND	Moreover , risk factor for surgical complications after D2 gastrectomy following NAC is also unknown .
BACKGROUND	The purpose of the present study was to identify risk factors of postoperative complications after D2 surgery following NAC .
METHODS	This study was conducted as an exploratory analysis of a prospective , randomized Phase II trial of NAC .
METHODS	The surgical complications were assessed and classified according to the Clavien-Dindo classification .
METHODS	A uni - and multivariate logistic regression analyses were performed to identify risk factors for morbidity .
RESULTS	Among 83 patients who were registered to the Phase II trial , 69 patients received the NAC and D2 gastrectomy .
RESULTS	Postoperative complications were identified in 18 patients and the overall morbidity rate was 26.1 % .
RESULTS	The results of univariate and multivariate analyses of various factors for overall operative morbidity , creatinine clearance ( CCr ) 60 ml/min ( P = 0.016 ) was identified as sole significant independent risk factor for overall morbidity .
RESULTS	Occurrence of pancreatic fistula was significantly higher in the patients with a low CCr than in those with a high CCr .
CONCLUSIONS	Low CCr was a significant risk factor for surgical complications in D2 gastrectomy after NAC .
CONCLUSIONS	Careful attention is required for these patients .

###25799024
BACKGROUND	In recent years , armed conflicts in the Middle East have resulted in high rates of exposure to traumatic events .
BACKGROUND	Despite the increasing demand of mental health care provision , ongoing violence limits conventional approaches of mental health care provision .
BACKGROUND	Internet-based interventions for posttraumatic stress disorder ( PTSD ) have proved feasible and effective in Western countries , but their applicability and efficacy in war and conflict regions remains unknown .
OBJECTIVE	This study investigated the efficacy of a cognitive behavioral Internet-based intervention for war-traumatized Arab patients , with focus on Iraq .
METHODS	A total of 159 individuals with PTSD participated in a parallel group randomized trial .
METHODS	Participants were randomly allocated by a computer-generated sequence to a treatment group ( n = 79 ) or a waiting list control group ( n = 80 ) .
METHODS	The treatment group received 2 weekly 45-minute cognitive behavioral interventions via Internet over a 5-week period ( 10 sessions in total ) .
METHODS	The primary outcome was recovery from posttraumatic stress symptoms .
RESULTS	Posttraumatic stress symptoms were significantly reduced from baseline to posttreatment ( intention-to-treat analysis ) in the treatment group relative to the control group ( F1 ,157 = 44.29 , P < .001 , d = 0.92 ) .
RESULTS	Treatment effects were sustained at 3-month follow-up .
RESULTS	Completer analysis indicated that 29 of 47 patients ( 62 % ) in the treatment group had recovered from posttraumatic stress symptoms at posttreatment ( reliable change and Posttraumatic Stress Diagnostic Scale score < 20 ) versus 1 patient ( 2 % ) in the control group ( OR 74.19 , 95 % CI 9.93-585 .8 , P < .001 ) indicating that the chance of recovering was 74.19 times higher in the treatment than in the control group .
CONCLUSIONS	The results indicate , even in unstable and insecure settings with ongoing exposure to human rights violations through war and dictatorships , people with posttraumatic stress symptoms benefit from a cognitive behavioral treatment provided entirely through the Internet .
CONCLUSIONS	This method of delivery could improve patients ' access to humanitarian aid in the form of e-mental health services .
BACKGROUND	Australian New Zealand Clinical Trial Registry , ACTRN12611001019998 ; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=347505 ( Archived by WebCite at http://www.webcitation.org/6Wto4HCdH ) .

###25280421
OBJECTIVE	To our knowledge , no randomized study has shown whether zinc replacement therapy is effective for hyperammonemia in liver cirrhosis ; therefore , we performed a double-blind , placebo-controlled trial to examine efficacy and safety of the zinc replacement therapy .
METHODS	Patients with liver cirrhosis and hyperammonemia ( at or above the institutional reference value ) and hypozincemia ( 65 g/dL ) were enrolled in the outpatient units of the participating institutions and were randomly divided to receive placebo ( P group ) or zinc acetate preparation at a dose of 3 capsules/d for a total zinc content of 150 mg/d ( Z group ) by the envelope method .
METHODS	Of the 18 enrolled patients , 6 dropped out ; thus , the analyses included 12 patients ( 5 in the P group and 7 in the Z group ) .
METHODS	Variations in blood concentrations of zinc and ammonia as well as liver function test results were compared .
RESULTS	Blood zinc levels significantly increased in the Z group ( P = 0.0037 ; Friedman test ) but not the P group .
RESULTS	Blood ammonia levels significantly decreased in the Z group ( P = 0.0114 ; Friedman test ) but not the P group .
RESULTS	The percent change in blood ammonia level also revealed significant reduction at the eighth week in the Z group ( P = 0.0188 : Mann-Whitney test ) .
RESULTS	No serious adverse events attributable to the zinc preparation were noted .
CONCLUSIONS	Although this study is preliminary and includes a small sample , it is , to our knowledge , the first randomized controlled trial to show that zinc supplementation for 3 mo seems effective and safe for treating hyperammonemia in liver cirrhosis .
CONCLUSIONS	Studies with a larger sample size are needed to confirm our findings .

###24471739
OBJECTIVE	The relative efficiency of different eye exercise regimes is unclear , and in particular the influences of practice , placebo and the amount of effort required are rarely considered .
OBJECTIVE	This study measured conventional clinical measures following different regimes in typical young adults .
METHODS	A total of 156 asymptomatic young adults were directed to carry out eye exercises three times daily for 2 weeks .
METHODS	Exercises were directed at improving blur responses ( accommodation ) , disparity responses ( convergence ) , both in a naturalistic relationship , convergence in excess of accommodation , accommodation in excess of convergence , and a placebo regime .
METHODS	They were compared to two control groups , neither of which were given exercises , but the second of which were asked to make maximum effort during the second testing .
RESULTS	Instruction set and participant effort were more effective than many exercises .
RESULTS	Convergence exercises independent of accommodation were the most effective treatment , followed by accommodation exercises , and both regimes resulted in changes in both vergence and accommodation test responses .
RESULTS	Exercises targeting convergence and accommodation working together were less effective than those where they were separated .
RESULTS	Accommodation measures were prone to large instruction/effort effects and monocular accommodation facility was subject to large practice effects .
CONCLUSIONS	Separating convergence and accommodation exercises seemed more effective than exercising both systems concurrently and suggests that stimulation of accommodation and convergence may act in an additive fashion to aid responses .
CONCLUSIONS	Instruction/effort effects are large and should be carefully controlled if claims for the efficacy of any exercise regime are to be made .

###24632673
BACKGROUND	Pulmonary coagulopathy may play a pathogenetic role in acute respiratory distress syndrome ( ARDS ) , by contributing to alveolocapillary inflammation and increased permeability .
BACKGROUND	Recombinant human activated protein C ( rh-APC ) may inhibit this process and thereby improve patient outcome .
METHODS	A prospective randomized , saline-controlled , single-blinded clinical trial was performed in the intensive care units of two university hospitals , and patients with ARDS were included within 24 h after meeting inclusion criteria .
METHODS	A 4-day course of intravenous rh-APC ( 24 mcg/kg/h ) ( n = 33 ) versus saline ( n = 38 ) .
RESULTS	The primary outcome parameter was the pulmonary leak index ( PLI ) of 67Gallium-transferrin as a measure of alveolocapillary permeability and secondary outcomes were disease severity scores and ventilator-free days , among others .
RESULTS	Baseline characteristics were similar ; in 87 % of patients the PLI was above normal and in 90 % mechanical or non-invasive ventilation was instituted at a median lung injury score of 2.5 .
RESULTS	There was no evidence that Rh-APC treatment affected the PLI or attenuated lung injury and sequential organ failure assessment scores .
RESULTS	Mean ventilator-free days amounted to 14 ( rh-APC ) and 12 days ( saline , P = 0.35 ) .
RESULTS	28-day mortality was 6 % in rh-APC - and 18 % in saline-treated patients ( P = 0.12 ) .
RESULTS	There was no difference in bleeding events .
RESULTS	The study was prematurely discontinued because rh-APC was withdrawn from the market .
CONCLUSIONS	There is no evidence that treatment with intravenous rh-APC during 4 days for infectious or inflammatory ARDS ameliorates increased alveolocapillary permeability or the clinical course of ARDS patients .
CONCLUSIONS	We can not exclude underpowering .
BACKGROUND	Nederlands Trial Register ISRCTN 52566874 .

###24492985
OBJECTIVE	To assess the efficacy and safety of once daily olmesartan medoxomil ( OM ) / amlodipine besylate ( AM ) / hydrochlorothiazide ( HCTZ ) 40/10/25 mg in patients with hypertension not at goal with mono , dual or triple drug therapy .
METHODS	This was a single-center , prospective , open-label , blinded-endpoint study .
METHODS	After a 1-week screening visit , 40 patients were enrolled into the study and given once daily treatment with OM/AM/HCTZ after the patients underwent baseline ambulatory blood pressure monitoring ( ABPM ) on their original therapy .
METHODS	The primary endpoint was changes from baseline in mean 24 h ABPM [ systolic blood pressure ( SBP ) ] after the first day of therapy with OM/AM/HCTZ 40/10/25 mg .
METHODS	Secondary endpoints were changes from baseline in mean 24 h ABPM [ diastolic blood pressure ( DBP ) ] after the first day of therapy with OM/AM/HCTZ 40/10/25 mg ; mean changes from baseline in trough seated SBP ( SeSBP ) at day 1 and SeSBP at weeks 1 , 2 , 3 and 4 ; mean changes from baseline in trough seated DBP ( SeDBP ) at day 1 and SeDBP at weeks 1 , 2 , 3 and 4 ; and the percentage of subjects achieving mean 24 h , daytime and night-time ABPM BP goals .
RESULTS	The baseline paired t-test systolic ABPM was 134.0 2.77 mmHg and day 1 was 128.6 2.47 mmHg with a treatment difference of -5.55 1.3 mmHg ( p < 0.0001 ) .
RESULTS	At week 1 , paired t-test ABPM SBP reduction was 117.7 2.0 mmHg with a treatment difference of -16.5 1.8 mmHg ( p < 0.0001 ) .
RESULTS	At week 2 , paired t-test ABPM SBP reduction was 115.8 1.8 mmHg with a treatment difference of -18.4 2.0 mmHg ( p < 0.0001 ) .
RESULTS	At week 3 , paired t-test ABPM SBP reduction was 115.5 1.9 mmHg with a treatment difference of -18.6 2.0 mmHg ( p < 0.0001 ) .
RESULTS	At week 4 , paired t-test ABPM SBP reduction was 115.5 1.8 mmHg with a treatment difference of -18.6 2.2 mmHg ( p < 0.0001 ) .
RESULTS	The baseline paired t-test SeSBP was 142 2.43 mmHg and day 1 was 132 2.59 mmHg with a treatment difference of -9.78 1.51 mmHg ( p < 0.0001 ) .
RESULTS	At week 1 , paired t-test SeSBP reduction was 124.0 1.6 mmHg with a treatment difference of -17.9 1.8 mmHg ( p < 0.0001 ) .
RESULTS	At week 2 , paired t-test SeSBP reduction was 120.3 1.7 mmHg with a treatment difference of -21.5 2.1 mmHg ( p < 0.0001 ) .
RESULTS	At week 3 , paired t-test SeSBP reduction was 118.5 1.8 mmHg with a treatment difference of -23.3 1.7 mmHg ( p < 0.0001 ) .
RESULTS	At week 4 , paired t-test SeSBP reduction was 119.6 1.7 mmHg with a treatment difference of -22.2 1.9 mmHg ( p < 0.0001 ) .
CONCLUSIONS	Treatment with OM/AM/HCTZ achieved superior ( SBP ) ABPM reductions compared with mono , dual or triple drug therapy , resulting in all patients achieving systolic ABPM goal without ABPM documented hypotension .

###26200520
OBJECTIVE	To examine whether sleep disturbance is associated with poor physical function in older veterans in an adult day healthcare ( ADHC ) program .
METHODS	Cross-sectional .
METHODS	One ADHC program in a Veterans Affairs Ambulatory Care Center .
METHODS	Older veterans ( N = 50 ) enrolled in a randomized controlled trial of a sleep intervention program who had complete baseline data .
METHODS	Information on participant characteristics ( e.g. , age , depression , relationship to caregiver , pain , comorbidity ) was collected using appropriate questionnaires .
METHODS	Physical function was measured using activity of daily living ( ADL ) and instrumental ADL ( IADL ) total scores from the Older Americans Resources and Services Multidimensional Functional Assessment Questionnaire .
METHODS	Sleep was assessed subjectively ( Pittsburgh Sleep Quality Index , Insomnia Severity Index ) and objectively ( wrist actigraphy ) .
RESULTS	Participants required substantial assistance with ADLs and IADLs .
RESULTS	A regression model showed that participant characteristics ( marital status , use of sleep medication , comorbidity , posttraumatic stress disorder ) and living arrangement ( living with a spouse or others ) were significantly associated with poor physical function .
RESULTS	Poorer objective sleep ( total sleep time , total numbers of awakenings , total wake time ) was significantly associated with poor physical function , accounting for a significant proportion of the variance other than participant characteristics .
CONCLUSIONS	Objective measures of nighttime sleep disturbance were associated with poor physical function in older veterans in an ADHC program .
CONCLUSIONS	Further research is needed to determine whether interventions to improve sleep will delay functional decline in this vulnerable population .

###25515666
BACKGROUND	Shoulder instability is a common problem affecting young adults .
BACKGROUND	Stabilization surgery followed by physiotherapy rehabilitation has been shown to reduce the chance of further episodes of shoulder dislocation and to improve quality of life in patients who sustain a shoulder dislocation as a result of a high collision trauma , but it is unclear if surgical intervention is beneficial for patients with atraumatic shoulder instability who have structural damage at the shoulder .
BACKGROUND	The aim of this randomized controlled clinical trial is to determine if the addition of surgical intervention to physiotherapy rehabilitation improves outcomes for patients with atraumatic shoulder instability who have sustained soft tissue damage at their joint .
METHODS	140 participants will be recruited .
METHODS	Patients with feelings of insecurity ( apprehension ) at their shoulder joint , which is not the result of a collision injury , with physical signs of shoulder joint instability will be invited to participate .
METHODS	Consenting participants will undergo arthroscopic investigation of the shoulder joint .
METHODS	Patients with capsulolabral damage will be randomly allocated using a concealed allocation procedure to either stabilization surgery immediately following the arthroscopic examination or no additional surgical procedure .
METHODS	All participants will then receive the same postoperative physiotherapy protocol for up to 6 months .
METHODS	Outcomes ( pain , functional impairment and number of shoulder dislocations sustained ) will be evaluated prior to surgery and , together with participant-reported improvement , again at 6 , 12 and 24 months after randomization .
METHODS	The primary endpoint will be pain and functional impairment at 2 years .
METHODS	Participants , clinical staff ( but not surgeons ) and assessors will be blind to whether stabilization surgery was performed .
METHODS	Data analysis will be conducted on an intention-to-treat basis with the focus on estimation of the effect .
CONCLUSIONS	This trial will have a direct and immediate impact on clinical decision making by establishing if patients presenting with soft tissue shoulder damage associated with atraumatic shoulder instability should be referred for stabilization surgery before commencing physiotherapy rehabilitation in order to ensure optimal outcome .
CONCLUSIONS	This in turn will ensure effective , efficient use of scarce health resources to manage this common often disabling musculoskeletal condition .
BACKGROUND	Study was registered with National Institutes of Health Clinical Trials Protocol Registration System in December 2012 .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01751490 .

###25196040
BACKGROUND	This study assessed the effects of two doses of glucose and a caffeine-glucose combination on mood and performance of an ecologically valid , computerised multi-tasking platform .
METHODS	Following a double-blind , placebo-controlled , randomised , parallel-groups design , 150 healthy adults ( mean age 34.78 years ) consumed drinks containing placebo , 25g glucose , 60g glucose or 60g glucose with 40mg caffeine .
METHODS	They completed a multi-tasking framework at baseline and then 30min following drink consumption with mood assessments immediately before and after the multi-tasking framework .
METHODS	Blood glucose and salivary caffeine were co-monitored .
RESULTS	The caffeine-glucose group had significantly better total multi-tasking scores than the placebo or 60g glucose groups and were significantly faster at mental arithmetic tasks than either glucose drink group .
RESULTS	There were no significant treatment effects on mood .
RESULTS	Caffeine and glucose levels confirmed compliance with overnight abstinence/fasting , respectively , and followed the predicted post-drink patterns .
CONCLUSIONS	These data suggest that co-administration of glucose and caffeine allows greater allocation of attentional resources than placebo or glucose alone .
CONCLUSIONS	At present , we can not rule out the possibility that the effects are due to caffeine alone Future studies should aim at disentangling caffeine and glucose effects .

###24898236
BACKGROUND	Breakfast is associated with lower body weight in observational studies .
BACKGROUND	Public health authorities commonly recommend breakfast consumption to reduce obesity , but the effectiveness of adopting these recommendations for reducing body weight is unknown .
OBJECTIVE	We tested the relative effectiveness of a recommendation to eat or skip breakfast on weight loss in adults trying to lose weight in a free-living setting .
METHODS	We conducted a multisite , 16-wk , 3-parallel-arm randomized controlled trial in otherwise healthy overweight and obese adults [ body mass index ( in kg/m ) between 25 and 40 ] aged 20-65 y.
METHODS	Our primary outcome was weight change .
METHODS	We compared weight change in a control group with weight loss in experimental groups told to eat breakfast or to skip breakfast [ no breakfast ( NB ) ] .
METHODS	Randomization was stratified by prerandomization breakfast eating habits .
METHODS	A total of 309 participants were randomly assigned .
RESULTS	A total of 283 of the 309 participants who were randomly assigned completed the intervention .
RESULTS	Treatment assignment did not have a significant effect on weight loss , and there was no interaction between initial breakfast eating status and treatment .
RESULTS	Among skippers , mean ( SD ) baseline weight - , age - , sex - , site - , and race-adjusted weight changes were -0.71 1.16 , -0.76 1.26 , and -0.61 1.18 kg for the control , breakfast , and NB groups , respectively .
RESULTS	Among breakfast consumers , mean ( SD ) baseline weight - , age - , sex - , site - , and race-adjusted weight changes were -0.53 1.16 , -0.59 1.06 , and -0.71 1.17 kg for the control , breakfast , and NB groups , respectively .
RESULTS	Self-reported compliance with the recommendation was 93.6 % for the breakfast group and 92.4 % for the NB group .
CONCLUSIONS	A recommendation to eat or skip breakfast for weight loss was effective at changing self-reported breakfast eating habits , but contrary to widely espoused views this had no discernable effect on weight loss in free-living adults who were attempting to lose weight .

###24639094
BACKGROUND	Although blood flow-restricted low-intensity resistance training ( BFR-RT ) increases muscle size and strength in older adults , the effect of detraining on muscle adaptation is unclear .
METHODS	We investigated the effects of 24weeks of detraining on thigh muscle cross-sectional area ( CSA ) and one-repetition maximum strength ( 1-RM ) in older adults who had previously participated in 12weeks of training ( BFR-RT , 20-30 % 1-RM , knee extension and leg press ) or non-BFR training .
RESULTS	Both 1-RM and relative dynamic strengths ( 1-RM divided by quadriceps femoris ( QF ) muscle CSA ) were higher at both post-training and detraining than at pre-training for the BFR-RT group ( p < 0.05 ) .
RESULTS	QF muscle CSA was higher at only post-training than at pre-training for the BFR-RT group ( p < 0.01 ) .
CONCLUSIONS	Increased muscle strength following 12weeks of training with BFR-RT was well preserved at 24weeks of detraining , which is due mainly to neural adaptation in older adults .

###24768290
BACKGROUND	Acute radicular back pain is a frequent complaint of patients presenting to the Emergency Department .
OBJECTIVE	Determine the efficacy of intravenous lidocaine when compared to ketorolac for the treatment of acute radicular low back pain .
METHODS	Randomized double-blind study of 41 patients aged 18-55 years presenting with acute radicular low back pain .
METHODS	Patients were randomized to receive either 100 mg lidocaine or 30 mg ketorolac intravenously over 2 min .
METHODS	A 100-mm visual analog scale ( VAS ) was used to assess pain at Time 0 ( baseline ) , and 20 , 40 , and 60 minutes .
METHODS	Changes in [ median ] VAS scores were compared over time ( within groups ) by the signed-rank test and between groups by the rank-sum test .
METHODS	A 5-point Pain Relief Scale ( PRS ) was administered at the conclusion of the study ( 60 min ) and again at 1 week by telephone follow-up ; [ median ] scores were compared between groups by rank-sum .
RESULTS	Forty-four patients were recruited ; 41 completed the study ( 21 lidocaine , 20 ketorolac ) .
RESULTS	Initial VAS scores were not significantly different between the lidocaine and ketorolac groups ( 83 ; 95 % confidence interval [ CI ] 74-98 vs. 79 ; 95 % CI 64-94 ; p = 0.278 ) .
RESULTS	Median VAS scores from baseline to 60 min significantly declined in both groups ( lidocaine [ 8 ; 95 % CI 0-23 ; p = 0.003 ] ; ketorolac [ 14 ; 95 % CI 0-28 ; p = 0.007 ] ) , with no significant difference in the degree of reduction between groups ( p = 0.835 ) .
RESULTS	Rescue medication was required by 67 % receiving lidocaine , compared to 50 % receiving ketorolac .
RESULTS	No significant change in PRS between groups was found at the conclusion or at the follow-up .
CONCLUSIONS	Intravenous lidocaine failed to clinically alleviate the pain associated with acute radicular low back pain .

###24774590
OBJECTIVE	Hospitalized patients with heart failure who are malnourished present a worse prognosis than those with an adequate nutritional status .
OBJECTIVE	It is unknown whether a nutritional intervention can modify the prognosis of these patients .
OBJECTIVE	The aim of this study is to assess the efficacy of a nutritional intervention on morbidity and mortality in hospitalized patients with heart failure who are malnourished .
METHODS	PICNIC is a multicentre , randomized , controlled trial in which hospitalized patients with heart failure and malnutrition , as defined by the Mini Nutritional Assessment , are randomly assigned to conventional management of heart failure or conventional management of heart failure and an individualized nutritional intervention consisting of 3 points : optimization of diet , specific recommendations , and prescription , if deemed necessary , of nutritional supplements .
METHODS	A sample size of 182 patients for a maximum follow-up of 12 months has been estimated .
METHODS	The primary endpoint is time to death from any cause or rehospitalization because of heart failure .
METHODS	Analysis is by intention to treat .
CONCLUSIONS	PICNIC study will determine the prognostic impact of a nutritional intervention in hospitalized patients with heart failure who are malnourished .

###25629740
BACKGROUND	Angioedema induced by treatment with angiotensin-converting-enzyme ( ACE ) inhibitors accounts for one third of angioedema cases in the emergency room ; it is usually manifested in the upper airway and the head and neck region .
BACKGROUND	There is no approved treatment for this potentially life-threatening condition .
METHODS	In this multicenter , double-blind , double-dummy , randomized phase 2 study , we assigned patients who had ACE-inhibitor-induced angioedema of the upper aerodigestive tract to treatment with 30 mg of subcutaneous icatibant , a selective bradykinin B2 receptor antagonist , or to the current off-label standard therapy consisting of intravenous prednisolone ( 500 mg ) plus clemastine ( 2 mg ) .
METHODS	The primary efficacy end point was the median time to complete resolution of edema .
RESULTS	All 27 patients in the per-protocol population had complete resolution of edema .
RESULTS	The median time to complete resolution was 8.0 hours ( interquartile range , 3.0 to 16.0 ) with icatibant as compared with 27.1 hours ( interquartile range , 20.3 to 48.0 ) with standard therapy ( P = 0.002 ) .
RESULTS	Three patients receiving standard therapy required rescue intervention with icatibant and prednisolone ; 1 patient required tracheotomy .
RESULTS	Significantly more patients in the icatibant group than in the standard-therapy group had complete resolution of edema within 4 hours after treatment ( 5 of 13 vs. 0 of 14 , P = 0.02 ) .
RESULTS	The median time to the onset of symptom relief ( according to a composite investigator-assessed symptom score ) was significantly shorter with icatibant than with standard therapy ( 2.0 hours vs. 11.7 hours , P = 0.03 ) .
RESULTS	The results were similar when patient-assessed symptom scores were used .
CONCLUSIONS	Among patients with ACE-inhibitor-induced angioedema , the time to complete resolution of edema was significantly shorter with icatibant than with combination therapy with a glucocorticoid and an antihistamine .
CONCLUSIONS	( Funded by Shire and the Federal Ministry of Education and Research of Germany ; ClinicalTrials.gov number , NCT01154361 . )

###24375720
BACKGROUND	Deep brain stimulation ( DBS ) of the globus pallidus internus is an effective treatment for cervical dystonia ( CD ) .
BACKGROUND	Interestingly , the onset of initial DBS effects is significantly prolonged compared with that in other diseases , such as Parkinson 's disease .
BACKGROUND	The return of symptoms after cessation of DBS could be delayed as well , but this has not been studied systematically .
METHODS	In patients who were treated for CD using DBS and had a good treatment effect , we compared interruption of DBS with sham-OFF in a randomized , double-blind crossover trial .
RESULTS	We observed that dystonic features appeared within a few minutes at almost full intensity in all patients after the cessation of DBS .
CONCLUSIONS	The almost immediate onset of dystonic features in our sample seems to exclude mechanisms with long time constants from the pathophysiology of dystonia .
CONCLUSIONS	Thus , it is likely that , in these patients , an aberrant pattern of neural activity representing an inappropriate set point value for the position of the head is responsible for dystonia .

###24229084
BACKGROUND	Adequate biomarkers for the dietary supply of fatty acids ( FA ) are FA of adipose tissue and blood fractions .
BACKGROUND	In human studies , invasive sample collection is unpleasant for subjects .
BACKGROUND	In contrast , cheek cell sampling can be considered as a non-invasive alternative to investigate FA status.The aim of this study was to analyze whether cheek cell FA composition reflect the supplementation of alpha-linolenic acid ( ALA ) using a linseed oil mixture compared to olive oil supplementation .
BACKGROUND	Additionally , it was investigated if cheek cell FA composition correlates with the FA composition of plasma , red blood cells ( RBC ) and peripheral blood mononuclear cells ( PBMC ) before and during both interventions .
METHODS	During a 10-week randomized , controlled , double-blind human intervention study , 38 subjects provided cheek cell and blood samples .
METHODS	After a two-week run-in period , the test group ( n = 23 ) received 17 g/d of an ALA-rich linseed oil mixture , while the control group ( n = 15 ) received 17 g/d of an omega-3 ( n-3 ) polyunsaturated FA ( PUFA ) - free olive oil .
METHODS	Cheek cells and blood were collected on days 0 , 7 and 56 of the 8-week intervention period .
RESULTS	Compared to olive oil , the linseed oil intervention increased ALA and also the endogenously converted long-chain n-3 metabolites eicosatetraenoic - , eicosapentaenoic - and docosapentaenoic acid in cheek cells ( P0 .05 ) .
RESULTS	Docosahexaenoic acid remained unchanged .
RESULTS	Reflecting the treatment , the n-6 / n-3 ratio decreased in the test group .
RESULTS	In general , cheek cell FA reflected the changes of FA in blood fractions .
RESULTS	Independent of treatment , significant correlations ( P0 .05 ) of n-6 PUFA and n-3 PUFA between cheek cells and plasma , RBC and PBMC were found , except for linoleic acid and ALA. .
CONCLUSIONS	The changes in FA composition of cheek cells confirmed that ALA from linseed oil increased endogenously derived n-3 PUFA in cheek cell lipids .
CONCLUSIONS	These changes in cheek cells and their correlation to the respective FA in blood fractions indicate the cheek cell FA profile as an adequate non-invasive biomarker for short-term n-3 PUFA intake and metabolism .
CONCLUSIONS	Therefore , cheek cell FA can be used in human intervention studies or large-scale epidemiological studies , especially for assessment of the n-3 PUFA status .
BACKGROUND	ClinicalTrials.gov , IDNCT01317290 .

###24332997
BACKGROUND	Iron supplementation for hypoferremic anemia could potentiate bacterial growth in the cystic fibrosis ( CF ) lung , but clinical trials testing this hypothesis are lacking .
METHODS	Twenty-two adults with CF and hypoferremic anemia participated in a randomized , double-blind , placebo-controlled , crossover trial of ferrous sulfate 325mg daily for 6weeks .
METHODS	Iron-related hematologic parameters , anthropometric data , sputum iron , Akron Pulmonary Exacerbation Score ( PES ) , and the sputum microbiome were serially assessed .
METHODS	Fixed-effect models were used to describe how ferrous sulfate affected these variables .
RESULTS	Ferrous sulfate increased serum iron by 22.3 % and transferrin saturation ( TSAT ) by 26.8 % from baseline ( p < 0.05 ) but did not affect hemoglobin , sputum iron , Akron PES , and the sputum microbiome .
CONCLUSIONS	Low-dose ferrous sulfate improved hypoferremia without correcting anemia after 6weeks .
CONCLUSIONS	We did not observe significant effects on sputum iron , Akron PES , and the sputum microbiome .
CONCLUSIONS	Although we did not identify untoward health effects of iron supplementation , a larger blinded randomized controlled trial would be needed to fully demonstrate safety .

###26175279
BACKGROUND	Although totally implantable venous access devices ( TIVAD ) are increasingly being used in oncology patients , more robust evidence about the best technique is lacking , especially regarding to ultrasound ( US ) guided puncture .
METHODS	One hundred ten patients with indication of intravenous chemotherapy were randomly assigned to TIVAD implant through US-guided internal jugular vein ( USG ) puncture ( 39 ) or internal jugular vein blindly ( IJB ) ( 36 ) or subclavian vein blindly ( SCB ) ( 35 ) .
METHODS	Procedure data and complications were prospectively recorded within 30 days of the procedure .
RESULTS	All patients completed the follow up .
RESULTS	Immediate complication rate was 5.1 % , 13.9 % , and 0 % in the USG , IJB , and SCB groups , respectively ( P = 0.05 ) .
RESULTS	First attempt success rate was 79.5 % in the USG , 52.8 % in the IJB and 47.2 % in the SCB group ( P = 0.012 ) .
RESULTS	Technique failure was observed in 2.6 % , 22.2 % , and 8.6 % of the population in the USG , IJB , and SCB , respectively ( P = 0.021 ) .
RESULTS	Early complication rate was 5.1 % in USG group , 2.8 % in the IJB , and 0 % in the SCB ( P = 0.401 ) .
CONCLUSIONS	The findings of our study suggest superiority of the USG approach in terms of first puncture success rate and technique failure , without increasing the procedure duration .
CONCLUSIONS	Long-term follow-up results should help to further clarify the current debates .

###24373006
BACKGROUND	Many studies have examined laser treatment of scars , but cosmetic results have been variable .
BACKGROUND	Although no studies have examined the effect of purpura on scar improvement using the pulsed dye laser ( PDL ) , many clinicians believe inducing purpura results in better and quicker improvement .
OBJECTIVE	To determine whether PDL treatment of fresh surgical scars with purpura-inducing settings improves clinical appearance more than non-purpura-inducing settings or no treatment .
METHODS	Twenty-six subjects with surgical scars enrolled in this prospective study .
METHODS	Scars were divided into three equal segments ; treatment was randomized : 595-nm PDL with purpuric ( 1.5 ms ) or nonpurpuric ( 10ms ) settings or no treatment .
METHODS	Fluences were adjusted to Fitzpatrick skin type .
METHODS	Scars were treated three times , 1month apart , beginning at suture removal .
METHODS	Outcome measures included Vancouver Scar Scale ( VSS ) and blind clinical ratings .
RESULTS	The nonpurpuric condition showed significant improvement on the VSS total score , vascularity , and pliability ratings .
RESULTS	The purpuric condition demonstrated a trend for improvement on the VSS total .
RESULTS	According to blind observer ratings , all conditions improved , without differences between groups .
CONCLUSIONS	Nonpurpuric settings on the PDL resulted in significant improvements in the appearance of fresh surgical scars for vascularity , pliability , and VSS total scores , although all scar segments improved over time .

###24877078
OBJECTIVE	Persistent weakness is a common problem after anterior cruciate ligament - ( ACL - ) reconstruction .
OBJECTIVE	This study investigated the effects of high-intensity ( HRT ) versus low-intensity ( LRT ) resistance training on leg extensor power and recovery of knee function after ACL-reconstruction .
METHODS	31 males and 19 females were randomized to HRT ( n = 24 ) or LRT ( n = 26 ) from week 8-20 after ACL-reconstruction .
METHODS	Leg extensor power , joint laxity , and self-reported knee function were measured before and 7 , 14 , and 20 weeks after surgery .
METHODS	Hop tests were assessed before and after 20 weeks .
RESULTS	Power in the injured leg was 90 % ( 95 % CI 86-94 % ) of the noninjured leg , decreasing to 64 % ( 95 % CI 60-69 % ) 7 weeks after surgery .
RESULTS	During the resistance training phase there was a significant group by time interaction for power ( P = 0.020 ) .
RESULTS	Power was regained more with HRT compared to LRT at week 14 ( 84 % versus 73 % of noninjured leg , resp. ; P = 0.027 ) and at week 20 ( 98 % versus 83 % of noninjured leg , resp. ; P = 0.006 ) without adverse effects on joint laxity .
RESULTS	No other between-group differences were found .
CONCLUSIONS	High-intensity resistance training during rehabilitation after ACL-reconstruction can improve muscle power without adverse effects on joint laxity .

###25227538
BACKGROUND	Functional electrical stimulation ( FES ) to patients early after stroke has been proved to improve walking ability .
BACKGROUND	The effects on abilities in activities of daily living ( ADL ) are not clear .
OBJECTIVE	To investigate the effectiveness of FES in improving lower limb function and ability in ADL of early stroke patients .
METHODS	Thirty-seven stroke patients were randomly allocated to standard rehabilitation ( SR ) group ( n = 18 ) , and FES group with FES and SR ( n = 19 ) .
METHODS	SR included 60 minutes each for physiotherapy and occupational therapy .
METHODS	FES was delivered for 30 min to induce ankle dorsiflexion and eversion .
METHODS	Treatments were 5 days per week for 3 weeks .
METHODS	Evaluations including the composite spasticity scale ( CSS ) , lower-extremity subscale of Fugl-Myer Assessment ( FMA ) , postural assessment scale for stroke patients ( PASS ) , Berg Balance Scale ( BBS ) , and modified Barthel Index ( MBI ) assessed before treatment , after 2 and 3 week treatment respectively .
RESULTS	After 2 week treatment , FES group showed a significant reduction of CSS and improvements of FMA , MBI and PASS .
RESULTS	After 3 week treatment , FES group showed a further reduction of CSS and also improvement of FMA , MBI and BBS as well .
CONCLUSIONS	FES on the paretic lower limbs early after stroke improved the mobility and ability in ADL .

###25539730
BACKGROUND	The role of bleomycin and dacarbazine in the ABVD regimen ( ie , doxorubicin , bleomycin , vinblastine , and dacarbazine ) has been questioned , especially for treatment of early-stage favourable Hodgkin 's lymphoma , because of the drugs ' toxicity .
BACKGROUND	We aimed to investigate whether omission of either bleomycin or dacarbazine , or both , from ABVD reduced the efficacy of this regimen in treatment of Hodgkin 's lymphoma .
METHODS	In this open-label , randomised , multicentre trial ( HD13 ) we compared two cycles of ABVD with two cycles of the reduced-intensity regimen variants ABV ( doxorubicin , bleomycin , and vinblastine ) , AVD ( doxorubicin , vinblastine , and dacarbazine ) , and AV ( doxorubicin and vinblastine ) , in patients with newly diagnosed , histologically proven , classic or nodular , lymphocyte predominant Hodgkin 's lymphoma .
METHODS	In each treatment group , 30 Gy involved-field radiotherapy ( IFRT ) was given after both cycles of chemotherapy were completed .
METHODS	From Jan 28 , 2003 , patients were centrally randomly assigned ( 1:1:1:1 ) with a minimisation method to the four groups .
METHODS	Because of high event rates , assignment to the AV and ABV groups stopped early , on Sept 30 , 2005 , and Feb 10 , 2006 ; assignment to ABVD and AVD continued ( 1:1 ) until Sept 30 , 2009 .
METHODS	Our primary objective was to show non-inferiority of the experimental variants compared with ABVD in terms of freedom from treatment failure ( FFTF ) , by excluding a difference of 6 % after 5 years corresponding to a hazard ratio ( HR ) of 1.72 , via a 95 % CI .
METHODS	Analyses reported here include qualified patients only , and between-group comparisons include only patients recruited during the same period .
METHODS	The trial was registered , number ISRCTN63474366 .
RESULTS	Of 1502 qualified patients , 566 , 198 , 571 , and 167 were randomly assigned to receive ABVD , ABV , AVD , or AV , respectively .
RESULTS	5 year FFTF was 93.1 % , 81.4 % , 89.2 % , and 77.1 % with ABVD , ABV , AVD , and AV , respectively .
RESULTS	Compared with ABVD , inferiority of the dacarbazine-deleted variants was detected with 5 year differences of -11.5 % ( 95 % CI -18.3 to -4.7 ; HR 2.06 [ 1.21 to 3.52 ] ) for ABV and -15.2 % ( -23.0 to -7.4 ; HR 2.57 [ 1.51 to 4.40 ] ) for AV .
RESULTS	Non-inferiority of AVD compared with ABVD could also not be detected ( 5 year difference -3.9 % , -7.7 to -01 ; HR 1.50 , 1.00 to 2.26 ) .
RESULTS	178 ( 33 % ) of 544 patients given ABVD had WHO grade III or IV toxicity , compared with 53 ( 28 % ) of 187 given ABV , 142 ( 26 % ) of 539 given AVD , and 40 ( 26 % ) of 151 given AV .
RESULTS	Leucopenia was the most common event , and highest in the groups given bleomycin .
CONCLUSIONS	Dacarbazine can not be omitted from ABVD without a substantial loss of efficacy .
CONCLUSIONS	With respect to our predefined non-inferiority margin , bleomycin can not be safely omitted either , and the standard of care for patients with early-stage favourable Hodgkin 's lymphoma should remain ABVD followed by IFRT .
BACKGROUND	Deutsche Krebshilfe and Swiss State Secretariat for Education and Research .

###24571702
OBJECTIVE	To assess the potential of a stabilised stannous ( Sn ) - containing NaF dentifrice ( Oral B/blend-a-Med ( ) Pro-Expert ) , in addition to a number of other marketed European dentifrices formulated with various fluoride actives and two control dentifrices , to protect enamel against erosive acid damage .
METHODS	Cores of human enamel ( four per group ) were soaked in pooled human saliva , and then treated with a 1:3 slurry ( dentifrice : saliva ) using a standardised in vitro erosion model ( 5-day cycling ) that includes 10-minute challenges with 1 % citric acid applied 60 minutes after each dentifrice treatment .
METHODS	Enamel surface loss was measured using transverse microradiography ( TMR ) .
RESULTS	Specimens treated with the Sn-containing NaF dentifrice showed 6.5 m of surface loss 1.2 ( SEM ) , which was not significantly different ( P < 0.05 , Fisher LSD ) from that of a clinically proven , stabilised SnF2 positive control [ Crest ( ) Pro-Health , 1,100 ppm F as SnF2 : 3.0 m of surface loss 1.1 ( SEM ) ] .
RESULTS	The Sn-containing NaF dentifrice and the clinically proven positive control both provided significantly greater protection ( P < 0.05 , Fisher LSD ) compared with all of the other products tested .
RESULTS	Enamel loss ( SEM ) values for other European products and the reference control ( active agents ) were : Meridol ( ) : ( 1,400 ppm F as AmF + SnF2 ) 12.0 m ( 1.47 ) ; Colgate ( ) Cavity Protection : ( 1,450 ppm F as SMFP + NaF ) 12.9 m ( 1.66 ) ; Odol med 3 ( ) ( 1,400 ppm F as NaF ) 14.2 m ( 1.49 ) ; Elmex ( ) ( 1,400 ppm F as AmF ) 14.5 m ( 1.76 ) ; Colgate ( ) Enamel Protect : ( 1,450 ppm F as NaF + KNO3 ) 16.3 m ( 2.02 ) ; Lacalut ( ) aktiv : ( 1,400 ppm F as AlF3 ) 18.5 m ( 1.71 ) ; Sensodyne ( ) ProNamel ( ) : ( 1,450 ppm F as NaF + KNO3 ) 20.5 m ( 1.26 ) ; Crest Cavity Protection ( 1,100 ppm F as NaF , reference control ) 22.00 m ( 2.04 ) ; and Mentadent ( ) : ( 1,450 ppm F as NaF + Zn citrate ) 22.3 m ( 0.63 ) .
CONCLUSIONS	These results support the potential for the stabilised , Sn-containing NaF dentifrice to provide erosion protection benefits that are not significantly different from the positive control benchmark for erosion protection ( stabilised SnF2 ) , and are significantly better than a broad range of dentifrice formulations available on the European market .

###24557758
OBJECTIVE	To verify the efficacy to obtain mydriasis and cardiovascular safety of Mydriasert ( ophthalmic insert containing tropicamide and phenylephrine ) in diabetic and nondiabetic patients undergoing retinal angiography by comparing it with usually administered eyedrops ( tropicamide 1 % and phenylephrine 10 % ) .
METHODS	This was a prospective randomized study .
METHODS	A total of 154 eyes of 77 patients were randomly divided into 2 groups : group 1 consisted of 78 eyes , group 2 consisted of 76 eyes , and the patients were monitored for pupillary dilation , blood pressure , heart rate , and possible adverse effects at 0 , 20 , 40 , 60 , and 90 minutes .
RESULTS	No severe adverse effects were observed in either group .
RESULTS	In the entire sample studied , the mean pupillary diameter was greater in the eyedrops group after 20 and 40 minutes , while mydriasis was similar in the 2 groups after 60 minutes .
RESULTS	The diabetic patients treated with Mydriasert had less mydriasis than those treated with eyedrops after 20 and 40 minutes , and diabetic patients showed less mydriasis than the nondiabetic patients after 60 and 90 minutes .
RESULTS	There was no significant between-group difference in mean heart rate or systolic and diastolic blood pressure at any of the time points .
CONCLUSIONS	Mydriasert assures an adequate degree of mydriasis for retinal angiography in both diabetic and nondiabetic patients .
CONCLUSIONS	There are no differences in efficacy or safety between the insert and the usually administered eyedrops , but the low total drug dose administered with the insert reduces the risk of cardiovascular side effects .

###24320833
OBJECTIVE	The purpose of this study was to assess the impact of a mental illness self-management intervention , called Wellness Recovery Action Planning ( WRAP ) , on the use of and need for mental health services over time compared with nutrition and wellness education .
METHODS	Participants were recruited from outpatient community mental health settings in Chicago , Illinois .
METHODS	Using a single-blind , randomized controlled trial design , 143 individuals were assigned to WRAP or to a nutrition education course and assessed at baseline and at 2-month and 8-month follow-up .
METHODS	The WRAP intervention was delivered by peers in recovery from serious mental illness who were certified WRAP educators over nine weekly sessions lasting 2.5 hrs .
METHODS	The nutrition education curriculum was taught by trained non-peer educators using the same schedule .
METHODS	Mixed-effects random regression analysis tested for differences between the two interventions in ( a ) self-reported use of 19 clinical , rehabilitation , peer , emergent , and ancillary services ; and ( b ) self-reported need for these services .
RESULTS	Results of mixed-effects random regression analysis indicated that , compared with controls , WRAP participants reported significantly greater reduction over time in service utilization ( total , individual , and group ) , and service need ( total and group services ) .
RESULTS	Participants in both interventions improved significantly over time in symptoms and recovery outcomes .
CONCLUSIONS	Training in mental illness self-management reduced the self-reported need for and use of formal mental health services over time .
CONCLUSIONS	This confirms the importance of WRAP in an era of dwindling behavioral health service availability and access .

###25266289
BACKGROUND	Virologic failure following treatment of hepatitis C virus ( HCV ) genotype 1 with direct-acting antiviral agents is often accompanied by the emergence of resistant variants .
BACKGROUND	MK-5172 is an investigational once-daily protease inhibitor .
BACKGROUND	We analyzed variants in treatment-naive noncirrhotic patients with virologic failure on MK-5172 ( 100-800 mg/day ) plus pegylated interferon alfa/ribavirin ( peg-IFN/RBV ) during a phase 2 trial .
METHODS	Population and selective clonal sequencing were performed at baseline and at virologic failure in the 4 MK-5172 dosing arms .
METHODS	MK-5172 activity was determined using a mutant replicon assay .
RESULTS	Six of 266 ( 2.3 % ) MK-5172 recipients satisfied prespecified criteria for virologic failure , all with genotype 1a infection .
RESULTS	Five patients with virologic failure were in the MK-5172 100-mg arm , including 4 patients with low plasma MK-5172 levels documented during triple therapy .
RESULTS	Variants associated with > 4-fold loss of potency were detected in 3 of the 4 patients with genotype 1a breakthrough while on MK-5172 .
RESULTS	The fifth patient had undetectable HCV-RNA levels at the end of triple therapy but subsequently broke through during the peg-IFN/RBV tail 16 weeks after completion of MK-5172 .
RESULTS	Three patients had D168 variants at virologic failure , including 2 with the D168A variant associated with a 95-fold loss of potency .
RESULTS	The sole apparent relapse was actually a genotype 3a reinfection in the MK-5172 200-mg group .
CONCLUSIONS	Virologic failure occurred uncommonly ( 6/266 [ 2.3 % ] ) in MK-5172 / peg-IFN/RBV recipients .
CONCLUSIONS	The most prevalent treatment-emergent variants were detected at the D168 locus .
CONCLUSIONS	D168A variants conferring approximately 2-log reduction in MK-5172 susceptibility emerged in 2 of the 4 evaluable patients with genotype 1a breakthrough .
CONCLUSIONS	Clinical Trials Registration.NCT01353911 .

###25456022
BACKGROUND	This study aimed to determine the effect of cumin powder on body composition and lipid profile in overweight and obese women .
METHODS	In this randomized clinical trial , 88 overweight/obese women were randomly assigned into two groups .
METHODS	The experimental group was asked to have 3g/d cumin powder with yogurt at two meals for 3 months .
METHODS	The same amount of yogurt minus cumin powder was prescribed for the control group .
METHODS	All patients received nutrition counseling for weight loss in a similar manner .
METHODS	Anthropometric and biochemical parameters were determined before and after the intervention .
RESULTS	Cumin powder reduced serum levels of fasting cholesterol , triglyceride , and LDL and increased HDL .
RESULTS	Weight , BMI , waist circumference , fat mass and its percentage significantly reduced .
RESULTS	It has no effect on FBS and fat-free mass .
CONCLUSIONS	Cumin powder in a weight reduction diet showed improvement in anthropometric and biochemical parameters in overweight/obese women .

###25157725
OBJECTIVE	Premature infants are at risk of developing encephalopathy of prematurity , which is associated with long-term neurodevelopmental delay .
OBJECTIVE	Erythropoietin was shown to be neuroprotective in experimental and retrospective clinical studies .
OBJECTIVE	To determine if there is an association between early high-dose recombinant human erythropoietin treatment in preterm infants and biomarkers of encephalopathy of prematurity on magnetic resonance imaging ( MRI ) at term-equivalent age .
METHODS	A total of 495 infants were included in a randomized , double-blind , placebo-controlled study conducted in Switzerland between 2005 and 2012 .
METHODS	In a nonrandomized subset of 165 infants ( n = 77 erythropoietin ; n = 88 placebo ) , brain abnormalities were evaluated on MRI acquired at term-equivalent age .
METHODS	Participants were randomly assigned to receive recombinant human erythropoietin ( 3000 IU/kg ; n = 256 ) or placebo ( n = 239 ) intravenously before 3 hours , at 12 to 18 hours , and at 36 to 42 hours after birth .
METHODS	The primary outcome of the trial , neurodevelopment at 24 months , has not yet been assessed .
METHODS	The secondary outcome , white matter disease of the preterm infant , was semiquantitatively assessed from MRI at term-equivalent age based on an established scoring method .
METHODS	The resulting white matter injury and gray matter injury scores were categorized as normal or abnormal according to thresholds established in the literature by correlation with neurodevelopmental outcome .
RESULTS	At term-equivalent age , compared with untreated controls , fewer infants treated with recombinant human erythropoietin had abnormal scores for white matter injury ( 22 % [ 17/77 ] vs 36 % [ 32/88 ] ; adjusted risk ratio [ RR ] , 0.58 ; 95 % CI , 0.35-0 .96 ) , white matter signal intensity ( 3 % [ 2/77 ] vs 11 % [ 10/88 ] ; adjusted RR , 0.20 ; 95 % CI , 0.05-0 .90 ) , periventricular white matter loss ( 18 % [ 14/77 ] vs 33 % [ 29/88 ] ; adjusted RR , 0.53 ; 95 % CI , 0.30-0 .92 ) , and gray matter injury ( 7 % [ 5/77 ] vs 19 % [ 17/88 ] ; adjusted RR , 0.34 ; 95 % CI , 0.13-0 .89 ) .
CONCLUSIONS	In an analysis of secondary outcomes of a randomized clinical trial of preterm infants , high-dose erythropoietin treatment within 42 hours after birth was associated with a reduced risk of brain injury on MRI .
CONCLUSIONS	These findings require assessment in a randomized trial designed primarily to assess this outcome as well as investigation of the association with neurodevelopmental outcomes .
BACKGROUND	clinicaltrials.gov Identifier : NCT00413946 .

###25579006
OBJECTIVE	This study compared the effect of superior and inferior joint space injections of hyaluronic acid ( HA ) and evaluated osteoarthritic changes in patients diagnosed with temporomandibular joint ( TMJ ) anterior disc displacement without reduction ( ADDw/oR ) in association with osteoarthritis ( OA ) by cone-beam computed tomography ( CBCT ) .
METHODS	One hundred forty-one patients with research diagnostic criteria for ADDw/oR in association with TMJ OA were randomly assigned to 1 of 2 study groups that received superior or inferior joint space injection of HA .
METHODS	CBCT and clinical examination were performed before treatment and at 3 and 9 months after treatment .
RESULTS	One hundred twenty-six patients returned for the 3-month evaluations , and 74 returned for the 9-month evaluations .
RESULTS	Condylar remodeling and TMJ function showed improvement in most patients after treatment .
RESULTS	At 3 months , remodeling scores in the superior and inferior groups were 2.14 3.16 and 4.08 3.82 , respectively , and scores were 4.80 3.36 and 7.47 3.90 at 9 months .
RESULTS	There were significant differences between the superior and inferior groups at 3 and 9 months after treatment ( 3-month , P = .002 ; 9-month , P = .002 ) .
RESULTS	The Helkimo index of the inferior group was significantly lower than that of superior group at 3 and 9 months ( 3-month , P = .008 ; 9-month , P = .028 ) .
RESULTS	There were no significant differences in maximal mouth opening between the 2 groups at 3 and 9 months ( 3-month , P = .82 ; 9-month , P = .20 ) .
CONCLUSIONS	Superior and inferior joint space injections of HA are effective methods for the treatment of ADDw/oR in association with TMJ OA .
CONCLUSIONS	The injection of HA within the inferior joint space appears to result in better condylar reparative remodeling and improvement in jaw function .

###25295964
OBJECTIVE	To examine whether an Internet-based learning module and small-group debriefing can improve medical trainees ' attitudes and communication skills toward patients with substance use disorders ( SUDs ) .
METHODS	In 2011-2012 , 129 internal and family medicine residents and 370 medical students at two medical schools participated in a cluster randomized controlled trial , which assessed the effect of adding a two-part intervention to the SUDs curricula .
METHODS	The intervention included a self-directed , media-rich Internet-based learning module and a small-group , faculty-led debriefing .
METHODS	Primary study outcomes were changes in self-assessed attitudes in the intervention group ( I-group ) compared with those in the control group ( C-group ) ( i.e. , a difference of differences ) .
METHODS	For residents , the authors used real-time , Web-based interviews of standardized patients to assess changes in communication skills .
METHODS	Statistical analyses , conducted separately for residents and students , included hierarchical linear modeling , adjusted for site , participant type , cluster , and individual scores at baseline .
RESULTS	The authors found no significant differences between the I - and C-groups in attitudes for residents or students at baseline .
RESULTS	Compared with those in the C-group , residents , but not students , in the I-group had more positive attitudes toward treatment efficacy and self-efficacy at follow-up ( P < .006 ) .
RESULTS	Likewise , compared with residents in the C-group , residents in the I-group received higher scores on screening and counseling skills during the standardized patient interview at follow-up ( P = .0009 ) .
CONCLUSIONS	This intervention produced improved attitudes and communication skills toward patients with SUDs among residents .
CONCLUSIONS	Enhanced attitudes and skills may result in improved care for these patients .

###24354627
BACKGROUND	Malaria remains a major public health problem in developing countries .
BACKGROUND	Then in these countries prompt access to effective antimalarial treatment such as Artemisinin based-Combination Therapies ( ACT ) proves to be an essential tool for controlling the disease .
BACKGROUND	In Senegal , since 2006 a nationwide scaling up program of ACT is being implemented .
BACKGROUND	In this context it has become relevant to monitor ACT efficacy and provide recommendations for the Senegalese national malaria control program .
METHODS	An open randomized trial was conducted during two malaria transmission seasons ( 2011 and 2012 ) to assess the efficacy and safety of three combinations : dihydro-artemisinin-piperaquine ( DHAPQ ) , artemether-lumefantrine ( AL ) and artesunate-amodiaquine ( ASAQ ) .
METHODS	The primary end point of the study was represented by a PCR adjusted adequate clinical and parasitological response ( ACPR ) at day 28 .
METHODS	Secondary end points included : ( i ) a ACPR at days 35 and 42 , ( ii ) a parasite and fever clearance time , ( iii ) ACTs safety and tolerability .
METHODS	The 2003 WHO 's protocol for antimalarial drug evaluation was used to assess each outcome .
RESULTS	Overall , 534 patients were randomized selected to receive , either ASAQ ( n = 180 ) , AL ( n = 178 ) or DHAPQ ( n = 176 ) .
RESULTS	The PCR adjusted ACPR at day 28 was 99.41 % for the group ASAQ , while that was 100 % in the AL and DHAPQ groups ( p = 0.37 ) .
RESULTS	The therapeutic efficacy was evaluated at 99.37 % in the ASAQ arm versus 100 % in AL and DHAPQ arm at day 35 ( p = 0.37 ) .
RESULTS	At day 42 , the ACPR was 99.27 % in the ASAQ group versus 100 % for both AL and DHAPQ groups , ( p = 0.36 ) .
RESULTS	No serious adverse event was noted during the study period .
RESULTS	Also a similar safety profile was noted in the 3 study groups .
CONCLUSIONS	In the context of scaling up of ACTs in Senegal , ASAQ , AL and DHAPQ are highly effective and safe antimalarial drugs .
CONCLUSIONS	However , it 's remains important to continue to monitor their efficacy .
BACKGROUND	PACTR 201305000552290 .

###24818207
OBJECTIVE	To assess the response of soft tissues around two different abutment designs in healed sites in the esthetic zone .
METHODS	Twenty-six subjects received two endosseous implants in healed , bilateral implant sites in the esthetic zone in the maxilla or the mandible .
METHODS	After 17 to 19 weeks and left/right randomization , the implants were restored with either a conventional ( control ) or curved ( experimental ) titanium abutment and a provisional crown .
METHODS	Eight weeks after abutment placement , definitive crowns were cemented ( T0 ) .
METHODS	Soft tissue development was assessed based on peri-implant bone loss , Pink Esthetic Score ( PES ) , and probing depths immediately after placement of the definitive crown and after 1 year ( T12 ) and compared between sites .
METHODS	Possible confounding variables ( abutment angle , plaque presence , gingival bleeding , width of attached mucosa ) were also documented at T0 and T12 .
RESULTS	The mean peri-implant marginal bone loss from T0 to T12 was 0.00 0.37 mm in the experimental group and 0.12 0.27 mm in the control group .
RESULTS	Differences were not statistically significant ( P = .25 ) .
RESULTS	At T12 , the curved abutment scored a mean PES of 10 2.3 and the straight abutment scored 9.7 2.3 .
RESULTS	The difference was not significant ( P = .46 ) ) .
RESULTS	Probing depths were also not significantly different between the two groups ( P = .85 ) .
RESULTS	Correlation and regression analysis showed no hints of predictive behavior for the possible confounding variables .
CONCLUSIONS	A titanium abutment with a circumferential curved design is of no additional benefit to soft tissue development and preservation of marginal bone compared to a conventional straight abutment design for the restoration of single-tooth implants in the esthetic zone .

###24277399
OBJECTIVE	To investigate the effect of postoperative early oral feeding on humoral immune function and clinical outcome in colorectal cancer patients .
METHODS	Seventy patients with colorectal carcinoma requiring elective colorectal resection were prospectively enrolled and randomized into two groups : early oral feeding group ( n = 35 ) and conventional oral feeding group ( n = 35 ) .
METHODS	The patients in early oral feeding group were started on oral feeding within 12 hours after operation , while patients in conventional group were started on oral feeding after the postoperative first passage of flatus .
METHODS	Postoperative parameters of clinic and humeral immune function were compared between two groups .
RESULTS	Sixty-two patients eventually completed the study , including 32 cases in early oral feeding group and 30 cases in conventional oral feeding group .
RESULTS	The average time to first passage of flatus [ ( 21 ) d vs. ( 42 ) d , P < 0.01 ] , the first passage of stool [ ( 3.81.6 ) d vs. ( 6.42.5 ) d , P < 0.01 ] , resumption of regular diet [ ( 42 ) d vs. ( 8.22.2 ) d , P < 0.01 ] and the postoperative hospital stay [ ( 61 ) d vs. ( 11.73.8 ) d , P < 0.01 ] were significantly shorter in early oral feeding group as compared to conventional oral feeding group .
RESULTS	Significantly faster recovery of postoperative humoral immunity was found .
RESULTS	Plasma levels of globulin [ ( 24.12.4 ) g/L vs. ( 22.13.3 ) g/L , P < 0.05 ] , immunoglobulin G [ ( 10.82.4 ) g/L vs. ( 8.72.1 ) g/L , P < 0.01 ] and complement 4 [ ( 0.240.09 ) g/L vs. ( 0.170.05 ) g/L , P < 0.05 ] on postoperative day 3 were higher in early oral feeding group as compared to conventional oral feeding group .
CONCLUSIONS	Application of postoperative early oral feeding in patients undergoing elective colorectal resection is safe and effective , which can lead to faster recovery of postoperative humoral immune function and bowel function , and shorter postoperative hospital stay .

###24856792
BACKGROUND	It is known that static stretching is an appropriate means of increasing the range of motion , but information in the literature about the mechanical adaptation of the muscle-tendon unit is scarce .
BACKGROUND	Therefore , the purpose of this study was to investigate the influence of a six-week static stretching training program on the structural and functional parameters of the human gastrocnemius medialis muscle and the Achilles tendon .
METHODS	A total of 49 volunteers were randomly assigned into static stretching and control groups .
METHODS	Before and following the stretching intervention , we determined the maximum dorsiflexion range of motion with the corresponding fascicle length and pennation angle .
METHODS	Passive resistive torque and maximum voluntary contraction were measured with a dynamometer .
METHODS	Muscle-tendon junction displacement allowed us to determine the length changes in tendon and muscle , and hence to calculate stiffness .
METHODS	Fascicle length , pennation angle , and muscle tendon junction displacement were measured with ultrasound .
RESULTS	Mean range of motion increased significantly from 30.9 ( 5.3 ) to 36.3 ( 6.1 ) in the intervention group , but other functional ( passive resistive torque , maximum voluntary contraction ) and structural ( fascicle length , pennation angle , muscle stiffness , tendon stiffness ) parameters were unaltered .
CONCLUSIONS	The increased range of motion could not be explained by the structural changes in the muscle-tendon unit , and was likely due to increased stretch tolerance possibly due to adaptations of nociceptive nerve endings .

###25399618
BACKGROUND	Melasma is a dermatosis with significant repercussions on patients ' quality of life , and there is currently no standard treatment .
BACKGROUND	Hydroquinone is deemed the treatment of choice , but its safety has been questioned in certain cases .
OBJECTIVE	To determine the efficacy and safety of a new combination of retinoids in the improvement of melasma .
METHODS	Prospective , double-blind , vehicle-controlled , and randomized study in 30 patients with melasma .
METHODS	The product was applied on one side of the face and the vehicle on the other , twice daily during 3months .
METHODS	Standardized photographs were taken using RBX technology on the three visits ( basal , at one and a half months and at 3months ) .
METHODS	The main variable to determine the efficacy was the improvement of the hemifacial Melasma Area Severity Index ( MASI ) .
METHODS	Other variables were determined such as improvement perceived by the investigator , improvement perceived by the patient , impact on quality of life or side effects .
RESULTS	The MASI improvement at 3months of treatment was significant on the treated side vs. the vehicle side , reaching an improvement of 70 % , which is comparable to the percentage of improvement described with hydroquinone .
RESULTS	No notable side effects were detected , in spite of a significant percentage of patients included in the study citing a history that could be compatible with sensitive skin .
CONCLUSIONS	This new combination of retinoids and depigmenting agents proved to be effective and safe in the treatment of melasma .

###25504030
OBJECTIVE	A common variant rs236918 in the PCSK7 gene has the strongest association with iron homeostasis and is related to insulin resistance .
OBJECTIVE	Dietary carbohydrate ( CHO ) modulates the genetic effect on insulin resistance .
OBJECTIVE	We examined whether 2-year weight-loss diets modify the effect of PCSK7 genetic variants on changes in fasting insulin levels and insulin resistance in a randomized , controlled trial .
METHODS	Data were analyzed in the Preventing Overweight Using Novel Dietary Strategies ( POUNDS LOST ) trial , which is a randomized , controlled 2-year weight-loss trial using diets that differed in macronutrient proportions .
METHODS	PCSK7 rs236918 was genotyped in 730 overweight or obese adults ( 80 % whites ) in this trial .
METHODS	We assessed the progression in fasting insulin and glucose levels , and insulin resistance by genotypes .
RESULTS	During the 6-month weight-loss phase , the PCSK7 rs236918 G allele was significantly associated with greater decreases in fasting insulin levels in the high-dietary CHO group ( P for interaction = 0.04 ) , while the interaction for changes in HOMA-insulin resistance ( HOMA-IR ) ( P for interaction = 0.06 ) did not reach significant levels in white subjects .
RESULTS	The G allele was significantly associated with a greater decrease in fasting insulin levels and HOMA-IR in response to high dietary CHO levels ( P = 0.02 and P = 0.03 , respectively ) .
RESULTS	From 6 months to 2 years ( weight-regain phase ) , the interactions became attenuated due to the regaining of weight ( P for interactions = 0.08 and 0.06 , respectively ) .
RESULTS	In addition , we observed similar and even stronger results in the whole-study samples from the trial .
CONCLUSIONS	Our data suggest that PCSK7 genotypes may interact with dietary CHO intake on changes in insulin sensitivity in the white Americans .

###24797544
OBJECTIVE	To assess the use of a hydrogel ocular bandage ( HOB ) on clear corneal incisions in phacoemulsification cataract surgery and determine whether HOB reduces ocular surface contaminants ingress after routine surgery .
METHODS	In this prospective randomized controlled study , thirty eyes of patients undergoing uneventful phacoemulsification were recruited consecutively and randomly assigned to have a HOB applied to the corneal incision at the end of the surgery or not .
METHODS	At the end of the surgery , trypan blue ( TRB ) was instilled on the ocular surface , aqueous fluid was aspirated from the anterior chamber ( AC ) and its optical density was measured using ultraviolet spectrophotometry .
METHODS	The corneal incisions were examined postoperatively using anterior segment optical coherence tomography .
METHODS	Main outcome measures were concentration of TRB in the AC , corneal incision architecture , intraocular pressure ( IOP ) and Seidel test .
RESULTS	All incisions were Seidel negative .
RESULTS	The mean IOP in the immediate postoperative period was 18.1 5.48 mmHg for the intervention group and 16.9 5.7 mmHg for the control group ( p > 0.05 ) .
RESULTS	No architectural differences of the incisions between the two groups were noted .
RESULTS	The total mean length of the three-step corneal incisions in the two groups was 2261.2 96.92 m and 2263 119.75 m , respectively ( p > 0.05 ) .
RESULTS	No trace of TRB was detected in any of the samples .
CONCLUSIONS	Proper surgical wound construction without the use of a HOB is efficient in preventing the ingress of fluid through the main corneal incision postoperatively .

###24928479
BACKGROUND	Concurrent administration of dopamine and serotonin reuptake inhibitors reduces cocaine self-administration in monkeys .
BACKGROUND	Consonant with this , clinical trials assessing modafinil and selective serotonin reuptake inhibitors alone show some efficacy as potential pharmacotherapies for cocaine dependence .
BACKGROUND	We hypothesized that combining modafinil with escitalopram would attenuate the euphoric effects of cocaine to a greater degree than modafinil alone .
METHODS	In a randomized , double blind , parallel groups design participants received either placebo ( 0mg/day ; n = 16 ) , modafinil ( 200mg/day ; n = 16 ) , escitalopram ( 20mg/day ; n = 17 ) , or modafinil + escitalopram ( 200 +20 mg/day ; n = 15 ) for 5 days .
METHODS	On day 5 , during separate sessions participants received an intravenous sample of cocaine ( 0 or 20mg ; randomized ) and five $ 1 bills .
METHODS	Participants rated the subjective effects of the infusions and subsequently made choices to either return $ 1 and receive another infusion or keep $ 1 and receive no infusion .
RESULTS	Compared to saline , cocaine ( 20mg ) significantly ( p0 .008 ) increased most ratings , including `` good effects '' , `` stimulated '' , and `` high '' .
RESULTS	Relative to placebo , modafinil significantly ( p0 .007 ) attenuated subject-rated increases of `` any drug effect '' , `` high '' , `` good effects '' , and `` stimulated '' produced by cocaine .
RESULTS	Compared to saline , participants chose cocaine infusions significantly more ; however , no treatment significantly reduced choices for cocaine infusions .
RESULTS	Escitalopram did not enhance the efficacy of modafinil to reduce any measure .
CONCLUSIONS	Modafinil attenuated many positive subjective effects produced by cocaine ; however , escitalopram combined with modafinil did not enhance the efficacy of modafinil to reduce cocaine effects .

###24491000
OBJECTIVE	To compare polypropylene suture and skin staples for securing mesh in Lichtenstein inguinal hernioplasty in terms of mean operating time and postoperative pain .
METHODS	Randomized clinical trial .
METHODS	Surgical Ward , Combined Military Hospital , Kharian , from August 2011 to February 2012 .
METHODS	All individuals fulfilling inclusion criteria underwent elective Lichtenstein inguinal hernioplasty as admitted patients , under spinal anaesthesia and with aseptic measures .
METHODS	In group 1 , during the operation , mesh fixation was done with 2/0 polypropylene suture and skin was closed with subcuticular 2/0 polypropylene suture whereas in group 2 , the anchorage of mesh was done with skin staples and skin was closed with staples from the same stapler .
METHODS	Mean operative time and postoperative pain , assessed on a visual analog score , were compared between the groups .
RESULTS	The overall postoperative pain was lower ( p = 0.026 ) when staples were used to anchor mesh .
RESULTS	Moreover , operative time was also lower ( 37.42 2.69 minutes ) in staple group versus ( 42.44 2.55 minutes in polypropylene group ) .
CONCLUSIONS	Mean operating time and postoperative pain is less in securing mesh with skin staples as compared to polypropylene suture in Lichtenstein inguinal hernioplasty .

###24630510
OBJECTIVE	Endoscopic sphincterotomy ( ES ) is one of the most important advances in the treatment of common bile duct ( CBD ) stones .
OBJECTIVE	However , the use of ES to remove CBD stones in high-risk patients without cholecystectomy is still debatable .
OBJECTIVE	The aim of this study was to compare the efficacy of a wait-and-see policy versus cholecystectomy after ES for CBD stones in high-risk patients with co-existing cholelithiasis .
METHODS	A total of 162 patients after undergoing ES with the clearance of CBD stones were randomised after informed consent to cholecystectomy or conservative management of their gallbladder stones .
RESULTS	The results indicated that cholecystectomy after ES for CBD stones significantly reduced the biliary complications in high-risk patients .
CONCLUSIONS	Every patient who has both CBD stones and gallstones with significant co-morbid illnesses , after clearance of CBD stones by ES , should undergo early cholecystectomy .

###24484547
BACKGROUND	Parenterally administered ascorbic acid modulates sepsis-induced inflammation and coagulation in experimental animal models .
BACKGROUND	The objective of this randomized , double-blind , placebo-controlled , phase I trial was to determine the safety of intravenously infused ascorbic acid in patients with severe sepsis .
METHODS	Twenty-four patients with severe sepsis in the medical intensive care unit were randomized 1:1:1 to receive intravenous infusions every six hours for four days of ascorbic acid : Lo-AscA ( 50 mg/kg/24 h , n = 8 ) , or Hi-AscA ( 200 mg/kg/24 h , n = 8 ) , or Placebo ( 5 % dextrose/water , n = 8 ) .
METHODS	The primary end points were ascorbic acid safety and tolerability , assessed as treatment-related adverse-event frequency and severity .
METHODS	Patients were monitored for worsened arterial hypotension , tachycardia , hypernatremia , and nausea or vomiting .
METHODS	In addition Sequential Organ Failure Assessment ( SOFA ) scores and plasma levels of ascorbic acid , C-reactive protein , procalcitonin , and thrombomodulin were monitored .
RESULTS	Mean plasma ascorbic acid levels at entry for the entire cohort were 17.9 2.4 M ( normal range 50-70 M ) .
RESULTS	Ascorbic acid infusion rapidly and significantly increased plasma ascorbic acid levels .
RESULTS	No adverse safety events were observed in ascorbic acid-infused patients .
RESULTS	Patients receiving ascorbic acid exhibited prompt reductions in SOFA scores while placebo patients exhibited no such reduction .
RESULTS	Ascorbic acid significantly reduced the proinflammatory biomarkers C-reactive protein and procalcitonin .
RESULTS	Unlike placebo patients , thrombomodulin in ascorbic acid infused patients exhibited no significant rise , suggesting attenuation of vascular endothelial injury .
CONCLUSIONS	Intravenous ascorbic acid infusion was safe and well tolerated in this study and may positively impact the extent of multiple organ failure and biomarkers of inflammation and endothelial injury .
BACKGROUND	ClinicalTrials.gov identifier NCT01434121 .

###24464746
OBJECTIVE	We sought to test the hypothesis that plasma galectin 3 ( Gal-3 ) is positively associated with the risk of heart failure ( HF ) in male subjects .
RESULTS	While Gal-3 has been reported as prognostic factor in HF patients , limited data are available on the role of Gal-3 in the development of HF .
RESULTS	We used a prospective nested-case control study ( n = 462 cases and 462 controls ) within the Physicians ' Health Study for current analyses .
RESULTS	For each case of HF , we randomly selected one control among subjects that were alive and free of HF at the time of index case occurrence and matched on age , race , and time of blood collection .
RESULTS	Gal-3 was measured using ELISA and we used conditional logistic regression to compute adjusted odds ratios .
RESULTS	Mean age at baseline was 58.3 y and median log-Gal-3 was 1.50 ( IQR : 1.20-1 .73 ) ng/ml .
RESULTS	Cubic splines suggested a non-linear relation between Gal-3 and HF .
RESULTS	Odds ratios ( 95 % CI ) for HF were 1.0 ( ref ) , 0.89 ( 0.58-1 .38 ) , 1.08 ( 0.71-1 .67 ) , and 1.57 ( 1.03-2 .39 ) across consecutive quartiles of Gal-3 after adjustment for body mass index , diabetes , atrial fibrillation , hypertension , C-reactive protein , alcohol , smoking , and exercise .
RESULTS	The Gal-3-HF relation was seen for HF with and without antecedent coronary heart disease .
CONCLUSIONS	Our data are consistent with a positive non-linear association between Gal-3 and HF risk in male subjects .

###25047090
BACKGROUND	Acetaminophen administration for more than 4 days causes aminotransferase elevation in some subjects .
BACKGROUND	The objective of this randomized , placebo-controlled trial is to describe the course of alanine aminotransferase ( ALT ) elevation in subjects administered 4 g/day of acetaminophen for at least 16 days .
METHODS	A randomized , placebo controlled trial of acetaminophen ( 4 g/day ) vs placebo .
METHODS	Subjects were healthy volunteers with normal liver enzymes .
METHODS	The primary outcome was the course of ALT during acetaminophen administration .
METHODS	All subjects were treated for a minimum of 16 days .
METHODS	Subjects with ALT elevation at day 16 were continued on treatment until these elevations resolved up to a maximum of 40 days .
METHODS	Subjects were also evaluated for elevation of INR or serum bilirubin as evidence of hepatic dysfunction .
RESULTS	157/205 ( 77 % ) completed acetaminophen subjects had no ALT elevation or transient elevations that resolved by day 16 .
RESULTS	Of the 48 subjects who had ALT elevations at study day 16 , 47 continued on acetaminophen and had resolution by study day 40 .
RESULTS	One acetaminophen subject did not have resolution by study day 40 , and the course of aminotransferase elevation suggests an alternative cause .
RESULTS	One placebo subject had an ALT elevation at day 16 that resolved by day 22 .
RESULTS	The highest observed ALT among all acetaminophen subjects was 191 IU/L .
RESULTS	The mean ALT at day 16 was 4.4 IU/L higher for the acetaminophen than for the placebo group .
RESULTS	No subject developed liver dysfunction .
CONCLUSIONS	A minority of subjects treated with 4 g/day of acetaminophen for 16 days will have low-grade aminotransferase elevations that are not accompanied by liver dysfunction and resolve if administration is continued .
BACKGROUND	Clintrials.gov NCT00743093 registered August 26 , 2008 .

###26068323
OBJECTIVE	The aim of the present study was to evaluate the effect of oral caffeine ingestion during repeated sets of resistance .
METHODS	Fourteen moderately resistance-trained men ( 20.9 0.36 years and 77.62 2.07 kg of body weight ) ingested a dose of caffeine ( 5 mg.kg-1 ) or placebo prior to 3 sets of bench press and 3 sets of leg press exercises , respectively .
METHODS	The study used a double-blind , counterbalanced , crossover design .
METHODS	Repetitions completed and total weight lifted were recorded in each set .
METHODS	Readiness to invest in both physical ( RTIPE ) and mental ( RTIME ) effort were assessed prior each set , and rating of perceived exertion ( RPE ) was recorded after each set .
METHODS	Rest and peak heart rates were determined via telemetry .
RESULTS	Caffeine ingestion result in increased number of repetitions to failure in bench press ( F [ 1,13 ] = 6.16 , P = 0.027 ) and leg press ( F [ 1,13 ] = 9.33 , P = 0.009 ) compared to placebo .
RESULTS	The sum of repetitions performed in the 3 sets was 11.60 % higher in bench press ( 26.86 1.74 ; caffeine : 30.00 1.87 ; P = 0.027 ) and 19.10 % in leg press ( placebo : 40.0 4.22 ; caffeine : 47.64 4.69 ; P = 0.009 ) .
RESULTS	Also , RTIME was increased in the caffeine condition both in bench press ( F [ 1,13 ] = 7.02 , P = 0.02 ) and in leg press ( F [ 1,13 ] = 5.41 , P = 0.03 ) .
RESULTS	There were no differences in RPE , RTIPE and HR ( P > 0.05 ) across conditions .
CONCLUSIONS	Acute caffeine ingestion can improve performance in repeated sets to failure and increase RTIME in resistance-trained men .

###24429155
BACKGROUND	Little evidence is available for the effect of nebulised magnesium sulphate ( MgSO ( 4 ) ) in acute asthma in children .
BACKGROUND	We assessed the effect of MgSO ( 4 ) treatment in children with severe acute asthma .
METHODS	In this randomised placebo-controlled , multi-centre , parallel trial , we enrolled children ( aged 2-16 years ) with severe acute asthma who did not respond to standard inhaled treatment from 30 hospitals in the UK .
METHODS	Children were randomly allocated ( 1:1 ) to receive nebulised salbutamol and ipratropium bromide with either 25 mL of isotonic MgSO ( 4 ) ( 250 mmol/L ; 151 mg per dose ; MgSO ( 4 ) group ) or 25 mL of isotonic saline ( placebo group ) on three occasions at 20-min intervals .
METHODS	Randomisation was done with a computer-generated randomisation sequence , with random block sizes of two to four .
METHODS	Both patients and researchers were masked to treatment allocation .
METHODS	The primary outcome measure was the Yung Asthma Severity Score ( ASS ) at 60 min post-randomisation .
METHODS	We used a statistical significance level of p < 005 for a between-group difference , but regarded a between-group difference in ASS of 05 as the minimal clinically significant treatment effect .
METHODS	Analysis was done by intention to treat .
METHODS	This trial is registered with controlled-trials .
METHODS	com , number ISRCTN81456894 .
RESULTS	Between Jan 3 , 2009 , and March 20 , 2011 , we recruited and randomly assigned 508 children to treatment : 252 to MgSO ( 4 ) and 256 to placebo .
RESULTS	Mean ASS at 60 min was lower in the MgSO ( 4 ) group ( 472 [ SD 137 ] ) than it was in the placebo group ( 495 [ SD 140 ] ; adjusted difference -025 , 95 % CI -048 to -002 ; p = 003 ) .
RESULTS	This difference , however , was not clinically significant .
RESULTS	The clinical effect was larger in children with more severe asthma exacerbation ( p = 003 ) and those with symptoms present for less than 6 h ( p = 0049 ) .
RESULTS	We detected no difference in the occurrence of adverse events between groups .
CONCLUSIONS	Overall , nebulised isotonic MgSO ( 4 ) , given as an adjuvant to standard treatment , did not show a clinically significant improvement in mean ASS in children with acute severe asthma .
CONCLUSIONS	However , the greatest clinical response was seen in children with more severe attacks ( SaO ( 2 ) < 92 % ) at presentation and those with preceding symptoms lasting less than 6 h.
BACKGROUND	National Institute for Health Research Health Technology Assessment Programme .

###25126031
OBJECTIVE	To compare the efficacy and patient comfort of a new mode of minute ventilation-targeted adaptive servoventilation ( ASVAuto ) with auto-titrating expiratory positive airway pressure ( EPAP ) versus bilevel with back-up respiratory rate ( bilevel-ST ) in patients with central sleep apnea ( CSA ) associated with chronic use of opioid medications .
METHODS	Prospective , randomized , crossover polysomnography ( PSG ) study .
METHODS	Eighteen consecutive patients ( age 18 years ) who had been receiving opioid therapy ( 6 months ) , and had sleep disordered breathing with CSA ( central apnea index [ CAI ] 5 ) diagnosed during an overnight sleep study or positive airway pressure ( PAP ) titration were enrolled to undergo 2 PSG studies-one with ASVAuto and one with bilevel-ST .
METHODS	Patients completed 2 questionnaires after each PSG ; Morning After Patient Satisfaction Questionnaire and PAP Comfort Questionnaire .
RESULTS	Patients had a mean age of 52.9 15.3 years .
RESULTS	PSG prior to randomization showed an apnea hypopnea index ( AHI ) of 50.3 22.2 and CAI of 13.0 18.7 .
RESULTS	Titration with ASVAuto versus bilevel-ST showed that there were significant differences with respect to AHI and CAI .
RESULTS	The AHI and CAI were significantly lower on ASVAuto than bilevel-ST ( 2.5 3.5 versus 16.3 20.9 [ p = 0.0005 ] , and 0.4 0.8 versus 9.4 18.8 [ p = 0.0002 ] , respectively ) .
RESULTS	Respiratory parameters were normalized in 83.3 % of patients on ASVAuto versus 33.3 % on bilevel-ST .
RESULTS	Patients felt more awake and alert on ASVAuto than bilevel-ST based on scores from Morning After Patient Satisfaction Questionnaire ( p = 0.0337 ) .
CONCLUSIONS	The ASVAuto was significantly more effective than bilevel-ST for the treatment of CSA associated with chronic opioid use .

###24903469
BACKGROUND	Dementia affects over 4 million people in the US and is frequently unrecognized and underdiagnosed in primary care .
BACKGROUND	Routine dementia screening in primary care is not recommended by the US Preventive Services Task Force due to lack of empirical data on the benefits and harms of screening .
BACKGROUND	This trial seeks to fill this gap and contribute information about the benefits , harms , and costs of routine screening for dementia in primary care .
METHODS	Single-blinded , parallel , randomized controlled clinical trial with 1:1 allocation .
METHODS	A total of 4,000 individuals aged 65 years without a diagnosis of dementia , cognitive impairment , or serious mental illness receiving care at primary care practices within two cities in Indiana .
METHODS	Subjects will be randomized to either i ) screening for dementia using the Memory Impairment Screen Telephone version or ii ) no screening for dementia .
METHODS	Subjects who screen positive for dementia will be referred to the local Aging Brain Care program that delivers an evidence-based collaborative care model for dementia and depression .
METHODS	Research assistants will administer the 15-item Health Utility Index , Patient Health Questionnaire , Generalized Anxiety Disorder Scale , and Medical Outcomes Study at baseline , 1 , 6 , and 12 months .
METHODS	Information about advanced care planning will be collected at baseline and 12 months .
METHODS	All enrollees ' medical records will be reviewed to collect data on health care utilization and costs .
CONCLUSIONS	We have two primary hypotheses ; first , in comparison to non-screened subjects , those who are screened and referred to a dementia collaborative care program will have a higher health-related quality of life as measured by the Health Utility Index at 12 months post-screening .
CONCLUSIONS	Second , in comparison to non-screened subjects , those who are screened and referred to a dementia collaborative care program will not have higher depression or anxiety at one month post-screening as measured by the Patient Health Questionnaire and Generalized Anxiety Disorder Scale scales .
CONCLUSIONS	Our secondary hypothesis is that screened subjects will have an Incremental Cost-Effectiveness Ratio below the maximum acceptable threshold of $ 60,000 per quality adjusted life year saved at 12 months .
BACKGROUND	Ongoing ; registered on September 19 , 2012 .
BACKGROUND	ClinicalTrials.gov Identifier : 2012 NCT01699503 .

###25756412
OBJECTIVE	To evaluate the differences in extubation times in a group of cardiac surgical patients who were anesthetized and sedated with either IV propofol or inhaled volatile anesthetic agents .
METHODS	This was a prospective randomized controlled trial performed between September 2009 and August 2011 .
METHODS	Cardiovascular ICU within a tertiary referral university-affiliated teaching hospital .
METHODS	One hundred forty-one patients undergoing coronary artery bypass graft surgery with normal or mildly reduced left ventricular systolic function .
METHODS	Participants were randomly assigned to receive anesthesia and postoperative sedation using IV propofol ( n = 74 ) or inhaled volatile ( isoflurane or sevoflurane ) anesthetic agent ( n = 67 ) .
RESULTS	Patients sedated using inhaled volatile agent displayed faster readiness to extubation time at 135 minutes ( 95-200 min ) compared with those receiving IV propofol at 215 minutes ( 150-280 min ) ( p < 0.001 ) .
RESULTS	Extubation times were faster within the volatile group at 182 minutes ( 140-255 min ) in comparison with propofol group at 291 minutes ( 210-420 min ) ( p < 0.001 ) .
RESULTS	The volatile group showed a higher prevalence of vasodilatation with hypotension and higher cardiac outputs necessitating greater use of vasoconstrictors .
RESULTS	There was no difference in postoperative pain scores , opioid consumption , sedation score , ICU or hospital length of stay , or patient mortality .
CONCLUSIONS	Inhaled volatile anesthesia and sedation facilitates faster extubation times in comparison with IV propofol for patient undergoing coronary artery bypass graft surgery .

###24974996
BACKGROUND	Intraoral elastics are commonly used in orthodontics and require regular changing to be effective .
BACKGROUND	Unfortunately , poor compliance with elastics is often encountered , especially in adolescents .
BACKGROUND	Intention for an action and its implementation can be improved using `` if-then '' plans that spell out when , where , and how a set goal , such as elastic wear , can be put into action .
BACKGROUND	Our aim was to determine the effect of if-then plans on compliance with elastics .
METHODS	To identify common barriers to compliance with recommendations concerning elastic wear , semistructured interviews were carried out with 14 adolescent orthodontic patients wearing intraoral elastics full time .
METHODS	Emerging themes were used to develop if-then plans to improve compliance with elastic wear .
METHODS	A prospective pilot study assessed the effectiveness of if-then planning aimed at overcoming the identified barriers on compliance with elastic wear .
METHODS	Twelve participants were randomized equally into study and control groups ; the study group received information about if-then planning .
METHODS	The participants were asked to collect used elastics , and counts of these were used to assess compliance .
RESULTS	A wide range of motivational and volitional factors were described by the interviewed participants , including the perceived benefits of elastics , cues to remember , pain , eating , social situations , sports , loss of elastics , and breakages .
RESULTS	Compliance with elastic wear was highly variable among patients .
RESULTS	The study group returned more used elastics , suggesting increased compliance , but the difference was not significant .
CONCLUSIONS	The use of if-then plans might improve compliance with elastic wear when compared with routine clinical instructions .

###26091325
BACKGROUND	Fourteen percent ( 43.1 million ) of the population in the United States was 65 years and older in 2012 .
BACKGROUND	This population is projected to reach 20 % ( 88.5 million ) by 2050 .
BACKGROUND	Older adults accounted for 17 % of all traffic fatalities and 9 % of all vehicle occupant injuries in 2012 .
BACKGROUND	We explored the effectiveness of three interventions to help older adults assess their current driving behaviors at a Level 1 trauma center .
METHODS	During 2010 to 2012 , 1,216 inpatients 70 years and older admitted for surgical and medical services were screened for eligibility , and 120 were enrolled .
METHODS	Participants completed a driving assessment and preintervention questionnaires and were subsequently randomized to one of the following interventions : ( 1 ) brief negotiated interview plus an educational kit by the American Automobile Association about older driving plus an accompanying list of Web-based resources for older adult drivers ; ( 2 ) American Automobile Association document and a list of Web-based resources ; ( 3 ) online referral sheet of the list of Web-based resources only .
METHODS	A 3-month postintervention follow-up questionnaire was administered over the telephone to measure changes in ( 1 ) driving-related knowledge , attitudes , and beliefs as well as ( 2 ) driving-related behaviors and intended behaviors .
RESULTS	A total of 113 randomized patients were included in the analysis .
RESULTS	The mean ( SD ) age was 76.8 ( 5.23 ) years ; majority of patients were white ( 64 % ) , followed by black African American ( 33 % ) ; and 51 % were males and 49 % were females .
RESULTS	Multivariate analysis showed that older adults ' driving knowledge , attitudes , and beliefs ( p < 0.0001 , R = 0.37 ) as well as behaviors and intentions ( p < 0.0001 , R = 0.27 ) toward driving were positively correlated , controlling for other predictors in the model .
RESULTS	Intervention assignment did not affect changes in outcomes , although outcomes improved across experimental conditions .
CONCLUSIONS	Our pilot study suggests that older adults are likely to make changes in their driving behavior on the basis of minimal hospital-based intervention .

###26028347
BACKGROUND	Extending palliative care to those with advanced non-malignant disease is advocated , but the implications in specific conditions are poorly understood .
OBJECTIVE	We piloted a novel nurse-led intervention , HELPing older people with very severe chronic obstructive pulmonary disease ( HELP-COPD ) , undertaken 4 weeks after discharge from hospital , which sought to identify and address the holistic care needs of people with severe COPD .
METHODS	This 6-month mixed-method feasibility pilot trial randomised ( ratio 3:1 ) patients to HELP-COPD or usual care .
METHODS	We assessed the feasibility of using validated questionnaires as outcome measures and analysed the needs/actions recorded in the HELP-COPD records .
METHODS	Semi-structured interviews with a purposive sample of patients , carers and professionals explored the perceptions of HELP-COPD .
METHODS	Verbatim transcriptions and field notes were analysed using Normalisation Process Theory as a framework .
RESULTS	We randomised 32 patients ( 24 to HELP-COPD ) ; 19 completed the study ( death = 3 , ill-health = 4 , declined = 6 ) .
RESULTS	The HELP-COPD record noted a mean of 1.6 actions/assessment , mostly provision of information or self-help actions : only five referrals were made .
RESULTS	Most patients were positive about HELP-COPD , discussing their concerns and coping strategies in all domains , but the questionnaires were burdensome for some patients .
RESULTS	Adaptation to their slowly progressive disability and a strong preference to rely on family support was reflected in limited acceptance of formal services .
RESULTS	Professionals perceived HELP-COPD as addressing an important aspect of care , although timing overlapped with discharge planning .
CONCLUSIONS	The HELP-COPD intervention was well received by patients and the concept resonated with professionals , although delivery post discharge overlapped with existing services .
CONCLUSIONS	Integration of brief holistic care assessments in the routine primary care management of COPD may be more appropriate .

###24508899
OBJECTIVE	The increasing prevalence of resistant bacteria such as fluoroquinolone-resistant or extended-spectrum - lactamase-producing strains in pathogens causing acute uncomplicated cystitis has been of concern in Japan .
OBJECTIVE	Faropenem sodium is a penem antimicrobial that demonstrates a wide antimicrobial spectrum against both aerobic and anaerobic bacteria .
OBJECTIVE	It is stable against a number of - lactamases .
METHODS	We compared 3 and 7 day administration regimens of faropenem in a multicentre , randomized , open-label , controlled study .
RESULTS	In total , 200 female patients with cystitis were enrolled and randomized into 3 day ( N = 97 ) or 7 day ( N = 103 ) treatment groups .
RESULTS	At the first visit , 161 bacterial strains were isolated from 154 participants , and Escherichia coli accounted for 73.9 % ( 119/161 ) of bacterial strains .
RESULTS	At 5-9 days after the completion of treatment , 73 and 81 patients from the 3 day and 7 day groups , respectively , were evaluated by intention-to-treat analysis ; the microbiological efficacies were 58.9 % eradication ( 43/73 ) , 20.5 % persistence ( 15/73 ) and 8.2 % replaced ( 6/73 ) , and 66.7 % eradication ( 54/81 ) , 6.2 % persistence ( 5/81 ) and 7.4 % replaced ( 6/81 ) , respectively ( P = 0.048 ) .
RESULTS	The clinical efficacies were 76.7 % ( 56/73 ) and 80.2 % ( 65/81 ) , respectively ( P = 0.695 ) .
RESULTS	Adverse events due to faropenem were reported in 9.5 % of participants ( 19/200 ) , and the most common adverse event was diarrhoea .
CONCLUSIONS	The 7 day regimen showed a superior rate of microbiological response .
CONCLUSIONS	E. coli strains were in general susceptible to faropenem , including fluoroquinolone - and cephalosporin-resistant strains .

###24694207
BACKGROUND	Teaching people with epilepsy to identify and manage seizure triggers , implement strategies to remember to take antiepileptic drugs , implement precautions to minimize risks during seizures , tell others what to do during a seizure and learn what to do during recovery may lead to better self-management .
BACKGROUND	No teaching programme exists for adults with epilepsy in the United Kingdom although a number of surveys have shown patients want more information .
METHODS	This is a multicentre , pragmatic , parallel group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of a two-day Self-Management education for epILEpsy ( SMILE ( UK ) ) , which was originally developed in Germany ( MOSES ) .
METHODS	Four hundred and twenty eight adult patients who attended specialist epilepsy outpatient clinics at 15 NHS participating sites in the previous 12 months , and who fulfil other eligibility criteria will be randomised to receive the intervention ( SMILE ( UK ) course with treatment as usual - TAU ) or to have TAU only ( control ) .
METHODS	The primary outcome is the effect on patient reported quality of life ( QoL ) .
METHODS	Secondary outcomes are seizure frequency and psychological distress ( anxiety and depression ) , perceived impact of epilepsy , adherence to medication , management of adverse effects from medication , and improved self-efficacy in management ( mastery/control ) of epilepsy.Within the trial there will be a nested qualitative study to explore users ' views of the intervention , including barriers to participation and the perceived benefits of the intervention .
METHODS	The cost-effectiveness of the intervention will also be assessed .
CONCLUSIONS	This study will provide quantitative and qualitative evidence of the impact of a structured self management programme on quality of life and other aspects of clinical and cost effectiveness in adults with poorly controlled epilepsy .
BACKGROUND	Current Controlled Trials : ISRCTN57937389 .

###25143025
BACKGROUND	Depression related to interferon-alpha ( IFN - ) is common , may reduce adherence , and can be treatment limiting .
BACKGROUND	HIV-HCV coinfected persons experience lower sustained virologic response rates and commonly have psychiatric comorbidities , thus they may benefit from prevention of depression .
OBJECTIVE	The aim of the study was to determine whether prophylactic citalopram can increase HCV treatment adherence and reduce the incidence of moderate depression in HIV-HCV coinfected patients initiating PEG-IFN - / ribavirin therapy .
METHODS	This was an investigator-initiated Canadian multicenter randomized , double-blind placebo-controlled trial .
METHODS	HIV-HCV coinfected patients were randomized in a 1:1 ratio to receive citalopram or placebo 3 weeks prior to starting PEG-IFN-2b / ribavirin , stratified by study center and HCV genotype .
METHODS	The protocol design permitted the comparison of prophylaxis with the treatment of emergent depression .
METHODS	The primary outcomes were adherence ( assessed through questionnaire and returned medication ) and time to moderate depression measured by Beck Depression Inventory-II ( BDI - II ) score greater than 15 , confirmed 2 weeks apart .
RESULTS	Seventy-six patients ( 36 citalopram/40 placebo ) were randomized .
RESULTS	Overall adherence was high , ranging from 95 % ( week 12 ) to 91 % ( week 48 ) .
RESULTS	There was no difference between arms with respect to mean or median adherence at any study time point .
RESULTS	Cumulative incidence of moderate depression did not differ significantly by group ( log rank P = .32 ) .
RESULTS	The hazard ratio for moderate depression was 0.81 ( 95 % CI , 0.26 to 2.54 ) for citalopram compared with placebo when adjusted for baseline BDI-II score .
CONCLUSIONS	A strategy of prophylactic citalopram compared to treatment of emergent depression was not associated with higher adherence or a reduction in treatment-limiting depression nor did it significantly reduce depressive symptoms among HIV-HCV coinfected persons during treatment for HCV .

###24568917
OBJECTIVE	To investigate the impact of continuous blood purification ( CBP ) on T-cell subsets and prognosis in children with severe sepsis .
METHODS	A total of 42 children with severe sepsis were randomly divided into a control group ( n = 22 ) and a CBP group ( n = 20 ) .
METHODS	The patients in the control group received conventional treatment , while those in the CBP group underwent continuous veno-venous hemofiltration daily 12-24 hours for 3 days besides conventional treatment .
METHODS	Changes in clinical variables and in peripheral blood regulatory T cell subsets were assessed 3 and 7 days after treatment .
RESULTS	The pediatric intensive care unit length of stay and duration of mechanical ventilation were significantly shortened and the 28-day mortality rate was significantly lower in the CPB treatment group as compared with the control group ( P < 0.05 ) .
RESULTS	In the CBP treatment group , the percentage of CD3 ( + ) , CD4 ( + ) , CD8 ( + ) T cell populations and PCIS scores were significantly higher at 3 and 7 days after treatment than before treatment ( P < 0.05 ) .
RESULTS	At 7 days after treatment , the percentage of CD3 ( + ) , CD4 ( + ) , CD8 ( + ) T cell populations , CD4 ( + ) / CD8 ( + ) ratio and PCIS scores were significantly higher in the CBP group than in the control group ( P < 0.05 ) .
CONCLUSIONS	The CBP treatment may counteract the suppression of immune function and thus improve prognosis in children with severe sepsis .

###24661819
BACKGROUND	While living with others has been associated with improved functional outcome after acute stroke , it is unclear if this affects adherence to stroke prevention measures .
OBJECTIVE	We examined the relationship between living arrangements and adherence to antiplatelet therapy assignment and participation status in an international randomized trial for secondary stroke prevention .
METHODS	Antiplatelet therapy adherence , trial retention outcomes , and baseline characteristics for participants enrolled in the Secondary Prevention of Small Subcortical Strokes study were compared between those who lived alone vs. with others ( n = 2374 ) .
METHODS	Participant status at end-of-trial was categorized into ( 1 ) on assigned antiplatelet , ( 2 ) off assigned antiplatelet by participant request , or ( 3 ) participant withdrew consent/lost to follow-up .
METHODS	Multivariable multivariate logistic regression was used to identify patient features at entry predictive of participant status at trial end .
RESULTS	Living arrangement , alone vs. with other ( s ) , was not significantly associated with participant status .
RESULTS	Participants enrolled in the United States/Canada ( odds ratio 3.1 , confidence intervals 2.0-5 .0 , vs. Latin America ) , taking more ( 7 + ) prescription medications ( odds ratio 1.7 , confidence intervals 1.1-2 .7 , vs. 0-2 medications ) , and scoring lower on the Stroke Specific Quality of Life scale ( odds ratio 1.3 , confidence intervals 1.1-1 .5 , per 10 points ) were more likely to withdraw or become lost to follow-up in the study vs. completing the study on assigned antiplatelet therapy .
RESULTS	Participants enrolled in the United States/Canada ( odds ratio 5.0 , confidence intervals 2.4-10 .0 , vs. Latin America ) and taking fewer ( 0-2 ) medications ( odds ratio 1.9 , confidence intervals 1.2-3 .1 vs. 3-6 medications ) were more likely to request discontinuation of assigned antiplatelet medication vs. completing the study .
CONCLUSIONS	Living with others was not independently predictive of protocol adherence in this cohort .
CONCLUSIONS	Number of medications and Stroke Specific Quality of Life scale score may be more indicative of likelihood of trial participation and acceptance of long-term antiplatelet regimen .

###25695111
BACKGROUND	Short sleep duration is a contributing factor for decreased insulin sensitivity and hyperglycemia .
BACKGROUND	Sleep architecture represents a cyclical pattern of sleep that shifts between sleep Stages N1 , N2 , N3 ( slow wave sleep ) and Stage R ( rapid eye movement sleep ) .
BACKGROUND	The aim of the present study was to examine the association between sleep architecture and glucose and insulin metabolism in both normal weight and overweight/obese children and adolescents .
METHODS	A total of 118 subjects participated in the study .
METHODS	Subjects under-went overnight polysomnography ( PSG ) when the percentage of total sleep time ( % TST ) spent at each sleep stage was recorded and an oral glucose tolerance test together was performed the next morning .
METHODS	We assessed glucose tolerance , insulin sensitivity and pancreatic - cell function using 2-h glucose levels , the Matsuda index ( IS ( OGTT ) ) , and insulin secretion-sensitivity index-2 ( ISSI-2 ) , respectively .
RESULTS	After adjustment for age , gender , body mass index z-score , pubertal status , and obstructive apnea hypopnea index , Stage N3 ( % TST ) was positively associated with IS ( OGTT ) , whereas Stage N1 ( % TST ) exerted an opposite effect on IS ( OGTT ) .
RESULTS	Higher sleep efficiency and longer TST were independently associated with lower 2-h glucose levels , higher ISSI-2 and/or higher IS ( OGTT ) .
CONCLUSIONS	Stage N3 , sleep efficiency and TST were protective factors in maintaining glucose and insulin homeostasis ; however , Stage N1 functioned in the opposite direction .

###25668261
OBJECTIVE	Although blood donation is allowed every 8 weeks in the United States , recovery of hemoglobin to the currently accepted standard ( 12.5 g/dL ) is frequently delayed , and some donors become anemic .
OBJECTIVE	To determine the effect of oral iron supplementation on hemoglobin recovery time ( days to recovery of 80 % of hemoglobin removed ) and recovery of iron stores in iron-depleted ( `` low ferritin , '' 26 ng/mL ) and iron-replete ( `` higher ferritin , '' > 26 ng/mL ) blood donors .
METHODS	Randomized , nonblinded clinical trial of blood donors stratified by ferritin level , sex , and age conducted in 4 regional blood centers in the United States in 2012 .
METHODS	Included were 215 eligible participants aged 18 to 79 years who had not donated whole blood or red blood cells within 4 months .
METHODS	One tablet of ferrous gluconate ( 37.5 mg of elemental iron ) daily or no iron for 24 weeks ( 168 days ) after donating a unit of whole blood ( 500 mL ) .
METHODS	Time to recovery of 80 % of the postdonation decrease in hemoglobin and recovery of ferritin level to baseline as a measure of iron stores .
RESULTS	The mean baseline hemoglobin levels were comparable in the iron and no-iron groups and declined from a mean ( SD ) of 13.4 ( 1.1 ) g/dL to 12.0 ( 1.2 ) g/dL after donation in the low-ferritin group and from 14.2 ( 1.1 ) g/dL to 12.9 ( 1.2 ) g/dL in the higher-ferritin group .
RESULTS	Compared with participants who did not receive iron supplementation , those who received iron supplementation had shortened time to 80 % hemoglobin recovery in both the low-ferritin ( mean , 32 days , interquartile range [ IQR ] , 30-34 , vs 158 days , IQR , 126 - > 168 ) and higher-ferritin groups ( 31 days , IQR , 29-33 , vs 78 days , IQR , 66-95 ) .
RESULTS	Median time to recovery to baseline ferritin levels in the low-ferritin group taking iron was 21 days ( IQR , 12-84 ) .
RESULTS	For participants not taking iron , recovery to baseline was longer than 168 days ( IQR , 128 - > 168 ) .
RESULTS	Median time to recovery to baseline in the higher-ferritin group taking iron was 107 days ( IQR , 75-141 ) , and for participants not taking iron , recovery to baseline was longer than 168 days ( IQR , > 168 - > 168 ) .
RESULTS	Recovery of iron stores in all participants who received supplements took a median of 76 days ( IQR , 20-126 ) ; for participants not taking iron , median recovery time was longer than 168 days ( IQR , 147 - > 168 days ; P < .001 ) .
RESULTS	Without iron supplements , 67 % of participants did not recover iron stores by 168 days .
CONCLUSIONS	Among blood donors with normal hemoglobin levels , low-dose iron supplementation , compared with no supplementation , reduced time to 80 % recovery of the postdonation decrease in hemoglobin concentration in donors with low ferritin ( 26 ng/mL ) or higher ferritin ( > 26 ng/mL ) .
BACKGROUND	clinicaltrials.gov Identifier : NCT01555060 .

###25493397
OBJECTIVE	AZD6280 is a novel - aminobutyric acid A receptor modulator with higher in vitro efficacy at the 2,3 subtypes as compared to the 1 and 5 subtypes .
OBJECTIVE	This study compared the pharmacodynamic effects of single oral dose AZD6280 10 mg and 40 mg on the central nervous system with 2 mg of lorazepam .
METHODS	Sixteen healthy males were enrolled into the double-blind , randomized , 4-way crossover study .
METHODS	Two validated central nervous system test batteries , Neurocart and CogState , were administered to measure drug effects on cognition , neurophysiologic function , and psychomotor and subjective feelings .
METHODS	Statistical analysis was performed using mixed model analysis of variance , with fixed factors of treatment , period , time and treatment by time , and random factors of subject , subject by treatment and subject by time , and the average prevalue as covariate .
RESULTS	Most pharmacodynamic parameters were affected by lorazepam .
RESULTS	AZD6280 induced dose-dependent smaller-than-lorazepam effects on saccadic peak velocity ( SPV ) ( AZD6280 , 10 mg vs. AZD6280 , 40 mg vs. lorazepam [ deg/s ] : -22.6 vs. -50.0 vs. -62.9 , P < 0.001 ) , whereas the impacts on adaptive-tracking , body-sway , smooth-pursuit , and the one-card-learning tests were significant but much smaller than lorazepam .
RESULTS	Thus , the slopes of regression lines for the Log ( Sway ) - SPV , Tracking-SPV , and Smooth-SPV relations were flatter with AZD6280 than with lorazepam .
RESULTS	AZD6280 caused a distinct electroencephalography signature from that of lorazepam .
CONCLUSIONS	The SPV responses to AZD6280 suggest potential concentration-related anxiolytic effects , whereas the smaller SPV-normalized effects of AZD6280 on various non-SPV pharmacodynamic parameters suggest a more favorable side effect profile compared to lorazepam .
CONCLUSIONS	Overall , the pharmacodynamic profile of AZD6280 matches the pharmacological specificity and selectivity of this compound at the 2,3 - aminobutyric acid A receptor subtypes .

###24859589
METHODS	Cross-sectional analysis of long-term follow-up ( LTFU ) data from 4 randomized controlled trials of operative versus nonoperative treatment for chronic low back pain .
OBJECTIVE	To examine the influence of spinal fusion on adjacent segment disc space height as an indicator of disc degeneration at LTFU .
BACKGROUND	There is ongoing debate as to whether adjacent segment disc degeneration results from the increased mechanical stress of fusion .
METHODS	Plain standing lateral radiographs were obtained at LTFU ( mean , 13 4 yr postrandomization ) in 229 of 464 ( 49 % ) patients randomized to surgery and 140 of 303 ( 46 % ) , to nonoperative care .
METHODS	Disc space height and posteroanterior displacement were measured for each lumbar segment using a validated computer-assisted distortion compensated roentgen analysis technique .
METHODS	Values were reported in units of standard deviations above or below age and sex-adjusted normal values .
METHODS	Patient-rated outcomes included the Oswestry Disability Index and pain scales .
RESULTS	Radiographs were usable in 355 of 369 ( 96 % ) patients ( 259 fusion and 96 nonoperative treatment ) .
RESULTS	Both treatment groups showed significantly lower values for disc space height of the adjacent segment than norm values .
RESULTS	There was a significant difference between treatment groups for the disc space height of the cranial adjacent segment ( in both as-treated and intention-to-treat analyses ) .
RESULTS	The mean treatment effect of fusion on adjacent segment disc space height was -0.44 SDs ( 95 % CI , -0.77 to -0.11 ; P = 0.01 ; as-treated analysis ) ; there was no group difference for posteroanterior displacement ( 0.18 SDs , 95 % confidence interval , -0.28 to 0.64 , P = 0.45 ) .
RESULTS	Adjacent level disc space height and posteroanterior displacement were not correlated with Oswestry Disability Index or pain scores at LTFU ( r = 0.010-0 .05 ; P > 0.33 ) .
CONCLUSIONS	Fusion was associated with lower disc space height at the adjacent segment after an average of 13 years of FU .
CONCLUSIONS	The reduced disc space height had no influence on patient self-rated outcomes ( pain or disability ) .
METHODS	2 .

###25458329
OBJECTIVE	To demonstrate the efficacy of exenatide versus insulin glargine on endothelial functions and cardiovascular risk markers .
METHODS	Thirty-four insulin and incretin-naive patients with type 2 diabetes mellitus ( body mass index 25-45 kg/m ( 2 ) ) who received metformin for at least two months were randomized to exenatide or insulin glargine treatment arms and followed-up for 26 weeks .
METHODS	Measurements of endothelial functions were done by ultrasonography , cardiovascular risk markers by serum enzyme-linked immunosorbent assay , and total body fat mass by bioimpedance .
RESULTS	Levels of high sensitivity-C-reactive protein and endothelin-1 decreased ( 27.5 % and 18.75 % , respectively ) in the exenatide arm .
RESULTS	However , in the insulin glargine arm , fibrinogen , monocyte chemoattractant protein-1 , leptin and endothelin-1 levels ( 13.4 , 30.2 , 47.5 , and 80 % , respectively ) increased .
RESULTS	Post-treatment flow mediated dilatation and endothelium independent vascular responses were significantly higher in both arms ( p = 0.0001 , p = 0.0001 ) .
RESULTS	Positive correlation was observed between the changes in body weight and endothelium-independent vasodilatation , leptin , plasminogen activator inhibitor type 1 and endothelin-1 in both arms ( r = 0.376 , r = 0.507 , r = 0.490 , r = 0.362 , respectively ) .
CONCLUSIONS	Insulin glargine improved endothelial functions , without leading to positive changes in cardiovascular risk markers .
CONCLUSIONS	Exenatide treatment of 26 weeks resulted in reduced body weight and improvement in certain cardiovascular risk markers and endothelial functions .

###24895799
OBJECTIVE	Paralytic ileus after laparoscopic-assisted surgery often occurs .
OBJECTIVE	We investigated whether daikenchuto ( DKT ) , a traditional Japanese herbal medicine , improves intestinal motility in patients undergoing laparoscopic-assisted colectomy for colon cancer .
METHODS	Fifty-four patients who underwent colectomy at Iwate Medical University Hospital between October 2010 and March 2012 were randomized to either the DKT group ( 7.5 g/day , p.o. ) or the control group ( lactobacillus preparation , 3g/day , p.o. ) .
METHODS	Primary endpoints included time to first flatus , bowel movement , and tolerance of diet after extubation .
METHODS	Secondary endpoints were WBC count , C-reactive protein ( CRP ) level , length of hospital stay , and postoperative ileus .
METHODS	Colonic transit time was measured using radiopaque markers and abdominal radiographs .
RESULTS	Fifty-one patients ( DKT , 26 vs. control , 25 ) were included in the per-protocol analysis .
RESULTS	The DKT group had significantly faster time until first flatus ( 67.5 + / - 13.6 h vs. 77.9 + / - 11.8 h , P < 0.01 ) and bowel movement ( 82.9 + / - 17.8 h vs. 99.5 + / - 18.9 h , P < 0.01 ) and colonic transit time ( 91.9 + / - 19.8 h vs. 115.2 + / - 12.8 h , P < 0.05 ) .
RESULTS	There were no significant intergroup differences in secondary endpoints and adverse events .
CONCLUSIONS	DKT accelerates colonic motility in patients undergoing laparoscopic-assisted colectomy for colon cancer .

###24858750
OBJECTIVE	Several epidemiologic studies have suggested a role of tomato products in decreasing the risk of the development of diseases related to oxidative stress ( cancer and other chronic diseases ) .
OBJECTIVE	Oxidative stress may result in periodontal tissue damage either directly or indirectly .
OBJECTIVE	Lycopene , a powerful antioxidant and the main carotenoid in tomato products possesses the greatest quenching ability of singlet oxygen among the various carotenoids and is effective in protecting blood lymphocytes from NOO-radical damage .
OBJECTIVE	Hence , the aim of the present study is to compare the effect of systemically administered lycopene as an adjunct to scaling and root planing in patients with gingivitis and periodontitis .
METHODS	Twenty systemically healthy patients were involved in a randomized , double-blind , parallel study and based on their clinical signs were divided into two groups of mild to moderate periodontitis ( A ) and moderate gingivitis ( B ) .
METHODS	The subjects under the groups A and B were randomly distributed between the two treatment groups : test group ( n = 5 ) , 4 mg lycopene/day for 2 weeks with oral prophylaxis ( full mouth scaling and root planing ( SRP ) completed within 24 hours ) and controls ( n = 5 ) , receiving only oral prophylaxis .
METHODS	Pre - and post-therapeutic periodontal parameters were evaluated .
RESULTS	In group A , statistically significant improvement in CAL was reported in test group as compared to control group .
RESULTS	In group B , the difference between pretreatment and post-treatment bleeding on probing scores was found to be statistically non-significant in both groups .
CONCLUSIONS	Results show that lycopene is a promising treatment modality as an adjunct to full mouth SRP of the oral cavity in patients with moderate periodontal disease .
CONCLUSIONS	Modulation of the free radical production seems to be essential for the inhibition of tissue destruction , and treatment with antioxidants , like lycopene , which is the most potent among them will block the production of free ROS or its effects might prove to be therapeutically valuable .

###24584918
OBJECTIVE	To evaluate the humoral immune response to pneumococcal and influenza vaccination in adults with rheumatoid arthritis ( RA ) receiving certolizumab pegol ( CZP ) .
METHODS	In this 6-week , single-blind , placebo-controlled trial with optional 6-month open-label extension ( NCT00993668 ) , patients were stratified by concomitant methotrexate ( MTX ) use and randomized to receive CZP 400 mg ( loading dose ; according to CZP label ) or placebo at weeks 0 , 2 , and 4 .
METHODS	Pneumococcal ( polysaccharide 23 ) and influenza vaccines were administered at Week 2 .
METHODS	Satisfactory humoral immune response , defined as 2-fold titer increase in 3 of 6 pneumococcal antigens and 4-fold titer increase in 2 of 3 influenza antigens , were assessed independently 4 weeks after vaccination .
RESULTS	Following pneumococcal vaccination , 62.5 % of placebo patients and 54.5 % of CZP patients without effective titers at baseline achieved a humoral response ( difference in proportions was -8.0 percentage points ; 95 % CI -22.5 to 6.6 % ) .
RESULTS	Following influenza vaccination , 61.4 % of placebo and 53.5 % of CZP patients without effective titers at baseline achieved a humoral response ( difference in proportions : -8.0 percentage points ; 95 % CI -22.9 to 7.0 % ) .
RESULTS	In all patients , including those with effective titers at baseline , 58.2 % of placebo and 53.3 % of CZP patients developed satisfactory pneumococcal titers , and 54.1 % of placebo and 50.5 % of CZP patients developed satisfactory influenza antibody titers .
RESULTS	Vaccine responses to pneumococcal and influenza antigens were reduced similarly in both treatment groups with concomitant MTX use .
CONCLUSIONS	Humoral immune responses to pneumococcal and influenza vaccination are not impaired when given during the loading phase of CZP treatment in patients with RA .
CONCLUSIONS	( ClinicalTrials.gov NCT00993668 ) .

###25157000
OBJECTIVE	The goal of this study was to evaluate the impact of the Active Teen Leaders Avoiding Screen-time ( ATLAS ) intervention for adolescent boys , an obesity prevention intervention using smartphone technology .
METHODS	ATLAS was a cluster randomized controlled trial conducted in 14 secondary schools in low-income communities in New South Wales , Australia .
METHODS	Participants were 361 adolescent boys ( aged 12-14 years ) considered at risk of obesity .
METHODS	The 20-week intervention was guided by self-determination theory and social cognitive theory and involved : teacher professional development , provision of fitness equipment to schools , face-to-face physical activity sessions , lunchtime student mentoring sessions , researcher-led seminars , a smartphone application and Web site , and parental strategies for reducing screen-time .
METHODS	Outcome measures included BMI and waist circumference , percent body fat , physical activity ( accelerometers ) , screen-time , sugar-sweetened beverage intake , muscular fitness , and resistance training skill competency .
RESULTS	Overall , there were no significant intervention effects for BMI , waist circumference , percent body fat , or physical activity .
RESULTS	Significant intervention effects were found for screen-time ( mean SE : -30 10.08 min/d ; P = .03 ) , sugar-sweetened beverage consumption ( mean : -0.6 0.26 glass/d ; P = .01 ) , muscular fitness ( mean : 0.9 0.49 repetition ; P = .04 ) , and resistance training skills ( mean : 5.7 0.67 units ; P < .001 ) .
CONCLUSIONS	This school-based intervention targeting low-income adolescent boys did not result in significant effects on body composition , perhaps due to an insufficient activity dose .
CONCLUSIONS	However , the intervention was successful in improving muscular fitness , movement skills , and key weight-related behaviors .

###24962635
OBJECTIVE	Gemigliptin is approved for the treatment of type II diabetes mellitus .
OBJECTIVE	Sulfonylureas are commonly used in combination with other antidiabetic drugs to improve glycemic control .
OBJECTIVE	The objective of this study was to evaluate the pharmacokinetics , safety , and tolerability of gemigliptin and glimepiride combination therapy compared with those of monotherapies .
METHODS	A randomized , open-label , crossover study was performed on healthy Korean male volunteers .
METHODS	Each subject received the following treatments ( A and B ) with a 7-day washout period : treatment A consisted of gemigliptin 50 mg once daily administered orally for 6 days , followed by concomitant oral dosing of glimepiride 4 mg and gemigliptin 50 mg on day 7 ; treatment B consisted of a single dose of glimepiride 4 mg .
METHODS	Blood samples were collected up to 24-h postdose on day 6 ( gemigliptin ) and day 7 ( gemigliptin and glimepiride ) following treatment A , and on day 1 ( glimepiride ) following treatment B. Concentrations of gemigliptin , glimepiride , and metabolites were determined using validated liquid chromatography-tandem mass spectrometry ( LC-MS/MS ) .
METHODS	Safety assessments were performed throughout the study .
RESULTS	Twenty-three subjects completed the study .
RESULTS	The geometric mean ratios ( GMRs ) of C max , ss and AUC , ss for gemigliptin were 1.0097 [ 90 % confidence interval ( CI ) 0.924-1 .103 ] and 0.9997 ( 90 % CI 0.976-1 .024 ) , respectively .
RESULTS	For glimepiride , the GMRs of C max and AUClast were 1.031 ( 90 % CI 0.908-1 .172 ) and 0.995 ( 90 % CI 0.902-1 .097 ) , respectively .
RESULTS	Both combination and monotherapy were well tolerated , and no serious adverse events were reported .
CONCLUSIONS	Gemigliptin and glimepiride did not alter the pharmacokinetic properties of each other when they were co-administered in healthy volunteers , and were generally tolerated .

###24399553
OBJECTIVE	It is estimated that more than half of those with serious mental illness smoke tobacco regularly .
OBJECTIVE	Standard courses of pharmacotherapeutic cessation aids improve short-term abstinence , but most who attain abstinence relapse rapidly after discontinuation of pharmacotherapy .
OBJECTIVE	To determine whether smokers diagnosed with schizophrenia and bipolar disease have higher rates of prolonged tobacco abstinence with maintenance pharmacotherapy than with standard treatment .
METHODS	Randomized , double-blind , placebo-controlled , parallel-group , relapse-prevention clinical trial conducted in 10 community mental-health centers .
METHODS	Of 247 smokers with schizophrenia or bipolar disease recruited from March 2008-April 2012 , 203 received 12-weeks ' open-label varenicline and cognitive behavioral therapy and 87 met abstinence criteria to enter the relapse prevention intervention .
METHODS	Participants who had 2 weeks or more of continuous abstinence at week 12 of open treatment were randomly assigned to receive cognitive behavioral therapy and double-blind varenicline ( 1 mg , 2 per day ) or placebo from weeks 12 to 52 .
METHODS	Participants then discontinued study treatment and were followed up to week 76 .
METHODS	Seven-day rate of continuous abstinence at study week 52 , the end of the relapse-prevention phase , confirmed by exhaled carbon monoxide .
METHODS	Secondary outcomes were continuous abstinence rates for weeks 12 through 64 based on biochemically verified abstinence and weeks 12 through 76 , based on self-reported smoking behavior .
RESULTS	Sixty-one participants completed the relapse-prevention phase ; 26 discontinued participation ( 7 varenicline , 19 placebo ) and were considered to have relapsed for the analyses ; 18 of these had relapsed prior to dropout .
RESULTS	At week 52 , point-prevalence abstinence rates were 60 % in the varenicline group ( 24 of 40 ) vs 19 % ( 9 of 47 ) in the placebo group ( odds ratio [ OR ] , 6.2 ; 95 % CI , 2.2-19 .2 ; P < .001 ) .
RESULTS	From weeks 12 through 64 , 45 % ( 18 of 40 ) among those in the varenicline group vs 15 % ( 7 of 47 ) in the placebo group were continuously abstinent ( OR , 4.6 ; 95 % CI , 1.5-15 .7 ; P = .004 ) , and from weeks 12 through 76 , 30 % ( 12 of 40 ) in the varenicline group vs 11 % ( 5 of 47 ) in the placebo group were continuously abstinent ( OR , 3.4 ; 95 % CI , 1.02-13 .6 ; P = .03 ) .
RESULTS	There were no significant treatment effects on psychiatric symptom ratings or psychiatric adverse events .
CONCLUSIONS	Among smokers with serious mental illness who attained initial abstinence with standard treatment , maintenance pharmacotherapy with varenicline and cognitive behavioral therapy improved prolonged tobacco abstinence rates compared with cognitive behavioral therapy alone after 1 year of treatment and at 6 months after treatment discontinuation .
BACKGROUND	clinicaltrials.gov Identifier : NCT00621777 .

###25536706
BACKGROUND	Insufficient production oferythropoietin ( EPO ) is the primary cause ofanemia in patients with chronic kidney disease ( CKD ) .
BACKGROUND	The EPO treatment is an established treatment for renal anemia .
BACKGROUND	The study investigated the therapeutic outcome between lyophilized powder and liquid form of EPO alpha by intravenous ( IV ) administration in hemoglobin maintenance of anemic treatment for CKD patients receiving hemodialysis .
METHODS	Forty patients were randomly assigned to either lyophilized powder of EPO alpha ( treatment , n = 21 ) or liquidform of EPO alpha ( control , n = 19 ) for 12 weeks by lVadministration .
METHODS	The hemoglobin was maintained within the target range of 10.0 to 12.0 g/dL by adjusting the dosage of EPO .
METHODS	The clinical and biochemical profiles including transferrin saturation andferritin were measured .
METHODS	Adverse events were documented .
RESULTS	The mean hemoglobin ofboth groups at baseline was 11.20.6 g/dL .
RESULTS	Mean hemoglobin and mean hematocrit levels at baseline , and follow-up data of both groups were not statistically different .
RESULTS	The mean weekly dosage of EPO in the treatment and control groups had no statistical significance within the same group and between groups as well .
RESULTS	Stable hemoglobin levels were maintained without EPO dosage adjustment in the majority ofpatients in both groups ( treatment group , 90.5 % , control group , 94.7 % ) .
RESULTS	During the 12-week study period , no serious side effect was detected
CONCLUSIONS	The present study demonstrated that the lyophilizedpowder ofEPO alpha was effective and safe as the standard liquid form of EPO alpha when it was administered by IV route in hemoglobin maintenance of anemia treatment .

###25023813
OBJECTIVE	The objective of this study was to assess the prognostic significance of exercise capacity in patients with ischemic left ventricular ( LV ) dysfunction eligible for coronary artery bypass graft surgery ( CABG ) .
BACKGROUND	Poor exercise capacity is associated with mortality , but it is not known how this influences the benefits and risks of CABG compared with medical therapy .
METHODS	In an exploratory analysis , physical activity was assessed by questionnaire and 6-min walk test in 1,212 patients before randomization to CABG ( n = 610 ) or medical management ( n = 602 ) in the STICH ( Surgical Treatment for Ischemic Heart Failure ) trial .
METHODS	Mortality ( n = 462 ) was compared by treatment allocation during 56 months ( interquartile range : 48 to 68 months ) of follow-up for subjects able ( n = 682 ) and unable ( n = 530 ) to walk 300 m in 6 min and with less ( Physical Ability Score [ PAS ] > 55 , n = 749 ) and more ( PAS 55 , n = 433 ) limitation by dyspnea or fatigue .
RESULTS	Compared with medical therapy , mortality was lower for patients randomized to CABG who walked 300 m ( hazard ratio [ HR ] : 0.77 ; 95 % confidence interval [ CI ] : 0.59 to 0.99 ; p = 0.038 ) and those with a PAS > 55 ( HR : 0.79 ; 95 % CI : 0.62 to 1.01 ; p = 0.061 ) .
RESULTS	Patients unable to walk 300 m or with a PAS 55 had higher mortality during the first 60 days with CABG ( HR : 3.24 ; 95 % CI : 1.64 to 6.83 ; p = 0.002 ) and no significant benefit from CABG during total follow-up ( HR : 0.95 ; 95 % CI : 0.75 to 1.19 ; p = 0.626 ; interaction p = 0.167 ) .
CONCLUSIONS	These observations suggest that patients with ischemic left ventricular dysfunction and poor exercise capacity have increased early risk and similar 5-year mortality with CABG compared with medical therapy , whereas those with better exercise capacity have improved survival with CABG .
CONCLUSIONS	( Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease [ STICH ] ; NCT00023595 ) .

###25051389
OBJECTIVE	Physical activity ( PA ) declines dramatically during adolescence , and activity levels are consistently lower among children living in low-income communities .
OBJECTIVE	Competency in a range of fundamental movement skills ( FMS ) may serve as a protective factor against the decline in PA typically observed during adolescence .
OBJECTIVE	The purpose of this study was to evaluate the effect of a 12-month multicomponent PA and FMS intervention on children attending primary schools in low-income communities .
METHODS	The Supporting Children 's Outcomes using Rewards , Exercise , and Skills intervention was evaluated using a cluster randomized controlled trial .
METHODS	The sample included 25 classes from eight primary schools located in low-income communities .
METHODS	Participants were 460 children ( 54.1 % girls ) age 8.5 0.6 yr .
METHODS	Primary outcomes were objectively measured PA ( ActiGraph GT3X and GT3X + accelerometers ) , FMS competency ( Test of Gross Motor Development 2 , six locomotor and six object control skills ) , and cardiorespiratory fitness ( 20-m multistage fitness test ) assessed at baseline , midprogram ( 6-months ) , and at posttest ( 12 months ) .
METHODS	Linear mixed models , adjusted for sex , age , body mass index z-score , socioeconomic status , ethnicity , and school class as a random factor , were used to assess the effect of the intervention .
RESULTS	At midprogram , there were no significant intervention effects for any of the outcomes .
RESULTS	At posttest ( study 's primary time point ) , there were intervention effects for daily moderate-to-vigorous PA ( MVPA ) ( adjusted mean difference , 12.7 mind of MVPA ; 95 % confidence interval ( CI ) , 5.0-20 .5 ) , overall FMS competency ( 4.9 units ; 95 % CI , -0.04 to 9.8 ) , and cardiorespiratory fitness ( 5.4 laps ; 95 % CI , 2.3-8 .6 ) .
CONCLUSIONS	A school-based multicomponent PA and FMS intervention maintained daily MVPA , improved overall FMS competency , and increased cardiorespiratory fitness among children attending primary schools in low-income communities .

###24375222
OBJECTIVE	This study determined the effective concentration of ropivacaine required to produce the type of differential block known as sensory block with mobilization , for adequate analgesia after forearm or hand soft tissue surgery by axillary brachial plexus block .
METHODS	Forty-four patients were enrolled , and ultrasound-guided axillary nerve block with nerve stimulation was achieved using 16 mL of ropivacaine in total .
METHODS	Postoperative analgesia and sensory/motor function , side effects , the use of rescue analgesics , and the patient satisfaction score were evaluated 24 h after surgery .
METHODS	The effective concentration of nerve block was calculated by probit analysis .
RESULTS	Eighteen patients achieved differential block and were sufficiently satisfied with the block , which was significantly better than the patient satisfaction obtained with incomplete differential block .
RESULTS	The maximum effective concentration of 6 mL of ropivacaine needed for differential block was calculated as 0.1285 % , which meant that 71 % of the patients experienced both sensory block and maintenance of motor function .
CONCLUSIONS	This analysis showed that 16 ml of 0.1285 % ropivacaine is suitable for achieving differential block in ultrasound-guided axillary nerve block for hand and forearm surgery .

###24629063
BACKGROUND	Hand osteoarthritis ( OA ) is one of the most prevalent musculoskeletal diseases in an adult population and may have a large influence on an individual 's functioning , health-related quality of life and participation in society .
BACKGROUND	Several studies have demonstrated that exercises may reduce pain and improve functioning in people with knee OA , with a similar effect suggested for hip OA .
BACKGROUND	For hand OA , available research is very limited and shows conflicting results , and high-quality randomised controlled trials are warranted.This paper outlines the protocol for a randomised controlled trial that aims to determine the effect of an exercise intervention on self-reported hand activity performance in people with hand OA .
METHODS	Participants with physician-confirmed hand OA according to the ACR clinical criteria are being recruited from two Norwegian OA cohorts : the population-based `` Musculoskeletal pain in Ullensaker Study '' ( MUST ) OA cohort , and the hospital-based Oslo Hand OA cohort .
METHODS	Participants are randomised into an intervention - or control group .
METHODS	The control group receives `` usual care '' , whereas the intervention group receives a 12-week exercise intervention .
METHODS	The intervention group attends four group sessions and is instructed to perform the exercise program three times a week at home .
METHODS	Adherence will be captured using self-report .
METHODS	During the eight weeks with no group sessions , the intervention group receives a weekly telephone call .
METHODS	The assessments and group sessions are being conducted locally in Ullensaker Municipality and at Diakonhjemmet Hospital , Oslo .
METHODS	Outcomes are collected at baseline , and at 3 and 6 months .
METHODS	The primary outcome measure is self-reported hand activity performance at 3 months post-randomisation , as measured by the Functional Index for Hand Osteoarthritis ( FIHOA ) ; and a patient-generated measure of disability , the Patient-Specific Functional Scale ( PSFS ) .
METHODS	Secondary outcome measures are self-reported OA symptoms ( e.g. pain , stiffness and fatigue ) , the Patient Global Assessment of disease activity , measured hand function ( e.g. grip strength , thumb web space and hand dexterity ) and health-related quality of life .
METHODS	Cost-utility and cost-effectiveness analyses will be conducted .
CONCLUSIONS	This study will contribute to the knowledge on both the effect and resource use of an exercise programme with telephone follow-up on self-reported hand activity performance among people with hand OA .
BACKGROUND	The trial is registered at ClinicalTrials.gov with registration number : NCT01245842 .

###25958716
OBJECTIVE	Investigate the benefit of zinc supplement combined with standard treatment ofidiopathic sudden sensorineural hearing loss ( ISSNHL ) patients .
METHODS	A prospective , randomized study was designed to evaluate the hearing outcomes in ISSNHL patients treated with zinc supplement .
METHODS	The patients were randomized into two groups , the study and the control group .
METHODS	The study group received oral chelated zinc with standard treatment ( oral prednisolone ) , while the control group received standard treatment alone .
METHODS	Hearing improvement was assessed from pure-tone average ( PTA ) and speech discrimination scores ( SDS ) .
RESULTS	After treatment , significant hearing improvement was noted in both groups regarding PTA value ( p = 0.016 , 0.025 ) .
RESULTS	SDS was also improved in both groups but with no statistical significance ( p > 0.05 ) .
RESULTS	Post-treatment PTA and SDS values between the zinc and control groups were not statistically different ( p > 0.05 ) .
RESULTS	Hearing improvement was documented in eight of 16 patients in the study group and seven of 14 patients in the control group .
RESULTS	This was no significant difference ( p = 1.000 ) .
CONCLUSIONS	Zinc supplementation does not have benefit when combined with standard treatment .
CONCLUSIONS	Nevertheless , more subjects and well-designed studies are needed to verify the effect of zinc .

###24320193
OBJECTIVE	To investigate the effectiveness of shared care combined with telecare in type 2 diabetic patients in an underserved community in Asia .
METHODS	In total , 95 patients with type 2 diabetes who had a glycosylated hemoglobin ( HbA1c ) level of > 7 % were recruited from six community health centers in remote areas in Changhua County , Taiwan .
METHODS	All patients were randomly divided into intervention ( shared care combined with telecare ) and usual-care groups and followed up for 6 months .
RESULTS	The decrease in HbA1c level was significantly greater in the intervention group than in the usual-care group ( 0.7 1.3 % versus 0.1 1.0 % , p = 0.03 ) .
RESULTS	There were no significant differences in lipid profiles and blood pressure changes between the two groups .
CONCLUSIONS	Shared care combined with telecare could significantly reduce HbA1c levels in type 2 diabetic patients with poor glycemic control in underserved rural communities .
CONCLUSIONS	Further studies should be conducted to clarify the target users and to develop cost-effective interventions .

###25056227
BACKGROUND	Fluticasone furoate nasal spray ( FFNS ) is a glucocorticoid developed for the treatment of allergic rhinitis ( AR ) .
BACKGROUND	This is the first randomized clinical trial to assess the efficacy and safety of FFNS in Japanese children with perennial AR ( PAR ) .
METHODS	In this multicentre , randomized , double-blind , placebo-controlled , parallel-group , phase III study , 261 children aged 6 to < 15 years were treated with FFNS 55g , once daily or placebo for two weeks .
METHODS	Nasal and ocular symptoms were rated by parents/guardians/patients in the patient daily diary .
METHODS	The primary endpoint was the mean change from baseline in the three total nasal symptom score ( 3TNSS ) .
METHODS	In addition , rhinoscopic findings were rated by the investigators as an efficacy measure .
METHODS	As a safety measure , adverse events and clinical chemistry and hematology were evaluated .
RESULTS	Mean change from baseline over the entire treatment period in 3TNSS was greater in the FFNS 55g group compared with placebo , and the difference was statistically significant ( p < 0.001 ) .
RESULTS	Significant improvements in rhinoscopic findings of swelling of inferior turbinate mucosa and quantity of nasal discharge were also observed .
RESULTS	The total ocular symptom score ( TOSS ) was reduced significantly in the FFNS 55g group , compared with placebo , in the second week in a subgroup of patients with baseline TOSS > 0 .
RESULTS	The incidence of adverse events was similar between FFNS 55g ( 18 % ) and placebo ( 19 % ) .
CONCLUSIONS	Two-week treatment with FFNS 55g , once daily is effective and tolerable in Japanese children aged 6 to < 15 years with PAR .

###24411798
OBJECTIVE	Fostering positive school climates and student drug testing have been separately proposed as strategies to reduce student drug use in high schools .
OBJECTIVE	To assess the promise of these strategies , the present research examined whether positive school climates and/or student drug testing successfully predicted changes in youth substance use over a 1-year follow-up .
METHODS	Two waves of panel data from a sample of 361 high school students , assessed 1 year apart , were analyzed .
METHODS	Changes in reported initiation and escalation in frequency of alcohol , cigarette , and marijuana use as a function of perceived student drug testing and positive school climates were analyzed , while we held constant prior substance use .
RESULTS	Perceived student drug testing was not associated with changes in substance use , whereas perceived positive school climates were associated with a reduction in cigarette and marijuana initiation and a reduction in escalation of frequency of cigarette use at 1-year follow-up .
RESULTS	However , perceived positive school climates were not associated with a reduction in alcohol use .
CONCLUSIONS	Student drug testing appears to be less associated with substance use than positive school climates .
CONCLUSIONS	Nevertheless , even favorable school climates may not be able to influence the use of alcohol , which appears to be quite normative in this age group .

###24369301
OBJECTIVE	More patient-centered programming is essential for endometrial cancer ( EC ) survivors needing to lose weight to reduce cardiovascular disease risk ( CVD ) .
OBJECTIVE	The purpose of this study was to improve self-efficacy ( SE ) and quality of life ( QOL ) using a lifestyle intervention program designed for weight loss .
METHODS	Overweight and obese early-stage EC survivors , n = 75 , were randomized into two groups : 1 ) Survivors of Uterine Cancer Empowered by Exercise and Healthy Diet ( SUCCEED ) , a six-month lifestyle intervention or 2 ) a usual care group ( UC ) .
METHODS	Participants completed the Weight Efficacy Lifestyle Questionnaire ( WEL ) to assess SE and the Functional Assessment of Cancer Therapy-General ( FACT-G ) to measure QOL , and their body mass index ( BMI ) was calculated at baseline , 3 , 6 , and 12 months .
METHODS	Mixed , repeated-measures ANCOVA models with baseline covariates were employed using SPSS 20.0 .
RESULTS	Positive effects in every WEL domain , including the total score , were statistically significant in the SUCCEED group versus the UC group .
RESULTS	A linear regression model demonstrated that , if BMI decreased by 1 unit , the total WEL score increased by 4.49 points .
RESULTS	Significant negative correlations were found in the total WEL score and a change in BMI of R = -0.356 ( p = 0.006 ) .
RESULTS	Between-group differences in the FACT-G were significant from baseline in the fatigue domain at three months ( p = .008 ) and in the physical domain at six months ( p = .048 ) .
RESULTS	No other significant differences were found .
CONCLUSIONS	Overall , this study shows promise for targeted interventions to help improve SE , thus improving BMI .

###25066140
OBJECTIVE	The aim of our study was to determine whether the combination of intratympanic ( IT ) corticosteroid with melatonin could be associated with decreased tinnitus in patients with unilateral acute idiopathic tinnitus developed within 3months .
METHODS	We evaluated this hypothesis through a prospective , randomized , controlled , double-blinded trial .
METHODS	Patients included in the study were randomly allocated into two groups : Group A - comprising 30 patients , received melatonin and IT dexamethazone , and Group B - including 30 patients receiving melatonin alone .
METHODS	After 3 months , improvement in tinnitus was assessed using different outcome measures : tinnitus loudness score , tinnitus awareness score , Tinnitus Handicap Inventory ( THI ) , Pittsburgh Sleep Quality Index ( PSQI ) and Beck Depression Inventory ( BDI ) .
RESULTS	We have demonstrated significant improvements in each of the above mentioned outcomes subsequent to treatment in both groups .
RESULTS	However , patients in the IT dexamathazone and melatonin group attained statistically significant better outcomes .
RESULTS	Besides , the differences in improvement rate and cure rate were highly significant between the two groups , favoring the IT dexamethazone and melatonin group .
CONCLUSIONS	Our preliminary study demonstrated that IT dexamethazone plus melatonin is efficient in improvement of idiopathic unilateral tinnitus developed within 3 months .

###24268886
BACKGROUND	This study aimed to assess the predictive validity of the Alcohol Use Disorders Identification Test ( AUDIT ) among adult prisoners with respect to hazardous drinking following release , and identify predictors of post-release hazardous drinking among prisoners screening positive for risk of alcohol-related harm on the AUDIT .
METHODS	Data came from a survey-based longitudinal study of 1325 sentenced adult prisoners in Queensland , Australia .
METHODS	Baseline interviews were conducted pre-release with follow-up at 3 and 6 months post-release .
METHODS	We calculated sensitivity , specificity and area under the receiver operating characteristic ( AUROC ) to quantify the predictive validity of the AUDIT administered at baseline with respect to post-release hazardous drinking .
METHODS	Other potential predictors of hazardous drinking were measured by self-report and their association with the outcome was examined using logistic regression .
RESULTS	At a cut-point of 8 or above , sensitivity of the AUDIT with respect to hazardous drinking at 3-month follow-up was 81.0 % ( 95 % CI : 77.9-84 .6 % ) and specificity was 65.6 % ( 95 % CI : 60.6-70 .3 % ) .
RESULTS	The AUROC was 0.78 ( 95 % CI : 0.75-0 .81 ) , indicating moderate accuracy .
RESULTS	Among those scoring 8 or above , high expectations to drink post-release ( AOR : 2.49 ; 95 % CI : 1.57-3 .94 ) and past amphetamine-type stimulant ( ATS ) use ( AOR : 1.64 ; 95 % CI : 1.06-2 .56 ) were significantly associated with hazardous drinking at 3 months post-release .
RESULTS	Results were similar at 6 months .
CONCLUSIONS	Among adult prisoners in our sample , pre-release AUDIT scores predicted hazardous drinking six months after release with acceptable accuracy , sensitivity and specificity .
CONCLUSIONS	Among prisoners screening positive on the AUDIT , expectations of post-release drinking and ATS use are potential targets for intervention to reduce future hazardous drinking .

###25819860
BACKGROUND	Clinical outcomes and the effects of oral anticoagulants among patients with acute coronary syndrome ( ACS ) and either a history of or acute heart failure ( HF ) are largely unknown .
BACKGROUND	We aimed to assess the relationship between prior HF or acute HF complicating an index ACS event and subsequent clinical outcomes and the efficacy and safety of apixaban compared with placebo in these populations .
METHODS	High-risk patients were randomly assigned post-ACS to apixaban 5.0 mg or placebo twice daily .
METHODS	Median follow-up was 8 ( 4-12 ) months .
METHODS	The primary outcome was cardiovascular death , myocardial infarction , or stroke .
METHODS	The main safety outcome was thrombolysis in myocardial infarction major bleeding .
RESULTS	Heart failure was reported in 2,995 patients ( 41 % ) , either as prior HF ( 2,076 [ 28 % ] ) or acute HF ( 2,028 [ 27 % ] ) .
RESULTS	Patients with HF had a very high baseline risk and were more often managed medically .
RESULTS	Heart failure was associated with a higher rate of the primary outcome ( prior HF : adjusted hazard ratio [ HR ] 1.73 , 95 % CI 1.42-2 .10 , P < .0001 , acute HF : adjusted HR 1.65 , 95 % CI 1.35-2 .01 , P < .0001 ) and cardiovascular death ( prior HF : HR 2.54 , 95 % CI 1.82-3 .54 , acute HF : adjusted HR 2.52 , 95 % CI 1.82-3 .50 ) .
RESULTS	Patients with acute HF also had significantly higher rates of thrombolysis in myocardial infarction major bleeding ( prior HF : adjusted HR 1.22 , 95 % CI 0.65-2 .27 , P = .54 , acute HF : adjusted HR 1.78 , 95 % CI 1.03-3 .08 , P = .04 ) .
RESULTS	There was no statistical evidence of a differential effect of apixaban on clinical events or bleeding in patients with or without prior HF ; however , among patients with acute HF , there were numerically fewer events with apixaban than placebo ( 14.8 vs 19.3 , HR 0.76 , 95 % CI 0.57-1 .01 , interaction P = .13 ) , a trend that was not seen in patients with prior HF or no HF .
CONCLUSIONS	In high-risk patients post-ACS , both prior and acute HFs are associated with an increased risk of subsequent clinical events .
CONCLUSIONS	Apixaban did not significantly reduce clinical events and increased bleeding in patients with and without HF ; however , there was a tendency toward fewer clinical events with apixaban in patients with acute HF .

###25613214
OBJECTIVE	It was the aim of this study to find an optimal therapeutic regimen of transarterial chemoembolization ( TACE ) by comparing the efficacy of chemoembolization with different anticancer agents in hepatocellular carcinoma ( HCC ) patients .
METHODS	A single-blind , three-group parallel , randomized trial was conducted in Guangdong General Hospital , Guangzhou , China , with patients with biopsy-confirmed HCC .
METHODS	Group 1 received single-drug ( doxorubicin ) chemoembolization , while group 2 received double-drug ( doxorubicin and mitomycin C ) chemoembolization .
METHODS	Patients in group 3 were treated with triple-drug ( doxorubicin , mitomycin C , and gemcitabine ) chemoembolization .
METHODS	Lipiodol was used as embolization agent in all protocols .
METHODS	We compared the overall survival ( OS ) , time to progression ( TTP ) , and objective response rate ( ORR ) between groups .
METHODS	Response assessment was performed according to modified RECIST ( Response Evaluation Criteria In Solid Tumors ) criteria .
RESULTS	Between January 2008 and January 2011 , 162 patients ( group 1 , n = 50 ; group 2 , n = 59 ; group 3 , n = 53 ) were recruited .
RESULTS	The OS and TTP in groups 1 , 2 , and 3 were 14.9 and 6.4 , 13.2 and 6.4 , and 20.5 and 6.8 months , respectively .
RESULTS	OS and TTP were statistically significant among groups ( p = 0.002 and p = 0.037 ) .
RESULTS	The ORR was 22.0 , 40.7 , and 56.6 % , respectively .
RESULTS	The ORR was significantly different across the three groups ( p < 0.002 ) .
CONCLUSIONS	TACE with multiple chemotherapeutic agents might significantly increase survival and tumor response ; additionally , gemcitabine was likely to have an advantage in improving the prognosis of HCC patients .
CONCLUSIONS	2015 S. Karger AG , Basel .

###24243529
OBJECTIVE	Many patients with type 2 diabetes mellitus ( T2DM ) on insulin therapy have inadequate glycaemic control .
OBJECTIVE	In such cases , Dutch guidelines recommend unlimited up-titration of insulin , yet in practice many patients never reach their glycaemic target .
OBJECTIVE	Clinical evidence shows that dapagliflozin-a highly selective sodium-glucose cotransporter 2 inhibitor-meets a need for these patients , i.e. by reducing glycated haemoglobin levels and bodyweight .
OBJECTIVE	We estimated the cost effectiveness and cost utility of adding dapagliflozin to insulin compared with not adding dapagliflozin in patients with T2DM who have inadequate glycaemic control while on insulin .
METHODS	The cost effectiveness of dapagliflozin was estimated using the Cardiff Diabetes Model , using direct comparative efficacy data from a randomized placebo-controlled trial ( ClinicalTrials.gov identifier NCT00673231 ) .
METHODS	In this trial , up-titration of insulin was allowed in case of severe glycaemic imbalance .
METHODS	Risk factor progression and the occurrence of future vascular events were estimated using the United Kingdom Prospective Diabetes Study 68 risk equations .
METHODS	Costs and utilities were derived from the literature .
METHODS	The analysis was conducted from the societal perspective , simulating the remaining lifetime of the patients .
RESULTS	The overall incidence of macro - and microvascular complications was lower , and life expectancy was greater ( 19.43 versus 19.35 life-years [ LYs ] ) in patients receiving dapagliflozin than in those not receiving dapagliflozin .
RESULTS	Patients in the dapagliflozin arm obtained an incremental benefit of 0.42 quality-adjusted life-years ( QALYs ) .
RESULTS	The lifetime incremental cost per patient in the dapagliflozin arm was 2,293 , resulting in an incremental cost-effectiveness ratio of 27,779 per LY gained and an incremental cost-utility ratio of 5,502 per QALY gained .
RESULTS	Sensitivity and scenario analyses showed that the results were insensitive to variations in modelling assumptions and input variables .
CONCLUSIONS	Dapagliflozin in combination with insulin was estimated to be a cost-effective treatment option for patients with T2DM whose insulin treatment regimen does not provide adequate glycaemic control in a Dutch healthcare setting .

###26001241
OBJECTIVE	The objective of our study was to use proton MR spectroscopy ( MRS ) to quantitatively evaluate bone marrow infiltration by measuring the fat fraction ( FF ) and to compare the FF with semiquantitative bone marrow MRI scores and clinical status in children treated for type 1 Gaucher disease ( GD ) .
METHODS	Over a 2-year period , we prospectively evaluated 10 treated GD patients ( six males , four females ; median age , 15.1 years ) and 10 healthy age-matched control subjects ( five males , five females ; median age , 15.3 years ) using 3-T proton MRS of L5 and the femoral neck .
METHODS	Water and lipid AUCs were measured to calculate the FF .
METHODS	Two blinded pediatric musculoskeletal radiologists performed a semiquantitative analysis of the conventional MR images using the bone marrow burden score and modified Spanish MRI score .
METHODS	We evaluated symptoms , spleen and liver volumes , platelet levels , hemoglobin levels , and bone complications .
RESULTS	In the femur , the FF was higher in the control subjects ( median , 0.71 ) than the GD patients ( 0.54 ) ( p = 0.02 ) .
RESULTS	In L5 , the difference in FF -- higher FF in control subjects ( 0.37 ) than in GD patients ( 0.26 ) -- was not significant ( p = 0.16 ) .
RESULTS	In both groups and both regions , the FF increased with patient age ( p < 0.02 ) .
RESULTS	Semiquantitative scores showed no differences between control subjects and treated GD patients ( p > 0.11 ) .
RESULTS	Eight of 10 GD patients were asymptomatic and two had chronic bone pain .
RESULTS	The median age of patients at symptom onset was 4.0 years , the median age of patients at the initiation of enzyme replacement therapy was 4.3 years , and the median treatment duration was 10.2 years .
RESULTS	Hemoglobin level , platelet count , and liver volume at MRI were normal .
RESULTS	Mean pretreatment spleen volume ( 15.4-fold above normal ) decreased to 2.8-fold above normal at the time of MRI ( p = 0.01 ) .
CONCLUSIONS	Proton MRS detected FF differences that were undetectable using conventional MRI ; for that reason , proton MRS can be used to optimize treatment of GD patients .

###25148382
BACKGROUND	Proper bioequivalence studies comparing original with generic immunosuppressive drugs in patients are limited , especially in the increasing population of elderly renal transplant recipients .
BACKGROUND	We performed an open-label , single-center , prospective , randomized , cross-over study and compared steady-state pharmacokinetics ( PK ) of a generic tacrolimus ( Tacni ) formulation with the original ( Prograf ) in renal transplant recipients older than 60 years .
METHODS	Twenty-eight patients , with a median age of 69 years ( range , 60 to 78 ) , were randomized at time of transplantation to receive original or generic tacrolimus , and 25 ( 21 men , 4 women ) provided two evaluable 12-hr PK profiles .
METHODS	The PK investigations were performed in a stable phase approximately 6 and 8 weeks postengraftment .
METHODS	After the first PK investigation , tacrolimus formulations were switched ( 1:1 dose ratio ) .
RESULTS	Generic tacrolimus did not meet the bioequivalence criteria ; the area under the curve ( 0-12 ) ratio of generic-original tacrolimus formulation was 1.17 ( 90 % confidence interval , 1.10-1 .23 ) and the Cmax ratio was 1.49 ( 90 % confidence interval , 1.35-1 .65 ) .
RESULTS	The generic formulation also showed a shorter time to C ( max ) ( T ( max ) ) ( P = 0.04 ) .
RESULTS	Importantly , the lack of bioequivalence was not reflected in the standard monitoring parameter , trough concentrations ( P = 0.80 ) .
CONCLUSIONS	Generic tacrolimus ( Tacni ) was not found to be bioequivalent to the original formulation in elderly renal transplant recipients .
CONCLUSIONS	The significantly higher systemic exposure of tacrolimus , despite similar trough concentrations , may in the long run increase the risk of adverse effects .

###24877143
OBJECTIVE	Autoimmune rheumatic diseases ( ARD ) are characterized by systemic inflammation and may affect multiple organs and cause vascular events such as ischemic stroke and acute myocardial infarction .
OBJECTIVE	However , the association between ARD and increased risk of dementia is uncertain .
OBJECTIVE	This is a retrospective cohort study to investigate and compare the risk of dementia between patients clinically diagnosed with ARD and non-ARD patients during a 5-year follow-up period .
METHODS	Data were obtained from the Longitudinal Health Insurance Database 2000 ( LHID2000 ) .
METHODS	We included 1221 patients receiving ambulatory or hospitalization care and 6105 non-ARD patients ; patients were matched by sex , age , and the year of index use of health care .
METHODS	Each patient was studied for 5 years to identify the subsequent manifestation of dementia .
METHODS	The data obtained were analyzed by Cox proportional hazard regression .
RESULTS	During the 5-year follow-up period , 30 ARD ( 2.48 % ) and 141 non-ARD patients ( 2.31 % ) developed dementia .
RESULTS	During the 5-year follow-up period , there were no significant differences in the risks of any type of dementia ( adjusted hazard ratio ( HR ) , 1.18 ; 95 % CI , 0.79-1 .76 ) in the ARD group after adjusting for demographics and comorbidities .
CONCLUSIONS	Within the 5-year period , patients with and without ARD were found to have similar risks of developing dementia .

###24808486
BACKGROUND	The high consumption of low-fat and nonfat dairy products is associated with reduced risk of high blood pressure .
OBJECTIVE	We aimed to investigate whether the solitary addition of nonfat dairy products to the normal routine diet was capable of lowering blood pressure in middle-aged and older adults with elevated blood pressure .
METHODS	With the use of a randomized , crossover intervention-study design , 49 adults ( 56 % women ) with elevated blood pressure ( mean SEM age : 53 2 y ; systolic blood pressure : 135 1 ; diastolic blood pressure : 80 1 mm Hg ) underwent a high-dairy condition ( +4 servings conventional nonfat dairy products/d ) and isocaloric no-dairy condition ( +4 servings fruit products/d ) in which all dairy products were removed .
METHODS	Both dietary conditions lasted 4 wk with a 2-wk washout before crossing over into the alternate condition .
RESULTS	The high-dairy condition produced reductions in systolic blood pressure ( 135 1 to 127 1 mm Hg ) and pulse pressure ( 54 1 to 48 1 mm Hg ) ( both P < 0.05 ) .
RESULTS	The hypotensive effects were observed within 3 wk after the initiation of the dietary intervention and in both casual seated and ambulatory ( 24-h ) measurements ( P < 0.05 ) .
RESULTS	Pulse pressure was increased after the removal of all dairy products in the no-dairy condition ( 54 1 to 56 1 mm Hg ; P < 0.05 ) .
RESULTS	There were no changes in diastolic blood pressure after either dietary condition .
CONCLUSIONS	We concluded that the solitary manipulation of conventional dairy products in the normal routine diet would modulate blood pressure in middle-aged and older adults with prehypertension and hypertension .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01577030 .

###24378525
BACKGROUND	Potent antibody depletion techniques have paved the way to successful ABO-incompatible transplantation .
BACKGROUND	Considering its efficiency regarding IgG removal , the use of non-antigen-specific semi-selective immunoadsorption ( IA ) has been advocated .
BACKGROUND	One attractive strategy to overcome the caveat of incomplete IgM depletion and to interfere with complement activation could be the adjunctive use of membrane filtration ( MF ) to enhance the removal of macromolecules .
METHODS	To investigate the depletion efficiency of semi-selective IA plus MF , we conducted a randomized , controlled , cross-over trial including patients on regular IA treatment for indications outside recipient desensitization .
METHODS	According to the results of sample size calculation , 14 subjects were enrolled .
METHODS	Two treatment sequences , a single session of IA plus MF followed by IA alone after 7 days ( and vice versa ) , were analysed .
RESULTS	IA plus MF markedly enhanced the median per cent reduction of ABO-specific IgM determined by flow cytometry ( primary end point ; 59 versus 23 % , P < 0.001 ) and haemagglutination ( 2 versus 1 titre steps , P < 0.001 ) , respectively .
RESULTS	Combined treatment also substantially lowered C1q concentrations ( 86 versus 58 % reduction , P < 0.001 ) and the functionality of classical complement as reflected by impaired in vitro C3 activation capability .
RESULTS	IgG was strongly reduced without any additional effect of MF .
CONCLUSIONS	We demonstrate that the innovative strategy of combining MF with semi-selective IA may substantially increase IgM elimination and affect classical complement activation .
CONCLUSIONS	Our findings suggest that this new treatment concept could be an efficient strategy for recipient desensitization in ABO - and HLA-incompatible transplantation .

###24313663
OBJECTIVE	This study examined the effect of brief functional relaxation ( FR ) training on needle anxiety ( NA ) during vaccinations .
METHODS	From October 2010 through May 2012 , 48 undergraduates were recruited through the psychology research participant pool .
METHODS	Students ( N = 48 ) were randomly assigned to a 15-minute brief FR session delivered via MP3 player or a standard care condition ( 15 minutes of sitting quietly ) prior to receiving injections at the immunization clinic .
METHODS	Measures were completed before ( T1 ) and after ( T2 ) the assigned condition , assessing expected NA , state anxiety , blood pressure , and heart rate ; and after the injection ( T3 ) , self-reported NA during the injection .
RESULTS	Unexpectedly , the groups did not differ at T2 .
RESULTS	However , during the injection , brief FR participants indicated lower self-reported NA ( T3 ) than standard care .
CONCLUSIONS	Brief FR is a simple , inexpensive technique that may reduce NA in college health settings and help decrease delays in treatment seeking .

###25554550
BACKGROUND	Little is known about the relationship between body temperature and outcomes in patients with acute respiratory distress syndrome ( ARDS ) .
BACKGROUND	A better understanding of this relationship may provide evidence for fever suppression or warming interventions , which are commonly applied in practice .
OBJECTIVE	To examine the relationship between body temperature and mortality in patients with ARDS .
METHODS	Secondary analysis of body temperature and mortality using data from the ARDS Network Fluid and Catheter Treatment Trial ( n = 969 ) .
METHODS	Body temperature at baseline and on study day 2 , primary cause of ARDS , severity of illness , and 90-day mortality were analyzed by using multiple logistic regression .
RESULTS	Mean baseline temperature was 37.5 C ( SD , 1.1 C ; range , 27.2C-40 .7 C ) .
RESULTS	At baseline , fever ( 38.3 C ) was present in 23 % and hypothermia ( < 36C ) in 5 % of the patients .
RESULTS	Body temperature was a significant predictor of 90-day mortality after primary cause of ARDS and score on the Acute Physiology and Chronic Health Evaluation III were adjusted for .
RESULTS	Higher temperature was associated with decreased mortality : for every 1C increase in baseline temperature , the odds of death decreased by 15 % ( odds ratio , 0.85 ; 95 % CI , 0.73-0 .98 , P = .03 ) .
RESULTS	When patients were divided into 5 temperature groups , mortality was lower with higher temperature ( P for trend = .02 ) .
CONCLUSIONS	Early in ARDS , fever is associated with improved survival rates .
CONCLUSIONS	Fever in the acute phase response to lung injury and its relationship to recovery may be an important factor in determining patients ' outcome and warrants further study .

###24325649
OBJECTIVE	Endoscopic examinations carry a potential risk of cross-infection , and the traditional reprocessing method is time consuming .
OBJECTIVE	We evaluated the safety and efficacy of a novel disposable sheathed gastroscope system in clinical practice in comparison with the conventional gastroscope .
METHODS	There were two phases in the study .
METHODS	In phase 1 , 20 patients with hepatitis B were randomized into two groups : the sheathed group was examined with the novel disposable sheathed gastroscope ( n = 10 ) and the conventional group with the conventional gastroscope ( n = 10 ) .
METHODS	Microbiologic tests were performed on each endoscope afterwards .
METHODS	In the second phase , 1120 patients were randomized again into the same two groups with 568 and 552 patients in the sheathed group and the conventional group , respectively .
METHODS	The time duration of the endoscopic procedure and reprocessing were measured .
METHODS	The pathology detection rate of endoscopic examinations , the patients ' subjective feelings , and problems occurred during procedures were also recorded .
RESULTS	The total instrument turn-around time in the phase 2 sheathed group ( 9.9 1.3 min ) was significantly shorter than the conventional group ( 39.0 1.4 min , P = 0.000 ) .
RESULTS	The mean procedural time was slightly longer in the sheathed group than in the conventional group ( 4.9 1.4 vs 4.1 1.3 min , P = 0.000 ) .
RESULTS	However , the duration of endoscopic reprocessing was much shorter ( 4.9 0.2 vs 35 0.2 min , P = 0.000 ) .
RESULTS	No significant differences were observed in patient discomfort , optical clarity , or pathology detection rate .
RESULTS	There were no complications in either group , and no microbial contamination was detected in phase 1 of the study .
CONCLUSIONS	Compared with the conventional gastroscope , the novel disposable sheathed gastroendoscope is safe and more efficient in clinical practice .

###24770406
OBJECTIVE	To evaluate the outcome of the non-skin thinning technique as compared with the thinning technique 5 years after surgical implantation of bone-anchored hearing `` devices . ''
METHODS	A single-center , 5-year retrospective follow-up study was designed to evaluate the novel surgical technique without skin thinning as compared to conventional techniques .
METHODS	Eligible patients were consecutively operated on 5 years earlier in a test group without thinning and in two control groups with thinning .
METHODS	In the first control group , a flap technique was used , whereas in the second control group a dermatome technique was used and age-matched patients were selected .
METHODS	Thirty-six patients were operated on with a single-step surgery under local anesthesia .
METHODS	In the test group ( non-skin thinning technique ) , 12 patients were operated on with a linear incision using an 8.5-mm abutment .
METHODS	In the control groups ( flap and dermatome techniques , 12 patients in each group ) , the standard protocol with skin thinning was used with a 5.5-mm abutment .
RESULTS	Throughout the 5-year span under review , the non-skin thinning test group exhibited good preservation of tissue with decreased skin reactions and no adverse events .
RESULTS	The time required for surgery without skin thinning was reduced to approximately 10 to 15 minutes and the cosmetic outcome after 5 years was improved .
RESULTS	Numbness and peri-implant infections were minimal in the surrounding skin area for patients who underwent surgery without thinning .
CONCLUSIONS	This 5-year follow-up study demonstrates that percutaneous osseointegrated implantation without skin thinning is safe and has a better outcome than implantation with skin thinning .

###25205231
BACKGROUND	The two primary residential options for older adults who require supportive care are nursing homes and residential care/assisted living .
BACKGROUND	More than one-quarter of all deaths in the U.S. occur in these settings .
BACKGROUND	Although the information available on end of life in long-term care has been growing , the comparative suitability of various measures to guide this work is unknown .
OBJECTIVE	To determine the optimal measures to assess end-of-life care and outcomes in nursing homes and residential care/assisted living .
METHODS	A total of 264 family members of decedents from 118 settings were interviewed and provided data on 11 instruments that have been used in , but not necessarily developed for , long-term care populations ; Overall , 20 scales and subscales/indices were evaluated .
METHODS	Measures were compared on their psychometric properties and the extent to which they discriminated among important resident , family , and setting characteristics .
RESULTS	Prioritizing measures that distinguish the assessment of care from the assessment of dying , and secondarily thatexhibit an acceptable factor structure , this study recommends two measures of care-the Family Perceptions of Physician-Family Caregiver Communication and the End of Life in Dementia ( EOLD ) - Satisfaction With Care-and two measures of outcomes-the EOLD-Symptom Management and the EOLD-Comfort Assessment in Dying .
RESULTS	An additional measure to assess outcomes is the Mini-Suffering State Examination ( MSSE ) .
RESULTS	The care measures and the MSSE are especially valuable as they discriminate between decedents who were and were not transferred immediately before death , an important outcome , and whether the family expected the death , a useful target for intervention .
CONCLUSIONS	Despite these recommendations , measurement selection should be informed not only on the basis of psychometric properties but also by specific clinical and research needs .
CONCLUSIONS	The data in this manuscript will help researchers , clinicians , and administrators understand the implications of choosing various measures for their work .

###25632745
OBJECTIVE	To explore the effect of Tongfu Jinghua Decoction ( TJD ) on hemodynamics and tissue oxygen metabolism in patients with post-traumatic sepsis shock .
METHODS	Totally 60 patients were randomly assigned to the treatment group and the control group , 30 in each group .
METHODS	Patients in the treatment group took TJD or were administered with TJD by nasal feeding in combined with conventional Western medical treatment , while patients in the control group only received conventional Western medical treatment .
METHODS	Changes of each index in hemodynamics and tissue oxygen metabolism were observed before treatment , and at 6 , 12 , 24 , and 48 h after treatment .
RESULTS	Compared with before treatment in the same group , hemodynamic changes were significantly improved at each time point in the two groups .
RESULTS	All indices of tissue oxygen metabolism at each time point of the two groups were significantly improved , except changes of O2 extraction ratio ( ER ) after treatment in the control group ( P < 0.05 , P < 0.01 ) .
RESULTS	Compared with the control group in the same period , heart rate ( HR ) , systemic vascular resist - ance ( SVR ) , and cardiac output ( CO ) were significantly improved with statistical difference ( P < 0.05 , P < 0.01 ) .
RESULTS	Mean arterial pressure ( MAP ) , central venous pressure ( CVP ) , and cardiac index ( CI ) were significantly improved at 6 , 12 , and 24 h after treatment with statistical difference ( P < 0.05 , P < 0.01 ) .
RESULTS	Each index of tissue oxygen metabolism in the treatment group were all improved at each time point with statistical difference ( P < 0.05 , P < 0.01 ) .
CONCLUSIONS	TJD combined with conventional Western medical treatment could quickly improve hemodynamics and tissue oxygen metabolism disorder in patients with septic shock , and its curative effect was superior to that of conventional Western medical treatment alone .

###25006720
BACKGROUND	In the Total Body Hypothermia for Neonatal Encephalopathy Trial ( TOBY ) , newborns with asphyxial encephalopathy who received hypothermic therapy had improved neurologic outcomes at 18 months of age , but it is uncertain whether such therapy results in longer-term neurocognitive benefits .
METHODS	We randomly assigned 325 newborns with asphyxial encephalopathy who were born at a gestational age of 36 weeks or more to receive standard care alone ( control ) or standard care with hypothermia to a rectal temperature of 33 to 34C for 72 hours within 6 hours after birth .
METHODS	We evaluated the neurocognitive function of these children at 6 to 7 years of age .
METHODS	The primary outcome of this analysis was the frequency of survival with an IQ score of 85 or higher .
RESULTS	A total of 75 of 145 children ( 52 % ) in the hypothermia group versus 52 of 132 ( 39 % ) in the control group survived with an IQ score of 85 or more ( relative risk , 1.31 ; P = 0.04 ) .
RESULTS	The proportions of children who died were similar in the hypothermia group and the control group ( 29 % and 30 % , respectively ) .
RESULTS	More children in the hypothermia group than in the control group survived without neurologic abnormalities ( 65 of 145 [ 45 % ] vs. 37 of 132 [ 28 % ] ; relative risk , 1.60 ; 95 % confidence interval , 1.15 to 2.22 ) .
RESULTS	Among survivors , children in the hypothermia group , as compared with those in the control group , had significant reductions in the risk of cerebral palsy ( 21 % vs. 36 % , P = 0.03 ) and the risk of moderate or severe disability ( 22 % vs. 37 % , P = 0.03 ) ; they also had significantly better motor-function scores .
RESULTS	There was no significant between-group difference in parental assessments of children 's health status and in results on 10 of 11 psychometric tests .
CONCLUSIONS	Moderate hypothermia after perinatal asphyxia resulted in improved neurocognitive outcomes in middle childhood .
CONCLUSIONS	( Funded by the United Kingdom Medical Research Council and others ; TOBY ClinicalTrials.gov number , NCT01092637 . )

###25678773
OBJECTIVE	To evaluate the effectiveness and safety of 0.3 % sodium hyaluronate ( HA ) compared to recombinant bovine basic fibroblast growth factor ( rb-bFGF ) for the treatment of corneal epithelial abrasion caused by mechanical damage in Chinese patients .
METHODS	Thirty patients were randomly assigned to the HA or rb-bFGF treatment group .
METHODS	The HA group was treated with 0.3 % HA and 0.5 % levofloxacin , and the rb-bFGF group was treated with topical rb-bFGF and 0.5 % levofloxacin .
METHODS	The primary endpoint was the clinical effectiveness rates at day 3 .
METHODS	Secondary endpoints were the dimensions of the wound area and the percentage of wound closure .
RESULTS	After 3 days of treatment , the clinical effectiveness rates of the HA group and the rb-bFGF group were 86.67 % ( 13/15 ) and 93.33 % ( 14/15 ) , respectively .
RESULTS	The dimensions of the wound area were reduced from 9.838.50 to 0.020.06 mm ( 2 ) for the HA group at day 7 , and from 10.589.94 to 0.020.07 mm ( 2 ) for the rb-bFGF group .
RESULTS	At day 3 , the wound closure was almost complete in both groups ; 94.73 % in the HA group compared to 95.77 % in the rb-bFGF group ( P > 0.05 ) .
CONCLUSIONS	Topical 0.3 % HA provided a promising treatment for superficial corneal abrasion caused by mechanical damage in a manner similar to rb-bFGF .

###25335376
BACKGROUND	To identify the determinants of recurrence following primary pterygium excision combined with conjunctival autograft ( CAG ) and intraoperative use of Mitomycin C ( MMC ) or 5-Fluorouracil ( 5-FU ) .
METHODS	A randomized controlled clinical trial comparing 5-FU ( 50 mg/ml ) plus CAG versus MMC ( 0.01 % ) plus CAG in preventing recurrence of primary pterygium following excision .
RESULTS	A total of 80 eyes of 80 subjects were studied , with 46 eyes in the 5-FU group and 34 eyes in the MMC group .
RESULTS	The mean age was 50.7 + / - 13.1 years with a male : female ratio of 0.95:1 .
RESULTS	Mean follow up period was 35.2 + / - 29.1 weeks .
RESULTS	The overall recurrence rate was 10 % , with a rate of 8.7 % in the 5-FU group and 11.8 % in the MMC group .
RESULTS	The mean age of the patients who had a recurrence was 38.1 + / - 13.3 years compared to 52.1 + / - 12.4 years in those without a recurrence ( p = 0.003 ) .
RESULTS	The median size of the pterygium in patients who had a recurrence was 3.2 mm , while the median size in patients who did not have a recurrence was 3.0 mm ( p = 0.8 ) .
RESULTS	Five ( 12.8 % ) males had a recurrence compared to three ( 7.3 % ) females ( p = 0.48 ) ; while 10.5 % of fleshy pterygia recurred compared to none ( 0 % ) of the non-fleshy pterygia ( p = 1.00 ) .
CONCLUSIONS	Younger age remains a risk factor for recurrence when both CAG and antimetabolites are combined in the treatment of pterygium , while the effect of gender , size and morphology of the pterygium may be diminished by such combination .

###24727884
OBJECTIVE	The optimal platelet inhibition strategy for ACS patients managed without revascularization is unknown .
OBJECTIVE	We aimed to evaluate efficacy and safety of ticagrelor vs. clopidogrel in the non-ST-elevation acute coronary syndrome ( NSTE-ACS ) subgroup of the PLATO trial , in the total cohort , and in the subgroups managed with and without revascularization within 10 days of randomization .
RESULTS	We performed a retrospective analysis of the primary endpoint of cardiovascular death/myocardial infarction/stroke .
RESULTS	Among 18 624 PLATO patients , 11 080 ( 59 % ) were categorized as NSTE-ACS at randomization .
RESULTS	During the initial 10 days , 74 % had angiography , 46 % PCI , and 5 % CABG .
RESULTS	In NSTE-ACS patients , the primary endpoint was reduced with ticagrelor vs. clopidogrel [ 10.0 vs. 12.3 % ; hazard ratio ( HR ) 0.83 ; 95 % confidence interval ( CI ) = 0.74-0 .93 ] , as was myocardial infarction ( 6.6 vs. 7.7 % ; HR 0.86 ; 95 % CI = 0.74-0 .99 ) , cardiovascular death ( 3.7 vs. 4.9 % ; HR 0.77 ; 95 % CI = 0.64-0 .93 ) , and all-cause death ( 4.3 vs. 5.8 % ; HR 0.76 ; 95 % CI = 0.64-0 .90 ) .
RESULTS	Major bleeding rate was similar between treatment groups ( 13.4 vs. 12.6 % ; HR 1.07 ; 95 % CI = 0.95-1 .19 ) , but ticagrelor was associated with an increase in non-CABG major bleeding ( 4.8 vs. 3.8 % ; HR 1.28 ; 95 % CI = 1.05-1 .56 ) .
RESULTS	Within the first 10 days , 5366 ( 48.4 % ) patients were managed without revascularization .
RESULTS	Regardless of revascularization or not , ticagrelor consistently reduced the primary outcome ( HR 0.86 vs. 0.85 , interaction P = 0.93 ) , and all-cause death ( HR 0.75 vs. 0.73 , interaction P = 0.89 ) with no significant increase in overall major bleeding .
CONCLUSIONS	In patients with NSTE-ACS , benefit of ticagrelor over clopidogrel in reducing ischaemic events and total mortality was consistent with the overall PLATO trial , independent of actually performed revascularization during the initial 10 days .

###25467826
BACKGROUND	Declining of eradication rates for Helicobacter pylori in Korea may be partly from the increasing prevalence of antibiotic resistance , especially clarithromycin resistance .
OBJECTIVE	To compare the efficacy and the safety of using 10-day standard sequential therapy and levofloxacin-containing sequential therapy as a first-line treatment for Helicobacter pylori eradication in Korea .
METHODS	A total of 200 patients with proven Helicobacter pylori infection randomly received 10-day standard sequential therapy ( n = 100 ) or levofloxacin-containing sequential therapy ( n = 100 ) .
METHODS	The standard sequential therapy group received rabeprazole and amoxicillin for 5 days , followed by rabeprazole , clarithromycin , and metronidazole for 5 more days .
METHODS	The levofloxacin-containing sequential therapy group was treated with rabeprazole and amoxicillin for 5 days , followed by rabeprazole , levofloxacin , and metronidazole for 5 more days .
RESULTS	Intention-to-treat eradication rates were 79.0 % and 78.0 % for groups of standard sequential and levofloxacin-containing sequential therapy , respectively ( P = 0.863 ) .
RESULTS	Per-protocol eradication rates were 84.9 % and 81.3 % , respectively , for these two therapies ( P = 0.498 ) .
RESULTS	There were no significant differences between the groups in regard to the eradication rates and adverse events .
CONCLUSIONS	The 10-day levofloxacin-containing sequential regimen and the standard sequential regimen showed the similar eradication rates of Helicobacter pylori in Korea .

###24557111
BACKGROUND	We investigated whether individualized positive end-expiratory pressure ( PEEP ) improves oxygenation , ventilation , and lung mechanics during one-lung ventilation compared with standardized PEEP .
METHODS	Thirty patients undergoing thoracic surgery were randomly allocated to the study or control group .
METHODS	Both groups received an alveolar recruitment maneuver at the beginning and end of one-lung ventilation .
METHODS	After the alveolar recruitment maneuver , the control group had their lungs ventilated with a 5 cmH2O PEEP , while the study group had their lungs ventilated with an individualized PEEP level determined by a PEEP decrement trial .
METHODS	Arterial blood samples , lung mechanics , and volumetric capnography were recorded at multiple timepoints throughout the procedure .
RESULTS	The individualized PEEP values in study group were higher than the standardized PEEP values ( 10 2 vs 5 cmH2O ; P < 0.001 ) .
RESULTS	In both groups , arterial oxygenation decreased when bilateral-lung ventilation was switched to one-lung ventilation and increased after the alveolar recruitment maneuver .
RESULTS	During one-lung ventilation , oxygenation was maintained in the study group but decreased in the control group .
RESULTS	After one-lung ventilation , arterial oxygenation was significantly higher in the study group ( 306 vs 231 mmHg , P = 0.007 ) .
RESULTS	Static compliance decreased in both groups when bilateral-lung ventilation was switched to one-lung ventilation .
RESULTS	Static compliance increased significantly only in the study group ( P < 0.001 ) after the alveolar recruitment maneuver and optimal PEEP adjustment .
RESULTS	The alveolar recruitment maneuver did not decrease cardiac index in any patient .
CONCLUSIONS	During one-lung ventilation , the improvements in oxygenation and lung mechanics after an alveolar recruitment maneuver were better preserved by ventilation by using individualized PEEP with a PEEP decrement trial than with a standardized 5 cmH2O of PEEP .

###25304364
BACKGROUND	Alzheimer 's disease , a global public health issue , accounts for 60 to 80 % of all dementias .
BACKGROUND	Alzheimer 's disease primarily causes cognitive impairment and drugs have only modest short-term effects , highlighting a pressing need to develop effective interventions .
BACKGROUND	Aerobic exercise holds promise for treating cognitive impairment in Alzheimer 's disease through biologically sound mechanisms .
BACKGROUND	Nonetheless , aerobic exercise studies in Alzheimer 's disease are limited with mixed findings .
METHODS	This pilot randomized controlled trial will investigate the effects of a 6-month , individualized , moderate-intensity cycling intervention ( 20 to 50 minutes per session , 3 times a week ) on cognition and hippocampal volume in community-dwelling older adults with mild-to-moderate Alzheimer 's disease .
METHODS	The specific aims are to : 1 ) determine the immediate effect of the cycling intervention on cognition in Alzheimer 's disease ; 2 ) examine if the cycling intervention slows cognitive decline in Alzheimer 's disease from baseline to 12 months ; and 3 ) assess the effect of aerobic exercise on hippocampal volume over 12 months .
METHODS	Ninety subjects will be randomized on a 2:1 allocation ratio to cycling or attention control ( low-intensity stretching ) and followed for another 6 months .
METHODS	Allocations will be concealed to all investigators and outcome assessors will be blinded to group assignments and previous data .
METHODS	Cognition will be measured by the Alzheimer 's disease Assessment Scale-Cognition at baseline before randomization and at 3 , 6 , 9 , and 12 months .
METHODS	Hippocampal volume will be measured by magnetic resonance imaging at baseline and 6 and 12 months .
METHODS	The sample size of 90 will give 80 % power to detect a 2.5-point difference in within-group changes in the Alzheimer 's disease Assessment Scale-Cognition at 6 months for the cycling group .
CONCLUSIONS	Findings from this study will address the critical gap of exercise efficacy in Alzheimer 's disease and use of magnetic resonance imaging as an outcome measure in clinical trials .
CONCLUSIONS	This study will provide a potential treatment that may increase physical function and quality of life and curb the prohibitive costs for the growing dementia population .
BACKGROUND	Primary registration : ( NCT01954550 ; date of registration : 20 September 2013 ) .
BACKGROUND	Secondary registration : ( NCT01954550 ; date of registration : 1 October 2013 ) .

###25046948
OBJECTIVE	To observe the primary prevention role of Wuling Capsule ( WC ) on poststroke depression ( PSD ) patients .
METHODS	Acute stroke patients were recruited and randomized into 2 groups by stratification , 55 in each group .
METHODS	All patients received same routine treatment of cardiovascular diseases .
METHODS	Patients in the experimental group additionally took WC ( 0.33 g each pill ) , 3 pills per day , three times per day ; while those in the control group additionally took placebos , 3 pills per day , three times per day .
METHODS	Two weeks consisted of one therapeutic course .
METHODS	The diagnosis of PSD was performed once every other week .
METHODS	Those in accordance with PSD diagnosis discontinued any drug therapy .
METHODS	Those not in accordance with PSD diagnosis continued the drug therapy for 1-12 therapeutic course ( s ) ( in total of 6 months ) .
METHODS	If they were still not in accordance with PSD diagnosis , then they discontinued the drug therapy .
METHODS	The morbidity of PSD , the average time of depression occurrence , Hamilton depression rating scale ( HAMD ) score , and adverse reactions were observed .
RESULTS	The 1 - , 3 - , and 6-month morbidity of PSD was 8 % , 16 % , and 34 % in the experimental group , while they were 19.6 % , 29.4 % , and 54.9 % in the control group .
RESULTS	The occurrence rate was lower in the experimental group than in the control group .
RESULTS	Besides , there was statistical difference in the 6-month occurrence rate between the two groups ( chi2 = 4.465 , P < 0.05 ) .
RESULTS	The average time of PSD occurrence was longer in the experimental group than in the control group ( 14.96 + / - 8.31 weeks vs. 9.36 + / - 6.06 weeks ; t = 6.762 , P < 0.05 ) .
RESULTS	The HAMD score at the PSD occurrence was 11.96 + / - 2.14 in the experimental group , lower than that of the control group ( 14.57 + / - 4.24 ) , showing statistical difference ( t = 5.641 , P < 0.05 ) .
CONCLUSIONS	WC was superior to the placebos in lowering the incidence of PSD , delaying the occurrence time of PSD , attenuating the depression degree of PSD , and had certain preventive effect on the incidence of PSD .

###24351126
BACKGROUND	Collective caregiving , performed by caregivers working in pairs ( informal primary and secondary caregivers working together ) , is common in the hospice setting .
BACKGROUND	Research suggests that caregiving pairs may experience different caregiver outcomes .
BACKGROUND	However , little is known about how caregiving pairs differ from solo caregivers ( informal primary caregivers ) on outcome measures .
OBJECTIVE	The goal of this study was to determine whether being in a caregiver pair affected caregiver anxiety and depression and how outcomes changed over time .
METHODS	A mixed model analysis was used .
METHODS	Hospice caregivers ( 260 solo caregivers and 44 caregivers in 22 pairs ) who participated in a larger , randomized controlled trial completed caregiver measures upon hospice admission and periodically until the death of the patient or hospice decertification .
METHODS	Measured were caregiver quality of life , social support , anxiety , and depression .
RESULTS	Caregiver pairs had higher anxiety and depression scores than solo caregivers .
RESULTS	Emotional , financial , and physical quality of life were associated with decreased depression , whereas only emotional and financial quality of life were correlated with lower levels of anxiety .
RESULTS	Social support was associated with lower levels of depression and anxiety .
CONCLUSIONS	Despite assumptions that social support is positively facilitated vis-a-vis collective caregiving , caregiving pairs may be at higher risk for anxiety and depression .
CONCLUSIONS	Future research is needed to address why individuals become anxious and/or depressed when working as part of a caregiving pair .

###24267861
BACKGROUND	Delayed antibiotic prescribing is an effective method of reducing the consumption of antibiotics for respiratory tract infections ( RTIs ) .
BACKGROUND	However , interventions to promote its use remain unexplored .
OBJECTIVE	To measure the effects of a GP educational intervention and a computer delayed-prescribing pop-up reminder on antibiotic-dispensing rates .
OBJECTIVE	The study also aimed to identify factors influencing GPs ' decisions to issue delayed prescriptions and patients ' decisions to fill their prescriptions .
METHODS	Controlled trial nested within a cluster-randomised controlled trial in urban and rural practices in 11 counties in southern Norway .
METHODS	Educational intervention and control groups were randomly populated from 81 continuing medical education groups .
METHODS	Within the intervention arm , 107 of the 156 participating GPs were assigned , based on the electronic patient-record system they used , to having a pop-up reminder installed on their computers .
METHODS	Data on prescribed and dispensed antibiotics from 1 year before , and 1 year during , the intervention were collected and linked .
RESULTS	Valid data were obtained from 328 GPs ( 75 % ) .
RESULTS	At baseline , 92.1 % of prescriptions were filled at pharmacies .
RESULTS	The effect of the educational intervention was a 1 % reduction in approximated risk ( risk ratio [ RR ] 0.99 , 95 % confidence interval [ CI ] = 0.96 to 1.01 ) of antibiotics being dispensed , while the combined effect of the educational and pop-up reminder intervention was a 4 % reduction in approximated risk ( RR 0.96 , 95 % CI = 0.94 to 0.98 ) .
RESULTS	In the pop-up intervention group , 11.0 % of the prescriptions were issued as delayed prescriptions and 59.2 % of these were filled .
RESULTS	Upper RTI , sinusitis , and otitis gave highest odds for delayed prescribing and lowest odds for dispensing .
CONCLUSIONS	Promoting delayed prescribing among GPs results in a small decrease in antibiotic dispensing .
CONCLUSIONS	The savings potential is greatest for upper RTI , sinusitis , and otitis .

###25097243
OBJECTIVE	To study eye movements in a large group of children after the removal of unilateral infantile cataract , and to compare fixation instabilities between treatment groups with or without IOL implantation .
METHODS	The Infant Aphakia Treatment Study ( IATS ) is a randomized , multicenter clinical trial comparing IOL to contact lens ( CL ) treatment with a unilateral infantile cataract in participants who underwent cataract surgery at 1 to 6 months of age .
METHODS	At age 4.5 years , eye movements were recorded in 103 participants , using a high-speed video camera while the child performed a fixation task .
METHODS	The recordings were inspected by masked readers for the presence of fixation instabilities ( nystagmus and saccadic oscillations ) .
RESULTS	Overall , fixation instabilities were observed in 50 ( 60 % ) of 83 children who had evaluable recordings , with no differences between treatment groups ( 27 [ 64 % ] of 42 in the IOL group , 23 [ 56 % ] of 41 in the CL group ; P = 0.51 ) .
RESULTS	Nystagmus was seen in 38 % and saccadic oscillations in 31 % , with no differences between treatment groups ( P > 0.33 ) .
RESULTS	Children without a fixation instability had better visual acuity ( P = 0.04 ) .
CONCLUSIONS	Nystagmus and saccadic oscillations are well-known consequences of infantile cataracts , presumably the result of visual deprivation during the critical period of visual development .
CONCLUSIONS	After early cataract extraction , successful optical correction may reduce further form deprivation and minimize the incidence of these fixation instabilities .
CONCLUSIONS	In this study , no differences in the presence of fixation instabilities were found between the two treatment strategies ( CL or IOL ) for optical correction after cataract removal .
CONCLUSIONS	( ClinicalTrials.gov number , NCT00212134 . )

###25841622
OBJECTIVE	This report presents the analysis of the RTOG 0537 multicenter randomized study that compared acupuncture-like transcutaneous stimulation ( ALTENS ) with pilocarpine ( PC ) for relieving radiation-induced xerostomia .
METHODS	Eligible patients were randomized to twice-weekly 20-minute ALTENS sessions for 24 sessions during 12weeks or PC ( 5mg 3 times daily for 12weeks ) .
METHODS	The primary endpoint was the change in the University of Michigan Xerostomia-Related Quality of Life Scale ( XeQOLS ) scores from baseline to 9months from randomization ( MFR ) .
METHODS	Secondary endpoints included basal and citric acid primed whole salivary production ( WSP ) , ratios of positive responders ( defined as patients with 20 % reduction in overall radiation-induced xerostomia symptom burden ) , and the presence of adverse events based on the Common Terminology Criteria for Adverse Events version 3 .
METHODS	An intention-to-treat analysis was conducted .
RESULTS	One hundred forty-eight patients were randomized .
RESULTS	Only 96 patients completed the required XeQOLS and were evaluable at 9 MFR ( representing merely 68.6 % statistical power ) .
RESULTS	Seventy-six patients were evaluable at 15 MFR .
RESULTS	The median change in the overall XeQOLS in ALTENS and PC groups at 9 and 15 MFR were -0.53 and -0.27 ( P = .45 ) and -0.6 and -0.47 ( P = .21 ) .
RESULTS	The corresponding percentages of positive responders were 81 % and 72 % ( P = .34 ) and 83 % and 63 % ( P = .04 ) .
RESULTS	Changes in WSP were not significantly different between the groups .
RESULTS	Grade 3 or less adverse events , mostly consisting of grade 1 , developed in 20.8 % of patients in the ALTENS group and in 61.6 % of the PC group .
CONCLUSIONS	The observed effect size was smaller than hypothesized , and statistical power was limited because only 96 of the recruited 148 patients were evaluable .
CONCLUSIONS	The primary endpoint-the change in radiation-induced xerostomia symptom burden at 9 MFR-was not significantly different between the ALTENS and PC groups .
CONCLUSIONS	There was significantly less toxicity in patients receiving ALTENS .

###25388563
BACKGROUND	Current interventions for haemorrhoidal disease include traditional haemorrhoidectomy ( TH ) and stapled haemorrhoidopexy ( SH ) surgery .
BACKGROUND	However , uncertainty remains as to how they compare from a clinical , quality of life ( QoL ) and economic perspective .
BACKGROUND	The study is therefore designed to determine whether SH is more effective and more cost-effective , compared with TH .
METHODS	eTHoS ( either Traditional Haemorrhoidectomy or Stapled Haemorrhoidopexy for Haemorrhoidal Disease ) is a pragmatic , multicentre , randomised controlled trial .
METHODS	Currently , 29 secondary care centres are open to recruitment .
METHODS	Patients , aged 18 year or older , with circumferential haemorrhoids grade II to IV , are eligible to take part .
METHODS	The primary clinical and economic outcomes are QoL profile ( area under the curve derived from the EuroQol Group 's 5 Dimension Health Status Questionnaire ( EQ-5D ) at all assessment points ) and incremental cost per quality adjusted life year ( QALY ) based on the responses to the EQ-5D at 24 months .
METHODS	The secondary outcomes include a comparison of the SF-36 scores , pain and symptoms sub-domains , disease recurrence , complication rates and direct and indirect costs to the National Health Service ( NHS ) .
METHODS	A sample size of n = 338 per group has been calculated to provide 90 % power to detect a difference in the mean area under the curve ( AUC ) of 0.25 standard deviations derived from EQ-5D score measurements , with a two-sided significance level of 5 % .
METHODS	Allowing for non-response , 400 participants will be randomised per group .
METHODS	Randomisation will utilise a minimisation algorithm that incorporates centre , grade of haemorrhoidal disease , baseline EQ-5D score and gender .
METHODS	Blinding of participants and outcome assessors is not attempted .
CONCLUSIONS	This is one of the largest trials of its kind .
CONCLUSIONS	In the United Kingdom alone , 29,000 operations for haemorrhoidal disease are done annually .
CONCLUSIONS	The trial is therefore designed to give robust evidence on which clinicians and health service managers can base management decisions and , more importantly , patients can make informed choices .
BACKGROUND	Current Controlled Trials ISRCTN80061723 ( assigned 8 March 2010 ) .

###24579075
OBJECTIVE	The aim of the study was to assess the impact of the long-term use of the composite probiotics in patients after restorative proctocolectomy .
METHODS	Forty-three patients ( 20 females and 23 males , aged 21 to 68 years ) after restorative proctocolectomy were included in the study .
METHODS	After randomization patients were divided into placebo group and treatment group with oral intake of probiotic containing Lactobacillus acidophilus , Lactobacillus delbrueckii subsp .
METHODS	bulgaricus , and Bifidobacterium bifidus .
METHODS	Patients were investigated during initial visit and during final visit after 9 months .
METHODS	All patients were subjected to standard clinical and endoscopic examination with microscopic study of the specimens .
METHODS	Concentrations of calprotectin and pyruvate kinase isoenzyme M2-PK were determined in all cases .
RESULTS	The average severity of pouchitis and the number of patients with pouchitis significantly decrease after 9 months of the probiotic taking .
RESULTS	The concentrations of calprotectin and pyruvate kinase isoenzyme M2-PK significantly decreased after the therapy .
CONCLUSIONS	Nine months of the probiotic treatment ( Lactobacillus acidophilus , Lactobacillus delbrueckii subsp .
CONCLUSIONS	bulgaricus , and Bifidobacterium bifidus ) reduced the number of patients with pouchitis , decreased the PDAI score , and also decreased the fecal pyruvate kinase and calprotectin .
CONCLUSIONS	The long-term probiotics use is safe and well accepted and can be an effective method of the pouchitis prevention .

###24742660
OBJECTIVE	To compare the efficacy and safety of two doses of once-weekly dulaglutide , a glucagon-like peptide 1 receptor agonist , to sitagliptin in uncontrolled , metformin-treated patients with type 2 diabetes .
OBJECTIVE	The primary objective was to compare ( for noninferiority and then superiority ) dulaglutide 1.5 mg versus sitagliptin in change from baseline in glycosylated hemoglobin A1c ( HbA1c ) at 52 weeks .
METHODS	This multicenter , adaptive , double-blind , parallel-arm study randomized patients ( N = 1,098 ; mean baseline age 54 years ; HbA1c 8.1 % [ 65 mmol/mol ] ; weight 86.4 kg ; diabetes duration 7 years ) to dulaglutide 1.5 mg , dulaglutide 0.75 mg , sitagliptin 100 mg , or placebo ( placebo-controlled period up to 26 weeks ) .
METHODS	The treatment period lasted 104 weeks , with 52-week primary end point data presented .
RESULTS	The mean HbA1c changes to 52 weeks were ( least squares mean SE ) : -1.10 0.06 % ( -12.0 0.7 mmol/mol ) , -0.87 0.06 % ( 9.5 0.7 mmol/mol ) , and -0.39 0.06 % ( 4.3 0.7 mmol/mol ) for dulaglutide 1.5 mg , dulaglutide 0.75 mg , and sitagliptin , respectively .
RESULTS	Both dulaglutide doses were superior to sitagliptin ( P < 0.001 , both comparisons ) .
RESULTS	No events of severe hypoglycemia were reported .
RESULTS	Mean weight changes to 52 weeks were greater with dulaglutide 1.5 mg ( -3.03 0.22 kg ) and dulaglutide 0.75 mg ( -2.60 0.23 kg ) compared with sitagliptin ( -1.53 0.22 kg ) ( P < 0.001 , both comparisons ) .
RESULTS	The most common gastrointestinal treatment-emergent adverse events in dulaglutide 1.5 - and 0.75-mg arms were nausea , diarrhea , and vomiting .
CONCLUSIONS	Both dulaglutide doses demonstrated superior glycemic control versus sitagliptin at 52 weeks with an acceptable tolerability and safety profile .

###25497694
BACKGROUND	Four previously published randomised clinical trials have shown that tamoxifen can reduce the risk of breast cancer in healthy women at increased risk of breast cancer in the first 10 years of follow-up .
BACKGROUND	We report the long-term follow-up of the IBIS-I trial , in which the participants and investigators remain largely masked to treatment allocation .
METHODS	In the IBIS-I randomised controlled trial , premenopausal and postmenopausal women 35-70 years of age deemed to be at an increased risk of developing breast cancer were randomly assigned ( 1:1 ) to receive oral tamoxifen 20 mg daily or matching placebo for 5 years .
METHODS	Patients were randomly assigned to the two treatment groups by telephone or fax according to a block randomisation schedule ( permuted block sizes of six or ten ) .
METHODS	Patients and investigators were masked to treatment assignment by use of central randomisation and coded drug supply .
METHODS	The primary endpoint was the occurrence of breast cancer ( invasive breast cancer and ductal carcinoma in situ ) , analysed by intention to treat .
METHODS	Cox proportional hazard models were used to assess breast cancer occurrence and mortality .
METHODS	The trial is closed to recruitment and active treatment is completed , but long-term follow-up is ongoing .
METHODS	This trial is registered with controlledtrials.com , number ISRCTN91879928 .
RESULTS	Between April 14 , 1992 , and March 30 , 2001 , 7154 eligible women recruited from genetics clinics and breast care clinics in eight countries were enrolled into the IBIS-I trial and were randomly allocated to the two treatment groups : 3579 to tamoxifen and 3575 to placebo .
RESULTS	After a median follow up of 16.0 years ( IQR 14.1-17 .6 ) , 601 breast cancers have been reported ( 251 [ 7.0 % ] in 3579 patients in the tamoxifen group vs 350 [ 9.8 % ] in 3575 women in the placebo group ; hazard ratio [ HR ] 0.71 [ 95 % CI 0.60-0 .83 ] , p < 0.0001 ) .
RESULTS	The risk of developing breast cancer was similar between years 0-10 ( 226 [ 6.3 % ] in 3575 women in the placebo group vs 163 [ 4.6 % ] in 3579 women in the tamoxifen group ; hazard ratio [ HR ] 0.72 [ 95 % CI 0.59-0 .88 ] , p = 0.001 ) and after 10 years ( 124 [ 3.8 % ] in 3295 women vs 88 [ 2.6 % ] in 3343 , respectively ; HR 0.69 [ 0.53-0 .91 ] , p = 0.009 ) .
RESULTS	The greatest reduction in risk was seen in invasive oestrogen receptor-positive breast cancer ( HR 0.66 [ 95 % CI 0.54-0 .81 ] , p < 0.0001 ) and ductal carcinoma in situ ( 0.65 [ 0.43-1 .00 ] , p = 0.05 ) , but no effect was noted for invasive oestrogen receptor-negative breast cancer ( HR 1.05 [ 95 % CI 0.71-1 .57 ] , p = 0.8 ) .
CONCLUSIONS	These results show that tamoxifen offers a very long period of protection after treatment cessation , and thus substantially improves the benefit-to-harm ratio of the drug for breast cancer prevention .
BACKGROUND	Cancer Research UK ( UK ) and the National Health and Medical Research Council ( Australia ) .

###24388327
OBJECTIVE	To assess whether the combination of early inhaled nitric oxide ( iNO ) therapy and vitamin A supplementation lowers the incidence of bronchopulmonary dysplasia ( BPD ) in premature newborns with respiratory failure .
METHODS	A total of 793 mechanically ventilated infants ( birth weight 500-1250 g ) were randomized ( after stratification by birth weight ) to receive placebo or iNO ( 5 ppm ) for 21 days or until extubation ( 500-749 , 750-999 , or 1000-1250 g ) .
METHODS	A total of 398 newborns received iNO , and of these , 118 ( 30 % ) received vitamin A according to their enrollment center .
METHODS	We compared patients who received iNO + vitamin A with those who received iNO alone .
METHODS	The primary outcome was a composite of death or BPD at 36 weeks postconceptual age .
RESULTS	BPD was reduced in infants who received iNO + vitamin A for the 750-999 g birth weight group compared with iNO alone ( P = .01 ) .
RESULTS	This group also showed a reduction in the combined outcome of BPD + death compared with iNO alone ( P = .01 ) .
RESULTS	The use of vitamin A did not change the risk for BPD in the placebo group .
RESULTS	Overall , the use of vitamin A was low ( 229 of 793 patients , or 29 % ) .
RESULTS	Combined therapy improved Bayley Scales of Infant Development II Mental and Psychomotor Developmental Index scores at 1 year compared with infants treated solely with iNO for the 500-749 g birth weight group .
CONCLUSIONS	In this retrospective analysis of the nonrandomized use of vitamin A , combined iNO + vitamin A therapy in preterm infants with birth weight 750-999 g reduced the incidence of BPD and BPD + death and improved neurocognitive outcomes at 1 year in the 500-749 g birth weight group .

###24851570
BACKGROUND	Hypercholesterolemia is a strong risk factor in cardiovascular disease .
BACKGROUND	Oat ( Avena sativa L. ) beta-glucan , the soluble fiber in oat , has been known to reduce blood cholesterol levels considerably .
BACKGROUND	However , the effect of oat soluble fiber in the Thai population is unknown .
OBJECTIVE	To determine the effect of oat consumption on serum lipid profiles in Thai hypercholesterolemic adults .
METHODS	The present study was a randomized , crossover design .
METHODS	Twenty-four hypercholesterolemic adults , male and female aged 30-60 years , were randomly assigned into two groups of twelve each .
METHODS	Group 1 consumed 70 g ( 3 g beta-glucan ) of oatmeal daily through the first 4-week intervention , and then switched to 70 g rice porridge ( control product ) daily for the next 4-week intervention .
METHODS	Group 2 consumed rice porridge first and then oatmeal .
METHODS	Before and after each intervention period , lipid profiles including total cholesterol ( TC ) , triglycerides ( TG ) , high density lipoprotein cholesterol ( HDL-C ) , and low density lipoprotein cholesterol ( LDL-C ) of all subjects were measured .
RESULTS	Following daily oat consumption , total cholesterol and LDL-cholesterol levels were significantly lower than baseline levels and lower than the levels observed with rice consumption .
RESULTS	Oat consumption reduced total cholesterol by 5 % and LDL-cholesterol by 10 % from baseline levels .
RESULTS	In addition , mean and percent changes were significantly different from the levels after consuming rice porridge ( p < 0.05 ) .
CONCLUSIONS	Oatmeal reduced serum total cholesterol and LDL-cholesterol levels in hypercholesterolemic Thai adults .
CONCLUSIONS	Hence , oat consumption is a reasonable recommendation for Thai individuals with hyperlipidemia .

###24884807
BACKGROUND	Chest pain is the second most common reason patients visit emergency departments ( EDs ) and often results in very low-risk patients being admitted for prolonged observation and advanced cardiac testing .
BACKGROUND	Shared decision-making , including educating patients regarding their 45-day risk for acute coronary syndrome ( ACS ) and management options , might safely decrease healthcare utilization .
METHODS	This is a protocol for a multicenter practical patient-level randomized trial to compare an intervention group receiving a decision aid , Chest Pain Choice ( CPC ) , to a control group receiving usual care .
METHODS	Adults presenting to five geographically and ethnically diverse EDs who are being considered for admission for observation and advanced cardiac testing will be eligible for enrollment .
METHODS	We will measure the effect of CPC on ( 1 ) patient knowledge regarding their 45-day risk for ACS and the available management options ( primary outcome ) ; ( 2 ) patient engagement in the decision-making process ; ( 3 ) the degree of conflict patients experience related to feeling uninformed ( decisional conflict ) ; ( 4 ) patient and clinician satisfaction with the decision made ; ( 5 ) the rate of major adverse cardiac events at 30days ; ( 6 ) the proportion of patients admitted for advanced cardiac testing ; and ( 7 ) healthcare utilization .
METHODS	To assess these outcomes , we will administer patient and clinician surveys immediately after each clinical encounter , obtain video recordings of the patient-clinician discussion , administer a patient healthcare utilization diary , analyze hospital billing records , review the electronic medical record , and conduct telephone follow-up .
CONCLUSIONS	This multicenter trial will robustly assess the effectiveness of a decision aid on patient-centered outcomes , safety , and healthcare utilization in low-risk chest pain patients from a variety of geographically and ethnically diverse EDs .
BACKGROUND	NCT01969240 .

###25261674
OBJECTIVE	To evaluate the efficacy of a combined neurolytic block of the celiac and superior hypogastric plexuses for incapacitating upper abdominal cancer pain .
METHODS	Fifty-two patients with advanced upper abdominal malignancies and incapacitating pain were equally randomized to receive a combined neurolytic block of the celiac and superior hypogastric plexuses ( combined group ) or a neurolytic celiac plexus block alone ( NCPB group ) using a 90 % ethanol trans-intervertebral disk approach under CT guidance .
METHODS	Visual analogue scores ( VAS ) , morphine consumption , and quality of life ( QoL ) were assessed before the procedure and 24 hrs , 1 week , 1 month , and 3 months after the procedure .
METHODS	The complications and side effects were also recorded .
RESULTS	The amount of ethanol used was 30 5 ml in the combined group and 21 3 ml in the NCPB group .
RESULTS	VAS scores and morphine consumption decreased significantly pre - compared to post-procedure in both groups ( p < 0.05 ) .
RESULTS	QoL significantly improved 24 hrs , 1 week , and 1 month after the procedure compared with each group pre-procedure ( p < 0.05 ) , but not after 3 months ( p > 0.05 ) .
RESULTS	The combined group had significantly lower VAS and morphine consumption than the NCPB group ( p < 0.05 ) .
RESULTS	QoL scores were significantly higher in the combined group 24 hrs , 1 week , and 1 month post-procedure than the NCPB group ( p < 0.05 ) , but not after 3 months ( p > 0.05 ) .
CONCLUSIONS	A combined neurolytic block of the celiac and superior hypogastric plexuses is more effective than neurolytic celiac plexus block alone in pain relief for patients with advanced upper abdominal cancer .

###24325111
OBJECTIVE	To assess the effectiveness of task-oriented approach in treating patients with spastic dysarthria .
METHODS	A randomized control trial was undertaken in 44 inpatients diagnosed with spastic dysarthria at the Department of Rehabilitation Medicine in West China Hospital .
METHODS	All of the participants received basic medical therapy , occupational therapy , physical therapy , and an articulation approach for speech therapy by a professional speech therapist over a one month period .
METHODS	A task-oriented approach was added to the speech therapy regime of the test group of participants by another professional speech therapist over the same period of time .
METHODS	The outcomes of speech therapy were measured by the Frenchay dysarthria assessment ( FDA ) .
RESULTS	Significant improvements were found in the test group in relation to 15 FDA items , such as dribbling , lips spread , and palate maintenance ( P < 0.05 ) .
RESULTS	The performance of the participants in the test group on the rest of FDA items also demonstrated an improvement trend compared with that of the controls ( P > 0.05 ) except for the three items in relation to cough , lips at rest and jaw in speech .
CONCLUSIONS	Task-oriented approach for speech therapy is effective in treating patients with spastic dysarthria .
CONCLUSIONS	A task-oriented approach in combination with an articulation approach can produce better patient outcomes compared with the articulation approach alone .
CONCLUSIONS	Further studies are warranted .

###25936817
OBJECTIVE	This report is the second analysis of a prospective randomized trial to investigate the impact of ( 18 ) F-fluorodeoxyglucose positron emission tomography ( FDG-PET ) on cervical cancer patients with enlarged pelvic lymph nodes identified by magnetic resonance imaging .
METHODS	Patients with newly diagnosed cervical cancer with enlarged pelvic lymph nodes but free of enlarged para-aortic lymph nodes ( PALN ) were eligible .
METHODS	Patients were randomized to receive either pretreatment FDG-PET ( PET arm ) or not ( control arm ) .
METHODS	The whole pelvis was the standard irradiation field for all patients except those with FDG-avid extrapelvic findings .
RESULTS	In all , 129 patients were enrolled .
RESULTS	Pretreatment PET detected extrapelvic metastases in 7 patients .
RESULTS	No new patient experienced treatment failure during the additional 4-year follow-up period .
RESULTS	There were no significant differences between the PET arm and the control arm regarding overall survival , disease-free survival , and freedom from extrapelvic metastasis .
RESULTS	In the control arm , 8 of 10 patients with PALN relapse had limited extrapelvic nodal failures ; their 5-year disease-specific survival was 34.3 % .
RESULTS	By contrast , only 1 of 5 patients with PALN relapse in the PET arm experienced such limited failures ; their 5-year survival rate was 0 % .
CONCLUSIONS	Although the pretreatment detection of PALN did not translate into survival benefit , it indeed decreased the need for extended-field concurrent chemoradiation therapy .

###24290414
OBJECTIVE	To demonstrate the bioequivalence between the test and reference formulations of losartan/hydrochlorothiazide 50 + 12.5 mg tablet and evaluate the effect of ethnicity on pharmacokinetics properties of losartan , losartan carboxylic acid and hydrochlorothiazide on healthy Asian Indian and Japanese volunteers .
METHODS	Randomized , open-label , crossover , bioavailability studies were conducted separately in healthy Asian Indian and Japanese volunteers .
METHODS	One tablet either of test or of reference product was administered after 10 hours of overnight fasting .
METHODS	After dosing , serial blood samples were collected for a period of 48 hours for both the studies .
METHODS	Plasma samples were analyzed for losartan , losartan carboxylic acid and hydrochlorothiazide by a validated liquid chromatographic and mass spectrometric method ( LC-MS/MS ) .
METHODS	The pharmacokinetic parameters AUC0-t , AUC0 - , Cmax , tmax , and other pharmacokinetics parameters were determined from plasma concentration-time profiles for both test and reference formulations of losartan/hydrochlorothiazide 50 + 12.5 mg tablets .
METHODS	Statistical evaluations were done to evaluate bioequivalence between generic test formulation ( EPR0001 ) and Japanese reference product ( Preminent ) .
RESULTS	Losartan , losartan carboxylic acid and hydrochlorothiazide were well tolerated by subjects in all periods of each study under fasted conditions .
RESULTS	No serious adverse events were observed .
RESULTS	The ratios of least square means for AUC0-t and Cmax and the affiliated 90 % confidence intervals were within acceptance range recommended by PMDA .
RESULTS	Marginal differences were observed in pharmacokinetic values of Asian Indian and Japanese volunteers .
CONCLUSIONS	The results of these bioavailability studies indicate that the test formulation of losartan/hydrochlorothiazide 50 + 12.5 mg ( EPR0001 ) tablets is bioequivalent to marketed Preminent reference formulation in Asian Indian and Japanese volunteers , when administered under fasting conditions .
CONCLUSIONS	Both test and reference formulations were well tolerated as a single oral dose when administered to healthy adult subjects under fasted conditions .
CONCLUSIONS	Although Asian Indian and Japanese volunteers are ethnically different , results of these studies indicate that pharmacokinetic parameters of Asian Indian and Japanese volunteers are comparable to each other in terms of bioavailability of losartan , losartan carboxylic acid and hydrochlorothiazide .
CONCLUSIONS	Similar least square means ratios were obtained in Asian Indian and Japanese volunteers demonstrating that a bioequivalence study conducted on Japanese volunteers seems to be substituted by Asian Indian volunteers ' studies .

###25115438
BACKGROUND	Suboptimal vitamin D status is highly prevalent in Northern communities , particularly in those patients with chronic diseases such as diabetes and chronic renal disease .
BACKGROUND	Emerging literature suggests that adherence to daily vitamin D supplementation may be an important factor influencing vitamin D status and overall bone health , but compliance with therapies for bone health is a major challenge .
BACKGROUND	It is unknown what level of vitamin D supplementation will ameliorate or improve suboptimal vitamin D status in patients with diabetic nephropathy or contribute to improved bone health , particularly for those living in northern climates .
METHODS	The study purpose was to examine two different strategies of vitamin D3 supplementation ; daily dosing of 2000IU per day verses monthly dosing of 40,000 IU per month on markers of vitamin D status , bone health and to examine whether adherence , quality of life and patient satisfaction with the supplementation strategy differs between the two vitamin D strategies in adults diagnosed with diabetic nephropathy .
CONCLUSIONS	The need for RCTs assessing higher doses of vitamin D3 supplementation at varying frequencies of administration and its impact on bone health in adults with diabetes and chronic kidney disease are needed .
BACKGROUND	ClinicalTrials.gov NCT01476501 .

###25194668
OBJECTIVE	Deodorant use during radiation therapy for breast cancer has been controversial as there are concerns deodorant use may exacerbate axillary skin toxicity .
OBJECTIVE	The present study prospectively determined the use of both aluminum-containing and non aluminum containing deodorants on axillary skin toxicity during conventionally fractionated postoperative radiation therapy for breast cancer .
METHODS	This 3-arm randomized controlled study was conducted at a single center , tertiary cancer hospital between March 2011 and April 2013 .
METHODS	Participants were randomized to 1 of 2 experimental groups ( aluminum-containing deodorant and soap or non-aluminum containing deodorant and soap ) or a control group ( soap ) .
METHODS	A total of 333 participants were randomized .
METHODS	Generalized estimating equations were used to estimate and compare the odds of experiencing high levels of sweating and skin toxicity in each of the deodorant groups to the odds in the control group .
METHODS	The study evaluated a range of endpoints including objective measurements of axilla sweating , skin toxicity , pain , itch and burning .
METHODS	Quality of life was assessed with a validated questionnaire .
RESULTS	Radiation characteristics were similar across all groups .
RESULTS	Patients in the deodorant groups did not report significantly different ratings for axillary pain , itch , or burning compared with the control group .
RESULTS	Patients in the aluminum-containing deodorant group experienced significantly less sweating than the control ; the odds of their sweating being barely tolerable and frequently or always interfering with their daily activities was decreased by 85 % ( odds ratio , 0.15 ; 95 % confidence interval , 0.03-0 .91 ) .
CONCLUSIONS	We found no evidence that the use of either aluminum-containing or non-aluminum containing deodorant adversely effects axillary skin reaction during conventionally fractionated radiation therapy for breast cancer .
CONCLUSIONS	Our analysis also suggests patients in the aluminum-containing deodorant arm had significantly less sweating without increased symptoms of axillary radiation skin toxicity .
CONCLUSIONS	These results add to the evidence that the prescription of deodorants during radiation therapy for breast cancer is now questionable .

###24449597
BACKGROUND	Ticagrelor outperforms clopidogrel in preventing cardiovascular events in acute coronary syndrome .
BACKGROUND	Despite the inclusion of a loading dose in the Platelet Inhibition and Patient Outcomes ( PLATO ) trial for all patients randomized to ticagrelor , it may not be necessary in patients receiving ongoing clopidogrel therapy .
BACKGROUND	The aim of the present study was to assess whether a ticagrelor loading dose is associated with a further platelet inhibition during the switch from clopidogrel to ticagrelor in patients with acute coronary syndrome receiving ongoing antiplatelet treatment .
RESULTS	Fifty patients with acute coronary syndrome receiving aspirin and clopidogrel treatment were randomly assigned to a starting dose of ticagrelor ( group 1 , 90 mg ; group 2 , 180 mg ) .
RESULTS	Platelet aggregation was measured using multiple electrode aggregometry and standard light transmission aggregometry just before the switch and at 2 , 6 , 24 , and 72 hours .
RESULTS	No relevant difference in platelet aggregation was observed between the 2 study arms at baseline ( P = 0.256 ) .
RESULTS	Residual platelet aggregation was significantly reduced in both arms 2 hours after the first administration of ticagrelor ( P < 0.001 for both ) , with no difference in aggregation between groups ( multiple electrode aggregometry , 17.67.2 versus 18.16 U ; P = 0.281 ) .
RESULTS	Similar results were observed with LTA .
CONCLUSIONS	Switching from clopidogrel to ticagrelor without a reloading dose is feasible , and it does not hinder platelet aggregation inhibition in patients with acute coronary syndrome .
CONCLUSIONS	Further prospective studies are needed to assess the clinical relevance of our findings .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01795820 .

###25198275
OBJECTIVE	To evaluate the association of duration of magnesium sulfate infusion with stillbirth or death , cerebral palsy , and select adverse maternal and neonatal outcomes .
METHODS	This is a secondary cohort analysis of women randomized to receive magnesium sulfate within a previously reported Maternal-Fetal Medicine Units Network prospective clinical trial .
METHODS	The association of antenatal infusion of magnesium sulfate for less than 12 hours , 12-18 hours , and greater than 18 hours on maternal and perinatal outcomes was compared .
METHODS	The primary outcome was cerebral palsy of any severity or death .
METHODS	Secondary outcomes included cerebral palsy , death , and select maternal and neonatal outcomes .
METHODS	Stratified and logistic regression analyses were used .
METHODS	The models were adjusted for race , gestational age at birth , time since last magnesium sulfate , any magnesium sulfate at delivery , and eligibility criteria as appropriate .
RESULTS	Of 933 women available for analysis , 356 , 341 , and 236 received antenatal magnesium sulfate infusion for a total of less than 12 hours , 12-18 hours , or greater than 18 hours , respectively .
RESULTS	Any cerebral palsy or death occurred in 39 women ( 11.7 % ) who received magnesium sulfate less than 12 hours , 34 women ( 10.3 % ) who received 12-18 hours of magnesium sulfate , and 20 women ( 8.8 % ) who received greater than 18 hours of magnesium sulfate .
RESULTS	There was no difference in death or cerebral palsy among groups ( less than 12 hours as reference ; adjusted odds ratio [ OR ] 1.03 , 95 % confidence interval [ CI ] 0.60-1 .77 for 12-18 hours ; adjusted OR 1.08 , 95 % CI 0.57-2 .03 for greater than 18 hours ) .
RESULTS	Select maternal adverse drug affects and neonatal morbidities were also similar across groups .
CONCLUSIONS	The duration of antenatal magnesium sulfate infusion is not associated with risk of death or cerebral palsy .
CONCLUSIONS	The optimal treatment duration needed for maximal neuroprotection remains unknown .
METHODS	: II .

###24899558
BACKGROUND	Clear directions and explanations from nurses related to health behaviors and discharge procedures have been shown to effectively reduce the risk of patient readmission .
BACKGROUND	Nurses thus need to develop good communication skills in order to ensure that their communications help patients become better-informed and less anxious about discharge procedures .
OBJECTIVE	This research evaluates the communication skills of nurses following two different education interventions .
METHODS	Experimental design principles for education interventions were followed in this research .
METHODS	Medical nurses certified at the N to N2 level in a municipal hospital in Taipei City were enrolled as participants ( N = 78 ) and divided into an experimental group and control group using stratified purposive randomization .
METHODS	The experimental group received clinical scenario-based simulation education for communication .
METHODS	The control group received standard class-based education for communication .
METHODS	Both groups received a pre-test evaluation and an OSCE post-test evaluation .
METHODS	Results were analyzed using SPSS 17.0 software .
RESULTS	Independent t-test results revealed significant increases in communication skills ( t = 3.406 , p < .05 ) in both groups , with the increase in the experimental group ( M = 5.00 , SD = 0.82 ) significantly greater than the increase in the control group ( M = 4.11 , SD = 1.41 ) .
RESULTS	However , the mean scores from the post-test standardized patient survey found no significant differences between the two groups in terms of communication skills .
CONCLUSIONS	The results indicate that the clinical scenario-based simulation education intervention is more effective than traditional class-based education in enhancing the communication skills of nurses .

###24913683
OBJECTIVE	Abdominal aortic aneurysm patients tend to be informed inconsistently and incompletely about their disorder and the treatment options open to them .
OBJECTIVE	The objective of this trial was to evaluate whether these patients are better informed and experience less decisional conflict regarding their treatment options after viewing a decision aid .
METHODS	A six-centre , randomised clinical trial comparing a decision aid plus regular information versus regular information from the surgeon .
METHODS	Included patients had recently been diagnosed with an asymptomatic abdominal aortic aneurysm at least 4 cm in diameter .
METHODS	The decision aid consisted of a one-time viewing of an interactive CD-ROM elaborating on elective surgery versus watchful waiting .
METHODS	Generally , the decision aid advised patients with aneurysms less than 5.5 cm to agree to watchful waiting , for larger aneurysms the decision aid provided insight into the balance of benefit and harm of surgical and conservative approaches , taking into account age , co-morbidity and size of the aneurysm .
METHODS	The primary outcome was patient decisional conflict measured at 1 month follow-up ( Decisional Conflict Scale ) .
METHODS	Secondary outcomes were patient knowledge , anxiety and satisfaction .
RESULTS	In 178 aneurysm patients , decisional conflict scores did not differ significantly between the decision aid and the regular information groups ( 22 vs. 24 on the 0-100 Decisional Conflict Scale ; p = .33 ) .
RESULTS	Patients in the decision aid group had significantly better knowledge ( 10.0 vs. 9.4 out of 13 points ; p = .04 ) , whereas anxiety levels ( 4.4 and 5.0 on a 0-21 scale ; p = .73 ) and satisfaction scores ( 74 and 73 on a 0-100 scale ; p = .81 ) were similar in both groups .
CONCLUSIONS	In addition to regular patient-surgeon communication , a decision aid helps to share treatment decisions with abdominal aortic aneurysm patients by increasing their knowledge about the disorder and available treatment options without raising anxiety levels ; however , it does not reduce decisional conflict , nor does it improve satisfaction .

###24439313
BACKGROUND	Patients with isolated locoregional recurrences ( ILRR ) of breast cancer have a high risk of distant metastasis and death from breast cancer .
BACKGROUND	We aimed to establish whether adjuvant chemotherapy improves the outcome of such patients .
METHODS	The CALOR trial was a pragmatic , open-label , randomised trial that accrued patients with histologically proven and completely excised ILRR after unilateral breast cancer who had undergone a mastectomy or lumpectomy with clear surgical margins .
METHODS	Eligible patients were enrolled from hospitals worldwide and were centrally randomised ( 1:1 ) to chemotherapy ( type selected by the investigator ; multidrug for at least four courses recommended ) or no chemotherapy , using permuted blocks , and stratified by previous chemotherapy , oestrogen-receptor and progesterone-receptor status , and location of ILRR .
METHODS	Patients with oestrogen-receptor-positive ILRR received adjuvant endocrine therapy , radiation therapy was mandated for patients with microscopically involved surgical margins , and anti-HER2 therapy was optional .
METHODS	The primary endpoint was disease-free survival .
METHODS	All analyses were by intention to treat .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00074152 .
RESULTS	From Aug 22 , 2003 , to Jan 31 , 2010 , 85 patients were randomly assigned to receive chemotherapy and 77 were assigned to no chemotherapy .
RESULTS	At a median follow-up of 49 years ( IQR 36-6 0 ) , 24 ( 28 % ) patients had disease-free survival events in the chemotherapy group compared with 34 ( 44 % ) in the no chemotherapy group .
RESULTS	5-year disease-free survival was 69 % ( 95 % CI 56-79 ) with chemotherapy versus 57 % ( 44-67 ) without chemotherapy ( hazard ratio 059 [ 95 % CI 035-099 ] ; p = 0046 ) .
RESULTS	Adjuvant chemotherapy was significantly more effective for women with oestrogen-receptor-negative ILRR ( pinteraction = 0046 ) , but analyses of disease-free survival according to the oestrogen-receptor status of the primary tumour were not statistically significant ( pinteraction = 043 ) .
RESULTS	Of the 81 patients who received chemotherapy , 12 ( 15 % ) had serious adverse events .
RESULTS	The most common adverse events were neutropenia , febrile neutropenia , and intestinal infection .
CONCLUSIONS	Adjuvant chemotherapy should be recommended for patients with completely resected ILRR of breast cancer , especially if the recurrence is oestrogen-receptor negative .
BACKGROUND	US Department of Health and Human Services , Swiss Group for Clinical Cancer Research ( SAKK ) , Frontier Science and Technology Research Foundation , Australian and New Zealand Breast Cancer Trials Group , Swedish Cancer Society , Oncosuisse , Cancer Association of South Africa , Foundation for Clinical Research of Eastern Switzerland ( OSKK ) , Grupo Espaol de Investigacin en Cncer de Mama ( GEICAM ) , and the Dutch Breast Cancer Trialists ' Group ( BOOG ) .

###24281279
OBJECTIVE	This meta-analysis compared the earliest clinical effects of intra-articular bupivacaine and morphine for pain management following arthroscopic knee surgery .
METHODS	A comprehensive literature search was conducted using MEDLINE ( 1966 to 2013 ) , the Cochrane Central Register of Controlled Trials ( CENTRAL ) , Embase , and Google Scholar databases for identification of randomized-controlled trials that compared IA bupivacaine and morphine for postoperative pain .
METHODS	The relative risk , weighted mean difference ( WMD ) , and their corresponding 95 % confidence intervals ( CI ) were calculated using RevMan statistical software .
RESULTS	Bupivacaine and morphine group had similar acute postoperative pain scores ( WMD : 0.07 ; 95 % CI , -0.18 to 0.32 ; P = 0.60 ) ; number of patients requiring supplementary analgesia ( relative risk : 0.74 ; 95 % CI , 0.42 to 1.31 ; P = 0.30 ) for the trials in this meta-analysis ( n = 13 ) ; and side effects ( relative risk : 0.63 ; 95 % CI , 0.39 to 1.02 , P = 0.06 ) .
RESULTS	Even though , the time to first analgesic request resulted in a significant difference ( WMD : 66.59 ; 95 % CI , 11.75 to 122.14 , P = 0.02 ) , this result was not supported by the sensitivity analysis .
CONCLUSIONS	On the basis of the currently available literature , this study failed to demonstrate a significant difference between single-dose intra-articular bupivacaine and morphine at the end of the arthroscopic knee surgery in terms of pain relief , need for supplementary analgesics , times interval before the first request for additional analgesic , and short-term side effects .
METHODS	Level II-meta-analysis of Level I and II studies .

###25437483
OBJECTIVE	To evaluate the outcome of accelerated and conventional corneal cross-linking ( CXL ) procedures regarding their effect on morphological and optical properties of the cornea .
METHODS	One hundred fifty-three eyes of 153 patients were evaluated before and during a 15-month follow-up period after CXL ( 76 eyes in the conventional group and 77 eyes in the accelerated group ) .
METHODS	Measured variables include corrected distance visual acuity ( CDVA ) , uncorrected distance visual acuity ( UDVA ) , refraction , maximum keratometry , endothelial cell density , anterior and posterior stromal keratocyte density , and subbasal nerve density .
METHODS	All variables were compared between the two study groups .
RESULTS	Cylindrical and spherical components of refraction improved significantly during 15 months of follow-up .
RESULTS	No difference was observed between the two study groups .
RESULTS	UDVA and CDVA improved in the same manner , with no intergroup differences .
RESULTS	Endothelial cell density did not change significantly during the follow-up period in either group .
RESULTS	K-max increased slightly in the first month of the follow-up , but started to decrease at postoperative visits without any significant difference in the two groups .
RESULTS	Anterior stromal keratocyte density and subbasal nerve density decreased significantly in both groups 1 month postoperatively .
RESULTS	Both variables had a more significant decrease in the conventional group at all visits before the 1-year visit .
RESULTS	At the final 15-month visit , there were no significant differences in any value between the two groups .
CONCLUSIONS	Accelerated and conventional CXL seem to have a comparable and acceptable effect on keratoconus in the short-term follow-up period .

###25589220
OBJECTIVE	Axitinib is a potent and selective inhibitor of vascular endothelial growth factor receptors 1-3 , approved for second-line treatment of advanced renal cell carcinoma ( RCC ) .
OBJECTIVE	Preclinical studies did not indicate potential for axitinib-induced delayed cardiac repolarization .
METHODS	The effect of axitinib on corrected QT ( QTc ) prolongation was evaluated with one-stage concentration-QTc response modeling using data from a definitive randomized crossover QT phase I study in healthy volunteers administered one single 5-mg axitinib dose alone or in the presence of steady-state ketoconazole ( 400mg once daily ) .
RESULTS	Axitinib and ketoconazole had opposite effects on heart rate : Axitinib lowered it , ketoconazole raised it .
RESULTS	The final analysis showed a flat relationship between QTc and axitinib concentration ( slope -0.0314 msmL/ng ) for axitinib alone .
RESULTS	Mean highest placebo-matched change from baseline in QTc was -3.0 [ 90 % confidence interval ( CI ) -5.4 , -0.6 ] ms. At supratherapeutic axitinib exposures achieved with potent cytochrome P450 3A4/5 inhibition by ketoconazole , the model predicted mean QTc change of 6.5 ( 90 % CI 4.4-8 .5 ) ms. The slope population mean estimate was -0.331 ( 95 % CI -0.860 , 0.198 ) msmL/g for ketoconazole alone and 0.0725 ( 0.0445-0 .1005 ) msmL/ng for axitinib in the presence of ketoconazole .
RESULTS	The results were then compared with those obtained based on more widely used Fridericia 's , Bazett 's , and study-specific correction methods .
CONCLUSIONS	Since axitinib plasma concentrations observed in this study exceeded the range of concentrations observed in patients with RCC at the highest approved clinical dose ( 10mg twice daily ) , axitinib was not associated with clinically significant QTc prolongation in target populations .

###25605660
BACKGROUND	Adolescent metabolic syndrome ( MetS ) predicts type 2 diabetes mellitus and subclinical atherosclerosis in adulthood .
BACKGROUND	Our aim was to establish the relationship between an infancy-onset dietary intervention and risk of having MetS between 15 and 20 years of age .
RESULTS	The Special Turku Coronary Risk Factor Intervention Project for Children ( STRIP ) study is a longitudinal , randomized atherosclerosis prevention trial in which repeated dietary counseling aiming at reducing intake of saturated fat took place from infancy to early adulthood .
RESULTS	Participants who had complete data on the MetS components ( waist circumference , blood pressure , triglycerides , glucose , high-density lipoprotein cholesterol ) at 15 ( n = 512 ) , 16 ( n = 485 ) , 17 ( n = 475 ) , 18 ( n = 459 ) , 19 ( n = 439 ) , and 20 ( n = 407 ) years of age were included in the study .
RESULTS	Modified International Diabetes Foundation criteria with 80th/20th percentile cutoff points for the components were primarily applied in statistical analyses , and the results were replicated with the use of other pediatric MetS definitions .
RESULTS	Between the ages of 15 and 20 years , the prevalence of MetS varied between 6.0 % and 7.5 % in participants in the intervention group and between 10 % and 14 % in the control group .
RESULTS	The long-term relative risk of MetS was significantly lower in the intervention group ( relative risk , 0.59 ; 95 % confidence interval , 0.40-0 .88 ; P = 0.009 ) .
RESULTS	Of the individual MetS components , the intervention decreased risk of high blood pressure in both sexes ( relative risk , 0.83 ; 95 % confidence interval , 0.70-0 .99 ) and high triglycerides in male subjects ( relative risk , 0.71 ; 95 % confidence interval , 0.52-0 .98 ) .
RESULTS	A statistically nonsignificant reduction was seen in the risk of high waist circumference in the intervention individuals ( relative risk , 0.78 ; 95 % confidence interval , 0.59-1 .03 ) .
CONCLUSIONS	Repeated infancy-onset dietary intervention is effective in the prevention of MetS in adolescence .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00223600 .

###24561732
OBJECTIVE	To evaluate the clinical efficacy of the coronary sinus ( CS ) Reducer in attenuating angina severity in patients suffering from severe refractory angina .
RESULTS	Patients with refractory angina , objective evidence of myocardial ischaemia and no option for revascularisation were treated with CS Reducer implantation at two medical centres .
RESULTS	Six-month follow-up evaluation consisted of clinical assessment of angina severity .
RESULTS	Objective assessment of ischaemia at six-month follow-up was performed in one of the two centres .
RESULTS	Successful CS Reducer implantation was achieved in 21 of 23 eligible patients , at both centres .
RESULTS	No device-related adverse effects were observed during the procedure or the follow-up period .
RESULTS	Canadian Cardiovascular Society ( CCS ) score diminished from a mean of 3.3 at baseline to 2.0 at six months ( n = 20 , p < 0.01 ) , exercise duration was prolonged from 3:16 to 5:16 min ( min : sec ; n = 8 , p = 0.05 ) .
RESULTS	Thallium SPECT summed stress score and summed difference score were both reduced ( n = 9 , 21.510 vs. 13.29 , p = 0.01 , and 11.16 vs. 4.74 , p = 0.007 , respectively ) .
RESULTS	Wall motion score index at peak dobutamine infusion was also significantly improved ( n = 8 , 1.90.4 vs. 1.40.4 , p = 0.046 ) .
CONCLUSIONS	CS Reducer implantation was safe and resulted in significant improvement of angina class .
CONCLUSIONS	The results of the ongoing randomised sham-control trial will address the concern regarding the possible placebo effect , and hopefully further support our encouraging observations .

###25883095
OBJECTIVE	To evaluate whether an epidural steroid injection or gabapentin is a better treatment for lumbosacral radiculopathy .
METHODS	A multicenter randomized study conducted between 2011 and 2014 .
METHODS	Computer generated randomization was stratified by site .
METHODS	Patients and evaluating physicians were blinded to treatment outcomes .
METHODS	Eight military , Veterans Administration , and civilian hospitals .
METHODS	145 people with lumbosacral radicular pain secondary to herniated disc or spinal stenosis for less than four years in duration and in whom leg pain is as severe or more severe than back pain .
METHODS	Participants received either epidural steroid injection plus placebo pills or sham injection plus gabapentin .
METHODS	Average leg pain one and three months after the injection on a 0-10 numerical rating scale .
METHODS	A positive outcome was defined as a 2 point decrease in leg pain coupled with a positive global perceived effect .
METHODS	All patients had one month follow-up visits ; patients whose condition improved remained blinded for their three month visit .
RESULTS	There were no significant differences for the primary outcome measure at one month ( mean pain score 3.3 ( SD 2.6 ) and mean change from baseline -2.2 ( SD 2.4 ) in epidural steroid injection group versus 3.7 ( SD 2.6 ) and -1.7 ( SD 2.6 ) in gabapentin group ; adjusted difference 0.4 , 95 % confidence interval -0.3 to 1.2 ; P = 0.25 ) and three months ( mean pain score 3.4 ( SD 2.7 ) and mean change from baseline -2.0 ( SD 2.6 ) versus 3.7 ( SD 2.8 ) and -1.6 ( SD 2.7 ) , respectively ; adjusted difference 0.3 , -0.5 to 1.2 ; P = 0.43 ) .
RESULTS	Among secondary outcomes , one month after treatment those who received epidural steroid injection had greater reductions in worst leg pain ( -3.0 , SD 2.8 ) than those treated with gabapentin ( -2.0 , SD 2.9 ; P = 0.04 ) and were more likely to experience a positive successful outcome ( 66 % v 46 % ; number needed to treat = 5.0 , 95 % confidence interval 2.8 to 27.0 ; P = 0.02 ) .
RESULTS	At three months , there were no significant differences between treatments .
CONCLUSIONS	Although epidural steroid injection might provide greater benefit than gabapentin for some outcome measures , the differences are modest and are transient for most people.Trial registration ClinicalTrials.gov Identifier : NCT01495923 .

###24932945
BACKGROUND	This study sought to examine the utility of hair testing as a research measure of drug use among individuals with moderate-risk drug use based on the internationally validated Alcohol , Smoking , and Substance Involvement Screening Test ( ASSIST ) .
METHODS	This study is a secondary analysis using baseline data from a randomized trial of brief intervention for drug misuse , in which 360 adults with moderate-risk drug use were recruited from two community clinics in New Mexico , USA .
METHODS	The current study compared self-reported drug use on the ASSIST with laboratory analysis of hair samples using a standard commercially available 5-panel test with assay screening and gas chromatography/mass spectrometry ( GC/MS ) confirmation .
METHODS	Both self-report and hair testing covered a 3-month period .
RESULTS	Overall concordance between hair testing and self-report was 57.5 % ( marijuana ) , 86.5 % ( cocaine ) , 85.8 % ( amphetamines ) , and 74.3 % ( opioids ) .
RESULTS	Specificity of hair testing at standard laboratory cut-offs exceeded 90 % for all drugs , but sensitivity of hair testing relative to self-report was low , identifying only 52.3 % ( 127/243 ) of self-disclosed marijuana users , 65.2 % ( 30/46 ) of cocaine users , 24.2 % ( 8/33 ) of amphetamine users , and 2.9 % ( 2/68 ) of opioid users .
RESULTS	Among participants who disclosed using marijuana or cocaine in the past 3 months , participants with a negative hair test tended to report lower-frequency use of those drugs ( p < .001 for marijuana and cocaine ) .
CONCLUSIONS	Hair testing can be useful in studies with moderate-risk drug users , but the potential for under-identification of low-frequency use suggests that researchers should consider employing low detection cut-offs and using hair testing in conjunction with self-report .

###24810309
OBJECTIVE	Fingertip injuries , which are the most common hand injury , represent management challenges for hand surgeons .
OBJECTIVE	Full thickness skin grafts are routinely used to cover the fingertip site , but has significant donor site morbidity .
OBJECTIVE	As amniotic membranes ( AM ) are used as a dressing substitute in burns , we decided to evaluate the efficacy of AM as a biologic wound dressing material for coverage of these injuries .
METHODS	In this clinical study , 30 patients with full-thickness zone 1 fingertip skin loss were included .
METHODS	The patients were divided into 2 groups using the block randomisation method .
METHODS	In the first group , a skin graft was used for coverage and in the second group , AM was used .
METHODS	All patients were operated on by the same hand surgeon between February 2012 to October 2012 .
METHODS	The minimum follow-up period was 6 months .
METHODS	Two point discrimination ( T.P.D ) , light touch , healing time , days lost from work and infection rate were evaluated and recorded .
RESULTS	This study recruited 30 patients with full-thickness zone 1 fingertip skin loss ( age range 13-47 years ) .
RESULTS	Fingertips in both groups were assessed .
RESULTS	T.P.D , light touch and days lost from work were significantly lower in the AM group than in the skin graft group .
RESULTS	Healing time was lower in the skin graft group .
RESULTS	In the both groups , no infection was detected .
RESULTS	Patients of both groups were satisfied of their treatment and healing progress .
CONCLUSIONS	Our results showed the effectiveness and safety of AM for the treatment of fingertip amputation , which can produce better sensation and functional outcomes than skin graft transplantations .

###24722044
OBJECTIVE	To identify the effects of a brief educational intervention on stroke patients ' recall and recognition of risk factors and performance of and stage of change for stroke risk-related behaviors .
METHODS	Sixty-six patients with stroke participated in a multisite randomized controlled trial .
METHODS	The intervention group ( n = 35 ) received a brief education intervention ( tailored written stroke information , verbal reinforcement of information for 3 months after discharge , and provision of a telephone number ) .
METHODS	The control group ( n = 31 ) received usual care .
METHODS	Unprompted recall ( personal and general ) , prompted recognition of risk factors ( 0-13 ) , and performance of ( 0-10 ) and stage of change for up to 7 stroke risk-related behaviors were assessed before and 3 months after discharge .
RESULTS	No significant between-group differences were found .
RESULTS	For all participants over time , there were significant improvements for personal ( mean difference [ MD ] , 0.3 ; 95 % CI , 0.004-0 .69 ; P = .05 ) and general ( MD , 0.6 ; 95 % CI , 0.09-1 .16 ; P = .02 ) risk factor recall ; performance of stroke risk-related behaviors ( MD , 0.8 ; 95 % CI , 0.28-1 .26 ; P < .01 ) ; and progression from a nonaction to an action stage of change for 4 of 7 behaviors over time .
RESULTS	There was a significant decline in total risk factor recognition scores ( MD , -0.8 ; 95 % CI , 0.39-1 .13 ; P < .01 ) .
CONCLUSIONS	Stroke patients ' unprompted recall of risk factors and performance of risk-related behaviors improved over time ; readiness to change risk-related behaviors progressed for some behaviors .
CONCLUSIONS	A brief educational intervention did not improve risk factor awareness or behavior change more than usual care .

###24802654
BACKGROUND	Epidermal growth factor receptor overexpression is associated with poor outcomes in urothelial carcinoma ( UC ) .
BACKGROUND	Cetuximab ( CTX ) exhibited an antitumor effect in in vivo UC models .
BACKGROUND	The efficacy of gemcitabine/cisplatin ( GC ) with or without CTX in patients with advanced UC was evaluated .
METHODS	Patients with advanced UC , measurable disease , and adequate organ function were randomized 1:2 to cisplatin ( 70 mg/m ( 2 ) ) on day 1 plus gemcitabine ( 1000 mg/m ( 2 ) ) on days 1 , 8 , and 15 ( arm A ) or GC plus CTX ( 500 mg/m ( 2 ) ) on days 1 and 15 ( arm B ) .
METHODS	The primary endpoint was the overall response rate .
METHODS	The secondary endpoints were the response duration , safety , progression-free survival , overall survival , determination of whether or not CTX sensitized nonresponders to GC , and exploratory biomarker analysis .
METHODS	The accrual targets were 27 and 54 patients for the 2 arms , respectively .
METHODS	The overall response rate was reported by arm with binomial confidence intervals ( CIs ) .
METHODS	Kaplan-Meier methods were used for time-to-event endpoints .
RESULTS	Eighty-eight eligible patients were randomized ; 87 were toxicity-evaluable , and 85 were response-evaluable .
RESULTS	The overall response rates were 57.1 % for arm A ( 95 % CI = 37 % -76 % ) and 61.4 % for arm B ( 95 % CI = 48 % -74 % ) .
RESULTS	The median progression-free survival times were 8.5 months for arm A ( 95 % CI = 5.7-10 .4 months ) and 7.6 months for arm B ( 95 % CI = 6.1-8 .7 months ) .
RESULTS	The median overall survival times were 17.4 months for arm A ( 95 % CI = 12.8 months to unreached ) and 14.3 months for arm B ( 95 % CI = 11.6-22 .2 months ) .
RESULTS	The most common grade 3/grade 4 adverse events in both arms were myelosuppression and nausea .
RESULTS	Thromboembolism , acneiform rash , fatigue , pain , hypersensitivity reactions , elevated transaminases , hyponatremia , and hypomagnesemia were more common in arm B ; 3 grade 5 adverse events occurred in arm B.
RESULTS	The presence of primary disease significantly correlated with thromboembolism .
RESULTS	An increased soluble E-cadherin level after cycle 2 correlated with a higher risk of death .
CONCLUSIONS	GC plus CTX was feasible but was associated with more adverse events and no improvements in outcomes .

###24521107
BACKGROUND	Infections with soil-transmitted helminths ( Ascaris lumbricoides , hookworm , and Trichuris trichiura ) are widespread and often occur concomitantly .
BACKGROUND	These parasitic-worm infections are typically treated with albendazole or mebendazole , but both drugs show low efficacy against T. trichiura .
BACKGROUND	Albendazole is the drug of choice against hookworm .
METHODS	In this double-blind trial conducted on Pemba Island , Tanzania , we randomly assigned children , 6 to 14 years of age , to receive one of four treatments : oxantel pamoate at a dose of 20 mg per kilogram of body weight , plus 400 mg of albendazole , administered on consecutive days ; oxantel pamoate at a single dose of 20 mg per kilogram ; albendazole at a single dose of 400 mg ; or mebendazole at a single dose of 500 mg .
METHODS	We assessed the efficacy and safety profile of oxantel pamoate-albendazole when used in the treatment of T. trichiura infection ( primary outcome ) and concomitant soil-transmitted helminth infection ( secondary outcome ) .
METHODS	Efficacy was determined by means of assessment of the cure rate and egg-reduction rate .
METHODS	Adverse events were assessed four times after treatment .
RESULTS	Complete data were available for 458 children , of whom 450 were infected with T. trichiura , 443 with hookworm , and 293 with A. lumbricoides .
RESULTS	The cure rate of T. trichiura infection was significantly higher with oxantel pamoate-albendazole than with mebendazole ( 31.2 % vs. 11.8 % , P = 0.001 ) , as was the egg-reduction rate ( 96.0 % [ 95 % confidence interval { CI } , 93.5 to 97.6 ] vs. 75.0 % [ 95 % CI , 64.2 to 82.0 ] ) .
RESULTS	The cure rate with albendazole ( 2.6 % ) and the egg-reduction rate with albendazole ( 45.0 % ; 95 % CI , 32.0 to 56.4 ) were significantly lower than the rates with mebendazole ( P = 0.02 for the comparison of cure rates ) .
RESULTS	Oxantel pamoate had low efficacy against hookworm and A. lumbricoides .
RESULTS	Adverse events ( mainly mild ) were reported by 30.9 % of all children .
CONCLUSIONS	Treatment with oxantel pamoate-albendazole resulted in higher cure and egg-reduction rates for T. trichiura infection than the rates with standard therapy .
CONCLUSIONS	( Funded by the Medicor Foundation and the Swiss National Science Foundation ; Current Controlled Trials number , ISRCTN54577342 . )

###24403492
OBJECTIVE	The aim of the current study was to analyze the type of variations in expression profiles of matrix metalloproteinase 2 ( MMP2 ) , matrix metalloproteinase 9 ( MMP9 ) , tissue inhibitor of metalloproteinase 2 ( TIMP2 ) , and vascular endothelial growth factor A ( VEGFA ) before and after radiochemotherapy in patients with locally advanced FIGO stage Ib-IIb cervical cancer .
OBJECTIVE	We analyzed the role of these biomarkers in monitoring response to treatment .
METHODS	Serum from 72 patients with cervical cancer treated within a phase III trial with either simultaneous radiochemotherapy ( S-RC ) with cisplatin , or systemic paclitaxel and carboplatin followed by percutaneous radiation ( PC-R ) was analyzed by ELISA .
METHODS	Sera were obtained during surgery and after the end of adjuvant treatment .
RESULTS	The median age at time of diagnosis was 46 years ( range = 30-71 years ) .
RESULTS	The most common histological types were squamous cell ( 73.6 % ) and adenocarcinoma ( 25 % ) .
RESULTS	Thirty-five ( 48.6 % ) patients underwent surgery followed by S-RC and 37 ( 51.4 % ) patients were treated with surgery followed by PC-R .
RESULTS	Five patients developed recurrence within six months after radiochemotherapy .
RESULTS	VEGFA levels were significantly higher before and after adjuvant treatment in patients who developed early recurrence ( p = 0.001 ) .
RESULTS	An increase of more than 500 pg/ml VEGFA and a decrease of more than 9 % of the pre-therapeutic value of TIMP2 were significantly associated with a higher risk of early recurrence ( RR = 8.5 , 95 % CI = 1.8-39 .8 and RR = 11.0 , 95 % CI = 2.5-48 .2 , respectively ) .
RESULTS	TIMP2 expression and risk score for early relapse ( which is calculated using values of VEGFA and TIMP2 ) were independent prognostic factors for overall survival ( p = 0.043 , HR = 0.96 , 95 % CI = 0.93-0 .99 and p = 0.002 , HR = 1.09 , 95 % CI = 1.03-1 .15 , respectively ) .
CONCLUSIONS	Our results indicate a predictive value of VEGFA and TIMP2 in monitoring cervical cancer patients undergoing radiochemotherapy .

###25304934
BACKGROUND	Lumbosacral radicular syndrome ( LRS ) is a self-limiting , benign , painful and impairing condition caused by lumbar disc herniation and inflammatory processes around the nerve root .
BACKGROUND	Segmental epidural steroid injections ( SESIs ) are helpful to reduce radicular pain on a short-term basis .
BACKGROUND	It is unknown whether SESIs are an effective addition to usual pain treatment of LRS in general practice .
BACKGROUND	In our study , we assessed the effectiveness of SESIs on pain and disability as an addition to usual care for acute LRS in general practice .
METHODS	A pragmatic , single-blinded , randomized controlled trial in Dutch general practice was conducted .
METHODS	Circumstances of daily practice were closely followed .
METHODS	Care as usual ( CAU ) was compared to care as usual combined with an additional SESI in 63 patients in the acute phase of LRS .
METHODS	To detect a minimal clinically important difference of 1.2 points on a numerical rating scale for back pain and a common within-group standard deviation of 1.7 with a two-tailed alpha of 0.05 and a power of 0.80 , we needed 33 subjects in each group .
METHODS	Statistical analysis was carried out using mixed models .
RESULTS	A small significant effect in favour of the intervention , corrected for age , sex and baseline values , was found for back pain , impairment and Roland-Morris disability score .
RESULTS	The differences , though statistically significant , were too small to be considered clinically relevant .
RESULTS	Patients from the intervention group were significantly more satisfied with the received treatment than patients from the control group .
CONCLUSIONS	We found a small , statistically significant , but not clinically relevant positive effect of SESIs on back pain , impairment and disability in acute LRS .
CONCLUSIONS	We do not recommend implementing SESIs as an additional regular treatment option in general practice .

###25038355
OBJECTIVE	Antiretroviral preexposure prophylaxis ( PrEP ) , using tenofovir disoproxil fumarate ( TDF ) and combination emtricitabine/tenofovir disoproxil fumarate ( FTC+TDF ) , is efficacious for prevention of human immunodeficiency virus ( HIV ) acquisition .
OBJECTIVE	PrEP could reduce periconception HIV risk , but the effect on pregnancy outcomes is not well defined .
OBJECTIVE	To assess pregnancy incidence and outcomes among women using PrEP during the periconception period .
METHODS	Randomized trial among 1785 HIV-serodiscordant heterosexual couples ( the Partners PrEP Study ) in which the female partner was HIV uninfected that demonstrated that PrEP was efficacious for HIV prevention , conducted between July 2008 and June 2013 at 9 sites in Kenya and Uganda .
METHODS	Daily oral TDF ( n = 598 ) , combination FTC+TDF ( n = 566 ) , or placebo ( n = 621 ) through July 2011 , when PrEP demonstrated efficacy for HIV prevention .
METHODS	Thereafter , participants continued receiving active PrEP without placebo .
METHODS	Pregnancy testing occurred monthly and study medication was discontinued when pregnancy was detected .
METHODS	Pregnancy incidence , birth outcomes ( live births , pregnancy loss , preterm birth , congenital anomalies ) , and infant growth .
RESULTS	A total of 431 pregnancies occurred .
RESULTS	Pregnancy incidence was 10.0 per 100 person-years among women assigned placebo , 11.9 among those assigned TDF ( incidence difference , 1.9 ; 95 % CI , -1.1 to 4.9 [ P = .22 vs placebo ] ) , and 8.8 among those assigned FTC+TDF ( incidence difference , -1.3 ; 95 % CI , -4.1 to 1.5 [ P = .39 vs placebo ] ) .
RESULTS	Before discontinuation of the placebo treatment group in July 2011 , the occurrence of pregnancy loss ( 96 of 288 pregnancies ) was 42.5 % for women receiving FTC+TDF compared with 32.3 % for those receiving placebo ( difference for FTC+TDF vs placebo , 10.2 % ; 95 % CI , -5.3 % to 25.7 % ; P = .16 ) and was 27.7 % for those receiving TDF alone ( difference vs placebo , -4.6 % ; 95 % CI , -18.1 % to 8.9 % ; P = .46 ) .
RESULTS	After July 2011 , the frequency of pregnancy loss ( 52 of 143 pregnancies ) was 37.5 % for FTC+TDF and 36.7 % for TDF alone ( difference , 0.8 % ; 95 % CI , -16.8 % to 18.5 % ; P = .92 ) .
RESULTS	Occurrence of preterm birth , congenital anomalies , and growth throughout the first year of life did not differ significantly for infants born to women who received PrEP vs placebo .
CONCLUSIONS	Among HIV-serodiscordant heterosexual African couples , differences in pregnancy incidence , birth outcomes , and infant growth were not statistically different for women receiving PrEP with TDF alone or combination FTC+TDF compared with placebo at conception .
CONCLUSIONS	Given that PrEP was discontinued when pregnancy was detected and that CIs for the birth outcomes were wide , definitive statements about the safety of PrEP in the periconception period can not be made .
CONCLUSIONS	These results should be discussed with HIV-uninfected women receiving PrEP who are considering becoming pregnant .
BACKGROUND	clinicaltrials.gov Identifier : NCT00557245 .

###24773615
BACKGROUND	Tribulus terrestris as a herbal remedy has shown beneficial aphrodisiac effects in a number of animal and human experiments .
BACKGROUND	This study was designed as a randomized double-blind placebo-controlled trial to assess the safety and efficacy of Tribulus terrestris in women with hypoactive sexual desire disorder during their fertile years .
BACKGROUND	Sixty seven women with hypoactive sexual desire disorder were randomly assigned to Tribulus terrestris extract ( 7.5 mg/day ) or placebo for 4weeks .
BACKGROUND	Desire , arousal , lubrication , orgasm , satisfaction , and pain were measured at baseline and after 4weeks after the end of the treatment by using the Female Sexual Function Index ( FSFI ) .
BACKGROUND	Two groups were compared by repeated measurement ANOVA test .
RESULTS	Thirty women in placebo group and thirty women in drug group completed the study .
RESULTS	At the end of the fourth week , patients in the Tribulus terrestris group had experienced significant improvement in their total FSFI ( p < 0.001 ) , desire ( p < 0.001 ) , arousal ( p = 0.037 ) , lubrication ( p < 0.001 ) , satisfaction ( p < 0.001 ) and pain ( p = 0.041 ) domains of FSFI .
RESULTS	Frequency of side effects was similar between the two groups .
CONCLUSIONS	Tribulus terrestris may safely and effectively improve desire in women with hypoactive sexual desire disorder .
CONCLUSIONS	Further investigation of Tribulus terrestris in women is warranted .

###24629303
BACKGROUND	Patients who undergo cardiac catheterization or percutaneous coronary intervention ( PCI ) often have a poor understanding of their disease and of related therapeutic risks , benefits , and alternatives .
BACKGROUND	This pilot study was undertaken to compare the effectiveness of 2 preprocedural educational approaches to enhance patients ' knowledge of standard consent elements .
METHODS	Patients undergoing first-time elective , outpatient cardiac catheterization and possible PCI were randomly assigned to a scripted verbal or written consent process ( group I ) or a web-based , audiovisual presentation ( group II ) .
METHODS	Preconsent and postconsent questionnaires were administered to evaluate changes in patients ' self-reported understanding of standard consent elements .
RESULTS	One hundred and two patients enrolled at a single institution completed the pre - and postconsent surveys ( group I = 48 ; group II = 54 ) .
RESULTS	Changes in patient comprehension rates were similar between groups for risk and benefit consent elements , but group II had significantly greater improvement in the identification of treatment alternatives than group I ( p = 0.028 ) .
RESULTS	Independent of intervention , correct identification of all risks and alternatives increased significantly after consent ( p < 0.05 ) ; 4 of 5 queried risks were correctly identified by greater than 90 % of respondents .
RESULTS	However , misperceptions of benefits persisted after consent ; increased survival and prevention of future myocardial infarction were identified as PCI-related benefits by 83 % and 46 % of respondents , respectively .
CONCLUSIONS	Although both scripted verbal and audiovisual informed consent improved patient comprehension , important patient misperceptions regarding PCI-related outcomes and alternatives persist , independent of informed consent approach , and considerable challenges still exist in educating patients about contemplated medical procedures .
CONCLUSIONS	Future research appears warranted to improve patient comprehension .

###25582043
BACKGROUND	Epidemiological data on the prevalence of headache in nursing staff in Mainland China are lacking .
BACKGROUND	We therefore performed a study to assess the prevalence of headache , and factors associated with headaches , in nursing staff in three hospitals in North China .
METHODS	Stratified random cluster sampling was used to select 1102 nurses from various departments in three hospitals .
METHODS	A structured questionnaire was used to collect epidemiological data , headache characteristics and associated factors .
RESULTS	The response rate was 93.0 % .
RESULTS	Among nursing staff , the 1-year prevalence of primary headache disorders was 45.3 % , of migraine 14.8 % ( migraine with aura 3.4 % , migraine without aura 11.4 % ) , of tension-type headache ( TTH ) 26.2 % , of chronic daily headache ( CDH ) 2.7 % .
RESULTS	Multivariate analysis showed that seniority ( 5 years ) was a risk factor for migraine ( OR 2.280 ) , obesity ( BMI25 ) was a risk factor for TTH and CDH ( OR 1.684 and 3.184 ) , and age ( 40 years ) was a risk factor for CDH ( OR 8.455 ) .
RESULTS	Nurses working in internal medicine were more likely to suffer CDH than those in other departments .
RESULTS	Working a greater number of night shifts was also associated with increased prevalence of headache .
CONCLUSIONS	The prevalence of primary headache disorders in nurses is higher than that in the general population in China , and occupational factors may play an important role .
CONCLUSIONS	Therefore , the prevalence of headache in nurses should be a focus of attention , and coping strategies should be provided .
CONCLUSIONS	Such measures could contribute to improving patient care .

###25556611
OBJECTIVE	This open-label study evaluated the effects of fentanyl buccal tablet ( FBT ) on functioning and mood in cancer patients with breakthrough cancer pain ( BTcP ) .
METHODS	Opioid-tolerant patients in seven European countries with up to four BTcP episodes/day received FBT doses ( 100-800 g ) identified during open-label titration to treat up to eight BTcP episodes during an open-label treatment period .
METHODS	In countries where FBT was not commercially available , patients could enter an open-label continuation phase .
METHODS	Functionality and satisfaction assessments included change from baseline to the end of the treatment period in the modified Brief Pain Inventory ( BPI-7S ) seven-item interference subscale , patient 's global assessment of satisfaction and ease of use , and Patient 's Global Impression of Change ( PGIC ) .
METHODS	Safety was also assessed .
RESULTS	Of 330 randomized patients , 218 completed the treatment period and 88 entered the continuation phase .
RESULTS	Median background pain intensity was 4.0 ( mild ) throughout the study .
RESULTS	After the treatment period , mean ( SD ) global modified BPI-7S score improved from 39.7 ( 15.9 ) at baseline to 31.6 ( 16.8 ) for a mean change of -8.6 ( 95 % confidence interval CI -10.5 , -6.7 ; P < 0.0001 ) , and 74.5 % of patients reported improvement in overall status ( PGIC ) compared with 25.5 % who reported no change or worsening ( P < 0.001 ) .
RESULTS	Treatment-related adverse events ( 2 patients ) during the continuation phase were application site erythema ( 6.9 % ) , application site swelling ( 4.6 % ) , and vertigo ( 4.6 % ) .
CONCLUSIONS	FBT may improve patient functioning , mood , and overall satisfaction in the management of BTcP .
CONCLUSIONS	Long-term data did not indicate new safety concerns with FBT doses up to 800 g.

###25096691
OBJECTIVE	Enteral administration of immune-modulating nutrients ( eg , glutamine , omega-3 fatty acids , selenium , and antioxidants ) has been suggested to reduce infections and improve recovery from critical illness .
OBJECTIVE	However , controversy exists on the use of immune-modulating enteral nutrition , reflected by lack of consensus in guidelines .
OBJECTIVE	To determine whether high-protein enteral nutrition enriched with immune-modulating nutrients ( IMHP ) reduces the incidence of infections compared with standard high-protein enteral nutrition ( HP ) in mechanically ventilated critically ill patients .
METHODS	The MetaPlus study , a randomized , double-blind , multicenter trial , was conducted from February 2010 through April 2012 including a 6-month follow-up period in 14 intensive care units ( ICUs ) in the Netherlands , Germany , France , and Belgium .
METHODS	A total of 301 adult patients who were expected to be ventilated for more than 72 hours and to require enteral nutrition for more than 72 hours were randomized to the IMHP ( n = 152 ) or HP ( n = 149 ) group and included in an intention-to-treat analysis , performed for the total population as well as predefined medical , surgical , and trauma subpopulations .
METHODS	High-protein enteral nutrition enriched with immune-modulating nutrients vs standard high-protein enteral nutrition , initiated within 48 hours of ICU admission and continued during the ICU stay for a maximum of 28 days .
METHODS	The primary outcome measure was incidence of new infections according to the Centers for Disease Control and Prevention ( CDC ) definitions .
METHODS	Secondary end points included mortality , Sequential Organ Failure Assessment ( SOFA ) scores , mechanical ventilation duration , ICU and hospital lengths of stay , and subtypes of infections according CDC definitions .
RESULTS	There were no statistically significant differences in incidence of new infections between the groups : 53 % ( 95 % CI , 44 % -61 % ) in the IMHP group vs 52 % ( 95 % CI , 44 % -61 % ) in the HP group ( P = .96 ) .
RESULTS	No statistically significant differences were observed in other end points , except for a higher 6-month mortality rate in the medical subgroup : 54 % ( 95 % CI , 40 % -67 % ) in the IMHP group vs 35 % ( 95 % CI , 22 % -49 % ) in the HP group ( P = .04 ) , with a hazard ratio of 1.57 ( 95 % CI , 1.03-2 .39 ; P = .04 ) for 6-month mortality adjusted for age and Acute Physiology and Chronic Health Evaluation II score comparing the groups .
CONCLUSIONS	Among adult patients breathing with the aid of mechanical ventilation in the ICU , IMHP compared with HP did not improve infectious complications or other clinical end points and may be harmful as suggested by increased adjusted mortality at 6 months .
CONCLUSIONS	These findings do not support the use of IMHP nutrients in these patients .
BACKGROUND	trialregister.nl Identifier : NTR2181 .

###24629703
BACKGROUND	Although limitation of pronation/supination following both-bone forearm fractures in children is often attributed to an angular malunion , no clinical study has compared pronation/supination and angular malalignment of the same child by analysis of prospectively collected clinical data .
OBJECTIVE	The purpose of this trial is to explore whether limitation of pronation/supination can be predicted by the degree of angular malalignment in children who sustained a both-bone forearm fracture .
METHODS	In four Dutch hospitals , children aged 16 years with a both-bone forearm fracture were prospectively followed up consecutive children for 6-9 months .
METHODS	At the final follow-up , pronation/supination and angular malunion on radiographs were determined .
RESULTS	Between January 2006 and August 2010 , a total of 410 children were prospectively followed up , of which 393 children were included for analysis in this study .
RESULTS	The mean age of the children was 8.0 ( 3.5 ) years , of which 63 % were male and 40 % fractured their dominant arm .
RESULTS	The mean time to final examination was 219 ( 51 ) days .
RESULTS	Children with a metaphyseal both-bone fracture of the distal forearm with an angular malalignment of 15 had a 9-13 % chance of developing a clinically relevant limitation ( i.e. , < 50 of pronation and/or supination ) , while children with an angular malalignment of 16 had a 60 % chance .
RESULTS	Children with diaphyseal both-bone forearm fractures with 5 of angular malalignment had a 13 % chance of developing a clinically relevant limitation , which showed no significant increase with a further increase of angular malalignment .
CONCLUSIONS	Children who sustained a both-bone forearm fracture localised in the distal metaphysis have a higher chance of developing a clinically relevant limitation of forearm rotation in case of a more severe angular malalignment , while children with a diaphyseal both-bone forearm fracture had a moderate chance of limitation , irrespective of the severity of the angular malalignment .

###25659029
OBJECTIVE	A double-blind placebo-controlled study was conducted according to EMA guidelines , to evaluate safety , tolerability and short-term treatment effects of three updosing regimens of Dermatophagoides pteronyssinus subcutaneous allergen immunotherapy .
METHODS	Forty-eight patients were randomized to groups : A ( six weekly doses ) , B ( eight weekly doses ) or C ( eight doses , two clustered doses over 3 weeks ) .
RESULTS	The most frequent adverse events were local reactions .
RESULTS	No serious adverse events were found .
RESULTS	Severe systemic reactions were reported more frequently in Group C. Decreased cutaneous responses and increased specific IgGs were shown in all active groups , even within the short-term .
CONCLUSIONS	Dermatophagoides pteronyssinus subcutaneous allergen immunotherapy in depot presentation exhibited good safety and tolerability .
CONCLUSIONS	Group A seemed to show the best profile for further clinical development .

###25583758
BACKGROUND	The treatment of symptomatic acromioclavicular joint ( ACJ ) injury in the rotator cuff ( RC ) tear has not been well clarified .
OBJECTIVE	To compare the clinical results between patients who had distal clavicle resection ( DCR ) and those who did not during RC repair .
METHODS	Randomized controlled trial ; Level of evidence , 1 .
METHODS	From August 2008 to December 2009 , a total of 56 consecutive patients ( 58 shoulders ) were included .
METHODS	All patients had either a full-thickness or high-grade ( > 50 % ) RC tear , ACJ tenderness , arthritic change visible on plain radiographs , and a positive ACJ lidocaine injection test the day before surgery .
METHODS	Patients were randomized into 2 groups : DCR and RC repair ( DCR+RCR group ) and RC repair only ( isolated RCR ) .
METHODS	Evaluation was performed preoperatively , at 6 months postoperatively , and at a final follow-up a minimum of 24 months postoperatively using the American Shoulder and Elbow Surgeons ( ASES ) score , the Constant shoulder score , range of motion examination , and pain visual analog scale ( VAS ) .
RESULTS	After simple randomization , 26 shoulders were allocated in the DCR+RCR group , and 32 were placed in the isolated RCR group .
RESULTS	Five shoulders in the DCR+RCR group and 6 in the isolated RCR group were excluded from analysis due to loss of follow-up .
RESULTS	Therefore , the evaluation was performed for 21 shoulders in the DCR+RCR group and 26 shoulders in the isolated RCR group .
RESULTS	The mean follow-up period was 44.2 months in the DCR+RCR group and 44.0 months in the isolated RCR group .
RESULTS	There were no differences in age , sex , symptom duration , RC tear size , or preoperative ASES , Constant , and VAS scores between the 2 groups ( P > .05 ) .
RESULTS	At final follow-up , the ASES , Constant , and VAS scores were significantly improved in both groups ( P < .001 ) .
RESULTS	There were no differences in ASES , Constant , and VAS scores between the 2 groups at final follow-up ( P > .05 ) , and there was no difference in residual ACJ tenderness ( 7 in the DCR+RCR group and 5 in the isolated RCR group ) between the 2 groups ( P = .270 ) .
CONCLUSIONS	There was no difference in the clinical evaluations between the combined arthroscopic DCR and RCR group and the isolated RCR group at a minimum 24-month follow-up .
CONCLUSIONS	Arthroscopic DCR should be carefully considered in patients who have symptomatic ACJ arthritis with RC tears .

###25261813
BACKGROUND	Although catheter ablation is an effective rhythm control strategy for atrial fibrillation ( AF ) , empirically-based ablation has a substantial recurrence rate .
BACKGROUND	The purposes of this study were to develop a computational platform for patient-specific virtual AF ablation and to compare the anti-fibrillatory effects of 5 different virtual ablation protocols with empirically chosen clinical ablations .
METHODS	We included 20 patients with AF ( 65 % male , 60.110.5 years old , 80 % persistent AF [ PeAF ] ) who had undergone empirically-based catheter ablation : circumferential pulmonary vein isolation ( CPVI ) for paroxysmal AF ( PAF ) and additional posterior box lesion ( L1 ) and anterior line ( L2 ) for PeAF .
METHODS	Using patient-specific three-dimensional left atrial ( LA ) geometry , we generated a finite element model and tested the AF termination rate after 5 different virtual ablations : CPVI alone , CPVI+L 1 , CPVI+L 1,2 , CPVI with complex fractionated atrial electrogram ( CFAE ) ablation , and CFAE ablation alone .
RESULTS	1 .
RESULTS	Virtual CPVI+L 1,2 ablation showed the highest AF termination rate in overall patients ( 55 % ) and PeAF patients ( n = 16 , 62.5 % ) .
RESULTS	2 .
RESULTS	The virtual AF maintenance duration was shortest in the case of virtual CPVI+L 1,2 ablation in overall patients ( 2.191.28 vs. 2.911.04 s , p = 0.009 ) and in patients with PeAF ( 2.051.23 vs. 2.9310.2 s , p = 0.004 ) compared with other protocols .
CONCLUSIONS	Virtual AF ablation using personalized in-silico model of LA is feasible .
CONCLUSIONS	Virtual ablation with CPVI+L 1,2 shows the highest antifibrillatory effect , concordant with the empirical ablation protocol in patients with PeAF .

###25444531
OBJECTIVE	To investigate the effectiveness of Lactobacillus reuteri DSM 17938 for the treatment of infantile colic in breastfed Canadian infants , compared with placebo .
METHODS	A randomized , double-blind , placebo-controlled trial was conducted involving 52 infants with colic , according to modified Wessel criteria , who were assigned at random to receive L reuteri DSM 17938 ( 10 ( 8 ) colony-forming units ) ( n = 24 ) or placebo ( n = 28 ) for 21 days .
METHODS	Daily crying and fussing times were recorded in a structured diary , and maternal questionnaires were completed to monitor changes in infant colic symptoms and adverse events .
RESULTS	Total average crying and fussing times throughout the study ( from baseline to day 21 ) were significantly shorter among infants with colic in the probiotic group compared with infants in the placebo group ( 1719 750 minutes [ 29 13 hours ] vs 2195 764 minutes [ 37 13 hours ] ; P = .028 ) ( relative risk , 0.78 ; 95 % CI , 0.58-0 .98 ) .
RESULTS	Infants given L reuteri DSM 17938 showed a significant reduction in daily crying and fussing times at the end of treatment period compared with those receiving placebo ( median , 60 minutes/day [ IQR , 64 minutes/day ] vs 102 minutes/day [ IQR , 87 minutes/day ] ; P = .045 ) .
RESULTS	On day 21 , a significantly higher proportion of infants in the L reuteri DSM 17938 group responded to treatment with a 50 % crying time reduction compared with infants given placebo ( 17 vs 6 , P = .035 ; relative risk , 3.3 ; 95 % CI , 1.55-7 .03 ) .
CONCLUSIONS	Administration of L reuteri DSM 17938 significantly improved colic symptoms by reducing crying and fussing times in breastfed Canadian infants with colic .

###24289799
BACKGROUND	Tendinopathy is a difficult problem to manage and can result in significant patient morbidity .
BACKGROUND	Currently , the clinical use of platelet-rich plasma ( PRP ) in painful tendons is widespread but its efficacy remains controversial .
METHODS	This study is a single-center , randomized double-blind controlled trial .
METHODS	Eighty patients will be allocated to have ultrasound ( US ) - guided needling combined with a leukocyte-depleted ( that is , pure ) PRP or lidocaine each alternate week for a total of two interventions .
METHODS	Outcome data will be collected before intervention , and at 6 weeks , 3 , 6 , and 12 months after intervention .
METHODS	Changes in pain and activity levels , as assessed by Disabilities of the Arm , Shoulder and Hand ( DASH-E , Spanish version ) score , at 6 months .
METHODS	We will compare the percentage of patients in each group that achieve a successful treatment defined as a reduction of at least 25 % in the DASH-E score .
METHODS	Secondary outcome measures include changes in DASH-E at 3 and 12 months , changes in pain as assessed by the visual analogue scale ( VAS ) at the 6-week , 3 - , 6 - , and 12-month follow-up , changes in sonographic features and neovascularity , and percentage of patients in each group with adverse reactions at 3 , 6 , and 12 months .
CONCLUSIONS	The results of this study will provide insights into the effect of pure PRP in tendon and may contribute to identifying the best protocol for PRP application in tendinopathies .
BACKGROUND	ClinicalTrials.gov : NCT01945528 .

###24630905
OBJECTIVE	In Japan nursing care lags behind the growing population of patients with malignant pleural mesothelioma .
OBJECTIVE	This study evaluated an educational program for nurses about caring for patients with malignant pleural mesothelioma in Japan .
METHODS	In this randomized controlled study relative to care for malignant pleural mesothelioma , Knowledge , Difficulties and Attitude were measured at baseline , at post-test and at follow-up one month later .
METHODS	The two-day program with a half-day follow-up program included lectures , group work , role-playing and group discussion .
METHODS	188 participants were randomly assigned to the intervention group ( program , n = 96 ) and control group ( n = 92 ; self-study by a similar content handbook ) .
METHODS	At baseline the groups showed no statistical differences in Knowledge ( p = 0.921 ) , Difficulty ( p = 0.458 ) and Attitude ( p = 0.922 ) .
METHODS	Completing the study were 177 participants yielding 88 in the intervention group and 89 in the control group .
METHODS	Human rights and privacy of participants were protected .
RESULTS	The Knowledge score was significantly higher in the intervention post-test ( t = 14.03 , p = 0.000 ) and follow-up test ( t = 8.98 , p = 0.000 ) .
RESULTS	Difficulty score was significantly lower in the intervention at post-test ( t = -3.41 , p = 0.001 ) and follow-up test ( t = -3.70 , p = 0.000 ) .
RESULTS	The Attitude score was significantly higher in the intervention post-test ( t = 7.11 , p = 0.000 ) and follow-up test ( t = 4.54 , p = 0.000 ) .
RESULTS	The two-way analysis of variance with repeated measures on time showed an interaction between time and group ; the subsequent simple main effect test found significant differences ( p = 0.000-0 .001 ) between groups for after-program and at follow-up and a significant difference ( p = 0.000 ) in time only within the intervention group .
CONCLUSIONS	The educational program was effective in improving the nurses ' knowledge and attitude toward malignant pleural mesothelioma care and decreasing the difficulty in MPM care , therefore this program has potential for nurses ' in-service education throughout Japan .

###24606105
BACKGROUND	Discontinuation of anti-hyperglycemic oral agents and initiation of insulin is recommended in certain clinical situations for inpatients with type 2 diabetes ( T2D ) .
BACKGROUND	The effects on glucose turnover when these agents are acutely withdrawn are poorly understood and may be of importance when insulin therapy is initiated .
OBJECTIVE	Our objective was to investigate alterations in glucose turnover after acute withdrawal of noninsulin therapy .
METHODS	This was a randomized crossover study at a clinical research facility .
METHODS	Participants included 12 insulin-naive subjects with T2D .
METHODS	Subjects attended two 24-hour visits .
METHODS	Standard therapy was discontinued and replaced by closed-loop insulin delivery during the intervention visit .
METHODS	Usual anti-hyperglycemic therapy was continued during the control visit .
METHODS	Systemic glucose appearance ( Ra ) and glucose disposal ( Rd ) were measured using a tracer dilution technique with iv [ 6,6 - ( 2 ) H2 ] glucose .
RESULTS	Plasma glucose profiles during both visits were comparable ( P = .48 ) .
RESULTS	Glucose Ra increased during the day ( 21.4 [ 19.5 , 23.5 ] vs 18.6 [ 17.0 , 21.6 ) mol/kg/min , P = .019 ) and decreased overnight ( 9.7 [ 8.5 , 11.4 ] vs 11.6 [ 10.3 , 12.9 ] mol/kg/min , P = .004 ) when the usual therapy was discontinued and replaced with insulin .
RESULTS	Increased daytime glucose Rd ( 21.2 [ 19.4 , 23.9 ] vs 18.8 [ 18.3 , 21.7 ] mol/kg/min , P = .002 ) and decreased overnight Rd ( 10.4 [ 9.1 , 12.0 ] vs 11.8 [ 10.7 , 13.7 ] mol/kg/min , P = .005 ) were observed when the usual therapy was discontinued , whereas daytime peripheral insulin sensitivity was reduced ( 47.8 [ 24.8 , 66.1 ] vs 62.5 [ 34.8 , 75.8 ] nmol/kg/min per pmol/L , P = .034 ) .
CONCLUSIONS	In T2D , acute discontinuation of anti-hyperglycemic therapy and replacement with insulin increases postprandial Ra and reduces peripheral insulin sensitivity .
CONCLUSIONS	Insulin dose initiation may need to compensate for these alterations .

###24574444
OBJECTIVE	To evaluate the effect of perioperative gabapentin treatment for the prevention of persistent post-thoracotomy pain and to establish whether gabapentin has a significant therapeutic impact on acute postoperative pain .
METHODS	Consecutive patients with pulmonary malignancies scheduled for anterior thoracotomy were enrolled in this randomized , double-blinded , placebo-controlled trial .
METHODS	Patients were given 1200 mg gabapentin or placebo 2 h before surgery followed by increasing doses during 5 postoperative days : 600 mg for day 1 ; 900 mg for day 2 ; and 1200 mg for days 3-5 .
METHODS	Effective pain relief was provided with perioperative multimodal analgesia with epidural infusion of bupivacaine and morphine for 72 h , and oral acetaminophen , ibuprofen and morphine .
METHODS	The main outcome was persistent post-thoracotomy pain at 6 months .
METHODS	Secondary outcomes included measures of early postoperative post-thoracotomy pain , morphine requirements , recovery and analgesia-related adverse effects over the first 3 weeks as well as persistent post-thoracotomy pain at 3 months .
RESULTS	A total of 104 patients were randomly assigned to the intervention or control group ; 86 ( 83 % ) patients were available for the 14-day analysis , 76 ( 73 % ) for the 3-month analysis and 67 ( 64 % ) for the 6-month follow-up .
RESULTS	At 6 months postoperatively , 47 % of patients treated with gabapentin reported persistent post-thoracotomy pain compared with 49 % in the placebo group ( P = 0.9 ) .
RESULTS	No overall clinically or statistically significant differences were observed between groups receiving placebo and gabapentin , respectively , for the secondary outcome measures and treatment-related adverse events .
CONCLUSIONS	We found no evidence for the superiority of gabapentin over placebo for the treatment of acute pain following thoracotomy or for the prevention of persistent post-thoracotomy pain .

###24281852
OBJECTIVE	We previously reported an inverse association between flavonoid intake and breast cancer incidence , which has been confirmed by others , but no studies have considered simultaneously potential interactions of flavonoids with multiple genetic polymorphisms involved in biologically relevant pathways ( oxidative stress , carcinogen metabolism , DNA repair , and one-carbon metabolism ) .
METHODS	To estimate interaction effects between flavonoids and 13 polymorphisms in these four pathways on breast cancer risk , we used population-based data ( n = 875 cases and 903 controls ) and several statistical approaches , including conventional logistic regression and semi-Bayesian hierarchical modeling ( incorporating prior information on the possible biologic functions of genes ) , which also provides biologic pathway-specific effect estimates .
RESULTS	Compared to the standard multivariate model , the results from the hierarchical model indicate that gene-by-flavonoid interaction estimates are attenuated , but more precise .
RESULTS	In the hierarchical model , the average effect of the deleterious versus beneficial gene , controlling for average flavonoid intake in the DNA repair pathway , and adjusted for the three other biologically relevant pathways ( oxidative stress , carcinogen metabolism , and one-carbon metabolism ) , resulted in a 27 % increase risk for breast cancer [ odds ratio = 1.27 ; 95 % confidence interval ( CI ) = 0.70 , 2.29 ] .
RESULTS	However , the CI was wide .
CONCLUSIONS	Based on results from the semi-Bayesian model , breast cancer risk may be influenced jointly by flavonoid intake and genes involved in DNA repair , but our findings require confirmation .

###25042213
BACKGROUND	Improvement in quality of life ( QOL ) is a long term goal of drug treatment .
BACKGROUND	Although some brief interventions have been found to reduce illicit drug use , no trial among adult risky ( moderate non-dependent ) drug users has tested effects on health-related quality of life .
METHODS	A single-blind randomized controlled trial of patients enrolled from February 2011 to November 2012 was conducted in waiting rooms of five federally qualified health centers .
METHODS	413 adult primary care patients were identified as risky drug users using the WHO-ASSIST and 334 ( 81 % response ; 171 intervention , 163 control ) consented to participate in the trial .
METHODS	Three-month follow-ups were completed by 261 patients ( 78 % ) .
METHODS	Intervention patients received the QUIT intervention of brief clinician advice and up to two drug-use health telephone sessions .
METHODS	The control group received usual care and information on cancer screening .
METHODS	Outcomes were three-month changes in the Short Form Health Survey ( SF-12 ) mental health component summary score ( MCS ) and physical health component summary score ( PCS ) .
RESULTS	The average treatment effect ( ATE ) was non-significant for MCS ( 0.2 points , p-value = 0.87 ) and marginally significant for PCS ( 1.7 points , p-value = 0.08 ) .
RESULTS	The average treatment effect on the treated ( ATT ) was 0.1 ( p-value = 0.93 ) for MCS and 1.9 ( p-value = 0.056 ) for PCS .
RESULTS	The effect on PCS was stronger at higher ( above median ) baseline number of drug use days : ATE = 2.7 , p-value = 0.04 ; ATT = 3.21 , p-value = 0.02 .
CONCLUSIONS	The trial found a marginally significant effect on improvement in PCS , and significant and stronger effect on the SF-12 physical component among patients with greater frequency of initial drug use .

###25599690
BACKGROUND	In subjects with hypercholesterolaemia , cholesterol values remain above guideline levels .
BACKGROUND	One of the limiting factors to the achievement of goals in such patients is therapeutic non-adherence .
BACKGROUND	The aim of this study is to assess the effectiveness of an intervention designed to improve control of hypercholesterolaemic patients , consisting of a combined strategy that would include the delivery of printed information , treatment-compliance check cards and the dispatch of text messages as complementary measures in support of the intervention at the general practitioner 's practice .
METHODS	A randomised , parallel-group clinical trial will be conducted at the family medicine outpatient facilities of eight health centres in three of Spain 's Autonomous Regions ( Comunidades Autnomas ) , covering a total of 358 subjects aged 18years or over with diagnosis of hypercholesterolaemia .
METHODS	Patients in the intervention group will be supplied with printed material with information on the disease and its management , mobile-telephone text messages with guideline summaries , reminders of forthcoming appointments and/or arrangements for making new appointments in the event of non-attendance , and self-report cards to check compliance with recommendations .
METHODS	Both groups - intervention and control - will receive routine recommendations from their physicians in accordance with current European clinical practice guidelines for hypercholesterolaemia and cardiovascular risk management .
METHODS	As regards the measurements to be made , the main variable is the proportion of subjects who attain the low density lipoprotein cholesterol levels set as a target across a follow-up period of 24months .
METHODS	The secondary variables are as follows : adherence to recommendations on lifestyle and adherence to drug treatment ; variation in lipid profiles and cardiovascular risk levels ; appearance of cardiovascular events ; physical activity ; food consumption ; smoking habit ; anthropometric measures ; blood pressure ; health problems ; use of hypolipidaemic agents ; socio-demographic data ; beliefs and expectations about preventive recommendations ; and degree of satisfaction with the combined strategy .
CONCLUSIONS	Should this intervention prove effective , a recommendation could be issued on the application of this combined strategy to subjects with hypercholesterolaemia .
CONCLUSIONS	It is a simple , relatively inexpensive intervention .
BACKGROUND	ClinicalTrials.gov : NCT02314663 .

###25162603
OBJECTIVE	In vitro : To assess the effect of common crushing techniques on particle size reduction ( PSR ) and in vitro drug-release kinetics of oxycodone DETERx ( herein DETERx ) and of a commercially available oxycodone extended-release ( ER ) tablet .
OBJECTIVE	In vivo : To evaluate the impact of the most effective manipulation method identified in the in vitro study and the effect of chewing on the pharmacokinetics ( PK ) of DETERx relative to oxycodone solution .
METHODS	In vitro : Mechanical manipulation of dosage forms using common household utensils .
METHODS	In vivo : Open-label , randomized , active-controlled , crossover PK study .
METHODS	In vivo : Forty-four healthy male and female volunteers .
METHODS	In vitro : DETERx capsule contents and marketed comparator tablets were subjected to manipulation ( crushing ) using 10 different household utensils .
METHODS	Particle size and dissolution analysis were conducted .
METHODS	In vivo : Subjects were randomly assigned to receive DETERx 40-mg capsules intact , crushed , or chewed or oxycodone solution .
METHODS	Serial blood samples were drawn for PK assessment .
RESULTS	In vitro : The utensils used to manipulate DETERx capsule contents were either ineffective in reducing the particle size or produced only a small change in the median particle size and dissolution rate relative to the marketed comparator .
RESULTS	In vivo : DETERx intact capsules provided significantly lower Cmax and longer Tmax values than oxycodone solution .
RESULTS	Manipulation of DETERx by crushing ( using the most effective method established in vitro ) or chewing resulted in bioequivalent plasma concentration-time profiles to the intact dosage form .
CONCLUSIONS	These mechanical manipulation and PK studies demonstrated that DETERx beads retained their ER properties after mechanical tampering and chewing by study subjects .

###25022111
OBJECTIVE	To observe the impacts of acupoint catgut embedding therapy and acupuncture-moxibustion therapy on the long-term efficacy and patient 's life quality in the treatment of allergic rhinitis .
METHODS	Sixty-nine patients were randomized into the combined acupuncture-moxibustion and acupoint catgut embedding therapy group ( combined therapy group , 36 cases ) and an acupuncture-moxibustion group ( 33 cases ) .
METHODS	In the acupuncture-moxibustion group , acupuncture was applied at Yingxiang ( LI 20 ) , Shangyingxiang ( EX-HN 8 ) , Yintang ( GV 29 ) , Shangxing ( GV 23 ) , Tongtian ( BL 7 ) and Zusanli ( ST 36 ) .
METHODS	Moxibustion was applied at Zusanli ( ST 36 ) , Feishu ( BL 13 ) , Dazhui ( GV 14 ) and Fengmen ( BL 12 ) .
METHODS	In the combined therapy group , on the basis of the treatment as acupuncture-moxibustion group , the catgut embedding therapy was applied at Feishu ( BL 13 ) , Fengmen ( BL 12 ) , Pishu ( BL 20 ) , Shenshu ( BL 23 ) , Zhongwan ( CV 12 ) and Qihai ( CV 6 ) .
METHODS	The treatment duration was 4 weeks in the two groups .
METHODS	The clinical efficacy of allergic rhinitis and rhinoconjunctivitis quality of life questionnaire ( RQLQ ) score were observed before and after treatment as well as in the 4-weeks follow-up after the end of treatment respectively .
RESULTS	The markedly effective rate was 72.7 % ( 24/33 ) in the combined therapy group and 48.4 % ( 15/31 ) in the acupuncture-moxibustion group after treatment .
RESULTS	The efficacy was similar between the two groups ( P > 0.05 ) .
RESULTS	It was 57.6 % ( 19/33 ) in the combined therapy group and was 22.6 % ( 7/31 ) in the 4-week follow-up after treatment , indicating the long-term efficacy in the combined therapy group was superior to that in the acupuncture-moxibustion group ( P < 0.05 ) .
RESULTS	Scores of RQLO after treatment and in 4-week follow-up after treatment in both groups were improved as compared with those before treatment ( all P < 0.05 ) .
RESULTS	In 4-week follow-up , the improvements in sleep and affection in the combined therapy group were superior to the acupuncture-moxibustion group ( 3.27 + / - 3.23 vs 4.61 + / - 3.56 , 3.48 + / - 3.67 vs 5.81 + / - 4.15 , both P < 0.05 ) .
CONCLUSIONS	The acupoint catgut embedding therapy combined with acupuncture-moxibustion therapy are safe and effective in the treatment of allergic rhinitis and display the more roles in the long-term efficacy .

###24919587
BACKGROUND	Osteoarthritis is a chronic disease with a multifactor etiology involving changes in bone alignment , cartilage , and other structures necessary to joint stability .
BACKGROUND	There is a need to investigate therapeutic resources that combine different wavelengths as well as different light sources ( low-level laser therapy and light-emitting diode therapy ) in the same apparatus for the treatment of osteoarthritis .
BACKGROUND	The aim of the proposed study is to analyze the effect of the incorporation of phototherapy into a therapeutic exercise program for individuals with osteoarthritis of the knee .
METHODS	A double-blind , controlled , randomized clinical trial will be conducted involving patients with osteoarthritis of the knee .
METHODS	Evaluations will be performed using functional questionnaires before and after the treatment protocols , in a reserved room with only the evaluator and participant present , and no time constraints placed on the answers or evaluations .
METHODS	The following functional tests will also be performed : stabilometry ( balance assessment ) , dynamometry ( muscle strength of gluteus medius and quadriceps ) , algometry ( pain threshold ) , fleximeter ( range of motion ) , timed up-and-go test ( functional mobility ) , and the functional reach test .
METHODS	The participants will then be allocated to three groups through a randomization process using opaque envelopes : exercise program , exercise program + phototherapy , or exercise program + placebo phototherapy , all of which will last for eight weeks .
CONCLUSIONS	The purpose of this randomized clinical trial is to analyze the effect of the incorporation of phototherapy into a therapeutic exercise program for osteoarthritis of the knee .
CONCLUSIONS	The study will support the practice based on evidence to the use of phototherapy in individuals with a diagnosis of osteoarthritis of the knee .
CONCLUSIONS	Data will be published after the study is completed .
BACKGROUND	The protocol for this study has been submitted to Clinical Trials , registration number NCT02102347 , on 29 March 2014 .

###25141240
BACKGROUND	Prescription opioids have substantial abuse potential .
BACKGROUND	This study compared the positive subjective drug effects of a newly developed extended-release ( ER ) oxycodone ( OC ) / acetaminophen ( acetyl-para-aminophenol [ APAP ] ) formulation with those of immediate-release ( IR ) OC/APAP .
METHODS	This randomized , double-blind , active - and placebo-controlled , 7-way crossover study enrolled healthy volunteers who were recreational prescription opioid users .
METHODS	The protocol was approved by an institutional review board and all participants provided written informed consent .
METHODS	Participants received single doses of intact ER and IR OC/APAP 15/650 mg , intact ER and IR OC/APAP 30/1300 mg , crushed ER and IR OC/APAP 30/1300 mg , and placebo .
METHODS	Peak subjective effects ( Emax ) , time to Emax , and area under the drug-effect curves for drug liking , drug high , and good drug effects were measured using visual analogue scales .
METHODS	Least squares means with 95 % confidence interval were compared using analysis of variance .
RESULTS	Among completers ( N = 55 ) , intact ER OC/APAP produced delayed and lower peak effects versus IR OC/APAP .
RESULTS	Comparing intact tablets , the drug liking Emax ( least squares means [ 95 % confidence interval ] ) was significantly lower for OC/APAP 30/1300 mg ( 76.4 [ 72.8 to 80.0 ] ) than for IR OC/APAP 30/1300 mg ( 85.6 [ 81.9 to 89.2 ] ; difference , -9.2 [ -13.1 to -5.2 ] ; P < 0.001 ) .
RESULTS	Similar results were observed for intact ER and IR OC/APAP ( 15 mg/650 mg ) .
RESULTS	Crushing ER OC/APAP 30/1300 mg further delayed these effects compared with the same dose of crushed IR OC/APAP and intact ER OC/APAP .
CONCLUSIONS	Extended-release OC/APAP produced lower subjective drug effects than IR OC/APAP .
CONCLUSIONS	Crushing ER OC/APAP further delayed onset of subjective effects compared with intact ER OC/APAP .
CONCLUSIONS	The ER OC/APAP may be less attractive for abuse than IR OC/APAP .
BACKGROUND	This phase 1 study conducted in the United States was not registered .

###25473945
OBJECTIVE	Teleophthalmology has the potential to reduce costs and inconveniences associated with frequent patient visits .
OBJECTIVE	Evaluating teleophthalmology in the management of age-related macular degeneration ( AMD ) will allow for future implementation of this technology .
OBJECTIVE	To evaluate teleophthalmology as a tool for the screening and monitoring of neovascular AMD .
METHODS	Prospective , randomized clinical trial that included 106 referral eyes for suspected neovascular AMD and 63 eyes with stable neovascular AMD .
METHODS	New referrals for patients with suspected neovascular AMD and patients with stable neovascular AMD were randomized into either routine or teleophthalmologic groups .
METHODS	In the routine group , patients received clinical assessment and diagnostic imaging at a tertiary hospital-based retina clinic .
METHODS	In the teleophthalmologic group , patients received basic examination and diagnostic imaging at a stand-alone teleophthalmologic site , where patient information and imaging studies were acquired and electronically sent over to tertiary hospital-based retina specialists .
METHODS	Patients in the teleophthalmologic group were called back to the tertiary treatment center if the teleophthalmologic data set suggested pathology or was inconclusive for diagnosis .
METHODS	Patient wait times for diagnosis and/or treatment , referral accuracy , and visual outcome .
RESULTS	For neovascular AMD screening , the average referral-to-diagnostic imaging time was 22.5 days for the teleophthalmologic group and 18.0 days for the routine group , for a difference of 4.5 days ( 95 % CI , 11.8 to -2.8 days ; P = .23 ) .
RESULTS	The average diagnostic imaging to treatment time was 16.4 days for the teleophthalmologic group and 11.6 days for the routine group , for a difference of 4.8 days ( 95 % CI , 10.7 to -1.1 days ; P = .11 ) .
RESULTS	For neovascular AMD monitoring , the average recurrence to treatment time was shorter for the routine group ( 0.04 days ) compared with 13.6 days for the teleophthalmologic group , for a difference of -13.5 days ( 95 % CI , -18.2 to -9.0 days ; P < .01 ) .
RESULTS	There was no difference identified between end-of-study visual acuities in the 2 groups ( P = .99 ) .
CONCLUSIONS	A delay of referral to treatment time could not be identified when comparing teleophthalmologic screening for suspected neovascular AMD with retinal specialist-based screening .
CONCLUSIONS	Teleophthalmologic monitoring for neovascular AMD recurrence resulted in longer wait times for treatment reinitiation , but no adverse visual outcomes were identified .
BACKGROUND	clinicaltrials.gov Identifier : NCT01581606 .

###24297381
OBJECTIVE	To evaluate safety and efficacy of weekly ( qw ) and every other week ( q2w ) dosing of sarilumab , a fully human anti-interleukin 6 receptor ( anti-IL-6R ) monoclonal antibody , for moderate-to-severe rheumatoid arthritis ( RA ) .
METHODS	In this dose-ranging study , patients ( n = 306 ) with active RA , despite methotrexate , were randomly assigned to placebo or one of five subcutaneous doses/regimens of sarilumab : 100mg q2w , 150mg q2w , 100mg qw , 200mg q2w , 150mg qw for 12weeks , plus methotrexate .
METHODS	The primary end point was ACR20 at Week 12 .
METHODS	Secondary endpoints included ACR50 , ACR70 , Disease Activity Score in 28 joints ( C reactive protein ) .
METHODS	Safety , pharmacokinetics , pharmacodynamics and efficacy in population subgroups were assessed .
RESULTS	The proportion of patients achieving an ACR20 response compared with placebo was significantly higher for sarilumab 150mg qw ( 72.0 % vs 46.2 % , multiplicity adjusted p = 0.0203 ) .
RESULTS	Higher ACR20 responses were also attained with 150mg q2w ( 67 % ; unadjusted ( nominal ) p = 0.0363 ) and 200mg q2w ( 65 % ; unadjusted p = 0.0426 ) versus placebo .
RESULTS	Sarilumab 150mg q2w reduced C reactive protein , which did not return to baseline between dosing intervals .
RESULTS	Infections were the most common adverse event ; none were serious .
RESULTS	Changes in laboratory values ( neutropenia , transaminases and lipids ) were consistent with reports with other IL-6R inhibitors .
CONCLUSIONS	Sarilumab improved signs and symptoms of RA over 12weeks in patients with moderate-to-severe RA with a safety profile similar to reports with other IL-6 inhibitors .
CONCLUSIONS	Sarilumab 150mg and sarilumab 200mg q2w had the most favourable efficacy , safety and dosing convenience and are being further evaluated in Phase III .

###24610876
BACKGROUND	We examined risk of newly detected human papillomavirus ( HPV ) infection and cervical abnormalities in relation to HPV type 16/18 antibody levels at enrollment in PATRICIA ( Papilloma Trial Against Cancer in Young Adults ; NCT00122681 ) .
METHODS	Using Poisson regression , we compared risk of newly detected infection and cervical abnormalities associated with HPV-16 / 18 between seronegative vs seropositive women ( 15-25 years ) in the control arm ( DNA negative at baseline for the corresponding HPV type [ HPV-16 : n = 8193 ; HPV-18 : n = 8463 ] ) .
RESULTS	High titers of naturally acquired HPV-16 antibodies and/or linear trend for increasing antibody levels were significantly associated with lower risk of incident and persistent infection , atypical squamous cells of undetermined significance or greater ( ASCUS + ) , and cervical intraepithelial neoplasia grades 1/2 or greater ( CIN1 + , CIN2 + ) .
RESULTS	For HPV-18 , although seropositivity was associated with lower risk of ASCUS + and CIN1 + , no association between naturally acquired antibodies and infection was demonstrated .
RESULTS	Naturally acquired HPV-16 antibody levels of 371 ( 95 % confidence interval [ CI ] , 242-794 ) , 204 ( 95 % CI , 129-480 ) , and 480 ( 95 % CI , 250-5756 ) EU/mL were associated with 90 % reduction of incident infection , 6-month persistent infection , and ASCUS + , respectively .
CONCLUSIONS	Naturally acquired antibodies to HPV-16 , and to a lesser extent HPV-18 , are associated with some reduced risk of subsequent infection and cervical abnormalities associated with the same HPV type .

###25211297
BACKGROUND	Children with severe cutaneous burn injury show persistent metabolic abnormalities , including inflammation and insulin resistance .
BACKGROUND	Such abnormalities could potentially increase their future risk for developing type 2 diabetes mellitus ( T2DM ) and cardiovascular disease ( CVD ) .
BACKGROUND	This could be related to changes in body composition and fat distribution .
METHODS	We studied body composition , fat distribution , and inflammatory cytokines changes in children with severe burn injury up to 6 months from discharge .
METHODS	Sixty-two boys and 35 girls ( burn 30 % of total body surface area ) were included .
RESULTS	We found a decrease in total body fat and subcutaneous peripheral fat at 6 months ( 6 % and 2 % , respectively ; P < 0.05 each ) .
RESULTS	An inverse correlation between the decrease in peripheral fat content at 6 months and the extent of burn injury ( r = -041 , P = 0.02 ) was also observed .
RESULTS	In addition , there was a 12 % increase in serum tumor necrosis factor - ( TNF - ) ( P = 0.01 vs. discharge ) and 9 % decrease in serum interleukin-10 ( IL-10 ) ( P < 0.0001 vs. discharge ) over 6 months after burn .
CONCLUSIONS	Severe burn injury in children is associated with changes in body fat content and distribution up to 6 months from hospital discharge .
CONCLUSIONS	These changes , accompanied by persisting systemic inflammation , could possibly mediate the observed persistence of insulin resistance , predisposing burn patients to the development of T2DM and CVD .

###24636118
OBJECTIVE	To integrate group-based lifestyle sessions ( GBLS ) within prenatal care for gestational weight gain ( GWG ) management .
METHODS	In Study 1 , participants attended GBLS during prenatal care visits .
METHODS	Participants in Study 2 attended off-site GBLS whereby care providers were asked to discuss the program with patients .
METHODS	Process and outcome evaluation were conducted through a mixed-methods approach .
RESULTS	In both pre-experimental feasibility studies , data provide preliminary support for GBLS ( eg , positive care provider and patient feedback , weight gain patterns ) as well as highlight areas for future research ( eg , lack of GWG management discussions , preference for GBLS location ) .
CONCLUSIONS	GBLS represents a promising approach to GWG management .
CONCLUSIONS	Future research should assess the generalizability , sustainably , and compatibility of GBLS within prenatal care .

###25786369
OBJECTIVE	Secondary hyperparathyroidism ( SHPT ) is a frequent complication of chronic kidney disease .
OBJECTIVE	We evaluated AMG 416 , a long-acting peptide agonist of the calcium-sensing receptor , to assess its safety , tolerability , and efficacy and to determine a safe and effective starting dose for subsequent phase 2 studies .
OBJECTIVE	The study was not designed to titrate AMG 416 dosing to achieve a specific PTH treatment goal .
METHODS	This is a multicenter , double-blind , randomized , placebo-controlled , dose-escalation study designed to evaluate the safety and efficacy of AMG 416 administered thrice weekly by IV bolus at the end of hemodialysis for up to 4 weeks .
METHODS	Eligible subjects were enrolled in one of three cohorts and treated with 5mg of AMG 416 or placebo for 2 weeks ( Cohort 1 ) or 5 or 10mg of AMG 416 or placebo for 4 weeks ( Cohorts 2 and 3 ) .
METHODS	The primary endpoint was mean percentage change from baseline in PTH during the efficacy assessment phase ( EAP ) in Cohorts 2 and 3 .
RESULTS	Analysis of the primary endpoint showed that treatment with AMG 416 at 10mg ( Cohort 2 ) and 5mg ( Cohort 3 ) for up to 4 weeks resulted in mean 49.4 % and 33.0 % reductions from baseline in PTH during the efficacy assessment phase , respectively ( p < 0.05 for both cohorts compared to placebo group within the cohort ) .
RESULTS	A substantial proportion of subjects treated with AMG 416 achieved PTH 300pg/mL and 30 % reduction in PTH from baseline in both cohorts .
RESULTS	The observed decreases in serum-corrected calcium were well tolerated and serum phosphate levels also tended to decrease .
CONCLUSIONS	The present clinical findings support the continued development of AMG 416 as a treatment for SHPT in hemodialysis patients .

###24854808
OBJECTIVE	Although there is general agreement that parents should be involved in pediatric obesity treatment , few studies have investigated the effectiveness of interventions that target parents exclusively .
OBJECTIVE	Moreover , the effectiveness of this approach has not been adequately assessed with racially diverse families , particularly African Americans ( AA ) , a group at high risk for elevated Body Mass Index ( BMI ) .
METHODS	NOURISH ( Nourishing Our Understanding of Role modeling to Improve Support and Health ) is a culturally-sensitive parenting intervention targeting overweight ( AA ) children ( ages 6-11 ; MBMI = 98.0 % ile ) .
METHODS	Families ( N = 84 ; 61 % AA , 37 % White ) were randomly assigned to NOURISH or a control group .
RESULTS	NOURISH families significantly improved on child BMI from pre - to post-testing after adjustment for random effects , baseline BMI , and child race .
RESULTS	NOURISH parents were very satisfied with the intervention and would recommend it to other parents ; 91 % strongly or moderately agreed that NOURISH helped them eat in a healthier manner .
CONCLUSIONS	These pilot data suggest that NOURISH is acceptable and , with refinement , offers promise for reducing pediatric BMI .
CONCLUSIONS	Outcomes , lessons learned , and parent feedback will inform a larger randomized controlled trial .

###24988873
OBJECTIVE	The eradication rate of 10-day sequential therapy for Helicobacter pylori ( H. pylori ) infection was not satisfactory in Korea , probably due to antibiotic resistance .
OBJECTIVE	To compare the treatment efficacy of 15-day and 10-day sequential therapy of conventional 7-day proton pump inhibitor ( PPI ) triple therapy for the treatment of H. pylori infection .
METHODS	A total of 332 patients with H. pylori infection were randomly assigned to receive either 7-day PPI triple therapy , 10-day sequential therapy or 15-day sequential therapy .
METHODS	Eradication rate , drug compliance , and adverse events were compared among the three regimens .
RESULTS	The eradication rates by intention-to-treat analysis were 64.3 % ( 95 % CI : 55.5-73 .2 ; 74 of 115 patients ) , 72.1 % ( 95 % CI : 63.6-80 .5 ; 80 of 111 patients ) , and 80.2 % ( 95 % CI : 72.5-87 .9 ; 85 of 106 patients ) in the 7-day PPI triple , 10-day and 15-day sequential therapy groups , respectively ( p = 0.032 ) .
RESULTS	The eradication rates by per-protocol analysis were 68.5 % ( 95 % CI : 59.6-77 .4 ; 74 of 108 patients ) , 78.4 % ( 95 % CI : 70.3-86 .5 ; 80 of 102 patients ) , and 89.5 % ( 95 % CI : 83.2-95 .8 ; 85 of 95 patients ) in the 7-day PPI triple , 10-day and 15-day sequential therapy groups , respectively ( p = 0.001 ) .
RESULTS	There were no statistically significant differences between the three eradication therapy groups in regard to drug compliance and adverse events .
CONCLUSIONS	The 15-day sequential therapy demonstrated improved eradication efficacy compared with 7-day PPI triple and 10-day sequential therapy in Korea .

###24780614
OBJECTIVE	We aimed to assess the impact of eplerenone on cardiovascular ( CV ) outcomes in STEMI without known heart failure , when initiated within 24 h of symptom onset .
RESULTS	In this randomized , placebo-controlled , double-blind trial , we assigned 1012 patients with acute STEMI and without a history of heart failure to receive either eplerenone ( 25-50 mg once daily ) or placebo in addition to standard therapy .
RESULTS	The primary endpoint was the composite of CV mortality , re-hospitalization , or , extended initial hospital stay , due to diagnosis of HF , sustained ventricular tachycardia or fibrillation , ejection fraction 40 % , or elevated BNP/NT-proBNP at 1 month or more after randomization .
RESULTS	BNP elevation was defined as BNP levels or values above 200 pg/mL or NT-proBNP values above 450 pg/mL ( in patients aged below 50 ) ; above 900 pg/mL ( age 50-75 years ) or above 1800 pg/mL ( patients older than 75 ) .
RESULTS	After a mean follow-up of 10.5 months , the primary endpoint occurred in 92 patients ( 18.2 % ) in the eplerenone group and in 149 patients ( 29.4 % ) in the placebo group [ adjusted hazard ratio ( HR ) , 0.58 ; 95 % confidence interval ( CI ) , 0.45-0 .76 ; P < 0.0001 ] .
RESULTS	The primary endpoint was driven by a high BNP/NT-proBNP level ( adjusted HR , 0.60 ; 95 % CI , 0.45-0 .79 ; P < 0.0003 ) .
RESULTS	Adverse event rates were similar in both groups .
RESULTS	Serum potassium levels exceeded 5.5 mmol/L in 5.6 vs. 3.2 % ( P = 0.09 ) and were below 3.5 mmol/L in 1.4 vs. 5.6 % of patients ( P = 0.0002 ) , in the eplerenone and placebo groups , respectively .
CONCLUSIONS	The addition of eplerenone during the acute phase of STEMI was safe and well tolerated .
CONCLUSIONS	It reduced the primary endpoint over a mean 13 months follow-up mostly because of significantly lower BNP/NT-proBNP levels .
CONCLUSIONS	Additional studies are needed to clarify the role of early use of MRAs in STEMI patients without heart failure .
BACKGROUND	NCT01176968 .

###25217098
BACKGROUND	Weight-loss trials tend to recruit highly selective , non-representative samples .
BACKGROUND	Effective weight-loss approaches are needed for real-world challenging populations .
OBJECTIVE	To test whether a small-changes intervention , delivered in groups or via telephone , promotes greater weight loss than standard obesity treatment in a predominantly male , high-risk Veteran population .
OBJECTIVE	Data were collected in 2010-2012 and analyzed in 2013 .
METHODS	A three-arm , 12-month randomized pragmatic effectiveness trial .
METHODS	Four-hundred eighty-one overweight/obese participants from two Midwestern Veterans Affairs ( VA ) Medical Centers were randomly assigned to one of three programs : the 12-month Aspiring to Lifelong Health ( ASPIRE ) weight-loss program delivered ( 1 ) individually over the phone ( ASPIRE-Phone ) or ( 2 ) in-person group sessions ( ASPIRE-Group ) ; compared to ( 3 ) VA 's standard weight-loss program ( MOVE ! )
METHODS	Twenty-eight sessions with a non-clinician coach via telephone or in-person groups using a small-changes obesity treatment approach compared to a 15-30-session standard VA program .
METHODS	Twelve-month change in weight ( kilograms ) .
RESULTS	Participants in all three arms lost significant ( p < 0.01 ) weight at 12 months .
RESULTS	Participants in the ASPIRE-Group arm lost significantly more weight at 12 months than those in the other two treatment arms ( -2.8 kg , 95 % CI = -3.8 , -1.9 , in ASPIRE-Group vs -1.4 kg , 95 % CI = -2.4 , -0.5 , in ASPIRE-Phone and -1.4 kg , 95 % CI = -2.3 , -0.4 ) in MOVE !
RESULTS	( ) .
RESULTS	ASPIRE-Group resulted in greater improvements in all other anthropometric measures compared to MOVE !
RESULTS	at 12 months ( p < 0.05 ) and for all ( p < 0.05 ) but waist circumference ( p = 0.23 ) compared to ASPIRE-Phone .
CONCLUSIONS	Group-based delivery of the ASPIRE weight management program is more effective than MOVE !
CONCLUSIONS	and the phone-based version of ASPIRE at promoting sustained weight loss in a predominantly male population with multiple comorbidities .
CONCLUSIONS	The incremental benefits of group-based ASPIRE over the current MOVE !
CONCLUSIONS	program could yield significant population-level benefits if implemented on a large scale .

###25086281
BACKGROUND	Disorders of homocysteine and B-vitamin metabolism represent a significant problem in clinical practice .
BACKGROUND	Establishing the diagnosis requires specialized tests with demanding preanalytical requirements .
BACKGROUND	To advance the detection of patients with these disorders , we developed a method for the simultaneous determination of cystathionine ( Cysta ) , methionine ( Met ) and total homocysteine ( tHcy ) in dried blood spots ( DBSs ) .
METHODS	A punch from a DBS sample was mixed with a solution of isotopically labeled internal standards , and analytes were extracted using methanol/0 .1 % formic acid/0 .5 mol/L dithiothreitol .
METHODS	The extract was injected into an LC-MS/MS system operating in MRM mode .
RESULTS	The analytical performance of the method employing DBS is adequate for its purpose and the type of sample .
RESULTS	Compared with Cysta , tHcy and Met plasma levels , our method exhibited a negative bias between -3.8 % and -42.2 % due to the lower concentrations of these analytes in erythrocytes .
RESULTS	The tHcy level and the Met/Cysta ratio in DBS enabled the clear detection of 12 patients with disorders of transsulfuration and with genetic and nutritional remethylation defects .
CONCLUSIONS	The ease of collecting and transporting DBS samples may advance diagnostic procedures in patients with neuropsychiatric disorders and thromboembolism .
CONCLUSIONS	Consequently , this approach may facilitate detection and simplify the monitoring of patients with homocystinuria .

###24530134
BACKGROUND	The effects of short course of corticosteroids on the metabolic processes and bone formation has not been well studied .
BACKGROUND	Our aim was to compare the efficacy , the side effects and the bone and lipid metabolisms in IBD patients using bolus or conventional tapering of methylprednisolone for 12 weeks .
METHODS	Nineteen IBD patients received intravenous methylprednisolone of 1mg/kg for 5 days tapered by 4 mg per week .
METHODS	Patients were prospectively randomized in two groups .
METHODS	In `` conventional '' group ( I ) steroids were given daily .
METHODS	In `` pulse '' group ( II ) weekly doses of steroids were given on special days of the week .
METHODS	The body mass index ( BMI ) was measured before and after the corticosteroid therapy .
METHODS	Blood samples were collected to assess glucose level , electrolytes , cholesterol and triglyceride levels , inflammatory parameters , cortisol , osteocalcin and crosslaps values .
METHODS	Total body composition analysis was performed at the beginning and at the end of the steroid therapy .
RESULTS	In Group I , BMI increased , total body bone density decreased significantly at the end of the steroid therapy .
RESULTS	Body fat percent showed a tendency to be higher at the end of steroid therapy in Group I. Cholesterol level increased significantly in Group I patients .
RESULTS	The decrease in serum cortisol level was more remarkable in Group I vs. Group II after steroid therapy .
RESULTS	Less side-effect occurred in Group II vs. Group I.
CONCLUSIONS	Our results suggest that bolus tapering of corticosteroids may have more favorable short term outcome than conventional tapering that may revolutionize steroid therapy in IBD .

###25863559
BACKGROUND	Compared with other countries , patients with chronic hepatitis C infection in Japan tend to be older , have more advanced liver disease , and are more likely to have been previously treated for hepatitis C.
BACKGROUND	We aimed to assess the efficacy and safety of an all-oral , fixed-dose combination of the hepatitis C virus NS5A inhibitor ledipasvir and the NS5B nucleotide polymerase inhibitor sofosbuvir with and without ribavirin for 12 weeks in treatment-naive and previously treated Japanese patients with chronic genotype 1 hepatitis C virus infection .
METHODS	In this randomised , open-label study , we enrolled patients from 19 clinical Japanese centres .
METHODS	Patients were randomly assigned ( 1:1 ) to receive either ledipasvir ( 90 mg ) and sofosbuvir ( 400 mg ) or ledipasvir , sofosbuvir , and ribavirin ( dosed according to the Japanese Copegus product label-ie , patients 60 kg received 600 mg daily , patients > 60 kg to 80 kg received 800 mg daily , and patients > 80 kg received 1000 mg daily ) orally once daily for 12 weeks .
METHODS	After completion or early discontinuation of treatment , patients were followed up off-treatment for 24 weeks .
METHODS	Eligible patients were at least 20 years of age with chronic genotype 1 hepatitis C virus infection with serum hepatitis C virus RNA concentrations of at least 5 log10 IU/mL , creatinine clearance of at least 10 mL/s , and a platelet count of at least 5010 ( 9 ) per L.
METHODS	An interactive web response system was used to manage patient randomisation and treatment assignment .
METHODS	Randomisation was stratified by the presence or absence of cirrhosis for treatment-naive patients and stratified by presence or absence of cirrhosis and by previous treatment category ( relapser or breakthrough , non-responder , or interferon-intolerant ) for previously treated patients .
METHODS	Within each strata , patients were sequentially assigned to either treatment with ledipasvir-sofosbuvir or ledipasvir-sofosbuvir plus ribavirin in a 1:1 ratio with block size of 4 .
METHODS	The primary endpoint was sustained virological response 12 weeks after completion of treatment ( SVR12 ) assessed in all patients who were randomly assigned and received at least one dose of study drug ; safety outcomes were assessed in all patients who received at least one dose of study drug .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01975675 .
RESULTS	Between Oct 15 , 2013 and Dec 13 , 2013 , 341 patients were randomly assigned to treatment groups and received at least one dose of study treatment .
RESULTS	SVR12 was achieved in all 171 ( 100 % ) patients ( 83 of 83 treatment naive and 88 of 88 treatment experienced ) receiving ledipasvir-sofosbuvir ( 95 % CI 98-100 ) and 167 ( 98 % ) of 170 patients ( 80 of 83 treatment naive and 87 of 87 treatment experienced ) receiving ledipasvir-sofosbuvir plus ribavirin ( 95 % CI 95-100 ) .
RESULTS	Of the 76 patients with baseline NS5A resistant variants , 75 ( 99 % ) achieved SVR12 .
RESULTS	Two ( 12 % ) of 170 patients in the ledipasvir-sofosbuvir plus ribavirin group discontinued treatment because of adverse events .
RESULTS	The most common adverse events were nasopharyngitis ( 50 [ 292 % ] of 171 ) , headache ( 12 [ 70 % ] of 171 ) , and malaise ( nine [ 53 % ] of 171 ) in patients receiving ledipasvir-sofosbuvir ; and nasopharyngitis ( 40 [ 235 % ] of 170 ) , anaemia ( 23 [ 135 % ] of 170 ) , and headache in those receiving ledipasvir-sofosbuvir and ribavirin ( 15 [ 88 % ] of 170 ) .
CONCLUSIONS	Although existing regimens for the treatment of hepatitis C virus are effective for many patients , medical needs remain unmet , particularly in Japan where the population with hepatitis C virus genotype 1 is generally older and treatment-experienced , with advanced liver disease .
CONCLUSIONS	The efficacy , tolerability , and absence of drug-drug interactions of ledipasvir-sofosbuvir suggest that it could be an important option for treatment of genotype 1 hepatitis C virus in Japanese patients .
BACKGROUND	Gilead Sciences .

###25017530
BACKGROUND	The effect of fluticasone furoate nasal spray ( FFNS ) on growth in prepubescent children has not been evaluated .
OBJECTIVE	To characterize the difference in mean prepubescent growth velocities , as determined by stadiometry , between patients treated continuously for 1 year with FFNS 110mcg once daily and placebo nasal spray .
METHODS	This was a multicenter , randomized , double-blind , placebo-controlled , parallel-group 76-week safety study .
METHODS	Nasal symptom assessments were used as a measure of adherence .
METHODS	Eligible patients were ages 5 to < 8.5 years at screening and had at least a 1-year clinical history and diagnosis of perennial allergic rhinitis , including a positive skin test or specific IgE to an appropriate perennial allergen within the past year .
RESULTS	One hundred eighty-six patients in the FFNS group and 187 patients in the placebo group completed the entire 52-week treatment period .
RESULTS	During treatment , the least squares mean growth velocity was 5.19 cm/y for the FFNS group and 5.46 cm/y for the placebo group ; mean difference,-0 .270 cm/y ( 95 % CI,-0 .48 to-0 .06 cm/y ) .
RESULTS	Other safety assessments , including 24-hour urinary cortisol excretion , were comparable between the treatment groups .
RESULTS	Daily reflective total nasal symptom scores declined similarly in both the FFNS and placebo groups .
CONCLUSIONS	Once-daily treatment with FFNS over 52 weeks in prepubescent children resulted in a small reduction in growth velocity compared with placebo .
CONCLUSIONS	Clinicians will need to balance the reduction in growth observed with FFNS to its potential for clinical benefit .

###25064093
OBJECTIVE	To evaluate the effect of a multidisciplinary rehabilitation programme on disability , kinesiophobia , catastrophizing , pain , quality of life and gait disturbances in patients with chronic low back pain ( CLBP ) .
METHODS	This was a parallel-group , randomised , superiority-controlled pilot study in which 20 patients were randomly assigned to a programme consisting of motor training ( spinal stabilising exercises plus usual-care ) and cognitive-behavioural therapy ( experimental group , 10 subjects ) or usual-care alone ( control group , 10 subjects ) .
METHODS	Before treatment , 8 weeks later ( post-treatment ) , and 3 months after the end of treatment , the Oswestry Disability Index , the Tampa Scale for Kinesiophobia , the Pain Catastrophizing Scale , a pain numerical rating scale , and the Short-Form Health Survey were assessed .
METHODS	Spatio-temporal gait parameters were also measured by means of an electronic walking mat .
METHODS	A linear mixed model for repeated measures was used for each outcome measure .
RESULTS	The programme had significant group ( p = 0.027 ) , time ( p < 0.001 ) , and time-by-group interaction ( p < 0.001 ) effects on disability , with the experimental group showing an improvement after training of about 61 % ( 25 % in the control group ) .
RESULTS	The analyses of kinesiophobia , catastrophizing , and the quality of life also revealed significant time , group , and time-by-group interaction effects in favour of the experimental group , and there was a significant effect of time on pain .
RESULTS	Both groups showed a general improvement in gait parameters , with the experimental group increasing cadence significantly more .
CONCLUSIONS	The multidisciplinary rehabilitation programme including cognitive-behavioural therapy was superior to the exercise programme in reducing disability , kinesiophobia , catastrophizing , and enhancing the quality of life and gait cadence of patients with CLBP .

###24552320
BACKGROUND	Vascular endothelial growth factor ( VEGF ) promotes angiogenesis , a mediator of disease progression in cervical cancer .
BACKGROUND	Bevacizumab , a humanized anti-VEGF monoclonal antibody , has single-agent activity in previously treated , recurrent disease .
BACKGROUND	Most patients in whom recurrent cervical cancer develops have previously received cisplatin with radiation therapy , which reduces the effectiveness of cisplatin at the time of recurrence .
BACKGROUND	We evaluated the effectiveness of bevacizumab and nonplatinum combination chemotherapy in patients with recurrent , persistent , or metastatic cervical cancer .
METHODS	Using a 2-by-2 factorial design , we randomly assigned 452 patients to chemotherapy with or without bevacizumab at a dose of 15 mg per kilogram of body weight .
METHODS	Chemotherapy consisted of cisplatin at a dose of 50 mg per square meter of body-surface area , plus paclitaxel at a dose of 135 or 175 mg per square meter or topotecan at a dose of 0.75 mg per square meter on days 1 to 3 , plus paclitaxel at a dose of 175 mg per square meter on day 1 .
METHODS	Cycles were repeated every 21 days until disease progression , the development of unacceptable toxic effects , or a complete response was documented .
METHODS	The primary end point was overall survival ; a reduction of 30 % in the hazard ratio for death was considered clinically important .
RESULTS	Groups were well balanced with respect to age , histologic findings , performance status , previous use or nonuse of a radiosensitizing platinum agent , and disease status .
RESULTS	Topotecan-paclitaxel was not superior to cisplatin-paclitaxel ( hazard ratio for death , 1.20 ) .
RESULTS	With the data for the two chemotherapy regimens combined , the addition of bevacizumab to chemotherapy was associated with increased overall survival ( 17.0 months vs. 13.3 months ; hazard ratio for death , 0.71 ; 98 % confidence interval , 0.54 to 0.95 ; P = 0.004 in a one-sided test ) and higher response rates ( 48 % vs. 36 % , P = 0.008 ) .
RESULTS	Bevacizumab , as compared with chemotherapy alone , was associated with an increased incidence of hypertension of grade 2 or higher ( 25 % vs. 2 % ) , thromboembolic events of grade 3 or higher ( 8 % vs. 1 % ) , and gastrointestinal fistulas of grade 3 or higher ( 3 % vs. 0 % ) .
CONCLUSIONS	The addition of bevacizumab to combination chemotherapy in patients with recurrent , persistent , or metastatic cervical cancer was associated with an improvement of 3.7 months in median overall survival .
CONCLUSIONS	( Funded by the National Cancer Institute ; GOG 240 ClinicalTrials.gov number , NCT00803062 . )

###25298243
BACKGROUND	The anterolateral approach is a commonly used technique for total hip replacement .
BACKGROUND	It requires the detachment of a large part of the gluteus medius muscle .
BACKGROUND	However , it is known that this muscle has a great impact on hip stability .
BACKGROUND	Using the percutaneous assisted approach the damage to the gluteus medius can be limited .
BACKGROUND	The purpose of this study is to compare the effect of the percutaneous assisted approach with the anterolateral approach on postoperative functional outcome .
METHODS	This study uses a prospective , randomized , parallel-group design with blinded assessment and unblinded treatment to compare the percutaneous assisted approach with the anterolateral approach in total hip replacement surgery .
METHODS	The postoperative results of patients operated on using the percutaneous assisted approach will be compared with those of patients operated on using the anterolateral approach .
METHODS	Prior to surgery patients will undergo baseline measurements .
METHODS	These will consist of gluteus medius measurements ( surface-electromyography , strength measurements of abductors and quadriceps and the Trendelenburg test ) , questionnaires ( Oxford Hip Score and 36-item Short Form Health Survey ) and functional measures ( the Timed Get-Up-and-Go test , Five times Sit-to-Stand test and Six-Minute Walk test ) .
METHODS	These measurements will be repeated four and 12 weeks after surgery .
METHODS	After surgery both groups will receive usual care .
CONCLUSIONS	The gluteus medius is the main stabilizer of the hip joint .
CONCLUSIONS	Therefore , we assume that functional outcome and gluteus medius function of patients after the percutaneous assisted approach will be better than after the anterolateral approach .
BACKGROUND	This trial was registered with ClinicalTrials.gov on 8 January 2014 , registration number : NCT02032017 .

###24224779
OBJECTIVE	To determine and compare the adverse events and long-term effectiveness for patients with small hepatocellular carcinoma ( HCC ) ( 3cm ) treated by percutaneous radiofrequency ablation ( RFA ) or hepatectomy .
METHODS	Small HCC from 120 patients were randomized into either percutaneous RFA therapy or hepatectomy group , and the effectiveness and complications of two treatment modalities were analyzed .
METHODS	The complications of post-RFA or hepatectomy , the complete treatment rate , treatment-related mortality , and disease-free and overall survival rate were followed up and conducted .
RESULTS	In patients with small HCC , complete remission rates were achieved in 95 % and 96.7 % in the percutaneus RFA and hepatectomy groups , respectively ( P > 0.05 ) .
RESULTS	Hepatic function at day-7 status post-treatment , including albumin and bilirubin levels , were significantly worse in the hepatectomy group ( P < 0.01 ) .
RESULTS	Compared with the RFA group , the incidence of postoperative complications ( 27.5 % vs 5.0 % ) and hospital stay ( 11.83.1 vs 4.31.5 ) were significantly higher in the hepatectomy group ( P < 0.01 ) .
RESULTS	After a mean follow-up of 40 months , 22 patients ( 36.6 % ) in the RFA group and 21 patients ( 35.0 % ) in the hepatectomy group developed a recurrence ( P > 0.05 ) .
RESULTS	There was no significant difference of the disease-free and overall survival rates at 1 , 2 , and 3 years between the RFA group and the surgical hepatectomy group ( P = 0.443 and P = 0.207 , respectively ) .
CONCLUSIONS	In patients with small HCC , percutaneous RFA showed similar local control and long-term survival compared with hepatectomy .
CONCLUSIONS	Importantly , percutaneous RFA are accompanied with a lower complication rate and shorter hospital stay day .

###24231014
BACKGROUND	Burned patients have increased level of mortality , possibly due to late introduction of enteral feeding .
BACKGROUND	The aim of this study was to compare the benefits and safety of very early enteral nutrition introduction compared to the normal diet among burns patients in an intensive care unit .
METHODS	Participants consisted of 101 patients , aged 20-76 years ( mean age 48 years ) , 49 men and 52 women , with burns that covered more than 20 % of the body .
METHODS	The intervention group consisted of 52 subjects fed via introduced nasojejunal probe that started within four hours after admission to the hospital .
METHODS	The control group consisted of fifty patients fed in standard manner per os ( three standard hospital meals ) immediately after the first wound dressing .
RESULTS	The average decline BMI in control group was 2.270.56 kg/m2 , while the average reduction in BMI in the intervention group was 1.770.38 kg/m2 ( p < 0.001 ) .
RESULTS	The largest drop of albumin concentration in the control group was 28.5 % , whereas in the intervention group was 23.8 % .
RESULTS	( p < 0.001 ) .
RESULTS	The greatest decrease of transferrin concentration in the control group was 31.1 % , while the average reduction in the intervention group was 18.3 % .
RESULTS	( p < 0.001 ) .
RESULTS	C-reactive protein values were statistically higher in control group ( p < 0.001 ) .
RESULTS	Intervention group had lower rate of complications and infection rates .
CONCLUSIONS	Enteral nutrition in burned patients should begin within few hours of burn onset .
CONCLUSIONS	Such approach leads to better outcomes , reduces complications , and improves nutritional profile .

###25902320
BACKGROUND	The purpose of this study was to identify optimal target propofol and remifentanil concentrations to avoid a gag reflex in response to insertion of an upper gastrointestinal endoscope .
METHODS	Patients presenting for endoscopy received target-controlled infusions ( TCI ) of both propofol and remifentanil for sedation-analgesia .
METHODS	Patients were randomized to 4 groups of fixed target effect-site concentrations : remifentanil 1 ngmL ( REMI 1 ) or 2 ngmL ( REMI 2 ) and propofol 2 gmL ( PROP 2 ) or 3 gmL ( PROP 3 ) .
METHODS	For each group , the other drug ( propofol for the REMI groups and vice versa ) was increased or decreased using the `` up-down '' method based on the presence or absence of a gag response in the previous patient .
METHODS	A modified isotonic regression method was used to estimate the median effective Ce ,50 from the up-down method in each group .
METHODS	A concentration-effect ( sigmoid Emax ) model was built to estimate the corresponding Ce ,90 for each group .
METHODS	These data were used to estimate propofol bolus doses and remifentanil infusion rates that would achieve effect-site concentrations between Ce ,50 and Ce ,90 when a TCI system is not available for use .
RESULTS	One hundred twenty-four patients were analyzed .
RESULTS	To achieve between a 50 % and 90 % probability of no gag response , propofol TCIs were between 2.40 and 4.23 gmL ( that could be achieved with a bolus of 1 mgkg ) when remifentanil TCI was fixed at 1 ngmL , and target propofol TCIs were between 2.15 and 2.88 gmL ( that could be achieved with a bolus of 0.75 mgkg ) when remifentanil TCI was fixed at 2 ngmL .
RESULTS	Remifentanil ranges were 1.00 to 4.79 ngmL and 0.72 to 3.19 ngmL when propofol was fixed at 2 and 3 gmL , respectively .
CONCLUSIONS	We identified a set of propofol and remifentanil TCIs that blocked the gag response to endoscope insertion in patients undergoing endoscopy .
CONCLUSIONS	Propofol bolus doses and remifentanil infusion rates designed to achieve similar effect-site concentrations can be used to prevent gag response when TCI is not available .

###24280344
OBJECTIVE	Total atrial conduction time ( TACT ) is the most important parameter in predicting the development of new-onset atrial fibrillation .
OBJECTIVE	We investigated the effect of cilostazol therapy on TACT in patients with peripheral artery disease .
METHODS	Thirty patients with peripheral artery disease were treated with cilostazol ( 200 mg/day ) for 6 months .
METHODS	The baseline echocardiographic total atrial conduction time parameter was compared with the 6-month follow-up .
RESULTS	The TACT duration was decreased in all patients compared with the baseline after therapy ( 121.8 19.3 vs. 109.1 15.9 milliseconds , p < 0.001 ) .
RESULTS	However , left atrial ( LA ) diameter was not changed with the therapy .
RESULTS	The reduction of TACT duration was correlated with the increase in mitral E wave velocity/mitral A wave velocity ratio ( r = -0.48 , p < 0.003 ) .
CONCLUSIONS	Our results showed that 200 mg cilostazol treatment decreased TACT duration in patients with peripheral artery disease , which may also prevent the development and/or recurrence of atrial fibrillation ( AF ) .

###25458650
BACKGROUND	Protease-activated receptor 1 antagonism with vorapaxar represents a novel strategy for platelet inhibition .
BACKGROUND	In TRACER , vorapaxar was compared with placebo plus standard of care among 12,944 patients with non-ST-segment elevation acute coronary syndromes .
BACKGROUND	We anticipated that most patients would have received clopidogrel as part of standard care .
BACKGROUND	We investigated the modification of vorapaxar 's effect associated with clopidogrel use over time .
METHODS	The marginal structural model method was used to estimate causal modification of vorapaxar effect by use of clopidogrel over time .
METHODS	The primary outcomes were the composite of cardiovascular death , myocardial infarction , or stroke and Global Use of Strategies to Open Occluded Coronary Arteries moderate or severe bleeding .
METHODS	The event accrual period excluded the time during which clopidogrel was clinically warranted .
RESULTS	Among 12,887 patients who received study medication , 11,117 ( 86.3 % ) received clopidogrel before randomization , of whom 38.5 % stopped later in the trial ( median time to stoppage 200 days with placebo ; interquartile range [ IQR ] 14-367 ) ( 186 days with vorapaxar ; IQR 17-366 ) .
RESULTS	In total , 1,770 ( 13.7 % ) patients were not on clopidogrel at randomization , of whom 47.8 % started afterward ( median time to start 2 days ; IQR 2-4 ) .
RESULTS	During the period of event accrual , vorapaxar was associated with a 26 % reduction in the composite of cardiovascular death , myocardial infarction , or stroke when used with clopidogrel ( hazard ratio [ HR ] 0.74 ; 95 % CI 0.60-0 .91 ) and a 24 % reduction when used without clopidogrel ( HR 0.76 ; 95 % CI 0.56-1 .02 ) ( interaction ; P = .89 ) .
RESULTS	The hazard of Global Use of Strategies to Open Occluded Coronary Arteries bleeding with vorapaxar was not significantly different without clopidogrel ( HR 1.33 ; 95 % CI 0.81-2 .20 ) or with clopidogrel ( HR 1.09 ; 95 % CI 0.76-1 .56 ) ( interaction ; P = .53 ) .
CONCLUSIONS	We observed no interaction between vorapaxar and clopidogrel after non-ST-segment elevation acute coronary syndromes on efficacy or safety outcomes , supporting a complementary role of protease-activated receptor 1 and P2Y12 antagonism .

###25691671
OBJECTIVE	To test whether combining bevacizumab , an anti-vascular endothelial growth factor treatment , with endocrine therapy ( ET ) could potentially delay the emergence of resistance to ET .
METHODS	A multicenter , randomized , open-label , phase III , binational ( Spain and Germany ) study added bevacizumab ( 15 mg/kg every 3 weeks ) to ET ( ET-B ; letrozole or fulvestrant ) as first-line therapy in postmenopausal patients with human epidermal growth factor receptor 2 ( HER2 ) - negative and hormone receptor-positive advanced breast cancer .
METHODS	We compared progression-free survival ( PFS ) , overall survival ( OS ) , overall response rate ( ORR ) , response duration ( RD ) , time to treatment failure ( TTF ) , clinical benefit rate ( CBR ) , and safety .
RESULTS	From 380 patients recruited ( 2007 to 2011 ) , 374 were analyzed by intent to-treat ( 184 patients on ET and 190 patients on ET-B ) .
RESULTS	Median age was 65 years , 270 patients ( 72 % ) had Eastern Cooperative Oncology Group performance status of 0 , 178 patients ( 48 % ) had visceral metastases , and 171 patients ( 46 % ) and 195 patients ( 52 % ) had received prior chemotherapy or ET , respectively .
RESULTS	Median PFS was 14.4 months in the ET arm and 19.3 months in the ET-B arm ( hazard ratio , 0.83 ; 95 % CI , 0.65 to 1.06 ; P = .126 ) .
RESULTS	ORR , CBR , and RD with ET versus ET-B were 22 % versus 41 % ( P < .001 ) , 67 % versus 77 % ( P = .041 ) , and 13.3 months versus 17.6 months ( P = .434 ) , respectively .
RESULTS	TTF and OS were comparable in both arms .
RESULTS	Grade 3 to 4 hypertension , aminotransferase elevation , and proteinuria were significantly higher in the ET-B arm .
RESULTS	Eight patients ( 4.2 % ) receiving ET-B died during study or within 30 days of end of treatment .
CONCLUSIONS	The addition of bevacizumab to ET in first-line treatment failed to produce a statistically significant increase in PFS or OS in women with HER2-negative/hormone receptor-positive advanced breast cancer .

###24247616
OBJECTIVE	Secretory phospholipase A2 ( sPLA2 ) generates bioactive phospholipid products implicated in atherosclerosis .
OBJECTIVE	The sPLA2 inhibitor varespladib has favorable effects on lipid and inflammatory markers ; however , its effect on cardiovascular outcomes is unknown .
OBJECTIVE	To determine the effects of sPLA2 inhibition with varespladib on cardiovascular outcomes .
METHODS	A double-blind , randomized , multicenter trial at 362 academic and community hospitals in Europe , Australia , New Zealand , India , and North America of 5145 patients randomized within 96 hours of presentation of an acute coronary syndrome ( ACS ) to either varespladib ( n = 2572 ) or placebo ( n = 2573 ) with enrollment between June 1 , 2010 , and March 7 , 2012 ( study termination on March 9 , 2012 ) .
METHODS	Participants were randomized to receive varespladib ( 500 mg ) or placebo daily for 16 weeks , in addition to atorvastatin and other established therapies .
METHODS	The primary efficacy measure was a composite of cardiovascular mortality , nonfatal myocardial infarction ( MI ) , nonfatal stroke , or unstable angina with evidence of ischemia requiring hospitalization at 16 weeks .
METHODS	Six-month survival status was also evaluated .
RESULTS	At a prespecified interim analysis , including 212 primary end point events , the independent data and safety monitoring board recommended termination of the trial for futility and possible harm .
RESULTS	The primary end point occurred in 136 patients ( 6.1 % ) treated with varespladib compared with 109 patients ( 5.1 % ) treated with placebo ( hazard ratio [ HR ] , 1.25 ; 95 % CI , 0.97-1 .61 ; log-rank P = .08 ) .
RESULTS	Varespladib was associated with a greater risk of MI ( 78 [ 3.4 % ] vs 47 [ 2.2 % ] ; HR , 1.66 ; 95 % CI , 1.16-2 .39 ; log-rank P = .005 ) .
RESULTS	The composite secondary end point of cardiovascular mortality , MI , and stroke was observed in 107 patients ( 4.6 % ) in the varespladib group and 79 patients ( 3.8 % ) in the placebo group ( HR , 1.36 ; 95 % CI , 1.02-1 .82 ; P = .04 ) .
CONCLUSIONS	In patients with recent ACS , varespladib did not reduce the risk of recurrent cardiovascular events and significantly increased the risk of MI .
CONCLUSIONS	The sPLA2 inhibition with varespladib may be harmful and is not a useful strategy to reduce adverse cardiovascular outcomes after ACS .
BACKGROUND	clinicaltrials.gov Identifier : NCT01130246 .

###24565295
OBJECTIVE	Postoperative nausea and vomiting ( PONV ) occur frequently after laparoscopic bariatric surgery .
OBJECTIVE	The combination of haloperidol , dexamethasone , and ondansetron may reduce these undesirable events .
OBJECTIVE	The aim of this study was to evaluate the intensity of nausea and pain , the number of vomiting episodes , and morphine consumption in postoperative ( PO ) obese patients undergoing laparoscopic sleeve gastrectomy ( LSG ) .
METHODS	A clinical , randomized , controlled , double-blind study conducted with 90 patients with body mass index 35 kg.cm ( -2 ) .
METHODS	Patients were divided into three groups of 30 individuals to receive ondansetron 8 mg ( Group O ) ; ondansetron 8 mg and dexamethasone 8 mg ( Group OD ) ; and ondansetron 8 mg , dexamethasone 8 mg , and haloperidol 2mg ( Group HDO ) .
METHODS	We evaluated the intensity of nausea and pain using the verbal numeric scale , cumulative number of vomiting episodes , and morphine consumption in the period of 0-2 , 2-12 , 12-24 , and 24-36 hours postoperatively .
RESULTS	Nausea intensity was lower in Group HDO compared to Group O ( p = 0.001 ) , pain intensity was lower in Group HDO compared to Group O ( p = 0.046 ) , and morphine consumption was lower in Group HDO compared to Group O ( p = 0.037 ) .
RESULTS	There was no difference between groups regarding the number of vomiting episodes ( p = 0.052 ) .
CONCLUSIONS	The combination of haloperidol , ondansetron , and dexamethasone reduced nausea and pain intensity and morphine consumption in postoperative obese patients undergoing LSG .

###24533998
OBJECTIVE	We determined the effect of an intensive lifestyle intervention on the prevalence , incidence and resolution of bothersome nocturia , increased daytime urinary voiding and urinary incontinence in overweight/obese men with type 2 diabetes after 1 year in the Look AHEAD trial .
METHODS	A subset of male Look AHEAD participants was selected for this secondary data analysis .
METHODS	Overall 1,910 men with an average ( mean SD ) age of 59.9 6.7 years and body mass index of 35.2 5.5 kg/m ( 2 ) were randomized to an intensive lifestyle intervention or diabetes support and education group .
METHODS	All participants self-reported information regarding incontinence , nocturia and daytime urinary voiding at entry and 1 year .
RESULTS	After 1 year the intensive lifestyle intervention group lost significantly more weight than the diabetes support and education group ( 9.4 % 7.0 % vs 0.7 % 4.5 % , respectively ; p < 0.001 ) .
RESULTS	The odds of prevalent urinary incontinence at 1 year were reduced by 38 % in the intensive lifestyle intervention group compared to the diabetes support and education group .
RESULTS	The prevalence of urinary incontinence decreased from 11.3 % to 9.0 % in the intensive lifestyle intervention group and increased from 9.7 % to 11.6 % in the diabetes support and education group .
RESULTS	The intensive lifestyle intervention group also had increased odds of urinary incontinence resolving ( OR 1.93 , 95 % CI 1.04-3 .59 , p = 0.04 and 56.0 % vs 40.7 % , p = 0.03 ) and trend toward reduced odds of new onset , incident urinary incontinence ( OR 0.66 , 95 % CI 0.42-1 .02 , p = 0.06 ) compared with the diabetes support and education arm .
RESULTS	In contrast , no differences between intensive lifestyle intervention and diabetes support and education were seen at 1 year for frequency of nocturia or frequency of daytime voiding .
CONCLUSIONS	Intensive lifestyle intervention should be considered for the treatment of urinary incontinence in overweight/obese men with type 2 diabetes .

###25070824
OBJECTIVE	This study is conducted to investigate an optimal timing of sequential noninvasive positive pressure ventilation ( NPPV ) applied for patients with acute exacerbations of chronic obstructive pulmonary disease ( AECOPD ) .
METHODS	Application of NPPV for 102 patients was randomly observed in the conditions of a 2-hour spontaneous breathing trial ( SBT-2 ) and pulmonary infection control ( PIC ) window .
METHODS	Efficiency of NPPV in treatment of the patients , an incidence rate of tracheal reintubation , length of time for patients received invasive mechanical ventilation , and a morbidity rate of ventilator-associated pneumonia were examined in each group of 51 patients .
RESULTS	The incidence rates for the patients treated successfully with NPPV and for tracheal reintubation were shown as 88.2 and 60.8 , and 11.8 and 39.2 in SBT-2 and PIC , respectively ( both p < 0.05 ) .
RESULTS	Length of time ( hour ) for use of the invasive ventilation was 116 and 82.5 in SBT-2 and PIC , respectively ( p < 0.05 ) .
RESULTS	There was a similar morbidity rate of ventilator-associated pneumonia seen in both groups .
CONCLUSIONS	SBT-2 would be the optimal timing considered to use NPPV for AECOPD patients based on a high success rate and a low risk of tracheal reintubation .

###24494292
OBJECTIVE	To explore the effect of nursing intervention on the prevention of burns in warm needling moxibustion .
METHODS	Two hundred patients received warm needling treatment were collected from January to December 2011 and were randomized into an observation group and a control group , 100 cases veceived ten hundreds of treatment in each group .
METHODS	In the control group , the routine nursing was applied in warm needling moxibustion .
METHODS	In the observation group , on the basic method as the control group , the nursing intervention was used .
METHODS	The burns incidence and the satisfaction of patients in warm needling moxibustion were recorded in the patients of the two groups .
RESULTS	The burns incidence was 0.6 % ( 6/1000 ) in the observation group , which was lower apparently than 1.5 % ( 15/1000 ) in the control group ( P < 0.05 ) .
RESULTS	The satisfaction of patients in warm needling moxibustion was 99.0 % ( 99/100 ) in the observation group , which was higher obviously than 88.0 % ( 88/100 ) in the control group ( P < 0.01 ) .
CONCLUSIONS	The nursing intervention prevents effectively from burns in warm needling moxibustion , reduces medical injuries , avoids the pains of patients and plays the active role in the patient satisfaction .

###24434128
OBJECTIVE	The macro - and microcirculation disease , in patients with type 2 diabetes mellitus ( T2DM ) , induces ischemic wounds of the lower limbs .
OBJECTIVE	We have tried to reduce the aggregation of red blood cells and to improve the O2 supply to the tissues and speed the healing of ulcers in T2DM patients .
METHODS	We enrolled 25 obese subjects without glucose intolerance ( group A ; BMI greater than 30 kg/m2 ) , 20 obese adults intolerant to glucose ( group B ) and two subgroups , groups C and D , with T2DM and with leg ulcers .
METHODS	The groups A , B and C were treated with PESF .
METHODS	Body weight , O2 extraction , the capillary pulse , blood pressure and the surface of the ulcers were monitored .
RESULTS	The technique PESF shows to have positive effects on the metabolism , on the reduction of body weight in the groups A and B , increasing extraction of O2 in group C and increase the speed of healing of wounds in group C compared to group D.
RESULTS	In group A , there was a significant reduction in systolic and diastolic blood pressure .
CONCLUSIONS	The technique PESF has affected the metabolic processes and the speed of wound healing ulcer in patients with T2DM .

###25948426
OBJECTIVE	Labor induction in post-term pregnancy is considered as a conventional process of mothers ' care .
OBJECTIVE	Shiatsu technique is one of the complementary methods which use for post-term pregnancy induction .
OBJECTIVE	Therefore , the researchers decided to examine the effect of Shiatsu technique on the induction of post-term pregnancy .
METHODS	This is a randomized control trials which conducted on 288 women with post-term pregnancy who referred to consulting clinic at Ali - Ibn - Abi - Talib Hospital , in Zahedan-Iran in 2010-2011 .
METHODS	Participants were selected based on random table .
METHODS	The participants divided into two groups : the first was shiatsu technique and the second group was control group ( routine procedure ) .
METHODS	Shiatsu technique was conducted on the participants of intervention group for 30s on three points by an experienced midwife .
METHODS	The gathered data analyzed by SPSS version 15.00 and comparing tests were t-students tests , chi-square .
RESULTS	Mothers ages range were between 16 to 42 years ( mean 26.5-5 .7 ) in shiatsu and 17 to 43 years ( mean 24.5-5 .1 ) in control group .
RESULTS	Regarding spontaneous initiation of labor , 82 women ( 56.9 % ) in Shiatsu group had spontaneous initiation of labor , whereas the number of women was only 12 ( 8.3 % ) in control group .
RESULTS	Women who have used Shiatsu technique were significantly more likely to have spontaneous labour than those women who did not .
CONCLUSIONS	Results of the study showed that shiatsu technique can be used as one of safe complementary methods for post-term pregnancy induction .

###24315720
BACKGROUND	The progression of carotid intima-media thickness ( CIMT ) is closely associated with ischemic stroke recurrence .
BACKGROUND	However , the efficacy of cilostazol on preventing CIMT progression in stroke patients has never been investigated properly by a prospective trial .
METHODS	This study is a part of `` Trial of Cilostazol in Symptomatic Intracranial Arterial Stenosis-2 . ''
METHODS	Six centers that are available to measure CIMT according to the protocol participated in this substudy .
METHODS	After 7 months of randomization , the changes of CIMT were compared between cilostazol group and clopidogrel group .
METHODS	CIMT was measured by a semiautomated software ( Intimascope ) and was presented as the mean of maximum ( CIMT-max ) and average ( CIMT-ave ) of both common carotid arteries .
METHODS	Linear logistic regression analysis and analysis of covariance were performed to verify the independent factors associated with CIMT progression .
RESULTS	Among the 85 patients , 39 subjects were assigned to cilostazol group and 46 subjects to clopidogrel group .
RESULTS	Follow-up CIMT significantly decreased in cilostazol group ( CIMT-max : -.03.11 and CIMT-ave : -.02.08 ) compared with the increase in clopidogrel group ( CIMT-max : .04.20 and CIMT-ave : .04.11 ; P = .05 and P = .04 , respectively ) .
RESULTS	Female , diabetes , and smoking were independently associated with the progression of CIMT , whereas the use of cilostazol was against CIMT progression from the results of linear regression analysis ( P = .03 for both CIMT-max and CIMT-ave ) .
RESULTS	The use of cilostazol also well predicted less progression of CIMT at follow-up after adjusting for baseline CIMT values and conventional risk factors ( CIMT-max : P = .04 and CIMT-ave : P = .03 ) .
CONCLUSIONS	Cilostazol has a beneficial effect in preventing the progression of CIMT in ischemic stroke patients .

###25013996
BACKGROUND	Low-dose GH ( LGH ) therapy has been reported to improve insulin sensitivity in GH-deficient adults ; however , the mechanism is unclear .
OBJECTIVE	Effects of LGH therapy on insulin sensitivity are mediated through changes in cortisol metabolism and ectopic fat accumulation .
METHODS	This was a double-blind , placebo-controlled , parallel , 3-month study .
METHODS	Seventeen GH-deficient adults were randomized to receive either daily LGH or placebo injections .
METHODS	Fasting blood samples were collected at baseline , and months 1 and 3 , whereas hyperinsulinemic-euglycemic clamps , magnetic resonance spectroscopy scans , 24-hour cortisol production rates ( CPRs ) , and sc abdominal fat biopsies were performed at baseline and month 3 .
METHODS	Clamp glucose infusion rate , intramyocellular , extramyocellular , and intrahepatic lipid content , 24-hour CPRs , adipocyte size , and adipocyte 11-hydroxysteroid dehydrogenase activity in adults with GH deficiency were evaluated .
RESULTS	At month 1 , LGH did not alter fasting levels of glucose , insulin , C-peptide , free fatty acid , adiponectin , total IGF-1 , IGF-1 bioactivity , IGF-2 , IGF binding protein ( IGFBP ) -2 , or IGF-1 to IGFBP-3 molar ratio .
RESULTS	At month 3 , LGH increased clamp glucose infusion rates ( P < .01 ) and IGF-1 to IGFBP-3 molar ratio ( P < .05 ) , but fasting glucose , insulin , C-peptide , free fatty acid , adiponectin , IGF-1 bioactivity , IGF-2 , IGFBP-2 , 24-hour CPRs , adipocyte size , adipocyte 11-hydroxysteroid dehydrogenase activity , intrahepatic lipid , extramyocellular , or intramyocellular were unchanged .
RESULTS	In the placebo group , all within-group parameters from months 1 and 3 compared with baseline were unchanged .
CONCLUSIONS	Short-term LGH therapy improves insulin sensitivity without inducing basal lipolysis and had no effect on cortisol metabolism and ectopic fat accumulation in GH-deficient adults .
CONCLUSIONS	This may reflect an LGH-induced increase in IGF-1 to IGFBP-3 molar ratio exerting insulin-like effects through the abundant muscle IGF-1 receptors , but this hypothesis requires confirmation with further studies .

###25185430
BACKGROUND	It has been shown that serum concentrations of 1,25 ( OH ) 2D3 are decreased in patients with gout .
BACKGROUND	A short-term administration of allopurinol increases plasma concentrations of 1,25 ( OH ) 2D3 in mild to moderate renal failure , with or without hyperuricemia .
BACKGROUND	It has been reported that subjects who perform regular vigorous and / or moderate physical activities have higher plasma and serum 25 ( OH ) D3 levels .
BACKGROUND	However , little is known about the influence of allopurinol and/or physical exercise on serum 25 ( OH ) D3 concentrations in humans .
METHODS	We investigated the effect of allopurinol administration and/or physical activity on vitamin D metabolism by measuring serum uric acid , 25 ( OH ) D3 , and calcium levels in twelve professional soccer players .
RESULTS	The athletes supplemented with allopurinol , but not those who received placebo , exhibited a significant decrease in uric acid serum concentrations after the match .
RESULTS	We also found a significant increase in serum calcium and 25 ( OH ) D3 concentrations in the supplemented group .
CONCLUSIONS	We conclude that allopurinol administration might be an effective drug to lower hyperuricemia and treat hypovitaminosis D.

###25543415
OBJECTIVE	To observe the improvements in constipation differentiated as intestine system syndrome and lung system syndrome treated with electroacupuncture ( EA ) and explore their correlation .
METHODS	Seventy cases of severe functional constipation were randomized into an EA group and a pseudo-EA group , 35 cases in each one .
METHODS	In the EA group , the needles were inserted deeply at Tianshu ( ST 25 ) and Fujie ( SP 14 ) on bilateral sides , and directly went to parietal peritoneum .
METHODS	EA was attached to the needles , dense-disperse wave , 2 Hz/15 Hz , and 0.1 to 1.0 mA .
METHODS	The perpendicular insertion was done at Shangjuxu ( ST 37 ) , 25 mm in depth .
METHODS	After qi arrival , the needle was lifted , thrusted and rotated once every 10 min , for 3 times totally .
METHODS	The needles were retained for 30 min .
METHODS	In the pseudo-EA group , the pseudo-points lateral to Tianshu ( ST 25 ) , Fujie ( SP 14 ) and Shangjuxu ( ST 37 ) on bilateral sides were punctured shallowly .
METHODS	The electric stimulation was pretended to connect but with the electric wire cutting off .
METHODS	The needles were retained for 30 min .
METHODS	The treatment was given 5 times weekly in the first two weeks and 3 times weekly in the later 6 weeks .
METHODS	Totally , 28 treatments were required .
METHODS	TCM intestine and lung syndrome scale was used for evaluation .
METHODS	The changes in TCM syndromes were observed before and after treatment in the patients of the two groups .
RESULTS	The total score of intestine and lung syndrome and the score of individual syndrome were all reduced after treatment as compared with those before treatment in the two groups ( both P < 0.01 ) .
RESULTS	The improvements of the EA group in the total score of intestine system syndrome , the scores of large .
RESULTS	intestine syndrome and stomach syndrome , the total score of lung system syndrome and the score of lung dysfunction in dispersing and descending syndrome were superior to those of the pseudo-EA group ( P < 0.01 , P < 0.05 ) .
RESULTS	The differences in the scores of lung qi deficiency syndrome and throat syndrome were not significant between the two groups ( all P > 0.05 ) .
RESULTS	Simultaneously , the very strong positive correlation ( P < 0.01 ) and positive linear correlation ( P < 0.01 ) were presented in the total score of intestine and lung syndrome of the two groups .
CONCLUSIONS	EA obviously improves in intestine system syndrome ( including large intestine syndrome and stomach syndrome ) , as well as lung system syndrome ( lung dysfunction in dispersing and descending ) in the treatment of constipation .
CONCLUSIONS	But the improvements are not apparent in the treatment of lung qi deficiency and throat disorder .
CONCLUSIONS	Additionally , the obvious correlation is displayed in the improvements in intestine and lung syndrome .

###25588168
OBJECTIVE	The purpose of this study was to analyze the removal of implant-supported crowns retained by three different cements using an air-accelerated crown remover and to evaluate the patients ' response to the procedure .
METHODS	This controlled clinical trial was conducted with 21 patients ( 10 women , 11 men ; mean age : 51 10.2 years ) who had received a total of 74 implants ( all placed in the posterior zone of the mandible ) .
METHODS	Four months after implant surgery , the crowns were cemented on standard titanium abutments of different heights .
METHODS	Three different cements ( two temporary : Harvard TEMP and Improv ; and one definitive : Durelon ) were used and randomly assigned to the patients .
METHODS	Eight months later , one blinded investigator removed all crowns .
METHODS	The number of activations of the instrument ( CORONAflex , KaVo ) required for crown removal was recorded .
METHODS	The patients completed a questionnaire retrospectively to determine the impact of the procedure and to gauge their subjective perception .
METHODS	A linear regression model and descriptive statistics were used for data analysis .
RESULTS	All crowns could be retrieved without any technical complications or damage .
RESULTS	Both abutment height ( P = .019 ) and cement type ( P = .004 ) had a significant effect on the number of activations , but the type of cement was more important .
RESULTS	An increased total number of activations had no or only a weak correlation to the patients ' perception of concussion , noise , pain , and unwillingness to use the device .
CONCLUSIONS	Cemented implant crowns can be removed , and the application of an air-accelerated device is a practicable method .
CONCLUSIONS	A type of cement with appropriate retention force has to be selected .
CONCLUSIONS	The impact on the patients ' subjective perception should be taken into account .

###25301859
OBJECTIVE	Women with severe aortic valve stenosis ( AS ) have better LV systolic function and more concentric LV geometry than their male counterparts .
OBJECTIVE	However , sex differences in cardiovascular ( CV ) outcome during progression of AS have not been reported from a longitudinal prospective study .
METHODS	Doppler echocardiography and CV events were recorded during a median of 4.0 years in 979 men and 632 women aged 28-86 ( mean 6710 ) years in the Simvastatin Ezetimibe in Aortic Stenosis ( SEAS ) study .
METHODS	LV systolic function was assessed by EF and midwall shortening ( MWS ) .
METHODS	Study outcomes were AS-related events , ischaemic CV events and total mortality .
RESULTS	The annular cumulative incidence of AS events , ischaemic CV events and death was 8.1 % , 3.4 % and 2.8 % in women , and 8.9 % , 4.4 % and 2.4 % in men , respectively .
RESULTS	Women and men had similar AS progression rate whether measured by peak jet velocity , mean gradient or valve area .
RESULTS	In multivariate analyses , female sex independently predicted less reduction in LV MWS and EF during follow-up ( both p < 0.05 ) .
RESULTS	In time-varying Cox analyses , women had a 40 % lower rate of ischaemic CV events ( 95 % CI 21 % to 54 % ) , in particular , more than 50 % lower rate of stroke and coronary artery bypass grafting , and a 31 % lower all-cause mortality ( 95 % CI 1 % to 51 % ) , independent of active study treatment , age and hypertension , as well as time-varying valve area , low systolic function and abnormal LV geometry .
RESULTS	AS event rate did not differ by sex .
CONCLUSIONS	In the SEAS study , women and men had similar rates of AS progression and AS-related events .
CONCLUSIONS	However , women had lower total mortality and ischaemic CV event rate than men independent of confounders .
BACKGROUND	ClinicalTrials.gov identifier : NCT00092677 .

###24589242
OBJECTIVE	The purpose of the present study was to compare the effect of oral bromelain ( 4 250 mg ) versus oral diclofenac sodium ( 4 25 mg ) on pain , swelling , trismus , and quality of life ( QOL ) after surgical removal of impacted lower third molars .
METHODS	A randomized , double-blind , placebo-controlled study was planned .
METHODS	The sample included patients requiring extraction under local anesthesia of a single partial bony impacted mandibular third molar .
METHODS	The patients were randomly distributed into 1 of 3 groups : bromelain , diclofenac , and placebo .
METHODS	Treatment started 1 day before surgery and continued for 4 days .
METHODS	The predictor variable was the type of the drug given to the patients .
METHODS	The outcome variables were pain , swelling , and trismus , which were measured at 1 , 3 , and 7 days postoperatively .
METHODS	The other study variables included QOL measures to assess the patients ' perception regarding the effect of surgery on their well-being and daily activities .
METHODS	A validated questionnaire was used to measure QOL .
METHODS	The data were analyzed using analysis of variance , multiple measures analysis of variance , or Pearson 's ( 2 ) test , as appropriate .
METHODS	P < .05 was considered significant .
RESULTS	A total of 45 subjects requiring surgical removal of a single impacted mandibular third molar under local anesthesia were included in the present study .
RESULTS	The bromelain and diclofenac groups both showed a significant reduction in pain compared with the placebo group at all intervals ( P < .05 ) .
RESULTS	Diclofenac also resulted in a significant reduction of swelling at 3 and 7 days , and bromelain resulted in an insignificant reduction .
RESULTS	A nonsignificant reduction in trismus occurred in both treatment groups compared with the placebo group .
RESULTS	Both treatment groups also showed a significant difference in the effect on QOL in most subscales and total scores ( P < .05 ) .
RESULTS	The effect was comparable between the 2 treatment groups for all parameters and at all intervals .
CONCLUSIONS	The results of our study have shown that oral bromelain is an effective therapy to improve the QOL after surgical removal of impacted lower third molars , with an effect on the postoperative sequelae comparable to that of preemptive diclofenac sodium .

###25240692
OBJECTIVE	Little is known about the effect of various dietary fatty acids on pro- and anti-inflammatory processes .
OBJECTIVE	We investigated the effect of 5 oils containing various amounts of alpha-linolenic acid ( ALA ) , linoleic acid ( LA ) , oleic acid ( OA ) and docosahexaenoic acid ( DHA ) on plasma inflammatory biomarkers and expression levels of key inflammatory genes and transcription factors in whole blood cells .
RESULTS	In a randomized , crossover controlled nutrition intervention , 114 adult men and women with abdominal obesity and at least one other criterion for the metabolic syndrome consumed 5 experimental isoenergetic diets for 4 weeks each , separated by 4-week washout periods .
RESULTS	Each diet provided 60 g/3000 kcal of different oils : 1 ) control corn/safflower oil blend ( CornSaff ; LA-rich ) , 2 ) flax/safflower oil blend ( FlaxSaff ; ALA-rich ) , 3 ) conventional canola oil ( Canola ; OA-rich ) , 4 ) high oleic canola oil ( CanolaOleic ; highest OA content ) , 5 ) DHA-enriched high oleic canola oil ( CanolaDHA ; OA - and DHA-rich ) .
RESULTS	Gene expression in whole blood cells was assessed in a subset of 62 subjects .
RESULTS	CanolaDHA increased plasma adiponectin concentrations compared with the control CornSaff oil treatment ( +4.5 % , P = 0.04 ) and FlaxSaff ( +6.9 % , P = 0.0008 ) .
RESULTS	CanolaDHA also reduced relative expression levels of interleukin ( IL ) 1B compared with CornSaff and Canola ( -11 % and -13 % , respectively , both P = 0.03 ) .
RESULTS	High-sensitivity C-reactive protein concentrations were lower after Canola than after FlaxSaff ( -17.8 % , P = 0.047 ) .
CONCLUSIONS	DHA-enriched canola oil exerts anti-inflammatory effects compared with polyunsaturated fatty acids from plant sources .

###24968645
OBJECTIVE	The present study aimed to compare the treatment outcomes of a fixed-functional appliance ( Twin-Force Bite Corrector - TFBC ) and a conventional removable functional appliance ( Activator ) in the treatment of skeletal Class II malocclusions .
METHODS	The TFBC and Activator Groups each included 10 young adults possessing a skeletal Class II malocclusion , and the treatment outcomes of both groups were quantified and compared , using lateral cephalometric radiographs , with an untreated skeletal Class II Control Group .
RESULTS	A skeletal Class I relationship and a marked reduction in overjet were achieved in both treatment groups ; however , the duration of treatment was significantly shorter in the TFBC Group ( 0.45 years ) when compared with the Activator Group ( 1.37 years ) ( p < 0.001 ) .
RESULTS	Effective length and sagittal positioning of the mandible underwent significant changes in the TFBC and Activator Groups .
RESULTS	Vertical facial dimensions increased in each group ; however , these increases were significantly greater in the Activator Group when compared to the TFBC and Control Groups ( p < 0.05 ) .
RESULTS	Dentoalveolar changes also contributed to the reduction in overjet .
CONCLUSIONS	Although both appliances succeeded in eliminating the Class II relationship and improving the overjet and overbite , the short treatment time in the TFBC Group raises questions regarding the long-term stability of the results .

###25174568
BACKGROUND	NHS Health Checks is a new program for primary prevention of heart disease , stroke , diabetes , chronic kidney disease , and vascular dementia in adults aged 40 to 74years in England .
BACKGROUND	Individuals without existing cardiovascular disease or diabetes are invited for a Health Check every 5years .
BACKGROUND	Uptake among those invited is lower than anticipated .
METHODS	The project is a three-arm randomized controlled trial to test the hypothesis that enhanced invitation methods , using the Question-Behaviour Effect ( QBE ) , will increase uptake of NHS Health Checks compared with a standard invitation .
METHODS	Participants comprise individuals eligible for an NHS Health Check registered in two London boroughs .
METHODS	Participants are randomized into one of three arms .
METHODS	Group A receives the standard NHS Health Check invitation letter , information sheet , and reminder letter at 12weeks for nonattenders .
METHODS	Group B receives a QBE questionnaire 1week before receiving the standard invitation , information sheet , and reminder letter where appropriate .
METHODS	Group C is the same as Group B , but participants are offered a 5 retail voucher if they return the questionnaire .
METHODS	Participants are randomized in equal proportions , stratified by general practice .
METHODS	The primary outcome is uptake of NHS Health Checks 6months after invitation from electronic health records .
METHODS	We will estimate the incremental health service cost per additional completed Health Check for trial groups B and C versus trial arm A , as well as evaluating the impact of the QBE questionnaire , and questionnaire plus voucher , on the socioeconomic inequality in uptake of Health Checks.The trial includes a nested comparison of two methods for implementing allocation , one implemented manually at general practices and the other implemented automatically through the information systems used to generate invitations for the Health Check .
CONCLUSIONS	The research will provide evidence on whether asking individuals to complete a preliminary questionnaire , by using the QBE , is effective in increasing uptake of Health Checks and whether an incentive alters questionnaire return rates as well as uptake of Health Checks .
CONCLUSIONS	The trial interventions can be readily translated into routine service delivery if they are shown to be cost-effective .
BACKGROUND	Current Controlled Trials ISRCTN42856343 .
BACKGROUND	Date registered : 21.03.2013 .

###25335245
OBJECTIVE	To compare the difference in the clinical efficacy on posterior circulation ischemia between acupuncture at stellate ganglion and conventional acupuncture as well as the impacts on blood pressure .
METHODS	Eighty cases of posterior circulation ischemia were randomized into an observation group ( 40 cases ) and a control group ( 40 cases ) .
METHODS	In the observation group , acupuncture was applied to the bilateral stellate ganglions on the neck , stimulated with reinforcing technique by rotating the needles .
METHODS	In the control group , the acupuncture of reducing technique was applied to Fengchi ( GB 20 ) , Baihui ( GV 20 ) , Neiguan ( PC 6 ) and Taichong ( LR 3 ) in the excess syndrome .
METHODS	The even needling or reinforcing technique was applied to Fengchi ( GB 20 ) , Baihui ( GV 20 ) , Ganshu ( BL 18 ) , Shenshu ( BL 23 ) and Zusanli ( ST 36 ) for the deficiency syndrome .
METHODS	The treatment was given once every 3 days and 4 treatments were required totally in the two groups .
METHODS	The changes in total syndrome score , peak Systolic blood flow velocity ( Vp ) of vertebral artery and basilar artery , systolic and diastolic blood pressures were compared before and after treatment in the two groups .
METHODS	The clinical efficacy was compared between the two groups .
RESULTS	The total syndrome score was reduced apparently after treatment compared with that before treatment in the two groups ( P < 0.01 ) , and the reducing was more obvious in the observation group as compared with that in the control group ( P < 0.01 ) .
RESULTS	The total effective rate was 87.5 % ( 35/40 ) in the observation group , higher than 67.5 % ( 27/40 , P < 0.05 ) in the control group .
RESULTS	After treatment , the reduced Vp of vertebral artery was not improved apparently as compared with that before treatment in the control group , Vp in blood velocity abnormality ( including vascular spasm , stenosis or reduced velocity ) of vertebral artery and basilar artery was all improved as compared with that before treatment in the two groups ( P < 0.01 ) , and the improvements in the observation group were more obvious than those in the control group ( P < 0.01 ) .
RESULTS	After treatment , the systolic and diastolic pressures were reduced as compared with those before treatment in the two groups , and the reduced systolic and diastolic pressures in the observation group were more apparent than those in the control group ( P < 0.01 ) .
CONCLUSIONS	Acupuncture at stellate ganglion achieves the satisfactory efficacy in the treatment of posterior circulation ischemia and the significant efficacy of reducing blood pressure , more advanced than the conventional acupuncture .

###24332192
OBJECTIVE	To compare self-reported physical activity recorded in physical activity diaries or the Active Australia Survey with objectively measured physical activity using accelerometry in sedentary middle-aged adults completing two physical activity interventions .
METHODS	Cross-sectional study .
METHODS	Sedentary 50-65 year olds were recruited to a non-randomized 6-month community group exercise program ( G ) or a physiotherapist-led home-based physical activity program ( HB ) .
METHODS	Over 7-days , 76 participants ( HB 39 , G 37 ) wore an ActiGraph GT1M accelerometer ( 5s epochs ) , completed the Active Australia Survey ( AAS ) and a daily physical activity diary .
METHODS	Data were analysed using descriptive statistics and Spearman rank-order correlations .
RESULTS	The two interventions had similar demographic and physical activity characteristics except that home-based participants were younger ( p < 0.01 ) , more likely to be employed full time ( p 0.001 ) and reported less moderate-to-vigorous physical activity in the physical activity diaries compared to group exercise participants ( HB 29 21 min d ( -1 ) vs. G 57 35 min d ( -1 ) , p 0.001 ) .
RESULTS	Home-based participants had fair-to-good agreement between the physical activity diaries and AAS or ActiGraph data ( r = 0.39-0 .68 , p < 0.05 ) .
RESULTS	Group exercise physical activity diary data did not correlate significantly with either the AAS or ActiGraph data .
RESULTS	In contrast , group exercise AAS data had good correlations with ActiGraph data ( r = 0.49-0 .64 , p 0.001 ) .
CONCLUSIONS	Physical activity diaries should be interpreted cautiously unless intervention participants have an adequate understanding of physical activity intensity .
CONCLUSIONS	The AAS is the preferred self-report measure in middle-aged adults independent of intervention .

###25291577
OBJECTIVE	Human infections with avian influenza A/H7N9 have resulted in high morbidity and mortality in China .
OBJECTIVE	To compare safety and immunogenicity of different doses of influenza A/Shanghai/2 / 13 ( H7N9 ) vaccine mixed with or without the MF59 adjuvant .
METHODS	Multicenter , randomized , double-blind , phase 2 trial at 4 US sites enrolled 700 adults aged 19 to 64 years beginning in September 2013 ; 6-month follow-up was completed in May 2014 .
METHODS	The H7N9 inactivated virus vaccine was administered intramuscularly on days 0 and 21 at nominal doses of 3.75 , 7.5 , 15 , or 45 g of hemagglutinin ( actual doses approximately 50 % higher ) with or without the MF59 adjuvant .
METHODS	A total 99 , 100 , or 101 participants were randomized to each group ( 7 groups ; N = 700 ) .
METHODS	Proportions achieving day 42 antibody titer of 40 or greater or seroconversion ( a minimum 4-fold increase to titer 40 ) with the hemagglutination inhibition assay ; vaccine-related serious adverse events through month 13 ; and solicited postvaccination symptoms through day 7 .
RESULTS	Hemagglutination inhibition antibodies were minimal after participants received an unadjuvanted vaccine .
RESULTS	After receiving 2 doses of H7N9 vaccine at a dosage of 3.75 g plus the MF59 adjuvant , day 42 seroconversion occurred in 58 participants ( 59 % ; 95 % CI , 48 % -68 % ) .
RESULTS	The peak seroconversion occurred at day 29 in 62 participants ( 62 % ; 95 % CI , 52 % -72 % ) .
RESULTS	The day 42 geometric mean titer was 33.0 ( 95 % CI , 24.7-44 .1 ) .
RESULTS	Higher antigen doses were not associated with increased response .
RESULTS	For the neutralizing antibody assays , after receiving 3.75 g of H7N9 vaccine plus the MF59 adjuvant , day 42 seroconversion occurred in 81 participants ( 82 % ; 95 % CI , 73 % -89 % ) .
RESULTS	The day 42 geometric mean titer was 81.4 ( 95 % CI , 66.6-99 .5 ) .
RESULTS	There was no statistically significant difference in day 42 hemagglutination inhibition seroconversion after mixing adjuvant with either the first or both 15 g doses ( n = 34 [ 35 % ; 95 % CI , 25 % -45 % ] vs n = 47 [ 47 % ; 95 % CI , 37 % -58 % ] , respectively ; P = .10 ) .
RESULTS	Recent receipt of seasonal influenza vaccination and older age were associated with attenuated response .
RESULTS	No vaccine-related serious adverse events occurred .
RESULTS	Solicited postvaccination symptoms were generally mild with more local symptoms seen in participants who received the adjuvant .
CONCLUSIONS	Point-of-use mixing and administration of 2 doses of H7N9 vaccine at the lowest tested antigen dose with MF59 adjuvant produced seroconversion in 59 % of participants .
CONCLUSIONS	Although these findings indicate potential value in this approach , the study is limited by the absence of antibody data beyond 42 days and the absence of clinical outcomes .
BACKGROUND	clinicaltrials.gov Identifier : NCT01938742 .

###24812023
BACKGROUND	Previous exercise intervention studies for smoking cessation have been challenged by a number of methodological limitations that confound the potential efficacy of aerobic exercise for smoking cessation .
METHODS	The preliminary efficacy of a behavioral exercise intervention that incorporated features designed to address prior limitations was tested in a randomized controlled trial ( RCT ) .
METHODS	Sixty-one smokers ( 65.6 % female , mean age = 47.3 years , smoked a mean of 19.7 cigarettes/day ) were randomized to receive either a 12-week exercise intervention or a 12-week health education contact control .
METHODS	Participants in both conditions received an 8-week telephone-delivered , standard smoking cessation protocol ( with the transdermal nicotine patch ) .
METHODS	Follow-ups were conducted at the end of treatment ( EOT ) , 6 - and 12-month timepoints .
RESULTS	There were no differences between conditions with respect to the number of weekly exercise or health education sessions attended ( 9.32.8 vs. 9.33.0 , respectively ) .
RESULTS	While not statistically significant , participants in the exercise condition demonstrated higher verified abstinence rates ( EOT : 40 % vs. 22.6 % , odds ratio [ OR ] = 2.28 ; 6 - and 12-month follow-ups : 26.7 % vs. 12.9 % , OR = 2.46 ) .
RESULTS	Irrespective of treatment condition , higher levels of moderate-to-vigorous exercise were associated with lower levels of depressive symptoms during the intervention .
CONCLUSIONS	The results of this small RCT point toward the benefit of a behavioral exercise intervention designed to address previous methodological limitations for smoking cessation .
CONCLUSIONS	Given the potential public health impact of the demonstrated efficacy of exercise for smoking cessation , the continued development and optimization of exercise interventions for smokers through larger RCTs merits pursuit .

###24933106
OBJECTIVE	Statins are commonly used for the management of dyslipidemia in type 2 diabetes mellitus patients .
OBJECTIVE	We hypothesized that atorvastatin could modulate the beta-cell function by altering the levels of proapoptotic and antiapoptotic lipoproteins and could also have an effect on insulin resistance .
OBJECTIVE	The aim of the present pilot study was to assess the effect of atorvastatin 10 mg on pancreatic beta-cell function and insulin resistance in patients with hyperlipidemia and type 2 diabetes by using the homeostasis model assessment-2 ( HOMA2 ) index .
METHODS	Fifty-one type 2 diabetes patients receiving oral antidiabetes drugs , not taking statins , with baseline low-density lipoprotein cholesterol between 2.6 mmol/L and 4.1 mmol/L were included .
METHODS	Forty-three patients ( 21 in placebo group and 22 in atorvastatin group ) completed the study and were taken up for final analysis .
METHODS	Fasting blood samples were obtained at baseline and at 12 weeks to determine levels of blood glucose , lipid profile , insulin , C-peptide and glycosylated hemoglobin ( A1C ) .
RESULTS	Atorvastatin nonsignificantly increased fasting serum insulin ( +14.29 % , p = 0.18 ) , accompanied by marginal nonsignificant increases in fasting plasma glucose and A1C .
RESULTS	There was a decrease in HOMA2 percent beta-cell function ( -2.9 % , p = 0.72 ) and increase in HOMA2 insulin resistance ( +14 % , p = 0.16 ) in the atorvastatin group as compared with baseline , but the difference was not statistically significant .
CONCLUSIONS	Atorvastatin in the dose used failed to produce significant change in pancreatic beta-cell function and insulin resistance in type 2 diabetes patients as assessed by the HOMA2 index .
CONCLUSIONS	The possible explanations include absence of lipotoxicity at prevailing levels of dyslipidemia at baseline or inadequacy of statin dose used in the study .
CONCLUSIONS	( Clinical Trials Registry-India : CTRI/2008/091 / 000099 ) .

###24990423
BACKGROUND	Critically ill patients typically receive 60 % of estimated calorie requirements .
OBJECTIVE	We aimed to determine whether the substitution of a 1.5-kcal / mL enteral nutrition solution for a 1.0-kcal / mL solution resulted in greater calorie delivery to critically ill patients and establish the feasibility of conducting a multicenter , double-blind , randomized trial to evaluate the effect of an increased calorie delivery on clinical outcomes .
METHODS	A prospective , randomized , double-blind , parallel-group , multicenter study was conducted in 5 Australian intensive care units .
METHODS	One hundred twelve mechanically ventilated patients expected to receive enteral nutrition for 2 d were randomly assigned to receive 1.5 ( n = 57 ) or 1.0 ( n = 55 ) kcal/mL enteral nutrition solution at a rate of 1 mL/kg ideal body weight per hour for 10 d. Protein and fiber contents in the 2 solutions were equivalent .
RESULTS	The 2 groups had similar baseline characteristics ( 1.5 compared with 1.0 kcal/mL ) .
RESULTS	The mean ( SD ) age was 56.4 16.8 compared with 56.5 16.1 y , 74 % compared with 75 % were men , and the Acute Physiology and Chronic Health Evaluation II score was 23 9.1 compared with 22 8.9 .
RESULTS	The groups received similar volumes of enteral nutrition solution [ 1221 mL/d ( 95 % CI : 1120 , 1322 mL/d ) compared with 1259 mL/d ( 95 % CI : 1143 , 1374 mL/d ) ; P = 0.628 ] , which led to a 46 % increase in daily calories in the group given the 1.5-kcal / mL solution [ 1832 kcal/d ( 95 % CI : 1681 , 1984 kcal/d ) compared with 1259 kcal/d ( 95 % CI : 1143 , 1374 kcal/d ) ; P < 0.001 ] .
RESULTS	The 1.5-kcal / mL solution was not associated with larger gastric residual volumes or diarrhea .
RESULTS	In this feasibility study , there was a trend to a reduced 90-d mortality in patients given 1.5 kcal/mL [ 11 patients ( 20 % ) compared with 20 patients ( 37 % ) ; P = 0.057 ] .
CONCLUSIONS	The substitution of a 1.0 - with a 1.5-kcal / mL enteral nutrition solution administered at the same rate resulted in a 46 % greater calorie delivery without adverse effects .
CONCLUSIONS	The results support the conduct of a large-scale trial to evaluate the effect of increased calorie delivery on clinically important outcomes in the critically ill .

###25041486
BACKGROUND	Ilaprazole , a proton pump inhibitor ( PPI ) currently in clinical use , may provide improved acid suppression vs. other PPIs .
OBJECTIVE	To compare the pharmacodynamic and pharmacokinetic profiles of ilaprazole and esomeprazole .
METHODS	A phase 1 , randomised , open-label , single-centre , 4-period crossover study was conducted in 40 healthy volunteers .
METHODS	Ilaprazole 10 , 20 or 40mg or esomeprazole 40mg was administered once daily for 5days with 5-day washout intervals .
METHODS	Pharmacokinetic blood samples and intragastric pH measurements were collected at scheduled timepoints for 24h after dosing on Days 1 and 5 .
RESULTS	Esomeprazole 40mg provided significantly better pH control during the initial hours ( 0-4h ) after a single dose , but ilaprazole ( particularly 20 and 40mg ) provided significantly better pH control for the entire 24-h period and during evening and overnight hours after single and multiple doses .
RESULTS	Increasing ilaprazole doses resulted in dose-proportional increases in peak plasma concentration and area under the plasma concentration vs. time curve following single and multiple doses .
RESULTS	Ilaprazole was safe and generally well tolerated ; an unexpectedly high incidence of allergic eye and skin reactions were observed but were not specific to any dosing regimen .
RESULTS	Plasma gastrin concentrations did not increase proportionately with increasing ilaprazole dose .
CONCLUSIONS	Ilaprazole provided significantly better pH control over 24h and during evening and overnight hours compared with esomeprazole in healthy volunteers , which may translate to greater relief of night-time heartburn in the clinical setting for patients with gastric acid-related disorders .

###24903985
OBJECTIVE	The aim of this study was to evaluate whether the remote introduction of electronic decision support tools into family practices improves risk factor control after first stroke .
OBJECTIVE	This study also aimed to develop methods to implement cluster randomized trials in stroke using electronic health records .
METHODS	Family practices were recruited from the UK Clinical Practice Research Datalink and allocated to intervention and control trial arms by minimization .
METHODS	Remotely installed , electronic decision support tools promoted intensified secondary prevention for 12 months with last measure of systolic blood pressure as the primary outcome .
METHODS	Outcome data from electronic health records were analyzed using marginal models .
RESULTS	There were 106 Clinical Practice Research Datalink family practices allocated ( intervention , 53 ; control , 53 ) , with 11 391 ( control , 5516 ; intervention , 5875 ) participants with acute stroke ever diagnosed .
RESULTS	Participants at trial practices had similar characteristics as 47,887 patients with stroke at nontrial practices .
RESULTS	During the intervention period , blood pressure values were recorded in the electronic health records for 90 % and cholesterol values for 84 % of participants .
RESULTS	After intervention , the latest mean systolic blood pressure was 131.7 ( SD , 16.8 ) mm Hg in the control trial arm and 131.4 ( 16.7 ) mm Hg in the intervention trial arm , and adjusted mean difference was -0.56 mm Hg ( 95 % confidence interval , -1.38 to 0.26 ; P = 0.183 ) .
RESULTS	The financial cost of the trial was approximately US $ 22 per participant , or US $ 2400 per family practice allocated .
CONCLUSIONS	Large pragmatic intervention studies may be implemented at low cost by using electronic health records .
CONCLUSIONS	The intervention used in this trial was not found to be effective , and further research is needed to develop more effective intervention strategies .
BACKGROUND	http://www.controlled-trials.com .
BACKGROUND	Current Controlled Trials identifier : ISRCTN35701810 .

###25038914
BACKGROUND	Introducing colonoscopy as part of colorectal cancer screening on a national level , we aimed at evaluating the efficacy of the two most common bowel cleansing agents , Moviprep ( ) and Phosphoral ( ) .
BACKGROUND	Secondly , we evaluated the benefit for the patient and society in terms of sick leave and discomfort .
METHODS	In a single-blinded randomized equivalence trial , Phosphoral ( ) ( NaP ) was compared with Moviprep ( ) ( 2 l polyethylene glycol + ascorbic acid ) in patients undergoing colonoscopy due to suspicion of cancer .
METHODS	Patients filled out questionnaires concerning stool consistency , discomfort and number of sick days due to bowel cleansing .
METHODS	Blinded colonoscopists estimated the efficiency of the cleansing using the validated Harefield Cleansing Scale .
RESULTS	Two hundred and sixty-six patients were included 250 of whom underwent full colonoscopy .
RESULTS	There was no difference in the percentage of acceptable bowel cleansings in the two groups ; however , a significantly higher number of A scores were observed in the Moviprep ( ) group ( p = 0.028 ) .
RESULTS	We found no correlation between stool consistency and outcome of the cleansing and no difference in subjective discomfort during cleansing .
RESULTS	Vomiting during cleansing occurred more often in the Phosphoral ( ) group ( p = 0.002 ) .
RESULTS	There was a trend toward a smaller number of sick days in patients who used Moviprep ( ) compared with Phosphoral ( ) .
CONCLUSIONS	Moviprep ( ) and Phosphoral ( ) provided equally efficient bowel cleansing in 90 % of patients , but Moviprep ( ) provided a higher quality of cleansings graded as successful .
CONCLUSIONS	The two agents were equally tolerated , and no difference was found in the related number of sick days .

###25387780
BACKGROUND	Improving health-related quality of life ( HRQoL ) is an important treatment goal in the management of patients with atrial fibrillation ( AF ) .
BACKGROUND	Uncertainty exists as to whether patients ' HRQoL differ when treated with medical rhythm control or rate control .
BACKGROUND	We compared HRQoL between patients treated with rhythm control or rate control in a large observational registry of patients with recent-onset AF .
RESULTS	In the Registry on Cardiac Rhythm Disorders Assessing the Control of Atrial Fibrillation ( RECORD-AF ) , 2439 patients with recent onset ( < 1 year ) AF completed an AF-specific HRQoL questionnaire , the University of Toronto Atrial Fibrillation Severity Scale .
RESULTS	HRQoL was assessed by the AF symptom severity score ( 0-35 , with higher scores reflecting more severe AF-related symptoms ) at baseline and 1 year .
RESULTS	The minimal clinically important difference was defined as a change of 3 points .
RESULTS	The primary analysis was based on a propensity score-adjusted longitudinal regression analysis which compared the change in AF symptom severity scores between the 2 groups .
RESULTS	Over an average follow-up of 1 year , the AF symptom severity scores improved in both groups ( rhythm control : -2.82 point [ 95 % confidence interval , -3.22 to -2.41 ] ; rate control : -2.11 point [ 95 % confidence interval , -2.54 to -1.67 ] ; P < 0.01 for both groups ) .
RESULTS	The magnitude of improvement was higher in the rhythm control group than the rate control group ( unadjusted difference : -0.75 point ; 95 % confidence interval , -1.31 to -0.19 ; P = 0.01 ; propensity score-adjusted difference : -0.71 point ; 95 % confidence interval , -1.31 to -0.11 ; P = 0.02 ) .
CONCLUSIONS	In this observational cohort of recent-onset AF patients , treatment with medical rhythm - or rate control over 1 year was associated with an improvement in HRQoL .
CONCLUSIONS	The magnitude of HRQoL improvement was minimally higher in patients treated with rhythm control than rate control .
CONCLUSIONS	However , the overall degree of improvement was not large , and its clinical significance was uncertain .

###25375780
OBJECTIVE	To compare outcomes after 6-month maintenance treatment of adults diagnosed with obsessive-compulsive disorder ( OCD ) based on DSM-IV criteria who responded to acute treatment with serotonin reuptake inhibitors ( SRIs ) augmented by exposure and response prevention ( EX/RP ) or risperidone .
METHODS	A randomized trial was conducted at 2 academic sites from January 2007 through December 2012 .
METHODS	In the acute phase , 100 patients on therapeutic SRI dose with at least moderate OCD severity were randomized to 8 weeks of EX/RP , risperidone , or pill placebo .
METHODS	Responders entered the 6-month maintenance phase , continuing the augmentation strategy they received acutely ( n = 30 EX/RP , n = 8 risperidone ) .
METHODS	Independent evaluations were conducted every month .
METHODS	The main outcome was the Yale-Brown Obsessive Compulsive Scale ( Y-BOCS ) .
RESULTS	Intent-to-treat analyses indicated that , after 6-month maintenance treatment , EX/RP yielded OCD outcomes that were superior to risperidone ( Y-BOCS = 10.95 vs 18.70 ; t40 = 2.76 , P = .009 ) ; more patients randomized to EX/RP met response criteria ( Y-BOCS decrease 25 % : 70 % vs 20 % ; P < .001 ) and achieved minimal symptoms ( Y-BOCS 12 : 50 % vs 5 % ; P < .001 ) .
RESULTS	During maintenance , OCD severity decreased slightly in both conditions ( Y-BOCS decrease = 2.2 points , P = .020 ) .
RESULTS	Lower Y-BOCS at entry to maintenance was associated with more improvement in both conditions ( r38 = 0.57 , P < .001 ) .
CONCLUSIONS	OCD patients taking SRIs who responded to acute EX/RP or risperidone maintained their gains over 6-month maintenance .
CONCLUSIONS	Because EX/RP patients improved more during acute treatment than risperidone-treated patients , and both maintained their gains during maintenance , EX/RP yielded superior outcomes 6 months later .
CONCLUSIONS	The findings that 50 % of patients randomized to EX/RP had minimal symptoms at 6-month maintenance , a rate double that of prior studies , suggests that EX/RP maintenance helps maximize long-term outcome .
BACKGROUND	ClinicalTrials.gov identifier : NCT00389493 .

###24354731
OBJECTIVE	Examine women 's perceptions of what is ` normal ' and ` desirable ' in female genital appearance .
METHODS	Experiment with random allocation across three conditions .
METHODS	Community .
METHODS	A total of 97 women aged 18-30years .
METHODS	Women were randomly assigned to view a series of images of ( 1 ) surgically modified vulvas or ( 2 ) nonmodified vulvas , or ( 3 ) no images .
METHODS	They then viewed and rated ten target images of surgically modified vulvas and ten of unmodified vulvas .
METHODS	Women used a four-point Likert scale ( ` strongly agree ' to ` strongly disagree ' ) , to rate each target image for ` looks normal ' and ` represents society 's ideal ' .
METHODS	For each woman , we created two summary scores that represented the extent to which she rated the unmodified vulvas as more ` normal ' and more ` society 's ideal ' than the modified vulvas .
RESULTS	For ratings of ` normality , ' there was a significant effect for condition ( F2 ,94 = 2.75 P = 0.007 , radj2 = 0.082 ) : women who had first viewed the modified images rated the modified target vulvas as more normal than the nonmodified vulvas , significantly different from the control group , who rated them as less normal .
RESULTS	For ratings of ` society 's ideal ' , there was again a significant effect for condition ( F2 ,92 = 7.72 , P < 0.001 , radj2 = 0.125 ) ; all three groups rated modified target vulvas as more like society 's ideal than the nonmodified target vulvas , with the effect significantly strongest for the women who had viewed the modified images .
CONCLUSIONS	Exposure to images of modified vulvas may change women 's perceptions of what is normal and desirable .
CONCLUSIONS	This may explain why some healthy women seek labiaplasty .

###25027139
OBJECTIVE	Chronic musculoskeletal pain is among the most prevalent , costly , and disabling medical disorders .
OBJECTIVE	However , few clinical trials have examined interventions to improve chronic pain in primary care .
OBJECTIVE	To determine the effectiveness of a telecare intervention for chronic pain .
METHODS	The Stepped Care to Optimize Pain Care Effectiveness ( SCOPE ) study was a randomized trial comparing a telephone-delivered collaborative care management intervention vs usual care in 250 patients with chronic ( 3 months ) musculoskeletal pain of at least moderate intensity ( Brief Pain Inventory [ BPI ] score 5 ) .
METHODS	Patients were enrolled from 5 primary care clinics in a single Veterans Affairs medical center from June 2010 through May 2012 , with 12-month follow-up completed by June 2013 .
METHODS	Patients were randomized either to an intervention group ( n = 124 ) or to a usual care group whose members received all pain care as usual from their primary care physicians ( n = 126 ) .
METHODS	The intervention group received 12 months of telecare management that coupled automated symptom monitoring with an algorithm-guided stepped care approach to optimizing analgesics .
METHODS	Primary outcome was the BPI total score , which ranges from 0 ( `` no pain '' ) to 10 ( `` pain as bad as you can imagine '' ) and for which a 1-point change is considered clinically important .
METHODS	Secondary pain outcomes included BPI interference and severity , global pain improvement , treatment satisfaction , and use of opioids and other analgesics .
RESULTS	Overall , mean ( SD ) baseline BPI scores in the intervention and control groups were 5.31 ( 1.81 ) and 5.12 ( 1.80 ) , respectively .
RESULTS	Compared with usual care , the intervention group had a 1.02-point lower ( 95 % CI , -1.58 to -0.47 ) BPI score at 12 months ( 3.57 vs 4.59 ) .
RESULTS	Patients in the intervention group were nearly twice as likely to report at least a 30 % improvement in their pain score by 12 months ( 51.7 % vs 27.1 % ; relative risk , 1.9 [ 95 % CI , 1.4 to 2.7 ] ) , with a number needed to treat of 4.1 ( 95 % CI , 3.0 to 6.4 ) for a 30 % improvement .
RESULTS	Secondary pain outcomes also improved .
RESULTS	Few patients in either group required opioid initiation or dose escalation .
CONCLUSIONS	Telecare collaborative management increased the proportion of primary care patients with improved chronic musculoskeletal pain .
CONCLUSIONS	This was accomplished by optimizing nonopioid analgesic medications using a stepped care algorithm and monitoring .
BACKGROUND	clinicaltrials.gov Identifier : NCT00926588 .

###24263045
OBJECTIVE	Regional anesthesia is a commonly used technique in orthopedic procedures .
OBJECTIVE	Sedation should reduce the patient 's anxiety and fear while increasing regional anesthesia quality .
OBJECTIVE	This study evaluated the hemodynamic changes , level of sedation , both patients ' and surgeons ' levels of satisfaction and potential side effects in patient-controlled sedation using propofol .
METHODS	This randomized clinical trial studied sixty ASA physical class I-III patients scheduled for total knee replacement surgery under combined spinal-epidural anesthesia .
METHODS	Patients in Group P ( n = 30 ) received propofol via a patient-controlled analgesia device with the following settings : intravenous propofol bolus dose 400 g.kg ( -1 ) , 5-minute lockout interval and no basal infusion .
METHODS	In Group S , we infused saline 150 using the same settings .
METHODS	To determine the level of sedation , we used BIS and Observer 's Assessment of Alertness / Sedation Scale .
METHODS	For all patients , we recorded the number of requests .
METHODS	As the fi nal evaluation , we scored surgeons ' and patients ' satisfaction on 4-point scales .
RESULTS	Both BIS values and OAA/S scores were lower in Group P than in Group S. Patients ' satisfaction was higher in Group P , although there was no significant difference with respect to surgeons ' satisfaction between the groups .
RESULTS	The number of requests for sedation was significantly higher in Group S. However , most requests were considered unsuccessful .
CONCLUSIONS	This study suggests that patient-controlled sedation with propofol can be used efficiently in orthopedic procedures .

###24927299
BACKGROUND	The high number of adult males engaging in low levels of physical activity and poor dietary practices , and the health risks posed by these behaviors , necessitate broad-reaching intervention strategies .
BACKGROUND	Information technology ( IT ) - based ( Web and mobile phone ) interventions can be accessed by large numbers of people , yet there are few reported IT-based interventions targeting males ' physical activity and dietary practices .
OBJECTIVE	This study examines the effectiveness of a 9-month IT-based intervention ( ManUp ) to improve the physical activity , dietary behaviors , and health literacy in middle-aged males compared to a print-based intervention .
METHODS	Participants , recruited offline ( eg , newspaper ads ) , were randomized into either an IT-based or print-based intervention arm on a 2:1 basis in favor of the fully automated IT-based arm .
METHODS	Participants were adult males aged 35-54 years living in 2 regional cities in Queensland , Australia , who could access the Internet , owned a mobile phone , and were able to increase their activity level .
METHODS	The intervention , ManUp , was based on social cognitive and self-regulation theories and specifically designed to target males .
METHODS	Educational materials were provided and self-monitoring of physical activity and nutrition behaviors was promoted .
METHODS	Intervention content was the same in both intervention arms ; only the delivery mode differed .
METHODS	Content could be accessed throughout the 9-month study period .
METHODS	Participants ' physical activity , dietary behaviors , and health literacy were measured using online surveys at baseline , 3 months , and 9 months .
RESULTS	A total of 301 participants completed baseline assessments , 205 in the IT-based arm and 96 in the print-based arm .
RESULTS	A total of 124 participants completed all 3 assessments .
RESULTS	There were no significant between-group differences in physical activity and dietary behaviors ( P. 05 ) .
RESULTS	Participants reported an increased number of minutes and sessions of physical activity at 3 months ( exp ( ) = 1.45 , 95 % CI 1.09-1 .95 ; exp ( ) = 1.61 , 95 % CI 1.17-2 .22 ) and 9 months ( exp ( ) = 1.55 , 95 % CI 1.14-2 .10 ; exp ( ) = 1.51 , 95 % CI 1.15-2 .00 ) .
RESULTS	Overall dietary behaviors improved at 3 months ( exp ( ) = 1.07 , 95 % CI 1.03-1 .11 ) and 9 months ( exp ( ) = 1.10 , 95 % CI 1.05-1 .13 ) .
RESULTS	The proportion of participants in both groups eating higher-fiber bread and low-fat milk increased at 3 months ( exp ( ) = 2.25 , 95 % CI 1.29-3 .92 ; exp ( ) = 1.65 , 95 % CI 1.07-2 .55 ) .
RESULTS	Participants in the IT-based arm were less likely to report that 30 minutes of physical activity per day improves health ( exp ( ) = 0.48 , 95 % CI 0.26-0 .90 ) and more likely to report that vigorous intensity physical activity 3 times per week is essential ( exp ( ) = 1.70 , 95 % CI 1.02-2 .82 ) .
RESULTS	The average number of log-ins to the IT platform at 3 and 9 months was 6.99 ( SE 0.86 ) and 9.22 ( SE 1.47 ) , respectively .
RESULTS	The average number of self-monitoring entries at 3 and 9 months was 16.69 ( SE 2.38 ) and 22.51 ( SE 3.79 ) , respectively .
CONCLUSIONS	The ManUp intervention was effective in improving physical activity and dietary behaviors in middle-aged males with no significant differences between IT - and print-based delivery modes .
BACKGROUND	Australian New Zealand Clinical Trials Registry : ACTRN12611000081910 ; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12611000081910 ( Archived by WebCite at http://www.webcitation.org/6QHIWad63 ) .

###24881898
OBJECTIVE	To determine if there was a difference between patients participating in research and those who did not regarding their satisfaction with the medical encounter and their physician .
METHODS	We prospectively randomized 128 patients to either complete 20 minutes of questionnaires ( participate in research ) or not .
METHODS	After the visit , all patients rated their satisfaction with their visit and satisfaction with the doctor on an 11-point ordinal satisfaction scales , with 0 being not at all satisfied and 10 being completely satisfied .
METHODS	Average satisfaction scores were analyzed in relation to demographics , questionnaires , and involvement in research .
RESULTS	There were no significant differences between patients that did and did not participate in research for satisfaction with the medical encounter or satisfaction with the treating physician .
RESULTS	Satisfaction was not associated with marital status , work status , or diagnosis .
RESULTS	There was a significant correlation between greater satisfaction and both less education and lower self-efficacy .
RESULTS	There was no significant correlation between patient satisfaction and magnitude of disability , pain intensity , or health anxiety .
CONCLUSIONS	This study demonstrated that patients ' participation in research can coexist with patient satisfaction .
METHODS	Prognostic I.

###24312709
OBJECTIVE	A dietary regimen consisting of a clear liquid diet ( CLD ) for at least 24 hours is recommended for colonoscopy preparation .
OBJECTIVE	However , this requirement results in problems in patient compliance with bowel preparation .
OBJECTIVE	The aim of this study was to evaluate the efficacy of a CLD compared with a regular diet ( RD ) for colonoscopy preparation using a polyethylene glycol ( PEG ) solution .
METHODS	This was a multicenter , randomized , investigator-blind prospective study .
METHODS	A total of 801 healthy outpatients undergoing afternoon colonoscopy were randomized to either a CLD or RD in addition to a 4 L PEG regimen .
RESULTS	The quality of bowel cleansing was not different between the CLD and RD groups in terms of the proportion with excellent or good preparation .
RESULTS	In addition , no significant differences were observed between the two groups for polyp and adenoma detection rates and overall adverse events .
RESULTS	Good compliance with bowel preparation was higher in the RD group than in the CLD group .
CONCLUSIONS	A CLD for a full day prior to colonoscopy should not be mandatory for PEG-based bowel preparation .
CONCLUSIONS	Dietary education concerning the avoidance of high-fiber foods for 3 days before colonoscopy is sufficient , at least for healthy outpatients .

###25559090
BACKGROUND	Impairments of memory are commonly reported by people with traumatic brain injuries ( TBI ) .
BACKGROUND	Such deficits are persistent , debilitating , and can severely impact quality of life .
BACKGROUND	Currently , many do not routinely receive follow-up appointments for residual memory problems following discharge .
METHODS	This is a multi-centre , randomised controlled trial investigating the clinical and cost-effectiveness of a group-based memory rehabilitation programme .
METHODS	Three hundred and twelve people with a traumatic brain injury will be randomised from four centres .
METHODS	Participants will be eligible if they had a traumatic brain injury more than 3 months prior to recruitment , have memory problems , are 18 to 69 years of age , are able to travel to one of our centres and attend group sessions , and are able to give informed consent .
METHODS	Participants will be randomised in clusters of 4 to 6 to the group rehabilitation intervention or to usual care .
METHODS	Intervention groups will receive 10 weekly sessions of a manualised memory rehabilitation programme , which has been developed in previous pilot studies .
METHODS	The intervention will include restitution strategies to retrain impaired memory functions and compensation strategies to enable participants to cope with their memory problems .
METHODS	All participants will receive a follow-up postal questionnaire and an assessment by a research assistant at 6 and 12 months post-randomisation .
METHODS	The primary outcome is the Everyday Memory Questionnaire at 6 months .
METHODS	Secondary outcomes include the Rivermead Behavioural Memory Test-3 , General Health Questionnaire-30 , health related quality of life , cost-effectiveness analysis determined by the EQ-5D and a service use questionnaire , individual goal attainment , European Brain Injury Questionnaire ( patient and relative versions ) , and the Everyday Memory Questionnaire-relative version .
METHODS	The primary analysis will be based on intention to treat .
METHODS	A mixed-model regression analysis of the Everyday Memory Questionnaire at 6 months will be used to estimate the effect of the group memory rehabilitation programme .
CONCLUSIONS	The study will hopefully provide robust evidence regarding the clinical and cost-effectiveness of a group-based memory rehabilitation intervention for civilians and military personnel following TBI .
CONCLUSIONS	We discuss our decision-making regarding choice of outcome measures and control group , and the unique challenges to recruiting people with memory problems to trials .
BACKGROUND	ISRCTN65792154 ; Date : 18 October 2012 .

###24878943
BACKGROUND	Cardiovascular disease is the major cause of death in hemodialysis patients .
BACKGROUND	Regular aerobic or intradialytic exercise may play a role in reducing cardiovascular mortality in these patients .
BACKGROUND	The aim of this study was to evaluate the relationship between intradialytic exercise and echocardiographic findings .
METHODS	Forty patients were enrolled in the study from Shahrekord Hemodialysis Center .
METHODS	They were randomly assigned into the exercise and control groups .
METHODS	In the exercise group , the patients had a 30-minute exercise program per dialysis session , 3 times a week , for 3 months .
METHODS	Electrocardiography and echocardiography were done at the beginning of the study and 3 months later .
RESULTS	The mean age and body mass index of the patients were 43.2 + / - 10.5 years and 21.7 + / - 5.4 kg/m2 , respectively .
RESULTS	Left ventricular ejection fraction increased and systolic pulmonary artery pressure and right ventricular size decreased significantly after the study in the exercise group patients .
CONCLUSIONS	Our results showed the improvement of cardiac systolic and diastolic function in patients who had physical exercise during dialysis sessions .
CONCLUSIONS	Regular intradialysis exercise can be suggested for hemodialysis patients without cardiac disease .

###24252703
BACKGROUND	Vaccination is an effective strategy to prevent influenza .
BACKGROUND	This observer-blind , randomized study in children 10-17 years of age assessed whether the hemagglutination inhibition ( HI ) antibody responses elicited by H1N1/2009 vaccines adjuvanted with AS03 ( an adjuvant system containing - tocopherol and squalene in an oil-in-water emulsion ) or without adjuvant , met the European regulatory immunogenicity criteria at Days 21 and 182 .
METHODS	Three hundred and ten healthy children were randomized ( 3:3:3:5 ) to receive one dose of 3.75 g hemagglutinin ( HA ) AS03A-adjuvanted vaccine , one or two doses of 1.9 g HA AS03B-adjuvanted vaccine , or one dose of 15 g HA pandemic vaccine .
METHODS	All children received a booster dose of the allocated vaccine at Day 182 .
METHODS	Serum samples were tested for HI antibody response at Days 21 , 42 , 182 and 189 .
RESULTS	All vaccination regimens elicited HI antibody responses that met the European regulatory criteria at Days 21 and 42 .
RESULTS	HI antibody responses fulfilling European regulatory criteria were still observed six months after the first vaccine dose in all study vaccines groups .
RESULTS	Two doses of 1.9 g HA AS03B-adjuvanted vaccine elicited the strongest HI antibody response throughout the study .
RESULTS	The non-adjuvanted 15 g HA vaccine elicited a lower HI antibody response than the AS03-adjuvanted vaccines .
RESULTS	At Day 189 , the European regulatory criteria were met for all vaccines with baseline HI antibody titers as reference .
RESULTS	An anamnestic response for all vaccines was suggested at Day 189 , based on the rapid increase in HI antibody geometric mean titers ( 1.5-2 .5 - fold increase ) .
RESULTS	Injection site reactogenicity was higher following the AS03-adjuvanted vaccines compared with the non-adjuvanted vaccine .
RESULTS	No safety concerns were identified for any study vaccine .
CONCLUSIONS	All study vaccines elicited HI antibody responses that persisted at purported protective levels through six months after vaccination and fulfilled the European regulatory criteria .

###25352508
BACKGROUND	The importance of measuring blood pressure before morning micturition and in the afternoon , while working , is yet to be established in relation to the accuracy of home blood pressure monitoring ( HBPM ) .
OBJECTIVE	To compare two HBPM protocols , considering 24-hour ambulatory blood pressure monitoring ( wakefulness ABPM ) as gold-standard and measurements taken before morning micturition ( BM ) and in the afternoon ( AM ) , for the best diagnosis of systemic arterial hypertension ( SAH ) , and their association with prognostic markers .
METHODS	After undergoing 24-hour wakefulness ABPM , 158 participants ( 84 women ) were randomized for 3 - or 5-day HBPM .
METHODS	Two variations of the 3-day protocol were considered : with measurements taken before morning micturition and in the afternoon ( BM+AM ) ; and with post-morning-micturition and evening measurements ( PM+EM ) .
METHODS	All patients underwent echocardiography ( for left ventricular hypertrophy - LVH ) and urinary albumin measurement ( for microalbuminuria - MAU ) .
RESULTS	Kappa statistic for the diagnosis of SAH between wakefulness-ABPM and standard 3-day HBPM , 3-day HBPM ( BM+AM ) and ( PM+EM ) , and 5-day HBPM were 0.660 , 0.638 , 0.348 and 0.387 , respectively .
RESULTS	The values of sensitivity of ( BM+AM ) versus ( PM+EM ) were 82.6 % 71 % , respectively , and of specificity , 84.8 % 74 % , respectively .
RESULTS	The positive and negative predictive values were 69.1 % 40 % and 92.2 % 91.2 % , respectively .
RESULTS	The comparisons of intraclass correlations for the diagnosis of LVH and MAU between ( BM+AM ) and ( PM+EM ) were 0.782 0.474 and 0.511 0.276 , respectively .
CONCLUSIONS	The 3 day-HBPM protocol including measurements taken before morning micturition and during work in the afternoon showed the best agreement with SAH diagnosis and the best association with prognostic markers .

###24419017
BACKGROUND	Glenohumeral subluxation is the most frequent complication in post stroke hemiplegia and its reduction has been considered an important goal .
BACKGROUND	Though it has been demonstrated that cyclical electrical stimulation of posterior deltoid and supraspinatus muscles can reduce subluxation , the role of biceps has not been given due consideration .
OBJECTIVE	The purpose of this study was to determine whether electrical stimulation to the long head of biceps could more effectively reduce gleno humeral subluxation .
METHODS	24 patients were selected and consecutively assigned to group 1 ( electrical stimulation to supraspinatus & posterior deltoid ) and group II ( electrical stimulation to supraspinatus , posterior deltoid & long head of the biceps ) along with routine physiotherapy and occupational therapy for a period of 5 weeks .
METHODS	All patients were assessed for shoulder subluxation , pain and shoulder active abduction range of motion at the time of recruitment to study and after 5 weeks of therapy .
RESULTS	Both the groups showed significant improvement in parameters measured .
RESULTS	Tukey 's post hoc analysis showed the results were more significant in Group II .
CONCLUSIONS	Electrical stimulation to biceps along with the supraspinatus and posterior deltoid can more effectively reduce shoulder subluxation .

###24725169
OBJECTIVE	To evaluate the efficacy and safety of tamsulosin dose increase to 0.4 mg daily in Asian patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia refractory to tamsulosin 0.2 mg treatment .
METHODS	We carried out a 12-week , single-center , randomized , placebo-controlled trial in 220 patients .
METHODS	Patients treated with 0.2 mg tamsulosin daily without other lower urinary tract symptoms secondary to benign prostatic hyperplasia medication for more than 3months and refractory to this treatment were enrolled .
METHODS	We defined `` refractory '' as an International Prostate Symptom Score of 13 or greater and a maximum flow rate of 15 or under despite medication .
METHODS	Patients with a surgical history related to lower urinary tract symptoms secondary to benign prostatic hyperplasia or a postvoid residual of 150mL or greater were excluded .
METHODS	Eligible patients were randomly assigned to the 0.4 mg group ( two tablets of 0.2 mg tamsulosin once daily ) or the 0.2 mg group ( one tablet of 0.2 mg tamsulosin and one tablet of placebo once daily ) .
METHODS	International Prostate Symptom Score , maximum flow rate , blood pressure , heart rate , and adverse events were compared between the two groups at 4weeks and 12weeks .
RESULTS	A total of 220 patients were enrolled and analyzed .
RESULTS	There were no differences in baseline characteristics between the two groups .
RESULTS	After 12weeks of medication , the International Prostate Symptom Score was not different between the two groups .
RESULTS	However , the improvement in maximum flow rate was greater in the 0.4 mg group than the 0.2 mg group ( 3.00.48 mL/s vs -0.250.30 mL/s , P < 0.01 ) .
RESULTS	The proportion of patients who showed an increase in maximum flow rate of more than 5mL/s was 10.9 % in the 0.2 mg group versus 16.3 % in the 0.4 mg group ( P = 0.209 ) .
RESULTS	There were no significant differences in bother score or postvoid residual between the two groups .
RESULTS	Systolic and diastolic blood pressure , and heart rate were also not different between the two groups .
RESULTS	The incidence of adverse events was 10.9 % in the 0.2 mg group ( dizziness 5.5 % ; abnormal ejaculation 1.8 % ; palpitation 1.8 % ; and headache 1.8 % ) and 9.09 % in the 0.4 mg group ( dizziness 3.6 % ; abnormal ejaculation 1.8 % ; palpitations 1.8 % ; and headache 1.8 % ) .
CONCLUSIONS	Tamsulosin 0.4 mg appears to be a safe treatment regimen for treating lower urinary tract symptoms secondary to benign prostatic hyperplasia in Asian patients who do not respond to 0.2 mg treatment .
CONCLUSIONS	Increasing the dose of tamsulosin results in a significant improvement in maximum flow rate without any increase in cardiovascular complications .

###24917586
OBJECTIVE	Mechanisms for cancer related fatigue suggest that exercise but `` not too much and not too little '' could be effective .
OBJECTIVE	This study aimed to investigate feasibility and estimate the potential effects of a walking exercise program in people with advanced cancer and fatigue .
METHODS	A pilot randomized trial .
METHODS	McGill University Health Centre ( MUHC ) , Montreal , Canada .
METHODS	People with advanced cancer undergoing interdisciplinary assessment and rehabilitation with a fatigue level of 4 to 10 on a visual analogue scale .
METHODS	An 8-week fatigue-adapted , walking intervention , facilitated using a pedometer ( STEPS ) , and offered at the same time as or after rehabilitation .
METHODS	Measures of fatigue , physical function and well-being were administered at entry , and 8 , 16 and 24 weeks .
METHODS	Generalized estimating equations ( GEE ) estimated the odds of response for people receiving the STEPS program in comparison to the odds of response in the controls ( odds ratio , OR ) .
RESULTS	Twenty-six persons were randomized to three groups : during rehabilitation , after rehabilitation , and usual care .
RESULTS	For the fatigue measures the OR for STEPS offered at any time using an intention-to-treat approach was 3.68 ( 95 % CI : 1.05-12 .88 ) ; for the physical function measures , the OR was 1.40 ( 95 % CI : 0.41 - 4.79 ) and 2.36 ( 95 % CI : 0.66-8 .51 ) for the well-being measures .
CONCLUSIONS	Fifty percent of eligible people were able to participate .
CONCLUSIONS	This small trial suggests that a personalized exercise program reduces fatigue and that 100 people are needed in a full strength trial .

###24912498
BACKGROUND	Tuberculosis ( TB ) remains a global health problem , with vaccination likely to be a necessary part of a successful control strategy .
BACKGROUND	Results of the first Phase 2b efficacy trial of a candidate vaccine , MVA85A , evaluated in BCG-vaccinated infants were published last year .
BACKGROUND	Although no improvement in efficacy above BCG alone was seen , cryopreserved samples from this trial provide an opportunity to study the immune response to vaccination in this population .
METHODS	We investigated blood samples taken before vaccination ( baseline ) and one and 28 days post-vaccination with MVA85A or placebo ( Candin ) .
METHODS	The IFN - ELISpot assay was performed at baseline and on day 28 to quantify the adaptive response to Ag85A peptides .
METHODS	Gene expression analysis was performed at all three timepoints to identify early gene signatures predictive of the magnitude of the subsequent adaptive T cell response using the significance analysis of microarrays ( SAM ) statistical package and gene set enrichment analysis .
RESULTS	One day post-MVA85A , there is an induction of inflammatory pathways compared to placebo samples .
RESULTS	Modules associated with myeloid cells and inflammation pre - and one day post-MVA85A correlate with a higher IFN - ELISpot response post-vaccination .
RESULTS	By contrast , previous work done in UK adults shows early inflammation in this population is not associated with a strong T cell response but that induction of regulatory pathways inversely correlates with the magnitude of the T cell response .
RESULTS	This may be indicative of important mechanistic differences in how T cell responses develop in these two populations following vaccination with MVA85A .
CONCLUSIONS	The results suggest the capacity of MVA85A to induce a strong innate response is key to the initiation of an adaptive immune response in South African infants but induction of regulatory pathways may be more important in UK adults .
CONCLUSIONS	Understanding differences in immune response to vaccination between populations is likely to be an important aspect of developing successful vaccines and vaccination strategies .
BACKGROUND	ClinicalTrials.gov number NCT00953927 .

###25029835
OBJECTIVE	To evaluate and analyze the mechanism of Pizhen for the treatment of patients with scapular muscle fasciitis .
METHODS	One hundred and sixteen patients were divided into two groups according to random number table method , 58 cases in the treatment group and 58 cases in the control group .
METHODS	After treatment , 109 patients were followed up , and 7 patients lost follow-up ( 2 cases in the treatment group and 5 patients in the control group ) .
METHODS	In the treatment group , there were 15 males and 41 females , with a mean age of ( 28.02 + / - 4.85 ) years ; the course of disease ranged from 0.25 to 3 years ; and the patients were treated by Pizhen once a week , and 2 weeks were one treatment course .
METHODS	In the control group , there were 19 males and 34 females , with a mean age of ( 27.23 + / - 4.54 ) years old ; the course of disease ranged from 0.25 to 1 year ; and the patients were treated by acupuncture massage instrument , 20 minutes at a time , once a day for 2 weeks .
METHODS	Soft tissue displacement and banana area were tested by a soft tissue tension tester , pressure value was measured by pressure measuring instrument , and VAS was recorded by pain visual analog scale record .
RESULTS	There were significant differences in tissue displacement , banana area , pressure value and VAS between two groups before and after treatment .
RESULTS	The tissue displacement and pressure value in the treatment group were higher than those in the control group , while banana area and VAS were lower than those in the control group .
RESULTS	In the treatment group , 30 patients healed , 13 patients got marked improvement , 12 good and 1 poor ; while 16 patients healed , 19 patients got marked improvement ,11 good and 7 poor in the control group .
RESULTS	The therapeutic effects in the treatment group was better than that in the control group .
CONCLUSIONS	Pizhen is an effective method to treat pain in patients with scapular muscle fasciitis by relaxing tendon of soft tissue around pain point of scapular and relaxing compress and stimulation of nerves .

###25803949
BACKGROUND	Peer support involves people in recovery from mental illness supporting their peers .
OBJECTIVE	This mixed-methods pilot randomized control trial with qualitative interviews aimed to ( a ) compare peer support worker ( PSW ) and mental health worker ( MHW ) client outcomes and ( b ) provide estimates to inform the design of a larger study .
METHODS	Fifteen adults living with a mental illness and receiving services at a community health team were randomly assigned to a PSW or a MHW group .
METHODS	The Quality of Life Interview-Brief Version was administered at baseline and after 6 months of intervention .
METHODS	Participants completed a semi-structured exit interview .
RESULTS	While both groups improved from baseline to 6 months , the PSW group did not improve more than the MHW group .
RESULTS	Interviews highlighted therapeutic alliance and boundaries .
CONCLUSIONS	This research adds to existing literature that PSWs produce outcomes similar to nonpeer staff and struggle with boundaries related to their unique role .

###25569810
BACKGROUND	Adaptive support ventilation can speed weaning after coronary artery surgery compared with protocolized weaning using other modes .
BACKGROUND	There are no data to support this mode of weaning after cardiac valvular surgery .
BACKGROUND	Furthermore , control group weaning times have been long , suggesting that the results may reflect control group protocols that delay weaning rather than a real advantage of adaptive support ventilation .
METHODS	Randomized ( computer-generated sequence and sealed opaque envelopes ) , parallel-arm , unblinded trial of adaptive support ventilation versus physician-directed weaning after adult fast-track cardiac valvular surgery .
METHODS	The primary outcome was duration of mechanical ventilation .
METHODS	Patients aged 18 to 80 yr without significant renal , liver , or lung disease or severe impairment of left ventricular function undergoing uncomplicated elective valve surgery were eligible .
METHODS	Care was standardized , except postoperative ventilation .
METHODS	In the adaptive support ventilation group , target minute ventilation and inspired oxygen concentration were adjusted according to blood gases .
METHODS	A spontaneous breathing trial was carried out when the total inspiratory pressure of 15 cm H2O or less with positive end-expiratory pressure of 5 cm H2O .
METHODS	In the control group , the duty physician made all ventilatory decisions .
RESULTS	Median duration of ventilation was statistically significantly shorter ( P = 0.013 ) in the adaptive support ventilation group ( 205 [ 141 to 295 ] min , n = 30 ) than that in controls ( 342 [ 214 to 491 ] min , n = 31 ) .
RESULTS	Manual ventilator changes and alarms were less common in the adaptive support ventilation group , and arterial blood gas estimations were more common .
CONCLUSIONS	Adaptive support ventilation reduces ventilation time by more than 2 h in patients who have undergone fast-track cardiac valvular surgery while reducing the number of manual ventilator changes and alarms .

###25410432
BACKGROUND	Benign anorectal conditions are fairly common .
BACKGROUND	Physicians of various specialties usually see patients with these conditions before being referred to colorectal specialists , frequently with an incorrect diagnosis.We sought to evaluate the effect of attending an outpatient colorectal clinic by medical students on the diagnostic accuracy of these conditions .
METHODS	Over a 1-year period , medical students were randomized into a group that attended the clinic , and one that did not .
METHODS	Both groups were shown images of six common benign anorectal conditions .
METHODS	The overall diagnostic accuracy as well as the diagnostic accuracy for each one of these conditions was prospectively evaluated for both groups .
RESULTS	Nineteen students attended clinic and 17 did not .
RESULTS	Overall diagnostic accuracy was 80.6 % for students attending clinic and 43.1 % for non-attending students .
RESULTS	( p < 0.05 ) In the attending group , diagnostic accuracy was significantly greater for prolapsed internal hemorrhoids ( 73.6 % versus 35.2 % , p < 0.05 ) , thrombosed external hemorrhoid , ( 73.6 % versus 17.6 % , p < 0.05 ) fissure ( 100 % versus 47 % , p < 0.05 ) , and anal tags ( 68.4 % versus 11.7 % , p < 0.05 % ) .
CONCLUSIONS	Exposure to these conditions during surgical clerkships in medical school may help future specialists provide better care for patients with benign anorectal disorders .

###24371304
OBJECTIVE	The AMANDYSK trial was designed to assess long-term efficacy of chronic treatment with amantadine in patients with Parkinson disease ( PD ) and levodopa-induced dyskinesia ( LID ) .
METHODS	This was a 3-month , multicenter , randomized , double-blind , placebo-controlled , parallel-group , wash-out study conducted in 57 amantadine-treated ( 200 mg/d for 6 months ) dyskinetic patients with PD .
METHODS	The primary outcome measure was the change from baseline in a Unified Parkinson 's Disease Rating Scale ( UPDRS ) dyskinesia subscore ( items 32 [ duration ] + 33 [ severity ] ) .
METHODS	Secondary outcomes included other LID measurements ( `` responders '' analysis , premature dropout for LID , Abnormal Involuntary Movement Scale ) .
METHODS	Exploratory outcomes included time with troublesome dyskinesia as measured by diaries , UPDRS Motor Examination ( part III ) for motor symptoms of PD , and fatigue and apathy scores for nonmotor symptoms .
RESULTS	UPDRS items 32 + 33 deteriorated more in patients switched to placebo ( `` discontinuing '' group ) ( +1.7 2.0 units ; 95 % confidence interval 0.9 , 2.4 ) as compared with those maintained on amantadine ( `` continuing '' group ) ( +0.2 1.5 units ; 95 % confidence interval -0.4 , 0.8 ; p = 0.003 ) .
RESULTS	Secondary outcomes confirmed this difference because there were significantly more responders , more dropouts for LID , greater increase in `` ON '' time with troublesome dyskinesia , and greater worsening of Abnormal Involuntary Movement Scale score in the discontinuing group .
RESULTS	There were no between-group differences in the UPDRS Motor Examination , whereas apathy ( as measured by caregivers ) and fatigue scores tended to worsen more in patients randomized to placebo .
CONCLUSIONS	Wash-out of amantadine in dyskinetic patients with PD significantly worsened LID .
CONCLUSIONS	No significant effect was observed on motor parkinsonian symptoms , while exploratory outcomes suggested that amantadine might improve apathy and fatigue in such patients .
METHODS	This article provides Class II evidence that in patients with PD , withdrawing amantadine significantly aggravates LID in a median time of 7 days .

###24647500
BACKGROUND	The U.S. Food and Drug Administration has requested post-market surveillance data , including data on metal ion levels , regarding metal-on-metal total hip arthroplasty .
BACKGROUND	We performed a prospective , randomized study of metal ion levels in erythrocytes , serum , and whole blood at five years after 28 and 36-mm metal-on-metal and 28-mm metal-on-polyethylene total hip arthroplasty .
METHODS	One hundred and five enrolled patients were randomized equally to the three bearing surface options and were blinded with regard to their treatment group .
METHODS	Metal ion measurements and clinical evaluations were performed at regular intervals .
RESULTS	Cobalt and chromium ion levels in all blood sample types at the five-year time point were significantly lower in the metal-on-polyethylene group than in each of the two metal-on-metal groups ( p < 0.001 ) with the exception of chromium in erythrocytes ( p = 0.194 ) .
RESULTS	Cobalt in serum ( p = 0.029 ) and erythrocytes ( p = 0.002 ) showed significant increases from two to five years in the 36-mm metal-on-metal group ; similar increases were not seen in the 28-mm metal-on-metal group .
RESULTS	At five years , five patients in the 36-mm metal-on-metal group and none in the 28-mm metal-on-metal group had cobalt or chromium levels of > 7 ppb .
RESULTS	Correlations among levels in serum , erythrocyte , and whole blood were stronger for cobalt than for chromium .
RESULTS	One patient in the 36-mm metal-on-metal group underwent revision because of an adverse local tissue reaction .
CONCLUSIONS	The 36-mm metal-on-metal bearing underperformed the 28-mm metal-on-metal bearing with respect to metal ion levels .
CONCLUSIONS	The authors are closely following all patients treated with metal-on-metal total hip arthroplasty .

###25039273
OBJECTIVE	The aim of this study was to assess the safety and tolerability , pharmacokinetics and pharmacodynamics of LY3000328 when administered as single escalating doses to healthy volunteers .
METHODS	This was a phase 1 , placebo-controlled , dose escalation study with LY3000328 in 21 healthy male volunteers .
METHODS	Subjects were administered escalating LY3000328 doses up to 300mg with food in this single dose study .
METHODS	Blood samples were collected at set times post-dose for the assessment of LY3000328 pharmacokinetics and the measurement of cathepsin S ( CatS ) activity , CatS mass and calculated CatS specific activity .
RESULTS	All doses of LY3000328 were well tolerated , with linear pharmacokinetics up to the 300mg dose .
RESULTS	The pharmacodynamic activity of LY3000328 was measured ex vivo showing a biphasic response to LY3000328 , where CatS activity declines , then returns to baseline , and then increases to a level above baseline .
RESULTS	CatS mass was also assessed post-dose which increased in a dose-dependent manner , and continued to increase after LY3000328 had been cleared from the body .
RESULTS	CatS specific activity was additionally calculated to normalize CatS activity for changes in CatS mass .
RESULTS	This demonstrated the increase in CatS activity was attributable to the increase in CatS mass detected in plasma .
CONCLUSIONS	A specific inhibitor of CatS which is cleared quickly from plasma may produce a transient decrease in plasma CatS activity which is followed by a more prolonged increase in plasma CatS mass which may have implications for the future clinical development of inhibitors of CatS .

###24787266
OBJECTIVE	The clinical value of ischemic preconditioning ( IP ) on patients undergoing hepatectomy under portal triad clamping ( PTC ) is uncertain , especially for patients with liver cirrhosis .
OBJECTIVE	Hence , we conducted a prospective randomized controlled trial to test whether IP could protect liver against ischemic reperfusion ( IR ) injury after hepatectomy under PTC .
METHODS	One hundred patients , including 67 with cirrhosis , undergoing hepatectomy with PTC were randomly divided into IP and control groups .
METHODS	Liver function tests at postoperative days 1 , 3 , and 7 as well as postoperative morbidity , mortality , and duration of hospitalization were compared between the two groups .
RESULTS	The general clinical characteristics between both groups were comparable .
RESULTS	The duration of the operation , the amount of intraoperative blood loss , and the need and amount of perioperative blood transfusion were similar in both groups .
RESULTS	The postoperative levels of serum alanine aminotransferase ( ALT ) , aspartate aminotransferase ( AST ) , total bilirubin , and albumin were not statistically different between the two groups .
RESULTS	In addition , the morbidity and mortality rates and the duration of hospitalization were similar in both groups .
CONCLUSIONS	IP did not improve liver tolerance to IR injury after hepatectomy under PTC .
CONCLUSIONS	Therefore , the clinical use of IP can not be recommended as a standard procedure before PTC .

###25347938
OBJECTIVE	To assess the effects of renal impairment ( RI ) on the efficacy and safety of ipragliflozin in patients with type 2 diabetes mellitus ( T2DM ) .
METHODS	A cohort of Japanese patients with T2DM and mild to moderate RI and poor glycaemic control , despite diet/exercise therapy alone or diet/exercise therapy in combination with an oral hypoglycaemic agent ( an - glucosidase inhibitor , a sulfonylurea , or pioglitazone ) , were randomized in a double-blind manner to 50mg ipragliflozin or placebo once daily for 24weeks .
METHODS	The patients continued open-label ipragliflozin for a 28-week extension period ( total treatment duration : 52weeks ) .
RESULTS	Ipragliflozin significantly decreased glycated haemoglobin ( HbA1c ) and fasting plasma glucose ( FPG ) levels and body weight from baseline to week 24 ( last observation carried forward ) compared with placebo in all patients with RI .
RESULTS	The decreases in HbA1c and FPG levels were statistically significant in patients with mild RI , but not in patients with moderate RI .
RESULTS	Ipragliflozin significantly reduced body weight in both RI groups .
RESULTS	The improvements in glycaemic control were maintained in the 28-week extension period .
RESULTS	Ipragliflozin was associated with no clinically significant safety concerns , and its safety profiles were not influenced by the severity of RI .
CONCLUSIONS	Ipragliflozin significantly improved glycaemic control and body weight in patients with T2DM with mild RI , but did not improve glycaemic control in patients with moderate RI .
CONCLUSIONS	Ipragliflozin is a valid treatment option for patients with mild RI but not those with moderate RI .

###25252247
BACKGROUND	Use of granulocyte colony-stimulating factor ( G-CSF ) to treat damaged myocardium is a relatively new concept .
BACKGROUND	Clinical beneficial and safety outcomes are still controversial .
OBJECTIVE	The aim of this study was to evaluate recruitment of hematopoietic stem cells and therapeutic efficacy of G-CSF in the treatment of myxomatous mitral valve disease ( MMVD ) of dogs .
METHODS	Thirty client-owned MMVD dogs with clinical signs of heart failure were enrolled in a prospective double-blind , randomized , placebo-controlled study to compare the short-term effect of G-CSF ( n = 17 ) with control group ( n = 13 ) for identical periods .
METHODS	Clinical , hematological , and cardiovascular assessments were performed on days 0 , 1 , 3 , and 7 .
METHODS	Follow-up examination was conducted four weeks after the study .
RESULTS	Dogs treated with G-CSF had a significantly elevated white blood cell ( WBC ) ( 10 ( 3 ) / L ) count at day 3 compared with baseline ( from 10.23 4.42 to 42.84 11.84 ; P = .000 ) .
RESULTS	The WBC population was also changed ( elevated neutrophils and decreased lymphocytes ) and the numbers of CD34 + cells in the peripheral blood were also increased at day 3 .
RESULTS	However , the results of clinical , laboratory , and echocardiographic assessments did not differ significantly between the G-CSF treatment and control groups after four weeks .
CONCLUSIONS	G-CSF administration elevated the peripheral WBC count , especially neutrophils , and recruited hematopoietic stem cells .
CONCLUSIONS	However , positive effects of G-CSF on cardiac function were not detected during short-term monitoring .

###25261978
BACKGROUND	Metabolic syndrome ( MetS ) is a clustering of metabolic risk factors for cardiovascular diseases and type 2 diabetes .
BACKGROUND	The study aimed to estimate the prevalence of MetS , its components , and their associations among rural middle-aged population in Vietnam .
METHODS	A cross-sectional study with a representative sample ( n = 2443 ) was conducted to collect data on demographic , socioeconomic , anthropometric , lifestyles , plasma glucose , and lipid profile .
METHODS	The age - and sex-adjusted prevalences of MetS and its components were calculated using the direct standardization .
METHODS	Associations of risk factors with MetS were evaluated using logistic regression , taken into account the confounding factors .
RESULTS	The total age - and sex-adjusted prevalence ( 95 % CI ) of MetS was 16.3 % ( 14.0-18 .6 ) .
RESULTS	The most frequent component of MetS was high triglycerides ( 43.2 % ) , followed by low HDL-C ( 42.0 % ) , elevated blood pressure ( 29.2 % ) , high plasma glucose ( 14.3 % ) , and central obesity ( 12.3 % ) .
RESULTS	Of the total population , only 17.6 % did not have any component of MetS and more than 40 % had at least two MetS components .
RESULTS	The association of MetS with residence , age , body mass index , marital status , and siesta time per day was statistically significant in univariate analysis and replicated in multivariate analysis .
CONCLUSIONS	The MetS prevalence and its components are common and major public health burden in the middle-aged adults in Vietnam .
CONCLUSIONS	Habitants living in urban , being never-married , having an increase in age , BMI , and siesta time per day are significantly associated with MetS , and they should be paid much more attention for screening and implementing preventive activities .

###25932696
BACKGROUND	Among infants born prematurely , competence at oral feeding is necessary for growth and hospital discharge .
BACKGROUND	Extremely preterm ( EP ) infants ( 28 weeks of gestational age [ GA ] ) are at risk for a variety of medical complications , which can limit the infant 's capacity to develop oral feeding competence .
OBJECTIVE	This study examined feeding progression by assessing timing of acquisition of five early feeding milestones among EP infants and the impact of immaturity and medical complications .
METHODS	A chart review was conducted for 94 EP infants who participated in a larger longitudinal randomized study .
METHODS	Feeding progression was defined as infants ' postmenstrual age ( PMA ) at five milestones : first enteral feeding , full enteral feeding , first oral feeding , half oral feeding , and full oral feeding .
METHODS	GA at birth and five medical complications ( neurological risk , bronchopulmonary dysplasia , necrotizing enterocolitis , patent ductus arteriosus , and gastroesophageal reflux disease ) were used as potential factors influencing the feeding progression .
METHODS	Linear mixed models were used to examine feeding progression across the milestones and contributions of GA at birth and five medical complications on the progression , after controlling for milk type as a covariate .
RESULTS	EP infants gradually achieved feeding milestones ; however , the attainment of the feeding milestones slowed significantly for infants with younger GA at birth and the presence of medical complications , including neurological risk , bronchopulmonary dysplasia , necrotizing enterocolitis , and patent ductus arteriosus but not gastroesophageal reflux disease .
RESULTS	Milk type was a significant covariate for all analyses , suggesting that infants fed with breast milk achieved each of five milestones earlier than formula-fed infants .
CONCLUSIONS	Improved understanding of the timing of essential feeding milestones among EP infants and the contribution of specific medical conditions to the acquisition of these milestones may allow for more targeted care to support feeding skill development .

###25059927
BACKGROUND	Gastrointestinal bleeding ( GIB ) is a common and often serious complication after stroke .
BACKGROUND	Although several risk factors for post-stroke GIB have been identified , no reliable or validated scoring system is currently available to predict GIB after acute stroke in routine clinical practice or clinical trials .
BACKGROUND	In the present study , we aimed to develop and validate a risk model ( acute ischemic stroke associated gastrointestinal bleeding score , the AIS-GIB score ) to predict in-hospital GIB after acute ischemic stroke .
METHODS	The AIS-GIB score was developed from data in the China National Stroke Registry ( CNSR ) .
METHODS	Eligible patients in the CNSR were randomly divided into derivation ( 60 % ) and internal validation ( 40 % ) cohorts .
METHODS	External validation was performed using data from the prospective Chinese Intracranial Atherosclerosis Study ( CICAS ) .
METHODS	Independent predictors of in-hospital GIB were obtained using multivariable logistic regression in the derivation cohort , and - coefficients were used to generate point scoring system for the AIS-GIB .
METHODS	The area under the receiver operating characteristic curve ( AUROC ) and the Hosmer-Lemeshow goodness-of-fit test were used to assess model discrimination and calibration , respectively .
RESULTS	A total of 8,820 , 5,882 , and 2,938 patients were enrolled in the derivation , internal validation and external validation cohorts .
RESULTS	The overall in-hospital GIB after AIS was 2.6 % , 2.3 % , and 1.5 % in the derivation , internal , and external validation cohort , respectively .
RESULTS	An 18-point AIS-GIB score was developed from the set of independent predictors of GIB including age , gender , history of hypertension , hepatic cirrhosis , peptic ulcer or previous GIB , pre-stroke dependence , admission National Institutes of Health stroke scale score , Glasgow Coma Scale score and stroke subtype ( Oxfordshire ) .
RESULTS	The AIS-GIB score showed good discrimination in the derivation ( 0.79 ; 95 % CI , 0.764-0 .825 ) , internal ( 0.78 ; 95 % CI , 0.74-0 .82 ) and external ( 0.76 ; 95 % CI , 0.71-0 .82 ) validation cohorts .
RESULTS	The AIS-GIB score was well calibrated in the derivation ( P = 0.42 ) , internal ( P = 0.45 ) and external ( P = 0.86 ) validation cohorts .
CONCLUSIONS	The AIS-GIB score is a valid clinical grading scale to predict in-hospital GIB after AIS .
CONCLUSIONS	Further studies on the effect of the AIS-GIB score on reducing GIB and improving outcome after AIS are warranted .

###24405830
OBJECTIVE	To assess the immediate effect of a suboccipital muscle inhibition ( SMI ) technique on : ( a ) neck pain , ( b ) elbow extension range of motion during the upper limb neurodynamic test of the median nerve ( ULNT-1 ) , and ( c ) grip strength in subjects with cervical whiplash ; and determine the relationships between key variables .
METHODS	Randomised , single-blind , controlled clinical trial .
METHODS	Faculty of Nursing , Physiotherapy and Podiatry , University of Seville , Spain .
METHODS	Forty subjects { mean age 34 years [ standard deviation ( SD ) 3.6 ] } with Grade I or II cervical whiplash and a positive response to the ULNT-1 were recruited and distributed into two study groups : intervention group ( IG ) ( n = 20 ) and control group ( CG ) ( n = 20 ) .
METHODS	The IG underwent the SMI technique for 4minutes and the CG received a sham ( placebo ) intervention .
METHODS	Measures were collected immediately after the intervention .
METHODS	The primary outcome was elbow range of motion during the ULNT-1 , measured with a goniometer .
METHODS	The secondary outcomes were self-perceived neck pain ( visual analogue scale ) and free-pain grip strength , measured with a digital dynamometer .
RESULTS	The mean baseline elbow range of motion was 116.0 ( SD 10.2 ) for the CG and 130.1 ( SD 7.8 ) for the IG .
RESULTS	The within-group comparison found a significant difference in elbow range of motion for the IG [ mean difference -15.4 , 95 % confidence interval ( CI ) -20.1 to -10.6 ; P = 0.01 ] , but not for the CG ( mean difference -4.9 , 95 % CI -11.8 to 2.0 ; P = 0.15 ) .
RESULTS	In the between-group comparison , the difference in elbow range of motion was significant ( mean difference -10.5 , 95 % CI -18.6 to -2.3 ; P = 0.013 ) , but the differences in grip strength ( P = 0.06 ) and neck pain ( P = 0.38 ) were not significant .
CONCLUSIONS	The SMI technique has an immediate positive effect on elbow extension in the ULNT-1 .
CONCLUSIONS	No immediate effects on self-perceived cervical pain or grip strength were observed .

###24519843
BACKGROUND	A growing number of elderly patients with end-stage renal disease start dialysis .
BACKGROUND	We examined elderly ( 65 years ) patients ' views about their decision-making experience after starting dialysis in comparison with patients aged 50-64 years , and patients 49 years .
METHODS	Ninety-nine patients from 15 outpatient dialysis centers in North Carolina , USA completed a semi-structured interview asking them about the context of decision-making and their decision-making experience , and a 10-item investigator-developed Informed Decision-Making ( IDM ) questionnaire with binary response options ( yes/no ) .
RESULTS	While IDM scores were low for all three groups ( < 5 out of 10 ) , they were significantly lower for the older group compared to the other two younger groups ( p = 0.02 ) .
RESULTS	A significantly lower percentage of the older group said that the doctor explained underlying conditions that led to kidney failure ( p = 0.04 ) , the impact of dialysis on daily life ( p = 0.04 ) , and the life-long need for dialysis ( p < 0.01 ) , and that the doctor tried to make sure the patient understood the information ( p = 0.01 ) .
RESULTS	Also a significantly higher percentage of elderly patients felt the decision was made by the doctor rather than on their own or with their family , or collaboratively with the doctor ( p = 0.04 ) .
CONCLUSIONS	Informed decision-making is significantly poorer in patients aged 65 years or older than in younger patients .
CONCLUSIONS	Clinicians should communicate clearly about the benefits and burdens of dialysis to older adults and provide an opportunity for them to understand the significant trade-offs that dialysis may require .

###24954228
BACKGROUND	The combination of oral vinorelbine plus cisplatin has been studied in numerous trials as first-line treatment of patients with non-small cell lung cancer ( NSCLC ) regardless of histologic subtype .
BACKGROUND	NAVoTrial 01 is the first study that explores this combination specifically in nonsquamous ( NS ) NSCLC by assessing the feasibility of this doublet ( ratio 1:2 ) in an investigational approach .
BACKGROUND	A reference arm with pemetrexed plus cisplatin was included .
BACKGROUND	Maintenance therapy with single-agent therapy after 4 cycles of combination therapy was included in the study schedules because it reflected a trend in first-line treatment of NSCLC .
METHODS	Stage IIIB/IV untreated/relapsed patients with NS NSCLC received a 3-week cycle of pemetrexed 500 mg/m ( 2 ) and cisplatin 75 mg/m ( 2 ) on day 1 ( arm A ) or oral vinorelbine 80 mg/m ( 2 ) on days 1 and 8 ( first cycle 60 mg/m ( 2 ) ) and cisplatin 80 mg/m ( 2 ) on day 1 ( arm B ) .
METHODS	After 4 cycles , patients without disease progression received single-agent maintenance treatment with pemetrexed or oral vinorelbine .
RESULTS	Overall , 153 patients were randomized ( arm A/arm B : 51/102 ) .
RESULTS	Disease control rate ( % ) for arm A was 76.5 ( 95 % confidence interval [ CI ] , 62.5-87 .2 ) and for arm B it was 75.0 ( 95 % CI , 65.3-83 .1 ) , Response rates for arm A were 31.4 % ( 95 % CI , 19.1-45 .9 ) and for arm B were 24.0 % ( 95 % CI , 16.0-33 .6 ) .
RESULTS	Median progression-free survival for arm A was 4.3 months ( 95 % CI , 3.8-5 .6 ) and for arm B it was 4.2 months ( 95 % CI , 3.6-4 .7 ) .
RESULTS	Median survival for arm A was 10.8 months ( 95 % CI , 7.0-16 .4 ) and for arm B it was 10.2 months ( 95 % CI , 7.8-11 .9 ) .
RESULTS	Main grade 3/4 hematologic toxicities were neutropenia 18.3 % ( arm A ) and 44.0 % ( arm B ) , whereas febrile neutropenia was reported in 2 % of patients in each arm .
CONCLUSIONS	Oral vinorelbine and cisplatin had an efficacy in line with that achieved with a standard treatment such as pemetrexed and cisplatin , coupled with an acceptable safety profile .

###24813167
OBJECTIVE	To compare radiation exposure of nurses when performing nursing tasks associated with interventional procedures depending on whether or not the nurses called out to the operator before approaching the patient .
METHODS	In a prospective study , 93 interventional radiology procedures were randomly divided into a call group and a no-call group ; there were 50 procedures in the call group and 43 procedures in the no-call group .
METHODS	Two monitoring badges were used to calculate effective dose of nurses .
METHODS	In the call group , the nurse first told the operator she was going to approach the patient each time she was about to do so .
METHODS	In the no-call group , the nurse did not say anything to the operator when she was about to approach the patient .
RESULTS	In all the nursing tasks , the equivalent dose at the umbilical level inside the lead apron was below the detectable limit .
RESULTS	The equivalent dose at the sternal level outside the lead apron was 0.16 Sv 0.41 per procedure in the call group and 0.51 Sv 1.17 per procedure in the no-call group .
RESULTS	The effective dose was 0.018 Sv 0.04 per procedure in the call group and 0.056 Sv 0.129 per procedure in the no-call group .
RESULTS	The call group had a significantly lower radiation dose ( P = .034 ) .
CONCLUSIONS	Radiation doses of nurses were lower in the group in which the nurse called to the operator before she approached the patient .

###24393349
OBJECTIVE	To characterize preinjection intraocular pressure ( IOP ) in eyes receiving monthly ranibizumab versus sham or verteporfin photodynamic therapy ( PDT ) for age-related macular degeneration ( AMD ) .
METHODS	Post hoc analysis of IOP data from 2 phase 3 clinical trials , the Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab in the Treatment of Neovascular AMD ( MARINA ) and the Anti-VEGF Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in AMD ( ANCHOR ) trial .
METHODS	All safety-evaluable patients who received 1 or more injections of sham or PDT or of ranibizumab and had 1 or more postbaseline IOP measurements recorded for the study eye .
METHODS	Preinjection IOP measurements for study eyes ( n = 1125 ) and fellow eyes in MARINA and ANCHOR at baseline and at each monthly visit through month 24 were analyzed .
METHODS	End points evaluated were maximum preinjection IOP during the 24-month treatment period ; any occurrence of absolute preinjection IOP of 21 mmHg or more , 25 mmHg or more , or 30 mmHg or more ; any occurrence of IOP increase of 6 mmHg or more , 8 mmHg or more , or 10 mmHg or more from baseline ; any combination of IOP increase of 6 mmHg or more or 8 mmHg or more from baseline with concurrent absolute preinjection IOP of 21 mmHg or more or 25 mmHg or more ; glaucoma-related adverse events ; new glaucoma medications used for 45 days or more ; and glaucoma filtration or laser surgeries .
RESULTS	Across treatment groups , 60.1 % to 70.9 % of study eyes had a maximum preinjection IOP of less than 21 mmHg .
RESULTS	Comparing ranibizumab 0.5 mg versus sham or PTD treatment , respectively : 39.9 % versus 29.1 % and 10.9 % versus 5.1 % had maximum preinjection IOPs of 21 mmHg or more or 25 mmHg or more , respectively ; 44.1 % versus 29.9 % and 24.2 % versus 13.6 % had IOP increases from baseline of 6 mmHg or more or 8 mmHg or more , respectively ; 26.1 % versus 13.6 % and 16.8 % versus 9.0 % had 1 or more IOP increase from baseline of 6 mmHg or more or 8 mmHg or more , respectively , with a concurrent IOP of 21 mmHg or more ; 9.6 % versus 3.7 % and 7.5 % versus 2.4 % had 1 or more IOP increase from baseline of 6 mmHg or more or 8 mmHg or more , respectively , with a concurrent IOP of 25 mmHg or more .
RESULTS	No differences were observed in fellow eyes .
CONCLUSIONS	Most ranibizumab-treated eyes did not experience sustained preinjection IOP of 21 mmHg or more ( > 2 consecutive visits ) over 24 months .
CONCLUSIONS	When evaluating the combined IOP end point , more ranibizumab-treated eyes had 1 or more IOP increase from baseline of 6 mmHg or more or 8 mmHg or more , with concurrent highest IOPs of 21 mmHg or more and 25 mmHg or more versus sham or PDT .
CONCLUSIONS	Intraocular pressure should be monitored in eyes receiving ranibizumab .

###25897757
BACKGROUND	Depressive and anxiety disorders are highly prevalent , but only a small percentage ( approximately 50 % ) of patients receive appropriate treatment .
BACKGROUND	Relevant barriers include communication and coordination gaps between different providers that result from the lack of integration between different care-giving systems .
BACKGROUND	Aftercare following inpatient treatment represents one of these gaps because systematic follow-up care does not exist .
BACKGROUND	Case management-based aftercare coordination by phone might be a promising approach to overcoming this gap and improving long-term treatment outcomes .
BACKGROUND	Case management is a patient-centered and situation-based approach comprising systematic tracking and support of patients by a case manager .
BACKGROUND	The aim of this study is to evaluate the effectiveness of aftercare coordination by phone for patients with depressive and anxiety disorders .
METHODS	The effectiveness of aftercare coordination will be investigated in a prospective randomized controlled trial in four psychotherapeutic inpatient routine care units ( St. Franziska-Stift Bad Kreuznach , MediClin Seepark Klinik Bad Bodenteich , Segeberger Kliniken Gruppe Bad Segeberg and Luisenklinik Bad Drrheim ) .
METHODS	The patients receiving aftercare coordination ( intervention group ; IG ) will be compared with those who receive treatment as usual ( TAU control group ; CG ) .
METHODS	Eligible patients will be required to have a diagnosis of an anxiety and/or depressive disorder and a recommendation for follow-up outpatient psychotherapy .
METHODS	The aftercare coordination consists of six phone contacts at intervals of two weeks that are performed by therapists in the inpatient units .
METHODS	The patients will complete questionnaires at discharge ( t1 ) , 3months after discharge ( i.e. , at the end of the intervention ( t2 ) ) and 9months after discharge ( t3 ) .
METHODS	The primary outcome will be change in symptom severity from t1 to t3 , the secondary outcomes will be health-related quality of life and the proportion of patients who manage to begin outpatient psychotherapy by t3 .
CONCLUSIONS	This study will determine whether case management-based aftercare coordination by phone is an adequate approach for overcoming treatment barriers in the clinical pathways of patients with depressive and anxiety disorders .
CONCLUSIONS	If proven effective , an accessible supplementary treatment approach that will help to maintain and even improve long-term treatment outcomes will be made available for patients following inpatient treatment .
BACKGROUND	ClinicalTrials.gov : ( NCT02044913 ) .

###24983199
OBJECTIVE	To investigate whether repetitive sessions of formative self-testing ( RFST ) result in an equal cardiopulmonary resuscitation ( CPR ) skill level compared to repetitive sessions of formative self-testing with additional practice ( RFSTAP ) .
METHODS	In a non-inferiority trial , 196 third-year medical students were randomised to an RFST or RFSTAP group .
METHODS	Testing and practising took place in a self-learning station equipped with a manikin connected to a computer .
METHODS	Each cycle of RFST consisted of a 2-min CPR test followed by feedback and feedforward .
METHODS	In the RFSTAP group , additional practice consisted of CPR exercises with a computer voice feedback .
METHODS	To be successful , a combined score consisting of 70 % compressions with a depth of 50 mm and 70 % compressions with complete release ( < 5 mm ) and a compression rate of 100-120 min ( -1 ) and 70 % ventilations with a volume of 400-1000 ml had to be achieved within 6 weeks .
METHODS	Skill retention was measured after 6 months .
METHODS	The non-inferiority margin was predefined as a 10 % difference in success rate .
RESULTS	After six weeks the success rate in both groups was 96 % : 99/103 ( RFST ) and 89/93 ( RFSTAP ) .
RESULTS	After 6 months , the success rate in the competent students was 26/96 ( 27 % ) for RFST and 32/86 ( 37 % ) for RFSTAP ( three students dropped out in each group ) .
RESULTS	The difference in the success rate between RFSTAP and RFST was 10 % and 90 % ( CI -2 to 23 % ) , respectively .
RESULTS	As the upper bound exceeded 10 % , non-inferiority was inconclusive .
RESULTS	For each CPR skill separately , RFST was non-inferior for ventilation and complete release , superior for compression depth and inferior for compression rate .
CONCLUSIONS	RFST and RFSTAP were equally effective to refresh skills within 6 weeks .
CONCLUSIONS	After 6 months , non-inferiority was inconclusive for the combined score .
CONCLUSIONS	Our results indicate the potential of RFST to refresh CPR skills .

###24533664
OBJECTIVE	Little is known about the long-term effects of intensive multifactorial treatment early in the diabetes disease trajectory .
OBJECTIVE	In the absence of long-term data on hard outcomes , we described change in 10-year modelled cardiovascular risk in the 5 years following diagnosis , and quantified the impact of intensive treatment on 10-year modelled cardiovascular risk at 5 years .
METHODS	In a pragmatic , cluster-randomized , parallel-group trial in Denmark , the Netherlands and the UK , 3057 people with screen-detected Type 2 diabetes were randomized by general practice to receive ( 1 ) routine care of diabetes according to national guidelines ( 1379 patients ) or ( 2 ) intensive multifactorial target-driven management ( 1678 patients ) .
METHODS	Ten-year modelled cardiovascular disease risk was calculated at baseline and 5 years using the UK Prospective Diabetes Study Risk Engine ( version 3 ) .
RESULTS	Among 2101 individuals with complete data at follow up ( 73.4 % ) , 10-year modelled cardiovascular disease risk was 27.3 % ( sd 13.9 ) at baseline and 21.3 % ( sd 13.8 ) at 5-year follow-up ( intensive treatment group difference -6.9 , sd 9.0 ; routine care group difference -5.0 , sd 12.2 ) .
RESULTS	Modelled 10-year cardiovascular disease risk was lower in the intensive treatment group compared with the routine care group at 5 years , after adjustment for baseline cardiovascular disease risk and clustering ( -2.0 ; 95 % CI -3.1 to -0.9 ) .
CONCLUSIONS	Despite increasing age and diabetes duration , there was a decline in modelled cardiovascular disease risk in the 5 years following diagnosis .
CONCLUSIONS	Compared with routine care , 10-year modelled cardiovascular disease risk was lower in the intensive treatment group at 5 years .
CONCLUSIONS	Our results suggest that patients benefit from intensive treatment early in the diabetes disease trajectory , where the rate of cardiovascular disease risk progression may be slowed .

###25675558
OBJECTIVE	To explore the difference in the efficacy and effect mechanism of subcortical ischemic vascular disease ( SIVD ) complicated with depression between acupuncture and medication .
METHODS	Sixty patients were randomized-into an acupuncture group and a medication group , 30 cases in each one .
METHODS	In the acupuncture group , acupuncture was applied to Baihui ( GV 20 ) , Shuigou ( GV 26 ) , Fengfu ( GV 16 ) , Fengchi ( GB 20 ) and the others , once a day , 6 times a week .
METHODS	The treatment of 4 weeks made one session and totally 2 sessions were required .
METHODS	In the medication group , nimodipine 30 mg , three times a day and fluoxetine 20 mg , once a day were prescribed for oral administration , for 8 weeks totally .
METHODS	Before treatment , at the end of the 4th week and at the end of the 8th week of treatment , cerebral blood flow velocity ( CBFV ) and solubility CD40 ligand ( sCD40L ) were determined respectively .
METHODS	The scores in Montreal cognitive assessment ( MoCA ) and Hamilton ' s depression scale ( HAMD ) were evaluated in the two groups .
METHODS	The efficacies on cognitive function and depression symptoms were compared in the patients between the two groups .
METHODS	Results Compared with the outcome before treatment , mean blood flow velocity ( Vm ) of middle cerebral artery ( MCA ) , anterior cerebral artery ( ACA ) and posterior cerebral artery ( PCA ) was increased significantly at the end of the 4th week of treatment in the two groups ( all P < 0.05 ) .
METHODS	At the end of the 8th week , Vm was increased much significantly ( all P < 0.01 ) .
METHODS	The differences were not significant in comparison between the two groups ( all P > 0.05 ) .
METHODS	Compared with the expression before treatment , sCD40L was reduced significantly after treatment in the patients of the two groups ( all P < 0.01 ) , but the differ - ence was not significant between the two groups ( all P > 0.05 ) .
METHODS	Compared with that before treatment , MoCA score was increased significantly after treatment in the two groups ( all P < 0.01 ) , HAMD score was reduced sig - nificantly ( all P < 0.01 ) , the differences were not significant in comparison between the two groups ( all P > 0.05 ) .
METHODS	The total effective rate of cognitive improvement was 86.7 % ( 26/30 ) in the acupuncture group and was 80.0 % ( 24/30 ) in the medication group , the differences were not significant in comparison of the two groups ( P > 0.05 ) .
METHODS	The total effective rate of the improvement in depression was 93.3 % ( 21/30 ) in the acupuncture group and was 86.7 % ( 26/30 ) in the medication group , the differences were not significant in comparison of the two groups ( P > 0.05 ) .
CONCLUSIONS	Acupuncture could significantly increases CBFV and reduces serum sCD40L expressions in the patients of SIVD complicated with depression , and significantly improves cognitive function and relieves depression symptoms .
CONCLUSIONS	The efficacy of it is similar to that of western medication .
CONCLUSIONS	The increase of serum sCD40L expression is possibly involved in the occurrence and development of SIVD .
CONCLUSIONS	Reducing sCD40L expression contributes to the alleviation of damage induced by cerebral ischemia and reperfusion .

###26106113
OBJECTIVE	Randomized trial evidence on the risk/benefit ratio of thrombolysis for mild stroke is limited .
OBJECTIVE	We sought to determine the efficacy of intravenous recombinant tissue-type plasminogen activator ( IV r-tPA ) in a subset of patients with mild deficit in the third International Stroke Trial ( IST-3 ) .
METHODS	IST-3 compared IV r-tPA with control within 6 hours of onset in patients for whom IV r-tPA was considered promising but unproven .
METHODS	Analysis was restricted to subjects randomized within 3 hours of onset with a baseline National Institutes of Health Stroke Scale 5 , pretreatment blood pressure < 185/110 , and no other r-tPA exclusion criteria .
METHODS	We compared r-tPA and control arms for primary ( Oxfordshire Handicap Score [ OHS ] 0-2 ) and secondary ( ordinal OHS and OHS 0-1 ) outcomes at 6 months .
RESULTS	Among 3035 IST-3 subjects , 612 ( 20.2 % ) had an National Institutes of Health Stroke Scale 5 ; of these 106 ( 17.6 % ) met the restricted criteria .
RESULTS	Allocation to r-tPA was associated with an increase in OHS 0 to 2 ( 84 % r-tPA versus 65 % control ; adjusted odds ratio , 3.31 ; 95 % confidence interval , 1.24-8 .79 ) and a favorable shift in OHS distribution ( adjusted odds ratio , 2.38 ; 95 % confidence interval , 1.17-4 .85 ) .
RESULTS	There was no significant effect of r-tPA on OHS 0 to 1 ( 60 % versus 51 % ; adjusted odds ratio , 1.92 ; 95 % confidence interval , 0.83-4 .43 ) .
CONCLUSIONS	This post hoc analysis in a highly selected sample of IST-3 supports the rationale of A Study of the Efficacy and Safety of Activase ( Alteplase ) in Patients With Mild Stroke ( PRISMS ) trial-a randomized , phase IIIb study to evaluate IV r-tPA in mild ischemic stroke .

###24637789
OBJECTIVE	The ACS1 ( Azilsartan Circadian and Sleep Pressure - the first study ) is a multicenter , randomized , open-label , two parallel-group study carried out to investigate the efficacy of an 8-week oral treatment with azilsartan 20 mg in comparison with amlodipine 5 mg .
METHODS	The patients with stage I or II primary hypertension will be randomly assigned to either an azilsartan group ( n = 350 ) or an amlodipine group ( n = 350 ) .
METHODS	The primary endpoint is a change in nocturnal systolic blood pressure ( BP ) as measured by ambulatory BP monitoring at the end of follow-up relative to the baseline level during the run-in period .
METHODS	In addition , we will carry out the same analysis after dividing four different nocturnal BP dipping statuses ( extreme-dippers , dippers , nondipper , and risers ) .
CONCLUSIONS	The findings of this study will help in establishing an appropriate antihypertensive treatment for hypertensive patients with a disrupted circadian BP rhythm .

###25567476
BACKGROUND	Intrathecal morphine-induced pruritus is a very common side-effect that is difficult to prevent or treat .
BACKGROUND	Central and peripheral mechanisms are believed to be involved .
BACKGROUND	The aim of this study was to determine if a peripherally acting , - opioid antagonist would reduce morphine-induced pruritus .
METHODS	We conducted a multicentre , randomized , blinded , placebo-controlled trial of women having elective Caesarean section under spinal anaesthesia with intrathecal morphine 100 g.
METHODS	After delivery , participants received either subcutaneous methylnatrexone bromide 12 mg ( MNTX group , n = 69 ) or saline ( placebo group , n = 68 ) .
METHODS	Pruritus , nausea , pain , analgesic use , and side-effects were assessed at 2 , 4 , 8 , and 24 h.
METHODS	The primary outcome was the severity of pruritus ( 0-10 score ) .
RESULTS	One hundred and thirty-seven women completed the study , with five major protocol violations .
RESULTS	There was no statistically significant difference between the MNTX and placebo groups for the median ( IQR ) pruritus AUC scores [ 24 ( 9-47 ) vs 36 ( 11-68 ) , median difference 8.5 , 95 % confidence interval ( CI ) 0-20 , P = 0.09 ] or the worst pruritus score [ 3 ( 2-7 ) vs 5 ( 2-6 ) , median difference 1 , 95 % CI 0-2 , P = 0.24 ] .
RESULTS	The incidence of pruritus was 84 % in the MNTX group and 88 % in the placebo group ( P = 0.48 ) .
RESULTS	Analgesic and gastrointestinal outcomes did not significantly differ between the groups .
CONCLUSIONS	A single dose of subcutaneous methylnaltrexone bromide 12 mg did not reduce the overall severity or incidence of pruritus .
CONCLUSIONS	In this study , treatment with a peripherally acting - opioid antagonist was generally ineffective against intrathecal morphine-induced pruritus , but a small clinical effect can not be excluded .
BACKGROUND	Australian New Zealand Clinical Trials Registry ( ACTRN12611000345987 ) .

###24469645
OBJECTIVE	To compare the efficacy of different treatment strategies for distal ureteral stones smaller than 10 mm .
METHODS	A total 127 patient were included in the study .
METHODS	Based on the treatment modality , patients were divided into three groups.Patients in group 1 only received conventional treatment including daily hydration of 2500 mL , ciprofloxacin , diclofenac sodium and a spasmolytic agent ; group 2 patients received conventional treatment ( daily hydration of 2500 mL , ciprofloxacin , diclofenac sodium and a spasmolytic agent ) and tamsulosin 0.4 mg orally daily for 4 weeks ; and group 3 patients underwent ureteroscopy .
METHODS	Patients were further subdivided into 2 categories based on maximum stone diameter : category A ( less than 5 mm ) and category B ( 5.0-9 .9 mm ) .
METHODS	Following treatment , all groups were compared in terms of stone-free rate and time to expulsion .
RESULTS	Following treatment , the stone-free rates for groups 1 , 2 and 3 were 48.7 % , 59.5 % and 95.6 % , respectively ( P < .0001 ) .
RESULTS	The mean expulsion times for groups 1 , 2 and 3 were 15.3 5.33 , 15.1 5.5 and 1.95 2.2 days , respectively ( P < .001 ) .
RESULTS	Compared to the other treatments , the stone-free rate and mean expulsion time in the ureteroscopy group were significantly increased and decreased , respectively .
CONCLUSIONS	There are several treatment options for distal ureteral stones .
CONCLUSIONS	Based on our data , we conclude that ureterorenoscopy should be the standard of care for distal ureteral stones smaller than 10 mm .

###24863090
OBJECTIVE	To evaluate if a supervised exercise training program improves the quality of life ( QoL ) of differentiated thyroid carcinoma ( DTC ) patients on TSH-suppressive therapy with levothyroxine ( L-T4 ) .
METHODS	Initially , a cross-sectional study was performed to compare the QoL and the health-related quality of life ( HRQoL ) between subclinical hyperthyroidism ( SCH ) patients ( n = 33 ) and euthyroid subjects ( EU ; n = 49 ) .
METHODS	In the prospective phase of the study , SCH patients were randomized in a non-blinded fashion to either participate ( SCH-Tr = trained patients ; n = 16 ) or not ( SCH-Sed = untrained patients ; n = 17 ) in a supervised exercise training program .
METHODS	The exercise program consisted of 60 minutes of aerobic and stretching exercises , twice a week , during twelve weeks .
METHODS	The QoL was assessed by the application of the WHOQOL-Bref , and the SF-36 was used to assess the HRQoL .
RESULTS	SCH patients had statistically lower scores than EU on the `` physical '' domain of WHOQOL-Bref , besides `` physical function '' , `` role-physical '' , `` bodily pain '' , `` general health '' , `` vitality '' , `` role-emotional '' , and `` mental-health '' domains of SF-36 .
RESULTS	After three months , SCH-Tr patients showed improvement in the `` physical '' and `` psychological '' domains of WHOQOL-Bref ( p < 0.05 ) , and in the `` physical function '' , `` role-physical '' , `` bodily pain '' , `` vitality '' and `` mental health '' domains of SF-36 .
CONCLUSIONS	Patients on TSH-suppressive therapy with L-T4 for DTC had impaired QoL and HRQoL compared to EU , but it was improved after 3-months of an exercise training program .
CONCLUSIONS	Exercise seems to play an important role in the follow-up of DTC patients , since it seems to minimize the adverse effects of the treatment on QoL and HRQoL .

###25271049
BACKGROUND	The long-term efficacy of - blockers in patients with and without myocardial infarction ( MI ) is controversial .
RESULTS	This is post hoc analysis from the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization , Management , and Avoidance ( CHARISMA ) trial of 4772 patients with prior MI , 7804 patients with known atherothrombosis , and 2101 patients with risk factors alone but without heart failure .
RESULTS	Primary outcome was a composite of nonfatal MI , stroke , or cardiovascular mortality .
RESULTS	The cohorts were divided into 2 groups based on baseline - blocker use .
RESULTS	In the propensity score-matched prior MI cohort , after 28 months of follow-up , - blocker use was associated with a 31 % lower risk of the primary outcome ( 70 [ 7.1 % ] versus 100 [ 10.2 % ] ; hazards ratio , 0.69 ; 95 % confidence interval , 0.50-0 .94 ; P = 0.021 ) , driven by a lower risk of recurrent MI ( 33 [ 3.4 % ] versus 48 [ 4.9 % ] ; hazards ratio , 0.62 ; 95 % confidence interval , 0.39-1 .00 ; P = 0.049 ) with no difference in mortality ( 52 [ 5.3 % ] versus 66 [ 6.7 % ] ; P = 0.20 ) .
RESULTS	In the known atherothrombotic disease and the risk factors alone cohorts , - blocker use was not associated with lower ischemic outcomes , whereas a trend toward a higher risk of stroke ( 3.5 % versus 1.5 % ; hazards ratio , 2.13 ; 95 % confidence interval , 0.92-4 .92 ; P = 0.079 ) was observed in the risk factors alone cohort .
RESULTS	This higher stroke risk was significant in the regression model adjusted to the propensity score ( hazards ratio , 2.69 ; 95 % confidence interval , 1.33-5 .44 ; P = 0.006 ) and in the multivariable models .
CONCLUSIONS	- blocker use in patients with prior MI but no heart failure was associated with a lower composite cardiovascular outcome driven by lower risk of recurrent MI with no difference in mortality .
CONCLUSIONS	However , - blocker use was not associated with lower cardiovascular events in those without MI , with a suggestion of inferior outcome with regard to stroke risk .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00050817 .

###24885904
BACKGROUND	In Denmark 8,000 to 10,000 people will attempt suicide each year .
BACKGROUND	The Centre of Excellence in Suicide Prevention in the Capital Region of Denmark is treating patients with suicidal behavior , and a recent survey has shown that 30 % of the patients are suffering from borderline personality disorder .
BACKGROUND	The majority of patients ( 70 % to 75 % ) with borderline personality disorder have a history of deliberate self-harm and 10 % have a lifetime risk to die by suicide .
BACKGROUND	The DiaS trial is comparing dialectical behavior therapy with collaborative assessment and management of suicidality-informed supportive psychotherapy , for the risk of repetition of deliberate self-harm in patients with a recent suicide attempt and personality traits within the spectrum of borderline personality disorder .
BACKGROUND	Both treatments have previously shown effects in this group of patients on suicide ideation and self-harm compared with treatment as usual .
METHODS	The trial is designed as a single-center , two-armed , parallel-group observer-blinded randomized clinical superiority trial .
METHODS	We will recruit 160 participants with a recent suicide attempt and at least two traits of the borderline personality disorder from the Centre of Excellence in Suicide Prevention , Capital Region of Denmark .
METHODS	Randomization will be performed though a centralized and computer-generated approach that conceals the randomization sequence .
METHODS	The interventions that are offered are a modified version of a dialectical behavior therapy program lasting 16 weeks versus collaborative assessment and management of suicidality-informed supportive psychotherapy , where the duration treatment will vary in accordance with established methods up to 16 weeks .
METHODS	The primary outcome measure is the ratio of deliberate self-harming acts including suicide attempts measured at week 28 .
METHODS	Other exploratory outcomes are included such as severity of symptoms , suicide intention and ideation , depression , hopelessness , self-esteem , impulsivity , anger , and duration of respective treatments .
BACKGROUND	Clinical Trial.gov : NCT01512602 .

###24497796
OBJECTIVE	The aim of our study was to evaluate the differences between sclerotherapy with and without ethanol concentration monitoring for the treatment of simple renal cysts .
METHODS	Sixty-seven patients with 70 simple renal cysts were randomly assigned to two groups in a 12-month prospective controlled trial .
METHODS	One group ( group A ) was treated with computed tomography ( CT ) - guided sclerotherapy without ethanol concentration monitoring ( 33 patients with 35 cysts ) , whereas the other group ( group B ) had ethanol concentration monitoring ( 34 patients with 35 cysts ) during the procedure .
METHODS	Treatment outcomes between the two groups were compared 12 months later with follow-up ultrasound examination .
RESULTS	After the 12-month follow-up period , the overall success rate was 74.3 % in group A and 94.3 % in group B ( p = 0.022 ) .
RESULTS	The mean cyst size before and after treatment was 8.6 2.0 cm and 2.3 2.9 cm , respectively , in group A , and 8.4 1.7 cm and 0.8 1.9 cm , respectively , in group B.
RESULTS	The final size of the cysts in group B was significantly smaller than that in group A ( p = 0.015 ) .
RESULTS	The likelihood of treatment with ethanol concentration monitoring being successful was approximately 16 times higher than without ethanol concentration monitoring ( p = 0.026 ; odds ratio = 15.7 ; 95 % confidence interval : 1.38-179 .49 ) .
RESULTS	There were no major complications in either group .
CONCLUSIONS	Monitoring of Hounsfield units ( HU ) of ethanol by CT is an effective method in the treatment of simple renal cysts with ethanol sclerotherapy .
CONCLUSIONS	The ethanol sclerotherapy procedure can be terminated at the point of clear fluid aspiration because the HU ( -190 ) of CT scan corresponds to it .

###25908486
OBJECTIVE	To correlate aqueous vasoactive protein changes with macular edema after dexamethasone implant in retinal vein occlusion ( RVO ) .
METHODS	Prospective , interventional case series .
METHODS	Twenty-three central RVO ( CRVO ) and 17 branch RVO ( BRVO ) subjects with edema despite prior anti-vascular endothelial growth factor ( VEGF ) treatment had aqueous taps at baseline and 4 and 16 weeks after dexamethasone implant .
METHODS	Best-corrected visual acuity ( BCVA ) and center subfield thickness were measured every 4 weeks .
METHODS	Aqueous vasoactive protein levels were measured by protein array or enzyme-linked immunosorbent assay .
RESULTS	Thirty-two vasoactive proteins were detected in aqueous in untreated eyes with macular edema due to RVO .
RESULTS	Reduction in excess foveal thickness after dexamethasone implant correlated with reduction in persephin and pentraxin 3 ( Pearson correlation coefficients = 0.682 and 0.638 , P = .014 and P = .003 ) .
RESULTS	Other protein changes differed among RVO patients as edema decreased , but 50 % of patients showed reductions in hepatocyte growth factor , endocrine gland VEGF , insulin-like growth factor binding proteins , or endostatin by 30 % .
RESULTS	Enzyme-linked immunosorbent assay in 18 eyes ( 12 CRVO , 6 BRVO ) showed baseline levels of hepatocyte growth factor and VEGF of 168.2 20.1 pg/mL and 78.7 10.0 pg/mL , and each was reduced in 12 eyes after dexamethasone implant .
CONCLUSIONS	Dexamethasone implants reduce several pro-permeability proteins providing a multitargeted approach in RVO .
CONCLUSIONS	No single protein in addition to VEGF can be implicated as a contributor in all patients .
CONCLUSIONS	Candidates for contribution to chronic edema in subgroups of patients that deserve further study include persephin , hepatocyte growth factor , and endocrine gland VEGF .

###24612095
BACKGROUND	To compare the efficiency of dexamethasone implants to bevacizumab injections in macular oedema secondary to central retinal vein occlusion .
METHODS	Randomized clinical trial at Cairo University Hospitals .
METHODS	Sixty eyes of 60 newly diagnosed patients with macular oedema secondary to central retinal vein occlusion with best corrected visual acuity 0.3 logMAR ( 6/12 ) to counting fingers , no evidence of retinal ischaemia and/or neovascularization on fluorescein angiography and central subfield thickness 300m on ocular coherence tomography .
METHODS	Patients were randomly assigned ( 30 eyes each group ) to either intravitreal dexamethasone implant or bevacizumab injections repeated whenever needed .
METHODS	Best corrected visual acuity and ocular coherence tomography were done at baseline and monthly for 6 months .
METHODS	Comparing best corrected visual acuity and central foveal subfield thickness between both groups during the 6-month period .
RESULTS	There was no significant difference in best corrected visual acuity between the two groups during the 6 months ( P-values > 0.05 ) .
RESULTS	The bevacizumab group had a statistically significant thinner central subfield thickness at 1 month ( P-value 0.006 ) and no statistically significant difference for the rest of the 6 months ( P-values > 0.05 ) .
RESULTS	There was a statistically significant higher intraocular pressure for dexamethasone implant group ( compared with bevacizumab ) at 3-6 months ( P-values < 0.05 ) , respectively .
CONCLUSIONS	Both drugs provided effective best corrected visual acuity improvements and central subfield thickness reductions that showed no statistically significant difference between the two groups .

###24874591
OBJECTIVE	To evaluate the effects of vildagliptin compared to glimepiride on glycemic control , insulin resistance and post-prandial lipemia .
METHODS	167 type 2 diabetic patients , not adequately controlled by metformin , were randomized to vildagliptin 50 mg twice a day or glimepiride 2 mg three times a day for 6 months , in a double blind , randomized clinical trial .
METHODS	We evaluated : body mass index ( BMI ) , glycemic control , fasting plasma insulin ( FPI ) , homeostasis model assessment insulin resistance index ( HOMA-IR ) , fasting plasma proinsulin ( FPPr ) , glucagon , lipid profile , resistin , retinol binding protein-4 ( RBP-4 ) , visfatin and vaspin .
METHODS	Furthermore , at the randomization and at the end of the study all patients underwent an euglycemic hyperinsulinemic clamp to evaluate M value and an oral fat load .
RESULTS	Despite a similar decrease of glycated hemoglobin , there were an increase of body weight with glimepiride + metformin and a decrease with vildagliptin + metformin .
RESULTS	Fasting plasma insulin increased with glimepiride + metformin , while it did not change with vildagliptin + metformin .
RESULTS	Vildagliptin + metformin improved lipid profile .
RESULTS	Regarding insulin sensitivity , vildagliptin + metformin increased M value .
RESULTS	Resistin , RBP-4 , vaspin and visfatin were decreased by vildagliptin + metformin , but in group to group comparison , only vaspin reduction resulted statistically significant .
RESULTS	Vildagliptin + metformin reduced post-prandial lipemia and insulinemia compared to glimepiride + metformin .
CONCLUSIONS	Vildagliptin , in addition to metformin , was more effective than glimepiride + metformin in reducing insulin resistance and post-prandial lipemia .

###24287218
OBJECTIVE	Does static stretch positioning combined with simultaneous neuromuscular electrical stimulation ( NMES ) in the subacute phase after stroke have beneficial effects on basic arm body functions and activities ?
METHODS	Multicentre randomised trial with concealed allocation , assessor blinding , and intention-to-treat analysis .
METHODS	Forty-six people in the subacute phase after stroke with severe arm motor deficits ( initial Fugl-Meyer Assessment arm score 18 ) .
METHODS	In addition to conventional stroke rehabilitation , participants in the experimental group received arm stretch positioning combined with motor amplitude NMES for two 45-minute sessions a day , five days a week , for eight weeks .
METHODS	Control participants received sham arm positioning ( ie , no stretch ) and sham NMES ( ie , transcutaneous electrical nerve stimulation with no motor effect ) to the forearm only , at a similar frequency and duration .
METHODS	The primary outcome measures were passive range of arm motion and the presence of pain in the hemiplegic shoulder .
METHODS	Secondary outcome measures were severity of shoulder pain , restrictions in performance of activities of daily living , hypertonia , spasticity , motor control and shoulder subluxation .
METHODS	Outcomes were assessed at baseline , mid-treatment , at the end of the treatment period ( 8 weeks ) and at follow-up ( 20 weeks ) .
RESULTS	Multilevel regression analysis showed no significant group effects nor significant time group interactions on any of the passive range of arm motions .
RESULTS	The relative risk of shoulder pain in the experimental group was non-significant at 1.44 ( 95 % CI 0.80 to 2.62 ) .
CONCLUSIONS	In people with poor arm motor control in the subacute phase after stroke , static stretch positioning combined with simultaneous NMES has no statistically significant effects on range of motion , shoulder pain , basic arm function , or activities of daily living .
BACKGROUND	NTR1748 .

###25771388
OBJECTIVE	To evaluate the efficacy and safety of omega-3 fatty acid supplementation in children with nonalcoholic fatty liver disease ( NAFLD ) .
METHODS	Overweight/obese children with NAFLD ( n = 76 ; median age , 13 years ; IQR , 11.1-15 .2 years ) were eligible to participate in the study .
METHODS	The diagnosis of NAFLD was based on elevated alanine aminotransferase ( ALT ) to 30 % of the upper limit of normal ( ULN ) and liver hyperechogenicity on ultrasound .
METHODS	Patients were randomized to receive omega-3 fatty acids ( docosahexaenoic acid and eicosapentaenoic acid , 450-1300 mg/day ) or placebo ( omega-6 sunflower oil ) .
METHODS	The primary outcome was the number of patients who demonstrated decreased ALT activity by 0.3 times the ULN .
METHODS	Secondary outcomes included alterations in liver function tests , liver hyperechogenicity , insulin resistance , and other metabolic markers after 6 months of intervention .
RESULTS	Out of 76 enrolled patients , 64 completed the trial and were analyzed .
RESULTS	After 6 months , we found no significant differences between the omega-3 and placebo groups in the number of patients with decreased ALT by 0.3 times the ULN ( 24 vs 23 ) or in median ( IQR ) ALT activity ( 48.5 [ 31-62 ] U/L vs 39 [ 27-55 ] U/L ) , liver hyperechogenicity , insulin resistance , or serum lipid levels .
RESULTS	However , patients in the omega-3 group had lower levels of aspartate aminotransferase ( 28 [ 25-36 ] U/L vs 39 [ 27-55 ] U/L ; P = .04 ) and gamma-glutamyl transpeptidase ( 26 [ 17.5-36 .5 ] U/L vs 35 [ 22-52 ] U/L ; P = .04 ) , and significantly higher levels of adiponectin .
CONCLUSIONS	Omega-3 fatty acid supplementation did not increase the number of patients with decreased ALT levels and it did not affect liver steatosis on ultrasound , but it improved aspartate aminotransferase and gamma-glutamyl transpeptidase levels in children with NAFLD compared with placebo .
BACKGROUND	Registered with ClinicalTrials.gov : NCT01547910 .

###24549933
OBJECTIVE	Rivastigmine displays dose-dependent efficacy on cognition in patients with Alzheimer 's disease ( AD ) , as measured by the Alzheimer 's Disease Assessment Scale-cognitive subscale ( ADAS-cog ) .
OBJECTIVE	Subanalysis of the OPTIMA ( OPtimising Transdermal Exelon In Mild-to-moderate Alzheimer 's disease ) study aimed to define ADAS-cog domains by factor analysis of individual items .
OBJECTIVE	Efficacy of 13.3 mg/24 h versus 9.5 mg/24 h rivastigmine patch on individual items and newly derived domains was assessed .
METHODS	OPTIMA was a 48-week , double-blind ( DB ) study in patients with mild-to-moderate AD .
METHODS	Patients meeting pre-defined decline criteria during open-label treatment with 9.5 mg/24 h patch were randomized in the DB phase to 13.3 mg/24 h ( n = 280 ) or 9.5 mg/24 h ( n = 287 ) patch .
METHODS	ADAS-cog change from baseline was a co-primary outcome measure .
METHODS	Factor analysis categorized ADAS-cog items into newly derived domains .
METHODS	Change from DB-baseline was calculated for domains and individual items .
RESULTS	Numerically , less decline was displayed with 13.3 mg/24 h versus 9.5 mg/24 h patch in the total ADAS-cog score at all time points ( significant at Week 24 , p = 0.027 ) .
RESULTS	Factor analysis identified two domains : memory and language .
RESULTS	Significantly , less decline was observed on the memory domain with 13.3 mg/24 h versus 9.5 mg/24 h patch at Weeks 12 , 24 , and 48 ( p < 0.05 ; observed cases ) .
RESULTS	Three items ( following commands , orientation , and word recognition ) displayed numerically less decline with 13.3 mg/24 h versus 9.5 mg/24 h patch at all time points .
RESULTS	No significant between-group differences were observed on the language domain .
CONCLUSIONS	Results suggest that the greater cognitive efficacy of 13.3 mg/24 h versus 9.5 mg/24 h rivastigmine patch is driven primarily by effects on memory , particularly in the areas of following commands , orientation , and word recognition .

###24942849
BACKGROUND	Automated bolus delivery has recently been shown to reduce local anesthetic consumption and improve analgesia , compared with continuous infusion , in continuous sciatic and epidural block .
BACKGROUND	However , there are few data on the influence of local anesthetic delivery method on local anesthetic consumption following interscalene blockade .
BACKGROUND	This randomized , double-blind trial was designed to determine whether hourly automated perineural boluses ( 4 mL ) of local anesthesia delivered with patient-controlled pro re nata ( PRN , on demand ) boluses would result in a reduction in total local anesthesia consumption during continuous interscalene blockade after shoulder surgery compared with continuous perineural infusion ( 4 mL/h ) plus patient-controlled PRN boluses .
METHODS	One hundred one patients undergoing major shoulder surgery under general anesthesia with ultrasound-guided continuous interscalene block were randomly assigned to receive 0.2 % ropivacaine via interscalene end-hole catheter either by continuous infusion 4 mL/h ( n = 50 ) or as automated bolus 4 mL/h ( n = 51 ) .
METHODS	Both delivery methods were combined with 5 mL PRN boluses of 0.2 % ropivacaine with a lockout time of 30 minutes .
METHODS	Postoperative number of PRN boluses , 24 - and 48-hour local anesthetic consumption , pain scores , rescue analgesia ( morphine ) , and adverse events were recorded .
RESULTS	There were no significant differences in either the number of PRN ropivacaine boluses or total 48 hour local anesthetic consumption between the groups ( 18.5 [ 11-25 .2 ] PRN boluses in the continuous infusion group vs 17 [ 8.5-29 ] PRN boluses in the automated bolus group ) .
RESULTS	Postoperative pain was similar in both groups ; on day 2 , the median average pain score was 4 ( 2-6 ) in the continuous infusion group versus 3 ( 2-5 ) in the automated bolus group ( P = 0.54 ) .
RESULTS	Nor were any statistically significant intergroup differences observed with respect to morphine rescue , incidence of adverse events , or patient satisfaction .
CONCLUSIONS	In continuous interscalene blockade under ultrasound guidance after shoulder surgery , automated boluses of local anesthetic combined with PRN boluses did not provide any reduction in local anesthetic consumption or rescue analgesia , compared with continuous infusion combined with PRN boluses .

###24266796
OBJECTIVE	The current study aimed to investigate the impact of brief mindfulness training on the performance of a sample of patients with TBI in an over-selectivity task .
METHODS	Twenty-four patients who had suffered TBI and reported problems with focused or sustained attention .
METHODS	The study was a between-subjects design ( mindfulness intervention vs control ) with difference between number of most and least chosen stimulus selections on an over-selectivity task as the dependent measure .
RESULTS	The results of this study indicated that stimulus over-selectivity was present in a group of patients with TBI .
RESULTS	However , the level of emergent over-selectivity was significantly reduced by a mindfulness induction when compared to a no - intervention control group .
CONCLUSIONS	The findings are discussed in terms of the efficacy of mindfulness training in reducing TBI-related cognitive deficits .

###24421302
OBJECTIVE	Type 2 diabetes mellitus ( T2DM ) management requires continuous treatment intensification due to progressive decline in - cell function in insulin resistant individuals .
OBJECTIVE	Initial combination therapy of a dipeptidyl peptidase ( DPP ) -4 inhibitor with a thiazolidinedione ( TZD ) may be rational .
OBJECTIVE	We assessed the effects of the DPP4 inhibitor alogliptin ( ALO ) combined with the TZD pioglitazone ( PIO ) , vs ALO monotherapy or placebo ( PBO ) , on - cell function and glycemic control in T2DM .
METHODS	A 16-week , two-center , randomized , double-blind , PBO-controlled , parallel-arm intervention study in 71 patients with well-controlled T2DM ( age 59.16.3 years ; A1C 6.70.1 % ) treated with metformin , sulfonylurea , or glinide monotherapy was conducted .
METHODS	Patients were treated with combined ALO 25mg and PIO 30mg daily or ALO 25mg daily monotherapy or PBO .
METHODS	Main outcome measures included change in A1C and fasting plasma glucose ( FPG ) from baseline to week 16 .
METHODS	In addition , change in - cell function parameters obtained from standardized meal tests at baseline and at week 16 was measured .
RESULTS	ALO/PIO and ALO decreased A1C from baseline by 0.90.1 and 0.40.2 % respectively ( both P < 0.001 vs PBO ) .
RESULTS	FPG was decreased to a greater extent by ALO/PIO compared with ALO monotherapy ( P < 0.01 ) .
RESULTS	ALO/PIO treatment improved - cell glucose sensitivity ( vs PBO ; P < 0.001 ) and fasting secretory tone ( vs PBO ; P = 0.001 ) , while ALO monotherapy did not change - cell function parameters .
RESULTS	All treatments were well tolerated .
CONCLUSIONS	Short-term treatment with ALO/PIO or ALO improved glycemic control in well-controlled T2DM patients , but only combined ALO/PIO improved - cell function .
CONCLUSIONS	These data support that initial combination therapy with a DPP4 inhibitor and TZD to address multiple core defects in T2DM may be a sensible approach .

###24467781
BACKGROUND	The aim of this study was to evaluate the efficacy of a group Cognitive Behavioural Therapy ( CBT ) treatment for depression and anxiety in Parkinson 's disease ( PD ) .
METHODS	A waitlist-controlled trial design was used .
METHODS	Eighteen adults with PD and a comorbid DSM-IV-TR diagnosis of depression and/or anxiety were randomised to either Intervention ( 8-week group CBT treatment ) or Waitlist ( 8-week clinical monitoring preceding treatment ) .
METHODS	The Depression , Anxiety , Stress Scale-21 ( DASS-21 ) was the primary outcome .
METHODS	Assessments were completed at Time 1 ( pretreatment ) , Time 2 ( posttreatment/post-waitlist ) and 1-month and 6-month follow-ups .
RESULTS	At Time 2 , participants who received CBT reported greater reductions in depression ( M ( change ) = -2.45 ) than Waitlist participants ( M ( change ) = .29 ) and this effect was large , d = 1.12 , p = .011 .
RESULTS	Large secondary effects on anxiety were also observed for CBT participants , d = .89 , p = .025 .
RESULTS	All treatment gains were maintained and continued to improve during the follow-up period .
RESULTS	At 6-month follow-up , significant and large effects were observed for both depression ( d = 2.07 ) and anxiety ( d = 2.26 ) .
CONCLUSIONS	Group CBT appears to be an efficacious treatment approach for depression and anxiety in PD however further controlled trials with larger numbers of participants are required .
BACKGROUND	Australian New Zealand Clinical Trials Registry ( Trial ID : ACTRN12610000455066 ) .

###24499405
BACKGROUND	Longitudinal studies have shown that objectively measured walking behaviour is subject to seasonal variation , with people walking more in summer compared to winter .
BACKGROUND	Seasonality therefore may have the potential to bias the results of randomised controlled trials if there are not adequate statistical or design controls .
BACKGROUND	Despite this there are no studies that assess the impact of seasonality on walking behaviour in a randomised controlled trial , to quantify the extent of such bias .
BACKGROUND	Further there have been no studies assessing how season impacts on the psychological predictors of walking behaviour to date .
BACKGROUND	The aim of the present study was to assess seasonal differences in a ) objective walking behaviour and b ) Theory of Planned Behaviour ( TPB ) variables during a randomised controlled trial of an intervention to promote walking .
METHODS	315 patients were recruited to a two-arm cluster randomised controlled trial of an intervention to promote walking in primary care .
METHODS	A series of repeated measures ANCOVAs were conducted to examine the effect of season on pedometer measures of walking behaviour and TPB measures , assessed immediately post-intervention and six months later .
METHODS	Hierarchical regression analyses were conducted to assess whether season moderated the prediction of intention and behaviour by TPB measures .
RESULTS	There were no significant differences in time spent walking in spring/summer compared to autumn/winter .
RESULTS	There was no significant seasonal variation in most TPB variables , although the belief that there will be good weather was significantly higher in spring/summer ( F = 19.46 , p < .001 ) .
RESULTS	Season did not significantly predict intention or objective walking behaviour , or moderate the effects of TPB variables on intention or behaviour .
CONCLUSIONS	Seasonality does not influence objectively measured walking behaviour or psychological variables during a randomised controlled trial .
CONCLUSIONS	Consequently physical activity behaviour outcomes in trials will not be biased by the season in which they are measured .
CONCLUSIONS	Previous studies may have overestimated the extent of seasonality effects by selecting the most extreme summer and winter months to assess PA. .
CONCLUSIONS	In addition , participants recruited to behaviour change interventions might have higher levels of motivation to change and are less affected by seasonal barriers .
BACKGROUND	Current Controlled Trials ISRCTN95932902 .

###24401626
OBJECTIVE	To evaluate the efficacy of high-intensity focused ultrasound ( HIFU ) and cortical hormone in the treatment of non-neoplastic epithelial disorders of vulva .
METHODS	A total of 268 cases with pathologically diagnosed non-neoplastic epithelial disorders of vulva were randomly allocated into two groups of high-intensity focused ultrasound ( HIFU ) ( n = 119 ) and cortical hormone ( n = 124 ) .
METHODS	And 25 cases became lost to follow-ups .
METHODS	Their signs , symptoms and quality-of-life were assessed before treatment , 1 month post-treatment and 3 months post-treatment .
METHODS	And the relationship was analyzed between pathologic type , age , course and efficacies .
RESULTS	Their signs , symptoms and quality-of-life improved in both groups after 1 and 3 month .
RESULTS	Compared with drug therapy , HIFU showed superior results in lesion amelioration at 1 month with significantly statistical difference and so did lesion amelioration and therapeutic effect at 3 month .
RESULTS	And the efficacy of HIFU was better in those with > 10-year disease course and pathologically diagnosed lichen sclerosus in 3 months .
CONCLUSIONS	HIFU is both safe and effective in the treatment of non-neoplastic epithelial disorders of vulva .

###24398576
OBJECTIVE	The aim of this study was to investigate the acute effects of whole-body vibration on the motor function of patients with stroke .
METHODS	The present investigation was a randomized clinical trial studying 43 individuals with hemiparesis after stroke , with 33 subjects allocated to the intervention group and 10 subjects allocated to the control group .
METHODS	The intervention group was subjected to one session of vibration therapy ( frequency of 50 Hz and amplitude of 2 mm ) comprising four 1-min series with 1-min rest intervals between series in three body positions : bipedal stances with the knees flexed to 30 degrees and 90 degrees and a unipedal stance on the paretic limb .
METHODS	The analytical tests were as follows : simultaneous electromyography of the affected and unaffected tibialis anterior and rectus femoris muscles bilaterally in voluntary isometric contraction ; the Six-Minute Walk Test ; the Stair-Climb Test ; and the Timed Get-Up-and-Go Test .
METHODS	The data were analyzed by independent and paired t tests and by analysis of covariance .
RESULTS	There was no evidence of effects on the group and time interaction relative to variables affected side rectus femoris , unaffected side rectus femoris , affected side tibialis anterior , unaffected side tibialis anterior , and the Stair-Climb Test ( P > 0.05 ) .
RESULTS	There was evidence of effects on the group interaction relative to variables Six-Minute Walk Test and Timed Get-Up-and-Go Test ( P < 0.05 ) .
CONCLUSIONS	Whole-body vibration contributed little to improve the functional levels of stroke patients .

###24836125
BACKGROUND	Retrospective studies have shown that statins decrease the rate and severity of exacerbations , the rate of hospitalization , and mortality in chronic obstructive pulmonary disease ( COPD ) .
BACKGROUND	We prospectively studied the efficacy of simvastatin in preventing exacerbations in a large , multicenter , randomized trial .
METHODS	We designed the Prospective Randomized Placebo-Controlled Trial of Simvastatin in the Prevention of COPD Exacerbations ( STATCOPE ) as a randomized , controlled trial of simvastatin ( at a daily dose of 40 mg ) versus placebo , with annual exacerbation rates as the primary outcome .
METHODS	Patients were eligible if they were 40 to 80 years of age , had COPD ( defined by a forced expiratory volume in 1 second [ FEV1 ] of less than 80 % and a ratio of FEV1 to forced vital capacity of less than 70 % ) , and had a smoking history of 10 or more pack-years , were receiving supplemental oxygen or treatment with glucocorticoids or antibiotic agents , or had had an emergency department visit or hospitalization for COPD within the past year .
METHODS	Patients with diabetes or cardiovascular disease and those who were taking statins or who required statins on the basis of Adult Treatment Panel III criteria were excluded .
METHODS	Participants were treated from 12 to 36 months at 45 centers .
RESULTS	A total of 885 participants with COPD were enrolled for approximately 641 days ; 44 % of the patients were women .
RESULTS	The patients had a mean ( SD ) age of 62.28.4 years , an FEV1 that was 41.617.7 % of the predicted value , and a smoking history of 50.627.4 pack-years .
RESULTS	At the time of study closeout , the low-density lipoprotein cholesterol levels were lower in the simvastatin-treated patients than in those who received placebo .
RESULTS	The mean number of exacerbations per person-year was similar in the simvastatin and placebo groups : 1.361.61 exacerbations and 1.391.73 exacerbations , respectively ( P = 0.54 ) .
RESULTS	The median number of days to the first exacerbation was also similar : 223 days ( 95 % confidence interval [ CI ] , 195 to 275 ) and 231 days ( 95 % CI , 193 to 303 ) , respectively ( P = 0.34 ) .
RESULTS	The number of nonfatal serious adverse events per person-year was similar , as well : 0.63 events with simvastatin and 0.62 events with placebo .
RESULTS	There were 30 deaths in the placebo group and 28 in the simvastatin group ( P = 0.89 ) .
CONCLUSIONS	Simvastatin at a daily dose of 40 mg did not affect exacerbation rates or the time to a first exacerbation in patients with COPD who were at high risk for exacerbations .
CONCLUSIONS	( Funded by the National Heart , Lung , and Blood Institute and the Canadian Institutes of Health Research ; STATCOPE ClinicalTrials.gov number , NCT01061671 . )

###24456217
BACKGROUND	The Japan Atherosclerosis Society 's 2007 Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases ( JAS2007GL ) advocate reducing LDL cholesterol ( LDL-C ) to target levels in patients with dyslipidemia , but achievement rates are frequently unsatisfactory even in the presence of lipid-lowering therapy .
BACKGROUND	This multicenter , open-label , randomized , parallel-group study compared the efficacy of rosuvastatin and atorvastatin on JAS2007GL LDL-C goals in Japanese patients not achieving their target goal with atorvastatin treatment .
METHODS	The study involved 20 clinical institutes in Japan ( Kishiwada Atherosclerosis Prevention Study [ KAPS ] Group ) .
METHODS	Patients with category II or III risk of coronary artery disease ( CAD ) , or those with a history of CAD ( secondary prevention ) , who had not achieved their JAS2007GL LDL-C goals during treatment with atorvastatin for at least 4 weeks were switched either to rosuvastatin 5 mg/day ( from atorvastatin 10 mg/day ) or rosuvastatin 10 mg/day ( from atorvastatin 20 mg/day ) ( n = 75 ) or continued to receive atorvastatin ( n = 77 ) .
METHODS	The primary endpoint was achievement of LDL-C goals at 3 months .
METHODS	The main secondary endpoint was achievement of LDL-C goal + high-sensitivity C-reactive protein level < 1.0 mg/L at 3 months .
RESULTS	Achievement rates for the primary endpoint were 49.3 % in the rosuvastatin group and 31.7 % in the atorvastatin group ( P = 0.022 ) .
RESULTS	Achievement rates for the main secondary endpoint were 40.0 % in the rosuvastatin group and 20.8 % in the atorvastatin group ( P = 0.010 ) .
RESULTS	Rosuvastatin and atorvastatin were both well tolerated in this study .
CONCLUSIONS	Rosuvastatin is a useful treatment option for Japanese patients who are not achieving their JAS2007GL LDL-C goal with atorvastatin .

###24779438
BACKGROUND	Many cancer patients have problems performing activities of daily living ( ADL ) .
BACKGROUND	A randomised controlled trial was designed to examine the effects of an ADL intervention in addition to standard treatment and care in a hospital setting .
BACKGROUND	The objective of this article was to present the study and to analyse the feasibility of the recruitment process and the intervention .
METHODS	Adult disabled cancer patients at Nstved Hospital in Denmark were enrolled between 1 March 2010 and 30 June 2011 and randomised into an ADL intervention or to a control group .
METHODS	The intervention was performed by occupational therapists .
METHODS	The feasibility of the recruitment was analysed with regard to success in achieving the estimated number of participants and identification of barriers , and feasibility of the intervention was based on calculations of patient attendance and patient acceptability .
METHODS	The primary outcome of the randomised controlled trial was patients ' health-related quality of life 2 and 8weeks after baseline .
RESULTS	A total of 118 disabled cancer patients were enrolled in the study over a time span of 16months .
RESULTS	Very few meetings between occupational therapist and patient were cancelled .
RESULTS	Time spent on the intervention varied considerably , but for the majority of patients , time consumption was between 1-3 hours .
CONCLUSIONS	Despite difficulties with recruitment , participation was considered feasible and the intervention was accepted among patients .
CONCLUSIONS	Missing data in the follow-up period were mostly due to death among participants .
CONCLUSIONS	Very few participants declined to complete questionnaires during follow-up .

###24758565
BACKGROUND	Glucocorticoids ( GCS ) remain one of the mainstay treatments in the management of ulcerative colitis ( UC ) but up to a third of patients will ultimately fail to respond and progress to a more severe and difficult to manage disease state .
BACKGROUND	Previous clinical studies suggest that the Toll-Like Receptor 9 ( TLR9 ) agonist DIMS0150 not only induces production of key anti-inflammatory cytokines as IL-10 but interestingly also enhances steroid sensitivity in steroid refractory UC patients .
BACKGROUND	We investigated , in the context of a clinical study , whether a pre-selection of steroid response genes could identify steroid refractory UC subjects most likely to respond to DIMS0150 treatment .
METHODS	In a non-interventional pilot study , blood from steroid refractory UC patients and healthy volunteers was taken and thirty-four previously described steroid response genes were analysed by real time PCR analysis .
METHODS	To establish clinical utility of the identified biomarkers , a placebo controlled , randomized , double blinded study in active steroid dependent and steroid resistant UC patients on concomitant steroid therapies was used ( EudraCT number : 2006-001846-15 ) .
RESULTS	We identified three potential biomarkers CD163 , TSP-1 and IL-1RII whose response to steroids was significantly enhanced when DIMS0150 was applied .
RESULTS	Thirty-four subjects were randomized to receive a single rectal administration of placebo or 30mg of DIMS0150 .
RESULTS	Blood derived PBMCs were obtained prior to dosing and assayed for evidence of a steroid enhancing effect following steroid incubation in the presence of DIMS0150 .
RESULTS	Comparison to established steroid sensitivity marker IL-6 confirmed that clinical responders are steroid refractory UC patients .
RESULTS	Upon study completion and un-blinding , the biomarker assay correctly predicted a clinical response in over 90 % of the patients .
CONCLUSIONS	Using specific steroid response biomarkers , GCS refractory UC patients most likely to benefit from DIMS0150 treatment could be identified and illustrates the usefulness of a personalized treatment approach .

###25464418
BACKGROUND	The elderly ( 75years ) constitute a high-risk subset of patients who continue to have a poorer prognosis than non-elderly ( < 75years ) .
BACKGROUND	Whether the effects of everolimus-eluting stent ( EES ) in ST-segment elevation myocardial infarction ( STEMI ) are independent of age has not been reported .
BACKGROUND	We investigated the outcomes following primary PCI ( PPCI ) with bare-metal stent ( BMS ) or EES in elderly vs. non-elderly STEMI patients .
METHODS	The EXAMINATION trial randomized 1498 STEMI patients to BMS or EES .
METHODS	The primary patient-oriented endpoint ( POCE ) was the combined of all-cause death , any-recurrent myocardial infarction ( MI ) and any-revascularization at 1-year .
METHODS	The secondary endpoint included the device-oriented combined ( DOCE ) of cardiac death , target-vessel MI and target-lesion revascularization .
METHODS	These endpoints and their components were compared between elderly and non-elderly .
RESULTS	Among patients enrolled in the trial , 245 ( 16.3 % ) were elderly , allocated to BMS ( n = 132 ) or EES ( n = 113 ) , while the remaining 1253 ( 83.7 % ) were non-elderly , allocated to BMS ( n = 615 ) or EES ( n = 638 ) .
RESULTS	At 1-year , both the POCE and DOCE were observed more frequently in elderly vs. non-elderly group ( 24.5 % vs. 10.5 % , p < 0.001 and 15.9 % vs. 5.1 % , p < 0.001 ) .
RESULTS	Whereas in non-elderly , both POCE and DOCE were lower in EES vs. BMS ( 12.4 % vs. 8.8 % , p = 0.03 and 6.7 % vs. 3.6 % , p = 0.01 ) , no differences were found in elderly , with a tendency for interaction between age and stent type for POCE ( p = 0.05 ) .
RESULTS	On multivariate analysis age 75 years was an independent predictor of POCE ( HR 2.19 [ 95 % CI 1.59-3 .01 ] , p < 0.0001 ) and DOCE ( HR 2.42 [ 95 % CI 1.60-3 .7 ] , p < 0.001 ) at 1-year .
CONCLUSIONS	In STEMI patients undergoing PPCI , advanced age ( 75 years ) is associated with worse outcomes .
CONCLUSIONS	The beneficial effects of EES over BMS tended to be age-dependent .

###24362908
OBJECTIVE	This study investigated the efficacy and safety of cryotherapy , in the form of frozen gel gloves , in relation to docetaxel-induced hand and fingernail toxicities .
METHODS	After piloting with 21 patients , a consecutive series sample of patients ( n = 53 ) prescribed docetaxel every 3 weeks , for a minimum of three cycles , was enrolled in this randomised control trial .
METHODS	Participants acted as their own control , with the frozen gel glove worn on one randomised hand for 15 min prior to infusion , for the duration of the infusion , and for 15 min of after completion of treatment .
METHODS	Hand and nail toxicities were evaluated by two blinded assessors according to CTCAE.v4 criteria .
METHODS	To assess the potential for cross-infection of multi-use gloves , microbial culture and sensitivity swabs were taken of each glove at every tenth use .
RESULTS	Of the 53 participants enrolled in the main study , 21 provided evaluable data .
RESULTS	There was a 60 % withdrawal rate due to patient discomfort with the intervention .
RESULTS	The mean incidence and severity of toxicities in all evaluable cycles in control and intervention hands respectively were erythroderma grade 1 ( 5/5 % ) , nail discolouration grade 1 ( 81/67 % ) , nail loss grade 1 ( 19/19 % ) and nail ridging grade 1 ( 57/57 % ) .
RESULTS	No significant differences were determined between hand conditions in terms of time to event , nor in terms of toxicity in gloved and non-gloved hands .
CONCLUSIONS	While cryotherapy in the form of frozen gloves for the cutaneous toxicities associated with docetaxel is safe , its limited efficacy , patient discomfort and some logistical issues preclude its use in our clinical setting .

###25262271
BACKGROUND	Elevated resting pulse rate ( RPR ) is a well-recognized risk factor for adverse outcomes .
BACKGROUND	Epidemiological evidence supports the beneficial effects of regular exercise for lowering RPR , but studies are mainly confined to persons younger than 65 years .
BACKGROUND	We set out to evaluate the utility of a physical activity ( PA ) intervention for slowing RPR among older adults .
METHODS	A total of 424 seniors ( ages 70-89 years ) were randomized to a moderate intensity PA intervention or an education-based `` successful aging '' health program .
METHODS	Resting pulse rate was assessed at baseline , 6 months , and 12 months .
METHODS	Longitudinal differences in RPR were evaluated between treatment groups using generalized estimating equation models , reporting unstandardized coefficients with robust SEs .
RESULTS	Increased frequency and duration of aerobic training were observed for the PA group at 6 and 12 months as compared with the successful aging group ( P < .001 ) .
RESULTS	In both groups , RPR remained unchanged over the course of the 12-month study period ( P = .67 ) .
RESULTS	No significant improvement was observed ( [ SE ] = 0.58 [ 0.88 ] ; P = .51 ) for RPR when treatment groups were compared using the generalized estimating equation method .
RESULTS	Comparable results were found after omitting participants with a pacemaker , cardiac arrhythmia , or who were receiving - blockers .
CONCLUSIONS	Twelve months of moderate intensity aerobic training did not improve RPR among older adults .
CONCLUSIONS	Additional studies are needed to determine whether PA of longer duration and/or greater intensity can slow RPR in older persons .

###24223740
METHODS	Oral ibuprofen has demonstrated good effects on symptomatic patent ductus arteriosus ( PDA ) but with many contraindications and potential side-effects .
METHODS	In the past two years , oral paracetamol administration to several preterm infants with PDA has been reported .
METHODS	Here , a randomized , non-blinded , parallel-controlled and non-inferiority trial was designed to evaluate the efficacy and safety profiles of oral paracetamol to those of standard ibuprofen for PDA closure in premature infants .
METHODS	One hundred and sixty infants ( gestational age 34 weeks ) with echocardiographically confirmed PDA were randomly assigned to receive either oral paracetamol ( n = 80 ) or ibuprofen ( n = 80 ) .
METHODS	After the initial treatment course in both groups , the need for a second course was determined by echocardiographic evaluation .
METHODS	The main outcome was rate of ductal closure , and secondary outcomes were adverse effects and complications .
RESULTS	The ductus was closed in 65 ( 81.2 % ) infants of the paracetamol group compared with 63 ( 78.8 % ) of the ibuprofen group .
RESULTS	The 95 % confidence interval of the difference between these groups was [ -0.080,0.128 ] , demonstrating that the effectiveness of paracetamol treatment was not inferior to that of ibuprofen .
RESULTS	In fact , the incidence of hyperbilirubinemia or gastrointestinal bleeding in the paracetamol group was significantly lower than that of the ibuprofen group .
RESULTS	No significant differences in other clinical side effects or complications were noted .
CONCLUSIONS	This comparison of drug efficacy and safety profiles in premature infants with PDA revealed that oral paracetamol was comparable to ibuprofen in terms of the rate of ductal closure and even showed a decreased risk of hyperbilirubinemia or gastrointestinal bleeding .
CONCLUSIONS	Therefore , paracetamol may be accepted as a first-line drug treatment for PDA in preterm infants .
BACKGROUND	ChiCTR.org ChiCTR-TRC-12002177 .

###24576893
BACKGROUND	Hyperkalemia is a common medical emergency that may result in serious cardiac arrhythmias .
BACKGROUND	Standard therapy with insulin plus glucose reliably lowers the serum potassium concentration ( [ K ( + ) ] ) but carries the risk of hypoglycemia .
BACKGROUND	This study examined whether an intravenous glucose-only bolus lowers serum [ K ( + ) ] in stable , nondiabetic , hyperkalemic patients and compared this intervention with insulin-plus-glucose therapy .
METHODS	A randomized , crossover study was conducted in 10 chronic hemodialysis patients who were prone to hyperkalemia .
METHODS	Administration of 10 units of insulin with 100 ml of 50 % glucose ( 50 g ) was compared with the administration of 100 ml of 50 % glucose only .
METHODS	Serum [ K ( + ) ] was measured up to 60 min .
METHODS	Patients were monitored for hypoglycemia and EKG changes .
RESULTS	Baseline serum [ K ( + ) ] was 6.01 0.87 and 6.23 1.20 mmol/l in the insulin and glucose-only groups , respectively ( p = 0.45 ) .
RESULTS	At 60 min , the glucose-only group had a fall in [ K ( + ) ] of 0.50 0.31 mmol/l ( p < 0.001 ) .
RESULTS	In the insulin group , there was a fall of 0.83 0.53 mmol/l at 60 min ( p < 0.001 ) and a lower serum [ K ( + ) ] at that time compared to the glucose-only group ( 5.18 0.76 vs. 5.73 1.12 mmol/l , respectively ; p = 0.01 ) .
RESULTS	In the glucose-only group , the glucose area under the curve ( AUC ) was greater and the insulin AUC was smaller .
RESULTS	Two patients in the insulin group developed hypoglycemia .
CONCLUSIONS	Infusion of a glucose-only bolus caused a clinically significant decrease in serum [ K ( + ) ] without any episodes of hypoglycemia .

###24576858
OBJECTIVE	Variable airway function is a central feature of the asthmatic condition .
OBJECTIVE	Thus , habitually active asthmatics are certain to exercise under conditions of variable airway ( dys ) function .
OBJECTIVE	The purpose of this study was to determine the effects of variable preexercise airway function on ventilation during whole-body exercise in asthmatic adults .
METHODS	Eight mild asthmatic ( age = 26 yr ; VO2peak = 49 mLkgmin ) and nine nonasthmatic ( age = 30 yr ; VO2peak = 46 mLkgmin ) adults performed constant workrate cycling exercise to exhaustion after four separate interventions : 1 ) a control trial ( CON ) ; 2 ) inhalation of fast-acting 2-agonist ( BD ) ; 3 ) eucapnic voluntary hyperpnea challenge ( BC ) ; and 4 ) sham to the hyperpnea ( SHAM ) .
METHODS	Pulmonary function was assessed at baseline and after each intervention .
METHODS	Exercise ventilation and operating lung volumes were compared among the four exercise trials in both control and asthmatic subjects .
RESULTS	Baseline pulmonary function was significantly lower in asthmatic subjects compared with control subjects .
RESULTS	In asthmatic subjects , postintervention ( i.e. , preexercise ) forced expiratory volume 1.0 s was significantly different among the four exercise trials ( CON = 3.5 0.4 , BD = 4.1 0.4 , SHAM = 3.6 0.3 , BC = 2.8 0.3 L , P < 0.05 ) , whereas it was not different in control subjects .
RESULTS	There were no differences in exercise ventilation or operating lung volumes during exercise among the four trials either within asthmatic subjects or between control and asthmatic subjects .
CONCLUSIONS	These findings suggest that the state of airway function-whether bronchodilated or bronchoconstricted-before exercise in the mild asthmatic does not affect the exercise ventilatory response .
CONCLUSIONS	Thus , ventilatory system function in the asthmatic appears to be responsive to the acute requirement for increased airflow during whole-body exercise .

###25919841
OBJECTIVE	To comparatively analyze the efficacy , acceptability , and tolerability of various augmentation agents in adult patients with treatment-resistant depression .
METHODS	An electronic literature search of PubMed , EMBASE , the Cochrane Library , Web of Science , EBSCO , PsycINFO , EAGLE , and NTIS for trials published up to December 2013 was conducted .
METHODS	Several clinical trial registry agencies and US Food and Drug Administration reports were also reviewed .
METHODS	No language , publication date , or publication status restrictions were imposed .
METHODS	Randomized controlled trials comparing 11 augmentation agents ( aripiprazole , bupropion , buspirone , lamotrigine , lithium , methylphenidate , olanzapine , pindolol , quetiapine , risperidone , and thyroid hormone ) with each other and with placebo for adult treatment-resistant depression were included .
METHODS	The proportion of patients who responded to treatment was defined as primary efficacy , and the proportion of all-cause discontinuation and side-effects discontinuation were respectively defined as acceptability and tolerability , which were assessed with odds ratios ( ORs ) and a Bayesian random-effects model with 95 % credible intervals ( CrIs ) .
RESULTS	A total of 48 trials consisting of 6,654 participants were eligible .
RESULTS	In terms of the primary efficacy , quetiapine ( OR = 1.92 ; 95 % CrI , 1.39-3 .13 ) , aripiprazole ( OR = 1.85 ; 95 % CrI , 1.27-2 .27 ) , thyroid hormone ( OR = 1.84 ; 95 % CrI , 1.06-3 .56 ) , and lithium ( OR = 1.56 ; 95 % CrI , 1.05-2 .55 ) were significantly more effective than placebo .
RESULTS	Sensitivity analyses indicated that efficacy estimates for aripiprazole and quetiapine were more robust than those for thyroid hormone and lithium .
RESULTS	In terms of acceptability , no significant difference was found between active agents and placebo .
RESULTS	In terms of tolerability , compared to placebo , quetiapine ( OR = 3.85 ; 95 % CrI , 1.92-8 .33 ) , olanzapine ( OR = 3.36 ; 95 % CrI , 1.60-8 .61 ) , aripiprazole ( OR = 2.51 ; 95 % CrI , 1.11-7 .69 ) , and lithium ( OR = 2.30 ; 95 % CrI , 1.04-6 .03 ) were significantly less well tolerated .
CONCLUSIONS	Quetiapine and aripiprazole appear to be the most robust evidence-based options for augmentation therapy in patients with treatment-resistant depression , but clinicians should interpret these findings cautiously in light of the evidence of potential treatment-related side effects .

###25469673
BACKGROUND	As cancer survivorship increases , health care systems will be challenged to meet patient needs .
BACKGROUND	With the limited availability of clinician time and resources , novel methods of using patient-reported outcomes may improve the quality and efficiency of follow-up care in patients with breast cancer .
METHODS	The authors conducted a randomized trial in patients with TNM stage I to III breast cancer comparing standard care with SIS.NET ( System for Individualized Survivorship Care , based on patient self-reported data , with review by Nurse practitioners , targeted Education , and Triage ) , a follow-up protocol including integration of online health questionnaires at 3-month intervals and the evaluation of self-reported symptoms monitored and addressed remotely by a nurse practitioner ( NP ) .
METHODS	The primary endpoint was to quantify the time between symptom reporting and remote evaluation of symptoms .
METHODS	The secondary endpoint was to compare use of health care resources ( breast cancer-related visits , total medical appointments , and laboratory and imaging studies ) over an 18-month period .
RESULTS	A total of 102 participants were enrolled ; 2 patients were excluded due to cancer recurrence .
RESULTS	In the SIS.NET arm , 74 % of new or changed self-reported symptoms were reviewed by a NP in < 3 days .
RESULTS	SIS.NET patients reported more new or changed symptoms compared with standard care patients ( 7.36 vs 3.2 ; P = .0045 ) .
RESULTS	During the 18-month trial , there were no statistically significant differences noted between the SIS.NET and standard care arms with regard to oncology-related appointments ( mean , 4.2 vs 4.1 appointments ) , number of physician visits ( mean , 10.8 vs 9.6 visits ) , or medical tests ( mean , 5.5 vs 5 tests ) .
CONCLUSIONS	Integration of online health questionnaires with remote review by a NP facilitated symptom reporting and may provide a means of convenient symptom assessment , but it did not appear to reduce health care resource use .

###24308187
OBJECTIVE	To compare the cumulative analgesic effect of electroacupuncture ( EA ) stimulation of Sanyinjiao ( SP 6 ) , Xuanzhong ( GB 39 ) and non-acupoint for primary dysmenorrhea patients .
METHODS	A total of 200 patients with primary dysmenorrhea were randomly assigned to Sanyinjiao ( SP 6 , a dysmenorrheal-relieving related acupoint ) group , Xuanzhong ( GB 39 , an unrelated acupoint ) group , non-acupoint group and control group , with 50 cases in each group .
METHODS	The participants were administered with EA ( 2 Hz/100 Hz , 0.5-1 .6 mA ) at SP 6 , GB 39 and non-acupoint for 30 min , once daily for 3 consecutive days .
METHODS	The intensity of the pain was ranked from 0 ( no pain ) to 100 ( intolerable ) using visual analogue scale ( VAS ) and RSS ( Cox retrospective symptom scale ) severity rating scores ( RSS-COX 2 ) before and after three interventions .
RESULTS	In comparison with the control group , VAS and RSS-COX 2 scores were significantly lower in the SP 36 , GB 39 and non-acupoint groups ( P < 0.001 , P < 0.05 ) , suggesting an alleviation of the pain severity after EA treatment .
RESULTS	No significant differences were found among the three treatment groups in both VAS and RSS-COX 2 scores ( P > 0.05 ) .
CONCLUSIONS	EA stimulation of SP 6 , GB 39 and non-acupoint has a good cumulative analgesic effect in patients with primary dysmenorrhea .

###24766757
OBJECTIVE	The purpose of this study was to examine the effectiveness of a patient-provider educational intervention in reducing at-risk drinking among older adults .
METHODS	This was a cluster-randomized controlled trial of 31 primary care providers and their patients ages 60 years and older at a community-based practice with seven clinics .
METHODS	Recruitment occurred from July 2005 to August 2007 .
METHODS	Eligibility was determined by telephone and a baseline mailed survey .
METHODS	A total of 1,186 at-risk drinkers were identified by the Comorbidity Alcohol Risk Evaluation Tool .
METHODS	Follow-up patient surveys were administered at 3 , 6 , and 12 months after baseline .
METHODS	Study physicians and their patients were randomly assigned to usual care ( n = 640 patients ) versus the Project SHARE ( Senior Health and Alcohol Risk Education ) intervention ( n = 546 patients ) , which included personalized reports , educational materials , drinking diaries , physician advice during office visits , and telephone counseling delivered by a health educator .
METHODS	Main outcomes were alcohol consumption , at-risk drinking ( overall and by type ) , alcohol discussions with physicians , health care utilization , and screening and intervention costs .
RESULTS	At 12 months , the intervention was significantly associated with an increase in alcohol-related discussions with physicians ( 23 % vs. 13 % ; p .01 ) and reductions in at-risk drinking ( 56 % vs. 67 % ; p .01 ) , alcohol consumption ( -2.19 drinks per week ; p .01 ) , physician visits ( -1.14 visits ; p = .03 ) , emergency department visits ( 16 % vs. 25 % ; p .01 ) , and nonprofessional caregiving visits ( 12 % vs. 17 % ; p .01 ) .
RESULTS	Average variable costs per patient were $ 31 for screening and $ 79 for intervention .
CONCLUSIONS	The intervention reduced alcohol consumption and at-risk drinking among older adults .
CONCLUSIONS	Effects were sustained over a year and may have been associated with lower health care utilization , offsetting screening and intervention costs .

###24703208
BACKGROUND	Uric acid is an antioxidant with neuroprotective effects in experimental models of stroke .
BACKGROUND	We assessed whether uric acid therapy would improve functional outcomes at 90 days in patients with acute ischaemic stroke .
METHODS	URICO-ICTUS was a randomised , double-blind , placebo-controlled , phase 2b/3 trial that recruited patients with acute ischaemic stroke admitted to ten Spanish stroke centres .
METHODS	Patients were included if they were aged 18 years or older , had received alteplase within 45 h of symptom onset , and had an eligible National Institutes of Health Stroke Scale ( NIHSS ) score ( > 6 and 25 ) and premorbid ( assessed by anamnesis ) modified Rankin Scale ( mRS ) score ( 2 ) .
METHODS	Patients were randomly allocated ( 1:1 ) to receive uric acid 1000 mg or placebo ( both infused intravenously in 90 min during the infusion of alteplase ) , stratified by centre and baseline stroke severity .
METHODS	The primary outcome was the proportion of patients with excellent outcome ( ie , an mRS score of 0-1 , or 2 if premorbid score was 2 ) at 90 days , analysed in the target population ( all randomly assigned patients who had been correctly diagnosed with ischaemic stroke and had begun study medication ) .
METHODS	The study is registered with ClinicalTrials.gov , number NCT00860366 .
RESULTS	Between July 1 , 2011 , and April 30 , 2013 , we randomly assigned 421 patients , of whom 411 ( 98 % ) were included in the target population ( 211 received uric acid and 200 received placebo ) .
RESULTS	83 ( 39 % ) patients who received uric acid and 66 ( 33 % ) patients who received placebo had an excellent outcome ( adjusted risk ratio 123 [ 95 % CI 096-156 ] ; p = 0099 ) .
RESULTS	No clinically relevant or statistically significant differences were reported between groups with respect to death ( 28 [ 13 % ] patients who received uric acid vs 31 [ 16 % ] who received placebo ) , symptomatic intracerebral haemorrhage ( nine [ 4 % ] vs six [ 3 % ] ) , and gouty arthritis ( one [ < 1 % ] vs four [ 2 % ] ) .
RESULTS	516 adverse events occurred in the uric acid group and 532 in the placebo group , of which 61 ( 12 % ) and 67 ( 13 % ) , respectively , were serious adverse events ( p = 0703 ) .
CONCLUSIONS	The addition of uric acid to thrombolytic therapy did not increase the proportion of patients who achieved excellent outcome after stroke compared with placebo , but it did not lead to any safety concerns .
BACKGROUND	Institute of Health Carlos III of the Spanish Ministry of Health and Fundacin Doctor Melchor Colet .

###24643895
BACKGROUND	Bimatoprost 0.03 % has enhanced eyelash prominence in clinical trials enrolling mostly Caucasian subjects .
BACKGROUND	The studies described in this report evaluated the efficacy and safety of bimatoprost in Japanese subjects with idiopathic and chemotherapy-induced eyelash hypotrichosis .
METHODS	In two multicenter , double-masked , randomized , parallel-group studies ( study 1 : n = 173 [ idiopathic ] ; study 2 : n = 36 [ chemotherapy-induced ] ) , subjects received bimatoprost 0.03 % or vehicle applied once daily to the upper eyelid margins .
METHODS	The primary efficacy measure was eyelash prominence measured by Global Eyelash Assessment ( GEA ) scores .
METHODS	Additional measures were eyelash length , thickness , and darkness , assessed by digital image analysis , and patient satisfaction ( Eyelash Satisfaction Questionnaire-9 ) .
METHODS	Safety assessments included adverse-event monitoring and ophthalmic examinations .
RESULTS	Significantly more bimatoprost-treated subjects had at least a one-grade improvement in GEA score from baseline to month 4 compared with vehicle in study 1 ( 77.3 vs 17.6 % ; P < 0.001 ) and study 2 ( 88.9 vs 27.8 % ; P < 0.001 ) .
RESULTS	Bimatoprost-treated subjects had significantly greater increases in eyelash length , thickness , and darkness at the primary time point ( month 4 in both studies ; all P < 0.001 , study 1 ; P0 .04 , study 2 ) .
RESULTS	The bimatoprost group showed greater subject satisfaction in both studies .
RESULTS	The incidence of adverse events was similar in the two groups .
RESULTS	Ophthalmic examination showed slightly greater mean reductions in intraocular pressure ( IOP ) with bimatoprost than with vehicle , and the reductions were within the normal range for daily IOP fluctuations .
CONCLUSIONS	Bimatoprost 0.03 % was shown to be effective and safe in these studies of Japanese subjects with eyelash hypotrichosis .
METHODS	This journal requires that authors assign a level of evidence to each article .
METHODS	For a full description of these Evidence-Based Medicine ratings , please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

###24466598
OBJECTIVE	To determine the efficacy of delivering short-message service ( SMS ) to provide diabetes-related information in reducing the risk of developing diabetes in Chinese professional drivers with pre-diabetes .
METHODS	A pilot single-blinded randomized controlled trial was conducted in Hong Kong between 05/2009 and 04/2012 .
METHODS	Professional drivers with impaired glucose tolerance ( IGT ) were randomly allocated to either a SMS group receiving messages comprising knowledge and lifestyle modification on diabetes or to a control group with usual care .
METHODS	Primary outcomes were the incidence rate of diabetes mellitus over 12 and 24 months period .
RESULTS	Fifty-four , out of 104 professional drivers recruited , were randomly allocated to intervention group .
RESULTS	Fewer subjects developed diabetes at 12 months in intervention group ( 5.56 % ) compared to control group ( 16.00 % ) .
RESULTS	Relative risk ( RR ) of diabetes onset was 0.35 ( 95 % CI : 0.101.24 ) and the number needed to treat ( NNT ) for preventing one diabetes was 9.57 .
RESULTS	At 24 months , RR increased to 0.62 ( 95 % CI : 0.241.61 ) with a NNT of 10.58 .
RESULTS	Logistic regression showed a significant odds ratio of 0.04 ( P = 0.021 ) for intervention group compared to control group at 12-month follow-up for completers and a non-significant odds ratio of 0.34 ( P = 0.303 ) at 24-month follow-up .
CONCLUSIONS	The SMS program proved to have potential to reduce the risk of developing diabetes at 12 months but additional measures should be integrated to prevent or delay disease progression .

###26255517
OBJECTIVE	To observe treatment efficacy of acupuncture at different distal acupoints for acute lumbar sprain after massage .
METHODS	One hundred and fifty patients with acute lumbar sprain were randomly divided into a Yaotongdian ( Extra ) group , a Houxi ( SI 3 ) group , a Weizhong ( BL 40 ) group , a Chengshan ( BL 57 ) group and a Shuigou ( GV 26 ) group , total 5 groups , 30 cases in each one .
METHODS	After the same massage treatment and based on groups divided , different distal acupoints above-mentioned were selected to be acupunctured .
METHODS	Visual analogue scale ( VAS ) scores , lumbar activity and treatment efficacy of patients in 5 groups were evaluated .
RESULTS	With acupuncture at distal acupoints after massage , VAS scores of patients in 5 groups were decreased compared with those after massage treatment ( all P < 0.05 ) ; lumbar activity was all obviously improved ( all P < 0.01 ) ; and cured and markedly effective rates were all increased in comparison with those after massage ( all P < 0.01 ) .
RESULTS	But among 5 groups the differences of VAS scores , lumbar activity and cured and markedly effective rates were not statistically significant ( all P > 0.05 ) .
CONCLUSIONS	Based on massage treatment , acupuncture at distal acupoints could further improve the treatment efficacy for acute lumbar sprain , but there is no obvious effective difference among every distal acupoint .
CONCLUSIONS	As long as choosing acupoints with lower pain threshold and stimulating enough , good efficacy could be acquired for acute lumbar sprain .

###25213621
OBJECTIVE	To compare closed and open orchidectomy in dogs and the associated complications .
METHODS	A randomised controlled blinded prospective clinical study of 73 cases was undertaken involving the recording of all complications during and in the 10days following orchidectomy of dogs fulfilling the standardised inclusion criteria .
METHODS	The active variable was the surgical technique of either open or closed orchidectomy .
RESULTS	Dogs undergoing open orchidectomy experienced significantly more complication events than the dogs undergoing closed orchidectomy [ 24 of 34 ( 70 % ) versus 18 of 39 ( 46 % ) , P = 004 ] .
RESULTS	Dogs undergoing open orchidectomy were statistically more likely to develop scrotal complications ( 21 of 34 , 61 % ) compared with dogs undergoing closed orchidectomy ( 13 of 39 , 33 % ; P = 002 ) .
CONCLUSIONS	Open orchidectomy is associated with a higher overall complication rate in the first 10days after surgery than closed orchidectomy .
CONCLUSIONS	Open orchidectomy is also associated with increased scrotal complications including swelling , bruising and pain compared with closed orchidectomy .

###24600218
BACKGROUND	There is much description in the literature of how patients with chronic obstructive pulmonary disease ( COPD ) manage their breathlessness and engage in self-care activities ; however , little of this is from the perspective of those with less severe disease , who are primarily managed in primary care .
BACKGROUND	This study aimed to understand the self-care experiences of patients with COPD who are primarily managed in primary care , and to examine the challenges of engaging in such behaviors .
METHODS	Semistructured interviews were carried out with 15 patients with COPD as part of a larger project evaluating a self-management intervention .
METHODS	Thematic analysis was supported by NVivo software ( version 8 , QSR International , Melbourne , Australia ) .
RESULTS	Three main themes are described , ie , experiencing and understanding symptoms of COPD , current self-care activities , and the importance of family perceptions in managing COPD .
CONCLUSIONS	Self-care activities evolved spontaneously as participants experienced symptoms of COPD .
CONCLUSIONS	However , there was a lack of awareness about whether these strategies would impact upon symptoms .
CONCLUSIONS	Perceptions of COPD by family members posed a challenge to self-care for some participants .
CONCLUSIONS	Health care professionals should elicit patients ' prior disease experiences and utilize spontaneous attempts at disease management in future self-management .
CONCLUSIONS	These findings have implications for promoting self-management and enhancing quality of life .

###24825530
BACKGROUND	Dexamethasone has analgesic properties when given intravenously before surgery , but the optimal dose has not been determined .
BACKGROUND	We hypothesised that a dose of 40 mg dexamethasone would improve analgesia after outpatient shoulder surgery compared with 8 mg .
METHODS	A randomised , double-blind , placebo-controlled clinical trial was conducted at Horsens Regional Hospital , Denmark .
METHODS	Patients scheduled for arthroscopic subacromial decompression and/or acromioclavicular joint resection as an outpatient procedure ( n = 101 ) were randomised to receive intravenous dexamethasone 40 mg ( D40 ) , 8 mg ( D8 ) or placebo ( D0 ) before surgery .
METHODS	The primary outcome was pain intensity 8 h after surgery rated on a numeric rating scale of 0 to 10 .
METHODS	Secondary outcomes were pain intensity , analgesic consumption and side effects during the first 3 days after surgery .
RESULTS	Data from 73 patients were available for analysis : ( D40 : 25 , D8 : 26 , D0 : 22 patients ) .
RESULTS	Eight hours after surgery , pain intensity were : [ median ( interquartile range ) ] group D40 : 2 ( 1-4 ) , group D8 : 2.5 ( 1-5 ) , group D0 : 4 ( 2-7 ) .
RESULTS	There was no significant difference in pain intensity between group D40 and D8 after 8 h ( P = 0.46 ) or at any other time .
RESULTS	When comparing all three groups , a statistically significant dose-response relationship was seen for present , average and worst pain intensity after 8 h and on the following morning .
RESULTS	No differences were found in analgesic consumption .
RESULTS	No serious side effects were observed .
CONCLUSIONS	Although our data supported a dose-response relationship , increasing the dexamethasone dose from 8 to 40 mg did not improve analgesia significantly after outpatient shoulder surgery .

###25118129
BACKGROUND	Major depressive disorder ( MDD ) is a long-lasting disorder with frequent relapses that have significant effects on the patient 's family .
BACKGROUND	Family psychoeducation is recognized as part of the optimal treatment for patients with psychotic disorder .
BACKGROUND	A previous randomized controlled trial has found that family psychoeducation is effective in enhancing the treatment of MDD .
BACKGROUND	Although MDD can easily become a chronic illness , there has been no intervention study on the families of patients with chronic depression .
BACKGROUND	In the present study , we design a randomized controlled trial to examine the effectiveness of family psychoeducation in improving the mental health of relatives of patients with MDD lasting more than one year .
METHODS	Participants are patients with MDD lasting more than one year and their relatives .
METHODS	Individually randomized , parallel-group trial design will be employed .
METHODS	Participants will be allocated to one of two treatment conditions : relatives will receive ( a ) family psychoeducation ( four , two-hour biweekly multifamily psychoeducation sessions ) plus treatment-as-usual for the patient ( consultation by physicians ) , or ( b ) counseling for the family ( one counseling session from a nurse ) plus treatment-as-usual for the patient .
METHODS	The primary outcome measure will be relatives ' mental health as measured by K6 that was developed to screen for DSM-IV depressive and anxiety disorder .
METHODS	Additionally , the severity of depressive symptoms in patients measured by the Beck Depression Inventory-II ( BDI-II ) scale will be assessed .
METHODS	Data from the intention-to-treat sample will be analyzed 16weeks after randomization .
CONCLUSIONS	This is the first study to evaluate the effectiveness of family psychoeducation for relatives of patients with MDD lasting more than one year .
CONCLUSIONS	If this type of intervention is effective , it could be a new method of rehabilitation for patients with MDD lasting more than one year .
BACKGROUND	Clinical Trials.gov NCT01734291 ( registration date : 18 October 2012 ) .

###24740205
BACKGROUND	Metabolomics is an emerging field with the potential to advance nutritional epidemiology ; however , it has not yet been applied to large cohort studies .
OBJECTIVE	Our first aim was to identify metabolites that are biomarkers of usual dietary intake .
OBJECTIVE	Second , among serum metabolites correlated with diet , we evaluated metabolite reproducibility and required sample sizes to determine the potential for metabolomics in epidemiologic studies .
METHODS	Baseline serum from 502 participants in the Prostate , Lung , Colorectal , and Ovarian ( PLCO ) Cancer Screening Trial was analyzed by using ultra-high-performance liquid-phase chromatography with tandem mass spectrometry and gas chromatography-mass spectrometry .
METHODS	Usual intakes of 36 dietary groups were estimated by using a food-frequency questionnaire .
METHODS	Dietary biomarkers were identified by using partial Pearson 's correlations with Bonferroni correction for multiple comparisons .
METHODS	Intraclass correlation coefficients ( ICCs ) between samples collected 1 y apart in a subset of 30 individuals were calculated to evaluate intraindividual metabolite variability .
RESULTS	We detected 412 known metabolites .
RESULTS	Citrus , green vegetables , red meat , shellfish , fish , peanuts , rice , butter , coffee , beer , liquor , total alcohol , and multivitamins were each correlated with at least one metabolite ( P < 1.093 10 ( -6 ) ; r = -0.312 to 0.398 ) ; in total , 39 dietary biomarkers were identified .
RESULTS	Some correlations ( citrus intake with stachydrine ) replicated previous studies ; others , such as peanuts and tryptophan betaine , were novel findings .
RESULTS	Other strong associations included coffee ( with trigonelline-N-methylnicotinate and quinate ) and alcohol ( with ethyl glucuronide ) .
RESULTS	Intraindividual variability in metabolite levels ( 1-y ICCs ) ranged from 0.27 to 0.89 .
RESULTS	Large , but attainable , sample sizes are required to detect associations between metabolites and disease in epidemiologic studies , further emphasizing the usefulness of metabolomics in nutritional epidemiology .
CONCLUSIONS	We identified dietary biomarkers by using metabolomics in an epidemiologic data set .
CONCLUSIONS	Given the strength of the associations observed , we expect that some of these metabolites will be validated in future studies and later used as biomarkers in large cohorts to study diet-disease associations .
CONCLUSIONS	The PLCO trial was registered at clinicaltrials.gov as NCT00002540 .

###25169728
OBJECTIVE	To assess the efficacy and safety of tocilizumab ( TCZ ) plus methotrexate/placebo ( MTX/PBO ) over 2years and the course of disease activity in patients who discontinued TCZ due to sustained remission .
METHODS	ACT-RAY was a double-blind 3-year trial .
METHODS	Patients with active rheumatoid arthritis despite MTX were randomised to add TCZ to ongoing MTX ( add-on strategy ) or switch to TCZ plus PBO ( switch strategy ) .
METHODS	Using a treat-to-target approach , open-label conventional synthetic disease-modifying antirheumatic drugs ( csDMARDs ) , other than MTX , were added from week 24 if Disease Activity Score in 28 joints based on erythrocyte sedimentation rate ( DAS28-ESR ) > 3.2 .
METHODS	Between weeks 52 and 104 , patients in sustained clinical remission ( DAS28-ESR < 2.6 at two consecutive visits 12weeks apart ) discontinued TCZ and were assessed every 4weeks for 1year .
METHODS	If sustained remission was maintained , added csDMARDs , then MTX/PBO , were discontinued .
RESULTS	Of the 556 randomised patients , 76 % completed year 2 .
RESULTS	Of patients entering year 2 , 50.4 % discontinued TCZ after achieving sustained remission and 5.9 % achieved drug-free remission .
RESULTS	Most patients who discontinued TCZ ( 84.0 % ) had a subsequent flare , but responded well to TCZ reintroduction .
RESULTS	Despite many patients temporarily stopping TCZ , radiographic progression was minimal , with differences favouring add-on treatment .
RESULTS	Rates of serious adverse events and serious infections per 100 patient-years were 12.2 and 4.4 in add-on and 15.0 and 3.7 in switch patients .
RESULTS	In patients with normal baseline values , alanine aminotransferase elevations > 3upper limit of normal were more frequent in add-on ( 14.3 % ) versus switch patients ( 5.4 % ) .
CONCLUSIONS	Treat-to-target strategies could be successfully implemented with TCZ to achieve sustained remission , after which TCZ was stopped .
CONCLUSIONS	Biologic-free remission was maintained for about 3months , but most patients eventually flared .
CONCLUSIONS	TCZ restart led to rapid improvement .
BACKGROUND	NCT00810199 .

###25341739
OBJECTIVE	The aim of this prospective substudy was to estimate the cost-effectiveness of treating paroxysmal atrial fibrillation ( AF ) with radiofrequency catheter ablation ( RFA ) compared with antiarrhythmic drugs ( AADs ) as first-line treatment .
RESULTS	A decision-analytic Markov model , based on MANTRA-PAF ( Medical Antiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation ) study data , was developed to study long-term effects and costs of RFA compared with AADs as first-line treatment .
RESULTS	Positive clinical effects were found in the overall population , a gain of an average 0.06 quality-adjusted life years ( QALYs ) to an incremental cost of 3033 , resulting in an incremental cost-effectiveness ratio of 50 570/QALY .
RESULTS	However , the result of the subgroup analyses showed that RFA was less costly and more effective in younger patients .
RESULTS	This implied an incremental cost-effectiveness ratio of 3434/QALY in 50-year-old patients respectively 108 937/QALY in > 50-year-old patients .
CONCLUSIONS	Radiofrequency catheter ablation as first-line treatment is a cost-effective strategy for younger patients with paroxysmal AF .
CONCLUSIONS	However , the cost-effectiveness of using RFA as first-line therapy in older patients is uncertain , and in most of these AADs should be attempted before RFA ( MANTRA-PAF ClinicalTrials.gov number ; NCT00133211 ) .

###25181622
OBJECTIVE	With the increasing rate of cesarean delivery ( CD ) worldwide , there is a need for a revision of practices to prevent post-partum hemorrhage ( PPH ) after CD .
OBJECTIVE	In search of a safe , cheap and effective alternative to oxytocin for prevention of PPH during the postoperative period of CD , the present study aimed to compare rectally administrated misoprostol with i.v. oxytocin infusion .
METHODS	A randomized , placebo-controlled , double-blind prospective trial was undertaken on 192 women who did not have risk factors for PPH and who had an uneventful emergency CD under spinal anesthesia .
METHODS	They were randomly allocated to receive either 800mg of rectal misoprostol or an i.v. infusion of oxytocin at the end of operation .
METHODS	Primary outcome measures were the amount of postoperative ( 24h ) blood loss and incidence of PPH during the postoperative period .
METHODS	The secondary outcome measures were the postoperative drop in hemoglobin concentration after 24h , need for additional uterotonic and blood transfusion , and side-effects/complications during the 24-h observation period .
RESULTS	There was a significant reduction of blood loss in the misoprostol group compared with the oxytocin group ( 144.5100.1 vs 191.7117.1 , P < 0.0001 ) .
RESULTS	The two groups were similar in terms of the secondary outcome parameters .
CONCLUSIONS	Rectally administrated 800-mg misoprostol may be an effective alternative to oxytocin infusion to prevent PPH after CD .

###24946629
OBJECTIVE	To compare the difference of the clinical efficacy on common peroneal palsy between the comprehensive therapy of electroacupuncture , moxibustion and moving cupping method and western medication .
METHODS	Ninety cases of common peroneal nerve palsy were randomized into a comprehensive therapy group and a western medication group , 45 cases in each one .
METHODS	In the comprehensive therapy group , electroacupuncture was applied to Yanglingquan ( GB 34 ) , Zusanli ( ST 36 ) , Xuanzhong ( GB 39 ) , Jiexi ( ST 41 ) , Taichong ( LR 3 ) , Zulinqi ( GB 41 ) and the others , combined with warm moxibustion and moving cupping on the lateral side of the affected leg .
METHODS	The comprehensive therapy was used once a day .
METHODS	In the western medication group , vitamin B1 , 10 mg each time , 3 times a day ; and mecobalamine , 0.5 mg each time , three times a day were prescribed for oral administration .
METHODS	In the two groups , 15 days made one session , and the efficacy was observed after 2 sessions treatment .
RESULTS	The total effective rate of the improvement of sensory function and motor nerve function was 97.8 % ( 44/45 ) in the comprehensive therapy group and was 82.2 % ( 37 / 45 ) in the western medication .
RESULTS	The efficacy in the comprehensive therapy group was better than that of the western medication ( P < 0.01 ) .
RESULTS	The electrophysiological examination showed that the amplitude of motor conduction of deep peroneal nerve and that of sensory conduction of surficial peroneal nerve after treatment were improved remarkably as compared with those before treatment in the comprehensive therapy group ( both P < 0.05 ) .
RESULTS	The amplitude of motor conduction of deep peroneal nerve was improved significantly in the comprehensive therapy group as compared with that in the western medication group ( P < 0.05 ) .
CONCLUSIONS	The comprehensive therapy of electroacupuncture , moxibustion and moving cupping method achieves the significant efficacy on common peroneal nerve palsy as compared with western medication .

###24892221
BACKGROUND	Patients with stroke present an asymmetric posture , severe balance dysfunction with delayed and disrupted equilibrium reactions , exaggerated postural sway and abnormal gait with an increased risk of falling .
BACKGROUND	The aim of this study is to evaluate the efficacy of hydrokinesytherapy on stance , balance and gait in individuals after stroke .
METHODS	In this single-blinded randomized controlled trial , patients with stroke were divided into two groups : an experimental one ( G1 ) , performing hydrokinesytherapy ( 3 times/week ) in addition to a conventional physical therapy ( 3 times/week ) and a control one ( G2 ) , performing only a conventional physical therapy ( 6 times/week ) .
METHODS	All of the participants underwent a proper clinical and baropodometric evaluation before and after 8 weeks of treatment .
RESULTS	The two groups presented similar clinical and instrumental features at enrolment ( mean modified Rankin Scale of 3 , and a disease duration of 6.3 1.4 months ) .
RESULTS	After treatment , the patients undergoing hydrokinesytherapy showed a significantly greater improvement than those undergoing traditional training .
CONCLUSIONS	Hydrokinesytherapy may be considered a promising treatment in improving gait and balance in individuals following stroke .

###25732163
OBJECTIVE	To evaluate the efficacy of maintenance sunitinib after chemotherapy for small-cell lung cancer ( SCLC ) .
METHODS	The Cancer and Leukemia Group B 30504 trial was a randomized , placebo-controlled , phase II study that enrolled patients before chemotherapy ( cisplatin 80 mg/m ( 2 ) or carboplatin area under the curve of 5 on day 1 plus etoposide 100 mg/m ( 2 ) per day on days 1 to 3 every 21 days for four to six cycles ) .
METHODS	Patients without progression were randomly assigned 1:1 to placebo or sunitinib 37.5 mg per day until progression .
METHODS	Cross-over after progression was allowed .
METHODS	The primary end point was progression-free survival ( PFS ) from random assignment for maintenance placebo versus sunitinib using a one-sided log-rank test with = .15 ; 80 randomly assigned patients provided 89 % power to detect a hazard ratio ( HR ) of 1.67 .
RESULTS	One hundred forty-four patients were enrolled ; 138 patients received chemotherapy .
RESULTS	Ninety-five patients were randomly assigned ; 10 patients did not receive maintenance therapy ( five on each arm ) .
RESULTS	Eighty-five patients received maintenance therapy ( placebo , n = 41 ; sunitinib , n = 44 ) .
RESULTS	Grade 3 adverse events with more than 5 % incidence were fatigue ( 19 % ) , decreased neutrophils ( 14 % ) , decreased leukocytes ( 7 % ) , and decreased platelets ( 7 % ) for sunitinib and fatigue ( 10 % ) for placebo ; grade 4 adverse events were GI hemorrhage ( n = 1 ) and pancreatitis , hypocalcemia , and elevated lipase ( n = 1 ; all in same patient ) for sunitinib and thrombocytopenia ( n = 1 ) and hypernatremia ( n = 1 ) for placebo .
RESULTS	Median PFS on maintenance was 2.1 months for placebo and 3.7 months for sunitinib ( HR , 1.62 ; 70 % CI , 1.27 to 2.08 ; 95 % CI , 1.02 to 2.60 ; one-sided P = .02 ) .
RESULTS	Median overall survival from random assignment was 6.9 months for placebo and 9.0 months for sunitinib ( HR , 1.28 ; 95 % CI , 0.79 to 2.10 ; one-sided P = .16 ) .
RESULTS	Three sunitinib and no placebo patients achieved complete response during maintenance .
RESULTS	Ten ( 77 % ) of 13 patients evaluable after cross-over had stable disease on sunitinib ( 6 to 27 weeks ) .
CONCLUSIONS	Maintenance sunitinib was safe and improved PFS in extensive-stage SCLC .

###25863828
BACKGROUND	Few data are available regarding the long-term mortality rate for patients receiving nocturnal home hemodialysis .
METHODS	Posttrial observational study .
METHODS	Frequent Hemodialysis Network ( FHN ) Nocturnal Trial participants who consented to extended follow-up .
METHODS	The FHN Nocturnal Trial randomly assigned 87 individuals to 6-times-weekly home nocturnal hemodialysis or 3-times-weekly hemodialysis for 1 year .
METHODS	Patients were enrolled starting in March 2006 and follow-up was completed by May 2010 .
METHODS	After the 1-year trial concluded , FHN Nocturnal participants were free to modify their hemodialysis prescription .
METHODS	We obtained dates of death and kidney transplantation through July 2011 using linkage to the US Renal Data System and queries of study centers .
METHODS	We used log-rank tests and Cox regression to relate mortality to the initial randomization assignment .
RESULTS	Median follow-up for the trial and posttrial observational period was 3.7 years .
RESULTS	In the nocturnal arm , there were 2 deaths during the 12-month trial period and an additional 12 deaths during the extended follow-up .
RESULTS	In the conventional arm , the numbers of deaths were 1 and 4 , respectively .
RESULTS	In the nocturnal dialysis group , the overall mortality HR was 3.88 ( 95 % CI , 1.27-11 .79 ; P = 0.01 ) .
RESULTS	Using as-treated analysis with a 12-month running treatment average , the HR for mortality was 3.06 ( 95 % CI , 1.11-8 .43 ; P = 0.03 ) .
RESULTS	Six-month running treatment data analysis showed an HR of 1.12 ( 95 % CI , 0.44-3 .22 ; P = 0.7 ) .
CONCLUSIONS	These results should be interpreted cautiously due to a surprisingly low ( 0.03 deaths/patient-year ) mortality rate for individuals randomly assigned to conventional home hemodialysis , low statistical power for the mortality comparison due to the small sample size , and the high rate of hemodialysis prescription changes .
CONCLUSIONS	Patients randomly assigned to nocturnal hemodialysis had a higher mortality rate than those randomly assigned to conventional dialysis .
CONCLUSIONS	The implications of this result require further investigation .

###24721108
BACKGROUND	Among glioma patients , depression is estimated to be more prevalent than in both the general population and the cancer patient population .
BACKGROUND	This can have negative consequences for both patients and their primary informal caregivers ( e.g. , a spouse , family member or close friend ) .
BACKGROUND	At present , there is no evidence from randomized controlled trials for the effectiveness of psychological treatment for depression in glioma patients .
BACKGROUND	Furthermore , the possibility of delivering mental health care through the internet has not yet been explored in this population .
BACKGROUND	Therefore , a randomized controlled trial is warranted to evaluate the effects of an internet-based , guided self-help intervention for depressive symptoms in glioma patients .
METHODS	The intervention is based on problem-solving therapy .
METHODS	An existing 5-week course is adapted for use by adult glioma patients with mild to moderate depressive symptoms ( Center for Epidemiology Studies Depression Scale score 12 ) .
METHODS	Sample size calculations yield 126 glioma patients to be included , who are randomly assigned to either the intervention group or a waiting list control group .
METHODS	In addition , we aim to include 63 patients with haematological cancer in a non-central nervous system malignancy control group .
METHODS	Assessments take place at baseline , after 6 and 12 weeks , and after 6 and 12 months .
METHODS	Primary outcome measure is the change in depressive symptoms .
METHODS	Secondary outcome measures include health-related quality of life , fatigue , costs and patient satisfaction .
METHODS	In addition , all patients are asked to assign a primary informal caregiver , who does not participate in the intervention but who is asked to complete similar assessments .
METHODS	Their mood , health-related quality of life and fatigue is evaluated as well .
CONCLUSIONS	This is the first study to evaluate the effects of problem-solving therapy delivered through the internet as treatment for depressive symptoms in glioma patients .
CONCLUSIONS	If proven effective , this treatment will contribute to the mental health care of glioma patients in clinical practice .
BACKGROUND	Netherlands Trial Register NTR3223 .

###25455833
OBJECTIVE	The purpose of this study was to examine the relationship in change scores between regional lumbar motion and patient-rated pain of the previous week and back-related function in chronic low back pain patients enrolled in a randomized clinical trial and treated with either exercise therapy or spinal manipulation using 6 different motion parameters .
METHODS	Regional lumbar motions were sampled using a 6 degrees of freedom instrumented spatial linkage system in 199 participants at baseline and 12-week follow-up .
METHODS	The regional lumbar motion data were analyzed as a total cohort as well as relative to subgroup stratifications ; back pain only vs back and leg pain , and treatment modality .
METHODS	For identifying clinically meaningful improvements in the measurements of back pain and back-related function , we used a 30 % threshold .
RESULTS	The relationship between change scores in patient-rated outcomes and objective measures of regional lumbar motion was found to be weak .
RESULTS	In contrast , distribution of pain and treatment received affected associations between motion parameters and patient-rated outcomes .
RESULTS	Thus , stronger correlation coefficients and significant differences between clinically relevant improved vs no clinical relevant change were found in some motion parameters in the subgroup with back pain only and the treatment group receiving spinal manipulation .
CONCLUSIONS	Overall , changes in regional lumbar motion were poorly associated with patient-rated outcomes measured by back-related function and back pain intensity scores .
CONCLUSIONS	However , associations between regional lumbar motion vs patient-rated pain and back-related function were different in relative subgroups ( back pain only vs back and leg pain and treatment ) .

###24424711
OBJECTIVE	We investigated the hypothesis that rimonabant , a cannabinoid antagonist/inverse agonist , would increase anxiety in healthy subjects during a simulation of the public speaking test .
METHODS	Participants were randomly allocated to receive oral placebo or 90mg rimonabant in a double-blind design .
METHODS	Subjective effects were measured by Visual Analogue Mood Scale .
METHODS	Physiological parameters , namely arterial blood pressure and heart rate , also were monitored .
RESULTS	Twelve participants received oral placebo and 12 received 90mg rimonabant .
RESULTS	Rimonabant increased self-reported anxiety levels during the anticipatory speech and performance phase compared with placebo .
RESULTS	Interestingly , rimonabant did not modulate anxiety prestress and was not associated with sedation , cognitive impairment , discomfort , or blood pressure changes .
CONCLUSIONS	Cannabinoid-1 antagonism magnifies the responses to an anxiogenic stimulus without interfering with the prestress phase .
CONCLUSIONS	These data suggest that the endocannabinoid system may work on-demand to counteract the consequences of anxiogenic stimuli in healthy humans .

###24267005
BACKGROUND	Hypovitaminosis D , especially during cold seasons , is quite prevalent among primary school children in Tehran .
BACKGROUND	The present study aimed to compare the efficacy of calcium-vitamin D-fortified-milk , - orange juice and supplement in primary school children .
METHODS	Children aged 9-12years from both sexes were randomly assigned to one of six groups to receive plain milk , fortified milk , plain orange juice , fortified orange juice , supplement or placebo .
METHODS	Both fortified-milk and - juice contained 100IU of vitamin D and 500mg of calcium per 200mL package , whereas supplement contained 200IU of vitamin D and 500mg of calcium .
METHODS	The duration of intervention was 12weeks , from November 2008 to March 2009 .
RESULTS	A total of 410 children completed the study .
RESULTS	Regression analysis with adjustment for both sex and initial values of 25 ( OH ) D revealed that consumption of either supplement , fortified orange juice or fortified milk resulted in a 20.8 nm [ confidence interval ( CI ) = 17.4-23 .9 ] , 9.9 nm ( CI = 7.4-12 .3 ) or 6.9 nm ( CI = 3.3-10 .5 ) increase in circulating 25 ( OH ) D compared to the related control groups .
RESULTS	However , changes in serum osteocalcin and intact parathyroid hormone in the supplement group did not differ from those of fortified milk or plain milk .
RESULTS	The increment of osteocalcin in both plain milk and fortified milk was more than in fortified orange juice , although the difference was statistically insignificant .
CONCLUSIONS	Despite having double amount of vitamin D and being more effective in raising serum 25 ( OH ) D , supplementation did not confer additional benefit in terms of osteocalcin and intact parathyroid hormone compared to either fortified or plain milk .

###24693953
BACKGROUND	Echocardiographic optimization of pacemaker settings is the current standard of care for patients treated with cardiac resynchronization therapy .
BACKGROUND	However , the process requires considerable time of expert staff .
BACKGROUND	The BRAVO study is a non-inferiority trial comparing echocardiographic optimization of atrioventricular ( AV ) and interventricular ( VV ) delay with an alternative method using non-invasive blood pressure monitoring that can be automated to consume less staff resources .
METHODS	BRAVO is a multi-centre , randomized , cross-over , non-inferiority trial of 400 patients with a previously implanted cardiac resynchronization device .
METHODS	Patients are randomly allocated to six months in each arm .
METHODS	In the echocardiographic arm , AV delay is optimized using the iterative method and VV delay by maximizing LVOT VTI .
METHODS	In the haemodynamic arm AV and VV delay are optimized using non-invasive blood pressure measured using finger photoplethysmography .
METHODS	At the end of each six month arm , patients undergo the primary outcome measure of objective exercise capacity , quantified as peak oxygen uptake ( VO2 ) on a cardiopulmonary exercise test .
METHODS	Secondary outcome measures are echocardiographic measurement of left ventricular remodelling , quality of life score and N-terminal pro B-type Natriuretic Peptide ( NT-pro BNP ) .
METHODS	The study is scheduled to complete recruitment in December 2013 and to complete follow up in December 2014 .
CONCLUSIONS	If exercise capacity is non-inferior with haemodynamic optimization compared with echocardiographic optimization , it would be proof of concept that haemodynamic optimization is an acceptable alternative which has the potential to be more easily implemented .
BACKGROUND	Clinicaltrials.gov NCT01258829 .

###25061708
OBJECTIVE	To evaluate the effects of clopidogrel on clinical and clinicopathologic variables in healthy horses with experimentally induced endotoxemia .
METHODS	12 adult mares .
METHODS	Procedures-Horses were assigned with a randomization procedure to receive clopidogrel ( 4 mg/kg , once , then 2 mg/kg , q 24 h ; n = 6 ) or a placebo ( 6 ) through a nasogastric tube .
METHODS	After 72 hours of treatment , horses received lipopolysaccharide ( LPS ; 30 ng/kg , IV ) .
METHODS	Heart rate , respiratory rate , rectal temperature , CBC variables , plasma fibrinogen concentration , serum tumor necrosis factor - concentration , plasma von Willebrand factor concentration , and measures of platelet activation ( including ADP - and collagen-induced platelet aggregation and closure times , thrombelastography variables , and results of flow cytometric detection of platelet membrane P-selectin , phosphatidylserine , and microparticles ) were determined at various times before and after LPS administration by investigators unaware of the treatment groups .
METHODS	Statistical analyses were performed with repeated-measures ANOVA .
RESULTS	4 of 6 clopidogrel-treated horses had significant decreases in ADP-induced platelet aggregation before and after LPS administration .
RESULTS	Heart rate increased significantly after LPS administration only for the placebo group .
RESULTS	No significant differences were detected between groups for CBC variables , closure time , and plasma concentration of fibrinogen or serum concentration of tumor necrosis factor - , and no clinically relevant differences were detected for other hemostatic variables .
CONCLUSIONS	In this study , administration of LPS did not induce platelet hyperreactivity in horses on the basis of measures of platelet adhesion , aggregation , degranulation , and procoagulant activity .
CONCLUSIONS	Administration of clopidogrel was associated with variable platelet antiaggregatory activity and attenuated some clinical signs of endotoxemia .

###25096607
BACKGROUND	Exercise has been reported to decrease cancer-related fatigue and to increase quality of life ( QoL ) in various breast cancer ( BC ) populations .
BACKGROUND	However , studies investigating exercise during radiotherapy or resistance training are scarce .
BACKGROUND	We conducted a randomized , controlled trial ( BEST study ) to assess the efficacy of 12-week resistance training on fatigue beyond possible psychosocial effects of a group-based intervention .
METHODS	One hundred sixty patients with BC stage 0-III were randomly assigned to a 12-week progressive resistance training ( 2 times/week ) or a 12-week relaxation control ( RC , 2 times/week ) .
METHODS	Both interventions were group-based .
METHODS	The primary end point fatigue was assessed with a 20-item multidimensional questionnaire , QoL with EORTC questionnaires .
METHODS	Statistical analyses were based on analysis of covariance models for the individual changes from baseline to week 13 .
RESULTS	Adherence to the intervention program as well as the completion rate ( 97 % ) for the primary outcome variable fatigue was high .
RESULTS	In intention-to-treat analyses for the N = 155 patients , significant between-group mean differences ( MD ) favoring the exercise group ( EX ) were observed for general fatigue ( P = 0.044 ) , especially for the subscale physical fatigue [ MD = -0.8 ; 95 % confidence interval -1.5 to -0.2 , P = 0.013 ] , but not for affective ( P = 0.91 ) or cognitive fatigue ( P = 0.65 ) .
RESULTS	For QoL , significantly larger improvements regarding the role function ( P = 0.035 ) and pain ( P = 0.040 ) were noted among exercisers compared with RCs .
RESULTS	Future perspective improved significantly stronger in the RC group compared with the EX group ( P = 0.047 ) .
CONCLUSIONS	The 12-week resistance training program was a safe , feasible and efficacious strategy to improve cancer-related fatigue and components of QoL in BC patients during adjuvant radiotherapy .
CONCLUSIONS	As exercise was compared with another group-based intervention , results indicate that resistance training effects on fatigue and QoL go beyond psychosocial benefits , and that the clinically relevant overall benefit of resistance exercise compared with usual care can be assumed to be higher .
BACKGROUND	ClinicalTrials.gov NCT01468766 .

###24481910
BACKGROUND	Chronic kidney disease ( CKD ) is associated with an increased risk of cardiovascular events following acute coronary syndrome ( ACS ) .
BACKGROUND	The underlying pathobiology and optimal treatments for this population continue to be evaluated .
OBJECTIVE	Patients with CKD will receive fewer evidence-based therapies and experience high rates of adverse cardiovascular events in both the short - and long term .
METHODS	The MERLIN-TIMI 36 ( Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST-Elevation Acute Coronary Syndromes-Thrombolysis in Myocardial Infarction 36 ) trial randomized non-ST-elevation ACS patients to ranolazine or placebo , with no exclusion for renal dysfunction ( except dialysis ) .
METHODS	We conducted a prespecified analysis among 6543 patients based on the degree of CKD .
RESULTS	Patients with worse renal function were older with more comorbidities ( P < 0.0001 for each ) .
RESULTS	They were less likely to receive evidence-based cardiovascular medicines ( P < 0.04 for each ) .
RESULTS	Rates of an early invasive management strategy varied based on renal function ; however , among patients with the highest TIMI risk scores , the rates of an early invasive management strategy were similar regardless of glomerular filtration rate ( GFR ) ( Pinteraction = 0.005 ) .
RESULTS	Lower GFR was associated with increased rates of cardiovascular disease or myocardial infarction in the short and long term , even after adjustment ( GFR < 30 vs 90 mL/min/1 .73 m ( 2 ) ; hazard ratio [ HR ] : 3.24 [ 95 % confidence interval { CI } : 1.26-8 .38 ] through 7 days and HR : 2.12 [ 95 % CI : 1.33-3 .39 ] through 1 year ) .
RESULTS	The effect of ranolazine vs placebo on clinical outcomes was similar among those with and without CKD ( Pinteraction = not significant ) .
CONCLUSIONS	Following ACS , patients with renal dysfunction had more cardiovascular risk factors but were less likely to receive evidence-based medical therapies .
CONCLUSIONS	A strong graded , independent relationship between the degree of CKD and poor clinical outcomes was observed over time .
CONCLUSIONS	Continued efforts to optimize ACS treatment strategies in patients with CKD are warranted .

###25500229
BACKGROUND	Empiric circumferential pulmonary vein isolation ( CPVI ) has become the therapy of choice for drug-refractory atrial fibrillation ( AF ) .
BACKGROUND	Although results are suboptimal , it is unknown whether mechanistically-based strategies targeting AF drivers are superior .
OBJECTIVE	This study sought to determine the efficacy and safety of localized high-frequency source ablation ( HFSA ) compared with CPVI in patients with drug-refractory AF .
METHODS	This prospective , multicenter , single-blinded study of 232 patients ( age 53 10 years , 186 males ) randomized those with paroxysmal AF ( n = 115 ) to CPVI or HFSA-only ( noninferiority design ) and those with persistent AF ( n = 117 ) to CPVI or a combined ablation approach ( CPVI + HFSA , superiority design ) .
METHODS	The primary endpoint was freedom from AF at 6 months post-first ablation procedure .
METHODS	Secondary endpoints included freedom from atrial tachyarrhythmias ( AT ) at 6 and 12 months , periprocedural complications , overall adverse events , and quality of life .
RESULTS	In paroxysmal AF , HFSA failed to achieve noninferiority at 6 months after a single procedure but , after redo procedures , was noninferior to CPVI at 12 months for freedom from AF and AF/AT .
RESULTS	Serious adverse events were significantly reduced in the HFSA group versus CPVI patients ( p = 0.02 ) .
RESULTS	In persistent AF , there were no significant differences between treatment groups for primary and secondary endpoints , but CPVI + HFSA trended toward more serious adverse events .
CONCLUSIONS	In paroxysmal AF , HFSA failed to achieve noninferiority at 6 months but was noninferior to CPVI at 1 year in achieving freedom of AF/AT and a lower incidence of severe adverse events .
CONCLUSIONS	In persistent AF , CPVI + HFSA offered no incremental value .
CONCLUSIONS	( Radiofrequency Ablation of Drivers of Atrial Fibrillation [ RADAR-AF ] ; NCT00674401 ) .

###25013370
OBJECTIVE	This study evaluated the non-inferiority of renoprotection afforded by benidipine versus hydrochlorothiazide in hypertensive patients with chronic kidney disease ( CKD ) .
METHODS	In this prospective , multicenter , open-labeled , randomized trial , the antialbuminuric effects of benidipine and hydrochlorothiazide were examined in renin-angiotensin system ( RAS ) inhibitor-treated patients with blood pressure ( BP ) readings of 130/80 mmHg and 180/110 mmHg , a urinary albumin to creatinine ratio ( UACR ) of 300 mg/g , and an estimated glomerular filtration rate ( eGFR ) of 30 ml/min/1 .73 m ( 2 ) .
METHODS	Patients received benidipine ( n = 176 , final dose : 4.8 mg/day ) or hydrochlorothiazide ( n = 170 , 8.2 mg/day ) for 12 months .
RESULTS	Benidipine and hydrochlorothiazide exerted similar BP - and eGFR-decreasing actions .
RESULTS	The UACR values for benidipine and hydrochlorothiazide were 930.8 ( 95 % confidence interval : 826.1 , 1048.7 ) and 883.1 ( 781.7 , 997.7 ) mg/g at baseline , respectively .
RESULTS	These values were reduced to 790.0 ( 668.1 , 934.2 ) and 448.5 ( 372.9 , 539.4 ) mg/g at last observation carried forward ( LOCF ) visits .
RESULTS	The non-inferiority of benidipine versus hydrochlorothiazide was not demonstrated ( benidipine/hydrochlorothiazide ratio of LOCF value adjusted for baseline : 1.67 ( 1.40 , 1.99 ) ) .
CONCLUSIONS	The present study failed to demonstrate the non-inferiority of the antialbuminuric effect of benidipine relative to that of hydrochlorothiazide in RAS inhibitor-treated hypertensive patients with macroalbuminuria .

###24828850
OBJECTIVE	A unilateral paravertebral ( PVB ) block with catheter can provide extendable analgesia without physiological changes .
OBJECTIVE	The objective of this study was to assess the efficacy of PVB bupivacaine for providing perioperative pain relief in adults undergoing percutaneous nephrolithotomy ( PCNL ) under general anesthesia .
METHODS	Fifty American Society of Anesthesiologists Grade I , II patients , aged 18 to 65 years , were included in this prospective , randomized , controlled , observer blinded trial .
METHODS	PVB group patients received preinduction 20mL of 0.5 % bupivacaine in the T9-10 paravertebral space and a catheter in addition to general anesthesia .
METHODS	Control group patients received only general anesthesia .
METHODS	All patients received intravenous fentanyl ( 2g/kg on induction , 0.5 g/kg on 20 % increase in heart rate or mean blood pressure ) and paracetamol every 6 hours .
METHODS	Postoperative pain was assessed using the visual analog scale ( VAS ) ( 0-10cm ) at rest and movement by a blinded observer at 0 , 1 , 2 , 4 , 6 , 12 , and 24 hours postoperatively .
RESULTS	Data of 48 patients were analyzed .
RESULTS	Intraoperative fentanyl requirement was higher in the control group ( 2.740.75 g/kg [ 95 % confidence interval ( CI ) 2.42 , 3.05 ] ) than the PVB group ( 2.070.26 g/kg [ 95 % CI 1.96 , 2.18 ] ) , ( P = 0.0001 ) .
RESULTS	Time to first postoperative analgesic requirement was longer in the PVB group ( 120min [ 30-570 ] ) than the control group ( 30min [ 0-180 ] ) , ( P = 0.0000 ) .
RESULTS	The VAS on rest ( 0 , 1 , 2 , and 12h ) and movement ( all time points ) were significantly lower in the PVB group .
RESULTS	Postoperative fentanyl consumption was lower in this group ( 175g [ 25-475 ] ) compared with the control group ( 525g [ ( 150-1275 ] ) , ( P = 0.0000 ) .
CONCLUSIONS	Unilateral PVB block with catheter provided effective perioperative analgesia for PCNL .

###25996491
OBJECTIVE	Glaucoma-related adverse events constitute major sight-threatening complications of cataract removal in infancy , yet their relationship to aphakia vs primary intraocular lens ( IOL ) implantation remains unsettled .
OBJECTIVE	To identify and characterize cases of glaucoma and glaucoma-related adverse events ( glaucoma + glaucoma suspect ) among children in the Infant Aphakia Treatment Study by the age of 5 years .
METHODS	A multicenter randomized clinical trial of 114 infants with unilateral congenital cataract in referral centers who were between ages 1 and 6 months at surgery .
METHODS	Mean follow-up was 4.8 years .
METHODS	This secondary analysis was conducted from December 23 , 2004 , to November 13 , 2013 .
METHODS	Participants were randomized at cataract surgery to either primary IOL or no IOL implantation ( contact lens ) .
METHODS	Standardized definitions of glaucoma and glaucoma suspect were created for the Infant Aphakia Treatment Study and applied for surveillance and diagnosis .
METHODS	Development of glaucoma and glaucoma + glaucoma suspect in operated on eyes for children up to age 5 years , plus intraocular pressure , visual acuity , and axial length at age 5 years .
RESULTS	Product limit estimates of the risk for glaucoma and glaucoma + glaucoma suspect at 4.8 years after surgery were 17 % ( 95 % CI , 11 % -25 % ) and 31 % ( 95 % CI , 24 % -41 % ) , respectively .
RESULTS	The contact lens and IOL groups were not significantly different for either outcome : glaucoma ( hazard ratio [ HR ] , 0.8 ; 95 % CI , 0.3-2 .0 ; P = .62 ) and glaucoma + glaucoma suspect ( HR , 1.3 ; 95 % CI , 0.6-2 .5 ; P = .58 ) .
RESULTS	Younger ( vs older ) age at surgery conferred an increased risk for glaucoma ( 26 % vs 9 % , respectively ) at 4.8 years after surgery ( HR , 3.2 ; 95 % CI , 1.2-8 .3 ) , and smaller ( vs larger ) corneal diameter showed an increased risk for glaucoma + glaucoma suspect ( HR , 2.5 ; 95 % CI , 1.3-5 .0 ) .
RESULTS	Age and corneal diameter were significantly positively correlated .
RESULTS	Glaucoma was predominantly open angle ( 19 of 20 cases , 95 % ) , most eyes received medication ( 19 of 20 , 95 % ) , and 8 of 20 eyes ( 40 % ) underwent surgery .
CONCLUSIONS	These results suggest that glaucoma-related adverse events are common and increase between ages 1 and 5 years in infants after unilateral cataract removal at 1 to 6 months of age ; primary IOL placement does not mitigate their risk but surgery at a younger age increases the risk .
CONCLUSIONS	Longer follow-up of these children may further characterize risk factors , long-term outcomes , potential differences between eyes having primary IOL vs aphakia , and optimal timing of unilateral congenital cataract removal .
BACKGROUND	clinicaltrials.gov Identifier : NCT00212134 .

###24282157
OBJECTIVE	DSM-5 has dropped subtyping of bulimia nervosa ( BN ) , opting to continue inclusion of the somewhat contentious diagnosis of BN-nonpurging subtype ( BN-NP ) within a broad BN category .
OBJECTIVE	Some contend however that BN-NP is more like binge eating disorder ( BED ) than BN-P .
OBJECTIVE	This study examines clinical characteristics , eating disorder symptomatology , and Axis I comorbidity in BN-NP , BN-P , and BED groups to establish whether BN-NP more closely resembles BN-P or BED .
METHODS	Women with BN-P ( n = 29 ) , BN-NP ( n = 29 ) , and BED ( n = 54 ) were assessed at baseline in an outpatient psychotherapy trial for those with binge eating .
METHODS	Measures included the Structured Clinical Interviews for DSM-IV , Eating Disorder Examination , and Eating Disorder Inventory-2 .
RESULTS	The BN-NP subtype had BMIs between those with BN-P and BED .
RESULTS	Both BN subtypes had higher Restraint and Drive for Thinness scores than BED .
RESULTS	Body Dissatisfaction was highest in BN-NP and predicted BN-NP compared to BN-P .
RESULTS	Higher Restraint and lower BMI predicted BN-NP relative to BED .
RESULTS	BN-NP resembled BED with higher lifetime BMIs ; and weight-loss clinic than eating disorder clinic attendances relative to the BN-P subtype .
RESULTS	Psychiatric comorbidity was comparable except for higher lifetime cannabis use disorder in the BN-NP than BN-P subtype
CONCLUSIONS	These results suggest that BN-NP sits between BN-P and BED however the high distress driving inappropriate compensatory behaviors in BN-P requires specialist eating disorder treatment .
CONCLUSIONS	These results support retaining the BN-NP group within the BN category .
CONCLUSIONS	Further research is needed to determine whether there are meaningful differences in outcome over follow-up .

###25556383
OBJECTIVE	Preclinical studies and early pilot clinical investigations have suggested that N-acetylcysteine ( NAC ) may be useful in treatment of methamphetamine ( METH ) dependence .
OBJECTIVE	The present study evaluated whether NAC would suppress craving to the METH .
METHODS	In a double-blind , controlled crossover clinical trial , 32 METH-dependent volunteers were chosen to receive either NAC ( 1200 mg/day ) or placebo , randomly .
METHODS	They were intervened in two four-week sessions .
METHODS	During first session they received either 1200 mg/day of NAC ( group A ) or placebo ( group B ) .
METHODS	After three days of washout period , next session started with the crossover intervention of the previous regimen .
METHODS	During these eight weeks , all participants received standardized , and Matrix Model of treatment .
METHODS	Craving was assessed using the Cocaine Craving Questionnaire-Brief ( CCQ-Brief ) .
METHODS	The data were analyzed using SPSS version 20.0 ( SPSS Inc. .
METHODS	Chicago , Illinois , USA ) .
RESULTS	In 23 subjects who completed the study , the mean score of CCQ-Brief reduced in four consecutive weeks with NAC treatment .
RESULTS	The mean ( SD ) scores of carving in group A and B were 3.38 ( 1.16 ) and 5.96 ( 1.03 ) , at the end of first session ; and 4.57 ( 1.88 ) and 3.2 ( 0.86 ) , at the end of the second session , respectively .
RESULTS	Our findings indicate that the main effect was significant for NAC ( P < 0.001 ) .
RESULTS	Across placebo and NAC conditions , only mild side effects were noted , and the number of subjects who reported side effects did not differ .
CONCLUSIONS	The NAC showed good efficacy in suppressing METH craving , and may be a useful pharmacological treatment for METH dependency .

###24750904
BACKGROUND	Stroke is a leading cause of death worldwide .
BACKGROUND	Infections after stroke occur in 30 % of stroke patients and are strongly associated with unfavourable outcome .
BACKGROUND	Preventive antibiotic therapy lowers infection rate in patients after stroke , however , the effect of preventive antibiotic treatment on functional outcome after stroke has not yet been investigated.The Preventive Antibiotics in Stroke Study ( PASS ) is an ongoing , multicentre , prospective , randomised , open-label , blinded end point trial of preventive antibiotic therapy in acute stroke .
BACKGROUND	Patients are randomly assigned to either ceftriaxone at a dose of 2g , given every 24hours intravenously for four-days , in addition to stroke-unit care , or standard stroke-unit care without preventive antibiotic therapy .
BACKGROUND	Aim of the study is to assess whether preventive antibiotic treatment improves functional outcome at three months by preventing infections .
RESULTS	To date , 2,470 patients have been included in PASS .
RESULTS	Median stroke severity of the first 2,133 patients ( second interim analysis ) is 5 ( IQR 3 to 9 ) on the National Institutes of Health Stroke Scale ( NIHSS ) .
RESULTS	Due to the PROBE design , no outcome data are available yet .
RESULTS	In the initial trial protocol we proposed a dichotomisation of the mRS as primary analysis of outcome and ordinal regression analysis as secondary analysis of primary outcome , requiring a sample size of 3,200 patients .
RESULTS	However , ordinal analysis of outcome data is becoming increasingly more common in acute stroke trials , as it increases statistical power .
RESULTS	For PASS , funding is insufficient for inclusion of 3,200 patients with the overall inclusion rate of 15 patients per week .
RESULTS	Therefore we change the analysis of our primary outcome from dichotomisation to ordinal regression analysis on the mRS. Power analysis showed that with similar assumptions 2,550 patients are needed using ordinal regression analysis .
RESULTS	We expect to complete follow-up in June 2014 .
RESULTS	A full statistical analysis plan will be submitted for publication before treatment allocation will be unblinded .
CONCLUSIONS	The data from PASS will establish whether preventive antibiotic therapy in acute stroke improves functional outcome by preventing infection .
CONCLUSIONS	In this update , we changed our primary outcome analysis from dichotomisation to ordinal regression analysis .
BACKGROUND	Current controlled trials ; ISRCTN66140176 .
BACKGROUND	Date of registration : 6 April 2010 .

###25104262
BACKGROUND	HIV counselling and testing and linkage to care are crucial for successful HIV prevention and treatment .
BACKGROUND	Abbreviated counselling could save time ; however , its effect on HIV risk is uncertain and methods to improve linkage to care have not been studied .
METHODS	We did this factorial randomised controlled study at Mulago Hospital , Uganda .
METHODS	Participants were randomly assigned to abbreviated or traditional HIV counselling and testing ; HIV-infected patients were randomly assigned to enhanced linkage to care or standard linkage to care .
METHODS	All study personnel except counsellors and the data officer were masked to study group assignment .
METHODS	Participants had structured interviews , given once every 3 months .
METHODS	We compared sexual risk behaviour by counselling strategy with a 65 % non-inferiority margin .
METHODS	We used Cox proportional hazards analyses to compare HIV outcomes by linkage to care over 1 year and tested for interaction by sex .
METHODS	This trial is registered with ClinicalTrials.gov ( NCT00648232 ) .
RESULTS	We enrolled 3415 participants ; 1707 assigned to abbreviated counselling versus 1708 assigned to traditional .
RESULTS	Unprotected sex with an HIV discordant or status unknown partner was similar in each group ( 232/823 [ 279 % ] vs 251/890 [ 282 % ] , difference -03 % , one-sided 95 % CI 32 ) .
RESULTS	Loss to follow-up was lower for traditional counselling than for abbreviated counselling ( adjusted hazard ratio [ HR ] 061 , 95 % CI 044-083 ) .
RESULTS	1003 HIV-positive participants were assigned to enhanced linkage ( n = 504 ) or standard linkage to care ( n = 499 ) .
RESULTS	Linkage to care did not have a significant effect on mortality or receipt of co-trimoxazole .
RESULTS	Time to treatment in men with CD4 cell counts of 250 cells per L or fewer was lower for enhanced linkage versus standard linkage ( adjusted HR 060 , 95 % CI 041-087 ) and time to HIV care was decreased among women ( 080 , 066-096 ) .
CONCLUSIONS	Abbreviated HIV counselling and testing did not adversely affect risk behaviour .
CONCLUSIONS	Linkage to care interventions might decrease time to enrolment in HIV care and antiretroviral treatment and thus might affect secondary HIV transmission and improve treatment outcomes .
BACKGROUND	US National Institute of Mental Health .

###24385117
BACKGROUND	Tinea cruris , a pruritic superficial fungal infection of the groin , is the second most common clinical presentation for dermatophytosis .
OBJECTIVE	This phase 3 study evaluated the safety and efficacy of topical luliconazole cream 1 % in patients with tinea cruris .
METHODS	483 patients were enrolled and 256 male and female patients aged 12 years with clinically evident tinea cruris and eligible for modified intent-to-treat analysis were randomized 2:1 to receive luliconazole cream 1 % ( n = 165 ) or vehicle ( n = 91 ) once daily for 7 days .
METHODS	Efficacy was evaluated at baseline and at days 7 , 14 , 21 , and 28 based on mycology ( potassium hydroxide , fungal culture ) and clinical signs ( erythema , scaling , pruritus ) .
METHODS	The primary outcome was complete clearance at day 28 ( 21 days posttreatment ) .
METHODS	Safety evaluations included adverse events and laboratory assessments .
RESULTS	Complete clearance was obtained in 21.2 % ( 35/165 ) of patients treated with luliconazole cream 1 % compared with 4.4 % ( 4/91 ) treated with vehicle ( P < 0.001 ) .
RESULTS	The safety profile of luliconazole cream 1 % was similar to vehicle .
CONCLUSIONS	The study was conducted under controlled conditions in a relatively small population .
CONCLUSIONS	Luliconazole cream 1 % applied once daily for 7 days is more effective than vehicle and well tolerated in patients with tinea cruris .

###24760025
OBJECTIVE	To compare the postoperative analgesic effects of lidocaine , morphine and lidocaine plus morphine administered by constant rate infusion ( CRI ) and analyzing their effects on opioid requirements after orthopedic surgery in dogs .
METHODS	Twenty-four dogs underwent fracture repairs were premedicated with IM acepromazine ( 0.05 mg/kg ) combined with morphine ( 0.3 mg/kg ) .
METHODS	Anesthesia was induced with IV propofol ( 4 to 5 mg / kg ) and maintained with isoflurane .
METHODS	The dogs were randomly assigned to 3 groups and administered a CRI IV of lidocaine ( T-L ) , morphine ( T-M ) or lidocaine plus morphine ( T-LM ) at the same doses .
METHODS	Postoperative analgesia was assessed for 24 hours using a Visual Analog Scale ( VAS ) and the Glasgow Composite Pain Scale ( GCPS ) .
METHODS	Rescue analgesia was performed if the evaluation score exceeded 50 % of the VAS and/or 33 % of the GCPS .
RESULTS	The pain score and postoperative opioid requirements did not differ among the treatments .
RESULTS	Rescue analgesia was administered to 1/8 dogs in the T-M and T-LM , and to 3/8 dogs in the T-L .
CONCLUSIONS	Lidocaine , morphine or lidocaine/morphine CRI may be efficacious techniques for pain management in the first 24 hours post-surgery .
CONCLUSIONS	However , the two drugs administered together did not reduce the postoperative opioid requirement in dogs undergoing fracture repair .
CONCLUSIONS	Key words : Anesthesia .
CONCLUSIONS	Analgesics .
CONCLUSIONS	Analgesics , Opioid .
CONCLUSIONS	Lidocaine .
CONCLUSIONS	Morphine .
CONCLUSIONS	Dogs .

###24685020
BACKGROUND	The risk of cardiovascular diseases ( CVD ) is increased tremendously among menopausal women , and there is an increasing demand for alternative therapies for managing factors like dyslipidemia that contribute to CVD development .
METHODS	In this study , Nigella sativa was evaluated for its hypolipidemic effects among menopausal women .
METHODS	In a randomised trial , hyperlipidemic menopausal women were assigned to treatment ( n = 19 ) or placebo groups ( n = 18 ) , and given N. sativa or placebo for two months after their informed consents were sought .
METHODS	At baseline , blood samples were taken and at one month intervals thereafter until one month after the end of the study .
RESULTS	The results showed that N. sativa significantly improved lipid profiles of menopausal women ( decreased total cholesterol , low density lipoprotein cholesterol and triglyceride , and increased high density lipoprotein cholesterol ) more than the placebo treatment over 2 months of intervention .
RESULTS	One month after cessation of treatment , the lipid profiles in the N. sativa-treated group tended to change towards the pretreatment levels .
CONCLUSIONS	N. sativa is thought to have multiple mechanisms of action and is cost-effective .
CONCLUSIONS	Therefore , it could be used by menopausal women to remedy hypercholesterolemia , with likely more benefits than with single pharmacological agents that may cause side effects .
CONCLUSIONS	The use of N. sativa as an alternative therapy for hypercholesterolemia could have profound impact on the management of CVD among menopausal women especially in countries where it is readily available .

###24428802
BACKGROUND	Overweight and obesity among young , adult women are increasing problems in Sweden as in many other countries .
BACKGROUND	The postpartum period may be a good opportunity to improve eating habits and lose weight in a sustainable manner .
BACKGROUND	The aim was to make a cost-utility analysis of a dietary behavior modification treatment alongside usual care , compared to usual care alone , among lactating overweight and obese women .
METHODS	This study was a cost-utility analysis based on a randomized controlled and longitudinal clinical diet intervention .
METHODS	Between 2007-2010 , 68 women living in Sweden were , after baseline measurement at 8-12weeks postpartum , randomly assigned to a 12-week dietary behavior modification treatment or control group .
METHODS	Inclusion criteria were : self-reported pre-pregnancy body mass index ( BMI ) 25-35kg / m2 , non-smoker , singleton term delivery , birth weight > 2500g , intention to breastfeed for 6 mo and no diseases ( mother and child ) .
METHODS	The women in the intervention group received 1.5 hour of individual counseling at study start and 1 hour at follow-up home visits after 6 weeks of intervention , with support through cell phone text messages every two wk .
METHODS	Dietary intervention aimed to reduce dietary intake by 500kcal/day .
METHODS	The control group received usual care .
METHODS	Weight results have previously been reported .
METHODS	Here we report on analyses carried out during 2012-2013 of cost per quality adjusted life years ( QALY ) , based on the changes in quality of life measured by EQ-5D-3L and SF-6D .
METHODS	Likelihood of cost-effectiveness was calculated using Net Monetary Benefit method .
RESULTS	Based on conservative assumptions of no remaining effect after 1 year follow-up , the diet intervention was cost-effective .
RESULTS	Costs per gained QALY were 8 643 - 9 758 USD .
RESULTS	The likelihood for cost-effectiveness , considering a willingness to pay 50 000 USD for a QALY , was 87-93 % .
CONCLUSIONS	The diet intervention is cost-effective .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01343238 Registered April 27 , 2011 .
BACKGROUND	The regional ethics committee in Gothenburg , Sweden , approved the study on November 15 , 2006 .

###24251428
OBJECTIVE	The energy source used for stone fragmentation is important in miniperc .
OBJECTIVE	In this study , we compared the stone fragmentation characteristics and outcomes of laser lithotripsy and pneumatic lithotripsy in miniperc for renal calculi .
METHODS	After Institutional Review Board approval , 60 patients undergoing miniperc for renal calculi of 15 to 30 mm were equally randomized to laser and pneumatic lithotripsy groups .
METHODS	Miniperc was performed using 16.5 F Karl Storz miniperc sheath and a 12F nephroscope .
METHODS	Laser lithotripsy was performed using a 550-m laser fiber and 30 W laser with variable settings according to the need .
METHODS	Pneumatic lithotripsy was performed using the EMS Swiss lithoclast .
METHODS	Patient demographics , stone characteristics , intraoperative parameters , and postoperative outcomes were analyzed .
RESULTS	The baseline patient demographics and stone characteristics were similar in both groups .
RESULTS	The total operative time ( P = 0.433 ) and fragmentation time ( P = 0.101 ) were similar between the groups .
RESULTS	The surgeon assessed that the Likert score ( 1 to 5 ) for fragmentation was similar in both groups ( 2.1 0.8 vs 1.9 0.9 , P = 0.313 ) .
RESULTS	Stone migration was lower with the laser ( 1.3 0.5 vs 1.7 0.8 , P = 0.043 ) , and fragment removal was easier with the laser ( 1.1 0.3 vs 1.7 1.1 , P = 0.011 ) .
RESULTS	The need for fragment retrieval using a basket was significantly more in the pneumatic lithotripsy group ( 10 % vs 37 % , P = 0.002 ) .
RESULTS	The hemoglobin drop , complication rates , auxiliary procedures , postoperative pain , and stone clearance rates were similar between the groups ( P > 0.2 ) .
CONCLUSIONS	Both laser lithotripsy and pneumatic lithotripsy are equally safe and efficient stone fragmentation modalities in miniperc .
CONCLUSIONS	Laser lithotripsy is associated with lower stone migration and easier retrieval of the smaller fragments it produces .

###24482441
BACKGROUND	The role of nutrition in the treatment of attention-deficit hyperactivity disorder ( ADHD ) is gaining international attention ; however , treatments have generally focused only on diet restriction or supplementing with one nutrient at a time .
OBJECTIVE	To investigate the efficacy and safety of a broad-based micronutrient formula consisting mainly of vitamins and minerals , without omega fatty acids , in the treatment of ADHD in adults .
METHODS	This double-blind randomised controlled trial assigned 80 adults with ADHD in a 1:1 ratio to either micronutrients ( n = 42 ) or placebo ( n = 38 ) for 8 weeks ( trial registered with the Australian New Zealand Clinical Trials Registry : ACTRN12609000308291 ) .
RESULTS	Intent-to-treat analyses showed significant between-group differences favouring active treatment on self - and observer - but not clinician-ADHD rating scales .
RESULTS	However , clinicians rated those receiving micronutrients as more improved than those on placebo both globally and on ADHD symptoms .
RESULTS	Post hoc analyses showed that for those with moderate/severe depression at baseline , there was a greater change in mood favouring active treatment over placebo .
RESULTS	There were no group differences in adverse events .
CONCLUSIONS	This study provides preliminary evidence of efficacy for micronutrients in the treatment of ADHD symptoms in adults , with a reassuring safety profile .

###24725369
BACKGROUND	Patients with stable COPD show improvements in exercise capacity and muscular function after the application of whole body vibration .
BACKGROUND	We aimed to evaluate whether this modality added to conventional physiotherapy in exacerbated hospitalised COPD patients would be safe and would improve exercise capacity and quality of life .
METHODS	49 hospitalised exacerbated COPD patients were randomized ( 1:1 ) to undergo physiotherapy alone or physiotherapy with the addition of whole body vibration .
METHODS	The primary endpoint was the between-group difference of the 6-minute walking test ( day of discharge - day of admission ) .
METHODS	Secondary assessments included chair rising test , quality of life , and serum marker analysis .
RESULTS	Whole body vibration did not cause procedure-related adverse events .
RESULTS	Compared to physiotherapy alone , it led to significantly stronger improvements in 6-minute walking test ( 95.55 76.29 m vs. 6.13 81.65 m ; p = 0.007 ) and St. Georges Respiratory Questionnaire ( -6.43 14.25 vs. 5.59 19.15 , p = 0.049 ) .
RESULTS	Whole body vibration increased the expression of the transcription factor peroxisome proliferator receptor gamma coactivator-1 - and serum levels of irisin , while it decreased serum interleukin-8 .
CONCLUSIONS	Whole body vibration during hospitalised exacerbations did not cause procedure-related adverse events and induced clinically significant benefits regarding exercise capacity and health-related quality of life that were associated with increased serum levels of irisin , a marker of muscle activity .
BACKGROUND	German Clinical Trials Register DRKS00005979 .
BACKGROUND	Registered 17 March 2014 .

###24350813
OBJECTIVE	The purpose of this study was to evaluate the long-term safety and efficacy of risperidone in treating irritability and related behaviors in children and adolescents with autistic disorders .
METHODS	In this 6 month ( 26 week ) open-label extension ( OLE ) study , patients ( 5-17 years of age , who completed the previous fixed-dose , 6 week , double-blind [ DB ] phase ) were flexibly dosed with risperidone based on body weight .
METHODS	The maximum allowed dose was 1.25 mg/day for those weighing 20 to < 45 kg , and 1.75 mg/day for those weighing 45 kg .
METHODS	The study primarily assessed risperidone 's safety ; efficacy was assessed as a secondary end-point .
RESULTS	Fifty-six ( 71 % ) out of 79 enrolled patients completed the OLE ; the most common discontinuations were for insufficient response ( 7 [ 9 % ] ) or adverse events ( AE ) ( 5 [ 6 % ] ) .
RESULTS	The most common ( 5 % frequency in the total group ) AEs were increased appetite ( 11 % [ n = 9 ] ) ; increased weight and vomiting ( 9 % [ n = 7 ] each ) ; sedation , pyrexia , and upper respiratory tract infection ( 8 % [ n = 6 ] each ) ; nasopharyngitis ( 6 % [ n = 5 ] ) ; and somnolence and fatigue ( 5 % [ n = 4 ] each ) .
RESULTS	Extrapyramidal AEs were reported in 6 ( 8 % ) patients .
RESULTS	Increase in mean weight ( 11-15 % ) and body mass index ( 5-10 % ) occurred ; one patient discontinued because of weight increase .
RESULTS	One potentially prolactin-related AE ( irregular menstruation ) was reported .
RESULTS	The risperidone high-dose group had the greatest mean improvement in sleep visual analog scale ( 24.6 ) .
RESULTS	All groups showed additional improvement in efficacy scale scores during the OLE .
CONCLUSIONS	During this OLE , safety findings with risperidone treatment ( maximum weight-based dose of 1.25 mg/day or 1.75 mg/day ) were consistent with those observed in the DB phase , and with the current safety information for risperidone in autistic , psychiatric , and behavioral disorders .
CONCLUSIONS	Patients experienced some additional improvement in irritability and related behaviors .
BACKGROUND	This phase-4 study is registered at ClinicalTrials.gov ( NCT00576732 ) .

###25593121
BACKGROUND	For patients with acute iliofemoral deep vein thrombosis , it remains unclear whether the addition of intravascular high-frequency , low-power ultrasound energy facilitates the resolution of thrombosis during catheter-directed thrombolysis .
RESULTS	In a controlled clinical trial , 48 patients ( mean age 50 21 years , 52 % women ) with acute iliofemoral deep vein thrombosis were randomized to receive ultrasound-assisted catheter-directed thrombolysis ( N = 24 ) or conventional catheter-directed thrombolysis ( N = 24 ) .
RESULTS	Thrombolysis regimen ( 20 mg r-tPA over 15 hours ) was identical in all patients .
RESULTS	The primary efficacy end point was the percentage of thrombus load reduction from baseline to 15 hours according to the length-adjusted thrombus score , obtained from standardized venograms and evaluated by a core laboratory blinded to group assignment .
RESULTS	The percentage of thrombus load reduction was 55 % 27 % in the ultrasound-assisted catheter-directed thrombolysis group and 54 % 27 % in the conventional catheter-directed thrombolysis group ( P = 0.91 ) .
RESULTS	Adjunctive angioplasty and stenting was performed in 19 ( 80 % ) patients and in 20 ( 83 % ) patients , respectively ( P > 0.99 ) .
RESULTS	Treatment-related complications occurred in 3 ( 12 % ) and 2 ( 8 % ) patients , respectively ( P > 0.99 ) .
RESULTS	At 3-month follow-up , primary venous patency was 100 % in the ultrasound-assisted catheter-directed thrombolysis group and 96 % in the conventional catheter-directed thrombolysis group ( P = 0.33 ) , and there was no difference in the severity of the post-thrombotic syndrome ( mean Villalta score : 3.0 3.9 [ range 0-15 ] versus 1.9 1.9 [ range 0-7 ] ; P = 0.21 ) , respectively .
CONCLUSIONS	In this randomized controlled clinical trial of patients with acute iliofemoral deep vein thrombosis treated with a fixed-dose catheter thrombolysis regimen , the addition of intravascular ultrasound did not facilitate thrombus resolution .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01482273 .

###25745750
OBJECTIVE	To compare vaginoscopic hysteroscopic sterilization with traditional hysteroscopic approach for differences in pain , bilateral microinsert placement rates , and procedure time .
METHODS	We performed a prospective , randomized , single-blinded study of hysteroscopic sterilization using the Essure System .
METHODS	The study setting was an inner city ObGyn clinic .
METHODS	Ninety patients were randomized to either vaginoscopy or traditional approach .
METHODS	The traditional approach was speculum insertion , paracervical analgesia , and tenaculum .
METHODS	All procedures were done with a 5 mm , 30 degree rigid hysteroscope .
METHODS	Main outcome measures were pain scores ( 10-point visual analog scale ) , bilateral placement rates , and procedure times .
RESULTS	Vaginoscopy was successful in 42/45 patients ( 93 % ) .
RESULTS	There was no statistically significant difference in pain-scores for microinsert placement between the groups ( p = 0.71 ) .
RESULTS	First attempt , bilateral microinsert placement rate was 95 % ( 40/42 ) with vaginoscopy and 95 % ( 43/45 ) with traditional ( p = 0.89 ) .
RESULTS	Time for treatment completion was 16 minutes ( mean ) ( range , 13-21 ) in the traditional group versus vaginoscopy time of 9 minutes ( mean ) ( range , 7-11 ) ( p = 0.03 ) .
CONCLUSIONS	Hysteroscopic sterilization via vaginoscopy is feasible with bilateral microinsert rates comparable to those of traditional hysteroscopy .
CONCLUSIONS	Vaginoscopy is associated with less overall discomfort and is faster to perform .

###24820727
BACKGROUND	To study sevoflurane inhalation general anesthesia using the laryngeal mask airway ( LMA ) and nasal endotracheal ( ET ) intubation to maintain the airway in pediatric day-case dental surgery .
METHODS	A total of 171 children aged 2 to 7 years received elective day-case dental surgical procedure under general anesthesia .
METHODS	Children were randomly grouped into LMA groups ( L ) and nasal ET intubation group ( N ) .
METHODS	In L groups , LMA was inserted after induction of anesthesia using 8 % sevoflurane and were allowed to breathe spontaneously .
METHODS	Rocuronium and remifentanil were given intravenously during 8 % sevoflurane induction by nasal ET intubation in the N group .
METHODS	The time of anesthetic induction , maintenance , recovery , surgical access , and bispectral index score were recorded .
METHODS	Postoperative nausea and vomiting and the incidence of adverse events during induction and recovery period were also recorded .
RESULTS	The insertion time of LMA was significantly shorter than nasal ET ( P < 0.05 ) .
RESULTS	The incidence of airway complications , the surgeons ' access , and bispectral index were not different between the 2 groups .
RESULTS	However , recovery time was significantly shorter in group L ( P < 0.05 ) .
RESULTS	The incidence of sore throat and postoperative nausea and vomiting ( P < 0.01 ) were much less in group L as well .
CONCLUSIONS	Sevoflurane inhalation anesthesia through LMA is a safe and reliable method for pediatric day-case dental surgery .

###24354714
BACKGROUND	Keloids are a burden for patients due to physical , aesthetic and social complaints and treatment remains a challenge because of therapy resistance and high recurrence rates .
BACKGROUND	The main goal of treatment is to improve the quality of life ( QoL ) ; this implies that , apart from surgical outcomes , patient-reported outcome measures ( PROMs ) need to be taken into account .
BACKGROUND	Decision making in keloid treatment is difficult due to heterogeneity of the condition and the lack of comparative studies .
METHODS	This is a multicentre , randomised controlled open trial that compares 1 ) intralesional cryotherapy versus excision and corticosteroids for primary keloids , and 2 ) intralesional cryotherapy versus excision and brachytherapy for therapy-resistant keloids .
METHODS	The primary outcome is the Patient and Observer Scar Assessment Scale ( POSAS ) , a 12-item scale ( with score 12 indicating the best and 120 indicating the worst scar imaginable ) .
METHODS	A difference of six points on the total score is considered to be of clinical importance .
METHODS	Secondary outcomes are recurrence rates , volume reduction , Skindex-29 scores , SF-36 scores and complication rates .
METHODS	Primary and secondary outcome measurements are taken at baseline , and at 2 , 12 , 26 and 52 weeks postoperatively .
METHODS	For analysis , a linear mixed model is used .
METHODS	A total of 176 patients will be included over a period of 2.5 years .
METHODS	The protocol is approved by the Medical Ethics Committee of the Erasmus University Medical Centre Rotterdam and follows good clinical practice guidelines .
CONCLUSIONS	The outcomes of this study will improve evidence-based decision making for the treatment of keloids , as well as patient education .
BACKGROUND	Dutch Trial Register NTR4151 .

###24405891
BACKGROUND	The prevalence of depression is high and the elderly have an increased risk of developing chronic course .
BACKGROUND	International data suggest that depression in the elderly is under-recognised , the latency before clinicians provide a treatment plan is longer and elderly patients with depression are not offered psychotherapy to the same degree as younger patients .
BACKGROUND	Although recommendations for the treatment of elderly patients with depression exist , health-care professionals adhere to these recommendations to a limited degree only .
BACKGROUND	We conducted a systematic review to identify recommendations for managing depression in the elderly and prioritised six recommendations .
BACKGROUND	We identified and prioritised the determinants of practice related to the implementation of these recommendations in primary care , and subsequently discussed and prioritised interventions to address the identified determinants .
BACKGROUND	The objective of this study is to evaluate the effectiveness of these tailored interventions for the six recommendations for the management of elderly patients with depression in primary care .
METHODS	We will conduct a pragmatic cluster randomised trial comparing the implementation of the six recommendations using tailored interventions with usual care .
METHODS	We will randomise 80 municipalities into one of two groups : an intervention group , to which we will deliver tailored interventions to implement the six recommendations , and a control group , to which we will not deliver any intervention .
METHODS	We will randomise municipalities rather than patients , individual clinicians or practices , because we will deliver the intervention for the first three recommendations at the municipal level and we want to minimise the risk of contamination across GP practices for the other three recommendations .
METHODS	The primary outcome is the proportion of actions taken by GPs that are consistent with the recommendations .
CONCLUSIONS	This trial will investigate whether a tailored implementation approach is an effective strategy for improving collaborative care in the municipalities and health-care professionals ' practice towards elderly patients with depression in primary care .
CONCLUSIONS	The effectiveness evaluation described in this protocol will be accompanied with a process evaluation exploring why and how the interventions were effective or ineffective .
BACKGROUND	ClinicalTrials.gov : NCT01913236 .

###24595714
BACKGROUND	The objective of this study was to use a randomized controlled trial design to test the impact of an educational intervention delivered by specially trained community health workers among Chinese , Korean , and Vietnamese participants ages 50 to 75 years on knowledge , attitudes , beliefs , and intentions regarding colorectal cancer screening .
METHODS	Baseline data were collected on participants ' demographic characteristics , knowledge , attitudes , beliefs about cancer , its risk factors , and intention to keep up to date on cancer screening in the future .
METHODS	Fifteen intervention sessions were held between April and June of 2011 .
METHODS	Follow-up surveys were administered in the postintervention period to both intervention and control participants .
METHODS	Those randomized to the control group received educational pamphlets in their native language .
RESULTS	The intervention had the greatest influence on the Chinese subgroup , which had improved scores relative to the control group for perceived behavior control and intentions ( preintervention vs postintervention change : control group , -0.16 ; intervention group , 0.11 ; P = .004 ) , behavioral beliefs on cancer screening ( preintervention vs postintervention change : control group , -0.06 ; intervention group , 0.24 ; P = .0001 ) , and attitudes toward behavior ( preintervention vs postintervention change : control group , -0.24 ; intervention group , 0.35 ; P .0001 ) .
RESULTS	The intervention had no effect on behavioral beliefs about cancer , control beliefs , or perceived behavioral control ( reliance on family ) .
RESULTS	Although the intention to stay up to date for cancer screening increased in 2 study groups ( Chinese and Vietnamese ) , these increases were not significant .
CONCLUSIONS	An educational program delivered by culturally specific community health educators using culturally appropriate language influences some knowledge , attitude , and behavioral beliefs but not others .

###24750284
BACKGROUND	Dumping syndrome is characterized by distinct pathophysiological features such as postprandial increase in hematocrit ( HT ) and pulse rate ( PR ) and delayed hypoglycemia ( HG ) .
BACKGROUND	Treatment is based on dietary measures and somatostatin analogs ( SA ) , but current SAs have incomplete efficacy , possibly through limited affinity for various somatostatin receptor subtypes .
BACKGROUND	We evaluated the effect of pasireotide , a novel SA with high affinity for 4/5 human somatostatin receptors , on pathophysiological events and symptoms in dumping .
METHODS	Randomized double-blind placebo-controlled cross-over study of nine patients ( six women , 474years ) with postoperative dumping .
METHODS	Baseline measurements included oral glucose tolerance testing ( OGTT ) , abdominal ultrasound , and dumping symptom severity score ( DSSS ) .
METHODS	Patients were treated for 2weeks with placebo or pasireotide 300g s.c. t.i.d. with a 1-week wash-out in a randomized fashion .
METHODS	On day 13 and 14 of each treatment OGTT , DSSS , and solid and liquid gastric emptying ( GE ) were obtained .
RESULTS	Baseline OGTT was pathological in all patients based on PR ( n = 5 ) , HT ( n = 1 ) or HG ( n = 7 ) .
RESULTS	Compared to placebo , pasireotide suppressed the increase in PR ( 17.12.8 vs 8.23.5 bpm ; p < 0.05 ) and late HG ( nadir glycemia 55.64.3 vs 83.39.5 mg/dL ; p = 0.007 ) , increased peak glycemia ( 294.133.3 vs 221.023.1 mg/dL ; p = 0.001 ) and delayed GE of solids ( t1/2 8323 vs 439min ; p = 0.05 ) and liquids ( t1/2 7010 vs 404min , p = 0.05 ) .
RESULTS	The differences in DSSS did not reach statistical significance .
RESULTS	Two patients dropped out because of adverse gastrointestinal events under pasireotide .
CONCLUSIONS	Pasireotide affects pathophysiological features of both early and late dumping syndrome .

###24364174
OBJECTIVE	The aim of the present double-blind , randomized , controlled study was to evaluate and compare the efficacy of amnion allograft and connective tissue graft in covering denuded root surfaces .
METHODS	Seventy-one teeth in 22 patients with gingival recession were treated randomly with coronally displaced flap plus connective tissue graft ( control group , n = 29 recessions in 10 patients ) or coronally displaced flap plus amnion allograft ( test group , n = 42 recessions in 12 patients ) .
METHODS	The amount of root coverage and clinical parameters ( probing depth , recession depth , clinical attachment level , recession width , gingival width , and papilla dimensions ) were measured at baseline and at 3 and 6 months postoperatively .
RESULTS	Average root coverage percentages after 6 months in the test and control groups were 67 % ( 2.3 + / - 0.289 mm ) and 54 % ( 2.24 + / - 0.519 mm ) , respectively , with no statistically significant differences ( p = 0.054 ) .
RESULTS	The changes in depth and width of recessions and in gingival width were significant 3 and 6 months after surgery compared to baseline ( p = 0.000 ) .
RESULTS	Variations in the level of attachment and probing depths after 6 months were statistically significant in the test group compared to the control group ( p = 0.002 ) .
RESULTS	Papilla dimensions were significantly correlated with root coverage ( p = 0.00 ) .
CONCLUSIONS	Amnion allograft might be a suitable alternative to connective tissue graft in procedures to cover denuded root surfaces and can reduce recession depth .

###25117997
OBJECTIVE	Based on the growing evidence of risk reduction from fresh fruit and vegetable consumption and an inverse relationship between serum 25-hydroxyvitamin D ( 25OHD ) and the risk of type 2 diabetes ( T2D ) , we determined the benefits of regularly consuming vitamin D-enriched mushrooms in a prediabetic cohort .
OBJECTIVE	Exposing edible mushrooms to ultraviolet B ( UVB ) light increases vitamin D2 ( D2 ) and raises serum 25OHD2 in healthy young adults ; however , their benefit to deficient prediabetics and glucose metabolism remains untested .
METHODS	Forty-three prediabetic , D-deficient adults ( 25OHD20ng/ml ) , BMI > 25 were randomized to four groups consuming daily entres containing 100g fresh sliced cooked mushrooms prepared by a chef for 16 weeks .
METHODS	Two groups were fed UVB-treated mushrooms initially containing : 600IU D2 or 4000IU D2 ; each one also received one capsule of placebo daily .
METHODS	Two control groups were fed untreated mushrooms and D3 dietary supplements at two label doses : 600IU D3 and 4000IU D3 .
METHODS	D2 and D3 content were analyzed in mushrooms , before and after cooking and in over-the-counter supplements .
RESULTS	After 16 weeks , both D2-UVB-mushroom entre doses , which were significantly lower after cooking , produced modest or no increases in 25OHD2 or total 25OHD relative to the positive control subjects who actually consumed about 1242 and 7320IU per day of D3 ( higher than stated on the label ) .
CONCLUSIONS	Unanticipated D2 cooking loss from fresh UVB mushrooms and probable low absorption and/or hydroxylation may explain the smaller increase in 25OHD2 in our prediabetic overweight/obese cohort compared with past findings in younger , healthy subjects .
CONCLUSIONS	Moreover , no dose or vitamin D source was associated with modifying T2D risk factors .

###24416321
OBJECTIVE	To investigate the relationship between breastfeeding and snoring in childhood .
METHODS	In a cohort of children with a family history of asthma who were recruited antenatally we prospectively recorded data on infant feeding practices throughout the first year of life .
METHODS	Snoring status and witnessed sleep apnea were measured at age 8 years by parent-completed questionnaire .
METHODS	Associations were estimated by logistic regression with , and without , adjustment for sets of confounders designed to exclude biasing effects .
RESULTS	Habitual snoring was reported in 18.8 % of the sample , and witnessed apnea in 2.7 % .
RESULTS	Any breastfeeding for longer than one month was associated with a reduced risk of habitual snoring at age 8 ( adjusted OR 0.48 , 95 % CI 0.29 to 0.81 ) and duration of breastfeeding was inversely associated with the prevalence of habitual snoring ( adjusted OR 0.79 , 95 % CI 0.62 to 1.00 ) .
RESULTS	Any breastfeeding for longer than 1 month was associated with a lower risk of witnessed sleep apnea ( adjusted OR 0.17 , 95 % CI 0.04 to 0.71 ) .
RESULTS	The protective associations were not mediated by BMI , current asthma , atopy or rhinitis at age 8 years .
CONCLUSIONS	Breastfeeding for longer than one month decreases the risk of habitual snoring and witnessed apneas in this cohort of children with a family history of asthma .
CONCLUSIONS	The underlying mechanism remains unclear but the finding would be consistent with a beneficial effect of the breast in the mouth on oropharyngeal development with consequent protection against upper airway dysfunction causing sleep-disordered breathing .

###25026866
OBJECTIVE	The purpose of this study was to assess accuracy of lung nodule volumetry in low-dose CT with application of iterative reconstruction ( IR ) according to nodule size , nodule density and CT tube currents , using artificial lung nodules within an anthropomorphic thoracic phantom .
METHODS	Eight artificial nodules ( four diameters : 5 , 8 , 10 and 12 mm ; two CT densities : -630 HU that represents ground-glass nodule and +100 HU that represents solid nodule ) were randomly placed inside a thoracic phantom .
METHODS	Scans were performed with tube current-time product to 10 , 20 , 30 and 50 mAs .
METHODS	Images were reconstructed with IR and filtered back projection ( FBP ) .
METHODS	We compared volume estimates to a reference standard and calculated the absolute percentage error ( APE ) .
RESULTS	The APE of all nodules was significantly lower when IR was used than with FBP ( 7.5 4.7 % compared with 9.0 6.9 % ; p < 0.001 ) .
RESULTS	The effect of IR was more pronounced for smaller nodules ( p < 0.001 ) .
RESULTS	IR showed a significantly lower APE than FBP in ground-glass nodules ( p < 0.0001 ) , and the difference was more pronounced at the lowest tube current ( 11.8 5.9 % compared with 21.3 6.1 % ; p < 0.0001 ) .
RESULTS	The effect of IR was most pronounced for ground-glass nodules in the lowest CT tube current .
CONCLUSIONS	Lung nodule volumetry in low-dose CT by application of IR showed reliable accuracy in a phantom study .
CONCLUSIONS	Lung nodule volumetry can be reliably applicable to all lung nodules including small , ground-glass nodules even in ultra-low-dose CT with application of IR .
CONCLUSIONS	IR significantly improved the accuracy of lung nodule volumetry compared with FBP particularly for ground-glass ( -630 HU ) nodules .
CONCLUSIONS	Volumetry in low-dose CT can be utilized in patient with lung nodule work-up , and IR has benefit for small , ground-glass lung nodules in low-dose CT. .

###25371633
OBJECTIVE	To evaluate the anatomical and functional efficacy of combination therapy of intravitreal ranibizumab with laser or intravitreal bevacizumab with laser treatment compared to only laser treatment for macular edema due to branch retinal vein occlusion ( BRVO ) .
METHODS	Thirty eyes of 30 patients with BRVO of at least 6 weeks duration were randomized into three groups : Group 1 received a single dose of intravitreal Ranibizumab followed by grid laser treatment , Group 2 received a single dose of intravitreal Bevacizumab followed by grid laser treatment , and Group 3 received grid laser alone .
METHODS	Outcomes at 6 months follow-up were reported .
METHODS	Data were collected on best corrected visual acuity ( BCVA ) , central foveal thickness ( CFT ) , and gain in lines of Snellen acuity .
RESULTS	At 6 month follow-up , the difference in the mean BCVA and CFT between the three treatment groups was not statistically significant ( P > 0.05 , all comparisons ) .
RESULTS	Six eyes ( 60 % ) in Group 1 , four eyes ( 40 % ) in Group 2 and two eyes ( 20 % ) in Group 3 had a statistically significant gain of 3 lines of Snellen acuity ( P < 0.05 ) .
CONCLUSIONS	Both ranibizumab and bevacizumab combined with laser photocoagulation , resulted in better outcomes than grid laser treatment .

###24456239
OBJECTIVE	Tubeless percutaneous nephrolithotoomy ( PCNL ) , although an accepted technique by now , continues to suffer from two major limitations : The need for postoperative cystoscopy for ureteral stent removal and inability to perform a `` second-look '' procedure for any residual fragments .
OBJECTIVE	We share our experience with a modification of the standard tubeless PCNL technique that allows us to overcome these shortcomings .
METHODS	A total of 166 patients selected to have PCNL were randomized into two groups of 83 each .
METHODS	In group A ( control group ) , the patients underwent standard PCNL with the insertion of a nephrostomy tube at completion ; in group B ( intervention group ) , modified tubeless PCNL was performed with a Double-J ( DJ ) stent inserted with a tether attached to its proximal end , taken out through the percutaneous tract .
METHODS	The nephrostomy tube in group A was removed postoperatively on the second or third day , whereas those in group B had the stent removed directly by pulling the attached tether within the office setting 10 to 14 days postoperatively .
RESULTS	The need for postoperative analgesia was significantly higher in group A compared with group B ( mean dose of tramadol needed , 128 mg vs 81.3 mg ) ( P < 0.001 ) .
RESULTS	Four patients in group A had postoperative urinary leakage from the nephrostomy site , whereas there were no leaks in patients in group B. Group B patients spent significantly shorter average time in hospital ( 21.6 hours ) compared with group A ( 54 hours ) ( P < 0.001 ) .
RESULTS	Two of the patients in group B needed a second-look procedure , performed by the insertion of a guidewire down the stent , which was pulled out partially by its tether .
RESULTS	Presence of the tether in the flank or the process of subsequent removal did not cause any discomfort to any patient .
CONCLUSIONS	The present study demonstrates that tubeless PCNL with a tethered DJ stent overcomes its main drawback , namely , the need for cystoscopy for stent removal , and also allows access to the pelvicaliceal system for second-look nephroscopy .

###25297058
BACKGROUND	The Y-75 ( Ginsan ) acidic polysaccharide from Korean Panax ginseng has been shown to function as an immunomodulatory molecule .
BACKGROUND	However , the efficacy of Y-75 has not been evaluated in clinical trial .
METHODS	We verified Y-75 ( 6 g/day ) for safety and immune efficacy in 72 healthy volunteers aged 50-75 years using a randomized , placebo-controlled , parallel , double-blind study .
METHODS	The activities of natural killer ( NK ) cells and peripheral blood phagocytes , as well as serum levels of monocyte-derived mediators , were assessed before and after administration for 8 and 14 weeks .
METHODS	This trial is registered at ClinicalTrials.gov ( NCT02161198 ) .
RESULTS	Y-75 significantly enhanced NK cell cytotoxic activity by 35.2 % and 40.2 % from baseline after administration for 8 and 14 weeks , respectively .
RESULTS	The phagocytic activity of peripheral blood cells was also significantly increased by 25.2 % and 39.4 % and serum level of TNF - by 38.2 % and 44.5 % after treatment for 8 and 14 weeks , respectively .
RESULTS	Differences in the efficacy of variables compared to the placebo group were also significant .
RESULTS	Administration of Y-75 was well tolerated without treatment-related adverse events or alteration of complete blood cell count or blood chemistry over the entire study period .
CONCLUSIONS	Y-75 was shown to be a safe and potentially effective natural alternative for enhancing immune function .

###24451696
OBJECTIVE	To evaluate the chronic effects of a static stretching program on the muscle architecture of biceps femoris ( BF ) and vastus lateralis ( VL ) muscles in ultrasound ( US ) images .
METHODS	Randomized controlled longitudinal trial .
METHODS	Biomechanics Laboratory of Physical Education School of the Army , Rio de Janeiro , Brazil .
METHODS	The study included 24 healthy and physically active male volunteers ( 19.05 1.40 years , 1.73 0.07 m , and 73.15 8.33 kg ) , randomly allocated to 1 of 2 groups : stretching group ( SG , n = 12 ) and control group ( n = 12 ) .
METHODS	The SG was submitted to 3 sets of 30 seconds of static stretching 3 times a week during 8 weeks .
METHODS	Ultrasound equipment ( 7.5 MHz ) was used for the evaluation of BF and VL muscle architecture variables ( pennation angle , fiber length , muscle thickness , and fascicle displacement ) before and after training .
METHODS	Knee range of motion ( ROM ) and isometric flexion and extension torque ( TQ ) were also measured .
RESULTS	There were no significant changes in muscle architecture , TQ , and maximum knee flexion angle ( P > 0.05 ) .
RESULTS	However , maximum knee extension angle ( MEA ) increased significantly in the SG ( pretraining : 159.37 7.27 degrees and posttraining : 168.9 3.7 degrees ; P < 0.05 ) .
CONCLUSIONS	Volume or intensity ( or both ) of the stretching protocol was insufficient to cause structural changes in the VL and BF muscles .
CONCLUSIONS	The increase in MEA could not be explained by muscle architecture changes .
CONCLUSIONS	To describe changes in the VL and BF muscle tendon unit using US after a long-term stretching program to identify which structures are responsible for ROM increase .

###24488498
OBJECTIVE	To evaluate the influence of low-dose , enteric-coated aspirin tablets ( 100mg/day for 2years ) on colorectal tumour recurrence in Asian patients with single/multiple colorectal tumours excised by endoscopy .
METHODS	A double-blinded , randomised , placebo-controlled multicentre clinical trial was conducted .
METHODS	311 subjects with single/multiple colorectal adenomas and adenocarcinomas excised by endoscopy were enrolled in the study ( 152 patients in the aspirin group and 159 patients in the placebo group ) .
METHODS	Enrolment began at the hospitals ( n = 19 ) in 2007 and was completed in 2009 .
RESULTS	The subjects treated with aspirin displayed reduced colorectal tumourigenesis and primary endpoints with an adjusted OR of 0.60 ( 95 % CI 0.36 to 0.98 ) compared with the subjects in the placebo group .
RESULTS	Subgroup analysis revealed that subjects who were non-smokers , defined as those who had smoked in the past or who had never smoked , had a marked reduction in the number of recurrent tumours in the aspirin-treated group .
RESULTS	The adjusted OR for aspirin treatment in non-smokers was 0.37 ( CI 0.21 to 0.68 , p < 0.05 ) .
RESULTS	Interestingly , the use of aspirin in smokers resulted in an increased risk , with an OR of 3.44 .
RESULTS	In addition , no severe adverse effects were observed in either group .
CONCLUSIONS	Low-dose , enteric-coated aspirin tablets reduced colorectal tumour recurrence in an Asian population .
CONCLUSIONS	The results are consistent with those obtained from other randomised controlled trials in Western countries .
CONCLUSIONS	THE CLINICAL TRIAL REGISTRY WEBSITE AND THE CLINICAL TRIAL NUMBER : http://www.umin.ac.jp ( number UMIN000000697 ) .

###24386906
BACKGROUND	Lung cancer is the leading cause of cancer death worldwide and characterized by a poor prognosis .
BACKGROUND	It has a major impact on the psychological wellbeing of patients and their partners .
BACKGROUND	Recently , it has been shown that Mindfulness-Based Stress Reduction ( MBSR ) is effective in reducing anxiety and depressive symptoms in cancer patients .
BACKGROUND	The generalization of these results is limited since most participants were female patients with breast cancer .
BACKGROUND	Moreover , only one study examined the effectiveness of MBSR in partners of cancer patients .
BACKGROUND	Therefore , in the present trial we study the effectiveness of MBSR versus treatment as usual ( TAU ) in patients with lung cancer and their partners .
METHODS	A parallel group , randomized controlled trial is conducted to compare MBSR with TAU .
METHODS	Lung cancer patients who have received or are still under treatment , and their partners are recruited .
METHODS	Assessments will take place at baseline , post intervention and at three-month follow-up .
METHODS	The primary outcome is psychological distress ( i.e. anxiety and depressive symptoms ) .
METHODS	Secondary outcomes are quality of life ( only for patients ) , caregiver appraisal ( only for partners ) , relationship quality and spirituality .
METHODS	In addition , cost-effectiveness ratio ( only in patients ) and several process variables are assessed .
CONCLUSIONS	This trial will provide information about the clinical and cost-effectiveness of MBSR compared to TAU in patients with lung cancer and their partners .

###24903544
BACKGROUND	Photodynamic therapy ( PDT ) is approved for selected nodular basal cell carcinomas ( nBCC ) but efficacy is reduced for large and thick tumours .
BACKGROUND	Ablative fractional lasers ( AFXL ) facilitate uptake of methyl aminolaevulinate ( MAL ) and may thus improve PDT outcome .
OBJECTIVE	To evaluate efficacy and safety of AFXL-mediated PDT ( AFXL-PDT ) compared with conventional PDT of high-risk nBCC .
METHODS	Patients with histologically verified facial nBCC ( n = 32 ) defined as high-risk tumours were included ; diameter > 15mm , tumours located in high-risk zones , or on severely sun-damaged skin .
METHODS	Tumours were debulked and patients randomized to either AFXL-PDT ( n = 16 ) or PDT ( n = 16 ) .
METHODS	Fractional CO2 laser treatment was applied at 5 % density and 1000m ( 80mJ ) ablation depth .
METHODS	MAL was applied under occlusion for 3h and illuminated with a 633-nm light-emitting diode source , 37Jcm ( -2 ) .
METHODS	Clinical assessments were performed at 3 , 6 , 9 and 12months and biopsies were taken at 12months .
RESULTS	Clinical cure rates at 3months were 100 % ( 16 of 16 AFXL-PDT ) and 88 % ( 14 of 16 PDT , P = 0484 ) .
RESULTS	Recurrences tended to occur later and in lower numbers after AFXL-PDT at 6 , 9 and 12months ( 6 % , 19 % , 19 % ) than PDT ( 25 % , 38 % , 44 % ) ( P = 0114 ) .
RESULTS	Histology at 12months documented equal tumour clearance after AFXL-PDT ( 63 % , 10 of 16 ) and PDT ( 56 % , 9 of 16 ) .
RESULTS	Cosmetic outcomes were highly satisfactory after both treatments ( P > 0090 ) .
CONCLUSIONS	Long-term efficacy was similar after PDT and AFXL-PDT with a trend for a favourable short-term cure rate after AFXL-PDT .
CONCLUSIONS	AFXL-PDT needs further refinement for nBCC and at present is not recommended over PDT .

###25102384
OBJECTIVE	To examine the effects of activity-based therapy ( ABT ) on neurologic function , walking ability , functional independence , metabolic health , and community participation .
METHODS	Randomized controlled trial with delayed treatment design .
METHODS	Outpatient program in a private , nonprofit rehabilitation hospital .
METHODS	Volunteer sample of adults ( N = 48 ; 37 men and 11 women ; age , 18-66y ) with chronic ( 12mo postinjury ) , motor-incomplete ( ASIA Impairment Scale grade C or D ) spinal cord injury ( SCI ) .
METHODS	A total of 9h/wk of ABT for 24 weeks including developmental sequencing ; resistance training ; repetitive , patterned motor activity ; and task-specific locomotor training .
METHODS	Algorithms were used to guide group allocation , functional electrical stimulation utilization , and locomotor training progression .
METHODS	Neurologic function ( International Standards for Neurological Classification of Spinal Cord Injury ) ; walking speed and endurance ( 10-meter walk test , 6-minute walk test , and Timed Up and Go test ) ; community participation ( Spinal Cord Independence Measure , version III , and Reintegration to Normal Living Index ) ; and metabolic function ( weight , body mass index , and Quantitative Insulin Sensitivity Check ) .
RESULTS	Significant improvements in neurologic function were noted for experimental versus control groups ( International Standards for Neurological Classification of Spinal Cord Injury total motor score [ 5.16.3 vs 0.95.0 ; P = .024 ] and lower extremity motor score [ 4.25.2 vs -0.64.2 ; P = .004 ] ) .
RESULTS	Significant differences between experimental and control groups were observed for 10-meter walk test speed ( 0.0960.14 m/s vs 0.0270.10 m/s ; P = .036 ) and 6-minute walk test total distance ( 35.9748.2 m vs 3.025.5 m ; P = .002 ) .
CONCLUSIONS	ABT has the potential to promote neurologic recovery and enhance walking ability in individuals with chronic , motor-incomplete SCI .
CONCLUSIONS	However , further analysis is needed to determine for whom ABT is going to lead to meaningful clinical benefits .

###24973959
BACKGROUND	Patients with recurrent and/or metastatic ( R/M ) head and neck squamous cell carcinoma ( HNSCC ) receiving platinum-based chemotherapy as their first-line treatment have a dismal prognosis , with a median overall survival ( OS ) of ~ 7 months .
BACKGROUND	Methotrexate is sometimes used following platinum failure or in patients not fit enough for platinum therapy , but this agent has not demonstrated any OS improvement .
BACKGROUND	Targeted therapies are a novel approach , with the EGFR-targeting monoclonal antibody cetuximab ( plus platinum-based chemotherapy ) approved in the US and Europe in the first-line R/M setting , and as monotherapy following platinum failure in the US .
BACKGROUND	However , there is still a high unmet medical need for new treatments that improve outcomes in the second-line R/M setting following failure on first-line platinum-containing regimens .
BACKGROUND	Afatinib , an irreversible ErbB family blocker , was recently approved for the first-line treatment of EGFR mutation-positive metastatic non-small cell lung cancer .
BACKGROUND	Afatinib has also shown clinical activity similar to cetuximab in a Phase II proof-of-concept HNSCC trial .
BACKGROUND	Based on these observations , the Phase III , LUX-Head & Neck 1 study is evaluating afatinib versus methotrexate in R/M HNSCC patients following progression on platinum-based chemotherapy in the R/M setting .
METHODS	Patients with progressive disease after one first-line platinum-based chemotherapy are randomised 2:1 to oral afatinib ( starting dose 40 mg once daily ) or IV methotrexate ( starting dose 40 mg/m ( 2 ) once weekly ) administered as monotherapy with best supportive care until progression or intolerable adverse events .
METHODS	Efficacy of afatinib versus methotrexate will be assessed in terms of progression-free survival ( primary endpoint ) .
METHODS	Disease progression will be evaluated according to RECIST v1 .1 by investigator and independent central review .
METHODS	Secondary endpoints include OS , tumour response and safety .
METHODS	Health-related quality of life and biomarker assessments will also be performed .
CONCLUSIONS	If the LUX-Head & Neck 1 trial meets its primary endpoint , it will demonstrate the ability of afatinib to elicit an improved treatment benefit versus a commonly used chemotherapy agent in the second-line treatment of R/M HNSCC patients who have failed on first-line platinum-based therapy , confirm the clinical efficacy of afatinib observed in the Phase II proof-of-concept study , and establish a new standard of care for this patient population .

###24779956
OBJECTIVE	The present randomized controlled trial evaluated the impact of different exercise training modalities on functional fitness responses in apparently healthy older men .
METHODS	A total of 59 community-dwelling older men were randomly assigned to an aerobic training group ( ATG , n = 19 ) , a combined aerobic and resistance training group ( CTG , n = 20 ) or a control group ( n = 20 ) .
METHODS	Both exercise training programs were moderate-to-vigorous intensity , 3 days/week for 9 months .
METHODS	Six independent functional fitness tests ( back scratch , chair sit-and-reach , 30-s chair stand , arm curl , 8-ft up-and-go , 6-min walk ) were measured on five different occasions .
METHODS	The data were analyzed using a mixed-model ANOVA .
RESULTS	ANOVA showed a significant main effect of group ( P < 0.001 ) for all functional fitness tests , with significant differences between both training groups and controls .
RESULTS	However , the ATG only improved the chair sit-and-reach and the 30-s chair stand performance , whereas CTG improved in all functional fitness tests .
RESULTS	ANOVA also identified a significant main effect of time for 8-ft up-and-go ( P = 0.031 ) in the CTG .
CONCLUSIONS	Only the combined exercise program was effective in improving all functional fitness components related to daily living activities .

###24673496
OBJECTIVE	Luseogliflozin is a selective sodium glucose cotransporter 2 inhibitor under development for the treatment of type 2 diabetes mellitus ( T2DM ) .
OBJECTIVE	This phase II study was conducted to confirm the efficacy and safety of luseogliflozin monotherapy at doses of up to 10mg in Japanese patients with T2DM .
METHODS	Patients with hemoglobin A1c ( HbA1c ) of 6.9-10 .5 % on diet therapy were randomized in a double-blind manner to treatment with 1 , 2.5 , 5 , or 10mg luseogliflozin or placebo for 12 weeks ( n = 56 , 56 , 54 , 58 , and 58 , respectively ) .
BACKGROUND	Japan Pharmaceutical Information Center ( identifier : Japic CTI-101191 ) .
METHODS	The primary endpoint was the change in HbA1c from baseline to the end of treatment .
METHODS	Other endpoints included fasting plasma glucose ( FPG ) , postprandial plasma glucose ( PPG ) and body weight .
METHODS	Adverse events were recorded throughout the study .
RESULTS	HbA1c decreased significantly at the end of treatment in the 1 , 2.5 , 5 , and 10mg luseogliflozin groups compared with placebo ( -0.29 , -0.39 , -0.46 , and -0.43 % , respectively , versus +0.22 % ; all P < 0.001 ) , as did FPG and PPG ( all P < 0.001 ) .
RESULTS	Body weight also decreased significantly in all luseogliflozin groups compared with placebo ( all P < 0.001 ) .
RESULTS	The incidence rates of adverse events ( 40.0-50 .0 % ) were not significantly different among the five groups .
RESULTS	The overall incidence of hypoglycemia was low .
RESULTS	Limitations of this study include the short study duration and the relatively small sample size .
CONCLUSIONS	In Japanese patients with T2DM , luseogliflozin was well tolerated , improved glycemic control , and reduced body weight over 12 weeks of treatment at all tested doses .
CONCLUSIONS	Doses of 2.5 mg achieved similar improvements in glycemic control .

###25284162
OBJECTIVE	The Individual Placement and Support ( IPS ) approach is an evidence-based form of supported employment for people with severe and persistent mental illness .
OBJECTIVE	This approach is not yet widely available in Australia even though there is mounting evidence of its generalisability outside the USA .
OBJECTIVE	One previous Australian randomised controlled trial found that IPS is effective for young people with first episode psychosis .
OBJECTIVE	The aim of the current trial was to assess the effectiveness of evidence-based supported employment when implemented for Australian adult consumers of public mental health services by utilising existing service systems .
METHODS	A four-site randomised control trial design ( n = 208 ) was conducted in Brisbane ( two sites ) , Townsville and Cairns .
METHODS	The intervention consisted of an IPS supported employment service hosted by a community mental health team .
METHODS	The control condition was delivered at each site by mental health teams referring consumers to other disability employment services in the local area .
RESULTS	At 12 months , those in the IPS condition had 2.4 times greater odds of commencing employment than those in the control condition ( 42.5 % vs. 23.5 % ) .
RESULTS	The conditions did not differ on secondary employment outcomes including job duration , hours worked , or job diversity .
RESULTS	Attrition was higher than expected in both conditions with 28.4 % completing the baseline interview but taking no further part in the study .
CONCLUSIONS	The results support previous international findings that IPS-supported employment is more effective than non-integrated supported employment .
CONCLUSIONS	IPS can be successfully implemented this way in Australia , but with a loss of effect strength compared to previous USA trials .

###24675910
BACKGROUND	Compared to eccentric contractions , concentric contractions result in higher cardiovascular stress .
BACKGROUND	However , we do not know how these two types of contractions influence cardiac autonomic modulation during the post-exercise recovery period .
OBJECTIVE	to compare the effect of resistance training that is performed with concentric vs. eccentric emphasis on muscle strength and on post-exercise recovery which was assessed by examining heart rate variability ( HRV ) , for the knee extensor muscle group in young healthy adults .
METHODS	For this study , 105 men between 18 and 30 years of age were randomized into 4 groups : concentric control ( CONCC ) , eccentric control ( ECCC ) , concentric training ( CONCT ) and eccentric training ( ECCT ) .
METHODS	The CONCC and ECCC groups underwent one session of resistance exercise ( RE ) using the knee extensor muscle group ( 3 sets of 1 repetition at 100 % of the maximal repetition [ 1MR ] ) and the CONCT and ECCT groups performed 10 training sessions .
METHODS	The HRV was analyzed at baseline and across four recovery periods ( T1 , T2 , T3 and T4 ) .
RESULTS	The ECCT group exhibited increased muscle strength at the end of the study .
RESULTS	Regarding cardiac autonomic modulation , the CONCC and ECCC groups exhibited increases in overall variability ( SDNN and SD2 ) at T1 compared to baseline , and the ECCT group demonstrated increases in variables reflecting vagal modulation and the recovery process ( RMSSD , SD1 and HF [ ms2 ] ) at T1 , T2 and T4 compared to baseline .
CONCLUSIONS	Resistance training with emphasis on eccentric contractions promoted strength gain and an increase in cardiac vagal modulation during recovery compared to baseline .

###24732143
OBJECTIVE	The objective of this study is to examine the independent associations of time spent in moderate-to-vigorous physical activity ( MVPA ) and sedentary ( SED-time ) , with total and abdominal body fat ( BF ) , and the bidirectionality of these associations in adults at high risk of type 2 diabetes .
METHODS	We measured MVPA ( min per day ) and SED-time ( h per day ) by accelerometry , and indices of total ( body weight , fat mass ( FM ) , BF % and FM index ) and abdominal BF ( waist circumference ( WC ) ) using standard procedures in 231 adults ( 41.3 6.4 years ) with parental history of type 2 diabetes ( ProActive UK ) at baseline , 1-year and 7-year follow-up .
METHODS	Mixed effects models were used to quantify the independent associations ( expressed as standardised - coefficients ( 95 % confidence interval ( CI ) ) ) of MVPA and SED-time with fat indices , using data from all three time points .
METHODS	All models were adjusted for age , sex , intervention arm , monitor wear time , follow-up time , smoking status , socioeconomic status and MVPA/SED-time .
RESULTS	MVPA was inversely and independently associated with all indices of total BF ( for example , 1 s.d. higher MVPA was associated with a reduction in FM , = -0.09 ( 95 % CI : -0.14 , -0.04 ) s.d. ) and abdominal BF ( for example , WC : = -0.07 ( -0.12 , -0.02 ) ) .
RESULTS	Similarly , higher fat indices were independently associated with a reduction in MVPA ( for example , WC : = -0.25 ( -0.36 , -0.15 ) ; FM : = -0.27 ( -0.36 , -0.18 ) ) .
RESULTS	SED-time was positively and independently associated with most fat indices ( for example , WC : = 0.03 ( -0.04 , 0.09 ) ; FM : = 0.10 ( 0.03 , 0.17 ) ) .
RESULTS	Higher values of all fat indices independently predicted longer SED-time ( for example , WC : = 0.10 ( 0.02 , 0.18 ) , FM : = 0.15 ( 0.07 , 0.22 ) ) .
CONCLUSIONS	The associations of MVPA and SED-time with total and abdominal BF are bidirectional and independent among individuals at high risk for type 2 diabetes .
CONCLUSIONS	The association between BF and MVPA is stronger than the reciprocal association , highlighting the importance of considering BF as a determinant of decreasing activity and a potential consequence .
CONCLUSIONS	Promoting more MVPA and less SED-time may reduce total and abdominal BF .

###25467012
OBJECTIVE	The objective of the study was to investigate the efficacy and safety of hexaminolevulinate ( HAL ) photodynamic therapy ( PDT ) , a novel therapy for women with cervical intraepithelial neoplasia ( CIN ) 1/2 , to define the appropriate population and endpoints for a phase 3 program .
METHODS	This was a double-blind , randomized , placebo-controlled , dose-finding study that included a total of 262 women with biopsy-confirmed CIN 1/2 based on local pathology .
METHODS	Patients received 1 or 2 topical treatments of HAL hydrochloride 0.2 % , 1 % , 5 % , and placebo ointment and were evaluated for response after 3-6 months based on biopsy , Papanicolaou test , and oncogenic human papillomavirus ( HPV ) test .
METHODS	All efficacy analyses were performed on blinded central histology review to avoid interreader variability .
METHODS	Adverse events , blood biochemistry , and vital signs were assessed after 3 months .
RESULTS	There were no statistically significant differences between placebo and either the CIN 1 or combined CIN 1/2 populations .
RESULTS	A cleardose effect with a statistically significant response in theHAL5 % group of 95 % ( 18/19 patients ) compared to 57 % ( 12/21 patients ) in the placebo group ( P < .001 ) was observed at 3months in women with CIN 2 , including an encouraging 83 % ( 5/6 patients ) clearance of HPV 16/18 compared to 33 % ( 2/6 patients ) in the placebo group at 6 months .
RESULTS	The treatment was easy to use and well accepted by patients and gynecologists .
RESULTS	Only local self-limiting adverse reactions including discharge , discomfort , and spotting were reported .
CONCLUSIONS	HAL PDT is a novel therapy that shows promise in the treatment of CIN 2 including clearance of oncogenic HPV , but not of CIN 1 .
CONCLUSIONS	The positive risk/benefit balance makes HAL PDT a tissue-preserving alternative in women of childbearing age who wish to preserve the cervix .
CONCLUSIONS	Confirmatory studies are planned .

###25137864
BACKGROUND	Airway management and endotracheal intubation are essential skills for pediatric residents .
BACKGROUND	Simulation-based technology is used for training residents but it remains unclear whether high fidelity simulation results in better retention of skills compared to low fidelity .
BACKGROUND	The study assesses high fidelity simulation of endotracheal intubation and traditional low fidelity training in improving pediatric residents ' knowledge retention and technical skills ; and if the difference translates into higher `` real time '' intubation success rates .
METHODS	Second and third year pediatric residents were randomized into high fidelity ( intervention ) or low fidelity simulation ( control ) groups .
METHODS	Airway management and intubation skills were taught using a didactic lecture and demonstration on low fidelity mannequins .
METHODS	Knowledge was assessed before randomization ( T0 ) and 6 months after training ( T6 ) .
METHODS	Other outcome measures were : 1 ) airway management and intubation skills at T6 and T12 ( 12 months later ) and 2 ) successful intubation of actual patients by T12 .
RESULTS	10 out of 11 residents completed the intervention .
RESULTS	Theoretical knowledge improved for both groups .
RESULTS	Participants made less mistakes ( M ) overtime : M ( T0 ) = 3.2 and M ( T6 ) = 2.6 for the intervention group , and M ( T0 ) = 4 and M ( T6 ) = 2.40 for the control .
RESULTS	There was no significant effect of fidelity on intubation skills or the number of successful intubations recorded in logbooks ( allp > 0.05 ) .
RESULTS	In some instances intubation skills showed regression over time .
CONCLUSIONS	High fidelity simulation showed no impact on residents ' airway management and intubation skills .
CONCLUSIONS	Retention of theoretical knowledge persisted over time while practical skills remained at baseline or declined .

###25048506
OBJECTIVE	Endoscopic submucosal dissection ( ESD ) is a technically difficult and lengthy procedure requiring optimal depth of sedation .
OBJECTIVE	The bispectral index ( BIS ) monitor is a non-invasive tool that objectively evaluates the depth of sedation .
OBJECTIVE	The purpose of this prospective randomized controlled trial was to evaluate whether BIS guided sedation with propofol and remifentanil could reduce the number of patients requiring rescue propofol , and thus reduce the incidence of sedation - and/or procedure-related complications .
METHODS	A total of 180 patients who underwent the ESD procedure for gastric adenoma or early gastric cancer were randomized to two groups .
METHODS	The control group ( n = 90 ) was monitored by the Modified Observer 's Assessment of Alertness and Sedation scale and the BIS group ( n = 90 ) was monitored using BIS .
METHODS	The total doses of propofol and remifentanil , the need for rescue propofol , and the rates of complications were recorded .
RESULTS	The number of patients who needed rescue propofol during the procedure was significantly higher in the control group than the BIS group ( 47.8 % vs. 30.0 % , p = 0.014 ) .
RESULTS	There were no significant differences in the incidence of sedation - and/or procedure-related complications .
CONCLUSIONS	BIS-guided propofol infusion combined with remifentanil reduced the number of patients requiring rescue propofol in ESD procedures .
CONCLUSIONS	However , this finding did not lead to clinical benefits and thus BIS monitoring is of limited use during anesthesiologist-directed sedation .

###25362680
BACKGROUND	The critical nursing shortage is particularly apparent in specialty areas such as intensive care units ( ICUs ) .
BACKGROUND	Some nurses develop resilient coping strategies and adapt to stressful work experiences , mitigating the development of common maladaptive psychological symptoms .
OBJECTIVE	To determine if a multimodal resilience training program for ICU nurses was feasible to perform and acceptable to the study participants .
METHODS	In a randomized and controlled 12-week intervention study , treatment and control groups completed demographic questions and measures of resilience , anxiety , depression , posttraumatic stress disorder ( PTSD ) , and burnout syndrome before and after the intervention .
METHODS	The intervention included a 2-day educational workshop , written exposure sessions , event-triggered counseling sessions , mindfulness-based stress reduction exercises , and a protocolized aerobic exercise regimen .
METHODS	Nurses in the intervention arm also completed satisfaction surveys for each component of the intervention .
RESULTS	This mulitmodal resilience training program was feasible to conduct and acceptable to ICU nurses .
RESULTS	Both nurses randomized to the treatment group and nurses randomized to the control group showed a significant decrease in PTSD symptom score after the intervention .
CONCLUSIONS	A multifaceted resilience training program for ICU nurses was both feasible and acceptable .
CONCLUSIONS	A sufficiently powered , randomized clinical trial is needed to assess the effect of the intervention on improving individuals ' level of resilience and improving psychological outcomes such as symptoms of anxiety , depression , burnout syndrome , and PTSD .

###24755106
OBJECTIVE	Depression is common among dialysis patients and is associated with adverse outcomes .
OBJECTIVE	Problem-solving therapy ( PST ) is effective for treating depression in older patients with chronic illness , but its effectiveness has never been reported in hemodialysis ( HD ) patients .
OBJECTIVE	We investigated the feasibility and satisfaction of PST and its impact on depression scores among older HD patients .
METHODS	Patients at least 60 years of age receiving maintenance HD at a single outpatient dialysis center were eligible for the study .
METHODS	Randomized patients received either 6 weeks of PST from a licensed renal social worker or usual care .
METHODS	This study modeled the staff-patient ratio standard of most dialysis clinics , and therefore only one social worker provided the interventions .
METHODS	Study outcomes included feasibility ( successful completion of 6 weekly sessions ) and patient satisfaction with PST as well as impact on depression scores ( between-group comparison of mean Beck depression inventory ( BDI ) and Patient health questionnaire-9 ( PHQ-9 ) scores at 6 weeks , and of mean change-from-baseline scores ) .
RESULTS	The recruitment rate was 92 % ( 35/38 ) .
RESULTS	All subjects randomized to the intervention arm ( n = 17 ) and who initiated PST ( n = 15 ) completed the study , and all reported overall satisfaction with the intervention .
RESULTS	87 % reported that PST helped them to better solve problems and improved their ability to cope with their medical condition .
RESULTS	At 6 weeks , there were no significant differences in mean BDI and PHQ scores between the usual care and the intervention group ( BDI 11.3 vs. 9.3 , p = 0.6 ; PHQ 5.7 vs. 3.3 , p = 0.1 ) .
RESULTS	Mean change-from-baseline depression scores were significantly improved in the intervention group relative to the control group ( change in BDI 6.3 vs. - 0.6 , p = 0.004 ; change in PHQ 7.2 vs. 0.3 , p < 0.001 ) .
CONCLUSIONS	The results demonstrate that PST is feasible in the dialysis unit setting , acceptable to patients , and may positively impact depression among maintenance hemodialysis patients .

###25376395
OBJECTIVE	To examine the amount of objectively measured MVPA and LPA that is associated with long-term weight loss and the maintenance of clinically significant weight loss .
METHODS	Adults ( N = 260 ; BMI : 25 to < 40 kg/m ( 2 ) ; age : 18-55 years ) participated in an 18-month behavioral weight loss intervention and were prescribed a low-calorie diet and increased physical activity .
METHODS	Change in weight and objectively measured physical activity were assessed .
METHODS	MVPA > 10 ( MET-min/week ) was computed from bouts > 10 min and > 3.0 METs and MVPA < 10 was computed from bouts < 10 min in duration and > 3.0 METs .
METHODS	LPA was computed from bouts between 1.5 to < 3.0 METs .
RESULTS	When grouped on percent weight loss at 18 months , there was a significant group time interaction effect ( P < 0.0001 ) for both MVPA > 10 and LPA , with both measures being significantly greater at 18 months in those with > 10 % weight loss .
RESULTS	Similar results were observed for MVPA > 10 and LPA with participants grouped on achieving > 10 % weight loss at 6 months and sustaining this at 18 months .
CONCLUSIONS	MVPA > 10 of 200-300 min per week , coupled with increased amounts of LPA , are associated with improved long-term weight loss .
CONCLUSIONS	Interventions should promote engagement in these amounts and types of physical activity .

###24562804
BACKGROUND	Studies with platelet glycoprotein IIb/IIIa receptor inhibitors ( GPIs ) showed conflicting results in primary percutaneous coronary intervention ( PPCI ) patients who were pretreated with 600 mg clopidogrel .
BACKGROUND	We sought to investigate the short - and long-term efficacy and safety of the periprocedural administration of tirofiban in a largest Serbian PPCI centre .
METHODS	We analysed 2995 consecutive PPCI patients enrolled in the Clinical Center of Serbia STEMI Register , between February 2007 and March 2012 .
METHODS	All patients were pretreated with 600 mg clopidogrel and 300 mg aspirin .
METHODS	Major adverse cardiovascular events , comprising all-cause death , nonfatal infarction , nonfatal stroke , and ischaemia-driven target vessel revascularization , was the primary efficacy end point .
METHODS	TIMI major bleeding was the key safety end point .
RESULTS	Analyses drawn from the propensity-matched sample showed improved primary efficacy end point in the tirofiban group at 30-day ( OR 0.72 , 95 % CI 0.53-0 .97 ) and at 1-year ( OR 0.74 , 95 % CI 0.57-0 .96 ) follow up .
RESULTS	Moreover , tirofiban group had a significantly lower 30-day all-cause mortality ( secondary end point ; OR 0.63 , 95 % CI 0.40-0 .90 ) , compared with patients who were not administered tirofiban .
RESULTS	At 1 year , a trend towards a lower all-cause mortality was observed in the tirofiban group ( OR 0.74 , 95 % CI 0.53-1 .04 ) .
RESULTS	No differences were found with respect to the TIMI major bleeding during the follow-up period .
CONCLUSIONS	Tirofiban administered with PPCI , following 600 mg clopidogrel pretreatment , improved primary efficacy outcome at 30 days and at 1 year follow up without an increase in major bleeding .

###25651307
BACKGROUND	Chronic transplant dysfunction ( CTD ) is the leading cause of long-term loss of the renal allograft .
BACKGROUND	So far , no single test is available to reliably predict the risk for CTD .
BACKGROUND	Monitoring of tryptophan ( trp ) metabolism through indoleamine 2.3-dioxygenase ( IDO ) has been previously proposed to predict acute rejection of human kidney transplants .
BACKGROUND	Here , we investigate the potential of IDO/trp degradation along the kynurenine ( kyn ) pathway to predict the long-term outcome of human kidney transplantation .
METHODS	During the 2-year follow-up blood , urine , and kidney biopsies were collected from 48 renal transplant patients .
METHODS	Concentrations of kyn and trp in serum and urine were measured at 2 weeks , 6 months , and 2 years after transplantation .
METHODS	Kynurenine to tryptophan ratio was calculated as an estimate of trp degradation .
METHODS	To evaluate the histological changes and IDO expression , respectively , periodic acid schiff staining and immunohistochemistry for IDO were performed on biopsies taken at 6 months and 2 years .
RESULTS	Two years after transplantation , kyn/trp was increased in urine and decreased in serum as compared to 2-week values .
RESULTS	In 2-year biopsies , IDO expression was mainly found in infiltrating inflammatory cells and in the glomeruli .
RESULTS	The urine level of trp 2 weeks after transplantation predicted the serum creatinine 6 months and the estimated creatinine clearance 2 years after transplantation .
RESULTS	Additionally , serum level of kyn 6 months after transplantation predicted the serum creatinine 2 years after transplantation .
CONCLUSIONS	Early serum and urine levels of trp and kyn may offer a novel route for early detection of patients at risk for developing CTD .

###25927723
BACKGROUND	Regular aspirin use reduces colon adenoma and carcinoma incidence .
BACKGROUND	UDP-glucuronosyltransferases ( UGT ) are involved in aspirin metabolism and clearance , and variant alleles in UGT1A6 have been shown to alter salicylic acid metabolism and risk of colon neoplasia .
METHODS	In a randomized , cross-over , placebo-controlled trial of 44 healthy men and women , homozygous for UGT1A6 * 1 or UGT1A6 * 2 , we explored differences between global epithelial and stromal expression , using Affymetrix U133 +2.0 microarrays and tested effects of 60-day aspirin supplementation ( 325 mg/d ) on epithelial and stromal gene expression and colon prostaglandin E2 ( PGE2 ) levels .
RESULTS	No statistically significant differences in gene expression were observed in response to aspirin or UGT1A6 genotype , but tissue PGE2 levels were lower with aspirin compared to placebo ( p < 0.001 ) .
RESULTS	Transcripts differentially expressed between epithelium and stroma ( N = 4916 , P < 0.01 , false discovery rate < 0.001 ) , included a high proportion of genes involved in cell signaling , cellular movement , and cancer .
RESULTS	Genes preferentially expressed in epithelium were involved in drug and xenobiotic metabolism , fatty acid and lipid metabolism , apoptosis signaling , and ion transport .
RESULTS	Genes preferentially expressed in stroma included those involved in inflammation , cellular adhesion , and extracellular matrix production .
RESULTS	Wnt-Tcf4 pathway genes were expressed in both epithelium and stroma but differed by subcellular location .
CONCLUSIONS	These results suggest that , in healthy individuals , subtle effects of aspirin on gene expression in normal colon tissue are likely overwhelmed by inter-individual variability in microarray analyses .
CONCLUSIONS	Differential expression of critical genes between colonic epithelium and stroma suggest that these tissue types need to be considered separately .

###24715424
OBJECTIVE	To investigate the effect of nutrient stimulation of gut hormones by oligofructose supplementation on appetite , energy intake ( EI ) , body weight ( BW ) and adiposity in overweight and obese volunteers .
METHODS	In a parallel , single-blind and placebo-controlled study , 22 healthy overweight and obese volunteers were randomly allocated to receive 30 g day ( -1 ) oligofructose or cellulose for 6 weeks following a 2-week run-in .
METHODS	Subjective appetite and side effect scores , breath hydrogen , serum short chain fatty acids ( SCFAs ) , plasma gut hormones , glucose and insulin concentrations , EI , BW and adiposity were quantified at baseline and post-supplementation .
RESULTS	Oligofructose increased breath hydrogen ( P < 0.0001 ) , late acetate concentrations ( P = 0.024 ) , tended to increase total area under the curve ( tAUC ) 420 mins peptide YY ( PYY ) ( P = 0.056 ) and reduced tAUC450 mins hunger ( P = 0.034 ) and motivation to eat ( P = 0.013 ) when compared with cellulose .
RESULTS	However , there was no significant difference between the groups in other parameters although within group analyses showed an increase in glucagon-like peptide 1 ( GLP-1 ) ( P = 0.006 ) in the cellulose group and a decrease in EI during ad libitum meal in both groups .
CONCLUSIONS	Oligofructose increased plasma PYY concentrations and suppressed appetite , while cellulose increased GLP-1 concentrations .
CONCLUSIONS	EI decreased in both groups .
CONCLUSIONS	However , these positive effects did not translate into changes in BW or adiposity .

###24526178
BACKGROUND	Triple-negative breast cancer ( TNBC ) patients without pathological complete response ( pCR ) to neoadjuvant chemotherapy have an unfavourable prognosis .
BACKGROUND	TNBC harbouring BRCA-1 germline mutations may be less responsive to taxanes , while sensitivity to DNA-damaging agents is retained .
BACKGROUND	A similar effect was seen in tumours with epigenetic BRCA-1 silencing .
BACKGROUND	Patients without pCR to neoadjuvant chemotherapy consisting of epirubicin plus docetaxel routinely received post-operative CMF at our centre .
BACKGROUND	Here , we investigated the effect of adjuvant CMF in patients with or without BRCA-1 methylation or TP53 mutation .
METHODS	DNA was extracted from formalin-fixed paraffin-embedded tissue .
METHODS	For determining BRCA-1 methylation status , quantitative methylation-specific PCR was performed .
METHODS	For the investigation of TP53 mutation status , DNA was PCR amplified and sequenced by Sanger sequencing .
RESULTS	Twenty-four patients were included ; BRCA-1 methylation was present in 41.7 % , while TP53 mutations were observed in 66.7 % .
RESULTS	At a median follow-up of 27.5 months , 20 % of patients with BRCA-1 methylation had a disease-free survival ( DFS ) event , as compared to 64.3 % in the non-methylated group ( p = 0.0472 ) .
RESULTS	Median DFS in the non-methylated group was 16 months and was not reached in the methylated group ( n.s. ) .
RESULTS	No association TP53 mutation status with clinical outcome was observed .
CONCLUSIONS	Adjuvant CMF is of limited activity in TNBC refractory to taxane-based neoadjuvant chemotherapy .
CONCLUSIONS	In this population , BRCA-1 methylation was associated with a significant decrease in DFS events suggesting a better prognosis and potentially retained activity of DNA-damaging agents .

###24479388
BACKGROUND	New evidence indicates that increased dietary protein ingestion promotes health and recovery from illness , and also maintains functionality in older adults .
BACKGROUND	The present study aimed to investigate whether a novel food service concept with protein-supplementation would increase protein and energy intake in hospitalised patients at nutritional risk .
METHODS	A single-blinded randomised controlled trial was conducted .
METHODS	Eighty-four participants at nutritional risk , recruited from the departments of Oncology , Orthopaedics and Urology , were included .
METHODS	The intervention group ( IG ) received the protein-supplemented food service concept .
METHODS	The control group ( CG ) received the standard hospital menu .
METHODS	Primary outcome comprised the number of patients achieving 75 % of energy and protein requirements .
METHODS	Secondary outcomes comprised mean energy and protein intake , body weight , handgrip strength and length of hospital stay .
RESULTS	In IG , 76 % versus 70 % CG patients reached 75 % of their energy requirements ( P = 0.57 ) ; 66 % IG versus 30 % CG patients reached 75 % of their protein requirements ( P = 0.001 ) .
RESULTS	The risk ratio for achieving 75 % of protein requirements : 2.2 ( 95 % confidence interval = 1.3-3 .7 ) ; number needed to treat = 3 ( 95 % confidence interval = 2-6 ) .
RESULTS	IG had a higher mean intake of energy and protein when adjusted for body weight ( CG : 82kJkg ( -1 ) versus IG : 103kJkg ( -1 ) , P = 0.013 ; CG : 0.7 g proteinkg ( -1 ) versus 0.9 g proteinkg ( -1 ) , P = 0.003 ) .
RESULTS	Body weight , handgrip strength and length of hospital stay did not differ between groups .
CONCLUSIONS	The novel food service concept had a significant positive impact on overall protein intake and on weight-adjusted energy intake in hospitalised patients at nutritional risk .

###24673043
OBJECTIVE	To compare the efficacy of different points combination in the treatment of menopausal insomnia .
METHODS	Ninety-six cases of menopausal insomnia were randomized into 3 groups , Xinshu ( BL 15 ) , Shenshu ( BL 23 ) , Sishencong ( EX-HN 1 ) , Shenmen ( HT 7 ) , Sanyinjiao ( SP 6 ) were chosen in the restore interaction between the heart and the kidney group ( group A , 32 cases ) ; Zhaohai ( KI 6 ) , Jiaoxin ( KI 8 ) , Shenmai ( BL 62 ) , Pucan ( BL 61 ) were chosen in the acupuncturing qiao mai group ( group B , 32 cases ) ; auricular Shenmen ( TF4 ) and sensitive spot at the distribution area of auricular vagus nervus were chosen in the ear acupuncture group ( group C , 32 cases ) .
METHODS	Six days made one session and the treatments were finished after 4 courses .
METHODS	The polysomnography ( PSG ) and Pittsburgh sleep quality index ( PSQI ) were employed before and after treatment to evaluate the alleviation of insomnia .
RESULTS	The parameters of the sleep latency ( SL ) , rapid wave sleep latency ( RL ) and sleep efficiency ( SE ) were significantly improved in the three groups , and the differences were statistically significant ( P < 0.05 , P < 0.01 ) .
RESULTS	The SL and awaking time ( AT ) in group C [ SL ( 401.08 + / - 16.54 ) min and AT ( 4.87 + / - 2.64 ) times ] were significantly superior to those in the other two groups [ SL ( 50.36 + / - 18.47 ) min , ( 54.87 + / - 20.92 ) min , AT ( 5.98 + / - 2.11 ) times , ( 6.13 + / - 3.04 ) times , all P < 0.05 ] .
RESULTS	The S ( 3 +4 ) ( % ) in group C was also significantly higher than those in the other two groups ( both P < 0.05 ) .
RESULTS	It was indicated by PSQI that the sleep quality of group C ( 0.78 + / - 0.12 ) was significantly superior to that in group B ( 1.32 + / - 0.29 ) , the total score and cured and markedly effective rate in group C [ ( 4.34 + / - 1.43 ) , 68.8 % ( 22/32 ) ] were superior to those in group A [ ( 7.48 + / - 3.09 ) , 53.1 % ( 17/32 ) , both P < 0.05 ] .
CONCLUSIONS	Ear acupuncture has a better curative effect than the restore interaction between the heart and the kidney group and acupuncturing qiao mai group , it is worth of being promoted .

###24577971
BACKGROUND	Latinas with breast cancer suffer symptom and psychosocial health disparities .
BACKGROUND	Effective interventions have not been developed for or tested in this population .
OBJECTIVE	We describe community-based participatory research methods used to develop and implement the Nuevo Amanecer program , a culturally tailored , peer-delivered cognitive-behavioral stress management intervention for low-income Spanish-speaking Latinas with breast cancer , and unique considerations in implementing a randomized controlled trial to test the program in community settings .
METHODS	We applied an implementation science framework to delineate the methodological phases used to develop and implement the Nuevo Amanecer program and trial , emphasizing community engagement processes .
RESULTS	In phase 1 , we established project infrastructure : academic and community co-principal investigators , community partners , community advisory board , steering committee , and funding .
RESULTS	In phase 2 , we identified three program inputs : formative research , a community best-practices model , and an evidence-based intervention tested in non-Latinas .
RESULTS	In phase 3 , we created the new program by integrating and adapting intervention components from the three sources , making adaptations to accommodate low literacy , Spanish language , cultural factors , community context , and population needs .
RESULTS	In phase 4 , we built community capacity for the program and trial by training field staff ( recruiters and interventionists embedded in community sites ) , compensating field staff , and creating a system for identifying potential participants .
RESULTS	In phase 5 , we implemented and monitored the program and trial .
RESULTS	Engaging community partners in all phases has resulted in a new , culturally tailored program that is suitable for newly diagnosed Latinas with breast cancer and a trial that is acceptable and supported by community and clinical partners .
RESULTS	Lessons learned Engagement of community-based organizations and cancer survivors as research partners and hiring recruiters and interventionists from the community were critical to successful implementation in community settings .
RESULTS	Having culturally and linguistically competent research staff with excellent interpersonal skills facilitated implementation .
RESULTS	Facilitating and maintaining excellent communication among community partners was imperative to troubleshoot implementation issues .
RESULTS	Randomization was challenging due to community concerns about assigning women to a control group .
RESULTS	Patient privacy regulations and the need for extensive outreach to establish relationships between community partners and clinical sites hampered initial recruitment .
CONCLUSIONS	These were resource-intensive processes to develop and implement the program that need to be compared to less-intensive alternatives .
CONCLUSIONS	Engaging community members in design and implementation of community-based programs and trials enhances cultural appropriateness and congruence with the community context .
CONCLUSIONS	If the randomized trial demonstrates that the intervention is effective , it will fill a gap in evidence-based programs to address ethnic disparities in quality of life among Spanish-speaking Latinas with breast cancer .

###25452426
OBJECTIVE	Exercise intolerance is a hallmark of chronic obstructive pulmonary disease ( COPD ) .
METHODS	Patients with COPD were randomized in two multicentre , double-blind , incomplete block crossover studies .
METHODS	Patients received two of six treatments in sequence ( 12 weeks each ) : placebo , umeclidinium ( UMEC ) / vilanterol ( VI ) ( 125/25 mcg or 62.5 / 25 mcg ) , VI ( 25 mcg ) or UMEC ( 62.5 mcg or 125 mcg ) .
METHODS	Exercise endurance time ( EET ) and trough forced expiratory volume in 1 second ( FEV1 ) ( Week 12 ) were co-primary endpoints .
METHODS	Safety was monitored throughout .
RESULTS	Both studies showed similar 3-hour post-dose EET improvements from baseline for UMEC/VI ( Week 12 ) .
RESULTS	Significant EET improvements were observed with both UMEC/VI doses versus placebo at Week 12 in Study 418 ( UMEC/VI 125/25 mcg : 65.8 s ; p = 0.005 ; UMEC/VI 62.5 / 25 mcg : 69.4 s ; p = 0.003 ) , but not in Study 417 , where a placebo effect was evident .
RESULTS	Post hoc integrated data analysis showed significant but smaller EET improvements for both UMEC/VI doses versus placebo at Week 12 ( UMEC/VI 125/25mcg : 47.5 s ; p = 0.002 ; UMEC/VI 62.5 / 25 mcg : 43.7 s ; p = 0.001 ) .
RESULTS	Both studies showed trough FEV1 improvements at Week 12 for both UMEC/VI doses .
RESULTS	The incidence of adverse events was similar between treatment groups within each study .
CONCLUSIONS	UMEC/VI improved lung function and EET .

###24884466
BACKGROUND	Fear of falling ( FOF ) is commonly experienced in people with Parkinson 's disease ( PD ) .
BACKGROUND	It is a predictor of recurrent falls , a barrier to physical exercise , and negatively associated with health-related quality of life .
BACKGROUND	A variety of rating scales exist that assess different aspects of FOF but comprehensive head-to-head comparisons of their psychometric properties in people with PD are lacking .
BACKGROUND	The aim of this study was to evaluate the psychometric properties of four FOF rating scales in people with PD .
BACKGROUND	More specifically , we investigated and compared the scales ' data completeness , scaling assumptions , targeting , and reliability .
METHODS	The FOF rating scales were : the Falls Efficacy Scale-International ( FES-I ) , the Swedish FES ( FES ( S ) ) , the Activities-specific Balance Confidence scale ( ABC ) , and the modified Survey of Activities and Fear of Falling in the Elderly ( mSAFFE ) .
METHODS	A postal survey was administered to 174 persons with PD .
METHODS	Responders received a second survey after two weeks .
RESULTS	The mean ( SD ) age and PD duration of the 102 responders were 73 ( 8 ) and 7 ( 6 ) years , respectively .
RESULTS	ABC had worse data completeness than the other scales ( 6.9 vs. 0.9-1 .3 % missing data ) .
RESULTS	All scales had corrected item-total correlations exceeding 0.4 and showed acceptable reliabilities ( Cronbach 's alpha and Intraclass Correlation Coefficient ( ICC ) > 0.80 ) but only FES-I had ICC > 0.90 .
RESULTS	The standard error of measurements ranged from 7 % ( FES-I ) to 12 % ( FES ( S ) ) , and the smallest detectable differences ranged from 20 % ( FES-I ) to 33 % ( FES ( S ) ) of the total score ranges .
RESULTS	ABC and FES ( S ) had substantially more outliers than mSAFFE and FES-I ( 10 and 15 vs. 3 and 4 , respectively ) when the two test occasions were compared .
CONCLUSIONS	When assessing FOF in people with PD , the findings in the present study favoured the choice of FES-I or mSAFFE .
CONCLUSIONS	However , FES-I was the only scale with ICC > 0.90 which has been suggested as a minimum when using a scale for individual comparisons .

###24343979
BACKGROUND	Agreement between client and therapist on treatment goals has been consistently linked with improved treatment outcomes .
BACKGROUND	Having clear and collaborative goals may be particularly important when working with clients diagnosed with personality disorders who are often difficult to engage and test the boundaries of therapy .
BACKGROUND	This paper outlines the development of a personality disorder treatment goal checklist aimed at helping clients and therapists to identify and prioritize their goals for therapy .
METHODS	The checklist was developed using self-reported problems of the first 90 participants randomized into the psychoeducation and problem solving ( PEPS ) trial .
METHODS	Problems were coded and categorized into problem areas .
METHODS	The checklist was viewed by two service users who gave suggestions for improvements .
RESULTS	The final checklist consists of 161 items in 16 problem areas .
CONCLUSIONS	The checklist may provide a clinically useful tool for working with this client group .

###24997005
BACKGROUND	LCn-3PUFA comprised of eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) offer cardioprotection involving a decrease in coagulant activity ; however , the evidence is equivocal .
BACKGROUND	We have previously demonstrated that the acute ( 24 h ) effects and chronic ( 4 weeks ) effects of LCn-3PUFA supplementation on platelet aggregation in human subjects are sex specific .
BACKGROUND	This study investigated the mechanisms of the sex-dependent effects of LCn-3PUFA with 4 weeks supplementation of EPA-rich vs. DHA-rich oils on procoagulant and platelet activity in healthy subjects .
METHODS	A double-blinded , placebo-controlled randomised trial was conducted in 94 healthy adults : male ( n = 41 ) and female ( n = 53 ) .
METHODS	Platelet coagulation parameters including factors I , II , V , VII , VIII , IX , X , vWF : Ag and endogenous thrombin potential were measured at baseline and 4 weeks postsupplementation with EPA-rich or DHA-rich oil capsules .
RESULTS	We have previously reported that platelet aggregation is specifically reduced by supplementation with EPA in males and DHA in females .
RESULTS	This sex-specific effect was also observed for decreases in plasma levels of Factor II ( -7.9 3.8 % , P = .026 ) , Factor V ( -6.5 4.5 % , P = .022 ) and vWF : Ag ( -7.3 2.1 % , P = .034 ) and was most pronounced in males supplemented with EPA .
RESULTS	In contrast , DHA-mediated reduction in platelet aggregation in females was not accompanied by any significant changes in the coagulation parameters tested .
CONCLUSIONS	Significant interactions between sex and specific LCn-3PUFA exist to reduce procoagulant activity differentially in males vs. females and could have profound effects on managing risk of thrombotic disease .

###25878304
BACKGROUND	Over the past decades , the operative treatment of displaced midshaft clavicular fractures has increased .
BACKGROUND	The aim of this study was to compare short and midterm results of open reduction and plate fixation with those of intramedullary nailing for displaced midshaft clavicular fractures .
METHODS	A multicenter , randomized controlled trial was performed in four different hospitals .
METHODS	The study included 120 patients , eighteen to sixty-five years of age , treated with either open reduction and plate fixation ( n = 58 ) or intramedullary nailing ( n = 62 ) .
METHODS	Preoperative and postoperative shoulder function scores and complications were documented until one year postoperatively .
METHODS	Significance was set at p < 0.05 .
RESULTS	No significant differences in the Disabilities of the Arm , Shoulder and Hand ( DASH ) or Constant-Murley score ( 3.0 and 96.0 points for the plate group and 5.6 and 95.5 points for the nailing group ) were noted between the two surgical interventions at six months postoperatively .
RESULTS	Until six months after the surgery , the plate-fixation group experienced less disability than the nailing group as indicated by the area under the curve of the DASH scores for this time period ( p = 0.02 ) .
RESULTS	The mean numbers of complications per patient , irrespective of their severity , were similar between the plate-fixation ( 0.67 ) and nailing ( 0.74 ) groups ( p = 0.65 ) .
CONCLUSIONS	The patients in the plate-fixation group recovered faster than the patients in the intramedullary nailing group , but the groups had similar results at six months postoperatively and the time of final follow-up .
CONCLUSIONS	The rate of complications requiring revision surgery was low .
CONCLUSIONS	Implant-related complications occurred frequently and could often be treated by implant removal .

###24548978
OBJECTIVE	To evaluate the effect of formulation and a high-fat meal on the pharmacokinetics of orally administered lenvatinib ( E7080 ) .
METHODS	Lenvatinib 10-mg capsule and tablet .
METHODS	Pharmacokinetics and safety of a single 10-mg lenvatinib dose were evaluated in healthy subjects in two randomized , two-period , crossover , phase 1 , bioavailability trials .
METHODS	The first compared a new capsule formulation with an older tablet formulation ( n = 20 subjects ) ; the second evaluated the influence of a standard high-fat meal on the relative bioavailability of the capsule formulation ( n = 16 subjects ) .
METHODS	Geometric least squares mean ratios of AUC0 - , maximum observed concentration ( Cmax ) , and AUC0-t were determined .
METHODS	tmax , tlag ( food effect only ) , and t1/2 , z were also calculated , and descriptive statistics were provided .
RESULTS	A total of 36 healthy volunteers were enrolled in the two studies ( mean ages 29 and 33 years ) .
RESULTS	In the formulation study , AUC0 - and AUC0-t of the capsule formulation were ~ 10 % less than the tablet formulation , and Cmax for the capsule formulation was ~ 14 % lower .
RESULTS	90 % Confidence intervals ( CIs ) for both AUCs were within the 80 - 125 % CI , which is generally considered to denote bioequivalence , while the lower bound of the interval for Cmax was 79.8 % .
RESULTS	tmax and t1/2 , z were comparable .
RESULTS	For the capsule formulation , the mean ( % CV ) t1/2 , z was 27.6 hours ( 27.3 ) and the median ( range ) tmax was 2.0 hours ( 2 - 4 ) .
RESULTS	In the food effect study , lenvatinib 's AUC0 - and AUC0-t increased ~ 6 % and 4 % with the high-fat meal .
RESULTS	Cmax following a high-fat meal was 5 % lower than following administration in the fasted state .
RESULTS	Administration with food delayed lenvatinib 's tmax ( 2 vs. 4 hours ) .
RESULTS	90 % CIs for AUCs were within the 80 - 125 % CI , while the CI for Cmax was 72.1 - 126.4 % .
RESULTS	The single 10-mg dose demonstrated an acceptable tolerability profile ; treatment-emergent adverse events occurred in 9 subjects ( 25 % ) overall and were typically mild in severity .
CONCLUSIONS	These studies show that a new capsule formulation produces slightly lower exposure ( ~ 10 - 14 % ) to lenvatinib compared with the original tablet formulation , and that oral administration with a high-fat meal does not significantly affect exposure , although absorption is delayed .
CONCLUSIONS	Thus , lenvatinib can be administered without regard to the timing of meals .

###24856992
OBJECTIVE	To study the clinical effectiveness and safety of nasal intermittent positive pressure ventilation ( NIPPV ) in the initial treatment of neonatal respiratory distress syndrome ( NRDS ) and the initial setting of NIPPV parameters .
METHODS	One hundred neonates with NRDS were divided into NIPPV group ( n = 50 ) and nasal continuous positive airway pressure ( NCPAP ) group ( n = 50 ) .
METHODS	A randomized controlled study was conducted to compare the effectiveness of NIPPV versus NCPAP in the initial treatment of NRDS from the following aspects : reducing CO2 retention , improving oxygenation , reducing second endotracheal intubation and second use of pulmonary surfactant ( PS ) , reducing the duration of invasive respiratory support , reducing the duration of oxygen use , and reducing the incidence of air leak , abdominal distension and ventilator-associated pneumonia .
RESULTS	After 1 and 6 hours of noninvasive respiratory support , the NIPPV group was superior to the NCPAP group with respect to the reduction in CO2 retention and improvement in oxygenation ( P < 0.05 ) ; in addition , compared with the NCPAP group , the NIPPV group had significantly lower rates of second endotracheal intubation and second PS use , significantly shorter duration of invasive respiratory support and time of FiO2 > 0.21 , and significantly lower incidence of apnea and ventilator-associated pneumonia ( P < 0.05 ) ; there were no significant differences in the incidence of air leak and abdominal distention between the two groups .
CONCLUSIONS	NIPPV is effective and safe in the initial treatment of NRDS and holds promise for clinical application .

###25467562
BACKGROUND	Patients are increasingly being admitted with chronic atrial fibrillation , and disease-specific management might reduce recurrent admissions and prolong survival .
BACKGROUND	However , evidence is scant to support the application of this therapeutic approach .
BACKGROUND	We aimed to assess SAFETY -- a management strategy that is specific to atrial fibrillation .
METHODS	We did a pragmatic , multicentre , randomised controlled trial in patients admitted with chronic , non-valvular atrial fibrillation ( but not heart failure ) .
METHODS	Patients were recruited from three tertiary referral hospitals in Australia .
METHODS	335 participants were randomly assigned by computer-generated schedule ( stratified for rhythm or rate control ) to either standard management ( n = 167 ) or the SAFETY intervention ( n = 168 ) .
METHODS	Standard management consisted of routine primary care and hospital outpatient follow-up .
METHODS	The SAFETY intervention comprised a home visit and Holter monitoring 7-14 days after discharge by a cardiac nurse with prolonged follow-up and multidisciplinary support as needed .
METHODS	Clinical reviews were undertaken at 12 and 24 months ( minimum follow-up ) .
METHODS	Coprimary outcomes were death or unplanned readmission ( both all-cause ) , measured as event-free survival and the proportion of actual versus maximum days alive and out of hospital .
METHODS	Analyses were done on an intention-to-treat basis .
METHODS	The trial is registered with the Australian New Zealand Clinical Trials Registry ( ANZCTRN 12610000221055 ) .
RESULTS	During median follow-up of 905 days ( IQR 773-1050 ) , 49 people died and 987 unplanned admissions were recorded ( totalling 5530 days in hospital ) .
RESULTS	127 ( 76 % ) patients assigned to the SAFETY intervention died or had an unplanned readmission ( median event-free survival 183 days [ IQR 116-409 ] ) and 137 ( 82 % ) people allocated standard management achieved a coprimary outcome ( 199 days [ 116-249 ] ; hazard ratio 097 , 95 % CI 076-123 ; p = 0851 ) .
RESULTS	Patients assigned to the SAFETY intervention had 995 % maximum event-free days ( 95 % CI 993-997 ) , equating to a median of 900 ( IQR 767-1025 ) of 937 maximum days alive and out of hospital .
RESULTS	By comparison , those allocated to standard management had 992 % ( 95 % CI 988-994 ) maximum event-free days , equating to a median of 860 ( IQR 752-1047 ) of 937 maximum days alive and out of hospital ( effect size 022 , 95 % CI 021-023 ; p = 0039 ) .
CONCLUSIONS	A post-discharge management programme specific to atrial fibrillation was associated with proportionately more days alive and out of hospital ( but not prolonged event-free survival ) relative to standard management .
CONCLUSIONS	Disease-specific management is a possible strategy to improve poor health outcomes in patients admitted with chronic atrial fibrillation .
BACKGROUND	National Health and Medical Research Council of Australia .

###24617764
OBJECTIVE	To examine the effects of using vinyl isolation bags or polyethylene wrap for the prevention of postnatal hypothermia in preterm infants at 32 weeks gestation .
METHODS	A prospective , randomized controlled trial .
METHODS	The neonatal intensive care unit ( NICU ) of the Istanbul Faculty of Medicine in Turkey .
METHODS	Fifty-nine preterm infants .
METHODS	Participants were randomly assigned to either the vinyl isolation-bag experimental group ( n = 22 ) or the polyethylene-wrap control group ( n = 37 ) .
METHODS	Infant body temperature was measured at four time points after birth .
RESULTS	Loss of body temperature was significantly less in the vinyl isolation-bag group during the first 60 minutes after birth ( p = .041 ) .
RESULTS	Body temperature decreased by 1.41 1.65 C in the vinyl isolation-bag group and 2.75 1.68 C in the polyethylene wrap group .
RESULTS	Body temperature was significantly less in the polyethylene wrap group compared to the vinyl isolation-bag group at birth to 60 minutes ( p = .004 ) .
CONCLUSIONS	Wrapping preterm infants of gestational age 32 weeks in vinyl bags immediately after birth is associated with lower incidences of hypothermia .

###25381393
BACKGROUND	Previous studies have suggested the potential importance of three DPYD variants ( DPYD * 2A , D949V , and I560S ) with increased 5-FU toxicity .
BACKGROUND	Their individual associations , however , in 5-FU-based combination therapies , remain controversial and require further systematic study in a large patient population receiving comparable treatment regimens with uniform clinical data .
METHODS	We genotyped 2886 stage III colon cancer patients treated adjuvantly in a randomized phase III trial with FOLFOX or FOLFIRI , alone or combined with cetuximab , and tested the individual associations between functionally deleterious DPYD variants and toxicity .
METHODS	Logistic regressions were used to assess univariate and multivariable associations .
METHODS	All statistical tests were two-sided .
RESULTS	In 2594 patients with complete adverse event ( AE ) data , the incidence of grade 3 or greater 5FU-AEs in DPYD * 2A , I560S , and D949V carriers were 22/25 ( 88.0 % ) , 2/4 ( 50.0 % ) , and 22/27 ( 81.5 % ) , respectively .
RESULTS	Statistically significant associations were identified between grade 3 or greater 5FU-AEs and both DPYD * 2A ( odds ratio [ OR ] = 15.21 , 95 % confidence interval [ CI ] = 4.54 to 50.96 , P < .001 ) and D949V ( OR = 9.10 , 95 % CI = 3.43 to 24.10 , P < .001 ) variants .
RESULTS	Statistical significance remained after adjusting for multiple variables .
RESULTS	The DPYD * 2A variant statistically significantly associated with the specific AEs nausea/vomiting ( P = .007 ) and neutropenia ( P < .001 ) , whereas D949V statistically significantly associated with dehydration ( P = .02 ) , diarrhea ( P = .003 ) , leukopenia ( P = .002 ) , neutropenia ( P < .001 ) , and thrombocytopenia ( P < .001 ) .
RESULTS	Although two patients with I560S had grade3 5FU-AEs ; a statistically significant association could not be demonstrated because of its low frequency ( P = .48 ) .
CONCLUSIONS	In the largest study to date , statistically significant associations were found between DPYD variants ( DPYD * 2A and D949V ) and increased incidence of grade 3 or greater 5FU-AEs in patients treated with adjuvant 5-FU-based combination chemotherapy .

###24636948
OBJECTIVE	To compare structural knee joint changes in obese patients with knee osteoarthritis ( OA ) that after an intensive weight loss therapy were randomized to continuous dietetic support , a specialized knee exercise program , or ` no attention ' for 1 year .
METHODS	192 obese individuals with knee OA underwent an intensive 16-week weight loss program with subsequent randomization to one of the three treatment groups .
METHODS	Changes in cartilage loss , bone marrow lesions ( BMLs ) , synovitis , and effusion were assessed using semi quantitative assessments of magnetic resonance imaging ( MRI ) obtained at weeks 0 and 68 applying the BLOKS score .
RESULTS	During the 52 weeks maintenance period the continuous dietary maintenance group support on average gained 1.1 kg ( 95 % CI : -0.3:2.5 ) body mass , the exercise group gained 6.6 kg ( 95 % CI 5.4:7.8 ) and the no-attention group gained 4.8 kg ( 95 % CI : 2.9:6.7 ) .
RESULTS	There were no statistically significant between-group differences in changes in cartilage loss , synovitis or effusion at the follow-up ( analysis of covariance ; ANCOVA , P > 0.16 ) , while there was an increased number of medial tibiofemoral BMLs in the exercise group ( ANCOVA , P = 0.015 ) compared to both diet ( difference : -0.21 [ 95 % CI -0.40 : -0.03 ] ) and `` no attention '' ( difference : -0.26 [ 95 % CI -0.44 : -0.07 ] ) groups .
CONCLUSIONS	In this 1 year follow-up after weight-loss in obese knee OA patients , we found a potentially increased number of BMLs in the exercise group compared to the diet and no attention groups , with no between-group differences in changes in cartilage loss , synovitis or effusion .
CONCLUSIONS	These findings should be interpreted with caution for exercise compliance , MRI methodology and follow-up time .
CONCLUSIONS	( ClinicalTrials.gov identifier : NCT00655941 ) .

###24947106
BACKGROUND	Stimulation and nutrition delivered through health programmes at a large scale could potentially benefit more than 200 million young children worldwide who are not meeting their developmental potential .
BACKGROUND	We investigated the feasibility and effectiveness of the integration of interventions to enhance child development and growth outcomes in the Lady Health Worker ( LHW ) programme in Sindh , Pakistan .
METHODS	We implemented a community-based cluster-randomised effectiveness trial through the LHW programme in rural Sindh , Pakistan , with a 22 factorial design .
METHODS	We randomly allocated 80 clusters ( LHW catchments ) of children to receive routine health and nutrition services ( controls ; n = 368 ) , nutrition education and multiple micronutrient powders ( enhanced nutrition ; n = 364 ) , responsive stimulation ( responsive stimulation ; n = 383 ) , or a combination of both enriched interventions ( n = 374 ) .
METHODS	The allocation ratio was 1:20 ( ie , 20 clusters per intervention group ) .
METHODS	The data collection team were masked to the allocated intervention .
METHODS	All children born in the study area between April , 2009 , and March , 2010 , were eligible for enrolment if they were up to 25 months old without signs of severe impairments .
METHODS	Interventions were delivered by LHWs to families with children up to 24 months of age in routine monthly group sessions and home visits .
METHODS	The primary endpoints were child development at 12 and 24 months of age ( assessed with the Bayley Scales of Infant and Toddler Development , Third Edition ) and growth at 24 months of age .
METHODS	Analysis was by intention to treat .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT007159636 .
RESULTS	1489 mother-infant dyads were enrolled into the study , of whom 1411 ( 93 % ) were followed up until the children were 24 months old .
RESULTS	Children who received responsive stimulation had significantly higher development scores on the cognitive , language , and motor scales at 12 and 24 months of age , and on the social-emotional scale at 12 months of age , than did those who did not receive the intervention .
RESULTS	Children who received enhanced nutrition had significantly higher development scores on the cognitive , language , and social-emotional scales at 12 months of age than those who did not receive this intervention , but at 24 months of age only the language scores remained significantly higher .
RESULTS	We did not record any additive benefits when responsive stimulation was combined with nutrition interventions .
RESULTS	Responsive stimulation effect sizes ( Cohen 's d ) were 06 for cognition , 07 for language , and 05 for motor development at 24 months of age ; these effect sizes were slightly smaller for the combined intervention group and were low to moderate for the enhanced nutrition intervention alone .
RESULTS	Children exposed to enhanced nutrition had significantly better height-for-age Z scores at 6 months ( p < 00001 ) and 18 months ( p = 002 ) than did children not exposed to enhanced nutrition .
RESULTS	Longitudinal analysis showed a small benefit to linear growth from enrolment to 24 months ( p = 0026 ) in the children who received the enhanced nutrition intervention .
CONCLUSIONS	The responsive stimulation intervention can be delivered effectively by LHWs and positively affects development outcomes .
CONCLUSIONS	The absence of a major effect of the enhanced nutrition intervention on growth shows the need for further analysis of mediating variables ( eg , household food security status ) that will help to optimise future nutrition implementation design .
BACKGROUND	UNICEF .

###25498732
BACKGROUND	Multiple system atrophy is a complex neurodegenerative disorder for which no effective treatment exists .
BACKGROUND	We aimed to assess the effect of rasagiline on symptoms and progression of the parkinsonian variant of multiple system atrophy .
METHODS	We did this randomised , double-blind , placebo-controlled trial between Dec 15 , 2009 , and Oct 20 , 2011 , at 40 academic sites specialised in the care of patients with multiple systemic atrophy across 12 countries .
METHODS	Eligible participants aged 30 years or older with possible or probable parkinsonian variant multiple system atrophy were randomly assigned ( 1:1 ) , via computer-generated block randomisation ( block size of four ) , to receive either rasagiline 1 mg per day or placebo .
METHODS	Randomisation was stratified by study centre .
METHODS	The investigators , study funder , and personnel involved in patient assessment , monitoring , analysis and data management were masked to group assignment .
METHODS	The primary endpoint was change from baseline to study end in total Unified Multiple System Atrophy Rating Scale ( UMSARS ) score ( parts I and II ) .
METHODS	Analysis was by modified intention to treat .
METHODS	The trial is registered with ClinicalTrials.gov , number NCT00977665 .
RESULTS	We randomly assigned 174 participants to the rasagiline group ( n = 84 ) or the placebo group ( n = 90 ) ; 21 ( 25 % ) patients in the rasagiline group and 15 ( 17 % ) in the placebo group withdrew from the study early .
RESULTS	At week 48 , patients in the rasagiline group had progressed by an adjusted mean of 72 ( SE 12 ) total UMSARS units versus 78 ( 11 ) units in those in the placebo group .
RESULTS	This treatment difference of -060 ( 95 % CI -368 to 247 ; p = 070 ) was not significant .
RESULTS	68 ( 81 % ) patients in the rasagiline group and 67 ( 74 % ) patients in the placebo group reported adverse events , and we recorded serious adverse events in 29 ( 35 % ) versus 23 ( 26 % ) patients .
RESULTS	The most common adverse events in the rasagiline group were dizziness ( n = 10 [ 12 % ] ) , peripheral oedema ( n = 9 [ 11 % ] ) , urinary tract infections ( n = 9 [ 11 % ] ) , and orthostatic hypotension ( n = 8 [ 10 % ] ) .
CONCLUSIONS	In this population of patients with the parkinsonian variant of multiple system atrophy , treatment with rasagiline 1 mg per day did not show a significant benefit as assessed by UMSARS .
CONCLUSIONS	The study confirms the sensitivity of clinical outcomes for multiple system atrophy to detect clinically significant decline , even in individuals with early disease .
BACKGROUND	Teva Pharmaceutical Industries and H Lundbeck A/S .

###24570011
BACKGROUND	Ultravision is a new device that utilizes electrostatic precipitation to clear surgical smoke .
BACKGROUND	The aim was to evaluate its performance during laparoscopic cholecystectomy .
METHODS	Patients undergoing laparoscopic cholecystectomy were randomized into `` active ( device on ) '' or `` control ( device off ) . ''
METHODS	Three operating surgeons scored the percentage effective visibility and three reviewers scored the percentage of the procedure where smoke was present .
METHODS	All assessors also used a 5-point scale ( 1 = imperceptible/excellent and 5 = very annoying/bad ) to rate visual impairment .
METHODS	Secondary outcomes were the number of smoke-related pauses , camera cleaning , and pneumoperitoneum reductions .
METHODS	Mean results are presented with 95 % confidence intervals ( CI ) .
RESULTS	In 30 patients ( active 13 , control 17 ) , the effective visibility was 89.2 % ( 83.3-95 .0 ) for active cases and 71.2 % ( 65.7-76 .7 ) for controls .
RESULTS	The proportion of the procedure where smoke was present was 41.1 % ( 33.8-48 .3 ) for active cases and 61.5 % ( 49.0-74 .1 ) for controls .
RESULTS	Operating surgeons rated the visual impairment as 2.2 ( 1.7-2 .6 ) for active cases and 3.2 ( 2.8-3 .5 ) for controls .
RESULTS	Reviewers rated the visual impairment as 2.3 ( 2.0-2 .5 ) for active cases and 3.2 ( 2.8-3 .7 ) for controls .
RESULTS	In the active group , 23 % of procedures were paused to allow smoke clearance compared to 94 % of control cases .
RESULTS	Camera cleaning was not needed in 85 % of active procedures and 35 % of controls .
RESULTS	The pneumoperitoneum was reduced in 0 % of active cases and 88 % of controls .
CONCLUSIONS	Ultravision improves visibility during laparoscopic surgery and reduces delays in surgery for smoke clearance and camera cleaning .

###25097088
OBJECTIVE	Propofol injection pain , despite various strategies , remains common and troublesome .
OBJECTIVE	This study aimed to test the hypothesis that pretreatment with the combination of intravenous lidocaine and magnesium would have an additive effect on reducing propofol injection pain .
METHODS	After institutional review board ( IRB ) approval and informed consent , we performed a prospective , double-blind , placebo-controlled , randomized trial .
METHODS	Subjects were randomly assigned to pretreatment with either lidocaine ( 50mg ) , magnesium sulfate ( 0.25 mg ) , lidocaine ( 50mg ) plus magnesium sulfate ( 0.25 mg ) , or 0.9 % sodium chloride .
METHODS	Following pretreatment , propofol ( 50mg ) was administered , and subjects were questioned regarding injection site pain and observed for behavioral signs of pain .
RESULTS	Two hundred subjects were enrolled and 158 subjects ( 39 placebo , 38 lidocaine , 44 magnesium sulfate , and 37 lidocaine plus magnesium sulfate ) received their assigned pretreatment intervention .
RESULTS	Intergroup baseline characteristics were similar .
RESULTS	The proportion of subjects reporting propofol injection pain was highest in those pretreated with magnesium sulfate ( 57 % ) , followed by those pretreated with placebo ( 46 % ) , lidocaine plus magnesium sulfate ( 41 % ) , and then lidocaine ( 29 % ; p = 0.011 ) .
RESULTS	When adjusted for age , gender , diabetes mellitus , chronic pain , tobacco use , and selective-serotonin reuptake inhibitor use , the pain response scale scores were significantly reduced by lidocaine pretreatment compared to magnesium sulfate and placebo ( p = 0.031 and p = 0.0003 , respectively ) .
CONCLUSIONS	In this double-blind , placebo-controlled , randomized trial , the combination of intravenous magnesium sulfate and lidocaine offered no additional benefit for the relief of propofol injection pain compared to intravenous lidocaine alone .
CONCLUSIONS	An improved , receptor-based understanding of the mechanism of propofol injection pain is still needed .

###24285605
BACKGROUND	This study was designed to evaluate the outcomes of alcohol septal ablation ( ASA ) under multicenter and multinational conditions .
METHODS	Data for 459 patients ( age 5713 years ) from nine European centers were prospectively collected and retrospectively analyzed .
RESULTS	ASA led to a significant reduction in outflow gradient ( PG ) and dyspnea [ median of PG from 88 ( 58-123 ) mm Hg to 21 ( 11-41 ) mm Hg ; median of NYHA class from 3 ( 2-3 ) to 1 ( 1-2 ) ; P < 0.01 ] .
RESULTS	The incidence of 3-month major adverse events ( death , electrical cardioversion for tachyarrhythmias , resuscitation ) and mortality was 2.8 % and 0.7 % , respectively .
RESULTS	Permanent pacemakers for post-ASA complete heart block were implanted in 43 patients ( 9 % ) .
RESULTS	Multivariate analysis identified higher amount of alcohol ( however , in generally low-dose procedures ) , higher baseline left ventricular ejection fraction and higher age as independent predictors of PG decrease 50 % .
CONCLUSIONS	The results of the first European multicenter and multinational study demonstrate that real-world early outcomes of ASA patients are better than was reported in observations from the first decade after ASA introduction .

###25135804
BACKGROUND	Inability to read instructions on drug labels has been identified among the Malaysian population since 1990 's .
OBJECTIVE	To assess the impact of font-enlarged and pictogram-incorporated labels used for long-term medications on patients ' adherence , comprehension and preferences .
METHODS	Outpatient pharmacy in one of the major general hospitals across Northern Malaysia .
METHODS	This was a three-arm , randomized controlled trial .
METHODS	Outpatients with refill prescriptions of selected oral antihypertensive or antidiabetic medications were screened for eligibility .
METHODS	They were randomly allocated with standard ( n = 35 ) , font-enlarged ( n = 40 ) or pictogram-incorporated ( n = 35 ) labels .
METHODS	Assessment of baseline adherence scores using the 8-item Morisky Medication Adherence Scale , comprehension scores using a structured questionnaire and preferences was conducted upon recruitment .
METHODS	Follow-up telephone interviews were conducted after 4 weeks .
METHODS	The changes of patients ' adherence and comprehension scores and their preferences .
RESULTS	Within-group comparisons demonstrated an increase of total adherence scores after 4 weeks in all three groups ( mean changes 0.35 , 0.58 and 0.67 ; p = 0.029 , 0.013 and 0.011 , respectively ) .
RESULTS	The repeatedly measured total comprehension score of pictogram-incorporated label group was significantly higher than baseline ( mean change 0.37 , p = 0.010 ) .
RESULTS	Two intervention groups obtained significantly higher scores for few items in both adherence and comprehension measurements after 4 weeks as compared with baselines .
RESULTS	As indicated by F tests , three groups did not significantly differ in the changes of both total adherence and comprehension scores ( p = 0.573 and 0.069 , respectively ) with the subjects ' age adjusted .
RESULTS	Elderlies and those with a higher number of morbidity preferred pictogram-incorporated label over font-enlarged label .
CONCLUSIONS	We did not find a significant change of both adherence and comprehension levels after the introduction of modified medication labels .
CONCLUSIONS	However , on the basis of within-group comparisons , they may have positive influences on certain aspects of patients ' adherence and comprehension .
CONCLUSIONS	Variations in preferences may reflect the unique need of different subgroups in receiving written medication instructions .

###25539240
OBJECTIVE	The purpose of this article is to evaluate the efficacy of IV hyoscine butylbromide as a bowel relaxant and automated carbon dioxide insufflation in CT colonography in terms of colonic distention and perceived burden .
OBJECTIVE	SUBJECTS AND METHODS ; Two hundred twenty-four participants were randomly allocated to one of four groups : control ( no bowel relaxant and IV saline placebo before CT colonography with manual carbon dioxide insufflation ) , hyoscine butylbromide ( IV hyoscine butylbromide before examination with manual carbon dioxide insufflation ) , automated ( no bowel relaxant before examination with automated carbon dioxide insufflation ) , and combined ( hyoscine butylbromide before examination with automated carbon dioxide insufflation ) .
OBJECTIVE	The degree of colonic distention on a 4-point scale , examination time , and participants ' satisfaction , as measured by their responses to a questionnaire , were assessed .
RESULTS	The mean distention grades of all the colonic segments and both positions were 3.22 in the control group , 3.28 in the hyoscine butylbromide group , 3.77 in the automated group , and 3.74 in the combined group .
RESULTS	Compared with manual carbon dioxide insufflation , automated carbon dioxide insufflation significantly improved the clinical adequacy of colonic distention and shortened examination time .
RESULTS	No statistically significant difference was seen in the clinical adequacy of distention between participants who received hyoscine butylbromide and those who did not , or in examination time .
RESULTS	Overall , the participants ' experiences were not different .
CONCLUSIONS	Colonic distention was statistically significantly improved by automated carbon dioxide insufflation , but not by the administration of hyoscine butylbromide .
CONCLUSIONS	The participants ' tolerance was similar in each group .

###24382338
BACKGROUND	Patients with mixed hyperlipidemia usually are in need of combination therapy to achieve low-density lipoprotein cholesterol ( LDL-C ) and triglyceride ( TG ) target values for reduction of cardiovascular risk .
BACKGROUND	This study investigated the efficacy and safety of adding a new hypolipidemic agent , coenzyme A ( CoA ) to stable statin therapy in patients with mixed hyperlipidemia .
METHODS	In this multi-center , 8-week , double-blind study , adults who had received 8 weeks of stable statin therapy and had hypertriglyceridemia ( TG level at 2.3-6 .5 mmol/L ) were randomized to receive CoA 400 U/d or placebo plus stable dosage of statin .
METHODS	Efficacy was assessed by the changes in the levels and patterns of lipoproteins .
METHODS	Tolerability was assessed by the incidence and severity of adverse events ( AEs ) .
RESULTS	A total of 304 patients with mixed hyperlipidemia were randomized to receive CoA 400 U/d plus statin or placebo plus statin ( n = 152 , each group ) .
RESULTS	After treatment for 8 weeks , the mean percent change in TG was significantly greater with CoA plus statin compared with placebo plus statin ( -25.9 % vs -4.9 % , respectively ; p = 0.0003 ) .
RESULTS	CoA plus statin was associated with significant reductions in TC ( -9.1 % vs -3.1 % ; p = 0.0033 ) , LDL-C ( -9.9 % vs 0.1 % ; p = 0.003 ) , and non - high-density lipoprotein cholesterol ( -13.5 % vs -5.7 % ; p = 0.0039 ) .
RESULTS	There was no significant difference in the frequency of AEs between groups .
RESULTS	No serious AEs were considered treatment related .
CONCLUSIONS	In these adult patients with persistent hypertriglyceridemia , CoA plus statin therapy improved TG and other lipoprotein parameters to a greater extent than statin alone and has no obviously adverse effect .
BACKGROUND	Current Controlled Trials ClinicalTrials.gov ID NCT01928342 .

###24818763
OBJECTIVE	The interferon-free regimen of ABT-450 ( a protease inhibitor ) , ritonavir , ombitasvir ( an NS5A inhibitor ) , dasabuvir ( a non-nucleoside polymerase inhibitor ) , and ribavirin has shown efficacy in patients with hepatitis C virus ( HCV ) genotype 1b infection-the most prevalent subgenotype worldwide .
OBJECTIVE	We evaluated whether ribavirin is necessary for ABT-450 , ritonavir , ombitasvir , and dasabuvir to produce high rates of sustained virologic response ( SVR ) in these patients .
METHODS	We performed a multicenter , open-label , phase 3 trial of 179 patients with HCV genotype 1b infection , without cirrhosis , previously treated with peginterferon and ribavirin .
METHODS	Patients were assigned randomly ( 1:1 ) to groups given ABT-450 , ritonavir , ombitasvir , and dasabuvir , with ribavirin ( group 1 ) or without ( group 2 ) for 12 weeks .
METHODS	The primary end point was SVR 12 weeks after treatment ( SVR12 ) .
METHODS	We assessed the noninferiority of this regimen to the rate of response reported ( 64 % ) for a similar population treated with telaprevir , peginterferon , and ribavirin .
RESULTS	Groups 1 and 2 each had high rates of SVR12 , which were noninferior to the reported rate of response to the combination of telaprevir , peginterferon , and ribavirin ( group 1 : 96.6 % ; 95 % confidence interval , 92.8 % -100 % ; and group 2 : 100 % ; 95 % confidence interval , 95.9 % -100 % ) .
RESULTS	The rate of response in group 2 was noninferior to that of group 1 .
RESULTS	No virologic failure occurred during the study .
RESULTS	Two patients ( 1.1 % ) discontinued the study owing to adverse events , both in group 1 .
RESULTS	The most common adverse events in groups 1 and 2 were fatigue ( 31.9 % vs 15.8 % ) and headache ( 24.2 % vs 23.2 % ) , respectively .
RESULTS	Decreases in hemoglobin level to less than the lower limit of normal were more frequent in group 1 ( 42.0 % vs 5.5 % in group 2 ; P < .001 ) , although only 2 patients had hemoglobin levels less than 10 g/dL .
CONCLUSIONS	The interferon-free regimen of ABT-450 , ritonavir , ombitasvir , and dasabuvir , with or without ribavirin , produces a high rate of SVR12 in treatment-experienced patients with HCV genotype 1b infection .
CONCLUSIONS	Both regimens are well tolerated , as shown by the low rate of discontinuations and generally mild adverse events .
CONCLUSIONS	ClinicalTrials.gov number : NCT01674725 .

###25363101
OBJECTIVE	This study compared the efficacy of risperidone monotherapy with risperidone plus valproate in bipolar I disorder , manic phase .
OBJECTIVE	Some studies showed the efficacy of risperidone monotherapy in the treatment of bipolar disorder , so we examined this effectiveness in this clinical-trial study .
METHODS	This 7-week , randomized , single-blind study included 48 bipolar I inpatients manic phase without psychotic features divided in risperidone group ( n = 23 ) and risperidone plus sodium valproate group ( n = 25 ) .
METHODS	According to clinical symptoms , 3 categories : complete remission , partial remission and no remission were mentioned in weekly follow-up .
METHODS	Remission rate compared with survival analysis .
RESULTS	The results showed a significant difference in remission rate between risperidone monotherapy and risperidone plus sodium valproate at the 1st , 2nd and the 3rd week ( p = 0.012 , 0.023 , 0.027 respectively ) , It means the remission rate in risperidone plus valproate group was higher in the first three weeks , but at the end of the seventh week , the difference was not statistically significant .
RESULTS	There was no significant difference between the two groups in the development of adverse effects .
CONCLUSIONS	Risperidone can be effective and well tolerated in both acute manic episodes of bipolar mood disorders .

###25179038
BACKGROUND	Mediastinitis costs hospitals thousands of dollars a year and increases the incidence of patient morbidity and mortality .
BACKGROUND	No studies have been done to evaluate adenosine triphosphate ( ATP ) counts on disposable and nondisposable electrocardiography ( ECG ) lead wires in pediatric patients .
OBJECTIVE	To compare the cleanliness of disposable and nondisposable ECG lead wires in postoperative pediatric cardiac surgery patients by measuring the quantity of ATP ( in relative luminescence units [ RLUs ] ) .
OBJECTIVE	ATP levels correlate with microbial cell counts and are used by institutions to assess hospital equipment and cleanliness .
METHODS	A prospective , randomized trial was initiated with approval from the institutional review board .
METHODS	Verbal consent was obtained from the parents/guardians for each patient .
METHODS	Trained nurses performed ATP swabs on the right and left upper ECG cables on postoperative days 1 , 2 , and 3 .
RESULTS	This study enrolled 51 patients .
RESULTS	The disposable ECG lead wire ATP count on postoperative day 1 ( median , 157 RLUs ) was significantly lower ( P < .001 ) than the count for nondisposable ATP lead wires ( median , 610 RLUs ) .
RESULTS	On postoperative day 2 , the ATP count for the disposable ECG lead wires ( median , 200 RLUs ) was also lower ( P = .06 ) than the count for the nondisposable ECG lead wires ( median , 453 RLUs ) .
CONCLUSIONS	Results of this study support the use of disposable ECG lead wires in postoperative pediatric cardiac surgery patients for at least the first 48 hours as a direct strategy to reduce the ATP counts on ECG lead wires .

###25880207
OBJECTIVE	Ripasudil hydrochloride hydrate ( K-115 ) , a novel rho kinase inhibitor , provides statistically significant intraocular pressure ( IOP ) - lowering effects and has a tolerable safety profile .
OBJECTIVE	However , no studies have evaluated ripasudil combined with - blockers and prostaglandin analogues .
OBJECTIVE	To evaluate the additive IOP-lowering effects and the safety of ripasudil , 0.4 % , combined with timolol , 0.5 % , or latanoprost , 0.005 % , in patients with primary open-angle glaucoma or ocular hypertension .
METHODS	We conducted 2 , multicenter , randomized , double-masked , parallel group comparison studies of ripasudil-timolol and ripasudil-latanoprost in 29 and 36 Japanese clinical centers , respectively .
METHODS	Analyses were performed on an intention-treat-treat basis .
METHODS	After appropriate run-in periods with timolol or latanoprost , 208 and 205 patients whose IOP levels were 18 mm Hg or higher were enrolled in the ripasudil-timolol and ripasudil-latanoprost groups , respectively .
METHODS	Enrollment began December 1 , 2011 , and follow-up was completed on September 7 , 2012 , in the ripasudil-timolol study .
METHODS	Enrollment began December 1 , 2011 , and follow-up was completed on September 27 , 2012 , in the ripasudil-latanoprost study .
METHODS	Patients were subdivided into 2 groups in each study and were treated with ripasudil or placebo twice daily for 8 weeks .
METHODS	The IOP reductions in the ripasudil and placebo groups were analyzed with a repeated-measures analysis of variance model at weeks 4 , 6 , and 8 , at trough ( before instillation [ 9 am ] ) and peak ( 2 hours after instillation [ 11 am ] ) levels .
RESULTS	In the ripasudil-timolol study , the mean IOP reductions from baseline in the ripasudil and placebo groups were -2.4 and -1.5 mm Hg at 9 am for a difference of 0.9 mm Hg ( 95 % CI , 0.4-1 .3 mm Hg ; P < .001 ) and -2.9 and -1.3 mm Hg at 11 am for a difference of 1.6 mm Hg ( 95 % CI , 1.1-2 .1 mm Hg ; P < .001 ) , respectively .
RESULTS	In the ripasudil-latanoprost study , those IOP reductions were -2.2 and -1.8 mm Hg at 9 am for a difference of 0.4 mm Hg ( 95 % CI , -0.0 to 0.9 mm Hg ; P = .06 ) and -3.2 and -1.8 mm Hg at 11 am for a difference of 1.4 mm Hg ( 95 % CI , 0.9-1 .9 mm Hg ; P < .001 ) , respectively .
RESULTS	The most frequently reported adverse event was conjunctival hyperemia , which was mild and in most cases resolved without treatment before the next instillation .
CONCLUSIONS	These clinical trials found additive IOP-lowering effects of ripasudil from placebo at trough and peak levels in combination with timolol and at peak level in combination with latanoprost .
CONCLUSIONS	However , a definitive difference in the addition of placebo to latanoprost was not identified in the trough level .
BACKGROUND	clinicaltrials.jp Identifiers : JAPIC111700 and JAPIC111701 .

###25425297
OBJECTIVE	Two single-dose studies were conducted in Japan and Europe to compare the pharmacokinetic ( PK ) and pharmacodynamic ( PD ) profiles of new insulin glargine 300U/ml ( Gla-300 ) and insulin glargine 100U/ml ( Gla-100 ) in people with type 1 diabetes mellitus .
METHODS	In two double-blind , randomized , crossover studies , 18 Japanese participants ( aged 20-65years ) and 24 European participants ( aged 18-65years ) with glycated haemoglobin levels 9.0 % ( 75mmol/mol ) received single subcutaneous doses of Gla-300 , 0.4 , 0.6 and 0.9 U/kg ( 0.9 U/kg in the European study only ) , and Gla-100 , 0.4 U/kg .
METHODS	A 36-h euglycaemic clamp procedure was performed after each dosing .
RESULTS	The serum insulin glargine concentration ( INS ) and glucose infusion rate ( GIR ) developed more gradually into more constant and prolonged profiles with Gla-300 than with Gla-100 .
RESULTS	In support of this , the times to 50 % of glargine exposure and insulin activity were longer for all Gla-300 doses than for Gla-100 during the 36-h clamp period , indicating a more evenly distributed exposure and metabolic effect beyond 24h .
RESULTS	Exposure to insulin glargine and glucose utilization were lower with the 0.4 and 0.6 U/ml Gla-300 doses in both studies compared with the 0.4 U/ml Gla-100 dose .
RESULTS	Glucose-lowering activity was detected for up to 36h with all doses of Gla-300 .
CONCLUSIONS	Single-dose injections of Gla-300 present more constant and prolonged PK and PD profiles compared with Gla-100 , maintaining blood glucose control for up to 36h in euglycaemic clamp settings in Japanese and European participants with type 1 diabetes .

###24692301
OBJECTIVE	To investigate whether methotrexate ( MTX ) use , as compared to other therapies , and erythrocyte methotrexate polyglutamate ( MTXGlu ) concentrations are associated with changes in glycosylated hemoglobin ( HbA1c ) levels in rheumatoid arthritis ( RA ) patients .
METHODS	The derivation cohort consisted of patients selected from the Treatment in the Rotterdam Early Arthritis Cohort who fulfilled the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for RA .
METHODS	Patients were randomized to 6 treatment arms : triple disease-modifying antirheumatic drug ( DMARD ) therapy ( consisting of MTX , sulfasalazine , and hydroxychloroquine [ HCQ ] ) + intramuscular ( IM ) glucocorticoids , triple DMARD therapy + oral glucocorticoids , MTX + oral glucocorticoid therapy , MTX therapy , oral glucocorticoid therapy , and HCQ therapy .
METHODS	HbA1c levels were determined at baseline and at 3 months .
METHODS	Concentrations of erythrocyte MTXGlu1-5 were measured after 3 months of treatment .
METHODS	Within treatment arms , changes in the level of HbA1c were compared by paired t-test .
METHODS	Associations of MTXGlu concentrations with changes in the level of HbA1c were tested using multiple linear regression analysis , adjusted for age , sex , body mass index , and comedication .
METHODS	Significant associations were validated using data on RA patients taking MTX who were enrolled in the Methotrexate in Rotterdam cohort .
RESULTS	In the derivation cohort , the mean change in HbA1c level after 3 months of treatment was -1.9 mmoles/mole ( -0.18 % ) ( P = 0.001 ) .
RESULTS	Levels of HbA1c decreased in 4 of the individual treatment groups , as follows : for the triple DMARD therapy + IM glucocorticoids treatment arm , -5.5 mmoles/mole ( -0.50 % ) ( P < 0.001 ) , for the triple DMARD therapy + oral glucocorticoids treatment arm , -3.7 mmoles/mole ( -0.34 % ) ( P < 0.001 ) , for the MTX treatment arm , -0.8 mmoles/mole ( -0.08 % ) ( P = 0.018 ) , and for the HCQ treatment arm , -2.0 mmoles/mole ( -0.19 % ) ( P = 0.175 ) .
RESULTS	Increased levels of MTXGlu2 ( = -0.20 , P = 0.005 ) , MTXGlu3 ( = -0.31 , P < 0.001 ) , MTXGlu4 ( = -0.33 , P < 0.001 ) after treatment , MTXGlu5 ( = -0.39 , P < 0.001 ) , and total MTXGlu ( = -0.29 , P < 0.001 ) were associated with decreased levels of HBA1c .
RESULTS	In the validation cohort , levels of HbA1c were decreased by 2.6 mmoles/mole ( 0.23 % ) ( P < 0.001 ) after treatment , and MTXGlu3 was associated with decreased levels of HbA1c ( = -0.26 , P = 0.018 ) .
CONCLUSIONS	MTX use and higher concentrations of erythrocyte MTXGlu are associated with decreased levels of HbA1c in RA patients .
CONCLUSIONS	Triple DMARD therapy and HCQ treatment resulted in reduced HbA1c levels , and glucocorticoid treatment resulted in increased levels of HbA1c .

###25425377
OBJECTIVE	To evaluate the accuracy of sonographic classification of chorionicity in a large cohort of twins and investigate which factors may be associated with sonographic accuracy .
METHODS	We conducted a secondary analysis of a randomized trial of preterm birth prevention in twins .
METHODS	Sonographic classification of chorionicity was compared with pathologic examination of the placenta .
METHODS	Maternal ( age , body mass index , diabetes , and hypertension ) , obstetric ( prior cesarean delivery , gestational age at the first sonographic examination , and antepartum bleeding ) , and sonographic ( oligohydramnios , polyhydramnios , and twin-twin transfusion syndrome ) factors were assessed for their possible association with accuracy .
RESULTS	A total of 545 twin sets in which chorionicity was classified by sonography before 20 weeks ' gestation were included ; 455 were dichorionic and 90 were monochorionic based on pathologic examination .
RESULTS	Sonography misclassified 35 of 545 twin pregnancies ( 6.4 % ) : 18 of 455 dichorionic twins ( 4.0 % ) and 17 of 90 monochorionic twins ( 19.0 % ) .
RESULTS	The sensitivity and specificity of sonographic diagnosis of monochorionicity were 81.1 % and 96.0 % , respectively .
RESULTS	In a multivariable analysis , pregnancies with initial sonographic examinations before 14 weeks ' gestation were less likely to have misclassified chorionicity than those with sonographic examinations at 15 to 20 weeks ( odds ratio [ OR ] , 0.47 ; 95 % confidence interval [ CI ] , 0.23-0 .96 ) .
RESULTS	For each week increase in gestational age , the odds of misclassification rose by 10 % ( OR , 1.10 ; 95 % CI , 1.01-1 .2 ) .
RESULTS	In the multivariable analysis , maternal age , body mass index , parity , and prior cesarean delivery were not associated with sonographic accuracy .
CONCLUSIONS	Sonography before 20 weeks incorrectly classified chorionicity in 6.4 % of twin gestations .
CONCLUSIONS	Those with first sonographic examinations performed at earlier gestational ages had improved chorionicity diagnosis .

###25415695
OBJECTIVE	The purpose of this study was to investigate and validate adaptation of a cardiovascular CT angiography contrast injection protocol for lower tube potential .
METHODS	Eighty-three patients evaluated for thoracic aortic disease with a 256-MDCT scanner were imaged at 120 kV ( group 1 ) or 100 kV ( group 2 ) with the same contrast protocol ( 90 mL iopromide 370 mg I/mL at 3.5 mL/s ) .
METHODS	A pharmacokinetic model was validated and used to simulate aortic attenuation in group 2 patients with 20 % , 33 % , and 44 % reduction in contrast volume .
METHODS	A 44 % volume reduction was applied to 50 additional patients who underwent imaging at 100 kV ( group 3 ) .
METHODS	Patient characteristics , scanning and radiation parameters , and objective and subjective image indexes were compared among groups .
RESULTS	Group 2 patients had higher mean aortic blood attenuation ( 39961 HU ) than group 1 patients ( 28148 HU ) ( p < 0.001 ) but similar image noise .
RESULTS	Group 3 and group 1 patients had similar mean aortic attenuation and noise .
RESULTS	Subjective assessment of image quality indicated that group 3 and group 1 had comparable percentages of images with good or excellent diagnostic confidence scores ( reader 1 , 98 % vs 96 % ; reader 2 , 96 % vs 96 % ) .
CONCLUSIONS	Lower tube potential ( 100 kV ) for cardiothoracic CT could be accompanied by a 44 % reduction in contrast volume with satisfactory aortic blood-pool attenuation in most patients .
CONCLUSIONS	More personalized adaptation of the contrast protocol that takes into account patient characteristics and tube potential is necessary to ensure sufficient contrast enhancement for all patients .

###25955224
BACKGROUND	A low response to controlled ovarian hyperstimulation implies a reduced number of embryos and impaired pregnancy rate .
BACKGROUND	Follicular priming with steroids before controlled ovarian hyperstimulation has been suggested to improve the subsequent ovarian response .
OBJECTIVE	The purpose of this study was to determine the best follicular priming protocol in low responders and to investigate the intrafollicular mechanisms triggered by steroid hormone priming .
METHODS	This was a single-center , randomized , parallel , open-label , controlled trial , in two phases .
METHODS	The setting was a university-based in vitro fertilization unit .
METHODS	Potential low responders ( n = 99 ) underwent a first intracytoplasmic sperm injection cycle .
METHODS	Confirmed low responders ( n = 66 ) were randomized to different priming protocols before a new intracytoplasmic sperm injection .
METHODS	Randomized patients underwent one of the following priming strategies : transdermal testosterone ( 20 g/kg/d ) , transdermal estradiol ( 200 g/d ) , or combined estrogens and oral contraceptive pills ( 30 g of ethinyl estradiol plus 150 g of desogestrel administered during the luteal phase of two consecutive cycles ) and 4 mg/d of estradiol valerate during the follicular phase between them .
METHODS	Metaphase II ( MII ) oocytes were retrieved .
METHODS	Gene expression levels in the granulosa cells of steroidogenesis enzymes and FSH , LH , and androgen receptors were measured .
RESULTS	The number of retrieved MII oocytes did not differ between the interventional groups ( testosterone , 2.2 2.0 ; estrogen , 2.7 1.7 ; and combined estrogens and oral contraceptive pills , 2.0 1.3 ; not significant ) .
RESULTS	Compared with those in nonprimed cycles , estradiol pretreatment yielded more MII oocytes ( primed , 2.7 1.7 ; nonprimed , 1.6 1.2 ; P = .029 ) although the clinical pregnancy rate was higher in patients treated with testosterone ( P = .003 ) .
RESULTS	Testosterone pretreatment increased androgen receptor expression ( P = .028 ) compared with that for the previous cycle without priming .
CONCLUSIONS	The results of the present trial do not support the superiority of one priming strategy over the others .

###25359150
BACKGROUND	Tumor necrosis factor ( TNF ) and , possibly , lymphotoxin alpha ( LT ) signaling contribute to inflammation and rheumatoid arthritis ( RA ) pathogenesis .
BACKGROUND	Pateclizumab ( anti-lymphotoxin - alpha ; MLTA3698A ) is a humanized monoclonal antibody that blocks and depletes anti-LT .
BACKGROUND	This phase 2 , randomized , head-to-head , active - and placebo-controlled trial examined the safety and efficacy of pateclizumab compared to adalimumab in RA patients with an inadequate response to disease-modifying antirheumatic drugs ( DMARD-IR ) .
METHODS	Patients ( n = 214 ) with active RA ( 6 swollen and tender joints , C-reactive protein 10 mg/L ) on oral DMARDs were randomized ( 2:2:1 ) to receive pateclizumab 360 mg , adalimumab 40 mg , or placebo subcutaneously every 2 weeks .
METHODS	The primary endpoint , 4-variable , 28-joint disease activity score erythrocyte sedimentation rate ( DAS28 ( 4 ) - ESR ) response , was evaluated at 12 weeks using an analysis of covariance ( ANCOVA ) model with adjustments for concomitant DMARD use and geographic region .
METHODS	Secondary efficacy endpoints included American College of Rheumatology ( ACR ) 20 , ACR50 , and ACR70 responses at Day 85 .
METHODS	Pharmacokinetics , pharmacodynamics , and immunogenicity of pateclizumab were assessed .
RESULTS	Pateclizumab reduced the DAS28 ( 4 ) - ESR response ( -1.89 ) at 12 weeks , however , this did not reach statistical significance compared to placebo ( -1.54 ) , while adalimumab ( -2.52 ) differed significantly from both placebo and pateclizumab .
RESULTS	Pateclizumab 12-week ACR20 , ACR50 and ACR70 response rates ( 64 % , 33 % , and 14 % ) suggested clinical activity but were not statistically significant compared to placebo rates ( 46 % , 24 % , and 8 % , respectively ) .
RESULTS	CXCL13 serum levels decreased significantly following pateclizumab and adalimumab administration , demonstrating pharmacological target engagement by both drugs .
RESULTS	Overall , adverse events ( AEs ) were comparable among all cohorts .
RESULTS	Infections were the most common AE , occurring with comparable frequency in all groups .
RESULTS	Serious AEs occurred in 0 % of pateclizumab , 5.9 % of adalimumab , and 2.3 % of placebo patients , with serious infection in 2.3 % of adalimumab patients and none in pateclizumab and placebo patients .
CONCLUSIONS	Pateclizumab had a good safety profile in patients inadequately responsive to DMARDs , but no statistically significant improvement in RA signs and symptoms after 12 weeks of treatment .
CONCLUSIONS	Adalimumab demonstrated efficacy and safety comparable to published results in this head-to-head comparison in DMARD-IR RA patients .
BACKGROUND	ClinicalTrials.gov NCT01225393 , Registered 18 October 2010 .

###25046945
OBJECTIVE	To observe the effect and safety of plastering Chinese Compound Shenhuang Ointment ( CSO ) at Shenque ( RN8 ) in promoting the rehabilitation of postoperative gastrointestinal dysfunction patients of qi stagnation blood stasis syndrome ( QSBSS ) .
METHODS	A prospective , multi-centered , randomized , double-blinded , controlled trial was conducted in 220 postoperative gastrointestinal dysfunction patients of QSBSS .
METHODS	They were randomly assigned to two groups , the CSO group ( 110 cases ) and the placebo group ( 110 cases ) .
METHODS	CSO was plastered at Shenque ( RN8 ) for 5 days after operation .
METHODS	The time of exhaustion , defecation , the recovery of intestinal peristalsis , integrals of TCM syndrome , and serum levels of motilin ( MOT ) and somatostatin ( SS ) were observed .
RESULTS	Compared with the placebo group , the condition of exhaustion and defecation , the recovery of intestinal peristalsis on the 3rd day after operation was all improved ( P < 0.05 ) .
RESULTS	The integrals of TCM syndrome at day 2 , 3 , and 4 were more significantly lowered in the CSO group than in the placebo group ( P < 0.01 , P < 0.05 ) .
RESULTS	The total effective rate of TCM syndrome was 95.3 % in the CSO group , better than that in the placebo group ( 91.8 % , P < 0.05 ) .
RESULTS	Compared with the placebo group , the serum MOT level increased and the serum SS level decreased at day 5 after operation in the CSO group ( P < 0.05 ) .
CONCLUSIONS	The plastering of CSO at Shenque ( RN8 ) could advance the time of exhaustion and defecation , and improve patients ' clinical symptoms .
CONCLUSIONS	And patients could tolerate well .

###24534303
OBJECTIVE	To investigate the feasibility of bilateral thoracic paravertebral block for postoperative analgesia in patients after off-pump coronary artery bypass grafting ( OPCABG ) .
METHODS	Upon the approval of institutional Ethics Committee and informed consent , forty patients ASAII or III aged 52-77 yr with BMI ( body mass index ) < 30 kg/m ( 2 ) , undergoing OPCABG , were randomly divided by random numbers into two groups ( n = 20 each ) : thoracic paravertebral block for postoperative analgesia group ( group P ) and patient-controlled intravenous analgesia ( PCIA ) group ( group I ) .
METHODS	Bilateral thoracic paravertebral block and insertion epidural catheter were performed at T3 , 4 interspace prior to induction of anesthesia in group P.
METHODS	At the end of the operation , an infusion of 0.375 % ropivacaine was injected at the rate of 5 ml/h up to 48 h.Group I received PCIA with morphine .
METHODS	Dermatomes of hypoalgesia in group P were recorded .
METHODS	The following indexes were recorded at 12 , 24 , 36 and 48 hours after postoperative analgesia beginning : VAS scores of rest pain , cough pain and sedation score .
METHODS	To evaluate stability of circulation .
METHODS	Cycle time , complications and side effects after operation were recorded .
RESULTS	Dermatomes of hypoalgesia was 5.1 1.0 segments in group P. VAS scores of rest pain ( 2.4 0.4 , 2.6 0.5 , 2.4 0.4 , 2.2 0.3 vs 3.7 0.7 , 3.6 0.8 , 3.4 0.6 , 3.1 0.6 , all P < 0.01 ) , cough pain ( 3.7 0.8 , 3.9 1.0 , 3.8 1.1 , 3.8 0.9 vs 4.4 1.1 , 4.9 1.3 , 4.8 1.3 , 4.3 1.2 , P < 0.05 , < 0.01 ) and sedation scores ( 2.2 0.4 , 2.0 0.4 , 1.9 0.3 , 1.8 0.3 , 2.6 0.5 , 2.5 0.4 , 2.4 0.5 , 2.2 0.4 , P < 0.05 ) in group P were significantly lower than in group I at the four points .
RESULTS	The incidences of sinus tachycardia ( 5 % vs 25 % ) and hypertension ( 0 vs 30 % ) in group P were significantly reduced than in group I ( P < 0.05 ) , and there were no significant difference in the incidences of sinus brachycardia ( 30 % vs 15 % ) and hypotension ( 20 % vs 10 % ) ( P > 0.05 ) .
RESULTS	Compared with group I , extubation time ( 5.5 1.4 vs 7.1 1.7 ) and residence time in ICU ( 17.3 4.2 vs 21.4 5.8 ) were shortened significantly in group P ( P < 0.05 ) , and there were no significant difference in length of stay after operation ( 10.5 2.6 vs 11.7 2.8 , P > 0.05 ) .
RESULTS	The incidence rate of nausea in group P was significantly lower than in group I ( 5 % vs 25 % , P < 0.05 ) , and there were no significant difference in the other complications and side effects after operation ( P > 0.05 ) .
CONCLUSIONS	Bilateral thoracic paravertebral block for postoperative analgesia could be used safely and efficiently and accelerate the cycle time in patients after OPCABG .

###24975467
BACKGROUND	Bone loss and subclinical diabeteslike are developed during long-term spaceflight .
BACKGROUND	Recently , it was demonstrated that bone was able to regulate energy metabolism and testosterone synthesis via osteocalcin .
BACKGROUND	The aim of this study was to determine whether serum osteocalcin level is associated with glycolipid metabolism or testosterone under the influence of microgravity with or without resistive vibration exercise ( RVE ) .
METHODS	A total of 14 healthy adult male volunteers ( 25-40years ) were randomly assigned to two groups ( n = 7 each ) : control ( CON ) group and RVE group .
METHODS	Radioimmunoassay kits and ELISA kits were used for measurement of serum indices .
RESULTS	During 60-day bed rest , serum osteocalcin of both groups increased at day 4 during bed rest .
RESULTS	Serum OPG started decreasing and reached its lowest value at day 30 during bed rest .
RESULTS	In control group , serum insulin increased at day 4 during bed rest .
RESULTS	IGF-I did not change significantly during the entire period of bed rest .
RESULTS	The serum glucose decline 10 % and 14 % in CON and RVE groups at day 4 during bed rest .
RESULTS	Relatively , the same results as glucose were found in serum HDL and LDL for both groups .
RESULTS	Leptin rose and became highest at day 60 during bed rest in both groups .
RESULTS	The level of serum testosterone was declined in control group at day 4 during bed rest .
RESULTS	Cortisol kept stable in both group during bed rest .
RESULTS	By spearman correlation analysis , serum osteocalcin was significantly associated with serum insulin ( P < 005 ) , LDL ( P < 001 ) and Leptin ( P < 001 ) .
CONCLUSIONS	Our findings suggested that the mutual regulation may exist between skeletal and energy metabolism under simulated microgravity .

###25227540
BACKGROUND	Segmental muscle vibration ( SMV ) improves motor performances in neurological conditions , including stroke .
OBJECTIVE	To determine if SMV modifies upper limb muscular activity in chronic stroke patients performing a reaching movement .
METHODS	We randomized 22 chronic stroke patients to an experimental group ( EG ; n = 12 ) , receiving 10 sessions of exercise + 120 Hz SMV over the biceps brachii ( BB ) and the flexor carpi ulnaris ( FCU ) muscles , or to a control group ( CG ; n = 10 ) receiving exercise only .
METHODS	All subjects performed a reaching movement with the affected side before and 4 weeks after therapy ended .
METHODS	We recorded surface EMG activity of the anterior deltoid ( AD ) , posterior deltoid ( PD ) , BB , triceps brachii ( TB ) , FCU and extensor carpi radialis ( ECR ) muscles .
METHODS	We calculated muscular onset times , modulation ratio , co-contractions and degree of contraction .
RESULTS	After SMV , onset times of the PD ( p = 0.03 ) , BB ( p = 0.02 ) and ECR ( p = 0.04 ) in the EG were less anticipated than at baseline ; the modulation ratio increased in AD ( p = 0.003 ) and BB ( p = 0.01 ) ; co-contractions decreased in the pairs BB/TB ( p = 0.007 ) , PD/BB ( p = 0.004 ) and AD/BB ( p = 0.01 ) ; and the degree of contraction decreased in BB ( p = 0.01 ) .
CONCLUSIONS	The modulation of muscular function induced by SMV may aid to explain its action on smoothness and coordination of movements .

###24991908
OBJECTIVE	The objective of this study is to assess the efficacy of an intervention designed to promote resilience in young children living with their HIV-positive mothers .
METHODS	HIV-positive women attending clinics in Tshwane , South Africa , and their children , aged 6-10 years , were randomized to the intervention ( I ) or standard care ( S ) .
METHODS	The intervention consisted of 24 weekly group sessions led by community care workers .
METHODS	Mothers and children were in separate groups for 14 sessions , followed by 10 interactive sessions .
METHODS	The primary focus was on parent-child communication and parenting .
METHODS	Assessments were completed by mothers and children at baseline and 6 , 12 and 18 months .
METHODS	Repeated mixed linear analyses were used to assess change over time .
RESULTS	Of 390 mother-child pairs , 84.6 % ( I : 161 and S : 169 ) completed at least two interviews and were included in the analyses .
RESULTS	Children 's mean age was 8.4 years and 42 % of mothers had been ill in the prior 3 months .
RESULTS	Attendance in groups was variable : only 45.7 % attended more than 16 sessions .
RESULTS	Intervention mothers reported significant improvements in children 's externalizing behaviours ( = -2.8 , P = 0.002 ) , communication ( = 4.3 , P = 0.025 ) and daily living skills ( = 5.9 , P = 0.024 ) , although improvement in internalizing behaviours and socialization was not significant ( P = 0.061 and 0.052 , respectively ) .
RESULTS	Intervention children reported a temporary increase in anxiety but did not report differences in depression or emotional intelligence .
CONCLUSIONS	This is the first study demonstrating benefits of an intervention designed to promote resilience among young children of HIV-positive mothers .
CONCLUSIONS	The intervention was specifically designed for an African context and has the potential to benefit large numbers of children , if it can be widely implemented .

###25293888
BACKGROUND	Data about the vaccination status of participants are required in epidemiological cohort studies whenever infection or immunity is considered as potential exposure or outcome .
BACKGROUND	Within Pretest 2 of the German National Cohort ( GNC ) we therefore investigated the acceptance and feasibility of extracting vaccination status from vaccination certificates provided by the participants of the study .
METHODS	This study was conducted in three study centers ( Bremen , n = 73 ; Hamburg , n = 200 ; Hannover , n = 193 ) .
METHODS	In order to test if an additional reminder would prevent participants from forgetting their vaccination certificates at home persons willing to participate in Pretest 2 were randomly assigned to one of three invitation groups ( IG ) .
METHODS	About one third of the participants received either no further reminder ( IG1 ) , a reminder card together with the appointment letter ( IG2 ) or a separate reminder card 4 days before the appointment ( IG3 ) .
METHODS	At the study center , vaccination data were scanned or copied and entered into a database using a unique identification number .
METHODS	Participants were also asked to fill in a short questionnaire to assess the completeness of the provided vaccination data .
METHODS	Additionally , in one of the three participating study centers , general practitioners ( GP ) were asked to provide vaccination data from their records following respective participants ' consent .
METHODS	Finally , we compared the influenza data from the vaccination certificates with the influenza data obtained from participants in Pretest 2 by use of a self-administered questionnaire ( ID-Screen ) .
RESULTS	Due to different starting dates of the study the intended reminder procedure was implemented only in Hamburg and Hannover .
RESULTS	In Hamburg , significantly more vaccination certificates were submitted by the group which received the reminder card separately 4 days before the examination ( IG3 ) compared to IG1 and IG2 ( p = 0.04 ) .
RESULTS	In Hannover , in contrast , most vaccination certificates were brought by those who received the reminder card together with the appointment letter .
RESULTS	Overall , the use of a reminder card had a positive but not significant effect as 89 % ( 185/209 ) of participants who received the reminder card submitted vaccination data versus 81 % ( 84/104 ) of participants who did not receive any reminder card ( p = 0.06 ) .
RESULTS	Of all Pretest 2 participants in Hannover , 62 % ( 120/193 ) gave written consent for data collection by the GPs .
RESULTS	In total , 114 practices were contacted of which 49 ( 43 % ) sent vaccination data .
RESULTS	All in all , 360 vaccination certificates with 5065 documented vaccinations were entered into a database , of which 4830 ( 95 % ) were valid for analysis covering a period from 1946 to 2012 .
RESULTS	The comparison of influenza vaccination data from vaccination certificates to the remembered data from a self-completed questionnaire showed an agreement of data in 46 % ( 84/184 ) of cases ( Kappa = 0.48 ) .
RESULTS	Influenza vaccinations were underreported in 4 % ( 7/170 ) of self-completed questionnaires .
CONCLUSIONS	The reliable documentation of vaccinations within the context of the GNC proved to be feasible and thus recommendable at a large scale within the GNC as participants showed high willingness and compliance in providing available vaccination documents .
CONCLUSIONS	An additional validation by means of documents provided by physicians seems to be possible for more than a quarter of participants .
CONCLUSIONS	In order to maximize the likelyhood of participants ' of bringing their vaccination certificates it would be sufficient to send a reminder card together with the appointment letter .

###24433229
BACKGROUND	Successful recruitment and retention of participants into research studies is critical for optimising internal and external validity .
BACKGROUND	Research into diet and lifestyle of young women is important due to the physiological transitions experienced at this life stage .
BACKGROUND	This paper aims to evaluate data related to recruitment and retention across three research studies with young women , and present practical advice related to recruiting and retaining young women in order to optimise study quality within nutrition research .
METHODS	Recruitment and retention strategies used in three nutrition studies that targeted young women ( 18 to 35 years ) were critiqued .
METHODS	A randomised controlled trial ( RCT ) , a crossover validation study and a cross-sectional survey were conducted at the University of Newcastle , Australia between 2010 and 2013Successful recruitment was defined as maximum recruitment relative to time .
METHODS	Retention was assessed as maximum participants remaining enrolled at study completion .
RESULTS	Recruitment approaches included notice boards , web and social network sites ( Facebook and Twitter ) , with social media most successful in recruitment .
RESULTS	The online survey had the highest recruitment in the shortest time-frame ( 751 participants in one month ) .
RESULTS	Email , phone and text message were used in study one ( RCT ) and study two ( crossover validation ) and assisted in low attrition rates , with 93 % and 75.7 % completing the RCT and crossover validation study respectively .
RESULTS	Of those who did not complete the RCT , reported reasons were : being too busy ; and having an unrelated illness .
CONCLUSIONS	Recruiting young women into nutrition research is challenging .
CONCLUSIONS	Use of social media enhances recruitment , while Email , phone and text message contact improves retention within interventions .
CONCLUSIONS	Further research comparing strategies to optimise recruitment and retention in young women , including flexible testing times , reminders and incentives is warranted .

###25047001
BACKGROUND	Approximately 85 % of vaginal deliveries are accompanied by perineal trauma .
BACKGROUND	The objective of this trial is to compare the incidence and degree of perineal trauma after primary delivery of the anterior compared with the posterior shoulder during vaginal birth .
BACKGROUND	The hypothesis is that primary delivery of the posterior shoulder reduces the rate and degree of perineal trauma .
METHODS	This is a single-centre , randomized controlled trial , with computer-generated randomization in a 1:1 allocation ratio .
METHODS	Women planning their first vaginal delivery ( n = 650 ) are randomized to primary delivery of either the anterior or posterior shoulder .
METHODS	The primary outcome is any perineal trauma .
METHODS	Additional outcomes are the perineal injury subtypes , postpartum bleeding , umbilical artery pH , Apgar score at 5minutes and any neonatal birth trauma .
METHODS	Perineal trauma is assessed by a midwife or doctor blinded to the method of shoulder delivery .
METHODS	All midwives are trained in the two methods of shoulder delivery and in the grading of perineal tears .
METHODS	The trial is being undertaken at a Danish community hospital with 1,600 yearly deliveries .
METHODS	Data will be analyzed according to the intention-to-treat principle .
METHODS	Recruitment started in January 2013 and the trial is planned to proceed for 24months .
CONCLUSIONS	Most delivery assistance techniques are based on tradition and heritage and lack objective evidence .
CONCLUSIONS	This trial provides an example of how vaginal delivery techniques can be evaluated in a randomized controlled trial .
CONCLUSIONS	The results of this trial will clarify the role that delivery of the shoulders has on perineal trauma and thereby provide knowledge to recommendations on birthing technique .
BACKGROUND	ClinicalTrials.gov : NCT01937546 .

###25459687
BACKGROUND	We investigated the effects of intracoronary transplantation of CD34 ( + ) cells on myocardial perfusion in patients with nonischemic dilated cardiomyopathy ( DCM ) .
RESULTS	We enrolled 21 patients with DCM ( left ventricular ejection fraction [ LVEF ] < 40 % , New York Heart Association functional class III ) who underwent peripheral stem cell mobilization with granulocyte-colony stimulating factor ( G-CSF ) .
RESULTS	CD34 ( + ) cells were collected by means of apheresis .
RESULTS	Patients underwent myocardial perfusion imaging , and CD34 ( + ) cells were injected in the coronary artery supplying viable segments with reduced myocardial perfusion and regional dysfunction .
RESULTS	Myocardial perfusion imaging was repeated 6 months later .
RESULTS	Clinical response to stem cell therapy was predefined as a change in LVEF > 5 % .
RESULTS	The majority of patients were men ( 81 % ) with an overall mean age 53 9 years , LVEF 25 5 % , and 6-minute walking distance 354 71 m. Myocardial perfusion defects at rest were observed in 86 % of patients and were more common in the left anterior descending territory ( 50 % ) .
RESULTS	At 6 months ' follow-up , there was a significant improvement in rest myocardial perfusion scores ( 6.3 5.8 vs 3.1 4.3 ; P < .001 ) , LVEF ( 25 7 % vs 29 8 % ; P = .005 ) , and 6-minute walking distance ( 354 71 m vs 404 91 m ; P < .001 ) .
RESULTS	Responders to stem cell therapy had lower summed rest perfusion score at both baseline ( 3.2 3.0 vs 9.1 6.3 ; P = .015 ) and follow-up ( 1.0 1.5 vs 5.0 5.1 ; P = .028 ) .
CONCLUSIONS	CD34 ( + ) cell transplantation may lead to improved myocardial perfusion in patients with nonischemic DCM .
CONCLUSIONS	Patients with less severe myocardial perfusion defects at baseline may have an increased likelihood to respond to intracoronary CD34 ( + ) cell transplantation .

###25301831
BACKGROUND	Appropriate guideline criteria for use of implantable cardioverter-defibrillators ( ICDs ) do not take into account potential recovery of left ventricular ejection fraction ( LVEF ) in patients treated with CRT-defibrillator .
RESULTS	Patients randomized to CRT-defibrillator from the Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy ( MADIT-CRT ) trial who survived and had paired echocardiograms at enrollment and at 12 months ( n = 752 ) were included .
RESULTS	Patients were evaluated by LVEF recovery in 3 groups ( LVEF 35 % [ reference ] , 36 % -50 % , and > 50 % ) on outcomes of ventricular tachyarrhythmias ( VTAs ) , VTA 200 bpm , ICD shock , heart failure or death , and inappropriate ICD therapy by multivariable Cox models .
RESULTS	A total of 7.3 % achieved LVEF normalization ( > 50 % ) .
RESULTS	The average follow-up was 2.20.8 years .
RESULTS	The risk of VTA was reduced in patients with LVEF > 50 % ( hazard ratio [ HR ] , 0.24 ; 95 % confidence interval [ CI ] , 0.07-0 .82 ; P = 0.023 ) and LVEF of 36 % to 50 % ( HR , 0.44 ; 95 % CI , 0.28-0 .68 ; P < 0.001 ) .
RESULTS	Among patients with LVEF > 50 % , only 1 patient had VTA 200 bpm ( HR , 0.16 ; 95 % CI , 0.02-1 .51 ) , none were shocked by the ICD , and 2 died of nonarrhythmic causes .
RESULTS	The risk of HF or death was reduced with improvements in LVEF ( LVEF > 50 % : HR , 0.29 ; 95 % CI , 0.09-0 .97 ; P = 0.045 ; and LVEF of 36 % -50 % : HR , 0.44 ; 95 % CI , 0.28-0 .69 ; P < 0.001 ) .
RESULTS	For inappropriate ICD therapy , no additional risk reduction for LVEF > 50 % was seen compared with an LVEF of 36 % to 50 % .
RESULTS	A total of 6 factors were associated with LVEF normalization , and patients with all factors present ( n = 42 ) did not experience VTAs ( positive predictive value , 100 % ) .
CONCLUSIONS	Patients who achieve LVEF normalization ( > 50 % ) have very low absolute and relative risk of VTAs and a favorable clinical course within 2.2 years of follow-up .
CONCLUSIONS	Risk of inappropriate ICD therapy is still present , and these patients could be considered for downgrade from CRT-defibrillator to CRT-pacemaker at the time of battery depletion if no VTAs have occurred .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00180271 .

###24838369
BACKGROUND	Animal models suggest that neuroactive steroids contribute to alcohol 's acute effects .
BACKGROUND	We previously reported that a common nonsynonymous polymorphism , AKR1C3 2 in the gene encoding the enzyme 3-HSD2 / 17-HSD5 , and a synonymous single nucleotide polymorphism ( SNP ) , rs248793 , in SRD5A1 , which encodes 5-reductase , were associated with alcohol dependence ( AD ) .
OBJECTIVE	The aim of the study was to investigate whether these polymorphisms moderate subjective effects of alcohol in humans and whether AKR1C3 2 affects neuroactive steroid synthesis .
METHODS	Sixty-five Caucasian men ( 34 lighter and 31 heavier drinkers ; mean age 26.2 years ) participated in a double-blind laboratory study where they consumed drinks containing no ethanol or 0.8 g/kg of ethanol .
METHODS	Breath alcohol , heart rate ( HR ) , and self-reported alcohol effects were measured at 40-min intervals , and genotype was examined as a moderator of alcohol 's effects .
METHODS	Levels of the neuroactive steroid 5-androstane-3 ,17 - diol and its precursors , 3,5-androsterone and dihydrotestosterone , were measured at study entry using GC/MS .
RESULTS	Initially , carriers of the AD-protective AKR1C3 2G allele had higher levels of 5-androstane-3 ,17 - diol relative to the precursor 3,5-androsterone than C allele homozygotes .
RESULTS	AKR1C3 2G allele carriers exhibited greater increases in heart rate and stimulant and sedative effects of alcohol than C allele homozygotes .
RESULTS	The genotype effects on sedation were observed only in heavier drinkers .
RESULTS	The only effect of the SRD5A1 SNP was to moderate HR .
RESULTS	There were no interactive effects of the two SNPs .
CONCLUSIONS	The observed effects of variation in a gene encoding a neuroactive steroid biosynthetic enzyme on the rate of 17-reduction of androsterone relative to androstanediol and on alcohol 's sedative effects may help to explain the association of AKR1C3 2 with AD .

###24656138
OBJECTIVE	Hyperhomocysteinemia is associated with arterial stiffness , but underlying pathophysiological mechanisms explaining this association are to be revealed .
OBJECTIVE	This study was aimed to explore two potential pathways concerning the one-carbon metabolism .
OBJECTIVE	A potential causal effect of homocysteine was explored using a genetic risk score reflecting an individual 's risk of having a long-term elevated plasma homocysteine level and also associations with B-vitamin levels were investigated .
RESULTS	Baseline cross-sectional data of the B-PROOF study were used .
RESULTS	In the cardiovascular subgroup ( n = 567 , 56 % male , age 72.65.6 yrs ) pulse wave velocity ( PWV ) was determined using applanation tonometry .
RESULTS	Plasma concentrations of vitamin B12 , folate , methylmalonic acid ( MMA ) and holo transcobalamin ( holoTC ) were assessed and the genetic risk score was based on 13 SNPs being associated with elevated plasma homocysteine .
RESULTS	Associations were examined using multivariable linear regression analysis .
RESULTS	B-vitamin levels were not associated with PWV .
RESULTS	The genetic risk score was also not associated with PWV .
RESULTS	However , the homocysteine-gene interaction was significant ( p < 0.001 ) in the association of the genetic risk score and PWV .
RESULTS	Participants with the lowest genetic risk of having long-term elevated homocysteine levels , but with higher measured homocysteine levels , had the highest PWV levels .
CONCLUSIONS	Homocysteine is unlikely to be causally related to arterial stiffness , because there was no association with genetic variants causing hyperhomocysteinemia , whereas non-genetically determined hyperhomocysteinemia was associated with arterial stiffness .
CONCLUSIONS	Moreover , the association between homocysteine and arterial stiffness was not mediated by B-vitamins .
CONCLUSIONS	Possibly , high plasma homocysteine levels reflect an unidentified factor , that causes increased arterial stiffness .

###25800891
BACKGROUND	Vorinostat is a histone deacetylase inhibitor that changes gene expression and protein activity .
BACKGROUND	On the basis of the clinical benefit reported in patients with malignant pleural mesothelioma treated in a phase 1 study of vorinostat , we designed this phase 3 trial to investigate whether vorinostat given as a second-line or third-line therapy improved patients ' overall survival .
METHODS	This double-blind , randomised , placebo-controlled trial was done in 90 international centres .
METHODS	Patients with measurable advanced malignant pleural mesothelioma and disease progression after one or two previous systemic regimens were eligible .
METHODS	After stratification for Karnofsky performance status , histology , and number of previous chemotherapy regimens , patients were randomly assigned ( 1:1 ) by use of an interactive voice response system with a block size of four to either treatment with vorinostat or placebo .
METHODS	Patients received oral vorinostat 300 mg ( or matching placebo ) twice daily on days 1 , 2 , 3 , 8 , 9 , 10 , 15 , 16 , and 17 of a 21-day cycle .
METHODS	The primary endpoints were overall survival and safety and tolerability of vorinostat .
METHODS	The primary efficacy comparison was done in the intention-to-treat population , and safety and tolerability was assessed in the treated population .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00128102 .
RESULTS	From July 12 , 2005 , to Feb 14 , 2011 , 661 patients were enrolled and randomly assigned to receive either vorinostat ( n = 329 ) or placebo ( n = 332 ) and included in the intention-to-treat analysis .
RESULTS	Median overall survival for vorinostat was 307 weeks ( 95 % CI 267-361 ) versus 271 weeks ( 231-319 ) for placebo ( hazard ratio 098 , 95 % CI 083-117 , p = 086 ) .
RESULTS	The most common grade 3 or worse adverse events for patients treated with vorinostat were fatigue or malaise ( 51 [ 16 % ] patients in the vorinostat group vs 25 [ 8 % ] in the placebo group ] ) and dyspnoea ( 35 [ 11 % ] vs 45 [ 14 % ] ) .
CONCLUSIONS	In this randomised trial , vorinostat given as a second-line or third-line therapy did not improve overall survival and can not be recommended as a therapy for patients with advanced malignant pleural mesothelioma .
BACKGROUND	Merck & Co. .

###24495514
BACKGROUND	Delirium ( or acute confusion ) is a serious illness common in older people , in which a person 's thinking and perceptions may be affected .
BACKGROUND	Reducing delirium is important because of the considerable distress it causes , and the poor outcomes associated with it , such as increased admissions to hospital , falls , mortality and costs to the National Health Service ( NHS ) .
BACKGROUND	Preventing delirium is possible using multicomponent interventions ; successful interventions in hospitals have reduced it by one-third .
BACKGROUND	However , there is little research to guide practice in care homes , where it is common because of the clustering of known risk factors ( older age , frailty , and dementia ) .
BACKGROUND	In previous work we developed a multicomponent intervention to prevent delirium in care homes , called Stop Delirium !
BACKGROUND	The intervention was based upon evidence from the research literature relating to the prevention of delirium and on strategies to change professional practice .
BACKGROUND	Before starting a large costly trial of Stop Delirium !
BACKGROUND	, this pilot study will test and help improve the design and feasibility of the trial protocol .
METHODS	We plan to conduct a cluster randomised pilot trial in 14 care homes ( independent residential and nursing ) .
METHODS	Following recruitment of residents ( over 60 years , consenting or with consultee agreement , able to communicate in English , and not in palliative care ) participating homes will be randomised , stratified by size of home and proportion of residents with dementia .
METHODS	Stop Delirium !
METHODS	will be delivered to intervention homes over 16 months , with controls receiving usual care .
METHODS	The primary outcome measure will be the presence of delirium on any day during a one-month post-intervention period.We will collect data to determine 1 ) recruitment and attrition rates , 2 ) feasibility of various outcomes measurements , and 3 ) feasibility of capturing health resource use ( resident diaries and by examining health records ) .
METHODS	We will estimate the between-cluster variation for the primary outcome , delirium occurrence .
CONCLUSIONS	This pilot study will refine methods for the definitive trial .
CONCLUSIONS	The lessons learnt will also contribute to implementing National Institute for Health and Clinical Excellence ( NICE ) delirium guidelines , which recommend multicomponent interventions for delirium prevention .
BACKGROUND	ISRCTN27972532 .

###24496740
OBJECTIVE	( 1 ) Compare tolerance of aerosolized spray versus syringe administration of topical anesthesia for transnasal flexible laryngoscopy ( TFL ) , ( 2 ) analyze cost-effectiveness of both techniques .
METHODS	Prospective , blinded , randomized trial .
METHODS	Tertiary academic laryngology practice .
METHODS	One hundred and eight patients underwent TFL over 3 months .
METHODS	Patients were randomized to receive equivalent dose 1:1 neosynephrine/4 % plain lidocaine mixture via aerosolized spray ( `` spray '' ) or application with 1-cc syringe ( `` syringe '' ) .
METHODS	Patients and physicians independently rated comfort of TFL on 5-point scale ( 1 = not at all comfortable to 5 = very comfortable ) .
METHODS	Data were collected on patient and endoscopist experience with TFL and reasons for poor tolerance of laryngoscopy .
METHODS	Cost analyses of disposable spray tips and syringes were calculated .
RESULTS	Both patients and physicians reported very high tolerance of TFL .
RESULTS	Patient tolerance appears to be similar between spray - versus syringe-administered anesthesia , although study limitations preclude definitive analysis .
RESULTS	Poor tolerance of laryngoscopy was reported in 6.5 % with comparable distribution between anesthetic delivery methods .
RESULTS	There was no impact of patient prior experience with TFL , and there was no difference between anesthetic methods for TFL performed by resident , fellow , or attending .
RESULTS	The difference between costs of the disposable spray tip versus syringe was $ 1.32 per unit .
CONCLUSIONS	Use of a 1-cc syringe is an effective method to provide topical nasal anesthesia for TFL and saves $ 1.32 per unit compared to disposable spray tips .
CONCLUSIONS	In our practice , transition to syringe-administered nasal anesthesia is projected to save $ 1300 per 1000 patients , or an anticipated $ 1000 per year per physician , with excellent patient tolerance of TFL .

###24841352
BACKGROUND	No randomized trials have so far investigated the cost effectiveness of different methods for implantation and use of central venous ports in oncology patients .
METHODS	Overall , 403 patients eligible for receiving intravenous chemotherapy for solid tumours were randomly assigned to implantation of a single type of port , either through a percutaneous landmark access to the internal jugular vein , an ultrasound ( US ) - guided access to the subclavian vein , or a surgical cut-down access through the cephalic vein at the deltoid-pectoralis groove .
METHODS	Insertion and maintenance costs were estimated by obtaining the charges for an average implant and use , while the costs of the management of complications were analytically assessed .
METHODS	The total cost was defined as the purchase cost plus the insertion cost plus the maintenance cost plus the cost of treatment of the complications , if any .
RESULTS	A total of 401 patients were evaluable-132 with the internal jugular vein , 136 with the subclavian vein and 133 with the cephalic vein access .
RESULTS	No differences were found for the rate of early complications .
RESULTS	The US-guided subclavian insertion site had significantly lower failures .
RESULTS	Infections occurred in 1 , 3 , and 3 patients ( internal jugular , subclavian , and cephalic access , respectively ; p = 0.464 ) , whereas venous thrombosis was observed in 15 , 8 , and 11 patients , respectively ( p = 0.272 ) .
RESULTS	Mean cost for purchase , implantation , diagnosis and treatment of complications in each patient was <euro> 2,167.85 for subclavian US-guided , <euro> 2,335.87 for cephalic , and <euro> 2,384.10 for internal jugular access , respectively ( p = 0.0001 ) .
CONCLUSIONS	US real-time guidance to the subclavian vein resulted in the most cost-effective method of central venous port placement and use .

###24643901
BACKGROUND	This study compares the effect of heliox-driven to that of air-driven bronchodilator therapy on the pulmonary function test ( PFT ) in patients with different levels of asthma severity .
METHODS	One-hundred thirty-two participants were included in the study .
METHODS	Participants underwent spirometry twice with bronchodilator testing on two consecutive days .
METHODS	Air-driven nebulization was used one day and heliox-driven nebulization the other day in random order crossover design .
METHODS	After a baseline PFT , each participant received 2.5 mg of albuterol sulfate nebulized with the randomized driving gas .
METHODS	Post bronchodilator PFT was repeated after 30 min .
METHODS	The next day , the exact same protocol was repeated , except that the other driving gas was used to nebulize the drug .
METHODS	Participants were subgrouped and analyzed according to their baseline FEV ( 1 ) on day 1 : Group I , FEV ( 1 ) 80 % ; Group II , 80 % > FEV ( 1 ) > 50 % ; Group III , FEV ( 1 ) 50 % .
METHODS	The proportion of participants with greater than 12 % and 200-mL increases from their baseline FEV ( 1 ) and the changes from baseline in PFT variables were compared between heliox-driven versus air-driven bronchodilation therapy .
RESULTS	The proportion of participants with > 12 % and 200-mL increases from their baseline FEV ( 1 ) with air - or heliox-driven bronchodilation was not different with respect to the proportion of participants with baseline FEV ( 1 ) 80 % ( 20 vs. 18 % , respectively ) and 80 % > FEV ( 1 ) > 50 % ( 36 vs. 43 % , respectively ) , but it was significantly greater with heliox-driven bronchodilation in participants with FEV ( 1 ) 50 % ( 43 vs. 73 % , respectively ; p = 0.01 ) .
RESULTS	Changes from baseline FVC , FEV ( 1 ) , FEV ( 1 ) / FVC , FEF ( 25-75 ) % , FEF ( max ) , FEF ( 25 ) % , FEF ( 50 ) % , and FEF ( 75 ) % were significantly larger with heliox-driven versus air-driven bronchodilation in participants with baseline FEV ( 1 ) 50 % .
CONCLUSIONS	Improvements in PFT variables are more frequent and profound with heliox-driven compared to air-driven bronchodilator therapy only in asthmatic patients with baseline FEV ( 1 ) 50 % .

###24852424
BACKGROUND	A nasally applied cellulose powder is increasingly used in many countries as a remedy for allergic rhinitis .
BACKGROUND	In 2009 , a 4-week study in birch pollen-allergic children showed a reduction in nasal symptoms .
BACKGROUND	The best effect occurred on days with lower pollen counts .
BACKGROUND	The present study in grass pollen-allergic adults used the same basic design .
METHODS	In May 2013 , a double-blind , placebo-controlled study was conducted in 108 patients with allergic rhinitis due to grass pollen ( 18-40 years of age ) .
METHODS	SMS on mobile phones were used as reminders of treatment and reporting of symptom scores .
RESULTS	We found significant reductions in severity scores for sneezing , runny nose , stuffy nose and symptoms from eyes and lower airways , both separately and together ( all p < 0.001 ) .
RESULTS	Reflective opinion of effect and guess on treatment at follow-up visits ( both p < 0.001 ) confirmed a high efficacy .
RESULTS	No clinically significant adverse effects were reported .
CONCLUSIONS	The product provided significant protection against all seasonal allergic rhinitis symptoms from both upper and lower airways during the grass pollen season in an adult population .
CONCLUSIONS	The magnitude and scope of efficacy support the use of the product as an early choice in the treatment of allergic rhinitis .

###24989920
OBJECTIVE	To evaluate the value of angiography in clarifying the origin of the feeding arteries of primary retroperitoneal tumors and to explore the application of embolization therapy in the treating of primary retroperitoneal tumor .
METHODS	68 patients with primary retroperitoneal tumor were randomized into conventional tumor resection group ( n = 35 ) and the preoperative embolization group ( n = 33 ) .
METHODS	Some clinical data were compared between the preoperative embolization group and the routine operation group , including blood loss , blood transfusion , operation time and adverse reactions after embolization .
METHODS	All the diagnoses were pathologically confirmed .
METHODS	The origins of the tumor-feeding arteries were analyzed .
METHODS	The clinical value of embolization in assisting the surgery as well as in making prognosis was assessed .
RESULTS	According to their location and size , primary retroperitoneal tumors had feeding arteries from different origins .
RESULTS	In this series of cases the tumor blood supply originated from the lumbar artery ( 81.8 % ) , internal iliac artery ( 45.5 % ) and adrenal artery ( 27.3 % ) .
RESULTS	In the preoperative embolization group and conventional surgery group , the blood loss was 912 ml vs. 2 500 ml ( P < 0.001 ) , the blood transfusion was 1 000 ml vs. 2 600 ml ( P < 0.001 ) , the operation time was 4.1 h vs. 5.9 h ( P < 0.001 ) , and the length of hospital stay was 12.5 d vs. 19.8 d ( P < 0.001 ) .
CONCLUSIONS	The origins of the feeding arteries in primary retroperitoneal tumors are very complex .
CONCLUSIONS	Preoperative embolization therapy may effectively reduce the intraoperative blood loss , postoperative adverse events , length of hospital stay , and facilitate the patients ' recovery .

###25285974
OBJECTIVE	To study potential exposures to crystalline silica and the number of work-related cases of silicosis occurring in Alberta .
METHODS	Exposure data comprising 343 occupational samples were collected at 40 worksites across 13 industries .
METHODS	To assess silicosis reporting , cases reported to the Alberta government , claims accepted by the Workers ' Compensation Board for work-related silicosis , and billings to Alberta Health for medical services with a diagnostic code for silicosis during a similar time period were compared .
RESULTS	Workers potentially over-exposed to airborne respirable crystalline silica were identified at most of the worksites evaluated .
RESULTS	There were large discrepancies in the number of silicosis cases found .
CONCLUSIONS	Many Alberta workers may be over-exposed to airborne respirable crystalline silica , and the incidence of work-related silicosis in Alberta may not be adequately represented by the official statistics .

###24307656
BACKGROUND	Despite the use of embolic protection devices , no-reflow can still occur during saphenous vein grafts ( SVGs ) intervention .
BACKGROUND	High-dose intracoronary adenosine infusion preconditions the myocardium , improves coronary flow , and prevents no-reflow .
BACKGROUND	The role of high-dose intragraft adenosine infusion on protection of microvascular function and prevention of no-reflow has not been investigated
OBJECTIVE	We investigated the cardioprotective effect of high-dose intragraft adenosine infusion , compared with placebo , on microvascular function and prevention of no-reflow during SVGs intervention .
METHODS	We randomized 22 patients with SVGs stenoses to receive either a 10-min intragraft adenosine infusion ( 200 g/min ; total dose = 2,000 g ) or normal saline prior to stenting .
METHODS	Average peak velocity ( APV ) , coronary flow velocity reserve ( CVR ) , thrombolysis in myocardial infarction ( TIMI ) frame count ( TFC ) , TIMI myocardial perfusion grade ( TMPG ) , and the rate of no-reflow were compared between the two groups before adenosine or saline infusions and after stenting
RESULTS	After stenting , hyperemic APV , CVR , and TMPG were significantly higher in the adenosine-treated group than in the control group ( 60 18 vs. 35 10 cm/sec ; 2.6 0.54 vs. 1.8 0.47 ; and 2.8 0.90 vs. 2.1 0.80 , respectively ; P < 0.05 .
RESULTS	TFC was significantly lower in the adenosine-treated group than in the control group ( 14 3.0 vs. 26 13 ; P < 0.05 ) .
RESULTS	In the control group , four patients ( 36 % ) developed no-reflow compared to none in the adenosine-treated patient ; P < 0.05 CONCLUSIONS : This study provides the first evidence that high-dose intragraft adenosine infusion compared with placebo protects microvascular function and prevents no-reflow during SVGs intervention .

###25146716
BACKGROUND	Among surgical oncology patients , incisional surgical site infection is associated with substantially increased morbidity , mortality and healthcare costs .
BACKGROUND	Moreover , while adults undergoing pancreaticoduodenectomy with preoperative placement of an intrabiliary stent have a high risk of this type of infection , and wound protectors may significantly reduce its risk , no relevant studies of wound protectors yet exist involving this patient population .
BACKGROUND	This study will evaluate the efficacy of a dual-ring wound protector for prevention of incisional surgical site infection among adults undergoing pancreaticoduodenectomy with preoperatively-placed intrabiliary stents .
METHODS	This study will be a parallel , dual-arm , randomised controlled trial that will utilise a more explanatory than pragmatic attitude .
METHODS	All adults ( 18years ) undergoing a pancreaticoduodenectomy at the Foothills Medical Centre in Calgary , Alberta , Canada with preoperative placement of an intrabiliary stent will be considered eligible .
METHODS	Exclusion criteria will include patient age < 18years and those receiving long-term glucocorticoids .
METHODS	The trial will employ block randomisation to allocate patients to a commercial dual-ring wound protector ( the Alexis Wound Protector ) or no wound protector and the current standard of care .
METHODS	The main outcome measure will be the rate of surgical site infection as defined by the Centers for Disease Control and Prevention criteria within 30days of the index operation date as determined by a research assistant blinded to treatment allocation .
METHODS	Outcomes will be analysed by a statistician blinded to allocation status by calculating risk ratios and 95 % CIs and compared using Fisher 's exact test .
BACKGROUND	This will be the first randomised trial to evaluate the efficacy of a dual-ring wound protector for prevention of incisional surgical site infection among patients undergoing pancreaticoduodenectomy .
BACKGROUND	Results of this study are expected to be available in 2016/2017 and will be disseminated using an integrated and end-of-grant knowledge translation strategy .
BACKGROUND	ClinicalTrials.gov identifier NCT01836237 .

###24385633
OBJECTIVE	Examine the relationship of demographics and health conditions , alone and in combination , on objective measures of cognitive function in a large sample of community-dwelling older adults .
METHODS	Baseline data from 2,782 participants in the Advanced Cognitive Training in Independent and Vital Elderly ( ACTIVE ) study were used to examine relationships of demographics and health conditions with composite scores of memory , reasoning , and speed of processing .
RESULTS	Younger age , increased education , and White race were independently associated with better performance in each cognitive domain after adjusting for gender and health conditions .
RESULTS	Male gender , diabetes , and suspected clinical depression were associated with poorer cognitive functioning ; suspected clinical depression was associated with lower reasoning and diabetes and history of stroke with slower speed of processing .
CONCLUSIONS	Age , education , and race are consistently associated with cognitive performance in this sample of older community-dwelling adults .
CONCLUSIONS	Diabetes , stroke , and suspected clinical depression had independent but weaker effects on cognition .

###25351765
BACKGROUND	Functional constipation ( FC ) is a common functional gastrointestinal disorders ( FGIDs ) which has a major impact on the quality of life .
BACKGROUND	Acupuncture is widely used as an alternative and complementary medicine ( CAM ) for FC , but the available evidence of its effectiveness is scarce .
BACKGROUND	Therefore , we will perform a randomized controlled trial to determine whether acupuncture improves symptom and quality of life in FC patients more effectively than sham acupuncture or gastrointestinal prokinetic agent .
BACKGROUND	This article will report the protocol of the trial .
METHODS	The current trial is a multicenter , randomized , three-arm controlled study undergoing in China .
METHODS	About 243 people who aged from 18 to 65years with FC will be recruited in this study .
METHODS	These participants will be randomly allocated into three treatment groups , including electro-acupuncture ( EA ) , Mosapride ( M ) and Mosapride & Sham Electro-acupuncture ( MS ) groups in a 1:1:1 ratio .
METHODS	Both the EA and sham EA receives 16 sessions of needling at Quchi ( LI11 ) and Shangjuxu ( ST37 ) during 4weeks of treatment , and a follow-up period of 4weeks .
METHODS	These groups will be compared on the primary outcomes of the number of times of defecation at baseline and 2 , 4 , 8weeks after randomization .
METHODS	The secondary outcome measures include : stool consistency , intensity of defecating difficulty , MOS item Short Form health survey ( SF-36 ) , Self-Rating Anxiety Scale ( SAS ) , Self-rating Depression Scale ( SDS ) , and the validated Patient Assessment of Constipation Quality of Life ( PAC-QOL ) .
METHODS	These outcomes are measured at baseline and 2 , 4weeks after randomization , but SF-36 is measured at baseline and 4weeks after randomization .
CONCLUSIONS	This study will supply significant evidence for using acupuncture to treat FC , and will help us to observe whether it is a therapeutic effect rather than a placebo effect .

###25986492
OBJECTIVE	The Intercollegiate Surgical Curriculum now recommends that cardiac surgical trainees should be able to understand and interpret transesophageal echocardiography images .
OBJECTIVE	However , cardiac surgical trainees receive limited formal transesophageal echocardiography training .
OBJECTIVE	The objective of this study was to assess the impact of simulation-based teaching versus more traditional operating room teaching on transesophageal echocardiography knowledge in cardiac surgical trainees .
METHODS	A total of 25 cardiac surgical trainees with no formal transesophageal echocardiography learning experience were randomly assigned by computer to a study group receiving simulation-based transesophageal echocardiography teaching via the Heartworks ( Inventive Medical , London , UK ) simulator ( n = 12 ) or a control group receiving transesophageal echocardiography teaching during elective cardiac surgery ( n = 13 ) .
METHODS	Each subject undertook a video-based test composed of 20 multiple choice questions on standard transesophageal echocardiography views before and after teaching .
RESULTS	There was no significant difference in the pretest scores between the 2 groups ( P = .89 ) .
RESULTS	After transesophageal echocardiography teaching , subjects within each group demonstrated a statistically significant improvement in transesophageal echocardiography knowledge .
RESULTS	Although the subjects within the simulation group outperformed their counterparts in the operating room teaching group in the post-test scores , this difference was not significant ( P = .14 ) .
CONCLUSIONS	Despite the familiarity with transesophageal echocardiography images during surgery , subjects in the simulation group performed at least as well as those in the operating room group .
CONCLUSIONS	Surgical trainees will benefit from formal transesophageal echocardiography teaching incorporated into their training via either learning method .

###25577501
OBJECTIVE	The purpose of this study is to explore the applicability of a psychosocial intervention in childhood cancer patients .
METHODS	This individualized structured psychosocial program to enhance social-emotional functioning and coping with disease-related effects includes six sessions for children and two sessions for parents .
METHODS	This program was part of a combined intervention with physical exercise .
METHODS	Questionnaires are used to evaluate completion of the psychosocial intervention , coping and satisfaction with the psychosocial intervention by patients and psychologists , and ranking of the individual topics by patients , parents , and psychologists .
RESULTS	Of the 30 patients ( mean age 13.0 ( SD 3.0 ) ; 53.3 % male ; 30 % still on treatment ) who participated in the psychosocial intervention , two dropped out due to medical complications and one due to lack of time ; 90 % completed the psychosocial intervention .
RESULTS	Overall , patients liked participation in the intervention ( 4.2 on a 5-point scale ; SD 0.8 ) and were positive about the psychologists ( 8.1 on a 10-point scale ; SD 1.3 ) .
RESULTS	Psychologists rated the intervention on several points ( e.g. , clarity of the manual and content of the intervention ) , and mean scores ranged from 7.1 ( SD 1.1 ) to 8.6 ( SD 0.9 ) on 10-point scales .
RESULTS	Minor adaptations were suggested by patients and psychologists , including customizing according to age and a more patient-tailored approach .
CONCLUSIONS	This psychosocial intervention for childhood cancer patients appears to be applicable .
CONCLUSIONS	Future studies need to establish whether this intervention combined with a physical exercise intervention actually improves psychosocial functioning of childhood cancer patients .
CONCLUSIONS	When proven effective , this combined intervention can be offered to childhood cancer patients and may enhance their physical health and quality of life .

###24555604
OBJECTIVE	The objective of our study was to evaluate image quality and overall adequacy of low-dose CT angiography ( CTA ) with model-based iterative reconstruction ( MBIR ) in patients who had undergone endovascular aneurysm repair ( EVAR ) of a thoracic or abdominal aortic aneurysm .
METHODS	Thirty patients , all of whom had undergone standard-dose CTA performed previously with adaptive statistical iterative reconstruction ( ASIR ) , underwent low-dose CTA for surveillance after EVAR .
METHODS	Two radiologists randomly evaluated both studies , and quality parameters were assessed .
METHODS	The maximal aneurysm diameter was measured , and the images were evaluated to see whether an endoleak was present .
METHODS	The image noise and contrast-to-noise ratio ( CNR ) were measured .
METHODS	The volume CT dose index and dose-length product were recorded .
RESULTS	The mean image score for low-dose CTA was acceptable to very good in all categories of assessment .
RESULTS	There was no significant difference between low-dose CTA and standard-dose CTA in the evaluation of the stent lumen .
RESULTS	Subjective assessments of stent configuration , aneurysm outline , aortic branch vessel outline , overall adequacy of vascular imaging , and overall adequacy of solid organ imaging were superior on standard-dose CTA .
RESULTS	Interobserver agreement for endoleak detection was higher for low-dose CTA .
RESULTS	There was no significant difference in the mean aneurysm diameter between the two readers on low-dose CTA and standard-dose CTA .
RESULTS	The effective radiation dose for low-dose CTA was lower than standard-dose CTA during both the arterial ( mean , 4.4 vs 16.2 mSv , respectively ) and the delayed ( 2.4 vs 6.7 mSv ) phase acquisitions .
RESULTS	The measured image noise was lower ( 14.7 vs 19.3 HU ) and CNR was higher ( 25.6 vs 17.1 ) on the low-dose CTA studies than on the standard-dose CTA studies .
CONCLUSIONS	Low-dose CTA with MBIR enables up to 73 % dose reduction as compared with CTA performed with ASIR while maintaining diagnostic adequacy for CTA surveillance of patients who have undergone EVAR of a thoracic or abdominal aortic aneurysm .

###24919526
OBJECTIVE	To assess the long-term glycaemic durability , safety and tolerability of dapagliflozin versus glipizide as add-on therapies in patients with type 2 diabetes inadequately controlled by metformin alone .
METHODS	This was a 52-week , randomised , double-blind study of dapagliflozin ( n = 406 ) versus glipizide ( n = 408 ) , uptitrated over 18 weeks according to tolerability and glycaemic response to a maximum of 10 and 20 mg/day , respectively , as add-on therapies to metformin ( 1500 mg/day ) with a 156-week double-blind extension period .
METHODS	Data over 104 weeks are reported here .
RESULTS	In total , 53.1 % of patients completed 104 weeks of treatment .
RESULTS	After the greater initial decrease ( 0-18 weeks ) in glycated haemoglobin ( HbA1c ) with glipizide , the 18-104-week HbA1c coefficient of failure ( CoF ) was lower with dapagliflozin ( 0.13 % / year ) than with glipizide ( 0.59 % / year ) , resulting in significant dapagliflozin versus glipizide differences of -0.46 % / year ( 95 % CI -0.60 , -0.33 ; p = 0.0001 ) for CoF and -0.18 % ( -2.0 mmol/mol ) [ 95 % CI -0.33 ( -3.6 ) , -0.03 ( -0.3 ) ; p = 0.021 ] for 104-week HbA1c .
RESULTS	Dapagliflozin produced sustained reductions in weight and systolic blood pressure , whereas glipizide increased weight and systolic blood pressure , giving 104-week dapagliflozin versus glipizide differences of -5.1 kg ( 95 % CI : -5.7 , -4.4 ) and -3.9 mmHg ( 95 % CI : -6.1 , -1.7 ) , respectively .
RESULTS	Over 104 weeks , the hypoglycaemia rate was 10-fold lower with dapagliflozin than with glipizide ( 4.2 vs. 45.8 % ) , whereas patient proportions with events suggestive of genital infection and of urinary tract infection ( UTI ) were greater with dapagliflozin ( 14.8 and 13.5 % , respectively ) than with glipizide ( 2.9 and 9.1 % , respectively ) .
CONCLUSIONS	Over 2 years , compared with glipizide , dapagliflozin demonstrated greater glycaemic durability , sustained reductions in weight and systolic blood pressure and a low hypoglycaemia rate ; however , genital infections and UTIs occurred more frequently .

###25142708
BACKGROUND	Nitrous oxide is commonly used in general anaesthesia but concerns exist that it might increase perioperative cardiovascular risk .
BACKGROUND	We aimed to gather evidence to establish whether nitrous oxide affects perioperative cardiovascular risk .
METHODS	We did an international , randomised , assessor-blinded trial in patients aged at least 45 years with known or suspected coronary artery disease having major non-cardiac surgery .
METHODS	Patients were randomly assigned via automated telephone service , stratified by site , to receive a general anaesthetic with or without nitrous oxide .
METHODS	Attending anaesthetists were aware of patients ' group assignments , but patients and assessors were not .
METHODS	The primary outcome measure was a composite of death and cardiovascular complications ( non-fatal myocardial infarction , stroke , pulmonary embolism , or cardiac arrest ) within 30 days of surgery .
METHODS	Our modified intention-to-treat population included all patients randomly assigned to groups and undergoing induction of general anaesthesia for surgery .
METHODS	This trial is registered at ClinicalTrials.gov , number NCT00430989 .
RESULTS	Of 10,102 eligible patients , we enrolled 7112 patients between May 30 , 2008 , and Sept 28 , 2013.3543 were assigned to receive nitrous oxide and 3569 were assigned not to receive nitrous oxide .
RESULTS	3483 patients receiving nitrous oxide and 3509 not receiving nitrous oxide were assessed for the primary outcome .
RESULTS	The primary outcome occurred in 283 ( 8 % ) patients receiving nitrous oxide and in 296 ( 8 % ) patients not receiving nitrous oxide ( relative risk 096 , 95 % CI 083112 ; p = 064 ) .
RESULTS	Surgical site infection occurred in 321 ( 9 % ) patients assigned to nitrous oxide , and in 311 ( 9 % ) patients in the no-nitrous oxide group ( p = 061 ) , and severe nausea and vomiting occurred in 506 patients ( 15 % ) assigned to nitrous oxide and 378 patients ( 11 % ) not assigned to nitrous oxide ( p < 00001 ) .
CONCLUSIONS	Our findings support the safety profile of nitrous oxide use in major non-cardiac surgery .
CONCLUSIONS	Nitrous oxide did not increase the risk of death and cardiovascular complications or surgical-site infection , the emetogenic effect of nitrous oxide can be controlled with antiemetic prophylaxis , and a desired effect of reduced volatile agent use was shown .
BACKGROUND	Australian National Health and Medical Research Council ; Australian and New Zealand College of Anaesthetists ; Heart and Stroke Foundation of Quebec , Heart and Stroke Foundation of Ontario , Canada ; General Research Fund of the Research Grant Council , Hong Kong Special Administrative Region , China .

###24257266
OBJECTIVE	Weight reduction programs are not generally designed or adapted for people with physical disabilities .
OBJECTIVE	This study examined the effect of a 9-months remote , telephone-based weight management program for people with physical disabilities using a Web-based system ( Personalized Online Weight and Exercise Response System [ POWERS ] ) .
METHODS	A total of 102 participants ( mean SD age , 46.5 12.7 yrs ; body mass index , 32.0 5.8 kg/m ( 2 ) ) with a physical disability ( spinal cord injury , multiple sclerosis , spina bifida , cerebral palsy , stroke , or lupus ) were randomized to one of three conditions : physical activity only ( POWERS ) , physical activity plus nutrition ( POWERS ( plus ) ) , and control .
METHODS	The POWERS group received a physical activity tool kit and regular coaching telephone calls .
METHODS	The POWERS ( plus ) group received an intervention identical to that of the POWERS group plus nutritional information .
METHODS	The control group received the physical activity tool kit and self-guided health promotion resources at the completion of the trial but no coaching .
RESULTS	Postintervention differences in body weight were found between the groups .
RESULTS	There was a significant group time interaction ( P < 0.01 ) in postintervention body weight , with both the POWERS and POWERS ( plus ) groups demonstrating greater reduction in body weight compared with the control group ( POWERS : -2.1 5.5 kg , -2.4 -5.9 % ; POWERS ( plus ) : -0.5 5.0 kg , -0.6 4.3 % ; control : +2.6 5.3 kg , 3.1 7.4 % ) .
CONCLUSIONS	A low-cost telephone intervention supported with a Web-based remote coaching tool ( POWERS ) can be an effective strategy for assisting overweight adults with physical disabilities in maintaining or reducing their body weight .

###24800828
BACKGROUND	During the development of a vaccine , identification of the correlates of protection is of paramount importance for establishing an objective criterion for the protective performance of the vaccine .
BACKGROUND	However , the ascertainment of correlates of immunity conferred by any vaccine is a difficult task .
METHODS	While conducting a phase three double-blind , cluster-randomized , placebo-controlled trial of a bivalent killed whole-cell oral cholera vaccine in Kolkata , we evaluated the immunogenicity of the vaccine in a subset of participants .
METHODS	Randomly chosen participants ( recipients of vaccine or placebo ) were invited to provide blood samples at baseline , 14 days after the second dose and one year after the first dose .
METHODS	At these time points , serum geometric mean titers ( GMT ) of vibriocidal antibodies and seroconversion rates for vaccine and placebo arms were calculated and compared across the age strata ( 1 to 5 years , 5 to 15 years and more than 15 years ) as well as for all age groups .
RESULTS	Out of 137 subjects included in analysis , 69 were vaccinees and 68 received placebo .
RESULTS	There were 57 and 58 geometric mean fold ( GMF ) rises in titers to Vibrio cholerae Inaba and Ogawa , respectively at 14 days after the second dose , with 57 % and 61 % of vaccinees showing a four-fold or greater titer rise , respectively .
RESULTS	After one year , the titers to Inaba and Ogawa remained 17 and 28 fold higher , respectively , compared to baseline .
RESULTS	Serum vibriocidal antibody response to V. cholerae O139 was much lower than that to Inaba or Ogawa .
RESULTS	No significant differences in the GMF-rises were observed among the age groups .
CONCLUSIONS	The reformulated oral cholera vaccine induced a statistically significant anti-O1 Inaba and O1 Ogawa vibriocidal antibody response 14 days after vaccination , which although declined after one year remained significantly higher than baseline .
CONCLUSIONS	Despite this decline , the vaccine remained protective five years after vaccination .

###25045824
BACKGROUND	GS-4774 is a recombinant , heat-killed , yeast-based immunotherapy engineered to express hepatitis B virus ( HBV ) - specific antigens .
BACKGROUND	GS-4774 is being developed as a therapeutic vaccine for chronic HBV infection .
BACKGROUND	The aim of this study was to assess the safety , tolerability and immunogenicity of GS-4774 in healthy subjects .
METHODS	This was a randomized , open-label , dose-ascending study .
METHODS	Subjects were allocated to one of three dose groups ( n = 20 per group ) to receive 10 , 40 or 80 yeast units ( YU ; 1YU = 10 ( 7 ) yeast ) of GS-4774 in two immunization regimens ( five subcutaneous injections at weekly intervals with one monthly booster or three subcutaneous injections at monthly intervals ) .
METHODS	T-cell-mediated responses were determined by interferon ( IFN ) - enzyme-linked immunospot ( ELISpot ) assay and lymphocyte-proliferation assay ( LPA ) .
RESULTS	Adverse events were reported by 39 of 60 ( 65 % ) subjects ; all were mild or moderate and none was serious .
RESULTS	Adverse events occurred most frequently in the highest dose group , 80YU , and the number of individual events was higher after weekly immunization than monthly .
RESULTS	The most common adverse events were injection-site reactions .
RESULTS	Most ( 88 % ) subjects responded to GS-4774 by at least one of the T-cell assays .
RESULTS	Following immunization with GS-4774 , IFN -- producing T-cells specific for HBV antigens were detectable in 30 ( 51 % ) subjects .
RESULTS	The ELISpot response was observed at all doses , with the highest frequency of responders occurring at the highest dose ( 10YU : 45 % ; 40YU : 35 % ; 80YU : 74 % ) .
RESULTS	Proliferative responses to HBV recombinant antigens were observed in 90 % subjects ; responses were mainly independent of GS-4774 dose and immunization regimen .
CONCLUSIONS	GS-4774 was safe and well-tolerated in healthy subjects with injection-site reactions being the most frequently reported adverse events .
CONCLUSIONS	With both weekly and monthly regimens , GS-4774 provided HBV-specific immune responses at all doses evaluated .
CONCLUSIONS	Further evaluation of GS-4774 is ongoing in patients with chronic HBV infection .
BACKGROUND	Clinicaltrials.gov ( NCT01779505 ) .

###25137874
BACKGROUND	Insulin resistance is commonly observed in uremic patients .
BACKGROUND	Angiotensin II receptor blockers ( ARB ) are reported to act as insulin sensitizers in the animal model of hypertension and hypertensive patients .
BACKGROUND	The authors investigated the effects of valsartan on insulin resistance and glucose metabolism in patients with long-term hemodialysis in the prospective , randomized controlled study .
METHODS	Thirty-three hemodialysis patients were randomized into two treatment groups , valsartan 80 to 320 mg/day ( n = 18 ) or non-renin-angiotensin-aldosterone-system blocking antihypertensive agents ( control , n = 15 ) , treated for 12 weeks .
METHODS	Insulin resistance determined by homeostasis model assessment ( HOMA-IR ) , fasting plasma glucose ( FPG ) , fasting plasma insulin , and blood pressure monitoring were measured during the study .
RESULTS	At baseline , metabolic profiles did not significantly differ between the treatment and the control groups .
RESULTS	After 12 weeks of treatment , the valsartan group significantly improved HOMA-IR from 2.6 + / - 0.9 to 2.3 + / - 0.7 ( p = 0.041 ) and significantly decreased FPG from 90.1 + / - 15.1 to 84.8 + / - 13.2 mg/dL ( p = 0.008 ) .
RESULTS	In contrast , the control group was not associated with any significant changes in HOMA-IR , FPG , and fasting insulin levels .
RESULTS	At the end of 12-week treatment , HOMA-IR , FPG , and fasting insulin levels were not significantly different between the two groups .
CONCLUSIONS	These results indicate that the antihypertensive action of valsartan improves glucose metabolism by improving the peripheral insulin sensitivity in subjects with long-term dialysis .

###25131042
BACKGROUND	Recently there has been great concern about the quality of life and health of liver transplant patients ( LTP ) .
BACKGROUND	These patients often present with metabolic disorders , which can improve with regular physical exercise .
BACKGROUND	The aim of this study was to investigate the effect of a physical exercise program on the functional capacity of LTP .
METHODS	The distance walked in the 6-minute walk test and the resting energy expenditure ( REE ) were evaluated in 15 subjects who regularly attend the outpatient Bias Fortes Clinic at Universidade Federal de Minas Gerais .
METHODS	The patients were divided into 2 groups , the Exercise Group ( EG ) ( 6 men and 3 women ; 52 15 years old , BMI 22.4 4.0 kg/m ) performed 24 sessions of continuous 30min treadmill exercise .
METHODS	Intensity of exercise was increased from 50 % -70 % of the maximum heart rate over the training period .
METHODS	A group of 3 men and 3 women ( 39 15 years , BMI 24.5 4.4 kg/m ) served as controls ( CG ) .
RESULTS	After undergoing exercise training , patients in the EG showed a 19.4 % increase in the distance walked ( pre = 453.6 128.0 m and post = 582.5 90.1 m ) .
RESULTS	Also , there was an increase in their REE ( pre = 1,060.0 194.2 kcal and post = 1,375.0 258.6 kcal ) ( P < .05 ) indicating an increase in their exercise capacity and metabolic improvements .
RESULTS	There were no differences in the distance walked ( pre = 516.5 62.0 m and post = 517.7 71.9 m ) and REE ( pre = 1,393.0 213.3 kcal to post = 1,465.0 170.3 kcal ) ( P > .05 ) for CG .
RESULTS	Our results are in agreement with previous studies .
CONCLUSIONS	We conclude that the exercise program promoted significant improvements in functional capacity .
CONCLUSIONS	These findings have positive implications for the control of metabolic diseases , which are common in patients after liver transplantation .

###24597289
OBJECTIVE	To evaluate the effects of combined administration of gonadotropin-releasing hormone ( GnRH ) agonist with human chorionic gonadotropin ( hCG ) for final oocyte maturation in GnRH antagonist cycles for in vitro fertilization ( IVF ) .
METHODS	A total of 120 infertile women undergoing GnRH antagonist multiple-dose protocol for controlled ovarian stimulation were recruited and randomized into 2 groups : a study group ( n = 60 ) and a control group ( n = 60 ) .
METHODS	For the study group , both GnRH agonist and recombinant hCG ( rhCG ) were injected concomitantly for final oocyte maturation when 1 or more follicles reached a mean diameter of 18 mm .
METHODS	For the control group , rhCG alone was administered for final oocyte maturation .
RESULTS	There were no significant differences in patient characteristics .
RESULTS	The 2 groups were also similar with respect to the number of oocytes retrieved , fertilized oocytes and good-quality embryos .
RESULTS	Embryo implantation rate ( 24.7 % vs. 14.9 % ) , clinical pregnancy rate per cycle ( 53.3 % vs. 33.3 % ) , and live birth rate ( 50.0 % vs. 30.0 % ) were significantly higher in the study group than in the control group ( p = 0.006 , p = 0.027 , and p = 0.025 , respectively ) .
CONCLUSIONS	Combined administration of GnRH agonist with rhCG may be beneficial in improving endometrial receptivity and pregnancy rate in GnRH antagonist cycles for IVF .

###25304863
BACKGROUND	Stress affects flow-experience , but the mediating psychobiological mechanisms remain unknown .
BACKGROUND	Previous studies showed an association between flow-experience and endogenous cortisol levels , suggesting an inverted , u-shaped relation between flow-experience and cortisol .
BACKGROUND	However , these studies could not exclude effects of other stress factors .
OBJECTIVE	The aim of this experiment was , therefore , to test the isolated effect of cortisol on flow-experience , independent of concomitant physiological and psychological stress responses , via controlled administration of exogenous cortisol .
METHODS	Sixty-four young healthy subjects ( 32 males , 32 females ) participated in the experiment .
METHODS	According to a double-blind , randomized , placebo-controlled , cross-over design , they received 20 mg oral cortisol on 1 day and placebo on the other day , respectively , with a time distance of 1 week between the experimental days .
METHODS	One hour after cortisol administration , participants engaged in the computer game Pacman .
METHODS	Pacman was delivered in five blocks of randomly differing difficulty levels .
METHODS	One block lasted 5 min .
METHODS	At the end of each block , participants rated flow-experience by the Flow Short Scale .
METHODS	Data was analyzed with hierarchical linear modeling .
METHODS	Subjects were not able to predict whether the pill they received contained cortisol or placebo .
RESULTS	Overall , results revealed a negative effect of oral 20 mg cortisol on flow-experience , with no differences between males and females .
CONCLUSIONS	This study is the first to show that exogenous cortisol in a dose corresponding to a severe stressor impairs flow-experience .
CONCLUSIONS	The observed negative effect of high cortisol dosage on experienced flow underlines recent findings of an inverted u-shaped relationship between cortisol and flow .

###24347426
BACKGROUND	GH action is attenuated by estrogens and selective estrogen receptor modulators ( SERMs ) administered orally .
BACKGROUND	During GH therapy in hypopituitary women , co-treatment with raloxifene , a SERM , induced a smaller gain in lean body mass ( LBM ) compared with estrogen , despite an equal reduction in IGF1 .
BACKGROUND	As a higher IGF-binding protein-3 ( IGFBP3 ) level was observed with raloxifene co-treatment , we hypothesize that an increase in IGFBP3 reduced IGF1 bioactivity causing the attenuated anabolic effect .
OBJECTIVE	To assess the effects of 17-estradiol ( E ) and raloxifene on bioactive IGF1 .
METHODS	In study 1 , 12 GH-deficient ( GHD ) women were randomized to raloxifene 120 mg/day or E 4 mg/day for 1 month .
METHODS	In study 2 , 16 GHD women were randomized to 1 month GH treatment alone ( 0.5 mg/day ) and in combination with raloxifene ( 60 mg/day ) or E ( 2 mg/day ) .
METHODS	We measured bioactive IGF1 , immunoreactive IGF1 and IGF2 , and IGFBP3 immunoreactivity and fragmentation .
RESULTS	Raloxifene and estrogen suppressed ( P < 0.05 ) total IGF1 equally in GHD and GH-replaced hypopituitary women .
RESULTS	In GHD patients , neither raloxifene nor estrogen affected bioactive IGF1 .
RESULTS	GH significantly increased IGF1 bioactivity , an effect attenuated by co-treatment with raloxifene ( -23 7 % , P < 0.01 ) and estrogen ( -26 3 % , P = 0.06 ) .
RESULTS	Total IGF1 correlated ( r ( 2 ) = 0.54 , P < 0.001 ) with bioactive IGF1 , which represented 3.1 0.2 % of the total IGF1 , irrespective of the treatments .
RESULTS	Total IGF2 was unchanged by raloxifene and estrogen treatment .
RESULTS	IGFBP3 was significantly higher during raloxifene administration , whereas no differences in IGFBP3 fragmentation were observed .
CONCLUSIONS	Raloxifene effect on bioactive IGF1 is similar to that of estrogen despite higher IGFBP3 levels during raloxifene administration .
CONCLUSIONS	We conclude that the observed different effects on LBM between raloxifene and estrogen treatments can not be explained by differences in IGF1 bioactivity .

###24535621
BACKGROUND	The purpose of this study was to determine the safety and effectiveness , as assessed by risk of bleeding and incidence of deep venous thrombosis ( DVT ) , of administering delayed low-molecular-weight heparin ( LMWH ) after total knee arthroplasty .
METHODS	A prospective study of 210 consecutive patients undergoing primary unilateral total knee arthroplasty was undertaken .
METHODS	The patients were randomized into two groups : one of which was managed according to a standard LMWH program ( LMWH-s group ) and the other with delayed LMWH ( LMWH-p ) .
METHODS	LMWH was initiated 12h after wound closure in the LMWH-s group , and 24h after wound closure in the LMWH-p group .
RESULTS	The total blood loss in the first three postoperative days was calculated and all complications were recorded .
RESULTS	The mean total blood loss was 435 and 387mL in the LMWH-s group and LMWH-p group , respectively ( p < 0.01 ) .
RESULTS	No significant difference in the incidence of symptomatic DVT was observed .
RESULTS	The mean length of hospital stay was 7.29 days in the LMWH-s group and 6.56 days in the LMWH-p group ( p < 0.05 ) .
CONCLUSIONS	After total knee arthroplasty , LMWH-p is safer for bleeding than LMWH-s and equally effective concerning prevention of DVT .

###24289111
BACKGROUND	Parenting programs could provide effective routes to increasing children 's physical activity and reducing screen-viewing .
BACKGROUND	Many studies have reported difficulties in recruiting and retaining families in group parenting interventions .
BACKGROUND	This paper uses qualitative data from the Teamplay feasibility trial to examine parents ' views on recruitment , attendance and course refinement .
METHODS	Semi-structured interviews were conducted with 16 intervention and 10 control group parents of 6-8 year old children .
METHODS	Topics discussed with the intervention group included parents ' views on the recruitment , structure , content and delivery of the course .
METHODS	Topics discussed with the control group included recruitment and randomization .
METHODS	Interviews were digitally recorded , transcribed and thematically analyzed .
RESULTS	Many parents in both the intervention and control group reported that they joined the study because they had been thinking about ways to improve their parenting skills , getting ideas on how to change behavior , or had been actively looking for a parenting course but with little success in enrolling on one .
RESULTS	Both intervention and control group parents reported that the initial promotional materials and indicative course topics resonated with their experiences and represented a possible solution to parenting challenges .
RESULTS	Participants reported that the course leaders played an important role in helping them to feel comfortable during the first session , engaging anxious parents and putting parents at ease .
RESULTS	The most commonly reported reason for parents returning to the course after an absence was because they wanted to learn new information .
RESULTS	The majority of parents reported that they formed good relationships with the other parents in the group .
RESULTS	An empathetic interaction style in which leaders accommodated parent 's busy lives appeared to impact positively on course attendance .
CONCLUSIONS	The data presented indicate that a face-to-face recruitment campaign which built trust and emphasized how the program was relevant to families positively affected recruitment in Teamplay .
CONCLUSIONS	Parents found the parenting component of the intervention attractive and , once recruited , attendance was facilitated by enjoyable sessions , empathetic leaders and support from fellow participants .
CONCLUSIONS	Overall , data suggest that the Teamplay recruitment and retention approaches were successful and with small refinements could be effectively used in a larger trial .

###24341324
OBJECTIVE	This study evaluated whether adding a preoperative single thoracic paravertebral block ( TPVB ) to intravenous patient-controlled analgesia ( IV PCA ) would improve postoperative analgesia compared with using IV PCA alone in patients undergoing nephrectomy .
METHODS	Prospective , randomized , controlled , observer-blinded trial .
METHODS	University hospital .
METHODS	Thirty-four adult patients undergoing elective open nephrectomy .
METHODS	The patients were randomized to receive a TPVB plus IV PCA ( group T ) or IV PCA alone ( group C ) .
METHODS	A single 18-mL injection of 0.75 % ropivacaine was administered preoperatively under ultrasound guidance ; fentanyl was used for IV PCA .
METHODS	Each patient 's postoperative pain score based on a verbal numerical rating scale , postoperative fentanyl consumption , inspiratory volume by incentive spirometry , and complications were evaluated at 1 , 3 , 6 , 12 , and 24 hours after surgery .
METHODS	Changes in heart rate ( HR ) , systolic arterial pressure ( SAP ) , and mean arterial pressure ( MAP ) were evaluated following skin incision .
RESULTS	The postoperative pain score and fentanyl consumption were significantly lower in group T than in group C at all time points up to 24 hours after surgery .
RESULTS	The postoperative inspiratory volumes were not significantly different .
RESULTS	The changes in HR were similar , while the increases in SAP and MAP after skin incision were lower in group T than in group C.
CONCLUSIONS	A preoperative single TPVB improved postoperative analgesia by reducing the postoperative pain score and fentanyl consumption in patients undergoing nephrectomy .

###25090856
BACKGROUND	Undamaged medical gloves protect medical personnel from contact with physiological fluids of the patient .
BACKGROUND	Thus they protect the assistance provider from hand skin contamination with potentially infectious biological materials .
BACKGROUND	The aim of the study was to evaluate the occurrence of pierce , perforations or damage of medical gloves during cannulation of blood vessels .
METHODS	In the prospective randomized study 303 pairs of gloves , used during cannulation of blood vessels under simulated resuscitation , were analyzed .
METHODS	Gloves were tested by the water leak test .
RESULTS	The water test revealed 44 cases of damage to the gloves used during cannulation of blood vessels .
RESULTS	Significant differences were noted in the frequency of damage to both the outer and single pairs of gloves and the inner pair of gloves .
CONCLUSIONS	The study showed that the use of double gloves provides a higher level of security for a paramedic than the use of a single pair of gloves , however , double gloves reduce the manual dexterity of a paramedic .
CONCLUSIONS	A large number of damages to gloves are not noticed by medical personnel during surgery .

###24417761
BACKGROUND	In this study we aimed to investigate the effects of dexmedetomidine on early stage renal function in pediatric patients undergoing cardiac angiography .
METHODS	60 pediatric patients between 6 and 72 months of age undergoing cardiac angiography were included in the study .
METHODS	Patients were divided into two groups .
METHODS	The patients in both groups were administered 1 mg kg ( -1 ) ketamine , 1 mg kg ( -1 ) propofol as bolus and followed by 1 mg kg ( -1 ) h ( -1 ) ketamine and 50 g kg ( -1 ) min ( -1 ) propofol infusion .
METHODS	Additionally , a loading dose of 1 g kg ( -1 ) dexmedetomidine given over 10 min followed by 0.5 g kg ( -1 ) h ( -1 ) dexmedetomidine infusion to patients in group D.
METHODS	The patients were evaluated for NGAL , creatinine , renin , endothelin-1 , TAS and TOS blood levels before the procedure and 6th and 24th h after the procedure .
METHODS	pRIFLE criteria were used to define CIN and its incidence in the study .
RESULTS	According to pRIFLE criteria contrast-induced acute kidney injury developed in 3 ( 10 % ) of the patients in group D and 11 ( 36.7 % ) of the patients in group C ( P = 0.029 , risk ratio = 0.27 ; 95 % CI : 0.084-0 .88 ) .
RESULTS	In patients who developed CIN , Endothelin-1 levels in groups C and D were significantly higher than baseline levels at 6th , 24th and 6th h , respectively .
RESULTS	Renin levels were significantly increased at 6th and 24 th ( ) h in patients with CIN in both groups .
CONCLUSIONS	Dexmedetomidine may be beneficial in protecting against contrast-induced nephropathy during pediatric angiography by preventing the elevation of vasoconstrictor agents such as plasma endothelin-1 and renin .

###24639271
OBJECTIVE	To evaluate whether daily administration of Lactobacillus reuteri DSM 17938 reduces the frequency and duration of diarrheal episodes and other health outcomes in day school children in Mexico .
METHODS	Healthy children ( born at term , aged 6-36 months ) attending day care centers were enrolled in this randomized , double-blind , placebo-controlled trial .
METHODS	They received L reuteri DSM 17938 ( dose 10 ( 8 ) colony-forming unit ; n = 168 ) or identical placebo ( n = 168 ) by mouth , daily for 3 months , after which they were followed-up after a further 3 months without supplementation .
RESULTS	Data from all children were included in the final analysis .
RESULTS	L reuteri DSM 17938 significantly reduced the frequency and duration of episodes of diarrhea and respiratory tract infection at both 3 and 6 months ( P < .05 ) .
RESULTS	Additionally , the number of doctor visits , antibiotic use , absenteeism from day school and parental absenteeism from work were significantly reduced in the L reuteri group ( P < .05 ) .
RESULTS	A cost-benefit analysis revealed significant reductions in costs in the L reuteri-treated children .
RESULTS	No adverse events related to the study product were reported .
CONCLUSIONS	In healthy children attending day care centers , daily administration of L reuteri DSM 17938 had a significant effect in reducing episodes and duration of diarrhea and respiratory tract infection , with consequent cost savings for the community .

###26237828
OBJECTIVE	To observe the clinical effect on type 2 diabetes mellitus ( T2DM ) complicated with pulmonary tuberculosis ( TB ) of insulin , isoniazid , rifampicin , pyrazinamide and ethambutol ( conventional medication ) administered together with Qi-boosting and Yin-nourishing decoction derived from Traditional Chinese Medicine ( TCM ) .
METHODS	A total of 60 patients with T2DM complicated with pulmonary TB were randomly and equally divided into positive control group and treatment group .
METHODS	The control group was treated with Western conventional regiment ( WCR ) : insulin , isoniazid , rifampicin , pyrazinamide , and ethambutol , whereas the treatment group was given both WCR and Qi-boosting and Yin-nourishing decoction prepared from TCM .
RESULTS	After the treatment , 20 ( 66.7 % ) and 11 ( 36.7 % ) cases showed sputum bacteria negative conversion in the WCR plus TCM group and WCM group respectively ( P < 0.05 ) .
RESULTS	A total of 25 ( 83.3 % ) and 18 ( 60 % ) cases showed improvement in lung lesion in the WCR plus TCM group and WCM group respectively ( P < 0.05 ) .
RESULTS	Compared with WCR group , fasting plasma glucose and 2-hour postprandial blood glucose levels in the WCR plus TCM group significantly decreased ( P < 0.05 and P < 0.01 , respectively ) .
CONCLUSIONS	Qi-boosting and Yin-nourishing decoction combined with the Western medication showed better curative effect in treating T2DM complicated with pulmonary TB compared with the group using the conventional Western Medicine alone .

###25137846
OBJECTIVE	To explore the effect of Chinese drugs for Pi strengthening Shen benefiting ( CDPSSB ) on the immunity function of HIV/AIDS patients ' specific T cells .
METHODS	Totally 20 patients were randomly recruited from the treated group [ treated by CDPSSB combined highly active anti-retroviral therapy ( HAART ) ] and 23 patients were randomly recruited from the control group ( treated by HAART alone ) .
METHODS	All patients were follow-up infected persons form You'an Hospital between from June 2010 to June 2012 .
METHODS	CD4 + T absolute counts and HIV viral load were detected .
METHODS	Meanwhile , HIV whole gene overlapping peptides were used as stimulating antigen .
METHODS	The response intensity of HIV specific T cells was detected in the two groups .
RESULTS	There was no statistical difference in CD4 T absolute counts or HIV viral load between the two groups ( P > 0.05 ) .
RESULTS	The response intensity of HIV specific T cells was significantly enhanced in the treated group , when compared with the control group ( P < 0.05 ) .
RESULTS	Along with elongation of treatment time ( 6 , 12 , 18 , and 24 months ) in the treated group , the response intensity of HIV specific T cells showed enhancing tendency , but there was no statistical difference among these time points ( P > 0.05 ) .
CONCLUSIONS	CDPSSB could enhance improve the immunity function of HIV specific T cells , which might be one of its mechanisms .

###24501164
OBJECTIVE	To evaluate the effectiveness of topical eutectic mixture of local anaesthetics ( EMLA ) cream in reducing the pain associated with vaccination injections .
METHODS	This was a randomized , double-blind , placebo-controlled study that included children who presented for routine immunization .
METHODS	Eligible children were randomly assigned to receive either EMLA or placebo cream .
METHODS	The Modified Behavioural Pain Scale ( MBPS ) was used to assess baseline and postvaccination pain scores , while a visual analogue scale ( VAS ) was used to assess pain at the time of the needle prick and at the end of the injection .
RESULTS	A total of 107 children were enrolled in the EMLA group and 109 children in the placebo group .
RESULTS	The difference between the pre - and postvaccination MBPS scores was significantly lower in the EMLA group than in the placebo group ( 2.56 1.96 versus 3.95 2.20 , respectively ) .
RESULTS	The VAS scores at the time of the needle prick and after the injection were significantly lower in the EMLA group compared with the placebo group ( 1.60 1.67 versus 3.24 2.01 ; 3.29 2.27 versus 4.86 2.20 ; respectively ) .
CONCLUSIONS	Application of EMLA cream can be effectively incorporated as a routine pain-relieving intervention within routine vaccination appointments .

###24907721
OBJECTIVE	Few data regarding viral replication in patients receiving belatacept are available .
OBJECTIVE	The aim of this single-center study was to compare the incidence of viral infections ( cytomegalovirus , Epstein Barr virus , BK virus , and JC virus ) , in 62 de novo kidney transplant patients enrolled in the BENEFIT studies , receiving either belatacept ( n = 42 ) or cyclosporine ( n = 20 ) .
METHODS	By means of polymerase chain reaction , belatacept-treated patients were tested for cytomegalovirus , Epstein-Barr virus , BK virus , and JC virus infections monthly for 36 months , monthly for the first 6 months , and then quarterly for 36 months in cyclosporine-treated patients .
METHODS	Additional samples were obtained when a viral infection was suspected .
RESULTS	The number of positive cytomegalovirus , BK virus , or JC virus viremias over the number of polymerase chain reactions performed through all 3 years was similar in both groups .
RESULTS	Conversely , over the 3-year study , the number of positive Epstein-Barr virus viremias over the number of Epstein-Barr virus polymerase chain reactions performed was significantly higher in the belatacept group ( 76 % vs 50 % ; P = .047 ) .
RESULTS	The number of Epstein-Barr virus primary infection was similar in both groups , while the number of Epstein-Barr virus reactivation was higher in the belatacept group .
CONCLUSIONS	Epstein-Barr virus replication occurs more often in patients receiving belatacept , than it does in those receiving cyclosporine .

###24938526
BACKGROUND	A subset of HIV-1 infected patients starting highly active antiretroviral treatment ( HAART ) experience suboptimal CD4 response ( SCR ) despite virologic suppression .
BACKGROUND	We studied the rate of and risk factors for SCR among women starting HAART in the ACTG A5208 study conducted in 7 African countries .
BACKGROUND	741 HAART-naive women with screening CD4 count < 200 cells/L were randomized to start HAART with Tenofovir/Emtricitabine plus either Nevirapine or Lopinavir/Ritonavir .
METHODS	This analysis includes the 625 women who remained on-study through 48 weeks without experiencing protocol-defined virologic failure .
METHODS	We defined SCR as < 100 CD4 cells/L increase from baseline and absolute CD4 cell count < 350 cells/L , both at 48 weeks after HAART initiation .
RESULTS	The baseline characteristics for the 625 women prior to HAART initiation were : median age 33 years , screening CD4 count 134 cells/L , and HIV-1 RNA 5.1 log10 copies/mL ; 184 ( 29 % ) were WHO Stage 3 or 4 .
RESULTS	Seventy one ( 11 % ) of these 625 women experienced SCR .
RESULTS	Baseline factors independently associated with increased odds of SCR included older age , lower HIV-1 RNA , positive Hepatitis B surface antigen , and site location .
RESULTS	At 96 weeks , only 6 % of the SCR group had CD4 350 cells/L compared with 67 % in the non SCR group .
CONCLUSIONS	After starting HAART , 11 % of women with virologic suppression through 48 weeks experienced SCR .
CONCLUSIONS	These patients were also less likely to achieve CD4 350 cells/L by 96 weeks .
CONCLUSIONS	The underlying causes and long term clinical implications of SCR deserve further investigation .
BACKGROUND	Clinicaltrials.gov Identifier : NCT00089505 .

###24485398
OBJECTIVE	To investigate the effect on glycaemic control of adding glimepiride to on-going treatment with metformin and insulin in patients with known diabetes more than 10 years .
METHODS	Glimepiride 4 mg or placebo was added in randomised order for three months with a washout period of 6 weeks .
METHODS	All insulin regimens were allowed .
METHODS	Insulin doses were reduced if considered necessary .
METHODS	Continuous glucose monitoring was performed at the end of each period .
RESULTS	Forty-three patients , median age 66 years ( 46-74 ) , diabetes duration 16 ( 10-30 ) , BMI 30 kg/m ( 2 ) ( 25-37 ) and mean HbA1c 7.1 % NGSP , ( 64 mmol/mol IFCC ) were randomised .
RESULTS	With placebo there was no change in HbA1c while a decrease of 0.6 % , ( 7 mmol/mol IFCC ) ( P < 0.001 ) , was observed with glimepiride even though insulin doses had to be reduced in 23 patients ( median change 29 % , range 2-100 % ) .
RESULTS	Minor hypoglycaemia was reported but no severe hypoglycaemic event was observed .
RESULTS	The ratio between C-peptide/glucose increased significantly ( P < 0.001 ) with glimepiride , both fasting and postprandially and , in a stepwise multiple regression analysis of possible predictive factors for response , a more pronounced decrease in HbA1c was associated with the magnitude of the increment in C-peptide/glucose .
RESULTS	Older age was associated with a smaller response .
RESULTS	Twenty-nine patients ( 67 % ) were defined as responders if this was defined as an HbA1c decrease 0.5 % ( 5 mmol/mol IFCC ) or an insulin dose reduction 20 % .
CONCLUSIONS	Even after long duration of diabetes , addition of glimepiride to insulin and metformin can be effective in lowering HbA1c and/or reducing the need for exogenous insulin .

###24418359
BACKGROUND	Rectal cancer predominantly affects the elderly .
BACKGROUND	Unfortunately , this age category is under-represented in clinical trials because clinicians are loath to include patients with a high risk of comorbidity .
METHODS	An exploratory analysis of the ACCORD12/PRODIGE 2 phase III trial was carried out to retrospectively compare the benefit of neoadjuvant chemotherapy between the elderly ( 70 years ; n = 142 ) and younger patients ( < 70 years ; n = 442 ) , this analysis was not preplanned in the study protocol .
METHODS	Patients with histologically confirmed resectable stage T3 or T4 rectal adenocarcinoma were eligible with an age limit of 80 years .
RESULTS	Overall , the two age categories did not statistically differ in terms of patient 's clinical and tumor baseline characteristics .
RESULTS	Preoperative chemoradiotherapy leads to more severe grade 3/4 toxicities ( 25.6 % vs. 15.8 % , p = 0.01 ) and more permanent stomas ( 33.3 % vs. 22.8 % , p = 0.014 ) in elderly patients who were less often operated on than younger patients ( 95.8 % vs. 99.0 % , p = 0.008 ) .
RESULTS	The relative number of interventions per surgery type ( p = 0.18 ) , treatment efficacy in terms of R0 resection rate ( 88.6 % vs. 90.6 % ; p = 0.54 ) and complete pathological response ( 14.7 % vs. 16.9 % ; p = 0.55 ) were nearly identical between the two categories .
CONCLUSIONS	Altogether these results warrant the development of specific optimal therapeutic strategies for the elderly .

###24386468
OBJECTIVE	Chronic hand and wrist pain is a common clinical issue for orthopaedic surgeons and rheumatologists .
OBJECTIVE	The purpose of this study was 1 .
OBJECTIVE	To analyze the interobserver agreement of SPECT/CT , MRI , CT , bone scan and plain radiographs in patients with non-specific pain of the hand and wrist , and 2 .
OBJECTIVE	to assess the diagnostic accuracy of these imaging methods in this selected patient population .
METHODS	Thirty-two consecutive patients with non-specific pain of the hand or wrist were evaluated retrospectively .
METHODS	All patients had been imaged by plain radiographs , planar early-phase imaging ( bone scan ) , late-phase imaging ( SPECT/CT including bone scan and CT ) , and MRI .
METHODS	Two experienced and two inexperienced readers analyzed the images with a standardized read-out protocol .
METHODS	Reading criteria were lesion detection and localisation , type and etiology of the underlying pathology .
METHODS	Diagnostic accuracy and interobserver agreement were determined for all readers and imaging modalities .
RESULTS	The most accurate modality for experienced readers was SPECT/CT ( accuracy 77 % ) , followed by MRI ( 56 % ) .
RESULTS	The best performing , though little accurate modality for inexperienced readers was also SPECT/CT ( 44 % ) , followed by MRI and bone scan ( 38 % each ) .
RESULTS	The interobserver agreement of experienced readers was generally high in SPECT/CT concerning lesion detection ( kappa 0.93 , MRI 0.72 ) , localisation ( kappa 0.91 , MRI 0.75 ) and etiology ( kappa 0.85 , MRI 0.74 ) , while MRI yielded better results on typification of lesions ( kappa 0.75 , SPECT/CT 0.69 ) .
RESULTS	There was poor agreement between experienced and inexperienced readers in SPECT/CT and MRI .
CONCLUSIONS	SPECT/CT proved to be the most helpful imaging modality in patients with non-specific wrist pain .
CONCLUSIONS	The method was found reliable , providing high interobserver agreement , being outperformed by MRI only concerning the typification of lesions .
CONCLUSIONS	We believe it is beneficial to integrate SPECT/CT into the diagnostic imaging algorithm of chronic wrist pain .

###24526247
OBJECTIVE	TREATMENT of patients with chronic low back pain ( CLBP ) aims to reduce disability , improve functional capacity , and participation .
OBJECTIVE	Time contingent prescription of analgesics is a treatment modality in CLBP .
OBJECTIVE	The impact of analgesics on functional capacity is unknown .
OBJECTIVE	Aim of the study was to explore the effect of analgesics on functioning measured by functional capacity evaluation , and self-reported disability in patients with CLBP .
METHODS	Explorative Randomized Placebo-Controlled Clinical Trial was performed in an outpatient pain rehabilitation setting on patients waiting for rehabilitation .
METHODS	Included patients had low back pain lasting > 3 months , visual analogue scale worst pain 4.0 cm , and age > 18 years .
METHODS	Outcome measures before ( T0 ) and after treatment ( T1 ) : functional capacity , pain intensity , Roland Morris Disability Questionnaire .
METHODS	T1 : global perceived pain relief .
METHODS	Patient characteristics and psychological questionnaires were assessed .
METHODS	Fifty patients were included in this study and were randomly assigned to 2 weeks treatment or placebo .
METHODS	acetaminophen/tramadol 325 mg/37 .5 mg per capsule .
METHODS	Dose : maximum acetaminophen 1,950 mg and tramadol 225 mg per day ; treatment and placebo titrated identically .
METHODS	Compliance and side-effects were monitored .
METHODS	TREATMENT effects between groups over time were compared .
RESULTS	One patient ( treatment group ) was lost to follow-up .
RESULTS	Forty-nine patients remained in the study .
RESULTS	TREATMENT effects in primary outcomes did not differ significantly between groups .
RESULTS	A subgroup of 10 ( 42 % ) patients ( treatment group ) reported global pain relief ( responders ) who reduced self-reported disability ( p < 0.05 ) .
RESULTS	Responders had significantly lower catastrophizing scores .
CONCLUSIONS	Overall treatment effects were small and non-significant .
CONCLUSIONS	A subgroup , however , reported improved functioning as a result of treatment .
CONCLUSIONS	Responders had lower catastrophizing scores .

###24475284
BACKGROUND	Circadian variation in bodily functions has been shown to impact health in acute and chronic medical conditions .
BACKGROUND	Little is known about the relationship between circadian rhythm and sepsis in humans .
BACKGROUND	We aimed to investigate circadian variations in the host response in a human endotoxaemia model .
METHODS	A cross-over study , where 12 healthy young men received E. coli endotoxin ( lipopolysaccharide , LPS ) 0.3 ng/kg at 12 noon and , on another day , at 12 midnight .
METHODS	Blood samples were analysed for pro- and anti-inflammatory cytokines : tumour-necrosis factor ( TNF ) - alpha , soluble TNF receptors ( sTNF-R ) -1 and -2 , interleukin ( IL ) -1 beta , IL-1 receptor antagonist ( IL-1Ra ) , IL-6 , and IL-10 as well as YKL-40 and the oxidative stress markers malondialdehyde ( MDA ) , ascorbic acid ( AA ) and dehydroascorbic acid ( DHA ) before and at 2 , 4 , 6 and 8 hours after LPS administration .
RESULTS	The levels of MDA and IL-10 where significantly higher during the day time ( P < 0.05 ) whereas levels of TNF-alpha , sTNF-RI , sTNF-RII , IL-1Ra , IL-6 , and YKL-40 were higher ( P < 0.01 for all comparisons ) during the night time .
RESULTS	No significant differences were seen in the levels of AA and DHA .
CONCLUSIONS	A day-night difference in the acute phase response to endotoxaemia exists in healthy volunteers with a more pronounced inflammatory response during the night time .
CONCLUSIONS	This circadian difference in the response to endotoxaemia may play an important role in the clinical setting and should be investigated further .

###25058250
BACKGROUND	The study aimed to establish the benefits of using chest tubes with negative pleural suction against trapped water in patients with penetrating or blunt chest trauma who underwent tube thoracostomy , in terms of the incidence of complications , such as persistent air leak , clotted hemothorax , empyema , and duration of stay .
METHODS	Patients who underwent tube thoracostomy because of traumatic pneumothorax , hemothorax , or hemopneumothorax were randomly assigned into one of two groups : in Group 1 , the three-bottle drainage system was connected to a negative suction ; in Group 2 , no suction was given .
METHODS	Patients who required mechanical ventilation or emergency surgery ( thoracotomy or thoracoscopy ) either at the time of admission to the institution or immediately after the tube thoracostomy , patients who had histories of thoracic procedures or chronic pulmonary diseases ( chronic obstructive pulmonary disease , diffuse interstitial lung disease ) , and patients with multiple injuries with severe traumatic brain injury and a Glasgow Coma Scale ( GCS ) score less than 8 of 15 were excluded from the study .
METHODS	Hospital stay , duration of tube thoracostomy , prolonged fistula , and other clinical variables were compared .
RESULTS	One hundred ten patients were included , 56 in the group with suction and 54 in the group without suction .
RESULTS	There were no differences in the demographic characteristics of each group .
RESULTS	There were no differences between the groups in terms of hospital stay ( p = 0.22 ) , duration of tube thoracostomy ( p = 0.35 ) ( 3 days in each group ) , or complications .
RESULTS	However , the probability of air leak presence in time was greater for the Group 1 patients with negative suction versus the Group 2 patients ( p = 0.023 ) .
CONCLUSIONS	The use of negative pleural suction did not demonstrate advantages over the three-bottle chest drainage system without suction in patients with uncomplicated traumatic pneumothorax , hemothorax , or hemopneumothorax .
METHODS	Therapeutic study , level II .

###24969776
OBJECTIVE	The ability of apolipoprotein A-I ( apoA-I ) to transport cholesterol from atherosclerotic plaque is thought to underlie its inverse correlation with cardiovascular risk .
OBJECTIVE	To gauge the potential of infused apoA-I to transport cholesterol , we quantified cholesterol transport markers in human subjects infused with a novel formulation of apoA-I ( CSL112 ) .
RESULTS	CSL112 was infused into human subjects in single ( 57 subjects ) and multiple ( 36 subjects ) ascending dose trials .
RESULTS	Pharmacokinetic and biomarker assessments were conducted before and after infusions .
RESULTS	CSL112 caused an immediate , up to 3-fold elevation of apoA-I and subsequent movement of tissue cholesterol into plasma .
RESULTS	Cholesterol appeared first as unesterified cholesterol in the high-density lipoprotein ( HDL ) fraction and was promptly esterified by lecithin cholesterol acyltransferase .
RESULTS	HDL cholesterol increased up to 8116.5 % .
RESULTS	Underlying this movement of cholesterol was an immediate and strong rise in the ability of plasma to promote cholesterol efflux from cells ex vivo .
RESULTS	CSL112 had its greatest impact on the fraction of efflux mediated by ATP-binding cassette transporter A1 ( ABCA1 ) , a cholesterol transporter induced in cholesterol-loaded tissues such as plaque .
RESULTS	ABCA1-dependent efflux capacity increased 630421 % and total efflux capacity by 19240 % .
RESULTS	In keeping with this finding , we observed a profound rise in very small HDL , also known as pre1-HDL , the preferred substrate for ABCA1 .
RESULTS	Very small HDL increased 3596941 % .
RESULTS	Elevations in apoA-I , cholesterol efflux , and very small HDL were dose-proportional over a wide range .
RESULTS	No significant changes in atherogenic lipids were observed at any dose .
CONCLUSIONS	Infusion of CSL112 elevates the ability of plasma to withdraw cholesterol from cells .
CONCLUSIONS	Preferential elevation of ABCA1-dependent efflux may target atherosclerotic plaque for cholesterol removal , making CSL112 a promising candidate therapy for acute coronary syndrome .

###24716820
BACKGROUND	We assessed the impact of using an automated bolus advisor integrated into a blood glucose meter on the timing and frequency of adjusting insulin therapy parameter settings and whether the availability of this technology would increase blood glucose test strip utilization in diabetes patients treated with multiple daily insulin injection ( MDI ) therapy .
METHODS	The Automated Bolus Advisor Control and Usability Study ( ABACUS ) trial , a 26-week , prospective , randomized , controlled , multinational study that enrolled 218 type 1 and type 2 diabetes patients , demonstrated that use of an automated insulin bolus advisor helps improve glycemic control in suboptimally controlled , MDI-treated patients .
METHODS	Patient data were assessed to determine when and how often changes in insulin parameter settings occurred during the study .
METHODS	Patient meters were downloaded to determine blood glucose monitoring frequency .
RESULTS	One hundred ninety-three patients completed the study : 93 control arm ( CNL ) and 100 intervention ( experimental ) arm ( EXP ) .
RESULTS	Significantly more EXP ( 47.5 % ) than CNL ( 30.7 % ) patients received one or more changes in their insulin sensitivity factor ( ISF ) settings during the study ( P = 0.0191 ) .
RESULTS	Changes in ISF settings occurred earlier and more frequently in EXP than CNL patients throughout the study .
RESULTS	A similar trend was seen in changes in insulin-to-carbohydrate ratios .
RESULTS	There were no differences in daily self-monitoring of blood glucose frequency [ mean ( SD ) ] between CNL and EXP patients : 4.7 ( 1.5 ) versus 4.6 ( 1.3 ) ( P = 0.4085 ) .
CONCLUSIONS	Use of an automated bolus advisor was associated with earlier , more frequent changes in key insulin parameters , which may have contributed to subsequent improvements in glycemic control but without increased glucose test strip utilization .

###26233970
OBJECTIVE	This study was designed to describe and evaluate the use of a vascularized marginal periosteal barrier membrane ( MPM ) harvested by a semilunar incision , alone or combined with a bone graft , in treatment of class II furcation defects in mandibular molars , compared to open flap debridement ( OFD ) .
METHODS	Thirty class II furcation defects in mandibular molars were randomly assigned into three equal groups : Group I included OFD , Group II included defects treated with MPM , and Group III consisted of defects treated with MPM after applying demineralized freeze-dried bone allograft ( DFDBA ) .
METHODS	At baseline and 6-month follow-up , vertical probing depth ( VPD ) , clinical attachment level ( CAL ) measurements , along with a radiographic measurement of bone height ( BH ) , were obtained for each defect .
METHODS	Transmission electron microscopy ( TEM ) was used for further evaluation of the histological changes associated with gingival samples related to each line of treatment .
RESULTS	Both Groups II and III reflected significant favorable outcomes in all the assessed parameters compared to OFD .
RESULTS	A non-significant difference was found between both groups regarding VPD , while significant improvement in CAL and BH were detected in Group III ( p 0.05 ) .
RESULTS	Favorable histological findings were also noticed in the test groups , with more improvement in Group III .
CONCLUSIONS	Placement of a vascularized MPM as a barrier membrane , using a semilunar incision , demonstrated a significant improvement in both clinical and histological outcomes of class II furcation defects in lower molars .
CONCLUSIONS	When it was combined with DFDBA , a meaningful difference was found with regard to early wound healing and gain in CAL and BH .

###24338242
OBJECTIVE	Capnography enables the measurement of end-tidal CO2 and thereby the early detection of apnea , prompting immediate intervention to restore ventilation .
OBJECTIVE	Studies have shown that capnographic monitoring is associated with a reduction of hypoxemia during sedation for endoscopy and early detection of apnea during sedation for colonoscopy .
OBJECTIVE	The primary aim of this prospective randomized study was to evaluate whether capnographic monitoring without tracheal intubation reduces hypoxemia during propofol-based sedation in patients undergoing colonoscopy .
METHODS	A total of 533 patients presenting for colonoscopy at two study sites were randomized to either standard monitoring ( n = 266 ) or to standard monitoring with capnography ( n = 267 ) .
METHODS	The incidence of hypoxemia ( SO2 < 90 % ) and severe hypoxemia ( SO2 < 85 % ) were compared between the groups .
METHODS	Furthermore , risk factors for hypoxemia were evaluated , and sedation performed by anesthesiologists was compared with nurse-administered propofol sedation ( NAPS ) or endoscopist-directed sedation ( EDS ) .
RESULTS	The incidence of hypoxemia was significantly lower in patients with capnography monitoring compared with those receiving standard monitoring ( 18 % vs. 32 % ; P = 0.00091 ) .
RESULTS	Independent risk factors for hypoxemia were age ( P = 0.00015 ) , high body mass index ( P = 0.0044 ) , history of sleep apnea ( P = 0.025 ) , standard monitoring group ( P = 0.000069 ) , total dose of propofol ( P = 0.031 ) , and dose of ketamine ( P < 0.000001 ) .
RESULTS	Patients receiving anesthesiologist-administered sedation developed hypoxemic events more often than those receiving NAPS or EDS.In patients with anesthesiologist-administered sedation , sedation was deeper , a combination of sedative medication ( propofol , midazolam and/or ketamine ) was administered significantly more often , and sedative doses were significantly higher compared with patients receiving NAPS or EDS .
CONCLUSIONS	In patients undergoing colonoscopy during propofol-based sedation capnography monitoring with a simple and inexpensive device reduced the incidence of hypoxemia .

###25056958
BACKGROUND	Serum N-terminal pro-C-natriuretic peptide ( NT-proCNP ) concentration at hospital admission has sufficient sensitivity and specificity to differentiate naturally occurring sepsis from nonseptic systemic inflammatory response syndrome ( SIRS ) .
BACKGROUND	However , little is known about serum NT-proCNP concentrations in dogs during the course of sepsis .
OBJECTIVE	To determine serum NT-proCNP and cytokine kinetics in dogs with endotoxemia , a model of canine sepsis .
METHODS	Eighty canine serum samples .
METHODS	Eight healthy adult Beagles were randomized to receive Escherichia coli lipopolysaccharide ( LPS , 5 g/kg ) or placebo ( 0.9 % NaCl ) as a single IV dose in a randomized crossover study .
METHODS	Serum collected at 0 , 1 , 2 , 4 , and 24 hours was stored at -80 C for batch analysis .
METHODS	Serum NT-proCNP was measured by ELISA and 13 cytokines and chemokines by multiplex magnetic bead-based assay .
RESULTS	Serum NT-proCNP concentrations did not differ significantly between LPS - and placebo-treated dogs at any time .
RESULTS	When comparing serum cytokine concentrations , LPS-treated dogs had higher interleukin-6 ( IL-6 ) , IL-10 , TNF - and KC-like at 1 , 2 , and 4 hours ; higher CCL2 at 1 , 2 , 4 , and 24 hours ; and higher IL-8 and CXCL10 at 4 hours compared to placebo-treated dogs .
RESULTS	There were no differences in serum GM-CSF , IFN - , IL-2 , IL-7 , IL-15 or IL-18 between LPS - and placebo-treated dogs .
CONCLUSIONS	Serum NT-proCNP concentration does not change significantly in response to LPS administration in healthy dogs .
CONCLUSIONS	Certain serum cytokine and chemokine concentrations are significantly increased within 1-4 hours after LPS administration and warrant further investigation as tools for the detection and management of sepsis in dogs .

###25559202
BACKGROUND	Promotion of healthy pregnancies has gained high priority in the Netherlands because of relatively unfavorable perinatal outcomes .
BACKGROUND	In response , a nationwide study , ` Healthy Pregnancy 4 All ' ( HP4ALL ) , has been initiated .
BACKGROUND	Part of this study involves systematic and broadened antenatal risk assessment ( the Risk Assessment substudy ) .
BACKGROUND	Risk selection in current clinical practice is mainly based on medical risk factors .
BACKGROUND	Despite the increasing evidence for the influence of nonmedical risk factors ( social status , lifestyle or ethnicity ) on perinatal outcomes , these risk factors remain highly unexposed .
BACKGROUND	Systematic risk selection , combined with customized care pathways to reduce or treat detected risks , and regular and structured consultation between community midwives , gynecologists and other care providers such as social workers , is part of this study .
METHODS	Neighborhoods in 14 municipalities with adverse perinatal outcomes above national and municipal averages are selected for participation .
METHODS	The study concerns a cluster randomized controlled trial .
METHODS	Municipalities are randomly allocated to intervention ( n = 3,500 pregnant women ) and control groups ( n = 3,500 pregnant women ) .
METHODS	The intervention consists of systematic risk selection with the Rotterdam Reproductive Risk Reduction ( R4U ) score card in pregnant women at the booking visit , and referral to corresponding care pathways .
METHODS	A risk score , based on weighed risk factors derived from the R4U , above a predefined threshold determines structured multidisciplinary consultation .
METHODS	Primary outcomes of this trial are dysmaturity ( birth weight < p10 ) , prematurity ( birth < 37weeks ) , and efficacy of implementation .
CONCLUSIONS	The ` HP4ALL ' study introduces a systematic approach in antenatal health care that may improve perinatal outcomes and , thereby , affect future health status of a new generation in the Netherlands .
BACKGROUND	Dutch Trial Registry ( NTR-3367 ) on 20 March 2012 .

###25194768
OBJECTIVE	To compare the efficacy , tolerance , and safety of manual manipulation at day 7 to day 1 following collagenase Clostridium histolyticum ( CCH ) injection for Dupuytren contracture .
METHODS	Eligible patients were randomized to manipulation at day 1 versus day 7 following CCH injection .
METHODS	Preinjection , premanipulation , postmanipulation , and 30-day follow-up metacarpophalangeal ( MCP ) and proximal interphalangeal ( PIP ) joint contractures were measured .
METHODS	Pain scores were recorded at each time point .
METHODS	Data were stratified per cohort based on primary joint treated ( MCP vs PIP ) .
METHODS	Means were compared using paired and unpaired t-tests .
RESULTS	Forty-three patients with 46 digits were eligible and were randomized to 1-day ( 22 digits ) and 7-day ( 24 digits ) manipulation .
RESULTS	For MCP joints , there were no significant differences in flexion contractures between 1 - and 7-day cohorts for initial ( 47 vs 46 ) , postmanipulation ( 0 vs 2 ) , or 30-day follow-up ( 1 vs 2 ) measurements .
RESULTS	Premanipulation , the residual contracture was significantly lower in the 7-day group ( 23 vs 40 ) .
RESULTS	For PIP joints , there were no significant differences between 1 - and 7-day cohorts for initial ( 63 vs 62 ) , premanipulation ( 56 vs 52 ) , postmanipulation ( 13 vs 15 ) , or 30-day ( 14 vs 16 ) measurements .
RESULTS	There were no significant differences in pain or skin tears between the 2 groups .
RESULTS	No flexor tendon ruptures were observed .
CONCLUSIONS	The effectiveness of CCH in achieving correction of Dupuytren contractures was preserved when manipulation was performed on day 7 , with no differences in correction , pain , orskin tears .
CONCLUSIONS	These data suggest that manipulation can be scheduled at the convenience ofthe patient and surgeon within the first 7 days after injection .
METHODS	Therapeutic I.

###25475110
BACKGROUND	The value of aspirin in primary prevention of cancer and cardiovascular disease ( CVD ) remains unclear .
BACKGROUND	The aim of this study was to identify women who benefit from alternate-day aspirin with regard to all relevant outcomes , including cancer , CVD and major gastrointestinal bleeding .
METHODS	Long term follow-up data of 27939 healthy women with baseline plasma samples in the Women 's Health Study , a randomised trial of 100mg alternate-day aspirin versus placebo , were used to develop competing risks models for individualised prediction of absolute risk reduction of the combination of CVD , cancer and major gastrointestinal bleeding by aspirin .
RESULTS	Although aspirin was associated with a modestly decreased 15-year risk of colorectal cancer , CVD , and in some women non-colorectal cancer , aspirin treatment resulted in a negative treatment effect in the majority of women if gastrointestinal bleeding was also taken into account .
RESULTS	The excess risk of major gastrointestinal bleeding by aspirin increased with age , but the benefits for colorectal cancer and CVD risk were also greater at higher age .
RESULTS	Decision curves indicated that selective treatment of women 65years may improve net benefit compared to treating all , none and prediction-based treatment .
RESULTS	The observed 15-year number needed to treat to prevent one event among women 65years was 29 ( 95 % CI 12 to 102 ) .
CONCLUSIONS	Concurrent evaluation of the absolute effects on cancer , CVD and major gastrointestinal bleeding showed that alternate-day use of low-dose aspirin is ineffective or harmful in the majority of women in primary prevention .
CONCLUSIONS	Selective treatment of women 65years with aspirin may improve net benefit .
BACKGROUND	NCT00000479 .

###24645829
BACKGROUND	Although good progress has been achieved in expanding immunization of children in China , disparities exist across different provinces .
BACKGROUND	Information gaps both from the service supply and demand sides hinder timely vaccination of children in rural areas .
BACKGROUND	The rapid development of mobile health technology ( mHealth ) provides unprecedented opportunities for improving health services and reaching underserved populations .
BACKGROUND	However , there is a lack of literature that rigorously evaluates the impact of mHealth interventions on immunization coverage as well as the usability and feasibility of smart phone applications ( apps ) .
BACKGROUND	This study aims to assess the effectiveness of a smart phone-based app ( Expanded Program on Immunization app , or EPI app ) on improving the coverage of children 's immunization .
METHODS	This cluster randomized trial will take place in Xuanhan County , Sichuan Province , China .
METHODS	Functionalities of the app include the following : to make appointments automatically , record and update children 's immunization information , generate a list of children who missed their vaccination appointments , and send health education information to village doctors .
METHODS	After pairing , 36 villages will be randomly allocated to the intervention arm ( n = 18 ) and control arm ( n = 18 ) .
METHODS	The village doctors in the intervention arm will use the app while the village doctors in the control arm will record and manage immunization in the usual way in their catchment areas .
METHODS	A household survey will be used at baseline and at endline ( 8 months of implementation ) .
METHODS	The primary outcome is full-dose coverage and the secondary outcome is immunization coverage of the five vaccines that are included in the national Expanded Program on Immunization program as well as Hib vaccine , Rotavirus vaccine and Pneumococcal conjugate vaccine .
METHODS	Multidimensional evaluation of the app will also be conducted to assess usability and feasibility .
CONCLUSIONS	This study is the first to evaluate the effectiveness of a smart phone app for child immunization in rural China .
CONCLUSIONS	This study will contribute to the knowledge about the usability and feasibility of a smart phone app for managing immunization in rural China and to similar populations in different settings .
BACKGROUND	Chinese Clinical Trials Registry ( ChiCTR ) : ChiCTR-TRC-13003960 .

###24220376
OBJECTIVE	We aimed to decrease the postseptoplasty morbidities depending on nasal packing by using Merocel within glove finger moistened with tetracaine 0.25 % solution .
METHODS	The study was designed as a randomized prospective study .
METHODS	A university hospital in Turkey .
METHODS	Our study consisted of 80 patients who underwent septoplasty .
METHODS	The Merocel nasal tampon within glove finger was inserted after surgery in the study group and removed after 24 or 48 hours .
METHODS	Merocel was moistened with tetracaine 0.25 % solution after insertion into the nasal cavity and just before removal .
METHODS	The morbidities and normal breathing time were recorded and compared with those of the control group .
RESULTS	The postseptoplasty morbidities were significantly decreased in the study group compared with those in the control group .
RESULTS	The morbidities were also improved after removal of tampons after 24 hours compared with 48 hours .
RESULTS	However , the normal breathing time was prolonged when the nasal tampons were removed after 24 hours .
CONCLUSIONS	The glove finger provides comfortable removal of nasal packing .
CONCLUSIONS	The Merocel tampons might be safely removed just after 24 hours postoperatively without any complication .

###24974131
OBJECTIVE	Insulin resistance ( IR ) affects sustained virological response ( SVR ) to peginterferon alfa plus ribavirin ( PR ) in patients with chronic hepatitis C ( CHC ) .
OBJECTIVE	Whether add-on oral hypoglycemic agents ( OHAs ) to PR improve SVR remains unclear ; therefore , we conducted a prospective , randomized pilot trial on 23 consecutive patients with genotype 1 CHC and IR in Taiwan .
METHODS	Patients were randomized to receive acarbose ( Arm A ; n = 7 ) or metformin ( Arm B ; n = 6 ) or pioglitazone ( Arm C ; n = 5 ) in addition to peginterferon alfa-2b ( 1.5 g/kg/week ) plus ribavirin ( 1000-1200 mg/day ) or just PR ( Arm D ; n = 5 ) .
METHODS	The primary end point was SVR , and secondary end points were viral clearance at Weeks 17 , 29 , and 53 .
METHODS	There were no differences among all arms at baseline .
RESULTS	Using intent-to-treat analysis , SVR was observed in 66.7 % ( 4/6 ) , 83.3 % ( 5/6 ) , 66.7 % ( 4/6 ) , and 60 % ( 3/5 ) in Arms A , B , C , and D , respectively .
RESULTS	SVR was higher in female patients receiving OHA [ 90 % ( 9/10 ) ] than in male patients [ 50 % ( 4/8 ) ] .
RESULTS	Results of per protocol analysis showed that SVR was 80.0 % ( 4/5 ) in Arm A , 100 % ( 5/5 ) in Arm B , 66.7 % ( 4/6 ) in Arm C , and 60 % ( 3/5 ) in Arm D. Patients receiving OHA had a higher rapid virologic response : 11/18 ( 61 % ) versus 2/5 ( 40 % ) .
RESULTS	Complete early virologic response was comparable between patients receiving OHA and PR [ 15/18 ( 83 % ) vs. 4/5 ( 80 % ) ] .
CONCLUSIONS	Our preliminary data show add-on OHAs to PR might achieve better early viral kinetics and SVR .
CONCLUSIONS	However , further larger studies are needed to confirm these findings .

###24737184
OBJECTIVE	Delayed hair re-growth , pruritus and urinary retention are known complications after epidural anaesthesia in dogs .
OBJECTIVE	The aim of this study was to prospectively evaluate the effect of epidurally administered drugs on the occurrence of these complications in dogs .
METHODS	Ninety dogs were included in this study .
METHODS	Eighty client-owned dogs undergoing surgery were randomly assigned to one of three epidural treatment groups : either morphine and bupivacaine ( MB ) , bupivacaine ( B ) , or saline solution 0.9 % ( S ) was administered epidurally to these patients .
METHODS	Ten dogs were only clipped in the lumbosacral area ( C ) .
METHODS	Follow-up started 4 weeks after clipping and was performed every 4-5 weeks in cases of delayed hair re-growth or pruritus .
METHODS	Hair re-growth in the lumbosacral area was observed and compared to hair re-growth in the surgical field and the fentanyl patch area .
METHODS	Cytological analysis and a trichogram were performed if hair re-growth was delayed after 6 months .
METHODS	Time interval to first urination postoperatively was recorded ( n = 80 ) .
RESULTS	Hair re-growth was delayed in 11 dogs ( 12.2 % ; B : n = 7 , S : n = 2 , MB : n = 1 , C : n = 1 ) with no differences between groups .
RESULTS	Pruritus was evident in two dogs ( 2.2 % ; MB : n = 1 , S : n = 1 ) .
RESULTS	After 6 months , hair had started to re-grow in all but one dog ( B ) .
RESULTS	After 10 months the coat of this dog had re-grown .
RESULTS	Time to first urination did not differ between groups .
CONCLUSIONS	No direct correlation between the particular drugs injected epidurally and delayed hair re-growth , pruritus and urinary retention could be shown .
CONCLUSIONS	Dog owners should be informed that hair re-growth after epidural anaesthesia could be markedly delayed .

###24373681
BACKGROUND	A period of nonsurgical management is advocated before surgical treatment for most patients with lumbar spinal stenosis .
BACKGROUND	Currently , little evidence is available to define optimal nonsurgical management .
BACKGROUND	Physical therapy is often used , however its use and effectiveness relative to other nonsurgical strategies has not been adequately explored .
OBJECTIVE	Describe the use of physical therapy and other nonsurgical interventions by patients with lumbar spinal stenosis and examine the relationship between physical therapy and long-term prognosis .
METHODS	Secondary analysis of the Spine Patient Outcomes Research Trial ( SPORT ) combining data from randomized and observational studies .
METHODS	Thirteen spine clinics in 11 states in the United States .
METHODS	Patients with lumbar spinal stenosis receiving nonsurgical management including those who did or did not receive physical therapy within 6 weeks of enrollment .
METHODS	Primary outcome measures included crossover to surgery , the bodily pain and physical function scales changes from the Survey Short Form 36 ( SF-36 ) , and the modified Oswestry Disability Index .
METHODS	Secondary outcome measures were patient satisfaction and the Sciatica Bothersomeness Index .
METHODS	Baseline characteristics and rates of crossover to surgery were compared between patients who did or did not receive physical therapy .
METHODS	Baseline factors predictive of receiving physical therapy were examined with logistic regression .
METHODS	Mixed effects models were used to compare outcomes between groups at 3 and 6 months and 1 year after enrollment adjusted for baseline severity and patient characteristics .
RESULTS	Physical therapy was used in the first 6 weeks by 90 of 244 patients ( 37 % ) and was predicted by the absence of radiating pain and being single instead of married .
RESULTS	Physical therapy was associated with a reduced likelihood of crossover to surgery after 1 year ( 21 % vs. 33 % , p = .045 ) , and greater reductions on the Short Form 36 physical functioning scale after 6 months ( mean difference = 6.0 , 95 % confidence interval : 0.2-11 .7 ) and 1 year ( mean difference = 6.5 , 95 % confidence interval : 0.6-12 .4 ) .
RESULTS	There were no differences in bodily pain or Oswestry scores across time .
CONCLUSIONS	Many patients with lumbar spinal stenosis pursuing conservative management receive physical therapy .
CONCLUSIONS	Using physical therapy was associated with reduced likelihood of patients receiving surgery within 1 year .
CONCLUSIONS	Results for other outcomes were mixed with no differences in several measures .
CONCLUSIONS	Further research is needed to examine the effectiveness of physical therapy relative to other nonsurgical management strategies for patients with lumbar spinal stenosis .

###25528358
BACKGROUND	Although promising results have emerged regarding oral immunotherapy ( OIT ) and sublingual immunotherapy ( SLIT ) for the treatment of peanut allergy ( PA ) , direct comparisons of these approaches are limited .
OBJECTIVE	This study was conducted to compare the safety , efficacy , and mechanistic correlates of peanut OIT and SLIT .
METHODS	In this double-blind study children with PA were randomized to receive active SLIT/placebo OIT or active OIT/placebo SLIT .
METHODS	Doses were escalated to 3.7 mg/d ( SLIT ) or 2000 mg/d ( OIT ) , and subjects were rechallenged after 6 and 12 months of maintenance .
METHODS	After unblinding , therapy was modified per protocol to offer an additional 6 months of therapy .
METHODS	Subjects who passed challenges at 12 or 18 months were taken off treatment for 4 weeks and rechallenged .
RESULTS	Twenty-one subjects aged 7 to 13 years were randomized .
RESULTS	Five discontinued therapy during the blinded phase .
RESULTS	Of the remaining 16 , all had a greater than 10-fold increase in challenge threshold after 12 months .
RESULTS	The increased threshold was significantly greater in the active OIT group ( 141 - vs 22-fold , P = .01 ) .
RESULTS	Significant within-group changes in skin test results and peanut-specific IgE and IgG4 levels were found , with overall greater effects with OIT .
RESULTS	Adverse reactions were generally mild but more common with OIT ( P < .001 ) , including moderate reactions and doses requiring medication .
RESULTS	Four subjects had sustained unresponsiveness at study completion .
CONCLUSIONS	OIT appeared far more effective than SLIT for the treatment of PA but was also associated with significantly more adverse reactions and early study withdrawal .
CONCLUSIONS	Sustained unresponsiveness after 4 weeks of avoidance was seen in only a small minority of subjects .

###25526908
BACKGROUND	Laser Doppler flowmetry ( LDF ) is widely used for estimating cerebral blood flow changes during intraluminal middle cerebral artery occlusion ( MCAO ) .
BACKGROUND	No investigation has systematically examined LDF efficacy in standardizing outcome .
BACKGROUND	We examined MCAO histologic and behavioral outcome as a function of LDF measurement .
METHODS	Rats were subjected to 90min MCAO by 4 surgeons having different levels of MCAO surgical experience .
METHODS	LDF was measured in all rats during ischemia .
METHODS	By random assignment , LDF values were ( Assisted ) or were not ( Blinded ) made available to each surgeon during MCAO ( n = 12-17 per group ) .
METHODS	Neurologic and histologic outcomes were measured 7 days post-MCAO .
METHODS	A second study examined LDF effects on 1-day post-MCAO outcome .
RESULTS	Pooled across surgeons , intra-ischemic % LDF change ( P = 0.12 ) , neurologic scores ( Assisted vs. Blinded = 146 vs. 137 , P = 0.61 , meanstandard deviation ) and cerebral infarct volume ( 16263mm ( 3 ) vs. 14386mm ( 3 ) , P = 0.24 ) were not different between groups .
RESULTS	Only for one surgeon ( novice ) did LDF use alter infarct volume ( 14528mm ( 3 ) vs. 9861mm ( 3 ) , P = 0.03 ) .
RESULTS	LDF use decreased infarct volume coefficient of variation ( COV ) by 35 % ( P = 0.02 ) , but had no effect on neurologic score COV .
METHODS	We compared intraluminal MCAO outcome as a function of LDF use .
CONCLUSIONS	LDF measurement altered neither neurologic nor histologic MCAO outcome .
CONCLUSIONS	LDF did not decrease neurologic deficit COV , but did decrease infarct volume COV .
CONCLUSIONS	LDF may allow use of fewer animals if infarct volume is the primary dependent variable , but is unlikely to impact requisite sample sizes if neurologic function is of primary interest .

###24708591
BACKGROUND	Dairy food is an important natural source of saturated and trans fatty acids in the human diet .
BACKGROUND	This study evaluates the effect of dietary advice to change dairy food intake on plasma fatty acid levels known to be present in milk in healthy volunteers .
METHODS	Twenty one samples of whole fat dairy milk were analyzed for fatty acids levels .
METHODS	Changes in levels of plasma phospholipid levels were evaluated in 180 healthy volunteers randomized to increase , not change or reduce dairy intake for one month .
METHODS	Fatty acids were measured by gas chromatography-mass spectrometry and levels are normalized to d-4 alanine .
RESULTS	The long chain fatty acids palmitic ( 13.4 % ) , stearic ( 16.7 % ) and myristic ( 18.9 % ) acid were most common saturated fats in milk .
RESULTS	Four trans fatty acids constituted 3.7 % of the total milk fat content .
RESULTS	Increased dairy food intake by 3.0 ( 1.2 ) serves / day for 1month was associated with small increases in plasma levels of myristic ( +0.05 , 95 % confidence level-0 .08 to 0.13 , p = 0.07 ) , pentadecanoic ( +0.014 , 95 % confidence level -0.016 to 0.048 , p = 0.02 ) and margaric acid ( +0.02 , -0.03 to 0.05 , p = 0.03 ) .
RESULTS	There was no significant change in plasma levels of 4 saturated , 4 trans and 10 unsaturated fatty acids .
RESULTS	Decreasing dairy food intake by 2.5 ( 1.2 ) serves per day was not associated with change in levels of any plasma fatty acid levels .
CONCLUSIONS	Dietary advice to change dairy food has a minor effect on plasma fatty acid levels .
BACKGROUND	ACTRN12612000574842 .

###25112085
OBJECTIVE	To observe the clinical effects of essential hypertension treated with acupuncture at Siguan [ Hegu ( LI 4 ) and Taichong ( LR 3 ) ] , Quchi ( LI 11 ) and Xingjian ( LR 2 ) .
METHODS	Sixty cases of essential hypertension were randomly divided into an acupuncture group and a medication group , 30 cases in each group .
METHODS	Two groups of acupoint , which were ( 1 ) Siguan [ Hegu ( LI 4 ) and Taichong ( LR 3 ) ] and ( 2 ) Quchi ( LI 11 ) , Xingjian ( LR 2 ) , were selected alternatively in the acupuncture group , once everyday .
METHODS	In the medication group , captopril was prescribed for oral administration 25 mg per time , three times per day .
METHODS	Seven days made one session in both groups and totally three sessions were required .
RESULTS	( 1 ) After treatment , the blood pressure were decreased significantly in the two groups ( all P < 0.01 ) .
RESULTS	Compared with the medication group , the diastolic pressure after 14 days , 21 days of treatment in the acupuncture group was decreased significantly ( both P < 0.01 ) .
RESULTS	( 2 ) In the terms of TCM syndrome score , the improvement of dizziness , soreness and weakness of waist and knees , palpitations was significant in the acupuncture group compared with that in the medication group ( all P < 0.05 ) .
RESULTS	( 3 ) The acupuncture group had less adverse reactions compared with the control group ( P < 0.05 ) .
CONCLUSIONS	Acupuncture at Hegu ( LI4 ) and Taichong ( LR 3 ) , Quchi ( LI 11 ) and Xingjian ( LR 2 ) can effectively decrease blood pressure ; the effect of controlling diastolic pressure is better than captopril .
CONCLUSIONS	It can also improve the symptoms of dizziness , soreness and weakness of waist and knees , and palpitations .

###24588291
BACKGROUND	Although both researchers and practitioners widely recognize therapeutic alliance 's importance in general psychotherapy , studies specific to alcohol use treatments have produced mixed results and generally do not investigate if and how alliance changes over course of treatment .
METHODS	Using parallel process latent growth curve modeling , the authors examined if increase in alliance was associated with reduced drinking behaviors and a statistical mediator in the relationship between treatment modality and outcome .
METHODS	The authors used data from Project MATCH ( J Stud Alcohol .
METHODS	1997 ; 58:7 -29 ; Addiction .
METHODS	1997 ; 92:1671 -1698 ) , which investigated client-treatment matching effects for alcohol treatment among outpatient ( n = 952 ) and aftercare ( n = 774 ) participants randomized to cognitive behavioral treatment ( CBT ) , 12-step facilitation ( TSF ) , or motivational enhancement therapy ( MET ) .
RESULTS	Results indicate therapist-rated alliance increased significantly for CBT and TSF participants , but not MET .
RESULTS	Participants across modalities in both samples evidenced the largest decrease in drinking behaviors from baseline to midtreatment and a slight deterioration in treatment gains from midtreatment to 15 months posttreatment .
RESULTS	Alliance did not mediate the relationship between treatment modality and outcome , but increase in alliance was significantly related to decrease in drinking frequency .
CONCLUSIONS	These findings provide further justification for researchers to specifically design studies to examine change in alliance as a mechanism of change in alcohol treatments .

###25127417
OBJECTIVE	Although heterogeneity exists in patient outcomes following subarachnoid hemorrhage ( SAH ) across different centers and countries , it is unclear which factors contribute to such disparities .
OBJECTIVE	In this study , the authors performed a post hoc analysis of a large international database to evaluate the association between a country 's socioeconomic indicators and patient outcome following aneurysmal SAH .
METHODS	An analysis was performed on a database of 3552 patients enrolled in studies of tirilazad mesylate for aneurysmal SAH from 1991 to 1997 , which included 162 neurosurgical centers in North and Central America , Australia , Europe , and Africa .
METHODS	Two primary outcomes were assessed at 3 months after SAH : mortality and Glasgow Outcome Scale ( GOS ) score .
METHODS	The association between these outcomes , nation-level socioeconomic indicators ( percapita gross domestic product [ GDP ] , population-to-neurosurgeon ratio , and health care funding model ) , and patientlevel covariates were assessed using a hierarchical mixed-effects logistic regression analysis .
RESULTS	Multiple previously identified patient-level covariates were significantly associated with increased mortality and worse neurological outcome , including age , intraventricular hemorrhage , and initial neurological grade .
RESULTS	Among national-level covariates , higher per-capita GDP ( p < 0.05 ) was associated with both reduced mortality and improved neurological outcome .
RESULTS	A higher population-to-neurosurgeon ratio ( p < 0.01 ) , as well as fewer neurosurgical centers per population ( p < 0.001 ) , was also associated with better neurological outcome ( p < 0.01 ) .
RESULTS	Health care funding model was not a significant predictor of either primary outcome .
CONCLUSIONS	Higher per-capita gross GDP and population-to-neurosurgeon ratio were associated with improved outcome after aneurysmal SAH .
CONCLUSIONS	The former result may speak to the availability of resources , while the latter may be a reflection of better outcomes with centralized care .
CONCLUSIONS	Although patient clinical and radiographic phenotypes remain the primary predictors of outcome , this study shows that national socioeconomic disparities also explain heterogeneity in outcomes following SAH .

###24966099
OBJECTIVE	We aimed to compare the success rates of the double hydrodistention implantation technique ( HIT ) and the HIT with a polyacrylate/polyalcohol copolymer ( PPC ) for the treatment of primary vesicoureteral reflux ( VUR ) with a new nonbiodegradable tissue-augmenting substance ( Vantris , Promedon , Cordoba , Argentina ) .
METHODS	Between January 2011 and December 2012 , fifty-two children who underwent subureteric injection for primary VUR are included .
METHODS	The children were randomly separated into two groups , the HIT and the double HIT groups , according to the type of injection .
METHODS	Success was defined as no reflux on a follow-up voiding cystourethrogram ( VCUG ) after 6 months .
METHODS	The patients were evaluated according to sex , age , grade of reflux , number of injections , and injected volume , and the radiological success rates were compared .
RESULTS	Fifty-two patients underwent an endoscopic injection for primary grade III-V VUR .
RESULTS	The HIT group consisted of 26 patients with 33 ureters , and the double HIT group consisted of 26 patients with 35 ureters .
RESULTS	There were no significant differences in terms of the sex , ages , VUR grades , bilaterality between the two groups .
RESULTS	The mean injected volumes were ml 1.12 ( 1.02-1 .22 ) in the HIT group and 1.24 ml ( 95 % CI 1.10-1 .38 ) in the double HIT group .
RESULTS	The reflux was resolved in 21/33 ( 63.6 % ) ureters in the HIT group and in 30/35 ( 85.7 % ) ureters in the double HIT group , ( p < 0.05 ) .
RESULTS	We had only one complication .
RESULTS	This patient in the double HIT group , developed bilateral hydronephrosis and oliguric renal failure requiring open reimplantation at the sixth month .
CONCLUSIONS	We observed successful results double HIT method with PPC in Grade III-V reflux , but the long-term follow-up of patients is needed for hydronephrosis .
CONCLUSIONS	As the double HIT treatment leads to a higher success rate , its use is preferable .

###24773760
BACKGROUND	Glaucoma is a chronic eye disease associated with irreversible visual loss .
BACKGROUND	In Africa , glaucoma patients often present late , with very advanced disease .
BACKGROUND	One-off procedures , such as laser or surgery , are recommended in Africa because of lack of or poor adherence to medical treatment .
BACKGROUND	However , acceptance of surgery is usually extremely low .
BACKGROUND	To prevent blindness , adherence to treatment needs to improve , using acceptable , replicable and cost-effective interventions .
BACKGROUND	After reviewing the literature and interviewing patients in Bauchi ( Nigeria ) motivational interviewing ( MI ) was selected as the intervention for this trial , with adaptation for glaucoma ( MIG ) .
BACKGROUND	MI is designed to strengthen personal motivation for , and commitment to a specific goal by eliciting and exploring a person 's reasons for change within an atmosphere of acceptance and compassion .
BACKGROUND	The aim of this study is to assess whether MIG increases the uptake of laser or surgery amongst glaucoma patients where this is the recommended treatment .
BACKGROUND	The hypothesis is that MIG increases the uptake of treatment .
BACKGROUND	This will be the first trial of MI in Africa .
METHODS	This is a hospital based , single centre , randomized controlled trial of MIG plus an information sheet on glaucoma and its treatment ( the latter being `` standard care '' ) compared with standard care alone for glaucoma patients where the treatment recommended is surgery or laser.Those eligible for the trial are adults aged 17years and above who live within 200km of Bauchi with advanced glaucoma where the examining ophthalmologist recommends surgery or laser .
METHODS	After obtaining written informed consent , participants will be randomly allocated to MIG plus standard care , or standard care alone .
METHODS	Motivational interviewing will be delivered in Hausa or English by one of two MIG trained personnel .
METHODS	One hundred and fifty participants will be recruited to each arm .
METHODS	The primary outcome is the proportion of participants undergoing laser or surgery within two months of the date given to re attend for the procedure .
METHODS	MIG quality will be assessed using the validated MI treatment integrity scale .
CONCLUSIONS	Motivational interviewing may be an important tool to increase the acceptance of treatment for glaucoma .
CONCLUSIONS	The approach is potentially scalable and may be useful for other chronic conditions in Africa .
BACKGROUND	ISRCTN79330571 ( Controlled-Trials .
BACKGROUND	com ) .

###25742205
OBJECTIVE	To undertake a double-blind , randomized , placebo-controlled trial to examine the efficacy of acamprosate in maintaining complete abstinence in Japanese patients with alcohol dependence .
METHODS	We enrolled 327 patients with ICD-10-defined alcohol dependence and randomly assigned them to treatment with either acamprosate ( 1,998 mg/d orally ) or placebo for 24 weeks .
METHODS	The primary endpoint was complete abstinence after 24 weeks of administration .
METHODS	The study was performed at 34 medical institutions between 2009 and 2011 .
RESULTS	The acamprosate group demonstrated significantly superior efficacy versus the placebo group on the primary endpoint : the proportion maintaining complete abstinence in the acamprosate group was 47.2 % ( 77/163 subjects ) , compared with 36.0 % ( 59/164 subjects ) in the placebo group ( P = .039 ) .
RESULTS	The difference in complete abstinence rates between the 2 groups was 11.3 % ( 95 % CI , 0.6 % -21.9 % ) .
CONCLUSIONS	Acamprosate is superior to placebo in maintaining abstinence in Japanese patients with alcohol dependence .
CONCLUSIONS	These findings concur with 11 randomized , blinded , placebo-controlled clinical trials conducted in Europe .
CONCLUSIONS	This study was designed to reflect clinical practice in Japan and is therefore a meaningful addition to the available evidence in this field .
BACKGROUND	JapicCTI identifier : 090694 .

###24338058
OBJECTIVE	To investigate the use of neuromuscular electrical stimulation ( NMES ) during acute recovery between 2 bouts of maximal aerobic exercise .
METHODS	On 3 separate days , 19 trained male cyclists ( 28 7 y , 76.4 10.4 kg , power output at maximal aerobic power [ pVo2max ] 417 44 W ) performed a 3-min maximal cycling bout at 105 % PVo2max before a 30-min randomly assigned recovery intervention of passive ( PAS : resting ) , active ( ACT : 30 % PVo2max ) , or NMES ( 5 Hz , 4 pulses at 500 s ) .
METHODS	Immediately afterward , a cycle bout at 95 % PVo2max to exhaustion ( TLIM ) was performed .
METHODS	Heart rate ( HR ) and blood lactate ( BLa ) were recorded at designated time points .
METHODS	Data were analyzed using repeated-measures ANOVA with a Tukey honestly significantly different post hoc test .
METHODS	Statistical significance threshold was P < .05 .
RESULTS	The TLIM was significantly shorter for NMES than for ACT ( 199.6 69.4 s vs 250.7 105.5 s : P = .016 ) but not PAS recovery ( 199.6 69.4 s vs 216.4 77.5 s : P = .157 ) .
RESULTS	The TLIM was not significantly different between ACT and PAS ( 250.7 105.5 s vs 216.4 77.5 s : P = .088 ) .
RESULTS	The decline in BLa was significantly greater during ACT than NMES and PAS recovery ( P < .001 ) , with no difference between NMES and PAS .
RESULTS	In addition , HR was significantly higher during ACT than NMES and PAS recovery ( P < .001 ) , with no difference between NMES and PAS .
CONCLUSIONS	NMES was less effective than ACT and comparable to PAS recovery when used between 2 bouts of maximal aerobic exercise in trained male cyclists .

###25448628
BACKGROUND	The National Institute for Health and Care Excellence ( NICE ) guidelines for attention deficit/hyperactivity disorder ( ADHD ) state that young people need to have access to the best evidence-based care to improve outcome .
BACKGROUND	The current ` gold standard ' ADHD diagnostic assessment combines clinical observation with subjective parent , teacher and self-reports .
BACKGROUND	In routine practice , reports from multiple informants may be unavailable or contradictory , leading to diagnostic uncertainty and delay .
BACKGROUND	The addition of objective tests of attention and activity may help reduce diagnostic uncertainty and delays in initiating treatment leading to improved outcomes .
BACKGROUND	This trial investigates whether providing clinicians with an objective report of levels of attention , impulsivity and activity can lead to an earlier , and more accurate , clinical diagnosis and improved patient outcome .
METHODS	This multisite randomised controlled trial will recruit young people ( aged 6-17 years old ) who have been referred for an ADHD diagnostic assessment at Child and Adolescent Mental Health Services ( CAMHS ) and Community Paediatric clinics across England .
METHODS	Routine clinical assessment will be augmented by the QbTest , incorporating a continuous performance test ( CPT ) and infrared motion tracking of activity .
METHODS	The participant will be randomised into one of two study arms : QbOpen ( clinician has immediate access to a QbTest report ) : QbBlind ( report is withheld until the study end ) .
METHODS	Primary outcomes are time to diagnosis and diagnostic accuracy .
METHODS	Secondary outcomes include clinician 's diagnostic confidence and routine clinical outcome measures .
METHODS	Cost-effective analysis will be conducted , alongside a qualitative assessment of the feasibility and acceptability of incorporating QbTest in routine practice .
BACKGROUND	The findings from the study will inform commissioners , clinicians and managers about the feasibility , acceptability , clinical utility and cost-effectiveness of incorporating QbTest into routine diagnostic assessment of young people with ADHD .
BACKGROUND	The results will be submitted for publication in peer-reviewed journals .
BACKGROUND	The study has received ethical approval .
BACKGROUND	NCT02209116 .

###24225338
BACKGROUND	Studies have shown that repeated post-prandial hyperglycemia may play an important role in the development of atherosclerosis by suppressing endothelial function .
BACKGROUND	- Glucosidase inhibitors ( - GIs ) , which reduce post-prandial hyperglycemia without stimulating insulin secretion , significantly reduce the risk of coronary artery disease ( CAD ) , whereas glinides , which improve post-prandial hyperglycemia through post-prandial insulin secretion , do not appear to affect CAD .
RESULTS	A total of 104 diabetic patients with CAD were randomly divided into 2 groups : those treated with miglitol ( M-group ; n = 52 ) and those treated with nateglinide ( N-group ; n = 52 ) .
RESULTS	After 4 months ' treatment , although hemoglobin A1c and 1,5-anhydroglucitol were significantly improved in both groups , only the M-group had significant reductions in insulin resistance index and triglyceride/high-density lipoprotein cholesterol ( TG/HDL-C ; a beneficial index for assessing the presence of small dense low-density lipoprotein , and a marker of atherogenic dyslipidemia ) .
RESULTS	Furthermore , only the M-group had improvement in percentage flow-mediated dilatation ( % FMD ) and reactive oxygen metabolites .
RESULTS	In the M-group , multiple regression analysis showed that improvement in TG/HDL-C , in addition to 1,5-anhydroglucitol , was an independent predictor of improvement in % FMD .
CONCLUSIONS	The ameliorating effect of - GI on post-prandial hyperglycemia without stimulating insulin secretion may improve atherogenic dyslipidemia by reducing insulin resistance .
CONCLUSIONS	These effects are associated with its beneficial impact on oxidative stress , consequently leading to an improvement in endothelial dysfunction .

###25759972
OBJECTIVE	To evaluate three coronary artery calcification ( CAC ) scoring methods to assess risk of coronary heart disease ( CHD ) death and all-cause mortality in National Lung Screening Trial ( NLST ) participants across levels of CAC scores .
METHODS	The NLST was approved by the institutional review board at each participating institution , and informed consent was obtained from all participants .
METHODS	Image review was HIPAA compliant .
METHODS	Five cardiothoracic radiologists evaluated 1575 low-dose computed tomographic ( CT ) scans from three groups : 210 CHD deaths , 315 deaths not from CHD , and 1050 participants who were alive at conclusion of the trial .
METHODS	Radiologists used three scoring methods : overall visual assessment , segmented vessel-specific scoring , and Agatston scoring .
METHODS	Weighted Cox proportional hazards models were fit to evaluate the association between scoring methods and outcomes .
RESULTS	In multivariate analysis of time to CHD death , Agatston scores of 1-100 , 101-1000 , and greater than 1000 ( reference category 0 ) were associated with hazard ratios of 1.27 ( 95 % confidence interval : 0.69 , 2.53 ) , 3.57 ( 95 % confidence interval : 2.14 , 7.48 ) , and 6.63 ( 95 % confidence interval : 3.57 , 14.97 ) , respectively ; hazard ratios for summed segmented vessel-specific scores of 1-5 , 6-11 , and 12-30 ( reference category 0 ) were 1.72 ( 95 % confidence interval : 1.05 , 3.34 ) , 5.11 ( 95 % confidence interval : 2.92 , 10.94 ) , and 6.10 ( 95 % confidence interval : 3.19 , 14.05 ) , respectively ; and hazard ratios for overall visual assessment of mild , moderate , or heavy ( reference category none ) were 2.09 ( 95 % confidence interval : 1.30 , 4.16 ) , 3.86 ( 95 % confidence interval : 2.02 , 8.20 ) , and 6.95 ( 95 % confidence interval : 3.73 , 15.67 ) , respectively .
CONCLUSIONS	By using low-dose CT performed for lung cancer screening in older , heavy smokers , a simple visual assessment of CAC can be generated for risk assessment of CHD death and all-cause mortality , which is comparable to Agatston scoring and strongly associated with outcome .

###24810757
OBJECTIVE	Postoperative cognitive decline is common after cardiac surgery , but it is often unrecognized at the time of hospital discharge .
OBJECTIVE	However , it has a great impact on patient 's quality of life .
OBJECTIVE	Cerebral oximetry with the INVOS ( IN Vivo Optical Spectroscopy ) system provides the possibility of non-invasive , continuous measurement of regional cerebral oxygen saturation ( rSO2 ) , which can improve patients ' outcome .
OBJECTIVE	The aim of this study was to examine whether cerebral oximetry can decrease the incidence of cognitive decline after coronary artery bypass grafting .
METHODS	We have performed a prospective , randomized study with 200 patients enrolled .
METHODS	Patients were divided into INVOS interventional group and CONTROL group without monitoring of cerebral oximetry .
METHODS	A standardized interventional protocol was performed in the INVOS group to maintain rSO2 above 80 % of the patient 's baseline value or above 50 % of the absolute value .
METHODS	Cognitive evaluation was performed in all patients before and 7 days after surgery .
METHODS	Logistic regression was used to reveal predictors of cognitive decline .
RESULTS	The incidence of cognitive decline 7 days after surgery was significantly lower ( P = 0.002 ) in the INVOS interventional group ( 28 % ) than in the CONTROL group ( 52 % ) .
RESULTS	Intraoperative use of INVOS monitoring was associated with lower incidence of cognitive decline ( odds ratio 0.21 ) .
RESULTS	In addition , predictors of cognitive decline revealed by multivariate logistic regression were older age , higher EuroSCORE and SAPS II ( Simplified Acute Physiology Score ) values , lower educational level and persistence of preoperative atrial fibrillation .
RESULTS	Patients with prolonged rSO2 desaturation , defined as rSO2 area under the curve ( AUC ) of more than 150 min % for desaturation below 20 % of baseline or AUC of more than 50 min % for desaturation below 50 % absolute value , had an increased risk of cognitive decline .
CONCLUSIONS	Postoperative cognitive outcome was significantly better in patients with intraoperative cerebral oximetry monitoring .
CONCLUSIONS	Prolonged rSO2 desaturation is a predictor of cognitive decline and has to be avoided .

###24628830
OBJECTIVE	Clozapine is considered to be particularly effective in the treatment of dually diagnosed ( DD ) patients with psychosis and substance use disorders .
OBJECTIVE	However , its use is restricted by potentially severe side effects .
OBJECTIVE	The aim of the present pilot study was to compare the effects of clozapine with the newer second generation antipsychotic ( SGA ) ziprasidone in DD-patients .
METHODS	Thirty ( n = 30 ) patients with schizophrenia and cannabis abuse/dependence were randomized to ziprasidone or clozapine and were followed up for up to 12 months .
RESULTS	Cannabis use was reduced in both groups during follow-up .
RESULTS	Clozapine treatment was associated with less positive symptoms of schizophrenia , more side effects and poorer compliance with treatment .
CONCLUSIONS	Results from this small pilot RCT suggest beneficial effects of both clozapine and ziprasidone in the treatment of cannabis use disorders in psychotic patients .
CONCLUSIONS	Larger-scale RCTs are needed in order to assess advantages and disadvantages of the different SGAs in dually diagnosed populations .

###25347451
BACKGROUND	This study was part of a Phase 3 program treating crow 's feet lines ( CFL ) with onabotulinumtoxinA .
OBJECTIVE	To evaluate the efficacy and safety of onabotulinumtoxinA treatment of CFL .
METHODS	This multicenter , double-blind , placebo-controlled , 5-month study randomized subjects with moderate-to-severe CFL ( maximum smile ) to onabotulinumtoxinA ( 24 U ; n = 222 ) or placebo ( n = 223 ) .
METHODS	Investigators and subjects assessed CFL severity ( maximum smile and rest ) using the 4-grade Facial Wrinkle Scale ( FWS ) .
METHODS	Co-primary end points were investigator - and subject-assessed proportion of subjects achieving a CFL FWS grade of 0 ( none ) or 1 ( mild ) at maximum smile ( Day 30 ) .
METHODS	Additional efficacy end points , patient-reported outcomes , and safety/adverse events ( AEs ) were evaluated .
RESULTS	All primary and secondary end points were achieved ; statistically significant differences favored onabotulinumtoxinA ( p < .001 , all comparisons vs placebo ) .
RESULTS	Co-primary responder rates were 66.7 % compared with 6.7 % for investigator-assessed and 58.1 % compared with 5.4 % for subject-assessed response ( onabotulinumtoxinA group and placebo , respectively ; p < .001 ) .
RESULTS	A significantly greater proportion of the onabotulinumtoxinA group than placebo group achieved a 1 grade or greater improvement on the FWS ( maximum smile and rest assessed by both the investigator and subject ; all time points ; p < .001 ) .
RESULTS	Most AEs were mild or moderate and did not result in discontinuations .
CONCLUSIONS	Treatment of moderate-to-severe CFL with onabotulinumtoxinA was effective and well tolerated .

###25965709
BACKGROUND	p38 mitogen-activated protein kinase ( MAPK ) mediates cytokine production and amplification of the inflammatory cascade .
BACKGROUND	Through inhibition of p38 MAPK , losmapimod appears to attenuate the inflammatory response in the vascular wall and thus may help stabilize plaques .
METHODS	The LATITUDE-TIMI 60 trial is a randomized , double-blind , placebo-controlled , parallel-group , multicenter study planned to be conducted in a 3-stage design .
METHODS	Overall , the trial is designed to include 25,500 patients hospitalized with non-ST-elevation or ST-elevation myocardial infarction ( MI ) randomized to oral losmapimod ( 7.5 mg twice daily ) versus matching placebo .
METHODS	Part A consists of a leading cohort ( n = 3,500 ) that will provide an initial assessment of safety and exploratory efficacy before progressing to part B. Part B ( n = ~ 22,000 ) of the study is event driven and will provide the primary assessment of efficacy .
METHODS	An independent safety review will be conducted after 3,500 patients in part B1 to determine whether a more focused schedule of clinic visits and laboratory assessments can be implemented ( part B2 ) .
METHODS	All patients are to be treated with study drug until week 12 and followed up until week 24 .
METHODS	The primary end point is the composite of cardiovascular death , MI , or severe recurrent ischemia requiring urgent coronary revascularization .
METHODS	The key secondary end point is the composite of cardiovascular death or MI .
METHODS	The trial is designed to provide 90 % power for the primary end point .
CONCLUSIONS	The LATITUDE-TIMI 60 trial will determine the efficacy and safety of short-term p38 MAPK inhibition with losmapimod in acute MI .
CONCLUSIONS	The trial design adopts a stepwise approach to decision making and collection of data .

###24239600
BACKGROUND	Hyangaa-Pyeongwi san is the most well known description in Traditional Chinese Medicine for treating functional gastrointestinal disorders .
BACKGROUND	Functional dyspepsia ( FD ) is a main concern of intimidating quality of life ( QoL ) in recent days .
BACKGROUND	Although many medicines have been developed to improve FD symptoms as well as QoL , there are no potential drugs and treatments for FD .
BACKGROUND	The aim of this study is to investigate the effects of Hyangaa-Pyeongwi san ( HPS ) on QoL of patients with FD .
METHODS	This study was designed as a randomized , double blinded , placebo controlled , and parallel group trial .
METHODS	Participants received either placebo or HPS ( 9.68 g of HPS at once , three times daily ) for 4-weeks , and the efficacy evaluations were performed by assessing the Nepean Dyspepsia Index ( NDI ) and functional dyspepsia-quality of life ( FD-QoL ) at 0 - , 4 - and 8-weeks .
RESULTS	Total of 170 patients participated and were randomly allocated into placebo or HPS groups .
RESULTS	Total symptom score of NDI decreased after 4-weeks trial in both groups ( p > 0.05 ) .
RESULTS	HPS significantly improved QoL scores , especially in the area of ` interference and eat/drink ' in NDI ( p = 0.0031 ) as well as ` liveliness status ' , ` role-functioning status ' , and total score in FD-QoL ( p = 0.026 for liveliness status and p = 0.035 for role-functioning status ) .
RESULTS	This significant improvement of FD-QoL had lasted for 4-weeks .
CONCLUSIONS	HPS treatment is markedly effective in improving QoL in patients with FD .
CONCLUSIONS	Moreover , we observed that this improvement had lasted for 4 weeks after finishing the trial through the follow-up study .

###25105787
OBJECTIVE	The aim of the study was to compare two surgical methods of treating diaphyseal fractures of the humerus .
METHODS	A prospective randomised study on the surgical treatment of humeral diaphyseal fractures was carried out between September 2009 and January 2013 .
METHODS	The patients indicated for surgical treatment fell into two groups according to the technique used as follows : minimally invasive plate osteosynthesis ( MIPO ) with a locking compression plate ( LCP ; Synthes , Switzerland ) ; depending on the fracture type and course of fracture line , either a straight narrow or a Philos or a metaphyseal LCP was used ( group 1 ) ; and intramedullary nailing ( EHN , Synthes , Switzerland ) ( group 2 ) .
METHODS	A total of 49 patients were entered into the study .
METHODS	The men-to-women ratio was about 1:1 and the average age was 52 years ( 18 to 83 ) .
METHODS	Of them , 45 patients with 46 humeral fractures were followed up and evaluated .
METHODS	The injury was caused by a fall from standing or while walking ( n = 21 ) , traffic accident ( n = 16 ) , sports activity ( n = 3 ) or work-related activity ( n = 5 ) .
METHODS	A single injury was treated in 72 % and multiple trauma in 28 % of the patients .
METHODS	Using the AO classification , fractures were diagnosed as types A , B and C in 25 , 10 and 11 patients , respectively .
METHODS	The patients were randomised into the groups using a computer programme allowing for the maintenance of group homogeneity .
METHODS	Each patient received information on the method to be used in a sealed envelope .
RESULTS	The average injury-surgery interval was 6 days ( range , 0 to 26 ) .
RESULTS	The average operative time was 128 minutes ( 80 to 200 ) .
RESULTS	The average intra-operative exposure to X-ray was 8 minutes ( 3 to 20 ) .
RESULTS	The average hospital stay was 20 days ( 4 to 100 ) The average rehabilitation time till functional recovery was 17 weeks ( 3 to 37 ) , the time of bone union by radiographic assessment was 20 weeks ( 12 to 40 ) .
RESULTS	The functional outcome was assessed using the Constant-Murley ( CM ) and Liverpool Elbow Score ( LES ) systems .
RESULTS	The relative CM/LES score , as compared with the healthy extremity , was 95/100 .
RESULTS	Excellent and good results were achieved in 89 % and complications were recorded in 26 % of the patients .
RESULTS	The most frequent complication was impingement syndrome or prolonged rehabilitation both in the patients with proximal humerus fractures managed with the Philos locking plate and in those treated by intramedullary nailing , although this was not necessarily due to a technical error , i.e. , osteosynthetic material protrusion .
RESULTS	Iatrogenic radial nerve injury was found only in one patient treated by intramedullary nailing and was associated with traction during reduction and nail insertion .
RESULTS	Pseudoarthrosis was recorded in one patient of each group and there were no infectious complications .
CONCLUSIONS	Intramedullary nailing has not yet shown such good outcomes in humeral as in tibial fractures .
CONCLUSIONS	The results of metaanalysis have indicated that humeral fractures treated by plate osteosynthesis have fewer complications and require repeat surgery less frequently .
CONCLUSIONS	However , as shown by most recent studies , this difference is getting smaller .
CONCLUSIONS	The MIPO technique was adopted at our department several years ago and the aim was to compare our results with those of other centres .
CONCLUSIONS	The studies so far published have show that MIPO and conventional open plate osteosynthesis give comparable outcomes .
CONCLUSIONS	CONCLUSIONS The statistical evaluation using the unpaired t-test did not show any significant differences in either the functional results or the number of complications between the two methods .
CONCLUSIONS	Both achieved about 90 % of excellent and good results and had 26 % of complications .
CONCLUSIONS	The only significant difference was found in the length of operative time ( 136 min in MIPO versus 117 min in EHN ) .
CONCLUSIONS	With use of the Chi-Square test , a significant correlation between AO fracture type and treatment outcome in the MIPO group was found , i.e. , no poor result was recorded for type A fractures , as assessed by the CM/LES score .
CONCLUSIONS	No such correlation between the fracture type and the functional outcome was seen in the EHN group .

###24352377
OBJECTIVE	Sociocommunicational deficits make it difficult for individuals with autism spectrum disorders ( ASD ) to understand communication content with conflicting verbal and nonverbal information .
OBJECTIVE	Despite growing prospects for oxytocin as a therapeutic agent for ASD , no direct neurobiological evidence exists for oxytocin 's beneficial effects on this core symptom of ASD .
OBJECTIVE	This is slowing clinical application of the neuropeptide .
OBJECTIVE	To directly examine whether oxytocin has beneficial effects on the sociocommunicational deficits of ASD using both behavioral and neural measures .
METHODS	At the University of Tokyo Hospital , we conducted a randomized , double-blind , placebo-controlled , within-subject-crossover , single-site experimental trial in which intranasal oxytocin and placebo were administered .
METHODS	A total of 40 highly functioning men with ASD participated and were randomized in the trial .
METHODS	Single-dose intranasal administration of oxytocin ( 24 IU ) and placebo .
METHODS	Using functional magnetic resonance imaging , we examined effects of oxytocin on behavioral neural responses of the participants to a social psychological task .
METHODS	In our previous case-control study using the same psychological task , when making decisions about social information with conflicting verbal and nonverbal contents , participants with ASD made judgments based on nonverbal contents less frequently with longer time and could not induce enough activation in the medial prefrontal cortex .
METHODS	Therefore , our main outcomes and measures were the frequency of the nonverbal information-based judgments ( NVJs ) , the response time for NVJs , and brain activity of the medial prefrontal cortex during NVJs .
RESULTS	Intranasal oxytocin enabled the participants to make NVJs more frequently ( P = .03 ) with shorter response time ( P = .02 ) .
RESULTS	During the mitigated behavior , oxytocin increased the originally diminished brain activity in the medial prefrontal cortex ( P < .001 ) .
RESULTS	Moreover , oxytocin enhanced functional coordination in the area ( P < .001 ) , and the magnitude of these neural effects was predictive of the behavioral effects ( P .01 ) .
CONCLUSIONS	These findings provide the first neurobiological evidence for oxytocin 's beneficial effects on sociocommunicational deficits of ASD and give us the initial account for neurobiological mechanisms underlying any beneficial effects of the neuropeptide .
BACKGROUND	umin.ac.jp / ctr Identifier : UMIN000002241 and UMIN000004393 .

###24916837
BACKGROUND	Studies suggest that both affective and cognitive processes are involved in the perception of vulnerability to cancer and that affect has an early influence in this assessment of risk .
BACKGROUND	We constructed a path model based on a conceptual framework of heuristic reasoning ( affect , resemblance , and availability ) coupled with cognitive processes involved in developing personal models of cancer causation .
METHODS	From an eligible cohort of 16700 women in a managed care organization , we randomly selected 2524 women at high , elevated , and average risk of ovarian cancer and administered a questionnaire to test our model ( response rate 76.3 % ) .
METHODS	Path analysis delineated the relationships between personal and cognitive characteristics ( number of relatives with cancer , age , ideas about cancer causation , perceived resemblance to an affected friend or relative , and ovarian cancer knowledge ) and emotional constructs ( closeness to an affected relative or friend , time spent processing the cancer experience , and cancer worry ) on perceived risk of ovarian cancer .
RESULTS	Our final model fit the data well ( root mean square error of approximation ( RMSEA ) = 0.028 , comparative fit index ( CFI ) = 0.99 , normed fit index ( NFI ) = 0.98 ) .
RESULTS	This final model ( 1 ) demonstrated the nature and direction of relationships between cognitive characteristics and perceived risk ; ( 2 ) showed that time spent processing the cancer experience was associated with cancer worry ; and ( 3 ) showed that cancer worry moderately influenced perceived risk .
CONCLUSIONS	Our results highlight the important role that family cancer experience has on cancer worry and shows how cancer experience translates into personal risk perceptions .
CONCLUSIONS	This understanding informs the discordance between medical or objective risk assessment and personal risk assessment .
CONCLUSIONS	Published in 2014 .
CONCLUSIONS	This article is a U.S. Government work and is in the public domain in the USA .

###25361552
BACKGROUND	Knowledge of mitral valve prolapse ( MVP ) inheritance is based on pedigree observation and M-mode echocardiography .
BACKGROUND	The extent of familial clustering of MVP among unselected individuals in the community using current , more specific echocardiographic criteria is unknown .
BACKGROUND	In addition , the importance of nondiagnostic MVP morphologies ( NDMs ; first described in large pedigrees ) has not been investigated in the general population .
BACKGROUND	We hypothesized that parental MVP and NDMs increase the risk of offspring MVP .
RESULTS	Study participants were 3679 Generation 3 individuals with available parental data in the Offspring or the New Offspring Spouse cohorts .
RESULTS	MVP and NDMs were distinguished by leaflet displacement > 2 versus 2 mm beyond the mitral annulus , respectively .
RESULTS	We compared MVP prevalence in Generation 3 participants with at least 1 parent with MVP ( n = 186 ) with that in individuals without parental MVP ( n = 3493 ) .
RESULTS	Among 3679 participants ( 53 % women ; mean age , 409 years ) , 49 ( 1 % ) had MVP .
RESULTS	Parental MVP was associated with a higher prevalence of MVP in Generation 3 participants ( 10 of 186 , 5.4 % ) compared with no parental MVP ( 39 of 3493 , 1.1 % ; adjusted odds ratio , 4.51 ; 95 % confidence interval , 2.13-9 .54 ; P < 0.0001 ) .
RESULTS	When parental NDMs were examined alone , the prevalence of Generation 3 MVP remained higher ( 12 of 484 , 2.5 % ) compared with those without parental MVP or NDMs ( 27 of 3009 , 0.9 % ; adjusted odds ratio , 2.52 ; 95 % confidence interval , 1.25-5 .10 ; P = 0.01 ) .
CONCLUSIONS	Parental MVP and NDMs are associated with increased prevalence of offspring MVP , highlighting the genetic substrate of MVP and the potential clinical significance of NDMs in the community .

###24885005
BACKGROUND	Oral presentations of clinical cases by medical students during medical rounds in hospital wards are a source of anxiety and little is known about how this anxiety can be alleviated .
BACKGROUND	The objective of this study was to investigate whether video-based feedback of public oral presentations can reduce anxiety in 4th year medical students .
METHODS	Multicentre randomized study conducted in six intensive care units ( ICU ) and emergency departments ( ED ) in France over a 9-month period in 2012 .
METHODS	One hundred and forty two 4th year medical students were randomized to two groups : intervention and control .
METHODS	Students in the intervention group were recorded while making an oral presentation of a patient during morning ward rounds , followed by video-based feedback .
METHODS	Students in the control group conducted presented classical oral presentations without being filmed and with no formal feedback .
METHODS	Anxiety levels during a public oral presentation were assessed using the Spielberger State Anxiety Inventory ( STAI-S ) .
METHODS	The primary outcome was the difference in STAI-S scores between groups at the beginning and at the end of a 3-month ICU or ED internship .
RESULTS	Seventy four students were randomized to the ` video-based feedback ' group and 68 were randomized to the control group .
RESULTS	In both groups , STAI-S scores were significantly lower after 3 months of internship .
RESULTS	However , the reduction in STAI-S scores was significantly greater in the `` video-based feedback '' group than in controls ( -9.29.3 vs. -4.68.2 , p = 0.024 .
RESULTS	Compared to the control group , significantly fewer students with high-level anxiety were observed in the `` video-based feedback '' group after 3 months of internship ( 68 vs. 28 % , p < 0.001 ) .
CONCLUSIONS	Compared to `` usual practice '' , video-assisted oral feedback reduced anxiety and significantly decreased the proportion of students experiencing severe anxiety .

###24709926
OBJECTIVE	To test Stepping Stones Triple P ( SSTP ) and Acceptance and Commitment Therapy ( ACT ) in a trial targeting behavioral problems in children with cerebral palsy ( CP ) .
METHODS	Sixty-seven parents ( 97.0 % mothers ; mean age 38.7 7.1 years ) of children ( 64.2 % boys ; mean age 5.3 3.0 years ) with CP ( Gross Motor Function Classification System = 15 , 22 % ; II = 18 , 27 % ; III = 12 , 18 % ; IV = 18 , 27 % ; V = 4 , 6 % ) participated and were randomly assigned to SSTP , SSTP + ACT , or waitlist .
METHODS	Primary outcomes were behavioral and emotional problems ( Eyberg Child Behavior Inventory [ ECBI ] , Strengths and Difficulties Questionnaire [ SDQ ] ) and parenting style ( Parenting Scale [ PS ] ) at postintervention and 6-month follow-up .
RESULTS	SSTP with ACT was associated with decreased behavioral problems ( ECBI Intensity mean difference [ MD ] = 24.12 , confidence interval [ CI ] 10.22 to 38.03 , P = .003 ; ECBI problem MD = 8.30 , CI 4.63 to 11.97 , P < .0001 ) including hyperactivity ( SDQ MD = 1.66 , CI 0.55 to 2.77 , P = .004 ) , as well as decreased parental overreactivity ( PS MD = 0.60 , CI 0.16 to 1.04 , P = .008 ) and verbosity ( PS MD = 0.68 , CI 0.17 to 1.20 , P = .01 ) .
RESULTS	SSTP alone was associated with decreased behavioral problems ( ECBI problems MD = 6.04 , CI 2.20 to 9.89 , P = .003 ) and emotional symptoms ( SDQ MD = 1.33 , CI 0.45 to 2.21 , P = .004 ) .
RESULTS	Decreases in behavioral and emotional problems were maintained at follow-up .
CONCLUSIONS	SSTP is an effective intervention for behavioral problems in children with CP .
CONCLUSIONS	ACT delivers additive benefits .

###25554820
BACKGROUND	Extremely preterm infants are at risk for neurodevelopmental impairment ( NDI ) .
BACKGROUND	Early cranial ultrasound ( CUS ) is usual practice , but near-term brain MRI has been reported to better predict outcomes .
BACKGROUND	We prospectively evaluated MRI white matter abnormality ( WMA ) and cerebellar lesions , and serial CUS adverse findings as predictors of outcomes at 18 to 22 months ' corrected age .
METHODS	Early and late CUS , and brain MRI were read by masked central readers , in a large cohort ( n = 480 ) of infants < 28 weeks ' gestation surviving to near term in the Neonatal Research Network .
METHODS	Outcomes included NDI or death after neuroimaging , and significant gross motor impairment or death , with NDI defined as cognitive composite score < 70 , significant gross motor impairment , and severe hearing or visual impairment .
METHODS	Multivariable models evaluated the relative predictive value of neuroimaging while controlling for other factors .
RESULTS	Of 480 infants , 15 died and 20 were lost .
RESULTS	Increasing severity of WMA and significant cerebellar lesions on MRI were associated with adverse outcomes .
RESULTS	Cerebellar lesions were rarely identified by CUS .
RESULTS	In full multivariable models , both late CUS and MRI , but not early CUS , remained independently associated with NDI or death ( MRI cerebellar lesions : odds ratio , 3.0 [ 95 % confidence interval : 1.3-6 .8 ] ; late CUS : odds ratio , 9.8 [ 95 % confidence interval : 2.8-35 ] ) , and significant gross motor impairment or death .
RESULTS	In models that did not include late CUS , MRI moderate-severe WMA was independently associated with adverse outcomes .
CONCLUSIONS	Both late CUS and near-term MRI abnormalities were associated with outcomes , independent of early CUS and other factors , underscoring the relative prognostic value of near-term neuroimaging .

###24901918
OBJECTIVE	The aim of this study was to assess the functional results of an early onset progressive eccentric and concentric training in patients with autogen hamstring anterior cruciate ligament ( ACL ) reconstruction .
METHODS	Thirty-three patients with autogenous hamstring ACL reconstruction were randomly divided into study ( n = 16 , mean age ; 33.878.19 ) and control ( n = 17 , mean age ; 32.648.21 ) groups and followed the same ACL rehabilitation program .
METHODS	Additionally , the study group followed a progressive eccentric and concentric training for 12 weeks on the Monitorized Functional Squat System ( MFSS ) beginning 3 weeks after surgery .
METHODS	The groups were compared according to the isokinetic strength of the knee extensors and flexors , functional performance ( the vertical jump test , a single hop for distance test ) and the Lysholm knee scale , the Anterior Cruciate Ligament-Quality of Life Questionnaire ( ACL-QOL ) , before and 16 weeks after the surgery .
RESULTS	The functional outcomes in terms of the vertical jump test ( p = 0.012 ) , a single hop-for-distance test ( p = 0.027 ) , the Lysholm knee scale ( p = 0.002 ) and the ACL-QOL questionnaire ( p = 0.000 ) demonstrated significantly greater improvement in the study group .
RESULTS	No significant difference was reported between groups for isokinetic strength of the knee extensors and flexors ( p > 0.05 ) .
CONCLUSIONS	Adding progressive eccentric and concentric exercises to the standard rehabilitation protocol may improve the functional results after ACL reconstruction with autogen hamstring grafts .

###24277400
OBJECTIVE	To evaluate safety and efficacy of preoperative administration of enteral nutrition support in gastric cancer patients at risk of malnutrition .
METHODS	A single center randomized controlled clinical trial was performed in 60 gastric cancer patients in West China Hospital from May to October 2012 .
METHODS	Thirty patients were given enteral nutrition support ( Ensure ( R ) ) manufactured by Abbott Laboratories for ten consecutive days before surgical operation in the treatment group , and 30 patients were given an isocaloric and isonitrogenous homogenized diet in the control group for 10 days as well .
METHODS	The laboratory parameters of nutritional status and hepatorenal function were observed and compared between the two groups on admission , preoperative day 1 and postoperative day 3 , respectively .
METHODS	Clinical observations , such as nausea and vomiting , were carried out until patients were discharged .
RESULTS	Before the intervention , there were no significant differences in the baseline characteristics between the two groups .
RESULTS	The levels of serum albumin [ ( 33.95.6 ) g/L vs. ( 31.05.3 ) g/L , P < 0.05 ] , and hemoglobin [ ( 103.47.7 ) g/L vs. ( 96.610.5 ) g/L , P < 0.01 ] were significantly improved in the treatment group on postoperative day 3 .
RESULTS	However , the levels of body mass index , lymphocyte count , liver and renal function , serum glucose , sodium , and potassium were not significantly different between the two groups ( all P > 0.05 ) .
RESULTS	Moreover , two patients with nausea and one with vomiting in each group were found .
RESULTS	In clinical observation period , no severe treatment-related adverse event were observed .
CONCLUSIONS	The enteral supplement with Ensure ( R ) in gastric cancer patients at risk of malnutrition during preoperative period is effective and safe , which is superior to homogenized diet and an appropriate choice for gastric cancer patients with nutritional risk .

###24779961
BACKGROUND	Inflammation may play an important role in type 2 diabetes .
BACKGROUND	It has been proposed that dietary strategies can modulate inflammatory activity .
METHODS	We investigated the effects of diet on inflammation in type 2 diabetes by comparing a traditional low-fat diet ( LFD ) with a low-carbohydrate diet ( LCD ) .
METHODS	Patients with type 2 diabetes were randomized to follow either LFD aiming for 55-60 energy per cent ( E % ) from carbohydrates ( n = 30 ) or LCD aiming for 20 E % from carbohydrates ( n = 29 ) .
METHODS	Plasma was collected at baseline and after 6 months .
METHODS	C-reactive protein ( CRP ) , interleukin-1 receptor antagonist ( IL-1Ra ) , IL-6 , tumour necrosis factor receptor ( TNFR ) 1 and TNFR2 were determined .
RESULTS	Both LFD and LCD led to similar reductions in body weight , while beneficial effects on glycaemic control were observed in the LCD group only .
RESULTS	After 6 months , the levels of IL-1Ra and IL-6 were significantly lower in the LCD group than in the LFD group , 978 ( 664-1385 ) versus 1216 ( 974-1822 ) pg/mL and 2.15 ( 1.65-4 .27 ) versus 3.39 ( 2.25-4 .79 ) pg/mL , both P < 0.05 .
CONCLUSIONS	To conclude , advice to follow LCD or LFD had similar effects on weight reduction while effects on inflammation differed .
CONCLUSIONS	Only LCD was found significantly to improve the subclinical inflammatory state in type 2 diabetes .

###25469044
OBJECTIVE	To investigate the safety/efficacy of Boceprevir-based triple therapy in hepatitis C virus ( HCV ) - G1 menopausal women who were historic relapsers , partial-responders and null-responders .
METHODS	In this single-assignment , unblinded study , we treated fifty-six menopausal women with HCV-G1 , 46 % F3-F4 , and previous PEG - / RBV failure ( 7 % null , 41 % non-responder , and 52 % relapser ) with 4 wk lead-in with PEG-IFN2b / RBV followed by PEG-IFN2b / RBV+B oceprevir for 32 wk , with an additional 12 wk of PEG-IFN -- 2b/RBV if patients were HCV-RNA-positive by week 8 .
METHODS	In previous null-responders , 44 wk of triple therapy was used .
METHODS	The primary objective of retreatment was to verify whether a sustained virological response ( SVR ) ( HCV RNA undetectable at 24 wk of follow-up ) rate of at least 20 % could be obtained .
METHODS	The secondary objective was the evaluation of the percent of patients with negative HCV RNA at week 4 ( RVR ) , 8 ( RVR BOC ) , 12 ( EVR ) , or at the end-of-treatment ( ETR ) that reached SVR .
METHODS	To assess the relationship between SVR and clinical and biochemical parameters , multiple logistic regression analysis was used .
RESULTS	After lead-in , only two patients had RVR ; HCV-RNA was unchanged in all but 62 % who had 1 log10 decrease .
RESULTS	After Boceprevir , HCV RNA became undetectable at week 8 in 32/56 ( 57.1 % ) and at week 12 in 41/56 ( 73.2 % ) .
RESULTS	Of these , 53.8 % and 52.0 % , respectively , achieved SVR .
RESULTS	Overall , SVR was obtained in 25/56 ( 44.6 % ) .
RESULTS	SVR was achieved in 55 % previous relapsers vs. 41 % non-responders ( P = 0.250 ) , in 44 % F0-F2 vs 54 % F3-F4 ( P = 0.488 ) , and in 11/19 ( 57.9 % ) of patients with cirrhosis .
RESULTS	At univariate analysis for baseline predictors of SVR , only previous response to antiviral therapy ( OR = 2.662 , 95 % CI : 0.957-6 .881 , P = 0.043 ) , was related with SVR .
RESULTS	When considering `` on treatment '' factors , 1 log10 HCV RNA decline at week 4 ( 3.733 , 95 % CI : 1.676-12 .658 , P = 0.034 ) and achievement of RVR BOC ( 7.347 , 95 % CI : 2.156-25 .035 , P = 0.001 ) were significantly related with the SVR , although RVR BOC only ( 6.794 , 95 % CI : 1.596-21 .644 , P = 0.010 ) maintained significance at multivariate logistic regression analysis .
RESULTS	Anemia and neutropenia were managed with Erythropoietin and Filgrastim supplementation , respectively .
RESULTS	Only six patients discontinued therapy .
CONCLUSIONS	Boceprevir obtained high SVR response independent of previous response , RVR or baseline fibrosis or cirrhosis .
CONCLUSIONS	RVR BOC was the only independent predictor of SVR .

###24553973
OBJECTIVE	To compare the efficacy of oral Montelukast and inhaled Budesonide as a first line preventive therapy in mild persistent asthma in age group 2-18 y.
METHODS	This prospective randomized controlled clinical study was conducted for 12 wk .
METHODS	Sixty patients of mild persistent asthma aged 2 to 18 y were randomly allocated to either oral Montelukast ( n = 60 ) or inhaled Budesonide ( n = 60 ) group .
METHODS	Outcomes measured were improvement in peak expiratory flow rate ( PEFR ) , forced expiratory volume 1s/forced vital capacity ( FEV1/FVC ) , day time and night time symptoms and frequency of exacerbations and need to change medications .
RESULTS	There was significant improvement in PEFR , FEV1/FVC , day time and night time symptoms and frequency of exacerbations in both groups .
RESULTS	However , more significant improvement in FEV1/FVC ( CI 95 % , p = 0.029 ) and day time symptoms ( CI 95 % , p = 0.002 ) was seen in Budesonide group compared to Montelukast group .
CONCLUSIONS	The present study suggests that oral Montelukast is not inferior to Budesonide in treatment of mild persistent asthma in 2 to 18 y children in terms of control of symptoms and improvement in pulmonary function tests over a 12 wk period .
CONCLUSIONS	However , there was more significant improvement in day time symptoms , more significant increase in FEV1/FVC ratio and less exacerbation in patients receiving Budesonide compared to those receiving Montelukast .
CONCLUSIONS	However , side effects due to long term use of steroids such as growth stunting and bone osteopenia should also be considered before recommending .
CONCLUSIONS	Trial registered at CTRI no .
CONCLUSIONS	REF/2012/09 / 004035 .

###25140957
BACKGROUND	Respiratory syncytial virus ( RSV ) is a common cause of infant hospitalizations and is increasingly recognized as a cause of considerable morbidity and mortality .
BACKGROUND	No accepted antiviral treatment exists .
METHODS	We conducted a double-blind , placebo-controlled study of GS-5806 , an oral RSV-entry inhibitor , in healthy adults who received a clinical challenge strain of RSV intranasally .
METHODS	Participants were monitored for 12 days .
METHODS	At the time of a positive test for RSV infection or 5 days after inoculation , whichever occurred first , participants were randomly assigned to receive GS-5806 or placebo in one of seven sequential cohorts .
METHODS	Cohorts 1 to 4 received a first dose of 50 mg of GS-5806 and then 25 mg daily for the next 4 days , cohort 5 received a first dose of 50 mg and then 25 mg daily for the next 2 days , cohort 6 received one 100-mg dose , and cohort 7 received a first dose of 10 mg and then 5 mg daily for the next 4 days .
METHODS	Dose selection for cohorts 5 , 6 , and 7 occurred after an interim analysis of data for cohorts 1 to 4 .
METHODS	The primary end point was the area under the curve ( AUC ) for the viral load , which was assessed after administration of the first dose through the 12th day after inoculation .
METHODS	Secondary end points were mucus weight and symptom scores .
RESULTS	Among the 54 participants in cohorts 1 to 4 who were infected with RSV , active treatment was associated with a lower viral load ( adjusted mean , 250.7 vs. 757.7 log10 plaque-forming-unit equivalents [ PFUe ] hours per milliliter ; P < 0.001 ) , lower total mucus weight ( mean , 6.9 g vs. 15.1 g ; P = 0.03 ) , and a lower AUC for the change from baseline in symptom scores ( adjusted mean , -20.2 vs. 204.9 hours ; P = 0.005 ) .
RESULTS	The results were similar in cohorts 5 , 6 , and 7 .
RESULTS	Adverse events , including low neutrophil counts and increased levels of alanine aminotransferase , were more common among participants receiving GS-5806 .
CONCLUSIONS	Treatment with GS-5806 reduced the viral load and the severity of clinical disease in a challenge study of healthy adults .
CONCLUSIONS	( Funded by Gilead Sciences ; ClinicalTrials.gov number , NCT01756482 . )

###24779384
BACKGROUND	Systematic reporting of funding sources is recommended in the CONSORT Statement for abstracts .
BACKGROUND	However , no specific recommendation is related to the reporting of conflicts of interest ( CoI ) .
BACKGROUND	The objective was to compare physicians ' confidence in the conclusions of abstracts of randomized controlled trials of pharmaceutical treatment indexed in PubMed .
METHODS	We planned a three-arm parallel-group randomized trial .
METHODS	French general practitioners ( GPs ) were invited to participate and were blinded to the study 's aim .
METHODS	We used a representative sample of 75 abstracts of pharmaceutical industry-funded randomized controlled trials published in 2010 and indexed in PubMed .
METHODS	Each abstract was standardized and reported in three formats : 1 ) no mention of the funding source or CoI ; 2 ) reporting the funding source only ; and 3 ) reporting the funding source and CoI .
METHODS	GPs were randomized according to a computerized randomization on a secure Internet system at a 1:1:1 ratio to assess one abstract among the three formats .
METHODS	The primary outcome was GPs ' confidence in the abstract conclusions ( 0 , not at all , to 10 , completely confident ) .
METHODS	The study was planned to detect a large difference with an effect size of 0.5 .
RESULTS	Between October 2012 and June 2013 , among 605 GPs contacted , 354 were randomized , 118 for each type of abstract .
RESULTS	The mean difference ( 95 % confidence interval ) in GPs ' confidence in abstract findings was 0.2 ( -0.6 ; 1.0 ) ( P = 0.84 ) for abstracts reporting the funding source only versus no funding source or CoI ; -0.4 ( -1.3 ; 0.4 ) ( P = 0.39 ) for abstracts reporting the funding source and CoI versus no funding source and CoI ; and -0.6 ( -1.5 ; 0.2 ) ( P = 0.15 ) for abstracts reporting the funding source and CoI versus the funding source only .
CONCLUSIONS	We found no evidence of a large impact of trial report abstracts mentioning funding sources or CoI on GPs ' confidence in the conclusions of the abstracts .
BACKGROUND	ClinicalTrials.gov identifier : NCT01679873 .

###24646327
BACKGROUND	Extended systemic lymphadenectomy ( D2 ) is standard procedure for surgical treatment of advanced gastric cancer ( AGC ) although less extensive lymphadenectomy ( D1 ) can be applied to early gastric cancer .
BACKGROUND	Complete D2 lymphadenectomy is the mandatory procedure for studies that evaluate surgical treatment results of AGC .
BACKGROUND	However , the actual extent of D2 lymphadenectomy varies among surgeons because of a lacking consensus on the anatomical definition of each lymph node station .
BACKGROUND	This study is aimed to develop a consensus for D2 lymphadenectomy and also to qualify surgeons that can perform both laparoscopic and open D2 gastrectomy .
METHODS	This ( KLASS-02-QC ) is a prospective , observational , multicenter study to qualify the surgeons that will participate in the KLASS-02-RCT , which is a prospective , randomized , clinical trial comparing laparoscopic and open gastrectomy for AGC .
METHODS	Surgeons and reviewers participating in the study will be required to complete a questionnaire detailing their professional experience and specific gastrectomy surgical background/training , and the gastrectomy metrics of their primary hospitals .
METHODS	All surgeons must submit three laparoscopic and three open D2 gastrectomy videos , respectively .
METHODS	Each video will be allocated to five peer reviewers ; thus each surgeon 's operations will be assessed by a total of 30 reviews .
METHODS	Based on blinded assessment of unedited videos by experts ' review , a separate review evaluation committee will decide whether or not the evaluated surgeon will participate in the KLASS-02-RCT .
METHODS	The primary outcome measure is each surgeon 's proficiency , as assessed by the reviewers based on evaluation criteria for completeness of D2 lymphadenectomy .
CONCLUSIONS	We believe that our study for standardization of D2 lymphadenectomy and surgical quality control ( KLASS-02-QC ) will guarantee successful implementation of the subsequent KLASS-02-RCT study .
CONCLUSIONS	After making consensus on D2 lymphadenectomy , we developed evaluation criteria for completeness of D2 lymphadenectomy .
CONCLUSIONS	We also developed a unique surgical standardization and quality control system that consists of recording unedited surgical videos , and expert review according to evaluation criteria for completeness of D2 lymphadenectomy .
CONCLUSIONS	We hope our systematic approach will set a milestone in surgical standardization that is essential for surgical clinical trials .
CONCLUSIONS	Additionally , our methods will serve as a novel system for educating surgeons and assessing surgical proficiency .
BACKGROUND	NCT01283893 .

###25293882
BACKGROUND	Approximately 30 % of HIV-1-infected patients receiving antiretroviral therapy who achieve virologic control have unsatisfactory immune reconstitution , with CD4 + T-cell counts persistently below 350 cells/L .
BACKGROUND	These patients are at elevated risk for clinical progression to AIDS and non-AIDS events .
BACKGROUND	CD4 + T-cell depletion following infection and persistent immune activation can partially explain this low CD4 + T-cell recovery .
BACKGROUND	Recent data suggest a link between the tryptophan oxidation pathway , immune activation and HIV disease progression based on overstimulation of the tryptophan oxidation pathway by HIV antigens and by interferon-gamma .
BACKGROUND	This overstimulation reduces levels of circulating tryptophan , resulting in inflammation which has been implicated in the development of neurocognitive dysfunction .
BACKGROUND	Niacin ( vitamin B3 ) is able to control the excess tryptophan oxidation , correcting tryptophan depletion , and therefore represents an interesting strategy to improve CD4 recovery.We aim to design a crossover proof-of-concept study to assess supplementation with an extended-release form of niacin ( Niaspan FCT ) in combination with antiretroviral therapy , compared to antiretroviral therapy alone , on T-cell immune activation as defined by changes in the percentage of CD8 + CD38 + HLA-DR + T-cells .
METHODS	This randomized , open-label , interventional crossover study with an immediate versus deferred use of Niaspan FCT for 24 weeks will assess its ability to reduce immune activation and thus increase CD4 recovery in 20 HIV-infected individuals with suboptimal immune responses despite sustained virologic suppression .
METHODS	A substudy evaluating neurocognitive function will also be conducted .
CONCLUSIONS	This randomized trial will provide an opportunity to evaluate the potential benefit of oral extended-release niacin , a drug that can indirectly increase tryptophan , to reduce immune activation and in turn increase CD4 + T-cell recovery .
CONCLUSIONS	The study will also allow for the evaluation of the impact of Niaspan FCT on neurocognitive function in HIV-infected individuals with suboptimal immune responses despite sustained virologic suppression .
BACKGROUND	This study was registered with ClinicalTrials.gov on 17 December 2013 ( registration number : NCT02018965 ) .

###25137215
OBJECTIVE	We examined how individual motivational orientations and anticipated regret are related to the protective health decision of vaccination behaviour .
METHODS	The proposed relations were examined in a large-scale sample ( N = 3168 ) and three medium-sized samples ( N = 151 , N = 194 , N = 208 ) .
METHODS	Questionnaires were applied to assess regulatory focus , anticipated regret and vaccination behaviour .
RESULTS	Increased prevention-focused self-regulation - which is represented by concerns about security-related goals , responsibilities and obligations - was related to a greater likelihood of vaccination .
RESULTS	Prevention-focused individuals ' higher likelihood of getting vaccinated seems at least in part to be a consequence of anticipated regret for not vaccinating .
RESULTS	Study 3 suggests that regulatory focus is less related to vaccination decisions when regret is increased by the decision-making context ; that is , when information highlighting vaccination effectiveness and a low likelihood of adverse responses is provided .
CONCLUSIONS	Prevention-focused self-regulation is related to a greater likelihood of engaging in health-protective behaviour .
CONCLUSIONS	This can be explained by prevention-focused individuals ' greater tendency to anticipate regret about getting ill as a consequence of not adopting protective measures .
CONCLUSIONS	If people perceive a protective measure such as a vaccination as highly effective , anticipated regret for not adopting it is generally increased , and individual differences in regulatory focus no longer predict the decision .

###24704626
OBJECTIVE	Individuals with mixed dyslipidemia have elevated triglycerides ( TG ) , low high-density lipoprotein cholesterol ( HDL-C ) , and increased risk for coronary disease .
OBJECTIVE	Fibrate therapy is commonly used to lower TG and increase HDL-C .
OBJECTIVE	Common genetic variants are known to affect the response to fibrate therapy .
OBJECTIVE	We sought to identify rare genetic variants ( frequency 1 % ) in genes involved in TG and HDL-C metabolism that affect the response to fenofibric acid ( FA ) therapy .
METHODS	Four genes with a major role in HDL-C and TG metabolism APOA1 , APOC2 , APOC-III and LPL were sequenced in 2385 participants with mixed dyslipidemia in a randomized , double-blind , active-controlled study comparing therapy with FA alone , in combination with statins , or statin alone .
METHODS	Rare variants collapsing or SKAT methods were used for the analysis .
RESULTS	Synonymous rare variants in the LPL gene were significantly associated with absolute HDL-C change ( P = 9 10 ( -4 ) ) and TG percent change ( P = 6.76 10 ( -4 ) ) in those treated with FA only .
RESULTS	Participants with these rare variants had a 2 mg/dL increase in HDL-C and 39 mg/dL decrease in TG as compared to 6.2 mg/dL increase in HDL-C and 100 mg/dL decrease in TG in those without these variants .
RESULTS	Rare variants in the APOC-III gene were associated with a modest 3 mg/dL less reduction in APOB ( P = 8.72 10 ( -4 ) ) in those receiving FA and statin .
CONCLUSIONS	In individuals with mixed dyslipidemia rare synonymous variants within LPL gene were associated with attenuated response to FA therapy while APOCIII rare variants were associated with a modest effect on APOB response to FA-statin therapy .
CONCLUSIONS	These results should be replicated in a similar clinical trial for further confirmation .

###24932147
OBJECTIVE	Alternative therapies for childhood obstructive sleep apnea syndrome ( OSAS ) are needed as OSAS may persist despite adenotonsillectomy , and continuous positive airway pressure ( CPAP ) adherence is low .
OBJECTIVE	Nasal expiratory positive airway pressure ( NEPAP ) devices have not been studied in children .
OBJECTIVE	We hypothesized that NEPAP would result in polysomnographic improvement .
OBJECTIVE	Further , we aimed to determine NEPAP adherence , effects on sleepiness , behavior , and quality of life .
METHODS	A randomized , double-blind , placebo-controlled , crossover pilot study was performed .
METHODS	CPAP candidates , 8-16 years old , underwent NEPAP and placebo polysomnograms .
METHODS	Subjects with 50 % reduction in the apnea hypopnea index ( AHI ) from placebo to NEPAP night or AHI < 5/h on NEPAP night wore NEPAP at home for 30 days .
METHODS	Adherence was assessed by daily phone calls/emails and collecting used devices .
RESULTS	Fourteen subjects ( age 13.4 1.9 years , BMI z-scores 2.2 1 [ mean SD ] ) were studied .
RESULTS	There was significant improvement in the obstructive apnea index with NEPAP vs. placebo : 0.6 ( 0-21 .1 ) / h vs. 4.2 ( 0-41 .9 ) / h ( median [ range ] , p = 0.010 ) and trends for improvement in other polysomnographic parameters .
RESULTS	However , responses were variable , with 3 subjects not improving and 2 worsening .
RESULTS	Older children and those with less hypercapnia had a better response .
RESULTS	Eight subjects were sent home with devices ; one was lost to follow-up , and adherence in the remainder was 83 % of nights ; these subjects had a significant improvement in sleepiness and quality of life .
CONCLUSIONS	NEPAP devices are a potential alternative therapy for OSAS in a small subset of children .
CONCLUSIONS	Due to variability in individual responses , efficacy of NEPAP should be evaluated with polysomnography .
BACKGROUND	www.clinicaltrials.gov , identifier : NCT01768065 .

###25285681
BACKGROUND	Botulinum toxin A injection into the nonparalyzed side is used to treat asymmetry resulting from facial palsy .
BACKGROUND	OnabotulinumtoxinA and abobotulinumtoxinA units are not equivalent .
BACKGROUND	The authors compared the conversion ratio of 1:3 in patients with facial palsy .
METHODS	Fifty-five patients ( age , 16 to 67 years ; 43 women ) with longstanding facial palsy were randomly treated with either onabotulinumtoxinA ( n = 25 ) or abobotulinumtoxinA ( n = 30 ) injections into the nonparalyzed side .
METHODS	Adverse effects , facial symmetry , subjective satisfaction , and Facial Disability Index were assessed after 1 and 6 months .
RESULTS	The incidence of adverse effects was higher with abobotulinumtoxinA ( 93.3 percent versus 64.0 percent ; p = 0.007 ) .
RESULTS	Clinical scores of the nonparalyzed side decreased after 1 month and increased again at 6 months , with no between-group differences .
RESULTS	Scores of the paralyzed side were lower in the onabotulinumtoxinA group before treatment , but similar in both groups thereafter .
RESULTS	The paralyzed side scores increased after 1 month , and at 6 months were still higher than the pretreatment scores in both groups .
RESULTS	Subjective assessment improved at all time points compared with pretreatment scores and differed between the two groups only at 1 month , when the abobotulinumtoxinA group was a bit too paralyzed .
RESULTS	The physical function and social/well-being function subscales of the Facial Disability Index did not differ between the two groups .
CONCLUSIONS	Both toxins efficiently reduced asymmetry in patients with facial palsy .
CONCLUSIONS	Adverse effects were higher with abobotulinumtoxinA at an equivalence ratio of 1:3 .
METHODS	Therapeutic , II .

###25239849
OBJECTIVE	Burn patients are at risk of hypovitaminosis D and osteopenia or sarcopenia .
OBJECTIVE	Vitamin D pleiotropic effects may influence bone and muscle health .
OBJECTIVE	The aim of this pilot study was to assess effects of a cholecalciferol ( VD3 ) supplementation and an optimized calcium ( Ca ) regimen on vitamin D ( VD ) status , bone and muscle health during sequelar stage of burn injury .
METHODS	Monocentric randomized controlled trial .
METHODS	Fifteen adults with thermal burns dating from 2 to 5 years were randomized into two groups .
METHODS	For 12 months , they either received a quarterly IM injection of 200,000 IU VD3 and daily oral Ca ( Group D ) or placebo ( Group P ) .
METHODS	VD status and bone remodeling markers were assessed every 3 months .
METHODS	Knee muscle strength and bone mineral density were , respectively , assessed using isokinetic dynamometry and dual X-ray absorptiometry at initiation ( M0 ) and completion ( M12 ) of the protocol .
RESULTS	Of all the patients , 66 % presented with VD deficiency and 53 % ( with 3 men < 40y ) were considered osteopenic at inclusion .
RESULTS	After one year , calcidiol levels significantly increased in Group D to reach 40 ( 37-61 ) ng/ml .
RESULTS	No significant change in bone health was observed in both groups while Group D significantly improved quadriceps strength when tested at high velocity .
CONCLUSIONS	This VD3 supplementation was safe and efficient to correct hypovitaminosis D in burn adults .
CONCLUSIONS	When combined with optimized Ca intakes , it demonstrated positive effects on muscle health but not on bone health .
CONCLUSIONS	A high prevalence of hypovitaminosis D and osteopenia in these patients , as well as their wide range of muscle performances , seem to be worrying when considering rehabilitation and quality of life .

###24564933
OBJECTIVE	To examine in patients with early rheumatoid arthritis ( RA ) whether quality of life ( QoL ) , independently of disease activity , is affected by tight control treatment strategy schemes .
METHODS	In the Computer Assisted Management in Early RA ( CAMERA ) trials , patients with early RA , disease duration < 1 year , no prior use of DMARDs ) had been randomised to a methotrexate ( MTX ) - based tight control strategy or usual care ( CAMERA study ) or to 10 mg/d prednisone or placebo both added from start to a MTX-based tight control strategy ( CAMERA-II study ) .
METHODS	In either study , randomisation to the more intensive strategy resulted in lower disease activity .
METHODS	To assess QoL , the ` Influence of Rheumatic Diseases on General Health and Lifestyle ' questionnaire ( IRGL ) was used .
METHODS	Baseline and 1 - and/or 2-year measurements were analysed with regression analyses with the IRGL ( sub ) scales as outcome variables and treatment strategy and disease activity assessing 28 joints ( DAS28 ) as independent variables , correcting for baseline values of each scale and possible confounders ( gender , age , rheumatoid factor status ) .
RESULTS	There was no clear association between either of the treatment strategies and QoL , but a decrease in DAS28 was associated with improvement in the majority of QoL ( sub ) scales .
CONCLUSIONS	No independent effect of the specific tight control strategies schemes on QoL was found , while there was a clear disease activity related effect .
CONCLUSIONS	Thus frequent outpatient visits or the inclusion of prednisone in a tight control strategy did not negatively influence QoL .

###24929796
BACKGROUND	One of the main causes of mortality and morbidity following subarachnoid hemorrhage ( SAH ) is the development of cerebral vasospasm , a frequent complication arising in the weeks after the initial bleeding .
BACKGROUND	Despite extensive research , no effective treatment of vasospasm exists to date .
BACKGROUND	Prostacyclin is a potent vasodilator and inhibitor of platelet aggregation .
BACKGROUND	In vitro models have shown a relaxing effect of prostacyclin after induced contraction in cerebral arteries , and a recent pilot trial showed a positive effect on cerebral vasospasm in a clinical setting .
BACKGROUND	No randomized clinical trials have investigated the possible pharmacodynamic effects of prostacyclin on the human brain following SAH .
METHODS	This trial is a single centre , randomized , placebo-controlled , parallel group , double blinded , clinical pilot trial .
METHODS	A total of 90 patients with SAH will be randomized to one of three intervention arms : epoprostenol at 1 ng/kg/min , epoprostenol at 2 ng/kg/min , or placebo in addition to the standard treatment .
METHODS	Trial medication will start on Day 5 after SAH and continue to Day 10 .
METHODS	The primary outcome measure is changes in cerebral blood flow measured by a computed tomography ( CT ) perfusion scan .
METHODS	The secondary outcomes are vasospasm measured by a CT angiography , regional blood flow , clinical symptoms of cerebral ischemia , and outcome at three months ( Glasgow Outcome Scale ) .
CONCLUSIONS	The primary outcome has been altered slightly since the publication of our study protocol .
CONCLUSIONS	Global cerebral blood flow is now primary outcome , whereas regional blood flow is a secondary outcome .
BACKGROUND	Clinicaltrials.gov NCT01447095 .
BACKGROUND	Registration date : 11 October 2011 .

###24792229
BACKGROUND	Participatory patient-centered , web-based methods could streamline and improve the convenience of clinical trial participation .
BACKGROUND	We used an entirely web-based approach to conduct a randomized , placebo-controlled , Phase 4 ( REMOTE ) trial under an Investigational New Drug ( IND ) application to evaluate tolterodine extended release ( ER ) 4 mg for overactive bladder .
METHODS	The trial was designed to replicate previous clinic-based trials of tolterodine ER but was conducted via the web from one clinical site overseen by physicians .
METHODS	Participants were recruited via the web , screened for eligibility using web-based questionnaires , had laboratory testing in their community , and entered a run-in phase requiring bladder e-diaries .
METHODS	Informed consent was obtained using an interactive web-based method with physician countersignature .
METHODS	Study medication was shipped directly to participants .
RESULTS	With a goal of 283 randomized participants , 5157 registered on the trial website .
RESULTS	Of 456 who passed initial screening , identification verification , and signed consent , 237 passed additional medical screening and were countersigned by the investigator .
RESULTS	After laboratory testing , 118 entered the placebo run-in ; only 18 passed e-diary assessments and were randomized to treatment .
RESULTS	At week 12 , the mean change from the baseline in micturitions/24 hours ( primary endpoint ) was -2.4 for tolterodine ER versus -0.8 for placebo [ treatment difference ( 95 % CI ) : -1.6 ( -3.9 , 0.6 ) ] .
CONCLUSIONS	The REMOTE trial is the first entirely web-based trial conducted under an IND application .
CONCLUSIONS	The efficacy observed was consistent with results from conventional trials .
CONCLUSIONS	With simplification of multi-step screening and testing , web-based trials or their component parts should provide a participant-friendly approach to many clinical trials .

###24517299
BACKGROUND	Increasing demand for palliative care unit ( PCU ) admissions has led to a stronger focus on discharge planning .
BACKGROUND	This has resulted in shorter inpatient length of stays ( LOS ) , and stable patients not requiring specialist palliative care services being referred for placement in residential aged care facilities ( RACFs ) .
BACKGROUND	The process of placement is time-consuming and can be distressing to patients and families , so RACF placement should only be proposed in patients whose prognosis is relatively good ( i.e. , weeks to months ) .
OBJECTIVE	Our aim was to identify the outcomes of palliative care inpatients referred for residential aged care placement .
METHODS	A retrospective chart audit was conducted .
METHODS	The patients ' outcomes ( discharge or death and survival time ) were recorded and analyzed using SPSS statistical software .
METHODS	Subjects were 100 consecutive inpatients from a 30-bed PCU who had been referred for RACF placement .
RESULTS	Of the 100 patients referred for RACF placement 73 of 100 ( 73 % ) patients had a malignant diagnosis , whereas 27 ( 27 % ) had a noncancer diagnosis .
RESULTS	Thirty-eight ( 38 % ) patients died before discharge , including 33 of 73 ( 45 % ) patients with cancer and 5 of 27 ( 13 % ) patients with nonmalignant conditions .
RESULTS	In particular , 12 of 17 ( 71 % ) patients with metastatic non-small cell lung ( NCSLC ) cancer died before or soon after discharge .
CONCLUSIONS	Over one-third of all patients died before discharge to an RACF could take place .
CONCLUSIONS	The rate of death before discharge was higher among patients who had cancer .
CONCLUSIONS	Patients suffering from NCSLC need to be more carefully selected for placement as only one-third of these patients survived to discharge .

###24704737
BACKGROUND	Human patient simulation has been widely adopted in healthcare education despite little research supporting its efficacy .
BACKGROUND	The debriefing process is central to simulation education , yet alternative evaluation methods to support providing optimal feedback to students have not been well explored .
BACKGROUND	Eye tracking technology is an innovative method for providing objective evaluative feedback to students after a simulation experience .
BACKGROUND	The purpose of this study was to compare 3 forms of simulation-based student feedback ( verbal debrief only , eye tracking only , and combined verbal debrief and eye tracking ) to determine the most effective method for improving student knowledge and performance .
METHODS	An experimental study using a pretest-posttest design was used to compare the effectiveness of 3 types of feedback .
METHODS	The subjects were senior baccalaureate nursing students in their final semester enrolled at a large university in the northeast United States .
METHODS	Students were randomly assigned to 1 of the 3 intervention groups .
RESULTS	All groups performed better in the posttest evaluation than in the pretest .
RESULTS	Certain safety practices improved significantly in the eye tracking-only group .
RESULTS	These criteria were those that required an auditory and visual comparison of 2 artifacts such as `` Compares patient stated name with name on ID band . ''
CONCLUSIONS	Eye tracking offers a unique opportunity to provide students with objective data about their behaviors during simulation experiences , particularly related to safety practices that involve the comparison of patient stated data to an artifact such as an ID band .
CONCLUSIONS	Despite the limitations of current eye tracking technology , there is significant potential for the use of this technology as a method for the study and evaluation of patient safety practices .

###24439973
BACKGROUND	The Absorb everolimus-eluting bioresorbable vascular scaffold ( AbsorbBVS ) is a completely resorbable device engineered to overcome the limitations of permanent metallic stents , providing temporary scaffolding and antiproliferative drug delivery for the treatment of obstructive coronary artery disease .
METHODS	The objective of the AIDA trial is to evaluate the efficacy and performance in an contemporary all-comer population of the AbsorbBVS strategy vs the XIENCE family everolimus-eluting metallic coronary stent system in the treatment of coronary lesions .
METHODS	The AIDA trial is a prospective , randomized ( 1:1 ) , active-control , single-blinded , all-comer , noninferiority trial .
METHODS	A total of 2,690 subjects will be enrolled with broad inclusion and limited exclusion criteria according to the `` Instructions for Use '' of the AbsorbBVS strategy .
METHODS	The study population includes both simple and complex lesions , in patients with stable and acute coronary syndrome .
METHODS	The follow-up continues for 5years .
METHODS	The primary end point of the trial is target vessel failure , defined as the composite of cardiac death , myocardial infarction , and target vessel revascularization , at 2years .
METHODS	This study is registered on ClinicalTrials.gov with number NCT01858077 .
CONCLUSIONS	The AIDA trial will provide the first randomized direct comparison between the everolimus-eluting bioresorbable vascular scaffold and the everolimus-eluting metallic stent in contemporary percutaneous coronary intervention practice .

###25022762
BACKGROUND	Lateral epicondylitis , commonly known as tennis elbow , is the most common cause of lateral elbow pain and the second most frequently diagnosed musculoskeletal disorder in the neck and upper limb in a primary care setting .
BACKGROUND	Many therapeutic options , including conservative , surgical , and minimally invasive procedures , have been advocated for the treatment of lateral epicondylitis .
BACKGROUND	Although numerous small studies have been performed to assess the efficacy of various treatments , there are conflicting results with no clear consensus on the optimal treatment .
BACKGROUND	In an economic environment with limited health care resources , it is paramount that optimal cost-effective therapies with favorable patient-important outcomes be identified .
METHODS	This is a protocol paper which outlines a multicenter , multidisciplinary , single-blinded , four-arm randomized controlled trial , comparing platelet-rich plasma ( PRP ) , whole blood injection , dry needle tendon fenestration , and sham injection with physical therapy alone for the treatment of lateral epicondylitis .
METHODS	Patients are screened based on pre-established eligibility criteria and randomized to one of the four study groups using an Internet-based system .
METHODS	The patients are followed at 6-week , 12-week , 24-week , and 52-week time points to assess the primary and secondary outcomes of the study .
METHODS	The primary outcome is pain .
METHODS	Secondary outcomes include health-related quality of life and ultrasound appearance of the common extensor tendon .
METHODS	Two university centers ( McMaster University and the University of Michigan ) are currently recruiting patients .
METHODS	We have planned a sample size of 100 patients ( 25 patients per arm ) to ensure over 80 % power to detect a three-point difference in pain scores at 52weeks of follow-up .
BACKGROUND	This study has ethics approval from the McMaster University Research Ethics Board ( REB # 12-146 ) and the University of Michigan Institutional Review Board ( IRB # HUM00067750 ) .
BACKGROUND	Successful completion of this proposed study will significantly impact clinical practice and enhance patients ' lives .
BACKGROUND	More broadly , this trial will develop a network of collaboration from which further high-quality trials in ultrasound-guided interventions will follow .

###25164700
BACKGROUND	Fatigue is a common symptom of chronic hepatitis C virus ( HCV ) infection and a frequent side-effect of peginterferon/ribavirin ( PR ) therapy for HCV .
BACKGROUND	This study evaluated the impact of adding the oral HCV NS3/4A protease inhibitor simeprevir to PR on patient-reported fatigue and health status among patients with chronic HCV genotype 1 infection enrolled in the Phase IIb PILLAR and ASPIRE trials [ NCT00882908 ; NCT00980330 ] .
METHODS	Treatment-nave patients ( PILLAR , n = 386 ) and treatment-experienced patients ( ASPIRE , n = 462 ) were randomized to simeprevir plus PR ( simeprevir/PR ) or placebo plus PR ( placebo/PR ) .
METHODS	In PILLAR , duration of PR treatment in the simeprevir/PR groups was determined using response-guided therapy ( RGT ) criteria .
METHODS	PR could be terminated at Week 24 , instead of Week 48 , if HCV RNA was < 25IU/mL by Week 4 and then undetectable at Weeks 12 , 16 , and 20 .
METHODS	In both studies , patients completed the Fatigue Severity Scale ( FSS ) and EQ-5D quality-of-life questionnaire in their native language at baseline and throughout the studies up until Week 72 .
RESULTS	During the first 24weeks of treatment , mean FSS total score was increased to a similar degree compared with baseline among patients receiving simeprevir/PR or placebo/PR in both studies indicating increased fatigue severity .
RESULTS	Mean FSS scores returned to values comparable with baseline among patients receiving simeprevir/PR after Week 24 in PILLAR ( after treatment completion for the majority of patients ) and in ASPIRE ( after Week 48 ) , consistent with RGT enabling early termination of all treatment at Week 24 in 82.2 % of simeprevir/PR-treated patients in the PILLAR study .
RESULTS	Similar results were observed for EQ-5D , with simeprevir/PR-treated patients experiencing less time with worse health problems according to EQ-5D scores compared with placebo/PR groups in both studies , and more rapid improvement in health status associated with shorter treatment duration in the PILLAR study .
CONCLUSIONS	Combination of simeprevir with PR did not increase patient-reported fatigue severity or health status impairments beyond that reported by patients treated with PR alone .
CONCLUSIONS	Many patients treated with simeprevir/PR returned to pretreatment fatigue and health status levels sooner due to increased treatment efficacy that enabled shorter duration of all therapy , compared with PR alone .

###25327352
BACKGROUND	The development of specific antibodies against human leukocyte antigen ( HLA ) and/or human platelet antigen ( HPA ) could induce platelet transfusion refractoriness especially in patients receiving multiple platelet transfusions .
BACKGROUND	A retrospective analysis was conducted to evaluate the prevalence of platelet-specific antibodies and the efficacy of crossmatch-compatible platelet transfusions in these recipients .
METHODS	All enrolled patients were refractory to random single-donor apheresis Platelet ( PLT ) units .
METHODS	Enzyme-linked immunosorbent assay ( ELISA ) was used to detect anti-HLA and anti-HPA antibodies in serum .
METHODS	For those patients with antibodies , the PLT crossmatch assays were performed to select the compatible PLTs with a commercial solid-phase adherence kit .
RESULTS	A total of 193 patients were included and 29.02 % of which was HLA and/or HPA antibody-positive .
RESULTS	There were no significant differences in antibody-positive rates among AML/CML , ALL/CLL , MDS , SAA and ITP groups , but they are statistically significantly higher than other groups ( P = 0.0035 ) .
RESULTS	Of those antibody-positive patients , there were 41 ( 73.21 % ) patients with only HLA antibodies , 11 ( 19.64 % ) patients with only HPA antibodies and 4 ( 7.14 % ) patients with both HLA and HPA antibodies .
RESULTS	A total of 43 random PLT units and 88 crossmatch-compatible PLT units were administered .
RESULTS	The mean ( SD ) corrected count increment ( CCI ) was 8700 ( 4500 ) after crossmatch-compatible unit transfusion , significantly higher than 3600 ( 2400 ) for random PLT units ( P < 0.001 ) .
CONCLUSIONS	HLA and/or HPA alloimmunisation is an important factor to cause refractoriness to platelet transfusions .
CONCLUSIONS	Crossmatch-compatible platelet transfusion is an effective method in those patients refractory to random platelet transfusions .

###25549192
BACKGROUND	Volume expansion and hypertension are widely used for the hemodynamic management of patients with subarachnoid hemorrhage .
OBJECTIVE	To investigate the feasibility , adherence , and retention in a trial of volume expansion and blood pressure manipulation to prevent delayed cerebral ischemia .
METHODS	A randomized pilot trial using a 2-way factorial design allocating patients within 72 hours of subarachnoid hemorrhage to either normovolemia ( NV ) or volume expansion ( HV ) and simultaneously to conventional ( CBP ) or augmented blood pressure ( ABP ) for 10 days .
METHODS	The study endpoints were protocol adherence and retention to follow-up .
METHODS	The quality of endpoints for a larger trial were 6-month modified Rankin Scale score , comprehensive neurobehavioral assessment , delayed cerebral ischemia , new stroke , and discharge disposition .
RESULTS	Twenty patients were randomized and completed follow-up .
RESULTS	The overall difference in daily mean intravenous fluid intake was 2099 mL ( 95 % confidence interval [ CI ] : 867 , 3333 ) , HV vs NV group .
RESULTS	The overall mean systolic blood pressure difference was 5 mm Hg ( 95 % CI : -4.65 , 14.75 ) , ABP vs CBP group .
RESULTS	Adverse events included death ( n = 1 ) , delayed cerebral ischemia ( n = 1 ) , and pulmonary complications ( n = 3 ) .
RESULTS	There were no differences in modified Rankin Scale score between HV and NV ( difference 0.1 ; 95 % CI : -1.26 , 1.46 , P = .87 ) or between ABP and CBP groups ( -0.5 , 95 % CI : -1.78 , 0.78 , P = .43 ) .
RESULTS	Neuropsychological scores were similar between HV vs NV , but tended to be worse in ABP ( 5727 ) vs CBP group ( 8521 , P = .04 ) .
CONCLUSIONS	This pilot study showed adequate feasibility and excellent retention to follow-up .
CONCLUSIONS	Given the suggestion of possible worse neurobehavioral outcome with ABP , a larger trial to determine the optimal blood pressure management in this patient population is warranted .
CONCLUSIONS	( ClinTrials.gov NCT01414894 . )

###26063066
BACKGROUND	Complementing infant diets with lipid-based nutrient supplements ( LNSs ) has been suggested to improve growth and reduce morbidity , but the daily quantity and the milk content of LNSs affect their cost .
OBJECTIVE	We tested the hypotheses that the change in mean length-for-age z score ( LAZ ) for infants provided with 10-40 g LNSs/d from ages 6 to 18 mo would be greater than that for infants receiving no dietary intervention at the same age and that provision of LNSs that did not contain milk would be as good as milk-containing LNSs in promoting linear growth .
METHODS	We enrolled in a randomized single-blind trial 6-mo-old infants who were allocated to 1 of 6 groups to receive 10 , 20 , or 40 g LNSs/d containing milk powder ; 20 or 40 g milk-free LNSs/d ; or no supplement until 18 mo of age .
METHODS	The primary outcome was change in LAZ .
RESULTS	Of the 1932 enrolled infants , 78 ( 4.0 % ) died and 319 ( 16.5 % ) dropped out during the trial .
RESULTS	The overall reported supplement consumption was 71.6 % of days , with no difference between the groups ( P = 0.26 ) .
RESULTS	The overall mean SD length and LAZ changes were 13.0 2.1 cm and -0.45 0.77 z score units , respectively , which did not differ between the groups ( P = 0.66 for length and P = 0.74 for LAZ ) .
RESULTS	The difference in mean LAZ change in the no-milk LNS group compared with the milk LNS group was -0.02 ( 95 % CI : -0.10 , 0.06 ; P = 0.72 ) .
CONCLUSIONS	Our results do not support the hypothesis that LNS supplementation during infancy and childhood promotes length gain or prevents stunting between 6 and 18 mo of age in Malawi .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT00945698 .

###25462662
BACKGROUND	Few studies have examined the relation between impulsivity and drug involvement with prison inmates , in spite of their heavy drug use .
BACKGROUND	Among this small body of work , most studies look at clinically relevant drug dependence , rather than drug use specifically .
METHODS	N = 242 adult inmates ( 34.8 % female , 52 % White ) with an average age of 35.58 ( SD = 9.19 ) completed a modified version of the 15-item Barratt Impulsiveness Scale ( BIS ) and measures assessing lifetime alcohol , opiate , benzodiazepine , cocaine , cannabis , hallucinogen , and polysubstance use .
METHODS	Lifetime users also reported the frequency of use for the 30days prior to incarceration .
RESULTS	Impulsivity was higher among lifetime users ( versus never users ) of all substances other than cannabis .
RESULTS	Thirty day drug use frequency was only related to impulsivity for opiates and alcohol .
CONCLUSIONS	This study extends prior work , by showing that a lifetime history of non-clinical substance use is positively associated with impulsivity among prison inmates .
CONCLUSIONS	Implications for drug interventions are considered for this population , which is characterized by high rates of substance use and elevated impulsivity .

###24410834
BACKGROUND	Diabetes mellitus ( DM ) accelerates plaque progression despite the use of statin therapy .
BACKGROUND	The purpose of the present study was to evaluate the determinants of atheroma progression in statin-treated patients with DM .
METHODS	Coronary atherosclerosis in nonculprit lesions in a vessel undergoing percutaneous coronary intervention ( PCI ) was evaluated using virtual histology intravascular ultrasound .
METHODS	The study included 50 patients with DM who had been taking statin therapy for 8 months at the time of PCI .
RESULTS	Twenty-six patients ( 52 % ) showed atheroma progression ( progressors ) and the remaining 24 patients ( 48 % ) showed atheroma regression ( regressors ) after 8 months of follow-up .
RESULTS	Fewer progressors than regressors received intensive lipid-lowering therapy with pitavastatin ( 31 % vs. 50 % , p = 0.17 ) and the frequency of insulin use was higher in progressors ( 31 % vs. 13 % , p = 0.18 ) .
RESULTS	However , neither of these differences reached statistical significance .
RESULTS	Risk factor control at baseline and at the 8-month follow-up did not differ between the 2 groups except for serum levels of eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) .
RESULTS	Univariate regression analysis showed that serum EPA ( r = -0.317 , p = 0.03 ) and DHA ( r = -0.353 , p = 0.02 ) negatively correlated with atheroma progression .
RESULTS	Multivariate stepwise regression analysis showed that low serum DHA and pravastatin use were significant independent predictors for atheroma progression during statin therapy ( DHA : = -0.414 , type of statin : = -0.287 , p = 0.001 ) .
CONCLUSIONS	Low serum DHA is associated with progression of coronary atherosclerosis in statin-treated patients with DM .
BACKGROUND	UMIN Clinical Trials Registry , UMIN ID : C000000311 .

###24675145
OBJECTIVE	Superficial venous reflux and varicose veins are common .
OBJECTIVE	The aim of this randomized controlled trial was to assess effectiveness of compression therapy compared with surgery for superficial venous reflux .
METHODS	153 patients with CEAP class C2-C3 and superficial venous reflux were randomized to receive either conservative treatment ( compression stockings ) ( n = 77 ) or surgery ( n = 76 ) .
METHODS	Clinical examination including duplex ultrasound ( DUS ) was performed at entry and 1 and 2 years after randomization ( compression group ) or surgery ( surgery group ) .
METHODS	Venous Clinical Severity Score without compression stockings ( VCSS-S ) , Venous Segmental Disease Score ( VSDS ) , Venous Disability Score ( VDS ) , and health-related quality of life ( HRQoL ) were assessed at entry and at the follow-ups .
METHODS	Data were analysed on an intention-to-treat basis and according to the actual treatment performed .
RESULTS	At 2 years , 70/76 patients in the surgery group and 11/77 patients in the compression group had been operated on .
RESULTS	VCSS-S decreased from 4.6 to 3.5 in the compression group ( p < .01 ) and from 4.8 to 0.6 in the surgery group ( p < .001 ) .
RESULTS	VSDS decreased from 7.7 to 7.0 in the compression group and from 8.2 to 0.9 in the surgery group ( p < .0001 ) .
RESULTS	HRQoL did not change in the compression group , but improved significantly in the surgery group .
CONCLUSIONS	The surgical elimination of non-complicated superficial venous reflux is an effective treatment when compared with providing compression stockings only .

###25264726
BACKGROUND	Minimally invasive procedures , e.g. video-assisted thoracoscopic lobectomy , are less traumatic and thus one may expect a lower level of postoperative pain compared to open procedures .
BACKGROUND	This assumption is supported by several studies/metaanalyses .
BACKGROUND	However , confirmation by larger prospective randomised studies is lacking .
BACKGROUND	In the present study we analysed 2 groups of patients with lobectomy for early-stage lung cancer performed by VATS or by antero-lateral thoracotomy .
METHODS	66 patients with early-stage NSC lung cancer were randomised to VATS lobectomy ( A ) or open resection ( B ) .
METHODS	Two patients from A were excluded .
METHODS	The 2 groups were equally large ( n = 32 ) .
METHODS	All patients received the same analgetic therapy regime during and after surgery .
METHODS	We defined the early postoperative period as the first 10 days after operation and evaluated the intensity of pain ( assessed by NAS ) and the medication .
METHODS	Data acquisition was performed until discharge or the 10th postoperative day .
RESULTS	21 values for mean NAS were calculated for both groups and each situation ( at rest or under movement ) .
RESULTS	For 8 a significant difference resulted in favour of VATS .
RESULTS	In open thoracotomy the postoperative pain level was acceptable ( NAS < 4 ) due to our well established pain control management .
RESULTS	Also , 3 categories of patients with a very low pain profile were defined : patients with NAS not over 4 at any point , patients without any pain ( NAS = 0 ) after a certain point or patients discharged without any pain .
RESULTS	The VATS procedure showed a higher proportion of patients in all 3 categories : 17 in A vs. 7 in B had a max .
RESULTS	NAS of 4 during the course ; 20 vs. 11 were free of pain at certain times and 22 vs. 12 were discharged without pain .
RESULTS	For both groups a painless postoperative course was achieved on day 6 ( range , 4-10 days for A/3 -10 for B ) .
RESULTS	The medication was adjusted according to intensity .
RESULTS	A difference was seen in favour of VATS for Sufentanil + Ropivacain via PDK and for Piritramid i.v.
CONCLUSIONS	Regardless of procedure ( VATS vs. open ) pain control can be achieved with an adequate analgetic regime .
CONCLUSIONS	For VATS during the first days a lower amount of medication is required .
CONCLUSIONS	The VATS group showed a higher proportion of patients with very low postoperative pain profile : patients with pain score always under 4 and patients without pain at certain points before the 10th postoperative day or at discharge .

###24432999
BACKGROUND	Dipeptidyl peptidase 4 ( DPP-4 ) inhibitors have been widely used in type 2 diabetes .
BACKGROUND	An important unanswered question concerns the effect of DPP-4 inhibition on - cell function in patients with autoimmune diabetes .
OBJECTIVE	The objective of the study was to investigate the effects of the DPP-4 inhibitor on - cell function in patients with recent-onset latent autoimmune diabetes in adults ( LADA ) .
METHODS	This study was an open-label , randomized-controlled study conducted in the Department of Endocrinology at the Second Xiangya Hospital .
METHODS	Thirty recently diagnosed LADA patients were randomized 1:1 to receive insulin therapy with 100 mg/d sitagliptin ( group A , n = 15 ) or without sitagliptin ( group B , n = 15 ) for 12 months .
METHODS	Fasting and 2-hour postprandial blood samples were obtained at baseline and after 3 , 6 , 9 , and 12 months of treatment to determine blood glucose , glycosylated hemoglobin , and C-peptide levels .
RESULTS	There were no differences in the clinical baseline data between the two groups .
RESULTS	During the 12 months of follow-up , there were no significant differences in glucose and glycosylated hemoglobin levels between the two groups .
RESULTS	At 12 months , fasting C-peptide ( FCP ) , 2-hour postprandial C-peptide ( CP ) , and CP ( CP = 2 h CP-FCP ) levels were not different in group A ( P > .05 ) compared with baseline , whereas in group B the levels of FCP , 2-hour CP and CP were significantly decreased compared with baseline ( P < .05 ) .
RESULTS	Levels of 2-hour CP were higher in group A than group B at 12 months ( P < .05 ) .
CONCLUSIONS	LADA patients treated with sitagliptin and insulin maintained - cell function by comparison with insulin alone .

###25375400
OBJECTIVE	Diabetic foot ulcers ( DFUs ) often pose a treatment problem .
OBJECTIVE	Bioengineered skin substitutes have been reported to result in accelerated diabetic wound healing .
OBJECTIVE	The purpose of this clinical trial was to evaluate the efficacy and safety of the autologous fibroblast-hyaluronic acid complex for treating DFUs .
METHODS	A stratified , randomised , controlled , multicentre study was carried out .
METHODS	Patients with DFUs were allocated to either a treatment group with grafting of an autologous fibroblast-hyaluronic acid complex or a control group with non-adherent foam dressing .
METHODS	Except for application of the fibroblast complex , treatment of the study ulcers was identical for patients in both groups .
METHODS	The maximum follow-up period for each patient was 12 weeks .
RESULTS	Complete ulcer healing was achieved in 84 % ( 26/31 patients ) of the treatment group and 34 % ( 11/32 patients ) of the control group ( p < 0.05 ) .
RESULTS	The times required for complete healing were 36.4 17.6 and 48.4 13.1 days in the treatment and control groups , respectively ( p < 0.05 ) .
RESULTS	No adverse events related to treatment occurred .
CONCLUSIONS	These results indicate that autologous fibroblast-hyaluronic acid complex may offer a safe and effective treatment for DFUs .

###25425214
BACKGROUND	Gastrointestinal graft-versus-host disease ( GvHD ) is a potentially life-threatening complication after allogeneic stem cell transplantation ( SCT ) .
BACKGROUND	Since therapeutic options are still limited , a prophylactic approach seems to be warranted .
METHODS	In this randomised , double-blind-phase III trial , we evaluated the efficacy of budesonide in the prophylaxis of acute intestinal GvHD after SCT .
METHODS	The trial was registered at https://clinicaltrials.gov , number NCT00180089 .
RESULTS	The crude incidence of histological or clinical stage 3-4 acute intestinal GvHD until day 100 observed in 91 ( n = 48 budesonide , n = 43 placebo ) evaluable patients was 12.5 % ( 95 % CI 3-22 % ) under treatment with budesonide and 14 % ( 95 % CI 4-25 % ) under placebo ( p = 0.888 ) .
RESULTS	Histologic and clinical stage 3-4 intestinal GvHD after 12 months occurred in 17 % ( 95 % CI 6-28 % ) of patients in the budesonide group and 19 % ( CI 7-32 % ) in the placebo group ( p = 0.853 ) .
RESULTS	Although budesonide was tolerated well , we observed a trend towards a higher rate of infectious complications in the study group ( 47.9 % versus 30.2 % , p = 0.085 ) .
RESULTS	The cumulative incidences at 12 months of intestinal GvHD stage > 2 with death as a competing event ( budesonide 20.8 % vs. placebo 32.6 % , p = 0.250 ) and the cumulative incidence of relapse ( budesonide 20.8 % vs. placebo 16.3 % , p = 0.547 ) and non-relapse mortality ( budesonide 28 % ( 95 % CI 15-41 % ) vs. placebo 30 % ( 95 % CI 15-44 % ) , showed no significant difference within the two groups ( p = 0.911 ) .
RESULTS	The trial closed after 94 patients were enrolled because of slow accrual .
RESULTS	Within the limits of the final sample size , we were unable to show any benefit for the addition of budesonide to standard GvHD prophylaxis .
CONCLUSIONS	Budesonide did not decrease the occurrence of intestinal GvHD in this trial .
CONCLUSIONS	These results imply most likely that prophylactic administration of budenoside with pH-modified release in the terminal ileum is not effective .

###26002889
BACKGROUND	Oxygen is commonly administered to patients with ST-elevation-myocardial infarction despite previous studies suggesting a possible increase in myocardial injury as a result of coronary vasoconstriction and heightened oxidative stress .
RESULTS	We conducted a multicenter , prospective , randomized , controlled trial comparing oxygen ( 8 L/min ) with no supplemental oxygen in patients with ST-elevation-myocardial infarction diagnosed on paramedic 12-lead ECG .
RESULTS	Of 638 patients randomized , 441 patients had confirmed ST-elevation-myocardial infarction and underwent primary end-point analysis .
RESULTS	The primary end point was myocardial infarct size as assessed by cardiac enzymes , troponin I , and creatine kinase .
RESULTS	Secondary end points included recurrent myocardial infarction , cardiac arrhythmia , and myocardial infarct size assessed by cardiac magnetic resonance imaging at 6 months .
RESULTS	Mean peak troponin was similar in the oxygen and no oxygen groups ( 57.4 versus 48.0 g/L ; ratio , 1.20 ; 95 % confidence interval , 0.92-1 .56 ; P = 0.18 ) .
RESULTS	There was a significant increase in mean peak creatine kinase in the oxygen group compared with the no oxygen group ( 1948 versus 1543 U/L ; means ratio , 1.27 ; 95 % confidence interval , 1.04-1 .52 ; P = 0.01 ) .
RESULTS	There was an increase in the rate of recurrent myocardial infarction in the oxygen group compared with the no oxygen group ( 5.5 % versus 0.9 % ; P = 0.006 ) and an increase in frequency of cardiac arrhythmia ( 40.4 % versus 31.4 % ; P = 0.05 ) .
RESULTS	At 6 months , the oxygen group had an increase in myocardial infarct size on cardiac magnetic resonance ( n = 139 ; 20.3 versus 13.1 g ; P = 0.04 ) .
CONCLUSIONS	Supplemental oxygen therapy in patients with ST-elevation-myocardial infarction but without hypoxia may increase early myocardial injury and was associated with larger myocardial infarct size assessed at 6 months .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01272713 .

###24292995
OBJECTIVE	To develop prognostic models for time to 12-month remission and time to treatment failure after initiating antiepileptic drug monotherapy for generalised and unclassified epilepsy .
METHODS	We analysed data from the Standard and New Antiepileptic Drug ( arm B ) study , a randomised trial that compared initiating treatment with lamotrigine , topiramate and valproate in patients diagnosed with generalised or unclassified epilepsy .
METHODS	Multivariable regression modelling was used to investigate how clinical factors affect the probability of achieving 12-month remission and treatment failure .
RESULTS	Significant factors in the multivariable model for time to 12-month remission were having a relative with epilepsy , neurological insult , total number of tonic-clonic seizures before randomisation , seizure type and treatment .
RESULTS	Significant factors in the multivariable model for time to treatment failure were treatment history ( antiepileptic drug treatment prior to randomisation ) , EEG result , seizure type and treatment .
CONCLUSIONS	The models described within this paper can be used to identify patients most likely to achieve 12-month remission and most likely to have treatment failure , aiding individual patient risk stratification and the design and analysis of future epilepsy trials .

###25779558
OBJECTIVE	The efficacy of lapatinib versus trastuzumab combined with taxanes in the first-line setting of human epidermal growth factor receptor 2 ( HER2 ) - positive metastatic breast cancer ( BC ) is unknown .
METHODS	The MA .31 trial compared a combination of first-line anti-HER2 therapy ( lapatinib or trastuzumab ) and taxane therapy for 24 weeks , followed by the same anti-HER2 monotherapy until progression .
METHODS	Stratification was by prior ( neo ) adjuvant anti-HER2 therapy , prior ( neo ) adjuvant taxane , planned taxane , and liver metastases .
METHODS	The primary end point was intention-to-treat ( ITT ) progression-free survival ( PFS ) , defined as time from random assignment to progression by RECIST ( version 1.0 ) criteria , or death for patients with locally assessed HER2-positive tumors .
METHODS	The primary test statistic was a stratified log-rank test for noninferiority .
METHODS	PFS was also assessed for patients with centrally confirmed HER2-positive tumors .
RESULTS	From July 17 , 2008 , to December 1 , 2011 , 652 patients were accrued from 21 countries , resulting in 537 patients with centrally confirmed HER2-positive tumors .
RESULTS	Median follow-up was 21.5 months .
RESULTS	Median ITT PFS was 9.0 months with lapatinib and 11.3 months with trastuzumab .
RESULTS	By ITT analysis , PFS was inferior for lapatinib compared with trastuzumab , with a stratified hazard ratio ( HR ) of 1.37 ( 95 % CI , 1.13 to 1.65 ; P = .001 ) .
RESULTS	In patients with centrally confirmed HER2-positive tumors , median PFS was 9.1 months with lapatinib and 13.6 months with trastuzumab ( HR , 1.48 ; 95 % CI , 1.20 to 1.83 ; P < .001 ) .
RESULTS	More grade 3 or 4 diarrhea and rash were observed with lapatinib ( P < .001 ) .
RESULTS	PFS results were supported by the secondary end point of overall survival , with an ITT HR of 1.28 ( 95 % CI , 0.95 to 1.72 ; P = .11 ) ; in patients with centrally confirmed HER2-positive tumors , the HR was 1.47 ( 95 % CI , 1.03 to 2.09 ; P = .03 ) .
CONCLUSIONS	As first-line therapy for HER2-positive metastatic BC , lapatinib combined with taxane was associated with shorter PFS and more toxicity compared with trastuzumab combined with taxane .

###24714008
BACKGROUND	Many studies comparing different intravenous fluid types usually do not use equipotent volumes of three to one crystalloid to colloid ratio in such comparisons .
BACKGROUND	Conflicting results emanate from such studies .
OBJECTIVE	This study was designed to compare the efficacy of equipotent volumes of colloid and crystalloid-colloid combination in spinal anesthesia-induced hypotension prophylaxis during cesarean section .
METHODS	A prospective randomized double blinded experimental study carried out in a tertiary hospital in Nigeria .
METHODS	Pregnant women scheduled for elective cesarean section were prospectively randomized into two groups to receive either 1000 ml of crystalloid/colloid ( 750/250 ml ) combination or 500 ml colloid intravenous fluid preload , before spinal anesthesia .
METHODS	Hemodynamic variables were monitored till the end of surgery .
METHODS	The results were collated , analyzed , and rational conclusions deduced .
METHODS	Data collected and analyzed with Statistical Package for Social Sciences ( SPSS ) version 16 and rational deductions derived .
RESULTS	In the first 10 min , the crystalloid-colloid combination showed better efficacy in hypotension prophylaxis over the colloid only regimen .
RESULTS	In the next 30 min ; however , there was no significant difference between both groups in hemodynamic parameters .
CONCLUSIONS	Beyond 10 min the crystalloid-colloid combination has no advantage over colloid alone in hypotension prophylaxis , as used in this study .

###25099550
BACKGROUND	The dorsolateral prefrontal cortex ( DLPFC ) plays an important role in appetite and food intake regulation .
OBJECTIVE	Because previous data revealed that transcranial direct current stimulation ( tDCS ) of the DLPFC reduces food cravings , we hypothesized that repetitive electric stimulation of the right DLPFC would lower food intake behavior in humans .
METHODS	In a single-blind , code-based , placebo-controlled , counterbalanced , randomized crossover experiment , 14 healthy young men with body mass index ( in kg/m ( 2 ) ) from 20 to 25 were examined during 8 d of daily tDCS or a sham stimulation .
METHODS	After tDCS or sham stimulation on the first and the last day of both experimental conditions , participants consumed food ad libitum from a standardized test buffet .
RESULTS	One week of daily anodal tDCS reduced overall caloric intake by 14 % in comparison with sham stimulation .
RESULTS	Moreover , repetitive tDCS diminished self-reported appetite scores .
CONCLUSIONS	Our study implies that the application of anodal direct currents to the right DLPFC represents a promising option for reducing both caloric intake and appetite in humans .
CONCLUSIONS	This trial was registered at the German Clinical Trials Register ( www.germanctr.de ) as DRKS00005811 .

###24835753
OBJECTIVE	To compare the effect of a custom-designed yoga program with 2 other balance training programs .
METHODS	Randomized controlled trial .
METHODS	Research laboratory .
METHODS	A group of older adults ( N = 39 ; mean age , 74.15 6.99 y ) with a history of falling .
METHODS	Three different exercise interventions ( Tai Chi , standard balance training , yoga ) were given for 12 weeks .
METHODS	Balance performance was examined during pre - and posttest using field tests , including the 8-foot up-and-go test , 1-leg stance , functional reach , and usual and maximal walking speed .
METHODS	The static and dynamic balances were also assessed by postural sway and dynamic posturography , respectively .
RESULTS	Training produced significant improvements in all field tests ( P < .005 ) , but group difference and time group interaction were not detected .
RESULTS	For postural sway , significant decreases in the area of the center of pressure with eyes open ( P = .001 ) and eyes closed ( P = .002 ) were detected after training .
RESULTS	For eyes open , maximum medial-lateral velocity significantly decreased for the sample ( P = .013 ) .
RESULTS	For eyes closed , medial-lateral displacement decreased for Tai Chi ( P < .01 ) .
RESULTS	For dynamic posturography , significant improvements in overall score ( P = .001 ) , time on the test ( P = .006 ) , and 2 linear measures in lateral ( P = .001 ) and anterior-posterior ( P < .001 ) directions were seen for the sample .
CONCLUSIONS	Yoga was as effective as Tai Chi and standard balance training for improving postural stability and may offer an alternative to more traditional programs .

###25176395
BACKGROUND	Routine intracoronary thrombus aspiration before primary percutaneous coronary intervention ( PCI ) in patients with ST-segment elevation myocardial infarction ( STEMI ) has not been proved to reduce short-term mortality .
BACKGROUND	We evaluated clinical outcomes at 1 year after thrombus aspiration .
METHODS	We randomly assigned 7244 patients with STEMI to undergo manual thrombus aspiration followed by PCI or to undergo PCI alone , in a registry-based , randomized clinical trial .
METHODS	The primary end point of all-cause mortality at 30 days has been reported previously .
METHODS	Death from any cause at 1 year was a prespecified secondary end point of the trial .
RESULTS	No patients were lost to follow-up .
RESULTS	Death from any cause occurred in 5.3 % of the patients ( 191 of 3621 patients ) in the thrombus-aspiration group , as compared with 5.6 % ( 202 of 3623 ) in the PCI-only group ( hazard ratio , 0.94 ; 95 % confidence interval [ CI ] , 0.78 to 1.15 ; P = 0.57 ) .
RESULTS	Rehospitalization for myocardial infarction at 1 year occurred in 2.7 % and 2.7 % of the patients , respectively ( hazard ratio , 0.97 ; 95 % CI , 0.73 to 1.28 ; P = 0.81 ) , and stent thrombosis in 0.7 % and 0.9 % , respectively ( hazard ratio , 0.84 ; 95 % CI , 0.50 to 1.40 ; P = 0.51 ) .
RESULTS	The composite of death from any cause , rehospitalization for myocardial infarction , or stent thrombosis occurred in 8.0 % and 8.5 % of the patients , respectively ( hazard ratio , 0.94 ; 95 % CI , 0.80 to 1.11 ; P = 0.48 ) .
RESULTS	The results were consistent across all the major subgroups , including grade of thrombus burden and coronary flow before PCI .
CONCLUSIONS	Routine thrombus aspiration before PCI in patients with STEMI did not reduce the rate of death from any cause or the composite of death from any cause , rehospitalization for myocardial infarction , or stent thrombosis at 1 year .
CONCLUSIONS	( Funded by the Swedish Research Council and others ; TASTE ClinicalTrials.gov number , NCT01093404 . )

###25607909
OBJECTIVE	To evaluate efficacy of efinaconazole topical solution , 10 % in onychomycosis patients with early and long-standing disease .
METHODS	An analysis of 1655 patients , aged 18-70 years , randomized to receive efinaconazole topical solution , 10 % or vehicle from two identical multicenter , double-blind , vehicle-controlled 48-week studies evaluating safety and efficacy .
METHODS	The primary end point was complete cure rate ( 0 % clinical involvement of target toenail , and both negative potassium hydroxide examination and fungal culture ) at Week 52 .
METHODS	Three groups were compared : those with early disease ( < 1year ) , patients with a baseline disease of 1-5 years , and those with long-standing onychomycosis ( > 5years ) .
RESULTS	The majority of patients had long-standing disease ; were older , male and white .
RESULTS	While nail involvement of the target toenail did not differ noticeably amongst the three groups , the number of nails involved did increase progressively with disease duration .
RESULTS	Differences were seen in terms of infecting pathogens in early disease that might have important treatment implications .
RESULTS	Efinaconazole was more effective in treating early disease , however more than 40 % of patients with long-standing disease were considered treatment successes .
CONCLUSIONS	A period of 52 weeks may be too brief to evaluate a clinical cure in onychomycosis .
CONCLUSIONS	Treatment of onychomycosis early to avoid disease progression to other toenails is important .
CONCLUSIONS	Once daily efinaconazole topical solution , 10 % is particularly effective in these patients .

###24855368
BACKGROUND	Statins modify correlations between apolipoprotein B ( apoB ) and low-density lipoprotein cholesterol ( LDL-C ) and apoB and non-high-density lipoprotein cholesterol ( non-HDL-C ) ; however , it is not known whether niacin-based therapies have similar effects .
OBJECTIVE	To evaluate the effects of extended-release niacin ( ERN ) / laropiprant ( LRPT ) , simvastatin ( SIMVA ) , and ERN/LRPT + SIMVA ( pooled ERN/LRPT + SIMVA ) on apoB : LDL-C and apoB : non-HDL-C correlations in dyslipidemic patients .
METHODS	This post-hoc analysis of a 12-week study evaluated the apoB : LDL-C and apoB : non-HDL-C correlations in dyslipidemic patients randomized equally to double-blind ERN/LRPT 1 g/20 mg , SIMVA 10 , 20 , or 40 mg , or ERN/LRPT 1 g/20 mg + SIMVA ( 10 , 20 , or 40 mg ) once daily for 4 weeks .
METHODS	At week 5 , doses were doubled in all groups except SIMVA 40 mg ( unchanged ) and ERN/LRPT 1 g/20 mg + SIMVA 40 mg ( switched to ERN/LRPT 2 g/40 mg + SIMVA 40 mg ) .
METHODS	Simple linear regression analyses were used to calculate LDL-C and non-HDL-C levels corresponding to known apoB baseline values ( ie , in untreated patients ) and following treatment .
RESULTS	The apoB : LDL-C and apoB : non-HDL-C correlations were higher and the predicted LDL-C and non-HDL-C levels for a known apoB value were considerably lower following treatment with ERN/LRPT , SIMVA and ERN/LRPT + SIMVA compared with untreated patients at baseline .
CONCLUSIONS	Greater dissociation of apoB , LDL-C , and non-HDL-C targets occur following treatment with ERN/LRPT , SIMVA , and ERN/LRPT + SIMVA in patients with dyslipidemia .
CONCLUSIONS	The achievement of more aggressive LDL-C and non-HDL-C goals in patients receiving lipid-modifying therapy may further reduce coronary risk by normalizing apoB-containing atherogenic lipoproteins .

###24638908
OBJECTIVE	Dietary supplements have been proposed as a mechanism to improve health and prevent disease .
OBJECTIVE	To determine if supplementing diet with long-chain -3 polyunsaturated fatty acids or with macular xanthophylls results in a reduced rate of cardiovascular disease ( CVD ) .
METHODS	The Cardiovascular Outcome Study ( COS ) was an ancillary study of the Age-Related Eye Disease Study 2 ( AREDS2 ) , a factorial-designed randomized clinical trial of 4203 participants recruited from 82 US academic and community ophthalmology clinics , who were followed up for a median of 4.8 years .
METHODS	Individuals were eligible to participate if they were between the ages of 50 and 85 years , had intermediate or advanced age-related macular degeneration in 1 eye , and were willing to be randomized .
METHODS	Participants with stable , existing CVD ( > 12 months since initial event ) were eligible to participate .
METHODS	Participants , staff , and outcome assessors were masked to intervention .
METHODS	Daily supplementation with long-chain -3 polyunsaturated fatty acids ( 350-mg docosahexaenoic acid [ DHA ] + 650-mg eicosapentaenoic acid [ EPA ] ) , macular xanthophylls ( 10-mg lutein + 2-mg zeaxanthin ) , combination of the two , or matching placebos .
METHODS	These treatments were added to background therapy of the AREDS vitamin and mineral formulation for macular degeneration .
METHODS	MAIN OUTCOMES AND MEASURES A composite outcome of myocardial infarction , stroke , and cardiovascular death with 4 prespecified secondary combinations of the primary outcome with hospitalized heart failure , revascularization , or unstable angina .
RESULTS	Study participants were primarily white , married , and highly educated , with a median age at baseline of 74 years .
RESULTS	A total of 602 cardiovascular events were adjudicated , and 459 were found to meet 1 of the study definitions for a CVD outcome .
RESULTS	In intention-to-treat analysis , no reduction in the risk of CVD or secondary CVD outcomes was seen for the DHA+EPA ( primary outcome : hazard ratio [ HR ] , 0.95 ; 95 % CI , 0.78-1 .17 ) or lutein + zeaxanthin ( primary outcome : HR , 0.94 ; 95 % CI , 0.77-1 .15 ) groups .
RESULTS	No differences in adverse events or serious adverse event were seen by treatment group .
RESULTS	The sample size was sufficient to detect a 25 % reduction in CVD events with 80 % power .
CONCLUSIONS	Dietary supplementation of long-chain -3 polyunsaturated fatty acids or macular xanthophylls in addition to daily intake of minerals and vitamins did not reduce the risk of CVD in elderly participants with age-related macular degeneration .
BACKGROUND	clinicaltrials.gov Identifier : NCT00345176 .

###26095261
OBJECTIVE	To compare the outcomes of phacoemulsification with toric intraocular lens implantation vs phacoemulsification with monofocal intraocular lens implantation followed by photorefractive keratectomy ( PRK ) for correction of pre-existing astigmatism .
METHODS	Randomized controlled trial , 6-month study .
METHODS	setting : Institutional .
METHODS	Sixty eyes of 52 patients with age-related senile cataract and regular corneal astigmatism ranging from 1.50 to 3.00 diopters , enrolled and randomly allocated in 2 groups based on computer-generated random number table .
METHODS	Group 1 patients underwent phacoemulsification with toric intraocular lens ( IOL ) implantation and Group 2 patients underwent phacoemulsification with monofocal IOL implantation followed by PRK 3months later .
METHODS	The main outcome measures were uncorrected distance visual acuity ( UDVA ) , corrected distance visual acuity ( CDVA ) , residual cylinder , contrast sensitivity , glare acuity , pain score , and higher-order aberrations .
RESULTS	At 6months 53.3 % of eyes in the toric IOL and 60 % eyes in the monofocal IOL with PRK group attained UDVA of 20/20 .
RESULTS	Median residual refractive cylinder value was higher in the toric IOL group ( toric IOL = -0.5 , monofocal IOL with PRK = 0 ; P = .02 ) .
RESULTS	Mean root mean square value of total aberrations ( 5mm pupil ) was higher in monofocal IOL with PRK eyes ( toric IOL = 1.02 0.44 , monofocal IOL with PRK = 1.28 0.5 ; P = .04 ) .
RESULTS	Mean contrast sensitivity values were comparable .
RESULTS	Mean toric IOL rotation was 1.3 2.1 degrees .
RESULTS	Mean glare acuity was better in toric IOL eyes ( toric IOL = 0.46 0.16 , monofocal IOL with PRK = 0.73 0.12 ; P < .001 ) .
RESULTS	Median postoperative pain scores were higher in monofocal IOL with PRK eyes .
CONCLUSIONS	PRK yields lesser residual cylinder compared to toric IOL .
CONCLUSIONS	However , it causes greater postoperative pain and corneal aberrations , and poor glare acuity .

###25913498
BACKGROUND	Diclofenac is used for the treatment of osteoarthritis ( OA ) ; however , like other nonsteroidal anti-inflammatory drugs ( NSAIDs ) it can be associated with serious dose-related adverse events ( AEs ) .
BACKGROUND	Low-dose SoluMatrix diclofenac has been developed to provide efficacy at lower diclofenac doses .
BACKGROUND	A recently published Phase III study evaluated the efficacy and safety of SoluMatrix diclofenac 35 mg twice daily ( b.i.d. ) and thrice daily ( t.i.d. ) in patients with OA pain treated for 12 weeks .
METHODS	This Phase III multicenter , open-label study assessed the safety of SoluMatrix diclofenac in patients with OA dosed up to 52 weeks ( ClinicalTrials.gov : NCT01510912 ) .
METHODS	The study enrolled 602 chronic NSAID/acetaminophen users , aged 40 years with OA of the knee or hip .
METHODS	Patients received SoluMatrix diclofenac 35 mg b.i.d. , which could be increased to t.i.d. and subsequently reduced to b.i.d. as needed .
METHODS	Safety assessments included AEs , vital signs , physical examination findings , 12-lead electrocardiogram , and clinical laboratory test results .
METHODS	Patient-reported outcomes were evaluated by the Short Form-36 ( SF-36 ) .
RESULTS	A total of 601 patients received SoluMatrix diclofenac ; 373 of 601 patients ( 62.1 % ) received treatment for 11 months .
RESULTS	The most frequent AEs included upper respiratory tract infection , headache , urinary tract infection , diarrhea , nasopharyngitis , and nausea .
RESULTS	Serious gastrointestinal , cardiovascular , renal , and hepatic AEs were uncommon .
RESULTS	A small proportion ( 99 patients , 16.5 % ) of patients discontinued participation in the study due to AEs .
RESULTS	Clinically meaningful improvements from baseline in Physical Component Summary Scores of the SF-36 were noted at week 12 and were sustained through week 52 .
RESULTS	Improvements in six of the eight individual physical and mental SF-36 domains were also noted .
CONCLUSIONS	SoluMatrix diclofenac treatment for up to 1 year was generally well tolerated in patients with OA pain and associated with improvement in quality of life measures .
BACKGROUND	www.clinicaltrials.gov identifier : NCT01510912 .

###26132939
BACKGROUND	Obesity is a chronic disease with serious health consequences , but weight loss is difficult to maintain through lifestyle intervention alone .
BACKGROUND	Liraglutide , a glucagon-like peptide-1 analogue , has been shown to have potential benefit for weight management at a once-daily dose of 3.0 mg , injected subcutaneously .
METHODS	We conducted a 56-week , double-blind trial involving 3731 patients who did not have type 2 diabetes and who had a body-mass index ( BMI ; the weight in kilograms divided by the square of the height in meters ) of at least 30 or a BMI of at least 27 if they had treated or untreated dyslipidemia or hypertension .
METHODS	We randomly assigned patients in a 2:1 ratio to receive once-daily subcutaneous injections of liraglutide at a dose of 3.0 mg ( 2487 patients ) or placebo ( 1244 patients ) ; both groups received counseling on lifestyle modification .
METHODS	The coprimary end points were the change in body weight and the proportions of patients losing at least 5 % and more than 10 % of their initial body weight .
RESULTS	At baseline , the mean ( SD ) age of the patients was 45.112.0 years , the mean weight was 106.221.4 kg , and the mean BMI was 38.36.4 ; a total of 78.5 % of the patients were women and 61.2 % had prediabetes .
RESULTS	At week 56 , patients in the liraglutide group had lost a mean of 8.47.3 kg of body weight , and those in the placebo group had lost a mean of 2.86.5 kg ( a difference of -5.6 kg ; 95 % confidence interval , -6.0 to -5.1 ; P < 0.001 , with last-observation-carried-forward imputation ) .
RESULTS	A total of 63.2 % of the patients in the liraglutide group as compared with 27.1 % in the placebo group lost at least 5 % of their body weight ( P < 0.001 ) , and 33.1 % and 10.6 % , respectively , lost more than 10 % of their body weight ( P < 0.001 ) .
RESULTS	The most frequently reported adverse events with liraglutide were mild or moderate nausea and diarrhea .
RESULTS	Serious events occurred in 6.2 % of the patients in the liraglutide group and in 5.0 % of the patients in the placebo group .
CONCLUSIONS	In this study , 3.0 mg of liraglutide , as an adjunct to diet and exercise , was associated with reduced body weight and improved metabolic control .
CONCLUSIONS	( Funded by Novo Nordisk ; SCALE Obesity and Prediabetes NN8022-1839 ClinicalTrials.gov number , NCT01272219 . )

###25639139
BACKGROUND	Preliminary evidence suggests that improved nutrition early in HIV infection may delay progression to AIDS and delay the initiation or improve the effectiveness of antiretroviral drug therapy .
BACKGROUND	There are few studies that evaluate food-based interventions in drug-nave , HIV-infected women and their children .
BACKGROUND	Meat provides several nutrients identified as important in maintaining immune function and lean body mass .
OBJECTIVE	To design supplemental meat and soybean biscuits for use in a randomized trial examining the effect of meat in the diet of drug-nave , HIV-infected rural Kenyan women on changes in weight , lean body mass , morbidity , nutritional status , and activities of daily living of the women and growth and development of their children .
METHODS	We designed three supplemental biscuits : one with added dried beef another with added soybean flour , and a wheat biscuit to serve as a control biscuit to be used in a randomized feeding intervention in drug-nave , HIV-infected rural Kenyan women and their children .
METHODS	The nutritional contents of the different types of biscuit were examined and compared .
RESULTS	The three biscuits were isocaloric .
RESULTS	Meat biscuits provided more lysine , vitamin B12 , and bioavailable zinc .
RESULTS	Soybean biscuits provided more total and absorbable iron ; however , higher fiber and phytate contents may inhibit nutrient absorption .
RESULTS	Data analysis for clinical outcomes of the trial is ongoing .
CONCLUSIONS	The `` biscuit model '' is useful for nutrition supplementation studies because it can be provided in a blinded and randomized fashion , safely and privately in a home under directly observed consumption by a highly stigmatized population .
CONCLUSIONS	It is well received by adults and children , and the biscuits can be produced locally with available , simple , affordable technology .

###24786582
BACKGROUND	Novel interventions are needed to improve adherence to treatment in adolescents with type 1 diabetes .
BACKGROUND	In this article , we describe the development , feasibility , and acceptability of a positive psychology intervention for this population .
METHODS	Adolescents and their parents ( n = 39 ) were randomly assigned to either a positive psychology intervention or an attention control group .
METHODS	Quantitative and qualitative data were collected on feasibility and acceptability .
METHODS	Descriptive and content analysis methods were used .
RESULTS	Recruitment was successful , participation and satisfaction were high in both groups , and retention was excellent over 6months .
RESULTS	In the positive psychology group , adolescents and their parents noted benefits related to increased positive communication and thinking more about diabetes care .
RESULTS	We also identified challenges to implementation .
CONCLUSIONS	Although more research is indicated , a positive psychology framework emphasizing positive emotions and strengths , rather than problems , may be beneficial to adolescents living with a complex chronic illness .

###24283172
OBJECTIVE	To determine the effects of hormone therapy ( HT ) on ischemia modified albumin ( IMA ) and soluble ( s ) CD40 ligand in obese surgical menopausal women .
METHODS	A total of 52 obese surgical menopausal women with a body mass index ( BMI ) > 30 kg/m2 were admitted to the study .
METHODS	Twenty-seven women received estradiol hemihydrate two mg and 25 did not receive any menopausal therapy .
METHODS	At baseline and after three and six months of treatment , IMA and sCD40 ligand levels were measured .
RESULTS	There were no significant differences among the groups for any variables at baseline .
RESULTS	No difference in change in the serum sCD40L levels was found in obese surgical menopausal women after three and six months of HT .
RESULTS	Serum IMA levels were statistically lowered in obese women with HT after six months of treatment .
CONCLUSIONS	HT may have a beneficial reduction in IMA levels in obese surgical menopausal women .

###24497655
OBJECTIVE	There is uncertainty over which characteristics increase obstructive sleep apnea syndrome ( OSAS ) severity in children .
OBJECTIVE	In candidates for adenotonsillectomy ( AT ) , we evaluated the relationship of OSAS severity and age , sex , race , body mass index ( BMI ) , environmental tobacco smoke ( ETS ) , prematurity , socioeconomic variables , and comorbidities .
METHODS	Cross-sectional screening and baseline data were analyzed from the Childhood Adenotonsillectomy Trial , a randomized , controlled , multicenter study evaluating AT versus medical management .
METHODS	Regression analysis assessed the relationship between the apnea hypopnea index ( AHI ) and risk factors obtained by direct measurement or questionnaire .
METHODS	Clinical referral setting .
METHODS	Children , ages 5 to 9.9 y with OSAS .
RESULTS	Of the 1,244 children undergoing screening polysomnography , 464 ( 37 % ) were eligible ( 2 AHI < 30 or 1 obstructive apnea index [ OAI ] < 20 and without severe oxygen desaturation ) and randomized ; 129 ( 10 % ) were eligible but were not randomized ; 608 ( 49 % ) had AHI/OAI levels below entry criteria ; and 43 ( 3 % ) had levels of OSAS that exceeded entry criteria .
RESULTS	Among the randomized children , univariate analyses showed significant associations of AHI with race , BMI z score , environmental tobacco smoke ( ETS ) , family income , and referral source , but not with other variables .
RESULTS	After adjusting for potential confounders , African American race ( P = 0.003 ) and ETS ( P = 0.026 ) were each associated with an approximately 20 % increase in AHI .
RESULTS	After adjusting for these factors , obesity and other factors were not significant .
CONCLUSIONS	Apnea hypopnea index level was significantly associated with race and environmental tobacco smoke , highlighting the potential effect of environmental factors , and possibly genetic factors , on pediatric obstructive sleep apnea syndrome severity .
CONCLUSIONS	Efforts to reduce environmental tobacco smoke exposure may help reduce obstructive sleep apnea syndrome severity .
BACKGROUND	Clinicaltrials.gov ( #NCT 00560859 ) .

###24830749
BACKGROUND	Antibiotic therapy during pregnancy may be beneficial and impacts positively on the reduction of adverse pregnancy outcomes .
BACKGROUND	No studies have been done so far on the effects of daily Co-trimoxazole ( CTX ) prophylaxis on birth outcomes .
BACKGROUND	A phase 3b randomized trial was conducted to establish that daily CTX in pregnancy is not inferior to SP intermittent preventive treatment ( IPT ) in reducing placental malaria ; preventing peripheral parasitaemia ; preventing perinatal mortality and also improving birth weight .
BACKGROUND	To establish its safety on the offspring by measuring the gestational age and birth weight at delivery , and compare the safety and efficacy profile of CTX to that of SP .
METHODS	Pregnant women ( HIV infected and uninfected ) attending antenatal clinic were randomized to receive either daily CTX or sulfadoxine-pyrimethamine as per routine IPT .
METHODS	Safety was assessed using standard and pregnancy specific measurements .
METHODS	Women were followed up monthly until delivery and then with their offspring up to six weeks after delivery .
RESULTS	Data from 346 pregnant women ( CTX = 190 ; SP = 156 ) and 311 newborns ( CTX = 166 and SP = 145 ) showed that preterm deliveries ( CTX 3.6 % ; SP 3.0 % ) ; still births ( CTX 3.0 % ; SP 2.1 % ) , neonatal deaths ( CTX 0 % ; SP 1.4 % ) , and spontaneous abortions ( CTX 0.6 % ; SP 0 % ) were similar between study arms .
RESULTS	The low birth weight rates were 9 % for CTX and 13 % for SP .
RESULTS	There were no birth defects reported .
RESULTS	Both drug exposure groups had full term deliveries with similar birth weights ( mean of 3.1 Kg ) .
RESULTS	The incidence and severity of AEs in the two groups were comparable .
CONCLUSIONS	Exposure to daily CTX in pregnancy may not be associated with particular safety risks in terms of birth outcomes such as preterm deliveries , still births , neonatal deaths and spontaneous abortions compared to SP .
CONCLUSIONS	However , more data are required on CTX use in pregnant women both among HIV infected and un-infected individuals .
BACKGROUND	Clinicaltrials.gov NCT00711906 .

###24697769
OBJECTIVE	To compare the hemodynamic responses to orotracheal intubation following induction of anesthesia with propofol , ketamine-propofol , and ketamine-diazepam in premedicated dogs .
METHODS	Prospective , randomized , masked study .
METHODS	10 healthy adult Beagles .
METHODS	Dogs were randomly allocated to be anesthetized twice , with a 1-week wash-out interval , by means of 2 of 3 possible protocols ( propofol [ 4 mg/kg { 1.8 mg/lb } , n = 6 dogs ] , ketamine [ 2 mg/kg { 0.9 mg/lb } ] and propofol [ 2 mg/kg ; 7 ] , or ketamine [ 5 mg/kg { 2.3 mg/lb } ] and diazepam [ 0.2 mg/kg { 0.09 mg/lb } ; 6 ] ) .
METHODS	After instrumentation , continuous heart rate , systolic arterial blood pressure , mean arterial blood pressure , diastolic arterial blood pressure , cardiac index , stroke volume index , and systemic vascular resistance were recorded .
METHODS	Fifteen minutes after premedication , dogs were anesthetized ; all anesthetics were administered IV .
METHODS	After 5 minutes , orotracheal intubation was performed without the use of a laryngoscope .
METHODS	Data were collected prior to intubation ( baseline ) , at intubation , and 30 , 60 , 90 , 120 , 150 , and 180 seconds thereafter .
METHODS	Results were compared among the 3 groups and over time .
RESULTS	No differences among groups were observed for any variables studied .
RESULTS	In all groups , arterial blood pressures were significantly decreased at various time points after intubation .
RESULTS	A significant increase in systolic arterial blood pressure was observed between baseline and the 30-second time point in the ketamine-diazepam group .
RESULTS	No significant differences were detected over time for the other variables in any group .
CONCLUSIONS	Intubation after anesthetic induction with ketamine-diazepam caused transitory hypertension , whereas intubation after induction with propofol or ketamine-propofol did not cause cardiovascular stimulation .
CONCLUSIONS	In dogs in which hypertension is a concern , propofol or ketamine-propofol may be a better choice for induction prior to orotracheal intubation .

###26159792
OBJECTIVE	It is unknown whether women and men with acute ischemic stroke respond similar to an antioxidant regimen administered in combination with thrombolysis .
OBJECTIVE	Here , we investigated the independent effect of sex on the response to uric acid ( UA ) therapy in patients with acute stroke treated with alteplase .
METHODS	In the Efficacy Study of Combined Treatment With Uric Acid and rtPA in Acute Ischemic Stroke ( URICO-ICTUS ) trial , 206 women and 205 men were randomized to UA 1000 mg or placebo .
METHODS	In this reanalysis of the trial , the primary outcome was the rate of excellent outcome at 90 days ( modified Rankin Scale , 0-1 , or 2 , if premorbid score of 2 ) in women and men using regression models adjusted for confounders associated with sex .
METHODS	The interaction of UA levels by treatment on infarct growth was assessed in selected patients .
RESULTS	Excellent outcome occurred in 47 of 111 ( 42 % ) women treated with UA , and 28 of 95 ( 29 % ) treated with placebo , and in 36 of 100 ( 36 % ) men treated with UA and 38 of 105 ( 34 % ) treated with placebo .
RESULTS	Treatment and sex interacted significantly with excellent outcome ( P = 0.045 ) .
RESULTS	Thus , UA therapy doubled the effect of placebo to attain an excellent outcome in women ( odd ratio [ 95 % confidence interval ] , 2.088 [ 1.050-4 .150 ] ; P = 0.036 ) , but not in men ( odd ratio [ 95 % confidence interval ] , 0.999 [ 0.516-1 .934 ] ; P = 0.997 ) .
RESULTS	The interactions between treatment and serum UA levels ( P < 0.001 ) or allantoin/UA ratio ( P < 0.001 ) on infarct growth were significant only in women .
CONCLUSIONS	In women with acute ischemic stroke treated with alteplase , the administration of UA reduced infarct growth in selected patients and was better than placebo to reach excellent outcome .
BACKGROUND	URL : https://clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00860366 .

###25401161
OBJECTIVE	The aim of this study was to evaluate a light-emitting diode fluorescence tool , the SOPROLIFE light-induced fluorescence evaluator , and compare it to the international caries detection and assessment system-II ( ICDAS-II ) in the detection of occlusal caries .
METHODS	A total of 219 permanent posterior teeth in 21 subjects , with age ranging from 15 to 65 years , were examined .
METHODS	An intraclass correlation coefficient ( ICC ) was computed to assess the reliability between the two diagnostic methods .
RESULTS	The results showed a high reliability between the two methods ( ICC = 0.92 ; IC = 0.901-0 .940 ; P < 0.001 ) .
RESULTS	The SOPROLIFE blue fluorescence mode had a high sensitivity ( 87 % ) and a high specificity ( 99 % ) when compared to ICDAS-II .
CONCLUSIONS	Compared to the most used visual method in the diagnosis of occlusal caries lesions , the finding from this study suggests that SOPROLIFE can be used as a reproducible and reliable assessment tool .
CONCLUSIONS	At a cut-off point , categorizing noncarious lesions and visual change in enamel , SOPROLIFE shows a high sensitivity and specificity .
CONCLUSIONS	We can conclude that financially ICDAS is better than SOPROLIFE .
CONCLUSIONS	However SOPROLIFE is easier for clinicians since it is a simple evaluation of images .
CONCLUSIONS	Finally in terms of efficiency SOPROLIFE is not superior to ICDAS but tends to be equivalent with the same advantages .

###25124829
OBJECTIVE	Treatment failure is a common phenomenon , but little is known about the reasons .
OBJECTIVE	Therapeutic alliance , therapist adherence , and therapist competence are considered important aspects of treatment success and formed the focus of the current investigation .
METHODS	Three randomized controlled trials for the treatment of depression , social phobia , and hypochondriasis were the basis of the current study .
METHODS	The role of therapeutic alliance , as well as therapist adherence and competence , were investigated in 61 patients , which were classified either as treatment failure or as treatment success .
METHODS	Process variables were evaluated by independent raters on the basis of videotapes of the first three treatment sessions .
RESULTS	Therapists ' adherence and therapeutic alliance differed significantly between successful treatments and those classified as failures , whereas therapists ' competence did not .
RESULTS	In cross-sectional analysis , we found a moderating effect of adherence with alliance on treatment outcome , indicating that the better the therapeutic alliance , the stronger the effect of adherence on treatment outcome .
RESULTS	Moreover , higher therapists ' competence was found to affect treatment outcome positively , only mediated by therapeutic alliance .
RESULTS	Higher therapists ' adherence affected treatment outcome positively , only mediated by the competence-alliance relationship .
RESULTS	In additional longitudinal analyses , we found evidence that the therapeutic alliance within one session influences therapists ' adherence and competence in the subsequent session , but not the other way around .
CONCLUSIONS	Therapeutic alliance proved to be an important variable for the prediction of treatment failure .
CONCLUSIONS	Furthermore , in our longitudinal analyses , we found evidence that the therapeutic alliance is a precondition for the adherent and competent implementation of therapeutic techniques , which questions the results of our cross-sectional analysis and of previous research .
CONCLUSIONS	Clinical implications Treatment failure is associated with a lower therapeutic alliance in cognitive-behavioural treatment .
CONCLUSIONS	Therapeutic alliance seems to be an important precondition for the adherent and competent implementation of therapeutic techniques .
CONCLUSIONS	Therapeutic alliance should be monitored during psychotherapeutic treatment .
CONCLUSIONS	Cautions or limitations Results are limited to cognitive-behavioural therapy and may not be representative for other treatment approaches .
CONCLUSIONS	Process analyses are based on highly standardized randomized controlled trials and may not be generalizable to routine care .

###24906586
OBJECTIVE	Our aim was to explore the effectiveness of energy healing , a commonly used complementary and alternative therapy , on well-being in cancer patients while assessing the possible influence on the results of participating in a randomized controlled trial .
METHODS	247 patients treated for colorectal cancer ( response rate : 31.5 % ) were either ( a ) randomized to healing ( RH ) or control ( RC ) or ( b ) had self selected the healing ( SH ) or control condition ( SC ) , and completed questionnaires assessing well-being ( QoL , depressive symptoms , mood , and sleep quality ) , attitude toward complementary and alternative medicine ( CAM ) , and faith/spirituality at baseline , 1 week , and 2 months post-intervention .
METHODS	They also indicated , at baseline , whether they considered QoL , depressive symptoms , mood , and sleep quality as important outcomes to them .
RESULTS	Multilevel linear models revealed no overall effect of healing on QoL ( p = 0.156 ) , depressive symptoms ( p = 0.063 ) , mood ( p = 0.079 ) , or sleep quality ( p = 0.346 ) in the intervention groups ( RH , SH ) compared with control ( SC ) .
RESULTS	Effects of healing on mood were only found for patients who had a positive attitude toward CAM and considered the outcome in question as important ( SH : Regression coefficient : -8.78 ; SE : 2.64 ; CI : -13.96 to -3.61 ; p = 0.001 , and RH : Regression coefficient -7.45 ; SE : 2.76 ; CI : -12.86 to -2.04 ; p = 0.007 ) .
CONCLUSIONS	Whereas it is generally assumed that CAMs such as healing have beneficial effects on well-being , our results indicated no overall effectiveness of energy healing on QoL , depressive symptoms , mood , and sleep quality in colorectal cancer patients .
CONCLUSIONS	Effectiveness of healing on well-being was , however , related to factors such as self-selection and a positive attitude toward the treatment .

###25196239
OBJECTIVE	The aim of this paper is to report a pilot study in which participants who had recently received a diagnosis of dementia were randomised to either a 10-week group intervention or a waiting-list control .
METHODS	Memory clinic staff with limited previous experience of group therapy were trained to lead a 10-week group therapy intervention called ` Living Well with Dementia ' .
METHODS	Fifty-eight participants , all of whom had received a diagnosis of Alzheimer 's disease , vascular or Lewy body dementia within the previous 18 months , were randomised to receive either the intervention or treatment as usual ( waiting-list control ) .
METHODS	Data collection occurred at baseline , within two weeks after the intervention finished and at 10-week follow-up .
RESULTS	The study met its recruitment targets , with a relatively low attrition rate for the intervention arm .
RESULTS	The acceptability of the intervention and research methods was examined qualitatively and will be reported on elsewhere .
RESULTS	For the primary outcome , measure of quality of life in Alzheimer 's disease ( QoL-AD ) , and secondary outcome , self-esteem , there was some evidence of improvement in the intervention group compared to the control group .
RESULTS	There was , also , evidence of a reduction in cognitive functioning in the treatment group compared to the control .
RESULTS	Such reported differences should be treated with caution because they are obtained from a pilot and not a definitive study .
CONCLUSIONS	This pilot study succeeded in collecting data to inform a future definitive cost effectiveness clinical trial of Living Well with Dementia group therapy .

###24665971
OBJECTIVE	This study aimed to evaluate the fluoride concentration in the fingernails and toenails of children aged 18-30 months during use of fluoride-containing toothpastes supplemented with calcium glycerophosphate ( CaGP ) or sodium trimetaphosphate ( TMP ) .
METHODS	According to the toothpaste used , children ( n = 56 ) were randomly assigned into three groups : 500 g F/g with 1 % TMP , 500 g F/g with 0.25 % CaGP , and 1100 g F/g .
METHODS	Fingernails and toenails were collected monthly over a period of 330 days , from the beginning of toothpaste use .
METHODS	Fluoride concentration in the water consumed by the volunteers and fluoride intake from diet and toothpaste were also determined .
METHODS	Fluoride analyses were performed with the electrode after hexamethyldisiloxane-facilitated diffusion or by the direct method , according to the samples .
METHODS	Data passed normality and homoscedasticity tests and were analyzed by 2-way analysis of variance ( anova ) and 1-way anova followed by Student-Newman-Keuls test ( P < 0.05 ) .
RESULTS	Fluoride levels in the fingernails and toenails as well as fluoride intake from toothpaste were similar for the groups treated with 500 g F/g with 1 % TMP and 500 g F/g with 0.25 % CaGP toothpastes , but significantly lower than the 1100 g F/g group ( P < 0.05 ) .
RESULTS	No significant differences were noted among the groups regarding fluoride intake from diet and that by water consumed by the volunteers ( P > 0.05 ) .
CONCLUSIONS	The results of the longitudinal study suggest that the level of fluoride present in nails was lower with the use of toothpastes with a low fluoride concentration .

###24269858
BACKGROUND	Despite common use of intraoperative electrophysiologic neuromonitoring , injuries to the lumbar plexus during lateral lumbar interbody fusion ( LLIF ) have been reported .
BACKGROUND	Emerging data suggest that recombinant human bone morphogenetic protein-2 ( rhBMP-2 ) use during an anterior or transforaminal lumbar interbody fusion may be associated with an increased risk of neurological deficit .
BACKGROUND	Clinical data on the sequelae of rhBMP-2 implantation in close proximity to the lumbosacral plexus during LLIF remains to be understood .
OBJECTIVE	The purpose of this study was to compare the incidence of neurologic deficits and pain in patients undergoing LLIF with and without rhBMP-2 .
METHODS	Retrospective outcome analysis in controlled cohorts undergoing the lateral exposure technique for LLIF with and without rhBMP-2 .
METHODS	The electronic medical records of patients undergoing LLIF with and without supplemental posterior fusion for degenerative spinal conditions were retrospectively reviewed over a 6-year period .
METHODS	Patients with previous lumbar spine surgery or follow-up of less than 6 months were excluded .
METHODS	Patients were divided into 2 groups , Group 1 ( rhBMP-2 use ; n = 72 ) and Group 2 ( autograft/allograft use ; n = 72 ) , and were matched according to the age at the time of surgery , gender , weight , body mass index , side of approach , total number of treated spinal segments , use of supplemental posterior fusion , and length of follow-up .
RESULTS	Immediately after surgery , a sensory deficit was recorded in 33 patients in Group 1 and 35 patients in Group 2 ( odds ratio [ OR ] 0.895 ; 90 % confidence interval [ CI ] 0.516-1 .550 ; p = .739 ) .
RESULTS	At last follow-up , a persistent sensory deficit was identified in 29 patients whose LLIF procedure was supplemented by rhBMP-2 and 20 patients in whom autograft/allograft was used ( OR 1.754 ; 90 % CI 0.976-3 .151 ; p = .115 ) .
RESULTS	A motor deficit was recorded in 37 patients immediately after the rhBMP-2 procedure and 28 patients treated with autograft/allograft ( OR 1.661 ; 90 % CI 0.953-2 .895 ; p = .133 ) .
RESULTS	A persistent motor deficit was recorded in 35 and 17 patients in Groups 1 and 2 , respectively , at last follow-up ( OR 3.060 ; 90 % CI 1.681-5 .571 ; p = .002 ) .
RESULTS	During the first postoperative examination , 37 patients in Group 1 and 25 patients in Group 2 complained of anterior thigh or groin pain ( OR 1.987 ; 90 % CI 1.133-3 .488 ; p = .045 ) .
RESULTS	At last follow-up , there was a significantly higher number of patients in Group 1 who complained of persistent anterior thigh or groin pain than Group 2 ( 8 vs. 0 patients ) ( OR 16.470 ; 90 % CI 1.477-183 .700 ; p = .006 ) .
CONCLUSIONS	Our results provide evidence of an increased rate of postoperative neurologic deficit and anterior thigh/groin pain after LLIF using rhBMP-2 , when compared with matched controls without rhBMP-2 exposure .
CONCLUSIONS	This study suggests a potential direct deleterious effect of rhBMP-2 on the lumbosacral plexus .

###24252795
OBJECTIVE	To examine whether larger bowls bias children toward requesting more food from the adults who serve them .
METHODS	Study 1 was a between-subject design involving 69 preschool-age children who were randomized to receive either a small ( 8 oz ) or large ( 16 oz ) cereal bowl and were asked to tell researchers how much cereal they wanted for a morning snack .
METHODS	Study 2 was a within-subject design involving 18 school-age children at a summer camp who were given a small ( 8 oz ) cereal bowl on one day and a large ( 16 oz ) cereal bowl on another day and asked by a cafeteria server how much cereal and milk they wanted for breakfast .
METHODS	Hidden scales measured how much cereal and milk were served , consumed , and wasted .
METHODS	Body mass index was calculated at the end of the study .
RESULTS	In study 1 , the young children requested almost twice as much cereal to eat when presented with the larger bowl compared with the smaller bowl .
RESULTS	In study 2 , the older children consumed 52 % more and wasted 26 % more when served in the larger bowl .
CONCLUSIONS	A step toward potentially reducing overeating and waste would be for parents and adult caregivers to use smaller bowls for serving food to children .

###25266601
BACKGROUND	Predicting fluid responsiveness is crucial for fluid administration in septic shock patients .
BACKGROUND	Midazolam and propofol decrease vascular tone and venous return , which may influence preload dependency .
BACKGROUND	However , little is known about the effects of these two sedatives on preload dependency in septic shock patients .
BACKGROUND	We evaluated the effects of sedation with propofol or midazolam on preload dependency in septic shock patients who have been fluid resuscitated .
METHODS	Forty-three septic shock patients who were undergoing early goal-directed therapy resuscitated within 24 h were enrolled .
METHODS	The patients were randomly divided into the midazolam group and the propofol group .
METHODS	An initial passive leg-raising test ( PLR1 ) was performed to evaluate passive leg raising test ( PLR ) responsiveness .
METHODS	Then , the patients were infused with midazolam or propofol .
METHODS	After increasing the doses of the sedatives to titrate to a Ramsay 4 score , a second passive leg raising test ( PLR2 ) was conducted to evaluate PLR responsiveness .
METHODS	The primary end-point was the preload dependency before and after sedation with midazolam or propofol .
RESULTS	In the midazolam-PLR1-negative patients , there was no difference between the changes in the cardiac index induced by PLR1 ( PLR1 - cardiac function index [ CI ] ) and the changes in the cardiac index induced by PLR2 ( PLR2 - CI ) ( +1.4 % 7.4 % versus +1.7 % 6.4 % , P > 0.05 ) .
RESULTS	However , in the propofol-PLR1-negative patients , there was a significant increase in the PLR - CI after sedation to a Ramsay 4 score compared with a Ramsay 3 score ( +7.3 % 4.8 % versus +3.2 % 4.7 % , P = 0.008 ) .
RESULTS	There were no differences between PLR1 - CI and PLR2 - CI within the midazolam-PLR1-positive patients or within the propofol-PLR1-positive patients .
CONCLUSIONS	In titrating the sedation level from a Ramsay 3 score to a Ramsay 4 score , propofol but not midazolam increased preload dependency in septic shock patients with fluid nonresponsiveness .

###25417405
OBJECTIVE	This study used gated myocardial perfusion imaging ( G-MPI ) to assess the clinical value of Xinmailong injection in chronic congestive heart failure ( CHF ) .
METHODS	A total of 102 CHF patients were randomly divided into the control group ( n = 51 ) and the Xinmailong group ( n = 51 ) .
METHODS	Patients in the control group were routinely treated .
METHODS	Patients in the Xinmailong group were additionally treated with Xinmailong injection in addition to routine treatment .
METHODS	Before and 3 months after treatment , G-MPI was used to determine changes in the left ventricular ejection fraction ( LVEF ) , left ventricular end-diastolic volume ( LVEDV ) and left ventricular end-systolic volume ( LVESV ) .
METHODS	Fourteen days after treatment , changes in plasma brain natriuretic peptide ( BNP ) levels were determined .
RESULTS	Before treatment , there were no significant differences in LVEF , LVEDV , LVESV , and BNP levels between the two groups ( all P > 0.05 ) .
RESULTS	After treatment , LVEDV , LVESV , and BNP levels were significantly lower , and LVEF was significantly higher in the Xinmailong group than in the control group ( all P < 0.05 ) .
CONCLUSIONS	Additional use of Xinmailong injection in addition to routine treatment improves cardiac function of CHF patients .
CONCLUSIONS	Because of the safety and effectiveness of Xinmailong injection ; this therapy should be promoted .

###24462367
OBJECTIVE	Cocoa flavanols are recognised by their favourable antioxidant and vascular effects .
OBJECTIVE	This study investigates the influence on health of the daily consumption of ready-to-eat meals supplemented with cocoa extract within a hypocaloric diet , on middle-aged overweight/obese subjects .
RESULTS	Fifty healthy male and female middle-aged volunteers [ 57.265.24 years and body mass index ( BMI ) 30.592.33 kg/m ( 2 ) ] were recruited to participate in a 4 week randomised , parallel and double-blind study .
RESULTS	After following 3 days on a low-polyphenol diet , 25 volunteers received meals supplemented with 1.4 g of cocoa extract ( 645.3 mg of polyphenols ) and the other 25 participants received control meals , within a 15 % energy restriction diet .
RESULTS	On the 4th week of intervention individuals in both dietary groups improved ( p < 0.05 ) anthropometric , body composition , blood pressure and blood biochemical measurements .
RESULTS	Oxidised LDL cholesterol ( oxLDL ) , showed a higher reduction ( p = 0.030 ) in the cocoa group .
RESULTS	Moreover , myeloperoxidase ( MPO ) levels decreased only in the cocoa supplemented group ( p = 0.007 ) .
RESULTS	Intercellular Adhesion Molecule-1 ( sICAM-1 ) decreased significantly in both groups , while Vascular Cell Adhesion Molecule-1 ( sVCAM-1 ) did not present differences after the 4 weeks of intervention .
RESULTS	Interestingly , cocoa intake showed a different effect by gender , presenting more beneficial effects in men .
CONCLUSIONS	The consumption of cocoa extract as part of ready-to-eat meals and within a hypocaloric diet improved oxidative status ( oxLDL ) in middle-aged subjects , being most remarkable in males .
BACKGROUND	Registered at www.clinicaltrials.gov ( NCT01596309 ) .

###24258020
OBJECTIVE	The purpose of the study was to evaluate whether the biomembrane made of cartilage extracellular matrix , designed to provide cartilage-like favourable environments as well as to prevent against washout of blood clot after microfracture , would enhance cartilage repair compared with the conventional microfracture technique .
METHODS	A prospective trial was designed to compare the biomembrane cover after microfracture with conventional microfracture among patients with grade III-IV symptomatic cartilage defect in the knee joint .
METHODS	Patients aged 18-60 years were assigned to either the microfracture/biomembrane ( n = 45 ) or microfracture groups ( n = 19 ) .
METHODS	Among them , 24 knees in the microfracture/biomembrane and 12 knees in the microfracture were followed up for 2 years .
METHODS	Cartilage repair was assessed with magnetic resonance imagings taken 6 months , 1 year , and 2 years postoperatively , and the clinical outcomes were also recorded .
RESULTS	Compared with conventional microfracture , microfracture/biomembrane resulted in greater degree of cartilage repair ( p = 0.043 ) .
RESULTS	In the intra-group analysis , while microfracture showed moderate to good degree of cartilage repair in nearly 50 % of the patients ( 47 % at 6 months to 50 % at 2 years ; n.s. ) , microfracture/biomembrane maintained an equivalent degree of repair up to 2 years ( 88 % at 6 months to 75 % at 2 years ; n.s. ) .
RESULTS	The clinical outcome at 2 years also showed improved knee score and satisfaction and decreased pain in each group , but the difference between the two groups was not statistically significant .
CONCLUSIONS	Compared with conventional microfracture , biomembrane cover after microfracture yielded superior outcome in terms of the degree of cartilage repair during 2 years of follow-up .
CONCLUSIONS	This implies that initial protection of blood clot and immature repair tissue at the microfractured defect is important for the promotion of enhanced cartilage repair , which may be obtained by the application of a biomembrane .
METHODS	Prospective comparative study , Level II .

###24548338
BACKGROUND	Remote ischaemic pre-conditioning attenuates myocardial injury .
BACKGROUND	Because sulphonylurea drugs interfere with ischaemic and anaesthetic pre-conditioning , we assessed whether remote ischaemic pre-conditioning effects are altered in sulphonylurea-treated diabetics .
METHODS	Using the database of our ongoing randomised , placebo-controlled study ( ClinicalTrials.gov NCT01406678 ) , we assessed the troponin I concentration area under curve ( measurements : baseline , 1 , 6 , 12 , 24 , 48 , and 72 h post-operatively ) in sulphonylurea-treated diabetics ( n = 27 ) and non-diabetics ( n = 230 ) without and with remote ischaemic pre-conditioning ( three 5-min periods of left upper arm ischaemia with 5-min reperfusion each ) during isoflurane anaesthesia before two - to three-vessel coronary artery surgery .
RESULTS	Remote ischaemic pre-conditioning in non-diabetic patients evoked a 41 % decrease in the troponin I concentration area under curve ( 514 ng/ml 72 h 600 vs. 302 190 , P = 0.001 ) but no change ( 404 ng/ml 72 h 224 vs. 471 383 , P = 0.62 ) in sulphonylurea-treated diabetics .
RESULTS	There was no significant correlation between the troponin I concentration area under curve and arterial glucose concentrations , and the latter was not an independent confounder .
CONCLUSIONS	Cardioprotection by remote ischaemic pre-conditioning during isoflurane anaesthesia is abolished in sulphonylurea-treated diabetics .

###25249652
OBJECTIVE	Treatment algorithms for type 2 diabetes recommend weight loss for disease management .
OBJECTIVE	The safety and efficacy of treatment with phentermine ( PHEN ) / topiramate ( TPM ) extended release ( ER ) plus lifestyle modification for weight loss and glycemic benefits were assessed in two randomized , double-blind , placebo-controlled 56-week studies of obese/overweight adults with type 2 diabetes .
METHODS	The OB-202 / DM-230 Study was a 56-week phase 2 trial that randomized subjects to receive once-daily placebo or PHEN/TPM ER 15 mg/92 mg ( 15/92 ) .
METHODS	The primary end point was change in HbAc level .
METHODS	A post hoc analysis of a subpopulation with type 2 diabetes from a second study , CONQUER , is also presented .
METHODS	All subjects made lifestyle modifications , and comorbidities were managed to the standard of care .
RESULTS	The study groups comprised 130 subjects with type 2 diabetes enrolled in the OB-202 / DM-230 Study ( mean baseline HbAc 8.7 % [ 72 mmol/mol ] ) and 388 subjects with type 2 diabetes in the CONQUER Study ( mean baseline HbA1c 6.8 % [ 51 mmol/mol ] ) .
RESULTS	At week 56 in the OB-202 / DM-230 , change in weight ( from intent-to-treat sample with last observation carried forward [ ITT-LOCF ] ) was -2.7 % for placebo and -9.4 % for PHEN/TPM ER 15/92 ( P < 0.0001 vs. placebo ) .
RESULTS	Change in HbA1c level ( from ITT-LOCF ) was -1.2 % ( -13.1 mmol/mol ) for placebo and -1.6 % ( -17.5 mmol/mol ) for PHEN/TPM ER 15/92 ( P = 0.0381 ) .
RESULTS	In both the OB-202 / DM-230 and CONQUER , greater numbers of patients randomized to receive PHEN/TPM ER treatment achieved HbAc targets with reduced need for diabetic medications when compared with the placebo group .
RESULTS	Common adverse events included paraesthesia , constipation , and insomnia .
CONCLUSIONS	PHEN/TPM ER plus lifestyle modification can effectively promote weight loss and improve glycemic control as a treatment approach in obese/overweight patients with type 2 diabetes .

###25675063
OBJECTIVE	To determine the effects of SGB in BCRL patients and the efficacy of corticosteroids in SGB .
METHODS	A double-blinded , randomized , controlled trial .
METHODS	A single academic hospital , outpatient setting .
METHODS	In total , 32 patients with BCRL were recruited .
METHODS	Patients were divided randomly into 3 groups ( Group A : 0.5 % bupivacaine 5 mL , n = 12 ; Group B : 0.5 % bupivacaine 4.5 mL + 20 mg of triamcinolone 0.5 mL , n = 10 ; and Group C : 0.5 % bupivacaine 4 mL + 40 mg of triamcinolone 1 mL , n = 10 ) .
METHODS	All patients received 3 consecutive SGBs , every 2 weeks .
METHODS	The primary outcomes were changes in forearm and upper arm circumference .
METHODS	Circumference was measured at baseline , 2 weeks ( before the second injection ) , 4 weeks ( before the third injection ) , and 8 weeks ( one month follow-up after 3 consecutive SGBs ) .
METHODS	Moreover , subjective data were collected using EORTC C-30 at baseline and 8 weeks .
RESULTS	After 3 consecutive SGBs , forearm and upper arm circumferences were decreased significantly from baseline in all groups ( P < 0.05 / 3 ) .
RESULTS	The upper arm circumference of group C was reduced significantly more than that of group A ( P < 0.05 / 3 ) .
RESULTS	The subjective data by EORTC-C30 at baseline and one month after 3 consecutive SGBs revealed no statistically significant difference .
CONCLUSIONS	Relatively few patients were enrolled .
CONCLUSIONS	We did not compare SGB with any other BCRL treatment , such as complex decongestive therapy .
CONCLUSIONS	This study suggests that SGB may be an effective treatment for BCRL .
CONCLUSIONS	Furthermore , it appears that corticosteroids could have an additive effect in SGB .

###24768960
OBJECTIVE	To compare reduction of pain after laparoscopy for ablation or excision of endometriosis .
METHODS	Prospective , randomized , double-blind study ( Canadian Task Force classification I ) .
METHODS	Endometriosis and pelvic pain clinic at a university teaching hospital .
METHODS	Women of reproductive age with pelvic pain and visually proved endometriosis .
METHODS	Subjects completed a questionnaire rating various kinds of pain using visual analog scales ( VAS ) .
METHODS	After visual identification subjects were randomized to treatment via ablation or excision by supervised training gynecologists as primary surgeons .
METHODS	Follow-up questionnaires documented pain levels every 3 months for 1 year and then every 6 months for 5 years .
RESULTS	Change in pain VAS scores during 5 years after the operation and rates of pregnancy , repeat surgery , and use of hormone therapy were evaluated .
RESULTS	There was a reduction in all pain scores over the 5-year follow-up in both treatment groups .
RESULTS	A significantly greater reduction in dyspareunia VAS scores was observed in the excision group at 5 years ( p = .03 at univariate analysis , and p = .007 at multivariate analysis ) .
RESULTS	More women in the ablation group continued to receive medical treatment of endometriosis at 5 years ( p = .004 ) .
CONCLUSIONS	Surgical treatment of endometriosis provides symptom reduction for up to 5 years .
CONCLUSIONS	In some limited areas such as deep dyspareunia , excision is more effective than ablation .

###24391767
BACKGROUND	The purpose of the present study was to compare the image quality of spinal magnetic resonance ( MR ) imaging performed on a high-field horizontal open versus a short-bore MR scanner in a randomized controlled study setup .
METHODS	Altogether , 93 ( 80 % women , mean age 53 ) consecutive patients underwent spine imaging after random assignement to a 1-T horizontal open MR scanner with a vertical magnetic field or a 1.5-T short-bore MR scanner .
METHODS	This patient subset was part of a larger cohort .
METHODS	Image quality was assessed by determining qualitative parameters , signal-to-noise ( SNR ) and contrast-to-noise ratios ( CNR ) , and quantitative contour sharpness .
RESULTS	The image quality parameters were higher for short-bore MR imaging .
RESULTS	Regarding all sequences , the relative differences were 39 % for the mean overall qualitative image quality , 53 % for the mean SNR values , and 34-37 % for the quantitative contour sharpness ( P < 0.0001 ) .
RESULTS	The CNR values were also higher for images obtained with the short-bore MR scanner .
RESULTS	No sequence was of very poor ( nondiagnostic ) image quality .
RESULTS	Scanning times were significantly longer for examinations performed on the open MR scanner ( mean : 3222 min versus 209 min ; P < 0.0001 ) .
CONCLUSIONS	In this randomized controlled comparison of spinal MR imaging with an open versus a short-bore scanner , short-bore MR imaging revealed considerably higher image quality with shorter scanning times .
BACKGROUND	ClinicalTrials.gov NCT00715806 .

###24658390
OBJECTIVE	To evaluate the effectiveness of a telephone-delivered behavioral weight loss and physical activity intervention targeting Australian primary care patients with type 2 diabetes .
METHODS	Pragmatic randomized controlled trial of telephone counseling ( n = 151 ) versus usual care ( n = 151 ) .
METHODS	Reported here are 18-month ( end-of-intervention ) and 24-month ( maintenance ) primary outcomes of weight , moderate-to-vigorous-intensity physical activity ( MVPA ; via accelerometer ) , and HbA1c level .
METHODS	Secondary outcomes include dietary energy intake and diet quality , waist circumference , lipid levels , and blood pressure .
METHODS	Data were analyzed via adjusted linear mixed models with multiple imputation of missing data .
RESULTS	Relative to usual-care participants , telephone counseling participants achieved modest , but significant , improvements in weight loss ( relative rate [ RR ] -1.42 % of baseline body weight [ 95 % CI -2.54 to -0.30 % of baseline body weight ] ) , MVPA ( RR 1.42 [ 95 % CI 1.06-1 .90 ] ) , diet quality ( 2.72 [ 95 % CI 0.55-4 .89 ] ) , and waist circumference ( -1.84 cm [ 95 % CI -3.16 to -0.51 cm ] ) , but not in HbA1c level ( RR 0.99 [ 95 % CI 0.96-1 .02 ] ) , or other cardio-metabolic markers .
RESULTS	None of the outcomes showed a significant change/deterioration over the maintenance period .
RESULTS	However , only the intervention effect for MVPA remained statistically significant at 24 months .
CONCLUSIONS	The modest improvements in weight loss and behavior change , but the lack of changes in cardio-metabolic markers , may limit the utility , scalability , and sustainability of such an approach .

###25468575
OBJECTIVE	To determine if prewarming of the i-gel ( Intersurgical , Wokingham , United Kingdom ) improves insertion and ventilation efficacy with muscle relaxation in patients undergoing elective surgery .
METHODS	Clinical randomized study .
METHODS	Operating room .
METHODS	Sixty-eight adult patients scheduled for elective surgery under general anesthesia with American Society of Anesthesiologists physical status 1-3 .
METHODS	The i-gel was warmed to 42C for 30 minutes before insertion ( W group ; 34 patients ) or kept at room temperature ( approximately 23C ) ( C group ; 34 patients ) .
METHODS	The number of attempts for a successful insertion and the sealing pressure and leak volume 30 seconds and 30 minutes after initiating mechanical ventilation .
RESULTS	The total insertion attempts were 1 ( W group , 31 cases ; C group , 24 cases ) and 2 ( W group , 3 cases ; C group , 10 cases ) , which was significant ( P = .001 ) .
RESULTS	Sealing pressure was significantly higher in the W group than the C group ( W group , 21.8 3.7 cm H2O ; C group , 18.5 3.4 cm H2O ; P = .001 ) .
RESULTS	Leak volume was significantly smaller after 30 seconds in the W group than the C group ( P = .002 ) , but not after 30 minutes ( P = .69 ) .
CONCLUSIONS	Prewarming the i-gel to 42C demonstrated a higher successful ventilation initiation .

###25789814
BACKGROUND	Patterns of crow 's feet lines ( CFLs ) vary among individuals .
OBJECTIVE	To characterize distribution and predictors of CFL patterns .
METHODS	Patterns of CFLs ( full fan , lower fan , central fan , and upper fan ) were evaluated at maximum smile and at rest from photographs of subjects with moderate-to-severe CFLs .
METHODS	Relationships between CFL pattern and severity , age , gender , and subject-reported outcomes were explored .
RESULTS	Evaluations of 2,699 photographs from 1,392 subjects were conducted ; 1,389 and 1,310 had evaluable CFL patterns at maximum smile and at rest , respectively .
RESULTS	Lower-fan , central-fan , and full-fan patterns were identified in 28.4 % to 34.7 % at maximum smile and 27.7 % to 33.9 % at rest ; upper fan was found in 5 % .
RESULTS	The pattern distribution of CFLs demonstrated a relationship to baseline CFL severity , age , and gender ; full-fan and lower-fan patterns were more common in severe versus moderate CFL at maximum smile ; full fan increased with age .
RESULTS	Lower fan was more common in males .
RESULTS	Subjects with full fan at maximum smile were most dissatisfied with their appearance and perceived themselves to look older versus other patterns .
CONCLUSIONS	Baseline CFL severity , age , and gender may predict fan pattern .
CONCLUSIONS	Patterns may progress with age from central to lower fan or full fan .
CONCLUSIONS	Pattern heterogeneity of CFLs suggests that tailored treatment may be warranted .

###25706092
OBJECTIVE	Patients co-infected with human immunodeficiency virus ( HIV ) and hepatitis C virus ( HCV ) are at high risk for liver disease progression .
OBJECTIVE	However , interferon-based treatments for HCV infection have significant toxicities , limiting treatment uptake .
OBJECTIVE	To assess the all-oral 3 direct-acting antiviral ( 3D ) regimen of ombitasvir , paritaprevir ( co-dosed with ritonavir [ paritaprevir/r ] ) , dasabuvir , and ribavirin in HCV genotype 1-infected adults with HIV-1 co-infection , including patients with cirrhosis .
METHODS	TURQUOISE-I is a randomized , open-label study .
METHODS	Part 1a of this pilot study was conducted at 17 sites in the United States and Puerto Rico between September 2013 and August 2014 and included 63 patients with HCV genotype 1 and HIV-1 co-infection who were HCV treatment-naive or had history of prior treatment failure with peginterferon plus ribavirin therapy .
METHODS	The study allowed enrollment of patients , including those with cirrhosis , with a CD4 + count of 200/mm3 or greater or CD4 + percentage of 14 % or more and plasma HIV-1 RNA suppressed while taking a stable atazanavir - or raltegravir-inclusive antiretroviral regimen .
METHODS	Ombitasvir/paritaprevir/r , dasabuvir , and ribavirin for 12 or 24 weeks of treatment as randomized .
METHODS	The primary assessment was the proportion of patients with sustained virologic response ( HCV RNA < 25 IU/mL ) at posttreatment week 12 ( SVR12 ) .
RESULTS	Among patients receiving 12 or 24 weeks of 3D and ribavirin , SVR12 was achieved by 29 of 31 ( 94 % ; 95 % CI , 79 % -98 % ) and 29 of 32 patients ( 91 % ; 95 % CI , 76 % -97 % ) , respectively .
RESULTS	Of the 5 patients who did not achieve SVR , 1 withdrew consent , 2 had confirmed virologic relapse or breakthrough , and 2 patients had clinical history and phylogenetic evidence consistent with HCV reinfection .
RESULTS	The most common treatment-emergent adverse events were fatigue ( 48 % ) , insomnia ( 19 % ) , nausea ( 18 % ) , and headache ( 16 % ) .
RESULTS	Adverse events were generally mild , with none reported as serious or leading to discontinuation .
RESULTS	No patient had a confirmed HIV-1 breakthrough of 200 copies/mL or greater during treatment .
CONCLUSIONS	In this open-label , randomized uncontrolled study , treatment with the all-oral , interferon-free 3D-plus-ribavirin regimen resulted in high SVR rates among patients co-infected with HCV genotype 1 and HIV-1 whether treated for 12 or 24 weeks .
CONCLUSIONS	Further phase 3 studies of this regimen are warranted in patients with co-infection .
BACKGROUND	clinicaltrials.gov Identifier : NCT01939197 .

###24919684
BACKGROUND	Fluid retention is a common complication of critical illness .
BACKGROUND	It typically results from large-volume fluid infusions during acute resuscitation and is worsened by hypoalbuminemia .
BACKGROUND	Recognized as edema , fluid retention is important for its association with delayed weaning and increased mortality .
BACKGROUND	The standard treatment is the administration of diuretics , with or without albumin .
BACKGROUND	We hypothesize that intravenous 25 % albumin plus furosemide , by comparison with furosemide alone , improves diuresis , oxygenation , and hemodynamic stability in the deresuscitation of critically ill , hypoalbuminemic patients .
BACKGROUND	We propose a pilot study to determine the feasibility of a trial to investigate this hypothesis .
METHODS	FADE is a single-center , parallel , pilot randomized controlled trial .
METHODS	We aim to allocate 50 hemodynamically stable , hypoalbuminemic adult patients receiving diuresis to treatment with either 100 ml of either 25 % albumin or normal saline placebo twice daily , for a total of six doses .
METHODS	Diuretics are to be prescribed by the caregiving team at least twice daily , and administered within 2 hours following study treatment .
METHODS	Patients , intensive care unit ( ICU ) clinicians , data collectors , and outcome adjudicators will be blinded to treatment allocation .
METHODS	Feasibility outcome measures include the proportion of patients receiving albumin within 2 hours of diuretic , the proportion of patients receiving the full six doses of study treatment , the proportion of patients who receive open label 25 % albumin , and the rate of recruitment .
METHODS	Physiologic , laboratory , and clinical data are collected until discharge from the ICU or until 30 days .
CONCLUSIONS	This is the first randomized trial to assess the use of hyperoncotic albumin in addition to diuretics in a general ICU population .
CONCLUSIONS	Should this pilot study demonstrate feasibility , the primary outcome measure of the larger clinical trial will be the number of ventilator-free days , with secondary clinical outcome measures of duration of mechanical ventilation , length of ICU stay , episodes of hemodynamic instability and mortality .
CONCLUSIONS	The addition of 25 % albumin to standard diuretic therapy is a promising treatment in the post-resuscitation care of the critically ill patient .
BACKGROUND	ClinicalTrials.gov NCT02055872 ; ISRCTN70191881 .

###24361805
BACKGROUND	Pulmonary hypertension due to left heart disease is very common .
BACKGROUND	Our aim was to investigate the relationship of the severity of left ventricular diastolic dysfunction with precapillary and postcapillary pulmonary hypertension ( PH ) in an elderly heart failure ( HF ) population .
RESULTS	A post hoc analysis of the Trial of Intensified Medical Therapy in Elderly Patients With Congestive Heart Failure data was done .
RESULTS	Baseline transthoracic echocardiography was used to categorize diastolic function , estimate pulmonary artery pressure and pulmonary capillary wedge pressure , and calculate the transpulmonary pressure gradient ( TPG ) .
RESULTS	Among 392 HF patients , PH was present in 31 % of patients with grade 1 , in 37 % of patients with grade 2 , and in 65 % of patients with grade 3 diastolic dysfunction ; 54 % of all HF patients with PH had a TPG > 12 mm Hg , suggesting not only a postcapillary but also an additional precapillary component of PH. Survival was not related to the severity of diastolic dysfunction , but was worse in patients with PH ( hazard ratio 1.63 , 95 % confidence interval 1.07-2 .51 ; P = .024 ) .
CONCLUSIONS	Our data indicate that HF patients with even mild diastolic dysfunction often have PH. Echocardiographic assessment suggest that the presence of PH might not simply be due to increased PCWP , but in part due to a precapillary component .

###25324277
OBJECTIVE	There is growing evidence from experimental studies that the acupuncture dose or technique influences the speed of onset of hypoalgesia .
OBJECTIVE	The aim of this study was to investigate the effects of acupuncture using two or four needles on experimental contact thermal pain in healthy volunteers .
METHODS	Forty two participants were randomised into three groups : four-needle group ( LI4 , LI11 , LI10 , TE5 ) , two-needle group ( verum at LI4 , LI11 and mock at LI10 , TE5 ) and mock acupuncture group ( LI4 , LI11 , LI10 , TE5 ) .
METHODS	Each participant rated pain intensity ( visual analogue scale , VAS ) to a series of noxious stimuli administered to the forearm 2C above the heat pain threshold during needling and immediately after removal of the needles .
RESULTS	Experimentally-induced heat pain intensity ( VAS ) during and after the intervention was lower than pre-intervention but there were no statistically significant differences in this change between groups .
RESULTS	There were no statistically significant differences between groups in the time taken for pain intensity to decrease by 33 % from pre-intervention .
RESULTS	However , a 33 % decrease in pain intensity within 3min of needle insertion was observed for 13 participants ( 92.9 % ) in the four-needle group compared with 66.7 % of participants in the two-needle group and 57.1 % in the mock acupuncture group .
RESULTS	There was less variance in VAS in the four-needle group , suggesting more consistency in hypoalgesic response when using more needles .
CONCLUSIONS	There is tentative evidence that four needles may be superior to two needles in generating rapid onset hypoalgesia .
CONCLUSIONS	The findings suggest that further investigation is warranted .

###25182100
OBJECTIVE	Although conventional bariatric surgery results in weight loss , it does so with potential short-term and long-term morbidity .
OBJECTIVE	To evaluate the effectiveness and safety of intermittent , reversible vagal nerve blockade therapy for obesity treatment .
METHODS	A randomized , double-blind , sham-controlled clinical trial involving 239 participants who had a body mass index of 40 to 45 or 35 to 40 and 1 or more obesity-related condition was conducted at 10 sites in the United States and Australia between May and December 2011 .
METHODS	The 12-month blinded portion of the 5-year study was completed in January 2013 .
METHODS	One hundred sixty-two patients received an active vagal nerve block device and 77 received a sham device .
METHODS	All participants received weight management education .
METHODS	The coprimary efficacy objectives were to determine whether the vagal nerve block was superior in mean percentage excess weight loss to sham by a 10-point margin with at least 55 % of patients in the vagal block group achieving a 20 % loss and 45 % achieving a 25 % loss .
METHODS	The primary safety objective was to determine whether the rate of serious adverse events related to device , procedure , or therapy in the vagal block group was less than 15 % .
RESULTS	In the intent-to-treat analysis , the vagal nerve block group had a mean 24.4 % excess weight loss ( 9.2 % of their initial body weight loss ) vs 15.9 % excess weight loss ( 6.0 % initial body weight loss ) in the sham group .
RESULTS	The mean difference in the percentage of the excess weight loss between groups was 8.5 percentage points ( 95 % CI , 3.1-13 .9 ) , which did not meet the 10-point target ( P = .71 ) , although weight loss was statistically greater in the vagal nerve block group ( P = .002 for treatment difference in a post hoc analysis ) .
RESULTS	At 12 months , 52 % of patients in the vagal nerve block group achieved 20 % or more excess weight loss and 38 % achieved 25 % or more excess weight loss vs 32 % in the sham group who achieved 20 % or more loss and 23 % who achieved 25 % or more loss .
RESULTS	The device , procedure , or therapy-related serious adverse event rate in the vagal nerve block group was 3.7 % ( 95 % CI , 1.4 % -7.9 % ) , significantly lower than the 15 % goal .
RESULTS	The adverse events more frequent in the vagal nerve block group were heartburn or dyspepsia and abdominal pain attributed to therapy ; all were reported as mild or moderate in severity .
CONCLUSIONS	Among patients with morbid obesity , the use of vagal nerve block therapy compared with a sham control device did not meet either of the prespecified coprimary efficacy objectives , although weight loss in the vagal block group was statistically greater than in the sham device group .
CONCLUSIONS	The treatment was well tolerated , having met the primary safety objective .
BACKGROUND	clinicaltrials.gov Identifier : NCT01327976 .

###26101114
OBJECTIVE	The wahakura ( flax bassinet ) is presently being distributed as a safe infant sleeping device amongst New Zealand Mori , where sudden unexpected deaths in infancy ( SUDI ) rates are high .
OBJECTIVE	It is promoted as mitigating bedsharing risk by providing a separate infant sleeping surface .
OBJECTIVE	This study aimed to understand exactly what factors determine the apparent acceptability of the wahakura as an infant sleeping device to Mori mothers and other key Mori community stakeholders .
METHODS	The qualitative study used face-to-face , semi-structured interviews , following Mori cultural protocols , to explore the experiences and views of 12 Mori mothers and 10 key informants who had wahakura experience .
METHODS	We employed purposeful sampling of participants and thematic analysis of data .
RESULTS	The practical appeal of the wahakura related to its portability , the enabling of bedsharing and easier breastfeeding .
RESULTS	Considerable cultural and spiritual appeal was related to its native flax composition and traditional origin .
RESULTS	Health professionals found it useful to engage Mori women antenatally .
CONCLUSIONS	The study affirmed the acceptance of the wahakura as a culturally initiated endeavour , meaningfully engaging Mori mothers and families in SUDI risk mitigation .
CONCLUSIONS	It has the potential to capitalise on the benefits of bedsharing to enhance infant wellbeing while also safeguarding them from harm .

###25417042
OBJECTIVE	Breathlessness in patients with lung cancer is a common and distressing symptom affecting 50-70 % of patients , rising to some 90 % for those with advanced lung cancer .
OBJECTIVE	The aim of the current study was to assess how feasible inspiratory muscle training ( IMT ) is in the lung cancer population and explore changes in outcome variables .
METHODS	A pilot feasibility randomised trial was conducted in patients with clinically stable lung cancer .
METHODS	The experimental group received training using a pressure threshold device .
METHODS	Patients were instructed to carry out five IMT sessions weekly for 12 weeks for a total of 30 mins/day .
METHODS	Patients in the control group received standard care .
METHODS	Outcome measures were completed at baseline and monthly for 3 months , and included : physiological parameters ( FEV1 , FVC ) ; perceived severity of breathlessness using six 10-point NRS ; modified Borg Scale ; quality of life using the short form Chronic Respiratory Disease Questionnaire ; Hospital Anxiety and Depression Scale , and safety .
RESULTS	Forty-six patients ( M = 37 , F = 9 ) at a mean age of 69.5 years old and a mean of 16 months post-diagnosis who were not currently receiving chemotherapy and/or radiotherapy were recruited .
RESULTS	Seventy-percent had NSCLC and advanced disease .
RESULTS	Statistical ( area under the curve-AUC ) and clinically important differences were seen with regard to distress from breathlessness ( p = 0.03 ) , ability to cope with breathlessness ( p = 0.01 ) , satisfaction with breathlessness management ( p = 0.001 ) , fatigue ( p = 0.005 ) , emotional function ( p = 0.011 ) , breathlessness mastery ( p = 0.015 ) and depression ( p = 0.028 ) .
RESULTS	The m-Borg difference between the two groups at 3 months was 0.80 , which is borderline clinically significant .
RESULTS	Changes were more evident in the 3-month assessment where the effect of the intervention came to its peak .
CONCLUSIONS	This trial shows the IMT is feasible and potentially effective in patients with lung cancer .
CONCLUSIONS	These findings warrant a fully powered larger randomised controlled trial .

###25264782
BACKGROUND	Needle-free delivery improves the immunogenicity of DNA vaccines but is also associated with more local reactogenicity .
BACKGROUND	Here we report the first comparison of Biojector and needle administration of a candidate rAd5 HIV vaccine .
METHODS	Thirty-one adults , 18-55 years , 20 naive and 11 prior rAd5 vaccine recipients were randomized to receive single rAd5 vaccine via needle or Biojector IM injection at 1010 PU in a Phase I open label clinical trial .
METHODS	Solicited reactogenicity was collected for 5 days ; clinical safety and immunogenicity follow-up was continued for 24 weeks .
RESULTS	Overall , injections by either method were well tolerated .
RESULTS	There were no serious adverse events .
RESULTS	Frequency of any local reactogenicity was 16/16 ( 100 % ) for Biojector compared to 11/15 ( 73 % ) for needle injections .
RESULTS	There was no difference in HIV Env-specific antibody response between Biojector and needle delivery .
RESULTS	Env-specific antibody responses were more than 10-fold higher in subjects receiving a booster dose of rAd5 vaccine than after a single dose delivered by either method regardless of interval between prime and boost .
CONCLUSIONS	Biojector delivery did not improve antibody responses to the rAd5 vaccine compared to needle administration .
CONCLUSIONS	Homologous boosting with rAd5 gene-based vectors can boost insert-specific antibody responses despite pre-existing vector-specific immunity .
BACKGROUND	Clinicaltrials.gov NCT00709605 NCT00709605 .

###25591635
OBJECTIVE	To study different methods of treatment of patients with myofascial pain syndrome ( MFPS ) .
METHODS	We evaluated the efficacy of complex treatment in 152 patients with chronic tension-type headache ( ) and 96 patients with facial MFPS .
METHODS	The treatment included standard methods ( reflex therapy of and local injections of a combination of local anesthetics with small doses of steroids in trigger points in patients with facial MFPS .
METHODS	To assess the efficacy of tizanidine , patients were randomized into two comparable groups .
METHODS	The duration of the study was 12 weeks .
CONCLUSIONS	The combined therapy , including reflex action and tizanidine , speeds recovery from pain and ensures the stability of results .

###24925464
BACKGROUND	The long-term prognosis for localized pancreatic cancer ( PC ) remains poor .
BACKGROUND	Three randomized trials ( GEST phase III , JACCRO PC-01 phase II and GEMSAP phase II ) evaluated gemcitabine ( Gem ) with or without S-1 for patients with metastatic and locally advanced PC .
BACKGROUND	A pooled analysis based on published data examined whether Gem with S-1 ( GS ) is superior to Gem alone in overall survival ( OS ) in patients with locally advanced PC .
METHODS	Data were extracted on 193 patients : 31 ( JACCRO ) , 28 ( GEMSAP ) , and 134 ( GEST ) .
METHODS	OS was used for primary endpoint and progression-free survival ( PFS ) was used for secondary endpoint .
METHODS	A general variance-based method was used to estimate the pooled HR and 95 % CI between GS ( n = 96 ) and Gem ( n = 97 ) .
RESULTS	Meta-analysis demonstrated that the overall risk of death was significantly different between the two chemotherapies ( hazard ratio = 0.673 , 95 % confidence interval : 0.488-0 .929 , P = 0.016 ) .
RESULTS	The median PFSs for GS and GEM in the JACCRO , GEMSAP , and GEST studies were 12.0 , 12.6 , and 10.7 months , and 4.1 , 8.1 , and 6.2 months , respectively ( P = 0.001 ) .
RESULTS	The random-effect pooled estimate for 165 patients showed the objective response rate ( ORR ) in the GS group ( 28.4 % ) was better in the Gem group ( 8.3 % , P = 0.001 ) .
CONCLUSIONS	GS improved ORR , PFS and OS in patients with locally advanced PC over Gem alone .
CONCLUSIONS	GS could become one of the front-line chemotherapeutic agents .

###24360649
BACKGROUND	Both delay discounting and depression are risk factors for cigarette smoking during adolescence .
BACKGROUND	However , very little research has explored associations between these variables in adolescent smokers and non-smokers .
METHODS	Eighty adolescents were recruited based on depression status ( depressed and non-depressed ) and smoking status ( smokers and non-smokers ) to form four groups ( n = 20 per group ) .
METHODS	All participants completed a computerized monetary delay discounting task and a measure of depression .
RESULTS	Delay discounting and depression were significantly correlated .
RESULTS	Also , smokers ( both depressed and non-depressed ) and depressed non-smokers all discounted significantly more than non-smokers who were not depressed .
RESULTS	Depressed non-smokers and both groups of smokers did not differ in rate of delay discounting .
CONCLUSIONS	Adolescent non-smokers who are depressed discount similarly to adolescents who smoke and more than non-smokers who are not depressed .
CONCLUSIONS	Future research should explore the unique versus shared roles of delay discounting and depression as risk factors for smoking during adolescence .

###24646371
OBJECTIVE	To assess whether a 12-week participant-driven health education programme offered to individuals with screening-detected hyperglycaemia in Danish primary care would lead to improvements in cardiovascular risk factors , health behaviour and patient-reported outcomes after 3 years .
METHODS	We conducted a randomized controlled trial in 509 patients with screening-detected hyperglycaemia ( impaired fasting glucose , impaired glucose tolerance or type 2 diabetes ) from 33 general practices in Denmark .
METHODS	Individuals were pre-randomized to receive ( i ) routine care ( n = 187 ) , or ( ii ) an invitation to participate in the Ready to Act health education programme ( n = 322 ) .
METHODS	The programme was delivered over 12 weeks in primary care and focused on motivation , action experience , informed decision-making and social involvement to promote health behaviour change .
METHODS	The primary outcome was 10-year modelled cardiovascular risk .
RESULTS	Of 322 individuals , 123 ( 38 % ) received the intervention and 436/509 individuals ( 86 % ) returned for follow-up assessment .
RESULTS	There was no difference between the trial groups in modelled cardiovascular risk at 3 years ( relative difference : 1.01 ; 95 % CI : 0.84 to 1.23 ) .
RESULTS	Total cholesterol was lower ( -0.24 mmol/l , 95 % CI : -0.45 to -0.03 , P = 0.027 ) , and patient activation was higher in the intervention than in the control group ( 5.3 , 95 % CI : 0.97 to 9.7 ) .
RESULTS	No other between-group differences were observed for any cardiovascular risk factor , health behaviour or patient-reported outcome variables .
RESULTS	Subgroup analyses suggested that the intervention was more beneficial in those with impaired fasting glucose/impaired glucose tolerance than in those with type 2 diabetes .
CONCLUSIONS	For patients with screening-detected hyperglycaemia , a participant-driven health education programme was not associated with improvements in most clinical , behavioural and patient-reported outcomes after 3 years of follow-up .

###25125508
OBJECTIVE	Latinos with type 2 diabetes ( T2D ) face major healthcare access and disease management disparities .
OBJECTIVE	We examined the impact of the Diabetes Among Latinos Best Practices Trial ( DIALBEST ) , a community health worker ( CHW ) - led structured intervention for improving glycemic control among Latinos with T2D .
METHODS	A total of 211 adult Latinos with poorly controlled T2D were randomly assigned to a standard of healthcare ( n = 106 ) or CHW ( n = 105 ) group .
METHODS	The CHW intervention comprised 17 individual sessions delivered at home by CHWs over a 12-month period .
METHODS	Sessions addressed T2D complications , healthy lifestyles , nutrition , healthy food choices and diet for diabetes , blood glucose self-monitoring , and medication adherence .
METHODS	Demographic , socioeconomic , lifestyle , anthropometric , and biomarker ( HbA1c , fasting blood glucose , and lipid profile ) data were collected at baseline and 3 , 6 , 12 , and 18 months ( 6 months postintervention ) .
METHODS	Groups were equivalent at baseline .
RESULTS	Participants had high HbA1c at baseline ( mean 9.58 % [ 81.2 mmol/mol ] ) .
RESULTS	Relative to participants in the control group , CHWs had a positive impact on net HbA1c improvements at 3 months ( -0.42 % [ -4.62 mmol/mol ] ) , 6 months ( -0.47 % [ -5.10 mmol/mol ] ) , 12 months ( -0.57 % [ -6.18 mmol/mol ] ) , and 18 months ( -0.55 % [ -6.01 mmol/mol ] ) .
RESULTS	The overall repeated-measures group effect was statistically significant ( mean difference -0.51 % [ -5.57 mmol/mol ] , 95 % CI -0.83 , -0.19 % [ -9.11 , -2.03 mmol/mol ] , P = 0.002 ) .
RESULTS	CHWs had an overall significant effect on fasting glucose concentration that was more pronounced at the 12 - and 18-month visits .
RESULTS	There was no significant effect on blood lipid levels , hypertension , and weight .
CONCLUSIONS	DIALBEST is an effective intervention for improving blood glucose control among Latinos with T2D .

###26038078
BACKGROUND	The aims of this study were to evaluate with microcomputed tomography the orthodontically induced inflammatory root resorption in premolars caused by buccopalatal jiggling movement with light and heavy forces and to compare it with the resorption caused by equivalent but continuous buccal forces .
METHODS	The sample consisted of 60 maxillary first premolars collected from 30 patients ( 15 girls , 15 boys ; ages , 13-18years ) who required orthodontic treatment with extractions .
METHODS	They were divided into 3 groups of 10 patients .
METHODS	Light ( 25g ) or heavy ( 225g ) buccal tipping orthodontic forces were randomly assigned on the maxillary right or left quadrant with either continuous buccal ( positive controls ) or buccopalatal jiggling forces for 12weeks .
METHODS	At the end of the experimental period , the teeth were carefully extracted and processed for 3-dimensional imaging and volumetric evaluations of resorption craters .
METHODS	Data were analyzed with Wilcoxon signed rank tests .
RESULTS	There was no statistically significant difference between positive control light ( P = 0.0173 ) and heavy ( P = 0.0173 ) continuous forces and jiggling forces for both force magnitudes .
RESULTS	However , statistically significant differences were observed between heavy and light jiggling forces ( P = 0.038 ) , with heavy jiggling forces causing greater total root resorption than light jiggling forces .
CONCLUSIONS	Light and heavy jiggling forces in the buccopalatal direction did not cause significantly different amounts of root resorption when compared with continuous forces of the same magnitude .
CONCLUSIONS	On the other hand , light jiggling forces resulted in less root resorption than heavy jiggling forces .

###24852500
BACKGROUND	Low bispectral index values frequently reflect EEG suppression and have been associated with postoperative mortality .
BACKGROUND	This study investigated whether intraoperative EEG suppression was an independent predictor of 90 day postoperative mortality and explored risk factors for EEG suppression .
METHODS	This observational study included 2662 adults enrolled in the B-Unaware or BAG-RECALL trials .
METHODS	A cohort was defined with > 5 cumulative minutes of EEG suppression , and 1:2 propensity-matched to a non-suppressed cohort ( 5 min suppression ) .
METHODS	We evaluated the association between EEG suppression and mortality using multivariable logistic regression , and examined risk factors for EEG suppression using zero-inflated mixed effects analysis .
RESULTS	Ninety day postoperative mortality was 3.9 % overall , 6.3 % in the suppressed cohort , and 3.0 % in the non-suppressed cohort { odds ratio ( OR ) [ 95 % confidence interval ( CI ) ] = 2.19 ( 1.48-3 .26 ) } .
RESULTS	After matching and multivariable adjustment , EEG suppression was not associated with mortality [ OR ( 95 % CI ) = 0.83 ( 0.55-1 .25 ) ] ; however , the interaction between EEG suppression and mean arterial pressure ( MAP ) < 55 mm Hg was [ OR ( 95 % CI ) = 2.96 ( 1.34-6 .52 ) ] .
RESULTS	Risk factors for EEG suppression were older age , number of comorbidities , chronic obstructive pulmonary disease , and higher intraoperative doses of benzodiazepines , opioids , or volatile anaesthetics .
RESULTS	EEG suppression was less likely in patients with cancer , preoperative alcohol , opioid or benzodiazepine consumption , and intraoperative nitrous oxide exposure .
CONCLUSIONS	Although EEG suppression was associated with increasing anaesthetic administration and comorbidities , the hypothesis that intraoperative EEG suppression is a predictor of postoperative mortality was only supported if it was coincident with low MAP .
BACKGROUND	NCT00281489 and NCT00682825 .

###24930383
OBJECTIVE	Atherosclerosis is strongly associated with an increased mortality in subjects with diabetes .
OBJECTIVE	The carotid intima-media thickness ( IMT ) is commonly measured as a surrogate marker for cardiovascular risk .
OBJECTIVE	Statins are well-established protective agents against atherosclerosis and reportedly suppress IMT progression in subjects with diabetes .
OBJECTIVE	To clarify the effects of statins on subclinical atherosclerosis , we herein investigated changes in the carotid IMT and lipid profiles in a multi-center , prospective , randomized trial .
METHODS	Hypercholesterolemic subjects with type 2 diabetes were randomly assigned to open-label treatment with either pravastatin or pitavastatin .
METHODS	The primary endpoint of this study was the IMT change after 36 months of statin treatment .
RESULTS	A total of 97 subjects ( 51 pitavastatin ; 46 pravastatin ) completed this 36-month study .
RESULTS	The LDL-C decreased significantly from 163.4 27.9 mg/dl at baseline to 100.4 19.6 mg/dl at 36 months in the pitavastatin group and from 159.7 25.6 mg/dl to 118.5 22.1 mg/dl in the pravastatin group .
RESULTS	The mean IMT showed moderate regression in both the pitavastatin ( -0.070 0.215 mm , P < 0.05 ) and the pravastatin ( -0.067 0.260 mm ) group .
RESULTS	However , there was no significant difference in the IMT change between the two groups .
RESULTS	When the two groups were combined , the 36-month change in the mean IMT was significantly associated with HDL-C change ( r = -0.24 , P = 0.03 ) .
RESULTS	Multiple linear regression analysis revealed the change in HDL-C to be an independent variable showing a positive correlation with the carotid IMT reduction .
CONCLUSIONS	The administration of statins for 3 years to subjects with type 2 diabetes resulted in a significant regression of the carotid IMT .
CONCLUSIONS	An elevation of the plasma HDL-C with statin treatment was closely related to a regression of atherosclerosis .

###25923549
BACKGROUND	The EGFR T790M mutation is the most common mechanism of drug resistance to epidermal growth factor receptor ( EGFR ) tyrosine kinase inhibitors in patients who have lung cancer with an EGFR mutation ( EGFR-mutated lung cancer ) .
BACKGROUND	In preclinical models , the EGFR inhibitor AZD9291 has been shown to be effective against both EGFR tyrosine kinase inhibitor-sensitizing and T790M resistance mutations .
METHODS	We administered AZD9291 at doses of 20 to 240 mg once daily in patients with advanced lung cancer who had radiologically documented disease progression after previous treatment with EGFR tyrosine kinase inhibitors .
METHODS	The study included dose-escalation cohorts and dose-expansion cohorts .
METHODS	In the expansion cohorts , prestudy tumor biopsies were required for central determination of EGFR T790M status .
METHODS	Patients were assessed for safety , pharmacokinetics , and efficacy .
RESULTS	A total of 253 patients were treated .
RESULTS	Among 31 patients enrolled in the dose-escalation cohorts , no dose-limiting toxic effects occurred at the doses evaluated .
RESULTS	An additional 222 patients were treated in five expansion cohorts .
RESULTS	The most common all-cause adverse events were diarrhea , rash , nausea , and decreased appetite .
RESULTS	The overall objective tumor response rate was 51 % ( 95 % confidence interval [ CI ] , 45 to 58 ) .
RESULTS	Among 127 patients with centrally confirmed EGFR T790M who could be evaluated for response , the response rate was 61 % ( 95 % CI , 52 to 70 ) .
RESULTS	In contrast , among 61 patients without centrally detectable EGFR T790M who could be evaluated for response , the response rate was 21 % ( 95 % CI , 12 to 34 ) .
RESULTS	The median progression-free survival was 9.6 months ( 95 % CI , 8.3 to not reached ) in EGFR T790M-positive patients and 2.8 months ( 95 % CI , 2.1 to 4.3 ) in EGFR T790M-negative patients .
CONCLUSIONS	AZD9291 was highly active in patients with lung cancer with the EGFR T790M mutation who had had disease progression during prior therapy with EGFR tyrosine kinase inhibitors .
CONCLUSIONS	( Funded by AstraZeneca ; ClinicalTrials.gov number , NCT01802632 . )

###24918560
BACKGROUND	Brimonidine tartrate ( BT ) 0.5 % gel demonstrated significantly greater efficacy versus vehicle gel once-daily for the treatment of moderate to severe erythema of rosacea .
OBJECTIVE	To assess the 30-minute speed of onset of topical BT 0.5 % gel in reducing facial erythema in Phase III studies as measured by subject and clinician assessments of erythema .
METHODS	Two Phase III , randomized , controlled studies with identical design in which subjects with moderate erythema of rosacea ( study A : n = 260 ; study B : n = 293 ) were randomized 1:1 to apply topical BT 0.5 % or vehicle gel once-daily for 4 weeks .
METHODS	Evaluations included severity of erythema based on Clinician 's Erythema Assessment ( CEA ) and Patient 's Self-Assessment ( PSA ) prior to study drug application and at 30 minutes after application on days 1 , 15 , and 29 .
RESULTS	97.7 % and 96.6 % of subjects reported normal study completion for studies A and B , respectively .
RESULTS	The percentage of subjects achieving a 1-grade improvement in both CEA and PSA was significantly increased at 30 minutes post-dosing with BT 0.5 % gel compared to vehicle gel on visit days ( day 1 : 27.9 vs 6.9 % , P < 0.001 ; day 15 : 55.9 vs 21.1 % , P < 0.001 ; Day 29 : 58.3 vs 32.0 % , P < 0.001 for BT 0.5 % gel vs vehicle ) in study A. Similar results were shown for study B.
CONCLUSIONS	Once-daily topical BT gel 0.5 % is not only efficacious at reducing facial erythema but also exhibits response within 30 minutes of application in a significant number of patients throughout both Phase III studies .

###24433234
BACKGROUND	Family caregivers provide invaluable support to stroke survivors during their recovery , rehabilitation , and community re-integration .
BACKGROUND	Unfortunately , it is not standard clinical practice to prepare and support caregivers in this role and , as a result , many experience stress and poor health that can compromise stroke survivor recovery and threaten the sustainability of keeping the stroke survivor at home .
BACKGROUND	We developed the Timing it Right Stroke Family Support Program ( TIRSFSP ) to guide the timing of delivering specific types of education and support to meet caregivers ' evolving needs .
BACKGROUND	The objective of this multi-site randomized controlled trial is to determine if delivering the TIRSFSP across the stroke care continuum improves caregivers ' sense of being supported and emotional well-being .
METHODS	Our multi-site single-blinded randomized controlled trial will recruit 300 family caregivers of stroke survivors from urban and rural acute care hospitals .
METHODS	After completing a baseline assessment , participants will be randomly allocated to one of three groups : 1 ) TIRSFSP guided by a stroke support person ( health care professional with stroke care experience ) , delivered in-person during acute care and by telephone for approximately the first six to 12 months post-stroke , 2 ) caregiver self-directed TIRSFSP with an initial introduction to the program by a stroke support person , or 3 ) standard care receiving the educational resource `` Let 's Talk about Stroke '' prepared by the Heart and Stroke Foundation .
METHODS	Participants will complete three follow-up quantitative assessments 3 , 6 , and 12-months post-stroke .
METHODS	These include assessments of depression , social support , psychological well-being , stroke knowledge , mastery ( sense of control over life ) , caregiving assistance provided , caregiving impact on everyday life , and indicators of stroke severity and disability .
METHODS	Qualitative methods will also be used to obtain information about caregivers ' experiences with the education and support received and the impact on caregivers ' perception of being supported and emotional well-being .
CONCLUSIONS	This research will determine if the TIRSFSP benefits family caregivers by improving their perception of being supported and emotional well-being .
CONCLUSIONS	If proven effective , it could be recommended as a model of stroke family education and support that meets the Canadian Stroke Best Practice Guideline recommendation for providing timely education and support to families through transitions .
BACKGROUND	ClinicalTrials.gov : NCT00958607 .

###24953794
OBJECTIVE	To determine whether rituximab , a monoclonal antibody against the B-lymphocyte antigen CD20 , is effective in the treatment of refractory noninfectious scleritis .
METHODS	Prospective , dose-ranging , randomized , double-masked phase I/II clinical trial .
METHODS	Twelve patients with noninfectious scleritis refractory to systemic corticosteroid and 1 other systemic immunosuppressive agent were enrolled from January 2007 to March 2010 .
METHODS	Subjects were randomly assigned to 500 ( n = 5 ) or 1000 mg ( n = 7 ) dosing arms of rituximab intravenous infusions ( 500 or 1000 mg ) , given at study days 1 and 15 .
METHODS	Initial responders with breakthrough inflammation after study week 24 were offered treatment with an additional cycle of 2 open-label rituximab 1000 mg infusions .
METHODS	Primary outcomes were reduction of inflammation , as measured with a validated scleritis disease grading scale ( SGS ) and reduction in corticosteroid dose by 50 % .
METHODS	Patients were characterized as responders to study therapy if 1 of these endpoints showed improvement and neither showed evidence of worsening .
METHODS	Secondary outcomes were improvement in visual acuity , reduction in pain , and improvement in patient and physician-reported global health assessment .
RESULTS	Of 12 enrolled patients , 9 met the SGS endpoint at or before week 24 , and 4 additionally were able to reduce corticosteroid dose by 50 % .
RESULTS	With regard to secondary outcome measures , 11 and 9 patients showed improvement in patient and physician global health scores , respectively , and 7 patients had reduction in pain .
RESULTS	Of 9 initial responders , 7 experienced breakthrough inflammation after 24 weeks and were treated with a second cycle of rituximab infusions .
RESULTS	Four patients had significant objective or subjective worsening within 8 weeks of receiving rituximab ; this event was averted in subsequent patients by treatment with peri-infusional oral corticosteroid .
RESULTS	No other significant adverse events were noted .
RESULTS	No differences in efficacy , toxicity , or likelihood of retreatment were noted between the dosing arms .
CONCLUSIONS	Rituximab was effective treatment for 9 of 12 enrolled patients with refractory , noninfectious scleritis at 24 weeks , although 7 required reinfusion with rituximab to maintain inflammatory control .
CONCLUSIONS	The treatment was well-tolerated , and peri-infusional inflammatory exacerbations were managed successfully with oral corticosteroids .
CONCLUSIONS	Further long-term studies are warranted to determine the safety and efficacy of rituximab in treating noninfectious scleritis and other ocular inflammatory diseases .

###24468423
OBJECTIVE	Distress screening guidelines call for rapid screening for emotional distress at the time of cancer diagnosis .
OBJECTIVE	The purpose of this study was to examine the distress thermometer 's ( DT ) ability to screen in patients in treatment for advanced cancer who may be depressed .
METHODS	Using cross-sectional data collected from patients within 30 days of diagnosis with advanced cancer , this study used ROC analysis to determine the optimal-cutoff point of the distress thermometer ( DT ) for screening for depression as measured by the physician health questionnaire ( PHQ ) -9 ; inter-test reliability analysis to compare the DT with the PHQ-2 for screening in possible cases of depression , and multivariate analysis to examine associations among the DT emotional problem list ( EPL ) items with cases of depression .
RESULTS	The average age of the 123 patients in the study was 59.9 ( 12.9 ) years .
RESULTS	Seventy ( 56.9 % ) were female .
RESULTS	All had Stage 3 or 4 cancers ( 40 % gastrointestinal , 19 % gynecologic , 20 % head and neck , 21 % lung ) .
RESULTS	The mean DT score was 4 ( 2.7 ) / 10 ; and 56 ( 43 % ) were depressed as measured by the PHQ-9 5 .
RESULTS	The optimal DT cut-off score to screen in possible cases of depression was 2/10 , with a sensitivity of .96 , compared to a sensitivity of .32 of the PHQ-2 2 .
RESULTS	Correlation coefficients for the DT 2 and the PHQ-2 with the PHQ-9 5 were 0.4 and -0.2 , respectively .
RESULTS	EPL items associated with cases of depression were Depression ( OR = 0.15 , 0.02-0 .85 ) and Sadness ( OR = 0.21 , 0.06-0 .72 ) .
CONCLUSIONS	The optimal DT threshold for identifying possible cases of depression at the time of diagnosis is 2 ; this threshold is more sensitive than the PHQ-2 2 .
CONCLUSIONS	EPL items may be used with the DT score to triage patients for evaluation .

###25226360
BACKGROUND	Open-heart surgery with cardiopulmonary bypass ( CPB ) is associated with a generalized immune response and postoperative lung dysfunction .
BACKGROUND	Chemokines are involved in the pathogenesis of postoperative lung dysfunction .
BACKGROUND	We investigated whether continued mechanical ventilation during CPB has an impact on chemokine serum concentrations .
METHODS	A total of 30 patients undergoing coronary artery bypass graft operation were randomized to either continuous ventilated group ( n = 15 ) or nonventilated group ( n = 15 ) .
METHODS	Blood samples were drawn at the beginning and at the end of surgery and on the 5 consecutive days .
METHODS	Serum CCL2 , CCL4 , and CCL20 concentrations were measured and given as mean standard deviation .
RESULTS	Chemokine concentrations were elevated at the end of surgery in both groups .
RESULTS	CCL2 and CCL4 levels returned to baseline on postoperative day ( POD ) -1 in the ventilation group and stayed elevated in the nonventilation group .
RESULTS	CCL4 serum levels were significantly lower in ventilated-group patients on POD-1 ( 10.9 [ 39.0 ] vs. 153.2 [ 168.1 ] ; p = 0.005 ) , POD-2 ( 16.8 [ 36.8 ] vs. 147.9 [ 165.4 ] ; p = 0.019 ) , POD-3 ( 14.2 [ 24.0 ] vs. 97.9 [ 87.1 ] ; p = 0.005 ) , and POD-5 ( 6.5 [ 25.0 ] vs. 33.6 [ 38.4 ] ; p = 0.045 ) .
CONCLUSIONS	Continued mechanical ventilation during CPB results in reduced CCL4 concentrations on POD-1 to -5 .

###25258014
BACKGROUND	The Women 's Health Initiative ( WHI ) low-fat ( 20 % kcal ) dietary modification ( DM ) trial ( 1993-2005 ) demonstrated a nonsignificant reduction in breast cancer , a nominally significant reduction in ovarian cancer , and no effect on other cancers ( mean 8.3 years intervention ) .
BACKGROUND	Consent to nonintervention follow-up was 83 % ( n = 37,858 ) .
BACKGROUND	This analysis was designed to assess postintervention cancer risk in women randomized to the low-fat diet ( 40 % ) versus usual diet comparison ( 60 % ) .
METHODS	Randomized , controlled low-fat diet intervention for prevention of breast and colorectal cancers conducted in 48,835 postmenopausal U.S. women , ages 50 to 79 years at 40 U.S. sites .
METHODS	Outcomes included total invasive cancer , breast cancer , and colorectal cancer , and cancer-specific and overall mortality .
RESULTS	There were no intervention effects on invasive breast or colorectal cancer , other cancers , or cancer-specific or overall mortality during the postintervention period or the combined intervention and follow-up periods .
RESULTS	For invasive breast cancer , the hazard ratios ( HR ) and 95 % confidence interval ( CI ) were 0.92 ( 0.84-1 .01 ) during intervention , 1.08 ( 0.94-1 .24 ) during the postintervention period , and 0.97 ( 0.89-1 .05 ) during cumulative follow-up .
RESULTS	A reduced risk for estrogen receptor positive/progesterone receptor-negative tumors was demonstrated during follow-up .
RESULTS	In women with higher baseline fat intake ( quartile ) , point estimates of breast cancer risk were HR , 0.76 ( 95 % CI , 0.62-0 .92 ) during intervention versus HR , 1.11 ( 95 % CI , 0.84-1 .4 ) during postintervention follow-up ( Pdiff = 0.03 ) .
CONCLUSIONS	Dietary fat intake increased postintervention in intervention women ; no long-term reduction in cancer risk or mortality was shown in the WHI DM trial .
CONCLUSIONS	Dietary advisement to reduce fat for cancer prevention after menopause generally was not supported by the WHI DM trial .

###25198813
OBJECTIVE	Few randomized studies have investigated the impact of valved and non-valved power-injectable peripherally inserted central catheters ( PICCs ) in terms of incidence of occlusion , infection , malfunction and venous thrombosis .
METHODS	We have prospectively compared three types of third-generation polyurethane PICCs .
METHODS	One hundred and eighty adult patients candidate to chemotherapy were randomized into three groups : power-injectable PICCs with Solo-2 proximal valve ( Bard ) ; power-injectable PICCs with PASV ( Pressure Activated Safety Valve ) proximal valve ( Navilyst ) ; and non-valved power-injectable PICCs ( Medcomp ) .
METHODS	All PICCs were single lumen 4Fr , inserted according to a well-defined protocol - maximal barrier precautions , ultrasound guidance , intracavitary electrocardiography ( IC-ECG ) , and so on -- and managed according to the recommendations of the most recent guidelines ( antisepsis with 2 % chlorhexidine , transparent dressing , sutureless device , strict ` scrub the hub ' policy , neutral displacement needle-free connectors and so on ) .
METHODS	All catheters were flushed with 10 ml saline before and after each infusion , or with 20 ml saline after blood sampling or infusion of blood products .
METHODS	No heparin was used .
RESULTS	We detected no complications at insertion ; no PICC-related bloodstream infections ; no dislocations ; five cases of transient occlusion and two cases of persistent withdrawal occlusion , evenly distributed among the groups ; one episode of complete irreversible obstruction ( group A ) ; four episodes of asymptomatic peripheral venous thrombosis ; one episode of symptomatic , severe central vein thrombosis ( group B ) .
RESULTS	In 31 % of PICCs in group A ( 19/61 ) and in 65 % of group B ( 39/60 ) , difficulties with gravity infusion were reported ; three PICCs of group A were complicated by rupture of the intravascular tract during pump infusion .
RESULTS	Five PICCs were removed because of complications , four in group A ( one obstruction ; three ruptures ) and one in group B ( central venous thrombosis ) .
CONCLUSIONS	We found no clinical advantages of valved vs. non-valved PICCs .

###24325953
BACKGROUND	Breast reconstruction using the free muscle-sparing transversus abdominus myocutaneous or deep inferior epigastric perforator flaps are common methods for restoring mastectomy defects for breast cancer patients .
BACKGROUND	Despite its increasing popularity and safety , the abdominal donor site remains a major source of postoperative pain .
BACKGROUND	Conventional postoperative pain relief protocol consists primarily of a patient-controlled anesthesia device delivering intravenous opioids .
BACKGROUND	Opioids can cause numerous side effects such as sedation , headache , nausea , vomiting , breathing difficulties and bladder and bowel dysfunction .
BACKGROUND	A promising approach to provide postoperative pain control of the abdominal incision is the newly developed transversus abdominis plane peripheral nerve block .
METHODS	This study is a double-blind , placebo-controlled , randomized controlled trial designed to rigorously test the effectiveness of a transversus abdominis plane catheter delivering intermittent local anesthetic in reducing postoperative abdominal pain following abdominal tissue breast reconstruction .
METHODS	The primary objective of this study is compare the mean total opioid consumption in the first postoperative 48 hours between the control and study groups including the patient-controlled anesthesia amounts and oral narcotic doses converted to intravenous morphine equivalent units .
METHODS	The secondary outcome measures include the following parameters : total in-hospital cumulative opioid consumption ; daily patient-reported pain scores ; total in-hospital cumulative anti-nausea consumption ; nausea and sedation scores ; and Quality of Recovery score ; time to first bowel movement , ambulation , and duration of hospital stay .
CONCLUSIONS	Autologous breast reconstruction using abdominal tissue is rapidly becoming the reconstructive option of choice for postmastectomy patients across North America .
CONCLUSIONS	A substantial component of the pain experienced by patients after this abdominally based procedure is derived from the abdominal wall incision .
CONCLUSIONS	By potentially decreasing the need for systemic opioids and their associated side effects , this transversus abdominis plane block study will utilize the most scientifically rigorous double-blind , placebo-controlled , randomized controlled trial methodology to potentially improve both clinical care and health outcomes in breast cancer surgery patients .
BACKGROUND	Clinicaltrials.gov NCT01398982 .

###25039499
OBJECTIVE	Computed tomography perfusion provides information on tissue viability according to proposed thresholds .
OBJECTIVE	We evaluated thresholds for ischemic core and tissue at risk and subsequently tested their accuracy in independent datasets .
METHODS	Tissue at risk was evaluated in patients with persistent arterial occlusions , and ischemic core thresholds in patients with recanalization and major clinical improvement .
METHODS	Scans were randomly allocated to derivation or validation groups for tissue at risk and core analysis .
METHODS	Optimum thresholds using mean transit time ( MTT ) , cerebral blood flow ( CBF ) , cerebral blood volume , and delay time ( DT ) were assessed .
RESULTS	Absolute MTT , relative MTT and DT were best derived predictors of tissue at risk with thresholds of 7 seconds , 125 % , and 2 seconds respectively .
RESULTS	DT 2 seconds was the best predictor in the validation dataset ( 95 % agreement levels = -44 to +30 mL , Bias = -6.9 ) .
RESULTS	Absolute and relative MTT were the best derived predictors of infarct volume in the core group ( 8 seconds and 125 % respectively ) but relative CBF of 45 % performed best in the core validation dataset .
CONCLUSIONS	Time-based perfusion thresholds perform well as predictors of tissue at risk of infarction with DT the best predictor .
CONCLUSIONS	Relative CBF was the best predictor of ischemic core .
CONCLUSIONS	Evaluation in larger populations is needed to confirm the performance of tissue viability thresholds .

###25260025
BACKGROUND	The current study compares the effectiveness of a condensed 12-week version and a 24-week version of the same pediatric behavioral weight management program .
METHODS	Children ( n = 162 ) between the ages of 8 and 18 years ( baseline BMIz = 2.39 ; standard deviation = 0.29 ) were randomized to either a 12 - or 24-week version of the same behavioral weight management program .
METHODS	Child anthropometric data were recorded at baseline , 6 weeks , 12 weeks , 24 weeks , and 12 months .
METHODS	A two-level longitudinal model was used to examine within - and between-group differences in BMIz change over time .
RESULTS	A significant group-by-time interaction was found ( = -0.01 ; standard error , < 0.01 ; p < 0.01 ) with the 24-week group showing greater reductions in BMIz .
RESULTS	Children in the 24-week group showed significant BMIz reductions over time ( z = -5.18 ; p < 0.01 ) , but children in the 12-week group did not ( z = -0.85 ; p = 0.39 ) .
CONCLUSIONS	Children in the 24-week program demonstrated greater reductions in BMIz than children in the 12-week group .
CONCLUSIONS	Therefore , there may be additional benefit to sessions above and beyond the 8 - to 12-week minimum suggested for pediatric weight management programs .

###25330142
OBJECTIVE	The aim of this study is to compare preoperative and postoperative conditions of GMP-140 concentration , the aggregation and activation of platelets in congenital heart disease patients undergoing transcatheter closure of atrial septal defects ( ASDs ) or ventricular septal defects ( VSDs ) , and the appropriate dose of aspirin of patients after transcatheter closure .
METHODS	Thirty-two consecutive patients with ASD ( n = 16 ) and VSD ( n = 16 ) , as shown on transthoracic echocardiography and right heart catheter examination , were treated with a percutaneous catheter occlusion .
METHODS	The patients comprised 13 males and 19 females with a mean age of 25.69.15 .
METHODS	Patients were randomly assigned into two groups within half an hour after ASD or VSD occlusion .
METHODS	Group A cases were treated with 3mg/kg/day enteric-coated aspirin tablets for 6 months , while patients in group B received 5mg/kg/day enteric-coated aspirin tablets for 6 months .
RESULTS	The rates of platelet aggregation ( PAG ) in the immediate postoperative ASD/VSD occlusion were significantly higher than those in the preoperative ASD/VSD occlusion ( adenosine diphosphate [ ADP ] - induced PAG : 64.98 % 7.65 % vs. 86.33 % 6.54 % , p < 0.05 ; arachidonic acid [ AA ] - induced PAG : 62.92 % 9.11 % vs. 86.96 % 6.90 % , p < 0.05 , respectively ) .
RESULTS	After treatment with aspirin , the GMP-140 levels presented a clearly defined downward trend in the immediate postoperative period ( 3mg/kg/day aspirin : 18.303.42 vs. 13.371.80 , p < 0.05 ; 5mg/kg/day aspirin : 18.303.42 vs. 13.411.60 , p < 0.05 ) , but no obvious difference was observed considering the GMP-140 levels in the 4 days after occlusion ( all p > 0.05 ) .
CONCLUSIONS	Our study showed that the GMP-140 serum level and PAG were increased after ASD and VSD occlusion , and patients may have a trend of decreased GMP-140 serum levels after the ASD or VSD occlusion surgeries after the treatment with aspirin .
CONCLUSIONS	Daily oral administration of 3 and 5mg/kg/day aspirin can induce a significant decrease in PAG of patients after VSD/ASD occlusion .

###24874006
BACKGROUND	Up to 9 % of young people suffer from depression .
BACKGROUND	Unfortunately , many in need of help remain untreated .
BACKGROUND	The Internet offers anonymous ways to help depressed youth , especially those who are reluctant to search for help because of fear of stigma .
OBJECTIVE	Our goal was to evaluate the effectiveness of an individual chat treatment based on Solution-Focused Brief Therapy ( SFBT ) to young individuals aged 12-22 years with depressive symptoms by comparing it to a waiting list control group .
METHODS	For this study , 263 young people with depressive symptoms were randomized to the Web-based SFBT intervention , PratenOnline , or to a waiting list control condition .
METHODS	The chat treatment was delivered by trained professionals .
METHODS	Groups were compared on depressive complaints as measured by the Center for Epidemiologic Studies Depression Scale ( CES-D ) after 9 weeks and 4.5 months .
METHODS	For the chat group only , changes in depressive symptoms at 7.5 months after baseline were explored .
RESULTS	The experimental SFBT condition ( n = 131 ) showed significantly greater improvement than the waiting list condition ( n = 132 ) in depressive symptoms at 9 weeks and 4.5 months on the CES-D , with a small between group effect size at 9 weeks ( d = 0.18 , 95 % CI -0.10 to 0.47 ) and a large effect size at 4.5 months ( d = 0.79 , 95 % CI 0.45-1 .08 ) .
RESULTS	The percentage of participants showing a reliable and clinically significant change in depression was significantly larger for the SFBT intervention at 4.5 months only ( 28.2 % vs 11.4 % for the waiting list , P < .001 , number needed to treat = 6 ) .
RESULTS	At 7.5 months , the SFBT group showed further improvements .
RESULTS	However , results have to be considered carefully because of high attrition rates .
CONCLUSIONS	The Web-based SFBT chat intervention of PratenOnline was more effective than a waiting list control group in reducing depressive symptoms , and effects were larger at follow-up then at post-treatment .
CONCLUSIONS	More studies are needed to find out if outcomes will be replicated , especially for those younger than 18 year old .
BACKGROUND	Netherlands Trial Register : NTR 1696 ; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1696 ( Archived by WebCite at http://www.webcitation.org/6DspeYWrJ ) .

###24368558
OBJECTIVE	We investigated predictors for acute and persisting periprocedural ischemic brain lesions among patients with symptomatic carotid stenosis randomized to stenting or endarterectomy in the International Carotid Stenting Study .
METHODS	We assessed acute lesions on diffusion-weighted imaging 1 to 3 days after treatment in 124 stenting and 107 endarterectomy patients and lesions persisting on fluid-attenuated inversion recovery after 1 month in 86 and 75 patients , respectively .
RESULTS	Stenting patients had more acute ( relative risk , 8.8 ; 95 % confidence interval , 4.4-17 .5 ; P < 0.001 ) and persisting lesions ( relative risk , 4.2 ; 95 % confidence interval , 1.6-11 .1 ; P = 0.005 ) than endarterectomy patients .
RESULTS	Acute lesion count was associated with age ( by trend ) , male sex , and stroke as the qualifying event in stenting ; high systolic blood pressure in endarterectomy ; and white matter disease in both groups .
RESULTS	The rate of conversion from acute to persisting lesions was lower in the stenting group ( relative risk , 0.4 ; 95 % confidence interval , 0.2-0 .8 ; P = 0.007 ) , and was only predicted by acute lesion volume .
CONCLUSIONS	Stenting caused more acute and persisting ischemic brain lesions than endarterectomy .
CONCLUSIONS	However , the rate of conversion from acute to persisting lesions was lower in the stenting group , most likely attributable to lower acute lesion volumes .
CONCLUSIONS	Clinical Trial Registration - URL : www.isrctn.org .
CONCLUSIONS	Unique identifier : ISRCTN25337470 .

###25376189
OBJECTIVE	Compare efficacy of 0.5 % proparacaine eye drops and oral 25 % dextrose in reducing pain during screening for retinopathy of prematurity ( ROP ) .
METHODS	Double-blinded randomized controlled trial .
METHODS	Twenty eligible babies were randomized .
METHODS	Group I received 0.5 % proparacaine eye drops at first ROP screening , while Group II received 25 % dextrose orally .
METHODS	At second examination , babies received no intervention .
METHODS	Pain was assessed using Premature Infant Pain Profile ( PIPP ) score .
RESULTS	The mean ( SD ) PIPP during procedure in Group I were 15.5 2.06 and 14 2.4 at first and second screening ( p = 0.259 ) .
RESULTS	The mean ( SD ) PIPP in Group II were 14.2 1.8 and 14.9 2.5 at the first and second screening ( p = 0.428 ) .
RESULTS	Differences were not statistically significant .
RESULTS	The PIPP scores of Group I and Group II at the first screening were also not significantly different ( p = 0.165 ) .
CONCLUSIONS	ROP screening causes moderate to severe pain and neither proparacaine nor dextrose is an effective analgesic .

###26049689
BACKGROUND	High expression of human equilibrative nucleoside transporter 1 ( hENT1 ) is considered to predict survival in patients treated with adjuvant gemcitabine for pancreatic cancer .
BACKGROUND	A standard evaluation system for immunohistochemical analysis ( antibody , scoring system ) has not yet been established .
METHODS	CONKO-001 , a prospective randomised phase III study investigated the role of adjuvant gemcitabine ( gem ) as compared to observation ( obs ) .
METHODS	Tumour samples of 156 patients were analysed by immunohistochemistry with the rabbit monoclonal antibody SP120 ( Ventana Medical Systems ) for expression of hENT1 .
METHODS	Kaplan-Meier analyses for median disease-free survival ( DFS ) and overall survival ( OS ) were performed in dependence of hENT1 expression measured analogously to Farrell et al. 2009 and Poplin et al. 2013 .
RESULTS	For the 88 gem and 68 obs patients , median DFS/OS was 12.9 / 22.7 months and 6.2 / 19.1 months .
RESULTS	High hENT1 expression was not associated with improved median DFS ( Farrell : no hENT1 22.2 months , low hENT1 13.7 months , high hENT1 12.1 months , p = 0.248 ; Poplin : low hENT1 13.2 months versus high hENT1 11.5 months , p = 0.5 ) or median OS ( Farrell : no hENT1 21.7 months , low hENT1 24.7 months , high hENT1 19.5 , p = 0.571 ; Poplin : low hENT1 24.4 months versus high hENT1 19.7 months , p = 0.92 ;) in the gem group or in the obs group ( median DFS Farrell : no hENT1 5.1 months , low hENT1 6.2 months , high hENT1 7.5 months , p = 0.375 ; Poplin : low hENT1 6.2 months versus high hENT1 5.9 months , p = 0.83 ; median OS Farrell : no hENT1 20.2 months , low hENT1 17.7 months , high HENT1 19.1 months , p = 0.738 ; Poplin : low hENT1 17.7 months versus high hENT1 20.4 months , p = 0.65 ) measured by the Farrell or Poplin Score .
CONCLUSIONS	We can not confirm a predictive role of hENT1 measured by the clone SP120 rabbit antibody in our study population .
CONCLUSIONS	Reproducible standard procedures are urgently needed prior to the implementation or exclusion of hENT1 as a predictive biomarker in the treatment of pancreatic cancer .
BACKGROUND	ISRCTN34802808 .

###24766387
BACKGROUND	Hand eczema is a common disease , and continuous preventive skin protection and skin care must be adopted to prevent a chronic course .
BACKGROUND	Hand eczema is not a uniform disease , and counselling must therefore be individually tailored .
OBJECTIVE	To evaluate the effectiveness of a nurse-led counselling programme , the Healthy Skin Clinic , emphasizing the patient 's self-management , resources , and risks .
METHODS	Patients ( n = 306 ) referred for diagnostic work-up and treatment of hand eczema were randomized and allocated either to the programme or to usual care .
METHODS	The primary outcome was clinical disease severity at follow-up .
METHODS	Secondary outcomes were quality of life , burden of disease , skin protective behaviours , and self-reported medication adherence .
RESULTS	Patients in the intervention group had greater reductions in clinical severity and reported more beneficial behavioural changes at follow-up than those in the usual-care group .
RESULTS	This was especially true of patients who were treated solely with topical corticosteroids and who had a primarily exogenous aetiology of hand eczema .
RESULTS	However , the effect was very dependent on baseline disease severity .
RESULTS	No differences in quality of life or burden of disease were found between the two groups .
CONCLUSIONS	A tailored nurse-led programme of skin protection counselling may be recommended as an essential part of hand eczema treatment .

###25265986
BACKGROUND	Melasma is a commonly acquired hyperpigmentation symmetrically distributed on the face , neck , and arms .
BACKGROUND	The skin-lightening properties of Rumex occidentalis make it a therapeutic alternative to the reference standard treatment of hydroquinone ( HQ ) .
OBJECTIVE	This study was conducted to evaluate the safety and efficacy of 3 % R.occidentalis cream versus 4 % HQ cream in the management of epidermal and mixed melasma .
METHODS	This was a randomized , double-blind , placebo-controlled trial .
METHODS	Forty-five subjects with epidermal and mixed melasma were recruited to compare 3 % R.occidentalis cream , 4 % HQ cream , and placebo cream applied twice daily for eightweeks .
METHODS	Changes in pigmentation were measured every twoweeks using the Melasma Area Severity Index ( MASI ) and a mexameter .
METHODS	Adverse events were noted on every visit .
METHODS	Patient and investigator global evaluations were performed at the end of the study .
RESULTS	Overall mean MASI and mexameter readings in the three groups decreased from baseline to week 8 .
RESULTS	The greatest decline in score from weeks 2 to 6 was achieved by the HQ group , followed by the R.occidentalis group .
RESULTS	By week 8 , the R.occidentalis group showed a greater meanstandard deviation decline in MASI and mexameter readings from baseline ( MASI : 0.600.86 ; mexameter : 50.5625.63 ) than the HQ group ( MASI : 0.550.62 ; mexameter : 45.8947.83 ) .
RESULTS	The efficacy of R.occidentalis cream and HQ cream were assessed as similarly favorable by both study subjects and investigators .
CONCLUSIONS	Rumex occidentalis 3 % cream is a safe and effective skin-lightening agent for melasma and is comparable in efficacy with 4 % HQ cream .

###24259189
OBJECTIVE	Previous randomised trial data have demonstrated that male circumcision reduces Mycoplasma genitalium prevalence in men .
OBJECTIVE	We assessed whether male circumcision also reduces M genitalium infection in female partners of circumcised men .
METHODS	HIV-negative men were enrolled and randomised to either male circumcision or control .
METHODS	Female partners of male trial participants from the intervention ( n = 437 ) and control ( n = 394 ) arms provided interview information and self-collected vaginal swabs that were tested for M genitalium by APTIMA transcription-mediated amplification-based assay .
METHODS	Prevalence risk ratios ( PRR ) and 95 % CI of M genitalium prevalence in intervention versus control group were estimated using Poisson regression .
METHODS	Analysis was by intention-to-treat .
METHODS	An as-treated analysis was conducted to account for study-group crossovers .
RESULTS	Male and female partner enrolment sociodemographic characteristics , sexual behaviours , and symptoms of sexually transmitted infections were similar between study arms .
RESULTS	Female M genitalium prevalence at year 2 was 3.2 % ( 14/437 ) in the intervention arm and 3.6 % ( 14/394 ) in the control arm ( PRR = 0.90 , 95 % CI 0.43 to 1.89 , p = 0.78 ) .
RESULTS	In an as-treated analysis , the prevalence of M genitalium was 3.4 % in female partners of circumcised men and 3.3 % in female partners of uncircumcised men ( PRR = 1.01 , 95 % CI 0.48 to 2.12 , p = 0.97 ) .
CONCLUSIONS	Contrary to findings in men , male circumcision did not affect M genitalium infection in female partners .

###24647023
BACKGROUND	There is a paucity of evidence documenting the pathogenicity of Dientamoeba fragilis , an intestinal protozoan common in children .
BACKGROUND	As case reports on successful treatment are numerous , many authors advocate treatment , despite no placebo-controlled trials being available .
BACKGROUND	Metronidazole is often used for treatment , though eradication rates are relatively low ( 60 % -80 % ) .
BACKGROUND	In the present study we determined the clinical and microbiological efficacy of metronidazole in Danish children .
METHODS	In this parallel placebo-controlled double-blinded trial , children aged 3-12 years with > 4 weeks of gastrointestinal symptoms were allocated using block randomization in a 1:1 ratio to a 10-day course of oral metronidazole or placebo .
METHODS	Primary outcome was change in level of gastrointestinal symptoms , measured on a visual-analog-scale ( VAS ) , and secondary outcome was eradication of D. fragilis infection .
METHODS	Participants , caregivers , investigators , and sponsor were all blinded to group assignment .
METHODS	The trial was registered with clinicaltrials.gov ( NCT01314976 ) prior to start .
RESULTS	Of 96 participants , 48 were allocated to the metronidazole and placebo group each .
RESULTS	Mean VAS change from pre - to post-treatment did not differ significantly ( P = .8 ) between the metronidazole ( -1.8 CI , [ -2.5 , -1.1 ] ) and the placebo group ( -1.6 CI , [ -2.3 , -.9 ] ) .
RESULTS	Eradication of D. fragilis was significantly greater in the metronidazole group , although it declined rapidly from 62.5 % 2 weeks after end of treatment to 24.9 % 8 weeks after end of treatment .
CONCLUSIONS	These findings do not provide evidence to support routine metronidazole treatment of D. fragilis positive children with chronic gastrointestinal symptoms .
CONCLUSIONS	Study funded by Statens Serum Institut .
BACKGROUND	Trial was registered with clinicaltrials.gov ( NCT01314976 ) .

###24630348
OBJECTIVE	To examine the efficacy and safety of intramuscular botulinum toxin A ( BoNT-A ) to reduce spasticity and improve comfort and ease of care in nonambulant children with cerebral palsy ( CP ) .
METHODS	Nonambulant children with CP ( n = 41 ; Gross Motor Function Classification System level IV = 3 , level V = 38 ; mean age 7.1 years , range 2.3-16 years , 66 % male ) were randomly allocated to receive either intramuscular BoNT-A injections ( n = 23 ) or sham procedure ( n = 18 ) combined with therapy .
METHODS	The analysis used generalized estimating equations with primary outcome the Canadian Occupational Performance Measure ( COPM ) at 4 weeks postintervention and retention of effects at 16 weeks .
METHODS	Adverse events ( AE ) were collected at 2 , 4 , and 16 weeks by a physician masked to group allocation .
RESULTS	There were significant between group differences favoring the BoNT-A-treated group on COPM performance at 4 weeks ( estimated mean difference 2.2 , 95 % CI 0.8 , 3.5 ; P = .002 ) and for COPM satisfaction ( estimated mean difference 2.2 , 95 % CI 0.5 , 3.9 ; P = .01 ) .
RESULTS	These effects were retained at 16 weeks for COPM satisfaction ( estimated mean difference 1.8 , 95 % CI 0.1 , 3.5 ; P = .04 ) .
RESULTS	There were more mild AE at 4 weeks for the BoNT-A group ( P = .002 ) , however , there were no significant between-group differences in the reporting of moderate and serious AE .
CONCLUSIONS	In a double-blind randomized sham-controlled trial , intramuscular BoNT-A and therapy were effective for improving ease of care and comfort for nonambulant children with CP .
CONCLUSIONS	There was no increase in moderate and severe AE in the children who had BoNT-A injections compared with the sham group .

###25384463
OBJECTIVE	To examine whether adding either small , variable financial incentives or optional group sessions improves weight losses in a community-based , Internet behavioral program .
METHODS	Participants ( N = 268 ) from Shape Up Rhode Island 2012 , a 3-month Web-based community wellness initiative , were randomized to : Shape Up + Internet behavioral program ( SI ) , Shape Up + Internet program + incentives ( SII ) , or Shape Up + Internet program + group sessions ( SIG ) .
RESULTS	At the end of the 3-month program , SII achieved significantly greater weight losses than SI ( SII : 6.4 % [ 5.1-7 .7 ] ; SI : 4.2 % [ 3.0-5 .6 ] ; P = 0.03 ) ; weight losses in SIG were not significantly different from the other two conditions ( SIG : 5.8 % [ 4.5-7 .1 ] , P 's 0.10 ) .
RESULTS	However , at the 12-month no-treatment follow-up visit , both SII and SIG had greater weight losses than SI ( SII : 3.1 % [ 1.8-4 .4 ] ; SIG : 4.5 % [ 3.2-5 .8 ] ; SI : 1.2 % [ -0.1 -2.6 ] ; P 's 0.05 ) .
RESULTS	SII was the most cost-effective approach at both 3 ( SII : $ 34/kg ; SI : $ 34/kg ; SIG : $ 87/kg ) and 12 months ( SII : $ 64/kg ; SI : $ 140/kg ; SIG : $ 113/kg ) .
CONCLUSIONS	Modest financial incentives enhance weight losses during a community campaign , and both incentives and optional group meetings improved overall weight loss outcomes during the follow-up period .
CONCLUSIONS	However , the use of the financial incentives is the most cost-effective approach .

###24974440
BACKGROUND	Sensory and/or motor nerve function impairment as a consequence of neuropathy is often assessed using electroneurophysiological tests .
BACKGROUND	However , in low-resource countries where the required equipment is rarely available , manual muscle strength testing ( MMST ) and monofilament testing ( MFT ) offer very reliable alternatives .
BACKGROUND	In six leprosy programmes in four Asian countries , a multi-centre randomised clinical trial ( RCT ) was carried out to assess the effect of corticosteroids on neuropathy in leprosy-affected people .
BACKGROUND	The sensory and motor nerve function was tested using MMST and MFT , including new test sites for the sural and radial cutaneous nerves ( MFT ) and the posterior tibial and common peroneal nerves ( MMST ) .
BACKGROUND	The reliability studies of the MMST and MFT tests of the TENLEP ( Treatment of Early Neuropathy in LEProsy ) trials are presented here .
METHODS	Two assessors in each centre independently used the MFT and MMST in 30 leprosy-affected people .
RESULTS	Reliability is good to very good for MFT in nearly all nerves .
RESULTS	MMST also shows good to very good agreement , with a few exceptions .
CONCLUSIONS	Our study confirms that MMST and MFT can be performed reliably , and that the new tests also have acceptable reliability .

###24304412
OBJECTIVE	To compare the efficacy of slow-release oral morphine ( SROM ) and methadone as maintenance medication for opioid dependence in patients previously treated with methadone .
METHODS	Prospective , multiple-dose , open label , randomized , non-inferiority , cross-over study over two 11-week periods .
METHODS	Methadone treatment was switched to SROM with flexible dosing and vice versa according to period and sequence of treatment .
METHODS	Fourteen out-patient addiction treatment centres in Switzerland and Germany .
METHODS	Adults with opioid dependence in methadone maintenance programmes ( dose 50mg/day ) for 26 weeks .
METHODS	The efficacy end-point was the proportion of heroin-positive urine samples per patient and period of treatment .
METHODS	Each week , two urine samples were collected , randomly selected and analysed for 6-monoacetyl-morphine and 6-acetylcodeine .
METHODS	Non-inferiority was concluded if the two-sided 95 % confidence interval ( CI ) in the difference of proportions of positive urine samples was below the predefined boundary of 10 % .
RESULTS	One hundred and fifty-seven patients fulfilled criteria to form the per protocol population .
RESULTS	The proportion of heroin-positive urine samples under SROM treatment ( 0.20 ) was non-inferior to the proportion under methadone treatment ( 0.15 ) ( least-squares mean difference 0.05 ; 95 % CI = 0.02 , 0.08 ; P > 0.01 ) .
RESULTS	The 95 % CI fell within the 10 % non-inferiority margin , confirming the non-inferiority of SROM to methadone .
RESULTS	A dose-dependent effect was shown for SROM ( i.e. decreasing proportions of heroin-positive urine samples with increasing SROM doses ) .
RESULTS	Retention in treatment showed no significant differences between treatments ( period 1/period 2 : SROM : 88.7 % / 82.1 % , methadone : 91.1 % / 88.0 % ; period 1 : P = 0.50 , period 2 : P = 0.19 ) .
RESULTS	Overall , safety outcomes were similar between the two groups .
CONCLUSIONS	Slow-release oral morphine appears to be at least as effective as methadone in treating people with opioid use disorder .

###24305572
BACKGROUND	The interrelationship between the well-being of injecting drug users ( IDUs ) and their family environment has been widely documented .
BACKGROUND	However , few intervention programs have addressed the needs of both IDUs and their family members .
METHODS	This study describes a randomized intervention pilot targeting 83 IDUs and 83 of their family members from four communes in Ph Th province , Vietnam .
METHODS	The IDUs and family members in the intervention condition received multiple group sessions , with the intent to improve psychological well-being and family relationships .
METHODS	The intervention outcomes ( depressive symptoms and family relations ) were evaluated at baseline , 3-month and 6-month follow-up assessments .
RESULTS	Depressive symptoms and family relations reported by IDUs were found to be correlated to those reported by their family members .
RESULTS	Overall , significant intervention effects on depressive symptoms and family relations were observed for both IDUs and family members .
RESULTS	A similar improvement pattern in family relations emerged for both the IDU and family member samples , although the intervention effect of reducing depressive symptoms was more sustainable for family members at the 6-month assessment when compared to the IDU sample .
CONCLUSIONS	The intervention pilot addressed challenges faced by IDUs and their family members and revealed correlated outcomes for the two groups .
CONCLUSIONS	Findings suggest a vital need to include family members in future drug prevention and harm reduction intervention efforts .

###24330482
BACKGROUND	Postoperative cognitive dysfunction ( POCD ) is well established in adults but has been underinvestigated in children .
BACKGROUND	As day-case procedures are increasingly common , it is important to establish whether children suffer significant POCD .
BACKGROUND	Pediatric POCD has been associated with several intravenous and inhalation anesthetics , but isoflurane has not been studied .
BACKGROUND	As evidence indicates superior recovery after propofol , the study compared POCD after propofol or isoflurane anesthesia .
OBJECTIVE	To compare the effects of propofol versus isoflurane upon children 's POCD .
METHODS	Fifty-eight children aged 5-14 years were randomized to propofol ( total intravenous anesthesia ) or isoflurane for day-case dental procedures .
METHODS	Reaction time ( RT ) , verbal and visual memory , psychomotor coordination , and attention were assessed preoperatively , prior to discharge and at 24 h.
RESULTS	Reaction time and psychomotor control were impaired postoperatively in both groups but recovered at 24 h. Delayed verbal recall was significantly impaired only after propofol .
RESULTS	Both groups had significant impairment of visual memory postoperatively and at 24 h , and of recognition memory postoperatively only .
CONCLUSIONS	Propofol and isoflurane exert similar adverse effects on RT , psychomotor coordination , and visual memory .
CONCLUSIONS	Selective impairment of verbal recall by propofol is consistent with adult evidence of the drug 's effect on retrieval .
CONCLUSIONS	The enduring postoperative impairment of memory has implications for instructions to parents and caregivers for the safety and well-being of children in the 24 h after day-case anesthesia with propofol and isoflurane .

###24560331
OBJECTIVE	Little is known about the impact of an oncological treatment on muscle mass and strength in patients with lung cancer and the impact of a subsequent rehabilitation program .
OBJECTIVE	This study investigates the effect of radical treatment and post-treatment pulmonary rehabilitation on muscle mass and strength in patients with lung cancer and the relationship between muscle mass and strength .
METHODS	Lung cancer patients , candidate for radical treatment , were randomly ( 2:1 ) allocated after radical treatment to either standard follow up ( CON ) or a 12-week rehabilitation training program ( RT ) .
METHODS	Muscle mass was estimated by bioelectric impedance and CT-scan .
METHODS	Muscle strength was estimated by measuring quadriceps force ( QF ) with a hand held dynamometer .
METHODS	All variables were measured before ( M1 ) and after radical treatment ( M2 ) , and at the earliest 12 weeks after randomization ( M3 ) .
METHODS	Data are presented as means with standard deviation .
RESULTS	45 lung cancer patients ( age : 65 years ( 9 ) ) participated in the study .
RESULTS	At M2 , both muscle cross sectional area ( MCSA ) and QF were significantly decreased ( p < 0.05 ) .
RESULTS	28 patients were randomized .
RESULTS	13/18 RT and 9/10 CON patients ended the trial .
RESULTS	At M3 , RT-patients improved significantly their MCSA compared to CON-patients ( MCSA : 6 cm ( 2 ) ( 6 ) ( p = 0.003 ) vs. 1cm ( 2 ) ( 11 ) ( p = 0.8 ) ) .
CONCLUSIONS	Muscle mass and strength : ( 1 ) are decreased at presentation in a substantial part of lung cancer patients ; ( 2 ) are significantly negatively affected by radical treatment and ( 3 ) completely recover after a 12 week structured rehabilitation program , whereas a further decline was observed in CON-patients .

###25342209
BACKGROUND	Negative affective states such as anxiety , depression and stress are significant risk factors for cardiovascular disease , particularly in cardiac and post-cardiac rehabilitation populations.Yoga is a balanced practice of physical exercise , breathing control and meditation that can reduce psychosocial symptoms as well as improve cardiovascular and cognitive function .
BACKGROUND	It has the potential to positively affect multiple disease pathways and may prove to be a practical adjunct to cardiac rehabilitation in further reducing cardiac risk factors as well as improving self-efficacy and post-cardiac rehabilitation adherence to healthy lifestyle behaviours .
METHODS	This is a parallel arm , multi-centre , randomised controlled trial that will assess the outcomes of post - phase 2 cardiac rehabilitation patients assigned to a yoga intervention in comparison to a no-treatment wait-list control group .
METHODS	Participants randomised to the yoga group will engage in a 12 week yoga program comprising of two group based sessions and one self-administered home session each week .
METHODS	Group based sessions will be led by an experienced yoga instructor .
METHODS	This will involve teaching beginner students a hatha yoga sequence that incorporates asana ( poses and postures ) , pranayama ( breathing control ) and meditation .
METHODS	The primary outcomes of this study are negative affective states of anxiety , depression and stress assessed using the Depression Anxiety Stress Scale .
METHODS	Secondary outcomes include measures of quality of life , and cardiovascular and cognitive function .
METHODS	The cardiovascular outcomes will include blood pressure , heart rate , heart rate variability , pulse wave velocity , carotid intima media thickness measurements , lipid/glucose profiles and C-reactive protein assays .
METHODS	Assessments will be conducted prior to ( week 0 ) , mid-way through ( week 6 ) and following the intervention period ( week 12 ) as well as at a four week follow-up ( week 16 ) .
CONCLUSIONS	This study will determine the effect of yoga practice on negative affective states , cardiovascular and cognitive function in post-phase 2 cardiac rehabilitation patients .
CONCLUSIONS	The findings may provide evidence to incorporate yoga into standardised cardiac rehabilitation programs as a practical adjunct to improve the management of psychosocial symptoms associated with cardiovascular events in addition to improving patients ' cognitive and cardiovascular functions .
BACKGROUND	ACTRN12612000358842 .

###24796484
BACKGROUND	The US FDA and the EMA have approved seven agents for the treatment of renal cell carcinoma , primarily based on differences in progression-free survival ( PFS ) .
BACKGROUND	Because PFS is an arbitrary endpoint we hypothesized that an analysis would demonstrate the growth rate of tumors remained constant at the time of RECIST-defined disease progression .
METHODS	We previously estimated the growth ( g ) and regression ( d ) rates and the stability of g using data from the Phase III trial comparing sunitinib and interferon .
RESULTS	Sufficient data were available and rate constants statistically valid in 321 of 374 patients randomized to sunitinib .
RESULTS	Median d was 00052 days ( -1 ) ; in 53 patients no tumor growth was recorded .
RESULTS	Median g was 000082 days ( -1 ) and was stable for a median of 275 days on therapy , remaining stable beyond 300 , 600 and 900 days in 122 , 65 and 27 patients , respectively .
RESULTS	A possible increase in g while receiving sunitinib could be discerned in only 18 of 321 patients .
RESULTS	Given a median g of 000082 days ( -1 ) the estimated median time to a second progression were sunitinib continued past RECIST-defined progression was 7.3 months .
RESULTS	At 100 , 200 , and 300 days after starting therapy , an estimated 47 % , 27 % , and 13 % of tumor remains sunitinib sensitive and could explain a RECIST-defined response to a new TKI .
CONCLUSIONS	Prolonged stability of g with sunitinib suggests continued sunitinib beyond RECIST-defined progression may provide a beneficial outcome .
CONCLUSIONS	Randomized trials in patients whose disease has `` progressed '' on sunitinib are needed to test this hypothesis .

###24262059
BACKGROUND	The effectiveness of chest compressions for cardiopulmonary resuscitation ( CPR ) is affected by the rescuer 's position with respect to the patient .
BACKGROUND	In hospitals , chest compressions are typically performed while standing beside the patient , who is placed on a bed .
OBJECTIVE	To compare the effectiveness of chest compressions , performed on a bed during 2 min of CPR , among three different rescuer positions : standing , on a footstool , or kneeling on the bed .
METHODS	We performed a crossover randomized simulation trial .
METHODS	Participants were recruited from among students in the Department of Paramedics from July to August 2011 .
METHODS	Thirty-eight participants were enrolled , and they performed chest compressions on a mannequin for 2 min in each of the three different positions , with a 1-week interval between each position .
RESULTS	The number of adequate compressions ( depth > 50 mm ) and the mean compression depth were significantly greater in the kneeling and footstool positions than in the standing position , but there was no significant difference between the kneeling and footstool positions .
RESULTS	There were no significant differences in the compression rate , the percentage of correctly released compressions , and the percentage of compressions performed using the correct hand position among the three rescuer positions .
CONCLUSIONS	The mean compression depth and the number of adequate compressions were greater for both the kneeling and footstool positions than for the standing position during 2 min of CPR .
CONCLUSIONS	We recommend kneeling on a bed or standing on a footstool as the rescuer positions during hospital CPR on a bed .

###25809853
BACKGROUND	Plant sterols ( PSs ) lower LDL cholesterol , an established risk factor for coronary artery disease ( CAD ) .
BACKGROUND	No direct evidence is available supporting a reduced risk of CAD for foods with added PSs .
BACKGROUND	Endothelial dysfunction is seen as an early indicator of atherosclerotic damage .
OBJECTIVE	This study was primarily designed to investigate the effect of a low-fat spread with added PSs on brachial artery endothelial function as measured by flow-mediated dilation ( FMD ) .
OBJECTIVE	Second , effects on arterial stiffness , blood pressure , serum lipids , and plasma PS concentrations were investigated .
OBJECTIVE	We hypothesized that PSs would not worsen FMD but would rather modestly improve FMD .
METHODS	This study had a double-blind , randomized , placebo-controlled , parallel design .
METHODS	After a 4-wk run-in period , 240 hypercholesterolemic but otherwise healthy men and women consumed 20 g/d of low-fat spread without ( control ) or with added PSs ( 3 g/d ) during 12 wk .
METHODS	Pre - and postintervention , vascular function measurements and blood sampling were performed .
RESULTS	In total , 232 participants completed the study period .
RESULTS	For the primary endpoint FMD , 199 participants were included in the statistical analysis .
RESULTS	PS intake did not affect FMD ( +0.01 percentage points ; 95 % CI : -0.73 , 0.75 ) compared with control .
RESULTS	Measures of arterial stiffness ( pulse wave velocity and augmentation index ) and blood pressure were also not significantly changed compared with control .
RESULTS	After PS intervention , LDL cholesterol significantly decreased on average by 0.26 mmol/L ( 95 % CI : -0.40 , -0.12 ) or 6.7 % compared with control .
RESULTS	Plasma sitosterol and campesterol concentrations significantly increased in the PS group up to on average 11.5 mol/L and 13.9 mol/L ( expressed as geometric means ) , respectively .
CONCLUSIONS	The intake of a low-fat spread with added PSs neither improved nor worsened FMD or other vascular function markers in hypercholesterolemic men and women .
CONCLUSIONS	As expected , serum LDL cholesterol decreased , whereas plasma PSs increased after PS intake .
CONCLUSIONS	This study was registered at clinicaltrials.gov as NCT01803178 .

###25444083
OBJECTIVE	In two 6-month , double-blind , placebo-controlled studies , rotigotine transdermal system was well-tolerated and efficacious monotherapy in early-stage PD .
OBJECTIVE	This post hoc analysis of the long-term open-label extensions ( NCT00594165 ; NCT00599196 ) of these studies assessed incidence and severity of dyskinesia in participants treated with rotigotine , with or without concomitant levodopa , for up to 6 years .
METHODS	Open-label rotigotine was titrated to optimal dose ( 16mg/24h ) .
METHODS	Concomitant levodopa was permitted .
METHODS	Dyskinesia data , recorded using the Unified Parkinson 's Disease Rating Scale Part IV , were pooled from the two open-label studies .
RESULTS	Of 596 participants who received open-label rotigotine , 299 ( 50 % ) remained at trial closure ; no patient discontinued due to dyskinesia .
RESULTS	In the two studies , median exposure to rotigotine was 1910 days ( 5 years , 3 months ) , and 1564.5 days ( 4 years , 3 months ) .
RESULTS	During up to 6 years of open-label rotigotine , 423/596 ( 71 % ) received levodopa .
RESULTS	Dyskinesias were reported in 115/596 ( 19 % ) participants , 90/115 ( 78 % ) of who developed dyskinesia after levodopa was added ; 25 reported dyskinesia in the absence of levodopa ( includes patients who never received open-label levodopa , and those who reported dyskinesia before starting concomitant levodopa ) .
RESULTS	Dyskinesia severity data were available for 107 of the 115 participants .
RESULTS	In 56/107 ( 52 % ) participants , dyskinesia was considered ` not disabling ' for all occurrences ; the worst-case severity was ` mildly disabling ' for 33/107 ( 31 % ) , and ` moderately ' or ` severely disabling ' for 18/107 ( 17 % ; 3 % of total participants ) .
CONCLUSIONS	During treatment with rotigotine in patients with PD for up to 6 years the incidence of dyskinesia was low , and the dyskinesia was generally ` not disabling ' or ` mildly disabling ' .

###24596359
OBJECTIVE	The aim of the study was to investigate how tailored exercise is experienced by cancer survivors .
METHODS	Twenty-five breast cancer survivors who were recently treated with systemic adjuvant treatments attended tailored exercise classes as a part of a randomized controlled exercise intervention study ( Breast Cancer and Exercise , BREX ) .
METHODS	Focus group discussions with a median of four ( range 3-6 ) participants in each group were conducted to capture their individual experiences of their course of illness , taking part in the exercise trial , the personal meaning of tailored exercise classes and the group .
RESULTS	Attending the intervention in which the focus of attention was on physical rehabilitation was highly valued , since the participants experienced both improved physical fitness and improved coping .
RESULTS	Due to altered physical appearance and poor physical fitness , the participants felt that tailored exercise for patients with breast cancer reduced their barrier to start exercising .
RESULTS	Peer support from the group was valued , especially that of sharing experiences , receiving psychological support and gaining a sense of normality .
RESULTS	A sense of mastery over their disease through participating in the intervention , i.e. better psychological functioning and improved mood , was a consequence of better physical fitness and of meeting other breast cancer survivors .
RESULTS	Also participating in the study per se increases a sense of comfort and security with extra medical examinations and follow-up .
CONCLUSIONS	Participating in the tailored exercise group for breast cancer survivors helped patients gain a sense of mastery , restoring their self-esteem and constructing a meaning for their cancer experience and its impact on their lives .

###24314887
OBJECTIVE	We wanted to assess if sertraline treatment ( versus placebo ) or remission of depression at 12 weeks ( versus nonremission ) in Alzheimer patients is associated with improved caregiver well being .
METHODS	We conducted a randomized , double-blind , placebo-controlled clinical trial of the efficacy and safety of sertraline for the treatment of depression in individuals with Alzheimer disease in five clinical research sites across the United States .
METHODS	Participants were caregivers of patients enrolled in the Depression in Alzheimer 's Disease Study 2 ( N = 131 ) .
METHODS	All caregivers received standardized psychosocial support throughout the study .
METHODS	Caregiver outcome measures included depression ( Beck Depression Inventory ) , distress ( Neuropsychiatric Inventory ) , burden ( Zarit Burden Interview ) , and quality of life ( Medical Outcomes Study Short Form Health Survey ) .
RESULTS	Fifty-nine percent of caregivers were spouses , 63.4 % were women , and 64.1 % were white .
RESULTS	Caregivers of patients in both treatment groups had significant reductions in distress scores over the 24-week study period , but there was not a greater benefit for caregivers of patients taking sertraline .
RESULTS	However , caregivers of patients whose depression was in remission at week 12 had greater declines in distress scores over the 24 weeks than caregivers of patients whose depression did not remit by week12 .
CONCLUSIONS	Patient treatment with sertraline was not associated with significantly greater reductions in caregiver distress than placebo treatment .
CONCLUSIONS	Distress but not level of depression or burden lessened for all caregivers regardless of remission status and even more so for those who cared for patients whose depression remitted .
CONCLUSIONS	Results imply an interrelationship between caregiver distress and patient psychiatric outcomes .

###24660591
OBJECTIVE	Through experiment on animals and clinical trials to explore the safety and efficacy of hypoglycemic anti-deafness capsules on diabetic patients with deafness .
METHODS	Total 296 patients with non-insulin dependent diabetes mellitus ( NIDDM ) were randomly divided into two groups .
METHODS	A treatment group of 164 patients ( 208 ears ) was treated with hypoglycemic anti-deafness capsules based on TCM syndrome differentiation .
METHODS	A control group of 132 patients ( 184 ears ) was treated with glibenclamide and conventional drug treatment for deafness .
METHODS	The following were observed : hearing , fasting plasma glucose ( FPG ) , 2 h postprandial plasma glucose ( 2hPG ) , 24 h urine glucose ( 24hUG ) , improvement of main symptoms , platelet function , and changes in superoxide dismutase ( SOD ) and lipid peroxide ( LPO ) levels .
METHODS	In animal studies , Kunming mice , weighing 18-22 g were used .
METHODS	Half of the mice were males and half were females .
METHODS	Wistar rats , weighing 80-120 g were used .
METHODS	Half of the rats were males and half were females .
METHODS	Male Wistar rats , weighing 200-220 g , were also used .
METHODS	Their acute and chronic toxicity was studied .
RESULTS	The hearing improvement was 56.7 % in the treatment group and 26.6 % in the control group .
RESULTS	FPG , 2hPG , and 24hUG were improved significantly ( P < 0.05 , P < 0.01 , P < 0.01 , respectively ) in the treatment group and 2hPG and 24hUG improved significantly in the control group ( P < 0.05 , P < 0.05 ) .
RESULTS	The improvement in 2hPG and 24hUG in the treatment group was significantly greater than that in the control group P < 0.01 ) .
RESULTS	There was no significant difference in FPG between the two groups ( P < 0.05 ) .
RESULTS	Main symptoms in the treatment group were significantly more improved than those in the control group ( P < 0.05 , P < 0.01 ) .
RESULTS	In the treatment group , platelet adhesion and aggregation , SOD , and LPO were all significantly improved from before treatment ( P < 0.05 , P < 0.01 ) .
RESULTS	However , in the control group , except LOP ( P < 0.05 ) , there were no significant differences from before treatment to after ( P < 0.05 ) .
RESULTS	In animal studies , no obvious acute or long-term toxicity was observed from capsule administration .
CONCLUSIONS	Through experiment on animals and clinical trials , we can found that hypoglycemic anti-deafness capsules could decrease blood glucose and serum triglycerides of alloxan-induced diabetic rats .
CONCLUSIONS	This herbal capsule is effective for safely treating diabetic patients with deafness .

###24810181
OBJECTIVE	The primary objectives of this study were to evaluate the effect of food on the oral bioavailability and to evaluate the effect of diurnal variation on the pharmacokinetics of linifanib , a novel tyrosine kinase ( TK ) inhibitor selective for vascular endothelial growth factor ( VEGF ) and platelet-derived growth factor ( PDGF ) receptors , in patients with advanced solid tumors .
OBJECTIVE	Adverse events were monitored .
METHODS	This was a phase 1 , open-label , randomized , crossover study .
METHODS	Thirty-four patients received dosing regimens to evaluate linifanib pharmacokinetic parameters under fasting and non-fasting conditions and with morning or evening dosing .
METHODS	Adverse events ( AEs ) were assessed according to National Cancer Institute Common Terminology Criteria for AEs ( Version 3.0 ) .
RESULTS	The administration with food had a negligible effect on the AUC of linifanib , but the Cmax of linifanib was decreased by 40 % compared to the fasting condition .
RESULTS	Evening dosing after a 2-h fast had a negligible effect on AUC ; however , the dose-normalized Cmax of linifanib after evening dosing was 64 % of that after morning dosing following a 10-h fast .
RESULTS	Common Grade 3/4 AEs were fatigue ( 24 % ) , hypertension ( 21 % ) , and palmar-plantar erythrodysaesthesia syndrome ( 15 % ) .
CONCLUSIONS	Dosing with food or in the evening has a significant effect on the oral bioavailability of linifanib that should be taken into consideration when designing future clinical studies .
CONCLUSIONS	The pattern of adverse advents reported in this study is similar to that seen in other studies of linifanib and other agents in the VEGF/PDGF TK receptor inhibitor class .

###25733246
OBJECTIVE	To evaluate the efficacy and safety of sarilumab in combination with methotrexate ( MTX ) for the treatment of rheumatoid arthritis ( RA ) .
METHODS	Adults with moderate-to-severe RA and an inadequate response to MTX were randomized ( 1:1:1 ) to receive sarilumab ( doses of 150 mg or 200 mg ) or placebo every 2 weeks in conjunction with weekly MTX for 52 weeks .
METHODS	Co-primary end points were the proportion of patients achieving American College of Rheumatology 20 % ( ACR20 ) improvement responses at week 24 , change from baseline in the Health Assessment Questionnaire ( HAQ ) disability index ( DI ) at week 16 , and change from baseline in the modified Sharp/van der Heijde score ( SHS ) of radiographic damage at week 52 .
RESULTS	Baseline characteristics were similar among the groups .
RESULTS	For all 3 co-primary end points , the sarilumab 150 mg and 200 mg groups demonstrated statistically significant improvements as compared with the placebo group ( ACR20 response rate at week 24 , 58.0 % , 66.4 % , and 33.4 % , respectively [ P < 0.0001 ] ; least squares mean change in HAQ DI at week 16 , -0.53 , -0.55 , and -0.29 , respectively [ P < 0.0001 ] ; and mean change in SHS at week 52 , 0.90 , 0.25 , and 2.78 , respectively [ P < 0.0001 ] ) .
RESULTS	The most common treatment-emergent adverse event was infection .
RESULTS	In the sarilumab 150 mg , sarilumab 200 mg , and placebo groups , the incidence of serious infections was 2.6 % , 4.0 % , and 2.3 % , respectively .
RESULTS	Elevations in alanine aminotransferase levels > 3-fold the upper limit of normal occurred in 9.5 % , 8.0 % , and 2.1 % of patients , respectively ; in 24 patients , this led to discontinuation of treatment .
RESULTS	Elevated total cholesterol levels were observed in 36.8 % , 43.0 % , and 18.3 % of patients , respectively .
RESULTS	In patients receiving 150 mg and 200 mg sarilumab , neutrophil counts of 0.5 to < 1.0 10 ( 9 ) / liter were observed in 5.1 % and 7.8 % of patients , respectively , while neutrophil counts of < 0.5 10 ( 9 ) / liter were observed in 0.9 % and 0.7 % of patients , respectively ; none of the patients receiving placebo experienced changes in neutrophil counts .
CONCLUSIONS	In RA patients treated with sarilumab ( 150 mg or 200 mg every 2 weeks ) in combination with MTX , both doses provided sustained clinical efficacy , as shown by significant improvements in symptomatic , functional , and radiographic outcomes .
CONCLUSIONS	Sarilumab was generally well tolerated .
CONCLUSIONS	The adverse events observed in this study were consistent with the effects of interleukin-6 signaling blockade .

###24384878
OBJECTIVE	To evaluate long-term cure rates and late complication rates after treatment for female stress urinary incontinence ( SUI ) with transobturator tape ( TOT ) procedure and to compare the outcomes of 1st year versus 5th year .
METHODS	We analyzed 138 women who underwent TOT procedure for pure SUI and mixed urinary incontinence in two institutions during the time period of June 2005-May 2008 retrospectively .
METHODS	We used two kinds of polypropylene monofilament tapes ( Heine Medizinurethral support system , Germany and I-STOPCL Medical , France ) for the standard outside-in TOT in similar numbers .
METHODS	All patients were evaluated with pelvic examination including cough stress test and International Consultation on Incontinence Questionnaire-Short Form at 3 and 12 months and annually .
METHODS	Our primary outcome measures were rates of objective cure , subjective cure , patient satisfaction and failure for long-term follow-up .
RESULTS	The objective cure , subjective cure and patient satisfaction rates of the 126 women at 1 year were 89.6 , 86.5 and 92 % respectively .
RESULTS	During 5-year follow-up , objective cure rate was stable with 87.3 % rate ( p = 0.554 ) , whereas subjective cure and patient satisfaction rates were decreased to 65.9 and 73 % , respectively ( p = 0.001 ) .
RESULTS	Complications are reported according to the Clavien-Dindo classification with Gr I 14.3 % , Gr II 64.3 % , Gr IIIa 7.1 % and Gr IIIb 14.3 % .
CONCLUSIONS	TOT procedure is an effective minimal invasive procedure with satisfactory results for female SUI in short term .
CONCLUSIONS	Although recovery in SUI symptoms was stable during 5-year follow-up , subjective cure and patient satisfaction rates decreased significantly due to urge urinary incontinence symptoms .

###24431385
BACKGROUND	The infiltration of local anaesthetic ( LA ) , ketorolac , and epinephrine has been suggested to be effective for analgesia after total hip arthroplasty ( THA ) .
BACKGROUND	The part of action of each component of the mixture remains unclear .
BACKGROUND	We investigated the contribution of infiltration of ropivacaine alone on the morphine consumption during the first 24 h after surgery .
METHODS	Sixty patients undergoing primary THA were included in this prospective randomized double-blinded placebo-controlled trial , after IRB approval and informed consent .
METHODS	Surgical and general anaesthetic management were standardized .
METHODS	At the end of surgery , 80 ml of ropivacaine 0.2 % ( 160 mg ) or saline was infiltrated .
METHODS	The primary endpoint was morphine consumption 24 h after surgery .
METHODS	The secondary endpoints were : visual analogue scale scores and opioid side-effects at H2 , H4 , H8 , H12 , H24 , D1 , D2 , D3 , D4 , D5 , rehabilitation programme progress , chronic pain level , analgesic consumption , and surgical result at 3 months and 1 yr after surgery .
METHODS	The observation period was 1 yr .
RESULTS	Groups were similar for patient characteristic and perioperative characteristics .
RESULTS	The ropivacaine wound infiltration did not reduce morphine consumption at 24 h [ median ( 25th and 75th inter-quartile ) 27 ( 17-37 ) mg in the ropivacaine group vs 24 ( 18-34 ) mg in the placebo group , P = 0.51 ] or its side-effects .
RESULTS	No effect was found on rehabilitation progress or chronic pain after 3 months or 1 yr , but these were not the main endpoints of the study .
CONCLUSIONS	Ropivacaine infiltration alone did not reduce morphine consumption at 24 h after operation nor did it improve postoperative rehabilitation .

###24557349
OBJECTIVE	We assessed the associations of serum , red blood cell membranes ( RBCM ) and dietary long-chain n-3 polyunsaturated fatty acids ( LC-PUFAs ) with neovascular age-related macular degeneration ( AMD ) .
METHODS	We included 290 patients of the Nutritional AMD Treatment 2 Study ( NAT2 ) with neovascular AMD in one eye and early AMD lesions in the other eye , and 144 normal vision controls without AMD .
METHODS	Dietary intake of seafood was estimated by food frequency questionnaire .
METHODS	Eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) composition in serum and RBCM were determined by gas chromatography from 12-hour fasting blood samples and was expressed as percentages of total fatty acids profile .
METHODS	Logistic regressions estimated associations of neovascular AMD with dietary intake of seafood and circulating n-3 LC-PUFAs .
RESULTS	Dietary oily fish and seafood intake were significantly lower in AMD patients than in controls .
RESULTS	After adjustment for all potential confounders ( age , sex , CFH Y402H , ARMS2 A69S , and ApoE4 polymorphisms , plasma triglycerides , hypertension , hypercholesterolemia , and family history of AMD ) , serum EPA was associated significantly with a lower risk for neovascular AMD ( odds ratio [ OR ] = 0.41 ; 95 % confidence interval [ CI ] , 0.22-0 .77 ; P = 0.005 ) .
RESULTS	Analysis of RBCM revealed that EPA and EPA+DHA were associated significantly with a lower risk for neovascular AMD ( OR = 0.25 ; 95 % CI , 0.13-0 .47 ; P < 0.0001 and OR = 0.52 ; 95 % CI , 0.29-0 .94 ; P = 0.03 , respectively ) .
CONCLUSIONS	The RBCM EPA and EPA+DHA , as long-term biomarkers of n-3 dietary PUFA status , were associated strongly with neovascular AMD and may represent an objective marker identifying subjects at high risk for neovascular AMD , who may most benefit from nutritional interventions .
CONCLUSIONS	( http://www.controlled-trials.com/isrctn number , ISRCTN98246501 ) .

###24485548
BACKGROUND	Rates of varicella have decreased substantially in countries implementing routine varicella vaccination .
BACKGROUND	Immunisation is possible with monovalent varicella vaccine or a combined measles-mumps-rubella-varicella vaccine ( MMRV ) .
BACKGROUND	We assessed protection against varicella in naive children administered one dose of varicella vaccine or two doses of MMRV .
METHODS	This study was done in ten European countries with endemic varicella .
METHODS	Healthy children aged 12-22 months were randomised ( 3:3:1 ratio , by computer-generated randomisation list , with block size seven ) to receive 42 days apart ( 1 ) two doses of MMRV ( MMRV group ) , or ( 2 ) MMR at dose one and monovalent varicella vaccine at dose two ( MMR+V group ) , or ( 3 ) two doses of MMR ( MMR group ; control ) .
METHODS	Participants and their parents or guardians , individuals involved in assessment of any outcome , and sponsor staff involved in review or analysis of data were masked to treatment assignment .
METHODS	The primary efficacy endpoint was occurrence of confirmed varicella ( by detection of varicella zoster virus DNA or epidemiological link ) from 42 days after the second vaccine dose to the end of the first phase of the trial .
METHODS	Cases were graded for severity .
METHODS	Efficacy analyses were per protocol .
METHODS	Safety analyses included all participants who received at least one vaccine dose .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00226499 .
RESULTS	Between Sept 1 , 2005 , and May 10 , 2006 , 5803 children ( mean age 142 months , SD 25 ) were vaccinated .
RESULTS	In the efficacy cohort of 5285 children , the mean duration of follow-up in the MMRV group was 36 months ( SD 88 ) , in the MMR+V group was 36 months ( 85 ) and in the MMR group was 35 months ( 89 ) .
RESULTS	Varicella cases were confirmed for 37 participants in the MMRV group ( two moderate to severe ) , 243 in the MMR+V group , and 201 in the MMR group .
RESULTS	Second cases occurred for three participants ( all in the MMR+V group ) .
RESULTS	Varicella cases were moderate to severe for two participants in the MMRV group , 37 in the MMR+V group ( one being a second case that followed a mild first case ) ; and 117 in the MMR group .
RESULTS	Efficacy of two-dose MMRV against all varicella was 949 % ( 975 % CI 924-966 ) , and against moderate to severe varicella was 995 % ( 975-999 ) .
RESULTS	Efficacy of one-dose varicella vaccine against all varicella was 654 % ( 572-721 ) , and against moderate to severe varicella ( post hoc ) was 907 % ( 859-939 ) .
RESULTS	The most common adverse event in all groups was injection-site redness ( up to 25 % of participants ) .
RESULTS	Within 15 days after dose one , 574 % ( 95 % CI 539-609 ) of participants in the MMRV group reported fever of 38C or more , by contrast with 445 % ( 410-481 ) with MMR+V , and 398 % ( 338-461 ) with MMR .
RESULTS	Eight serious adverse events were deemed related to vaccination ( three MMRV , four MMR+V , one MMR ) .
RESULTS	All resolved within the study period .
CONCLUSIONS	These results support the implementation of two-dose varicella vaccination on a short course , to ensure optimum protection from all forms of varicella disease .
BACKGROUND	GlaxoSmithKline Vaccines .

###24929798
OBJECTIVE	For older adults with type 2 diabetes ( T2DM ) , declines in balance and walking ability are risk factors for falls , and peripheral neuropathy magnifies this risk .
OBJECTIVE	Exercise training may improve balance , gait and reduce the risk of falling .
OBJECTIVE	This study investigated the effects of 12weeks of aerobic exercise training on walking , balance , reaction time and falls risk metrics in older T2DM individuals with/without peripheral neuropathy .
METHODS	Adults with T2DM , 21 without ( DM ; age 58.71.7 years ) and 16 with neuropathy ( DM-PN ; age 58.91.9 years ) , engaged in either moderate or intense supervised exercise training thrice-weekly for 12weeks .
METHODS	Pre/post-training assessments included falls risk ( using the physiological profile assessment ) , standing balance , walking ability and hand/foot simple reaction time .
RESULTS	Pre-training , the DM-PN group had higher falls risk , slower ( hand ) reaction times ( 232 vs. 219ms ) , walked at a slower speed ( 108 vs. 113cm/s ) with shorter strides compared to the DM group .
RESULTS	Following training , improvements in hand/foot reaction times and faster walking speed were seen for both groups .
CONCLUSIONS	While falls risk was not significantly reduced , the observed changes in gait , reaction time and balance metrics suggest that aerobic exercise of varying intensities is beneficial for improving dynamic postural control in older T2DM adults with/without neuropathy .

###24304099
OBJECTIVE	The objective of this study was to compare acellular dermal matrix graft ( ADM ) combination with coronally advanced flap ( CAF ) on complete defect coverage , aesthetics and patient satisfaction with CAF alone for multiple recessions with gingival thickness ( GT ) < 0.8 mm .
METHODS	Forty-eight Miller Class I multiple recessions 3 mm were divided into test ( CAF + ADM ) and control ( CAF ) groups .
METHODS	At baseline and 12 months , recession height ( RH ) , keratinized tissue height ( KT ) , GT , mean and complete defect coverage were evaluated .
METHODS	Patient satisfaction , root coverage aesthetic score ( RES ) and the correlation between GT and defect coverage were also assessed .
RESULTS	Baseline RH in CAF + ADM and CAF groups was 3.25 0.34 mm and 3.21 0.26 mm , respectively .
RESULTS	Mean and complete defect coverage were 94.84 % and 83.33 % in test group , 74.99 % and 50.00 % in control group , respectively .
RESULTS	Inter-group differences were found to be statistically significant for RH reduction , attachment gain , KT and GT increase , mean defect coverage and RES in favour of test group ( p < 0.05 ) .
RESULTS	There was a significant positive correlation between GT and mean defect coverage ( p < 0.05 ) .
CONCLUSIONS	Coronally advanced flap in association with ADM can be proposed as a valid approach for the treatment of multiple recessions with thin tissue biotype .

###24724835
OBJECTIVE	The US Food and Drug Administration has said that oral preparations containing benzocaine should only be used in infants under strict medical supervision , due to the rare , but potentially fatal , risk of methemoglobinemia .
OBJECTIVE	This study aimed to determine the analgesic effect of topical application of benzocaine prior to lingual frenotomy in infants with symptomatic tongue-tie .
OBJECTIVE	We hypothesised that the duration of crying immediately following frenotomy with topical benzocaine would be shorter than with no benzocaine .
METHODS	This randomised controlled study compared the length of crying after lingual frenotomy in term infants who did , or did not , receive topical application of benzocaine to the lingual frenulum prior to the procedure .
RESULTS	We recruited 21 infants to this study .
RESULTS	Crying time was less than one minute in all of the subjects .
RESULTS	The average length of crying in the benzocaine group ( 21.6 13.6 sec ) was longer than the length of crying in the control group ( 13.1 4.0 sec ) , p = 0.103 .
CONCLUSIONS	Contrary to our hypothesis , infants who were treated with topical benzocaine did not benefit from topical analgesia in terms of crying time .
CONCLUSIONS	The use of benzocaine for analgesia prior to lingual frenotomy in term infants should therefore be discouraged .

###24444113
BACKGROUND	Computer-based decision support systems are a promising method for incorporating research evidence into clinical practice .
BACKGROUND	However , evidence is still scant on how such information technology solutions work in primary healthcare when support is provided across many health problems .
BACKGROUND	In Finland , we designed a trial where a set of evidence-based , patient-specific reminders was introduced into the local Electronic Patient Record ( EPR ) system .
BACKGROUND	The aim was to measure the effects of such reminders on patient care .
BACKGROUND	The hypothesis was that the total number of triggered reminders would decrease in the intervention group compared with the control group , indicating an improvement in patient care .
METHODS	From July 2009 to October 2010 all the patients of one health center were randomized to an intervention or a control group .
METHODS	The intervention consisted of patient-specific reminders concerning 59 different health conditions triggered when the healthcare professional ( HCP ) opened and used the EPR .
METHODS	In the intervention group , the triggered reminders were shown to the HCP ; in the control group , the triggered reminders were not shown .
METHODS	The primary outcome measure was the change in the number of reminders triggered over 12 months .
METHODS	We developed a unique data gathering method , the Repeated Study Virtual Health Check ( RSVHC ) , and used Generalized Estimation Equations ( GEE ) for analysing the incidence rate ratio , which is a measure of the relative difference in percentage change in the numbers of reminders triggered in the intervention group and the control group .
RESULTS	In total , 13,588 participants were randomized and included .
RESULTS	Contrary to our expectation , the total number of reminders triggered increased in both the intervention and the control groups .
RESULTS	The primary outcome measure did not show a significant difference between the groups .
RESULTS	However , with the inclusion of patients followed up over only six months , the total number of reminders increased significantly less in the intervention group than in the control group when the confounding factors ( age , gender , number of diagnoses and medications ) were controlled for .
CONCLUSIONS	Computerized , tailored reminders in primary care did not decrease during the 12 months of follow-up time after the introduction of a patient-specific decision support system .
BACKGROUND	ClinicalTrial.gov NCT00915304 .

###24856575
OBJECTIVE	To compare the safety , efficacy , and complications of percutaneous nephrolithotomy ( PCNL ) in the oblique supine lithotomy position vs the prone position in a randomized comparative study .
METHODS	The study included 101 and 102 patients in the oblique supine lithotomy position and prone position , respectively .
METHODS	Inclusion criteria were renal and upper ureteral stones .
METHODS	Exclusion criteria were uncorrectable bleeding disorders , active urinary tract infection , and pregnancy .
RESULTS	Both the groups were comparable regarding the male/female ratio , stone size , and site .
RESULTS	No significant differences were found in terms of the stone-free rate , blood transfusion rate , and complication rates .
RESULTS	Significant differences were reported in mean hemoglobin loss ( -1.03 and -2.18 g/dL ) , mean operative time ( 86.16 and 111.7 minutes ) , and mean hospital stay ( 49.88 and 81.2 hours ) in the supine and prone positions , respectively , and anesthesiological parameters ( the mean blood pressure decreased by 2 and 14.06 mm Hg , the mean heart rate changed by -0.82 and +13.28 beat/minute , and the peak air way pressure changed by +1.08 cm H2O and +7.56 cm H2O in the supine and prone positions , respectively ) .
CONCLUSIONS	PCNL in both positions was equally successful with no significant differences in complications .
CONCLUSIONS	PCNL in the oblique supine lithotomy position was superior to PCNL in the prone position regarding operative time , hospital stay , and effects on respiratory and cardiovascular status , making it more comfortable for patients and anesthesiologists .
CONCLUSIONS	Morbidly obese patients , patients with cardiologic disorders , and patients with pulmonary obstructive airway disease need further studies to show if they would benefit from these differences .
CONCLUSIONS	Additionally , it is more comfortable for the surgeon with little challenges added in the initial puncture .

###25100134
OBJECTIVE	Sunitinib is a first-line advanced renal cell carcinoma ( RCC ) standard of care .
OBJECTIVE	In a randomized phase II trial comparing sunitinib treatment schedules , separate exploratory biomarker analyses investigated the correlations of efficacy with selected serum , germ line single-nucleotide polymorphism ( SNP ) , or tumor markers .
METHODS	Advanced RCC patients received first-line sunitinib 50 mg/day on the approved 4-week-on-2-week-off schedule ( n = 146 ) or 37.5 mg/day continuous dosing ( n = 146 ) .
METHODS	The following correlation analyses were performed : ( 1 ) response evaluation criteria in solid tumors-defined tumor response with serum soluble protein levels via two distinct multiplex ( n < 1,000 ) platforms ; ( 2 ) response and time-to-event outcomes with germ line SNPs in vascular endothelial growth factor ( VEGF ) - A and VEGF receptor ( VEGFR ) 3 genes ; and ( 3 ) response and time-to-event outcomes with tumor immunohistochemistry status for hypoxia-inducible factor 1-alpha ( HIF-1 ) and carbonic anhydrase-IX or tumor Von Hippel-Lindau ( VHL ) gene inactivation status .
RESULTS	Lower baseline angiopoietin-2 ( Ang-2 ) and higher baseline matrix metalloproteinase-2 ( MMP-2 ) levels were identified by both platforms as statistically significantly associated with tumor response .
RESULTS	There were no significant correlations between VEGF-A or VEGFR3 SNPs and outcomes .
RESULTS	Progression-free survival was longer for HIF-1 percent of tumor expression groups 0-2 ( HIF-1 low ) versus 3-4 ( HIF-1 high ; p = 0.034 ) .
RESULTS	There were no significant correlations between outcomes and each VHL inactivation mechanism [ mutation ( 86 % of VHL-inactive patients ) , methylation ( 14 % ) , and large deletion ( 7 % ) ] or mechanisms combined .
CONCLUSIONS	Serum Ang-2 and MMP-2 and tumor HIF-1 were identified as relevant baseline biomarkers of sunitinib activity in advanced RCC , warranting further research into their prognostic versus predictive value .

###25175805
BACKGROUND	We previously reported a progressive decline in absolute responses of FEV1 and FVC to a near-maximal dose of 2 different short-acting bronchodilators over 4 years .
BACKGROUND	Since varying host factors and the method of expressing the response may impact the time trend of acute bronchodilator responses , we now examined the potential influence of salient host characteristics on changes in bronchodilator responses over time expressed in different ways .
METHODS	As part of the 4-year , placebo-controlled Understanding Potential Long-term Impacts on Function with Tiotropium ( UPLIFT ) trial , pre - and post-bronchodilator spirometry was performed at baseline and 1 month and every 6 months thereafter .
METHODS	Post-bronchodilator values for FEV1 and FVC were analyzed for subjects completing at least the 1 year visit ( Placebo - N = 2463 ; Tiotropium - N = 2579 ) , stratified by GOLD stage , age , gender and smoking status and expressed as absolute , relative ( % ) and % predicted changes from pre-bronchodilator values .
METHODS	Annual changes in bronchodilator response were estimated using linear mixed effects models .
RESULTS	For all subjects analyzed , FEV1 and FVC bronchodilator responses showed progressive and highly significant ( p < 0.0001 ) declines over 4 years .
RESULTS	Declines were generally larger in patients with severe/very severe than mild/moderate airflow obstruction , in older patients ( 65 yrs ) and in former than continuing smokers .
CONCLUSIONS	Acute FEV1 and FVC responses to bronchodilators decline significantly over time in COPD patients , whether expressed as absolute , relative or % predicted changes , potentially impacting on the clinical responses to bronchodilator therapy as well as on the annual rate of decline in post-bronchodilator lung function .
CONCLUSIONS	Clinicaltrials.gov number : NCT00144339 .

###25786048
OBJECTIVE	Fibromyalgia syndrome ( FMS ) is a chronic disorder characterised by widespread musculoskeletal pain , troubled sleep , disturbed mood , and fatigue .
OBJECTIVE	Recently published reviews have demonstrated that it is influenced by various psychological aspects , and antidepressants are now considered the treatment of choice for most patients .
OBJECTIVE	The aim of this randomised controlled trial was to compare the effects of duloxetine and acetyl L-carnitine on pain , depression , anxiety and well-being in FMS patients .
METHODS	Sixty-five female outpatients with FMS diagnosed by a rheumatologist were recruited between January 2011 and May 2012 , and randomised to receive duloxetine 60 mg/day or acetyl L-carnitine 1500 mg/day ( 500 mg t.i.d. ) .
METHODS	Drug efficacy and side effects were assessed by the same psychiatrist at baseline , and four and 12 weeks later .
RESULTS	Both drugs led to a general clinical improvement , with positive effects on pain and depressive symptoms ; but neither induced a significant improvement in anxiety .
RESULTS	Both drugs had a positive effect on the physical component of the quality of life , but only duloxetine improved the psychological component .
CONCLUSIONS	Although they need to be confirmed by further studies , these preliminary findings confirm the efficacy of duloxetine , and suggest that acetyl L-carnitine is also efficacious in improving depressive symptoms , pain , and the quality of life of FMS patients .

###25535142
OBJECTIVE	This work aims to explore the safety and efficacy of intracoronary tirofiban administration in patients with serious thrombus burden and ST-elevation myocardial infarction ( STEMI ) undergoing emergency percutaneous coronary intervention ( PCI ) .
METHODS	A total of 104 patients with serious thrombus burden and acute STEMI were randomly divided into treatment ( intracoronary tirofiban administration , 56 cases ) and control ( 48 cases ) groups .
METHODS	Comparison of coronary blood flow , ST-segment resolution ( STR ) , duration of hospital stay , 30-day major adverse cardiac events ( MACE ) and complications such as hemorrhage was conducted .
RESULTS	In treatment group , the percentage of thrombolysis in myocardial infarction-3 ( TIMI-3 ) flow in the infarct-related artery ( IRA ) increased ( 89.3 % to 85.4 , p < 0.05 ) , blood flow in the IRA calculated with TIMI frame count method enhanced [ ( 1.68 0.23 ) ml/s to ( 1.42 0.31 ) ml/s , p < 0.05 ] , STR on electrocardiogram ( ECG ) enlarged [ ( 64.3 7.84 ) % to ( 48.6 6.47 ) % , p < 0.05 ) ] and the prevalence of MACE decreased ( 10.7 % to 18.8 % , p < 0.05 ) , all of which were significantly different from those of control group , but no statistical difference in complications was observed between two groups ( p > 0.05 ) .
CONCLUSIONS	It was simple , safe and effective to perform intracoronary tirofiban administration in patients with serious thrombus burden and STEMI when undergoing emergency PCI .

###25591636
OBJECTIVE	To evaluate efficacy and safety of injectable extended-release naltrexone ( XR-NTX , Vivitrol ) , an opioid receptor antagonist , in the treatment of opioid dependence , we carried out a 1-year open-label extension study .
METHODS	The study followed the initial 6-month randomized , double-blind , PBO-controlled investigation of XR-NTX , used in dose 380 mg , as a treatment for opioid dependence .
METHODS	The study was conducted at 13 clinical sites in Russia .
METHODS	The main measurements were monthly urine samples ( efficacy ) and adverse events ( safety ) .
CONCLUSIONS	The open-label extension included 114 patients ( 67 continued on XR-NTX and 47 switched from placebo ) .
CONCLUSIONS	Overall , 62.3 % ( 95 % CI : 52.7 % , 71.2 % ) of patients completed the extension .
CONCLUSIONS	Urine testing revealed that 50.9 % ( 41.5 % , 60.4 % ) were abstinent from opioids at all assessments during the 1-year open-label phase .
CONCLUSIONS	Adverse events were reported by 21.1 % of patients .
CONCLUSIONS	Elevations in liver function tests occurred in 16.7 % of patients .
CONCLUSIONS	No severe adverse events were reported .
CONCLUSIONS	The data obtained demonstrate the long-term safety and efficacy of XR-NTX in opioid dependent patients .

###25312546
BACKGROUND	Despite considerable research on substance-abuse placement matching , evidence is still inconclusive .
BACKGROUND	The aims of this exploratory trial are to evaluate ( a ) the effects of following matching guidelines on health-care costs and heavy drinking , and ( b ) factors affecting the implementation of matching guidelines in the treatment of alcohol-dependent patients .
METHODS	A total of 286 alcohol-dependent patients entering one of four participating detoxification units and having no arrangements for further treatment will be recruited .
METHODS	During the first week of treatment , all patients will be administered Measurements in the Addictions for Triage and Evaluation ( MATE ) , European Quality of Life-Five Dimensions health status questionnaire ( EQ-5D ) , and the Client Socio -- Demographic and Service Receipt Inventory-European Version ( CSSRI-EU ) .
METHODS	Patients who are randomly allocated to the intervention group will receive feedback regarding their assessment results , including clear recommendations for subsequent treatment .
METHODS	Patients of the control group will receive treatment as usual and , if requested , global feedback regarding their assessment results , but no recommendations for subsequent treatment .
METHODS	At discharge , treatment outcome and referral decisions will be recorded .
METHODS	Six months after discharge , patients will be administered MATE-Outcome , EQ-5D , and CSSRI-EU during a telephone interview .
CONCLUSIONS	This trial will provide evidence on the effects and costs of using placement-matching guidelines based on a standardized assessment with structured feedback in the treatment of alcohol-dependent patients .
CONCLUSIONS	A process evaluation will be conducted to facilitate better understanding of the relationship between the use of guidelines , outcomes , and potential mediating variables .
BACKGROUND	German Clinical Trials Register DRKS00005035 .
BACKGROUND	Registered 03 June 2013 .

###24799482
OBJECTIVE	Positron emission tomography ( PET ) after chemotherapy can guide consolidating radiotherapy in advanced-stage Hodgkin lymphoma ( HL ) .
OBJECTIVE	This analysis aims to improve outcome prediction by integrating additional criteria derived by computed tomography ( CT ) .
METHODS	The analysis set consisted of 739 patients with residues2 .5 cm after chemotherapy from a total of 2,126 patients treated in the HD15 trial ( HD15 for advanced stage Hodgkin 's disease : Quality assurance protocol for reduction of toxicity and the prognostic relevance of fluorodeoxyglucose-positron-emission tomography [ FDG-PET ] in the first-line treatment of advanced-stage Hodgkin 's disease ) performed by the German Hodgkin Study Group .
METHODS	A central panel performed image analysis and interpretation of CT scans before and after chemotherapy as well as PET scans after chemotherapy .
METHODS	Prognosis was evaluated by using progression-free survival ( PFS ) ; groups were compared with the log-rank test .
METHODS	Potential prognostic factors were investigated by using receiver operating characteristic analysis and logistic regression .
RESULTS	In all , 548 ( 74 % ) of 739 patients had PET-negative residues after chemotherapy ; these patients did not receive additional radiotherapy and showed a 4-year PFS of 91.5 % .
RESULTS	The 191 PET-positive patients ( 26 % ) receiving additional radiotherapy had a 4-year PFS of 86.1 % ( P = .022 ) .
RESULTS	CT alone did not allow further separation of patients in partial remission by risk of recurrence ( P = .9 ) .
RESULTS	In the subgroup of the 54 PET-positive patients with a relative reduction of less than 40 % , the risk of progression or relapse within the first year was 23.1 % compared with 5.3 % for patients with a larger reduction ( difference , 17.9 % ; 95 % CI , 5.8 % to 30 % ) .
CONCLUSIONS	Patients with HL who have PET-positive residual disease after chemotherapy and poor tumor shrinkage are at high risk of progression or relapse .

###24820465
BACKGROUND	There is a need to investigate the treatment ( artesunate and quinine ) of severe malaria , as this will influence the outcome of morbidity and the mortality of the disease .
METHODS	An open randomized trial conducted at Kassala , Sudan .
METHODS	Patients with severe P. falciparum malaria were randomly assigned to either intravenous artesunate at 2.4 mg/kg at 0 , 12 , and 24 hours , then daily , or intravenous quinine at a 20 mg/kg loading dose , then 10 mg/kg three times a day .
METHODS	Fever and parasite clearance and coma resolution time were compared between the two groups .
RESULTS	The two groups ( 47 in each group ) were well matched in the clinical and biochemical characteristics .
RESULTS	Hypotension , convulsions , severe anemia , hypoglycemia , cerebral malaria , and jaundice were the predominant manifestations of severe malaria .
RESULTS	The mean ( SD ) of the fever clearance ( 10.8 [ 5.5 ] vs. 14.0 [ 8.1 ] hours , p = 0.028 ) and the parasite clearance time ( 16.5 [ 6.4 ] vs. 21.7 [ 11.3 ] hours , p = 0.007 ) were significantly shorter in the artesunate-treated patients .
RESULTS	In comatose patients , there was no difference between the two groups in coma resolution time .
RESULTS	Following quinine infusion , ten patients developed tinnitus ( p < 0.001 ) , and four had hypoglycemia ( p = 0.033 ) .
RESULTS	Tinnitus and hypoglycemia were not detected in the artesunate group .
RESULTS	One patient in the artesunate group died .
CONCLUSIONS	Artesunate is more effective than quinine , in term of parasite and fever clearance time , in the treatment of P. falciparum malaria in eastern Sudan .
CONCLUSIONS	The study found no difference between artesunate and quinine in coma resolution time .

###25616647
OBJECTIVE	A randomised , open label phase III trial was conducted to evaluate efficacy of nimotuzumab , a monoclonal antibody against epidermal growth factor receptor ( EGF-R ) added to standard therapy for newly diagnosed glioblastoma .
METHODS	149 glioblastoma patients stratified as with or without residual tumour were randomly assigned to receive either intravenous nimotuzumab 400mg weekly added to standard radiochemotherapy followed by 400mg biweekly after twelve weeks or standard radiochemotherapy .
METHODS	Progression status after 52 weeks ( 12moPFS ) and progression-free survival ( PFS ) based on Macdonald criteria were co-primary and overall survival ( OS ) , toxicity and quality of life secondary end-points .
RESULTS	142 patients were evaluated for efficacy ( per protocol cohort ) .
RESULTS	12 moPFS was 25.6 % in the experimental arm and 20.3 % in the control group .
RESULTS	In residual tumour patients ( n = 81 ) median PFS was 5.6 versus 4.0 months , ( hazard ratio ( HR ) , 0.87 ; 95 % confidence interval ( CI ) , 0.55-1 .37 ) , for patients without residual tumour ( n = 61 ) it was 10.6 versus 9.9 months , ( HR , 1.01 ; 95 % CI , 0.57-1 .77 ) .
RESULTS	Median OS in patients with residual tumour was 19.5 versus 16.7 months , ( HR , 0.90 ; 95 % CI , 0.52-1 .57 ; P = 0.7061 ) , for patients without 23.3 versus 21.0 months ( HR , 0.77 ; 95 % CI , 0.41-1 .44 ; P = 0.4068 ) .
RESULTS	A small cohort of MGMT non-methylated patients with residual tumour showed PFS of 6.2 versus 4.0 months ( HR , 0.77 ; 95 % CI , 0.35-1 .67 ; P = 0.4997 ) and OS of 19.0 versus 13.8 months ( HR , 0.66 ; 95 % CI , 0.27-1 .64 ; P = 0.3648 ) .
RESULTS	EGF-R amplification did not correlate with clinical efficacy of nimotuzumab .
RESULTS	Nimotuzumab was well tolerated .
CONCLUSIONS	This study , albeit negative , contains hypothesis generating signals supporting evaluation of correlative , efficacy-predicting tumour parameters for nimotuzumab in the treatment of glioblastoma .

###25087311
OBJECTIVE	To determine if acute pain response in infants after administration of pentavalent diphtheria ( polio , tetanus , acellular pertussis and B Type Hemophilus influenzae : Pentavac ) and meningitis C vaccine ( NeisVacC ) vary according to the administration order .
METHODS	A multicenter , randomized control trial , double-blind was performed in three pediatric nursing consultations of three healthcare centers between December 2010 , and December 2011 .
METHODS	Two months healthy children in subjected to a routine immunization .
METHODS	Routine immunizations are given in a different order to children ; first NeisVac C and then Pentavac are given to the Group A and first Pentavac and then NeisVac C are given to the Group B. Was measured infant pain during the injection of the vaccine using a validates method , the Modified Behavioral Pain Scale ( MBPS ) .
METHODS	Parents measured pain with the VAS scale and evaluated the presence of tears before the beginning of vaccination .
RESULTS	Within the 184 infants , 92 received the A order , and 92 the B order .
RESULTS	There were no differences between groups in terms of sociodemographic characteristics .
RESULTS	The average ( AV ) pain scores per infant after receiving injections were significantly lower when Pentavac was administered in a second place in A Group .
RESULTS	MBPS 5.6 ( SD 1.5 ) versus NeisVac C 7.6 ( SD 1.3 ) ( p = 0.0001 ) , EVA 3.6 Parents ( SD ) versus 5.4 ( DE 1.9 ) ( p = 0.0001 ) .
RESULTS	In B Group , the average for Pentavac '' BPS pain was 7.6 ( SD 1.5 ) versus 7.9 ( DE 1.2 ) to NeisVac C Parents EVA 5.5 ( SD 1.8 ) versus 6.3 ( SD 1.6 ) ( p = 0.004 ) .
CONCLUSIONS	Pain was reduced when Pentavac vaccine was administered before NeisVac C in infants subjected to a routine vaccination .
CONCLUSIONS	It is recommended that the order of injections of the vaccine will be first Pentavac followed by NeisVac C.

###24458078
OBJECTIVE	Few randomized controlled trials have compared intravenous iron products head to head in CKD patients with iron deficiency anemia .
OBJECTIVE	This study compared the efficacy and safety of two intravenous iron products ( ferumoxytol [ Feraheme injection ] and iron sucrose [ Venofer ] ) in patients with CKD and iron deficiency anemia .
METHODS	In this phase II , randomized , open-label , active-controlled , multicenter clinical trial , patients were randomized 1:1 to either 1.02 g ferumoxytol ( 2 510-mg injections ) or 1.0 g iron sucrose administered as either a slow injection or infusion ( 10 doses for dialysis patients and 5 doses for nondialysis patients ) .
METHODS	Inclusion criteria included hemoglobin < 11.0 g/dl , transferrin saturation < 30 % , and eGFR < 60 ml/min per 1.73 m ( 2 ) or a diagnosis of underlying CKD ( e.g. , nephropathy or nephritis ) .
METHODS	The primary end point was change in hemoglobin from baseline to week 5 .
RESULTS	In total , 162 patients were randomized .
RESULTS	Demographics were balanced between the treatment groups .
RESULTS	Adverse event profiles of the two regimens were fairly similar : overall adverse events , 48 % ferumoxytol versus 65 % iron sucrose ; related adverse events , 10 % ferumoxytol versus 16 % iron sucrose ; and adverse events leading to study discontinuation , 1 % ferumoxytol versus 5 % iron sucrose .
RESULTS	Rates of serious adverse events and related serious adverse events were similar between the ferumoxytol and iron sucrose groups : serious adverse events , 9 % versus 7 % , respectively and related serious adverse events , 1 % versus 1 % , respectively .
RESULTS	Overall , increases in hemoglobin were similar between treatment groups .
RESULTS	Based on an ANOVA model adjusted for baseline hemoglobin level and dialysis status , the least squares mean change from baseline to week 5 was 0.8 0.1 g/dl in the ferumoxytol-treated group and 0.7 0.1 g/dl in the iron sucrose group .
RESULTS	The difference in the mean change from baseline between the two treatment groups was 0.1 g/dl ( 95 % confidence interval , -0.2 to 0.4 ) .
CONCLUSIONS	In this randomized , controlled trial , ferumoxytol and iron sucrose showed comparable efficacy and adverse events rates .

###24726785
OBJECTIVE	To determine whether a transtheoretical model-based exercise stage-matched intervention ( ESMI ) has positive effects on the exercise behavior of sedentary patients with coronary heart disease ( CHD ) .
METHODS	The study was a randomized controlled trial with a repeated measures design .
METHODS	Participants ( N = 196 ) were randomly allocated to either a conventional ( C ) group , a patient education ( PE ) group , or an ESMI group .
METHODS	Exercise behavior was measured by exercise stages of change , exercise self-efficacy , exercise decisional balance , and duration of moderate exercise at baseline , immediate post-intervention , and at 3 - and 6-month follow-up .
RESULTS	Our results showed that the ESMI group demonstrated a more positive shift in exercise stages of change ( p < 0.01 ) , higher exercise self-efficacy ( p < 0.01 ) , greater exercise benefits ( p < 0.01 ) , fewer exercise barriers ( p < 0.01 ) , and longer moderate exercise duration ( minutes/week ) ( p < 0.01 ) after completion of the 8-week intervention compared with the C and PE groups .
RESULTS	These significantly positive effects were maintained at 3 - and 6-month follow-up .
CONCLUSIONS	The transtheoretical model-based ESMI had significantly positive effects on the exercise behavior of sedentary CHD patients .
CONCLUSIONS	It is important to provide a structured education program for CHD patients , preferably guided by the transtheoretical model .

###24562449
BACKGROUND	Previous investigations in pancreatic cancer suggested a prognostic role for secreted protein acidic and rich in cysteine ( SPARC ) expression in the peritumoral stroma but not for cytoplasmic SPARC expression .
BACKGROUND	The aim of this study was to evaluate the impact of SPARC expression in pancreatic cancer patients treated with gemcitabine compared with untreated patients .
METHODS	CONKO-001 was a prospective randomized phase III study investigating the role of adjuvant gemcitabine when compared with observation .
METHODS	Tissue samples of 160 patients were available for SPARC immunohistochemistry on tissue microarrays to evaluate its impact on patient outcome .
RESULTS	Strong stromal SPARC expression was associated with worse disease-free survival ( DFS ) and overall survival ( OS ) in the overall study population ( DFS : P = 0.005 , OS : P = 0.033 ) .
RESULTS	Its negative prognostic impact was restricted to patients treated with gemcitabine ( DFS : P = 0.007 , OS : P = 0.006 ) .
RESULTS	High cytoplasmic SPARC expression also was associated with worse patient outcome ( DFS : P = 0.041 , OS : P = 0.011 ) .
RESULTS	Again the effect was restricted to patients treated with gemcitabine ( DFS : P = 0.002 , OS : P = 0.003 ) .
RESULTS	In multivariable analysis , SPARC expression was independently predictive of patient outcome .
CONCLUSIONS	Our data confirm the prognostic significance of SPARC expression after curatively intended resection .
CONCLUSIONS	The negative prognostic impact was restricted to patients who received adjuvant treatment with gemcitabine , suggesting SPARC as a predictive marker for response to gemcitabine .

###24559218
BACKGROUND	The study was conducted to determine the clinical and cost effectiveness of enhanced multi-disciplinary teams ( EMDTs ) vs. ` usual care ' for the treatment of pressure ulcers in long term care ( LTC ) facilities in Ontario , Canada
METHODS	We conducted a multi-method study : a pragmatic cluster randomized stepped-wedge trial , ethnographic observation and in-depth interviews , and an economic evaluation .
METHODS	Long term care facilities ( clusters ) were randomly allocated to start dates of the intervention .
METHODS	An advance practice nurse ( APN ) with expertise in skin and wound care visited intervention facilities to educate staff on pressure ulcer prevention and treatment , supported by an off-site hospital based expert multi-disciplinary wound care team via email , telephone , or video link as needed .
METHODS	The primary outcome was rate of reduction in pressure ulcer surface area ( cm2/day ) measured on before and after standard photographs by an assessor blinded to facility allocation .
METHODS	Secondary outcomes were time to healing , probability of healing , pressure ulcer incidence , pressure ulcer prevalence , wound pain , hospitalization , emergency department visits , utility , and cost .
RESULTS	12 of 15 eligible LTC facilities were randomly selected to participate and randomized to start date of the intervention following the stepped wedge design .
RESULTS	137 residents with a total of 259 pressure ulcers ( stage 2 or greater ) were recruited over the 17 month study period .
RESULTS	No statistically significant differences were found between control and intervention periods on any of the primary or secondary outcomes .
RESULTS	The economic evaluation demonstrated a mean reduction in direct care costs of $ 650 per resident compared to ` usual care ' .
RESULTS	The qualitative study suggested that onsite support by APN wound specialists was welcomed , and is responsible for reduced costs through discontinuation of expensive non evidence based treatments .
RESULTS	Insufficient allocation of nursing home staff time to wound care may explain the lack of impact on healing .
CONCLUSIONS	Enhanced multi-disciplinary wound care teams were cost effective , with most benefit through cost reduction initiated by APNs , but did not improve the treatment of pressure ulcers in nursing homes .
CONCLUSIONS	Policy makers should consider the potential yield of strengthening evidence based primary care within LTC facilities , through outreach by APNs .
BACKGROUND	ClinicalTrials.gov identifier NCT01232764 .

###25246162
BACKGROUND	Pharmacokinetic parameters of sedative-hypnotic medications can be influenced by age and gender .
OBJECTIVE	This study analyzed pharmacokinetic parameters of zolpidem , formulated as a sublingual zolpidem tartrate tablet ( ZST ; Intermezzo ) , in healthy elderly males and females ( mean age 72 years ) and in non-elderly males and females ( 34 years ) .
METHODS	This was a randomized , single-dose , open-label , two-way crossover study evaluating pharmacokinetic parameters of 1.75 and 3.5 mg dosages of ZST in elderly subjects ( n = 22 ) , and 3.5 mg dosages of ZST in non-elderly subjects ( n = 24 ) .
METHODS	Main outcome measures were pharmacokinetic parameters , including area under the plasma concentration-time curve ( AUC ) , maximum observed concentration ( C ( max ) ) , time to reach C ( max ) ( T ( max ) ) , elimination half-life ( T ( ) ) , and apparent oral clearance ( CL/F ) .
RESULTS	Dose proportionality in zolpidem exposure was maintained between 1.75 and 3.5 mg doses for both elderly females and males .
RESULTS	With administration of the 3.5 mg dose of ZST to elderly and non-elderly subjects , significantly higher systemic exposure was seen in elderly females ( C ( max ) +44.6 % , P < 0.01 ; AUC +40.4 % ) compared with non-elderly females .
RESULTS	However , systemic exposure was only modestly higher in elderly males compared with non-elderly males .
RESULTS	Greater exposure was seen in elderly females compared to males ( C ( max ) +46.8 % , P < 0.01 ; AUC +31.4 % ) .
RESULTS	In this study , exposure between non-elderly females and males was equivalent .
RESULTS	Changes in T ( ) and T ( max ) values were not observed , with no significant age effect on oral clearance .
RESULTS	There were no apparent differences in tolerability among age and gender groups .
CONCLUSIONS	Elderly individuals were found to have higher C ( max ) and AUC values compared with non-elderly subjects .
CONCLUSIONS	C ( max ) and AUC were greater in elderly women compared with elderly men .

###25354103
BACKGROUND	Umbilical-cord blood has been used as the source of hematopoietic stem cells in an estimated 30,000 transplants .
BACKGROUND	The limited number of hematopoietic cells in a single cord-blood unit prevents its use in recipients with larger body mass and results in delayed hematopoietic recovery and higher mortality .
BACKGROUND	Therefore , we hypothesized that the greater numbers of hematopoietic cells in two units of cord blood would be associated with improved outcomes after transplantation .
METHODS	Between December 1 , 2006 , and February 24 , 2012 , a total of 224 patients 1 to 21 years of age with hematologic cancer were randomly assigned to undergo double-unit ( 111 patients ) or single-unit ( 113 patients ) cord-blood transplantation after a uniform myeloablative conditioning regimen and immunoprophylaxis for graft-versus-host disease ( GVHD ) .
METHODS	The primary end point was 1-year overall survival .
RESULTS	Treatment groups were matched for age , sex , self-reported race ( white vs. nonwhite ) , performance status , degree of donor-recipient HLA matching , and disease type and status at transplantation .
RESULTS	The 1-year overall survival rate was 65 % ( 95 % confidence interval [ CI ] , 56 to 74 ) and 73 % ( 95 % CI , 63 to 80 ) among recipients of double and single cord-blood units , respectively ( P = 0.17 ) .
RESULTS	Similar outcomes in the two groups were also observed with respect to the rates of disease-free survival , neutrophil recovery , transplantation-related death , relapse , infections , immunologic reconstitution , and grade II-IV acute GVHD .
RESULTS	However , improved platelet recovery and lower incidences of grade III and IV acute and extensive chronic GVHD were observed among recipients of a single cord-blood unit .
CONCLUSIONS	We found that among children and adolescents with hematologic cancer , survival rates were similar after single-unit and double-unit cord-blood transplantation ; however , a single-unit cord-blood transplant was associated with better platelet recovery and a lower risk of GVHD .
CONCLUSIONS	( Funded by the National Heart , Lung , and Blood Institute and the National Cancer Institute ; ClinicalTrials.gov number , NCT00412360 . )

###24417471
OBJECTIVE	To compare 12-month outpatient healthcare expenditures of at-risk and not-at-risk drinkers aged 60 and older .
METHODS	Secondary analysis of data from Project Senior Health and Alcohol Risk Education , a cluster , randomized trial to test the efficacy of an intervention to reduce at-risk drinking .
METHODS	Seven primary care clinics in or near Santa Barbara , California .
METHODS	Current drinkers aged 60 and older who completed a baseline survey ( N = 2,779 ) and did not receive the study intervention , including 628 at-risk drinkers and 2,151 not-at-risk drinkers .
METHODS	Comparisons of at-risk and not-at-risk drinkers for baseline demographic characteristics , health indicators , alcohol consumption , and adjusted and unadjusted outpatient healthcare expenditures incurred over 12 months after baseline .
RESULTS	At-risk drinkers were younger , more often male , and more likely to be married and had higher education and incomes than not-at-risk drinkers .
RESULTS	Unadjusted 12-month mean outpatient healthcare expenditures were $ 1,333 2,973 for at-risk drinkers and $ 1,417 2,952 for the not-at-risk drinkers .
RESULTS	There were no statistically significant differences in expenditures between groups before and after controlling for sociodemographic and health characteristics .
CONCLUSIONS	In this short-term study , no adjusted differences in healthcare expenditures were observed between at-risk and not-at-risk older drinkers .
CONCLUSIONS	Future study is warranted to determine the role of at-risk drinking in long-term healthcare expenditures in older adults .

###24465561
OBJECTIVE	Examinations today are often computerized and the primary motivation and curriculum is often based on the examinations .
OBJECTIVE	This study aims to test if competition widgets in e-learning quiz modules improve post-test and follow-up test results and self-evaluation .
OBJECTIVE	The secondary aim is to evaluate improvements during the training period comparing test-results and number of tests taken .
METHODS	Two groups were randomly assigned to either a quiz-module with competition widgets or a module without .
METHODS	Pre - , post - and follow up test-results were recorded .
METHODS	Time used within the modules was measured and students reported time studying .
METHODS	Students were able to choose questions from former examinations in the quiz-module .
RESULTS	Students from the competing group were significantly better at both post-and follow-up-test and had a significantly better overall learning efficiency than those from the non-competing group .
RESULTS	They were also significantly better at guessing their post-test results .
CONCLUSIONS	Quiz modules with competition widgets motivate students to become more active during the module and stimulate better total efficiency .
CONCLUSIONS	They also generate improved self-awareness regarding post-test-results .

###24694335
OBJECTIVE	Suboptimal vitamin D status can be corrected by vitamin D supplementation , but individual responses to supplementation vary .
OBJECTIVE	We aimed to examine genetic and nongenetic determinants of change in serum 25-hydroxyvitamin D ( 25 ( OH ) D ) after supplementation .
METHODS	We used data from a pilot randomized controlled trial in which 644 adults aged 60 to 84 years were randomly assigned to monthly doses of placebo , 30 000 IU , or 60 000 IU vitamin D3 for 12 months .
METHODS	Baseline characteristics were obtained from a self-administered questionnaire .
METHODS	Eighty-eight single-nucleotide polymorphisms ( SNPs ) in 41 candidate genes were genotyped using Sequenom MassArray technology .
METHODS	Serum 25 ( OH ) D levels before and after the intervention were measured using the Diasorin Liaison platform immunoassay .
METHODS	We used linear regression models to examine associations between genetic and nongenetic factors and change in serum 25 ( OH ) D levels .
RESULTS	Supplement dose and baseline 25 ( OH ) D level explained 24 % of the variability in response to supplementation .
RESULTS	Body mass index , self-reported health status , and ambient UV radiation made a small additional contribution .
RESULTS	SNPs in CYP2R1 , IRF4 , MC1R , CYP27B1 , VDR , TYRP1 , MCM6 , and HERC2 were associated with change in 25 ( OH ) D level , although only CYP2R1 was significant after adjustment for multiple testing .
RESULTS	Models including SNPs explained a similar proportion of variability in response to supplementation as models that included personal and environmental factors .
CONCLUSIONS	Stepwise regression analyses suggest that genetic variability may be associated with response to supplementation , perhaps suggesting that some people might need higher doses to reach optimal 25 ( OH ) D levels or that there is variability in the physiologically normal level of 25 ( OH ) D.

###25680558
BACKGROUND	The benefit or harm of trabectedin discontinuation in patients with non-progressive soft-tissue sarcoma remains unclear .
BACKGROUND	We report the final analysis of a phase 2 trial investigating the clinical benefit of continuation of trabectedin treatment until progression versus interruption of therapy after six treatment cycles in patients with advanced soft-tissue sarcoma .
METHODS	For this open-label , non-comparative , multicentre , phase 2 study , eligible adult patients with advanced soft-tissue sarcomas , who had previously received doxorubicin-based chemotherapy and were able to receive trabectedin , were enrolled from 14 centres of the French Sarcoma Group .
METHODS	Trabectedin was administered at a dose of 15 mg/m ( 2 ) through a central venous line as a 24-h continuous infusion every 3 weeks .
METHODS	After the initial six cycles of trabectedin , patients who were free from progressive disease were randomly assigned in a 1:1 ratio either to continuous treatment or therapy interruption .
METHODS	Randomisation was done centrally by a computer-generated system using permuted blocks of four patients , stratified by tumour grade and performance status .
METHODS	Patients allocated to the interruption group were allowed to restart trabectedin in case of progressive disease .
METHODS	The primary endpoint was progression-free survival at 6 months after randomisation , analysed by intention to treat .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01303094 .
RESULTS	In 178 evaluable patients , 91 ( 51 % ) patients had not progressed after six cycles .
RESULTS	Of these patients , 53 patients were randomly assigned to the two treatment groups : 27 to the continuation group and 26 to the interruption group .
RESULTS	Overall , patients in the two groups received a similar median number of trabectedin cycles ( continuation group : 11 cycles [ range 6-31 + ] vs interruption group : 11 [ range 6-23 + ] ) .
RESULTS	After randomisation , progression-free survival at 6 months was 519 % ( 95 % CI 319-686 ) in the continuation group versus 231 % ( 94-403 ) in the interruption group ( p = 00200 ) .
RESULTS	The occurrence of treatment-related grade 3 adverse events ( four [ 16 % ] of 25 patients in the continuation group vs three [ 14 % ] of 21 in the interruption group ) and grade 4 adverse events ( one [ 4 % ] vs none ) was similar in both groups .
RESULTS	The most common grade 3 and 4 toxicities were alanine aminotransferase or aspartate aminotransferase increases ( one [ 4 % ] in the interruption group vs three [ 14 % ] in the continuation group ) , neutropenia ( two [ 8 % ] vs two [ 10 % ] ) , and intestinal occlusion ( one [ 4 % ] vs one [ 5 % ] ) .
CONCLUSIONS	We do not recommend trabectedin discontinuation in patients with advanced , doxorubicin-refractory soft-tissue sarcoma who have not progressed after six cycles of treatment .
BACKGROUND	The French National Cancer Institute ( INCa ) and PharmaMar SA .

###25156052
OBJECTIVE	To determine the clinical safety and efficacy of alfaxalone in bitches undergoing caesarean section ( CS ) and their puppies when it is administered for induction of anaesthesia followed by maintenance with isoflurane and oxygen and in conjunction with perioperative pharmaceuticals .
METHODS	A multicentre , randomised , positive-controlled clinical study .
METHODS	A total of 74 bitches were enrolled in the study with 48/74 ( 65 % ) and 26/74 ( 35 % ) receiving alfaxalone and propofol , respectively , for induction of anaesthesia .
METHODS	Bitches were examined prior to induction and monitored during induction , surgery and recovery .
METHODS	Assessments were made for quality of induction , maintenance and recovery from anaesthesia .
METHODS	Assessments were made on pup viability for suction , dorsal flexion , withdrawal and anogenital reflexes .
RESULTS	Of the 48 bitches receiving alfaxalone , 47 ( 98 % ) and 39 ( 81 % ) scored a top score of excellent for induction and anaesthesia effectiveness , respectively .
RESULTS	For the same parameters with propofol in 26 bitches , 23 ( 88 % ) and 17 ( 65 % ) scored excellent .
RESULTS	Average scores for recovery were not different between the two treatment groups with alfaxalone 46/48 ( 96 % ) and 25/26 ( 96 % ) of propofol induced bitches scoring a good or excellent rating .
RESULTS	Bitches tolerated a number of concurrent medications throughout the peri-operative period .
RESULTS	No bitch fatalities were observed in this study .
RESULTS	There were no statistically significant differences between treatment groups for the puppy variables .
RESULTS	Live puppies born by CS to bitches having been administered alfaxalone or propofol had similar survival rates 24h after birth ( i.e. 205/213 ( 96 % ) and 124/131 ( 95 % ) , respectively ) .
CONCLUSIONS	This study confirms the safety and efficacy of alfaxalone for the purpose of anaesthetic induction for CS in the bitch .
CONCLUSIONS	In addition , alfaxalone had a negligible effect on the neonate with > 95 % of puppies alive 24h after the bitch had recovered from anaesthesia with alfaxalone induction .

###25039403
BACKGROUND	Post-operative pain continues to be a major problem .
BACKGROUND	Some previous studies have suggested that patients anaesthetised with propofol have less pain after surgery than those anesthetised with volatiles .
BACKGROUND	However , the results of previous studies are conflicting .
BACKGROUND	We designed a large-scale trial to study , whether propofol or sevoflurane is more analgesic than the other .
BACKGROUND	We measured opioid consumption in the acute post-operative phase after laparoscopic hysterectomy .
METHODS	In a randomised , prospective single-blind trial , we evaluated the consumption of oxycodone and pain intensity in 148 women for 20h after laparoscopic hysterectomy under propofol or sevoflurane anaesthesia .
METHODS	The primary endpoint was the cumulative amount of oxycodone consumed .
METHODS	Secondary endpoints were pain scores [ numeric rating scale ( NRS ) ] at rest and with coughing , severity of nausea and state of sedation .
RESULTS	The consumption of oxycodone and the NRS pain scores did not differ between the groups .
RESULTS	The oxycodone consumed during first 20h after surgery was 42.5 ( 95 % confidence interval 38.3-46 .6 ) mg and 42.8 ( 37.3-48 .4 ) mg in propofol - and sevoflurane-anaesthetised patients , respectively ( P = 0.919 ) .
RESULTS	NRS scores for nausea were higher in the patients receiving sevoflurane during the first 60min in the post-anaesthesia care unit , leading to higher consumption of rescue antiemetics .
RESULTS	Sedation scores differed in favour of sevoflurane only at 4h time point after anaesthesia .
RESULTS	Patient characteristics did not differ .
CONCLUSIONS	In this study , comparing sevoflurane with propofol for maintenance of general anaesthesia , the choice of anaesthetic had no effect on the requirement of oxycodone or intensity of pain after surgery .

###24478129
OBJECTIVE	Infection with the bacterial pathogen Helicobacter pylori ( HP ) clearly results in chronic mucosal inflammation in the stomach and duodenum , which , in turn , might lead to abnormalities in gastroduodenal motility and sensitivity and is the most frequent cause of dyspepsia and peptic disease .
OBJECTIVE	Some studies have shown that there was a correlation between low-grade inflammation as C-reactive protein ( CRP ) and HP infection .
OBJECTIVE	The aim of this study was to investigate the relationship between the presence of gastritis due to HP infection and neutrophil/lymphocyte ratio ( NLR ) , a simple and reliable indicator of inflammation .
METHODS	Fifty patients met the HP criteria and half of them have had severe symptoms and upper endoscopy showed atrophic gastritis , and fifty age - and sex-matched control subjects with gastritis without HP infection were included in this randomized controlled trial .
METHODS	Patients were diagnosed to have HP according to the use of urea breath testing ( UBT ) and multiple biopsies .
METHODS	NLR was calculated from complete blood count at the time of diagnosis and before initiating the treatment to all groups .
RESULTS	Patients with HP infection had significantly higher NLR compared to those without HP .
RESULTS	Moreover , the patients with symptomatic HP and grade 4 gastritis had higher NLR than those asymptomatic with past history of peptic disease ( P 0.007 and P 0.068 , respectively ) .
RESULTS	Although NLR increased as the severity of gastritis and HP symptoms increased ( r = 0.564 , P < 0.001 ) , Receiver operating characteristic ( ROC ) Curve analysis was performed .
RESULTS	The cut-off level for NLR with optimal sensitivity and specificity was calculated as 1.82 ( area under curve [ AUC ] = 0.825 [ 0.753-0 .884 ] , P < 0.001 ) .
CONCLUSIONS	The present study indicated , for the first time , a significant correlation between HP infection and inflammation on the basis of NLR , a simple and reliable indicator of inflammation .
CONCLUSIONS	Furthermore , there is an increase in NLR as the severity of gastritis with HP increases .
CONCLUSIONS	This elevated ratio gets normalized with treatment .

###24638119
BACKGROUND	Only 63 % of the US population aged 50-75 years is adherent with recommended colorectal cancer ( CRC ) screening guidelines .
BACKGROUND	Efforts are needed to increase screening for CRC .
METHODS	We evaluated a quality improvement intervention conducted in 2010 at Group Health in Washington State to assess the use of interactive voice response ( IVR ) systems to improve CRC screening .
METHODS	Eligible members were aged 50-81 years , received primary care from a contracted physician , and were due for CRC screening .
METHODS	A total of 13,279 members were identified and randomly assigned to either : ( 1 ) an intervention with IVR to encourage CRC screening ( n = 10,000 ) , or ( 2 ) usual care ( n = 3279 ) .
METHODS	The primary outcome was receipt of any recommended CRC screening test at 6 months postintervention or index date .
METHODS	We used Cox proportional hazards to model time until receipt of CRC screening at 6 months .
RESULTS	Adherence to CRC screening was 10.0 % in the intervention arm and 7.8 % in the usual care arm at 6 months .
RESULTS	Randomization to the IVR intervention arm was associated with a 32 % increased likelihood of receiving CRC screening ( hazard ratio = 1.32 ; 95 % confidence interval , 1.14 , 1.52 ) compared with usual care .
RESULTS	The difference in CRC screening uptake was apparent by 3 months and persisted for 12 months postintervention ( log-rank test , P = 0.0012 ) .
CONCLUSIONS	Our analysis provides `` real-world '' evidence that IVR is effective when delivered by a commercial health plan , and may be a useful tool for increasing adherence to screening guidelines among patients outside an integrated care practice .

###25095718
BACKGROUND	Cholangiocellular carcinoma is the second most common primary liver cancer after hepatocellular carcinoma .
BACKGROUND	Over the last 30years , the incidence of intrahepatic cholangiocellular carcinoma has risen continuously worldwide .
BACKGROUND	Meanwhile , the intrahepatic cholangiocellular carcinoma has become more common than the extrahepatic growth type and currently accounts for 10-15 % of all primary hepatic malignancies .
BACKGROUND	Intrahepatic cholangiocellular carcinoma is typically diagnosed in advanced stages due to late clinical symptoms and an absence of classic risk factors .
BACKGROUND	A late diagnosis precludes curative surgical resection .
BACKGROUND	There is evidence that transarterial chemoembolization leads to better local tumor control and prolongs survival compared to systemic chemotherapy .
BACKGROUND	New data indicates that selective internal radiotherapy , also referred to as radioembolization , provides promising results for treating intrahepatic cholangiocellular carcinoma .
METHODS	This pilot study is a randomized , controlled , single center , phase II trial .
METHODS	Twenty-four patients with intrahepatic cholangiocellular carcinoma will be randomized in a 1:1 ratio to receive either chemoembolization or radioembolization .
METHODS	Randomization will be stratified according to tumor load .
METHODS	Progression-free survival is the primary endpoint ; overall survival and time to progression are secondary endpoints .
METHODS	To evaluate treatment success , patients will receive contrast enhanced magnetic resonance imaging every 3months .
CONCLUSIONS	Currently , chemoembolization is routinely performed in many centers instead of systemic chemotherapy for treating intrahepatic cholangiocellular carcinoma confined to the liver .
CONCLUSIONS	Recently , radioembolization has been increasingly applied to cholangiocellular carcinoma as second line therapy after TACE failure or even as an alternative first line therapy .
CONCLUSIONS	Nonetheless , no randomized studies have compared radioembolization and chemoembolization .
CONCLUSIONS	Considering all this background information , we recognized a strong need for a randomized controlled trial ( RCT ) to compare the two treatments .
CONCLUSIONS	Therefore , the present protocol describes the design of a RCT that compares SIRT and TACE as the first line therapy for inoperable CCC confined to the liver .
BACKGROUND	ClinicalTrials.gov , Identifier : NCT01798147 , registered 16th of February 2013 .

###25458662
BACKGROUND	Exercise training increasingly is recommended as an important part of the management of cardiovascular disease .
BACKGROUND	However , few studies have evaluated the effectiveness of exercise training in patients with chronic kidney disease ( CKD ) , and those that have included very selective populations .
METHODS	Analysis of secondary outcomes of a randomized controlled trial , with participants randomly assigned to either lifestyle intervention or usual care ( control ) .
METHODS	Patients with CKD stages 3 to 4 and one or more uncontrolled cardiovascular risk factor were recruited from an outpatient clinic at a large tertiary hospital .
METHODS	Lifestyle intervention included access to multidisciplinary care through a nurse practitioner-led CKD clinic , exercise training , and a lifestyle program .
METHODS	The exercise training was a 2-phased program in which participants received 8 weeks of supervised training before commencing 10 months of home-based training .
METHODS	Efficacy , as assessed by metabolic equivalent tasks ( METs ) , 6-minute walk distance , Timed Get-Up-and-Go test , grip strength , and anthropomorphic measures ; adherence , as assessed by self-reported physical activity ; and safety , as assessed by reported serious adverse events , were recorded .
RESULTS	83 patients were randomly assigned and 72 patients completed follow-up testing ( intervention , n = 36 ; control , n = 36 ) .
RESULTS	The intervention resulted in a significant improvement in METs ( pre , 7.23.3 ; post , 9.73.6 ) , 6-minute walk distance ( pre , 485110m ; post , 53982m ) , and body mass index ( pre , 32.56.7 kg/m ( 2 ) ; post , 31.97.3 kg/m ( 2 ) ) .
RESULTS	Reported physical activity levels significantly increased in the intervention group at 6 months , but decreased at 12 months .
RESULTS	There were no serious adverse events related to the exercise training .
CONCLUSIONS	This study was not powered to evaluate the safety of exercise training on serious adverse events .
CONCLUSIONS	The findings from the present study suggest that an exercise program that includes a supervised and home-based training phase is effective , adhered to , and safe in patients with CKD .

###24766999
BACKGROUND	There is a paucity of evidence for outcome predictors in patients with major depressive disorder ( MDD ) not responding to initial antidepressant therapy ( ADT ) .
BACKGROUND	This post-hoc analysis evaluated whether MDD severity affects response to adjunctive aripiprazole .
METHODS	Data from 3 randomized , double-blind , placebo-controlled trials of adjunctive aripiprazole in adults with MDD and inadequate response to 1 to 3 ADT trials were pooled and stratified based on Montgomery-sberg Depression Rating Scale ( MADRS ) total score ( mild , 24 ; moderate , 25-30 ; severe , 31 ) .
METHODS	Treatment differences in change in MADRS total score and rates of response ( 50 % MADRS improvement ) and remission ( response with MADRS total score 10 ) were analyzed at endpoint .
METHODS	Adverse events were assessed within each subgroup .
RESULTS	Aripiprazole produced greater improvement than placebo in the MADRS total score regardless of MDD severity at baseline ( between-treatment difference [ 95 % CI ] : mild , -2.5 [ -4.0 to -1.1 ] ; moderate , -3.2 [ -4.9 to -1.6 ] ; severe , -4.5 [ -6.8 to -2.2 ] ) .
RESULTS	Compared with placebo , adjunctive aripiprazole increased the likelihood of response in all subgroups ( risk ratio [ 95 % CI ] : mild , 1.50 [ 1.15 , 1.95 ] ; moderate , 1.51 [ 1.09 , 2.11 ] ; severe , 1.95 [ 1.23 , 3.10 ] ) .
RESULTS	Common treatment-emergent adverse events included akathisia and restlessness .
CONCLUSIONS	The original studies were not designed to assess the efficacy of adjunctive aripiprazole by baseline severity , and this post-hoc analysis was not powered to evaluate differences in severity subgroups .
CONCLUSIONS	In patients who failed to respond to initial ADT , adjunctive aripiprazole was more effective than placebo in mild , moderate , and severe MDD strata .
BACKGROUND	ClinicalTrial.gov : NCT00095823 , NCT00105196 , and NCT00095758 .

###25713916
OBJECTIVE	This study aims to estimate the value of embryonal natural orifice transluminal endoscopic surgery ( ENOTES ) as a treatment for severe acute pancreatitis ( SAP ) complicated by abdominal compartment syndrome ( ACS ) .
METHODS	The patients who were randomized into ENOTES group and surgery group underwent ENOTES and laparotomy , respectively .
METHODS	The Efficacy and complications of these two treatments were compared .
RESULTS	Enterocinesia was observed earlier in patients of ENOTES group than that of surgery group .
RESULTS	Acute Physiology and Chronic Health Evaluation II ( APACHE II ) score of patients in ENOTES group was superior to that of surgery group on the 1st , 3rd and 5th day after treatment ( P < 0.05 ) .
RESULTS	The cure rate was 96.87 % in ENOTES group , which was statistically different from 78.12 % in surgery group ( P < 0.05 ) .
RESULTS	Significant differences in complications and mortality were observed between two groups ( P < 0.01 ) .
CONCLUSIONS	Compared with surgical abdominal decompression , ENOTES and flexible endoscope therapy is a more effective and minimal invasive surgery with less complications .

###25562379
OBJECTIVE	This study addresses the extent to which DSM-IV and DSM-5 definitions of acute stress disorder ( ASD ) predict subsequent posttraumatic stress disorder ( PTSD ) and related psychiatric disorders following trauma .
METHODS	Patients with randomized admissions to 5 hospitals across Australia ( N = 596 ) were assessed in hospital and reassessed for PTSD at 3 ( n = 508 ) , 12 ( n = 426 ) , 24 ( n = 439 ) , and 72 ( n = 314 ) months using the Clinician-Administered PTSD Scale ; DSM-IV definition of PTSD was used at each assessment , and DSM-5 definition was used at 72 months .
METHODS	The Mini-International Neuropsychiatric Interview ( MINI ) was used at each assessment to assess anxiety , mood , and substance use disorders .
RESULTS	Forty-five patients ( 8 % ) met DSM-IV criteria , and 80 patients ( 14 % ) met DSM-5 criteria for ASD .
RESULTS	PTSD was diagnosed in 93 patients ( 9 % ) at 3 , 82 patients ( 10 % ) at 12 , 100 patients ( 12 % ) at 24 , and 26 patients ( 8 % ) at 72 months ; 19 patients ( 6 % ) met DSM-5 criteria for PTSD at 72 months .
RESULTS	Comparable proportions of those diagnosed with ASD developed PTSD using DSM-IV ( 3 months = 46 % , 12 months = 39 % , 24 months = 32 % , and 72 months = 25 % ) and DSM-5 ( 43 % , 42 % , 33 % , and 24 % ) ASD definitions .
RESULTS	Sensitivity was improved for DSM-5 relative to DSM-IV for depression ( 0.18 vs 0.30 ) , panic disorder ( 0.19 vs 0.41 ) , agoraphobia ( 0.14 vs 0.40 ) , social phobia ( 0.12 vs 0.44 ) , specific phobia ( 0.24 vs 0.58 ) , obsessive-compulsive disorder ( 0.17 vs 0.47 ) , and generalized anxiety disorder ( 0.20 vs 0.47 ) .
RESULTS	More than half of participants with DSM-5-defined ASD had a subsequent disorder .
CONCLUSIONS	The DSM-5 criteria for ASD results in better identification of people who will subsequently develop PTSD or another psychiatric disorder relative to the DSM-IV criteria .
CONCLUSIONS	Although prediction is modest , it suggests that the new ASD diagnosis can serve a useful function in acute trauma settings for triaging those who can benefit from either early intervention or subsequent monitoring .

###24553480
OBJECTIVE	The primary objective of this study was to compare the bioavailability of paracetamol , phenylephrine hydrochloride and guaifenesin in a new oral syrup with an established oral reference product .
OBJECTIVE	The secondary objective was to compare the safety of the new syrup and the reference product .
METHODS	This was a single-centre , open-label , randomized , reference-replicated , crossover study .
METHODS	Healthy adult volunteers received one dose of syrup and two separate doses of a reference oral liquid formulation in a randomized sequence over three study periods , with a washout interval of 7 days between study periods .
METHODS	Blood samples were taken regularly postdose and analysed for paracetamol , phenylephrine hydrochloride and guaifenesin concentrations ; adverse events were recorded .
RESULTS	This study enrolled 45 subjects .
RESULTS	For paracetamol and guaifenesin , the syrup and reference product were considered to be bioequivalent .
RESULTS	Bioequivalence was not shown for phenylephrine hydrochloride .
RESULTS	All adverse events were mild or moderate , most of which were considered formulation related .
CONCLUSIONS	The syrup did not reach bioequivalence with the reference product , as bioequivalence could not be shown for phenylephrine hydrochloride .
CONCLUSIONS	This may be due to differences in the excipients between the two products .
CONCLUSIONS	Both the syrup and the reference product had a good safety profile and were well tolerated .

###25666288
BACKGROUND	A randomised , double-blind clinical trial was conducted comparing the efficacy of tranexamic acid ( TXA ) as a single intravenous bolus or a continuous infusion to patients undergoing total knee arthroplasty ( TKA ) .
BACKGROUND	Study hypothesis was that a second dose of TXA would not offer any clinical benefits over the single infusion .
METHODS	One hundred and six patients were randomised to a single intraoperative dose of 30 mg/kg tranexamic acid ( OS group , n = 54 ) , or to a loading dose of 10 mg/kg tranexamic acid followed 2 h later by a continuous 2 mg/kg/h infusion for 20 h ( OD group , n = 52 ) .
METHODS	The primary outcome was blood loss calculated from haematological values and perioperative transfusions .
METHODS	Secondary outcomes included the occurrence of major complications within the first postoperative year .
RESULTS	All patients completed tranexamic acid therapy without adverse events .
RESULTS	The mean blood loss was 1,148 585 ml in group OS and 1,196 614 ml in group OD ( p = 0.68 ) .
RESULTS	No patients received a transfusion .
RESULTS	There were no occurrences of major complications up to 6-weeks follow-up .
CONCLUSIONS	The study demonstrated that a single bolus of tranexamic acid 30 mg/kg is as effective as a continuous infusion in patients undergoing tranexamic acid .
CONCLUSIONS	The single application of tranexamic acid as part of routine care is recommended .

###24401481
OBJECTIVE	To assess the efficacy of trabeculectomy with a biodegradable Ologen implant ( OLO ) versus mitomycin C ( MMC ) in patients in a prospective randomized clinical trial .
METHODS	In the MMC group ( 15 patients ) , trabeculectomy was performed according to standard protocols .
METHODS	In the OLO group ( 15 patients ) after standard trabeculectomy , the implant was positioned on top of the scleral flap , and no MMC was applied .
RESULTS	Mean preoperative intraocular pressure ( IOP ) levels ( OLO : 28.0 9.4 ; MMC : 23.9 5.0 mm Hg ; p = 0.21 ) and medication score ( OLO : 3.4 1.6 ; MMC : 3.6 1.5 ; p = 0.56 ) were comparable in both groups .
RESULTS	One year after surgery , the mean IOP was 15.9 4.5 mm Hg in the OLO group ( p < 0.01 , 43 % reduction ) and 11.0 2.6 mm Hg in the MMC group ( p < 0.01 , 54 % reduction ) .
RESULTS	The surgical success rate 12 months after surgery was 93.3 % in the MMC group and 40 % in the OLO group ( p = 0.01 ) .
CONCLUSIONS	With the atelocollagen-glycosaminoglycan matrix OLO it was not possible to reach the surgical success rate and pressure reduction achieved in the MMC group .

###24378958
OBJECTIVE	Serum matrix metalloproteinases ( MMP-8 , MMP-7 ) and their regulators may be associated with the risk of incident cardiovascular disease events .
OBJECTIVE	Doxycycline can be used as matrix metalloproteinase ( MMP ) inhibitor independent of its antimicrobial activity .
OBJECTIVE	We aimed to investigate serum inflammatory biomarkers during 4 months of doxycycline therapy in coronary bypass patients .
METHODS	Thirty-one non-smoking men who had previous coronary bypass surgery were randomly assigned to receive placebo or 100 mg doxycycline daily for 4 months .
METHODS	Serum samples were collected at baseline before the treatment , and at 2 , 4 , and 10 months .
METHODS	Serum levels of MMP-7 , tissue inhibitor of matrix metalloproteinase ( TIMP ) -1 , myeloperoxidase , and neutrophil elastase were analyzed with enzyme-linked immunosorbent assay , MMP-8 by immunofluorometric assay , and C-reactive protein by rate nephelometry .
RESULTS	At baseline , no significant differences existed between the two groups .
RESULTS	Serum levels of MMP-8 , MMP-7 , and MMP-8 / TIMP-1 were and remained lower ( p = 0.034 , p = 0.041 , and NS ) in the doxycycline group relative to the placebo group at 4 months of follow-up .
CONCLUSIONS	Doxycycline decreases the systemic inflammatory burden in patients with myocardial infarction and especially down-regulates MMP-7 , MMP-8 , and MMP-8 / TIMP-1 .
CONCLUSIONS	Doxycycline might prevent or reduce the risk of secondary myocardial infarctions by providing a systemic anti-proteolytic and - inflammatory shield .

###24726628
BACKGROUND	In epidemiologic research , incident chronic kidney disease ( CKD ) commonly is determined by laboratory tests performed at planned study visits .
BACKGROUND	Given the morbidity and mortality associated with CKD , persons with incident disease may be less likely to attend scheduled visits , affecting observed associations .
BACKGROUND	The objective of this study was to quantify loss to follow-up by CKD status and determine whether supplementation with diagnostic code data improves capture of incident CKD .
METHODS	Prospective cohort study .
METHODS	11,560 participants in the Atherosclerosis Risk in Communities ( ARIC ) Study underwent continuous surveillance for hospitalizations and death from baseline visit ( 1996-1999 ) to follow-up visit ( 2011-2013 ) .
METHODS	A subset of hospitalizations in Washington County , MD , was used in diagnostic code validation ( n = 2,540 ) .
METHODS	Baseline demographics and comorbid conditions .
RESULTS	Incident CKD stage 3 ascertained by follow-up visit ( visit-based definition ) or hospitalization surveillance ( hospitalization-based definition ) .
METHODS	Visit-based definition : 25 % decline from baseline estimated glomerular filtration rate to < 60 mL/min/1 .73 m2 at follow-up visit ; hospitalization-based definition : hospitalization CKD diagnostic code .
RESULTS	Of 11,560 participants , 5,951 attended the follow-up visit and 9,264 were hospitalized .
RESULTS	Never-hospitalized participants were younger , more often female , and had fewer comorbid conditions ; 73.5 % attended the follow-up visit .
RESULTS	Incident CKD stage 3 occurred in 1,172 participants by the visit-based definition ( 251 were never hospitalized ) and 1,078 participants by the hospitalization-based definition ( 237 attended the follow-up study visit ) .
RESULTS	Sensitivity of the hospitalization-based CKD definition was 35.5 % ( 95 % CI , 31.6 % -39.7 % ) ; specificity was 95.7 % ( 95 % CI , 94.2 % -96.8 % ) .
RESULTS	Sensitivity was higher with later time period , older participant age , and baseline prevalent diabetes and CKD .
CONCLUSIONS	A subset of hospitalizations was used for validation ; 15-year gap between study visits .
CONCLUSIONS	The sensitivity of diagnostic code-identified CKD is low and varies by certain factors ; however , supplementing a visit-based definition with hospitalization information can increase disease identification during periods of follow-up without study visits .

###24532471
OBJECTIVE	We conducted this study with the aim of demonstrating the feasibility and efficacy of speed-feedback therapy with a bicycle ergometer on cognitive function in elderly cancer patients .
METHODS	The subjects were patients with breast or prostate cancer who were 65years of age or over .
METHODS	Among 146 patients , 78 were randomly assigned to the intervention group ( n = 38 ) or the control group ( n = 40 ) .
METHODS	The intervention group received speed-feedback therapy with a bicycle ergometer once a week for four successive weeks .
METHODS	The control group was advised to spend the 4-week period engaged in their routine activities .
METHODS	Evaluations were carried out at the baseline and 4weeks after the baseline ( week 4 ) using the Frontal Assessment Battery , the Barthel Index , the Lawton and Brody Instrumental Activities of Daily Living , and the Functional Assessment of Cancer Therapy-General ver .4 .
METHODS	Data were analyzed by a two-way repeated-measures analysis of variance .
RESULTS	The mean score of Frontal Assessment Battery for the intervention group was higher than that for the control group at week 4 .
RESULTS	In addition to significant main effects of time and group , we also found a significant interaction between the two groups ( p = 0.006 ) .
RESULTS	Moreover , all of the subjects in the intervention group could complete all the four sessions of therapy without any pain or distress .
CONCLUSIONS	These results suggest that speed-feedback therapy with a bicycle ergometer may be feasible as well as effective for improving the cognitive function in elderly cancer patients .

###25155134
BACKGROUND	Problems with intravenous patient-controlled analgesia ( IV PCA ) are well known , including invasive route of delivery and pump programming errors .
BACKGROUND	The primary objective of this study was to evaluate patient satisfaction with a novel sublingual sufentanil PCA system ( sufentanil sublingual tablet system 15mcg with a 20-minute lockout interval ; SSTS ) to IV PCA morphine sulfate 1mg with a 6-minute lockout interval ( IV PCA MS ) for the management of acute postoperative pain .
METHODS	This was a randomized , open-label , 48-hour non-inferiority study with optional extension to 72hours at 26 U.S. sites enrolling patients scheduled for elective major open abdominal or orthopedic ( hip or knee replacement ) surgery .
METHODS	The primary outcome measure was the proportion of patients who responded `` good '' or `` excellent '' ( collectively `` success '' ) at the 48-hour timepoint on the Patient Global Assessment of method of pain control ( PGA48 ) .
RESULTS	A total of 357 patients received study drug and 78.5 % vs. 65.6 % of patients achieved PGA48 `` success '' for SSTS vs. IV PCA MS , respectively , demonstrating non-inferiority ( P < 0.001 using the one-side Z-test against the non-inferiority margin ) as well as statistical superiority for treatment effect ( P = 0.007 ) .
RESULTS	Patients using SSTS reported more rapid onset of analgesia and patient and nurse ease of care and satisfaction scores were higher than IV PCA MS. Adverse events were similar between the 2 groups ; however , SSTS had fewer patients experiencing oxygen desaturations below 95 % compared to IV PCA MS ( P = 0.028 ) .
CONCLUSIONS	Sufentanil sublingual tablet system is a promising new analgesic technology that may address some of the concerns with IV PCA .

###25183313
BACKGROUND	As current dengue control strategies have been shown to be largely ineffective in reducing dengue in school-aged children , novel approaches towards dengue control need to be studied .
BACKGROUND	Insecticide-impregnated school uniforms represent an innovative approach with the theoretical potential to reduce dengue infections in school children .
OBJECTIVE	This study took place in the context of a randomised control trial ( RCT ) to test the effectiveness of permethrin-impregnated school uniforms ( ISUs ) for dengue prevention in Chachoengsao Province , Thailand .
OBJECTIVE	The objective was to assess the acceptability of ISUs among parents , teachers , and principals of school children involved in the trial .
METHODS	Quantitative and qualitative tools were used in a mixed methods approach .
METHODS	Class-clustered randomised samples of school children enrolled in the RCT were selected and their parents completed 321 self-administered questionnaires .
METHODS	Descriptive statistics and logistic regression were used to analyse the quantitative data .
METHODS	Focus group discussions and individual semi-structured interviews were conducted with parents , teachers , and principals .
METHODS	Qualitative data analysis involved content analysis with coding and thematic development .
RESULTS	The knowledge and experience of dengue was substantial .
RESULTS	The acceptability of ISUs was high .
RESULTS	Parents ( 87.3 % ; 95 % CI 82.9-90 .8 ) would allow their child to wear an ISU and 59.9 % ( 95 % CI 53.7-65 .9 ) of parents would incur additional costs for an ISU over a normal uniform .
RESULTS	This was significantly associated with the total monthly income of a household and the educational level of the respondent .
RESULTS	Parents ( 62.5 % ; 95 % CI 56.6-68 .1 ) indicated they would be willing to recommend ISUs to other parents .
CONCLUSIONS	Acceptability of the novel tool of ISUs was high as defined by the lack of concern along with the willingness to pay and recommend .
CONCLUSIONS	Considering issues of effectiveness and scalability , assessing acceptability of ISUs over time is recommended .

###25138990
OBJECTIVE	To evaluate the efficacy and outcomes of PlasmaKinetic urethrotomy against cold knife direct vision internal urethrotomy in terms of recurrence rates .
METHODS	A total of 136 male patients with urethral strictures were enrolled into the study .
METHODS	The patients were allocated to cold knife or PlasmaKinetic urethrotomy groups sequentially by using computer-generated numbers .
METHODS	Group A ( PlasmaKinetic ) and group B ( cold knife ) included 70 and 66 patients , respectively .
METHODS	All patients were reevaluated at the 3rd , 9th and 18th month postoperatively with uroflowmetry .
RESULTS	Group A patients had a postoperative 3rd-month maximum flow rate value of 16.09 ml/s , whereas this same parameter was 15.15 ml/s in group B ( p < 0.05 ) .
RESULTS	The urethral stricture recurrence rate up to the 9-month period was statistically significant for group A ( 14 % ) compared with group B ( 30 % ) .
RESULTS	When we compared the recurrence rates of these groups from postoperative day 1 up to the 18th month , the results were 37 % for group A and 33 % for group B ( p > 0.05 ) .
CONCLUSIONS	PlasmaKinetic urethrotomy provides a better recurrence-free rate during the early period compared with conventional cold knife therapy .
CONCLUSIONS	Nevertheless , the outcome of the stricture did not change and fibrotic tissue reformed between the 9th and the 18th month .

###24856612
OBJECTIVE	This analysis evaluated HbA1c-adjusted hypoglycemia risk with glargine versus neutral protamine Hagedorn ( NPH ) over a 5-year study in patients with Type 2 diabetes mellitus ( T2DM ) .
OBJECTIVE	Clinical significance was assessed using number needed to harm ( NNH ) to demonstrate the risk of one additional patient experiencing at least one hypoglycemic event .
METHODS	Individual patient-level data for symptomatic documented hypoglycemia and HbA1c values from a 5-year randomized study comparing once-daily glargine ( n = 513 ) with twice-daily NPH ( n = 504 ) were analyzed .
METHODS	Symptomatic hypoglycemia was categorized according to concurrent self-monitoring blood glucose levels and need for assistance .
METHODS	Hypoglycemic events per patient-year as a function of HbA1c were fitted by negative binomial regression using treatment and HbA1c at endpoint as independent variables .
METHODS	An estimate of NNH was derived from logistic regression models .
RESULTS	The cumulative number of symptomatic hypoglycemia events was consistently lower with glargine compared with NPH over 5years .
RESULTS	Compared with twice-daily NPH , once-daily glargine treatment resulted in significantly lower adjusted odds ratios ( OR ) for all daytime hypoglycemia ( OR 0.74 ; p = 0.030 ) and any severe event ( OR 0.64 ; p = 0.035 ) , representing a 26 % and 36 % reduction in the odds of daytime and severe hypoglycemia , respectively .
RESULTS	Our model predicts that , if 25 patients were treated with NPH instead of glargine , then one additional patient would experience at least one severe hypoglycemic event .
CONCLUSIONS	This analysis of long-term insulin treatment confirms findings from short-term studies and demonstrates that glargine provides sustained , clinically meaningful reductions in risk of hypoglycemia compared with NPH in patients with T2DM .

###24517173
OBJECTIVE	To develop a framework for integrating pharmacogenetics with clinical pharmacokinetics for personalized oxycodone dosing based on a patient 's CYP2D6 phenotype .
METHODS	Randomized , crossover , double-blind , placebo-controlled .
METHODS	Subjects were genotyped as CYP2D6 ultra-rapid metabolizer , extensive metabolizer , or poor metabolizer phenotypes .
METHODS	Five subjects from each phenotype were randomly selected for inclusion in our study .
METHODS	Studies were performed in silico .
METHODS	The subjects were male , age 26 years , height 181.2 cm , and weight 76.3 kg .
METHODS	They were healthy without comorbidities , and their medical examinations were normal .
METHODS	The trajectories of phenotype-specific plasma oxycodone concentration-time profiles were analyzed using weighted nonlinear least-squares regression with WinSAAM software .
METHODS	A global two-stage population-based model data analysis procedure was used to analyze the studies .
METHODS	Clinical pharmacokinetics were calculated using the R package cpk , eliminating the need to perform hand-calculations .
RESULTS	Our study shows how clinicians can reduce risk and increase effectiveness for oxycodone dosing by ( 1 ) determining the patient 's likely metabolic response through testing a patient 's CYP2D6 phenotype , and ( 2 ) calculating clinical pharmacokinetics specific to the patient 's CYP2D6 phenotype to design a personalized oxycodone dosing regimen .
CONCLUSIONS	Personalized oxycodone dosing is a new tool for a clinician treating chronic pain patients requiring oxycodone .
CONCLUSIONS	By expressing a patient 's CYP2D6 phenotype pharmacokinetically , a clinician ( at least theoretically ) can improve the safety and efficacy of oxycodone and decrease the risk for iatrogenically induced overdose or death .
CONCLUSIONS	Pharmacokinomics provides a general framework for the integration of pharmacogenetics with clinical pharmacokinetics into clinical practice for gene-based prescribing .

###26051365
BACKGROUND	New therapeutic options are needed for patients with psoriasis .
BACKGROUND	Tofacitinib , an oral Janus kinase inhibitor , is being investigated as a treatment for moderate-to-severe chronic plaque psoriasis .
BACKGROUND	In this study , we aimed to compare two tofacitinib doses with high-dose etanercept or placebo in this patient population .
METHODS	In this phase 3 , randomised , multicentre , double-dummy , placebo-controlled , 12-week , non-inferiority trial , adult patients with chronic stable plaque psoriasis ( for 12 months ) who were candidates for systemic or phototherapy and had a Psoriasis Area and Severity Index ( PASI ) score of 12 or higher and a Physician 's Global Assessment ( PGA ) of moderate or severe , and had failed to respond to , had a contraindication to , or were intolerant to at least one conventional systemic therapy , were enrolled from 122 investigational dermatology centres worldwide .
METHODS	Eligible patients were randomly assigned in a 3:3:3:1 ratio to receive tofacitinib 5 mg or 10 mg twice daily at about 12 h intervals , etanercept 50 mg subcutaneously twice weekly at about 3-4 day intervals , or placebo .
METHODS	Randomisation was done by a computer-generated randomisation schedule , and all patients and study personnel were masked to treatment assignment .
METHODS	The co-primary endpoints were the proportion of patients at week 12 with at least a 75 % reduction in the PASI score from baseline ( PASI75 response ) and the proportion of patients achieving a PGA score of `` clear '' or `` almost clear '' ( PGA response ) , analysed in the full analysis set ( all patients who were randomised and received at least one dose of study drug ) .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01241591 .
RESULTS	Between Nov 29 , 2010 , and Sept 13 , 2012 , we enrolled 1106 eligible adult patients with chronic plaque psoriasis and randomly assigned them to the four treatment groups ( 330 to tofacitinib 5 mg twice daily , 332 to tofacitinib 10 mg twice daily , 336 to etanercept 50 mg twice weekly , and 108 to placebo ) .
RESULTS	Of these patients , 1101 actually received their assigned study medication ( 329 in the tofactinib 5 mg group , 330 in the tofacitinib 10 mg group , 335 in the etanercept group , and 107 in the placebo group ) .
RESULTS	At week 12 , PASI75 responses were recorded in 130 ( 395 % ) of 329 patients in the tofacitinib 5 mg group , 210 ( 636 % ) of 330 in the tofacitinib 10 mg group , 197 ( 588 % ) of 335 in the etanercept group , and six ( 56 % ) of 107 in the placebo group .
RESULTS	A PGA response was achieved by 155 ( 471 % ) of 329 patients in the tofacitinib 5 mg group , 225 ( 682 % ) of 330 in the tofacitinib 10 mg group , 222 ( 663 % ) of 335 in the etanercept group , and 16 ( 150 % ) of 107 in the placebo group .
RESULTS	The rate of adverse events was similar across the four groups , with serious adverse events occurring in seven ( 2 % ) of 329 patients in the tofacitinib 5 mg group , five ( 2 % ) of 330 in the tofacitinib 10 mg group , seven ( 2 % ) of 335 in the etanercept group , and two ( 2 % ) of 107 in the placebo group .
RESULTS	Three ( 1 % ) of 329 patients in the tofacitinib 5 mg group , ten ( 3 % ) of 330 in the tofacitinib 10 mg group , 11 ( 3 % ) of 335 in the etanercept group , and four ( 4 % ) of 107 patients in the placebo group discontinued their assigned treatment because of adverse events .
CONCLUSIONS	In patients with moderate-to-severe plaque psoriasis , the 10 mg twice daily dose of tofacitinib was non-inferior to etanercept 50 mg twice weekly and was superior to placebo , but the 5 mg twice daily dose did not show non-inferiority to etanercept 50 mg twice weekly .
CONCLUSIONS	The adverse event rates over 12 weeks were similar for tofacitinib and etanercept .
CONCLUSIONS	This study indicates that in the future tofacitinib could provide a convenient and well-tolerated therapeutic option for patients with moderate-to-severe plaque psoriasis .
BACKGROUND	Pfizer Inc. .

###24357642
BACKGROUND	This study examines the effect of progressive increases in footwear minimalism on injury incidence and pain perception in recreational runners .
METHODS	One hundred and three runners with neutral or mild pronation were randomly assigned a neutral ( Nike Pegasus 28 ) , partial minimalist ( Nike Free 3.0 V2 ) or full minimalist shoe ( Vibram 5-Finger Bikila ) .
METHODS	Runners underwent baseline testing to record training and injury history , as well as selected anthropometric measurements , before starting a 12-week training programme in preparation for a 10km event .
METHODS	Outcome measures included number of injury events , Foot and Ankle Disability ( FADI ) scores and visual analogue scale pain rating scales for regional and overall pain with running .
RESULTS	99 runners were included in final analysis with 23 injuries reported ; the neutral shoe reporting the fewest injuries ( 4 ) and the partial minimalist shoe ( 12 ) the most .
RESULTS	The partial minimalist shoe reported a significantly higher rate of injury incidence throughout the 12-week period .
RESULTS	Runners in the full minimalist group reported greater shin and calf pain .
CONCLUSIONS	Running in minimalist footwear appears to increase the likelihood of experiencing an injury , with full minimalist designs specifically increasing pain at the shin and calf .
CONCLUSIONS	Clinicians should exercise caution when recommending minimalist footwear to runners otherwise new to this footwear category who are preparing for a 10km event .

###25796693
OBJECTIVE	To assess the clinical effect and safety of the Chinese medicine Longbishu Capsule combined with mesylate doxazosin in the treatment of benign prostatic hyperplasia ( BPH ) of the kidney deficiency and blood stagnation type .
METHODS	This was a randomized , double-blind , double-simulation control study .
METHODS	We equally assigned 60 men diagnosed with BPH of the kidney deficiency and blood stagnation type to an experimental and a control group , the former treated with mesylate doxazosin plus Longbishu Capsule and the latter with mesylate doxazosin plus placebo .
METHODS	We compared the International Prostate Symptom Score ( IPSS ) , quality of life ( QOL ) , Chinese symptom score ( CSS ) , maximal urinary flow rate ( Qmax ) , and prostate volume between the two groups of patients before and after 6 months of medication .
RESULTS	After treatment , there were 5 cured cases , 13 markedly effective cases , 9 effective cases , 1 ineffective case , and 2 eliminated cases in the experimental group , as compared with 2 cured cases , 8 markedly effective cases , 10 effective cases , 7 ineffective cases , and 3 eliminated cases in the control group .
RESULTS	The total effectiveness rate was obviously higher in the former ( 96.4 % ) than in the latter ( 74.1 % ) .
RESULTS	IPSS , Qmax , and CSS were improved in both of the groups after medication , even more significantly in the experimental than in the control group ( IPSS : 15.22 2.98 vs 18.15 5.88 , P < 0.05 ; Qmax : [ 13.56 2.26 ] ml/s vs [ 11.78 2.97 ] ml/s , P < 0.05 ; CSS : 6.18 2.13 vs 9.52 3.15 , P < 0.05 ) .
RESULTS	Because of the difference in the QOL score between the two groups at the baseline ( P = 0.038 < 0.05 ) , no more comparison was made in this aspect after treatment .
CONCLUSIONS	The combination of Longbishu Capsule with mesylate doxazosin is safe and effective for the treatment of BPH .

###25626851
OBJECTIVE	Optimal management of knee osteoarthritis requires a combination of pharmacological and non-pharmacological methods .
OBJECTIVE	The use of lateral wedge insoles to treat medial knee osteoarthritis is recommended , but there is still controversy about its efficacy .
OBJECTIVE	The purpose of this study was to ascertain whether the use of lateral wedge insoles can diminish pain and improve function in patients with medial knee osteoarthritis .
METHODS	Prospective randomized trial conducted in a tertiary-level hospital .
METHODS	We prospectively enrolled 58 patients with medial knee osteoarthritis and randomized them to use either a lateral wedge insole with subtalar strapping ( Group W ) , or a neutral insole with subtalar strapping ( Group N - control ) .
METHODS	All the patients were instructed to use the insole for five to ten hours per day .
METHODS	A visual analogue pain scale , the Western Ontario and McMaster Universities Arthritis Index ( WOMAC ) and the Lequesne questionnaire were applied at baseline and at weeks 2 , 8 and 24 .
RESULTS	At weeks 8 and 24 , both groups showed lower scores for WOMAC ( P = 0,023 and P = 0,012 respectively ) .
RESULTS	There were no statistically significant differences between the groups regarding the visual analogue pain scale , WOMAC or Lequesne results at any time evaluated .
CONCLUSIONS	The use of a lateral wedge insole with subtalar strapping improved the patients ' symptoms and function but was not superior to placebo insoles .

###24574507
BACKGROUND	The relation between the pattern of local anaesthetic ( LA ) spread and the quality of peripheral nerve block is unclear .
METHODS	Twenty-one volunteers were randomized to receive a median nerve block with intended circumferential or intended non-circumferential spread of LA. .
METHODS	Different predetermined volumes and needle placement techniques were used to produce the different patterns of LA spread .
METHODS	Volumetric , multiplanar 3D ultrasound imaging was performed to evaluate the pattern and extent of LA spread .
METHODS	Sensory block was assessed at predetermined intervals .
RESULTS	Complete circumferential spread of LA was achieved in only 67 % of cases in the intended circumferential study group and in 33 % of cases in the intended non-circumferential group .
RESULTS	Block success was similar ( 90 % ) and independent of whether circumferential or non-circumferential spread of the LA was achieved .
RESULTS	All block failures ( n = 4 ) occurred in the intended non-circumferential group with low volumes of LA. .
RESULTS	The onset of sensory block ( independent of group allocation ) was faster with circumferential spread of LA [ median ( IQR ) onset time , 15 ( 8 ; 20 ) min ] compared with non-circumferential spread of LA [ median ( IQR ) onset time , 20 ( 15 ; 30 ) min ] .
RESULTS	More LA was used for circumferential blocks [ median ( IQR ) volume of LA 2.8 ( 1.3 ; 3.6 ) vs 1.3 ( 1.1 ; 2.4 ) ml ] .
CONCLUSIONS	Even under optimal conditions , it was not possible to achieve circumferential spread of LA in all intended cases .
CONCLUSIONS	The success of median nerve block seems to be independent of the pattern of LA spread .
BACKGROUND	DRKS 00003826 .

###25015406
BACKGROUND	The demand for long-term care for older adults has escalated sharply .
BACKGROUND	A good policy dedicated to the welfare of older adults has improved their quality of life .
BACKGROUND	The purpose of this study was to explore the social welfare utilization and needs of older adults and compare their differences among age groups , genders , and functional dependency levels .
METHODS	Three hundred eighty-four stratified , random-sampled Taiwanese community-dwelling older adults were recruited for this survey research .
METHODS	Participants rated their utilization of and needs for the 30 social welfare services provided by the government on a Likert-type scale .
RESULTS	The most widely used and needed social welfare services by the older adults were senior monetary stipend and a subsidy for the national health insurance premium .
RESULTS	Young-old , male , and functionally independent older adults had more knowledge of the social welfare services than their counterparts .
CONCLUSIONS	While designing a comprehensive social welfare system , differing needs of different age groups , genders , and functional dependency levels should be taken into consideration .

###25561816
OBJECTIVE	To evaluate the differences in the treatment outcomes between the unresectable and recurrent biliary tract cancer patients who received chemotherapy .
METHODS	Patients who were treated with gemcitabine and S-1 combination therapy in the previous prospective studies were divided into groups of unresectable and recurrent cases .
METHODS	The tumor response , time-to-progression , overall survival , toxicity , and dose intensity were compared between these two groups .
RESULTS	Response rate of the recurrent group was higher than that of the unresectable group ( 40.0 % vs 25.5 % ; P = 0.34 ) .
RESULTS	Median time-to-progression of the recurrent and unresectable groups were 8.7 mo ( 95 % CI ) , 1.2 mo , not reached ) and 5.7 mo ( 95 % CI : 4.0-7 .0 mo ) , respectively ( P = 0.14 ) .
RESULTS	Median overall survival of the recurrent and the unresectable groups were 16.1 mo ( 95 % CI : 2.0 mo-not reached ) and 9.6 mo ( 95 % CI : 7.1-11 .7 mo ) , respectively ( P = 0.10 ) .
RESULTS	Dose intensities were significantly lower in the recurrent groups ( gemcitabine : recurrent group 83.5 % vs unresectable group 96.8 % ; P < 0.01 , S-1 : Recurrent group 75.9 % vs unresectable group 91.8 % ; P < 0.01 ) .
RESULTS	Neutropenia occurred more frequently in recurrent group ( recurrent group 90 % vs unresectable group 55 % ; P = 0.04 ) .
CONCLUSIONS	Not only the efficacy but also the toxicity and dose intensity were significantly different between unresectable and recurrent biliary tract cancer .

###24482348
OBJECTIVE	Steroid-eluting spacers can improve local drug delivery immediately following endoscopic sinus surgery and reduce the recurrence of inflammation warranting systemic corticosteroids .
OBJECTIVE	For chronic rhinosinusitis with nasal polyposis , the need for systemic corticosteroids immediately following endoscopic sinus surgery when using a steroid-eluting spacer has not been studied .
METHODS	A randomized , double-blind , placebo-controlled trial .
METHODS	Academic rhinology practice .
METHODS	Chronic rhinosinusitis patients with nasal polyposis who failed medical therapy and elected endoscopic sinus surgery were enrolled .
METHODS	Patients were randomized into either the treatment arm ( postoperative prednisone 30 mg daily 7 days ; n = 18 ) or placebo arm ( postoperative placebo pill daily 7 days ; n = 18 ) .
METHODS	Outcomes were evaluated at 1 week , 3 weeks , and 2 months postoperatively .
METHODS	Primary outcome was endoscopic grading at postoperative month 2 using the Lund-Kennedy system .
METHODS	Secondary outcome included disease-specific quality of life using the Sinonasal Outcome Test ( SNOT-22 ) survey .
METHODS	Patient enrollment occurred from January 2012 through February 2013 ( NCT01564355 ) .
RESULTS	Both arms received significant improvement in endoscopic grading and disease-specific quality of life from baseline compared to 2-month follow-up ( P < .001 ) .
RESULTS	There were no significant differences in mean endoscopic scores between the postoperative prednisone and control groups at 1 week ( P = .715 ) , 3 weeks ( P = .883 ) , or 2 months ( P = .343 ) .
RESULTS	There were no significant differences in SNOT-22 scores between groups at all follow-up points ( all P > .119 ) .
CONCLUSIONS	Minimizing systemic corticosteroid use in patients with chronic rhinosinusitis with nasal polyposis may avoid adverse events .
CONCLUSIONS	Results from this study suggest that postoperative systemic corticosteroids immediately following endoscopic sinus surgery may not provide improved outcomes when utilizing a steroid-eluting spacer .

###24834792
OBJECTIVE	To study the effects of lifestyle intervention in pregnancy on weight retention 6months postpartum among obese women from the `` Lifestyle in Pregnancy '' ( LiP ) study , and to determine associations between breastfeeding with postpartum maternal weight .
METHODS	Six months postpartum follow up after a randomized controlled intervention trial .
METHODS	Two university hospitals in Denmark .
METHODS	A total of 360 women with pregestational body mass index 30kg/m ( 2 ) .
METHODS	The intervention involved lifestyle changes ( diet and exercise ) during pregnancy .
METHODS	The control group received routine pregnancy care .
METHODS	Both groups received standard postnatal care .
METHODS	Gestational weight gain , postpartum weight retention and breastfeeding .
RESULTS	Follow up was completed in 238 women of whom 46 % in the intervention group and 57 % in the control group had retained weight 6months postpartum ( p = 0.088 ) .
RESULTS	Women with gestational weight gain 9kg , ( recommended by the Institute of Medicine ) , retained less postpartum weight compared with those who exceeded 9kg ( median -0.7 vs. 1.5 , p < 0.001 ) .
RESULTS	Ninety-two percent in both weight gain groups initiated breastfeeding .
RESULTS	The number of breastfeeding mothers was higher among women with postpartum weight retention 5kg compared with those with weight retention > 5kg ( 94 % vs. 85 % , p = 0.034 ) .
CONCLUSIONS	We could not detect sustained weight control at 6months postpartum despite a lower gestational weight gain for obese women during pregnancy who received a lifestyle intervention rather than standard care .
CONCLUSIONS	Women who adhered to gestational weight gain recommendations had significantly lower postpartum weight retention .
CONCLUSIONS	Breastfeeding for 6months was negatively associated with postpartum weight retention .

###24457911
BACKGROUND	The addition of trastuzumab ( T ) and lapatinib ( L ) to neoadjuvant chemotherapy increases the pathological complete response ( pCR ) rate in patients with human epidermal growth factor receptor 2 ( HER2 ) - positive early breast cancer .
BACKGROUND	We investigated the efficacy of T or L with neoadjuvant chemotherapy and specific efficacy biomarkers .
METHODS	Patients with stages I-III ( including inflammatory ) HER2-positive breast cancer were randomised to receive epirubicin ( E ) plus cyclophosphamide ( C ) 4 cycles followed by docetaxel ( D ) plus either T ( EC-DT ) or L ( EC-DL ) .
METHODS	End points included pCR ( primary ) , clinical response , toxicity , and pCR-predictive biomarkers .
RESULTS	We randomised 102 patients to EC-DT ( 50 ) and EC-DL ( 52 ) .
RESULTS	Median age was 48 , 56 % were premenopausal and 58 % had oestrogen receptor ( ER ) - positive tumours .
RESULTS	Pathological complete response in breast was 52.1 % ( 95 % CI :38.0 -66.2 % ) for EC-DT and 25.5 % ( 95 % CI :13.5 -37.5 % ) for EC-DL ( P = 0.0065 ) .
RESULTS	Pathological complete response in breast and axilla was 47.9 % for EC-DT and 23.5 % for EC-DL ( P = 0.011 ) .
RESULTS	Grade 3-4 toxicity did not differ across treatments , except for diarrhoea ( 2 % in EC-DT vs 13.5 % in EC-DL , P = 0.030 ) .
RESULTS	Multivariate analyses showed that treatment ( P = 0.036 ) and ER ( P = 0.014 ) were the only predictors of pCR in both groups .
CONCLUSIONS	EC-DT exhibited higher efficacy and lower toxicity than EC-DL .
CONCLUSIONS	Of the different biomarkers studied , only the absence of ER expression was associated with increased pCR .

###25961461
BACKGROUND	Individuals treated with the cholesteryl ester transfer protein ( CETP ) inhibitor anacetrapib exhibit a reduction in both LDL cholesterol and apolipoprotein B ( ApoB ) in response to monotherapy or combination therapy with a statin .
BACKGROUND	It is not clear how anacetrapib exerts these effects ; therefore , the goal of this study was to determine the kinetic mechanism responsible for the reduction in LDL and ApoB in response to anacetrapib .
METHODS	We performed a trial of the effects of anacetrapib on ApoB kinetics .
METHODS	Mildly hypercholesterolemic subjects were randomized to background treatment of either placebo ( n = 10 ) or 20 mg atorvastatin ( ATV ) ( n = 29 ) for 4 weeks .
METHODS	All subjects then added 100 mg anacetrapib to background treatment for 8 weeks .
METHODS	Following each study period , subjects underwent a metabolic study to determine the LDL-ApoB-100 and proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) production rate ( PR ) and fractional catabolic rate ( FCR ) .
RESULTS	Anacetrapib markedly reduced the LDL-ApoB-100 pool size ( PS ) in both the placebo and ATV groups .
RESULTS	These changes in PS resulted from substantial increases in LDL-ApoB-100 FCRs in both groups .
RESULTS	Anacetrapib had no effect on LDL-ApoB-100 PRs in either treatment group .
RESULTS	Moreover , there were no changes in the PCSK9 PS , FCR , or PR in either group .
RESULTS	Anacetrapib treatment was associated with considerable increases in the LDL triglyceride/cholesterol ratio and LDL size by NMR .
CONCLUSIONS	These data indicate that anacetrapib , given alone or in combination with a statin , reduces LDL-ApoB-100 levels by increasing the rate of ApoB-100 fractional clearance .
BACKGROUND	ClinicalTrials.gov NCT00990808 .
BACKGROUND	Merck & Co. .
BACKGROUND	Inc. , Kenilworth , New Jersey , USA .
BACKGROUND	Additional support for instrumentation was obtained from the National Center for Advancing Translational Sciences ( UL1TR000003 and UL1TR000040 ) .

###24888230
BACKGROUND	DISRUPT evaluated whether adding the vascular-disrupting agent ombrabulin to a taxane-platinum doublet in the first-line setting improved progression-free survival ( PFS ) in patients with metastatic non-small cell lung cancer ( NSCLC ) .
METHODS	Patients were randomised to ombrabulin 35 mg/m ( 2 ) or placebo followed by a taxane-platinum regimen every 3 weeks .
RESULTS	Overall , 176 patients were randomised .
RESULTS	After 124 events , median PFS was not significantly improved with ombrabulin vs placebo ( 5.65 vs 5.45 months ; HR 0.948 ; 60 % CI 0.813-1 .106 ; one-sided P = 0.39 ) .
RESULTS	The two groups showed similar overall survival ( median 11.0 months in both groups ) , objective response rate ( 32 % ombrabulin ; 31 % placebo ) and safety profiles .
CONCLUSIONS	This study did not meet its primary endpoint of improving PFS by adding ombrabulin to a taxane-platinum regimen for first-line treatment of metastatic NSCLC .

###24386975
OBJECTIVE	Outcome monitoring feedback has become popular , but its effect on treatment outcome has been mixed .
OBJECTIVE	Feedback seems most effective for patients who are not progressing well ( `` not on track '' ( NOT ) cases ) .
OBJECTIVE	There are some indications that patient feedback has an additional effect and that feedback effects differentiate between short - and long-term therapy .
OBJECTIVE	This study aimed to evaluate the effect of outcome monitoring feedback to therapists and patients on outcome in short - and long-term psychotherapy .
METHODS	Patients ( n = 475 ) were randomly assigned to three conditions : Feedback to therapist ( FbT ) , feedback to therapist and patient ( FbTP ) , and no feedback ( NFb ) .
METHODS	Feedback consisted of progress charts based on the Outcome Questionnaire and a feedback message .
RESULTS	In short-term therapies ( < 35 weeks ) FbT and FbTP was preventive of negative change for NOT cases .
RESULTS	In long-term therapy only FbTP had a small positive effect on the rate of change .
RESULTS	Feedback did not result in better outcomes at treatment ending , although there was a trend for FbTP to have fewer deteriorated cases .
CONCLUSIONS	Benefits of feedback were strongest for cases that were not progressing well in short-term therapies when both the patient and therapist received feedback on the patients ' progress .
CONCLUSIONS	Contrary to previous findings , we also found a small effect of feedback to therapists and patients in long-term therapies .
CONCLUSIONS	Feedback to both patients and therapists may be more effective than feedback to therapists alone due to implementation issues or empowerment of the patient .

###24418597
BACKGROUND	Australian Aboriginal and Torres Strait Islander peoples ( Indigenous Australians ) smoke at much higher rates than non-Indigenous people and smoking is an important contributor to increased disease , hospital admissions and deaths in Indigenous Australian populations .
BACKGROUND	Smoking cessation programs in Australia have not had the same impact on Indigenous smokers as on non-Indigenous smokers .
BACKGROUND	This paper describes the outcome of a study that aimed to test the efficacy of a locally-tailored , intensive , multidimensional smoking cessation program .
METHODS	A randomised controlled trial of Aboriginal researcher delivered tailored smoking cessation counselling during face-to-face visits , aiming for weekly for the first four weeks , monthly to six months and two monthly to 12 months .
METHODS	The control ( `` usual care '' ) group received routine care relating to smoking cessation at their local primary health care service .
METHODS	Data collection occurred at enrolment , six and 12 months .
METHODS	The primary outcome was self-reported smoking cessation with urinary cotinine confirmation at final follow-up ( median 13 ( interquartile range 12-15 ) months after enrolment ) .
RESULTS	Participants in the intervention ( n = 55 ) and usual care ( n = 108 ) groups were similar in baseline characteristics , except the intervention group was slightly older .
RESULTS	At final follow-up the smoking cessation rate for participants assigned to the intervention group ( n = 6 ; 11 % ) , while not statistically significant , was double that of usual care ( n = 5 ; 5 % ; p = 0.131 ) .
RESULTS	A meta-analysis of these findings and a similarly underpowered but comparable study of pregnant Indigenous Australian women showed that Indigenous Australian participants assigned to the intervention groups were 2.4 times ( 95 % CI , 1.01-5 .5 ) as likely to quit as participants assigned to usual care .
CONCLUSIONS	Culturally appropriate , multi-dimensional Indigenous quit smoking programs can be successfully implemented in remote primary health care .
CONCLUSIONS	Intensive one-on-one interventions with substantial involvement from Aboriginal and Torres Strait Islander workers are likely to be effective in these settings .
BACKGROUND	Australian New Zealand Clinical Trials Registry ( ACTRN12608000604303 ) .

###24355669
BACKGROUND	Desk-based office employees sit for most of their working day .
BACKGROUND	To address excessive sitting as a newly identified health risk , best practice frameworks suggest a multi-component approach .
BACKGROUND	However , these approaches are resource intensive and knowledge about their impact is limited .
OBJECTIVE	To compare the efficacy of a multi-component intervention to reduce workplace sitting time , to a height-adjustable workstations-only intervention , and to a comparison group ( usual practice ) .
METHODS	Three-arm quasi-randomized controlled trial in three separate administrative units of the University of Queensland , Brisbane , Australia .
METHODS	Data were collected between January and June 2012 and analyzed the same year .
METHODS	Desk-based office workers aged 20-65 ( multi-component intervention , n = 16 ; workstations-only , n = 14 ; comparison , n = 14 ) .
METHODS	The multi-component intervention comprised installation of height-adjustable workstations and organizational-level ( management consultation , staff education , manager e-mails to staff ) and individual-level ( face-to-face coaching , telephone support ) elements .
METHODS	Workplace sitting time ( minutes/8-hour workday ) assessed objectively via activPAL3 devices worn for 7 days at baseline and 3 months ( end-of-intervention ) .
RESULTS	At baseline , the mean proportion of workplace sitting time was approximately 77 % across all groups ( multi-component group 366 minutes/8 hours [ SD = 49 ] ; workstations-only group 373 minutes/8 hours [ SD = 36 ] , comparison 365 minutes/8 hours [ SD = 54 ] ) .
RESULTS	Following intervention and relative to the comparison group , workplace sitting time in the multi-component group was reduced by 89 minutes/8-hour workday ( 95 % CI = -130 , -47 minutes ; p < 0.001 ) and 33 minutes in the workstations-only group ( 95 % CI = -74 , 7 minutes , p = 0.285 ) .
CONCLUSIONS	A multi-component intervention was successful in reducing workplace sitting .
CONCLUSIONS	These findings may have important practical and financial implications for workplaces targeting sitting time reductions .
BACKGROUND	Australian New Zealand Clinical Trials Registry 00363297 .

###24947045
BACKGROUND	Obesity is a pressing public health concern , which frequently presents in primary care .
BACKGROUND	With the explosive obesity epidemic , there is an urgent need to maximize effective management in primary care .
BACKGROUND	The 5As of Obesity Management ( 5As ) are a collection of knowledge tools developed by the Canadian Obesity Network .
BACKGROUND	Low rates of obesity management visits in primary care suggest provider behaviour may be an important variable .
BACKGROUND	The goal of the present study is to increase frequency and quality of obesity management in primary care using the 5As Team ( 5AsT ) intervention to change provider behaviour .
METHODS	The 5AsT trial is a theoretically informed , pragmatic randomized controlled trial with mixed methods evaluation .
METHODS	Clinic-based multidisciplinary teams ( RN/NP , mental health , dietitians ) will be randomized to control or the 5AsT intervention group , to participate in biweekly learning collaborative sessions supported by internal and external practice facilitation .
METHODS	The learning collaborative content addresses provider-identified barriers to effective obesity management in primary care .
METHODS	Evidence-based shared decision making tools will be co-developed and iteratively tested by practitioners .
METHODS	Evaluation will be informed by the RE-AIM framework .
METHODS	The primary outcome measure , to which participants are blinded , is number of weight management visits/full-time equivalent ( FTE ) position .
METHODS	Patient-level outcomes will also be assessed , through a longitudinal cohort study of patients from randomized practices .
METHODS	Patient outcomes include clinical ( e.g. , body mass index [ BMI ] , blood pressure ) , health-related quality of life ( SF-12 , EQ5D ) , and satisfaction with care .
METHODS	Qualitative data collected from providers and patients will be evaluated using thematic analysis to understand the context , implementation and effectiveness of the 5AsT program .
CONCLUSIONS	The 5AsT trial will provide a wide range of insights into current practices , knowledge gaps and barriers that limit obesity management in primary practice .
CONCLUSIONS	The use of existing resources , collaborative design , practice facilitation , and integrated feedback loops cultivate an applicable , adaptable and sustainable approach to increasing the quantity and quality of weight management visits in primary care .
BACKGROUND	NCT01967797 .

###24876771
OBJECTIVE	Both exercise and self-management are advocated in pulmonary rehabilitation for people with chronic obstructive pulmonary disease ( COPD ) .
OBJECTIVE	The widely used 6-week , group-based Chronic Disease Self-Management Program ( CDSMP ) increases self-reported exercise , despite supervised exercise not being a program component .
OBJECTIVE	This has been little explored in COPD .
OBJECTIVE	Whether adding supervised exercise to the CDSMP would add benefit is unknown .
OBJECTIVE	We investigated the CDSMP in COPD , with and without a formal supervised exercise component , to address this question .
METHODS	Adult outpatients with COPD were randomized to the CDSMP with or without one hour of weekly supervised exercise over 6 weeks .
METHODS	The primary outcome measure was 6-minute walk test distance ( 6MWD ) .
METHODS	Secondary outcomes included self-reported exercise , exercise stage of change , exercise self-efficacy , breathlessness , quality of life , and self-management behaviors .
METHODS	Within - and between-group differences were analyzed on an intention-to-treat basis .
RESULTS	Of 84 subjects recruited , 15 withdrew .
RESULTS	6MWD increased similarly in both groups : CDSMP-plus-exercise ( intervention group ) by 18.646.2 m ; CDSMP-alone ( control group ) by 20.046.2 m.
RESULTS	There was no significant difference for any secondary outcome .
CONCLUSIONS	The CDSMP produced small statistically significant increase in 6MWD .
CONCLUSIONS	The addition of a single supervised exercise session did not further increase exercise capacity .
CONCLUSIONS	Our findings confirm the efficacy of a behaviorally based intervention in COPD , but this would seem to be less than expected from conventional exercise-based pulmonary rehabilitation , raising the question of how , if at all , the small gains observed in this study may be augmented .

###24890483
OBJECTIVE	To assess the effectiveness of a habit-based intervention delivered by e-mail or sms in improving fruit and vegetable consumption among young adults .
METHODS	An eight-week randomised controlled trial compared the effectiveness of three different types of message content ( habit-based messages ; food-group messages ; general healthy eating messages ) and two delivery methods ( e-mail versus sms ) on habit strength and consumption of fruits and vegetables in 71 undergraduate participants .
RESULTS	A significant message content by time interaction indicated that the habit-based intervention improved fruit consumption over the eight-week period .
RESULTS	Vegetable consumption significantly increased over the intervention period regardless of message content .
RESULTS	Delivery method did not influence these results .
CONCLUSIONS	Messages based on a habit framework can be utilised to improve fruit consumption in young adults .
CONCLUSIONS	Furthermore , simply reminding young adults to be conscious of their food choices may be sufficient to improve their overall vegetable consumption .

###24527531
OBJECTIVE	To evaluate the safety and efficacy of tadalafil on demand and on time in men with erectile dysfunction .
METHODS	We conducted a multi-centered randomized controlled study on 120 ED males , who were assigned to take tadalafil at 10 mg / 20 mg on demand before sexual activity and at the same dose on time twice a week for 8 weeks .
METHODS	Before and at 4 and 8 weeks after treatment , and 1 month after withdrawal , we obtained the scores on IIEF-5 , ED Inventory of Treatment Satisfaction ( EDITS ) and the short form of Psychological and Interpersonal Relationship Scales ( SF-PAIRS ) , and compared the safety and efficacy of medication between the two groups of patients .
RESULTS	Totally , 110 patients accomplished the trial , 56 in the on-time and 54 in the on-demand group .
RESULTS	At 4 and 8 weeks of medication and 1 month after withdrawal , the IIEF-5 scores were improved in both the on-time and on-demand groups , even more significantly in the former than in the latter at 8 weeks of treatment ( 21.6 + / - 2.9 vs 18.5 + / - 1.7 ) and 1 month after withdrawal ( 20.9 + / - 2.1 vs 17.9 + / - 2.3 ) ( P < 0.05 ) .
RESULTS	The EDITS scores were significantly higher in the on-time than in the on-demand group at 8 weeks of treatment ( 31.7 + / - 6.9 vs 28.6 + / - 5.8 ) and 1 month after withdrawal ( 30.6 + / - 4.7 vs 27.9 + / - 6.5 ) ( P < 0.05 ) .
RESULTS	The scores on the sexual self-confidence , spontaneity and time-concern domains of SF-PAIRS were remarkably improved after medication as compared with the baseline ( P < 0.05 ) , even more significantly in the on-time than in the on-demand group at 1 month after withdrawal .
RESULTS	Both dosing schedules were well tolerated and no significant differences were observed in safety between the two groups .
CONCLUSIONS	On-time dosing of tadalafil is efficacious and well tolerated in the treatment of ED , and has an even better effect than on-demand dosing at 8 weeks of medication and 1 month after withdrawal .

###25432449
OBJECTIVE	Lasers have been extensively used in dentistry for several applications .
OBJECTIVE	We investigated and compared the use of an erbium : yttrium-aluminum-garnet laser and conventional rotary instruments for bone removal in third molar surgery .
METHODS	We implemented a randomized , split-mouth clinical trial .
METHODS	Patients with bilateral and symmetrical third molar impaction referred to the Department of Oral and Maxillo-Facial Sciences , `` Sapienza '' University of Rome , were enrolled in the study .
METHODS	Each patient was treated once with the erbium : yttrium-aluminum-garnet laser and once with conventional rotary instruments for bone removal during third molar surgery .
METHODS	Pain , swelling , and trismus were taken into account to match the 2 techniques.In addition , the times required to complete osteotomy and for the full operation were recorded .
METHODS	Descriptive and bivariate statistics were computed , and the P value was set at .05 .
RESULTS	The sample was composed of 15 patients ( 8 men and 7 women ) ranging in age from 18 to 30 years .
RESULTS	Pain perceived in the laser-treated group was significantly less than that in the conventional group ( P = .0013 ) .
RESULTS	This also was true for trismus ( P = .0002 ) and swelling .
RESULTS	The operating time for osteotomy was longer in the laser group .
CONCLUSIONS	The results of this study suggest that the laser could be an interesting alternative to conventional rotary instruments .
CONCLUSIONS	Future studies with a larger number of patients are required to confirm the conclusions achieved from this work .

###25348013
BACKGROUND	Home care workers are a high-risk group for injury and illness .
BACKGROUND	Their unique work structure presents challenges to delivering a program to enhance their health and safety .
BACKGROUND	No randomized controlled trials have assessed the impact of a Total Worker Health program designed for their needs .
METHODS	The COMPASS ( COMmunity of Practice And Safety Support ) study is a cluster randomized trial being implemented among Oregon 's unionized home care workers .
METHODS	Partnering with the Oregon Home Care Commission allowed recruiting 10 pairs of home care worker groups with 8 participants per group ( n = 160 ) for balanced randomization of groups to intervention and control conditions .
METHODS	Physiologic and survey evaluation of all participants will be at enrollment , 6 months and 12 months .
METHODS	Primary outcomes are to increase health promoting ( for example , healthy nutrition and regular physical activity ) and health protecting ( that is , safety ) behaviors .
METHODS	In addition to assessing outcomes adjusted for the hierarchical design , mediation analyses will be used to deconstruct and confirm the program 's theoretical underpinnings and intervention processes .
METHODS	Intervention groups will participate in a series of monthly 2-hour meetings designed as ritualized , scripted peer-led sessions to increase knowledge , practice skills and build support for healthy actions .
METHODS	Self-monitoring and individual and team level goals are included to augment change .
METHODS	Because generalizability , reach and achieving dissemination are priorities , following initial wave findings , a second wave of COMPASS groups will be recruited and enrolled with tailoring of the program to align with existing Home Care Commission educational offerings .
METHODS	Outcomes , process and mediation of those tailored groups will be compared with the original wave 's findings .
CONCLUSIONS	The COMPASS trial will assess a novel program to enhance the safety and health of a vulnerable , rapidly expanding group of isolated caregivers , whose critical work allows independent living of frail seniors and the disabled .
BACKGROUND	ClinicalTrials.gov identifier : NCT02113371 , first registered 11 March 2014 .

###25008546
BACKGROUND	Many patients with Parkinson 's disease have motor fluctuations despite treatment with available drugs .
BACKGROUND	Tozadenant ( SYN115 ) is an oral , selective adenosine A2A receptor antagonist that improves motor function in animal models of Parkinson 's disease .
BACKGROUND	We aimed to assess the safety and efficacy of tozadenant as an adjunct to levodopa in patients with Parkinson 's disease who have motor fluctuations on levodopa .
METHODS	We did an international , multicentre , phase 2b , randomised , double-blind , placebo-controlled , parallel-group , dose-finding clinical trial of tozadenant in levodopa-treated patients with Parkinson 's disease who had motor fluctuations ( at least 25 h off-time per day ) .
METHODS	Eligible patients were randomly assigned via a computer-generated randomisation schedule to receive tozadenant 60 , 120 , 180 , or 240 mg or matching placebo twice daily for 12 weeks .
METHODS	All study management , site personnel , and patients were masked to treatment assignment .
METHODS	The primary outcome was change from baseline to week 12 in hours per day spent in the off-state ( assessed from Parkinson 's disease diaries completed by patients ) .
METHODS	This study is registered at ClinicalTrials.gov , number NCT01283594 .
RESULTS	Of 420 randomised patients ( mean age 633 [ SD 83 ] years ; mean duration of Parkinson 's disease 87 [ 47 ] years ) , 403 provided post-baseline diary data and 337 completed study treatment .
RESULTS	Compared with placebo , mean daily off-time was significantly reduced in the combined tozadenant 120 mg twice-daily and 180 mg twice-daily group ( -11 h , 95 % CI -18 to -05 ; p = 00006 ) , the tozadenant 120 mg twice-daily group ( -11 h , -18 to -04 ; p = 0.0039 ) , and the tozadenant 180 mg twice-daily group ( -12 h , -19 to -04 ; p = 00039 ) .
RESULTS	The most common adverse events in these groups were dyskinesia ( seven [ 8 % ] of 84 patients in the placebo group , 13 [ 16 % ] of 82 in the 120 mg twice-daily group , and 17 [ 20 % ] of 85 in the 180 mg twice-daily group ) , nausea ( three [ 4 % ] , 9 [ 11 % ] , and ten [ 12 % ] ) , and dizziness ( one [ 1 % ] , four [ 5 % ] , and 11 [ 13 % ] ) .
RESULTS	Tozadenant 60 mg twice daily was not associated with a significant reduction in off-time , and tozadenant 240 mg twice daily was associated with an increased rate of discontinuation because of adverse events ( 17 [ 20 % ] of 84 patients ) .
CONCLUSIONS	Tozadenant at 120 or 180 mg twice daily was generally well tolerated and was effective at reducing off-time .
CONCLUSIONS	Further investigation of tozadenant treatment in phase 3 trials is warranted .
BACKGROUND	Biotie Therapies .

###24795094
OBJECTIVE	To assess the effects of the RHANI ( Reducing HIV among Non-Infected ) Wives intervention on marital conflict and intimate partner violence ( IPV ) in urban India .
METHODS	A 2-armed cluster-randomized controlled trial ( 7 intervention , 6 control clusters ) of the RHANI Wives intervention was conducted with 220 women contending with a history of IPV and/or husband 's drunken behavior .
METHODS	Participants were surveyed at baseline and 4.5-month follow-up .
METHODS	Outcome measures included marital conflict ( arguments with husband in past 3 months ) , marital IPV ( physical or sexual violence from husband in past 3 months ) , and marital sexual coercion ( husband forcing sex at last sex ) .
METHODS	Intention-to-treat logistic generalized linear mixed models were used to determine intervention impact .
RESULTS	One-third ( 35.0 % ) of participants reported physical or sexual abuse from their husband in the past 3 months , and 58.6 % reported that their husband was drunk in the past 30 days .
RESULTS	Intention-to-treat analyses indicated timetreatment reductions in marital conflict ( risk ratio [ RR ] 0.4 ; 90 % confidence interval [ CI ] , 0.1-0 .9 ; P = 0.06 ) and marital sexual coercion ( RR 0.2 ; 90 % CI , 0.05-0 .9 ; P = 0.08 ) , but not IPV .
CONCLUSIONS	The findings suggest the potential utility of this intervention in reducing marital conflict and sexual coercion among women in urban India .
CONCLUSIONS	ClinicalTrials.gov : NCT01592994 .

###24812304
BACKGROUND	Mineralocorticoid receptor antagonists reduce morbidity and mortality in patients with heart failure but can cause hyperkalemia , which contributes to reduced use of these drugs .
BACKGROUND	Hypokalemia also leads to worse outcomes in patients with heart failure and may be attenuated by mineralocorticoid receptor antagonists .
RESULTS	We assessed incidence and predictors of hyperkalemia ( potassium 5.5 mmol/L ) and hypokalemia ( potassium < 3.5 mmol/L ) and the relationship to outcomes in 1663 patients with class III or IV heart failure and left ventricular ejection fraction < 35 % randomized to treatment with spironolactone 25 mg or placebo in the Randomized Aldactone Evaluation Study ( RALES ) trial .
RESULTS	All-cause mortality rates and the influence of potassium levels on the effectiveness of spironolactone were assessed in a landmark analysis and in relation to time-varying potassium levels .
RESULTS	After 1 month , mean potassium levels increased in the spironolactone group but not in the placebo group ( 4.540.49 versus 4.280.50 mmol/L ; P < 0.001 ) and remained elevated during the trial .
RESULTS	Although the extremes of hypokalemia and hyperkalemia at 4 weeks were associated with increased risk of mortality in both treatment arms , participants in the spironolactone arm had lower mortality rates at all potassium levels throughout the duration of the trial .
RESULTS	The treatment benefit of spironolactone was maintained at least until potassium exceeded 5.5 mmol/L .
CONCLUSIONS	With appropriate surveillance of potassium and creatinine , the use of spironolactone was associated with less hypokalemia and improved survival in patients with severe heart failure even in the setting of moderate hyperkalemia .

###24828091
OBJECTIVE	To investigate the effects of a multifaceted implementation strategy on behaviour , behavioural determinants , knowledge and awareness of healthcare workers regarding the use of recommendations to prevent hand eczema .
METHODS	The Hands4U study is a randomised controlled trial .
METHODS	A total of 48 departments ( n = 1649 workers ) were randomly allocated to the multifaceted implementation strategy or the control group ( minimal implementation strategy ) .
METHODS	Within the departments designated to the multifaceted implementation strategy , participatory working groups were set up to enhance the implementation of the recommendations for hand eczema .
METHODS	In addition , working group members were trained to become role models , and an education session was given within the department .
METHODS	Outcome measures were awareness , knowledge , receiving information , behaviour and behavioural determinants .
METHODS	Data were collected at baseline , with a 3 - and 6-month follow-up .
RESULTS	Statistically significant effects were found after 6months for awareness ( OR 6.30 ; 95 % CI 3.41 to 11.63 ) , knowledge ( B 0.74 ; 95 % CI 0.54 to 0.95 ) , receiving information ( OR 9.81 ; 95 % CI 5.60 to 17.18 ) , washing hands ( B -0.40 ; 95 % -0.51 to -0.29 ) , use of moisturiser ( B 0.29 ; 95 % CI 0.20 to 0.38 ) , cotton under gloves ( OR 3.94 ; 95 % CI 2.04 to 7.60 ) and the overall compliance measure ( B 0.14 ; 95 % CI 0.02 to 0.26 ) , as a result of the multifaceted implementation strategy .
RESULTS	No effects were found for behavioural determinants .
CONCLUSIONS	The multifaceted implementation strategy can be used in healthcare settings to enhance the implementation of recommendations for the prevention of hand eczema .
BACKGROUND	NTR2812 .

###25175269
OBJECTIVE	To examine the effects of pretreatment with diquafosol 3.0 % ophthalmic solution on corneal surface wetting during cataract surgery with intraocular lens ( IOL ) implantation in cases of senile cataract .
METHODS	Shohzankai Medical Foundation , Miyake Eye Hospital , Nagoya , Japan .
METHODS	Prospective randomized single-masked comparative study .
METHODS	Phacoemulsification and IOL implantation were performed in eyes with senile cataract .
METHODS	After a 2-week washout period , patients were randomly assigned to receive 1 drop of diquafosol 3.0 % ophthalmic solution or artificial tears 6 times daily for 4 weeks before surgery .
METHODS	The main outcome measure , termed the corneal wetting property , was the time between when a clear image of the operating microscope light source appeared just after the corneal surface was irrigated with a balanced salt solution and the time at which that image began to blur .
RESULTS	The study enrolled 51 patients ( 76 eyes ) .
RESULTS	The mean time to corneal wetting was 50.1 seconds 10.8 ( SD ) in the diquafosol group and 45.3 9.2 seconds in the artificial tears group .
RESULTS	The difference between the 2 groups was statistically significant ( P < .029 ) .
CONCLUSIONS	Four-week pretreatment with diquafosol 3.0 % ophthalmic solution in patients with senile cataract scheduled for cataract surgery with IOL implantation was effective in enhancing the intraoperative corneal surface wetting property , which suggests improved optical clarity during surgery .
BACKGROUND	No author has a financial or proprietary interest in any material or method mentioned .

###25087600
OBJECTIVE	This randomised , double-blind , 12-week study compared efficacy and tolerability of flexible-dose treatment with vortioxetine ( 10-20 mg/day ) versus agomelatine ( 25-50 mg/day ) in major depressive disorder patients with inadequate response to selective serotonin reuptake inhibitor ( SSRI ) / serotonin-noradrenaline reuptake inhibitor ( SNRI ) monotherapy .
METHODS	Patients were switched directly from SSRI/SNRI to vortioxetine or agomelatine .
METHODS	Primary endpoint was change from baseline to week 8 in the Montgomery-sberg Depression Rating Scale ( MADRS ) total score analysed by mixed model for repeated measurements , using a noninferiority test followed by a superiority test .
METHODS	Secondary endpoints included response and remission rates , anxiety symptoms ( Hamilton Anxiety Rating Scale ) , Clinical Global Impression , overall functioning ( Sheehan Disability Scale ) , health-related quality of life ( EuroQol 5 Dimensions ) , productivity ( work limitation questionnaire ) and family functioning ( Depression and Family Functioning Scale ) .
RESULTS	Primary endpoint noninferiority was established and vortioxetine ( n = 252 ) was superior to agomelatine ( n = 241 ) by 2.2 MADRS points ( p < 0.01 ) .
RESULTS	Vortioxetine was also significantly superior in response and remission rates at weeks 8 and 12 ; MADRS , Hamilton Anxiety Rating Scale , Clinical Global Impression , Sheehan Disability Scale and EuroQol 5 Dimensions scores at week 4 onwards ; work limitation questionnaire at week 8 and Depression and Family Functioning Scale at weeks 8 and 12 .
RESULTS	Fewer patients withdrew because of adverse events with vortioxetine ( 5.9 % vs 9.5 % ) .
RESULTS	Adverse events ( incidence 5 % ) were nausea , headache , dizziness and somnolence .
CONCLUSIONS	Vortioxetine was noninferior and significantly superior to agomelatine in major depressive disorder patients with previous inadequate response to a single course of SSRI/SNRI monotherapy .
CONCLUSIONS	Vortioxetine was safe and well tolerated .

###25752972
BACKGROUND	Women with breast cancer experience different symptoms related to surgical or adjuvant therapy .
BACKGROUND	Previous findings and theoretical models of mind-body interactions suggest that psychological wellbeing , i.e. levels of distress , influence the subjective evaluation of symptoms , which influences or determines functioning .
BACKGROUND	The eight-week mindfulness-based stress reduction ( MBSR ) program significantly reduced anxiety and depression in breast cancer patients in a randomized controlled trial ( NCT00990977 ) .
BACKGROUND	In this study we tested the effect of MBSR on the burden of breast cancer related somatic symptoms , distress , mindfulness and spiritual wellbeing and evaluated possible effect modification by adjuvant therapy and baseline levels of , distress , mindfulness and spiritual wellbeing .
METHODS	A population-based sample of 336 women Danish women operated for breast cancer stages I-III were randomized to MBSR or usual care and were followed up for somatic symptoms , distress , mindfulness skills and spiritual wellbeing post-intervention and after six and 12 months .
METHODS	Effect was tested by general linear regression models post-intervention , and after six and 12 months follow-up and by mixed effects models for repeated measures of continuous outcomes .
METHODS	Effect size ( Cohen 's d ) was calculated to explore clinical significance of effects among intervention group .
METHODS	Finally , modification of effect of MBSR on burden of somatic symptoms after 12 months ' follow-up by adjuvant therapy and baseline levels of , distress , mindfulness and spiritual wellbeing were estimated .
RESULTS	General linear regression showed a significant effect of MBSR on the burden of somatic symptoms post-intervention and after 6 months ' follow-up .
RESULTS	After 12 months ' follow-up , no significant effect of MBSR on the burden of somatic symptoms was found in mixed effect models .
RESULTS	A statistically significant effect of MBSR on distress was found at all time-points and in the mixed effect models .
RESULTS	Significant effects on mindfulness were seen after six and 12 months and no significant effect was observed for spiritual wellbeing .
RESULTS	No significant modification of MBSR effect on somatic symptom burden was identified .
CONCLUSIONS	This first report from a randomized clinical trial on the long-term effect of MBSR finds an effect on somatic symptom burden related to breast cancer after six but not 12 months follow-up providing support for MBSR in this patient group .

###24907225
BACKGROUND	Although the addition of the HCV NS3/4A protease inhibitors boceprevir and telaprevir to pegylated interferon ( peginterferon ) alfa plus ribavirin has improved sustained virological response ( SVR ) in treatment-naive and treatment-experienced patients infected with hepatitis C virus ( HCV ) genotype 1 , the regimens have a high pill burden and are associated with increased rates and severity of adverse events , such as anaemia and rash .
BACKGROUND	The efficacy and safety of the combination of simeprevir , a one pill , once-daily , oral HCV NS3/4A protease inhibitor , plus peginterferon alfa 2a plus ribavirin were assessed in treatment-naive patients with HCV genotype 1 infection .
METHODS	In QUEST-1 , a phase 3 , randomised , double-blind multicentre trial undertaken in 13 countries ( Australia , Europe , North America , Puerto Rico , and New Zealand ) , 394 patients ( aged 18 years ) with chronic HCV genotype 1 infection and no history of HCV treatment , stratified by HCV subtype and host IL28B genotype , were randomly assigned in a 2:1 ratio with a computer-generated allocation sequence to receive simeprevir ( 150 mg once daily , orally ) plus peginterferon alfa 2a plus ribavirin for 12 weeks , followed by peginterferon alfa 2a plus ribavirin ( simeprevir group ) , or placebo orally plus peginterferon alfa 2a plus ribavirin for 12 weeks , followed by peginterferon alfa 2a plus ribavirin ( placebo group ) .
METHODS	Treatment duration was 24 weeks or 48 weeks in the simeprevir group according to criteria for response-guided therapy ( ie , HCV RNA < 25 IU/mL [ undetectable or detectable ] at week 4 and < 25 IU/mL undetectable at week 12 ) and 48 weeks in the placebo group .
METHODS	Patients , study personnel , and the sponsor were masked to the treatment group assignment .
METHODS	The primary efficacy endpoint was sustained virological response 12 weeks after the planned end of treatment ( SVR12 ) and was assessed with an intention-to-treat analysis .
METHODS	The results of the primary analysis ( week 60 ) are presented for safety and SVR12 .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01289782 .
RESULTS	Treatment with simeprevir , peginterferon alfa 2a , and ribavirin was superior to placebo , peginterferon alfa 2a , and ribavirin ( SVR12 in 210 [ 80 % ] patients of 264 vs 65 [ 50 % ] of 130 , respectively , adjusted difference 293 % [ 95 % CI 201-386 ; p < 00001 ) .
RESULTS	Adverse events in the first 12 weeks of treatment led to discontinuation of simeprevir in two ( < 1 % ) patients and discontinuation of placebo in one patient ( < 1 % ) ; fatigue ( 106 [ 40 % ] vs 49 [ 38 % ] patients , respectively ) and headache ( 81 [ 31 % ] vs 48 [ 37 % ] , respectively ) were the most common adverse events .
RESULTS	The prevalences of anaemia ( 42 [ 16 % ] vs 14 [ 11 % ] , respectively ) and rash ( 72 [ 27 % ] vs 33 [ 25 % ] ) were similar in the simeprevir and placebo groups .
RESULTS	Addition of simeprevir did not increase severity of patient-reported fatigue and functioning limitations , but shortened their duration .
CONCLUSIONS	Simeprevir once daily with peginterferon alfa 2a and ribavirin shortens therapy in treatment-naive patients with HCV genotype 1 infection without worsening the adverse event profiles associated with peginterferon alfa 2a plus ribavirin .
BACKGROUND	Janssen Infectious Diseases-Diagnostics .

###25111109
BACKGROUND	Depression , anxiety , and fatigue are among the most significant problems that influence the quality of life of patients with breast cancer who receive adjuvant chemotherapy .
BACKGROUND	Although evidence has shown yoga to decrease anxiety , depression , and fatigue in patients with cancer , few studies on the effects of yoga have targeted patients with breast cancer .
BACKGROUND	Yoga interventions should be tested to promote the psychological and physical health of women with breast cancer .
OBJECTIVE	This study examines the effectiveness of an 8-week yoga exercise program in promoting the psychological and physical health of women with breast cancer undergoing adjuvant chemotherapy in terms of depression , anxiety , and fatigue .
METHODS	A sample of 60 women with nonmetastatic breast cancer was recruited .
METHODS	Participants were randomly assigned into either the experimental group ( n = 30 ) or the control group ( n = 30 ) .
METHODS	A 60-minute , twice-per-week yoga exercise was implemented for 8 weeks as the intervention for the participants in the experimental group .
METHODS	The control group received standard care only .
RESULTS	Analysis using the Johnson-Neyman procedure found that the yoga exercise reduced overall fatigue and the interference of fatigue in everyday life for the experimental group participants .
RESULTS	Significant reductions were obtained after 4 weeks of intervention participation for those experimental group patients with relatively low starting baseline values ( baseline item mean value < 3.31 and 3.22 , respectively ) and after 8 weeks for most patients ( approximately 75 % ) with moderate starting baseline values ( baseline item mean value < 7.30 and 5.34 , respectively ) .
RESULTS	The 8-week intervention did not significantly improve the levels of depression ( F = 1.29 , p > .05 ) or anxiety ( F = 2.7 , p > .05 ) .
CONCLUSIONS	The 8-week yoga exercise program developed in this study effectively reduced fatigue in patients with breast cancer but did not reduce depression or anxiety .
CONCLUSIONS	Oncology nurses should strengthen their clinical health education and apply yoga to reduce the fatigue experienced by patients with breast cancer who undergo adjuvant chemotherapy .

###25250626
OBJECTIVE	Different types of carbohydrates have diverse glycemic response , thus glycemic index ( GI ) and glycemic load ( GL ) are used to assess this variation .
OBJECTIVE	The impact of dietary GI and GL in all-cause mortality is unknown .
OBJECTIVE	The objective of this study was to estimate the association between dietary GI and GL and risk of all-cause mortality in the PREDIMED study .
METHODS	The PREDIMED study is a randomized nutritional intervention trial for primary cardiovascular prevention based on community-dwelling men and women at high risk of cardiovascular disease .
METHODS	Dietary information was collected at baseline and yearly using a validated 137-item food frequency questionnaire ( FFQ ) .
METHODS	We assigned GI values of each item by a 5-step methodology , using the International Tables of GI and GL Values .
METHODS	Deaths were ascertained through contact with families and general practitioners , review of medical records and consultation of the National Death Index .
METHODS	Cox regression models were used to estimate multivariable-adjusted hazard ratios ( HR ) and their 95 % CI for mortality , according to quartiles of energy-adjusted dietary GI/GL .
METHODS	To assess repeated measures of exposure , we updated GI and GL intakes from the yearly FFQs and used Cox models with time-dependent exposures .
RESULTS	We followed 3,583 non-diabetic subjects ( 4.7 years of follow-up , 123 deaths ) .
RESULTS	As compared to participants in the lowest quartile of baseline dietary GI , those in the highest quartile showed an increased risk of all-cause mortality [ HR = 2.15 ( 95 % CI : 1.15-4 .04 ) ; P for trend = 0.012 ] .
RESULTS	In the repeated-measures analyses using as exposure the yearly updated information on GI , we observed a similar association .
RESULTS	Dietary GL was associated with all-cause mortality only when subjects were younger than 75 years .
CONCLUSIONS	High dietary GI was positively associated with all-cause mortality in elderly population at high cardiovascular risk .

###24859356
BACKGROUND	The aim of this study was to investigate the safety and efficacy of dalteparin during an elective percutaneous coronary intervention ( PCI ) procedure in a large cohort .
METHODS	In this prospective , randomized , open-label design study , 733 patients undergoing elective PCI were divided into an unfractionated heparin group ( group 1 , 323 patients ) or a dalteparin group ( group 2 , 410 patients ) .
METHODS	Blood samples were collected before and 18-24 h after the PCI procedure to determine the serum levels of cardiac troponin I ( cTnI ) and creatine kinase isoenzyme MB .
METHODS	Major adverse cardiac events ( MACEs ) and bleeding events during hospitalization were also recorded .
METHODS	Patients with an increased level of serum cTnI before PCI were excluded from the study .
RESULTS	After PCI , the cTnI values were greater than three times the upper limit of normal in 43 cases ( 13.3 % ) in group 1 and 52 cases ( 12.7 % ) in group 2 , without a statistically significant difference between the two groups ( P = 0.801 ) .
RESULTS	An increased creatine kinase isoenzyme MB level of greater than two times the upper limit of normal was found in 10 cases ( 3.1 % ) in group 1 and 12 cases ( 2.9 % ) in group 2 , without a statistically significant difference between the two groups ( P = 0.894 ) .
RESULTS	Postoperative bleeding was observed in nine patients ( 2.8 % ) in group 1 and six patients ( 1.5 % ) in group 2 .
RESULTS	Postoperative MACEs were observed in two patients ( 0.6 % ) in group 1 and two patients ( 0.5 % ) in group 2 .
RESULTS	There were no significant differences between the two groups with respect to bleeding events or MACEs .
CONCLUSIONS	Our study showed that dalteparin might be as effective and safe as unfractionated heparin for anticoagulation during elective PCI .

###24735128
BACKGROUND	In patients with asthma , single doses of inhaled glucocorticosteroids ( ICS ) have been reported to have antiinflammatory actions that can be detected several hours after drug administration .
BACKGROUND	However , the onset and duration of the effect have not been investigated .
BACKGROUND	We therefore measured airway blood flow ( [ Formula : see text ] aw ) as an index of airway inflammation to determine the time course and dose dependence of the antiinflammatory action of an ICS in 20 patients with moderate asthma receiving regular ICS treatment .
METHODS	[ Formula : see text ] aw and spirometry were measured before and serially for 360 minutes after a single inhaled dose of 360 g , 720 g , and 1,440 g budesonide or placebo as well as after four repetitive 720-g budesonide doses given 30 minutes apart .
RESULTS	Baseline mean [ Formula : see text ] aw was increased and FEV1 was decreased without significant differences among the 5 treatment days .
RESULTS	After budesonide inhalation , there was a transient , dose-dependent decrease in mean [ Formula : see text ] aw from 12 to 21 % , with significant differences from baseline at 60 and 90 minutes for the 720-g and 1,440-g doses ( P < 0.05 ) .
RESULTS	Thirty minutes after four repetitive budesonide administrations , mean [ Formula : see text ] aw was 28 % below baseline ( P < 0.05 ) and remained 11 % below baseline after 270 minutes .
RESULTS	There was no change in mean FEV1 after any of the treatments .
CONCLUSIONS	In subjects with moderate asthma who use ICS regularly , inhaled budesonide caused a transient dose-dependent vasoconstriction in the airway , thereby reversing one manifestation of airway inflammation .
CONCLUSIONS	These results suggest that a pure controller medication can have immediate beneficial effects not paralleled by changes in airflow .
CONCLUSIONS	Clinical trial registered with www.clinicaltrials.gov ( NCT 01219738 ) .

###25424952
BACKGROUND	No immunogenicity data has been reported after a single dose of the quadrivalent HPV vaccine ( qHPV-Gardasil ) and no data are available on co-administration of this vaccine with the HAV/HBV vaccine ( Twinrix-Junior ) .
BACKGROUND	Two pre-licensure studies reported similar anti-HPV but lower anti-HBs titers when co-administering HPV and HBV vaccines .
OBJECTIVE	To assess the immunogenicity of the qHPV and HAV/HBV vaccine when co-administered ( Group-Co-adm ) or given one month apart ( Group-Sep ) and to measure the persistence of HPV antibodies three years post-second dose of qHPV vaccine in both study groups .
METHODS	416 9-10 year-old girls were enrolled .
METHODS	Vaccination schedule was 0-6 months .
METHODS	Anti-HAV and anti-HBs were measured in all subjects 6 months post-first dose and 1 month post-second dose .
METHODS	Anti-HPV were measured 6 months post-first dose in Group-Co-adm and in all subjects 1 and 36 months post-second dose .
RESULTS	Six months post-first dose : 100 % of subjects had detectable anti-HAV and 56 % and 73 % had detectable anti-HBs in Group-Co-Adm and Group-Sep , respectively .
RESULTS	In Group-Co-adm 94 , 100 , 99 and 96 % had detectable antibodies to HPV 6 , 11 , 16 and 18 , respectively .
RESULTS	One month post-second dose of qHPV and HAV/HBV vaccine , in both study groups 99.5-100 % of subjects had an anti-HAV titer 20IU/L , 97.5-97 .6 % an anti-HBs level 10IU/L , and 100 % had an anti-HPV titer 3LU .
RESULTS	Thirty-six months post-second dose of qHPV all but four subjects ( 99 % ) had antibodies to HPV18 and 100 % had antibodies to HPV6 , 11 and 16 .
RESULTS	The great majority ( 97-100 % ) had an anti-HPV titer 3 LU .
RESULTS	Post-second dose administration of qHPV and HAV/HBV , no meaningful difference was observed in the immune response in the two study groups to any component of vaccines .
CONCLUSIONS	The results indicate that qHPV and HAV/HBV can be given during the same vaccination session .
CONCLUSIONS	Two doses of of qHPV and HAV/HBV vaccines induce a strong immune response .
CONCLUSIONS	Three years post-second dose of qHPV , the great majority of subjects had antibodies to HPV types included in the vaccine .
CONCLUSIONS	A two-dose schedule for pre-adolescents might be a reasonable alternative to the currently approved three-dose schedules .

###25919835
OBJECTIVE	To compare outcomes between increasing versus maintaining the dose of mirtazapine in patients with depression without initial improvement .
METHODS	Data from a 6-week double-blind randomized placebo-controlled trial of mirtazapine in major depressive disorder ( DSM-IV ) conducted from November 2004 to December 2005 were used .
METHODS	Percentages of remitters ( ie , a score of 7 in the 17-item Hamilton Depression Rating Scale [ HDRS-17 ] ) and HDRS-17 score changes from baseline to week 6 were compared in the following 2 pairs , using Fisher exact test or mixed-effects model for repeated measures : ( 1 ) subjects who failed to show a 20 % decrease in the HDRS-17 total scores at week 1 but were assigned to continue 15 mg/d ( stay ( 15 ) group ) versus those who were assigned to increase the dose to 30 mg/d ( increase ( 30 ) group ) and ( 2 ) subjects who failed to show a 20 % decrease in the HDRS-17 total scores with 30 mg/d at week 2 but were assigned to continue 30 mg/d ( stay ( 30 ) group ) versus those who were assigned to increase the dose to 45 mg/d ( increase ( 45 ) group ) .
RESULTS	The increase ( 30 ) group showed a numerically but not significantly higher remission rate and a significantly greater decrease in the HDRS-17 total score at week 6 than the stay ( 15 ) group ( 34.7 % [ 8 of 23 patients ] vs 14.3 % [ 3 of 21 patients ] , P = .2 ; least squares mean , -15.8 vs -10.9 , P = .003 ) .
RESULTS	No significant differences were found between the increase ( 45 ) and stay ( 30 ) groups .
CONCLUSIONS	Dose increase of mirtazapine from 15 mg/d to 30 mg/d may be effective for patients with depression without initial improvement .
CONCLUSIONS	However , effectiveness may not be the case beyond 30 mg/d .
BACKGROUND	JapicCTI identifier : 152830 .

###25007860
BACKGROUND	The effects that artemether-lumefantrine ( AL ) has on gametocyte dynamics in the short-term have recently been described .
BACKGROUND	However there is limited long-term longitudinal data on the effect of AL on gametocyte dynamics in asymptomatic children .
METHODS	An epidemiological study was conducted in Kombewa , Western Kenya , in which 270 asymptomatic children aged between 12 and 47 months were enrolled .
METHODS	The subjects were randomized to receive either a course of AL or placebo at enrolment .
METHODS	Active follow-up was conducted for one year .
RESULTS	The gametocyte prevalence and density dynamics throughout the study period mirrored that of the asexual forms .
RESULTS	The proportion of initially parasitaemic subjects becoming gametocytaemic was significantly lower in the AL arm for the first 12 weeks following randomization .
RESULTS	The geometric mean gametocyte density was lower in the AL arm for 2 weeks following randomization .
RESULTS	None of the variables of interest had a statistically significant effect on the duration of gametocytaemia .
RESULTS	There is no effect seen in subjects who are not parasitaemic at the time of drug administration .
CONCLUSIONS	The treatment of asymptomatic parasitaemic subjects with AL results in a significant reduction in the proportion of subjects who become gametocytaemic for at least 12 weeks .

###24377964
BACKGROUND	The National Athletic Trainers ' Association position statement on acute management of the cervical spine-injured athlete recommended the all-or-nothing endeavor , which involves removing or not removing both helmet and shoulder pads , from equipment-laden American football and ice hockey athletes .
BACKGROUND	However , in supporting research , investigators have not considered alternative protocols .
OBJECTIVE	To measure cervical spine movement ( head relative to sternum ) produced when certified athletic trainers ( ATs ) use the all-or-nothing endeavor and to compare these findings with the movement produced using an alternative pack-and-fill protocol , which involves packing the area under and around the cervical neck and head with rolled towels .
METHODS	Crossover study .
METHODS	Movement analysis laboratory .
METHODS	Eight male collegiate football players ( age = 21.4 1.4 years ; height = 1.87 0.02 m ; mass = 103.6 12.5 kg ) .
METHODS	Four ATs removed equipment under 4 conditions : removal of helmet only followed by placing the head on the ground ( H ) , removal of the helmet only followed by pack-and-fill ( HP ) , removal of the helmet and shoulder pads followed by placing the head on the ground ( HS ) , and removal of the helmet and shoulder pads followed by pack-and-fill ( HSP ) .
METHODS	Motion capture was used to track the movement of the head with respect to the sternum during equipment removal .
METHODS	We measured head movement relative to sternum movement ( translations and rotations ) .
METHODS	We used 4 4 analyses of variance with repeated measures to compare discrete motion variables ( changes in position and total excursions ) among protocols and ATs .
RESULTS	Protocol HP resulted in a 0.1 0.6 cm rise in head position compared with a 1.4 0.3 cm drop with protocol HS ( P < .001 ) .
RESULTS	Protocol HP produced 4.9 less total angular excursion ( P < .001 ) and 2.1 cm less total vertical excursion ( P < .001 ) than protocol HS .
CONCLUSIONS	The pack-and-fill protocol was more effective than shoulder pad removal in minimizing cervical spine movement throughout the equipment-removal process .
CONCLUSIONS	This study provides evidence for including the pack-and-fill protocol in future treatment recommendations when helmet removal is necessary for on-field care .

###25257907
OBJECTIVE	The primary objective of this study was to compare the utility of high-speed video ( HSV ) to videostroboscopy ( VS ) in the assessment of adolescents with normal and abnormal larynges .
OBJECTIVE	A secondary objective was to evaluate the ease of assessment of adolescents with HSV .
METHODS	Case series with chart review .
METHODS	Tertiary academic health care center .
METHODS	This study involved a retrospective review of recordings of 7 adolescents assessed with both HSV and VS. The 14 recordings were randomized and presented to 4 groups of blinded evaluators : 2 fellowship-trained laryngologists , 2 speech language pathologists ( SLP ) with multiyear experience working in a voice clinic , 2 pediatric otolaryngologists , and 2 otolaryngology residents .
METHODS	Raters were asked to evaluate the videos using a standardized scoring tool .
METHODS	Raters also completed a questionnaire assessing their opinion of the HSV and VS recordings .
RESULTS	Evaluators required more time to complete their assessment of VS recordings ( 2.95 min 2.41 min ) than HSV recordings ( 2.31 min 1.92 min ) ( P = .004 ) .
RESULTS	There was no difference in ease of evaluation ( P = .878 ) or diagnostic accuracy within evaluator groups by recording modality ( P = .5 ) .
RESULTS	The overall agreement between VS and HSV was moderate ( kappa [ SE ] = 0.446 [ 0.029 ] ) .
RESULTS	The debrief questionnaire revealed that 5 of 8 ( 62.5 % ) preferred VS to HSV .
CONCLUSIONS	This is the first comparative study between HSV and VS in patients under 18 years of age .
CONCLUSIONS	HSV permitted faster evaluation than VS , but there was no difference in diagnostic accuracy between the 2 modalities .
CONCLUSIONS	The evaluators preferred VS to HSV .

###24330156
BACKGROUND	In the present study , we examined the effect of a two-herb traditional Chinese medicine ( NF3 ) , comprised of Astragali Radix and Radix Rehmanniae , on the healing of diabetic foot ulcer and the possible molecular mechanisms involved .
METHODS	This was a prospective randomized double-blind placebo-controlled study .
METHODS	Sixteen diabetic patients were randomized to receive either placebo or NF3 for 6 months .
METHODS	Ulcer healing and sensory changes were examined .
METHODS	Molecular studies included measurement of serum tumor necrosis factor ( TNF ) - and RNA microarray investigation .
RESULTS	The daily rate of reduction in ulcer area was 3.55 % in the NF3 group and 1.52 % in the placebo group ( P = 0.062 ) .
RESULTS	In the index limb , the number of negative tests for sensory neuropathy using monofilament was reduced from 27 % to 7 % in the NF3 group and from 37 % to 35 % in the placebo group ( P < 0.001 ) .
RESULTS	In addition , NF3 significantly decreased serum TNF - levels ( P = 0.034 ) .
RESULTS	Microarray studies revealed concerted changes following NF3 treatment in the expression of genes implicated in fibroblast regeneration , angiogenesis , and anti-inflammation .
CONCLUSIONS	In this proof-of-concept study , 6-month treatment with NF3 was associated with improved wound healing and sensation accompanied by concerted changes in gene expression .

###25142039
BACKGROUND	N-methyl-D-aspartate receptor antagonists are potential therapies for neuropathic pain , and memantine has a good tolerance profile .
BACKGROUND	A preclinical study recently reported that presurgery memantine may prevent neuropathic pain development and cognition dysfunction .
BACKGROUND	Considering the high prevalence of breast cancer and of post-mastectomy neuropathic pain , a clinical trial is carried out to evaluate if memantine may prevent neuropathic pain development and maintain cognitive function and quality of life in cancer patients .
METHODS	A randomized clinical trial ( NCT01536314 ) includes 40 women with breast cancer undergoing mastectomy at the Oncology Hospital , Clermont-Ferrand , France .
METHODS	Memantine ( 5 to 20mg/day ; n = 20 ) or placebo ( n = 20 ) is administered for 4 weeks starting 2 weeks before surgery .
METHODS	Intensity of pain , cognitive function , quality of life and of sleep , anxiety and depression are evaluated with questionnaires .
METHODS	The primary endpoint is pain intensity on a 0 to 10 ) numerical scale at 3months post-mastectomy .
METHODS	Data analysis is performed using mixed models and the tests are two-sided , with a type I error set at = 0.05 .
CONCLUSIONS	The hypothesis of this translational approach is to confirm in patients the beneficial prophylactic effect of memantine observed in animals .
CONCLUSIONS	Such a protective action of memantine against neuropathic pain and cognitive dysfunction would greatly improve the quality of life of cancer patients .
BACKGROUND	ClinicalTrials.gov : NCT01536314 on 16 February 2012 .

###24833646
OBJECTIVE	To investigate the feasibility and effectiveness of Sonas , a group intervention involving multisensory stimulation , reminiscence , and light physical activity .
METHODS	A total of 39 participants with moderate to severe dementia were randomized to receive either 14 sessions of Sonas or treatment as usual .
METHODS	Measures such as quality of life ( QoL ) , communication , depression , anxiety , and behavioral disturbance were administered at baseline and follow-up .
RESULTS	No statistically significant results were found .
RESULTS	However , participant attendance to sessions was good ( mean = 12.4 sessions of 14 offered ) .
CONCLUSIONS	Sonas sessions did not lead to improvements in QoL and behavioral and psychological symptoms of dementia .

###25063466
BACKGROUND	Three-dimensional echocardiography ( 3DE ) is a reliable and reproducible tool for assessing left ventricular ( LV ) function but remains sensitive to patient echogenicity .
BACKGROUND	Contrast-enhanced 3DE ( C3DE ) has the potential to improve quantification in challenging patients .
BACKGROUND	The aim of this study was to evaluate the impact of temporal resolution , spatial resolution , and image dynamic range on LV function assessed using C3DE compared with cardiac magnetic resonance imaging ( MRI ) in patients with poor echogenicity .
METHODS	Forty-one patients with poor echogenicity who underwent two-dimensional echocardiography ( 2DE ) , 3DE , C3DE , and MRI were retrospectively investigated .
RESULTS	Before contrast injection , 24 patients had three or more nonvisible segments .
RESULTS	Three cases of 2DE and 12 cases of 3DE were not suitable for quantification .
RESULTS	LV end-diastolic volumes were systematically underestimated by 2DE ( 142 58 mL ) , 3DE ( 146 69 mL ) , and C3DE ( 172 61 mL ) compared with MRI ( 216 85 mL ) ( P < .001 ) .
RESULTS	Similar results were found for LV end-systolic volumes ( 81 65 mL for 2DE , 82 69 mL for 3DE , and 102 80 mL for C3DE vs 129 94 mL for MRI ; P < .001 ) .
RESULTS	C3DE provided the best agreement with MRI ( Lin concordance correlation coefficients of 0.67 , 0.93 , and 0.99 , respectively , for end-diastolic volume , end-systolic volume , and ejection fraction ) as well as the best measurement reproducibility .
RESULTS	Finally , ultrasound settings had no significant effect on LV volumes and ejection fraction measurements .
CONCLUSIONS	In these patients with poor ultrasound image quality , C3DE , regardless of instrument settings , outperformed 2DE and 3DE to assess LV volumes and ejection fraction and can thus be proposed as an acceptable alternative when MRI can not be performed in this subgroup .

###25386795
BACKGROUND	Pulmonologists frequently encounter indeterminate pulmonary nodules in practice , but it is unclear what clinical factors they rely on to guide the diagnostic evaluation .
OBJECTIVE	To assess the current approach to the management of indeterminate pulmonary nodules and to determine the extent to which the addition of a hypothetical diagnostic blood test will influence clinical decision making .
METHODS	Selected pulmonologists practicing in the United States were invited to participate in a conjoint exercise based on 20 randomly generated cases of varying age , smoking history , and nodule size .
METHODS	Some cases included the result of a hypothetical blood test .
METHODS	Each respondent chose from among three diagnostic options for a patient : noninvasive monitoring ( i.e. , serial CT or positron emission tomography scan ) , a minor procedure ( i.e. , biopsy or bronchoscopy ) , or a major procedure ( i.e. , video-assisted thorascopic surgery or thoracotomy ) .
METHODS	Multivariate logistic regression was used to assess the impact of the three risk factors and the diagnostic blood test on decision making .
RESULTS	Four hundred nineteen physicians participated ( response rate , 10 % ) .
RESULTS	One hundred fifty-three physician surveys met predetermined criteria and were analyzed ( 4 % of all invitees ) .
RESULTS	A diagnostic procedure was recommended for 23 % of 6-mm nodules , versus 54 , 66 , 77 , and 84 % of nodules 10 , 14 , 18 , and 22 mm , respectively ( P < 0.001 ) .
RESULTS	Older age limited recommendations for invasive testing : 54 % of 80-year-olds versus 61 , 64 , 63 , and 61 % of patients 71 , 62 , 53 , and 44 years of age , respectively ( P < 0.001 ) .
RESULTS	In multivariate analyses , nodule size , smoking history , age , and the blood test each influenced decision making ( P < 0.001 ) .
CONCLUSIONS	The pulmonologists who participated in this survey were more likely to proceed with invasive testing , instead of observation or additional imaging , as the size of the nodule increased .
CONCLUSIONS	The use of a hypothetical blood test resulted in significant alterations in the decision to pursue invasive testing .

###24559816
OBJECTIVE	To examine the effects of music listening on sleep quality amongst older community-dwelling adults in Singapore .
METHODS	In a randomized controlled study , a cohort of older adults ( N = 60 ) age 55 years or above were recruited in one community centre .
METHODS	Sleep quality , as measured by the Pittsburgh Sleep Quality Index ( PSQI ) , was the primary outcome .
METHODS	Participants ' demographic variables including age , gender , religion , education level , marital and financial status , any chronic illness , previous experiences of music intervention as well as depression levels were collected .
METHODS	Participants were asked to listen to soft , instrumental slow sedative music without lyrics , of approximately 60-80 beats per minute , and 40 min in duration , for 6 weeks .
METHODS	Generalized estimating equations were used to examine the effects of the intervention on the elders ' sleep quality .
RESULTS	Significant reductions in PSQI scores were found in the intervention group ( n = 28 ) from baseline ( meanSD , 10.22.5 ) to week 6 ( 5.92.4 , p < 0.001 ) , while there were no changes in the control group ( n = 32 ) from baseline ( 9.02.4 ) to week 6 ( 9.52.6 ) .
RESULTS	At week 6 , the intervention group showed a better sleep quality than the control ( ( 2 ) = 61.84 , p < 0.001 ) .
CONCLUSIONS	Notwithstanding the placebo effect , this study supports music listening as an effective intervention for older adults to improve sleep quality .
CONCLUSIONS	Not only does this process improve their sleeping quality at old age , it also individualizes and enhances the quality of care provided by the healthcare provider as the therapeutic relationship between provider and client is being established .
CONCLUSIONS	Contemporary gerontology is progressively characterized by collaboration between several approaches with the intent to comprehend the mental aspects of the multifarious process of ageing .
CONCLUSIONS	Music listening is one such avenue to enhance sleep quality amongst older adults and make an essential contribution to healthy ageing .

###25799356
OBJECTIVE	Hypoxia is a major complication in dental patients under intravenous sedation ( IVS ) .
OBJECTIVE	A nasal high-flow ( NHF ) system has been reported to achieve effective oxygenation in patients with sleep apnea syndrome .
OBJECTIVE	This study investigated the ability of the NHF system to prevent hypoxia in dental patients under IVS .
METHODS	Thirty patients scheduled for dental treatment under IVS were enrolled .
METHODS	Patients were randomly divided into 3 groups : patients spontaneously breathing oxygen at 5L/minute through a nasal cannula ( NC5 group ) , patients administered oxygen at 30L/minute through the NHF system , and patients administered oxygen at 50L/minute through the NHF system .
METHODS	Hypnosis was induced by bolus administration of midazolam ( 0.05 mg/kg ) followed by continuous administration of propofol ( target blood concentration , 1.2 to 2g/mL ) .
METHODS	Noninvasive blood pressure , peripheral capillary oxygen saturation ( SpO2 ) , heart rate , and bispectral index values were recorded every 2.5 minutes before the induction of anesthesia .
METHODS	Interventions , such as jaw lifting , were recorded during IVS and arterial blood gas analysis was performed at the end of sedation .
METHODS	Patient and surgeon satisfaction with IVS was evaluated by interview .
RESULTS	Minimum SpO2 was lowest in and surgeons were least satisfied with the NC5 group .
RESULTS	In addition , interventions were required most frequently in the NC5 group ( P < .05 ) .
RESULTS	Compared with the NC5 group , use of the NHF system improved partial pressures of oxygen and carbon dioxide in dental patients under IVS ( P < .05 ) .
CONCLUSIONS	These results suggest that use of the NHF system can prevent hypoxia in dental patients under IVS .
CONCLUSIONS	Further studies are necessary to determine the appropriate flow rate and indications for NHF in obese patients .

###25341445
OBJECTIVE	We explored whether readers can understand key messages without having to read the full review , and if there were differences in understanding between various types of summary .
METHODS	A randomised experiment of review summaries which compared understanding of a key outcome .
METHODS	Members of university staff ( n = 36 ) .
METHODS	Universities on the island of Ireland .
METHODS	The Cochrane Review chosen examines the health impacts of the use of electric fans during heat waves .
METHODS	Participants were asked their expectation of the effect these would have on mortality .
METHODS	They were then randomly assigned a summary of the review ( i.e. abstract , plain language summary , podcast or podcast transcription ) and asked to spend a short time reading/listening to the summary .
METHODS	After this they were again asked about the effects of electric fans on mortality and to indicate if they would want to read the full Review .
METHODS	Correct identification of a key review outcome .
RESULTS	Just over half ( 53 % ) of the participants identified its key message on mortality after engaging with their summary .
RESULTS	The figures were 33 % for the abstract group , 50 % for both the plain language and transcript groups and 78 % for the podcast group .
CONCLUSIONS	The differences between the groups were not statistically significant but suggest that the audio summary might improve knowledge transfer compared to written summaries .
CONCLUSIONS	These findings should be explored further using a larger sample size and with other reviews .

###25316469
OBJECTIVE	To compare the effects of regular intermittent bolus versus continuous infusion for epidural labor analgesia on maternal temperature and serum interleukin-6 ( IL-6 ) level .
METHODS	This randomized trial was performed in Nanjing Maternity and Child Health Care Hospital , Nanjing , Jiangsu Province , China between October 2012 and February 2014 .
METHODS	Either regular intermittent bolus ( RIB , n = 66 ) or continuous infusion ( CI , n = 66 ) was used for epidural labor analgesia .
METHODS	A bolus dose ( 10 ml of 0.08 % ropivacaine + 0.4 ugml-1 sufentanil ) was manually administrated once an hour in the RIB group , whereas the same solution was continuously infused at a constant rate of 10 mlh-1 in the CI group .
METHODS	Maternal tympanic temperature and serum IL-6 level were measured hourly from baseline to one hour post partum .
METHODS	The incidences of fever ( > / = 38 degree celsius ) were calculated .
RESULTS	The incidence of maternal fever was similar between the 2 groups .
RESULTS	There was a rising trend in mean temperature over time in both groups , but no statistical difference was detected between the groups at respective time points ; maternal serum IL-6 showed similar changes .
CONCLUSIONS	Compared with continuous infusion , regular intermittent bolus presents with the same incidence of maternal fever for epidural labor analgesia .
CONCLUSIONS	Interleukin-6 elevation could be involved in mean maternal temperature increase .

###25255414
BACKGROUND	Teaching resident physicians to appropriately document patient diagnoses in the medical record is critical to ensure accuracy of publicly reported data and to enable quality improvement initiatives .
BACKGROUND	We sought to determine if providing real-time feedback to resident or attending physicians would lead to improved medical documentation .
METHODS	We audited charts to determine if target diagnoses were present and documented .
METHODS	After a baseline data-gathering period , during the intervention period the first author randomly provided feedback to either residents alone or residents plus their attending physicians .
METHODS	Capture rates for targeted diagnoses , total diagnoses documented and coded , severity of illness ( SOI ) , risk of mortality ( ROM ) , and case mix index were compared pre - and postintervention .
RESULTS	During the intervention , the proportion of target diagnoses captured increased from 30 % to 54 % ( P < 0.001 ) , as did the median ( interquartile [ IQ ] range ) number of diagnoses captured ( from 11 [ IQ range , 8-13 ] to 12 [ IQ range , 9-16 ] , P < 0.05 ) .
RESULTS	We also achieved significant increases in median ( IQ range ) SOI scores ( from 2 [ IQ range , 2-3 ] to 3 [ IQ range , 2-3 ] , P = 0.04 ) and complication code capture ( 61 % vs 75 % , P = 0.01 ) .
RESULTS	However , there was no significant increase in ROM , case mix index , or hospital billing .
RESULTS	Notifying attending physicians in addition to residents was of no benefit .
CONCLUSIONS	An educational program based on real-time feedback to resident physicians regarding documentation improved diagnostic capture and SOI scores , but not case mix index or billing at our public , safety net , teaching hospital .
CONCLUSIONS	Even with enhanced education of resident physicians regarding documentation , other interventions are needed to further improve diagnostic capture .

###24858657
BACKGROUND	In this substudy of the effect of dietary nitrate on blood pressure , endothelial function , and insulin sensitivity in type 2 diabetes , we report the development of a novel nitrate depleted beetroot juice for use clinical trials and determine if dietary nitrate supplementation improved cognitive function in patients with type 2 diabetes mellitus .
METHODS	Beetroot juice was treated with the anion exchange resin Purolite A520e .
METHODS	UV-vis-spectrophotometry , and a blind taste test were performed along with determination of sugar content , measurement of ascorbate and dehydroascorbate , the ionic composition of juice and Proton NMR .
METHODS	Subsequently , 27 patients , age 67.24.9 years , ( 18 male ) were recruited for a double blind , randomised , placebo-controlled crossover trial .
METHODS	Participants were randomised to begin in either order beetroot juice ( nitrate content 7.5 mmol per 250 ml ) or placebo ( nitrate depleted beetroot juice nitrate content 0.002 mmol per 250 ml ) .
METHODS	At the end of each 2 week supplementation period cognitive function was assessed using E-prime , E-Studio software with 5 separate tests being performed .
METHODS	The tests utilised in the present study have been adapted from the Cambridge Neuropsychological Test Automated Battery ( CANTAB ) .
RESULTS	The differences in the UV-vis spectra were comparable to the natural variation found in differing cultivars .
RESULTS	There were no discernable differences in taste , sugar content , or Proton NMR .
RESULTS	Ascorbate and dehydroascorbate were undetectable in either juice .
RESULTS	After 2 weeks of beetroot juice simple reaction time was significantly quicker in the active arm at 32740 ms versus 341.852.7 ms in the placebo arm , mean difference 13.925.6 ms ( 95 % CI 3.8-24 .0 ms ) , p = 0.009 .
RESULTS	No other measures of cognitive function differed between treatment arms .
CONCLUSIONS	We have developed an effective placebo beetroot juice for use in trials of supplementation of dietary nitrate .
CONCLUSIONS	Two weeks supplementation of the diet with 7.5 mmol of nitrate per day caused a significant improvement in simple reaction time in individuals with T2DM .

###24655569
BACKGROUND	Dental anxiety and anxiety-related avoidance of dental care create significant problems for patients and the dental profession .
BACKGROUND	Distraction interventions are used in daily medical practice to help patients cope with unpleasant procedures .
BACKGROUND	There is evidence that exposure to natural scenery is beneficial for patients and that the use of virtual reality ( VR ) distraction is more effective than other distraction interventions , such as watching television .
BACKGROUND	The main aim of this randomized controlled trial is to determine whether the use of VR during dental treatment can improve the overall dental experience and recollections of treatment for patients , breaking the negative cycle of memories of anxiety leading to further anxiety , and avoidance of future dental appointments .
BACKGROUND	Additionally , the aim is to test whether VR benefits dental patients with all levels of dental anxiety or whether it could be especially beneficial for patients suffering from higher levels of dental anxiety .
BACKGROUND	The third aim is to test whether the content of the VR distraction can make a difference for its effectiveness by comparing two types of virtual environments , a natural environment and an urban environment .
METHODS	The effectiveness of VR distraction will be examined in patients 18years or older who are scheduled to undergo dental treatment for fillings and/or extractions , with a maximum length of 30minutes .
METHODS	Patients will be randomly allocated into one of three groups .
METHODS	The first group will be exposed to a VR of a natural environment .
METHODS	The second group will be exposed to a VR of an urban environment .
METHODS	A third group consists of patients who receive standard care ( control group ) .
METHODS	Primary outcomes relate to patients ' memories of the dental treatment one week after treatment : ( a ) remembered pain , ( b ) intrusive thoughts and ( c ) vividness of memories .
METHODS	Other measures of interest are the dental experience , the treatment experience and the VR experience .
BACKGROUND	Current Controlled Trials ISRCTN41442806 .

###25811573
BACKGROUND	Placement of a totally implantable venous access device in children with cancer often leads to hypertrophic scars after its removal .
BACKGROUND	This study investigates whether the use of silicone gel sheets has a beneficial effect on scar outcome in children with cancer .
METHODS	In a three-arm randomized controlled trial , the effects of use of silicone gel sheets for 2 and 6 months were assessed and compared with no intervention in children with cancer after removal of the totally implantable venous access device .
METHODS	Silicone gel sheets were first administered 14 days after surgery .
METHODS	The 1-year follow-up included measurements at seven time points .
METHODS	Next to scar size assessment , the modified Vancouver Scar Scale was used to assess scar outcome .
RESULTS	Thirty-six children participated .
RESULTS	For hypertrophy , no significant differences were found between the two intervention groups and the control group .
RESULTS	However , at 1-year follow-up , the 2-month application group showed significantly smaller scars compared with the group receiving silicone gel sheet treatment for 6 months ( p = 0.04 ) , but not when compared with the control group ( p = 0.22 ) .
RESULTS	Longitudinal multilevel analyses could not confirm these findings and showed no significant intervention effects on both outcomes .
CONCLUSIONS	This study provides no strong evidence to support the use of silicone gel sheets after totally implantable venous access device removal in children with cancer .
CONCLUSIONS	There seems to be a small benefit for scar width with application for 2 months .
CONCLUSIONS	However , for hypertrophy , the scar outcome shows no significant difference between the control group and the 2-month and 6-month treatment groups .

###25220046
BACKGROUND	The prevention and treatment of overweight and obese individuals on a population-wide basis is challenging because patients have difficulties with adhering to weight loss programmes .
BACKGROUND	The present study aimed to evaluate patients ' adherence to the weight reduction programme by identifying factors predictive of both drop-out rate and weight loss success .
METHODS	One-hundred and twenty-four obese patients participated in a 12-month weight reduction programme , involving group therapy during an intensive 5-day educational intervention , followed by five , 2-h follow-up visits .
METHODS	The primary outcome measures included drop-out rate and percentage weight loss .
METHODS	Sociodemographic and clinical characteristics , as well as type of diet , were explored as potential predictive factors .
METHODS	Type of diet was assigned based on randomisation .
METHODS	Regression analyses were conducted to identify predictive variables of drop-out and weight loss success .
RESULTS	In total , 33.1 % of all recruited participants were deemed successful because they reduced the initial weight by more than 5 % after the 12-month intervention .
RESULTS	The overall attrition rate was 32.3 % .
RESULTS	In a multiple regression model , initial weight loss and marital status were the strongest predictors of weight loss success after 1-year period ( r ( 2 ) = 0.481 , P < 0.001 ) .
RESULTS	In a separate analysis , subjects more likely to drop-out were those with a lower educational level [ odds ratio ( OR ) = 3.26 , 95 % confidence interval ( CI ) = 1.22-8 .70 , P = 0.018 ] and a higher level of obesity ( OR = 0.974 , 95 % CI = 0.95-0 .99 , P = 0.010 ) .
CONCLUSIONS	The present study demonstrates that initial weight loss at 1 month made the strongest unique contribution to the prediction of percentage weight loss after 12 months , whereas being married was a negative predictor .
CONCLUSIONS	Those with a lower educational level and a higher level of obesity were more likely to drop-out .

###24343290
BACKGROUND	Chronic pain remains a significant challenge for modern health care as its pathologic mechanisms are largely unknown and preclinical animal models suffer from limitations in assessing this complex subjective experience .
BACKGROUND	However , human brain neuroimaging techniques enable the assessment of functional and neurochemical alterations in patients experiencing chronic pain and how these factors may dynamically change with pharmacologic treatment .
METHODS	To identify the clinical action of pregabalin , a proven analgesic , the authors performed three complementary brain neuroimaging procedures : ( proton magnetic resonance spectroscopy , functional magnetic resonance imaging , and functional connectivity magnetic resonance imaging ) in 17 chronic pain patients diagnosed with fibromyalgia .
RESULTS	The authors found that pregabalin but not placebo reduces combined glutamate + glutamine levels within the posterior insula ( pregabalin P = 0.016 ; placebo P = 0.71 ) .
RESULTS	Interestingly , reductions in clinical pain were associated with reductions in brain connectivity of this structure to brain regions within the default mode network during pregabalin ( r = 0.82 ; P = 0.001 ) but not placebo ( r = -0.13 ; P = 0.63 ) .
RESULTS	Response of default mode network regions to experimental pain was also reduced with pregabalin ( P = 0.018 ) but not placebo ( P = 0.182 ) .
RESULTS	Perhaps most importantly , baseline values for all three neuroimaging markers predicted subsequent analgesic response to pregabalin but not placebo .
CONCLUSIONS	The results of this study suggest that pregabalin works in part by reducing insular glutamatergic activity , leading to a reduction of the increased functional connectivity seen between brain regions in chronic pain states .
CONCLUSIONS	The study also supports a role for human brain imaging in the development , assessment , and personalized use of central-acting analgesics .

###26393847
OBJECTIVE	Agitation is common among patients with Alzheimer disease ; safe , effective treatments are lacking .
OBJECTIVE	To assess the efficacy , safety , and tolerability of dextromethorphan hydrobromide-quinidine sulfate for Alzheimer disease-related agitation .
METHODS	Phase 2 randomized , multicenter , double-blind , placebo-controlled trial using a sequential parallel comparison design with 2 consecutive 5-week treatment stages conducted August 2012-August 2014 .
METHODS	Patients with probable Alzheimer disease , clinically significant agitation ( Clinical Global Impressions-Severity agitation score 4 ) , and a Mini-Mental State Examination score of 8 to 28 participated at 42 US study sites .
METHODS	Stable dosages of antidepressants , antipsychotics , hypnotics , and antidementia medications were allowed .
METHODS	In stage 1 , 220 patients were randomized in a 3:4 ratio to receive dextromethorphan-quinidine ( n = 93 ) or placebo ( n = 127 ) .
METHODS	In stage 2 , patients receiving dextromethorphan-quinidine continued ; those receiving placebo were stratified by response and rerandomized in a 1:1 ratio to dextromethorphan-quinidine ( n = 59 ) or placebo ( n = 60 ) .
METHODS	The primary end point was change from baseline on the Neuropsychiatric Inventory ( NPI ) Agitation/Aggression domain ( scale range , 0 [ absence of symptoms ] to 12 [ symptoms occur daily and with marked severity ] ) .
RESULTS	A total of 194 patients ( 88.2 % ) completed the study .
RESULTS	With the sequential parallel comparison design , 152 patients received dextromethorphan-quinidine and 127 received placebo during the study .
RESULTS	Analysis combining stages 1 ( all patients ) and 2 ( rerandomized placebo nonresponders ) showed significantly reduced NPI Agitation/Aggression scores for dextromethorphan-quinidine vs placebo ( ordinary least squares z statistic , -3.95 ; P < .001 ) .
RESULTS	In stage 1 , mean NPI Agitation/Aggression scores were reduced from 7.1 to 3.8 with dextromethorphan-quinidine and from 7.0 to 5.3 with placebo .
RESULTS	Between-group treatment differences were significant in stage 1 ( least squares mean , -1.5 ; 95 % CI , -2.3 to -0.7 ; P < .001 ) .
RESULTS	In stage 2 , NPI Agitation/Aggression scores were reduced from 5.8 to 3.8 with dextromethorphan-quinidine and from 6.7 to 5.8 with placebo .
RESULTS	Between-group treatment differences were also significant in stage 2 ( least squares mean , -1.6 ; 95 % CI , -2.9 to -0.3 ; P = .02 ) .
RESULTS	Adverse events included falls ( 8.6 % for dextromethorphan-quinidine vs 3.9 % for placebo ) , diarrhea ( 5.9 % vs 3.1 % respectively ) , and urinary tract infection ( 5.3 % vs 3.9 % respectively ) .
RESULTS	Serious adverse events occurred in 7.9 % with dextromethorphan-quinidine vs 4.7 % with placebo .
RESULTS	Dextromethorphan-quinidine was not associated with cognitive impairment , sedation , or clinically significant QTc prolongation .
CONCLUSIONS	In this preliminary 10-week phase 2 randomized clinical trial of patients with probable Alzheimer disease , combination dextromethorphan-quinidine demonstrated clinically relevant efficacy for agitation and was generally well tolerated .
BACKGROUND	clinicaltrials.gov Identifier : NCT01584440 .

###24531662
BACKGROUND	End-stage renal disease patients on hemodialysis are on complex drug regimens consisting of multiple medications , many of which are administered in several doses per day .
BACKGROUND	Consequently , such patients are at high risk for developing drug therapy-related problems ( DTRPs ) .
BACKGROUND	The aim of this study was to detect DTRPs in children undergoing hemodialysis and to assess and evaluate the impact of interventions by the clinical pharmacist on the clinical outcome of children undergoing hemodialysis .
METHODS	Fifty hemodialysis outpatients were randomly divided into two groups ( 25 each ) : the control group and the test group .
METHODS	During the 9-month study period , patients in the control group received the usual medical care , and those in the test group received pharmaceutical care 3 times weekly in addition to the usual medical care .
RESULTS	After 9 months of pharmaceutical care implementation , the test group showed a significant decline in systolic and diastolic blood pressure ( p = 0.0001 ) , serum phosphorus level ( p = 0.006 ) and parathyroid hormone level ( p = 0.001 ) versus their baseline values and versus the control .
RESULTS	The serum Ca * P product level of the test group decreased ( p = 0.001 ) after intervention versus baseline .
RESULTS	Serum calcium level significantly increased in test group ( p = 0.02 ) and decreased in the control group ( p = 0.001 ) versus the respective baseline values .
RESULTS	Satisfaction with the renal treatment significantly improved in the test group ( p = 0.0001 ) versus the control group after 9 months of pharmaceutical care implementation based on Renal Treatment Satisfaction Questionnaire scores .
CONCLUSIONS	Pharmacist-initiated pharmaceutical care improved the satisfaction and biochemical findings of patients on hemodialysis .

###24753120
OBJECTIVE	Motivational Interviewing ( MI ) is a collaborative therapy that focuses on strengthening a person 's internal motivation to change .
OBJECTIVE	Research suggests that MI may be helpful for treating binge eating ; however , findings are limited and little is known about how MI for binge eating compares to active therapy controls .
OBJECTIVE	The present study aimed to build on current research by comparing MI as a prelude to self-help treatment for binge eating with psychoeducation as a prelude to self-help treatment for binge eating .
METHODS	Participants with full or subthreshold DSM-IV Binge Eating Disorder or nonpurging Bulimia Nervosa were randomly assigned to receive either 60 minutes of MI followed by a self-help manual ( n = 24 ) or 60 minutes of psychoeducation followed by a self-help manual ( n = 21 ) .
METHODS	Questionnaires were completed pre - and postsession , and at 1 and 4 months postsession .
RESULTS	MI significantly increased readiness to change and confidence in ability to control binge eating , whereas psychoeducation did not .
RESULTS	No group differences were found when changes in eating disorder attitudes and behaviors were examined .
CONCLUSIONS	MI offers benefits for increasing motivation and self-efficacy .
CONCLUSIONS	However , it may not be a uniquely effective treatment approach for reducing binge eating .

###24694531
OBJECTIVE	This study sought to evaluate the efficacy and safety of subcutaneous evolocumab compared with oral ezetimibe inhypercholesterolemic patients who are unable to tolerate effective statin doses .
BACKGROUND	Statin intolerance , which is predominantly due to muscle-related side effects , is reported in up to 10 % to 20 % of patients .
BACKGROUND	Evolocumab , a fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) , demonstrated marked reductions in plasma low-density lipoprotein cholesterol ( LDL-C ) in a phase 2 study in statin-intolerant patients .
METHODS	The GAUSS-2 ( Goal Achievement after Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects ) trial was a 12-week , double-blind study of randomized patients ( 2:2:1:1 ) to evolocumab 140 mg every two weeks ( Q2W ) or evolocumab 420 mg once monthly ( QM ) both with daily oral placebo or subcutaneous placebo Q2W or QM both with daily oral ezetimibe 10 mg .
METHODS	Co-primary endpoints were percent change from baseline in LDL-C at themean of weeks 10 and12 , and at week 12 .
RESULTS	Three hundred seven patients ( age 62 10 years ; LDL-C 193 59 mg/dl ) were randomized .
RESULTS	Evolocumab reduced LDL-C from baseline by 53 % to 56 % , corresponding to treatment differences versus ezetimibe of 37 % to 39 % ( p < 0.001 ) .
RESULTS	Muscle adverse events occurred in 12 % of evolocumab-treated patients and 23 % of ezetimibe-treated patients .
RESULTS	Treatment-emergent adverse events and laboratory abnormalities were comparable across treatment groups .
CONCLUSIONS	Robust efficacy combined with favorable tolerability makes evolocumab a promising therapy for addressing thelargely unmet clinical need in high-risk patients with elevated cholesterol who are statin intolerant .
CONCLUSIONS	( Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-2 ; NCT01763905 ) .

###24934738
BACKGROUND	Chronic low back pain ( CLBP ) is common and results in significant costs to individuals , families and society .
BACKGROUND	Although some research supports the efficacy of hypnosis for CLBP , we know little about the minimum dose needed to produce meaningful benefits , the roles of home practice and hypnotizability on outcome , or the maintenance of treatment benefits beyond 3 months .
METHODS	One hundred veterans with CLBP participated in a randomized , four-group design study .
METHODS	The groups were ( 1 ) an eight-session self-hypnosis training intervention without audio recordings for home practice ; ( 2 ) an eight-session self-hypnosis training intervention with recordings ; ( 3 ) a two-session self-hypnosis training intervention with recordings and brief weekly reminder telephone calls ; and ( 4 ) an eight-session active ( biofeedback ) control intervention .
RESULTS	Participants in all four groups reported significant pre - to post-treatment improvements in pain intensity , pain interference and sleep quality .
RESULTS	The hypnosis groups combined reported significantly more pain intensity reduction than the control group .
RESULTS	There was no significant difference among the three hypnosis conditions .
RESULTS	Over half of the participants who received hypnosis reported clinically meaningful ( 30 % ) reductions in pain intensity , and they maintained these benefits for at least 6 months after treatment .
RESULTS	Neither hypnotizability nor amount of home practice was associated significantly with treatment outcome .
CONCLUSIONS	The findings indicate that two sessions of self-hypnosis training with audio recordings for home practice may be as effective as eight sessions of hypnosis treatment .
CONCLUSIONS	If replicated in other patient samples , the findings have important implications for the application of hypnosis treatment for chronic pain management .

###26289682
OBJECTIVE	To assess the effects of active music therapy ( MT ) and individualized listening to music ( LtM ) on behavioral and psychological symptoms of dementia ( BPSDs ) in persons with dementia ( PWDs ) .
METHODS	Randomized controlled trial .
METHODS	Nine Italian institutions .
METHODS	Persons with moderate to severe dementia and BPSDs ( N = 120 ) were randomized to one of three treatments .
METHODS	All groups received standard care ( SC ) , and two groups attended 20 individualized MT or LtM sessions , twice a week , in addition to SC .
METHODS	The Neuropsychiatric Inventory ( NPI ) , Cornell Scale for Depression in Dementia ( CSDD ) , and Cornell-Brown Scale for Quality of Life in Dementia ( CBS-QoL ) were administered before treatment , after treatment , and at follow-up to evaluate behavioral and psychological outcomes .
METHODS	A specific coding scheme ( Music Therapy Check List-Dementia ) was used to evaluate the MT process .
RESULTS	Behavioral assessment did not show significant differences between groups .
RESULTS	All groups showed a reduction over time in NPI global score ( P .001 ) , CSDD ( P = .001 ) , and CBS-QoL ( P = .01 ) .
RESULTS	The NPI global score fell 28 % in the MT group , 12 % in the LtM group , and 21 % in the SC group at the end of treatment .
RESULTS	An exploratory post hoc analysis showed similar within-group improvements for the NPI Delusion , Anxiety , and Disinhibition subscales .
RESULTS	In the MT group , communication and relationships between the music therapists and PWDs showed a positive albeit nonsignificant trend during treatment .
CONCLUSIONS	The addition of MT or LtM to standard care did not have a significant effect on BPSDs in PWDs .
CONCLUSIONS	Further studies on the effects of the integration of standard care with different types of music interventions on BPSD in PWD are warranted .

###24916467
BACKGROUND	Endovenous laser ablation ( EVLA ) is a popular treatment for superficial venous insufficiency .
BACKGROUND	Debate continues regarding the optimal management of symptomatic varicose tributaries following ablation of the main saphenous trunk .
BACKGROUND	This randomized trial compared the 5-year outcomes of endovenous laser therapy with ambulatory phlebectomy ( EVLTAP ) with concomitant ambulatory phlebectomy , and EVLA alone with sequential treatment if required following a delay of at least 6weeks .
METHODS	Patients undergoing EVLA for great saphenous vein insufficiency were randomized to receive EVLTAP or EVLA alone with sequential phlebectomy , if required .
METHODS	Outcomes included disease-specific quality of life ( QoL ) ( Aberdeen Varicose Vein Questionnaire ; AVVQ ) , requirement for secondary procedures , clinical severity ( Venous Clinical Severity Score ; VCSS ) , residual and recurrent varicose tributaries , and generic QoL .
METHODS	Patients were followed up for 5years .
RESULTS	Fifty patients were randomized equally into two parallel groups .
RESULTS	The EVLTAP group had lower VCSS scores at 12weeks ( median 0 ( i.q.r. 0-1 ) versus 2 ( 0-2 ) ; P < 0001 ) , and lower AVVQ scores at 6weeks ( median 79 ( i.q.r. 41-107 ) versus 135 ( 109-181 ) ; P < 0001 ) and 12weeks ( 20 ( 04-77 ) versus 96 ( 22-138 ) ; P = 0015 ) .
RESULTS	VCSS and AVVQ scores were equivalent by 1year , but only after 16 of 24 patients in the EVLA group , compared with one of 25 in the EVLTAP group ( P < 0001 ) , had received a secondary intervention .
RESULTS	From 1 to 5 years both groups had equivalent outcomes .
CONCLUSIONS	EVLA with either concomitant or sequential management of tributaries is acceptable treatment for symptomatic varicose veins , with both treatments achieving excellent results at 5years .
CONCLUSIONS	Concomitant treatment of varicosities is associated with optimal improvement in both clinical disease severity and QoL .

###24239167
OBJECTIVE	To explore the outcomes of an Xbox Kinect intervention on balance ability , enjoyment and compliance for previously injured young competitive male athletes .
METHODS	Experimental pre - / post-test design with random assignment .
METHODS	Sixty-three previously injured young competitive male athletes , aged 161 years .
METHODS	Participants were divided into three groups : one group received Xbox Kinect ( XbK ) training , one group received Traditional physiotherapy ( TP ) training , and one group did not receive any balance training ( Control ) .
METHODS	Intervention involved a 24min session , twice weekly for 10 weeks .
METHODS	Overall stability index ( OSI ) and limits of stability ( LOS ) scores using the Biodex Stability System .
METHODS	Enjoyment using the Physical Activity Enjoyment Scale .
METHODS	Self-reported compliance .
RESULTS	Both experimental groups demonstrated an improvement in OSI and LOS mean scores for the right and the left limb after the intervention .
RESULTS	In addition , the results revealed important differences between the experimental groups and the control group on balance test indices .
RESULTS	Group enjoyment rating was greater for XbK compared with TP , while the compliance rating was not .
CONCLUSIONS	These findings suggest that the use of XbK intervention is a valuable , feasible and pleasant approach in order to improve balance ability of previously injured young competitive male athletes .

###25303111
BACKGROUND	Childbirth fear is associated with increased obstetric interventions and poor emotional and psychological health for women .
BACKGROUND	The purpose of this study is to test an antenatal psycho-education intervention by midwives in reducing women 's childbirth fear .
METHODS	Women ( n = 1,410 ) attending three hospitals in South East Queensland , Australia , were recruited into the BELIEF trial .
METHODS	Participants reporting high fear were randomly allocated to intervention ( n = 170 ) or control ( n = 169 ) groups .
METHODS	All women received a decision-aid booklet on childbirth choices .
METHODS	The telephone counseling intervention was offered at 24 and 34 weeks of pregnancy .
METHODS	The control group received usual care offered by public maternity services .
METHODS	Primary outcome was reduction in childbirth fear ( WDEQ-A ) from second trimester to 36 weeks ' gestation .
METHODS	Secondary outcomes were improved childbirth self-efficacy , and reduced decisional conflict and depressive symptoms .
METHODS	Demographic , obstetric & psychometric measures were administered at recruitment , and 36 weeks of pregnancy .
RESULTS	There were significant differences between groups on postintervention scores for fear of birth ( p < 0.001 ) and childbirth self-efficacy ( p = 0.002 ) .
RESULTS	Decisional conflict and depressive symptoms reduced but were not significant .
CONCLUSIONS	Psycho-education by trained midwives was effective in reducing high childbirth fear levels and increasing childbirth confidence in pregnant women .
CONCLUSIONS	Improving antenatal emotional well-being may have wider positive social and maternity care implications for optimal childbirth experiences .

###25256258
BACKGROUND	Abediterol ( LAS100977 ) is a novel , long-acting 2-agonist , in development for the once-daily treatment of asthma in combination with mometasone .
BACKGROUND	Here we report the results of a Phase IIa trial of single doses of abediterol added to ongoing maintenance therapy ( inhaled corticosteroids ) in patients with persistent mild-to-moderate asthma .
METHODS	This was a randomised , double-blind , placebo - and active-comparator-controlled , five-way crossover study .
METHODS	Male patients ( 18-70 years ) with a clinical diagnosis of persistent asthma received abediterol ( 5 , 10 and 25g ) , salmeterol and placebo , on top of ongoing maintenance therapy .
METHODS	Lung function was determined using spirometry and whole body plethysmography .
METHODS	The primary efficacy endpoint was change from baseline in trough forced expiratory volume in 1s ( FEV1 ) after a single dose .
RESULTS	All three abediterol doses induced statistically significant increases in trough FEV1 vs placebo and salmeterol .
RESULTS	Improvements in other lung function parameters were also statistically significantly greater with all abediterol doses vs both placebo ( p < 0.0001 ) and salmeterol ( p < 0.05 ) than the first assessment at 5min post-dose .
RESULTS	These improvements were sustained to 36h post-dose .
RESULTS	The profile of treatment-emergent adverse events judged as related to abediterol was consistent with that seen after adrenergic stimulation and occurred exclusively in patients who received abediterol 10g or 25g .
CONCLUSIONS	This first-in-patient study revealed the potent , rapid and long-acting bronchodilatory effect of abediterol in patients with persistent mild-to-moderate asthma together with an overall good safety and tolerability profile .
CONCLUSIONS	Further studies are now underway to establish the optimal efficacy-safety-tolerability profile for this compound .

###25636288
OBJECTIVE	To evaluate the efficacy of 2 mandibular advancement devices in 6-week treatment of patient with severe obstructive sleep apnea hypopnea syndrome ( OSAHS ) who refused to CPAP or CPAP therapy .
METHODS	A randomized cross-over study was designed and conducted .
METHODS	Twenty-two male patients with severe OSAHS were included for treatment .
METHODS	Rod type and controllable type mandibular advancement devices ( MADs ) were used respectively in 6 weeks with 2-week interval , while the whole experimental duration was 14 weeks .
METHODS	The differences of the indexes of the polysomnography ( PSG ) were analyzed , which were gained before the intervention and 6 weeks after use of 2 types of MADs .
METHODS	Questionnaires with Epworth sleep and SCL-90 symptoms self evaluation scales were proceeded .
METHODS	Meanwhile , the parameters such as the stability of the MAD , the adverse reaction and the subjective symptom relief were assessed .
METHODS	The result was statistically analyzed by SPSS19 .0 software package .
RESULTS	Compared with the apnea hypopnea index ( AHI ) before the intervention ( 48.1613.99 times/hr ) , both the AHI of the rod type ( 19.162.74 times/hr ) and the controllable type ( 18.932.57 times/hr ) were reduced by 50 % .
RESULTS	The remaining parameters showed that both types of MADs had a significant effect on mandibular advancement .
RESULTS	There was significant different decrease in each index of the SCL-90 ( P < 0.01 ) , while significant differences were found in somatization , interpersonal sensitivity and anxiety compared with those before intervention ( P < 0.05 ) .
RESULTS	At the same time , there were significant differences in the indexes of stability and results occlusive comfort between the rod type and the controllable MADs ( P < 0.05 ) .
CONCLUSIONS	The objective results and the patients ' physical and mental health are improved obviously by using the 2 types of MADs .
CONCLUSIONS	Controllable MADs have more advantages in compliance ; however , further research should be conducted for long-time outcome .

###24821594
OBJECTIVE	To identify the pyrazinamide MIC above which standard combination therapy fails .
METHODS	MICs of pyrazinamide were determined for Mycobacterium tuberculosis isolates , cultured from 58 patients in a previous randomized clinical trial in Cape Town , South Africa .
METHODS	The MICs were determined using BACTEC MGIT 960 for isolates that were collected before standard treatment with isoniazid , rifampicin , pyrazinamide and ethambutol commenced .
METHODS	Weekly sputum collections were subsequently made for 8 weeks in order to culture M. tuberculosis in Middlebrook broth medium .
METHODS	Classification and regression tree ( CART ) analysis was utilized to identify the pyrazinamide MIC predictive of sputum culture results at the end of pyrazinamide therapy .
METHODS	The machine learning-derived susceptibility breakpoints were then confirmed using standard association statistics that took into account confounders of 2 month sputum conversion .
RESULTS	The pyrazinamide MIC range was 12.5 to > 100 mg/L for the isolates prior to therapy .
RESULTS	The epidemiological 95 % cut-off value was > 100 mg/L .
RESULTS	The 2 month sputum conversion rate in liquid cultures was 26 % by stringent criteria and 48 % by less stringent criteria .
RESULTS	CART analysis identified an MIC breakpoint of 50 mg/L , above which patients had poor sputum conversion rates .
RESULTS	The relative risk of poor sputum conversion was 1.5 ( 95 % CI : 1.2-1 .8 ) for an MIC > 50 mg/L compared with an MIC 50 mg/L .
CONCLUSIONS	We propose a pyrazinamide susceptibility breakpoint of 50 mg/L for clinical decision making and for development of rapid susceptibility assays .
CONCLUSIONS	This breakpoint is identical to that identified using computer-aided simulations of hollow fibre system output .

###24809397
BACKGROUND	Psychoeducation programmes for people with schizophrenia are shown to reduce relapses but few studies have indicated significant improvements in patients ' illness awareness and insight , functioning , symptom severity or rates of readmission to hospital .
OBJECTIVE	To examine the effects of a mindfulness-based psychoeducation programme for Chinese people with schizophrenia .
METHODS	A multisite randomised controlled trial was conducted with 107 out-patients with schizophrenia : 36 and 35 received a 6-month mindfulness-based psychoeducation and a conventional psychoeducation programme , respectively , and 35 received routine care alone .
METHODS	Patient outcome measures were psychiatric symptom severity , psychosocial functioning , social support , insight into illness/treatment , and frequency and duration of readmissions to hospital ( ClinicalTrials.gov : trial registration NCT01667601 ) .
RESULTS	The mindfulness-based psychoeducation group reported significantly greater improvements in psychiatric symptoms , psychosocial functioning , insight into illness/treatment and duration of readmissions to hospital over 24 months when compared with the other two groups .
CONCLUSIONS	Mindfulness-based psychoeducation appears to be a promising approach to treatment for Chinese patients with schizophrenia .

###25473190
OBJECTIVE	To investigate the optimum period of treatment for post endoscopic submucosal dissection ( ESD ) ulcers .
METHODS	Patients who underwent ESD for gastric cancer were randomized to two groups and treated with esomeprazole 20 mg per day for 4 wk ( 4W group ) or 2 wk ( 2W group ) .
METHODS	At 4 wk after ESD , we measured the size of the artificial ulcers by endoscopy and determined the ulcer healing rate , compared with the size of the ESD specimens .
METHODS	This randomized controlled trial study was approved by our ethics committee and registered in the UMIN Clinical Trial Registry .
RESULTS	A total of 60 consecutive patients were included in the study .
RESULTS	All patients received rebamipide 300 mg per day for 4 wk .
RESULTS	One patient in 2W group who showed bleeding within two weeks and received endoscopic treatment was excluded from further analysis .
RESULTS	The numbers of patients with ulcers in the healing/scar stage in the 2W and 4W groups at 4 wk after ESD were 20/6 and 28/5 , respectively , with no significant difference .
RESULTS	The ulcer healing rate in the 2W and 4W groups were 96.1 % [ 95 % confidence interval ( CI ) : 94.6 % -97.55 ] vs 94.8 % ( 95 % CI : 92.6 % -97.1 % ) , respectively , with no statistical difference ( UMIN000006951 ) .
CONCLUSIONS	Two-wk treatment with a proton pump inhibitor is as effective as four-week treatment for healing post ESD ulcers .

###25240072
BACKGROUND	The contribution of sweet beverages to weight gain in children is controversial ; the impact of these beverages on caloric adjustment needs clarification .
OBJECTIVE	We studied the influence of energy-density ( ED ) conditioning on the liking for sweet beverages and caloric adjustment after their consumption in children .
METHODS	We used a within-subject design .
METHODS	Forty-four 8-11-y-old children were exposed to the following 2 distinctly flavored , sweetened beverages : a high-energy ( HE ) version ( 150 kcal ) and a no-energy ( NE ) version ( 0 kcal ) .
METHODS	During a 4-wk initial conditioning period , children were exposed either 2 or 7 times to each beverage .
METHODS	After a 3-wk stability period ( without exposure ) , children were exposed 3 times to both beverages with a reversed association between the ED and flavor ( 4-wk reversed-conditioning period ) .
METHODS	Flavor liking and food intake during meals after the consumption of each beverage were assessed before and after each period .
RESULTS	After the initial conditioning , the liking for both beverages increased ( P < 0.001 ) .
RESULTS	After the stability period , the liking for the HE flavor was higher than for the NE flavor ( P = 0.024 ) .
RESULTS	After the reversed conditioning , the liking for the flavor initially paired with the HE beverage tended to remain higher than for the NE flavor ( P = 0.089 ) .
RESULTS	Initially , energy intakes during the meal did not differ after the consumption of NE or HE beverages .
RESULTS	After the initial conditioning and up until the end of the reversed conditioning , energy intakes were lower after the HE beverage than after the NE beverage regardless of the beverage flavor ( eg , after reversal ; caloric compensation score : 29 % ) .
RESULTS	The number of exposures did not influence liking or energy intake .
CONCLUSIONS	After the association between a flavor and ED and reversal of this association , liking may be first guided by ED and then the flavor firstly associated with ED , whereas the partial caloric compensation may consistently be guided by ED .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT02070185 .

###25365723
OBJECTIVE	To investigate the hemodynamic profile associated with different target temperatures and to assess the prognostic implication of inotropic/vasopressor support and mean arterial pressure after out-of-hospital cardiac arrest .
OBJECTIVE	There is a lack of information how different target temperatures may affect hemodynamics .
METHODS	Post hoc analysis of a prospective randomized study .
METHODS	Thirty-six ICUs in 10 countries .
METHODS	Nine hundred twenty patients ( 97 % ) with available vasopressor data out of 950 patients from the Target Temperature Management trial randomly assigned patients to a targeted temperature management at 33 C or 36 C.
METHODS	None .
RESULTS	Mean arterial pressure , heart rate , and lactate were registered at prespecified time points .
RESULTS	The population was stratified according to cardiovascular Sequential Organ Failure Assessment = 4 defining the high vasopressor group and cardiovascular Sequential Organ Failure Assessment less than or equal to 3 defining the low vasopressor group .
RESULTS	The targeted temperature management 33 ( TTM33 ) group had a hemodynamic profile with lower heart rate ( -7.0 min ( -1 ) [ 95 % confidence limit , -8.7 , -5.1 ] ; p ( group ) < 0.0001 ) , similar mean arterial pressure ( -1.1 mm Hg [ 95 % confidence limit , -2.3 , 0.2 ] ; p ( group ) = 0.10 ) , and increased lactate ( 0.6 mmol/L [ 95 % confidence limit , 0.3 , 0.8 ] ; p ( group ) < 0.0001 ) compared with the targeted temperature management 36 ( TTM36 ) group .
RESULTS	A cardiovascular Sequential Organ Failure Assessment score = 4 was recorded in 54 % versus 45 % , p = 0.03 in the TTM33 and the TTM36 group , respectively .
RESULTS	The high vasopressor group carried a 53 % mortality rate when compared with a 34 % in the low vasopressor group , p ( log-rank ) less than 0.0001 , with an adjusted hazard ratio of 1.38 ( 95 % CI , 1.11-1 .71 ; p = 0.004 ) .
RESULTS	There was no interaction between vasopressor group and allocated target temperature group ( p = 0.40 ) .
RESULTS	An inverse relationship between mean arterial pressure and mortality was identified ( p = 0.0008 ) .
CONCLUSIONS	Targeted temperature management at 33 C was associated with hemodynamic alterations with decreased heart rate , elevated levels of lactate , and need for increased vasopressor support compared with targeted temperature management at 36 C. Low mean arterial pressure and need for high doses of vasopressors were associated with increased mortality independent of allocated targeted temperature management .

###24451146
BACKGROUND	Osteopontin ( OPN ) is a malignancy-associated glycoprotein that contributes functionally to tumor aggressiveness .
BACKGROUND	In metastatic breast cancer , we previously demonstrated that elevated OPN in primary tumor and blood was associated with poor prognosis .
METHODS	We measured OPN in plasma by ELISA , and in tumors by immunohistochemistry , in 624 ( 94 % ) and 462 ( 69 % ) , respectively , of 667 postmenopausal women with hormone responsive early breast cancer treated by surgery followed by adjuvant treatment with tamoxifen + / - octreotide in a randomized trial ( NCIC CTG MA .14 ; National Cancer Institute of Canada Clinical Trials Group Mammary .14 ) .
RESULTS	Plasma OPN was measured in 2,540 samples ; 688 at baseline and 1,852 collected during follow-up .
RESULTS	Mean baseline plasma OPN was 46ng/ml ( range 22.6 to 290 ) which did not differ from normal levels .
RESULTS	Mean percentage OPN tumor cell positivity was 33.9 ( 95 % CI : 30.2 to 37.9 ) .
RESULTS	There was no correlation between plasma and tumor OPN values .
RESULTS	In multivariate analysis , neither was associated with event-free survival ( EFS ) , relapse-free survival ( RFS ) , overall survival ( OS ) , bone RFS or non-bone RFS .
RESULTS	An exploratory analysis in patients with recurrence showed higher mean OPN plasma levels 60.7 ng/ml ( 23.9 to 543 ) in the recurrence period compared with baseline levels .
CONCLUSIONS	The hypothesis that OPN tumor expression would have independent prognostic value in early breast cancer was not supported by multivariate analysis of this study population .
CONCLUSIONS	Plasma OPN levels in women with hormone responsive early breast cancer in the MA .14 trial were not elevated and there was no evidence for prognostic value of plasma OPN in this defined group of patients .
CONCLUSIONS	However , our finding of elevated mean OPN plasma level around the time of recurrence warrants further study .
BACKGROUND	NCT00002864 , http://clinicaltrials.gov/show/NCT00002864 .

###25230995
BACKGROUND	Children who experience neglect and abuse are likely to have impaired brain development and entrenched learning deficiencies .
BACKGROUND	Early years interventions such as intensive education and care for these children are known to have the potential to increase their human capital .
BACKGROUND	The Early Years Education Program ( EYEP ) is a new program offered by the Children 's Protection Society ( CPS ) in Melbourne , Australia .
BACKGROUND	EYEP is targeted at the needs of children who have been or are at risk of being abused or neglected .
BACKGROUND	It has the dual focus of seeking to address the consequences of abuse and neglect on children 's brain development and redressing their learning deficiencies .
BACKGROUND	Our objective is to determine whether EYEP can improve school readiness by conducting a randomised controlled trial ( RCT ) of its impacts .
METHODS	The RCT is being conducted with 90 participants ( 45 intervention and 45 control ) .
METHODS	Eligible children must be aged under three years and assessed as having two or more risk factors as defined in the Department of Human Services Best Interest Case Practice Model .
METHODS	The intervention group participate for three years ( or until school entry ) in EYEP .
METHODS	The trial does not provide any early years education or care to the control group .
METHODS	Data are being collected on outcome measures for participants in EYEP and the control group at the baseline , at yearly intervals for three years , and six months after commencing the first year of school .
METHODS	Outcome measures encompass children 's health and development , academic ability and emotional and behavioural regulation ; and quality of parenting practices .
METHODS	The study will evaluate the impact of EYEP on these outcomes , and undertake a benefit-cost analysis of the program .
CONCLUSIONS	Findings from the study have the potential to influence the quality of care and education for the large population of children in Australia who are at risk of abuse and neglect , as well as for children in mainstream childcare .
CONCLUSIONS	The study will provide up-to-date evidence on the impact of an early years intervention relevant to an urban population in Australia ; as well as ( to our knowledge ) being the first RCT of an early years education and care intervention in Australia .
BACKGROUND	ACTRN 12611000768998 .
BACKGROUND	Date 22nd July 2011 .

###25495859
OBJECTIVE	To assess sustained siphon filter usage among a low-income population in Bangladesh and study relevant motivators and barriers .
METHODS	After a randomised control trial in Bangladesh during 2009 , 191 households received a siphon water filter along with educational messages .
METHODS	Researchers revisited households after 3 and 6months to assess filter usage and determine relevant motivators and barriers .
METHODS	Regular users were defined as those who reported using the filter most of the time and were observed to be using the filter at follow-up visits .
METHODS	Integrated behavioural model for water , sanitation and hygiene ( IBM-WASH ) was used to explain factors associated with regular filter use .
RESULTS	Regular filter usage was 28 % at the 3-month follow-up and 21 % at the 6-month follow-up .
RESULTS	Regular filter users had better quality water at the 6-month , but not at the 3-month visit .
RESULTS	Positive predictors of regular filter usage explained through IBM-WASH at both times were willingness to pay > US$ 1 for filters , and positive attitude towards filter use ( technology dimension at individual level ) ; reporting boiling drinking water at baseline ( psychosocial dimension at habitual level ) ; and Bengali ethnicity ( contextual dimension at individual level ) .
RESULTS	Frequently reported barriers to regular filter use were as follows : considering filter use an additional task , filter breakage and time required for water filtering ( technology dimension at individual level ) .
CONCLUSIONS	The technological , psychosocial and contextual dimensions of IBM-WASH contributed to understanding the factors related to sustained use of siphon filter .
CONCLUSIONS	Given the low regular usage rate and the hardware-related problems reported , the contribution of siphon filters to improving water quality in low-income urban communities in Bangladesh is likely to be minimal .

###25302927
OBJECTIVE	The objective of the study was to investigate the effects of a galacto-oligosaccharides ( GOS ) - supplemented formula on the intestinal microbiota in healthy term infants , with a specific consideration for gastrointestinal symptoms as colic , stool frequency and consistency , regurgitation .
METHODS	This was a randomized , double-blind , controlled , parallel-group clinical trial performed simultaneously by 6 centers in Italy .
METHODS	Three groups were considered : breastfed , formula-fed , and GOS-supplemented formula-fed infants .
METHODS	Formula-fed infants were randomized to receive either the control or the study formula and consume the assigned formula exclusively until the introduction of complementary feeding .
METHODS	The nutritional composition of the 2 formulas were identical , apart from the supplemented GOS ( 0.4 g/100mL ) in the study formula .
METHODS	Four different types of bacteria were evaluated in order to assess the efficacy of GOS-supplemented formula on infants : Bifidobacterium , Lactobacillus , and Clostridium , Escherichia coli .
RESULTS	A total of 199 breastfed infants and 163 formula-fed infants were recruited .
RESULTS	When considering stool frequency and consistency , GOS-supplemented formula presented normal and soft stools in the majority of episodes ( 89 % ) .
RESULTS	In the supplemented group the incidence of colic was lower with respect to the control group .
RESULTS	A significantly lower count of Clostridium and a higher count of Bifidobacterium were found when comparing study formula and control formula in infants with colic .
RESULTS	In children with colic the ratio between Clostridium count and Bifidobacterium and Lactobacillus count was in favor of the latter two when considering the GOS-supplemented formula group with respect to the control one .
CONCLUSIONS	The prebiotic-supplemented formula mimicked the effect of human milk in promoting Bifidobacterium and Lactobacillus growth and in inhibiting Clostridium growth , resulting in a significantly lower presence of colic .

###25582578
BACKGROUND	The relapse rate of ulcerative colitis ( UC ) is high .
BACKGROUND	The efficacy of combined diosmectite and mesalazine treatment for active mild-to-moderate UC was investigated .
METHODS	A total of 120 patients with UC were enrolled in this randomized , single-blind , placebo-controlled study .
METHODS	Sixty patients were assigned to the Diosmectite group ( diosmectite and mesalazine ) and 60 were assigned to Placebo group ( placebo and mesalazine ) .
METHODS	In the induction phase , the primary end point was the clinical remission rate at 8 weeks ; secondary end points were clinical response , endothelial mucosal healing , Mayo score , erythrocyte sedimentation rate , C-reactive protein levels , and defecation frequency .
METHODS	In the maintenance phase , the primary end point was clinical remission at 52 weeks ; secondary end points were clinical response , endothelial mucosal healing , Mayo score , erythrocyte sedimentation rate , and defecation frequency .
RESULTS	At 8 weeks , the Diosmectite group had a significantly higher clinical remission rate ( 68.3 % vs. 50 % ) and mucosal healing rate ( 66.7 % vs. 48.3 % ) compared with the Placebo group .
RESULTS	There were no significant differences in clinical response rates , Mayo score , erythrocyte sedimentation rate , C-reactive protein , or defecation frequency .
RESULTS	At 52 weeks , the Diosmectite group had a significantly higher clinical remission rate ( 61.7 % vs. 40 % ) and mucosal healing rate ( 60 % vs. 38.3 % ) compared with the Placebo group .
RESULTS	Defecation frequency was lower , but this was not significant .
CONCLUSIONS	Combined diosmectite and mesalazine treatment successfully induced and maintained the treatment of active mild-to-moderate UC as indicated by higher rates of clinical remission and mucosal healing .

###24353120
OBJECTIVE	It is commonly assumed that ablation of any remaining Barrett 's epithelium after endoscopic resection of early Barrett 's neoplasia improves outcome by reducing the rate of metachronous lesions , but this has not yet been evaluated in a randomized trial .
OBJECTIVE	The aim of this study was to compare argon plasma coagulation ( APC ) with surveillance only for the management of residual Barrett 's epithelium following endoscopic resection .
METHODS	Patients in whom focal early Barrett 's neoplasia ( high grade intraepithelial neoplasia [ HGIN ] or mucosal cancer ) had been curatively resected by endoscopy were randomly assigned to undergo ablation of the residual Barrett 's segment by APC or surveillance only ; pH-metry-adjusted proton pump inhibitor therapy was administered in both groups .
METHODS	The main outcome parameter was recurrence-free survival .
METHODS	Follow-up endoscopies with biopsies in cases of further residual Barrett 's epithelium were carried out at 6-monthly intervals in both groups .
RESULTS	A total of 63 patients ( 57 male [ 90.5 % ] ) were included in the study ( ablation group n = 33 ; surveillance group n = 30 ) .
RESULTS	For complete Barrett 's ablation , a mean number of 41.6 APC sessions were required ( range 2-7 ) .
RESULTS	The mean follow-up duration did not differ significantly between ablation ( 28.213.7 months , range 0-44 ) and surveillance patients ( 24.714.8 months , range 0-45 ; P = 0.159 ) .
RESULTS	The number of secondary lesions was 1 in the ablation group ( 3 % ) , and 11 in the surveillance group ( 36.7 % ) , leading to significantly higher recurrence-free survival for the patients undergoing ablation ( P = 0.005 ) .
CONCLUSIONS	Thermal ablation of residual Barrett 's epithelium leads to a significant reduction in neoplasia recurrence rate compared with a surveillance strategy during a limited follow-up of 2 years .
CONCLUSIONS	A longer follow-up duration may have led to a relatively higher rate of secondary neoplasia in both groups of patients .

###24535014
OBJECTIVE	Imbalance between work demands and individual resources can lead to musculoskeletal disorders and reduced work ability .
OBJECTIVE	The aim of this study was to evaluate the effect of two contrasting interventions on work ability among slaughterhouse workers with chronic pain and work disability .
METHODS	Sixty-six slaughterhouse workers with upper-limb chronic pain and work disability were randomly allocated to 10 weeks of either strength training for the shoulder , arm , and hand muscles ( 3 times per week , 10 minutes per session ) or ergonomic training ( usual care control group ) from September to December 2012 .
METHODS	The outcome measure was the change from baseline to 10-week follow-up in the work ability index ( WAI ) .
RESULTS	A priori hypothesis testing showed a grouptime interaction for WAI ( P < 0.05 ) .
RESULTS	Compared with the ergonomic training group , WAI increased 2.3 [ 95 % confidence interval ( 95 % CI ) 0.9-3 .7 ] in the strength training group corresponding to a moderate effect size ( Cohen 's d 0.52 ) .
RESULTS	Within-group changes indicated that between-group differences were mainly caused by a reduction in WAI in the ergonomic group .
RESULTS	Of the 7 items of WAI , item 2 ( work ability in relation to the demands of the job ) and item 7 ( mental resources ) increased following strength training compared with ergonomic training ( P < 0.05 ) .
CONCLUSIONS	Implementation of strength training at the workplace prevents deterioration of work ability among manual workers with chronic pain and disability exposed to forceful and repetitive job tasks .
CONCLUSIONS	Thus , strength training performed at the workplace may in fact be regarded as a complex biopsychosocial intervention modality that reaches further than the specific physiological benefits of training per se .

###24560188
BACKGROUND	Obstructive sleep apnea ( OSA ) is a chronic progressive disease , and it is well-documented that severe OSA is associated with an increased cardiovascular morbidity and mortality .
BACKGROUND	Weight reduction has been shown to improve OSA ; however , we need further evidence to determine if it may prevent the progression of OSA in the long term .
BACKGROUND	The aim of our study was to assess the impact of weight change during a 5-year observational follow-up of an original 1-year randomized controlled trial .
METHODS	The participants were divided into the two groups according to the weight change at 5-year follow-up using the 5 % weight loss as a cutoff point , which was later referred to as the successful ( n = 20 ) or unsuccessful groups ( n = 27 ) .
METHODS	The change in apnea-hypopnea index ( AHI ) was the main objective outcome variable .
RESULTS	Fifty-seven patients participated in the 5-year follow-up .
RESULTS	At 5 years from the baseline , the change in AHI between the groups was significant in the successful group ( -3.5 [ 95 % confidence interval { CI } , -6.1 to -0.9 ] ) compared with the unsuccessful group ( 5.0 [ 95 % CI , 2.0-8 .5 ] ) ( P = .002 ) .
RESULTS	Successful weight reduction achieved an 80 % reduction in the incidence of progression of OSA compared to the unsuccessful group ( log-rank test , P = .016 ) .
CONCLUSIONS	A moderate but sustained weight reduction can prevent the progression of the disease or even cure mild OSA in obese patients .

###24811331
BACKGROUND	Sleep-disordered breathing may impair cerebral oxygenation in patients with OSA syndrome , in particular during altitude travel .
BACKGROUND	We studied cerebral tissue oxygenation ( CTO ) at low and moderate altitude in patients with OSA and evaluated whether acetazolamide improved CTO .
METHODS	Eighteen patients with OSA living at < 600 m discontinued CPAP therapy during studies in Zurich ( 490 m ) and during two sojourns of 3 days in the Swiss Alps ( 2 days at 1,860 m and 1 day at 2,590 m ) separated by a 2-week washout period at < 600 m. Patients received acetazolamide ( 2 250 mg/d ) or placebo at altitude in a randomized , double-blind , crossover design .
METHODS	Nocturnal polysomnography , including CTO monitoring by near-infrared spectroscopy ( NIRS ) , was performed .
RESULTS	At 490 m , medians of CTO , peripheral oxygen saturation as measured by pulse oximetry ( Spo2 ) , and apnea/hypopnea index were 65 % , 93 % , and 57.3 / h , respectively .
RESULTS	At 2,590 m , on placebo , the corresponding values were 59 % , 86 % , and 86.4 / h , respectively ( P < .05 , all corresponding comparisons ) .
RESULTS	Acetazolamide increased CTO and Spo2 at 2,590 m by mean values of 2 % ( 95 % CI , 0 % -4 % ) and 2 % ( 95 % CI , 1 % -3 % ) , respectively , and reduced the apnea/hypopnea index by 23.4 / h ( 95 % CI , 14.0-32 .8 / h ) ( P < .05 , all changes ) .
RESULTS	Cerebral total hemoglobin concentration , a NIRS-derived surrogate reflecting regional cerebral blood volume , increased by a similar degree in response to apneas at 490 m and 2,590 m and during acetazolamide and placebo treatment .
CONCLUSIONS	In patients with OSA staying at altitude , nocturnal cerebral and arterial oxygenation were reduced in association with exacerbated sleep apnea .
CONCLUSIONS	Acetazolamide partially improved CTO , Spo2 , and sleep apnea without impairing the cerebral blood flow response to apneas .
BACKGROUND	ClinicalTrials.gov ; No. : NCT00714740 ; URL : www.clinicaltrials.gov .

###24950745
OBJECTIVE	Controlled hypotension ( CH ) is a well-established technique to decrease blood loss and improve surgical visibility .
OBJECTIVE	Although nitroprusside and remifentanil have been safely and effectively used for this purpose , the hemodynamic changes that occur during CH are unclear .
OBJECTIVE	This study compared the effects of nitroprusside and remifentanil on hemodynamics using a noninvasive cardiac output monitor ( Cheetah NICOM ( ) ; Cheetah Medical Inc. , Maidenhead , Berkshire , UK ) for endoscopic sinus surgery ( ESS ) .
METHODS	Twenty-eight adult patients scheduled for ESS were randomly assigned to the nitroprusside group ( n = 14 ) or remifentanil group ( n = 14 ) .
METHODS	After anesthesia induction , hypotension was induced with continuous infusion of nitroprusside or remifentanil at a target mean arterial blood pressure ( MAP ) of 60-70 mmHg .
METHODS	Cardiac index ( CI ) , stroke volume index ( SVI ) and total peripheral resistance index ( TPRI ) were measured at 10-min intervals .
RESULTS	The heart rate was higher and SVI was lower in the nitroprusside group than in the remifentanil group during CH .
RESULTS	There were no significant differences in MAP , CI or TPRI between the two groups .
RESULTS	Both nitroprusside and remifentanil reduced MAP and TPRI during CH compared with baseline values .
RESULTS	However , there was no significant change in CI .
CONCLUSIONS	Both nitroprusside and remifentanil were effective to induce CH and maintain CI during CH .

###25686680
OBJECTIVE	HIV-infected participants are at a higher risk for cardiovascular disease ( CVD ) .
OBJECTIVE	N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) is a significant predictor of CVD in the general population and is associated with mortality in HIV .
METHODS	The 96-week Stopping Atherosclerosis and Treating Unhealthy Bone with Rosuvastatin in HIV ( SATURN-HIV ) trial randomized 147 patients on stable antiretroviral therapy with low-density lipoprotein-cholesterol level lower than 130mg/dl and without overt heart failure to 10mg daily rosuvastatin or placebo .
METHODS	We measured NT-proBNP levels by enzyme-linked immunosorbent assay ( ELISA ) .
METHODS	Baseline and changes in NT-proBNP were compared between groups .
METHODS	Spearman correlation was used to explore relationships between baseline NT-proBNP , inflammation , and CVD risk markers .
METHODS	Multivariable analyses were conducted to assess associations with NT-proBNP levels .
RESULTS	Median age was 46 years , 80 % were men , 69 % were African American , and 46 % were on protease inhibitors .
RESULTS	At baseline , median ( Q1 , Q3 ) NT-proBNP was higher in the rosuvastatin group than placebo [ 41 ( 20 , 66.5 ) versus 25pg/ml ( 11 , 56 ) , P = 0.012 ) ] .
RESULTS	Baseline NT-proBNP correlated with bulb and common carotid artery intima-media thickness , coronary calcium score , interleukin 6 , and cystatin C.
RESULTS	After 96 weeks , median NT-proBNP decreased significantly in the rosuvastatin group versus placebo ( -1.50 versus +4.50 pg/ml , P = 0.041 ) .
RESULTS	Within the rosuvastatin group , changes in NT-proBNP were negatively correlated with changes in insulin resistance and total limb fat .
CONCLUSIONS	Rosuvastatin reduces plasma NT-proBNP in HIV-infected participants on antiretroviral therapy .
CONCLUSIONS	NT-proBNP correlated with several measures of CVD risk , independent of inflammation markers .

###24263695
OBJECTIVE	Acute intracranial hemorrhage represents a severe and time critical pathology that requires precise and quick diagnosis , mainly by performing a CT scan .
OBJECTIVE	The purpose of this study was to compare image quality and intracranial hemorrhage conspicuity in brain CT with sinogram-affirmed iterative reconstruction and filtered back-projection reconstruction techniques at standard ( 340 mAs ) and low-dose tube current levels ( 260 mAs ) .
METHODS	A total of 94 consecutive patients with intracranial hemorrhage received CT scans either with standard or low-dose protocol by random assignment .
METHODS	Group 1 ( n = 54 ; mean age , 64 20 years ) received CT at 340 mAs , and group 2 ( n = 40 ; mean age , 57 23 years ) received CT at 260 mAs .
METHODS	Images of both groups were reconstructed with filtered back-projection reconstruction and 5 iterative strengths ( S1-S5 ) and ranked blind by 2 radiologists for image quality and intracranial hemorrhage on a 5-point scale .
METHODS	Image noise , SNR , dose-length product ( mGycm ) , and mean effective dose ( mSv ) were calculated .
RESULTS	In both groups , image quality and intracranial hemorrhage conspicuity were rated subjectively with an excellent/good image quality .
RESULTS	A higher strength of sinogram-affirmed iterative reconstruction showed an increase in image quality with a difference to filtered back-projection reconstruction ( P < .05 ) .
RESULTS	Subjective rating showed the best score of image quality and intracranial hemorrhage conspicuity achieved through S3/S4 -5 .
RESULTS	Objective analysis of image quality showed in an increase of SNR with a higher strength of sinogram-affirmed iterative reconstruction .
RESULTS	Patients in group 2 ( mean : 744 mGycm/1 .71 mSv ) were exposed to a significantly lower dose than those in group 1 ( mean : 1045 mGycm/2 .40 mSv , P < .01 ) .
CONCLUSIONS	S3 provides better image quality and visualization of intracranial hemorrhage in brain CT at 260 mAs .
CONCLUSIONS	Dose reduction by almost one-third is possible without significant loss in diagnostic quality .

###25385061
OBJECTIVE	To compare the anti-inflammatory efficacy of ketorolac of tromethamine 0.4 % and nepafenac 0.1 % eye drops for prophylaxis of cystoid macular oedema ( CME ) after small-incision cataract extraction .
METHODS	Patients were assigned randomly to three groups .
METHODS	Group 1 patients received a topical artificial tear substitute ( placebo ) ; group 2 received ketorolac tromethamine 0.4 % ( Acular LS , Allergan ) and group 3 received nepafenac 0.1 % ( Nevanac , Alcon ) .
METHODS	The incidence and severity of CME were evaluated by retinal foveal thickness on optical coherence tomography ( OCT ) after 1 , 4 and 12weeks .
RESULTS	One hundred and twenty-six eyes of 126 patients were included in this study .
RESULTS	The between-group differences in visual outcomes , central corneal thickness and endothelial cell density were not statistically significant .
RESULTS	In all retinal thickness measurements , an increase was detected starting from the postoperative first week until 12weeks .
RESULTS	There was no statistically significant difference between the three groups in any measurement performed by spectral-domain OCT. .
CONCLUSIONS	Used prophylactically after uneventful cataract surgery , non-steroidal anti-inflammatory drugs were not efficacious in preventing macular oedema compared with placebo .
BACKGROUND	ClinicalTrials : NCT02084576 .

###25906559
OBJECTIVE	To evaluate the clinical efficacy of electroacupuncture ( EA ) combined with transperineal injection of botulinum toxin-A ( BTX-A ) on neurogenic bladder caused by spinal cord injury .
METHODS	One day af ter surgery , 35 cases of spinal cord injury accompanied with neurogenic bladder were randomly divided into a BTX-A plus EA group ( 20 cases , group A ) and a BTX-A group ( 15 cases , group B ) .
METHODS	The two groups were both treated with regular rehabilitation training of bladder function and injection of 200 IU ( 4 ml ) BTX-A through perineum external urethral sphincter ; the group A was additionally treated with EA at Zhongji ( CV 3 ) , Guanyuan ( CV 4 ) , Shenshu ( 3BL 23 ) , Huiyang ( BL 35 ) and Baliao ( Shangliao ( BL 31 ) , Ciliao ( BL 32 ) , Zhongliao ( BL 33 ) , Xialiao ( BL 34 ) ) , once a day , 40 min per treatment .
METHODS	The treatment was given 6 times per week for 4 weeks .
METHODS	The urination status in two groups before and after treatment was observed , and urodynamics examination and urethral pressure test were also made .
RESULTS	After 4-week treatment , mean times of urinary incontinence , mean urethral catheter output , pressure of bladder and volume of urinary incontinence were all improved in two groups ( all P < 0.05 ) , which were more significant in the group A ( all P < 0.05 ) .
RESULTS	The residual urine , maximum bladder capacity , maximum urethral closure pressure and maximum urine flow rate were all improved in two groups after treatment ( all P < 0.01 ) ; the improvement of residual urine , maximum bladder capacity , maximum urethral closure pressure in the group A was more significant than that in the group B ( all P < 0.05 ) .
CONCLUSIONS	Electroacupuncture com bined with transperineal injection of BTX-A could effectively improve the urination dysfunction in patients with neurogenic bladder after spinal cord injury .

###25520427
BACKGROUND	The malaria-specific T-cell response is believed to be important for protective immunity .
BACKGROUND	Antimalarial chemoprevention may affect this response by altering exposure to malaria antigens .
METHODS	We performed interferon ( IFN ) ELISpot assays to assess the cellular immune response to blood-stage and pre-erythrocytic antigens longitudinally from 1 to 3 years of age in 196 children enrolled in a randomized trial of antimalarial chemoprevention in Tororo , Uganda , an area of high transmission intensity .
RESULTS	IFN responses to blood-stage antigens , particularly MSP1 , were frequently detected , strongly associated with recent malaria exposure , and lower in those adherent to chemoprevention compared to nonadherent children and those randomized to no chemoprevention .
RESULTS	IFN responses to pre-erythrocytic antigens were infrequent and similar between children randomized to chemoprevention or no chemoprevention .
RESULTS	Responses to blood-stage antigens were not associated with subsequent protection from malaria ( aHR 0.96 , P = .83 ) , but responses to pre-erythrocytic antigens were associated with protection after adjusting for prior malaria exposure ( aHR 0.52 , P = .009 ) .
CONCLUSIONS	In this high transmission setting , IFN responses to blood-stage antigens were common and associated with recent exposure to malaria but not protection from subsequent malaria .
CONCLUSIONS	Responses to pre-erythrocytic antigens were uncommon , not associated with exposure but were associated with protection from subsequent malaria .

###24809656
BACKGROUND	We studied the effects of different neuromuscular electrical stimulation ( NMES ) currents , 2 kHz-frequency alternating currents ( KACs , Russian and Aussie ) and 2 pulsed currents ( PCs ) , on isometric knee extension torque and discomfort level , both in isolation and combined , with maximum voluntary contraction ( MVC ) .
METHODS	Twenty-one women ( age 21.6 2.5 years ) were studied .
METHODS	We evaluated torque evoked by NMES or NMES combined with maximum voluntary contraction of the quadriceps muscle of healthy women .
METHODS	Discomfort level was measured using a visual analog pain scale .
RESULTS	Despite comparable levels of discomfort , evoked torque was lower for Russian current compared with the other modalities ( Russian 50.8 % , Aussie 71.7 % , PC500 76.9 % , and PC200 70.1 % ; P < 0.001 ) .
RESULTS	There was no advantage in combining NMES with MVC compared with isolated NMES .
CONCLUSIONS	The Aussie and PC approaches proved superior to Russian current for inducing isometric knee extension torque .
CONCLUSIONS	This information is important in guiding decision making with regard to NMES protocols for muscle strengthening .

###24552358
OBJECTIVE	To assess the superiority of fesoterodine 8 mg vs 4 mg for improvement in urgency urinary incontinence ( UUI ) episodes and other diary variables , diary-dry rate ( proportion of patients with > 0 UUI episodes on baseline diary and 0 UUI episodes on post-baseline diary ) , and improvements in measures of symptom bother , health-related quality of life ( HRQL ) , and other patient-reported outcomes ( PROs ) .
METHODS	This was a 12-week , randomised , double-blind , placebo-controlled , multinational trial of men and women aged 18 years with overactive bladder ( OAB ) symptoms including UUI ( ClinicalTrials.gov ID NCT01302067 ) .
METHODS	Patients were randomised ( 2:2:1 ) to receive fesoterodine 8 mg , fesoterodine 4 mg , or placebo once daily ; those randomised to fesoterodine 8 mg started with fesoterodine 4 mg once daily for 1 week , then 8 mg once daily for the remaining 11 weeks .
METHODS	Patients completed bladder diaries at baseline and weeks 4 and 12 and the Patient Perception of Bladder Condition ( PPBC ) , Urgency Perception Scale ( UPS ) , and Overactive Bladder Questionnaire ( OAB-q ) at baseline and week 12 .
METHODS	The primary endpoint was change from baseline to week 12 in UUI episodes per 24 h.
RESULTS	At week 12 , patients receiving fesoterodine 8 mg ( 779 patients ) had significantly greater reductions from baseline in UUI episodes , micturitions , and urgency episodes than patients receiving fesoterodine 4 mg ( 790 ) or placebo ( 386 ) ; diary-dry rate was significantly higher in the fesoterodine 8-mg group vs the fesoterodine 4-mg and placebo groups ( all P < 0.05 ) .
RESULTS	At week 12 , patients receiving fesoterodine 8 mg also had significantly greater improvements in scores on the PPBC , UPS , and all OAB-q scales and domains than patients receiving fesoterodine 4 mg or placebo ( all P < 0.01 ) .
RESULTS	Patients receiving fesoterodine 4 mg had significantly greater improvements in UUI episodes , urgency episodes , and micturitions ; significantly higher diary-dry rates ; and significantly greater improvement in PPBC scores and OAB-q scores than patients receiving placebo ( all P < 0.05 ) .
RESULTS	Dry mouth was the most commonly reported adverse event ( AE ) in the fesoterodine groups ( placebo group , 3.4 % ; fesoterodine 4-mg group , 12.9 % ; fesoterodine 8-mg group , 26.1 % ) ; most cases were mild or moderate in all treatment groups .
RESULTS	Rates of serious AEs and discontinuations due to AEs were low in all groups .
CONCLUSIONS	In a 12-week , prospectively designed , superiority trial , fesoterodine 8 mg showed statistically significantly superior efficacy vs fesoterodine 4 mg and placebo , as measured by reductions in UUI episodes and other diary variables , diary-dry dry rate , and improvements in measures of symptom bother , HRQL , and other PROs ; clear evidence of dose-dependent efficacy is unique to fesoterodine among antimuscarinics and other oral agents for the treatment of OAB .
CONCLUSIONS	Fesoterodine 4 mg was significantly more effective than placebo on all outcomes except for improvements in UPS scores .
CONCLUSIONS	These data support the benefit of having two doses of fesoterodine in clinical practice , with the recommended starting dose of 4 mg for all patients and the fesoterodine 8-mg dose available for patients who require a higher dose to achieve optimal symptom relief .

###25478740
OBJECTIVE	The purpose of this study was to develop and validate a computer-aided diagnosis ( CAD ) tool for automatic classification of pulmonary nodules seen on low-dose computed tomography into solid , part-solid , and non-solid .
METHODS	Study lesions were randomly selected from 2 sites participating in the Dutch-Belgian NELSON lung cancer screening trial .
METHODS	On the basis of the annotations made by the screening radiologists , 50 part-solid and 50 non-solid pulmonary nodules with a diameter between 5 and 30 mm were randomly selected from the 2 sites .
METHODS	For each unique nodule , 1 low-dose chest computed tomographic scan was randomly selected , in which the nodule was visible .
METHODS	In addition , 50 solid nodules in the same size range were randomly selected .
METHODS	A completely automatic 3-dimensional segmentation-based classification system was developed , which analyzes the pulmonary nodule , extracting intensity - , texture - , and segmentation-based features to perform a statistical classification .
METHODS	In addition to the nodule classification by the screening radiologists , an independent rating of all nodules by 3 experienced thoracic radiologists was performed .
METHODS	Performance of CAD was evaluated by comparing the agreement between CAD and human experts and among human experts using the Cohen statistics .
RESULTS	Pairwise agreement for the differentiation between solid , part-solid , and non-solid nodules between CAD and each of the human experts had a range between 0.54 and 0.72 .
RESULTS	The interobserver agreement among the human experts was in the same range ( range , 0.56-0 .81 ) .
CONCLUSIONS	A novel automated classification tool for pulmonary nodules achieved good agreement with the human experts , yielding values in the same range as the interobserver agreement .
CONCLUSIONS	Computer-aided diagnosis may aid radiologists in selecting the appropriate workup for pulmonary nodules .

###24300224
OBJECTIVE	We aimed to evaluate the effects of transcranial direct current stimulation ( tDCS ) on chronic pain in human T-lymphotropic virus type I-infected patients .
METHODS	This is a sham-controlled randomized clinical trial .
METHODS	Twenty participants were randomized to receive active or sham anodal tDCS over the primary motor cortex ( M1 ) , with 2 mA , 25 cm electrodes , for 20 minutes on 5 consecutive days .
METHODS	Pain intensity was measured at baseline and after each day of treatment using a Visual Analog Scale .
METHODS	Associated factors such as pain components description , pressure pain threshold , and Timed Up and Go task were also assessed .
RESULTS	Mild adverse events were reported by 100 % of patients in the tDCS group and 90 % in the sham group .
RESULTS	Comparison of daily Visual Analog Scale pain scores from both groups demonstrated a significant effect for the factor Time ( P < 0.001 ) , but not for Group ( P = 0.13 ) or TimeGroup interaction ( P = 0.06 ) .
RESULTS	There were 8 ( 80 % ) responders ( reduction of 50 % or more in pain intensity ) in the tDCS group and 3 ( 30 % ) in the sham group ( P = 0.03 ) .
RESULTS	Both groups demonstrated improvements for most associated factors evaluated .
RESULTS	However , there was no difference in between-groups comparison analyses .
CONCLUSIONS	The analysis of the main outcomes in this study did not demonstrate a significant advantage of anodal tDCS applied to M1 in patients with human T-lymphotropic virus type I and chronic pain in comparison with sham tDCS , although secondary analysis suggests some superiority of active tDCS over sham .
CONCLUSIONS	The large placebo effect observed in this study may explain the small differences between sham versus active tDCS .

###24718398
OBJECTIVE	Depression remains largely undiagnosed in women residing in rural India and consequently many do not seek help .
OBJECTIVE	Moreover , among those who are diagnosed , many do not complete treatment due to high rates of attrition .
OBJECTIVE	This study was aimed to compare the effectiveness of enhanced care with usual care in improving treatment seeking and adherence to antidepressant medication in women with depression living in rural India .
METHODS	Six villages from rural Bangalore were randomized to either community health worker supported enhanced care or usual care .
METHODS	A total of 260 adult depressed women formed the final participants for the analysis .
METHODS	The outcome measures were number of women who sought and completed treatment , number of clinic visits , duration of treatment with antidepressant , changes in severity of depression ( HDRS ) and changes in quality of life [ WHO-QOL ( Brev ) scale ] .
RESULTS	A significantly greater number of women from the treatment intervention ( TI ) group completed the treatment and were on treatment for a longer duration compared to the treatment as usual ( TAU ) group .
RESULTS	However , there were no significant differences in the severity of depression or quality of life between the TI and the TAU groups or between treatment completers and treatment dropouts at six months .
CONCLUSIONS	Enhanced care provided by the trained community health workers to rural women with major depression living in the community resulted in greater number of women seeking help and adhering to treatment with antidepressants .
CONCLUSIONS	However , despite enhanced care a significant number of rural women diagnosed with depression either did not seek help or discontinued treatment prematurely .
CONCLUSIONS	These findings have significant public health implications , as untreated depression is associated with considerable disability .

###25016922
BACKGROUND	Primary graft dysfunction ( PGD ) remains a significant problem after lung transplantation .
BACKGROUND	Data from animal and clinical studies suggest that remote ischemic conditioning ( RIC ) may reduce ischemia-reperfusion injury in solid organ transplantation .
METHODS	A pilot randomized controlled trial of 60 patients undergoing bilateral sequential lung transplantation assessed the utility of RIC in attenuating PGD .
METHODS	Treated recipients underwent 3 cycles of lower limb ischemic conditioning before allograft reperfusion .
METHODS	The primary outcome measure was a comparison of the partial pressure of arterial oxygen/fraction of inspired oxygen ratio ( P/F ratio ) between treatment groups .
RESULTS	No adverse effects of tourniquet application were observed .
RESULTS	The mean lowest P/F ratio during the first 24 hours after transplantation was 271.3 mm Hg in the treatment arm vs 256.1 mm Hg in the control arm ( p = 0.46 ) .
RESULTS	PGD grade and severity and the rate of acute rejection also showed a tendency to favor the treatment arm .
RESULTS	Sub-group analysis demonstrated a significant benefit of treatment in patients with a primary diagnosis of restrictive lung disease , a group at high risk for the development of PGD .
RESULTS	RIC was not accompanied by systemic release of high-molecular-weight group box 1 .
RESULTS	Levels of cytokines , high-molecular-weight group box 1 , and endogenous secretory receptor for advanced glycation end products peaked within 2 hours after reperfusion and likely reflected donor organ quality rather than an effect of RIC .
CONCLUSIONS	RIC did not significantly improve P/F ratios or PGD in this randomized controlled trial .
CONCLUSIONS	However , encouraging results in this small study warrant a large multicenter trial of RIC in lung transplantation .

###24932599
OBJECTIVE	Medical nutritional therapy is important for glycemic control in children and adolescents with type 1 diabetes mellitus ( T1DM ) .
OBJECTIVE	Carbohydrate ( carb ) counting , which is a more flexible nutritional method , has become popular in recent years .
OBJECTIVE	This study aimed to investigate the effects of carb counting on metabolic control , body measurements and serum lipid levels in children and adolescents with T1DM .
METHODS	T1DM patients aged 7-18 years and receiving flexible insulin therapy were divided into carb counting ( n = 52 ) and control ( n = 32 ) groups and were followed for 2 years in this randomized , controlled study .
METHODS	Demographic characteristics , body measurements , insulin requirements , hemoglobin A1c ( HbA1c ) and serum lipid levels at baseline and at follow-up were evaluated .
RESULTS	There were no statistically significant differences between the groups in mean HbA1c values in the year preceding the study or in age , gender , duration of diabetes , puberty stage , total daily insulin dose , body mass index ( BMI ) standard deviation score ( SDS ) and serum lipid values .
RESULTS	While there were no differences in BMI SDS , daily insulin requirement , total cholesterol , low-density lipoprotein and triglyceride values between the two groups ( p > 0.05 ) during the follow-up , annual mean HbA1c levels of the 2nd year were significantly lower in the carb counting group ( p = 0.010 ) .
RESULTS	The mean values of high-density lipoprotein were also significantly higher in the first and 2nd years in the carb counting group ( p = 0.02 and p = 0.043 , respectively ) .
CONCLUSIONS	Carb counting may provide good metabolic control in children and adolescents with T1DM without causing any increase in weight or in insulin requirements .

###25255724
BACKGROUND	To identify the effect of ulinastatin ( UTI ) administration on stress-induced hyperglycemia and acute insulin ( INS ) resistance experienced by patients undergoing partial hepatectomy .
METHODS	Forty-six patients undergoing partial hepatectomy were assigned randomly to the control group ( group C ) or UTI treatment group ( group U ) .
METHODS	Six cases underwent partial hepatectomy but were not eligible for inclusion .
METHODS	The patients in group U had an intravenous infusion of a total amount of 5000 IU/kg UTI before the induction of anesthesia and at the start of surgery .
METHODS	The patients in group C were given an identical volume of physiological saline in the same manner .
METHODS	Blood samples for the measurement of interleukin-6 , cortisol , INS , and glucagon were obtained .
METHODS	Fasting plasma glucose concentration was measured immediately before skin incision ( T1 ) , 20min after the liver lesion was removed ( T2 ) , at the end of surgery ( T3 ) , as well as on the first ( T4 ) and second mornings after partial hepatectomy ( T5 ) .
METHODS	The insulin sensitivity index ( ISI ) was calculated at these time points .
RESULTS	The fasting plasma glucose concentration in group U was significantly lower than that in group C at all time points except for T1 .
RESULTS	In group U , the insulin sensitivity index was higher , and the levels of interleukin-6 , cortisol , and INS were lower than that in group C ( P < 0.05 ) .
CONCLUSIONS	The data suggest that UTI administration improves perioperative hyperglycemia by inhibiting the inflammatory reaction , as well as excessive release of inflammatory factors , and improves INS resistance .

###24848391
OBJECTIVE	To compare the efficacy of subtenon with peribulbar local anesthesia without hyaluronidase in patients undergoing cataract surgery .
METHODS	A randomized controlled trial .
METHODS	Eye `` B '' Unit , Khyber Teaching Hospital , Peshawar , from October 2009 to October 2010 .
METHODS	Patients undergoing cataract surgery were divided into two groups .
METHODS	Group A received subtenon anesthesia and group B received peribulbar anesthesia .
METHODS	Pain score , akinesia and intraocular pressure were compared in the two groups .
METHODS	Statistical Package for Social Sciences-14 .0 was used for data analysis .
RESULTS	There were 304 patients , 152 patients in each group .
RESULTS	At the time of injection , there was less pain in group A as compared to group B ( p < 0.001 ) .
RESULTS	At the time of surgery and till 90 minutes after administration of anesthesia , there was no significant difference in pain between the 2 groups ( p = 0.999 and 0.59 respectively ) .
RESULTS	Group A had better akinesia as compared to group B ( p = 0.04 ) .
RESULTS	There was a greater rise in mean intraocular pressure just after injection in group B as compared to group A ( p < 0.001 ) ; in both groups , the intraocular pressure declined to its base level 10 minutes after the injection ( p = 0.52 ) .
CONCLUSIONS	Subtenon anesthesia is less painful at the time of its administration , provides better akinesia and leads to smaller rise in intraocular pressure just after the injection than peribulbar anesthesia .

###25434837
OBJECTIVE	The objective of this study was to compare the backfill standard voiding trial ( SVT ) that relies on the assessment of voided volume to subjective patients ' evaluation of their voiding based on the assessment of the force of stream ( FOS ) after an outpatient midurethral sling surgery .
METHODS	This double-blinded randomized trial included patients undergoing an outpatient midurethral sling surgery without any other concomitant surgery .
METHODS	Participants were randomized to either the SVT group or to the FOS group .
METHODS	The primary outcome was the rate of catheterization any time up to 6 weeks after surgery .
METHODS	Both groups underwent the same backfill voiding trial protocol postoperatively .
METHODS	Measurements of the voided amount , postvoid residual , and the response to the FOS visual analog scale were collected .
METHODS	The criteria for passing the voiding trial in the SVT group was voiding at least two-thirds of the instilled amount ; while the criteria for passing the trial in the FOS group was assessment of FOS at least 50 % of the baseline , regardless of the voided volume .
METHODS	Participants were interviewed preoperatively and 2-4 days , 7-9 days , and 6 weeks postoperatively .
METHODS	All postoperative interviews included assessments of pain , tolerance of physical activity , urinary FOS , as well as satisfaction with the surgery .
METHODS	Validated questionnaires ( Incontinence Severity Index and Urinary Distress Inventory , short form ) before the surgery and 6 weeks after were used to evaluate urinary symptoms .
RESULTS	A total of 108 patients were enrolled and randomized , and 6-week follow-up data were available for 102 participants ( FOS 50 , SVT 52 ) .
RESULTS	The 2 groups were similar with respect to demographic characteristics and urinary symptoms .
RESULTS	The incidence of catheterization was also similar between the groups ( FOS 13 [ 26 % ] , SVT 13 [ 25.5 % ] ; P = .95 ) .
RESULTS	Amount voided had a moderate correlation with FOS assessment ( Spearman rho 0.5 ; P < .001 ) .
RESULTS	There was no significant difference in mean catheter days , pain scores , Incontinence Severity Index , and Urinary Distress Inventory , short form scores between the 2 groups .
RESULTS	Of the patients who were discharged home without a catheter in either group none required catheter reinsertion within 6 weeks after the surgery .
CONCLUSIONS	Patient 's subjective assessment of the urinary FOS correlated well with the measured voided amount and no difference in catheterization days was noted between the subjective and objective assessment of voiding .
CONCLUSIONS	Thus subjective evaluation of the FOS is a reliable and safe method to use after outpatient midurethral surgery .

###24662009
OBJECTIVE	To examine the effects of whole-body periodic acceleration ( pGz ) on exercise-induced-muscle-damage ( EIMD ) - related symptoms induced by unaccustomed eccentric arm exercise .
METHODS	Seventeen active young men ( 23.4 4.6 y ) made 6 visits to the research facility over a 2-wk period .
METHODS	On day 1 , subjects performed a 1-repetition-maximum ( 1RM ) elbow-flexion test and were randomly assigned to the pGz ( n = 8 ) or control group ( n = 9 ) .
METHODS	Criterion measurements were taken on day 2 , before and immediately after performance of the eccentric-exercise protocol ( 10 sets , 10 repetitions using 120 % 1RM ) and after the recovery period .
METHODS	During subsequent sessions ( 24 , 48 , 72 , and 96 h ) these data were collected before pGz or passive recovery .
METHODS	Measurements included isometric strength ( maximal voluntary contraction [ MVC ] ) , blood markers ( creatine kinase , myoglobin , IL-6 , TNF - , TBARS , PGF2 , protein carbonyls , uric acid , and nitrites ) , soreness , pain , circumference , and range of motion ( ROM ) .
RESULTS	Significantly higher MVC values were seen for pGz throughout the recovery period .
RESULTS	Within-group differences were seen in myoglobin , IL-6 , IL-10 , protein carbonyls , soreness , pain , circumference , and ROM showing small negative responses and rapid recovery for the pGz condition .
CONCLUSIONS	Our results demonstrate that pGz can be an effective tool for the reduction of EIMD and may contribute to the training-adaptation cycle by speeding up the recovery of the body due to its performance-loss-lessening effect .

###25562579
OBJECTIVE	Most patients with anxiety disorders receive treatment in primary care settings .
OBJECTIVE	Limited moderator data are available to inform clinicians of likely prognostic outcomes for individual patients .
OBJECTIVE	We identify baseline characteristics associated with outcome in adults seeking treatment for anxiety disorders .
METHODS	We conducted an exploratory moderator analysis from the Coordinated Anxiety Learning and Management ( CALM ) trial .
METHODS	In the CALM trial , 1,004 adults who met DSM-IV criteria for generalized anxiety disorder ( GAD ) , panic disorder , social anxiety disorder , and/or posttraumatic stress disorder ( PTSD ) were randomized to usual care ( UC ) or a collaborative care intervention ( ITV ) of cognitive-behavioral therapy and/or pharmacotherapy between June 2006 and April 2008 .
METHODS	Logistic regression was used to examine baseline characteristics associated with remission and response overall and by treatment condition .
METHODS	Receiver operating curve ( ROC ) analyses identified subgroups associated with similar likelihood of response and remission of global anxiety symptoms .
METHODS	Remission was defined as score < 6 on the 12-item Brief Symptom Inventory ( BSI-12 ) anxiety and somatization subscales .
METHODS	Response was defined as at least 50 % reduction on BSI-12 , or meeting remission criteria .
RESULTS	Randomization to ITV over UC was often the strongest predictor of outcome .
RESULTS	Several baseline patient characteristics were associated with poor treatment outcome including comorbid depression , increased severity of underlying anxiety disorder ( s ) ( P < .001 ) , low socioeconomic status ( perceived [ P < .001 ] and actual [ P < .05 ] ) , and limited social support ( P < .001 ) .
RESULTS	Patient characteristics associated with particular benefit from ITV were being female ( P < .05 ) , increased depression ( P < .01 ) / GAD severity ( P < .05 ) , and low socioeconomic status ( P < .05 ) .
RESULTS	ROC analysis demonstrated prognostic subgroups with large differences in response likelihood .
CONCLUSIONS	Further research should focus on the effectiveness of implementing the ITV intervention of CALM in community treatment centers where patients typically are of low socioeconomic status and may particularly benefit from ITV .
BACKGROUND	ClinicalTrials.gov identifier : NCT00347269 .

###25401967
BACKGROUND	Muscle spindles endings are extremely sensitive to externally applied vibrations , and under such circumstances they convey proprioceptive inflows to the central nervous system that modulate the spinal reflexes excitability or the muscle responses elicited by postural perturbations .
BACKGROUND	The aim of this pilot study is to test the feasibility and effectiveness of a balance training program in association with a wearable proprioceptive stabilizer ( Equistasi ) that emits focal mechanical vibrations in patients with PD .
METHODS	Forty patients with PD were randomly divided in two groups wearing an active or inactive device .
METHODS	All the patients received a 2-month intensive program of balance training .
METHODS	Assessments were performed at baseline , after the rehabilitation period ( T1 ) , and two more months after ( T2 ) .
METHODS	Posturographic measures were used as primary endpoint ; secondary measures of outcome included the number of falls and several clinical scales for balance and quality of life .
RESULTS	Both groups improved at the end of the rehabilitation period and we did not find significant between-group differences in any of the principal posturographic measures with the exception of higher sway area and limit of stability on the instrumental functional reach test during visual deprivation at T1 in the Equistasi group .
RESULTS	As for the secondary outcome , we found an overall better outcome in patients enrolled in the Equistasi group : 1 ) significant improvement at T1 on Berg Balance Scale ( +45.0 % , p = .026 ) , Activities-specific Balance Confidence ( +83.7 , p = .004 ) , Falls Efficacy Scale ( -33.3 % , p = .026 ) and PDQ-39 ( -48.8 % , p = .004 ) ; 2 ) sustained improvement at T2 in terms of UPDRS-III , Berg Balance Scales , Time Up and Go and PDQ-39 ; 3 ) significant and sustained reduction of the falls rate .
CONCLUSIONS	This pilot trial shows that a physiotherapy program for training balance in association with focal mechanical vibration exerted by a wearable proprioceptive stabilizer might be superior than rehabilitation alone in improving patients ' balance .
BACKGROUND	EudraCT 2013-003020-36 and ClinicalTrials.gov ( number not assigned ) .

###25076372
OBJECTIVE	To compare the effectiveness of limbal relaxing incisions ( LRI ) with that of toric intraocular lens ( IOL ) implantation for the treatment of astigmatism during phacoemulsification using nonvectorial ( predictability , safety , and efficacy ) and vectorial analyses .
METHODS	This longitudinal observational case series assessed 62 eyes of 31 consecutive cataract patients with preoperative corneal astigmatism of 0.75-2 .50 diopters ( D ) in both eyes .
METHODS	Patients were randomly assigned to 2 groups : a toric IOL group , which received toric IOLs in both eyes , and an LRI group , which received spherical IOLs associated with LRI placement in both eyes .
METHODS	All patients were evaluated at 1 , 3 , and 6 months after surgery , when refractive astigmatism analysis was performed using both nonvectorial and Alpins vectorial methods .
METHODS	Outcomes were assessed within each group and compared between groups .
RESULTS	The proportion of eyes within 0.50 D of the intended correction at 3 and 6 months after surgery was 75 % and 71.88 % , respectively , in the LRI group and 40 % and 66.67 % , respectively , in the toric IOL group .
RESULTS	In the remaining period , the proportion was greater in the toric IOL group .
RESULTS	The safety index showed no difference at any time point .
RESULTS	The efficacy index at 1 and 3 months after surgery was significantly higher in the toric IOL group ( 0.43 and 0.44 , respectively ) than in the LRI group ( 0.31 and 0.36 , respectively ) .
RESULTS	At 6 months after surgery , the status of eyes in the LRI group was as follows : 53.13 % were undercorrected , 43.74 % achieved the intended correction , and 3.13 % were overcorrected .
RESULTS	In the toric IOL group , 16.76 % eyes were undercorrected , 76.67 % achieved the intended correction , and 6.67 % were overcorrected .
RESULTS	The success rates for astigmatic surgery , astigmatism reduction at the intended axis , and astigmatism corrected were 43 % , 62 % , and 64 % , respectively , in the LRI group and 57 % , 81 % , and 94 % , respectively , in the toric IOL group .
CONCLUSIONS	Our results suggest that the use of toric IOLs may be advantageous over the use of LRIs for the treatment of astigmatism during phacoemulsification .
CONCLUSIONS	Although such advantages seem subtle in nonvectorial analyses , they are highlighted in vectorial analyses .

###25160064
BACKGROUND	To ensure vaccines safety , given the weaknesses of the national pharmacovigilance system in Cameroon , there is a need to identify effective interventions that can contribute to improving AEFI reporting .
OBJECTIVE	To assess the effect of : ( i ) sending weekly SMS , or ( ii ) weekly supervisory visits on AEFI reporting rate during a meningitis immunization campaign conducted in Cameroon in 2012 using the meningitis A conjugate vaccine ( MenAfriVac ) .
METHODS	Health facilities that met the inclusion criteria were randomly assigned to receive : ( i ) a weekly standardized SMS , ( ii ) a weekly standardized supervisory visits or ( iii ) no intervention .
METHODS	The primary outcome was the reported AEFI incidence rate from week 5 to 8 after the immunization campaign .
METHODS	Poisson regression model was used to estimate the effect of interventions after adjusting for health region , type of health facility , type and position of health workers as well as the cumulative number of AEFI reported from weeks 1 to 4 .
RESULTS	A total of 348 ( 77.2 % ) of 451 health facility were included , and 116 assigned to each of three groups .
RESULTS	The incidence rate of reported AEFI per 100 health facility per week was 20.0 ( 15.9-24 .1 ) in the SMS group , 40.2 ( 34.4-46 .0 ) in supervision group and 13.6 ( 10.1-16 .9 ) in the control group .
RESULTS	Supervision led to a significant increase of AEFI reporting rate compared to SMS [ adjusted RR = 2.1 ( 1.6-2 .7 ) ; p < 0.001 ] and control [ RR = 2.8 ( 2.1-3 .7 ) ; p < 0.001 ) ] groups .
RESULTS	The effect of SMS led to some increase in AEFI reporting rate compared to the control group , but the difference was not statistically significant [ RR = 1.4 ( 0.8-1 .6 ) ; p = 0.07 ) ] .
CONCLUSIONS	Supervision was more effective than SMS or routine surveillance in improving AEFI reporting rate .
CONCLUSIONS	It should be part of any AEFI surveillance system .
CONCLUSIONS	SMS could be useful in improving AEFI reporting rates but strategies need to be found to improve its effectiveness , and thus maximize its benefits .

###25586156
OBJECTIVE	The aims of this study were to evaluate the effect of left ventricular ( LV ) dysfunction on clinical outcomes after transcatheter aortic valve replacement ( TAVR ) and standard therapy for severe aortic stenosis ( AS ) and to assess LV ejection fraction ( LVEF ) recovery and its impact on subsequent clinical outcomes .
METHODS	Cohort B of the Placement of AoRtic TraNscathetER Valves trial randomised 342 inoperable patients with severe AS to TAVR or standard therapy .
METHODS	We defined LV dysfunction as an LVEF < 50 % and LVEF improvement as an absolute increase in LVEF 10 % at 30days .
RESULTS	Baseline LV dysfunction did not affect survival after TAVR but was associated with increased cardiac mortality at 1 year with standard therapy ( 59.3 % vs 45.8 % with normal LVEF ; HR = 1.71 ( 95 % CI 1.08 to 2.71 ) ; p = 0.02 ) .
RESULTS	In those with LV dysfunction , LVEF improvement occurred in 48.7 % and 30.4 % of TAVR and standard therapy patients , respectively ( p = 0.08 ) , and was independently predicted by relative wall thickness and receipt of TAVR .
RESULTS	LVEF improvement with standard therapy portended reduced all-cause mortality at 1year ( 28.6 % vs 65.6 % without LVEF improvement ; HR = 0.32 ( 95 % CI 0.11 to 0.93 ) ; p = 0.03 ) but not at 2years .
CONCLUSIONS	In inoperable patients with severe AS , mild-to-moderate LV dysfunction is associated with higher cardiac mortality with standard therapy but not TAVR .
CONCLUSIONS	A subset of patients undergoing standard therapy with LV dysfunction demonstrates LVEF improvement and favourable 1-year but not 2-year survival .
CONCLUSIONS	TAVR improves survival and should be considered the standard of care for inoperable patients with AS and LVEF > 20 % .
BACKGROUND	ClinicalTrials.gov Unique Identifier #NCT 00530894 .

###25967575
OBJECTIVE	Recent symptoms stand as a major determinant of stroke risk in patients with carotid stenosis , likely reflective of atherosclerotic plaque destabilization .
OBJECTIVE	In view of emerging links between vascular and adipose biology , we hypothesized that human perivascular adipose characteristics associate with carotid disease symptom status .
METHODS	Clinical history , carotid plaques , blood , and subcutaneous and perivascular adipose tissues were prospectively collected from patients undergoing carotid endarterectomy .
METHODS	Nine adipose-associated biological mediators were assayed and compared in patients with symptomatic ( n = 15 ) versus asymptomatic ( n = 19 ) disease .
METHODS	Bonferroni correction was performed for multiple testing ( / 9 = 0.006 ) .
RESULTS	Symptomatic patients had 1.9-fold higher perivascular adiponectin levels ( P = 0.005 ) .
RESULTS	Other circulating , subcutaneous , and perivascular biomarkers , as well as microscopic plaque characteristics , did not differ between symptomatic and asymptomatic patients .
CONCLUSIONS	Symptomatic and asymptomatic carotid endarterectomy patients display a tissue-specific difference in perivascular adipose adiponectin .
CONCLUSIONS	This difference , which was not seen in plasma or subcutaneous compartments , supports a potential local paracrine relationship with vascular disease processes that may be related to stroke mechanisms .

###25262164
OBJECTIVE	We conducted a phase III randomized controlled trial ( RCT ) to investigate the efficacy of postsurgical adjuvant immunotherapy combined with chemotherapy .
OBJECTIVE	The immunotherapy targets were residual micrometastases and clones resistant to chemotherapy .
METHODS	Between April 2007 and July 2012 , 103 postsurgical non-small cell lung cancer patients were randomly assigned to receive either chemo-immunotherapy ( group A ) or chemotherapy ( group B ) .
METHODS	The immunotherapy consisted of the adoptive transfer of autologous activated killer T cells and dendritic cells obtained from the lung cancer patients ' own regional lymph nodes .
RESULTS	The 2-year overall survival rates in groups A and B were 93.4 and 66.0 % , and the 5-year rates were 81.4 and 48.3 % , respectively .
RESULTS	The differences were statistically significantly better in group A.
RESULTS	The hazard ratio ( HR ) was 0.229 ( p = 0.0013 ) .
RESULTS	The 2 - and 5-year recurrence-free survival rates were 68.5 , 41.4 and 56.8 , 26.2 % in groups A and B , respectively .
RESULTS	Those differences were also statistically significant ( log-rank test p = 0.0020 ) .
RESULTS	The HR was 0.423 ( p = 0.0027 ) in favor of group A.
RESULTS	As for adverse reactions to immunotherapy , of a total of 762 courses , 52 ( 6.8 % ) were accompanied with chills and shivering , and 47 ( 6.2 % ) , with fever ( > 38 C ) .
CONCLUSIONS	Immunotherapy has the potential to improve the postsurgical prognosis of lung cancer patients , but a large-scale multi-institutional RCT is awaited for further confirmation of this study .

###24552755
OBJECTIVE	To assess the clinical performance of Systane Ultra lubricant eye drops in daily disposable soft contact lens wearers who experience contact lens-related dryness .
METHODS	In this randomized , investigator-masked study , daily disposable lens wearers with symptoms of dryness were randomized to use Systane Ultra lubricant eye drops or to no treatment .
METHODS	The lubricant regimen was applied twice a day , 10 minutes before lens insertion and after lens removal , for the 2-week study period .
METHODS	Subjective comfort , wear time , and visual acuity were assessed at baseline and after 2 weeks .
RESULTS	A total of 89 daily disposable lens wearers were randomly assigned to the Systane Ultra group ( n = 44 ) or the control group ( n = 45 ) .
RESULTS	Two weeks of Systane Ultra lubricant eye drop use resulted in a significant increase in comfortable lens wear time when compared with baseline assessment ( P = 0.001 ) and a trend toward significant improvement compared with the control group ( P = 0.078 ) .
RESULTS	End-of-the-day comfort was significantly improved in the Systane Ultra group compared with the control group ( P = 0.007 ) .
RESULTS	A significant reduction in the overall dryness ( P < 0.001 ) and end-of-day dryness ( P = 0.047 ) was observed in subjects using the Systane Ultra lubricant eye drops compared with the control group .
CONCLUSIONS	The study demonstrates that Systane Ultra lubricant eye drops applied before and after contact lens wear is an effective artificial tear for alleviating symptoms of contact lens-related dry eye .

###25509708
OBJECTIVE	The teaching of medicine has varied and has continued to develop until today .
OBJECTIVE	Most courses rely on the lecture although it may bring less benefit to students .
OBJECTIVE	Another teaching technique , the open group discussion , may not be the most effective , but is widely accepted as a teaching development especially for its overall improvement of student skills .
OBJECTIVE	Basically , the teaching of surgery has more limitations than other subjects because patients with critical conditions are required .
OBJECTIVE	The present study was designed to compare the effectiveness of these two teaching methods , the lecture and the open group discussion , in the Department of Surgery , Rajavithi Hospital .
METHODS	Fifth year medical students enrolled from 2554-2555 BE ( AD 2011-2012 ) were recruited in the study and randomly divided in groups by the Office of Administration , College of Medicine , Rangsit University .
METHODS	A colorectal surgeon taught the subject , common anorectal disease , throughout the study year .
METHODS	The drawing method was used to randomize the members grouped by teaching methods .
METHODS	The assessment comprised multiple choice questions ( MCQ ) and multiple essay questions ( MEQ ) .
RESULTS	Seventy-three students ( 39 females , 34 males ) were recruited .
RESULTS	Students ' basic characteristic showed no association between groups of teaching methods .
RESULTS	Higher mean MEQ scores were found in the open discussion group ( 55.83 % ) compared with those taught by lecture ( 31.23 % ) , exhibiting significant difference ( p < 0.001 ) .
RESULTS	With respect to MCQ1 and MCQ4 , students in the open discussion group had higher scores than those in the lecture group ) , was also with statistical significance ( p = 0.02 ) .
CONCLUSIONS	Teaching medicine differs from other disciplines .
CONCLUSIONS	To achieve the most effective teaching performance , teaching methods may be limited in some subjects .
CONCLUSIONS	This study was a partial project for teaching in the Department of Surgery .
CONCLUSIONS	It was shown that students in the open discussion group had better MCQ and MEQ scores than those in the lecture group .
CONCLUSIONS	In developing student skills , giving open discussion provided greater interaction between instructors and students .
CONCLUSIONS	Importantly , the instructor should manage and facilitate questioning techniques to more effectively transfer course content .

###24717951
BACKGROUND	Sublingual immunotherapy ( SLIT ) is recommended for allergic diseases .
BACKGROUND	However , clinical studies containing evidence-based data of this treatment in young children , which is rarely reported in the literature , are needed .
BACKGROUND	This study was designed to assess the efficacy and safety of SLIT in children , including very young children .
METHODS	Two hundred sixty-four children aged 3-13 years old ( 133 children , 3-5 years old ) with Dermatophagoides farinae-induced allergic rhinitis with or without asthma treated by standard pharmacotherapy had randomly received either SLIT ( SLIT group ) or no SLIT ( control group ) for 12 months .
METHODS	Symptoms , medications , visual analog scale ( VAS ) and presence of adverse events ( AEs ) were assessed at monthly visits .
METHODS	Skin-prick test and Dermatophagoides farinae-specific IgE and IgG4 were measured before and after treatment .
RESULTS	Both treatments were effective in the global clinical scores during the first seven visits when compared with baseline ( all , p < 0.01 ) , and SLIT showed lower symptoms scores and VAS scores throughout this period ( all , p < 0.01 ) .
RESULTS	These improvements continued until the later visits only in the SLIT group .
RESULTS	Also , the asthma medication consumption was decreased by SLIT treatment only at the end of study ( p < 0.01 ) .
RESULTS	The specific IgG4 was significantly increased after SLIT treatment when compared with the control group , but no significant change of specific IgE was observed in either groups .
RESULTS	In the SLIT group , there was no significant difference between children less than or more than 5 years old in terms of clinical efficacy , onset of action , immunologic parameters , and safety .
RESULTS	No severe systemic AEs were reported .
CONCLUSIONS	SLIT is effective and well-tolerated in children with allergic rhinitis 3-13 years old .

###24964745
OBJECTIVE	This study was performed to prospectively and independently validate the Global Antiphospholipid Syndrome Score ( GAPSS ) , a system derived from the combination of independent risk factors for thrombosis , including antiphospholipid antibodies ( aPL ) and conventional cardiovascular risk factors .
METHODS	The GAPSS was applied to 51 consecutive systemic lupus erythematosus patients , all positive for aPL and prospectively followed up for mean SD 32.94 12.06 months .
METHODS	Of them , 48 were women with a mean SD age of 37.35 12.15 years at entry .
METHODS	The GAPSS was calculated yearly for each patient by adding together the points corresponding to the risk factors .
RESULTS	An increase in the GAPSS ( entry versus last visit ) was seen in patients who experienced vascular events ( n = 4 , mean SD 7.5 4.36 versus 10.0 5.4 ; P = 0.032 ) .
RESULTS	No changes were observed in those without thrombosis ( n = 47 , mean SD 8.28 4.88 versus 7.13 5.75 ; P = 0.24 ) .
RESULTS	An increase in the GAPSS during the followup was associated with a higher risk of vascular events ( relative risk 12.30 [ 95 % confidence interval ( 95 % CI ) 1.43-106 .13 ] , P = 0.004 ) , and an increase of more than 3 points showed the best risk accuracy for vascular events ( hazard ratio 48 [ 95 % CI 6.90-333 .85 ] , P = 0.0001 ) .
RESULTS	The cumulative proportion of thrombosis-free individuals was lower in patients whose GAPSS was increased by 3 or more points ( P = 0.0027 ) .
CONCLUSIONS	We have prospectively demonstrated that GAPSS is a valid tool for accurate prediction of vascular events in SLE patients with aPL .

###25038357
OBJECTIVE	Among patients infected with human immunodeficiency virus ( HIV ) , visceral adiposity is associated with metabolic dysregulation and ectopic fat accumulation .
OBJECTIVE	Tesamorelin , a growth hormone-releasing hormone analog , specifically targets visceral fat reduction but its effects on liver fat are unknown .
OBJECTIVE	To investigate the effect of tesamorelin on visceral and liver fat .
METHODS	Double-blind , randomized , placebo-controlled trial conducted among 50 antiretroviral-treated HIV-infected men and women with abdominal fat accumulation at Massachusetts General Hospital in Boston .
METHODS	The first patient was enrolled on January 10 , 2011 ; for the final patient , the 6-month study visit was completed on September 6 , 2013 .
METHODS	Participants were randomized to receive tesamorelin , 2 mg ( n = 28 ) , or placebo ( n = 22 ) , subcutaneously daily for 6 months .
METHODS	Primary end points were changes in visceral adipose tissue and liver fat .
METHODS	Secondary end points included glucose levels and other metabolic end points .
RESULTS	Forty-eight patients received treatment with study drug .
RESULTS	Tesamorelin significantly reduced visceral adipose tissue ( mean change , -34 cm2 [ 95 % CI , -53 to -15 cm2 ] with tesamorelin vs 8 cm2 [ 95 % CI , -14 to 30 cm2 ] with placebo ; treatment effect , -42 cm2 [ 95 % CI , -71 to -14 cm2 ] ; P = .005 ) and liver fat ( median change in lipid to water percentage , -2.0 % [ interquartile range { IQR } , -6.4 % to 0.1 % ] with tesamorelin vs 0.9 % [ IQR , -0.6 % to 3.7 % ] with placebo ; P = .003 ) over 6 months , for a net treatment effect of -2.9 % in lipid to water percentage .
RESULTS	Fasting glucose increased in the tesamorelin group at 2 weeks ( mean change , 9 mg/dL [ 95 % CI , 5-13 mg/dL ] vs 2 mg/dL [ 95 % CI , -3 to 8 mg/dL ] in the placebo group ; treatment effect , 7 mg/dL [ 95 % CI , 1-14 mg/dL ] ; P = .03 ) , but changes at 6 months in fasting glucose ( mean change , 4 mg/dL [ 95 % CI , -2 to 10 mg/dL ] with tesamorelin vs 2 mg/dL [ 95 % CI , -4 to 7 mg/dL ] with placebo ; treatment effect , 2 mg/dL [ 95 % CI , -6 to 10 mg/dL ] ; P = .72 overall across time points ) and 2-hour glucose ( mean change , -1 mg/dL [ 95 % CI , -18 to 15 mg/dL ] vs -8 mg/dL [ 95 % CI , -24 to 8 mg/dL ] , respectively ; treatment effect , 7 mg/dL [ 95 % CI , -16 to 29 mg/dL ] ; P = .53 overall across time points ) were not significant .
CONCLUSIONS	In this preliminary study of HIV-infected patients with abdominal fat accumulation , tesamorelin administered for 6 months was associated with reductions in visceral fat and additionally with modest reductions in liver fat .
CONCLUSIONS	Further studies are needed to determine the clinical importance and long-term consequences of these findings .
BACKGROUND	clinicaltrials.gov Identifier : NCT01263717 .

###24823623
BACKGROUND	The phase III Zostavax Efficacy and Safety Trial of 1 dose of licensed zoster vaccine ( ZV ; Zostavax ; Merck ) in 50-59-year-olds showed approximately 70 % vaccine efficacy ( VE ) to reduce the incidence of herpes zoster ( HZ ) .
BACKGROUND	An objective of the trial was to assess immune response biomarkers measuring antibodies to varicella zoster virus ( VZV ) by glycoprotein-based enzyme-linked immunosorbent assay as correlates of protection ( CoPs ) against HZ .
METHODS	The principal stratification vaccine efficacy curve framework for statistically evaluating immune response biomarkers as CoPs was applied .
METHODS	The VE curve describes how VE against the clinical end point ( HZ ) varies across participant subgroups defined by biomarker readout measuring vaccine-induced immune response .
METHODS	The VE curve was estimated using several subgroup definitions .
RESULTS	The fold rise in VZV antibody titers from the time before immunization to 6 weeks after immunization was an excellent CoP , with VE increasing sharply with fold rise : VE was estimated at 0 % for the subgroup with no rise and at 90 % for the subgroup with 5.26-fold rise .
RESULTS	In contrast , VZV antibody titers measured 6 weeks after immunization did not predict VE , with similar estimated VEs across titer subgroups .
CONCLUSIONS	The analysis illustrates the value of the VE curve framework for assessing immune response biomarkers as CoPs in vaccine efficacy trials .
BACKGROUND	NCT00534248 .

###24978856
BACKGROUND	Immunogenicity and safety of the HPV-16 / 18 AS04-adjuvanted vaccine were evaluated up to 6 years postvaccination ( month 72 ) in preteen/adolescent girls .
METHODS	Participants , who had received 3 HPV-16 / 18 AS04-adjuvanted vaccine doses at 10-14 years of age in an initial controlled , observer-blinded , randomized study ( NCT00196924 ) and participated in the open 3-year follow-up ( NCT00316706 ) , were invited to continue the follow-up for up to 10 years postvaccination ( NCT00877877 ) .
METHODS	Anti-HPV-16 and -18 antibody titers were measured by enzyme-linked immunosorbent assays at yearly visits and were used to fit the modified power-law and piecewise models , predicting long-term immunogenicity .
METHODS	Serious adverse events ( SAEs ) and pregnancy information were recorded .
RESULTS	In the according-to-protocol immunogenicity cohort , all participants ( N = 505 ) with data available remained seropositive for anti-HPV-16 and -18 antibodies at month 72 .
RESULTS	In initially seronegative participants , anti-HPV-16 and -18 antibody geometric mean titers were 65.8 - and 33.0-fold higher than those associated with natural infection ( NCT00122681 ) and 5.0 - and 2.5-fold higher than those measured at month 69-74 in a study demonstrating vaccine efficacy in women aged 15-25 years ( NCT00120848 ) .
RESULTS	Exploratory antibody modeling , based on the 6-year data , predicted that vaccine-induced population anti-HPV-16 and -18 antibody geometric mean titers would remain above those associated with natural infection for at least 20 years postvaccination .
RESULTS	The HPV-16 / 18 AS04-adjuvanted vaccine safety profile was clinically acceptable .
CONCLUSIONS	In preteen/adolescent girls , the HPV-16 / 18 AS04-adjuvanted vaccine induced high anti-HPV-16 and -18 antibody levels up to 6 years postvaccination , which were predicted to remain above those induced by natural infection for at least 20 years .

###25461690
BACKGROUND	The currently recommended duration of dual antiplatelet therapy ( DAPT ) in drug-eluting stent ( DES ) recipients is 12 months to reduce the risk of late stent thrombosis , particularly in those with acute coronary syndrome ( ACS ) .
OBJECTIVE	This study hypothesized that antiplatelet treatment with DAPT for 6 months may be noninferior to 24-month DAPT in aspirin-sensitive patients .
METHODS	A multicenter , randomized study assigned patients undergoing implantation of everolimus-eluting stents with confirmed nonresistance to aspirin to receive 6 - or 24-month DAPT .
METHODS	The primary endpoint was a composite of death , myocardial infarction , urgent target vessel revascularization , stroke , and major bleeding at 12 months post-stenting .
RESULTS	A total of 2,031 patients were enrolled in 70 European and Middle Eastern centers .
RESULTS	The trial was prematurely terminated due to recruitment problems , leaving 941 patients randomized to 24-month DAPT and 953 to 6-month DAPT .
RESULTS	The 2 treatment groups had similar baseline and procedural characteristics .
RESULTS	There was no significant difference in the primary endpoint ( 24-month : 1.5 % vs. 6-month : 1.6 % ; p = 0.85 ) .
RESULTS	Noninferiority was demonstrated for 6 - versus 24-month DAPT , with an absolute risk difference of 0.11 % ( 95 % confidence interval : -1.04 % to 1.26 % ; p for noninferiority = 0.0002 ) .
RESULTS	There were no significant differences in stent thrombosis or bleeding complications .
RESULTS	In the 792 ( 44 % ) high-risk patients with ACS , primary and secondary endpoints did not significantly differ ( hazard ratio : 1.7 [ 95 % confidence interval : 0.519 to 6.057 ; p = 0.361 ] ) .
CONCLUSIONS	Rates of bleeding and thrombotic events were not significantly different according to 6 - versus 24-month DAPT after PCI with new-generation DES in good aspirin responders .
CONCLUSIONS	( Is There A LIfe for DES After Discontinuation of Clopidogrel [ ITALICplus ] ; NCT01476020 ) .

###24366001
OBJECTIVE	Arthroscopic subacromial decompression may cause substantial postoperative pain .
OBJECTIVE	We undertook a randomized controlled trial to examine whether adding dexmedetomidine to the local anesthetic in an interscalene brachial plexus block and subsequent patient-controlled interscalene analgesia ( PCIA ) regime improved postoperative pain scores , patient satisfaction , rescue analgesic requirement , and local anesthetic consumption .
METHODS	A total of 48 patients aged between 18 and 65 years undergoing arthroscopic subacromial decompression were enrolled and randomized into 1 of the 2 groups .
METHODS	Group L ( n = 25 ) received levobupivacaine and epinephrine , whereas Group LD ( n = 23 ) received levobupivacaine , epinephrine , and dexmedetomidine through an interscalene catheter .
METHODS	Four hours after surgery , a PCIA regime was commenced .
METHODS	In Group L patients were administered levobupivacaine and in Group LD levobupivacaine and dexmedetomidine .
METHODS	Demographic and hemodynamic data , duration of motor and sensory blocks , pain VAS , side effects , PCIA demand and delivery values , consumption of lornoxicam as a rescue analgesic , and patient satisfaction were recorded for 24 hours after surgery .
RESULTS	PCIA demand and delivery , and pain VAS values were significantly lower , and patient satisfaction was significantly higher in the dexmedetomidine group ( P = 0.004 , 0.001 , 0.004 , and 0.002 , respectively ) .
RESULTS	The side effect profile was similar between the groups .
RESULTS	Levobupivacaine consumption was significantly lower in Group LD ( P = 0.009 ) .
RESULTS	In the first 24 postoperative hours , Group LD consumed significantly less lornoxicam ( P = 0.01 ) .
CONCLUSIONS	Addition of dexmedetomidine to levobupivacaine for interscalene brachial plexus block decreases pain scores and increases patient satisfaction after arthroscopic subacromial decompression .

###25428714
BACKGROUND	Iron-deficient erythropoiesis results in excess formation of zinc protoporphyrin ( ZPP ) , which can be measured instantly and at low assay cost using portable haematofluorometers .
BACKGROUND	ZPP is used as a screening marker of iron deficiency in individual pregnant women and children , but also to assess population iron status in combination with haemoglobin concentration .
BACKGROUND	We examined associations between ZPP and disorders that are common in Africa .
BACKGROUND	In addition , we assessed the diagnostic utility of ZPP ( measured in whole blood and erythrocytes ) , alone or in combination with haemoglobin concentration , in detecting iron deficiency ( plasma ferritin concentration < 15 g/L ) .
METHODS	Single blood samples were collected from a population sample of 470 rural Kenyan women with singleton pregnancies , gestational age 13 to 23 weeks , and haemoglobin concentration 90 g/L .
METHODS	We used linear regression analysis to assess associations between ZPP and iron markers ( including anaemia ) , factors known or suspected to be associated with iron status , inflammation markers ( plasma concentrations of C-reactive protein and 1-acid glycoprotein ) , infections ( Plasmodium infection , HIV infection ) , and other disorders ( ( + ) - thalassaemia , plasma concentrations of total bilirubin , and lactate dehydrogenase ) .
METHODS	Subsequently , in those without inflammation , Plasmodium infection , or HIV infection , we used logistic discriminant analysis and examined receiver operating characteristics curves with corresponding area-under-the-curve to assess diagnostic performance of ZPP , alone and in combination with haemoglobin concentration .
RESULTS	Individually , whole blood ZPP , erythrocyte ZPP , and erythrocyte protoporphyrin had limited ability to discriminate between women with and without iron deficiency .
RESULTS	Combining each of these markers with haemoglobin concentration had no additional diagnostic value .
RESULTS	Conventional cut off points for whole blood ZPP ( > 70 mol/mol haem ) resulted in gross overestimates of the prevalence of iron deficiency .
CONCLUSIONS	Erythrocyte ZPP has limited value to rule out iron deficiency when used for screening in conditions with a low prevalence ( e.g. , 10 % ) .
CONCLUSIONS	ZPP is of unreliable diagnostic utility when discriminating between pregnant women with and without iron deficiency .
CONCLUSIONS	Based on these findings , guidelines on the use of ZPP to assess iron status in individuals or populations of pregnant women need review .
BACKGROUND	NCT01308112 ( 2 March 2011 ) .

###25659155
OBJECTIVE	To evaluate hepatic fat fraction on dual - and triple-echo gradient-recalled echo MRI sequences in healthy children .
METHODS	We retrospectively reviewed the records of children in a medical check-up clinic from May 2012 to November 2013 .
METHODS	We excluded children with abnormal laboratory findings or those who were overweight .
METHODS	Hepatic fat fraction was measured on dual - and triple-echo sequences using 3T MRI .
METHODS	We compared fat fractions using the Wilcoxon signed rank test and the Bland-Altman 95 % limits of agreement .
METHODS	The correlation between fat fractions and clinical and laboratory findings was evaluated using Spearman 's correlation test , and the cut-off values of fat fractions for diagnosing fatty liver were obtained from reference intervals .
RESULTS	In 54 children ( M : F = 26:28 ; 5-15 years ; mean 9 years ) , the dual fat fraction ( 0.1-8 .0 % ; median 1.6 % ) was not different from the triple fat fraction ( 0.4-6 .5 % ; median 2.7 % ) ( p = 0.010 ) .
RESULTS	The dual - and triple-echo fat fractions showed good agreement using a Bland-Altman plot ( -0.6 2.8 % ) .
RESULTS	Eight children ( 14.8 % ) on dual-echo sequences and six ( 11.1 % ) on triple-echo sequences had greater than 5 % fat fraction .
RESULTS	From these children , six out of eight children on dual-echo sequences and four out of six children on triple-echo sequences had a 5-6 % hepatic fat fraction .
RESULTS	When using a cut-off value of a 6 % fat fraction derived from a reference interval , only 3.7 % of children were diagnosed with fatty liver .
RESULTS	There was no significant correlation between clinical and laboratory findings with dual and triple-echo fat fractions .
CONCLUSIONS	Dual fat fraction was not different from triple fat fraction .
CONCLUSIONS	We suggest a cut-off value of a 6 % fat fraction is more appropriate for diagnosing fatty liver on both dual - and triple-echo sequences in children .

###24614142
OBJECTIVE	The aim of this study was to investigate the effect of growing-up milk ( GUM ) with added short-chain galacto-oligosaccharides ( scGOS ) / long-chain fructo-oligosaccharides ( lcFOS ) ( 9:1 ) ( Immunofortis ) and n-3 long-chain polyunsaturated fatty acids ( LCPUFAs ) on the occurrence of infections in healthy children attending day care centres .
METHODS	In a randomised double-blind controlled , parallel , multicountry intervention study , 767 healthy children , ages 11 to 29 months , received GUM with scGOS/lcFOS/LCPUFAs ( the active group , n = 388 ) , GUM without scGOS/lcFOS/LCPUFAs ( the control group , n = 379 ) , or cow 's milk ( n = 37 ) for 52 weeks .
METHODS	The primary outcome measure was the number of episodes of upper respiratory tract infections or gastrointestinal infections based on a combination of subject 's illness symptoms reported by the parents during the intervention period .
RESULTS	Children in the active group compared with the control group had a decreased risk of developing at least 1 infection ( 299/388 [ 77 % ] vs 313/379 [ 83 % ] , respectively , relative risk 0.93 , 95 % confidence interval [ CI ] 0.87-1 .00 ; logistic regression P = 0.03 ) .
RESULTS	There was a trend toward a reduction ( P = 0.07 ) in the total number of infections in the active group , which was significant when confirmed by one of the investigators ( 268/388 [ 69 % ] vs 293/379 [ 77 % ] , respectively , relative risk 0.89 , 95 % CI 0.82-0 .97 ; P = 0.004 , post hoc ) .
RESULTS	More infectious episodes were observed in the cow 's milk group , when compared with both GUM groups ( 34/37 [ 92 % ] vs 612/767 [ 80 % ] , respectively , relative risk 1.15 , 95 % CI 1.04-1 .28 ) .
CONCLUSIONS	This is the first study in children to show a reduced risk of infection following consumption of GUM supplemented with scGOS/lcFOS/n -3 LCPUFAs .
CONCLUSIONS	The borderline statistical significance justifies a new study to confirm this finding .

###25847553
OBJECTIVE	Obesity and overweight are the fifth most fatal diseases leading to an increased rate of morbidity and mortality in global population , with its incidence increasing drastically .
OBJECTIVE	Taking this into consideration we have conducted the present study in order to explore the efficacy of plant based formulation in the management of adolescent obesity and its associated biomarkers .
METHODS	Randomized , double blind , placebo controlled trial was conducted in 130 obese adolescent of both sexes , with BMI above 25kg/m ( 2 ) .
METHODS	The subjects were randomly assigned into test formulation group ( TFG ) and placebo group ( PG ) .
METHODS	TFG received two 500mg capsule containing test formulation whereas , the PG received two 500mg of cellulose powder containing capsule daily for 3 months .
METHODS	The parameters such as blood pressure , inflammatory cytokines , adipokines and lipid profile were assessed in all subjects pre and post treatment .
RESULTS	There was a considerable improvement in the levels of lipid profile , inflammatory cytokines , adipokines and blood pressure after treatment in TFG compared to PG .
RESULTS	The statistical difference obtained between the groups after three months of treatment for the various biomarkers are given as mean with 95 % CI for BMI ( -1.40.6 ( -2.5 to -0.7 ) ) , total cholesterol mg/dl ( -20.95.0 ( -30.8 to -11.0 ) ) , triglyceride mg/dl ( -12.95.7 ( -23.9 to -1.2 ) ) , HDL-c mg/dl ( 7.20.8 ( 5.6-8 .8 ) ) , IL-6 ( -0.70.1 ( -0.9 to -0.6 ) ) , hs C-reactive protein ( CRP ) mg/l ( -1.00.01 ( -1.2 to -0.8 ) ) , adiponectin g/ml ( 4.90.4 ( 4.2-5 .7 ) ) , leptin ng/ml ( -8.01.4 ( -10.7 to -5.3 ) ) , diastolic blood pressure ( DBP ) mmHg ( -10.40.8 ( -12.0 to -8.7 ) ) and systolic blood pressure ( SBP ) mmHg ( -6.70.7 ( -8.1 to -5.3 ) ) .
RESULTS	Also , there was a statistical significance within group TFG .
CONCLUSIONS	The study concludes that the test formulation may prevent the future cardio vascular risk incidence in obese adolescents by reducing inflammation , overweight , lipid profile and by regulating adipokines .
CONCLUSIONS	Thus it may help to improve the health pattern in obese patients with least side effects .

###24985959
OBJECTIVE	To investigate whether ambient orange fragrance , compared with no fragrance , can reduce patient anxiety before and during surgical removal of an impacted mandibular third molar .
METHODS	In the present randomized clinical trial , the patients who required extraction of an impacted mandibular third molar and fulfilled the predetermined criteria were included .
METHODS	A dental anxiety scale ( DAS ) questionnaire was used to determine the anxiety level of the patients before surgery .
METHODS	Only patients with moderate and high anxiety levels ( DAS scale 9 to 14 ) were included .
METHODS	The predictor variable was fragrance exposure .
METHODS	The fragrance group was exposed to orange fragrance , and the control group was exposed to no fragrance .
METHODS	The outcome variables were physiologic measures related to anxiety , including the mean blood pressure , respiratory rate , and pulse rate .
METHODS	The physiologic vital changes were determined before and during the surgical procedure .
METHODS	The data were analyzed using the independent t test , ( 2 ) test , and Mann-Whitney U test ( Statistical Package for Social Sciences , version 16 ; = 0.05 ) .
RESULTS	A total of 56 patients fulfilled the inclusion criteria ( fragrance group , 19 males and 9 females ; no-fragrance group , 12 males and 16 females ) .
RESULTS	Before entering the waiting room , the patients ' vital signs were recorded twice .
RESULTS	No significant differences were found between the 2 groups .
RESULTS	The mean blood pressure , pulse rate , and respiratory rate were significantly lower in the fragrance group during surgery ( from sitting in the dental chair to the end of surgery ; P < .05 ) .
CONCLUSIONS	The results of our study have shown that orange fragrance is effective in reducing the anxiety related to surgical removal of an impacted mandibular third molar .

###25260838
BACKGROUND	Many patients with acromegaly do not achieve biochemical control despite receiving high doses of the first-generation somatostatin analogues octreotide or lanreotide .
BACKGROUND	In the PAOLA trial , we aimed to assess the efficacy and safety of two different doses of the somatostatin analogue pasireotide long-acting release compared with active control ( octreotide or lanreotide ) in patients with inadequately controlled acromegaly .
METHODS	In a multicentre , randomised , phase 3 trial , we enrolled eligible patients aged 18 years or older with acromegaly who were inadequately controlled ( 5-point , 2 h mean growth hormone concentration > 25 g/L and insulin-like growth factor 1 [ IGF-1 ] concentration > 13 times the upper normal limit ) and had received 30 mg octreotide long-acting repeatable or 120 mg lanreotide ( Somatuline Autogel ; Ipsen , UK ) as monotherapy for 6 months or longer .
METHODS	We randomly assigned patients in a 1:1:1 ratio with an interactive voice-web response system to receive 40 mg pasireotide long-acting release once every 28 days for 24 weeks , 60 mg pasireotide long-acting release once every 28 days for 24 weeks , or continued treatment with octreotide or lanreotide ( active control ) .
METHODS	Patients were stratified according to previous treatment ( octreotide or lanreotide ) and growth hormone concentrations at screening ( 25-10 g/L and > 10 g/L ) .
METHODS	Patients and study investigators were not masked to study drug assignment but were masked to pasireotide dose allocation .
METHODS	The primary endpoint was number of patients achieving biochemical control , defined as mean growth hormone concentration less than 25 g/L and normalised IGF-1 concentration .
METHODS	Efficacy analyses were based on intention to treat .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01137682 .
RESULTS	Between Dec 17 , 2010 , and Aug 6 , 2012 , 198 patients were enrolled and randomly assigned to pasireotide 40 mg ( n = 65 ) , pasireotide 60 mg ( n = 65 ) , or active control ( n = 68 ) groups .
RESULTS	At 24 weeks , ten ( 15 % ) patients in the pasireotide 40 mg group and 13 ( 20 % ) patients in the pasireotide 60 mg group achieved biochemical control , compared with no patients in the active control group ( absolute difference from control group 154 % , 95 % CI 76-265 , p = 00006 for pasireotide 40 mg group , 200 % , 111-318 , p < 00001 for pasireotide 60 mg group ) .
RESULTS	The most common adverse events were hyperglycaemia ( 21 [ 33 % ] for treatment with 40 mg pasireotide , 19 [ 31 % ] with 60 mg pasireotide , and nine [ 14 % ] with active control ) , diabetes ( 13 [ 21 % ] , 16 [ 26 % ] , and five [ 8 % ] ) , and diarrhoea ( ten [ 16 % ] , 12 [ 19 % ] , and three [ 5 % ] ) ; most were grade 1 or 2 in severity .
RESULTS	Serious adverse events were reported in six ( 10 % ) patients in the pasireotide 40 mg group , two ( 3 % ) in the pasireotide 60 mg group , and three ( 5 % ) in the active control group .
CONCLUSIONS	Pasireotide provides superior efficacy compared with continued treatment with octreotide or lanreotide , and could become the new standard pituitary-directed treatment in patients with acromegaly who are inadequately controlled using first-generation somatostatin analogues .
BACKGROUND	Novartis Pharma AG .
BACKGROUND	Financial support for medical editorial assistance was provided by Novartis Pharmaceuticals Corporation .

###25232265
OBJECTIVE	To test efficacy and durability of a polyphenol-based prebiotic treatment for acute gastroenteritis in a 300 patient double-blinded clinical study .
METHODS	A two-arm randomized , double-blinded , placebo-controlled clinical study was conducted at two public health centers in Managua , Nicaragua .
METHODS	Potential subjects who qualified based on inclusion and exclusion criteria were randomly assigned to one of two treatment arms .
METHODS	Two thirds of the subjects ( n = 200 ) received a single titrated 0.5-2 ounce liquid dose of a novel polyphenol-based prebiotic ( Aliva ( TM ) ) diluted with 2 to eight ounces of oral rehydration solution ( ORS ) .
METHODS	One third of the subjects ( n = 100 ) were randomized to receive two liquid ounces of a taste and color-matched placebo diluted in eight ounces of ORS .
METHODS	The outcome variables measured included stool consistency , stomach discomfort , gas and bloating , and heartburn/indigestion .
METHODS	The study subjects ranked their stool consistency and the severity of their subjective symptoms at specified intervals from immediately prior to treatment , to five days post treatment .
METHODS	All subjects recorded their symptoms in a study diary .
METHODS	The study subjects also recorded the time and consistencies of all stools in their study diary .
METHODS	Stool consistency was compared to the picture and descriptions on the Bristol Stool Chart , and any stool rated greater than Type 4 was considered unformed .
METHODS	The clinical study team reviewed the study diaries with subjects during daily follow-up calls and close-out visits , and recorded the data in case report forms .
RESULTS	After receiving a single dose , Aliva treated subjects reported shorter median time to their last unformed stool ( 1 h 50 min ) than placebo treated subjects ( 67 h 50 min . )
RESULTS	, a statistically significant difference [ 95 % CI : -3178 - ( -2018 ) , P = 0.000 ] .
RESULTS	Aliva treated subjects also reported shorter median their time to last unformed stool ( TTLUS ) ( 1 hrs 50 min ) than placebo treated subjects ( 67 h 50 min ) , which was also a statistically significant difference ( P = 0.000 ) .
RESULTS	The percentage of subjects recording TTLUS was greater for those who received Aliva vs placebo at 30 min ( P = 0.027 ) , 2 h ( P = 0.000 ) , 24 h ( P = 0.000 ) , 48 h ( P = 0.000 ) , 72 h ( P = 0.000 ) , and 5 d ( P = 0.000 ) post dose .
RESULTS	There were 146 study subjects 14 years old or older , which was the criteria set for reliable self-reporting of subjective symptoms .
RESULTS	Of those 146 subjects , 142 reported stomach pain and discomfort during screening .
RESULTS	From 90 minutes [ 95 % CI : -1.8 - ( -0.01 ) , P = 0.048 ] through 5 d [ 95 % CI : -3.4 - ( -1.9 ) , P = 0.000 ) , the subjects treated with Aliva experienced significantly less stomach pain and discomfort than those who received placebo .
RESULTS	Of those same 146 participants , 114 subjects reported gas and bloating during screening .
RESULTS	Similarly , subjects who received Aliva experienced significantly less gas and bloating from 2 h [ 95 % CI : -1.7 - ( -0.39 ) , P = 0.030 ] through 5 d ( 95 % CI : -2.0 -0.42 , P = 0.005 ) compared with the placebo arm .
CONCLUSIONS	In this double-blind , randomized clinical study , subjects with acute gastroenteritis receiving Aliva prebiotic showed significant and sustained improvement of multiple symptoms vs those receiving placebo .

###24708472
BACKGROUND	Recent studies have demonstrated that mesenchymal stem cells ( MSCs ) modulate the immune response and reduce lung injury in animal models .
BACKGROUND	Currently , no clinical studies of the effects of MSCs in acute respiratory distress syndrome ( ARDS ) exist .
BACKGROUND	The objectives of this study were first to examine the possible adverse events after systemic administration of allogeneic adipose-derived MSCs in ARDS patients and second to determine potential efficacy of MSCs on ARDS .
METHODS	Twelve adult patients meeting the Berlin definition of acute respiratory distress syndrome with a PaO2/FiO2 ratio of < 200 were randomized to receive allogeneic adipose-derived MSCs or placebo in a 1:1 fashion .
METHODS	Patients received one intravenous dose of 1 106 cells/kg of body weight or saline .
METHODS	Possible side effects were monitored after treatment .
METHODS	Acute lung injury biomarkers , including IL-6 , IL-8 and surfactant protein D ( SP-D ) , were examined to determine the effects of MSCs on lung injury and inflammation .
RESULTS	There were no infusion toxicities or serious adverse events related to MSCs administration and there were no significant differences in the overall number of adverse events between the two groups .
RESULTS	Length of hospital stay , ventilator-free days and ICU-free days at day 28 after treatment were similar .
RESULTS	There were no changes in biomarkers examined in the placebo group .
RESULTS	In the MSCs group , serum SP-D levels at day 5 were significantly lower than those at day 0 ( p = 0.027 ) while the changes in IL-8 levels were not significant .
RESULTS	The IL-6 levels at day 5 showed a trend towards lower levels as compared with day 0 , but this trend was not statistically significant ( p = 0.06 ) .
CONCLUSIONS	Administration of allogeneic adipose-derived MSCs appears to be safe and feasible in the treatment of ARDS .
CONCLUSIONS	However , the clinical effect with the doses of MSCs used is weak , and further optimization of this strategy will probably be required to reach the goal of reduced alveolar epithelial injury in ARDS .
BACKGROUND	Clinical trials.gov , NCT01902082 .

###25186211
OBJECTIVE	Research in health communication has shown that narratives contribute more positively to changing health behaviors than informational messages .
OBJECTIVE	The main purposes of this study were to examine and to compare the effects of two messages promoting physical activity , one narrative and the other informational , on the perceptions and behavioral intentions of cancer patients .
METHODS	A total of 158 women with breast cancer , undergoing chemotherapy and sedentary , were assigned to read the testimony of a breast cancer survivor who had been physically active during and after treatment ( TE group ) , a content-equivalent message composed of expert recommendations about physical activity in breast cancer patients ( RE group ) , or no message ( control group ) .
RESULTS	Source trust was higher in TE group than RE group ( p < 0.001 ) .
RESULTS	Exercise self-efficacy and exercise intention were higher in TE group than RE and control groups ( p < 0.001 ) .
RESULTS	However , scores in RE group were higher than those of TE group for beliefs about exercise benefits ( p < 0.001 ) and lower than those of TE and control groups for beliefs about exercise risks ( p < 0.001 ) .
RESULTS	Source trust , exercise self-efficacy , and beliefs about exercise benefits and risks mediated the relationship between the message and exercise intention .
CONCLUSIONS	The results suggest that narratives may be more effective in improving perceived physical abilities and involvement in physical activity , whereas informational messages seem to be more appropriate to convey the benefits and the absence of risks related to physical activity .

###24225126
BACKGROUND	The aim of this study was to investigate etomidate administration with or without flumazenil in autistic children who underwent intrathecal transplantation of stem cells by lumbar puncture .
METHODS	Forty autistic children aged 2-12 , who were scheduled for stem cell transplantation via lumbar puncture under anesthesia , were randomized for a double-blind study .
METHODS	The children were randomly assigned to two groups : the flumazenil group ( group F , n = 20 ) and the etomidate group ( group E , n = 20 ) .
METHODS	All children received 0.2 mg/kg of etomidate .
METHODS	In the case of inadequate anesthesia , patients received repeated doses of 0.1 mg/kg of etomidate until reaching deep sedation .
METHODS	After operation , children in group F were given flumazenil ( 0.01 mg/kg ) and children in group E received placebo .
METHODS	Heart rate ( HR ) , mean arterial pressure , oxygen saturation , respiratory rate , the Ramsay sedation score ( RSS ) , and recovery time of all children were continuously monitored and recorded during the entire procedure .
RESULTS	After anesthesia , blood pressure and HR measurements were not significantly changed in both groups compared with the baseline .
RESULTS	There were no respiratory depression , bradycardia , hypotension , nausea , and vomiting .
RESULTS	Five patients complained of pain on the site of injection .
RESULTS	Myoclonus occurred in seven patients .
RESULTS	Recovery time in group F was significantly shorter than in group E ( p < 0.001 ) , and after the injection of flumazenil , RSS in group F significantly decreased than in group E.
RESULTS	There were no significant differences in operation time .
RESULTS	Physician satisfaction in both groups was similar .
CONCLUSIONS	Etomidate resulted in stable hemodynamic responses and relatively less adverse effects , and flumazenil antagonized the anesthetic effect of etomidate ; thus , etomidate with flumazenil is suitable for performing stem cell transplantation in autistic children .

###25182605
OBJECTIVE	To evaluate the effects of heated humidified ventilation on mucociliary function during general anaesthesia .
METHODS	Male patients ( ASA physical status 1 or 2 ) , scheduled for elective radical retropubic prostatectomy , were allocated to receive sevoflurane general anaesthesia with conventional or heated humidified ventilation .
METHODS	Bronchial mucus transport velocity was assessed via fibreoptic bronchoscope and methylene blue dye at 3h after induction of anaesthesia .
RESULTS	Median ( SE ) bronchial mucus transport velocity was significantly higher in the heated humidified group ( n = 26 ) than the conventional ventilation group ( n = 24 ) ( 1.7 [ 0.3 ] mm/min vs 0.9 [ 0.1 ] mm/min ) .
CONCLUSIONS	Heated humidified ventilation effectively maintains mucociliary clearance of patients during sevoflurane general anaesthesia .

###24708702
BACKGROUND	Babies born after midtrimester preterm prelabour rupture of membranes ( PPROM ) are at risk to develop neonatal pulmonary hypoplasia .
BACKGROUND	Perinatal mortality and morbidity after this complication is high .
BACKGROUND	Oligohydramnios in the midtrimester following PPROM is considered to cause a delay in lung development .
BACKGROUND	Repeated transabdominal amnioinfusion with the objective to alleviate oligohydramnios might prevent this complication and might improve neonatal outcome .
METHODS	Women with PPROM and persisting oligohydramnios between 16 and 24 weeks gestational age will be asked to participate in a multi-centre randomised controlled trial .
METHODS	random allocation to ( repeated ) abdominal amnioinfusion ( intervention ) or expectant management ( control ) .
METHODS	The primary outcome is perinatal mortality .
METHODS	Secondary outcomes are lethal pulmonary hypoplasia , non-lethal pulmonary hypoplasia , survival till discharge from NICU , neonatal mortality , chronic lung disease ( CLD ) , number of days ventilatory support , necrotizing enterocolitis ( NEC ) , periventricular leucomalacia ( PVL ) more than grade I , severe intraventricular hemorrhage ( IVH ) more than grade II , proven neonatal sepsis , gestational age at delivery , time to delivery , indication for delivery , successful amnioinfusion , placental abruption , cord prolapse , chorioamnionitis , fetal trauma due to puncture .
METHODS	The study will be evaluated according to intention to treat .
METHODS	To show a decrease in perinatal mortality from 70 % to 35 % , we need to randomise two groups of 28 women ( two sided test , - error 0.2 and - error 0.05 ) .
CONCLUSIONS	This study will answer the question if ( repeated ) abdominal amnioinfusion after midtrimester PPROM with associated oligohydramnios improves perinatal survival and prevents pulmonary hypoplasia and other neonatal morbidities .
CONCLUSIONS	Moreover , it will assess the risks associated with this procedure .
BACKGROUND	NTR3492 Dutch Trial Register ( http://www.trialregister.nl ) .

###25174865
BACKGROUND	Aiming at partly controlled asthma ( PCa ) instead of controlled asthma ( Ca ) might decrease asthma medication use .
BACKGROUND	Biomarkers , such as the fraction of exhaled nitric oxide ( Feno ) , allow further tailoring of treatment .
OBJECTIVE	We sought to assess the cost-effectiveness and clinical effectiveness of pursuing PCa , Ca , or Feno-driven controlled asthma ( FCa ) .
METHODS	In a nonblind , pragmatic , cluster-randomized trial in primary care , adults ( 18-50 years of age ) with a doctor 's diagnosis of asthma who were prescribed inhaled corticosteroids were allocated to one of 3 treatment strategies : ( 1 ) aiming at PCa ( Asthma Control Questionnaire [ ACQ ] score < 1.50 ) ; ( 2 ) aiming at Ca ( ACQ score < 0.75 ) ; and ( 3 ) aiming at FCa ( ACQ score < 0.75 and Feno value < 25 ppb ) .
METHODS	During 12 months ' follow-up , treatment was adjusted every 3 months by using an online decision support tool .
METHODS	Outcomes were incremental cost per quality-adjusted life year gained , asthma control ( ACQ score ) , quality of life ( Asthma Quality of Life Questionnaire score ) , asthma medication use , and severe exacerbation rate .
RESULTS	Six hundred eleven participants were allocated to the PCa ( n = 219 ) , Ca ( n = 203 ) , or FCa ( n = 189 ) strategies .
RESULTS	The FCa strategy improved asthma control compared with the PCa strategy ( P < .02 ) .
RESULTS	There were no differences in quality of life ( P .36 ) .
RESULTS	Asthma medication use was significantly lower for the PCa and FCa strategies compared with the Ca strategy ( medication costs : PCa , $ 452 ; Ca , $ 551 ; and FCa , $ 456 ; P .04 ) .
RESULTS	The FCa strategy had the highest probability of cost-effectiveness at a willingness to pay of $ 50,000 / quality-adjusted life year ( 86 % ; PCa , 2 % ; Ca , 12 % ) .
RESULTS	There were no differences in severe exacerbation rate .
CONCLUSIONS	A symptom - plus Feno-driven strategy reduces asthma medication use while sustaining asthma control and quality of life and is the preferred strategy for adult asthmatic patients in primary care .

###24857271
OBJECTIVE	To determine the feasibility of a novel low-barrier-to-entry image guidance system .
METHODS	Initially a randomized crossover study was performed to establish the interface ( iPad or 3-dimensional mouse ) that minimized both the amount of time required to perform a manual image registration and the error of that registration .
METHODS	A subsequent clinical feasibility study was undertaken on 5 patients undergoing robot-assisted partial nephrectomy .
METHODS	Randomized crossover study primary outcomes were time to task completion , NASA-Task Load Index score , and alignment error ( translational and rotational ) .
METHODS	The Mann-Whitney U test was used to compare groups .
METHODS	Surgeon feedback was sought when assessing the system in a clinical setting .
RESULTS	In the initial randomized crossover study , the iPad-based system was able to achieve adequate alignment accuracy ( Frobenius norm of 0.3 ; total error of 20.8 mm ) in significantly less time ( 33 seconds ; P < .01 ) than the 3-dimensional mouse interface .
RESULTS	The platform received good feedback from the operating surgeon in all instances with the surgeon commenting particularly on the improved appreciation of hilar vascular anatomy .
CONCLUSIONS	In this study , we have demonstrated the feasibility of a `` low-barrier-to-entry '' image guidance system in a clinical setting .
CONCLUSIONS	The system was able to achieve swift and sufficiently accurate alignment , with little impact on the surgical workflow .

###25116481
BACKGROUND	BMS-820836 is a novel antidepressant that selectively inhibits the reuptake of serotonin , norepinephrine , and dopamine .
OBJECTIVE	This Phase I study assessed safety , tolerability , and pharmacokinetics of multiple daily doses of BMS-820836 in healthy subjects .
OBJECTIVE	Central serotonin transporter ( SERT ) and dopamine transporter ( DAT ) occupancy were assessed using positron emission tomography and [ ( 11 ) C ] MADAM or [ ( 11 ) C ] PE2I , respectively .
METHODS	Fifty-seven healthy volunteers were enrolled in this double-blind , placebo-controlled , ascending multiple-dose study ( ClincalTrials.gov identifier : NCT00892840 ) .
METHODS	Eight participants in seven dose cohorts received oral doses of BMS-820836 ( 0.1-4mg ) or placebo for 14days to assess safety , tolerability , and pharmacokinetics .
METHODS	Additionally , SERT and DAT occupancies were evaluated in 4-8 subjects per cohort at 8h post-dose on Day 10 and 24h post-dose on Day 15 at anticipated steady-state conditions .
RESULTS	Most adverse events were mild to moderate ; there were no serious safety concerns .
RESULTS	Median maximum concentrations of BMS-820836 were observed at 4.0-5 .5 h post-dose ; estimated elimination half-life was 44-74h .
RESULTS	About 80 % striatal SERT occupancy was achieved after multiple doses of 0.5 mg BMS-820836 at both 8 and 24h post-dose .
RESULTS	Striatal DAT occupancy ranged between 14 % and 35 % at 8h post-dose with a slight decline at 24h post-dose .
CONCLUSIONS	Multiple daily doses of up to 4mg BMS-820836 appeared to be generally safe and well tolerated in a healthy population .
CONCLUSIONS	SERT and DAT occupancies were in a range associated with therapeutic efficacy of antidepressants .
CONCLUSIONS	Together with the pharmacokinetic profile of BMS-820836 , the occupancy data support once-daily administration .

###25603659
BACKGROUND	Stroke is a devastating complication of coronary artery bypass grafting ( CABG ) .
BACKGROUND	This study was carried out with the aim that the development of off pump coronary artery surgery decreases the incidence/adverse outcome due to extra corporeal circulation .
METHODS	The data utilized in this study was extracted from a randomized controlled trial that was conducted from January 2006 to March 2007 at Punjab Institute of Cardiology .
METHODS	One hundred patients were included in ` on pump ' group-A , and 100 patients in ` off pump ' group-B .
RESULTS	The mean age of the patients in group-A was 53.51 9.96 years and in group-B it was 51.59 10.30 years .
RESULTS	Renal failure occurred in 21 % patients of group-A as compared to 10 % of group-B while Acute Myocardial Infarction occurred in significantly higher number of patients in group-B ( 11 % ) as compared to group-A ( 2 % ) .
RESULTS	Off pump was associated with significant decrease in rate of stroke 1.5 % as compared to on pump 3.5 % .
RESULTS	similarly there was decreased in the risk of deaths after stroke 0 % as compared to on pump 1.5 % mortality after stroke .
RESULTS	In group A 6 ( 3.5 % ) patients developed stroke where as in group-B 2 ( 1.5 % ) patients developed stroke out of these 6 patients there were 2 mortalities after stroke in group-A while in group-B there was no mortality after stroke within 30 days postoperatively .
CONCLUSIONS	Off pump CABG is associated with significantly decreased rate of stroke in comparison with the on-pump CABG .

###24661011
BACKGROUND	Early detection of right ventricular ( RV ) and left ventricular ( LV ) dysfunction in patients with repaired tetralogy of Fallot ( TOF ) is essential because dysfunction is correlated with a poor clinical outcome .
BACKGROUND	The aim of this study was to assess RV and LV function in asymptomatic children with repaired TOF by two-dimensional ultrasound speckle tracking echocardiography ( STE ) .
METHODS	Fifty-six asymptomatic children with a preserved biventricular ejection fraction ( EF ) after repair of TOF and 35 healthy control subjects were studied .
METHODS	RV and LV strain and strain rate were measured by STE. RVEF and pulmonary regurgitation ( PR ) were assessed using cardiac magnetic resonance imaging .
RESULTS	Compared with the control subjects , RV regional longitudinal strain and strain rate and global longitudinal strain ( GLS ) and strain rate ( GLSR ) were impaired in children with repaired TOF .
RESULTS	Likewise , LV circumferential and radial strain and strain rate were reduced in patients with TOF .
RESULTS	In contrast , longitudinal strain and strain rate did not differ between the groups .
RESULTS	RV and LV GLSR were correlated with postoperative follow-up period ( r1 = -0.44 ; r2 = -0.48 ) .
RESULTS	RV GLS and GLSR were associated with RVEF ( r1 = 0.64 ; r2 = 0.60 ) and PR ( r1 = -0.48 ; r2 = -0.49 ) .
RESULTS	LV circumferential strain rate was related to PR ( r = -0.45 ) .
CONCLUSIONS	STE can identify abnormalities that may represent early impairment of RV and LV systolic function in postoperative TOF patients with a preserved EF .
CONCLUSIONS	PR is associated with decreased biventricular performance in repaired patients .
CONCLUSIONS	STE-derived strain and strain rate may be useful indices for detecting the early deterioration of biventricular performance in patients with TOF .

###25567119
BACKGROUND	Although mouse brain-derived , inactivated Japanese encephalitis vaccines ( JE-MBs ) have been successfully used for a long time , potential rare neurological complications have prompted the development of a Vero cell culture-derived inactivated vaccine ( JE-VC ) .
BACKGROUND	In a phase III clinical study , we aimed to compare the safety and immunogenicity of a JE-VC , KD-287 with a JE-MB , JEV-GCC , in children .
METHODS	In this multicenter , double-blinded , randomized controlled trial , the study population consisted of 205 healthy Korean children aged 12-23 months .
METHODS	Each subject was subcutaneously vaccinated with either KD-287 or JEV-GCC twice at an interval of 2weeks and then vaccinated once 12months after the second vaccination .
METHODS	Neutralizing antibodies were measured by the plaque reduction neutralization test using the homologous and heterologous , as a post hoc analysis , challenge virus strains .
RESULTS	The three-dose regimen of KD-287 showed a comparable safety profile with JEV-GCC except higher incidence of fever after the first dose ( 30.4 % and 14.7 % , respectively ) .
RESULTS	Most of the fever was mild degree ( 61.3 % and 66.7 % , respectively ) .
RESULTS	KD-287 fulfilled the non-inferiority criteria for seroconversion rate ( SCR ) and geometric mean titer ( GMT ) of the neutralizing antibody , which were the primary endpoints , at 4weeks after the third vaccination ( 95 % CI : -1.00 , 3.10 for the SCR difference and 10.8 , 17.6 for the GMT ratio ) .
RESULTS	The SCRs of KD-287 were all 100 % and the GMTs were higher in the KD-287 group than in the JEV-GCC group after the second vaccination and before and after the third vaccination ( GMT ratio : 5.59 , 20.13 , and 13.79 , respectively , p < 0.001 in all ) .
RESULTS	GMTs were higher in the KD-287 group in the heterologous analysis also ( GMT ratio : 4.05 , 5.15 , and 4.19 , respectively , p < 0.001 in all ) .
CONCLUSIONS	This study suggests that the KD-287 , a JE-VC is as safe as and may be more effective than the licensed MB-derived vaccine .
CONCLUSIONS	KD-287 could thus be useful as a second-generation vaccine and substitute for the current JE-MB vaccine in Korean children .
BACKGROUND	ClinicalTrials.gov : NCT01150942 .

###24273972
OBJECTIVE	To evaluate the clinical efficacy of acupuncture combined single photon emission computed tomography ( SPECT ) in treating coronary heart disease ( CHD ) and its effect on the myocardial ischemia/perfusion and the recovery of heart functions .
METHODS	Totally fifty-nine patients with confirmed CHD were randomly assigned to two groups , the acupuncture group ( 32 cases ) and the nitroglycerine group ( 27 cases ) .
METHODS	Patients in the acupuncture group were electro-acupunctured at bilateral Neiguan ( PC6 ) and Xinshu ( BL15 ) for 30 min with the frequency of 2/15 Hz and the current strength 9 - 18 mA after myocardial imaging induced by routine exercises or drug load .
METHODS	99mTc-MIBI 370 MBq was injected 15 min after needling .
METHODS	The myocardial perfusion imaging was performed immediately after needling .
METHODS	99mTc-MIBI740 MBq was injected to those in the nitroglycerine group during routine exercises or drug load .
METHODS	The myocardial perfusion imaging was performed 5 min after injection .
METHODS	Patients were asked to sublingual administration of nitroglycerine 1 mg after the myocardial perfusion imaging was completed .
METHODS	99mTc-MIBI 370 MBq was intravenously injected 5 min later , and myocardial perfusion imaging was performed 5 min after injection .
RESULTS	There was statistical difference in changes of radioactive uptake between before and after treatment in the two groups ( P < 0.05 , P < 0.01 ) .
RESULTS	Both acupuncture and buccal administration of nitroglycerine could increase the blood perfusion of ischemic myocardium .
RESULTS	But there was no statistical difference in the improvement of ischemic myocardial cells ( t = 1.57 , P > 0.05 ) .
CONCLUSIONS	Using SPECT could clearly display therapeutic effects of acupuncture on CHD , thus providing a new visible research method for CHD studies .

###25362669
BACKGROUND	It is unknown if disposable electrocardiographic lead wires ( ECG-LWs ) reduce infection rates compared with cleaned , reusable lead wires .
OBJECTIVE	To compare infection rates in intensive care unit ( ICU ) patients receiving disposable versus reusable ECG-LWs .
METHODS	Matched adult ICUs were randomly assigned to disposable or reusable ECG-LWs .
METHODS	Outcomes were bloodstream infection , ventilator-associated pneumonia , and chest surgical site infections .
METHODS	Patients ' characteristics and infections were collected from hospital databases .
METHODS	Event rates were described by using total counts and rates per 100 patient days and were compared between groups by using generalized linear mixed-effect models weighted by patients ' ICU length of stay .
RESULTS	Overall , 4056 patients from 6 ICUs received disposable and 3184 patients from 5 ICUs received reusable ECG-LWs .
RESULTS	The characteristics of the 2 groups were similar , except patients receiving disposable ECG-LWs were less likely to be discharged home ( P = .03 ) and had more comorbid conditions ( P = .002 ) .
RESULTS	Overall infection rates did not differ between ECG-LW groups , between groups in matched ICUs , between groups by infection type , or when only patients with ICU stays longer than 48 hours were considered ( 2578 cases ) .
RESULTS	In multivariate analyses , infection rates did not differ between all patients in ECG-LW groups or for patients with ICU stays beyond 48 hours ( both P = .10 ) .
CONCLUSIONS	No difference was observed in infection rates of ICU patients receiving disposable versus reusable ECG-LWs .

###24296958
BACKGROUND	The safety and efficacy of dexmedetomidine during laser in situ keratomileusis ( LASIK ) in stressed patients under topical anesthesia has not been fully investigated .
METHODS	We randomized 30 adult patients with ametropia , with a Self-Rating Anxiety Scale score greater than 50 , who were undergoing LASIK to receive dexmedetomidine ( DEX group ) , propofol ( P group ) , or placebo .
METHODS	No differences in baseline characteristics were observed between the groups .
METHODS	In the DEX group , dexmedetomidine was loaded ( 0.3 g/kg ) before superficial anesthesia for eye surgery .
METHODS	Mean arterial pressure , heart rate ( HR ) , oxygen saturation ( SpO2 ) , bispectral index ( BIS ) monitoring , and end-tidal CO2 were recorded before infusion ( baseline ) and every 5 minutes after loading of the study drugs .
METHODS	The degree of sedation was evaluated using the Ramsay Sedation Scale by an anesthesiologist who was unaware of the type of sedative used .
METHODS	The satisfaction of the patients and surgeon was assessed immediately after surgery using a 7-point Likert-like verbal rating scale .
RESULTS	Significantly lower HR was observed over time in the DEX group compared with the P group .
RESULTS	No significant differences in SpO2 were observed between the groups .
RESULTS	Bispectral index scores decreased at 10 , 15 , and 20 minutes after infusion .
RESULTS	The surgeon 's satisfaction scores were higher in the DEX group than in the P group .
RESULTS	Recovery times were longer in DEX group than in the P group .
CONCLUSIONS	Dexmedetomidine in conjunction with topical anesthesia offered better conscious sedation for nervous patients during LASIK , but these patients required a longer recovery period .

###25613938
OBJECTIVE	To measure serum levels of bevacizumab and to compare serum levels of free vascular endothelial growth factor ( VEGF ) and insulin-like growth factor-1 ( IGF-1 ) in infants who were treated with either intravitreal injection of bevacizumab ( IVB ) or laser for type 1 retinopathy of prematurity ( ROP ) .
METHODS	Twenty-four infants with type 1 ROP were randomized into three treatment groups : IVB at 0.625 mg per eye per dose , IVB at 0.25 mg per eye per dose , and laser .
METHODS	Blood samples were collected prior to treatment and on posttreatment days 2 , 14 , 42 , and 60 .
METHODS	Weekly body weights were documented from birth until 60 days post treatment .
METHODS	Serum levels of bevacizumab , free VEGF , and IGF-1 were measured with enzyme-linked immunosorbent assay ( ELISA ) .
RESULTS	Serum bevacizumab was detected 2 days after the injection , peaked at 14 days , and persisted for up to 60 days with half-life of 21 days .
RESULTS	Area under the curve ( AUC ) analysis showed that systemic exposure to bevacizumab was variable among the subjects and was dose dependent .
RESULTS	Serum free VEGF levels decreased in all three subgroups 2 days post treatment , with more significant reductions found in both IVB-treated groups , P = 0.0001 .
RESULTS	Serum IGF-1 levels were lower in both IVB-treated groups .
CONCLUSIONS	Clearance of bevacizumab from the bloodstream in premature infants takes at least 2 months .
CONCLUSIONS	Although serum free VEGF levels decreased following either laser or bevacizumab treatment , the reductions were more significant in the IVB-treated groups .
CONCLUSIONS	Potential long-term effects of systemic exposure to bevacizumab in infants need to be studied further .

###24347351
BACKGROUND	Hypotension during spinal anesthesia is a serious complication in elderly patients .
BACKGROUND	We evaluated the effect of glycopyrrolate on hypotensive responses in elderly patients undergoing spinal anesthesia .
METHODS	Sixty-six patients older than 60 yr of age scheduled for elective surgery with spinal anesthesia were included in the study .
METHODS	They received either glycopyrrolate 0.2 mg ( group G ) or normal saline ( group C ) intramuscularly 15 min before spinal anesthesia .
METHODS	The following outcomes were evaluated after the induction of spinal anesthesia : the incidence of hypotension and bradycardia , the ephedrine requirement , mean arterial pressure , heart rate , and the incidence of nausea and vomiting .
RESULTS	Twenty-three of 33 ( 70.0 % ) patients in group C experienced hypotension compared with nine of 33 ( 27.3 % ) patients in group G ( difference = 42.7 % ; 95 % confidence interval [ CI ] : 18.4 to 60.2 ; P = 0.001 ) .
RESULTS	The median [ interquartile range ] amount of ephedrine required was 5 [ 0-15 ] mg in group C compared with 0 [ 0-5 ] mg in group G ( difference = 5.0 mg ; 95 % CI : 2.7 to 7.3 ; P = 0.001 ) .
RESULTS	Nine ( 27.3 % ) patients in group C experienced nausea and vomiting compared with 2 ( 6.1 % ) in group G ( difference = 21.2 % ; 95 % CI : 3.0 to 38.7 ; P = 0.044 ) .
RESULTS	Three ( 9.1 % ) patients in group C experienced bradycardia compared with 1 ( 3.0 % ) patient in group G ( difference = 6.1 % ; 95 % CI : -7.6 to 20.8 ; P = 0.613 ) .
CONCLUSIONS	Prophylactic intramuscular glycopyrrolate reduced the occurrence and severity of hypotensive responses , the requirement for ephedrine , and the incidence of nausea and vomiting in elderly patients undergoing spinal anesthesia .
CONCLUSIONS	The trial was registered at the Clinical Research Information Service , Republic of Korea ( KCT0000556 ) .

###25111880
OBJECTIVE	Studies have shown that bisphosphonates may have antitumor and antimetastatic properties .
OBJECTIVE	Recently , observational studies have suggested a possible protective effect of bisphosphonates on breast cancer , but the effect of bisphosphonate use on risk of breast cancer has not been tested in randomized trials .
OBJECTIVE	To assess the relationship of postmenopausal breast cancer incidence and bisphosphonate use using data from 2 randomized ( 1:1 ) , double-blind , placebo-controlled trials .
METHODS	The Fracture Intervention Trial ( FIT ) randomly assigned 6459 women aged 55 to 81 years to alendronate or placebo for a mean follow-up of 3.8 years .
METHODS	The Health Outcomes and Reduced Incidence With Zoledronic Acid Once Yearly-Pivotal Fracture Trial ( HORIZON-PFT ) randomly assigned 7765 women aged 65 to 89 years to annual intravenous zoledronic acid or placebo for a mean follow-up of 2.8 years .
METHODS	Data were collected at clinical centers in the United States ( FIT and HORIZON-PFT ) and in Asia and the Pacific , Europe , North America , and South America ( HORIZON-PFT ) .
METHODS	Women , in either study , with recurrent breast cancer or who reported a history of breast cancer were excluded from analyses .
METHODS	In each trial , a blinded review was conducted of each cancer adverse event report to verify incident invasive breast cancer cases .
METHODS	The primary analysis compared events in the active vs placebo group using a log-rank test .
METHODS	Alendronate vs placebo ( FIT ) or zoledronic acid vs placebo ( HORIZON-PFT ) .
METHODS	Hazard ratio for incident breast cancer in the bisphosphonate treatment group compared to the placebo group .
RESULTS	There was no significant difference in the rate of breast cancer in FIT : 1.5 % ( n = 46 ) in the placebo group and 1.8 % ( n = 57 ) in the alendronate group ( hazard ratio [ HR ] , 1.24 [ 95 % CI , 0.84-1 .83 ] ) .
RESULTS	In HORIZON-PFT , there was also no significant difference : 0.8 % ( n = 29 ) in the placebo group and 0.9 % ( n = 33 ) in the zoledronic acid group ( HR , 1.15 [ 95 % CI , 0.70-1 .89 ] ) .
RESULTS	There was also no significant difference when the data from FIT and HORIZON-PFT were pooled ( HR , 1.20 [ 95 % CI , 0.89-1 .63 ] ) .
CONCLUSIONS	These 2 randomized clinical trials do not support the findings from observational research .
CONCLUSIONS	Contrary to the results from observational studies , we found that 3 to 4 years of bisphosphonate treatment did not decrease the risk of invasive postmenopausal breast cancer .
BACKGROUND	clinicaltrials.gov Identifier : NCT00049829 ( HORIZON-PFT ) .

###25432081
OBJECTIVE	To evaluate pazopanib eye drops in subjects with active subfoveal choroidal neovascularization ( CNV ) secondary to age-related macular degeneration ( AMD ) .
METHODS	Multicountry , randomized , parallel-group , double-masked , active and placebo-controlled , dose-ranging study of eye drops .
METHODS	A total of 510 subjects ( 93 % white ; 58 % female ; mean age , 75.3 years ) whose AMD was previously managed by anti-vascular endothelial growth factor intravitreal injections .
METHODS	Treatments administered for 52 weeks included placebo eye drops instilled 4 times daily ( n = 73 ) ; pazopanib 5 mg/ml instilled 3 ( n = 72 ) or 4 times daily ( n = 74 ) ; pazopanib 10 mg/ml instilled 2 ( n = 73 ) , 3 ( n = 73 ) , or 4 times daily ( n = 72 ) ; or ranibizumab injection administered once every 4 weeks ( n = 73 ) .
METHODS	In addition , for all eye drop treatment groups , open-label ranibizumab was administered as needed .
METHODS	The main outcome measures were best-corrected visual acuity ( BCVA ) and injection frequency assessed at week 52 .
METHODS	Safety was assessed every 4 weeks and pazopanib plasma concentrations were determined at weeks 4 and 24 .
RESULTS	At week 52 , pazopanib , with allowance for as-needed ranibizumab injections , was noninferior to monthly ranibizumab as well as to as-needed ranibizumab administered with placebo eye drops in maintaining BCVA ( estimated BCVA gains of 0.3-1 .8 vs. 1.4 vs. 0.2 letters , respectively ) .
RESULTS	Pazopanib treatment did not reduce as-needed ranibizumab injections by 50 % ( prespecified efficacy criterion ) .
RESULTS	At week 52 , there were no clinically meaningful changes from baseline in retinal thickness or morphology , CNV size , or lesion characteristics on optical coherence tomography or fluorescein angiography .
RESULTS	Complement factor H genotype had no effect on the responses to pazopanib and/or ranibizumab ( BCVA , injection rate , or optical coherence tomography/fluorescein angiography changes ) .
RESULTS	Steady-state concentrations of pazopanib in plasma seemed to be reached by week 4 .
RESULTS	The most common ocular adverse events related to pazopanib and ranibizumab were application site pain ( 3 % ) and injection site hemorrhage ( 1 % ) , respectively .
RESULTS	No treatment-related serious adverse events were reported .
CONCLUSIONS	Pazopanib was well tolerated .
CONCLUSIONS	Daily pazopanib eye drops in neovascular AMD subjects did not result in therapeutic benefit beyond that obtained with ranibizumab alone .

###24608207
OBJECTIVE	Evaluate the effect on the application of low level laser therapy , in patients that have been previously intervened with a sagittal ramus split osteotomy and present neurosensory impairment due to this surgery , compared with placebo .
METHODS	This preliminary study is a randomized clinical trial , with an experimental group ( n = 17 ) which received laser light and a control group ( n = 14 ) , placebo .
METHODS	All participants received laser applications , divided after surgery in days 1 , 2 , 3 , 5 , 10 , 14 , 21 and 28 .
METHODS	Neurosensory impairment was evaluated clinically with 5 tests ; visual analog scale ( VAS ) for pain and sensitivity , directional and 2 point discrimination , thermal discrimination , each one of them performed before and after surgery on day 1 , and 1 , 2 and 6 months .
METHODS	Participants and results evaluator were blinded to intervention .
METHODS	Variables were described with absolute frequencies , percentages and medians .
METHODS	Ordinal and dichotomous variables were compared with Mann Whitney 's and Fisher 's test respectively .
RESULTS	RESULTS demonstrate clinical improvement in time , as well as in magnitude of neurosensory return for laser group ; VAS for sensitivity reached 5 ( normal ) , 10 participants recovered initial values for 2 point discrimination ( 62,5 % ) and 87,5 % recovered directional discrimination at 6 months after surgery .
RESULTS	General VAS for sensitivity showed 68,75 % for laser group , compared with placebo 21,43 % ( p-value = ( 0.0095 ) ) .
RESULTS	Left side sensitivity ( VAS ) showed 3.25 and 4 medians for placebo and laser at 2 months , respectively ( p-value = ( 0.004 ) ) .
CONCLUSIONS	Low-level laser therapy was beneficial for this group of patients on recovery of neurosensory impairment of mandibular nerve , compared to a placebo .

###24258152
OBJECTIVE	The aim of this study was to explore the influence of a half-course tourniquet strategy on the peri-operative blood loss and early functional recovery in primary total knee arthroplasty .
METHODS	A prospective clinical randomised controlled study was carried out in which 64 patients were equally divided into two groups : half-course group and whole-course group .
METHODS	A series of indicators were observed and recorded .
METHODS	These included operation time , peri-operative blood loss , visual analogue scale ( VAS ) score of the thigh or knee , limb swelling index , rehabilitation progress and occurrence of deep venous thrombosis cases .
RESULTS	There was no significant difference in operation time between the two groups .
RESULTS	The intra-operative blood loss was slightly more in the half-course group , while the difference was not significant .
RESULTS	The post-operative blood loss and calculated blood loss were less in the half-course group and the difference was significant .
RESULTS	The thigh VAS score , limb swelling and time intervals required for patients to achieve straight leg raises and 90 of knee flexion in the half-course group were better than in the whole-course group .
RESULTS	No case of symptomatic deep venous thrombosis happened in this study , while occult incidence of deep venous thrombosis happened in both groups , but no significant difference between the groups was confirmed .
CONCLUSIONS	The half-course tourniquet strategy could decrease the total peri-operative blood loss in primary total knee arthroplasty .
CONCLUSIONS	It was beneficial in helping patients to achieve earlier functional recovery by improving the pain experience and limb swelling early in the post-operative period .

###24285582
OBJECTIVE	To investigate the effect of extended-release ( ER ) niacin on the metabolism of high-density lipoprotein ( HDL ) apolipoprotein A-I ( apoA-I ) in men with type 2 diabetes mellitus on a background of optimal statin therapy .
RESULTS	Twelve men with type 2 diabetes mellitus were recruited for a randomized , crossover design trial .
RESULTS	Patients were randomized to rosuvastatin or rosuvastatin plus ER niacin for 12 weeks and then crossed over to the alternate therapy after a 3-week washout period .
RESULTS	Metabolic studies were performed at the end of each treatment period .
RESULTS	HDL apoA-I kinetics were measured after a standardized liquid mixed meal and a bolus injection of d3-leucine for 96 hours .
RESULTS	Compartmental analysis was used to model the data .
RESULTS	ER niacin significantly decreased plasma triglyceride , plasma cholesterol , non-HDL cholesterol , low-density lipoprotein cholesterol , and apoB ( all P < 0.05 ) and significantly increased HDL cholesterol and apoA-I concentrations ( P < 0.005 and P < 0.05 , respectively ) .
RESULTS	ER niacin also significantly increased HDL apoA-I pool size ( 6,088 292 versus 5,675 305 mg ; P < 0.001 ) , and this was attributed to a lower HDL apoA-I fractional catabolic rate ( 0.33 0.01 versus 0.37 0.02 pools/d ; P < 0.005 ) , with no significant changes in HDL apoA-I production ( 20.93 0.63 versus 21.72 0.85 mg/kg per day ; P = 0.28 ) .
CONCLUSIONS	ER niacin increases HDL apoA-I concentration in statin-treated subjects with type 2 diabetes mellitus by lowering apoA-I fractional catabolic rate .
CONCLUSIONS	The effect on HDL metabolism was independent of the reduction in plasma triglyceride with ER niacin treatment .
CONCLUSIONS	Whether this finding applies to other dyslipidemic populations remains to be investigated .

###25199877
BACKGROUND	The weaning period is critical for stress-related diseases and infections .
BACKGROUND	Currently , large amounts of therapeutic antimicrobials are used to treat infections in the livestock production , especially in piglets .
BACKGROUND	Phytogenic feed additives could provide a useful alternative .
BACKGROUND	We hypothesize , that components in agrimonia species which have been used successfully in humans to treat gastrointestinal infections could also improve the health of piglets .
BACKGROUND	We investigated the effects of Agrimonia procera ( AP ) on the growth performance of piglets and cytokine expression in isolated porcine peripheral blood mononuclear cells ( PBMC ) .
RESULTS	Here we show that piglets that received a diet with 0.56 g/kg AP for 6 weeks tended to ingest more food ( +5.1 % ; P < 0.10 ) , and were characterized by a higher nitrogen retention ( +9.6 % , P < 0.05 ) than the control group without AP treatment .
RESULTS	Data from a second experiment reveal that piglets fed a diet with 0.87 g/kg AP for 6 weeks had an improved food conversion ratio ( 1.46 0.04 ) compared to those that received none ( 1.54 0.08 ) or 8.7 g/kg AP ( 1.60 0.08 ) with their diets ( P < 0.001 ) .
RESULTS	However , the food intake , daily weight gain and dry matter of feces were not affected by the AP treatment .
RESULTS	Treatment of PBMC for 1 and 6 h with AP extract ( APE ) reduced the mRNA abundance of tumor necrosis factor ( TNF ) ?
RESULTS	in cells challenged with lipopolysaccharides ( LPS ) but not in cells without LPS stimulation ( P < 0.05 ) .
RESULTS	The lower mRNA expression of TNF ?
RESULTS	was accompanied by a trend towards a lower release of TNF ?
RESULTS	from these cells ( P ?
RESULTS	= ?
RESULTS	0.067 ) .
RESULTS	After the treatment of PBMC with APE for 6 h , the relative mRNA concentration of interleukin ( IL ) -1 ?
RESULTS	declined ( P < 0.05 ) , whereas that of IL-10 remained unchanged .
RESULTS	Treatment of LPS-challenged PBMC for 20 h with varying concentrations of APE did not reveal any effect on cytokine expression and TNF ?
RESULTS	release .
CONCLUSIONS	The results indicate that low dosages of AP may improve the growth performance of piglets and seem to exert antiinflammatory effects in porcine immune cells challenged with LPS .

###25325498
OBJECTIVE	Forty-one percent of shift workers report dozing while driving .
OBJECTIVE	This study tested whether armodafinil improves driving simulator performance in subjects with shift work disorder ( SWD ) .
OBJECTIVE	A primary outcome was performance late in the shift when workers are typically driving home .
METHODS	Randomized , double-blind , crossover .
METHODS	During each 12-h test session ( 21:30 -09:30 ) , subjects were kept awake except for multiple sleep latency testing ( MSLT : 01:30 , 03:30 , 05:30 , and 07:30 ) .
METHODS	Subjective sleepiness ( Karolinska Sleepiness Scale , KSS ) , driving performance , and cognitive performance ( digit symbol substitution test and creativity on the Remote Associates Test , RAT ) were evaluated during the night shift and commute home times .
METHODS	Hospital-based sleep research laboratory .
METHODS	Twenty night workers ( age : 42.7 8.7 y , 17 F ) with excessive sleepiness ( 10 on the Epworth Sleepiness Scale ) , meeting International Classification of Sleep Disorders , Second Edition ( ICSD-2 ) criteria for SWD , and having no other medical conditions .
METHODS	Armodafinil ( 150 mg ) or placebo at ( 23:45 h ) on counterbalanced nights separated by 7-14 days .
RESULTS	Primary endpoints were driving simulator performance ( standard deviation of lateral position ( SDLP ) and off-road deviations ) with four sessions starting 3.25 h after drug administration , objective sleepiness ( MSLT ; 1.75 to 7.75 h post-drug ) , and creativity ( 5 h post-drug ) .
RESULTS	Significant effects of drug were observed for each driving measure ( P < 0.05 ) .
RESULTS	Armodafinil significantly improved SDLP for simulator sessions at 05:30 , 07:30 , and 09:30 , and off-road deviations at 7 h , 15 min and 9 h , 15 min post-drug ( P < 0.05 ) .
RESULTS	Armodafinil also improved objective sleepiness from 3.7 0.6 min to 9.7 5.2 min ( P < 0.001 ) and RAT score from 8.75 4.9 to 11.25 6.0 ( P < 0.005 ) .
CONCLUSIONS	Armodafinil 150 mg early in the night shift improves driving simulator performance in SWD .
CONCLUSIONS	Effects on sleepiness , cognition , and driving were found up to 9.5 h post-ingestion , during the critical time when many night workers are driving home .

###24461900
BACKGROUND	Postinfectious cough is common in primary care , but has no proven effective treatments .
BACKGROUND	Cysteinyl leukotrienes are involved in the pathogenesis of postinfectious cough and whooping cough ( pertussis ) .
BACKGROUND	We investigated the effectiveness of montelukast , a cysteinyl leukotriene receptor antagonist , in the treatment of postinfectious cough .
METHODS	In this randomised , placebo-controlled trial , non-smoking adults aged 16-49 years with postinfectious cough of 2-8 weeks ' duration were recruited from 25 general practices in England .
METHODS	Patients were tested for pertussis ( oral fluid anti-pertussis toxin IgG ) and randomly assigned ( 1:1 ) to montelukast 10 mg daily or image-matched placebo for 2 weeks .
METHODS	Patients chose whether to continue study drug for another 2 weeks .
METHODS	The randomisation sequence was computer-generated and stratified by general practice .
METHODS	Patients , health-care professionals , and researchers were masked to treatment allocation .
METHODS	Effectiveness was assessed with the Leicester Cough Questionnaire to measure changes in cough-specific quality of life ; the primary outcomes were changes in total score between baseline and two follow-up stages ( 2 weeks and 4 weeks ) .
METHODS	The primary analysis was by intention to treat with imputation by last observation carried forward .
METHODS	Recruitment closed on Sept 21 , 2012 , and follow-up has been completed .
METHODS	This trial is registered with EudraCT ( 2010-019647-19 ) , UKCRN Portfolio ( ID 8360 ) , and ClinicalTrials.gov ( NCT01279668 ) .
RESULTS	From April 13 , 2011 , to Sept 21 , 2012 , we randomly assigned 276 patients to montelukast ( n = 137 ) or placebo ( n = 139 ) .
RESULTS	70 ( 25 % ) patients had laboratory-confirmed pertussis .
RESULTS	Improvements in cough-specific quality of life occurred in both groups after 2 weeks ( montelukast : mean 27 , 95 % CI 22-33 ; placebo : 36 , 29-43 ) , but the difference between groups did not meet the minimum clinically important difference of 13 ( mean difference -09 , -17 to -004 , p = 004 ) .
RESULTS	This difference was not statistically significant in any sensitivity analyses .
RESULTS	After 2 weeks , 192 of 259 participants from whom data were available elected to continue study drug ( 99 [ 77 % ] of 129 participants on montelukast ; 93 [ 72 % ] of 130 on placebo ) .
RESULTS	After 4 weeks , there were no significant between-group differences in cough-specific quality of life improvement ( montelukast : 52 , 45-59 ; placebo : 59 , 51-67 ; mean difference -05 , -15 to 06 , p = 038 ) or adverse event rates ( 21 ( 15 % ) of 137 patients on montelukast reported one or more adverse events ; 31 ( 22 % ) of 139 on placebo ; p = 014 ) .
RESULTS	The most common adverse events reported were increased mucus production ( montelukast , n = 6 ; placebo , n = 2 ) , gastrointestinal disturbance ( montelukast , n = 3 ; placebo , n = 5 ) , and headache ( montelukast , n = 2 ; placebo , n = 6 ) .
RESULTS	One serious adverse event was reported ( placebo , n = 1 ) , which was unrelated to study drug ( shortness of breath and throat tightness after severe coughing bouts ) .
CONCLUSIONS	Montelukast is not an effective treatment for postinfectious cough .
CONCLUSIONS	However , the burden of postinfectious cough in primary care is high , making it an ideal setting for future antitussive treatment trials .
BACKGROUND	National Institute for Health Research School for Primary Care Research , UK .

###25203881
OBJECTIVE	Compare the feasibility and patient tolerance to either a clear fluid ( CF ) or low residue diet ( LRD ) started on postoperative day ( POD ) 1 after elective colorectal surgery .
BACKGROUND	Diet advancement after surgery traditionally starts gradually with liquids , on the basis of fears that early solid intake may increase nausea , vomiting , and overall complications .
BACKGROUND	A randomized controlled trial comparing LRD and CF on POD 1 was performed .
METHODS	111 elective colorectal surgery patients were randomized to CF ( n = 57 ) or LRD ( n = 54 ) .
METHODS	The primary end point was vomiting on POD 2 .
METHODS	Secondary endpoints included nausea score , days to flatus , length of hospital stay ( LOS ) , and postoperative morbidity .
RESULTS	Patient characteristics , surgical technique , intraoperative characteristics , and postoperative opioid use were similar between study arms .
RESULTS	CF versus LRD results were as follows : POD2 vomiting ( 28 % vs 14 % ; P = 0.09 ) , and significant increase in mean nausea score ( 4.7 vs 3.5 ; P = 0.01 ) , days to flatus ( 4.8 vs 3.7 days ; P = 0.04 ) , and LOS ( 7.0 vs 5.0 days ; P = 0.01 ) .
RESULTS	LOS remained significantly shorter even after adjusting for significant covariates ( laparoscopic technique , surgical site , postoperative comorbidity , stoma , and nasogastric tube ) with LRD patients having an adjusted 1.4-day decrease in LOS ( P < 0.01 ) .
RESULTS	There was no significant difference in postoperative morbidity between study arms .
RESULTS	Multivariate analysis of all secondary endpoints confirmed an overall significant improvement in outcomes for LRD vs CF ( P < 0.01 ) .
CONCLUSIONS	LRD , rather than CF , on POD1 after colorectal surgery is associated with less nausea , faster return of bowel function , and a shorter hospital stay without increasing postoperative morbidity .

###25533601
BACKGROUND	Skeletal muscle wasting in chronic kidney disease ( CKD ) is associated with morbidity and mortality .
BACKGROUND	Resistance exercise results in muscle hypertrophy in the healthy population , but is underinvestigated in CKD .
BACKGROUND	We aimed to determine the feasibility of delivering a supervised progressive resistance exercise program in CKD , with secondary aims to investigate effects on muscle size , strength , and physical functioning .
METHODS	Parallel randomized controlled feasibility study .
METHODS	Patients with CKD stages 3b to 4 were randomly assigned to the exercise ( n = 20 ; 11 men ; median age , 63 [ IQR , 57-65 ] years ; median estimated glomerular filtration rate , 28.5 [ IQR , 19.0-32 .0 ] mL/min/1 .73 m ( 2 ) ) or nonexercise control ( n = 18 ; 14 men ; median age , 66 [ IQR , 45-79 ] years ; estimated glomerular filtration rate , 20.5 [ IQR , 16.0-26 .0 ] mL/min/1 .73 m ( 2 ) ) group .
METHODS	Patients in the exercise group undertook an 8-week progressive resistance exercise program consisting of 3 sets of 10 to 12 leg extensions at 70 % of estimated 1-repetition maximum thrice weekly .
METHODS	Patients in the control group continued with usual physical activity .
RESULTS	Primary outcomes were related to study feasibility : eligibility , recruitment , retention , and adherence rates .
RESULTS	Secondary outcomes were muscle anatomical cross-sectional area , muscle volume , pennation angle , knee extensor strength , and exercise capacity .
METHODS	Two - and 3-dimensional ultrasonography of skeletal muscle , dynamometry , and shuttle walk tests at baseline and 8 weeks .
RESULTS	Of 2,349 patients screened , 403 were identified as eligible and 38 enrolled in the study .
RESULTS	33 ( 87 % ) completed the study , and those in the exercise group attended 92 % of training sessions .
RESULTS	No changes were seen in controls for any parameter .
RESULTS	Progressive resistance exercise increased muscle anatomical cross-sectional area , muscle volume , knee extensor strength , and exercise capacity .
CONCLUSIONS	No blinded assessors , magnetic resonance imaging not used to assess muscle mass , lack of a healthy control group .
CONCLUSIONS	This type of exercise is well tolerated by patients with CKD and confers important clinical benefits ; however , low recruitment rates suggest that a supervised outpatient-based program is not the most practical implementation strategy .

###24884877
BACKGROUND	Clinical practice guidelines have been widely developed and disseminated with the aim of improving healthcare processes and patient outcomes but the uptake of evidence-based practice remains haphazard .
BACKGROUND	There is a need to develop effective implementation methods to achieve large-scale adoption of proven innovations and recommended care .
BACKGROUND	Clinical networks are increasingly being viewed as a vehicle through which evidence-based care can be embedded into healthcare systems using a collegial approach to agree on and implement a range of strategies within hospitals .
BACKGROUND	In Australia , the provision of evidence-based care for men with prostate cancer has been identified as a high priority .
BACKGROUND	Clinical audits have shown that fewer than 10 % of patients in New South Wales ( NSW ) Australia at high risk of recurrence after radical prostatectomy receive guideline recommended radiation treatment following surgery .
BACKGROUND	This trial will test a clinical network-based intervention to improve uptake of guideline recommended care for men with high-risk prostate cancer .
METHODS	In Phase I , a phased randomised cluster trial will test a multifaceted intervention that harnesses the NSW Agency for Clinical Innovation ( ACI ) Urology Clinical Network to increase evidence-based care for men with high-risk prostate cancer following surgery .
METHODS	The intervention will be introduced in nine NSW hospitals over 10 months using a stepped wedge design .
METHODS	Outcome data ( referral to radiation oncology for discussion of adjuvant radiotherapy in line with guideline recommended care or referral to a clinical trial of adjuvant versus salvage radiotherapy ) will be collected through review of patient medical records .
METHODS	In Phase II , mixed methods will be used to identify mechanisms of provider and organisational change .
METHODS	Clinicians ' knowledge and attitudes will be assessed through surveys .
METHODS	Process outcome measures will be assessed through document review .
METHODS	Semi-structured interviews will be conducted to elucidate mechanisms of change .
CONCLUSIONS	The study will be one of the first randomised controlled trials to test the effectiveness of clinical networks to lead changes in clinical practice in hospitals treating patients with high-risk cancer .
CONCLUSIONS	It will additionally provide direction regarding implementation strategies that can be effectively employed to encourage widespread adoption of clinical practice guidelines .
BACKGROUND	Australian New Zealand Clinical Trials Registry ( ANZCTR ) : ACTRN12611001251910 .

###25229836
OBJECTIVE	To compare whole-body vibration ( WBV ) with traditional recovery protocols after a high-intensity training bout .
METHODS	In a randomized crossover study , 16 athletes performed 6 30-s Wingate sprints before completing either an active recovery ( 10 min of cycling and stretching ) or WBV for 10 min in a series of exercises on a vibration platform .
METHODS	Muscle hemodynamics ( assessed via near-infrared spectroscopy ) were measured before and during exercise and into the 10-min recovery period .
METHODS	Blood lactate concentration , vertical jump , quadriceps strength , flexibility , rating of perceived exertion ( RPE ) , muscle soreness , and performance during a single 30-s Wingate test were assessed at baseline and 30 and 60 min postexercise .
METHODS	A subset of participants ( n = 6 ) completed a 3rd identical trial ( 1 wk later ) using a passive 10-min recovery period ( sitting ) .
RESULTS	There were no clear effects between the recovery protocols for blood lactate concentration , quadriceps strength , jump height , flexibility , RPE , muscle soreness , or single Wingate performance across all measured recovery time points .
RESULTS	However , the WBV recovery protocol substantially increased the tissue-oxygenation index compared with the active ( 11.2 % 2.4 % [ mean 95 % CI ] , effect size [ ES ] = 3.1 , and -7.3 % 4.1 % , ES = -2.1 for the 10 min postexercise and postrecovery , respectively ) and passive recovery conditions ( 4.1 % 2.2 % , ES = 1.3 , 10 min postexercise only ) .
CONCLUSIONS	Although WBV during recovery increased muscle oxygenation , it had little effect in improving subsequent performance compared with a normal active recovery .

###24954344
OBJECTIVE	Epidural analgesia has been the preferred analgesic technique after major abdominal surgery .
OBJECTIVE	On the other hand , the combined use of intrathecal morphine ( ITM ) and intravenous patient controlled analgesia ( IVPCA ) has been shown to be a viable alternative approach for analgesia .
OBJECTIVE	We hypothesized that ITM combined with IVPCA is as effective as patient controlled thoracic epidural analgesia ( PCTEA ) with respect to postoperative pain control after conventional open gastrectomy .
METHODS	Sixty-four patients undergoing conventional open gastrectomy due to gastric cancer were randomly allocated into the intrathecal morphine combined with intravenous patient-controlled analgesia ( IT ) group or patient-controlled thoracic epidural analgesia ( EP ) group .
METHODS	The IT group received preoperative 0.3 mg of ITM , followed by postoperative IVPCA .
METHODS	The EP group preoperatively underwent epidural catheterization , followed by postoperative PCTEA .
METHODS	Visual analog scale ( VAS ) scores were assessed until 48 hrs after surgery .
METHODS	Adverse effects related to analgesia , profiles associated with recovery from surgery , and postoperative complications within 30 days after surgery were also evaluated .
RESULTS	This study failed to demonstrate the non-inferiority of ITM-IVPCA ( n = 29 ) to PCTEA ( n = 30 ) with respect to VAS 24 hrs after surgery .
RESULTS	Furthermore , the IT group consumed more fentanyl than the EP group did ( 1247.2263.7 g vs. 1048.971.7 g , p < 0.001 ) .
RESULTS	The IT group took a longer time to ambulate than the EP group ( p = 0.021 ) and had higher incidences of postoperative ileus ( p = 0.012 ) and pulmonary complications ( p = 0.05 ) compared with the EP group .
CONCLUSIONS	ITM-IVPCA is not as effective as PCTEA in patients undergoing gastrectomy , with respect to pain control , ambulation , postoperative ileus and pulmonary complications .

###24510496
OBJECTIVE	To assess the safety and tolerability of high-dose creatine , the feasibility of enrolling premanifest and 50 % at-risk subjects in a prevention trial , and the potential of cognitive , imaging , and blood markers .
METHODS	Sixty-four eligible consenting participants were randomly allocated ( 1:1 ) to 15 g twice daily of creatine monohydrate or placebo for a 6-month double-blind phase followed by a 12-month open-label extension .
METHODS	Subjects included premanifest ( tested ) and at-risk ( not tested ) individuals without clinical symptoms or signs of Huntington disease ( HD ) .
METHODS	Primary outcomes were safety and tolerability .
METHODS	Exploratory endpoints included fine motor , visuospatial , and memory performance ; structural and diffusion MRI ; and selected blood markers .
RESULTS	Forty-seven HD carriers and 17 non-HD controls were enrolled .
RESULTS	Fifteen discontinued treatment ( 2 assigned to placebo ) ; all were followed for the entire study period .
RESULTS	Primary analysis was by intent to treat .
RESULTS	The most common adverse events were gastrointestinal .
RESULTS	Neuroimaging demonstrated treatment-related slowing of cortical and striatal atrophy at 6 and 18 months .
CONCLUSIONS	We describe a design that preserves the autonomy of subjects not wanting genetic testing while including controls for assessing the specificity of treatment effects .
CONCLUSIONS	Our results demonstrate the feasibility of prevention trials for HD and the safety of high-dose creatine , provide possible evidence of disease modification , support future studies of creatine , and illustrate the value of prodromal biomarkers .
METHODS	This study provides Class I evidence that high-dose creatine is safe and tolerable .

###24568566
OBJECTIVE	This study examined the impact on college students ' perceptions of nonmedical use of prescription stimulants ( NMUPS ) of motivation for use and gender .
METHODS	Participants were college students ( N = 695 ) from 2 universities in different regions of the United States .
METHODS	Participants read a vignette describing a college student who used a prescription stimulant for a nonmedical purpose and rated their perception of that individual using a semantic differential .
METHODS	A 2 ( participant gender ) by 2 ( gender of the individual described in the vignette ) by 3 ( motive for use : get high , study , lose weight ) design was used .
RESULTS	The male who used a stimulant to study was rated significantly less negatively than if he used the stimulant to get high .
RESULTS	NMUPS as a study aid was viewed the least negatively overall .
CONCLUSIONS	Findings suggest that gender does not , whereas motivation for use does , impact students ' perceptions of NMUPS .

###24983746
OBJECTIVE	Semagacestat , a - secretase inhibitor , demonstrated an unfavorable risk-benefit profile in a Phase 3 study of patients with Alzheimer 's disease ( IDENTITY trials ) , and clinical development was halted .
OBJECTIVE	To assist in future development of - secretase inhibitors , we report detailed safety findings from the IDENTITY study , with emphasis on those that might be mechanistically linked to - secretase inhibition .
METHODS	The IDENTITY trial was a double-blind , placebo-controlled trial of semagacestat ( 100mg and 140mg ) , in which 1537 patients age 55 years and older with probable Alzheimer 's disease were randomized .
METHODS	Treatment-emergent adverse events ( TEAEs ) are reported by body system along with pertinent laboratory , vital sign , and ECG findings .
RESULTS	Semagacestat treatment was associated with increased reporting of suspected Notch-related adverse events ( gastrointestinal , infection , and skin cancer related ) .
RESULTS	Other relevant safety findings associated with semagacestat treatment included cognitive and functional worsening , skin-related TEAEs , renal and hepatic changes , increased QT interval , and weight loss .
RESULTS	With few exceptions , differences between semagacestat and placebo treatment groups were no longer significant after cessation of treatment with active drug .
CONCLUSIONS	Many of these safety findings can be attributed to - secretase inhibition , and may be valuable to researchers developing - secretase inhibitors .

###25266206
BACKGROUND	The purpose of this study was to determine whether a high-protein afternoon yogurt snack improves appetite control , satiety , and reduces subsequent food intake compared to other commonly-consumed , energy dense , high-fat snacks .
RESULTS	Twenty , healthy women ( age : 272 y ; BMI : 23.40.7 kg/m2 ) completed the randomized crossover design study which included 3 , 8-h testing days comparing the following 160 kcal afternoon snacks : high-protein yogurt ( 14 g protein/25 g CHO/0 g fat ) ; high-fat crackers ( 0 g protein/19 g CHO/9 g fat ) ; and high-fat chocolate ( 2 g protein/19 g CHO/9 g fat ) .
RESULTS	Participants were acclimated to each snack for 3 consecutive days .
RESULTS	On day 4 , the participants consumed a standardized breakfast and lunch ; the respective snack was consumed 3-h post-lunch .
RESULTS	Perceived hunger and fullness were assessed throughout the afternoon until dinner was voluntarily requested .
RESULTS	An ad libitum dinner was then provided .
RESULTS	The consumption of the yogurt snack led to greater reductions in afternoon hunger vs. chocolate ( p < 0.01 ) .
RESULTS	No differences in afternoon fullness were detected .
RESULTS	The yogurt snack also delayed eating initiation by approximately 30 min compared to the chocolate snack ( p < 0.01 ) and approximately 20 min vs. crackers ( p = 0.07 ) .
RESULTS	The yogurt snack led to approximately 100 fewer kcals consumed at dinner vs. the crackers ( p = 0.08 ) and chocolate ( p < 0.05 ) .
RESULTS	No other differences were detected .
CONCLUSIONS	These data suggest that , when compared to high-fat snacks , eating less energy dense , high-protein snacks like yogurt improves appetite control , satiety , and reduces subsequent food intake in healthy women .

###25176085
OBJECTIVE	To study the effects of dopamine and phenylephrine for treatment of hypotension during cesarean section under combined spinal epidural anesthesia ( CSEA ) on the stereology of the placenta .
METHODS	Forty puerperants undergoing cesarean section under CSEA were randomly divided into dopamine group and phenylephrine group .
METHODS	Ropivacaine ( 16 mg ) was administered immediately after spinal anethesia .
METHODS	Blood pressure was maintained near the baseline by adjusting the drug infusion rate .
METHODS	Fetal blood gas , Apgar score , and placental villus microvascular stereological changes were observed during the operation .
RESULTS	The microvascular density was significantly lower in dopamine group than in phenylephrine group ( P < 0.05 ) .
RESULTS	Phenylephrine group showed significantly lower umbilical artery blood pH than dopamine group ( P < 0.05 ) .
RESULTS	The Apgar score and blood pressure were comparable between the two groups ( P > 0.05 ) .
RESULTS	Compared to the baseline , both of the two groups showed significantly lowered heart rate during the operation ( P < 0.01 ) .
CONCLUSIONS	Dopamine is associated with the risk of fetal acidosis .
CONCLUSIONS	Phenylephrine is helpful for preventing hypotension by increasing placental blood flow and improving oxygen supply to ensure maternal and fetal safety during cesarean section .

###25125457
BACKGROUND	In patients with Alzheimer 's disease ( AD ) , the relationship between cognitive and functional progression is not fully understood ; however , functional decline has been postulated to follow cognitive decline .
OBJECTIVE	To assess the relationship between cognitive and functional treatment effects in mild AD dementia patients .
METHODS	Data of patients with mild AD were pooled from two multicenter , double-blind , Phase 3 studies .
METHODS	Patients were randomized to infusions of 400-mg solanezumab ( n = 654 ) , or placebo ( n = 660 ) every 4 weeks for 18 months .
METHODS	Cognitive and functional outcome measures were assessed using the AD Assessment Scale-Cognitive subscale ( ADAS-Cog ) and the AD Cooperative Study-Activities of Daily Living ( ADCS-ADL ) , respectively .
METHODS	Analyses included comparisons among normalized scales , correlations between outcome measures , and path analyses to model the relationship of treatment effect on cognition and function .
RESULTS	Normalized ADAS-Cog and ADCS-ADL scales showed cognitive impairment was more evident than functional impairment in mild AD .
RESULTS	The correlation between cognition and function increased over time .
RESULTS	Path analyses demonstrated that 87 % of the treatment effect on function was driven by the treatment effect on cognition , with the remaining 13 % due to direct treatment effect .
CONCLUSIONS	Findings from this study are consistent with the hypothesis that functional impairment is primarily driven by and follows cognitive decline in mild AD dementia .
CONCLUSIONS	The cognitive treatment effect appeared to explain the majority of the functional treatment effect .
CONCLUSIONS	It is possible that a cognitive treatment effect may be considered as a leading indicator for functional outcomes in an 18-month clinical trial for milder stages of AD .

###24746549
OBJECTIVE	To determine whether response to a dietary intervention is greater among people with family history of colorectal cancer ( CRC ) compared with a general population .
METHODS	Cohort study examining participants from 2 related studies .
METHODS	Rural Virginia .
METHODS	Seventy people with first-degree relatives with CRC and 113 participants from the intervention arm of a trial in the general population .
METHODS	Both studies implemented a low-intensity intervention delivered via telephone and mail , including low-literacy self-help booklets and personalized dietary feedback .
METHODS	Fat , fiber , and fruit and vegetable behavior .
METHODS	Propensity score matching controlled for confounders .
METHODS	Mixed-model ANOVAs compared samples ; mediation by perceived cancer risk was assessed .
RESULTS	Participants in both groups significantly improved fat , fiber , and fruit and vegetable behavior at 1-month follow-up ; there was significantly greater improvement in the general population sample .
RESULTS	Cancer risk perception did not mediate the relationship between study sample and dietary change .
CONCLUSIONS	Contrary to expectations , first-degree relatives of CRC patients did not respond better to a dietary intervention than the general population , nor was risk perception related to dietary change .
CONCLUSIONS	Given the role of diet in CRC risk , additional research should investigate targeted strategies to improve dietary intakes of people at higher cancer risk .

###26086941
OBJECTIVE	To compare changes in vitamin D status and cathelicidin ( LL-37 ) levels in septic ICU patients treated with placebo versus cholecalciferol .
METHODS	Randomized , placebo-controlled , trial .
METHODS	Medical and surgical ICUs of a single teaching hospital in Boston , MA .
METHODS	Thirty adult ICU patients .
METHODS	Placebo ( n = 10 ) versus 200,000 IU cholecalciferol ( n = 10 ) versus 400,000 IU cholecalciferol ( n = 10 ) , within 24 hours of new-onset severe sepsis or septic shock .
RESULTS	Blood samples were obtained at baseline ( day 1 ) and on days 3 , 5 , and 7 , to assess total 25-hydroxyvitamin D , as well as vitamin D-binding protein and albumin to calculate bioavailable 25-hydroxyvitamin D. Plasma LL-37 and high-sensitivity C-reactive protein levels were also measured .
RESULTS	At baseline , median ( interquartile range ) plasma 25-hydroxyvitamin D was 17ng/mL ( 13-22ng / mL ) and peaked by day 5 in both intervention groups .
RESULTS	Groups were compared using Kruskal-Wallis tests .
RESULTS	Relative to baseline , on day 5 , median change in biomarkers for placebo , 200,000 IU cholecalciferol , and 400,000 IU cholecalciferol groups , respectively , were as follows : 1 ) total 25-hydroxyvitamin D , 3 % ( -3 % to 8 % ) , 49 % ( 30-82 % ) , and 69 % ( 55-106 % ) ( p < 0.001 ) ; 2 ) bioavailable 25-hydroxyvitamin D , 4 % ( -8 % to 7 % ) , 45 % ( 40-70 % ) , and 96 % ( 58-136 % ) ( p < 0.01 ) ; and 3 ) LL-37 : -17 % ( -9 % to -23 % ) , 4 % ( -10 % to 14 % ) , and 30 % ( 23-48 % ) ( p = 0.04 ) .
RESULTS	Change in high-sensitivity C-reactive protein levels did not differ between groups .
RESULTS	A positive correlation was observed between bioavailable 25-hydroxyvitamin D and LL-37 ( Spearman = 0.44 ; p = 0.03 ) but not for total 25-hydroxyvitamin D and LL-37 .
CONCLUSIONS	High-dose cholecalciferol supplementation rapidly and safely improves 25-hydroxyvitamin D and bioavailable 25-hydroxyvitamin D levels in patients with severe sepsis or septic shock .
CONCLUSIONS	Changes in bioavailable 25-hydroxyvitamin D are associated with concomitant increases in circulating LL-37 levels .
CONCLUSIONS	Larger trials are needed to verify these findings and to assess whether optimizing vitamin D status improves sepsis-related clinical outcomes .

###24561009
BACKGROUND	Conflicting data exist regarding the association between left ventricular ( LV ) lead position and benefit from cardiac resynchronization therapy .
BACKGROUND	We evaluated the relationships between LV lead positions and the risk of death or hospitalization for heart failure ( HF ) in the cardiac resynchronization therapy arm of the Resynchronization-Defibrillation for Ambulatory Heart Failure Trial ( RAFT ) .
METHODS	LV lead position was categorized by site investigator ( MD ) and in a chest radiograph core laboratory ( CXR ) as `` anterior , '' `` lateral , '' or `` posterior '' in the short axis , and `` basal , '' `` mid , '' or `` apical '' in the long axis .
METHODS	Agreement between MD and CXR LV lead position classification was evaluated and the independent relationship between LV lead position and clinical outcome was assessed using Cox multivariable models .
RESULTS	Agreement between MD and CXR LV lead position was poor ( 0.26 ) .
RESULTS	Over 39 20 months , 140 of 447 ( 31.3 % ) patients met the RAFT primary end point ( death or HF hospitalization ) .
RESULTS	In adjusted analyses , neither MD-determined nor CXR-determined anterior or apical LV lead position was significantly associated with the primary outcome .
RESULTS	However , CXR-defined apical LV lead position was associated with a higher risk of HF hospitalization ( hazard ratio , 1.99 ; P = 0.004 ) .
CONCLUSIONS	Poor agreement between implanting physician and core lab CXR-based categorizations of LV lead position was observed .
CONCLUSIONS	Neither categorization method resulted in significant associations between apical or anterior LV lead position and the risk of the composite primary outcome of death or heart failure hospitalization .
CONCLUSIONS	However , CXR-defined apical lead position was associated with increased risk of HF hospitalization .

###24323402
OBJECTIVE	This article presents the results of a multiuser , randomized laboratory trial comparing the accuracy and precision of image-based navigation against individualized guides for distal radius osteotomy ( DRO ) .
METHODS	Six surgeons each performed four DROs using image-based navigation and four DROs using individualized guides in a laboratory setting with plastic phantom replicas of radii from patients who had received DRO as treatment for radial deformity .
METHODS	Time required and correction errors of ulnar variance , radial inclination , and volar tilt were measured .
RESULTS	There were no statistically significant differences in the average correction errors .
RESULTS	There was a statistically significant difference in the standard deviation of ulnar variance error ( 2.0 mm for navigation vs. 0.6 mm for guides ) .
RESULTS	There was a statistically significant difference in the standard deviation of radial inclination error ( [ Formula : see text ] for navigation vs. [ Formula : see text ] for guides ) .
RESULTS	There were statistically significant differences in the times required ( 705 s for navigation vs. 214 s for guides ) and their standard deviations ( 144 s for navigation vs. 98 s for guides ) .
CONCLUSIONS	Compared to navigated DRO , individualized guides were easier to use , faster , and produced more precise correction of ulnar variance and radial inclination .
CONCLUSIONS	The combination of true three-dimensional planning , ease of use , and accurate and precise corrective guidance makes the individualized guide technique a promising approach for performing corrective osteotomy of the distal radius .

###25676904
OBJECTIVE	To assess the efficacy and short-term safety of levodopa as adjunctive treatment to patching for amblyopia .
METHODS	Randomized , placebo-controlled trial .
METHODS	One hundred thirty-nine children 7 to 12 years of age with residual amblyopia resulting from strabismus , anisometropia , or both combined ( visual acuity [ VA ] , 20/50-20 / 400 ) after patching .
METHODS	Sixteen weeks of oral levodopa or placebo administered 3 times daily while patching the fellow eye 2 hours daily .
METHODS	Mean change in best-corrected amblyopic-eye VA at 18 weeks .
RESULTS	At 18 weeks , amblyopic-eye VA improved from randomization by an average of 5.2 letters in the levodopa group and by 3.8 letters in the placebo group ( difference adjusted for baseline VA , +1.4 letters ; 1-sided P = 0.06 ; 2-sided 95 % confidence interval , -0.4 to 3.3 letters ) .
RESULTS	No serious adverse effects from levodopa were reported during treatment .
CONCLUSIONS	For children 7 to 12 years of age with residual amblyopia after patching therapy , oral levodopa while continuing to patch 2 hours daily does not produce a clinically or statistically meaningful improvement in VA compared with placebo and patching .

###24461574
BACKGROUND	Teriflunomide is an oral disease-modifying therapy approved for treatment of relapsing or relapsing-remitting multiple sclerosis .
BACKGROUND	We aimed to provide further evidence for the safety and efficacy of teriflunomide in patients with relapsing multiple sclerosis .
METHODS	This international , randomised , double-blind , placebo-controlled , phase 3 study enrolled adults aged 18-55 years with relapsing multiple sclerosis , one or more relapse in the previous 12 months or two or more in the previous 24 months but no relapse in the previous 30 days , and an Expanded Disability Status Scale ( EDSS ) score of 5.5 points or less .
METHODS	Patients were recruited from 189 sites in 26 countries and randomly assigned ( 1:1:1 ) to once-daily placebo , teriflunomide 7 mg , or teriflunomide 14 mg via an interactive voice recognition system .
METHODS	Treatment duration was variable , ending 48 weeks after the last patient was included .
METHODS	The primary endpoint was annualised relapse rate ( number of relapses per patient-year ) and the key secondary endpoint was time to sustained accumulation of disability ( an EDSS score increase of at least 1 EDSS point sustained for a minimum of 12 weeks ) , both analysed in the modified intention-to-treat population ( all patients who received at least one dose of assigned study medication ) .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00751881 .
RESULTS	Between Sept 17 , 2008 , and Feb 17 , 2011 , 1169 patients were randomly assigned to a treatment group , of whom 388 , 407 , and 370 patients received at least one dose of placebo , teriflunomide 7 mg , or teriflunomide 14 mg , respectively .
RESULTS	By the end of the study , the annualised relapse rate was higher in patients assigned to placebo ( 0.50 [ 95 % CI 0.43-0 .58 ] ) than in those assigned to teriflunomide 14 mg ( 0.32 [ 0.27-0 .38 ] ; p = 0.0001 ) or teriflunomide 7 mg ( 0.39 [ 0.33-0 .46 ] ; p = 0.0183 ) .
RESULTS	Compared with placebo , teriflunomide 14 mg reduced the risk of sustained accumulation of disability ( hazard ratio [ HR ] 0.68 [ 95 % CI 0.47-1 .00 ] ; log-rank p = 0.0442 ) ; however , teriflunomide 7 mg had no effect on sustained accumulation of disability ( HR 0.95 [ 0.68-1 .35 ] ; log-rank p = 0.7620 ) .
RESULTS	The most common adverse events were alanine aminotransferase increases ( 32 [ 8 % ] of 385 patients in the placebo group vs 46 [ 11 % ] of 409 patients in the teriflunomide 7 mg group vs 52 [ 14 % ] of 371 patients in the teriflunomide 14 mg group ) , hair thinning ( 17 [ 4 % ] vs 42 [ 10 % ] vs 50 [ 13 % ] ) , and headache ( 42 [ 11 % ] vs 60 [ 15 % ] vs 46 [ 12 % ] ) .
RESULTS	Incidence of serious adverse events was similar in all treatment groups ( 47 [ 12 % ] vs 52 [ 13 % ] vs 44 [ 12 % ] ) .
RESULTS	Four deaths occurred , none of which was considered to be related to study drug ( respiratory infection in the placebo group , traffic accident in the teriflunomide 7 mg group , and suicide and septicaemia due to Gram-negative infection complicated by disseminated intravascular coagulopathy in the teriflunomide 14 mg group ) .
CONCLUSIONS	Teriflunomide 14 mg was associated with a lower relapse rate and less disability accumulation compared with placebo , with a similar safety and tolerability profile to that reported in previous studies .
CONCLUSIONS	These results confirm the dose effect reported in previous trials and support the use of teriflunomide 14 mg in patients with relapsing multiple sclerosis .
BACKGROUND	Genzyme , a Sanofi company .

###24996498
OBJECTIVE	To determine whether hysterosalpingo-foam sonography ( HyFoSy ) is a less painful first line tubal patency test than serial hysterosalpingography ( HSG ) .
METHODS	A two-center , prospective , open-label , randomized , controlled trial .
METHODS	University hospital and teaching hospital .
METHODS	40 subfertile women , ages 18 to 41years , with an indication for tubal patency testing as part of the fertility workup according to the Dutch Nederlandse Vereniging voor Obsteterie & Gynaecologie-guidelines .
METHODS	Tubal patency testing by HyFoSy versus serial HSG .
METHODS	Visual Analogue Scale ( VAS ) pain scores during tubal patency testing .
RESULTS	The median VAS score for pain perception during the HyFoSy procedure was 1.7 cm ( interquartile range : 2.1 ) compared with 3.7 cm ( interquartile range : 4.2 ) during HSG .
RESULTS	The HyFoSy procedure also had a statistically significantly shorter procedure time compared with HSG , with a median of 5.0 minutes ( interquartile range : 3.0 ) for HyFoSy versus 12.5 minutes ( interquartile range : 16.0 ) for HSG .
CONCLUSIONS	The HyFoSy procedure is a less painful and less time-consuming tubal patency test compared with HSG .
BACKGROUND	Netherlands National Trial Register NTR3457 .

###24740528
OBJECTIVE	Few pharmacotherapies have demonstrated sufficient efficacy in the treatment of posttraumatic stress disorder ( PTSD ) , a chronic and disabling condition .
OBJECTIVE	To test the efficacy and safety of a single intravenous subanesthetic dose of ketamine for the treatment of PTSD and associated depressive symptoms in patients with chronic PTSD .
METHODS	Proof-of-concept , randomized , double-blind , crossover trial comparing ketamine with an active placebo control , midazolam , conducted at a single site ( Icahn School of Medicine at Mount Sinai , New York , New York ) .
METHODS	Forty-one patients with chronic PTSD related to a range of trauma exposures were recruited via advertisements .
METHODS	Intravenous infusion of ketamine hydrochloride ( 0.5 mg/kg ) and midazolam ( 0.045 mg/kg ) .
METHODS	The primary outcome measure was change in PTSD symptom severity , measured using the Impact of Event Scale-Revised .
METHODS	Secondary outcome measures included the Montgomery-Asberg Depression Rating Scale , the Clinical Global Impression-Severity and - Improvement scales , and adverse effect measures , including the Clinician-Administered Dissociative States Scale , the Brief Psychiatric Rating Scale , and the Young Mania Rating Scale .
RESULTS	Ketamine infusion was associated with significant and rapid reduction in PTSD symptom severity , compared with midazolam , when assessed 24 hours after infusion ( mean difference in Impact of Event Scale-Revised score , 12.7 [ 95 % CI , 2.5-22 .8 ] ; P = .02 ) .
RESULTS	Greater reduction of PTSD symptoms following treatment with ketamine was evident in both crossover and first-period analyses , and remained significant after adjusting for baseline and 24-hour depressive symptom severity .
RESULTS	Ketamine was also associated with reduction in comorbid depressive symptoms and with improvement in overall clinical presentation .
RESULTS	Ketamine was generally well tolerated without clinically significant persistent dissociative symptoms .
CONCLUSIONS	This study provides the first evidence for rapid reduction in symptom severity following ketamine infusion in patients with chronic PTSD .
CONCLUSIONS	If replicated , these findings may lead to novel approaches to the pharmacologic treatment of patients with this disabling condition .
BACKGROUND	clinicaltrials.gov Identifier : NCT00749203 .

###25044535
OBJECTIVE	There is limited information about the effects of beta-blockers in heart failure ( HF ) stratified by blood pressure , especially in the elderly and those with preserved EF .
OBJECTIVE	We evaluate the effects of nebivolol on outcomes in elderly patients with HF stratified by baseline systolic blood pressure ( SBP ) and EF .
RESULTS	The SENIORS trial evaluated the effects of nebivolol and enrolled 2128 patients 70 years of age with HF .
RESULTS	Patients were divided into three baseline pre-treatment SBP categories ( < 110 , 110-130 , and > 130 mmHg ) .
RESULTS	In addition , we evaluated the influence of SBP ( 130 and > 130 mmHg ) on patients with LVEF < 40 % vs. 40 % .
RESULTS	Low baseline SBP was associated with worse clinical outcomes irrespective of treatment group , both in patients with reduced EF and in those with preserved EF .
RESULTS	Nebivolol had similar benefits irrespective of baseline SBP : the hazard ratio ( HR ) for primary outcome of all-cause mortality or cardiovascular hospitalization in the three SBP categories for nebivolol vs. placebo was 0.85 [ 95 % confidence interval ( CI ) 0.50-1 .45 ] , 0.79 ( 95 % CI 0.61-1 .01 ) , and 0.88 ( 95 % CI 0.72-1 .07 ) , respectively ( P for interaction = 0.61 ) .
RESULTS	Similar results were obtained for the secondary endpoint of all-cause mortality .
RESULTS	There was no significant interaction for the effects of nebivolol by baseline SBP stratified by LVEF .
CONCLUSIONS	Elderly HF patients with lower SBP have a worse outcome than those with higher SBP , but nebivolol appears to be safe and well tolerated , with similar benefits on the composite outcome of death or cardiovascular hospital admission irrespective of baseline SBP and LVEF .

###24727022
OBJECTIVE	MK-5172 is an inhibitor of the hepatitis C virus ( HCV ) nonstructural protein 3/4A protease ; MK-5172 is taken once daily and has a higher potency and barrier to resistance than licensed protease inhibitors .
OBJECTIVE	We investigated the efficacy and tolerability of MK-5172 with peginterferon and ribavirin ( PR ) in treatment-naive patients with chronic HCV genotype 1 infection without cirrhosis .
METHODS	We performed a multicenter , double-blind , randomized , active-controlled , dose-ranging , response-guided therapy study .
METHODS	A total of 332 patients received MK-5172 ( 100 , 200 , 400 , or 800 mg ) once daily for 12 weeks in combination with PR .
METHODS	Patients in the MK-5172 groups received PR for an additional 12 or 36 weeks , based on response at week 4 .
METHODS	Patients in the control group ( n = 66 ) received a combination of boceprevir and PR , dosed in accordance with boceprevir 's US product circular .
RESULTS	At 24 weeks after the end of therapy , sustained virologic responses were achieved in 89 % , 93 % , 91 % , and 86 % of the patients in the groups given the combination of PR and MK-5172 ( 100 , 200 , 400 , or 800 mg ) , respectively , vs 61 % of controls .
RESULTS	In the MK-5172 group receiving 100 mg , 91 % of patients had undetectable levels of HCV RNA at week 4 and qualified for the short duration of therapy .
RESULTS	The combination of MK-5172 and PR generally was well tolerated .
RESULTS	Transient increases in transaminase levels were noted in the MK-5172 groups given 400 and 800 mg , at higher frequencies than in the MK-5172 groups given 100 or 200 mg , or control groups .
CONCLUSIONS	Once-daily MK-5172 ( 100 mg ) with PR for 24 or 48 weeks was highly effective and well tolerated among treatment-naive patients with HCV genotype 1 infection without cirrhosis .
CONCLUSIONS	Studies are underway to evaluate interferon-free MK-5172-based regimens .
CONCLUSIONS	ClinicalTrials.gov number : NCT01353911 .

###24584988
OBJECTIVE	This 24-month study , conducted in The Netherlands , examined the feasibility of enhancing the effectiveness of assertive community treatment ( ACT ) by adding evidence-based interventions .
METHODS	A total of 159 patients were randomly assigned to two ACT teams , one providing standard ACT ( N585 ) and an ACT Plus team that also provided evidence-based interventions ( N574 ) : psychoeducation , family interventions , individual placement and support , and cognitive behavioral therapy .
METHODS	The interventions were conducted by psychologists and nurse practitioners working independently from the ACT team .
RESULTS	Although most patients were judged eligible for each of the four interventions ( range 65 % to 89 % ) , only 12 of the 74 patients ( 16 % ) successfully completed an intervention .
RESULTS	Outcomes , such as use of inpatient care , for ACT Plus and standard ACT patients did not differ significantly .
CONCLUSIONS	Guidelines for the treatment of schizophrenia should consider the feasibility of delivering evidence-based interventions to difficult-to-engage patients .

###25545025
BACKGROUND	Despite an increase in overweight and obesity similar to the civilian population , there have been few randomized controlled trials examining behavioral weight management interventions in the military settings .
OBJECTIVE	This paper describes the design , intervention development and analysis plan of the Fit Blue study , a randomized controlled behavioral weight loss trial taking place in the United States Air Force .
METHODS	This study compares two adapted versions of the efficacious Look AHEAD Intensive Lifestyle Intervention ( ILI ) , a counselor-initiated condition and a self-paced condition .
METHODS	Also described are the unique steps required when conducting military-based health promotion research and adaptations made to the Look AHEAD intervention to accommodate the military environment .
CONCLUSIONS	To our knowledge , this is the first translation of the Look AHEAD ILI in the military setting and one of the first translations of the ILI in general .
CONCLUSIONS	If successful , this intervention could be disseminated to the entire U.S. Military as this project is designed to overcome the barriers and utilize the facilitators for weight loss that are unique to a military population .
CONCLUSIONS	Programs validated in military populations can have a major public health impact given that with 1.4 million active duty personnel , the Department of Defense is the nation 's largest employer .
CONCLUSIONS	However , while this intervention is designed for a military population and there are unique aspects of the military that may enhance weight loss interventions , the diversity of the study population should help inform obesity efforts in both civilian and military settings .

###26107752
OBJECTIVE	Long-acting , injectable , second-generation antipsychotic medication has tremendous potential to bring clinical stability to persons with schizophrenia .
OBJECTIVE	However , long-acting medications are rarely used following a first episode of schizophrenia .
OBJECTIVE	To compare the clinical efficacy of the long-acting injectable formulation of risperidone with the oral formulation in the early course of schizophrenia .
METHODS	A randomized clinical trial performed at a university-based research clinic , between 2005 and 2012 .
METHODS	Eighty-six patients with recent onset of schizophrenia were randomized to receive long-acting injectable risperidone or oral risperidone .
METHODS	Half of each group was simultaneously randomized to receive cognitive remediation to improve cognitive functioning or healthy-behaviors training to improve lifestyle habits and well-being .
METHODS	An intent-to-treat analysis was performed between October 4 , 2012 , and November 12 , 2014 .
METHODS	A 12-month trial comparing the long-acting injectable vs oral risperidone and cognitive remediation vs healthy-behaviors training .
METHODS	Psychotic relapse and control of breakthrough psychotic symptoms .
RESULTS	Of the 86 patients randomized , 3 refused treatment in the long-acting injectable risperidone group .
RESULTS	The psychotic exacerbation and/or relapse rate was lower for the long-acting risperidone group compared with the oral group ( 5 % vs 33 % ; 21 = 11.1 ; P < .001 ; relative risk reduction ,84.7 % ) .
RESULTS	Long-acting injectable risperidone better controlled mean levels of hallucinations and delusions throughout follow-up ( = -0.30 ; t68 = -2.6 , P = .01 ) .
RESULTS	The cognitive remediation and healthy-behaviors training groups did not differ significantly regarding psychotic relapse , psychotic symptom control , or hospitalization rates , and there were no significant interactions between the 2 medications and the 2 psychosocial treatments .
RESULTS	Discontinuations owing to inadequate clinical response were more common in the oral group than in the long-acting risperidone group ( 21 = 6.1 ; P = .01 ) .
RESULTS	Adherence to oral risperidone did not appear to differ before randomization but was better for the long-acting risperidone group compared with the oral group ( t80 = 5.3 ; P < .001 ) .
RESULTS	Medication adherence was associated with prevention of exacerbation and/or relapse ( 21 = 11.1 ; P = .003 ) and control of breakthrough psychotic symptoms ( = 0.2 ; t79 = 2.1 ; P = .04 ) .
CONCLUSIONS	The use of long-acting injectable risperidone after a first episode of schizophrenia has notable advantages for clinical outcomes .
CONCLUSIONS	The key clinical advantages are apparently owing to the more consistent administration of the long-acting injectable .
CONCLUSIONS	Such formulations should be offered earlier in the course of illness .
BACKGROUND	clinicaltrials.gov Identifier : NCT00333177 .

###24504006
BACKGROUND	Studies in HIV-1-infected infants and HIV-1-exposed , uninfected infants link early cytomegalovirus ( CMV ) acquisition with growth delay and cognitive impairment .
BACKGROUND	We investigated maternal valacyclovir to delay infant acquisition of CMV .
METHODS	Pregnant women with HIV-1 , HSV-2 and CD4 count > 250 cells/l were randomized at 34 weeks gestation to 500 mg twice-daily valacyclovir or placebo for 12 months .
METHODS	Maternal CMV DNA was measured in plasma at 34 weeks gestation , in cervical secretions at 34 and 38 weeks gestation , and in breast milk at 7 postpartum timepoints ; infant CMV DNA was measured in dried blood spots at 8 timepoints including birth .
RESULTS	Among 148 women , 141 infants were compared in intent-to-treat analyses .
RESULTS	Maternal and infant characteristics were similar between study arms .
RESULTS	Infant CMV acquisition did not differ between study arms , with 46/70 infants ( 66 % ) in placebo arm and 47/71 infants ( 66 % ) in the valacyclovir arm acquiring CMV ; median time to CMV detection did not differ .
RESULTS	CMV DNA was detected in 92 % of 542 breast milk specimens with no difference in CMV level between study arms .
RESULTS	Change in cervical shedding of CMV DNA between baseline and 38 weeks was 0.40-log greater in the placebo arm than the valacyclovir arm ( p = 0.05 ) .
CONCLUSIONS	In this cohort of HIV-1-seropositive mothers , two-thirds of infants acquired CMV by one year .
CONCLUSIONS	Maternal valacyclovir had no effect on timing of infant CMV acquisition or breast milk CMV viral loads , although it modestly reduced cervical CMV shedding .
CONCLUSIONS	Maternal prophylaxis to reduce infant CMV acquisition warrants further evaluation in trials with antiviral agents .
BACKGROUND	ClinicalTrials.gov NCT00530777 .

###25348614
BACKGROUND	The Southeastern United States has the lowest kidney transplant rates in the nation , and racial disparities in kidney transplant access are concentrated in this region .
BACKGROUND	The Southeastern Kidney Transplant Coalition ( SEKTC ) of Georgia , North Carolina , and South Carolina is an academic and community partnership that was formed with the mission to improve access to kidney transplantation and reduce disparities among African American ( AA ) end stage renal disease ( ESRD ) patients in the Southeastern United States .
METHODS	We describe the community-based participatory research ( CBPR ) process utilized in planning the Reducing Disparities In Access to kidNey Transplantation ( RaDIANT ) Community Study , a trial developed by the SEKTC to reduce health disparities in access to kidney transplantation among AA ESRD patients in Georgia , the state with the lowest kidney transplant rates in the nation .
METHODS	The SEKTC Coalition conducted a needs assessment of the ESRD population in the Southeast and used results to develop a multicomponent , dialysis facility-randomized , quality improvement intervention to improve transplant access among dialysis facilities in GA. .
METHODS	A total of 134 dialysis facilities are randomized to receive either : ( 1 ) standard of care or `` usual '' transplant education , or ( 2 ) the multicomponent intervention consisting of transplant education and engagement activities targeting dialysis facility leadership , staff , and patients within dialysis facilities .
METHODS	The primary outcome is change in facility-level referral for kidney transplantation from baseline to 12months ; the secondary outcome is reduction in racial disparity in transplant referral .
CONCLUSIONS	The RaDIANT Community Study aims to improve equity in access to kidney transplantation for ESRD patients in the Southeast .
BACKGROUND	Clinicaltrials.gov number NCT02092727 .

###25481046
BACKGROUND	Atrial fibrillation ( AF ) is the most common arrhythmia .
BACKGROUND	NT-proBNP is a fragment of the prohormone brain natriuretic peptide .
BACKGROUND	Previous studies indicate that increased levels of NT-proBNP are associated with higher recurrence rates of AF after electrical cardioversion .
BACKGROUND	Our null hypothesis was that NT-proBNP does not predict recurrence of AF after restoration of sinus rhythm .
METHODS	We performed a hypothesis generating study within a double-blinded , placebo-controlled , randomized , prospective multicentre study of the effects of atorvastatin on recurrence of AF after electrical cardioversion .
METHODS	199 patients with persistent AF and an indication for cardioversion were included in the present substudy .
METHODS	NT-proBNP was assessed prior to cardioversion .
METHODS	Cardioversion was performed according to local standard clinical practice on an elective outpatient basis .
METHODS	Patients were followed-up one month after cardioversion .
RESULTS	181 patients had a successful cardioversion and 91 of the study group remained in sinus rhythm at day 30 .
RESULTS	Recurrence of AF was observed in 108 patients at day 30 .
RESULTS	An optimal cutpoint for NT-proBNP at 500 ng/L predicted recurrence of AF after cardioversion ( OR 2.94 ; 95 % CI 1.30-6 .63 ) .
RESULTS	In multivariate analysis adjusting for age , sex , hypertension , and treatment group strengthened the results ( OR 3,56 ; 95 % CI 1,44-8 ,81 ) .
RESULTS	When analysing the ROC curve of NT-proBNP in baseline and atrial fibrillation at day 30 the result was 0.57 .
CONCLUSIONS	NT-proBNP levels are a predictor of recurrence of AF 30 days after cardioversion .
CONCLUSIONS	ROC curves indicates that the practical value of NT-proBNP for the individual patient is limited .

###25253543
OBJECTIVE	The aim of this study was to evaluate the validity of a new apathy rating scale in predicting the ability to return to work ( RTW ) in patients with depression or anxiety a year after discharge from a psychiatric hospital .
METHODS	We evaluated 56 patients with depression or anxiety , who participated in an on-going randomised clinical trial using RTW as primary outcome .
METHODS	The degree of apathy was measured by the Diagnostic Apathia Scale , which contains six items covering the following neuropsychological symptoms : concentration/memory problems , difficulties in decision making , lassitude , tiredness/fatigue , insomnia , and reduced ability to work and engage in personal interests .
METHODS	The scale was analysed for psychometric validity ( scalability ) and for its ability to predict RTW .
METHODS	Finally , the predictive validity of the Diagnostic Apathia Scale regarding RTW was compared with scales measuring severity of depression/anxiety symptoms , disability , and psychological well-being .
RESULTS	The Diagnostic Apathia Scale displayed sufficient scalability , that is , the total score was a psychometrically valid measure of apathy .
RESULTS	Only the Diagnostic Apathia Scale , and not the scales measuring severity of symptoms , disability , or psychological well-being , had predictive validity regarding RTW .
RESULTS	Thus , 76 % with ` clinically significant apathy ' at baseline were unable to RTW versus 50 % of the patients without apathy ( p < 0.05 ) .
CONCLUSIONS	The Diagnostic Apathia Scale was found to have an acceptable predictive validity in terms of patients ' ability to RTW 1 year after discharge from hospitalisation for depression or anxiety .

###24673052
OBJECTIVE	To compare differences of therapeutic effect between acupuncture method of tonifying-qi and dredging-meridian and conventional acupuncture method .
METHODS	Seventy cases of blepharospasm were randomly divided into an observation group and a control group , 35 cases in each one .
METHODS	Cuanzhu ( BL 2 ) , Yuwei ( Extra ) through Yuyao ( EX-HN 4 ) , Xinming 1 ( Extra ) , Sibai ( ST 2 ) and Yintang ( GV 29 ) were selected as main acupoints .
METHODS	The acupuncture method of tonifying-qi and dredging-meridian was applied in the observation group , which was an acupuncture manipulation that could achieve strong needling sensation of qi arrival combined with electric-impulse stimulation .
METHODS	The conventional acupuncture method was applied in the control group .
METHODS	The treatment was given once every other day , 10 times as a session for continuous three sessions in both groups .
METHODS	The severity of blepharospasm was compared before and after treatment in two groups and clinical therapeutic effect was assessed .
METHODS	Follow-up visit was performed after half a year to observe the recurrence rate .
RESULTS	The cured and markedly effective rate was 77.1 % ( 27/35 ) in the observation group , which was superior to 51.4 % ( 18/35 ) in the control group ( P < 0.05 ) .
RESULTS	Among cured and markedly effective patients in both groups , the recurrence rate was 20.0 % ( 4/20 ) in the observation group , which was inferior to 54.5 % ( 6/11 ) in the control group ( P < 0.05 ) in the follow-up visit .
CONCLUSIONS	The acupuncture method of tonifying-qi and dredging-meridian could effectively improve severity of blepharospasm , which has superior short-term and long-term effects to conventional acupuncture method .

###25191967
BACKGROUND	Airway narrowing is maintained for a prolonged period after acute bronchoconstriction in humans in the absence of deep inspirations ( DIs ) .
OBJECTIVE	To determine whether maintenance of airway smooth muscle ( ASM ) shortening is responsible for the persistence of airway narrowing in healthy subjects following transient methacholine ( MCh ) - induced bronchoconstriction .
METHODS	On two separate visits , five healthy subjects underwent MCh challenges until respiratory system resistance ( Rrs ) had increased by approximately 1.5 cm H2O/L/s .
METHODS	Subjects took a DI either immediately after or 30 minutes after the last dose .
METHODS	The extent of renarrowing following the bronchodilator effect of DI was used to assess the continued action of MCh ( calculated as percent change in Rrs from the pre-DI Rrs ) .
METHODS	We then used human bronchial rings to determine whether ASM can maintain shortening during a progressive decrease of carbachol concentration .
RESULTS	The increased Rrs induced by MCh was maintained for 30 minutes despite waning of MCh concentration over that period , measured as attenuated renarrowing when the DI was taken 30 minutes after compared with immediately after the last dose ( 7 min post-DI , -36.2 11.8 vs. 14.4 13.2 % ; 12 min post-DI , -39.5 9.8 vs. 15.2 17.8 % ) .
RESULTS	Ex vivo , ASM shortening was largely maintained during a progressive decrease of carbachol concentration , even down to concentrations that would not be expected to induce shortening .
CONCLUSIONS	The maintenance of airway narrowing despite MCh clearance in humans is attributed to an intrinsic ability of ASM to maintain shortening during a progressive decrease of contractile stimulation .

###24726159
OBJECTIVE	To assess the effect of mitomycin-C ( MMC ) on the tear film , corneal biomechanics , and surface irregularity in surface ablation ( photorefractive keratectomy [ PRK ] ) for low to moderate myopia .
METHODS	Refractive Surgery Unit , Farabi Eye Hospital , Tehran , Iran .
METHODS	Double-masked randomized clinical trial .
METHODS	In patients with spherical equivalent myopia of -0.75 to -3.87 diopters ( D ) and astigmatism up to -1.75 D , the first eye was randomly assigned to the application of MMC 0.02 % or a balanced salt solution for 15 seconds .
METHODS	The fellow eye received the alternate in a masked fashion after excimer photoablation .
RESULTS	The study enrolled 60 patients .
RESULTS	In fellow eyes , the changes in the tear-film index were comparable 1 month and 6 months postoperatively .
RESULTS	There was no significant difference in changes in total higher-order aberrations , spherical aberration , coma , or Q values ( Pentacam HR ) between fellow eyes at 1 month and 6 months .
RESULTS	There was a trend toward a higher asymmetry index at 1 month ; however , a statistically significant drop was observed at 6 months in the MMC group ( P < .01 ) .
RESULTS	It was hypothesized that stromal remodeling was delayed , but better , in MMC-treated eyes .
RESULTS	No haze was recorded at 6 months in either group .
CONCLUSIONS	Use of MMC in PRK did not appear to contribute significantly to surface irregularity , transient tear-film dysfunction , or biomechanical weakening of the cornea compared with PRK without MMC .
BACKGROUND	No author has a financial or proprietary interest in any material or method mentioned .

###24295218
BACKGROUND	Self-instruction video ( SIV ) has been widely explored as a teaching mode for cardiopulmonary resuscitation ( CPR ) and automated external defibrillation ( AED ) , but not with other basic emergency skills .
OBJECTIVE	To evaluate the effectiveness of SIV in teaching other basic emergency skill in comparison with traditional face-to-face ( FTF ) methods .
METHODS	Participants were randomized into SIV and FTF groups .
METHODS	Each group was assigned to learn basic airway management ( BAM ) , cervical collar application ( CCA ) , manual cardiac defibrillation ( MCD ) , and emergency extremity splinting ( EES ) skills .
METHODS	Confidence level was assessed using questionnaires , and skills performances were assessed using calibrated-blinded assessors through an Objective Structured Clinical Examination ( OSCE ) .
RESULTS	Forty-five participants took part in the assessment exercises .
RESULTS	There were no significant differences between both groups , on all four skill categories .
RESULTS	The mean OSCE-score of an individual category between the FTF-group vs. the SIV-group were as follows : BAM ( 10.231.04 vs. 10.041.49 ; p = 0.62 ) ; CCA ( 7.864.39 vs. 7.134.12 ; p = 0.57 ) ; MCD ( 8.240.89 vs. 7.581.14 ; p = 0.39 ) ; EES ( 5.432.11 vs. 4.632.30 ; p = 0.23 ) .
RESULTS	The composite mean score for the FTF-group was 6.85 , and for the SIV-group was 6.20 ( p < 0.05 ) .
RESULTS	There was no significant different in the level of confidence for both groups .
CONCLUSIONS	SIV is as effective as FTF in teaching and learning basic emergency skills .

###24266299
BACKGROUND	Blood collection through intravenous lines frequently causes spurious hemolysis .
BACKGROUND	Due to specific structure , the tube holder Holdex ( Greiner Bio-One GmbH , Kremsmuenster , Austria ) is supposed to prevent erythrocyte injury in samples collected from catheters , so that we planned a specific study to support this hypothesis .
METHODS	Blood was collected from emergency department ( ED ) patients with 20-gauge catheter .
METHODS	In patients with odd order numbers , first and second tubes were collected with conventional holder ( BD Vacutainer One Use Holder , Becton Dickinson , Milan , Italy ) and the third with Holdex , whereas in even patients first and second tubes were drawn with Holdex and the third using BD Vacutainer One Use Holder .
METHODS	The first tube was discarded , whereas the second and third were centrifuged and serum was tested for potassium , lactate dehydrogenase ( LD ) and hemolysis index .
RESULTS	The final study population consisted in 60 ED patients .
RESULTS	Concentrations of potassium ( 4.25 vs. 4.16 mmol/L ; P = 0.031 ) , LD ( 498 vs. 459 U/L ; P = 0.039 ) and cell-free hemoglobin ( 0.42 vs. 0.22 g/L ; P = 0.042 ) were higher in samples collected with BD Vacutainer One Use Holder than with Holdex .
RESULTS	The mean bias of cell-free hemoglobin was -0.4 g/L in samples collected with Holdex .
RESULTS	Although the frequency of samples with cell-free hemoglobin > 0.5 g/L was identical ( 17/60 vs. 17/60 ; P = 1.00 ) , the frequency of those with concentrations > 3.0 g/L was higher using BD Vacutainer One Use Holder than Holdex ( 4/60 vs. 0/60 ; P = 0.042 ) .
CONCLUSIONS	The use of Holdex for drawing blood from intravenous lines may be effective for reducing gross hemolysis .

###24612987
OBJECTIVE	To prospectively compare norfloxacin ( N ) with trimethoprim-sulfamethoxazole ( T-S ) in preventing infection in cirrhotic patients .
METHODS	Cirrhotic patients at high risk of spontaneous bacterial peritonitis ( SBP ) were recruited and assigned N ( 400mg daily ) or T-S ( 160/800mg daily ) .
METHODS	Patients were followed up for 12 months .
METHODS	The primary end-point was the incidence of infection .
METHODS	Secondary end-points included the incidence of SBP , bacteremia , extraperitoneal infection requiring antibiotic treatment , liver transplantation , death , side effects and rate of resistance to N or T-S .
RESULTS	A total of 80 patients with a mean age of 53.09.3 years were prescribed N ( n = 40 ) or T-S ( n = 40 ) .
RESULTS	Child-Pugh status , model for end-stage liver disease and risk factors for SBP were similar between the groups .
RESULTS	There were 10 episodes of infections in the N group and 9 in the T-S group ( P = 0.79 ) .
RESULTS	Two patients each in the N and T-S group developed SBP ( P = 0.60 ) .
RESULTS	There was a difference in the rate of transplantation favoring N ( P = 0.03 ) but not death .
RESULTS	The number of adverse events for N ( n = 7 ) and T-S ( n = 10 ) were similar ( P = 0.59 ) , with T-S being associated with an increased risk of developing a definite or probable adverse event compared to N ( 22.5 % vs 0 % , P = 0.01 ) .
CONCLUSIONS	This study failed to demonstrate a difference between N and T-S groups in their effects on preventing infection in patients with liver cirrhosis .
CONCLUSIONS	T-S can be considered an alternative first-line therapy for infection prophylaxis .

###25027174
BACKGROUND	Anonymous survey methods appear to promote greater disclosure of sensitive or stigmatizing information compared to non-anonymous methods .
BACKGROUND	Higher disclosure rates have traditionally been interpreted as being more accurate than lower rates .
BACKGROUND	We examined the impact of 3 increasingly private mailed survey conditions-ranging from potentially identifiable to completely anonymous-on survey response and on respondents ' representativeness of the underlying sampling frame , completeness in answering sensitive survey items , and disclosure of sensitive information .
BACKGROUND	We also examined the impact of 2 incentives ( $ 10 versus $ 20 ) on these outcomes .
METHODS	A 3X2 factorial , randomized controlled trial of 324 representatively selected , male Gulf War I era veterans who had applied for United States Department of Veterans Affairs ( VA ) disability benefits .
METHODS	Men were asked about past sexual assault experiences , childhood abuse , combat , other traumas , mental health symptoms , and sexual orientation .
METHODS	We used a novel technique , the pre-merged questionnaire , to link anonymous responses to administrative data .
RESULTS	Response rates ranged from 56.0 % to 63.3 % across privacy conditions ( p = 0.49 ) and from 52.8 % to 68.1 % across incentives ( p = 0.007 ) .
RESULTS	Respondents ' characteristics differed by privacy and by incentive assignments , with completely anonymous respondents and $ 20 respondents appearing least different from their non-respondent counterparts .
RESULTS	Survey completeness did not differ by privacy or by incentive .
RESULTS	No clear pattern of disclosing sensitive information by privacy condition or by incentive emerged .
RESULTS	For example , although all respondents came from the same sampling frame , estimates of sexual abuse ranged from 13.6 % to 33.3 % across privacy conditions , with the highest estimate coming from the intermediate privacy condition ( p = 0.007 ) .
CONCLUSIONS	Greater privacy and larger incentives do not necessarily result in higher disclosure rates of sensitive information than lesser privacy and lower incentives .
CONCLUSIONS	Furthermore , disclosure of sensitive or stigmatizing information under differing privacy conditions may have less to do with promoting or impeding participants ' `` honesty '' or `` accuracy '' than with selectively recruiting or attracting subpopulations that are higher or lower in such experiences .
CONCLUSIONS	Pre-merged questionnaires bypassed many historical limitations of anonymous surveys and hold promise for exploring non-response issues in future research .

###25291130
BACKGROUND	Leaky gut , or intestinal permeability , is the phenomenon of the gut wall exhibiting increased absorbency .
BACKGROUND	It is pretty well recognised that an altered or damaged bowel lining or gut wall may result from unbalanced diet , parasites , infection , or medications and that this allows substances such as toxins , microbes , undigested food , or waste to leak through .
BACKGROUND	As a natural consequence , this prompts the body to initiate an immune reaction leading to potentially severe health conditions .
BACKGROUND	Different strategies may be used to improve , at least temporarily , the physiological intestinal barrier .
BACKGROUND	The use of specific beneficial microorganisms , such as lactobacilli and bifidobacteria , has been suggested as an innovative tool to counteract an improper level of intestinal permeability .
BACKGROUND	The association of bacteria with specific gelling agents , such as gums , may represent an improvement since these molecules are able to form hydrophilic gels that distribute uniformly over the inner intestinal surface .
BACKGROUND	This pilot study was undertaken to evaluate intestinal permeability in subjects treated with a gelling complex , an association of tara gum and the microorganism Streptococcus thermophilus ST10 ( DSM 25246 ) , which has a well-demonstrated in vitro ability to synthesise and secrete exopolysaccharides ( EPSs ) .
METHODS	Twenty-five healthy subjects were enrolled in this human intervention , double-blind , placebo-controlled , pilot trial ( age between 21 and 57 y , mean 37.711.2 ) .
METHODS	Subjects were then randomised into 2 groups : group A ( 13 subjects ) was given an active formulation containing 250 mg of tara gum and 1 billion viable cells of S. thermophilus ST10 , whereas group B ( 12 subjects ) was given a placebo formulation .
METHODS	All the subjects participating in the study were directed to take 1 dose per day for 30 consecutive days .
METHODS	The presence and concentration of exopolysaccharides ( EPSs ) in the faeces was determined at time 0 ( d0 ) , after 30 days of treatment ( d30 ) , and at the end of the 2-week follow-up period ( d45 ) .
METHODS	The monosaccharide composition of EPSs was used to quantify the possible contribution of tara gum to the amount of polysaccharides detected in the faecal material .
METHODS	Intestinal permeability was evaluated at the same time by means of the lactitol/mannitol ratio ( small intestine permeability ) and sucralose concentration ( colonic permeability ) in urine specimens sampled after specified times .
METHODS	A statistical comparison was made between the concentration of EPSs , the lactulose/mannitol ratio , and the amount of excreted sucralose in the 2 groups at d0 , d30 , and d45 .
RESULTS	In the active group , supplementation with S. thermophilus ST10 and tara gum was able to significantly increase the faecal EPSs concentration compared with placebo ( from 0.169 mg/g to 0.633 mg/g after 30 d , P < 0.001 ) .
RESULTS	An interesting decrease in intestinal permeability , both of the small bowel and in the colon , was also recorded .
RESULTS	The L/M ratio diminished from 0.021 in the active group to 0.014 and 0.015 after 30 and 45 days , respectively ( P = 0.045 and P = 0.033 compared with placebo ) .
RESULTS	The sucralose concentration decreased from 35.8 mg to 27.9 mg and 29.1 mg ( P = 0.038 and P = 0.026 compared with placebo ) at the end of the supplementation period and after the follow-up , respectively .
RESULTS	No significant differences were recorded in the placebo after 30 days or at the end of the follow-up .
CONCLUSIONS	The association of the EPSs produced by S. thermophilus ST10 and tara gum seems capable of significantly improving the intestinal functional barrier in healthy subjects .
CONCLUSIONS	A wider study in subjects presenting impaired gut permeability would be useful in the future to confirm the positive results from this pilot trial .
CONCLUSIONS	In any case , our findings are consistent with the parallel increase in exopolysaccharide concentration in the faecal material , thus suggesting the effective ability of the strain used to secrete EPSs in the gut lumen .
CONCLUSIONS	An innovative approach of this type may be useful in helping to restore the physiological barrier by means of a merely natural and mechanical action .

###24731620
OBJECTIVE	Studies in healthy individuals show that exerting self-control consumes cognitive resources , which reduces subsequent self-control performance .
OBJECTIVE	Restoring the availability of blood glucose eliminates this impairment .
OBJECTIVE	Patients with schizophrenia are found to have self-regulatory dysfunctions .
OBJECTIVE	This study aims to investigate whether patient 's ( a ) glucose facilitation effects will be impaired , and ( b ) will have exaggerated depletion in a self-control task .
METHODS	40 patients with schizophrenia-spectrum disorders and 40 normal controls were recruited .
METHODS	A two drinks ( glucose vs. placebo ) two depleting phases ( self-control depleted vs. non-depleted ) between-groups design was used .
METHODS	We examined the blood glucose levels before and after the selfcontrol depletion phase and the subsequent performances in two self-control tasks ( handgrip and Stroop tests ) after the drink condition .
RESULTS	The four groups ( depletingglucose , depletingplacebo , non-depletingglucose and nondepletingplacebo ) of both patients and normal controls were comparable on a number of characteristics .
RESULTS	The change in blood glucose level in the depleting group was significantly different from those in the non-depleting group .
RESULTS	Twotwo between-subjects ANOVAs were carried out to test the performances in the handgrip and Stroop tasks .
RESULTS	Significant interactions were found in healthy controls regarding both tasks .
RESULTS	However , a significant interaction was only found in patients regarding the handgrip task but not the Stroop task .
CONCLUSIONS	This study demonstrated an abnormal glucose facilitation effect in patients during a cognitive self-control task but not during a physical self-control task .
CONCLUSIONS	The findings also suggested for the first time that a self-control depletion effect is intact in patients with schizophrenia .

###25010536
OBJECTIVE	To investigate the neurobehavioral pattern of recovery of consciousness as reflected by performance on the subscales of the Coma Recovery Scale-Revised ( CRS-R ) .
METHODS	Retrospective item response theory ( IRT ) and factor analysis .
METHODS	Inpatient rehabilitation facilities .
METHODS	Rehabilitation inpatients ( N = 180 ) with posttraumatic disturbance in consciousness who participated in a double-blinded , randomized , controlled drug trial .
METHODS	Not applicable .
METHODS	Scores on CRS-R subscales .
RESULTS	The CRS-R was found to fit factor analytic models adhering to the assumptions of unidimensionality and monotonicity .
RESULTS	In addition , subscales were mutually independent based on residual correlations .
RESULTS	Nonparametric IRT reaffirmed the finding of monotonicity .
RESULTS	A highly constrained confirmatory factor analysis model , which imposed equal factor loadings on all items , was found to fit the data well and was used to estimate a 1-parameter IRT model .
CONCLUSIONS	This study provides evidence of the unidimensionality of the CRS-R and supports the hierarchical structure of the CRS-R subscales , suggesting that it is an effective tool for establishing diagnosis and monitoring recovery of consciousness after severe traumatic brain injury .

###25073598
BACKGROUND	A hamstring injury is one of the most common types of injury affecting athletes .
BACKGROUND	Despite this , the optimal management of hamstring muscle injuries is not yet defined .
BACKGROUND	The effect of autologous platelet-rich plasma ( PRP ) therapy on the recovery of hamstring injuries is unclear .
OBJECTIVE	To investigate the effect of a single PRP injection in the treatment of grade 2 hamstring muscle injuries .
METHODS	Randomized controlled trial ; Level of evidence , 2 .
METHODS	Twenty-eight patients diagnosed with an acute hamstring injury were randomly allocated to autologous PRP therapy combined with a rehabilitation program or a rehabilitation program only .
METHODS	The primary outcome of this study was time to return to play .
METHODS	In addition , changes in pain severity and pain interference scores over time were examined .
RESULTS	Patients in the PRP group achieved full recovery significantly earlier than controls ( P = .02 ) .
RESULTS	The mean time to return to play was 26.7 7.0 days and 42.5 20.6 days for the PRP and control groups , respectively ( t ( 22 ) = 2.50 , P = .02 ) .
RESULTS	[ corrected ] .
RESULTS	Significantly lower pain severity scores were observed in the PRP group throughout the study .
RESULTS	However , no significant difference in the pain interference score was found between the 2 groups .
CONCLUSIONS	A single autologous PRP injection combined with a rehabilitation program was significantly more effective in treating hamstring injuries than a rehabilitation program alone .

###24368552
BACKGROUND	Many environmental and dietary influences can cause immune cells to produce biological mediators that increase airway inflammation .
BACKGROUND	A high-fat meal ( HFM ) is one stimulus that increases airway inflammation in healthy individuals .
BACKGROUND	Supplementation with omega-3 fatty acids can reduce inflammation systemically and may be beneficial to the airways .
OBJECTIVE	To determine if omega-3 fatty acid supplementation via fish oil would mitigate the airway inflammatory response induced by a single HFM .
METHODS	Seventeen non-asthmatic men ( 22 2 years . )
METHODS	were supplemented with 3,000 mg day ( -1 ) fish oil or a placebo for 3 weeks .
METHODS	Fractional exhaled nitric oxide ( FENO ; a marker of airway inflammation ) , impulse oscillometry ( a measure of respiratory impedance ) , pulmonary function , and triglycerides were measured prior to and 2 h following a HFM .
RESULTS	Following a HFM , triglycerides increased in both fish oil and placebo groups compared to pre-HFM ( ~ 59 and ~ 49 % , respectively , p < 0.05 ) .
RESULTS	The percent increase in FENO was greater in the placebo group compared to the fish oil group ( 25.7 16.7 vs. -1.99 10.5 % , respectively , p < 0.05 ) .
RESULTS	A significant correlation was observed between blood triglycerides and FENO in the placebo group ( r = 0.61 ; p < 0.05 ) , but not the fish oil group ( p = 0.21 ) .
CONCLUSIONS	A single HFM increases airway inflammation and omega-3 fatty acid supplementation via fish oil protects against HFM associated changes in airway health .

###24794243
BACKGROUND	Preclinical data suggest that triple-negative breast cancers are sensitive to interstrand crosslinking agents , and that synergy may exist for the combination of a taxane , trastuzumab , and a platinum salt for HER2-positive breast cancer .
BACKGROUND	We therefore aimed to assess the efficacy of the addition of carboplatin to neoadjuvant therapy for triple-negative and HER2-positive breast cancer .
METHODS	Patients with previously untreated , non-metastatic , stage II-III , triple-negative breast cancer and HER2-positive breast cancer were enrolled .
METHODS	Patients were treated for 18 weeks with paclitaxel ( 80 mg/m ( 2 ) once a week ) and non-pegylated liposomal doxorubicin ( 20 mg/m ( 2 ) once a week ) .
METHODS	Patients with triple-negative breast cancer received simultaneous bevacizumab ( 15 mg/kg intravenously every 3 weeks ) .
METHODS	Patients with HER2-positive disease received simultaneous trastuzumab ( 8 mg/kg initial dose with subsequent doses of 6 mg/kg intravenously every 3 weeks ) and lapatinib ( 750 mg daily ) .
METHODS	Patients were randomly assigned in a 1:1 ratio with dynamic allocation and minimisation , stratified by biological subtype and Ki-67 level to receive , at the same time as the backbone regimens , either carboplatin ( AUC 15 [ 20 for the first 329 patients ] once a week ) or no carboplatin .
METHODS	The primary endpoint the proportion of patients who achieved a pathological complete response ( defined as ypT0 ypN0 ) , analysed for all patients who started treatment ; a p value of less than 02 was deemed significant for the primary endpoint .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01426880 .
RESULTS	296 patients were randomly assigned to receive carboplatin and 299 to no additional carboplatin , of whom 295 and 293 started treatment , respectively .
RESULTS	In this final analysis , 129 patients ( 437 % , 95 % CI 381-494 ) in the carboplatin group achieved a pathological complete response , compared with 108 patients ( 369 % , 313-424 ) without carboplatin ( odds ratio 133 , 95 % CI 096-185 ; p = 0107 ) .
RESULTS	Of the patients with triple-negative breast cancer , 84 ( 532 % , 544-609 ) of 158 patients achieved a pathological complete response with carboplatin , compared with 58 ( 369 % , 294-445 ) of 157 without ( p = 0005 ) .
RESULTS	Of the patients with HER2-positive tumours , 45 ( 328 % , 250-407 ) of 137 patients achieved a pathological complete response with carboplatin compared with 50 ( 368 % , 287-449 ) of 136 without ( p = 0581 ; test for interaction p = 0015 ) .
RESULTS	Haematological and non-haematological toxic effects that were significantly more common in the carboplatin group than in the no-carboplatin group included grade 3 or 4 neutropenia ( 192 [ 65 % ] vs 79 [ 27 % ] ) , grade 3 or 4 anaemia ( 45 [ 15 % ] vs one [ < 1 % ] ) , grade 3 or 4 thrombocytopenia ( 42 [ 14 % ] vs one [ < 1 % ] ) , and grade 3 or 4 diarrhoea ( 51 [ 17 % ] vs 32 [ 11 % ] ) ; carboplatin was more often associated with dose discontinuations ( 141 [ 48 % ] with carboplatin and 114 [ 39 % ] without carboplatin ; p = 0031 ) .
RESULTS	The frequency of grade 3 or 4 haematological events decreased from 82 % ( n = 135 ) to 70 % ( n = 92 ) and grade 3 or 4 non-haematological events from 78 % ( n = 128 ) to 59 % ( n = 77 ) in the carboplatin arm when the dose of carboplatin was reduced from AUC 20 to 15 .
CONCLUSIONS	The addition of neoadjuvant carboplatin to a regimen of a taxane , an anthracycline , and targeted therapy significantly increases the proportion of patients achieving a pathological complete response .
CONCLUSIONS	This regimen seems to increase responses in patients with triple-negative breast cancer , but not in those with HER2-positive breast cancer .
BACKGROUND	GlaxoSmithKline , Roche , and Teva .

###24824893
OBJECTIVE	To compare change in dietary intake , with an emphasis on food groups and food intake behaviour , over time across treatment arms in a diabetes prevention trial and to assess the differences in dietary intake among demographic groups within treatment arms .
METHODS	Data are from the Diabetes Prevention Program and Diabetes Prevention Program Outcomes Study .
METHODS	Participants were randomized to a lifestyle intervention ( n = 1079 ) , metformin ( n = 1073 ) or placebo ( n = 1082 ) for an average of 3years , after which the initial results regarding the benefits of the lifestyle intervention were released and all participants were offered a modified lifestyle intervention .
METHODS	Dietary intake was assessed using a food frequency questionnaire at baseline and at 1 , 5 , 6 and 9years after randomization .
RESULTS	Compared with the metformin and placebo arms , participants in the lifestyle arm maintained a lower total fat and saturated fat and a higher fibre intake up to 9years after randomization and lower intakes of red meat and sweets were maintained for up to 5years .
RESULTS	Younger participants had higher intakes of poultry and lower intakes of fruits compared with their older counterparts , particularly in the lifestyle arm .
RESULTS	Black participants tended to have lower dairy and higher poultry intakes compared with white and Hispanic participants .
RESULTS	In the lifestyle arm , men tended to have higher grain , fruit and fish intakes than women .
CONCLUSIONS	Changes in nutrient intake among participants in the lifestyle intervention were maintained for up to 9years .
CONCLUSIONS	Younger participants reported more unhealthy diets over time and thus may benefit from additional support to achieve and maintain dietary goals .

###24767519
BACKGROUND	Physical exercise training aims at reducing disease-specific impairments and improving quality of life in patients with chronic obstructive pulmonary disease ( COPD ) .
BACKGROUND	COPD exacerbations in particular negatively impact COPD progression .
BACKGROUND	Physical therapy intervention seems indicated to influence exacerbations and their consequences .
BACKGROUND	However , information on the effect of physical therapy on exacerbation occurrence is scarce .
BACKGROUND	This study aims to investigate the potential of a protocol-directed physical therapy programme as a means to prevent or postpone exacerbations , to shorten the duration or to decrease the severity of exacerbations in patients with COPD who have recently experienced an exacerbation .
BACKGROUND	Besides , this study focuses on the effect of protocol-directed physical therapy on health status and quality of life and on cost-effectiveness and cost-utility in patients with COPD who have recently experienced an exacerbation .
METHODS	A prospective cohort of 300 COPD patients in all GOLD stages will be constructed .
METHODS	Patients will receive usual multidisciplinary COPD care including guideline-directed physical therapy .
METHODS	Patients in this cohort who have GOLD stage 2 to 4 ( post-bronchodilator FEV1/FVC < 0.7 and FEV1 < 80 % of predicted ) , who receive reimbursement by health insurance companies for physical therapy ( post-bronchodilator Tiffeneau-index < 0.6 ) and who experience a COPD exacerbation will be asked within 56 days to participate in a cohort-nested prospective randomised controlled trial ( RCT ) .
METHODS	In this RCT , the intervention group will receive a strict physical therapy programme for patients with COPD .
METHODS	This protocol-directed physical therapy ( pdPT ) will be compared to a control group that will receive sham-treatment , meaning no or very low-intensity exercise training ( ST ) .
METHODS	An economic evaluation will be embedded in the RCT .
METHODS	Anthropometric measurements , comorbidities , smoking , functional exercise capacity , peripheral muscle strength , physical activity level , health related quality of life , patients ' perceived benefit , physical therapy compliance , motivation level , level of effective mucus clearance , exacerbation symptoms and health care contacts due to COPD will be recorded .
METHODS	Follow-up measurements are scheduled at 3 and 6 weeks , 3 , 6 , 12 and 24 months after inclusion .
CONCLUSIONS	Ways to minimise potential problems regarding the execution of this study will be discussed .
BACKGROUND	The Netherlands National Trial Register NTR1972 .

###24569538
OBJECTIVE	An imbalance between Th1 and Th2 cells is involved in allergic rhinitis ( AR ) that may be improved by probiotics .
OBJECTIVE	To test the efficacy of the probiotic Lactobacillus paracasei subsp .
OBJECTIVE	paracasei LP-33 , a double-blind , placebo-controlled , randomized trial was carried out in patients with AR to grass pollen treated with loratadine and presenting altered quality of life .
METHODS	Subjects with persistent AR , symptomatic during the grass pollen season , and a positive skin test or specific immunoglobulin E to grass pollens were included by general practitioners ( GPs ) .
METHODS	All received loratadine for 5 weeks .
METHODS	The primary end point was the improvement in Rhinitis Quality of Life ( RQLQ ) global score at the fifth week of LP-33 consumption compared with placebo ( in addition to loratadine ) .
METHODS	Secondary end points included nasal and ocular symptoms ( individual and total symptom scores ) , visual analogue scale and time of first exacerbation of the symptoms when loratadine was stopped .
RESULTS	A total of 425 subjects were included .
RESULTS	Using intent-to-treat analysis , the RQLQ global score decreased significantly more in the LP-33 group than in the placebo group ( P = 0.0255 , difference = -0.286 ( 95 % confidence interval ( CI ) : -0.536 ; -0.035 ) ) .
RESULTS	No significant differences were noted for the change of the rhinitis total symptom score 5 global score between groups ( P = 0.1288 , difference = -0.452 ( 95 % CI : -1.036 ; 0.132 ) ) .
RESULTS	Significant differences in ocular symptoms ( RQLQ ) were observed between groups ( P = 0.0029 , difference = -0.4087 ( 95 % CI : -0.6768 ; -0.1407 ) ) .
CONCLUSIONS	This study performed by GPs shows that LP-33 improves the quality of life of subjects with persistent AR who are currently being treated with an oral H1-antihistamine .
CONCLUSIONS	Whereas nasal symptoms had not changed , ocular symptoms had consistently improved .

###24334179
BACKGROUND	HIV-associated diarrhea remains a significant concern with limited treatment options .
OBJECTIVE	To determine the optimal dose , efficacy , and safety of crofelemer for noninfectious diarrhea .
METHODS	This randomized , double-blind , phase 3 trial used a 2-stage design .
METHODS	Both stages included 2-week screening , 4-week placebo-controlled treatment , and 20-week placebo-free ( open-label ) extension phases .
METHODS	In stage I , 196 HIV-seropositive patients with chronic diarrhea were randomized to crofelemer 125 mg , 250 mg , or 500 mg or placebo twice daily .
METHODS	Using a prospective analysis , the 125-mg twice-daily dose was selected for stage II .
METHODS	In stage II , 180 new patients were randomized to crofelemer 125 mg twice daily or placebo for 4 weeks .
METHODS	Primary efficacy analysis was the percentage of patients ( stages I/II combined ) who achieved clinical response ( defined as 2 watery stools/week during 2 of 4 weeks ) .
METHODS	During the placebo-free extension phase , response ( 2 watery stools ) was assessed weekly .
RESULTS	Significantly more patients receiving crofelemer 125 mg achieved clinical response versus placebo ( 17.6 % vs 8.0 % ; one-sided , P = .01 ) .
RESULTS	Crofelemer 125 mg resulted in a greater change from baseline in number of daily watery bowel movements ( P = .04 ) and daily stool consistency score ( P = .02 ) versus placebo .
RESULTS	During the placebo-free extension phase , percentages of weekly responders ranged from 40 % to 56 % at weeks 11 to 24 .
RESULTS	Crofelemer was minimally absorbed , well tolerated , did not negatively impact clinical immune parameters , and had a safety profile comparable to placebo .
CONCLUSIONS	In HIV-seropositive patients taking stable antiretroviral therapy , crofelemer provided significant improvement in diarrhea with a favorable safety profile .

###25439415
OBJECTIVE	To examine the influence of epidural and intravenous ( IV ) lidocaine , and height of the epidural sensory block , on the dose of propofol required for induction of general anesthesia .
METHODS	Randomized controlled study .
METHODS	University hospital .
METHODS	66 adult , ASA physical status 1 and 2 patients , aged 25 to 65 years , undergoing elective abdominal surgery .
METHODS	Patients were randomized to 4 groups : the epidural saline control group ( Group C ; L2-L3 puncture , epidural and IV saline ) , the IV lidocaine group ( Group IV ; L2-L3 puncture , saline epidural , IV lidocaine 1 mg/kg ) , the lumbar epidural lidocaine group ( Group EL ; L2-L3 puncture , 1.5 % lidocaine epidural , IV saline ) , and the thoracic epidural lidocaine group ( Group ET ; T9-T10 puncture , 1.5 % lidocaine epidural , IV saline ) .
METHODS	Two minutes after the beginning of the infusion of IV lidocaine or saline , propofol anesthesia was initiated .
METHODS	Mean arterial blood pressure ( MAP ) , heart rate ( HR ) , and sensory block height were monitored .
METHODS	The induction dose of propofol , its estimated effect-site concentration ( Ce ) , and plasma concentration were measured at various time points .
METHODS	Finally , we recorded the time taken for the bispectral index ( BIS ) to decrease to 60 , the plasma concentration of lidocaine at induction , and the occurrence of adverse events .
METHODS	The induction time ( when BIS reached 60 ) also was recorded .
RESULTS	The induction propofol dose , Ce , and plasma concentration of propofol when BIS equaled 60 were significantly lower in Group IV , Group EL , and Group ET than Group C.
RESULTS	The above parameters in Group ET ( T9 - T10 puncture ) were significantly less than in Group EL ( L2 - L3 puncture ) .
RESULTS	The induction doses of propofol and plasma concentration of propofol and lidocaine were significantly higher in Group IV than in Groups EL or ET .
CONCLUSIONS	Epidural and IV lidocaine reduce the dose of propofol required to induce general anesthesia .
CONCLUSIONS	Administration of lidocaine via the epidural route reduces anesthetic requirements more so than the IV route .
CONCLUSIONS	Propofol requirements were further reduced in patients with higher sensory epidural block .

###24478399
OBJECTIVE	This study sought to identify the profile of circulating microRNAs ( miRNAs ) in type 2 diabetes ( T2D ) and its response to changes in insulin sensitivity .
METHODS	The circulating miRNA profile was assessed in a pilot study of 12 men : 6 with normal glucose tolerance ( NGT ) and 6 T2D patients .
METHODS	The association of 10 circulating miRNAs with T2D was cross-sectionally validated in an extended sample of 45 NGT vs. 48 T2D subjects ( 65 nonobese and 28 obese men ) and longitudinally in 35 T2D patients who were recruited in a randomized , double-blinded , and placebo-controlled 3-month trial of metformin treatment .
METHODS	Circulating miRNAs were also measured in seven healthy volunteers before and after a 6-h hyperinsulinemic-euglycemic clamp and insulin plus intralipid/heparin infusion .
RESULTS	Cross-sectional studies disclosed a marked increase of miR-140-5p , miR-142-3p , and miR-222 and decreased miR-423-5p , miR-125b , miR-192 , miR-195 , miR-130b , miR-532-5p , and miR-126 in T2D patients .
RESULTS	Multiple linear regression analyses revealed that miR-140-5p and miR-423-5p contributed independently to explain 49.5 % ( P < 0.0001 ) of fasting glucose variance after controlling for confounders .
RESULTS	A discriminant function of four miRNAs ( miR-140-5p , miR-423-5p , miR-195 , and miR-126 ) was specific for T2D with an accuracy of 89.2 % ( P < 0.0001 ) .
RESULTS	Metformin ( but not placebo ) led to significant changes in circulating miR-192 ( 49.5 % ; P = 0.022 ) , miR-140-5p ( -15.8 % ; P = 0.004 ) , and miR-222 ( -47.2 % ; P = 0.03 ) , in parallel to decreased fasting glucose and HbA1c .
RESULTS	Furthermore , while insulin infusion during clamp decreased miR-222 ( -62 % ; P = 0.002 ) , the intralipid/heparin mixture increased circulating miR-222 ( 163 % ; P = 0.015 ) and miR-140-5p ( 67.5 % ; P = 0.05 ) .
CONCLUSIONS	This study depicts the close association between variations in circulating miRNAs and T2D and their potential relevance in insulin sensitivity .

###24966227
BACKGROUND	Previous studies indicated that a single session of repeated-slip exposure can reduce over 40 % of laboratory-induced falls among older adults .
BACKGROUND	The purpose of this study was to determine to what degree such perturbation training translated to the reduction of older adults ' annual falls risk in their everyday living .
METHODS	Two hundred and twelve community-dwelling older adults ( 65 years old ) were randomly assigned to either the training group ( N = 109 ) , who then were exposed to 24 unannounced repeated slips , or the control group ( N = 103 ) , who merely experienced one slip during the same walking in the same protective laboratory environment .
METHODS	We recorded their falls in the preceding year ( through self-reported history ) and during the next 12 months ( through falls diary and monitored with phone calls ) .
RESULTS	With this single session of repeated-slip exposure , training cut older adults ' annual risk of falls by 50 % ( from 34 % to 15 % , p < .05 ) .
RESULTS	Those who experienced merely a single slip were 2.3 times more likely to fall during the same 12-month follow-up period ( p < .05 ) than those who experienced the 24 repeated slips .
RESULTS	Such training effect was especially prominent among those who had history of falls .
CONCLUSIONS	A single session of repeated-slip exposure could improve community-dwelling older adults ' resilience to postural disturbances and , hence , significantly reduce their annual risk of falls .

###24519692
OBJECTIVE	The effect of antipsychotics ( APs ) on negative symptoms is controversial .
OBJECTIVE	The present study assessed negative symptoms in healthy volunteers without any source of primary negative symptoms after single doses of haloperidol and risperidone .
METHODS	Twenty-five healthy subjects were included in this randomized , placebo-controlled , single-dose ( haloperidol 5mg and risperidone 2.5 mg ) crossover and double-blind clinical trial .
METHODS	Negative symptoms were assessed by observer-rated scales and with a self-report scale .
METHODS	Possible confounding effects considered were extrapyramidal symptoms ( EPS ) and sedative effects .
METHODS	The occupation of striatal dopamine D2 receptors was also determined .
RESULTS	Risperidone induced a wide range of negative symptoms such as alogia , blunted affect , avolition/apathy , and attention impairment , whereas haloperidol only induced the avolition/apathy subdomain .
RESULTS	Most of the effects of risperidone in healthy volunteers , with the exception of its effects on avolition/apathy , were attributable to AP-induced EPS .
RESULTS	Haloperidol did not cause significant EPS after administration .
RESULTS	No effect of sedation or psychomotor performance was observed on negative symptoms .
CONCLUSIONS	Single doses of both haloperidol and risperidone induced nonmotor secondary negative symptoms in healthy volunteers .
CONCLUSIONS	The clinical findings are especially relevant in view of the impact of negative symptoms on poor functioning .
CONCLUSIONS	They may help to guide clinicians in their choice of APs ( http://clinicaltrials.gov/ct2/show/NCT01259973 ) .

###25168762
BACKGROUND	Increasing physical activity is known to have health benefits for people with hypertension and related conditions .
BACKGROUND	Current general practitioner referrals for gym-based exercise increase physical activity but meta-analyses show that while these are effective the absolute health risk reduction is small due to patients failing to maintain activity levels over time .
BACKGROUND	This study assesses the effectiveness of two sports-oriented interventions that are intended to bridge the intention-behaviour gap and thus increase the likelihood of sustained increases in physical activity .
METHODS	Four-arm randomised controlled trial .
METHODS	The study tests two types of intervention that are intended to increase physical activity among currently inactive 18 - to 74-year-old people with hypertension or high-normal blood pressure .
METHODS	This study will assess the effectiveness of a 12-week sports-oriented exercise programme , the efficacy of a web-delivered self-help tool to promote and support sports participation and healthy behaviour change and the effect of these interventions in combination .
METHODS	The control arm will be a standard care general practitioner referral for gym-based exercise .
METHODS	Participants will be allocated using block randomisation .
METHODS	The first author and primary analyst is blinded to participant allocation .
METHODS	The primary outcome measures will be time spent in physical activity assessed in metabolic equivalent minutes per week using the International Physical Activity Questionnaire 1year after commencement of the intervention .
METHODS	Secondary outcomes include increased involvement in sporting activity and biomedical health outcomes including change in body mass index , and waist and hip measurement and reductions in blood pressure .
CONCLUSIONS	If proven to be superior to general practitioner referrals for gym-based exercise , these sports-oriented interventions would constitute low-cost alternatives .
CONCLUSIONS	The next stage would be a full economic evaluation of the interventions .
BACKGROUND	Current Controlled Trials ISRCTN71952900 ( 7 June 2013 ) .

###24710321
OBJECTIVE	We aimed to investigate the association between baseline plasma fatty acids profile and the risk of future major cardiovascular events in patients with a history of ischaemic heart disease or ischemic stroke .
METHODS	Baseline plasma fatty acids as well as established cardiovascular risk factors were measured in 2,263 patients enrolled in the SUpplementation with FOLate , vitamins B-6 and B-12 and/or OMega-3 fatty acids randomized controlled trial .
METHODS	Incident major cardiovascular , cardiac and cerebrovascular events were ascertained during the 4.7 years of follow up .
METHODS	Hazard ratios were obtained from Cox proportional hazards models after adjustment for cardiovascular risk factors .
RESULTS	During the follow-up , 154 , 379 and 84 patients had major cardiovascular , cardiac and cerebrovascular events respectively .
RESULTS	Upon adjustment for gender , initial event , baseline age and BMI , the risk of developing a major cardiovascular event decreased significantly in successive quartiles of arachidonic acid ( P trend < 0.002 ) , total omega 3 polyunsaturated fatty acids ( P trend < 0.03 ) , docosapentaenoic acid ( P trend < 0.019 ) , docosahexaenoic acid ( P trend < 0.004 ) , eicosapentaenoic acid + docosahexaenoic acid ( P trend < 0.03 ) and eicosapentaenoic acid + docosapentaenoic acid + docosahexaenoic acid ( P trend < 0.02 ) .
RESULTS	This inverse association was borderline significant with increased quartiles of stearidonic acid ( P trend < 0.06 ) .
RESULTS	In the full model , only stearidonic acid remained inversely associated with the risk of developing a major cardiovascular event ( P trend < 0.035 ) , a cardiac event ( P trend < 0.016 ) or a cerebrovascular event ( P trend < 0.014 ) , while arachidonic acid was inversely associated with the risk a cerebrovascular event ( P trend < 0.033 ) .
CONCLUSIONS	The inverse association of long chain omega 3 polyunsaturated fatty acids with recurrence of Cardiovascular diseases was mainly driven by well-known cardiovascular risk factors .
BACKGROUND	Controlled-Trials .
BACKGROUND	com ISRCTN41926726 .

###24861853
OBJECTIVE	Evaluate the pharmacokinetics ( PK ) , safety , and tolerability of single doses of once-daily USL255 , Qudexy XR ( topiramate ) extended-release capsules , over a wide dosing range .
METHODS	Two single-dose , phase I studies in healthy adults were used to evaluate the PK profile and maximum tolerated dose ( MTD ) of USL255 from 25-1 ,400 mg .
METHODS	Standard PK parameters assessed included area under the plasma concentration-time curve ( AUC ) and maximum plasma concentration ( Cmax ) .
METHODS	Dose proportionality , linearity , and intersubject and intrasubject variability ( coefficient of variation [ % CV ] ) of AUC and Cmax were evaluated .
METHODS	Investigator-reported adverse events ( AEs ) were obtained throughout the studies .
RESULTS	After the initial increase in plasma concentration levels immediately following administration of USL255 25-1 ,400 mg , plasma topiramate concentration-time profiles were flat up to 24 h after dosing .
RESULTS	AUC was dose proportional from 25-1 ,400 mg , and Cmax was dose proportional from 50-1 ,400 mg ; both AUC and Cmax were linear across the entire dose range .
RESULTS	Low intersubject and intrasubject % CV values were observed for AUC0-t , AUC0 - , and Cmax ( intersubject % CV : 20.2 , 19.6 , and 22.4 % , respectively ; intrasubject % CV of dose-normalized mean values : 10.8 , 8.2 , and 13.2 % , respectively ) .
RESULTS	USL255 was generally safe and well tolerated with MTD established at 1,200 mg .
CONCLUSIONS	These results demonstrate that USL255 provides consistent plasma topiramate exposure across an extended-dosing interval and predictable plasma topiramate concentrations over a wide dosing range .
CONCLUSIONS	Overall , the favorable safety profile and consistency of exposure suggest once-daily USL255 can be a useful treatment option for patients with epilepsy .

###25760354
BACKGROUND	Whether a restrictive threshold for hemoglobin level in red-cell transfusions , as compared with a liberal threshold , reduces postoperative morbidity and health care costs after cardiac surgery is uncertain .
METHODS	We conducted a multicenter , parallel-group trial in which patients older than 16 years of age who were undergoing nonemergency cardiac surgery were recruited from 17 centers in the United Kingdom .
METHODS	Patients with a postoperative hemoglobin level of less than 9 g per deciliter were randomly assigned to a restrictive transfusion threshold ( hemoglobin level < 7.5 g per deciliter ) or a liberal transfusion threshold ( hemoglobin level < 9 g per deciliter ) .
METHODS	The primary outcome was a serious infection ( sepsis or wound infection ) or an ischemic event ( permanent stroke [ confirmation on brain imaging and deficit in motor , sensory , or coordination functions ] , myocardial infarction , infarction of the gut , or acute kidney injury ) within 3 months after randomization .
METHODS	Health care costs , excluding the index surgery , were estimated from the day of surgery to 3 months after surgery .
RESULTS	A total of 2007 patients underwent randomization ; 4 participants withdrew , leaving 1000 in the restrictive-threshold group and 1003 in the liberal-threshold group .
RESULTS	Transfusion rates after randomization were 53.4 % and 92.2 % in the two groups , respectively .
RESULTS	The primary outcome occurred in 35.1 % of the patients in the restrictive-threshold group and 33.0 % of the patients in the liberal-threshold group ( odds ratio , 1.11 ; 95 % confidence interval [ CI ] , 0.91 to 1.34 ; P = 0.30 ) ; there was no indication of heterogeneity according to subgroup .
RESULTS	There were more deaths in the restrictive-threshold group than in the liberal-threshold group ( 4.2 % vs. 2.6 % ; hazard ratio , 1.64 ; 95 % CI , 1.00 to 2.67 ; P = 0.045 ) .
RESULTS	Serious postoperative complications , excluding primary-outcome events , occurred in 35.7 % of participants in the restrictive-threshold group and 34.2 % of participants in the liberal-threshold group .
RESULTS	Total costs did not differ significantly between the groups .
CONCLUSIONS	A restrictive transfusion threshold after cardiac surgery was not superior to a liberal threshold with respect to morbidity or health care costs .
CONCLUSIONS	( Funded by the National Institute for Health Research Health Technology Assessment program ; Current Controlled Trials number , ISRCTN70923932 . )

###26255520
OBJECTIVE	To compare the efficacy differences between acupuncture at Zhibian ( BL 54 ) through Shuidao ( ST 28 ) and regular acupuncture for polycystic ovary syndrome .
METHODS	One hundred and one patients , by using random digital table , were randomly divided into an observation group ( 49 cases ) and a control group ( 52 cases ) .
METHODS	Patients in the observation group were treated with acupuncture at Zhibian ( BL 54 ) through Shuidao ( ST 28 ) as main acupoints , and accompanied acupoints were selected according to syndrome differentiation .
METHODS	Elongated needles ( 175 mm in length ) were inserted at Zhibian ( BL 54 ) with an angle of 200 with sagittal plane .
METHODS	The insertion depth was 100-115 mm , reaching Shuidao ( ST 28 ) and making acupuncture sensation arrive at diseased location .
METHODS	Patients in the control group were treated at the same acupoints with regular acupuncture technique .
METHODS	The menstruation condition was ignored for patients in both groups .
METHODS	The treatment was given once a day , 15 times as one session , and 5 consecutive sessions were given .
METHODS	The basic temperature and level of sex hormone were observed before and after treatment in the two groups , and clinical efficacy was compared .
RESULTS	The cured rate was 65.3 % ( 32/49 ) and the effective rate was 91.8 % ( 45/49 ) in the observation group after treatment , which was significantly superior to 48.1 % ( 25/52 ) and 63.5 % ( 33/52 ) in the control group ( both P < 0.01 ) .
RESULTS	The number of patients with typical biphasic fever and patients with atypical biphasic fever in the observation group was higher , than that in the control group , but that of unidirectional temperature was less than that in the control group ( P < 0.05 ) .
RESULTS	After treatment , the follicle-stimulating hormone ( FSH ) , luteinizing hormone ( LH ) , LH/FSH , testos terone ( T ) were significantly reduced in the observation group ( P < 0.01 , P < 0.05 ) ; the LH and T were also apparently reduced in the control group ( P < .01 , P < 0.05 ) .
RESULTS	The reduction of FSH , LH , LH/FSH and T in the observation group after treatment was more significant than that in the control group ( P < 0.05 , P < 0.01 ) .
CONCLUSIONS	Acuouncture at Zhibian ( BL 54 ) through Shuidao ( ST 28 ) could significantly improve the basic temperature of patients with polycystic ovary syndrome , and regulate hormone level of reproductive endocrine , which is superior to regular acupuncture .

###24518774
OBJECTIVE	Prospective cohort studies support the hypothesis that statin drug users have a lower risk of aggressive prostate cancer .
OBJECTIVE	Whether statin drug use influences the risk of screen detected disease is less clear , possibly because of complex detection biases .
OBJECTIVE	Thus , we investigated this association in a setting in which men had low baseline serum prostate specific antigen concentration and were screened annually .
METHODS	We performed a cohort study of 9,457 men 55 years old or older at randomization to the placebo arm of PCPT ( Prostate Cancer Prevention Trial ) .
METHODS	The men reported new use of medications quarterly .
METHODS	We estimated the multivariable adjusted HR of prostate cancer ( 574 cases in 62,192 person-years ) for statin drug use and duration of use during the trial using Cox proportional hazards regression .
RESULTS	During 7 years of followup statin drug use during the trial was not associated with the risk of total prostate cancer ( HR 1.03 , 95 % CI 0.82-1 .30 ) , or lower grade ( HR 0.96 , 95 % CI 0.71-1 .29 ) or higher grade ( HR 1.27 , 95 % CI 0.85-1 .90 ) prostate cancer .
RESULTS	Duration of use during followup was also not associated with the risk of total , or lower or higher grade disease ( p trend = 0.7 , 0.5 and 0.2 , respectively ) .
CONCLUSIONS	These prospective results do not support the hypothesis that statin drugs protect against prostate cancer in the setting of regular prostate cancer screening .

###25065424
BACKGROUND	Use of sedative agents for difficult to manage children during dental procedures has been indicated for years , but neither the agent nor the route has been found to be ideal .
OBJECTIVE	The aim of the study was to evaluate and compare the efficacy and safety of oral dexmedetomidine ( D ) and ketamine ( K ) in producing moderate sedation among uncooperative pediatric dental patients .
METHODS	This prospective , triple-blind , randomized comparative study included 112 ASA grade I children of both sexes aged 3-10years , who satisfied all the inclusion criteria .
METHODS	They were randomly divided into four groups and ketamine 8mgkg ( -1 ) ( K ) or dexmedetomidine 3gkg ( -1 ) ( D1 ) , 4gkg ( -1 ) ( D2 ) and 5gkg ( -1 ) ( D3 ) were given orally .
METHODS	Similar dental procedures were performed in these patients , and effects of these drugs were assessed in terms of changes in vital signs , onset and duration of sedation , analgesia , and amnesia .
METHODS	Secondary outcomes such as level of sedation , behavior , adverse effects , and overall success were also measured .
RESULTS	The onset of sedation was significantly rapid with K and D3 as compared to D1 and D2 .
RESULTS	Recovery from sedation was fastest in group D1 .
RESULTS	Intra - and postoperative analgesia and anterograde amnesia were highest with K and least with D1 , while D3 produced analgesia comparable to K.
RESULTS	In K treated group , vomiting was observed in five patients and two patients exhibited emergence phenomenon .
RESULTS	Overall , highest success rate was observed in D3 group .
CONCLUSIONS	Given by oral route , the novel sedative dexmedetomidine provides dose-dependent effective analgo-sedation , comparable to ketamine , with less adverse effects .

###25554233
OBJECTIVE	This study compared effectiveness of an enhanced versus standard implementation strategy ( Replicating Effective Programs [ REP ] ) on site-level uptake of Re-Engage , a national program for veterans with serious mental illness .
METHODS	Mental health providers at 158 Veterans Affairs ( VA ) facilities were given REP-based manuals and training in Re-Engage , which involved identifying veterans who had not been seen in VA care for at least one year , documenting their clinical status , and coordinating further health care .
METHODS	After six months , facilities not responding to REP ( N = 88 ) were randomized to receive six months of facilitation ( enhanced REP ) or continued standard REP. Site-level uptake was defined as percentage of patients ( N = 1,531 ) with updated documentation or with whom contact was attempted .
RESULTS	Rate of Re-Engage uptake was greater for enhanced REP sites compared with standard REP sites ( 41 % versus 31 % , p = .01 ) .
RESULTS	Total REP facilitation time was 7.3 hours per site for six months .
CONCLUSIONS	Added facilitation improved short-term uptake of a national mental health program .

###25209956
BACKGROUND	Despite evidence that outcomes are highly valued when they are expected sooner rather than further into the future ( Ainslie , 1975 ) , limited research effort has been devoted to understanding the role of exercise outcome proximity .
BACKGROUND	The purpose of this study was to examine how temporal proximity to positive outcomes influences exercisers ' intrinsic motivation .
BACKGROUND	We expected that focusing people on temporally proximal exercise outcomes would increase intrinsic motivation , especially among low-frequency exercisers .
METHODS	This online experimental study was completed by 135 community exercisers ( Mage = 31.11 , SD = 10.29 ; 62 % female ) who reported an average of 4.86 exercise bouts per week ( SD = 2.12 ) .
METHODS	Participants were randomly assigned to a condition that primed temporally proximal positive exercise outcomes ( i.e. experienced during or directly following an exercise bout ) or temporally distal outcomes ( i.e. experienced after days , months , or years of regular exercise ) .
METHODS	Participants then reported perceptions of behavioral regulation in exercise .
RESULTS	As expected , the proximal exercise outcome condition elicited increased intrinsic regulation among those participants who exercised less frequently ( i.e. 1 SD below the mean ) .
CONCLUSIONS	This study reveals the importance of considering proximity as an important dimension of exercise outcomes-particularly when promoting intrinsic motivation among relatively infrequent exercisers .

###24382594
OBJECTIVE	This study was conducted to determine whether augmenting supported employment with cognitive remediation can improve vocational outcomes and whether augmentation is more important for participants with lower community functioning .
METHODS	In this secondary analysis of data from two related , single-blind , randomized controlled trials , 175 participants with schizophrenia or schizoaffective disorder received supported employment or supported employment plus cognitive remediation and were classified into higher or lower community functioning according to a median split of their quality-of-life scores at baseline .
METHODS	Participants received one year of active intervention and follow-up a year later .
METHODS	Primary outcome measures were competitive employment rates and total hours of work .
RESULTS	Employment rates over two years for participants with lower community functioning were significantly different for the two conditions ( supported employment = 20 % , plus cognitive remediation = 49 % , p < .005 ) , whereas participants with higher functioning showed equivalent rates of employment ( 62 % versus 54 % , ns ) .
RESULTS	Among lower-functioning participants , those who received cognitive remediation also worked significantly more hours over two years than those who received supported employment only , but higher-functioning participants worked similar amounts of hours in both conditions .
RESULTS	Improvements in cognitive functioning and intrinsic motivation were related to employment outcomes but only for the lower-functioning group in the supported employment plus cognitive remediation condition , suggesting possible mechanisms for the observed effects .
CONCLUSIONS	Augmenting supported employment with cognitive remediation may boost vocational outcomes for participants with lower community functioning but may not be necessary for those functioning better in their communities .

###24818336
BACKGROUND	Ulinastatin is reported to inhibit pro-inflammatory markers and also inhibits coagulation and fibrinolysis .
BACKGROUND	The drug is available in East Asia for the treatment of acute pancreatitis .
OBJECTIVE	To study the effect of addition of ulinastatin to standard care on mortality and morbidity in Indian subjects with acute pancreatitis .
METHODS	Randomized , double-blind , placebo-controlled , multi-centre trial across 15 centres in India .
METHODS	Subjects , aged 18 to 70 years , with acute pancreatitis and elevated serum C-reactive protein ( CRP ) levels , were eligible for enrolment .
METHODS	Acute pancreatitis was diagnosed if the patient had at least two of the following criteria : suggestive abdominal pain , serum amylase and/or lipase > 3 times upper limit of normal , and imaging findings of acute pancreatitis .
METHODS	Subjects were classified as having mild or severe acute pancreatitis on the basis of the APACHE II score ( < 8 mild , > or = 8 severe ) .
METHODS	Standard care was given to all subjects as per the treating physician 's protocol .
METHODS	Eligible subjects were randomized to receive intravenous infusion of 200,000 IU ulinastatin or placebo in 100 mL of 0.9 % saline given over one hour every 12 hours for 5 days .
RESULTS	Of 135 randomized subjects , 129 completed the study ( mild 62 , severe 67 ) .
RESULTS	Pancreatitis was due to alcohol intake in a majority ( 81 % ) of subjects .
RESULTS	Baseline characteristics were similar between the ulinastatin and placebo groups .
RESULTS	Efficacy was evaluated in subjects who had received at least 3 days ( 6 doses ) of ulinastatin/placebo .
RESULTS	One subject with severe pancreatitis in the ulinastatin group versus six in the placebo group died ( p = 0.048 ) .
RESULTS	New organ dysfunction developed in 5 ulinastatin vs 4 placebo group subjects ( p = 0.744 ) with mild pancreatitis and 12 ulinastatin vs 29 placebo group subjects ( p = 0.0026 ) with severe pancreatitis .
RESULTS	Adverse events were significantly lower in subjects with severe pancreatitis in the ulinastatin group as compared to the placebo group ( p = 0.00001 ) .
RESULTS	Reduction in serum CRP was not different between the groups .
RESULTS	Median hospitalization was shorter by one day in the ulinastatin group ; the difference was not significant .
RESULTS	There was no infusion-related adverse event .
CONCLUSIONS	Ulinastatin prevents new organ dysfunction and reduces mortality in subjects with severe pancreatitis .

###24886163
OBJECTIVE	To evaluate and compare the risks of secondary cancers from therapeutic doses received by patients with hepatocellular carcinoma ( HCC ) during intensity-modulated radiotherapy ( IMRT ) , volumetric arc therapy ( VMAT ) , and tomotherapy ( TOMO ) .
METHODS	Treatments for five patients with hepatocellular carcinoma ( HCC ) were planned using IMRT , VMAT , and TOMO .
METHODS	Based on the Biological Effects of Ionizing Radiation VII method , the excess relative risk ( ERR ) , excess absolute risk ( EAR ) , and lifetime attributable risk ( LAR ) were evaluated from therapeutic doses , which were measured using radiophotoluminescence glass dosimeters ( RPLGDs ) for each organ inside a humanoid phantom .
RESULTS	The average organ equivalent doses ( OEDs ) of 5 patients were measured as 0.23 , 1.18 , 0.91 , 0.95 , 0.97 , 0.24 , and 0.20 Gy for the thyroid , lung , stomach , liver , small intestine , prostate ( or ovary ) , and rectum , respectively .
RESULTS	From the OED measurements , LAR incidence were calculated as 83 , 46 , 22 , 30 , 2 and 6 per 10 ( 4 ) person for the lung , stomach , normal liver , small intestine , prostate ( or ovary ) , and rectum .
CONCLUSIONS	We estimated the secondary cancer risks at various organs for patients with HCC who received different treatment modalities .
CONCLUSIONS	We found that HCC treatment is associated with a high secondary cancer risk in the lung and stomach .

###24996258
BACKGROUND	Probiotics are beneficial bacteria that are able to colonize the host digestive system , increasing the natural flora and preventing colonization of pathogenic organisms and thus , securing optimal utility of the feed .
BACKGROUND	However , commercial probiotic often do not meet the expected standards and the viability of the efficacy of these strains remains questionable .
BACKGROUND	Another major issue has been highlighted in relation to the application of antibiotic resistant probiotics , the antibiotic resistant gene can be transferred between organisms .
BACKGROUND	Recently , postbiotic metabolites produced from microbes have been extensively studied as feed additive in order to substitute in-feed antibiotics .
RESULTS	No significant difference ( P > 0.05 ) was found among the treatment groups on overall feed intake , egg weight , egg mass and feed conversion efficiency .
RESULTS	COM456 had a significant reduction ( P < 0.05 ) in faecal pH compared to the other groups at 28 weeks of age onwards .
RESULTS	COM456 had significant higher ( P < 0.05 ) level of lactic acid bacteria counts from 30 weeks of age onwards , followed by COM246 and COM345 at 32 and 34 weeks of age , respectively .
RESULTS	Significant reduction of faecal Enterobacteriaceae ( P < 0.05 ) were observed in COM246 and COM456 from 30 weeks of age onwards .
RESULTS	The lowest levels ( P < 0.05 ) of plasma and egg yolk cholesterol were observed in COM456 , followed by COM345 and COM246 .
RESULTS	There was no significant difference in terms of yolk weight between the treatment groups .
RESULTS	Significant higher ( P < 0.05 ) content of C18 :3 , C20 :2 and C22 :6 were found in treatments supplemented with metabolite combinations as compared with the control group .
CONCLUSIONS	The present study demonstrated the positive effects of metabolite combinations supplementation in laying hens .
CONCLUSIONS	Increase in hen-day egg production was observed in all treatments supplemented with metabolite combinations .
CONCLUSIONS	In addition , the metabolite combinations , COM456 had reduced the faecal pH and faecal Enterobacteriaceae population , improved the faecal lactic acid bacteria , reduced the plasma and yolk cholesterol and improved the faecal volatile fatty acids content .
CONCLUSIONS	Postbiotic metabolite combinations can be used as an alternative feed additive to achieve high productivity and better animal health while reducing the use of conventional chemotherapeutic agents such as in-feed antimicrobials .

###24641712
OBJECTIVE	The aim of the study was to investigate whether impairments associated with cerebral palsy were stable between childhood and adolescence .
METHODS	The Study of Participation of Children with Cerebral Palsy Living in Europe ( SPARCLE ) longitudinal study was conducted in nine European regions .
METHODS	In total , 818 children aged 8 to 12 years were randomly selected from population-based registers ; 594 ( 73 % ) were followed up at the age of 13 to 17 years ( 344 males , 250 females ; median age 10 y 4 mo ) Research associates visited them in their homes and recorded their motor function and additional impairments .
METHODS	Stability of impairment was assessed using the weighted kappa coefficient .
RESULTS	The proportion of participants whose level of impairment remained unchanged varied from 63 % for fine motor function to 98 % for hearing .
RESULTS	For gross motor function , communication , and cognitive level , the kappa and the lower bound of its 95 % confidence interval ( CI ) were above 0.75 , indicating stability between childhood and adolescence ; for fine motor function and feeding , the kappa was above 0.75 but the lower bound of the 95 % CI was below 0.75 , indicating probable stability ; for seizures and vision , the kappa was below 0.75 , although the upper bound of the 95 % CI was above 0.75 , indicating possible change ; for hearing the kappa and its entire CI were below 0.75 , indicating change .
RESULTS	Overall , 81 % of participants had no seizures in childhood , of whom 93 % were seizure-free in adolescence .
CONCLUSIONS	Motor function and additional impairments were generally stable between childhood and adolescence .

###25286702
OBJECTIVE	To compare the clinical effects and safety between greenlight photoselective vaporization of prostate ( PVP ) and plasmakinetic resection of prostate ( PRP ) in eldly benign prostatic hyperplasia ( BPH ) men with high surgical risk .
OBJECTIVE	METHODS ; Fifty three eldly BPH patients , who had the indication of surgical treatment but complicated with at least one internal disease , were randomly divided into PVP group and PRP group .
OBJECTIVE	The clinical data of all the patients were collected and compared between the two groups , including pre-operative and post-operative international prostate symptom score ( IPSS ) , postvoid residual urine ( PVR ) , urine flow rate ( Qmax ) , quality of life ( QOL ) as well as prostate volume ( PV ) , operational time , operative bleeding volume , postoperative recovery , peri-operative complications .
RESULTS	The complete follow-up data of 44 patients were achieved : 21 of PVP , 23 of PRP .
RESULTS	There were significant differences between two groups in operative bleeding , bladder irrigation time , indwelling catheter time and hospital stay ( P < 0.002 ) .
RESULTS	The peri-operative bleeding was lower in PVP group , while the bladder irrigation time , indwelling catheter time and hospital stay were shorter in PVP group .
RESULTS	The operation time showed no difference ( P = 0.12 ) .
RESULTS	No significant differences were found 3 months postoperatively between two groups in all the data associated with urination ( IPSS , Qmax , PVR , QOL ) , P > 0.05 .
RESULTS	Complications ( urethrostenosis , retrograde ejaculationwere acceptable in both groups .
CONCLUSIONS	For surgical treatment of eldly men with high surgical risk , both PVP and PRP are safe and effective with the internal disease being sufficient control .

###25376604
OBJECTIVE	Walking speed is an important marker of functionality that is measured over courses of varying lengths , but it is unclear if course length affects measured pace .
METHODS	A total of 136 older adults completed two consecutive trials each of 3-m and 6-m walking courses , the order of which was randomly assigned .
METHODS	We calculated concordance correlation coefficients ( CCC ) and created Bland-Altman plots to evaluate the relationship between the two course distances .
RESULTS	Average walking speed was faster for the 6-m course and the second trial of each course .
RESULTS	There was high concordance between the first and second trials for both the 3-m and 6-m courses .
CONCLUSIONS	The 3 - and 6-m courses had excellent test-retest reliability and faster walking speed in later than earlier trials .
CONCLUSIONS	Higher concordance between courses for later trials suggests the utility of practice trials and adjusting for course length when combining walking speed measurements between different course lengths .

###24977250
OBJECTIVE	To compare the effectiveness of onlay bone blocks of equine origin ( test or XB group ) with autogenous bone blocks ( control or AB group ) harvested from the ramus or the iliac crest for the rehabilitation of partially or fully edentulous atrophic jaws with implant supported prostheses .
METHODS	Forty patients with partially or fully edentulous atrophic jaws having less than 5 mm of residual crestal bone height and/or less than 3 mm of bone thickness , as measured on computerised tomography ( CT ) scans , were randomised into two groups according to a parallel group design , either to be augmented with autogenous onlay bone blocks ( 20 patients ; AB group ) from the mandibular ramus or the iliac crest , or with onlays blocks of spongious bone of equine origin ( 20 patients ; XB group ) .
METHODS	Two centres treated 20 patients each .
METHODS	Six XB blocks were modelled on lithographic models of the jaws before grafting .
METHODS	The blocks were fixed with screws and osteosynthesis plates and were covered with resorbable barriers made of equine cortical bone and fixed with tacks .
METHODS	The autogenous bone grafts were left to heal for 4 months and the xenografts for 7 months before placing implants , which were submerged .
METHODS	After 4 months , either bar-retained overdentures or provisional reinforced acrylic prostheses were delivered .
METHODS	Provisional prostheses were replaced , after 4 months , by definitive fixed prostheses .
METHODS	Outcome measures were : prosthesis and implant failures ; complications ; patient satisfaction ; pain recorded 3 and 10 days post-augmentation ; number of days of hospitalisation , total and partial infirmity days .
METHODS	All patients were followed for 4 months after loading .
RESULTS	All patients could be rehabilitated with implant-supported prostheses and none dropped out .
RESULTS	Twenty-eight patients were augmented in the maxilla ( 15 with AB and 13 with XB ) and 12 in the mandible ( 5 with AB and 7 with XB ) .
RESULTS	No AB graft failed totally versus 10 XB grafts ( difference = 0.5 ; 95 % CI 0.23 to 0.68 ; P = 0.0004 ) .
RESULTS	In particular , all 7 XB mandibular grafts and 5 out of 6 XB blocks ( 3 in mandibles and 2 in maxillas ) , which were previously modelled on lithographic models of the jaws failed .
RESULTS	One implant failed in one AB patient versus 11 implants in 4 XB patients ( P = 0.3416 ) .
RESULTS	All but 1 prostheses were loaded in time in the AB patients , versus 4 prostheses which were loaded with delays in XB patients because of graft and implant failures ( P = 0.3416 ) .
RESULTS	Four complications occurred in 4 AB patients versus 15 complications in 12 XB patients ( difference = 0.4 ; 95 % CI 0.09 to 0.63 ; P = 0.0225 ) .
RESULTS	Fourteen AB patients reported moderate pain 3 days postoperatively versus 6 XB patients ( P = 0.0562 ) ; at 10 days , 10 AB patients reported moderate pain versus 1 XB patient ( difference = -0.45 ; 95 % CI -0.65 to -0.17 ; P = 0.0033 ) .
RESULTS	The 14 patients harvested from the iliac crest were hospitalised for an average of 3.1 nights , whereas 7 patients treated with XB were hospitalised on average for 1.4 nights ( P < 0.0001 ) .
RESULTS	The number of total and partial infirmity days was 126 for theAB group and 43 for the XB group , and 220 for the AB group and 93 for the XB group , respectively ( mean day difference = -4.15 ; 95 % CI -7.35 to -0.95 ; P = 0.0134 and mean day difference = -5.7 ; 95 % CI -10.01 to -1.39 ; P = 0.0116 , respectively ) .
RESULTS	Seventeen AB patients versus 19 XB patients were fully satisfied with function of their prostheses ( P = 0.6050 ) , 18 AB patients versus 12 XB patients were fully satisfied with aesthetics of their prostheses ( P = 0.0648 ) , and 5 and 3 patients , respectively would not undergo the same procedure again ( P = 0.6948 ) .
RESULTS	There were no differences between the outcomes of the two centres with exception of prosthesis failures and complications in the maxilla .
CONCLUSIONS	Autogenous onlay bone blocks are superior to equine onlay bone blocks , especially in mandibles , where all equine blocks failed , therefore we strongly discourage the use of onlay bone blocks of equine origin in mandibles .

###25446376
BACKGROUND	Since sorafenib has shown activity in different tumour types and gemcitabine regimens improved the outcome for biliary tract cancer ( BTC ) patients , we evaluated first-line gemcitabine plus sorafenib in a double-blind phase II study .
METHODS	102 unresectable or metastatic BTC patients with histologically proven adenocarcinoma of gallbladder or intrahepatic bile ducts , Eastern Cooperative Oncology Group ( ECOG ) 0-2 were randomised to gemcitabine ( 1000 mg/m2 once weekly , first 7-weeks +1 - week rest followed by once 3-weeks +1 - week rest ) plus sorafenib ( 400 mg twice daily ) or placebo .
METHODS	Treatment continued until progression or unacceptable toxicity .
METHODS	Tumour samples were prospectively stained for sorafenib targets and potential biomarkers .
METHODS	Serum samples ( first two cycles ) were measured for vascular endothelial growth factors ( VEGFs ) , vascular endothelial growth factor receptor 2 ( VEGFR-2 ) and stromal cell-derived factor 1 ( SDF1 ) by enzyme-linked immunosorbent assay ( ELISA ) .
RESULTS	Gemcitabine plus sorafenib was generally well tolerated .
RESULTS	Four and three patients achieved partial responses in the sorafenib and placebo groups , respectively .
RESULTS	There was no difference in the primary end-point , median progression-free survival ( PFS ) for gemcitabine plus sorafenib versus gemcitabine plus placebo ( 3.0 versus 4.9 months , P = 0.859 ) , and no difference for median overall survival ( OS ) ( 8.4 versus 11.2 months , P = 0.775 ) .
RESULTS	Patients with liver metastasis after resection of primary BTC survived longer with sorafenib ( P = 0.019 ) compared to placebo .
RESULTS	Patients who developed hand-foot syndrome ( HFS ) showed longer PFS and OS than patients without HFS .
RESULTS	Two sorafenib targets , VEGFR-2 and c-kit , were not expressed in BTC samples .
RESULTS	VEGFR-3 and Hif1 were associated with lymph node metastases and T stage .
RESULTS	Absence of PDGFR expression correlated with longer PFS .
CONCLUSIONS	The addition of sorafenib to gemcitabine did not demonstrate improved efficacy in advanced BTC patients .
CONCLUSIONS	Biomarker subgroup analysis suggested that some patients might benefit from combined treatment .

###24397061
BACKGROUND	Tennis elbow is a condition , characterised by pain and tenderness over the lateral epicondyle of the humerus , and pain on resisted dorsiflexion of the wrist , middle finger , or both .
BACKGROUND	The aim of this randomised controlled trial was to investigate the short term efficacy of local steroid injection compared with oral and topical NSAIDs .
METHODS	Sixty patients ( 45 male and 15 female ) were included in the study .
METHODS	The mean age was 42 years for men and 40 years for women .
METHODS	They were placed in group A and B ( 30 cases each ) .
METHODS	Group A received local steroid injection ( triamcinolone 20 mg mixed with lignocaine 2 % 1 cc ) and topical NSAID cream application ( diclofenac diethylammonium ) twice a day , tab .
METHODS	diclofenac sodium 50 mg twice a day for 3 weeks .
METHODS	Group B received tab diclofenac 50 mg twice a day and , topical NSAID cream application twice a day for 3 weeks .
METHODS	Assessment of patients was made 3 times ; first at the start of the study , 2nd time after 6 weeks , and 3rd time after 12 weeks .
METHODS	A blinded assessor rated the elbow complaints of the patients at resisted dorsiflexion of wrist using VAS ( 0 = no severity , 1-3 mild , 4-6 moderate , 7-9 sever , 10 = maximum severity ) .
RESULTS	At six weeks , 22 ( 73.33 % ) patient in group A had no pain as compared to 7 ( 23.33 % ) patients in group B who were pain free ( p < 0.0001 , chi2 = 38.75 ) .
RESULTS	At 12 weeks 27 ( 90 % ) patients in group A were pain free compared to group B in which 7 ( 23.33 % ) patients were pain free ( p < 0.0001 , chi2 = 27.56 ) .
CONCLUSIONS	In patients with tennis elbow , the use of local steroid injection in combination with topical and oral NSAIDs is superior to the use of combination of topical and oral NSAIDs .
CONCLUSIONS	Better results with combination therapy using local steroid injection may be limited to the short term .

###25099983
BACKGROUND	Few randomized controlled trial studies have focused on the effect of music in cancer patients , and there are no randomized controlled trials on the effects of live music with saxophone in cancer patients .
OBJECTIVE	To determine the effects of live saxophone music on various physiological parameters , pain level , and mood level .
METHODS	A randomized controlled trial study .
METHODS	52 cancer patients were randomized to a control group ( n = 26 ) , an experimental group ( n = 26 ) whose members received 30 minutes of live music therapy with saxophone .
METHODS	Systolic and diastolic blood pressure , pulse rate , glycemia , oxygen saturation , pain level , and mood level were measured before and after the live music performance .
RESULTS	There was a statistical difference between the groups for oxygen saturation ( 0.003 ) and mood level ( 0.001 ) .
CONCLUSIONS	Live music performed with a saxophone could be introduced in oncology care to improve the oxygen saturation and mood in cancer patients .

###24915210
BACKGROUND	Treatment of Staphylococcus aureus colonization before surgery reduces risk of surgical site infection ( SSI ) .
BACKGROUND	The regimen of nasal mupirocin ointment and topical chlorhexidine gluconate is effective , but cost and patient compliance may be a barrier .
BACKGROUND	Nasal povidone-iodine solution may provide an alternative to mupirocin .
METHODS	We conducted an investigator-initiated , open-label , randomized trial comparing SSI after arthroplasty or spine fusion in patients receiving topical chlorhexidine wipes in combination with either twice daily application of nasal mupirocin ointment during the 5 days before surgery or 2 applications of povidone-iodine solution into each nostril within 2 hours of surgical incision .
METHODS	The primary study end point was deep SSI within the 3 months after surgery .
RESULTS	In the modified intent-to-treat analysis , a deep SSI developed after 14 of 855 surgical procedures in the mupirocin group and 6 of 842 surgical procedures in the povidone-iodine group ( P = .1 ) ; S. aureus deep SSI developed after 5 surgical procedures in the mupirocin group and 1 surgical procedure in the povidone-iodine group ( P = .2 ) .
RESULTS	In the per protocol analysis , S. aureus deep SSI developed in 5 of 763 surgical procedures in the mupirocin group and 0 of 776 surgical procedures in the povidone-iodine group ( P = .03 ) .
CONCLUSIONS	Nasal povidone-iodine may be considered as an alternative to mupirocin in a multifaceted approach to reduce SSI .
BACKGROUND	ClinicalTrials.gov identifier : NCT01313182 .

###24694077
BACKGROUND	In a previously reported split-mouth , randomized controlled trial , Miller Class II gingival recession defects were treated with either a connective tissue graft ( CTG ) ( control ) or recombinant human platelet-derived growth factor-BB + - tricalcium phosphate ( test ) , both in combination with a coronally advanced flap ( CAF ) .
BACKGROUND	At 6 months , multiple outcome measures were examined .
BACKGROUND	The purpose of the current study is to examine the major efficacy parameters at 5 years .
METHODS	Twenty of the original 30 patients were available for follow-up 5 years after the original surgery .
METHODS	Outcomes examined were recession depth , probing depth , clinical attachment level ( CAL ) , height of keratinized tissue ( wKT ) , and percentage of root coverage .
METHODS	Within - and across-treatment group results at 6 months and 5 years were compared with original baseline values .
RESULTS	At 5 years , all quantitative parameters for both treatment protocols showed statistically significant improvements over baseline .
RESULTS	The primary outcome parameter , change in recession depth at 5 years , demonstrated statistically significant improvements in recession over baseline , although intergroup comparisons favored the control group at both 6 months and 5 years .
RESULTS	At 5 years , intergroup comparisons also favored the test group for percentage root coverage and change in wKT , whereas no statistically significant intergroup differences were seen for 100 % root coverage and changes to CAL .
CONCLUSIONS	In the present 5-year investigation , treatment with either test or control treatments for Miller Class II recession defects appear to lead to stable , clinically effective results , although CTG + CAF resulted in greater reductions in recession , greater percentage of root coverage , and increased wKT .

###25424601
OBJECTIVE	The objectives were to evaluate the effects of improvement of vitamin D status on biomarkers of oxidative stress ( OS ) in type 2 diabetic ( T2D ) subjects and whether vitamin D receptor ( VDR ) - FokI polymorphisms could modulate the response to vitamin D3 intake .
METHODS	Subjects with T2D were allocated to one of the two groups to receive either plain doogh ( PD ; containing 150mg calcium and no vitamin D/250ml , n1 = 50 ) or vitamin D3-fortified doogh ( FD ; containing 500IU/250ml , n1 = 50 ) twice a day for 12 weeks .
METHODS	Outcomes were changes in serum 25-hydroxyvitamin D ( 25 ( OH ) D ) , superoxide dismutase , glutathione ( GSH ) , total antioxidant capacity ( TAC ) and malondialdehyde ( MDA ) .
METHODS	VDR genotypes in 140 T2D subjects in FD were determined by FokI restriction enzyme .
RESULTS	After 12 weeks , serum 25 ( OH ) D increased significantly in FD ( from 38.5202.2 to 72.023.5 , P < 0.001 ) as compared with PD ( from 38.822.8 to 33.422.8 , P = 0.28 ) .
RESULTS	Comparisons between FD and PD revealed significant differences in changes of serum MDA ( -0.540.82 mol/l vs. +0.171 mol/l , P < 0.001 ) , GSH ( +8.440.1 ng/l vs -13.129.4 ng/l , P = 0.002 ) and TAC ( +0.140.43 mmol/l vs. +0.020.45 mmol/l bovine serum albumin equivalent , P = 0.03 ) .
RESULTS	Although there was no significant association between FokI genotypes and OS biomarkers , ff variant subgroup showed the weakest response to vitamin D.
CONCLUSIONS	Improvement of vitamin D status via daily intake of FD ameliorates OS biomarkers in T2D subjects and the interactive effect of FokI genotypes can not be ruled out .

###25475591
OBJECTIVE	This randomized controlled trial evaluated the effectiveness , feasibility , and acceptability of parent participation ( PP ) in an evidence-based method to reduce the pain of prekindergarten immunizations .
METHODS	Healthy children aged 4 to 6 years were randomized to a multimodal distraction method during administration of routine vaccines with PP and 1 medical assistant ( experimental group ) or 2 medical assistants ( standard-of-care comparison group ) .
METHODS	Children and parents rated the pain after injections , and a blinded observer coded children 's pain from videotapes .
RESULTS	In all , 76 children participated .
RESULTS	Despite group randomization , more children in the medical assistant-only group received a 3-injection series ( 25 ; 68 % ) than in the PP group ( 6 [ 15 % ] , P = .001 ) .
RESULTS	After adjustment for this imbalance , child-reported pain was higher in the PP group compared with the medical assistant-only group ( 2.95 vs 1.75 ; F = 5.87 ; df = 1.66 ; d = 0.64 ; P < .02 ) .
RESULTS	There were no differences between groups for parent-reported and observer-rated measures of pain or in intervention fidelity , duration of procedure , or child or parent satisfaction .
CONCLUSIONS	Although child-reported pain was higher for the PP group , the magnitude of the difference may not be clinically significant .
CONCLUSIONS	PP was feasible and acceptable to both parents and children , did not take any longer , and reduced the need for additional medical personnel .
CONCLUSIONS	Together , these data provide preliminary support for PP for prekindergarten immunization pain management .

###25524798
BACKGROUND	Palbociclib ( PD-0332991 ) is an oral , small-molecule inhibitor of cyclin-dependent kinases ( CDKs ) 4 and 6 with preclinical evidence of growth-inhibitory activity in oestrogen receptor-positive breast cancer cells and synergy with anti-oestrogens .
BACKGROUND	We aimed to assess the safety and efficacy of palbociclib in combination with letrozole as first-line treatment of patients with advanced , oestrogen receptor-positive , HER2-negative breast cancer .
METHODS	In this open-label , randomised phase 2 study , postmenopausal women with advanced oestrogen receptor-positive and HER2-negative breast cancer who had not received any systemic treatment for their advanced disease were eligible to participate .
METHODS	Patients were enrolled in two separate cohorts that accrued sequentially : in cohort 1 , patients were enrolled on the basis of their oestrogen receptor-positive and HER2-negative biomarker status alone , whereas in cohort 2 they were also required to have cancers with amplification of cyclin D1 ( CCND1 ) , loss of p16 ( INK4A or CDKN2A ) , or both .
METHODS	In both cohorts , patients were randomly assigned 1:1 via an interactive web-based randomisation system , stratified by disease site and disease-free interval , to receive continuous oral letrozole 2.5 mg daily or continuous oral letrozole 2.5 mg daily plus oral palbociclib 125 mg , given once daily for 3 weeks followed by 1 week off over 28-day cycles .
METHODS	The primary endpoint was investigator-assessed progression-free survival in the intention-to-treat population .
METHODS	Accrual to cohort 2 was stopped after an unplanned interim analysis of cohort 1 and the statistical analysis plan for the primary endpoint was amended to a combined analysis of cohorts 1 and 2 ( instead of cohort 2 alone ) .
METHODS	The study is ongoing but closed to accrual ; these are the results of the final analysis of progression-free survival .
METHODS	The study is registered with the ClinicalTrials.gov , number NCT00721409 .
RESULTS	Between Dec 22 , 2009 , and May 12 , 2012 , we randomly assigned 165 patients , 84 to palbociclib plus letrozole and 81 to letrozole alone .
RESULTS	At the time of the final analysis for progression-free survival ( median follow-up 29.6 months [ 95 % CI 27.9-36 .0 ] for the palbociclib plus letrozole group and 27.9 months [ 25.5-31 .1 ] for the letrozole group ) , 41 progression-free survival events had occurred in the palbociclib plus letrozole group and 59 in the letrozole group .
RESULTS	Median progression-free survival was 10.2 months ( 95 % CI 5.7-12 .6 ) for the letrozole group and 20.2 months ( 13.8-27 .5 ) for the palbociclib plus letrozole group ( HR 0.488 , 95 % CI 0.319-0 .748 ; one-sided p = 0.0004 ) .
RESULTS	In cohort 1 ( n = 66 ) , median progression-free survival was 5.7 months ( 2.6-10 .5 ) for the letrozole group and 26.1 months ( 11.2-not estimable ) for the palbociclib plus letrozole group ( HR 0.299 , 0.156-0 .572 ; one-sided p < 0.0001 ) ; in cohort 2 ( n = 99 ) , median progression-free survival was 11.1 months ( 7.1-16 .4 ) for the letrozole group and 18.1 months ( 13.1-27 .5 ) for the palbociclib plus letrozole group ( HR 0.508 , 0.303-0 .853 ; one-sided p = 0.0046 ) .
RESULTS	Grade 3-4 neutropenia was reported in 45 ( 54 % ) of 83 patients in the palbociclib plus letrozole group versus one ( 1 % ) of 77 patients in the letrozole group , leucopenia in 16 ( 19 % ) versus none , and fatigue in four ( 4 % ) versus one ( 1 % ) .
RESULTS	Serious adverse events that occurred in more than one patient in the palbociclib plus letrozole group were pulmonary embolism ( three [ 4 % ] patients ) , back pain ( two [ 2 % ] ) , and diarrhoea ( two [ 2 % ] ) .
RESULTS	No cases of febrile neutropenia or neutropenia-related infections were reported during the study .
RESULTS	11 ( 13 % ) patients in the palbociclib plus letrozole group and two ( 2 % ) in the letrozole group discontinued the study because of adverse events .
CONCLUSIONS	The addition of palbociclib to letrozole in this phase 2 study significantly improved progression-free survival in women with advanced oestrogen receptor-positive and HER2-negative breast cancer .
CONCLUSIONS	A phase 3 trial is currently underway .
BACKGROUND	Pfizer .

###24993838
BACKGROUND	Despite the findings of several randomized clinical studies , the role of gentamicin collagen implant ( GCI ) in rectal cancer surgery is unclear .
BACKGROUND	Local pelvic application of GCI following preoperative radiotherapy and total mesorectal excision ( TME ) was evaluated to determine the risk of surgical site infections ( SSI ) .
METHODS	In this single-center trial , 176 patients with rectal cancer after preoperative , short-term radiotherapy ( 5 5 Gy ) were randomized either to the study group in which GCI was used or in the control group without GCI .
METHODS	Prior to surgery and intraoperatively five patients were excluded from the study .
METHODS	The remaining 171 patients were analyzed ; 86 were in the study group and 85 in the control group .
RESULTS	There were no statistically significant differences in the overall rate of early postoperative complications between the study and control group : 25.6 and 34.1 % respectively ; p = 0.245 , relative risk ( RR ) 0.750 [ 95 % confidence interval ( CI ) 0.471-1 .195 ] .
RESULTS	The reoperation rate was similar in both groups : 12.8 versus 9.4 % ; p = 0.628 ; RR 1.359 ; ( 95 % CI 0.575-3 .212 ) .
RESULTS	The total rate of SSI and organ space SSI were 22.2 and 15.8 % without differences between the study and control group .
RESULTS	In patients without anastomotic leakage , the risk of organ space SSI was significantly reduced in patients who received GCI : 2.6 versus 13.0 % ; p = 0.018 .
CONCLUSIONS	Application of GCI in the pelvic cavity after short-term preoperative radiotherapy and TME may reduce the risk of organ space SSI but only in the absence of anastomotic leakage .

###24776045
OBJECTIVE	The angiographic and clinical efficacy of polymer-free sirolimus-eluting stents vs polymer-based paclitaxel-eluting stents remain a matter of debate .
OBJECTIVE	We sought to investigate angiographic and clinical measures of efficacy of polymer-free sirolimus-eluting stents vs polymer-based paclitaxel-eluting stents .
METHODS	Patient data from the randomized intracoronary stenting and angiographic restenosis-test equivalence between the 2 drug-eluting stents ( ISAR-TEST ) clinical trial and the LIPSIA Yukon clinical trial ( randomized comparison of a polymer-free sirolimus-eluting stent vs a polymer-based paclitaxel-eluting stent in patients with diabetes mellitus ) were pooled .
METHODS	The angiographic ( primary ) endpoint was in-stent late lumen loss at 6 months to 9 months .
METHODS	The clinical ( secondary ) endpoints were death or myocardial infarction , cardiac death or myocardial infarction , target lesion revascularization , and myocardial infarction .
RESULTS	A total of 686 patients ( polymer-free sirolimus-eluting stents , n = 345 vs polymer-based paclitaxel-eluting stents , n = 341 ) and 751 lesions ( polymer-free sirolimus-eluting stents , n = 383 vs polymer-based paclitaxel-eluting stents , n = 368 ) were included in the study .
RESULTS	Control angiography ( 606lesions , 80.6 % ) showed comparable in-stent late lumen loss for polymer-free sirolimus-eluting stents vs polymer-based paclitaxel-eluting stents ( 0.53 [ 0.59 ] mm vs 0.46 [ 0.57 ] mm ; P = .15 ) .
RESULTS	Median follow-up was 34.8 months .
RESULTS	Polymer-free sirolimus-eluting stents and polymer-based paclitaxel-eluting stents were associated with comparable risk of death or myocardial infarction ( relative risk = 1.17 ; 95 % confidence interval , 0.49-2 .80 ; P = .71 ) , cardiac death or myocardial infarction ( relative risk = 1.17 ; 95 % confidence interval , 0.72-1 .89 ; P = .50 ) , target lesion revascularization ( relative risk = 0.98 ; 95 % confidence interval , 0.65-1 .47 ; P = .93 ) , and myocardial infarction ( relative risk = 1.79 ; 95 % confidence interval , 0.85-3 .76 ; P = .12 ) .
CONCLUSIONS	In this pooled analysis , polymer-free sirolimus-eluting stents were comparable to polymer-based paclitaxel-eluting stents with respect to both angiographic and clinical efficacy .

###24633171
OBJECTIVE	To determine whether language and word choice can reduce patients ' perception of pain experienced during colposcopy with biopsies .
METHODS	Women reporting for colposcopy at an academic medical center were randomized to hear standard language or gentle , non-pain-based language during colposcopy with biopsy and/or endocervical curettage .
METHODS	Participants then rated their pain during the procedure on a 10-cm visual analog scale .
METHODS	The pain scores among the 2 groups were compared using a Student t test .
RESULTS	Both women hearing standard language and those hearing gentle language during colposcopy reported low pain during the procedure ( 3.1 and 2.9 , respectively ) , which was not significantly different between groups ( p = .80 ) .
CONCLUSIONS	Although gentle language has been shown to effectively reduce pain associated with other procedures , it did not reduce the pain associated with colposcopy and biopsies in this study .

###24308806
OBJECTIVE	Internet-based health behaviour interventions have variable effects on health-related outcomes .
OBJECTIVE	Effectiveness may be improved by optimizing the design of interventions .
OBJECTIVE	This study examined the specific effect on engagement of providing two different design features - tailoring and self-assessment .
METHODS	Three versions of an Internet-delivered intervention to support the self-care of mild bowel problems were developed that provided ( 1 ) self-assessment without tailored feedback , ( 2 ) self-assessment with tailored feedback , and ( 3 ) generic information only .
METHODS	A qualitative study explored participants ' engagement with each version of the intervention ( N = 24 ) .
METHODS	A larger quantitative study systematically compared participants ' use of the intervention and self-reported engagement using a partial factorial design ( n = 178 ) .
RESULTS	Findings from the qualitative study suggested that self-assessment without tailored feedback appeared to be less acceptable to participants because it was viewed as offering no personal benefit in the absence of personalized advice .
RESULTS	In the quantitative study , self-assessment without tailored feedback was associated with greater dropout than when provided in conjunction with tailored feedback .
RESULTS	There were significant group differences in participants ' engagement with the intervention and perceptions of the intervention .
RESULTS	Self-assessment without tailored feedback was rated as marginally less engaging and was associated with fewer positive perceptions than the generic information condition .
CONCLUSIONS	The acceptability of self-assessment or monitoring components may be optimized by also providing tailored feedback .
CONCLUSIONS	Without tailored feedback , these components do not appear to be any more engaging than generic information provision .
CONCLUSIONS	Statement of contribution What is already known on this subject ?
CONCLUSIONS	Digital interventions can be effective for improving a range of health outcomes and behaviours .
CONCLUSIONS	There is huge variation in the success of different interventions using different combinations of design features .
CONCLUSIONS	What does this study add ?
CONCLUSIONS	This study used a systematic experimental design to identify the effect on engagement of providing interactive intervention design features alone and in combination .
CONCLUSIONS	Intervention engagement was better when self-assessment was provided in conjunction with tailored feedback .

###26104503
BACKGROUND	C-reactive protein ( CRP ) during pregnancy has been associated with adverse maternal outcomes such as preeclampsia and gestational diabetes mellitus .
BACKGROUND	Randomized trials suggest that exercise programs may be associated with reductions in CRP in non-pregnant populations ; however , such studies have not been conducted among pregnant women .
BACKGROUND	The purpose of this study was to evaluate the impact of an individually-tailored motivationally-matched exercise intervention on CRP in pregnant women .
METHODS	The Behaviors Affecting Baby and You study was a randomized controlled trial of prenatal physical activity to prevent the development of gestational diabetes mellitus in women at increased risk .
METHODS	Women were randomized to either a 12-week exercise intervention ( n = 84 ) or a comparison health and wellness intervention ( n = 87 ) .
METHODS	High sensitivity CRP ( mg/dL ) was measured using a commercial immunoassay kit .
METHODS	Physical activity was measured using the Pregnancy Physical Activity Questionnaire .
METHODS	Mixed model analyses were used to evaluate the impact of the intervention on change in CRP using an intent-to-treat approach .
RESULTS	CRP decreased ( -0.09 mg/dL , 95 % CI : -0.25 , 0.07 ) from pre - to post-intervention in the exercise arm ( p = 0.14 ) and increased ( 0.08 mg/dL , 95 % CI : -0.07 , 0.24 ) ( p = 0.64 ) in the health and wellness arm ; however the between group difference was not statistically significant ( p = 0.14 ) .
RESULTS	Findings did not differ according to ethnic group or pre-pregnancy body mass index .
RESULTS	In a secondary analysis based on self-reported physical activity , women who decreased their time spent in sports/exercise experienced a mean increase in CRP ( 0.09 mg/dL , 95 % CI : -0.14 , 0.33 ) , whereas women who maintained or increased their sports / exercise experienced a mean decrease in CRP ( -0.08 mg/dL , 95 % CI : -0.23 , 0.08 ) ( p = 0.046 ) .
CONCLUSIONS	Findings from this randomized trial in an ethnically and socio-economically diverse population of pregnant women were consistent with a positive impact of the exercise intervention on CRP levels , but not of statistical significance .
BACKGROUND	ClinicalTrials.gov : NCT00728377 .
BACKGROUND	Registered 2 August 2008 .

###24872682
BACKGROUND	Mixed venous and arterial ulcers account for approximately 15 % -30 % of all venous leg ulcerations .
BACKGROUND	Several studies have shown that matrix metalloproteinases ( MMPs ) and neutrophil gelatinase-associated lipocalin ( NGAL ) play a central role in the pathophysiology of venous and arterial diseases .
BACKGROUND	Some studies have shown the efficacy of glycosaminoglycans , such as sulodexide ( SDX ) , in treating patients with leg ulcers .
BACKGROUND	The aim of this study was to evaluate clinical effects of SDX and its correlation with MMPs and NGAL expression in patients with mixed arterial and venous leg ulcers .
METHODS	Patients eligible for this study were of both sexes , older than 20 years , and with a clinical and instrumental diagnosis of mixed ulcer .
RESULTS	Fifty-three patients of both sexes were enrolled and divided into two groups by means of randomization tables .
RESULTS	Group A ( treated group ) comprised 18 females and ten males ( median age : 68.7 years ) treated with standard treatment ( compression therapy and surgery ) + SDX ( 600 lipoprotein lipase-releasing units/day intramuscularly ) for 15 days followed by SDX 250 lipase-releasing units every 12 hours day orally for 6 months as adjunctive treatment .
RESULTS	Group B ( control group ) comprised 17 females and eight males ( median age : 64.2 years ) treated with standard treatment only ( compression therapy and surgery ) .
RESULTS	The type of surgery was chosen according to anatomical level of vein incompetence : superficial venous open surgery and/or subfascial endoscopic perforating surgery .
RESULTS	In all enrolled patients , blood samples were collected in order to evaluate the plasma levels of MMPs and NGAL through enzyme-linked immunosorbent assay .
RESULTS	These results were compared to another control group ( Group C ) of healthy individuals .
RESULTS	Moreover , biopsies of ulcers were taken to evaluate the tissue expression of MMPs and NGAL through Western blot analysis .
RESULTS	Our results revealed that SDX treatment is able to reduce both plasma levels and tissue expression of MMPs improving the clinical conditions in patients with mixed ulcers .
CONCLUSIONS	Inhibition of MMPs could represent a possible therapeutic intervention to limit the progression of leg ulceration .
CONCLUSIONS	In particular , our findings demonstrate the efficacy of SDX in patients with mixed arterial and venous chronic ulcers of the lower limbs .

###26033499
BACKGROUND	The objective of this study was to determine the efficacy and safety of locoregional therapy ( LRT ) combined with arsenic trioxide ( As2 O3 ) treatment in primary hepatocellular carcinoma ( HCC ) patients .
METHODS	One hundred twenty-five primary HCC patients were recruited for a randomized controlled study .
METHODS	Patients were randomly divided into group A ( n = 61 ) and group B ( n = 64 ) .
METHODS	All patients received transarterial chemoembolization .
METHODS	Group A patients were given As2 O3 at 10 mg/d for 4 courses ( 21 days per course ) with a 2-week interval between courses .
METHODS	Survival times , therapeutic responses , extrahepatic metastases , and adverse events were recorded .
RESULTS	A better therapeutic response was found in group A patients , as shown by higher objective response rate ( ORR ) and clinical benefit rate ( CBR ) values in group A versus group B ( ORR , 81.96 % [ 95 % confidence interval ( CI ) , 72.32 % -91.62 % ] vs 59.37 % [ 95 % CI , 47.34 % -71.41 % ] , ( 2 ) = 7.650 , P < .05 ; CBR , 95.08 % [ 95 % CI , 89.66 % -100.00 % ] vs 81.25 % [ 95 % CI , 71.69 % -90.81 % ] , ( 2 ) = 5.659 , P < .05 ) .
RESULTS	There were fewer patients with extrahepatic metastases in group A versus group B ( group A , 6 cases or 9.84 % [ 95 % CI , 2.36 % -17.31 % ] ; group B , 12 cases or 18.75 % [ 95 % CI , 9.19 % -28.31 % ] ) .
RESULTS	The survival rate for group A patients was significantly higher than that for group B patients ( P < .05 ) .
RESULTS	No significant differences were found between the 2 groups in terms of hematology or digestive system , liver , or kidney dysfunction except for facial and limb edema .
CONCLUSIONS	LRT combined with As2 O3 treatment prevents extrahepatic metastasis and prolongs the survival time for primary HCC patients .

###24610312
BACKGROUND	St John 's wort ( SJW ; Hypericum perforatum ) induces CYP3A4 that is involved in the metabolism of the hepatitis C virus ( HCV ) protease inhibitor boceprevir .
BACKGROUND	Reduced boceprevir exposure and efficacy would contribute to therapeutic failure and increase the risk for resistance development .
BACKGROUND	Boceprevir is co-administered with interferon/ribavirin , and depression has been described frequently in patients undergoing HCV treatment .
BACKGROUND	Patients may purchase over-the-counter herbals to manage depression , and knowing the interaction between SJW and boceprevir is desirable .
METHODS	This Phase I , open-label , three-period , cross-over pharmacokinetic study enrolled healthy males and females who , following consent and screening procedures , were randomized to receive SJW on days 1-14 , SJW plus boceprevir ( SJW on days 22-35 and together on days 31-35 ) and boceprevir on days 52-56 , separated by 7 day washout periods , or the same treatment in the opposite order .
METHODS	Pharmacokinetic sampling was performed at the end of each phase .
RESULTS	Seventeen ( 11 female ) subjects completed the study and no serious adverse events were reported .
RESULTS	Geometric mean ratios ( GMRs ) and 90 % CIs for boceprevir ( with SJW versus alone ) AUC ( 0-8 ) , C ( max ) and C8 were 0.91 ( 0.87-0 .96 ) , 0.94 ( 0.82-1 .07 ) and 1.00 ( 0.79-1 .27 ) , respectively .
RESULTS	GMRs and 90 % CIs for hypericin , the active component of SJW , ( with boceprevir versus alone ) AUC ( 0-8 ) , C ( max ) and C ( 8 ) were 1.23 ( 1.10-1 .38 ) , 1.32 ( 1.16-1 .52 ) and 1.37 ( 1.19-1 .58 ) , respectively .
CONCLUSIONS	SJW did not have a clinically significant effect on boceprevir plasma concentrations ( or those of its metabolite ) , suggesting that SJW and boceprevir can be safely co-administered .

###25336121
BACKGROUND	A randomized controlled trial of a multicomponent dyadic intervention ( a translated and adapted version of an intervention that has been shown to be effective for people with dementia in the USA ) was performed .
BACKGROUND	The exercise and support intervention was intended to reduce depressive symptoms of people with dementia and their caregivers .
BACKGROUND	The purpose of this process evaluation is to create in-depth insight into the delivery of the intervention and the effect analysis , to prevent drawing inappropriate conclusions on the efficacy or effectiveness of the intervention , and to formulate recommendations for future studies on complex geriatric interventions .
METHODS	Qualitative and quantitative data were collected .
METHODS	The process evaluation was performed according to the model presented by Reelick and colleagues , which encompasses the following three process components : ( 1 ) success rate of recruitment and quality of the study population ; ( 2 ) the quality of execution of the complex intervention ; and ( 3 ) the process of acquisition of the data .
RESULTS	The study design met high research standards and the intervention was carefully delivered .
RESULTS	Evaluation of the study population quality revealed a profound recruitment process resulting in a reasonable sample size .
RESULTS	Attrition rate during follow-up was acceptable .
RESULTS	With regard to the evaluation of the intervention quality , most interviewed participants experienced benefits of the intervention .
RESULTS	Attendance at the home visits was high and attrition to homework was moderate .
RESULTS	Evaluation of the data acquisition showed the positive value of the use of a mixed design ; qualitative analysis of the intervention revealed outcomes not measured in the quantitative analysis .
CONCLUSIONS	The process evaluation revealed a carefully and soundly performed study .
CONCLUSIONS	The mixed design contributed to valuable insights .
CONCLUSIONS	However , there were some restrictions worth considering .
CONCLUSIONS	The intervention components may have a different feasibility by moderate attrition to homework and some negative experiences of participants , which may be an indication of too intensive an intervention for this frail population in this specific country .
CONCLUSIONS	As a result , the results of the statistical effect analysis should be interpreted with caution .
BACKGROUND	The study has been registered at the Netherlands National Trial Register : NTR1802 , registration date 6 May 2009 .

###24343853
BACKGROUND	E-learning is an efficient and cost-effective educational method .
OBJECTIVE	This study aimed at evaluating the feasibility of an educational e-learning intervention , focused on teaching geriatric pharmacology and notions of comprehensive geriatric assessment , to improve drug prescribing to hospitalized elderly patients .
METHODS	Eight geriatric and internal medicine wards were randomized to intervention ( e-learning educational program ) or control .
METHODS	Clinicians of the two groups had to complete a specific per group e-learning program in 30 days .
METHODS	Then , ten patients ( aged 75 years ) had to be consecutively enrolled collecting clinical data at hospital admission , discharge , and 3 months later .
METHODS	The quality of prescription was evaluated comparing the prevalence of potentially inappropriate medications through Beer 's criteria and of potential drug-drug interactions through a specific computerized database .
RESULTS	The study feasibility was confirmed by the high percentage ( 90 % ) of clinicians who completed the e-learning program , the recruitment , and follow-up of all planned patients .
RESULTS	The intervention was well accepted by all participating clinicians who judged positively ( a mean score of > 3 points on a scale of 5 points : 0 = useless ; 5 = most useful ) the specific contents , the methodology applied , the clinical relevance and utility of e-learning contents and tools for the evaluation of the appropriateness of drug prescribing .
CONCLUSIONS	The pilot study met all the requested goals .
CONCLUSIONS	The main study is currently ongoing and is planned to finish on July 2015 .

###25088067
BACKGROUND	The fixed combination of extrafine beclomethasone dipropionate and formoterol fumarate ( BDP/FF ) pMDI ( Foster ( ) ) is approved for treatment of adult asthmatic patients .
BACKGROUND	In order to provide an alternative drug delivery system for BDP/FF to physicians and patients , a dry powder inhaler ( NEXThaler ( ) ) has been developed , capable to deliver extrafine particles to the lungs and therefore improve the dosing of the drugs , especially in patients with poor hand-breath coordination .
OBJECTIVE	This trial was performed to compare efficacy and safety of extrafine BDP/FF NEXThaler ( ) with extrafine BDP/FF pMDI or non-extrafine BDP DPI alone in adult patients with controlled asthma .
METHODS	In this 8-week randomised , double-blind , parallel-group trial , patients were randomized to receive either extrafine BDP/FF NEXThaler ( ) 100/6g bid , extrafine BDP/FF 100/6g pMDI bid or non-extrafine BDP DPI 100g bid .
METHODS	The primary efficacy variable was change from baseline to the entire 8-week randomised treatment period in average pre-dose morning PEF .
RESULTS	The ITT population comprised 754 patients .
RESULTS	Extrafine BDP/FF NEXThaler ( ) was non-inferior ( pre-defined margin : -15 L/min ) relative to extrafine BDP/FF pMDI ( mean difference : -1.84 ; 95 % CI : -6.73 , 3.05 ) in terms of the primary efficacy variable , change from baseline in average pre-dose morning PEF .
RESULTS	Statistical superiority of both extrafine BDP/FF formulations over non-extrafine BDP DPI was demonstrated for the primary efficacy variable ( providing evidence of assays sensitivity of the trial ) , ACQ score and percentage of rescue medication use-free days .
RESULTS	No significant safety signals were observed .
CONCLUSIONS	NEXThaler ( ) is an effective and well-tolerated delivery device for treatment of patients with asthma who need a regular treatment .

###26299227
BACKGROUND	Despite initial in-hospital treatment of acute heart failure ( HF ) , some patients experience worsening HF ( WHF ) .
BACKGROUND	There are limited data about the outcomes and characteristics of patients who experience in-hospital WHF .
RESULTS	We assessed the characteristics and outcomes of patients with and without WHF in the ASCEND-HF trial .
RESULTS	Worsening HF was defined as at least 1 symptom or sign of new , persistent , or WHF requiring additional intravenous inotropic/vasodilator or mechanical therapy during index hospitalization .
RESULTS	We assessed the relationship between WHF and 30-day mortality , 30-day mortality or HF hospitalization , and 180-day mortality .
RESULTS	We also assessed whether there was a differential association between early ( days 1-3 ) vs late ( day 4 ) WHF and outcomes .
RESULTS	Of 7,141 patients with acute HF , 354 ( 5 % ) experienced WHF .
RESULTS	Patients with WHF were more often male and had a history of atrial fibrillation or diabetes , lower blood pressure , and higher creatinine .
RESULTS	After risk adjustment , WHF was associated with increased 30-day mortality ( odds ratio 13.37 , 95 % CI 9.85-18 .14 ) , 30-day mortality or HF rehospitalization ( odds ratio 6.78 , 95 % CI 5.25-8 .76 ) , and 180-day mortality ( hazard ratio 3.90 , 95 % CI 3.14-4 .86 ) ( all P values < .0001 ) .
RESULTS	There was no evidence of a difference in outcomes between early and late WHF ( all P values for comparison .2 ) .
CONCLUSIONS	Worsening HF during index hospitalization was associated with worse 30 - and 180-day outcomes .
CONCLUSIONS	Worsening HF may represent an important patient-centered outcome in acute HF and a focus of future treatments .

###24512477
BACKGROUND	Chronic insomnia is a major public health problem affecting approximately 10 % of adults .
BACKGROUND	Use of meditation and yoga to develop mindful awareness ( ` mindfulness training ' ) may be an effective approach to treat chronic insomnia , with sleep outcomes comparable to nightly use of prescription sedatives , but more durable and with minimal or no side effects .
BACKGROUND	The purpose of this study was to understand mindfulness training as experienced by patients with chronic insomnia , and suggest procedures that may be useful in optimizing sleep benefits .
METHODS	Adults ( N = 18 ) who completed an 8-week mindfulness-based stress reduction ( MBSR ) program as part of a randomized , controlled clinical trial to evaluate MBSR as a treatment for chronic insomnia were invited to participate in post-trial focus groups .
METHODS	Two groups were held .
METHODS	Participants ( n = 9 ) described how their sleep routine , thoughts and emotions were affected by MBSR and about utility ( or not ) of various mindfulness techniques .
METHODS	Groups were audio-recorded , transcribed and analyzed using content analysis .
RESULTS	Four themes were identified : the impact of mindfulness on sleep and motivation to adopt a healthy sleep lifestyle ; benefits of mindfulness on aspects of life beyond sleep ; challenges and successes in adopting mindfulness-based practices ; and the importance of group sharing and support .
RESULTS	Participants said they were not sleeping more , but sleeping better , waking more refreshed , feeling less distressed about insomnia , and better able to cope when it occurred .
RESULTS	Some participants experienced the course as a call to action , and for them , practicing meditation and following sleep hygiene guidelines became priorities .
RESULTS	Motivation to sustain behavioral changes was reinforced by feeling physically better and more emotionally stable , and seeing others in the MBSR class improve .
RESULTS	The body scan was identified as an effective tool to enable falling asleep faster .
RESULTS	Participants described needing to continue practicing mindfulness to maintain benefits .
CONCLUSIONS	First-person accounts are consistent with published trial results of positive impacts of MBSR on sleep measured by sleep diary , actigraphy , and self-report sleep scales .
CONCLUSIONS	Findings indicate that mindfulness training in a group format , combined with sleep hygiene education , is important for effective application of MBSR as a treatment for chronic insomnia .

###24516261
BACKGROUND	The long half-life of atorvastatin and fenofibrate makes them suitable for alternate day therapy .
BACKGROUND	Hence , we aimed to study the efficacy , safety , and cost-effectiveness of alternate day therapy with atorvastatin and fenofibrate combination in mixed dyslipidemia .
METHODS	Eligible patients with mixed dyslipidemia were randomly allotted into 2 equal parallel groups-alternate day therapy group ( group 1 ) and daily therapy group ( group 2 ) .
METHODS	Patients in groups 1 and 2 received fixed dose combination of atorvastatin 10 mg and fenofibrate 160 mg on alternate days and daily , respectively , for 12 weeks .
METHODS	Mean percentage change from baseline in triglycerides ( TGLs ) , non-high-density lipoprotein cholesterol ( non-HDL-C ) , HDL-C , low-density lipoprotein cholesterol ( LDL-C ) , total cholesterol ( TC ) , and TC-HDL ratio , incidence of adverse effects , and cost-effectiveness were compared in both the groups .
RESULTS	Among 110 patients randomized , 99 completed the study till 12 weeks treatment duration .
RESULTS	The TGLs , non-HDL-C , TC , and LDL-C decreased by 56.4 % , 49.7 % , 36.5 % , and 39.2 % , respectively , in alternate day therapy group and by 57.5 % , 51.2 % , 37.5 % , and 39.4 % , respectively , in daily therapy group .
RESULTS	The HDL-C levels increased by 20.1 % in alternate day therapy group compared to 21.8 % in daily therapy group .
RESULTS	No statistically significant difference was seen between both the groups in mean percentage change in lipid parameters from baseline to end of 12 weeks .
RESULTS	Incidence of adverse events was reasonably less in alternate day therapy group .
CONCLUSIONS	Alternate day therapy with atorvastatin-fenofibrate combination is an effective and safe alternative to daily therapy in mixed dyslipidemia .
CONCLUSIONS	Apart from significant cost savings , reasonable reduction in the incidence of adverse events is seen with alternate day regimen .
CONCLUSIONS	However , larger studies are needed to more reliably confirm our interesting but preliminary results .

###25194621
OBJECTIVE	Muscle atrophy and weakness impair activity of daily living ( ADL ) .
OBJECTIVE	We examined whether chair stand exercise can improve ADL of hemodialysis patients .
METHODS	A randomized controlled trial .
METHODS	A single center study .
METHODS	Outpatients on hemodialysis older than 60 years ( 61-79years ) .
METHODS	Twelve weeks of intervention with chair stand exercise , 3 sessions/week versus the control exercise ( stretch , 1 session/week ) .
METHODS	The primary outcome was the change in functional independence measure ( FIM ) score from baseline .
METHODS	The secondary outcomes were changes in thigh circumference , muscle strength of quadriceps , 6-minute walking distance , maximum duration of chair stand exercise , health-related quality of life , cognitive function serum albumin , and hemoglobin .
RESULTS	Among the 27 patients who were randomized , 17 completed the study .
RESULTS	The change in FIM from baseline was greater in the intervention group ( 1 [ 1-3 ] vs. 0 [ 0-0 ] , median ( minimum to maximum ) , P < .001 ) due to the significant improvement in the FIM subscales related to mobility ( bed/chair/wheel chair ) and locomotion ( stair ) .
RESULTS	Among the secondary outcomes , significant difference was noticed in the changes in thigh circumference and the physical component summary score of health-related quality of life by Medical Outcome Study 36-Item Short-Form Health Survey ( SF-36v2 ) .
CONCLUSIONS	Chair stand exercise improved ADL in the hemodialysis patients aged older than 60years .

###25649275
OBJECTIVE	To investigate suggestion-induced placebo effects in inflammatory skin reactions .
METHODS	A healthy sample of volunteers ( N = 48 ) attended two laboratory sessions .
METHODS	In each , a local short term inflammatory skin reaction was induced with histamine .
METHODS	Participants were told that one session was a control session and the other was a treatment session in which an antihistamine cream would be applied to the arm to reduce the size of the weal and the experience of itch .
METHODS	Inert aqueous cream was applied in both sessions .
METHODS	Participants were randomly allocated to undergo either the control or the treatment session first .
RESULTS	The placebo manipulation successfully reduced self-reported itch from the control to the placebo treatment session , but no placebo effect was demonstrated in weal size .
RESULTS	Order effects were observed such that only those who underwent control procedures first had a smaller weal in the placebo treatment session as compared to the control session .
RESULTS	The same order effect was seen for reported itch at one minute post histamine administration , but this disappeared at the three and five minute measures .
CONCLUSIONS	Findings suggest that explicit verbal suggestion can reduce the experience of itch .
CONCLUSIONS	In addition to conscious awareness , a concrete representation of the suggested changes gained from prior experience to the stimulus may be an important component of placebo effects on inflammatory skin reactions .

###25123092
BACKGROUND	Fast-track treatment in cardiac surgery has become the global standard of care .
BACKGROUND	We compared the efficacy and safety of a specialised post-anaesthetic care unit ( PACU ) to a conventional intensive care unit ( ICU ) in achieving defined fast-track end-points in adult patients after elective cardiac surgery .
METHODS	In a prospective , single blinded , randomized study , 200 adult patients undergoing elective cardiac surgery ( coronary artery bypass graft ( CABG ) , valve surgery or combined CABG and valve surgery ) , were selected to receive their postoperative treatment either in the ICU ( n = 100 ) , or in the PACU ( n = 100 ) .
METHODS	Patients who , at the time of surgery , were in cardiogenic shock , required renal dialysis , or had an additive EuroSCORE of more than 10 were excluded from the study .
METHODS	The primary end points were : time to extubation ( ET ) , and length of stay in the PACU or ICU ( PACU/ICU LOS respectively ) .
METHODS	Secondary end points analysed were the incidences of : surgical re-exploration , development of haemothorax , new onset cardiac arrhythmia , low cardiac output syndrome , need for cardio-pulmonary resuscitation , stroke , acute renal failure , and death .
RESULTS	Median time to extubation was 90 [ 50 ; 140 ] min in the PACU vs. 478 [ 305 ; 643 ] min in the ICU group ( P < 0.001 ) .
RESULTS	Median length of stay in PACU was 3.3 [ 2.7 ; 4.0 ] hours vs. 17.9 [ 10.3 ; 24.9 ] hours in the ICU ( P < 0.001 ) .
RESULTS	Of the adverse events examined , only the incidence of new onset cardiac arrhythmia ( 25 in PACU vs. 41 in ICU , P = 0.02 ) was statistically different between groups .
CONCLUSIONS	Treatment in a specialised PACU rather than an ICU , after elective cardiac surgery leads to earlier extubation and quicker discharge to a step down unit , without compromising patient safety .
BACKGROUND	ISRCTN71768341 .
BACKGROUND	Registered 11 March 2014 .

###25711328
OBJECTIVE	We describe neuropsychological test performance ( NP ) in antiretroviral treatment ( ART ) - nave HIV-positive individuals with CD4 cell counts above 500 cells/L .
METHODS	In a neurology substudy of the International Network for Strategic Initiatives in Global HIV Trials ( INSIGHT ) Strategic Timing of AntiRetroviral Treatment ( START ) study , eight neurocognitive tests were administered .
METHODS	The primary measure of NP was the quantitative NPz-score ( QNPZ-8 ) , the average of the z-scores for the eight tests .
METHODS	Associations of baseline factors with QNPZ-8 scores were assessed by multiple regression .
METHODS	Mild neurocognitive impairment ( NCI ) was defined as z-scores < -1 in at least two of six cognitive domains .
RESULTS	A total of 608 participants had a median age of 34 years ; 11 % were women and 15 % were black ; the median time since HIV diagnosis was 0.9 years ; the median CD4 cell count was 633 cells/L ; 19.9 % had mild NCI .
RESULTS	Better NP was independently associated with younger age , being white , higher body mass index ( 0.10 per 10kg/m ( 2 ) higher ) , and higher haematocrit percentage ( 0.19 per 10 % higher ) .
RESULTS	Worse NP was associated with longer time since HIV diagnosis ( -0.17 per 10 years ) , diabetes ( -0.29 ) and higher Framingham risk score ( -0.15 per 10 points higher ) .
RESULTS	QNPZ-8 scores differed significantly between geographical locations , with the lowest scores in Brazil and Argentina/Chile .
CONCLUSIONS	This is the largest study of NP in ART-nave HIV-positive adults with CD4 counts > 500 cells/L .
CONCLUSIONS	Demographic factors and diabetes were most strongly associated with NP .
CONCLUSIONS	Unmeasured educational/sociocultural factors may explain geographical differences .
CONCLUSIONS	Poorer NP was independently associated with longer time since HIV diagnosis , suggesting that untreated HIV infection might deleteriously affect NP , but the effect was small .

###24667749
OBJECTIVE	Sodium alginate reduces appetite and glycemia , when consumed in water - and sugar-based drinks .
OBJECTIVE	But , its effects when added to other commonly consumed beverages have not been reported .
OBJECTIVE	Because chocolate milk ( CM ) is criticized for raising blood glucose more than unflavored milk , the aim of our study was to investigate the effect of adding a strong-gelling sodium alginate to CM on glycemia , insulinemia , appetite and food intake .
METHODS	In a randomized crossover design , 24 men ( 22.90.4 years ; 22.50.3 kg/m ( 2 ) ) were provided with isovolumetric ( 325ml ) treatments of CM , 1.25 % alginate CM , 2.5 % alginate CM or 2.5 % alginate solution .
METHODS	Sodium alginate had a ratio of 0.78:1 of mannuronic acid ( M ) to guluronic acid ( G ) residues , and was block distributed .
METHODS	Treatments were standardized for lactose , sucrose and calcium content , and provided 120min before an ad libitum pizza meal during which food intake was measured .
METHODS	Appetite and blood glucose and insulin were measured at baseline and at intervals pre - and post-meal .
RESULTS	Addition of 2.5 % alginate to CM reduced peak glucose concentrations , at 30min , by an average of 6 % and 13 % compared with 1.25 % alginate CM ( 95 % confidence intervals ( CIs ) : 0.02-1 .08 ; P = 0.037 ) and CM alone ( 95 % CIs : 0.49-1 .55 ; P = 0.000 ) respectively .
RESULTS	Insulin peaks at 30min were lower by 46 % after 2.5 % alginate CM relative to CM ( 95 % CIs : 3.49-31 .78 ; P = 0.009 ) .
RESULTS	Pre-meal appetite was attenuated dose dependently by alginate addition to CM ; CM with 2.5 % alginate reduced mean appetite by an average of 134 % compared with CM alone ( 95 % CIs : 8.87-18 .98 ; P = 0.000 ) .
RESULTS	However , total caloric intake at the pizza meal did not differ among treatments .
CONCLUSIONS	The addition of a strong-gelling sodium alginate to CM decreases pre-meal glycemia , insulinemia and appetite , but not caloric intake at a meal 2h later , in healthy adult men .

###24267148
OBJECTIVE	It is not clear which is preferred between iron supplement and a dopamine agonist in the treatment of restless legs syndrome ( RLS ) with iron deficiency .
OBJECTIVE	The efficacies of oral iron supplementation and pramipexole for treatment of RLS with low-normal serum ferritin ( 15-50 ng/ml ) were compared .
METHODS	Thirty RLS patients who took either oral iron or pramipexole for 12 weeks and were followed at 2 , 4 , 8 and 12 weeks after treatment commencement were enrolled .
METHODS	Severities of RLS symptoms were assessed using the international RLS study group rating scale for severity ( IRLS ) at every visit .
METHODS	Treatment response was defined as a decrease in IRLS score of at least 50 % from baseline .
RESULTS	The 30 subjects were assigned equally to an iron or pramipexole group .
RESULTS	At baseline , IRLS scores and serum ferritin levels were similar between these two groups .
RESULTS	After 12 weeks , IRLS scores were lower than those at baseline in both groups ( iron -9.1 7.07 , P < 0.001 ; pramipexole -8.7 8.31 , P = 0.001 ) and similar between the two groups .
RESULTS	Changes in IRLS scores from baseline were similar between the two groups at each visit .
RESULTS	The response rates of the groups were identical at 46.7 % .
CONCLUSIONS	Pramipexole was not different from oral iron in terms of efficacy and improvement speed in RLS patients with a low-normal serum ferritin , but response rate of either oral iron or pramipexole alone was moderate .
CONCLUSIONS	Some proportion of RLS patients with iron deficiency might benefit from combined use of oral iron and dopamine agonists .

###25158943
BACKGROUND	To compare functional and anatomical outcomes after idiopathic macular pucker removal between eyes that underwent internal limiting membrane ( ILM ) peeling and eyes that did not .
METHODS	In this multicentric , randomized clinical trial , 60 eyes of 60 patients affected with idiopathic macular pucker were enrolled .
METHODS	Thirty eyes underwent 23-gauge pars plana vitrectomy associated with ILM peeling ( `` ILM peeling group '' ) , whereas 30 eyes did not undergo ILM peeling ( `` ILM not peeling group '' ) .
METHODS	Retinal sensitivity , frequency of microscotomas , and all the other microperimetric parameters were tested by MP1 microperimetry .
METHODS	Best-corrected visual acuity was investigated with the Early Treatment Diabetic Retinopathy Study chart .
METHODS	Anatomical outcomes were analyzed with spectral domain optical coherence tomography .
RESULTS	After a 12-month follow-up , the mean retinal sensitivity in the 4 central area showed a greater and faster recovery in the ILM not peeling group than in the ILM peeling group ( P = 0.041 ) .
RESULTS	The number of absolute microscotomas ( 0 dB ) within the 12 central retinal area was significantly higher in the ILM peeling group than in the ILM not peeling group ( P = 0.044 ) .
CONCLUSIONS	The ILM not peeling group seems to show better outcomes than the ILM peeling group as measured by mean retinal sensitivity and number of microscotomas after a 12-month follow-up .

###26054139
OBJECTIVE	To observe the clinical efficacy of BO 's abdominal acupuncture for obese type-2 diabetes mellitus ( T2DM ) .
METHODS	Sixty patients of obese T2DM were randomly divided into an acupuncture group and a medication group , 30 cases in each one .
METHODS	Patients in the medication group were treated with basic treatment combined with oral administration of regular antidiabetics , three weeks as one session .
METHODS	Patients in the acupuncture group , based on the medication group , were treated with abdominal acupuncture at Yinqiguiyuan [ Zhongwan ( CV 12 ) , Xiawan ( CV 10 ) , Qihai ( CV 6 ) , Guanguan ( CV 4 ) ] , Fusiguan [ Huaroumen ( ST 24 ) , Wailing ( TE 5 ) ] , Tianshu ( ST 25 ) , Daheng ( SP 15 ) , Qixue ( KI 13 ) , etc. ; the treatment was given three times per week , 3 weeks as one session .
METHODS	The systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , body weight , waist circumference ( WC ) , hip circumference , body mass index ( BI ) were observed before and after treatment in the two groups , and fasting plasma glucose ( FPG ) , fasting insulin ( FINS ) , 2-hours postprandial blood glucose by oral glucose tolerance test ( OGTT ) and insulin , total cholesterol ( TC ) , triglyceride ( TG ) , high-density lipoprotein cholesterol ( HDL-C ) and low-density lipoprotein cholesterol ( LDL-C ) , HOMA-IR of insulin resistance index were calculated and adverge events were recorded .
RESULTS	Compared before the treatment , SBP , WC , body weight , BMI , FPG , OG-TT2hBG , FINS , GTT2h insulin , HOMA-IR , TC and LDL-C in the acupuncture group were all significantly reduced ( all P < 0.05 ) , while FPG , OGTT2H insulin and TG were increased in the medication group ( all P < 0.05 ) ' .
RESULTS	The differences of reducing SBP , WC , FPG , OGTT2H insulin , HOMA-IR , TC , TG and LDL-C were statistically significant between the two groups ( all P < 0.05 ) .
RESULTS	The total effective rate was 93.3 % ( 28/30 ) in the acupuncture group , which was significantly superior to 23.3 % ( 7/30 ) in the medication group ( P < 0.01 ) .
CONCLUSIONS	BO 's abdominal acupuncture has obvious clinical efficacy for obese type-2 diabetes mellitus , featuring in lowering blood pressure , reducing weight , decreasing blood glucose , im - proving insulin resistance and lowering lipid , which has no adverse effects and is worthy of clinical popularization and application .

###24621836
OBJECTIVE	This study investigated whether inhibiting late Na ( + ) current by using ranolazine improved diastolic function in patients with heart failure with preserved ejection fraction ( HFpEF ) .
BACKGROUND	HFpEF accounts for > 50 % of all HF patients , but no specific treatment exists .
METHODS	The RALI-DHF ( RAnoLazIne for the Treatment of Diastolic Heart Failure ) study was a prospective , randomized , double-blind , placebo-controlled small proof-of-concept study .
METHODS	Inclusion criteria were EF45 % , a mitral E-wave velocity/mitral annular velocity ratio ( E/E ' ) > 15 or N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) concentration > 220 pg/ml , a left ventricular end-diastolic pressure ( LVEDP ) 18 mm Hg , and time-constant of relaxation ( tau ) 50 ms. Patients were randomized to ranolazine ( n = 12 ) or placebo ( n = 8 ) .
METHODS	Treatment consisted of intravenous infusion for 24 h , followed by oral treatment for 13 days .
RESULTS	After 30 min of infusion , LVEDP ( p = 0.04 ) and pulmonary capillary wedge pressure ( p = 0.04 ) decreased in the ranolazine group but not in the placebo group .
RESULTS	Mean pulmonary artery pressure showed a trend toward a decrease in the ranolazine group that was significant under pacing conditions at 120 beats/min ( p = 0.02 ) , but not for the placebo group .
RESULTS	These changes occurred without changes in left ventricular end-systolic pressure or systemic or pulmonary resistance but in the presence of a small but significant decrease in cardiac output ( p = 0.04 ) .
RESULTS	Relaxation parameters ( e.g. , tau , rate of decline of left ventricular pressure per minute [ dP/dtmin ] ) were unaltered .
RESULTS	Echocardiographically , the E/E ' ratio did not significantly change after 22 h.
RESULTS	After 14 days of treatment , no significant changes were observed in echocardiographic or cardiopulmonary exercise test parameters .
RESULTS	There were no significant effects on NT-pro-BNP levels .
CONCLUSIONS	Results of this proof-of-concept study revealed that ranolazine improved measures of hemodynamics but that there was no improvement in relaxation parameters .
CONCLUSIONS	( Ranolazine in Diastolic Heart Failure [ RALI-DHF ] ; NCT01163734 ) .

###24462581
BACKGROUND	Disulfiram may be efficacious for treating cocaine dependence or abuse , possibly through inhibiting dopamine - hydroxylase ( DH ) .
BACKGROUND	Consequently , this randomized , placebo-controlled clinical trial of disulfiram during buprenorphine maintenance treatment evaluated the study hypothesis that disulfiram is superior to placebo and explored whether disulfiram response is greatest for participants with a single nucleotide polymorphism coding for genetically low DH ( T-allele carriers ) .
METHODS	We randomized 177 buprenorphine-treated opioid dependent participants with cocaine dependence or abuse to 12 weeks of double-blind treatment with disulfiram 250mg daily ( n = 91 ) or placebo ( n = 86 ) .
METHODS	Of 155 participants genotyped , 84 were CC-homozygous , and 71 CT or TT genotypes .
METHODS	Primary outcomes included days per week cocaine use , number of cocaine-negative urine tests , and maximum consecutive weeks of cocaine abstinence .
METHODS	We analyzed an intention-to-treat comparison between disulfiram and placebo .
METHODS	We also explored potential pharmacogenetic interactions and examined treatment responses of four participant groups based on medication ( disulfiram or placebo ) by genotype ( CC-homozygous or T-allele carrier ) classification .
RESULTS	Disulfiram participants reported significantly less frequent cocaine use ; the differences in cocaine-negative urine tests or consecutive weeks abstinence were not significant .
RESULTS	Frequency of cocaine use was lowest in disulfiram-treated T-allele carriers ; differences in cocaine-negative urine tests or consecutive weeks abstinence were not significant among the four medication-genotype groups .
CONCLUSIONS	The findings provide limited support for the efficacy of disulfiram for reducing cocaine use and suggest that its mechanism of action may involve inhibition of DH .
CONCLUSIONS	Further studies of its efficacy , mechanism of action , and pharmacogenetics of response are warranted .

###24756139
OBJECTIVE	To quantitatively assess the predictive power of early variations of parotid gland volume and density on final changes at the end of therapy and , possibly , on acute xerostomia during IMRT for head-neck cancer .
METHODS	Data of 92 parotids ( 46 patients ) were available .
METHODS	Kinetics of the changes during treatment were described by the daily rate of density ( r ) and volume ( rvol ) variation based on weekly diagnostic kVCT images .
METHODS	Correlation between early and final changes was investigated as well as the correlation with prospective toxicity data ( CTCAEv3 .0 ) collected weekly during treatment for 24/46 patients .
RESULTS	A higher r was observed during the first compared to last week of treatment ( -0,50 vs -0,05 HU , p-value = 0.0001 ) .
RESULTS	Based on early variations , a good estimation of the final changes may be obtained ( : AUC = 0.82 , p = 0.0001 ; vol : AUC = 0.77 , p = 0.0001 ) .
RESULTS	Both early r and rvol predict a higher `` mean '' acute xerostomia score ( median value , 1.57 ; p-value = 0.01 ) .
RESULTS	Median early density rate changes for patients with mean xerostomia score / < 1.57 were -0.98 vs -0.22 HU/day respectively ( p = 0.05 ) .
CONCLUSIONS	Early density and volume variations accurately predict final changes of parotid glands .
CONCLUSIONS	A higher longitudinally assessed score of acute xerostomia is well predicted by higher r and rvol in the first two weeks of treatment : best cut-off values were -0.50 HU/day and -380 mm ( 3 ) / day for r and rvol respectively .
CONCLUSIONS	Further studies are necessary to definitively assess the potential of early density/volume changes in identifying more sensitive patients at higher risk of experiencing xerostomia .

###24458316
BACKGROUND	Young adult smokers have the highest smoking prevalence among all US age groups but are least likely to use evidence-based cessation counseling or medication to quit .
OBJECTIVE	Use and effectiveness of nicotine patch were explored in a randomized trial evaluating smoking cessation interventions with this population .
METHODS	Smokers aged 18 to 30 ( n = 3094 ) were recruited through online and off-line methods and from telephone quit lines and analyzed .
METHODS	Smokers were enrolled in a pretest-posttest trial , and randomized to 1 of 3 cessation services .
METHODS	Trial delivering counseling services by self-help booklet , telephone quit lines , or online expert system in the 48 continental United States .
METHODS	Smokers could request a free 2-week course of nicotine replacement therapy ( NRT ) patches from the project .
METHODS	Follow-up surveys at 12 and 26 weeks assessed smoking abstinence , use of NRT , counseling , and other cessation medications , and smoking-related variables .
RESULTS	Overall , 69.0 % of smokers reported using NRT ( M = 3.2 weeks ) at 12 weeks and 74.8 % ( M = 3.3 weeks ) at 26 weeks .
RESULTS	More smokers who were sent the free nicotine patches ( n = 1695 ; 54.8 % ) reported using NRT than those who did not receive them ( 12 weeks : 84.3 % vs 41.9 % , P < .001 ; 26 weeks : 87.6 % vs 51.1 % , P < .001 ) .
RESULTS	The use of NRT was associated with greater smoking abstinence at 12 weeks ( P < .001 ) and 26 weeks ( P < .05 ) , especially if used for more than 2 weeks ( P < .001 ) .
RESULTS	Smokers assigned to a self-help booklet or cessation Web site and heavier smokers were most likely to use NRT ( P < .05 ) , whereas those reporting marijuana use and binge drinking used NRT less ( P < .05 ) .
CONCLUSIONS	Many young adults were willing to try NRT , and it appeared to help them quit in the context of community-based cessation services .
CONCLUSIONS	Strategies should be developed to make NRT available to this age group and support them in using it to prevent lifelong smoking .

###24636027
OBJECTIVE	To determine the effect of povidone-iodine soaks on outcomes of hand infections after operative drainage .
METHODS	We performed a single-center , prospective , randomized trial to evaluate 100 consecutive hand infections .
METHODS	Forty-nine patients received povidone-iodine soaks 3 times daily , and 51patients received only daily dressing changes .
METHODS	Outcome measures were the number of operations , readmissions , reoperations for wound complications , and days spent in the hospital .
RESULTS	Patients treated with povidone soaks averaged 1.6 operations , and patients treated with daily dressing changes averaged 1.4 operations , a statistically insignificant difference .
RESULTS	The mean number of operations was also not different between groups for the dorsal hand or dorsal finger abscess subcategories .
RESULTS	No significant differences were found in length of stay , number of readmissions , or number of reoperations for wound complications .
CONCLUSIONS	Povidone-iodine soaks are not helpful in the postoperative management of hand infections
METHODS	Therapeutic II .

###24827456
OBJECTIVE	It has previously been shown that a combination of inhaled nitric oxide ( iNO ) and intravenous ( IV ) steroid attenuates endotoxin-induced organ damage in a 6-hour porcine endotoxemia model .
OBJECTIVE	We aimed to further explore these effects in a 30-hour model with attention to clinically important variables .
METHODS	Randomized controlled trial .
METHODS	University animal laboratory .
METHODS	Domestic piglets ( n = 30 ) .
METHODS	Animals were randomized into 5 groups ( n = 6 each ) : 1 ) Controls , 2 ) LPS-only ( endotoxin/lipopolysaccharide ( LPS ) infusion ) , 3 ) LPS + iNO , 4 ) LPS + IV steroid , 5 ) LPS + iNO + IV steroid .
RESULTS	Exposure to LPS temporarily increased pulmonary artery mean pressure and impeded renal function with elevated serum creatinine and acidosis compared to a control group over the 30-hour study period .
RESULTS	Double treatment with both iNO and IV steroid tended to blunt the deterioration in renal function , although the only significant effect was on Base Excess ( p = 0.045 ) .
RESULTS	None of the LPS + iNO + IV steroid treated animals died during the study period , whereas one animal died in each of the other LPS-infused groups .
CONCLUSIONS	This study suggests that combined early therapy with iNO and IV steroid is associated with partial protection of kidney function after 30 hours of experimental LPS infusion .

###25335248
OBJECTIVE	To observe the clinical efficacy difference between segmentation scraping and conventional acupuncture for cervical spondylosis ( CS ) so as to provide effective treatment method .
METHODS	Eighty-five cases of cervical type of CS were randomly divided into a scraping group ( 44 cases ) and an acupuncture group ( 41 cases ) .
METHODS	The segmentation scraping therapy was used in the scraping group .
METHODS	The scraping group was treated with focusing on scraping the head and joint part of neck and occiput in the upper cervical spine injury , and focusing on scraping the lower section of cervical and shoulder in the lower cervical spine injury , once every seven days , totally for 3 times .
METHODS	In the acupuncture group , Fengchi ( GB 20 ) , Wangu ( TE 5 ) , Tianzhu ( BL 10 ) , Neck-Jiaji ( EX-B 2 ) , etc. were selected , once daily , for 15 days .
METHODS	The visual analogue scale ( VAS ) was used to evaluate the immediate analgesic effect after the first treatment and the clinical efficacy was observed after the end of treatment .
RESULTS	After the first treatment , the score of VAS was decreased significantly in the scaping group ( P < 0.01 ) , but there was no significant difference in the acupuncture group compared with those before treatment ( P > 0.05 ) ; the score of VAS in the scaping group after the first treatment was lower than that in the acupuncture group ( 3.66 + / - 0.74 vs 5.43 + / - 0.35 , P < 0.01 ) .
RESULTS	Compared with before treatment , the scores of VAS were decreased significantly after treatment in two groups ( both P < 0.01 ) , but without significant difference between two groups ( P > 0.05 ) ; the effective rate was 95.5 % ( 42/44 ) in the scaping group and 87.8 % ( 36/41 ) in the acupuncture group , the curative effects were similar ( P > 0.05 ) .
CONCLUSIONS	Both of scraping and acupuncture therapies have good analgesic effect for cervical spondylosis , and overall effects are similar , but the immediate analgesic effect of scraping thrapy is better than that of conventional acupuncture .

###24934783
OBJECTIVE	Obesity is associated with poor outcomes in women with operable breast cancer .
OBJECTIVE	Lifestyle interventions ( LIs ) that help women reduce their weight may improve outcomes .
METHODS	We conducted a multicenter randomized trial comparing mail-based delivery of general health information alone or combined with a 24-month standardized , telephone-based LI that included diet ( 500 to 1,000 kcal per day deficit ) and physical activity ( 150 to 200 minutes of moderate-intensity physical activity per week ) goals to achieve weight loss ( up to 10 % ) .
METHODS	Women receiving adjuvant letrozole for T1-3N0-3M0 breast cancer with a body mass index ( BMI ) 24 kg/m ( 2 ) were eligible .
METHODS	Weight was measured in the clinic , and self-report physical activity , quality-of-life ( QOL ) , and diet questionnaires were completed .
METHODS	The primary outcome was disease-free survival .
METHODS	Accrual was terminated at 338 of 2,150 planned patients because of loss of funding .
RESULTS	Mean weight loss was significantly ( P < .001 ) greater in the LI arm versus the comparison arm ( 4.3 v 0.6 kg or 5.3 % v 0.7 % at 6 months and 3.1 v 0.3 kg or 3.6 % v 0.4 % at 24 months ) and occurred consistently across strata ( BMI 24 to < 30 v 30 kg/m ( 2 ) ; prior v no prior adjuvant chemotherapy ) .
RESULTS	Weight loss was greatest in those with higher baseline levels of moderate-intensity physical activity or improvement in QOL .
RESULTS	Hospitalization rates and medical events were similar .
CONCLUSIONS	A telephone-based LI led to significant weight loss that was still evident at 24 months , without adverse effects on QOL , hospitalizations , or medical events .
CONCLUSIONS	Adequately powered randomized trials with cancer end points are needed .

###25226850
BACKGROUND	Eosinophilic esophagitis ( EoE ) is a chronic allergic disease with limited treatment options .
OBJECTIVE	We evaluated QAX576 , an mAb against IL-13 , in the treatment of patients with EoE .
METHODS	Patients ( 18-50 years ) with proton pump inhibitor-resistant esophageal eosinophilia received intravenous QAX576 ( 6 mg/kg ) or placebo ( 2:1 ) at weeks 0 , 4 , and 8 and were followed for 6 months .
METHODS	The primary end point was the responder rate for a greater than 75 % decrease in peak eosinophil counts at week 12 .
METHODS	Efficacy was to be declared if the lower 90 % confidence limit for the proportion of responders on QAX576 was 35 % or greater .
METHODS	Secondary end points included changes in esophageal eosinophil counts , symptoms assessed by questionnaire scores , and quantification of a series of biomarkers .
RESULTS	Twenty-three patients completed the study up to week 12 , and 18 continued to the end of the study .
RESULTS	For the proximal and distal esophageal biopsies combined , the responder rate was 12.5 % ( 90 % confidence limit , 1 % to 43 % ) with placebo , compared to 40.0 % ( 90 % confidence limit , 22 % to 61 % ) with QAX576 .
RESULTS	Although the primary end point was not met , the mean esophageal eosinophil count decreased by 60 % with QAX576 versus an increase of 23 % with placebo ( P = .004 ) , and the decrease was sustained up to 6 months .
RESULTS	There was a trend for improved symptoms , particularly dysphagia .
RESULTS	QAX576 improved expression of EoE-relevant esophageal transcripts , including eotaxin-3 , periostin , and markers of mast cells and barrier function , for up to 6 months after treatment .
RESULTS	QAX576 was well tolerated .
CONCLUSIONS	QAX576 significantly improved intraepithelial esophageal eosinophil counts and dysregulated esophageal disease-related transcripts in adults with EoE in a sustained manner .

###24528942
BACKGROUND	Gastro esophageal reflux ( GER ) is common in cystic fibrosis ( CF ) and may contribute to lung disease .
BACKGROUND	Approximately 50 % of patients with cystic fibrosis are being treated with proton pump inhibitors ( PPIs ) .
METHODS	In a randomized controlled study in adults , we compared treatment with esomeprazole 40 mg twice daily versus placebo in patients with CF and frequent respiratory exacerbations over a thirty-six week treatment period to determine effect on time to first exacerbation and other health related outcomes .
RESULTS	17 patients without symptoms of GER were randomized and 15 completed the study .
RESULTS	13 subjects underwent 24 hour ambulatory pH probe monitoring ; 62 % had pH probe evidence of GER .
RESULTS	Forty one percent of subjects had a pulmonary exacerbation during the study .
RESULTS	There was no significant difference in time to first pulmonary exacerbation ( log rank test p = 0.3169 ) .
RESULTS	Five of nine subjects in the esomeprazole group compared with 2 of eight subjects in the placebo group experienced exacerbations ( esomeprazole vs. placebo : odds ratio = 3.455 , 95 % CI = ( 0.337 , 54.294 ) , Fisher 's exact test : p = 0.334 ) .
RESULTS	There was no change in Forced Expiratory Volume in one second , Gastroesophageal Symptom Assessment Score or CF Quality of Life score between the two treatment groups .
CONCLUSIONS	There was a trend to earlier exacerbation and more frequent exacerbations in subjects randomized to esomeprazole compared with placebo .
CONCLUSIONS	The effect of proton pump inhibitors on pulmonary exacerbations in CF warrants further investigation .
BACKGROUND	Clinicaltrials.gov , NCT01983774 .

###24848627
OBJECTIVE	The purpose of the current study was to determine whether increased physical activity ( PA ) altered glycemic control while ingesting an energy-balanced high-fructose diet .
METHODS	Twenty-two normal-weight men and women ( age : 21.20.6 years ; body mass index : 22.6 0.6 kg/m ( 2 ) ) participated in a randomized , cross-over design study in which they ingested an additional 75 g of fructose for 14 days while either maintaining low PA ( FR + inactive ) ( < 4500 steps/day ) or high PA ( FR + active ) ( > 12,000 steps/day ) .
METHODS	Before and following the 2-week loading period , a fructose-rich meal challenge was administered and blood was sampled at baseline and for 6 h after the meal and analyzed for glucagon-like peptide-1 ( GLP-1 ) , glucose-dependent insulinotropic peptide ( GIP ) , c-peptide , glucose and insulin concentrations .
RESULTS	Plasma insulin , glucose , c-peptide , GIP and GLP-1 concentrations significantly increased in response to the test meal on all test visits ( P < 0.05 ) .
RESULTS	C-peptide incremental area under the curve ( AUC ) decreased by 10,208 120 pmol/l min for 6 h from pre to post Fr + active intervention ( P = 0.02 ) leading to a decrease in plasma insulin total AUC ( pre : 58,470.26261.0 pmol/l ; post : 49,444.33883.0 pmol/l ; P = 0.04 ) resulting in a decrease peak [ Insulin ] ( P = 0.009 ) .
RESULTS	Following the FR + active intervention , GIP total AUC significantly decreased ( P = 0.005 ) yet only males had a lower total GLP-1 AUC after both interventions ( P = 0.049 ) .
RESULTS	There were no sex differences in GIP levels .
CONCLUSIONS	Increased PA attenuates the deleterious effects on glycemic control caused by a high-fructose diet .
CONCLUSIONS	These changes in glycemic control with PA are associated with decreases in insulin and GIP concentrations .

###25063992
OBJECTIVE	To evaluate the effectiveness of different brief intervention strategies at reducing hazardous or harmful drinking in the probation setting .
OBJECTIVE	Offender managers were randomized to three interventions , each of which built on the previous one : feedback on screening outcome and a client information leaflet control group , 5 min of structured brief advice and 20 min of brief lifestyle counselling .
METHODS	A pragmatic multicentre factorial cluster randomized controlled trial .
METHODS	The primary outcome was self-reported hazardous or harmful drinking status measured by Alcohol Use Disorders Identification Test ( AUDIT ) at 6 months ( negative status was a score of < 8 ) .
METHODS	Secondary outcomes were AUDIT status at 12 months , experience of alcohol-related problems , health utility , service utilization , readiness to change and reduction in conviction rates .
RESULTS	Follow-up rates were 68 % at 6 months and 60 % at 12 months .
RESULTS	At both time points , there was no significant advantage of more intensive interventions compared with the control group in terms of AUDIT status .
RESULTS	Those in the brief advice and brief lifestyle counselling intervention groups were statistically significantly less likely to reoffend ( 36 and 38 % , respectively ) than those in the client information leaflet group ( 50 % ) in the year following intervention .
CONCLUSIONS	Brief advice or brief lifestyle counselling provided no additional benefit in reducing hazardous or harmful drinking compared with feedback on screening outcome and a client information leaflet .
CONCLUSIONS	The impact of more intensive brief intervention on reoffending warrants further research .

###24976416
OBJECTIVE	The association of dairy food consumption with the risk for developing cardiovascular disease ( CVD ) has been investigated in many studies , but results often have been contradictory .
OBJECTIVE	The aim of the present study was to determine whether genetic polymorphisms are associated with interindividual variation in the response of CVD risk biomarker values after milk consumption .
METHODS	Fourteen single nucleotide polymorphisms ( SNPs ) in nine genes related to lipid metabolism were examined in 161 volunteers randomly allocated to consume either 500 mL/d of skimmed ( S ) or semi-skimmed ( SS ) milk for 1 year in addition to their usual diets .
METHODS	Total cholesterol/high-density lipoprotein cholesterol ( TC/HDL-C ) and low-density lipoprotein/HDL-C ratios were used as biomarkers of CVD risk .
METHODS	Three-way repeated-measures analysis of variance was used to examine the effect of time , treatment ( S or SS ) , and genotype on these biomarkers .
RESULTS	A TT genotype for the proliferator-activated receptor alpha polymorphism ( PPARA rs135549 SNP ) was significantly associated with a reduction in the TC/HDL and LDL/HDL ratios after 12 mo of S milk intake ( mean reduction -0.29 , 95 % confidence interval [ CI ] , -0.63 to 0.05 ; P = 0.0015 and -0.31 , 95 % CI , -0.58 to -0.03 ; P = 0.0005 , respectively ) .
RESULTS	However , no differences were observed after consuming either S or SS milk in the C allele carriers .
CONCLUSIONS	Saturated fatty acid consumption has long been linked to an increased risk for CVD ; indeed , the consumption of saturated fat-free products is recommended as a means of reducing this risk .
CONCLUSIONS	However , the present results suggest that many individuals might not benefit from such general recommendations .
CONCLUSIONS	Genetic analysis of PPARA rs135549 might help identify those individuals who are more likely to benefit from reducing the saturated fatty acid content of their diet .

###24625805
BACKGROUND	A significant waning of enterovirus 71 ( EV71 ) antibody titer after priming immunization with an inactivated EV71 vaccine implied the potential need for a booster dose .
METHODS	In this randomized , double-blind , placebo-controlled clinical trial , we recruited participants who had received at least 1 dose of priming EV71 vaccine in an early phase 2 clinical trial that was conducted in healthy infants and children aged 6-35 months .
METHODS	All participants were grouped according to the priming EV71 vaccine formulations ( 160U , 320U , and 640U with adjuvant and 640 U without adjuvant ) and then randomly assigned ( ratio , 2:1 ) to receive a booster dose of vaccine or placebo within each formulation group .
METHODS	The primary end point was the geometric mean titer 28 days after the booster dose .
RESULTS	A total of 773 participants were enrolled .
RESULTS	Significantly greater immunological responses were induced by the booster shot of all 4 formulations of EV71 vaccine , compared with that induced by placebo ( P < .0001 ) .
RESULTS	The frequencies of adverse reactions were similar between vaccine and placebo groups within each formulation group .
CONCLUSIONS	A booster dose of EV71 vaccine 1 year after the priming EV71 immunization shows excellent immunogenicity and good safety profile .
CONCLUSIONS	Clinical Trials Registration : NCT01734408 .

###25192882
OBJECTIVE	The aim of the study was to estimate the cost-effectiveness of a weight management programme including elements of physical exercise and dietary restriction which are designed to help women lose excess weight gained during pregnancy in the vulnerable postnatal period and inhibit the development of behaviours which could lead to future excess weight gain and obesity .
METHODS	A mathematical model based on a regression equation predicting change in weight over a fifteen year postnatal period was developed .
METHODS	The model included programme effectiveness and resource data based on a randomized controlled trial of a weight management programme implemented in a postnatal population in the United States .
METHODS	Utility and mortality data based on body mass index categories were also included .
METHODS	The model adopted a National Health Service ( NHS ) and personal social services ( PSS ) perspective , a lifetime time horizon and estimated the cost effectiveness of a weight management programme against a no change comparator in terms of an incremental cost-effectiveness ratio ( ICER ) .
RESULTS	The baseline results show that the difference in weight between women who received the weight management programme and women who received the control intervention was 3.02 kg at six months and 3.53 kg at fifteen years following childbirth .
RESULTS	This results in an ICER of 7355 per quality adjusted life year ( QALY ) for women who were married at childbirth .
CONCLUSIONS	The estimated ICER would suggest that such a weight management programme is cost-effective at a NICE threshold of 20,000 per QALY .
CONCLUSIONS	However significant structural and evidence based uncertainty is present in the analysis .

###25280810
BACKGROUND	Postnatal mental health problems , which are an international public health priority , are a suitable target for preventive approaches .
BACKGROUND	The financial burden of these disorders is borne across sectors in society , including health , early childhood , education , justice and the workforce .
BACKGROUND	This paper describes the planned economic evaluation of What Were We Thinking , a psychoeducational intervention for the prevention of postnatal mental health problems in first-time mothers .
METHODS	The evaluation will be conducted alongside a cluster-randomised controlled trial of its clinical effectiveness .
METHODS	Cost-effectiveness and costs-utility analyses will be conducted , resulting in estimates of cost per percentage point reduction in combined 30-day prevalence of depression , anxiety and adjustment disorders and cost per quality-adjusted life year gained .
METHODS	Uncertainty surrounding these estimates will be addressed using non-parametric bootstrapping and represented using cost-effectiveness acceptability curves .
METHODS	Additional cost analyses relevant for implementation will also be conducted .
METHODS	Modelling will be employed to estimate longer term cost-effectiveness if the intervention is found to be clinically effective during the period of the trial .
BACKGROUND	Approval to conduct the study was granted by the Southern Health ( now Monash Health ) Human Research Ethics Committee ( 24 April 2013 ; 11388B ) .
BACKGROUND	The study was registered with the Monash University Human Research Ethics Committee ( 30 April 2013 ; CF12/1022 -2012000474 ) .
BACKGROUND	The Education and Policy Research Committee , Victorian Government Department of Education and Early Childhood Development approved the study ( 22 March 2012 ; 2012_001472 ) .
BACKGROUND	Use of the EuroQol was registered with the EuroQol Group ; 16 August 2012 .
BACKGROUND	The trial was registered with the Australian New Zealand Clinical Trials Registry on 7 May 2012 ( registration number ACTRN12613000506796 ) .

###25066942
OBJECTIVE	To examine the effects of `` Rusie Dutton '' on health and quality of life in menopausal women .
METHODS	Menopausal women ( aged 45-59 ) were recruited and randomly allocated to 2 groups .
METHODS	Rusie Dutton group ( n = 24 ) practiced Rusie Dutton conducted by Wat Pho Thai Traditional Massage School for 13 weeks .
METHODS	The control group ( n = 26 ) was assigned to a waiting list and received no intervention .
METHODS	BW , BMI , restingHR , BP , flexibility , VO2max , and MENQOL including vasomotor , physical , psychosocial and sexual domains were measured at the beginning and the end .
METHODS	A paired-sample t-test and independent sample t-test were used for statistical analysis .
RESULTS	Significant improvement was found in all variables within group ( p < .05 ) in Rusie Dutton group , and a significant difference between groups was found ( p < .05 ) in all variables except BW and BMI .
RESULTS	Therefore , it is concluded that the traditional Thai exercise Rusie Dutton can promote health related physical fitness and QOL in menopausal women .

###24962470
OBJECTIVE	To compare cefazolin concentrations in biopsied tissue samples collected from surgically created wounds treated with negative pressure wound therapy to those collected from surgically created wounds treated with nonadherent dressings .
METHODS	Prospective , controlled , experimental study .
METHODS	Adult female spayed Beagles ( n = 12 ) .
METHODS	Full thickness cutaneous wounds were created on each antebrachium ( n = 24 ) .
METHODS	Immediately after surgery , cefazolin ( 22mg/kg intravenously [ IV ] ) was administered to each dog and continued every 8hours during the study .
METHODS	The right wound was randomly assigned to group I or group II whereas the wound on the contralateral antebrachium was assigned to the other group .
METHODS	Group I wounds were treated with negative pressure wound therapy ( NPWT ) and group II wounds were treated with nonadherent dressings for 3 days .
METHODS	Dressings were changed and tissue biopsies obtained from wound beds at 24hours intervals for both groups .
METHODS	Cefazolin wound tissue and plasma concentrations were measured by liquid chromatography mass spectrometry ( LC-MS/MS ) .
METHODS	Blood samples for measuring plasma cefazolin concentrations were collected before biopsy sampling .
METHODS	At the time of surgery and at each subsequent bandage change , wound beds were swabbed and submitted for aerobic and anaerobic culture .
RESULTS	After initiating cefazolin treatment , wound tissue antibiotic concentrations between treatment groups were not significantly different at any sampling time .
RESULTS	Similarly , after initiating cefazolin treatment , plasma cefazolin concentrations were not significantly different at any sampling time for individual dogs .
CONCLUSIONS	Using a canine experimental model , NPWT treatment of surgically created wounds does not statistically impact cefazolin tissue concentrations when compared with conventional nonadherent bandage therapy .

###25398294
OBJECTIVE	The objective of this study was to evaluate the influence of cardiopulmonary bypass ( CPB ) on endothelin-1 ( ET-1 ) expression in various circulation compartments in patients undergoing myocardial revascularization .
METHODS	A total of 30 patients were randomized to undergo myocardial revascularization with ( CABG , n = 15 ) or without ( OPCAB , n = 15 ) CPB .
METHODS	Samples were taken preoperatively , after establishing CPB and after CPB ( CABG group ) , prior to and after revascularization ( OPCAB group ) , and 6 and 24 h postoperatively .
METHODS	Values of ET-1 were compared between groups at all time points and correlated with postoperative cardioselective enzyme values and clinical parameters .
RESULTS	In OPCAB group , ET-1 levels did not significantly vary between time points .
RESULTS	In CABG group , ET-1 levels were significantly elevated vs. baseline in arterial : ART-T2 vs. ART-T0 ( 1.83 1.81 vs. 0.76 1.07 fmol/mL , p = 0.05 ) , pulmonary : SG-T2 vs. SG-T0 ( 2.70 2.75 vs. 0.39 0.28 fmol/mL , p < 0.001 ) and SG-T3 vs. SG-T0 ( 1.56 0.28 vs. 0.39 0.28 fmol/mL , p < 0.001 ) , and coronary circulation CS-T2 vs. CS-T1 ( 1.12 0.49 vs. 0.27 0.09 fmol/mL , p = 0.01 ) .
RESULTS	ET-1 levels were significantly higher in CABG group in all vascular compartments : ART-T2 ( 1.83 1.81 vs. 0.17 0.16 fmol/mL , p = 0.02 ) , ART-T4 ( 0.99 0.56 vs. 0.24 0.12 fmol/mL , p = 0.01 ) , SG-T1 ( 0.59 0.15 vs. 0.25 0.13 fmol/mL , p = 0.01 ) , SG-T2 ( 2.70 2.75 vs. 0.30 0.24 fmol/mL , p = 0.004 ) , SG-T3 ( 1.56 0.28 vs. 0.35 0.31 fmol/mL , p < 0.001 ) , SG-T4 ( 1.34 0.11 vs. 0.34 0.16 fmol/mL , p < 0.001 ) , and CS-T2 ( 1.12 0.49 vs. 0.12 0.12 fmol/mL , p = 0.004 ) .
RESULTS	Coronary sinus ET-1 level after CPB ( CS-T2 ) in CABG group correlated positively with troponin-I level 24 h postoperatively ( r ( 2 ) = 0.802 , p = 0.02 ) CONCLUSION : Off-pump myocardial revascularization attenuates ET-1 expression in all investigated vascular compartments .
RESULTS	Elevated coronary ET-1 levels after CPB in CABG group correlate with troponin-I levels 24 h postoperatively .

###24354541
OBJECTIVE	To compare open and closed methods of the frontalis suspension operation with a silicone rod in the treatment of congenital blepharoptosis .
METHODS	Forty-four cases with unilateral or bilateral congenital ptosis with a poor levator function of < 4 mm were divided randomly into two groups .
METHODS	Each group underwent an eyelid crease incision operation ( open ) or a supralash stab incision ( closed ) .
METHODS	Ptosis was measured by the difference between the upper eyelid margin reflex distance ( MRD ) of the affected eyelids of the unilateral and bilateral cases .
METHODS	Frequent follow-up examinations were performed up to 12 months post-surgery .
RESULTS	Associated ophthalmologic findings showed that amblyopia , strabismus , wound discharge and knot dehiscence problems were present in 36.6 % , 27.3 % , 8.5 % and 8.5 % of the patients , respectively .
RESULTS	There was no significant difference between the abovementioned associated ophthalmic findings of the two operative methods studied ( P = 0.37 ) .
RESULTS	The difference in the surgical methods and MRD 3 , 6 and 12 months after operation did not reach statistical significance .
RESULTS	Similar results for good MRD ( 3 < MRD < 5 ) were found in closed ( 54.5 % , 12/22 ) and open ( 54.5 % , 12/22 ) methods , while 40.9 % ( 9/22 ) and 45.5 % ( 10/22 ) of cases were attributed to the under correction group in the closed and open methods , respectively .
RESULTS	In bilaterally operated cases , MRD was more symmetrical than in unilaterally operated eyes .
RESULTS	The symmetry of MRD and the eyelid crease was more prevalent in the open technique group .
CONCLUSIONS	The frontalis sling operation using a silicone rod exhibited better results , in terms of symmetry , in the open technique in comparison to the closed method .

###25027749
BACKGROUND	Sepsis complication is a major cause of death in multiple trauma critically ill patients .
BACKGROUND	Defensin ( cysteine rich anti-microbial peptides ) , as an important component of immune system , might play an important role in this process .
BACKGROUND	There is also rising data on immunological effects of N-acetyl-cysteine ( NAC ) , a commonly used anti-oxidant in oxidative stress conditions and glutathione ( GSH ) deficiencies .
BACKGROUND	The aim of the present study was to evaluate the potential beneficial effects of NAC administration on multiple trauma patients with sepsis .
METHODS	In a prospective , randomized controlled study , 44 multiple trauma critically ill patients who were mechanically ventilated and met the criteria of sepsis and admitted to the intensive care unit ( ICU ) were randomized into two groups .
METHODS	Control group received all standard ICU therapies and NAC group received intravenous NAC 3 gr every 6 hours for 72 hours in addition to standard therapies .
METHODS	Acute Physiology and Chronic Health Evaluation II ( APACHE II ) and Sequential Organ Failure Assessment ( SOFA ) scores , length of ICU stay , ICU mortality were recorded .
METHODS	Levels of serum Immunoglobulin M ( IgM ) , Human - Defensin 2 ( HD2 ) and GSH were assessed at baseline and 24 , 72 , 120 hours after intervention .
RESULTS	During a period of 13-month screening , 44 patients underwent randomization but 5 patients had to be excluded .
RESULTS	21 patients in NAC group and 18 patients in control group completed the study .
RESULTS	For both groups the length of ICU stay , SOFA score and systemic oxygenation were similar .
RESULTS	Mortality rate ( 40 % vs. 22 % respectively , p = 0.209 ) and ventilator days ( MeanSD 19.8219.55 days vs. 13.8211.89 days respectively , p = 0.266 ) were slightly higher for NAC group .
RESULTS	IgM and GSH levels were similar between two groups ( p = 0.325 , 0.125 respectively ) , HD2 levels were higher for NAC group ( at day 3 ) .
CONCLUSIONS	High dose of NAC administration not only did not improve patients ' outcome , but also raised the risk of inflammation and was associated with increased serum creatinine .

###24743460
OBJECTIVE	The aim of this study was to examine proprioceptive performance in adults with hemiplegic cerebral palsy and the possibility that a home-based sensorimotor training program could improve proprioceptive performance .
METHODS	This study is a preintervention/postintervention assessment of 12 adults participating in a home-based program consisting of targeted unilateral and bilateral reaching movements , hand manipulation tasks , tactile discrimination , and stereognosis .
METHODS	It did not specifically include proprioceptive tasks .
METHODS	Training sessions were 45 mins , 5 days per week , for 8 wks .
METHODS	Limb position sense was assessed using three conditions : ipsilateral remembered ( same arm used for reference and matching targets ) , contralateral concurrent ( reference arm moved and held at target position while opposite arm matched reference position ) , and contralateral remembered ( reference arm moved to target position and then returned to start position before opposite arm matching position ) .
RESULTS	The participants demonstrated greater absolute and constant error when the more affected arm served as the reference arm , and matching was performed by the less affected arm , particularly in the contralateral remembered condition .
RESULTS	After training , the participants demonstrated less absolute error across matching tasks and no change in constant error .
CONCLUSIONS	The results suggest an important role for the reference arm in bilateral position matching tasks and the potential for improved proprioceptive performance after training in movement and unrelated sensory tasks .

###25579833
BACKGROUND	Suicidal behaviours in adolescents are a major public health problem and evidence-based prevention programmes are greatly needed .
BACKGROUND	We aimed to investigate the efficacy of school-based preventive interventions of suicidal behaviours .
METHODS	The Saving and Empowering Young Lives in Europe ( SEYLE ) study is a multicentre , cluster-randomised controlled trial .
METHODS	The SEYLE sample consisted of 11,110 adolescent pupils , median age 15 years ( IQR 14-15 ) , recruited from 168 schools in ten European Union countries .
METHODS	We randomly assigned the schools to one of three interventions or a control group .
METHODS	The interventions were : ( 1 ) Question , Persuade , and Refer ( QPR ) , a gatekeeper training module targeting teachers and other school personnel , ( 2 ) the Youth Aware of Mental Health Programme ( YAM ) targeting pupils , and ( 3 ) screening by professionals ( ProfScreen ) with referral of at-risk pupils .
METHODS	Each school was randomly assigned by random number generator to participate in one intervention ( or control ) group only and was unaware of the interventions undertaken in the other three trial groups .
METHODS	The primary outcome measure was the number of suicide attempt ( s ) made by 3 month and 12 month follow-up .
METHODS	Analysis included all pupils with data available at each timepoint , excluding those who had ever attempted suicide or who had shown severe suicidal ideation during the 2 weeks before baseline .
METHODS	This study is registered with the German Clinical Trials Registry , number DRKS00000214 .
RESULTS	Between Nov 1 , 2009 , and Dec 14 , 2010 , 168 schools ( 11,110 pupils ) were randomly assigned to interventions ( 40 schools [ 2692 pupils ] to QPR , 45 [ 2721 ] YAM , 43 [ 2764 ] ProfScreen , and 40 [ 2933 ] control ) .
RESULTS	No significant differences between intervention groups and the control group were recorded at the 3 month follow-up .
RESULTS	At the 12 month follow-up , YAM was associated with a significant reduction of incident suicide attempts ( odds ratios [ OR ] 045 , 95 % CI 024-085 ; p = 0014 ) and severe suicidal ideation ( 050 , 027-092 ; p = 0025 ) , compared with the control group .
RESULTS	14 pupils ( 070 % ) reported incident suicide attempts at the 12 month follow-up in the YAM versus 34 ( 151 % ) in the control group , and 15 pupils ( 075 % ) reported incident severe suicidal ideation in the YAM group versus 31 ( 137 % ) in the control group .
RESULTS	No participants completed suicide during the study period .
CONCLUSIONS	YAM was effective in reducing the number of suicide attempts and severe suicidal ideation in school-based adolescents .
CONCLUSIONS	These findings underline the benefit of this universal suicide preventive intervention in schools .
BACKGROUND	Coordination Theme 1 ( Health ) of the European Union Seventh Framework Programme .

###24903522
BACKGROUND	Bolus injections of intravenous propofol and remifentanil can be used in the tracheal intubation of infants and children , but relatively large doses are needed .
BACKGROUND	We hypothesised that addition of a small bolus of rocuronium would ensure good intubation conditions when modest propofol and remifentanil doses were used .
METHODS	Seventy infants between 3 weeks and 4 months of age were randomised to receive either placebo or rocuronium .
METHODS	Anaesthesia was induced with IV propofol , 3 ( 3-5 ) mg/kg [ median ( range ) ] .
METHODS	Rocuronium ( 0.2 mg/kg ) or placebo was then injected , followed 15s later by 2g/kg remifentanil .
METHODS	One anaesthetist attempted tracheal intubation 1min after the rocuronium/placebo injection and used the ` Copenhagen scoring system ' to assess intubation conditions .
METHODS	The neuromuscular effect of 0.2 mg/kg rocuronium was recorded in another eight , already intubated , infants using thumb accelerometry during train-of-four stimulation of the ulnar nerve .
RESULTS	Intubation conditions were classified as ` poor ' in 14 of 34 ( 41 % ) patients given placebo and in 10 of 36 ( 28 % ) patients given rocuronium ( P = 0.32 ) .
RESULTS	There were four failed first attempts at intubation in the placebo group and none in the rocuronium group ( P = 0.051 ) .
RESULTS	Maximum neuromuscular depression occurred 4 ( 3-8 ) after injection of 0.2 mg/kg rocuronium .
CONCLUSIONS	Intubation conditions were poor in almost one third of the patients receiving propofol-remifentanil .
CONCLUSIONS	Adding a low-dose rocuronium did not significantly improve intubation conditions .

###25335251
OBJECTIVE	To compare the difference in the clinical efficacy on primary trigeminal neuralgia ( PTN ) between the comprehensive therapy of electroacupuncture ( EA ) at qi streets acupoints combined with spinal regulation method and medication with carbamazepine ( CBZ ) .
METHODS	Sixty patients were randomized into a comprehensive therapy group ( 30 cases ) and a medication group ( 30 cases ) .
METHODS	In the comprehensive therapy group , the acupoints at qi streets on the head such as Taiyang ( EX-HN 5 ) and Sishencong ( EX-HN 1 ) and those at qi streets on the chest and abdomen such as Shenshu ( BL 23 ) , Zhongwan ( CV 12 ) and Guanyuan ( CV 4 ) , etc. were selected .
METHODS	After arrival of qi , EA was attached on 2 to 4 groups of acupoints .
METHODS	After acupuncture , the spinal regulation method was applied .
METHODS	This comprehensive therapy was given once a day .
METHODS	In the medication group , CBZ was used for oral administration , 100 mg at the first time , twice a day , and 400 to 600 mg each day as the maintenance dose .
METHODS	Separately , before and after treatment , in 2 and 6 months in follow-up , pain rating index ( PRI ) , life satisfaction index B ( LSI-B ) and hamilton depression scale ( HAMD ) were adopted to evaluate comprehensively the clinical efficacy in the two groups and compare the adverse reaction during the treatment between the two groups .
RESULTS	After treatment , the curative and markedly effective rate in the comprehensive therapy group was 76.7 % ( 23/30 ) , which was better than 63.3 % ( 19/30 ) in the medication group ( P < 0.01 ) .
RESULTS	The difference in PRI was not significant after treatment between the two groups ( all P > 0.05 ) .
RESULTS	In 2 and 6 months follow-up , PRI grade in the comprehensive therapy group was superior to that of the medication group ( both P < 0.05 ) .
RESULTS	After treatment and in follow-up , HAMD score was all reduced in the two groups ( P < 0.01 , P < 0.05 ) and the result in follow-up in the comprehensive therapy group was significant as compared with that in the medication group ( all P < 0.05 ) .
RESULTS	After treatment , LSI-B score was increased obviously in the two groups ( all P < 0.05 ) and the result in the comprehensive therapy group was better than that in the medication group ( P < 0.05 ) .
RESULTS	The incidence of adverse reaction in the comprehensive therapy group was 16.7 % ( 5/30 ) , which was lower than 30.0 % ( 9/30 , P < 0.01 ) in the medication group .
CONCLUSIONS	The comprehensive therapy of EA at qi streets acpoints combined with spinal regulation method achieves the long-term efficacy on PTN as compared with oral administration of CBZ in terms of the improvement of psychological condition , analgesia and life quality .
CONCLUSIONS	It is the safe , effective and stable therapy .

###24571395
OBJECTIVE	To evaluate the effectiveness of chest physiotherapy ( CPT ) , which provides slow and long expiratory flow and assisted cough techniques , in infants receiving outpatient care for acute wheezing episodes .
METHODS	Forty-eight infants with moderate acute wheezing episodes were randomised to receive either salbutamol MDI with CPT ( n = 25 ) or without CPT ( n = 23 ) .
METHODS	The clinical score and SpO2 levels were recorded , before and after treatment , in a blinded design .
METHODS	The primary outcome was discharge after the first hour of treatment : clinical score 5/12 and SpO2 93 % .
METHODS	Secondary outcomes were the number of admissions to hospital after the second hour , use of oral corticosteroid bursts and admissions to hospital on day seven .
RESULTS	There were no differences between children with and without CPT in discharge rate ( 92 % vs. 87 % ) , clinical score ( median [ IQR ] : 2.8 [ 2.2-3 .3 ] vs. 3.4 [ 2.8-4 .1 ] ) and SpO2 = ( 96.4 [ 95.7-97 .1 ] vs. 96.0 [ 94.9-96 .5 ] ) after the first hour of treatment or in the number of hospital admissions after the second hour .
RESULTS	No differences were observed at days seven and 28 following treatment .
CONCLUSIONS	There was no evidence of clinical benefits from these specific CPT techniques for infants receiving outpatient care for acute wheezing episodes .

###24832191
BACKGROUND	- alanine ( BAl ) and NaHCO3 ( SB ) ingestion may provide performance benefits by enhancing concentrations of their respective physiochemical buffer counterparts , muscle carnosine and blood bicarbonate , counteracting acidosis during intense exercise .
BACKGROUND	This study examined the effect of BAl and SB co-supplementation as an ergogenic strategy during high-intensity exercise .
METHODS	Eight healthy males ingested either BAl ( 4.8 g day ( -1 ) for 4 weeks , increased to 6.4 g day ( -1 ) for 2 weeks ) or placebo ( Pl ) ( CaCO3 ) for 6 weeks , in a crossover design ( 6-week washout between supplements ) .
METHODS	After each chronic supplementation period participants performed two trials , each consisting of two intense exercise tests performed over consecutive days .
METHODS	Trials were separated by 1 week and consisted of a repeated sprint ability ( RSA ) test and cycling capacity test at 110 % Wmax ( CCT110 % ) .
METHODS	Placebo ( Pl ) or SB ( 300 mg kgbw ( -1 ) ) was ingested prior to exercise in a crossover design to creating four supplement conditions ( BAl-Pl , BAl-SB , Pl-Pl , Pl-SB ) .
RESULTS	Carnosine increased in the gastrocnemius ( n = 5 ) ( p = 0.03 ) and soleus ( n = 5 ) ( p = 0.02 ) following BAl supplementation , and Pl-SB and BAl-SB ingestion elevated blood HCO3 ( - ) concentrations ( p < 0.01 ) .
RESULTS	Although buffering capacity was elevated following both BAl and SB ingestion , performance improvement was only observed with BAl-Pl and BAl-SB increasing time to exhaustion of the CCT110 % test 14 and 16 % , respectively , compared to Pl-Pl ( p < 0.01 ) .
CONCLUSIONS	Supplementation of BAl and SB elevated buffering potential by increasing muscle carnosine and blood bicarbonate levels , respectively .
CONCLUSIONS	BAl ingestion improved performance during the CCT110 % , with no aggregating effect of SB supplementation ( p > 0.05 ) .
CONCLUSIONS	Performance was not different between treatments during the RSA test .

###24271139
BACKGROUND	Glycated proteins ( advanced glycation endproducts , AGE ) in tissue are associated with degenerative diseases .
BACKGROUND	This study evaluated the role of sRAGE ( soluble receptor for advanced glycation endproducts ) , a decoy receptor of AGEs in blood , for the outcome of patients after coronary artery bypass grafting ( CABG ) .
METHODS	A total of 90 patients undergoing CABG were analysed in two centres .
METHODS	Perioperative blood samples were collected before surgery up to 1week postoperatively .
METHODS	sRAGE was measured by ELISA .
METHODS	Patients were subdivided regarding age ( < 64 versus > 70years , 14 % versus 35 % female ) , euroSCORE ( < 3 versus > 4 , 14 % versus 29 % female ) and sRAGE changes between sternotomy and end of the operation ( < 30 % versus > 45 % , 33 % versus 33 % female ) and subsequently analysed with respect of postoperative outcome parameters .
RESULTS	Preoperative sRAGE values did not correlate with the outcome of the patients .
RESULTS	sRAGE levels increase within 10min from 1,53996 to 5,311187 pg/ml after sternotomy , then returning to baseline levels within 2days after surgery .
RESULTS	Comparing the analysed possible risk factors age , euroSCORE and sRAGE changes , no difference was observed regarding 30-day mortality .
RESULTS	Age and the euroSCORE are superior with respect of tachyarrythmia , whereas sRAGE kinetics seems to be superior with respect of prolonged postoperative respiration time/stay in the intensive care unit or catecholamine support .
CONCLUSIONS	A prolonged , increased intraoperative sRAGE level is a new outcome predictor for patients undergoing CABG surgery , mutually complementary to the euroSCORE .

###25118076
OBJECTIVE	Scarce physical activity predicts shorter survival in dialysis patients .
OBJECTIVE	However , the relationship between physical ( motor ) fitness and clinical outcomes has never been tested in these patients .
METHODS	We tested the predictive power of an established metric of motor fitness , the Six-Minute Walking Test ( 6MWT ) , for death , cardiovascular events and hospitalization in 296 dialysis patients who took part in the trial EXCITE ( ClinicalTrials.gov Identifier : NCT01255969 ) .
RESULTS	During follow up 69 patients died , 90 had fatal and non-fatal cardiovascular events , 159 were hospitalized and 182 patients had the composite outcome .
RESULTS	In multivariate Cox models - including the study allocation arm and classical and non-classical risk factors - an increase of 20 walked metres during the 6MWT was associated to a 6 % reduction of the risk for the composite end-point ( P = 0.001 ) and a similar relationship existed between the 6MWT , mortality ( P < 0.001 ) and hospitalizations ( P = 0.03 ) .
RESULTS	A similar trend was observed for cardiovascular events but this relationship did not reach statistical significance ( P = 0.09 ) .
CONCLUSIONS	Poor physical performance predicts a high risk of mortality , cardiovascular events and hospitalizations in dialysis patients .
CONCLUSIONS	Future studies , including phase-2 EXCITE , will assess whether improving motor fitness may translate into better clinical outcomes in this high risk population .

###25902745
BACKGROUND	Wire-guided cannulation has become a common biliary cannulation technique worldwide .
BACKGROUND	Different guidewires with various tip shapes and materials have been reportedly used for wire-guided cannulation .
BACKGROUND	However , there are apparently no studies reporting changes in the biliary cannulation rate according to the type of guidewire used .
OBJECTIVE	We evaluated the effectiveness of the J-tip guidewire for biliary cannulation .
METHODS	We conducted a prospective , multicenter , controlled study involving patients with a native papilla who required biliary cannulation .
METHODS	We allocated the patients to the J-tip guidewire or angled-tip guidewire groups ( groups J and A , respectively ) .
METHODS	If biliary cannulation was not achieved within 10min , the GW was changed and cannulation was continued .
RESULTS	Groups J and A consisted of 66 and 65 enrolled patients , respectively .
RESULTS	The biliary cannulation rate with a single guidewire for the first 10min was 84.8 % ( 56/66 ) for group J and 80.0 % ( 52/65 ) for group A.
RESULTS	The final success rate for biliary cannulation was 100 % in both groups .
RESULTS	The mean times necessary for biliary cannulation were 285.8 and 267.6 s in group J and group A , respectively .
RESULTS	The incidence rates of complications ( i.e. , all mild pancreatitis ) were 3.0 % ( 2/66 ) and 6.2 % ( 4/65 ) in group J and group A , respectively .
RESULTS	The mean amylase concentrations were 168.0 and 297.7 IU/L in group J and group A , respectively .
RESULTS	There were no significant differences in any results between both groups .
CONCLUSIONS	The biliary cannulation rate of the J-tip guidewire was not significantly different from those of standard guidewires .

###25556220
BACKGROUND	Recent biomechanical evidence suggests that the meniscus-suture interface contributes the most displacement to the transtibial pull-out repair for meniscal root tears .
BACKGROUND	Therefore , optimization of surgical technique at the meniscus-suture interface may minimize displacement and improve the strength of meniscal root repairs .
OBJECTIVE	The purpose of this study was to investigate the cyclic displacement and ultimate failure loads of 4 different meniscus-suture fixation techniques for posterior medial meniscal root repairs in human meniscus tissue .
OBJECTIVE	The hypothesis was that there would be no significant difference between the two simple sutures ( TSS ) technique and 3 other techniques in cyclic displacement or ultimate failure load .
METHODS	Controlled laboratory study .
METHODS	A total of 32 fresh-frozen , human , medial meniscal transplant specimens were randomly assigned to 4 meniscus-suture fixation techniques used for transtibial pull-out repair in posterior medial meniscal root tears ( n = 8 per group ) .
METHODS	The suture techniques studied were ( 1 ) TSS , ( 2 ) modified Mason-Allen ( MMA ) , ( 3 ) single double-locking loop ( S-DLL ) , and ( 4 ) double double-locking loop ( D-DLL ) .
METHODS	The menisci were subjected to a cyclic tensioning protocol representative of postoperative rehabilitation ( 10-30 N for 1000 cycles ) and pulled to failure at a rate of 0.5 mm/s .
RESULTS	After 1000 cycles , the TSS group displaced the least ( mean SD , 1.78 0.64 mm ) , followed by the MMA ( 2.14 0.65 mm ) , D-DLL ( 2.97 0.57 mm ) , and S-DLL ( 3.81 0.78 mm ) groups .
RESULTS	After 100 , 500 , and 1000 cycles , suture displacements using the TSS and MMA techniques were not significantly different ( P > .13 ) , while the TSS technique resulted in significantly less displacement than the S-DLL and D-DLL ( P < .03 ) techniques .
RESULTS	The ultimate failure loads of the MMA ( 325 77 N ) and D-DLL ( 320 50 N ) techniques were significantly greater than those of the TSS ( 192 52 N ) and S-DLL ( 217 51 N ) techniques ( P < .05 ) .
CONCLUSIONS	The TSS and MMA fixation techniques were not significantly different , while the TSS was significantly better at resisting displacement when compared with the S-DLL and D-DLL stitch configurations .
CONCLUSIONS	The MMA and D-DLL techniques exhibited significantly greater failure loads than did the TSS and S-DLL techniques ; however , all techniques demonstrated ultimate failure loads above the currently accepted rehabilitation force threshold .
CONCLUSIONS	The TSS fixation technique combines the lowest technical difficulty and the ability to resist displacement at time zero .
CONCLUSIONS	The MMA technique , although more technically challenging , may provide an alternative means to resist displacement while enhancing the failure load .

###25424567
BACKGROUND	Transcranial direct current stimulation ( tDCS ) of the primary motor cortex has been shown to modulate pain and trigeminal nociceptive processing .
METHODS	Ten patients with classical trigeminal neuralgia ( TN ) were stimulated daily for 20minutes over two weeks using anodal ( 1mA ) or sham tDCS over the primary motor cortex ( M1 ) in a randomized double-blind cross-over design .
METHODS	Primary outcome variable was pain intensity on a verbal rating scale ( VRS 0-10 ) .
METHODS	VRS and attack frequency were assessed for one month before , during and after tDCS .
METHODS	The impact on trigeminal pain processing was assessed with pain-related evoked potentials ( PREP ) and the nociceptive blink reflex ( nBR ) following electrical stimulation on both sides of the forehead before and after tDCS .
RESULTS	Anodal tDCS reduced pain intensity significantly after two weeks of treatment .
RESULTS	The attack frequency reduction was not significant .
RESULTS	PREP showed an increased N2 latency and decreased peak-to-peak amplitude after anodal tDCS .
RESULTS	No severe adverse events were reported .
CONCLUSIONS	Anodal tDCS over two weeks ameliorates intensity of pain in TN .
CONCLUSIONS	It may become a valuable treatment option for patients unresponsive to conventional treatment .

###24716713
BACKGROUND	Type 2 diabetes , also known non-insulin-dependent diabetes , is the most prevalent type of the disease and involves defects in the secretion and action of insulin .
BACKGROUND	The aim of the proposed study is to evaluate the efficacy of pre-exercise low-level laser therapy ( LLLT ) on muscle performance of the quadriceps femoris in individuals with type 2 diabetes .
METHODS	A double-blind , randomized , controlled clinical trial will be carried out in two treatment phases .
METHODS	In the first phase , quadriceps muscle performance will be evaluated using an isokinetic dynamometer and the levels of creatine kinase and lactate dehydrogenase ( biochemical markers of muscle damage ) will be determined .
METHODS	The participants will then be allocated to four LLLT groups through a randomization process using opaque envelopes : Group A ( 4 Joules ) , Group B ( 6 Joules ) , Group C ( 8 Joules ) and Group D ( 0 Joules ; placebo ) .
METHODS	Following the administration of LLLT , the participants will be submitted to an isokinetic eccentric muscle fatigue protocol involving the quadriceps muscle bilaterally .
METHODS	Muscle performance and biochemical markers of muscle damage will be evaluated again immediately after as well as 24 and 48hours after the experimental protocol .
METHODS	One week after the last evaluation the second phase will begin , during which Groups A , B and C will receive the LLLT protocol that achieved the best muscle performance in phase 1 for a period of 4weeks .
METHODS	At the end of this period , muscle performance will be evaluated again .
METHODS	The protocol for this study is registered with the World Health Organization under Universal Trial Number U1111-1146-7109 .
CONCLUSIONS	The purpose of this randomized clinical trial is to evaluate the efficacy of pre-exercise LLLT on the performance of the quadriceps muscle ( peak torque , total muscle work , maximum power and fatigue index - normalized by body mass ) in individuals with DM-2 .
CONCLUSIONS	The study will support the practice of evidence-based to the use of LLLT in improving muscle performance in Individuals with DM-2 .
CONCLUSIONS	Data will be published after the study is completed .

###24645632
BACKGROUND	Skin cancer survivors experience an increased risk for subsequent malignancies but the associated risk factors are poorly understood .
BACKGROUND	This study examined the risk of a new primary cancer following an initial skin cancer and assessed risk factors associated with second primary cancers .
METHODS	All invasive cutaneous malignant melanomas ( CMM , N = 28 069 ) and squamous cell carcinomas ( SCC , N = 24 620 ) diagnosed in Norway during 1955-2008 were included .
METHODS	Rates of new primary cancers in skin cancer survivors were compared to rates of primary malignancies in the general population using standardized incidence ratios ( SIR ) .
METHODS	Discrete-time logistic regression models were applied to individual-level data to estimate cancer risk among those with and without a prior skin cancer , accounting for residential region , education , income , parenthood , marital status and parental cancer status , using a 20 % random sample of the entire Norwegian population as reference .
METHODS	Further analyses of the skin cancer cohort were undertaken to determine risk factors related to subsequent cancers .
RESULTS	During follow-up , 9608 new primary cancers occurred after an initial skin cancer .
RESULTS	SIR analyses showed 50 % and 90 % increased risks for any cancer after CMM and SCC , respectively ( p < 0.01 ) .
RESULTS	The logistic regression model suggested even stronger increase after SCC ( 130 % ) .
RESULTS	The highest risk was seen for subsequent skin cancers , but several non-skin cancers were also diagnosed in excess : oral , lung , colon , breast , prostate , thyroid , leukemia , lymphoma and central nervous system .
RESULTS	Factors that were associated with increased risk of subsequent cancers include male sex , older age , lower residential latitude , being married and low education and income .
RESULTS	Parental cancer did not increase the risk of a subsequent cancer after SCC , but was a significant predictor among younger CMM survivors .
CONCLUSIONS	Our results provide information on shared environmental and genetic risk factors for first and later cancers and may help to identify individuals at high risk for subsequent cancers , which will be important as skin cancer incidence continues to rise .

###25321941
OBJECTIVE	The aim of this study was to evaluate the 6-month effect of a single automated thermodynamic treatment ( LipiFlow ) and implications of meibomian gland atrophy on treatment efficacy 6 months after application .
METHODS	We analyzed the data of 26 subjects with meibomian gland dysfunction before and 6 months after treatment .
METHODS	Investigated parameters included subjective symptoms , lipid layer thickness , meibomian gland assessment , tear osmolarity , corneal and conjunctival staining , lid margin parallel conjunctival folds , Schirmer test values , bulbar redness , tear meniscus height , meibomian gland atrophy , and noninvasive tear break-up time .
RESULTS	Subjective symptoms ( mean Ocular Surface Disease Index , 42 19 to 33 21 ; P = 0.004 , mean Standard Patient Evaluation of Eye Dryness 16 7 to 12 7 ; P = 0.0001 ) , lipid layer thickness ( 44.0 15.6 to 51.3 20.4 ; P = 0.014 ) , number of expressible glands ( 2.9 1.6 to 6.4 4.6 ; P < 0.0001 ) , lid margin parallel conjunctival folds ( 2.3 1.0 to 2.0 0.9 ; P = 0.04 ) , and bulbar redness ( 1.4 0.5 to 1.2 0.5 ; P = 0.0001 ) were all improved 6 months after treatment .
RESULTS	Symptomatic improvement was higher in patients with less severe meibomian gland atrophy compared with patients with more dropout at treatment .
RESULTS	There was no change of meibomian gland atrophy 6 months after treatment .
CONCLUSIONS	In summary , the results showed that a single thermodynamic treatment is effective in the treatment of meibomian gland dysfunction and that the effects last for at least 6 months .
CONCLUSIONS	We suggest performing meibography in every patient before treatment for better prediction of therapeutic effects .

###25151398
BACKGROUND	The aging process involves a decline in immune functioning that renders elderly people more vulnerable to disease .
BACKGROUND	In residential programs for the aged , it is vital to diminish their risk of disease , promote their independence , and augment their psychological well-being and quality of life .
METHODS	We performed a randomized controlled study , evaluating the ability of a relaxation technique based on Benson 's relaxation response to enhance psychological well-being and modulate the immune parameters of elderly people living in a geriatric residence when compared to a waitlist control group .
METHODS	The study included a 2-week intervention period and a 3-month follow-up period .
METHODS	The main outcome variables were psychological well-being and quality of life , biomedical variables , immune changes from the pre-treatment to post-treatment and follow-up periods .
RESULTS	Our findings reveal significant differences between the experimental and control groups in CD19 , CD71 , CD97 , CD134 , and CD137 lymphocyte subpopulations at the end of treatment .
RESULTS	Furthermore , there was a decrease in negative affect , psychological discomfort , and symptom perception in the treatment group , which increased participants ' quality of life scores at the three-month follow-up .
CONCLUSIONS	This study represents a first approach to the application of a passive relaxation technique in residential programs for the elderly .
CONCLUSIONS	The method appears to be effective in enhancing psychological well-being and modulating immune activity in a group of elderly people .
CONCLUSIONS	This relaxation technique could be considered an option for achieving health benefits with a low cost for residential programs , but further studies using this technique in larger samples of older people are needed to confirm the trends observed in the present study .
BACKGROUND	International Standard Randomised Controlled Trial Number Register ISRCTN85410212 .

###24827127
BACKGROUND	This phase II , open-label study investigated intercalated combinations of eribulin and erlotinib in unselected patients with advanced non-small-cell lung cancer previously treated with platinum-based chemotherapies .
METHODS	Eligible patients were randomized to eribulin mesylate 2.0 mg/m ( 2 ) on day 1 with erlotinib 150 mg on days 2-16 ( 21-day regimen ) or eribulin mesylate 1.4 mg/m ( 2 ) on days 1 and 8 with erlotinib 150 mg on days 15-28 ( 28-day regimen ) .
METHODS	The primary end point was objective response rate ( ORR ) .
RESULTS	One hundred and twenty-three patients received 1 cycle of therapy ( 63 , 21-day regimen ; 60 , 28-day regimen ) .
RESULTS	ORRs were 13 % [ 95 % confidence interval ( CI ) 6 % -24 % ] and 17 % ( 95 % CI 8 % -29 % ) , and disease control rates were 48 % ( 95 % CI 35 % -61 % ) and 63 % ( 95 % CI 50 % -75 % ) for the 21 - and 28-day regimens , respectively .
RESULTS	The median progression-free survival and overall survival were similar with both regimens .
RESULTS	Both regimens were well tolerated with common grade 3 toxicities being neutropenia , asthenia/fatigue , and dyspnoea .
RESULTS	Sequential administration of erlotinib did not interfere with the pharmacokinetic profile of eribulin .
CONCLUSIONS	Intercalated combination of eribulin and erlotinib demonstrated modest activity and the addition of erlotinib did not appear to improve treatment outcome in an unselected population .
CONCLUSIONS	The 28-day regimen is suitable for further investigation .
CONCLUSIONS	Clinicaltrials.gov identifier : NCT01104155 .

###25667244
OBJECTIVE	There is evidence that new methods of noninvasive ventilation ( NIV ) support have significantly changed respiratory distress syndrome ( RDS ) management in preterm infants .
OBJECTIVE	Further perspectives for neonatologists involve the assessment of different NIV strategies in terms of availability , effectiveness , and failure .
OBJECTIVE	This study evaluates the efficacy of 2 different NIV strategies for RDS treatment in very low birth weight ( VLBW ) infants : nasal synchronized intermittent positive pressure ventilation ( NSIPPV ) , which is a modality of conventional ventilation with intermittent peak inspiratory pressure , and bilevel continuous positive airway pressure ( BiPAP ) , not synchronized , with 2 alternate levels of continuous positive airway pressure .
METHODS	We conducted a 2-center randomized control study in 124 VLBW infants ( < 1500 g and < 32 weeks of gestational age ) with RDS who received NIV support ( NSIPPV , n = 62 ; BiPAP , n = 62 ) within 2 hours of birth .
METHODS	We evaluated the performance of NIV strategies by selected primary outcomes ( failure rate and duration of ventilation ) and secondary outcomes .
RESULTS	The number of failures and duration of ventilation support did not differ between NSIPPV and BiPAP strategies ( P > .05 for both ) .
RESULTS	Moreover , no differences between groups were found regarding secondary outcomes ( P > .05 for all ) .
CONCLUSIONS	The present data show no statistically significant differences between NSIPPV and BiPAP strategies in terms of duration of ventilation and failures , suggesting that both NIV techniques are effective in the early treatment of RDS in VLBW infants .
CONCLUSIONS	Further randomized investigations on wider populations are needed to evaluate the effect of NIV techniques on long-term outcomes .

###25853744
BACKGROUND	Among patients undergoing mitral-valve surgery , 30 to 50 % present with atrial fibrillation , which is associated with reduced survival and increased risk of stroke .
BACKGROUND	Surgical ablation of atrial fibrillation has been widely adopted , but evidence regarding its safety and effectiveness is limited .
METHODS	We randomly assigned 260 patients with persistent or long-standing persistent atrial fibrillation who required mitral-valve surgery to undergo either surgical ablation ( ablation group ) or no ablation ( control group ) during the mitral-valve operation .
METHODS	Patients in the ablation group underwent further randomization to pulmonary-vein isolation or a biatrial maze procedure .
METHODS	All patients underwent closure of the left atrial appendage .
METHODS	The primary end point was freedom from atrial fibrillation at both 6 months and 12 months ( as assessed by means of 3-day Holter monitoring ) .
RESULTS	More patients in the ablation group than in the control group were free from atrial fibrillation at both 6 and 12 months ( 63.2 % vs. 29.4 % , P < 0.001 ) .
RESULTS	There was no significant difference in the rate of freedom from atrial fibrillation between patients who underwent pulmonary-vein isolation and those who underwent the biatrial maze procedure ( 61.0 % and 66.0 % , respectively ; P = 0.60 ) .
RESULTS	One-year mortality was 6.8 % in the ablation group and 8.7 % in the control group ( hazard ratio with ablation , 0.76 ; 95 % confidence interval , 0.32 to 1.84 ; P = 0.55 ) .
RESULTS	Ablation was associated with more implantations of a permanent pacemaker than was no ablation ( 21.5 vs. 8.1 per 100 patient-years , P = 0.01 ) .
RESULTS	There were no significant between-group differences in major cardiac or cerebrovascular adverse events , overall serious adverse events , or hospital readmissions .
CONCLUSIONS	The addition of atrial fibrillation ablation to mitral-valve surgery significantly increased the rate of freedom from atrial fibrillation at 1 year among patients with persistent or long-standing persistent atrial fibrillation , but the risk of implantation of a permanent pacemaker was also increased .
CONCLUSIONS	( Funded by the National Institutes of Health and the Canadian Institutes of Health Research ; ClinicalTrials.gov number , NCT00903370 . )

###24664227
OBJECTIVE	Coenzyme Q10 ( CoQ10 ) , an antioxidant that supports mitochondrial function , has been shown in preclinical Parkinson disease ( PD ) models to reduce the loss of dopamine neurons , and was safe and well tolerated in early-phase human studies .
OBJECTIVE	A previous phase II study suggested possible clinical benefit .
OBJECTIVE	To examine whether CoQ10 could slow disease progression in early PD .
METHODS	A phase III randomized , placebo-controlled , double-blind clinical trial at 67 North American sites consisting of participants 30 years of age or older who received a diagnosis of PD within 5 years and who had the following inclusion criteria : the presence of a rest tremor , bradykinesia , and rigidity ; a modified Hoehn and Yahr stage of 2.5 or less ; and no anticipated need for dopaminergic therapy within 3 months .
METHODS	Exclusion criteria included the use of any PD medication within 60 days , the use of any symptomatic PD medication for more than 90 days , atypical or drug-induced parkinsonism , a Unified Parkinson 's Disease Rating Scale ( UPDRS ) rest tremor score of 3 or greater for any limb , a Mini-Mental State Examination score of 25 or less , a history of stroke , the use of certain supplements , and substantial recent exposure to CoQ10 .
METHODS	Of 696 participants screened , 78 were found to be ineligible , and 18 declined participation .
METHODS	The remaining 600 participants were randomly assigned to receive placebo , 1200 mg/d of CoQ10 , or 2400 mg/d of CoQ10 ; all participants received 1200 IU/d of vitamin E.
METHODS	Participants were observed for 16 months or until a disability requiring dopaminergic treatment .
METHODS	The prospectively defined primary outcome measure was the change in total UPDRS score ( Parts I-III ) from baseline to final visit .
METHODS	The study was powered to detect a 3-point difference between an active treatment and placebo .
RESULTS	The baseline characteristics of the participants were well balanced , the mean age was 62.5 years , 66 % of participants were male , and the mean baseline total UPDRS score was 22.7 .
RESULTS	A total of 267 participants required treatment ( 94 received placebo , 87 received 1200 mg/d of CoQ10 , and 86 received 2400 mg/d of CoQ10 ) , and 65 participants ( 29 who received placebo , 19 who received 1200 mg/d of CoQ10 , and 17 who received 2400 mg/d of CoQ10 ) withdrew prematurely .
RESULTS	Treatments were well tolerated with no safety concerns .
RESULTS	The study was terminated after a prespecified futility criterion was reached .
RESULTS	At study termination , both active treatment groups showed slight adverse trends relative to placebo .
RESULTS	Adjusted mean changes ( worsening ) in total UPDRS scores from baseline to final visit were 6.9 points ( placebo ) , 7.5 points ( 1200 mg/d of CoQ10 ; P = .49 relative to placebo ) , and 8.0 points ( 2400 mg/d of CoQ10 ; P = .21 relative to placebo ) .
CONCLUSIONS	Coenzyme Q10 was safe and well tolerated in this population , but showed no evidence of clinical benefit .
BACKGROUND	clinicaltrials.gov Identifier : NCT00740714 .

###24295838
BACKGROUND	Historically , the preoperative consultation has consisted of a discussion between patient and surgeon .
BACKGROUND	There is a growing literature describing efforts to integrate multimedia into surgical patient education .
BACKGROUND	This study aimed to assess the efficacy of an educational video tutorial on early learning of information specific to patients undergoing shoulder arthroscopy when it was used as an adjunct to the standard preoperative consultation .
METHODS	This study was a surgeon-blinded , randomized controlled trial involving 40 consecutive patients requiring shoulder arthroscopy .
METHODS	After a preoperative consultation with an orthopaedic surgeon , patients were randomized in a 1:1 ratio to either a control group or a treatment group .
METHODS	The treatment group viewed a 10-minute video , which covered the expected preoperative , intraoperative , and postoperative experience .
METHODS	Immediately afterward , both groups completed a questionnaire measuring satisfaction and recall of information received .
METHODS	All patients completed a second questionnaire at the first postoperative visit that assessed overall satisfaction with their experience .
RESULTS	Thirty-four patients were available for follow-up .
RESULTS	The video group ( N = 15 ) answered 87 % of the knowledge questions correctly , whereas the control group ( N = 19 ) answered only 56 % ( P = .000 ) .
RESULTS	There was stronger agreement in the video group that the preoperative consultation contained an appropriate amount of information ( P = .039 ) .
RESULTS	Postoperatively , there was agreement that the video was an effective preparation tool for all stages of the surgical experience .
RESULTS	However , there was no difference between the groups in satisfaction with their overall surgical experience .
CONCLUSIONS	Video can enhance patients ' operative experiences and improve their retained knowledge when it is used as an adjunct to the preoperative consultation .
METHODS	Basic science , education methodology study , devices to improve learning .

###25127550
OBJECTIVE	Postoperative pulmonary complications are a burden for high-risk surgical patients with a risk of aspiration of subglottic secretions along the polyvinyl chloride cuff .
OBJECTIVE	The introduction of a polyurethane cuff diminishes secretion leakage with a decreased rate of pneumonia .
OBJECTIVE	The aim of the current analysis was to determine the time at which a polyurethane cuffed endotracheal tube might be advantageous to prevent aspiration in a setting of high-risk surgical patients .
METHODS	The present investigation is based on published data obtained in postoperative cardiac surgical patients undergoing operation from 2006 to 2007 .
METHODS	Cuff pressure was kept between 20 and 26 cmH2O intraoperatively and in the intensive care unit .
METHODS	The current post hoc analysis determines ( 1 ) the discriminatory cutoff value of intubation duration for predicting postoperative pneumonia and ( 2 ) the potential factors associated with prolonged intubation .
RESULTS	Forty-three patients ( 32 % ) were diagnosed with early postoperative pneumonia .
RESULTS	Receiver operating characteristics analysis revealed a cutoff value of 16.6 hours for the duration of mechanical ventilation to discriminate patients with postoperative pneumonia .
RESULTS	A stepwise binary logistic regression analysis revealed that a polyvinyl chloride cuff was associated with a 10-fold increased risk for prolonged intubation .
CONCLUSIONS	The current analyses provide evidence that among cardiac surgical patients , mechanical ventilation more than 16.6 hours is associated with an increased likelihood of postoperative pneumonia .

###25012645
OBJECTIVE	To compare the effects of resistance training versus passive physical therapy on bone density in the metastatic bone during radiation therapy ( RT ) as combined treatment in patients with spinal bone metastases .
OBJECTIVE	Secondly , to quantify pathological fractures after combined treatment .
METHODS	In this randomized trial , 60 patients were allocated from September 2011 until March 2013 into one of the two groups : resistance training ( group A ) or passive physical therapy ( group B ) with thirty patients in each group during RT. .
METHODS	Bone density in metastatic and non-metastatic vertebral bone was assessed at baseline , 3 and 6 months after RT. .
RESULTS	Bone density in all metastases increased significantly by 28.3 % ( IQR 11.4-139 .0 ) and 80.3 % ( IQR 32.6-250 .6 ) after 3 and 6 months in group A ( both p < 0.01 ) .
RESULTS	The bone density in group A was significantly increased compared to control group after 3 and 6months ( both p < 0.01 , median 59.7 ; IQR 21.1-98 .3 and median 62.9 ; IQR -9.7 to 161.7 ) .
RESULTS	The bone density data in group B showed no significant increase over the course of time ( p = 0.289 , median 5.5 , IQR 0.0-62 .2 and p = 0.057 , median 52.1 , IQR 0.0-162 .7 ) .
RESULTS	23.3 % of the patients in group A and 30.0 % of the patients in group B had pathological fractures , no fracture was assigned to intervention , and no difference between groups after 3 and 6 months was observed ( p = 0.592 and p = 0.604 ) .
CONCLUSIONS	Our trial demonstrated that resistance training concomitant to RT can improve bone density in spinal bone metastases .
CONCLUSIONS	This combined treatment is effective , practicable , and without side effects for patients .
CONCLUSIONS	Importantly , the pathological fracture rate in the intervention group was not increased .
CONCLUSIONS	The results offer a rationale for future large controlled investigations to confirm these findings .
BACKGROUND	Clinical trial identifier NCT01409720 .

###25470078
BACKGROUND	Female sexual dysfunction ( FSD ) is a common problem that may be encountered in the interruption of normal sexual functioning in the sexual response cycle .
BACKGROUND	Women with a pelvic floor disorder who scored low on the Female Sexual Function Index ( FSFI ) showed an improvement in their sexual life following treatment by vaginal electrical stimulation ( VES ) .
OBJECTIVE	The aim of this trial was to evaluate the effectiveness of VES in women with FSD without a predominant pelvic floor disorder or urinary incontinence .
METHODS	Forty-two women with FSD were randomly allocated to VES and placebo groups .
METHODS	Pelvic floor muscle ( PFM ) assessment and the FSFI questionnaire were performed at baseline and after the completion of sessions .
METHODS	VES treatment was administered using a vaginal probe .
METHODS	The probe was inserted , and a medium-frequency ( 50Hz ) alternating current was administered for a duty cycle of 5 seconds on followed by a 5-second rest .
METHODS	Primary outcome measure was the improvement in FSFI score .
METHODS	PFM assessments were performed according to the PERFECT scheme .
RESULTS	Total FSFI scores improved significantly in both the VES group and the control group .
RESULTS	Results show that in the VES group , there was an improvement in total score and FSFI domains that improved including arousal , desire , orgasm , and satisfaction .
RESULTS	Similarly , control group domains that improved were desire , arousal , and orgasm .
RESULTS	But there was no significant increase in satisfaction scores in the placebo group .
RESULTS	No significant changes in pain or lubrication domains were seen in either group .
RESULTS	Power , endurance , fast contractions , and repetitions were significantly improved in the VES group .
CONCLUSIONS	The lack of significant differences between the placebo and VES groups , except the satisfaction domain , puts into question the effectiveness of electrical stimulation as a monotherapy in treating primary FSD without pelvic floor disorder .

###24284272
BACKGROUND	Muscle fatigue of the trunk extensor musculature plays a considerable role in chronic low back pain ( LBP ) .
BACKGROUND	The underlying physiology of fatigue is complex and not fully understood .
BACKGROUND	The Kinesio Taping ( KT ) supports damaged structures while allowing mobility and at the same time may influence some of the mechanisms associated with muscle fatigue such as blood flow and proprioception .
OBJECTIVE	The aim of this study is to determine the influence of KT on the resistance to fatigue of the lumbar extensor musculature in a sample of young healthy subjects .
METHODS	A randomized , controlled , doubled-blinded clinical trial was conducted .
METHODS	Ninety nine healthy subjects were randomized in to the three arms of the study Kinesio Tape ( KT ) , placebo ( P ) and control ( C ) .
METHODS	Directly after application of KT we measured lumbar extensor musculature endurance with the Biering-Sorensen test .
METHODS	Subjects and researchers were blinded to the intervention .
METHODS	Time achieved ( seconds ) was compared between groups with one-way ANOVA with confidence intervals of 95 % .
RESULTS	There were significant differences between the time achieved in the KT group versus the control group ( p < 0.05 ) .
RESULTS	The placebo group performed better than the control group but worse than the KT group , these were not significant in either case .
CONCLUSIONS	KT appears to improve the time to failure of the extensor muscle of the trunk obtained using the Biering-Sorensen test .
CONCLUSIONS	These findings suggest that KT influences processes that lead to muscle fatigue and that KT could be effective in the management of LBP .

###24577773
OBJECTIVE	To investigate the influence of different pressures of CO2 pneumoperitioneum on pathomorphism and function of intestines following laparoscopic gastrectomy ( LG ) .
METHODS	Forty-eight gastric cancer patients were prospectively enrolled in the study .
METHODS	Among them , 36 patients scheduled for elective LG were randomly assigned to low pressure group ( LP ) , middle pressure ( MP ) , and high pressure group ( HP ) with 12 cases in each group .
METHODS	The CO2 pneumoperitoneum pressure was maintained at 8-10 mmhg in LP , 11-13 mmhg in MP , and 14-16 mmhg in HP .
METHODS	The control group was open gastrectomy group ( OG ) in 12 cases .
METHODS	The intestinal pathomorphism and level of plasma D-lactic acid before , during and after operation , and postoperative intestinal function of four groups were examined and compared .
RESULTS	There were no statistical differences in preoperative data among the four groups ( all P > 0.05 ) .
RESULTS	LG group was associated with a lower rate of surgical complications than OG ( 8.3 % vs. 41.7 % , P < 0.05 ) .
RESULTS	No obvious damage of intestinal mucosa was found in OG group .
RESULTS	Damage degree of intestinal mucosa after operation in LP , MP and HP groups was 0-1 , 1-2 , and 2-3 respectively .
RESULTS	There was significant change in intestinal pathomorphism after operation in both HP and MP groups .
RESULTS	The levels of D-lactic acid before operation were not significantly different among all the four groups , but increased significantly in each group after operation ( all P < 0.05 ) .
RESULTS	HP group had the highest level of plasma D-lactic acid and presented with delayed bowel sound return ( 4.5 d ) , time to first flatus ( 5.4 d ) , and intake ( 6.0 d ) as compared to the other 3 groups ( all P < 0.05 ) .
CONCLUSIONS	Laparoscopic radical gastrectomy is safe and minimally invasive .
CONCLUSIONS	Higher pneumoperitoneal pressure is harmful to the recovery of intestinal mucosa and function .
CONCLUSIONS	Therefore the pneumoperitioneum pressure should be maintained as low as possible under clear visualization during operation .

###24793714
OBJECTIVE	To determine the effectiveness of a short educational video and simulation on improvement of ultrasound ( US ) image acquisition and interpretation skills .
METHODS	Prospective , randomized study .
METHODS	University medical center .
METHODS	28 anesthesia residents and community anesthesiologists with varied ultrasound experience were randomized to teaching video with interactive simulation or sham video groups .
METHODS	Participants were assessed preintervention and postintervention on their ability to identify the sciatic nerve and other anatomic structures on static US images , as well as their ability to locate the sciatic nerve with US on live models .
RESULTS	Pretest written test scores correlated with reported US block experience ( Kendall tau rank r = 0.47 ) and with live US scanning scores ( r = 0.64 ) .
RESULTS	The teaching video and simulation significantly improved scores on the written examination ( P < 0.001 ) ; however , they did not significantly improve live US scanning skills .
CONCLUSIONS	A short educational video with interactive simulation significantly improved knowledge of US anatomy , but failed to improve hands-on performance of US scanning to localize the nerve .

###24294709
OBJECTIVE	To compare the rate of glove perforations and surgeon satisfaction when utilizing blunt surgical needles compared to conventional sharp surgical needles .
METHODS	Patients undergoing Caesarean delivery were randomly assigned to the use of blunt or sharp surgical suture needles .
METHODS	Surgical team members reported any known needlesticks or perforations of gloves and the primary surgeon completed a survey to gauge their satisfaction with the needles .
METHODS	Glove perforation was assessed by suspending gloves and filling with water .
METHODS	The chi-square test was used to assess categorical variables and the Mann-Whitney U-test was used to assess ordinal data .
RESULTS	A total 240 patients were enrolled into the study .
RESULTS	There was no statistically significant difference in the rate of glove perforation per case between groups assigned to sharp ( 24 % ) or blunt surgical needles ( 26 % ) .
RESULTS	( RR 1.05 , 95 % CI 0.68-1 .63 ) .
RESULTS	There were significant differences in the surgeon satisfaction surveys , with surgeons in the sharp needle group being more satisfied with the tissue penetration of the needle ( p < .001 ) , needle integrity ( p = .01 ) , force to penetrate tissue ( p < .001 ) and control of bleeding at the needle insertion site ( p = .001 ) .
RESULTS	Surveys from surgeons in the blunt needle group showed a statistically significant improvement in the perceived safety profile of the blunt needles ( p < .001 ) CONCLUSIONS : There was no significant difference in the rate of glove perforation between blunt and sharp surgical needles during Caesarean delivery .
RESULTS	Overall surgeons were more satisfied with the sharp surgical needles .

###26241254
OBJECTIVE	To estimate the effect of oral midazolam on patient pain and anxiety perception during first-trimester surgical abortion .
METHODS	Between May and December 2013 , we conducted a randomized , double-blind , placebo-controlled trial .
METHODS	Patients between 6 0/7 and 10 6/7 weeks of gestation received 10 mg oral midazolam or placebo 30-60 minutes before surgical abortion .
METHODS	All patients received ibuprofen and a paracervical block .
METHODS	We powered the study ( power = 80 % ; significance level = .025 ) to detect a 15-mm difference in our two a priori primary outcomes of pain and anxiety with uterine aspiration on a 100-mm visual analog scale .
METHODS	Secondary outcomes were pain and anxiety at additional time points , memory , satisfaction , side effects , and adverse events .
RESULTS	Demographics were similar between groups ( placebo = 62 , midazolam = 62 ) .
RESULTS	Compared with those randomized to placebo , patients who received midazolam had significantly less anxiety preoperatively ( room entry : 51.4 mm compared with 34.5 mm , P < .001 ; positioning : 56.6 mm compared with 45.4 mm , P = .02 ) .
RESULTS	There was no difference in pain ( P = .28 ) or anxiety ( P = .14 ) during uterine aspiration or at other procedural time points .
RESULTS	A significantly greater number of patients in the midazolam group reported partial amnesia ( 31/61 compared with 16/61 , P = .005 ) and dizziness ( 30/61 compared with 18/61 , P = .03 ) .
RESULTS	Controlling for baseline differences , patients who received midazolam reported more postoperative sleepiness ( P < .001 ) and less postoperative nausea ( P = .004 ) .
RESULTS	There was no difference in overall satisfaction ( P = .88 ) .
CONCLUSIONS	Although oral midazolam reduces preprocedural anxiety , it does not reduce pain or anxiety with uterine aspiration during first-trimester surgical abortions .
BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT01830881 .
METHODS	I.

###24280956
OBJECTIVE	To determine whether the use of plasma rich in growth factors accelerates healing of the donor site in bone-tendon-bone anterior cruciate ligament ( ACL ) reconstruction ( patellar graft ) .
OBJECTIVE	The use of the patellar graft presents post-operative problems such as anterior knee pain , which limits its use and leads to preference being taken for alternative grafts .
METHODS	A double-blind , randomized , clinical trial was performed comparing two groups of patients who underwent ACL reconstruction using patellar tendon graft and comparing the use of plasma rich in growth factors at the donor site after graft harvest in terms of local regeneration by ultrasound assessment .
RESULTS	The plasma rich in growth factors group shows earlier donor site regeneration in comparison with the control group ( 2months earlier ) , with significant differences in the first 4months of the follow-up .
CONCLUSIONS	The application of plasma rich in growth factors shows accelerated tissue regeneration processes with respect to the control group .
CONCLUSIONS	This fact , together with the previously published with similar conclusions , can create a knowledge basis in order to set out new recovery guidelines following ACL reconstruction .
METHODS	Therapeutic study , Level I.

###24997093
OBJECTIVE	Specific immunotherapy is the only treatment for the underlying allergic disease in patients with respiratory allergies .
OBJECTIVE	The primary objective of this trial was to evaluate the efficacy and safety of two maintenance doses of immunologically enhanced , standardised quality ( SQ + ) grass subcutaneous immunotherapy ( SCIT ) [ 4,000 SQ + and 15,000 SQ + ; AVANZ ( ) Phleum pratense ( ALK ) ] compared with placebo .
METHODS	This was a randomised , double-blind , placebo-controlled , phase II/III trial .
METHODS	The primary evaluation was based on the combined rhinoconjunctivitis score during the entire grass pollen season .
METHODS	Adult subjects with grass pollen-induced allergic rhinoconjunctivitis interfering with usual activities or sleep despite symptomatic medication use , were enrolled .
RESULTS	Four hundred and fifty subjects were randomised to receive either 4,000 SQ + ( n = 150 ) , 15,000 SQ + ( n = 152 ) or placebo ( n = 148 ) .
RESULTS	The average grass pollen exposure was 27 grains/m ( 3 ) / day .
RESULTS	No statistically significant differences between the active groups and the placebo group were found for clinical endpoints ( p > 0.05 ) .
RESULTS	Highly statistically significant ( p < 0.001 ) increases in IgG4 and IgE-blocking factor were found for both active groups versus placebo .
RESULTS	The most frequently reported adverse events were mild-to-moderate local injection-site reactions ; events were generally more frequent with 15,000 SQ + than with 4,000 SQ + and placebo .
RESULTS	The most common adverse events leading to premature discontinuation from the trial were anaphylactic reactions ( one subject from the placebo group and five subjects from the 15,000 SQ + group ) .
CONCLUSIONS	The inconclusive results were most probably influenced by a very low grass pollen season .
CONCLUSIONS	Other factors such as the extent of the pre-seasonal treatment could potentially have contributed .
CONCLUSIONS	The tolerability profile was acceptable for further development .

###24658878
OBJECTIVE	Pacing strategies have been reported to occur during continuous cyclical exercises .
OBJECTIVE	However , currently no studies have examined if pacing takes place during repeated maximal voluntary muscle contractions ( MVCs ) .
OBJECTIVE	Accordingly , the purpose of this study was to examine if informing subjects on the number of MVCs they would perform would affect force and root mean squared electromyography ( EMG ) , during similar fatiguing protocols .
METHODS	Thirty well-trained male subjects completed three fatiguing protocols in a randomized order .
METHODS	In the control condition participants were informed they would perform 12 MVCs , and then completed all 12 .
METHODS	In the unknown condition they were not told how many MVCs they would perform , but were stopped after 12 .
METHODS	Lastly , in the deception condition they were initially told they would perform only 6 MVCs , but after the 6 contractions they were asked to perform a few more repetitions and were stopped after 12 .
RESULTS	Compared to the unknown condition , subjects demonstrated greater forces ( p < 0.05 , ES = 0.35-1 .14 , 2-7 .5 % ) and biceps EMG ( p < 0.05 , ES = 0.6 , 6 % ) in the deception condition during the first six MVCs .
RESULTS	Additionally , under all conditions subjects applied greater forces in the last repetition ( # 12 ) relative to the previous one ( # 11 ) ( p < 0.06 , ES = 0.36-0 .5 , 2.8-3 .8 % ) .
CONCLUSIONS	The anticipation of performing a certain number of MVCs led the subjects to utilize different pacing strategies .
CONCLUSIONS	The results also question the assumption that subjects followed the instruction to exert maximal effort during repeated MVCs .

###25049001
OBJECTIVE	To examine the concurrent and predictive associations between the number of steps taken per day and clinical outcomes in patients with fibromyalgia ( FM ) .
METHODS	A total of 199 adults with FM ( mean age 46.1 years , 95 % women ) who were enrolled in a randomized clinical trial wore a hip-mounted accelerometer for 1 week and completed self-report measures of physical function ( Fibromyalgia Impact Questionnaire-Physical Impairment [ FIQ-PI ] , Short Form 36 [ SF-36 ] health survey physical component score [ PCS ] , pain intensity and interference ( Brief Pain Inventory [ BPI ] ) , and depressive symptoms ( Patient Health Questionnaire-8 [ PHQ-8 ] ) as part of their baseline and followup assessments .
METHODS	Associations of steps per day with self-report clinical measures were evaluated from baseline to week 12 using multivariate regression models adjusted for demographic and baseline covariates .
RESULTS	Study participants were primarily sedentary , averaging 4,019 1,530 steps per day .
RESULTS	Our findings demonstrate a linear relationship between the change in steps per day and improvement in health outcomes for FM .
RESULTS	Incremental increases on the order of 1,000 steps per day were significantly associated with ( and predictive of ) improvements in FIQ-PI , SF-36 PCS , BPI pain interference , and PHQ-8 ( all P < 0.05 ) .
RESULTS	Although higher step counts were associated with lower FIQ and BPI pain intensity scores , these were not statistically significant .
CONCLUSIONS	Step count is an easily obtained and understood objective measure of daily physical activity .
CONCLUSIONS	An exercise prescription that includes recommendations to gradually accumulate at least 5,000 additional steps per day may result in clinically significant improvements in outcomes relevant to patients with FM .
CONCLUSIONS	Future studies are needed to elucidate the dose-response relationship between steps per day and patient outcomes in FM .

###24499425
BACKGROUND	Self-care acupressure might be successful in treating menstrual pain , which is common among young women .
BACKGROUND	There is a need for comparative effectiveness research with stakeholder engagement in all phases seeking to address the needs of decision-makers .
BACKGROUND	Our aim was to design a study on the effectiveness of additional self-care acupressure for menstrual pain comparing usual care alone using different methods of stakeholder engagement .
METHODS	The study was designed using multiple mixed methods for stakeholder engagement .
METHODS	Based on the results of a survey and focus group discussion , a stakeholder advisory group developed the study design .
RESULTS	Stakeholder engagement resulted in a two-arm pragmatic randomized trial .
RESULTS	Two hundred and twenty women aged 18 to 25 years with menstrual pain will be included in the study .
RESULTS	Outcome measurement will be done using electronic questionnaires provided by a study specific mobile application ( App ) .
RESULTS	Primary outcome will be the mean pain intensity at the days of pain during the third menstruation after therapy start .
CONCLUSIONS	Stakeholder engagement helped to develop a study design that better serves the needs of decision makers , including an App as a modern tool for both intervention and data collection in a young target group .
BACKGROUND	Clinicaltrials.gov identifier http://NCT01582724 .

###24709512
OBJECTIVE	The aim of the present randomized controlled trial was to determine the safety and efficacy of injectable demineralized bone matrix ( DBM ) gel combined with recombinant human bone morphogenetic protein-2 ( rhBMP-2 ) on alveolar ridge preservation after tooth extraction .
METHODS	A total of 69 patients were randomly assigned to either a test group ( n = 35 ) or a control group ( n = 34 ) .
METHODS	In the test group , DBM , together with rhBMP-2 ( 0.05 mg/mL ; rhBMP-2 / DBM ) was transplanted into the extraction sockets .
METHODS	The control group received DBM alone .
METHODS	The safety of rhBMP-2 / DBM was evaluated by oral examination , serum chemistry , and hematologic examination .
METHODS	The radiographic changes in alveolar bone height and width were measured using computed tomography scans performed immediately after transplant and again 3 months thereafter .
RESULTS	Healing was uneventful in all subjects , with no anticipated adverse events and no clinically significant changes in the serum chemistry and hematologic findings .
RESULTS	No meaningful immune response was found among the study groups .
RESULTS	No significant difference was found in the radiographic changes of alveolar bone height and width ( P > .05 ) .
CONCLUSIONS	This new injectable biomaterial can be used easily and safely in clinical applications .

###24561645
BACKGROUND	Sharing information with the team is critical in developing a shared mental model in an emergency , and fundamental to effective teamwork .
BACKGROUND	We developed a structured call-out tool , encapsulated in the acronym ` SNAPPI ' : Stop ; Notify ; Assessment ; Plan ; Priorities ; Invite ideas .
BACKGROUND	We explored whether a video-based intervention could improve structured call-outs during simulated crises and if this would improve information sharing and medical management .
METHODS	In a simulation-based randomized , blinded study , we evaluated the effect of the video-intervention teaching SNAPPI on scores for SNAPPI , information sharing , and medical management using baseline and follow-up crisis simulations .
METHODS	We assessed information sharing using a probe technique where nurses and technicians received unique , clinically relevant information probes before the simulation .
METHODS	Shared knowledge of probes was measured in a written , post-simulation test .
METHODS	We also scored sharing of diagnostic options with the team and medical management .
RESULTS	Anaesthetists ' scores for SNAPPI were significantly improved , as was the number of diagnostic options they shared .
RESULTS	We found a non-significant trend to improve information-probe sharing and medical management in the intervention group , and across all simulations , a significant correlation between SNAPPI and information-probe sharing .
RESULTS	Of note , only 27 % of the clinically relevant information about the patient provided to the nurse and technician in the pre-simulation information probes was subsequently learnt by the anaesthetist .
CONCLUSIONS	We developed a structured communication tool , SNAPPI , to improve information sharing between anaesthetists and their team , taught it using a video-based intervention , and provide initial evidence to support its value for improving communication in a crisis .

###25290151
BACKGROUND	Persistent pain after inguinal herniorrhaphy is a disabling condition with a lack of evidence-based pharmacological treatment options .
BACKGROUND	This randomized placebo-controlled trial investigated the efficacy of a capsaicin 8 % cutaneous patch in the treatment of severe persistent inguinal postherniorrhaphy pain .
METHODS	Forty-six patients with persistent inguinal postherniorrhaphy pain were randomized to receive either a capsaicin 8 % patch or a placebo patch .
METHODS	Pain intensity ( Numerical Rating Scale [ NRS 0-10 ] ) was evaluated under standardized conditions ( at rest , during movement , and during pressure ) at baseline and at 1 , 2 and 3 months after patch application .
METHODS	Skin punch biopsies for intraepidermal nerve fiber density ( IENFD ) measurements were taken at baseline and 1 month after patch application .
METHODS	Quantitative sensory testing was performed at baseline and at 1 , 2 , and 3 months after patch application .
METHODS	The primary outcome was comparisons of summed pain intensity differences ( SPIDs ) between capsaicin and placebo treatments at 1 , 2 and 3 months after patch application ( significance level P < 0.01 ) .
RESULTS	The maximum difference in SPID , between capsaicin and placebo treatments , was observed at 1 month after patch application , but the pain reduction was not significant ( NRS , mean difference [ 95 % CI ] : 5.0 [ 0.09 to 9.9 ] ; P = 0.046 ) .
RESULTS	No differences in SPID between treatments were observed at 2 and 3 months after patch application .
RESULTS	Changes in IENFD on the pain side , from baseline to 1 month after patch application , did not differ between capsaicin and placebo treatment : 1.9 [ -0.1 to 3.9 ] and 0.6 [ -1.2 to 2.5 ] fibers/mm , respectively ( P = 0.32 ) .
RESULTS	No significant changes in sensory function , sleep quality or psychological factors were associated with capsaicin patch treatment .
CONCLUSIONS	The study did not demonstrate significant differences in pain relief between capsaicin and placebo treatment , although a trend toward pain improvement in capsaicin treated patients was observed 1 month after patch application .
BACKGROUND	Clinicaltrialsregister.eu 2012-001540-22 ClinicalTrials.gov NCT01699854 .

###24356622
BACKGROUND	The study 20050181 demonstrated significant improvements in progression-free survival ( PFS ) , objective response , and a nonsignificant trend toward increased overall survival ( OS ) with panitumumab-FOLFIRI versus FOLFIRI alone for second-line wild-type ( WT ) KRAS metastatic colorectal cancer ( mCRC ) .
BACKGROUND	Updated long-term data from a prespecified descriptive analysis are reported .
METHODS	Patients receiving one prior mCRC treatment were randomly assigned ( 1:1 ) to panitumumab ( 6.0 mg/kg ) - FOLFIRI versus FOLFIRI every 2 weeks .
METHODS	Co-primary end points ( PFS and OS ) were prospectively analyzed by tumor KRAS status .
RESULTS	One thousand one hundred and eighty-six patients were randomly assigned .
RESULTS	In patients with WT KRAS tumors , panitumumab-FOLFIRI significantly improved PFS versus FOLFIRI [ median 6.7 versus 4.9 months ; hazard ratio ( HR ) 0.82 [ 95 % confidence interval ( CI ) 0.69 , 0.97 ] ; P = 0.023 ] .
RESULTS	A trend toward longer OS was observed ( median 14.5 versus 12.5 months ; HR 0.92 [ 95 % CI 0.78 , 1.10 ] ; P = 0.37 ) .
RESULTS	Response rates improved from 10 % to 36 % ( P < 0.0001 ) .
RESULTS	From post hoc analyses in patients receiving prior oxaliplatin-bevacizumab , panitumumab-FOLFIRI improved PFS ( median 6.4 versus 3.7 months ; HR 0.58 [ 95 % CI 0.37 , 0.90 ] ; P = 0.014 ) .
RESULTS	PFS and OS appeared longer for worst-grade skin toxicity of 2-4 , versus 0-1 or FOLFIRI .
RESULTS	Safety results were as previously reported and consistent with the known toxicities with anti-epidermal growth factor receptor therapy .
CONCLUSIONS	These data confirm the primary efficacy and safety findings of this trial and support panitumumab-FOLFIRI as a second-line treatment of WT KRAS mCRC .

###24256500
BACKGROUND	There is some evidence that individual-level job loss can lead to greater alcohol consumption and problems .
BACKGROUND	While other forms of economic loss were common during the recent recession , these are rarely investigated in studies of macroeconomic decline .
BACKGROUND	This study examined the relationship between types of economic loss in the 2008 to 2009 recession and alcohol outcomes , and whether this varied by gender and age .
METHODS	Data are from the 2009 to 2010 U.S. National Alcohol Survey ( N = 5,382 ) .
METHODS	We used multivariable regression to estimate associations between economic loss and alcohol volume , monthly drunkenness , negative drinking consequences , and alcohol dependence in the overall sample and within gender and age groups ( 18 to 29 , 30 to 49 , 50 + ) , controlling for demographic and alcohol history covariates .
RESULTS	In the overall sample , severe economic loss ( job or housing loss ) was positively associated with negative drinking consequences , alcohol dependence , and ( marginally ) drunkenness , whereas moderate loss ( loss of retirement savings , reduced work hours/wages , or trouble paying the rent/mortgage ) was unassociated with alcohol outcomes .
RESULTS	Important gender and age differences were observed .
RESULTS	Women reporting retirement loss , reduced hours/wages , and job loss consumed 41 to 70 % more alcohol than women unaffected by the recession , and men who experienced job loss and housing problems had increased risk for drunkenness , drinking consequences , and dependence .
RESULTS	Middle-aged Americans affected by partial or complete job loss and housing problems also had greater risk of drunkenness and alcohol-related problems , and older adults who lost retirement savings drank 42 % more alcohol than their peers unaffected by the recession .
RESULTS	With the exception of negative drinking consequences , young adult alcohol outcomes were largely unrelated to recessionary loss .
CONCLUSIONS	This study highlights the adverse effects of recession-induced economic losses on alcohol use and problems in demographic subgroups .
CONCLUSIONS	As men and middle-aged Americans were at risk for multiple , adverse alcohol outcomes , these groups may warrant special alcohol screening and intervention efforts in future macroeconomic crises .

###25413652
BACKGROUND	Estimated effects of breast-feeding on childhood health vary between studies , possibly due to confounding by baseline maternal and child characteristics .
BACKGROUND	Possible time-dependent confounding has received little consideration .
BACKGROUND	Our aim was to evaluate the impact of such confounding .
METHODS	We estimated the relationship between cumulative exclusive breast-feeding up to 6 months and wheezing , rash and body mass index ( BMI ) at 12 months [ in the Whistler cohort ( n = 494 ) and PROBIT ( n = 11,463 ) ] , and wheezing , rash , asthma , hay fever , eczema , allergy and BMI at age 6.5 years ( PROBIT ) .
METHODS	We adjusted for time-dependent confounding by weight , length , rash , respiratory illness and day care attendance using marginal structural models ( MSMs ) .
RESULTS	Weight and day care attendance appeared potential time-dependent confounders , since these predicted breast-feeding status and were influenced by previous breast-feeding .
RESULTS	However , adjustment for time-dependent confounders did not markedly change the estimated associations .
RESULTS	For example , in PROBIT the adjusted increase in BMI at 12 months per 1-month increase in exclusive breast-feeding was 0.04 ( 95 % CI -0.09 to 0.01 ) using logistic regression and -0.06 ( 95 % CI -0.11 to -0.01 ) using MSM .
RESULTS	In Whistler , these estimates were each -0.05 ( 95 % CI -0.10 to 0.00 ) .
CONCLUSIONS	In two cohort studies , there was little evidence of time-dependent confounding by weight , length , rash , respiratory illness or day care attendance of the effects of breast-feeding on early childhood health .

###25504268
OBJECTIVE	Cryoballoon isolation of the pulmonary veins ( PVI ) is an effective and safe method in the treatment of patients with paroxysmal atrial fibrillation ( PAF ) .
OBJECTIVE	The circular mapping catheter Achieve ( Medtronic Inc. , Minneapolis , USA ) can be introduced into the pulmonary vein ( PV ) through the inner lumen of the balloon catheter , allowing online mapping of the PV electrograms during ablation .
OBJECTIVE	We prospectively compared the accuracy of this catheter in both available sizes to a standard circular mapping catheter ( SCMC ) in order to determine bidirectional PV block .
METHODS	Patients with symptomatic PAF underwent cryoballoon ablation using either the Achieve 15-mm catheter ( group 1 , 15 patients ) or the Achieve 20 mm ( group 2 , 15 patients ) .
METHODS	PV potentials were recorded using Achieve before , during , and after ablation , and exit block was obtained by pacing from inside the PV .
METHODS	Accuracy of PV potential detection was controlled by a SCMC before and after ablation .
RESULTS	Rate of PV which could be isolated exclusively using the Achieve as guidewire was 98 % ( 59/60 ) in group 1 and 93 % ( 57/60 ) in group 2 .
RESULTS	Online signal recording during ablation was possible in 40 and 60 % of PV ( p = 0.037 ) , respectively .
RESULTS	Final Achieve diagnosis was accurate in 55/60 ( 92 % ) of the PVs and 12/15 ( 80 % ) of patients in group 1 and 60/60 ( 100 % ) of PV and 15/15 ( 100 % ) of patients in group 2 .
CONCLUSIONS	Stand-alone mapping using Achieve 15 mm resulted in a significant lack of diagnostic accuracy .
CONCLUSIONS	Achieve 20 mm provided excellent diagnostic accuracy comparable to a SCMC and should be preferentially used .

###25470888
BACKGROUND	The aim of this study was to investigate the effect of magnesium administered before induction on the hemodynamic response and QT dispersion ( QTd ) related with intubation in hypertensive patients and to compare it with lidocaine .
METHODS	Patients with essential hypertension who were under 65 years old , scheduled for elective surgery with a Mallampati score of I-II were included in the study .
METHODS	Patients were randomly divided into three groups ; group M ( n = 20 ) received magnesium sulfate , group L was prescribed lidocaine , and group C ( control group ) received saline .
METHODS	Standard 12-lead ECG readings were taken before the induction of anesthesia and at the first and fifth minutes following intubation .
RESULTS	There were no statistically significant differences between the groups in terms of age , sex and demographic characteristics .
RESULTS	There was no significant difference in the QT interval values before induction and 5 minutes after intubation in all groups .
RESULTS	In group M , QTd values were significantly lower at the first and fifth minutes than before induction .
RESULTS	There were no statistically significant differences in QTd values at different times in group L and group C.
CONCLUSIONS	QTd is not increased during tracheal intubation in hypertensive patients so there is no need for magnesium sulfate for these patients .
CONCLUSIONS	But as QTd has been shown to increase during tracheal intubation for coronary artery disease patients , magnesium sulfate might be useful for those patients although future studies are required to confirm this statement .

###25247320
BACKGROUND	Cervical cancer screening coverage remains insufficient in most countries .
BACKGROUND	Our objective was to assess whether in-home vaginal self-sampling with a dry swab for high-risk human papillomavirus ( HR-HPV ) testing is effective and cost-effective in increasing participation in cervical cancer screening .
METHODS	In March 2012 , 6000 unscreened women aged 30-65 years , living in a French region covered by a screening programme , who had not responded to an initial invitation to have a Pap smear were equally randomised to three groups : ` no intervention ' ; ` recall ' , women received a letter to have a Pap smear ; and ` self-sampling ' , women received a self-sampling kit to return to a centralised virology laboratory for PCR-based HPV testing .
RESULTS	Participation was higher in the ` self-sampling ' than in the ` no intervention ' group ( 22.5 % vs 9.9 % , P < 0.0001 ; OR 2.64 ) and ` recall ' group ( 11.7 % , P < 0.0001 ; OR 2.20 ) .
RESULTS	In the ` self-sampling ' group , 320 used the self-sampling kit ; for 44 of these women with positive HR-HPV test results , 40 had the recommended triage Pap smear .
RESULTS	The ICER per extra screened woman was 77.8 [ euro ] and 63.2 [ euro ] for the ` recall ' and ` self-sampling ' groups , respectively , relative to the ` no intervention ' group .
CONCLUSIONS	Offering an in-home , return-mail kit for vaginal self-sampling with a dry swab is more effective and cost-effective than a recall letter in increasing participation in cervical cancer screening .

###24419823
BACKGROUND	Chronic plantar fasciitis is a common orthopedic condition that can prove difficult to successfully treat .
BACKGROUND	In this study , autologous platelet-rich plasma ( PRP ) , a concentrated bioactive blood component rich in cytokines and growth factors , was compared to traditional cortisone injection in the treatment of chronic cases of plantar fasciitis resistant to traditional nonoperative management .
METHODS	Forty patients ( 23 females and 17 males ) with unilateral chronic plantar fasciitis that did not respond to a minimum of 4 months of standardized traditional nonoperative treatment modalities were prospectively randomized and treated with either a single ultrasound guided injection of 3 cc PRP or 40 mg DepoMedrol cortisone .
METHODS	American Orthopedic Foot and Ankle Society ( AOFAS ) hindfoot scoring was completed for all patients immediately prior to PRP or cortisone injection ( pretreatment = time 0 ) and at 3 , 6 , 12 , and 24 months following injection treatment .
METHODS	Baseline pretreatment radiographs and MRI studies were obtained in all cases to confirm the diagnosis of plantar fasciitis .
RESULTS	The cortisone group had a pretreatment average AOFAS score of 52 , which initially improved to 81 at 3 months posttreatment but decreased to 74 at 6 months , then dropped to near baseline levels of 58 at 12 months , and continued to decline to a final score of 56 at 24 months .
RESULTS	In contrast , the PRP group started with an average pretreatment AOFAS score of 37 , which increased to 95 at 3 months , remained elevated at 94 at 6 and 12 months , and had a final score of 92 at 24 months .
CONCLUSIONS	PRP was more effective and durable than cortisone injection for the treatment of chronic recalcitrant cases of plantar fasciitis .
METHODS	Level I , prospective randomized comparative series .

###24474088
OBJECTIVE	The optimal design for a cemented femoral stem remains a matter of debate .
OBJECTIVE	Over time , the shape , surface finish and collar have all been modified in various ways .
OBJECTIVE	A clear consensus has not yet emerged regarding the relative merits of even the most basic design features of the stem .
OBJECTIVE	We undertook a prospective randomised trial comparing surface finish and the effect of a collar on cemented femoral component subsidence , survivorship and clinical function .
METHODS	One hundred and sixty three primary total hip replacement patients were recruited prospectively and randomised to one of four groups to receive a cemented femoral stem with either a matt or polished finish , and with or without a collar .
RESULTS	At two years , although there was a trend for increased subsidence in the matt collarless group , this was not statistically significant ( p = 0.18 ) .
RESULTS	At a mean of 10.1 years follow-up , WOMAC scores for the surviving implants were good , ( Range of means 89-93 ) without significant differences .
RESULTS	Using revision or radiographic loosening as the endpoint , survivorship of the entire cohort was 93 % at 11 yrs , ( CI 87-97 % ) .
RESULTS	There were no significant differences in survivorship between the two groups with polished stems or the two groups with matt stems .
RESULTS	A comparison of the two collarless stems demonstrated a statistically significant difference in survivorship between polished ( 100 % ) and matt ( 88 % ) finishes ( p = 0.02 ) .
CONCLUSIONS	In the presence of a collar , surface finish did not significantly affect survivorship or function .
CONCLUSIONS	Between the two collarless groups a polished surface conferred an improved survivorship .

###24559216
OBJECTIVE	Despite the availability and demonstrated effectiveness of intensive combination treatment strategies ( ICTS ) for early rheumatoid arthritis ( RA ) , a discrepancy seems to exist between theoretical evidence and actual prescription in daily practice .
OBJECTIVE	The purpose of this study was to explore and identify the factors influencing the prescription of ICTS .
METHODS	This study involved rheumatologists and nurses participating in the Care for Rheumatoid Arthritis ( CareRA ) trial , a multicentre randomized controlled trial ( RCT ) comparing different ICTS for early RA with conventional disease-modifying anti-rheumatic drugs ( DMARDs ) plus step-down glucocorticoids ( GCs ) .
METHODS	A qualitative study was carried out using individual semi-structured interviews .
METHODS	Each interview was recorded , transcribed literally , and analysed thematically .
METHODS	In addition , observations at outpatient clinics were used to clarify the interpretation of the results .
RESULTS	We interviewed 26 rheumatologists and six nurses and observed five outpatient visits .
RESULTS	Identified facilitators included available scientific evidence , personal faith in treatment strategy , staff support , and low treatment costs .
RESULTS	Rheumatologists had no doubts about the value of methotrexate ( MTX ) but some questioned the value of combination strategy , others the effectiveness and/or the dosage of individual compounds .
RESULTS	Additional barriers for prescribing ICTS included need for patient education , fear for patients ' preconceptions , concerns about applicability to the individual patient , difficulties with breaking routine , interference with organizational structures and processes , time constraints , and lack of financial support .
CONCLUSIONS	A heterogeneous set of factors highlights the complexity of prescribing ICTS for early RA in daily clinical practice .
CONCLUSIONS	Future improvement strategies should stimulate the facilitators while at the same time addressing the barriers .
CONCLUSIONS	The generalizability of these findings to other health care systems needs further examination .

###25716389
BACKGROUND	Millions of women are afflicted with stress urinary incontinence .
BACKGROUND	Urinary incontinence is mentioned as one of the geriatric syndromes , together with pressure ulcers , functional decline , falls , and low self-esteem .
BACKGROUND	The aim of the present study was to determine the effect of pelvic muscle exercises on urinary incontinency and self - esteem of elderly females with stress urinary incontinency in Shiraz , Iran , 2013 .
METHODS	In this interventional study , 50 old females aged 60-74 years were chosen among the members of Jahandidegan center , and they were asked to sign the informed consent form and complete the demographic questionnaire .
METHODS	Then , Quid questionnaire was used for choosing the type of incontinence in the elderly females .
METHODS	Next , the participants completed the ICIQ and self-esteem questionnaires .
METHODS	Then , they were randomly assigned to case and control groups .
METHODS	Each participant took part in 8 training classes .
METHODS	Finally , the subjects filled the ICIQ and self-esteem questionnaires before and 2 months after the intervention .
RESULTS	The results is shown that after the intervention , ICIQ score has a significant difference between the two groups ( P = 0.001 ) .
RESULTS	Also , after the treatment , self-esteem average scores of studied unit indicated a significant statistical difference in experimental group .
RESULTS	In other words , the training sessions improved the score of self-esteem in the experimental group ( P < 0.001 ) versus control group ( P = 0.08 ) .
CONCLUSIONS	Pelvic muscle exercises were an empowerment mechanism for incontinent women in improving their quality of life and self-esteem , so recommended that such these exercising programs be used in elderly health care centers as a factor to improve health promotion of elderlies ` that are suffering from urinary incontinence .

###24402390
BACKGROUND	Nutritional risk is relatively common in community-dwelling older people .
OBJECTIVE	To objective of this study was to evaluate the effects of individual dietary counseling as part of a Comprehensive Geriatric Assessment on nutritional status among community-dwelling people aged 75 years or older .
METHODS	Data were obtained from a subpopulation of participants in the population-based Geriatric Multidisciplinary Strategy for the Good Care of the Elderly ( GeMS ) intervention study in 2004 to 2007 .
METHODS	In the present study , the population consist 173 persons at risk of malnutrition in the year 2005 in an intervention ( n = 84 ) and control group ( n = 89 ) .
METHODS	Nutritional status , body weight , body mass index , serum albumin were performed at the beginning of the study and at a two-year follow-up .
METHODS	The nutritional screening was performed using the Mini Nutritional Assessment ( MNA ) test .
RESULTS	A increase in MNA scores ( 1.8 95 % confidence interval [ CI ] : 0.7 to 2.0 ) and in serum albumin ( 0.8 g/L , 95 % CI : 0.2 to 0.9 g/L ) were a significant difference between the groups .
CONCLUSIONS	Nutritional intervention , even dietary counseling without nutritional supplements , may improve nutritional status .

###24731384
OBJECTIVE	The purpose of this study was to evaluate whether posterior cruciate ligament reconstruction with the double-bundle ( DB ) technique improved stability of the knee compared with the single-bundle ( SB ) technique .
METHODS	This prospective study included 50 patients who were randomized to undergo posterior cruciate ligament reconstruction by use of tibialis anterior grafts with either the SB technique ( 25 patients ) or DB technique ( 25 patients ) .
METHODS	The group assignment was concealed before allocation with the use of sealed envelopes .
METHODS	Posterior stability was evaluated with the KT-1000 arthrometer ( MEDmetric , San Diego , CA ) , and clinical outcomes were assessed with the Lysholm score , Tegner activity score , and International Knee Documentation Committee score ( both objective and subjective ) .
RESULTS	There were 22 patients in the SB group and 24 patients in the DB group with a minimum follow-up period of 2 years .
RESULTS	No differences were found between the 2 groups regarding patient demographic data and the duration from injury to operation ( P > .05 ) .
RESULTS	The Lysholm score was 88.0 4.2 ( range , 83 to 93 ) in the SB group and 89.8 3.8 ( range , 86 to 95 ) in the DB group , and there was no significant difference between the 2 groups ( P = .447 ) .
RESULTS	The Tegner activity score improved significantly to 6.2 0.9 ( range , 5 to 8 ) in the SB group and 6.8 1.2 ( range , 5 to 9 ) in the DB group .
RESULTS	The side-to-side difference in posterior translation decreased to 4.1 1.3 mm ( range , 5.5 to 2.5 mm ) in the SB group and 2.2 1.3 mm ( range , 4.5 to 2.0 mm ) in the DB group , and there was a significant difference between the 2 groups ( P < .05 ) .
RESULTS	According to the International Knee Documentation Committee ( both objective and subjective ) , the DB group had a better grade distribution ( P < .05 ) and had a statistically higher grade ( 71.6 6.7 ; range , 63 to 80 ) than the SB group ( 65.5 7.8 ; range , 56 to 75 ) ( P < .05 ) .
CONCLUSIONS	Although both techniques resulted in similar patient satisfaction as measured by outcome assessment , the DB procedure significantly improved knee stability .
METHODS	Level II , lesser-quality randomized controlled trial .

###24528783
BACKGROUND	Pedometer-based programs have elicited increased walking behaviors associated with improvements in blood pressure in sedentary/low active postmenopausal women , a population at increased risk of cardiovascular disease .
BACKGROUND	Such programs typically encourage increasing the volume of physical activity with little regard for its intensity .
BACKGROUND	Recent advances in commercially available pedometer technology now permit tracking of both steps/day and time in moderate ( or greater ) intensity physical activity on a daily basis .
BACKGROUND	It is not known whether the dual message to increase steps/day while also increasing time spent at higher intensity walking will elicit additional improvements in blood pressure relative to a message to only focus on increasing steps/day .
BACKGROUND	The purpose of this paper is to present the rationale , study design , and protocols employed in WalkMore , a 3-arm 3-month blinded and randomized controlled trial ( RCT ) designed to compare the effects of two community pedometer-based walking interventions ( reflecting these separate and combined messages ) relative to a control group on blood pressure in sedentary/low active post-menopausal women , a population at increased risk of cardiovascular disease .
METHODS	120 sedentary/low active post-menopausal women ( 45-74years of age ) will be randomly assigned ( computer-generated ) to 1 of 3 groups : A ) 10,000 steps/day ( with no guidance on walking intensity/speed/cadence ; BASIC intervention , n = 50 ) ; B ) 10,000 steps/day and at least 30minutes in moderate intensity ( i.e. , a cadence of at least 100 steps/min ; ENHANCED intervention , n = 50 ) ; or a Control group ( n = 20 ) .
METHODS	An important strength of the study is the strict control and quantification of the pedometer-based physical activity interventions .
METHODS	The primary outcome is systolic blood pressure .
METHODS	Secondary outcomes include diastolic blood pressure , anthropometric measurements , fasting blood glucose and insulin , flow mediated dilation , gait speed , and accelerometer-determined physical activity and sedentary behavior .
CONCLUSIONS	This study can make important contributions to our understanding of the relative benefits that walking volume and/or intensity may have on blood pressure in a population at risk of cardiovascular disease .
BACKGROUND	ClinicalTrials.gov Record NCT01519583 , January 18 , 2012 .

###25270426
BACKGROUND	Cognitive behavioral therapy ( CBT ) and U.S. Food and Drug Administration ( FDA ) - recommended pharmacologic treatments ( RPTs ; pregabalin , duloxetine , and milnacipran ) are effective treatment options for fibromyalgia ( FM ) syndrome and are currently recommended by clinical guidelines .
BACKGROUND	We compared the cost-utility from the healthcare and societal perspectives of CBT versus RPT ( combination of pregabalin + duloxetine ) and usual care ( TAU ) groups in the treatment of FM .
METHODS	The economic evaluation was conducted alongside a 6-month , multicenter , randomized , blinded , parallel group , controlled trial .
METHODS	In total , 168 FM patients from 41 general practices in Zaragoza ( Spain ) were randomized to CBT ( n = 57 ) , RPT ( n = 56 ) , or TAU ( n = 55 ) .
METHODS	The main outcome measures were Quality-Adjusted Life Years ( QALYs , assessed by using the EuroQoL-5D questionnaire ) and improvements in health-related quality of life ( HRQoL , assessed by using EuroQoL-5D visual analogue scale , EQ-VAS ) .
METHODS	The costs of healthcare use were estimated from patient self-reports ( Client Service Receipt Inventory ) .
METHODS	Cost-utility was assessed by using the net-benefit approach and cost-effectiveness acceptability curves ( CEACs ) .
RESULTS	On average , the total costs per patient in the CBT group ( 1,847 ) were significantly lower than those in patients receiving RPT ( 3,664 ) or TAU ( 3,124 ) .
RESULTS	Patients receiving CBT reported a higher quality of life ( QALYs and EQ-VAS scores ) ; the differences between groups were significant only for EQ-VAS .
RESULTS	From a complete case-analysis approach ( base case ) , the point estimates of the cost-effectiveness ratios resulted in dominance for the CBT group in all of the comparisons performed , by using both QALYs and EQ-VAS as outcomes .
RESULTS	These findings were confirmed by bootstrap analyses , net-benefit curves , and CEACs .
RESULTS	Two additional sensitivity analyses ( intention-to-treat analysis and per-protocol analysis ) indicated that the results were robust .
RESULTS	The comparison of RPT with TAU yielded no clear preference for either treatment when using QALYs , although RPT was determined to be more cost-effective than TAU when evaluating EQ-VAS .
CONCLUSIONS	Because of lower costs , CBT is the most cost-effective treatment for adult FM patients .
CONCLUSIONS	Implementation in routine medical care would require policymakers to develop more-widespread public access to trained and experienced therapists in group-based forms of CBT .
BACKGROUND	Current Controlled Trials ISRCTN10804772 .
BACKGROUND	Registered 29 September 2008 .

###25958079
BACKGROUND	Phosphate binders are the cornerstone of hyperphosphatemia management in dialysis patients .
BACKGROUND	Ferric citrate is an iron-based oral phosphate binder that effectively lowers serum phosphorus levels .
METHODS	52-week , open-label , phase 3 , randomized , controlled trial for safety-profile assessment .
METHODS	Maintenance dialysis patients with serum phosphorus levels 6.0 mg/dL after washout of prior phosphate binders .
METHODS	2:1 randomization to ferric citrate or active control ( sevelamer carbonate and/or calcium acetate ) .
RESULTS	Changes in mineral bone disease , protein-energy wasting/inflammation , and occurrence of adverse events after 1 year .
METHODS	Serum calcium , intact parathyroid hormone , phosphorus , aluminum , white blood cell count , percentage of lymphocytes , serum urea nitrogen , and bicarbonate .
RESULTS	There were 292 participants randomly assigned to ferric citrate , and 149 , to active control .
RESULTS	Groups were well matched .
RESULTS	For mean changes from baseline , phosphorus levels decreased similarly in the ferric citrate and active control groups ( -2.041.99 [ SD ] vs -2.182.25 mg/dL , respectively ; P = 0.9 ) ; serum calcium levels increased similarly in the ferric citrate and active control groups ( 0.220.90 vs 0.310.95 mg/dL ; P = 0.2 ) .
RESULTS	Hypercalcemia occurred in 4 participants receiving calcium acetate .
RESULTS	Parathyroid hormone levels decreased similarly in the ferric citrate and active control groups ( -167.1399.8 vs -152.7392.1 pg/mL ; P = 0.8 ) .
RESULTS	Serum albumin , bicarbonate , serum urea nitrogen , white blood cell count and percentage of lymphocytes , and aluminum values were similar between ferric citrate and active control .
RESULTS	Total and low-density lipoprotein cholesterol levels were lower in participants receiving sevelamer than those receiving ferric citrate and calcium acetate .
RESULTS	Fewer participants randomly assigned to ferric citrate had serious adverse events compared with active control .
CONCLUSIONS	Open-label study , few peritoneal dialysis patients .
CONCLUSIONS	Ferric citrate was associated with similar phosphorus control compared to active control , with similar effects on markers of bone and mineral metabolism in dialysis patients .
CONCLUSIONS	There was no evidence of protein-energy wasting/inflammation or aluminum toxicity , and fewer participants randomly assigned to ferric citrate had serious adverse events .
CONCLUSIONS	Ferric citrate is an effective phosphate binder with a safety profile comparable to sevelamer and calcium acetate .

###24869931
BACKGROUND	We report detailed safety analyses by geographic region from the phase III study CLEOPATRA with pertuzumab , trastuzumab , and docetaxel in patients with human epidermal growth factor receptor 2 ( HER2 ) - positive first-line metastatic breast cancer .
METHODS	Patients received pertuzumab/placebo at 840 mg in cycle 1 and 420 mg in subsequent cycles , and trastuzumab at 8 mg/kg in cycle 1 and 6 mg/kg in subsequent cycles ; docetaxel was initiated at 75 mg/m ( 2 ) .
METHODS	All study drugs were given intravenously , 3 times weekly .
RESULTS	Docetaxel dose reductions below 75 mg/m ( 2 ) were more common in patients from Asia ( 47.0 % ) than other regions ( 13.4 % ) ; docetaxel dose escalations to 100 mg/m ( 2 ) were less frequent in Asia ( 2.4 % ) than other regions ( 18.7 % ) .
RESULTS	Rates of edema ( 26.1 % and 5.4 % for Asia and other regions , respectively ) , myalgia ( 42.3 % , 14.7 % ) , nail disorder ( 39.9 % , 15.1 % ) , febrile neutropenia ( 18.6 % , 7.1 % ) , upper respiratory tract infection ( 25.7 % , 10.2 % ) , decreased appetite ( 47.0 % , 19.1 % ) , and rash ( 44.3 % , 22.0 % ) were at least twice as high in Asia as in other regions .
RESULTS	Adverse events did not result in a reduction in the median number of study treatment cycles administered in patients from Asia .
RESULTS	Efficacy analyses per region showed hazard ratios similar to those of the whole intention-to-treat ( ITT ) population for progression-free survival ( ITT : 0.63 ; Asia : 0.68 ; other regions : 0.61 ) and overall survival ( ITT : 0.66 ; Asia : 0.64 ; other regions : 0.66 ) .
CONCLUSIONS	Despite a higher proportion of docetaxel dose reductions in patients from Asia , survival benefits were comparable between regions .
CONCLUSIONS	The benefit-risk profile of pertuzumab , trastuzumab , and docetaxel supports this regimen as the first-line therapy for patients with HER2-positive metastatic breast cancer from all geographic regions .

###25238424
OBJECTIVE	The purpose of this study was to assess the feasibility of an endoscopic , optical-fiber-based , laser delivery system ( LDS ) developed to perform sole-therapy transmyocardial revascularization ( TMR ) in a totally endoscopic , robotically assisted operation .
METHODS	Forty-two patients were enrolled in a multicenter , prospective , single-arm clinical trial conducted at four US centers between 2005 and 2007 .
METHODS	Transmyocardial revascularization was performed completely endoscopically with robotic assistance , introducing the Holmium : Yttrium aluminum garnet ( YAG ) LDS via a 5-mm port .
METHODS	Completion of the operation endoscopically defined procedural success .
METHODS	Clinical data were recorded before , during , and at least 30 days after the procedure .
RESULTS	All patients had Canadian Cardiovascular Score angina class IV at baseline .
RESULTS	The mean ejection fraction was 49 % ( range [ R ] , 28-71 ) , the mean age was 59.1 years ( R , 36-80 ) , 71 % ( 30/42 ) were men , 86 % ( 36/42 ) underwent previous coronary artery bypass grafting surgery , and 76 % ( 32/42 ) underwent prior coronary stenting .
RESULTS	Procedural success was accomplished in 93 % ( 39/42 ) .
RESULTS	For the procedural successes , the mean number of TMR channels was 32 ( R , 16-50 ) , the median operative time was 88 minutes ( R , 48-250 minutes ) , and the median length of stay postoperatively was 2.5 days ( R , 1-10 ) .
RESULTS	There was no operative or 30-day mortality , and no patient received any transfusion .
RESULTS	At 30 days , freedom from major adverse cardiac events was 95 % ( two patients had transient congestive heart failure ) .
RESULTS	At the median 6-month follow-up ( single-center data , n = 12 ) , the mean ( SD ) Canadian Cardiovascular Score angina score was 1.3 ( 0.05 ) ( P < 0.001 vs baseline ) .
CONCLUSIONS	Robotically assisted TMR can be performed using an endoscopic , optical-fiber-based LDS , with high procedural success , avoidance of early adverse clinical events , and potential for successful angina relief .

###24533608
OBJECTIVE	DBCare ( Ace Continental Exports Inc. , London , UK ) is a traditional Indian herbal food supplement marketed as an antidiabetes remedy .
OBJECTIVE	This study evaluated the efficacy and safety of DBCare in patients with inadequately controlled type 2 diabetes mellitus ( T2DM ) despite oral hypoglycemic treatment .
METHODS	A 12-week randomized double-blind placebo-controlled trial was conducted .
METHODS	Patients with T2DM on oral hypoglycemic agents with HbA1C > 7.0 % were randomized to receive DBCare or placebo tablets .
RESULTS	Thirty-five patients ( 20 male/15 female ; mean age 61.2 7.6 years ) , with a mean baseline HbA1C of 7.9 % 0.6 % , received DBCare ( N = 18 ) or placebo ( N = 17 ) .
RESULTS	During the study period , HbA1C declined 0.4 0.7 % in the DBCare group and 0.2 % 0.8 % in the placebo group ( p = 0.806 ) .
RESULTS	No significant changes occurred in fasting plasma glucose , lipid profile , or homeostasis model assessment throughout the study or in body mass index , waist circumference , or blood pressure values .
RESULTS	Hypoglycemic episodes ( glucose < 70 mg/dL ) were more frequent in the treatment group ( 7 vs 1 , p = 0.043 ) , necessitating a decrease in other hypoglycemic medications in 2 patients .
RESULTS	DBCare was generally well tolerated , with mild side effects that were not different from those of the placebo group .
CONCLUSIONS	This preliminary study did not demonstrate that DBCare was efficacious in improving glycemic control in inadequately controlled patients with T2DM on oral hypoglycemics .
CONCLUSIONS	A trend toward improved glycemic control was noted in the DBCare group , which correlates with more frequent hypoglycemic episodes .
CONCLUSIONS	Further studies are needed to elucidate DBCare 's hypoglycemic effect in patients with T2DM in general and in specific clinical settings , such as HbA1C 8 % , short ( 10-year ) duration of diabetes , or young age in particular .

###26037514
BACKGROUND	Postprandial hypoglycemia after gastric bypass surgery is a serious problem .
BACKGROUND	Available treatments are often ineffective .
OBJECTIVE	The objective was to test the hypotheses that injection of rapid-acting insulin before a high-carbohydrate meal or replacement of other carbohydrates with fructose in the meal would prevent hypoglycemia .
METHODS	This was a randomized , crossover trial comparing a high-carbohydrate meal with premeal saline injection ( control ) , a high-carbohydrate meal with premeal insulin injection , and a high-fructose meal with total carbohydrate content similar to the control meal .
METHODS	The setting was an academic medical center .
METHODS	Ten patients with post-gastric bypass hyperinsulinemic hypoglycemia participated .
METHODS	Interventions included lispro insulin injected before test meals and replacement of other carbohydrates with fructose in test meals .
METHODS	The main outcome measure was plasma glucose < 60 mg/dL after test meals .
RESULTS	After the control meal , mean peak glucose and insulin were 173 47 mg/dL and 134 55 mU/L , respectively ; mean glucose nadir was 44 15 mg/dL ; and eight of 10 subjects demonstrated glucose < 60 mg/dL .
RESULTS	Five subjects demonstrated a glucose nadir < 40 mg/dL .
RESULTS	There were no significant differences in the corresponding values after premeal insulin treatment , except that the mean glucose nadir of 34 10 mg/dL was lower ( P < .05 ) .
RESULTS	After the fructose meal , mean peak postprandial glucose and insulin were 117 20 mg/dL and 45 31 mU/L , respectively ( both P < .001 for comparison with control ) , mean glucose nadir was 67 10 mg/dL ( P < .001 ) , and two of 10 subjects demonstrated glucose < 60 mg/dL ( P < .05 ) .
CONCLUSIONS	People with post-gastric bypass hypoglycemia can consume a meal sweetened with fructose with little risk of hypoglycemia .
CONCLUSIONS	Treatment with rapid-acting insulin before a carbohydrate-containing meal did not prevent hypoglycemia .

###26369473
BACKGROUND	Randomised controlled trials have shown that bariatric surgery is more effective than conventional treatment for the short-term control of type-2 diabetes .
BACKGROUND	However , published studies are characterised by a relatively short follow-up .
BACKGROUND	We aimed to assess 5 year outcomes from our randomised trial designed to compare surgery with conventional medical treatment for the treatment of type 2 diabetes in obese patients .
METHODS	We did our open-label , randomised controlled trial at one diabetes centre in Italy .
METHODS	Patients aged 30-60 years with a body-mass index of 35 kg/m ( 2 ) or more and a history of type 2 diabetes lasting at least 5 years were randomly assigned ( 1:1:1 ) , via a computer-generated randomisation procedure , to receive either medical treatment or surgery by Roux-en-Y gastric bypass or biliopancreatic diversion .
METHODS	Participants were aware of treatment allocation before the operation and study investigators were aware from the point of randomisation .
METHODS	The primary endpoint was the rate of diabetes remission at 2 years , defined as a glycated haemaglobin A1c ( HbA1c ) concentration of 65 % or less ( 475 mmol/mol ) and a fasting glucose concentration of 56 mmol/L or less without active pharmacological treatment for 1 year .
METHODS	Here we analyse glycaemic and metabolic control , cardiovascular risk , medication use , quality of life , and long-term complications 5 years after randomisation .
METHODS	Analysis was by intention to treat for the primary endpoint and by per protocol for the 5 year follow-up .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00888836 .
RESULTS	Between April 27 , 2009 , and Oct 31 , 2009 , we randomly assigned 60 patients to receive either medical treatment ( n = 20 ) or surgery by gastric bypass ( n = 20 ) or biliopancreatic diversion ( n = 20 ) ; 53 ( 88 % ) patients completed 5 years ' follow-up .
RESULTS	Overall , 19 ( 50 % ) of the 38 surgical patients ( seven [ 37 % ] of 19 in the gastric bypass group and 12 [ 63 % ] of 19 in the bilipancreatic diversion group ) maintained diabetes remission at 5 years , compared with none of the 15 medically treated patients ( p = 00007 ) .
RESULTS	We recorded relapse of hyperglycaemia in eight ( 53 % ) of the 15 patients who achieved 2 year remission in the gastric bypass group and seven ( 37 % ) of the 19 patients who achieved 2 year remission in the biliopancreatic diversion group .
RESULTS	Eight ( 42 % ) patients who underwent gastric bypass and 13 ( 68 % ) patients who underwent biliopancreatic diversion had an HbA1c concentration of 65 % or less ( 475 mmol/mol ) with or without medication , compared with four ( 27 % ) medically treated patients ( p = 00457 ) .
RESULTS	Surgical patients lost more weight than medically treated patients , but weight changes did not predict diabetes remission or relapse after surgery .
RESULTS	Both surgical procedures were associated with significantly lower plasma lipids , cardiovascular risk , and medication use .
RESULTS	Five major complications of diabetes ( including one fatal myocardial infarction ) arose in four ( 27 % ) patients in the medical group compared with only one complication in the gastric bypass group and no complications in the biliopancreatic diversion group .
RESULTS	No late complications or deaths occurred in the surgery groups .
RESULTS	Nutritional side-effects were noted mainly after biliopancreatic diversion .
CONCLUSIONS	Surgery is more effective than medical treatment for the long-term control of obese patients with type 2 diabetes and should be considered in the treatment algorithm of this disease .
CONCLUSIONS	However , continued monitoring of glycaemic control is warranted because of potential relapse of hyperglycaemia .
BACKGROUND	Catholic University of Rome .

###24310580
BACKGROUND	Lipoabdominoplasty is nearly a daily aesthetic procedure .
BACKGROUND	Despite the emergence of laser-assisted liposuction , to date , it has not been clearly evaluated combined with abdominoplasty .
BACKGROUND	This prospective study aimed to evaluate the effectiveness and safety of laser-assisted liposuction relative to traditional liposuction combined with high-lateral-tension abdominoplasty .
METHODS	This study investigated 36 consecutive female patients who underwent high-lateral-tension abdominoplasty combined with liposuction of the upper central abdomen and both flanks .
METHODS	The patients were divided into three equal groups based on the technique used for liposuction .
METHODS	Group 1 underwent conventional liposuction with abdominoplasty .
METHODS	Group 2 underwent a mixture of conventional and laser-assisted liposuction with abdominoplasty .
METHODS	Group 3 underwent laser-assisted liposuction with abdominoplasty .
RESULTS	The patients in groups 2 and 3 had a better aesthetic outcome than those in group 1 with regard to abdominal contour and skin tightness .
RESULTS	No major complications were observed in groups 1 and 2 .
RESULTS	The patients in group 3 had a higher incidence of complications ( 3 seromas , 3 central necroses and dehiscence ) , and one patient underwent secondary sutures .
CONCLUSIONS	Laser-assisted liposuction combined with abdominoplasty in the lateral abdomen seems to be a safe technique with good aesthetic outcomes .
CONCLUSIONS	Although the combined use of laser-assisted liposuction in the lateral and central abdomen can achieve relatively better aesthetic results , it is associated with significant complications , and its use can not be supported .
CONCLUSIONS	Proper laser parameters in the central abdominal area still need further study .
METHODS	This journal requires that authors assign a level of evidence to each article .
METHODS	For a full description of these Evidence-Based Medicine ratings , please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

###24625833
OBJECTIVE	This study was performed to compare patient outcomes after Reamer-Irrigator-Aspirator ( RIA ) - harvested bone grafting with the current gold standard , either anterior or posterior iliac crest bone graft ( ICBG ) .
METHODS	Prospective randomized controlled trial .
METHODS	Multicenter study at 3 geographically separate Level 1 trauma centers .
METHODS	One hundred thirty-three patients with nonunion or posttraumatic segmental bone defect requiring operative intervention .
METHODS	Patients were prospectively randomized to receive ICBG or RIA autograft .
METHODS	Supplemental internal fixation was performed per surgeon preference .
METHODS	Operative data included amount of graft , time of harvest , and associated surgical costs .
METHODS	The Short Musculoskeletal Functional Assessment and the Visual Analog Scale were used to document baseline and postoperative function and pain .
METHODS	Clinical and radiographic union was the defined end point ; patients considered to have failed treatment if they either developed an infection requiring operative treatment or had a persistent nonunion of the grafted extremity .
RESULTS	One hundred thirteen of the 133 enrolled patients were followed until union and included in the final analysis .
RESULTS	Intraoperative data showed anterior ICBG to yield 20.7 12.8 ( 5-60 ) cm of autograft with an average harvest time of 33.2 16.2 minutes , posterior ICBG yielded 36.1 21.3 ( 20-100 ) cm of autograft in 40.6 11.2 minutes , and RIA yielded 37.7 12.9 ( 5-90 ) cm in 29.4 15.1 minutes .
RESULTS	Anterior ICBG produced significantly less bone graft than either RIA or posterior ICBG ( P < 0.001 ) .
RESULTS	The RIA harvest was completed in significantly less operative time compared with posterior ICBG ( P = 0.005 ) .
RESULTS	At $ 738 , the RIA setup was considerably more expensive than the $ 100 cost of a bone graft tray ; however , when compared with posterior ICBG , the longer operative time required for a posterior harvest came at an additional incremental cost of $ 990-1880 , making RIA the less expensive option .
RESULTS	Patients were followed for an average of 56.9 42.1 ( 11-250 ) weeks .
RESULTS	Forty-nine of 57 patients ( 86.0 % ) who received ICBG united in an average of 22.5 13.2 weeks ; 46 of 56 patients ( 82.1 % ) who received RIA healed in an average of 25.8 17.0 weeks .
RESULTS	Union rates and time to union were comparable between the 2 procedures .
RESULTS	There was no difference in complications requiring reoperation for persistent nonunion or infection at the grafted site , nor there was any difference in donor-site complications .
RESULTS	Postoperative follow-up showed that RIA patients had significantly lower donor-site pain scores throughout follow-up .
CONCLUSIONS	When compared with autograft obtained from the iliac crest , autograft harvested using the RIA technique achieves similar union rates with significantly less donor-site pain .
CONCLUSIONS	RIA also yields a greater volume of graft compared with anterior ICBG and has a shorter harvest time compared with posterior ICBG .
CONCLUSIONS	For larger volume harvests , cost analysis favors using RIA .
METHODS	Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence .

###24809976
BACKGROUND	The early biological impact of short-term mechanical ventilation on healthy lungs is unknown .
BACKGROUND	The authors aimed to characterize the immediate tidal volume ( VT ) - related changes on lung injury biomarkers in patients with healthy lungs and low risk of pulmonary complications .
METHODS	Twenty-eight healthy patients for knee replacement surgery were prospectively randomized to volume-controlled ventilation with VT 6 ( VT6 ) or 10 ( VT10 ) ml/kg predicted body weight .
METHODS	General anesthesia and other ventilatory parameters ( positive end-expiratory pressure , 5 cm H2O , FIO2 , 0.5 , respiratory rate titrated for normocapnia ) were managed similarly in the two groups .
METHODS	Exhaled breath condensate and blood samples were collected for nitrite , nitrate , tumor necrosis factor - , interleukins-1 , -6 , -8 , -10 , -11 , neutrophil elastase , and Clara Cell protein 16 measurements , at the onset of ventilation and 60 min later .
RESULTS	No significant differences in biomarkers were detected between the VT groups at any time .
RESULTS	The coefficient of variation of exhaled breath condensate nitrite and nitrate decreased in the VT6 but increased in the VT10 group after 60-min ventilation .
RESULTS	Sixty-minute ventilation significantly increased plasma neutrophil elastase levels in the VT6 ( 35.2 30.4 vs. 56.4 51.7 ng/ml , P = 0.008 ) and Clara Cell protein 16 levels in the VT10 group ( 16.4 8.8 vs. 18.7 9.5 ng/ml , P = 0.015 ) .
RESULTS	Exhaled breath condensate nitrite correlated with plateau pressure ( r = 0.27 , P = 0.042 ) and plasma neutrophil elastase ( r = 0.44 , P = 0.001 ) .
RESULTS	Plasma Clara Cell protein 16 correlated with compliance ( r = 0.34 , P = 0.014 ) .
CONCLUSIONS	No tidal volume-related changes were observed in the selected lung injury biomarkers of patients with healthy lungs after 60-min ventilation .
CONCLUSIONS	Plasma neutrophil elastase and plasma Clara Cell protein 16 might indicate atelectrauma and lung distention , respectively .

###25192851
BACKGROUND	Teriflunomide is a once-daily oral immunomodulator approved for the treatment of relapsing-remitting multiple sclerosis .
BACKGROUND	We aimed to assess the efficacy and safety of teriflunomide in patients with a first clinical episode suggestive of multiple sclerosis .
METHODS	In this randomised , double-blind , placebo-controlled , parallel-group study , we enrolled patients aged 18-55 years with clinically isolated syndrome ( defined as a neurological event consistent with demyelination , starting within 90 days of randomisation , and two or more T2-weighted MRI lesions 3 mm in diameter ) from 112 centres ( mostly hospitals ) in 20 countries .
METHODS	Participants were randomly assigned ( 1:1:1 ) in a double-blind manner ( by an interactive voice response system ) to once-daily oral teriflunomide 14 mg , teriflunomide 7 mg , or placebo , for up to 108 weeks .
METHODS	Patients , staff administering the interventions , and outcome assessors were masked to treatment assignment .
METHODS	The primary endpoint was time to relapse ( a new neurological abnormality separated by 30 days from a preceding clinical event , present for 24 h in the absence of fever or known infection ) , which defined conversion to clinically definite multiple sclerosis .
METHODS	The key secondary endpoint was time to relapse or new gadolinium-enhancing or T2 lesions on MRI , whichever occurred first .
METHODS	The primary outcome was analysed for the modified intention-to-treat population ; safety analyses included all randomised patients who were exposed to the study drug , as treated .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00622700 .
RESULTS	Between Feb 13 , 2008 , and Aug 22 , 2012 , 618 patients were enrolled and randomly assigned to teriflunomide 14 mg ( n = 216 ) , teriflunomide 7 mg ( n = 205 ) , or placebo ( n = 197 ) .
RESULTS	Two patients in each of the teriflunomide groups did not receive the study drug , so the modified intention-to-treat population comprised 214 patients in the teriflunomide 14 mg group , 203 in the teriflunomide 7 mg group , and 197 in the placebo group .
RESULTS	Compared with placebo , teriflunomide significantly reduced the risk of relapse defining clinically definite multiple sclerosis at the 14 mg dose ( hazard ratio [ HR ] 0574 [ 95 % CI 0379-0869 ] ; p = 00087 ) and at the 7 mg dose ( 0628 [ 0416-0949 ] ; p = 00271 ) .
RESULTS	Teriflunomide reduced the risk of relapse or a new MRI lesion compared with placebo at the 14 mg dose ( HR 0651 [ 95 % CI 0515-0822 ] ; p = 00003 ) and at the 7 mg dose ( 0686 [ 0540-0871 ] ; p = 00020 ) .
RESULTS	During the study , six patients who were randomly assigned to placebo accidently also received teriflunomide at some point : four received 7 mg and two received 14 mg .
RESULTS	Therefore , the safety population comprised 216 patients on teriflunomide 14 mg , 207 on teriflunomide 7 mg , and 191 on placebo .
RESULTS	Adverse events that occurred in at least 10 % of patients in either teriflunomide group and with an incidence that was at least 2 % higher than that with placebo were increased alanine aminotransferase ( 40 [ 19 % ] of 216 patients in the 14 mg group , 36 [ 17 % ] of 207 in the 7 mg group vs 27 [ 14 % ] of 191 in the placebo group ) , hair thinning ( 25 [ 12 % ] and 12 [ 6 % ] vs 15 [ 8 % ] ) , diarrhoea ( 23 [ 11 % ] and 28 [ 14 % ] vs 12 [ 6 % ] ) , paraesthesia ( 22 [ 10 % ] and 11 [ 5 % ] vs 10 [ 5 % ] ) , and upper respiratory tract infection ( 20 [ 9 % ] and 23 [ 11 % ] vs 14 [ 7 % ] ) .
RESULTS	The most common serious adverse event was an increase in alanine aminotransferase ( four [ 2 % ] and five [ 2 % ] vs three [ 2 % ] ) .
CONCLUSIONS	TOPIC is to our knowledge the first study to report benefits of an available oral disease-modifying therapy in patients with early multiple sclerosis .
CONCLUSIONS	These results extend the stages of multiple sclerosis in which teriflunomide shows a beneficial effect .
BACKGROUND	Genzyme , a Sanofi company .

###25024314
BACKGROUND	ABT-288 , a highly selective histamine-3 receptor antagonist , demonstrated efficacy across several preclinical cognitive domains , and safety in healthy subjects and elderly volunteers .
OBJECTIVE	Evaluate the efficacy and safety of ABT-288 in subjects with mild-to-moderate Alzheimer 's dementia .
METHODS	The study used a randomized , double-blind , placebo - and active-controlled , parallel group design with pre-defined futility criteria to permit early study termination .
METHODS	A total of 242 subjects were randomized in an equal ratio to ABT-288 1 mg or 3 mg , donepezil 10 mg , or placebo once daily for 12 weeks .
METHODS	The primary efficacy endpoint was the change from baseline to final evaluation on the 13-item Alzheimer 's Disease Assessment Scale-cognitive subscale ( ADAS-Cog ) total score .
RESULTS	The study was prematurely terminated because futility criteria were met .
RESULTS	Point estimates on the ADAS-Cog scores for both ABT-288 dose groups were numerically inferior to placebo but no statistical differences were detected .
RESULTS	Donepezil demonstrated statistically significant improvement .
RESULTS	Adverse events were generally mild and self-limiting .
CONCLUSIONS	ABT-288 did not demonstrate efficacy in the symptomatic treatment of Alzheimer 's dementia .

###25560349
BACKGROUND	Failure in complete healing of the wound is one of the probable complications of cesarean .
BACKGROUND	The present study aimed to determine the effectiveness of dressing with aloe vera gel in healing of cesarean wound .
METHODS	This prospective randomized double-blind clinical trial was conducted on 90 women who had undergone cesarean operation in Amir-al-Momenin hospital ( Gerash , Iran ) .
METHODS	The participants were randomly divided into two groups each containing 45 patients .
METHODS	In one group , the wound was dressed with aloe vera gel , while simple dressing was used in the control group .
METHODS	Wound healing was assessed 24 hours and 8 days after the cesarean operation using REEDA scale .
METHODS	The data were analyzed through Chi-square and t-test .
RESULTS	The participants ' mean age was 27.564.20 in the aloe vera group and 26.624.88 in the control group , but the difference was not statistically significant .
RESULTS	However , a significant difference was found between the two groups concerning body mass index , heart rate , and systolic blood pressure ( P < 0.05 ) .
RESULTS	Also , a significant difference was observed between the two groups with respect to the wound healing score 24 hours after the operation ( P = 0.003 ) .
RESULTS	After 8 days , however , the difference in the wound healing score was not significant ( P = 0.283 ) .
RESULTS	Overall , 45 participants in the aloe vera group and 35 ones in the control group had obtained a zero score 24 hours after the operation .
RESULTS	These measures were respectively obtained as 42 and 41eight days after the operation .
CONCLUSIONS	According to the findings of this study , the women are recommended to be informed regarding the positive effects of dressing with aloe vera gel .

###25080906
OBJECTIVE	To determine the protective effect of zero-balanced ultrafiltration and modified ultrafiltration on infants ' pulmonary function after cardiac surgery .
METHODS	Sixty infants with congenital heart diseases were randomly divided into 3 groups : a zero-balanced ultrafiltration group ( Z group ) , a modified ultrafiltration group ( M group ) and a zero-balanced ultrafiltration with modified ultrafiltration group ( Z+M group ) .
METHODS	Oxygenation index ( OI ) , difference of alveoli-arterial oxygen pressure ( P ( A - ) O2 ) , static lung compliance ( Cstat ) , and airway resistance ( Raw ) were measured before caridopulmonary bypass ( CPB , T1 ) , 20 minutes after the CPB ( T2 ) , 2 h after the operation ( T3 ) , 6 h after the operation ( T4 ) and 12 h after the operation ( T5 ) .
METHODS	The time of mechanical ventilation was also monitored .
RESULTS	After the CPB , OI and Cstat in all groups decreased significantly , while Raw and P ( A - ) O2 increased significantly .
RESULTS	At T3 , T4 and T5 , OI and Cstat in the Z+M group were significantly higher than those in the Z group and the M group ( P < 0.05 ) , Raw and P ( A - ) O2 in the Z+M group were significantly lower than those in the Z group and the M group ( P < 0.05 ) .
RESULTS	The ventilation time in the Z+M group was significantly shorter than that in the Z group and the M group ( P < 0.05 ) .
CONCLUSIONS	Zero-balanced ultrafiltration and modified ultrafiltration can effectively promote the pulmonary function after cardiac surgery in infants .

###25600221
BACKGROUND	Exposure to ozone has acute respiratory effects , but few human clinical studies have evaluated cardiovascular effects .
OBJECTIVE	We hypothesized that ozone exposure alters pulmonary and systemic vascular function , and cardiac function , with more pronounced effects in subjects with impaired antioxidant defense from deletion of the glutathione-S-transferase M1 gene ( GSTM1 null ) .
METHODS	Twenty-four young , healthy never-smoker subjects ( 12 GSTM1 null ) inhaled filtered air , 100ppb ozone and 200ppb ozone for 3h , with intermittent exercise , in a double-blind , randomized , crossover fashion .
METHODS	Exposures were separated by at least 2 weeks .
METHODS	Vital signs , spirometry , arterial and venous blood nitrite levels , impedance cardiography , peripheral arterial tonometry , estimation of pulmonary capillary blood volume ( Vc ) , and blood microparticles and platelet activation were measured at baseline and during 4h after each exposure .
RESULTS	Ozone inhalation decreased lung function immediately after exposure ( meanstandard error change in FEV1 , air : -0.030.04 L ; 200ppb ozone : -0.300.07 L ; p < 0.001 ) .
RESULTS	The immediate post-exposure increase in blood pressure , caused by the final 15-min exercise period , was blunted by 200ppb ozone exposure ( meanstandard error change for air : 16.72.6 mmHg ; 100ppb ozone : 14.52.4 mmHg ; 200ppb ozone : 8.52.5 mmHg ; p = 0.02 ) .
RESULTS	We found no consistent effects of ozone on any other measure of cardiac or vascular function .
RESULTS	All results were independent of the GSTM1 genotype .
CONCLUSIONS	We did not find convincing evidence for early acute adverse cardiovascular consequences of ozone exposure in young healthy adults .
CONCLUSIONS	The ozone-associated blunting of the blood pressure response to exercise is of unclear clinical significance .

###25212474
OBJECTIVE	To report a study protocol that tests the effectiveness of an educational intervention on outcomes of parents and their children who undergo inpatient elective surgery .
BACKGROUND	Inadequate children 's postoperative pain management remains a global problem .
BACKGROUND	Parents are required to be involved in their child 's pain assessment and management , yet they often lack relevant knowledge and skills .
BACKGROUND	Education is an effective strategy for enhancing a person 's knowledge , attitudes and behaviour .
BACKGROUND	However , few studies have examined its effectiveness in parents and their children undergoing inpatient elective surgery .
METHODS	Randomized controlled trial and embedded qualitative process evaluation .
METHODS	One hundred and sixty-two pairs of participants ( each comprised of one parent and his/her child undergoing inpatient elective surgery ) will be recruited ( protocol approved in January 2013 ) .
METHODS	Participants will be randomized to either a Control group ( routine care ) , an Intervention group 1 ( routine care and an educational intervention with face-to-face teaching ) , or an Intervention group 2 ( routine care and an educational intervention without face-to-face teaching ) .
METHODS	Outcome measures will include parents ' knowledge , attitude and behaviour related to postoperative pain management ; their child 's postoperative pain ; and parents ' satisfaction with their child 's pain management at baseline and around 6 , 12 and 24 hours after the operation .
CONCLUSIONS	A standardized educational intervention protocol and detailed study procedure have been developed in this study to improve parents ' knowledge , attitude and behaviour related to postoperative pain management and reduce their child 's postoperative pain .

###24721483
BACKGROUND	Urolithiasis ( kidney stones ) is a common reason for Emergency Department ( ED ) visits , accounting for nearly 1 % of all visits in the United States .
BACKGROUND	Computed tomography ( CT ) has become the most common imaging test for these patients but there are few comparative effectiveness data to support its use in comparison to ultrasound .
BACKGROUND	This paper describes the rationale and methods of STONE ( Study of Tomography Of Nephrolithiasis Evaluation ) , a pragmatic randomized comparative effectiveness trial comparing different imaging strategies for patients with suspected urolithiasis .
METHODS	STONE is a multi-center , non-blinded pragmatic randomized comparative effectiveness trial of patients between ages 18 and 75 with suspected nephrolithiasis seen in an ED setting .
METHODS	Patients were randomized to one of three initial imaging examinations : point-of-care ultrasound , ultrasound performed by a radiologist or CT. .
METHODS	Participants then received diagnosis and treatment per usual care .
METHODS	The primary aim is to compare the rate of severe SAEs ( Serious Adverse Events ) between the three arms .
METHODS	In addition , a broad range of secondary outcomes was assessed at baseline and regularly for six months post-baseline using phone , email and mail questionnaires .
RESULTS	Excluding 17 patients who withdrew after randomization , a total of 2759 patients were randomized and completed a baseline questionnaire ( n = 908 , 893 and 958 in the point-of-care ultrasound , radiology ultrasound and radiology CT arms , respectively ) .
RESULTS	Follow-up is complete , and full or partial outcomes were assessed on over 90 % of participants .
CONCLUSIONS	The detailed methodology of STONE will provide a roadmap for comparative effectiveness studies of diagnostic imaging conducted in an ED setting .

###24698298
OBJECTIVE	To assess pain intensity with and without subcutaneous local anesthesia prior to intraarticular administration of contrast medium for magnetic resonance arthrography ( MRa ) of the shoulder .
METHODS	This single-center study was conducted after an IRB waiver of authorization , between January 2010 and December 2012 .
METHODS	All patients provided written , informed consent for the procedure .
METHODS	Our prospectively populated institutional database was searched , based on our inclusion criteria .
METHODS	There were 249 outpatients ( 178 men and 71 women ; mean age , 44.4 years 14.6 ; range , 15-79 ) who underwent MRa and were enrolled in this study .
METHODS	Patients were excluded if they had received surgery of the shoulder before MRa , had undergone repeated MRa of the same shoulder , and/or had undergone MRa of both shoulders on the same day .
METHODS	Patients were randomly assigned into one of three groups .
METHODS	Patients in group A ( n = 61 ) received skin infiltration with local anesthesia .
METHODS	Patients in control group B ( n = 92 ) and group C ( n = 96 ) did not receive local anesthesia .
METHODS	Pain levels were immediately assessed after the injection for MRa using a horizontal visual analog scale ( VAS ) that ranged from 0 to 10 .
METHODS	To compare the pain scores of the three groups for male and female patients , a two-way analysis of variance was used .
METHODS	A p-value equal to or less than 0.05 was considered to indicate a significant result .
RESULTS	Patients who received local anesthesia ( group A ) showed a mean pain level on the VAS of 2.6 2.3 .
RESULTS	In patients who did not receive local anesthetics ( groups B and C ) , a mean pain level on the VAS of 2.6 2.2 and 2.7 2.4 were detected , respectively .
RESULTS	Between the three groups , no statistically significant difference in pain intensity was detected ( p = .960 ) .
RESULTS	There were significant differences in subjective pain perception between men and women ( p = .009 ) .
RESULTS	Moreover , the sex difference in all three groups was equal ( p = .934 ) .
CONCLUSIONS	Local anesthesia is not required to lower a patient 's pain intensity when applying intra-articular contrast media for MR arthrography of the shoulder .
CONCLUSIONS	This could result in reduced costs and a reduced risk of adverse reactions , without an impact on patient comfort .

###24494286
OBJECTIVE	To observe the difference in the efficacy on traumatic nerve injury among electroacupuncture , warm needling therapy and electroacupuncture plus warm needling therapy and explore the better therapeutic method .
METHODS	The electromyography ( EMG ) and electroneurography ( ENG ) of 93 cases showed traumatic nerve injury of moderate damage .
METHODS	According to the single blind randomization principle , they were divided into an electroacupuncture ( EA ) group , a warm needling therapy ( WN ) group and an EA plus WN group , 31 cases in each one .
METHODS	The main acupoints were selected from Yangming Meridian and Shaoyang Meridian corresponding to the distribution of damaged nerves .
METHODS	EA , WN and EA plus WN were applied separately .
METHODS	The treatment was given once every day , 15 treatments made one session .
METHODS	After 3 sessions of treatment ( 45 treatments in total ) , EMG and ENG were re-checked and the results were analyzed statistically .
RESULTS	Regarding the total effective rate and effective rate , it was 96.8 % ( 30/31 ) in the EA plus WN group , which was better than 74.2 % ( 23/31 ) in the EA group and 77.4 % ( 24/31 ) in the WN group ( P < 0.05 ) .
RESULTS	Concerning to the improvements of EMG , the result in the EA plus WN group was 96.8 % ( 30/31 ) , which was better than the other two groups [ 74.2 % ( 23/31 ) ,74.2 % ( 23/31 ) ] ( P < 0.05 ) .
RESULTS	In terms of the recovery of nerve conduction and amplitude , the results in EA plus WN group [ ( 50.9 + / -4.6 ) m/s , ( 8.8 + / -2.9 ) , microVx1 000 ] were better than the other two groups [ ( 43.7 + / -3.1 ) m/s , ( 4.2 + / -1.9 ) microV X 1 000 , ( 43.8 + / -3.3 ) m/s , ( 4.5 + / -2.2 ) microV X 1 000 ] ( P < 0.05 ) .
CONCLUSIONS	EA combined with WN is a better therapy of acupuncture and moxibustion in the treatment of traumatic nerve injury .

###24996856
OBJECTIVE	The aim of this study was to compare the skeletal and dental effects of the EVAA appliance with those of an activator appliance in growing children with skeletal Class II anomalies .
METHODS	A total of 34 subjects with Class II anomalies were recruited for this study .
METHODS	They were divided into three groups : the EVAA group ( n = 13 ; mean chronological age : 11 years 9 months ) , activator group ( n = 13 ; mean chronological age : 11 years 8 months ) and control group ( n = 8 ; mean chronological age : 10 years 8 months ) .
METHODS	Lateral cephalometric radiographs were taken at the beginning and end of functional therapy .
METHODS	Fixed orthodontic treatment was completed in the EVAA group .
METHODS	A statistical software program ( SPSS 18 ) was used for one-way analysis of variance and multiple comparisons with the Duncan test .
RESULTS	We observed a significant decrease in the ANB , convexity , and 1NA ( ) , while a significant increase appeared in upper anterior facial height , posterior facial height , 1NB ( mm ) , SN-lower occlusal plane values in the EVAA and activator groups after treatment ( p < 0.05 ) .
RESULTS	No significant difference in study parameters in the control group during the treatment period except for the increase in SNA and 1NA ( mm ) values ( p < 0.05 ) were observed .
RESULTS	There were no significant differences between EVAA and activator treatment groups in terms of study parameters except for the articular angle , which was significantly higher in the EVAA group after therapy ( p < 0.05 ) .
CONCLUSIONS	The effects of EVAA appliances were similar to those of activator treatment .

###24739993
BACKGROUND	The objectives of this study were to present the rationale for the main aspects of the study design and describe the trial methodology for the Idiopathic Intracranial Hypertension Treatment Trial ( IIHTT ) .
METHODS	Eligible candidates with mild visual field loss ( automated perimetric mean deviation [ PMD ] -2 to -7 dB ) were randomized to receive either acetazolamide or matching placebo tablets .
METHODS	Randomized participants were offered participation in a supervised dietary program .
METHODS	The primary outcome variable , PMD , was measured at 6 months .
METHODS	Additionally , cerebrospinal fluid from subjects and serum from study participants and matched controls were collected for genetic analysis and vitamin A studies .
METHODS	An ancillary optical coherence substudy was added to investigate the changes of papilledema in the optic nerve head and retina that correlate with Frisn grading , visual field deficits , and low-contrast visual acuity .
RESULTS	The randomized trial entered 165 participants from March 17 , 2010 , through November 27 , 2012 , from the United States and Canada .
RESULTS	The primary outcome ( month 6 ) visits were successfully completed by June 15 , 2013 .
RESULTS	Blood specimens were obtained from 165 controls without IIH to investigate vitamin A metabolism and genetic markers of potential risk factors for IIH .
CONCLUSIONS	The IIHTT is the first randomized , double-masked placebo-controlled trial to study the effectiveness of medical treatment for patients with IIH .

###25784662
OBJECTIVE	The aim of this study was to assess the efficacy of a 12-month prevention program conducted in 42 community pharmacies in reducing the risk for diabetes .
METHODS	In a cluster-randomized controlled trial in 1,092 participants , mean change in the risk for diabetes ( indicated by the Finnish Diabetes Risk Score [ FINDRISC ] ) between intervention and control groups was calculated .
METHODS	In the intervention program GLICEMIA , three appointments with individual counseling and five educational group sessions were combined , whereas in the control group , only information about the participants ' health was obtained in three assessments .
RESULTS	After adjusting for cluster structure and differences in baseline characteristics , improvement in FINDRISC in the intervention group was 0.74 points ( 95 % CI 0.42-1 .04 ) above the control group .
CONCLUSIONS	The GLICEMIA program shows the feasibility of a pharmacy-based intervention and leads to a significant modest reduction in diabetes risk score but does not reduce the rate of diabetes progression over 1 year .

###24398339
OBJECTIVE	Telavancin is approved in Europe for the treatment of nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus when other alternatives are not suitable .
OBJECTIVE	The approved European prescribing information contraindicates the use of telavancin in patients with severe renal impairment ( creatinine clearance < 30 mL/min , including patients on haemodialysis ) and pre-existing acute renal failure owing to the higher observed mortality in these patients .
OBJECTIVE	Data from the ATTAIN studies were reanalysed , excluding patients with these contraindicating conditions at baseline .
OBJECTIVE	( At the time of submission of this article , the European marketing authorization of telavancin for the treatment of nosocomial pneumonia was suspended pending evidence of a new European Medicines Agency-approved supplier .
OBJECTIVE	Clinigen Healthcare Ltd , Theravance 's commercialization partner for telavancin in Europe , is in the process of seeking approval of a new manufacturing source . )
METHODS	A post hoc analysis of data from two Phase 3 ATTAIN trials of telavancin for the treatment of Gram-positive nosocomial pneumonia assessing clinical outcomes and safety .
RESULTS	The all-treated population for this analysis represented 84.2 % ( 1266/1503 ) of the ATTAIN all-treated population .
RESULTS	The cure rates in the clinically evaluable population were similar in the telavancin ( 82.5 % , 231/280 ) and vancomycin ( 81.3 % , 243/299 ) groups [ treatment difference ( 95 % CI ) : 1.3 % ( -5.0 % to 7.6 % ) ] , and were consistent with the overall ATTAIN study results .
RESULTS	The cure rate was higher in the telavancin than the vancomycin treatment group in microbiologically evaluable patients with only Gram-positive pathogens isolated at baseline [ 85.0 % ( 130/153 ) versus 75.2 % ( 109/145 ) , respectively ; treatment difference ( 95 % CI ) : 9.7 % ( 0.6 % -18.8 % ) ] .
RESULTS	The incidences of adverse events were similar between treatment groups and consistent with the overall findings of the ATTAIN study .
CONCLUSIONS	This analysis demonstrated that in the subset of patients without severe renal impairment or pre-existing acute renal failure , clinical and safety outcomes were similar in the telavancin and vancomycin treatment groups .

###26033265
OBJECTIVE	To evaluate the safety and efficacy of adjuvant intensity-modulated radiotherapy ( IMRT ) with concurrent paclitaxel and cisplatin ( TP ) in early stage cervical cancer patients with high risk factors after radical hysterectomy .
METHODS	Patients who underwent radical hysterectomy for FIGO stage IB-IIA cervical cancer and had high risk factors for recurrence were recruited .
METHODS	One cycle of TP was delivered before and after concurrent chemoradiotherapy , respectively .
METHODS	Concurrent chemoradiotherapy began 21 days after the start of the initial cycle of the chemotherapy with two cycles of TP delivered on day 1 and day 29 of radiotherapy .
METHODS	Primary endpoints were overall survival ( OS ) and relapse-free survival ( RFS ) , with toxicities , local-regional control ( LC ) and distant failure ( DF ) rate as secondary endpoints .
RESULTS	Between 2008 and 2012 , 67 patients were evaluable .
RESULTS	The 2 and 4-year RFS rates were 98.2 % and 92.9 % .
RESULTS	Corresponding OS rates were 100 % , and 98.0 % , respectively .
RESULTS	The 4-year LC and DF rates were 98.0 % and 5.2 % , respectively .
RESULTS	Grade 3-4 acute leucopenia , neutropenia and thrombocytopenia occurred in 25.4 % , 11.9 % and 1.5 % of patients , respectively .
RESULTS	There were 89.6 % and 59.7 % patients experienced acute vomiting and diarrhea , but only 6.0 % and 6.0 % patients were grade 3 , respectively .
RESULTS	No case of chronic toxicity exceeded grade 2 .
CONCLUSIONS	Adjuvant concurrent IMRT with paclitaxel plus cisplatin are safe and effective in early stage cervical cancer patients with high risk factors for recurrence following radical hysterectomy .

###24228535
OBJECTIVE	To observe the effection of immune reconstitution efficiency and the immune function on Immune 2 with HAART to HIV/AIDS patients which poor immune reconstitution after HAART .
METHODS	Two hundred and sixty four patients failure to immune reconstitution after HAART were randomly divided into treatment group ( 131 cases ) and control group ( 133 cases ) , respectively , using Immune 2 plus HAART and placebo combined with HAART for 6 months .
METHODS	the CD4 , CD8 , CD45RA , CD45RO , CD4CD28 , CD8CD28 , CD8CD38 , HLA-DR and CD4CD25 were observed in order to evaluate the immune reconstitution efficiency .
RESULTS	After the intervention for 6 months , the effective rate of treatment group ( 34.48 % ) was significantly superior to the control group ( 21.37 % ) ( P = 0.0217 ) .
RESULTS	Treated group could significantly increased the CD4 , CD45RA , CD45RO cell counts compared with control group ( P < 0.05 ) ; CD8 , CD3 , CD4CD28 absolute count comparison between the two groups had no significant difference ; CD8CD28 relative counting the treatment group group significantly increased ( P < 0.05 ) compared to the control ; CD4CD28 , CD8CD38 , CD8DR , CD4CD25 relative counting groups showed no significant difference .
CONCLUSIONS	Immune 2 can effectively improve the immune reconstitution efficiency , CD4 counts , CD45RA counts and CD45RO counts of patients after HAART , therefore promoting immune reconstitution .

###24982917
OBJECTIVE	The purpose of this study was to compare the analgesic properties of levobupivacaine with or without fentanyl for patient-controlled epidural analgesia after Cesarean section in a randomized , double-blinded study .
METHODS	We enrolled American Society of Anesthesiologists class I/II , full-term pregnant women at National Taiwan University Hospital who received patient-controlled epidural analgesia after Cesarean section between 2009 and 2010 .
METHODS	Eighty women were randomly assigned into two groups .
METHODS	In group A , the 40 subjects received drug solutions made of 0.6 mg/ml levobupivacaine plus 2mcg/ml fentanyl , and in group B the 40 subjects received 1mg/ml levobupivacaine .
METHODS	Maintenance was self-administered boluses and a continuous background infusion .
RESULTS	There were no significant differences in the resting and dynamic pain scales and total volume of drug used between the two groups .
RESULTS	Patient satisfaction was good in both groups .
CONCLUSIONS	Our study showed that pure epidural levobupivacaine can provide comparative analgesic properties to the levobupivacaine-fentanyl combination after Cesarean section .
CONCLUSIONS	Pure levobupivacaine may serve as an alternative pain control regimen to avoid opioid-related adverse events in parturients .

###24866273
OBJECTIVE	To determine whether physiotherapy is more effective when applied in blocks or continuously in children with cerebral palsy ( CP ) .
METHODS	A prospective randomized cross-over design study compared the effect of regular physiotherapy ( baseline ) with blocks of physiotherapy alternating with no physiotherapy over one year .
METHODS	Thirty-nine institutionalized children with CP and clinically similar syndromes ( 6-16 years old , Gross Motor Function Classification Scale II-IV ) were included .
METHODS	During the first scholastic year , group A received regular physiotherapy , group B blocks of physiotherapy and vice versa in the second year .
METHODS	The Gross Motor Function Measure 66 ( GMFM-66 ) was the outcome measure .
RESULTS	Thirteen children in each group completed the study .
RESULTS	GMFM-66 improved ( p < 0.05 ) over the study period in both groups in total ; changes ( p < 0.05 ) were seen only in dimension D ( group B ) and E ( both groups ) during regular therapy .
CONCLUSIONS	Physiotherapy may be more effective when provided regularly rather than in blocks .

###24603201
OBJECTIVE	To investigate the effectiveness of a combined social and physical environmental intervention as well as the effectiveness of both separate interventions .
METHODS	In a 2 2 factorial design , 412 office employees were allocated to the combined social and physical environmental intervention , to the social environmental intervention only , to the physical environmental intervention only , or were part of the control group .
METHODS	Data on presenteeism , absenteeism , work performance , and work engagement were obtained with questionnaires at baseline , 6 , and 12 months .
METHODS	Multilevel analyses were performed .
RESULTS	The combined intervention showed a decrease in contextual performance and dedication .
RESULTS	The social environmental intervention showed an improvement in task performance .
RESULTS	The physical environmental intervention revealed an improvement in absorption .
CONCLUSIONS	Although the study showed some promising results , it is not recommended to implement the current interventions .

###25150638
OBJECTIVE	We examine the cross-sectional associations between baseline characteristics and sexual function and the longitudinal associations between change in lower urinary tract symptoms and change in sexual function among men with benign prostatic hyperplasia .
METHODS	We studied lower urinary tract symptoms assessed by the AUA-SI and sexual function determined by the BMSFI in men enrolled in the MTOPS study .
METHODS	The cross-sectional cohort included 2,916 men who completed the BMSFI at baseline .
METHODS	The longitudinal cohort included 672 men who were randomized to placebo and had completed the BMSFI at baseline and at least once during a 4-year followup .
METHODS	Multiple adjusted linear modeling for each domain of the BMSFI was performed to assess associations of sexual function with lower urinary tract symptoms .
RESULTS	After adjustment for baseline demographic and clinical characteristics , increased age , less education , obesity and severe lower urinary tract symptoms were each significantly associated with poorer sexual drive , erectile function , ejaculatory function , sexual problem assessment and overall satisfaction in the cross-sectional cohort .
RESULTS	However , none of these baseline characteristics predicted change in sexual function in the longitudinal cohort .
RESULTS	Decline in sexual function in all sexual function domains associated with worsening of lower urinary tract symptoms in this group was small .
CONCLUSIONS	Increased age , less education , obesity and more severe lower urinary tract symptoms were individually associated cross-sectionally , but not longitudinally , with poorer sexual function in men with lower urinary tract symptoms/benign prostatic hyperplasia .
CONCLUSIONS	The decline in sexual function associated with worsening of lower urinary tract symptoms in men assigned to placebo was small .

###24734241
BACKGROUND	This study was conducted to compare and evaluate the effect of adding lornoxicam or nitroglycerine as adjuncts to lidocaine in intravenous regional anesthesia ( IVRA ) .
METHODS	60 patients were randomly separated into three groups , lidocaine group ( group L ) , lidocaine + lornoxicam group ( group LL ) , and lidocaine + lornoxicam + transdermal nitroglycerine group ( group LL-N ) .
METHODS	Hemodynamic parameters , sensory and motor blocks onset , and recovery times were recorded .
METHODS	Analgesic consumption for tourniquet pain and postoperative period were recorded .
RESULTS	Sensory block onset times and motor block onset times were shorter in the LL-N and LL groups compared with L group .
RESULTS	Sensory block recovery time and motor block recovery time were prolonged in the LL and LL-N groups compared with group L.
RESULTS	The amount of fentanyl required for tourniquet pain was less in group LL and group LL-N when compared with group L. VAS scores of tourniquet pain were higher in group L compared with the other study groups .
RESULTS	Postoperative VAS scores were higher for the first 4 hours in group L compared with the other study groups .
CONCLUSIONS	The adjuvant drugs ( lornoxicam or TNG ) when added to lidocaine in IVRA were effective in improving the overall quality of anesthesia , reducing tourniquet pain , increasing tourniquet tolerance , and improving the postoperative analgesia .

###24469862
BACKGROUND	To reduce the risk of adjustment problems associated with hematopoietic stem cell transplant ( HSCT ) for adolescents/young adults ( AYAs ) , we examined efficacy of a therapeutic music video ( TMV ) intervention delivered during the acute phase of HSCT to : 1 ) increase protective factors of spiritual perspective , social integration , family environment , courageous coping , and hope-derived meaning ; 2 ) decrease risk factors of illness-related distress and defensive coping ; and 3 ) increase outcomes of self-transcendence and resilience .
METHODS	This was a multisite randomized , controlled trial ( COG-ANUR0631 ) conducted at 8 Children 's Oncology Group sites involving 113 AYAs aged 11-24 years undergoing myeloablative HSCT .
METHODS	Participants , randomized to the TMV or low-dose control ( audiobooks ) group , completed 6 sessions over 3 weeks with a board-certified music therapist .
METHODS	Variables were based on Haase 's Resilience in Illness Model ( RIM ) .
METHODS	Participants completed measures related to latent variables of illness-related distress , social integration , spiritual perspective , family environment , coping , hope-derived meaning , and resilience at baseline ( T1 ) , postintervention ( T2 ) , and 100 days posttransplant ( T3 ) .
RESULTS	At T2 , the TMV group reported significantly better courageous coping ( Effect Size [ ES ] , 0.505 ; P = .030 ) .
RESULTS	At T3 , the TMV group reported significantly better social integration ( ES , 0.543 ; P = .028 ) and family environment ( ES , 0.663 ; P = .008 ) , as well as moderate nonsignificant effect sizes for spiritual perspective ( ES , 0.450 ; P = .071 ) and self-transcendence ( ES , 0.424 ; P = .088 ) .
CONCLUSIONS	The TMV intervention improves positive health outcomes of courageous coping , social integration , and family environment during a high-risk cancer treatment .
CONCLUSIONS	We recommend the TMV be examined in a broader population of AYAs with high-risk cancers .

###25155371
OBJECTIVE	To report the 12-month results of the first head-to-head comparison of a dexamethasone implant ( Ozurdex ; Allergan , Inc. , Irvine , CA ) versus bevacizumab ( Avastin ; Genentech , South San Francisco , CA ) for center-involving diabetic macular edema ( DME ) .
METHODS	Phase 2 , prospective , multicenter , randomized , single-masked clinical trial ( clinicaltrials.gov identifier NCT01298076 ) .
METHODS	We enrolled 88 eyes of 61 patients with center-involving DME .
METHODS	Forty-two eyes were randomized to receive bevacizumab every 4 weeks and 46 eyes were randomized to receive a dexamethasone implant every 16 weeks , both pro re nata .
METHODS	Results were analyzed using linear regression with generalized estimation equation methods to account for between-eye correlation .
METHODS	The primary outcome was the proportion of eyes that improved vision by 10 logarithm of minimum angle of resolution letters .
METHODS	Secondary outcomes included mean change in best-corrected visual acuity ( BCVA ) , change in central macular thickness ( CMT ) , injection frequency , and adverse events .
METHODS	Patient-reported outcomes were measured using the Impact of Vision Impairment ( IVI ) questionnaire .
RESULTS	Improvement in BCVA of 10 or more letters was found in 17 of 42 eyes ( 40 % ) treated with bevacizumab compared with 19 of 46 dexamethasone implant-treated eyes ( 41 % ; P = 0.83 ) .
RESULTS	None of the 42 bevacizumab eyes lost 10 letters or more , whereas 5 of 46 ( 11 % ) dexamethasone implant eyes did , mostly because of cataract .
RESULTS	Mean CMT decreased by 122 m for bevacizumab eyes and by 187 m for dexamethasone implant eyes ( P = 0.015 ) .
RESULTS	Bevacizumab-treated eyes received a mean of 8.6 injections compared with 2.7 injections for dexamethasone implant eyes .
RESULTS	Significant improvement in IVI scores occurred for both treatment groups .
CONCLUSIONS	Dexamethasone implant achieved similar rates of visual acuity improvement compared with bevacizumab for DME , with superior anatomic outcomes and fewer injections .
CONCLUSIONS	Both treatments were associated with improvement in visual quality-of-life scores .
CONCLUSIONS	However , more dexamethasone implant-treated eyes lost vision , mainly because of cataract .

###25550228
BACKGROUND	As tau aggregation pathology correlates with clinical dementia in Alzheimer 's disease ( AD ) , a tau aggregation inhibitor ( TAI ) could have therapeutic utility .
BACKGROUND	Methylthioninium ( MT ) acts as a selective TAI in vitro and reduces tau pathology in transgenic mouse models .
OBJECTIVE	To determine the minimum safe and effective dose of MT required to prevent disease progression on clinical and functional molecular imaging outcomes .
METHODS	An exploratory double-blind , randomized , placebo-controlled , dose-finding trial of MT ( 69 , 138 , and 228 mg/day ) was conducted in 321 mild/moderate AD subjects .
METHODS	The primary outcome was change on the Alzheimer 's Disease Assessment Scale-cognitive subscale ( ADAS-cog ) at 24 weeks relative to baseline severity .
METHODS	Effect of treatment on regional cerebral blood flow decline was determined in a sub-study in 135 subjects .
METHODS	After 24 weeks , subjects were re-consented to enter sequential 6 - and 12-month blinded extension phases .
METHODS	Registered with ClinicalTrials.gov ( NCT00515333 ) .
RESULTS	At 24 weeks , there were significant treatment benefits in two independent populations at the 138 mg/day dose : in moderate subjects on the ADAS-cog scale ( treatment effect : -5.42 units , corrected p = 0.047 ) and two other clinical scales ; in mild subjects on the more sensitive regional cerebral blood flow measure ( treatment effect : 1.97 % , corrected p < 0.001 ) .
RESULTS	With continued treatment for 50 weeks , benefit was seen on the ADAS-cog scale in both mild and moderate subjects .
RESULTS	The delivery of the highest dose was impaired due to dose-dependent dissolution and absorption limitations .
CONCLUSIONS	The minimum safe and effective daily MT dose is 138 mg and suggests that further study of MT is warranted in AD .

###25190442
OBJECTIVE	Infarct size and location are thought to correlate with different mechanisms of lacunar infarcts .
OBJECTIVE	We examined the relationship between the size and shape of lacunar infarcts and vascular risk factors and outcomes .
METHODS	We studied 1679 participants in the Secondary Prevention of Small Subcortical Stroke trial with a lacunar infarct visualized on diffusion-weighted imaging .
METHODS	Infarct volume was measured planimetrically , and shape was classified based on visual analysis after 3-dimensional reconstruction of axial MRI slices .
RESULTS	Infarct shape was ovoid/spheroid in 63 % , slab in 12 % , stick in 7 % , and multicomponent in 17 % .
RESULTS	Median infarct volume was smallest in ovoid/spheroid relative to other shapes : 0.46 , 0.65 , 0.54 , and 0.90 mL , respectively ( P < 0.001 ) .
RESULTS	Distributions of vascular risk factors were similar across the 4 groups except that patients in the ovoid/spheroid and stick groups were more often diabetic and those with multicomponent had significantly higher blood pressure at study entry .
RESULTS	Intracranial stenosis did not differ among groups ( P = 0.2 ) .
RESULTS	Infarct volume was not associated with vascular risk factors .
RESULTS	Increased volume was associated with worse functional status at baseline and 3 months .
RESULTS	Overall , 162 recurrent strokes occurred during an average of 3.4 years of follow-up with no difference in recurrent ischemic stroke rate by shape or volume .
CONCLUSIONS	In patients with recent lacunar stroke , vascular risk factor profile was similar among the different infarct shapes and sizes .
CONCLUSIONS	Infarct size correlated with worse short-term functional outcome .
CONCLUSIONS	Neither shape nor volume was predictive of stroke recurrence .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00059306 .

###25773566
OBJECTIVE	To develop a model to predict EuroQol five-dimensional questionnaire ( EQ-5D ) values from clinical chronic obstructive pulmonary disease ( COPD ) questionnaire ( CCQ ) scores .
METHODS	We used data from three clinical trials ( the Randomized Clinical Trial on Effectiveness of Integrated COPD Management in Primary Care [ RECODE ] , the Assessment Of Going Home Under Early Assisted Discharge [ GO-AHEAD ] , and the Health Status Guided COPD Care [ MARCH ] ) .
METHODS	Data were randomly split into an estimation sample and a validation sample .
METHODS	The conceptual similarity between patient-reported CCQ and preference-based EQ-5D scores was assessed using correlation and principal-component analysis .
METHODS	Different types of models were estimated with increasing complexity .
METHODS	We selected the final models on the basis of mean absolute error and root mean square error when comparing predicted and observed values from the same population ( internal validity ) and from different trial populations ( external validity ) .
METHODS	We also developed models for different country-specific EQ-5D value sets .
RESULTS	The principal-component analysis showed that the CCQ domains functional state and mental state are associated with four dimensions of the EQ-5D .
RESULTS	The EQ-5D dimension pain/discomfort formed a separate construct on which no CCQ item loaded .
RESULTS	The mean observed EQ-5D values were not significantly different from the mean predicted EQ-5D values in internal validation samples but did significantly differ in external validation samples .
RESULTS	The models underestimated EQ-5D values in milder health states and overestimated them in more severe health states .
RESULTS	The predictive ability of the models was similar across different EQ-5D value sets .
CONCLUSIONS	The models can predict mean EQ-5D values that are similar to observed mean values in a similar population .
CONCLUSIONS	The overestimating/underestimating of the low/high EQ-5D values , however , limits its use in Markov models .
CONCLUSIONS	Therefore , mapping should be used cautiously .

###24506289
OBJECTIVE	To evaluate quetiapine XR in patients with anxious depression , as defined by HAM-A total and HAM-D anxiety/somatisation factor scores .
METHODS	Post hoc analyses of pooled data from two 6-week , double-blind , randomised , placebo-controlled studies of adjunctive quetiapine XR ( 150 or 300 mg/day ) in patients with MDD and inadequate response to antidepressants .
METHODS	Patients were stratified in a primary analysis using HAM-A ( HAM-A total score at baseline 20 [ `` high '' ] or < 20 [ `` low '' ] ) and a secondary analysis using HAM-D ( anxious depression defined as HAM-D anxiety/somatisation factor score 7 ) .
METHODS	Outcomes included change in MADRS total score .
RESULTS	In patients with high anxiety levels ( HAM-A total score 20 ) , reductions in MADRS total score were -15.20 ( P = 0.122 ) and -15.92 ( P < 0.05 ) for quetiapine XR 150 and 300 mg/day , respectively , vs. placebo ( -13.49 ) .
RESULTS	In patients with low levels of anxiety ( HAM-A total score < 20 ) , both quetiapine XR doses ( P < 0.001 ) improved MADRS total scores vs. placebo .
RESULTS	In the secondary analysis , quetiapine XR 150 ( P < 0.01 ) and 300 mg/day ( P < 0.001 ) improved MADRS total score vs. placebo in patients with HAM-D anxiety/somatisation factor score 7 .
CONCLUSIONS	Adjunct quetiapine XR demonstrates efficacy in patients with anxious and non-anxious depression , assessed using HAM-A total score , and anxious depression assessed using HAM-D anxiety/somatisation factor score .

###24365987
BACKGROUND	To develop a population pharmacokinetic model for intravenous omeprazole in critically ill children .
METHODS	One hundred eighty-six omeprazole concentration-time data from 40 critically ill children were analyzed using the nonlinear mixed-effects approach with the nonlinear mixed-effects modeling software , version 7.2 software .
METHODS	Patients were randomized into 2 groups and received intravenous omeprazole at a dose of 0.5 or 1 mg/kg twice daily .
METHODS	Blood samples were drawn at 0.5 , 2 , 6 , 12 , 24 , and 48 hours after the first infusion .
RESULTS	The pharmacokinetic profile was best described by a 2-compartment model with a first-order elimination process .
RESULTS	Between-patient variability could only be associated with plasma clearance ( CL ) .
RESULTS	The typical values for plasma CL were 24.9 Lh70 kg ( 10.08 % ) , with a distributional clearance of 53.9 Lh70 kg ( 11.00 % ) and central and peripheral compartment distribution volumes of 4.23 L/70 kg ( 19.62 % ) and 674 L/70 kg ( 0.89 % ) , respectively .
RESULTS	Allometric size models seemed to predict changes adequately in all the pharmacokinetic parameters .
RESULTS	High values of between-patient variability of CL [ 75.50 % ( 2.60 % ) ] and residual variability [ 130.0 % ( 5.26 % ) ] were still found in the final model .
RESULTS	Model-based simulations suggested that the most suitable dose was 1 mg/kg because this yielded similar exposure ( defined by the area under the concentration-time curve ) to that obtained in adults after a 20-mg dose of omeprazole intravenously .
CONCLUSIONS	An allometric size model allows changes to be predicted in all the pharmacokinetic parameters , making dose adjustment by body weight important to achieve the most effective omeprazole exposure .
CONCLUSIONS	This is the first step toward a population pharmacokinetic study , including more data to develop a predictable model to be used during therapeutic drug monitoring .

###25139606
BACKGROUND	Instructor feedback reduces the number of repetitions and time to reach proficiency during laparoscopic simulator training .
BACKGROUND	The objective of this study was to examine the effect of instructor feedback on long-term skill retention .
METHODS	A 6-month follow-up of a randomized trial .
METHODS	Participants were surgical novices ( medical students ) .
METHODS	All participants ( n = 99 ) initially practiced a laparoscopic salpingectomy on the LapSim virtual reality simulator to proficiency .
METHODS	The intervention group could request instructor feedback , whereas the control group could not .
METHODS	After 6 months , the participants ( n = 65 ) practiced on the simulator until they reached proficiency again .
METHODS	The primary outcomes were the total time and the number of repetitions .
RESULTS	Initially , the intervention group used significantly fewer repetitions ( 29 vs 65 , p < 0.0005 ) and less total training time ( 162 vs 342 min , p < 0.0005 ) than the control group to reach the proficiency level .
RESULTS	At follow-up , both the groups used an equal number of repetitions ( 21 vs 20 , p = 0.72 ) and time ( 83 vs 73 min , p = 0.37 ) to reach the same proficiency level .
CONCLUSIONS	Instructor feedback during proficiency-based laparoscopic simulator training does not affect the long-term retention of skills .

###25546166
OBJECTIVE	To assess the effect of food on the pharmacokinetics ( PK ) of canagliflozin and metformin following administration of a canagliflozin/metformin ( 150/1 ,000 mg ) immediate-release ( IR ) fixed-dose combination ( FDC ) tablet .
METHODS	A randomized , open-label , singlecenter , single-dose , 2-period , 2-sequence crossover study was conducted in healthy participants .
METHODS	Participants were randomized to 2 sequences of fasted and fed ( or vice versa ) administration of one 150/1 ,000 mg canagliflozin/metformin IR FDC , with 10-14 day washout between treatments PK parameters ( AUC , Cmax , tmax , t1/2 ) were assessed for canagliflozin and metformin .
METHODS	Safety was evaluated .
RESULTS	When comparing the IR FDC tablet administered with and without food , PK parameters of canagliflozin were bioequivalent as the 90 % confidence intervals ( CIs ) for log-transformed AUClast , AUC , and Cmax were within the bioequivalence limits of 80-125 % .
RESULTS	For metformin , overall exposure was similar under fed and fasted conditions as geometric mean ratios for AUC and associated 90 % CI were contained within the bioequivalence limits , but geometric mean Cmax decreased by 16 % in the fed compared to fasted state .
RESULTS	Both treatments were well tolerated with similar adverse events and most common were gastrointestinal events , generally attributed to metformin .
CONCLUSIONS	Food did not affect canagliflozin bioavailability parameters ( Cmax and AUCs ) or AUCs of metformin .
CONCLUSIONS	The Cmax of metformin was decreased by 16 % , which is not considered clinically meaningful .
CONCLUSIONS	The canagliflozin/metformin FDC tablet is recommended to be taken with meals to reduce the symptoms of gastrointestinal intolerability associated with metformin .

###25196897
BACKGROUND	Routine prophylaxis with replacement factor VIII ( FVIII ) - the standard of care for severe hemophilia A - often requires frequent intravenous infusions ( three or four times weekly ) .
BACKGROUND	An FVIII molecule with an extended half-life could reduce infusion frequency .
BACKGROUND	The A-LONG study established the safety , efficacy and prolonged pharmacokinetics of recombinant FVIII Fc fusion protein ( rFVIIIFc ) in previously treated adolescents and adults with severe hemophilia A.
OBJECTIVE	In this post hoc analysis , we investigated the relationship between subjects ' prestudy ( FVIII ) and on-study ( rFVIIIFc ) regimens .
METHODS	We analyzed two subgroups of subjects : prior prophylaxis and on-study individualized prophylaxis ( n = 80 ) , and prior episodic treatment and on-study weekly prophylaxis ( n = 16 ) .
METHODS	Subjects ' prestudy dosing regimens and bleeding rates were compared with their final rFVIIIFc regimens and annualized bleeding rates ( ABRs ) in the last 3 months on-study .
METHODS	Dosing regimen simulations based on population pharmacokinetics models for rFVIII and rFVIIIFc were performed .
RESULTS	As compared with their prestudy regimen , 79 of 80 ( 98.8 % ) subjects on individualized rFVIIIFc prophylaxis decreased their infusion frequency .
RESULTS	Overall ABRs were low , with comparable factor consumption .
RESULTS	Longer dosing intervals , including 5-day dosing , were associated with higher baseline von Willebrand factor antigen levels .
RESULTS	Simulated dosing regimens predicted a greater proportion of subjects with steady-state FVIII activity trough levels of 1 IU dL ( -1 ) ( 1 % ) with rFVIIIFc than with equivalent rFVIII regimens .
CONCLUSIONS	These results suggest that patients on rFVIIIFc prophylaxis can reduce their infusion frequency as compared with their prior FVIII regimen while maintaining low bleeding rates , affording more patients trough levels of 1 IU dL ( -1 ) than with rFVIII products requiring more frequent dosing regimens .

###24529259
BACKGROUND	Compared to other children , those with disability have additional challenges to being physically active .
BACKGROUND	Prader-Willi Syndrome is a genetic form of childhood obesity that is characterized by hypotonia , growth hormone deficiency , behavioral , and cognitive disability .
BACKGROUND	In children , the low prevalence of this syndrome ( 1 in 10,000 to 15,000 live births ) makes group-based physical activity interventions difficult .
BACKGROUND	In contrast , the home environment presents a natural venue to establish a physical activity routine for this population .
BACKGROUND	This manuscript describes the design of a parent-led physical activity intervention incorporating playground and interactive console-based games to increase physical activity participation in youth with and without Prader-Willi Syndrome .
METHODS	The study participants will be 115 youth ages 8-15 y ( 45 with the syndrome and 70 without the syndrome but categorized as obese ) .
METHODS	The study will use a parallel design with the control group receiving the intervention after serving as control .
METHODS	Participants will be expected to complete a physical activity curriculum 4 days a week for 6 months including playground games 2 days a week and interactive console games 2 days a week .
METHODS	Parents will be trained at baseline and then provided with a curriculum and equipment to guide their implementation of the program .
METHODS	Tips related to scheduling and coping with barriers to daily program implementation will be provided .
METHODS	Throughout , parents will be contacted by phone once a week ( weeks 1-4 ) and then every other week to receive support in between visits .
METHODS	Measurements of children and parents will be obtained at baseline , 12 weeks , and at the end ( week 24 ) of the intervention .
METHODS	Children main outcomes include physical activity ( accelerometry ) , body composition ( dual x-ray absorptiometry ) , motor proficiency ( Bruininks-Oseretsky Test of Motor Proficiency ) , quality of life and physical activity self-efficacy ( questionnaires ) .
METHODS	Intervention compliance will be monitored using mail-in daily self-report checklists .
CONCLUSIONS	This parent-guided physical activity intervention aims to increase physical activity by using a curriculum that builds physical activity related self-confidence through the development and/or enhancement of motor skill competency .
CONCLUSIONS	Ultimately , helping children develop these skills as well as joy in being physically active will translate into sustained behavior change .
BACKGROUND	Current Controlled Trial : NCT02058342 .

###26050790
BACKGROUND	Exercise started shortly after breast cancer diagnosis might prevent or diminish fatigue complaints .
BACKGROUND	The Physical Activity during Cancer Treatment ( PACT ) study was designed to primarily examine the effects of an 18-week exercise intervention , offered in the daily clinical practice setting and starting within 6 weeks after diagnosis , on preventing an increase in fatigue .
METHODS	This multi-centre controlled trial randomly assigned 204 breast cancer patients to usual care ( n = 102 ) or supervised aerobic and resistance exercise ( n = 102 ) .
METHODS	By design , all patients received chemotherapy between baseline and 18 weeks .
METHODS	Fatigue ( i.e. , primary outcome at 18 weeks ) , quality of life , anxiety , depression , and physical fitness were measured at 18 and 36 weeks .
RESULTS	Intention-to-treat mixed linear model analyses showed that physical fatigue increased significantly less during cancer treatment in the intervention group compared to control ( mean between-group differences at 18 weeks : -1.3 ; 95 % CI -2.5 to -0.1 ; effect size -0.30 ) .
RESULTS	Results for general fatigue were comparable but did not reach statistical significance ( -1.0 , 95 % CI -2.1 ; 0.1 ; effect size -0.23 ) .
RESULTS	At 18 weeks , submaximal cardiorespiratory fitness and several muscle strength tests ( leg extension and flexion ) were significantly higher in the intervention group compared to control , whereas peak oxygen uptake did not differ between groups .
RESULTS	At 36 weeks these differences were no longer statistically significant .
RESULTS	Quality of life outcomes favoured the exercise group but were not significantly different between groups .
CONCLUSIONS	A supervised 18-week exercise programme offered early in routine care during adjuvant breast cancer treatment showed positive effects on physical fatigue , submaximal cardiorespiratory fitness , and muscle strength .
CONCLUSIONS	Exercise early during treatment of breast cancer can be recommended .
CONCLUSIONS	At 36 weeks , these effects were no longer statistically significant .
CONCLUSIONS	This might have been caused by the control participants ' high physical activity levels during follow-up .
BACKGROUND	Current Controlled Trials ISRCTN43801571 , Dutch Trial Register NTR2138 .
BACKGROUND	Trial registered on December 9th , 2009 .

###25010119
OBJECTIVE	In 1993-1994 , a psychosocial intervention conducted in New York City significantly improved outcomes for parents living with HIV and their adolescent children over six years .
OBJECTIVE	We examine if the intervention benefits are similar for adolescents of mothers living with HIV ( MLH ) in 2004-2005 in Los Angeles when MLH 's survival had increased substantially .
METHODS	Adolescents of MLH in Los Angeles ( N = 256 ) aged 12-20 years old were randomized with their MLH to either : 1 ) a standard care condition ( n = 120 adolescent-MLH dyads ) ; or 2 ) an intervention condition consisting of small group activities to build coping skills ( n = 136 adolescent-MLH dyads , 78 % attended the intervention ) .
METHODS	At 18 months , 94.7 % of adolescents were reassessed .
METHODS	Longitudinal structural equation modeling examined if intervention participation impacted adolescents ' relationships with parents and their sexual risk behaviors .
RESULTS	Compared to the standard care , adolescents in the intervention condition reported significantly more positive family bonds 18 months later .
RESULTS	Greater participation by MLH predicted fewer family conflicts , and was indirectly associated with less adolescent sexual risk behavior at the 18 month follow-up assessment .
RESULTS	Anticipated developmental patterns were observed -- sexual risk acts increased with age .
RESULTS	Reports were also consistent with anticipated gender roles ; girls reported better bonds with their mothers at 18 months , compared to boys .
CONCLUSIONS	Adolescents of MLH have better bonds with their mothers as a function of participating in a coping skills intervention and reduced sexual risk-taking as a function of MLH intervention involvement .

###24912398
OBJECTIVE	To assess the effectiveness of supportive counselling after miscarriage .
METHODS	Randomised controlled trial .
METHODS	University hospital .
METHODS	Two hundred and eighty women with miscarriage .
METHODS	Women were randomised to receive supportive counselling from a nurse ( at diagnosis and 2 weeks later ) or routine care .
METHODS	Psychological wellbeing was measured with the General Health Questionnaire ( GHQ-12 ) and Beck Depression Inventory ( BDI ) .
METHODS	Primary outcome measured the proportion of women suffering psychological distress ( GHQ-12 score 4 ) at 3 months after miscarriage .
METHODS	Secondary outcomes were GHQ-12 and BDI scores at 6 weeks , 3 and 6 months .
RESULTS	There was no difference in the proportion of women suffering psychological distress at 3 months after miscarriage ( 17.1 % in counselling group versus 24.4 % in control group ; 95 % CI -0.034 to 0.177 ; P = 0.19 ) .
RESULTS	However , for the subgroup of women ( n = 152 ) with high baseline GHQ-12 scores , the median GHQ-12 score in the counselling group was significantly lower than the control group at 6 weeks ( median score 3 versus 4.5 in counselling and control groups ; P = 0.04 ) and 3 months ( median score 1 versus 2.5 in counselling and control groups ; P = 0.03 ) .
RESULTS	Similarly , for women with high baseline BDI scores ( BDI > 12 ) , the proportion for women continuing to score high was significantly lower in the counselling group 6 weeks after miscarriage ( 33.3 versus 61.1 % in counselling group and control group ; P = 0.03 ) .
CONCLUSIONS	Although the results of current study do not justify routine counselling of all women following miscarriage , a supportive counselling programme for selected women with high levels of psychological distress is promising and merits further investigation .

###24622752
BACKGROUND	The susceptibility to type 2 diabetes of people of south Asian descent is established , but there is little trial-based evidence for interventions to tackle this problem .
BACKGROUND	We assessed a weight control and physical activity intervention in south Asian individuals in the UK .
METHODS	We did this non-blinded trial in two National Health Service ( NHS ) regions in Scotland ( UK ) .
METHODS	Between July 1 , 2007 , and Oct 31 , 2009 , we recruited men and women of Indian and Pakistani origin , aged 35 years or older , with waist circumference 90 cm or greater in men or 80 cm or greater in women , and with impaired glucose tolerance or impaired fasting glucose determined by oral glucose tolerance test .
METHODS	Families were randomised ( using a random number generator program , with permuted blocks of random size , stratified by location [ Edinburgh or Glasgow ] , ethnic group [ Indian or Pakistani ] , and number of participants in the family [ one vs more than one ] ) to intervention or control .
METHODS	Participants in the same family were not randomised separately .
METHODS	The intervention group received 15 visits from a dietitian over 3 years and the control group received four visits in the same period .
METHODS	The primary outcome was weight change at 3 years .
METHODS	Analysis was by modified intention to treat , excluding participants who died or were lost to follow-up .
METHODS	We used linear regression models to provide mean differences in baseline-adjusted weight at 3 years .
METHODS	This trial is registered , number ISRCTN25729565 .
RESULTS	Of 1319 people who were screened with an oral glucose tolerance test , 196 ( 15 % ) had impaired glucose tolerance or impaired fasting glucose and 171 entered the trial .
RESULTS	Participants were in 156 family clusters that were randomised ( 78 families with 85 participants were allocated to intervention ; 78 families with 86 participants were allocated to control ) .
RESULTS	167 ( 98 % ) participants in 152 families completed the trial .
RESULTS	Mean weight loss in the intervention group was 1.13 kg ( SD 4.12 ) , compared with a mean weight gain of 0.51 kg ( 3.65 ) in the control group , an adjusted mean difference of -1.64 kg ( 95 % CI -2.83 to -0.44 ) .
CONCLUSIONS	Modest , medium-term changes in weight are achievable as a component of lifestyle-change strategies , which might control or prevent adiposity-related diseases .
BACKGROUND	National Prevention Research Initiative , NHS Research and Development ; NHS National Services Scotland ; NHS Health Scotland .

###24757668
OBJECTIVE	Neurobiologically , panic disorder ( PD ) is supposed to be characterised by cerebral hypofrontality .
OBJECTIVE	Via functional near-infrared spectroscopy ( fNIRS ) , we investigated whether prefrontal hypoactivity during cognitive tasks in PD-patients compared to healthy controls ( HC ) could be replicated .
OBJECTIVE	As intermittent theta burst stimulation ( iTBS ) modulates cortical activity , we furthermore investigated its ability to normalise prefrontal activation .
METHODS	Forty-four PD-patients , randomised to sham or verum group , received 15 iTBS-sessions above the left dorsolateral prefrontal cortex ( DLPFC ) in addition to psychoeducation .
METHODS	Before first and after last iTBS-treatment , cortical activity during a verbal fluency task was assessed via fNIRS and compared to the results of 23 HC .
RESULTS	At baseline , PD-patients showed hypofrontality including the DLPFC , which differed significantly from activation patterns of HC .
RESULTS	However , verum iTBS did not augment prefrontal fNIRS activation .
RESULTS	Solely after sham iTBS , a significant increase of measured fNIRS activation in the left inferior frontal gyrus ( IFG ) during the phonological task was found .
CONCLUSIONS	Our results support findings that PD is characterised by prefrontal hypoactivation during cognitive performance .
CONCLUSIONS	However , verum iTBS as an `` add-on '' to psychoeducation did not augment prefrontal activity .
CONCLUSIONS	Instead we only found increased fNIRS activation in the left IFG after sham iTBS application .
CONCLUSIONS	Possible reasons including task-related psychophysiological arousal are discussed .

###24556879
OBJECTIVE	To compare the outcomes of phacoemulsification with either a 2.5-mm clear corneal incision and a foldable intraocular lens ( IOL ) or a 5-mm sclerocorneal tunnel incision and a rigid polymethyl methacrylate ( PMMA ) IOL .
METHODS	In a prospective , randomised clinical trial of phacoemulsification cataract surgery , 1200 patients received either a foldable hydrophilic acrylic IOL through a 2.5-mm corneal incision or an inexpensive rigid PMMA IOL via a 5-mm sclerocorneal tunnel .
METHODS	Intra - and post-operative data and visual acuity at discharge , 6 weeks , and 1 year follow-up were analysed .
RESULTS	At 1 year after surgery , 996 ( 83.0 % ) patients were followed up with an uncorrected visual acuity of 6/18 or better in 90.3 % of the foldable and 94.3 % in the rigid IOL group ( risk ratio ( RR ) 0.96 , 95 % confidence intervals ( CI ) 0.92-0 .99 ) .
RESULTS	Poor outcome ( best-corrected acuity 6/60 or worse ) occurred in 1.0 % and 0.4 % , respectively ( RR 4.28 , 95 % CI 0.48-38 .18 ) .
RESULTS	The surgical cost of consumables and overall surgical time were similar in both groups ; however , the cost of the foldable IOL was eight times higher than the PMMA IOL .
RESULTS	Posterior capsule opacification was more common in the rigid IOL group at 12 months ( 36.1 % vs 23.3 % ) ; however , this did not affect post-operative vision .
CONCLUSIONS	In the hands of experienced cataract surgeons , phacoemulsification with implantation of a foldable or a rigid IOL gives excellent results .
CONCLUSIONS	Using an inexpensive rigid PMMA IOL will make phacoemulsification more affordable for poor patients in low - and middle-income countries .

###25238909
OBJECTIVE	Calcium folinate ( leucovorin ) , which is converted in vivo into biologically active folate , enhances the potency of 5-fluorouracil ( 5-FU ) - based chemotherapy in colorectal cancer .
OBJECTIVE	A common dosage of leucovorin in adjuvant and palliative settings is 60mg/m ( 2 ) .
OBJECTIVE	The aim was to determine the levels of tetrahydrofolate ( THF ) , 5,10-methylenetetrahydrofolate ( methyleneTHF ) , and 5-methyltetrahydrofolate ( methylTHF ) in tumour and mucosa of colorectal cancer patients who received different dosages of leucovorin intravenously at time of surgery .
METHODS	Eighty patients scheduled for colorectal resection with indication of colorectal cancer were randomised into four groups to receive leucovorin at 0 , 60 , 200 , or 500mg/m ( 2 ) , respectively .
METHODS	Blood samples were taken 10 and 30min after leucovorin administration .
METHODS	Biopsy samples from tumour and mucosa were collected and snap-frozen at surgery .
METHODS	The levels of THF , methyleneTHF , and methylTHF in tumour and mucosa were assessed by liquid chromatography electrospray ionisation tandem mass spectrometry ( LC-MS/MS ) and the results were related to clinical diagnosis and therapeutic regimens .
RESULTS	The folate levels in tissue revealed extensive inter-individual variability .
RESULTS	The mean methyleneTHF value for the four treatment groups were 880 , 1,769 , 3,024 and 3,723 pmol/gww .
RESULTS	Only half of the patients who received 60mg/m ( 2 ) leucovorin had higher levels of methyleneTHF in tumour than patients who received 0mg/m ( 2 ) leucovorin .
RESULTS	Rectal cancer patients had significantly lower levels of methyleneTHF compared with colon cancer patients .
CONCLUSIONS	There was a large inter-patient variability of tissue folate levels in colorectal cancer patients after supplementation with leucovorin at standardised dosage .
CONCLUSIONS	High leucovorin doses were needed to exceed baseline methyleneTHF values , especially in rectal cancer patients .
CONCLUSIONS	The results indicate that the standardised leucovorin dose may be insufficient to attain the full antitumour effect of 5-FU .
CONCLUSIONS	Further studies are needed to establish whether higher dosage yields a better treatment response .

###25344101
OBJECTIVE	Evaluate baseline factors that may explain the influence of study site on decisional conflict ( DC ) in men from the Personal Patient Profile : Prostate ( P3P ) randomized trial .
METHODS	476 cases from 5 P3P sites were included .
METHODS	Participants completed baseline demographic assessments , 4 subscales of the DC scale at baseline ( uncertainty , informed , values clarity , and support ) , the Expanded Prostate Cancer Index Composite ( short form ) and the State-Trait Anxiety Inventory .
METHODS	Site data regarding typical practices were collected .
METHODS	Linear regressions were used to model the relation between baseline DC scores and study site adjusting for the list of variables .
RESULTS	Baseline decisional uncertainly ( p = 0.001 ) and informed ( p = 0.03 ) subscales were significantly different across sites .
RESULTS	Participant demographic and baseline measures were significantly different ( p < 0.05 ) between sites except for trait anxiety .
RESULTS	We identified participant level factors that explained study site differences at baseline for the decisional uncertainty and values clarity subscales : a preferred treatment choice at study entry , whether the study program was accessed at home vs. in clinic , number of doctors consulted pre-study , working status , state anxiety , information from the media or a health care provider , and perceived knowledge level .
RESULTS	State anxiety was associated with higher DC across all subscales .
CONCLUSIONS	Individual characteristics of men seeking consultation for LPC were associated with DC at baseline , not the site alone ; anxiety contributed to higher conflict .
CONCLUSIONS	These findings will inform future development and implementation of the P3P and other decision support interventions .
BACKGROUND	NCT00692653 .

###25757214
BACKGROUND	An immune function assay shows promise for identifying solid organ recipients at risk for infection or rejection .
BACKGROUND	The following randomized prospective study was designed to assess the clinical benefits of adjusting immunosuppressive therapy in liver recipients based on immune function assay results .
METHODS	Adult liver recipients were randomized to standard practice ( control group ; n = 102 ) or serial immune function testing ( interventional group ; n = 100 ) performed with a commercially available in vitro diagnostic assay ( ImmuKnow ; Viracor-IBT Laboratories , Lee 's Summit , MO ) before transplantation , immediately after surgery and at day 1 , weeks 1 to 4 , 6 , and 8 , and months 3 to 6 , 9 , and 12 .
METHODS	The assay was repeated within 7 days of suspected/confirmed rejection/infection and within 1 week after event resolution .
RESULTS	Based on immune function values , tacrolimus doses were reduced 25 % when values were less than 130 ng/mL adenosine triphosphate ( low immune cell response ) and increased 25 % when values were greater than 450 ng/mL adenosine triphosphate ( strong immune cell response ) .
RESULTS	The 1-year patient survival was significantly higher in the interventional arm ( 95 % vs 82 % ; P < 0.01 ) and the incidence of infections longer than 14 days after transplantation was significantly lower among patients in the interventional arm ( 42.0 % vs. 54.9 % , P < 0.05 ) .
RESULTS	The difference in infection rates was because of lower bacterial ( 32 % vs 46 % ; P < 0.05 ) and fungal infection ( 2 % vs 11 % ; P < 0.05 ) .
RESULTS	Among recipients without adverse events , the study group had lower tacrolimus dosages and blood levels .
CONCLUSIONS	Immune function testing provided additional data which helped optimize immunosuppression and improve patient outcomes .

###25468954
OBJECTIVE	There are scarce reports regarding the prognosis of a second course of antithyroid drug ( ATD ) therapy on recurrent Graves ' disease ( GD ) .
OBJECTIVE	The aim of this study was to assess the long-term remission rate after a second ATD therapy and verify significant clinical predictors of a remission .
METHODS	A prospective randomized clinical trial with long-term follow-up was conducted to evaluate the effects of a second course of ATD therapy .
METHODS	A total of 128 recurrent GD patients who had finished a first regular ATD therapy were enrolled in this study , and prescribed methimazole ( MMI ) treatment with titration regimen .
METHODS	The patients were randomly assigned to two groups when the drug doses were reduced to 2.5 mg daily ( qd ) .
METHODS	Group 1 was discontinued with 2.5 mg qd after about 5 months .
METHODS	Group 2 was continuously reduced to 2.5 mg every other day ( qod ) after 5 months and then discontinued with 2.5 mg qod after about a further 5 months .
METHODS	The patients were followed for 48 months after drug withdrawal .
RESULTS	Of the total number of patients , 97 cases ( 75.78 % ) achieved permanent remission at the end of follow-up , with the recurrence of 31 cases ( 24.22 % ) .
RESULTS	The remission rate of group 2 ( 84.62 % ) was significantly higher than that of group 1 ( 66.67 % ) ( P = 0.024 ) .
RESULTS	Cox regression showed that the hazard ratio for recurrence decreased under a high or high normal TSH level at drug withdrawal .
CONCLUSIONS	A second course of ATD therapy can bring about a satisfying long-term remission on recurrent GD .
CONCLUSIONS	The drug dose of 2.5 mg qod and a high or high normal TSH level at drug withdrawal may increase the likelihood of permanent remission .

###25193008
BACKGROUND	Kidney stones are one of the most common disorders of the urinary tract and cause a great deal of morbidity and economic loss .
BACKGROUND	Because of the side effects and costs of current interventional procedures , researchers are interested in finding medicinal therapies .
BACKGROUND	In this regard , some reports have focused on traditional medicines as a drug discovery resource .
BACKGROUND	Iranian scholars in the medieval era recommended Lapis judaicus for the prevention and treatment of kidney stones .
BACKGROUND	The present study assessed the efficacy and safety of Lapis judaicus on the size of calcium kidney stones and some related biochemical factors in blood and urine .
METHODS	Sixty patients with kidney stone disease were included in this double-blind randomized clinical study .
METHODS	Thirty patients received 2g of Lapis judaicus powder in hard capsules per day for 10 weeks , and another 30 patients received a placebo for the same period .
METHODS	Ultrasonography was performed on patients , and blood and urine samples were collected before and after the study to evaluate the efficacy and safety of Lapis judaicus in calcium kidney stone patients .
RESULTS	The size of the kidney stones was reduced significantly ( p < 0.001 ) in the drug group .
RESULTS	In 9 patients from the drug group , the stone was completely dissolved .
RESULTS	Moreover , urine calcium concentration and specific gravity were reduced and urine magnesium was increased ( p < 0.05 ) .
RESULTS	Lapis judaicus did not affect BUN , creatinine , ALT , or AST .
CONCLUSIONS	Contrary to the placebo group , the size of kidney stones was reduced significantly in the treatment group after oral administration of Lapis judaicus .
CONCLUSIONS	This preliminary study confirms traditional knowledge of the efficacy and safety of Lapis judaicus in kidney stone diseases and suggests a new method to treat calcium kidney stones .
CONCLUSIONS	Further detailed in vitro and in vivo studies aimed at discovering the mechanism of action of Lapis judaicus and clinical studies involving a larger population of patients will be necessary to fully explain and confirm the results obtained in the present study .

###24267728
BACKGROUND	Hydration with topical emollients forms the backbone of treatment for mild atopic dermatitis ( AD ) , but few randomized controlled trials have assessed their efficacy in young children .
OBJECTIVE	Assess the efficacy and tolerability of long-term emollient therapy in the treatment of moderate to severe xerosis in young children with AD .
METHODS	This was a phase III , multicentre , double-blind , randomized , vehicle-controlled trial .
METHODS	Children ( n = 251 ) aged 2-6years with AD-associated xerosis were randomized 1:1 to a 28-day treatment with an emollient combining glycerol and paraffin or its vehicle .
METHODS	Non-responders at the end of the double-blind period were treated open label with emollient until day 84 .
METHODS	Responders stopped treatment until reassessment on day 56 .
METHODS	Those who relapsed after stopping treatment were treated open label with emollient until day 84 .
RESULTS	During the double-blind period , xerosis score ( XS ) of the scoring atopic dermatitis ( SCORAD ) index , objective SCORAD and visual analogue score decreased and skin hydration increased more in the emollient group than in the vehicle group ( P < 0.001 for all measures ) .
RESULTS	More patients were responders with emollient than with vehicle ( 66.1 % vs. 45.6 % , P < 0.001 ) .
RESULTS	During the open-label period , stopping emollient treatment led to relapse but improvement returned if treatment was restarted with emollient .
RESULTS	Regular use of the emollient also yielded improvement in children who did not initially respond .
RESULTS	Adverse events were similar in the two groups , and no treatment-related severe adverse events were reported .
CONCLUSIONS	Long-term therapy with emollient is effective and well tolerated for the treatment of xerosis in children with atopic dermatitis .

###24844611
OBJECTIVE	Adequate calcium intakes may enhance bone mineral accumulation during childhood .
OBJECTIVE	Little is known about the optimal calcium intake in Chinese adolescents .
OBJECTIVE	We examined the effects of three levels of calcium intake on bone mineral accretion in adolescents .
METHODS	This was a 2-year randomized , double-blind , controlled trial .
METHODS	The subjects were randomly assigned to receive 40 g of milk powder containing 300 mg of calcium and 200 IU of vitamin D ( Low-Ca group ) , or same milk powder additionally fortified with 300 mg of calcium ( Mid-Ca group ) or 600 mg of calcium ( High-Ca group ) for 2 years .
METHODS	The subjects ' bone mineral density ( BMD ) and bone mineral content ( BMC ) at the total body , lumbar spine and left hip were determined by dual-energy X-ray absorptiometry at baseline and after the second year of treatment .
METHODS	Of the 111 girls and 109 boys ( aged 12-14 years ) enrolled , 91 girls and 91 boys completed the trial .
RESULTS	The girls in the High-Ca group ( 1,110 mg/d ) had 2.3 % , 2.7 % and 2.6 % greater BMD accretion at the total hip , femoral neck and shaft ( P < 0.05 ) but not at total body less head and spine than those in the Low-Ca group ( 655 mg/d ) .
RESULTS	A significant effect of higher calcium intake was also observed for percentage change of size-adjusted BMC at femur neck ( P = 0.047 ) .
RESULTS	Bonferroni tests indicated no significant differences in the percentage changes in BMD , BMC or size-adjusted BMC between the Mid - and Low-Ca groups and between the High - and Mid-Ca groups .
RESULTS	Extra calcium had no observable additional effect in the boys ( P > 0.05 ) .
CONCLUSIONS	An intake of 1000 mg/d or more might be helpful in maximizing bone mineral accretion in the hip for girls .
CONCLUSIONS	But further large studies are required to identify its long-term effects and the optimal calcium intake for boys .

###24256450
BACKGROUND	Acute musculoskeletal trauma , including strains , sprains or contusions , occur frequently .
BACKGROUND	Pain management is a crucial component of treatment .
BACKGROUND	However , there is no convincing evidence which drug is superior in managing pain in these patients .
BACKGROUND	The aim of the PanAM Study is to compare analgesic efficacy of three strategies of pain management : paracetamol , diclofenac , or a combination of both in patients with acute musculoskeletal trauma .
METHODS	The PanAM Study is a multi-center , double blind randomized controlled trial with non-inferiority design .
METHODS	Included are adult patients presenting to an academic , urban Emergency Department or to a General Practice with acute , blunt , traumatic limb injury .
METHODS	In total , 547 patients will be included using a predefined list of exclusion criteria , to be allocated by randomization to treatment with paracetamol + placebo diclofenac , diclofenac + placebo paracetamol or paracetamol + diclofenac .
METHODS	The hypothesis is that paracetamol will not be inferior to treatment with diclofenac , or the combination of both .
METHODS	Primary outcome will be between-group differences in decrease in pain , measured with Numerical Rating Scales at baseline and at 90minutes after study drug administration .
METHODS	Secondary outcomes are Numerical Rating Scales at 30 and 60minutes and measured frequently during three consecutive days after discharge ; occurrence of adverse effects ; patient satisfaction and an analysis of quality of life and cost-effectiveness .
METHODS	Recruitment started July 2013 and is expected to last a year .
CONCLUSIONS	With this multi-center randomized clinical trial we will investigate whether treatment with paracetamol alone is not inferior to diclofenac alone or a combination of both drugs in adult patients with acute musculoskeletal trauma .
CONCLUSIONS	The main relevance of the trial is to demonstrate the benefits and risks of three commonly used treatment regimens for musculoskeletal trauma .
CONCLUSIONS	Data that lead to the prevention of severe Non-Steroidal Anti-Inflammatory Drugs-related adverse effects might be gathered .
BACKGROUND	Dutch Trial Register ( http://www.trialregister.nl ) : NTR3982.EudraCT database ( http://www.clinicaltrialsregister.eu ) : 201300038111 .

###25882987
BACKGROUND	Nilotinib inhibits the tyrosine kinase activity of ABL1/BCR-ABL 1 and KIT , platelet-derived growth factor receptors ( PDGFRs ) , and the discoidin domain receptor .
BACKGROUND	Gain-of-function mutations in KIT or PDGFR are key drivers in most gastrointestinal stromal tumours ( GISTs ) .
BACKGROUND	This trial was designed to test the efficacy and safety of nilotinib versus imatinib as first-line therapy for patients with advanced GISTs .
METHODS	In this randomised , open-label , multicentre , phase 3 trial ( ENESTg1 ) , participants from academic centres were aged 18 years or older and had previously untreated , histologically confirmed , metastatic or unresectable GISTs .
METHODS	Patients were stratified by previous adjuvant therapy and randomly assigned ( 1:1 ) via a randomisation list to receive oral imatinib 400 mg once daily or oral nilotinib 400 mg twice daily .
METHODS	The primary endpoint was centrally reviewed progression-free survival .
METHODS	Efficacy endpoints were assessed by intention-to-treat .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00785785 .
RESULTS	Because the futility boundary was crossed at a preplanned interim analysis , trial accrual terminated in April , 2011 .
RESULTS	Between March 16 , 2009 , and April 21 , 2011 , 647 patients were enrolled ; of whom 324 were allocated nilotinib and 320 were allocated imatinib .
RESULTS	At final analysis of the core study ( data cutoff , October , 2012 ) , 2-year progression-free survival was higher in the imatinib group ( 592 % [ 95 % CI 509-665 ] ) than in the nilotinib group ( 516 % [ 430-595 ] ; hazard ratio 147 [ 95 % CI 110-195 ] ) .
RESULTS	In the imatinib group , the most common grade 3-4 adverse events were hypophosphataemia ( 19 [ 6 % ] ) , anaemia ( 17 [ 5 % ] ) , abdominal pain ( 13 ; 4 % ) , and elevated lipase level ( 15 ; 5 % ) , and in the nilotinib group were anaemia ( 18 ; 6 % ) , elevated lipase level ( 15 ; 5 % ) , elevated alanine aminotransferase concentration ( 12 ; 4 % ) , and abdominal pain ( 11 ; 3 % ) .
RESULTS	The most common serious adverse event in both groups was abdominal pain ( 11 [ 4 % ] in the imatinib group , 14 [ 4 % ] in the nilotinib group ) .
CONCLUSIONS	Nilotinib can not be recommended for broad use to treat first-line GIST .
CONCLUSIONS	However , future studies might identify patient subsets for whom first-line nilotinib could be of clinical benefit .
BACKGROUND	Novartis Pharmaceuticals .

###25307297
OBJECTIVE	To examine the health-related quality of life ( HRQOL ) in patients with transient ischemic attack ( TIA ) or minor stroke and assess the impact of recurrent stroke on HRQOL .
METHODS	Health-related quality of life data on patients participated in the Clopidogrel in High-risk patients with Acute Nondisabling Cerebrovascular Events ( CHANCE ) trial were analyzed .
METHODS	The available 90-day EuroQoL data ( EQ-5D ) were used to calculate EQ-5D index score .
METHODS	Poor HRQOL was defined as an EQ-5D index score 0.5 .
METHODS	The characteristics of HRQOL and factors predicting poor HRQOL in these patients were then explored .
RESULTS	Among the total 5170 patients enrolled , 90-day HRQOL data were obtained from 5104 patients for analysis .
RESULTS	The mean EQ-5D index score at day 90 was 0.88 0.21 for all patients , but only 0.42 0.35 for those with recurrent strokes .
RESULTS	Poor 90-day HRQOL was found in 294 ( 5.8 % ) patients .
RESULTS	Patients with poor HRQOL had more strokes during follow-up than patients with good HRQOL ( 94.9 vs. 4.7 % , P < 0.001 ) .
RESULTS	Age , history of hypertension and diabetes , and NIHSS at baseline were independent risk factors for predicting poor HRQOL .
RESULTS	Stroke recurrence , NIHSS at baseline , age , and minor stroke on admission became independent risk factors once stroke recurrence was added into the model .
CONCLUSIONS	Stroke recurrence was associated with poor HRQOL in patients with TIA or minor strokes .
CONCLUSIONS	Interventions focusing on controlling risk factors and prevention of worsening of neurological function may prevent poor HRQOL in these patients .

###25133177
OBJECTIVE	Comparing the effectivity of prilocaine and prilocaine alkalinized with 8.4 % NaHCO3 in terms of sensory and motor block onset and termination durations in RIVA technique considering patients ' satisfaction and tolerance with application of tourniquet undergoing hand-wrist surgery .
METHODS	64 patients were randomised into two groups .
METHODS	First group ( Group P ) was administered prilocaine and second group ( Group PN ) was administered prilocaine + % 8.4 NaHCO3 .
METHODS	Sensory and motor block onset and termination times and onset of tourniquet pain were recorded .
RESULTS	No significant difference was found between the two groups in terms of onset and termination of sensory block and the onset of motor block .
RESULTS	The duration of the motor block was longer in Group PN than in Group P ( P < 0.05 ) .
RESULTS	Tourniquet pain was more intense in Group P ( P = 0.036 ) .
RESULTS	In Group PN , the use of additional drugs was recorded at a lower rate and patients ' satisfaction was higher than Group P.
CONCLUSIONS	In the present study , it was established that alkalinization of prilocaine had no effect on the duration of sensory block and it prolonged the duration of motor block , increased patients ' satisfaction , and decreased tourniquet pain .
CONCLUSIONS	It is our suggestion that future studies should be carried out on the issue by using different volumes .

###24685998
BACKGROUND	African Americans ( AAs ) experience higher age-adjusted morbidity and mortality than Whites for cardiovascular disease ( CVD ) .
BACKGROUND	Church-based health programs can reduce risk factors for CVD , including elevated blood pressure [ BP ] , excess body weight , sedentary lifestyle and diet .
BACKGROUND	Yet few studies have incorporated older adults and longitudinal designs .
OBJECTIVE	The aims of this study are to : a ) describe a theory-driven longitudinal intervention study to reduce CVD risk in mid-life and older AAs ; b ) compare selected dietary ( fruit and vegetable servings/day , fat consumption ) , physical activity ( PA ) and clinical variables ( BMI , girth circumferences , systolic and diastolic BP , LDL , HDL , total cholesterol [ CHOL ] and HDL/CHOL ) between treatment and comparison churches at baseline ; c ) identify selected background characteristics ( life satisfaction , social support , age , gender , educational level , marital status , living arrangement and medication use ) at baseline that may confound results ; and d ) share the lessons learned .
METHODS	This study incorporated a longitudinal pre/post with comparison group quasi-experimental design .
METHODS	Community-based participatory research ( CBPR ) was used to discover ideas for the study , identify community advisors , recruit churches ( three treatment , three comparison ) in two-counties in North Florida , and randomly select 221 mid-life and older AAs ( 45 + ) ( n = 104 in clinical subsample ) , stratifying for age and gender .
METHODS	Data were collected through self-report questionnaires and clinical assessments .
CONCLUSIONS	Dietary , PA and clinical results were similar to the literature .
CONCLUSIONS	Treatment and comparison groups were similar in background characteristics and health behaviors but differed in selected clinical factors .
CONCLUSIONS	For the total sample , relationships were noted for most of the background characteristics .
CONCLUSIONS	Lessons learned focused on community relationships and participant recruitment .

###24462657
BACKGROUND	Echocardiography-guided ( EG ) left ventricular ( LV ) lead placement at the site of latest mechanical activation improves outcome in heart failure ( HF ) patients receiving a cardiac resynchronization therapy ( CRT ) - defibrillator ( CRT-D ) .
OBJECTIVE	The purpose of this study was to examine the effect of a strategy of EG LV lead placement in each of ischemic ( ICM ) vs nonischemic ( NICM ) cardiomyopathy patients .
METHODS	Patients enrolled in the Speckle Tracking Assisted Resynchronization Therapy for Electrode Region ( STARTER ) prospective , randomized trial who were treated with a CRT-D device ( 108 EG strategy and 75 routine strategy ) were followed to the end-points of death , appropriate CRT-D therapy , or HF hospitalization .
RESULTS	Of the patients enrolled in STARTER , 115 had ICM and 68 had NICM .
RESULTS	Over mean follow-up of 3.7 2.1 years , 62 patients died , 40 received appropriate CRT-D therapy , and 67 had HF hospitalizations .
RESULTS	Compared to NICM patients , patients with ICM had worse survival ( P = .0003 ) , worse survival free from implantable cardioverter-defibrillator therapy ( P = .004 ) , and survival free from HF hospitalization ( P = .0001 ) .
RESULTS	A strategy of EG LV lead placement improved the outcome of CRT-D therapy-free survival primarily in ICM patients and the outcome of HF hospitalization-free survival in both ICM and NICM patients .
RESULTS	Achieving LV resynchronization was most critical in ICM patients in whom arrhythmic and HF outcomes improve with resynchronization to levels comparable to those of NICM patients .
CONCLUSIONS	A strategy of EG LV lead placement improves HF-free survival equally in ICM and NICM patients and CRT-D therapy-free survival more favorably in ICM patients to levels comparable to those of NICM patients .

###24263324
OBJECTIVE	Determine the efficacy of 3 brief intervention strategies that address heavy drinking among injured patients .
BACKGROUND	The content or structure of brief interventions most effective at reducing alcohol misuse after traumatic injury is not known .
METHODS	Injured patients from 3 trauma centers were screened for heavy drinking and randomly assigned to brief advice ( n = 200 ) , brief motivational intervention ( BMI ) ( n = 203 ) , or BMI plus a telephone booster using personalized feedback or BMI + B ( n = 193 ) .
METHODS	Among those randomly assigned , 57 % met criteria for moderate to severe alcohol problems .
METHODS	The primary drinking outcomes were assessed at 3 , 6 , and 12 months .
RESULTS	Compared with brief advice and BMI , BMI + B showed significant reductions in the number of standard drinks consumed per week at 3 ( adjusted means : -1.22 , 95 % confidence interval [ CI ] : -0.99 , approximately -1.49 , P = 0.01 ) and 6 months ( adjusted means : -1.42 , 95 % CI : -1.14 , approximately -1.76 , P = 0.02 ) , percent days of heavy drinking at 6 months ( adjusted means : -5.90 , 95 % CI : -11.40 , approximately -0.40 , P = 0.04 ) , maximum number of standard drinks consumed in 1 day at 3 ( adjusted means : -1.38 , 95 % CI : -1.18 , approximately -1.62 , P = 0.003 ) and 12 months ( adjusted means : -1.71 , 95 % CI : -1.47 , approximately -1.99 , P = 0.02 ) , and number of standard drinks consumed per drinking day at 3 ( adjusted means : -1.49 , 95 % CI : -1.35 , approximately -1.65 , P = 0.002 ) and 6 months ( adjusted means : -1.28 , 95 % CI : -1.17 , approximately -1.40 , P = 0.01 ) .
CONCLUSIONS	Brief interventions based on motivational interviewing with a telephone booster using personalized feedback were most effective at achieving reductions in alcohol intake across the 3 trauma centers .

###24553886
BACKGROUND	The optimal treatment for displaced intra-articular fractures of the calcaneus remains controversial .
BACKGROUND	This study aims to assess the clinical outcomes of a minimally invasive longitudinal approach compared with the sinus tarsi approach in the surgical treatment of these fractures .
METHODS	Patients with a displaced intra-articular fracture of the calcaneus who were admitted to the trauma center of our hospital from September 2009 through April 2010 were randomly assigned to treatment using one of these two surgical techniques .
METHODS	All patients underwent the same standardized postoperative rehabilitation protocol .
METHODS	Functional outcome was assessed by using the American Orthopaedic Foot & Ankle Society scores .
METHODS	Linear regression analysis was performed to identify the potential influencing factors for functional outcomes .
RESULTS	One hundred and sixty-seven patients who met the inclusion criteria were included in the study .
RESULTS	Thirty-seven patients were lost to follow-up for various reasons , and the remaining 130 patients were followed for an average of twenty-seven months .
RESULTS	Sixty-nine fractures in sixty-three patients were treated using a minimally invasive longitudinal approach ( the MILA group ) , and seventy-two feet in sixty-seven patients were treated with a sinus tarsi approach ( the STA group ) .
RESULTS	The two groups were comparable in terms of age , sex , fracture type , and time from injury to operation .
RESULTS	The operative time in the MILA group was significantly shorter than that in STA group ( p < 0.05 ) .
RESULTS	Wound-healing complications were 2.9 % in the MILA group and 12.5 % in the STA group .
RESULTS	The average time to the start of progressive weight-bearing exercise was 5.3 weeks in the MILA group and 5.6 weeks in the STA group ( p > 0.05 ) .
RESULTS	The good and excellent results in the two groups were comparable for the Sanders type-II and III calcaneal fractures ( p > 0.05 ) , but the good to excellent rate in the STA group was significantly higher for the Sanders type-IV fractures ( p < 0.05 ) .
RESULTS	Linear regression analysis showed that surgical technique , Sanders classification , and the time to the start of weight-bearing activity have a significant influence on functional outcomes .
CONCLUSIONS	Outcomes are similar for the minimally invasive longitudinal and sinus tarsi surgical approaches in the treatment of Sanders type-II and III displaced intra-articular fractures of the calcaneus , with the benefit of a lower complication rate and shorter operative time for the minimally invasive technique .
CONCLUSIONS	For Sanders type-IV fractures , however , the sinus tarsi approach appears to be the treatment of choice .

###25231953
BACKGROUND	The BOLERO-2 study previously demonstrated that adding everolimus ( EVE ) to exemestane ( EXE ) significantly improved progression-free survival ( PFS ) by more than twofold in patients with hormone-receptor-positive ( HR ( + ) ) , HER2-negative advanced breast cancer that recurred or progressed during/after treatment with nonsteroidal aromatase inhibitors ( NSAIs ) .
BACKGROUND	The overall survival ( OS ) analysis is presented here .
METHODS	BOLERO-2 is a phase III , double-blind , randomized international trial comparing EVE 10 mg/day plus EXE 25 mg/day versus placebo ( PBO ) + EXE 25 mg/day in postmenopausal women with HR ( + ) advanced breast cancer with prior exposure to NSAIs .
METHODS	The primary end point was PFS by local investigator assessment ; OS was a key secondary end point .
RESULTS	At the time of data cutoff ( 3 October 2013 ) , 410 deaths had occurred and 13 patients remained on treatment .
RESULTS	Median OS in patients receiving EVE + EXE was 31.0 months [ 95 % confidence interval ( CI ) 28.0-34 .6 months ] compared with 26.6 months ( 95 % CI 22.6-33 .1 months ) in patients receiving PBO + EXE ( hazard ratio = 0.89 ; 95 % CI 0.73-1 .10 ; log-rank P = 0.14 ) .
RESULTS	Poststudy treatments were received by 84 % of patients in the EVE + EXE arm versus 90 % of patients in the PBO + EXE arm .
RESULTS	Types of poststudy therapies were balanced across arms , except for chemotherapy ( 53 % EVE + EXE versus 63 % PBO + EXE ) .
RESULTS	No new safety concerns were identified .
CONCLUSIONS	In BOLERO-2 , adding EVE to EXE did not confer a statistically significant improvement in the secondary end point OS despite producing a clinically meaningful and statistically significant improvement in the primary end point , PFS ( 4.6-months prolongation in median PFS ; P < 0.0001 ) .
CONCLUSIONS	Ongoing translational research should further refine the benefit of mTOR inhibition and related pathways in this treatment setting .
BACKGROUND	NCT00863655 .

###25122437
BACKGROUND	ATLAS compared bevacizumab plus erlotinib ( B+E ) with bevacizumab plus placebo ( B+P ) as maintenance therapy after first-line bevacizumab plus chemotherapy ( B+C ) for advanced non-small-cell lung cancer ( NSCLC ) .
BACKGROUND	Prespecified biomarkers were prospectively evaluated .
METHODS	Tumor samples were analyzed for : epidermal growth factor receptor ( EGFR ) expression ( immunohistochemistry [ IHC ] ) ; EGFR gene copy number ( fluorescence in-situ hybridization [ FISH ] ) ; EGFR mutations ( exon 19 deletions/L858R mutations ) ; and KRAS mutations ( exons 2/3 ) .
METHODS	Progression-free survival ( PFS ) and overall survival ( OS ) were estimated .
RESULTS	Of 743 patients randomized to receive maintenance treatment ( after four cycles of B+C without progression ) , 190 ( B+E ) and 177 ( B+P ) were evaluable for biomarker status .
RESULTS	Median PFS ( from randomization ) was 4.4 months ( B+E ) versus 3.7 months ( B+P ; hazard ratio [ HR ] , 0.75 ; 95 % confidence interval [ CI ] , 0.57-0 .99 ) , which was numerically similar to the intent-to-treat PFS .
RESULTS	PFS benefit of B+E was observed across most biomarker subgroups .
RESULTS	EGFR IHC , EGFR FISH , and EGFR/KRAS mutation status were not predictive of outcome .
RESULTS	B+E - treated patients with EGFR mutation-positive NSCLC had longer PFS compared with B+P - treated patients ( HR , 0.44 ; 95 % CI , 0.22-0 .86 ; p = 0.0139 ) .
RESULTS	Patients with KRAS wild-type disease had significant PFS improvements with B+E , compared with B+P ( HR , 0.66 ; 95 % CI , 0.485-0 .914 ; p = 0.0105 ) .
RESULTS	No OS benefit of B+E was observed .
CONCLUSIONS	Patients with KRAS wild-type or EGFR mutation-positive NSCLC derived PFS benefits from B+E .
CONCLUSIONS	However , EGFR IHC , EGFR FISH , and EGFR or KRAS mutation status were not strongly predictive of survival .
CONCLUSIONS	A larger sample size would be needed to confirm the initial trends observed in this study .

###25799793
BACKGROUND	In light of the lately changes in regulations regarding teeth whitening in Europe , the use of 6 % hydrogen peroxide using a dedicated device becomes the first choice treatment option .
BACKGROUND	The purpose of this controlled , randomized , parallel , blinded six months prospective study was to compare this method of teeth whitening treatment with that of in-office method using 35 % hydrogen peroxide .
METHODS	75 healthy american individuals , ages 18-62 , participated in this study .
METHODS	The participants were divided into 3 groups : a 6 % hydrogenperoxide group , a 35 % hydrogen peroxide group and a placebo control group .
METHODS	Whitening procedures were performed on intact frontal teeth with color shade of A3 or higher .
METHODS	A controlled color measurement was performed before , immediately after , three and six months post treatment .
METHODS	Clinical periodontal indices , oral mucosa changes , side effects and participant satisfaction , were recorded .
RESULTS	In the 6 % group , the change in color shades immediately after treatment , three and six months after treatment were 2.37 , 2.17 and 1.95 , respectively .
RESULTS	Tooth color changes in 35 % group immediately after completion of treatment , three and six months after treatment were 3.68 , 2.60 and 1.70 , respectively .
RESULTS	Statistical significant differences were found in both treatment groups between the baseline color shade and the post treatment color shade .
RESULTS	The results were stable three and six months after treatment .
RESULTS	Statistically significant difference between the groups immediately after treatment ( p < 0.0001 ) .
RESULTS	No statistically significant difference was found between the two groups three and six months after treatment ( p > 0.5000 ) .
RESULTS	Side effects such as oral mucosa irritation , burns or sensitive teeth were mild and resolved without intervention .
RESULTS	A high satisfaction level was recorded .
CONCLUSIONS	Tooth color shade can be substantially improved using a dedicated device with 6 % hydrogen peroxide only .
CONCLUSIONS	This whitening method can be helpful for the dentist in : home continuing treatment post in - office whitening specially in case with severe staining , maintenance of in-office whitening treatment outcomes or as an OTC home whitening procedure for patients with limmited budget .

###25831600
OBJECTIVE	Commercialized cetylpyridinium chloride ( CPC ) mouthrinses were compared for antimicrobial substantivity/bioavailability in an in vitro disk retention assay ( DRA ) and clinical antimicrobial activity in vivo in the plaque glycolysis and regrowth method ( PGRM ) .
METHODS	Formulations compared in this testing included commercially available CPC mouthrinses : Crest Pro Health ( CPH ) , ( containing 700 ppm formulated CPC ) ; Colgate Total Puerto Rico ( CT450 ) , ( containing 450 ppm formulated CPC ) ; Colgate Total US ( CT750 ) , ( containing 750 ppm formulated CPC ) ; and Scope Mouthwash ( SCP ) , ( containing 450 ppm formulated CPC ) .
METHODS	A water control ( CTR ) was included in one of the PGRM clinical trials .
METHODS	Two separate clinical PGRM studies employed a controlled , double-blind , randomized , crossover design where qualified adult PGRM panelists were supplied with acclimation NaF dentifrice for use throughout the trials .
METHODS	On treatment days , subjects sampled baseline plaque and then rinsed with assigned mouthrinse following morning toothbrushing .
METHODS	Treated plaque samples were collected 15 and 45 minutes after rinsing .
METHODS	Sampled plaques were vortexed , normalized for biomass and incubated under standard conditions to assess glycolysis .
METHODS	pH response of treated plaques in incubation buffers were compared to baseline untreated plaque values and an Area Under Curve ( AUC ) composite/aggregate analysis of glycolysis inhibition was used for treatment comparisons .
METHODS	A laboratory disk retention substantivity/bioavailability assay measured adsorption affinity of CPC in mouthrinse for anionic cellulose disks in vitro .
RESULTS	Clinical PGRM studies showed significant differences in antibacterial clinical efficacy of commercialized mouthrinses .
RESULTS	Combining clinical study results reveals rank ordered efficacy CPH > CT750 > SCP > CT450 > CTR .
RESULTS	Comparison of DRA to PGRM glycolysis showed a linear relation highlighting correlation of CPC bioavailability to clinical antimicrobial performance of CPC mouthrinses .

###25099872
BACKGROUND	Problem drinking , particularly risky single-occasion drinking is widespread among adolescents and young adults in most Western countries .
BACKGROUND	Mobile phone text messaging allows a proactive and cost-effective delivery of short messages at any time and place and allows the delivery of individualised information at times when young people typically drink alcohol .
BACKGROUND	The main objective of the planned study is to test the efficacy of a combined web - and text messaging-based intervention to reduce problem drinking in young people with heterogeneous educational level .
METHODS	A two-arm cluster-randomised controlled trial with one follow-up assessment after 6 months will be conducted to test the efficacy of the intervention in comparison to assessment only .
METHODS	The fully-automated intervention program will provide an online feedback based on the social norms approach as well as individually tailored mobile phone text messages to stimulate ( 1 ) positive outcome expectations to drink within low-risk limits , ( 2 ) self-efficacy to resist alcohol and ( 3 ) planning processes to translate intentions to resist alcohol into action .
METHODS	Program participants will receive up to two weekly text messages over a time period of 3 months .
METHODS	Study participants will be 934 students from approximately 93 upper secondary and vocational schools in Switzerland .
METHODS	Main outcome criterion will be risky single-occasion drinking in the past 30 days preceding the follow-up assessment .
CONCLUSIONS	This is the first study testing the efficacy of a combined web - and text messaging-based intervention to reduce problem drinking in young people .
CONCLUSIONS	Given that this intervention approach proves to be effective , it could be easily implemented in various settings , and it could reach large numbers of young people in a cost-effective way .
BACKGROUND	Current Controlled Trials ISRCTN59944705 .

###24604886
METHODS	Inflammatory status can increase the risk of adverse cardiovascular events linked to platelet activity and involvement of microparticles ( MP ) released from platelets ( PMP ) , leukocytes ( LMP ) , and monocytes ( MMP ) .
METHODS	These MP carry host cell-derived antigens that may act as markers of metabolic health .
METHODS	Subjects newly diagnosed with type 2 diabetes are offered appropriate standard dietary advice ( SDA ) but this may not be optimal as specific inclusion of other nutrients , such as oats , may add benefit .
METHODS	The effectiveness of such interventions can be tested by examination of MP activation markers .
RESULTS	Subjects ( n = 22 ) with type 2 diabetes participated in a randomized cross-over trial involving 8 wk interventions with either an oat-enriched diet ( OAT ) or following reinforced SDA .
RESULTS	Responses were also compared with preintervention habitual ( HAB ) intake .
RESULTS	OAT reduced the concentrations and proportions of fibrinogen - and tissue factor-related PMP and MMP_11b .
RESULTS	The main effect of SDA was to reduce fibrinogen-activated PMP .
RESULTS	Regardless of chronic intake , a healthy test meal led to postprandial declines in total PMP as well as tissue factor - , fibrinogen - , and P-selectin-positive PMP .
CONCLUSIONS	OAT improved risk factors assessed by MP status , even in subjects with type 2 diabetes already well-controlled by diet and life-style alone .

###24944054
BACKGROUND	Higher whole-grain ( WG ) intake is associated with a lower prevalence of metabolic syndrome ( MetS ) ; however , there is inconsistent clinical evidence with regard to the benefit of WGs compared with refined grains ( RGs ) on MetS .
OBJECTIVE	We hypothesized that consuming WGs in the place of RGs would improve MetS criteria in individuals with or at risk of MetS .
METHODS	A randomized , controlled , open-label parallel study was conducted in 50 overweight and obese individuals with increased waist circumference and one or more other MetS criteria .
METHODS	Participants consumed a controlled weight-loss diet containing either WG or RG ( control ) products for 12 wk .
METHODS	Body composition , MetS criteria and related markers , and plasma alkylresorcinols ( compliance marker of WG intake ) were measured at baseline and at 6 and 12 wk .
METHODS	A subgroup ( n = 28 ) underwent magnetic resonance imaging to quantify subcutaneous and visceral adipose tissue ( AT ) .
RESULTS	Baseline variables were not significantly different between groups ; however , the RG group tended to have higher triglycerides and lower high-density lipoprotein ( HDL ) cholesterol ( P = 0.06 ) .
RESULTS	Alkylresorcinols increased with consumption of the WG diet and did not change with consumption of the RG diet ( time treatment , P < 0.0001 ) , which showed dietary compliance .
RESULTS	There were no differences in anthropometric changes between groups ; however , weight , body mass index , and percentage of body AT decreased at both 6 and 12 wk ( P < 0.05 ) , and reductions in percentage of abdominal AT occurred by 6 wk and did not change between 6 and 12 wk ( P = 0.09 ) .
RESULTS	Both glucose ( P = 0.02 ) and HDL cholesterol ( P = 0.04 ) were lower with the consumption of the WG compared with the RG diet .
RESULTS	However , when noncompliant individuals ( n = 3 ) were removed , the glucose effect was stronger ( P = 0.01 ) and the HDL-cholesterol effect was no longer significant ( P = 0.14 ) .
CONCLUSIONS	Replacing RGs with WGs within a weight-loss diet does not beneficially affect abdominal AT loss and has modest effects on markers of MetS .
CONCLUSIONS	WGs appear to be effective at normalizing blood glucose concentrations , especially in those individuals with prediabetes .

###24731599
BACKGROUND	Intensive poultry production systems depend on chemoprophylaxis with anticoccidial drugs to combat infection .
BACKGROUND	A floor-pen study was conducted to evaluate the anticoccidial effect of Artemisia annua and Foeniculum vulgare on Eimeria tenella infection .
BACKGROUND	Five experimental groups were established : negative control ( untreated , unchallenged ) ; positive control ( untreated , challenged ) ; a group medicated with 125 ppm lasalocid and challenged ; a group medicated with A. annua leaf powder at 1.5 % in feed and challenged ; and a group treated with the mixed oils of A. annua and Foeniculum vulgare in equal parts , 7.5 % in water and challenged .
BACKGROUND	The effects of A. annua and oil extract of A. annua + F. vulgare on E. tenella infection were assessed by clinical signs , mortality , fecal oocyst output , faeces , lesion score , weight gain , and feed conversion .
RESULTS	Clinical signs were noticed only in three chickens from the lasalocid group , six from the A. annua group , and nine from the A. annua + F. vulgare group , but were present in 19 infected chickens from the positive control group .
RESULTS	Bloody diarrhea was registered in only two chickens from A. annua group , but in 17 chickens from the positive control group .
RESULTS	Mortality also occurred in the positive control group ( 7/20 ) .
RESULTS	Chickens treated with A. annua had a significant reduction in faecal oocysts ( 95.6 % ; P = 0.027 ) and in lesion score ( 56.3 % ; P = 0.005 ) when compared to the positive control .
RESULTS	At the end of experiment , chickens treated with A. annua leaf powder had the highest body weight gain ( 68.2 g/day ) , after the negative control group , and the best feed conversion ( 1.85 ) among all experimental groups .
CONCLUSIONS	Our results suggest that A. annua leaf powder ( Aa-p ) , at 1.5 % of the daily diet post-infection , can be a valuable alternative for synthetic coccidiostats , such as lasalocid .

###24460655
OBJECTIVE	Patients with non-transfusion-dependent thalassemia ( NTDT ) often develop iron overload and related complications , and may require iron chelation .
OBJECTIVE	However , the risk of over-chelation emerges as patients reach low , near-normal body iron levels and dose adjustments may be needed .
OBJECTIVE	In the THALASSA study , the threshold for chelation interruption was LIC < 3mg Fe/g dw ( LIC < 3 ) ; 24 patients receiving deferasirox for up to 2yr reached this target .
OBJECTIVE	A post hoc analysis was performed to characterize the safety profile of deferasirox as these patients approached LIC < 3 .
METHODS	THALASSA was a randomized , double-blind , placebo-controlled study of two deferasirox regimens ( 5 and 10mg/kg/d ) versus placebo in patients with NTDT .
METHODS	Patients randomized to deferasirox or placebo in the core could enter a 1-yr extension , with all patients receiving deferasirox ( extension starting doses based on LIC at end-of-core and prior chelation response ) .
METHODS	The deferasirox safety profile was assessed between baseline and 6months before reaching LIC < 3 ( Period 1 ) , and the 6months immediately before achieving LIC < 3 ( Period 2 ) .
RESULTS	Mean SD deferasirox treatment duration up to reaching LIC < 3 was 476207d , and deferasirox dose was 9.73.0 mg/kg/d .
RESULTS	The exposure-adjusted AE incidence regardless of causality was similar in periods 1 ( 1.026 ) and 2 ( 1.012 ) .
RESULTS	There were no clinically relevant differences in renal and hepatic laboratory parameters measured close to the time of LIC < 3 compared with measurements near the previous LIC assessment .
CONCLUSIONS	The deferasirox safety profile remained consistent as patients approached the chelation interruption target , indicating that , with appropriate monitoring and dose adjustments in relation to iron load , low iron burdens may be reached with deferasirox with minimal risk of over-chelation .

###25424573
BACKGROUND	Epidemiologic evidence suggests a link between short sleep duration and cardiovascular risk , although the nature of any relationship and mechanisms remain unclear .
BACKGROUND	Short sleep duration has also been linked to an increase in cardiovascular events .
BACKGROUND	Endothelial dysfunction has itself been implicated as a mediator of heightened cardiovascular risk .
BACKGROUND	We sought to determine the effect of 8 days/8 nights of partial sleep restriction on endothelial function in healthy humans .
RESULTS	Sixteen healthy volunteers underwent a randomized study of usual sleep versus sleep restriction of two-thirds normal sleep time for 8 days/8 nights in a hospital-based clinical research unit .
RESULTS	The main outcome was endothelial function measured by flow-mediated brachial artery vasodilatation ( FMD ) .
RESULTS	Those randomized to sleep restriction slept 5.1 hours/night during the experimental period compared with 6.9 hours/night in the control group .
RESULTS	Sleep restriction was associated with significant impairment in FMD ( 8.64.6 % during the initial pre-randomization acclimation phase versus 5.23.4 % during the randomized experimental phase , P = 0.01 ) whereas no change was seen in the control group ( 5.03.0 during the acclimation phase versus 6.732.9 % during the experimental phase , P = 0.10 ) for a between-groups difference of -4.40 % ( 95 % CI -7.00 to -1.81 % , P = 0.003 ) .
RESULTS	No change was seen in non-flow mediated vasodilatation ( NFMD ) in either group .
CONCLUSIONS	In healthy individuals , moderate sleep restriction causes endothelial dysfunction .
BACKGROUND	ClinicalTrials.gov .
BACKGROUND	Unique identifier : NCT01334788 .

###24373674
OBJECTIVE	To evaluate a single-use fiberscope , the Ascope-Trainer , for the training in the intubation under fiberscope .
METHODS	Prospective randomized study approved by the local ethic committee .
METHODS	After evaluation of their level of expertise , `` experienced '' or `` novices '' in intubation under fiberscope , the doctors attending the Training for Referents in Difficult Airway Management performed a test on labyrinth with a standard fiberscope ( T1 ) .
METHODS	After they were assigned to two groups , training with the Ascope-Trainer ( group A , n = 35 ) or with a classic fiberscope ( group C , n = 29 ) , they trained during 15 minutes and performed a new test ( T2 ) .
METHODS	An analysis of variance was used to compare means .
METHODS	A goal for the training was determined according to the `` experienced '' doctors ' mean T1 .
METHODS	A test of Khi ( 2 ) was used for the comparison of the number of participants having reached this goal as well as the progress in both groups A and C.
RESULTS	The T1 in the `` experienced '' group was 76 31 s and the training improved significantly T2 ( 53 17 s ) .
RESULTS	Considering the novices , T2 was significantly lower than T1 in the group A ( 77 38 s versus 135 68 s ) as well as in C ( 64 28 s versus 122 60 s ) , and the proportion of the novices having reached the goal of training was comparable in both groups .
CONCLUSIONS	Because its use is similar to the standard fiberscope , the Ascope-Trainer may be interesting for this type of training .

###24709430
OBJECTIVE	The purpose of this study was to assess the efficacy of supervised tooth-brushing with xylitol toothpaste to prevent early childhood caries ( ECC ) and reduce mutans streptococci .
METHODS	In this cluster-randomized efficacy trial , 196 four - to five-year-old children in four Head Start classrooms in the Marshall Islands were randomly assigned to supervised toothbrushing with 1,400 ppm/31 percent fluoride xylitol or 1,450 ppm fluoride sorbitol toothpaste .
METHODS	We hypothesized that there would be no difference in efficacy between the two types of toothpaste .
METHODS	The primary outcome was the surface-level primary molar caries increment ( d ( 2-3 ) mfs ) after six months .
METHODS	A single examiner was blinded to classroom assignments .
METHODS	Two classrooms were assigned to the fluoride-xylitol group ( 85 children ) , and two classrooms were assigned to the fluoride-sorbitol group ( 83 children ) .
METHODS	The child-level analyses accounted for clustering .
RESULTS	There was no difference between the two groups in baseline or end-of-trial mean d ( 2-3 ) mfs .
RESULTS	The mean d ( 2-3 ) mfs increment was greater in the fluoride-xylitol group compared to the fluoride-sorbitol group ( 2.5 and 1.4 d ( 2-3 ) mfs , respectively ) , but the difference was not significant ( 95 % confidence interval : -0.17 , 2.37 ; P = .07 ) .
RESULTS	No adverse effects were reported .
CONCLUSIONS	After six months , brushing with a low-strength xylitol/fluoride tooth-paste is no more efficacious in reducing ECC than a fluoride-only toothpaste in a high caries-risk child population .

###25677598
OBJECTIVE	Intraventricular hemorrhage ( IVH ) with spontaneous intracerebral hemorrhage indicates a poor prognosis but uncertainty exists over the pattern of association .
OBJECTIVE	We aimed to elucidate risk associations of IVH and outcome in the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial ( INTERACT2 ) data set .
METHODS	INTERACT2 was an international prospective , open-blinded end point , randomized controlled trial in 2839 patients with intracerebral hemorrhage ( < 6 hours ) with elevated systolic blood pressure randomly assigned to intensive ( target systolic blood pressure < 140 mm Hg ) or guideline-based ( systolic blood pressure < 180 mm Hg ) blood pressure management .
METHODS	Associations of baseline IVH in 740 of 2613 ( 28 % ) patients and poor outcomes ( death and major disability defined on the modified Rankin Scale ) at 90 days were determined in linear and logistic regression models .
RESULTS	Patients with IVH were significantly older and with greater neurological impairment , history of ischemic stroke , and larger hematomas more often deep hemisphere located at presentation , after adjustment for other baseline variables .
RESULTS	Death or major disability occurred in 66 % with IVH versus 49 % in intracerebral hemorrhage-alone patients ( adjusted odds ratio , 1.68 ; 95 % confidence interval , 1.38-2 .06 ; P < 0.01 ) .
RESULTS	Associations of IVH volume and clinical outcomes were strong and near continuous .
RESULTS	Adjusted analyses by thirds of IVH volume indicate thresholds of 5 and 10 mL for significantly increased odds of death and death or major disability , respectively .
CONCLUSIONS	A strong association exists between the amount of IVH and poor outcome in intracerebral hemorrhage .
CONCLUSIONS	An IVH volume of 5 to 10 mL emerges as a significant threshold for decision making on prognosis in these patients .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00716079 .

###25414081
OBJECTIVE	To identify risk factors and morbidity associated with suboptimal instrument placement at instrumental delivery .
METHODS	Observational study , nested within a randomised controlled trial .
METHODS	Two university-affiliated maternity hospitals .
METHODS	A cohort of 478 nulliparous women at term ( 37 weeks of gestation ) undergoing instrumental delivery .
METHODS	Univariable and multivariable logistic regression analyses were performed .
METHODS	Risk factors for suboptimal application of vacuum or forceps , maternal and neonatal morbidity , and the sequential use of instruments , second operator , and caesarean section following failed instrumental delivery .
RESULTS	Instrument placement was suboptimal in 138 of 478 ( 28.8 % ) deliveries .
RESULTS	Factors associated with suboptimal instrument placement included fetal malposition ( OR 2.44 , 95 % CI 1.62-3 .66 ) , mid-cavity station ( OR 1.68 , 95 % CI 1.02-2 .78 ) , and forceps as the primary instrument ( OR 2.01 , 95 % CI 1.33-3 .04 ) .
RESULTS	Compared with optimal instrument placement , suboptimal placement was associated with prolonged hospital stay ( adjusted OR 2.28 , 95 % CI 1.30-4 .02 ) and neonatal trauma ( adjusted OR 4.25 , 95 % CI 1.85-9 .72 ) .
RESULTS	Suboptimal placement was associated with a greater use of sequential instruments ( adjusted OR 3.99 , 95 % CI 1.94-8 .23 ) and caesarean section for failed instrumental delivery ( adjusted OR 3.81 , 95 % CI 1.10-13 .16 ) .
RESULTS	The mean decision to delivery interval ( DDI ) was 4 minutes longer in the suboptimal group ( 95 % CI 2.1-5 .9 minutes ) .
CONCLUSIONS	Suboptimal instrument placement is associated with increased maternal and neonatal morbidity and procedural complications .
CONCLUSIONS	Greater attention should be focused on instrument placement when training obstetricians for instrumental delivery .

###25428213
OBJECTIVE	To examine the representativeness of participants attending a lifestyle intervention study addressing obese pregnant women .
METHODS	Retrospective comparison of baseline data , attendance to oral glucose tolerance test ( OGTT ) during pregnancy , and pregnancy outcome in eligible women stratified according to study participation .
METHODS	Of 750 eligible women with a self-reported BMI > 30 kg/m ( 2 ) , and a live singleton pregnancy , 510 were eligible for inclusion and 425 were randomized to either active intervention ( n = 284 ) or to standard obstetric care ( n = 141 ) including two standard OGTT .
METHODS	The 85 women who declined participation or were excluded due to competing diseases and 240 women who did not respond to the initial invitation received the same standard care .
RESULTS	The randomized women had similar BMI but a lower parity and age , and were more frequently non-smokers , born in Denmark and married or cohabitating with their partner than the non-participants .
RESULTS	Women participating in the trial had a higher compliance to the second OGTT compared to non-participants , also after correcting for age and nationality .
RESULTS	There was no difference in pregnancy outcome , i.e. , fetal weight and length , gestational age as well as mode of delivery .
CONCLUSIONS	Women declining participation in a randomized lifestyle intervention study in pregnancy have characteristics indicating they are those who might benefit the most from lifestyle intervention .

###24885645
BACKGROUND	Gait deficits are very common after stroke and improved therapeutic interventions are needed .
BACKGROUND	The objective of this study was therefore to investigate the therapeutic use of the nociceptive withdrawal reflex to support gait training in the subacute post-stroke phase .
METHODS	Individuals were randomly allocated to a treatment group that received physiotherapy-based gait training supported by withdrawal reflex stimulation and a control group that received physiotherapy-based gait training alone .
METHODS	Electrical stimuli delivered to the arch of the foot elicited the withdrawal reflex at heel-off with the purpose of facilitating the initiation and execution of the swing phase .
METHODS	Gait was assessed before and immediately after finishing treatment , and one month and six months after finishing treatment .
METHODS	Assessments included the Functional Ambulation Category ( FAC ) test , the preferred and maximum gait velocities , the duration of the stance phase in the hemiparetic side , the duration of the gait cycle , and the stance time symmetry ratio .
RESULTS	The treatment group showed an improved post treatment preferred walking velocity ( p < 0.001 ) and fast walking velocity ( p < 0.001 ) compared to the control group .
RESULTS	Furthermore , subjects in the treatment group with severe walking impairment at inclusion time showed the best improvement as assessed by a longer duration of the stance phase in the hemiparetic side ( p < 0.002 ) and a shorter duration of the gait cycle ( p < 0.002 ) .
RESULTS	The stance time symmetry ratio was significantly better for the treatment than the control group after finishing training ( p < 0.02 ) .
RESULTS	No differences between groups were detected with the FAC test after finishing training ( p = 0.09 ) .
CONCLUSIONS	Withdrawal reflex-based functional electrical therapy was useful in the rehabilitation of the hemiparetic gait of severely impaired patients .

###25677353
OBJECTIVE	The authors evaluated the effectiveness of brief cognitive-behavioral therapy ( CBT ) for the prevention of suicide attempts in military personnel .
METHODS	In a randomized controlled trial , active-duty Army soldiers at Fort Carson , Colo. , who either attempted suicide or experienced suicidal ideation with intent , were randomly assigned to treatment as usual ( N = 76 ) or treatment as usual plus brief CBT ( N = 76 ) .
METHODS	Assessment of incidence of suicide attempts during the follow-up period was conducted with the Suicide Attempt Self-Injury Interview .
METHODS	Inclusion criteria were the presence of suicidal ideation with intent to die during the past week and/or a suicide attempt within the past month .
METHODS	Soldiers were excluded if they had a medical or psychiatric condition that would prevent informed consent or participation in outpatient treatment , such as active psychosis or mania .
METHODS	To determine treatment efficacy with regard to incidence and time to suicide attempt , survival curve analyses were conducted .
METHODS	Differences in psychiatric symptoms were evaluated using longitudinal random-effects models .
RESULTS	From baseline to the 24-month follow-up assessment , eight participants in brief CBT ( 13.8 % ) and 18 participants in treatment as usual ( 40.2 % ) made at least one suicide attempt ( hazard ratio = 0.38 , 95 % CI = 0.16-0 .87 , number needed to treat = 3.88 ) , suggesting that soldiers in brief CBT were approximately 60 % less likely to make a suicide attempt during follow-up than soldiers in treatment as usual .
RESULTS	There were no between-group differences in severity of psychiatric symptoms .
CONCLUSIONS	Brief CBT was effective in preventing follow-up suicide attempts among active-duty military service members with current suicidal ideation and/or a recent suicide attempt .

###25797640
BACKGROUND	Acupuncture anesthesia was created in the 1950 's in China and continues to be used there today during most major surgeries .
BACKGROUND	It is widely used in China for such complex operations as brain , heart , and abdominal surgery .
BACKGROUND	It is popular in China because it is economical , practical , and beneficial to the patients .
BACKGROUND	With acupuncture anesthesia there is less bleeding during surgery and there is also quicker post-operative recovery .
OBJECTIVE	This randomized prospective study aims at comparing the effect of two acupoints ( Yongquan , KI1 and Renzhong , DU26 ) with sham acupuncture and no acupuncture on the time to recovery of consciousness after general anesthesia by means of the Bispectral Index monitor ( BIS ) .
METHODS	This is a prospective randomized controlled study .
METHODS	We randomly assigned 50 patients to 5 groups during recovery from surgical anesthesia .
METHODS	Four groups had acupuncture on KI1 ( group A ) , DU26 ( groups B ) , both KI1 and DU26 ( group C ) , and sham points ( group D ) , and one had no acupuncture ( group E ) .
METHODS	Bispectral Index ( BIS ) , time to spontaneous eye opening , time to tracheal extubation , and time to following commands were measured as the main outcome measures .
RESULTS	Time to spontaneous eye opening differed among groups ( P = 0.002 ) , as well as time to tracheal extubation ( P < 0.000 1 ) and time to following commands ( P = 0.000 6 ) .
RESULTS	BIS values differed significantly among groups both 5 and 10 min after the end of anesthesia ( P < 0.000 1 and P = 0.000 4 , respectively ) .
RESULTS	BIS values of groups D and E were lower than those of the other groups and those of group C were higher .
RESULTS	The same pattern was observed also 15 and 30 min after the end of anesthesia , although the difference among groups was not significant at these time points ( P = 0.164 and P = 0.104 , respectively ) .
CONCLUSIONS	Acupuncture on DU26 and KI1 accelerates recovery of consciousness after general anesthesia .
CONCLUSIONS	Moreover , a possible synergistic effect of DU26 and KI1 is suggested .
CONCLUSIONS	This issue may play a role in the optimization of operating room management and raise interest about the usefulness of acupuncture on unconsciousness states of different nature .

###25440004
BACKGROUND	Early respiratory support and airway ( AW ) control with endotracheal intubation ( ETI ) are crucial in mass toxicology events and must be performed while wearing chemical personal protective equipment ( C-PPE ) .
OBJECTIVE	The aim of this study is to evaluate the efficiency of AW control by using second-generation supraglottic AW devices ( SADs ) as compared with ETI and first-generation SAD while wearing C-PPE .
METHODS	This is a randomized crossover trial involving 117 medical practitioners .
METHODS	Four AW management devices were examined : endotracheal tube , the first-generation SAD , laryngeal mask AW unique and 2 second-generation SAD , the laryngeal tube suction disposable , and supreme laryngeal mask AW ( SLMA ) .
METHODS	Primary end point measured were success or failure , number of attempts , and time needed to achieve successful device insertion .
METHODS	Secondary end point was a subjective appraisal of the AW devices by study population .
RESULTS	More attempts were required to achieve AW control with endotracheal tube , with and without C-PPE ( P < .001 ) .
RESULTS	Time to achieve AW control with ETI was , on average , 88 % longer than required with other devices and improved with practice .
RESULTS	The mean times to achieve an AW were longer when operators were equipped with C-PPE as compared with standard clothing .
RESULTS	Subjectively , difficulty levels were significantly higher for ETI than for all other devices ( P < .0001 ) .
CONCLUSIONS	When compared with ETI , the use of SADs significantly shortened the time for AW control while wearing C-PPE .
CONCLUSIONS	Second-generation SAD were superior to laryngeal mask AW unique .
CONCLUSIONS	These finding suggest that SADs may be used in a mass toxicology event as a bridge , until definite AW control is achieved .

###24995559
METHODS	Dietary fat influences systemic inflammatory status , which determines the progression of age-associated diseases .
METHODS	Since somatostatin ( SST ) , cortistatin ( CORT ) , and ghrelin systems modulate inflammatory response , we aim to comprehensively characterize the presence and regulation of the components of these systems in the peripheral blood mononuclear cells ( PMBCs ) , a subset of white blood cells placed at the crossroad between diet and inflammation , in response to diets with different fat composition , and during the postprandial phase in elderly subjects .
RESULTS	The applied nutrigenomic , inflammation-related PBMC-based approach revealed that the majority of components of SST/CORT and ghrelin systems are present in the human PBMCs .
RESULTS	Particularly , CORT , SST/CORT receptors ( sst2 , sst3 , sst5 , and sst5TMD4 ) , ghrelin , its acylating enzyme ( GOAT ) , In1-ghrelin variant , and GHSR1b were detected in PBMCs .
RESULTS	Their expression was altered in the long-term by diet composition , and in the short-term , during the postprandial phase .
RESULTS	Of particular relevance is the postprandial elevation of CORT , sst2 , and sst5 expression in PBMCs of subjects under n-3 PUFAs-enriched diet .
CONCLUSIONS	Our results suggest a potential relevant role of CORT/ssts and ghrelin systems in regulating PBMCs response to nutrient intake , which could help to explain the positive effects of n-3 PUFAs-enriched diets in reducing the inflammatory response .

###24746755
BACKGROUND	Delayed cord clamping allows for the passage of blood from the placenta to the baby and reduces the risk of iron deficiency in infancy .
BACKGROUND	To hold the infant for more than 1 min at the level of the vagina ( as is presently recommended ) , on the assumption that gravity affects the volume of placental transfusion , is cumbersome , might result in low compliance , and interferes with immediate contact of the infant with the mother .
BACKGROUND	We aimed to assess whether gravity affects the volume of placental transfusion
METHODS	We did a multicentre non-inferiority trial at three university-affiliated hospitals in Argentina .
METHODS	We obtained informed consent from healthy mothers with normal term pregnancies admitted early in labour .
METHODS	Vigorous babies born vaginally were randomly assigned in a 1:1 ratio by computer-generated blocks and sequentially numbered sealed opaque envelopes to be held for 2 min before clamping the umbilical cord , at the level of the vagina ( introitus group ) or on the mother 's abdomen or chest ( abdomen group ) .
METHODS	Newborn babies were weighed immediately after birth and after cord clamping .
METHODS	The primary outcome was the difference in weight ( as a proxy of placental transfusion volume ) .
METHODS	The prespecified non-inferiority margin was 18 g ( 20 % ) .
METHODS	We used t test and ( 2 ) test for group comparison , and used a multivariable linear regression analysis to control for covariables .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01497353 .
RESULTS	Between Aug 1 , 2011 , and Aug 31 , 2012 , we allocated 274 newborn babies to the introitus group and 272 to the abdomen group .
RESULTS	77 newborn babies in the introitus group and 78 in the abdomen group were ineligible after randomisation ( eg , caesarean section , forceps delivery , short umbilical cord or nuchal cord ) .
RESULTS	Mean weight change was 56 g ( SD 47 , 95 % CI 50-63 ) for 197 babies in the introitus group compared with 53 g ( 45 , 46-59 ) for 194 babies in the abdomen group , supporting non-inferiority of the two approaches ( difference 3 g , 95 % CI -5.8 to 12.8 ; p = 0.45 ) .
RESULTS	We did not note any serious adverse events during the study .
CONCLUSIONS	Position of the newborn baby before cord clamping does not seem to affect volume of placental transfusion .
CONCLUSIONS	Mothers could safely be allowed to hold their baby on their abdomen or chest .
CONCLUSIONS	This change in practice might increase obstetric compliance with the procedure , enhance maternal-infant bonding , and decrease iron deficiency in infancy .
BACKGROUND	Foundation for Maternal and Child Health ( FUNDASAMIN ) .

###25823136
OBJECTIVE	To investigate the clinical effect and safety of chiropractic in treating cervicogenic sudden hearing loss .
METHODS	From January 2011 to October 2013 , 90 patients with cervicogenic sudden hearing loss were randomly divided into treatment group and control group according to the random number table produced by SPSS 19.0 software .
METHODS	In the treatment group , there were 17 males and 28 females , aged from 31 to 62 years old with an average of ( 47.579.43 ) years ; course of disease was from 1 to 3 days with an average of ( 1.430.68 ) days ; pure-tone audiometry score was from 46.5 to 77.8 dB with the mean of ( 61.209.83 ) dB ; Northwick Park Neck Pain Questionnaire ( NPQ ) score was from 17 to 31 scores with an average of ( 23.467.18 ) scores .
METHODS	In the control group , there were 15 males and 30 females , aged from 28 to 64 years old with an average of ( 45.776.99 ) years ; course of disease was from 1 to 3 days with an average of ( 1.500.73 ) days ; pure-tone audiometry score was from 48.1 to 75.0 dB with the mean of ( 63.918.05 ) dB ; Northwick Park Neck Pain Questionnaire ( NPQ ) score was from 20 to 29 scores with an average of ( 25.6110.43 ) scores .
METHODS	The patients of control group were treated with dexamethasone intravenous drip of 10 mg , 3 days later , decreased to 5 mg , 3 days again .
METHODS	And with the methycobal intravenous drip of 500 g , treatment continued for 10 days .
METHODS	The patients of treatment group were treated with chiropractic additionally except for the therapeutic methods of control group .
METHODS	Chiropractic included local muscle loosening , attacking point , bilateral pulling atlanto-axial joint , and continuous treatment for 10 days .
METHODS	The pure-tone audiometry score and NPQ score were compared between two groups after treatment .
RESULTS	After the treatment , pure-tone audiometry score and NPQ score in treatment group improved to ( 40.23 8.14 ) dB and ( 12.708.29 ) scores respectively , which were obviously better than that of control group 's ( 37.7010.61 ) dB and ( 21.2411.13 ) scores ( P < 0.05 ) .
CONCLUSIONS	Compared with routine method for cervicogenic sudden hearing loss , additional chiropractic can improve hearing and relieve neck pain effectively .

###24588623
BACKGROUND	The right ventricular mid-septum and inflow tract are alternative pacing sites that are potentially less harmful to cardiac function .
OBJECTIVE	This study aimed to analyze the influence of these two alternative pacing sites on the clinical course of patients with chronic Chagas disease , who underwent definitive pacemaker implantation .
METHODS	A total of 80 patients with Chagas disease and classical indications for definitive pacemaker implantation were randomized into two groups between October 2008 and August 2010 : 40 received inflow tract implantation and 40 patients received mid-septum implantation .
METHODS	The analyzed parameters included : ( 1 ) progression stage of chronic chagasic cardiomyopathy ( CCC ) , ( 2 ) electrocardiographic analysis , ( 3 ) left ventricular remodeling , and ( 4 ) electromechanical dyssynchrony .
METHODS	The assessment was performed 24-48 hours after implantation and a follow-up period of 18 months .
RESULTS	Compared with inflow tract implantation , mid-septum implantation was associated with slower CCC progression and the generation of narrower QRS complexes ( 131.8 8.4 milliseconds vs 150.5 10.5 milliseconds ; P < 0.01 ) .
RESULTS	No left ventricular remodeling was detected .
RESULTS	Intraventricular dyssynchrony was more frequent in the inflow tract group than in the mid-septum group ( 85 % vs 32.5 % , respectively ; odds ratio [ OR ] , 9.15 ; P = 0.02 ) as was interventricular dyssynchrony ( 37.5 % vs 17.5 % , respectively ; OR , 2.83 ; P < 0.01 ) .
CONCLUSIONS	Mid-septum implantation was associated with slower CCC progression , generation of narrower QRS complexes , and lower electromechanical dyssynchrony , suggesting that this pacing site could be less harmful to cardiac function than the inflow tract site in patients with CCC .

###25098218
BACKGROUND	Obesity is associated with low-intensity chronic systemic inflammation .
OBJECTIVE	To evaluate the efficacy of two different doses of metformin in comparison with placebo on increased serum levels of high molecular weight ( HMW ) adiponectin .
METHODS	An experimental design was developed with a crossover complete treatment and balanced design ; 28 female and eight male nondiabetic obese adults participated .
METHODS	All participants received , during a week and in randomized order : placebo or metformin 500 or 850 mg twice daily ; there was a week washout period between each treatment .
METHODS	The HMW adiponectin serum concentration ( 0 and 120 minutes ) at the end of each treatment was measured .
METHODS	Analyses of variance ( ANOVA ) , Bonferroni test , and size effect calculations were performed .
RESULTS	Differences in concentrations of HMW adiponectin ( t0 ' , t120 ' ) were measured for each treatment by ANOVA , having values of p = 0.03 and 0.002 , respectively .
RESULTS	The post hoc analysis reported differences favoring treatment with metformin 850 mg ( p = 0.025 ) .
RESULTS	The sizes of the effect at times t0 and t120 for metformin 500 mg were 34 and 35 % , and for metformin 850 mg , 65 and 84 % , respectively .

###25539582
BACKGROUND	The Dutch Obesity Intervention in Teenagers ( DOiT ) programme is an evidence-based obesity prevention programme tailored to adolescents attending the first two years of prevocational education in the Netherlands .
BACKGROUND	The initial programme showed promising results during an effectiveness trial .
BACKGROUND	The programme was adapted and prepared for nationwide dissemination .
BACKGROUND	To gain more insight into the process of translating evidence-based approaches into ` real world ' ( i.e. , ` natural ' ) conditions , our research aims were to evaluate the impact of the DOiT-implementation programme on adolescents ' adiposity and energy balance-related behaviours during natural dissemination and to explore the mediating and moderating factors underlying the DOiT intervention effects .
METHODS	We conducted a cluster-controlled implementation trial with 20 voluntary intervention schools ( n = 1002 adolescents ) and 9 comparable control schools ( n = 484 adolescents ) .
METHODS	We measured adolescents ' body height and weight , skinfold thicknesses , and waist circumference .
METHODS	We assessed adolescents ' dietary and physical activity behaviours by means of self-report .
METHODS	Data were collected at baseline and at 20-months follow-up .
METHODS	We used multivariable multilevel linear or logistic regression analyses to evaluate the intervention effects and to test the hypothesised behavioural mediating factors .
METHODS	We checked for potential effect modification by gender , ethnicity and education level .
RESULTS	We found no significant intervention effects on any of the adiposity measures or behavioural outcomes .
RESULTS	Furthermore , we found no mediating effects by any of the hypothesised behavioural mediators .
RESULTS	Stratified analyses for gender showed that the intervention was effective in reducing sugar-containing beverage consumption in girls ( B = -188.2 ml/day ; 95 % CI = -344.0 ; -32.3 ) .
RESULTS	In boys , we found a significant positive intervention effect on breakfast frequency ( B = 0.29 days/week ; 95 % CI = 0.01 ; 0.58 ) .
RESULTS	Stratified analyses for education level showed an adverse intervention effect ( B = 0.09 ; 95 % CI = 0.02 ; 0.16 ) on BMI z-scores for adolescents attending the vocational education track .
CONCLUSIONS	Although not successful in changing adolescents ' adiposity , the DOiT-implementation programme had some beneficial effects on specific obesity-related behaviours in subgroups .
CONCLUSIONS	This study underlines the difficulty of translating intervention effectiveness in controlled settings to real world contexts .
CONCLUSIONS	Adaptations to the implementation strategy are needed in order to promote implementation as intended by the teachers .
BACKGROUND	Current Controlled Trials ISRCTN92755979 .

###25657364
OBJECTIVE	To assess the effect of using simulation in pharmacy student training on correct device technique .
METHODS	A single-blinded , repeated measures , parallel group design study was conducted in 2011 , involving all final-year pharmacy students in year 5 ( final year ) enrolled in the Clinical Pharmacy and Therapeutics course .
METHODS	Students were assessed on device technique at baseline based on previously published checklists for Diskus ( DIS ) , Turbuhaler ( TH ) , and pressurized Metered Dose Inhaler ( pMDI ) .
METHODS	Students were randomly assigned to 2 groups : Intervention A , which included supervised hands-on education in groups and peer assessment/education ; and Intervention B , which included supervised hands-on education in groups , peer assessment/education , and a simulated scenario counseling real asthma patients .
METHODS	The simulation involved groups of 6 students counseling 3 asthma patients on inhaler device technique .
METHODS	The counseling involved verbal information and physical demonstration until the patient performed all steps correctly .
METHODS	Student assessments on device technique were repeated 1 week postintervention .
RESULTS	At baseline , none of the students in Intervention A ( n = 54 ) or Intervention B ( n = 55 ) performed correct technique for any of the 3 devices .
RESULTS	One week following the intervention , a significantly higher proportion of students in Intervention B demonstrated correct technique for the Diskus , Turbuhaler , and pMDI ( 60.0 % , 70.9 % , and 69.1 % , respectively ) than did students in Intervention A ( 27.8 % , 40.7 % , and 42.6 % , respectively , p < 0.005 ) .
CONCLUSIONS	Engaging pharmacy students with real asthma patients in a simulated scenario involving correct device technique education resulted in better device technique demonstration skills among students .

###24943480
BACKGROUND	Alterations in serotonergic ( 5-HT ) metabolism and/or intestinal integrity have been associated with irritable bowel syndrome ( IBS ) .
OBJECTIVE	To assess the effects of the precursor of 5-HT , 5-hydroxytryptophan ( 5-HTP ) , on mucosal 5-HT availability and intestinal integrity , and to assess potential differences between healthy controls and IBS patients .
METHODS	Fifteen IBS patients and 15 healthy volunteers participated in this randomised double-blind placebo-controlled study .
METHODS	Intestinal integrity was assessed by dual-sugar test and by determining the mucosal expression of tight junction proteins after ingestion of an oral bolus of 100 mg 5-HTP or placebo .
METHODS	Mucosal serotonergic metabolism was assessed in duodenal biopsy samples .
RESULTS	5-HTP administration significantly increased mucosal levels of 5-HIAA , the main metabolite of 5-HT , in both healthy controls ( 7.1 1.7 vs. 2.5 0.7 pmol/mg , 5-HTP vs. placebo , P = 0.02 ) and IBS patients ( 20.0 4.8 vs. 8.1 1.3 pmol/mg , 5-HTP vs. placebo , P = 0.02 ) , with the latter group showing a significantly larger increase .
RESULTS	Lactulose/L-rhamnose ratios were significantly lower after administration of 5-HTP ( P < 0.05 ) in healthy controls and were accompanied by redistribution of zonula occludens-1 ( ZO-1 ) , pointing to reinforcement of the barrier .
RESULTS	In IBS , expression of the tight junction proteins was significantly lower compared to healthy controls , and 5-HTP resulted in a further decrease in occludin expression .
CONCLUSIONS	Oral 5-HTP induced alterations in mucosal 5-HT metabolism .
CONCLUSIONS	In healthy controls , a reinforcement of the intestinal barrier was seen whereas such reaction was absent in IBS patients .
CONCLUSIONS	This could indicate the presence of a serotonin-mediated mechanism aimed to reinforce intestinal barrier function , which seems to dysfunction in IBS patients .

###25843816
OBJECTIVE	To evaluate the effects of immediate postoperative submucosal dexamethasone administration on postoperative pain , edema , trismus , and mandibular functions after open reduction and internal fixation ( ORIF ) for mandibular fractures .
METHODS	We conducted a prospective , randomized , controlled , double-blind study of 40 patients who required ORIF for mandibular fractures under general anesthesia .
METHODS	The patients were divided into 2 groups , an experimental group ( n = 20 ) who received immediate postoperative submucosal 8mg ofdexamethasone through the surgical incision site , and a control group ( n = 20 ) who did not receive dexamethasone .
METHODS	Pain was assessed using a visual analog scale ( VAS ) score and the frequency of analgesic consumption at the various postoperative intervals .
METHODS	The maximum interincisal distance and facial measurements were compared before surgery and at 24 , 48 , and 72hours and 7days after surgery .
METHODS	The difficulty in mandibular function after surgery was graded as mild , moderate , or severe .
RESULTS	The analgesic drugs required 2hours after surgery and the VAS score 72hours after surgery were significantly less ( P < .05 ) in the experimental group than in the control group .
RESULTS	The total number of diclofenac tablets required by the experimental group was less than that for the control group , but the difference was not statistically significant .
RESULTS	The control group had significantly increased swelling ( P < .05 ) compared with the experimental group from preoperatively to 24hours postoperatively ( experimental group 0.115 0.143 , control group 0.253 0.173 ) .
RESULTS	No statistically significant difference was present in the mouth opening or difficulty in mandibular function at the different follow-up intervals between the 2 groups ( P > .05 ) .
CONCLUSIONS	The results of our study suggest that submucosal administration of dexamethasone after ORIF for mandibular fractures is effective in reducing postoperative pain and edema .

###25103026
BACKGROUND	Paired associative stimulation ( PAS ) is a widely used method to study spike timing dependent plasticity in motor cortex .
BACKGROUND	Repeated pairing of an electrical stimulus to the median nerve with transcranial magnetic stimulation ( TMS ) over the contralateral motor cortex at interstimulus intervals ( ISIs ) of 21.5-25ms leads to a long term potentiation ( LTP ) - like synaptic plasticity in the corticospinal system .
BACKGROUND	Previously we found that concurrent transcranial direct current stimulation ( TDCS ) over cerebellum blocked the effect of PAS25 but not PAS21 .5 , implying that two separate mechanisms were involved .
OBJECTIVE	We hypothesized that if PAS21 .5 and PAS25 increased corticospinal excitability by two entirely separate mechanisms then their effects might summate if we intermixed them in the same session .
METHODS	Twenty-four healthy volunteers were studied .
METHODS	Eight subjects were selected who showed the expected facilitation after both standard PAS21 .5 and PAS25 with 180 pairs .
METHODS	They participated to two sessions in which PAS consisted of 360 electrical stimuli of the right median nerve paired with a single TMS over the hotspot of right APB at randomly delivered ISIs of 25ms and of 21.5 ms ( 180 pairs for each ISI ) ( PASvar360p ) .
METHODS	Either sham or anodal TDCS ( 2mA , 30min ) was applied to the cerebellum simultaneously with PASvar360p .
METHODS	Subsequently , we applied a protocol with 90 pairs for each ISI ( PASvar180p ) .
METHODS	We measured motor evoked potentials ( MEPs ) before and after each intervention .
RESULTS	Although PAS21 .5 and PAS25 each produce corticospinal facilitation when applied alone , the after-effects disappeared if we randomly intermixed PAS21 .5 and PAS25 using either 180 pairs ( PASvar360p ) or 90 pairs ( PASvar180p ) for each ISI .
RESULTS	Facilitation is restored if anodal but not sham TDCS is applied concurrently over the cerebellum to block the effect of PAS25 .
CONCLUSIONS	PAS21 .5 and PAS25 not only engage two separate mechanisms but also they are mutually inhibitory .

###25186034
OBJECTIVE	To assess patient-reported outcomes ( PROs ) for tofacitinib , an oral JAK inhibitor for the treatment of rheumatoid arthritis ( RA ) , in a 6-month , phase III , randomized controlled trial .
METHODS	Patients ages 18 years with active RA with an inadequate response to 1 tumor necrosis factor inhibitor ( TNFi ) and receiving stable background methotrexate were randomized 2:2:1:1 to tofacitinib 5 mg or 10 mg twice daily , or placebo advanced to tofacitinib 5 mg or 10 mg twice daily at month 3 .
METHODS	PROs measured at month 3 included patient global assessment of disease activity ( PtGA ) , pain , Health Assessment Questionnaire ( HAQ ) disability index ( DI ) , Medical Outcomes Study ( MOS ) Short Form 36 Health Survey version 2 ( SF-36v2 ; acute ) , Functional Assessment of Chronic Illness Therapy-Fatigue ( FACIT-F ) , and MOS Sleep Scale .
RESULTS	Patients received tofacitinib 5 mg ( n = 133 ) or 10 mg ( n = 134 ) or placebo advanced to tofacitinib 5 mg ( n = 66 ) or 10 mg ( n = 66 ) .
RESULTS	HAQ DI ( reported previously ) , PtGA ( P < 0.0001 ) , and SF-36v2 physical and mental component summary ( P < 0.05 ) scores were improved for both tofacitinib doses versus placebo .
RESULTS	Furthermore , improvements greater than or equal to the minimum clinically important difference were more frequently reported by tofacitinib-treated patients versus placebo for PtGA ( P < 0.05 ) , pain ( P < 0.0001 ) , HAQ DI ( P < 0.05 ) , SF-36v2 physical and mental component summary scores ( P < 0.05 ) , and FACIT-F ( P < 0.001 for 5 mg twice daily ) .
RESULTS	No statistical differences were observed in the MOS Sleep Scale .
CONCLUSIONS	Tofacitinib treatment resulted in significant , clinically meaningful improvements in multiple PROs versus placebo over 3 months of treatment in patients with active RA and a previous inadequate response to TNFi .

###24247217
OBJECTIVE	Previous studies have shown that central obesity is associated with chronic kidney disease ( CKD ) .
OBJECTIVE	We hypothesized that the association of central obesity with CKD is modified by the presence of inflammation .
OBJECTIVE	To test this hypothesis , we performed this study .
METHODS	This was a cross-sectional study in southern China .
METHODS	Waist-to-height ratio ( WHtR ) was used as a central obesity index and C-reactive protein ( CRP ) was used as an index for inflammation .
METHODS	CKD was defined as estimated glomerular filtration rate ( eGFR ) < 60 ml/min/1 .73 m ( 2 ) or albuminuria-to-creatinine ratio ( ACR ) > 30mg/g .
METHODS	Multivariable logistic regressions were used and logistic regression models were adjusted for potential confounders and other components of metabolic syndrome .
RESULTS	1834 subjects were included in the current study .
RESULTS	WHtR , body mass index and waist circumference were significantly associated with the level of CRP .
RESULTS	When adjustment for potential confounders , only central obesity with a higher CRP level was associated with CKD ( Relavitve-risk Ratio , 95 % CI : 1.68 , 1.03 - 2.75 , P = 0.04 ) .
RESULTS	In multivariate logistic models , WHtR was associated with CKD .
RESULTS	The odd ratio for WHtR ( every SD increment ) , was 1.38 ( 95 % CI 1.15 , 1.66 , P < 0.001 ) .
RESULTS	Further adjustment for log-transformed CRP had an impact on the odd ratios .
CONCLUSIONS	Central obesity is associated with CKD , independently of other MetS components .
CONCLUSIONS	Central obesity is also associated with inflammation and the presence of inflammation modifies the associations of central obesity and CKD .
CONCLUSIONS	This study is based on a community-based chinese population , and the results may only be applicable for Chinese population .

###24979880
OBJECTIVE	Lumbar puncture ( LP ) is usually associated with anxiety and apprehension in children and their parents .
OBJECTIVE	This study was performed for controlling children 's anxiety before and during LP and increasing the success of LP due to relaxation of the child following the use of sedative drugs and to compare the efficacy and side effects of oral midazolam and oral chloral hydrate .
METHODS	This prospective randomized controlled clinical trial included 160 children aged 2-7 years , candidates for LP .
METHODS	They were divided into two randomized groups of 80 children each : group I received 80 mg/kg oral chloral hydrate and group II received 0.5 mg/kg oral midazolam before LP .
RESULTS	The results indicated that the mean sedation grade was 3.8 + / - 1.0 in chloral hydrate group and 2.3 + / - 0.9 in midazolam group ( P < 0.001 ) .
RESULTS	The mean onset of sedative effect was 30.9 + / - 8.8 min in midazolam group and 16.5 + / - 5.8 min in chloral hydrate group ( P < 0.001 ) .
RESULTS	Prolonged sedation was the most common side effect in oral midazolam group ( 94.4 % ) versus 22.2 % in chloral hydrate group .
CONCLUSIONS	Based on the level of sedation , side effects , time to onset of sedation and recovery time from sedation , oral chloral hydrate is a better sedative medication than oral midazolam .

###25431336
OBJECTIVE	Previous heart failure ( HF ) trials suggested that age influences patient characteristics and outcome ; however , under-representation of elderly patients has limited characterization of this cohort .
OBJECTIVE	Whether standard prognostic variables have differential utility in various age groups is unclear .
RESULTS	The PROTECT trial investigated 2033 patients ( median age 72 years ) with acute HF randomized to rolofylline or placebo .
RESULTS	Patients were divided into five groups based on the quintiles of age : 59 , 60-68 , 69-74 , 75-79 , and 80years .
RESULTS	Baseline characteristics , medications , and outcomes ( 30-day death or cardiovascular/renal hospitalization , and death at 30 and 180 days ) were explored .
RESULTS	The prognostic utility of baseline characteristics for outcomes was investigated in the different groups and in those aged < 80years vs. 80years .
RESULTS	With increasing age , patients were more likely to be women with hypertension , AF , and higher EF .
RESULTS	Increased age was associated with increased risk of 30 - and 180-day outcomes , which persisted after multivariable adjustment ( hazard ratio for 180-day death = 1.17 ; 95 % confidence interval 1.11-1 .24 for each 5-year increase ) .
RESULTS	The prognostic utility of baseline characteristics such as previous HF hospitalization and serum sodium , systolic blood pressure , and NYHA class was attenuated in the elderly for the endpoint of 180-day mortality .
RESULTS	An increase in albumin was associated with a greater reduction in risk in patients aged 80years vs. < 80years .
CONCLUSIONS	In a large trial of acute HF , there were differences in baseline characteristics and outcomes amongst patients of different ages .
CONCLUSIONS	Standard prognostic variables exhibit different utility in elderly patients .

###24732894
OBJECTIVE	Restenosis following extracranial artery stenting is a limitation that affects long-term outcomes .
OBJECTIVE	Effective and satisfying pharmacological strategies in preventing restenosis have not been established .
OBJECTIVE	This study aimed to evaluate whether argatroban , a direct thrombin inhibitor , could reduce the risk of in-stent restenosis after extracranial artery stenting .
METHODS	One hundred and fourteen patients hospitalized between August 2010 and August 2011 were enrolled .
METHODS	Patients were randomly assigned to argatroban ( n = 58 ) and blank control groups ( n = 56 ) .
METHODS	The patients in the argatroban arm were treated with 10 mg of intravenous argatroban twice daily 2 days before and 3 days after the stenting procedures .
METHODS	Patients were followed for 12 months after the procedure .
METHODS	During follow-up , restenosis and target revascularization were analyzed .
METHODS	Recurrent cerebrovascular and cardiovascular events and deaths were also compared between the groups .
RESULTS	One patient in the stenting group withdrew immediately after the procedure due to unsuccessful stenting .
RESULTS	Restenosis occurred in 4 patients ( 7.4 % ) in the argatroban group and in 11 patients ( 21.6 % ) in the control group during the 6 - to 9-month angiographic follow-up period ( p = 0.032 ) .
RESULTS	Nine months after the procedures , argatroban-treated patients had a trend towards a lower incidence of target revascularization compared with the controls ( 5.4 vs. 13.7 % , p = 0.188 ) .
RESULTS	No major bleeding events or other adverse events occurred in the argatroban group .
CONCLUSIONS	This pilot clinical trial is the first that uses argatroban to prevent restenosis in ischemic cerebrovascular disease , and suggests that intravenous administration of argatroban is effective and safe in preventing restenosis after extracranial artery stenting .
CONCLUSIONS	Larger randomized controlled clinical trials are warranted .

###24619335
BACKGROUND	Several studies have demonstrated skills transfer after virtual reality ( VR ) simulation training in laparoscopic surgery .
BACKGROUND	However , the impact of VR simulation training on transfer of skills related to laparoscopic colectomy remains not investigated .
BACKGROUND	The present study aimed at determining the impact of VR simulation warm-up on performance during laparoscopic colectomy in the porcine model .
METHODS	Fourteen residents naive to laparoscopic colectomy as surgeons were randomly assigned in block to two groups .
METHODS	Seven trainees completed a 2-h VR simulator training in the laparoscopic sigmoid colectomy module ( study group ) .
METHODS	The remaining seven surgeons ( control group ) underwent no intervention .
METHODS	On the same day , all participants performed a sigmoid colectomy with anastomosis on a pig .
METHODS	All operations were video recorded .
METHODS	Two board-certified expert colorectal surgeons independently assessed performance during the colectomy on the swine .
METHODS	Examiners were blinded to group assignment .
METHODS	The two examiners used a previously validated clinical instrument specific to laparoscopic colectomy .
METHODS	The primary outcome was the generic and specific skills score values .
RESULTS	Surgeons undergoing short-duration training on the VR simulator performed significantly better during laparoscopic colectomy on the pig regarding general and specific technical skills evaluation .
RESULTS	The average score of generic skills was 17.2 ( 16.5-18 ) for the control group and 20.1 ( 16.5-22 ) for the study group ( p = 0.002 ) .
RESULTS	The specific skills average score for the control group was 20.2 ( 19-21 .5 ) and 24.2 ( 21-27 .5 ) for the study group ( p = 0.001 ) .
RESULTS	There was acceptable concordance ( Kendall ` sW ) regarding the video assessment of generic ( W = 0.78 ) and specific skills ( W = 0.84 ) between the two examiners .
CONCLUSIONS	A single short-duration VR simulator practice positively impacted surgeons ' generic and specific skills performance required to accomplish laparoscopic colectomy in the swine model .

###25649640
OBJECTIVE	To evaluate the safety and efficacy of a new multipurpose disinfecting solution ( MPDS ) with a formulation that includes aloe vera on its composition .
METHODS	This is a prospective , randomized , double-masked clinical trial with a crossover design that included seven examinations .
METHODS	Two different MPDSs , Avizor Alvera ( study solution ) and All Clean Soft ( control solution ) , each were used for 1 month .
METHODS	Comfilcon A silicone hydrogel contact lenses were used during the trial .
METHODS	The main outcome variables were corneal staining and deposits on the surfaces of the contact lenses .
METHODS	Other parameters including ocular surface response , contact lens wettability , user satisfaction , and adverse events , were analyzed according to the International Organization for Standardization ( ISO ) 11980:2010 guidance for clinical investigation .
RESULTS	Twenty subjects ( 10 women , 10 men ) ( mean age , 27.75.6 years ; range , 20-41 ) were included .
RESULTS	No differences between both MPDSs were found in the percentage of subjects with corneal staining > 0 at day 30 ( study : 35 % , control : 50 % ; p = 0.46 ) ; neither in the percentage of subjects with deposits on the surface of the contact lens > 0 at day 30 ( study : 26.32 % , control : 52.63 % ; p = 0.18 ) .
RESULTS	The study MPDS received higher rates in comfort ( study : 8.141.09 , control : 7.940.92 ; p = 0.56 ) and satisfaction at day 30 ( study : 8.630.91 , control : 8.290.80 ; p = 0.19 ) , however the scores were not significantly different with the control MPDS .
CONCLUSIONS	The clinical trial showed that the study MPDS is safe , efficient , and has acceptable physiologic tolerance , according to the ISO 11980:2010 guidance for clinical investigation .

###24382002
BACKGROUND	Sclerostin is an osteocyte-derived inhibitor of osteoblast activity .
BACKGROUND	The monoclonal antibody romosozumab binds to sclerostin and increases bone formation .
METHODS	In a phase 2 , multicenter , international , randomized , placebo-controlled , parallel-group , eight-group study , we evaluated the efficacy and safety of romosozumab over a 12-month period in 419 postmenopausal women , 55 to 85 years of age , who had low bone mineral density ( a T score of -2.0 or less at the lumbar spine , total hip , or femoral neck and -3.5 or more at each of the three sites ) .
METHODS	Participants were randomly assigned to receive subcutaneous romosozumab monthly ( at a dose of 70 mg , 140 mg , or 210 mg ) or every 3 months ( 140 mg or 210 mg ) , subcutaneous placebo , or an open-label active comparator -- oral alendronate ( 70 mg weekly ) or subcutaneous teriparatide ( 20 g daily ) .
METHODS	The primary end point was the percentage change from baseline in bone mineral density at the lumbar spine at 12 months .
METHODS	Secondary end points included percentage changes in bone mineral density at other sites and in markers of bone turnover .
RESULTS	All dose levels of romosozumab were associated with significant increases in bone mineral density at the lumbar spine , including an increase of 11.3 % with the 210-mg monthly dose , as compared with a decrease of 0.1 % with placebo and increases of 4.1 % with alendronate and 7.1 % with teriparatide .
RESULTS	Romosozumab was also associated with large increases in bone mineral density at the total hip and femoral neck , as well as transitory increases in bone-formation markers and sustained decreases in a bone-resorption marker .
RESULTS	Except for mild , generally nonrecurring injection-site reactions with romosozumab , adverse events were similar among groups .
CONCLUSIONS	In postmenopausal women with low bone mass , romosozumab was associated with increased bone mineral density and bone formation and with decreased bone resorption .
CONCLUSIONS	( Funded by Amgen and UCB Pharma ; ClinicalTrials.gov number , NCT00896532 . )

###24886228
BACKGROUND	In the UK , chronic disease , including chronic kidney disease ( CKD ) is largely managed in primary care .
BACKGROUND	We developed a tool to assess practitioner confidence and knowledge in managing CKD compared to other chronic diseases .
BACKGROUND	This questionnaire was part of a cluster randomised quality improvement interventions in chronic kidney disease ( QICKD ; ISRCTN56023731 ) .
METHODS	The questionnaire was developed by family physicians , primary care nurses , academics and renal specialists .
METHODS	We conducted three focus groups ( n = 7 , 6 , and 8 ) to refine the questionnaire using groups of general practitioners , practice nurses and trainees in general practice .
METHODS	We used paper based versions to develop the questionnaire and online surveys to test it .
METHODS	Practitioners in a group of volunteer , trial practices received the questionnaire twice .
METHODS	We measured its reliability using Cohen 's Kappa ( K ) .
RESULTS	The practitioners in the focus groups reached a consensus as to the key elements to include in the instrument .
RESULTS	We achieved a 73.1 % ( n = 57/78 ) initial response rate for our questionnaire ; of these 57 , 54 completed the questionnaire a second time .
RESULTS	Family physicians made up the largest single group of respondents ( 47.4 % , n = 27 ) .
RESULTS	Initial response showed more female ( 64.9 % , n = 37 ) than male ( 35.1 % , n = 20 ) respondents .
RESULTS	The reliability results from retesting showed that there was moderate agreement ( k > 0.4 ) on all questions ; with many showing substantial agreement ( k > 0.6 ) .
RESULTS	There was substantial agreement in the questions about loop diuretics ( k = 0.608 , CI 0.432-0 .784 , p < 0.001 ) , confidence in managing hypertension ( k = 0.628 , 95 % CI 0.452-0 .804 , p < 0.001 ) , diastolic blood pressure treatment thresholds in CKD ( k = 0.608 , 95 % CI 0.436-0 .780 , p < 0.001 ) and the rate of decline of eGFR that would prompt referral ( k = 0.764 , 95 % CI 0.603-0 .925 , p < 0.001 ) .
CONCLUSIONS	The QICKD-CCQ is a reliable instrument for measuring confidence and knowledge among primary care practitioners on CKD management in the context of UK primary care .

###24748783
BACKGROUND	Aging-related reduced spinal mobility can interfere with the execution of important functional skills and activities in elderly women .
BACKGROUND	Although several studies have shown positive outcomes in response to spinal flexibility training programs , little is known about the management of sets and repetitions in training protocols .
BACKGROUND	The purpose of this study was to investigate the effects of an 8-week specific and standardized flexibility training program on the range of spinal motion in elderly women .
METHODS	PARTICIPANTS WERE RECRUITED IN A SENIOR CENTER OF PALERMO AND RANDOMLY ASSIGNED IN TWO GROUPS : trained group ( TG ) and control group ( CG ) , which included 19 and 18 women , respectively .
METHODS	TG was trained for 8 weeks at two sessions/week .
METHODS	In particular , every session included three phases : warm up ( ~ 10 minutes ) , central period ( ~ 50 minutes ) , and cool down ( ~ 10 minutes ) .
METHODS	CG did not perform any physical activity during the experimental period .
METHODS	Spinal ranges of motion ( ROM ) were measured from neutral standing position to maximum bending position and from neutral standing position to maximum extension position before and after the experimental period , using a SpinalMouse device ( Idiag , Volkerswill , Switzerland ) .
RESULTS	After the training period , TG showed an increase in spinal inclination by 16.4 % ( P < 0.05 ) , in sacral/hip ROM by 29.2 % ( P < 0.05 ) , and in thoracic ROM by 22.5 % ( P > 0.05 ) compared with CG from maximum extension position to maximum bending position .
RESULTS	We did not observe any significant difference in TG 's lumbar ROM compared with CG after the training period ( P > 0.05 ) .
CONCLUSIONS	We found that an 8-week flexibility training program improved ROMs of the spine in elderly women .
CONCLUSIONS	The training protocol appeared to be practicable for active elderly people with autonomy and the capability for self-care .

###25003777
OBJECTIVE	Encouraging dog walking may increase physical activity in dog owners .
OBJECTIVE	This cluster-randomized controlled trial investigated whether a social networking Web site ( Meetup ) could be used to deliver a multicomponent dog walking intervention to increase physical activity .
METHODS	Sedentary dog owners ( n = 102 ) participated .
METHODS	Eight neighborhoods were randomly assigned to the Meetup condition ( Meetup ) or a condition where participants received monthly e-mails with content from the American Heart Association regarding increasing physical activity .
METHODS	The Meetup intervention was delivered over 6 months and consisted of newsletters , dog walks , community events , and an activity monitor .
METHODS	The primary outcome was steps ; secondary outcomes included social support for walking , sense of community , perceived dog walking outcomes , barriers to dog walking , and feasibility of the intervention .
RESULTS	Mixed-model analyses examined change from baseline to postintervention ( 6 months ) and whether change in outcomes differed by condition .
RESULTS	Daily steps increased over time ( P = 0.04 , d = 0.28 ) , with no differences by condition .
RESULTS	The time-condition interaction was significant for the perceived outcomes of dog walking ( P = 0.04 , d = 0.40 ) , such that the Meetup condition reported an increase in the perceived positive outcomes of dog walking , whereas the American Heart Association condition did not .
RESULTS	Social support , sense of community , and dog walking barriers did not significantly change .
RESULTS	Meetup logins averaged 58.38 per week ( SD , 11.62 ) .
RESULTS	Within 2 months of the intervention ending , organization of the Meetup groups transitioned from the study staff to Meetup members .
CONCLUSIONS	Results suggest that a Meetup group is feasible for increasing physical activity in dog owners .
CONCLUSIONS	Further research is needed to understand how to increase participation in the Meetup group and facilitate greater connection among dog owners .

###24383478
BACKGROUND	A wireless motility capsule is a new method for ambulatory assessment of transit times and motility throughout the gastrointestinal tract .
BACKGROUND	The objective of this study was to evaluate the ability of a wireless motility capsule to detect drug effects on gastric emptying time ( GET ) and gastric contractility .
METHODS	15 healthy adults were administered in random order saline , erythromycin IV 150 mg , or morphine IV 0.05 mg/kg BW .
METHODS	Subjects ate a standard meal after each infusion , and subsequently ingested the motility capsule .
METHODS	Data were recorded for 8 hours , and the results were analyzed using the manufacturer 's software .
RESULTS	GET was significantly faster after erythromycin than either saline or morphine .
RESULTS	Morphine tended to delay emptying of the capsule compared to saline .
RESULTS	There was a trend toward a greater frequency of gastric contractions with erythromycin and a reduced frequency of gastric contractions with morphine that did not reach statistical significance .
CONCLUSIONS	A wireless motility capsule successfully detected acceleration of gastric emptying induced by erythromycin , and retardation of gastric motility caused by morphine .
CONCLUSIONS	These results indicate that a wireless motility capsule is a promising technique to assess pharmacologic effects on gastric transit and contractility and aid in development of drugs for gastric motor disorders .

###25010405
OBJECTIVE	The steep ramp test ( SRT ) can be used to provide an indication of exercise capacity when gas exchange measurements are not possible .
OBJECTIVE	This study evaluated the clinical usefulness of the SRT in adolescents with cystic fibrosis ( CF ) and compared the physiological responses of the SRT with the standard cardiopulmonary exercise test ( CPET ) .
METHODS	Forty patients with CF ( 17 boys and 23 girls ; mean SD age , 14.7 1.7 years ; forced expiratory volume in 1 s , 86 % 18 % of predicted ) performed an SRT and a CPET with respiratory gas analysis in a randomized balanced design .
METHODS	Peak work rate ( WRpeak ) , HRpeak , peak minute ventilation ( VEpeak ) , and peak oxygen uptake ( VO2peak ) were the main outcome measures .
RESULTS	Patients with CF attained values for absolute and relative WRpeak during the SRT of 82 % 14 % and 92 % 14 % of predicted .
RESULTS	Nutritional status and degree of airway obstruction did not influence SRT performance .
RESULTS	Significantly higher values were attained for WRpeak during the SRT compared with those during the CPET ( 252 60 vs 174 46 W ; P < 0.001 ) , whereas significantly lower values were achieved for HRpeak ( 168 14 vs 182 12 bpm ; P < 0.001 ) , VEpeak ( 59.2 19.5 vs 72.0 20.2 Lmin ( -1 ) ; P = 0.006 ) , and VO2peak ( 36.9 7.5 vs 41.5 7.6 mLkg ( -1 ) min ( -1 ) ; P = 0.008 ) .
RESULTS	A strong correlation between WRpeak attained at the SRT and the VO2peak achieved during the CPET was found ( r = 0.822 , P < 0.001 ) .
CONCLUSIONS	The SRT seems to be a quick , convenient , and low-cost exercise test that is well-tolerated in patients with CF with mild-to-moderate airway obstruction .
CONCLUSIONS	It provides an indication of exercise capacity and can potentially be used when exercise testing using gas exchange measurements is not possible .

###25326035
BACKGROUND	Depression is a prevalent disorder , associated with a high disease burden and substantial societal , economic and personal costs .
BACKGROUND	Cognitive behavioural treatment has been shown to provide adequate treatment for depression .
BACKGROUND	By offering this treatment in a blended format , in which online and face-to-face treatment are combined , it might be possible to reduce the number of costly face-to-face sessions required to deliver the treatment protocol .
BACKGROUND	This could improve the cost-effectiveness of treatment , while maintaining clinical effects .
BACKGROUND	This protocol describes the design of a pilot study for the evaluation of the feasibility , acceptability and cost-effectiveness of blended cognitive behavioural therapy for patients with major depressive disorder in specialized outpatient mental health care .
METHODS	In a randomized controlled trial design , adult patients with major depressive disorder are allocated to either blended cognitive behavioural treatment or traditional face-to-face cognitive behavioural treatment ( treatment as usual ) .
METHODS	We aim to recruit one hundred and fifty patients .
METHODS	Blended treatment will consist of ten face-to-face and nine online sessions provided alternately on a weekly basis .
METHODS	Traditional cognitive behavioural treatment will consist of twenty weekly sessions .
METHODS	Costs and effects are measured at baseline and after 10 , 20 and 30 weeks .
METHODS	Evaluations are directed at cost-effectiveness ( with depression severity and diagnostic status as outcomes ) , and cost-utility ( with costs per quality adjusted life year , QALY , as outcome ) .
METHODS	Costs will encompass health care uptake costs and productivity losses due to absence from work and lower levels of efficiency while at work .
METHODS	Other measures of interest are mastery , working alliance , treatment preference at baseline , depressive cognitions , treatment satisfaction and system usability .
CONCLUSIONS	The results of this pilot study will provide an initial insight into the feasibility and acceptability of blended cognitive behavioural treatment in terms of clinical and economic outcomes ( proof of concept ) in routine specialized mental health care settings , and an indication as to whether a well-powered clinical trial of blended cognitive behavioural treatment for depression in routine practice would be advisable .
CONCLUSIONS	This will be determined based on the perspective of various stakeholders including patients , mental health service providers and health insurers .
CONCLUSIONS	Strengths and limitations of the study are discussed .
BACKGROUND	Netherlands Trial Register NTR4650 .
BACKGROUND	Registered 18 June 2014 .

###25015214
OBJECTIVE	To assess vision-related quality of life in Fuchs ' dystrophy and changes in vision-related quality of life after 3 types of keratoplasty ( penetrating keratoplasty [ PK ] , deep lamellar endothelial keratoplasty [ DLEK ] , and Descemet stripping endothelial keratoplasty [ DSEK ] ) .
METHODS	Prospective , observational case series .
METHODS	Sixty-three subjects with Fuchs ' endothelial dystrophy : 12 subjects ( 12 eyes ) received PK , 11 subjects ( 11 eyes ) received DLEK , and 40 subjects ( 40 eyes ) received DSEK .
METHODS	Subjects were examined before keratoplasty and at regular intervals through 3 years after keratoplasty .
METHODS	At each examination , vision-related quality of life was assessed using the 25-item National Eye Institute Visual Functioning Questionnaire ; best spectacle-corrected and uncorrected visual acuities were measured by using the electronic Early Treatment of Diabetic Retinopathy Study protocol ; keratometric cylinder was measured by a manual keratometer .
METHODS	Disability glare was measured with a straylight meter .
METHODS	Vision-related quality of life composite score .
RESULTS	Vision-related quality of life composite score for all eyes with Fuchs ' dystrophy before keratoplasty was 72 11 ( n = 63 ) and did not differ between groups ( P = 0.88 ) .
RESULTS	Vision-related quality of life improved by 6 months ( PK , P = 0.008 ; DLEK , P = 0.03 ; DSEK , P < 0.001 ) , with continued improvement between 6 months and 3 years after PK ( P = 0.01 ) and DSEK ( P = 0.004 ) .
RESULTS	At 6 months , the composite score was higher after DSEK than after PK ( P = 0.006 ) .
RESULTS	At 3 years , there were no differences in composite scores between the 3 treatments ( P = 0.33 ; mean minimum detectable difference , 8 [ = 0.05 ; = 0.20 ] ) .
RESULTS	After keratoplasty , quality of life was correlated with uncorrected visual acuity at 1 year ( r = -0.38 ; P = 0.001 ) and at 3 years ( r = -0.36 ; P = 0.02 ) , with disability glare at 3 years ( r = -0.41 ; P = 0.02 ) , and with best-corrected visual acuity at 6 months ( r = -0.34 ; P = 0.03 ) , but not thereafter .
CONCLUSIONS	Vision-related quality of life in patients with Fuchs ' endothelial dystrophy is significantly impaired but improves after keratoplasty , irrespective of the technique .
CONCLUSIONS	The improvement is faster after DSEK than after PK , and this might be explained in part by rapid improvement in uncorrected visual acuity after DSEK .
CONCLUSIONS	This study affirms an advantage of endothelial keratoplasty over PK with respect to patient-reported outcomes .

###24678761
BACKGROUND	Recent studies suggest that excessive gestational weight gain ( GWG ) leads to adverse maternal and fetal outcomes including weight retention in the mother and an increased risk of childhood obesity in the offspring.The aim of the GeliS study is to examine the effect of a lifestyle intervention programme during pregnancy to avoid excessive GWG and , hence , to reduce pregnancy and obstetric complications as well as the risk of maternal and offspring obesity .
METHODS	The GeliS study is a multicentre cluster-randomized controlled trial .
METHODS	A total number of 2500 pregnant women ( singleton pregnancy ) with a pre-pregnancy BMI 18.5 kg/m2 and 40 kg/m2 will be recruited in practices of gynaecologists and midwives in ten Bavarian regions .
METHODS	The intervention comprises three structured and individualised counselling sessions on a healthy diet , regular physical activity as well as weight monitoring during pregnancy and one session after delivery , respectively .
METHODS	The counselling sessions are attached to routine pre - and postnatal visits using standardised materials and procedures .
METHODS	In the control regions , general recommendations for a healthy lifestyle are given .
METHODS	An oral glucose tolerance test is offered to all participants.The primary outcome is the proportion of participants with excessive GWG .
METHODS	Secondary outcomes include pregnancy and obstetric complications such as frequency of gestational diabetes , preeclampsia and caesarean sections as well as weight retention in the mothers and BMI and other health variables in the offspring .
METHODS	A 5-year follow-up of both mothers and their infants is planned .
CONCLUSIONS	The GeliS lifestyle intervention programme has been adapted to the existing routine health care system for pregnant women .
CONCLUSIONS	If shown to be effective , it could be immediately implemented in routine care .
BACKGROUND	The study protocol is registered at the ClinicalTrials.gov Protocol Registration System ( NCT01958307 ) .

###24827969
OBJECTIVE	Despite the popularity and an increased use of bone morphogenetic protein to improve bone healing in patients with congenital pseudoarthrosis of the tibia ( CPT ) , no previous study has compared its efficacy against any other procedure .
METHODS	We randomised 20 consecutive patients ( mean age 4.1 years ) with CPT ( Crawford type IV ) associated with neurofibromatosis type 1 ( NF1 ) and no previous history of surgery into two groups .
METHODS	Group 1 received recombinant human bone morphogenetic protein-7 ( rhBMP-7 ) along with intramedullary Kirschner ( K ) - wire fixation and autologous bone grafting ; group 2 received only K wire and grafting .
METHODS	Outcome measures were time to achieve union , Johnston grade , tibial length and the American Orthopaedic Foot and Ankle Society ( AOFAS ) score , which were evaluated preoperatively and at five year follow-up .
RESULTS	Study results showed that patients in group 1 achieved primary bone union at a mean of 14.5 months [ standard error ( SE ) 5.2 ] , whereas group 2 took a mean of 17.11 months ( SE 5.0 ) .
RESULTS	However , the log-rank test showed no difference in healing times between groups at all time points ( P = 0.636 ) .
RESULTS	There was a statistically significant pre - to post operative improvement ( P < 0.05 ) within groups for the other outcome measures .
CONCLUSIONS	In a five year follow-up , these results suggest that rh-BMP-7 and autologous bone grafting is no better than autologous grafting alone .

###24711627
BACKGROUND	Researchers have increasingly begun to gather ecological momentary assessment ( EMA ) data on smoking , but new statistical methods are necessary to fully unlock information from such data .
BACKGROUND	In this paper , we use a new technique , the logistic time-varying effect model ( logistic TVEM ) , to examine the odds of smoking in the 2 weeks after a quit attempt .
METHODS	Data are from a subsample of participants from a randomized , placebo-controlled trial of smoking cessation pharmacotherapies who achieved initial abstinence ( N = 1,106 , 58 % female ) .
METHODS	Participants completed up to 4 EMA assessments per day during the 2 weeks after their quit day .
METHODS	Predictors include baseline nicotine dependence , EMA measures of craving and negative affect , and whether an individual was assigned to a placebo , monotherapy , or combination therapy condition .
METHODS	Time-varying effects of these predictors were estimated using logistic TVEM .
RESULTS	Cravings were a significant predictor of smoking throughout the entire 2 weeks postquit , whereas the effect of baseline dependence became nonsignificant by the second week , and the effect of negative affect increased over time .
RESULTS	Individuals in the monotherapy and combination therapy conditions had decreased odds of smoking compared with placebo in the first week postquit , but these differences were nonsignificant in the second week .
CONCLUSIONS	Findings suggest that pharmacotherapies are more effective compared with placebo earlier in a quit attempt , when the effect of baseline nicotine dependence on smoking is stronger , whereas the effect of craving and negative affect increased over time .
CONCLUSIONS	Future cessation therapies may be more successful by providing additional support in the second week after quit attempt .

###25066331
BACKGROUND	Hospital-acquired pneumonia is common after traumatic brain injury , and might be partly a result of traumatic brain injury-induced adrenal insufficiency .
BACKGROUND	We tested the efficacy of low-dose hydrocortisone with fludrocortisone for the prevention of hospital-acquired pneumonia .
METHODS	We did this double-blind , phase 3 , placebo-controlled trial in 19 intensive care units in France .
METHODS	We enrolled patients aged 15-65 years in the first 24 h after severe traumatic brain injury ( Glasgow coma scale score 8 and trauma-associated lesion on brain CT scan ) .
METHODS	Patients were randomly assigned ( 1:1 ; fixed blocks of 12 , stratified by centre and mechanism , Glasgow coma scale , age , and arterial pressure [ MGAP ] score ) to receive either hydrocortisone ( 200 mg per day tapered ) and fludrocortisone ( 50 g tablet once per day ) or matching placebo for 10 days .
METHODS	Before receiving study drug , adrenal function was assessed with a short corticotropin test .
METHODS	Treatment was stopped if patients had no adrenal insufficiency .
METHODS	The primary outcome was the occurrence of hospital-acquired pneumonia within 28 days after randomisation .
METHODS	We did an intention-to-treat analysis and a modified intention-to-treat analysis including only patients with adrenal insufficiency ( adjusted for etomidate use ) .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01093261 .
RESULTS	From Sept 1 , 2010 , to Nov 29 , 2012 , we enrolled 336 patients ( 168 assigned to each group ) .
RESULTS	Eight patients withdrew consent .
RESULTS	At day 28 , 74 of 165 patients ( 45 % ) in the steroid group and 87 of 163 ( 53 % ) in the placebo group had developed one or more episodes of hospital-acquired pneumonia ( hazard ratio [ HR ] 0.75 ; 95 % CI 0.55-1 .03 , p = 0.07 ) .
RESULTS	In intention-to-treat analysis , we recorded 86 episodes of hospital-acquired pneumonia in the steroid group versus 110 in the placebo group ( median 0 , IQR 0-1 vs median 1 , IQR 0-1 cases per patient , p = 0.07 ) .
RESULTS	In modified intention-to-treat analyses , the HR for hospital-acquired pneumonia with steroids versus placebo was 0.80 ( 95 % CI 0.56-1 .14 , p = 0.22 ) in patients with adrenal insufficiency , and , in an exploratory preplanned analysis , 048 ( 023-101 ; p = 005 ) in patients with normal adrenal function .
RESULTS	We recorded no adverse events related to treatment .
CONCLUSIONS	Low-dose hydrocortisone with fludrocortisone did not improve the outcome of patients with traumatic brain injury .
CONCLUSIONS	However , the study was underpowered because the proportion of patients with hospital-acquired pneumonia in the placebo group was lower than expected .
CONCLUSIONS	The results were close to statistical significance for efficacy , meaning that further studies are therefore needed .
BACKGROUND	Socit Franaise d'Anesthsie Ranimation .

###24785602
OBJECTIVE	To determine whether social media , specifically Facebook , is an effective tool for improving contraceptive knowledge .
METHODS	English-speaking women aged 18-45 years receiving care at an urban academic center obstetrics and gynecology clinic were included and randomized to a trial of standard contraceptive education and pamphlet ( n = 74 ) compared with standard contraceptive education and Facebook ( n = 69 ) information for contraception counseling .
METHODS	Contraceptive knowledge was evaluated preintervention and postintervention by the Contraceptive Knowledge Inventory .
METHODS	We evaluated the effect of the intervention by raw score and percent increase in Contraceptive Knowledge Inventory score , participant satisfaction with counseling method , and contraceptive preference postintervention .
METHODS	All analyses were stratified by age group .
RESULTS	The median raw postintervention Contraceptive Knowledge Inventory score was significantly higher in the Facebook compared with the pamphlet group ( 15 compared with 12 , P < .001 ) as was percentage increase in the Contraceptive Knowledge Inventory score ( 36 % compared with 12 % , P < .001 ) .
RESULTS	Participant satisfaction with counseling method was significantly higher in the Facebook group ( median 10 compared with 6 , P < .001 ) .
RESULTS	Participant contraceptive preference for long-acting reversible contraceptives ( LARCs ; intrauterine device or implant ) postintervention was significantly greater in the Facebook compared with the pamphlet group ( 57 % compared with 35 % , P = .01 ) .
RESULTS	Among women currently using none or barrier contraception , contraceptive preference for implants was significantly greater in the Facebook compared with the pamphlet group ( 26 % compared with 5 % , P = .02 ) , although , when analysis was extended to include implant or intrauterine device , LARCs were not significantly higher in the Facebook compared with the pamphlet group ( 48 % compared with 33 % , P = .19 ) .
CONCLUSIONS	Social media as an adjunct to traditional in-office counseling improves patient contraceptive knowledge and increases patient preference for LARCs .
BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT5327714500 .

###25164452
BACKGROUND	Multiple micronutrient deficiencies are prevalent in India .
OBJECTIVE	The study aims to establish the efficacy of multi-micronutrient fortified salt in addressing multiple micronutrient deficiencies among children compared to nutrition education and no intervention in Tamilnadu .
METHODS	The study employed a community based randomized controlled trial designed to study the impact of multiple micronutrient salt ( micronutrient group ) in comparison with nutrition education ( education group ) and no intervention ( control group ) on haemoglobin , serum ferritin , soluble transferrin receptor , body iron stores , serum retinol and urinary iodine outcomes over a period of 8 months .
METHODS	The fortified salt contained iron , iodine , vitamin A , vitamin B12 and folic acid .
METHODS	All the children were dewormed at baseline and at the end of the study just before the biochemical measurements .
RESULTS	There was a significant improvement in most biochemical parameters studied in the micronutrient group when compared with the control group whereas this was not seen between the education and control .
RESULTS	Over 8 months , in the micronutrient group , hemoglobin increased by 0.52 g/dL , retinol by 8.56 g/dL , ferritin by 10.8 g/L , body iron stores by 1.27 mg and the decrease in the prevalence of retinol deficiency was from 51.6 % to 28.1 % , anaemia from 46.0 % to 32.6 % , iron deficiency from 66.9 % to 51.3 % and iron deficiency anaemia from 35.2 % to 31.0 % , while the prevalence of all these deficiencies increased or the changes were not significant in the other two groups .
CONCLUSIONS	Multiple micronutrient fortified salt was able to improve iron and vitamin A status , whereas this was not seen in the nutrition education group .

###24522623
BACKGROUND	Home wireless device monitoring could play an important role in improving the health of patients with poorly controlled chronic diseases , but daily engagement rates among these patients may be low .
OBJECTIVE	To test the effectiveness of two different magnitudes of financial incentives for improving adherence to remote-monitoring regimens among patients with poorly controlled diabetes .
METHODS	Randomized , controlled trial .
METHODS	( Clinicaltrials.gov Identifier : NCT01282957 ) .
METHODS	Seventy-five patients with a hemoglobin A1c greater than or equal to 7.5 % recruited from a Primary Care Medical Home practice at the University of Pennsylvania Health System .
METHODS	Twelve weeks of daily home-monitoring of blood glucose , blood pressure , and weight ( control group ; n = 28 ) ; a lottery incentive with expected daily value of $ 2.80 ( n = 26 ) for daily monitoring ; and a lottery incentive with expected daily value of $ 1.40 ( n = 21 ) for daily monitoring .
METHODS	Daily use of three home-monitoring devices during the three-month intervention ( primary outcome ) and during the three-month follow-up period and change in A1c over the intervention period ( secondary outcomes ) .
RESULTS	Incentive arm participants used devices on a higher proportion of days relative to control ( 81 % low incentive vs. 58 % , P = 0.007 ; 77 % high incentive vs. 58 % , P = 0.02 ) during the three-month intervention period .
RESULTS	There was no difference in adherence between the two incentive arms ( P = 0.58 ) .
RESULTS	When incentives were removed , adherence in the high incentive arm declined while remaining relatively high in the low incentive arm .
RESULTS	In month 6 , the low incentive arm had an adherence rate of 62 % compared to 35 % in the high incentive arm ( P = 0.015 ) and 27 % in the control group ( P = 0.002 ) .
CONCLUSIONS	A daily lottery incentive worth $ 1.40 per day improved monitoring rates relative to control and had significantly better efficacy once incentives were removed than a higher incentive .

###24532260
METHODS	Urolithins are bioactive metabolites produced by the gut microbiota from ellagitannins ( ETs ) and ellagic acid ( EA ) .
METHODS	We investigated whether urolithins could be detected in colon tissues from colorectal cancer ( CRC ) patients after pomegranate extract ( PE ) intake .
RESULTS	CRC patients ( n = 52 ) were divided into controls and PEs consumers ( 900 mg/day for 15 days ) before surgical resection .
RESULTS	PEs with low ( PE-1 ) and high ( PE-2 ) punicalagin : EA ratio were administered .
RESULTS	Twenty-three metabolites , but no ellagitannins , were detected in urine , plasma , normal ( NT ) or malignant ( MT ) colon tissues using UPLC-ESI-QTOF-MS / MS ( UPLC , ultra performance liquid chromatography ; QTOF , quadrupole TOF ) .
RESULTS	Free EA , five EA conjugates , gallic acid and 12 urolithin derivatives were found in colon tissues .
RESULTS	Individual and total metabolites levels were higher in NT than in MT , independently of the PE consumed .
RESULTS	The maximal mean concentration ( 1671 367 ng/g ) was found in NT after consumption of PE-1 and the lowest concentration ( 42.4 10.2 ng/g ) in MT with PE-2 .
RESULTS	Urolithin A or isourolithin A were the main urolithins produced ( 54 and 46 % patients with urolithin A or isourolithin A phenotype , respectively ) .
RESULTS	High punicalagin content ( PE-2 ) hampered urolithins formation .
CONCLUSIONS	Significant levels of EA derivatives and urolithins are found in human colon tissues from CRC patients after consumption of pomegranate .
CONCLUSIONS	Further studies are warranted to elucidate their biological activity .

###25480673
BACKGROUND	Chronic kidney disease is a common disease .
BACKGROUND	Most chronic kidney diseases evolve from primary glomerulonephritis .
BACKGROUND	Proteinuria is an independent risk factor for the progression of chronic kidney disease .
BACKGROUND	The general consensus is that therapy administered to decrease proteinuria should include steroids and/or immunosuppressants , angiotensin-converting enzyme inhibitors , and angiotensin II receptor blockers .
BACKGROUND	However , the side effects of , and adverse reactions to , these agents reduce the benefits to patients .
BACKGROUND	In addition , the cost of these drugs is relatively high .
BACKGROUND	Therefore , identification of inexpensive and effective drugs to decrease proteinuria is urgently needed .
BACKGROUND	Shenyankangfu tablets have been a widely applied Chinese patent medicine for many years to decrease proteinuria .
BACKGROUND	However , there is a lack of research-derived data regarding the clinical use .
BACKGROUND	Therefore , we designed the present randomized controlled clinical trial to compare the efficacy and safety of Shenyankangfu tablets versus losartan potassium for control of proteinuria in patients with primary glomerulonephritis .
METHODS	This study will be a multicenter , prospective , double-blind , double-dummy , randomized controlled clinical trial .
METHODS	We will enroll 720 patients diagnosed with primary glomerulonephritis .
METHODS	The eligible patients will be randomly divided into the following groups at a 1:1:1:1:1 ratio : Shenyankangfu tablets group , losartan potassium 50 mg group , losartan potassium 100 mg group , Shenyankangfu tablets + losartan potassium 50 mg group , and Shenyankangfu tablets + losartan potassium 100 mg group .
METHODS	All groups will be followed up for 48 weeks ; follow-up visits will be performed , at weeks 0 , 4 , 8 , 12 , 24 , 36 , and 48 .
METHODS	The primary efficacy outcome will be the post-treatment change in the 24-hour proteinuria level , and the secondary efficacy outcomes will be the post-treatment changes in the serum creatinine level , estimated glomerular filtration rate , traditional Chinese medicine syndrome score , and serum albumin level .
CONCLUSIONS	The results of this trial will provide solid data for use in evidence-based medicine with respect to the efficacy and safety of Shenyankangfu tablets for control of proteinuria in patients with primary glomerulonephritis compared to those of losartan potassium .
CONCLUSIONS	Moreover , we infer that therapy comprising Shenyankangfu tablets + losartan potassium can decrease proteinuria to a larger extent than Shenyankangfu tablets or losartan potassium can alone .
BACKGROUND	This trial was registered on 12 February 2014 at ClinicalTrials.gov ( ID number NCT02063100 ) .

###25782644
BACKGROUND	Sufficient pain treatment remains a challenge after total knee arthroplasty ( TKA ) , especially in high pain catastrophizing patients .
BACKGROUND	Serotonergic signaling may be involved in pain processing , but the effect of selective serotonin reuptake inhibitors on well-defined postoperative pain has not previously been investigated .
BACKGROUND	The authors hypothesized that perioperative escitalopram would reduce pain after TKA in high pain catastrophizing patients .
METHODS	A total of 120 pain catastrophizing patients ( selected using the pain catastrophizing scale as preoperative screening tool ) scheduled for TKA were randomized in a double-blind manner to either 10 mg escitalopram or placebo daily from preanesthesia to postoperative day 6 in addition to a standardized analgesic regime .
METHODS	The primary outcome was pain upon ambulation 24 h after surgery .
METHODS	Secondary outcomes were overall pain during well-defined mobilizations and at rest from 2 to 48 h and from days 2 to 6 , morphine equivalents , anxiety , depression , and side effects .
RESULTS	Pain upon ambulation ( mean [ 95 % CI ] ) 24 h after surgery in the escitalopram versus placebo group was 58 ( 53 to 64 ) versus 64 ( 58 to 69 ) , the mean difference being -5 ( -13 to 3 ) , P = 0.20 .
RESULTS	Overall pain upon ambulation and at rest from days 2 to 6 was lower in the escitalopram versus placebo group , as was depression score at day 6 ( all P 0.01 in analyses uncorrected for multiple tests ) .
RESULTS	Side effects were nonsignificant except for reduced tendency to sweat and prolonged sleep in the escitalopram group .
RESULTS	No other between-group differences were observed .
CONCLUSIONS	Escitalopram did not reduce pain upon ambulation 24 h after TKA in high pain catastrophizing patients .
CONCLUSIONS	Future studies on optimal timing , dose , and duration of selective serotonin reuptake inhibitor treatment might be warranted .

###25545453
OBJECTIVE	To evaluate the effects of almost continuous skin-to-skin contact ( SSC ) on salivary cortisol , parental stress , parental depression , and breastfeeding .
METHODS	This is a randomised study engaging families of late preterm infants ( 32-35 weeks gestation ) .
METHODS	Salivary cortisol reactivity was measured in infants during a nappy change at one month corrected age , and in infants and mothers during still-face at four month corrected age .
METHODS	Both parents completed the Swedish Parenthood Stress Questionnaire ( SPSQ ) at one month and the Edinburgh Postnatal Depression Scale ( EPDS ) at one and four months .
METHODS	Ainsworth 's sensitivity scale was used to control for parental sensitivity .
METHODS	Thirty-seven families from two different neonatal care units in Sweden , randomised to either almost continuous SSC or standard care ( SC ) .
RESULTS	Infants randomised to SSC had a lower salivary cortisol reactivity at one month ( p = 0.01 ) .
RESULTS	There was a correlation between the mothers ' and the preterm infants ' salivary cortisol levels at four months in the SSC group ( = 0.65 , p = 0.005 ) , but not in the SC group ( = 0.14 , p = 0.63 ) .
RESULTS	Fathers in SSC scored lower on the SPSQ sub-scale spouse relationship problems compared to fathers in SC ( p < 0.05 ) .
CONCLUSIONS	Almost continuous SSC decreases infants ' cortisol reactivity in response to handling , improves the concordance between mothers ' and infants ' salivary cortisol levels , and decreases fathers ' experiences of spouse relationship problems .

###25306451
OBJECTIVE	The purpose of this study was to evaluate the influence of the guanine nucleotide-binding proteins ( G-proteins ) , beta-3 subunit ( GNB3 ) genotype on the effectiveness of a fixed-dose combination of isosorbide dinitrate and hydralazine ( FDC I/H ) in A-HeFT ( African American Heart Failure Trial ) .
BACKGROUND	GNB3 plays a role in alpha2-adrenergic signaling .
BACKGROUND	A polymorphism ( C825T ) exists , and the T allele is linked to enhanced alpha-adrenergic tone and is more prevalent in African Americans .
METHODS	A total of 350 subjects enrolled in the genetic substudy ( GRAHF [ Genetic Risk Assessment of Heart Failure in African Americans ] ) were genotyped for the C825T polymorphism .
METHODS	The impact of FDC I/H on a composite score ( CS ) that incorporated death , hospital stay for heart failure , and change in quality of life ( QoL ) and on event-free survival were assessed in GNB3 genotype subsets .
RESULTS	The GRAHF cohort was 60 % male , 25 % ischemic , 97 % New York Heart Association functional class III , age 57 13 years , with a mean qualifying left ventricular ejection fraction of 0.24 0.06 .
RESULTS	For GNB3 genotype , 184 subjects were TT ( 53 % ) , 137 ( 39 % ) CT , and 29 ( 8 % ) were CC .
RESULTS	In GNB3 TT subjects , FDC I/H improved the CS ( FDC I/H = 0.50 1.6 ; placebo = -0.11 1.8 , p = 0.02 ) , QoL ( FDC I/H = 0.69 1.4 ; placebo = 0.24 1.5 , p = 0.04 ) , and event-free survival ( hazard ratio : 0.51 , p = 0.047 ) , but not in subjects with the C allele ( for CS , FDC I/H = -0.05 1.7 ; placebo = -0.09 1.7 , p = 0.87 ; for QoL , FDC I/H = 0.28 1.5 ; placebo = 0.14 1.5 , p = 0.56 ; and for event-free survival , p = 0.35 ) .
CONCLUSIONS	The GNB3 TT genotype was associated with greater therapeutic effect of FDC I/H in A-HeFT .
CONCLUSIONS	The role of the GNB3 genotype for targeting therapy with FDC I/H deserves further study .

###25363170
BACKGROUND	Chronic media otitis is a common cause of reference to ear , nose and throat clinics and the treatment is one of the health problems among ENT specialists .
BACKGROUND	Ciprofloxacin drop that is of fluoroquinolone drug class due to good treatment effect is now widely used in the treatment of chronic media otitis .
BACKGROUND	Due to the widespread use , it seems proper research on the human population has not been taken to ensure its non-toxicity in the inner ear , therefore comparison of local ciprofloxacin ototoxicity with systemic in chronic media otitis is investigated in this study .
METHODS	This study was conducted as a randomized clinical trial .
METHODS	Prospective methods were considered and the number of samples in the study group was 40 patients that were treated with ciprofloxacin drops .
METHODS	And in the control group 32 patients with chronic media otitis who were treated with ciprofloxacin tablets .
METHODS	The collected data was analyzed using SPSS software .
RESULTS	Statistical indicators of different frequencies in air conduction ( AC ) in both groups showed , there was significant improvement in hearing thresholds at frequencies of 250 , 8000 , 1000 in air conduction for the group receiving drops compared to the group receiving tablet .
RESULTS	Based on statistical indicators in different frequencies of bone conduction in the two treated groups , there was significant difference in the two groups receiving tablets and drops only at a frequency of 4000 Hz that drop impact improves hearing threshold and in contrast in the group receiving tablet hearing loss was seen in the frequency of 4000 .
CONCLUSIONS	Topical ciprofloxacin is a safe and uncomplicated ototoxic drug that is an effective antibiotic used in the treatment of refractory chronic otitis those dregs such as pseudomonas aerogenusa and staphylococci resistant to methicillin are responsible for it , which in the usual doses has not harmful effects on hearing hairy cells .

###25076007
BACKGROUND	The preoperative period ( prehabilitation ) may represent a more appropriate time than the postoperative period to implement an intervention .
BACKGROUND	The impact of prehabilitation on recovery of function al exercise capacity was thus studied in patients undergoing colorectal resection for cancer .
METHODS	A parallel-arm single-blind superiority randomized controlled trial was conducted .
METHODS	Seventy-seven patients were randomized to receive either prehabilitation ( n = 38 ) or rehabilitation ( n = 39 ) .
METHODS	Both groups received a home-based intervention of moderate aerobic and resistance exercises , nutritional counseling with protein supplementation , and relaxation exercises initiated either 4 weeks before surgery ( prehabilitation ) or immediately after surgery ( rehabilitation ) , and continued for 8 weeks after surgery .
METHODS	Patients were managed with an enhanced recovery pathway .
METHODS	Primary outcome was functional exercise capacity measured using the validated 6-min walk test .
RESULTS	Median duration of prehabilitation was 24.5 days .
RESULTS	While awaiting surgery , functional walking capacity increased ( 20 m ) in a higher proportion of the prehabilitation group compared with the rehabilitation group ( 53 vs. 15 % , adjusted P = 0.006 ) .
RESULTS	Complication rates and duration of hospital stay were similar .
RESULTS	The difference between baseline and 8-week 6-min walking test was significantly higher in the prehabilitation compared with the rehabilitation group ( +23.7 m [ SD , 54.8 ] vs. -21.8 m [ SD , 80.7 ] ; mean difference 45.4 m [ 95 % CI , 13.9 to 77.0 ] ) .
RESULTS	A higher proportion of the prehabilitation group were also recovered to or above baseline exercise capacity at 8 weeks compared with the rehabilitation group ( 84 vs. 62 % , adjusted P = 0.049 ) .
CONCLUSIONS	Meaningful changes in postoperative functional exercise capacity can be achieved with a prehabilitation program .

###25682816
BACKGROUND	In low-income settings , many women and girls face activity restrictions during menses , owing to lack of affordable menstrual products .
BACKGROUND	The menstrual cup ( MC ) is a nonabsorbent reusable cup that collects menstrual blood .
BACKGROUND	We assessed the acceptability and performance of the MPower MC compared to pads or tampons among women in a low-resource setting .
METHODS	We conducted a randomized two-period crossover trial at one site in Durban , South Africa , between January and November 2013 .
METHODS	Participants aged 18-45 years with regular menstrual cycles were eligible for inclusion if they had no intention of becoming pregnant , were using an effective contraceptive method , had water from the municipal system as their primary water source , and had no sexually transmitted infections .
METHODS	We used a computer-generated randomization sequence to assign participants to one of two sequences of menstrual product use , with allocation concealed only from the study investigators .
METHODS	Participants used each method over three menstrual cycles ( total 6 months ) and were interviewed at baseline and monthly follow-up visits .
METHODS	The product acceptability outcome compared product satisfaction question scores using an ordinal logistic regression model with individual random effects .
METHODS	This study is registered on the South African Clinical Trials database : number DOH-27-01134273 .
RESULTS	Of 124 women assessed , 110 were eligible and randomly assigned to selected menstrual products .
RESULTS	One hundred and five women completed all follow-up visits .
RESULTS	By comparison to pads/tampons ( usual product used ) , the MC was rated significantly better for comfort , quality , menstrual blood collection , appearance , and preference .
RESULTS	Both of these comparative outcome measures , along with likelihood of continued use , recommending the product , and future purchase , increased for the MC over time .
CONCLUSIONS	MC acceptance in a population of novice users , many with limited experience with tampons , indicates that there is a pool of potential users in low-resource settings .

###25671797
BACKGROUND	Trials of endovascular therapy for ischemic stroke have produced variable results .
BACKGROUND	We conducted this study to test whether more advanced imaging selection , recently developed devices , and earlier intervention improve outcomes .
METHODS	We randomly assigned patients with ischemic stroke who were receiving 0.9 mg of alteplase per kilogram of body weight less than 4.5 hours after the onset of ischemic stroke either to undergo endovascular thrombectomy with the Solitaire FR ( Flow Restoration ) stent retriever or to continue receiving alteplase alone .
METHODS	All the patients had occlusion of the internal carotid or middle cerebral artery and evidence of salvageable brain tissue and ischemic core of less than 70 ml on computed tomographic ( CT ) perfusion imaging .
METHODS	The coprimary outcomes were reperfusion at 24 hours and early neurologic improvement ( 8-point reduction on the National Institutes of Health Stroke Scale or a score of 0 or 1 at day 3 ) .
METHODS	Secondary outcomes included the functional score on the modified Rankin scale at 90 days .
RESULTS	The trial was stopped early because of efficacy after 70 patients had undergone randomization ( 35 patients in each group ) .
RESULTS	The percentage of ischemic territory that had undergone reperfusion at 24 hours was greater in the endovascular-therapy group than in the alteplase-only group ( median , 100 % vs. 37 % ; P < 0.001 ) .
RESULTS	Endovascular therapy , initiated at a median of 210 minutes after the onset of stroke , increased early neurologic improvement at 3 days ( 80 % vs. 37 % , P = 0.002 ) and improved the functional outcome at 90 days , with more patients achieving functional independence ( score of 0 to 2 on the modified Rankin scale , 71 % vs. 40 % ; P = 0.01 ) .
RESULTS	There were no significant differences in rates of death or symptomatic intracerebral hemorrhage .
CONCLUSIONS	In patients with ischemic stroke with a proximal cerebral arterial occlusion and salvageable tissue on CT perfusion imaging , early thrombectomy with the Solitaire FR stent retriever , as compared with alteplase alone , improved reperfusion , early neurologic recovery , and functional outcome .
CONCLUSIONS	( Funded by the Australian National Health and Medical Research Council and others ; EXTEND-IA ClinicalTrials.gov number , NCT01492725 , and Australian New Zealand Clinical Trials Registry number , ACTRN12611000969965 . )

###26063507
BACKGROUND	The benefits of aerobic training for the main features of asthma , such as bronchial hyperresponsiveness ( BHR ) and inflammation , are poorly understood .
BACKGROUND	We investigated the effects of aerobic training on BHR ( primary outcome ) , serum inflammatory cytokines ( secondary outcome ) , clinical control and asthma quality of life ( Asthma Quality of Life Questionnaire ( AQLQ ) ) ( tertiary outcomes ) .
METHODS	Fifty-eight patients were randomly assigned to either the control group ( CG ) or the aerobic training group ( TG ) .
METHODS	Patients in the CG ( educational programme + breathing exercises ( sham ) ) and the TG ( same as the CG + aerobic training ) were followed for 3months .
METHODS	BHR , serum cytokine , clinical control , AQLQ , induced sputum and fractional exhaled nitric oxide ( FeNO ) were evaluated before and after the intervention .
RESULTS	After 12weeks , 43 patients ( 21 CG/22 TG ) completed the study and were analysed .
RESULTS	The TG improved in BHR by 1 doubling dose ( dd ) ( 95 % CI 0.3 to 1.7 dd ) , and they experienced reduced interleukin 6 ( IL-6 ) and monocyte chemoattractant protein 1 ( MCP-1 ) and improved AQLQ and asthma exacerbation ( p < 0.05 ) .
RESULTS	No effects were seen for IL-5 , IL-8 , IL-10 , sputum cellularity , FeNO or Asthma Control Questionnaire 7 ( ACQ-7 ; p > 0.05 ) .
RESULTS	A within-group difference was found in the ACQ-6 for patients with non-well-controlled asthma and in sputum eosinophil and FeNO in patients in the TG who had worse airway inflammation .
CONCLUSIONS	Aerobic training reduced BHR and serum proinflammatory cytokines and improved quality of life and asthma exacerbation in patients with moderate or severe asthma .
CONCLUSIONS	These results suggest that adding exercise as an adjunct therapy to pharmacological treatment could improve the main features of asthma .
BACKGROUND	NCT02033122 .

###25410885
BACKGROUND	Biochemical failure ( BF ) after radiation therapy is defined on the basis of a rising prostate-specific antigen ( PSA ) level ( A1 failure ) or any event that prompts the initiation of salvage androgen-deprivation therapy without PSA failure ( A2 ) .
BACKGROUND	It was hypothesized that A2 failure may have a different prognosis .
METHODS	Data for 2799 eligible patients from Radiation Therapy Oncology Group ( RTOG ) 9202 and RTOG 9413 were analyzed .
METHODS	BF was defined according to the 1997 American Society for Therapeutic Radiology and Oncology consensus definition as A1 for PSA failure or as A2 for the start of salvage hormone therapy before 3 consecutive PSA rises .
RESULTS	Rates of all-cause mortality ( hazard ratio [ HR ] , 1.7 ; 95 % confidence interval [ CI ] , 1.5-2 .0 ; P < .0001 ) and distant metastasis ( DM ; HR , 1.6 ; 95 % CI , 1.3-2 .0 ; P < .0001 ) were greater with A2 failure .
RESULTS	The 5-year overall survival ( OS ) rates were 88.2 % and 74.6 % for A1 and A2 , respectively ( P < .0001 ) , and the DM rates were 15.7 % and 29.0 % , respectively ( P < .0001 ) .
RESULTS	The DM rate was greater at 5 years for A2 patients with DM as the first sign of failure versus patients with other A2 failures ( 87.3 % vs 11.7 % , P < .001 ) , and this also correlated with worse OS at 5 years : 81.1 % for A2 failure without DM and 52.8 % with DM ( P < .001 ) .
RESULTS	After the removal of patients with DM , the difference between A1 and A2 BF persisted for OS ( P = .002 ) but not for DM ( P = .16 ) CONCLUSIONS : These results suggest that patients with rising PSA levels alone have less risk than those with A2 failures ; although DM was the largest contributor of adverse risk to A2 failure , it did not account for all excess risk in A2 failure .

###24491076
OBJECTIVE	The purpose of this study was to evaluate the efficacy of personalized normative feedback ( PNF ) on college student alcohol-related risky sexual behavior ( RSB ) .
METHODS	In a randomized controlled trial , 480 ( 57.6 % female ) sexually active college students were stratified by gender and level of drinking and randomly assigned to an alcohol-only intervention , an alcohol-related RSB-only intervention , a combined alcohol and alcohol-related RSB intervention , or control .
METHODS	All assessment and intervention procedures were Web-based .
RESULTS	Results indicated a significant reduction in drinking outcomes for the alcohol only and the combined alcohol and alcohol-related RSB interventions relative to control .
RESULTS	Findings further demonstrated a significant reduction in alcohol-related RSB outcomes for the alcohol-related RSB only and the combined alcohol and alcohol-related RSB interventions relative to control .
RESULTS	There were no significant intervention effects on alcohol-related negative consequences .
RESULTS	These findings demonstrate that the combined alcohol and alcohol-related RSB intervention was the only intervention successful at reducing both drinking and alcohol-related RSB outcomes relative to control .
RESULTS	There were no significant differences when comparing the combined alcohol and alcohol-related RSB intervention to the alcohol-only intervention or the alcohol-related RSB-only intervention .
RESULTS	Finally , results suggested that the intervention effects on high-risk behaviors were mediated by reductions in descriptive normative perceptions .
CONCLUSIONS	These findings demonstrate that PNF specific to drinking in sexual situations was needed to reduce alcohol-related RSB .
CONCLUSIONS	Furthermore , this study highlights the potential utility of a brief intervention that can be delivered via the Internet to reduce high-risk drinking and alcohol-related RSB among college students .

###24841327
BACKGROUND	There is increasing interest in the earlier detection of , and intervention in , patients at highest risk of developing chronic obstructive pulmonary disease ( COPD ) .
OBJECTIVE	The objective of this research was to develop and validate a risk prediction model for general practitioner ( GP ) - recorded diagnosis of COPD .
METHODS	We used data from 239 Scottish GP practices ; two-thirds were randomly allocated to a derivation cohort and the other third to a validation cohort .
METHODS	We included patients aged 35-74 years at the cohort entry date , and excluded patients with a recorded diagnosis of COPD prior to the entry date and with missing data on smoking status .
RESULTS	There were 480,903 patients in the derivation cohort and 247,755 in the validation cohort .
RESULTS	The incidence of COPD in the total cohort was 5.53 / 1,000 patient-years of follow-up ( 95 % confidence interval ( CI ) , 5.46-5 .60 ) .
RESULTS	In the derivation cohort , the COPD risk for ever - versus never-smokers was substantially higher in women ( hazard ratio ( HR ) = 9.61 , 95 % CI , 8.92-10 .34 ) than in men ( HR = 6.72 , 95 % CI , 6.19-7 .30 ) .
RESULTS	Other risk factors for both sexes were level of deprivation and a previously recorded asthma diagnosis .
RESULTS	In the validation cohort , the model discriminated well between patients who did and those who did not develop COPD : area under the receiver operating characteristics curve = 0.845 ( 95 % CI , 0.840-0 .850 ) for females and 0.832 ( 95 % CI , 0.827-0 .837 ) for males .
CONCLUSIONS	We have developed and validated the first risk prediction model for COPD , which has the major advantage of being populated entirely by routinely collected data and consequently may be used for clinical practice .

###25210141
BACKGROUND	Bacillus Calmette-Gurin ( BCG ) seems to have beneficial nonspecific effects ; early BCG vaccination of low-birth-weight ( LBW ) newborns reduces neonatal mortality by > 40 % due to prevention of primarily septicemia and pneumonia .
METHODS	Within a randomized trial in LBW infants in Guinea-Bissau of early BCG vs the usual postponed BCG , a subgroup was bled 4 weeks after randomization .
METHODS	Levels of interleukin ( IL ) -1 , IL-5 , IL-6 , IL-10 , IL-17 , interferon ( IFN ) - and tumor necrosis factor ( TNF ) - were measured from whole-blood assays stimulated with innate agonists to Toll-like receptor ( TLR ) -2 , -4 or -7 / 8 , or purified protein derivative ( PPD ) .
RESULTS	Among 467 infants , BCG significantly increased the in vitro cytokine responses to purified protein derivative of Mycobacterium tuberculosis ( PPD ) , as expected .
RESULTS	BCG was also associated with increased responses to heterologous innate stimulation , particularly of the cytokines IL-1 , IL-6 , TNF - , and IFN - .
CONCLUSIONS	Four weeks after immunization , BCG-vaccinated infants have a significantly increased production of cytokines upon heterologous challenge , particularly T helper cell type 1 polarizing and typically monocyte-derived pro-inflammatory cytokines .
CONCLUSIONS	BCG may accelerate the development of the neonatal immune system , mediating comprehensive protection against infections and mortality .

###25012240
BACKGROUND	The aim of the prospective Homburg Cream and Sugar study was to analyze the role of fasting and postprandial serum triglycerides ( TG ) as risk modifiers in patients with coronary artery disease ( CAD ) .
RESULTS	A sequential oral triglyceride and glucose tolerance test was developed to obtain standardized measurements of postprandial TG kinetics and glucose in 514 consecutive patients with stable CAD confirmed by angiography ( 95 % were treated with a statin ) .
RESULTS	Fasting and postprandial TG predicted the primary outcome measure of cardiovascular death and hospitalizations after 48 months follow-up ( fasting TG > 150 vs. < 106 mg/dl : Hazard ratio ( HR ) 1.79 , 95 % confidence interval ( CI ) 1.31-2 .45 , p = 0.0001 ; area under the curve > 1120 vs. < 750 mg/dl/5 hr : HR 1.78 , 95 % CI 1.29-2 .45 , p = 0.0003 ) .
RESULTS	Parameters of the postprandial TG increase did not improve risk prediction compared to fasting TG .
RESULTS	The number of cardiovascular deaths and myocardial infarctions was higher in the upper tertile of fasting TG ( HR 1.79 , 95 % - CI 1.04-3 .09 , p = 0.03 ) .
RESULTS	Risk prediction by TG was independent of traditional risk factors , medication , glucose metabolism , LDL - and HDL-cholesterol .
RESULTS	Total cholesterol , LDL - and HDL-cholesterol concentrations were not associated with the primary outcome .
CONCLUSIONS	Fasting serum triglycerides > 150 mg/dl independently predict cardiovascular events in patients with coronary artery disease on guideline-recommended medication .
CONCLUSIONS	Assessment of postprandial TG does not improve risk prediction compared to fasting TG in these patients .

###25448495
OBJECTIVE	We have examined the effects of gabapentin ( GBP ) on stress-related changes of cortisol and catecholamines in patients who underwent hysterectomy because of uterine fibrinoids .
OBJECTIVE	Additionally , we have observed the effect of GBP on the immune status in the acute stress response to surgery .
METHODS	Sixty patients scheduled for an abdominal hysterectomy were randomly assigned to the GBP administration 1h before surgery ( n = 30 pts ) , or to the placebo group ( n = 30 pts ) .
METHODS	Blood samples were collected before and 24h after the surgery .
METHODS	The intensity of pain was assessed by a visual analogue scale ( VAS ) every 8h at rest .
METHODS	Immunomodulatory effects of GBP were determined by flow cytometry .
METHODS	We followed the total proportion of CD3 ( + ) lymphocytes , CD3 ( + ) CD4 ( + ) , CD3 ( + ) CD8 ( + ) , CD19 ( + ) B lymphocytes , CD16 ( + ) CD56 ( + ) CD3 ( - ) NK cells and CD16 ( + ) CD56 ( + ) CD3 ( + ) NKT cells before and 24h after hysterectomy .
METHODS	The plasma cortisol and catecholamines concentration was used to estimate the level of the stress response .
RESULTS	VAS pain score at rest was significantly lower in the GBP group than in the placebo group ( P = 0.003 ) .
RESULTS	Application of GBP significantly decreased the plasma cortisol level 24h after the operation in comparison to the placebo group ( P < 0,001 ) .
RESULTS	We found significant positive correlation between the VAS pain score and concentration of cortisol in all patients ( P = 0.025 ) .
RESULTS	GBP reduced the concentration of catecholamines ( p < 0.05 ) .
RESULTS	The proportion of CD3 ( + ) ( P = 0.027 ) and CD3 ( + ) CD4 ( + ) cells ( P = 0.006 ) was significantly lower in the GBP group 24h after operation , while the contribution of CD19 ( + ) ( P = 0.033 ) was significantly higher .
CONCLUSIONS	Preoperative administration of GBP reduced the pain scores at rest in patients at 0 , 16 and 24h after abdominal hysterectomy .
CONCLUSIONS	Additionally , GBP reduced the stress response and changed immune parameters in the reaction to surgery .

###24918481
OBJECTIVE	The aim of the current study was to directly investigate whether active gas suction reduces intraperitoneal residual carbon dioxide and to analyze the effect of active gas suction on postoperative pain after laparoscopic cholecystectomy .
METHODS	This prospective , randomized clinical study included patients between 19 and 65 years of age with gallbladder disease who were eligible for elective laparoscopic cholecystectomy .
METHODS	Patients were allocated into either the natural evacuation group ( NE group ) or the active suction group ( AS group ) .
METHODS	In the AS group , active suction was applied by inserting the laparoscopic suction irrigation device through a 5-mm trocar for 60 seconds at the end of surgery .
METHODS	A chest X-ray was taken at postoperative Day 1 , and the residual intraabdominal gas volume was measured .
METHODS	Perioperative data including pain score and analgesic requirement were collected .
RESULTS	Thirty-nine patients were allocated to the NE group , and 36 were allocated to the AS group .
RESULTS	There was no statistically significant difference between the two groups in terms of demographic data and operative findings .
RESULTS	However , a significant difference was observed in the residual intraperitoneal gas volume , with 15.96.8 mL in the NE group and 6.74.0 mL in the AS group ( P < .001 ) .
RESULTS	Significant differences were also observed in the pain scores measured 6 hours after surgery , on postoperative Day 1 , and on postoperative Day 2 .
CONCLUSIONS	Active gas suction is a very simple procedure that is safe and feasible .
CONCLUSIONS	Performing this procedure significantly decreases the residual intraperitoneal gas volume and postoperative pain after laparoscopic surgery .

###25085960
BACKGROUND	The Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery ( SYNTAX ) trial demonstrated that in patients with 3-vessel or left main coronary artery disease , coronary artery bypass graft surgery ( CABG ) was associated with a lower rate of cardiovascular death , myocardial infarction , stroke , or repeat revascularization compared with percutaneous coronary revascularization with drug-eluting stents ( DES-PCI ) ) .
BACKGROUND	The long-term cost-effectiveness of these strategies is unknown .
RESULTS	Between 2005 and 2007 , 1800 patients with left main or 3-vessel coronary artery disease were randomized to CABG ( n = 897 ) or DES-PCI ( n = 903 ) .
RESULTS	Costs were assessed from a US perspective , and health state utilities were evaluated with the EuroQOL questionnaire .
RESULTS	A patient-level microsimulation model based on the 5-year in-trial data was used to extrapolate costs , life expectancy , and quality-adjusted life expectancy over a lifetime horizon .
RESULTS	Although initial procedural costs were $ 3415 per patient lower with CABG , total hospitalization costs were $ 10 036 per patient higher .
RESULTS	Over the next 5 years , follow-up costs were higher with DES-PCI as a result of more frequent hospitalizations , revascularization procedures , and higher medication costs .
RESULTS	Over a lifetime horizon , CABG remained more costly than DES-PCI , but the incremental cost-effectiveness ratio was favorable ( $ 16 537 per quality-adjusted life-year gained ) and remained < $ 20 000 per quality-adjusted life-year in most bootstrap replicates .
RESULTS	Results were consistent across a wide range of assumptions about the long-term effect of CABG versus DES-PCI on events and costs .
RESULTS	In patients with left main disease or a SYNTAX score 22 , however , DES-PCI was economically dominant compared with CABG , although these findings were less certain .
CONCLUSIONS	For most patients with 3-vessel or left main coronary artery disease , CABG is a clinically and economically attractive revascularization strategy compared with DES-PCI .
CONCLUSIONS	However , among patients with less complex disease , DES-PCI may be preferred on both clinical and economic grounds .
BACKGROUND	www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00114972 .

###25027585
BACKGROUND	Circulating endothelial progenitor cells ( EPCs ) reflect endothelial repair capacity and may be a significant marker for the clinical outcomes of cardiovascular disease .
BACKGROUND	While some high-dose statin treatments may improve endothelial function , it is not known whether different statins may have similar effects on EPCs.This study aimed to investigate the potential class effects of different statin treatment including pitavastatin and atorvastatin on circulating EPCs in clinical setting .
METHODS	A pilot prospective , double-blind , randomized study was conducted to evaluate the ordinary dose of pitavastatin ( 2mg daily ) or atorvastatin ( 10mg daily ) treatment for 12weeks on circulating EPCs in patients with cardiovascular risk such as hypercholesterolemia and type 2 diabetes mellitus ( T2DM ) .
METHODS	Additional in vitro study was conducted to clarify the direct effects of both statins on EPCs from the patients .
RESULTS	A total of 26 patients ( 19 with T2DM ) completed the study .
RESULTS	While the lipid-lowering effects were similar in both treatments , the counts of circulating CD34 + KDR+EPC s were significantly increased ( from 0.0210.015 to 0.0540.044 % of gated mononuclear cells , P < 0.05 ) only by pitavastatin treatment .
RESULTS	Besides , plasma asymmetric dimethylarginine level was reduced ( from 0.680.10 to 0.530.12 mol/L , P < 0.05 ) by atorvastatin , and plasma vascular endothelial growth factor ( VEGF ) level was increased ( from 74.3332.26 to 98.6546.64 pg/mL , P < 0.05 ) by pitavastatin .
RESULTS	In the in vitro study , while both statins increased endothelial nitric oxide synthase ( eNOS ) expression , only pitavastatin increased the phosphorylation of eNOS in EPCs .
RESULTS	Pitavastatin but not atorvastatin ameliorated the adhesion ability of early EPCs and the migration and tube formation capacities of late EPCs .
CONCLUSIONS	While both statins similarly reduced plasma lipids , only pitavastatin increased plasma VEGF level and circulating EPCs in high-risk patients , which is probably related to the differential pleiotropic effects of different statins .
BACKGROUND	This trial is registered at ClinicalTrials.gov , NCT01386853 .

###25265102
BACKGROUND	Heart rate variability ( HRV ) has been used as a measure of stress and mental strain in surgeons .
BACKGROUND	Low HRV has been associated with death and increased risk of cardiac events in the general population .
BACKGROUND	The aim of this study was to clarify the effect of a 17-hour night shift on surgeons ' HRV .
METHODS	Surgeons were monitored prospectively with an ambulatory electrocardiography device for 48 consecutive hours , beginning on a precall day and continuing through an on-call ( 17-h shift ) day .
METHODS	We measured HRV by frequency domain parameters .
RESULTS	We included 29 surgeons in our analysis .
RESULTS	The median pulse rate was decreased precall ( median 64 , interquartile range [ IQR ] 56-70 beats per minute [ bpm ] ) compared with on call ( median 81 , IQR 70-91 bpm , p < 0.001 ) .
RESULTS	Increased high-frequency ( HF ) activity was found precall ( median 199 , IQR 75-365 ms2 ) compared with on call ( median 99 , IQR 48-177 ms2 , p < 0.001 ) .
RESULTS	The low-frequency : high-frequency ( LF : HF ) ratio was lower precall ( median 2.7 , IQR 1.9-3 .9 ) than on call ( median 4.9 , IQR 3.7-6 .5 , p < 0.001 ) .
RESULTS	We found no correlation between the LF : HF ratio and performance in laparoscopic simulation .
CONCLUSIONS	Surgeons working night shifts had a significant decrease in HRV and a significant increase in pulse rate , representing sympathetic dominance in the autonomic nervous system .
BACKGROUND	NCT01623674 ( www.clinicaltrials.gov ) .

###25297337
BACKGROUND	Adenosine is the first-line medication in patients with paroxysmal supraventricular tachycardia .
BACKGROUND	Because it is cleared so rapidly from the circulation , recurrence of paroxysmal supraventricular tachycardia after initial successful conversion may occur .
OBJECTIVE	This study was conducted to evaluate the role of oral verapamil administration to control early recurrences of paroxysmal supraventricular tachycardia after adenosine infusion .
METHODS	Patients with acute paroxysmal supraventricular tachycardia and no contraindications for adenosine or verapamil treatment were included in study .
METHODS	All patients received an adenosine protocol ( 6 mg rapid bolus intravenous injection followed by two repeated doses of 12 mg if necessary ) .
METHODS	Patients in the adenosine-only group did not received any other medications but patients in the adenosine/verapamil group received 40 mg verapamil orally immediately after converting the rhythm to sinus rhythm .
METHODS	All patients were followed up for 6 h in the acute care area of the emergency department under continuous cardiac monitoring .
RESULTS	A total of 113 patients were assessed for eligibility and 92 patients were randomized into two groups ( adenosine only versus adenosine/verapamil ) .
RESULTS	There was no statistically significant difference in paroxysmal supraventricular tachycardia recurrence rate between the two groups in the first 30 min after treatment .
RESULTS	Recurrence rate was statistically significantly lower in the adenosine/verapamil group than in the adenosine-only group between 30 and 120 min after treatment and thereafter .
RESULTS	Two patients in the adenosine-only group experienced flushing and one patient in the adenosine/verapamil group experienced decreased systolic blood pressure .
CONCLUSIONS	Oral verapamil can decrease paroxysmal supraventricular tachycardia recurrence after successful control with intravenous adenosine .

###25242806
BACKGROUND	In Parkinson 's Disease ( PD ) , cognitive dysfunctions which can reduce patients ' quality of life occur frequently .
BACKGROUND	Data on non-pharmacological intervention effects on cognitive functions in patients with PD are rare .
BACKGROUND	The aim of this study was to examine the effects of different cognitive group trainings ( structured vs. unstructured ) on cognition , depression , and quality of life in non-demented PD patients .
METHODS	In this randomized controlled trial , 65 non-demented patients with PD according to UK Brain Bank criteria ( Hoehn & Yahr I-III ) were allocated to one of two cognitive multi-component treatments ( `` NEUROvitalis '' , a structured training , or the unstructured training `` Mentally fit '' with randomly assembled cognitive tasks , each including 12 group-sessions 90min over 6 weeks ) or a waiting list control group ( CG ) .
METHODS	A neuropsychological test battery was performed before and after the training .
RESULTS	Compared to the CG , patients from the `` NEUROvitalis '' group improved in short-term memory ( word list learning `` Memo '' : p < .01 ) and working memory ( digit span reverse from `` DemTect '' : p < .05 ) , whereas depression scores where reduced in the `` Mentally fit '' group ( Beck Depression Inventory-II : p < .05 ) .
RESULTS	The `` NEUROvitalis '' group improved significantly more in working memory than the `` Mentally fit '' group ( DemTect : p < .05 ) .
CONCLUSIONS	Cognitive and affective functions can be improved by cognitive trainings in PD patients .
CONCLUSIONS	Specific effects ( e.g. on memory and working memory versus depression ) seem to be dependent on the type of training .
CONCLUSIONS	Further research is needed to define long-term effects and the efficacy in PD patients with different extent of cognitive and neuropsychiatric symptoms .

###25246338
BACKGROUND	Stem cell therapy ( SCT ) is used for immunosuppression minimization in renal transplantation ( RT ) .
BACKGROUND	We carried out a prospective study to evaluate the benefits of co-infusion of donor adipose-derived mesenchymal stem cells ( AD-MSC ) + hematopoietic stem cells ( HSC ) in living donor RT ( LDRT ) under non-myeloablative conditioning .
METHODS	In a demographically balanced three-armed LDRT trial with 95 patients in each arm , group-1 received portal co-infusion of AD-MSC + HSC , group-2 received HSC and group-3 received no SCT .
METHODS	Lymphoid irradiation and anti-thyroglobulin were used for conditioning .
RESULTS	SCT was safe .
RESULTS	At 1 and 5 years post-transplant , patient survival was 100 % and 94.7 % in group-1 , 100 % and 95.7 % in group-2 , and 94.7 % and 84 % in group-3 , death-censored graft survival was 100 % and 94.6 % in group-1 , 100 % and 91.3 % in group-2 , and 98.9 % and 94.4 % in group-3 with mean serum creatinine ( mg/dL ) of 1.38 and 1.39 in group-1 , 1.48 and 1.51 in group-2 , and 1.29 and 1.42 and in group-3 .
RESULTS	Rejection episodes and immunosuppression requirement were lesser in SCT groups versus controls with best results noted in group-1 .
CONCLUSIONS	Coinfusion of donor AD-MSC + HSC in portal circulation pre-transplant under non-myeloablative conditioning is safe and effective for immunosuppression minimization in LDRT .

###24342143
OBJECTIVE	We examined the effects of doxazosin , finasteride and combined therapy in men with lower urinary tract symptoms associated with benign prostatic hyperplasia on sexual function , as assessed by the Brief Male Sexual Function Inventory during 4 years .
METHODS	The MTOPS ( Medical Therapy of Prostatic Symptoms ) study was a multicenter , randomized , double-blind , placebo controlled clinical trial with a primary outcome of time to benign prostatic hyperplasia progression .
METHODS	Change in sexual function was a secondary outcome .
METHODS	We analyzed the records of2 ,783 men enrolled in the study who completed the inventory at baseline and atleast once during followup .
RESULTS	In men enrolled in MTOPS sexual function decreased with time .
RESULTS	Men assigned to finasteride and combined therapy experienced overall statistically significant but slight worsening of ejaculatory function compared with men on placebo .
RESULTS	Men assigned to combined therapy also experienced significant worsening in erectile function and sexual problem assessment .
RESULTS	There was no significant difference in changes in any inventory domain in men assigned to doxazosin alone compared to placebo .
CONCLUSIONS	This study significantly extends understanding of the effects of long-term treatment with these drugs on sexual function in men with lower urinary tract symptoms associated with benign prostatic hyperplasia .
CONCLUSIONS	Treatment with finasteride or combined therapy was associated with worsening sexual function while treatment with doxazosin alone was associated with minimal negative impact , if any .
CONCLUSIONS	Physicians should discuss with their patients the possible long-term effects of these drugs for lower urinary tract symptoms associated with benign prostatic hyperplasia on sexual function .

###25211216
BACKGROUND	We developed a unique remote monitoring and control diabetes management system ( MDRS ) supporting the use of an artificial pancreas ( AP ) at home .
BACKGROUND	In this study , we aimed at assessing the efficacy and safety of the MDRS and its ability to prevent or shorten nocturnal hypoglycemia episodes without the use of an AP , as well as evaluating parental attitudes toward the use of such a system in the future .
METHODS	This was a prospective , case control , randomized study .
METHODS	Eighteen patients treated nightly over a 2-week period by the MDRS were compared with 19 patients treated with sensor-augmented pump ( SAP ) therapy .
METHODS	We analyzed the performance of the MDRS , the number and duration of hypo - or hyperglycemia episodes , and the efficacy of the MDRS in detecting them .
METHODS	Parents of the study participants completed the hypoglycemia fear survey , attitude , and satisfaction questionnaires .
RESULTS	The MDRS allows continuous monitoring of the patients using it .
RESULTS	Without the use of an AP , the MDRS did not significantly prevent nocturnal hypoglycemia episodes .
RESULTS	The patients and their parents found the system reliable and user-friendly .
RESULTS	The overall impression of the MDRS users was favorable , with a keen interest of the patients and their caregivers to use such a system in the future .
CONCLUSIONS	The MDRS is reliable and safe remote monitoring system for AP at-home systems .
CONCLUSIONS	Remote monitoring of type 1 diabetes patients treated with SAP therapy is a promising and feasible task that is highly anticipated by patients and their caregivers .

###25444633
OBJECTIVE	To assess the efficacy of animated biofeedback and pelvic floor muscle ( PFM ) exercise in managing children with non-neuropathic underactive bladder ( UB ) .
METHODS	A total of 50 children with UB without underlying neuropathic disease , aged 5-16 years , were included in this study .
METHODS	They were randomly divided into 2 equal treatment groups comprising standard urotherapy ( hydration , scheduled voiding , toilet training , and diet ) with ( group A ) or without ( group B ) animated biofeedback and PFM exercise .
METHODS	The follow-up period for each participant was 1 year .
METHODS	A complete voiding and bowel habit diary was recorded by participants ' parents before and after 2 evaluations .
METHODS	In addition , uroflowmetry with electromyography and bladder ultrasound were performed before , 6 months , and 1 year after treatment .
METHODS	Results were compared between the 2 cohorts .
RESULTS	Mean number of voiding episodes was significantly increased in group A after biofeedback therapy compared with group B with only standard urotherapy ( 6.6 1.6 vs 4.5 1 times a day ; P < .000 ) .
RESULTS	Urinary tract infection did not relapse in 9 of 11 ( 81 % ) and 8 of 15 ( 38 % ) patients in groups A and B , respectively ( P < .02 ) .
RESULTS	Postvoid residual volume and voiding time decreased considerably , whereas maximum urine flow increased significantly in group A compared with group B ( 17.2 4.7 vs 12.9 4.6 mL/s ; P < .01 ) .
CONCLUSIONS	Combination of animated biofeedback and PFM exercise effectively improves sensation of bladder fullness and contractility in children with UB due to voiding dysfunction .

###25998003
OBJECTIVE	To compare retention rates of Super Flex ( Eagle Vision , Memphis , Tennessee , USA ; Softplug-Oasis Medical Inc , Glendora , California , USA ) vs Parasol ( Odyssey Medical , Memphis , Tennessee , USA ; Beaver Visitec International , Waltham , Massachusetts , USA ) punctal plugs .
METHODS	Randomized , double-masked , interventional controlled clinical trial .
METHODS	Institutional study at Hotel Dieu Hospital ( Queen 's University ) of 50 eyes , from patients with moderate to severe dry eye .
METHODS	Each eye from eligible patients was separately randomized to receive Super Flex or Parasol punctal plugs .
METHODS	The main outcome measure was plug retention at 6 months .
METHODS	Secondary outcome measures included objective tests of Schirmer I ( mm ) , tear meniscus height ( mm ) , tear break-up time ( s ) , inferior fluorescein corneal staining ( National Eye Institute [ NEI ] scale ) , and average lissamine green conjunctival staining ( NEI scale ) .
RESULTS	Punctal plug retention was significantly different at 6 months ( P = .011 ) .
RESULTS	Sixty-eight percent of Parasol plugs were retained compared to 32 % of Super Flex plugs .
RESULTS	Parasol plugs required less frequent artificial tear use at 6 months ( P = .024 ) .
RESULTS	There was a statistically significant improvement in all secondary outcome measures ( Schirmer , tear meniscus height , tear break-up time , fluorescein corneal staining ) at 6 months within plug groups except conjunctival staining .
RESULTS	There were no additional significant differences between groups and no plug complications reported .
CONCLUSIONS	Punctal plugs improve symptoms of moderate to severe dry eye ; however , retention rates differ significantly .
CONCLUSIONS	These data will allow us to guide patient decision making for the safe and effective treatment of punctal plugs for moderate to severe dry eye .

###24962502
OBJECTIVE	Little is known about adolescent relationship abuse ( ARA ) and related sexual and reproductive health among females who either identify as lesbian or bisexual or engage in sexual behavior with female partners ( i.e. , sexual minority girls [ SMGs ] ) .
METHODS	Baseline data were collected from 564 sexually active girls ages 14-19 years seeking care at eight California school-based health centers participating in a randomized controlled trial .
METHODS	Associations between ARA , sexual minority status and study outcomes ( vaginal , oral , and anal sex , number and age of sex partners , contraceptive nonuse , reproductive coercion , sexually transmitted infection [ STI ] and pregnancy testing ) were assessed via logistic regression models for clustered survey data .
RESULTS	SMGs comprised 23 % ( n = 130 ) of the sample .
RESULTS	Controlling for exposure to ARA , SMGs were less likely to report recent vaginal sex ( adjusted odds ratio [ AOR ] , .51 ; 95 % confidence interval [ CI ] , .35 -.75 ) and more likely to report recent oral sex ( AOR , 2.01 ; 95 % CI , 1.38-2 .92 ) and anal sex ( AOR , 1.76 ; 95 % CI , 1.26-2 .46 ) compared with heterosexual girls .
RESULTS	Heterosexual girls with ARA exposure ( AOR , 2.85 ; 95 % CI , 1.07-7 .59 ) and SMGs without ARA exposure ( AOR , 3.01 ; 95 % CI , 2.01-4 .50 ) were more likely than nonabused heterosexual girls be seeking care for STI testing or treatment than heterosexual girls without recent victimization .
CONCLUSIONS	Findings suggest the need for attention to STI risk among all girls , but SMGs in particular .
CONCLUSIONS	Clinicians should be trained to assess youth for sexual contacts and sexual identity and counsel all youth on healthy relationships , consensual sex , and safer sex practices relevant to their sexual experiences .

###24943129
BACKGROUND	Vancomycin is the standard first-line treatment for methicillin-resistant Staphylococcus aureus bacteremia .
BACKGROUND	However , recent consensus guidelines recommend that clinicians consider using alternative agents such as daptomycin when the vancomycin minimum inhibitory concentration is greater than 1 ug/ml .
BACKGROUND	To date however , there have been no head-to-head randomized trials comparing the safety and efficacy of daptomycin and vancomycin in the treatment of such infections .
BACKGROUND	The primary aim of our study is to compare the efficacy of daptomycin versus vancomycin in the treatment of bloodstream infections due to methicillin-resistant Staphylococcus aureus isolates with high vancomycin minimum inhibitory concentrations ( greater than or equal to 1.5 ug/ml ) in terms of reducing all-cause 60-day mortality .
METHODS	The study is designed as a multicenter prospective open label phase IIB pilot randomized controlled trial .
METHODS	Eligible participants will be inpatients over 21-years-old with a positive blood culture for methicillin-resistant Staphylococcus aureus with vancomycin minimum inhibitory concentration of greater than or equal to 1.5 ug/ml .
METHODS	Randomization into intervention or active control arms will be performed with a 1:1 allocation ratio .
METHODS	We aim to recruit 50 participants over a period of two years .
METHODS	Participants randomized to the active control arm will receive vancomycin dose-while those randomized to the intervention arm will receive daptomycin .
METHODS	Participants will receive a minimum of 14 days study treatment.The primary analysis will be conducted on the intention-to-treat principle .
METHODS	The Fisher 's exact test will be used to compare the 60-day mortality rate from index blood cultures ( primary endpoint ) between the two treatment arms , and the exact two-sided 95 % confidence interval will be calculated using the Clopper and Pearson method .
METHODS	Primary analysis will be conducted using a two sided alpha of 0.05 .
CONCLUSIONS	If results from this pilot study suggest that daptomycin shows significant efficacy in the treatment of bloodstream infections due to methicillin-resistant Staphylococcus aureus isolates with high vancomycin minimum inhibitory concentrations , we aim to proceed with a larger scale confirmatory study .
CONCLUSIONS	This would help guide clinicians and inform practice guidelines on the optimal treatment for such infections .
BACKGROUND	The trial is listed on clinicaltrials.gov ( NCT01975662 , date of registration : 29 October 2013 ) .

###24582471
BACKGROUND	Amyotrophic lateral sclerosis is a fatal neurodegenerative disease with few therapeutic options .
BACKGROUND	Mild obesity is associated with greater survival in patients with the disease , and calorie-dense diets increased survival in a mouse model .
BACKGROUND	We aimed to assess the safety and tolerability of two hypercaloric diets in patients with amyotrophic lateral sclerosis receiving enteral nutrition .
METHODS	In this double-blind , placebo-controlled , randomised phase 2 clinical trial , we enrolled adults with amyotrophic lateral sclerosis from participating centres in the USA .
METHODS	Eligible participants were aged 18 years or older with no history of diabetes or liver or cardiovascular disease , and who were already receiving percutaneous enteral nutrition .
METHODS	We randomly assigned participants ( 1:1:1 ) using a computer-generated list of random numbers to one of three dietary interventions : replacement calories using an isocaloric tube-fed diet ( control ) , a high-carbohydrate hypercaloric tube-fed diet ( HC/HC ) , or a high-fat hypercaloric tube-fed diet ( HF/HC ) .
METHODS	Participants received the intervention diets for 4 months and were followed up for 5 months .
METHODS	The primary outcomes were safety and tolerability , analysed in all patients who began their study diet .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00983983 .
RESULTS	Between Dec 14 , 2009 , and Nov 2 , 2012 , we enrolled 24 participants , of whom 20 started their study diet ( six in the control group , eight in the HC/HC group , and six in the HF/HC group ) .
RESULTS	One patient in the control group , one in the HC/HC group , and two in the HF/HC group withdrew consent before receiving the intervention .
RESULTS	Participants who received the HC/HC diet had a smaller total number of adverse events than did those in the other groups ( 23 in the HC/HC group vs 42 in the control group vs 48 in the HF/HC group ; overall , p = 0.06 ; HC/HC vs control , p = 0.06 ) and significantly fewer serious adverse events than did those on the control diet ( none vs nine ; p = 0.0005 ) .
RESULTS	Fewer patients in the HC/HC group discontinued their study diet due to adverse events ( none [ 0 % ] of eight in the HC/HC group vs three [ 50 % ] of six in the control group ) .
RESULTS	During the 5 month follow-up , no deaths occurred in the nine patients assigned to the HC/HC diet compared with three deaths ( 43 % ) in the seven patients assigned to the control diet ( log-rank p = 0.03 ) .
RESULTS	Adverse events , tolerability , deaths , and disease progression did not differ significantly between the HF/HC group and the control group .
CONCLUSIONS	Our results provide preliminary evidence that hypercaloric enteral nutrition is safe and tolerable in patients with amyotrophic lateral sclerosis , and support the study of nutritional interventions in larger randomised controlled trials at earlier stages of the disease .
BACKGROUND	Muscular Dystrophy Association , National Center for Research Resources , National Institutes of Health , and Harvard NeuroDiscovery Center .

###24858737
BACKGROUND	Various laser treatments are currently available for melasma but their use remains challenging because of potential side effects .
OBJECTIVE	The aim of this randomized controlled study was to compare the efficacy and safety of low-fluence Q-switch 1,064 nm Nd : YAG and low-power fractional CO2 laser using a split-face design .
METHODS	A total of 40 female patients with symmetric melasma were enrolled to the study and each side of their face was randomly allocated to either low-fluence Q-switch 1,064 nm Nd : YAG or low-power fractional CO2 laser .
METHODS	They were treated every 3 weeks for five consecutive sessions and followed for 2 months after the last treatment session .
METHODS	Response to treatment was assessed using the Melanin Index ( MI ) score , modified Melasma Area and Severity Index ( mMASI ) score , and a subjective self-assessment method .
RESULTS	At the 2-month follow-up visit , both sides of the face had statistically significant reductions in the MI and mMASI scores compared with the first visit ( p < 0.001 ) .
RESULTS	The differences between the mean MI and mMASI scores at baseline and at 2-month follow-up were compared between the two treatments and results showed that the reduction of MI and mMASI score in the fractional CO2 laser-treated side was significantly more than on the Q-switch 1,064 nm Nd : YAG laser-treated side ( p < 0.001 ) .
RESULTS	There were no significant adverse effects with either of the laser treatments .
CONCLUSIONS	The present study shows that low-power fractional CO2 laser is safe and effective and can be considered as a valuable approach in the treatment of melasma .

###24857002
OBJECTIVE	To observe the clinical therapeutic effect of OM-85 BV ( OM-85 Broncho-Vaxom ) in children with asthma and recurrent respiratory tract infection , and the effect of OM-85 BV on human - defensins 1 ( hBD-1 ) and immunoglobulin levels .
METHODS	Sixty-two children with asthma and recurrent respiratory infection treated between 2011 January and December were divided into two groups by the randomized , double blind method : a treatment group and a control group .
METHODS	With inhaling corticosteroids , the treatment group was given OM-85 BV , and the control group was given a placebo .
METHODS	Clinical curative effects and adverse reactions were observed .
METHODS	Serum levels of hBD-1 , IgA , IgG , IgM and urea and alanine aminotransferase ( ALT ) were measured before treatment and 6 months and 12 months after treatment .
RESULTS	Compared with the control group and before treatment , the frequency of respiratory tract infection was reduced in the treatment group 6 months and 12 months after treatment ( P < 0.05 ) , and serum levels of hBD-1 , IgA and IgG in the treatment group increased significantly ( P < 0.05 ) .
RESULTS	There was no significant difference in serum levels of urea , ALT and IgM between the control and treatment groups ( P > 0.05 ) .
RESULTS	Mild adverse reactions occurred in 3 cases in the two groups , 2 cases of abdominal pain and 1 cases of constipation .
CONCLUSIONS	OM-85 BV can improve serum levels of hBD-1 , IgA and IgG , reduce the occurrence of acute respiratory tract infection and cause mild adverse reactions , suggesting its satisfactory therapeutic effect and safety in the treatment of asthma combined with recurrent respiratory tract infection in children .

###26093979
BACKGROUND	Supplementary immunisation activities with oral poliovirus vaccines ( OPVs ) are usually separated by 4 week intervals ; however , shorter intervals have been used in security-compromised areas and for rapid outbreak responses .
BACKGROUND	We assessed the immunogenicity of monovalent type-1 oral poliovirus vaccine ( mOPV1 ) given at shorter than usual intervals in Karachi , Pakistan .
METHODS	This was a multicentre , randomised , controlled , four-arm , open-label , non-inferiority trial done at five primary health-care centres in low-income communities in and around Karachi , Pakistan .
METHODS	Eligible participants were healthy newborn babies with a birthweight of at least 25 kg , for whom informed consent was provided by their parent or guardian , and lived less than 30 km from the study clinic .
METHODS	After receiving a birth dose of trivalent OPV , we enrolled and randomly assigned newborn babies ( 1:1:1:1 ) to receive two doses of mOPV1 with an interval of 1 week ( mOPV1-1 week ) , 2 weeks ( mOPV1-2 weeks ) , or 4 weeks ( mOPV1-4 weeks ) between doses , or two doses of bivalent OPV ( bOPV ) with an interval of 4 weeks between doses ( bOPV-4 weeks ) .
METHODS	We gave the first study dose of OPV at age 6 weeks .
METHODS	We did the randomisation with a centrally generated , computerised allocation sequence with blocks of 16 ; participants ' families and study physicians could not feasibly be masked to the allocations .
METHODS	Trial participants were excluded from local supplementary immunisation activities during the study period .
METHODS	The primary outcome was non-inferiority ( within a 20 % margin ) between groups in seroconversion to type-1 poliovirus .
METHODS	The primary and safety analyses were done in the per-protocol population of infants who received all three doses of vaccine .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01586572 , and is closed to new participants .
RESULTS	Between March 1 , 2012 , and May 31 , 2013 , we enrolled 1009 newborn babies , and randomly assigned 829 ( 82 % ) to treatment .
RESULTS	554 ( 67 % ) of the 829 babies were included in the per-protocol analysis .
RESULTS	Proportions of seroconversion to type-1 poliovirus were 107/135 ( 79 % , 95 % CI 724-861 ) with mOPV1-1 week , 108/135 ( 80 % , 732-868 ) with mOPV1-2 weeks , 129/148 ( 87 % , 809-920 ) with mOPV1-4 weeks , and 107/136 ( 79 % , 718-856 ) with bOPV-4 weeks .
RESULTS	Non-inferiority was shown between groups and no significant differences were noted .
RESULTS	Ten participants died during the trial .
RESULTS	Seven of these deaths occurred during the lead-in period before randomisation ( two from diarrhoea , five from unknown causes ) .
RESULTS	Three infants died from sepsis after random assignment .
RESULTS	No deaths were attributed to the procedures or vaccines .
RESULTS	Additionally , we noted no events of vaccine-associated paralysis .
CONCLUSIONS	We identified no significant differences in responses to mOPV1 given with shorter intervals between doses than with the standard 4 week intervals .
CONCLUSIONS	The short-interval strategy could be particularly beneficial when temporary windows of opportunity for safe access can be granted in areas of conflict -- eg , during cease-fire periods .
CONCLUSIONS	In such situations , we recommend shortening the interval between OPV doses to 7 days .
BACKGROUND	World Health Organization .

###25512268
OBJECTIVE	To evaluate the cardioprotection of remote ischemic postconditioning ( RIPostC ) in patients with acute ST-segment elevation myocardial infarction ( STEMI ) who underwent primary percutaneous coronary intervention ( PCI ) .
METHODS	Forty-six STEMI patients undergoing primary PCI at Peking University Third Hospital from January to April 2014 were randomized to RIPostC group ( n = 23 ) and control group ( n = 23 ) .
METHODS	The RIPostC protocol was started within 1 min after reflow by thrombus aspiration or balloon inflation and consisted of 3 cycles of 5 min/5 min ischemia/reperfusion by cuff inflation/deflation of the lower left limb .
METHODS	The enzymatic infarct size , rate of complete ST segment resolution , corrected thrombolysis in myocardial infarction ( TIMI ) frame count ( CTFC ) in infarct-related artery ( IRA ) and plasma levels of malondialdehyde ( MDA ) , endothelin-1 ( ET-1 ) , tumor necrosis factor ( TNF ) of the two groups were compared .
RESULTS	There was no significant difference in enzymatic infarct size between the two groups ( P > 0.05 ) .
RESULTS	The rate of complete ST-segment resolution was significantly higher in RIPostC group than in control group ( 60.9 % vs. 30.4 % , P = 0.04 ) .
RESULTS	There was a trend toward lower CTFC in RIPostC group than that in control group , but the difference was not statistically significant ( 28 11 vs. 33 11 , P = 0.10 ) .
RESULTS	However , in the subgroup of anterior wall myocardial infarction CTFC in RIPostC group was significantly lower , compared with control group ( 259 vs. 3910 , P = 0.01 ) .
RESULTS	There were lower plasma levels of MDA,ET-1 , TNF in RIPostC group than in control group at different time points after primary PCI ( P < 0.05 ) .
CONCLUSIONS	In STEMI patients undergoing primary PCI , RIPostC may improve myocardial perfusion and attenuate ischemia reperfusion injury with the underlying mechanisms involving reduction of oxidative stress , protection of endothelial function and inhibition of inflammatory response .

###24452943
OBJECTIVE	Long-term therapy of hypertension may influence mineral status in patients .
OBJECTIVE	However , drug-micronutrient interactions are largely unexplored in practice .
OBJECTIVE	This study intended to evaluate the effect of hypotensive monotherapy on iron , zinc , and copper levels , as well as on selected biochemical parameters , in newly diagnosed patients with hypertension , and to assess the influence of diet with optimal mineral levels on the mineral balance in these subjects .
METHODS	Forty-five patients , aged 18-65 years with diagnosed essential hypertension , beginning monotherapy treatment with diuretics , calcium antagonists , angiotensin-converting enzyme inhibitors , and - blockers , were employed .
METHODS	Over three months , the patients underwent monotherapy ( stage II ) .
METHODS	Next , patients were randomly divided into a diet group ( of 27 subjects ) and a control group ( of 18 subjects ) .
METHODS	In this stage , which lasted one month , patients were given the same drug but also followed an optimal mineral-content diet ( for the diet group ) , or else continued drug use without any change in diet ( for control group ) ( stage III ) .
METHODS	Lipids , glucose , ceruloplasmin , and ferritin -- along with superoxide dismutase and catalase activities -- were assayed in serum .
METHODS	Iron , zinc , and copper concentrations in serum , erythrocytes , and urine were determined using flame atomic absorption spectrometry .
METHODS	Blood pressure was measured .
METHODS	Diet intake was monitored at each stage .
RESULTS	It was found that the zinc level in serum significantly decreased following treatment , and that the use of the optimal-mineral diet during antihypertensive treatment markedly increased zinc serum concentration .
RESULTS	After treatment , a significant increase in zinc excretion in the urine was observed .
RESULTS	Glucose levels in the serum of patients in stage II were significantly higher than in the baseline .
RESULTS	In patients in the diet group , glucose levels markedly decreased .
RESULTS	Moreover , a negative correlation was found between serum glucose and zinc levels in patients .
CONCLUSIONS	Antihypertensive treatments should include monitoring of mineral status .
CONCLUSIONS	It seems that the zinc balance of patients on long-term therapy with hypotensive drugs may benefit from an optimal-mineral diet .

###25270782
BACKGROUND	Aim of the present study was to compare the effects of highly branched cyclic dextrin ( HBCD ) drink with a glucose-based control drink on immunoendocrine responses to endurance exercise .
METHODS	Using a randomized , double-blind placebo-controlled cross-over design , seven male triathletes participated in two duathlon races separated by one month , consisting of 5 km of running , 40 km of cycling and 5 km of running .
METHODS	In the first race , four athletes consumed the HBCD-based drink and three athletes consumed the glucose-based drink .
METHODS	In the second race , three athletes consumed the HBCD-based drink and four athletes consumed the glucose-based drink .
METHODS	We collected blood and urine samples before and after the races to analyze leukocyte count and concentrations of hormones and cytokines .
RESULTS	Lymphocyte and neutrophil counts increased significantly after exercise in both trials ( P < 0.05 ) , but were not significantly different between the trials .
RESULTS	Plasma noradrenalin concentration increased significantly ( P < 0.05 ) during exercise in the glucose trial , but not in the HBCD trial .
RESULTS	Plasma concentrations of interleukin ( IL ) -8 and IL-10 increased significantly during exercise in both trials ( P < 0.05 ) but were not significantly different between the trials .
RESULTS	Post-race urinary IL-8 , IL-10 and IL-12p40 concentrations were significantly lower in the HBCD trial compared with the glucose trial ( P < 0.05 ) , although the plasma concentrations of these cytokines were not significantly different between both trials .
CONCLUSIONS	These results suggest that the HBCD-based drink may attenuate the stress hormone response , and reduce the urinary cytokine levels following exhaustive exercise .

###24878521
BACKGROUND	To promote well-being and health behaviors among adolescents , 2 interventions were implemented at 12 secondary schools .
BACKGROUND	Adolescents in the E-health4Uth group received Web-based tailored messages focused on their health behaviors and well-being .
BACKGROUND	Adolescents in the E-health4Uth and consultation group received the same tailored messages , but were subsequently referred to a school nurse for a consultation if they were at risk of mental health problems .
OBJECTIVE	This study evaluated the effect of E-health4Uth and E-health4Uth and consultation on well-being ( ie , mental health status and health-related quality of life ) and health behaviors ( ie , alcohol and drug use , smoking , safe sex ) .
METHODS	A cluster randomized controlled trial was conducted among third - and fourth-year secondary school students ( mean age 15.9 , SD 0.69 ) .
METHODS	School classes ( clusters ) were randomly assigned to ( 1 ) E-health4Uth group , ( 2 ) E-health4Uth and consultation group , or ( 3 ) control group ( ie , care as usual ) .
METHODS	Adolescents completed a questionnaire at baseline and at 4-month follow-up assessing alcohol consumption , smoking , drug use , condom use , mental health via the Strengths and Difficulties Questionnaire ( SDQ ) and the Youth Self Report ( YSR ; only measured at follow-up ) , and health-related quality of life .
METHODS	Multilevel logistic , ordinal , and linear regression analyses were used to reveal differences in health behavior and well-being between the intervention groups and the control group at follow-up .
METHODS	Subsequently , it was explored whether demographics moderated the effects .
RESULTS	Data from 1256 adolescents were analyzed .
RESULTS	Compared to the control intervention , the E-health4Uth intervention , as a standalone intervention , showed minor positive results in health-related quality of life ( B = 2.79 , 95 % CI 0.72-4 .87 ) and condom use during intercourse among adolescents of Dutch ethnicity ( OR 3.59 , 95 % CI 1.71-7 .55 ) not replicated in the E-health4Uth and consultation group .
RESULTS	The E-health4Uth and consultation intervention showed minor positive results in the mental health status of adolescents ( SDQ : B = -0.60 , 95 % CI -1.17 to -0.04 ) , but a negative effect on drug use among boys ( OR 0.36 , 95 % CI 0.13-0 .96 ) .
RESULTS	In the subgroup of adolescents who were at risk of mental health problems at baseline ( and referred for a consultation with the nurse ) , the E-health4Uth and consultation group showed minor to moderate positive results in mental health status ( SDQ : B = -1.79 , 95 % CI -3.35 to -0.22 ; YSR : B = -9.11 , 95 % CI -17.52 to -0.71 ) and health-related quality of life ( B = 7.81 , 95 % CI 2.41-13 .21 ) at follow-up compared to adolescents in the control group who were at risk of mental health problems at baseline .
CONCLUSIONS	Findings from this study support the use of the E-health4Uth and consultation intervention in promoting the well-being of adolescents at risk of mental health problems .
CONCLUSIONS	Future research is needed to further evaluate the effects of the consultation as a standalone intervention , and the dual approach of further tailored eHealth messages and a consultation .
BACKGROUND	Nederlands Trial Register : NTR 3596 ; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3596 ( Archived by WebCite at http://www.webcitation.org/6PmgrPOuv ) .

###25865433
OBJECTIVE	Examine psychological and behavioral predictors of 3-year weight loss maintenance in women .
METHODS	Participants were 154 women in a 1-year randomized controlled trial on weight management with a 2-year follow-up .
METHODS	Signal detection analyses identified behavioral and psychological variables that best predicted 5 % and 10 % weight loss at 3 years .
RESULTS	Women with better body image were more likely to have lost 5 % weight at 3 years ( P < 0.001 ) .
RESULTS	Exercise intrinsic motivation had a partial compensatory effect , in that women with poor body image but higher motivation were more likely to maintain weight loss than women with poor body image and lower motivation ( P < 0.001 ) .
RESULTS	Women with high exercise autonomous motivation were three times more likely to have lost 10 % weight than were those with lower autonomous motivation ( P < 0.001 ) .
RESULTS	Among women with lower autonomous motivation , perceiving fewer exercise barriers was somewhat compensatory : these women were more likely to maintain weight loss than women with lower autonomy but more perceived barriers ( P < 0.01 ) .
CONCLUSIONS	In overweight women , improving body image and increasing autonomous and intrinsic motivation for exercise likely promotes clinically significant long-term weight loss maintenance .
CONCLUSIONS	Decreasing perceived exercise barriers is another promising intervention target .

###24460597
OBJECTIVE	The purpose of this study was to investigate the effectiveness of an orientated tour in reduction of children 's anxiety before elective surgeries .
OBJECTIVE	Anxiety is a common emotional reaction following surgical experience among children that can result in increasing postoperative pain , increasing analgesic use .
METHODS	The study was a blinded clinical trial ; 70 children were randomized into two groups ( intervention and control ) .
METHODS	All children received standard preoperative care , while those in the intervention group also received an orientated tour with their mother of the operation room the night before the surgery was carried out .
METHODS	The children 's anxiety was assessed by the `` Child Drawing : Hospital '' instrument and vital signs measured before and after intervention in both groups .
METHODS	Data were analyzed with SPSS ver .
METHODS	11.5 software .
RESULTS	Anxiety decreased in the intervention group following implementation of the orientated tour ( P = 0.024 ) .
RESULTS	Following the orientated tour in the intervention group , respiration rate ( P < 0.000 ) and blood pressure ( P < 0.001 systolic and diastolic ) were significantly reduced , while heart rate and body temperature were not significantly different to pre-intervention .
RESULTS	Comparison changes of vital signs following the orientated tour between the two groups was not significant .
CONCLUSIONS	Implementation of an orientated tour of the preoperative room can decrease anxiety levels in children before elective surgeries , but it has no clinical effect on vital signs .

###25738177
OBJECTIVE	To compare the outcome of cross-arch prostheses supported either by supershort ( 5 mm ) or long ( 11.5 mm ) implants , placed flapless and immediately restored with metal-resin screw-retained cross-arch prostheses .
METHODS	Thirty patients with edentulous ( or to be rendered edentulous ) mandibles and 30 with edentulous maxillas , who had sufficient bone to allow the placement of four and six implants respectively , which were at least 11.5 mm-long , were randomised according to a parallel group design into 2 equal groups , where they received either 5 mm or 11.5 mm-long implants at one centre .
METHODS	Implants with a diameter of 5 mm , were to be placed flapless with an insertion torque of at least 50 Ncm .
METHODS	Mandibles received four implants between the mental foramina .
METHODS	Implants were to be immediately loaded with metal-resin-definitive prostheses on the same day of implant placement .
METHODS	Patients were followed up to 1 year after loading and the outcome measures were : prosthesis and implant failures , complications , and peri-implant marginal bone level changes .
RESULTS	No patients dropped-out .
RESULTS	Two prostheses were remade , one on short maxillary implants and one on long mandibular implants .
RESULTS	Two 5 mm maxillary implants which did not achieve 50 Ncm torque in soft bone of one patient , but were immediately loaded anyway , failed after 3 weeks compared to one mandibular 11.5 mm-long implant that failed after 60 days .
RESULTS	Two complications occurred in each group .
RESULTS	There were no statistically significant differences for prosthesis failures , implant failures and complications .
RESULTS	Patients with mandibular short implants lost on average 0.08 mm of peri-implant bone at 1 year and patients with long mandibular implants lost 0.51 mm .
RESULTS	Patients with short maxillary implants lost on average 0.15 mm of peri-implant bone at 1 year and patients with long maxillary implants lost 0.62 mm .
RESULTS	Short implants showed less bone loss when compared to long implants and the differences up to 1 year were statistically significant both in maxillae ( mean difference = 0.48 mm , 95 % CI 0.22 to 0.73 , P = 0.0011 ) and in mandibles ( mean difference = 0.44 mm , 95 % CI 0.21 to 0.66 , P = 0.0009 ) .
CONCLUSIONS	Flapless-placed 5 mm-long implants achieved similar results as 11.5 mm-long implants when supporting immediately loaded cross-arch prostheses both in maxillae and mandibles up to 1 year after loading .
CONCLUSIONS	These preliminary results must be confirmed by other trials , and 5 - to 10-year post-loading data is necessary before making reliable recommendations .

###24512647
BACKGROUND	Intense focused ultrasound ( IFUS ) has been used successfully for skin tightening .
OBJECTIVE	To investigate the efficacy of IFUS in treating enlarged pores and to evaluate changes in skin elasticity and sebum production following IFUS .
METHODS	Twenty-two subjects with enlarged pores were randomized to receive a single treatment with IFUS using 1.5-mm transducer on one side of the face , and 3.0-mm transducer on the other .
METHODS	OBJECTIVE clinical assessments were made by blinded photographic evaluation .
METHODS	Subjective satisfaction and adverse effects were evaluated .
METHODS	Measurements of elasticity and sebum were performed at baseline , 3 and 6 weeks post-treatment .
RESULTS	Physicians ' evaluation showed clinical pore improvements in 86 % and 91 % of the IFUS-treated sites using 1.5-mm and 3.0-mm transducer , respectively .
RESULTS	The mean improvement scores were 1.7 and 1.9 for 1.5-mm and 3.0-mm transducer , respectively , with no statistical differences .
RESULTS	Cutometer measurement demonstrated a significant improvement in skin elasticity .
RESULTS	Sebum level showed a reduction without statistical significance .
RESULTS	There was a positive correlation between improvement in elasticity and pore improvement grades .
RESULTS	All treatments were well tolerated without significant side effects .
CONCLUSIONS	IFUS using 1.5-mm or 3.0-mm transducer was safe and effective for reducing enlarged pores in Asian skin with an improvement in skin elasticity .

###24656693
OBJECTIVE	To evaluate a thermal pulsation treatment compared to a warming eyelid device for the management of meibomian gland dysfunction .
METHODS	Thirty patients were randomized into two groups : the first had a treatment with MeiboPatch ( ) on a daily basis for three months while the second had a single treatment with LipiFlow ( ) .
METHODS	The evaluation focused on a classical approach but also on a modern approach of the ocular surface ( interferometry lipid layer LipiView ( ) ) , analysis of the tear film by Oquas ( ) ( osmolarity by TearLab ( ) ) before treatment , then a month and three months later .
RESULTS	Both treatments proved to be effective with almost three times more functional meibomian glands at 3 months in the LipiFlow group and almost twice more in the MeiboPatch group ( P < 0.05 ) but the LipiFlow allows a more rapid improvement at the first month of treatment .
RESULTS	Functional scores and classic exploration of the ocular surface except the Schirmer test also undergo a significant improvement in both groups after three months of treatment .
CONCLUSIONS	The combination of heat applied to the inner eyelid surface , together with simultaneous expression of the glands , during a single 12-minute treatment shows to be highly effective in treating cases of meibomian gland disease .
CONCLUSIONS	Whilst results were excellent , and continued lid hygiene remains advised , the benefit of being able to simultaneous address potential compliance issues relating to ongoing treatment is significant .
CONCLUSIONS	The convenience of a single 12-minute treatment versus an ongoing daily heating regime was shown to be highly desirable and a welcome relief in our patients ' busy lifestyles .

###24472527
BACKGROUND	Type 1 diabetes demands a complicated disease self-management by child and parents .
BACKGROUND	The overwhelming task of combining every day parenting tasks with demands of taking care of a child with diabetes can have a profound impact on parents , often resulting in increased parenting stress .
BACKGROUND	Tailored disease information , easy accessible communication with healthcare professionals and peer support are found to support parents to adequately cope with the disease and the disease self-management in everyday life .
BACKGROUND	Internet can help facilitate these important factors in usual pediatric diabetes care .
BACKGROUND	Therefore , we will develop a web-based patient portal in addition to usual pediatric diabetes care and subsequently evaluate its efficacy and feasibility .
BACKGROUND	The web-based patient portal , called Sugarsquare , provides online disease information , and facilitates online parent-professional communication and online peer support .
BACKGROUND	We hypothesize that parenting stress in parents of a child with type 1 diabetes will decrease by using Sugarsquare and that Sugarsquare will be feasible in this population .
METHODS	We will test the hypotheses using a multicenter randomized controlled trial .
METHODS	Eligible participants are parents of a child with type 1 diabetes under the age of 13 .
METHODS	Parents are excluded when they have no access to the internet at home or limited comprehension of the Dutch language .
METHODS	Participants are recruited offline from seven clinics in the Netherlands .
METHODS	Participants are randomly allocated to an intervention and a control group .
METHODS	The intervention group will receive access to the intervention during the twelve-month study-period ; the control group will receive access in the last six months of the study-period .
METHODS	Self-reported parenting stress is the primary outcome in the present study .
METHODS	Data will be gathered at baseline ( T0 ) and at six ( T1 ) and twelve ( T2 ) months following baseline , using online questionnaires .
METHODS	User statistics will be gathered throughout the twelve-month study-period for feasibility .
CONCLUSIONS	Dependent on its feasibility and efficacy , the intervention will be implemented into usual pediatric diabetes care .
CONCLUSIONS	Strengths and limitations of the study are discussed .
BACKGROUND	NTR3643 ( Dutch Trial Register ) .

###24559757
OBJECTIVE	To investigate computer-assisted surgery ( CAS ) for dorsal insertion of percutaneous scaphoid screws and to compare operative time , accuracy , and fluoroscopy time with the traditional mini C-arm method .
OBJECTIVE	We hypothesized that CAS techniques would improve accuracy , reduce actual K-wire insertion time , and decrease fluoroscopy time .
METHODS	Ten fresh cadaveric upper limbs were randomized to either CAS or traditional dorsal percutaneous scaphoid screw placement by a single surgeon .
METHODS	Custom orthoses were applied to the CAS arms followed by intraoperative computed tomography ( CT ) scan and navigation calibration .
METHODS	Time was recorded for the portion of setup that required surgeon input , ideal guide wire placement , and fluoroscopy .
METHODS	Postoperative CT scans of the CAS arms were obtained to confirm accuracy .
METHODS	Two-tailed unpaired Student t test was used to analyze the outcome variables .
RESULTS	The CAS group required on average 4.8 0.8 minutes longer for setup .
RESULTS	The time forplacement of the guidewire in the ideal position was 4.6 1.5 minutes in the CAS group compared with 11.8 4.4 minutes in the control group .
RESULTS	Fluoroscopy time was 18 4 seconds for the CAS group and 114 38 seconds for the control group .
RESULTS	Postoperative CT scans demonstrated 1.5 0.6 mm maximum deviation from the planned ideal screw .
RESULTS	No significant differences were found in the accuracy between methods , the number of guidewire attempts , or the total surgical time .
CONCLUSIONS	Computer-assisted surgery navigation of dorsal percutaneous scaphoid screw placement takes on average 5 minutes longer to set up , but leads to significantly reduced guidewire placement time and no differences in overall procedural time .
CONCLUSIONS	This CAS method was as accurate as the traditional method and resulted in an approximate 6-fold reduction in fluoroscopy time .
CONCLUSIONS	This is an effective imaging alternative to the mini C-arm for scaphoid fixation using existing intraoperative CT scanners and navigation software .

###24962003
OBJECTIVE	Sodium drink is used as a countermeasure against body fluid loss .
OBJECTIVE	However , high concentrations of sodium may cause gastrointestinal upset ( e.g. , diarrhea ) .
OBJECTIVE	We sought to determine the sodium concentration that induces hypervolemia with a minimal risk of gastrointestinal disturbance .
METHODS	Eight healthy active males rested in a chair and ingested a given amount ( 16-17 ml kg body mass ( -1 ) ) of water ( W ) or solution containing 60 , 120 or 180 mmol l ( -1 ) Na ( + ) ( 60 , 120 and 180Na trials ) in 6 equal portions at 10 min intervals .
METHODS	To standardize their hydration status , subjects consumed the same meal and water 2 h before each trial .
METHODS	Drink trials were performed on separate days , and the order was randomized .
METHODS	The change in plasma volume ( PV ) from pre-drink status was estimated from the hemoglobin concentration and hematocrit every 30 min for 150 min after initiation of drinking .
RESULTS	Subjects began trials in a euhydrated state , as reflected by their plasma osmolality ( in mmol l ( -1 ) : W , 289.4 1.4 ; 60Na , 287.0 3.5 ; 120Na , 287.6 2.3 ; 180Na , 288.9 3.3 ) .
RESULTS	At 120 min , PV had not increased from the pre-drink value in the W ( -0.8 4.5 % ) or 60Na ( 2.4 4.9 % ) trials , but it increased to similar degrees in the 120Na ( 7.2 4.6 % ) and 180Na ( 9.4 6.6 % ) trials .
RESULTS	No diarrhea was reported in the W or 60Na trials , but it was reported in the 120Na ( n = 1 ) and 180Na ( n = 6 ) trials .
CONCLUSIONS	Beverages containing 120 mmol l ( -1 ) Na ( + ) induce hypervolemia with a minimum incidence of gastrointestinal problems .

###25791214
BACKGROUND	It is unclear whether radial compared with femoral access improves outcomes in unselected patients with acute coronary syndromes undergoing invasive management .
METHODS	We did a randomised , multicentre , superiority trial comparing transradial against transfemoral access in patients with acute coronary syndrome with or without ST-segment elevation myocardial infarction who were about to undergo coronary angiography and percutaneous coronary intervention .
METHODS	Patients were randomly allocated ( 1:1 ) to radial or femoral access with a web-based system .
METHODS	The randomisation sequence was computer generated , blocked , and stratified by use of ticagrelor or prasugrel , type of acute coronary syndrome ( ST-segment elevation myocardial infarction , troponin positive or negative , non-ST-segment elevation acute coronary syndrome ) , and anticipated use of immediate percutaneous coronary intervention .
METHODS	Outcome assessors were masked to treatment allocation .
METHODS	The 30-day coprimary outcomes were major adverse cardiovascular events , defined as death , myocardial infarction , or stroke , and net adverse clinical events , defined as major adverse cardiovascular events or Bleeding Academic Research Consortium ( BARC ) major bleeding unrelated to coronary artery bypass graft surgery .
METHODS	The analysis was by intention to treat .
METHODS	The two-sided was prespecified at 0025 .
METHODS	The trial is registered at ClinicalTrials.gov , number NCT01433627 .
RESULTS	We randomly assigned 8404 patients with acute coronary syndrome , with or without ST-segment elevation , to radial ( 4197 ) or femoral ( 4207 ) access for coronary angiography and percutaneous coronary intervention .
RESULTS	369 ( 88 % ) patients with radial access had major adverse cardiovascular events , compared with 429 ( 103 % ) patients with femoral access ( rate ratio [ RR ] 085 , 95 % CI 074-099 ; p = 00307 ) , non-significant at of 0025.410 ( 98 % ) patients with radial access had net adverse clinical events compared with 486 ( 117 % ) patients with femoral access ( 083 , 95 % CI 073-096 ; p = 00092 ) .
RESULTS	The difference was driven by BARC major bleeding unrelated to coronary artery bypass graft surgery ( 16 % vs 23 % , RR 067 , 95 % CI 049-092 ; p = 0013 ) and all-cause mortality ( 16 % vs 22 % , RR 072 , 95 % CI 053-099 ; p = 0045 ) .
CONCLUSIONS	In patients with acute coronary syndrome undergoing invasive management , radial as compared with femoral access reduces net adverse clinical events , through a reduction in major bleeding and all-cause mortality .
BACKGROUND	The Medicines Company and Terumo .

###24342152
OBJECTIVE	This study investigated whether a tailored approach to heparin and protamine management improved thromboelastometric parameters after cardiopulmonary bypass and reduced postoperative blood loss compared with activated coagulation time ( ACT ) - based fixed target heparin and protamine management .
METHODS	Randomized controlled study .
METHODS	Tertiary university hospital .
METHODS	Patients undergoing elective valve surgery ( n = 38 ) .
METHODS	Heparin and protamine management were based either on the ACT ( n = 19 ) or hemostasis management system ( HMS ) measurements ( n = 19 ; HMS Plus ; Medtronic , Minneapolis , MN ) .
RESULTS	The target ACT for initiation of cardiopulmonary bypass was 480 seconds .
RESULTS	Study variables included rotational thromboelastometry EXTEM ( extrinsic coagulation ) , HEPTEM ( intrinsic coagulation with heparinase ) , and FIBTEM ( fibrin part of clot formation ) tests and 24-hour blood loss .
RESULTS	The use of HMS reduced the median protamine-to-heparin ratio from 1.00 ( 1.00-1 .00 ) to 0.62 ( 0.56-0 .66 ; p < 0.001 ) .
RESULTS	The ACT group showed a prolonged postbypass clotting time for both EXTEM ( 86 13 seconds v 78 10 seconds ; p = 0.05 ) and HEPTEM ( 217 58 seconds v 183 24 seconds ; p = 0.03 ) tests .
RESULTS	There was a moderate correlation between protamine dosing with the EXTEM and HEPTEM clotting time ( r = 0.42 ; p = 0.009 and r = 0.38 ; p = 0.02 , respectively ) .
RESULTS	The number of patients with more than 450 mL/24 hours was higher in the ACT than in the HMS group ( 42 % v 12 % ; p = 0.04 ) .
CONCLUSIONS	Individualized heparin and protamine management decreased the protamine-to-heparin ratio , improved postbypass thromboelastometric hemostatic parameters , and reduced the incidence of severe blood loss compared with an ACT-based strategy , supporting the added value of this approach for hemostatic optimization during cardiac surgery .

###25155428
BACKGROUND	Radiopharmaceutical use may improve the survival time of patients with castrate-resistant prostate cancer and bone metastases .
BACKGROUND	Whether androgen-deprivation therapy ( ADT ) combined with bone-targeted therapy provides a clinical benefit to patients with advanced castrate-sensitive prostate cancer has not been investigated .
METHODS	Eighty male patients were enrolled , and 79 were randomized : 40 to the control arm and 39 to the strontium-89 ( Sr-89 ) arm .
METHODS	After randomization , patients in both study arms received ADT , doxorubicin , and zoledronic acid .
METHODS	Kaplan-Meier methodology was used to evaluate the progression-free survival ( PFS ) time .
METHODS	Multivariate Cox proportional hazards regression was used to evaluate the effects of Sr-89 after controlling for the number of bone metastases .
RESULTS	The median follow-up time for the 29 patients alive at the last follow-up was 76.9 months ( range , 0.07-103 .4 months ) .
RESULTS	The median PFS time was 18.5 months ( 95 % confidence interval , 9.7-49 .4 months ) for the control arm and 12.9 months ( 95 % confidence interval , 8.9-72 .5 months ) for the Sr-89 arm ( P = .86 ) .
RESULTS	No patient developed myelodysplastic syndrome or a hematologic malignancy .
RESULTS	An unplanned subgroup analysis suggested increased efficacy of bone-targeted therapy with a greater extent of bone involvement ( ie , > 6 bone metastases vs 6 bone metastases on the bone scan ) .
CONCLUSIONS	The data showed that bone-targeted therapy using 1 dose of Sr-89 combined with chemohormonal ablation therapy did not favorably affect the PFS of patients with castrate-sensitive prostate cancer .
CONCLUSIONS	The combined therapy was feasible and safe .
CONCLUSIONS	Whether such bone-targeted therapy provides a favorable outcome for those patients with a greater tumor burden in the bone warrants further investigation .

###25443384
OBJECTIVE	Perioperative hemorrhage is an important concern during orthognathic surgery .
OBJECTIVE	The purpose of this study was to assess the effect of tranexamic acid ( TXA ) irrigation on perioperative hemorrhage during orthognathic surgery .
METHODS	In this double-blind , randomized controlled clinical trial , 56 participants who underwent orthognathic surgery were divided into 2 groups .
METHODS	The patients in the first group received TXA irrigation with normal saline ( 1 mg/mL ) , and the patients in the second group had normal saline for irrigation during orthognathic surgery .
METHODS	Age , gender , operation duration , the amount of irrigation solution used , and preoperative hemoglobin , hematocrit , and weight were the variables that were studied .
METHODS	The use of TXA solution for irrigation was the predictive factor of the study .
RESULTS	Each group consisted of 28 patients .
RESULTS	Group 1 consisted of 15 male patients ( 53.6 % ) and 13 female patients ( 46.4 % ) and group 2 consisted of 14 male patients ( 50 % ) and 14 female patients ( 50 % ) .
RESULTS	There was no difference in the distributions of the variables between the 2 groups , except for the duration of the operation .
RESULTS	The mean duration of the operation was 3.94 0.61 hours in group 1 and 4.17 0.98 hours in group 2 , and the difference in this respect between the 2 groups was statistically significant ( P < .05 ) .
RESULTS	The mean intraoperative blood loss was 817.85 261.83 mL in group 1 and 575.00 286.90 mL in group 2 ( P < .05 ) .
RESULTS	The mean volume of irrigation was 1,057.14 407.04 mL in group 1 and 843.57 275.48 mL in group 2 ( P > .05 ) .
CONCLUSIONS	TXA is effective in reducing intraoperative blood loss in patients for whom substantial blood loss is anticipated .

###25153936
OBJECTIVE	This experimental study examined whether listening to self-chosen music after stress exposure improves mood , decreases subjective arousal and rumination , and facilitates cardiovascular recovery .
METHODS	Participants ( N = 123 ) were exposed to a mental arithmetic task with harassment to induce stress .
METHODS	Afterward , participants were randomly assigned to one of four `` recovery '' conditions where they ( 1 ) listened to self-chosen relaxing music , ( 2 ) listened to self-chosen happy music , ( 3 ) listened to an audio book , or ( 4 ) sat in silence .
METHODS	After this 5-minute `` recovery manipulation period , '' participants sat in silence for another 5 minutes .
METHODS	Systolic blood pressure , diastolic blood pressure , and heart rate were continuously measured .
RESULTS	The recovery conditions caused differences in positive affect ( F ( 3,119 ) = 13.13 , p < .001 ) and negative affect ( F ( 3,119 ) = 2.69 , p = .049 ) .
RESULTS	As expected , mood improved while listening to either relaxing music or happy music .
RESULTS	The conditions showed no differences in subjective arousal ( F ( 3,117 ) = 2.03 , p = .11 ) and rumination ( F ( 3,119 ) = 1.10 , p = .35 ) .
RESULTS	Systolic blood pressure recovery , however , differed between the conditions ( linear time trend : F ( 3,116 ) = 4.50 , p = .005 ; quadratic time trend : F ( 3,115 ) = 5.24 , p = .002 ) .
RESULTS	Listening to both relaxing and happy music delayed systolic blood pressure recovery when compared with both control conditions .
CONCLUSIONS	Listening to self-selected music is an effective mood enhancer , but it delays blood pressure recovery .

###24838894
OBJECTIVE	We aimed to evaluate angiotensin receptor blocker add-on therapy in patients with low cardiac output during decompensated heart failure .
METHODS	We selected patients with decompensated heart failure , low cardiac output , dobutamine dependence , and an ejection fraction < 0.45 who were receiving an angiotensin-converting enzyme inhibitor .
METHODS	The patients were randomized to losartan or placebo and underwent invasive hemodynamic and B-type natriuretic peptide measurements at baseline and on the seventh day after intervention .
METHODS	ClinicalTrials.gov : NCT01857999 .
RESULTS	We studied 10 patients in the losartan group and 11 patients in the placebo group .
RESULTS	The patient characteristics were as follows : age 52.7 years , ejection fraction 21.3 % , dobutamine infusion 8.5 mcg/kg .
RESULTS	min , indexed systemic vascular resistance 1918.0 dynes.sec / cm ( 5 ) .
RESULTS	m ( 2 ) , cardiac index 2.8 L/min .
RESULTS	m ( 2 ) , and B-type natriuretic peptide 1,403 pg/mL .
RESULTS	After 7 days of intervention , there was a 37.4 % reduction in the B-type natriuretic peptide levels in the losartan group compared with an 11.9 % increase in the placebo group ( mean difference , -49.1 % ; 95 % confidence interval : -88.1 to -9.8 % , p = 0.018 ) .
RESULTS	No significant difference was observed in the hemodynamic measurements .
CONCLUSIONS	Short-term add-on therapy with losartan reduced B-type natriuretic peptide levels in patients hospitalized for decompensated severe heart failure and low cardiac output with inotrope dependence .

###24238469
BACKGROUND	The resumption of menses is an important indicator of recovery in anorexia nervosa ( AN ) .
BACKGROUND	Patients with early-onset AN are at particularly great risk of suffering from the long-term physical and psychological consequences of persistent gonadal dysfunction .
BACKGROUND	However , the clinical variables that predict the recovery of menstrual function during weight gain in AN remain poorly understood .
BACKGROUND	The aim of this study was to investigate the impact of several clinical parameters on the resumption of menses in first-onset adolescent AN in a large , well-characterized , homogenous sample that was followed-up for 12 months .
METHODS	A total of 172 female adolescent patients with first-onset AN according to DSM-IV criteria were recruited for inclusion in a randomized , multi-center , German clinical trial .
METHODS	Menstrual status and clinical variables ( i.e. , premorbid body mass index ( BMI ) , age at onset , duration of illness , duration of hospital treatment , achievement of target weight at discharge , and BMI ) were assessed at the time of admission to or discharge from hospital treatment and at a 12-month follow-up .
METHODS	Based on German reference data , we calculated the percentage of expected body weight ( % EBW ) , BMI percentile , and BMI standard deviation score ( BMI-SDS ) for all time points to investigate the relationship between different weight measurements and resumption of menses .
RESULTS	Forty-seven percent of the patients spontaneously began menstruating during the follow-up period .
RESULTS	% EBW at the 12-month follow-up was strongly correlated with the resumption of menses .
RESULTS	The absence of menarche before admission , a higher premorbid BMI , discharge below target weight , and a longer duration of hospital treatment were the most relevant prognostic factors for continued amenorrhea .
CONCLUSIONS	The recovery of menstrual function in adolescent patients with AN should be a major treatment goal to prevent severe long-term physical and psychological sequelae .
CONCLUSIONS	Patients with premenarchal onset of AN are at particular risk for protracted amenorrhea despite weight rehabilitation .
CONCLUSIONS	Reaching and maintaining a target weight between the 15th and 20th BMI percentile is favorable for the resumption of menses within 12 months .
CONCLUSIONS	Whether patients with a higher premorbid BMI may benefit from a higher target weight needs to be investigated in further studies .

###24989854
BACKGROUND	Social skills training ( SST ) is a common intervention for children with autism spectrum disorders ( ASDs ) to improve their social and communication skills .
BACKGROUND	Despite the fact that SSTs are often applied in clinical practice , the evidence for the effectiveness of these trainings for children with ASD is inconclusive .
BACKGROUND	Moreover , long term outcome and generalization of learned skills are little evaluated .
BACKGROUND	Additionally , there is no research on the influence of involvement of parents and teachers on effectiveness of SST and on the generalization of learned social skills to daily life .
BACKGROUND	We expect parent and teacher involvement in SST to enhance treatment efficacy and to facilitate generalization of learned skills to daily life .
METHODS	In a randomized controlled trial ( RCT ) with three conditions , 120 participants with ASD at the end of primary school ( 10-12 years of calendar age ) have been randomized to SST , SST-PTI ( SST with Parent & Teacher Involvement ) , or care-as-usual .
METHODS	The SST consists of 18 group sessions of 1.5 hours for the children .
METHODS	In the SST-PTI condition , parents additionally participate in 8 parent sessions and parents and teachers are actively involved in homework assignments .
METHODS	Assessment takes place at three moments : before and immediately after the intervention period and at 6 months follow-up .
METHODS	Primary outcome is socialization , as an aspect of adaptive functioning .
METHODS	Secondary outcomes focus on specific social skills children learn during SST and on more general social skills pertaining to home and community settings from a multi-informant perspective .
METHODS	Additionally , possible predictors of treatment outcome will be assessed .
CONCLUSIONS	The current study is an RCT study evaluating SST in a large sample of Dutch children with ASD in a specific age range ( 10-12 years ) .
CONCLUSIONS	Strengths of the study are the use of one manualized protocol , application of standardized and internationally used rating instruments , use of multiple raters , investigation of generalization of learned skills to daily life , and the evaluation of efficacy in the longer term by follow-up measures at 6 months after the end of training .
BACKGROUND	NTR2405 .

###24549145
OBJECTIVE	Immune factors determining clinical progression following HIV-1 infection remain unclear .
OBJECTIVE	The SPARTAC trial randomized 366 participants in primary HIV infection ( PHI ) to different short-course therapies .
OBJECTIVE	The aim of this study was to investigate how early immune responses in PHI impacted clinical progression in SPARTAC .
METHODS	Participants with PHI recruited to the SPARTAC trial were sampled at enrolment , prior to commencing any therapy .
METHODS	HIV-1-specific CD4 ( + ) and CD8 ( + ) ELISpot responses were measured by gamma interferon ELISPOT .
METHODS	Immunological data were associated with baseline covariates and times to clinical progression using logistic regression , Kaplan-Meier plots , and Cox models .
RESULTS	Making a CD4 ( + ) T-cell ELISpot response ( n = 119 ) at enrolment was associated with higher CD4 ( + ) cell counts ( P = 0.02 ) and to some extent lower plasma HIV RNA ( P = 0.07 ) .
RESULTS	There was no correlation between the number of overlapping Gag CD8 ( + ) T-cell ELISpot responses ( n = 138 ) and plasma HIV-1 RNA viral load .
RESULTS	Over a median follow-up of 2.9 years , baseline CD4 ( + ) cell ELISpot responses ( n = 119 ) were associated with slower clinical progression ( P = 0.01 ; log-rank ) .
RESULTS	Over a median of 3.1 years , there was no evidence for a survival advantage imposed by CD8 ( + ) T-cell immunity ( P = 0.82 ) .
CONCLUSIONS	These data support a dominant protective role for CD4 ( + ) T-cell immunity in PHI compared with CD8 ( + ) T-cell responses , and are highly pertinent to HIV pathogenesis and vaccines , indicating that vaccine-induced CD4 ( + ) responses may confer sustained benefit .

###25481190
OBJECTIVE	To explore clinical effect of Bacillus Calmette-Guerin polysaccharide nucleic acid ( BCG PSN ) combined with CO ( 2 ) laser for vitiligo and its impact on Th17 cells and Th17 associated cytokines in patients with vitiligo .
METHODS	The patients ( n = 102 ) with vitiligo from June 2011 to October 2013 in our hospital were randomly divided into control group ( n = 51 ) and observation group ( n = 51 ) .
METHODS	Patients in the control group were treated with CO ( 2 ) laser .
METHODS	Patients in the observation group were treated with BCG PSN besides CO ( 2 ) laser .
METHODS	The total treatment efficacy in the two groups was appraised .
METHODS	Th17 cell populations in peripheral blood were analyzed by flow cytometry .
METHODS	IL-17 and IL-23 levels in peripheral blood were determined by ELISA .
METHODS	The expressions of IL-17 and IL-23 mRNA in cutaneous lesion tissues were detected by real-time quantitative PCR .
RESULTS	Total treatment efficacy in the observation group was significantly better than that of the control group .
RESULTS	Compared with the control group after treatment , Th17 lymphocyte subsets in the observation group after treatment were significantly reduced in peripheral blood , the levels of serum IL-17 and IL-23 in the peripheral blood significantly dropped , and the expressions of IL-17 and IL-23 mRNA in cutaneous lesion tissues also decreased significantly .
CONCLUSIONS	BCG PSN combined with CO ( 2 ) laser can down-regulate Th17 lymphocyte subsets and Th17 associated cytokines in peripheral blood and cutaneous lesion .
CONCLUSIONS	It has a good clinical efficacy for treating vitiligo .

###24637543
OBJECTIVE	Prior studies have found that early HIV protease inhibitors contribute to glucose dysregulation .
OBJECTIVE	Few randomized trials have evaluated glucose indices in antiretroviral-naive individuals on newer antiretroviral therapy ( ART ) .
METHODS	A5224s was a substudy of A5202 , a prospective trial of 1857 ART-naive participants randomized to blinded abacavir-lamivudine ( ABC/3TC ) or tenofovir DF-emtricitabine ( TDF/FTC ) with open-label efavirenz ( EFV ) or atazanavir-ritonavir ( ATV/r ) .
METHODS	Analyses used two-sample t-tests , Spearman correlation coefficients and linear regression .
RESULTS	A5224s included 269 nondiabetic individuals : 85 % men , 47 % white non-Hispanic , baseline median age 38 years , HIV-1 RNA 4.6 log10 copies/ml and CD4 cell count 233 cells/l .
RESULTS	Overall , significant 96-week increases occurred in fasting glucose , insulin and the homeostatic model assessment of insulin resistance ( HOMA-IR ) , P 0.004 .
RESULTS	Assignment to EFV ( versus ATV/r ) resulted in significantly greater glucose increase [ mean difference 4.4 ; 95 % confidence interval ( CI ) 1.3 , 7.5 mg/dl ; P = 0.006 ] but not insulin or HOMA-IR ( P 0.72 ) .
RESULTS	Glucose indices were not significantly different between ABC/3TC and TDF/FTC arms , P 0.18 .
RESULTS	Significant correlations were detected between changes in glucose indices and changes in BMI ; all r 0.23 , P 0.001 .
RESULTS	In multivariable analyses , in addition to the EFV effect , higher baseline HIV-1 RNA and greater BMI change were significant independent factors associated with greater glucose increase .
CONCLUSIONS	Changes in glucose metabolism were not significantly different between TDF/FTC and ABC/3TC-based regimens .
CONCLUSIONS	A small but significantly greater increase in glucose was observed in those assigned to EFV .
CONCLUSIONS	As glucose dysregulation may increase with time on ART , longer term studies will be needed to further clarify the clinical significance of these findings .

###24481143
OBJECTIVE	The aim of this prospective single-blinded study was to analyze the stone-free ( SF ) rates between pneumatic lithotripsy ( PL ) and laser lithotripsy ( LL ) for the treatment of single and primary ureteral stones and to evaluate potentially predictive factors of a SF status .
METHODS	From January 2010 to January 2011 , 133 consecutive patients with single and primary ureteral stones were prospectively enrolled .
METHODS	Uni - and multivariate logistic regression were performed to estimate predictive factors of a SF status .
RESULTS	The SF rate in the PL group was 80.7 and 86.1 % in the LL group ( p = 0.002 ) .
RESULTS	Success rates with regard of stone position were not significantly different between groups .
RESULTS	At univariate logistic regression , middle ureteral stone ( OR 3.33 , p = 0.04 ) , distal ureteral stone ( OR 4.4 , p = 0.02 ) , LL ( OR 3.05 , p = 0.04 ) and Hounsfield units ( HUs ) ( OR 1.07 , p = 0.03 ) were significantly predictive factors of a SF status .
RESULTS	At a multivariate logistic regression , middle ureteral stone ( OR 5.58 , p = 0.01 ) , distal ureteral stone ( OR 7.87 , p < 0.01 ) , LL ( OR 2.4 , p = 0.02 ) and HUs 1,200 ( OR 1.15 , p = 0.02 ) were significantly associated with a SF status .
CONCLUSIONS	LL significantly influences the SF status after ureteroscopy , allowing a higher SF rate when compared to PL .
CONCLUSIONS	HUs may significantly influence this success rate .

###24624990
BACKGROUND	Anxiety in children is common and incapacitating and increases the risk of mental health disorders in adulthood .
BACKGROUND	Although effective interventions are available , few children are identified and referred for specialist treatment .
BACKGROUND	Alternative approaches in which prevention programmes are delivered in school appear promising .
BACKGROUND	However , comparatively little is known about the best intervention leader ( health care-led vs. school-led ) , long-term effects or the primary preventive value of such programmes .
METHODS	Preventing Anxiety in Children through Education in Schools , or PACES , is a pragmatic cluster randomised controlled trial evaluating the effectiveness of a cognitive-behavioural therapy prevention programme ( FRIENDS ) on symptoms of anxiety and low mood in 9 - to 10-year-old children .
METHODS	Forty-one schools were randomly assigned to one of three conditions : school-led FRIENDS , health care-led FRIENDS or treatment as usual .
METHODS	Assessments were undertaken at baseline , 6 months and 12 months , with the primary outcome measure being the Revised Child Anxiety and Depression Scale score at 12 months .
METHODS	Secondary outcome measures are changes in self-esteem , worries , bullying and life satisfaction .
CONCLUSIONS	This protocol summarises the procedure for the 24-month follow-up of this cohort .
CONCLUSIONS	The study will determine the medium-term effectiveness of an anxiety prevention programme delivered in schools .
BACKGROUND	ISRCTN23563048 .

###25385207
BACKGROUND	There is emerging consensus that enhanced inter-professional teamwork is necessary for the effective and efficient delivery of primary care , but there is less practical information specific to primary care available to guide practices on how to better work as teams .
OBJECTIVE	The purpose of this study was to describe how primary care practices have overcome challenges to providing team-based primary care and the implications for care delivery and policy .
METHODS	Practices for this qualitative study were selected from those recognized as patient-centered medical homes ( PCMHs ) via the most recent National Committee for Quality Assurance PCMH tool , which included a domain on practice teamwork .
METHODS	Sixty-three respondents , ranging from physicians to front-desk staff , were interviewed from May through December of 2013 .
METHODS	Practice respondents came from 27 primary care practices ranging in size , type , geography , and population served .
RESULTS	Practices emphasizing teamwork overcame common challenges through the incremental delegation of non-clinical tasks away from physicians .
RESULTS	The roles of medical assistants and nurses are expanding to include template-guided information collection from patients prior to the physician office visit as well as many other tasks .
RESULTS	The inclusion of staff input in care workflow redesign and the use of data to demonstrate how team care process changes improved patient care were helpful in gaining staff buy-in .
RESULTS	Team `` huddles '' guided by pre-visit planning were reported to assist in role delegation , consistency of information collected from patients , and structured communication among team members .
RESULTS	Nurse care managers were found to be important team members in working with patients and their physicians on care plan design and execution .
RESULTS	Most practices had not participated in formal teamwork training , but respondents expressed a desire for training for key team members , particularly if they could access it on-site ( e.g. , via practice coaches or the Internet ) .
CONCLUSIONS	Participants who adopted new forms of delegation and care processes using teamwork approaches , and who were supported with resources , system support , and data feedback , reported improved provider satisfaction and productivity .
CONCLUSIONS	There appears to be a need for more on-site teamwork training .

###24362411
OBJECTIVE	The effect of metformin on weight reduction in polycystic ovary syndrome ( PCOS ) is often unsatisfactory .
OBJECTIVE	In this study , we investigated the potential add-on effect of treatment with the glucagon-like peptide-1 receptor agonist liraglutide on weight loss in obese nondiabetic women with PCOS who had lost < 5 % body weight during pretreatment with metformin .
METHODS	A total of 40 obese women with PCOS , who had been pretreated with metformin for at least 6 months , participated in a 12-week open-label , prospective study .
METHODS	They were randomized to one of three treatment arms : metformin ( MET ) arm 1000 mg BID , liraglutide ( LIRA ) arm 1.2 mg QD s.c. , or combined MET 1000 mg BID and LIRA ( COMBI ) 1.2 mg QD s.c. Lifestyle intervention was not actively promoted .
METHODS	The primary outcome was change in body weight .
RESULTS	Thirty six patients ( aged 31.3 7.1 years , BMI 37.1 4.6 kg/m ) completed the study : 14 on MET , 11 on LIRA , and 11 on combined treatment .
RESULTS	COMBI therapy was superior to LIRA and MET monotherapy in reducing weight , BMI , and waist circumference .
RESULTS	Subjects treated with COMBI lost on average 6.5 2.8 kg compared with a 3.8 3.7 kg loss in the LIRA group and a 1.2 1.4 kg loss in the MET group ( P < 0.001 ) .
RESULTS	The extent of weight loss was stratified : a total of 38 % of subjects were high responders who lost 5 % body weight , 22 % of them in the COMBI arm compared with 16 and 0 % in the LIRA and MET arm respectively .
RESULTS	BMI decreased by 2.4 1.0 in the COMBI arm compared with 1.3 1.3 in LIRA and 0.5 0.5 in the MET arm ( P < 0.001 ) .
RESULTS	Waist circumference also decreased by 5.5 3.8 cm in the COMBI arm compared with 3.2 2.9 cm in LIRA and 1.6 2.9 cm in the MET arm ( P = 0.029 ) .
RESULTS	Subjects treated with liraglutide experienced more nausea than those treated with metformin , but severity of nausea decreased over time and did not correlate with weight loss .
CONCLUSIONS	Short-term combined treatment with liraglutide and metformin was associated with significant weight loss and decrease in waist circumference in obese women with PCOS who had previously been poor responders regarding weight reduction on metformin monotherapy .

###25442120
BACKGROUND	Probiotics may help resolve bowel symptoms and improve quality of life .
BACKGROUND	We investigated the effects of 12 weeks of probiotics administration in colorectal cancer patients .
METHODS	We conducted a double-blind , randomized , placebo-controlled trial .
METHODS	The participants took probiotics ( Lacidofil ) or placebo twice a day for 12 weeks .
METHODS	The cancer-related quality of life ( FACT ) , patient 's health-9 ( PHQ-9 ) , and bowel symptom questionnaires were completed by each participant .
RESULTS	We obtained data for 32 participants in the placebo group and 28 participants in the probiotics group .
RESULTS	The mean ages of total participants were 56.18 .86 years and 58.3 % were male .
RESULTS	Administration of probiotics significantly decreased the proportion of patients suffering from irritable bowel symptoms ( 0 week vs. 12 week ; 67.9 % vs. 45.7 % , p = 0.03 ) , improved colorectal cancer-related FACT ( baseline vs. 12 weeks : 19.79 4.66 vs. 21.18 3.67 , p = 0.04 ) and fatigue-related FACT ( baseline vs. 12 weeks : 43.00 ( 36.50-45 .50 ) vs. 44.50 ( 38.50-49 .00 ) , p = 0.02 ) and PHQ-9 scores ( 0 weeks vs. 12 weeks ; 3.00 ( 0-8 .00 ) vs. 1.00 ( 0-3 .00 ) , p = 0.01 ) .
RESULTS	We found significant differences in changes of the proportion of patients with bowel symptoms ( p < 0.05 ) , functional well-being scores ( p = 0.04 ) and cancer-related FACT scores ( p = 0.04 ) between the two groups .
CONCLUSIONS	Probiotics improved bowel symptoms and quality of life in colorectal cancer survivors .

###25312876
OBJECTIVE	To describe Action Schools !
OBJECTIVE	BC ( AS !
OBJECTIVE	BC ) from efficacy to scale-up .
METHODS	Education and health system stakeholders and children in grades 4-6 from elementary schools in British Columbia , Canada .
METHODS	At the provincial level , the AS !
METHODS	BC model reflected socioecological theory and a partnership approach to social change .
METHODS	Knowledge translation and exchange were embedded as a foundational element .
METHODS	At the school level , AS !
METHODS	BC is a comprehensive school health-based model providing teachers and schools with training and resources to integrate physical activity ( PA ) and healthy eating ( HE ) into the school environment .
METHODS	Our research team partnered with key community and government stakeholders to deliver and evaluate AS !
METHODS	BC over efficacy , effectiveness and implementation trials .
RESULTS	On the basis of significant increases in PA , cardiovascular fitness , bone and HE in AS !
RESULTS	BC schools during efficacy trials , the BC government supported a provincial scale-up .
RESULTS	Since its inception , the AS !
RESULTS	BC Support Team and > 225 trained regional trainers have delivered 4677 teacher-focused workshops ( training approximately 81,000 teachers ) , reaching approximately 500,000 students .
RESULTS	After scale-up , PA delivery was replicated but the magnitude of change appeared less .
RESULTS	One ( HE ) and 4 ( PA ) years after scale-up , trained AS !
RESULTS	BC teachers provided more PA and HE opportunities for students even in the context of supportive provincial policies .
CONCLUSIONS	Whole school models like AS !
CONCLUSIONS	BC can enhance children 's PA and health when implemented in partnership with key stakeholders .
CONCLUSIONS	At the school level , adequately trained and resourced teachers and supportive school policies promoted successful scale-up and sustained implementation .
CONCLUSIONS	At the provincial level , multisectoral partnerships and embedded knowledge exchange mechanisms influenced the context for action at the provincial and school level , and were core elements of successful implementation .
BACKGROUND	Clinical Trials Registry NCT01412203 .

###24463236
BACKGROUND	Although resistance training adaptations in multiple sclerosis ( MS ) patients have been described , the detraining response in this population is largely unknown .
OBJECTIVE	[ corrected ] This study was designed to evaluate the effects of a 12-week detraining period on muscle strength ( isometric and endurance ) and muscle power of multiple sclerosis ( MS ) patients that had previously carried out a 12-week resistance training program ( RTP ) .
METHODS	Forty-two MS patients were randomly assigned into two groups : an exercise group ( EG ) that performed a 12-week RTP for the knee extensors muscles ; and a control group ( CG ) , that did not perform any specific training .
METHODS	Knee extension maximal voluntary isometric contraction ( MVIC ) , muscle power and muscle endurance were evaluated before and after the RTP , as well as 12 weeks after training completion .
METHODS	A strain gauge was used to measure the maximal voluntary isometric contraction and muscle power was assessed with a linear encoder .
METHODS	Muscle endurance was interpreted as the number of repetitions that a patient could perform in a single set of knee extension exercise .
RESULTS	The EG increased MVIC and muscle power after the training period , although the training did not affect muscle endurance .
RESULTS	After 12 weeks of detraining , MVIC returned to pre-training values but muscle power was still greater than pre-training values in the EG .
RESULTS	The CG did not present any change in the variables measured during the intervention .
CONCLUSIONS	A 12-week RTP improved MVIC and muscle power in MS patients .
CONCLUSIONS	Additionally , 12 weeks of detraining blunted strength training adaptations in MS patients , although muscle power training adaptations were still evident after the detraining period .

###25549193
BACKGROUND	Central neurological injury ( CNI ) is a major contributor to physical disability that affects both adults and children all over the world .
BACKGROUND	The main sequelae of chronic stage CNI are spasticity , paresis of specific muscles , and poor selective motor control .
BACKGROUND	Here , we apply the concept of contralateral peripheral neurotization in spasticity releasing and motor function restoration of the affected upper extremity .
OBJECTIVE	A clinical investigation was performed to verify the clinical efficacy of contralateral C7 neurotization for rescuing the affected upper extremity after CNI .
METHODS	In the present study , 6 adult hemiplegia patients received the nerve transfer surgery of contralateral C7 to C7 of the affected side .
METHODS	Another 6 patients with matched pathological and demographic status were assigned to the control group that received rehabilitation only .
METHODS	During the 2-year follow-up , muscle strength of bilateral upper extremities was assessed .
METHODS	The Modified Ashworth Scale and Fugl-Meyer Assessment Scale were used for evaluating spasticity and functional use of the affected upper extremity , respectively .
RESULTS	Both flexor spasticity release and motor functional improvements were observed in the affected upper extremity in all 6 patients who had surgery .
RESULTS	The muscle strength of the extensor muscles and the motor control of the affected upper extremity improved significantly .
RESULTS	There was no permanent loss of sensorimotor function of the unaffected upper extremity .
CONCLUSIONS	This contralateral C7 neurotization approach may open a door to promote functional recovery of upper extremity paralysis after CNI .

###24448288
OBJECTIVE	To assess the safety and the possible advantages of early ( 1-wk ) cochlear implant switch-on in children and to compare impedance and ECAP threshold changes between subjects undergoing early switch-on and those undergoing traditional , 1-month switch-on .
METHODS	Prospective cohort study .
METHODS	Tertiary care referral pediatric center .
METHODS	Seventeen children receiving a unilateral or bilateral Nucleus Freedom cochlear implant were included , for a total of 20 ears .
METHODS	Ten ears were assigned to the early ( 1-wk ) switch-on group and 10 to the control group ( switch-on after 4 wks ) .
METHODS	Common ground impedance values and electrically evoked compound action potential thresholds were measured from intraoperation until 9 months postoperatively .
METHODS	Speech perception improvements over time were also assessed .
METHODS	Complication rate , impedance levels ( k ) , and electrically evoked compound action potentials ( current levels )
RESULTS	Early switch-on was well tolerated by patients and did not cause complications .
RESULTS	Impedances dropped significantly after switch-on in both groups .
RESULTS	They also seemed to achieve an earlier stability in the early switch-on patients , although the difference between groups was not significant .
RESULTS	ECAP thresholds showed a similar , nonsignificant decreasing trend over time in both groups .
RESULTS	Speech perception improvements did not differ between groups .
CONCLUSIONS	This is the first study investigating the safety and the effects of an early cochlear implant switch-on in children .
CONCLUSIONS	Results show that such a procedure is well tolerated by pediatric subjects and free from complications .
CONCLUSIONS	Impedance measurements suggest that the earlier switched-on subjects benefit of lower and more stable impedances than subjects undergoing 1-month switch-on .

###25014995
BACKGROUND	The electronic self report assessment - cancer ( ESRA-C ) , has been shown to reduce symptom distress during cancer therapy The purpose of this analysis was to evaluate aspects of how the ESRA-C intervention may have resulted in lower symptom distress ( SD ) .
METHODS	Patients at two cancer centers were randomized to ESRA-C assessment only ( control ) or the Web-based ESRA-C intervention delivered to patients ' homes or to a tablet in clinic .
METHODS	The intervention allowed patients to self-monitor symptom and quality of life ( SxQOL ) between visits , receive self-care education and coaching to report SxQOL to clinicians .
METHODS	Summaries of assessments were delivered to clinicians in both groups .
METHODS	Audio-recordings of clinic visits made 6 weeks after treatment initiation were coded for discussions of 26 SxQOL issues , focusing on patients ' / caregivers ' coached verbal reports of SxQOL severity , pattern , alleviating/aggravating factors and requests for help .
METHODS	Among issues identified as problematic , two measures were defined for each patient : the percent SxQOL reported that included a coached statement , and an index of verbalized coached statements per SxQOL .
METHODS	The Wilcoxon rank test was used to compare measures between groups .
METHODS	Clinician responses to problematic SxQOL were compared .
METHODS	A mediation analysis was conducted , exploring the effect of verbal reports on SD outcomes .
RESULTS	517 ( 256 intervention ) clinic visits were audio-recorded .
RESULTS	General discussion of problematic SxQOL was similar in both groups .
RESULTS	Control group patients reported a median 75 % of problematic SxQOL using any specific coached statement compared to a median 85 % in the intervention group ( p = .0009 ) .
RESULTS	The median report index of coached statements was 0.25 for the control group and 0.31 for the intervention group ( p = 0.008 ) .
RESULTS	Fatigue , pain and physical function issues were reported significantly more often in the intervention group ( all p < .05 ) .
RESULTS	Clinicians ' verbalized responses did not differ between groups .
RESULTS	Patients ' verbal reports did not mediate final SD outcomes ( p = .41 ) .
CONCLUSIONS	Adding electronically-delivered , self-care instructions and communication coaching to ESRA-C promoted specific patient descriptions of problematic SxQOL issues compared with ESRA-C assessment alone .
CONCLUSIONS	However , clinician verbal responses were no different and subsequent symptom distress group differences were not mediated by the patients ' reports .
BACKGROUND	NCT00852852 ; 26 Feb 2009 .

###25300286
BACKGROUND	Endothelial progenitor cells ( EPC ) are bone marrow-derived cells which can undergo differentiation into endothelial cells and participate in endothelial repair and angiogenesis .
BACKGROUND	Insulin facilitates this in vitro mediated by the IGF-1 receptor .
BACKGROUND	Clinical trials showed that the number of circulating EPCs is influenced by glucose control and EPC are a predictor of cardiovascular death .
BACKGROUND	To study direct effects of insulin treatment on EPCs in type 2 diabetes patients , add-on basal insulin treatment was compared to an escalation of oral medication aiming at similar glucose control between the groups .
METHODS	55 patients with type 2 diabetes ( 61.65.9 years ) on oral diabetes medication were randomized in a 2:2:1 ratio in 3 groups .
METHODS	Patients were treated additionally with insulin glargine ( n = 20 ) , NPH insulin ( n = 22 ) or escalated with oral medication ( n = 13 ) .
METHODS	Number of circulating EPC , EPC-outgrowth , intima media thickness , skin microvascular function and HbA1c were documented at baseline and/or after 4 weeks and 4 months .
RESULTS	HbA1c at baseline was , 7.3 + / -0.7 % in the oral group , 7.3 + / -0.9 % and 7.5 + / -0.7 % in the glargine and NPH insulin respectively ( p = 0.713 ) .
RESULTS	HbA1c after 4 months decreased to 6.8 + / -0.8 % , 6.6 + / -0.7 % and 6.7 + / -0.6 % , in the oral , glargine and NPH insulin group respectively ( p = 0.61 ) .
RESULTS	FACS analysis showed no difference in number of circulating EPC between the groups after 4 weeks and 4 months .
RESULTS	However , the outgrowth of EPCs as detected by colony forming assay was increased in the NPH insulin and glargine groups ( 29.2 + / -6.4 and 29.4 + / - 6.7 units respectively ) compared to the group on oral medication ( 23.2 + / -6.3 , p = 0.013 ) after 4 months of treatment .
RESULTS	A significant decrease of IMT from 0.80 mm ( + / -0.14 ) at baseline to 0.76 mm ( + / -0.12 ) after 4 months could be observed in all patients only ( p = 0.03 ) with a trend towards a reduction of IMT after 4 months when all patients on insulin treatment were compared to the oral treatment group ( p = 0.06 ) .
RESULTS	Skin microvascular function revealed no differences between the groups ( p = 0.74 ) .
CONCLUSIONS	The study shows that a 4-month treatment with add-on insulin significantly increases the outgrowth of EPC in patients with type 2 diabetes mellitus .
BACKGROUND	( Clinical Trials Identifier : NCT00523393 ) .

###24859203
OBJECTIVE	There is an increasing need for new treatments for patients with Crohn 's disease ( CD ) in whom previous therapy with tumor necrosis factor ( TNF ) antagonists has failed .
OBJECTIVE	We performed a placebo-controlled , phase 3 , double-blind trial to evaluate the efficacy and safety of vedolizumab , an antibody against the integrin 47 , as induction therapy .
METHODS	Patients with moderately to severely active CD ( CD activity index [ CDAI ] score , 220-400 points ) were assigned randomly to groups given vedolizumab ( 300 mg ) or placebo intravenously at weeks 0 , 2 , and 6 .
METHODS	The primary analysis involved 315 patients with previous TNF antagonist failure ( ie , an inadequate response to , loss of response to , or intolerance of 1 TNF antagonists ) ; we determined the proportion of patients in clinical remission ( CDAI , 150 points ) at week 6 .
METHODS	Secondary analyses evaluated outcomes at weeks 6 and 10 in this population and in the overall population ( N = 416 ) , which included patients naive to TNF antagonist therapy ( n = 101 ) .
RESULTS	Among patients who had experienced previous TNF antagonist failure , 15.2 % of those given vedolizumab and 12.1 % of those given placebo were in remission at week 6 ( P = .433 ) .
RESULTS	At week 10 , a higher proportion of this population given vedolizumab was in remission ( 26.6 % ) than those given placebo ( 12.1 % ) ( nominal P = .001 ; relative risk , 2.2 ; 95 % confidence interval , 1.3-3 .6 ) .
RESULTS	A higher proportion of patients with previous TNF antagonist failure given vedolizumab also had a CDAI-100 response ( 100-point decrease in CDAI score from baseline ) at week 6 than those given placebo ( 39.2 % vs 22.3 % ; nominal P = .001 ; relative risk , 1.8 ; 95 % confidence interval , 1.2-2 .5 ) .
RESULTS	Adverse event results were similar among all groups .
CONCLUSIONS	Vedolizumab was not more effective than placebo in inducing clinical remission at week 6 among patients with CD in whom previous treatment with TNF antagonists had failed .
CONCLUSIONS	The therapeutic benefits of vedolizumab in these patients were detectable at week 10 .
CONCLUSIONS	ClinicalTrials.gov number : NCT01224171 .

###25332331
BACKGROUND	Proper caloric intake goals in critically ill surgical patients are unclear .
BACKGROUND	It is possible that overnutrition can lead to hyperglycemia and an increased risk of infection .
OBJECTIVE	This study was conducted to determine whether surgical infection outcomes in the intensive care unit ( ICU ) could be improved with the use of hypocaloric nutritional support .
METHODS	Eighty-three critically ill patients were randomly allocated to receive either the standard calculated daily caloric requirement of 25-30 kcal kg ( -1 ) d ( -1 ) ( eucaloric ) or 50 % of that value ( hypocaloric ) via enteral tube feeds or parenteral nutrition , with an equal protein allocation in each group ( 1.5 g kg ( -1 ) d ( -1 ) ) .
RESULTS	There were 82 infections in the hypocaloric group and 66 in the eucaloric group , with no significant difference in the mean ( SE ) number of infections per patient ( 2.0 0.6 and 1.6 0.2 , respectively ; P = 0.50 ) , percentage of patients acquiring infection [ 70.7 % ( 29 of 41 ) and 76.2 % ( 32 of 42 ) , respectively ; P = 0.57 ] , mean ICU length of stay ( 16.7 2.7 and 13.5 1.1 d , respectively ; P = 0.28 ) , mean hospital length of stay ( 35.2 4.9 and 31.0 2.5 d , respectively ; P = 0.45 ) , mean 0600 glucose concentration ( 132 2.9 and 135 3.1 mg/dL , respectively ; P = 0.63 ) , or number of mortalities [ 3 ( 7.3 % ) and 4 ( 9.5 % ) , respectively ; P = 0.72 ] .
RESULTS	Further analyses revealed no differences when analyzed by sex , admission diagnosis , site of infection , or causative organism .
CONCLUSIONS	Among critically ill surgical patients , caloric provision across a wide acceptable range does not appear to be associated with major outcomes , including infectious complications .
CONCLUSIONS	The optimum target for caloric provision remains elusive .

###24972677
BACKGROUND	Curry , one of the most popular foods in Japan , contains spices that are rich in potentially antioxidative compounds , such as curcumin and eugenol .
BACKGROUND	Oxidative stress is thought to impair endothelial function associated with atherosclerosis , a leading cause of cardiovascular events .
BACKGROUND	The aim of this study was to determine whether a single consumption of curry meal would improve endothelial function in healthy men .
METHODS	Fourteen healthy male subjects ( BMI 23.72.7 kg/m2 ; age 459years ) were given a single serving of curry meal or spice-free control meal ( 180g of curry or control and 200g of cooked rice ; approximately 500kcal in total ) in a randomized , controlled crossover design .
METHODS	Before and 1hr after the consumption , fasting and postprandial flow-mediated vasodilation ( FMD ) responses and other parameters were measured .
RESULTS	The consumption of the control meal decreased FMD from 5.82.4 % to 5.12.3 % ( P = 0.039 ) .
RESULTS	On the other hand , the consumption of the curry meal increased FMD from 5.22.5 % to 6.62.0 % ( P = 0.001 ) , and the postprandial FMD after the curry meal was higher than that after the control meal ( P = 0.002 ) .
RESULTS	Presence of spices in the curry did not alter significantly the systemic and forearm hemodynamics , or any biochemical parameters including oxidative stress markers measured .
CONCLUSIONS	These findings suggest that the consumption of curry ameliorates postprandial endothelial function in healthy male subjects and may be beneficial for improving cardiovascular health .
BACKGROUND	UMIN Clinical Trials Registry 000012012 .

###25197990
OBJECTIVE	This study 's purpose was to investigate the effect of a glass ionomer cement as a liner over infected unexcavated dentin after 60 days and at 10 to 15 months .
METHODS	Forty-five permanent molars with deep carious lesions were selected .
METHODS	Fragments of carious dentin were removed prior to lining the cavity ( baseline sample ) with glass ionomer cement ( G1 ) or an inert wax material ( G2 ) .
METHODS	Cavities were restored with composite resin and reopened 60 days later , when other fragments were removed ( 60-day sample ) .
METHODS	The dentin morphology ( scanning electron microscopy ) and mineral content of calcium , phosphorus , and fluorine were assessed .
METHODS	During the follow-up periods ( 60 days and 10 to 15 months ) , restorations were evaluated and standardized radiographs were taken .
METHODS	A postprocessing routine was used to identify changes in the radiographic density between periods .
RESULTS	After 60 days , the dentin exhibited a better organization , fewer bacteria , and signs of remineralization .
RESULTS	The weight percents of calcium and phosphorus were higher 60 days after the cavity sealing , regardless of the group .
RESULTS	Higher gray levels of carious and sound dentin were seen on the 10 - to 15-month radiographs , irrespective of the group .
RESULTS	The success rates of G1 and G2 were 89 percent and 88 percent , respectively .
CONCLUSIONS	The lining material is n't fundamental for caries arrestment .
CONCLUSIONS	Early ( 60-day ) and late ( 10 to 15 months ) dentin changes occurred , indicating the remineralization of dentin carious tissue .

###25297721
OBJECTIVE	There is a lack of evidence on the best treatment option for umbilical granuloma .
OBJECTIVE	The primary aim of this study was to compare three treatments for umbilical granuloma : standard treatment with topical silver nitrate , clobetasol propionate cream ( 0.05 % ) and ethanol wipes .
OBJECTIVE	The secondary aim was to evaluate whether the treatment could be successfully administered by a parent at home , rather than in the outpatient clinic .
METHODS	A total of 109 infants were randomised to one of three groups and 94 infants completed the assigned treatment : 30 infants received standard treatment with silver nitrate ( 99 % ) in the outpatient clinic , 30 infants had topical clobetasol propionate cream ( 0.05 % ) applied at home , and 34 infants received cleansing with ethanol wipes ( 82 % ) at home .
RESULTS	Silver nitrate and clobetasol propionate cream ( 0.05 % ) were significantly superior to ethanol wipes , with shorter healing times and higher resolution rates ( p = 0.0001 ) .
RESULTS	Healing time and resolution rates were identical for silver nitrate and clobetasol propionate cream ( 0.05 % ) .
RESULTS	Mild side effects were occasionally reported , all of which were self-limiting .
CONCLUSIONS	Treating umbilical granuloma with topical clobetasol propionate cream ( 0.05 % ) at home is as effective as treating it with topical silver nitrate ( 99 % ) in the clinic .

###24764337
OBJECTIVE	The purpose of this study was to evaluate the diagnostic performance and interobserver agreement of 2-dimensional ( 2D ) and 3-dimensional ( 3D ) sonography for evaluating extrathyroidal extension of papillary thyroid carcinoma .
METHODS	A total of 79 papillary thyroid carcinomas in 79 patients who underwent both 2D and 3D sonography for preoperative staging of papillary thyroid carcinoma were included .
METHODS	When the lesion was abutting on the thyroid capsule on 2D sonography , 3D sonography was performed .
METHODS	Three radiologists reviewed 3 data sets : 2D sonography , 3D sonography , and a combined set of both for tumor staging .
METHODS	The diagnostic performance , including sensitivity , specificity , positive predictive value , negative predictive value , and accuracy , for extrathyroidal extension was analyzed .
METHODS	Interobserver agreement of the 3 radiologists was assessed with values .
RESULTS	The overall accuracy rates for 2D sonography , 3D sonography , and the combined set in predicting extrathyroidal extension were 60.8 % , 66.2 % , and 67.9 % , respectively .
RESULTS	The accuracy of the combined set was significantly higher than that of 2D sonography ( P = .016 ) .
RESULTS	The interobserver agreement of the 3 reviewers was fair ( = 0.33 ) for 2D sonography and moderate for 3D sonography ( = 0.46 ) and the combined set ( = 0.49 ) .
CONCLUSIONS	Adding 3D sonography to 2D sonography could improve the accuracy and interobserver agreement for predicting extrathyroidal extension of papillary thyroid carcinoma .

###26003273
OBJECTIVE	To compare corifollitropin alfa with recombinant FSH treatment in terms of the vital pregnancy rate in older patients undergoing IVF .
METHODS	Phase 3 randomized , double-blind , noninferiority trial .
METHODS	Multicenter trial .
METHODS	A total of 1,390 women aged 35-42 years .
METHODS	A single injection of 150 g of corifollitropin alfa or daily 300 IU of recombinant FSH for the first 7 days then daily recombinant FSH until three follicles reach 17 mm in size .
METHODS	Ganirelix was started on stimulation day 5 up to and including the day of recombinant hCG administration .
METHODS	If available , two good quality embryos were transferred on day 3 .
METHODS	Vital pregnancy rate ( PR ) , number of oocytes , and live birth rate .
RESULTS	Vital PRs per started cycle were 23.9 % in the corifollitropin alfa group and 26.9 % in the recombinant FSH group , with an estimated difference ( 95 % confidence interval ) of -3.0 % ( -7.4 to 1.4 ) .
RESULTS	The mean ( SD ) number of recovered oocytes per started cycle was 10.7 ( 7.2 ) and 10.3 ( 6.8 ) in the corifollitropin alfa and the recombinant FSH groups , respectively , with an estimated difference of 0.5 ( -0.2 to 1.2 ) .
RESULTS	The live birth rates per started cycle were 21.3 % in the corifollitropin alfa group and 23.4 % in the recombinant FSH group , with an estimated difference ( 95 % confidence interval ) -2.3 % ( -6.5 to 1.9 ) .
RESULTS	The incidence of serious adverse events was 0.4 % versus 2.7 % in the corifollitropin alfa and recombinant FSH groups , respectively , and of ovarian hyperstimulation syndrome ( OHSS ; all grades ) was 1.7 % in both groups .
CONCLUSIONS	Treatment with corifollitropin alfa was proven noninferior to daily recombinant FSH with respect to vital PRs , number of oocytes retrieved , and live birth rates , and was generally well tolerated .
BACKGROUND	NCT01144416 .

###24681761
BACKGROUND	Recent reviews suggest Web-based interventions are promising approaches for weight management but they identify difficulties with suboptimal usage .
BACKGROUND	The literature suggests that offering some degree of human support to website users may boost usage and outcomes .
OBJECTIVE	We disseminated the POWeR ( `` Positive Online Weight Reduction '' ) Web-based weight management intervention in a community setting .
OBJECTIVE	POWeR consisted of weekly online sessions that emphasized self-monitoring , goal-setting , and cognitive/behavioral strategies .
OBJECTIVE	Our primary outcome was intervention usage and we investigated whether this was enhanced by the addition of brief telephone coaching .
OBJECTIVE	We also explored group differences in short-term self-reported weight loss .
METHODS	Participants were recruited using a range of methods including targeted mailouts , advertisements in the local press , notices on organizational websites , and social media .
METHODS	A total of 786 adults were randomized at an individual level through an online procedure to ( 1 ) POWeR only ( n = 264 ) , ( 2 ) POWeR plus coaching ( n = 247 ) , or ( 3 ) a waiting list control group ( n = 275 ) .
METHODS	Those in the POWeR plus coaching arm were contacted at approximately 7 and 28 days after randomization for short coaching telephone calls aimed at promoting continued usage of the website .
METHODS	Website usage was tracked automatically .
METHODS	Weight was assessed by online self-report .
RESULTS	Of the 511 participants allocated to the two intervention groups , the median number of POWeR sessions completed was just one ( IQR 0-2 for POWeR only , IQR 0-3 for POWeR plus coach ) .
RESULTS	Nonetheless , a substantial minority completed at least the core three sessions of POWeR : 47 participants ( 17.8 % , 47/264 ) in the POWeR-only arm and 64 participants ( 25.9 % , 64/247 ) in the POWeR plus coaching arm .
RESULTS	Participants in the POWeR plus coaching group persisted with the intervention for longer and were 1.61 times more likely to complete the core three sessions than the POWeR-only group ( ( 2 ) 1 = 4.93 ; OR 1.61 , 95 % CI 1.06-2 .47 ; n = 511 ) .
RESULTS	An intention-to-treat analysis showed between-group differences in weight loss ( F2 ,782 = 12.421 , P < .001 ) .
RESULTS	Both intervention groups reported more weight loss than the waiting list control group .
RESULTS	Weight loss was slightly , but not significantly , greater in the POWeR plus coaching group .
RESULTS	A large proportion of participants assigned to POWeR plus coaching refused phone calls or were not contactable ( 57.9 % , 143/247 ) .
RESULTS	Exploratory analyses identified health and sociodemographic differences between those who did and did not engage in coaching when it was made available to them .
RESULTS	Users who engaged with coaching used the intervention more and lost more weight than those who did not .
CONCLUSIONS	In common with most Web-based intervention studies , usage of POWeR was suboptimal overall .
CONCLUSIONS	However , our findings suggest that supplementing Web-based weight management with brief human support could improve usage and outcomes in those who take it up .
BACKGROUND	International Standard Randomized Controlled Trial Number ( ISRCTN ) : 98176068 ; http://www.controlled-trials.com/ISRCTN98176068 ( Archived by WebCite at http://www.webcitation.org/6OKRjM2oy ) .

###25127090
BACKGROUND	Patients with Addison 's disease ( AD ) report impaired subjective health status ( SHS ) .
BACKGROUND	Since cortisol exhibits a robust circadian cycle that entrains other biological clocks , impaired SHS may be due to the noncircadian cortisol profile achieved with conventional glucocorticoid replacement .
BACKGROUND	Continuous subcutaneous hydrocortisone infusion ( CSHI ) reproduces a circadian cortisol profile , but its effects on SHS have not been objectively evaluated .
OBJECTIVE	The aim of this study was to determine the effect of CSHI on SHS in AD .
METHODS	This was a multicentre , double-blind , placebo-controlled trial of CSHI vs oral glucocorticoid therapy .
METHODS	Participants received in random order 4 weeks of : CSHI and oral placebo , and subcutaneous placebo and oral hydrocortisone , separated by a 2-week washout period .
METHODS	SHS was assessed using the Short-Form 36 ( SF-36 ) , General Health Questionnaire ( GHQ-28 ) , Fatigue Scale ( FS ) , Gastrointestinal Symptom Rating Scale ( GSRS ) ; and Addison 's Quality of Life Questionnaire ( AddiQoL ) .
METHODS	Participants were asked their ( blinded ) treatment preference .
METHODS	Twenty-four hour urine free cortisol ( UFC ) and diurnal salivary cortisol collections compared cortisol exposure during each treatment .
RESULTS	Ten participants completed the study .
RESULTS	Baseline SHS scores ( mean SE ) were consistent with mild impairment : SF-36 physical component summary 48.4 ( 2.4 ) , mental component summary 53.3 ( 3.0 ) ; GHQ-28 18.1 ( 3.3 ) ; GSRS 3.7 ( 1.6 ) , and AddiQoL 94.7 ( 3.7 ) .
RESULTS	FS was similar to other AD cohorts 13.5 ( 1.0 ) ( P = 0.82 ) .
RESULTS	UFC between treatments was not different ( P = 0.87 ) .
RESULTS	The salivary cortisol at 0800 h was higher during CSHI ( P = 0.03 ) , but not at any other time points measured .
RESULTS	There was no difference between the treatments in the SHS assessments .
RESULTS	Five participants preferred CSHI , four oral hydrocortisone , and one was uncertain .
CONCLUSIONS	Biochemical measurements indicate similar cortisol exposure during each treatment period , although a more circadian pattern was evident during CSHI .
CONCLUSIONS	CSHI does not improve SHS in AD with good baseline SHS .
CONCLUSIONS	This casts some doubt on the potential benefit of circadian cortisol delivery on SHS in AD .

###25273982
OBJECTIVE	To evaluate the role of bladder training during postoperative hospital stay in patients submitted to nerve-sparing radical hysterectomy , and to identify any clinical or surgical factor associated with postoperative bladder dysfunction .
METHODS	Parallel group randomized single institution trial , on gynaecologic malignancies patients conducted in Catholic University of Sacred Heart Rome , between April 2009 and November 2011 .
METHODS	Randomization was on 1:1 , using a block randomized computer-generated list .
METHODS	Patients underwent Querleu-Morrow type B2 or C1 radical hysterectomy .
METHODS	After 2 days from surgery , patients were randomized to perform or not bladder training ( scheduled clamping and unclamping of the trans-urethral catheter every three hours ) .
METHODS	Main outcome measures Necessity and duration of clean intermittent self catheterization .
RESULTS	Randomized participants were 111 women ( bladder training arm n = 55 ; control arm n = 56 ) .
RESULTS	A total of 22 women ( 19.8 % ) required clean intermittent self catheterization , equally distributed in the two arms .
RESULTS	At univariate analysis , only the type of radical hysterectomy was significantly associated with need of clean intermittent self catheterization ( type C1 vs. type B2 ; p = 0.013 ) .
RESULTS	At univariate analysis , duration of clean intermittent self-catheterization was not associated with age , BMI , type of hysterectomy and of neo-adjuvant treatment .
CONCLUSIONS	Functional bladder disfunctions are the most common long-term complications following radical hysterectomy .
CONCLUSIONS	Systematic postoperative bladder training following nerve-sparing radical hysterectomy does not influence the rate of urinary retention or re-admission for bladder catheterization .

###25633662
OBJECTIVE	To evaluate the efficacy and safety of empagliflozin/linagliptin in subjects with type 2 diabetes .
METHODS	Subjects not receiving antidiabetes therapy for 12 weeks were randomized to empagliflozin 25 mg/linagliptin 5 mg ( n = 137 ) , empagliflozin 10 mg/linagliptin 5 mg ( n = 136 ) , empagliflozin 25 mg ( n = 135 ) , empagliflozin 10 mg ( n = 134 ) , or linagliptin 5 mg ( n = 135 ) for 52 weeks .
METHODS	The primary end point was change from baseline in HbA1c at week 24 .
RESULTS	Mean HbA1c at baseline was 7.99-8 .05 % ( 64 mmol/mol ) .
RESULTS	At week 24 , adjusted mean ( SE ) changes from baseline in HbA1c with empagliflozin 25 mg/linagliptin 5 mg , empagliflozin 10 mg/linagliptin 5 mg , empagliflozin 25 mg , empagliflozin 10 mg , and linagliptin 5 mg were -1.08 ( 0.06 ) % ( -11.8 [ 0.7 ] mmol/mol ) , -1.24 ( 0.06 ) % ( -13.6 [ 0.7 ] mmol/mol ) , -0.95 ( 0.06 ) % ( -10.4 [ 0.7 ] mmol/mol ) , -0.83 ( 0.06 ) % ( -9.1 [ 0.7 ] mmol/mol ) , and -0.67 ( 0.06 ) % ( -7.3 [ 0.7 ] mmol/mol ) , respectively .
RESULTS	Reductions in HbA1c were significantly greater for empagliflozin 25 mg/linagliptin 5 mg compared with linagliptin 5 mg ( P < 0.001 ) but not compared with empagliflozin 25 mg and were significantly greater for empagliflozin 10 mg/linagliptin 5 mg compared with the individual components ( P < 0.001 for both ) .
RESULTS	At week 24 , 55.4 % , 62.3 % , 41.5 % , 38.8 % , and 32.3 % of subjects with baseline HbA1c 7 % ( 53 mmol/mol ) reached HbA1c < 7 % with empagliflozin 25 mg/linagliptin 5 mg , empagliflozin 10 mg/linagliptin 5 mg , empagliflozin 25 mg , empagliflozin 10 mg , and linagliptin 5 mg , respectively .
RESULTS	Efficacy was maintained at week 52 .
RESULTS	The proportion of subjects with adverse events ( AEs ) over 52 weeks was similar across groups ( 68.9-81 .5 % ) , with no confirmed hypoglycemic AEs .
CONCLUSIONS	Reductions from baseline in HbA1c with empagliflozin/linagliptin were significantly different versus linagliptin and empagliflozin 10 mg but not versus empagliflozin 25 mg .
CONCLUSIONS	Empagliflozin/linagliptin was well tolerated .

###25353194
OBJECTIVE	The aims of this study were to test the hypothesis that people with stroke who receive formal powered wheelchair skills training improve their wheelchair skills to a significantly greater extent than participants in a control group who do not and to explore the influence of spatial neglect .
METHODS	Seventeen participants with stroke ( including nine with spatial neglect ) were randomly allocated to intervention ( n = 9 ) or control ( n = 8 ) groups .
METHODS	Those in the intervention group received up to five 30-min training sessions based on the Wheelchair Skills Training Program 4.1 .
METHODS	The powered Wheelchair Skills Test version 4.1 was administered at baseline ( T1 ) and after training ( T2 ) .
RESULTS	A rank order analysis of covariance on the T2 Wheelchair Skills Test score , having adjusted for the T1 score , showed a significant effect caused by group ( P = 0.0001 ) .
RESULTS	A secondary analysis showed no significant effect caused by spatial neglect ( P = 0.923 ) .
CONCLUSIONS	People with stroke who receive formal powered wheelchair skills training improve their powered wheelchair skills to a significantly greater extent ( 30 % ) than participants who do not ( 0 % ) .
CONCLUSIONS	The extent of change was not affected by the presence of spatial neglect .
CONCLUSIONS	These findings have significance for the wheelchair provision process and the rehabilitation of people with stroke .

###25579414
OBJECTIVE	The aims of this paper are ( i ) to compare the excitability of visual cortex in migraine patients with healthy volunteers ; and ( ii ) if an abnormal excitability has been found , to modulate cortical excitability in migraine patients with transcranial direct current stimulation ( tDCS ) and observe their clinical and neurophysiological effects .
METHODS	The study was divided into two steps .
METHODS	A cross-sectional study ( step 1 ) was conducted to compare the cortical excitability of 23 migraineurs ( 11 with and 12 without aura ) on 11 healthy individuals .
METHODS	On step 2 , a randomized , double blinded , controlled pilot trial was carried on with 19 migraineurs , randomly divided into : experimental and control group .
METHODS	During 12 sessions , experimental and group received active tDCS to visual cortex and control group received sham tDCS .
METHODS	The headache diary was applied for a total of 90days ( before , during and after tDCS sessions ) .
METHODS	Phosphene threshold ( PT ) induced by transcranial magnetic stimulation was recorded to measure the excitability of the visual cortex before and after each session .
RESULTS	Step 1 showed higher level of cortical excitability between migraineurs when compared to healthy volunteers ; therefore , cathodal tDCS was applied over visual cortex in step 2 .
RESULTS	After tDCS application , a significant decrease was observed in a number of migraine attacks , painkiller intake and duration of each attack just in experimental group .
RESULTS	The analysis of PT indicated no difference in cortical excitability after tDCS .
CONCLUSIONS	Findings of the study suggested that inhibitory tDCS on visual cortex might be an alternative and non-pharmacological treatment for migraine prophylaxis .
CONCLUSIONS	However the clinical improvements of patients after tDCS treatment are not correlated with changes in cortical excitability .

###24460248
OBJECTIVE	To evaluate breast self examination ( BSE ) practice and the effect of a training program conducted by healthcare professionals on BSE .
METHODS	Women were randomized into control and test groups with both groups completing a questionnaire and three independent interviews where their BSE practices were evaluated .
RESULTS	In all , 39.5 % of the participants were previously provided information on BSE by healthcare professionals while 25.8 % had no knowledge of BSE prior to enrollment .
RESULTS	Compared to those informed about BSE through other means such as television , radio , and the internet , the scores of the first , second , and third visits were higher ( p < 0.05 ) in individuals who received BSE education from healthcare professionals and hospitals .
CONCLUSIONS	BSE training provided by healthcare professionals may increase early breast cancer diagnosis and treatment rates by improving BSE awareness and practice .

###24569485
BACKGROUND	This study aimed to assess the efficacy of early intensive diabetes therapy with either insulin plus metformin ( INS ) or triple oral therapy ( TOT ) with metformin , glyburide , and pioglitazone on glycemic control and A-cell function .
METHODS	Fifty-eight treatment-naive newly diagnosed patients with type 2 diabetes underwent a 3-month lead-in treatment period with insulin and metformin , then were randomized to INS or TOT for 6 years .
METHODS	- Cell function was measured using mixed-meal challenge test .
METHODS	- Cell function remained stable throughout the 6-year study in both groups , as measured by the C-peptide area under the curve ( AUC ; P = 0.13 ) , the AUC C-peptide/AUC glucose ( P = 0.9 ) , and by the disposition index ( P = 0.8 ) .
METHODS	Excellent glycemic control was maintained in both groups ( end-of-study hemoglobinA1c , 7.3 % [ SD , 1.7 % ] INS vs 6.4 % [ 1.4 % ] TOT ; P = 0.4 ) .
METHODS	There were 8 treatment failures ( confirmed hemoglobinA1c , 98 % ) in INS and 6 in TOT ( P = 0.93 ) .
METHODS	The predictors of treatment failure included higher fasting glucose ( P = 0.008 ) , fasting C-peptide ( P = 0.008 ) , systolic blood pressure ( P = 0.004 ) , and lower insulin sensitivity ( P = 0.04 ) at randomization .
CONCLUSIONS	Early intensive treatment at the time of type 2 diabetes diagnosis-initial short-term insulin treatment followed by either insulin-based or intensive oral hypoglycemic-based therapy-stabilizes - cell function for at least 6 years .
CONCLUSIONS	Treatment failure was independent of intervention and was associated with worse disease pathology at baseline .

###26112229
OBJECTIVE	To investigate the change in eating behavior and the factors related with the change among successful dieters ( maintained a weight loss of 5 % of original weight ) .
METHODS	Obese adult subjects ( 21 male , 55 female ) were randomized into three-year lifestyle intervention ( n = 59 ) and control groups ( n = 17 ) .
METHODS	Eating behavior ( cognitive restraint of eating , uncontrolled eating and emotional eating ) was evaluated by the TFEQ-18 and motivation to lose weight and tolerance to problems by a separate questionnaire .
METHODS	Weight , height and body mass index were measured .
RESULTS	Weight decreased more in the intervention group than in the control group ( 5.0 % vs 0.6 % , p = 0.027 ) .
RESULTS	Cognitive restraint increased twice as much in the intervention group compared to the control group ( 16.0 vs. 7.0 , p = 0.044 ) .
RESULTS	The increment in cognitive restraint was positively associated with weight loss and high baseline motivation and tolerance to problems .
RESULTS	Cognitive restraint increased in both successful ( n = 27 ) and unsuccessful dieters ( n = 32 ) , but only the successful dieters were able to decrease uncontrolled eating in the long term .
CONCLUSIONS	Our results showed that intensive lifestyle counseling improved cognitive restraint which was associated with enhanced weight loss among obese adults .
CONCLUSIONS	Successful dieters also showed a long-term improvement of uncontrolled eating .
CONCLUSIONS	Eating behavior should be evaluated and followed before and during lifestyle interventions in order to support the change , e.g. by finding methods to control eating at risk situations and strengthening motivation and tolerance to problems .

###26069137
OBJECTIVE	The aim of this study was to evaluate the effects of premedication with oral atenolol or enalapril , in combination with remifentanil under sevoflurane anesthesia , on intraoperative blood loss by achieving adequate deliberate hypotension ( DH ) during orthognathic surgery .
OBJECTIVE	Furthermore , we investigated the impact thereof on the amount of nitroglycerin ( NTG ) administered as an adjuvant agent .
METHODS	Seventy-three patients undergoing orthognathic surgery were randomly allocated into one of three groups : an angiotensin converting enzyme inhibitor group ( Group A , n = 24 ) with enalapril 10 mg , a blocker group ( Group B , n = 24 ) with atenolol 25 mg , or a control group ( Group C , n = 25 ) with placebo .
METHODS	All patients were premedicated orally 1 h before the induction of anesthesia .
METHODS	NTG was the only adjuvant agent used to achieve DH when mean arterial blood pressure ( MAP ) was not controlled , despite the administration of the maximum remifentanil dose ( 0.3 g kg min ) with sevoflurane .
RESULTS	Seventy-two patients completed the study .
RESULTS	Blood loss was significantly reduced in Group A , compared to Group C ( adjusted p = 0.045 ) .
RESULTS	Over the target range of MAP percentage during DH was significantly higher in Group C than in Groups A and B ( adjusted p-values = 0.007 and 0.006 , respectively ) .
RESULTS	The total amount of NTG administered was significantly less in Group A than Group C ( adjusted p = 0.015 ) .
CONCLUSIONS	Premedication with enalapril ( 10 mg ) combined with remifentanil under sevoflurane anesthesia attenuated blood loss and achieved satisfactory DH during orthognathic surgery .
CONCLUSIONS	Furthermore , the amount of NTG was reduced during the surgery .

###24722495
OBJECTIVE	To compare a peer leader ( PL ) versus a community health worker ( CHW ) telephone outreach intervention in sustaining improvements in HbA1c over 12 months after a 6-month diabetes self-management education ( DSME ) program .
METHODS	One hundred and sixteen Latino adults with type 2 diabetes were recruited from a federally qualified health center and randomized to ( 1 ) a 6-month DSME program followed by 12 months of weekly group sessions delivered by PLs with telephone outreach to those unable to attend or ( 2 ) a 6-month DSME program followed by 12 months of monthly telephone outreach delivered by CHWs .
METHODS	The primary outcome was HbA1c .
METHODS	Secondary outcomes were cardiovascular disease risk factors , diabetes distress , and diabetes social support .
METHODS	Assessments were conducted at baseline , 6 , 12 , and 18 months .
RESULTS	After DSME , the PL group achieved a reduction in mean HbA1c ( 8.2-7 .5 % or 66-58 mmol/mol , P < 0.0001 ) that was maintained at 18 months ( -0.6 % or -6.6 mmol/mol from baseline [ P = 0.009 ] ) .
RESULTS	The CHW group also showed a reduction in HbA1c ( 7.8 vs. 7.3 % or 62 vs. 56 mmol/mol , P = 0.0004 ) post-6 month DSME ; however , it was attenuated at 18 months ( -0.3 % or -3.3 mmol/mol from baseline , within-group P = 0.234 ) .
RESULTS	Only the PL group maintained improvements achieved in blood pressure at 18 months .
RESULTS	At the 18-month follow-up , both groups maintained improvements in waist circumference , diabetes support , and diabetes distress , with no significant differences between groups .
CONCLUSIONS	Both low-cost maintenance programs led by either a PL or a CHW maintained improvements in key patient-reported diabetes outcomes , but the PL intervention may have additional benefit in sustaining clinical improvements beyond 12 months .

###26093980
BACKGROUND	The provision of several doses of monovalent type 1 oral poliovirus vaccine ( mOPV1 ) and bivalent OPV1 and 3 ( bOPV ) vaccines through campaigns is essential to stop the circulation of remaining wild polioviruses .
BACKGROUND	Our study aimed to assess the shortening of intervals between campaigns with bOPV and mOPV1 and to assess the immunogenicity of bOPV in routine immunisation schedules .
METHODS	We did an open-label , non-inferiority , five-arm , randomised controlled trial in Bangladesh .
METHODS	We recruited healthy infants aged 6 weeks at 42 immunisation clinics and randomly assigned them ( with blocks of 15 , three per group ) to receive a short three-dose schedule of bOPV ( bOPV short ) or mOPV1 ( mOPV1 short ) with the first dose given at age 6 weeks , the second at age 8 weeks , and the third at age 10 weeks ; or to a standard three-dose schedule of bOPV ( bOPV standard ) or mOPV1 ( mOPV1 standard ) or trivalent OPV ( tOPV standard ) with the first dose given at age 6 weeks , the second at 10 weeks , and the third at age 14 weeks .
METHODS	The primary outcome was the proportion of infants with antibody seroconversion for type 1 , type 2 , and type 3 polioviruses .
METHODS	The primary , modified intention-to-treat analysis included all patients who had testable serum samples before and after receiving at least one OPV dose .
METHODS	We used a 10 % margin to establish non-inferiority for bOPV groups versus mOPV1 groups in seroconversion for type 1 poliovirus , and for bOPV1 short versus bOPV1 standard for types 1 and 3 .
METHODS	This trial is registered at ClinicalTrials.gov , number NCT01633216 , and is closed to new participants .
RESULTS	Between May 13 , 2012 , and Jan 21 , 2013 , we randomly assigned 1000 infants to our study groups .
RESULTS	927 completed all study visits and were included in the primary analysis .
RESULTS	Seroconversion for type-1 poliovirus was recorded in 183 ( 98 % , 95 % CI 95-100 ) of 186 infants given bOPV short , 179 ( 97 % , 94-99 ) of 184 given bOPV standard , 180 ( 96 % , 92-98 ) of 188 given mOPV short , 178 ( 99 % , 97-100 ) of 179 given mOPV1 standard , and 175 ( 92 % , 87-96 ) of 190 given tOPV standard .
RESULTS	Seroconversion for type 2 was noted in 16 infants ( 9 % , 5-14 ) on bOPV short , 29 ( 16 % , 11-22 ) on bOPV standard , 19 ( 10 % , 7-15 ) on mOPV short , 33 ( 18 % , 13-25 ) on mOPV1 standard , and 182 ( 96 % , 92-98 ) on tOPV standard .
RESULTS	Seroconversion for type 3 was noted in 175 infants ( 94 % , 90-97 ) on bOPV short , 176 ( 96 % , 92-98 ) on bOPV standard , 18 ( 10 % , 6-15 ) on mOPV short , 25 ( 14 % , 10-20 ) on mOPV1 standard , and 167 ( 88 % , 83-92 ) on tOPV standard .
RESULTS	The short schedules for mOPV1 and bOPV elicited a non-inferior antibody response compared with the bOPV standard schedule .
RESULTS	104 adverse events were reported in 100 infants during follow up .
RESULTS	36 of these events needed admission to hospital ( 32 were pneumonia , two were vomiting or feeding disorders , one was septicaemia , and one was diarrhoea with severe malnutrition ) .
RESULTS	One of the infants admitted to hospital for pneumonia died 5 days after admission .
RESULTS	No adverse event was attributed to the vaccines .
CONCLUSIONS	Our trial showed that three doses of mOPV1 or bOPV with a short schedule of 2 week intervals between doses induces an immune response similar to that obtained with the standard schedule of giving doses at 4 week intervals .
CONCLUSIONS	These findings support the use of these vaccines in campaigns done at short intervals to rapidly increase population immunity against polioviruses to control outbreaks or prevent transmission in high-risk areas .
BACKGROUND	Centers for Disease Control and Prevention and UNICEF .

###24953249
OBJECTIVE	To study the immediate and short-term efficacy of adding transcutaneous electrical nerve stimulation ( TENS ) to standardized physical therapy on subacute spasticity within 6 months of spinal cord injury .
METHODS	Randomized controlled trial for 3 weeks .
METHODS	A university hospital .
METHODS	Subjects ( N = 16 ) with clinically determined spasticity were randomly assigned to either the experimental group ( n = 8 ) or the control group ( n = 8 ) .
METHODS	Sixty-minute sessions of TENS over the bilateral common peroneal nerves before 30 minutes of physical therapy for the experimental group and 30 minutes of physical therapy alone for the control group .
METHODS	All patients in both groups had access to standardized rehabilitation care .
METHODS	The composite spasticity score , which included 3 subscores ( ankle jerk , muscle tone , and ankle clonus scores ) , was used as the primary end point to assess plantar flexor spasticity .
METHODS	These subscores were designated as secondary end points .
METHODS	Serial evaluations were made at baseline before study entry and immediately after the first and last sessions in both groups .
RESULTS	On analysis for immediate effects , there was a significant reduction only in the composite spasticity score ( mean difference , 1.75 ; 99 % confidence interval [ CI ] , 0.47-3 .03 ; P = .002 ) in the experimental group , but no significant reduction was observed in all outcome variables in the control group .
RESULTS	A significant difference in the composite spasticity score ( 1.63 ; 99 % CI , 0.14-3 .11 ; P = .006 ) was observed between the 2 groups .
RESULTS	After 15 sessions of treatment , a significant reduction was determined in the composite spasticity score ( 2.75 ; 99 % CI , 1.31-4 .19 ; P < .001 ) , the muscle tone score ( 1.75 ; 99 % CI , 0.16-3 .34 ; P = .006 ) , and the ankle clonus score ( 0.75 ; 99 % CI , 0.18-1 .32 ; P = .003 ) in the experimental group , whereas none of the outcome variables revealed a significant reduction in the control group .
RESULTS	The between-group difference was significant only for the composite spasticity score ( 2.13 ; 99 % CI , 0.59-3 .66 ; P = .001 ) and the muscle tone score ( 1.50 ; 99 % CI , 0.15-2 .85 ; P = .005 ) after 15 intervention sessions .
CONCLUSIONS	Addition of TENS to standardized physical therapy had synergistically antispastic action , providing more effective reduction of clinical spasticity .

###25832102
OBJECTIVE	To determine whether the immunogenicity of a single dose infant priming schedule of serogroup C meningococcal ( MenC ) conjugate vaccine is non-inferior to a two dose priming schedule when followed by a booster dose at age 12 months .
METHODS	Phase IV open label randomised controlled trial carried out from July 2010 until August 2013 SETTING : Four centres in the United Kingdom and one centre in Malta .
METHODS	Healthy infants aged 6-12 weeks followed up until age 24 months .
METHODS	In the priming phase of the trial 509 infants were randomised in a 10:10:7:4 ratio into four groups to receive either a single MenC-cross reacting material 197 ( CRM ) dose at 3 months ; two doses of MenC-CRM at 3 and 4 months ; a single MenC-polysaccharide-tetanus toxoid ( TT ) dose at 3 months ; or no MenC doses , respectively .
METHODS	Haemophilus influenzae type b ( Hib ) - MenC-TT vaccine was administered to all infants at 12 months of age .
METHODS	All infants also received the nationally routinely recommended vaccines .
METHODS	Blood samples were taken at age 5 , 12 , 13 , and 24 months .
METHODS	MenC serum bactericidal antibody assay with rabbit complement ( rSBA ) one month after the Hib-MenC-TT vaccine .
METHODS	Non-inferiority was met if the lower 95 % confidence limit of the difference in the mean log10 MenC rSBA between the single dose MenC-CRM and the two dose MenC-CRM groups was > -0.35 .
RESULTS	The primary objective was met : after a Hib-MenC-TT booster dose at 12 months of age the MenC rSBA geometric mean titres induced in infants primed with a single MenC-CRM dose were not inferior to those induced in participants primed with two MenC-CRM doses in infancy ( 660 ( 95 % confidence interval 498 to 876 ) v 295 ( 220 to 398 ) ) with a corresponding difference in the mean log10 MenC rSBA of 0.35 ( 0.17 to 0.53 ) that showed superiority of the single over the two dose schedule ) .
RESULTS	Exploration of differences between the priming schedules showed that one month after Hib-MenC-TT vaccination , MenC rSBA 1:8 was observed in > 96 % of participants previously primed with any of the MenC vaccine schedules in infancy and in 83 % of those who were not vaccinated against MenC in infancy .
RESULTS	The MenC rSBA geometric mean titres induced by the Hib-MenC-TT boost were significantly higher in children who were primed with one rather than two MenC-CRM doses in infancy .
RESULTS	Only priming with MenC-TT , however , induced robust MenC bactericidal antibody after the Hib-MenC-TT booster that persisted until 24 months of age .
CONCLUSIONS	MenC vaccination programmes with two MenC infant priming doses could be reduced to a single priming dose without reducing post-boost antibody titres .
CONCLUSIONS	When followed by a Hib-MenC-TT booster dose , infant priming with a single MenC-TT vaccine dose induces a more robust antibody response than one or two infant doses of MenC-CRM .
CONCLUSIONS	Bactericidal antibody induced by a single Hib-MenC-TT conjugate vaccine dose at 12 months of age ( that is , a toddler only schedule ) , without infant priming , is not well sustained at 24 months .
CONCLUSIONS	Because of rapid waning of MenC antibody , programmes using toddler only schedules will still need to rely on herd protection to protect infants and young children.Trial registration Eudract No : 2009-016579-31 ; NCT01129518 ; study ID : 2008_06 ( http://clinicaltrials.gov ) .

###25586864
OBJECTIVE	To evaluate skin irritation and patch adhesiveness of a new weekly low-dose levonorgestrel ( LNG ) and ethinyl estradiol ( EE ) contraceptive patch ( LNG/EE patch ) .
METHODS	This analysis was part of an open-label , parallel-group , multicenter , phase 3 study that randomized healthy women to the LNG/EE patch ( one patch weekly for three consecutive weeks , followed by a patch-free week for 13 cycles ) or to an oral contraceptive for six cycles followed by seven LNG/EE patch cycles .
METHODS	Participants selected patch application sites of abdomen , buttock or upper torso .
METHODS	Investigators rated patch adhesiveness and skin irritation using standardized scales .
METHODS	Participants rated skin irritation and itching daily using standardized scales and recorded patch fall-off on daily diary cards .
RESULTS	A total of 32,508 patches were applied ( n = 1273 ) .
RESULTS	At the five clinic visits in which investigators rated the patches , they rated adhesiveness = 0 ( no lift ) for 84 % of participants and skin irritation = absent/mild for 97 % of patches .
RESULTS	Participants reported that 2-3 .7 % of patches fell off and rated skin irritation as absent or mild for 92 - 95 % of patches , according to site .
CONCLUSIONS	Investigator - and participant-rated assessments of LNG/EE patch adhesiveness and irritation demonstrated a low incidence of patch detachment , skin irritation and pruritus .
CONCLUSIONS	This secondary analysis of a phase 3 clinical trial of a new weekly low-dose LNG and EE contraceptive patch , which used assessment by both investigators and participants , observed a low incidence of skin irritation , pruritus and patch detachment .

###24747090
OBJECTIVE	We examine the role of body mass index in the assessment of prostate cancer risk .
METHODS	A total of 3,258 participants who underwent biopsy ( including 1,902 men with a diagnosis of prostate cancer ) were identified from the Selenium and Vitamin E Cancer Prevention Trial .
METHODS	The associations of body mass index with prostate cancer and high grade prostate cancer were examined using logistic regression , adjusting for age , race , body mass index adjusted prostate specific antigen , digital rectal examination , family history of prostate cancer , biopsy history , prostate specific antigen velocity , and time between study entry and the last biopsy .
METHODS	The prediction models were compared with our previously developed body mass index adjusted Prostate Cancer Prevention Trial prostate cancer risk calculator .
RESULTS	Of the study subjects 49.1 % were overweight and 29.3 % were obese .
RESULTS	After adjustment , among men without a known family history of prostate cancer , increased body mass index was not associated with a higher risk of prostate cancer ( per one-unit increase in logBMI OR 0.83 , p = 0.54 ) but was significantly associated with a higher risk of high grade prostate cancer ( ieGleason score 7 or greater prostate cancer ) ( OR 2.31 , p = 0.03 ) .
RESULTS	For men with a known family history of prostate cancer the risks of prostate cancer and high grade prostate cancer increased rapidly as body mass index increased ( prostate cancer OR 3.73 , p = 0.02 ; high grade prostate cancer OR 7.95 , p = 0.002 ) .
RESULTS	The previously developed risk calculator generally underestimated the risks of prostate cancer and high grade prostate cancer .
CONCLUSIONS	Body mass index provided independently predictive information regarding the risks of prostate cancer and high grade prostate cancer after adjusting for other risk factors .
CONCLUSIONS	Body mass index , especially in men with a known family history of prostate cancer , should be considered for inclusion in any clinical assessment of prostate cancer risk and recommendations regarding prostate biopsy .

###25249789
BACKGROUND	Fast track recovery is a care process goal after cardiac surgery .
BACKGROUND	Intraoperative anesthetic depth may impact recovery , but the impact of brain monitoring on time to extubation and intensive care unit ( ICU ) length of stay after cardiac surgery has not been extensively studied .
BACKGROUND	Our goal was to determine if BIS-guided anesthesia improves time to extubation compared to MAC-guided anesthesia in a cardiac surgery population .
METHODS	In this secondary outcome analysis of a randomized controlled study , we analyzed 294 patients undergoing elective coronary bypass grafting , valve replacements , and bypass plus valve replacements at a single tertiary referral center between February 1 , 2009 and April 30 , 2010 .
METHODS	We analyzed cardiac surgery patients that had been randomized to BIS-guided anesthesia alerts ( n = 131 ) or MAC-guided anesthesia alerts ( n = 163 ) .
METHODS	The primary outcome measure was time to extubation in the BIS-guided and anesthetic concentration-guided groups .
METHODS	Secondary outcomes were length of stay in the ICU and total postoperative hospital length of stay .
RESULTS	Valid extubation time data were available for 247 of 294 patients .
RESULTS	The median [ IQR ] time to extubation was 307 [ 215 to 771 ] minutes in the BIS group and 323 [ 196 to 730 ] minutes in the anesthetic concentration group ( p = 0.61 ) .
RESULTS	The median [ IQR ] ICU length of stay was 54 [ 29 to 97 ] hours versus 70 [ 44 to 99 ] hours ( p = 0.11 ) .
RESULTS	In terms of postoperative hospital length of stay , there was no difference between the groups with median [ IQR ] times of 6 [ 5-8 ] days ( p = 0.69 ) in each group .
CONCLUSIONS	The use of intraoperative BIS monitoring during cardiac surgery did not change time to extubation , ICU length of stay or hospital length of stay .
CONCLUSIONS	Data regarding BIS monitoring and recovery in an exclusively cardiac surgery population are consistent with recent effectiveness studies in the general surgical population .
BACKGROUND	ClinicalTrials.gov number NCT00689091 .

###24507481
BACKGROUND	Behavioral and psychological symptoms of dementia ( BPSD ) are often considered to be the greatest challenge in dementia care , leading to increased healthcare costs , caregiver burden , and placement into care facilities .
BACKGROUND	With potential for pharmacological intervention to exacerbate behaviors or even lead to mortality , the development and rigorous testing of non-pharmacological interventions is vital .
BACKGROUND	A pilot of the Tailored Activities Program ( TAP ) for reducing problem behaviors in people with dementia was conducted in the United States with promising results .
BACKGROUND	This randomized trial will investigate the effectiveness of TAP for reducing the burden of BPSD on persons with dementia and family caregivers within an Australian population .
BACKGROUND	This trial will also examine the cost-effectiveness and willingness to pay for TAP compared with a control group .
METHODS	This randomized trial aims to recruit 180 participant dyads of a person with dementia and their caregivers .
METHODS	Participants will have a diagnosis of dementia , exhibit behaviors as scored by the Neuropsychiatric Inventory , and the caregiver must have at least 7 h per week contact .
METHODS	Participants will be randomly allocated to intervention ( TAP ) or control ( phone-based education sessions ) groups , both provided by a trained occupational therapist .
METHODS	Primary outcome measure will be the revised Neuropsychiatric Inventory - Clinician rating scale ( NPI-C ) to measure BPSD exhibited by the person with dementia .
CONCLUSIONS	This trial investigates the effectiveness and cost-effectiveness of TAP within an Australian population .
CONCLUSIONS	Results will address a significant gap in the current Australian community-support base for people living with dementia and their caregivers .

###24717254
BACKGROUND	Armodafinil is a medication used to treat excessive sleepiness in individuals with shift work disorder ( SWD ) .
BACKGROUND	In the present study , we investigate whether armodafinil can normalize nocturnal sleepiness in a group of typical SWD patients .
METHODS	Participants were 12 night workers ( aged 33.8 8.57 years , 7 female subjects ) with excessive sleepiness ( 10 on the Epworth Sleepiness Scale ; mean , 14.8 3.16 ) , meeting the International Classification of Sleep Disorders , Second Edition criteria for SWD , with no other sleep or medical disorders verified by polysomnogram .
METHODS	The multiple sleep latency test ( MSLT ) was not used as an entry criteria .
METHODS	Armodafinil was administered at 10:30 pm in a randomized , double-blind , placebo-controlled , crossover design with experimental nights separated by 1 week .
METHODS	Primary end point was the MSLT , with naps at 1:30 , 3:30 , 5:30 , and 7:30 am .
METHODS	Other study measures included a sleepiness-alertness visual analog scale administered before each nap , and 2 computer-based performance tests evaluating attention and memory .
RESULTS	Subjects with SWD had a mean MSLT of 5.3 3.25 minutes , indicating a mean level of pathological sleepiness .
RESULTS	Armodafinil significantly improved MSLT score to 11.1 4.79 minutes ( P = 0.006 ) .
RESULTS	Subjective levels of alertness on the visual analog scale also improved ( P = 0.008 ) .
RESULTS	For performance , reaction time to central ( P = 0.006 ) and peripheral ( P = 0.003 ) stimuli and free recall memory ( P = 0.05 ) were also improved .
CONCLUSIONS	Armodafinil 150 mg administered at the beginning of a night shift normalizes nocturnal sleepiness in individuals with SWD unselected for objective sleepiness .
CONCLUSIONS	Subjective measures of sleepiness and cognitive performance are also improved .
CONCLUSIONS	This suggests that armodafinil can improve levels of nocturnal alertness to within normal daytime levels in the majority of patients with SWD .

###25711326
OBJECTIVE	HIV-1 transmitted drug resistance ( TDR ) in treatment-nave individuals is a well-described phenomenon .
OBJECTIVE	Baseline genotypic resistance testing is considered standard of care in most developed areas of the world .
OBJECTIVE	The aim of this analysis was to characterize HIV-1 TDR and the use of resistance testing in START trial participants .
METHODS	In the Strategic Timing of AntiRetroviral Treatment ( START ) trial , baseline genotypic resistance testing results were collected at study entry and analysed centrally to determine the prevalence of TDR in the study population .
METHODS	Resistance was based on a modified 2009 World Health Organization definition to reflect newer resistance mutations .
RESULTS	Baseline resistance testing was available in 1946 study participants .
RESULTS	Higher rates of testing occurred in Europe ( 86.7 % ) , the USA ( 81.3 % ) and Australia ( 89.9 % ) as compared with Asia ( 22.2 % ) , South America ( 1.8 % ) and Africa ( 0.1 % ) .
RESULTS	The overall prevalence of TDR was 10.1 % , more commonly to nonnucleoside reverse transcriptase inhibitors ( 4.5 % ) and nucleoside reverse transcriptase inhibitors ( 4 % ) compared with protease inhibitors ( 2.8 % ) .
RESULTS	The most frequent TDR mutations observed were M41L , D67N/G/E , T215F/Y/I / S/C/D / E/V/N , 219Q/E/N / R , K103N/S , and G190A/S/E in reverse transcriptase , and M46I/L and L90M in protease .
RESULTS	By country , the prevalence of TDR was highest in Australia ( 17.5 % ) , France ( 16.7 % ) , the USA ( 12.6 % ) and Spain ( 12.6 % ) .
RESULTS	No participant characteristics were identified as predictors of the presence of TDR .
CONCLUSIONS	START participants enrolled in resource-rich areas of the world were more likely to have baseline resistance testing .
CONCLUSIONS	In Europe , the USA and Australia , TDR prevalence rates varied by country .

###24319038
OBJECTIVE	To assess the efficacy of epidural motor cortex stimulation ( MCS ) on dystonia , spasticity , pain , and quality of life in patients with dystonia secondary to a focal basal ganglia ( BG ) lesion .
METHODS	In this double-blind , crossover , multicenter study , 5 patients with dystonia secondary to a focal BG lesion were included .
METHODS	Two quadripolar leads were implanted epidurally over the primary motor ( M1 ) and premotor cortices , contralateral to the most dystonic side .
METHODS	The leads were placed parallel to the central sulcus .
METHODS	Only the posterior lead over M1 was activated in this study .
METHODS	The most lateral or medial contact of the lead ( depending on whether the dystonia predominated in the upper or lower limb ) was selected as the anode , and the other 3 as cathodes .
METHODS	One month postoperatively , patients were randomly assigned to on - or off-stimulation for 3 months each , with a 1-month washout between the 2 conditions .
METHODS	Voltage , frequency , and pulse width were fixed at 3.8 V , 40 Hz , and 60 s , respectively .
METHODS	Evaluations of dystonia ( Burke-Fahn-Marsden Scale ) , spasticity ( Ashworth score ) , pain intensity ( visual analog scale ) , and quality of life ( 36-Item Short Form Health Survey ) were performed before surgery and after each period of stimulation .
RESULTS	Burke-Fahn-Marsden Scale , Ashworth score , pain intensity , and quality of life were not statistically significantly modified by MCS .
CONCLUSIONS	Bipolar epidural MCS failed to improve any clinical feature in dystonia secondary to a focal BG lesion .
METHODS	This study provides Class I evidence that bipolar epidural MCS with the anode placed over the motor representation of the most affected limb failed to improve any clinical feature in dystonia secondary to a focal BG lesion .

###24318688
BACKGROUND	Intermittent normobaric hypoxia training , an alternative to altitude training for athletes , may be beneficial to treat overweight and obesity .
BACKGROUND	The purpose of this study is to investigate whether normobaric hypoxia training combined with low-caloric diet has the additive effect on weight loss compared with normoxia training in obese young adults .
METHODS	Twenty-two subjects ( age 17-25 years , body mass index > 27.5 kg/m ( 2 ) ) were recruited for a 4-week residential camp of weight loss with low caloric intake , and trained at 60-70 % maximal heart rate of aerobics and 40-50 % of maximal strength of training .
METHODS	They were randomly assigned to either a normobaric hypoxia ( HT , FiO2 = 16.4-14 .5 % ) or normoxia training group ( NT , FiO2 = 21 % ) , and subjects in HT and NT groups experienced weekly 16-h normoxia and 6-h hypoxia or 22-h normoxia training , respectively .
METHODS	Body composition , resting blood pressure ( BP ) and brachial-ankle pulse wave velocity ( baPWV ) were determined before and after the intervention .
RESULTS	Weight loss was found in HT ( -6.9 kg or -7.0 % , p < 0.01 ) and NT groups ( -4.3 kg or -4.2 % , p < 0.01 ) significantly , and the former lost more weight than the latter ( p < 0.01 ) .
RESULTS	Hypoxia training improved systolic BP ( -7.6 % ) and mean BP ( -7.1 % ) significantly ( p < 0.05 ) despite having no effect on baPWV .
CONCLUSIONS	Four weeks of normobaric hypoxia residential training with low caloric diet has an additive improvement on weight loss .
CONCLUSIONS	It seems that normobaric hypoxia training might be a promising method to treat obesity .

###25764960
OBJECTIVE	Determine the cost-effectiveness of extracellular matrix ( ECM ) relative to human fibroblast-derived dermal substitute ( HFDS ) on diabetic foot ulcer ( DFU ) wound closure .
METHODS	Outcomes data were obtained from a 12-week , randomised , clinical trial of adults aged 18 years or older diagnosed with type 1 or type 2 diabetes with a DFU .
METHODS	Patients were treated with either ECM or HFDS treatment .
METHODS	A two-state Markov model ( healed and unhealed ) with a 1-week cycle length was developed using wound-closure rates from the trial to estimate the number of closed-wound weeks and the expected DFU cost per patient .
METHODS	Results were recorded over 12 weeks to estimate the number of closed-wound weeks per treatment and the average cost to achieve epithelialisation ( primary outcome ) .
METHODS	The perspective of the analysis was that of the payer , specifically the Centers for Medicare and Medicaid Services .
METHODS	No cost discounting was performed because of the short duration of the study .
RESULTS	The study consisted of 26 patients , with 13 in each group .
RESULTS	In the ECM group , 10 wounds closed ( 77 % ) , with an average closure time of 36 days ; 11 wounds closed in the HFDS group ( 85 % ) , with an average closure time of 41 days .
RESULTS	There was no significant difference between these results ( p = 0.73 ) .
RESULTS	Over 12 weeks , the expected cost per DFU was $ 2522 ( 1634 ) for ECM and $ 3889 ( 2524 ) for HFDS .
RESULTS	Patients treated with HFDS incurred total treatment costs that were approximately 54 % higher than those treated with ECM .
RESULTS	Sensitivity analyses revealed that the total cost of care for two applications of HFDS was more costly than eight applications of ECM by approximately $ 500 ( 325 ) .
CONCLUSIONS	In patients with DFU , ECM yielded similar clinical outcomes to HFDS but at a lower cost .
CONCLUSIONS	Health-care providers should consider ECM as a cost-saving alternative to HFDS .
BACKGROUND	A.M. Gilligan , and C.R. Waycaster , are employees of Smith & Nephew Inc. . .
BACKGROUND	This study was funded by Smith & Nephew Inc. . .
BACKGROUND	A.L. Landsman , reports no conflicts of interest .

###24605793
OBJECTIVE	To better understand the relationship between efficacy and perampanel dose , integrated actual ( last ) dose data from three phase III trials and an extension study ( blinded Conversion Period ; open-label Maintenance Period ) were analyzed .
METHODS	Seizure frequency data were analyzed in patients who were randomized to and completed the 13-week Maintenance Period of the phase III studies on perampanel 8mg , and who received an actual ( last ) dose of 12mg during ( 1 ) the extension 16-week blinded Conversion Period or ( 2 ) weeks 1-13 of the extension Maintenance Period .
METHODS	Due to a treatment-by-region interaction ( p = 0.042 ) , analyses excluded patients from the Latin America region ( n = 162/1 ,480 ; 10.9 % of the treated cohort ) .
RESULTS	Of 372 patients randomized to 8mg in the phase III studies , 273 completed the Maintenance Period at 8mg and 267 entered the extension study .
RESULTS	In patients who then had an actual ( last ) dose of 12mg during the extension blinded Conversion Period ( n = 217 ) , median percent change in seizure frequency per 28days improved from -32.4 % ( 8mg , phase III Maintenance Period ) to -44.2 % ( 12mg , extension blinded Conversion Period ) ; 50 % responder rates increased slightly from 37.3 % to 42.9 % .
RESULTS	In patients who completed the phase III studies on 8mg and had an actual ( last ) dose of 12mg during weeks 1-13 of the extension Maintenance Period ( n = 181 ) , median percent change in seizure frequency per 28days improved from -34.1 % ( phase III Maintenance Period ) to -46.0 % ( weeks 1-13 extension Maintenance Period ) ; 50 % responder rates were 39.2 % and 46.4 % .
RESULTS	Seizure control remained substantially unchanged in patients who completed the phase III studies at 12mg and continued on that dose during the extension .
CONCLUSIONS	Increasing perampanel dose from 8 to 12mg can produce additional benefits in seizure control in at least some patients who tolerate the higher dose .

###24718568
BACKGROUND	Individualizing antiplatelet therapy after platelet function testing did not improve outcome after coronary stenting in the Assessment by a Double Randomization of a Conventional Antiplatelet Strategy Versus a Monitoring-Guided Strategy for Drug-Eluting Stent Implantation and of Treatment Interruption Versus Continuation One Year After Stenting ( ARCTIC ) study .
BACKGROUND	Whether results are different during the phase of secondary prevention starting after hospital discharge , when periprocedural events have been excluded , is unknown .
RESULTS	In ARCTIC , 2440 patients were randomized before coronary stenting to a strategy of platelet function monitoring ( VerifyNow P2Y12/aspirin point-of-care assay ) with drug adjustment in suboptimal responders to antiplatelet therapy or to a conventional strategy without monitoring and without drug or dose changes .
RESULTS	We performed a landmark analysis starting at the time of hospital discharge evaluating the primary end point of death , myocardial infarction , stent thrombosis , stroke , or urgent revascularization through 1 year .
RESULTS	After discharge , the primary end point occurred in 8.6 % of patients in the monitoring arm and 7.9 % in the conventional arm ( hazard ratio , 1.105 ; 95 % confidence interval , 0.835-1 .461 ; P = 0.48 ) .
RESULTS	Stent thrombosis or urgent revascularization occurred in 4.4 % and 4.5 % in the monitoring and conventional arms , respectively ( P = 0.99 ) .
RESULTS	There was no difference for any of the other ischemic end points .
RESULTS	Major bleeding event rates were 1.8 % in the monitoring arm and 2.8 % in the conventional arm ( P = 0.11 ) , whereas major or minor bleeding event rates were 2.3 % and 3.4 % , respectively ( P = 0.10 ) .
CONCLUSIONS	Detection of platelet hyper-reactivity by platelet function testing in patients undergoing coronary stenting with further therapeutic adjustment does not reduce ischemic recurrences after intervention .
CONCLUSIONS	On-treatment platelet hyperreactivity can not be considered as a risk factor requiring intervention for secondary prevention after percutaneous coronary revascularization .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00827411 .

###24397408
OBJECTIVE	Age-related sleep changes have been associated with altered hypothalamic-pituitary-adrenal axis reactivity and impaired feedback inhibition at the glucocorticoid ( GR ) and mineralocorticoid ( MR ) receptor level .
OBJECTIVE	To further investigate the specific role of this binary receptor system in the elderly , sleep electroencephalogram ( EEG ) effects of the MR antagonist spironolactone and GR antagonist mifepristone in old-aged men were compared in this pilot study .
METHODS	Old-aged healthy men ( n = 6 , 65-91 years ) were treated on three occasions in a single-blinded design in random order with mifepristone , spironolactone and placebo , respectively , and nocturnal sleep EEG was recorded .
RESULTS	Mifepristone led to increased wake time , decreased stage 2 and rapid eye movement ( REM ) sleep and prolonged REM sleep latency in the first half of the night , whereas spironolactone had no considerable effects on sleep EEG .
CONCLUSIONS	GR antagonism can potentiate age-related sleep pattern alterations and further support the role of impaired GR signaling in age-related changes in sleep architecture .

###24943851
BACKGROUND	Obesity often occurs co-morbid with chronic , non-cancer pain .
BACKGROUND	While behavioral treatments have proved effective for pain management and weight loss independently , integrated interventions are lacking .
BACKGROUND	The study Simultaneously Targeting Obesity and Pain ( STOP ) is a prospective , pragmatic , randomized controlled trial that aims to determine whether overweight/obese individuals with chronic pain who are randomized to receive an integrated treatment Simultaneously Targeting Obesity and Pain ( STOP ) will show more weight loss and greater reduction in pain intensity over a 6-month period and greater maintenance at 12months than those who receive standard care behavioral weight loss or standard care behavioral pain management .
BACKGROUND	We hypothesize that individuals randomized to receive the STOP treatment will demonstrate improved weight loss , pain reduction , and maintenance compared to standard care treatment approaches .
METHODS	Adults aged18 with a body mass index25 and who report persistent pain ( 4 out of 0-10 for > 6months ) will be recruited for treatment at the Health Behavior Research Lab at the University of the Sciences .
METHODS	After baseline assessments and goal setting , participants will be randomized to receive one of three treatments .
METHODS	Participants will receive eleven treatment sessions delivered during 1hour , weekly individual meetings with a clinic therapist .
METHODS	Follow-up will occur at 3 , 6 and 12-month time points ; assessments will include measures of weight and pain intensity ( primary outcomes ) .
METHODS	A mixed-method approach to evaluating study outcomes will include individual interviews with participants about their treatment experience .
METHODS	These interviews will be led by a research staffer who was not involved in study intervention or assessment using a semi-structured discussion guide .
CONCLUSIONS	This study fills an important gap in intervention research , evaluating best-practices for behavioral management of a highly prevalent co-morbidity that has sub-optimal outcomes with currently-implemented approaches .
CONCLUSIONS	STOP 's pragmatic focus builds upon treatments already in use in clinical practice .
CONCLUSIONS	Should STOP be found efficacious in achieving the dual outcomes of pain management and weight loss , such an approach could be integrated into practice with minimal additional cost or training .
BACKGROUND	Clinical Trials.gov NCT02100995 Date of Registration : March 2014 .

###26002004
OBJECTIVE	To compare the visual outcome of microincision ( 2.2 mm ) with standard ( 2.75 mm ) corneal incision phacoemulsification .
METHODS	In this prospective , randomized comparative study , patients with senile cataract and less than 1 diopter ( D ) of astigmatism were divided into two groups .
METHODS	Group 1 included patients undergoing phacoemulsification with 2.2 mm clear corneal incision and group 2 included those undergoing phacoemulsification with 2.75 mm incision .
METHODS	The steep axis measured on keratometry was marked preoperatively .
METHODS	Phacoemulsification was performed through clear corneal incision on this steep axis .
METHODS	Assessment of visual acuity ( distance and near ) , keratometry , keratometric cylinder , contrast sensitivity by Functional Acuity Contrast Test , and surgically induced astigmatism ( SIA ) was performed at 1 day , 1 week , and 1 , 3 , and 6 months .
RESULTS	Fifty eyes of 50 patients were included in the study ( 29 were male ) .
RESULTS	There were 25 patients in each group .
RESULTS	The mean ( SD ) SIA calculated by vector analysis method ( Holladay-Cravy-Koch ) using keratometry value , at the end of 6 months , was 0.54 ( 0.18 ) D and 0.58 ( 0.14 ) D in groups 1 and 2 , respectively ( p = 0.27 ) .
RESULTS	No significant differences were found in the distance and near uncorrected visual acuity , mean keratometry , keratometric cylinder , contrast sensitivity , and SIA at any follow-up visit between two groups .
CONCLUSIONS	In patients with less than 1 D astigmatism undergoing phacoemulsification , both 2.2-mm and 2.75-mm clear corneal incisions result in similar postoperative visual outcome in terms of SIA , keratometry , and contrast sensitivity .

###25867913
OBJECTIVE	To evaluate the safety and efficacy of the novel tenofovir prodrug , tenofovir alafenamide ( TAF ) , as part of the first protease inhibitor-based single-tablet regimen ( STR ) for initial treatment of HIV-1 infection .
METHODS	Antiretroviral therapy ( ART ) - naive adults with estimated glomerular filtration rate 70 mL/min were randomized 2:1 to receive the darunavir/cobicistat/emtricitabine / tenofovir alafenamide ( D/C/F / TAF ) STR ( TAF : N = 103 ) or darunavir + cobicistat + emtricitabine/tenofovir disoproxil fumarate ( TDF : N = 50 ) once daily with matched placebos for 48 weeks .
RESULTS	At week 24 , viral suppression ( HIV-1 RNA < 50 copies/mL ) rates were similar ( TAF 74.8 % vs. TDF 74.0 % ) .
RESULTS	At week 48 , rates were TAF 76.7 % vs. TDF 84.0 % ; the difference was driven by higher rate of discontinuations in TAF ( 6.8 % ) vs. TDF ( 2 % ) .
RESULTS	Among those with virologic failure , none developed resistance .
RESULTS	Most adverse events were of mild/moderate severity .
RESULTS	The mean change in serum creatinine from baseline at week 48 was 0.06 mg/dL ( 95 % confidence interval : 0.04 to 0.08 ) for TAF vs. 0.09 mg/dL ( 95 % confidence interval : 0.05 to 0.14 ) for TDF ( P = 0.053 ) .
RESULTS	The % change in retinol binding protein/Cr ratio was +9 ( TAF ) vs. +54 ( TDF ) , P = 0.003 ; the % change in urine -2 microglobulin/Cr ratio was -42.0 ( TAF ) vs. +2.3 ( TDF ) , P = 0.002 .
RESULTS	The % change in hip bone mineral density ( BMD ) was -0.84 ( TAF ) vs. -3.82 ( TDF ) , P < 0.001 and in spine BMD was -1.57 ( TAF ) vs. -3.62 ( TDF ) , P = 0.003 .
RESULTS	There were no fractures in either group .
CONCLUSIONS	The TAF arm had significantly improved renal and bone safety parameters : less proteinuria and less change in hip and spine BMD , consistent with results from a similarly designed study of the elvitegravir/C/F / TAF STR .
CONCLUSIONS	This D/C/F / TAF STR offers a promising option for initial HIV treatment , with the high barrier to resistance of darunavir , and the potential for improved long-term renal and bone safety with TAF .

###25913022
BACKGROUND	Therapeutic hypothermia is recommended for comatose adults after witnessed out-of-hospital cardiac arrest , but data about this intervention in children are limited .
METHODS	We conducted this trial of two targeted temperature interventions at 38 children 's hospitals involving children who remained unconscious after out-of-hospital cardiac arrest .
METHODS	Within 6 hours after the return of circulation , comatose patients who were older than 2 days and younger than 18 years of age were randomly assigned to therapeutic hypothermia ( target temperature , 33.0 C ) or therapeutic normothermia ( target temperature , 36.8 C ) .
METHODS	The primary efficacy outcome , survival at 12 months after cardiac arrest with a Vineland Adaptive Behavior Scales , second edition ( VABS-II ) , score of 70 or higher ( on a scale from 20 to 160 , with higher scores indicating better function ) , was evaluated among patients with a VABS-II score of at least 70 before cardiac arrest .
RESULTS	A total of 295 patients underwent randomization .
RESULTS	Among the 260 patients with data that could be evaluated and who had a VABS-II score of at least 70 before cardiac arrest , there was no significant difference in the primary outcome between the hypothermia group and the normothermia group ( 20 % vs. 12 % ; relative likelihood , 1.54 ; 95 % confidence interval [ CI ] , 0.86 to 2.76 ; P = 0.14 ) .
RESULTS	Among all the patients with data that could be evaluated , the change in the VABS-II score from baseline to 12 months was not significantly different ( P = 0.13 ) and 1-year survival was similar ( 38 % in the hypothermia group vs. 29 % in the normothermia group ; relative likelihood , 1.29 ; 95 % CI , 0.93 to 1.79 ; P = 0.13 ) .
RESULTS	The groups had similar incidences of infection and serious arrhythmias , as well as similar use of blood products and 28-day mortality .
CONCLUSIONS	In comatose children who survived out-of-hospital cardiac arrest , therapeutic hypothermia , as compared with therapeutic normothermia , did not confer a significant benefit in survival with a good functional outcome at 1 year .
CONCLUSIONS	( Funded by the National Heart , Lung , and Blood Institute and others ; THAPCA-OH ClinicalTrials.gov number , NCT00878644 . )

###25323620
BACKGROUND	Many patients with lung cancer are deconditioned with poor physical fitness .
BACKGROUND	Lung resection reduces physical fitness further , impairing the patient 's ability to function in daily life .
METHODS	We conducted a single-blind randomised controlled trial of high-intensity endurance and strength training ( 60min , three times a week , 20weeks ) , starting 5-7weeks after surgery .
METHODS	The control group received standard postoperative care .
METHODS	The primary outcome was the change in peak oxygen uptake measured directly during walking until exhaustion .
METHODS	Other outcomes included changes in pulmonary function , muscular strength by one-repetition maximum ( 1RM ) , total muscle mass measured by dual energy X-ray absorptiometry , daily physical functioning and quality of life ( QoL ) .
RESULTS	The intention-to-treat analysis of the 61 randomised patients showed that the exercise group had a greater increase in peak oxygen uptake ( 3.4 mL/kg/min between-group difference , p = 0.002 ) , carbon monoxide transfer factor ( Tlco ) ( 5.2 % predicted , p = 0.007 ) , 1RM leg press ( 29.5 kg , p < 0.001 ) , chair stand ( 2.1 times p < 0.001 ) , stair run ( 4.3 steps , p = 0.002 ) and total muscle mass ( 1.36 kg , p = 0.012 ) compared with the controls .
RESULTS	The meanSD QoL ( SF-36 ) physical component summary score was 51.85.5 and 43.311.3 ( p = 0.006 ) , and the mental component summary score was 55.55.3 and 46.614.0 ( p = 0.015 ) in the exercise and control groups , respectively .
CONCLUSIONS	In patients recently operated for lung cancer , high-intensity endurance and strength training was well tolerated and induced clinically significant improvements in peak oxygen uptake , Tlco , muscular strength , total muscle mass , functional fitness and QoL .
CONCLUSIONS	This study may provide a basis for exercise therapy after lung cancer surgery .
BACKGROUND	NCT01748981 .

###24520782
OBJECTIVE	To investigate the efficacy and mechanisms of Bawei Xilei Powder ( BXP ) in treating ulcerative colitis ( UC ) .
METHODS	Totally 103 patients with left hemicolon mild to moderate UC in the active phase at the outpatient clinics of West China Hospital from June 2009 to October 2010 were randomly assigned to the treatment group ( 55 cases ) and the control group ( 48 cases ) .
METHODS	Patients in the treatment group were treated with BXP ( adding 1 g in 60 mL worm boiled water ) and those in the control group received by 50 mg/60 mL hydrocortisone edema solution ( once every evening before sleep ) .
METHODS	The therapeutic course for all was 4 weeks .
METHODS	The disease activity degree ( Mayo scoring ) , endoscopic , and histologic manifestations were compared between post-and pre-treatment in the two groups .
METHODS	The expression of toll-like receptor-4 ( TLR4 ) , nuclear factor-kappaB ( NF-kappaB ) , and Occludin were detected .
RESULTS	The clinical remission rate and the response rate in the treatment group were 78.2 % and 89.1 % respectively , higher than those of the control group ( 58.3 % and 72.9 % , P < 0.05 ) .
RESULTS	The endoscopically mucosal healing rate was 50.9 % in the treatment group and 31.3 % in the control group ( P < 0.05 ) .
RESULTS	The histological remission rate and the effective rate in the treatment group were 32.7 % and 65.5 % respectively , but higher than those of the control group ( 27.1 % and 58.3 % , P > 0.05 ) .
RESULTS	The rate of adverse events was 3.8 % in the treatment ( occurred in 2 cases ) and 4.3 % in the control group ( occurred in 2 cases , P > 0.05 ) .
RESULTS	Compared with pre-treatment , the expression of TLR4 and NF-kappaB p65 significantly decreased ( P < 0.05 ) , while the expression of Occludin significantly increased ( P < 0.05 ) .
CONCLUSIONS	BXP was effective and safe in patients with active mild to moderate UC .
CONCLUSIONS	Its effects might be involved in regulating the expression of inflammatory factors and enhancing mucosa barrier functions .
CONCLUSIONS	ulcerative colitis ; Bawei Xilei Powder ; enema therapy

###24730361
OBJECTIVE	To evaluate the efficacy of oral sucrose combined with non-nutritive sucking for reducing pain associated with retinopathy of prematurity screening .
METHODS	This was a randomised controlled study of 64 infants undergoing eye examination for retinopathy of prematurity screening .
METHODS	Topical anaesthetic ( Proparacaine ; Alcaine ( ) drop 0.5 % : ALCON CANADA Inc. , Mississauga , Canada ) was applied 30 sec before the eye examination in all infants .
METHODS	The infants in intervention group ( Group 1 , n = 32 ) received 0.5 mL/kg of 24 % sucrose with a pacifier .
METHODS	The control group ( Group 2 , n = 32 ) received 0.5 mL/kg of sterile water with a pacifier .
RESULTS	The groups had similar gestational ages ( 28.5 2.8 weeks ) , mean birthweight ( 1304 466 g ) or corrected gestational age ( 35.4 3.7 weeks ) at examination .
RESULTS	The intervention group had a significantly lower mean Premature Infant Pain Profile score during examination of the first eye , following insertion of the speculum ( Group 1:13.7 2.1 vs. Group 2:16.4 1.8 , p = 0.001 ) .
CONCLUSIONS	Although sucrose combined with non-nutritive sucking modestly reduces pain scores during eye examinations , there is need to further studies to explore significant pain relief for infants undergoing retinopathy of prematurity screening .

###24604664
OBJECTIVE	High resolution three-dimensional ( 3D ) late gadolinium enhancement ( LGE ) imaging is performed with single R-wave gating to minimize lengthy acquisition durations .
OBJECTIVE	In patients with atrial fibrillation ( AF ) , heart rate variability results in variable magnetization recovery between sequence repeats , and image quality is often poor .
OBJECTIVE	In this study , we implemented and tested a dynamic inversion time ( dynamic-TI ) scheme designed to reduce sequence sensitivity to heart rate variations .
METHODS	An inversion-prepared 3D segmented gradient echo sequence was modified so that the TI varied automatically from beat-to-beat ( dynamic-TI ) based on the time since the last sequence repeat .
METHODS	3D LGE acquisitions were performed in 17 patients prior to radio frequency ablation of persistent AF both with and without dynamic-TI .
METHODS	Qualitative image quality scores , blood signal-to-ghosting ratios ( SGRs ) .
METHODS	and blood-myocardium contrast-to-ghosting ratios ( CGRs ) were compared .
RESULTS	Image quality scores were higher with dynamic-TI than without dynamic-TI ( 2.2 0.9 vs. 1.8 1.1 , P = 0.008 ) , as were blood-myocardium CGRs ( 13.8 7.6 vs. 8.3 6.1 , P = 0.003 ) and blood SGRs ( 19.6 8.5 vs. 13.1 8.0 , P = 0.003 ) .
CONCLUSIONS	The dynamic-TI algorithm improves image quality of 3D LGE imaging in this difficult patient population by reducing the sequence sensitivity to RR interval variations

###24976417
OBJECTIVE	Taking weight-loss supplements may create illusion of protection against weight gain and thereby loosen subsequent dietary self-control .
OBJECTIVE	The current study examined whether taking weight-loss supplement would increase food intake and further tested whether positive attitudes toward supplements would increase susceptibility to overeating .
METHODS	Participants were randomly assigned to take either a known placebo or a purported weight loss supplement ( actually , the same placebo ) .
METHODS	After supplement provision , participants ' actual food consumption at a reward buffet lunch was recorded .
RESULTS	Compared with controls , participants receiving a purported weight loss supplement ate more food at the reward buffet .
RESULTS	Perceived progress toward the goal of weight reduction mediated the connection between use of weight loss supplements and subsequent food consumption .
RESULTS	Participants with more positive attitudes toward weight loss supplements were more susceptible to the liberating effect of taking weight loss supplements on food intake .
CONCLUSIONS	Using weight loss supplements may produce unintended consequences on dietary self-regulation .
CONCLUSIONS	The public should pay more attention to the notion of psychological liberation when using weight loss supplements .

###25092484
BACKGROUND	Intensive lifestyle interventions have been successful in reducing type 2 diabetes incidence .
BACKGROUND	Whether intensive programmes requiring face-to-face contact , trained staff and access to facilities are feasible , on a larger scale , has been debated .
OBJECTIVE	The aim of this study is to determine the feasibility and efficacy of a lifestyle intervention for type 2 diabetes prevention in men using an assessor-blinded , parallel-group , randomised controlled trial .
OBJECTIVE	The ` Type 2 Diabetes PULSE ( Prevention Using LifeStyle Education ) Programme for Men ' is a 6-month , self-administered , gender-tailored lifestyle intervention , with a multicomponent approach ( weight loss , dietary modification , aerobic exercise and resistance training ) .
OBJECTIVE	Eligible men were aged 18-65 years , overweight/obese ( BMI 25-40 kgm ( -2 ) ) and at high-risk for type 2 diabetes ( score 12 , Australian diabetes risk tool ) .
OBJECTIVE	Men with diagnosed prediabetes were eligible , but those with type 1 and 2 diabetes were ineligible .
OBJECTIVE	Randomisation was stratified by age ( < 50 or 50 years ) and BMI category ( kgm ( -2 ) : 25-29 .9 ; 30-34 .9 ; 35-40 ) to the intervention or wait-list control group .
OBJECTIVE	Data are collected at study entry ( baseline ) , 3 and 6 months .
OBJECTIVE	The primary outcome is weight change at 6 months .
OBJECTIVE	Secondary outcomes include : fasting plasma glucose , HbA1C , waist circumference , body composition , blood pressure , diet quality , aerobic fitness , muscular fitness and physical activity .
OBJECTIVE	Generalised linear mixed models ( intention-to-treat ) will assess outcomes for treatment ( intervention vs. control ) , time ( baseline , 3 and 6-months ) and the treatment-by-time interaction .
CONCLUSIONS	The results will determine the efficacy of a type 2 diabetes prevention programme for men with potential for wide reach and dissemination .
BACKGROUND	Australian New Zealand Clinical Trials Registry ( ACTRN12612000721808 ) .

###24948695
OBJECTIVE	To assess the impact of rapid diagnostic tests on the diagnostic accuracy and treatment of malaria and non-severe fever in an Asian setting .
METHODS	Patient randomised trial in primary level clinics .
METHODS	Two areas of Afghanistan where Plasmodium vivax and Plasmodium falciparum are endemic ; one area with moderate transmission ( eastern region ) and one with low transmission ( northern region ) .
METHODS	5794 patients of all ages with suspected malaria enrolled by 80 clinicians in 22 clinics .
METHODS	Malaria rapid diagnostic tests were compared with clinical diagnosis where no parasite diagnostic test was available , longer established field microscopy , and recently introduced microscopy .
METHODS	Proportion of patients appropriately treated with an antimalarial , defined as patients with P vivax who received chloroquine , patients with P falciparum who received artemisinin based combination therapy , and patients with no malaria parasites who did not receive an antimalarial .
METHODS	Secondary outcomes included diagnostic test accuracy and the proportion of patients negative for malaria who received antibiotics and antimalarials .
RESULTS	In the low transmission area , comparing rapid diagnostic tests with clinical diagnosis , 65 % ( 212/325 ) versus 12 % ( 40/321 ) of febrile patients were appropriately treated for malaria ( adjusted odds ratio 92.7 , 95 % confidence interval 12.4 to 694.1 , P < 0.001 ) .
RESULTS	The proportion of patients who were negative for malaria and received an antibiotic was 57 % ( 185/325 ) in the rapid diagnostic test arm compared with 14 % ( 46/321 ) in the clinical diagnosis arm ( 16.9 , 3.8 to 75.4 , P < 0.001 ) .
RESULTS	In the comparison of rapid diagnostic test with microscopy in the moderate transmission area , 83.6 % ( 1696/2028 ) versus 76.3 % ( 1512/1983 ) of patients were appropriately treated for malaria ( 1.70 , 1.30 to 2.23 , P < 0.001 ) .
RESULTS	A higher proportion of P falciparum cases received appropriate treatment with artemisinin based combination therapy when malaria was diagnosed by rapid diagnostic test ( 82 % , 58/71 v 32 % , 24/76 ; 9.2 , 3.88 to 21.66 , P < 0.001 ) .
CONCLUSIONS	In South and central Asian regions of low to moderate malaria transmission where clinics lack capacity for diagnosis with rapid diagnostic tests or microscopy , the introduction of the tests should be considered to improve clinical care , reduce the overuse of antimalarials , and improve disease surveillance .

###26169304
OBJECTIVE	Many patients treated for primary hypothyroidism have an unexplained reduced quality of life ( QOL ) .
OBJECTIVE	We studied the relation between QOL and various parameters in treated hypothyroid patients .
METHODS	QOL analysis was done in 90 consecutive patients ( 77.8 % females ) treated for primary hypothyroidism .
METHODS	QOL was measured by the questionnaires Short-Form 36 , Hospital Anxiety and Depression Scale and MFI20 .
METHODS	Post hoc analysis was performed on the relation of QOL at baseline and BMI , thyroid hormones and other serum values .
METHODS	QOL in patients was also compared to the general population .
RESULTS	QOL was decreased compared to the general population .
RESULTS	We found an inverse relationship between QOL and BMI .
RESULTS	A relationship between QOL and serum thyroid parameters or auto-antibodies could not be found .
RESULTS	Higher sex hormone binding globulin ( SHBG ) levels corresponded with a better QOL , which is explained by the negative association of SHBG with body weight and BMI .
CONCLUSIONS	A decreased QOL in hypothyroid patients on thyroxine treatment is related to a higher body weight ( BMI ) .
CONCLUSIONS	Weight gain needs more attention in the treatment of hypothyroidism .

###24338119
OBJECTIVE	Pregnancy is associated with increased risk for thromboembolic events .
OBJECTIVE	Intermittent pneumatic compression ( IPC ) devices are the method of thromboprophylaxis in a nonpregnant population .
OBJECTIVE	The aim of this study was to examine the effects of IPC on markers of fibrinolysis during cesarean delivery .
METHODS	We conducted a randomized controlled trial from April 2009 to March 2010 of women undergoing scheduled elective cesarean delivery .
METHODS	Forty-nine women were randomized to IPCs or usual care .
METHODS	All participants had three blood samples obtained : ( 1 ) baseline , ( 2 ) 1 hour after randomization , and ( 3 ) 30 minutes after cesarean delivery .
METHODS	Tissue-type plasminogen activator ( tPA ) , urokinase-type plasminogen activator ( uPA ) , thrombin-antithrombin complex ( TAT ) , plasminogen activator inhibitor-1 ( PAI-1 ) , and plasminogen activator inhibitor-2 ( PAI-2 ) levels were analyzed in each sample using an enzyme-linked immunosorbent assay .
METHODS	Statistical analysis was performed using repeated measures two-way analysis of variance with = 0.05 .
RESULTS	There was a time-dependent change in tPA , uPA , and PAI-1 levels following delivery but no difference in TAT and PAI-2 levels with time .
RESULTS	There were no differences between women randomized to IPCs or usual care .
CONCLUSIONS	Markers of fibrinolysis were not significantly altered by IPCs in this study of low-risk pregnant women .
CONCLUSIONS	Further research regarding the mechanism and efficacy of IPCs in pregnant women is warranted .

###24722769
BACKGROUND	Despite extensive use of enteral ( EN ) and parenteral nutrition ( PN ) in intensive care unit ( ICU ) populations for 4 decades , evidence to support their efficacy is extremely limited .
METHODS	A prospective randomized trial was conducted evaluate the impact on outcomes of intensive medical nutrition therapy ( IMNT ; provision of > 75 % of estimated energy and protein needs per day via EN and adequate oral diet ) from diagnosis of acute lung injury ( ALI ) to hospital discharge compared with standard nutrition support care ( SNSC ; standard EN and ad lib feeding ) .
METHODS	The primary outcome was infections ; secondary outcomes included number of days on mechanical ventilation , in the ICU , and in the hospital and mortality .
RESULTS	Overall , 78 patients ( 40 IMNT and 38 SNSC ) were recruited .
RESULTS	No significant differences between groups for age , body mass index , disease severity , white blood cell count , glucose , C-reactive protein , energy or protein needs occurred .
RESULTS	The IMNT group received significantly higher percentage of estimated energy ( 84.7 % vs 55.4 % , P < .0001 ) and protein needs ( 76.1 vs 54.4 % , P < .0001 ) per day compared with SNSC .
RESULTS	No differences occurred in length of mechanical ventilation , hospital or ICU stay , or infections .
RESULTS	The trial was stopped early because of significantly greater hospital mortality in IMNT vs SNSC ( 40 % vs 16 % , P = .02 ) .
RESULTS	Cox proportional hazards models indicated the hazard of death in the IMNT group was 5.67 times higher ( P = .001 ) than in the SNSC group .
CONCLUSIONS	Provision of IMNT from ALI diagnosis to hospital discharge increases mortality .

###25631734
OBJECTIVE	The aim of this study was to compare the total medicament doses and recovery profiles of patients for whom Bispectral Analysis ( BIS ) monitor was used to monitor sedation .
METHODS	Thirty-four uncooperative paediatric patients aged 3-6 years who attended to the Department of Pediatric Dentistry for dental treatment were enrolled in the study .
METHODS	Patients were randomly divided into 2 groups of 17 patients each .
METHODS	Physiological variables including oxygen saturation , blood pressure and heart rate were recorded .
METHODS	In one group ( BIS-monitored group ) , drugs were administered to maintain patients ' BIS values between 60-70 , while the other group ( Non-BIS-monitored Group ) was not monitored using BIS .
METHODS	Data was evaluated by Chi-square , Mann Whitney U , Independent Samples t , Paired Samples t and Wilcoxon signed tests , with a p-value of < 0.05 considered to be statistically significant .
RESULTS	There was no significant difference in total anesthetic doses , incidence of adverse events or recovery profiles of patients between non - BIS-monitored and BIS-monitored groups ( p 0.05 ) .
RESULTS	However , distinct correlation was determined among mean values of UMSS and BIS values ( p < 0.05 ) .
CONCLUSIONS	BIS represents no advantage over the current commonly accepted methods for monitoring sedation depth in children .

###24461901
BACKGROUND	The effect of 2-adrenergic receptor ( ADRB2 ) polymorphisms on the treatment response to longacting bronchodilators in chronic obstructive pulmonary disease ( COPD ) is unclear .
BACKGROUND	We aimed to establish whether ADRB2 polymorphisms differentially affected COPD exacerbation outcomes in response to tiotropium versus salmeterol .
METHODS	We did a prespecified analysis of the ADRB2 polymorphisms Arg16Gly and Gln27Glu within the 1 year randomised , double-blind , double-dummy , parallel-group Prevention Of Exacerbations with Tiotropium in COPD ( POET-COPD ) trial , comparing the effects of treatment with tiotropium or salmeterol on exacerbations in 7376 patients with COPD .
METHODS	One blood sample was collected for pharmacogenetic testing from each patient who elected to participate in the substudy .
METHODS	Random assignment of patients to treatment groups was not stratified according to genotypes .
METHODS	Genomic DNA was extracted from whole-blood specimens and samples were genotyped for the two SNPs , rs1042713 ( Arg16Gly ) and rs1042714 ( Gln27Glu ) .
METHODS	All assays were done in technical duplicates and 10 % of samples that were randomly chosen were repeated as technical duplicates in a second independent genotyping process .
METHODS	Our primary endpoint was the risk of a first exacerbation of COPD based on time to first exacerbation data .
METHODS	An exacerbation of COPD was defined as the increase or new onset of more than one symptom of COPD ( cough , sputum , wheezing , dyspnoea , or chest tightness ) , with at least one of the symptoms lasting for 3 days or more and needing treatment with antibiotics or systemic glucocorticoids ( moderate exacerbations ) , or admission to hospital ( severe exacerbations ) .
METHODS	POET-COPD is registered with ClinicalTrials.gov , number NCT00563381 .
RESULTS	5125 patients gave informed consent for genotyping .
RESULTS	The distributions of ADRB2 genotypes were well matched among groups .
RESULTS	Polymorphisms at aminoacid 27 did not affect exacerbation outcomes .
RESULTS	In the salmeterol group , patients with Arg16Arg genotype had a significantly reduced exacerbation risk compared with patients with Arg16Gly ( p = 00130 ) and Gly16Gly ( p = 00018 ) genotypes ( proportion of patients with at least one exacerbation was 323 % in Arg16Arg , 398 % in Arg16Gly , and 421 % in Gly16Gly ) .
RESULTS	By contrast , exacerbation risk was not modified by polymorphisms at aminoacid 16 in the tiotropium group .
RESULTS	The effect of the Arg16Gly polymorphism on treatment response to salmeterol was dependent on the use of inhaled corticosteroids ( ICS ) .
RESULTS	In patients untreated with ICS at baseline , Arg16Gly and Arg16Arg genotypes were associated with significantly prolonged time to first exacerbation compared with Gly16Gly ( vs Arg16Gly p = 00164 ; Arg16Arg p = 00316 ; proportion of patients with at least one exacerbation was 283 % in Arg16Arg , 316 % in Arg16Gly , and 392 % in Gly16Gly ) , whereas in patients on ICS at baseline , only the Arg16Arg genotype was associated with significantly prolonged time to first exacerbation compared with Gly16Gly ( p = 00198 ; not Arg16Gly p = 064 ; proportion of patients with at least one exacerbation was 359 % in Arg16Arg , 467 % in Arg16Gly , and 448 % in Gly16Gly ) .
RESULTS	The respiratory disorders , in particular worsening of COPD , were the most common serious adverse events .
CONCLUSIONS	Patients with the Arg16Arg genotype had better exacerbation outcomes in response to salmeterol than Gly16Gly and Arg16Gly genotypes , suggesting a potential differential Arg16Gly genotype effect on treatment response to longacting - agonists ( LABAs ) .
CONCLUSIONS	However , the use of ADRB2 polymorphisms for predicting LABA treatment response is still limited and further prospective validation will be needed to advance the mechanistic understanding of - adrenergic polymorphisms and their association with clinical features of COPD .
BACKGROUND	Boehringer Ingelheim and Pfizer .

###24452619
OBJECTIVE	This prospective randomized study aimed to compare the safety and efficacy of the TVT-Secur ( TVT-S ) with the trans vaginal obturator tape ( TVT-O ) for the treatment of stress urinary incontinence .
METHODS	We set out to enroll 136 patients in our study .
METHODS	106 patients with stress urinary incontinence were randomized to either the TVT-S ( n = 56 ) or TVT-O ( n = 50 ) procedure .
METHODS	Patients were evaluated postoperatively at 2months and 1year .
METHODS	Our primary outcome was objective cure measured by the cough test .
METHODS	Secondary outcomes of subjective symptoms , questionnaires , pain scores , complications , and urodynamic studies were also included .
METHODS	Statistical analysis was by Chi-squared , Kruskal-Wallis , Wilcoxon , and Fisher 's exact tests as appropriate .
METHODS	P values of < 0.05 were considered significant .
RESULTS	Objective cure rates were better for TVT-O compared with TVT-S at 1year ( 86 % and 63 % respectively , p = 0.01 ) .
RESULTS	Subjective cure rates were 88 % for TVT-O and 63 % for TVT-S .
RESULTS	Quality of life scores through questionnaires improved in both groups and were not statistically different .
RESULTS	Initial post-operative groin pain was more prevalent in the TVT-O group ; however , this resolved quickly with time .
CONCLUSIONS	TVT-O was superior to TVT-S in the objective cure of stress urinary incontinence at 1-year follow-up .

###25487561
BACKGROUND	Changes in DNA methylation have been associated with traffic-related air pollution in observational studies , but the specific mechanisms and temporal dynamics therein have not been explored in a controlled study of asthmatics .
BACKGROUND	In this study , we investigate short-term effects of diesel exhaust inhalation on DNA methylation levels at CpG sites across the genome in circulating blood in asthmatics .
METHODS	A double-blind crossover study of filtered air and diesel exhaust exposures was performed on sixteen non-smoking asthmatic subjects .
METHODS	Blood samples were collected pre-exposure , and then 6 and 30hours post-exposure .
METHODS	Peripheral blood mononuclear cell DNA methylation was interrogated using the Illumina Infinium HumanMethylation450 Array .
METHODS	Exposure-related changes in DNA methylation were identified .
METHODS	In addition , CpG sites overlapping with Alu or LINE1 repetitive elements and candidate microRNA loci were also analyzed .
RESULTS	DNA methylation at 2827 CpG sites were affected by exposure to diesel exhaust but not filtered air ; these sites enriched for genes involved in protein kinase and NFkB pathways .
RESULTS	CpG sites with significant changes in response to diesel exhaust exposure primarily became less methylated , with a site residing within GSTP1 being among the significant hits .
RESULTS	Diesel exhaust-associated change was also found for CpG sites overlapping with Alu and LINE1 elements as well as for a site within miR-21 .
CONCLUSIONS	Short-term exposure to diesel exhaust resulted in DNA methylation changes at CpG sites residing in genes involved in inflammation and oxidative stress response , repetitive elements , and microRNA .
CONCLUSIONS	This provides plausibility for the role of DNA methylation in pathways by which airborne particulate matter impacts gene expression and offers support for including DNA methylation analysis in future efforts to understand the interactions between environmental exposures and biological systems .

###24393602
BACKGROUND	Psoriasis affecting sites such as the hands , feet and nails can be particularly difficult to treat .
BACKGROUND	There are limited data on the efficacy of biological agents to treat these specific localizations .
OBJECTIVE	This analysis of a phase 2 regimen-finding study evaluated the efficacy of secukinumab in subjects with moderate-to-severe psoriasis and non-pustular involvement of the hands , feet and/or nails .
METHODS	Subjects were randomized ( 1 : 2 : 2 : 1 ) to one of three subcutaneous secukinumab 150-mg induction regimens [ Single ( Week 0 ) , Monthly ( Weeks 0 , 4 , 8 ) , Early ( Weeks 0 , 1 , 2 , 4 ) ] or placebo .
METHODS	In the subgroup ( n = 131 ) with hand and/or foot psoriasis [ baseline 5-point hand/foot Investigator 's Global Assessment ( IGA ) score 2 ] , efficacy was assessed as percentage of subjects achieving an IGA response [ a score of 0 ( clear ) or 1 ( minimal ) and an improvement of 2 points on the 5-point hand/foot scale vs. baseline ] at Week 12 .
METHODS	In the subgroup ( n = 304 ) with fingernail psoriasis ( baseline composite score 1 ) , efficacy was assessed as mean percentage change from baseline to Week 12 in a composite score .
RESULTS	At Week 12 , a markedly higher percentage of subjects with hand and/or foot psoriasis achieved an IGA response with the Early regimen vs. placebo ( 54.3 % vs. 19.2 % , P = 0.005 ) .
RESULTS	The composite fingernail score improved with the Early and Monthly regimens , but worsened with placebo [ percentage mean change from baseline ( SE ) : -19.1 % ( 6.12 ) and -10.6 % ( 7.06 ) vs. 14.4 % ( 11.92 ) ; P = 0.010 vs. placebo for Early , P = 0.027 for Monthly ) .
RESULTS	Secukinumab was well tolerated .
CONCLUSIONS	Secukinumab demonstrated a beneficial effect on psoriasis of the hands/feet/nails in this short-term assessment .

###24401173
BACKGROUND	Postal questionnaires are simple and economical for collecting outcome data for randomised controlled trials ( RCTs ) but are prone to non-response .
BACKGROUND	In the RECORD trial ( a large pragmatic publicly funded RCT in UK ) non-responders were sent a reminder and another questionnaire at 1 year , of which 40 % were returned .
BACKGROUND	In subsequent years we investigated the effect of an advance telephone call to non-responders on responses rate to reminder questionnaires and the next questionnaire 4 months later .
METHODS	Non-responders to annual questionnaires were randomised to receive a telephone call from the trial office ahead of the reminder questionnaire in addition to the usual reminder schedule ( n = 390 ) or to a control group that received the usual reminder schedule only ( n = 363 ) .
METHODS	The primary outcome was response to the reminder questionnaire within 21 days ; secondary outcomes were response to a questionnaire 4 months later ; completeness of quality of life instruments ; and the number of participants declining further follow-up .
METHODS	Results are presented as odds ratios from a logistic regression intention-to-treat ( ITT ) analysis and then percentage difference and 95 % confidence intervals ( CI ) for both ITT and average treatment effect on the treated ( ATT ) analyses .
RESULTS	The proportions that responded were 67.8 % ( 265/390 ) in the intervention group compared to 62.5 % ( 227/363 ) in the control group .
RESULTS	The ITT estimate was a 5.4 % increase ( 95 % CI -1.4 to 12.2 ) .
RESULTS	Four months later percentages responding were 51.8 % ( 202 ) and 42.7 % ( 155 ) .
RESULTS	The ITT estimate was a 9.1 % increase ( 95 % CI 2.0 to 16.2 ) .
RESULTS	In the intervention group 12.3 % ( 48/390 ) of participants were not telephoned because questionnaires were returned before the scheduled telephone call .
RESULTS	ATT estimates adjusting for this were 6.2 % ( 95 % CI -1.6 to 14.0 ) and 10.4 % ( 95 % CI 2.2 to 18.5 ) , respectively .
CONCLUSIONS	The telephone call resulted in a slight increase in response to the reminder questionnaire , however at 4 months later the proportion in the telephoned group responding was greater .
CONCLUSIONS	This study suggests that pre-notification telephone calls may only be worthwhile if further questionnaires are to be sent out soon after reminder questionnaires .
BACKGROUND	Current Clinical Trials ISRCTN51647438 .

###24557112
BACKGROUND	Effective lung collapse of the nonventilated lung can facilitate thoracic surgery .
BACKGROUND	Previous studies showed that using a bronchial blocker could delay the time of lung collapse compared with using a double-lumen endotracheal tube .
BACKGROUND	We hypothesized that the use of nitrous oxide ( N2O ) in the inspired gas mixture during 2-lung ventilation would lead to clinically relevant improvement of lung collapse during subsequent 1-lung ventilation with a bronchial blocker .
METHODS	Fifty patients were randomized into 2 groups : N2O ( n = 26 ) or O2 ( n = 24 ) .
METHODS	The N2O group received a gas mixture of oxygen and N2O ( FIO2 = 0.5 ) , and the O2 group received 100 % oxygen until the start of 1-lung ventilation .
METHODS	Lung isolation was achieved with an Arndt wire-guided bronchial blocker ( Cook Critical Care , Bloomington , IN .
METHODS	After turning patients to the lateral decubitus position , the cuff of the bronchial blocker was inflated under fiberoptic bronchoscopy surveillance , and thereafter , the dependent lung was ventilated with 100 % oxygen during 1-lung ventilation in both groups .
METHODS	Surgeons blinded to the randomization evaluated the degree of lung collapse by using a verbal rating scale ( lung collapse scale , 0 = no collapse to 10 = complete collapse ) at 5 minutes after opening the pleura .
METHODS	Also , as secondary outcomes , lung collapse at 1 and 10 minutes were evaluated .
RESULTS	The score on the lung collapse scale in the N2O group was significantly higher compared with the O2 group at 5 minutes after opening the pleura ( 7 vs 5 , P < 0.001 , WMWodds = 7.3 , 95 % confidence interval ( CI ) , 6.0 to 9.0 ) .
RESULTS	It was also higher in the N2O group at 10 minutes ( 10 vs 7 , P < 0.001 , WMWodds = 10.1 , 95 % CI , 1.9-13 .3 ) .
RESULTS	The lung collapse scale between groups was not significant at 1 minute after opening the pleura ( 2 vs 2 , P = 0.76 , WMWodds = 1.1 , 95 % CI , 0.96-1 .2 ) .
RESULTS	None of the patients developed hypoxia ( SpO2 < 92 % ) during 1-lung ventilation .
CONCLUSIONS	Filling the lung with 50 % N2O before 1-lung ventilation facilitated lung collapse 5 minutes after opening the chest compared with 100 % oxygen when a bronchial blocker was used .
CONCLUSIONS	The N2O/O2 mixture ( FIO2 = 0.5 ) did not have a harmful effect on subsequent arterial oxygenation during 1-lung ventilation .

###24755126
OBJECTIVE	To compare the therapeutic warfarin and aspirin efficacies for treatments of atrial fibrillation ( AF ) complicated with stable coronary heart disease particularly in older Chinese patients .
METHODS	In our prospective study 101 patients with AF and stable coronary heart disease older than 80 years were randomized into two groups .
METHODS	One group ( n = 51 ) basically received 1.25 mg/day warfarin per os , followed by addition of 0.5 - 1.0 mg/day from day 3 - 5 if the international normalized ratio ( INR ) was initially < 1.5 and in order to achieve a maintained INR between 1.6 and 2.5 ( warfarin group ) .
METHODS	The second group ( n = 50 ) received 100 mg aspirin per day ( control group ) .
METHODS	All patients were medicated and monitored for a period of 2 years .
METHODS	The primary endpoint was the occurrence of ischemic stroke or systemic embolism , and the composite secondary endpoint was non-fatal myocardial infarction and all causes of death .
METHODS	For safety evaluation , the hemorrhage rates were recorded .
RESULTS	The warfarin medication was superior regarding the overall occurrence of ischemic stroke or systemic embolism as well as non-fatal myocardial infarction and all causes of death outcomes compared to aspirin administration during the 2 years of medication ( 17.6 % vs. 36.0 % , p = 0.03 ) , while there was no significant difference of mild ( 5 vs. 4 ) , severe ( 2 vs. 1 ) , and fatal ( 1 vs. 1 ) hemorrhage incidences between the warfarin and aspirin groups ( p > 0.05 ) .
CONCLUSIONS	Warfarin was found to be more efficacious than aspirin for an anticoagulation therapy of older Chinese patients with AF and stable coronary heart disease .

###24698652
BACKGROUND	A major disadvantage of photorefractive keratectomy is postoperative pain and discomfort .
BACKGROUND	This study aims to evaluate whether topical diclofenac 0.1 % therapy adds any extra benefit to systemic diclofenac in controlling pain after photorefractive keratectomy .
METHODS	Prospective randomized , double-masked clinical trial applied in the Khatam-al-Anbia Eye Hospital , Mashhad University of Medical Sciences , Mashhad , Iran .
METHODS	Sixty-eight individuals ( age range , 18-35 years ) having bilateral photorefractive keratectomy for myopic correction with or without astigmatism .
METHODS	All patients received 100mg of extended-release oral diclofenac two times ( 12-h interval ) before photorefractive keratectomy surgery .
METHODS	Postoperatively , patients were randomized into the case and control groups .
METHODS	Case group was administered the diclofenac 0.1 % drop , one drop 2h preoperatively and four times daily postoperatively for 3 days , whereas the control group was given artificial tears instead .
METHODS	Pain level , photophobia and functional activity were evaluated by the patient after operation .
RESULTS	Two days after surgery , no statistically significant difference in pain level was noted between both groups .
RESULTS	In addition , photophobia and functional activity was not different between the case and control groups .
RESULTS	Eyelid oedema and conjunctival injection levels were significantly higher in the control group ( P < 0.001 ) .
CONCLUSIONS	Administration of topical diclofenac to a standardized postoperative pain regime did not alleviate post-photorefractive keratectomy pain , although it is effective in local signs like eyelid oedema and conjunctival injection .
CONCLUSIONS	It can be concluded that oral diclofenac is sufficient in the management of post-photorefractive keratectomy pain and addition of the topical diclofenac is unnecessary .

###25308787
OBJECTIVE	To explore the benefit of rapid induction with intravitreal bevacizumab for neovascular age-related macular degeneration ( AMD ) .
METHODS	Single-institution prospective randomized pilot study .
METHODS	Patients with treatment-nave neovascular AMD were randomized 1:1:1 into 1 of 3 groups based on the induction sequence : ( 1 ) every 2 weeks for 3 consecutive injections ; ( 2 ) every 4 weeks for 3 consecutive injections ; and ( 3 ) immediate pro re nata ( prn ) after the first injection .
METHODS	Retinal angiomatous proliferation and polypoidal choroidal vasculopathy were excluded .
METHODS	Best-corrected visual acuity ( BCVA ) and central retinal thickness using optical coherence tomography ( OCT ) were measured at baseline and at each follow-up .
METHODS	After induction , bevacizumab was administered as needed based mainly on OCT. .
METHODS	Main outcome measure was mean initial fluid-free interval after induction .
METHODS	Secondary outcomes were mean improvement in BCVA and central retinal thickness .
RESULTS	Each group included 30 patients ( 30 eyes ) .
RESULTS	Mean initial fluid-free interval was 2.4 , 3.4 , and 3.5 months for biweekly induction , monthly induction , and immediate prn groups , respectively ( P = .03 ) .
RESULTS	Significance was lost when corrected for age and sex ( P = .073 ) .
RESULTS	Mean improvement in BCVA , central retinal thickness , and total number of injections were similar among the groups at 12 months .
RESULTS	Six eyes in the biweekly induction group developed subretinal fibrosis vs no eyes in the other 2 groups ( P = .003 ) .
CONCLUSIONS	Biweekly induction with intravitreal bevacizumab for treatment-nave neovascular AMD does not increase initial fluid-free interval or cause significant anatomic and functional benefit compared to monthly induction or immediate prn .
CONCLUSIONS	There is also the potential development of subretinal fibrosis with biweekly induction .

###24617598
METHODS	Double blind pre-test post-test control group design .
OBJECTIVE	To compare the isokinetic quadriceps torque , standardized stair-climbing task ( SSCT ) and pain during SSCT between subjects diagnosed with knee osteoarthritis pre and post kinesio tape ( KT ) application with and without tension .
BACKGROUND	Strength of the quadriceps and torque producing capability is frequently found to be compromised in knee osteoarthritis .
BACKGROUND	The efficacy of KT in improving isokinetic quadriceps torque in knee osteoarthritis is unknown , forming the basis for this study .
METHODS	Forty subjects were randomly allocated to either the experimental ( therapeutic KT with tension ) or control group ( sham KT without tension ) with the allocation being concealed .
METHODS	Pre and post test measurements of isokinetic quadriceps torque , SSCT and pain during SSCT were carried out by a blinded assessor .
RESULTS	A large effect size with significant improvements in the peak quadriceps torque ( concentric and eccentric at angular velocities of 90 per second and 120 per second ) , SSCT and pain were obtained in the experimental group when compared to the control group .
CONCLUSIONS	Application of therapeutic KT is effective in improving isokinetic quadriceps torque , SSCT and reducing pain in knee osteoarthritis .

###25122430
BACKGROUND	In the phase IV , open-label , single-arm study NCT01203917 , first-line gefitinib 250 mg/d was effective and well tolerated in Caucasian patients with epidermal growth factor receptor ( EGFR ) mutation-positive non-small-cell lung cancer ( previously published ) .
BACKGROUND	Here , we report EGFR mutation analyses of plasma-derived , circulating-free tumor DNA .
METHODS	Mandatory tumor and duplicate plasma ( 1 and 2 ) baseline samples were collected ( all screened patients ; n = 1060 ) .
METHODS	Preplanned , exploratory analyses included EGFR mutation ( and subtype ) status of tumor versus plasma and between plasma samples .
METHODS	Post hoc , exploratory analyses included efficacy by tumor and plasma EGFR mutation ( and subtype ) status .
RESULTS	Available baseline tumor samples were 1033 of 1060 ( 118 positive of 859 mutation status known ; mutation frequency , 13.7 % ) .
RESULTS	Available plasma 1 samples were 803 of 1060 ( 82 positive of 784 mutation status known ; mutation frequency , 10.5 % ) .
RESULTS	Mutation status concordance between 652 matched tumor and plasma 1 samples was 94.3 % ( 95 % confidence interval [ CI ] , 92.3-96 .0 ) ( comparable for mutation subtypes ) ; test sensitivity was 65.7 % ( 95 % CI , 55.8-74 .7 ) ; and test specificity was 99.8 % ( 95 % CI , 99.0-100 .0 ) .
RESULTS	Twelve patients of unknown tumor mutation status were subsequently identified as plasma mutation-positive .
RESULTS	Available plasma 2 samples were 803 of 1060 ( 65 positive of 224 mutation status-evaluable and - known ) .
RESULTS	Mutation status concordance between 224 matched duplicate plasma 1 and 2 samples was 96.9 % ( 95 % CI , 93.7-98 .7 ) .
RESULTS	Objective response rates are as follows : mutation-positive tumor , 70 % ( 95 % CI , 60.5-77 .7 ) ; mutation-positive tumor and plasma 1 , 76.9 % ( 95 % CI , 65.4-85 .5 ) ; and mutation-positive tumor and mutation-negative plasma 1 , 59.5 % ( 95 % CI , 43.5-73 .7 ) .
RESULTS	Median progression-free survival ( months ) was 9.7 ( 95 % CI , 8.5-11 .0 ; 61 events ) for mutation-positive tumor and 10.2 ( 95 % CI , 8.5-12 .5 ; 36 events ) for mutation-positive tumor and plasma 1 .
CONCLUSIONS	The high concordance , specificity , and sensitivity demonstrate that EGFR mutation status can be accurately assessed using circulating-free tumor DNA .
CONCLUSIONS	Although encouraging and suggesting that plasma is a suitable substitute for mutation analysis , tumor tissue should remain the preferred sample type when available .

###24396050
OBJECTIVE	To demonstrate proof of concept for a smart phone-empowered community health worker ( CHW ) model of care for breast health promotion , clinical breast examination ( CBE ) , and patient navigation in rural Bangladesh .
METHODS	This study was a randomized controlled trial ; July 1 to October 31 , 2012 , 30 CHWs conducted door-to-door interviews of women aged 25 and older in Khulna Division .
METHODS	Only women who disclosed a breast symptom were offered CBE .
METHODS	Arm A : smart phone with applications to guide interview , report data , show motivational video , and offer appointment for women with an abnormal CBE .
METHODS	Arm B : smart phone/applications identical to Arm A plus CHW had training in `` patient navigation '' to address potential barriers to seeking care .
METHODS	Arm C : control arm ( no smart phone ; same interview recorded on paper ) .
METHODS	Outcomes are presented as the `` adherence '' ( to advice regarding a clinic appointment ) for women with an abnormal CBE .
METHODS	This study was approved by Women 's College Hospital Research Ethics Board ( Toronto , Ontario , Canada ) and district government officials ( Khulna , Bangladesh ) .
METHODS	Funded by Grand Challenges Canada .
RESULTS	In 4 months , 22,337 women were interviewed ; < 1 % declined participation , and 556 women had an abnormal CBE .
RESULTS	Control group CHWs completed fewer interviews , had inferior data quality , and identified significantly fewer women with abnormal breast exams compared with CHWs in arms A and B. Arm B had the highest adherence .
CONCLUSIONS	CHWs guided by our smart phone applications were more efficient and effective in breast health promotion compared with the control group .
CONCLUSIONS	CHW `` navigators '' were most effective in encouraging women with an abnormal breast examination to adhere to advice regarding clinic attendance .

###24822238
OBJECTIVE	To evaluate the preemptive analgesia of ketoprofen in comparison with diclofenac after mandibular third molar surgery .
METHODS	This study was a double-blind , randomized clinical trial .
METHODS	Forty patients were randomized into two treatment groups ( each with 20 patients ) by using a series of random numbers : group A received ketoprofen 100 mg and group B received diclofenac 75 mg , all intramuscularly .
METHODS	Surgery was done 30 minutes after analgesic treatments .
METHODS	The durations of analgesia , pain intensity , analgesic consumption , and side effects were evaluated .
METHODS	The statistical analysis was done using the chi-square , Student t , Mann-Whitney U , and Log-Rank tests .
RESULTS	The duration of analgesia was longer in the ketoprofen group when compared with the diclofenac group .
RESULTS	The number of patients taking the first rescue analgesic at 6 hours was lower in the ketoprofen group in comparison with the diclofenac group .
RESULTS	Patients who received ketoprofen had lower pain intensity compared with patients who received diclofenac .
CONCLUSIONS	Intramuscular ketoprofen 100 mg is more effective than intramuscular diclofenac 75 mg after mandibular third molar extraction when used as a preemptive analgesic .

###24740371
BACKGROUND	The 29-item Multiple Sclerosis Impact Scale ( MSIS-29 ) was developed to examine the impact of multiple sclerosis ( MS ) on physical and psychological functioning from a patient 's perspective .
OBJECTIVE	To determine the responder definition ( RD ) of the MSIS-29 physical impact subscale ( PHYS ) in a group of patients with relapsing-remitting MS ( RRMS ) participating in a clinical trial .
METHODS	Data from the SELECT trial comparing daclizumab high-yield process with placebo in patients with RRMS were used .
METHODS	Physical function was evaluated in SELECT using three patient-reported outcomes measures and the Expanded Disability Status Scale ( EDSS ) .
METHODS	Anchor - and distribution-based methods were used to identify an RD for the MSIS-29 .
RESULTS	Results across the anchor-based approach suggested MSIS-29 PHYS RD values of 6.91 ( mean ) , 7.14 ( median ) and 7.50 ( mode ) .
RESULTS	Distribution-based RD estimates ranged from 6.24 to 10.40 .
RESULTS	An RD of 7.50 was selected as the most appropriate threshold for physical worsening based on corresponding changes in the EDSS ( primary anchor of interest ) .
CONCLUSIONS	These findings indicate that a 7.50 point worsening on the MSIS-29 PHYS is a reasonable and practical threshold for identifying patients with RRMS who have experienced a clinically significant change in the physical impact of MS.

###25225952
BACKGROUND	Fostering patients ' sense of meaning is an essential task for palliative care clinicians .
BACKGROUND	Few studies have reported the effects on nurses of a short-term training program aimed at improving skills to relieve feelings of meaninglessness in terminally ill cancer patients .
OBJECTIVE	The primary aim of this study was to determine the impact on nurses of a novel two-day education program focusing on care that addresses patients ' feelings of meaninglessness .
OBJECTIVE	Measured were impacts on nurses ' confidence , self-reported practice , attitudes toward caring for such patients , burnout , meaning of life , and knowledge .
METHODS	This study was a randomized controlled trial using the waiting list control .
METHODS	Intervention consisted of a two-day interactive education program .
METHODS	A total of 76 nurses randomly allocated to two groups completed the study .
METHODS	Outcome measures included confidence scale ; self-reported practice scale ; scales of nursing attitudes toward caring for patients who experience feelings of meaningless ( willingness to help , positive appraisal , helplessness , nurse-perceived value of being , and nurse-perceived value of patients ' inner power ) ; Maslach burnout scale , Functional Assessment of Chronic Illness Therapy-Spiritual , and knowledge scale .
RESULTS	There were significant intervention effects in nurse-reported confidence and nurse-perceived value of patients ' inner power .
RESULTS	Nurse-reported helplessness showed marginally significant improvement after intervention ( p = 0.067 ) .
RESULTS	No significant intervention effects were observed in the self-reported practice scale ; attitudes toward caring for patients ( willingness to help , positive appraisal , and nurse-perceived value of being ) ; burnout scale , meaning of life ; and knowledge score .
RESULTS	The percentages of nurses who evaluated this program as useful or very useful were 95 % ( understanding the conceptual framework ) and 85 % ( helping to learn how to provide care for patients feeling meaninglessness in clinical practice ) .
CONCLUSIONS	This short-term educational intervention had a significant beneficial effect on nurses ' confidence and modest effects on attitudes .

###25064437
OBJECTIVE	Peginterferon lambda-1a ( Lambda ) is a type-III interferon with similar antiviral activity to alfa interferons but with a diminished extrahepatic receptor distribution , reducing the risk for extrahepatic adverse events .
METHODS	This was a randomized , blinded , actively-controlled , multicentre phase 2b dose-ranging study in patients chronically infected with HCV genotypes 1-4 .
METHODS	Treatment-naive patients received Lambda ( 120/180/240 g ) or peginterferon alfa-2a ( alfa ; 180 g ) once-weekly with ribavirin for 24 ( genotypes [ GT ] 2,3 ) or 48 ( GT1 ,4 ) weeks .
RESULTS	Rates of undetectable HCV-RNA at week 12 ( complete early virologic response [ cEVR ] ; primary end point ) were significantly higher in GT1 ,4 patients receiving Lambda vs. alfa ( 170/304 , 56 % vs. 38/103 , 37 % ) ; with similar cEVR rates for GT2 ,3 ( 80/88 , 91 % vs. 26/30 , 87 % ) .
RESULTS	Rates of undetectable HCV-RNA at week 4 were significantly higher on 180 g ( 15/102 , 15 % GT1 ,4 ; 22/29 , 76 % GT2 ,3 ) and 240 g ( 17/104 , 16 % GT1 ,4 ; 20/30 , 67 % GT2 ,3 ) Lambda than alfa ( 6/103 , 6 % GT1 ,4 ; 9/30 , 30 % GT2 ,3 ) .
RESULTS	Sustained virologic responses ( post-treatment week 24 ) were comparable between Lambda and alfa for GT1 ,4 ( 37-46 % Lambda ; 37 % alfa ) and GT2 ,3 ( 60-76 % Lambda ; 53 % alfa ) .
RESULTS	Aminotransferase and/or bilirubin elevations were the primary dose-limiting abnormalities for Lambda ; a sponsor-mandated 240 to 180 g dose reduction was therefore implemented .
RESULTS	Serious adverse events were comparable ( 3-13 % Lambda ; 3-7 % alfa ) .
RESULTS	Grade 3-4 haemoglobin , neutrophil , and platelet reductions were lower on Lambda than alfa .
RESULTS	Among alfa patients , 28/133 ( 21 % ) had peginterferon and 31/133 ( 23 % ) had ribavirin dose reductions for haematologic abnormalities vs. 0/392 and 8/392 ( 2 % ) on Lambda .
RESULTS	Lambda demonstrated fewer musculoskeletal ( 16-28 % vs. 47-63 % ) and influenza-like events ( 8-23 % vs. 40-46 % ) than alfa .
CONCLUSIONS	Lambda was associated with improved or similar rates of virologic response with fewer extrahepatic adverse events than alfa in chronic HCV infection .

###25341147
OBJECTIVE	The purpose of this study is to compare the diagnostic performance and radiation exposure of flat-panel CT arthrography for cartilage defect detection in the ankle joint to standard MDCT arthrography , using gross anatomy and thermoluminescent dosimetry as reference standards .
METHODS	Ten cadaveric ankle specimens were obtained from individuals who had willed their bodies to science .
METHODS	Five milliliters of a mixture of diluted ioxaglate and saline were injected .
METHODS	Specimens were examined consecutively with the use of flat-panel CT and MDCT .
METHODS	Radiation doses of flat-panel CT and MDCT were recorded using thermoluminescent dosimeters .
METHODS	Flat-panel CT and MDCT arthrography examinations were blinded and randomly evaluated by two musculoskeletal radiologists in consensus .
METHODS	In each ankle specimen , eight cartilage areas were assessed separately : medial talar surface , medial talar trochlea , lateral talar trochlea , lateral talar surface , tibial malleolus , medial tibial pla-fond , lateral tibial plafond , and fibular malleolus .
METHODS	Findings at flat-panel CT and MDCT arthrography were compared with macroscopic assessments in 80 cartilage areas .
RESULTS	For the detection of cartilage lesions , flat-panel CT showed a sensitivity of 80 % , specificity of 98 % , and accuracy of 94 % , and MDCT arthrography showed a sensitivity of 55 % , specificity of 98 % , and accuracy of 88 % .
RESULTS	Flat-panel CT and MDCT arthrography showed almost perfect ( = 0.83 ) and substantial ( = 0.65 ) agreement , respectively , with anatomic examination .
RESULTS	Radiation dose was significantly lower for flat-panel CT ( mean , 2.1 mGy ; range , 1.1-3 .0 mGy ) than for MDCT ( mean , 47.2 mGy ; range , 39.3-53 .8 mGy ) ( p < 0.01 ) .
CONCLUSIONS	Flat-panel CT arthrography is accurate for detecting cartilage defects in the ankle joint and is an alternative to MDCT arthrography that may have better diagnostic performance and may permit the use of a lower radiation dose .

###25733628
BACKGROUND	Currently , early weight-loss predictions of long-term weight-loss success rely on fixed percent-weight-loss thresholds .
OBJECTIVE	The objective was to develop thresholds during the first 3 mo of intervention that include the influence of age , sex , baseline weight , percent weight loss , and deviations from expected weight to predict whether a participant is likely to lose 5 % or more body weight by year 1 .
METHODS	Data consisting of month 1 , 2 , 3 , and 12 treatment weights were obtained from the 2-y Preventing Obesity Using Novel Dietary Strategies ( POUNDS Lost ) intervention .
METHODS	Logistic regression models that included covariates of age , height , sex , baseline weight , target energy intake , percent weight loss , and deviation of actual weight from expected were developed for months 1 , 2 , and 3 that predicted the probability of losing < 5 % of body weight in 1 y. Receiver operating characteristic ( ROC ) curves , area under the curve ( AUC ) , and thresholds were calculated for each model .
METHODS	The AUC statistic quantified the ROC curve 's capacity to classify participants likely to lose < 5 % of their body weight at the end of 1 y.
METHODS	The models yielding the highest AUC were retained as optimal .
METHODS	For comparison with current practice , ROC curves relying solely on percent weight loss were also calculated .
RESULTS	Optimal models for months 1 , 2 , and 3 yielded ROC curves with AUCs of 0.68 ( 95 % CI : 0.63 , 0.74 ) , 0.75 ( 95 % CI : 0.71 , 0.81 ) , and 0.79 ( 95 % CI : 0.74 , 0.84 ) , respectively .
RESULTS	Percent weight loss alone was not better at identifying true positives than random chance ( AUC 0.50 ) .
CONCLUSIONS	The newly derived models provide a personalized prediction of long-term success from early weight-loss variables .
CONCLUSIONS	The predictions improve on existing fixed percent-weight-loss thresholds .
CONCLUSIONS	Future research is needed to explore model application for informing treatment approaches during early intervention .

###25878305
BACKGROUND	Previous studies have shown good clinical results in patients with midshaft clavicular fractures treated with reconstruction plate fixation or elastic stable intramedullary nailing .
BACKGROUND	The objective of this study was to compare these methods in terms of clinical and radiographic results .
METHODS	In this prospective , randomized controlled trial , fifty-nine patients with displaced midshaft clavicular fractures were randomly assigned to receive fixation with either a reconstruction plate ( thirty-three patients ) , known as the plate group , or elastic stable intramedullary nailing ( twenty-six patients ) , known as the nail group .
METHODS	The primary outcome was the six-month Disabilities of the Arm , Shoulder and Hand ( DASH ) score .
METHODS	The secondary outcomes included the Constant-Murley score , time to fracture union , residual shortening , level of postoperative pain , percentage of satisfied patients , and complication rates .
RESULTS	The mean six-month DASH score was 9.9 points in the plate group and 8.5 points in the nail group ( p = 0.329 ) .
RESULTS	Similarly , there were no differences in the twelve-month DASH and Constant-Murley scores .
RESULTS	Time to union was equivalent ( p = 0.352 ) between the groups at 16.8 weeks for the plate group and 15.9 weeks for the nail group , whereas the residual shortening was 0.4 cm greater in the plate group ( p = 0.032 ) .
RESULTS	The visual analog scale pain score and the satisfaction rate were similar between the groups .
RESULTS	Implant-related pain was more frequent in the nail group ( p = 0.035 ) .
RESULTS	There were no differences in terms of major complications .
CONCLUSIONS	Reconstruction plates and elastic stable intramedullary nailing yielded similar functional results , time to union , level of postoperative pain , and patient satisfaction rates .
CONCLUSIONS	Both methods were safe in terms of major complications .

###24882841
OBJECTIVE	To describe a feasibility study focused on a telemonitoring approach to self-managed kinesiotherapy sessions for the rehabilitation of hand function in patients with systemic sclerosis ( SSc ) and rheumatoid arthritis ( RA ) .
METHODS	Ten patients with SSc and 10 with RA were enrolled in a 3-month controlled trial ( approval no. 9751/2012 - Italian Department of Health ) to perform a home kinesiotherapy protocol , consisting of strengthening and mobility exercises , using a newly developed telemedicine system ( a portable device and the related telemonitoring infrastructure ) .
METHODS	A further 10 patients with SSc and 10 with RA were enrolled as controls to perform a similar home kinesiotherapy protocol with the aid of common daily-life objects .
METHODS	Both groups were evaluated at baseline and at followup , after 6 and 12 weeks .
METHODS	The primary outcome of the trial was hand function measured by Dreiser 's index ( Functional Index for Hand OA , FIHOA ) , Health Assessment Questionnaire ( HAQ ) , and the Hand Mobility in Scleroderma ( HAMIS ) test ( only for SSc ) .
RESULTS	Patients with SSc showed an improvement of FIHOA in both arms ( p < 0.01 ) but the HAQ ( p = 0.016 ) and the HAMIS test ( right hand p = 0.016 , left hand p = 0.075 ) improved significantly only in the experimental arm .
RESULTS	Patients with RA showed a statistically significant improvement of FIHOA ( p = 0.013 ) and HAQ ( p = 0.015 ) in the experimental arm , while patients in the control arm did not significantly improve .
RESULTS	However , no statistically significant differences in outcome measures between treatment methods were observed .
RESULTS	Withdrawals were higher in control arms ( SSc 20 % ; RA 30 % ) than in experimental arms ( SSc 10 % ; RA 10 % ) .
CONCLUSIONS	Telemonitoring of self-administered kinesiotherapy programs is a promising approach to the rehabilitation of hand functions in patients with rheumatic disease .

###25890808
OBJECTIVE	Mobile-bearing total knee arthroplasty ( TKA ) implants were developed as an alternative to fixed-bearing implants because of their theoretical advantages related to wear and range of motion .
OBJECTIVE	For all that , none of the short-term and medium-term studies published so far have reported a significant clinical improvement related to these mobile bearings .
OBJECTIVE	The goal of this study was to compare the outcomes of fixed and mobile bearings in the same type of TKA model after a longer follow-up .
METHODS	This series initially comprised 100 patients with a mean age of 73 years who were operated by a single surgeon .
METHODS	The patients were randomised to receive either a fixed bearing TKA implant or a mobile one ; their outcomes evaluated after a mean of 9 years ( 7.2-12 .2 ) follow-up .
METHODS	Twenty-two patients died before the final review , 15 were lost to follow-up and 2 were excluded .
METHODS	This resulted in 30 patients with a mobile-bearing knee and 31 with a fixed-bearing knee being available for analysis .
RESULTS	There were no significant clinical differences between the groups receiving a fixed or mobile bearing in terms of the range of motion , subjective outcomes or validated outcomes measured , such as the self-reported Oxford or the IKS .
RESULTS	Conversely , there was a significantly higher rate of osteolysis in the fixed-bearing group , but it was not clinically relevant .
CONCLUSIONS	This study , which has the longest published follow-up , confirms the results found in the seven randomised studies published up to now : there are no significant differences in the clinical outcomes between fixed-bearing and mobile-bearing inserts of the same TKA model .
CONCLUSIONS	Although the mobile bearing knees had a better radiographic appearance , this did not translate to better clinical outcomes .
CONCLUSIONS	In practice , the superiority of mobile bearings is solely theoretical .
METHODS	Prospective randomised study .

###25125505
OBJECTIVE	To examine whether a pistachio-rich diet reduces the prediabetes stage and improves its metabolic risk profile .
METHODS	Prediabetic subjects were recruited to participate in this Spanish randomized clinical trial between 20 September 2011 and 4 February 2013 .
METHODS	In a crossover manner , 54 subjects consumed two diets , each for 4 months : a pistachio-supplemented diet ( PD ) and a control diet ( CD ) .
METHODS	A 2-week washout period separated study periods .
METHODS	Diets were isocaloric and matched for protein , fiber , and saturated fatty acids .
METHODS	A total of 55 % of the CD calories came from carbohydrates and 30 % from fat , whereas for the PD , these percentages were 50 and 35 % , respectively ( including 57 g/day of pistachios ) .
RESULTS	Fasting glucose , insulin , and HOMA of insulin resistance decreased significantly after the PD compared with the CD .
RESULTS	Other cardiometabolic risk markers such as fibrinogen , oxidized LDL , and platelet factor 4 significantly decreased under the PD compared with the CD ( P < 0.05 ) , whereas glucagon-like peptide-1 increased .
RESULTS	Interleukin-6 mRNA and resistin gene expression decreased by 9 and 6 % , respectively , in lymphocytes after the pistachio intervention ( P < 0.05 , for PD vs. CD ) .
RESULTS	SLC2A4 expression increased by 69 % in CD ( P = 0.03 , for PD vs. CD ) .
RESULTS	Cellular glucose uptake by lymphocytes decreased by 78.78 % during the PD ( P = 0.01 , PD vs. CD ) .
CONCLUSIONS	Chronic pistachio consumption is emerging as a useful nutritional strategy for the prediabetic state .
CONCLUSIONS	Data suggest that pistachios have a glucose - and insulin-lowering effect , promote a healthier metabolic profile , and reverse certain metabolic deleterious consequences of prediabetes .

###24568110
OBJECTIVE	To determine the effect of food-toy enrichment combined with cage-behavior training on desirable behaviors in shelter dogs and adoption rates .
METHODS	Randomized controlled clinical trial .
METHODS	107 dogs .
METHODS	Dogs placed up for adoption in a municipal shelter were randomly assigned to either an experimental group ( n = 48 ) or control group ( 59 ) .
METHODS	Experimental group subjects were exposed to an environmental enrichment and training protocol consisting of twice-daily cage-behavior training and daily provision of a food-filled toy .
METHODS	Cage-behavior training included operant conditioning via positive reinforcement of desirable behaviors , including approaching the front of the cage , sitting or lying , and remaining quiet when approached .
METHODS	Behavioral observations were performed by a blinded observer in a scan-sampling technique on day 0 ( first day on adoption floor ) and again on day 3 for experimental ( n = 26 ) and control ( 32 ) dogs .
METHODS	Body posture , location in cage , and other behavioral parameters were recorded .
METHODS	Adoption information and behavioral observation data were compared between groups .
RESULTS	Compared with the control group , the experimental group had a significantly greater percentage of dogs with an increase in desirable behaviors of sitting or lying down ( 17/26 [ 65 % ] vs 7/32 [ 22 % ] ) and being quiet ( 9/26 [ 35 % ] vs 4/32 [ 13 % ] ) and a significantly greater percentage of dogs with a decrease in the undesirable behavior of jumping ( 15/26 [ 57 % ] vs 3/32 [ 9 % ] ) .
RESULTS	Location in cage , fearfulness , and eye contact were not significantly different between groups .
RESULTS	Survival analysis revealed no significant difference in adoption rates between groups .
CONCLUSIONS	Results suggested that enrichment programs improve desirable behaviors and decrease undesirable behavior in shelter dogs , which may enhance welfare .

###25693011
BACKGROUND	The investigational 9-valent viruslike particle vaccine against human papillomavirus ( HPV ) includes the HPV types in the quadrivalent HPV ( qHPV ) vaccine ( 6 , 11 , 16 , and 18 ) and five additional oncogenic types ( 31 , 33 , 45 , 52 , and 58 ) .
BACKGROUND	Here we present the results of a study of the efficacy and immunogenicity of the 9vHPV vaccine in women 16 to 26 years of age .
METHODS	We performed a randomized , international , double-blind , phase 2b-3 study of the 9vHPV vaccine in 14,215 women .
METHODS	Participants received the 9vHPV vaccine or the qHPV vaccine in a series of three intramuscular injections on day 1 and at months 2 and 6 .
METHODS	Serum was collected for analysis of antibody responses .
METHODS	Swabs of labial , vulvar , perineal , perianal , endocervical , and ectocervical tissue were obtained and used for HPV DNA testing , and liquid-based cytologic testing ( Papanicolaou testing ) was performed regularly .
METHODS	Tissue obtained by means of biopsy or as part of definitive therapy ( including a loop electrosurgical excision procedure and conization ) was tested for HPV .
RESULTS	The rate of high-grade cervical , vulvar , or vaginal disease irrespective of HPV type ( i.e. , disease caused by HPV types included in the 9vHPV vaccine and those not included ) in the modified intention-to-treat population ( which included participants with and those without prevalent infection or disease ) was 14.0 per 1000 person-years in both vaccine groups .
RESULTS	The rate of high-grade cervical , vulvar , or vaginal disease related to HPV-31 , 33 , 45 , 52 , and 58 in a prespecified per-protocol efficacy population ( susceptible population ) was 0.1 per 1000 person-years in the 9vHPV group and 1.6 per 1000 person-years in the qHPV group ( efficacy of the 9vHPV vaccine , 96.7 % ; 95 % confidence interval , 80.9 to 99.8 ) .
RESULTS	Antibody responses to HPV-6 , 11 , 16 , and 18 were noninferior to those generated by the qHPV vaccine .
RESULTS	Adverse events related to injection site were more common in the 9vHPV group than in the qHPV group .
CONCLUSIONS	The 9vHPV vaccine prevented infection and disease related to HPV-31 , 33 , 45 , 52 , and 58 in a susceptible population and generated an antibody response to HPV-6 , 11 , 16 , and 18 that was noninferior to that generated by the qHPV vaccine .
CONCLUSIONS	The 9vHPV vaccine did not prevent infection and disease related to HPV types beyond the nine types covered by the vaccine .
CONCLUSIONS	( Funded by Merck ; ClinicalTrials.gov number , NCT00543543 ) .

###25282519
BACKGROUND	Heterozygous familial hypercholesterolaemia is characterised by low cellular uptake of LDL cholesterol , increased plasma LDL cholesterol concentrations , and premature cardiovascular disease .
BACKGROUND	Despite intensive statin therapy , with or without ezetimibe , many patients are unable to achieve recommended target levels of LDL cholesterol .
BACKGROUND	We investigated the effect of PCSK9 inhibition with evolocumab ( AMG 145 ) on LDL cholesterol in patients with this disorder .
METHODS	This multicentre , randomised , double-blind , placebo-controlled trial was undertaken at 39 sites ( most of which were specialised lipid clinics , mainly attached to academic institutions ) in Australia , Asia , Europe , New Zealand , North America , and South Africa between Feb 7 and Dec 19 , 2013.331 eligible patients ( 18-80 years of age ) , who met clinical criteria for heterozygous familial hypercholesterolaemia and were on stable lipid-lowering therapy for at least 4 weeks , with a fasting LDL cholesterol concentration of 26 mmol/L or higher , were randomly allocated in a 2:2:1:1 ratio to receive subcutaneous evolocumab 140 mg every 2 weeks , evolocumab 420 mg monthly , or subcutaneous placebo every 2 weeks or monthly for 12 weeks .
METHODS	Randomisation was computer generated by the study sponsor , implemented by a computerised voice interactive system , and stratified by LDL cholesterol concentration at screening ( higher or lower than 41 mmol/L ) and by baseline ezetimibe use ( yes/no ) .
METHODS	Patients , study personnel , investigators , and Amgen study staff were masked to treatment assignments within dosing frequency groups .
METHODS	The coprimary endpoints were percentage change from baseline in LDL cholesterol at week 12 and at the mean of weeks 10 and 12 , analysed by intention-to-treat .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01763918 .
RESULTS	Of 415 screened patients , 331 were eligible and were randomly assigned to the four treatment groups : evolocumab 140 mg every 2 weeks ( n = 111 ) , evolocumab 420 mg monthly ( n = 110 ) , placebo every 2 weeks ( n = 55 ) , or placebo monthly ( n = 55 ) .
RESULTS	329 patients received at least one dose of study drug .
RESULTS	Compared with placebo , evolocumab at both dosing schedules led to a significant reduction in mean LDL cholesterol at week 12 ( every-2-weeks dose : 592 % reduction [ 95 % CI 534-651 ] , monthly dose : 613 % reduction [ 536-690 ] ; both p < 00001 ) and at the mean of weeks 10 and 12 ( 602 % reduction [ 95 % CI 545-658 ] and 656 % reduction [ 598-713 ] ; both p < 00001 ) .
RESULTS	Evolocumab was well tolerated , with rates of adverse events similar to placebo .
RESULTS	The most common adverse events occurring more frequently in the evolocumab-treated patients than in the placebo groups were nasopharyngitis ( in 19 patients [ 9 % ] vs five [ 5 % ] in the placebo group ) and muscle-related adverse events ( ten patients [ 5 % ] vs 1 [ 1 % ] ) .
CONCLUSIONS	In patients with heterozygous familial hypercholesterolaemia , evolocumab administered either 140 mg every 2 weeks or 420 mg monthly was well tolerated and yielded similar and rapid 60 % reductions in LDL cholesterol compared with placebo .
BACKGROUND	Amgen Inc. .

###25199046
BACKGROUND	There are high attrition rates observed in efficacy studies for social anxiety disorder , and research has not identified consistent nor theoretically meaningful predictors of dropout .
BACKGROUND	Pre-treatment symptom severity and demographic factors , such as age and gender , are sometimes predictive of dropout .
BACKGROUND	The current study examines a theoretically meaningful predictor of attrition based on experiences associated with social group membership rather than differences between social group categories -- fear of confirming stereotypes .
METHODS	This is a secondary data analysis of a randomized controlled trial comparing two cognitive behavioral treatments for social anxiety disorder : virtual reality exposure therapy and exposure group therapy .
METHODS	Participants ( N = 74 ) with a primary diagnosis of social anxiety disorder who were eligible to participate in the parent study and who self-identified as either `` African American '' ( n = 31 ) or `` Caucasian '' ( n = 43 ) completed standardized self-report measures of stereotype confirmation concerns ( SCC ) and social anxiety symptoms as part of a pre-treatment assessment battery .
RESULTS	Hierarchical logistic regression showed that greater stereotype confirmation concerns were associated with higher dropout from therapy -- race , age , gender , and pre-treatment symptom severity were not .
RESULTS	Group treatment also was associated with higher dropout .
CONCLUSIONS	These findings urge further research on theoretically meaningful predictors of attrition and highlight the importance of addressing cultural variables , such as the experience of stereotype confirmation concerns , during treatment of social anxiety to minimize dropout from therapy .

###24768678
OBJECTIVE	We evaluated the efficacy and safety of high-dose swallowed fluticasone propionate ( FP ) and dose reduction in patients with eosinophilic esophagitis ( EoE ) and analyzed esophageal transcriptomes to identify mechanisms .
METHODS	We conducted a randomized , multisite , double-blind , placebo-controlled trial of daily 1760 mcg FP in participants age 3-30 years with active EoE .
METHODS	Twenty-eight participants received FP , and 14 participants received placebo .
METHODS	After 3 months , participants given FP who were in complete remission ( CR ) received 880 mcg FP daily , and participants in the FP or placebo groups who were not in CR continued or started , respectively , 1760 mcg FP daily for 3 additional months .
METHODS	The primary end point was histologic evidence for CR .
METHODS	Secondary end points were partial remission ( PR ) , symptoms , compliance , esophageal gene expression , esophageal eosinophil count , and the relationship between clinical features and FP responsiveness .
RESULTS	After 3 months , 65 % of subjects given FP and no subjects given placebo were in CR ( P = .0001 ) ; 12 % of those given FP and 8 % of those given placebo were in PR .
RESULTS	In the FP group , 73 % of subjects remained in CR , and 20 % were in PR after the daily dose was reduced by 50 % .
RESULTS	Extending FP therapy in FP-resistant participants did not induce remission .
RESULTS	FP decreased heartburn severity ( P = .041 ) .
RESULTS	Compliance , age , sex , atopic status , or anthropomorphic features were not associated with response to FP .
RESULTS	Gene expression patterns in esophageal tissues of FP responders were similar to those of patients without EoE ; there was evidence for heterogeneous steroid signaling in subjects who did not respond to FP and preliminary evidence for transcripts predictive of FP responsiveness .
CONCLUSIONS	Daily administration of a high dose of FP induces histologic remission in 65 % -77 % of patients with EoE after 3 months .
CONCLUSIONS	A 50 % dose reduction remained effective in 73 % -93 % of patients who initially responded to FP .
CONCLUSIONS	Nonresponders had evidence of steroid resistance ; histologic and molecular markers may predict resistance .
CONCLUSIONS	Clinicaltrials.gov number : NCT00426283 .

###25518875
BACKGROUND	Falls and fall-related injuries are a serious cause of morbidity and cost to society .
BACKGROUND	Foot problems and inappropriate footwear may increase the risk of falls ; therefore podiatric interventions may play a role in reducing falls .
BACKGROUND	Two Cochrane systematic reviews identified only one study of a podiatry intervention aimed to reduce falls , which was undertaken in Australia .
BACKGROUND	The REFORM trial aims to evaluate the clinical and cost-effectiveness of a multifaceted podiatry intervention in reducing falls in people aged 65 years and over in a UK and Irish setting .
METHODS	This multicentre , cohort randomised controlled trial will recruit 2600 participants from routine podiatry clinics in the UK and Ireland to the REFORM cohort .
METHODS	In order to detect a 10 % point reduction in falls from 50 % to 40 % , with 80 % power 890 participants will be randomised to receive routine podiatry care and a falls prevention leaflet or routine podiatry care , a falls prevention leaflet and a multifaceted podiatry intervention .
METHODS	The primary outcome is rate of falls ( falls/person/time ) over 12 months assessed by patient self-report falls diary .
METHODS	Secondary self-report outcome measures include : the proportion of single and multiple fallers and time to first fall over a 12-month period ; Short Falls Efficacy Scale-International ; fear of falling in the past 4 weeks ; Frenchay Activities Index ; fracture rate ; Geriatric Depression Scale ; EuroQoL-five dimensional scale 3-L ; health service utilisation at 6 and 12 months .
METHODS	A qualitative study will examine the acceptability of the package of care to participants and podiatrists .
BACKGROUND	The trial has received a favourable opinion from the East of England-Cambridge East Research Ethics Committee and Galway Research Ethics Committee .
BACKGROUND	The trial results will be published in peer-reviewed journals and at conference presentations .
BACKGROUND	Current Controlled Trials ISRCTN68240461 assigned 01/07/2011 .

###24660224
BACKGROUND	For many patients with generalized anxiety disorder ( GAD ) , first-line treatment does not lead to remission .
BACKGROUND	This study investigated the efficacy and tolerability of adjunctive extended-release quetiapine fumarate ( quetiapine XR ) in patients with GAD and an inadequate response to selective serotonin reuptake inhibitors ( SSRIs ) and serotonin-norepinephrine reuptake inhibitors ( SNRIs ) .
METHODS	Patients were randomized to quetiapine XR or placebo adjunctive to SSRI/SNRIs in an 11-week study .
METHODS	The primary endpoint was change from randomization to week 8 in Hamilton Anxiety Rating Scale ( HAM-A ) total score .
METHODS	Secondary variables were HAM-A psychic/somatic clusters , response , and remission , and Clinical Global ImpressionSeverity of Illness ( CGI-S ) score .
RESULTS	A total of 409 patients received quetiapine XR ( n = 209 ) or placebo ( n = 200 ) .
RESULTS	The week 8 mean change in HAM-A total score was not statistically significant for quetiapine XR ( 10.74 ; P = .079 ) vs placebo ( 9.61 ) .
RESULTS	Secondary variables were generally consistent with the primary analysis , except for a significant reduction in HAM-A total score ( week 1 ) and significant improvements in HAM-A psychic cluster and CGI-S total scores ( week 8 ) .
RESULTS	Adverse events included dry mouth , somnolence , sedation , headache , and dizziness .
CONCLUSIONS	In patients with GAD and an inadequate response to SSRI/SNRIs , adjunctive quetiapine XR did not show a statistically significant effect for the primary endpoint at week 8 , although some secondary endpoints were statistically significant vs placebo .
CONCLUSIONS	Quetiapine XR was generally well tolerated .

###25687147
OBJECTIVE	Increasing data suggest that neonatal pain has long-term consequences .
OBJECTIVE	Nonpharmacologic techniques ( sucrose taste , pacifier suckling , breastfeeding ) are effective and now widely used to combat minor neonatal pain .
OBJECTIVE	This study examined the analgesic effect of sucrose combined with radiant warmth compared with the taste of sucrose alone during a painful procedure in healthy full-term newborns .
METHODS	A randomized , controlled trial included 29 healthy , full-term newborns born at the University of Chicago Hospital .
METHODS	Both groups of infants were given 1.0 mL of 25 % sucrose solution 2 minutes before the vaccination , and 1 group additionally was given radiant warmth from an infant warmer before the vaccination .
METHODS	We assessed pain by comparing differences in cry , grimace , heart rate variability ( ie , respiratory sinus arrhythmia ) , and heart rate between the groups .
RESULTS	The sucrose plus warmer group cried and grimaced for 50 % less time after the vaccination than the sucrose alone group ( P < .05 , respectively ) .
RESULTS	The sucrose plus warmer group had lower heart rate and heart rate variability ( ie , respiratory sinus arrhythmia ) responses compared with the sucrose alone group ( P < .01 ) , reflecting a greater ability to physiologically regulate in response to the painful vaccination .
CONCLUSIONS	The combination of sucrose and radiant warmth is an effective analgesic in newborns and reduces pain better than sucrose alone .
CONCLUSIONS	The ready availability of this practical nonpharmacologic technique has the potential to reduce the burden of newborn pain .

###24467807
BACKGROUND	Major Depressive Disorder is one of the most challenging mental health problems of our time .
BACKGROUND	Although effective psychotherapeutic treatments are available , many patients fail to demonstrate clinically significant improvements .
BACKGROUND	Difficulties in emotion regulation have been identified as putative risk and maintaining factors for Major Depressive Disorder .
BACKGROUND	Systematically enhancing adaptive emotion regulation skills should thus help reduce depressive symptom severity .
BACKGROUND	However , at this point , no study has systematically evaluated effects of increasing adaptive emotion regulation skills application on symptoms of Major Depressive Disorder .
BACKGROUND	In the intended study , we aim to evaluate stand-alone effects of a group-based training explicitly and exclusively targeting general emotion regulation skills on depressive symptom severity and assess whether this training augments the outcome of subsequent individual cognitive behavioral therapy for depression .
METHODS	In the evaluation of the Affect Regulation Training , we will conduct a prospective randomized-controlled trial .
METHODS	Effects of the Affect Regulation Training on depressive symptom severity and outcomes of subsequent individual therapy for depression will be compared with an active , common factor based treatment and a waitlist control condition .
METHODS	The study sample will include 120 outpatients meeting criteria for Major Depressive Disorder .
METHODS	Depressive symptom severity as assessed by the Hamilton Rating Scale will serve as our primary study outcome .
METHODS	Secondary outcomes will include further indicators of mental health and changes in adaptive emotion regulation skills application .
METHODS	All outcomes will be assessed at intake and at 10 points in time over the course of the 15-month study period .
METHODS	Measures will include self-reports , observer ratings , momentary ecological assessments , and will be complemented in subsamples by experimental investigations and the analysis of hair steroids .
CONCLUSIONS	If findings should support the hypothesis that enhancing regulation skills reduces symptom severity in Major Depressive Disorder , systematic emotion regulation skills training can enhance the efficacy and efficiency of current treatments for this severe and highly prevalent disorder .
BACKGROUND	This study is registered with ClinicalTrials.gov , number NCT01330485 .

###24300949
OBJECTIVE	This study aims to determine the long-term effects of a new Memory Self-efficacy ( MSE ) training program for stroke patients on MSE , depression , and quality of life .
METHODS	In a randomized controlled trial , patients were allocated to a MSE training or a peer support group .
METHODS	Outcome measures were MSE , depression , and quality of life , measured with the Metamemory-In-Adulthood questionnaire , Center for Epidemiological Studies-Depression Scale ( CES-D ) , and the Who-Qol Bref questionnaire , respectively .
METHODS	We used linear mixed models to compare the outcomes of both groups immediately after training , after 6 months , and after 12 months , adjusted for baseline .
RESULTS	In total , 153 former inpatients from 2 rehabilitation centers were randomized-77 to the experimental and 76 to the control group .
RESULTS	MSE increased significantly more in the experimental group and remained significantly higher than in the control group after 6 and 12 months ( B = 0.42 ; P = .010 ) .
RESULTS	Psychological quality of life also increased more in the experimental group but not significantly ( B = 0.09 ; P = .077 ) .
RESULTS	However , in the younger subgroup of patients ( < 65 years old ) , psychological quality of life significantly improved in the experimental group compared to the control group and remained significantly higher over time ( B = 0.14 ; P = .030 ) .
RESULTS	Other outcome measures were not significantly different between both groups .
CONCLUSIONS	An MSE training program improved MSE and psychological quality of life in stroke patients aged < 65 years .
CONCLUSIONS	These effects persisted during 12 months of follow-up .

###24638046
BACKGROUND	Non-adherence to antidepressant treatment is not routinely measured in practical clinical trials .
BACKGROUND	It has not been related to outcomes in a large sample of adults with chronic and/or recurrent major depressive disorder ( MDD ) or any sample treated with antidepressant combinations .
METHODS	Adult outpatients with chronic and/or recurrent MDD were randomized to 12 weeks of treatment with bupropion-SR plus escitalopram , venlafaxine-XR plus mirtazapine , or escitalopram plus placebo .
METHODS	We compared non-adherence ( the frequency with which daily medications were not taken ) and specifically the frequency of temporarily stopping and/or skipping medication , or reducing or increasing the dose across treatments in 567 participants using a self-report questionnaire collected at each visit .
METHODS	We tested the association between non-adherence , and both treatment type and outcomes .
RESULTS	A non-adherence rate under 10 % was reported by 77.9 % , 70.9 % , and 71.6 % of participants during weeks 1-4 , 5-12 , and 1-12 , respectively .
RESULTS	Antidepressant combinations were associated with a higher non-adherence rate than monotherapy during weeks 1-4 and 1-12 .
RESULTS	During weeks 1-4 , 24.1 % stopped/skipped doses and 6.1 % reduced the dose .
RESULTS	During weeks 5-12 , 34.7 % stopped/skipped doses and 9.4 % reduced the dose .
RESULTS	Across 12 weeks , 43.2 % stopped/skipped doses , and 12.9 % reduced the dose .
RESULTS	Stopping/skipping doses during all time frames and dose decreases during weeks 1-12 occurred most frequently with combination treatments .
RESULTS	Non-adherence was unrelated to symptom remission , response , or symptom change .
CONCLUSIONS	With closely monitored treatment , non-adherence is low and unrelated to depressive symptom outcome .
CONCLUSIONS	Nonadherence is highest with antidepressant combinations .
CONCLUSIONS	Specific non-adherent events are most often sporadic .

###25069393
BACKGROUND	Occupational quartz exposure continues to be a serious hazard in the construction industry .
BACKGROUND	Until now , evidence-based interventions aimed at reducing quartz exposure are scarce .
BACKGROUND	The aim of this study was to systematically develop an intervention and to describe the study to evaluate its effectiveness .
METHODS	The intervention was developed according to the principles of the Intervention Mapping protocol , meaning that evidence from the literature was combined with information collected from stakeholders ( e.g. , construction workers , managers and researchers ) .
METHODS	The intervention aimed to integrate technical , behavioural and organizational factors .
METHODS	The intervention consists of two plenary meetings for all employers within the company , and individual visits at construction worksites , including specific intervention materials .
METHODS	Additionally , a demonstration session regarding control measures was organized for all managers .
METHODS	The effectiveness of the intervention will be evaluated in a cluster randomized controlled trial among eight construction companies , with measurements at baseline and follow-up .
METHODS	Outcome measures are personal respirable dust and quartz exposure by means of exposure assessment , and behavioural and organizational determinants which will be assessed by means of questionnaires .
METHODS	Additionally , a process evaluation will shed light on whether the intervention ( does not ) works , and , if so , the reasons for this .
CONCLUSIONS	Applying Intervention Mapping in the development of an intervention to reduce occupational quartz exposure was useful , as different stakeholders provided input for the intervention as well as the implementation strategy .
CONCLUSIONS	Therefore , the feasibility of the intervention has been enhanced , as it appeals to construction workers and managers and will not unduly interfere with the ongoing construction work .
BACKGROUND	NTR4586 ( May 7th 2014 ) .

###26166166
OBJECTIVE	To observe the effect on total liver volume ( TLV ) on and off therapy in selected symptomatic patients with autosomal dominant polycystic kidney disease ( ADPKD ) or autosomal dominant polycystic liver disease ( PLD ) who received octreotide long-acting release ( OctLAR ) for up to 4 years .
METHODS	Twenty-eight of 42 participants in a prospective 2-year clinical trial of OctLAR ( 40 mg monthly ) consisting of double-blind , randomized ( year 1 ) and open-label treatment ( year 2 ) phases reenrolled in a 2-year open-label extension ( OLE ) study after being off OctLAR a mean of 8.3 months ( original study : July 1 , 2007 , through June 30 , 2013 ) .
METHODS	Participants underwent magnetic resonance imaging at baseline , years 1 and 2 , reenrollment , and study completion .
METHODS	Primary end point : change in TLV ; secondary end points : changes in total kidney volume , glomerular filtration rate , quality of life ( QoL ) , safety , vital signs , and laboratory parameters .
RESULTS	Twenty-five participants ( 59.5 % ) completed the OLE .
RESULTS	Off therapy , TLVs increased a mean SD of 3.4 % 8.2 % per year ; after resuming therapy , TLVs decreased a mean SD of -4.7 % 6.1 % per year .
RESULTS	Despite regrowth off treatment , overall reductions were observed , with a median ( interquartile range ) TLV of 4047 mL ( 3107-7402 mL ) at baseline and 3477 ( 2653-7131 mL ) at study completion ( -13.2 % ; P < .001 ) and with improved health-related QoL .
RESULTS	Total kidney volumes increased , and glomerular filtration rates declined from 58.2 mL/min to 54.5 mL/min ( n = 16 ) in patients with ADPKD on therapy from baseline to study completion .
CONCLUSIONS	Therapy with OctLAR over 4 years in selected patients with symptomatic PLD arrested PLD progression , alleviating symptoms and improving health-related QoL .
CONCLUSIONS	Discontinuation led to organ regrowth .
BACKGROUND	clinicaltrials.gov Identifier : NCT00426153 .

###25727933
BACKGROUND	The best suture method to prevent incisional surgical-site infection ( SSI ) after clean-contaminated surgery has not been clarified .
METHODS	Patients undergoing elective colorectal cancer surgery at one of 16 centres were randomized to receive either subcuticular sutures or skin stapling for skin closure .
METHODS	The primary endpoint was the rate of incisional SSI .
METHODS	Secondary endpoints of interest included time required for wound closure , incidence of wound problems , postoperative length of stay , wound aesthetics and patient satisfaction .
RESULTS	A total of 1264 patients were enrolled .
RESULTS	The cumulative incidence of incisional SSI by day 30 after surgery was similar after subcuticular sutures and stapled closure ( 87 versus 98 per cent respectively ; P = 0576 ) .
RESULTS	Comparison of cumulative incidence curves revealed that SSI occurred later in the subcuticular suture group ( P = 0019 ) ( hazard ratio 066 , 95 per cent c.i. 045 to 097 ) .
RESULTS	Wound problems ( P = 0484 ) , wound aesthetics ( P = 0182 ) and postoperative duration of hospital stay ( P = 0510 ) did not differ between the groups ; subcuticular sutures took 5min longer than staples ( P < 0001 ) .
RESULTS	Patients in the subcuticular suture group were significantly more satisfied with their wound ( 524 per cent versus 427 per cent in the staple group ; P = 0002 ) .
CONCLUSIONS	Compared with skin stapling , subcuticular sutures did not reduce the risk of incisional SSI after colorectal surgery .
BACKGROUND	UMIN000004001 ( http://www.umin.ac.jp/ctr ) .

###24399120
BACKGROUND	Chronic prostatitis displays a variety of symptoms ( mainly local pain exhibiting variability in origin and intensity ) .
BACKGROUND	The purpose of this article is to briefly present the preliminary results of our study examining the role of phytotherapeutic agents in the treatment of chronic prostatitis patients .
METHODS	The study included in total fifty-six consecutive patients who visited the outpatient department .
METHODS	Subjects were randomized into two groups .
METHODS	Subjects in the first group ( 28 patients ) received prulifloxacin 600 mg for 15 days , while subjects in the second group ( 28 patients ) received prulifloxacin 600 mg for 15 days and Serenoa repens extract for 8 weeks .
METHODS	The response was tested using laboratory and clinical criteria .
RESULTS	We found statistically significant differences between the two groups regarding pain regression and no statistically significant regarding bacterial eradication .
RESULTS	Moreover however while sexual dysfunction improvement was equally achieved in both groups , improvement of urinary symptoms was more evident in the 2nd group especially after the completion of the antibiotic treatment .
CONCLUSIONS	Serenoa repens extract for 8 weeks seems to improve prostatitis related pain .
CONCLUSIONS	Further randomized , placebo-controlled studies are needed to substantiate safer conclusions .

###24901128
OBJECTIVE	This study aims to identify the optimal mini-invasive treatment for extrahepatic bile duct stones .
METHODS	One hundred and seventy eight patients with EHBD stones were randomized into 4 groups : laparoscopic cholecystectomy ( LC ) and laparoscopic common bile duct exploration ( LCBDE ) plus T-tube drainage ( group LT ) , LC and LCBDE with endonasobiliary drainage ( ENBD ) tube ( group LE ) , and endoscopic sphincterotomy with ENBD followed by LC ( group EE ) and T-tube drainage of open CBDE ( group OT ) .
METHODS	Demographic data , perioperative findings , postoperative outcomes , hospital expense , gastrointestinal quality of life index ( GIQLI ) scores and cost per quality-adjusted life year ( QALY ) were analyzed .
RESULTS	The operating time was longest in group EE .
RESULTS	There was less bleeding in group OT and EE .
RESULTS	Group LE and EE had shorter hospital stay and recovery time of intestinal motility .
RESULTS	The postoperative white blood cell count and serum C-reaction protein level were higher in group LT and OT .
RESULTS	Postoperatively , the mean GIQLI scores in group LE and EE were higher .
RESULTS	Mean cost were highest in group EE .
RESULTS	Patients in group LE had lowest cost per QALY .
CONCLUSIONS	The modified laparoscopic procedure , LC combined with LCBDE followed by a primary closure over the ENBD tubes , appears to be the best option for patients with EHBD stones .

###25337871
OBJECTIVE	Because of the restrictions applied to the conduct of randomized clinical trials , the risks reported in their comparison of open and endovascular aneurysm repair ( EVAR ) of abdominal aortic aneurysms ( AAA ) may not be applicable to real-world vascular surgical practice .
OBJECTIVE	The magnitude of this deviation is indeterminate .
OBJECTIVE	To compare 30-day mortality from the recent Open Vs Endovascular Repair ( OVER ) Veterans Affairs Cooperative trial with results obtained from the American College of Surgeons National Surgical Quality Improvement Program ( NSQIP ) and to assess temporal trends in perioperative mortality .
METHODS	We analyzed data from 21,115 patients who received elective EVAR or open repair for asymptomatic infrarenal AAA between January 1 , 2005 , and December 31 , 2011 , in the NSQIP database .
METHODS	We used 2 and t tests to compare perioperative mortality between groups .
METHODS	Logistic regression was used to analyze perioperative mortality , adjusting for age , sex , race , and comorbidities .
METHODS	The outcomes of the OVER trial were then compared with the national estimates obtained from the NSQIP .
METHODS	Death within 30 days of surgery .
RESULTS	Perioperative mortality was 3.7 % ( 95 % CI , 3.2 % -4.3 % ) after open repair and 1.3 % ( 95 % CI , 1.2 % -1.5 % ) after EVAR .
RESULTS	There was a 70 % reduction in operative mortality after EVAR compared with open repair ( adjusted odds ratio [ aOR ] , 0.30 ; 95 % CI , 0.25-0 .38 ; P < .001 ) .
RESULTS	Mortality was significantly lower in men compared with women ( aOR , 0.73 ; 95 % CI , 0.57-0 .92 ; P = .009 ) .
RESULTS	Thirty-day mortality in the NSQIP cohort was higher than that reported in the OVER trial for both EVAR and open repair ( EVAR , 1.3 % vs 0.2 % ; open , 3.7 % vs 2.3 % ) .
RESULTS	There was an increase in the proportion of patients who received EVAR during the 7 years studied ( 65 % in 2005 and 80 % in 2011 ) .
RESULTS	There has been no significant decrease in perioperative mortality during these years ( P > .05 ) .
CONCLUSIONS	Perioperative mortality reported by the OVER trial is significantly lower than outcomes from practices outside the restriction of randomized clinical trials .
CONCLUSIONS	We attribute this difference to the fact that the OVER trial excluded high-risk patients deemed unfit for open repair .
CONCLUSIONS	This finding supports the need for individualized assessment of risk and treatment selection for patients with infrarenal AAA .
CONCLUSIONS	There has been no change in perioperative mortality after EVAR in recent years despite improvements in techniques , devices , and proficiency .

###25775072
OBJECTIVE	We hypothesized that immediate laparoscopic surgery for appendiceal abscess would result in faster recovery than conservative treatment .
BACKGROUND	On the basis of the retrospective studies , conservative management of appendiceal abscess is recommended as a first line treatment , but some controversy exists .
METHODS	Sixty adult patients diagnosed with appendiceal abscess were randomly assigned to either laparoscopic surgery ( n = 30 ) or conservative treatment ( n = 30 ) .
METHODS	Hospital stay , recurrences , additional interventions , and complications within 60 days from randomization were recorded .
RESULTS	There was no difference in hospital stay : 4 days ( interquartile range : 3-5 days ) in the laparoscopy group versus 5 days ( 3-8 ) in the conservative group , P = 0.105 .
RESULTS	Patients in the laparoscopy group had 10 % risk for bowel resection and 13 % risk for incomplete appendectomy .
RESULTS	There were significantly fewer patients with unplanned readmissions in the laparoscopy group : 1 ( 3 % ) versus 8 ( 27 % ) , P = 0.026 .
RESULTS	Additional interventions were required in 2 ( 7 % ) patients in the laparoscopy group ( percutaneous drainage ) and in 9 ( 30 % ) patients in the conservative group ( surgery ) , P = 0.042 .
RESULTS	Recurrent abscesses and failure to respond to conservative treatment were the main reasons for additional interventions .
RESULTS	Open surgery was required in 3 ( 10 % ) patients in the laparoscopy group and in 4 ( 13 % ) patients in the conservative group .
RESULTS	Postoperative complications occurred in 3 patients in laparoscopic group versus 2 patients in the conservative group .
RESULTS	The rate of uneventful recovery was 90 % in the laparoscopy group versus 50 % in the conservative group , P = 0.002 .
CONCLUSIONS	Laparoscopic surgery in experienced hands is safe and feasible first-line treatment for appendiceal abscess .
CONCLUSIONS	It is associated with fewer readmissions and fewer additional interventions than conservative treatment with comparable hospital stay .

###24902959
BACKGROUND	Home and community-based combined treatment of malaria and pneumonia has been promoted in Uganda since mid 2011 .
BACKGROUND	The combined treatment is justified given the considerable overlap between the symptoms of malaria and pneumonia among infants .
BACKGROUND	There is limited evidence about the extent to which community-based care reduces healthcare-seeking costs at the household level in rural and urban settings .
BACKGROUND	This paper assesses the rural-urban differences in direct and indirect costs of seeking care from formal health facilities compared to community medicine distributors ( CMDs ) .
METHODS	Exit interviews were conducted for 282 ( 159 rural and 123 urban ) caregivers of children below five years who had received treatment for fever-related illnesses at selected health centres in Iganga and Mayuge districts .
METHODS	Data on the direct and indirect costs incurred while seeking care at the health centre visited were obtained .
METHODS	Using another tool , household level direct and indirect costs of seeking care from CMDs were collected from a total of 470 caregivers ( 304 rural and 166 urban ) .
METHODS	Costs incurred at health facilities were then compared with costs of seeking care from CMDs .
RESULTS	Household direct costs of seeking care from health facilities were significantly higher for urban-based caregivers than the rural ( median cost = US$ 0.42 for urban and zero for rural ; p < 0.0001 ) .
RESULTS	The same is true for seeking care from CMDs ( p = 0.0038 ) .
RESULTS	Overall , caregivers travelled for an average of 75min to reach health centres and spent an average of 80min at the health centre while receiving treatment .
RESULTS	However , households in rural areas travelled for a significantly longer time ( p < 0.001 to reach health care facilities than the urban-based caregivers .
RESULTS	Besides travelling longer distances , rural caregivers spent 150min seeking care from health facilities compared to 30min from CMDs .
CONCLUSIONS	Time and monetary savings for seeking care from CMDs are significantly larger for rural than urban households .
CONCLUSIONS	Thus , home and community-based treatment of child febrile illnesses is much more cost-saving for rural poor communities , who would spend more time travelling to health facilities - which time could be re-directed to productive and income-generating activities .

###24275953
BACKGROUND	Use of pretest probability can reduce unnecessary testing .
BACKGROUND	We hypothesize that quantitative pretest probability , linked to evidence-based management strategies , can reduce unnecessary radiation exposure and cost in low-risk patients with symptoms suggestive of acute coronary syndrome and pulmonary embolism .
RESULTS	This was a prospective , 4-center , randomized controlled trial of decision support effectiveness .
RESULTS	Subjects were adults with chest pain and dyspnea , nondiagnostic ECGs , and no obvious diagnosis .
RESULTS	The clinician provided data needed to compute pretest probabilities from a Web-based system .
RESULTS	Clinicians randomized to the intervention group received the pretest probability estimates for both acute coronary syndrome and pulmonary embolism and suggested clinical actions designed to lower radiation exposure and cost .
RESULTS	The control group received nothing .
RESULTS	Patients were followed for 90 days .
RESULTS	The primary outcome and sample size of 550 was predicated on a significant reduction in the proportion of healthy patients exposed to > 5 mSv chest radiation .
RESULTS	A total of 550 patients were randomized , and 541 had complete data .
RESULTS	The proportion with > 5 mSv to the chest and no significant cardiopulmonary diagnosis within 90 days was reduced from 33 % to 25 % ( P = 0.038 ) .
RESULTS	The intervention group had significantly lower median chest radiation exposure ( 0.06 versus 0.34 mSv ; P = 0.037 , Mann-Whitney U test ) and lower median costs ( $ 934 versus $ 1275 ; P = 0.018 ) for medical care .
RESULTS	Adverse events occurred in 16 % of controls and 11 % in the intervention group ( P = 0.06 ) .
CONCLUSIONS	Provision of pretest probability and prescriptive advice reduced radiation exposure and cost of care in low-risk ambulatory patients with symptoms of acute coronary syndrome and pulmonary embolism .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01059500 .

###25641242
OBJECTIVE	To evaluate vasopressin vs dopamine as initial therapy in extremely low birth weight ( ELBW ) infants with hypotension during the first 24 hours of life .
METHODS	ELBW infants with hypertension 30 weeks ' gestation and 24 hours old randomly received treatment with vasopressin or dopamine in a blinded fashion .
METHODS	Normotensive infants not receiving vasopressor support served as a comparison group .
RESULTS	Twenty ELBW infants with hypertension received vasopressin ( n = 10 ) or dopamine ( n = 10 ) , and 50 were enrolled for comparison .
RESULTS	Mean gestational age was 25.6 1.4 weeks and birth weight 705 154 g. Response to vasopressin paralleled that of dopamine in time to adequate mean blood pressure ( Kaplan-Meier curve , P = .986 ) ; 90 % of infants in each treatment group responded with adequate blood pressure .
RESULTS	The vasopressin group received fewer doses of surfactant ( P < .05 ) , had lower PaCO2 values ( P < .05 ) , and were not tachycardic ( P < .001 ) during vasopressin administration , compared with the dopamine group .
CONCLUSIONS	Vasopressin in ELBW infants as the initial agent for early hypotension appeared safe .
CONCLUSIONS	This pilot study supports a larger randomized controlled trial of vasopressin vs dopamine therapy in ELBW infants with hypotension .

###24582316
BACKGROUND	Approximately 5 % to 10 % of asthmatic patients achieve incomplete symptom control on current therapies .
BACKGROUND	The association of IL-13 with asthma pathology and reduced corticosteroid sensitivity suggests a potential benefit of anti-IL-13 therapy in refractory asthma .
BACKGROUND	GSK679586 , a humanized mAb , inhibits IL-13 binding to both IL-13 receptor 1 and 2 .
OBJECTIVE	We sought to evaluate the efficacy and safety of GSK679586 in patients with severe asthma refractory to maximally indicated doses of inhaled corticosteroids .
METHODS	Patients who remained symptomatic ( Asthma Control Questionnaire score 1.5 ) after uptitration to 1000 g/d fluticasone propionate or greater were randomized to 3 once-monthly intravenous infusions of 10 mg/kg GSK679586 ( n = 99 ) or placebo ( n = 99 ) .
RESULTS	Treatment differences in adjusted mean change from baseline over 12 weeks were nonsignificant for Asthma Control Questionnaire symptom scores ( the primary end point ; GSK679586 = -0.31 , placebo = -0.17 , P = .058 ) and FEV ( GSK679586 = -0.01 , placebo = 0.03 , P = .276 ) .
RESULTS	Similar analyses in patients with increased serum IgE levels , blood eosinophil counts , or both were also negative .
RESULTS	Incidence of asthma exacerbations was similar between treatments .
RESULTS	Most adverse events were nonserious and unrelated to treatment .
RESULTS	Two GSK679586-treated patients had treatment-related serious adverse events ( lethargy and supraventricular extrasystoles ) .
CONCLUSIONS	Although well tolerated , GSK679586 did not demonstrate clinically meaningful improvements in asthma control , pulmonary function , or exacerbations in patients with severe asthma .
CONCLUSIONS	Further studies are needed to determine whether therapies targeting IL-13 , the functionally related IL-4 cytokine , or both can provide clinical benefit in patients with severe refractory asthma or a subpopulation of these patients beyond that achievable with high-dose corticosteroids .

###25226730
BACKGROUND	Gold standard treatment for symptomatic gall stones is laparoscopic cholecystectomy ( LC ) .
BACKGROUND	Ultrasonically activated devices have been used for gall bladder dissection in LC .
BACKGROUND	Harmonic scalpel ( HS ) is the leading ultrasonically cutting coagulation device offering surgeons important benefits .
BACKGROUND	The main aim of our study was to compare the surgical outcomes of LC performed by HS to that performed by conventional mono-polar diathermy ( electro-cautery ) .
METHODS	This prospective randomized study was conducted in surgical department of Jinnah Postgraduate Medical Centre , Karachi , during May-October 2013 .
METHODS	During this period we selected 92 patients with symptomatic gallstones who underwent LC ; these patients were randomly recruited into two groups using sealed opaque envelopes .
METHODS	Group A underwent gallbladder dissection from its bed using mono-polar diathermy , while on the other hand in Group B the dissection was carried out using harmonic scalpel .
METHODS	The outcomes like gallbladder perforation with bile spillage , intra-operative bleeding and operative time were assessed .
RESULTS	The harmonic scalpel ( HS ) usage in surgery results in shorter operative time , it also leads to less gallbladder injury , bile leakage and stone spillage ( due to minimal lateralization of heat energy ) not only this it also leads to less intra-operative blood loss .
CONCLUSIONS	Harmonic scalpel is a new innovation in gallbladder surgery it has multiple functions like cutting , coagulation , coaptaion and cavitation which have made it safe , handy , effective and reliable instrument .

###24916911
OBJECTIVE	The main objective of the present analysis was to assess the effect of treatment with aspirin compared with apixaban on ischemic stroke and major bleeding in women compared with men .
OBJECTIVE	Female patients with atrial fibrillation are at increased stroke risk compared with male patients , and the underlying reasons for higher risk are uncertain .
METHODS	Ancillary analysis of the Apixaban Versus Acetylsalicylic Acid [ ASA ] to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or Are Unsuitable for Vitamin K Antagonist Treatment ( AVERROES ) trial , comparing aspirin and apixaban , focused on sex differences .
METHODS	Mean follow-up was 1.1 years .
RESULTS	Women compared with men tended to be older ( aspirin , 71.8 versus 68.8 years ; apixaban , 71.4 versus 68.6 years ) , with a higher proportion of those aged75 years .
RESULTS	Also , women had less peripheral artery disease ( aspirin , 2.4 % versus 3.7 % ; apixaban , 1.4 % versus 3.0 % ) , more heart failure , and higher mean CHADS2 ( congestive heart failure , hypertension , age of 75 years or older , diabetes [ 1 point each ] , stroke or transient ischemic attack [ 2 points ] ) scores ( aspirin , 2.2 versus 2.0 ; apixaban , 2.1 versus 2.0 ) .
RESULTS	Women compared with men had higher ischemic stroke rates ( aspirin , 3.99 % versus 2.28 % ; apixaban , 1.55 % versus 0.82 % ) but similar bleeding rates ( aspirin , 1.29 % versus 1.22 % ; apixaban , 1.15 % versus 1.36 % ) .
RESULTS	The relative effect of apixaban compared with aspirin was similar in men and women for both ischemic stroke ( women , 3.99 % versus 1.55 % ; hazard ratio , 0.39 ; 95 % confidence interval , 0.23-0 .64 ; men , 2.28 % versus 0.82 % ; hazard ratio , 0.36 ; 95 % confidence interval , 0.19-0 .63 ; Pint = 0.84 ) and major bleeding ( women , 1.29 % versus 1.15 % ; hazard ratio , 1.15 ; 95 % confidence interval , 0.59-2 .23 ; men , 1.36 % versus 1.22 % ; hazard ratio , 1.13 ; 95 % confidence interval , 0.64-2 .02 ; Pint = 0.96 ) .
CONCLUSIONS	Female patients with atrial fibrillation had higher ischemic stroke rates compared with male patients , but the relative effects of apixaban compared with aspirin on both ischemic stroke and bleeding were similar in men and women .

###25982014
BACKGROUND	Magnetic resonance imaging ( MRI ) of patients with conventional implantable cardioverter-defibrillators ( ICD ) is contraindicated .
OBJECTIVE	This multicenter , randomized trial evaluated safety and efficacy of a novel ICD system specially designed for full-body MRI without restrictions on heart rate or pacing dependency .
OBJECTIVE	The primary safety objective was > 90 % freedom from MRI-related events composite endpoint within 30 days post-MRI .
OBJECTIVE	The primary efficacy endpoints were ventricular pacing capture threshold and ventricular sensing amplitude .
METHODS	Subjects received either a single - or dual-chamber ICD .
METHODS	In a 2:1 randomization , subjects either underwent MRIat 1.5-T of the chest , cervical , and head regions to maximize radiofrequency exposure up to 2 W/kg specific absorption rate and gradient field exposure to 200 T/m/s per axis ( MRI group , n = 175 ) , or they underwent a 1-h waiting period without MRI ( control group , n = 88 ) .
METHODS	A subset of MRI patients underwent ventricular fibrillation induction testing post-MRI to characterize defibrillation function .
RESULTS	In 42 centers , 275 patients were enrolled ( 76 % male , age 60.4 13.8 years ) .
RESULTS	The safety endpoint was met with 100 % freedom from the composite endpoint ( p < 0.0001 ) .
RESULTS	Both efficacy endpoints were met with minimal differences in the proportion of MRI and control patients who demonstrated a0 .5 V increase in ventricular pacing capture threshold ( 100 % MRI vs. 98.8 % control , noninferiority p < 0.0001 ) or a50 % decrease in R-wave amplitude ( 99.3 % MRI vs. 98.8 % control , noninferiority p = 0.0001 ) .
RESULTS	A total of 34 ventricular tachyarrhythmia/ventricular fibrillation episodes ( 20 induced ; 14 spontaneous ) occurred in 24 subjects post-MRI , with no observed effect on sensing , detection , or treatment .
CONCLUSIONS	This is the first randomized clinical study of an ICD system designed for full-body MRI at 1.5-T .
CONCLUSIONS	These data support that the system is safe and the MRI scan does not adversely affect electrical performance or efficacy .
CONCLUSIONS	( Confirmatory Clinical Trial of the Evera MRI System for Conditionally-Safe MRI Access ; NCT02117414 ) .

###25475460
BACKGROUND	A strategy of early transfer for coronary angiography and intervention is superior to a standard approach of delayed coronary angiography after fibrinolysis for ST-elevation myocardial infarction ( STEMI ) .
BACKGROUND	STEMI patients with lesions in noninfarct-related arteries have a worse prognosis compared with patients with single vessel disease .
BACKGROUND	This study aimed to assess whether the benefits of an early invasive strategy differ in patients with single vessel and multivessel disease .
METHODS	The Trial of Routine ANgioplasty and Stenting after Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction ( TRANSFER-AMI ) randomized STEMI patients receiving fibrinolysis to a strategy of early transfer and coronary angiography vs a standard approach .
METHODS	In this post hoc analysis , we stratified 992 patients into 2 groups according to the presence or absence of multivessel disease .
METHODS	We compared the 2 groups in terms of baseline characteristics , in-hospital management , and patient outcomes , and tested for treatment heterogeneity .
RESULTS	Multivessel disease was present in 369 ( 37 % ) patients .
RESULTS	Patients with multivessel disease had a greater rate of the primary composite end point of in-hospital death , recurrence of infarction , recurrent ischemia , shock , or heart failure at 30 days ( 18.2 % vs 10.8 % ; P < 0.001 ) .
RESULTS	An early invasive strategy was efficacious in both groups for the primary outcome .
RESULTS	In multivariable analysis adjusting for Global Registry of Acute Coronary Events ( GRACE ) risk score , there was no significant treatment heterogeneity ( all P interaction > 0.40 ) for the primary end point , or death/recurrence of infarction at 6 months and 1 year .
CONCLUSIONS	Multivessel disease is present in a significant proportion of STEMI patients treated with fibrinolysis and is associated with worse outcomes .
CONCLUSIONS	A strategy of early transfer and coronary intervention after fibrinolysis was beneficial regardless of the presence or absence of multivessel disease .

###25588784
BACKGROUND	Heavy menstrual bleeding ( HMB ) diminishes individual quality-of-life and poses substantial societal burden .
BACKGROUND	In HMB endometrium , inactivation of cortisol ( by enzyme 11 hydroxysteroid dehydrogenase type 2 ( 11HSD2 ) ) , may cause local endometrial glucocorticoid deficiency and hence increased angiogenesis and impaired vasoconstriction .
BACKGROUND	We propose that ` rescue ' of luteal phase endometrial glucocorticoid deficiency could reduce menstrual bleeding .
METHODS	DexFEM is a double-blind response-adaptive parallel-group placebo-controlled trial in women with HMB ( 108 to be randomised ) , with active treatment the potent oral synthetic glucocorticoid dexamethasone , which is relatively resistant to 11HSD2 inactivation .
METHODS	Participants will be aged over 18years , with mean measured menstrual blood loss ( MBL ) for two screening cycles 50mL .
METHODS	The primary outcome is reduction in MBL from screening .
METHODS	Secondary end points are questionnaire assessments of treatment effect and acceptability .
METHODS	Treatment will be for 5days in the mid-luteal phases of three treatment menstrual cycles .
METHODS	Six doses of low-dose dexamethasone ( ranging from 0.2 to 0.9 mg twice daily ) will be compared with placebo , to ascertain optimal dose , and whether this has advantage over placebo .
METHODS	Statistical efficiency is maximised by allowing randomisation probabilities to ` adapt ' at five points during enrolment phase , based on the response data available so far , to favour doses expected to provide greatest additional information on the dose-response .
METHODS	Bayesian Normal Dynamic Linear Modelling , with baseline MBL included as covariate , will determine optimal dose ( re reduction in MBL ) .
METHODS	Secondary end points will be analysed using generalised dynamic linear models .
METHODS	For each dose for all end points , a 95 % credible interval will be calculated for effect versus placebo .
BACKGROUND	Dexamethasone is widely used and hence well-characterised safety-wise .
BACKGROUND	Ethical approval has been obtained from Scotland A Research Ethics Committee ( 12/SS/0147 ) .
BACKGROUND	Trial findings will be disseminated via open-access peer-reviewed publications , conferences , clinical networks , public lectures , and our websites .
BACKGROUND	ClinicalTrials.gov NCT01769820 ; EudractCT 2012-003405-98 .

###25411033
BACKGROUND	Disrupting the physical structure of pulses by blending them or by using a digestive supplement ( - galactosidase ) to reduce intestinal discomfort could potentially negate the previously observed beneficial effects of whole pulses of lowering appetitive and glycemic responses because of more rapid digestion .
OBJECTIVE	We hypothesized that blended lentils , - galactosidase , or both increase postprandial appetite and blood glucose responses vs. whole lentils .
METHODS	Men and women [ n = 12 ; means SDs body mass index ( kg/m ( 2 ) ) : 23.3 3.1 ; aged 28 10 y ] consumed breakfast meals containing whole ( W ) , blended ( B ) , or no lentils [ control ( C ) ] , each with 3 - galactosidase or placebo capsules in a randomized , crossover , double-blind placebo-controlled trial .
METHODS	Between each test day there was a 3 - to 5-d washout period .
RESULTS	Mixed-model ANOVA showed effects of meal on postprandial appetite and glucose ( P = 0.0001-0 .031 ) .
RESULTS	The B meal resulted in higher postprandial appetite ratings than did the W meal but not the C meal for hunger , desire to eat , and prospective consumption ( = 0.4-0 .5 points ; P = 0.002-0 .044 ) .
RESULTS	Postprandial glucose concentration was 4.5 mg/dL lower for the B meal than for the C meal ( P < 0.0001 ) but did not differ from the W meal .
RESULTS	There were no main effects of - galactosidase , but there were meal - galactosidase interaction effects , with a greater postprandial desire to eat and lower postprandial fullness with the B meal than with the 2 other meals in the placebo condition but not in the - galactosidase condition .
CONCLUSIONS	Blending lentils increased appetite ( 6 % ) , but not glycemic response , compared with whole lentils , whereas - galactosidase did not .
CONCLUSIONS	Both B and W meals may be consumed ( with or without an - galactosidase supplement ) with little impact on appetite , without increasing glycemic response .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT02110511 .

###25037012
OBJECTIVE	To determine whether patients prefer topical anesthesia or subconjunctival anesthesia for intravitreal injection .
METHODS	Consecutive patients receiving bilateral simultaneous injections of anti-vascular endothelial growth factor agents were asked to participate in this within-patient , prospective , single-blinded , randomized , factorial study .
METHODS	Fifty-seven patients completed the study .
METHODS	Both eyes were treated with topical anesthesia .
METHODS	One eye was also injected with subconjunctival lidocaine .
METHODS	Anesthesia for the next treatment visit was based on patient preference at the conclusion of the study visit and at a 4-hour and 24-hour follow-up telephone call .
METHODS	Patients were allowed to change their anesthesia preference during the next three visits .
METHODS	The final endpoint for the study was anesthesia preference for ongoing intravitreal injections .
RESULTS	Fifty patients ( 88 % ) preferred subconjunctival anesthesia and seven patients ( 12 % ) preferred topical anesthesia for ongoing treatments .
RESULTS	( P = .0003 ) CONCLUSION : Given the choice , most patients prefer subconjunctival anesthesia to topical anesthesia for intravitreal injections .

###24325931
OBJECTIVE	To describe the experience and results from the roll-in phase of the Cardiovascular Outcomes with Renal Atherosclerotic Lesions ( CORAL ) study .
METHODS	The CORAL roll-in database was used to describe the baseline characteristics of the patients in the roll-in cohort , all of whom underwent renal artery stent placement ; to evaluate CORAL site performance ; to compare estimates of lesion ( stenosis ) severity made by site interventionalists with the central CORAL angiographic core laboratory readings ; and to report outcomes after renal artery stent placement .
METHODS	During the roll-in phase , 239 patients ( mean age , 70.2 y 9.0 ; 49 % male ) underwent renal artery stent procedures .
METHODS	Angiographic core laboratory analysis of renal arteriograms was done , and participants were followed at 1 month and 9 months .
RESULTS	Major angiographic complications were identified in 28 ( 13 % ) subjects .
RESULTS	Kidney function remained unchanged at the short ( 2-4 weeks ) follow-up interval .
RESULTS	Improvement in systolic blood pressure with use of distal embolic protection devices ( n = 161 ) did not show any clinical benefit over nonuse of such devices ( n = 78 ) in this small series .
RESULTS	At 9 months , there were significantly more endpoints reported by site in subjects with bilateral renal artery stenosis ( P = .01 ) and prior history of stroke ( P = .03 ) .
CONCLUSIONS	In the roll-in phase of the CORAL study , a significant number of angiographic complications were identified .
CONCLUSIONS	No effect was seen on estimated glomerular filtration rate after renal artery stent placement , but systolic blood pressure decreased significantly .

###24742322
BACKGROUND	There is a strong reciprocal association between two highly prevalent public health problems : intimate partner violence and heavy drinking , both of which remain major sources of morbidity and mortality .
BACKGROUND	Brief interventions in the Emergency Department setting have been found to be effective in reducing alcohol-related injury but neither classic intimate partner violence nor substance abuse interventions have adequately integrated assessment and treatment for these co-occurring conditions .
BACKGROUND	The overall goal of this study is to determine whether a motivational intervention delivered at the time of an Emergency Department visit will reduce heavy drinking and improve the safety of women experiencing intimate partner violence .
METHODS	We are completing data collection for a randomized controlled trial enrolling 600 female patients , age 18-64 , presenting to one of two urban Emergency Departments , who self-disclose both problem drinking and intimate partner violence .
METHODS	Eligible patients are randomized to a brief manual-guided motivational intervention , and a phone booster at 10 days .
METHODS	The intervention , which is delivered by masters-level therapists during the Emergency Department visit , is recorded and monitored for fidelity .
METHODS	Primary outcomes are episodes of heavy drinking and incidents of intimate partner violence , assessed weekly by Interactive Voice Response System for 12 weeks and at 3 , 6 and 12 months by interviewers blinded to group assignment .
METHODS	To identify the impact of assessment alone , we included a no-contact control group assessed only once at 3 months .
METHODS	Secondary outcomes include violence severity , changes in the Composite Abuse Scale and alcohol quantity/frequency , along with other health-related behaviors .
METHODS	The analysis will also explore the impact of likely mediators and moderators of the intervention .
CONCLUSIONS	While screening and intervention for intimate partner violence is now recommended for women of child bearing age in health care settings , there is a need for rigorous evaluations of what works for whom .
CONCLUSIONS	Upon completion , we will have high-quality evidence regarding the effectiveness of a low-intensity , brief motivational intervention , delivered by social workers in the Emergency Department setting , for decreasing episodes of heavy drinking and intimate partner violence .
CONCLUSIONS	Ultimately , this is a model could be generalizable to other acute health care settings .
BACKGROUND	ClinicalTrials.gov
BACKGROUND	NCT01207258 .

###25154739
BACKGROUND	Phytotherapy has been used to treat patients with lower urinary tract symptoms ( LUTS ) .
BACKGROUND	We evaluated the efficacy and tolerability of combination therapy between Serenoa Repens ( SeR ) , Lycopene ( Ly ) , and Selenium ( Se ) + tamsulosin versus single therapies .
METHODS	PROCOMB trial ( ISRCTN78639965 ) was a randomized double-blinded , double-dummy multicenter study of 225 patients between 55 and 80 years old , PSA4ng/ml , IPSS 12 , prostate volume 60 cc , Qmax 15ml/sec , postvoid residual urine ( PVR ) < 150ml .
METHODS	Participants were randomized group A ( SeR-Se-Ly ) , group B ( tamsulosin 0.4 mg ) , group C ( SeR-Se-Ly + tamsulosin 0.4 mg ) .
METHODS	The primary endpoints of the study were the reduction of IPSS , PVR , and increase of Qmax in group C versus monotherapy groups .
RESULTS	The decrease for combination therapy was significantly greater versus group A ( P < 0.05 ) and group B ( P < 0.01 ) for IPSS and versus group A ( P < 0.01 ) for PVR from baseline to 6 months .
RESULTS	A greater decrease in IPSS was observed for Group C versus group A ( P < 0.01 ) and increase in Qmax versus group B ( P < 0.01 ) , from 6 months to 12 months .
RESULTS	At one year , the changes of IPSS and Qmax were greater for Group C versus monotherapies ( each comparison < 0.05 ) .
RESULTS	The proportions of men with a decrease of at least three points ( each comparison P < 0.05 ) and decrease of 25 % for IPSS ( each comparison P < 0.01 ) were greater for Group C.
CONCLUSIONS	SeR-Se-Ly + tamsulosin therapy is more effective than single therapies in improving IPSS and increasing Qmax in patients with LUTS .

###24935272
OBJECTIVE	Severe alcoholic hepatitis has high short-term mortality .
OBJECTIVE	The aim of this study was to test the hypothesis that treatment of patients with alcoholic hepatitis with granulocyte colony-stimulating factor ( G-CSF ) might mobilize bone marrow-derived stem cells and promote hepatic regeneration and thus improve survival .
METHODS	Forty-six patients with severe alcoholic hepatitis were prospectively randomized in an open study to standard medical therapy ( SMT ) plus G-CSF ( group A ; n = 23 ) at a dose of 5g/kg subcutaneously every 12h for 5 consecutive days or to SMT alone ( group B ; n = 23 ) at a tertiary care center .
METHODS	We assessed the mobilization of CD34 ( + ) cells on day 6 , Child-Turcotte-Pugh ( CTP ) , model for end-stage liver disease ( MELD ) , and modified Maddrey 's discriminant function ( mDF ) scores , and survival until day 90 .
RESULTS	There was a statistically significant increase in the number of CD34 ( + ) cells in peripheral blood in group A as compared with group B ( P = 0.019 ) after 5 days of G-GSF therapy .
RESULTS	There was a significant reduction in median change % in CTP , MELD , and mDF at 1 , 2 , and 3 months in group A as compared with group B ( P < 0.05 ) .
RESULTS	There was marked improvement in survival in group A as compared with group B ( 78.3 % vs. 30.4 % ; P = 0.001 ) at 90 days .
CONCLUSIONS	G-CSF is safe and effective in the mobilization of hematopoietic stem cells and improves liver function as well as survival in patients with severe alcoholic hepatitis .

###24561207
BACKGROUND	Multiple studies have been conducted that demonstrate the superiority of patch angioplasty over primary closure for carotid endarterectomy ( CEA ) .
BACKGROUND	Patch angioplasty with polytetrafluorethylene patches ( ACUSEAL ) have shown results comparable to patch angioplasty with saphenous vein and polyester patches .
BACKGROUND	This is a prospective randomized study to compare the clinical outcomes of CEA using ACUSEAL versus bovine pericardium patching ( Vascu-Guard ) .
METHODS	Two hundred patients were randomized ( 1:1 ) to either ACUSEAL or Vascu-Guard patching .
METHODS	Demographic data/clinical characteristics were collected .
METHODS	Intraoperative hemostasis times and the frequency of reexploration for neck hematoma were recorded .
METHODS	All patients received immediate and 1-month postoperative duplex ultrasound studies , which were repeated at 6-month intervals .
METHODS	A Kaplan-Meier analysis was used to estimate the risk of restenosis and the stroke-free survival rates .
RESULTS	The demographics were similar in both groups , except for a higher incidence of current smokers in the ACUSEAL group and more patients with congestive heart failure in the Vascu-Guard group ( P = 0.02 and 0.03 , respectively ) .
RESULTS	The mean operative internal carotid artery diameter and the mean arteriotomy length were similar in both groups .
RESULTS	The mean hemostasis time was 4.90 min for ACUSEAL patching vs. 3.09 min for Vascu-Guard ( P = 0.027 ) ; however , the mean operative times were similar for both groups ( ACUSEAL 2.09 hr vs. Vascu-Guard 2.16 hr , P = 0.669 ) .
RESULTS	The incidence of reexploration for neck hematoma was higher in the Vascu-Guard group ; 6.12 % vs. 1.03 % ( P = 0.1183 ) .
RESULTS	The incidence of perioperative ipsilateral neurologic events was 3.09 % for ACUSEAL patching vs. 1.02 % for Vascu-Guard patching ( P = 0.368 ) .
RESULTS	The mean follow-up period was 15 months .
RESULTS	The respective freedom from 70 % carotid restenosis at 1 , 2 , and 3 years were 100 % , 100 % , and 100 % for ACUSEAL patching vs. 100 % , 98 % , and 98 % for Vascu-Guard patching ( P = 0.2478 ) .
RESULTS	The ipsilateral stroke-free rates at 1 , 2 , and 3 years were 96 % for ACUSEAL and 99 % for Vascu-Guard patching .
CONCLUSIONS	Although CEA patching with ACUSEAL versus Vascu-Guard differed in hemostasis time , the frequency of reexploration for neck hematomas was more frequent in the pericardial patch group ; however , only 1 patient had documented suture line bleeding and the surgical reexploration rate is not likely to be patch related .
CONCLUSIONS	There were not any significant differences in perioperative/late neurologic events and late restenosis in the 2 groups .

###25512674
BACKGROUND	Uptake of chlamydia screening by men in England has been substantially lower than by women .
BACKGROUND	Non-traditional settings such as sports clubs offer opportunities to widen access .
BACKGROUND	Involving people who are not medically trained to promote screening could optimise acceptability .
METHODS	We developed two interventions to explore the acceptability and feasibility of urine-based sexually transmitted infection ( STI ) screening interventions targeting men in football clubs .
METHODS	We tested these interventions in a pilot cluster randomised control trial .
METHODS	Six clubs were randomly allocated , two to each of three trial arms : team captain-led and poster STI screening promotion ; sexual health adviser-led and poster STI screening promotion ; and poster-only STI screening promotion ( control/comparator ) .
METHODS	Primary outcome was test uptake .
RESULTS	Across the three arms , 153 men participated in the trial and 90 accepted the offer of screening ( 59 % , 95 % CI 35 % to 79 % ) .
RESULTS	Acceptance rates were broadly comparable across the arms : captain-led : 28/56 ( 50 % ) ; health professional-led : 31/46 ( 67 % ) ; and control : 31/51 ( 61 % ) .
RESULTS	However , rates varied appreciably by club , precluding formal comparison of arms .
RESULTS	No infections were identified .
RESULTS	Process evaluation confirmed that interventions were delivered in a standardised way but the control arm was unintentionally ` enhanced ' by some team captains actively publicising screening events .
CONCLUSIONS	Compared with other UK-based community screening models , uptake was high but gaining access to clubs was not always easy .
CONCLUSIONS	Use of sexual health advisers and team captains to promote screening did not appear to confer additional benefit over a poster-promoted approach .
CONCLUSIONS	Although the interventions show potential , the broader implications of this strategy for UK male STI screening policy require further investigation .

###24346752
BACKGROUND	Agitation is a major problem in acute schizophrenia .
BACKGROUND	Only a few studies have tested antipsychotic agents in severely agitated patients , mainly because of legal issues .
BACKGROUND	Furthermore , most studies were limited to the first 24 hours .
BACKGROUND	We aimed to investigate the efficacy of oral haloperidol , risperidone , and olanzapine in reducing psychotic agitation in severely agitated patients with schizophrenia or schizophreniform or schizoaffective disorder over 96 hours using a prospective , randomized , rater-blinded , controlled design within a naturalistic treatment regimen .
METHODS	In total , 43 severely agitated patients at acute care psychiatric units were enrolled .
METHODS	Participants were randomly assigned to receive either daily haloperidol 15 mg , olanzapine 20 mg , or risperidone 2 to 6 mg over 5 days .
METHODS	Positive and Negative Syndrome Scale psychotic agitation subscale score was the primary outcome variable .
METHODS	A mixed-model analysis was applied .
RESULTS	All drugs were effective for rapid tranquilization within 2 hours .
RESULTS	Over 5 days , the course differed between agents ( P < 0.001 ) , but none was superior .
RESULTS	Dropouts occurred only in the risperidone and olanzapine groups .
RESULTS	Men responded better to treatment than did women during the initial 2 hours ( P = 0.046 ) as well as over the 5-day course ( P < 0.001 ) .
RESULTS	No difference between drug groups was observed regarding diazepam or biperiden use .
CONCLUSIONS	Oral haloperidol , risperidone , and olanzapine seem to be suitable for treating acute severe psychotic agitation in schizophrenia spectrum disorders .
CONCLUSIONS	Response to oral antipsychotics demonstrated a gender effect with poorer outcome in women throughout the study .

###25842934
BACKGROUND	Early dysfunction of transplanted kidney is a serious complication that can lead to the premature loss of transplant .
BACKGROUND	Ischemic and reperfusion injury of donor kidney leads to the disturbance of the function of the graft , which is a form of post-transplantation acute kidney injury that causes the relevance of search of early markers for diagnosis .
OBJECTIVE	Evaluation of the diagnostic value of determination in the urine neutrophilgelatinase-associated lipocalin ( u-NGAL ) in patients in the early period after kidney transplantation .
METHODS	An open , randomized , retrospective comparative study of 80 patients , who underwent kidney transplantation from a living human-related donor ( group 1 , 50 patients ) and from donor with brain death documentation ( group 2 , 30 patients ) was carried out .
METHODS	In 20 patients of the second group ( group 2a ) rapid recovery of graft function was observed , and in 10 patients ( group 2b ) -- delayed graft recovery as a result of postischemic acute kidney injury .
METHODS	During the first five post-transplantation days investigated biochemical analysis of blood and urine , as well as the marker u-NGAL .
RESULTS	Because of kidney transplantation was performed to the patients with end-stage chronic renal failure , high values of urea and creatinine in the blood samples during the first postoperative days were noted , that reflected the severity of the preoperative state of the patients .
RESULTS	In the patients , who underwent human-related kidney transplantation , a more favorable picture of the investigated laboratory parameters was seen .
RESULTS	Values of u-NGAL in this group in the early post-transplant period were normal , which attested to the absence of significant ischemic injury of transplanted kidney .
RESULTS	In 30 patients with cadaver kidney transplantation average u-NGAL value during the first post-transplant day was 14-times fold exceeded normal range ( 160 ng/ml ) , while in 50 patients of the group with human-related transplantation -- only 2 times .
RESULTS	In the first day in group 2a average u-NGAL value decreased to normal , while in group 2b , where renal replacement therapy was carried out from the first day , remained extremely high ( more than 2000 ng/ml , p < 0.001 to compare with other two groups ) during all 5 days of investigation .
RESULTS	Conducting of hemodialysis sessions during the first week was required in 10 patients of group 2b , on the 2nd week -- 9 patients , on the 3 and 4 week in 5 patients 5 , and on the fifth week -- in 3 patients .
CONCLUSIONS	Due to prolonged period of ischemia in kidney transplantation from a donor with established brain death the level of u-NGAL in these patients was significantly higher than in the kidneys transplantation from living human-related donor .
CONCLUSIONS	In patients after transplantation dynamics of u-NGAL allows to identify patients with delayed graft function recovery and the need for renal replacement therapy already in the early postoperative period .

###24555909
BACKGROUND	Ultrasonic surgery can dissect structures and divide vessels by the effect produced by vibrations in the tissues .
BACKGROUND	It is believed to be less traumatic than the more commonly used monopolar electrosurgery ( ELC ) .
BACKGROUND	Laparoscopic techniques are being used increasingly in surgical conditions complicated by peritonitis .
BACKGROUND	This randomized study compares the acute inflammatory and systemic immune response after laparoscopic cholecystectomy in patients with acute calculous cholecystitis , complicated by peritonitis , performed using either ultrasonic energy or ELC .
METHODS	Forty-three patients , scheduled for laparoscopic cholecystectomy , were randomly assigned to treatment using either an ultrasonic device ( UC ) ( n = 22 patients ) or ELC ( n = 21 patients ) .
METHODS	Bacteremia , endotoxemia , white blood cells , the peripheral lymphocyte subpopulation , human leukocyte antigen-DR ( HLA-DR ) , neutrophil-elastase , interleukin-6 and -1 , and C-reactive protein ( CRP ) were investigated .
RESULTS	Significantly higher concentration of systemic endotoxin , neutrophil , neutrophil-elastase , interleukin-6 and -1 , and CRP were detected intraoperatively and/or postoperatively in the ELC group of patients in comparison with the UC group ( P < .05 ) .
RESULTS	A statistically significant change in HLA-DR expression was recorded on postoperative Day 1 as a reduction of this antigen expressed on the monocyte surface in patients from the ELC group ; no changes were noted in UC patients ( P < .05 ) .
RESULTS	We recorded 4 patients ( 22.2 % ) who developed an intraabdominal abscess in the ELC group and 1 ( 4 % ) in the UC group ( P < .05 ) .
CONCLUSIONS	Laparoscopic cholecystectomy after biliary peritonitis , conducted by ELC , increased the incidence of bacteremia and systemic inflammation compared with the UC group .
CONCLUSIONS	Early enhanced postoperative systemic inflammation may cause lower transient immunologic defense in the ELC group , leading to enhanced sepsis .

###25378467
BACKGROUND	Elevated serum digoxin concentration can cause toxicity , including death .
BACKGROUND	Dronedarone increases digoxin concentration by P-glycoprotein interaction .
BACKGROUND	In Permanent Atrial Fibrillation Outcome Study Using Dronedarone On Top Of Standard Therapy Trial ( PALLAS ) , dronedarone was associated with both increased cardiovascular death and heart failure in patients with permanent atrial fibrillation .
BACKGROUND	The present analysis examines whether the dronedarone-digoxin interaction might explain these adverse outcomes .
RESULTS	Subgroup analysis was performed to compare outcomes of patients on digoxin at baseline or not .
RESULTS	In PALLAS , 1619 patients were randomized to dronedarone and 1617 to placebo , of whom 544 ( 33.6 % ) and 526 ( 32.5 % ) were receiving digoxin , respectively .
RESULTS	Median ( Q1 , Q3 ) digoxin serum concentration on day 7 was 1.1 ( 0.7,1.5 ) ng/mL on dronedarone and 0.7 ( 0.5,1.1 ) ng/mL on placebo ( P < 0.001 ) .
RESULTS	Among patients on digoxin , there were 15 ( 8.6 % / year ) cardiovascular deaths on dronedarone and 2 ( 1.2 % / year ) on placebo ( adjusted hazard ratio , 7.31 ; 95 % confidence interval , 1.66-32 .20 ; P = 0.009 ) .
RESULTS	Among patients not on digoxin , there were 6 cardiovascular deaths on dronedarone ( 1.7 % / year ) and 8 on placebo ( 2.2 % / year ; adjusted hazard ratio , 0.67 ; 95 % confidence interval , 0.23-1 .95 ; P = 0.46 ; interaction P value 0.01 ) .
RESULTS	In patients on digoxin , there were 11 arrhythmic deaths on dronedarone and none on placebo ; and in patients not on digoxin , there were 2 arrhythmic deaths on dronedarone and 4 on placebo ( P value for interaction 0.002 ) .
RESULTS	There was no interaction between baseline digoxin use and the adverse effect of dronedarone on heart failure events .
CONCLUSIONS	In PALLAS , there was a strong effect of concurrent digoxin use on the adverse effect of dronedarone on cardiovascular death , but not on occurrence of heart failure .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01151137 .

###24957485
BACKGROUND	Activation of the ileal brake , by infusing lipid directly into the distal part of the small intestine , alters gastrointestinal ( GI ) motility and inhibits food intake .
BACKGROUND	The ileal brake effect on eating behavior of the other macronutrients is currently unknown .
OBJECTIVE	The objective of this study was to investigate the effects of ileal infusion of sucrose and casein on food intake , release of GI peptides , gastric emptying rate and small-bowel transit time with safflower oil as positive control .
METHODS	This randomized , single-blind , crossover study was performed in 13 healthy subjects ( 6 male ; mean age 26.42.9 years ; mean body mass index 22.80.4 kgm ( -2 ) ) who were intubated with a naso-ileal catheter .
METHODS	Thirty minutes after the intake of a standardized breakfast , participants received an ileal infusion , containing control ( ( C ) saline ) , safflower oil ( ( HL ) 51.7 kcal ) , low-dose casein ( ( LP ) 17.2 kcal ) or high-dose casein ( ( HP ) 51.7 kcal ) , low-dose sucrose ( ( LC ) 17.2 kcal ) and high-dose sucrose ( ( HC ) 51.7 kcal ) , over a period of 90min .
METHODS	Food intake was determined during an ad libitum meal .
METHODS	Visual analogue score questionnaires for hunger and satiety and blood samples were collected at regular intervals .
RESULTS	Ileal infusion of lipid , protein and carbohydrate resulted in a significant reduction in food intake compared with control ( HL : 464.390.7 kcal , P < 0.001 ; HP : 458.078.6 kcal , P < 0.005 ; HC : 399.057.0 kcal , P < 0.0001 vs control : 586.770.2 kcal , P < 0.001 , respectively ) .
RESULTS	A reduction in energy intake was still apparent when the caloric amount of infused nutrients was added to the amount eaten during the ad libitum meal.Secretion of cholecystokinin and peptide YY but not of glucagon-like peptide-1 ( 7-36 ) was increased during ileal perfusion of fat , carbohydrates and protein .
RESULTS	During ileal perfusion of all macronutrients , a delay in gastric emptying and intestinal transit was observed , but differences were not significant compared with control .
CONCLUSIONS	Apart from lipids , also sucrose and casein reduce food intake on ileal infusion , thereby activating the ileal brake .
CONCLUSIONS	In addition to food intake , also satiety and GI peptide secretion were affected .

###25263215
OBJECTIVE	To determine if the glucagon-like peptide-1 ( GLP-1 ) receptor agonist albiglutide , once weekly , impairs counter-regulatory responses during hypoglycaemia .
METHODS	We conducted a randomized , double-blind , parallel , placebo-controlled study in subjects with type 2 diabetes mellitus .
METHODS	A single dose of albiglutide 50mg ( n = 22 ) or placebo ( n = 22 ) was administered on day 1 .
METHODS	Glucose was clamped on day 4 ( to coincide with the approximate albiglutide maximum plasma concentration ) at 9.0 , 5.0 , 4.0 , 3.3 and 2.8 mmol/l ( 162 , 90 , 72 , 59.4 and 50.4 mg/dl ) , with a post-clamp recovery period to 3.9 mmol/l ( 70mg/dl ) .
METHODS	Hormone measurements were made at each plateau and adverse events ( AEs ) were recorded .
RESULTS	The counter-regulatory hormones glucagon , epinephrine , norepinephrine , growth hormone and cortisol were appropriately suppressed when plasma glucose levels were > 4.0 mmol/l ( > 72mg/dl ) , but increased in the albiglutide and placebo groups with glucose levels < 3.3 mmol/l ( < 59.4 mg/dl ) in response to hypoglycaemia .
RESULTS	The area under the curve geometric mean ratios ( albiglutide : placebo ) , calculated from the clamped plateau of 4.0 mmol/l ( 72mg/dl ) to the glucose recovery point , were not significantly different for any of the counter-regulatory hormones .
RESULTS	When plasma glucose levels were > 5.0 mmol/l ( > 90mg/dl ) , albiglutide increased pancreatic - cell secretion of C-peptide in a glucose-dependent manner to a greater extent than did placebo , and it was suppressed in each group when levels were < 4.0 mmol/l ( < 72mg/dl ) .
RESULTS	No significant difference between groups was observed in the recovery time to glucose level 3.9 mmol/l ( 70mg/dl ) .
RESULTS	There were no clinically relevant differences in AEs or other safety variables .
CONCLUSIONS	A single 50-mg dose of albiglutide was well tolerated and did not impair the counter-regulatory response to hypoglycaemia .
CONCLUSIONS	These data provide mechanistic evidence supporting the low intrinsic hypoglycaemic potential of albiglutide .

###24923535
OBJECTIVE	A step stool is an ordinary device to improve the quality of chest compression ( CC ) during in-hospital cardiopulmonary resuscitation ( CPR ) .
OBJECTIVE	We investigated the effect of an inclined step stool on the quality of CC during CPR on a hospital bed .
METHODS	We conducted a randomized crossover study of simulation using a manikin .
METHODS	Two different methods of CC were performed and compared : CC using a flat stool and CC using an inclined ( 20 ) stool .
METHODS	Each session of CC was performed for 2 minutes using a metronome at a rate of 110 beats per minute .
METHODS	The primary outcome was the depth of CC .
METHODS	The adequate CC rate , duty cycle , rate of incomplete recoil , and the angle between the arm of the participants and the bed were also measured .
RESULTS	The median value of the mean depth of CC was 50.5 mm ( 45.0-57 .0 mm ) in the flat stool group and 54.5 mm ( 47.0-58 .3 mm ) in the inclined stool group ( P = .014 ) .
RESULTS	The adequate CC rate was significantly higher in the inclined stool group ( 84.2 % [ 37.6 % -99.1 % ] vs 57.0 % [ 15.2 % -95.0 % ] ; P = .016 ) .
RESULTS	The duty cycle and the rate of incomplete recoil were comparable between the 2 groups .
RESULTS	The angles between the arm of the participants and the bed were more vertical in the inclined stool group ( 84.0 5.2 vs 81.0 4.8 ; P = .014 ) .
CONCLUSIONS	Using an inclined stool resulted in an improvement in the depth of CC and the adequate CC rate without increasing the rate of incomplete chest recoil .

###24850106
BACKGROUND	Interlaminar epidural steroid injection is a well-established intervention for the treatment of radicular pain .
BACKGROUND	Pain is commonly reported during the injection into the epidural space ; this provocation is typically either concordant or discordant with the patient 's baseline pain .
BACKGROUND	It is not well known how this provocation pain relates to treatment outcomes .
OBJECTIVE	To determine the relationship between concordant versus discordant provocation during interlaminar epidural steroid injection and its effects on pain reduction at follow-up .
METHODS	Secondary analysis of a single center , prospective randomized double-blind study .
METHODS	Interlaminar epidural steroid injections under fluoroscopic guidance were performed on 48 patients with radicular lumbosacral pain .
METHODS	After injection with 80 mg methylprednisolone and 2 mL of normal saline at a single level , patients were asked to report if pain was provoked , and whether the pain was concordant or discordant with their baseline pain .
METHODS	The primary outcome measure was self-rated percentage of pain reduction from baseline at 2-week follow-up .
METHODS	Secondary outcomes included improvement in activity level and decreased analgesic consumption .
RESULTS	Provocation was observed in 37 out of 48 patients ( 77 % ) .
RESULTS	This was further classified as concordant ( 22/37 , 60 % ) or discordant ( 15/37 , 40 % ) pain .
RESULTS	The concordant group achieved a significant decrease in self-reported pain as compared to the discordant group at 2-week follow-up ( 61 % , t = 2.45 , P < 0.01 ) .
RESULTS	There were also significantly more patients in the concordant group who reported 75 % pain reduction as compared to the discordant group ( X = 6.44 , df ( 1 ) , P < 0.05 ) .
RESULTS	There were no significant differences between concordant and discordant groups in regard to improvements in activity level ( X = 2.56 ) and decreased analgesic use ( X = 3.28 ) .
CONCLUSIONS	The secondary analysis did not examine long-term outcomes .
CONCLUSIONS	The concordant group demonstrated significantly higher pain reduction as compared to the discordant group .
CONCLUSIONS	There were no significant differences between the 2 groups in terms of improved function or reduced analgesic requirements .
CONCLUSIONS	Concordant provocation during interlaminar epidural injection may be a predictor of outcome .

###25153503
BACKGROUND	Previous small studies have indicated that commonly prescribed drugs may be associated with microscopic colitis ( MC ) .
BACKGROUND	With an increasing incidence of MC , it is important to explore the association between exposure to proton pump inhibitors ( PPIs ) , nonsteroidal anti-inflammatory drugs , statins , and selective serotonin reuptake inhibitors and MC in a larger setting .
METHODS	Case-control study based on nationwide Danish registries .
METHODS	The study included all patients with MC diagnosis during the period 2005 to 2011 .
METHODS	One hundred sex - and age-matched controls per case were randomly selected among the Danish population .
METHODS	Prescriptions were recorded in a Prescription Register in the year before the first recorded MC diagnosis .
METHODS	Effect measure is the adjusted odds ratio ( OR ) of collagenous colitis ( CC ) and lymphocytic colitis ( LC ) according to prescriptions of PPIs , nonsteroidal anti-inflammatory drugs , statins , and selective serotonin reuptake inhibitors .
METHODS	Within the control group , we identified a subgroup with MC-free colonic biopsies .
RESULTS	We identified 3474 patients with CC and 2277 with LC and found a positive association between redemption of prescriptions for PPIs and both CC ( OR = 7.04 ; 95 % confidence interval , 6.55-7 .56 ) and LC ( OR = 3.37 ; 95 % confidence interval , 3.08-3 .69 ) .
RESULTS	Among patients with MC-free colon biopsies in the control group , the association between PPIs and CC was strongly positive ( OR = 3.47 ; 95 % confidence interval , 3.08-3 .89 ) .
RESULTS	Adding this parameter to the model attenuated all of the associations , but they remained positive for PPIs versus CC and selective serotonin reuptake inhibitors versus LC .
CONCLUSIONS	We found positive associations between exposure to all 4 medication classes and MC .
CONCLUSIONS	Variations in endoscopic frequency by drug category indicate a potential impact of bias .

###24835842
BACKGROUND	Antiretroviral therapy reduces the risk of tuberculosis , but tuberculosis is more common in people with HIV than in people without HIV .
BACKGROUND	We aimed to assess the effect of isoniazid preventive therapy on the risk of tuberculosis in people infected with HIV-1 concurrently receiving antiretroviral therapy .
METHODS	For this pragmatic randomised double-blind , placebo-controlled trial in Khayelitsha , South Africa , we randomly assigned ( 1:1 ) patients to receive either isoniazid preventive therapy or a placebo for 12 months ( could be completed during 15 months ) .
METHODS	Randomisation was done with random number generator software .
METHODS	Participants , physicians , and pharmacy staff were masked to group assignment .
METHODS	The primary endpoint was time to development of incident tuberculosis ( definite , probable , or possible ) .
METHODS	We excluded tuberculosis at screening by sputum culture .
METHODS	We did a modified intention-to-treat analysis and excluded all patients randomly assigned to groups who withdrew before receiving study drug or whose baseline sputum culture results suggested prevalent tuberculosis .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00463086 .
RESULTS	1329 participants were randomly assigned to receive isoniazid preventive therapy ( n = 662 ) or placebo ( n = 667 ) between Jan 31 , 2008 , and Sept 31 , 2011 , and contributed 3227 person-years of follow-up to the analysis .
RESULTS	We recorded 95 incident cases of tuberculosis ; 37 were in the isoniazid preventive therapy group ( 23 per 100 person-years , 95 % CI 16-31 ) , and 58 in the placebo group ( 36 per 100 person-years , 28-47 ; hazard ratio [ HR ] 063 , 95 % CI 041-094 ) .
RESULTS	Study drug was discontinued because of grade 3 or 4 raised alanine transaminase concentrations in 19 of 662 individuals in the isoniazid preventive therapy group and ten of the 667 individuals in the placebo group ( risk ratio 19 , 95 % CI 090-409 ) .
RESULTS	We noted no evidence that the effect of isoniazid preventive therapy was restricted to patients who were positive on tuberculin skin test or interferon gamma release assay ( adjusted HR for patients with negative tests 043 [ 021-086 ] and 043 [ 020-096 ] ; for positive tests 086 [ 037-200 ] and 055 [ 026-124 ] , respectively ) .
CONCLUSIONS	Without a more predictive test or a multivariate algorithm that predicts benefit , isoniazid preventive therapy should be recommended to all patients receiving antiretroviral therapy in moderate or high incidence areas irrespective of tuberculin skin test or interferon gamma release assay status .
BACKGROUND	Department of Health of South Africa , the Wellcome Trust , Mdecins Sans Frontires , European and Developing Countries Clinical Trials Partnership , Foundation for Innovation and New Diagnostics , the European Union , and Hasso Plattner ( Institute of Infectious Diseases and Molecular Medicine , University of Cape Town ) .

###25332467
BACKGROUND	Utilization of energy-dense lipid fuels is critical to the rapid development and growth of neonates .
OBJECTIVE	To increase efficiency of milk fat utilization by newborn pigs , the effect of clofibrate on in vivo and in vitro long-chain fatty acid ( LCFA ) oxidation was evaluated .
METHODS	Newborn male pigs were administered 5 mL of vehicle ( 2 % Tween 80 ) with or without clofibrate ( 75 mg/kg body weight ) once daily via i.g. gavage for 4 d. Total LCFA oxidative capacity was measured in respiration chambers after gastric infusion ( n = 5 per treatment ) with isoenergetic amounts of [ 1 - ( 14 ) C ] triglycerides ( TGs ) , either oleic acid ( 18:1 n-9 ) TG [ 3.02 mmol/kg body weight ( BW ) ( 0.75 ) ] or erucic acid ( 22:1 n-9 ) TG ( 2.46 mmol/kg BW ( 0.75 ) ) .
METHODS	Total expired ( 14 ) CO2 was collected and quantified at 20-min intervals over 24 h. Hepatic in vitro LCFA oxidation was determined simultaneously using [ 1 - ( 14 ) C ] oleic acid and erucic acid substrates .
RESULTS	The in vivo 24-h accumulative [ 1 - ( 14 ) C ] TG oxidation ( percentage of energy intake/kg BW ( 0.75 ) ) tended to increase with clofibrate supplementation ( P = 0.10 ) , although there was no difference in the peak or mean utilization rate .
RESULTS	The maximal extent of oleic acid TG oxidation was 1.6-fold that of erucic acid TG ( P < 0.006 ) .
RESULTS	Hepatic in vitro LCFA oxidation increased 61 % with clofibrate ( P < 0.0008 ) .
RESULTS	The increase in mitochondria was 4-fold greater than in peroxisomes .
RESULTS	The relative abundance of mRNA increased 2 - to 3-fold for hepatic peroxisome proliferator-activated receptor and its target genes ( fatty acyl-coenzyme A oxidase and carnitine palmitoyltransferase ) in the pigs that were administered clofibrate ( P < 0.04 ) .
CONCLUSIONS	Clofibrate may improve in vivo LCFA oxidative utilization in neonatal pigs .

###24657685
OBJECTIVE	This study sought to characterize major bleeding on the basis of the components of the major bleeding definition , to explore major bleeding by location , to define 30-day mortality after a major bleeding event , and to identify factors associated with major bleeding .
BACKGROUND	Apixaban was shown to reduce the risk of major hemorrhage among patients with atrial fibrillation in the ARISTOTLE ( Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation ) trial .
METHODS	All patients who received at least 1 dose of a study drug were included .
METHODS	Major bleeding was defined according to the criteria of the International Society on Thrombosis and Haemostasis .
METHODS	Factors associated with major hemorrhage were identified using a multivariable Cox model .
RESULTS	The on-treatment safety population included 18,140 patients .
RESULTS	The rate of major hemorrhage among patients in the apixaban group was 2.13 % per year compared with 3.09 % per year in the warfarin group ( hazard ratio [ HR ] 0.69 , 95 % confidence interval [ CI ] : 0.60 to 0.80 ; p < 0.001 ) .
RESULTS	Compared with warfarin , major extracranial hemorrhage associated with apixaban led to reduced hospitalization , medical or surgical intervention , transfusion , or change in antithrombotic therapy .
RESULTS	Major hemorrhage followed by mortality within 30 days occurred half as often in apixaban-treated patients than in those receiving warfarin ( HR 0.50 , 95 % CI : 0.33 to 0.74 ; p < 0.001 ) .
RESULTS	Older age , prior hemorrhage , prior stroke or transient ischemic attack , diabetes , lower creatinine clearance , decreased hematocrit , aspirin therapy , and nonsteroidal anti-inflammatory drugs were independently associated with an increased risk .
CONCLUSIONS	Apixaban , compared with warfarin , was associated with fewer intracranial hemorrhages , less adverse consequences following extracranial hemorrhage , and a 50 % reduction in fatal consequences at 30 days in cases of major hemorrhage .

###24721024
OBJECTIVE	Dislocation of the shoulder joint is one of the most common dislocations .
OBJECTIVE	The reduction procedure is a painful procedure .
OBJECTIVE	In this study , 2 different treatment groups were compared for pain control during shoulder dislocation reduction .
OBJECTIVE	It was aimed to evaluate the differences between the groups in reduction , success , length of hospital stay , complications , side effects , patient-physician satisfaction , and ease of application .
METHODS	The study was planned to be prospective and randomized .
METHODS	As procedural sedation analgesia ( SA ) , titration of ketamine 1 to 2 mg/kg was administered intravenously to group 1 .
METHODS	Suprascapular nerve block ( SNB ) was applied under ultrasound guidance ( USG ) to group 2 .
METHODS	Conformity to normal distribution of variables was examined with the Kolmogorov-Smirnov test .
METHODS	The 2 test and Fisher test were used to evaluate differences between the groups in categorical variables and the Mann-Whitney U test , and a value of P < .05 was accepted as statistically significant .
RESULTS	The study comprised a total of 41 patients ; 20 in the group 1 and 21 in the group 2 .
RESULTS	No statistically significant difference was determined between the groups in terms of age ( P = .916 ) , sex ( P = .972 ) , reduction success ( P = .540 ) , and patient-physician satisfaction ( P = .198 ) .
RESULTS	The time spent in the emergency department ( ED ) by patients in the SA group was signficantly longer compared with the SNB group .
RESULTS	No side effects were observed in the SNB group .
CONCLUSIONS	Suprascapular nerve block , which can be easily applied under USG in the ED , can be evaluated as a good alternative to SA in the reduction of shoulder dislocations .

###25099540
BACKGROUND	Eicosapentaenoic acid ( EPA ) plus docosahexaenoic acid ( DHA ) supplementation has beneficial cardiovascular effects , but postprandial influences of these individual fatty acids are unclear .
OBJECTIVE	The primary objective was to determine the vascular effects of EPA + DHA compared with DHA only during postprandial lipemia relative to control high-oleic acid meals ; the secondary objective was to characterize the effects of linoleic acid-enriched high-fat meals relative to the control meal .
METHODS	We conducted a randomized , controlled , double-blind crossover trial of 4 high-fat ( 75-g ) meals containing 1 ) high-oleic acid sunflower oil ( HOS ; control ) , 2 ) HOS + fish oil ( FO ; 5 g EPA and DHA ) , 3 ) HOS + algal oil ( AO ; 5 g DHA ) , and 4 ) high-linoleic acid sunflower oil ( HLS ) in 16 healthy men ( aged 35-70 y ) with higher than optimal fasting triacylglycerol concentrations ( mean SD triacylglycerol , 1.9 0.5 mmol/L ) .
RESULTS	Elevations in triacylglycerol concentration relative to baseline were slightly reduced after FO and HLS compared with the HOS control ( P < 0.05 ) .
RESULTS	The characteristic decrease from baseline in plasma nonesterified fatty acids after a mixed meal was inhibited after AO ( 0-3 h , P < 0.05 ) .
RESULTS	HLS increased the augmentation index compared with the other test meals ( P < 0.05 ) , although the digital volume pulse-reflection index was not significantly different .
RESULTS	Plasma 8-isoprostane F2 analysis revealed opposing effects of FO ( increased ) and AO ( reduced ) compared with the control ( P < 0.05 ) .
RESULTS	No differences in nitric oxide metabolites were observed .
CONCLUSIONS	These data show differential postprandial 8-isoprostane F2 responses to high-fat meals containing EPA + DHA-rich fish oil compared with DHA-rich AO , but these differences were not associated with consistent effects on postprandial vascular function or lipemia .
CONCLUSIONS	More detailed analyses of polyunsaturated fatty acid-derived lipid mediators are required to determine possible divergent functional effects of single meals rich in either DHA or EPA .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01618071 .

###24763840
BACKGROUND	Clonidine is used with local anaesthetics to improve analgesia .
BACKGROUND	However , the improvement conferred when clonidine is used together with ropivacaine is controversial .
BACKGROUND	Thus , the present study aimed to evaluate the improvement in analgesia when clonidine is used together with ropivacaine for supraclavicular brachial plexus block .
METHODS	This was a prospective , randomised , double-blind controlled study .
METHODS	A total of 75 patients who were scheduled to undergo supraclavicular block were randomly assigned into three groups ( i.e. clonidine , lignocaine and control groups ) of 25 .
METHODS	Patients in all three groups received 20 mL of 0.75 % ropivacaine .
METHODS	In addition to that , patients in the clonidine group received 1 mL of clonidine ( 150 g ) plus 9 mL of saline , patients in the lignocaine group received 10 mL of 2 % lignocaine with adrenaline ( 1:200,000 ) , and patients in the control group received 10 mL of saline .
METHODS	The characteristics of anaesthesia and analgesia for these three groups were assessed .
RESULTS	The addition of 2 % lignocaine with adrenaline to ropivacaine led to earlier onset of the sensory block ( by 4.88 mins ) , but no increase in the duration of analgesia when compared to analgesia using ropivacaine alone .
RESULTS	The addition of clonidine to ropivacaine led to earlier onset of sensory and motor blocks ( by 2.88 mins and 3.28 mins , respectively ) , as well as an increased duration of sensory and motor blocks ( by 222.64 mins and 192.92 mins , respectively ) when compared to analgesia using ropivacaine alone .
RESULTS	The total duration of analgesia was increased by 208.24 mins with clonidine when compared to analgesia using ropivacaine alone .
RESULTS	There were no significant differences in sedation score and no side effects in all three groups .
CONCLUSIONS	When compared to the use of ropivacaine alone , the addition of 150 g clonidine to ropivacaine for brachial plexus block achieved earlier analgesic onset and improved duration of analgesia , without unwanted side effects .

###24273976
OBJECTIVE	To explore the effect and the mechanism of Danhong Injection ( DI ) , Ligustrazine Injection ( LI ) , and adsorbable biomembranes in preventing the adhesion of tendons and tissues .
METHODS	Totally 120 patients all suffering from simple flexor digitorum tendon rupture on the hand zone two damaged by sharp weapons were randomly assigned to Group A ( Dikang adsorbable biomembrane ) , Group B ( Tianxinfu adsorbable biomembrane ) , Group C ( Tianxinfu adsorbable biomembrane + Ligustrazine group ) , and Group D ( Tianxinfu adsorbable biomembrane + DI group ) in accordance with random digit table , 30 cases in each group .
METHODS	Indicators such as total active movement ( TAM ) of the hand tendon , Minnesota manual dexterity test ( MMDT ) , and finger flex strength test ( FFST ) were observed .
RESULTS	The TAM and the favorable rate were higher in Group C and D than in Group A and B at post-operative 4 and 8 week ( P < 0.05 , P < 0.01 ) .
RESULTS	There was no statistical difference between Group C and D ( P > 0.05 ) .
RESULTS	Each index of MMDT was lower in Group C and D than in Group A and B ( P < 0.05 ) .
RESULTS	There was no statistical difference in FFST among all the 4 groups ( P > 0.05 ) .
CONCLUSIONS	Combined application of LI or DI with Tianxinfu adsorbable biomembranes could effectively prevent the adhesion of tendons .
CONCLUSIONS	DI showed equivalent effect as LI did .
CONCLUSIONS	Besides , the combined application was superior in preventing adhesion to using Xintianfu adsorbable biomembrane or Dikan adsorbable biomembrane alone .

###25578128
CONCLUSIONS	Sham acupuncture turned out to be more effective than expected .
CONCLUSIONS	The effect of acupuncture can not be assessed by optical rhinometry ( ORM ) .
OBJECTIVE	In most cases nasal congestion is caused by hypertrophy of the inferior turbinate as a result of allergic and chronic rhinitis .
OBJECTIVE	Topical decongestants cause severe side effects .
OBJECTIVE	As a consequence , there is an increasing demand for alternative treatment options such as traditional Chinese medicine ( TCM ) .
METHODS	A total of 25 patients with nasal congestion due to hypertrophic inferior turbinate were recruited .
METHODS	The mucosal swelling status of the inferior turbinate was assessed by continuous ORM for 20 min .
METHODS	Patients were asked to score the severity of their nasal congestion on a visual analogue scale ( VAS ) before and 10 and 20 min after acupuncture .
METHODS	Specific verum acupuncture points related to nasal congestion were tested against non-specific control sham acupuncture points .
RESULTS	Sham acupuncture improved VAS scores , whereas ORM measured an increase in nasal swelling .
RESULTS	The ORM revealed a quicker onset of the effect of verum acupuncture on the nasal blood flow .
RESULTS	Also , verum acupuncture reaches its maximum effect in a shorter time period , so that the net reaction time was much shorter .
RESULTS	However , ORM could not prove a decongestant effect of verum acupuncture on inferior turbinate .

###25010538
OBJECTIVE	To compare the efficacy of gait training using a single-leg version of the Hybrid Assistive Limb ( HAL ) on the paretic side with conventional gait training in individuals with subacute stroke .
METHODS	Randomized open controlled pilot trial .
METHODS	Hospitalized care .
METHODS	Convenience sample of 44 patients who met the criteria ; 12 patients refused .
METHODS	After randomization ( N = 32 ) , 10 patients withdrew and a total of 22 poststroke participants ( HAL group : n = 11 ; conventional group : n = 11 ) completed the randomized controlled trial .
METHODS	All participants received twelve 20-minute sessions in 4 weeks of either HAL ( wearing the single-leg version of the HAL on their paretic side ) or conventional ( performed by skilled and experienced physical therapists ) gait training .
METHODS	Outcome measures were evaluated prior to training and after 12 sessions .
METHODS	Functional Ambulation Category ( FAC ) was the primary outcome measure , whereas secondary outcome measures included maximum walking speed , timed Up and Go test , 6-minute walk distance , Short Physical Performance Battery , Fugl-Meyer Assessment of Lower Extremity , and isometric muscle strength ( hip flexion and extension , knee flexion and extension ) .
RESULTS	No participants withdrew because of adverse effects .
RESULTS	Participants who received gait training with the HAL showed significantly more improvement in the FAC than those who received conventional gait training ( 95 % confidence interval , .02 -.88 ; P = .04 ) .
RESULTS	Secondary measures did not differ between the 2 groups .
CONCLUSIONS	The results obtained in this randomized controlled trial suggest that a gait training program with the HAL could improve independent walking more efficiently than conventional gait training .

###24964689
OBJECTIVE	To investigate the effectiveness of a program that utilizes community involvement to improve the self-management strategies among people living with hypertension .
METHODS	Forty-four subjects , aged 35 to 59-year-old , with hypertension in Nakhon Pathom Province , Thailand , were randomly allocated to either an experimental group ( n = 22 ) or a control group ( n = 20 ) .
METHODS	The experimental group attended a program to improve self-management methods based on social cognitive theory ( SCT ) .
METHODS	The program lasted 12 weeks , consisted of 1 1/2 hours meeting once a week , including group meetings and home visit monitoring .
METHODS	Mann-Whitney U test and Friedman test were employed to analyze the program 's effectiveness .
RESULTS	After the program , the mean rank of the perceived self-efficacy for the self-management strategies was statistically different between the two groups ( p = 0.023 ) .
RESULTS	In the experimental group , after the twelve week , the mean rank of perceived self-efficacy and outcome expectancy increased and diastolic blood pressure decreased after the eight week .
CONCLUSIONS	The program applied social cognitive theory ( SCT ) to promote self-management techniques , increased the health promoting behavior among hypertensive people .

###24521874
BACKGROUND	The antiepileptic drug topiramate reduces levodopa-induced dyskinesia without exacerbating parkinsonism in animal models .
BACKGROUND	We report a randomized , double-blind , placebo-controlled crossover trial in patients with Parkinson 's disease and levodopa-induced dyskinesia .
METHODS	Fifteen patients with Parkinson 's disease and stable levodopa-induced dyskinesia were enrolled into the study , of whom 13 were randomized to topiramate or placebo .
METHODS	The study medication was titrated to 100mg/day over four weeks , and assessments were carried out after a further two weeks .
METHODS	Dyskinesia severity assessed by a blinded rater from video recordings was the primary outcome measure .
RESULTS	Seven patients ( mean age 58.912.8 years ) completed the study .
RESULTS	Patients taking topiramate vs. placebo showed a significant increase in dyskinesia severity compared to baseline ( Wilcoxon signed rank test , P = 0.043 ) .
RESULTS	Five patients withdrew from the study whilst taking topiramate due to adverse effects .
CONCLUSIONS	Topiramate tended to worsen dyskinesia in patients with Parkinson 's disease , and was poorly tolerated .

###24287217
OBJECTIVE	Does functional electrical stimulation ( FES ) cycling increase urine output and decrease lower limb swelling and spasticity in people with recent spinal cord injury ?
METHODS	Randomised cross-over trial .
METHODS	Fourteen participants with a recent motor complete spinal cord injury were consecutively recruited from two spinal cord injury units in Sydney .
METHODS	Participants were randomised to an experimental phase followed by a control phase or vice versa , with a 1-week washout period in between .
METHODS	The experimental phase involved FES cycling four times a week for two weeks and the control phase involved standard rehabilitation for two weeks .
METHODS	Assessments by a blinded assessor occurred at the beginning and end of each phase .
METHODS	Allocation was concealed and an intention-to-treat analysis was performed .
METHODS	The primary outcome was urine output ( mL/hr ) and the secondary outcomes were lower limb circumference , and spasticity using the Ashworth Scale , and the Patient Reported Impact of Spasticity Measure ( PRISM ) .
METHODS	In addition , participants were asked open-ended questions to explore their perceptions about treatment effectiveness .
RESULTS	All participants completed the study .
RESULTS	The mean between-group difference ( 95 % CI ) for urine output was 82mL/hr ( -35 to 199 ) .
RESULTS	The mean between-group differences ( 95 % CI ) for lower limb swelling , spasticity ( Ashworth ) , and PRISM were -0.1 cm ( -1.5 to 1.2 ) , -1.9 points ( -4.9 to 1.2 ) and -5 points ( -13 to 2 ) , respectively .
RESULTS	All point estimates of treatment effects favoured FES cycling .
RESULTS	Participants reported many benefits from FES cycling .
CONCLUSIONS	There were no clear effects of FES cycling on urine output , swelling and spasticity even though all point estimates of treatment effects favoured FES cycling and participants perceived therapeutic effects .
BACKGROUND	ACTRN12611000923965 .

###24849105
OBJECTIVE	Coronary artery bypass grafting ( CABG ) has been considered the standard of care for patients with three-vessel disease ( 3VD ) , but long-term comparative results from randomized trials of CABG vs. percutaneous coronary intervention ( PCI ) using drug-eluting stents ( DES ) remain limited .
RESULTS	Patients with de novo 3VD or left main disease were randomly assigned to PCI with the paclitaxel-eluting first-generation stent or CABG in the SYNTAX trial .
RESULTS	This pre-specified analysis presents the 5-year outcomes of patients with 3VD ( n = 1095 ) .
RESULTS	The rate of major adverse cardiac and cerebrovascular events ( MACCE ) was significantly higher in patients with PCI compared with CABG ( 37.5 vs. 24.2 % , respectively ; P < 0.001 ) .
RESULTS	Percutaneous coronary intervention as opposed to CABG resulted in significantly higher rates of the composite of death/stroke/myocardial infarction ( MI ) ( 22.0 vs. 14.0 % , respectively ; P < 0.001 ) , all-cause death ( 14.6 vs. 9.2 % , respectively ; P = 0.006 ) , MI ( 9.2 vs. 4.0 % , respectively ; P = 0.001 ) , and repeat revascularization ( 25.4 vs. 12.6 % , respectively ; P < 0.001 ) ; however , stroke was similar between groups at 5 years ( 3.0 vs. 3.5 % , respectively ; P = 0.66 ) .
RESULTS	Results were dependent on lesion complexity ( P for interaction = 0.12 ) ; in patients with a low ( 0-22 ) SYNTAX score , PCI vs. CABG resulted in similar rates of MACCE ( 33.3 % vs. 26.8 % , respectively ; P = 0.21 ) but significantly more repeat revascularization ( 25.4 % vs. 12.6 % , respectively ; P = 0.038 ) , while in intermediate ( 23-32 ) or high ( 33 ) SYNTAX score terciles , CABG demonstrated clear superiority in terms of MACCE , death , MI , and repeat revascularization .
RESULTS	Differences in MACCE between PCI and CABG were larger in diabetics [ hazard ratio ( HR ) = 2.30 ] than non-diabetics ( HR = 1.51 ) , although the P for interaction failed to reach significance for MACCE ( P for interaction = 0.095 ) or any of the other endpoints .
CONCLUSIONS	Five-year results of patients with 3VD treated with CABG or PCI using the first-generation paclitaxel-eluting DES suggest that CABG should remain the standard of care as it resulted in significantly lower rates of death , MI , and repeat revascularization , while stroke rates were similar .
CONCLUSIONS	For patients with low SYNTAX scores , PCI is an acceptable revascularization strategy , although at a price of significantly higher rates of repeat revascularization .
BACKGROUND	NCT00114972 .

###25496674
OBJECTIVE	This study aimed to compare the effects of topical and systemic lignocaine on the circulatory response to direct laryngoscopy performed under general anaesthesia .
METHODS	Ninety-nine patients over 20 years of age , with a physical status of I-II ( classified according to the American Society of Anesthesiologists ) , were randomly allocated to 3 groups .
METHODS	One group received 5ml of 0.9 per cent physiological saline intravenously , one group received 1.5 mg/kg lignocaine intravenously , and another group received seven puffs of 10 per cent lignocaine aerosol applied topically to the airway .
METHODS	Mean arterial pressures , heart rates and peripheral oxygen saturations were recorded , and changes in mean arterial pressure and heart rate ratios were calculated .
RESULTS	Changes in the ratios of mean arterial pressure and heart rate were greater in the saline physiological group than the other groups at 1 minute after intubation .
RESULTS	Changes in the ratios of mean arterial pressure ( at the same time point ) were greater in the topical lignocaine group than in the intravenous lignocaine group , but this finding was not statistically significant .
CONCLUSIONS	Lignocaine limited the haemodynamic responses to laryngoscopy and endotracheal intubation during general anaesthesia in rigid suspension laryngoscopy .

###25354015
OBJECTIVE	To investigate whether planning target volume ( PTV ) margins may be safely reduced in radiotherapy of localized prostate cancer incorporating daily online tube potential-cone beam CT ( CBCT ) image guidance and the anticipated benefit in predicted rectal toxicity .
METHODS	The prostate-only clinical target volume ( CTV2 ) and rectum were delineated on 1 pre-treatment CBCT each week in 18 randomly selected patients .
METHODS	By transposing these contours onto the original plan , dose-volume histograms ( DVHs ) for CTV2 and the rectum were each calculated and combined , for each patient , to produce a single mean DVH representative of the dose delivered over the treatment course .
METHODS	Plans were reoptimized using reduced CTV2 to PTV2 margins and the consequent radiobiological impact modelled by the tumour control probability ( TCP ) and normal tissue complication probability ( NTCP ) of the rectum .
RESULTS	All CBCT images were deemed of sufficient quality to identify the CTV and rectum .
RESULTS	No loss of TCP was observed when plans using the standard 5-mm CTV2 to PTV2 margin of the centre were reoptimized with a 4 - or 3-mm margin .
RESULTS	Margin reduction was associated with a significant decrease in rectal NTCP ( 5-4mm ; p < 0.05 and 5-3mm ; p < 0.01 ) .
CONCLUSIONS	Using daily online image guidance with CBCT , a reduction in CTV2 to PTV2 margins to 3mm is achievable without compromising tumour control .
CONCLUSIONS	The consequent sparing of surrounding normal tissues is associated with reduced anticipated rectal toxicity .
CONCLUSIONS	Margin reduction is feasible and potentially beneficial .
CONCLUSIONS	Centres with image-guided radiotherapy capability should consider assessing whether margin reduction is possible within their institutes .

###24958820
OBJECTIVE	Risk of cancer progression is reduced for patients with human papillomavirus ( HPV ) - positive oropharynx cancer ( OPC ) relative to HPV-negative OPC , but it is unknown whether risk of death after progression is similarly reduced .
METHODS	Patients with stage III-IV OPC enrolled onto Radiation Therapy Oncology Group trials 0129 or RTOG 0522 who had known tumor p16 status plus local , regional , and/or distant progression after receiving platinum-based chemoradiotherapy were eligible for a retrospective analysis of the association between tumor p16 status and overall survival ( OS ) after disease progression .
METHODS	Rates were estimated by Kaplan-Meier method and compared by log-rank ; hazard ratios ( HRs ) were estimated by Cox models .
METHODS	Tests and models were stratified by treatment protocol .
RESULTS	A total of 181 patients with p16-positive ( n = 105 ) or p16-negative ( n = 76 ) OPC were included in the analysis .
RESULTS	Patterns of failure and median time to progression ( 8.2 v 7.3 months ; P = .67 ) were similar for patients with p16-positive and p16-negative tumors .
RESULTS	After a median follow-up period of 4.0 years after disease progression , patients with p16-positive OPC had significantly improved survival rates compared with p16-negative patients ( 2-year OS , 54.6 % v 27.6 % ; median , 2.6 v 0.8 years ; P < .001 ) .
RESULTS	p16-positive tumor status ( HR , 0.48 ; 95 % CI , 0.31 to 0.74 ) and receipt of salvage surgery ( HR , 0.48 ; 95 % CI ; 0.27 to 0.84 ) reduced risk of death after disease progression whereas distant versus locoregional progression ( HR , 1.99 ; 95 % CI , 1.28 to 3.09 ) increased risk , after adjustment for tumor stage and cigarette pack-years at enrollment .
CONCLUSIONS	Tumor HPV status is a strong and independent predictor of OS after disease progression and should be a stratification factor for clinical trials for patients with recurrent or metastatic OPC .

###24637537
BACKGROUND	We analyzed the potential of abiraterone acetate ( henceforth abiraterone ) to reduce androgen levels below lower limits of quantification ( LLOQ ) and explored the association with changes in PSA decline in metastatic castration-resistant prostate cancer ( mCRPC ) patients .
METHODS	COU-AA-301 is a 2:1 randomized , double-blind , placebo-controlled study comparing abiraterone ( 1000mg q.d. ) plus low-dose prednisone ( 5mg b.i.d. ) with placebo plus prednisone in mCRPC patients post docetaxel .
METHODS	Serum testosterone , androstenedione and dehydroepiandrosterone sulfate from baseline to week 12 were measured by novel ultrasensitive two-dimensional liquid chromatography coupled to tandem mass spectrometry assays in a subset of subjects in each arm ( abiraterone plus prednisone , n = 80 ; prednisone , n = 38 ) .
METHODS	The association between PSA response ( < or = 50 % baseline ) and undetectable androgens ( week 12 androgen level below LLOQ ) was analyzed using logistic regression .
RESULTS	A significantly greater reduction in serum androgens was observed with abiraterone plus prednisone versus prednisone ( all P < or = 0.0003 ) , reaching undetectable levels for testosterone ( 47.2 % versus 0 % , respectively ) .
RESULTS	A positive association was observed between achieving undetectable serum androgens and PSA decline ( testosterone : odds ratio = 1.54 ; 95 % confidence interval : 0.546-4 .347 ) .
RESULTS	Reduction of androgens to undetectable levels did not occur in all patients achieving a PSA response , and a PSA response did not occur in all patients achieving undetectable androgen levels .
CONCLUSIONS	Abiraterone plus prednisone significantly reduced serum androgens , as measured by ultrasensitive assays and was generally associated with PSA response .
CONCLUSIONS	However , androgen decline did not uniformly predict PSA decline suggesting ligand-independent or other mechanisms for mCRPC progression .

###25074734
OBJECTIVE	Maintaining quality of life ( QOL ) and physical and mental health status are important outcomes throughout the aging process .
OBJECTIVE	Although cross-sectional studies suggest a relationship between global QOL and physical activity , it is unclear whether such a relationship exists as a function of exercise training .
METHODS	We examined the effects of two exercise intervention arms on health-related quality of life ( HRQOL ) and global QOL .
METHODS	Low-active , older adults ( n = 179 ) were randomly assigned to either a 12-month aerobic walking group or a strengthening and flexibility group .
METHODS	HRQOL and QOL were measured at baseline , 6 , and 12 months .
RESULTS	There was a significant group by time effect on QOL [ F ( 2,176 ) = 3.11 , p = 0.047 , ( 2 ) = 0.03 ] .
RESULTS	There was also a significant overall group by time effect for HRQOL [ F ( 4,174 ) = 2.46 , p = 0.047 , ( 2 ) = 0.05 ] , which was explained by the significant group by time interaction for mental health status ( p = 0.041 , ( 2 ) = 0.02 ) favoring the walking condition .
RESULTS	Further analyses using latent class analysis revealed three classes of individuals with differential patterns of change in QOL and HRQOL across time .
RESULTS	These classes reflected no change , declines , and improvements in these constructs across time .
CONCLUSIONS	Walking appears to enhance the mental aspect of HRQOL and global QOL when compared to a non-aerobic intervention .
CONCLUSIONS	Additionally , the patterns of change in QOL and HRQOL were not linear over time .
CONCLUSIONS	Our findings are in contrast to previous reports that these outcomes change a little or not at all in randomized trials .

###24846707
OBJECTIVE	This study explores the usefulness of virtual simulation training for learning to place pedicle screws in the lumbar spine .
METHODS	Twenty-six senior medical students anonymously participated and were randomized into two groups ( A = no simulation ; B = simulation ) .
METHODS	Both groups were given 15 minutes to place two pedicle screws in a sawbones model .
METHODS	Students in Group A underwent traditional visual/verbal instruction whereas students in Group B underwent training on pedicle screw placement in the ImmersiveTouch simulator .
METHODS	The students in both groups then placed two pedicle screws each in a lumbar sawbones models that underwent triplanar thin slice computerized tomography and subsequent analysis based on coronal entry point , axial and sagittal deviations , length error , and pedicle breach .
METHODS	The average number of errors per screw was calculated for each group .
METHODS	Semi-parametric regression analysis for clustered data was used with generalized estimating equations accommodating a negative binomial distribution to determine any statistical difference of significance .
RESULTS	A total of 52 pedicle screws were analyzed .
RESULTS	The reduction in the average number of errors per screw after a single session of simulation training was 53.7 % ( P = 0.0067 ) .
RESULTS	The average number of errors per screw in the simulation group was 0.96 versus 2.08 in the non-simulation group .
RESULTS	The simulation group outperformed the non-simulation group in all variables measured .
RESULTS	The three most benefited measured variables were length error ( 86.7 % ) , coronal error ( 71.4 % ) , and pedicle breach ( 66.7 % ) .
CONCLUSIONS	Computer-based simulation appears to be a valuable teaching tool for non-experts in a highly technical procedural task such as pedicle screw placement that involves sequential learning , depth perception , and understanding triplanar anatomy .

###26056183
OBJECTIVE	We compared nab-paclitaxel or ixabepilone once per week to paclitaxel with bevacizumab as first-line therapy for patients with advanced breast cancer ( BC ) to evaluate progression-free survival ( PFS ) for nab-paclitaxel or ixabepilone versus paclitaxel .
METHODS	Eligible patients were age 18 years with chemotherapy-naive advanced BC .
METHODS	Patients were randomly assigned to bevacizumab with paclitaxel 90 mg/m ( 2 ) ( arm A ) , nab-paclitaxel 150 mg/m ( 2 ) ( arm B ) , or ixabepilone 16 mg/m ( 2 ) ( arm C ) , once per week for 3 of 4 weeks .
METHODS	Planned enrollment was 900 patients , which would give 88 % power to detect a hazard ratio of 0.73 .
RESULTS	In all , 799 patients were enrolled , and 783 received treatment ( 97 % received bevacizumab ) .
RESULTS	Arm C was closed for futility at the first interim analysis ( n = 241 ) , and arm A ( n = 267 ) and arm B ( n = 275 ) were closed for futility at the second interim analysis .
RESULTS	Median PFS for paclitaxel was 11 months , ixabepilone was inferior to paclitaxel ( PFS , 7.4 months ; hazard ratio , 1.59 ; 95 % CI , 1.31 to 1.93 ; P < .001 ) , and nab-paclitaxel was not superior to paclitaxel ( PFS , 9.3 months ; hazard ratio , 1.20 ; 95 % CI , 1.00 to 1.45 ; P = .054 ) .
RESULTS	Results were concordant with overall survival ; time to treatment failure was significantly shorter in both experimental arms v paclitaxel .
RESULTS	Hematologic and nonhematologic toxicity , including peripheral neuropathy , was increased with nab-paclitaxel , with more frequent and earlier dose reductions .
CONCLUSIONS	In patients with chemotherapy-naive advanced BC , ixabepilone once per week was inferior to paclitaxel , and nab-paclitaxel was not superior with a trend toward inferiority .
CONCLUSIONS	Toxicity was increased in the experimental arms , particularly for nab-paclitaxel .
CONCLUSIONS	Paclitaxel once per week remains the preferred palliative chemotherapy in this setting .

###24823599
OBJECTIVE	The aim of the present study was to assess the efficacy and safety of vildagliptin as add-on to sulfonylurea therapy in Chinese patients with type 2 diabetes mellitus ( T2DM ) inadequately controlled on sulfonylurea monotherapy .
METHODS	The 24-week randomized double-blind placebo-controlled study compared vildagliptin 50mg , q.d. , with placebo as add-on to glimepiride in T2DM patients who were inadequately controlled ( HbA1c 7.5 % -11.0 % [ 58-97mmol / mol ] ) on a stable dose of sulfonylurea for 12 weeks before study entry .
RESULTS	In all , 279 patients were randomized to receive either vildagliptin ( n = 143 ) or placebo ( n = 136 ) .
RESULTS	At baseline , overall mean age was 58.5 years , body weight 68.1 kg , duration of diabetes 6.9 years and daily glimepiride dose 3.3 mg .
RESULTS	After 24 weeks , the adjusted mean change ( AM ) in HbA1c was -0.7 % ( -8 mmol/mol ; baseline 8.6 % , 70mmol/mol ) in the vildagliptin group and -0.2 % ( -2 mmol/mol ; baseline 8.7 % , 72mmol/mol ) in the placebo group , with a treatment difference of -0.5 % ( -5 mmol/mol ; P < 0.001 ) .
RESULTS	The between-group difference in AM in fasting plasma glucose was -0.4 mmol/L ( P = 0.160 ) .
RESULTS	There was a slight , but not significant , decrease in body weight in both groups .
RESULTS	No hypoglycemic events were reported in either group , including those patients reaching HbA1c < 7.0 % .
RESULTS	Patients in the vildagliptin and placebo groups reported low and comparable incidences of adverse events ( 14.0 % vs. 17.8 % ) and serious adverse events ( 0.7 % in each group ) .
CONCLUSIONS	Vildagliptin 50mg , q.d. , added to sulfonylurea monotherapy is effective in Chinese patients with T2DM , without increasing the risk of hypoglycemia and weight gain .

###25563737
OBJECTIVE	A distinct suppressive effect of a whey protein ( including glycomacropeptide ) - enriched preload drink on subsequent food intake in comparison with a maltodextrin carbohydrate-enriched preload was demonstrated in an earlier companion study with the same female subjects ; however , the potential mediators underlying the effect are unclear .
OBJECTIVE	The objective of this study was to investigate how the ingestion of a whey protein-enriched preload beverage affected postprandial plasma concentrations of several satiety-related gastrointestinal hormones and metabolites in comparison with a maltodextrin carbohydrate-enriched preload .
METHODS	Eighteen normal-weight women were studied in a single-blind , randomized block design .
METHODS	Blood samples were collected at various time intervals for 120min after consumption of a test drink ( 300ml , ~ 1300kJ ) enriched ( 45g ) with either maltodextrin carbohydrate or whey protein containing naturally present glycomacropeptide .
RESULTS	Plasma-active ghrelin concentrations decreased after both maltodextrin carbohydrate - and whey protein-enriched test drinks ( P < 0.05 ) .
RESULTS	The whey protein-enriched beverage led to increased plasma concentrations of cholecystokinin ( CCK ) at 60 and 75min ( P < 0.05 ) , glucagon-like peptide-1 ( GLP-1 ) at 90min ( P < 0.001 ) , peptide tyrosine-tyrosine ( PYY ) at 90 and 120min ( P < 0.01 ) and pancreatic polypeptide ( PP ) from 15 to 120min ( P < 0.05 ) compared with maltodextrin carbohydrate .
RESULTS	Total amino acid , urea and ammonia plasma concentrations were also higher after whey protein compared with maltodextrin carbohydrate ingestion ( P < 0.01 ) .
CONCLUSIONS	Increased plasma concentrations of some gastrointestinal hormones related to satiety , particularly PP , and of amino acids and their metabolites , may have acted either singly or together to mediate the observed satiety response to whey protein .

###24382614
BACKGROUND	Sleep deprivation in hospitalized patients is common and can have serious detrimental effects on recovery from illness .
BACKGROUND	Lavender aromatherapy has improved sleep in a variety of clinical settings , but the effect has not been tested in the intermediate care unit .
OBJECTIVE	To determine the effect of inhalation of 100 % lavender oil on patients ' vital signs and perceived quality of sleep in an intermediate care unit .
METHODS	A randomized controlled pilot study was conducted in 50 patients .
METHODS	Control patients received usual care .
METHODS	The treatment group had 3 mL of 100 % pure lavender oil in a glass jar in place at the bedside from 10 pm until 6 am .
METHODS	Vital signs were recorded at intervals throughout the night .
METHODS	At 6 am all patients completed the Richard Campbell Sleep Questionnaire to assess quality of sleep .
RESULTS	Blood pressure was significantly lower between midnight and 4 am in the treatment group than in the control group ( P = .03 ) According to the overall mean change score in blood pressure between the baseline and 6 am measurements , the treatment group had a decrease in blood pressure and the control group had an increase ; however , the difference between the 2 groups was not significant ( P = .12 ) .
RESULTS	Mean overall sleep score was higher in the intervention group ( 48.25 ) than in the control group ( 40.10 ) , but the difference was not significant .
CONCLUSIONS	Lavender aromatherapy may be an effective way to improve sleep in an intermediate care unit .

###25853746
BACKGROUND	Some observational studies have reported that transfusion of red-cell units that have been stored for more than 2 to 3 weeks is associated with serious , even fatal , adverse events .
BACKGROUND	Patients undergoing cardiac surgery may be especially vulnerable to the adverse effects of transfusion .
METHODS	We conducted a randomized trial at multiple sites from 2010 to 2014 .
METHODS	Participants 12 years of age or older who were undergoing complex cardiac surgery and were likely to undergo transfusion of red cells were randomly assigned to receive leukocyte-reduced red cells stored for 10 days or less ( shorter-term storage group ) or for 21 days or more ( longer-term storage group ) for all intraoperative and postoperative transfusions .
METHODS	The primary outcome was the change in Multiple Organ Dysfunction Score ( MODS ; range , 0 to 24 , with higher scores indicating more severe organ dysfunction ) from the preoperative score to the highest composite score through day 7 or the time of death or discharge .
RESULTS	The median storage time of red-cell units provided to the 1098 participants who received red-cell transfusion was 7 days in the shorter-term storage group and 28 days in the longer-term storage group .
RESULTS	The mean change in MODS was an increase of 8.5 and 8.7 points , respectively ( 95 % confidence interval for the difference , -0.6 to 0.3 ; P = 0.44 ) .
RESULTS	The 7-day mortality was 2.8 % in the shorter-term storage group and 2.0 % in the longer-term storage group ( P = 0.43 ) ; 28-day mortality was 4.4 % and 5.3 % , respectively ( P = 0.57 ) .
RESULTS	Adverse events did not differ significantly between groups except that hyperbilirubinemia was more common in the longer-term storage group .
CONCLUSIONS	The duration of red-cell storage was not associated with significant differences in the change in MODS .
CONCLUSIONS	We did not find that the transfusion of red cells stored for 10 days or less was superior to the transfusion of red cells stored for 21 days or more among patients 12 years of age or older who were undergoing complex cardiac surgery .
CONCLUSIONS	( Funded by the National Heart , Lung , and Blood Institute ; RECESS ClinicalTrials.gov number , NCT00991341 . )

###24721888
OBJECTIVE	The two largest studies of mammalian target of rapamycin inhibitor treatment of autosomal dominant polycystic kidney disease ( ADPKD ) demonstrated no clear benefit on the primary endpoint of total kidney volume ( TKV ) or on eGFR .
OBJECTIVE	The present study evaluated two levels of rapamycin on the 12-month change in ( 125 ) I-iothalamate GFR ( iGFR ) as the primary endpoint and TKV secondarily .
METHODS	In a 12-month open-label pilot study , 30 adult patients with ADPKD were randomly assigned to low-dose ( LD ) rapamycin ( rapamycin trough blood level , 2-5 ng/ml ) ( LD group , n = 10 ) , standard-dose ( STD ) rapamycin trough level ( > 5-8 ng/ml ) ( STD group , n = 10 ) , or standard care ( SC group , n = 10 ) .
METHODS	They were evaluated with iGFR and noncontrast computed tomography .
RESULTS	Change in iGFR at 12 months was significantly higher in the LD group ( 7.712.5 ml/min per 1.73 m ( 2 ) ; n = 9 ) than in the SC group ( -11.2 9.1 ml/min per 1.73 m ( 2 ) ; n = 9 ) ( LD versus SC : P < 0.01 ) .
RESULTS	Change in iGFR at 12 months in the STD group ( 1.6 12.1 ml/min per 1.73 m ( 2 ) ; n = 8 ) was not significantly greater than that in the SC group ( P = 0.07 ) , but it was in the combined treatment groups ( LD+STD versus SC : P < 0.01 ) .
RESULTS	Neither eGFR calculated by the CKD-Epidemiology Collaboration equation nor TKV ( secondary endpoint ) changed significantly from baseline to 12 months in any of the groups .
RESULTS	On the basis of results of the mixed model , during the study , patients in the LD group had significantly lower trough blood levels of rapamycin ( mean range SD , 2.40 0.64 to 2.90 1.20 ng/ml ) compared with those in the STD group ( 3.93 2.27 to 5.77 1.06 ng/ml ) ( P < 0.01 ) .
CONCLUSIONS	Patients with ADPKD receiving LD rapamycin demonstrated a significant increase in iGFR compared with those receiving standard care , without a significant effect on TKV after 12 months .

###25428566
BACKGROUND	Conclusive evidence indicating an effective treatment for carpal tunnel syndrome ( CTS ) , a common entrapment neuropathy , is lacking .
BACKGROUND	Ultrasound therapy ( US therapy ) has long been used as one of the combination treatments for CTS .
BACKGROUND	In addition , paraffin bath therapy has been applied widely as a physical modality in treating patients with hand conditions .
BACKGROUND	The purpose of this randomized trial was to compare the efficacy of combining a wrist orthosis with either US therapy or paraffin bath therapy in treating CTS patients .
METHODS	Patients with CTS were randomized into two groups .
METHODS	All patients received a wrist orthosis .
METHODS	Twice per week , one group underwent paraffin therapy , and the other group underwent ultrasound therapy .
METHODS	Each patient received a questionnaire , physical examination and nerve conduction study of the upper extremities before and after treatment for eight weeks .
RESULTS	Sixty patients were recruited , and 47 completed the study .
RESULTS	Statistical analysis revealed significant improvements in symptom severity scores in both groups .
RESULTS	After adjusting for age , gender and baseline data , the analysis of covariance revealed a significant difference in the functional status score between two groups .
CONCLUSIONS	The combination of ultrasound therapy with a wrist orthosis may be more effective than paraffin therapy with a wrist orthosis .
BACKGROUND	Clinicaltrial.gov : NCT02278289 Oct 28 , 2014 .

###24463121
OBJECTIVE	To study the role of exercise in asthma management in children and formulate exercise prescriptions for asthmatic children .
METHODS	A total of 112 asthmatic children aged 7-14 years were randomized into control group ( n = 56 , with medications only ) and exercise group ( n = 56 , with medications and exercise prescription ) for a trial lasting for 4 months .
METHODS	An asthma diary was used for all children to record the morning and evening peak expiratory flow ( PEF ) , daytime and nighttime asthma symptom score , use of short-acting beta agonists , participation in physical activity , and exercise-induced asthma symptoms .
RESULTS	Of the 112 children , 5 dropped out before the trial completion .
RESULTS	From the 13th week , PEF variation in exercise group was significantly lowered compared to that in the control group ( P < 0.05 ) .
RESULTS	Upon the completion of the trial , the daytime and nighttime symptoms score and emergency medication score were all significantly lower in the exercise group than in the control group ( P < 0.05 ) .
RESULTS	No severe adverse events occurred in the children during the trial .
CONCLUSIONS	Exercise for no less than 20 min , 3 days a week for 4 months is safe and beneficial for asthma control in children .

###26094093
BACKGROUND	Karydakis flap ( K-flap ) and excision with healing by secondary intention ( EHSI ) are currently accepted methods for surgical management of sacrococcygeal pilonidal disease .
BACKGROUND	This clinical trial study aimed to compare early and late outcomes of these two surgical techniques .
METHODS	In this controlled , prospective , randomized clinical trial , patients diagnosed with sacrococcygeal pilonidal disease were randomly allocated to two groups .
METHODS	Patients in the first group underwent Karydakis procedure , whereas EHSI was the surgical management in the second group .
METHODS	The two techniques were compared based on their overall time of wound healing , return to work , rate of complications , and recurrence .
RESULTS	A total of 321 patients including 161 in the K-flap group and 160 in the EHSI group were included in the study .
RESULTS	The median follow-up duration was 49 mo. .
RESULTS	The mean time of wound healing ( 16.44 versus 80.01 d , P < 0.001 ) , return to work ( 14.44 versus 24.19 , P < 0.001 ) , rate of wound complications ( 18.7 % versus 31.2 % , P = 0.006 ) , and recurrence ( 1.2 % versus 7.5 % , P = 0.005 ) were all significantly lower in the K-flap group .
RESULTS	The mean operation time was significantly shorter in the EHSI group ( 15.87 versus 55.17 min , P < 0.001 ) .
RESULTS	The K-flap group showed significantly higher pain on their first postoperative day and significantly less pain after 1 wk ( P < 0.001 ) .
CONCLUSIONS	Although both techniques are safe , the K-flap is associated with significantly lower rates of complications and recurrence and significantly shorter time of wound healing and return to work .

###25464226
OBJECTIVE	The adverse prognostic impact of metabolic syndrome ( METS ) in unselected populations and in patients with coronary heart disease has been previously shown .
OBJECTIVE	The aim of the current analysis was to evaluate the impact of METS on prognosis in chronic heart failure ( HF ) .
METHODS	International Diabetes Federation criteria were used for the diagnosis of METS .
METHODS	Adjusted Cox regression models with all-cause and HF death as outcomes were fitted in 6648 patients enrolled in GISSI-HF trial with no missing values for the variables of interest .
RESULTS	Risk of all-cause and HF death was significantly reduced in patients with METS compared to patients without METS ( HR : 0.83 , 95 % CI : 0.72 to 0.95 , p = 0.005 ; HR : 0.76 , 95 % CI : 0.59 to 0.98 , p = 0.031 ; respectively ) .
RESULTS	As compared with patients with no METS and no type 2 diabetes mellitus ( DM ) , the risk of all-cause and HF death was significantly lower in patients with METS and no DM ( HR : 0.76 , 95 % CI : 0.62 to 0.95 , p = 0.015 ; HR : 0.65 , 95 % CI : 0.42 to 0.99 , p = 0.046 ; respectively ) , whereas it was significantly increased in patients with DM and no METS ( HR : 1.34 , 95 % CI : 1.21 to 1.48 , p < 0.001 ; HR : 1.44 , 95 % CI : 1.21 to 1.72 , p < 0.001 ; respectively ) .
RESULTS	Patients with METS and DM showed no difference for risk of total and HF death compared with patients with no METS and no DM ( HR : 1.03 , 95 % CI : 0.87 to 1.21 , p = 0.762 ; HR : 0.99 ; 95 % CI : 0.73 to 1.35 ; p = 0.963 ; respectively ) .
CONCLUSIONS	METS is associated with reduced all-cause and HF mortality in patients with HF .
CONCLUSIONS	HF patients with DM without METS are at the highest risk of mortality , whereas METS attenuates mortality risk in HF patients with DM .

###25284142
BACKGROUND	The aim of this randomized , crossover study was to determine if transoral fundoplication ( TF ) could further improve clinical outcomes in partial responders to high-dose ( HD ) proton-pump inhibitor ( PPI ) therapy and to evaluate durability of TF .
METHODS	In seven United States centers , patients with hiatal hernia 2 cm and abnormal esophageal acid exposure ( EAE ) were randomized to TF ( n = 40 ) or HD PPIs ( n = 23 ) group .
METHODS	At 6-month follow-up , PPI patients underwent crossover .
METHODS	We assessed clinical outcomes 6-month post TF in crossover patients ( COP ) , as compared to 6-month of HD PPI therapy , and 12-month outcomes in patients initially randomized to TF .
METHODS	The primary outcome was symptom control evaluated by Reflux Disease Questionnaire and Reflux Symptom Index .
METHODS	Secondary outcomes included healing of esophagitis , normalization of EAE and PPI use after TF .
METHODS	We analyzed 21 COP and 39 TF patients .
METHODS	McNemar 's test or Fisher exact test was used to compare proportions .
RESULTS	Of 63 randomized patients , 3 were lost to follow-up , leaving 39 TF and 21 COP for analyses .
RESULTS	In the COP , TF further improved control of regurgitation and of atypical symptoms achieved after six months of HD PPIs .
RESULTS	Of 20 patients with GERD symptoms after six months of high-dose PPI therapy , 65 % ( 13/20 ) reported global elimination of troublesome regurgitation and atypical symptoms post TF off PPIs ; 67 % ( 6/9 ) reported no troublesome regurgitation .
RESULTS	Esophagitis further healed in 75 % ( 6/8 ) of patients .
RESULTS	Seventy-one percent of COP patients were off PPIs six months following TF .
RESULTS	Normalization of EAE decreased from 52 % after HD PPIs ( on PPIs ) to 33 % after TF ( off PPIs ) , p = 0.388 .
RESULTS	In the original TF group , 12-month post TF , 77 % of patients achieved complete symptom control , 82 % ceased PPI therapy , 100 % healed esophagitis and 45 % normalized EAE .
CONCLUSIONS	The results of this study indicate that in patients with incomplete symptom control on high-dose PPI therapy TF may provide further elimination of symptoms and esophagitis healing .
CONCLUSIONS	In the original TF group , the clinical outcomes of TF remained stable between 6 - and 12-month follow-up .

###25959848
BACKGROUND	Sepsis bundles can decrease mortality in patients with severe sepsis or septic shock .
BACKGROUND	However , current methods of measuring pressure , such as central venous pressure , are inadequate .
BACKGROUND	This study investigated the effect of improved sepsis bundles informed by pulse-indicated continuous cardiac output .
METHODS	We compared the outcome of treatment with sepsis bundles informed by either conventional pressure measurements or pulse-indicated continuous cardiac output .
METHODS	Patients in 2 groups received fluid resuscitation , standard antibiotics , and oxygen therapy .
RESULTS	A total of 105 patients with septic shock were randomly divided into 2 groups : the conventional sepsis bundle group ( n = 52 ) or the improved sepsis bundle group ( ISBG , n = 53 ) .
RESULTS	The ISBG significantly reduced the mean Acute Physiology and Chronic Health Evaluation II and Sepsis-related Organ Failure Assessment scores .
RESULTS	Significantly fewer ISBG-treated patients received vasoactive drugs compared to conventional sepsis bundle group-treated patients .
RESULTS	In addition , patients in the ISBG exhibited a significantly increased arterial blood lactate clearance rate and required less total fluid resuscitation and a shorter duration of mechanical ventilation and stay in the intensive care unit .
CONCLUSIONS	Pulse-indicated continuous cardiac output-directed sepsis bundles can reduce the severity of septic shock , provide more accurate fluid resuscitation , and reduce the duration of mechanical ventilation and stay in the intensive care unit .

###25281438
BACKGROUND	Pain is a common distressing adverse effect in the early postoperative period following caesarean section .
BACKGROUND	The aim of this study was to investigate the effect on postoperative pain , analgesic requirement and haemodynamic profile of placing a suprafacial bupivacaine-soaked absorbable gelatin sponge in the caesarean section wound .
METHODS	A total of 164 healthy patients scheduled to undergo general anaesthesia for elective caesarean section were randomised to a study group ( n = 81 ) or a control group ( n = 83 ) .
METHODS	In the study group , a bupivacaine-soaked absorbable gelatin sponge was placed subcutaneously in the caesarean section wound .
METHODS	Intramuscular diclofenac 75 mg was given to all patients at 8-h intervals during the first 24h .
METHODS	Postoperatively , visual analogue scale pain scores , requirement for pethidine and diclofenac and changes in blood pressure and heart rate were compared between groups .
RESULTS	Pain scores were lower in the study group compared to the control group at all assessments ( P < 0.001 ) .
RESULTS	During the first eight hours after surgery , fewer patients in the study group required rescue pethidine compared with the control group ( 4 vs. 33 , P < 0.001 ) .
RESULTS	In the study group , total opioid and diclofenac consumption was lower ( P < 0.001 ) , and blood pressure and heart rate were lower ( P < 0.001 ) compared to the control group .
CONCLUSIONS	Suprafascial wound placement of a bupivacaine-soaked absorbable gelatin sponge improved postoperative analgesia and decreased opioid consumption following caesarean section .

###25162920
BACKGROUND	Transfusion of erythrocytes stored for prolonged periods is associated with increased mortality .
BACKGROUND	Erythrocytes undergo hemolysis during storage and after transfusion .
BACKGROUND	Plasma hemoglobin scavenges endogenous nitric oxide leading to systemic and pulmonary vasoconstriction .
OBJECTIVE	We hypothesized that transfusion of autologous blood stored for 40 days would increase the pulmonary artery pressure in volunteers with endothelial dysfunction ( impaired endothelial production of nitric oxide ) .
OBJECTIVE	We also tested whether breathing nitric oxide before and during transfusion could prevent the increase of pulmonary artery pressure .
METHODS	Fourteen obese adults with endothelial dysfunction were enrolled in a randomized crossover study of transfusing autologous , leukoreduced blood stored for either 3 or 40 days .
METHODS	Volunteers were transfused with 3-day blood , 40-day blood , and 40-day blood while breathing 80 ppm nitric oxide .
RESULTS	The age of volunteers was 41 4 years ( mean SEM ) , and their body mass index was 33.4 1.3 kg/m ( 2 ) .
RESULTS	Plasma hemoglobin concentrations increased after transfusion with 40-day and 40-day plus nitric oxide blood but not after transfusing 3-day blood .
RESULTS	Mean pulmonary artery pressure , estimated by transthoracic echocardiography , increased after transfusing 40-day blood ( 18 2 to 23 2 mm Hg ; P < 0.05 ) but did not change after transfusing 3-day blood ( 17 2 to 18 2 mm Hg ; P = 0.5 ) .
RESULTS	Breathing nitric oxide decreased pulmonary artery pressure in volunteers transfused with 40-day blood ( 17 2 to 12 1 mm Hg ; P < 0.05 ) .
CONCLUSIONS	Transfusion of autologous leukoreduced blood stored for 40 days was associated with increased plasma hemoglobin levels and increased pulmonary artery pressure .
CONCLUSIONS	Breathing nitric oxide prevents the increase of pulmonary artery pressure produced by transfusing stored blood .
CONCLUSIONS	Clinical trial registered with www.clinicaltrials.gov ( NCT 01529502 ) .

###25258045
OBJECTIVE	To explore perceptions of spinal manipulative therapy and exercise among adults aged 65 years and older with chronic neck pain .
METHODS	Mixed methods study embedded within a randomized clinical trial .
METHODS	Interviews were conducted with 222 of 241 randomized clinical trial participants .
METHODS	They had a mean age of 72.2 years and they had neck pain of moderate severity and of 6 years mean duration .
METHODS	Semi-structured interviews were conducted at the completion of the 12 week intervention phase , during which participants received spinal manipulative therapy and exercise interventions .
METHODS	Interviews explored determinants of satisfaction with care , whether or not therapy was worthwhile , and what was liked and disliked about treatment .
METHODS	Interviews were recorded and transcribed ; content analysis was used to identify themes within responses .
RESULTS	Participants placed high value on their relationships with health care team members , supervision , individualized care , and the exercises and information provided as treatment .
RESULTS	Change in symptoms did not figure as prominently as social and process-related themes .
RESULTS	Percpetions of age , activities , and co-morbities influenced some seniors ' expectations of treatment results , and comorbidities impacted perceptions of their ability to participate in active care .
CONCLUSIONS	Relationship dynamics should be leveraged in clinical encounters to enhance patient satisfaction and perceived value of care .

###24425846
OBJECTIVE	Salivary gland tumors are mostly benign tumors .
OBJECTIVE	Whether a more conservative surgical approach at greater risk of recurrence , or a more radical intervention with an increased risk of facial paralysis is warranted is still under discussion .
OBJECTIVE	Our study addresses the opportunity for improving surgical outcome by employing platelet-rich plasma ( PRP ) gel at the surgical site .
METHODS	Twenty consecutive patients undergoing superficial parotidectomy were randomized and assigned to two groups , one with and one without PRP gel .
METHODS	Many parameters were evaluated after surgery and during follow-up , such as the duration of hospitalization , facial nerve deficit , onset of Frey 's syndrome , relapse , cosmetic results , presence of keloid or scar depressions , behavior of several facial muscles .
RESULTS	Our explorative analysis suggests a positive effect of PRP on surgical outcome in patients undergoing parotidectomy , whereas no negative effects were detected .
CONCLUSIONS	This work suggests that administration of PRP in patients undergoing parotidectomy is beneficial .

###25884187
BACKGROUND	There is a growing recognition that cancer not only affects the lives of the patients , but also the lives of their partners .
BACKGROUND	Partners of cancer patients are highly involved in the illness trajectory by providing informal care and they often experience distress .
BACKGROUND	However , supporting interventions for this group are scarce and existing interventions bear several limitations .
BACKGROUND	On the basis of the need for theory - and evidence-based supportive interventions for partners of cancer patients , the web-based self-help intervention Hold on , for each other has been developed .
BACKGROUND	This intervention is based on Acceptance and Commitment Therapy .
BACKGROUND	The primary objective of the RCT is to investigate the ( cost - ) effectiveness of the intervention .
BACKGROUND	Additional goals are ( 1 ) to examine if psychological flexibility , self-compassion , mastery , supportive behavior , posttraumatic growth and resilience are mediators of the intervention 's effects on the partners ' mental health ; ( 2 ) to examine the moderating effects of the socio demographics ( age , gender , education , working situation , family situation ) and disease-related characteristics of the patients ( sort of cancer , stage of disease , duration and treatment of cancer ) ; and ( 3 ) to investigate to what extend participants are satisfied with the intervention , which parts of the intervention are mostly used , and how adherent the users are .
METHODS	A three-armed randomized controlled trial ( RCT ) will be conducted to compare two versions of the intervention Hold on , for each other with a waiting list control condition .
METHODS	Both intervention conditions contain the same content and differ only with regard to the form of professional support ( personal support versus automatic support ) .
METHODS	Adult partners of cancer patients with mild to moderate depressive and anxiety symptoms , will be recruited through a multi-component strategy .
METHODS	Online measurements by self-assessment will be made on four measurement points ( prior to randomization ( baseline-measurement ) and 3 , 6 and 12 months after baseline ) .
CONCLUSIONS	When proven effective , Hold on , for each other can be an invaluable contribution to the healthcare system and it could be offered to all partners of cancer patients who are in need for additional support .
BACKGROUND	Dutch Trial Register , trial registration number NTR4035 , date of registration : 17 March 2013 .

###25963675
BACKGROUND	Ensuring an open airway during cardiopulmonary resuscitation is fundamental .
BACKGROUND	The aim of this study was to determine the success rate of blind intubation during simulated cardiopulmonary resuscitation by untrained personnel .
METHODS	Four devices were compared in a simulated resuscitation scenario : ILMA ( Intavent Direct Ltd , Buckinghamshire , United Kingdom ) , Cobra PLA ( Engineered Medical Systems Inc , Indianapolis , IN ) , Supraglottic Airway Laryngopharyngeal Tube ( SALT ) ( ECOLAB , St. Paul , MN ) , and Air-Q ( Mercury Medical , Clearwater , FL ) .
METHODS	A group of 210 paramedics intubated a manikin with continuous chest compressions .
RESULTS	The mean times to intubation were 40.46 4.64 , 33.96 6.23 , 17.2 4.63 , and 49.23 13.19 seconds ( SALT vs ILMA , Cobra PLA , and Air-Q ; P < .05 ) .
RESULTS	The success ratios of blind intubation for the devices were 86.7 % , 85.7 % , 100 % , and 71.4 % ( SALT vs ILMA , Cobra PLA , and Air-Q ; P < .05 ) .
CONCLUSIONS	The study showed that the most efficient device with the shortest blind intubation time was the SALT device .

###25024234
BACKGROUND	Few scientific studies have examined movement-based embodied contemplative practices such as yoga and their effects on cognition .
BACKGROUND	The purpose of this randomized controlled trial was to examine the effects of an 8-week Hatha yoga intervention on executive function measures of task switching and working memory capacity .
METHODS	Community-dwelling older adults ( N = 118 ; mean age = 62.0 ) were randomized to one of two groups : a Hatha yoga intervention or a stretching-strengthening control .
METHODS	Both groups participated in hour-long exercise classes 3/week over the 8-week study period .
METHODS	All participants completed established tests of executive function including the task switching paradigm , n-back and running memory span at baseline and follow-up .
RESULTS	Analysis of covariances showed significantly shorter reaction times on the mixed and repeat task switching trials ( partial ( 2 ) = .04 , p < .05 ) for the Hatha yoga group .
RESULTS	Higher accuracy was recorded on the single trials ( partial ( 2 ) = .05 , p < .05 ) , the 2-back condition of the n-back ( partial ( 2 ) = .08 , p < .001 ) , and partial recall scores ( partial ( 2 ) = .06 , p < .01 ) of running span task .
CONCLUSIONS	Following 8 weeks of yoga practice , participants in the yoga intervention group showed significantly improved performance on the executive function measures of working memory capacity and efficiency of mental set shifting and flexibility compared with their stretching-strengthening counterparts .
CONCLUSIONS	Although the underlying mechanisms need to be investigated , these results demand larger systematic trials to thoroughly examine effects of yoga on executive function as well as across other domains of cognition , and its potential to maintain or improve cognitive functioning in the aging process .

###24622243
BACKGROUND	Soluble ST2 ( sST2 ) , a biomarker related to inflammation , is associated with outcomes of patients with heart failure .
BACKGROUND	In-depth analyses of the relationship among sST2 , changes in sST2 , and patient outcomes are reported .
RESULTS	sST2 was measured at baseline ( n = 1650 ) , 4 months ( n = 1345 ) , and 12 months ( n = 1094 ) in Valsartan Heart Failure Trial .
RESULTS	Baseline sST2 averaged 28.716.2 ng/mL , significantly ( P < 0.001 ) higher in men than women but supranormal in only 9 % and 15 % , respectively .
RESULTS	A continuous relationship between sST2 and the log hazard ratio for outcomes was modeled as 2 linear segments with a significant decrease in the rate of increase in hazard ratios > 33.2 ng/mL .
RESULTS	Each segment of the sST2 distribution was significantly ( P < 0.0001 ) associated with the risks of morbid event , mortality , and hospitalization for heart failure .
RESULTS	Only sST2 values < 33.2 ng/mL were significantly related to the outcomes when 23 readily available clinical variables including N-terminal probrain natriuretic peptide were included in the Cox regression model .
RESULTS	sST2 did not improve discrimination of patient outcomes .
RESULTS	Compared with placebo , valsartan significantly ( P < 0.001 ) reduced the rate of increase in sST2 .
RESULTS	Increases in sST2 for 12 months , but not decreases , were significantly associated with subsequent outcomes , independent of clinical variables , sST2 , and valsartan treatment .
CONCLUSIONS	In this study , baseline sST2 was nonlinearly associated with patient outcomes but did not provide substantial prognostic information when added to a clinical prediction model that included N-terminal probrain natriuretic peptide .
CONCLUSIONS	An increase but not decrease in sST2 was independently associated with outcomes .
CONCLUSIONS	Additional research is needed to determine whether monitoring ST2 levels can improve patient outcomes .

###24473372
BACKGROUND	The aim of the present study was to compare the effects of preemptive intravenous tenoxicam and methylprednisolone administrations on extraction of impacted third molars .
METHODS	This was a placebo-controlled , randomized , double-blind , clinical trial .
METHODS	A total of 60 adult patients ages 18-40 years with the complaints of impacted third molar teeth were included in the study .
RESULTS	The postoperative swelling ratios ( p < 0.05 ) and pain scores ( p < 0.05 ) were significantly better in both study groups than in the control group and there was no statistically significant difference between methylprednisolone and tenoxicam groups with regards to the edema and pain relief .
CONCLUSIONS	Preoperative administration of 80 mg methylprednisolone achieves better control of trismus than tenoxicam without any significant differences in edema and pain control in impacted third molar teeth extraction .

###24898300
OBJECTIVE	GLP-1 receptor agonists may provide an alternative to prandial insulin for advancing basal insulin therapy .
OBJECTIVE	Harmony 6 was a randomized , open-label , active-controlled trial testing once-weekly albiglutide vs. thrice-daily prandial insulin lispro as an add-on to titrated once-daily insulin glargine .
METHODS	Patients taking basal insulin ( with or without oral agents ) with HbA1c 7-10 .5 % ( 53-91 mmol/mol ) entered a glargine standardization period , followed by randomization to albiglutide , 30 mg weekly ( n = 282 ) , subsequently uptitrated to 50 mg , if necessary , or thrice-daily prandial lispro ( n = 281 ) while continuing metformin and/or pioglitazone .
METHODS	Glargine was titrated to fasting plasma glucose of < 5.6 mmol/L , and lispro was adjusted based on glucose monitoring .
METHODS	The primary end point was the difference in the HbA1c change from baseline at week 26 .
RESULTS	At week 26 , HbA1c decreased from baseline by -0.82 SE 0.06 % ( 9.0 mmol/mol ) with albiglutide and -0.66 0.06 % ( 7.2 mmol/mol ) with lispro ; treatment difference , -0.16 % ( 95 % CI -0.32 to 0.00 ; 1.8 mmol/mol ; P < 0.0001 ) , meeting the noninferiority end point ( margin , 0.4 % ) .
RESULTS	Weight decreased with albiglutide but increased with lispro ( -0.73 0.19 kg vs. +0.81 0.19 kg ) .
RESULTS	The mean glargine dose increased from 47 to 53 IU ( albiglutide ) and from 44 to 51 IU ( lispro ) .
RESULTS	Adverse events for albiglutide versus lispro included severe hypoglycemia ( 0 vs. 2 events ) , documented symptomatic hypoglycemia ( 15.8 % vs. 29.9 % ) , nausea ( 11.2 % vs. 1.4 % ) , vomiting ( 6.7 % vs. 1.4 % ) , and injection site reactions ( 9.5 % vs. 5.3 % ) .
CONCLUSIONS	Weekly albiglutide is a simpler therapeutic option than thrice-daily lispro for advancing basal insulin glargine therapy , resulting in comparable HbA1c reduction with weight loss and lower hypoglycemia risk .

###24614694
BACKGROUND	To present the long-term results of a prostate cancer ( PC ) screening trial conducted in a Mediterranean setting .
METHODS	A total of 4276 men aged 45-70 years were randomized to screening arm ( PSA test performed ) and control arm ( no tests ) .
METHODS	Transrectal ultrasonography-guided sextant prostate biopsy was conducted when PSA > or = 3ngml ( -1 ) .
METHODS	Date and cause of death were retrieved from death certificates .
METHODS	PC incidence , and disease-specific and overall mortality curves were plotted and comparison between arms was made .
METHODS	Analysis of causes of death was also performed .
RESULTS	Median age at randomization was 57.0 years .
RESULTS	Median follow-up time was 15.2 years .
RESULTS	A total of 241 men were diagnosed with PC , 161 ( 6.7 % ) in the screening arm and 80 ( 4.3 % ) in the control arm ( P < 0.01 ) .
RESULTS	Eventually , 554 men ( 13 % ) died .
RESULTS	No difference in all-cause mortality was found between arms ( P = 0.34 ) .
RESULTS	Only 10 men ( 10/4276 , 0.23 % ) died from PC , no differences between arms ( P = 0.67 ) .
RESULTS	Overall , the main causes of death were malignancy ( 54.2 % ) , cardiovascular ( 17.9 % ) and respiratory ( 9.2 % ) diseases .
RESULTS	Main cancer causes of death were lung and bronchus cancer ( 37.2 % ) , colorectum ( 15.0 % ) and stomach ( 9.0 % ) cancer .
RESULTS	PC only accounted for 3.0 % of all malignant causes of death ( ranked 10th ) .
CONCLUSIONS	Our study failed to demonstrate benefits of PC screening in terms of all-cause and PC-specific mortality after a median follow-up of 15 years .
CONCLUSIONS	The limited sample size and the low long-term PC mortality observed in our setting were probably the most important factors to explain these results .

###24692481
OBJECTIVE	The pathogenesis of perihematoma edema in intracerebral hemorrhage ( ICH ) is unknown but has been hypothesized to be ischemic .
OBJECTIVE	In the ICH Acutely Decreasing Arterial Pressure Trial ( ICH ADAPT ) , perihematoma cerebral blood flow ( CBF ) was reduced but was unaffected by blood pressure ( BP ) reduction .
OBJECTIVE	Using ICH ADAPT data , we tested the hypotheses that edema growth is associated with reduced CBF and lower systolic BP .
METHODS	Noncontrast computed tomographic scans in patients with ICH were obtained at baseline , 2 hours , and 24 hours after randomization to target systolic BPs of < 150 or < 180 mm Hg .
METHODS	Computed tomography perfusion imaging was performed at 2 hours , and mean relative CBF was calculated in visibly edematous perihematoma tissue .
METHODS	Edema volumes were measured using a Hounsfield unit threshold of 5 to 23 at each time-point .
RESULTS	Patients were randomized at a median ( interquartile range ) of 7.4 ( 12.8 ) hours after onset .
RESULTS	Treatment groups ( n = 34 , < 150 and n = 33 , < 180 target ) were balanced with respect to baseline systolic BP and acute ICH volume .
RESULTS	Relative edema growth at 24 hours in the < 150 group ( 0.110.19 ) was similar to that in the < 180 group ( 0.090.16 mL ; P = 0.727 ) .
RESULTS	Absolute CBF was lower in the edematous region ( 35.6713.1 mL/100 g per minute ) when compared with that in the contralateral tissue ( 43.711.7 mL/100 g per minute ; P < 0.0001 ) .
RESULTS	Linear regression indicated that neither systolic BP change ( = -0.022 ; 95 % confidence interval , -0.002 to 0.001 ) nor perihematoma relative CBF ( = -0.144 ; 95 % confidence interval , -0.647 to 0.167 ) predicted edema growth .
CONCLUSIONS	Lower perihematoma CBF and BP treatment do not exacerbate edema growth .
CONCLUSIONS	These data do not support a cytotoxic edema pathogenesis .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00963976 .

###24766974
BACKGROUND	Despite their wide use , whether antiarrhythmic drugs improve survival after out-of-hospital cardiac arrest ( OHCA ) is not known .
BACKGROUND	The ROC-ALPS is evaluating the effectiveness of these drugs for OHCA due to shock-refractory ventricular fibrillation or pulseless ventricular tachycardia ( VF/VT ) .
METHODS	ALPS will randomize 3,000 adults across North America with nontraumatic OHCA , persistent or recurring VF/VT after 1 shock , and established vascular access to receive up to 450 mg amiodarone , 180 mg lidocaine , or placebo in the field using a double-blind protocol , along with standard resuscitation measures .
METHODS	The designated target population is all eligible randomized recipients of any dose of ALPS drug whose initial OHCA rhythm was VF/VT .
METHODS	A safety analysis includes all randomized patients regardless of their eligibility , initial arrhythmia , or actual receipt of ALPS drug .
METHODS	The primary outcome of ALPS is survival to hospital discharge ; a secondary outcome is functional survival at discharge assessed as a modified Rankin Scale score 3 .
RESULTS	The principal aim of ALPS is to determine if survival is improved by amiodarone compared with placebo ; secondary aim is to determine if survival is improved by lidocaine vs placebo and/or by amiodarone vs lidocaine .
RESULTS	Prioritizing comparisons in this manner acknowledges where differences in outcome are most expected based on existing knowledge .
RESULTS	Each aim also represents a clinically relevant comparison between treatments that is worth investigating .
CONCLUSIONS	Results from ALPS will provide important information about the choice and value of antiarrhythmic therapies for VF/VT arrest with direct implications for resuscitation guidelines and clinical practice .

###24299462
BACKGROUND	Renal dysfunction is associated with a variety of cardiac alterations including left ventricular ( LV ) hypertrophy , LV dilation , and reduction in systolic and diastolic function .
BACKGROUND	It is common and associated with an increased mortality risk in heart failure ( HF ) patients .
BACKGROUND	This study was designed to evaluate whether severe diastolic dysfunction contribute to the increased mortality risk observed in HF patients with renal dysfunction .
METHODS	Using Cox Proportional Hazard Models on data ( N = 669 ) from the EchoCardiography and Heart Outcome Study ( ECHOS ) study we evaluated whether estimated glomerular filtration rate ( eGFR ) was associated with mortality risk before and after adjustment for severe diastolic dysfunction .
METHODS	Severe diastolic dysfunction was defined by a restrictive left ventricular filling pattern ( RF ) ( = deceleration time < 140 ms ) by Doppler echocardiography .
RESULTS	Median eGFR was 58 ml/min/1 .73 m , left ventricular ejection fraction was 33 % and RF was observed in 48 % .
RESULTS	During the 7 year follow up period 432 patients died .
RESULTS	Multivariable adjusted eGFR was associated with similar mortality risk before ( Hazard Ratio ( HR ) ( eGFR 10 ml increase ) : 0.94 ( 95 % CI : 0.89-0 .99 , P = 0.024 ) and after ( HR ( eGFR 10 ml increase ) : 0.93 ( 0.89-0 .99 ) , P = 0.012 ) adjustment for RF ( HR : 1.57 ( 1.28-1 .93 ) , P < 0.001 ) .
CONCLUSIONS	In patients admitted with HF RF does not contribute to the increased mortality risk observed in patients with a decreased eGFR .
CONCLUSIONS	Factors other than severe diastolic dysfunction may explain the association between renal function and mortality risk in HF patients .

###24633208
OBJECTIVE	We investigated phenotypic and genotypic resistance after 2 years of first-line therapy with two HIV treatment regimens in the absence of virological monitoring .
METHODS	NORA [ Nevirapine OR Abacavir study , a sub-study of the Development of AntiRetroviral Therapy in Africa ( DART ) trial ] randomized 600 symptomatic HIV-infected Ugandan adults ( CD4 cell count < 200 cells/mm ( 3 ) ) to receive zidovudine/lamivudine plus abacavir ( cABC arm ) or nevirapine ( cNVP arm ) .
METHODS	All virological tests were performed retrospectively , including resistance tests on week 96 plasma samples with HIV RNA levels 1000 copies/mL .
METHODS	Phenotypic resistance was expressed as fold-change in IC ( 50 ) ( FC ) relative to wild-type virus .
RESULTS	HIV-1 RNA viral load 1000 copies/mL at week 96 was seen in 58/204 ( 28.4 % ) cABC participants and 21/159 ( 13.2 % ) cNVP participants .
RESULTS	Resistance results were available in 35 cABC and 17 cNVP participants ; 31 ( 89 % ) cABC and 16 ( 94 % ) cNVP isolates had a week 96 FC below the biological cut-off for tenofovir ( 2.2 ) .
RESULTS	In the cNVP arm , 16/17 participants had resistance mutations synonymous with high-level resistance to nevirapine and efavirenz ; FC values for etravirine were above the biological cut-off in 9 ( 53 % ) isolates .
RESULTS	In multivariate regression models , K65R , Y115F and the presence of thymidine analogue-associated mutations were associated with increased susceptibility to etravirine in the cABC arm .
CONCLUSIONS	Our data support the use of tenofovir following failure of a first-line zidovudine-containing regimen and shed further light on non-nucleoside reverse transcriptase inhibitor hypersusceptibility .

###25455116
BACKGROUND	Missed opportunities for human papilloma virus ( HPV ) vaccination are common , presenting a barrier to achieving widespread vaccine coverage and preventing infection .
OBJECTIVE	To compare the impact of clinician - versus family-focused decision support , none , or both on captured opportunities for HPV vaccination .
METHODS	Twelve-month cluster randomized controlled trial conducted in 2010-2011 .
METHODS	Adolescent girls aged 11-17 years due for HPV Dose 1 , 2 , or 3 receiving care at primary care practices .
METHODS	Twenty-two primary care practices were cluster randomized to receive a three-part clinician-focused intervention ( educational sessions , electronic health record-based alerts , and performance feedback ) or none .
METHODS	Within each practice , girls were randomized at the patient level to receive family-focused , automated , educational phone calls or none .
METHODS	Randomization resulted in four groups : clinician-focused , family-focused , combined , or no intervention .
METHODS	Standardized proportions of captured opportunities ( due vaccine received at clinician visit ) were calculated among girls in each study arm .
METHODS	Analyses were conducted in 2013 .
RESULTS	Among 17,016 adolescent girls and their 32,472 visits ( 14,247 preventive , 18,225 acute ) , more HPV opportunities were captured at preventive than acute visits ( 36 % vs 4 % , p < 0.001 ) .
RESULTS	At preventive visits , the clinician intervention increased captured opportunities by 9 percentage points for HPV-1 and 6 percentage points for HPV-3 ( p0 .01 ) , but not HPV-2 .
RESULTS	At acute visits , the clinician and combined interventions significantly improved captured opportunities for all three doses ( p0 .01 ) .
RESULTS	The family intervention was similar to none .
RESULTS	Results differed by practice setting ; at preventive visits , the clinician intervention was more effective for HPV-1 in suburban than urban settings , whereas at acute visits , the clinician intervention was more effective for all doses at urban practices .
CONCLUSIONS	Clinician-focused decision support is a more effective strategy than family-focused to prevent missed HPV vaccination opportunities .
CONCLUSIONS	Given the persistence of missed opportunities even in intervention groups , complementary strategies are needed .
CONCLUSIONS	This study is registered at clinicaltrials.gov NCT01159093 .

###24251881
OBJECTIVE	Short periods of muscle disuse , due to illness or injury , result in substantial skeletal muscle atrophy .
OBJECTIVE	Recently , we have shown that a single session of neuromuscular electrical stimulation ( NMES ) increases muscle protein synthesis rates .
OBJECTIVE	The aim was to investigate the capacity for daily NMES to attenuate muscle atrophy during short-term muscle disuse .
METHODS	Twenty-four healthy , young ( 23 1 year ) males participated in the present study .
METHODS	Volunteers were subjected to 5 days of one-legged knee immobilization with ( NMES ; n = 12 ) or without ( CON ; n = 12 ) supervised NMES sessions ( 40-min sessions , twice daily ) .
METHODS	Two days prior to and immediately after the immobilization period , CT scans and single-leg one-repetition maximum ( 1RM ) strength tests were performed to assess quadriceps muscle cross-sectional area ( CSA ) and leg muscle strength respectively .
METHODS	Furthermore , muscle biopsies were taken to assess muscle fibre CSA , satellite cell content and mRNA and protein expression of selected genes .
RESULTS	In CON , immobilization reduced quadriceps CSA by 3.5 0.5 % ( P < 0.0001 ) and muscle strength by 9 2 % ( P < 0.05 ) .
RESULTS	In contrast , no significant muscle loss was detected following immobilization in NMES although strength declined by 7 3 % ( P < 0.05 ) .
RESULTS	Muscle MAFbx and MuRF1 mRNA expression increased following immobilization in CON ( P < 0.001 and P = 0.07 respectively ) , whereas levels either declined ( P < 0.01 ) or did not change in NMES , respectively .
RESULTS	Immobilization led to an increase in muscle myostatin mRNA expression in CON ( P < 0.05 ) , but remained unchanged in NMES .
CONCLUSIONS	During short-term disuse , NMES represents an effective interventional strategy to prevent the loss of muscle mass , but it does not allow preservation of muscle strength .
CONCLUSIONS	NMES during disuse may be of important clinical relevance in both health and disease .

###24487733
BACKGROUND	Compared with goal-directed crystalloid therapy , goal-directed colloid therapy during high-risk surgery may improve postoperative outcome .
BACKGROUND	Whether intraoperative fluid therapy based on goal-directed protocol with different types of fluid has distinctive effects on brain relaxation and cerebral metabolism during craniotomy remains unclear .
METHODS	Forty patients with supratentorial brain tumors undergoing craniotomy were randomly assigned to either a Ringer 's Lactate-based goal-directed group ( LR group , n = 20 ) or a 6 % hydroxyethyl starch-based goal-directed group ( HES group , n = 20 ) .
METHODS	The goal was achieved by maintaining a target stroke volume variation ( SVV < 13 % ) by volume loading with LR or HES throughout the procedure .
METHODS	The primary outcome is brain relaxation scales , an indirect evaluation of ICP ; secondary endpoints include cerebral metabolism variables ( jugular venous oxygen saturation [ SjvO ( 2 ) ] , arterial-jugular venous differences in oxygen [ CajvO ( 2 ) ] , glucose [ A-JvGD ] , lactate [ A-JvLD ] , and cerebral extraction ratio for oxygen [ CERO ( 2 ) ] ) and fluid volumes .
RESULTS	There is no significant difference between the LR and HES groups on brain relaxation scales ( P = 0.845 ) , or measures of cerebral oxygenation and metabolism .
RESULTS	Intragroup comparisons showed that CERO ( 2 ) increased by 14.3 % ( P = 0.009 , LR group ) and 13.2 % ( P = 0.032 , HES group ) , respectively , and SjvO ( 2 ) was decreased by 8.8 % ( P = 0.016 , LR group ) and 8.1 % ( P = 0.026 , HES group ) , respectively , after tumor removal , compared with baseline .
RESULTS	During surgery , the LR group ( 30701138 mL ) received more fluid than the HES group ( 2041758 mL , P = 0.002 ) .
CONCLUSIONS	In patients undergoing supratentorial tumor resection , goal-directed HES therapy was not superior to goal-directed LR therapy for brain relaxation or cerebral metabolism , although less fluid was needed to maintain the target SVV in the HES-based group than in the LR-based group .

###24697925
BACKGROUND	Clefting of the lip , palate , or both is a common congenital abnormality .
BACKGROUND	Inadequate treatment for pain in children may result from concerns over opioid-related adverse effects .
BACKGROUND	Providing adequate pain control with minimal adverse effects remains challenging in children .
OBJECTIVE	To assess opioid-sparing effects of oral or intravenous acetaminophen following primary cleft palate repair in children .
METHODS	Prospective randomized controlled trial in 45 healthy children , ages 5months to 5years , using standardized general anesthesia and lidocaine infiltration of the operative field .
METHODS	Patients were allocated to groups : intravenous acetaminophen/oral placebo ( intravenous ) , oral acetaminophen/intravenous placebo ( oral ) , or intravenous/oral placebo ( control ) .
METHODS	Groups were compared for differences in opioid administration during the 24-h study period ( morphine equivalents gkg ( -1 ) ; 95 % confidence interval ) .
RESULTS	Intravenous acetaminophen decreased opioid requirement after surgery ( P = 0.003 ) .
RESULTS	Patients in the intravenous group received less opioid ( 272.9 ; 202.9-342 .8 gkg ( -1 ) ) than control patients ( 454.2 ; 384.3-524 .2 gkg ( -1 ) ; P < 0.002 ) .
RESULTS	Opioid requirement in oral patients ( 376.5 ; 304.1-448 .9 gkg ( -1 ) ) was intermediate and not significantly different from either intravenous ( P = 0.11 ) or control ( P = 0.27 ) .
RESULTS	During the ward phase of care , intravenous had better analgesia than control ( P = 0.002 ) , and both intravenous and oral group patients received less opioid than control ( P = 0.01 ) .
CONCLUSIONS	Intravenous acetaminophen given to young children undergoing primary cleft palate repair was associated with opioid-sparing effects compared to placebo .
CONCLUSIONS	The fewer morphine doses during ward stay in both intravenous and oral may be important clinically in some settings .

###24932858
OBJECTIVE	The aim of the study was to evaluate the durability of efficacy of the Integrated Care ( IC ) program in a Swedish context .
OBJECTIVE	The IC program is a person-centered flexible assertive community treatment approach delivered through a novel mechanism : a resource group clinical microsystem for each patient .
METHODS	All patients with schizophrenia in a Gothenburg urban-sector catchment area were randomly assigned to either the IC or the Rational Rehabilitation ( RR ) programs .
METHODS	Sixty-six patients were interviewed and assessed by independent interviewers before treatment , after treatment ( 24 months ) , and at follow-up ( five years ) .
METHODS	Analysis was by intention to treat .
RESULTS	At the five-year follow-up , significant improvements were noted in social functioning and consumer satisfaction in the IC group ( N = 35 ) compared with the RR group ( N = 31 ) .
RESULTS	No patients were lost to services in either program .
CONCLUSIONS	The major finding was the durability of efficacy of the IC program .

###24222372
BACKGROUND	Statins are known to possess pleiotropic anti-inflammatory properties which have been evaluated for clinical benefits in a number of disorders .
BACKGROUND	Studies have demonstrated beneficial actions of statins in experimental models of colitis .
BACKGROUND	Clinical evidence in acute exacerbation of ulcerative colitis ( UC ) is lacking .
OBJECTIVE	This study aims to assess the efficacy and safety of add-on atorvastatin in mild to moderately severe acute exacerbation of UC .
METHODS	Patients with acute exacerbation of UC were randomized to receive either atorvastatin ( 20 mg ) or matching placebo once daily orally for 8 weeks in addition to the standard therapy .
METHODS	Clinical efficacy was assessed by using partial Mayo score ( PMS ) .
RESULTS	Previously diagnosed 64 cases of UC presenting with mild to moderately severe acute exacerbation were randomized to receive either atorvastatin of 20 mg or placebo .
RESULTS	Mean PMS increased by 1.5 points and decreased by 0.31 points in atorvastatin and placebo groups , respectively , at 8 weeks compared to the baseline values ( p = 0.04 ) .
RESULTS	Eight ( 25 % ) and 13 ( 40.6 % ) patients attained the primary outcome criteria for clinical improvement in the atorvastatin and placebo arms , respectively ( p = 0.18 ) .
RESULTS	Fifteen ( 46.8 % ) patients in the atorvastatin group and no patient in the placebo group had 2 point increase in PMS after 8 weeks ( p < 0.001 ) .
CONCLUSIONS	Atorvastatin therapy in acute exacerbation of UC may not be associated with beneficial effects .
CONCLUSIONS	Paradoxical increase in disease activity may be seen in some patients .
CONCLUSIONS	However , these findings need to be substantiated in larger studies .

###24413724
BACKGROUND	The high prevalence of sleep disorders highlights the importance of its treatment in hemodialysis patients .
BACKGROUND	Due to complications of hypnotic medications , considering effective nonpharmacological methods to improve sleep quality is important .
BACKGROUND	This study has conducted to determine the effect of a sleep hygiene training program on sleep quality of hemodialysis patients .
METHODS	In a randomized controlled clinical trial , 82 hemodialysis patients were randomly selected and allocated to the intervention ( n = 41 ) and control ( n = 41 ) groups .
METHODS	A 1-month sleep hygiene program was provided to the intervention group within 6 sessions , and the sleep quality was assessed by the Pittsburgh Sleep Quality Index before and after the intervention .
METHODS	The global and components scores were compared between the two groups .
RESULTS	The mean global scores and component scores of sleep quality were not significantly different between the two groups before the intervention .
RESULTS	The mean global score of sleep quality of the intervention group significantly reduced after sleep hygiene education , as compared to the baseline values .
RESULTS	The mean global score of the intervention group was significantly lower than that of the control group after the intervention ( intervention , 9.92 + / - 3.80 versus control , 13.05 + / - 4.28 ) .
RESULTS	Also , the mean scores subjective sleep quality , sleep latency , sleep disturbances , and daytime dysfunction were significantly lower in the intervention group .
CONCLUSIONS	The findings of this study suggest that nursing and physicians team should consider reducing sleep problems of hemodialysis patients by training sleep hygiene .

###24892447
BACKGROUND	Decision aids may improve informed consent in clinical trial recruitment , but have not been evaluated in this context .
BACKGROUND	This study investigated whether decision aids ( DAs ) can reduce decisional difficulties among women considering participation in the International Breast Cancer Intervention Study-II ( IBIS-II ) trial .
METHODS	The IBIS-II trial investigated breast cancer prevention with anastrazole in two cohorts : women with increased risk ( Prevention ) , and women treated for ductal carcinoma in situ ( DCIS ) .
METHODS	Australia , New Zealand and United Kingdom participants were randomised to receive a DA ( DA group ) or standard trial consent materials ( control group ) .
METHODS	Questionnaires were completed after deciding about participation in IBIS-II ( post decision ) and 3 months later ( follow-up ) .
RESULTS	Data from 112 Prevention and 34 DCIS participants were analysed post decision ( 73 DA ; 73 control ) ; 95 Prevention and 24 DCIS participants were analysed at follow-up ( 58 DA ; 61 control ) .
RESULTS	There was no effect on the primary outcome of decisional conflict .
RESULTS	The DCIS-DA group had higher knowledge post decision , and the Prevention-DA group had lower decisional regret at follow-up .
CONCLUSIONS	This was the first study to evaluate a DA in the clinical trial setting .
CONCLUSIONS	The results suggest DAs can potentially increase knowledge and reduce decisional regret about clinical trial participation .

###25208357
OBJECTIVE	This randomized , single center , examiner-blind , controlled , parallel-group , 6-month clinical study compared the antiplaque/antigingivitis potential of an essential oil ( EO ) versus a 0.07 % cetylpyridinium chloride ( CPC ) - containing mouthrinse .
OBJECTIVE	A 5 % hydroalcohol solution was included as a control group .
METHODS	354 healthy volunteers ( 18-71 years of age ) were enrolled in this clinical trial ; 338 subjects completed the study .
METHODS	At baseline , 1 - , 3 - , and 6-month visits , subjects received an oral examination , gingivitis ( MGI ) , gingival bleeding ( BI ) and plaque assessments ( PI ) .
METHODS	Following randomization , subjects received a prophylaxis and began brushing twice daily with the provided fluoride toothpaste and rinsing twice daily with 20 mL of the assigned mouthrinse for 30 seconds .
RESULTS	All rinses were well tolerated by the subjects , with the exception of extrinsic tooth stain complaints in 13 subjects in the CPC group between the 3 - and 6-month exams .
RESULTS	Statistically significant reductions in gingivitis , bleeding and plaque were observed for both EO and CPC at all post-baseline time-points when compared to the negative control .
RESULTS	At 6 months MGI and PI were reduced by 42.6 % and 42.0 % for EO and by 17.1 % and 13.9 % respectively , for CPC vs. control .
RESULTS	When compared to CPC , EO was statistically significantly superior at all post-baseline time-points .
RESULTS	EO showed increasing reductions in MGI of 10.5 % , 20.3 % and 30.7 % as well as reductions in PI of 12.7 % , 23.7 % and 32.6 % at 1 , 3 and 6 months , respectively .
RESULTS	When analyzing the number of healthy sites ( MGI scores of 0 or 1 ) , the beneficial effect of the EO-containing mouthrinse is 45.8 % greater than using a CPC-containing mouthrinse and 59.8 % greater than placebo .

###25247335
BACKGROUND	Genome-wide association studies identified that insulin-like growth factor 2 mRNA-binding protein 2 ( IGF2BP2 ) genetic polymorphisms are related to type 2 diabetes mellitus ( T2DM ) in several populations .
BACKGROUND	This study aimed to investigate whether the IGF2BP2 gene rs1470579 and rs4402960 polymorphisms were associated with T2DM and pioglitazone efficacy in Chinese T2DM patients .
METHODS	A total of 281 T2DM patients and 111 healthy volunteers were enrolled to identify the IGF2BP2 gene rs1470579 and rs4402960 polymorphisms ; 86 patients were randomly selected and given a 12-week pioglitazone treatment ( 30 mg/day ) .
METHODS	Fasting plasma glucose , postprandial plasma glucose ( PPG ) , glycated hemoglobin , serum triglycerides ( TG ) , total cholesterol , low-density lipoprotein cholesterol and high-density lipoprotein cholesterol ( HDL-C ) were determined before and after pioglitazone treatment .
RESULTS	The results showed that the IGF2BP2 gene rs1470579 and rs4402960 polymorphisms were associated with T2DM in a Chinese population ( OR = 2.002 , 95 % CI 1.170-3 .426 , p < 0.05 ; OR = 1.879 , 95 % CI 1.110-3 .182 , p < 0.05 ) .
RESULTS	The effect of pioglitazone on PPG ( p < 0.05 ) , TG ( p < 0.01 ) and HDL-C ( p < 0.05 ) was lower in patients with the rs1470579 AC+CC genotypes than in AA genotype carriers .
RESULTS	Its effect on PPG level was also lower in patients with the GT+TT genotypes of rs4402960 than in patients with the GG genotype ( p < 0.05 ) .
CONCLUSIONS	The IGF2BP2 gene rs1470579 and rs4402960 polymorphisms were associated with T2DM and therapeutic efficacy of pioglitazone in this Chinese population .

###25224665
OBJECTIVE	The aim of this study was to evaluate the efficacy and safety of zoledronic acid ( ZA ) in the combination of docetaxel-based chemotherapy for castration-resistant prostate cancer with bone metastases .
METHODS	We conducted a prospective study in recruiting 105 prostate cancer patients with bone metastases from 2008 to 2010 .
METHODS	Patients were randomly divided into two groups , 53 in the docetaxel-based chemotherapy + ZA ( Group A ) and 52 in the docetaxel-based chemotherapy + placebo ( Group B ) .
METHODS	The different outcome between patients treated with chemotherapy combined with ZA and those with chemotherapy alone was evaluated .
METHODS	The Cox multivariate analyses of clinical features and different treatment methods of the 105 patients were conducted .
RESULTS	There was a response of prostate-specific antigen ( PSA ) in 33 ( 62.3 % ) in Group A and 28 ( 53.8 % ) in Group B ( P = 0.20 ) .
RESULTS	The combined approach group had better bone progression-free survival ( BPFS ) ( 9.0 vs. 6.0 months , P < 0.05 ) and overall survival ( OS ) ( 19.0 vs. 15.0 months , P = 0.02 ) , but no statistical evidence of benefit was observed in terms of PSA response .
RESULTS	Cox multivariate analysis identified the following independent prognostic factors : received ZA , high Hb level and more than 6 cycles of chemotherapy .
RESULTS	There were no clinical relevant differences in the frequencies of adverse events between these two groups .
CONCLUSIONS	Zoledronic acid treatment combined with docetaxel-based chemotherapy could have a better bone pain control and improve BPFS and OS for prostate cancer patients with bone metastases .
CONCLUSIONS	The PSA response and SREs rate are similar .

###24716847
OBJECTIVE	The aim of this study was to examine the effects of testosterone on verbal learning and memory in postmenopausal women .
METHODS	Randomized , placebo-controlled trial in which participants were randomized ( 1:1 ) to transdermal testosterone gel 300mcg/day , or identical placebo , for 26weeks .
METHODS	Ninety-two postmenopausal women aged 55-65years , on no systemic sex hormone therapy .
METHODS	The primary outcome was the score for the International Shopping List Task ( ISLT ) of CogState .
METHODS	Secondary outcomes included other CogState domains , the Psychological General Well-Being Index ( PGWB ) and safety variables .
RESULTS	Eighty-nine women , median age 60years , were included in the primary analysis .
RESULTS	Testosterone treatment resulted in statistically significantly better performance for the ISLT ( improved verbal learning and memory ) compared with placebo , adjusted for age and baseline score ( mean difference 157 ; 95 % CI 013 , 301 ) P = 003 ) .
RESULTS	There were no significant differences for other CogState domains or the PGWB scores .
RESULTS	At 26weeks , the median total testosterone was 17nm ( interquartile range ( IQR ) 11 , 24 ) in the testosterone group and 04nm ( IQR 03 , 05 ) in the placebo group .
CONCLUSIONS	The small but statistically significant effect of testosterone treatment on verbal learning and memory in postmenopausal women provides the basis for further clinical trials .

###25710565
OBJECTIVE	The objective was to determine the effect of preconception-initiated daily low-dose aspirin ( LDA ; 81 mg/day ) treatment on time to pregnancy in women with a history of pregnancy loss .
METHODS	This was a multicenter , block-randomized , double-blind , placebo-controlled trial .
METHODS	Participants were block-randomized by center and eligibility stratum .
METHODS	The study was conducted at four U.S.A. medical centers ( 2007-2012 ) .
METHODS	Participants women aged 18-40 years actively attempting pregnancy , stratified by eligibility criteria : the `` original '' stratum , women with one loss < 20 weeks ' gestation during the previous year ; and the `` expanded '' stratum , women with one or two previous losses of any gestational age regardless of time since loss .
METHODS	Daily LDA was compared with matching placebo for up to six menstrual cycles of attempting pregnancy .
METHODS	Time to hCG detected pregnancy and clinically confirmed pregnancy , analyzed by intention-to-treat , was measured .
RESULTS	Of the 1228 women randomly assigned to LDA ( n = 615 ) or placebo ( n = 613 ) , 410 ( 67 % ) women receiving LDA achieved pregnancy compared to 382 ( 63 % ) receiving placebo , corresponding to a fecundability odds ratio ( FOR ) of 1.14 ( 95 % CI : 0.97 , 1.33 ) .
RESULTS	Among women in the original stratum ( n = 541 ) , LDA was associated with increased fecundability compared to placebo ( FOR : 1.28 ; 95 % CI : 1.02 , 1.62 ) .
CONCLUSIONS	Preconception-initiated LDA treatment resulted in a nonsignificant increase in fecundability of 14 % in women with a history of 1-2 pregnancy losses , and a significant increase of 28 % in women with a history of only one pregnancy loss of < 20 weeks ' gestation in the preceding year .
CONCLUSIONS	Preconception-initiated LDA may increase fecundability in certain women with a recent early pregnancy loss .

###25385727
OBJECTIVE	Amrubicin , a third-generation anthracycline and potent topoisomerase II inhibitor , showed promising activity in small-cell lung cancer ( SCLC ) in phase II trials .
OBJECTIVE	This phase III trial compared the safety and efficacy of amrubicin versus topotecan as second-line treatment for SCLC .
METHODS	A total of 637 patients with refractory or sensitive SCLC were randomly assigned at a ratio of 2:1 to 21-day cycles of amrubicin 40 mg/m ( 2 ) intravenously ( IV ) on days 1 to 3 or topotecan 1.5 mg/m ( 2 ) IV on days 1 to 5 .
METHODS	Primary end point was overall survival ( OS ) ; secondary end points included overall response rate ( ORR ) , progression-free survival ( PFS ) , and safety .
RESULTS	Median OS was 7.5 months with amrubicin versus 7.8 months with topotecan ( hazard ratio [ HR ] , 0.880 ; P = .170 ) ; in refractory patients , median OS was 6.2 and 5.7 months , respectively ( HR , 0.77 ; P = .047 ) .
RESULTS	Median PFS was 4.1 months with amrubicin and 3.5 months with topotecan ( HR , 0.802 ; P = .018 ) .
RESULTS	ORR was 31.1 % with amrubicin and 16.9 % with topotecan ( odds ratio , 2.223 ; P < .001 ) .
RESULTS	Grade 3 treatment-emergent adverse events in the amrubicin and topotecan arms were : neutropenia ( 41 % v 54 % ; P = .004 ) , thrombocytopenia ( 21 % v 54 % ; P < .001 ) , anemia ( 16 % v 31 % ; P < .001 ) , infections ( 16 % v 10 % ; P = .043 ) , febrile neutropenia ( 10 % v 3 % ; P = .003 ) , and cardiac disorders ( 5 % v 5 % ; P = .759 ) ; transfusion rates were 32 % and 53 % ( P < .001 ) , respectively .
RESULTS	NQO1 polymorphisms did not influence safety outcomes .
CONCLUSIONS	Amrubicin did not improve survival when compared with topotecan in the second-line treatment of patients with SCLC .
CONCLUSIONS	OS did not differ significantly between treatment groups , although an improvement in OS was noted in patients with refractory disease treated with amrubicin .

###24519863
BACKGROUND	Essential hypertension is frequently associated with hyperuricemia in both adult and pediatric patients .
BACKGROUND	Lowering serum uric acid level may provide greater benefit than simply treating hypertension .
METHODS	Forty-four adolescents , aged 12-19years , newly diagnosed as essential hypertension ( secondary hypertension was excluded ) and previously untreated were randomized ( open label trial ) to receive either enalapril or enalapril plus allopurinol in combination .
METHODS	All participants had baseline serum uric acid level 5.5 mg/dl .
RESULTS	Baseline mean blood pressure ( BP ) , age and body mass index were similar between the two groups .
RESULTS	After 8weeks ' treatment , BP reduction was greater , percent of treatment group achieving target BP level was greater , and serum uric acid level was lower in the combination treatment group .
RESULTS	There were no adverse effects during the course of therapy .
CONCLUSIONS	Results suggest that uric acid reduction may be used as adjunctive antihypertensive therapy in hypertensive adolescents with hyperuricemia while closely monitoring for any adverse effect .

###25225951
OBJECTIVE	To investigate the effect of rhubarb combined with early enteral nutrition ( EEN ) on the gastrointestinal function , disease severity and systemic inflammation in patients with severe acute pancreatitis ( SAP ) .
METHODS	A total of 126 patients with SAP were randomly assigned into three groups : parenteral nutrition group , treated with standard solution first and EN 14 days later ; EEN group , treated with EN suspension ; or EEN combined with rhubarb group , treated with rhubarb and then EN 2 h later .
METHODS	The gastrointestinal function , APACHE II scores , the levels of plasma IL-6 , IL-11 , C-reactive proteins ( CRP ) and the liver and kidney functional measures were longitudinally analyzed .
RESULTS	Patients in the EEN/rhubarb group had the shortest period of abdominal pain and the fastest recovery from abnormal bowel movement and high fever as well as significantly shorter periods of intensive-care unit and hospital stays .
RESULTS	The combination of EEN and rhubarb significantly reduced the values of APACHE II scores .
RESULTS	Combination therapies significantly reduced abnormally higher white blood cell ( WBC ) counts and levels of plasma CRP and IL-6 , but increased the levels of plasma IL-11 .
RESULTS	Finally , combination therapies improved the SAP-related damages of liver and kidney function by reducing abnormally higher levels of plasma alanine aminotransferase , aspartate aminotransferase , and creatinine ( Cr ) .
CONCLUSIONS	Combination of EEN and rhubarb significantly improved the gastrointestinal function , inhibited systemic inflammation and disease severity and mitigated the disease-related damages of liver and kidney function in SAP patients .

###26281342
OBJECTIVE	Postoperative pain control constitutes a major problem and studies have focused on reducing opioid requirements using regional techniques .
OBJECTIVE	We aimed to investigate the efficacy of wound infiltration with lornoxicam on postoperative pain control following thyroidectomy .
METHODS	In this prospective , randomized-controlled study , 80 patients scheduled for thyroidectomy were randomly assigned to 2 groups .
METHODS	After the thyroidectomy was performed , patients in group I underwent wound infiltration with 4 mg of lornoxicam and patients in group II received the same amount of saline .
METHODS	Rescue analgesia was provided with additional doses oflornoxicam delivered by an on-demand patient-controlled analgesia device .
METHODS	Total analgesic consumption during the postoperative 24 h , and pain intensities assessed using a visual analog scale score at 0 , 2 , 4 , 8 , 12 and 24 h postoperatively were recorded .
RESULTS	Pain scores during the postoperative 24 h were slightly lower in group I than in group II , but the difference was not significant ( P > 0.05 ) .
RESULTS	The mean analgesic consumption was 8.87 1.87 mg and 10.33 1.25 mg in groups I and II , respectively ( P > 0.05 ) .
CONCLUSIONS	Wound infiltration with lornoxicam neither improved postoperative pain control nor decreased total analgesic consumption .

###25792354
BACKGROUND	The objective of this study was to determine the effect of inspiratory resistance through an impedance threshold device ( ITD ) on orthostatic tolerance in patients with postural tachycardia syndrome .
BACKGROUND	We hypothesized that the ITD would result in a greater negative intrathoracic pressure to enhance cardiac venous return , improve stroke volume , and reduce heart rate in these patients .
RESULTS	We compared the effect of a sham device ( sham , no resistance ) versus an ITD ( increased inspiratory resistance ) in 26 patients with postural tachycardia syndrome in a randomized , single-blind , crossover study .
RESULTS	Hemodynamic assessments were performed at baseline while supine and during head-up tilt to 70 for 10 minutes .
RESULTS	We did not find differences in baseline hemodynamic parameters between the ITD and the sham devices .
RESULTS	After 10 minutes of head-up tilt , the heart rate was lower with the ITD versus sham device ( 1024 versus 1094 beat/min , respectively ; P = 0.003 ) .
RESULTS	The ITD also improved stroke volume compared with the sham device ( 352 versus 261 mL ; P = 0.006 ) .
CONCLUSIONS	These findings suggest that increasing negative intrathoracic pressure with ITD breathing improves heart rate control in patients with postural tachycardia syndrome during upright posture .
BACKGROUND	clinicaltrials.gov ; Unique Identifier : NCT00962728 .

###25117425
OBJECTIVE	This prospective , randomized , single-centre study compared peginterferons alfa-2a and alfa-2b , combined with ribavirin , in treating patients infected with hepatitis C virus ( HCV ) genotype 1 .
METHODS	Hundred-and-one patients received 48 weeks of open-label treatment with peginterferon alfa-2a ( 180 g/week ) and 111 patients received peginterferon alfa-2b ( 1.5 g/kg/week ) .
METHODS	All patients received the same dose of ribavirin 1000/1200 mg/day , depending on weight .
METHODS	The primary efficacy endpoint was sustained virologic response ( SVR ) , defined as undetectable HCV RNA ( < 50 IU/mL ) 24 weeks after the end of treatment .
RESULTS	Early virologic response ( EVR ) , defined as at least 2 log IU/mL reduction of viral load at 12 weeks , was more common in patients treated with peginterferon alfa-2a ( 88 % vs. 74.8 % ; p = 0.04 ) .
RESULTS	However , the difference in SVR was not statistically significant ( 49.5 % vs. 44.1 % ; p = 0.43 ) .
CONCLUSIONS	Peginterferon alfa-2a treated patients were also more likely to be HCV RNA negative at the end of treatment ( 67.3 % vs. 57.7 % ) , but this difference did not reach statistical significance .
CONCLUSIONS	Multivariate logistic regression analysis found that SVR was associated with low fibrosis stage ( F1-2 by Scheuer ; p = 0.001 ) and low serum HCV RNA level ( < 400,000 IU/L ; p = 0.023 ) .
CONCLUSIONS	While both forms of peginterferon showed similar efficacy as measured by SVR , use of peginterferon alfa-2b could lower the number of patients receiving unnecessary treatment beyond 12 weeks .

###25381472
BACKGROUND	Trigger digit is one of the most common causes of pain and disability in the hand .
BACKGROUND	The mainstay of conservative treatment of this disease has been local steroid injection into the tendon sheath .
BACKGROUND	The aim of this study was to investigate the clinical benefit of an ultrasound-guided corticosteroid injection compared to a blinded application .
METHODS	74 patients , who suffered from persistent or increasing symptoms of a single trigger digit , were enroled in this prospective , randomised case-control study .
METHODS	All patients were treated with an injection of 40 mg/1 ml methylprednisolone acetate into the flexor tendon sheath at the level of the A1 pulley .
METHODS	Half of the patients had their injections under ultrasound control ( USG ) and half without ( blinded injection group , BIG ) .
METHODS	Associated metabolic diseases were recorded .
METHODS	At the 6-week and 6-month follow-up examinations , the complication rate and the need for a second injection were assessed .
METHODS	The outcome was rated using the Quinnell grading .
METHODS	The pain level was assessed using the visual analogue scale .
RESULTS	Four patients were excluded due to lack of follow-up .
RESULTS	Both study groups were comparable in respect of age , hand dominance and associated diseases .
RESULTS	There were significantly more female patients in the USG group ( 32 versus 23 % ) .
RESULTS	After the corticosteroid injections , all patients improved significantly in terms of pain level and the Quinnell grading at 6 weeks and 6 months after the intervention in comparison to the pre-injection status .
RESULTS	There were no significant differences between the groups .
RESULTS	9 patients ( 13 % ) needed a second injection ( 6 of BIG , 3 of USG ) , all of whom had diabetes mellitus .
RESULTS	No local complications were seen after the injections .
CONCLUSIONS	The use of ultrasound-guided injection of corticosteroid may be associated with extra time and effort , with no superior clinical benefits compared to the blinded technique .
METHODS	Level 1 ( prospective randomised study ) .

###25365551
OBJECTIVE	To assess changes in Ocular Response Analyzer ( ORA ) waveforms after UVA/riboflavin corneal collagen cross-linking ( CXL ) using investigator-derived and manufacturer-supplied morphometric variables in patients with keratoconus ( KC ) and postrefractive surgery ectasia .
METHODS	Prospective randomized trial of a standard epithelium-off CXL protocol .
METHODS	Patients with progressive KC ( 24 eyes of 21 patients ) or postrefractive surgery ectasia ( 27 eyes of 23 patients ) were enrolled .
METHODS	Replicate ORA measurements were obtained before and 3 months after CXL .
METHODS	Pretreatment and posttreatment waveform variables were analyzed for differences by paired Student t tests using measurements with the highest waveform scores .
METHODS	Corneal hysteresis , corneal resistance factor , 37-s generation manufacturer-supplied ORA variables , and 15 investigator-derived ORA variables .
RESULTS	No variables were significantly different 3 months after CXL in the KC group , and no manufacturer-supplied variables changed significantly in the postrefractive surgery ectasia group .
RESULTS	Four custom variables ( ApplanationOnsetTime , P1P2avg , Impulse , and Pmax ) increased by small but statistically significant margins after CXL in the postrefractive surgery ectasia group .
CONCLUSIONS	Changes in a small subset of investigator-derived variables suggested an increase in corneal bending resistance after CXL .
CONCLUSIONS	However , the magnitudes of these changes were low and not commensurate with the degree of clinical improvement or prior computational estimates of corneal stiffening in the same cohort over the same period .
CONCLUSIONS	Available air-puff-derived measures of the corneal deformation response underestimate the biomechanical changes produced by CXL .

###24646104
BACKGROUND	Denosumab 60 mg sc injection every 6 months for 36 months was well tolerated and effective in reducing the incidence of vertebral , nonvertebral , and hip fracture in predominantly Caucasian postmenopausal women with osteoporosis .
OBJECTIVE	The objective of this phase 3 fracture study was to examine the antifracture efficacy and safety of denosumab 60 mg in Japanese women and men with osteoporosis compared with placebo .
METHODS	A randomized , double-blind , placebo-controlled trial with an open-label active comparator as a referential arm was conducted .
METHODS	Subjects were 1262 Japanese patients with osteoporosis aged 50 years or older , who had one to four prevalent vertebral fractures .
METHODS	Subjects were randomly assigned to receive denosumab 60 mg sc every 6 months ( n = 500 ) , placebo for denosumab ( n = 511 ) , or oral alendronate 35 mg weekly ( n = 251 ) .
METHODS	All subjects received daily supplements of calcium and vitamin D.
METHODS	The primary endpoint was the 24-month incidence of new or worsening vertebral fracture for denosumab vs placebo .
RESULTS	Denosumab significantly reduced the risk of new or worsening vertebral fracture by 65.7 % , with incidences of 3.6 % in denosumab and 10.3 % in placebo at 24 months ( hazard ratio 0.343 ; 95 % confidence interval 0.194-0 .606 , P = .0001 ) .
RESULTS	No apparent difference in adverse events was found between denosumab and placebo during the first 24 months of the study .
CONCLUSIONS	These results provide evidence of the efficacy and safety of denosumab 60 mg sc every 6 months in Japanese subjects with osteoporosis .

###24274887
OBJECTIVE	To determine whether inoculation of healthy dogs with a recombinant peptide containing 3 copies of ACTH would result in the production of antibodies against ACTH and whether this would affect pituitary-adrenocortical function .
METHODS	8 healthy dogs .
METHODS	A recombinant peptide consisting of 3 copies of ACTH fused to a T-helper cell epitope was produced in Escherichia coli .
METHODS	The protein was inoculated into 4 dogs at 4-week intervals ( total of 3 inoculations/dog ) .
METHODS	Four control dogs received inoculations of PBS solution mixed with adjuvant .
METHODS	Blood samples were collected for determination of antibody titers against ACTH and for measurement of basal and ACTH-stimulated plasma cortisol concentrations .
RESULTS	Inoculation with the ACTH vaccine resulted in production of anti-ACTH antibodies in all 4 dogs .
RESULTS	Titers were initially high but declined by 15 weeks after the initial inoculation .
RESULTS	Basal cortisol concentrations were unaffected by inoculation with the ACTH vaccine .
RESULTS	Plasma cortisol concentrations in response to ACTH stimulation were reduced at 12 weeks , but not at 15 weeks , after the first inoculation .
CONCLUSIONS	Inoculation of dogs with a recombinant ACTH vaccine resulted in the production of antibodies against the hormone .
CONCLUSIONS	Anti-ACTH titers were initially high but were not sustained .
CONCLUSIONS	The only detectable endocrine effect in treated dogs was a reduction in cortisol concentration in response to ACTH stimulation in 2 of 4 dogs at 12 weeks after the first inoculation .
CONCLUSIONS	The effect of vaccine administration on the pituitary-adrenal system was subtle and transient .

###24502751
BACKGROUND	Many patients on maintenance dialysis experience significant sleepiness and fatigue .
BACKGROUND	However , the influence of the hemodialysis ( HD ) day and circadian rhythms on patients ' symptoms have not been well characterized .
BACKGROUND	We sought to use ecological momentary assessment to evaluate day-to-day and diurnal variability of fatigue , sleepiness , exhaustion and related symptoms in thrice-weekly maintenance HD patients .
METHODS	Subjects used a modified cellular phone to access an interactive voice response system that administered the Daytime Insomnia Symptom Scale ( DISS ) .
METHODS	The DISS assessed subjective vitality , mood , and alertness through 19 questions using 7 - point Likert scales .
METHODS	Subjects completed the DISS 4 times daily for 7 consecutive days .
METHODS	Factor analysis was conducted and a mean composite score of fatigue-sleepiness-exhaustion was created .
METHODS	Linear mixed regression models ( LMM ) were used to examine the association of time of day , dialysis day and fatigue , sleepiness , and exhaustion composite scores .
RESULTS	The 55 participants completed 1,252 of 1,540 ( 81 % ) possible assessments over the 7 day period .
RESULTS	Multiple symptoms related to mood ( e.g. , feeling sad , feeling tense ) , cognition ( e.g. , difficulty concentrating ) , and fatigue ( e.g. , exhaustion , feeling sleepy ) demonstrated significant daily and diurnal variation , with higher overall symptom scores noted on hemodialysis days and later in the day .
RESULTS	In factor analysis , 4 factors explained the majority of the observed variance for DISS symptoms .
RESULTS	Fatigue , sleepiness , and exhaustion loaded onto the same factor and were highly intercorrelated .
RESULTS	In LMM , mean composite fatigue-sleepiness-exhaustion scores were associated with dialysis day ( coefficient and 95 % confidence interval [ CI ] 0.21 [ 0.02 - 0.39 ] ) and time of day ( coefficient and 95 % CI 0.33 [ 0.25 - 0.41 ] .
RESULTS	Observed associations were minimally affected by adjustment for demographics and common confounders .
CONCLUSIONS	Maintenance HD patients experience fatigue-sleepiness-exhaustion symptoms that demonstrate significant daily and diurnal variation .
CONCLUSIONS	The variability in symptoms may contribute to poor symptom awareness by providers and greater misclassification bias of fatigue related symptoms in clinical studies .

###24999075
OBJECTIVE	Endometrial adenocarcinoma ( EC ) is the most common gynaecologic cancer .
OBJECTIVE	Up to 90 % of EC patients are obese which poses a health threat to patients post-treatment .
OBJECTIVE	Standard treatment for EC includes hysterectomy , although this has significant side effects for obese women at high risk of surgical complications and for women of childbearing age .
OBJECTIVE	This trial investigates the effectiveness of non-surgical or conservative treatment options for obese women with early stage EC .
OBJECTIVE	The primary aim is to determine the efficacy of : levonorgestrel intrauterine device ( LNG-IUD ) ; with or without metformin ( an antidiabetic drug ) ; and with or without a weight loss intervention to achieve a pathological complete response ( pCR ) in EC at six months from study treatment initiation .
OBJECTIVE	The secondary aim is to enhance understanding of the molecular processes and to predict a treatment response by investigating EC biomarkers .
METHODS	An open label , three-armed , randomised , phase-II , multi-centre trial of LNG-IUD metformin weight loss intervention .
METHODS	165 participants from 28 centres are randomly assigned in a 3:3:5 ratio to the treatment arms .
METHODS	Clinical , quality of life and health behavioural data will be collected at baseline , six weeks , three and six months .
METHODS	EC biomarkers will be assessed at baseline , three and six months .
CONCLUSIONS	There is limited prospective evidence for conservative treatment for EC .
CONCLUSIONS	Trial results could benefit patients and reduce health system costs through a reduction in hospitalisations and through lower incidence of adverse events currently observed with standard treatment .

###25380077
OBJECTIVE	To compare the cost-effectiveness of three types of follow-up for outpatients with stable low-activity rheumatoid arthritis ( RA ) .
METHODS	In total , 287 patients were randomized to either planned rheumatologist consultations , shared care without planned consultations , or planned nurse consultations .
METHODS	Effectiveness measures included disease activity ( Disease Activity Score based on 28 joint counts and C-reactive protein , DAS28-CRP ) , functional status ( Health Assessment Questionnaire , HAQ ) , and health-related quality of life ( EuroQol EQ-5D ) .
METHODS	Cost measures included activities in outpatient clinics and general practice , prescription and non-prescription medicine , dietary supplements , other health-care resources , and complementary and alternative care .
METHODS	Measures of effectiveness and costs were collected by self-reported questionnaires at inclusion and after 12 and 24 months .
METHODS	Incremental cost-effectiveness rates ( ICERs ) were estimated in comparison with rheumatologist consultations .
RESULTS	Changes in disease activity , functional status , and health-related quality of life were not statistically significantly different for the three groups , although the mean scores were better for the shared care and nurse care groups compared with the rheumatologist group .
RESULTS	Shared care and nurse care were non-significantly less costly than rheumatologist care .
RESULTS	As both shared care and nurse care were associated with slightly better EQ-5D improvements and lower costs , they dominated rheumatologist care .
RESULTS	At EUR 10,000 per quality-adjusted life year ( QALY ) threshold , shared care and nurse care were cost-effective with more than 90 % probability .
RESULTS	Nurse care was cost-effective in comparison with shared care with 75 % probability .
CONCLUSIONS	Shared care and nurse care seem to cost less but provide broadly similar health outcomes compared with rheumatologist outpatient care .
CONCLUSIONS	However , it is still uncertain whether nurse care and shared care are cost-effective in comparison with rheumatologist outpatient care .

###25563714
BACKGROUND	Methotrexate is a commonly used anti-inflammatory and immunosuppressive drug .
BACKGROUND	There is growing evidence that inflammatory processes are involved in the pathogenesis of schizophrenia .
BACKGROUND	In our recent randomised double-blind placebo-controlled clinical trial in Pakistan and Brazil , the addition of minocycline ( antibiotic and anti-inflammatory drug ) for 1year to treatment as usual reduced negative symptoms and improved some cognitive measures .
BACKGROUND	A meta-analysis of cytokine changes in the peripheral blood has identified IL-2 , IFN-gamma , TNF-alpha and soluble IL-2 receptor as trait markers of schizophrenia because their levels were elevated during acute exacerbations and reduced in remission .
BACKGROUND	This suggests immune activation and an inflammatory syndrome in schizophrenia .
BACKGROUND	Based on the evidence of the strong anti-inflammatory properties of methotrexate , we propose that low-dose methotrexate may be an effective therapy in early schizophrenia .
METHODS	This is a double-blind placebo-controlled study of methotrexate added to treatment as usual for patients suffering from schizophrenia , schizoaffective disorder , psychosis not otherwise specified or schizophreniform disorder .
METHODS	This will be with 72 patients , 36 in each arm over 3months .
METHODS	There will be screening , randomisation and follow-up visits .
METHODS	Full clinical assessments will be carried out at baseline , 2 , 4 , 8 and 12weeks .
METHODS	Social and cognitive assessments will be carried out at baseline and 12weeks .
METHODS	Methotrexate will be given at a dose of 10 mgs orally once a week for a 3-month period .
CONCLUSIONS	Evidence suggests inflammatory processes are involved in the pathogenesis of schizophrenia and anti-inflammatory treatments have shown to have some beneficial effects .
CONCLUSIONS	Methotrexate is a known immunosuppressant and anti-inflammatory drug .
CONCLUSIONS	The aim of this study is to establish the degree of improvement in positive and negative symptoms , as well as cognitive functioning with the addition of methotrexate to treatment as usual.ClinicalTrials.gov identifier : NCT02074319 ( 24 February 2014 ) .

###24651208
BACKGROUND	The role of bony pelvic anomalies in bladder exstrophy is long established and has generated many papers addressing walking problems .
BACKGROUND	Biomechanical studies and kinematic gait analysis were performed on very young children .
OBJECTIVE	A direct kinetic gait evaluation has never been performed , nor has the effect of pelvis dimorphism on the upper body been studied .
METHODS	Controlled experimental study .
METHODS	Outpatients were studied at the time of periodic follow up .
METHODS	Nineteen patients with bladder exstrophy , age 148 years , and twenty-five healthy control participants , age 158 years , were enrolled in the present gait analysis study .
METHODS	Clinical evaluation and standard gait analysis were performed .
RESULTS	Gait analysis deviations between exstrophy patients and controls and between patients that received pelvic osteotomy ( OT -- 6 patients ) and those that did not ( no-OT -- 13 patients ) were analyzed .
RESULTS	Bladder exstrophy significantly affects kinematics and kinetics of trunk , spine , pelvis , knee and foot ; in particular : in OT , trunk retroversion , pelvic retroversion and rotation , hip adduction angle and moment , knee flexion and its maximum power during loading response increased , whereas in no-OT , spine angle , pelvic posterior tilt , hip extension , and the external rotation of the foot progression angle increased .
RESULTS	All the kinetics parameters analyzed in the study showed lower values in the patient group than in controls .
CONCLUSIONS	Walking in patients with bladder exstrophy is accomplished by retroversion of the pelvis and deviations mainly in the spine angle in no-OT and in knee flexion in OT .
CONCLUSIONS	Gait analysis was shown to be an effective tool for the detection of walking deviations that should be identified early , prompting rehabilitative treatment in order to prevent spine and knee diseases .

###24332365
BACKGROUND	Maladaptive behaviors may be more fully understood and efficiently prevented by ambulatory tools that assess people 's ongoing experience in the context of their environment .
METHODS	To demonstrate new field-deployable methods for assessing mood and behavior as a function of neighborhood surroundings ( geographical momentary assessment ; GMA ) , we collected time-stamped GPS data and ecological momentary assessment ( EMA ) ratings of mood , stress , and drug craving over 16 weeks at randomly prompted times during the waking hours of opioid-dependent polydrug users receiving methadone maintenance .
METHODS	Locations of EMA entries and participants ' travel tracks calculated for the 12 before each EMA entry were mapped .
METHODS	Associations between subjective ratings and objective environmental ratings were evaluated at the whole neighborhood and 12-h track levels .
RESULTS	Participants ( N = 27 ) were compliant with GMA data collection ; 3711 randomly prompted EMA entries were matched to specific locations .
RESULTS	At the neighborhood level , physical disorder was negatively correlated with negative mood , stress , and heroin and cocaine craving ( ps < .0001 -.0335 ) ; drug activity was negatively correlated with stress , heroin and cocaine craving ( ps .0009 -.0134 ) .
RESULTS	Similar relationships were found for the environments around respondents ' tracks in the 12h preceding EMA entries .
CONCLUSIONS	The results support the feasibility of GMA .
CONCLUSIONS	The relationships between neighborhood characteristics and participants ' reports were counterintuitive and counter-hypothesized , and challenge some assumptions about how ostensibly stressful environments are associated with lived experience and how such environments ultimately impair health .
CONCLUSIONS	GMA methodology may have applications for development of individual - or neighborhood-level interventions .

###25218370
OBJECTIVE	In single-incision laparoscopic surgery ( SILS ) , operating through 1 incision presents ergonomic challenges .
OBJECTIVE	No consensus exists on whether articulating instruments ( ARTs ) may help .
OBJECTIVE	This study evaluated their effect on simulated SILS , hypothesizing that they would affect performance and workload .
METHODS	Surgeons were randomized to 2 straight instruments ( STRs ) , 1 ART and 1 STR , or 2 ARTs .
METHODS	After baseline testing , 25 repetitions of the Fundamentals of Laparoscopic Surgery ( FLS ) peg-transfer ( PEG ) task and 5 repetitions of the short-hand for the FLS pattern-cutting task ( CIRCLE ) were performed .
METHODS	Primary outcomes were maximum FLS PEG scores , CIRCLE times and errors , and Imperial College Surgical Assessment Device hand motion analysis .
METHODS	National Aeronautics and Space Administration ( NASA ) Raw Task Load Index ( RTLX ) questionnaires evaluated a secondary outcome -- workload .
METHODS	The trial took place in a simulated operating theater within the Academic Surgical Unit at St Mary 's Hospital , London , UK .
METHODS	Eligible surgeons had completed at least 5 laparoscopic cases as a primary operator .
METHODS	Surgeons were stratified by laparoscopic experience into intermediate ( less than 25 previous procedures as primary operator ) or advanced ( 25 procedures or more ) .
METHODS	A total of 21 surgeons were recruited and randomized ; 7 of them to each instrument combination group .
METHODS	All surgeons completed PEG , and 5 from each group completed CIRCLE .
RESULTS	Groups ' baseline PEG scores were similar ( p = 0.625 ) .
RESULTS	STR-ART achieved higher maximum PEG scores than STR or ART did ( median = 236 vs 198 vs 193 , respectively , p = 0.002 ) .
RESULTS	Fastest CIRCLE times were similar ( median = 190s vs 130s vs 186s , p = 0.129 ) as were minimum errors ( median = 1 vs 2 vs 3 , p = 0.101 ) .
RESULTS	For PEG , Imperial College Surgical Assessment Device demonstrated similar total path lengths ( median = 12.3 m vs 12.3 m vs 16.0 m , p = 0.545 ) and total numbers of movements ( median = 89.6 vs 86.4 vs 171 , p = 0.080 ) .
RESULTS	Groups ' NASA Raw Task Load Index scores were similar ( p = 0.708 ) .
CONCLUSIONS	Combining 1 STR and 1 ART improved SILS performance in the PEG task .
CONCLUSIONS	Therefore , this may be the optimum instrument configuration for use within some clinical SILS applications .

###25270176
OBJECTIVE	We evaluated the effectiveness of a continuing medical education program , Physician Asthma Care Education , in improving pediatricians ' asthma therapeutic and communication skills and patients ' health care utilization for asthma .
METHODS	We conducted a randomized trial in 10 regions in the United States .
METHODS	Primary care providers were recruited and randomly assigned by site to receive the program provided by local faculty .
METHODS	The program included 2 interactive seminar sessions ( 2.5 hours each ) that reviewed national asthma guidelines , communication skills , and key educational messages .
METHODS	Format included short lectures , case discussions , and a video modeling communication techniques .
METHODS	We collected information on parent perceptions of physicians ' communication , the child 's asthma symptoms , and patients ' asthma health care utilization .
METHODS	We used multivariate regression models to determine differences between control and intervention groups .
RESULTS	A total of 101 primary care providers and a random sample of 870 of their asthma patients participated .
RESULTS	After 1 year , we completed follow-up telephone interviews with the parents of 731 of the 870 patients .
RESULTS	Compared to control subjects , parents reported that physicians in the intervention group were more likely to inquire about patients ' concerns about asthma , encourage patients to be physically active , and set goals for successful treatment .
RESULTS	Patients of physicians that attended the program had a greater decrease in days limited by asthma symptoms ( 8.5 vs 15.6 days ) , as well as decreased emergency department asthma visits ( 0.30 vs 0.55 visits per year ) .
CONCLUSIONS	The Physician Asthma Care Education program was used in a range of locations and was effective in improving parent-reported provider communication skills , the number of days affected by asthma symptoms , and asthma health care use .
CONCLUSIONS	Patients with more frequent asthma symptoms and higher health care utilization at baseline were more likely to benefit from their physician 's participation in the program .

###25127725
BACKGROUND	There are few rigorous studies to confirm or refute the commonly cited concern that control of blood pressure to lower thresholds may result in an increased risk of falls and fractures .
OBJECTIVE	To compare falls and fractures in participants with type 2 diabetes in the intensive ( targeting a systolic blood pressure of < 120 mmHg ) and standard ( targeting a systolic blood pressure of < 140 mmHg ) blood pressure control arms of the Action to Control Cardiovascular Risk in Diabetes ( ACCORD ) randomized trial ( N = 4,733 ) .
METHODS	A subset of 3,099 participants self-reported annually on the occurrence of falls and non-spine fractures .
METHODS	Fractures were centrally adjudicated .
METHODS	The incidence of falls in the two treatment groups was compared using a random-effects negative binomial model , and fracture risk was compared using Cox proportional hazards models .
RESULTS	At enrollment in both groups , the mean age was 62 years , 44 % were women , 25 % were Black , and mean blood pressure was 138/75 mmHg .
RESULTS	During follow-up , all classes of medications , particularly thiazide diuretics , were more commonly prescribed in the intensive group .
RESULTS	After 1 year of follow-up , the mean systolic blood pressure was 13315 mmHg in the standard group and 11914 mmHg in the intensive group .
RESULTS	The adjusted rate of falls did not differ in the intensive and standard groups ( 62.2 / 100 person-years vs. 74.1 / 100 person-years , RR = 0.84 , 95 % CI 0.54-1 .29 , p = 0.43 ) .
RESULTS	The risk of non-spine fractures was nonsignificantly lower in the intensive than in the standard blood pressure group ( HR 0.79 , 95 % CI 0.62-1 .01 , p = 0.06 ) .
CONCLUSIONS	We conclude that intensive antihypertensive treatment that lowered mean systolic blood pressure to below 120 mmHg was not associated with an increased risk of falls or non-spine fractures in patients age 40 to 79 years with type 2 diabetes .

###26010803
OBJECTIVE	Thromboembolism is the most common complication in coiling for an unruptured aneurysm and is frequent in patients with high on-treatment platelet reactivity ( HTPR ) who are prescribed a standard antiplatelet preparation for its prevention .
OBJECTIVE	To evaluate the effect of a modified antiplatelet preparation compared with a standard preparation in patients with HTPR undergoing coiling .
METHODS	A prospective randomized open-label active-control trial with blinded outcome assessment at the Seoul National University Bundang Hospital from May 27 , 2013 , to April 7 , 2014 .
METHODS	Patients with HTPR were randomly assigned ( 1 to 1 ) to the standard or modified preparation group .
METHODS	Patients without HTPR were assigned to the non-HTPR group .
METHODS	A total of 228 patients undergoing coiling for unruptured aneurysms were enrolled and allocated to the study , 126 in the HTPR group ( 63 to the standard preparation group and 63 to the modified preparation group ) and 102 to the non-HTPR group .
METHODS	Intent-to-treat analysis was performed .
METHODS	The modified preparation ( HTPR to aspirin , 300 mg of aspirin and 75 mg of clopidogrel bisulfate ; and HTPR to clopidogrel , 200 mg of cilostazol added to the standard regimen ) was performed before coiling in the modified preparation group .
METHODS	Standard preparation ( 100 mg of aspirin and 75 mg of clopidogrel ) was maintained in the standard preparation and non-HTPR groups .
METHODS	The primary outcome was a thromboembolic event defined as thromboembolism during coiling and a transient ischemic attack or ischemic stroke within 7 days after coiling .
METHODS	The principal secondary outcome was a bleeding complication according to Thrombolysis in Myocardial Infarction bleeding criteria within 30 days after coil embolization .
RESULTS	The thromboembolic event rate was low in the modified preparation group ( 1 of 63 [ 1.6 % ] ) compared with the standard preparation group ( 7 of 63 [ 11.1 % ] ; adjusted risk difference , -11.7 % [ 95 % CI , -21.3 % to -2.0 % ] ; P = .02 ) , which had a higher thromboembolic risk than the non-HTPR group ( 1 of 102 [ 1.0 % ] ; adjusted risk difference , 8.6 % [ 95 % CI , 1.0 % to 16.3 % ] ; P = .03 ) .
RESULTS	All bleeding complications were of minimal grade according to Thrombolysis in Myocardial Infarction bleeding criteria .
RESULTS	The bleeding rate was not different between the modified ( 6 of 63 [ 9.5 % ] ) and standard ( 4 of 63 [ 6.3 % ] ) preparation groups ( adjusted risk difference , 5.6 % [ 95 % CI , -4.2 % to 15.4 % ] ; P = .26 ) .
CONCLUSIONS	Modified antiplatelet preparation for patients with HTPR compared with standard antiplatelet preparation reduced the thromboembolic event rate in coiling for an unruptured aneurysm without increasing bleeding .
BACKGROUND	Clinical Research Information Service Identifier : KCT0000804 .

###25711974
BACKGROUND	Minority patients with breast cancer are at risk for undertreatment of cancer-related pain .
BACKGROUND	The authors evaluated the feasibility and efficacy of an automated pain intervention for improving pain and symptom management of underserved African American and Latina women with breast cancer .
METHODS	Sixty low-income African American and Latina women with breast cancer and cancer-related pain were enrolled in a pilot study of an automated , telephone-based , interactive voice response ( IVR ) intervention .
METHODS	Women in the intervention group were called twice weekly by the IVR system and asked to rate the intensity of their pain and other symptoms .
METHODS	The patients ' oncologists received e-mail alerts if the reported symptoms were moderate to severe .
METHODS	The patients also reported barriers to pain management and received education regarding any reported obstacles .
RESULTS	The proportion of women in both groups reporting moderate to severe pain decreased during the study , but the decrease was significantly greater for the intervention group .
RESULTS	The IVR intervention also was associated with improvements in other cancer-related symptoms , including sleep disturbance and drowsiness .
RESULTS	Although patient adherence to the IVR call schedule was good , the oncologists who were treating the patients rated the intervention as only somewhat useful for improving symptom management .
CONCLUSIONS	The IVR intervention reduced pain and symptom severity for underserved minority women with breast cancer .
CONCLUSIONS	Additional research on technological approaches to symptom management is needed .

###24244395
OBJECTIVE	To evaluate the effect of an improved salt-restriction spoon on the attitude of salt-restriction , the using rate of salt-restriction-spoon , the actual salt intake , and 24-hour urinary sodium excretion ( 24HUNa ) .
METHODS	A community intervention study .
METHODS	Two villages in Beijing .
METHODS	403 local adult residents being responsible for home cooking .
METHODS	Participants were randomly assigned to the intervention group or the control group .
METHODS	Those in the intervention group were provided with an improved salt-restriction-spoon and health education , and were informed of their actual salt intake and 24HUNa .
METHODS	Not any intervention was given to those in the control group .
METHODS	The scores on the variables of Health Belief Model , the using rate of salt-restriction-spoon , the actual salt intake , and 24HUNa .
METHODS	Covariance analyses , Chi-square tests , Student 's t tests , and repeated measures analyses of variance .
RESULTS	After 6 months of intervention , the intervention group felt significantly less objective barriers , and got access to significantly more cues to action as compared to the control group .
RESULTS	The using rate and the correctly using rate of salt-restriction-spoon were significantly higher in the intervention group .
RESULTS	The daily salt intake decreased by 1.42 g in the intervention group and by 0.28 g in the control group , and repeated measures analysis of variance showed significant change over time ( F = 7.044 , P < 0.001 ) and significant difference between groups by time ( F = 2.589 , P = 0.041 ) .
RESULTS	The 24HUNa decreased by 34.84 mmol in the intervention group and by 33.65 mmol in the control group , and repeated measures analysis of variance showed significant change over time ( F = 14.648 , P < 0.001 ) without significant difference between groups by time ( F = 0.222 , P = 0.870 ) .
CONCLUSIONS	The intervention effect was acceptable , therefore , the improved salt-restriction-spoon and corresponding health education could be considered as an alternative for salt reduction strategy in China and other countries where salt intake comes mainly from home cooking .

###24554030
OBJECTIVE	Revisional laparoscopic surgery after Roux-en-Y gastric bypass ( RYGB ) has been linked to substantial complications and morbidity .
OBJECTIVE	To investigate the safety and effectiveness of endoscopic gastric plication with the StomaphyX device vs a sham procedure for revisional surgery in RYGB patients to reduce regained weight .
METHODS	A prospective , single-center , randomized , single-blinded study from July 2009 through February 2011 , evaluating revisional surgery using StomaphyX was conducted in patients with initial weight loss after RYGB performed at least 2 years earlier .
METHODS	We planned for 120 patients to be randomized 2:1 to multiple full-thickness plications within the gastric pouch and stoma using the StomaphyX device with SerosFuse fasteners or a sham endoscopic procedure and followed up for 1 year .
METHODS	The primary efficacy end point was reduction in pre-RYGB excess weight by 15 % or more excess body mass index ( BMI ) ( calculated as weight in kilograms divided by height in meters squared ) loss and BMI less than 35 at 12 months after the procedure .
METHODS	Adverse events were recorded .
RESULTS	Enrollment was closed prematurely because preliminary results indicated failure to achieve the primary efficacy end point in at least 50 % of StomaphyX-treated patients .
RESULTS	One-year follow-up was completed by 45 patients treated with StomaphyX and 29 patients in the sham treatment group .
RESULTS	Primary efficacy outcome was achieved by 22.2 % ( 10 ) with StomaphyX vs 3.4 % ( 1 ) with the sham procedure ( P < .01 ) .
RESULTS	Patients undergoing StomaphyX treatment experienced significantly greater reduction in weight and BMI at 3 , 6 , and 12 months ( P. 05 ) .
RESULTS	There was one causally related adverse event with StomaphyX , that required laparoscopic exploration and repair .
CONCLUSIONS	StomaphyX treatment failed to achieve the primary efficacy target and resulted in early termination of the study .
BACKGROUND	clinicaltrials.gov Identifier : NCT00939055 .

###24940704
BACKGROUND	Carpal tunnel syndrome is traditionally treated with open release through a long palmar incision , which leaves some patients with pillar pain and scar tenderness .
BACKGROUND	The Knifelight ( Stryker , Kalamazoo , MI ) is an exciting new instrument that allows minimally invasive release of the transcarpal ligament without subjecting the patient to the traditional problematic open palmar incision .
BACKGROUND	However , no long-term data has been published in the literature so far .
METHODS	A modified QuickDASH score questionnaire was used to assess long-term results and patient satisfaction 10 years following our department 's original randomized control trial comparing open carpal tunnel release ( 43 patients ) to carpal tunnel release using the Knifelight method ( 39 patients ) .
RESULTS	The mean modified QuickDASH score was 33.71 ( SD 23.27 ) for the open group and 13.22 ( SD 13.62 ) for the Knifelight group ( P-value = 0.0024 ) .
RESULTS	Patients from the open group complained of pillar pain ( 30 % ) , scar tenderness ( 25 % ) and recurrence of carpal tunnel symptoms ( 18 % ) .
RESULTS	Three patients had symptoms so severe that they could not perform their jobs .
RESULTS	In the Knifelight group there were no reports of any pain , recurrence or scar-related problems and a high level of general satisfaction was observed with this group of patients .
CONCLUSIONS	Our study results show that the minimally invasive Knifelight carpal tunnel release was associated with better clinical outcomes , less complications and overall better quality of life when compared to the conventional open carpal tunnel release .

###24970869
OBJECTIVE	Calcitriol is used to treat secondary hyperparathyroidism in patients with CKD .
OBJECTIVE	Paricalcitol is less calcemic and phosphatemic in preclinical studies and in some trials in dialysis patients , but head-to-head comparisons in nondialysis patients are lacking .
OBJECTIVE	A large meta-analysis of trials concluded that these agents did not consistently reduce parathyroid hormone ( PTH ) and increased the risk of hypercalcemia and hyperphosphatemia .
OBJECTIVE	Therefore , the objective of this multicenter trial was to compare the rate of hypercalcemia between calcitriol and paricalcitol , while suppressing PTH 40 % -60 % .
METHODS	Patients with stages 3-4 CKD ( n = 110 ) with a PTH level > 120 pg/ml were recruited and randomized to 0.25 g/d of calcitriol or 1 g/d of paricalcitol between April 2009 and July 2011 .
METHODS	Subsequent dose adjustments were by protocol to achieve 40 % -60 % PTH suppression below baseline .
METHODS	The primary endpoint was the rate of confirmed hypercalcemia of > 10.5 mg/dl between groups .
RESULTS	Forty-five patients in each group completed the 24 weeks of treatment .
RESULTS	Both agents suppressed PTH effectively ( -52 % with paricalcitol and -46 % with calcitriol ; P = 0.17 ) , although the paricalcitol group reached a 40 % reduction in PTH sooner at a median 8 weeks ( interquartile range [ IQR ] , 4 , 12 ) versus 12 weeks ( IQR , 8 , 18 ; P = 0.02 ) and had a lower pill burden of 240 ( IQR , 180 , 298 ) versus 292 ( IQR , 231 , 405 ; P = 0.01 ) .
RESULTS	Confirmed hypercalcemia was very low in both groups ( three with paricalcitol and one with calcitriol ) and was not significantly different ( P = 0.36 ) .
RESULTS	Both groups had small increases in calcium and phosphorus levels ( 0.3-0 .4 mg/dl in each electrolyte ) and significant decreases in alkaline phosphatase , a marker of high bone turnover , with no significant differences between groups .
CONCLUSIONS	These results show that both calcitriol and paricalcitol achieved sustained PTH and alkaline phosphatase suppression in stages 3-4 CKD , with small effects on serum calcium and phosphorus and a low incidence of hypercalcemia .

###25648342
BACKGROUND	Both testosterone therapy and chronic treatment with phosphodiesterase type 5 inhibitors ( PDE5Is ) have positive effects on the histology of penile corpora and erectile function .
BACKGROUND	However , few clinical studies have evaluated the efficacy of combination therapy with both testosterone replacement and chronic PDE5Is .
OBJECTIVE	This study was designed to evaluate the efficacy and safety of combination treatment with long-acting injectable testosterone undecanoate ( TU ) and a once-daily tadalafil 5mg for erectile dysfunction with testosterone deficiency syndrome .
METHODS	Sixty patients were consecutively enrolled and followed for 36 weeks .
METHODS	Thirty patients were randomly assigned to group I and received 1,000 mg of parenteral TU on day 1 , followed by additional injections at weeks 6 and 18 with on-demand tadalafil 10-20mg during the 30 weeks of treatment .
METHODS	The remaining 30 patients received the same dose and schedule of TU as group I , and were prescribed once-daily tadalafil 5mg during 30 weeks .
METHODS	Serological tests were performed , and the International Index of Erectile Function ( IIEF ) , Aging Males ' Symptoms ( AMS ) questionnaires , and Global Assessment Question ( GAQ ) were administered to the patients .
RESULTS	Total IIEF and AMS scores were significantly improved during the 30 weeks of treatment in both groups .
RESULTS	When IIEF scores were compared between the two groups , group II showed better symptom scores than group I at weeks 6 and 30 .
RESULTS	A similar pattern was observed when comparing AMS scores between the groups .
RESULTS	At week 36 , changes in IIEF and AMS scores that indicated worsened symptoms compared with week 30 were observed in both groups ; group II showed better symptom scores than group I. On the GAQ , the ratio of patients reporting improvement in erectile function was significantly higher in group II than group I.
CONCLUSIONS	The combination of long-acting injectable TU and once-daily tadalafil 5mg produced a significant improvement in erectile function .
CONCLUSIONS	Moreover , the improvement in erectile function was well maintained , even after the cessation of treatment .

###24238032
OBJECTIVE	To determine the effects of pretreatment with either promethazine or dexamethasone on mivacurium-induced histamine release in children .
METHODS	Eighty ASA I-II children ( 4-10years of age ) scheduled for tonsillectomy and/or adenoidectomy were randomly divided into 4 groups ( n = 20 per group ) designated as either the rocuronium , mivacurium , dexamethasone ( DXM ) , or promethazine group .
METHODS	Children in the DXM and promethazine groups were treated separately with intramuscular DXM 0.2 mgkg ( -1 ) or promethazine 0.5 mgkg ( -1 ) injections 60min before operation .
METHODS	Radial artery blood samples were collected to quantify plasma histamine concentrations 1min before and 1 , 3 , and 5min after administration of the relaxant .
METHODS	Mean arterial pressure ( MAP ) , heart rate ( HR ) , and skin flushing were recorded at the same time .
RESULTS	No significant decreases in plasma histamine concentrations were observed between groups ; however , more stable MAP and HR and less skin flushing were observed in DXM group participants compared with individuals in the mivacurium group ( P < 0.05 ) .
RESULTS	By contrast , children in the promethazine group had significantly decreased plasma histamine concentrations and stable MAP and HR ( without a significant increase in HR ) compared with patients in mivacurium group .
RESULTS	In addition , skin flushing was significantly decreased compared with that observed in the rocuronium group ( P < 0.05 ) .
CONCLUSIONS	Pretreatment with promethazine significantly decreased mivacurium-induced histamine release in children and provided stable hemodynamics during administration of anesthesia .

###24927164
OBJECTIVE	Improved health outcomes can result in economic savings for hospitals and payers .
OBJECTIVE	While effectiveness of topical hemostatic agents in cardiac surgery has been demonstrated , evaluations of their economic benefit are limited .
OBJECTIVE	This study quantifies the cost consequences to hospitals , based on clinical outcomes , from using a flowable hemostatic matrix vs non-flowable topical hemostatic agents in cardiac surgery .
METHODS	Applying clinical outcomes from a prospective randomized clinical trial , a cost consequence framework was utilized to model the economic impact of comparator groups .
METHODS	From that study , clinical outcomes were obtained and analyzed for a flowable hemostatic matrix ( FLOSEAL , Baxter Healthcare Corporation ) vs non-flowable topical hemostats ( SURGICEL Nu-Knit , Ethicon-Johnson & Johnson ; GELFOAM , Pfizer ) .
METHODS	Costing analyses focused on the following outcomes : complications , blood transfusions , surgical revisions , and operating room ( OR ) time .
METHODS	Cardiac surgery costs were analyzed and expressed in 2012 US dollars based on available literature searches and US data .
METHODS	Comparator group variability in cost consequences ( i.e. , cost savings ) was calculated based on annualized impact and scenario testing .
RESULTS	RESULTS suggest that if a flowable hemostatic matrix ( rather than a non-flowable hemostat ) was utilized exclusively in 600 mixed cardiac surgeries annually , a hospital could improve patient outcomes by a reduction of 33 major complications , 76 minor complications , 54 surgical revisions , 194 transfusions , and 242 h of OR time .
RESULTS	These outcomes correspond to a net annualized cost consequence savings of $ 5.38 million , with complication avoidance as the largest contributor .
CONCLUSIONS	This cost consequence framework and supportive modeling was used to evaluate the hospital economic impact of outcomes resulting from the usage of various hemostatic agents .
CONCLUSIONS	These analyses support that cost savings can be achieved from routine use of a flowable hemostatic matrix , rather than a non-flowable topical hemostat , in cardiac surgery .

###24792991
BACKGROUND	This report presents data from one of the first trials of apomorphine rescue treatment for advanced Parkinson 's disease ( PD ) conducted in Japan .
BACKGROUND	This 3 month trial aimed to evaluate the sustainability of efficacy of intermittent apomorphine rescue treatment .
METHODS	A phase III , double-blind , placebo-controlled trial was conducted in PD patients ( n = 31 ) with motor fluctuations in spite of individually titrated treatment with levodopa and other anti PD .
METHODS	Intermittent treatment was titrated to the maintenance dose with a subsequent unblind 12-week outpatient phase .
METHODS	At the week-12 visit , response to apomorphine or placebo was assessed as primary efficacy endpoint using the Unified Parkinson 's Disease Rating Scale ( UPDRS ) part III ( Motor Examination ) under double-blind crossover conditions .
RESULTS	In the crossover phase ( n = 28 ) , least squares mean changes in the UPDRS part III score from pre-dose were -24.5 points with apomorphine and -2.3 points with placebo , showing that apomorphine , compared with placebo , provided a significantly greater improvement in the UPDRS part III score change ( difference between treatments : -22.1 [ 95 % confidence interval , -27.8 , -16.4 ] ; P < 0.001 ) .
RESULTS	The most frequently reported adverse events during the study were increased eosinophil count ( 8 patients ) , nausea ( 7 ) , somnolence ( 6 ) , dyskinesia ( 5 ) , yawning ( 5 ) , and decreased blood pressure ( 3 ) .
CONCLUSIONS	Our results indicate that a 3-month use of intermittent apomorphine is an effective rescue therapy for `` off '' episodes in advanced PD patients .

###24930949
OBJECTIVE	To assess face , content and construct validity , and feasibility and acceptability of the GreenLight Simulator as a training tool for photoselective vaporisation of the prostate ( PVP ) , and to establish learning curves and develop an evidence-based training curriculum .
METHODS	This prospective , observational and comparative study , recruited novice ( 25 participants ) , intermediate ( 14 ) and expert-level urologists ( seven ) from the UK and Europe at the 28th European Association of Urological Surgeons Annual Meeting 2013 .
METHODS	A group of novices ( 12 participants ) performed 10 sessions of subtask training modules followed by a long operative case , whereas a second group ( 13 ) performed five sessions of a given case module .
METHODS	Intermediate and expert groups performed all training modules once , followed by one operative case .
METHODS	The outcome measures for learning curves and construct validity were time to task , coagulation time , vaporisation time , average sweep speed , average laser distance , blood loss , operative errors , and instrument cost .
METHODS	Face and content validity , feasibility and acceptability were addressed through a quantitative survey .
RESULTS	Construct validity was demonstrated in two of five training modules ( P = 0.038 ; P = 0.018 ) and in a considerable number of case metrics ( P = 0.034 ) .
RESULTS	Learning curves were seen in all five training modules ( P < 0.001 ) and significant reduction in case operative time ( P < 0.001 ) and error ( P = 0.017 ) were seen .
RESULTS	An evidence-based training curriculum , to help trainees acquire transferable skills , was produced using the results .
CONCLUSIONS	This study has shown the GreenLight Simulator to be a valid and useful training tool for PVP .
CONCLUSIONS	It is hoped that by using the training curriculum for the GreenLight Simulator , novice trainees can acquire skills and knowledge to a predetermined level of proficiency .

###24334198
BACKGROUND	Incidence of sexually transmitted infections ( STIs ) among young people in the United Kingdom is increasing .
BACKGROUND	The Internet can be a suitable medium for delivery of sexual health information and sexual health promotion , given its high usage among young people , its potential for creating a sense of anonymity , and ease of access .
BACKGROUND	Online randomized controlled trials ( RCTs ) are increasingly being used to evaluate online interventions , but while there are many advantages to online methodologies , they can be associated with a number of problems , including poor engagement with online interventions , poor trial retention , and concerns about the validity of data collected through self-report online .
BACKGROUND	We conducted an online feasibility trial that tested the effects of the Sexunzipped website for sexual health compared to an information-only website .
BACKGROUND	This study reports on a qualitative evaluation of the trial procedures , describing participants ' experiences and views of the Sexunzipped online trial including methods of recruitment , incentives , methods of contact , and sexual health outcome measurement .
OBJECTIVE	Our goal was to determine participants ' views of the acceptability and validity of the online trial methodology used in the pilot RCT of the Sexunzipped intervention .
METHODS	We used three qualitative data sources to assess the acceptability and validity of the online pilot RCT methodology : ( 1 ) individual interviews with 22 participants from the pilot RCT , ( 2 ) 133 emails received by the trial coordinator from trial participants , and ( 3 ) 217 free-text comments from the baseline and follow-up questionnaires .
METHODS	Interviews were audio-recorded and transcribed verbatim .
METHODS	An iterative , thematic analysis of all three data sources was conducted to identify common themes related to the acceptability and feasibility of the online trial methodology .
RESULTS	Interview participants found the trial design , including online recruitment via Facebook , online registration , email communication with the researchers , and online completion of sexual health questionnaires to be highly acceptable and preferable to traditional methods .
RESULTS	Incentives might assist in recruiting those who would not otherwise participate .
RESULTS	Participants generally enjoyed taking part in sexual health research online and found the questionnaire itself thought-provoking .
RESULTS	Completing the sexual health questionnaires online encouraged honesty in responding that might not be achieved with other methods .
RESULTS	The majority of interview participants also thought that receiving and returning a urine sample for chlamydia testing via post was acceptable .
CONCLUSIONS	These findings provide strong support for the use of online research methods for sexual health research , emphasizing the importance of careful planning and execution of all trial procedures including recruitment , respondent validation , trial related communication , and methods to maximize follow-up .
CONCLUSIONS	Our findings suggest that sexual health outcome measurement might encourage reflection on current behavior , sometimes leading to behavior change .
BACKGROUND	International Standard Randomized Controlled Trial Number ( ISRCTN ) : 55651027 ; http://www.controlled-trials.com/isrctn/pf/55651027 ( Archived by WebCite at http://www.webcitation.org/6LbkxdPKf ) .

###24710760
OBJECTIVE	In addition to lowering hemoglobin A1C , colesevelam has been shown to improve the atherogenic lipoprotein profile of subjects with type 2 diabetes mellitus ( T2DM ) when used in combination with metformin and/or sulfonylureas .
OBJECTIVE	A recent study evaluated the effects of colesevelam as antidiabetes monotherapy in adults with T2DM who had inadequate glycemic control ( hemoglobin A1C 7.5 to 9.5 % ) with diet and exercise alone ; we report here the effects on lipoprotein particle subclasses .
METHODS	Subjects were randomized to receive oral colesevelam 3.75 g/day ( n = 176 ) or placebo ( n = 181 ) for 24weeks .
METHODS	Changes in lipoprotein particle subclasses were determined by nuclear magnetic resonance spectroscopy .
RESULTS	At Week 24 with last observation carried forward , colesevelam produced a reduction in total low-density lipoprotein ( LDL ) particle concentration ( baseline : 1,611 nmol/L ; least-squares [ LS ] mean treatment difference : -143 nmol/L , p < 0.0001 ) versus placebo ; reductions were also seen in large , small , and very small LDL particle concentrations ( all p < 0.05 ) .
RESULTS	There was also a reduction in total very low-density lipoprotein ( VLDL ) and chylomicron particle concentration ( baseline : 88nmol/L ; LS mean treatment difference : -1 nmol/L , p = 0.82 ) that resulted from a lowering in small VLDL particle concentration ( baseline : 45nmol/L ; LS mean treatment difference : -5 nmol/L , p = 0.03 ) .
RESULTS	In addition , with colesevelam there was an increase in total high-density lipoprotein ( HDL ) particle concentration versus placebo ( baseline : 31mol/L ; LS mean treatment difference : +0.6 mol/L , p = 0.20 ) , due to increases in the large ( baseline : 5mol/L ; LS mean treatment difference : +0.5 mol/L , p = 0.007 ) and medium ( baseline : 3mol/L ; LS mean treatment difference : +0.8 mol/L , p = 0.02 ) HDL subclasses .
CONCLUSIONS	Colesevelam monotherapy in subjects with T2DM resulted in generally favorable changes in certain lipoprotein subclass profiles compared with placebo .

###24798786
BACKGROUND	Amino-terminal B-type natriuretic peptide ( NT-proBNP ) may detect early cardiac dysfunction in adults with tetralogy of Fallot ( ToF ) late after corrective surgery .
BACKGROUND	We aimed to determine the value of NT-proBNP in adults with ToF and establish its relationship with echocardiography and exercise capacity .
RESULTS	NT-proBNP measurement , electrocardiography and detailed 2D-echocardiography were performed on the same day in 177 consecutive adults with ToF ( mean age 34.6 11.8 years , 58 % male , 89 % NYHA I , 29.3 8.5 years after surgical correction ) .
RESULTS	Thirty-eight percent of the patients also underwent a cardiopulmonary-exercise test .
RESULTS	Median NT-proBNP was 16 [ IQR 6.7-33 .6 ] pmol/L , and was elevated in 55 % .
RESULTS	NT-proBNP correlated with right ventricular ( RV ) dilatation ( r = 0.271 , p < 0.001 ) and RV systolic dysfunction ( r = -0.195 , p = 0.022 ) , but more strongly with LV systolic dysfunction ( r = -0.367 , p < 0.001 ) , which was present in 69 patients ( 39 % ) .
RESULTS	Moderate or severe pulmonary regurgitation was not associated with higher NT-proBNP .
RESULTS	Tricuspid and pulmonary regurgitation peak velocities correlated with NT-proBNP ( r = 0.305 , p < 0.001 and r = 0.186 , p = 0.045 , respectively ) .
RESULTS	LV twist was measured with speckle-tracking echocardiography in 71 patients .
RESULTS	An abnormal LV twist ( 20 patients , 28 % ) was associated with elevated NT-proBNP ( p = 0.030 ) .
RESULTS	No relationship between NT-proBNP and exercise capacity was found .
CONCLUSIONS	NT-proBNP levels are elevated in more than 50 % of adults with corrected ToF , while they are in stable clinical condition .
CONCLUSIONS	Higher NT-proBNP is most strongly associated with elevated pulmonary pressures , and with LV dysfunction rather than RV dysfunction .
CONCLUSIONS	NT-proBNP has the potential to become routine examination in patients with ToF to monitor ventricular function and may be used for timely detection of clinical deterioration .

###25321886
OBJECTIVE	Previous research has documented the feasibility of screening in emergency departments for adolescent suicide risk .
OBJECTIVE	This randomized trial examined the effectiveness of Teen Options for Change ( TOC ) , an intervention for adolescents seeking general medical emergency services who screen positive for suicide risk .
METHODS	Participants were 49 youths , ages 14 to 19 , seeking services for nonpsychiatric emergencies .
METHODS	They screened positive for suicide risk because of recent suicidal ideation , suicide attempt , or depression plus substance abuse .
METHODS	Youths were randomly assigned to the TOC intervention or to enhanced treatment as usual .
METHODS	Depression , hopelessness , and suicidal ideation were assessed at baseline and two months later .
RESULTS	Adolescents assigned to TOC showed greater reductions in depression than adolescents assigned to the comparison group ( Cohen 's d = 1.07 , a large effect size ) .
RESULTS	Hopelessness , suicidal ideation , and substance abuse outcomes trended positively ( nonsignificantly ) , with small to moderate effect sizes .
CONCLUSIONS	TOC may be a promising , brief intervention for adolescents seeking emergency services and at risk of suicide .

###25028357
OBJECTIVE	This study aimed to investigate whether targeted retinal photocoagulation ( TRP ) for nonperfused areas ( NPAs ) could have a preventive effect on the recurrence of diabetic macular edema ( DME ) after intravitreal injection of bevacizumab ( IVB ) .
METHODS	Eyes in the IVB group received 1.25 mg IVB , and eyes in the IVB+TRP group received 1.25 mg IVB combined with TRP of NPAs .
METHODS	Two weeks before IVB administration , grid/focal photocoagulation ( PC ) had been performed in both groups .
METHODS	After IVB treatment , the best corrected visual acuity ( BCVA ) and central retinal thickness ( CRT ) , determined by optical coherence tomography , were measured every month for 6 months .
RESULTS	Fifty-two patients with DME were enrolled and randomized to an IVB group ( n = 26 ) and an IVB+TRP group ( n = 26 ) .
RESULTS	After IVB , the CRT decreased temporally , and the CRT significantly increased at 2 months and thereafter in the IVB group but did not increase significantly in the IVB+TRP group .
RESULTS	Maximum increase in CRT after IVB was significantly correlated with the width of NPAs in the IVB group ( P = 0.0368 ) , but not in the IVB+TRP group .
RESULTS	Best corrected visual acuity in the IVB+TRP group was significantly better than that in the IVB group 5 and 6 months after treatment ( P < 0.05 ) .
CONCLUSIONS	Targeted retinal photocoagulation for NPAs was effective to maintain the reduced CRT after grid/focal PC and IVB for patients with DME .
CONCLUSIONS	These results suggest that retinal ischemia is associated with the pathogenesis of recurrence of DME after IVB .
CONCLUSIONS	( www.umin.ac.jp/ctr number , UMIN000007566 . )

###24330656
BACKGROUND	Smokers attend preferentially to cigarettes and other smoking-related cues in the environment , in what is known as an attentional bias .
BACKGROUND	There is evidence that attentional bias may contribute to craving and failure to stop smoking .
BACKGROUND	Attentional retraining procedures have been used in laboratory studies to train smokers to reduce attentional bias , although these procedures have not been applied in smoking cessation programmes .
BACKGROUND	This trial will examine the efficacy of multiple sessions of attentional retraining on attentional bias , craving , and abstinence in smokers attempting cessation .
METHODS	This is a double-blind randomised controlled trial .
METHODS	Adult smokers attending a 7-session weekly stop smoking clinic will be randomised to either a modified visual probe task with attentional retraining or placebo training .
METHODS	Training will start 1 week prior to quit day and be given weekly for 5 sessions .
METHODS	Both groups will receive 21 mg transdermal nicotine patches for 8-12 weeks and withdrawal-orientated behavioural support for 7 sessions .
METHODS	Primary outcome measures are the change in attentional bias reaction time and urge to smoke on the Mood and Physical Symptoms Scale at 4 weeks post-quit .
METHODS	Secondary outcome measures include differences in withdrawal , time to first lapse and prolonged abstinence at 4 weeks post-quit , which will be biochemically validated at each clinic visit .
METHODS	Follow-up will take place at 8 weeks , 3 months and 6 months post-quit .
CONCLUSIONS	This is the first randomised controlled trial of attentional retraining in smokers attempting cessation .
CONCLUSIONS	This trial could provide proof of principle for a treatment aimed at a fundamental cause of addiction .
BACKGROUND	Current Controlled Trials : ISRCTN54375405 .

###25277215
BACKGROUND	Laparoscopic surgery might be beneficial for the patient , but it imposes increased physical and mental strain on the surgeon .
BACKGROUND	Robot-assisted laparoscopic surgery addresses some of the laparoscopic drawbacks and may potentially reduce mental strain .
BACKGROUND	This could reduce the risk of surgeon 's fatigue , mishaps and strain-induced illnesses , which may eventually improve the safety of laparoscopic surgical procedures .
METHODS	To test this hypothesis , a randomized study was performed , comparing both heart rate and heart rate variability ( HRV ) of the surgeon as a measure of total and mental strain , respectively , during conventional and robot-assisted laparoscopic cholecystectomy .
RESULTS	Both heart rate and HRV ( the low-frequency band/high-frequency band ratio ) were significantly decreased when using robotic assistance .
CONCLUSIONS	These data suggest the use of the daVinci Surgical System leads to less physical and mental strain of the surgeon during surgery .
CONCLUSIONS	However , assessing mental strain by means of HRV is cumbersome since there is no clear cutoff point or scale for maximum tolerated strain levels and its related effects on surgeon 's health .

###24382064
BACKGROUND	Co-trimoxazole ( fixed-dose trimethoprim-sulfamethoxazole ) prophylaxis administered before antiretroviral therapy ( ART ) reduces morbidity in children infected with the human immunodeficiency virus ( HIV ) .
BACKGROUND	We investigated whether children and adolescents receiving long-term ART in sub-Saharan Africa could discontinue co-trimoxazole .
METHODS	We conducted a randomized , noninferiority trial of stopping versus continuing daily open-label co-trimoxazole in children and adolescents in Uganda and Zimbabwe .
METHODS	Eligible participants were older than 3 years of age , had been receiving ART for more than 96 weeks , were using insecticide-treated bed nets ( in malaria-endemic areas ) , and had not had Pneumocystis jirovecii pneumonia .
METHODS	Coprimary end points were hospitalization or death and adverse events of grade 3 or 4 .
RESULTS	A total of 758 participants were randomly assigned to stop or continue co-trimoxazole ( 382 and 376 participants , respectively ) , after receiving ART for a median of 2.1 years ( interquartile range , 1.8 to 2.3 ) .
RESULTS	The median age was 7.9 years ( interquartile range , 4.6 to 11.1 ) , and the median CD4 T-cell percentage was 33 % ( interquartile range , 26 to 39 ) .
RESULTS	Participants who stopped co-trimoxazole had higher rates of hospitalization or death than those who continued ( 72 participants [ 19 % ] vs. 48 [ 13 % ] ; hazard ratio , 1.64 ; 95 % confidence interval [ CI ] , 1.14 to 2.37 ; P = 0.007 ; noninferiority not shown ) .
RESULTS	There was no evidence of variation across ages ( P = 0.93 for interaction ) .
RESULTS	A total of 2 participants in the prophylaxis-stopped group ( 1 % ) died , as did 3 in the prophylaxis-continued group ( 1 % ) .
RESULTS	Most hospitalizations in the prophylaxis-stopped group were for malaria ( 49 events , vs. 21 in the prophylaxis-continued group ) or infections other than malaria ( 53 vs. 25 ) , particularly pneumonia , sepsis , and meningitis .
RESULTS	Rates of adverse events of grade 3 or 4 were similar in the two groups ( hazard ratio , 1.20 ; 95 % CI , 0.83 to 1.72 ; P = 0.33 ) , but more grade 4 adverse events occurred in the prophylaxis-stopped group ( hazard ratio , 2.04 ; 95 % CI , 0.99 to 4.22 ; P = 0.05 ) , with anemia accounting for the largest number of events ( 12 , vs. 2 with continued prophylaxis ) .
CONCLUSIONS	Continuing co-trimoxazole prophylaxis after 96 weeks of ART was beneficial , as compared with stopping prophylaxis , with fewer hospitalizations for both malaria and infection not related to malaria .
CONCLUSIONS	( Funded by the United Kingdom Medical Research Council and others ; ARROW Current Controlled Trials number , ISRCTN24791884 . )

###24813374
OBJECTIVE	This study seeks to determine if variation in the dopamine transporter gene ( SLC6A3/DAT1 ) moderates the dose-response effects of long-acting dexmethylphenidate ( D-MPH ) and mixed amphetamine salts ( MAS ) in children with attention-deficit/hyperactivity disorder ( ADHD ) .
METHODS	Fifty-six children and adolescents ( mean age = 11.72.2 ) participated in a double-blind , two period crossover , dose-response study with a randomized placebo week in each 4 week drug period .
METHODS	Each period consisted of sequential week-long exposures to three dose levels ( 10 , 20 , 25-30mg , depending upon weight ) of D-MPH or MAS .
RESULTS	Doses of 10-20mg of either D-MPH or MAS had little to no effect on hyperactivity-impulsivity and total ADHD symptom scores in subjects with the 9/9 genotype ; this was in contrast to the dose-response curves of subjects with either the 10/10 or 10/9 genotype .
CONCLUSIONS	ADHD youth with the 9/9 genotype may require higher stimulant doses to achieve adequate symptom control .

###24758775
BACKGROUND	Ultrasound guidance for continuous femoral perineural catheters may be supplemented by electrical stimulation through a needle or through a stimulating catheter .
BACKGROUND	The authors tested the primary hypothesis that ultrasound guidance alone is noninferior on both postoperative pain scores and opioid requirement and superior on at least one of the two .
BACKGROUND	Second , the authors compared all interventions on insertion time and incremental cost .
METHODS	Patients having knee arthroplasty with femoral nerve catheters were randomly assigned to catheter insertion guided by : ( 1 ) ultrasound alone ( n = 147 ) ; ( 2 ) ultrasound and electrical stimulation through the needle ( n = 152 ) ; or ( 3 ) ultrasound and electrical stimulation through both the needle and catheter ( n = 138 ) .
METHODS	Noninferiority between any two interventions was defined for pain as not more than 0.5 points worse on a 0 to 10 verbal response scale and for opioid consumption as not more than 25 % greater than the mean .
RESULTS	The stimulating needle group was significantly noninferior to the stimulating catheter group ( difference [ 95 % CI ] in mean verbal response scale pain score [ stimulating needle vs. stimulating catheter ] of -0.16 [ -0.61 to 0.29 ] , P < 0.001 ; percentage difference in mean IV morphine equivalent dose of -5 % [ -25 to 21 % ] , P = 0.002 ) and to ultrasound-only group ( difference in mean verbal response scale pain score of -0.28 [ -0.72 to 0.16 ] , P < 0.001 ; percentage difference in mean IV morphine equivalent dose of -2 % [ -22 to 25 % ] , P = 0.006 ) .
RESULTS	In addition , the use of ultrasound alone for femoral nerve catheter insertion was faster and cheaper than the other two methods .
CONCLUSIONS	Ultrasound guidance alone without adding either stimulating needle or needle/catheter combination thus seems to be the best approach to femoral perineural catheters .

###24408976
OBJECTIVE	To investigate monthly and seasonal variations in the progression of myopia in children enrolled in the Correction of Myopia Evaluation Trial ( COMET ) .
METHODS	An ethnically diverse cohort of 469 myopic 6 - to < 12 year-old children was randomized to single vision or progressive addition lenses and followed for 3 years with 98.5 % retention .
METHODS	Progression of myopia was measured semiannually by noncycloplegic autorefraction ( Nidek ARK 700A ) and annually by cycloplegic autorefraction , with the former measurements used in these analyses .
METHODS	The semiannual progression rate was calculated as ( change in spherical equivalent refraction between two consecutive semiannual visits/number of days between the two visits ) times 182.5 .
METHODS	Months were categorized as the midpoint between two visit dates .
METHODS	Seasons were classified as winter ( October through March ) or summer ( April through September ) .
METHODS	The seasonal difference was tested using a linear mixed model adjusting for demographic variables ( age , sex , ethnicity ) , baseline refraction , and treatment group .
RESULTS	Data from 358 children ( mean [ SD ] age = 9.84 1.27 years ; mean myopia = -2.54 0.84 diopters [ D ] ) met the criteria for these analyses .
RESULTS	Myopia progression varied systematically by month ; it was slower in April through September than in the other months .
RESULTS	Mean progression in winter was -0.35 0.34 D and in summer was -0.14 0.32 D , a statistically significant difference ( 0.21 D , P < 0.0001 ) .
RESULTS	The same seasonal pattern was found by age , sex , ethnicity ( except in the small sample of Asians ) , lens type , and clinical center .
CONCLUSIONS	The slower progression of myopia found in summer is likely related to children 's spending more time outdoors and fewer hours in school .
CONCLUSIONS	The data have clinical implications regarding the time of year and the frequency with which myopic children have eye examinations and the need for precise timing of visits in clinical trials testing new myopia treatments .
CONCLUSIONS	( ClinicalTrials.gov number , NCT00000113 . )

###24937648
OBJECTIVE	Few studies use longitudinal data to identify predictors of colorectal cancer screening ( CRCS ) .
OBJECTIVE	We examined predictors of ( 1 ) initial CRCS during the first year of a randomized trial , and ( 2 ) repeat CRCS during the second year of the trial among those that completed FOBT in Year 1 .
METHODS	The sample comprised 1247 participants of the Systems of Support to Increase Colorectal Cancer Screening ( SOS ) Trial ( Group Health Cooperative , August 2008 to November 2011 ) .
METHODS	Potential predictors of CRCS were identified with logistic regression and included sociodemographics , health history , and validated scales of psychosocial constructs .
RESULTS	Prior CRCS ( OR 2.64 , 95 % CI 1.99-3 .52 ) and intervention group ( Automated : OR 2.06 95 % CI 1.43-2 .95 ; Assisted : OR 4.03 , 95 % CI 2.69-6 .03 ; Navigated : OR 5.64 , 95 % CI 3.74-8 .49 ) were predictors of CRCS completion at Year 1 .
RESULTS	For repeat CRCS at Year 2 , prior CRCS at baseline ( OR 1.97 , 95 % CI 1.25-3 .11 ) , intervention group ( Automated : OR 9.27 , 95 % CI 4.56-18 .82 ; Assisted : OR 11.17 , 95 % CI 5.44-22 .94 ; Navigated : OR 13.10 , 95 % CI 6.33-27 .08 ) , and self-efficacy ( OR 1.32 , 95 % CI 1.00-1 .73 ) were significant predictors .
CONCLUSIONS	Self-efficacy and prior CRCS are important predictors of future screening behavior .
CONCLUSIONS	CRCS completion increased when access barriers were removed through interventions .

###24621255
OBJECTIVE	In a 30 week , double-blind , randomized , controlled Phase 3 study in patients with type 2 diabetes mellitus , the addition of fixed-dose exenatide twice daily ( BID ) to titrated insulin glargine resulted in significant glycated hemoglobin ( HbA ( 1c ) ) lowering and weight loss without increased hypoglycemia risk versus titrated insulin glargine alone .
OBJECTIVE	Because individualized insulin titration contributed to these results , this post-hoc analysis examined the results in the context of the degree of insulin titration that occurred .
METHODS	Subjects on pre-existing insulin glargine ( with or without oral antidiabetes agents ) were randomized to placebo ( n = 123 ) or exenatide BID ( n = 138 ; 5g for 4 weeks , then 10g ongoing ) .
METHODS	Insulin glargine was titrated in both arms per the Treat-to-Target algorithm .
METHODS	Tertiles ( T1 , T2 , T3 ) were based on change in insulin dose from baseline to endpoint .
METHODS	Change in HbA ( 1c ) , hypoglycemia risk , and weight gain were assessed per insulin dose tertile .
RESULTS	The population comprised adult patients ( mean age = 59y ) with type 2 diabetes and an HbA ( 1c ) level between 7.0 % and 10.5 % ( mean HbA ( 1c ) = 8.4 % ) .
RESULTS	Insulin titration ranged from modest reductions in T1 to substantial increases in T3 .
RESULTS	Greater improvements in HbA1c were demonstrated with exenatide BID versus placebo in all tertiles ( statistically significant in T2 and T3 ) .
RESULTS	With exenatide BID , more subjects achieved HbA ( 1c ) < 7.0 % vs. placebo : T1 , 44 % vs. 29 % ( P = not significant ) ; T2 , 65 % vs. 26 % ; T3 , 54 % vs. 29 % ( P < 0.05 for T2 and T3 ) .
RESULTS	Incidence of hypoglycemia was numerically lower with exenatide BID in all tertiles .
RESULTS	Adjunctive exenatide BID was associated with statistically significantly greater weight loss ( T1 , T2 ) or mitigation of weight gain ( T3 ) compared with placebo .
RESULTS	Rates of nausea ( 42 % vs. 8 % ) , diarrhea ( 18 % vs. 7 % ) , and vomiting ( 18 % vs. 4 % ) were higher with exenatide BID than with placebo and did not vary by tertile .
CONCLUSIONS	Addition of fixed-dose exenatide BID to optimized insulin glargine , regardless of the extent of insulin titration , significantly improved glycemia without increasing hypoglycemia risk , while mitigating insulin-induced weight gain in this post-hoc analysis .

###25074698
BACKGROUND	Remote ischemic preconditioning ( RIPC ) harnesses an innate defensive mechanism that protects against inflammatory activation and ischemia-reperfusion injury , known sequelae of cardiac surgery with cardiopulmonary bypass .
BACKGROUND	We sought to determine the impact of RIPC on clinical outcomes and physiological markers related to ischemia-reperfusion injury and inflammatory activation after cardiac surgery in children .
RESULTS	Overall , 299 children ( aged neonate to 17 years ) were randomized to receive an RIPC stimulus ( inflation of a blood pressure cuff on the left thigh to 15 mm Hg above systolic for four 5-minute intervals ) versus a blinded sham stimulus during induction with a standardized anesthesia protocol .
RESULTS	Primary outcome was duration of postoperative hospital stay , with serial clinical and laboratory measurements for the first 48 postoperative hours and clinical follow-up to discharge .
RESULTS	There were no significant baseline differences between RIPC ( n = 148 ) and sham ( n = 151 ) .
RESULTS	There were no in-hospital deaths .
RESULTS	No significant difference in length of postoperative hospital stay was noted ( sham 5.4 versus RIPC 5.6 days ; difference +0.2 ; adjusted P = 0.91 ) , with the 95 % confidence interval ( -0.7 to +0.9 ) excluding a prespecified minimal clinically significant differences of 1 or 1.5 days .
RESULTS	There were few significant differences in other clinical outcomes or values at time points or trends in physiological markers .
RESULTS	Benefit was not observed in specific subgroups when explored through interactions with categories of age , sex , surgery type , Aristotle score , or first versus second half of recruitment .
RESULTS	Adverse events were similar ( sham 5 % , RIPC 6 % ; P = 0.68 ) .
CONCLUSIONS	RIPC is not associated with important improvements in clinical outcomes and physiological markers after cardiac surgery in children .
BACKGROUND	clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00650507 .

###25100231
BACKGROUND	Despite the rapid rise in the implementation of electronic health records ( EHR ) , commensurate improvements in health care quality have not been consistently observed .
OBJECTIVE	To evaluate whether the implementation of EHRs and complementary interventions-including clinical decision support , technical assistance , and financial incentives-improved quality of care .
METHODS	The study included 143 practices that implemented EHRs as part of the Primary Care Information Project-a long-standing community-based EHR implementation initiative .
METHODS	A total of 71 practices were randomized to receive financial incentives and quality feedback and 72 were randomized to feedback alone .
METHODS	All practices received technical assistance and had clinical decision support in their EHR .
METHODS	Using data from 2009 to 2011 , we estimated measure-level fixed effects models to evaluate the association between exposure to clinical decision support , technical assistance , financial incentives , and quality of care .
METHODS	Associations were estimated separately for 4 cardiovascular measures that were rewarded by the financial incentive program and 4 measures that were not rewarded by incentives .
RESULTS	Financial incentives for quality were consistently associated with higher performance for the incentivized measures [ +10.1 percentage points at 18 mo of exposure ( approximately +22 % ) , P < 0.05 ] and lower performance for the unincentivized measures [ -8.3 percentage points at 12 mo of exposure ( approximately -20 % ) , P < 0.05 ] .
RESULTS	Technical assistance was associated with higher quality for the unincentivized measures , but not for the incentivized measures .
CONCLUSIONS	Technical assistance and financial incentives-alongside EHR implementation-can improve quality of care .
CONCLUSIONS	Financial incentives for quality may not result in similar improvements for incentivized and unincentivized measures .

###24731535
BACKGROUND	Bariatric surgery improves glycaemia in obese people with type 2 diabetes , but its effects are uncertain in overweight people with this disease .
BACKGROUND	We aimed to identify whether laparoscopic adjustable gastric band surgery can improve glucose control in people with type 2 diabetes who were overweight but not obese .
METHODS	We did an open-label , parallel-group , randomised controlled trial between Nov 1 , 2009 , and June 30 , 2013 , at one centre in Melbourne , Australia .
METHODS	Patients aged 18-65 years with type 2 diabetes and a BMI between 25 and 30 kg/m2 were randomly assigned ( 1:1 ) , by computer-generated random sequence , to receive either multidisciplinary diabetes care plus laparoscopic adjustable gastric band surgery or multidisciplinary diabetes care alone .
METHODS	The primary outcome was diabetes remission 2 years after randomisation , defined as glucose concentrations of less than 7.0 mmol/L when fasting and less than 11.1 mmol/L 2 h after 75 g oral glucose , at least two days after stopping glucose-lowering drugs .
METHODS	Analysis was by intention to treat .
METHODS	This trial is registered with the Australian New Zealand Clinical Trials Registry , number ACTRN12609000286246 .
RESULTS	51 patients were randomised to the multidisciplinary care plus gastric band group ( n = 25 ) or the multidisciplinary care only group ( n = 26 ) , of whom 23 participants and 25 participants , respectively , completed follow-up to 2 years .
RESULTS	12 ( 52 % ) participants in the multidisciplinary care plus gastric band group and two ( 8 % ) participants in the multidisciplinary care only group achieved diabetes remission ( difference in proportions 0.44 , 95 % CI 0.17-0 .71 ; p = 0.0012 ) .
RESULTS	One ( 4 % ) participant in the gastric band group needed revisional surgery and four others ( 17 % ) had a total of five episodes of food intolerance due to excessive adjustment of the band .
CONCLUSIONS	When added to multidisciplinary care , laparoscopic adjustable gastric band surgery for overweight people with type 2 diabetes improves glycaemic control with an acceptable adverse event profile .
CONCLUSIONS	Laparoscopic adjustable gastric band surgery is a reasonable treatment option for this population .
BACKGROUND	Monash University Centre for Obesity Research and Education and Allergan .

###25311708
OBJECTIVE	To determine whether premature infants ' sleep organization , total sleep time , and arousals may be modulated while on a conformational positioner that provides boundaries , customized positioning , and containment compared with standard positioning ( standard crib mattress ) .
METHODS	A proof of concept trial using a within subject crossover design was conducted among 25 premature infants with feeding difficulties .
METHODS	Infants of 31.5 weeks gestational age served as their own control during overnight polysomnography at postconceptual age 38.4 weeks .
METHODS	Each baby received both interventions ( order randomized ) , 1 for each one-half of the 10.5-hour study .
RESULTS	Use of the conformational positioner resulted in higher sleep efficiency of 61 % vs 54 % for the standard mattress ( P < .05 ) .
RESULTS	The interventions did not differ for percent active sleep , percent quiet sleep , percent indeterminate sleep , or spontaneous arousals .
RESULTS	Sleep efficiency was higher on the conformational positioner than standard positioning for surgical subjects and for subjects with necrotizing enterocolitis or gastroschisis ( n = 10 ) .
RESULTS	The surgical subjects ( n = 9 ) had lower sleep efficiency , lower percentage of active sleep , and more spontaneous arousals compared with the nonsurgical group .
CONCLUSIONS	The use of the conformational positioner improved sleep efficiency vs the standard mattress in premature infants with feeding difficulties .
CONCLUSIONS	Infants requiring surgery or with gastrointestinal diagnoses may be more susceptible to environmental stress .

###24506234
OBJECTIVE	Increased interest in antiaging methods , mandates a development of reliable noninvasive technique to assess skin aging .
OBJECTIVE	In this study , we aimed to determine the effects of photoaging at histopathologic resolution by means of reflectance confocal microscopy .
METHODS	The sun-exposed malar area , the anterior aspect of ear lobule , and the sun-protected posterior aspect of ear lobule had been evaluated in 120 volunteers from different age groups over 10 previously reported and new confocal parameters for skin aging .
RESULTS	The sun-exposed areas revealed more frequent irregular honeycomb pattern , polycylic papillary contours , coarse collagen , huddled collagen , curled bright structures with higher epidermal thickness , and furrow depth values .
RESULTS	However , the incidence of thin reticulated collagen and the number of dermal papillae were statistically higher on the sun-protected posterior aspect of ear lobule .
CONCLUSIONS	Reflectance confocal microscopy is a reliable diagnostic technique for evaluation of skin photoaging with objective criteria .
CONCLUSIONS	With the new emerging compact models it is possible to scan even the least accessible body parts with no discomfort to the patient , which offers the possibility to assess the effect of antiaging applications and to identify early signs of solar damage in cosmetically sensitive areas .

###25216510
OBJECTIVE	To assess the dose-ranging efficacy and safety of LX4211 , a dual inhibitor of sodium-glucose cotransporter ( SGLT ) 1 and SGLT2 , in type 2 diabetes .
METHODS	Type 2 diabetic patients inadequately controlled on metformin were randomly assigned to 75 mg once daily , 200 mg once daily , 200 mg twice daily , or 400 mg once daily of LX4211 or placebo .
METHODS	Primary end point was A1C change from baseline to week 12 .
METHODS	Secondary end points included changes in blood pressure ( BP ) and body weight .
RESULTS	Baseline characteristics in 299 patients randomly assigned to LX4211 or placebo in this 12-week dose-ranging study were similar : mean age 55.9 years , A1C 8.1 % ( 65 mmol/mol ) , BMI 33.1 kg/m ( 2 ) , and BP 124/79 mmHg .
RESULTS	LX4211 significantly reduced A1C to week 12 in a dose-dependent manner by 0.42 % ( 4.6 mmol/mol ) , 0.52 % ( 5.7 mmol/mol ) , 0.80 % ( 8.7 mmol/mol ) , and 0.92 % ( 10.0 mmol/mol ) , respectively ( P < 0.001 each ) , compared with 0.09 % ( 1.0 mmol/mol ) for placebo .
RESULTS	Greater A1C reductions were produced by 400 mg once a day than 200 mg once a day LX4211 without higher urinary glucose excretion , suggesting a contribution of SGLT1 inhibition .
RESULTS	Significant reductions were seen in body weight ( -1.85 kg ; P < 0.001 ) and systolic BP ( -5.7 mmHg ; P < 0.001 ) , but diastolic BP was unchanged ( -1.6 ; P = 0.164 ) .
RESULTS	Adverse events with LX4211 were mild to moderate and similar to placebo , including urinary tract infections and gastrointestinal-related events ; genital infections were limited to LX4211 groups ( 0-5 .0 % ) .
RESULTS	No hypoglycemia occurred .
CONCLUSIONS	Dual inhibition of SGLT1/SGLT2 with LX4211 produced significant dose-ranging improvements in glucose control without dose-increasing glucosuria and was associated with reductions in weight and systolic BP in metformin-treated patients with type 2 diabetes .

###25728152
BACKGROUND	The purpose of this study was to evaluate the safety of a novel silver-impregnated Foley catheter system designed to prevent catheter-associated bacteriuria and funguria , assess recruitment feasibility for a future pivotal trial , and preliminarily assess efficacy .
METHODS	This single-center , randomized controlled trial at a university hospital involved adult neurosurgical patients expected to have a urinary catheter for 24 hours .
METHODS	Subjects were randomized to a novel silver-impregnated ( test ) Foley catheter system or a control system .
METHODS	They were followed for 30 days ( or until discharge ) while catheterized and for up to 48 hours after catheter removal , with daily bacteriuria testing and assessment for symptoms of infection and catheter intolerance .
RESULTS	Ninety-five subjects were randomized ( intention-to-treat [ ITT ] population ) .
RESULTS	Of these , 61 subjects ( 64 % ) had a catheter for 24 hours without perioperative antibiotics beyond 24 hours ( evaluable population ) .
RESULTS	In the ITT population , 11 of 95 ( 12 % ) subjects had an asymptomatic bacteriuria ( ABU ) event .
RESULTS	Compared with controls , test system recipients had a trend toward longer time to ABU in the ITT population ( P = .08 , log-rank test ) and a longer time to ABU in the evaluable population ( P = .03 ) .
RESULTS	All 6 ABU events caused by gram-negative bacilli occurred in the control group .
CONCLUSIONS	In this pilot randomized trial the test system was well tolerated and seemingly effective in preventing catheter-associated bacteriuria , especially with gram-negative bacilli .
CONCLUSIONS	A pivotal study is warranted .

###25899888
OBJECTIVE	To report 5-year follow-up data of a randomized study comparing high ligation and stripping ( HL + S ) with high ligation and endovenous laser ablation ( HL + EVLA ) of the great saphenous vein ( GSV ) .
METHODS	One hundred patients were randomized .
METHODS	After 5 years , patient satisfaction with the overall result , CEAP-C class , VCSS , CIVIQ2 quality of life score , and recurrence rate were assessed ( clinical examination and duplex ultrasound ) .
RESULTS	Five-year follow-up rates were 83 % HL + S and 68 % HL + EVLA .
RESULTS	Patient satisfaction with the overall result was rated good or very good by 88 % after HL + S and 87 % after HL + EVLA .
RESULTS	There were significant improvements for both groups in CEAP-C class ( HL + S 2.28 vs. 1.19 ; HL + EVLA 2.3 vs. 1.17 ) , VCSS ( HL + S 4.79 vs. 1.81 ; HL + EVLA 4.13 vs. 1.87 ) , and CIVIQ2 score ( HL + S 82 vs. 94 ; HL + EVLA 75 vs. 93 ) ( p < .001 ) .
RESULTS	There was no difference in recurrence rates on clinical examination and duplex ultrasound ( HL + S 55 % vs. HL + EVLA 40 % ; p = .217 ) .
RESULTS	A reopened or residual incompetent GSV-partial or complete-was found in 24 % ( HL + S ) and 40 % ( HL + EVLA ) , respectively ( p = .141 ) .
CONCLUSIONS	Varicose vein surgery is followed by favorable clinical results and high patient satisfaction , with no difference between HL + S and HL + EVLA .

###24478320
BACKGROUND	The randomized , double-blind phase III AFFIRM trial demonstrated that enzalutamide , an oral androgen receptor inhibitor , significantly prolonged overall survival ( OS ) [ median 18.4 versus 13.6 months ( hazard ratio , HR ) 0.63 ( 95 % confidence interval , CI , 0.53-0 .75 ) ; P < 0.001 ] compared with placebo in patients with metastatic castration-resistant prostate cancer who received prior docetaxel chemotherapy .
METHODS	A post hoc analysis was carried out to assess the efficacy and safety of enzalutamide on outcomes in younger ( < 75 years ) and elderly ( 75 years ) patients in the AFFIRM population .
METHODS	Statistics are presented by age group ( < 75 years , 75 years ) for efficacy outcomes of OS , radiographic progression-free survival ( rPFS ) , time to prostate-specific antigen ( PSA ) progression , PSA response , and safety .
RESULTS	OS was significantly improved with enzalutamide over placebo in patients < 75 years [ median not yet reached versus 13.6 months ; HR 0.63 ( 95 % CI 0.52-0 .78 ) , P < 0.001 ] and in patients 75 years [ median 18.2 versus 13.3 months ; HR 0.61 ( 95 % CI 0.43-0 .86 ) , P = 0.004 ] , respectively .
RESULTS	rPFS was similarly improved in both the younger [ HR 0.45 ( 95 % CI 0.38-0 .53 ) , P < 0.001 ] and elderly patient cohorts [ HR 0.27 ( 95 % CI 0.20-0 .37 ) , P < 0.001 ] relative to placebo , as were time to PSA progression and PSA response .
RESULTS	Adverse events ( AEs ) were similar between the two enzalutamide age groups , with the exception of an increase in patients75 years in the rates of all grade peripheral edema ( 22.1 % versus 12.5 % ) , fatigue ( 39.7 % versus 31.6 % ) , and diarrhea ( 26.6 % versus 19.6 % ) .
RESULTS	The overall grade3 AE rates were low with no major difference in frequency or severity between age groups or treatment arms .
RESULTS	Five patients were reported with seizure events ; three patients < 75 years and two patients 75 years .
CONCLUSIONS	Enzalutamide significantly improves outcomes in both younger ( < 75 years ) and elderly patients ( 75 years ) , with comparable safety and tolerability .

###24884910
OBJECTIVE	This study sought to evaluate the feasibility of a pilot , dyad-based lifestyle intervention , the Unidas por la Vida program , for improving weight loss and dietary intake among high-risk Mexican American mothers who have Type 2 diabetes and their overweight/obese adult daughters .
METHODS	Mother-daughter dyads ( N = 89 ) were recruited from two federally qualified health centers and randomly assigned to either the Unidas intervention or to the control condition .
METHODS	The 16-week Unidas intervention consisted of the following : ( a ) four group meetings , ( b ) eight home visits , and ( c ) booster telephone calls by a lifestyle community coach .
METHODS	The control condition consisted of educational materials mailed to participants ' homes .
METHODS	Participants completed surveys at T1 ( baseline ) and T2 ( 16 weeks ) that assessed various demographic , social network involvement , and dietary variables .
RESULTS	Unidas participants lost significantly more weight at T2 ( p < .003 ) compared with the control participants .
RESULTS	Furthermore , intervention participants also were more likely to be eating foods with lower glycemic load ( p < .001 ) and less saturated fat ( p = .004 ) at T2 .
RESULTS	Unidas participants also reported a significant increase in health-related social support and social control ( persuasion control only ) and a decrease in undermining .
CONCLUSIONS	The Unidas program promoted weight loss and improved dietary intake , as well as changes in diet-related involvement of participants ' social networks .
CONCLUSIONS	The results from this study demonstrate that interventions that draw upon multiple people who share a health-risk have the potential to foster significant changes in lifestyle behaviors and in social network members ' health-related involvement .
CONCLUSIONS	Future research that builds on these findings is needed to elucidate the specific dyadic and social network processes that may drive health behavior change .

###25792557
BACKGROUND	Despite its salutary effects on health , aerobic exercise is often avoided after receipt of an implantable cardioverter defibrillator ( ICD ) because of fears that exercise may provoke acute arrhythmias .
BACKGROUND	We prospectively evaluated the effects of a home aerobic exercise training and maintenance program ( EX ) on aerobic performance , ICD shocks , and hospitalizations exclusively in ICD recipients .
RESULTS	A total of 160 patients ( 124 men and 36 women ) were randomly assigned who had an ICD for primary ( 43 % ) or secondary ( 57 % ) prevention to EX or usual care ( UC ) .
RESULTS	The primary outcome was peak oxygen consumption , measured with cardiopulmonary exercise testing at baseline and 8 and 24 weeks .
RESULTS	EX consisted of 8 weeks of home walking for 1 h/d , 5 d/wk at 60 % to 80 % of heart rate reserve , followed by 16 weeks of maintenance home walking for 150 min/wk .
RESULTS	Adherence to EX was determined from exercise logs , ambulatory heart rate recordings of exercise , and weekly telephone contacts .
RESULTS	Patients assigned to UC received no exercise directives and were monitored by monthly telephone contact .
RESULTS	Adverse events were identified by ICD interrogations , patient reports , and medical charts .
RESULTS	ICD recipients averaged 5512 years and mean ejection fraction of 40.615.7 ; all were taking - blocker medications .
RESULTS	EX significantly increased peak oxygen consumption ( EX , 26.77.0 mL/kg per minute ; UC , 23.96.6 mL/kg per minute ; P = 0.002 ) at 8 weeks , which persisted during maintenance exercise at 24 weeks ( EX , 26.97.7 mL/kg per minute ; UC , 23.46.0 mL/kg per minute ; P < 0.001 ) .
RESULTS	ICD shocks were infrequent ( EX = 4 versus UC = 8 ) , with no differences in hospitalizations or deaths between groups .
CONCLUSIONS	Prescribed home exercise is safe and significantly improves cardiovascular performance in ICD recipients without causing shocks or hospitalizations .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00522340 .

###25231564
BACKGROUND	In order to further improve the methodology and quality of data collection in homeopathic drug provings ( HDP ) , there is a need for a minimum standardised HDP protocol .
BACKGROUND	The objective of the present study was to test the feasibility of this type of protocol .
METHODS	The study protocol embraced a multi-centre , randomised , double-blind , placebo-controlled trial with 2 parallel groups .
METHODS	It was approved by an ethics review committee .
METHODS	During the pre-approval phase , discordances between the regulatory and homeopathic requirements for the protocol were checked and solutions found .
METHODS	The study medication was Potentilla anserina .
METHODS	6 participants received verum and 4 placebo .
METHODS	The resulting symptom list will be published elsewhere .
METHODS	The procedure was accepted by all participants .
RESULTS	Three important issues were addressed : the requirement to keep all participants blinded ; the adverse events reporting to regulatory authorities ; and the necessity of a placebo control group .
RESULTS	Other issues that need further investigations were identified , e.g. sample size , observation period and dosage regimen .
CONCLUSIONS	A minimum protocol of a HDP is feasible .
CONCLUSIONS	All important design elements of HDP could be solved in discussions with the respective regulatory authorities , and participating homeopaths accepted the procedure .

###24841018
BACKGROUND	Different studies underline the use of pre-operative antibiotic prophylaxis in clean surgeries like herniotomy and inguinal orchiopexy .
BACKGROUND	But , the meta-analyses do not recommend nor discard the use of prophylactic pre-operative antibiotics .
BACKGROUND	The scarcity of controlled clinical trials in paediatric population further vitiates the matter .
BACKGROUND	This study assessed the difference in the rate of early post-operative wound infection cases in children who received single dose of pre-operative antibiotics and children who did not receive antibiotics after inguinal herniotomy and orchiopexy .
METHODS	This randomised prospective study was conducted in Paediatric Surgery department of PGIMER Chandigarh .
METHODS	Out of 251 patients , 112 patients were randomised to the case group and 139 were ascribed to the control group .
METHODS	The patients in control group were given a standard regimen of single dose of intravenous antibiotic at the time of induction followed by 3-4 days of oral antibiotic .
METHODS	Case group patients underwent the surgical procedure in similar manner with no antibiotic either at the time of induction or post-operatively .
RESULTS	The incidence of surgical site infection in case group was 3.73 % and that in control group was 2.22 % .
RESULTS	The observed difference in the incidence of surgical site infection was statistically insignificant ( P value = 0.7027 ) .
RESULTS	The overall infection rate in case and control group was 2.89 % .
CONCLUSIONS	Our preliminary experience suggests that there is no statistically significant difference in the proportion of early post-operative wound infection between the patients who received single dose of pre-operative antibiotics and the patients who received no antibiotics after inguinal herniotomy and orchiopexy .
CONCLUSIONS	The risk of surgical site infection in paediatric heriotomies does not increase even if the child 's weight is less than his/her expected weight for age .

###24660763
BACKGROUND	Blood donation is known to contribute to iron deficiency in regular blood donors .
BACKGROUND	This study investigated the safety and efficacy of postdonation iron replacement to mitigate iron deficiency in blood donors .
METHODS	A total of 282 female whole blood donors aged 18 to 45 were prospectively randomized in a double-blinded placebo controlled trial to receive an 8-week postdonation course of carbonyl iron ( 45mg daily ) or placebo .
METHODS	The primary endpoint was prevalence of iron deficiency ( ferritin < 15ng/mL ) at 12 weeks postdonation .
METHODS	Secondary endpoints were eligibility to donate based on capillary hemoglobin ( Hb ) and incidence of gastrointestinal ( GI ) complaints .
RESULTS	Ferritin levels at Week 12 were significantly higher in donors receiving carbonyl iron ( 17.010.9 ng/mL ) compared with those receiving placebo ( 10.68.4 ng/mL ; p < 0.001 ) .
RESULTS	The proportion of iron-deficient donors was significantly lower in the carbonyl iron group ( 51.9 % ) compared to the placebo ( 80.5 % ; p < 0.001 ) .
RESULTS	The mean Hb level in the carbonyl iron group ( 134.68.7 g/L ) was significantly higher than in the placebo arm ( 130.09.9 g/L ; p < 0.001 ) , significantly improving eligibility to donate at Week 12 .
RESULTS	Significantly more donors receiving carbonyl iron had at least one GI side effect ( p < 0.001 ) .
RESULTS	Importantly , 86.7 % of donors receiving carbonyl iron indicated that they would take iron on an ongoing basis .
CONCLUSIONS	An 8-week postdonation course of 45mg of carbonyl iron significantly reduced iron deficiency and was well tolerated in female whole blood donors .
CONCLUSIONS	Postdonation iron replacement may have a role in a broader strategy to optimize donor iron status .

###24699050
OBJECTIVE	Severe atherosclerosis in the aortic arch is associated with a high risk of recurrent vascular events , but the optimal antithrombotic strategy is unclear .
METHODS	This prospective randomized controlled , open-labeled trial , with blinded end point evaluation ( PROBE design ) tested superiority of aspirin 75 to 150 mg/d plus clopidogrel 75 mg/d ( A+C ) over warfarin therapy ( international normalized ratio 2-3 ) in patients with ischemic stroke , transient ischemic attack , or peripheral embolism with plaque in the thoracic aorta > 4 mm and no other identified embolic source .
METHODS	The primary end point included cerebral infarction , myocardial infarction , peripheral embolism , vascular death , or intracranial hemorrhage .
METHODS	Follow-up visits occurred at 1 month and then every 4 months post randomization .
RESULTS	The trial was stopped after 349 patients were randomized during a period of 8 years and 3 months .
RESULTS	After a median follow-up of 3.4 years , the primary end point occurred in 7.6 % ( 13/172 ) and 11.3 % ( 20/177 ) of patients on A+C and on warfarin , respectively ( log-rank , P = 0.2 ) .
RESULTS	The adjusted hazard ratio was 0.76 ( 95 % confidence interval , 0.36-1 .61 ; P = 0.5 ) .
RESULTS	Major hemorrhages including intracranial hemorrhages occurred in 4 and 6 patients in the A+C and warfarin groups , respectively .
RESULTS	Vascular deaths occurred in 0 patients in A+C arm compared with 6 ( 3.4 % ) patients in the warfarin arm ( log-rank , P = 0.013 ) .
RESULTS	Time in therapeutic range ( 67 % of the time for international normalized ratio 2-3 ) analysis by tertiles showed no significant differences across groups .
CONCLUSIONS	Because of lack of power , this trial was inconclusive and results should be taken as hypothesis generating .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00235248 .

###24222323
BACKGROUND	A ` fast-track protocol ' in surgery suggests the application of evidence-based practices to expedite patient recovery .
BACKGROUND	It has shown to reduce hospital stay , hasten recovery as well as facilitate earlier return to work .
BACKGROUND	It has a considerable impact in reducing healthcare costs .
BACKGROUND	The basic tenet is to treat the patient 's disease by minimal disturbance of their physiology .
BACKGROUND	The protocol encompasses pre-operative , intra-operative and post-operative interventions which when carried out together would show maximal benefits .
BACKGROUND	The surgeon is usually the leader of the team managing the patient , but it can not be over-emphasised that this is a multi-disciplinary team approach .
METHODS	We conducted a prospective interventional study to investigate whether ` fast-track ' surgery protocols improve patient outcome when compared to traditional peri-operative care followed at our institute .
METHODS	By doing so , we observed that the patients who underwent ` fast tracking ' required lesser analgesia , had earlier ambulation , earlier return of intestinal motility , were free from tubes , catheters and drains earlier and lastly were discharged earlier .
METHODS	This was achieved without a rise in complications or re-admissions .
CONCLUSIONS	The results have proved that implementing the fast-track protocol for gastrointestinal surgeries is not only safe and effective , but also improves patient outcome .

###24947950
OBJECTIVE	Role of prophylactic antibiotics in Milligan Morgan hemorrhoidectomy - A prospective , randomized control trial .
METHODS	Randomized control trial .
METHODS	Combined Military Hospital Malir , Bannu and HIT hospital Taxilla , September 2008 to February 2011 .
METHODS	Patients undergoing Milligan Morgan hemorrhoidectomy for grade III and IV hemorrhoids were randomized in 2 groups by using computer generated table .
METHODS	Group A did not receive any prophylactic antibiotic whereas group B received 500 mg I/V metronidazole and 1 g Ceftriaxone I/V before induction of anesthesia .
METHODS	All the patients had standardized post operative care .
METHODS	Pain scores on 100 mm Visual Analogue Scale and consumption of oral analgesics were noted from 1st to 7th post operative day .
METHODS	Time required for complete healing was also noted .
METHODS	Data was entered on SPSS 16.0 and p value was calculated .
RESULTS	Out of 100 patients , 96 patients ( 47 in group A and 49 in group B ) completed the study .
RESULTS	Demographical data was comparable in both the groups .
RESULTS	There was no difference in the pain scores , analgesic consumption and rate of healing between both the groups .
CONCLUSIONS	Prophylactic antibiotics have got no role in cases of Milligan Morgan hemorrhoidectomy .

###24260184
BACKGROUND	Cardiac troponin is the biochemical gold standard to diagnose acute myocardial infarction .
BACKGROUND	Interestingly however , elevated cardiac troponin concentrations are also frequently observed during and after endurance-type exercise .
BACKGROUND	Oxidative stress associated with prolonged exercise has been proposed to contribute to cardiac troponin release .
BACKGROUND	Therefore , the aim of this study was to assess the effect of 4 week astaxanthin supplementation ( a potent cartenoid antioxidant ) on antioxidant capacity and exercise-induced cardiac troponin release in cyclists .
METHODS	Thirty-two well-trained male cyclists ( age 255 , weight 737 kg , maximum O2 uptake 605 mLkg ( -1 ) min ( -1 ) , Wmax 5.40.5 Wkg ( -1 ) ; mean SD ) were repeatedly subjected to a laboratory based standardized exercise protocol before and after 4 weeks of astaxanthin ( 20 mg/day ) , or placebo supplementation in a double-blind randomized manner .
METHODS	Blood samples were obtained at baseline , at 60 min of cycling and immediately post-exercise ( 120 min ) .
RESULTS	The pre-supplementation cycling trial induced a significant rise of median cardiac troponin T concentrations from 3.2 ( IQR 3.0-4 .2 ) to 4.7 ng/L ( IQR 3.7-6 .7 ) , immediately post-exercise ( p < 0.001 ) .
RESULTS	Four weeks of astaxanthin supplementation significantly increased mean basal plasma astaxanthin concentrations from non-detectable values to 17586 gkg ( -1 ) .
RESULTS	However , daily astaxanthin supplementation had no effect on exercise-induced cardiac troponin T release ( p = 0.24 ) , as measured by the incremental area under the curve .
RESULTS	Furthermore , the elevation in basal plasma astaxanthin concentrations was not reflected in changes in antioxidant capacity markers ( trolox equivalent antioxidant capacity , uric acid , and malondialdehyde ) .
RESULTS	Markers of inflammation ( high-sensitivity C-reactive protein ) and exercise-induced skeletal muscle damage ( creatine kinase ) were equally unaffected by astaxanthin supplementation .
CONCLUSIONS	Despite substantial increases in plasma astaxanthin concentrations , astaxanthin supplementation did not improve antioxidant capacity in well-trained cyclists .
CONCLUSIONS	Accordingly , exercise-induced cardiac troponin T concentrations were not affected by astaxanthin supplementation .
BACKGROUND	ClinicalTrials.gov NCT01241877 .

###24315312
OBJECTIVE	To assess the differences in facial skin temperature after mandibular third molar removal when patients received methylprednisolone and placebo , respectively and to assess the correlation between patient-reported swelling using a visual analog scale ( VAS ) and facial skin temperature measured using thermography .
METHODS	The study involved patients with 2 mandibular third molars with an indication for removal .
METHODS	The patients received either methylprednisolone or placebo in a randomized , crossover study design .
METHODS	Thermograms and the swelling VAS score were recorded 2 days after surgery .
METHODS	The outcome variable was the temperature difference ( t ) between the operated and control sides .
METHODS	A 2-sample t test analyzed the difference in t between the first and second operations .
METHODS	Spearman 's rank correlation analysis was used to assess the correlation between the swelling VAS scores and the t.
RESULTS	A total of 124 patients ( 67 males , 57 females , mean age 25 years ) had both mandibular third molars removed on 2 separate occasions .
RESULTS	No difference in t was found when methylprednisolone and placebo were given ( P = .07 ) .
RESULTS	In addition , the correlation between the swelling VAS score and t was 0.30 ( P = .001 ) and 0.09 ( P = .3 ) after the first and second operation , respectively .
CONCLUSIONS	Thermography does not seem sensitive enough to detect differences in the inflammatory response when patients received methylprednisolone or placebo .
CONCLUSIONS	The correlation between the t and patient-reported swelling was low ( 0.3 ) .

###25533307
BACKGROUND	Posterior rectal dissection during ileal pouch-anal anastomosis ( IPAA ) can be performed in the total mesorectal excision ( TME ) or close rectal dissection ( CRD ) plane .
BACKGROUND	The aim of this study was to compare morbidity and quality of life ( QoL ) in patients having TME or CRD during proctectomy followed by IPAA for benign disease .
METHODS	In this randomized clinical trial , patients undergoing IPAA were allocated to TME or CRD .
METHODS	Thirty-day morbidity was determined and QoL assessed using Short Form 36 , GIQLI ( GastroIntestinal Quality of Life Index ) and COREFO ( COloREctal Functional Outcome ) questionnaires .
METHODS	The primary outcome ( pouch compliance ) of the trial is to be reported separately .
RESULTS	Fifty-nine patients were included , 28 in the CRD and 31 in the TME group .
RESULTS	Baseline data were similar , except for more previous abdominal surgery in the TME group .
RESULTS	Operating time was longer for patients having CRD ( 195min versus 166min for TME ; P = 0008 ) .
RESULTS	More patients in the TME group had a primary defunctioning ileostomy ( 7 of 31 versus 1 of 28 for CRD ; P = 0055 ) .
RESULTS	Severe complications occurred more frequently in the TME group ( 10 of 31 versus 2 of 28 for CRD ) .
RESULTS	QoL was better in the CRD group for several subscales of the questionnaires measured at 1 , 3 and 6 months after surgery .
RESULTS	At 12 months , QoL was similar in the two groups for all subscales .
CONCLUSIONS	CRD led to a lower severe complication rate and better short-term QoL than wide TME .

###24351876
BACKGROUND	Chronic peanut consumption is associated with health benefits .
BACKGROUND	To encourage consumption , peanuts are marketed with various flavorings , but questions have been raised as to whether seasonings offset the benefits of peanuts alone .
OBJECTIVE	This study sought to determine whether flavorings on peanuts affect health benefits over 12 wk .
METHODS	In a randomized , parallel-group trial , 151 participants received 42 g peanuts/d as 14-g servings of 3 different flavors ( n = 50 ) or a single flavor ( n = 25-26 / group ) .
METHODS	Anthropometric indexes , blood pressure , and heart rate were measured biweekly .
METHODS	Cardiovascular disease risk factors ( serum lipids , insulin , glucose , and cortisol ) were assessed monthly .
RESULTS	No single added flavor differentially altered body weight , body fat , body mass index , heart rate , or blood indexes in the total sample .
RESULTS	Participants at greater risk of cardiovascular disease had significantly greater mean ( SE ) reductions in diastolic blood pressure ( -5.0 1.7 mm Hg compared with -0.7 0.6 mm Hg ) , cholesterol ( -12.1 8.5 mg/dL compared with +5.6 2.0 mg/dL ) , and triglycerides ( -31.7 15.8 mg/dL compared with +2.3 3.0 mg/dL ) ( n = 27 , 24 , and 15 , respectively ; P < 0.01 ) than did those at lower risk , who did not have significantly different cholesterol or triglyceride concentrations .
RESULTS	Consumption of a variety of flavors led to greater weight gain ( 0.9 0.3 kg ) compared with individual flavors alone ( 0.5 0.2 kg ) ( P < 0.05 ) , but increases in fat and lean masses were not significant .
CONCLUSIONS	Regardless of flavoring , peanut consumption offered significant benefits to participants with elevated serum lipids and blood pressure .
CONCLUSIONS	Sensory variety led to a small , but significant , increase in body weight in comparison with ingestion of a single flavor but no change in fat mass .

###24807320
OBJECTIVE	To evaluate an evidence-based collaborative depression care intervention adapted to obstetrics and gynecology clinics compared with usual care .
METHODS	A two-site , randomized controlled trial included screen-positive women ( Patient Health Questionnaire-9 score of at least 10 ) who met criteria for major depression , dysthymia , or both ( Mini-International Neuropsychiatric Interview ) .
METHODS	Women were randomized to 12 months of collaborative depression management or usual care ; 6-month , 12-month , and 18-month outcomes were compared .
METHODS	The primary outcomes were change from baseline to 12 months in depression symptoms and functional status .
METHODS	Secondary outcomes included at least 50 % decrease and remission in depressive symptoms , global improvement , treatment satisfaction , and quality of care .
RESULTS	Participants were , on average , 39 years old , 44 % were nonwhite , and 56 % had posttraumatic stress disorder .
RESULTS	Intervention ( n = 102 ) compared with usual care ( n = 103 ) patients had greater improvement in depressive symptoms at 12 months ( P < .001 ) and 18 months ( P = .004 ) .
RESULTS	The intervention group compared with usual care group had improved functioning over the course of 18 months ( P < .05 ) , were more likely to have at least 50 % decrease in depressive symptoms at 12 months ( relative risk [ RR ] 1.74 , 95 % confidence interval [ CI ] 1.11-2 .73 ) , greater likelihood of at least four specialty mental health visits ( 6-month RR 2.70 , 95 % CI 1.73-4 .20 ; 12-month RR 2.53 , 95 % CI 1.63-3 .94 ) , adequate dose of antidepressant ( 6-month RR 1.64 , 95 % CI 1.03-2 .60 ; 12-month RR 1.71 , 95 % CI 1.08-2 .73 ) , and greater satisfaction with care ( 6-month RR 1.70 , 95 % CI 1.19-2 .44 ; 12-month RR 2.26 , 95 % CI 1.52-3 .36 ) .
CONCLUSIONS	Collaborative depression care adapted to women 's health settings improved depressive and functional outcomes and quality of depression care .
BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT01096316 .
METHODS	I.

###24754379
BACKGROUND	Rosacea subtype 1 ( erythematotelangiectatic ) is an inflammatory skin disease with limited treatment options .
BACKGROUND	TDT 068 , a topical drug-free gel containing ultra-deformable Sequessome vesicles , is registered for use in inflammatory skin conditions , but has not been investigated in rosacea .
OBJECTIVE	This postmarketing study aimed to substantiate the effects of TDT 068 in rosacea subtype 1 .
METHODS	Patients aged 18-85 scoring 6-15/30 for the primary and secondary features of the rosacea standard grading system ( RSGS ) were enrolled .
METHODS	Following stratification ( four females/one male ) patients were randomized ( 2:1 ) to receive TDT 068 or vehicle gel for 4weeks .
METHODS	Efficacy was evaluated using the patient-rated rosacea-specific quality of life ( R-QOL ) instrument and investigator-rated RSGS .
METHODS	Adverse events ( AEs ) were monitored throughout .
RESULTS	Of the 61 randomized patients , 58 were eligible for the full analysis set per protocol .
RESULTS	Baseline characteristics were balanced across the groups .
RESULTS	R-QOL symptom construct scores improved slightly from baseline to Week 4 in both groups ( -0.040.51 TDT 068 vs. -0.220.59 vehicle ; P = 0.1990 ) .
RESULTS	Changes in R-QOL total , function and emotion construct scores at Week 4 were similar with TDT 068 and vehicle , but TDT 068 yielded numerically greater increases in total RSGS scores ( -1.551.83 vs. -0.752.38 vehicle ; P = 0.105 ) .
RESULTS	Non-transient erythema improved significantly with TDT 068 at Week 4 ( -0.340.63 vs. -0.050.51 vehicle ; P = 0.044 ) , with 1 grade improvement in 35 % of patients ( vs. 15 % vehicle ; P = 0.039 ) .
RESULTS	Numerically greater improvements in transient erythema and telangiectasia were also seen with TDT 068 .
RESULTS	Three treatment-related AEs were reported but no serious AEs occurred .
CONCLUSIONS	These data , based on investigator assessment , provide evidence for the good tolerability of drug-free TDT 068 as well as modest improvements in the symptoms of erythematotelangiectatic rosacea .

###25301455
BACKGROUND	Amiodarone is an effective medication in preventing atrial fibrillation ( AF ) , but it interferes with the metabolism of warfarin .
OBJECTIVE	This study sought to examine the association of major thrombotic clinical events and bleeding with the use of amiodarone in the ARISTOTLE ( Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation ) trial .
METHODS	Baseline characteristics of patients who received amiodarone at randomization were compared with those who did not receive amiodarone .
METHODS	The interaction between randomized treatment and amiodarone was tested using a Cox model , with main effects for randomized treatment and amiodarone and their interaction .
METHODS	Matching on the basis of a propensity score was used to compare patients who received and who did not receive amiodarone at the time of randomization .
RESULTS	In ARISTOTLE , 2,051 ( 11.4 % ) patients received amiodarone at randomization .
RESULTS	Patients on warfarin and amiodarone had time in the therapeutic range that was lower than patients not on amiodarone ( 56.5 % vs. 63.0 % ; p < 0.0001 ) .
RESULTS	More amiodarone-treated patients had a stroke or a systemic embolism ( 1.58 % / year vs. 1.19 % / year ; adjusted hazard ratio [ HR ] : 1.47 , 95 % confidence interval [ CI ] : 1.03 to 2.10 ; p = 0.0322 ) .
RESULTS	Overall mortality and major bleeding rates were elevated , but were not significantly different in amiodarone-treated patients and patients not on amiodarone .
RESULTS	When comparing apixaban with warfarin , patients who received amiodarone had a stroke or a systemic embolism rate of 1.24 % / year versus 1.85 % / year ( HR : 0.68 , 95 % CI : 0.40 to 1.15 ) , death of 4.15 % / year versus 5.65 % / year ( HR : 0.74 , 95 % CI : 0.55 to 0.98 ) , and major bleeding of 1.86 % / year versus 3.06 % / year ( HR : 0.61 , 95 % CI : 0.39 to 0.96 ) .
RESULTS	In patients who did not receive amiodarone , the stroke or systemic embolism rate was 1.29 % / year versus 1.57 % / year ( HR : 0.82 , 95 % CI : 0.68 to 1.00 ) , death was 3.43 % / year versus 3.68 % / year ( HR : 0.93 , 95 % CI : 0.83 to 1.05 ) , and major bleeding was 2.18 % / year versus 3.03 % / year ( HR : 0.72 , 95 % CI : 0.62 to 0.84 ) .
RESULTS	The interaction p values for amiodarone use by apixaban treatment effects were not significant .
CONCLUSIONS	Amiodarone use was associated with significantly increased stroke and systemic embolism risk and a lower time in the therapeutic range when used with warfarin .
CONCLUSIONS	Apixaban consistently reduced the rate of stroke and systemic embolism , death , and major bleeding compared with warfarin in amiodarone-treated patients and patients who were not on amiodarone .

###24517060
OBJECTIVE	To evaluate the clinical efficacy and safety of treatment of chronic primary glomerulopathy ( CPG ) patients of Shen deficiency and dampness heat syndrome ( SDDHS ) by Yishen Qingli Granule ( YQG ) combined with low-dose Tripterygium Wilfordii multiglycoside Tablet ( TWT ) .
METHODS	Totally 231 CPG patients of SDDHS were enrolled in this study ( including 60 patients from First Affiliated Hospital of Nanjing University of Chinese Medicine , 58 from First Affiliated Hospital of Nanjing Medical University , 46 from Xinqiao Hospital of Third Military Medical University , 35 from First Affiliated Hospital of Guangzhou University of Chinese Medicine , 14 from First Affiliated Hospital of Soochow University , and 18 from Wuxi Affiliated Hospital of Nanjing University of Chinese Medicine ) .
METHODS	They were randomly assigned to the control group ( 116 cases ) and the trial group ( 115 cases ) according to block group method .
METHODS	There were 217 cases in the safety analysis set ( 109 cases in the trial group vs 108 cases in the control group ) , and 203 cases in the full analysis set ( 99 cases in the trial group vs 104 cases in the control group ) .
METHODS	All patients received basic treatment such as ACEI/ARB .
METHODS	Furthermore , YQG ( consisting of raw astragalus 10 g , prepared Polygonum Multiflorum 10 g , Pyrrosia 10 g , 1.5 g each package , containing 10 g of crude drugs ) was additionally given to patients in the trial group , each package , twice daily .
METHODS	The TWT ( 10 mg ) was given , twice a day .
METHODS	The TWT dose was adjusted according to 24 h urinary total protein ( UTP ) .
METHODS	The placebos of YQG and TWT were administered to those in the control group .
METHODS	The treatment course consisted of 24 weeks and the follow-up visit lasted for 24 weeks .
METHODS	The biochemical indices were observed before and after treatment including 24 h UTP , urine red cell count ( U ( RBC ) ) , renal functions ( BUN , SCr ) , blood routine test ( WBC ) , and liver functions ( SGPT , SGOT ) .
METHODS	Reverse reactions such as gastrointestinal discomfort , skin rash , and irregular menstruation were also observed .
RESULTS	Compared with the control group , the total effective rate was better in the trial group ( 82.83 % vs 61.54 % , P < 0.01 ) .
RESULTS	Results of stratified comparison of UTP showed better efficacy in the trial group ( 0.8-3 .0 g/24 h , P < 0.01 ) .
RESULTS	The UTP decline occurred in the trial group after 8 weeks of treatment , with stable action , showing statistical difference when compared with the control group ( P < 0.01 ) .
RESULTS	In the trial group , U ( RBC ) level decreased after treatment but changed more significantly .
RESULTS	But there was no statistical difference in the changes when compared with the control group ( P > 0.05 ) .
RESULTS	After treatment , there were no statistical difference in safety indicators such as WBC , SGPT , and SGOT between the two groups after treatment ( P > 0.05 ) .
CONCLUSIONS	On the basis of basic treatment such as ACEI/ARB , application of YQG combined with low-dose TWT had better effect in controlling proteinuria of CPG patients , and could help stabilizing their conditions with less adverse reactions .

###25799130
BACKGROUND	It has been suggested that pancreaticogastrostomy ( PG ) is a safer reconstruction than pancreaticojejunostomy ( PJ ) , resulting in lower morbidity , including lower pancreatic leak rates and decreased postoperative mortality .
BACKGROUND	We compared PJ and PG after pancreaticoduodenectomy ( PD ) .
METHODS	A randomized clinical trial was designed .
METHODS	It was stopped with 50 % accrual .
METHODS	Patients underwent either PG or PJ reconstruction .
METHODS	The primary outcome was the pancreatic fistula rate , and the secondary outcomes were overall morbidity and mortality .
METHODS	We used the Student t , Mann-Whitney U and ( 2 ) tests for intention to treat analysis .
METHODS	The effect of randomization , American Society of Anesthesiologists score , soft pancreatic texture and use of pancreatic stent on overall complications and fistula rates was calculated using logistic regression .
RESULTS	Our trial included 98 patients .
RESULTS	The rate of pancreatic fistula formation was 18 % in the PJ and 25 % in the PG groups ( p = 0.40 ) .
RESULTS	Postoperative complications occurred in 48 % of patients in the PJ and 58 % in the PG groups ( p = 0.31 ) .
RESULTS	There were no significant predictors of overall complications in the multivariate analysis .
RESULTS	Only soft pancreatic gland predicted the occurrence of pancreatic fistula ( odds ratio 5.89 , p = 0.003 ) .
CONCLUSIONS	There was no difference in the rates of pancreatic leak/fistula , overall complications or mortality between patients undergoing PG and and those undergoing PJ after PD .

###24281237
OBJECTIVE	This study aims to determine the dose-dependent effects of testosterone on sexual function , body composition , muscle performance , and physical function in hysterectomized women with or without oophorectomy .
METHODS	Seventy-one postmenopausal women who previously underwent hysterectomy with or without oophorectomy and had total testosterone levels less than 31 ng/dL or free testosterone levels less than 3.5 pg/mL received a standardized transdermal estradiol regimen during the 12-week run-in period and were randomized to receive weekly intramuscular injections of placebo or 3 , 6.25 , 12.5 , or 25 mg of testosterone enanthate for 24 weeks .
METHODS	Total and free testosterone levels were measured by liquid chromatography-tandem mass spectrometry and equilibrium dialysis , respectively .
METHODS	The primary outcome was change in sexual function measured by the Brief Index of Sexual Functioning for Women .
METHODS	Secondary outcomes included changes in sexual activity , sexual distress , Derogatis Interview for Sexual Functioning , lean body mass , fat mass , muscle strength and power , and physical function .
RESULTS	Seventy-one women were randomized ; five groups were similar at baseline .
RESULTS	Sixty-two women with analyzable data for the primary outcome were included in the final analysis .
RESULTS	The mean on-treatment total testosterone concentrations were 19 , 78 , 102 , 128 , and 210 ng/dL in the placebo , 3-mg , 6.25-mg , 12.5-mg , and 25-mg groups , respectively .
RESULTS	Changes in composite Brief Index of Sexual Functioning for Women scores , thoughts/desire , arousal , frequency of sexual activity , lean body mass , chest-press power , and loaded stair-climb power were significantly related to increases in free testosterone concentrations ; compared with placebo , changes were significantly greater in women assigned to the 25-mg group , but not in women in the lower-dose groups .
RESULTS	Sexual activity increased by 2.7 encounters per week in the 25-mg group .
RESULTS	The frequency of androgenic adverse events was low .
CONCLUSIONS	Testosterone administration in hysterectomized women with or without oophorectomy for 24 weeks was associated with dose and concentration-dependent gains in several domains of sexual function , lean body mass , chest-press power , and loaded stair-climb power .
CONCLUSIONS	Long-term trials are needed to weigh improvements in these outcomes against potential long-term adverse effects .

###25536308
OBJECTIVE	To determine whether active negative pressure peritoneal therapy with the ABThera temporary abdominal closure device reduces systemic inflammation after abbreviated laparotomy .
BACKGROUND	Excessive systemic inflammation after abdominal injury or intra-abdominal sepsis is associated with poor outcomes .
METHODS	We conducted a single-center , randomized controlled trial .
METHODS	Forty-five adults with abdominal injury ( 46.7 % ) or intra-abdominal sepsis ( 52.3 % ) were randomly allocated to the ABThera ( n = 23 ) or Barker 's vacuum pack ( n = 22 ) .
METHODS	On study days 1 , 2 , 3 , 7 , and 28 , blood and peritoneal fluid were collected .
METHODS	The primary endpoint was the difference in the plasma concentration of interleukin-6 ( IL-6 ) 24 and 48 hours after temporary abdominal closure application .
RESULTS	There was a significantly lower peritoneal fluid drainage from the ABThera at 48 hours after randomization .
RESULTS	Despite this , there was no difference in plasma concentration of IL-6 at baseline versus 24 ( P = 0.52 ) or 48 hours ( P = 0.82 ) between the groups .
RESULTS	There was also no significant intergroup difference in the plasma concentrations of IL-1 , -8 , -10 , or -12 p70 or tumor necrosis factor between these time points .
RESULTS	The cumulative incidence of primary fascial closure at 90 days was similar between groups ( hazard ratio , 1.6 ; 95 % confidence interval , 0.82-3 .0 ; P = 0.17 ) .
RESULTS	However , 90-day mortality was improved in the ABThera group ( hazard ratio , 0.32 ; 95 % confidence interval , 0.11-0 .93 ; P = 0.04 ) .
CONCLUSIONS	This trial observed a survival difference between patients randomized to the ABThera versus Barker 's vacuum pack that did not seem to be mediated by an improvement in peritoneal fluid drainage , fascial closure rates , or markers of systemic inflammation .
BACKGROUND	ClinicalTrials.gov identifier NCT01355094 .

###24622416
BACKGROUND	Type 1 diabetes results from T-cell-mediated destruction of cells .
BACKGROUND	Findings from preclinical studies and pilot clinical trials suggest that antithymocyte globulin ( ATG ) might be effective for reducing this autoimmune response .
BACKGROUND	We assessed the safety and efficacy of rabbit ATG in preserving islet function in participants with recent-onset type 1 diabetes , and report here our 12-month results .
METHODS	For this phase 2 , randomised , placebo-controlled , clinical trial , we enrolled patients with recent-onset type 1 diabetes , aged 12-35 years , and with a peak C-peptide of 0.4 nM or greater on mixed meal tolerance test from 11 sites in the USA .
METHODS	We used a computer generated randomisation sequence to randomly assign patients ( 2:1 , with permuted-blocks of size three or six and stratified by study site ) to receive either 6.5 mg/kg ATG or placebo over a course of four days .
METHODS	All participants were masked and initially managed by an unmasked drug management team , which managed all aspects of the study until month 3 .
METHODS	Thereafter , to maintain masking for diabetes management throughout the remainder of the study , participants received diabetes management from an independent , masked study physician and nurse educator .
METHODS	The primary endpoint was the baseline-adjusted change in 2-h area under the curve C-peptide response to mixed meal tolerance test from baseline to 12 months .
METHODS	Analyses were by intention to treat .
METHODS	This is a planned interim analysis of an on-going trial that will run for 24 months of follow-up .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00515099 .
RESULTS	Between Sept 10 , 2007 , and June 1 , 2011 , we screened 154 individuals , randomly allocating 38 to ATG and 20 to placebo .
RESULTS	We recorded no between-group difference in the primary endpoint : participants in the ATG group had a mean change in C-peptide area under the curve of -0.195 pmol/mL ( 95 % CI -0.292 to -0.098 ) and those in the placebo group had a mean change of -0.239 pmol/mL ( -0.361 to -0.118 ) in the placebo group ( p = 0.591 ) .
RESULTS	All except one participant in the ATG group had both cytokine release syndrome and serum sickness , which was associated with a transient rise in interleukin-6 and acute-phase proteins .
RESULTS	Acute T cell depletion occurred in the ATG group , with slow reconstitution over 12 months .
RESULTS	However , effector memory T cells were not depleted , and the ratio of regulatory to effector memory T cells declined in the first 6 months and stabilised thereafter .
RESULTS	ATG-treated patients had 159 grade 3-4 adverse events , many associated with T-cell depletion , compared with 13 in the placebo group , but we detected no between-group difference in incidence of infectious diseases .
CONCLUSIONS	Our findings suggest that a brief course of ATG does not result in preservation of - cell function 12 months later in patients with new-onset type 1 diabetes .
CONCLUSIONS	Generalised T-cell depletion in the absence of specific depletion of effector memory T cells and preservation of regulatory T cells seems to be an ineffective treatment for type 1 diabetes .

###24448936
OBJECTIVE	To determine the efficacy of single-dose albendazole ( 400 mg ) for soil-transmitted helminth infections ( STH ) in schoolchildren living in one community of the city of Iquitos , Per .
METHODS	Within the context of a randomized controlled trial performed in a peri-urban community of limited resources located in Iquitos in the Peruvian Amazon , stool specimens were collected from Grade 5 schoolchildren in 18 schools and analysed for STH prevalence and intensity .
METHODS	A total of 1,193 school-age children were then dewormed with single-dose albendazole ( 400 mg ) .
METHODS	Of the 909 children who were found positive with at least one STH infection , a random sample of 385 was followed two weeks later when a second stool specimen was collected and analyzed .
RESULTS	The efficacy of albendazole was satisfactory : for Ascaris lumbricoides , with an egg reduction rate ( ERR ) of 99.8 % ; ( 95 % CI : 99.3-100 ) ; for hookworm , with an ERR of 93.6 % ; ( 95 % CI : 88.2-96 .6 ) and , for Trichuris trichiura , with an ERR of 72.7 % ; ( 95 % CI : 58.5-79 .1 ) .
CONCLUSIONS	These results are consistent with previous data published on the efficacy of albendazole and the directives of the World Health Organization .
CONCLUSIONS	Future research should focus on improving the efficacy of the treatment strategies for Trichuris trichiura infection .

###25158654
OBJECTIVE	Determine the efficacy of a fall-prevention skills training program for patients with cancer and family caregivers .
METHODS	Randomized , controlled trial with repeated measures and postintervention measure of fall occurrence .
METHODS	A comprehensive cancer center in the midwestern United States .
METHODS	132 patient and family caregiver dyads .
METHODS	Dyads were randomly assigned to one of two groups : a control group that received standard fall-prevention education or a treatment group that received standard education and a fall-prevention DVD program to view at home .
METHODS	Participants completed surveys at baseline , one week , one month , and three months .
METHODS	Follow-up phone calls were made at three months .
METHODS	Fall occurrence , perceptions of fall risks , and fall-prevention knowledge .
RESULTS	Patients in the treatment group were significantly more likely to report not falling at three months than patients in the control group .
RESULTS	The number of falls was lower for the treatment group .
RESULTS	The difference was not statistically significant .
RESULTS	Dyads in the treatment group showed significantly greater improvement over time in fall risk awareness and fall-prevention knowledge .
CONCLUSIONS	Mobility skills training is a promising educational intervention for reducing fall occurrences in the home for patients with cancer .
CONCLUSIONS	Efforts are needed for improving the knowledge and skills of cancer survivors and their family members in recognizing patient fall risks , making home adjustments , and performing mobility skills competently .

###25753873
OBJECTIVE	This study examined the usefulness of nasal Duo positive airway pressure ( DuoPAP ) in the treatment of very low birth weight preterm infants with neonatal respiratory distress syndrome ( NRDS ) .
METHODS	Eighty-five very low birth weight preterm infants with NRDS were randomly divided into two groups .
METHODS	Forty-five infants were treated with DuoPAP , while 40 infants were treated using nasal continuous positive airway pressure ( nCPAP ) .
METHODS	The study outcomes were pH , PaCO , PaO , oxygenation index ( PaO/FiO ) , and the number of failure cases at 1 , 12 , and 24 hours after non-invasive respiratory support .
RESULTS	At all studied time points , after non-invasive respiratory support , PaCO , PaO and oxygenation index were significantly ( p < 0.05 ) better in the nasal DuoPAP group compared with nasal CPAP group .
RESULTS	In addition , rates of failure of assisted ventilation ( respectively , 4.44 % vs. 22.50 % ) and the occurrence of apnea ( 13.33 % vs. 32.50 % ) were significantly ( p < 0.05 ) better in the nasal DuoPAP group .
RESULTS	Other parameters ( such as duration of noninvasive ventilation , number of retinopathies of premature children , intraventricular hemorrhages , or periventricular leukomalacias ) were comparable between both non-invasive regimen .
CONCLUSIONS	Nasal DuoPAP better improves oxygenation , reduces CO retention , and diminishes the need for invasive mechanical ventilation and complications in the treatment of NRDS .

###24598375
BACKGROUND	The specific job demands of working in a hospital may place nurses at elevated risk for developing distress , anxiety and depression .
BACKGROUND	Screening followed by referral to early interventions may reduce the incidence of these health problems and promote work functioning .
OBJECTIVE	To evaluate the comparative cost-effectiveness of two strategies to promote work functioning among nurses by reducing symptoms of mental health complaints .
OBJECTIVE	Three conditions were compared : the control condition consisted of online screening for mental health problems without feedback about the screening results .
OBJECTIVE	The occupational physician condition consisted of screening , feedback and referral to the occupational physician for screen-positive nurses .
OBJECTIVE	The third condition included screening , feedback , and referral to e-mental health .
METHODS	The study was designed as an economic evaluation alongside a pragmatic cluster randomised controlled trial with randomisation at hospital-ward level .
METHODS	The study included 617 nurses in one academic medical centre in the Netherlands .
METHODS	Treatment response was defined as an improvement on the Nurses Work Functioning Questionnaire of at least 40 % between baseline and follow-up .
METHODS	Total per-participant costs encompassed intervention costs , direct medical and non-medical costs , and indirect costs stemming from lost productivity due to absenteeism and presenteeism .
METHODS	All costs were indexed for the year 2011 .
RESULTS	At 6 months follow-up , significant improvement in work functioning occurred in 20 % , 24 % and 16 % of the participating nurses in the control condition , the occupational physician condition and the e-mental health condition , respectively .
RESULTS	In these conditions the total average annualised costs were 1752 , 1266 and 1375 per nurse .
RESULTS	The median incremental cost-effectiveness ratio for the occupational physician condition versus the control condition was dominant , suggesting cost savings of 5049 per treatment responder .
RESULTS	The incremental cost-effectiveness ratio for the e-mental health condition versus the control condition was estimated at 4054 ( added costs ) per treatment responder .
RESULTS	Sensitivity analyses attested to the robustness of these findings .
CONCLUSIONS	The occupational physician condition resulted in greater treatment responses for less costs relative to the control condition and can therefore be recommended .
CONCLUSIONS	The e-mental health condition produced less treatment response than the control condition and can not be recommended as an intervention to improve work functioning among nurses .

###25444830
BACKGROUND	We have developed a new oral vaccine against enterotoxigenic Escherichia coli ( ETEC ) , which is the most common cause of bacterial diarrhea in children in developing countries and in travelers .
METHODS	The vaccine was tested for safety and immunogenicity alone and together with double-mutant heat-labile toxin ( dmLT ) adjuvant in a double-blind , placebo-controlled Phase I study in 129 Swedish adults .
METHODS	The vaccine consists of four inactivated recombinant E. coli strains overexpressing the major ETEC colonization factors ( CFs ) CFA/I , CS3 , CS5 , and CS6 mixed with an LT B-subunit related toxoid , LCTBA .
METHODS	Volunteers received two oral doses of vaccine alone , vaccine plus 10 g or 25 g dmLT or placebo .
METHODS	Secretory IgA antibody responses in fecal samples and IgA responses in secretions from circulating intestine-derived antibody secreting cells were assessed as primary measures of vaccine immunogenicity .
RESULTS	The vaccine was safe and well tolerated ; adverse events were few and generally mild with no significant differences between subjects receiving placebo or vaccine with or without adjuvant .
RESULTS	As many as 74 % of subjects receiving vaccine alone and 83 % receiving vaccine plus 10 g dmLT showed significant mucosal IgA responses to all five primary vaccine antigens and about 90 % of all vaccinees responded to at least four of the antigens .
RESULTS	Subjects receiving vaccine plus 10 g dmLT responded with significantly increased intestine-derived anti-CS6 responses compared to subjects receiving vaccine alone .
CONCLUSIONS	The vaccine was safe and broadly immunogenic .
CONCLUSIONS	dmLT further enhanced mucosal immune responses to CF antigens present in low amounts in the vaccine .
CONCLUSIONS	Based on these encouraging results , the vaccine will be tested for safety and immunogenicity in different age groups including infants in Bangladesh and for protective efficacy in travelers .

###25234206
BACKGROUND	In the Action in Diabetes and Vascular Disease : Preterax and Diamicron Modified Release Controlled Evaluation ( ADVANCE ) factorial trial , the combination of perindopril and indapamide reduced mortality among patients with type 2 diabetes , but intensive glucose control , targeting a glycated hemoglobin level of less than 6.5 % , did not .
BACKGROUND	We now report results of the 6-year post-trial follow-up .
METHODS	We invited surviving participants , who had previously been assigned to perindopril-indapamide or placebo and to intensive or standard glucose control ( with the glucose-control comparison extending for an additional 6 months ) , to participate in a post-trial follow-up evaluation .
METHODS	The primary end points were death from any cause and major macrovascular events .
RESULTS	The baseline characteristics were similar among the 11,140 patients who originally underwent randomization and the 8494 patients who participated in the post-trial follow-up for a median of 5.9 years ( blood-pressure-lowering comparison ) or 5.4 years ( glucose-control comparison ) .
RESULTS	Between-group differences in blood pressure and glycated hemoglobin levels during the trial were no longer evident by the first post-trial visit .
RESULTS	The reductions in the risk of death from any cause and of death from cardiovascular causes that had been observed in the group receiving active blood-pressure-lowering treatment during the trial were attenuated but significant at the end of the post-trial follow-up ; the hazard ratios were 0.91 ( 95 % confidence interval [ CI ] , 0.84 to 0.99 ; P = 0.03 ) and 0.88 ( 95 % CI , 0.77 to 0.99 ; P = 0.04 ) , respectively .
RESULTS	No differences were observed during follow-up in the risk of death from any cause or major macrovascular events between the intensive-glucose-control group and the standard-glucose-control group ; the hazard ratios were 1.00 ( 95 % CI , 0.92 to 1.08 ) and 1.00 ( 95 % CI , 0.92 to 1.08 ) , respectively .
CONCLUSIONS	The benefits with respect to mortality that had been observed among patients originally assigned to blood-pressure-lowering therapy were attenuated but still evident at the end of follow-up .
CONCLUSIONS	There was no evidence that intensive glucose control during the trial led to long-term benefits with respect to mortality or macrovascular events .
CONCLUSIONS	( Funded by the National Health and Medical Research Council of Australia and others ; ADVANCE-ON ClinicalTrials.gov number , NCT00949286 . )

###24726311
OBJECTIVE	To evaluate , posthoc , the relationship between serum total testosterone and response to therapy in a study of tadalafil once daily for erectile dysfunction ( ED ) .
METHODS	Men were aged 18 years , with 3-month history of ED and partial prior response to on-demand ( PRN ) phosphodiesterase type 5 inhibitor ( PDE5I ) therapy .
METHODS	A 4-week maximum-dose PRN PDE5I run-in was followed by a 4-week nondrug washout period , then randomization to tadalafil 2.5 mg titrated to 5 mg or tadalafil 5 mg ( pooled for analyses ) or placebo once daily for 12 weeks .
METHODS	Analyses compared endpoint efficacy results between low - ( < 300 ng/dL ) vs normal-testosterone ( 300 ng/dL ) level subgroups .
RESULTS	Improvements for tadalafil vs placebo were significant for the International Index of Erectile Function ( IIEF ) Erectile Function domain , Intercourse Satisfaction domain , Overall Satisfaction domain , and Question 15 ( confidence in the ability to get and keep an erection ; all P < .001 ) , and for the Sexual Encounter Profile Questions 1-5 ( all P. 011 ) .
RESULTS	Analysis of covariance modeling identified significant treatment-by-subgroup interactions for the IIEF-Overall Satisfaction domain and erection confidence question and Sexual Encounter Profile Question 3 .
RESULTS	Comparing between tadalafil-treated testosterone subgroups , the IIEF-Erectile Function domain scores improved significantly more in men with normal vs low testosterone ( P = .022 ) ; no other significant differences were identified for either placebo or tadalafil .
RESULTS	No significant differences in pre-existing conditions were observed between tadalafil and placebo within the normal - and low-testosterone subgroups .
CONCLUSIONS	In men with partial response to a PRN PDE5I , tadalafil 5 mg once daily significantly improved ED and sexual function vs placebo irrespective of testosterone levels .

###24467861
BACKGROUND	Meaning-focused coping may be at the core of adequate adjustment to life after cancer .
BACKGROUND	Cancer survivors who experience their life as meaningful are better adjusted , have better quality of life and psychological functioning .
BACKGROUND	Meaning-Centered Group Psychotherapy for Cancer Survivors ( MCGP-CS ) was designed to help patients to sustain or enhance a sense of meaning and purpose in their lives .
BACKGROUND	The aim of the proposed study is to evaluate the effectiveness and cost-effectiveness of MCGP-CS .
METHODS	Survivors diagnosed with cancer in the last 5 years and treated with curative intent , are recruited via several hospitals in the Netherlands .
METHODS	After screening , 168 survivors are randomly assigned to one of the three study arms : 1 .
METHODS	Meaning-Centered Group Psychotherapy ( MCGP-CS ) 2 .
METHODS	Supportive group psychotherapy ( SGP ) 3 .
METHODS	Care as usual ( CAU ) .
METHODS	Baseline assessment takes place before randomisation , with follow up assessments post-intervention and at 3 , 6 and 12 months follow-up .
METHODS	Primary outcome is meaning making ( PMP , PTGI , SPWB ) .
METHODS	Secondary outcome measures address quality of life ( EORTC-30 ) , anxiety and depression ( HADS ) , hopelessness ( BHS ) , optimism ( LOT-R ) , adjustment to cancer ( MAC ) , and costs ( TIC-P , EQ-5D , PRODISQ ) .
CONCLUSIONS	Meaning-focused coping is key to adjustment to life after cancer , however , there is a lack of evidence based psychological interventions in this area .
CONCLUSIONS	Many cancer survivors experience feelings of loneliness and alienation , and have a need for peer support , therefore a group method in particular , can be beneficial for sustaining or enhancing a sense of meaning .
CONCLUSIONS	If this MCGP-CS is effective for cancer survivors , it can be implemented in the practice of psycho-oncology care .
BACKGROUND	Netherlands Trial Register , NTR3571 .

###25358874
OBJECTIVE	The current standard treatment for IgA nephropathy relies on steroid and/or immunosuppressive therapy and angiotensin converting enzyme inhibitors ( ACEI ) or angiotensin receptor blocker ( ARB ) .
OBJECTIVE	This study examines the benefits and safety of combining valsartan with clopidogrel and leflunomide as a treatment for progressive IgA nephropathy .
METHODS	Patients with primary IgA nephropathy , confirmed by renal biopsy , were recruited for this study .
METHODS	Patients were separated into four groups ( n = 42 each ) after 2 months of run-in period of valsartan treatment .
METHODS	All patients were treated with valsartan alone ( Group 1 ) or valsartan and either clopidogrel ( Group 2 ) or leflunomide ( Group 3 ) or both clopidogrel and leflunomide ( Group 4 ) .
METHODS	Each group was followed up for their next 24 months for 24h urinary protein excretion , serum creatinine and estimated glomerular filtration rate ( eGFR ) to assess the effect of the treatment .
METHODS	Adverse effects were recorded concurrently to evaluate the safety of the treatment .
RESULTS	Of all 168 patients , 107 were males and 61 were females , with an average age of 33.88.79 years .
RESULTS	Baseline characteristics were comparable among the four groups ( P > 0.05 ) prior to the experimental treatment .
RESULTS	There was a significant ( P < 0.05 ) decrease in 24h urinary protein excretion after 4 months of experimental treatment .
RESULTS	At the end of the 24 months , groups 3 and 4 showed a respective 62.35 % and 69.47 % reduction in proteinuria .
RESULTS	The serum creatinine was significantly higher ( P < 0.05 ) in group 1 and 2 at the end of the follow-up , and their respective eGFR was significantly lower .
RESULTS	The incidence of cardiovascular complication was 11.9 % and 9.5 % for group 1 and 3 , respectively .
CONCLUSIONS	The treatment with Valsartan combined with Clopidogrel and Leflunomide can reduce the urinary proteins loss and renal function deterioration for IgA nephropathy patients and cause minimal adverse reactions .
CONCLUSIONS	Our study suggests a new clinical treatment option for IgA nephropathy .

###24947722
OBJECTIVE	This study sought to examine the relationship between left ventricular mass ( LVM ) regression and clinical outcomes after transcatheter aortic valve replacement ( TAVR ) .
BACKGROUND	LVM regression after valve replacement for aortic stenosis is assumed to be a favorable effect of LV unloading , but its relationship to improved clinical outcomes is unclear .
METHODS	Of 2,115 patients with symptomatic aortic stenosis at high surgical risk receiving TAVR in the PARTNER ( Placement of Aortic Transcatheter Valves ) randomized trial or continued access registry , 690 had both severe LV hypertrophy ( left ventricular mass index [ LVMi ] 149 g/m ( 2 ) men , 122 g/m ( 2 ) women ) at baseline and an LVMi measurement at 30-day post-TAVR follow-up .
METHODS	Clinical outcomes were compared for patients with greater than versus lesser than median percentage change in LVMi between baseline and 30 days using Cox proportional hazard models to evaluate event rates from 30 to 365 days .
RESULTS	Compared with patients with lesser regression , patients with greater LVMi regression had a similar rate of all-cause mortality ( 14.1 % vs. 14.3 % , p = 0.99 ) , but a lower rate of rehospitalization ( 9.5 % vs. 18.5 % , hazard ratio [ HR ] : 0.50 , 95 % confidence interval [ CI ] : 0.32 to 0.78 ; p = 0.002 ) and a lower rate of rehospitalization specifically for heart failure ( 7.3 % vs. 13.6 % , p = 0.01 ) .
RESULTS	The association with a lower rate of rehospitalization was consistent across subgroups and remained significant after multivariable adjustment ( HR : 0.53 , 95 % CI : 0.34 to 0.84 ; p = 0.007 ) .
RESULTS	Patients with greater LVMi regression had lower B-type natriuretic peptide ( p = 0.002 ) and a trend toward better quality of life ( p = 0.06 ) at 1-year follow-up than did those with lesser regression .
CONCLUSIONS	In high-risk patients with severe aortic stenosis and severe LV hypertrophy undergoing TAVR , those with greater early LVM regression had one-half the rate of rehospitalization over the subsequent year compared to those with lesser regression .

###24357403
BACKGROUND	Percutaneous coronary interventions in patients with chronic kidney disease have shown suboptimal results .
BACKGROUND	Drug-eluting stents ( DES ) might reduce the rate of target vessel revascularization in comparison with bare-metal stents ( BMS ) in patients with chronic kidney disease .
BACKGROUND	However , given the multiple concomitant individual variables present in such patients , the comparison of neointimal growth after percutaneous coronary intervention is complex and difficult to assess .
RESULTS	Randomized Comparison of Xience V and Multi-Link Vision Coronary Stents in the Same Multivessel Patient with Chronic Kidney Disease ( RENAL-DES ) was a prospective , randomized , multicenter study to directly compare the efficacy in the prevention of clinical restenosis of everolimus-eluting stent ( Xience V ) and BMS with an identical design ( Multi-Link Vision ) , both implanted in the same patient with multivessel coronary artery disease and chronic kidney disease ( estimated glomerular filtration rate < 60 mL/min ) .
RESULTS	The primary end point of the study was the ischemia-driven target vessel revascularization as detected with myocardial scintigraphy at 12 months .
RESULTS	In 215 patients , 512 coronary vessels were successfully treated with the randomly assigned DES ( n = 257 ) or BMS ( n = 255 ) .
RESULTS	At 1 year , the rate of ischemia-driven target vessel revascularization for DES and BMS groups was 2.7 % ( 95 % confidence interval , 1.1 % -5.6 % ) and 11.4 % ( 95 % confidence interval , 7.8 % to 16 % ) , respectively , P < 0.001 .
RESULTS	For the multivariate analysis , independent predictors of the ischemia-driven target vessel revascularization were BMS implantation ( odds ratio , 4.95 ; 95 % confidence interval , 2.1-11 .6 ; P < 0.001 ) and vessel size ( odds ratio , 0.32 ; 95 % confidence interval , 0.1-0 .7 ; P = 0.006 ) .
CONCLUSIONS	This is the first randomized trial showing a reduction of clinical restenosis with a new-generation DES in comparison with a BMS of equal design , in patients who have chronic kidney disease with multivessel coronary artery disease .
BACKGROUND	http://clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00818792 .

###24532525
OBJECTIVE	Emergence agitation ( EA ) is frequently observed in children undergoing general anaesthesia .
OBJECTIVE	This study tested whether the addition of an intra-operative low-dose infusion of dexmedetomidine to fentanyl treatment reduced the incidence of emergence delirium following desflurane anesthesia in children undergoing strabismus surgery .
METHODS	A total of 96 children ( 1-5 years old ) undergoing strabismus surgery were enrolled .
METHODS	Anaesthesia was induced with propofol and maintained with desflurane .
METHODS	After induction , fentanyl ( 1 g/kg ) was administered to all children .
METHODS	During surgery , patients were infused with 0.2 g / ( kgh ) dexmedetomidine ( Group FD , n = 47 ) or normal saline ( Group F , n = 47 ) .
METHODS	Postoperative objective pain score ( OPS ) , Paediatric Agitation and Emergence Delirium ( PAED ) score , and EA score were documented every 10 minutes in the post-anaesthesia care unit .
RESULTS	There were no significant differences between the two groups in demographic characteristics and haemodynamic changes .
RESULTS	The mean values of maximum EA , maximum PAED , and maximum OPS score were significantly lower in Group FD than in Group F at 0 , 10 , and 20 minutes after arrival at the post-anaesthesia care unit ( p < 0.001 ) .
RESULTS	The frequency of fentanyl rescue was lower in Group FD than in Group F ( p < 0.001 ) .
RESULTS	The incidence of severe EA was significantly lower in Group FD than in Group F ( 12.8 % vs. 74.5 % , p < 0.001 ) .
CONCLUSIONS	Intra-operative low-dose infusion of dexmedetomidine in addition to fentanyl reduces EA following desflurane anaesthesia in children undergoing strabismus surgeries .

###25044085
OBJECTIVE	To determine the effect of enclomiphene citrate in men with secondary hypogonadism .
METHODS	Phase II clinical trial .
METHODS	Community dwelling men making visits to physician offices .
METHODS	Men with secondary hypogonadism .
METHODS	Oral administration of enclomiphene citrate or 1 % topical T gel .
METHODS	Luteinizing hormone , FSH , T , and semen analysis .
RESULTS	Treatment with enclomiphene citrate resulted in increased morning serum T , E2 , and LH levels similar to those obtained with a topical T gel in men with secondary hypogonadism .
RESULTS	Follicle-stimulating hormone and LH were increased with enclomiphene , and sperm counts were conserved .
CONCLUSIONS	Enclomiphene citrate reverses the two hallmarks of secondary hypogonadism , namely , low serum total T and low or inappropriately normal LH while preserving sperm production .
BACKGROUND	NCT01270841 ( ClinicalTrials.gov Identifier NCT01270841 ) .

###24732860
METHODS	Randomized prevention trial .
OBJECTIVE	To compare the long-term effect of strengthening versus flexibility exercises and to evaluate the additional effect of abdominal bracing in recurrent low back pain ( LBP ) .
BACKGROUND	No conclusions could be made regarding appropriate exercise types or parameters in recurrent LBP .
BACKGROUND	Abdominal bracing increases trunk stiffness ; however , its long-term effect has not been evaluated in recurrent LBP yet .
METHODS	Six hundred patients with recurrent LBP participated .
METHODS	They were randomized into 4 groups-150 patients ( age : 42.5 12.7 ) performed strengthening exercises ; 150 patients ( age : 41.3 11.5 ) performed flexibility exercises ; 150 patients ( age : 41.0 13.2 ) performed strengthening exercises and used abdominal bracing in daily activities/exercises ; and 150 patients ( age : 40.6 12.3 ) performed flexibility exercises and used abdominal bracing in daily activities/exercises .
METHODS	At the beginning of the study and at the end of 10 consecutive years were recorded 6 outcomes-frequency , intensity , and duration of pain , as well as frequency , intensity , and duration of exercises .
RESULTS	Regarding the first 4 outcomes-all groups showed improvement from the beginning to the second year , but worsening from the second to the 10th year ; there was no difference between strengthening and flexibility groups ; bracing groups showed better results versus nonbracing groups .
RESULTS	Intensity , frequency , and duration of the pain correlated with each other and with frequency of the exercises , but not with exercise duration or intensity .
CONCLUSIONS	The exercise frequency is more important than the type , duration , or intensity of the exercise .
CONCLUSIONS	Abdominal bracing adds to the exercise effect .
CONCLUSIONS	It could be considered as a `` preliminary muscle back belt on demand '' increasing the trunk stiffness and the frequency of the trunk muscle contractions/cocontractions without interruption of daily activities , which may remind/convince the patients to exercise more frequently .
CONCLUSIONS	Frequent exercising and bracing seems effective long-term prevention advices in recurrent LBP .
METHODS	2 .

###24269926
OBJECTIVE	Methotrexate and infliximab are effective therapies for Crohn 's disease ( CD ) .
OBJECTIVE	In the combination of maintenance methotrexate-infliximab trial , we evaluated the potential superiority of combination therapy over infliximab alone .
METHODS	In a 50-week , double-blind , placebo-controlled trial , we compared methotrexate and infliximab with infliximab alone in 126 patients with CD who had initiated prednisone induction therapy ( 15-40 mg/day ) within the preceding 6 weeks .
METHODS	Patients were assigned randomly to groups given methotrexate at an initial weekly dose of 10 mg , escalating to 25 mg/week ( n = 63 ) , or placebo ( n = 63 ) .
METHODS	Both groups received infliximab ( 5 mg/kg of body weight ) at weeks 1 , 3 , 7 , and 14 , and every 8 weeks thereafter .
METHODS	Prednisone was tapered , beginning at week 1 , and discontinued no later than week 14 .
METHODS	The primary outcome was time to treatment failure , defined as a lack of prednisone-free remission ( CD Activity Index , < 150 ) at week 14 or failure to maintain remission through week 50 .
RESULTS	Patients ' baseline characteristics were similar between groups .
RESULTS	By week 50 , the actuarial rate of treatment failure was 30.6 % in the combination therapy group compared with 29.8 % in the infliximab monotherapy group ( P = .63 ; hazard ratio , 1.16 ; 95 % confidence interval , 0.62-2 .17 ) .
RESULTS	Prespecified subgroup analyses failed to show a benefit in patients with short disease duration or an increased level of C-reactive protein .
RESULTS	No clinically meaningful differences were observed in secondary outcomes .
RESULTS	Combination therapy was well tolerated .
CONCLUSIONS	The combination of infliximab and methotrexate , although safe , was no more effective than infliximab alone in patients with CD receiving treatment with prednisone .
CONCLUSIONS	ClincialTrials.gov number , NCT00132899 .

###25399048
BACKGROUND	Knee osteoarthritis ( OA ) is a mechanically driven disease , and it is suggested that medial tibiofemoral knee-joint load increases with pharmacologic pain relief , indicating that pharmacologic pain relief may be positively associated with disease progression .
BACKGROUND	Treatment modalities that can both relieve pain and reduce knee-joint load would be preferable .
BACKGROUND	The knee-joint load is influenced by functional alignment of the trunk , pelvis , and lower-limb segments with respect to the knee , as well as the ground-reaction force generated during movement .
BACKGROUND	Neuromuscular exercise can influence knee load and decrease knee pain .
BACKGROUND	It includes exercises to improve balance , muscle activation , functional alignment , and functional knee stability .
BACKGROUND	The primary objective of this randomized controlled trial ( RCT ) is to investigate the efficacy of a NEuroMuscular EXercise ( NEMEX ) therapy program , compared with optimized analgesics and antiinflammatory drug use , on the measures of knee-joint load in people with mild to moderate medial tibiofemoral knee osteoarthritis .
METHODS	One hundred men and women with mild to moderate medial knee osteoarthritis will be recruited from general medical practices and randomly allocated ( 1:1 ) to one of two 8-week treatments , either ( a ) NEMEX therapy twice a week or ( b ) information on the recommended use of analgesics and antiinflammatory drugs ( acetaminophen and oral NSAIDs ) via a pamphlet and video materials .
METHODS	The primary outcome is change in knee load during walking ( the Knee Index , a composite score of the first external peak total reaction moment on the knee joint from all three planes based on 3D movement analysis ) after 8 weeks of intervention .
METHODS	Secondary outcomes include changes in the external peak knee-adduction moment and impulse and functional performance measures , in addition to changes in self-reported pain , function , health status , and quality of life .
CONCLUSIONS	These findings will help determine whether 8 weeks of neuromuscular exercise is superior to optimized use of analgesics and antiinflammatory drugs regarding knee-joint load , pain and physical function in people with mild to moderate knee osteoarthritis .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01638962 ( July 3 , 2012 ) .

###24384675
BACKGROUND	This study evaluated the long-term effectiveness of multiple physical activity counseling strategies on subjective health among older adults .
METHODS	Sedentary older adults ( n = 442 ) were randomized to 3 programs : ( 1 ) a one-contact referral to locally organized physical activities , ( 2 ) a one-contact provision of a walking program , ( 3 ) a 10-week multiple-contact physical activity coaching based on the Self-Determination Theory .
METHODS	Self-reports on well-being , trait anxiety and physical activity were completed at baseline ( pretest ) , and 10 weeks after ( 10-week follow-up ) , 1 year after ( 1-year follow-up ) and 2 years after ( 2-year follow-up ) pretests .
RESULTS	All 3 programs yielded improvements in well-being and trait anxiety from pretest to 10-week follow-up and to 1-year follow-up .
RESULTS	From pretest to 2-year follow-up , no changes emerged in well-being whereas trait anxiety increased significantly .
RESULTS	Changes over time in well-being and anxiety were not significantly different between the programs .
RESULTS	Changes in physical activity contributed significantly to the prediction of changes in well-being and trait anxiety .
CONCLUSIONS	The findings demonstrate the year-round effectiveness of physical activity counseling on subjective health among older adults , irrespective of counseling strategy .
CONCLUSIONS	However , a relapse to baseline level occurred 2 years after the intervention .
CONCLUSIONS	Physical activity appears to be an important determinant of older adults ' well-being .

###24237037
BACKGROUND	Azathioprine ( AZA ) , a pro-drug metabolised to the active metabolites 6-tioguanine nucleotides ( 6TGN ) , is a steroid-sparing therapy for Crohn 's disease ( CD ) .
OBJECTIVE	To investigate whether AZA therapy is optimised by individualised dosing based on thiopurine methyltransferase ( TPMT ) activity and 6TGN concentrations .
METHODS	This multicentre , double-blind , randomised controlled trial compared the efficacy and safety of weight-based vs. individualised AZA dosing in inducing and maintaining remission in adults and children with steroid-treated CD .
METHODS	The primary outcome was clinical remission ( CR ) at 16 weeks .
METHODS	In the weight-based arm , subjects received 2.5 mg/kg/day .
METHODS	In the individualised dosing arm , the initial AZA dose was 1.0 mg/kg/day ( if intermediate TPMT ) or 2.5 mg/kg/day ( if normal TPMT ) .
METHODS	Starting at week 5 , the dose was adjusted to target 6TGN concentrations of 250-400 pmol/8 10 ( 8 ) red blood cells ( RBC ) , or to a maximal dose of 4 mg/kg/day .
RESULTS	After randomising 50 subjects , the trial was stopped prematurely due to insufficient enrolment .
RESULTS	In intention-to-treat analysis , CR rates at week 16 were 40 % in the individualised arm vs. 16 % in the weight-based arm ( P = 0.11 ) .
RESULTS	In per-protocol ( PP ) analysis , week 16 CR rates were 60 % in the individualised arm and 25 % in the weight-based arm ( P = 0.12 ) .
RESULTS	At week 16 , median 6TGN concentrations in PP remitters and nonremitters were 216 and 149 pmol/8 10 ( 8 ) RBC respectively ( P = 0.07 ) .
CONCLUSIONS	Despite trends favouring individualised over weight-based AZA dosing , there were no statistically significant differences in efficacy , likely due to low statistical power and inability to achieve the target 6TGN concentrations in the individualised arm .
CONCLUSIONS	[ Clinicaltrials.Gov Identifier Nct00113503 ] .

###24246433
OBJECTIVE	To evaluate the efficacy and feasibility of actions intended to implement or improve patients ' social network within the Italian National Health Service community mental health services .
METHODS	We conducted a randomized clinical trial through a network of 47 community mental health services on patients with a diagnosis in the schizophrenia spectrum ( F20 in the International Classification of Diseases , 10th Revision ) , who were young ( aged younger than 45 years ) , and with a poor social network ( less than 5 relationships ) .
METHODS	In addition to routine treatments , for the experimental group , the staff identified possible areas of interest for individual patients and proposed social activities taking place outside the services ' resources and with members of the community .
METHODS	The main outcome was an improvement in the patients ' social network ; secondary end points were clinical outcome , abilities of daily living , and work .
RESULTS	One - and 2-year outcomes of 345 and 327 , respectively , of the 357 patients randomized were analyzed by intention-to-treat .
RESULTS	A social network improvement was observed at year 1 in 25 % of the patients allocated to routine treatment and in 39.9 % of those allocated to the experimental arm ( OR 2.0 , 95 % CI 1.3 to 3.1 ; adjusted OR 2.4 , 95 % CI 1.4 to 3.9 ) .
RESULTS	The difference remained statistically significant at year 2 .
RESULTS	No significant differences emerged for any of the other end points .
RESULTS	However , patients with 1 or more other areas of improvement at year 1 and 2 showed a statistically significant social network improvement .
CONCLUSIONS	The activation of social networks as an activity integrated with standard psychiatric care is practicable , without added economic and organizational costs , and appears to produce an effect persisting well beyond its implementation .

###24934401
BACKGROUND	Serotonin reuptake inhibitors ( SSRIs ) are commonly prescribed off-label for children with autism .
BACKGROUND	To date , clinical trials examining the use of SSRIs in autism have been limited by small sample sizes and inconclusive results .
BACKGROUND	The efficacy and safety of SSRIs for moderating autistic behaviors is yet to be adequately examined to provide evidence to support current clinical practice .
BACKGROUND	The aim of the Fluoxetine for Autistic Behaviors ( FAB ) study is to determine the efficacy and safety of low dose fluoxetine compared with placebo , for reducing the frequency and severity of repetitive stereotypic behaviors in children and adolescents with an autism spectrum disorder ( ASD ) .
BACKGROUND	The relationship between the effectiveness of fluoxetine treatment and serotonin transporter genotype will also be explored .
METHODS	The FAB study is a multicenter , double-blinded , randomized controlled trial , funded by the Australian Government 's National Health and Medical Research Council ( NHMRC ) grant .
METHODS	Participants will be aged between 7.5 and 17 years with a confirmed diagnosis of ASD .
METHODS	Eligible participants will be randomized to either placebo or fluoxetine for a 16-week period .
METHODS	Medication will be titrated over the first four weeks .
METHODS	Reponses to medication will be monitored fortnightly using the Clinical Global Impressions Scale ( CGI ) .
METHODS	The primary outcome measure is the Children 's Yale-Brown Obsessive Compulsive Scale-Modified for Pervasive Developmental Disorders ( CYBOCS-PDD ) , administered at baseline and 16 weeks .
METHODS	Secondary outcome measures include the Aberrant Behaviour Scale ( ABC ) , the Spence Children 's Anxiety Scale Parent Report ( SCAS-P ) , and the Repetitive Behaviors Scale ( RBS-R ) , measured at baseline and 16 weeks .
METHODS	Participants will be invited to undergo genetic testing for SLC6A4 allele variants using a cheek swab .
METHODS	Continuous outcomes , including the primary outcome will be compared between the active and placebo groups using unadjusted linear regression .
METHODS	Binary outcomes will be compared using unadjusted logistic regression .
CONCLUSIONS	The FAB study is a large clinical trial to specifically investigate the efficacy of low dose fluoxetine for restricted , repetitive , and stereotyped behaviors in ASD .
CONCLUSIONS	The outcomes of this study will contribute to evidence-based interventions used in clinical practice to assist children with ASD .
BACKGROUND	Australian and New Zealand Clinical Trials Registry ACTRN12608000173392 ; registered on 9 April , 2008 .

###24395850
OBJECTIVE	Our study examined whether mindfulness-based stress reduction ( MBSR ) is noninferior to cognitive behavioral therapy for insomnia ( CBT-I ) for the treatment of insomnia in patients with cancer .
METHODS	This was a randomized , partially blinded , noninferiority trial involving patients with cancer with insomnia recruited from a tertiary cancer center in Calgary , Alberta , Canada , from September 2008 to March 2011 .
METHODS	Assessments were conducted at baseline , after the program , and after 3 months of follow-up .
METHODS	The noninferiority margin was 4 points measured by the Insomnia Severity Index .
METHODS	Sleep diaries and actigraphy measured sleep onset latency ( SOL ) , wake after sleep onset ( WASO ) , total sleep time ( TST ) , and sleep efficiency .
METHODS	Secondary outcomes included sleep quality , sleep beliefs , mood , and stress .
RESULTS	Of 327 patients screened , 111 were randomly assigned ( CBT-I , n = 47 ; MBSR , n = 64 ) .
RESULTS	MBSR was inferior to CBT-I for improving insomnia severity immediately after the program ( P = .35 ) , but MBSR demonstrated noninferiority at follow-up ( P = .02 ) .
RESULTS	Sleep diary-measured SOL was reduced by 22 minutes in the CBT-I group and by 14 minutes in the MBSR group at follow-up .
RESULTS	Similar reductions in WASO were observed for both groups .
RESULTS	TST increased by 0.60 hours for CBT-I and 0.75 hours for MBSR .
RESULTS	CBT-I improved sleep quality ( P < .001 ) and dysfunctional sleep beliefs ( P < .001 ) , whereas both groups experienced reduced stress ( P < .001 ) and mood disturbance ( P < .001 ) .
CONCLUSIONS	Although MBSR produced a clinically significant change in sleep and psychological outcomes , CBT-I was associated with rapid and durable improvement and remains the best choice for the nonpharmacologic treatment of insomnia .

###24673713
OBJECTIVE	To observe the different concentrations of mycophenolic acid ( MPA ) during the early post-transplant phase for various combinations of cyclosporine A ( CsA ) and tacrolimus ( Tac ) with enteric-coated mycophenolate sodium ( EC-MPS ) .
METHODS	A total of 42 Chinese adults receiving live related donor kidney transplants were studied .
METHODS	All received a triple immunosuppressive regimen of EC-MPS , CsA/Tac and corticosteroids and were divided randomly into CsA ( n = 21 ) and Tac ( n = 21 ) combination groups .
METHODS	The dosage of EC-MPS was the same ( 1440mg/day ) in the two groups .
METHODS	The MPA concentration was evaluated with an enzyme-multiplied immunoassay technique ( EMIT ) and the pharmacokinetic characteristics were investigated in both groups .
RESULTS	The mean maximum plasma concentrations ( Cmax ) of MPA in the CsA and Tac groups were 11.3659.522 and 9.7487.523 g/ml , respectively ( p = 0.137 ) .
RESULTS	The maximum times to Cmax ( Tmax ) were 2.541.53 and 2.671.08 h , respectively ( p = 0.341 ) .
RESULTS	The mean MPA 12-h areas under the curve ( MPA-AUC0-12h ) were 59.46316.252 and 77.53533.615 gh/ml ( p = 0.003 ) and the mean residence times ( MRT ) were 3.710.829 and 3.9280.923 h ( p = 0.038 ) .
CONCLUSIONS	Combined with the same EC-MPS dosage ( 1440mg/day ) , the MPA-AUC0-12 of the Tac group was higher than that of the CsA group , and the Tac group had a longer MRT after kidney transplantation .
CONCLUSIONS	Our data indicate that the concentration of MPA should be monitored in clinical therapy when EC-MPS is combined with different calcineurin inhibitors to reduce acute allograft rejection and avoid adverse events .

###24440931
OBJECTIVE	Functional dyspepsia ( FD ) is a complex disease with a variety of dyspeptic symptoms .
OBJECTIVE	Little is known about the clinical efficacy of cinitapride , a 5-HT agonist and D antagonist , in treating FD .
METHODS	This randomized , double-blind , double-dummy , positive-controlled study compared the efficacy and safety of cinitapride ( 1 mg ) and domperidone ( 10 mg ) tid for 4 weeks in 383 consecutive patients with mild to moderate , postprandial distress syndrome-predominant dyspeptic symptoms according to Rome III criteria .
METHODS	The primary endpoint was the noninferiority of cinitapride compared with domperidone in relief of symptoms .
METHODS	The overall patient evaluation of treatment and open gastric emptying effects of both drugs were treated as the secondary endpoints .
RESULTS	The rates of symptom relief by cinitapride and domperidone after 4 weeks did not differ significantly on intension-to-treat analysis ( 85.8 % vs. 81.8 % , P = 0.332 ) .
RESULTS	Cinitapride significantly reduced the overall severity of postprandial fullness , early satiation , and bloating ( 4.33.9 vs. 17.86.6 , P < 0.001 ) ; and it was superior to the effects of domperidone ( 5.44.9 vs. 18.46.9 , P < 0.001 ; P = 0.021 between groups ) .
RESULTS	Cinitapride also decreased the mean half-gastric emptying time from 131.1119.4 to 86.518.7 minutes ( P = 0.0002 ) .
RESULTS	There was a positive relationship between symptoms and gastric emptying time ( r = 0.332 , P = 0.041 ) .
RESULTS	Cinitapride-related adverse events were observed in 9.1 % of patients , including 1 patient with extrapyramidal symptoms .
RESULTS	No patient experienced QT interval prolongation .
CONCLUSIONS	This phase III trial has confirmed a noninferior efficacy of cinitapride over domperidone for patients with mild to moderate , postprandial distress syndrome-predominant FD .
CONCLUSIONS	Cinitapride usage is well tolerated , but its cardiovascular events need further evaluation .

###24784545
OBJECTIVE	To conduct a randomized controlled trial of Students for Nutrition and eXercise , a 5-week middle school-based obesity-prevention intervention combining school-wide environmental changes , multimedia , encouragement to eat healthy school cafeteria foods , and peer-led education .
METHODS	We randomly selected schools ( five intervention , five waitlist control ) from the Los Angeles Unified School District .
METHODS	School records were obtained for number of fruits and vegetables served , students served lunch , and snacks sold per attending student , representing an average of 1,515 students ( SD = 323 ) per intervention school and 1,524 students ( SD = 266 ) per control school .
METHODS	A total of 2,997 seventh-graders ( 75 % of seventh-graders across schools ) completed pre - and postintervention surveys assessing psychosocial variables .
METHODS	Consistent with community-based participatory research principles , the school district was an equal partner , and a community advisory board provided critical input .
RESULTS	Relative to control schools , intervention schools showed significant increases in the proportion of students served fruit and lunch and a significant decrease in the proportion of students buying snacks at school .
RESULTS	Specifically , the intervention was associated with relative increases of 15.3 % more fruits served ( p = .006 ) , 10.4 % more lunches served ( p < .001 ) , and 11.9 % fewer snacks sold ( p < .001 ) than would have been expected in its absence .
RESULTS	Pre-to-post intervention , intervention school students reported more positive attitudes about cafeteria food ( p = .02 ) and tap water ( p = .03 ) , greater obesity-prevention knowledge ( p = .006 ) , increased intentions to drink water from the tap ( p = .04 ) or a refillable bottle ( p = .02 ) , and greater tap water consumption ( p = .04 ) compared with control school students .
CONCLUSIONS	Multilevel school-based interventions may promote healthy adolescent dietary behaviors .

###24429201
BACKGROUND	Abnormal acid gastro-oesophageal reflux is common in patients with idiopathic pulmonary fibrosis ( IPF ) and is considered a risk factor for development of IPF .
BACKGROUND	Retrospective studies have shown improved outcomes in patients given anti-acid treatment .
BACKGROUND	The aim of this study was to investigate the association between anti-acid treatment and disease progression in IPF .
METHODS	In an analysis of data from three randomised controlled trials , we identified patients with IPF assigned to receive placebo .
METHODS	Case report forms had been designed to prospectively obtain data about diagnosis and treatment of abnormal acid gastro-oesophageal reflux in each trial .
METHODS	The primary outcome was estimated change in forced vital capacity ( FVC ) at 30 weeks ( mean follow-up ) in patients who were and were not using a proton-pump inhibitor or histamine-receptor-2 ( H2 ) blocker .
RESULTS	Of the 242 patients randomly assigned to the placebo groups of the three trials , 124 ( 51 % ) were taking a proton-pump inhibitor or H2 blocker at enrolment .
RESULTS	After adjustment for sex , baseline FVC as a percentage of predicted , and baseline diffusing capacity of the lung for carbon monoxide as a percentage of predicted , patients taking anti-acid treatment at baseline had a smaller decrease in FVC at 30 weeks ( -006 L , 95 % CI -011 to -001 ) than did those not taking anti-acid treatment ( -012 L , -017 to -008 ; difference 007 L , 95 % CI 0-014 ; p = 005 ) .
CONCLUSIONS	Anti-acid treatment could be beneficial in patients with IPF , and abnormal acid gastro-oesophageal reflux seems to contribute to disease progression .
CONCLUSIONS	Controlled clinical trials of anti-acid treatments are now needed .
BACKGROUND	National Institutes of Health .

###24737669
OBJECTIVE	The purpose of this study was to test for moderating effects of patient characteristics on self-management interventions developed to address symptoms during cancer treatment .
OBJECTIVE	Patient 's age , education , and depressive symptomatology were considered as potential moderators .
METHODS	A secondary analysis of data of 782 patients from two randomized clinical trials was performed .
METHODS	Both trials enrolled patients with solid tumors undergoing chemotherapy .
METHODS	After completing baseline interviews , patients were randomized to a nurse-delivered intervention versus intervention delivered by a ` coach ' in trial I and to a nurse-delivered intervention versus an intervention delivered by an automated voice response system in trial II .
METHODS	In each of the two trials , following a six-contact 8-week intervention , patients were interviewed at week 10 to assess the primary outcome of symptom severity .
RESULTS	Although nurse-delivered intervention proved no better than the coach or automated system in lowering symptom severity , important differences in the intervention by age were found in both trials .
RESULTS	Patients aged 45 years responded better to the coach or automated system , whereas those aged 75 years favored the nurse .
RESULTS	Education and depressive symptomatology did not modify the intervention effects in either of the two trials .
RESULTS	Depressive symptomatology had a significant main effect on symptom severity at week 10 in both trials ( p = 0.03 and p < 0.01 , respectively ) .
RESULTS	Education was not associated with symptom severity over and above age and depressive symptomatology .
CONCLUSIONS	Clinicians need to carefully consider the age of the population when using or testing interventions to manage symptoms among cancer patients .

###24416316
BACKGROUND	The Integrated Infectious Diseases Capacity Building Evaluation ( IDCAP ) designed two interventions : Integrated Management of Infectious Disease ( IMID ) training program and On-Site Support ( OSS ) .
BACKGROUND	We evaluated their effects on 23 facility performance indicators , including malaria case management .
METHODS	IMID , a three-week training with two follow-up booster courses , was for two mid - level practitioners , primarily clinical officers and registered nurses , from 36 primary care facilities .
METHODS	OSS was two days of training and continuous quality improvement activities for nine months at 18 facilities , to which all health workers were invited to participate .
METHODS	Facilities were randomized as clusters 11 to parallel OSS `` arm A '' or control `` arm B '' .
METHODS	Outpatient data on four malaria case management indicators were collected for 14 months .
METHODS	Analysis compared changes before and during the interventions within arms ( relative risk = RR ) .
METHODS	The effect of OSS was measured with the difference in changes across arms ( ratio of RR = RRR ) .
RESULTS	The proportion of patients with suspected malaria for whom a diagnostic test result for malaria was recorded decreased in arm B ( adjusted RR ( aRR ) = 0.97 ; 99 % CI : 0.82,1.14 ) during IMID , but increased 25 % in arm A ( aRR = 1.25 ; 99 % CI :0.94 , 1.65 ) during IMID and OSS relative to baseline ; ( aRRR = 1.28 ; 99 % CI :0.93 , 1.78 ) .
RESULTS	The estimated proportion of patients that received an appropriate antimalarial among those prescribed any antimalarial increased in arm B ( aRR = 1.09 ; 99 % CI : 0.87 , 1.36 ) and arm A ( aRR = 1.50 ; 99 % CI : 1.04 , 2.17 ) ; ( aRRR = 1.38 ; 99 % CI : 0.89 , 2.13 ) .
RESULTS	The proportion of patients with a negative diagnostic test result for malaria prescribed an antimalarial decreased in arm B ( aRR = 0.96 ; 99 % CI : 0.84 , 1.10 ) and arm A ( aRR = 0.67 ; 99 % CI : 0.46 , 0.97 ) ; ( aRRR = 0.70 ; 99 % CI : 0.48 , 1.00 ) .
RESULTS	The proportion of patients with a positive diagnostic test result for malaria prescribed an antibiotic did not change significantly in either arm .
CONCLUSIONS	The combination of IMID and OSS was associated with statistically significant improvements in malaria case management .

###24231646
BACKGROUND	Controlling alloimmune humoral response is a challenge in transplantation .
BACKGROUND	Few studies have evaluated the impact of maintenance immunosuppression on blood humoral parameters .
METHODS	We performed a post-hoc analysis on 307 kidney transplant recipients included in a prospective randomized trial comparing tacrolimus/mycophenolate mofetil ( Tac/MMF ) vs. cyclosporine/azathioprine ( CsA/AZA ) , both used with antithymocyte globulin induction and steroids .
METHODS	Humoral parameters were analyzed at D0 , D15 , and M12 .
RESULTS	IgG , IgA , and IgM levels decreased significantly as soon as D15 in both groups ( 35 % , 26 % , and 35 % respectively , vs. D0 ) .
RESULTS	At M12 , although peripheral B-cell counts did not differ between the groups , Tac/MMF regimen was associated with lower IgG , IgA , and IgM levels than CsA/AZA ( 5.9 % , 14.6 % , and 34 % , respectively ) .
RESULTS	Hypogammaglobulinemia at D15 was not associated with an increased risk of infections during the first year .
RESULTS	The proportion of HLA-sensitized patients decreased in the Tac/MMF group ( 15.9 % at D0 and 6.7 % at M12 , p = 0.02 ) and remained stable in the CsA/AZA group ( 10.3 % at D0 and 8.9 % at M12 , p = 0.5 ) .
RESULTS	More patients sensitized at baseline became non-sensitized at M12 with Tac/MMF than with CsA/AZA .
CONCLUSIONS	Our results suggest humoral immunosuppression is better with Tac/MMF than with CsA/AZA during the first year of kidney transplantation .

###25618125
BACKGROUND	Venous leg ulcers ( VLUs ) are a health problem in clinical care .
BACKGROUND	Several options can be employed as adjuvant to standard treatment .
OBJECTIVE	We have aimed to analyze the effect of standard ulcer care alone with high-frequency ultrasound ( HFU ) and MIST ultrasound therapy on VLUs .
METHODS	Ninety patients with VLUs were assigned into the standard treatment , HFU and MIST ultrasound groups .
METHODS	All groups received the standard wound care .
METHODS	In the ultrasound groups , HFU and MIST ultrasound therapy was administered to wounds 3 times per week until the wound healed .
METHODS	Time of complete wound healing was recorded .
METHODS	Wound size , pain , and edema were assessed at baseline and after 2 and 4 months .
METHODS	Also , patients were instructed to contact our clinic monthly , and recurrence of VLUs was recorded for 6 months after complete wound healing .
METHODS	The data was analyzed using a Student 's t-test , ANOVA , c2 , or Fisher 's exact test .
METHODS	P < 0.05 was considered significant .
RESULTS	Mean time duration of complete wound healing in the first , second and third groups was 8.13 ( SD 1.40 ) , 6.10 ( SD 1.47 ) and 5.70 ( SD 1.57 ) months , respectively ( p < 0.0001 ) .
RESULTS	Size of ulcer , mean degree of pain and edema in ultrasound therapy was decreased after the 4-month visit in comparison to the standard-treatment group ( p = 0.01 , p < 0.0001 and p < 0.0001 , respectively ) .
RESULTS	Also , our results do n't show any significant differences between groups in the recurrence of VLUs during a 6-month follow up after complete wound healing ( p = 0.37 ) .
CONCLUSIONS	Our results in the present study show the significant effectiveness of ultrasound therapy in wound healing .
CONCLUSIONS	Differences between the two ultrasound therapy groups were not statistically significant .

###24740822
OBJECTIVE	To evaluate the efficacy and safety of intraarticular sprifermin ( recombinant human fibroblast growth factor 18 ) in the treatment of symptomatic knee osteoarthritis ( OA ) .
METHODS	The study was a randomized , double-blind , placebo-controlled , proof-of-concept trial .
METHODS	Intraarticular sprifermin was evaluated at doses of 10 g , 30 g , and 100 g.
METHODS	The primary efficacy end point was change in central medial femorotibial compartment cartilage thickness at 6 months and 12 months as determined using quantitative magnetic resonance imaging ( qMRI ) .
METHODS	The primary safety end points were nature , incidence , and severity of local and systemic treatment-emergent adverse events ( AEs ) and acute inflammatory reactions , as well as results of laboratory assessments .
METHODS	Secondary end points included changes in total and compartment femorotibial cartilage thickness and volume as assessed by qMRI , changes in joint space width ( JSW ) seen on radiographs , and pain scores on the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) .
RESULTS	One hundred ninety-two patients were randomized and evaluated for safety , 180 completed the trial , and 168 were evaluated for the primary efficacy end point .
RESULTS	We found no statistically significant dose response in change in central medial femorotibial compartment cartilage thickness .
RESULTS	Sprifermin was associated with statistically significant , dose-dependent reductions in loss of total and lateral femorotibial cartilage thickness and volume and in JSW narrowing in the lateral femorotibial compartment .
RESULTS	All groups had improved WOMAC pain scores , with statistically significantly less improvement at 12 months in patients receiving the 100-g dose of sprifermin as compared with those receiving placebo .
RESULTS	There was no significant difference in serious AEs , treatment-emergent AEs , or acute inflammatory reactions between sprifermin and placebo groups .
CONCLUSIONS	No statistically significant relationship between treatment group and reduction in central medial femorotibial compartment cartilage thickness was observed ; however , prespecified structural secondary end points showed statistically significant dose-dependent reductions after sprifermin treatment .
CONCLUSIONS	Sprifermin was not associated with any local or systemic safety concerns .

###24722260
BACKGROUND	The 2-adrenergic agonist dexmedetomidine is a sedative and can be used as an adjunct to anesthetics .
BACKGROUND	Our primary goal was thus to determine the extent to which dexmedetomidine reduces the requirement for propofol and remifentanil .
METHODS	This double-blinded , randomized study ( NCT00921284 ) used an automated dual closed-loop administration to maintain the Bispectral Index between 40 and 60 .
METHODS	Sixty-6 ASA physical status I and II patients were given either dexmedetomidine ( 1 g/kg over 10 minutes followed by a continuous infusion of 0.5 g/kg/h throughout surgery ) or comparable volumes of saline as a placebo .
METHODS	Propofol and remifentanil requirements were compared using nonparametric tests and expressed as medians ( interquartile ranges ) .
RESULTS	Twenty-eight patients in each group completed the study .
RESULTS	Patients given dexmedetomidine required less propofol ( 1.0 [ 0.7-1 .3 ] vs 1.3 [ 1.0-1 .7 ] mg/kg , P = 0.002 ) and remifentanil ( 1.2 [ 1.0-1 .4 ] vs 1.6 [ 1.1-2 .8 ] g/kg , P = 0.02 ) for anesthetic induction .
RESULTS	The propofol dosage required for anesthetic maintenance was 29 % ( with a 95 % confidence interval , 18-40 ) lower in patients given dexmedetomidine ( 2.2 [ 1.5-3 .0 ] vs 3.1 [ 2.4-4 .5 ] mg/kg/h , P = 0.005 ) , whereas the remifentanil dosage was not significantly different ( 0.16 [ 0.09-0 .17 ] vs 0.14 [ 0.13-0 .21 ] g/kg/h with P = 0.3 ) .
RESULTS	The incidence of adverse events , including hemodynamic instability and delayed recovery , was comparable with and without dexmedetomidine .
RESULTS	The first postoperative request for morphine analgesia was delayed in patients given dexmedetomidine ( median fourth hour vs first hour , P = 0.008 ) .
CONCLUSIONS	Dexmedetomidine administration significantly reduced the requirement for both propofol and remifentanil during anesthetic induction and reduced propofol use during maintenance of anesthesia .
CONCLUSIONS	Dexmedetomidine also delayed postoperative analgesic use .
CONCLUSIONS	Dexmedetomidine is a useful adjuvant that reduces anesthetic requirement and provides postoperative analgesia .

###24943283
BACKGROUND	Few randomised controlled trials ( RCTs ) of interventions for the treatment of adolescent obesity have taken place outside the western world .
BACKGROUND	This RCT tested whether a simple ` good practice ' intervention for the treatment of adolescent obesity would have a greater impact on weight status and other outcomes than a referral to primary care ( control ) in adolescents in Kuwait City .
METHODS	We report on an assessor-blinded RCT of a treatment intervention in 82 obese 10 - to 14-year-olds ( mean age 12.4 , SD 1.2 years ) , randomised to a good practice treatment or primary care control group over 6 months .
METHODS	The good practice intervention was intended as relatively low intensity ( 6 hours contact over 24 weeks , group-based ) , aiming to change sedentary behaviour , physical activity , and diet .
METHODS	The primary outcome was a change in body mass index ( BMI ) Z score ; other outcomes were changes in waist circumference and blood pressure .
RESULTS	The retention of subjects to follow up was acceptable ( n = 31 from the intervention group , and n = 32 from the control group ) , but engagement with both the intervention and control treatment was poor .
RESULTS	Treatment had no significant effect on BMI Z score relative to control , and no other significant benefits to intervention were observed .
CONCLUSIONS	The trial was feasible , but highlights the need to engage obese adolescents and their families in the interventions being trialled .
CONCLUSIONS	The trial should inform the development of future adolescent obesity treatment trials in the Gulf States with the incorporation of qualitative assessment in future intervention trials .
BACKGROUND	RCT Registered as National Adolescent Treatment Trial for Obesity in Kuwait ( NATTO ) : http://www.controlled-trials.com/ISRCTN37457227 , 1 December 2009 .

###24556807
OBJECTIVE	Reflex cough is a defensive response generated in the brainstem in response to chemical and mechanical stimulation of the airways .
OBJECTIVE	However , converging evidence shows that reflex cough is also influenced by central neural control processes .
OBJECTIVE	In this study , we investigate whether reflex cough can be modulated by attentional focus on either external stimuli or internal cough-related stimuli .
METHODS	Healthy volunteers ( N = 24 ; seven men ; age range , 18-25 years ) completed four blocks of citric acid-induced cough challenges while , simultaneously , auditory stimuli were presented .
METHODS	Within each block , four concentrations were administered ( 30 , 100 , 300 and 1,000 mM , randomized ) .
METHODS	During two subsequent blocks , participants focused their attention externally ( counting tones ) .
METHODS	During the other two blocks , participants focused their attention internally ( counting coughs ) .
METHODS	The order of attentional focus was counterbalanced across participants .
METHODS	Ratings of the urge to cough were collected after each challenge .
METHODS	Cough frequency was determined by audio recording .
RESULTS	Cough frequency was higher when participants focused their attention internally vs externally ( P < .05 ) .
RESULTS	Also urge to cough was greater during internal vs external focus ( P < .05 ) , but the effect was smaller in later blocks of trials .
CONCLUSIONS	Reflex cough can be modulated by attentional focus .
CONCLUSIONS	Internally focused attention may be a mechanism involved in excessive ( idiopathic ) cough , while an external focus may be introduced as part of treatments targeting excessive cough .

###25179689
OBJECTIVE	Subcutaneous APF530 provides controlled sustained release of granisetron to prevent acute ( 0-24 h ) and delayed ( 24-120 h ) chemotherapy-induced nausea and vomiting ( CINV ) .
OBJECTIVE	This randomized , double-blind phase 3 trial compared APF530 and palonosetron in preventing acute and delayed CINV after moderately ( MEC ) or highly emetogenic chemotherapy ( HEC ) .
METHODS	Patients receiving single-day MEC or HEC received single-dose APF530 250 or 500 mg subcutaneously ( SC ) ( granisetron 5 or 10 mg ) or intravenous palonosetron 0.25 mg .
METHODS	Primary objectives were to establish APF530 noninferiority to palonosetron for preventing acute CINV following MEC or HEC and delayed CINV following MEC and to determine APF530 superiority to palonosetron for preventing delayed CINV following HEC .
METHODS	The primary efficacy end point was complete response ( CR [ using CI difference for APF530-palonosetron ] ) .
METHODS	A lower confidence bound greater than -15 % indicated noninferiority .
RESULTS	In the modified intent-to-treat population ( MEC = 634 ; HEC = 707 ) , both APF530 doses were noninferior to palonosetron in preventing acute CINV after MEC ( CRs 74.8 % [ -9.8 , 9.3 ] and 76.9 % [ -7.5 , 11.4 ] , respectively , vs. 75.0 % palonosetron ) and after HEC ( CRs 77.7 % [ -11.5 , 5.5 ] and 81.3 % [ -7.7 , 8.7 ] , respectively , vs. 80.7 % palonosetron ) .
RESULTS	APF530 500 mg was noninferior to palonosetron in preventing delayed CINV after MEC ( CR 58.5 % [ -9.5 , 12.1 ] vs. 57.2 % palonosetron ) but not superior in preventing delayed CINV after HEC .
RESULTS	Adverse events were generally mild and unrelated to treatment , the most common ( excluding injection-site reactions ) being constipation .
CONCLUSIONS	A single subcutaneous APF530 injection offers a convenient alternative to palonosetron for preventing acute and delayed CINV after MEC or HEC .

###24810873
BACKGROUND	Patients with psychiatric illness have increased somatic morbidity and increased mortality .
BACKGROUND	Knowledge of how to integrate the prevention and care of somatic illness into the treatment of psychiatric patients is required .
BACKGROUND	The aims of this study were to investigate whether an intervention programme to improve physical health is effective .
METHODS	An extension of the European Network for Promoting the Health of Residents in Psychiatric and Social Care Institutions ( HELPS ) project further developed as a 12-month controlled cluster-randomized intervention study in the Danish centre .
METHODS	Waist circumference was a proxy of unhealthy body fat in view of the increased risk of cardiovascular diseases and type 2 diabetes .
RESULTS	Waist circumference was 108 cm for men and 108 cm for women .
RESULTS	Controlled for cluster randomization , sex , age , and body fat , the intervention group showed a small , but not significant , reduction in waist circumference , while participants in the control group showed a significant increase in waist circumference .
CONCLUSIONS	The intervention had a positive effect on the physical health of the patients measured by a reduction in the increase of waist circumference .

###24532651
BACKGROUND	In resource-constrained settings of developing countries , promotion of community-based health interventions through community health workers ( CHWs ) is an important strategy to improve child health .
BACKGROUND	However , there are concerns about the sustainability of such programmes owing to the high rate of CHW attrition .
BACKGROUND	This study examined factors influencing retention of volunteer CHWs in a cluster randomised trial on community management of under-5 fever in a rural Ghanaian district .
METHODS	Data were obtained from structured interviews ( n = 520 ) and focus group discussions ( n = 5 ) with CHWs .
METHODS	Factors influencing CHWs ' decisions to remain or leave the programme were analysed using a probit model , and focus group discussion results were used to elucidate the findings .
RESULTS	The attrition rate among CHWs was 21.2 % .
RESULTS	Attrition was comparatively higher in younger age groups ( 25.9 % in 15-25 years group , 18.2 % in 26-45 years group and 16.5 % in 46 years group ) .
RESULTS	Approval of a CHW by the community ( p < 0.001 ) and the CHW 's immediate family ( p < 0.05 ) were significant in influencing the probability of remaining in the programme .
RESULTS	Motivation for retention was related to the desire to serve their communities as well as humanitarian and religious reasons .
CONCLUSIONS	The relatively moderate rate of attrition could be attributed to the high level of community involvement in the selection process as well as other aspects of the intervention leading to high community approval and support .
CONCLUSIONS	Attention for these aspects could help improve CHW retention in community-based health interventions in Ghana , and the lessons could be applied to countries within similar settings .

###24473459
OBJECTIVE	Short-term studies have suggested beneficial effects of a Palaeolithic-type diet ( PD ) on body weight and metabolic balance .
OBJECTIVE	We now report the long-term effects of a PD on anthropometric measurements and metabolic balance in obese postmenopausal women , in comparison with a diet according to the Nordic Nutrition Recommendations ( NNR ) .
METHODS	Seventy obese postmenopausal women ( mean age 60 years , body mass index 33 kg/m ( 2 ) ) were assigned to an ad libitum PD or NNR diet in a 2-year randomized controlled trial .
METHODS	The primary outcome was change in fat mass as measured by dual-energy X-ray absorptiometry .
RESULTS	Both groups significantly decreased total fat mass at 6 months ( -6.5 and-2 .6 kg ) and 24 months ( -4.6 and-2 .9 kg ) , with a more pronounced fat loss in the PD group at 6 months ( P < 0.001 ) but not at 24 months ( P = 0.095 ) .
RESULTS	Waist circumference and sagittal diameter also decreased in both the groups , with a more pronounced decrease in the PD group at 6 months ( -11.1 vs-5 .8 cm , P = 0.001 and-3 .7 vs-2 .0 cm , P < 0.001 , respectively ) .
RESULTS	Triglyceride levels decreased significantly more at 6 and 24 months in the PD group than in the NNR group ( P < 0.001 and P = 0.004 ) .
RESULTS	Nitrogen excretion did not differ between the groups .
CONCLUSIONS	A PD has greater beneficial effects vs an NNR diet regarding fat mass , abdominal obesity and triglyceride levels in obese postmenopausal women ; effects not sustained for anthropometric measurements at 24 months .
CONCLUSIONS	Adherence to protein intake was poor in the PD group .
CONCLUSIONS	The long-term consequences of these changes remain to be studied .

###25982143
OBJECTIVE	To investigate whether an infancy-onset , low saturated fat-oriented dietary intervention influences serum adiponectin concentration in adolescents , and to study the association of adiponectin with subclinical markers of vascular health , and cardio-metabolic risk factors .
METHODS	The longitudinal , randomized Special Turku Coronary Risk Factor Intervention Project aimed to modify child 's dietary fat quality replacing saturated fat with unsaturated fat .
METHODS	Serum adiponectin ( n = 521 ) along with weight , height , high-density lipoprotein cholesterol , C-reactive protein ( CRP ) , triglycerides , and insulin were measured at age 15 years .
METHODS	Adiposity was assessed using body mass index , waist circumference , and abdominal fat thickness measured with ultrasound .
METHODS	Metabolic syndrome was defined according to International Diabetes Foundation criteria .
METHODS	Vascular ultrasound measures including carotid intima-media thickness ( IMT ) were assessed .
RESULTS	Adiponectin concentrations were similar in the intervention and control groups ( P = .16 ) .
RESULTS	Adiponectin associated with carotid IMT ( r = -0.13 , P = .005 ) , high-density lipoprotein cholesterol ( r = 0.18 , P < .0001 ) , triglycerides ( r = -0.16 , P = .0004 ) , CRP ( r = -0.10 , P = .02 ) , insulin ( r = -0.14 , P = .002 ) , and adiposity ( r = -0.18 -0.24 , P .0001 ) .
RESULTS	When adjusted for adiposity indices , the association with carotid IMT was only marginally diluted ( P = .03 -.06 ) , but the associations with insulin and CRP became nonsignificant .
RESULTS	Adolescents with adiponectin median had 4-fold risk of metabolic syndrome than peers with adiponectin > median ( CI 1.8-10 .2 , P = .0001 ) .
CONCLUSIONS	In healthy adolescents , low serum adiponectin is related with carotid IMT and metabolic syndrome .
CONCLUSIONS	We found no evidence that repeated low saturated fat-oriented dietary counseling would influence serum adiponectin in adolescence .
BACKGROUND	Registered with ClinicalTrials.gov : NCT00223600 .

###24976394
BACKGROUND	Alcohol dependence is common in bipolar disorder ( BPD ) and associated with treatment nonadherence , violence , and hospitalization .
BACKGROUND	Quetiapine is a standard treatment for BPD .
BACKGROUND	We previously reported improvement in depressive symptoms , but not alcohol use , with quetiapine in BPD and alcohol dependence .
BACKGROUND	However , mean alcohol use was low and a larger effect size on alcohol-related measures was observed in those with higher levels of alcohol consumption .
BACKGROUND	In this study , efficacy of quetiapine in patients with BPD and alcohol dependence was examined in patients with higher mean baseline alcohol use than in the prior study .
METHODS	Ninety outpatients with bipolar I or II disorders , depressed or mixed mood state , and current alcohol dependence were randomized to 12 weeks of sustained release quetiapine ( to 600 mg/d ) add-on therapy or placebo .
METHODS	Drinking was quantified using the Timeline Follow Back method .
METHODS	Additional assessment tools included the Hamilton Rating Scale for Depression , Inventory of Depressive Symptomatology-Self-Report , Young Mania Rating Scale , Penn Alcohol Craving Scale , liver enzymes , and side effects .
METHODS	Alcohol use and mood were analyzed using a declining-effects random-regression model .
RESULTS	Baseline and demographic characteristics in the 2 groups were similar .
RESULTS	No significant between-group differences were observed on the primary outcome measure of drinks per day or other alcohol-related or mood measures ( p > 0.05 ) .
RESULTS	Overall side effect burden , glucose , and cholesterol were similar in the 2 groups .
RESULTS	However , a significant weight increase was observed with quetiapine at week 6 ( +2.9 lbs [ SE 1.4 ] quetiapine vs. -2.0 lbs [ SE 1.4 ] , p = 0.03 ) , but not at week 12 .
RESULTS	Scores on the Barnes Akathisia Scale increased significantly more ( p = 0.04 ) with quetiapine ( +0.40 [ SE 0.3 ] ) than placebo ( -0.52 [ SE 0.3 ] ) at week 6 but not week 12 .
RESULTS	Retention ( survival ) in the study was similar in the groups .
CONCLUSIONS	Findings suggest that quetiapine does not reduce alcohol consumption in patients with BPD and alcohol dependence .

###24622016
OBJECTIVE	To assess the longitudinal curative effect and improvement of subjective symptoms by using intratympanic injection of Budesonide ( BUD ) for otitis media with effusion ( OME ) patients older than 12 years and adults .
METHODS	A single-blind , randomized , parallel-controlled prospective study .
METHODS	Hospital , outpatient .
METHODS	Ninety patients ( 112 ears ) who were diagnosed as having OME were recruited and then randomized to BUD , dexamethasone ( DEX ) , and sodium chloride ( NS ) groups , the latter two served as controls .
METHODS	The randomly allocated patients received intratympanic injection of BUD ( 0.5 mg/1 ml ) , DEX ( 2 mg/1 ml ) , or 0.9 % NS solution ( 1 ml ) once a week .
METHODS	Survival analysis was applied to compare the longitudinal curative effects among the 3 groups .
METHODS	Meanwhile , the 6 main subjective symptoms were scored by 10-point visual scale , and physician 's evaluations were preformed during treatment and follow-up .
RESULTS	After adjustment for course of disease , volume , and characters of effusion , the relative risk ( RR ) of BUD is 0.139 ( 95 % CI , 0.054-0 .358 ) when compared with NS .
RESULTS	Survival curve demonstrated that the rank of longitudinal therapeutic efficacy was BUD , DEX , and NS ( p < 0.05 ) .
RESULTS	Both BUD and DEX showed improvements in subjective symptoms and quality of life compared with NS ( p < 0.05 ) .
RESULTS	In the aspect of improving the symptom of stuffy ear , BUD showed advantage over both DEX and NS .
RESULTS	During and after treatment , no serious complications or sequelae were observed .
CONCLUSIONS	Intratympanic injection with BUD for OME patients showed advantages in improving long-term therapeutic efficacy , it was a safe and effective intervention for adolescents and adults with OME .

###25226108
OBJECTIVE	To determine the nutrition risk status and factors associated with nutrition risk among older adults enrolled in the Brief Risk Identification Geriatric Health Tool ( BRIGHT Trial ) .
METHODS	A cluster randomised controlled trial .
METHODS	Three main centres in New Zealand .
METHODS	A total of 3,893 older adults were recruited from 60 general practices in three of the District Health Board ( DHB ) regions aged 75 years and older ( or 65 years and older if Mori ) .
METHODS	Nutrition risk was assessed using the Australian Nutrition Screening Initiative ( ANSI ) .
METHODS	Validated questionnaires were used to establish quality of life ( WHOQOL-BREF ) , physical function ( the Nottingham Extended Activities of Daily Living ) and depressive symptoms ( 15 item Geriatric Depression Scale ) .
METHODS	Demographic , standard of living and health data were established .
RESULTS	Sixty two percent of participants were identified to be at moderate or high nutrition risk .
RESULTS	The mean ANSI score was 4.9 ( range 0-21 , maximum 29 ) .
RESULTS	Factors which independently predicted moderate or high nutrition risk were female gender , being Mori and other ethnicities versus European , not being married , taking multiple medications , having more depressive symptoms , cardiovascular disease and diabetes .
RESULTS	Protective factors independently related to low nutrition risk were living with others , higher physical and social health related QOL and higher functional status .
RESULTS	WHOQOL environmental and psychological factors were not associated with nutrition risk when other predictive factors were taken into account .
CONCLUSIONS	Nearly two thirds of participants were identified to be at higher nutrition risk .
CONCLUSIONS	Women , living alone , taking multiple medications , with depressive symptoms , cardiovascular disease and ndiabetes were factors associated with higher nutrition risk .
CONCLUSIONS	Those at low nutrition risk had a better functional status and physical and social health related QOL .

###25665498
BACKGROUND	Computer-tailored physical activity ( PA ) interventions delivered through the Internet represent a promising and appealing method to promote PA at a population level .
BACKGROUND	However , personalized advice is mostly provided based on subjectively measured PA , which is not very accurate and might result in the delivery of advice that is not credible or effective .
BACKGROUND	Therefore , an innovative computer-tailored PA advice was developed , based on objectively pedometer-measured PA. .
OBJECTIVE	The study aim was to evaluate the effectiveness of a computer-tailored , pedometer-based PA intervention in working adults .
METHODS	Participants ( 18 years ) were recruited between May and December 2012 from eight Flemish workplaces .
METHODS	These workplaces were allocated randomly to an intervention or control group .
METHODS	Intervention group participants ( n = 137 ) received ( 1 ) a booklet with information on how to increase their steps , ( 2 ) a non-blinded pedometer , and ( 3 ) an Internet link to request computer-tailored step advice .
METHODS	Control group participants ( n = 137 ) did not receive any of the intervention components .
METHODS	Self-reported and pedometer-based PA were assessed at baseline ( T0 ) , and 1 month ( T1 ) and 3 months ( T2 ) months post baseline .
METHODS	Repeated measures analyses of covariance were used to examine intervention effects for both the total sample and the at-risk sample ( ie , adults not reaching 10,000 steps a day at baseline ) .
RESULTS	The recruitment process resulted in 274 respondents ( response rate of 15.1 % ) who agreed to participate , of whom 190 ( 69.3 % ) belonged to the at-risk sample .
RESULTS	Between T0 and T1 ( 1-month post baseline ) , significant intervention effects were found for participants ' daily step counts in both the total sample ( P = .004 ) and the at-risk sample ( P = .001 ) .
RESULTS	In the at-risk sample , the intervention effects showed a daily step count increase of 1056 steps in the intervention group , compared to a decrease of 258 steps in the control group .
RESULTS	Comparison of participants ' self-reported PA revealed a significant intervention effect for time spent walking in the at-risk sample ( P = .02 ) .
RESULTS	Intervention effects were still significant 3 months post baseline for participants ' daily step counts in both the total sample ( P = .03 ) and the at-risk sample ( P = .02 ) ; however , self-reported PA differences were no longer significant .
CONCLUSIONS	A computer-tailored , pedometer-based PA intervention was effective in increasing both pedometer-based and self-reported PA levels , mainly in the at-risk participants .
CONCLUSIONS	However , more effort should be devoted to recruit and retain participants in order to improve the public health impact of the intervention .
BACKGROUND	ClinicalTrials.gov : NCT02080585 ; https://clinicaltrials.gov/ct2/show/NCT02080585 ( Archived by WebCite at http://www.webcitation.org/6VvQnRQSy ) .

###24220616
BACKGROUND	In a multicenter , randomized , open-label phase III study , patients 65 years with newly diagnosed AML received decitabine 20 mg/m ( 2 ) once daily for 5 days every 4 weeks ( n = 242 ) or treatment choice ( supportive care or cytarabine 20 mg/m ( 2 ) once daily for 10 days every 4 weeks ; n = 243 ) .
BACKGROUND	Decitabine use demonstrated greater response rates ( P = .001 ) and OS data favored decitabine .
METHODS	In a post hoc sensitivity analysis of mature data of patients in the intent-to-treat population ( N = 485 ) , OS at 3 , 6 , 12 , 18 , and 24 months after randomization was estimated for each arm using Kaplan-Meier methods .
METHODS	Age , cytogenetic risk , and Eastern Cooperative Oncology Group performance status were used as stratification factors in the Cox regression model to estimate the hazard ratio .
RESULTS	A survival advantage was seen with decitabine at each cutoff time point ; hazard ratios for OS for decitabine vs. treatment choice were 0.83 , 0.71 , 0.83 , 0.80 , and 0.79 at 3 , 6 , 12 , 18 , and 24 months , respectively .
RESULTS	A trend toward improved OS with decitabine was observed at fixed time points over 2 years .
CONCLUSIONS	Decitabine should be considered as a treatment option for older patients with AML and poor prognostic risk factors .

###24785921
BACKGROUND	The aim of this study was to compare the time to initial alignment and extraction space closure using conventional brackets and active and passive self-ligating brackets .
METHODS	One hundred adolescent patients 11 to 18 years of age undergoing maxillary and mandibular fixed appliance therapy after the extraction of 4 premolars were randomized with stratification of 2 age ranges ( 11-14 and 15-18 years ) and 3 maxillomandibular plane angles ( high , medium , and low ) with an allocation ratio of 1:2:2 .
METHODS	Restrictions were applied using a block size of 10 .
METHODS	Allocation was to 1 of 3 treatment groups : conventional brackets , active self-ligating , or passive self-ligating brackets .
METHODS	All subjects were treated with the same archwire sequence and space-closing mechanics in a district general hospital setting .
METHODS	The trial was a 3-arm parallel design .
METHODS	Labial-segment alignment and space closure were measured on study models taken every 12 weeks throughout treatment .
METHODS	All measurements were made by 1 operator who was blinded to bracket type .
METHODS	The patients and other operators were not blinded to bracket type during treatment .
RESULTS	Ninety-eight patients were followed to completion of treatment ( conventional , n = 20 ; active self-ligating brackets , n = 37 ; passive self-ligating brackets , n = 41 ) .
RESULTS	The data were analyzed using linear mixed models and demonstrated a significant effect of bracket type on the time to initial alignment ( P = 0.001 ) , which was shorter with the conventional brackets than either of the self-ligating brackets .
RESULTS	Sidak 's adjustment showed no significant difference in effect size ( the difference in average response in millimeters ) between the active and passive self-ligating brackets ( the results are presented as effect size , 95 % confidence intervals , probabilities , and intraclass correlation coefficients ) ( -0.42 [ -1.32 , 0.48 ] , 0.600 , 0.15 ) , but the conventional bracket was significantly different from both of these ( -1.98 [ -3.19 , -0.76 ] , 0.001 , 0.15 ; and -1.56 [ -2.79 , -0.32 ] , 0.001 , 0.15 ) .
RESULTS	There was no statistically significant difference between any of the 3 bracket types with respect to space closure .
RESULTS	Space-closure times were shorter in the mandible , except for the Damon 3MX bracket ( Ormco , Orange , Calif ) , where active and total space-closure times were shorter in the maxilla .
RESULTS	No adverse events were recorded in the trial .
CONCLUSIONS	Time to initial alignment was significantly shorter for the conventional bracket than for either the active or passive self-ligating brackets .
CONCLUSIONS	There was no statistically significant difference in passive , active , or total space-closure times among the 3 brackets under investigation .

###24374068
BACKGROUND	To date there has been no research investigating moderators of response to micronutrient treatment of mental illness , specifically baseline nutrient levels .
METHODS	We conducted analyses of data from a randomized placebo-controlled trial ( RCT ) of 80 adults ( 16years ) with Attention-Deficit/Hyperactivity Disorder ( ADHD ) , whereby participants were treated acutely ( 8weeks ) with micronutrients or placebo followed by an open-label ( OL ) phase of 8weeks whereby all participants received micronutrients .
METHODS	To ensure that all participants had been exposed to the micronutrients for 8weeks , only those 64 who had adhered to the treatment protocol and completed 8weeks on nutrients were included in the data analysis : 34 from the group that had been randomized to the micronutrient arm , and 30 from the group that had been randomized to the placebo group and hence had only received nutrients in the OL phase .
METHODS	Six outcomes were examined : change in ADHD symptoms ( self/clinician ) , ADHD responder , Clinical Global Impression-Improvement ( CGI-I ) , change in mood , and change in Global Assessment of Functioning ( GAF ) .
METHODS	Demographic , developmental and psychiatric history , current clinical characteristics , and baseline nutrient levels were all considered as putative predictors .
RESULTS	There were significant changes in all outcome variables after 8weeks exposure to the micronutrients .
RESULTS	Among the nutrients recorded at baseline , substantial deficiencies ( 27 % ) were only observed for vitamin D. However , other than an association showing that higher iron at baseline was correlated with higher baseline depression scores , baseline nutrient levels were not correlated with baseline psychiatric variables/current clinical characteristics .
RESULTS	Regression analyses revealed that higher baseline ferritin and lower baseline copper and vitamin D levels were associated with a better response to treatment for some but not all outcomes .
RESULTS	None of the other nutrient levels was found to be associated with outcome , including zinc , vitamin B12 , iron , and folate .
RESULTS	There were no childhood risk factors , demographic variables or clinical correlates that contraindicated micronutrient treatment ; more severe symptoms at baseline and greater number of developmental risk factors predicted greater treatment response .
CONCLUSIONS	Further research looking at nutrients more broadly is required to confirm these initial observations about ferritin , vitamin D and copper ; however , the results suggest that serum nutrient levels have limited value for identifying who will respond to treatment .

###24277401
OBJECTIVE	To explore the feasibility and safety of enteral nutrition in preoperative bowel preparation for rectal cancer patients undergoing radical operation .
METHODS	Sixty rectal cancer patients undergoing selective low anterior resection were randomized into the trial group ( n = 30 ) and the control group ( n = 30 ) .
METHODS	Patients in the trial group received clean liquid integral protein diet for 3 days before operation without mechanical bowel preparation .
METHODS	Patients in the control group received traditional diet and mechanical bowel preparation .
METHODS	The intraoperative and postoperative clinical data , the quality of bowel preparation , postoperative complications , and nutritional parameters were compared between the two groups .
RESULTS	There were no significant differences in clinicopathological characteristics between the two groups before operation .
RESULTS	The operative time , blood loss , quality of bowel preparation as well as postoperative hospital stay were not significantly different ( all P > 0.05 ) .
RESULTS	While the time to first flatus [ ( 2.530.91 ) d vs. ( 3.030.68 ) d ] and semi-liquid diet intake [ ( 3.950.83 ) d vs. ( 4.521.14 ) d ] were significantly shorter in the trial group as compared with the control group ( all P < 0.05 ) .
RESULTS	There were no death and no significant difference in postoperative complications [ 16.7 % ( 5/30 ) vs. 20.0 % ( 6/30 ) , P > 0.05 ] .
RESULTS	The levels of postoperative total protein , albumin , and prealbumin decreased significantly .
RESULTS	Meanwhile , the levels of postoperative albumin [ ( 36.22.5 ) g/L vs. ( 33.52.6 ) g/L , P < 0.01 ] and prealbumin [ ( 325.428.2 ) mg/L vs. ( 302.534.2 ) mg/L , P < 0.01 ] in the trial group were significantly higher than those in the control group .
CONCLUSIONS	Preoperative enteral nutrition can replace the mechanical bowel preparation with better efficacy , and improve the postoperative nutritional status without increasing surgical risk in rectal cancer patients undergoing radical operation .

###25194850
BACKGROUND	In resource-poor areas of China and India , the cardiovascular disease burden is high , but availability of and access to quality healthcare is limited .
BACKGROUND	Establishing a management scheme that utilizes the local infrastructure and builds healthcare capacity is essential for cardiovascular disease prevention and management .
BACKGROUND	The study aims to develop , implement , and evaluate the feasibility and effectiveness of a simplified , evidence-based cardiovascular management program delivered by community healthcare workers in resource-constrained areas in Tibet , China and Haryana , India .
METHODS	This yearlong cluster-randomized controlled trial will be conducted in 20 villages in Tibet and 20 villages in Haryana .
METHODS	Randomization of villages to usual care or intervention will be stratified by country .
METHODS	High cardiovascular disease risk individuals ( aged 40 years or older , history of heart disease , stroke , diabetes , or measured systolic blood pressure of 160 mmHg or higher ) will be screened at baseline .
METHODS	Community health workers in the intervention villages will be trained to manage and follow up high-risk patients on a monthly basis following a simplified ' 2 +2 ' intervention model involving two lifestyle recommendations and the appropriate prescription of two medications .
METHODS	A customized electronic decision support system based on the intervention strategy will be developed to assist the community health workers with patient management .
METHODS	Baseline and follow-up surveys will be conducted in a standardized fashion in all villages .
METHODS	The primary outcome will be the net difference between-group in the proportion of high-risk patients taking antihypertensive medication pre - and post-intervention .
METHODS	Secondary outcomes will include the proportion of patients taking aspirin and changes in blood pressure .
METHODS	Process and economic evaluations will also be conducted .
CONCLUSIONS	To our knowledge , this will be the first study to evaluate the effect of a simplified management program delivered by community health workers with the help of electronic decision support system on improving the health of high cardiovascular disease risk patients .
CONCLUSIONS	If effective , this intervention strategy can serve as a model that can be implemented , where applicable , in rural China , India , and other resource-constrained areas .
BACKGROUND	The trial was registered in the clinicaltrials.gov database on 30 December , 2011 and the registration number is NCT01503814 .

###25443593
OBJECTIVE	The purpose of this study was to evaluate the effectiveness of the academic asthma education and counseling Staying Healthy-Asthma Responsible and Prepared ( SHARP ) program on fostering psychosocial acceptance of asthma .
METHODS	This was a phase III , two-group , cluster-randomized , single-blinded , longitudinal study .
METHODS	Students from grades 4 and 5 ( N = 205 ) with asthma and their caregivers completed surveys at pre-intervention and at 1 - , 12 - , and 24-months post-intervention .
METHODS	Analysis involved multilevel modeling .
RESULTS	All students demonstrated significant improvement in aspects of acceptance ; students in SHARP demonstrated significant improvement in openness to sharing and connectedness with teachers over students in the control condition .
CONCLUSIONS	The SHARP program offers a well-tested , effective program for psychosocial acceptance of asthma , which is welcomed by schools .

###25475809
OBJECTIVE	Posterior sagittal anorectoplasty ( PSARP ) has become the standard surgical treatment for males rectourethral fistula ( RUF ) at most surgical centers worldwide .
OBJECTIVE	We aimed to define the long-term bowel functional outcomes following PSARP for RUF at our institution between 1983 and 2006 , with comparison to age - and gender-matched controls .
METHODS	Patients were invited to answer a detailed , previously validated Bowel Function Score ( BFS ) questionnaire by post .
METHODS	Respondents were matched by age and gender to three controls from the general population who had answered identical questionnaires .
METHODS	Case records were reviewed retrospectively for operative details .
METHODS	Ethical approval was obtained .
METHODS	Social continence was defined as soiling or fecal accidents < 1/week and no requirement for changes of underwear or protective aids .
RESULTS	Of 34 ( 79 % ) respondents ( median age 19 ( range , 4-29 ) years ) , 74 % had voluntary bowel movements ( VBMs ) , 24 % were reliant on anterograde continence enema ( ACE ) washouts , and 1 patient had a colostomy .
RESULTS	Impairment of bowel function was significantly higher in all aspects of fecal control among patients than controls ( p < 0.001 ) .
RESULTS	A statistically significant decline in fecal accidents and soiling was observed with age ( p 0.03 ) .
RESULTS	Thirty-one percent of patients with VBMs had constipation managed with diet or laxatives ( vs 2 % of controls , p = 0.0002 ) .
RESULTS	Of patients with VBMs followed up for > 12 years ( n = 20 ) , 50 % were completely continent ( vs 73 % of controls ; p = NS ) .
RESULTS	Overall , 76 % of respondents were socially continent with or without artificial means in the form of ACE washouts .
RESULTS	By BFS score , 39 % had a good functional outcome , 27 % had a moderate outcome , 9 % had a clearly poor score and 24 % were living with an ACE .
CONCLUSIONS	Our results suggest that in the long-term , functional symptoms remain highly prevalent among patients treated for RUF with PSARP .
CONCLUSIONS	However , the majority can be expected to achieve social continence , although for some this will require intervention with ACE bowel management .
CONCLUSIONS	Approximately one third may report VBMs and complete continence .

###25600249
OBJECTIVE	To test the feasibility , acceptability and initial effectiveness of a text message-based aftercare treatment programme among alcohol outpatients .
METHODS	Clients treated for alcohol use disorders from three Swiss outpatient alcohol treatment centres were invited by their counsellors to participate in a study testing an interactive aftercare programme employing the use of text messages and personal phone calls .
METHODS	Fifty study participants were randomly assigned to either the 6-month aftercare programme ( n = 25 ) or treatment as usual ( n = 25 ) .
METHODS	The intervention consisted of ( a ) monitoring of self-selected drinking goals at regular intervals , ( b ) motivational text messages to stick to self-selected drinking goals and ( c ) proactive telephone calls from counsellors when participants neglected to stick to their drinking goals or expressed a need for support .
METHODS	Follow-up interviews were conducted 6 months after randomization .
RESULTS	Throughout the programme , participants received a total of 421 text message prompts .
RESULTS	Out of these , participants provided valid replies to 371 ( 88.1 % ) within 48 h. Out of the 25 participants in the intervention group , 11 ( 44.0 % ) sent at least one call-for-help reply .
RESULTS	Based on complete case data , at risk alcohol use at follow-up was 41.7 % in the control group and 28.6 % in the intervention group ( OR = 0.56 , 95 % CI = 0.16-1 .95 , P = 0.36 ) .
CONCLUSIONS	The interactive low-intensive aftercare programme was well accepted by the participants .
CONCLUSIONS	Testing its efficacy within an adequately powered randomized controlled trial might be reasonable .

###24565021
BACKGROUND	Weaning is typically regarded as a process of discontinuing mechanical ventilation in the daily practice of an intensive care unit ( ICU ) .
BACKGROUND	Among the ICU patients , 39 % -40 % need mechanical ventilator for sustaining their lives .
BACKGROUND	The predictive rate of successful weaning achieved only 35-60 % for decisions made by physicians .
BACKGROUND	Clinical decision support systems ( CDSSs ) are promising in enhancing diagnostic performance and improve healthcare quality in clinical setting .
BACKGROUND	To our knowledge , a prospective study has never been conducted to verify the effectiveness of the CDSS in ventilator weaning before .
BACKGROUND	In this study , the CDSS capable of predicting weaning outcome and reducing duration of ventilator support for patients has been verified .
METHODS	A total of 380 patients admitted to the respiratory care center of the hospital were randomly assigned to either control or study group .
METHODS	In the control group , patients were weaned with traditional weaning method , while in the study group , patients were weaned with CDSS monitored by physicians .
METHODS	After excluding the patients who transferred to other hospitals , refused further treatments , or expired the admission period , data of 168 and 144 patients in the study and control groups , respectively , were used for analysis .
RESULTS	The results show that a sensitivity of 87.7 % has been achieved , which is significantly higher ( p < 0.01 ) than the weaning determined by physicians ( sensitivity : 61.4 % ) .
RESULTS	Furthermore , the days using mechanical ventilator for the study group ( 38.41 3.35 ) is significantly ( p < 0.001 ) shorter than the control group ( 43.69 14.89 ) , with a decrease of 5.2 days in average , resulting in a saving of healthcare cost of NT$ 45,000 ( US$ 1,500 ) per patient in the current Taiwanese National Health Insurance setting .
CONCLUSIONS	The CDSS is demonstrated to be effective in identifying the earliest time of ventilator weaning for patients to resume and sustain spontaneous breathing , thereby avoiding unnecessary prolonged ventilator use and decreasing healthcare cost .

###25319676
BACKGROUND	Subjective tinnitus is the perception of sound in the absence of a corresponding external sound for which there is no known medical etiology .
BACKGROUND	For a minority of individuals with tinnitus , the condition impacts their ability to lead a normal lifestyle and is severely debilitating .
BACKGROUND	There is no known cure for tinnitus , so current therapy focuses on reducing the effect of tinnitus on the patient 's quality of life .
BACKGROUND	Tinnitus retraining therapy ( TRT ) uses nonpsychiatric tinnitus-specific educational counseling and sound therapy in a habituation-based protocol to reduce the patient 's tinnitus-evoked negative reaction to , and awareness of , the tinnitus , with the ultimate goal of reducing the tinnitus impact on the patient 's quality of life .
BACKGROUND	Some studies support the efficacy of TRT , but no trial to date has compared TRT with the current standard of care or evaluated the separate contributions of TRT counseling and sound therapy .
BACKGROUND	The Tinnitus Retraining Therapy Trial ( TRTT ) is a randomized , double-blind , placebo-controlled , multicenter trial for individuals with intolerable tinnitus .
METHODS	The TRTT is enrolling active-duty and retired military personnel and their dependents with functionally adequate hearing sensitivity and severe tinnitus at US Air Force , Navy , and Army medical centers .
METHODS	Eligible study participants are randomized to TRT , partial TRT , or standard care to determine the efficacy of TRT and its components ( TRT counseling and sound therapy ) .
METHODS	The primary outcome is change in score on the Tinnitus Questionnaire assessed longitudinally between baseline and follow-up ( 3 , 6 , 12 , and 18 months following treatment ) .
METHODS	Secondary outcomes include subscale score changes in the Tinnitus Questionnaire , overall and subscale score changes in the Tinnitus Functional Index and Tinnitus Handicap Inventory , and change in the visual analog scale of the TRT Interview Form .
METHODS	Audiological outcomes include tinnitus pitch and loudness match and measures of loudness discomfort levels .
METHODS	The incidence of depression as a safety measure is assessed at each visit using the Beck Depression Inventory Fast Screen .
BACKGROUND	Clinicaltrials.gov NCT01177137 .

###24463231
BACKGROUND	Treadmill training with partial body weight support has been suggested as a useful strategy for gait rehabilitation after stroke .
OBJECTIVE	This prospective , randomized , controlled study of gait training tested the feasibility and potential efficacy of using a robotic-assisted gait device , Lokomat , for treadmill training with partial body weight support in subjects with chronic hemiplegia ; the device was also compared with conventional home exercise .
METHODS	Twenty-two male ambulatory ischemic or hemorrhagic induced stroke patients with chronic hemiplegia lasting at least 12 months were enrolled in this prospective study .
METHODS	The patients were assigned to either the Lokomat group or the conventional exercise group .
METHODS	The Lokomat group underwent active robotic training for ten sessions ( five sessions per week for two weeks ) .
METHODS	Each session lasted 30 minutes .
METHODS	If a patient missed three consecutive training sessions , he was removed from the study .
METHODS	The Timed Up and Go Test is used to assess mobility and requires both static and dynamic balance .
METHODS	The 10-m Timed Walking Speed Test is designed to determine the patient 's overground walking speed .
METHODS	The Mini-Mental State Examination and Hospital Anxiety and Depression Scale were used for mental and psychological evaluation ; the Functional Ambulation Categories was used to assess ambulatory status .
RESULTS	Within each eight-week interval , the patients undergoing the Lokomat training demonstrated significantly greater improvement on the Timed Up and Go Test and 10-m Timed Walking Speed Test than those undergoing conventional training .
CONCLUSIONS	Despite the small number of patients in the study , the present data suggests that the robotic-assisted device , Lokomat , provides innovative possibilities for gait training in chronic hemiplegia rehabilitation by training at higher intensity levels for longer durations than traditional home exercise .

###25081280
BACKGROUND	Patients with cardiac arrhythmias are generally instructed to avoid caffeine intake .
BACKGROUND	A comprehensive evaluation of the electrophysiological effects of caffeine on atrial and ventricular tissues in humans has not previously been performed .
RESULTS	Eighty patients ( 31men , mean age 4914years ) with symptomatic supraventricular tachycardia ( SVT ) undergoing an electrophysiologic study ( EPS ) prior to catheter ablation were randomized to receive oral caffeine or placebo .
RESULTS	Caffeine at a dosage of 5mg/kg ( moderate intake ) or placebo tablets were administered orally at a mean time of 5713 minutes prior to the EPS .
RESULTS	The median ( IQR ) caffeine level in patients receiving caffeine was 7.4 g/mL ( 4.7-8 .7 ) , as compared with 0.15 ( 0.00-0 .61 ) in patients receiving placebo , P < 0.0001 .
RESULTS	Caffeine was associated with a significant increase in resting systolic and diastolic blood pressures as compared with placebo , while the resting heart rate was not significantly different between both groups .
RESULTS	Caffeine was not associated with significant effects on the effective refractory period of the atrium or ventricle , as well as on AV node conduction .
RESULTS	SVT was induced in all but 3 patients ; there was no significant difference between groups receiving placebo or caffeine on SVT inducibility or the cycle length of induced tachycardias .
CONCLUSIONS	Caffeine , at moderate intake , was associated with significant increases in systolic and diastolic blood pressures , but had no evidence of a significant effect on cardiac conduction and refractoriness .
CONCLUSIONS	Furthermore , no effect of caffeine on SVT induction or more rapid rates of induced tachycardias was found .

###24345758
OBJECTIVE	Bipolar disorder often co-occurs with anxiety disorders .
OBJECTIVE	Evidence suggests that second-generation antipsychotics ( SGAs ) may be useful in treating both conditions .
OBJECTIVE	This study examined the efficacy of ziprasidone in the treatment of these disorders .
METHODS	This 3-site , randomized , double-blind , placebo-controlled , parallel group , 8-week trial of ziprasidone monotherapy examined 49 subjects with bipolar disorder and lifetime panic disorder ( with or without agoraphobia ) or generalized anxiety disorder ( GAD ) experiencing moderately severe anxiety symptoms at entrance into the study .
METHODS	Both bipolar disorder and anxiety diagnoses were based on DSM-IV-TR criteria .
METHODS	Patients were screened and randomized from June 25 , 2010 , through August 23 , 2011 .
METHODS	Primary outcome measures were the Clinical Global Impressions-21 Anxiety Scale ( CGI-21 Anxiety ) and the Sheehan Disability Scale ( SDS ) , with secondary measures monitoring anxiety and mood symptoms .
RESULTS	Last-observation-carried-forward analyses demonstrated that patients in the ziprasidone group did not improve significantly more than those in the placebo group on the CGI-21 Anxiety ( F1 = 0.34 ; P = .564 ) or SDS ( F1 = 0.26 ; P = .611 ) .
RESULTS	Secondary analysis using hierarchical linear modeling found similar results ( CGI-21 Anxiety : F1 = 1.82 ; P = .178 ; and SDS : F1 = 0.70 ; P = .408 ) .
RESULTS	Regardless of group , time in the study was associated with significant decrease in anxiety ( F1 = 11.08 ; P = .001 ) and total disability ( F1 = 26.16 ; P < .001 ) .
RESULTS	Patients in the ziprasidone group showed a greater increase in abnormal involuntary movement , and 81.8 % ( n = 9 ) of the subjects who withdrew from the study due to adverse events , serious adverse events , or side effects were in the ziprasidone group .
CONCLUSIONS	Results suggest that ziprasidone monotherapy was not associated with a clinically significant improvement in anxiety symptoms or improved function for patients with bipolar disorder , lifetime panic disorder or GAD , and concurrent moderately severe anxiety symptoms , and it was associated with a more negative side-effect profile relative to placebo .
BACKGROUND	ClinicalTrials.gov identifier : NCT01172652 .

###25163405
BACKGROUND	Epinastine hydrochloride is a selective histamine H1 receptor antagonist that also inhibits IgE receptor-mediated histamine release from mast cells .
OBJECTIVE	To show the superiority of epinastine 0.05 % ophthalmic solution ( epinastine ) to placebo ophthalmic solution ( placebo ) and noninferiority to olopatadine 0.1 % ophthalmic solution ( olopatadine ) for cedar pollen antigen-induced ocular itching and conjunctival hyperemia .
METHODS	The study was conducted in ophthalmologically asymptomatic adult volunteers with seasonal allergic conjunctivitis using a conjunctival allergen challenge test .
METHODS	Subjects were randomized into 3 groups ( n = 87 ) to evaluate superiority to placebo ( visits 4 to 6 ) and 2 groups ( n = 86 ) to evaluate noninferiority to olopatadine ( visit 7 ) .
METHODS	At each visit , a single administration of the study medication was instilled at 15 minutes ( visit 4 ) , 4 hours ( visit 5 ) , 8 hours ( visit 6 ) , and 4 hours ( visit 7 ) before the conjunctival allergen challenge test .
METHODS	Ocular itching and conjunctival hyperemia of allergic conjunctivitis were assessed after the conjunctival allergen challenge test .
RESULTS	For the primary end point , epinastine showed superiority to placebo for the inhibition of ocular itching and conjunctival hyperemia induced at 4 hours after the dose ( equivalent to 4-times-daily dosing ) .
RESULTS	For the secondary end points , epinastine significantly inhibited itching and conjunctival hyperemia induced at 15 minutes and 8 hours after the dose ( equivalent to 2-times-daily dosing ) compared with placebo .
RESULTS	In addition , epinastine demonstrated noninferiority to olopatadine for ocular itching and conjunctival hyperemia .
RESULTS	No adverse drug reactions or serious adverse events were reported throughout the study , indicating that epinastine has a good safety profile .
CONCLUSIONS	Epinastine is effective and safe for the treatment of allergic conjunctivitis .
BACKGROUND	Clinicaltrials.gov identifier NCT01363700 .

###25225010
BACKGROUND	Sarcopenia is a defining feature of cancer cachexia associated with physical decline , poor quality of life and poor prognosis .
BACKGROUND	Thus , maintaining muscle mass is an important aim of cachexia treatment .
BACKGROUND	Many patients at risk for developing cachexia or with cachexia experience side effects of chemotherapy that might aggravate the development of cachexia .
BACKGROUND	However , achieving tumor control might reverse the catabolic processes causing cachexia .
BACKGROUND	There is limited knowledge about muscle mass changes during chemotherapy or whether changes in muscle mass are associated with response to chemotherapy .
METHODS	In this pilot study , patients with advanced non-small cell lung cancer ( NSCLC ) receiving three courses of palliative chemotherapy were analyzed .
METHODS	Muscle mass was measured as skeletal muscle cross sectional area ( SMCA ) at the level of the third lumbar vertebrae using CT images taken before and after chemotherapy .
RESULTS	In total 35 patients , 48 % women , mean age 67 years ( range 56-86 ) , participated ; 83 % had stage IV disease and 71 % were sarcopenic at baseline .
RESULTS	Mean reduction in SMCA from pre - to post-chemotherapy was 4.6 cm2 ( CI 95 % -7.3 -- 1.9 ; p < 0.002 ) , corresponding to a 1.4 kg loss of whole body muscle mass .
RESULTS	Sixteen patients remained stable or gained SMCA .
RESULTS	Of these , 14 ( 56 % ) responded to chemotherapy , while two progressed ( p = 0.071 ) .
RESULTS	Maintaining or gaining SMCA resulted in longer median overall survival ( loss : 5.8 months , stable/gain : 10.7 months ; p = 0.073 ) .
RESULTS	Stage of disease ( p = 0.003 ) , treatment regimen ( p = 0.023 ) , response to chemotherapy ( p = 0.007 ) and SMCA change ( p = 0.040 ) , but not sarcopenia at baseline , were significant prognostic factors in the multivariate survival analyses .
CONCLUSIONS	Almost half of the patients had stable or increased muscle mass during chemotherapy without receiving any cachexia treatment .
CONCLUSIONS	Nearly all of these patients responded to the chemotherapy .
CONCLUSIONS	Increase in muscle mass , but not sarcopenia at baseline , was a significant prognostic factor .

###24683674
BACKGROUND	The effectiveness of commonly suggested public health interventions to control childhood iron-deficiency anemia has been low .
OBJECTIVE	To determine whether iron provided in Sprinkles daily or in a higher dose once weekly affected hemoglobin , serum ferritin levels , and serum transferrin receptor levels , and to determine whether there were differences in the effects of the two regimens .
METHODS	In this cluster-randomized , community-based trial conducted in rural areas of Bangladesh , 136 children aged 12 to 24 months with mild to moderate anemia ( hemoglobin 70-109 g/L ) were randomly allocated to receive Sprinkles daily ( 12.5 mg of elemental iron , n = 79 ) or once weekly ( 30 mg of elemental iron , n = 73 ) for 8 weeks .
METHODS	Hemoglobin , serum ferritin , and serum transferrin receptor were assessed at the start and end of the intervention .
RESULTS	In both groups , there were significant increases in hemoglobin and serum ferritin and a significant decrease in serum transferrin receptor ( p < .01 ) .
RESULTS	There were no significant differences between the groups in the increases in hemoglobin ( 16.1 + / - 13.2 g/L for the group receiving Sprinkles daily and 12.3 + / - 13.3 g/L for the group receiving Sprinkles once weekly ) and serum ferritin ( 10.6 and 5.7 microg/L , respectively ) .
RESULTS	The decrease in serum transferrin receptor also did not significantly differ between the groups ( median , -2.5 and -1.8 mg/L , respectively ) .
RESULTS	The prevalence rates of iron-deficiency anemia , depleted iron stores , and tissue iron deficiency decreased significantly within each group ( p < .01 ) , with no significant differences between the groups .
CONCLUSIONS	Home fortification of complementary foods with Sprinkles given either daily or once weekly improved iron-deficiency anemia and iron status among young children .

###25189359
BACKGROUND	Refinements in stent design affecting strut thickness , surface polymer , and drug release have improved clinical outcomes of drug-eluting stents .
BACKGROUND	We aimed to compare the safety and efficacy of a novel , ultrathin strut cobalt-chromium stent releasing sirolimus from a biodegradable polymer with a thin strut durable polymer everolimus-eluting stent .
METHODS	We did a randomised , single-blind , non-inferiority trial with minimum exclusion criteria at nine hospitals in Switzerland .
METHODS	We randomly assigned ( 1:1 ) patients aged 18 years or older with chronic stable coronary artery disease or acute coronary syndromes undergoing percutaneous coronary intervention to treatment with biodegradable polymer sirolimus-eluting stents or durable polymer everolimus-eluting stents .
METHODS	Randomisation was via a central web-based system and stratified by centre and presence of ST segment elevation myocardial infarction .
METHODS	Patients and outcome assessors were masked to treatment allocation , but treating physicians were not .
METHODS	The primary endpoint , target lesion failure , was a composite of cardiac death , target vessel myocardial infarction , and clinically-indicated target lesion revascularisation at 12 months .
METHODS	A margin of 35 % was defined for non-inferiority of the biodegradable polymer sirolimus-eluting stent compared with the durable polymer everolimus-eluting stent .
METHODS	Analysis was by intention to treat .
METHODS	The trial is registered with ClinicalTrials.gov , number NCT01443104 .
RESULTS	Between Feb 24 , 2012 , and May 22 , 2013 , we randomly assigned 2119 patients with 3139 lesions to treatment with sirolimus-eluting stents ( 1063 patients , 1594 lesions ) or everolimus-eluting stents ( 1056 patients , 1545 lesions ) .
RESULTS	407 ( 19 % ) patients presented with ST-segment elevation myocardial infarction .
RESULTS	Target lesion failure with biodegradable polymer sirolimus-eluting stents ( 69 cases ; 65 % ) was non-inferior to durable polymer everolimus-eluting stents ( 70 cases ; 66 % ) at 12 months ( absolute risk difference -014 % , upper limit of one-sided 95 % CI 197 % , p for non-inferiority < 00004 ) .
RESULTS	No significant differences were noted in rates of definite stent thrombosis ( 9 [ 09 % ] vs 4 [ 04 % ] , rate ratio [ RR ] 226 , 95 % CI 070-733 , p = 016 ) .
RESULTS	In pre-specified stratified analyses of the primary endpoint , biodegradable polymer sirolimus-eluting stents were associated with improved outcome compared with durable polymer everolimus-eluting stents in the subgroup of patients with ST-segment elevation myocardial infarction ( 7 [ 33 % ] vs 17 [ 87 % ] , RR 038 , 95 % CI 016-091 , p = 0024 , p for interaction = 0014 ) .
CONCLUSIONS	In a patient population with minimum exclusion criteria and high adherence to dual antiplatelet therapy , biodegradable polymer sirolimus-eluting stents were non-inferior to durable polymer everolimus-eluting stents for the combined safety and efficacy outcome target lesion failure at 12 months .
CONCLUSIONS	The noted benefit in the subgroup of patients with ST-segment elevation myocardial infarction needs further study .
BACKGROUND	Clinical Trials Unit , University of Bern , and Biotronik , Blach , Switzerland .

###25033925
BACKGROUND	Besides the classical role of vitamin D on calcium and bone homeostasis , vitamin D deficiency has recently been identified as a contributing factor in the onset of insulin resistance in type 2 diabetes mellitus .
BACKGROUND	However , it is uncertain whether vitamin D deficiency and poor glycaemic control are causally interrelated or that they constitute two independent features of type 2 diabetes mellitus .
BACKGROUND	There are limited clinical trials carried out which measured the effect of vitamin D supplementation on glycaemic control.The objective of this study is to investigate the effect of vitamin D supplementation on glycaemic control and quality of life in patients with type 2 diabetes mellitus .
METHODS	In a randomised double-blind placebo-controlled trial conducted in five general practices in the Netherlands three hundred patients with type 2 diabetes mellitus treated with lifestyle advises or metformin or sulphonylurea-derivatives are randomised to receive either placebo or 50,000 IU Vitamin D3 at monthly intervals .
METHODS	The primary outcome measure is the change in glycated haemoglobin level between baseline and six months .
METHODS	Secondary outcome measures include blood pressure , anthropometric parameters , lipid profile , insulin resistance , quality of life , advanced glycation end products and safety profiles .
METHODS	Quality of life will be measured by The Short Form ( SF-36 ) Health Survey questionnaire .
METHODS	Advanced glycation end products are measured by an AGE-reader .
CONCLUSIONS	This trial will be the first study exploring the effect of vitamin D supplementation on both glycaemic control and quality of life in patients with type 2 diabetes mellitus .
CONCLUSIONS	Our findings will contribute to the knowledge of the relationship between vitamin D status and insulin resistance in patients with type 2 diabetes mellitus .
BACKGROUND	The Netherlands trial register : NTR3154 .

###26067559
OBJECTIVE	While performing a lateral nasal wall osteotomy during a rhinoplasty , an intentional fracture is produced and the fractured segments are medialized to narrow a wide nasal base .
OBJECTIVE	The purpose of this study was to investigate the effect of size , shape , and extension of the external nasal splint on the osteotomy , brow lines , and long-term results of rhinoplasty .
METHODS	The authors designed a randomized prospective clinical trial .
METHODS	The study population was composed entirely of patients who were voluntarily referred to the authors ' department from May 2012 to May 2013 .
METHODS	They were randomly divided into 2 equal groups .
METHODS	The primary predictor variable was splint type .
METHODS	For group 1 , the external splint was extended beyond the osteotomy lines laterally and covered the overlying skin of the frontal process of the maxillary bone .
METHODS	For group 2 , the external splint was trimmed above the osteotomy lines .
METHODS	The primary outcome variables were the levels of satisfaction with the dorsal esthetic lines , brow lines , and distinct osteotomy lines at 12 months after the operation .
METHODS	Demographic variables were gender and age .
METHODS	Mann-Whitney U test , ( 2 ) test , and t test were used to analyze the data .
METHODS	Results with a P value less than .05 were considered significant .
RESULTS	Forty healthy patients ( American Society of Anesthesiologists status I and II ; 18 men and 22 women ; age range , 19 to 41 yr ; mean , 31.4 yr ) were selected .
RESULTS	Although the level of satisfaction with the dorsal esthetic lines was higher in group 2 , it was not significantly different from group 1 ( P > .05 ) .
RESULTS	The levels of satisfaction with the brow lines and the distinct osteotomy lines were significantly higher in group 2 ( P < .05 ) .
CONCLUSIONS	The results of this study showed that when a nasal splint is extended beyond the frontal process of the maxilla rather than the base of the nasal bones , positioning of the bones and long-term results are unpredictable .

###24302269
OBJECTIVE	The complex relationship between left atrial ( LA ) structure and function , electrical burden of atrial fibrillation ( AF ) and stroke risk is not well understood .
OBJECTIVE	We aimed to describe LA structure and function in AF .
RESULTS	Left atrial structure and function was assessed in 971 subjects enrolled in the echocardiographic substudy of ENGAGE AF-TIMI 48 .
RESULTS	Left atrial size , emptying fraction ( LAEF ) , and contractile function were compared across AF types ( paroxysmal , persistent , or permanent ) and CHADS2 scores as an estimate of stroke risk .
RESULTS	The majority of AF patients ( 55 % ) had both LA enlargement and reduced LAEF , with an inverse relationship between LA size and LAEF ( R = -0.57 , P < 0.001 ) .
RESULTS	With an increasing electrical burden of AF and higher CHADS2 scores , LA size increased and LAEF declined .
RESULTS	Moreover , 19 % of AF subjects had impaired LAEF despite normal LA size , and LA contractile dysfunction was present even among the subset of AF subjects in sinus rhythm at the time of echocardiography .
CONCLUSIONS	In a contemporary AF population , LA structure and function were increasingly abnormal with a greater electrical burden of AF and higher stroke risk estimated by the CHADS2 score .
CONCLUSIONS	Moreover , LA dysfunction was present despite normal LA size and sinus rhythm , suggesting that the assessment of LA function may add important incremental information in the evaluation of AF patients .
BACKGROUND	http://www.clinicaltrials.gov; ID = NCT00781391 .

###25560547
BACKGROUND	Mammography is considered the best imaging technique for breast cancer screening , and the radiographer plays an important role in its performance .
BACKGROUND	Therefore , continuing education is critical to improving the performance of these professionals and thus providing better health care services .
OBJECTIVE	Our goal was to develop an e-learning course on breast imaging for radiographers , assessing its efficacy , effectiveness , and user satisfaction .
METHODS	A stratified randomized controlled trial was performed with radiographers and radiology students who already had mammography training , using pre - and post-knowledge tests , and satisfaction questionnaires .
METHODS	The primary outcome was the improvement in test results ( percentage of correct answers ) , using intention-to-treat and per-protocol analysis .
RESULTS	A total of 54 participants were assigned to the intervention ( 20 students plus 34 radiographers ) with 53 controls ( 19 +34 ) .
RESULTS	The intervention was completed by 40 participants ( 11 +29 ) , with 4 ( 2 +2 ) discontinued interventions , and 10 ( 7 +3 ) lost to follow-up .
RESULTS	Differences in the primary outcome were found between intervention and control : 21 versus 4 percentage points ( pp ) , P < .001 .
RESULTS	Stratified analysis showed effect in radiographers ( 23 pp vs 4 pp ; P = .004 ) but was unclear in students ( 18 pp vs 5 pp ; P = .098 ) .
RESULTS	Nonetheless , differences in students ' posttest results were found ( 88 % vs 63 % ; P = .003 ) , which were absent in pretest ( 63 % vs 63 % ; P = .106 ) .
RESULTS	The per-protocol analysis showed a higher effect ( 26 pp vs 2 pp ; P < .001 ) , both in students ( 25 pp vs 3 pp ; P = .004 ) and radiographers ( 27 pp vs 2 pp ; P < .001 ) .
RESULTS	Overall , 85 % were satisfied with the course , and 88 % considered it successful .
CONCLUSIONS	This e-learning course is effective , especially for radiographers , which highlights the need for continuing education .

###25554993
BACKGROUND	The Internet is used to deliver information on many psychiatric disorders such as bipolar disorder .
BACKGROUND	This paper reports on the results of a 12-months randomised controlled trial , which examined the efficacy of an Internet-based preventive program for bipolar disorder , adjunctive to usual pharmacological management .
METHODS	Participants were recruited by completing an online screening questionnaire accessed through the Black Dog Institute and Sentiens websites based in Australia .
METHODS	The treatment was predominantly psycho-educational with cognitive behavioral therapy optional elements .
METHODS	The attention control treatment comprised directing subjects to a variety of websites focused on ` healthy living ' .
METHODS	Time to recurrence was determined using Kaplan-Meier survival analysis .
METHODS	The main outcome measures were recurrence as defined by : ( i ) depressive and/or hypomanic symptomatology and functional capacity ( using Beck Depression Inventory , Internal State Scale and Sheehan Disability Scale ) and ( ii ) hospitalization .
RESULTS	Two-hundred-and-thirty-three subjects were randomized to the active or control treatment groups .
RESULTS	There were no significant differences between the active and control treatment groups on any of the definitions of recurrence .
CONCLUSIONS	Reliance on an online self-report tool to confirm diagnosis and hospitalization rates may have potentially allowed for inclusion of individuals with other diagnoses such as borderline personality disorder .
CONCLUSIONS	The ` attention control ' treatment may have included more ` active ' components than intended .
CONCLUSIONS	This is the first report examining the efficacy of a randomized controlled web-based psychological intervention in a large sample of subjects with bipolar disorder .
CONCLUSIONS	The potential reasons for failing to demonstrate a significant difference compared to the active control are discussed .

###24603562
BACKGROUND	Early enteral fat supplementation and fish oil ( FO ) stimulates post-resection intestinal adaptation in rats and increases fat absorption in premature infants with bowel resection and an enterostomy .
OBJECTIVE	To test the hypothesis that early fat supplement and FO increases post-resection protein absorption , intestinal RNA , protein without decreasing intestinal arachidonic acid ( AA ) in premature infants with an enterostomy .
METHODS	36 premature infants ( < 2 months old ) with an enterostomy after surgical treatment for necrotizing enterocolitis or spontaneous intestinal perforation who tolerated enteral feeding at 20 ml/kg/day were randomized to usual care ( control , n = 18 ) or early supplementing enteral Microlipid ( ML ) and FO ( treatment , n = 18 ) .
METHODS	Intralipid was decreased as the dose of enteral fat was increased .
METHODS	Daily weight , ostomy output and nutritional intake were recorded .
METHODS	Weekly 24-hour ostomy effluent was collected to measure fecal protein .
METHODS	Protein absorption was calculated by subtracting fecal protein from dietary protein .
METHODS	Tissue samples from the functional stoma and the nonfunctional distal diverted end were collected during bowel reanastomosis to measure RNA , protein , and fatty acid ( FA ) profile .
RESULTS	Compared to controls , the treatment group had higher protein absorption ( g/kg/day ) and intestinal RNA and protein ( g/mg tissue ) proximal to the ostomy .
RESULTS	The two groups had similar FA profiles except that the treatment group had higher n-3 eicosapentaenoic acid ( EPA , g/mg tissue ) proximal to the ostomy .
CONCLUSIONS	Early supplementation of enteral ML and FO to premature infants with an enterostomy increased dietary protein absorption , intestinal RNA , protein and n-3 EPA content without altering other FA content .

###24468996
BACKGROUND	We studied the effect of maternal HIV-exposure and timing of antiretroviral treatment ( ART ) in HIV-infected infants on antibody responses to combined diphtheria-toxoid-tetanus-toxoid-whole cell pertussis and Haemophilus influenzae type b conjugate vaccine ( HibCV ) and monovalent hepatitis B vaccine ( HBV ) .
METHODS	HIV-uninfected infants born to HIV-infected ( HEU ) or HIV-uninfected ( HUU ) mothers were enrolled in parallel with HIV-infected children with CD4 25 % , who were randomized to initiate ART immediately upon confirmation of HIV-infection ( ART-Immed ) or when clinically and/or immunologically indicated ( ART-Def ) .
METHODS	Infants received three doses of diphtheria-toxoid-tetanus-toxoid - wP-HibC/HBV at 7.3 , 11.4 and 15.4 weeks of age .
METHODS	Antibody to diphtheria-toxoid , tetanus-toxoid , pertussis toxin , filamentous hemagglutinin ( FHA ) and hepatitis B surface antigen ( HBsAg ) were measured by Luminex multiplex-immunoassay and polyribosyl-ribitol phosphate ( PRP ) antibodies by standard ELISA and bactericidal assay .
RESULTS	Prevaccination antibody geometric mean concentrations ( GMCs ) were higher in HUU than HEU infants for tetanus-toxoid , but lower for HBsAg , diphtheria-toxoid and FHA .
RESULTS	Postvaccination GMCs and proportion with seroprotective antibody levels or sero-conversion rates were similar between HUU and HEU infants for all vaccines .
RESULTS	Postvaccination GMCs were higher in HUU for tetanus-toxoid , diphtheria-toxoid , HBsAg and FHA than ART-Immed infants ; and for tetanus-toxoid , HBsAg and pertussis-toxoid than ART-Def infants .
RESULTS	Nevertheless , there was no difference in proportion of HUU and HIV-infected infants who developed sero-protective vaccine-specific antibody levels postvaccination .
RESULTS	The timing of ART initiation generally did not affect immune responses to vaccines between HIV-infected groups .
CONCLUSIONS	Vaccination with DTwP-HibCV/HBV of HEU and HIV-infected infants initiated on early-ART confers similar immunity compared with HUU children .

###25465111
BACKGROUND	Previous analyses of the International Subarachnoid Aneurysm Trial ( ISAT ) cohort have reported on the risks of recurrent subarachnoid haemorrhage and death or dependency for a minimum of 5 years and up to a maximum of 14 years after treatment of a ruptured intracranial aneurysm with either neurosurgical clipping or endovascular coiling .
BACKGROUND	At 1 year there was a 7 % absolute and a 24 % relative risk reduction of death and dependency in the coiling group compared with the clipping group , but the medium-term results showed the increased need for re-treatment of the target aneurysm in the patients given coiling .
BACKGROUND	We report the long-term follow-up of patients in this UK cohort .
METHODS	In ISAT , patients were randomly allocated to either neurosurgical clipping or endovascular coiling after a subarachnoid haemorrhage , assuming treatment equipoise , between Sept 12 , 1994 , and May 1 , 2002 .
METHODS	We followed up 1644 patients in 22 UK neurosurgical centres for death and clinical outcomes for 100-185 years .
METHODS	We assessed dependency as self-reported modified Rankin scale score obtained through yearly questionnaires .
METHODS	Data for recurrent aneurysms and rebleeding events were collected from questionnaires and from hospital and general practitioner records .
METHODS	The Office for National Statistics supplied data on deaths .
METHODS	This study is registered , number ISRCTN49866681 .
RESULTS	At 10 years , 674 ( 83 % ) of 809 patients allocated endovascular coiling and 657 ( 79 % ) of 835 patients allocated neurosurgical clipping were alive ( odds ratio [ OR ] 135 , 95 % CI 106-173 ) .
RESULTS	Of 1003 individuals who returned a questionnaire at 10 years , 435 ( 82 % ) patients treated with endovascular coiling and 370 ( 78 % ) patients treated with neurosurgical clipping were independent ( modified Rankin scale score 0-2 ; OR 125 ; 95 % CI 092-171 ) .
RESULTS	Patients in the endovascular treatment group were more likely to be alive and independent at 10 years than were patients in the neurosurgery group ( OR 134 , 95 % CI 107-167 ) .
RESULTS	33 patients had a recurrent subarachnoid haemorrhage more than 1 year after their initial haemorrhage ( 17 from the target aneurysm ) .
CONCLUSIONS	Although rates of increased dependency alone did not differ between groups , the probability of death or dependency was significantly greater in the neurosurgical group than in the endovascular group .
CONCLUSIONS	Rebleeding was more likely after endovascular coiling than after neurosurgical clipping , but the risk was small and the probability of disability-free survival was significantly greater in the endovascular group than in the neurosurgical group at 10 years .
BACKGROUND	UK Medical Research Council .

###25310825
BACKGROUND	HIV and other STIs are major public health concerns for women , and risky sexual behaviors increase the risk of transmission .
BACKGROUND	Risky sexual behaviors include sexual abdication , that is , willingness to let a partner decide how far to go sexually .
BACKGROUND	Alcohol intoxication is a risk factor for risky sexual behavior , and the Inhibition Conflict Model of Alcohol Myopia may help explain this relationship .
BACKGROUND	This model suggests that in order for intoxication to influence behavior there must be high conflict , meaning the strength of the instigatory cues and inhibitory cues are both high .
BACKGROUND	Recent research indicates that the degree to which cues are experienced as high in instigation or inhibition is subject to individual difference factors .
BACKGROUND	One individual difference factor associated with alcohol-related sexual risk taking is child sexual abuse ( CSA ) history .
METHODS	The current study examined the influence of acute alcohol intoxication , CSA , and inhibition conflict on sexual abdication with 131 women ( mean age 25 ) randomized into a 2 ( alcohol , control ) 2 ( high conflict , low conflict ) experimental design .
RESULTS	Regression analyses yielded a significant 3-way interaction , F ( 1,122 ) = 8.15 , R ( 2 ) = .14 , p < .01 .
RESULTS	When there was high conflict , intoxicated CSA women were more likely to abdicate than sober CSA women , however , sober CSA women were less likely to abdicate than sober NSA women , when there was low conflict , CSA history and alcohol intoxication had no influence on abdication .
CONCLUSIONS	These results may help explain the association between alcohol and risky sexual decision making among women with CSA .

###25443423
OBJECTIVE	To test the efficacy of a Stress Management and Resiliency Training ( SMART ) program for decreasing stress and anxiety and improving resilience and quality of life among Department of Radiology physicians .
METHODS	The study was approved by the institutional review board .
METHODS	A total of 26 Department of Radiology physicians were randomized in a single-blind trial to either the SMART program or a wait-list control arm for 12 weeks .
METHODS	The program involved a single 90-min group session in the SMART training with two follow-up phone calls .
METHODS	Primary outcomes measured at baseline and week 12 included the Perceived Stress Scale , Linear Analog Self-Assessment Scale , Mindful Attention Awareness Scale , and Connor-Davidson Resilience Scale .
RESULTS	A total of 22 physicians completed the study .
RESULTS	A statistically significant improvement in perceived stress , anxiety , quality of life , and mindfulness at 12 weeks was observed in the study arm compared to the wait-list control arm ; resilience also improved in the active arm , but the changes were not statistically significant when compared to the control arm .
CONCLUSIONS	A single session to decrease stress among radiologists using the SMART program is feasible .
CONCLUSIONS	Furthermore , the intervention afforded statistically significant and clinically meaningful improvement in anxiety , stress , quality of life , and mindful attention .
CONCLUSIONS	Further studies including larger sample size and longer follow-up are warranted .

###25011439
BACKGROUND	Colorectal cancer ( CRC ) is the second most common malignancy in Europe and a leading cause of cancer-related death .
BACKGROUND	Almost 50 % of patients with CRC develop liver metastases , which heralds a poor prognosis unless metastases can be downsized to surgical resection or ablation .
BACKGROUND	The FOXFIRE trial examines the hypothesis that combining radiosensitising chemotherapy ( OxMdG : oxaliplatin , 5-fluorouracil and folic acid ) with Selective Internal Radiation Therapy ( SIRT or radioembolisation ) using yttrium-90 resin microspheres ( SIR-Spheres ; Sirtex Medical Limited , North Sydney , Australia ) as a first-line treatment for liver-dominant metastatic CRC will improve clinical outcomes when compared to OxMdG chemotherapy alone .
METHODS	FOXFIRE is an open-label , multicentre , randomised controlled trial of OxMdG with or without the addition of SIRT ( 1:1 randomisation ) .
METHODS	Eligible adult patients have histologically confirmed colorectal adenocarcinoma , liver metastases measurable on computed tomography scan and untreatable by either surgical resection or local ablation , and they may have limited extra-hepatic disease , defined as 5 nodules in the lung and/or one other metastatic site which is amenable to future definitive treatment .
METHODS	Eligible patients may have received adjuvant chemotherapy following resection of the primary tumour , but are not permitted to have previously received chemotherapy for metastatic disease , and must have a life expectancy of 3 months and a WHO performance status of 0-1 .
METHODS	The primary outcome is overall survival .
METHODS	Secondary outcomes include progression free survival ( PFS ) , liver-specific PFS , patient-reported outcomes , safety , response rate , resection rate and cost-effectiveness .
METHODS	FOXFIRE shares a combined statistical analysis plan with an international sister trial called SIRFLOX .
CONCLUSIONS	This trial is establishing a network of SIRT centres and ` feeder ' chemotherapy-only centres to standardise the delivery of SIRT across the whole of the UK and to provide greater equity of access to this highly specialised liver-directed therapy .
CONCLUSIONS	The FOXFIRE trial will establish the potential role of adding SIRT to first-line chemotherapy for unresectable liver metastatic colorectal cancer , and the impact on current treatment paradigms for metastatic CRC .
BACKGROUND	ISRCTN83867919 .

###25932849
OBJECTIVE	To compare adipose tissue concentration among obese women receiving 2 g compared with 3 g of precesarean cefazolin prophylaxis .
METHODS	This was a double-blind randomized controlled trial of women with singleton gestations and body mass indexes ( BMIs ) of 30 or greater at their first prenatal visit undergoing cesarean delivery at term .
METHODS	Women were randomly allocated , stratified by BMI , to receive 2 g or 3 g of cefazolin .
METHODS	Subcutaneous adipose tissue was harvested twice : before ( opening ) fascial incision and after ( closing ) fascial closure .
METHODS	The primary outcome was opening adipose tissue cefazolin concentration , measured by high-pressure liquid chromatography .
RESULTS	From April 2013 to July 2014 , 58 women were enrolled , 57 included in the analysis : 28 in the 2-g group and 29 in the 3-g group .
RESULTS	Baseline characteristics were similar between groups .
RESULTS	Median opening adipose tissue concentration was similar between the 2-g and 3-g groups ( 9.4 [ interquartile range 5.1-13 .4 ] compared with 11.7 [ interquartile range 7-18 .3 ] micrograms/g , P = .12 ) .
RESULTS	The percentage of women with opening concentrations above 8 micrograms/g , the minimally inhibitory concentration of cefazolin for Staphylococcus species , was similar ( 61 % compared with 72 % , P = .35 ) .
RESULTS	All samples were above 2 micrograms/g , the minimally inhibitory concentration for Enterobacteriaceae .
RESULTS	Closing adipose tissue concentrations and stratified analyses were consistent with the overall analysis .
CONCLUSIONS	In obese women undergoing cesarean delivery , prophylaxis with 3 g of cefazolin did not significantly increase adipose tissue concentration .
CONCLUSIONS	Thus , our data do not support recommendations for 3-g dosing .
METHODS	I.

###24326527
OBJECTIVE	Liraglutide can modulate insulin secretion by directly stimulating beta cells or indirectly through weight loss and enhanced insulin sensitivity .
OBJECTIVE	Recently , we showed that liraglutide treatment in overweight individuals with prediabetes ( impaired fasting glucose and/or impaired glucose tolerance ) led to greater weight loss ( -7.7 % vs -3.9 % ) and improvement in insulin resistance compared with placebo .
OBJECTIVE	The current study evaluates the effects on beta cell function of weight loss augmented by liraglutide compared with weight loss alone .
METHODS	This was a parallel , randomised study conducted in a single academic centre .
METHODS	Both participants and study administrators were blinded to treatment assignment .
METHODS	Individuals who were 40-70 years old , overweight ( BMI 27-40 kg/m ( 2 ) ) and with prediabetes were randomised ( via a computerised system ) to receive liraglutide ( n = 35 ) or matching placebo ( n = 33 ) , and 49 participants were analysed .
METHODS	All were instructed to follow an energy-restricted diet .
METHODS	Primary outcome was insulin secretory function , which was evaluated in response to graded infusions of glucose and day-long mixed meals .
RESULTS	Liraglutide treatment ( n = 24 ) significantly ( p0 .03 ) increased the insulin secretion rate ( % mean change [ 95 % CI ] ; 21 % [ 12 , 31 ] vs -4 % [ -11 , 3 ] ) and pancreatic beta cell sensitivity to intravenous glucose ( 229 % [ 161 , 276 ] vs -0.5 % ( -15 , 14 ] ) , and decreased insulin clearance rate ( -3.5 % [ -11 , 4 ] vs 8.2 [ 0.2 , 16 ] ) as compared with placebo ( n = 25 ) .
RESULTS	The liraglutide-treated group also had significantly ( p0 .03 ) lower day-long glucose ( -8.2 % [ -11 , -6 ] vs -0.1 [ -3 , 2 ] ) and NEFA concentrations ( -14 [ -20 , -8 ] vs -2.1 [ -10 , 6 ] ) following mixed meals , whereas day-long insulin concentrations did not significantly differ as compared with placebo .
RESULTS	In a multivariate regression analysis , weight loss was associated with a decrease in insulin secretion rate and day-long glucose and insulin concentrations in the placebo group ( p0 .05 ) , but there was no association with weight loss in the liraglutide group .
RESULTS	The most common side effect of liraglutide was nausea .
CONCLUSIONS	A direct stimulatory effect on beta cell function was the predominant change in liraglutide-augmented weight loss .
CONCLUSIONS	These changes appear to be independent of weight loss .
BACKGROUND	ClinicalTrials.gov NCT01784965 FUNDING : The study was funded by the ADA .

###24848812
OBJECTIVE	The purpose of this study was to compare the performance of a 20-gauge fenestrated catheter with an 18-gauge nonfenestrated catheter for i.v. contrast infusion during MDCT .
METHODS	Two hundred five adult outpatients imaged on a dual-source 128-MDCT scanner with arterial phase body CT ( flow rates , 5.0-7 .5 mL/s ) were randomized to either an 18-gauge nonfenestrated or 20-gauge fenestrated catheter .
METHODS	After randomization , any 18-gauge nonfenestrated subjects whose veins were deemed insufficient for that catheter gauge were assigned to a third cohort for placement of a 20-gauge fenestrated catheter .
METHODS	Catheter placement success , infusion rate , contrast volume , maximum pressure , complications , and aortic enhancement levels were recorded .
RESULTS	Catheters were placed on the first attempt in 97 % ( 100/103 ) for 18-gauge nonfenestrated and 94 % ( 96/102 ) for 20-gauge fenestrated placements and in two or fewer attempts in 99 % of both groups .
RESULTS	Mean infusion rates ( 5.74 mL/s for 18-gauge nonfenestrated and 5.58 mL/s for 20-gauge fenestrated placements ) and aortic enhancement levels were not significantly different .
RESULTS	Maximum pressure was higher with 20-gauge fenestrated catheters ( mean SD , 230.5 27.6 pounds per square inch [ psi ] ) than 18-gauge nonfenestrated catheters ( mean SD 215.6 32.8 psi ) ( p = 0.002 ) .
RESULTS	One subject with an 18-gauge nonfenestrated catheter had a high-pressure alarm .
RESULTS	In the third cohort , a 20-gauge fenestrated catheter was successfully placed in two or fewer attempts in 85 % ( 28/33 ) , with one minor extravasation attributed to vein insufficiency .
CONCLUSIONS	A 20-gauge fenestrated catheter performs similarly to an 18-gauge nonfenestrated catheter with respect to i.v. contrast infusion rates and aortic enhancement levels and can be placed in most subjects whose veins are deemed insufficient for an 18-gauge catheter .

###24434302
BACKGROUND	Patient blood management is introduced as a new concept that involves the combined use of transfusion alternatives .
BACKGROUND	In elective adult total hip - or knee-replacement surgery patients , the authors conducted a large randomized study on the integrated use of erythropoietin , cell saver , and/or postoperative drain reinfusion devices ( DRAIN ) to evaluate allogeneic erythrocyte use , while applying a restrictive transfusion threshold .
BACKGROUND	Patients with a preoperative hemoglobin level greater than 13 g/dl were ineligible for erythropoietin and evaluated for the effect of autologous blood reinfusion .
METHODS	Patients were randomized between autologous reinfusion by cell saver or DRAIN or no blood salvage device .
METHODS	Primary outcomes were mean intra - and postoperative erythrocyte use and proportion of transfused patients ( transfusion rate ) .
METHODS	Secondary outcome was cost-effectiveness .
RESULTS	In 1,759 evaluated total hip - and knee-replacement surgery patients , the mean erythrocyte use was 0.19 ( SD , 0.9 ) erythrocyte units/patient in the autologous group ( n = 1,061 ) and 0.22 ( 0.9 ) erythrocyte units/patient in the control group ( n = 698 ) ( P = 0.64 ) .
RESULTS	The transfusion rate was 7.7 % in the autologous group compared with 8.3 % in the control group ( P = 0.19 ) .
RESULTS	No difference in erythrocyte use was found between cell saver and DRAIN groups .
RESULTS	Costs were increased by 298 per patient ( 95 % CI , 76 to 520 ) .
CONCLUSIONS	In patients with preoperative hemoglobin levels greater than 13 g/dl , autologous intra - and postoperative blood salvage devices were not effective as transfusion alternatives : use of these devices did not reduce erythrocyte use and increased costs .

###24586591
BACKGROUND	Patient chart review is the gold standard for detection of potential patient hazards ( i.e. medication errors or failure to follow up actionable results ) in both routine clinical care and patient safety research .
BACKGROUND	However , advanced medical students ' ability to read patient charts and to identify patient hazards is rather poor .
BACKGROUND	We therefore investigated whether it is possible to teach advanced medical students how to identify patient hazards independent of context ( i.e. cancer versus cardiac failure ) in patient charts .
METHODS	All fifth-year medical students in one semester ( n = 123 ) were randomized into two groups .
METHODS	One group ( IC ) received a patient chart review-training first and then a control-intervention and the other group ( CI ) received the control-intervention first and then the patient chart review-training .
METHODS	Before and after the teaching sessions , students reviewed different scenarios with standardized fictional patient charts containing 12 common patient hazards .
METHODS	Two blinded raters rated the students ' notes for any patient hazard addressed in the notes using a checklist .
METHODS	The students were blinded to the study question and design .
METHODS	There was no external funding and no harm for the participating students .
RESULTS	A total of 35 data sets had to be excluded because of missing data .
RESULTS	Overall , the students identified 17 % ( IQR 8-29 % ) of the patient hazards before the training and 56 % ( IQR 41-66 % ) of the patient hazards after the training .
RESULTS	At the second assessment students identified more patient hazards than at the first .
RESULTS	They identified even more in the third .
RESULTS	The effect was most pronounced after the patient chart review training ( all p < .01 ) .
CONCLUSIONS	Patient chart review exercises and problem-based patient chart review training improve students ' abilities to recognize patient hazards independent of context during patient chart review .

###25153574
OBJECTIVE	To investigate homoarginine and asymmetric dimethylarginine ( ADMA ) in controls compared to children with type 1 diabetes ( T1D ) and if homoarginine and ADMA are affected by atorvastatin .
METHODS	Homoarginine and ADMA levels of 28 T1D patients were compared to levels of 41 controls .
METHODS	In T1D patients , homoarginine and ADMA were determined at baseline , 1 year , and 2 years at daily 10 mg atorvastatin or placebo within a double-blind study .
RESULTS	At baseline , both homoarginine and ADMA were lower ( p < 0.001 ) in T1D patients compared to controls .
RESULTS	In T1D patients , homoarginine and ADMA were not influenced by atorvastatin .
RESULTS	Inverse correlations between homoarginine and HbA1c ( p < 0.001 ) and between ADMA and systolic blood pressure ( p = 0.005 ) and pulse pressure ( p = 0.003 ) were shown .
CONCLUSIONS	Homoarginine and ADMA levels are decreased and associated with cardiovascular risk factors in children with T1D without being affected by atorvastatin .

###24392550
OBJECTIVE	To evaluate the effect of note-taking skills training on the achievement motivation in learning .
METHODS	The experimental study comprised graduate students of the 2010-11 batch at Kerman 's Bahonar University and Kerman 's Medical Sciences University , Iran .
METHODS	The study sample included 110 people ; 55 in the test group , and 55 in the control group .
METHODS	They were randomly selected and replaced through the single-stage cluster sampling .
METHODS	To collect the data , a questionnaire was used .
METHODS	Pre-test was performed before the training session in two groups .
METHODS	After training course , a post-test was taken .
METHODS	For data analysis , the independent t-test , was used .
RESULTS	The average pre-test score of the test group was 182 + / - 34.15 , while for the control group it was 191 + / - 30.37 ( p < 0.089 ) .
RESULTS	After the training , the post-test showed statistically significant change .
RESULTS	The test group scored 220 + / - 20.94 against the controls who scored 195 + / - 27.26 ( p < 0.001 ) .
CONCLUSIONS	The findings showed that achievement motivation in learning increased significantly after imparting training in note-taking skills .
CONCLUSIONS	Authorities in the educational system should invest more for promotion of such skills .

###26242010
BACKGROUND	The present clinical trial was designed to investigate the effectiveness of subgingivally delivered satranidazole ( SZ ) gel as an adjunct to scaling and root planing ( SRP ) in the treatment of chronic periodontitis .
METHODS	Sixty-four subjects with probing depth ( PD ) 5 mm and who were diagnosed with type 2 diabetes were selected .
METHODS	Thirty-two subjects each were randomly assigned to SRP + placebo ( Group 1 ) and SRP + SZ ( Group 2 ) .
METHODS	The clinical outcomes evaluated were plaque index ( PI ) , gingival index ( GI ) , clinical attachment level ( CAL ) and PD at baseline , 1 month , 3-months and 6 months .
RESULTS	At 6 months , Group 2 had greater mean reduction ( 4.73 mm ) in PD as compared to Group 1 ( 2.09 mm ; p < 0.05 ) and also a greater mean CAL gain ( 3.92 mm versus 1.64 mm ; p < 0.05 ) .
CONCLUSIONS	The use of 3 % SZ gel , when used as an adjunct to non-surgical periodontal therapy in subjects with periodontitis , achieves significantly better clinical results than initial periodontal treatment alone .

###24687433
BACKGROUND	Although highly porous metals have demonstrated excellent bone ingrowth properties and so are an intriguing option for fixation in total knee arthroplasty ( TKA ) , some surgeons are skeptical about the durability of uncemented tibial fixation and the potential for soft tissues to adhere to these porous metals and perhaps cause knee stiffness or pain .
OBJECTIVE	The purpose of this study was to compare , in the context of a randomized clinical trial , a highly porous metal tibia compared with a traditional modular cemented tibia in terms of survivorship , Knee Society scores , range of motion ( ROM ) , and complications .
METHODS	From 2003 to 2006 , 397 patients ( age 67.88.7 years ; 54 % female ) were randomized to three groups : ( 1 ) traditional modular cemented tibia ; ( 2 ) cemented highly porous metal tibia ; and ( 3 ) uncemented highly porous metal tibia .
METHODS	The same posterior-stabilized femoral component and patella component were cemented in every case .
METHODS	Stratified randomization was done for surgeon , patient 's age , sex , and body mass index .
METHODS	Survivorship at 5years was compared between the groups , as were Knee Society scores , ROM , and complications .
METHODS	Radiographic assessment included alignment , radiolucency , and implant migration/loosening .
METHODS	Patients were followed until death , revision , or for a minimum of 2years ( mean , 5years ; range , 2-9years ) .
METHODS	Four patients were lost to followup before 2years .
RESULTS	Highly porous metal tibias ( both uncemented and cemented ) were no different from traditional cemented modular tibial modular components in terms of survivorship at 5years using a intention-to-treat analysis ( 96.8 % [ 1 ] ; 97.6 % [ 2 ] ; 96.7 % [ 3 ] ; p = 0.59 ) .
RESULTS	A per-protocol analysis revealed that no highly porous metal tibia was revised for aseptic loosening .
RESULTS	Highly porous metal tibias performed comparably to traditional cemented modular tibias in terms of Knee Society scores , ROM , and the frequency of complications .
CONCLUSIONS	At 5years this randomized clinical trial demonstrated that highly porous metal tibias provided comparably durable fixation and reliable pain relief and restoration of function when compared with a traditional cemented modular tibia in TKA .
METHODS	Level I , therapeutic study .
METHODS	See Guidelines for Authors for a complete description of levels of evidence .

###24480721
BACKGROUND	In The Netherlands , screening for chlamydia ( the most prevalent sexually transmitted infection worldwide ) is a relatively simple and free procedure .
BACKGROUND	Via an invitation letter sent by the public health services ( PHS ) , people are asked to visit a website to request a test kit .
BACKGROUND	They can then do a chlamydia test at home , send it anonymously to a laboratory , and , within two weeks , they can review their test results online and be treated by their general practitioner or the PHS .
BACKGROUND	Unfortunately , the participation rates are low and the process is believed to be not ( cost - ) effective .
OBJECTIVE	The objective of this study was to assess whether the low participation rate of screening for chlamydia at home , via an invitation letter asking to visit a website and request a test kit , could be improved by optimizing the invitation letter through systematically applied behavior change theories and evidence .
METHODS	The original letter and a revised letter were randomly sent out to 13,551 citizens , 16 to 29 years old , in a Dutch municipality .
METHODS	Using behavior change theories , the revised letter sought to increase motivation to conduct chlamydia screening tests .
METHODS	The revised letter was tailored to beliefs that were found in earlier studies : risk perception , advantages and disadvantages ( attitude ) , moral norm , social influence , and response - and self-efficacy .
METHODS	Revisions to the new letter also sought to avoid possible unwanted resistance caused when people feel pressured , and included prompts to trigger the desired behavior .
RESULTS	No significant differences in test package requests were found between the two letters .
RESULTS	There were also no differences between the original and revised letters in the rates of returned tests ( 11.80 % , 581/4922 vs. 11.07 % , 549/4961 ) or positive test results ( 4.8 % , 23/484 vs. 4.1 % , 19/460 ) .
RESULTS	It is evident that the new letter did not improve participation compared to the original letter .
CONCLUSIONS	It is clear that the approach of inviting the target population through a letter does not lead to higher participation rates for chlamydia screening .
CONCLUSIONS	Other approaches have to be developed and pilot tested .

###24263388
BACKGROUND	This study was designed to compare two approaches to negative-pressure wound therapy : 125-mmHg pressure with a polyurethane foam dressing and 75-mmHg pressure with a silicone-coated dressing .
METHODS	Forty patients with diabetic foot wounds , after incision and drainage or amputation for infection , were assigned randomly to negative-pressure wound therapy with 75-mmHg continuous pressure with a silicone-covered dressing ( 75-mmHg group ) or 125-mmHg with a polyurethane foam dressing ( 125-mmHg group ) for up to 4 weeks or until surgical closure .
RESULTS	There was no difference in the proportion of wounds that were closed surgically ( 75-mmHg group , 50 percent ; 125-mmHg group , 60 percent ) , wounds that demonstrated 50 percent wound area reduction ( 75-mmHg group , 65 percent ; 125-mmHg group , 80 percent ) , or wounds that demonstrated 50 percent wound volume reduction after 4 weeks of therapy ( 75-mmHg group , 95 percent ; 125-mmHg group , 90 percent ) .
CONCLUSIONS	The authors ' results suggest that there was no difference in outcomes in wounds treated with low pressure ( 75 mmHg ) with a silicone-coated interface and high pressure ( 125 mmHg ) with a polyurethane foam interface .
METHODS	Therapeutic , II .

###24557418
BACKGROUND	In the AVAGAST study , fluoropyrimidine and cisplatin plus bevacizumab did not significantly improve overall survival ( OS ) versus fluoropyrimidine and cisplatin plus placebo in patients with advanced gastric cancer .
BACKGROUND	Geographic differences in efficacy were observed in AVAGAST , but the study only included 12 Chinese patients .
BACKGROUND	AVATAR , a study similar in design to AVAGAST , was a randomized , double-blind , phase III study conducted in Chinese patients with advanced gastric cancer .
METHODS	Patients more than 18 years of age with gastric adenocarcinoma were randomized 1:1 to capecitabine-cisplatin plus either bevacizumab or placebo .
METHODS	The primary endpoint was OS ; secondary endpoints included progression-free survival ( PFS ) and safety .
RESULTS	In total , 202 patients were included ( placebo n = 102 ; bevacizumab n = 100 ) .
RESULTS	Baseline characteristics were well balanced .
RESULTS	The primary analysis result did not show a difference in OS for the bevacizumab arm compared to the placebo arm [ hazard ratio , 1.11 ( 95 % CI , 0.79-1 .56 ) ; P = 0.5567 ] .
RESULTS	Median PFS was also similar in both arms .
RESULTS	Bevacizumab plus capecitabine-cisplatin was well tolerated .
RESULTS	Grade 3-5 adverse events ( AEs ) occurred in 60 % of bevacizumab-treated and 68 % of placebo-treated patients , respectively .
RESULTS	Grade 3-5 AEs of special interest with bevacizumab occurred in 8 % of bevacizumab-treated patients and 15 % of placebo-treated patients , mainly grade 3-5 hemorrhage ( bevacizumab 4 % , placebo 12 % ) .
CONCLUSIONS	Addition of bevacizumab to capecitabine-cisplatin in Chinese patients with advanced gastric cancer did not improve outcomes in AVATAR .
CONCLUSIONS	There was no difference in OS between the two arms and PFS was similar in both arms .
CONCLUSIONS	Safety findings were as previously experienced with bevacizumab , including AVAGAST ; no new safety signals were reported .

###25500220
BACKGROUND	Excessive recreational screen time ( i.e. , screen use for entertainment ) is a global public health issue associated with adverse mental and physical health outcomes .
BACKGROUND	Considering the growing popularity of screen-based recreation in adolescents , there is a need to identify effective strategies for reducing screen time among adolescents .
BACKGROUND	The aim of this paper is to report the rationale and study protocol for the ` Switch-off 4 Healthy Minds ' ( S4HM ) study , an intervention designed to reduce recreational screen time among adolescents .
METHODS	The S4HM intervention will be evaluated using a cluster randomized controlled trial in eight secondary schools ( N = 322 students ) in New South Wales , Australia .
METHODS	The 6-month multi-component intervention will encourage adolescents to manage their recreational screen time using a range of evidence-based strategies .
METHODS	The intervention is grounded in Self-Determination Theory ( SDT ) and includes the following components : an interactive seminar for students , eHealth messaging , behavioral contract and parental newsletters .
METHODS	All outcomes will be assessed at baseline and at 6-months ( i.e. , immediate post-test ) .
METHODS	The primary outcome is recreational screen time measured by the Adolescent Sedentary Activity Questionnaire ( ASAQ ) .
METHODS	Secondary outcomes include : self-reported psychological well-being , psychological distress , global physical self-concept , resilience , pathological video gaming and aggression , and objectively measured physical activity ( accelerometry ) and body mass index ( BMI ) .
METHODS	Hypothesized mediators of behavior change will also be explored .
CONCLUSIONS	The S4HM study will involve the evaluation of an innovative , theory-driven , multi-component intervention that targets students and their parents and is designed to reduce recreational screen time in adolescents .
CONCLUSIONS	The intervention has been designed for scalability and dissemination across Australian secondary schools .

###25354689
BACKGROUND	Estimates show that as many as one in 10 patients are harmed while receiving hospital care .
BACKGROUND	Previous strategies to improve safety have focused on developing incident reporting systems and changing systems of care and professional behaviour , with little involvement of patients .
BACKGROUND	The need to engage with patients about the quality and safety of their care has never been more evident with recent high profile reviews of poor hospital care all emphasising the need to develop and support better systems for capturing and responding to the patient perspective on their care .
BACKGROUND	Over the past 3 years , our research team have developed , tested and refined the PRASE ( Patient Reporting and Action for a Safe Environment ) intervention , which gains patient feedback about quality and safety on hospital wards .
METHODS	A multi-centre , cluster , wait list design , randomised controlled trial with an embedded qualitative process evaluation .
METHODS	The aim is to assess the efficacy of the PRASE intervention , in achieving patient safety improvements over a 12-month period.The trial will take place across 32 hospital wards in three NHS Hospital Trusts in the North of England .
METHODS	The PRASE intervention comprises two tools : ( 1 ) a 44-item questionnaire which asks patients about safety concerns and issues ; and ( 2 ) a proforma for patients to report ( a ) any specific patient safety incidents they have been involved in or witnessed and ( b ) any positive experiences .
METHODS	These two tools then provide data which are fed back to wards in a structured feedback report .
METHODS	Using this report , ward staff are asked to hold action planning meetings ( APMs ) in order to action plan , then implement their plans in line with the issues raised by patients in order to improve patient safety and the patient experience.The trial will be subjected to a rigorous qualitative process evaluation which will enable interpretation of the trial results .
METHODS	fieldworker diaries , ethnographic observation of APMs , structured interviews with APM lead and collection of key data about intervention wards .
METHODS	Intervention fidelity will be assessed primarily by adherence to the intervention via scoring based on an adapted framework .
CONCLUSIONS	This study will be one of the largest patient safety trials ever conducted , involving 32 hospital wards .
CONCLUSIONS	The results will further understanding about how patient feedback on the safety of care can be used to improve safety at a ward level .
CONCLUSIONS	Incorporating the ` patient voice ' is critical if patient feedback is to be situated as an integral part of patient safety improvements .
BACKGROUND	ISRCTN07689702 , 16 Aug 2013 .

###25330096
OBJECTIVE	We aim to obtain the intra-subject coefficient of variability of a highly variable antidepressant agomelatine in humans , and propose an adjusted bioequivalence assessment strategy .
METHODS	A single-dose , randomized crossover design was conducted in four periods ( reference administered thrice , placebo administered once ) separated by seven days .
METHODS	A validated LC-MS/MS assay was used to measure drug concentrations in serial blood samples .
RESULTS	The intra-subject coefficient of variability was calculated using the residual variance of ANOVA analysis , and the results for Cmax and AUC0-t was 78.34 % and 43.52 % , respectively , in Chinese healthy subjects .
RESULTS	The sample size required for standard BE study were 124 ( 192 , 340 ) if the expected deviation between the reference and generic products was set to 0 ( 5 % , 10 % ) .
CONCLUSIONS	Agomelatine meets the criteria for highly variable drug in Chinese healthy male subjects , and the traditional BE criteria for agomelatine needs to be adjusted to alleviate the resource and ethical burden of using a large numbers of subjects in clinical trials .
CONCLUSIONS	Our clinical data on the intra-subject variability of agomelatine PK in Chinese healthy population enables to adjust bioequivalence ( BE ) assessment approach for agomelatine based on the RSABE approaches recommended by regulatory agencies .
BACKGROUND	ChiCTR.org ChiCTR-TTRCC-13003835 .

###25424990
OBJECTIVE	Impairment of HDL function has been associated with cardiovascular events in patients with kidney failure .
OBJECTIVE	The protein composition of HDLs is altered in these patients , presumably compromising the cardioprotective effects of HDLs .
OBJECTIVE	This post hoc study assessed the relation of distinct HDL-bound proteins with cardiovascular outcomes in a dialysis population .
METHODS	The concentrations of HDL-associated serum amyloid A ( SAA ) and surfactant protein B ( SP-B ) were measured in 1152 patients with type 2 diabetes mellitus on hemodialysis participating in The German Diabetes Dialysis Study who were randomly assigned to double-blind treatment of 20 mg atorvastatin daily or matching placebo .
METHODS	The association of SAA ( HDL ) and SP-B ( HDL ) with cardiovascular outcomes was assessed in multivariate regression models adjusted for known clinical risk factors .
RESULTS	High concentrations of SAA ( HDL ) were significantly and positively associated with the risk of cardiac events ( hazard ratio per 1 SD higher , 1.09 ; 95 % confidence interval , 1.01 to 1.19 ) .
RESULTS	High concentrations of SP-B ( HDL ) were significantly associated with all-cause mortality ( hazard ratio per 1 SD higher , 1.10 ; 95 % confidence interval , 1.02 to 1.19 ) .
RESULTS	Adjustment for HDL cholesterol did not affect these associations .
CONCLUSIONS	In patients with diabetes on hemodialysis , SAA ( HDL ) and SP-B ( HDL ) were related to cardiac events and all-cause mortality , respectively , and they were independent of HDL cholesterol .
CONCLUSIONS	These findings indicate that a remodeling of the HDL proteome was associated with a higher risk for cardiovascular events and mortality in patients with ESRD .

###24661791
OBJECTIVE	To assess the effects of different frequencies of thalamic Deep-Brain-Stimulation ( DBS ) on cognitive performance of patients suffering from Essential Tremor ( ET ) .
METHODS	In 17 ET-patients with thalamic-DBS , Tremor-Rating-Scale ( TRS ) , standardized phonemic and semantic verbal fluency ( VF ) , Stroop-Color-Word-Test and Digit-span-test were investigated in three randomized stimulation-settings : i ) high-frequency stimulation ( HFS ) , ii ) low-frequency stimulation ( LFS ) and iii ) OFF-stimulation ( DBS-OFF ) .
METHODS	Paired-samples t-test for TRS and one-way repeated measures analysis of variance for cognitive performance were calculated .
RESULTS	Tremor was reduced during HFS ( MeanTRS-HFS = 12.9 9.6 ) compared to DBS-OFF ( MeanTRS-OFF = 44.4 19.8 , P < .001 ) and to LFS ( MeanTRS-10 Hz = 50.0 24.2 ; P < .001 ) .
RESULTS	While performance of Stroop-task and digit-span remained unaffected by stimulation-settings ( P > .05 ) , phonemic and semantic VF differed significantly between the three conditions ( FPvf = 5.28 , FSvf = 3.41 , both P < .05 ) .
RESULTS	Post-hoc comparisons revealed significant differences for both phonemic and semantic VF between LFS ( MeanPvf-10 Hz = 54.6 9.2 , MeanSvf-10 Hz = 56.4 7.9 ) and HFS ( MeanPvf-ON = 48.3 11.4 , MeanSvf-ON = 51.1 11.0 , both P < .05 ) , while DBS-OFF ( MeanPvf-OFF = 51.2 9.3 , MeanSvf-OFF = 53.6 12.9 ) and HFS and DBS-OFF and LFS did not differ significantly ( P > .05 ) .
CONCLUSIONS	HFS compared to LFS or DBS-OFF significantly reduced tremor but simultaneously worsened VF while working memory and cognitive inhibition remained unaffected .
CONCLUSIONS	In contrast , LFS enhanced VF but did not ameliorate tremor .
CONCLUSIONS	The data emphasize the relevance of thalamocortical loops for verbal fluency but also suggest that more sophisticated DBS-regimes in ET may improve both motor and cognitive performance .

###24743226
BACKGROUND	Previous findings suggest that language disorders may occur in severely brain-injured patients and could interfere with behavioral assessments of consciousness .
BACKGROUND	However , no study investigated to what extent language impairment could affect patients ' behavioral responses .
BACKGROUND	Objective .
BACKGROUND	To estimate the impact of receptive and/or productive language impairments on consciousness assessment .
METHODS	Twenty-four acute and subacute stroke patients with different types of aphasia ( global , n = 11 ; Broca , n = 4 ; Wernicke , n = 3 ; anomic , n = 4 ; mixed , n = 2 ) were recruited in neurology and neurosurgery units as well as in rehabilitation centers .
METHODS	The Coma Recovery Scale-Revised ( CRS-R ) was administered .
RESULTS	We observed that 25 % ( 6 out of 24 ) of stroke patients with a diagnosis of aphasia and 54 % ( 6 out of 11 ) of patients with a diagnosis of global aphasia did not reach the maximal CRS-R total score of 23 .
RESULTS	An underestimation of the consciousness level was observed in 3 patients with global aphasia who could have been misdiagnosed as being in a minimally conscious state , even in the absence of any documented period of coma .
RESULTS	More precisely , lower subscores were observed on the communication , motor , oromotor , and arousal subscales .
CONCLUSIONS	Consciousness assessment may be complicated by the co-occurrence of severe language deficits .
CONCLUSIONS	This stresses the importance of developing new tools or identifying items in existing scales , which may allow the detection of language impairment in severely brain-injured patients .

###24626819
BACKGROUND	Prenatal consumption of omega-3 fatty acids can act as an adjuvant in the development of the immune system and affect the inflammatory response of neonates .
METHODS	We conducted a double-blind , randomized , placebo-controlled trial in Cuernavaca , Mexico .
METHODS	We randomly assigned 1,094 pregnant women ( 18-35 years of age ) to receive 400 mg/d of algal docosahexaenoic acid ( DHA ) or placebo from 18 to 22 weeks of gestation through delivery .
METHODS	Birth outcomes and respiratory symptoms information until 18 months were available for 869 mother-child pairs .
METHODS	Questionnaires were administered , and maternal blood samples were obtained at baseline .
METHODS	Maternal atopy was based on specific IgE levels .
METHODS	During follow-up , information on infants ' respiratory symptoms was collected through questionnaires administered at 1 , 3 , 6 , 9 , 12 , and 18 months of age .
METHODS	Negative binomial regression models were used to evaluate the effect of supplementation on respiratory symptoms in infants .
RESULTS	Among infants of atopic mothers , a statistically significant protective effect of DHA treatment was observed on phlegm with nasal discharge or nasal congestion ( 0.78 ; 95 % CI , 0.60-1 .02 ) and fever with phlegm and nasal discharge or nasal congestion ( 0.53 ; 95 % CI , 0.29-0 .99 ) , adjusting for potential confounders .
CONCLUSIONS	Our results support the hypothesis that DHA supplementation during pregnancy may decrease the incidence of respiratory symptoms in children with a history of maternal atopy .
BACKGROUND	ClinicalTrials.gov ; No. : NCT00646360 ; URL : www.clinicaltrials.gov .

###24519908
BACKGROUND	Physical activity ( PA ) predicts cardiovascular mortality in the population at large .
BACKGROUND	Less is known about its prognostic value in patients with chronic heart failure ( HF ) .
RESULTS	Data from 836 patients with implantable cardioverter defibrillator without or with cardiac resynchronization therapy enrolled in the Sensitivity of the InSync Sentry OptiVol feature for the prediction of Heart Failure ( SENSE-HF ) ( 1 ) study and the Diagnostic Outcome Trial in Heart Failure ( DOT-HF ) were pooled .
RESULTS	The devices continuously measured and stored total daily active time ( single-axis accelerometer ) .
RESULTS	Early PA ( average daily activity over the earliest 30-day study period ) was studied as a predictor of time to death or HF-related hospital admission ( primary end point ) .
RESULTS	Data from 781 patients were analyzed ( 6510 years ; 85 % men ; left ventricular ejection fraction , 267 % ) .
RESULTS	Older age , shorter height , ischemic cause , peripheral artery disease , atrial fibrillation , diabetes mellitus , rales , peripheral edema , higher New York Heart Association class , lower diastolic blood pressure , and no angiotensin II receptor blocker/angiotensin-converting enzyme inhibitor use were associated with reduced early PA. .
RESULTS	The primary end point occurred in 135 patients ( 157 months of follow-up ) .
RESULTS	In multivariable analysis including baseline variables , early PA predicted death or HF hospitalization , with a 4 % reduction in risk for each 10 minutes per day additional activity ( hazard ratio [ HR ] , 0.96 ; confidence interval [ CI ] , 0.94-0 .98 ; P = 0.0002 compared with a model with the same baseline variables but without PA ) .
RESULTS	PA also predicted death ( HR , 0.93 ; CI , 0.90-0 .96 ; P < 0.0001 ) and HF hospitalization ( HR , 0.97 ; CI , 0.95-0 .99 ; P = 0.011 ) .
CONCLUSIONS	Early PA , averaged over a 30-day window early after defibrillator implantation or cardiac resynchronization therapy in patients with chronic HF , predicted death or HF hospitalization , as well as mortality and HF hospitalization separately , accounting for baseline HF severity .
CONCLUSIONS	Clinical Trial Registration Information - URL : http://www.clinicaltrials.gov .
CONCLUSIONS	Unique identifiers : NCT00400985 , NCT00480077 .

###25136645
OBJECTIVE	To comprehensively evaluate the effect of a short-term diabetes self-management education ( DSME ) on metabolic markers and atherosclerotic parameters in patients with type 2 diabetes .
METHODS	76 patients with type 2 diabetes were recruited in this study .
METHODS	They were divided into the intervention group ( n = 36 ) and control group ( n = 40 ) .
METHODS	The patients in the intervention group received a 3-month intervention , including an 8-week education on self-management of diabetes mellitus and subsequent 4 weeks of practice of the self-management guidelines .
METHODS	The patients in the control group received standard advice on medical nutrition therapy .
METHODS	Metabolic markers , carotid intima-media thickness ( CIMT ) , and carotid arterial stiffness ( CAS ) of the patients in both groups were assessed before and after the 3-month intervention .
RESULTS	There was a significant reduction in hemoglobin A1c ( HbA1c , -0.2 0.56 % versus 0.08 0.741 % ; P < 0.05 ) and body weight ( -1.19 1.39 kg versus -0.61 2.04 kg ; P < 0.05 ) in the intervention group as compared to the control group .
RESULTS	However , no significant improvements were found in other metabolic markers , CIMT and CAS ( P > 0.05 ) .
CONCLUSIONS	DSME can improve HbA1c and body weight in patients with type 2 diabetes .

###24314422
OBJECTIVE	To compare anterior chamber paracentesis ( ACP ) with standard medical management of acute primary angle closure ( APAC ) .
METHODS	Prospective study .
METHODS	Patients with APAC and intraocular pressure ( IOP ) 50 mm Hg were enrolled .
METHODS	Patients were randomized to receive ACP and medical treatment ( group 1 ) or medical management alone ( group 2 ) .
RESULTS	There were 26 patients ( mean age 69.3 10.4 years , 31 eyes ) in group 1 and 28 patients ( mean age 67.0 9.7 years , 30 eyes ) in group 2 .
RESULTS	The IOP in group 1 was significantly lower at 15 minutes , 30 minutes , and 1 hour after treatment ( p < 0.05 ) .
RESULTS	At 1 , 2 , and 24 hours after treatment , visual acuity was significantly better in group 1 than in group 2 .
RESULTS	At each time point after treatment , the grade of corneal edema was not different between the groups .
RESULTS	Pain score at 1 and 2 hours after treatment was significantly lower in group 1 than in group 2 ; however , no difference was noted at 24 hours after treatment .
RESULTS	The mean follow-up period in group 1 was 16.1 1.3 months and in group 2 was 15.6 1.4 months ( p = 0.803 ) .
RESULTS	At last follow-up , IOP , pupil size , number of eyes with nonreactive pupils , and centre endothelial cell counts were not different ; however , visual acuity was significantly better in group 1 ( 0.43 0.06 logMAR vs 0.74 0.10 logMAR , p = 0.007 ) .
CONCLUSIONS	Immediate ACP is a safe and effective for rapidly lowering IOP , and is associated with better visual acuity than medical treatment alone .

###24356922
OBJECTIVE	Bone fracture is a common cause of acute pain in emergency and orthopedics departments .
OBJECTIVE	Targeting the multifaceted mechanisms of pain with combinations of multiple analgesics ( multimodal analgesia ) can increase the pain control efforts efficacy and decrease the adverse effects of each medication .
METHODS	One hundred and fifty-three patients with acute bone fracture were randomly allocated to two groups receiving intravenous morphine sulfate ( 74 patients ) or oral oxycodone plus intravenous acetaminophen ( 79 patients ) .
METHODS	Pain scores and drugs ' adverse effects were assessed 10 , 30 and 60 min after treatment .
RESULTS	Pain scores were similar between groups before , 30 and 60 min after medication but patients in morphine sulfate group experienced less pain 10 min after medication .
RESULTS	Eight ( 10.8 % ) patients in morphine sulfate group and 26 ( 32.9 % ) patients in acetaminophen/oxycodone group experienced nausea that was statistically significant higher ( P value = 0.001 ) .
RESULTS	Itching was seen in 12 ( 15.1 % ) patients of acetaminophen/oxycodone group and three ( 4.0 % ) patients of patients in morphine sulfate group ( P value = 0.02 ) .
CONCLUSIONS	Intravenous acetaminophen plus oral oxycodone is as effective as intravenous morphine sulfate in acute pain control in emergency department but with a less desirable safety profile .

###24976431
OBJECTIVE	Salacia oblonga , Tinospora cordifolia , Emblica offinalis Gaertn , Curcuma longa and Gymnema sylvestre are Ayurvedic medicinal plants reported to lower plasma glucose levels in animal models .
OBJECTIVE	To our knowledge , however , no clinical validations of those extracts for efficacy have been .
OBJECTIVE	The aim of this study was to evaluate the effect of polyherbal combination in patients with type 2 diabetes mellitus .
METHODS	We screened 250 patients enrolled in a diabetes mellitus screening camp held at District Ayurvedic Hospital , Kottayam , Kerala , India .
METHODS	Of these , 89 patients diagnosed with type 2 diabetes mellitus and 50 healthy volunteers of similar age group were included in the study .
METHODS	Patients were treated with a polyherbal combination drug namely G-400 ( 1000 mg/d ) for 8 wk with a follow-up of 2wk interval .
RESULTS	Fasting and postprandial blood glucose levels measured after 8 wk of G-400 treatment in patients were significantly lower .
RESULTS	Indeed diabetic rats showed similar protection with G-400 administration .
RESULTS	Furthermore , glycosylated hemoglobin , serum total cholesterol , both high - and low-density lipoprotein cholesterol , and triglycerides showed a significant improvement in G-400-administered patients .
RESULTS	Toxicologic profile of the drug was assessed by analyzing the enzyme activities of alkaline phosphatase and alanine aminotransferase along with the concentration of blood urea nitrogen and creatinine in blood and found insignificant change compared with control .
CONCLUSIONS	Short-term supplementation of G-400 not only attenuates the hyperglycemia , but also acts as hypolipidemic agent in patients with diabetes .
CONCLUSIONS	Further study should be done for the long-term effect of the drug in larger populations .

###25577909
OBJECTIVE	To study therapeutic effects of comprehensive traditional Chinese medicine therapy for preventing postsurgery stiffness after operation for terrible triad of the elbow .
METHODS	From December 2008 to December 2013,32 patients with elbow triad were randomly divided into two groups : therapy group and control group .
METHODS	There were 17 patients in control group including 12 males and 5 females with a mean age of ( 41.0 7.1 ) years old .
METHODS	The patients in control group were received the past procedure therapy .
METHODS	There were 15 patients in therapy group , including 10 males and 5 females with a mean age of ( 41.3 7.6 ) years old .
METHODS	The patients in therapy group were received comprehensive traditional Chinese medicine therapy , including passive exercise training at early stage ( 0 to 2 weeks after operation ) , transition from passive to active exercise training at middle stage ( 3 to 4 weeks after operation ) , and active exercise training at late stage ( 5 to 12 weeks after operation ) .
METHODS	Other treatment methods , such as orally taking or externally use of Chinese herbal medicine , manipulation and physiotherapy , were used at all stages .
METHODS	The Mayo Elbow Performance Score , patient satisfaction and complications were evaluated and analyzed .
RESULTS	All the patients were followed up , and the mean duration was 7.5 months .
RESULTS	There were no complications such as internal fixation loosing , obvious displacement fracture and heterotopic ossification occurred .
RESULTS	The Mayo score and patient satisfaction in therapy group were higher than those in control group ( t = 12.78 , P = 0.00 ; 2 = 8.719 , P = 0.003 ) .
RESULTS	Seven patients needed reoperation in control group , compared with 1 patient in therapy group ( 2 = 4.626 , P = 0.032 ) .
CONCLUSIONS	The comprehensive traditional Chinese medicine therapy is effective to prevent postoperative stiffness after operation for terrible triad of the elbow by using different methods at different stages , which is worthy of spread and application .

###24848851
OBJECTIVE	The purpose of this study was to assess the repeatability of water-fat MRI and diffusion-tensor imaging ( DTI ) as quantitative biomarkers of pediatric lower extremity skeletal muscle .
METHODS	MRI at 3 T of a randomly selected thigh and lower leg of seven healthy children was studied using water-fat separation and DTI techniques .
METHODS	Muscle-fat fraction , apparent diffusion coefficient ( ADC ) , and fractional anisotropy ( FA ) values were calculated .
METHODS	Test-retest and interrater repeatability were assessed by calculating the Pearson correlation coefficient , intraclass correlation coefficient , and Bland-Altman analysis .
RESULTS	Bland-Altman plots show that the mean difference between test-retest and interrater measurements of muscle-fat fraction , ADC , and FA was near 0 .
RESULTS	The correlation coefficients and intraclass correlation coefficients were all between 0.88 and 0.99 ( p < 0.05 ) , suggesting excellent reliability of the measurements .
RESULTS	Muscle-fat fraction measurements from water-fat MRI exhibited the highest intraclass correlation coefficient .
RESULTS	Interrater agreement was consistently better than test-retest comparisons .
CONCLUSIONS	Water-fat MRI and DTI measurements in lower extremity skeletal muscles are objective repeatable biomarkers in children .
CONCLUSIONS	This knowledge should aid in the understanding of the number of participants needed in clinical trials when using these determinations as an outcome measure to noninvasively monitor neuromuscular disease .

###25249560
BACKGROUND	As new techniques emerge to quantify patients ' health status , new opportunities are created to validate patient-reported outcome questionnaires .
BACKGROUND	The Seattle Angina Questionnaire ( SAQ ) , a widely used coronary artery disease-specific health status tool , has not been validated against daily records of angina frequency and sublingual nitroglycerin ( SL NTG ) use .
BACKGROUND	Additional evidence supporting the validity of the SAQ could justify its broader use as an outcome for clinical studies designed to evaluate treatments that may improve patients ' symptoms , function , and quality of life .
RESULTS	We used data from 917 patients with type 2 diabetes mellitus , coronary artery disease , and stable angina from the multinational Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina ( TERISA ) trial .
RESULTS	The number of angina episodes and SL NTG used were recorded and transmitted daily using an electronic diary .
RESULTS	In cross-sectional analyses , there was a strong relationship between the 2 SAQ angina frequency questions ( ie , frequency of angina and SL NTG use ) and the corresponding diary responses , with correlation coefficients of -0.64 for angina frequency ( 95 % confidence interval,-0 .68 to -0.60 ) and -0.69 for SL NTG use ( 95 % confidence interval , -0.73 to -0.66 ) .
RESULTS	Longitudinally , changes in SAQ angina frequency scores from day 1 to week 8 also correlated with changes in angina frequency ( -0.42 ; 95 % confidence interval , -0.48 to -0.30 ) and SL NTG use by diary ( -0.38 ; 95 % confidence interval , -0.43 to -0.32 ) over the corresponding time period .
RESULTS	Correlations were similar when stratified by age , sex , or geography .
CONCLUSIONS	In a multinational cohort of patients with stable angina , the SAQ angina frequency domain was significantly correlated , both cross sectionally and longitudinally , with daily diary entries of angina frequency and SL NTG use .
CONCLUSIONS	These data further support the validity of the SAQ angina frequency domain across a broad spectrum of patients with stable angina .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01425359 .

###24520783
OBJECTIVE	To observe the change of intra-abdominal pressure ( IAP ) in severe acute pancreatitis ( SAP ) patients , and to study the effect of Qingyi Chengqi Decoction ( QCD ) on it .
METHODS	Eighty-six SAP patients from Department of General Surgery and Department of Digestive Diseases , Qingyang People 's Hospital , Gansu Province , who were in line with diagnosis standard of SAP , were assigned to the treatment group ( 44 cases ) and the control group ( 42 cases ) from March 2012 to May 2013 .
METHODS	All patients received routine Western medicine .
METHODS	Those in the treatment group took QCD additionally .
METHODS	Main clinical symptoms and APACHE II were observed .
METHODS	The serum levels of amylase ( AMY ) , C-reactive protein ( CRP ) , and IAP were examined .
METHODS	The incidence of secondary infection rate ( SIR ) , drainage rate ( percutaneous catheter drainage and operation ) , mortality , and mean days in ward were also recorded .
RESULTS	Main clinical symptoms were significantly improved in the treatment group .
RESULTS	APACHE II score , serum levels of AMY , CRP , and IAP obviously decreased in the treatment group .
RESULTS	The incidence of SIR , drainage rate , and the mortality were also significantly lower in the treatment group than in the control group .
RESULTS	The mean days in ward were also markedly shortened ( P < 0.01 ) .
CONCLUSIONS	QCD could relieve inflammatory response , lower IAP , SIR , and mortality , increase the curative rate and improve the prognosis of SAP .

###24643810
OBJECTIVE	The incidence of postoperative pharyngolaryngeal complications after laryngeal mask airway ( LMA ) insertion can be as high as 50 % .
OBJECTIVE	Over-inflation of the LMA cuff may be a causal factor .
OBJECTIVE	We conducted a single-centre parallel group randomised trial to determine whether maintaining LMA-ProSeal intra-cuff pressures below 60 cm H2O decreases postoperative pharyngolaryngeal complications .
METHODS	We recruited 120 adult patients who were scheduled to undergo elective surgery under general anaesthesia .
METHODS	Appropriate sized LMA-ProSeal was inserted and the cuff was inflated with air ( to no more than the maximum recommended volume ) until there was no audible leak .
METHODS	Patients were randomised to either the control group ( n = 60 ) , where the intra-cuff pressure was noted and no further action was taken , or to the pressure-monitored group ( n = 60 ) , where intra-cuff pressure was maintained below 60 cm H2O .
METHODS	Pharyngolaryngeal complications consisting of sore throat , dysphonia and dysphagia were assessed at 1 , 2 , and 24 h postoperatively .
METHODS	Patients , anaesthesiologists and assessors were blinded to group allocation .
METHODS	The primary outcome was a composite endpoint of any pharyngolaryngeal complication at any of the three time points .
METHODS	Secondary outcomes were the incidence of individual outcomes at each time point .
RESULTS	The incidence of pharyngolaryngeal complications at any time point was 42 % in the routine care group and 32 % in the pressure-monitored group ( 95 % CI for difference +28 to -7 % , p = 0.26 ) .
RESULTS	There was no difference between groups for any of the secondary outcomes .
CONCLUSIONS	Our study failed to demonstrate a statistically significant reduction in postoperative pharyngolaryngeal complications by limiting intra-cuff pressures in the LMA-Proseal .

###25535659
OBJECTIVE	To evaluate canine erythrocyte concentrates ( ECs ) for the presence of procoagulant phospholipid ( PPL ) , determine whether PPL concentration changes during the course of storage of ECs , and ascertain whether prestorage leukoreduction ( removal of leukocytes via gravity filtration ) reduces the development of PPL .
METHODS	10 whole blood units ( 420 g each ) collected from 10 random-source , clinically normal dogs ( 1 U/dog ) .
METHODS	The dogs were randomized to 1 of 2 groups .
METHODS	Of the 10 whole blood units collected , 5 were processed through a standard method , and 5 underwent leukoreduction .
METHODS	Whole blood units were processed to generate ECs , from which aliquots were aseptically collected from each unit weekly for 5 weeks .
METHODS	Supernatants from the concentrates were evaluated for procoagulant activity , which was converted to PPL concentration , by use of an automated assay and by measurement of real-time thrombin generation .
RESULTS	Supernatants from stored canine ECs contained procoagulant activity as measured by both assays .
RESULTS	In general , the PPL concentration gradually increased during the storage period , but leukoreduction reduced the development of increased procoagulant activity over time .
CONCLUSIONS	The presence of PPL in canine ECs may be associated with procoagulant and proinflammatory effects in vivo , which could have adverse consequences for dogs treated with ECs .

###25762759
BACKGROUND	Treatment of tobacco use in mental health settings is rare despite high rates of comorbidity .
BACKGROUND	With a focus on early intervention , we evaluated a tobacco treatment intervention among adolescents and young adults recruited from outpatient , school-based , and residential mental health settings and tested for gender differences .
METHODS	Intervention participants received computerized motivational feedback at baseline , 3 months , and 6 months and were offered 12 weeks of cessation counseling and nicotine patches .
METHODS	Usual care participants received a self-help guide and brief cessation advice .
METHODS	We examined 7-day point prevalence abstinence with biochemical confirmation at 3 , 6 , and 12 months ; smoking reduction ; and 24-hr quit attempts .
RESULTS	At baseline , the sample ( N = 60 , 52 % female , mean age = 19.52.9 years , 40 % non-Hispanic Caucasian ) averaged 76 cigarettes/day , 62 % smoked daily , 38 % smoked 30 min of waking , 12 % intended to quit in the next month , 47 % had a parent who smoked , and 3 of 5 of participants ' closest friends smoked on average .
RESULTS	During the 12-month study , 47 % of the sample reduced their smoking , 80 % quit for 24 hr , and 11 % , 13 % , and 17 % confirmed 7-day point prevalence abstinence at 3 - , 6 - , and 12-month follow-up , respectively , with no differences by treatment condition ( ps > .400 ) .
RESULTS	Over time , abstinence was greater among girls ( adjusted odds ratio [ AOR ] = 8.9 ) than among boys , and abstinence was greater for lighter smokers than heavier smokers ( AOR = 4.5 ) ( p < .05 ) .
RESULTS	No mental health or other measured variables predicted abstinence .
CONCLUSIONS	Adolescent and young adult smokers with mental health concerns are a challenging group to engage and to effectively treat for tobacco addiction , particularly heavier smokers and boys .
CONCLUSIONS	Innovative approaches are needed .

###25163440
OBJECTIVE	Limited pharmacological options are available for the management of Alzheimer 's disease ( AD ) in severe stages .
OBJECTIVE	Cognitive-enhancing properties of saffron , the dried stigma of Crocus sativus L. , have been evidenced in different studies .
OBJECTIVE	We aimed to compare the efficacy and safety of saffron extract versus memantine in reducing cognitive deterioration of patients with moderate to severe AD .
METHODS	In this randomized double-blind parallel-group study , 68 patients with moderate to severe AD ( Mini-Mental State Examination score of 8-14 ) received memantine ( 20mg/day ) or saffron extract ( 30mg/day ) capsules for 12months .
METHODS	Participants were evaluated every month by Severe Cognitive Impairment Rating Scale ( SCIRS ) and Functional Assessment Staging ( FAST ) in addition to recording the probable adverse events .
RESULTS	Both treatment groups showed similar outcomes as demonstrated by insignificant effect for timetreatment interaction on SCIRS scores [ F ( 2.95 , 194.78 ) = 2.25 , p = 0.08 ] .
RESULTS	There was no significant difference between the two groups in the scores changes from baseline to the endpoint on SCIRS ( p = 0.38 ) and FAST ( p = 0.87 ) .
RESULTS	The frequency of adverse events was not significantly different between the two groups as well .
CONCLUSIONS	In addition to its favorable safety profile , 1-year administration of saffron extract capsules showed to be comparable with memantine in reducing cognitive decline in patients with moderate to severe AD .
CONCLUSIONS	Confirmatory studies with larger sample sizes and longer follow-up periods are warranted .

###25651741
BACKGROUND	NT-pro-BNP level is increased in both systolic and diastolic heart failure ( HF ) and furthermore increases more during exercise .
BACKGROUND	In diastolic HF , NT-pro-BNP might increase more during isometric exercise than during isotonic exercises because of increased afterload .
BACKGROUND	We studied NT-pro-BNP values during isometric ( hand-grip ) and isotonic ( cycloergometer ) exercise in HF patients with preserved left ventricular ejection fraction and different degrees of diastolic dysfunction .
METHODS	We studied 87 patients , aged 58 7.9 years , 42.6 % females , with heart failure with LVEF > 40 % and diastolic dysfunction .
METHODS	The patients were randomly distributed in two groups : 43 patients ( Group I ) and 44 patients ( Group II ) .
METHODS	Group I underwent ramp exercise testing on a cycloergometer .
METHODS	Group II performed an isometric handgrip test .
METHODS	Plasma NT-pro-BNP levels were measured at rest and immediately after exercise .
RESULTS	An abnormal relaxation ( AR ) pattern was recorded in 30 patients of Group I and 31 patients of Group II .
RESULTS	Pseudonormalisation ( PSN ) and restrictive ( R ) pattern were noted in 13 patients of each group .
RESULTS	As concerns Group I , NT-pro-BNP levels were increased in all patients , particularly in those with PSN or R pattern ( p < 0.05 ) .
RESULTS	During exercise NT-pro-BNP decreases significantly in AR ( 1033 516.63 to 800.51 675.89 pg/mL ) but not in PSN or R patients ( 1656.75 977.48 to 1486.38 1182.51 pg/mL ) .
RESULTS	For Group II , NT-pro-BNP registered a similar increase as in Group I , with maximal values in PSN or R subgroup as compared to abnormal relaxation ( p < 0.05 ) .
RESULTS	At peak exercise , NT-pro-BNP was practically unchanged as compared to the rest values for the whole group ( -6 % ) and for the two subgroups ( AR -6.7 % and PSN or R -5.21 % ) .
RESULTS	We compared rest and exercise NT-pro-BNP with E/E ' ratio > 12 in order to identify increased diastolic filling pressure in the LV ; AUC was 0.70 and 0.66 for rest and exercise NT-pro-BNP in case of isotonic testing and 0.74 and 0.72 in case of isometric exercise .
CONCLUSIONS	Our data suggest that in HF patients with preserved left ventricular ejection fraction , moderate isotonic and isometric exercises do not determine a significant increase ( isometric exercise ) or even decrease ( isotonic exercise ) in the value of NT-pro-BNP .

###25581657
BACKGROUND	Positively reinforcing properties of alcohol are in part mediated by activation of the ventral striatum ( VS ) .
BACKGROUND	Alcohol-induced release of endogenous opioids is thought to contribute to this response .
BACKGROUND	Preclinical studies show that the opioid antagonist naltrexone ( NTX ) can block this cascade , but its ability to do so in treatment-seeking alcoholics has not been examined .
BACKGROUND	Our objective was to study the effects of NTX on alcohol-induced VS activation and on amygdala response to affective stimuli in treatment-seeking alcohol-dependent inpatients .
METHODS	Sixty-three treatment-seeking alcoholics were randomized to receive NTX ( 50mg ) or placebo ( PLC ) daily .
METHODS	On Day 7 , participants underwent an alcohol cue reactivity session , and craving was measured using the Penn Alcohol Craving Scale .
METHODS	On Day 9 , participants received a saline infusion followed by an alcohol infusion and also viewed affective stimuli in a magnetic resonance scanner .
RESULTS	Irrespective of medication treatment condition , the alcohol infusion did not activate the VS in the alcohol-dependent patients .
RESULTS	Unexpectedly , VS activation was greater in NTX treated patients than in the PLC group .
RESULTS	NTX treated patients also reported increased craving in response to alcohol cue exposure , and increased subjective response to alcohol ( `` high '' and `` intoxicated '' ) compared to PLC subjects .
RESULTS	No significant effects of alcohol infusion on brain response to affective stimuli were in the NTX or PLC groups .
CONCLUSIONS	Unlike previous findings in social drinkers , a moderate level of intoxication did not activate the VS in treatment-seeking alcoholics .
CONCLUSIONS	This is likely to reflect tolerance to the positively reinforcing properties of alcohol in this clinical population .
CONCLUSIONS	Our findings may help explain the efficacy of NTX to reduce heavy drinking , but not to maintain abstinence .

###24467942
BACKGROUND	Catechol-O-methyltransferase ( COMT ) metabolizes catecholamines in the prefrontal cortex ( PFC ) .
BACKGROUND	A common polymorphism in the COMT gene ( COMT val158met ) has pleiotropic effects on cognitive and emotional processing .
BACKGROUND	The met allele has been associated with enhanced cognitive processing but impaired emotional processing relative to the val allele .
METHODS	We genotyped healthy , white men in relation to the COMT val158met polymorphism .
METHODS	They were given a single 4 mg dose of the selective noradrenaline reuptake inhibitor ( NRI ) reboxetine or placebo in a randomized , double-blind between-subjects model and then completed an emotional memory task 2 hours later .
RESULTS	We included 75 men in the study ; 41 received reboxetine and 34 received placebo .
RESULTS	In the placebo group , met/met carriers did not demonstrate the usual memory advantage for emotional stimuli that was observed in val carriers .
RESULTS	Reboxetine restored this emotional enhancement of memory in met/met carriers , but had no significant effect in val carriers .
CONCLUSIONS	We studied only men , thus limiting the generalizability of our findings .
CONCLUSIONS	We also relied on self-reported responses to screening questions to establish healthy volunteer status , and in spite of the double-blind design , participants were significantly better than chance at identifying their intervention allocation .
CONCLUSIONS	Emotional memory is impaired in healthy met homozygotes and selectively improved in this group by reboxetine .
CONCLUSIONS	This has potential translational implications for the use of reboxetine , which is currently licensed as an antidepressant in several countries , and edivoxetine , a new selective NRI currently in development .

###24980988
BACKGROUND	Topical corticosteroids are used with systemic therapies for treatment of plaque psoriasis , but data from randomized clinical trials to document efficacy of combination therapy are lacking .
OBJECTIVE	To evaluate efficacy and safety of adding topical corticosteroid therapy from the time that etanercept dosage is reduced from initial label dose [ 50 mg twice weekly ( BIW ) ] to maintenance dose [ 50 mg once weekly ( QW ) ] .
METHODS	In this phase 3b , multicentre , randomized , open-label study , patients with moderate-to-severe plaque psoriasis received etanercept 50 mg BIW for 12 weeks , and then were randomized to etanercept 50 mg BIW or 50 mg QW plus topical agent as needed to achieve static physician global assessment ( sPGA ) status of clear for 12 weeks .
METHODS	Endpoints included percentage change in Psoriasis Area and Severity Index ( PASI ) score from week 12 to week 24 ( primary endpoint ) ; proportion of patients achieving 50 % improvement in ( PASI 50 ) , PASI 75 and PASI 90 ; patients achieving sPGA of clear/almost clear ; and change in affected body surface area ( BSA ) .
RESULTS	Mean difference [ 95 % confidence interval ( CI ) ] between etanercept arm ( n = 140 ) and etanercept plus topical arm ( n = 142 ) in change in PASI score from week 12 to week 24 was 16.2 % ( -3.5 % , 35.8 % ) .
RESULTS	PASI response rates were similar between groups .
RESULTS	Percentage ( 95 % CI ) of patients achieving sPGA status of clear/almost clear was 40.6 % ( 32.5 % , 48.6 % ) and 45.8 % ( 37.6 % , 54.0 % ) at week 12 for patients in etanercept and etanercept plus topical arms , respectively , and 53.5 % ( 45.3 % , 61.7 % ) and 45.4 % ( 37.2 % , 53.6 % ) at week 24 .
RESULTS	Difference ( 95 % CI ) between groups in change in affected BSA from week 12 to week 24 was 4.9 % ( -23.4 % , 33.2 % ) .
CONCLUSIONS	Patients who received etanercept 50 mg QW at week 12 plus as-needed topical therapy and those who stayed on etanercept 50 mg BIW maintained clinical response through week 24 with no notable differences in PASI responses .

###26441179
OBJECTIVE	Evidence about the efficacy of laparoscopic resection of rectal cancer is incomplete , particularly for patients with more advanced-stage disease .
OBJECTIVE	To determine whether laparoscopic resection is noninferior to open resection , as determined by gross pathologic and histologic evaluation of the resected proctectomy specimen .
METHODS	A multicenter , balanced , noninferiority , randomized trial enrolled patients between October 2008 and September 2013 .
METHODS	The trial was conducted by credentialed surgeons from 35 institutions in the United States and Canada .
METHODS	A total of 486 patients with clinical stage II or III rectal cancer within 12 cm of the anal verge were randomized after completion of neoadjuvant therapy to laparoscopic or open resection .
METHODS	Standard laparoscopic and open approaches were performed by the credentialed surgeons .
METHODS	The primary outcome assessing efficacy was a composite of circumferential radial margin greater than 1 mm , distal margin without tumor , and completeness of total mesorectal excision .
METHODS	A 6 % noninferiority margin was chosen according to clinical relevance estimation .
RESULTS	Two hundred forty patients with laparoscopic resection and 222 with open resection were evaluable for analysis of the 486 enrolled .
RESULTS	Successful resection occurred in 81.7 % of laparoscopic resection cases ( 95 % CI , 76.8 % -86.6 % ) and 86.9 % of open resection cases ( 95 % CI , 82.5 % -91.4 % ) and did not support noninferiority ( difference , -5.3 % ; 1-sided 95 % CI , -10.8 % to ; P for noninferiority = .41 ) .
RESULTS	Patients underwent low anterior resection ( 76.7 % ) or abdominoperineal resection ( 23.3 % ) .
RESULTS	Conversion to open resection occurred in 11.3 % of patients .
RESULTS	Operative time was significantly longer for laparoscopic resection ( mean , 266.2 vs 220.6 minutes ; mean difference , 45.5 minutes ; 95 % CI , 27.7-63 .4 ; P < .001 ) .
RESULTS	Length of stay ( 7.3 vs 7.0 days ; mean difference , 0.3 days ; 95 % CI , -0.6 to 1.1 ) , readmission within 30 days ( 3.3 % vs 4.1 % ; difference , -0.7 % ; 95 % CI , -4.2 % to 2.7 % ) , and severe complications ( 22.5 % vs 22.1 % ; difference , 0.4 % ; 95 % CI , -4.2 % to 2.7 % ) did not differ significantly .
RESULTS	Quality of the total mesorectal excision specimen in 462 operated and analyzed surgeries was complete ( 77 % ) and nearly complete ( 16.5 % ) in 93.5 % of the cases .
RESULTS	Negative circumferential radial margin was observed in 90 % of the overall group ( 87.9 % laparoscopic resection and 92.3 % open resection ; P = .11 ) .
RESULTS	Distal margin result was negative in more than 98 % of patients irrespective of type of surgery ( P = .91 ) .
CONCLUSIONS	Among patients with stage II or III rectal cancer , the use of laparoscopic resection compared with open resection failed to meet the criterion for noninferiority for pathologic outcomes .
CONCLUSIONS	Pending clinical oncologic outcomes , the findings do not support the use of laparoscopic resection in these patients .
BACKGROUND	clinicaltrials.gov Identifier : NCT00726622 .

###25265096
OBJECTIVE	To investigate the effect of intracervical and intravaginal application of seminal plasma on the endometrium , as assessed by endometrial/subendometrial vascularization and endometrial volume between the day of oocyte retrieval and the day of embryo transfer in an in-vitro fertilization/intracytoplasmic sperm injection ( IVF/ICSI ) cycle .
METHODS	This was a double-blind , placebo-controlled , randomized study including patients undergoing a first or second IVF/ICSI cycle .
METHODS	Homologous seminal plasma or placebo ( sodium chloride ) was injected into the cervix and posterior vaginal fornix just after follicle aspiration .
METHODS	Three-dimensional power Doppler examination was performed 30min before oocyte retrieval and 30min before embryo transfer .
METHODS	Main outcome measures were changes in vascularization flow index ( VFI ) , flow index ( FI ) and vascularization index ( VI ) of the endometrium/subendometrium using VOCAL ( Virtual Organ Computer-aided AnaLysis ) and endometrial volume .
RESULTS	One hundred patients agreed to participate in the study .
RESULTS	Twenty-three patients were excluded , mainly as a result of canceled embryo transfer .
RESULTS	Data were analyzed from 40 patients receiving seminal plasma and 37 receiving placebo .
RESULTS	No significant differences between the two groups were seen in VFI , FI or VI of the endometrium or subendometrium or in endometrial volume on the day of oocyte pick-up and on the day of embryo transfer .
CONCLUSIONS	Neither endometrial/subendometrial vascularization parameters nor endometrial volume seem to be affected by the application of seminal plasma in patients undergoing their first or second IVF/ICSI cycle .

###24289915
OBJECTIVE	To assess the efficacy and safety of lifitegrast ophthalmic solution 5.0 % compared with placebo in subjects with dry eye disease .
METHODS	Prospective , randomized , double-masked , placebo-controlled , parallel arm , multicenter clinical trial .
METHODS	A total of 588 adult subjects with dry eye disease .
METHODS	Eligible subjects were randomized 1:1 to receive topically administered lifitegrast ( 5.0 % ) or placebo ( vehicle ) twice daily for 84 days after a 14-day open-label placebo run-in period .
METHODS	After enrollment ( day 0 ) , subjects were evaluated at days 14 , 42 , and 84 .
METHODS	Key objective ( fluorescein and lissamine staining scores [ Ora scales ] ) and subjective ( Ocular Surface Disease Index [ OSDI ] , 7-item visual analog scale , and ocular discomfort score [ Ora scale ] ) measures were assessed at all visits .
METHODS	The primary objective efficacy measure ( sign ) was mean change from baseline inferior corneal staining score ( ICSS ) at day 84 .
METHODS	The co-primary subjective efficacy measure ( symptom ) was the mean change from baseline in the visual-related function subscale score of the Ocular Surface Disease Index ( VR-OSDI ) .
METHODS	Supportive measures included corneal fluorescein scores ( superior , central , total region ) and conjunctival lissamine scores ( nasal , temporal , total region ) and symptom scores at day 84 .
RESULTS	The study met the primary objective efficacy ICSS end point in demonstrating superiority of lifitegrast compared with placebo ( P = 0.0007 ) .
RESULTS	Lifitegrast significantly reduced corneal fluorescein staining ( superior , P = 0.0392 ; total cornea , P = 0.0148 ) and conjunctival lissamine staining ( nasal , P = 0.0039 ; total conjunctiva , P = 0.0086 ) at day 84 versus placebo .
RESULTS	Significant ( P < 0.05 ) improvements in nasal and total lissamine scores were observed at day 14 and maintained through day 84 .
RESULTS	The study did not meet the co-primary subjective VR-OSDI measure ( P = 0.7894 ) .
RESULTS	However , significant improvements were observed at day 84 in ocular discomfort ( P = 0.0273 ) and eye dryness ( P = 0.0291 ) , the most common and severe symptoms reported at baseline in both groups .
RESULTS	There were no unanticipated or serious ocular adverse events ( AEs ) .
RESULTS	The most frequent reported ocular AEs were transient intermittent instillation site symptoms ( irritation , discomfort ) primarily on the initial lifitegrast dose at day 0 .
CONCLUSIONS	Lifitegrast ophthalmic solution 5.0 % significantly reduced corneal fluorescein and conjunctival lissamine staining and improved symptoms of ocular discomfort and eye dryness compared with placebo when administered twice daily over 84 days .

###24746974
OBJECTIVE	The objectives of this study were to assess whether 25 g/d lupin protein , integrated into a mixed diet , might affect cardiovascular risk factors and whether l-arginine was responsible for these effects .
METHODS	Seventy-two hypercholesterolemic subjects participated in the randomized , controlled , double-blind three-phase crossover study .
METHODS	They were assigned to three diets with 25 g/d lupin protein ( LP ) , milk protein ( MP ) or milk protein plus 1.6 g/d arginine ( MPA ) each for 28 d in a random order interrupted by 6-week washout periods .
METHODS	Lupin protein and the comparator milk protein were incorporated into complex food products ( bread , roll , sausage , and vegetarian spread ) .
METHODS	Arginine was administered via capsules .
METHODS	Sixty-eight subjects were included in final analyses .
RESULTS	Compared with MP , LDL cholesterol was significantly lower after LP .
RESULTS	Compared with MP and MPA , homocysteine was significantly lower after LP .
RESULTS	Compared with baseline , concentrations of total , LDL , and HDL cholesterol significantly decreased after LP and MPA .
RESULTS	Triacylglycerols and uric acid significantly decreased after LP .
RESULTS	The relative changes in total and LDL cholesterol were significantly greater for subjects with severe hypercholesterolemia ( > 6.6 mmol/L ) than those with moderate hypercholesterolemia ( 5.2-6 .6 mmol/L ) .
CONCLUSIONS	The present study showed for the first time that incorporation of 25 g/d of lupin protein into a variety of complex food products lowers total and LDL cholesterol , triacylglycerols , homocysteine , and uric acid in hypercholesterolemic subjects .
CONCLUSIONS	The hypocholesterolemic effect is stronger in subjects with severe hypercholesterolemia .
CONCLUSIONS	Arginine might be responsible for some , but not all of the beneficial effects of lupin protein .
CONCLUSIONS	This trial was registered at http://clinicaltrials.gov ( study ID number NCT01598649 ) .

###24977750
BACKGROUND	Liquid preserved packed red blood cell ( LPRBC ) transfusions are used to treat anemia and increase end-organ perfusion .
BACKGROUND	Throughout their storage duration , LPRBCs undergo biochemical and structural changes collectively known as the storage lesion .
BACKGROUND	These changes adversely affect perfusion and oxygen off-loading .
BACKGROUND	Cryopreserved RBCs ( CPRBC ) can be stored for up to 10 years and potentially minimize the associated storage lesion .
BACKGROUND	We hypothesized that CPRBCs maintain a superior biochemical profile compared with LPRBCs .
METHODS	This was a prospective , randomized , double-blinded study .
METHODS	Adult trauma patients with an Injury Severity Score ( ISS ) greater than 4 and an anticipated 1-U to 2-U transfusion of PRBCs were eligible .
METHODS	Enrolled patients were randomized to receive either CPRBCs or LPRBCs .
METHODS	Serum proteins ( haptoglobin , serum amyloid P , and C-reactive protein ) , proinflammatory and anti-inflammatory cytokines , d-dimer , nitric oxide , and 2,3-DPG concentrations were analyzed .
METHODS	Mann-Whitney U-test and Wilcoxon rank sum test were used to assess significance ( p < 0.05 ) .
RESULTS	Fifty-seven patients were enrolled ( CPRBC , n = 22 ; LPRBC , n = 35 ) .
RESULTS	The LPRBC group 's final interleukin 8 , tumor necrosis factor , and d-dimer concentrations were elevated compared with their pretransfusion values ( p < 0.05 ) .
RESULTS	After the second transfused units , 2,3-DPG was higher in the patients receiving CPRBCs ( p < 0.05 ) ; this difference persisted throughout the study .
RESULTS	Finally , serum protein concentrations were decreased in the transfused CPRBC units compared with LPRBC ( p < 0.01 ) .
CONCLUSIONS	CPRBC transfusions have a superior biochemical profile : an absent inflammatory response , attenuated fibrinolytic state , and increased 2,3-DPG .
CONCLUSIONS	A blood banking system using both storage techniques will offer the highest-quality products to critically injured patients virtually independent of periodic changes in donor availability and transfusion needs .
METHODS	Therapeutic study , level II .

###24330903
OBJECTIVE	To compare the efficacy and cognitive side effects of high-dose unilateral brief pulse electroconvulsive therapy ( ECT ) with those of high-dose unilateral ultrabrief pulse ECT in the treatment of major depression .
METHODS	From April 2007 until March 2011 , we conducted a prospective , double-blind , randomized multicenter trial in 3 tertiary psychiatric hospitals .
METHODS	All patients with a depressive disorder according to DSM-IV criteria were eligible .
METHODS	Depression severity was assessed with the Montgomery-Asberg Depression Rating Scale ; primary efficacy outcomes were response , defined as a score decrease 60 % from baseline , and remission , defined as a score < 10 at 2 consecutive weekly assessments .
METHODS	Total scores on the Autobiographical Memory Interview and Amsterdam Media Questionnaire were the primary outcome measures for retrograde amnesia .
METHODS	Other cognitive domains included category fluency ( semantic memory ) and letter fluency ( lexical memory ) .
METHODS	Patients received twice-weekly unilateral brief pulse ( 1.0 millisecond ) or ultrabrief pulse ( 0.3-0 .4 millisecond ) ECT 8 times seizure threshold until remission , for a maximum of 6 weeks .
RESULTS	Of the 116 patients , 75 % ( n = 87 ) completed the study .
RESULTS	Among completers , 68.4 % ( 26/58 ) of those in the brief pulse group achieved remission versus 49.0 % ( 24/49 ) of those in the ultrabrief pulse group ( P = .019 ) , and the brief pulse group needed fewer treatment sessions to achieve remission : mean ( SD ) of 7.1 ( 2.6 ) versus 9.2 ( 2.3 ) sessions ( P = .008 ) .
RESULTS	No significant group differences were found in the evaluation of the cognitive assessments .
CONCLUSIONS	The efficacy and speed of remission seen with high-dose brief pulse right unilateral ECT twice weekly were superior to those seen with high-dose ultrabrief pulse right unilateral ECT , with equal cognitive side effects as defined by retrograde amnesia , semantic memory , and lexical memory .
BACKGROUND	Netherlands National Trial Register number : NTR1304 .

###25349302
OBJECTIVE	The effects of ovarian function suppression ( OFS ) on survival and patient-reported outcomes were evaluated in a phase III trial in which premenopausal women were randomly assigned to tamoxifen with or without OFS .
METHODS	Premenopausal women with axillary node-negative , hormone receptor-positive breast cancer tumors measuring 3 cm were randomly assigned to tamoxifen alone versus tamoxifen plus OFS ; adjuvant chemotherapy was not permitted .
METHODS	Primary end points were disease-free survival ( DFS ) and overall survival ( OS ) .
METHODS	Secondary end points included toxicity and patient-reported outcomes .
METHODS	Patient-reported outcome data included health-related quality of life , menopausal symptoms , and sexual function .
METHODS	These were evaluated at baseline , 6 months , 12 months , and then annually for up to 5 years after registration .
RESULTS	In all , 345 premenopausal women were enrolled : 171 on tamoxifen alone and 174 on tamoxifen plus OFS .
RESULTS	With a median follow-up of 9.9 years , there was no significant difference between arms for DFS ( 5-year rate : 87.9 % v 89.7 % ; log-rank P = .62 ) or OS ( 5-year rate : 95.2 % v 97.6 % ; log-rank P = .67 ) .
RESULTS	Grade 3 or higher toxicity was more common in the tamoxifen plus OFS arm ( 22.4 % v 12.3 % ; P = .004 ) .
RESULTS	Patients treated with tamoxifen plus OFS had more menopausal symptoms , lower sexual activity , and inferior health-related quality of life at 3-year follow-up ( P < .01 for all ) .
RESULTS	Differences diminished with further follow-up .
CONCLUSIONS	When added to tamoxifen , OFS results in more menopausal symptoms and sexual dysfunction , which contributes to inferior self-reported health-related quality of life .
CONCLUSIONS	Because of early closure , this study is underpowered for drawing conclusions about the impact on survival when adding OFS to tamoxifen .

###25020153
OBJECTIVE	The present study examined how gain - and loss-framed informational videos about oral health influence self-reported flossing behavior over a 6-month period , as well as the roles of perceived susceptibility to oral health problems and approach/avoidance motivational orientation in moderating these effects .
METHODS	An age and ethnically diverse sample of 855 American adults were randomized to receive no health message , or either a gain-framed or loss-framed video presented on the Internet .
METHODS	Self-reported flossing was assessed longitudinally at 2 and 6 months .
RESULTS	Among the entire sample , susceptibility interacted with frame to predict flossing .
RESULTS	Participants who watched a video where the frame ( gain/loss ) matched perceived susceptibility ( low/high ) had significantly greater likelihood of flossing at recommended levels at the 6-month follow-up , compared with those who viewed a mismatched video or no video at all .
RESULTS	However , young adults ( 18-24 ) showed stronger moderation by motivational orientation than by perceived susceptibility , in line with previous work largely conducted with young adult samples .
CONCLUSIONS	Brief informational interventions can influence long-term health behavior , particularly when the gain - or loss-frame of the information matches the recipient 's beliefs about their health outcome risks .

###24240972
BACKGROUND	The aim of this study is to compare the efficacy and safety of expectant management with surgical management of first-trimester miscarriage .
METHODS	This randomised prospective study was conducted in the Gynaecology Department at University of Saarland Hospital , Germany between February 2011 and April 2012 .
METHODS	A total of 234 women were recruited following diagnosis of the first-trimester incomplete or missed miscarriage and randomised into two groups : 109 women were randomised to expectant management ( group I ) , and 125 women to surgical management ( groupII ) .
METHODS	All women were examined clinically and sonographically during the follow-up appointments at weekly intervals for up to 4 weeks as appropriate .
METHODS	The outcome measures were : efficacy , short-term complications and duration of vaginal bleeding and pain .
RESULTS	Of 234 eligible women , 17 were lost to follow-up , and the remaining 217 women were analysed .
RESULTS	The baseline characteristics were similar in both groups .
RESULTS	The total success rate at 4 weeks was lower for expectant than for surgical management ( 81.4 vs 95.7 % ; P = 0.0029 ) .
RESULTS	The type of miscarriage was a significant factor affecting the success rate .
RESULTS	For missed miscarriage , the success rates for expectant versus surgical management were 75 and 93.8 % , respectively .
RESULTS	For women with incomplete miscarriage , the rates were 90.5 and 98 % .
RESULTS	No differences were found in the number of emergency curettages between the two study groups .
RESULTS	The duration of bleeding was significantly more in the expectant than the surgical management ( mean 11 vs 7 days ; P < 0.0001 ) .
RESULTS	The duration of pain was also more in the expectant than the surgical group ( mean 8.1 vs 5.5 days ; P < 0.0001 ) .
RESULTS	The total complication rates were similar in both groups ( expectant 5.9 % vs surgical group 6.1 % ; P = 0.2479 ) .
RESULTS	However , the pelvic infection was significantly lower in the expectant than the surgical group ( 1.9 vs 3.5 % , respectively ; P = 0.0146 ) .
CONCLUSIONS	Expectant management of clinically stable women with first-trimester miscarriage is safe and effective and avoids the need for surgery and the subsequent risk of anaesthesia in about 81.4 % of cases , and has lower pelvic infection rate than surgical curettage .
CONCLUSIONS	However , surgical management is more successful , and with a shorter duration of bleeding and pain .
CONCLUSIONS	Therefore , the patient 's preference should be considered in the counselling process .

###25847558
OBJECTIVE	To examine the effectiveness of dance on motor functions , cognitive functions , and mental symptoms of Parkinson 's disease ( PD ) .
METHODS	This study employed a quasi-randomised , between-group design .
METHODS	Dance , PD exercise , and all assessments were performed in community halls in different regions of Japan .
METHODS	Forty-six mild-moderate PD patients participated .
METHODS	Six PD patient associations that agreed to participate in the study were randomly assigned to a dance group , PD exercise group , or non-intervention group .
METHODS	The dance and PD exercise groups performed one 60-min session per week for 12 weeks .
METHODS	Control group patients continued with their normal lives .
METHODS	All groups were assessed before and after the intervention .
METHODS	We used the Timed Up-and-Go Test ( TUG ) and Berg Balance Scale ( BBS ) to assess motor function , the Frontal Assessment Battery at bedside ( FAB ) and Mental Rotation Task ( MRT ) to assess cognitive function , and the Apathy Scale ( AS ) and Self-rating Depression Scale ( SDS ) to assess mental symptoms of PD .
METHODS	The Unified Parkinson 's Disease Rating Scale ( UPDRS ) was used for general assessment of PD .
RESULTS	When comparing results before and after intervention , the dance group showed a large effect in TUG time ( ES = 0.65 , p = 0.006 ) , TUG step number ( ES = 0.66 , p = 0.005 ) , BBS ( ES = 0.75 , p = 0.001 ) , FAB ( ES = 0.77 , p = 0.001 ) , MRT response time ( ES = 0.79 , p < 0.001 ) , AS ( ES = 0.78 , p < 0.001 ) , SDS ( ES = 0.66 , p = 0.006 ) and UPDRS ( ES = 0.88 , p < 0.001 ) .
CONCLUSIONS	Dance was effective in improving motor function , cognitive function , and mental symptoms in PD patients .
CONCLUSIONS	General symptoms in PD also improved .
CONCLUSIONS	Dance is an effective method for rehabilitation in PD patients .

###24245543
BACKGROUND	Ischemic mitral regurgitation is associated with a substantial risk of death .
BACKGROUND	Practice guidelines recommend surgery for patients with a severe form of this condition but acknowledge that the supporting evidence for repair or replacement is limited .
METHODS	We randomly assigned 251 patients with severe ischemic mitral regurgitation to undergo either mitral-valve repair or chordal-sparing replacement in order to evaluate efficacy and safety .
METHODS	The primary end point was the left ventricular end-systolic volume index ( LVESVI ) at 12 months , as assessed with the use of a Wilcoxon rank-sum test in which deaths were categorized below the lowest LVESVI rank .
RESULTS	At 12 months , the mean LVESVI among surviving patients was 54.625.0 ml per square meter of body-surface area in the repair group and 60.731.5 ml per square meter in the replacement group ( mean change from baseline , -6.6 and -6.8 ml per square meter , respectively ) .
RESULTS	The rate of death was 14.3 % in the repair group and 17.6 % in the replacement group ( hazard ratio with repair , 0.79 ; 95 % confidence interval , 0.42 to 1.47 ; P = 0.45 by the log-rank test ) .
RESULTS	There was no significant between-group difference in LVESVI after adjustment for death ( z score , 1.33 ; P = 0.18 ) .
RESULTS	The rate of moderate or severe recurrence of mitral regurgitation at 12 months was higher in the repair group than in the replacement group ( 32.6 % vs. 2.3 % , P < 0.001 ) .
RESULTS	There were no significant between-group differences in the rate of a composite of major adverse cardiac or cerebrovascular events , in functional status , or in quality of life at 12 months .
CONCLUSIONS	We observed no significant difference in left ventricular reverse remodeling or survival at 12 months between patients who underwent mitral-valve repair and those who underwent mitral-valve replacement .
CONCLUSIONS	Replacement provided a more durable correction of mitral regurgitation , but there was no significant between-group difference in clinical outcomes .
CONCLUSIONS	( Funded by the National Institutes of Health and the Canadian Institutes of Health ; ClinicalTrials.gov number , NCT00807040 . )

###24626851
BACKGROUND	Efficacy of available therapies for patients with HCV who have previously failed treatment is limited .
BACKGROUND	Two Phase III , open-label trials in Japan investigated efficacy and safety of simeprevir and peginterferon -- 2a/ribavirin ( PR ) combination therapy in treatment-experienced patients with genotype 1 HCV infection .
METHODS	In CONCERTO-2 , prior non-responders to IFN-based therapy ( N = 106 ) received simeprevir ( TMC435 ) 100 mg QD with PR for 12 ( SMV12 , n = 53 ) or 24 weeks ( SMV24 , n = 53 ) followed by response-guided therapy ( RGT ) with PR for 12/36 ( SMV12 ) or 0/24 ( SMV24 ) weeks .
METHODS	In CONCERTO-3 , relapsers after IFN-based therapy ( N = 49 ) received simeprevir 100 mg QD with PR for 12 weeks followed by RGT with PR for 12/36 weeks .
METHODS	Primary endpoints were the rates of sustained virologic response 12 weeks after treatment end ( SVR12 ) .
RESULTS	SVR12 rates were 52.8 % ( SMV12 ) and 35.8 % ( SMV24 ) for prior non-responders , and 95.9 % for prior relapsers ( SMV12 ; p 0.0001 vs null hypothesis , respectively ) .
RESULTS	Most prior non-responders ( SMV12 : 81.1 % ; SMV24 : 73.6 % ) and prior relapsers ( 95.9 % ) met RGT criteria and completed PR to Week 24 .
RESULTS	Of these , 60.5 % , 48.7 % , and 95.7 % , respectively , achieved SVR12 .
RESULTS	Viral breakthrough occurred in 13.2 % ( SMV12 ) and 11.3 % ( SMV24 ) of prior non-responders ; no viral breakthrough occurred in prior relapsers .
RESULTS	Viral relapse occurred in 38.6 % ( SMV12 ) and 51.1 % ( SMV24 ) of prior non-responders and 8.2 % of prior relapsers .
RESULTS	Simeprevir with PR was generally well tolerated in both studies .
CONCLUSIONS	Re-treatment with 12 weeks of simeprevir QD with PR provided high SVR in treatment-experienced patients with chronic HCV genotype 1 infection , and allowed most patients to complete treatment in 24 weeks .

###25677670
OBJECTIVE	To compare intraobserver repeatability and interobserver and intersession reproducibility of lower tear meniscus height measurements ( LTMH ) obtained with the new Keratograph 5M and a Fourier-domain optical-coherence tomography ( OCT ; Spectralis OCT ) and to assess the agreement between the two devices .
METHODS	This is a observational cross-sectional study .
METHODS	Thirty eyes of 30 normal subjects were randomly imaged twice with both devices in our setting .
METHODS	Two examiners randomly made LTMH measurements using the devices .
METHODS	To assess intraobserver repeatability and interobserver and intersession reproducibility within-subject SD ( Sw ) , test-retest repeatability , coefficient of variation ( CoV ) and intraclass correlation coefficients ( ICCs ) were calculated .
METHODS	Agreement between both devices was also determined .
RESULTS	Average LMTH for Keratograph was 235.4657.61 m , whereas the mean LTMH measured by OCT was 245.8467.18 m. Intraobserver repeatability and interobserver and intersession reproducibility were moderate with Keratograph ( CoV 0.16 % , 0.19 % , 0.17 % and ICC 0.83 , 0.76 , 0.83 , respectively ) and high for the Spectralis OCT ( CoV 0.13 % , 0.12 % , 0.11 % and ICC 0.9 , 0.92 , 0.92 , respectively ) .
RESULTS	No statistically significant difference was detected in mean LMTH measurements made with both devices , although correlation was low ( CoV 0.25 % , ICC 0.55 ) .
CONCLUSIONS	Spectralis OCT LTMH measurements were more reliable than the new Keratograph data .
CONCLUSIONS	Agreement between the devices was poor .

###25399316
OBJECTIVE	The aim of the study was to compare the effect of mefenamic acid and ginger on pain management in primary dysmenorrhea .
METHODS	One hundred and twenty-two female students with moderate to severe primary dysmenorrhea were randomly allocated to the ginger and mefenamic groups in a randomized clinical trial .
METHODS	The mefenamic group received 250 mg capsules every 8 h , and the ginger group received 250 mg capsules ( zintoma ) every 6 h from the onset of menstruation until pain relief lasted 2 cycles .
METHODS	The intensity of pain was assessed by the visual analog scale .
METHODS	Data were analyzed by descriptive statistics , t test , Chi-square , Fisher exact test and repeated measurement .
RESULTS	The pain intensity in the mefenamic and ginger group was 39.01 17.77 and 43.49 19.99 , respectively , in the first month , and 33.75 17.71 and 38.19 20.47 , respectively , in the second month ( p > 0.05 ) .
RESULTS	The severity of dysmenorrhea , pain duration , cycle duration and bleeding volume was not significantly different between groups during the study .
RESULTS	The menstrual days were more in the ginger group in the first ( p = 0.01 ) and second cycle ( p = 0.04 ) .
RESULTS	Repeated measurement showed a significant difference in pain intensity within the groups by time , but not between groups .
CONCLUSIONS	Ginger is as effective as mefenamic acid on pain relief in primary dysmenorrhea .
CONCLUSIONS	Ginger does not have adverse effects and is an alternative treatment for primary dysmenorrhea .

###25478758
OBJECTIVE	This prospective , randomized trial compared ultrasound-guided targeted intracluster injection ( TII ) supraclavicular brachial plexus block ( SCB ) and infraclavicular brachial plexus block ( ICB ) .
METHODS	Sixty-four patients were randomly allocated to receive an ultrasound-guided TII SCB ( n = 32 ) or ICB ( n = 32 ) .
METHODS	The local anesthetic agent ( lidocaine 1.5 % with epinephrine 5 g/mL ) was identical in all subjects .
METHODS	In the TII SCB group , half the volume ( 16 mL ) was injected inside the largest neural cluster ( confluence of trunks and divisions of the brachial plexus ) .
METHODS	Subsequently , the remaining half ( 16 mL ) was divided into equal aliquots and injected inside every single satellite cluster .
METHODS	In the ICB group , the entire volume ( 35 mL ) was injected dorsal to the axillary artery .
METHODS	During the performance of the block , the performance time , number of needle passes , procedural pain , and complications ( vascular puncture , paresthesia ) were recorded .
METHODS	Subsequently , a blinded observer assessed the onset time , incidence of Horner syndrome , and success rate ( surgical anesthesia ) .
METHODS	The main outcome variable was the total anesthesia-related time ( sum of performance and onset times ) .
RESULTS	Due to a quicker onset [ 8.9 ( 5.6 ) vs 17.6 ( 5.3 ) minutes ; P < 0.001 ] , the total anesthesia-related time was shorter with TII SCB [ 18.2 ( 6.1 ) vs 22.8 ( 5.3 ) minutes ; P < 0.001 ] .
RESULTS	However no differences were observed between the 2 groups in terms of success rate ( 93.7 % -96.9 % ) , block-related pain scores , and adverse events such as vascular puncture and paresthesia .
RESULTS	Expectedly , the ICB group required fewer needle passes ( 2 vs 6 ; P < 0.001 ) as well as shorter needling [ 4.8 ( 2.3 ) vs 9.0 ( 2.9 ) minutes ; P < 0.001 ] and performance [ 5.6 ( 2.3 ) vs 9.5 ( 2.9 ) minutes ; P < 0.001 ] times .
RESULTS	Moreover , the ICB approach was associated with a decreased incidence of Horner syndrome ( 3.1 % vs 53.1 % ; P < 0.001 ) .
CONCLUSIONS	Ultrasound-guided TII SCB and ICB provide comparable success rates .
CONCLUSIONS	Due to its quick onset , TII SCB results in a shorter total anesthesia-related time .

###25141907
OBJECTIVE	To evaluate the therapeutic effects of tamsulosin on recurrent urinary tract infections in women with dysfunctional voiding .
METHODS	A total of 155 women with recurrent urinary tract infections and dysfunctional voiding were included and randomly assigned to the following groups : uroflowmetry biofeedback ( group 1 ) , 1-adrenoceptor antagonists ( group 2 ) , uroflowmetry biofeedback combined with 1-adrenoceptor antagonists ( group 3 ) and no treatment ( group 4 ) .
METHODS	Patients were evaluated by the American Urological Association Symptom Index at 3 , 6 and 12 months .
METHODS	Urodynamics was carried out in patients of groups 1 , 2 , and 3 at 3 , 6 and 12 months , whereas urodynamics was only carried out at 12 months in group 4 .
METHODS	All patients were followed up for 1 year with monthly urine cultures .
RESULTS	The incidence of storage and emptying symptoms decreased significantly at 3 , 6 and 12 months .
RESULTS	Mean flow rate , flow time and voiding volume increased significantly ( with a better outcome in patients of group 3 ) , whereas post-void residual urine decreased .
RESULTS	Mean opening detrusor pressure and detrusor pressure at maximum flow decreased significantly ( with a better outcome in patients of group 3 ) .
RESULTS	Mean urethral closure pressure and maximum urethral closure pressure decreased significantly with a more significant decrease for patients in group 3 .
RESULTS	The prevalence of urinary tract infection decreased significantly in all groups after treatment , and this decrease remained stable during the follow up .
CONCLUSIONS	In women with dysfunctional voiding and recurrent urinary tract infection , tamsulosin associated with uroflowmetry biofeedback might be an effective and safe treatment option for improving urinary symptoms and quality of life .

###25702777
BACKGROUND	We conducted a prospective single-blind randomized study to assess whether a single 80,000 IU dose of human recombinant erythropoietin ( HRE ) , given just 2 days before cardiac surgery , could be effective in reducing perioperative allogeneic red blood cell transfusion ( aRBCt ) .
METHODS	Six-hundred patients presenting with preoperative hemoglobin ( Hb ) level of not more than 14.5 g/dL were randomly assigned to either HRE or control .
METHODS	The primary endpoint was the incidence of perioperative aRBCt .
METHODS	The secondary endpoints were mortality and the incidence of adverse events in the first 45 days after surgery , Hb level on Postoperative Day 4 , and number of units of RBC transfusions in the first 4 days after surgery .
RESULTS	A total of 17 % ( HRE ) versus 39 % ( control ) required transfusion ( relative risk , 0.436 ; p < 0.0005 ) .
RESULTS	After baseline Hb was controlled for , there was no difference in the incidence of aRBCt between HRE ( 0 % ) and control ( 3.5 % ) among the patients with baseline Hb of 13.0 g/dL or more , which included the nonanemic fraction of the study population .
RESULTS	The mean ( range ) Hb level on Postoperative Day 4 was 10.2 ( 9.9-10 .6 ) g/dL ( HRE ) versus 8.7 ( 8.5-9 .2 ) g/dL ( control ; p < 0.0005 ) .
RESULTS	The distribution of number of units transfused was shifted toward fewer units in HRE ( p < 0.0005 ) .
RESULTS	The all-cause mortality at 45 days was 3.00 % ( HRE ) versus 3.33 % ( control ) .
RESULTS	The 45-day adverse event rate was 4.33 % ( HRE ) versus 5.67 % ( control ; both p = NS ) .
CONCLUSIONS	In anemic patients ( Hb < 13 g/dL ) , a single high dose of HRE administered 2 days before cardiac surgery is effective in reducing the incidence of aRBCt without increasing adverse events .

###25787998
BACKGROUND	Controversy surrounds the effectiveness of dietary guidelines for cardiovascular disease ( CVD ) prevention in healthy middle-aged and older men and women .
OBJECTIVE	The objective was to compare effects on vascular and lipid CVD risk factors of following the United Kingdom dietary guidelines with a traditional British diet ( control ) .
METHODS	With the use of a parallel-designed randomized controlled trial in 165 healthy nonsmoking men and women ( aged 40-70 y ) , we measured ambulatory blood pressure ( BP ) on 5 occasions , vascular function , and CVD risk factors at baseline and during 12 wk after random assignment to treatment .
METHODS	The primary outcomes were differences between treatments in daytime ambulatory systolic BP , flow-mediated dilation , and total cholesterol/HDL cholesterol .
METHODS	Secondary outcomes were differences between treatment in carotid-to-femoral pulse wave velocity , high-sensitivity C-reactive protein , and a measure of insulin sensitivity ( Revised Quantitative Insulin Sensitivity Check Index ) .
RESULTS	Data were available on 162 participants , and adherence to the dietary advice was confirmed from dietary records and biomarkers of compliance .
RESULTS	In the dietary guidelines group ( n = 80 ) compared with control ( n = 82 ) , daytime systolic BP was 4.2 mm Hg ( 95 % CI : 1.7 , 6.6 mm Hg ; P < 0.001 ) lower , the treatment effect on flow-mediated dilation [ -0.62 % ( 95 % CI : -1.48 % , 0.24 % ) ] was not significant , the total cholesterol : HDL cholesterol ratio was 0.13 ( 95 % CI : 0 , 0.26 ; P = 0.044 ) lower , pulse wave velocity was 0.29 m/s ( 95 % CI : 0.07 , 0.52 m/s ; P = 0.011 ) lower , high-sensitivity C-reactive protein was 36 % ( 95 % CI : 7 % , 48 % ; P = 0.017 ) lower , the treatment effect on the Revised Quantitative Insulin Sensitivity Check Index [ 2 % ( 95 % CI : -2 % , 5 % ) ] was not significant , and body weight was 1.9 kg ( 95 % CI : 1.3 , 2.5 kg ; P < 0.001 ) lower .
RESULTS	Causal mediated effects analysis based on urinary sodium excretion indicated that sodium reduction explained 2.4 mm Hg ( 95 % CI : 1.0 , 3.9 mm Hg ) of the fall in blood pressure .
CONCLUSIONS	Selecting a diet consistent with current dietary guidelines lowers BP and lipids , which would be expected to reduce the risk of CVD by one-third in healthy middle-aged and older men and women .
CONCLUSIONS	This study is registered at www.isrctn.com as 92382106 .

###26055122
BACKGROUND	Preventing recurrence of depression forms an important challenge for current treatments .
BACKGROUND	Cognitive control impairments often remain present during remission of depression , putting remitted depressed patients at heightened risk for new depressive episodes by disrupting emotion regulation processes .
BACKGROUND	Importantly , research indicates that cognitive control training targeting working memory functioning shows potential in reducing maladaptive emotion regulation and depressive symptomatology in clinically depressed patients and at-risk student samples .
BACKGROUND	The current study aims to test the effectiveness of cognitive control training as a preventive intervention in a remitted depressed sample , exploring effects of cognitive control training on rumination and depressive symptomatology , along with indicators of adaptive emotion regulation and functioning .
METHODS	We present a double blind randomized controlled design .
METHODS	Remitted depressed adults will complete 10 online sessions of a cognitive control training targeting working memory functioning or a low cognitive load training ( active control condition ) over a period of 14days .
METHODS	Effects of training on primary outcome measures of rumination and depressive symptomatology will be assessed pre-post training and at three months follow-up , along with secondary outcome measure adaptive emotion regulation .
METHODS	Long-term effects of cognitive control training on broader indicators of functioning will be assessed at three months follow-up ( secondary outcome measures ) .
CONCLUSIONS	This study will provide information about the effectiveness of cognitive control training for remitted depressed adults in reducing vulnerability for depression .
CONCLUSIONS	Furthermore , this study will address key questions concerning the mechanisms underlying the effects of cognitive control training , will take into account the subjective experience of the patients ( including a self-report measure for cognitive functioning ) , and explore whether these effects extend to broad measures of functioning such as Quality of Life and disability .
BACKGROUND	This study is registered with ClinicalTrials.Gov , number NCT02407652 .

###24506910
BACKGROUND	Vitamin D levels are alarmingly low ( < 75 nmol/L ) in 65-70 % of North American children older than 1 year .
BACKGROUND	An increased risk of viral upper respiratory tract infections ( URTI ) , asthma-related hospitalizations and use of anti-inflammatory medication have all been linked with low vitamin D. No study has determined whether wintertime vitamin D supplementation can reduce the risk of URTI and asthma exacerbations , two of the most common and costly illnesses of early childhood .
BACKGROUND	The objectives of this study are : 1 ) to compare the effect of ` high dose ' ( 2000 IU/day ) vs. ` standard dose ' ( 400 IU/day ) vitamin D supplementation in achieving reductions in laboratory confirmed URTI and asthma exacerbations during the winter in preschool-aged Canadian children ; and 2 ) to assess the effect of ` high dose ' vitamin D supplementation on vitamin D serum levels and specific viruses that cause URTI .
METHODS	This study is a pragmatic randomized controlled trial .
METHODS	Over 4 successive winters we will recruit 750 healthy children 1-5 years of age .
METHODS	Participating physicians are part of a primary healthcare research network called TARGet Kids !
METHODS	Children will be randomized to the ` standard dose ' or ` high dose ' oral supplemental vitamin D for a minimum of 4 months ( 200 children per group ) .
METHODS	Parents will obtain a nasal swab from their child with each URTI , report the number of asthma exacerbations and complete symptom checklists .
METHODS	Unscheduled physician visits for URTIs and asthma exacerbations will be recorded .
METHODS	By May , a blood sample will be drawn to determine vitamin D serum levels .
METHODS	The primary analysis will be a comparison of URTI rate between study groups using a Poisson regression model .
METHODS	Secondary analyses will compare vitamin D serum levels , asthma exacerbations and the frequency of specific viral agents between groups .
CONCLUSIONS	Identifying whether vitamin D supplementation of preschoolers can reduce wintertime viral URTIs and asthma exacerbations and what dose is optimal may reduce population wide morbidity and associated health care and societal costs .
CONCLUSIONS	This information will assist in determining practice and health policy recommendations related to vitamin D supplementation in healthy Canadian preschoolers .

###24798870
OBJECTIVE	Macrophage recruitment through C-C motif chemokine receptor-2 ( CCR2 ) into adipose tissue is believed to play a role in the development of insulin resistance and type 2 diabetes mellitus ( T2DM ) .
OBJECTIVE	The objective of this Phase 2 proof-of-concept study was to evaluate the safety , tolerability , pharmacokinetics and pharmacodynamics of JNJ-41443532 , an orally bioavailable CCR2 antagonist , in patients with T2DM .
METHODS	This was a 4-week , double-blind , placebo-controlled , randomized , multicenter study .
METHODS	A total of 89 patients were randomized to receive either 250 - or 1000-mg of JNJ-41443532 twice daily , 30-mg of pioglitazone once daily ( reference arm ) , or placebo .
METHODS	The primary endpoint was change from baseline in 23-h weighted mean glucose ( WMG ) ; secondary endpoints included change from baseline in fasting plasma glucose ( FPG ) , insulin resistance ( Homeostatic Model Assessment [ HOMA-IR ] ) , insulin secretion ( HOMA - % B ) and body weight .
RESULTS	Absorption of JNJ-41443532 into the systemic circulation occurred at a median tmax of 2 h , and the mean t was approximately 8 h for both doses ; plasma systemic exposures increased slightly more than dose-proportionally .
RESULTS	After 4 weeks , reductions in 23-h WMG and FPG were observed in all treatment groups compared with placebo and were significantly lower for 250-mg JNJ-41443532 and pioglitazone .
RESULTS	HOMA-IR was lower for all treatment groups , but significantly lower only for pioglitazone .
RESULTS	Conversely , HOMA - % B was increased for all groups , but significantly increased only for 250-mg JNJ-41443532 .
RESULTS	All groups , including placebo , had decreased body weight over time .
RESULTS	There were no clinically significant findings during routine safety assessments and the incidence of treatment-emergent adverse events was similar across all groups .
CONCLUSIONS	Administration of JNJ-41443532 resulted in modest improvement in glycaemic parameters compared with placebo , and was generally well tolerated in patients with T2DM .

###25209323
BACKGROUND	Extracurricular programmes could provide a mechanism to increase the physical activity ( PA ) of primary-school-aged children .
BACKGROUND	The aim of this feasibility study was to examine whether the Action 3:30 intervention , which is delivered by teaching assistants , holds promise as a means of increasing the PA of Year 5 and 6 children .
METHODS	A cluster randomised feasibility trial was conducted in 20 primary schools .
METHODS	Ten schools received the Action 3:30 intervention and 10 schools were allocated to the control arm .
METHODS	The intervention was 40 one-hour sessions , delivered twice a week by teaching assistants .
METHODS	The proportion of participants recruited per school was calculated .
METHODS	Session delivery and session attendance was calculated for intervention schools .
METHODS	Weekday and after-school ( 3.30 to 8.30 pm ) moderate to vigorous intensity physical ( MVPA ) was assessed by accelerometer at baseline ( T0 ) , during the last few weeks of the intervention ( T1 ) and four months after the intervention had ended ( T2 ) .
METHODS	The costs of delivering the intervention were estimated .
RESULTS	Five intervention schools ran all 40 of the intended sessions .
RESULTS	Of the remaining five , three ran 39 , one ran 38 and one ran 29 sessions .
RESULTS	Mean attendance was 53 % .
RESULTS	The adjusted difference in weekday MVPA at T1 was 4.3 minutes ( 95 % CI -2.6 to 11.3 ) .
RESULTS	Sex-stratified analyses indicated that boys obtained 8.6 more minutes of weekday MVPA than the control group ( 95 % CI 2.8 to 14.5 ) at T1 with no effect for girls ( 0.15 minutes , 95 % CI -9.7 to 10.0 ) .
RESULTS	There was no evidence that participation in the programme increased MVPA once the club sessions ceased ( T2 ) .
RESULTS	The indicative average cost of this intervention was 2,425 per school or 81 per participating child during its first year and 1,461 per school or 49 per participating child thereafter .
CONCLUSIONS	The effect of the Action 3:30 intervention was comparable to previous physical activity interventions but further analysis indicated that there was a marked sex difference with a positive impact on boys and no evidence of an effect on girls .
CONCLUSIONS	The Action 3:30 intervention holds considerable promise but more work is needed to enhance the effectiveness of the intervention , particularly for girls .
BACKGROUND	ISRCTN58502739 .

###25326742
OBJECTIVE	The aim of this study was to evaluate the impact of intravascular ultrasound ( IVUS ) guidance on the final volume of contrast agent used in patients undergoing percutaneous coronary intervention ( PCI ) .
BACKGROUND	To date , few approaches have been described to reduce the final dose of contrast agent in PCIs .
BACKGROUND	We hypothesized that IVUS might serve as an alternative imaging tool to angiography in many steps during PCI , thereby reducing the use of iodine contrast .
METHODS	A total of 83 patients were randomized to angiography-guided PCI or IVUS-guided PCI ; both groups were treated according to a pre-defined meticulous procedural strategy .
METHODS	The primary endpoint was the total volume contrast agent used during PCI .
METHODS	Patients were followed clinically for an average of 4 months .
RESULTS	The median total volume of contrast was 64.5 ml ( interquartile range [ IQR ] : 42.8 to 97.0 ml ; minimum , 19 ml ; maximum , 170 ml ) in the angiography-guided group versus 20.0 ml ( IQR : 12.5 to 30.0 ml ; minimum , 3 ml ; maximum , 54ml ) in the IVUS-guided group ( p < 0.001 ) .
RESULTS	Similarly , the median volume of contrast/creatinine clearance ratio was significantly lower among patients treated with IVUS-guided PCI ( 1.0 [ IQR : 0.6 to 1.9 ] vs. 0.4 [ IQR : 0.2 to 0.6 , respectively ; p < 0.001 ) .
RESULTS	In-hospital and 4-month outcomes were not different between patients randomized to angiography-guided and IVUS-guided PCI .
CONCLUSIONS	Thoughtful and extensive use of IVUS as the primary imaging tool to guide PCI is safe and markedly reduces the volume of iodine contrast compared with angiography-alone guidance .
CONCLUSIONS	The use of IVUS should be considered for patients at high risk of contrast-induced acute kidney injury or volume overload undergoing coronary angioplasty .
CONCLUSIONS	( Minimizing cOntrast utiliZation With IVUS Guidance in coRonary angioplasTy [ MOZART ] ; NCT01947335 ) .

###24981180
OBJECTIVE	General anesthesia ( GA ) is the most commonly used anesthetic technique for spinal surgery .
OBJECTIVE	This study aimed to compare spinal anesthesia ( SA ) and GA in patients undergoing spinal surgery , in terms of perioperative outcome and cost effectiveness .
METHODS	The study included 80 patients with ASA ( American Society of Anesthesiologists ) physical status I-II .
METHODS	The patients were randomized to receive SA ( n = 40 ) or GA ( n = 40 ) .
METHODS	Heart rate ( HR ) , mean arterial blood pressure ( MABP ) , blood loss , duration of surgery , duration of anesthesia , surgeon satisfaction , and duration in the post-anesthesia care unit ( PACU ) were recorded .
METHODS	Postoperative analgesic requirement , nausea and vomiting ( PONV ) , perioperative hemodynamic variables , and anesthetic costs were determined .
RESULTS	HR and MABP were significantly higher in the GA group than in the SA group at the end of surgery and at PACU admission .
RESULTS	Duration of anesthesia , surgeon satisfaction , postoperative analgesic requirement , and anesthetic costs were significantly higher in the GA group .
RESULTS	Mean blood loss was lower in the SA group than in the GA group , but the difference was not significant .
RESULTS	Duration of surgery , duration in the PACU , perioperative hemodynamic variables , and complications were similar in both groups .
CONCLUSIONS	SA could be considered a reliable alternative to GA in patients undergoing lumber spine surgery , as it is clinically as effective as GA , but more cost effective .

###25263837
BACKGROUND	Obese men are more likely to have poor dietary patterns compared to women , increasing diet-related chronic disease risk .
BACKGROUND	The impact of a male-only weight loss intervention on dietary intakes is under-evaluated .
BACKGROUND	The aim was to determine whether overweight/obese men randomised to self-help paper-based resources with or without online support , achieved greater improvements in diet compared with Wait-list controls at 3 and 6 months following a gender tailored weight-loss intervention .
METHODS	Dietary intake was assessed using a 120-item semi-quantitative food frequency questionnaire ( FFQ ) , in a secondary analysis of a three-arm weight loss RCT grounded in Social Cognitive Theory ; ( 1 ) RESOURCES : gender-tailored weight loss resources ( DVD , handbooks , pedometer , tape measure ) ; ( 2 ) Online : resources plus website and efeedback , ( 3 ) Wait-list control .
RESULTS	Energy , total fat , saturated fat , and carbohydrate intakes decreased in the online group , which differed significantly from controls at 3 - and 6-month follow-up ( P < 0.05 ) .
RESULTS	There was a significant reduction in energy , fat and carbohydrate intakes in the Resource group at 3 and 6 months , but no difference from controls ( P > 0.05 ) .
RESULTS	In the online group there was an increase in % energy from core foods and decrease in % energy from energy-dense nutrient-poor foods ( P < 0.05 ) that was significantly different compared to controls at 3 and 6 months ( P < 0.05 ) .
CONCLUSIONS	Results suggest that men randomised to the SHED-IT intervention arms were able to implement key dietary messages up to 6 months compared to controls .
CONCLUSIONS	Future interventions should include targeted and gender-tailored messages as a strategy to improve men 's dietary intake within weight loss interventions .

###25055933
OBJECTIVE	To compare the efficacy and safety of sublingual misoprostol with intracervical dinoprostone gel for cervical ripening in prelabour rupture of membrane after 34 weeks of gestation .
METHODS	One eighty-eight women having > 34 weeks of gestation with PROM , singleton viable fetus and no prior caesarean section were randomized to sublingual misoprostol ( 50 g every 4 h and maximum of 3 doses ) and intracervical dinoprostone ( 0.5 mg every 2 h and maximum of 2 doses ) .
METHODS	Oxytocin augmentation was commenced in those with a satisfactory Bishop score , inadequate contractions and who did not go into spontaneous active labour .
METHODS	Primary outcome measures were induction-delivery interval and the number of women that went into spontaneous labour without oxytocin augmentation .
RESULTS	There was a significant reduction in induction to delivery interval in sublingual misoprostol group compared to intracervical dinoprostone ( 8.3 3.6 h vs 12.2 6.6 h ; p = 0.000 ) .
RESULTS	There was a significant reduction in duration of rupture of membrane to delivery interval ( p = 0.015 ) , 1st stage of labour ( p = 0.000 ) in sublingual misoprostol group as compared to the intravaginal dinoprostone group .
RESULTS	There was no difference observed in spontaneous vaginal delivery between the groups ( 0.919 ) .
RESULTS	Oxytocin requirement was significantly higher in the dinoprostone group p = 0.006 ) .
RESULTS	There were more maternal adverse effects of sublingual misoprostol ( p = 0.026 ) .
RESULTS	However , maternal and neonatal safety profiles were comparable .
CONCLUSIONS	Sublingual misoprostol and intracervical dinoprostone at the dose studied are equally efficacious in achieving spontaneous vaginal delivery , reduction in induction-delivery interval and in reducing the need for oxytocin , in women after 34 weeks gestation with rupture of membranes .

###24880907
OBJECTIVE	Oral nutritional supplements ( ONS ) are often considered for hospitalized patients with acute severe malnutrition , however the compliance to the supplements is known to be variable .
OBJECTIVE	The aim of our study was to investigate whether providing a lower volume of ONS at a higher frequency during medication rounds would improve the intake of the supplements .
METHODS	In this randomized controlled trial , 234 malnourished inpatients ( mean age 71.2 years , 55 % male , median LOS 10 days ) were randomized to receive ONS ( 300 kcal and 12 g Protein per 125 ml serving ) in one of three different schemes .
METHODS	The usual care group ( n = 88 ) was offered ONS 125 ml twice per day in between meals .
METHODS	This was compared to two intervention groups that were offered ONS during medication rounds : intervention group 1 ( n = 66 ) received 125 ml of ONS twice per day , at 12 and 17 o'clock , and intervention group 2 ( n = 80 ) received 62 ml of ONS four times a day , at 8 , 12 , 17 and 20 o'clock .
METHODS	Follow-up was performed until discharge or until ONS was no longer needed , with a maximum follow-up period of 30 days .
METHODS	The primary outcome measure was the percentage of patients who consumed at least 75 % of the prescribed volume of ONS .
RESULTS	No significant differences were observed between the control groups and intervention group 1 ( risk difference of -16.0 % ( 95 % CI -33.2 -1.2 ) .
RESULTS	However , the percentage of patients consuming at least 75 % of the prescribed ONS was higher in intervention group 2 , with a risk difference 23.4 % ( 95 % CI 7.8-39 .0 % ) and a mean increased intake of 35 ml ( 84 kcal ) per day , p < 0.001 ) .
RESULTS	Median time ONS were taken was 5 days ( range 1-17 ) .
CONCLUSIONS	A higher frequency of a lower volume of ONS during medication rounds increased the compliance of patients needing ONS .
CONCLUSIONS	Clinical trial registration number NTR2535 ; www.trialregister.nl .

###24418284
OBJECTIVE	To investigate whether low-dose dynamic CT of the liver with iterative reconstruction can reduce both the radiation dose and the amount of contrast medium .
METHODS	This study was approved by our institutional review board .
METHODS	113 patients were randomly assigned to one of two groups .
METHODS	Group A/group B ( fifty-eight/fifty-five patients ) underwent liver dynamic CT at 120/100 kV , with 0/40 % adaptive statistical iterative reconstruction ( ASIR ) , with a contrast dose of 600/480 mg I/kg , respectively .
METHODS	Radiation exposure was estimated based on the manufacturer 's phantom data .
METHODS	The enhancement value of the hepatic parenchyma , vessels and the tumor-to-liver contrast of hepatocellular carcinomas ( HCCs ) were compared between two groups .
METHODS	Two readers independently assessed the CT images of the hepatic parenchyma and HCCs .
RESULTS	The mean CT dose indices : 6.38 / 4.04 mGy , the dose-length products : 194.54 / 124.57 mGy cm , for group A/group B.
RESULTS	The mean enhancement value of the hepatic parenchyma and the tumor-to-liver contrast of HCCs with diameters greater than 1cm in the post-contrast all phases did not differ significantly between two groups ( P > 0.05 ) .
RESULTS	The enhancement values of vessels in group B were significantly higher than that in group A in the delayed phases ( P < 0.05 ) .
RESULTS	Two reader 's confidence levels for the hepatic parenchyma in the delayed phases and HCCs did not differ significantly between the groups ( P > 0.05 ) .
CONCLUSIONS	Low-dose dynamic CT with ASIR can reduce both the radiation dose and the amount of contrast medium without image quality degradation , compared to conventional dynamic CT without ASIR .

###25443007
BACKGROUND	Thoracoscopic wedge resection is generally accepted as a standard surgical procedure for primary spontaneous pneumothorax .
BACKGROUND	Because of the relatively high recurrence rate after surgery , additional procedures such as mechanical pleurodesis or visceral pleural coverage are usually applied to minimize recurrence , although mechanical pleurodesis has some potential disadvantages .
BACKGROUND	The aim of this study was to clarify whether an additional coverage procedure on thestaple line after thoracoscopic bullectomy prevents postoperative recurrence compared with additional pleurodesis .
METHODS	A total of 1,414 patients in 11 hospitals with primary spontaneous pneumothorax undergoing thoracoscopic bullectomy were enrolled .
METHODS	After bullectomy with staplers , patients were randomly assigned to either the coverage group ( n = 757 ) or the pleurodesis group ( n = 657 ) .
METHODS	In the coverage group , the staple line was covered with absorbable cellulose mesh and fibrin glue .
METHODS	The pleurodesis group underwent additional mechanical abrasion on the parietal pleura .
RESULTS	The coverage group and the pleurodesis group showed comparable surgical outcomes .
RESULTS	After a median follow-up of 19.5 months , the postoperative 1-year recurrence rate was 9.5 % in the coverage group and 10.7 % in the pleurodesis group .
RESULTS	The 1-year recurrence rate requiring intervention was 5.8 % in the coverage group and 7.8 % in the pleurodesis group .
RESULTS	The coverage group showed better recovery from pain .
CONCLUSIONS	In terms of postoperative recurrence rate , visceral pleural coverage after thoracoscopic bullectomy was not inferior to mechanical pleurodesis .
CONCLUSIONS	Visceral pleural coverage may potentially replace mechanical pleurodesis , which has potential disadvantages such as disturbed normal pleural physiology .

###24355447
BACKGROUND	Lung cancer ( LC ) is the most common cause of cancer death in Denmark , and triaging patients through fast-track diagnostic pathways is recommended to improve patient outcome .
BACKGROUND	Data on the most efficient triage organisation of such pathways are limited .
BACKGROUND	The aim of this study was to test a strategy of a straight-to-test model for patients referred to the fast-track pathway .
BACKGROUND	Outcomes were number of computed tomographies ( CT ) performed , use of specialist time and staff acceptability .
METHODS	We performed a randomised controlled study enrolling 493 patients who were referred from general practice to fast-track LC evaluation ( 1 January-1 December 2012 ) .
METHODS	Half of the patients were randomly assigned to the intervention and went straight to a chest CT before chest-physician evaluation .
METHODS	Time was measured for patients at random days .
METHODS	Acceptability was examined in a focus group interview .
RESULTS	In the intervention group , 95.5 % of patients had a CT performed compared with 97.2 % in the control group .
RESULTS	There was no difference in the number of CTs between the groups ( risk difference ( RD ) = 1.3 % ( 95 % confidence interval ( CI ) : 4.4-2 .0 ; p = 0.454 ) ) .
RESULTS	In the intervention group , chest-physician time was 13.3 min .
RESULTS	( min.-max. : 7.7-19 .5 min . )
RESULTS	lower per referred patient than in the control group .
CONCLUSIONS	Giving general practitioners direct access to a CT did not change the number of CTs performed and significantly reduced chest-physician time per patient .
CONCLUSIONS	In addition , the strategy was associated with high levels of staff acceptability .
BACKGROUND	The project was supported by the Danish Cancer Research Foundation , the Danish Cancer Society and the Novo Nordisk Foundation .
BACKGROUND	ClinicalTrials.gov : NCT01779726 .

###25546177
OBJECTIVE	To assess the efficacy and safety of sono-electro-magnetic therapy compared to placebo in men with refractory CPPS .
METHODS	In a randomized , placebo-controlled , double-blind single center trial , we assessed the effect of sono-electro-magnetic therapy in men with treatment refractory CPPS .
METHODS	Sixty male patients were randomly assigned to treatment with either sono-electro-magnetic ( n = 30 ) or placebo therapy ( n = 30 ) for 12 weeks .
METHODS	The primary outcome was a change in the National Institutes of Health Chronic Prostatitis Symptom Index ( NIH-CPSI ) from baseline to 12 weeks .
RESULTS	The 12-week difference between sono-electro-magnetic and placebo therapy in changes of the NIH-CPSI total score was -3.1 points ( 95 % CI -6.8 to 0.6 , p = 0.11 ) .
RESULTS	In secondary comparisons of NIH-CPSI sub-scores , we found differences between groups most pronounced for the quality-of-life sub-score ( difference at 12 weeks -1.6 , 95 % CI -2.8 to -0.4 , p = 0.015 ) .
RESULTS	In stratified analyses , the benefit of sono-electro-magnetic therapy appeared more pronounced among patients who had a symptom duration of 12 months or less ( difference in NIH-CPSI total score -8.3 , 95 % CI -14.5 to 2.6 ) than in patients with a longer symptom duration ( -0.8 , 95 % CI -4.6 to 3.1 ; p for interaction = 0.023 ) .
CONCLUSIONS	Sono-electro-magnetic therapy did not result in a significant improvement of symptoms in the overall cohort of treatment refractory CPPS patients compared to placebo treatment .
CONCLUSIONS	Subgroup analysis indicates , however , that patients with a symptom-duration of 12 months or less may benefit from sono-electro-magnetic therapy , warranting larger randomized controlled trials in this subpopulation .
BACKGROUND	ClinicalTrials.gov NCT00688506 .

###25056813
BACKGROUND	The prevalence of diabetes has been growing rapidly in developing countries .
BACKGROUND	This causes devastating economic burdens and increases demands on the health care system .
BACKGROUND	Therefore , there is an urgent need to find a cost-effective and multi-faceted approach for diabetes care .
BACKGROUND	Peer support models provide a potentially low-cost , flexible means which complements the current existing health care services .
BACKGROUND	In this way , trained peer leaders can become qualified extensions to a formal healthcare system , capable of assisting education delivery and bolstering the efforts of professional staff .
BACKGROUND	As such , creating a cultural specific peer support program and determining whether it is acceptable and cost-effective in rural communities of China is crucial .
BACKGROUND	This study aims to implement and evaluate biophysical and psychosocial outcomes of peer support program for people with type 2 diabetes in rural communities , and to explore the program 's feasibility and sustainability in China .
METHODS	This study is a cluster randomised controlled trial .
METHODS	All consenting patients will be randomised by community staff members to receive either peer support or the control care .
METHODS	The data collection and analysis including social demographics , health status , psychosocial status , economic status and biomedical measures will be collected at baseline , 6 months , and 12 months .
METHODS	The primary indicator measured is the change in HbA1c , whereas secondary indicators include biophysical , psychosocial functioning and other lifestyle factors .
METHODS	Finally , economic evaluations will determine whether the program is cost effective .
CONCLUSIONS	This protocol is a cluster randomized , controlled trial of group-based peer support for people with type 2 diabetes in the community settings of rural China .
CONCLUSIONS	Results from this trial may provide evidence to the effectiveness of peer support ; furthermore , they will provide valuable information concerning the acceptability and feasibility of a new approach to improve diabetes self-management among resource-constrained settings .
BACKGROUND	ClinicalTrials.gov Identifier : NCT02119572 , April 18 , 2014 .

###24368465
OBJECTIVE	Evidence-based treatments for posttraumatic stress disorder ( PTSD ) have not been established for adolescents despite high prevalence of PTSD in this population .
OBJECTIVE	To examine the effects of counselor-delivered prolonged exposure therapy compared with supportive counseling for adolescents with PTSD .
METHODS	A single-blind , randomized clinical trial of 61 adolescent girls with PTSD using a permuted block design .
METHODS	Counselors previously naive to prolonged exposure therapy provided the treatments in a community mental health clinic .
METHODS	Data collection lasted from February 2006 through March 2012 .
METHODS	Participants received fourteen 60 - to 90-minute sessions of prolonged exposure therapy ( n = 31 ) or supportive counseling ( n = 30 ) .
METHODS	All outcomes were assessed before treatment , at mid-treatment , and after treatment and at 3 - , 6 - , and 12-month follow-up .
METHODS	The primary outcome , PTSD symptom severity , was assessed by the Child PTSD Symptom Scale-Interview ( range , 0-51 ; higher scores indicate greater severity ) .
METHODS	Secondary outcomes were presence or absence of PTSD diagnosis assessed by the DSM-IV Schedule for Affective Disorders and Schizophrenia for School-Age Children and functioning assessed by the Children 's Global Assessment Scale ( range , 1-100 ; higher scores indicate better functioning ) .
METHODS	Additional secondary measures , PTSD severity assessed by the Child PTSD Symptom Scale-Self-Report ( range , 0-51 ; higher scores indicate greater severity ) and depression severity assessed by the Children 's Depression Inventory ( range , 0-54 ; higher scores indicate greater severity ) , were also assessed weekly during treatment .
RESULTS	Data were analyzed as intent to treat .
RESULTS	During treatment , participants receiving prolonged exposure demonstrated greater improvement on the PTSD symptom severity scale ( difference between treatments in improvement , 7.5 ; 95 % CI , 2.5-12 .5 ; P < .001 ) and on all secondary outcomes ( loss of PTSD diagnosis : difference , 29.3 % , 95 % CI , 20.2 % -41.2 % ; P = .01 ; self-reported PTSD severity : difference , 6.2 ; 95 % CI , 1.2-11 .2 ; P = .02 ; depression : difference , 4.9 ; 95 % CI , 1.6-8 .2 ; P = .008 ; global functioning : difference , 10.1 ; 95 % CI , 3.4-16 .8 ; P = .008 ) .
RESULTS	These treatment differences were maintained through the 12-month follow-up : for interviewer-assessed PTSD ( difference , 6.0 ; 95 % CI , 1.6-10 .4 ; P = .02 ) , loss of PTSD diagnosis ( difference , 31.1 ; 95 % CI , 14.7-34 .8 ; P = .01 ) , self-reported PTSD ( difference , 9.3 ; 95 % CI , 1.2-16 .5 ; P = .02 ) , depression ( difference , 7.2 ; 95 % CI , 1.4-13 .0 ; P = .02 ) , and global functioning ( difference , 11.2 ; 95 % CI , 4.5-17 .9 ; P = .01 ) .
CONCLUSIONS	Adolescents girls with sexual abuse-related PTSD experienced greater benefit from prolonged exposure therapy than from supportive counseling even when delivered by counselors who typically provide supportive counseling .
BACKGROUND	clinicaltrials.gov Identifier : NCT00417300 .

###25134530
BACKGROUND	Having shown in a recent randomized controlled trial that evidence-based patient information ( EBPI ) significantly increased knowledge on primary prevention of diabetes compared to standard patient information , we now investigated interaction between socioeconomic status ( SES ) and the effect of an EBPI .
RESULTS	1,120 visitors ( aged 40-70 years , without known diabetes ) to the `` Techniker Krankenkasse '' and the `` German Diabetes Center '' websites were randomized .
RESULTS	The intervention group received a newly developed on-line EBPI , the control group standard on-line information .
RESULTS	The primary outcome measure was knowledge , classified as `` good/average/poor '' .
RESULTS	We analyzed associations of knowledge with socioeconomic variables ( education , vocational training , employment , subjective social status ) combined with intervention effect including interactions , adjusted for possible confounding by knowledge before intervention , self-reported blood glucose measurements , blood pressure , blood lipid levels , age and gender .
RESULTS	Logistic regression models were fitted to the subpopulation ( n = 647 ) with complete values in these variables.Education ( high vs. low ) was significantly associated with knowledge ( good vs. average/poor ) ; however , there was no significant interaction between education and intervention .
RESULTS	After adjustment , the other socioeconomic variables were not significantly associated with knowledge .
CONCLUSIONS	Socioeconomic variables did not significantly change the effect of the intervention .
CONCLUSIONS	There was a tendency towards a lower effect where lower educated individuals were concerned .
CONCLUSIONS	Possibly the power was too low to detect interaction effects .
CONCLUSIONS	Larger studies using SES-specific designs are needed to clarify the effect of SES .
CONCLUSIONS	We suggest considering the socioeconomic status when evaluating a decision aid , e.g. an EBPI , to ensure its effectiveness not only in higher socioeconomic groups .
BACKGROUND	Current Controlled Trials ISRCTN22060616 ( Date assigned : 12 September 2008 ) .

###24261522
BACKGROUND	Childhood asthma is a serious and common chronic disease that requires the attention of nurses and other school personnel .
BACKGROUND	Schools are often the first setting that children take the lead in managing their asthma .
BACKGROUND	Often , children are ill prepared for this role .
BACKGROUND	Our study evaluated a school-based , multifaceted asthma program that targeted students with asthma and the broader school community .
METHODS	A randomized trial involving 130 schools with grades 1-5 and 1316 children with asthma and their families was conducted .
METHODS	Outcomes of interest for the child , at 1year , were urgent care use and school absenteeism for asthma , inhaler technique , and quality of life , and for the school , at 14months , were indicators of a supportive school environment .
RESULTS	Improvements were observed at the child and school level for the intervention group .
RESULTS	Fewer children in the intervention group had a school absence ( 50 % vs 60 % ; p < .01 ) , required urgent care for asthma ( 41 % vs 51 % ; p < .0001 ) , or reported a day of interrupted activity ( 51 % vs 63 % ; p < .01 ) , and had improved quality of life ( 5.81.2 vs 5.41.4 ; p < .0001 ) .
RESULTS	Schools in the intervention group were more likely to have practices supporting an asthma-friendly environment .
CONCLUSIONS	Implementation of a multifaceted school-based asthma program can lead to asthma-friendly schools that support children with asthma to be successful managers of their asthma and experience improved quality of life and decreased disease associated burden .

###24691452
BACKGROUND	The potential role of renal denervation ( RD ) in patients with AF and less severe hypertension is unknown .
OBJECTIVE	The purpose of this study was to assess the potential role of RD as an adjunct to pulmonary vein isolation ( PVI ) in patients with atrial fibrillation ( AF ) and moderate resistant or severe resistant hypertension .
METHODS	The data for this study were obtained from 2 different prospective randomized studies , analyzed by meta-analysis .
METHODS	Patients with paroxysmal AF or persistent AF and moderate resistant hypertension ( office blood pressure BP 140/90 mm Hg and < 160/100 mm Hg ; first study ; n = 48 ) or severe resistant hypertension ( 160/100 mm Hg ; second study ; n = 38 ) were randomized to PVI or PVI with RD. .
RESULTS	At 12 months , 26 of the 41 PVI with RD patients ( 63 % ) were AF-free vs 16 of the 39 patients ( 41 % ) in the PVI-only group ( P = .014 ) .
RESULTS	In patients with severe hypertension , 11 of the 18 PVI with RD patients ( 61 % ) vs 5 of the 18 PVI-only patients ( 28 % ) were AF-free ( P = .03 ) .
RESULTS	For moderate hypertension , the differences were less dramatic : 11 of 21 ( 52 % ) vs 15 of 23 ( 65 % ) when RD added ( P = .19 ) .
RESULTS	The superior efficacy of adding RD was most apparent in persistent AF and severe hypertension ( hazard ratio 0.25 , confidence interval 0.09-0 .72 , P = .01 ) .
RESULTS	Duration of the procedure and fluoroscopy were nonsignificantly longer in the RD group .
CONCLUSIONS	RD may improve the results of PVI in patients with persistent AF and/or severe resistant hypertension .

###26019248
BACKGROUND	The slow digestion and amino acid absorption kinetics of isolated micellar casein have been held responsible for its relatively lower postprandial muscle protein synthetic response compared with rapidly digested proteins such as isolated whey .
BACKGROUND	However , casein is normally consumed within a milk matrix .
BACKGROUND	We hypothesized that protein digestion and absorption kinetics and the subsequent muscle protein synthetic response after micellar casein ingestion are modulated by the milk matrix .
OBJECTIVE	The aim of this study was to determine the impact of a milk matrix on casein protein digestion and absorption kinetics and postprandial muscle protein synthesis in older men .
METHODS	In a parallel-group design , 32 healthy older men ( aged 71 1 y ) received a primed continuous infusion of L - [ ring - ( 2 ) H5 ] - phenylalanine , L - [ ring-3 ,5 - ( 2 ) H2 ] - tyrosine , and L - [ 1 - ( 13 ) C ] - leucine , and ingested 25 g intrinsically L - [ 1 - ( 13 ) C ] - phenylalanine and L - [ 1 - ( 13 ) C ] - leucine labeled casein dissolved in bovine milk serum ( Cas + Serum ) or water ( Cas ) .
METHODS	Plasma samples and muscle biopsies were collected in the postabsorptive state and for 300 min in the postprandial period to examine whole-body and skeletal muscle protein metabolism .
RESULTS	Casein ingestion increased plasma leucine and phenylalanine concentrations and L - [ 1 - ( 13 ) C ] - phenylalanine enrichments , with a more rapid rise after Cas vs. Cas + Serum .
RESULTS	Nonetheless , dietary protein-derived phenylalanine availability did not differ between Cas + Serum ( 47 2 % , mean SEM ) and Cas ( 46 3 % ) when assessed over the 300-min postprandial period ( P = 0.80 ) .
RESULTS	The milk matrix did not modulate postprandial myofibrillar protein synthesis rates from 0 to 120 min ( 0.038 0.005 vs. 0.031 0.007 % / h ) or from 120 to 300 min ( 0.052 0.004 vs. 0.067 0.005 % / h ) after Cas + Serum vs. Cas .
RESULTS	Similarly , no treatment differences in muscle protein-bound L - [ 1 - ( 13 ) C ] - phenylalanine enrichments were observed at 120 min ( 0.003 0.001 vs. 0.002 0.001 ) or 300 min ( 0.015 0.002 vs. 0.016 0.002 mole percent excess ) after Cas + Serum vs. Cas .
CONCLUSIONS	Casein ingestion in a milk matrix delays protein digestion and absorption but does not modulate postprandial muscle protein synthesis when compared to the ingestion of micellar casein only in healthy older men .
CONCLUSIONS	This trial was registered at Nederlands Trial Register as NTR4429 .

###26077237
OBJECTIVE	On the basis of evidence that resistance to vascular endothelial growth factor ( VEGF ) receptor inhibition is caused by hypoxia-driven residual VEGF and other proangiogenic factors , combinations of agents from these classes were hypothesized to improve treatment outcomes relative to single-agent VEGF pathway blockade .
METHODS	A total of 361 patients with metastatic clear cell renal cell carcinoma were randomly assigned equally to arm A ( bevacizumab monotherapy 10 mg/kg intravenously [ IV ] every 2 weeks ) , B ( bevacizumab 10 mg/kg IV every 2 weeks and temsirolimus 25 mg IV every week ) , C ( bevacizumab 5 mg/kg IV every 2 weeks and sorafenib 200 mg orally twice daily on days 1 to 5 , 8 to 12 , 15 to 19 , and 22 to 26 ) , or D ( sorafenib 200 mg twice daily and temsirolimus 25 mg IV weekly ) .
METHODS	Progression-free survival was the primary end point .
RESULTS	Among 331 eligible treated patients , median PFS was 7.5 months for bevacizumab alone ( 90 % CI , 5.8 to 10.8 months ) , 7.6 months for bevacizumab plus temsirolimus ( 90 % CI , 6.7 to 9.2 months ) , 9.2 months for bevacizumab plus sorafenib ( 90 % CI , 7.5 to 11.4 months ) , and 7.4 months for sorafenib plus temsirolimus ( 90 % CI , 5.6 to 7.9 months ) .
RESULTS	Hazard ratios from stratified Cox proportional hazards models were 1.01 , 0.89 , and 1.07 ( with respective P values of .95 , .49 , and .68 ) for the three combinations , respectively , compared with bevacizumab alone .
RESULTS	Adverse events did not differ significantly among treatment arms .
CONCLUSIONS	The activity of sorafenib , temsirolimus , and bevacizumab administered in doublet combinations did not significantly improve median progression-free survival in comparison with bevacizumab monotherapy .

###24702550
BACKGROUND	Full-time clinician educators are becoming more predominant in China , yet their effect is unknown .
OBJECTIVE	The purpose of this study was to compare the teaching quality of full-time ( FT ) faculty with that of part-time ( PT ) faculty in one Chinese medical school .
METHODS	In 3 consecutive years , 881 3rd year medical students were enrolled and randomly distributed into two groups , being taught by either a FT faculty member or a PT faculty member .
METHODS	Their teaching quality was evaluated with student performance on a written exam , the standardized patient exam , and student satisfaction .
RESULTS	The students in the FT group always scored better on the written exam ( 1st year = 79.82 9.2 vs. 81.26 8.2 , p < .188 ; 2nd year = 73.10 9.8 vs. 76.51 7.9 , p = .001 ; 3rd year = 75.15 9.0 vs. 79.51 8.7 , p < .0001 ) .
RESULTS	In the standardized patient exam , the students from FT groups always showed better performance in history taking and physical examination .
RESULTS	Students continually gave higher evaluations to FT faculty in questionnaires ( 1st year = 76.8 6.5 vs. 84.3 2.2 ; 2nd year = 78.6 3.9 vs. 89.7 4.2 ; 3rd year = 75.8 3.9 vs. 88.5 3.5 , all ps < .001 ) .
CONCLUSIONS	The teaching quality of FT faculty in clinical-skills training is better than PT faculty in this study .

###25317071
OBJECTIVE	Muscle loss and metabolic changes occur with disuse [ i.e. bed rest ( BR ) ] .
OBJECTIVE	We hypothesized that BR would lead to a metabolically unhealthy profile defined by : increased circulating tumor necrosis factor ( TNF ) - , decreased circulating insulin-like-growth-factor ( IGF ) -1 , decreased HDL-cholesterol , and decreased muscle density ( MD ; measured by mid-thigh computerized tomography ) .
METHODS	We investigated the metabolic profile after 28 days of BR with 8 6 % energy deficit in male individuals ( 30-55 years ) randomized to resistance exercise with amino acid supplementation ( RT , n = 24 ) or amino acid supplementation alone ( EAA , n = 7 ) .
METHODS	Upper and lower body exercises were performed in the horizontal position .
METHODS	Blood samples were taken at baseline , after 28 days of BR and 14 days of recovery .
RESULTS	We found a shift toward a metabolically unfavourable profile after BR [ compared to baseline ( BLN ) ] in both groups as shown by decreased HDL-cholesterol levels ( EAA : BLN : 39 4 vs. BR : 32 2 mg/dL , RT : BLN : 39 1 vs. BR : 32 1 mg/dL ; p < 0.001 ) and Low MD ( EAA : BLN : 27 4 vs. BR : 22 3 cm ( 2 ) , RT : BLN : 28 2 vs. BR : 23 2 cm ( 2 ) ; p < 0.001 ) .
RESULTS	A healthier metabolic profile was maintained with exercise , including NormalMD ( EAA : BLN : 124 6 vs. BR : 110 5 cm ( 2 ) , RT : BLN : 132 3 vs. BR : 131 4 cm ( 2 ) ; p < 0.001 , time-by-group ) ; although , exercise did not completely alleviate the unfavourable metabolic changes seen with BR .
RESULTS	Interestingly , both groups had increased plasma IGF-1 levels ( EAA : BLN :168 22 vs. BR 213 20 ng/mL , RT : BLN :180 10 vs. BR : 219 13 ng/mL ; p < 0.001 ) and neither group showed TNF changes ( p > 0.05 ) .
CONCLUSIONS	We conclude that RT can be incorporated to potentially offset the metabolic complications of BR .

###24400953
OBJECTIVE	The use of corticosteroids as adjunctive therapy might be effective in patients with community-acquired pneumonia ( CAP ) .
OBJECTIVE	Oral administration of dexamethasone is a practical and safer alternative to the intravenous route .
OBJECTIVE	Since patients hospitalized with pneumonia might have delayed gastric emptying , this study explored systemic exposure in terms of area under the concentration-time curve ( AUC ) of oral dexamethasone in patients hospitalized with CAP .
METHODS	In this randomized , open label study , 30 patients admitted with CAP were randomized to receive either 4mg intravenous or 6mg oral dexamethasone for 4consecutive days .
METHODS	Serial blood samples were obtained before and after drug administration .
RESULTS	Median AUC to infinity was 626gl ( -1 ) h ( IQR 401-1161 ) for the intravenous group and 774gl ( -1 ) h ( IQR 618-1146 ) for the oral group .
RESULTS	The AUC ratio of 6mg oral and 4mg intravenous dexamethasone was 1.22 ( 95 % confidence interval ( CI ) 0.81 , 1.82 ) , which represents a bioavailability of 81 % ( 95 % CI 54 , 121 ) after correction for differences in dexamethasone dose .
CONCLUSIONS	Bioavailability of oral dexamethasone in patients hospitalized with pneumonia is sufficient .
CONCLUSIONS	This makes oral dexamethasone an appropriate alternative for intravenous administration in these patients .

###24916319
BACKGROUND	Depression is a common and distressing mental health problem that is responsible for significant individual disability and cost to society .
BACKGROUND	Medication and psychological therapies are effective for treating depression and maintenance anti-depressants ( m-ADM ) can prevent relapse .
BACKGROUND	However , individuals with depression often express a wish for psychological help that can help them recover from depression in the long-term .
BACKGROUND	A recently developed treatment , mindfulness-based cognitive therapy ( MBCT ) , shows potential as a brief group program for people with recurring depression.This trial asks the policy research question ; is MBCT with support to taper/discontinue antidepressant medication ( MBCT-TS ) superior to m-ADM in terms of : a primary outcome of preventing depressive relapse/recurrence over 24 months ; and secondary outcomes of ( a ) depression free days , ( b ) residual depressive symptoms , ( c ) antidepressant medication ( ADM ) usage , ( d ) psychiatric and medical co-morbidity , ( e ) quality of life , and ( f ) cost effectiveness ?
BACKGROUND	An explanatory research question also asks whether an increase in mindfulness skills is the key mechanism of change.The design is a single-blind , parallel randomized controlled trial examining MBCT-TS versus m-ADM with an embedded process study .
BACKGROUND	To answer the main policy research question the proposed trial compares MBCT-TS with m-ADM for patients with recurrent depression .
BACKGROUND	Four hundred and twenty patients with recurrent major depressive disorder in full or partial remission will be recruited through primary care .
RESULTS	Depressive relapse/recurrence over two years is the primary outcome variable .
RESULTS	Analyses will be conducted following CONSORT standards and overseen by the trial 's Data Monitoring and Safety Committee .
RESULTS	Initial analyses will be conducted on an intention-to-treat basis , with subsequent analyses being per protocol .
RESULTS	The explanatory question will be addressed in two mutually informative ways : quantitative measurement of potential mediating variables pre - and post-treatment and a qualitative study of service users ' views and experiences .
CONCLUSIONS	If the results of our exploratory trial are extended to this definitive trial , MBCT-TS will be established as an alternative approach to maintenance antidepressants for people with a history of recurrent depression .
CONCLUSIONS	The process studies will provide evidence about the effective components which can be used to improve MBCT and inform theory as well as other therapeutic approaches .
BACKGROUND	Trial registered 7 May 2009 ; ISRCTN26666654 .

###25201587
BACKGROUND	The primary study objective was to compare the cosmetic result of radioguided seed localization ( RSL ) with wire localization ( WL ) .
METHODS	A subgroup of patients enrolled in a multicentered , randomized trial comparing WL with RSL participated .
METHODS	Frontal photographs were taken 1 and 3years postsurgery .
METHODS	The European Organization for Research and Treatment of Cancer Cosmetic Rating System was used to evaluate cosmesis outcomes by the patient and a panel of 5 raters .
RESULTS	The study enrolled 73 patients ( WL , n = 38 ; RSL , n = 35 ) .
RESULTS	Most patients rated their overall cosmesis as `` excellent '' or `` good '' ( 76 % WL , 80 % RSL ) .
RESULTS	Patient and panel ratings on all cosmetic outcomes were similar between groups .
RESULTS	Multivariable regression for overall cosmesis found larger specimen volume and reoperation to be predictors of worse ratings .
CONCLUSIONS	All cosmetic outcomes assessed were similar after WL and RSL .
CONCLUSIONS	The comparable outcomes may reflect similar reoperation rates and volumes of excision between groups .

###25122819
OBJECTIVE	To determine the effectiveness of presenting individualized colorectal cancer ( CRC ) risk information for increasing CRC screening rates in primary care patients at above-average risk of CRC .
METHODS	Randomized controlled trial .
METHODS	Georgia Regents University in Augusta-an academic family medicine clinic in the southeastern United States .
METHODS	Outpatients ( 50 to 70 years of age ) scheduled for routine visits in the family medicine clinic who were determined to be at above-average risk of CRC .
METHODS	Individualized CRC risk information calculated from the Your Disease Risk tool compared with a standard CRC screening handout .
METHODS	Intention to complete CRC screening .
METHODS	Secondary measures included the proportions of subjects completing fecal occult blood tests , flexible sigmoidoscopy , and colonoscopy .
RESULTS	A total of 1147 consecutive records were reviewed to determine eligibility .
RESULTS	Overall , 210 ( 37.7 % ) of 557 eligible participants were randomized to receive either individualized CRC risk information ( prepared by a research assistant ) or a standard CRC screening handout .
RESULTS	The intervention group had a mean ( SD ) age of 55.7 ( 4.8 ) years and the control group had a mean ( SD ) age of 55.6 ( 4.6 ) years .
RESULTS	Two-thirds of the participants in each group were female .
RESULTS	The intervention group and the control group were matched by race ( P = .40 ) .
RESULTS	There was no significant difference between groups for intention to complete CRC screening ( P = .58 ) .
RESULTS	Overall , 26.7 % of the intervention participants and 27.7 % of the control participants completed 1 or more CRC screening tests ( P = .66 ) .
CONCLUSIONS	Presentation of individualized CRC risk information by a nonphysician assistant as a decision aid did not result in higher CRC screening rates in primary care patients compared with presentation of general CRC screening information .
CONCLUSIONS	Future research is needed to determine if physician presentation of CRC risk information would result in increased screening rates compared with research assistant presentation .

###24582372
BACKGROUND	Mechanisms such as neural sensitization and maladaptive cortical organization provide novel targets for therapy in chronic recurrent low back pain ( CLBP ) .
OBJECTIVE	We investigated the effect of a transcranial direct current stimulation ( tDCS ) and peripheral electrical stimulation ( PES ) treatment on pain , cortical organization , sensitization and sensory function in CLBP .
METHODS	Using a placebo-controlled crossover design , 16 individuals received four treatments in separate sessions : ( i ) anodal tDCS/PES ; ( ii ) anodal tDCS/sham PES ; ( iii ) sham tDCS/PES ; or ( iv ) sham tDCS/sham PES .
METHODS	Pain was assessed at baseline , immediately following , and at 1 and 3 days after treatment .
METHODS	Motor cortical organization , sensitization and sensory function were measured before and immediately after treatment .
RESULTS	Combined tDCS/PES reduced pain and sensitization , normalized motor cortical organization and improved sensory function .
RESULTS	The reduction in pain was greater in individuals with more pronounced sensitization .
RESULTS	Applied alone , tDCS or PES also reduced pain .
RESULTS	However , with the exception of improved sensory function and reduced map volume following PES , clinical and neurophysiological outcomes were unaltered by tDCS or PES applied separately .
RESULTS	No changes were observed following sham treatment .
CONCLUSIONS	Our data suggest a combined tDCS/PES intervention more effectively improves CLBP symptoms and mechanisms of cortical organization and sensitization , than either intervention applied alone or a sham control .

###24250318
BACKGROUND	Subcutaneous or intrafascial wound infiltration of local anaesthetic with systemic opioids has been shown to enhance patient comfort with improved analgesia and reduced opioid requirements .
OBJECTIVE	To demonstrate improved pulmonary function when postoperative analgesia was provided by combined bupivacaine wound infiltration and systemic opioid .
METHODS	In a prospective , randomized , placebo-controlled study , 46 patients ( 23 per group ) scheduled for elective gynaecological surgery under general anaesthesia had subcutaneous and intrafascial wound infiltration of 40 ml , 0.25 % bupivacaine ( study patients ) or 40 ml 0.9 % saline ( control ) just before the end of surgery .
METHODS	Forced vital capacity ( FVC ) , forced expiratory volume in 1 second ( FEV1 ) and peak expiratory flow rate ( PEFR ) were done before surgery and at 6 , 12 and 24 hours postoperatively .
METHODS	Student 's T and chi-square tests were used for tests of significance set at P < 0.05 .
METHODS	Postoperative analgesia was provided with intramuscular morphine 0.15 mg/kg 4 hourly and 10mg/kg of intravenous paracetamol as rescue analgesia .
RESULTS	PEFR , FVC and FEV1 were reduced in both the control and study groups but the reduction was greater in the control group .
CONCLUSIONS	Bupivacaine wound infiltration produced statistically significant elevations in pulmonary function tests results at all assessment periods .

###25099866
OBJECTIVE	Lipid deposition on silicone hydrogel ( SiHy ) lenses , which are believed to be caused by their hydrophobic surface , can lead to discomfort , reduced vision , and inflammatory reactions .
OBJECTIVE	This study used a highly specific and sensitive fluorometric enzymatic assay for ex vivo cholesterol analysis of seven types of SiHy lenses : balafilcon A , comfilcon A , enfilcon A , enhanced-lotrafilcon A , enhanced-lotrafilcon B , galyfilcon A , and senofilcon A.
METHODS	Cholesterol sorption was assessed in 140 previously worn SiHy lenses from 8 clinical trials conducted in the United States and Australia between 2006 and 2008 .
METHODS	Patients wore the lenses for 2 to 4 weeks .
METHODS	Unworn negative control lenses for each lens material were obtained directly from the manufacturer .
METHODS	Lipids were isolated from the lenses using a two-step chloroform : methanol extraction method , and total cholesterol was quantified using a fluorometric enzymatic assay .
METHODS	Nonparametric Mann Whitney statistical analysis was performed to determine the differences in total cholesterol sorption between lens-specific data sets .
RESULTS	Enhanced-lotrafilcon A and enhanced-lotrafilcon B contact lenses showed significantly lower median total cholesterol sorption ( medianquartile , 0.300.2 g/lens and 0.090.1 g/lens , respectively ) than all other types of lenses that were tested ( P < 0.0001 ) .
RESULTS	By contrast , enfilcon A ( 3.960.8 g/lens ) and galyfilcon A ( 3.751.1 g/lens ) showed the highest median total cholesterol sorption of all tested lenses .
CONCLUSIONS	Cholesterol deposition in SiHy contact lenses seems to be lens polymer dependent .
CONCLUSIONS	Enhanced-lotrafilcon A and enhanced-lotrafilcon B both sorbed the lowest amount of cholesterol compared with the other five types of SiHy lenses that were tested in this study .

###24689339
OBJECTIVE	University students usually overestimate peer alcohol use , resulting in them ` drinking up ' to perceived norms .
OBJECTIVE	Social norms theory suggests correcting these inflated perceptions can reduce alcohol consumption .
OBJECTIVE	Recent findings by the current authors show portraying oneself as ' a drinker ' is considered by many students to be a socially desirable component of their Facebook identity , perpetuating an online culture that normalises binge drinking .
OBJECTIVE	However , social networking sites have yet to be utilised in social norms interventions .
METHODS	Actual and perceived descriptive and injunctive drinking norms were collected from 244 university students .
METHODS	Ninety-five students screened positive for hazardous drinking and were randomly allocated to a control group or intervention group that received social norms feedback via personalised Facebook private messages over three sessions .
RESULTS	At 1 month post-intervention , the quantity and frequency of alcohol consumed by intervention group during the previous month had significantly reduced compared with baseline and controls .
RESULTS	Reductions were maintained 3 months post-intervention .
RESULTS	Intervention group perceived drinking norms were significantly more accurate post-intervention .
CONCLUSIONS	This is the first study to test the feasibility of using Facebook to deliver social norms interventions .
CONCLUSIONS	Correcting misperceptions of peer drinking norms resulted in clinically significant reductions in alcohol use .
CONCLUSIONS	Facebook has many advantages over traditional social norms delivery , providing an innovative method for tackling problem drinking at university .
CONCLUSIONS	These results have implications for the use of Facebook to deliver positive messages about safe alcohol use to students , which may counter the negative messages regarding alcohol normally seen on Facebook .

###25238439
BACKGROUND	Randomized trials evaluating efficacy of local infiltration analgesia ( LIA ) have been published but many of these lack standardized analgesics .
BACKGROUND	There is a paucity of reports on the effects of LIA on functional capability and quality of life .
METHODS	56 patients undergoing unilateral total knee arthroplasty ( TKA ) were randomized into 2 groups in this placebo-controlled study with 12-month follow-up .
METHODS	In the LIA group , a mixture of levobupivacaine ( 150 mg ) , ketorolac ( 30 mg ) , and adrenaline ( 0.5 mg ) was infiltrated periarticularly .
METHODS	In the placebo group , infiltration contained saline .
METHODS	4 different patient-reported outcome measures ( PROMs ) were used for evaluation of functional outcome and quality of life .
RESULTS	During the first 48 hours postoperatively , patients in the LIA group used less oxycodone than patients in the placebo group in both cumulative and time-interval follow-up .
RESULTS	The effect was most significant during the first 6 postoperative hours .
RESULTS	The PROMs were similar between the groups during the 1-year follow-up .
CONCLUSIONS	Single periarticular infiltration reduced the amount of oxycodone used and enabled adequate pain management in conjunction with standardized peroral medication without adverse effects .
CONCLUSIONS	No clinically marked effects on the functional outcome after TKA were detected .

###24457184
BACKGROUND	The glomerular filtration rate ( GFR ) estimating equation incorporating both cystatin C and creatinine perform better than those using creatinine or cystatin C alone in patients with reduced GFR .
BACKGROUND	Whether this equation performs well in kidney transplant recipients cross-sectionally , and more importantly , over time has not been addressed .
METHODS	We analyzed four GFR estimating equations in participants of the Angiotensin II Blockade for Chronic Allograft Nephropathy Trial ( NCT 00067990 ) : Chronic Kidney Disease Epidemiology Collaboration equations based on serum cystatin C and creatinine ( eGFR ( CKD-EPI-Creat + CysC ) ) , cystatin C alone ( eGFR ( CKD-EPI-CysC ) ) , creatinine alone ( eGFR ( CKD-EPI-Creat ) ) and the Modification of Diet in Renal Disease study equation ( eGFR ( MDRD ) ) .
METHODS	Iothalamate GFR served as a standard ( mGFR ) .
RESULTS	mGFR , serum creatinine , and cystatin C shortly after transplant were 56.1 17.0 ml/min/1 .73 m ( 2 ) , 1.2 0.4 mg/dl , and 1.2 0.3 mg/l respectively .
RESULTS	eGFR ( CKD-EPI-Creat + CysC ) was most precise ( R ( 2 ) = 0.50 ) but slightly more biased than eGFR ( MDRD ) ; 9.0 12.7 versus 6.4 15.8 ml/min/1 .73 m ( 2 ) , respectively .
RESULTS	This improved precision was most evident in recipients with mGFR > 60 ml/min/1 .73 m ( 2 ) .
RESULTS	For relative accuracy , eGFR ( MDRD ) and eGFR ( CKD-EPI-Creat + CysC ) had the highest percentage of estimates falling within 30 % of mGFR ; 75.8 and 68.9 % , respectively .
RESULTS	Longitudinally , equations incorporating cystatin C most closely paralleled the change in mGFR .
CONCLUSIONS	eGFR ( CKD-EPI-Creat + CysC ) is more precise and reflects GFR change over time reasonably well .
CONCLUSIONS	eGFR ( MDRD ) had superior performance in recipients with mGFR between 30 and 60 ml/min/1 .73 m ( 2 ) .

###24824146
OBJECTIVE	We conducted a prospective , randomized , comparative study to compare the clinical outcome between the Trendelenburg position ureteroscopic lithotripsy ( tURSL ) and the conventional position ureteroscopic lithotripsy ( cURSL ) for the management of single proximal ureteral stone .
METHODS	From January 2012 to September 2013 , consecutive patients with single proximal ureteral calculi less than 2 cm and planned for ureteroscopic lithotripsy at our institution were enrolled in this study .
METHODS	The eligible patients were randomized into cURSL group and tURSL group according to sequence of random numbers generated by computer .
METHODS	In tURSL group , patients were turned into a Trendelenburg lithotomy position with head down 30 while the conventional lithotomy position was applied in cURSL group .
METHODS	URSL was performed using a 6/7 .5 F semi-rigid ureteroscope with holmium laser .
METHODS	When retropulsion occurred , the stones fragments were followed by semi-rigid ureteroscope up to the renal collecting system .
METHODS	The Olympus P5 flexible ureteroscope was used if there was any suspicion of stone migration into lower calices or incomplete stone fragmentation by semi-rigid ureteroscope .
METHODS	Patients ' demographics between the two groups , perioperative course , clinical outcome and complication rates were compared .
METHODS	Data were analyzed using Chi-square test , Fisher 's exact test or Student 's t test .
METHODS	Binary logistic regression analysis was applied to estimate the effects of surgical position and stone size on stone migration .
RESULTS	A total of 355 cases were finally analyzed in this study ( 176 in cURSL group and 179 in tURSL group ) .
RESULTS	The mean operative time was significantly prolonged in cURSL group than in tURSL group , while the stone-free rate ( SFR ) at 4 weeks was significantly higher in tURSL group .
RESULTS	A statistically significant difference was found in stone migration rate between the two groups ( 26.7 vs. 43.6 % , P = 0.001 ) .
RESULTS	In the stone migration subsetting , less stones fragments were found to migrate into lower calices in tURSL stone migration subgroup ( P = 0.000 ) .
RESULTS	Also , the flexible ureteroscope utilization as well as the operative time was significantly decreased in tURSL stone migration subgroup ( 25.5 vs. 72.3 % , P = 0.000 ) , ( 44.96 11.0 min vs. 59.17 9.2 min , P = 0.000 ) with higher SFR after retrograde intrarenal surgery ( RIRS ) ( 96.2 vs. 74.5 % , P = 0.000 ) .
CONCLUSIONS	The tURSL was safe and highly efficacious for the management of proximal ureteral calculus , especially in nonobese patient .
CONCLUSIONS	Even with important stone migration risk , it rendered higher SFR and less operative time compared with cURSL .
CONCLUSIONS	Moreover , less utilization of flexible ureteroscope and decreased deflection time in tURSL could potentially reduce the medical cost .

###24561057
OBJECTIVE	To investigate short-term and long-term effects of repetitive peripheral magnetic stimulation ( rpMS ) on spasticity and motor function .
METHODS	Monocentric , randomized , double-blind , sham-controlled trial .
METHODS	Neurologic rehabilitation hospital .
METHODS	Patients ( N = 66 ) with severe hemiparesis and mild to moderate spasticity resulting from a stroke or a traumatic brain injury .
METHODS	The average time SD since injury for the intervention groups was 26 71 weeks or 37 82 weeks .
METHODS	rpMS for 20 minutes or sham stimulation with subsequent occupational therapy for 20 minutes , 2 times a day , over a 2-week period .
METHODS	Modified Tardieu Scale and Fugl-Meyer Assessment ( arm score ) , assessed before therapy , at the end of the 2-week treatment period , and 2 weeks after study treatment .
METHODS	Additionally , the Tardieu Scale was assessed after the first and before the third therapy session to determine any short-term effects .
RESULTS	Spasticity ( Tardieu > 0 ) was present in 83 % of wrist flexors , 62 % of elbow flexors , 44 % of elbow extensors , and 10 % of wrist extensors .
RESULTS	Compared with the sham stimulation group , the rpMS group showed short-term effects on spasticity for wrist flexors ( P = .048 ) , and long-term effects for elbow extensors ( P < .045 ) .
RESULTS	Arm motor function ( rpMS group : median 5 [ 4-27 ] ; sham group : median 4 [ 4-9 ] ) did not significantly change over the study period in either group , whereas rpMS had a positive effect on sensory function .
CONCLUSIONS	Therapy with rpMS increases sensory function in patients with severe limb paresis .
CONCLUSIONS	The magnetic stimulation , however , has limited effect on spasticity and no effect on motor function .

###24630487
BACKGROUND	Abdominal pain is commonly reported by youth with IBD .
BACKGROUND	In a significant subset of youth , pain severity and pain catastrophizing ( i.e. , unhelpful thoughts related to the pain ) may contribute to more negative outcomes and greater impairment in functioning .
BACKGROUND	This study aimed to examine relationships of pain severity and pain catastrophizing with functional disability among a sample of youth with inflammatory bowel disease ( IBD ) .
METHODS	Seventy-five youth aged 11 to 18 years completed ratings of abdominal pain severity , pain catastrophizing , and functional disability using validated measures .
METHODS	Disease activity was rated by treating physicians .
RESULTS	Over half of participants reported abdominal pain in the past two weeks , and pain was present among those with and without clinical disease activity .
RESULTS	Nearly one-third of youth reported mild to moderate functional disability .
RESULTS	After controlling for gender , pain severity accounted for 15 % of the variance in patient functional disability .
RESULTS	Moreover , pain catastrophizing contributed significant variance to the prediction of functional disability ( approximately 7 % ) beyond the role of pain severity .
CONCLUSIONS	Greater attention to the role of pain catastrophizing in contributing to functional disability in youth with IBD may be important given that pain-related cognitions are modifiable via intervention .

###25244615
OBJECTIVE	This study attempted to clarify the mechanisms of action of fluoridated acidic liquid dentifrices against dental caries .
METHODS	In the in vitro leg , enamel specimens were submitted to a pH-cycling model , treated with distinct dentifrices ( 0 , 550 gF/g pH 4.5 and pH 7.0 , 1100 or 5000 gF/g pH 7.0 ) and analyzed using hardness .
METHODS	Alkali-soluble fluoride ( F ) deposition was quantified on pre-demineralized specimens treated with the dentifrices .
METHODS	In the clinical leg , 2-to-4-year-old children who had been using liquid dentifrices for 6 months ( 550 gF/g pH 4.5 or pH 7.0 or 1100 gF/g pH 7.0 ) had their plaque samples collected 5 and 60 min after the last brushing .
METHODS	Fluoride uptake in whole plaque was evaluated .
RESULTS	The reduction of the pH had a partial preventive effect on subsurface hardness loss only .
RESULTS	[ F ] had a significant influence on the deposition of fluoride , surface and subsurface hardness loss .
RESULTS	In vivo , the reduction of the pH was able to significantly increase plaque F uptake , leading to similar levels as those found for the neutral dentifrice containing twice [ F ] .
CONCLUSIONS	The results obtained from in vitro studies whose design does not include the presence of dental plaque should be interpreted with caution .

###24850465
OBJECTIVE	The beneficial effects of fish and n-3 polyunsaturated fatty acids ( PUFAs ) consumption on atherosclerosis have been reported in numerous epidemiological studies .
OBJECTIVE	However , to the best of our knowledge , the effects of a fish-based diet intervention on endothelial function have not been investigated .
OBJECTIVE	Therefore , we studied these effects in postmenopausal women with type 2 diabetes mellitus ( T2DM ) .
METHODS	Twenty-three postmenopausal women with T2DM were assigned to two four-week periods of either a fish-based diet ( n-3 PUFAs 3.0 g/day ) or a control diet in a randomized crossover design .
METHODS	Endothelial function was measured with reactive hyperemia using strain-gauge plethysmography and compared with the serum levels of fatty acids and their metabolites .
METHODS	Endothelial function was determined with peak forearm blood flow ( Peak ) , duration of reactive hyperemia ( Duration ) and flow debt repayment ( FDR ) .
RESULTS	A fish-based dietary intervention improved Peak by 63.7 % , Duration by 27.9 % and FDR by 70.7 % , compared to the control diet .
RESULTS	Serum n-3 PUFA levels increased after the fish-based diet period and decreased after the control diet , compared with the baseline ( 1.49 vs. 0.97 vs. 1.19 mmol/l , p < 0.0001 ) .
RESULTS	There was no correlation between serum n-3 PUFA levels and endothelial function .
RESULTS	An increased ratio of epoxyeicosatrienoic acid/dihydroxyeicosatrienoic acid was observed after a fish-based diet intervention , possibly due to the inhibition of the activity of soluble epoxide hydrolase .
CONCLUSIONS	A fish-based dietary intervention improves endothelial function in postmenopausal women with T2DM .
CONCLUSIONS	Dissociation between the serum n-3 PUFA concentration and endothelial function suggests that the other factors may contribute to this phenomenon .

###25050672
OBJECTIVE	To compare the rates of recurrence of chronic subdural hematoma following surgical evacuation by one of two methods , namely , using frontal and parietal burr holes without a drain or a single parietal burr hole with the addition of a subdural drain .
METHODS	This was a randomized controlled trial with two groups of 70 patients each .
METHODS	Patients in group I had two burr holes and those in group II had a single burr-hole .
METHODS	A subdural drain was placed for the second group , and this was removed 48-72 hours later .
METHODS	Patients were followed up for 3 months and symptomatic recurrences underwent re-exploration .
RESULTS	11 out of 70 patients in group I had recurrent hematomas requiring surgery while only two out of 70 patients in group II had symptomatic recurrences .
RESULTS	The difference was statistically significant ( p = 0.0168 ) .
CONCLUSIONS	The use of a single burr hole with drain appears to be a safe and effective procedure for the treatment of chronic subdural hematoma .

###24737062
OBJECTIVE	Effective motor imagery performance , seen as strong suppression of the sensorimotor rhythm , is the key element in motor imagery therapy .
OBJECTIVE	Therefore , optimization of methods to classify whether the subject is performing the imagery task is a prerequisite .
OBJECTIVE	An optimal classification method should have high performance accuracy and use a small number of channels .
OBJECTIVE	We investigated the additional benefit of the common spatial pattern filtering ( CSP ) to a linear discriminant analysis ( LDA ) classifier , for different channel configurations .
METHODS	Ten hemispheric acute stroke patients and 11 healthy subjects were included .
METHODS	EEGs were recorded using 60 channels .
METHODS	The classifier was trained with a motor execution task .
METHODS	For both healthy controls and patients , analysis of recordings was initially limited to 3 and 11 electrodes recording from the motor cortex area , and later repeated using 45 electrodes .
RESULTS	No significant improvement on the addition of CSP to LDA was found ( in both cases , the area under the receiving operating characteristic ( AU-ROC ) 0.70 ( acceptable ) ) .
RESULTS	We then repeated the LDA+CSP method on recordings of 45 electrodes , since the use of imagery neuronal circuits may well extend beyond the motor area .
RESULTS	AU-ROC rose to 0.90 , but no virtual ` most responsible ' electrode was observed .
RESULTS	Finally , in mild-to-moderate stroke patients we could successfully use the EEG data recorded from the healthy hemisphere to train the classifier ( AU-ROC 0.70 ) .
CONCLUSIONS	Including only the channels on the unaffected motor cortex is sufficient to train a classifier .

###24722235
BACKGROUND	Idiopathic inflammatory bowel disease ( IBD ) is a common chronic enteropathy in dogs .
BACKGROUND	There are no published studies regarding the use of probiotics in the treatment of canine IBD .
BACKGROUND	The objectives were to compare responses to treatment with either combination therapy ( prednisone and metronidazole ) or probiotic strains ( VSL # 3 ) in dogs with IBD .
RESULTS	Twenty pet dogs with a diagnosis of IBD , ten healthy pet dogs , and archived control intestinal tissues from three euthanized dogs were used in this open label study .
RESULTS	Dogs with IBD were randomized to receive either probiotic ( D-VSL # 3 , n = 10 ) or combination drug therapy ( D-CT , n = 10 ) .
RESULTS	Dogs were monitored for 60 days ( during treatment ) and re-evaluated 30 days after completing treatment .
RESULTS	The CIBDAI ( P < 0.001 ) , duodenal histology scores ( P < 0.001 ) , and CD3 + cells decreased post-treatment in both treatment groups .
RESULTS	FoxP3 + cells ( p < 0.002 ) increased in the D-VSL # 3 group after treatment but not in the D-CT group .
RESULTS	TGF - + cells increased in both groups after treatment ( P = 0.0043 ) with the magnitude of this increase being significantly greater for dogs in the D-VSL # 3 group compared to the D-CT group .
RESULTS	Changes in apical junction complex molecules occludin and claudin-2 differed depending on treatment .
RESULTS	Faecalibacterium and Turicibacter were significantly decreased in dogs with IBD at T0 , with a significant increase in Faecalibacterium abundance observed in the animals treated with VSL # 3 strains .
CONCLUSIONS	A protective effect of VSL # 3 strains was observed in dogs with IBD , with a significant decrease in clinical and histological scores and a decrease in CD3 + T-cell infiltration .
CONCLUSIONS	Protection was associated with an enhancement of regulatory T-cell markers ( FoxP3 + and TGF - + ) , specifically observed in the probiotic-treated group and not in animals receiving combination therapy .
CONCLUSIONS	A normalization of dysbiosis after long-term therapy was observed in the probiotic group .
CONCLUSIONS	Larger scale studies are warranted to evaluate the clinical efficacy of VSL # 3 in canine IBD .

###24381332
OBJECTIVE	Anaesthesia is required for catheter ablation of atrial fibrillation ( A-fib ) to achieve patient comfort and immobilization to avoid map shifts .
OBJECTIVE	This study compared the analgesic and sedative efficacies of dexmedetomidine-remifentanil with those of midazolam-remifentanil for catheter ablation of A-fib .
RESULTS	Ninety patients were randomized to receive either intermittent midazolam boluses ( 1-2 mg ) with 3.6-7 .2 g/kg/h of remifentanil ( MR group ) or dexmedetomidine 0.2-0 .7 g/kg/h after a loading dose of 1 g/kg with 1.2-2 .4 g/kg/h of remifentanil ( DR group ) .
RESULTS	The sedation level assessed by the Ramsay sedation and bispectral index scores , haemodynamic variables , pain score ( 10-point numerical scale ) , and satisfaction levels of the patients and cardiologists ( 5-point numerical scale ) were recorded .
RESULTS	The Ramsay sedation score was significantly higher , and the bispectral index score was lower in the DR group ( P < 0.001 ) compared with the MR group starting 10 min after drug administration .
RESULTS	The incidence of desaturation ( SpO2 < 90 % ) was significantly greater in the MR group compared with the DR group ( 15 vs. 1 , P < 0.001 ) .
RESULTS	The pain score was significantly lower ( 1.72 1.65 vs. 0.95 1.10 , P = 0.021 ) , and the satisfaction levels of interventionists were significantly higher ( 2.50 0.71 vs. 3.00 0.63 , P = 0.001 ) in the DR group compared with the MR group .
CONCLUSIONS	The combination of dexmedetomidine and remifentanil provided deeper sedation , less respiratory depression , better analgesia , and higher satisfaction for the interventionist during catheter ablation of A-fib compared with midazolam plus remifentanil , even at a lower dose of remifentanil .

###25958708
BACKGROUND	High frequency oscillatory ventilation ( HFOV ) is theoretically ideal for lung protective strategy ventilation ( LPSV ) in acute respiratory distress syndrome ( ARDS ) .
BACKGROUND	However , recent studies revealed unsatisfactory outcomes .
BACKGROUND	The authors conducted a study to examine this phenomenon in patients with early phase of moderate to severe ARDS .
OBJECTIVE	To evaluate the effectiveness of HFOV in patients with early phase of moderate to severe ARDS .
OBJECTIVE	The primary outcome was 30 days all-cause mortality .
METHODS	The study was a matched-case controlled clinical trial performed in the medical intensive care units , Faculty of Medicine , Siriraj Hospital .
METHODS	The authors compared HFOV with LPSV in adult patients with the early phase of ARDS who received mechanical ventilation less than 72 hours and had moderate to severe hypoxemia ( PaO/FiO2 ratio less than or equal 150 ) .
RESULTS	Between June 2010 and February 2014 , 49 patients with moderate to severe ARDS were included .
RESULTS	Fourteen patients who received HFOV were matched with 16 patients who received LPSV .
RESULTS	The 30-day mortality in HFOV group was 61.5 % ; while in control group , 50 % ( p = 0.53 ) .
RESULTS	The authors found use of higher doses of sedative drugs and muscle relaxants in HFOV group .
RESULTS	In addition , this group had high-level of mean airway pressure ( mPaw ) .
RESULTS	The presence of hemodynamic instability was not different in both groups .
CONCLUSIONS	In adult patients in the early phase of moderate to severe ARDS who received mechanical ventilation for less than 72 hours , HFOV did not decrease the 30-day mortality .
CONCLUSIONS	Thus , this support should be only a rescue therapy for refractory hypoxemia cases and in highly selected patients .

###24439465
BACKGROUND	Fluoroscopy-guided bronchoscopy is usually performed for the diagnosis of peripheral pulmonary lesions ( PPL ) , but the diagnostic yield varies widely among studies .
BACKGROUND	Endobronchial ultrasound ( EBUS ) can increase the diagnostic yield of bronchoscopic diagnosis of PPL .
OBJECTIVE	To compare the diagnostic yield of fluoroscopy-guided bronchoscopy and EBUS with fluoroscopy-guided bronchoscopy in the study of PPL .
METHODS	All patients who underwent bronchoscopy to study PPL from January 2009 to December 2012 were prospectively included .
METHODS	145 consecutive patients were randomly distributed in two groups : EBUS and fluoroscopy ( 50 patients , 71.3 8.2 years ) or fluoroscopy alone ( 95 patients , 68 10.5 years ) .
METHODS	The mean diameter of the lesions was 41.97 19.22 mm .
METHODS	Cytological brushing and transbronchial biopsies were obtained .
METHODS	All procedures were performed under fluoroscopic guidance with intravenous conscious sedation .
METHODS	EBUS was performed using an endoscopic ultrasound system equipped with a 20-MHz radial miniprobe introduced via a guide-sheath .
METHODS	Bronchoscopist , cytologist , study protocol , techniques and tools were the same throughout the whole study .
RESULTS	129 ( 89 % ) patients had malignant disease .
RESULTS	A diagnosis with bronchoscopy was established in 105 ( 72.4 % ) patients .
RESULTS	EBUS plus fluoroscopy obtained a diagnostic yield in 78 % of patients and fluoroscopy alone in 69.5 % ( non-significant ) .
RESULTS	In contrast , for lesions smaller than 30 mm , EBUS plus fluoroscopy guidance provided significantly greater diagnostic performance than fluoroscopy alone ( 90 vs. 52 % ; P = .05 ) .
CONCLUSIONS	Bronchoscopy under EBUS plus fluoroscopy guidance is a technique that has become useful for the diagnostic of LPPs , especially those smaller than 30 mm in diameter .

###25154045
BACKGROUND	The clinical benefit of inhaled antibiotics in non-cystic fibrosis bronchiectasis has not been established in randomised controlled trials .
BACKGROUND	We aimed to assess safety and efficacy of aztreonam for inhalation solution ( AZLI ) in patients with non-cystic fibrosis bronchiectasis and Gram-negative bacterial colonisation .
METHODS	AIR-BX1 and AIR-BX2 were two double-blind , multicentre , randomised , placebo-controlled phase 3 trials , which included patients aged 18 years or older who had bronchiectasis and history of positive sputum or bronchoscopic culture for target Gram-negative organisms .
METHODS	Patients were randomly assigned to receive either AZLI or placebo ( 1:1 ) .
METHODS	Randomisation was done without stratification and the code was generated by a Gilead designee .
METHODS	In both studies , two 4-week courses of AZLI 75 mg or placebo ( three-times daily ; eFlow nebulizer ) were each followed by a 4-week off-treatment period .
METHODS	Primary endpoint was change from baseline Quality of Life-Bronchiectasis Respiratory Symptoms scores ( QOL-B-RSS ) at 4 weeks .
METHODS	These trials are registered with ClinicalTrials.gov , numbers are NCT01313624 for AIR-BX1 and NCT01314716 for AIR-BX2 .
RESULTS	We recruited participants from 47 ambulatory clinics for AIR-BX1 and 65 ambulatory clinics for AIR-BX2 ; studies were done between April 25 , 2011 , and July 1 , 2013 .
RESULTS	In AIR-BX1 , of the 348 patients screened , 134 were randomly assigned to receive AZLI and 132 to receive placebo .
RESULTS	In AIR-BX2 , of the 404 patients screened , 136 were randomly assigned to receive AZLI and 138 to receive placebo .
RESULTS	The difference between AZLI and placebo for adjusted mean change from baseline QOL-B-RSS was not significant at 4 weeks ( 0.8 [ 95 % CI -3.1 to 4.7 ] , p = 0.68 ) in AIR-BX1 , but was significant ( 4.6 [ 1.1 to 8.2 ] , p = 0.011 ) in AIR-BX2 .
RESULTS	The 4.6 point difference in QOL-B-RSS after 4 weeks in AIR-BX2 was not deemed clinically significant .
RESULTS	In both studies , treatment-related adverse events were more common in the AZLI group than in the placebo group , as were discontinuations from adverse events .
RESULTS	The most commonly reported treatment-emergent adverse events were dyspnea , cough , and increased sputum .
RESULTS	Each was more common for AZLI-treated than for placebo-treated patients , but the incidences were more balanced in AIR-BX2 .
CONCLUSIONS	AZLI treatment did not provide significant clinical benefit in non-cystic fibrosis bronchiectasis , as measured by QOL-B-RSS , suggesting a continued need for placebo-controlled studies to establish the clinical benefit of inhaled antibiotics in patients with this disorder .
BACKGROUND	Gilead Sciences .

###24762381
OBJECTIVE	To evaluate a novel aqueous oxygen peroxide ( AOP ) wound therapy ( BioxyQuell ) in a multi-centre , primary care-based , randomised , double-blind , placebo-controlled , parallel-group trial , monitoring long-term healing outcomes over 12 months .
METHODS	Sixty-one patients with chronic , stable venous leg ulceration were treated with either AOP solution or sterile water placebo applied as a lavage over 2 weeks .
METHODS	The patients ' wounds were dressed weekly and assessed fortnightly over the following 6 weeks .
METHODS	Patients who completed the initial 8-week trial were invited into a 10-month follow-up trial .
METHODS	The primary endpoints of the study were wound healing at 8 weeks , 12 weeks , 6 months and 12 months , and wound size reduction during the treatment phase .
METHODS	Secondary endpoints were reductions in wound bioburden and pain .
RESULTS	Patients treated with AOP were more likely to heal at 6 months ( p = 0.014 ) and 12 months ( p = 0.006 ) , but not at 8 weeks ( p = 0.979 ) or 12 weeks ( p = 0.263 ) .
RESULTS	Patients treated with AOP had greater wound area reduction ( p = 0.015 ) , reductions in pain measured on a 100-point scale ( p = 0.001 ) and wound bioburden reduction ( p = 0.005 ) during the treatment phase .
CONCLUSIONS	The addition of AOP treatment provides substantial benefits to patients with chronic venous leg ulceration compared with current best practice .

###24998117
OBJECTIVE	This study investigated interleukin-10 and nitric oxide plasma levels following surgery to determine whether there is a correlation between these two variables and if different desflurane anesthesia flow rates influence nitric oxide and interleukin-10 concentrations in circulation .
METHODS	Forty patients between 18 and 70 years and ASA I-II physical status who were scheduled to undergo thyroidectomy were enrolled in the study .
METHODS	Patients were allocated into two groups to receive two different desflurane anesthesia flow rates : high flow ( Group HF ) and low flow ( Group LF ) .
METHODS	Blood samples were drawn at the beginning ( t0 ) and end ( t1 ) of the operation and after 24h ( t2 ) .
METHODS	Plasma interleukin-10 and nitric oxide levels were measured using an enzyme-linked-immunosorbent assay and a Griess reagents kit , respectively .
METHODS	Hemodynamic and respiratory parameters were assessed .
RESULTS	There was no statistically significant difference between the two groups with regard to interleukin-10 levels at the times of measurement .
RESULTS	Interleukin-10 levels were increased equally in both groups at times t1 and t2 compared with preoperative concentrations .
RESULTS	For both groups , nitric oxide circulating concentrations were significantly reduced at times t1 and t2 compared with preoperative concentrations .
RESULTS	However , the nitric oxide value was lower for Group HF compared to Group LF at t2 .
RESULTS	No correlation was found between the IL-10 and nitric oxide levels .
CONCLUSIONS	Clinical usage of two different flow anesthesia forms with desflurane may increase interleukin-10 levels both in Group HF and Group LF ; nitric oxide levels circulating concentrations were significantly reduced at times t1 and t2 compared with preoperative concentrations ; however , at 24h postoperatively they were higher in Group LF compared to Group HF .
CONCLUSIONS	No correlation was detected between interleukin-10 and nitric oxide levels .

###26271057
BACKGROUND	It is unclear whether achieving multiple risk factor ( RF ) goals through protocol-guided intensive medical therapy is feasible or improves outcomes in type 2 diabetes mellitus .
OBJECTIVE	This study sought to quantify the relationship between achieved RF goals in the BARI 2D ( Bypass Angioplasty Investigation Revascularization 2 Diabetes ) trial and cardiovascular events/survival .
METHODS	We performed a nonrandomized analysis of survival/cardiovascular events and control of 6 RFs ( no smoking , non-high-density lipoprotein cholesterol < 130 mg/dl , triglycerides < 150 mg/dl , blood pressure [ systolic < 130 mmHg ; diastolic < 80 mmHg ] , glycosylated hemoglobin < 7 % ) in BARI 2D .
METHODS	Cox models with time-varying number of RFs in control were adjusted for baseline number of RFs in control , clinical characteristics , and trial randomization assignments .
RESULTS	In 2,265 patients ( mean age 62 years , 29 % women ) followed up for 5 years , the mean SD number of RFs in control improved from 3.5 1.4 at baseline to 4.2 1.3 at 5 years ( p < 0.0001 ) .
RESULTS	The number of RFs in control during the trial was strongly related to death ( global p = 0.0010 ) and the composite of death , myocardial infarction , and stroke ( global p = 0.0035 ) in fully adjusted models .
RESULTS	Participants with 0 to 2 RFs in control during follow-up had a 2-fold higher risk of death ( hazard ratio : 2.0 ; 95 % confidence interval : 1.3 to 3.3 ; p = 0.0031 ) and a 1.7-fold higher risk of the composite endpoint ( hazard ratio : 1.7 ; 95 % confidence interval : 1.2 to 2.5 ; p = 0.0043 ) , compared with those with 6 RFs in control .
CONCLUSIONS	Simultaneous control of multiple RFs through protocol-guided intensive medical therapy is feasible and relates to cardiovascular morbidity and mortality in patients with coronary disease and type 2 diabetes mellitus .
CONCLUSIONS	( Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes [ BARI 2D ] ; NCT00006305 ) .

###26317257
BACKGROUND	The objective of this prospective multicenter cohort study was to characterise the use of pharmacological and non-pharmacological treatment for cardiovascular disease ( CVD ) risk factors and intermittent claudication ( IC ) symptoms in clinical practice patients with peripheral artery disease ( PAD ) , and to determine the care gap with international guidelines and evidence-based therapy .
METHODS	From 2011 through 2013 , participating centres enrolled consecutive patients with PAD of atherosclerotic , origin demonstrated by ultrasound , ankle brachial index ( ABI ) < 0.9 and symptoms of IC .
METHODS	A seven item grid was built for the assessment of care gap ( percentage of patients eligible for a treatment who did not receive it ) .
METHODS	cerebrovascular disease or at least two CVD risk factors .
METHODS	Care gap was lower than 25 % for any method to stop smoking , lipid lowering agents , antiplatelet and/or anticoagulation therapy and any kind of exercise program ; between 25 % and 50 % for ACE inhibitors / angiotensin II antagonist therapy ; between 50 % and 75 % for beta-blocker therapy ; and higher than 75 % for supervised exercise program and use of cilostazol .
METHODS	Patients with and without CADI cerebrovascular disease were differently treated with clopidogrel ( 27.3 % and 4.8 % , p < 0.001 ) , any antiplatelet/anticoagulant therapy ( 98.7 % and 83.3 % , p < 0.001 ) and beta-blockers ( 46.8 % and 16.0 % , p < 0.001 ) .
RESULTS	All patients ( 232 ) presented at least one CVC risk factor , 90.2 % at least two , and 91.5 % had either established CAD or
CONCLUSIONS	Many gaps with evidence-based recommendations are still present in the pattern of the use of pharmacological and non-pharmacological treatment for CVD risk factors and IC symptoms in clinical practice PAD patients .

###25531677
BACKGROUND	This study applied a pharmacodynamic model-based approach to evaluate the long-term durability and glycemic control of pioglitazone in comparison with other oral glucose-lowering drugs in Japanese type 2 diabetes mellitus ( T2DM ) patients .
METHODS	Japanese T2DM patients were enrolled in a prospective , randomized , open-label , blinded-end point study and received pioglitazone with or without other oral glucose-lowering drugs ( excluding another thiazolidinedione [ TZD ] ) ( n = 293 ) or oral glucose-lowering drugs excluding TZD ( n = 294 ) .
METHODS	Treatment was adjusted to achieve glycosylated hemoglobin ( HbA1c ) < 6.9 % , and samples for fasting plasma glucose ( FPG ) and HbA1c were collected over 2.5-4 years .
METHODS	A simultaneous cascading indirect response model structure was applied to describe the time course of FPG and HbA1c .
METHODS	HbA1c levels were described using both an FPG-dependent and an FPG-independent function .
METHODS	To account for titration , drug effects for both treatment groups were implemented using a time-dependent Emax model .
RESULTS	Pioglitazone was superior in both time to maximum effect and the magnitude of reduction achieved in FPG and HbA1c .
RESULTS	A greater reduction in median FPG ( -21 mg/dL vs. -9 mg/dL ) was observed with pioglitazone ( P < 0.05 ) .
RESULTS	Maximum drug effect for FPG was predicted to occur earlier ( 11 months ) for pioglitazone than for the control group ( 14 months ) .
RESULTS	The simulated additional reduction in FPG and HbA1c achieved with pioglitazone was predicted to be maintained beyond the currently observed study duration .
CONCLUSIONS	Pioglitazone was found to result in improved glycemic control and durability compared with control treatment .
CONCLUSIONS	This model-based approach enabled the quantification of differences in FPG and HbA1c for both treatment groups and simulation to evaluate longer-term durability on FPG and HbA1c .

###25348346
BACKGROUND	The integrated treatment of first episode psychosis has been shown to improve functionality and negative symptoms in previous studies .
BACKGROUND	In this paper , we describe a study of integrated treatment ( individual psychoeducation complementary to pharmacotherapy ) versus treatment as usual , comparing results at baseline with those at 6-month re-assessment ( at the end of the study ) for these patients , and online training of professionals to provide this complementary treatment , with the following objectives : 1 ) to compare the efficacy of individual psychoeducation as add-on treatment versus treatment as usual in improving psychotic and mood symptoms ; 2 ) to compare adherence to medication , functioning , insight , social response , quality of life , and brain-derived neurotrophic factor , between both groups ; and 3 ) to analyse the efficacy of online training of psychotherapists .
METHODS	This is a single-blind randomised clinical trial including patients with first episode psychosis from hospitals across Spain , randomly assigned to either a control group with pharmacotherapy and regular sessions with their psychiatrist ( treatment as usual ) or an intervention group with integrated care including treatment as usual plus a psychoeducational intervention ( 14 sessions ) .
METHODS	Training for professionals involved at each participating centre was provided by the coordinating centre ( University Hospital of lava ) through video conferences .
METHODS	Patients are evaluated with an extensive battery of tests assessing clinical and sociodemographic characteristics ( Positive and Negative Syndrome Scale , State-Trait Anxiety Inventory , Liebowitz Social Anxiety Scale , Hamilton Rating Scale for Depression , Scale to Assess Unawareness of Mental Disorders , Strauss and Carpenter Prognostic Scale , Global Assessment of Functioning Scale , Morisky Green Adherence Scale , Functioning Assessment Short Test , World Health Organization Quality of Life instrument WHOQOL-BREF ( an abbreviated version of the WHOQOL-100 ) , and EuroQoL questionnaire ) , and brain-derived neurotrophic factor levels are measured in peripheral blood at baseline and at 6 months .
METHODS	The statistical analysis , including bivariate analysis , linear and logistic regression models , will be performed using SPSS .
CONCLUSIONS	This is an innovative study that includes the assessment of an integrated intervention for patients with first episode psychosis provided by professionals who are trained online , potentially making it possible to offer the intervention to more patients .
BACKGROUND	NCT01783457 clinical trials.gov .
BACKGROUND	Date of registration in primary registry 23 January 2013 .

###25359121
OBJECTIVE	Heavy episodic drinking ( HED ) is a serious problem among college women at high-risk for developing eating disorders ( EDs ) .
OBJECTIVE	The main objectives of this study are to determine the relationship of the self-rating of the effects of alcohol ( SRE ) questionnaire and HED over time , and to determine the effects of relationship breakups on HED among college-aged women at high-risk for EDs .
METHODS	Data collected from 163 participants in a randomized controlled trial evaluating the effectiveness of an ED prevention program were used in the analyses .
METHODS	Measures included the SRE , obtained at baseline , and self-reports of the number of HED episodes and relationship breakups each month for the past 12 months .
RESULTS	Generalized linear mixed-effect regression models with Poisson distribution were conducted to test the effects of several variables on reported HED episodes over 12 months .
RESULTS	Analyses demonstrated that SRE scores and the presence of a breakup predicted increased HED over time .
CONCLUSIONS	The SRE may be useful in identifying individuals at risk of or with EDs who are at increased risk of HED .
CONCLUSIONS	Furthermore , relationship breakups predict HED .
CONCLUSIONS	Findings from the current study could be used to inform clinical interventions for this population .

###24664228
OBJECTIVE	The aim of this study was to compare the Ilizarov circular fixator ( IL ) and locked intramedullary nailing ( IM ) .
METHODS	Patients with isolated tibia shaft fractures were randomly allocated to either the IL ( n = 31 ) or IM ( n = 27 ) method .
METHODS	Conventional radiographs , postoperative pain assessment , self-appraisal scores and complications were evaluated .
METHODS	At the clinical 1-year follow-up , the patients were also evaluated by an independent observer .
RESULTS	The minority of patients had open fractures , two and nine patients in the IM and IL groups , respectively .
RESULTS	Eight patients in the IM group and four in the IL group sustained major complications ( p = 0.107 ) .
RESULTS	In the IM group , two patients developed compartment syndrome , one deep infection , one hardware failure , one delayed union , one pseudarthrosis and two had a malunion .
RESULTS	In the IL group , two patients developed pseudarthrosis and two had a malunion .
RESULTS	Superficial pin-site infections were observed in 16 patients in the IL group .
RESULTS	The fractures had healed radiographically at 12 weeks in both groups .
RESULTS	At the 1-year follow-up , there were differences in pain ( VAS ) and satisfaction ( VAS ) scores in favor of IL treatment ( VAS , p = 0.03 and p = 0.02 , respectively ) .
RESULTS	There were no differences between the groups with regard to range of motion ( ROM ) in the knee and ankle joints .
RESULTS	The registration of local tenderness and pain revealed that there were 19 patients with anterior knee pain in the IM group and one in the IL group at the 1-year follow-up ( p < 0.001 ) .
CONCLUSIONS	The IL is a safe and reliable alternative to IM for the treatment of tibial shaft fractures , with a low complication rate and good clinical outcome .
CONCLUSIONS	Both treatments were well tolerated , but at the 1-year follow-up the patients in the IM group had more pain and were less satisfied .
CONCLUSIONS	Finally , there was a high frequency of anterior knee pain in the IM group .

###24594863
OBJECTIVE	The objective of this study was to evaluate whether increased serum 25-hydroxyvitamin D3 ( 25OHD3 ) concentrations , in response to calcium/vitamin D ( CaD ) supplementation , are associated with improved lipids in postmenopausal women .
METHODS	The parent trial was a double-blind , randomized , placebo-controlled , parallel-group trial designed to test the effects of CaD supplementation ( 1,000 mg of elemental calcium + 400 IU of vitamin D3 daily ) versus placebo in postmenopausal women .
METHODS	Women from the general community , including multiple sites in the United States , were enrolled between 1993 and 1998 .
METHODS	This cohort included 300 white , 200 African-American , and 100 Hispanic participants who were randomly selected from the Women 's Health Initiative CaD trial .
METHODS	Serum 25OHD3 and lipid ( fasting plasma triglycerides [ TG ] , high-density lipoprotein cholesterol [ HDL-C ] , and calculated low-density lipoprotein cholesterol [ LDL-C ] ) levels were assessed before and after CaD randomization .
RESULTS	There was a 38 % increase in mean serum 25OHD3 concentrations after 2 years ( 95 % CI , 1.29-1 .47 , P < 0.001 ) for women randomized to CaD ( 24.3 ng/mL postrandomization mean ) compared with placebo ( 18.2 ng/mL ) .
RESULTS	Women randomized to CaD had a 4.46-mg / dL mean decrease in LDL-C ( P = 0.03 ) .
RESULTS	Higher concentrations of 25OHD3 were associated with higher HDL-C levels ( P = 0.003 ) , along with lower LDL-C and TG levels ( P = 0.02 and P < 0.001 , respectively ) .
CONCLUSIONS	Supplemental CaD significantly increases 25OHD3 concentrations and decreases LDL-C .
CONCLUSIONS	Women with higher 25OHD3 concentrations have more favorable lipid profiles , including increased HDL-C , lower LDL-C , and lower TG .
CONCLUSIONS	These results support the hypothesis that higher concentrations of 25OHD3 , in response to CaD supplementation , are associated with improved LDL-C .

###25315383
OBJECTIVE	To compare the effectiveness of expectant management versus methotrexate in selected cases of tubal ectopic pregnancy .
METHODS	A double-blind randomized trial included 23 selected patients with a confirmed diagnosis of tubal pregnancy who met the inclusion criteria ( hemodynamic stability , initial serum - hCG concentration < 2,000 mIU/mL , declining titers of - hCG 48 h prior to treatment , visible tubal pregnancy on transvaginal ultrasound , a tubal mass < 5.0 cm and fertility desire ) .
METHODS	The patients were divided into two groups : 10 patients in the methotrexate group ( MTX 50 mg/m ( 2 ) administered as a single intramuscular dose ) and 13 patients in the placebo group ( saline solution administered in a single intramuscular dose ) .
METHODS	Quantitative variables were expressed as means standard deviations and compared by Student 's t test or Mann-Whitney test .
METHODS	Dichotomous variables ( success/treatment failure ) were presented as proportions and compared by the Fisher exact test .
RESULTS	Successful treatment with negative titers of - hCG occurred in 9 cases ( 90.0 % ) of the methotrexate group and in 12 ( 92.3 % ) of the placebo group ( p > 0.999 ) .
RESULTS	The - hCG values became undetectable at 22 15.4 days in the methotrexate group and 20.6 8.4 days in the placebo group ( p = 0.80 ) .
CONCLUSIONS	This study showed no statistically significant difference between the treatment with methotrexate and placebo , with similar success rates and similar time interval for - hCG to become undetectable .

###24258313
BACKGROUND	To compare intermittent treatment ( IT ) versus continuous treatment ( CT ) using cyproterone acetate ( CPA ) in bone metastatic prostate cancer patients , we conducted an open-label , multicenter randomized trial .
BACKGROUND	Continuous androgen deprivation therapy is the standard treatment in metastatic prostate cancer .
BACKGROUND	Intermittent treatment might maintain efficacy while toxicity and costs are reduced .
METHODS	Patients received CPA 100 mg tid in the prephase .
METHODS	Patients with a PSA decline of 90 % or PSA < 4 ng/ml were randomized .
METHODS	If patients were progressive , LHRH analogues were added .
METHODS	Primary end point was time to PSA progression .
RESULTS	A total of 366 patients were recruited ; 258 reached a good response after 3 or 6 months and were randomized .
RESULTS	A total of 131 patients randomized to IT and 127 to CT. .
RESULTS	Patients on IT had an average of 1.7 episodes on CPA , before LHRH analogues were started .
RESULTS	The mean time without treatment in IT was 463 days versus 422 days on treatment .
RESULTS	There were statistical significant differences between IT and CT in 3 of the 5 functional scales of EORTC QLQ C 30 ; however , the clinical relevance of this finding appears modest .
RESULTS	Symptom and potency scales showed significant advantages for IT .
RESULTS	There were no differences in time to PSA progression on CPA , time to PSA and/or clinical progression on LHRH analogues and time to cancer-specific and overall survival .
CONCLUSIONS	IT by CPA is associated with less symptoms and modest advantages in QOL domains .
CONCLUSIONS	There were no differences in time to PSA progression , clinical progression or survival .

###24235952
BACKGROUND	Nausea and vomiting are frequently seen in patients undergoing cesarean section ( CS ) under regional anesthesia .
BACKGROUND	We aimed to compare the antiemetic efficacy of ondansetron and dexamethasone combination with that of the use of each agent alone to decrease the incidence of post-delivery intraoperative nausea and vomiting ( IONV ) during CS under spinal anesthesia .
OBJECTIVE	To compare the antiemetic efficacy of ondansetron and dexamethasone combination with that of the single use of each agent to decrease the incidence of postdelivery IONV during CS under spinal anesthesia .
METHODS	A randomized , prospective , double blind study was performed on 90 patients undergoing planned CS under spinal anesthesia .
METHODS	Patients received 4mg ondansetron in Group O , 8mg dexamethasone in GroupD , 4mg ondansetron +8 mg dexamethasone in Group OD intravenously within 1-2 minutes after the umbilical cord was clamped .
METHODS	Frequency of postdelivery IONV episodes was recorded .
RESULTS	A total of 86 eligible patients were included in the study .
RESULTS	There were 29 patients in Group O , 29 patients in Group D and 28 patients in Group OD .
RESULTS	There were no statistically significant difference between the groups in terms of baseline characteristics and intraoperative managements .
RESULTS	Frequency of intraoperative nausea , retching and vomiting experiences were similar between the groups ( p > 0.05 ) .
CONCLUSIONS	Single dose 4mg ondansetron , 8mg dexamethasone , or combined use of 8mg dexamethasone +4 mg ondansetron , given intravenously is all effective agents for the control of postdelivery IONV .
CONCLUSIONS	Combined use of dexamethasone and ondansetron for the same indication does not seem to increase the antiemetic efficacy .

###24351803
BACKGROUND	We hypothesized increasing obstructive sleep apnea ( OSA ) severity would be associated with nondipping blood pressure ( BP ) in increased cardiovascular disease ( CVD ) risk .
METHODS	Baseline data from 298 cardiology patients recruited for a multicenter randomized controlled trial were examined .
METHODS	Dipping was defined as a sleep-related BP or heart rate ( HR ) reduction of at least 10 % .
METHODS	Logistic regression models were fit , adjusting for age , sex , race , BMI , CVD risk factors , CVD , and study site .
RESULTS	There was a statistically significant 4 % increase in the odds of nondipping SBP per 1-unit increase in both apnea hypopnea index ( AHI ) and oxygen desaturation index ( ODI ) .
RESULTS	There was no significant relationship between AHI and nondipping mean arterial pressure ( MAP ) ; however , a 3 % increase in the odds of nondipping MAP per 1-unit increase in ODI was observed [ odds ratio ( OR ) = 1.03 ; 95 % confidence interval ( CI ) 1.00-1 .05 ] .
RESULTS	At severe OSA levels , a 10 and 4 % increase in odds of nondipping DBP per 1-unit increase in AHI and ODI were observed , respectively .
RESULTS	A 6 % [ OR = 1.06 ; 95 % CI ( 1.01-1 .10 ) ] increase in nondipping HR odds was observed with each increase in ODI until the upper quartile of ODI .
CONCLUSIONS	In patients at cardiovascular risk and moderate-to-severe OSA , increasing AHI and/or ODI were associated with increased odds of nondipping SBP and nondipping MAP .
CONCLUSIONS	More severe levels of AHI and ODI also were associated with nondipping DBP .
CONCLUSIONS	These results support progressive BP burden associated with increased OSA severity even in patients managed by cardiology specialty care .

###25342618
OBJECTIVE	In patients with retinitis pigmentosa ( RP ) , the inner segment ellipsoid zone ( EZ ; also known as the inner segment/outer segment [ IS/OS ] border ) is a marker of the usable visual field at a given point in time and of the progression of the disease over time .
OBJECTIVE	Here we compare the change in the width per year of the EZ band in patients with autosomal dominant ( ad ) and x-linked ( xl ) RP .
METHODS	Using optical coherence tomography ( OCT ) , 9-mm horizontal and vertical line scans through the fovea were obtained for one eye of 26 xlRP patients and 33 adRP patients .
METHODS	Scans were repeated on average 2.0 years later ( range , 0.6-4 .8 years ) .
METHODS	Using a manual segmentation procedure , the EZ band was delineated and its horizontal width ( HW ) and vertical width ( VW ) were determined .
RESULTS	The adRP and xlRP patients had similar initial EZ HW ( xlRP : 11.8 5.4 , adRP : 12.4 6.3 , P = 0.69 ) and VW ( xlRP : 8.5 4.9 , adRP : 11.4 7.1 , P = 0.09 ) .
RESULTS	However , between visits the absolute loss and percent loss of the EZ width per year was significantly greater for xlRP than adRP for both HW ( xlRP : 1.0 0.6 / y , 9.6 5.6 % / y ; adRP : 0.4 0.5 / y , 3.4 5.4 % / y ; P < 0.001 ) and VW ( xlRP : 0.8 0.8 / y , 9.2 8.9 % / y ; adRP : 0.3 0.5 / y , 4.2 6.4 % / y ; P < 0.01 ) .
RESULTS	There was a weak correlation between the loss of EZ width per year and the initial width for xlRP ( r ( 2 ) = 0.17 , P = 0.036 ) , but no correlation for adRP ( r ( 2 ) = 0.004 , P = 0.73 ) .
RESULTS	The test-retest difference of EZ HW was 0.2 0.5 .
CONCLUSIONS	The OCT data here support a faster rate of loss per year in the case of xlRP .
CONCLUSIONS	( ClinicalTrials.gov number , NCT00100230 . )

###25457977
OBJECTIVE	The purpose of this study was to compare manipulative therapy ( MT ) plus rehabilitation to rehabilitation alone for recurrent ankle sprain with functional instability ( RASFI ) to determine short-term outcomes .
METHODS	This was an assessor-blind , parallel-group randomized comparative trial .
METHODS	Thirty-three eligible participants with RASFI were randomly allocated to receive rehabilitation alone or chiropractic MT plus rehabilitation .
METHODS	All participants undertook a daily rehabilitation program over the course of the 4-week treatment period .
METHODS	The participants receiving MT had 6 treatments over the same treatment period .
METHODS	The primary outcome measures were the Foot and Ankle Disability Index and the visual analogue pain scale , with the secondary outcome measure being joint motion palpation .
METHODS	Data were collected at baseline and during week 5 .
METHODS	Missing scores were replaced using a multiple imputation method .
METHODS	Statistical analysis of the data composed of repeated-measures analysis of variance .
RESULTS	Between-group analysis demonstrated a difference in scores at the final consultation for the visual analogue scale and frequency of joint motion restrictions ( P .006 ) but not for the Foot and Ankle Disability Index ( P = .26 ) .
CONCLUSIONS	This study showed that the patients with RASFI who received chiropractic MT plus rehabilitation showed significant short-term reduction in pain and the number of joint restrictions in the short-term but not disability when compared with rehabilitation alone .

###25052080
BACKGROUND	No validated patient-reported outcome ( PRO ) measure exists for functional dyspepsia ( FD ) assessment .
BACKGROUND	Verbal descriptions of different upper abdominal symptoms may be poorly distinguishable to patients .
OBJECTIVE	To investigate whether understanding of FD symptoms is enhanced by pictograms symbolising the nature of the symptoms , besides verbal descriptors .
METHODS	Consecutive FD patients were randomised to fill out a questionnaire assessing nineupper gastrointestinal symptoms ( post-prandial fullness , early satiation , epigastric pain , epigastric burning , bloating centred in the upper abdomen , nausea , vomiting , heartburn , regurgitation ) with or without accompanying pictograms .
METHODS	Symptoms were rated for frequency and severity ( 0-5 ) , and patients also identified the most bothersome symptom .
METHODS	Subsequently , in-depth history was taken by an expert clinician , who filled out the same symptom ratings .
METHODS	Concordance between patient and clinician ratings was quantified using chi-square and kappa statistics .
RESULTS	Content validity of pictograms was first confirmed by 15 FD patients .
RESULTS	Next , 76 patients ( 52 women , age 42.21.9 ) were randomised to questionnaires with or without pictograms .
RESULTS	The concordance with clinician 's assessment as gold standard rose from 36 without to 48 % for questions with pictograms ( P < 0.0001 ) .
RESULTS	Considering the Rome III subdivision , benefit in concordance with pictograms was present for post-prandial distress , epigastric pain syndrome and reflux symptoms .
RESULTS	Kappa statistics confirmed these gains ( weighted kappa values for concordance of symptom frequency ratings rose from 0.214 to 0.446 with pictograms ) , and also showed better concordance of the most bothersome symptom with pictograms .
CONCLUSIONS	Pictograms accompanying verbal descriptors significantly improve concordance of functional dyspepsia symptom ratings by patients with evaluation by their physicians .

###25068207
BACKGROUND	Non-cellulose dried matrix spotting ( DMS ) cards are an alternative to filter paper ( FP ) for bloodspots .
BACKGROUND	We compared the interpatient distributions of bloodspot areas between DMS and FP for a fixed volume of application of whole blood , and examined correlations of areas with hematocrit .
METHODS	EDTA-whole blood adult patient samples ( n = 49 ; 25 males , 24 females ) were utilized after routine measurement of hemoglobin and hematocrit .
METHODS	Replicate ( 4 ) bloodspots were produced by bolus drop application of 50L whole blood via a fixed-volume pipettor to either FP or DMS .
METHODS	Dried bloodspot areas were determined by image analysis .
RESULTS	Hematocrits ( HCT ) were normally distributed ( HCT = 30.95.3 % ) .
RESULTS	For both FP and DMS , bloodspot areas ( a , cm ( 2 ) ) across patients were normally distributed : for FP , a = 1.110.056 cm ( 2 ) ( 5.0 % ) ; for DMS , a = 0.3780.037 cm ( 2 ) ( 9.9 % ) .
RESULTS	Relative bloodspot area differences across the population range were > 20 % for both DMS and FP .
RESULTS	Correlation of bloodspot areas to hematocrit was negative for FP ( r = -0.80 ) but positive for DMS ( r = +0.78 ) .
CONCLUSIONS	Interpatient variation in blood volume per area is a preanalytical variable for both DMS and FP bloodspots .
CONCLUSIONS	Hematocrit is but one interpatient variable , as correlations of fixed-volume bloodspot areas with hematocrit across patients were substantially inexact ( r ( 2 ) < 0.65 ) .

###24475026
BACKGROUND	We explored the theorized upregulation of platelet-activating factor ( PAF ) - mediated biologic responses following lipoprotein-associated phospholipase A2 ( Lp-PLA2 ) inhibition using human platelet aggregation studies in an in vitro experiment and in 2 clinical trials .
RESULTS	Full platelet aggregation concentration response curves were generated in vitro to several platelet agonists in human plasma samples pretreated with rilapladib ( selective Lp-PLA2 inhibitor ) or vehicle .
RESULTS	This was followed by a randomized , double-blind crossover study in healthy adult men ( n = 26 ) employing a single-agonist dose assay of platelet aggregation , after treatment of subjects with 250 mg oral rilapladib or placebo once daily for 14 days .
RESULTS	This study was followed by a second randomized , double-blind parallel-group trial in healthy adult men ( n = 58 ) also treated with 250 mg oral rilapladib or placebo once daily for 14 days using a full range of 10 collagen concentrations ( 0-10 g/ml ) for characterizing EC50 values for platelet aggregation for each subject .
RESULTS	Both clinical studies were conducted at the GlaxoSmithKline Medicines Research Unit in the Prince of Wales Hospital , Sydney , Australia .
RESULTS	EC50 values derived from multiple agonist concentrations were compared and no pro-aggregant signals were observed during exposure to rilapladib in any of these platelet studies , despite Lp-PLA2 inhibition exceeding 90 % .
RESULTS	An increase in collagen-mediated aggregation was observed 3 weeks post drug termination in the crossover study ( 15.4 % vs baseline ; 95 % confidence interval [ CI ] , 3.9-27 .0 ) , which was not observed during the treatment phase and was not observed in the parallel-group study employing a more robust EC50 examination .
CONCLUSIONS	Lp-PLA2 inhibition does not enhance platelet aggregation .
BACKGROUND	1 ) Study 1 : ClinicalTrials.gov NCT01745458 2 ) Study 2 : ClinicalTrials.gov NCT00387257 .

###24866357
OBJECTIVE	To evaluate the benefits of home-based pulmonary rehabilitation ( PR ) in patients with severe and very severe chronic obstructive pulmonary disease ( COPD ) .
METHODS	Randomized clinical trial involving 58 patients .
METHODS	Pulmonary function , quality of life evaluated by the Saint George Respiratory Questionnaire , breathlessness evaluated by the London Chest Activity of Daily Living Scale , and exercise tolerance evaluated by 6-minute walk distance were assessed at baseline and at 12 weeks .
METHODS	The program consisted of 2 weekly visits by a physiotherapist in the first 2 weeks , followed by visits twice a month , as well as weekly telephone calls .
METHODS	Training included breathing and stretching exercises and strength exercises ( upper and lower limbs ) , along with endurance training , including walking , stair climbing , cycling , and treadmill walking , depending on available patient resources .
RESULTS	The treatment group ( TG ; n = 23 ) and control group ( CG ; n = 18 ) completed the study .
RESULTS	Following the intervention , no statistically significant differences were found in pulmonary function in the TG and CG .
RESULTS	The TG exhibited statistically significant differences in the activity domain ( P = .008 ) , impact domain ( P < .001 ) , and total scores of the Saint George Respiratory Questionnaire ( P < .001 ) .
RESULTS	In addition , the TG demonstrated statistically significant differences in all domains of the London Chest Activity of Daily Living Scale and no differences were observed in the CG after 12 weeks .
RESULTS	There was a statistically significant difference in the 6-Minute Walk Distance in the TG after rehabilitation ( P = .008 ) .
CONCLUSIONS	This study offers evidence that home-based PR promotes benefits in the quality of life , breathlessness in activities of daily living , and exercise capacity in patients with severe and very severe COPD .
CONCLUSIONS	Home-based PR must be considered as part of the treatment for patients who live far from hospitals even in severe COPD .

###24706022
BACKGROUND	Two of the more common methods of pain management after TKA are peripheral nerve blocks and intraarticular/periarticular injections .
BACKGROUND	However , we are not aware of any study directly comparing the commonly used combination of a continuous femoral block given with a single-shot sciatic block with that of a periarticular injection after TKA .
OBJECTIVE	This randomized clinical trial compared a combined femoral and sciatic nerve block with periarticular injection as part of a multimodal pain protocol after total knee arthroplasty with respect to ( 1 ) pain ; ( 2 ) narcotic use ; ( 3 ) quadriceps function and length of stay ; and ( 4 ) peripheral nerve complications .
METHODS	One hundred sixty patients completed randomization into two treatment arms : ( 1 ) peripheral nerve blocks ( PNB ; n = 79 ) with an indwelling femoral nerve catheter and a single shot sciatic block ; or ( 2 ) periarticular injection ( PAI ; n = 81 ) using ropivacaine , epinephrine , ketorolac , and morphine .
METHODS	All patients received standardized general anesthesia and oral medications .
METHODS	The primary outcome was postoperative pain , on a 0 to 10 scale , measured on the afternoon of postoperative day 1 ( POD 1 ) .
METHODS	Secondary outcomes were narcotic use , quadriceps function , length of stay , and peripheral nerve complications .
RESULTS	Mean pain scores on the afternoon of POD 1 were not different between groups ( PNB group : 2.9 [ SD 2.4 ] ; PAI group : 3.0 [ SD 2.2 ] ; 95 % confidence interval , -0.8 to 0.6 ; p = 0.76 ) .
RESULTS	Mean pain scores taken at three times points on POD 1 were also similar between groups .
RESULTS	Hospital length of stay was shorter for the PAI group ( 2.44 days [ SD 0.65 ] versus 2.84 days [ SD 1.34 ] for the PNB group ; p = 0.02 ) .
RESULTS	Narcotic consumption was higher the day of surgery for the PAI group ( PAI group : 11.7 mg morphine equivalents [ SD 13.1 ] ; PNB group : 4.6 mg [ SD 9.1 ] ; p < 0.001 ) , but thereafter , there was no difference .
RESULTS	More patients in the PNB group had sequelae of peripheral nerve injury ( mainly dysesthesia ) at 6-week followup ( nine [ 12 % ] versus one [ 1 % ] ; p = 0.009 ) .
CONCLUSIONS	Patients receiving periarticular injections had similar pain scores , shorter lengths of stay , less likelihood of peripheral nerve dysesthesia , but greater narcotic use on the day of surgery compared with patients receiving peripheral nerve blocks .
CONCLUSIONS	Periarticular injections provide adequate pain relief , are simple to use , and avoid the potential complications associated with nerve blocks .
METHODS	Level I , therapeutic study .
METHODS	See Guidelines for Authors for a complete description of levels of evidence .

###25896832
BACKGROUND	Acute otorrhea is a common problem in children with tympanostomy tubes .
BACKGROUND	We recently demonstrated that treatment with antibiotic-glucocorticoid eardrops is clinically superior to oral antibiotics and initial observation .
BACKGROUND	The aim of this study was to assess the cost-effectiveness of these three common treatment strategies for this condition .
METHODS	We performed an open-label pragmatic trial in which 230 children with acute uncomplicated tympanostomy-tube otorrhea were randomly allocated to receive 1 of 3 treatments : hydrocortisone-bacitracin-colistin eardrops , oral amoxicillin-clavulanate suspension , and initial observation ( no assigned medication prescription to fill ) .
METHODS	Parents kept a daily diary capturing ear-related symptoms , health care resource use , and non-health care costs for 6 months .
METHODS	At 2 weeks and 6 months , the study doctor visited the children at home performing otoscopy .
METHODS	Using a societal perspective , treatment failure ( otoscopic presence of otorrhea at 2 weeks ) and number of days with otorrhea as reported in the daily diary were balanced against the costs .
RESULTS	Antibiotic-glucocorticoid eardrops were clinically superior to oral antibiotics and initial observation both at 2 weeks and 6 months .
RESULTS	At 2 weeks , mean total cost per patient was US$ 42.43 for antibiotic-glucocorticoid eardrops , US$ 70.60 for oral antibiotics , and US$ 82.03 for initial observation .
RESULTS	At 6 months , mean total cost per patient was US$ 368.20 , US$ 420.73 , and US$ 640.44 , respectively .
RESULTS	Because of the dominance of eardrops , calculating incremental cost-effectiveness ratios was redundant .
CONCLUSIONS	Antibiotic-glucocorticoid eardrops are clinically superior and cost less than oral antibiotics and initial observation in children with tympanostomy tubes who develop otorrhea .

###25775052
OBJECTIVE	The safety and efficacy of bivalirudin compared with heparin with or without glycoprotein IIb/IIIa inhibitors in patients with acute myocardial infarction ( AMI ) undergoing primary percutaneous coronary intervention ( PCI ) are uncertain .
OBJECTIVE	To determine if bivalirudin is superior to heparin alone and to heparin plus tirofiban during primary PCI .
METHODS	Multicenter , open-label trial involving 2194 patients with AMI undergoing primary PCI at 82 centers in China between August 2012 and June 2013 .
METHODS	Patients were randomly assigned to receive bivalirudin with a post-PCI infusion ( n = 735 ) , heparin alone ( n = 729 ) , or heparin plus tirofiban with a post-PCI infusion ( n = 730 ) .
METHODS	Among patients treated with bivalirudin , a postprocedure 1.75 mg/kg/h infusion was administered for a median of 180 minutes ( IQR , 148-240 minutes ) .
METHODS	The primary end point was 30-day net adverse clinical events , a composite of major adverse cardiac or cerebral events ( all-cause death , reinfarction , ischemia-driven target vessel revascularization , or stroke ) or bleeding .
METHODS	Additional prespecified safety end points included the rates of acquired thrombocytopenia at 30 days , and stent thrombosis at 30 days and 1 year .
RESULTS	Net adverse clinical events at 30 days occurred in 65 patients ( 8.8 % ) of 735 who were treated with bivalirudin compared with 96 patients ( 13.2 % ) of 729 treated with heparin ( relative risk [ RR ] , 0.67 ; 95 % CI , 0.50-0 .90 ; difference , -4.3 % , 95 % CI , -7.5 % to -1.1 % ; P = .008 ) ; and 124 patients ( 17.0 % ) of 730 treated with heparin plus tirofiban ( RR for bivalirudin vs heparin plus tirofiban , 0.52 ; 95 % CI , 0.39-0 .69 ; difference , -8.1 % , 95 % CI , -11.6 % to -4.7 % ; P < .001 ) .
RESULTS	The 30-day bleeding rate was 4.1 % for bivalirudin , 7.5 % for heparin , and 12.3 % for heparin plus tirofiban ( P < .001 ) .
RESULTS	There were no statistically significant differences between treatments in the 30-day rates of major adverse cardiac or cerebral events ( 5.0 % for bivalirudin , 5.8 % for heparin , and 4.9 % for heparin plus tirofiban , P = .74 ) , stent thrombosis ( 0.6 % vs 0.9 % vs 0.7 % , respectively , P = .77 ) , acquired thrombocytopenia ( 0.1 % vs 0.7 % vs 1.1 % ; P = .07 ) , or in acute ( < 24-hour ) stent thrombosis ( 0.3 % in each group ) .
RESULTS	At the 1-year follow-up , the results remained similar .
CONCLUSIONS	Among patients with AMI undergoing primary PCI , the use of bivalirudin with a median 3-hour postprocedure PCI-dose infusion resulted in a decrease in net adverse clinical events compared with both heparin alone and heparin plus tirofiban .
CONCLUSIONS	This finding was primarily due to a reduction in bleeding events with bivalirudin , without significant differences in major adverse cardiac or cerebral events or stent thrombosis .
BACKGROUND	clinicaltrials.gov Identifier : NCT01696110 .

###24561149
OBJECTIVE	This study sought to examine sex-specific differences in outcomes after surgical aortic valve replacement ( SAVR ) or transcatheter aortic valve replacement ( TAVR ) in high-risk patients with severe aortic stenosis .
BACKGROUND	The PARTNER ( Placement of Aortic Transcatheter Valve ) trial demonstrated similar 2-year survival with SAVR or TAVR for high-risk patients , but sex-specific outcomes are unknown .
METHODS	In all , 699 patients ( 300 female ) were randomly assigned 1:1 to either SAVR or TAVR with a balloon expandable pericardial tissue valve .
METHODS	Baseline characteristics and 2-year outcomes of TAVR versus SAVR were compared among males and females .
RESULTS	Baseline characteristics differed between the sexes .
RESULTS	Despite higher Society of Thoracic Surgeons mortality risk scores ( 11.9 vs. 11.6 ; p = 0.05 ) , female patients had lower prevalence of coronary artery disease ( 64.4 % vs. 83.7 % ) , prior coronary artery bypass graft surgery ( 19.8 % vs. 61.2 % ) , peripheral vascular disease ( 36.4 % vs. 46.9 % ) , diabetes mellitus ( 35.6 % vs. 45.6 % ) , and elevated creatinine ( 11.7 % vs. 23.9 % ) .
RESULTS	Among female patients , procedural mortality trended lower with TAVR versus SAVR ( 6.8 % vs. 13.1 % ; p = 0.07 ) and was maintained throughout follow-up ( hazard ratio [ HR ] : 0.67 ; 95 % confidence interval [ CI ] : 0.44 to 1.00 ; p = 0.049 ) , driven by the transfemoral arm ( HR : 0.55 ; 95 % CI : 0.32 to 0.93 ; p = 0.02 ) .
RESULTS	Among male patients , although procedural mortality was lower with TAVR ( 6 % vs. 12.1 % ; p = 0.03 ) , there was no overall survival benefit ( HR : 1.15 ; 95 % CI : 0.82 to 1.61 ; p = 0.42 ) .
CONCLUSIONS	In this retrospective subanalysis of high-risk , symptomatic aortic stenosis patients in the PARTNER trial , female subjects had lower late mortality with TAVR versus SAVR .
CONCLUSIONS	This was especially true among patients suitable for transfemoral access and suggests that TAVR may be preferred over surgery for high-risk female patients .
CONCLUSIONS	A randomized , controlled trial conducted specifically in female patients is necessary to properly study differences in mortality between treatment modalities .
CONCLUSIONS	( THE PARTNER TRIAL : Placement of AoRTic TraNscathetER Valve Trial ; NCT00530894 ) .

###26016823
BACKGROUND	Cardiovascular disease is a major cause of morbidity and mortality in patients with chronic obstructive pulmonary disease ( COPD ) .
BACKGROUND	Preliminary studies have shown that both airflow obstruction and systemic inflammation may contribute to endothelial dysfunction in COPD .
BACKGROUND	Lung volume reduction surgery ( LVRS ) is a treatment option in selected patients with COPD with emphysema that improves breathing mechanics and lung function .
OBJECTIVE	To determine the effect of LVRS on endothelial function and systemic inflammation .
METHODS	We conducted a randomized controlled trial in 30 patients scheduled for LVRS .
METHODS	In the intervention group , immediate LVRS was performed after baseline evaluation followed by reassessment 3 months later .
METHODS	In the control group , reassessment followed 3 months after baseline evaluation , and thereafter LVRS was performed .
RESULTS	The primary outcome measures were the treatment effect on endothelial function and systemic inflammation .
RESULTS	In the LVRS group 14 patients completed the trial and 13 in the control group .
RESULTS	LVRS led to a relative reduction in mean ( SD ) residual volume/total lung capacity of -12 % ( 12 % ) and an increase in FEV1 of 29 % ( 27 % ) .
RESULTS	Flow-mediated dilatation of the brachial artery increased in the intervention group as compared with the control group ( +2.9 % ; 95 % confidence interval , +2.1 to +3.6 % ; P < 0.001 ) , whereas there was no significant change in systemic inflammation .
RESULTS	A significant treatment effect on mean blood pressure was observed ( -9.0 mm Hg ; 95 % confidence interval , -17.5 to -0.5 ; P = 0.039 ) .
CONCLUSIONS	Endothelial function and blood pressure are improved 3 months after LVRS in patients with severe COPD and emphysema .
CONCLUSIONS	LVRS may therefore have beneficial effects on cardiovascular outcomes .
CONCLUSIONS	Clinical trial registered with www.clinicaltrials.gov ( NCT 01020344 ) .

###24732752
OBJECTIVE	The addition of fluvastatin significantly improves sustained virological response ( SVR ) in pegylated interferon and ribavirin ( peg-IFN/RBV ) combination therapy for patients infected with the hepatitis C virus .
OBJECTIVE	However , the add-on effect on telaprevir-based triple combination therapy remains unknown .
OBJECTIVE	The aim of this study was to investigate the effect of fluvastatin on telaprevir-based combination therapy by conducting a prospective , open-label , randomized , controlled trial .
METHODS	Among 124 genotype 1b-infected chronic hepatitis C patients recruited , 116 eligible patients were allocated randomly to two study arms ; they received 12 weeks of telaprevir/peg-IFN/RBV , followed by 12 weeks of peg-IFN/RBV with or without 24 weeks of fluvastatin ( fluvastatin group and control group , respectively ) .
METHODS	Treatment outcomes and adverse effects were compared between the two groups .
RESULTS	There were 56 men and 60 women , median age 60 years ( range , 28-71 years ) .
RESULTS	Rapid virological response and end of treatment response rates were 87.9 % ( 51/58 ) and 96.6 % ( 56/58 ) in the control group and 75.9 % ( 44/58 ) and 98.3 % ( 57/58 ) in the fluvastatin group , respectively .
RESULTS	SVR rates in the control group and the fluvastatin group were 84.5 % ( 49/58 ) and 81.0 % ( 47/58 ) , respectively ; there was no significant difference ( P = 0.806 ) .
RESULTS	Stratified analysis showed that no factors associated with the SVR rate were found between the two groups .
RESULTS	No adverse events were associated with fluvastatin .
CONCLUSIONS	In this trial , administration of fluvastatin with telaprevir/peg-IFN/RBV was a safe combination .
CONCLUSIONS	However , fluvastatin had no add-on effect on 24-week telaprevir-based combination therapy for chronic hepatitis C genotype 1b-infected patients .

###25052587
BACKGROUND	Weight loss is a common problem in patients with Squamous Cell Carcinoma of the Head and Neck ( SCCHN ) treated with radiotherapy ( RT ) .
BACKGROUND	The aims of the present study were to determine if treated volume ( TV ) , as a measure of the radiation dose burden , can predict weight loss in patients with oropharyngeal cancer and to analyze weight loss and body mass index ( BMI ) in the same patient group in relation to 5-year overall survival .
METHODS	The ARTSCAN trial is a prospective , randomized , multicenter trial in patients with SCCHN .
METHODS	Nutritional data from the ARTSCAN trial were analyzed retrospectively using univariate and multivariate statistical methods based on information on percentage weight loss from the start of RT up to five months after the termination of RT ( study cohort 1 , n = 232 ) and information on patients ' BMI at the start of RT ( study cohort 2 , n = 203 ) .
METHODS	TV was defined as the volume of the patient receiving at least 95 % of the prescribed dose .
METHODS	TV64 .6 Gy encompasses macroscopic tumor and TV43 .7 Gy elective lymph nodes of the neck .
RESULTS	TV64 .6 Gy and TV43 .7 Gy were both significantly correlated with higher weight loss up to five months after the termination of RT in study cohort 1 ( p < 0.001 for both ) .
RESULTS	BMI at the start of RT was shown to be a prognostic factor for 5-year overall survival in study cohort 2 but weight loss was not .
RESULTS	The hazard ratios and 95 % confidence intervals were 3.78 ( 1.46-9 .75 ) and 2.57 ( 1.43-4 .62 ) in patients with underweight and normal weight , respectively .
CONCLUSIONS	TV can predict weight loss during RT in patients with oropharyngeal cancer regardless of clinical stage .
CONCLUSIONS	A high BMI ( > 25 kg/m2 ) at the start of RT is positively associated with survival in patients with oropharyngeal cancer .

###25768712
OBJECTIVE	This study was conducted to observe the effect of a structured educational program on drug adherence and self-care management in people with epilepsy in a developing country .
METHODS	A total of 180 consecutive people with epilepsy were enrolled from the epilepsy clinic of a tertiary care hospital in North India .
METHODS	Out of these , 90 were randomized to the epilepsy health education group and received the educational program and 90 were in the control group and received the standard of care but did not receive any structured educational program .
METHODS	The modified Morisky Medication Adherence Scale ( MMAS ) and Epilepsy Self-Efficacy Scale ( ESES ) were administered to assess drug adherence and self-care , respectively , on the day of enrollment .
METHODS	The patients enrolled in the epilepsy health education group received 4 sessions of the structured educational program .
METHODS	The MMAS and ESES questionnaires were again administered to both groups after 6months .
METHODS	Continuous and categorical variables were compared between control and epilepsy health education groups using a chi-square test , with p value less than 0.05 considered significant .
METHODS	A comparison between pretest and posttest MMAS scores and ESES scores was done using a paired t-test .
RESULTS	In the epilepsy health education group , the pretest mean MMAS score was 6.58 whereas the posttest mean MMAS score was 7.53 ; the difference was significant ( p = 0.001 ) .
RESULTS	The mean MMAS scores for the control group 's pretest and posttest were 6.46 and 6.58 , respectively , which were not significantly different ( p = 0.224 ) .
RESULTS	On comparing the ESES scores at the beginning of the study and after 6months , there was no significant change in both groups .
CONCLUSIONS	The present study proves the efficacy of a structured educational program in improving drug adherence in a cohort of people with epilepsy with low educational background .

###25986854
OBJECTIVE	The objective of this study was to determine the effects of axillary lymph node dissection ( ALND ) versus sentinel lymph node biopsy alone ( SLNB ) on the survival of patients with 3 or more metastatic lymph nodes ( MLN ) in invasive breast cancer .
METHODS	Data of 9521 patients with invasive T1-2M0 breast carcinoma and initial treatment with SLNB completed or not by ALND and 3 or more MLN were extracted from the SEER database .
METHODS	Univariate and multivariate analyses were performed .
RESULTS	Overall , 9521 patients were included in the study .
RESULTS	SLNB-alone compared with ALND did not result in different overall survival ( OS ) or specific survival ( SS ) for patients with 3 or more MLN ( p = 0.46 and 0.58 , respectively ) .
RESULTS	In subgroup analyses , OS was comparable between SLNB-alone and ALND when patients had only 3 or more than 3 MLN .
RESULTS	When patients had 3 MLN , the 5-year SS was significantly better for patients with ALND compared with SLNB-alone : 91.5 % and 85.1 % , respectively ( p = 0.02 ) .
RESULTS	The Hazard Ratio ( HR ) for OS comparing SLNB-alone with ALND adjusting for age , adjuvant radiotherapy , tumor size , estrogen receptor status , grade and tumor type resulted in an HR of 1.05 ( 95 % CI , 0.72-1 .54 , p = 0.77 ) .
CONCLUSIONS	In conclusion , patients with a T1-T2 invasive breast cancer and at least 3 MLN do not benefit from ALND after SLNB for specific and overall survival , thus limiting ALND to a staging procedure .
CONCLUSIONS	A subgroup of patients with 3 MLN had a better SS with ALND , possibly due to an under-staging of the SLNB-alone group .

###24240600
OBJECTIVE	The aim of the current study was to determine the incorporation of cis ( c ) 9 , trans ( t ) 11-conjugated linoleic acid ( CLA ) and t10 , c12-CLA into porcine erythrocytes-both isomers were supplemented in equal proportions .
METHODS	The study group consisted of 16 piglets randomly assigned into experimental and control group .
METHODS	For the period of 5 weeks , the piglets from the experimental group were receiving a 1.2 % CLA supplement while the controls were supplemented with the same amount of sunflower oil .
METHODS	For the remaining 7 weeks , the piglets were fed without a supplement .
METHODS	Blood samples to evaluate incorporation of CLA into erythrocyte membranes were taken from all animals on weekly basis .
RESULTS	Compared to t10 , c12-CLA isomer , proportion of c9 , t11-CLA isomer in the membrane of erythrocytes was higher for the whole time of the study period .
RESULTS	After 4 weeks of feeding , it approaches the plateau .
RESULTS	The peak value for both isomers was measured at the end of week 5 , with a value of 3.24 g c9 , t11-CLA/100 g of fatty acids and a 1.09 g t10 , c12-CLA/100 g of fatty acids ( p < 0.0001 ) .
RESULTS	After cessation of supplementation , the proportion of both isomers gradually decreased to be almost completely washed out-in 7 weeks .
CONCLUSIONS	During supplementation with equivalent amounts of CLA isomers , their proportion in membranes of porcine erythrocytes increases with time , with higher proportion of c9 , t11-CLA .
CONCLUSIONS	CLA isomers probably differently incorporate into different cell membranes at different species which could explain its various biological functions .

###25359394
BACKGROUND	Currently , endovascular treatment is indicated to treat femoropopliteal lesions 15 cm .
BACKGROUND	However , the Achilles ' heel of femoropopliteal endovascular repair remains restenosis .
BACKGROUND	Paclitaxel eluting stents have shown promising results to prevent restenosis in femoropopliteal lesions compared to percutaneous transluminal angioplasty .
BACKGROUND	A recently released prospective registry using a newer generation of self-expandable nitinol stents ( Misago ; Terumo Corp. , Tokyo , Japan ) supports primary bare metal stenting as a first-line treatment for femoropopliteal lesions .
BACKGROUND	To date , no studies have been designed to compare bare metal stents to paclitaxel eluting stents for the treatment of femoropoliteal lesions .
BACKGROUND	The BATTLE trial was designed to compare paclitaxel eluting stents ( Zilver PTX ) and a last generation bare self-expandable nitinol stents ( Misago RX , Terumo Corp. , Tokyo , Japan ) in the treatment of intermediate length femoropopliteal lesions ( 14 cm ) .
METHODS	A prospective , randomized ( 1:1 ) , controlled , multicentric and international study has been designed .
METHODS	One hundred and eighty-six patients fulfilling the inclusion criteria will be randomized to one of the two assessments of endovascular repair to treat de novo femoropopliteal lesions 14 cm in symptomatic patients ( Rutherford 2 to 5 ) : bare stent group and paclitaxel eluting stent group .
METHODS	The primary endpoint is freedom from in-stent restenosis at 1 year defined by a peak systolic velocity index > 2.4 ( restenosis of > 50 % ) at the target lesion and assessed by duplex scan .
METHODS	Our main objective is to demonstrate the clinical superiority of primary stenting using Zilver PTX stent system versus bare metal self-expandable stenting in the treatment of femoropopliteal lesions in patients with symptomatic peripheral arterial disease .
CONCLUSIONS	This is the first randomized and controlled study to compare the efficacy of bare metal stents and paclitaxel eluting stents for the treatment of femoropopliteal lesions .
CONCLUSIONS	It may clarify the indication of stent choice for femoropopliteal lesions of intermediate length .
BACKGROUND	Clinicaltrials.gov identifier : NCT02004951 .3 December 2013 .

###24383962
BACKGROUND	This clinical trial evaluated the pharmacokinetics and safety/tolerability of amikacin/fosfomycin solution using a vibrating plate nebulizer , in mechanically ventilated patients with ventilator-associated tracheobronchitis ( VAT ) or ventilator-associated pneumonia ( VAP ) .
METHODS	Nine adult patients were consented to receive three escalating doses of a combination of 50mg/mL amikacin and 20mg/mL fosfomycin ; doses were separated by 242hr .
METHODS	On day 3 , patients received two blinded , randomized treatments ( amikacin/fosfomycin and volume-matched placebo ) , separated by 2hr .
METHODS	All treatments were administered with a single-patient , multitreatment nebulizer ( Investigational eFlow ( ) Inline Nebulizer System ; PARI Pharma GmbH , positioned in the inspiratory limb tubing between the ventilator and the patient .
METHODS	The nebulizer remained in-line until all treatments had been delivered .
METHODS	Concentrations of amikacin and fosfomycin were measured in tracheal aspirate and plasma samples obtained during the 24hr after each dose .
RESULTS	Fifteen minutes after dosing with the 300/120mg amikacin/fosfomycin combination , tracheal aspirate amikacin concentrationsSD were 12,3903,986 g/g , and fosfomycin concentrations were 6,1742,548 g/g ( n = 6 ) .
RESULTS	Airway clearance was rapid .
RESULTS	Plasma concentrations were subtherapeutic ; the highest observed amikacin plasma concentration was 1.4 g/mL , and the highest observed fosfomycin plasma concentration was 0.8 g/mL .
RESULTS	Administration time was approximately 2min/mL .
RESULTS	No adverse effects on respiratory rate , peak airway pressures , or oxygenation were observed during or following drug or placebo administration .
CONCLUSIONS	High tracheal aspirate concentrations of amikacin and fosfomycin were achieved in mechanically ventilated patients with VAT or VAP after aerosolized administration with an inline nebulizer system .
CONCLUSIONS	Airway clearance was rapid .
CONCLUSIONS	No adverse respiratory effects were noted during or following drug administration .

###24231135
OBJECTIVE	To investigate whether low-intensity ergometer aerobic training has beneficial effect on glucose tolerance in nondiabetic patients with severely impaired stroke .
METHODS	Fifty-four severely impaired stroke survivors were recruited and randomly assigned to the experimental group and control group .
METHODS	They have no diabetes history with fasting plasma glucose less than 7 mmol/L .
METHODS	Both groups participated in a 6-week rehabilitation training program with low-intensity ergometer aerobic training added only in the experimental group 3 times per week .
METHODS	Primary outcome variables were fasting glucose , fasting insulin , 2-hour glucose , and homeostasis model assessment-insulin resistance ( HOMA-IR ) in oral glucose tolerance test before and after intervention .
RESULTS	Before intervention , 36 of 54 ( 66.7 % ) were diagnosed with impaired glucose status or diabetic glucose tolerance totally .
RESULTS	The average 2-hour plasma glucose level was 9.14 1.39 mmol/L .
RESULTS	After intervention , aerobic training significantly improved fasting insulin ( from 8.51 2.01 U/mL to 7.11 2.02 U/mL ) , 2-hour glucose level ( from 9.13 1.14 mmol/L to 7.22 1.23 mmol/L ) , and HOMA-IR ( from 1.62 1.01 to 1.29 .79 ) in the intervention group compared with the control group ( P < .05 ) .
RESULTS	Aerobic training also significantly improved their glucose tolerance state ( P < .05 ) .
CONCLUSIONS	Preliminary findings suggest that abnormal glucose tolerance may be highly present among severely impaired nondiabetic stroke patients and low-intensity ergometer aerobic training may have beneficial role in improving glucose tolerance .

###24853923
METHODS	Randomized controlled trial with immediate follow-up .
OBJECTIVE	To evaluate the immediate effects of a low-amplitude , high-velocity thrust thoracic spine manipulation ( TSM ) on pain and scapular kinematics during elevation and lowering of the arm in individuals with shoulder impingement syndrome ( SIS ) .
OBJECTIVE	The secondary objective was to evaluate the immediate effects of TSM on scapular kinematics during elevation and lowering of the arm in individuals without symptoms .
BACKGROUND	Considering the regional interdependence among the shoulder and the thoracic and cervical spines , TSM may improve pain and function in individuals with SIS .
BACKGROUND	Comparing individuals with SIS to those without shoulder pathology may provide information on the effects of TSM specifically in those with SIS .
METHODS	Fifty subjects ( mean SD age , 31.8 10.9 years ) with SIS and 47 subjects ( age , 25.8 5.0 years ) asymptomatic for shoulder dysfunction were randomly assigned to 1 of 2 interventions : TSM or a sham intervention .
METHODS	Scapular kinematics were analyzed during elevation and lowering of the arm in the sagittal plane , and a numeric pain rating scale was used to assess shoulder pain during arm movement at preintervention and postintervention .
RESULTS	For those in the SIS group , shoulder pain was reduced immediately after TSM and the sham intervention ( mean SD preintervention , 2.9 2.5 ; postintervention , 2.3 2.5 ; P < .01 ; moderate effect size [ Cohen d = 0.2 ] ) .
RESULTS	Scapular internal rotation increased 0.5 0.02 ( P = .04 ; small effect size [ Cohen d < 0.1 ] ) during elevation of the arm after TSM and sham intervention in the SIS group only .
RESULTS	Subjects with and without SIS who received TSM and asymptomatic subjects who received the sham intervention had a significant increase ( 1.6 2.7 ) in scapular upward rotation postintervention ( P < .05 ; small effect size [ Cohen d < 0.2 ] ) , which was not considered clinically significant .
RESULTS	Scapular anterior tilt increased 1.0 4.8 during elevation and lowering of the arm postmanipulation ( P < .05 ; small effect size [ Cohen d < 0.2 ] ) in the asymptomatic subjects who received TSM .
CONCLUSIONS	Shoulder pain in individuals with SIS immediately decreased after a TSM .
CONCLUSIONS	The observed changes in scapular kinematics following TSM were not considered clinically important .
METHODS	Therapy , level 4 .
METHODS	J Orthop Sports Phys Ther 2014 ; 44 ( 7 ) :475 -487 .
METHODS	Epub 22 May 2014 .
METHODS	doi :10.2519 / jospt .2014.4760 .

###25310749
BACKGROUND	The considerably high risk of skin cancer development among transplant recipients warrants effective and efficient patient education on sun-protective behaviors .
OBJECTIVE	To evaluate the effectiveness and patient satisfaction of a brief educational video on skin cancer risks and sun-protective behaviors in the transplant population during a routine posttransplant follow-up visit , as compared with an educational handout .
METHODS	One hundred posttransplant patients were randomized to receive either video or pamphlet education about skin cancer .
METHODS	The primary outcome measure was knowledge acquisition , which was assessed using a 10-criterion grading instrument before and after the assigned educational intervention .
METHODS	The secondary outcome measure was patient satisfaction with the particular educational intervention received .
RESULTS	Comparison between the 2 treatment groups demonstrated that the video group had significantly greater improvement in knowledge scores ( 3.96 1.69 ) as compared with the pamphlet group ( 1.76 1.42 , p < .01 ) .
RESULTS	Moreover , subjects in the video group rated the educational material as more useful and appealing than did subjects in the pamphlet group .
CONCLUSIONS	These findings suggest an inherent appeal for audio-visual presentation and point its potential to improve patients ' knowledge of their increased risk of skin cancer and preventive skin cancer measures .

###25838311
BACKGROUND	Nitrite exhibits hypoxia-dependent vasodilator properties , selectively dilating capacitance vessels in healthy subjects .
BACKGROUND	Unlike organic nitrates , it seems not to be subject to the development of tolerance .
BACKGROUND	Currently , therapeutic options for decompensated heart failure ( HF ) are limited .
BACKGROUND	We hypothesized that by preferentially dilating systemic capacitance and pulmonary resistance vessels although only marginally dilating resistance vessels , sodium nitrite ( NaNO2 ) infusion would increase cardiac output but reduce systemic arterial blood pressure only modestly .
BACKGROUND	We therefore undertook a first-in-human HF proof of concept/safety study , evaluating the hemodynamic effects of short-term NaNO2 infusion .
RESULTS	Twenty-five patients with severe chronic HF were recruited .
RESULTS	Eight received short-term ( 5 minutes ) intravenous NaNO2 at 10 g/kg/min and 17 received 50 g/kg/min with measurement of cardiac hemodynamics .
RESULTS	During infusion of 50 g/kg/min , left ventricular stroke volume increased ( from 43.2221.5 to 51.8423.6 mL ; P = 0.003 ) , with marked falls in pulmonary vascular resistance ( by 29 % ; P = 0.03 ) and right atrial pressure ( by 40 % ; P = 0.007 ) , but with only modest falls in mean arterial blood pressure ( by 4 mm Hg ; P = 0.004 ) .
RESULTS	The increase in stroke volume correlated with the increase in estimated trans-septal gradient ( = pulmonary capillary wedge pressure-right atrial pressure ; r = 0.67 ; P = 0.003 ) , suggesting relief of diastolic ventricular interaction as a contributory mechanism .
RESULTS	Directionally similar effects were observed for the above hemodynamic parameters with 10 g/kg/min ; this was significant only for stroke volume , not for other parameters .
CONCLUSIONS	This first-in-human HF efficacy/safety study demonstrates an attractive profile during short-term systemic NaNO2 infusion that may be beneficial in decompensated HF and warrants further evaluation with longer infusion regimens .

###25730338
BACKGROUND	Individual assessment of the amplitude of a physiologic reflex evoked by a standardized noxious test ( SNT ) before surgical stimulation has been suggested to predict movement upon the forthcoming surgical stimulation .
BACKGROUND	This study aimed to compare the ability of pupillary dilatation reflex amplitude ( PDRA ) evoked by an SNT and estimated remifentanil effect-site concentration ( Ce ) to predict movement upon surgical stimulation .
METHODS	Eighty female patients were anesthetized for vacuum aspiration with propofol ( Ce 4 g/ml ) and remifentanil .
METHODS	Remifentanil Ce was randomized to 0 , 1 , 3 , or 5ng/ml .
METHODS	SNT was a 60-mA , 5-s , 100-Hz tetanus applied on median nerve before cervix dilatation .
METHODS	PDRA was calculated as the difference in pupillary diameter after and before SNT .
METHODS	Movement upon cervix dilatation was recorded by an independent observer .
METHODS	Ability of PDRA and estimated remifentanil Ce to discriminate movers from non-movers during cervix dilatation was measured as the area under the receiver operating characteristics curve .
RESULTS	Twenty-one of the 76 patients analyzed moved during cervix dilatation .
RESULTS	Mean PDRA ( 1 SD ) evoked by SNT was 2.01.2 mm in movers and 0.60.7 in non-movers ( P < 0.0001 ) .
RESULTS	Remifentanil Ce was 0.20.4 ng/ml in movers and 3.01.7 in non-movers ( P < 0.0001 ) .
RESULTS	Area under the receiver operating characteristics curve for PDRA was 0.90 ( 95 % CI , 0.83 to 0.96 ) and for remifentanil Ce 0.94 ( 0.89 to 0.98 ) , without any significant difference between the two areas .
CONCLUSIONS	PDRA evoked by an SNT is as accurate as the estimated remifentanil Ce to predict movement upon cervix dilatation .
CONCLUSIONS	PDRA could be valuable when estimated opioid Ce is not available or reliable .

###25038985
BACKGROUND	Tobacco smoking is the leading cause of preventable death in developed countries .
BACKGROUND	Our previous studies in animal models and humans suggest that repeated activation of cue-induced craving networks followed by electromagnetic stimulation of the dorsal prefrontal cortex ( PFC ) can cause lasting reductions in drug craving and consumption .
BACKGROUND	We hypothesized that disruption of these circuitries by deep transcranial magnetic stimulation ( TMS ) of the PFC and insula bilaterally can induce smoking cessation .
METHODS	Adults ( N = 115 ) who smoke at least 20 cigarettes/day and failed previous treatments were recruited from the general population .
METHODS	Participants were randomized to receive 13 daily sessions of high-frequency , low-frequency or sham stimulation following , or without , presentation of smoking cues .
METHODS	Deep TMS was administered using an H-coil version targeting the lateral PFC and insula bilaterally .
METHODS	Cigarette consumption was evaluated during the treatment by measuring cotinine levels in urine samples and recording participants ' self-reports as a primary outcome variable .
METHODS	Dependence and craving were assessed using standardized questionnaires .
RESULTS	High ( but not low ) frequency deep TMS treatment significantly reduced cigarette consumption and nicotine dependence .
RESULTS	The combination of this treatment with exposure to smoking cues enhanced reduction in cigarette consumption leading to an abstinence rate of 44 % at the end of the treatment and an estimated 33 % 6 months following the treatment .
CONCLUSIONS	This study further implicates the lateral PFC and insula in nicotine addiction and suggests the use of deep high-frequency TMS of these regions following presentation of smoking cues as a promising treatment strategy .

###25441329
BACKGROUND	The differential diagnosis between pre - and postcapillary pulmonary hypertension ( PH ) is of major therapeutic relevance and thus requires optimal clinical probability assessment with echocardiography .
METHODS	We prospectively analyzed 152 consecutive patients referred to a PH center over a 1-year period undergoing quasi-simultaneous ( within 1 hour ) echocardiography and right heart catheterization .
METHODS	Echocardiography was performed as usually recommended for the assessment of PH and left heart conditions .
METHODS	PH was defined as a mean pulmonary artery pressure 25 mm Hg .
METHODS	Postcapillary PH was diagnosed on the basis of a pulmonary capillary wedge pressure > 15 mm Hg .
RESULTS	Ten of 152 patients ( 7 % ) had no PH , 81 of 152 ( 53 % ) had precapillary PH , and 61 of 152 ( 40 % ) had postcapillary PH. The following five echocardiographic variables were found to predict precapillary PH : right heart chamber larger than the left ( P = .0018 ) , left ventricular eccentricity index > 1.2 ( P = .0039 ) , dilated inferior vena cava without inspiratory collapse ( P = .0076 ) , E/e ' ratio 10 ( P = .00001 ) , and the right ventricle forming the heart apex ( P = .0144 ) .
RESULTS	Beta coefficients from multiple logistic regression were significant for dilated inferior vena cava without inspiratory collapse ( P = .0464 ) and E/e ' ratio 10 ( P = .0002 ) .
RESULTS	The score based on coefficients , ranging from 3 to 34 points , resulted in optimal discrimination at > 5 , with a positive predictive value of 67.9 % and a negative predictive value of 77.5 % for precapillary PH.
CONCLUSIONS	Echocardiography enables a clinically satisfactory differential diagnosis between pre - and postcapillary PH.

###24824813
BACKGROUND	Multiple prospective studies have confirmed safety and efficacy of laparoscopic inguinal herniorraphy with single-port compared to multiport surgery .
BACKGROUND	This prospective randomized controlled trial aimed to assess safety , efficacy and potential benefits of single-port total extraperitoneal inguinal herniorraphy beyond the learning curve .
METHODS	All referred patients with inguinal/femoral hernias were enrolled from December 2011 to February 2013 .
METHODS	Exclusion criteria included workers compensation cases .
METHODS	Identical balloon dissector , light-weight mesh and non-absorbable tacks were used in all cases .
METHODS	For single-port cases Triport was used while structural balloon trocar/inflation bulb for multiport cases .
METHODS	Results were analyzed with IBM ( ) SPSS ( ) version 22 for Windows .
RESULTS	Participation rate was 100 % with 157 inguinal/femoral hernias in 100 patients : 51 randomized to single-port and 49 to multiport group .
RESULTS	There was no conversion to open surgery/need for additional ports .
RESULTS	There were no statistical differences between single-port and multiport groups with respect to age , sex , body mass index , American Society of Anesthesiologists scores , preoperative pain , hernia defect sizes and length of hospital stay .
RESULTS	Operation times were equivalent for single-port and multiport 60.0 vs 61.0 min , P = 0.23 , respectively .
RESULTS	Significantly , single-port patients ingested fewer pain killers : 6 tablets vs 14 Dextropropoxyphene tablets , P < 0.001 , experienced less pain ( visual analog scores ) on day 1 and 7 post-op op : 2.5 and 0 , P < 0.001 compared to 4.5 and 2.5 , P < 0.001 , respectively , returned to work/normal physical activities 7days quicker : 7.0 vs 14.0 , P < 0.001 and had higher cosmetic scar scores at 6-week follow-up : 24 vs 21 , P < 0.001 , compared to multiport patients .
RESULTS	There were no mortalities , morbidities or recurrences after follow-up of 6-21months .
CONCLUSIONS	Compared to multiport , single-port laparoscopic total extraperitoneal inguinal herniorraphy , when performed by a high-volume and highly dedicated hernia surgeon , resulted in significantly reduced postoperative pain , analgesic requirements , quicker return to work/normal activities , improved cosmesis , and equivalent safety and efficacy .

###25199059
BACKGROUND	Some patients with severe asthma have frequent exacerbations associated with persistent eosinophilic inflammation despite continuous treatment with high-dose inhaled glucocorticoids with or without oral glucocorticoids .
METHODS	In this randomized , double-blind , double-dummy study , we assigned 576 patients with recurrent asthma exacerbations and evidence of eosinophilic inflammation despite high doses of inhaled glucocorticoids to one of three study groups .
METHODS	Patients were assigned to receive mepolizumab , a humanized monoclonal antibody against interleukin-5 , which was administered as either a 75-mg intravenous dose or a 100-mg subcutaneous dose , or placebo every 4 weeks for 32 weeks .
METHODS	The primary outcome was the rate of exacerbations .
METHODS	Other outcomes included the forced expiratory volume in 1 second ( FEV1 ) and scores on the St. George 's Respiratory Questionnaire ( SGRQ ) and the 5-item Asthma Control Questionnaire ( ACQ-5 ) .
METHODS	Safety was also assessed .
RESULTS	The rate of exacerbations was reduced by 47 % ( 95 % confidence interval [ CI ] , 29 to 61 ) among patients receiving intravenous mepolizumab and by 53 % ( 95 % CI , 37 to 65 ) among those receiving subcutaneous mepolizumab , as compared with those receiving placebo ( P < 0.001 for both comparisons ) .
RESULTS	Exacerbations necessitating an emergency department visit or hospitalization were reduced by 32 % in the group receiving intravenous mepolizumab and by 61 % in the group receiving subcutaneous mepolizumab .
RESULTS	At week 32 , the mean increase from baseline in FEV1 was 100 ml greater in patients receiving intravenous mepolizumab than in those receiving placebo ( P = 0.02 ) and 98 ml greater in patients receiving subcutaneous mepolizumab than in those receiving placebo ( P = 0.03 ) .
RESULTS	The improvement from baseline in the SGRQ score was 6.4 points and 7.0 points greater in the intravenous and subcutaneous mepolizumab groups , respectively , than in the placebo group ( minimal clinically important change , 4 points ) , and the improvement in the ACQ-5 score was 0.42 points and 0.44 points greater in the two mepolizumab groups , respectively , than in the placebo group ( minimal clinically important change , 0.5 points ) ( P < 0.001 for all comparisons ) .
RESULTS	The safety profile of mepolizumab was similar to that of placebo .
CONCLUSIONS	Mepolizumab administered either intravenously or subcutaneously significantly reduced asthma exacerbations and was associated with improvements in markers of asthma control .
CONCLUSIONS	( Funded by GlaxoSmithKline ; MENSA ClinicalTrials.gov number , NCT01691521 . )

###26121892
BACKGROUND	Although oral ketamine has been used in some cases to reduce pain in children , the use of this drug to reduce pain after tonsillectomy has not been studied yet .
METHODS	This double-blind clinical trial was conducted in 2009 in 92 children who were aged three to nine years old , met ASA I or II criteria , and were candidate for tonsillectomy .
METHODS	Patients were divided randomly into two groups .
METHODS	Half an hour before general anesthesia , 5 mg/kg ketamine mixed in 2 cc/kg apple juice was given to the children in oral ketamine group and 2 cc/kg of apple juice alone was given to the children in the peritonsillar group .
METHODS	After general anesthesia and three minutes before surgery 1 cc of 0.9 % normal saline in the oral group and 1cc of ketamine ( 0.5 mg/kg ) in the peritonsillar group was injected to the tonsil bed of patients .
RESULTS	There was no difference between the two groups in terms of sex , age , and weight .
RESULTS	Duration of surgery was significantly shorter in the peritonsillar group ( P < 0.001 ) and the severity of postoperative bleeding was significantly higher in peritonsillar group ( P = 0.022 ) .
RESULTS	However , postoperative bleeding recurred in 25 patients ( 27 % ) and there was no statistically significant difference between the two groups .
RESULTS	The level of pain in children six hours after surgery according to CHEOPS criteria was significantly lower in the peritonsillar group ( 0.9 0.8 ) than in the oral group ( 2.6 1 ) ( P < 0.001 ) .
CONCLUSIONS	The finding of this study showed that , compared with the peritonsillar infiltration of ketamine , the use of oral ketamine before general anesthesia was less effective in reducing postoperative pain of tonsillectomy in children .

###25042773
BACKGROUND	Websites and phone apps are increasingly used to track weights during weight loss interventions , yet the longitudinal accuracy of these self-reported weights is uncertain .
OBJECTIVE	Our goal was to compare the longitudinal accuracy of self-reported weights entered online during the course of a randomized weight loss trial to measurements taken in the clinic .
OBJECTIVE	We aimed to determine if accuracy of self-reported weight is associated with weight loss and to determine the extent of misclassification in achieving 5 % weight loss when using self-reported compared to clinic weights .
METHODS	This study examined the accuracy of self-reported weights recorded online among intervention participants in the Hopkins Practice-Based Opportunities for Weight Reduction ( POWER ) trial , a randomized trial examining the effectiveness of two lifestyle-based weight loss interventions compared to a control group among obese adult patients with at least one cardiovascular risk factor .
METHODS	One treatment group was offered telephonic coaching and the other group was offered in-person individual coaching and group sessions .
METHODS	All intervention participants ( n = 277 ) received a digital scale and were asked to track their weight weekly on a study website .
METHODS	Research staff used a standard protocol to measure weight in the clinic .
METHODS	Differences ( self-reported weight - clinic weight ) indicate if self-report under ( - ) or over ( + ) estimated clinic weight using the self-reported weight that was closest in time to the clinic weight and was within a window ranging from the day of the clinic visit to 7 days before the 6-month ( n = 225 ) and 24-month ( n = 191 ) clinic visits .
METHODS	The absolute value of the differences ( absolute difference ) describes the overall accuracy .
RESULTS	Underestimation of self-reported weights increased significantly from 6 months ( mean -0.5 kg , SD 1.0 kg ) to 24 months ( mean -1.1 kg , SD 2.0 kg ; P = .002 ) .
RESULTS	The average absolute difference also increased from 6 months ( mean 0.7 kg , SD 0.8 kg ) to 24 months ( mean 1.3 , SD 1.8 kg ; P < .001 ) .
RESULTS	Participants who achieved the study weight loss goal at 24 months ( based on clinic weights ) had lower absolute differences ( P = .01 ) compared to those who did not meet this goal .
RESULTS	At 24 months , there was 9 % misclassification of weight loss goal success when using self-reported weight compared to clinic weight as an outcome .
RESULTS	At 24 months , those with self-reported weights ( n = 191 ) had three times the weight loss compared to those ( n = 73 ) without self-reported weights ( P < .001 ) .
CONCLUSIONS	Underestimation of weight increased over time and was associated with less weight loss .
CONCLUSIONS	In addition to intervention adherence , weight loss programs should emphasize accuracy in self-reporting .
BACKGROUND	ClinicalTrials.gov : NCT00783315 ; http://clinicaltrials.gov/show/NCT00783315 ( Archived by WebCite at http://www.webcitation.org/6R4gDAK5K ) .

###25084776
OBJECTIVE	The quality of surgery with D3 resection in randomized controlled clinical trial [ Japan Clinical Oncology Group study ( JCOG0404 ) ] was assessed by evaluation of the photo documentation of both open and laparoscopic surgeries .
METHODS	A multi-institutional randomized-controlled trial ( JCOG0404 ) was conducted to evaluate open and laparoscopic D3 resection ( complete mesocolic excision + ligation and dissection at the root of the main vessels ) for Stage II/III colon cancer ( UMIN-CTR number C000000105 ) .
METHODS	A total of 1057 ( open , 528 ; laparoscopic , 529 ) eligible patients were enrolled .
METHODS	For quality control , it was ensured that the surgeries were performed by accredited surgeons , and a central committee reviewed each surgery on the basis of the submitted photographs of the resected field , specimen and skin incision .
RESULTS	For right-sided tumors , the rate of D3 resection was 98.5 % ( 131/133 ) in the open arm and 100 % ( 136/136 ) in the laparoscopic arm , and for left-sided tumors , they were 97.9 % ( 322/329 ) and 98.2 % ( 320/326 ) , respectively .
RESULTS	Sufficient length of the resected longitudinal margin was ensured in all cases .
RESULTS	The skin incisions made in all the cases were < 8 cm as defined in the protocol in laparoscopic arm .
CONCLUSIONS	Completion of high quality surgery with D3 resection was confirmed in JCOG0404 by central peer review of photographs of the surgical procedures in addition to operator regulations .
CONCLUSIONS	This study suggests that the central review of the photo documentation is one of the important tools to assure a quality control of surgical technique in the Phase III randomized-controlled study .

###25182805
BACKGROUND	Diffusion tensor imaging ( DTI ) is a magnetic resonance imaging ( MRI ) technique enabling visualization and measurement of white matter tracts .
BACKGROUND	Attention deficit hyperactivity disorder ( ADHD ) has been studied with DTI earlier with variable results , yet there is little research on remitted ADHD .
OBJECTIVE	To compare the brain white matter between ADHD drug nave subjects whose ADHD symptoms have mostly subsided and healthy controls .
METHODS	Tract-based spatial statistics ( TBSS ) was used to compare 30 subjects with adolescent ADHD with control subjects at the age of 22-23 years .
METHODS	The study population was derived from a population-based Northern Finland Birth Cohort 1986 .
METHODS	Fractional anisotropy ( FA ) , mean diffusivity ( MD ) , and measures of diffusion direction ( 1-3 ) were calculated .
METHODS	Permutation testing was used to test for differences in mean values of FA , MD , and 1-3 between the groups .
METHODS	The results were corrected for multiple comparisons across the whole white matter skeleton .
RESULTS	The ADHD group showed increased FA related to decreased radial diffusivity in the left forceps minor ( P < 0.05 ) .
RESULTS	In the vicinity along the same tract , axial diffusion was significantly decreased without any significant effect on FA .
RESULTS	No between-group difference in MD was observed .
RESULTS	Regressor analysis revealed no gender - , IQ - or GAF-related changes .
RESULTS	After removal of left handed subjects the statistical significance was only barely lost .
CONCLUSIONS	In a setting with remitted ADHD , the results may represent a compensatory mechanism in the left forceps minor .

###25523287
OBJECTIVE	MK-0888 is an investigational VEGFR-2 inhibitor with demonstrated potent in vitro enzyme activity .
OBJECTIVE	Clinical investigation in healthy volunteers and cancer patients was undertaken to evaluate its pharmacokinetic properties and early safety profile .
OBJECTIVE	Early data were used to guide whether further clinical development was warranted .
METHODS	Five phase I studies were conducted .
METHODS	Studies 1-4 were conducted in healthy male volunteers and examined safety and pharmacokinetics across a dose range of 0.5-100 mg .
METHODS	Single-dose and limited multiple-dose escalations were performed .
METHODS	Three formulations and food effect were assessed .
METHODS	Study 5 was a dose escalation study in cancer patients , evaluating pharmacokinetics and safety at doses of 6-100 mg administered up to twice daily .
RESULTS	Safety : MK-0888 was generally well tolerated in healthy volunteers at single doses up to 100 mg and in cancer patients at doses up to 100 mg twice daily .
RESULTS	Pharmacokinetics : After single-dose administration , MK-0888 was readily absorbed with a T ( max ) of 4-5 h and a half-life of 11.3-22 .7 h. AUC , C ( max ) , and C ( 24h ) increased in a slightly less than dose proportional manner .
RESULTS	With longer duration multiple-dose administration ( 2 weeks ) , trough concentrations decreased from Day 2 at doses of 50 mg twice daily and higher , suggestive of autoinduction of metabolism .
RESULTS	The efficacious trough pharmacokinetic target was not attained at steady state .
CONCLUSIONS	The pharmacokinetic behavior of MK-0888 does not support continued development .
CONCLUSIONS	The early pharmacokinetic profile of the compound provides important information as to the probability of success of MK-0888 achieving efficacious exposures .

###24594851
BACKGROUND	Osteoarthritis is the most frequent joint disease and is a leading cause of pain and locomotor disability in elderly people .
BACKGROUND	The treatment of osteoarthritis includes non-pharmacological , pharmacological , and surgical therapies .
BACKGROUND	Silver level evidence has been found concerning balneotherapy in osteoarthritis .
OBJECTIVE	The aim of this study was to evaluate how Lake Hvz thermal mineral water therapy influences pain , knee function , and quality of life in patients with knee osteoarthritis , compared to the control group .
METHODS	randomized , controlled , single-blind , follow-up study .
METHODS	Spa Hvz and St. Andrew Hospital for Rheumatic Diseases
METHODS	This study included 77 outpatients between 45 and 75 years of age with mild to moderate osteoarthritis of the knee meeting the American College of Rheumatology classification criteria .
METHODS	Patients were randomized into two groups .
METHODS	In group I ( n = 38 ) , subjects bathed in Lake Hvz and in group II ( N. = 39 ) , patients were treated in a pool full of tap water .
METHODS	Water temperature was 34 C for both groups .
METHODS	Participants underwent 30-minute therapy sessions , five times a week for three weeks .
METHODS	Outcome measures were pain visual analogue scale scores , active flexion degree , knee circumference , stair-climb time , Western Ontario and McMaster Universities osteoarthritis index ( WOMAC ) , and EuroQoL Group 5-Dimension Self-Report Questionnaire score ( EQ-5D ) .
METHODS	Study parameters were recorded at baseline , immediately after treatment , and after 15 weeks .
RESULTS	Comparison of the two groups revealed a statistically significant difference in pain visual analogue scale scores ( P < 0.01 ) , active flexion degree ( P < 0.01 ) , physical function components of WOMAC ( P < 0.05 ) , and EQ-5D scores ( P < 0.05 ) even after 15 weeks .
CONCLUSIONS	Balneotherapy improved pain , function as well as the quality of life in patients with knee osteoarthritis .
CONCLUSIONS	Balneotherapy is a potentially useful treatment modality for patients with knee osteoarthritis .

###24703047
BACKGROUND	As new members of a drug class are developed , head-to-head trials are an important strategy to guide personalised treatment decisions .
BACKGROUND	We assessed two glucagon-like peptide-1 receptor agonists , once-weekly albiglutide and once-daily liraglutide , in patients with type 2 diabetes inadequately controlled on oral antidiabetic drugs .
METHODS	We undertook this 32-week , open-label , phase 3 non-inferiority study at 162 sites in eight countries : USA ( 121 sites ) , Australia ( 9 sites ) , Peru ( 7 sites ) , Philippines ( 7 sites ) , South Korea ( 5 sites ) , UK ( 5 sites ) , Israel ( 4 sites ) , and Spain ( 4 sites ) .
METHODS	841 adult participants ( aged 18 years ) with inadequately controlled type 2 diabetes and a BMI between 20 and 45 kg/m ( 2 ) were enrolled and randomised in a 1:1 ratio to receive albiglutide 30 mg once weekly titrated to 50 mg at week 6 , or liraglutide 06 mg once daily titrated to 12 mg at week 1 and 18 mg at week 2 .
METHODS	The randomisation schedule was generated by an independent randomisation team by the permuted block method with a fixed block size of 16 .
METHODS	Participants and investigators were unmasked to treatment .
METHODS	The primary endpoint was change from baseline in HbA1c for albiglutide versus liraglutide , with a 95 % CI non-inferiority upper margin of 03 % .
METHODS	The primary analysis was by modified intention to treat .
METHODS	The study is registered with ClinicalTrials.gov , number NCT01128894 .
RESULTS	422 patients were randomly allocated to the albigultide group and 419 to the liraglutide group ; 404 patients in the abliglutide group and 408 in the liraglutide group received the study drugs .
RESULTS	The primary endpoint analysis was done on the modified intention-to-treat population , which included 402 participants in the albiglutide group and 403 in the liraglutide group .
RESULTS	Model-adjusted change in HbA1c from baseline to week 32 was -078 % ( 95 % CI -087 to -069 ) in the albigludite group and -099 % ( -108 to -090 ) in the liraglutide group ; treatment difference was 021 % ( 008-034 ; non-inferiority p value = 00846 ) .
RESULTS	Injection-site reactions occurred in more patients given albiglutide than in those given liraglutide ( 129 % vs 54 % ; treatment difference 75 % [ 95 % CI 36-114 ] ; p = 00002 ) , whereas the opposite was the case for gastrointestinal events , which occurred in 490 % of patients in the liraglutide group versus 359 % in the albiglutide group ( treatment difference -131 % [ 95 % CI -199 to -64 ] ; p = 000013 ) .
CONCLUSIONS	Patients who received once-daily liraglutide had greater reductions in HbA1c than did those who received once-weekly albiglutide .
CONCLUSIONS	Participants in the albiglutide group had more injection-site reactions and fewer gastrointestinal events than did those in the liraglutide group .
BACKGROUND	GlaxoSmithKline .

###25886805
BACKGROUND	Up to 20 % of women experience postpartum depression ( PPD ) .
BACKGROUND	PPD is associated with anxiety and poor health-related quality of life ( HRQOL ) .
BACKGROUND	Efficacious treatments are critical ; many women with PPD prefer complementary therapies .
BACKGROUND	Thus , the current study examined yoga as a complementary therapy for PPD .
METHODS	Fifty-seven postpartum women with scores 12 on the Hamilton Depression Rating Scale were randomly assigned to a yoga ( N = 28 ) or wait-list control ( N = 29 ) group .
METHODS	The yoga intervention consisted of 16 classes over 8 weeks .
METHODS	Outcomes were depression , anxiety , and HRQOL .
RESULTS	The yoga group experienced significantly greater rate of improvement in depression , anxiety , and HRQOL , relative to the control group with moderate to large effects .
RESULTS	Reliable Change Index analyses revealed that 78 % of women in the yoga group experienced clinically significant change .
CONCLUSIONS	These findings support yoga as a promising complementary therapy for PPD , and warrant large-scale replication studies .
BACKGROUND	http://clinicaltrials.gov/NCT02213601 .

###25915102
BACKGROUND	The incidence of obesity hypoventilation syndrome ( OHS ) may be increasing in parallel with the present obesity epidemic .
BACKGROUND	Despite extensive noninvasive ventilation ( NIV ) and continuous positive airway pressure ( CPAP ) use in patients with OHS , information regarding efficacy is limited .
OBJECTIVE	We performed a large , multicenter randomized controlled study to determine the comparative efficacy of NIV , CPAP , and lifestyle modification ( control group ) using daytime PaCO2 as the main outcome measure .
METHODS	Sequentially screened patients with OHS with severe sleep apnea were randomized into the above-mentioned groups for a 2-month follow up .
METHODS	Arterial blood gas parameters , clinical symptoms , health-related quality-of-life assessments , polysomnography , spirometry , 6-minute-walk distance , dropouts , compliance , and side effects were evaluated .
METHODS	Statistical analysis was performed using intention-to-treat analysis , although adjustments for CPAP and NIV compliance were also analyzed .
RESULTS	In total , 351 patients were selected , and 221 were randomized .
RESULTS	NIV yielded the greatest improvement in PaCO2 and bicarbonate , with significant differences relative to the control group but not relative to the CPAP group .
RESULTS	In the CPAP group , PaCO2 improvement was significantly different than in the control group only after CPAP compliance adjustment .
RESULTS	Additionally , clinical symptoms and polysomnographic parameters improved similarly with NIV and CPAP relative to the control .
RESULTS	However , some health-related quality-of-life assessments , the spirometry , and 6-minute-walk distance results improved more with NIV than with CPAP .
RESULTS	Dropouts were similar between groups , and compliance and secondary effects were similar between NIV and CPAP .
CONCLUSIONS	NIV and CPAP were more effective than lifestyle modification in improving clinical symptoms and polysomnographic parameters , although NIV yielded better respiratory functional improvements than did CPAP .
CONCLUSIONS	Long-term studies must demonstrate whether this functional improvement has relevant implications .
CONCLUSIONS	Clinical trial registered with www.clinicaltrials.gov ( NCT01405976 ) .

###25311217
OBJECTIVE	Cure rates for localized high-risk prostate cancers ( PCa ) and some intermediate-risk PCa are frequently suboptimal with local therapy .
OBJECTIVE	Outcomes are improved by concomitant androgen-deprivation therapy ( ADT ) with radiation therapy , but not by concomitant ADT with surgery .
OBJECTIVE	Luteinizing hormone-releasing hormone agonist ( LHRHa ; leuprolide acetate ) does not reduce serum androgens as effectively as abiraterone acetate ( AA ) , a prodrug of abiraterone , a CYP17 inhibitor that lowers serum testosterone ( < 1 ng/dL ) and improves survival in metastatic PCa .
OBJECTIVE	The possibility that greater androgen suppression in patients with localized high-risk PCa will result in improved clinical outcomes makes paramount the reassessment of neoadjuvant ADT with more robust androgen suppression .
METHODS	A neoadjuvant randomized phase II trial of LHRHa with AA was conducted in patients with localized high-risk PCa ( N = 58 ) .
METHODS	For the first 12 weeks , patients were randomly assigned to LHRHa versus LHRHa plus AA .
METHODS	After a research prostate biopsy , all patients received 12 additional weeks of LHRHa plus AA followed by prostatectomy .
RESULTS	The levels of intraprostatic androgens from 12-week prostate biopsies , including the primary end point ( dihydrotestosterone/testosterone ) , were significantly lower ( dehydroepiandrosterone , ( 4 ) - androstene-3 ,17 - dione , dihydrotestosterone , all P < .001 ; testosterone , P < .05 ) with LHRHa plus AA compared with LHRHa alone .
RESULTS	Prostatectomy pathologic staging demonstrated a low incidence of complete responses and minimal residual disease , with residual T3 - or lymph node-positive disease in the majority .
CONCLUSIONS	LHRHa plus AA treatment suppresses tissue androgens more effectively than LHRHa alone .
CONCLUSIONS	Intensive intratumoral androgen suppression with LHRHa plus AA before prostatectomy for localized high-risk PCa may reduce tumor burden .

###25041495
BACKGROUND	We evaluated the analgesic effect of ropivacaine infiltration into the surgical wound after caesarean section .
METHODS	In a double-blind trial , 67 patients who were scheduled for caesarean section under spinal anaesthesia were randomly assigned to receive either 0.75 % ropivacaine or placebo ( NaCl 0.9 % ) through a multi-orifice catheter that was placed into the surgical wound , between the muscle fascia and the subcutaneous tissue .
METHODS	The study drug was administered as a bolus of 10ml at the end of the operation , followed by an infusion at 2ml/h for 48h .
METHODS	All patients were also given paracetamol and ibuprofen .
METHODS	The primary outcome was the total amount of rescue oxycodone needed during the first 48h post-operatively .
METHODS	Secondary outcomes included pain and patient satisfaction scores .
METHODS	Analyses were according to intention to treat .
RESULTS	The mean ( standard deviation ) amount of oxycodone administered during the first 48h was 47.520.9 mg in the ropivacaine group and 57.829.4 mg in the placebo group ( 95 % confidence interval for the difference between means , -22.8 -2.2 mg ; P = 0.10 ) .
RESULTS	There were no differences between the groups in pain scores or in patient satisfaction scores .
CONCLUSIONS	Continuous wound infiltration with ropivacaine did not decrease the need for opioids and had no impact on pain scores or patient satisfaction after caesarean section .

###25263601
BACKGROUND	Botulinum toxin type A is a first-line treatment for post-stroke focal spasticity , and the accuracy in delivering the toxin to the target muscles may influence the treatment outcome .
BACKGROUND	Our aim was to compare the reduction of spasticity and the related finger position at rest improvement in post-stroke patients treated with botulinum toxin type A in upper limb muscles using ultrasound guidance and manual needle placement .
METHODS	In a randomized clinical trial , two groups of 15 stroke patients were treated with botulinum toxin type A injections in the wrist and finger flexor muscles of the affected upper limb using ultrasound guidance or manual needle placement .
METHODS	The Modified Ashworth Scale and the finger position at rest were measured at baseline and one month after toxin injections .
RESULTS	After one month of follow-up from toxin injections , the Modified Ashworth Scale and finger position at rest significantly improved in both treatment groups , although these clinical outcomes were significantly better in patients treated under ultrasound guidance than in patients injected using manual needle placement .
CONCLUSIONS	Ultrasound guidance for botulinum toxin type A injections could improve clinical outcome measures better than manual needle placement in post-stroke patients with spasticity .

###24980226
BACKGROUND	This study was designed to investigate the topical anesthetic efficacy of four different solutions including lidocaine spray , bupivacaine , ropivacaine , and prilocaine used in patients undergoing transnasal fiberoptic nasopharyngolaryngoscopic examination ( TFL ) .
METHODS	The study included 200 patients who underwent anterior rhinoscopy and TFL examination as a part of routine otolaryngological evaluation in our outpatient clinics .
METHODS	Of these , 111 were female and 89 were male patients .
METHODS	The mean age of the patients was 32 8 years ( aged between 19 and 55 years ) .
METHODS	The patients were randomly divided into five groups .
METHODS	Five groups received one of the local anesthetics studied in our trial ( 10 % lidocaine , 0.5 % ropivacaine , 0.25 % bupivacaine , 2 % prilocaine , and saline solution ) in each right side of the nose for 10 minutes before TFL .
METHODS	Each separate examination was performed on the right side of the nasal cavity .
METHODS	After the examination , the patients were asked to note the intensity of the pain that they have experienced during the TFL , by using a 100-mm visual analog scale ( VAS ) .
RESULTS	The mean VAS scores were 2.08 ( SD , 0.62 ) in the lidocaine group , 2.21 ( SD , 0.66 ) in the prilocaine group , 3.92 ( SD , 0.58 ) in the ropivacaine group , 4.15 ( SD , 0.64 ) in the bupivacaine group , and 6.35 ( SD , 0.65 ) in the saline solution group .
RESULTS	The lidocaine and prilocaine groups had significantly better VAS scores versus ropivacaine , bupivacaine , and saline solution groups ( p < 0.05 ) .
CONCLUSIONS	To provide ideal examination comfort and optimum patient tolerability during TFL evaluation of upper respiratory airway topical lidocaine and prilocaine applications were found to be more efficacious and effective medication for anesthesia of the intranasal mucosa compared with bupivacaine and ropivacaine solutions .

###25552403
OBJECTIVE	N ( 1 ) - methylnicotinamide ( NMN ) was proposed as an in vivo probe for drug interactions involving renal cation transporters , which , for example , transport the oral antidiabetic drug metformin , based on a study with the inhibitor pyrimethamine .
OBJECTIVE	The role of NMN for predicting other interactions with involvement of renal cation transporters ( organic cation transporter 2 , OCT2 ; multidrug and toxin extrusion proteins 1 and 2-K , MATE1 and MATE2-K ) is unclear .
METHODS	We determined inhibition of metformin or NMN transport by trimethoprim using cell lines expressing OCT2 , MATE1 , or MATE2-K .
METHODS	Moreover , a randomized , open-label , two-phase crossover study was performed in 12 healthy volunteers .
METHODS	In each phase , 850 mg metformin hydrochloride was administered p.o. in the evening of day 4 and in the morning of day 5 .
METHODS	In phase B , 200 mg trimethoprim was administered additionally p.o. twice daily for 5 days .
METHODS	Metformin pharmacokinetics and effects ( measured by OGTT ) and NMN pharmacokinetics were determined .
RESULTS	Trimethoprim inhibited metformin transport with K i values of 27.2 , 6.3 , and 28.9 M and NMN transport with IC50 values of 133.9 , 29.1 , and 0.61 M for OCT2 , MATE1 , and MATE2-K , respectively .
RESULTS	In the clinical study , trimethoprim increased metformin area under the plasma concentration-time curve ( AUC ) by 29.5 % and decreased metformin and NMN renal clearances by 26.4 and 19.9 % , respectively ( p 0.01 ) .
RESULTS	Moreover , decreases of NMN and metformin renal clearances due to trimethoprim correlated significantly ( r S = 0.727 , p = 0.010 ) .
CONCLUSIONS	These data on the metformin-trimethoprim interaction support the potential utility of N ( 1 ) - methylnicotinamide as an endogenous probe for renal drug-drug interactions with involvement of renal cation transporters .

###24803100
OBJECTIVE	Variability in responsiveness to clopidogrel is a clinical problem in secondary prevention after cerebral ischaemia which has been suggested to be linked to competitive metabolization of clopidogrel and cytochrome P450 ( CYP ) 3A4-oxidated statins such as simvastatin .
OBJECTIVE	We assessed the hypothesis that simvastatin , in contrast to CYP 2C9-metabolized fluvastatin , reduces clopidogrel-mediated platelet inhibition .
METHODS	We performed a randomized , double-blind , double-dummy , two period crossover study in 13 patients with cerebral ischaemia ( 8F , 5M ) , aged 64.18.0 years ( meanSD ) .
METHODS	After a 14 day period in which all patients received 75mg clopidogrelday ( -1 ) , patients additionally received either 20mg simvastatinday ( -1 ) or 80mg fluvastatinday ( -1 ) for 14 days .
METHODS	Regimens were crossed over after a 14 day wash-out period and switched regimens were continued for another 14 days .
METHODS	Platelet aggregation , clopidogrel active metabolite ( CAM ) plasma concentrations and routine laboratory parameters including prothrombin time ( PT ) Quick percent value were assessed at baseline and following each treatment phase .
RESULTS	Clopidogrel reduced platelet aggregation in all patients as expected .
RESULTS	Platelet aggregation and CAM plasma concentrations were unaltered when simvastatin or fluvastatin was added to clopidogrel .
RESULTS	Simvastatin decreased PT Quick percent value ( decrease from 10910.5 % to 10311 % , P < 0.05 ) when combined with clopidogrel but there was no such change following treatment with fluvastatin and clopidogrel .
CONCLUSIONS	Our data indicate that treatment with CYP 3A4-metabolized simvastatin does not jeopardize clopidogrel-mediated inhibition of platelet aggregation .
CONCLUSIONS	After co-administration of simvastatin and clopidogrel we observed a decrease in the PT Quick percent value which could be due to simvastatin-induced reduction of activity of prothrombin fragment 1 + 2 .

###24852946
OBJECTIVE	The aim of this study was to test the efficacy of long-term , daily intake of erythritol and xylitol candy , compared with sorbitol candy , on the development of enamel and dentin caries lesions .
METHODS	The study was a double-blind randomized controlled prospective clinical trial .
METHODS	Altogether 485 primary school children , first - and second-graders at baseline , from southeastern Estonia participated in this 3-year intervention .
METHODS	Each child consumed four erythritol , xylitol or sorbitol ( control ) candies three times per school day .
METHODS	The daily intake of polyol was about 7.5 g.
METHODS	The International Caries Detection and Assessment System ( ICDAS ) was used in the clinical examinations by four calibrated examiners at baseline and at 12 , 24 and 36 months .
RESULTS	The annual examination analyses and the follow-up analyses confirmed that the number of dentin caries teeth and surfaces at 24 months follow-up and surfaces at 36 months follow-up was significantly lower in the mixed dentition in the erythritol group than in the xylitol or control group .
RESULTS	Time of enamel/dentin caries lesions to develop and of dentin caries lesions to progress was significantly longer in the erythritol group compared to the sorbitol and xylitol groups .
RESULTS	Also the increase in caries score was lower in the erythritol group than in the other groups .
CONCLUSIONS	In the follow-up examinations , a lower number of dentin caries teeth and surfaces was found in the erythritol group than in the xylitol or control groups .
CONCLUSIONS	Time to the development of caries lesions was longest in the erythritol group .
BACKGROUND	ClinicalTrials.gov Identifier NCT01062633 .

###25089344
OBJECTIVE	Patients ' recall of provided information during bad news consultations is poor .
OBJECTIVE	According to the attentional narrowing hypothesis , the emotional arousal caused by the bad news might be responsible for this hampered information processing .
OBJECTIVE	Because affective communication has proven to be effective in tempering patients ' emotional reactions , the current study used an experimental design to explore whether physician 's affective communication in bad news consultations decreases patients ' anxiety and uncertainty and improves information recall .
METHODS	Two scripted video-vignettes of a bad news consultation were used in which the physician 's verbal communication was manipulated ( standard vs. affective condition ) .
METHODS	Fifty healthy women ( i.e. , analogue patients ) randomly watched 1 of the 2 videos .
METHODS	The effect of communication on participants ' anxiety , uncertainty , and recall was assessed by self-report questionnaires .
METHODS	Additionally , a moderator analysis was performed .
RESULTS	Affective communication reduced anxiety ( p = .01 ) and uncertainty ( p = .04 ) , and improved recall ( p = .05 ) , especially for information about prognosis ( p = .04 ) and , to some extent , for treatment options ( p = .07 ) .
RESULTS	The moderating effect of ( reduced ) anxiety and uncertainty on recall could not be confirmed and showed a trend for uncertainty .
CONCLUSIONS	Physicians ' affective communication can temper patients ' anxiety and uncertainty during bad news consultations , and enhance their ability to recall medical information .
CONCLUSIONS	The reduction of anxiety and uncertainty could not explain patients ' enhanced recall , which leaves the underlying mechanism unspecified .
CONCLUSIONS	Our findings underline the importance of addressing patients ' emotions and provide empirical support to incorporate this in clinical guidelines and recommendations .

###25539637
BACKGROUND	Trials aimed at preventing cognitive decline through cognitive stimulation among those with normal cognition or mild cognitive impairment are of significant importance in delaying the onset of dementia and reducing dementia prevalence .
BACKGROUND	One challenge in these prevention trials is sample recruitment bias .
BACKGROUND	Those willing to volunteer for these trials could be socially active , in relatively good health , and have high educational levels and cognitive function .
BACKGROUND	These participants ' characteristics could reduce the generalizability of study results and , more importantly , mask trial effects .
BACKGROUND	We developed a randomized controlled trial to examine whether conversation-based cognitive stimulation delivered through personal computers , a webcam and the internet would have a positive effect on cognitive function among older adults with normal cognition or mild cognitive impairment .
BACKGROUND	To examine the selectivity of samples , we conducted a mass mail-in survey distribution among community-dwelling older adults , assessing factors associated with a willingness to participate in the trial .
METHODS	Two thousand mail-in surveys were distributed to retirement communities in order to collect data on demographics , the nature and frequency of social activities , personal computer use and additional health-related variables , and interest in the prevention study .
METHODS	We also asked for their contact information if they were interested in being contacted as potential participants in the trial .
RESULTS	Of 1,102 surveys returned ( 55.1 % response rate ) , 983 surveys had complete data for all the variables of interest .
RESULTS	Among them , 309 showed interest in the study and provided their contact information ( operationally defined as the committed with interest group ) , 74 provided contact information without interest in the study ( committed without interest group ) , 66 showed interest , but provided no contact information ( interest only group ) , and 534 showed no interest and provided no contact information ( no interest group ) .
RESULTS	Compared with the no interest group , the committed with interest group were more likely to be personal computer users ( odds ratio ( OR ) = 2.78 ) , physically active ( OR = 1.03 ) and had higher levels of loneliness ( OR = 1.16 ) .
CONCLUSIONS	Increasing potential participants ' familiarity with a personal computer and the internet before trial recruitment could increase participation rates and improve the generalizability of future studies of this type .
BACKGROUND	The trial was registered on 29 March 2012 at ClinicalTirals.gov ( ID number NCT01571427 ) .

###26095558
BACKGROUND	The Institute of Medicine has included the comparison of minimally invasive surgical techniques in its research agenda .
BACKGROUND	This study seeks to evaluate a model for the comparison of minimally invasive procedures using patient-reported outcomes .
METHODS	A double-blinded randomized controlled trial ( NCT01489436 ) was conducted .
METHODS	Baseline data were obtained , standardized anesthesia was induced , and patients were randomized to single-port ( SP ) or 4-port ( FP ) laparoscopic cholecystectomy .
METHODS	Perioperative care was standardized .
METHODS	The outcomes were pain ( Visual Analog Scale ) on postoperative day 1 ( primary ) and quality of life ( Patient-Reported Outcomes Measures Information System and Linear Analog Self-Assessment ) , serum cytokines , and heart rate variability ( secondary ) .
METHODS	Analysis was intention to treat .
METHODS	Using identical occlusive dressings , patients and the outcomes assessor remained blinded until postoperative day 2 .
RESULTS	Fifty-five patients were randomized to each arm .
RESULTS	There was no difference in demographics .
RESULTS	Visual Analog Scale pain score on postoperative day 1 was significantly different from baseline in each group ( SP : 1.6 1.9 to 4.2 2.4 vs FP : 1.8 2.3 to 4.2 2.2 ) , but not different from each other ( p = 0.83 ) .
RESULTS	Patients in the FP arm reported significantly less fatigue on postoperative day 7 than patients in the SP group ( 3.1 2.1 vs 4.2 2.2 ; p = 0.009 ) .
RESULTS	Fewer patients in the FP group required postoperative oral narcotics before discharge ( 40 % vs 60 % ; p = 0.056 ) .
RESULTS	Cytokines levels and heart rate variability were similar between arms .
RESULTS	In patients followed for > 1 year , no difference in umbilical hernia rates was noted .
CONCLUSIONS	Early postoperative quality of life data captured differences in fatigue , indicating improved recovery after FP within a controlled trial .
CONCLUSIONS	Physiologic measures were similar , suggesting that the differences between SP and FP are minimal .

###24377454
OBJECTIVE	The aim of this study was to evaluate the effects of pistachio nuts as an adjunct to diet and exercise on body composition , metabolic , inflammatory , and oxidative stress parameters in Asian Indians with metabolic syndrome .
METHODS	In this 24-wk randomized control trial , 60 individuals with the metabolic syndrome were randomized to either pistachio ( intervention group ) or control group ( diet as per weight and physical activity profile , modulated according to dietary guidelines for Asian Indians ) after 3 wk of a diet and exercise run in .
METHODS	In the first group , unsalted pistachios ( 20 % energy ) were given daily .
METHODS	A standard diet and exercise protocol was followed for both groups .
METHODS	Body weight , waist circumference ( WC ) , magnetic resonance imaging estimation of intraabdominal adipose tissue and subcutaneous abdominal adipose tissue , fasting blood glucose ( FBG ) , fasting serum insulin , glycosylated hemoglobin , lipid profile , high-sensitivity C-reactive protein ( hs-CRP ) , adiponectin , free fatty acids ( FFAs ) , tumor necrosis factor ( TNF ) - , leptin , and thiobarbituric acid reactive substances ( TBARS ) were assessed before and after the intervention .
RESULTS	Statistically significant improvement in mean values for various parameters in the intervention group compared with control group were as follows : WC ( P < 0.02 ) , FBG ( P < 0.04 ) , total cholesterol ( P < 0.02 ) , low-density lipoprotein cholesterol ( P < 0.006 ) , hs-CRP ( P < 0.05 ) , TNF - ( P < 0.03 ) , FFAs ( P < 0.001 ) , TBARS ( P < 0.01 ) , and adiponectin levels ( P < 0.001 ) .
CONCLUSIONS	A single food intervention with pistachios leads to beneficial effects on the cardiometabolic profile of Asian Indians with metabolic syndrome .

###24581030
OBJECTIVE	Multidetector CT ( MDCT ) is the established imaging modality in diagnostics of urolithiasis .
OBJECTIVE	The aim of iterative reconstruction ( IR ) is to allow for a radiation dose reduction while maintaining high image quality .
OBJECTIVE	This study evaluates its performance in MDCT for assessment of urolithiasis .
METHODS	Fifty-two patients underwent non-contrast abdominal MDCT .
METHODS	Twenty-six patients were referred to MDCT under suspicion of urolithiasis , and examined using a dose-reduced scan protocol ( RDCT ) .
METHODS	Twenty-six patients , who had undergone standard-dose MDCT , served as reference for radiation dose comparison .
METHODS	RDCT images were reconstructed using an IR system ( iDose4 , Philips Healthcare , Cleveland , OH , USA ) .
METHODS	Objective image noise ( OIN ) was recorded and five radiologists rated the subjective image quality independently .
METHODS	Radiation parameters were derived from the scan protocols .
RESULTS	The CTDIvol could be reduced by 50 % to 5.8 mGy ( P < 0.0001 ) .
RESULTS	The same reduction was achieved for DLP and effective dose to 25327mGy * cm ( P < 0.0001 ) and 3.90.4 mSv ( P < 0.0001 ) .
RESULTS	IR led to a reduction of the OIN of up to 61 % compared with classic filtered back projection ( FBP ) ( P < 0.0001 ) .
RESULTS	The OIN declined with increasing IR levels .
RESULTS	RDCT with FBP showed the lowest scores of subjective image quality ( 2.320.04 ) .
RESULTS	Mean scores improved with increasing IR levels .
RESULTS	iDose6 was rated with the best mean score ( 3.660.04 ) .
CONCLUSIONS	The evaluated IR-tool and protocol may be applied to achieve a considerable radiation dose reduction in MDCT for diagnostics of urolithiasis while maintaining a confident image quality .
CONCLUSIONS	Best image quality , suitable for evaluation of the entire abdomen concerning differential diagnoses , was achieved with iDose6 .

###25552412
OBJECTIVE	To evaluate the role of calcium infusion as a preventive strategy of ovarian hyperstimulation syndrome ( OHSS ) in women at high risk in in vitro fertilization ( IVF ) / intracytoplasmic sperm injection ( ICSI ) treatment cycles .
METHODS	Double-blinded randomized controlled trial .
METHODS	University hospital department of obstetrics and gynecology and private IVF center .
METHODS	Two hundred women at risk to develop OHSS undergoing IVF/ICSI treatment cycle .
METHODS	The intervention group ( group 1 ; n = 100 ) received intravenous infusion of 10 mL 10 % calcium gluconate in 100 mL 0.9 % saline solution on the day of ovum pick-up ( OPU ) and days 1 , 2 , and 3 after , and the placebo group ( group 2 ; n = 100 ) received 100 mL 0.9 % saline solution on the day of OPU and days 1 , 2 , and 3 after .
METHODS	Incidence of OHSS .
RESULTS	OHSS incidence was significantly higher in the placebo group ( group 2 ) than in the calcium infusion group ( group 1 ) : 23 ( 23 % ) vs. 7 ( 7 % ) ; moderate OHSS was significantly higher in group 2 than in group 1 : 8 ( 8 % ) vs. 1 ( 1 % ) ; and severe OHSS was significantly higher in group 2 than in group 1 : 4 ( 4 % ) vs. 0 .
CONCLUSIONS	Intravenous calcium infusion effectively reduced the incidence of OHSS development without reduction in the pregnancy rate .
BACKGROUND	NCT01427335 .

###25317990
BACKGROUND	Constitutive activation of the epidermal growth factor receptor ( EGFR ) is prevalent in epithelial cancers , particularly in non-small cell lung carcinoma ( NSCLC ) .
BACKGROUND	Mutations identified in EGFR predict the sensitivity to EGFR-targeted therapy .
BACKGROUND	Detection of these mutations is mainly based on tissue biopsy , which is invasive , expensive , and time consuming .
OBJECTIVE	Noninvasive , real-time , inexpensive detection and monitoring of EGFR mutations in patients with NSCLC is highly desirable .
METHODS	We developed a novel core technology , electric field-induced release and measurement ( EFIRM ) , which relies on a multiplexible electrochemical sensor that can detect EGFR mutations directly in bodily fluids .
RESULTS	We established EFIRM for the detection of the EGFR mutations in vitro and correlated the results with tumor size from xenografted mice .
RESULTS	In clinical application , we demonstrated that EFIRM could detect EGFR mutations in the saliva and plasma of 22 patients with NSCLC .
RESULTS	Finally , a blinded test was performed on saliva samples from 40 patients with NSCLC .
RESULTS	The receiver operating characteristic analysis indicated that EFIRM detected the exon 19 deletion with an area under the curve of 0.94 and the L858R mutation with an area under the curve of 0.96 .
CONCLUSIONS	Our data indicate that EFIRM is effective , accurate , rapid , user-friendly , and cost effective for the detection of EGFR mutations in the saliva of patients with NSCLC .
CONCLUSIONS	We termed this saliva-based EGFR mutation detection ( SABER ) .

###25150812
BACKGROUND	Postcancer fatigue is a frequently occurring problem , impairing quality of life .
BACKGROUND	Little is known about ( neuro ) physiological factors determining postcancer fatigue .
BACKGROUND	It may be hypothesized that postcancer fatigue is characterized by low peripheral muscle fatigue and high central muscle fatigue .
OBJECTIVE	The aims of this study were to examine whether central and peripheral muscle fatigue differ between fatigued and non-fatigued cancer survivors and to examine the effect of cognitive behavioral therapy ( CBT ) on peripheral and central muscle fatigue of fatigued cancer survivors in a randomized controlled trial .
METHODS	Sixteen fatigued patients in the intervention group ( CBT ) and eight fatigued patients in the waiting list group were successfully assessed at baseline and six months later .
METHODS	Baseline measurements of 20 fatigued patients were compared with 20 non-fatigued patients .
METHODS	A twitch interpolation technique and surface electromyography were applied , respectively , during sustained contraction of the biceps brachii muscle .
RESULTS	Muscle fiber conduction velocity ( MFCV ) and central activation failure ( CAF ) were not significantly different between fatigued and non-fatigued patients .
RESULTS	Change scores of MFCV and CAF were not significantly different between patients in the CBT and waiting list groups .
RESULTS	Patients in the CBT group reported a significantly larger decrease in fatigue scores than patients in the waiting list group .
CONCLUSIONS	Postcancer fatigue is neither characterized by abnormally high central muscle fatigue nor by low peripheral muscle fatigue .
CONCLUSIONS	These findings suggest a difference in the underlying physiological mechanism of postcancer fatigue vs. other fatigue syndromes .

###25073037
BACKGROUND	Reactivation of human herpesvirus ( HHV ) -6 and HHV-7 has been linked to various posttransplant adverse events through immunomodulatory effects .
BACKGROUND	The potential utility of monitoring for HHV-6 and HHV-7 viremia remains unclear .
METHODS	In this clinical trial , 129 liver transplant recipients were randomized to be monitored in real-time for HHV-6 and HHV-7 viremia by polymerase chain reaction at regular intervals from 0 to 12 weeks after transplantation ( `` monitoring '' group ) or to undergo usual care ( `` no-monitoring '' group ) .
METHODS	Therapeutic intervention for a positive polymerase chain reaction result included reduction in immunosuppression and preemptive antiviral therapy , at the discretion of the attending team .
METHODS	The primary outcome was a composite of adverse events indirectly attributable to viral reactivation ( including opportunistic infection , graft rejection and severe hepatitis C virus recurrence ) .
RESULTS	In the `` monitoring '' group , HHV-6 and HHV-7 viremia occurred in 23 of 64 patients ( 35.9 % ) and 21 of 64 patients ( 32.8 % ) patients , respectively .
RESULTS	We found no cases of symptomatic HHV-6 and HHV-7 disease .
RESULTS	Some therapeutic interventions were performed in 59.1 % of viremic episodes .
RESULTS	There were no differences in cumulative incidence of the primary outcome between the `` monitoring '' and `` no-monitoring '' groups at 1 year ( 58.7 % vs. 52.3 % ; odds ratio , 0.77 ; 95 % confidence interval , 0.38-1 .55 ) or at 5 years after transplantation ( 79.0 % vs. 70.3 % ; odds ratio , 0.63 ; 95 % confidence interval , 0.28-1 .42 ) .
RESULTS	However , we found a trend toward a lower incidence of graft rejection at year 1 in the `` monitoring '' group ( 30.2 % vs. 44.6 % ; P = 0.091 ) .
CONCLUSIONS	In this first trial , no benefit could be demonstrated from routine monitoring of HHV-6 and HHV-7 viremia in graft or patient outcome after liver transplantation .

###25058962
OBJECTIVE	To compare therapeutic effects between suspine rotation and flexion manipulation for treating lumbar disc herniation .
METHODS	From December 2008 to January 2011 , 134 patients with lumbar disc herniation were treated , including 74 males and 60 females , ranging in age from 17 to 67 years ,33 patients with age over 50 years old .
METHODS	According to diagnosis the ladder of the 9 cases bulging type , 74 hernia type , 51 cases free type .
METHODS	The patients were randomly divided into treatment group ( 69 cases ) and control group ( 65 cases ) .
METHODS	All the patients were treated with the three-dimensional computer-controlled traction therapeutic apparatus , with continued traction for 20 minutes .
METHODS	After traction , flexion manipulation and rotat-ing manipulation were respectively adopted in treatment group and control group ( on alternate days one time , 3 times as a course of treatment ) .
METHODS	The symptoms and signs ( including back pain and discomfort , lower limb pain and numbness , powerless urination and defecation , numbness in perineum , straight-leg raising degree , ability of lower extremity walking , work and live ) of patients were observed after treatment .
RESULTS	All patients were followed up for 0.5 to 6 months with an average of 1.1 months .
RESULTS	After treatment , the symptoms and signs of patients have significantly improved ( P < 0.01 ) , but the symptomes of powerless urination and defecation , numbness in perineum was not improved obviously ( P > 0.05 ) .
RESULTS	Forty-two of 69 patients in treatment group got excellent result , moderate in 20 , poor in 7 ; Twenty of 65 patients in control group got excellent result , moderate in 25 , poor in 20 .
CONCLUSIONS	The whole effect of lumbar backwards rotation manipulation is more satisfactory than flexsion manipulation for treating lumbar intervertebral disc herniation .
CONCLUSIONS	But spinning force and times should be noticed .

###24226711
OBJECTIVE	Gastroscopy and gastroscopic mucosal biopsy techniques have become increasingly used as of late for evaluating symptoms presumed to be originated in the upper gastrointestinal tract .
OBJECTIVE	Patients often complain however of abdominal pain post-gastroscopic mucosal biopsy , and this study aimed to explore the necessity of acid inhibitors when abdominal pain worsened .
METHODS	In this randomized , double-blinded , placebo-controlled study , we screened 272 participants , and ultimately enrolled 200 into the study .
METHODS	These 200 participants were randomly assigned in a 1:1 ratio to receive acid inhibitors ( esomeprazole , treatment group , n = 100 ; dose ,20 mg/d ) or matched placebo ( control group , n = 100 ) for 3 days post-gastroscopic mucosal biopsy .
METHODS	The presence of abdominal pain was observed pre-and post-gastroscopy , and the therapeutic effect of esomeprazole was assessed .
METHODS	This study was registered at the Chinese clinical trial registry as ChiCTR-TRC-00000500 .
RESULTS	Ten subjects were lost to followup ( 4 in treatment group ; 6 in the control group ) .
RESULTS	There was no significant difference in the number of subjects with aggravating abdominal pain ( treatment 29.2 % vs. control 22.3 % ; p > 0.05 ) between the two groups .
RESULTS	Esomeprazole did not significantly ( p > 0.05 ) affect the rate of abdominal pain within 24 h ( treatment 27.1 % vs. control 19.1 % ) , 48 h ( treatment 40.6 % vs. control 27.7 % ) , and 96 h ( treatment 43.8 % vs. control 34.0 % ) on abdominal pain in all in the evaluated subjects .
RESULTS	Between the two groups however , a statistically significant difference ( p < 0.05 ) was found on overall effective treatment rates at 48 h ( treatment 92.9 % vs. control 66.7 % ) and at 96 h ( treatment 100 % vs. control 81 % ) in the subjects with worsened abdominal pain .
CONCLUSIONS	The study suggests that routine prophylaxis with acid inhibitors is not recommended for all patients post-gastroscopic mucosal biopsy , however acid inhibitors should be administered for patients with aggravating abdominal pain .

###24982459
OBJECTIVE	To characterize relationships between specific immune cell subsets in bone marrow ( BM ) or granulocyte colony-stimulating factor-mobilized peripheral blood ( PB ) stem cells collected from unrelated donors and clinical outcomes of patients undergoing transplantation in BMTCTN 0201 .
METHODS	Fresh aliquots of 161 BM and 147 PB stem-cell allografts from North American donors randomly assigned to donate BM or PB stem cells and numbers of transplanted cells were correlated with overall survival ( OS ) , relapse , and graft-versus-host disease ( GvHD ) .
RESULTS	Patients with evaluable grafts were similar to all BMTCTN 0201 patients .
RESULTS	The numbers of plasmacytoid dendritic cells ( pDCs ) and nave T cells ( Tns ) in BM allografts were independently associated with OS in multivariable analyses including recipient and donor characteristics , such as human leukocyte antigen mismatch , age , and use of antithymocyte globulin .
RESULTS	BM recipients of > median number of pDCs , nave CD8 ( + ) T cells ( CD8Tns ) , or nave CD4 ( + ) T cells ( CD4Tns ) had better 3-year OS ( pDCs , 56 % v 35 % ; P = .025 ; CD8Tns , 56 % v 37 % ; P = .012 ; CD4Tns , 55 % v 37 % ; P = .009 ) .
RESULTS	Transplantation of more BM Tns was associated with less grade 3 to 4 acute GvHD but similar rates of relapse .
RESULTS	Transplantation of more BM pDCs was associated with fewer deaths resulting from GvHD or from graft rejection .
RESULTS	Analysis of PB grafts did not identify a donor cell subset significantly associated with OS , relapse , or GvHD .
CONCLUSIONS	Donor immune cells in BM but not PB stem-cell grafts were associated with survival after unrelated-donor allogeneic hematopoietic stem-cell transplantation .
CONCLUSIONS	The biologic activity of donor immune cells in allogeneic transplantation varied between graft sources .
CONCLUSIONS	Donor grafts with more BM-derived Tns and pDCs favorably regulated post-transplantation immunity in allogeneic hematopoietic stem-cell transplantation .

###24824360
OBJECTIVE	Tryptophan not only is an amino acid essential to protein synthesis but also serves as a precursor in 2 important metabolic pathways : the serotonin and the kynurenine pathways .
OBJECTIVE	Tryptophan is related to sleeping patterns .
OBJECTIVE	The objective of the present study was to determine the tryptophan requirement of term infants using the indicator amino acid oxidation ( IAAO ) method with L - [ 1-C ] phenylalanine as the indicator .
METHODS	Enterally fed infants were randomly assigned to tryptophan intakes ranging from 0.5 to 73mgkgday as part of an elemental diet .
METHODS	After 1-day adaptation to the test diet , [ C ] bicarbonate and L - [ 1-C ] phenylalanine tracers were given enterally .
METHODS	Breath samples were collected at baseline and during isotopic plateaus .
METHODS	The mean tryptophan requirement was determined by using the biphasic linear regression crossover analysis on the fraction of CO2 recovery from L - [ 1-C ] phenylalanine oxidation ( FCO2 ) .
METHODS	Data are presented as meanstandard deviation .
RESULTS	A total of 30 term neonates ( gestational age 391 weeks ) were studied at 94 days .
RESULTS	FCO2 decreased until a tryptophan intake of 15mgkgday ; additional increases in tryptophan intake did not affect FCO2 .
RESULTS	Mean requirement was determined to be 15mgkgday .
CONCLUSIONS	The mean tryptophan requirement for elemental formula-fed term infants is 15mgkgday .
CONCLUSIONS	This requirement is lower than the present recommended intake of 29mgkgday , which is based on the average intake of a breastfed infant .

###24650850
BACKGROUND	Although the surgical and oncological therapies of primary spinal tumors ( PSTs ) have changed significantly over the last few decades , the prognosis of this rare disease is still poor .
BACKGROUND	The decision-making process in the multidisciplinary management is handicapped by the lack of large-scale population-based prognostic studies .
OBJECTIVE	The objective of the present study was to investigate preoperative factors associated with PST mortality and to develop a predictive scoring system of poor survival .
METHODS	This is a large-scale ambispective cohort study .
METHODS	The study included 323 consecutive patients with PSTs , treated surgically over an 18-year period at a tertiary care spine referral center for a population of 10 million .
METHODS	Survival was the outcome measure .
METHODS	Patients were randomly divided into a training cohort ( n = 273 ) and a validation cohort ( n = 50 ) .
METHODS	In the training cohort , 12 preoperative factors were investigated using Cox proportional hazard models .
METHODS	Based on the mortality-related variables , a simple scoring system of mortality was created , and three groups of patients were identified .
METHODS	Kaplan-Meier and log-rank analyses were used to compare the survival in the three groups .
METHODS	The model performance was assessed by measuring the discriminative ability ( c-index ) of the model and by applying a pseudo-R ( 2 ) goodness-of-fit test ( Nagelkerke R ( 2 ) , RN ( 2 ) ) .
METHODS	Internal validation was performed using bootstrapping in the training cohort and assessing the discrimination and explained variation of the model in the validation cohort .
RESULTS	Patient age , spinal region , tumor grade , spinal pain , motor deficit , and myelopathy/cauda equina syndrome were significantly associated with poor survival in the multivariate analysis ( p < .001 , RN ( 2 ) = 0.799 ) .
RESULTS	Based on these variables , we developed the Primary Spinal Tumor Mortality Score ( PSTMS ) , where an eight-point scale was divided into three categories ( low , medium , and high mortality ) .
RESULTS	The three PSTMS categories were significantly associated with the overall survival ( p < .001 , RN ( 2 ) = 0.811 , c = 0.82 ) .
RESULTS	The model performance remained similarly high in the validation cohort ( RN ( 2 ) = 0.831 , c = 0.81 ) .
CONCLUSIONS	The present study identifies six predictive variables for mortality in PSTs .
CONCLUSIONS	Using these six variables , an easy-to-use scoring system was developed that can be applied to the estimation of postoperative survival in all types of PST patients .

###24311014
OBJECTIVE	To prospectively assess the added value of gadolinium-enhanced and diffusion-weighted ( DWI ) MRI for the diagnosis of pelvic recurrence from colorectal cancer ( CRC ) .
METHODS	Fifty-two patients with suspected pelvic recurrence from CRC underwent pelvic MRI with T2-weighted ( `` T2 '' ) , gadolinium-enhanced fat-suppressed T1-weighted ( `` gadolinium '' ) and DWI MR sequences .
METHODS	Three readers ( senior radiologist : R1 , two residents : R2 , R3 ) scored the likelihood of recurrence on `` T2 , '' `` T2 + DWI , '' and `` T2 + Gadolinium . ''
RESULTS	Twenty-seven patients had 42 sites of pelvic recurrence .
RESULTS	On `` T2 , '' R1 achieved AUC of .95 , sensitivity 88.4 % , specificity 95.2 % .
RESULTS	For R2 , these figures were .89 , 81.4 % , 90.5 % , for R3 .90 , 83.7 % , 76 % .
RESULTS	Both Gadolinium injection and DWI significantly improved AUCs for residents but not for the senior radiologist : up to .988 ( R2 , P = 0.006 ) and to .98 ( R3 , P = 0.01 ) with DWI and to .96 ( R2 , P = 0.04 ) , .98 ( R3 , P = 0.01 ) after gadolinium .
RESULTS	All readers achieved slightly better AUCs with `` T2 + DWI '' than with `` T2 + Gadolinium '' but not significantly ( P = 0.68 , P = 0.11 , P = 0.3 ; respectively ) .
CONCLUSIONS	For diagnosis of pelvic recurrence from CRC , both DWI and gadolinium-enhanced MRI significantly increase diagnostic performances compared with `` T2 '' MRI for residents .
CONCLUSIONS	DWI may be helpful in patients with contra-indications to intravenous administration of gadolinium .

###25158709
BACKGROUND	Upper lip wounds that lie perpendicular to the relaxed skin tension lines are subjected to repetitive dynamic tension caused by the orbicularis oris muscle and are susceptible to unsatisfactory scarring .
METHODS	In this double-blind , randomized , vehicle-controlled , prospective trial , 60 consecutive patients with unilateral cleft lip undergoing primary cheiloplasties between August of 2011 and June of 2012 were randomized to receive botulinum toxin type A or vehicle injections into the subjacent orbicularis oris muscle immediately after wound closure .
METHODS	Scars were assessed after 6 months using the Vancouver Scar Scale , photographic visual analogue scale , and photographic scar width measurements .
RESULTS	Fifty-nine patients completed the trial .
RESULTS	Measurements of scar widths at two defined points revealed significantly better visual analogue scale scores and narrower scars in the experimental group .
RESULTS	However , Vancouver Scar Scale assessments were similar between groups .
CONCLUSIONS	Botulinum toxin injections into the subjacent orbicularis oris muscle produced better appearing and narrower cheiloplasty scars , but provided no additional benefits in terms of scar pigmentation , vascularity , pliability , or height .
METHODS	Therapeutic , II .

###25170231
OBJECTIVE	To investigate the efficacy of tandospirone in patients with irritable bowel syndrome-diarrhea ( IBS-D ) and anxiety in a prospective , randomized , controlled study .
METHODS	Two hundred patients with IBS-D and moderate anxiety were randomized to receive pinaverium and tandospirone ( arm A ) or pinaverium and placebo ( arm B ) .
METHODS	Tandospirone or placebo was given thrice daily at a fixed dose of 10 mg and pinaverium was given thrice daily at a fixed dose of 50 mg .
METHODS	The duration of treatment was 8 wk .
METHODS	Patients were assessed for abdominal pain and diarrhea .
METHODS	Anxiety was evaluated using the Hamilton Rating Scale for Anxiety ( HAM-A ) .
METHODS	The primary study endpoints were response rates for abdominal pain and diarrhea .
METHODS	The secondary study endpoints were response rates for anxiety .
METHODS	Adverse events were also evaluated .
RESULTS	One hundred and seventy of 200 patients ( 82 patients in arm A and 88 patients in arm B ) completed the study .
RESULTS	Demographic and baseline characteristics of the 200 participants were comparable in the two arms .
RESULTS	At week 8 , the overall response rate for abdominal pain and diarrhea was 52.0 % for arm A and 37.0 % for arm B ( P < 0.05 ) .
RESULTS	The HAM-A score showed that the response rate was 61.0 % for arm A and 21.0 % for arm B ( P < 0.01 ) .
RESULTS	The treatments were well tolerated and no significant adverse events were reported .
CONCLUSIONS	Tandospirone is effective and can be combined with pinaverium in IBS-D patients with anxiety .

###24606612
BACKGROUND	Provision of essential newborn care ( ENC ) can save many newborn lives in poor resource settings but coverage is far from universal and varies by country and place of delivery .
BACKGROUND	Understanding gaps in current coverage and where coverage is good , in different contexts and places of delivery , could make a valuable contribution to the future design of interventions to reduce neonatal mortality .
BACKGROUND	We sought to describe the coverage of essential newborn care practices for births in institutions , at home with a skilled birth attendant , and at home without a skilled birth attendant ( SBA ) in rural areas of Bangladesh , Nepal , and India .
METHODS	We used data from the control arms of four cluster randomised controlled trials in Bangladesh , Eastern India and from Makwanpur and Dhanusha districts in Nepal , covering periods from 2001 to 2011 .
METHODS	We used these data to identify essential newborn care practices as defined by the World Health Organization .
METHODS	Each birth was allocated to one of three delivery types : home birth without an SBA , home birth with an SBA , or institutional delivery .
METHODS	For each study , we calculated the observed proportion of births that received each care practice by delivery type with 95 % confidence intervals , adjusted for clustering and , where appropriate , stratification .
RESULTS	After exclusions , we analysed data for 8939 births from Eastern India , 27 553 births from Bangladesh , 6765 births from Makwanpur and 15 344 births from Dhanusha .
RESULTS	Across all study areas , coverage of essential newborn care practices was highest in institutional deliveries , and lowest in home non-SBA deliveries .
RESULTS	However , institutional deliveries did not provide universal coverage of the recommended practices , with relatively low coverage ( 20 % -70 % ) across all study areas for immediate breastfeeding and thermal care .
RESULTS	Institutions in Bangladesh had the highest coverage for almost all care practices except thermal care .
RESULTS	Across all areas , fewer than 20 % of home non-SBA deliveries used a clean delivery kit , the use of plastic gloves was very low and coverage of recommended thermal care was relatively poor .
RESULTS	There were large differences between study areas in handwashing , immediate breastfeeding and delayed bathing .
CONCLUSIONS	There remains substantial scope for health facilities to improve thermal care for the newborn and to encourage immediate and exclusive breastfeeding .
CONCLUSIONS	For unattended home deliveries , increased handwashing , use of clean delivery kits and basic thermal care offer great scope for improvement .

###25377429
OBJECTIVE	To evaluate the safety , tolerability , and pharmacokinetics ( PK ) of pregabalin as adjunctive therapy in children with refractory partial seizures .
METHODS	This was a phase 1 , randomized , placebo-controlled , parallel-group , escalating-dose , multiple-dose study comprising a 7-day , double-blind treatment period and a single-blind , single dose of pregabalin administered to all children on day 8 .
METHODS	Children in four age cohorts ( 1-23 months , 2-6 , 7-11 , and 12-16 years ) received one of four doses of pregabalin ( 2.5 , 5 , 10 , or 15 mg/kg/day ) or placebo .
METHODS	Safety and tolerability were assessed throughout the study .
METHODS	Steady-state and single-dose PK parameters on day 8 were analyzed using standard noncompartmental procedures .
RESULTS	Sixty-five children received at least one dose of treatment .
RESULTS	Four pregabalin-treated children discontinued treatment , three of whom received 15 mg/kg/day .
RESULTS	Two children experienced serious adverse events , one of whom received pregabalin 15 mg/kg/day .
RESULTS	During double-blind treatment , the most common adverse events reported in the pregabalin-treated population were somnolence ( 27.1 % ) and dizziness ( 12.5 % ) .
RESULTS	Steady-state pregabalin peak and total exposure in each age cohort appeared to increase linearly with dose .
RESULTS	Apparent oral clearance ( CL/F ) was directly related to creatinine clearance , consistent with adults .
RESULTS	CL/F normalized for body weight was 43 % higher in patients weighing < 30 kg .
RESULTS	Steady-state and single-dose PK were consistent .
CONCLUSIONS	Pregabalin at doses up to 10 mg/kg/day in children aged 1 month to 16 years , and at doses up to 15 mg/kg/day in those aged < 6 years , demonstrated acceptable safety and tolerability .
CONCLUSIONS	For children weighing < 30 kg , a dose increase of 40 % ( mg/kg dosing ) is required to achieve comparable exposure with adults or children weighing 30 kg .
CONCLUSIONS	These data will inform dose selection in phase 3 trials of the efficacy and safety of adjunctive pregabalin in children with refractory partial seizures .

###24225155
BACKGROUND	Intraoperative radiotherapy with electrons allows the substitution of conventional postoperative whole breast irradiation with one session of radiotherapy with the same equivalent dose during surgery .
BACKGROUND	However , its ability to control for recurrence of local disease required confirmation in a randomised controlled trial .
METHODS	This study was done at the European Institute of Oncology ( Milan , Italy ) .
METHODS	Women aged 48-75 years with early breast cancer , a maximum tumour diameter of up to 25 cm , and suitable for breast-conserving surgery were randomly assigned in a 1:1 ratio ( using a random permuted block design , stratified for clinical tumour size [ < 10 cm vs 10-14 cm vs 15 cm ] ) to receive either whole-breast external radiotherapy or intraoperative radiotherapy with electrons .
METHODS	Study coordinators , clinicians , and patients were aware of the assignment .
METHODS	Patients in the intraoperative radiotherapy group received one dose of 21 Gy to the tumour bed during surgery .
METHODS	Those in the external radiotherapy group received 50 Gy in 25 fractions of 2 Gy , followed by a boost of 10 Gy in five fractions .
METHODS	This was an equivalence trial ; the prespecified equivalence margin was local recurrence of 75 % in the intraoperative radiotherapy group .
METHODS	The primary endpoint was occurrence of ipsilateral breast tumour recurrences ( IBTR ) ; overall survival was a secondary outcome .
METHODS	The main analysis was by intention to treat .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01849133 .
RESULTS	1305 patients were randomised ( 654 to external radiotherapy and 651 to intraoperative radiotherapy ) between Nov 20 , 2000 , and Dec 27 , 2007 .
RESULTS	After a medium follow-up of 58 years ( IQR 41-77 ) , 35 patients in the intraoperative radiotherapy group and four patients in the external radiotherapy group had had an IBTR ( p < 00001 ) .
RESULTS	The 5-year event rate for IBRT was 44 % ( 95 % CI 27-61 ) in the intraoperative radiotherapy group and 04 % ( 00-10 ) in the external radiotherapy group ( hazard ratio 93 [ 95 % CI 33-263 ] ) .
RESULTS	During the same period , 34 women allocated to intraoperative radiotherapy and 31 to external radiotherapy died ( p = 059 ) .
RESULTS	5-year overall survival was 968 % ( 95 % CI 953-983 ) in the intraoperative radiotherapy group and 969 % ( 955-983 ) in the external radiotherapy group .
RESULTS	In patients with data available ( n = 464 for intraoperative radiotherapy ; n = 412 for external radiotherapy ) we noted significantly fewer skin side-effects in women in the intraoperative radiotherapy group than in those in the external radiotherapy group ( p = 00002 ) .
CONCLUSIONS	Although the rate of IBTR in the intraoperative radiotherapy group was within the prespecified equivalence margin , the rate was significantly greater than with external radiotherapy , and overall survival did not differ between groups .
CONCLUSIONS	Improved selection of patients could reduce the rate of IBTR with intraoperative radiotherapy with electrons .
BACKGROUND	Italian Association for Cancer Research , Jacqueline Seroussi Memorial Foundation for Cancer Research , and Umberto Veronesi Foundation .

###25106453
BACKGROUND	We aimed to evaluate the effect of a decision aid ( DA ) with information only compared to a DA with values clarification exercise ( VCE ) , and to study the role of personality and information seeking style in DA-use , decisional conflict ( DC ) and knowledge .
METHODS	Two scenario-based experiments were conducted with two different groups of healthy female participants .
METHODS	Dependent measures were : DC , knowledge , and DA-use ( time spent , pages viewed , VCE used ) .
METHODS	Respondents were randomized between a DA with information only ( VCE - ) and a DA with information plus a VCE ( VCE + ) ( experiment 1 ) , or between information only ( VCE - ) , information plus VCE without referral to VCE ( VCE + ) , and information plus a VCE with specific referral to the VCE , requesting participants to use the VCE ( VCE + + ) ( experiment 2 ) .
METHODS	In experiment 2 we additionally measured personality ( neuroticism/conscientiousness ) and information seeking style ( monitoring/blunting ) .
RESULTS	Experiment 1 .
RESULTS	There were no differences in DC , knowledge or DA-use between VCE - ( n = 70 ) and VCE + ( n = 70 ) .
RESULTS	Both DAs lead to a mean gain in knowledge from 39 % at baseline to 73 % after viewing the DA .
RESULTS	Within VCE + , VCE-users ( n = 32 , 46 % ) reported less DC compared to non-users .
RESULTS	Since there was no difference in DC between VCE - and VCE + , this is likely an effect of VCE-use in a self-selected group , and not of the VCE per se .
RESULTS	Experiment 2 .
RESULTS	There were no differences in DC or knowledge between VCE - ( n = 65 ) , VCE + ( n = 66 ) , VCE + + ( n = 66 ) .
RESULTS	In all groups , knowledge increased on average from 42 % at baseline to 72 % after viewing the DA .
RESULTS	Blunters viewed fewer DA-pages ( R = 0.38 , p < .001 ) .
RESULTS	More neurotic women were less certain ( R = 0.18 , p < .01 ) and felt less supported in decision making ( R = 0.15 , p < .05 ) ; conscientious women felt more certain ( R = -0.15 , p < .05 ) and had more knowledge after viewing the DA ( R = 0.15 , p < .05 ) .
CONCLUSIONS	Both DAs lead to increased knowledge in healthy populations making hypothetical decisions , and use of the VCE did not improve knowledge or DC .
CONCLUSIONS	Personality characteristics were associated to some extent with DA-use , information seeking styles with aspects of DC .
CONCLUSIONS	More research is needed to make clear recommendations regarding the need for tailoring of information provision to personality characteristics , and to assess the effect of VCE use in actual patients .

###25238506
BACKGROUND	Acute viral tonsillitis is an upper respiratory tract infection prevalent in school-aged children .
BACKGROUND	Because this condition is self-limiting , conventional treatment options are usually palliative .
BACKGROUND	Homeopathic remedies are a useful alternative to conventional medications in acute uncomplicated upper respiratory tract infections in children , offering earlier symptom resolution , cost-effectiveness , and fewer adverse effects .
BACKGROUND	This study aimed to determine the efficacy of a homeopathic complex on the symptoms of acute viral tonsillitis in African children in South Africa .
METHODS	This was a randomized , double-blind , placebo-controlled , 6-day pilot study .
METHODS	Thirty children , age 6 to 12 years , with acute viral tonsillitis were recruited from a primary school in Gauteng , South Africa .
METHODS	Participants took two tablets of the medication four times daily .
METHODS	The treatment group received lactose tablets medicated with the homeopathic complex ( Atropa belladonna D4 , Calcarea phosphoricum D4 , Hepar sulphuris D4 , Kalium bichromat D4 , Kalium muriaticum D4 , Mercurius protoiodid D10 , and Mercurius biniodid D10 ) .
METHODS	The placebo consisted of the unmedicated vehicle only .
METHODS	The Wong-Baker FACES Pain Rating Scale measured pain intensity , and a Symptom Grading Scale assessed changes in tonsillitis signs and symptoms .
RESULTS	The treatment group had a statistically significant improvement in the following symptoms compared with the placebo group : pain associated with tonsillitis , pain on swallowing , erythema and inflammation of the pharynx , and tonsil size .
CONCLUSIONS	The homeopathic complex used in this study exhibited significant anti-inflammatory and pain-relieving qualities in children with acute viral tonsillitis .
CONCLUSIONS	No patients reported any adverse effects .
CONCLUSIONS	These preliminary findings are promising ; however , the sample size was small and therefore a definitive conclusion can not be reached .
CONCLUSIONS	A larger , more inclusive research study should be undertaken to verify the findings of this study .

###24555619
OBJECTIVE	Endovascular stenting is a safe , effective treatment of hepatic artery stenosis after liver transplant , but no detailed evaluation has been completed of changes in ultrasound monitoring parameters after stenting .
OBJECTIVE	This study aims to improve poststenting surveillance by delineating the expected postoperative findings .
METHODS	Thirty-one stent procedures were performed at our institution for hepatic artery stenosis after liver transplant between October 2010 and October 2012 .
METHODS	Of these , 28 ( 90 % ) were technically successful , of which 23 met the minimum follow-up time ( 76 days , defined by the earliest diagnosed restenosis ) .
METHODS	These patients were followed with serial ultrasound , per the following schedule : within 1 week of stenting , 3 months after stenting , 6 months after stenting , and every 6 months thereafter ; additional , unscheduled examinations were frequently performed when indicated on the basis of deterioration of clinical and laboratory status .
METHODS	Follow-up examinations ( mean , 268 days total follow-up ) were compared with prestenting examinations to evaluate changes in peak systolic velocity ( PSV ) , resistive index ( RI ) , and tardus-parvus waveforms .
METHODS	Data were analyzed to determine a normal range for postprocedure values and time course of change in values .
RESULTS	Of the 23 patients , six experienced restenosis .
RESULTS	In all patients , mean PSV decreased by 124 cm/s , and mean RI increased by 0.13 within 48 hours after stenting .
RESULTS	PSV differed between patency and restenosis groups only at more than 90 days after stenting ( mean PSV , 234 and 400 cm/s , respectively ) , with PSV above 300 cm/s serving as a high-sensitivity threshold for the determination of restenosis .
RESULTS	Prestenting RI of below 0.40 had a strong correlation with restenosis .
RESULTS	Poststenting RI differed between patency and restenosis groups only at more than 48 hours after stenting , with RI of below 0.55 having a strong correlation with restenosis .
RESULTS	Tardus-parvus waveform resolution was often delayed well beyond 48 hours after stenting , and time to tardus-parvus waveform resolution had no correlation with patency or restenosis .
CONCLUSIONS	Ultrasound is convenient and useful to follow stents in hepatic artery stenosis after liver transplant .
CONCLUSIONS	Prestenting hemodynamics can have value in predicting restenosis .
CONCLUSIONS	Diagnosis of restenosis can be made with RI and PSV , whereas resolution time of tardus-parvus waveform is of less concern .
CONCLUSIONS	These parameters can guide which patients require closer monitoring and aggressive treatment .

###25671951
BACKGROUND	Cardiac surgery is associated with excessive bleeding that is as a result of coagulopathy caused by cardiopulmonary bypass .
BACKGROUND	We evaluated the effect of two different modalities for administering similar doses of tranexamic acid on bleeding following primary elective coronary artery bypass grafting ( CABG ) .
METHODS	In the randomized control trial .
METHODS	137 patients scheduled for CABG were randomized to two groups applying different modalities of tranexamic acid administration ( bolus injection of 30 mg/kg vs. continuous infusion ) .
METHODS	Blood loss until removal of chest tubes was the primary outcome measure ; we also recorded and assessed blood products transfused , and length of ICU stay .
RESULTS	Both the groups were comparable at baseline .
RESULTS	Trends toward transfusion differences between groups were not statistically significant .
RESULTS	No differences in length of ICU stay , morbidity or mortality were found .
CONCLUSIONS	In CABG surgery , the use of either method for administering similar doses of tranexamic acid leads to a similarl reduction in postoperative mediastinal bleeding .

###25451894
OBJECTIVE	This study was conducted to evaluate the efficacy of extracorporeal shock wave therapy ( ESWT ) on the healing rate , wound surface area and wound bed preparation in chronic diabetic foot ulcers ( DFU ) .
METHODS	Thirty eight patients with 45 chronic DFU were randomly assigned into ; the ESWT-group ( 19 patients/24 ulcers ) and the control-group ( 19 patients/21 ulcers ) .
METHODS	Blinded therapist measured wound surface area ( WSA ) , the percentage of reduction in the WSA , rate of healing and wound bed preparation at baseline , after the end of the interventions ( W8 ) , and at 20-week follow-up ( W20 ) .
METHODS	The ESWT group received shock wave therapy twice per week for a total of eight treatments .
METHODS	Each ulcer was received ESWT at a frequency of 100 pulse/cm ( 2 ) , and energy flux density of 0.11 mJ/cm ( 2 ) .
METHODS	All patients received standardized wound care consisting of debridement , blood-glucose control agents , and footwear modification for pressure reduction .
RESULTS	The overall clinical results showed completely healed ulcers in 33.3 % and 54 % in ESWT-groups and 14.28 % and 28.5 % in the control group after intervention ( W8 ) , and at follow-up ( W20 ) respectively .
RESULTS	The average healing time was significantly lower ( 64.5 8.06 days vs 81.17 4.35 days , p < 0.05 ) in the ESWT-group compared with the control group .
CONCLUSIONS	ESWT-treated ulcers had a significant reduction in wound size and median time required for ulcer healing , with no adverse reactions .
CONCLUSIONS	So , the ESWT is advocated as an adjunctive therapy in chronic diabetic wound .

###24326604
OBJECTIVE	Many African infants fail to receive their diagnostic HIV molecular test results and subsequently , antiretroviral therapy ( ART ) .
OBJECTIVE	To determine whether a point-of-care molecular HIV test increases ART access for hospitalized Malawian infants , we simulated a point-of-care test using rapid HIV RNA polymerase chain reaction ( Rapid PCR ) and compared patient outcomes with an optimized standard care that included assessment with the World Health Organization clinical algorithm for HIV infection plus a DNA PCR with a turnaround time of several weeks ( standard care ) .
METHODS	Randomized controlled trial .
METHODS	Hospitalized HIV-exposed Malawian infants aged < 12 months were randomized into Rapid PCR or standard care .
METHODS	Rapid PCR infants obtained molecular test results within 48 hours to facilitate immediate ART , similar to a point-of-care test .
METHODS	Standard care infants meeting clinical criteria were also offered inpatient ART .
METHODS	The primary outcome was appropriate in-hospital ART for DNA or RNA PCR-confirmed HIV-infected infants .
RESULTS	Three hundred infants were enrolled .
RESULTS	A greater proportion of HIV-infected infants receiving Rapid PCR , versus standard care , started inpatient ART ( 72.3 % vs 47.8 % , P = 0.016 ) .
RESULTS	Among molecular test-negative infants , 26.9 % receiving standard care unnecessarily initiated inpatient ART , versus 0.0 % receiving Rapid PCR ( P < 0.001 ) .
RESULTS	Rapid PCR modestly reduced the median days to ART ( 3.0 vs 6.5 , P = 0.001 ) but did not influence outpatient follow-up for HIV-infected infants ( 78.1 % vs 82.4 % , P = 0.418 ) .
CONCLUSIONS	Rapid PCR , versus an optimized standard care , increased the proportion of hospitalized HIV-infected infants initiating ART and reduced ART exposure in molecular test-negative infants , without meaningfully impacting time to ART initiation or follow-up rates .

###24505318
BACKGROUND	A psychological disorder called ` Internet addiction ' has newly emerged along with a dramatic increase of worldwide Internet use .
BACKGROUND	However , few studies have used population-level samples nor taken into account contextual factors on Internet addiction .
RESULTS	We identified 57,857 middle and high school students ( 13-18 year olds ) from a Korean nationally representative survey , which was surveyed in 2009 .
RESULTS	To identify associated factors with addictive Internet use , two-level multilevel regression models were fitted with individual-level responses ( 1st level ) nested within schools ( 2nd level ) to estimate associations of individual and school characteristics simultaneously .
RESULTS	Gender differences of addictive Internet use were estimated with the regression model stratified by gender .
RESULTS	Significant associations were found between addictive Internet use and school grade , parental education , alcohol use , tobacco use , and substance use .
RESULTS	Female students in girls ' schools were more likely to use Internet addictively than those in coeducational schools .
RESULTS	Our results also revealed significant gender differences of addictive Internet use in its associated individual - and school-level factors .
CONCLUSIONS	Our results suggest that multilevel risk factors along with gender differences should be considered to protect adolescents from addictive Internet use .

###25527243
OBJECTIVE	Adherence to prescribed exercise is a challenge for cancer patients undergoing treatment .
OBJECTIVE	The changing pattern of exercise adherence over time can not be fully understood by an overall measure of adherence .
OBJECTIVE	This study was aimed to identify the trajectory of exercise adherence and its predictors for women with breast cancer during their chemotherapy .
METHODS	Participants were 78 women with breast cancer assigned to the exercise arm of a randomized control trial .
METHODS	Based on the weekly adherence rates in time and intensity , patients were classified as good ( > 100 % ) , acceptable ( 80-100 % ) , and poor ( < 80 % ) adherents .
METHODS	Data were analyzed using ordinal logistic hierarchical linear modeling .
RESULTS	The trajectories for both time and intensity adherence declined significantly .
RESULTS	The decline in exercise-time adherence was significantly slower in women who reported higher interest in exercise .
RESULTS	Women with higher perceived importance of exercise , early disease stage , and employed were more likely to be classified as good intensity adherents .
RESULTS	Poorer weekly adherence for both exercise time and intensity was associated with higher fatigue level for that week .
CONCLUSIONS	Adherence to exercise adherence in breast cancer patients declined as the dose of exercise prescription increased .
CONCLUSIONS	Factors influencing overall adherence and adherence trend were identified .

###24695352
OBJECTIVE	Efavirenz is widely prescribed for HIV-1 infection .
OBJECTIVE	Three polymorphisms in CYP2B6 define plasma efavirenz trough concentration strata that vary across an 10-fold range .
OBJECTIVE	We characterized associations between human genetic polymorphisms and virologic response among participants who received efavirenz-containing regimens in a prospective clinical trial .
METHODS	We genotyped 76 polymorphisms in CYP2B6 ( including those that define efavirenz concentration strata ) , CYP2A6 , CYP3A4 , CYP3A5 and ABCB1 and week 48 virologic responses in 360 Haitians who initiated efavirenz-containing regimens in protocol HT 001 .
METHODS	Associations were characterized by logistic regression analysis and Fisher 's exact test .
RESULTS	Proportions with HIV-1 RNA < 50 or < 200 copies/mL did not differ across 10 CYP2B6 metabolizer strata .
RESULTS	In analyses that combined strata into three metabolizer levels ( extensive , intermediate and slow ) , the respective proportions were 0.79 , 0.79 and 0.81 ( < 50 copies/mL cut-off ) and 0.84 , 0.86 and 0.87 ( < 200 copies/mL cut-off ) .
RESULTS	Genetic associations were not identified after controlling for baseline variables or with other polymorphisms after adjusting for multiple comparisons .
CONCLUSIONS	Virologic failures in HT 001 were not explained by genetic polymorphisms known to define the lowest plasma efavirenz concentration stratum .

###24850540
OBJECTIVE	the aim of this study was to compare the effects of a functional tasks exercise programme to a cognitive training programme in older adults with mild cognitive impairment .
METHODS	a single-blind randomised control trial with the intervention group compared with an active control group .
METHODS	out-patient clinic .
METHODS	older adults with mild cognitive impairment ( n = 83 ) aged 60 and older living in the community .
METHODS	participants were randomised to either a functional task exercise group ( n = 43 ) or an active cognitive training group ( n = 40 ) for 10 weeks .
METHODS	All outcome measures were undertaken at baseline , post-intervention and 6-month follow-up using Neurobehavioral Cognitive Status Examination , Trail Making Test , Chinese Version Verbal Learning Test , Category Verbal Learning Test , Lawton Instrumental Activities of Daily Living Scale and Problems in Everyday Living Test .
RESULTS	the functional task exercise group showed significant between-group differences in general cognitive functions , memory , executive function , functional status and everyday problem solving ability .
RESULTS	The improvements were sustained over time at 6-month follow-up .
CONCLUSIONS	a functional tasks exercise programme is feasible for improving cognitive functions and functional status of older adults with mild cognitive impairment .
CONCLUSIONS	This may serve as a cost-effective adjunct to the existing interventions for populations with mild cognitive impairment .
BACKGROUND	ACTRN12610001025022 .

###24677117
OBJECTIVE	The effect of proton pump inhibitors ( PPIs ) on the pharmacokinetics and pharmacodynamics of clopidogrel was assessed in two healthy volunteer crossover studies .
METHODS	Study 1 : subjects received clopidogrel alone ( 300-mg loading dose , then 75 mg/day for 28 days ) and two of three PPIs ( omeprazole 80 mg , esomeprazole 40 mg or lansoprazole 60 mg ) plus clopidogrel for 29 days in three treatment periods ( randomized treatment sequence assignment ) .
METHODS	Study 2 : subjects received clopidogrel alone ( 75 mg/day for 9 days ) and clopidogrel alone for 4 days followed by clopidogrel plus fixed-combination esomeprazole 20 mg/low-dose acetylsalicylic acid ( ASA ) 81 mg for 5 days in two treatment periods ( randomized treatment sequence assignment ) .
METHODS	Pharmacokinetic effects were estimated by measuring active metabolite of clopidogrel , and pharmacodynamic effects by inhibition of adenosine diphosphate ( ADP ) - induced platelet aggregation .
RESULTS	There was a relative decrease of up to 50 % in exposure to the active metabolite of clopidogrel with the different PPIs ( study 1 ) , and close to 40 % with esomeprazole/low-dose ASA ( study 2 ) , compared with clopidogrel alone .
RESULTS	There was an absolute decrease of up to 17 % in inhibition of ADP-induced platelet aggregation with co-administration of different PPIs , compared with clopidogrel alone ; however , no differences in platelet inhibition were observed during co-administration with the esomeprazole/low-dose ASA fixed-dose combination .
CONCLUSIONS	Omeprazole , esomeprazole and lansoprazole decreased systemic exposure to the active metabolite of clopidogrel in healthy volunteers , leading to modest decreases in its antiplatelet effect .
CONCLUSIONS	However , no apparent differences in platelet inhibition were observed when esomeprazole was co-administered with low-dose ASA as a fixed-dose combination .

###24501015
BACKGROUND	Despite their high rates of depression , homebound older adults have limited access to evidence-based psychotherapy .
BACKGROUND	The purpose of this paper was to report both depression and disability outcomes of telehealth problem-solving therapy ( tele-PST via Skype video call ) for low-income homebound older adults over 6 months postintervention .
METHODS	A 3-arm randomized controlled trial compared the efficacy of tele-PST to in-person PST and telephone care calls with 158 homebound individuals who were aged 50 + and scored 15 + on the 24-item Hamilton Rating Scale for Depression ( HAMD ) .
METHODS	Treatment effects on depression severity ( HAMD score ) and disability ( score on the WHO Disability Assessment Schedule [ WHODAS ] ) were analyzed using mixed-effects regression with random intercept models .
METHODS	Possible reciprocal relationships between depression and disability were examined with a parallel-process latent growth curve model .
RESULTS	Both tele-PST and in-person PST were efficacious treatments for low-income homebound older adults ; however the effects of tele-PST on both depression and disability outcomes were sustained significantly longer than those of in-person PST .
RESULTS	Effect sizes ( dGMA-raw ) for HAMD score changes at 36 weeks were 0.68 for tele-PST and 0.20 for in-person PST .
RESULTS	Effect sizes for WHODAS score changes at 36 weeks were 0.47 for tele-PST and 0.25 for in-person PST .
RESULTS	The results also supported reciprocal and indirect effects between depression and disability outcomes .
CONCLUSIONS	The efficacy and potential low cost of tele-delivered psychotherapy show its potential for easy replication and sustainability to reach a large number of underserved older adults and improve their access to mental health services .

###24766975
BACKGROUND	Steroids may improve outcomes in high-risk patients undergoing cardiac surgery with the use of cardiopulmonary bypass ( CBP ) .
BACKGROUND	There is a need \ for a large randomized controlled trial to clarify the effect of steroids in such patients .
METHODS	We plan to randomize 7,500 patients with elevated European System for Cardiac Operative Risk Evaluation who are undergoing cardiac surgery with the use of CBP to methylprednisolone or placebo .
METHODS	The first coprimary outcome is 30-day all-cause mortality , and the most second coprimary outcome is a composite of death , MI , stroke , renal failure , or respiratory failure within 30 days .
METHODS	Other outcomes include a composite of MI or mortality at 30 days , new onset atrial fibrillation , bleeding and transfusion requirements , length of intensive care unit stay and hospital stay , infection , stroke , wound complications , gastrointestinal complications , delirium , postoperative insulin use and peak blood glucose , and all-cause mortality at 6 months .
RESULTS	As of October 22 , 2013 , 7,034 patients have been recruited into SIRS in 82 centers from 18 countries .
RESULTS	Patient 's mean age is 67.3 years , and 60.4 % are male .
RESULTS	The average European System for Cardiac Operative Risk Evaluation is 7.0 with 22.1 % having an isolated coronary artery bypass graft procedure , and 66.1 % having a valve procedure .
CONCLUSIONS	SIRS will lead to a better understanding of the safety and efficacy of prophylactic steroids for cardiac surgery requiring CBP .

###25378426
OBJECTIVE	Although multiple studies have suggested that repetitive transcranial magnetic stimulation ( rTMS ) may facilitate recovery after stroke , the efficacy of synchronous speech therapy integrated with an rTMS protocol has yet to be determined .
OBJECTIVE	We investigated language responses to this strategy and determined the longevity of the resulting therapeutic outcomes .
METHODS	Forty-five patients with stroke who presented with nonfluent aphasia were randomly assigned to the TMSsyn group and underwent synchronous picture-naming training together with contralesional 1 Hz-rTMS for 10 daily sessions .
METHODS	The TMSsub group underwent subsequent picture-naming activity after the primed 1 Hz-rTMS , and the TMSsham group received concurrent naming task along with the sham 1 Hz-rTMS .
METHODS	The Concise Chinese Aphasia test and the picture-naming test were performed before , immediately , and after 3 months of the intervention .
RESULTS	TMSsyn showed significantly superior results in Concise Chinese Aphasia test score ( P < 0.001 ) , expression and description subtests ( P < 0.001 ) , and action ( P = 0.02 ) and object naming activity ( P = 0.008 ) ; the superior results lasted for 3 months ( P = 0.005 ) , in comparison with the TMSsub and TMSsham groups .
CONCLUSIONS	We established a real-time model that involved implementing verbal tasks together with the rTMS protocol .
CONCLUSIONS	Our results confirmed that the strategy yielded favorable outcomes that were of considerable longevity .
CONCLUSIONS	The results also indicated that the rTMS protocol and language training can be combined to achieve outcomes superior to those obtained when used separately .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT02120508 .

###24263274
OBJECTIVE	Traditional training of electroconvulsive therapy ( ECT ) consists of a combination of didactic and hands-on demonstrations using ECT equipment .
OBJECTIVE	Our goal was to explore the potential of a high-fidelity patient simulator ( HPS ) to train these skills .
OBJECTIVE	To our knowledge , this is the first time an HPS has been used for skills training in psychiatry .
METHODS	Nineteen psychiatry residents participated in this randomized controlled trial to compare traditional training ( n = 9 ) versus training using an HPS ( n = 10 ) .
METHODS	Two blinded raters assessed performance using a newly developed checklist and global rating scale for this task ( ECT-OSATS ) ( Objective Structured Assessment of Technical Skills ) .
METHODS	Residents also completed a pretest-posttest knowledge test and confidence survey .
RESULTS	Residents in the HPS group performed significantly better in terms of ECT-OSATS when compared with the control group ( P < 0.001 ) .
RESULTS	All 10 of the HPS group received a `` pass '' rating following training , whereas only 1 of the 9 control group received a `` pass '' rating .
RESULTS	There were no significant group differences in posttest confidence ( P = 0.21 ) or total knowledge gain scores from pretest to posttest ( P = 0.36 ) .
CONCLUSIONS	The level of clinical skill acquired by trainees in psychiatry for performing ECT is significantly superior using HPS - based training , in contrast to the domains of knowledge and confidence , which appear to be equally imparted using either training modality .
CONCLUSIONS	The acquisition of skills in administering ECT seems to be an independent variable in relation to a clinician 's level of knowledge and confidence in performing ECT .

###25158896
OBJECTIVE	To compare the advantages of prolotherapy in the treatment of first carpometacarpal osteoarthritis ( OA ) with those of corticosteroid local injection in the short and long term .
METHODS	We performed a randomized controlled trial from March 2010 to March 2011 in an outpatient clinic at a university hospital .
METHODS	Sixty participants ( 60 hands ) with OA of the first carpometacarpal joint were assigned equally to two groups .
METHODS	For the corticosteroid group , after 2 monthly saline placebo injections , a single dose of 40 mg methylprednisolone acetate ( 0.5 ml ) mixed with 0.5 ml of 2 % lidocaine was injected .
METHODS	For the dextrose ( DX ) group , 0.5 ml of 20 % DX was mixed with 0.5 ml of 2 % lidocaine and the injection was repeated monthly for 3 months .
METHODS	Pain intensity , hand function and the strength of lateral pinch grip were measured at the baseline and at 1 , 2 , and 6 months after the treatment .
RESULTS	Mean age ( STD ) was 63.6 ( 9.7 ) years , and mean ( STD ) visual analog scale ( VAS ) was 6 ( 2 ) .
RESULTS	The two groups were comparable at 2 months , but significantly different at 1 month , with better results for corticosteroid , and at 6 months with apparently more favorable outcome for DX [ mean difference ( 95 % CI ) in VAS = 1.1 ( 0.2 , 2.0 ) , p = 0.02 ] .
RESULTS	After 6 months of treatment , both DX and corticosteroid injection increased functional level , but DX seemed to be more effective [ mean difference ( 95 % CI ) in total function score = 1.0 ( 0.2 , 1.8 ) , p = 0.01 ] .
CONCLUSIONS	For the long term , DX seems to be more advantageous , while the two treatments were comparable in the short term .
CONCLUSIONS	Because of the satisfactory pain relief and restoring of function , we would prefer DX prolotherapy for the treatment of patients with OA .
METHODS	Therapeutic studies -- investigating the results of treatment ; level I.

###24658627
OBJECTIVE	QT assessment of oncology drugs is generally challenging because they are genotoxic and , of necessity , they require multisite evaluation in cancer patients .
OBJECTIVE	Lenvatinib is not genotoxic , therefore , this thorough QT ( TQT ) study with lenvatinib , a multityrosine kinase inhibitor , was undertaken utilizing healthy volunteers and concentration effect modeling to project the TQT effect at high plasma levels .
METHODS	Fifty-two healthy subjects randomly received single doses of lenvatinib 32 mg , placebo , or moxifloxacin 400 mg in a three-way crossover study .
METHODS	Serial electrocardiograms were recorded , and the effect on placebo corrected change-from-baseline QTcF ( QTcF ) was evaluated .
METHODS	The relationship between lenvatinib plasma concentrations and QTcF was analyzed with linear mixed effects modeling .
RESULTS	L envatinib mildly lowered the heart rate by 58 bpm during the first 12 h after dosing .
RESULTS	QTcF was shortened with a peak effect of 5.72 ms ( 90 % confidence interval ( 90 % CI ) 7.76 to 3.69 ms ) at 6 h postdosing.The upper bound of mean QTcF did not exceed 2 ms at any time point postdosing .
RESULTS	A concentration-dependent effect of lenvatinib on QTcF was identified with an estimated population intercept of 2.96 ms ( 90 % CI 4.49 to1 .43 ms ; P = 0.0016 ) and a negative slope of 0.0045 ( 90 % CI 4.49 to 1.43 ) ms per ng/mL , respectively .
RESULTS	The safety profile after a single dose of lenvatinib was acceptable , with adverse events ( AEs ) of mild-to-moderate severity and no serious AEs .
CONCLUSIONS	L envatinib had no clinically relevant effect on the QTc interval .
CONCLUSIONS	Concentration-effect modeling supports the lack of QTc prolongation at high plasma concentrations .

###24423366
BACKGROUND	Low 25-hydroxyvitamin D levels are common in patients with primary hyperparathyroidism ( PHPT ) and associated with higher PTH levels and hungry bone syndrome after parathyroidectomy ( PTX ) .
BACKGROUND	However , concerns have been raised about the safety of vitamin D supplementation in PHPT .
OBJECTIVE	We aimed to assess safety and effects on calcium homeostasis and bone metabolism of supplementation with high doses of vitamin D in PHPT patients .
METHODS	This was an investigator-initiated double-blind , randomized , placebo-controlled , parallel-group trial from a single center .
METHODS	Forty-six PHPT patients were recruited , with a mean age of 58 ( range 29-77 ) years , and 35 ( 76 % ) were women .
METHODS	Intervention included daily supplementation with 70 g ( 2800 IU ) cholecalciferol or identical placebo for 52 weeks .
METHODS	Treatment was administered 26 weeks before PTX and continued for 26 weeks after PTX .
METHODS	PTH , calcium homeostasis , and bone metabolism were evaluated .
RESULTS	Preoperatively , 25-hydroxyvitamin D increased from 50 to 94 nmol/L in the treatment group and decreased from 57 to 52 nmol/L in the placebo group ( P < .001 ) .
RESULTS	Compared with placebo , vitamin D decreased PTH significantly by 17 % before PTX ( P = .01 ) , increased lumbar spine bone mineral density by 2.5 % ( P = .01 ) , and decreased C-terminal - CrossLaps by 22 % ( P < .005 ) .
RESULTS	The trabecular bone score did not change in response to treatment , but improved after PTX .
RESULTS	Postoperatively , PTH remained lower in the cholecalciferol group compared with the placebo group ( P = .04 ) .
RESULTS	Plasma creatinine and plasma and urinary calcium did not differ between groups .
CONCLUSIONS	Daily supplementation with a high vitamin D dose safely improves vitamin D status and decreases PTH in PHPT patients .
CONCLUSIONS	The vitamin D treatment is accompanied by reduced bone resorption and improved bone mineral density before operation .

###24951180
BACKGROUND	In line with a rapidly ageing global population , the rise in the frequency of falls will lead to increased healthcare and social care costs .
BACKGROUND	This study will be one of the few randomized controlled trials evaluating a multifaceted falls intervention in a low-middle income , culturally-diverse older Asian community .
BACKGROUND	The primary objective of our paper is to evaluate whether individually tailored multifactorial interventions will successfully reduce the number of falls among older adults .
METHODS	Three hundred community-dwelling older Malaysian adults with a history of ( i ) two or more falls , or ( ii ) one injurious fall in the past 12 months will be recruited .
METHODS	Baseline assessment will include cardiovascular , frailty , fracture risk , psychological factors , gait and balance , activities of daily living and visual assessments .
METHODS	Fallers will be randomized into 2 groups : to receive tailored multifactorial interventions ( intervention group ) ; or given lifestyle advice with continued conventional care ( control group ) .
METHODS	Multifactorial interventions will target 6 specific risk factors .
METHODS	All participants will be re-assessed after 12 months .
METHODS	The primary outcome measure will be fall recurrence , measured with monthly falls diaries .
METHODS	Secondary outcomes include falls risk factors ; and psychological measures including fear of falling , and quality of life .
CONCLUSIONS	Previous studies evaluating multifactorial interventions in falls have reported variable outcomes .
CONCLUSIONS	Given likely cultural , personal , lifestyle and health service differences in Asian countries , it is vital that individually-tailored multifaceted interventions are evaluated in an Asian population to determine applicability of these interventions in our setting .
CONCLUSIONS	If successful , these approaches have the potential for widespread application in geriatric healthcare services , will reduce the projected escalation of falls and fall-related injuries , and improve the quality of life of our older community .
BACKGROUND	ISRCTN11674947 .

###24732784
OBJECTIVE	The purpose of the present study was to compare the effects of equal-volume resistance training ( RT ) performed once or twice a week on muscle mass and strength of the elbow flexors in untrained young men .
METHODS	Thirty men ( 23 3 years ) without previous resistance training experience were divided into two groups : Group 1 ( G1 ) trained each muscle group only once a week and group 2 ( G2 ) trained each muscle twice a week during 10 weeks .
METHODS	Baseline and 10 weeks post-test elbow flexors muscle thickness ( MT ) were measured using a B-Mode ultrasound .
METHODS	Peak torque ( PT ) was assessed by an isokinetic dynamometer before and after the training program .
RESULTS	Elbow flexors MT increased significantly ( P < 0.05 ) from 31.70 3.31 to 33.43 3.46 mm in G1 , and from 32.78 4.03 to 35.09 3.55 mm in G2 .
RESULTS	Elbow flexors PT also increased ( P < 0.05 ) from 50.77 9.26 to 54.15 10.79 N.m in G1 , and from 48.99 11.52 to 55.29 10.24 N.m in G2 .
RESULTS	The results of ANOVA did not reveal group by time interactions for any variable , indicating no difference between groups for the changes in MT or PT .
CONCLUSIONS	The results from the present study suggest that untrained men experience similar gains in muscle mass and strength with equal volume RT performed one or two days per week .

###24655695
BACKGROUND	The introduction of new medical devices may be accompanied by a learning curve .
METHODS	To evaluate the impact of the device learning curve on the outcomes of PROTECT II trial , comparing Impella 2.5 versus the intra-aortic balloon pump ( IABP ) during high-risk percutaneous coronary intervention , we report on a prespecified analysis , excluding the first Impella 2.5 and IABP patients at each site .
RESULTS	A total of 448 patients were enrolled at 74 sites .
RESULTS	Among these , 58 patients were the first to receive Impella 2.5 at their site , 62 were the first to receive IABP .
RESULTS	A trend toward higher major adverse events ( MAEs ) at 30 days was observed for the subgroup of first versus remaining Impella 2.5 patients : 44.8 % versus 31.7 % , P = .072 .
RESULTS	MAE rates for the first and remaining IABP patients were similar at 30 days .
RESULTS	After exclusion of the first patient in each group , MAE rates for Impella 2.5 and IABP were 31.7 % versus 40.0 % ( P = .119 ) at 30 days and 38.0 % versus 50.0 % ( P = .029 ) at 90 days .
CONCLUSIONS	Significantly lower 90-day MAE rates were observed with the use of Impella 2.5 compared to the use of IABP after excluding the first patient per group at each site .
CONCLUSIONS	This prespecified analysis suggests a learning curve associated with initial introduction of the Impella 2.5 .
CONCLUSIONS	Clinical trials should better address the training aspect of new devices , especially when compared with more established devices .

###24231197
OBJECTIVE	One-lung ventilation ( OLV ) is accomplished with a double-lumen tube ( DLT ) or a bronchial blocker ( BB ) .
OBJECTIVE	The authors compared the effectiveness of lung collapse using DLT , BB , and BB with the disconnection technique .
METHODS	Prospective , randomized , blind trial .
METHODS	A university hospital .
METHODS	Fifty-two patients undergoing elective pneumothorax surgery .
METHODS	Patients were assigned randomly to 1 of 3 groups : The DLT group ( group 1 ) , the BB group ( group 2 ) , and the BB with the disconnection technique group ( group 3 ) .
METHODS	The authors modified the disconnection technique in group 3 as follows : ( 1 ) turned off the ventilator and opened the adjustable pressure-limiting valve , allowing both lungs to collapse and ( 2 ) after loss of the CO2 trace on the capnograph , inflated the blocker cuff and turned on the ventilator , allowing only dependent-lung ventilation .
RESULTS	Five and ten minutes after OLV , the degree of lung collapse was assessed by the surgeon , who was blinded to the isolation technique .
RESULTS	The quality of lung collapse at 5 and 10 minutes was significantly better in groups 1 and 3 than in group 2 .
RESULTS	No significant differences were observed for the degree of lung collapse at any time point between groups 1 and 3 .
RESULTS	The average time for loss of the CO2 trace on the capnograph was 32.37.0 seconds in group 3 .
CONCLUSIONS	A BB with spontaneous collapse took longer to deflate and did not provide equivalent surgical exposure to the DLT .
CONCLUSIONS	The disconnection technique could be helpful to accelerate lung collapse with a BB .

###24766062
OBJECTIVE	To compare levels of diabetes distress in people with Type 2 diabetes treated in primary and secondary care and to examine demographic and clinical correlates that may explain potential differences in levels of distress between care settings .
METHODS	People with Type 2 diabetes from 24 primary care practices ( n = 774 ) and three secondary care clinics ( n = 526 ) completed the Problem Areas In Diabetes questionnaire .
METHODS	Data on HbA1c levels and diabetes complications were derived from medical charts .
METHODS	Hierarchical ordinal regression analysis was used to investigate which correlates could explain the potential differences in level of diabetes distress between care settings .
RESULTS	Diabetes distress levels and the prevalence of elevated diabetes distress were considerably lower in the participants treated in primary care ( mean ( SD ) total diabetes distress score 8 ( 11 ) ; 4 % of participants with a Problem Areas In Diabetes score 40 ) than in secondary care ( mean ( SD ) total diabetes distress score 23 ( 21 ) ; 19 % of participants with a Problem Areas In Diabetes score 40 , P < 0.001 ) .
RESULTS	In addition to care setting , the following variables were also independently related to diabetes distress : younger age , ethnic minority status , using insulin , having a higher HbA1c level , having a higher BMI and the presence of neuropathy .
RESULTS	Other diabetes complications were not independently associated with diabetes distress .
CONCLUSIONS	In primary care , lower levels of diabetes distress were reported than in secondary care .
CONCLUSIONS	The difference in diabetes distress between care settings can be largely , but not fully , explained by specific demographic and clinical characteristics .
CONCLUSIONS	These results need to be interpreted with caution as they are based on two separate studies , but do call into question the need to screen for diabetes distress in people with Type 2 diabetes in primary care .

###24703391
BACKGROUND	This randomized , double-blind , parallel-group clinical trial aims to assess the equivalence of intra-articular polynucleotides compared to standard hyaluronic acid ( HA ) viscosupplementation in the treatment of knee osteoarthritis ( OA ) .
METHODS	75 patients affected by knee OA were assessed for eligibility and 72 were enrolled and randomized to receive either intra-articular polynucleotides ( Condrotide-36 patients ) or hyaluronic acid ( Hyalubrix-36 patients ) at the Orthopedic Institute `` Gaetano Pini '' ( Milan ) .
METHODS	All patients underwent three intra-articular injections of Condrotide or Hyalubrix with an interval of 1week .
METHODS	Participants , care givers , and investigators responsible for outcome assessment were all blinded to group assignment .
METHODS	Primary outcome measurements ( KOOS and pain level ( 1 ) at rest , ( 2 ) at weight-bearing and ( 3 ) during physical activity ) were evaluated at baseline ( T0 ) and after one ( T1 ) , two ( T2 ) , six ( T6 ) , ten ( T10 ) , and 26 ( T26 ) weeks .
METHODS	Secondary measurements included the determination of COMP serum levels at T0 , T6 and T26 .
RESULTS	The reduction of pain and the increase of KOOS values from baseline were statistically significant for both treatments ; nevertheless , for parameter KOOS `` symptoms '' the treatment with Condrotide showed significant results already after twoweeks ( at T2 p = 0.003 ) while the results obtained with Hyalubrix became significant only after 18 weeks ( at T18 p = 0.01 ) .
RESULTS	No significant adverse events were reported .
CONCLUSIONS	Condrotide is as effective as Hyalubrix in reducing knee OA symptoms but showed an earlier response on pain reduction and can therefore be considered a valid alternative to the use of HA in the treatment of OA , avoiding the adverse events of NSAIDs and of intra-articular corticosteroids .

###24798668
OBJECTIVE	To develop a multivariable prognostic model for the risk of preterm delivery in women with multiple pregnancy that includes cervical length measurement at 16 to 21 weeks ' gestation and other variables .
METHODS	We used data from a previous randomized trial .
METHODS	We assessed the association between maternal and pregnancy characteristics including cervical length measurement at 16 to 21 weeks ' gestation and time to delivery using multivariable Cox regression modelling .
METHODS	Performance of the final model was assessed for the outcomes of preterm and very preterm delivery using calibration and discrimination measures .
RESULTS	We studied 507 women , of whom 270 ( 53 % ) delivered < 37 weeks ( preterm ) and 66 ( 13 % ) < 32 weeks ( very preterm ) .
RESULTS	Women with cervical length < 30 mm delivered more often preterm ( hazard ratio 1.9 ; 95 % CI 0.7 to 4.8 ) .
RESULTS	Other independently contributing predictors were previous preterm delivery , monochorionicity , smoking , educational level , and triplet pregnancy .
RESULTS	Prediction models for preterm and very preterm delivery had a c-index of 0.68 ( 95 % CI 0.63 to 0.72 ) and 0.68 ( 95 % CI 0.62 to 0.75 ) , respectively , and showed good calibration .
CONCLUSIONS	In women with a multiple pregnancy , the risk of preterm delivery can be assessed with a multivariable model incorporating cervical length and other predictors .

###24989702
OBJECTIVE	Dietary sodium loading has been shown to adversely impact endothelial function independently of blood pressure ( BP ) .
OBJECTIVE	However , it is unknown whether dietary sodium loading impacts endothelial function differently in men as compared to women .
OBJECTIVE	The aim of this study was to test the hypothesis that endothelial-dependent dilation ( EDD ) would be lower in men as compared to women in response to a high sodium diet .
RESULTS	Thirty subjects ( 14F , 312y ; 16M , 292y ) underwent a randomized , crossover , controlled diet study consisting of 7 days of low sodium ( LS ; 20 mmol/day ) and 7 days of high sodium ( HS ; 300-350 mmol/day ) .
RESULTS	Salt-resistance was determined by a change in 24-hr mean arterial pressure ( MAP ) 5 mm Hg between HS and LS as assessed on day 7 of each diet .
RESULTS	Blood and 24-hr urine were also collected and EDD was assessed by brachial artery flow-mediated dilation ( FMD ) .
RESULTS	By design , MAP was not different between LS and HS conditions and urinary sodium excretion increased on HS diet ( P < 0.01 ) .
RESULTS	FMD did not differ between men and women on the LS diet ( 10.2 0.65 vs. 10.7 0.83 ; P > 0.05 ) and declined in both men and women on HS ( P < 0.001 ) .
RESULTS	However , FMD was lower in men as compared to women on HS ( 5.7 0.5 vs. 8.6 0.86 ; P < 0.01 ) .
CONCLUSIONS	HS reduced FMD in both men and women .
CONCLUSIONS	In response to an HS diet , FMD was lower in men compared to women suggesting a greater sensitivity of the vasculature to high sodium in men .

###24775575
BACKGROUND	We assessed the efficacy of onabotulinumtoxinA ( BOTOX , Allergan Inc. , Irvine , CA , USA ) in patients with refractory overactive bladder ( OAB ) after treatment for benign prostatic hyperplasia ( BPH ) .
METHODS	This was a two-center , randomized , double-blinded pilot study conducted in patients with OAB secondary to bladder outlet obstruction ( BOO ) , refractory to anticholinergic medication and persistent for greater than 3 months after surgical intervention to relieve obstruction , with an International Prostate Symptom Score ( IPSS ) > 12 .
METHODS	Patients were randomized in 1:1 fashion to either 200 units of onabotulinumtoxinA versus placebo .
METHODS	Fifteen patients received onabotulinumtoxinA versus 13 who received placebo .
METHODS	Follow up was performed at 1 week and then 1 , 3 , 6 , and 9 months .
METHODS	The primary endpoint was reduction in the frequency of micturition per 24 hours by 3-day voiding diary .
METHODS	Secondary endpoints were maximum flow rate ( Qmax ) , post-void residual ( PVR ) , and IPSS scores .
RESULTS	Patients receiving onabotulinumtoxinA demonstrated significantly improved quality of life scores at 180 and 270 days after treatment ( p = 0.02 and 0.03 , respectively ) as well as significantly lower International Consultation on Incontinence Questionnaire ( ICIQ ) scores ( p < 0.05 ) .
RESULTS	Baseline urinary frequency was 10.5 versus 11.0 voids/day ( p = 0.47 ) .
RESULTS	Frequency episodes improved from 11 episodes per day to 8 episodes per day in the treatment arm .
RESULTS	The placebo arm did not have a decrease in frequency episodes .
RESULTS	This response was durable up to 90 days , although this was not statistically significant .
RESULTS	IPSS , PVR , and urgency were unchanged postoperatively in both groups .
CONCLUSIONS	OnabotulinumtoxinA was safe in patients with refractory irritative lower urinary tracts symptoms after surgical treatment of BPH .
CONCLUSIONS	There were improvements in daily frequency , although the results were not statistically significant .
CONCLUSIONS	Larger trials are needed to help characterize the utility of onabotulinumtoxinA in the treatment of OAB secondary to BPH .

###25216597
OBJECTIVE	The aim of the study was to assess the hemodynamic and metabolic actions of estrogen plus progestin therapy ( EPT ) in hypertensive , postmenopausal women treated with perindopril ( ACEI ) or hydrochlorothiazide ( HCTZ ) .
OBJECTIVE	A group of normotensive postmenopausal women was also studied .
METHODS	100 hypertensive and 40 normotensive postmenopausal women were recruited for the study .
METHODS	The hypertensive females were randomly assigned to receive ACEI or HCTZ for 12months .
METHODS	The patients of the ACEI group and the patients of the HCTZ group , as well as normotensives , were further subdivided into two subgroups each .
METHODS	One subgroup received estrogen plus progestin therapy ( EPT + ) , the other subgroup received no hormone replacement ( EPT - ) .
METHODS	Combined hormone replacement with transdermal patches releasing 17-estradiol and norethisterone was used .
METHODS	Office and 24-hour ambulatory blood pressure was measured at baseline and during follow-up .
METHODS	Renal plasma flow ( RPF ) was measured using the clearance of [ 125I ] - iodohippuran .
METHODS	Pulse wave velocity ( PWV ) was determined with an automatic device .
RESULTS	In normotensive postmenopausal women , transdermal estrogen plus progestin therapy increases RPF and insulin sensitivity , decreases PWV , decreases total and LDL cholesterol , and decreases uric acid serum levels .
RESULTS	Perindopril ( 4mg/day ) and hydrochlorothiazide ( 25mg/day ) were equally effective in reducing blood pressure in postmenopausal , hypertensive subjects .
RESULTS	In these females , perindopril increased RPF and decreased PWV and plasma insulin levels .
RESULTS	These effects of the ACEI were not altered by estrogen plus progestin therapy .
RESULTS	Hydrochlorothiazide decreased RPF and increased plasma insulin and uric acid concentrations in hypertensive subjects whom were not receiving estrogen plus progestin therapy .
CONCLUSIONS	The unfavorable metabolic and hemodynamic actions of the diuretic were counteracted by estrogen plus progestin therapy .
CONCLUSIONS	Concomitant estrogen plus progestin therapy may be a method to avoid unfavorable hemodynamic and metabolic effects of thiazide diuretics in hypertensive , postmenopausal women .

###24712192
BACKGROUND	Distal radius fractures in young , working-age patients are frequent and are associated with potential disability in case of inappropriate treatment .
BACKGROUND	Our hypothesis is that there is no difference between patients treated with a volar plate and those treated with closed reduction and external fixation .
METHODS	We studied 69 patients with complex distal radius fractures .
METHODS	They were prospectively and randomly assigned to treatment with a volar plate or an external fixator : they were followed-up and assessed at one year using two scales , the Visual Analog Scale ( VAS ) and the McDermid et al. .
METHODS	Functionality Scale .
RESULTS	Both groups showed good results at one year .
RESULTS	Measurements in the pain Visual Analog Scale and disability measured with the McDermid et al. scale were not statistically significant .
RESULTS	Higher scores mean greater disability .
RESULTS	Scores above 20 were considered as failures .
RESULTS	We found 2 cases with complications in the F group ; one with material dislodgement and one with malunion , without significant differences .
CONCLUSIONS	Both treatments show good results in the medium-term ; no differences were found between both groups regarding pain and residual disability .
CONCLUSIONS	Complications were few and they were addressed conservatively ; they were less frequent with open reduction and internal fixation .
CONCLUSIONS	When ranges of motion and the complication rate were compared , the volar plate showed a statistically significant difference in a decreased complication risk .

###24887209
OBJECTIVE	To determine whether Asian and white subjects differ in clinical signs or subjective symptoms in response to the use of different biguanide-preserved contact lens care solutions .
METHODS	Forty-two subjects ( 15 Asian and 27 white ) wearing lotrafilcon B silicone hydrogel contact lenses used a preservative-free lens care solution bilaterally for 2 weeks , then used two biguanide-preserved solutions ( solution 1 : ReNu MPS ; solution 2 : AQuify MPS ) contralaterally in randomly assigned eyes for 4 weeks .
METHODS	Comprehensive ocular surface examinations were performed and symptomatology questionnaires were administered every 2 weeks .
METHODS	Investigators were masked as to solution assignment during examinations , whereas subjects were not to avoid potential difficulties in compliance with the protocol .
RESULTS	With solution 1 , most Asian and white subjects had grade 2 or greater corneal staining after 2 weeks ( 67 % and 59 % , respectively ) and 4 weeks ( 60 % and 67 % , respectively ) .
RESULTS	With solution 2 , grade 2 or greater corneal staining occurred in 40 % of Asians after 2 weeks and in 13 % after 4 weeks , but in only 4 % of whites after 2 weeks and 0 % after 4 weeks .
RESULTS	Whites reported significantly better average comfort ( P = 0.046 ) and less dryness ( P < 0.001 ) than did Asians .
CONCLUSIONS	Asians and whites differ in both ocular response to the use of contact lens care solutions and in reporting subjective symptoms .
CONCLUSIONS	Racial and ethnic differences should be considered when evaluating and treating contact lens patients in a clinical setting .

###24997747
OBJECTIVE	The purpose of this study was to evaluate the efficacy of periarticular multimodal drug injection after medial opening-wedge high tibial osteotomy regarding the postoperative pain level .
METHODS	From January 2011 to January 2012 , 70 patients underwent medial opening-wedge high tibial osteotomy .
METHODS	Thirty-five patients were randomly assigned to receive no injection ( group I ) , and 35 patients were assigned to receive periarticular multimodal drug injection ( group II ) .
METHODS	These 2 groups were compared regarding the postoperative pain level , frequency of additional nonsteroidal anti-inflammatory drug injections , total amount of patient-controlled analgesia , and number of times that patients pushed the patient-controlled analgesia button at each time interval .
METHODS	Statistical results were based on multivariate analysis of variance and repeated-measures analyses .
RESULTS	Multivariate analysis of variance of mean visual analog scale ( VAS ) scores over the 2-week postoperative period showed statistical significance ( P < .001 ) .
RESULTS	Repeated-measures analysis yielded a statistically significant difference ( P = .001 ) for the time-by-treatment interaction , showing a clear periarticular multimodal drug injection benefit over time based on VAS scores .
RESULTS	In addition , the mean number of times that patients pushed the patient-controlled analgesia button differed significantly between groups over time ( P = .01 ) .
RESULTS	The VAS scores , frequency of additional nonsteroidal anti-inflammatory drug injections , mean number of times that patients pushed the patient-controlled analgesia button , and mean total amount of fentanyl consumption differed significantly within each group over time ( P < .001 for all variables ) .
RESULTS	However , the frequency of additional nonsteroidal anti-inflammatory drug injections and mean total amount of fentanyl consumption did not differ significantly between groups over time ( P = .822 , P = .529 , and P = .282 ) .
RESULTS	Opioid - and injection-related complications were not found .
CONCLUSIONS	This prospective randomized study shows that intraoperative periarticular multimodal drug injections in patients undergoing medial opening-wedge high tibial osteotomy for unicompartmental osteoarthritis of the knee could result in significant reductions in VAS scores at 2weeks postoperatively .
METHODS	Level I , high-quality randomized controlled trial with statistically significant differences .

###24701731
BACKGROUND	Desflurane is the least soluble and most expensive inhalation agent .
BACKGROUND	Hence , low flow technique is suitable for anesthesia with desflurane .
BACKGROUND	However , one of the disadvantages of low flow technique is the discrepancy among the end-tidal concentration , inspired concentration , and vaporizer setting .
OBJECTIVE	To measure the concentrations of desflurane at different sites of the anesthesia circuit by varying fresh gas flow ( FGF ) rates but fixing expired concentration .
METHODS	Thirty ASA PS I-II adult patients were enrolled in this crossover study .
METHODS	After induction of anesthesia and ten minutes of wash-in period , the flow meters of oxygen and air were then adjusted to maintain FiO2 at 0.3 with the random sequences of FGF rates at 0.5 , 1 and 2 L x min ( -1 ) .
METHODS	Desflurane vaporizer was adjusted to obtain 5 % end-tidal desflurane concentration ( FeDES ) throughout the study period .
METHODS	After FeDES reached the target and was stable for 20 minutes , inspired concentration ofdesflurane ( FiDES ) and delivered desflurane concentration at fresh gas outlet ( FdDES ) were measured .
METHODS	Lastly , the consumption of desflurane was calculated .
RESULTS	FdDES was higher than FiDES in every FGF rates .
RESULTS	FdDES at FGF 0.5 L x min ( -1 ) ( 6.13 + / - 0.12 ) was significantly higher than FdDES at 1 and 2 L x min ( -1 ) ( 5.68 + / - 0.08 , 5.54 + / - 0.07 , respectively ) , but not significantly different between FGF 1 and 2 L x min ( -1 ) .
RESULTS	FeDES/FdDES at FGF 0.5 , 1 and 2 L.min ( -1 ) were 0.82 + / - 0.014 , 0.88 + / - 0.012 and 0.87 + / - 0.011 , respectively .
RESULTS	There was no significant difference of FeDES/FdDES between FGF 1 and 2 L x min ( -1 ) , but there was significant difference between FGF 1 and 0.5 L x min ( -1 ) with the p-value < 0.001 .
RESULTS	The calculated liquid desflurane consumption per hour at FGF rate of 0.5 , 1 and 2 L x min ( -1 ) were 8.77 + / - 0.17 , 16.28 + / - 0.24 and 31.73 + / - 0.41 mL x hr ( -1 ) .
CONCLUSIONS	Using FGF 2 L x min ( -1 ) has no advantage over FGF 1 L x min ( -2 ) , because they both have the similar FdDES .
CONCLUSIONS	Regarding at FGF 0.5 and 1 L x min ( -1 ) , the delivered concentration has to be increased to obtain the desired expired concentration with more intense at FGF 0.5 L x min ( -1 ) because there are more discrepancies between FdDES and FeDES .

###24621680
BACKGROUND	Increased oxidative stress and inflammation has a role in the pathogenesis of chronic obstructive pulmonary disease ( COPD ) .
BACKGROUND	Drugs with antioxidant and anti-inflammatory properties , such as N-acetylcysteine , might provide a useful therapeutic approach for COPD .
BACKGROUND	We aimed to assess whether N-acetylcysteine could reduce the rate of exacerbations in patients with COPD .
METHODS	In our prospective , randomised , double-blind , placebo-controlled , parallel-group study , we enrolled patients aged 40-80 years with moderate-to-severe COPD ( post-bronchodilator forced expiratory volume in 1 s [ FEV1 ] / forced vital capacity < 07 and FEV1 of 30-70 % of predicted ) at 34 hospitals in China .
METHODS	We stratified patients according to use of inhaled corticosteroids ( regular use or not ) at baseline and randomly allocated them to receive N-acetylcysteine ( one 600 mg tablet , twice daily ) or matched placebo for 1 year .
METHODS	The primary endpoint was the annual exacerbation rate in patients who received at least one dose of study drug and had at least one assessment visit after randomisation .
METHODS	This study is registered with the Chinese Clinical Trials Registry , ChiCTR-TRC-09000460 .
RESULTS	Between June 25 , 2009 , and Dec 29 , 2010 , we screened 1297 patients , of whom 1006 were eligible for randomisation ( 504 to N-acetylcysteine and 502 to placebo ) .
RESULTS	After 1 year , we noted 497 acute exacerbations in 482 patients in the N-acetylcysteine group who received at least one dose and had at least one assessment visit ( 116 exacerbations per patient-year ) and 641 acute exacerbations in 482 patients in the placebo group ( 149 exacerbations per patient-year ; risk ratio 078 , 95 % CI 067-090 ; p = 00011 ) .
RESULTS	N-acetylcysteine was well tolerated : 146 ( 29 % ) of 495 patients who received at least one dose of N-acetylcysteine had adverse events ( 48 serious ) , as did 130 ( 26 % ) of 495 patients who received at least one dose of placebo ( 46 serious ) .
RESULTS	The most common serious adverse event was acute exacerbation of COPD , occurring in 32 ( 6 % ) of 495 patients in the N-acetylcysteine group and 36 ( 7 % ) of 495 patients in the placebo group .
CONCLUSIONS	Our findings show that in Chinese patients with moderate-to-severe COPD , long-term use of N-acetylcysteine 600 mg twice daily can prevent exacerbations , especially in disease of moderate severity .
CONCLUSIONS	Future studies are needed to explore efficacy in patients with mild COPD ( GOLD I ) .
BACKGROUND	Hainan Zambon Pharmaceutical .

###25406652
BACKGROUND	Optimal positioning of orthodontic mini-implants is essential for a successful treatment with skeletal anchorage .
BACKGROUND	This study aims to compare the accuracy of two-dimensional radiographs with a cone beam computed tomography ( CBCT ) for mini-implant placement .
METHODS	An ideal site for mini-implant placement at the buccal interradicular space between the second premolar and the first molar was determined for 40 sites ( in 13 patients aged 14 to 28 years ) by using CBCT data .
METHODS	The mini-implant placement procedure was then divided into two groups .
METHODS	In CBCT group , mini-implants were placed at the sites determined from CBCT data .
METHODS	In RVG group , mini-implants were placed with the help of two-dimensional digital radiographs and a custom made guide .
METHODS	Postplacement CBCT scans were obtained to determine the accuracy of the mini-implant placement .
METHODS	The results were statistically analyzed with a Mann-Whitney test .
RESULTS	A statistically significant difference ( p value = 0.02 ) was observed between the two groups for deviation from an ideal height of placement of the mini-implants .
RESULTS	Deviations in mesiodistal positioning and angular deviation showed a statistically non-significant difference .
RESULTS	Three out of twenty mini-implants in the RVG group showed root contact in the mandibular arch that may be attributed to the narrower interradicular space and reduced accessibility in the mandibular posterior region .
CONCLUSIONS	Although CBCT provides an accurate three-dimensional visualization of the interradicular space , the two-dimensional intraoral radiograph of the interradicular area provides sufficient information for mini-implant placement .
CONCLUSIONS	Considering the amount of radiation exposure and cost with the two techniques , it is recommended to use two-dimensional radiographs with a surgical guide for a routine mini-implant placement .

###25200587
BACKGROUND	The amount of epicardial adipose tissue ( EAT ) around the heart has been identified as an independent predictor of coronary artery disease ( CAD ) , potentially through local release of inflammatory cytokines .
BACKGROUND	Ethnic differences have been observed , but no studies have investigated this relationship in the Mexican population .
BACKGROUND	The objective of the present study was to evaluate whether a relationship exist between EAT thickness assessed via echocardiography with CAD and adiponectin levels in a Mexican population .
METHODS	We studied 153 consecutive patients who underwent coronary angiography and transthoracic echocardiography ( TTE ) .
METHODS	EAT thickness on the free wall of the right ventricle was measured at the end of systole from parasternal long and short axis views of three consecutive cardiac cycles .
METHODS	Coronary angiograms were analyzed for the presence , extent and severity of CAD .
METHODS	Serum adiponectin , lipids , glucose , C-reactive protein and fibrinogen were determined .
RESULTS	EAT thickness was greater in patients with CAD than in those without CAD from both parasternal long ( 5.39 1.75 mm vs 4.00 1.67 mm p < 0.0001 ) and short-axis views ( 5.23 1.67 vs 4.12 1.77 , p = 0.001 ) .
RESULTS	EAT thickness measured from parasternal long and short-axis showed a statistically significant positive correlation with age ( r = 0.354 , p < 0.001 ; r = 0.286 , p < 0.001 respectively ) , and waist circumference ( r = 0.189 , p = 0.019 ; r = 0.217 , p = 0.007 respectively ) .
RESULTS	A significant negative correlation between EAT thickness from the parasternal long axis with cholesterol-HDL was observed ( r = -0.163 , p = 0.045 ) .
RESULTS	No significant correlation was found between epicardial fat thickness and serum adiponectin or with the severity of CAD .
CONCLUSIONS	EAT thickness was greater in patients with CAD .
CONCLUSIONS	However , no correlation was observed with the severity of the disease or with serum adiponectin levels .
CONCLUSIONS	EAT thickness measured by echocardiography might provide additional information for risk assessment and prediction of CAD .

###24986565
OBJECTIVE	To compare the level of sedation , cardiorespiratory changes , and quality of recovery in cats receiving methadone plus either low dose tiletamine-zolazepam or acepromazine for premedication prior to general anaesthesia for neutering .
METHODS	Prospective , randomized , blinded clinical study .
METHODS	Twenty cats 0.54 0.12 years-old ( mean SD ) , weighing 3.17 0.65 kg ( 10 male and 10 female ) .
METHODS	Cats were allocated randomly to receive intramuscularly either 0.03 mg kg ( -1 ) acepromazine ( ACE ) or 3 mg kg ( -1 ) tiletamine-zolazepam ( TZ ) , both regimens combined with 0.2 mg kg ( -1 ) methadone for premedication .
METHODS	Sedation was assessed 25 minutes after premedication using a visual analogue scale ( VAS ) and a simple descriptive scale ( SDS ) .
METHODS	Anaesthesia was induced with alfaxalone and maintained with isoflurane .
METHODS	Physiological parameters were recorded at 1 , 3 and 5 minutes post-endotracheal intubation .
METHODS	Recovery from cessation of isoflurane was timed and quality assessed using a SDS and a VAS .
METHODS	Data was analysed with Mann-Whitney U-test , students t-test , anova or ordinal logistic regression as relevant .
METHODS	Significance was taken as p < 0.05 .
RESULTS	Sedation was more pronounced in TZ than ACE as indicated by higher VAS ( 67 21 versus 13 5 ) and SDS scores [ 4 ( 1-4 ) versus 1 ( 0-1 ) ] .
RESULTS	Following sedation , Heart ( HR ) and respiratory ( fR ) rates did not differ between groups .
RESULTS	After anaesthetic induction , at times 1 , 3 and 5 HR , systolic arterial pressure and end tidal carbon dioxide were significantly higher and fR was significantly lower in TZ than ACE .
RESULTS	Recovery quality was similar between groups .
RESULTS	In both groups , times to extubation , head lift and sternal recumbency were similar , but time ( minutes ) until standing was significantly longer in TZ ( 31 16 ) than ACE ( 18 11 ) .
CONCLUSIONS	Low dose tiletamine-zolazepam combined with methadone provided superior sedation to ACE .
CONCLUSIONS	Recovery quality was similar , although time to standing was longer .

###24907444
OBJECTIVE	We describe the safety and efficacy of the Altis ( ) Single Incision Sling System for the treatment of female stress urinary incontinence through 12months .
METHODS	In this study we collected a variety of safety and efficacy measures relevant to the assessment of urinary incontinence .
METHODS	The primary efficacy end point was improvement in 24-hour pad weight test .
METHODS	Other efficacy measures included the cough stress test , Urogenital Distress Inventory-Short Form , Incontinence Impact Questionnaire-Short Form , Patient Global Impression of Improvement and 3-day voiding diary .
METHODS	Safety was evaluated through assessment of device and procedure related adverse events .
RESULTS	Of 116 surgical attempts 113 subjects were implanted with the Altis sling .
RESULTS	Of these patients 103 had primary efficacy data at baseline and 6 months , and 101 had efficacy data at baseline and 12 months .
RESULTS	Consequently 88 ( 85.4 % ) subjects at 6 months and 91 ( 90.1 % ) at 12 months achieved a 50 % or greater reduction in pad weight .
RESULTS	The cough stress test was negative for 95 ( 92.2 % ) subjects at 6 months and 91 ( 90.1 % ) at 12 months .
RESULTS	A decrease in median leaks per day was observed at 6 months and improvements in all patient reported measures were observed through 12 months .
RESULTS	A majority of subjects reported feeling much better or very much better at 6 and 12 months , respectively .
RESULTS	There were no reports of mesh erosion or migration and no unanticipated adverse events through 12 months .
CONCLUSIONS	The Altis sling appears to be safe and efficacious , and performs asintended in the treatment of stress urinary incontinence through 12 months .

###25775024
BACKGROUND	Transformation of B-cell chronic lymphocytic leukaemia ( B-CLL ) to diffuse large B cell lymphoma ( DLBCL ) ( Richter 's syndrome ( RS ) ) is a rare ( 2-15 % of patients ) but catastrophic complication of B-CLL .
BACKGROUND	Dose-intense chemotherapy regimens investigated in small single institution trials , but with the exception of bone marrow transplantation for a minority of patients , little has improved the median overall survival of patients with RS beyond eight months .
BACKGROUND	Patients are often elderly , immunosuppressed , possess co-morbidities and have a deteriorating performance status .
BACKGROUND	TP53 disruption is a common molecular abnormality noted in RS and contributes to the tumour 's chemotherapy resistance .
BACKGROUND	Ofatumumab is a fully human anti-CD20 monoclonal IgG1 antibody that targets a unique epitope on B lymphocytes .
BACKGROUND	It has displayed increased binding affinity and a longer dissociation time when compared to rituximab resulting in improved complement dependent cellular cytotoxicity ( CDCC ) ; a mechanism with the potential to overcome apoptosis-resistance in TP53 disruption .
BACKGROUND	Given the prevalence of TP53 disruption in RS , Ofatumumab was considered a relatively non-toxic agent with a sound rationale to test in a prospective multicentre trial as an adjunct to CHOP induction and subsequent ofatumumab maintenance therapy in responding patients .
METHODS	The CHOP-OR study is a prospective phase II study to evaluate the safety , feasibility and activity of a CHOP chemotherapy in combination with ofatumumab in induction and subsequent maintenance for patients with newly diagnosed RS .
METHODS	The primary objective will be the overall response rate ( ORR ) in patients with RS after six cycles of CHOP-O .
METHODS	The secondary objectives include feasibility of recruitment , progression free survival ( PFS ) , overall survival ( OS ) and toxicity .
METHODS	The study will be accompanied by exploratory analysis of the genomic landscape of RS in newly diagnosed patients .
CONCLUSIONS	The CHOP-OR trial evaluates the safety , feasibility and activity of CHOP plus Ofatumumab induction and Ofatumumab maintenance in new RS patients .
CONCLUSIONS	The study is currently recruiting and has met the interim analysis criteria , with more than 7 of the first 25 participants achieving a CR or PR after six cycles of CHOP-O .
CONCLUSIONS	The study has the potential to identify predictive biomarkers for this treatment modality .
BACKGROUND	NCT01171378 .

###24388167
OBJECTIVE	Dinaciclib ( MK-7965 , formerly SCH 727965 ) , a novel , small-molecule inhibitor of cyclin-dependent kinases , has been shown to induce apoptosis in preclinical studies of human tumor cell lines , including non-small cell lung cancer ( NSCLC ) cells .
OBJECTIVE	Erlotinib , an epidermal growth factor receptor inhibitor , is approved for the treatment of advanced NSCLC as second - or third-line therapy .
OBJECTIVE	This phase 2 , randomized , multicenter , open-label study compared dinaciclib with erlotinib in patients with previously treated NSCLC .
METHODS	The study was comprised of 2 parts : in part 1 , patients were randomized to either intravenous ( IV ) dinaciclib ( 50 mg/m2 ) or oral erlotinib ( 150 mg ) using an adaptive Bayesian design that adjusted the randomization ratio in favor of the more active arm , and in part 2 , patients who had progressed on erlotinib were permitted to cross over to receive dinaciclib at the same dosage as in part 1 .
METHODS	Patients were followed until disease progression or death , initiation of nonstudy cancer treatment , discontinuation , or withdrawal of consent .
METHODS	The primary efficacy end point was time-to-progression ( TTP ) in part 1 and objective response rate ( ORR ) in part 2 .
RESULTS	Based on Kaplan-Meier estimates , the median TTP was 1.49 months ( 95 % confidence interval [ CI ] : 1.31 , 2.63 ) following initial treatment with dinaciclib , compared with 1.58 months ( 95 % CI : 1.38 , 2.83 ) with erlotinib .
RESULTS	No objective responses were observed following initial treatment with dinaciclib .
RESULTS	Common severe ( grade 3 or 4 ) drug-related adverse effects included neutropenia , leukopenia , vomiting , and diarrhea .
CONCLUSIONS	Dinaciclib , administered IV , was well tolerated at the 50 mg/m2 dose , but does not have activity as monotherapy in previously treated NSCLC .
CONCLUSIONS	Evaluation of dinaciclib in combination with other agents for other indications including breast cancer and multiple myeloma is in progress .

###24717427
BACKGROUND	Few studies have investigated objective markers of lipodystrophy in African children .
BACKGROUND	We compared body circumferences , skin-fold thickness ( SFT ) and lipids in antiretroviral therapy ( ART ) - naive and stavudine ( d4T ) - exposed children with HIV-uninfected controls .
METHODS	In the CHAPAS-3 trial , HIV-infected children ( ART-naive or on d4T for 2 years without clinical lipodystrophy ) were randomized to d4T , abacavir or zidovudine with lamivudine ( 3TC ) plus a non-nucleoside reverse transcriptase inhibitor .
METHODS	Mid-upper-arm circumference ( MUAC ) and calf circumference ( CC ) , SFT ( biceps , triceps , sub-scapular and supra-iliac ) and fasting lipids ( total cholesterol [ TC ] , low-density lipoprotein [ LDL ] , high-density lipoprotein [ HDL ] and triglycerides [ TRIG ] ) were measured at randomization in all HIV-infected children , and in HIV-uninfected controls .
METHODS	Age - and sex-adjusted z-scores of MUAC , CC , SFT and the sum of SFT ( SSF ) using Dutch reference data were compared across groups using linear regression .
RESULTS	Of 496 children , 49 % were male , 299 ( median age 2.5 years [ IQR 1.5-4 .0 ] ) were ART-naive , 109 ( median age 6 years [ IQR 5.5-7 .0 ] ) were ART-experienced and 88 ( median age 2.2 years [ IQR 1.5-3 .0 ] ) were control children .
RESULTS	Overall , 100 % and 95 % of ART-experienced children had been on d4T plus 3TC and nevirapine , respectively , for a median 3.5 years ( IQR 2.6-4 .2 ) .
RESULTS	Mean ( sd ) weight-for-age z-scores and MUAC z-scores were -1.51 ( 1.29 ) versus -0.90 ( 0.88 ) versus -0.33 ( 1.15 ) and -1.56 ( 1.25 ) versus -1.24 ( 0.97 ) versus -0.65 ( 1.06 ) in ART-naive versus - experienced versus controls , respectively ( all P < 0.02 ) .
RESULTS	The mean ( sd ) of SSF was lower in the ART-experienced ( -0.78 [ 1.28 ] ) than in the ART-naive ( -0.32 [ 1.09 ] ; P < 0.0001 ) children and controls ( -0.29 [ 0.88 ] ; P < 0.002 ) .
RESULTS	ART-experienced children had higher mean fasting TC , LDL and HDL but lower TRIG compared to ART-naive children ( P-values < 0.0001 ) , and higher TC and HDL but lower TRIG compared to controls ( P-values < 0.01 ) .
CONCLUSIONS	In ART-experienced children on d4T-containing regimens , we observed lower SFT and higher TC and LDL values compared to ART-naive children and HIV-uninfected controls .

###24867906
OBJECTIVE	The aim of this trial is to search effectiveness of specifically adapted exercise programs on its own and with low back school on pain , disability , trunk and quadriceps muscle strength , walking performance , spinal mobility , quality of life ( QOL ) , and depression in the patients with chronic low back pain ( CLBP ) .
METHODS	A total of 121 patients with definite CLBP were included in this study .
METHODS	The patients were randomized into two groups .
METHODS	Group 1 ( n = 60 ) was given exercises only and accepted as the control group .
METHODS	Group 2 ( n = 61 ) received back school program and exercises .
METHODS	The exercise treatment was performed 3 days a week , for 3 months .
METHODS	The pain ( visual analog scale , VAS ) , disability ( Oswestry Disability Questionnaire , ODQ ) , walking performance ( 6 minute walking test , 6MWT ) , depression ( Beck Depression Inventory scores , BDI ) , and QOL ( Short Form 36 , SF-36 ) of all participants were evaluated .
METHODS	The trunk and knee muscle strength were measured with a handheld dynamometer .
METHODS	Patients were assessed at baseline ( BT ) , at the end of treatment ( AT ) , and at the six month follow-up ( F ) .
RESULTS	Statistically significant improvements were found between groups regarding all of the clinical parameters over time .
RESULTS	Pain , disability , muscle strength , endurance , 6MWT , mobility , QOL , and depression of both groups also showed improvements AT .
RESULTS	These improvements persisted at 6-months follow-ups ( P < 0.05 ) .
RESULTS	There were statistically significant differences between the groups for pain , disability , muscle strength , endurance , 6MWT , QOL , and depression regarding the change scores between AT-BT test and F-BT test ( P < 0.05 ) .
RESULTS	Group 2 improved more than group 1 except for mobility .
CONCLUSIONS	Exercise programs can be modified and used successfully in CLBP and this effect can be increased with addition of back school further .
METHODS	Diagnostic study Level-I-I ( prospective study ) .

###24568910
OBJECTIVE	To evaluate the value of exhaled nitric oxide in the severity evaluation of asthmatic children with remitting rhinitis .
METHODS	A total of 214 asthmatic children were randomly allocated to a untreated control and a conventional treatment group .
METHODS	Patients in each of the two subclasses were classified as asthma with concurrent rhinitis and asthma without concurrent rhinitis .
METHODS	Values of the 20 % fall in forced expiratory volume in 1 second ( PC20FEV1 ) and fractional exhaled nitric oxide ( FeNO ) were measured .
RESULTS	The PC20FEV1 level was significantly higher in untreated asthma patients without rhinitis than in those with concurrent rhinitis ( P < 0.05 ) , while FeNO was not significantly different between these two groups ( P > 0.05 ) .
RESULTS	There were no significant differences in both FeNO and PC20FEV1 between treated asthma patients with and without concurrent rhinitis ( P > 0.05 ) .
RESULTS	PC20FEV1 was significantly increased ( P < 0.05 ) but FeNO was significantly decreased ( P < 0.05 ) in asthma patients with concurrent rhinitis after conventional treatment .
RESULTS	In asthmatic children without concurrent rhinitis , treatment significantly decreased the level of FeNO ( P < 0.05 ) but had not effect on PC20FEV1 ( P > 0.05 ) .
CONCLUSIONS	Exhaled nitric oxide measurement may be useful in the severity evaluation of asthmatic children with remitting rhinitis .

###24322216
METHODS	Randomized , within-in participant cross-over study .
OBJECTIVE	The purpose of this study was to determine the effect on comfort and pressure of lying with the shoulders and bed in different positions for people with tetraplegia .
METHODS	Rehabilitation hospital .
METHODS	Twenty people with tetraplegia were tested lying supine with the shoulders and bed in seven different positions .
METHODS	The positions used a combination of three arm and two bed positions .
METHODS	Six of the positions reflected what is commonly recommended in acute spinal cord injury units including a crucifix-type position .
METHODS	The seventh position was selected by participants and reflected their preferred sleeping position .
METHODS	There were five outcomes : general comfort , shoulder comfort , participant choice of preferred position , peak pressure under the shoulders and areal pressure under the shoulders .
METHODS	Pressure was measured using a pressure mapping system and comfort using a visual analogue scale ( VAS ) .
RESULTS	The participants reported significantly higher ( P < 0.01 ) general comfort and shoulder comfort in their self-selected position compared with all other positions .
RESULTS	There was no statistical difference in peak pressure ( P = 0.15 ) or areal pressure ( P = 0.08 ) under the shoulders between the seven positions .
RESULTS	Most participants indicated that they preferred to lie with their shoulders adducted and internally rotated and the hands either by their sides or on their stomachs .
CONCLUSIONS	The position of the shoulders has little effect on pressure but a notable effect on comfort .
CONCLUSIONS	Participants preferred to sleep with their arms beside their bodies , not with their arms in a crucifix position as commonly advocated .

###25230350
OBJECTIVE	To compare the effects of topical nonsteroidal anti-inflammatory drugs on pupil dilation maintenance during phacoemulsification cataract surgery and quantify the relationships between pupil size change and nuclear hardness .
METHODS	This prospective randomized clinical observation study was single centered and double-masked .
METHODS	We studied 239 cases undergoing uneventful phacoemulsification cataract surgery in the absence of significant ocular comorbidity .
METHODS	Cases were randomly assigned to 1 of 6 groups receiving the following treatments : ( 1 ) diclofenac ( 0.1 % ) ; ( 2 ) pranoprofen ( 0.1 % ) ; ( 3 ) control , physiological normal saline solution ; ( 4 ) diclofenac ( 0.1 % ) and epinephrine ; ( 5 ) pranoprofen ( 0.1 % ) and epinephrine ; ( 6 ) control , physiological normal saline and epinephrine solutions .
METHODS	Pupil diameter was measured at 3 intervals of cataract surgery : before the first incision , at the end of nucleus fragmentation , and at the end of cortex irrigation/aspiration .
RESULTS	Compared with patients who were not treated , there was a significant difference in maintaining pupil dilation throughout the operation when the patients were treated with either diclofenac or pranoprofen , P < 0.001 and P < 0.03 , respectively .
RESULTS	From the first incision to postnucleus fragmentation , the change in pupil size in both diclofenac and control groups was significantly associated with the hardness of the crystalline lens , P = 0.001 and P = 0.012 , respectively .
RESULTS	At the end of irrigation/aspiration , the change in pupil size in only the control groups was significantly associated with the hardness of the crystalline lens , P = 0.022 .
RESULTS	Diclofenac treatment was most effective at inhibiting pupil miosis when the hardness of the nucleus was grade 3 , P = 0.009 .
RESULTS	Pupil miosis was not related to the hardness of the nucleus when the patients were treated with epinephrine .
CONCLUSIONS	Both diclofenac and pranoprofen treatment inhibit surgical-induced miosis .
CONCLUSIONS	There is a negative correlation between the hardness of the crystalline lens and pupil diameter maintenance at the early stage of phacoemulsification .

###24560584
OBJECTIVE	To assess whether the administration of symbiotic preparations in patients with multi-organ failure ( MOF ) diminishes the evolution of the failure , the inflammatory response generated , the colonization pattern and the Intensive Care Unit ( ICU ) infectious illness .
METHODS	Randomized and controlled trial .
METHODS	All patients with MOF were included .
METHODS	Neutropenia and acute pancreatitis patients were excluded .
METHODS	A symbiotic ( Simbiotic Drink ) was administered via enteral feeding during the first 7 days .
METHODS	Variables of interest were : Sequential Organ Failure Assessment ( SOFA ) score evolution , systemic concentrations of lactate , fibrinogen and D-dimer ; skin and mucosa colonization and infectious disease register .
RESULTS	Eighty-nine patients were included ; 46 in the symbiotic group ( SG ) and 43 in the control group ( CG ) .
RESULTS	There were 68.5 % males , with a median age of 69 years .
RESULTS	There were no significant differences in the patients ' fundamental characteristics ( medical history , age , reason for admission , severity scores ) , nor in the length of ICU stay or in mortality .
RESULTS	Comparing the SG with the CG , there were lower lactate levels on the second day , more fibrinogen levels on the days 5 and 7 , and lower D-dimer levels on the day 7 .
RESULTS	Eight hundred and ninety-five cultures were performed for colonization assessment , with isolation of 528 microorganisms .
RESULTS	No differences in microbiological resistance were found ; there were more colonization in the SG by Candida in mucous membranes after the third day ; this situation resolved after stopping symbiotic administration .
RESULTS	Twenty-two patients suffered an infectious disease in ICU , 14 in SG ( 42.4 % ) and 19 in CG ( 57.6 % ) .
RESULTS	Although no differences were found in the microbiological pattern , there was a predominance of Candida spp .
RESULTS	over other microorganisms ( 4 vs. 0 cases ) .
CONCLUSIONS	The symbiotic preparation Simbiotic Drink , administered in MOF , results in differences to improve the early lactate levels and late fibrinogen/D-dimer levels as well as mucosa colonization by Candida .
CONCLUSIONS	There were no differences in the ICU evolution .

###24478050
METHODS	Whole-grain foods have been reported to affect serum levels of inflammatory cytokines .
METHODS	However , we are aware of no study examining the effect of whole-grain intake on inflammatory biomarkers among children .
METHODS	The present study aimed to determine the effect of whole-grain intake on serum levels of inflammatory biomarkers in overweight or obese children .
RESULTS	In this randomized crossover clinical trial , 44 overweight or obese girls aged 8-15 years participated .
RESULTS	After a 2-week run-in period , subjects were randomly assigned to either whole-grain or control groups .
RESULTS	Subjects in the whole-grain group were given a list of whole-grain foods and were asked to obtain half of their needed servings of grains from whole-grain foods each day for 6 weeks .
RESULTS	Individuals in the control group were also given a list of whole-grain foods and were asked not to consume any of these foods during the intervention phase of the study .
RESULTS	A 4-week washout period was applied following which subjects were crossed over to the alternate arm for an additional 6 weeks .
RESULTS	Fasting blood samples were taken before and after each phase of the study to quantify markers of systemic inflammation .
RESULTS	Mean age , weight , and BMI of study participants were 11.2 1.49 years , 51.2 10.2 kg , and 23.5 2.5 kg/m ( 2 ) , respectively .
RESULTS	No significant effect of whole-grain intake on weight and BMI was seen compared with the control group .
RESULTS	We found a significant effect of whole-grain intake on serum levels of high-sensitive C-reactive protein ( -21.8 versus +12.1 % , p = 0.03 ) , soluble intercellular adhesion molecule-1 ( -28.4 versus +6.3 % , p = 0.02 ) , serum amyloid A ( -17.4 versus +9.9 % , p = 0.02 ) , and leptin ( -9.7 versus +39.2 % , p = 0.02 ) after 6 weeks .
RESULTS	A trend toward the significant effect of whole-grain intake on serum levels of soluble vascular cell adhesion molecule-1 ( -36.2 % versus -7.8 % , p = 0.07 ) was also observed .
CONCLUSIONS	This study provides evidence supporting the beneficial effects of whole-grain foods on biomarkers of systemic inflammation in obese children .

###24270304
OBJECTIVE	This study addresses methods for training respirator users , particularly when occupational health professionals are not immediately available .
METHODS	A randomized trial compared three training methods-printed brochure , video , and computer-based training-for two respirator types ( filtering facepiece and a dual-cartridge half facemask ) .
METHODS	Quantitative fit testing ( PortaCount ) measured the effectiveness of training .
METHODS	The study included 226 subjects .
RESULTS	For both respirator types , video was significantly superior to either print or computer-based training methods .
RESULTS	Conclusions were consistent , whether determined by average fit factor ( analysis of variance ) , log-transformed fit factors , or the number of users in the lowest quartile of achieved fit .
CONCLUSIONS	Video training for proper respirator use can be effective when direct training from an occupational health professional is unavailable .
CONCLUSIONS	These methods are particularly relevant to `` rapid rollout '' situations , such as natural disasters , epidemics , or bioterrorism concerns .

###25506771
OBJECTIVE	Widening socioeconomic disparities in mortality in the United States are largely explained by slower declines in tobacco use among smokers of low socioeconomic status ( SES ) than among those of higher SES , which points to the need for targeted tobacco cessation interventions .
OBJECTIVE	Documentation of smoking status in electronic health records ( EHRs ) provides the tools for health systems to proactively offer tobacco treatment to socioeconomically disadvantaged smokers .
OBJECTIVE	To evaluate a proactive tobacco cessation strategy that addresses sociocontextual mediators of tobacco use for low-SES smokers .
METHODS	This prospective , randomized clinical trial included low-SES adult smokers who described their race and/or ethnicity as black , Hispanic , or white and received primary care at 1 of 13 practices in the greater Boston area ( intervention group , n = 399 ; control group , n = 308 ) .
METHODS	We analyzed EHRs to identify potentially eligible participants and then used interactive voice response ( IVR ) techniques to reach out to them .
METHODS	Consenting patients were randomized to either receive usual care from their own health care team or enter an intervention program that included ( 1 ) telephone-based motivational counseling , ( 2 ) free nicotine replacement therapy ( NRT ) for 6 weeks , ( 3 ) access to community-based referrals to address sociocontextual mediators of tobacco use , and ( 4 ) integration of all these components into their normal health care through the EHR system .
METHODS	Self-reported past-7-day tobacco abstinence 9 months after randomization ( `` quitting '' ) , assessed by automated caller or blinded study staff .
RESULTS	The intervention group had a higher quit rate than the usual care group ( 17.8 % vs 8.1 % ; odds ratio , 2.5 ; 95 % CI , 1.5-4 .0 ; number needed to treat , 10 ) .
RESULTS	We examined whether use of intervention components was associated with quitting among individuals in the intervention group : individuals who participated in the telephone counseling were more likely to quit than those who did not ( 21.2 % vs 10.4 % ; P < .001 ) .
RESULTS	There was no difference in quitting by use of NRT .
RESULTS	Quitting did not differ by a request for a community referral , but individuals who used their referral were more likely to quit than those who did not ( 43.6 % vs 15.3 % ; P < .001 ) .
CONCLUSIONS	Proactive , IVR-facilitated outreach enables engagement with low-SES smokers .
CONCLUSIONS	Providing counseling , NRT , and access to community-based resources to address sociocontextual mediators among smokers reached in this setting is effective .
BACKGROUND	clinicaltrials.gov Identifier : NCT01156610 .

###24557960
OBJECTIVE	Sequential therapy is one of the recent answers given to the problem of increasing antibiotic resistance and decreasing eradication rates of Helicobacter pylori infection .
OBJECTIVE	The aim of this study is to compare the ornidazole-based sequentialtherapy with the standard triple therapy in Helicobacter pylori eradication .
METHODS	Children aged 4-18 years diagnosed with Helicobacter pylori infection based on histology and at least one of 13 C urea breath test and rapid urease test positivity were included in the study .
METHODS	Children were randomized to standard triple therapy with amoxicillin , clarithromycin , and lansoprazole for 14 days and sequential therapy with amoxicillin and lansoprazole for the first 5 days and clarithromycin , ornidazole and lansoprazole for another 5 days in 2:3 randomization .
METHODS	At the end of the treatment , families were contacted by phone , and side effects of and the compliance to the treatment were noted .
METHODS	Patients were requested to do 13 C urea breath test 6-8 weeks after the treatment .
RESULTS	Sixty-one children were included for the final analysis .
RESULTS	Per-protocol eradication rates were 48.6 % for sequential therapy group and 54.2 % for standard triple therapy group .
RESULTS	Intention to treat eradication rates were 40.9 % and 46.0 % , respectively .
RESULTS	There were no differences between eradication rates in the two study groups .
RESULTS	Side effect rates were also similar between the two groups .
CONCLUSIONS	Ornidazole-based sequential therapy did not show any superiority compared to the standard triple treatment in children with Helicobacter pylori infection .

###25605841
OBJECTIVE	The purpose of this study was to compare illness-related anxiety among participants in the Rituximab Extended Schedule or Retreatment Trial ( RESORT ) randomly assigned to maintenance rituximab ( MR ) versus rituximab re-treatment ( RR ) .
OBJECTIVE	A secondary objective was to examine whether the superiority of MR versus RR on anxiety depended on illness-related coping style .
METHODS	Patients ( N = 253 ) completed patient-reported outcome ( PRO ) measures at random assignment to MR or RR ( baseline ) ; at 3 , 6 , 12 , 24 , 36 , and 48 months after random assignment ; and at rituximab failure .
METHODS	PRO measures assessed illness-related anxiety and coping style , and secondary end points including general anxiety , worry and interference with emotional well-being , depression , and health-related quality of life ( HRQoL ) .
METHODS	Patients were classified as using an active or avoidant illness-related coping style .
METHODS	Independent sample t tests and linear mixed-effects models were used to identify treatment arm differences on PRO end points and differences based on coping style .
RESULTS	Illness-related anxiety was comparable between treatment arms at all time points ( P > .05 ) , regardless of coping style ( active or avoidant ) .
RESULTS	Illness-related anxiety and general anxiety significantly decreased over time on both arms .
RESULTS	HRQoL scores were relatively stable and did not change significantly from baseline for both arms .
RESULTS	An avoidant coping style was associated with significantly higher anxiety ( 18 % and 13 % exceeded clinical cutoff points at baseline and 6 months , respectively ) and poorer HRQoL compared with an active coping style ( P < .001 ) , regardless of treatment arm assignment .
CONCLUSIONS	Surveillance until RR at progression was not associated with increased anxiety compared with MR , regardless of coping style .
CONCLUSIONS	Avoidant coping was associated with higher anxiety and poorer HRQoL .

###26263592
OBJECTIVE	A two-year study assessed the benefit of an enhanced oral health promotion program combined with a closely supervised tooth brushing program in schools , using toothpaste containing 1,450 ppm F - and 1.5 % arginine , on oral health and dental caries .
METHODS	15 southern Thailand schools and 3,706 pre-school children were recruited : 8 schools with 1,766 children as controls ; 7 schools with 1,940 children in the intervention groups .
METHODS	Of the intervention schools five were classified as cooperative school and two as non-cooperative schools , based on the criteria of 80 % participation in the prescribed tooth brushing activities .
RESULTS	The DMFT and DMFS increments ( `` enamel and dentine '' ) were 1.19 and 1.91 for the control group and 1.04 and 1.59 for the intervention groups .
RESULTS	These represent 12.6 % and 16.8 % reductions in caries respectively .
RESULTS	The DMFT and DMFS increments ( `` dentine threshold '' ) were 0.26 and 0.44 for the control group and 0.19 and 0.29 for the intervention group , representing 26.9 % , and 34.1 % reductions in caries incidence respectively .
RESULTS	For the more cooperative schools the benefits were greater : up to a 40.9 % reduction in caries for DMFS ( `` dentine threshold '' ) .
RESULTS	At the 24 month examination there were significant improvements in dental plaque scores with greater improvements seen in the intervention group , greater still in the cooperative schools .
CONCLUSIONS	This study documents the positive effect from use of fluoridated toothpaste ( 1,450 ppm F - and 1.5 % arginine ) administered by schoolteachers and undertaken via an enhanced school oral health program .
CONCLUSIONS	Optimising oral health interventions for young children in Thai schools may have a significant impact on caries incidence resulting in reductions of up to 34 % reductions in caries for all schools included in the study and up to 41 % for the most cooperative .

###24788563
BACKGROUND	Activation of the vascular endothelial growth factor receptor ( VEGFR ) and the oncogenic Src pathway has been implicated in the development of castration-resistant prostate cancer ( CRPC ) in preclinical models .
BACKGROUND	Cediranib and dasatinib are multi-kinase inhibitors targeting VEGFR and Src respectively .
BACKGROUND	Phase II studies of cediranib and dasatinib in CRPC have shown single agent activity .
METHODS	Docetaxel-pretreated CRPC patients were randomized to arm A : cediranib alone ( 20 mg/day ) versus arm B : cediranib ( 20 mg/day ) plus dasatinib ( 100 mg/day ) given orally on 4-week cycles .
METHODS	Primary endpoint was 12-week progression-free survival ( PFS ) as per the Prostate Cancer Clinical Trials Working Group ( PCWG2 ) .
METHODS	Patient reported outcomes were evaluated using Functional Assessment of Cancer Therapy-Prostate ( FACT-P ) and Present Pain Intensity ( PPI ) scales .
METHODS	Correlative studies of bone turnover markers ( BTM ) , including bone alkaline phosphate ( BAP ) and serum beta-C telopeptide ( B-CTx ) were serially assayed .
METHODS	Results A total of 22 patients , 11 per arm , were enrolled .
METHODS	Baseline demographics were similar in both arms .
METHODS	Median number of cycles = 4 in arm A ( range 1-12 ) and 2 in arm B ( range 1-9 ) .
METHODS	Twelve-week PFS was 73 % in arm A versus 18 % in arm B ( p = 0.03 ) .
METHODS	Median PFS in months ( arm A versus B ) was : 5.2 versus 2.6 ( 95 % CI : 1.9-6 .5 versus 1.4-not reached ) .
METHODS	Most common grade 3 toxicities were hypertension , anemia and thrombocytopenia in arm A and hypertension , diarrhea and fatigue in arm B.
METHODS	One treatment-related death ( retroperitoneal hemorrhage ) was seen in arm A. FACT-P and PPI scores did not significantly change in either arm .
METHODS	No correlation between BTM and PFS was seen in either arm .
CONCLUSIONS	Although limited by small numbers , this randomized study showed that the combination of VEGFR and Src targeted therapy did not result in improved efficacy and may be associated with a worse outcome than VEGFR targeted therapy alone in patients with CRPC .
CONCLUSIONS	ClinicalTrials.gov number : NCT01260688 .

###25699352
OBJECTIVE	Colonoscopy is associated with pain and discomfort in the majority of patients when performed without sedation .
OBJECTIVE	We performed a prospective and randomized study to compare warm water instillation and standard air-insufflation colonoscopy techniques without any sedation .
METHODS	The data of 122 patients ( 64 female and 58 male ) were statistically analyzed .
METHODS	Patients were randomized into two groups by using computer generated list .
METHODS	In group A , standard colonoscopy with air insufflation was performed .
METHODS	In group B colonoscopy was performed by warm water infusion into the bowel .
METHODS	No analgesic , antispasmodic or sedative medications were used .
METHODS	After colonoscopy , the level of pain during colonoscopy experienced by the patient was measured using the visual analog scale ( VAS ) .
RESULTS	There were no statistically significant differences in gender and average age between the two groups of patients .
RESULTS	Cecal intubation was successful in all patients ( 100 % ) .
RESULTS	All colonoscopies were performed without complications .
RESULTS	Patients who had colonoscopy with water immersion had a significantly lower level of pain on the VAS ( 4.09 vs 5.06 ) , p = 0.041 .
CONCLUSIONS	We confirmed the advantages of warm water instillation for colonoscope insertion in reducing pain without compromising the time to reach the cecum , success of cecum intubation or patient safety .

###25611308
OBJECTIVE	To evaluate safety , ocular tolerability and pharmacokinetics of 0.5 % and 2.5 % cis-urocanic acid ( cis-UCA ) eye drops .
METHODS	In this phase I , double-blinded , placebo-controlled trial , 37 healthy volunteers were randomized to three treatment arms : 0.5 % cis-UCA ( 12 subjects ) , 2.5 % cis-UCA ( 12 subjects ) and placebo eye drops ( 13 subjects ) .
METHODS	In the first part , the subjects were dosed topically on a randomized eye with one drop three times at 7 1 hr intervals during 1 day .
METHODS	In the second part , the subjects self-administered three daily drops at 7 1 hr intervals on both eyes for 14 days .
METHODS	Physical examination of the eyes was performed seven times during the study .
METHODS	Tolerability of cis-UCA was assessed by ocular comfort rating questionnaire .
METHODS	Pharmacokinetic blood and urine samples were analysed under good laboratory practice ( GLP ) .
RESULTS	All subjects completed both parts of the study .
RESULTS	There were no significant adverse events ( AEs ) .
RESULTS	The most common treatment-related ocular AE was eye irritation ( 62.2 % of subjects ) .
RESULTS	Cis-UCA concentrations in plasma remained below the limit of quantification ( 0.195 g/ml ) in all but two subjects .
RESULTS	The fraction of the administered drug excreted into urine over the total collection period ranged from 3.2 % to 61.6 % of the last dose and from 1.1 % to 20.5 % of the daily dose .
CONCLUSIONS	Topical ocular administration of cis-UCA solution is safe and apart from mild - and short-lasting eye irritation after administration well tolerated in healthy adult subjects .
CONCLUSIONS	Topical ocular dosing leads to transient systemic exposure to cis-UCA that does not cause systemic AEs .

###25487965
OBJECTIVE	Diode lasers are becoming popular in gingival treatment following orthodontic treatments .
OBJECTIVE	Despite their merit and clinical implications , postoperative pain and bleeding after surgery with diode lasers are not assessed except in few controversial studies .
METHODS	This controlled clinical trial was conducted on 30 healthy orthodontic patients aged 17-29 years , needing esthetic-only gingivectomy in the anterior maxilla .
METHODS	The patients were randomly divided into two groups of 15 each : experimental ( laser-assisted surgery ) and control ( traditional surgery using scalpels ) .
METHODS	The bleeding rate following the surgery was assessed using the bleeding criteria established by the World Health Organization .
METHODS	The postsurgical pain level was recorded using visual analog scales immediately after the surgery and in patients who consumed analgesics , also 2 h after the analgesic consumption .
METHODS	The data were analyzed using the independent-samples t , Mann-Whitney U , and chi-square tests ( = 0.05 ) .
RESULTS	The average bleeding rates were 1.15 and 0.36 in the conventional and laser groups , respectively ( Mann-Whitney U P < 0.05 ) .
RESULTS	Experimental patients had no postsurgical pain ( VAS1 and VAS2 = 0 ) .
RESULTS	In the control group , the average VAS1 pain was 5.2 out of 10 .
RESULTS	The difference between VAS1 values in the control/experimental groups was significant ( Mann-Whitney U P < 0.001 ) .
CONCLUSIONS	940-nm diode laser seems promising in reducing postoperative bleeding and pain of patients needing cosmetic smile lift surgeries .

###25098442
BACKGROUND	Theory-based process evaluations conducted alongside randomized controlled trials provide the opportunity to investigate hypothesized mechanisms of action of interventions , helping to build a cumulative knowledge base and to inform the interpretation of individual trial outcomes .
BACKGROUND	Our objective was to identify the underlying causal mechanisms in a cluster randomized trial of the effectiveness of printed educational materials ( PEMs ) to increase referral for diabetic retinopathy screening .
BACKGROUND	We hypothesized that the PEMs would increase physicians ' intention to refer patients for retinal screening by strengthening their attitude and subjective norm , but not their perceived behavioral control .
METHODS	Design : A theory based process evaluation alongside the Ontario Printed Educational Material ( OPEM ) cluster randomized trial .
METHODS	Postal surveys based on the Theory of Planned Behavior were sent to a random sample of trial participants two months before and six months after they received the intervention .
METHODS	Setting : Family physicians in Ontario , Canada .
METHODS	Participants : 1,512 family physicians ( 252 per intervention group ) from the OPEM trial were invited to participate , and 31.3 % ( 473/1512 ) responded at time one and time two .
METHODS	The final sample comprised 437 family physicians fully completing questionnaires at both time points .
METHODS	Main Outcome Measures : Primary : behavioral intention related to referring patient for retinopathy screening ; secondary : attitude , subjective norm , perceived behavioral control .
RESULTS	At baseline , family physicians reported positive intention , attitude , subjective norm , and perceived behavioral control to advise patients about retinopathy screening suggesting limited opportunities for improvement in these constructs .
RESULTS	There were no significant differences on intention , attitude , subjective norm , and perceived behavioral control following the intervention .
RESULTS	Respondents also reported additional physician - and patient-related factors perceived to influence whether patients received retinopathy screening .
CONCLUSIONS	Lack of change in the primary and secondary theory-based outcomes provides an explanation for the lack of observed effect of the main OPEM trial .
CONCLUSIONS	High baseline levels of intention to advise patients to attend retinopathy screening suggest that post-intentional and other factors may explain gaps in care .
CONCLUSIONS	Process evaluations based on behavioral theory can provide replicable and generalizable insights to aid interpretation of randomized controlled trials of complex interventions to change health professional behavior .
BACKGROUND	ISRCTN72772651 .

###25180378
OBJECTIVE	To determine whether cranberry capsules prevent urinary tract infection ( UTI ) in long-term care facility ( LTCF ) residents .
METHODS	Double-blind randomized placebo-controlled multicenter trial .
METHODS	Long-term care facilities ( LTCFs ) .
METHODS	LTCF residents ( N = 928 ; 703 women , median age 84 ) .
METHODS	Cranberry and placebo capsules were taken twice daily for 12 months .
METHODS	Participants were stratified according to UTI risk ( risk factors included long-term catheterization , diabetes mellitus , 1 UTI in preceding year ) .
METHODS	Main outcomes were incidence of UTI according to a clinical definition and a strict definition .
RESULTS	In participants with high UTI risk at baseline ( n = 516 ) , the incidence of clinically defined UTI was lower with cranberry capsules than with placebo ( 62.8 vs 84.8 per 100 person-years at risk , P = .04 ) ; the treatment effect was 0.74 ( 95 % confidence interval ( CI ) = 0.57-0 .97 ) .
RESULTS	For the strict definition , the treatment effect was 1.02 ( 95 % CI = 0.68-1 .55 ) .
RESULTS	No difference in UTI incidence between cranberry and placebo was found in participants with low UTI risk ( n = 412 ) .
CONCLUSIONS	In LTCF residents with high UTI risk at baseline , taking cranberry capsules twice daily reduces the incidence of clinically defined UTI , although it does not reduce the incidence of strictly defined UTI .
CONCLUSIONS	No difference in incidence of UTI was found in residents with low UTI risk .

###25273342
BACKGROUND	Combining bevacizumab with first-line or second-line chemotherapy improves progression-free survival in HER2-negative locally recurrent or metastatic breast cancer .
BACKGROUND	We assessed the efficacy and safety of further bevacizumab therapy in patients with locally recurrent or metastatic breast cancer whose disease had progressed after treatment with bevacizumab plus chemotherapy .
METHODS	In this open-label , randomised , phase 3 trial , we recruited patients who had HER2-negative locally recurrent or metastatic breast cancer that had progressed after receiving 12 weeks or more of first-line bevacizumab plus chemotherapy from 118 centres in 12 countries .
METHODS	Patients were randomly assigned ( 1:1 ) by use of a central interactive voice response system using a block randomisation schedule ( block size four ) stratified by hormone receptor status , first-line progression-free survival , selected chemotherapy , and lactate dehydrogenase concentration , to receive second-line single-agent chemotherapy either alone or with bevacizumab ( 15 mg/kg every 3 weeks or 10 mg/kg every 2 weeks ) .
METHODS	Second-line therapy was continued until disease progression , unacceptable toxicity , or consent withdrawal .
METHODS	At progression , patients randomly assigned to chemotherapy alone received third-line chemotherapy without bevacizumab ; those randomly assigned to bevacizumab continued bevacizumab with third-line chemotherapy .
METHODS	The primary endpoint was progression-free survival from randomisation to second-line progression or death in the intention-to-treat population .
METHODS	This trial is ongoing , and registered with ClinicalTrials.gov , number NCT01250379 .
RESULTS	Between Feb 17 , 2011 , and April 3 , 2013 , 494 patients were randomly assigned to treatment ( 247 in each group ) .
RESULTS	The median duration of follow-up at the time of this prespecified primary progression-free survival analysis was 159 months ( IQR 91-217 ) in the chemotherapy-alone group and 161 months ( 106-227 ) in the combination group .
RESULTS	Progression-free survival was significantly longer for those patients treated with bevacizumab plus chemotherapy than for those with chemotherapy alone ( median : 63 months [ 95 % CI 54-72 ] vs 42 months [ 39-47 ] , respectively , stratified hazard ratio [ HR ] 075 [ 95 % CI 061-093 ] , two-sided stratified log-rank p = 00068 ) .
RESULTS	The most common grade 3 or more adverse events were hypertension ( 33 [ 13 % ] of 245 patients receiving bevacizumab plus chemotherapy vs 17 [ 7 % ] of 238 patients receiving chemotherapy alone ) , neutropenia ( 29 [ 12 % ] vs 20 [ 8 % ] ) , and hand-foot syndrome ( 27 [ 11 % ] vs 25 [ 11 % ] ) .
RESULTS	Grade 3 proteinuria occurred in 17 ( 7 % ) of 245 patients receiving combination therapy and one ( < 1 % ) of 238 patients receiving chemotherapy alone .
RESULTS	Serious adverse events were reported in 61 ( 25 % ) of 245 patients receiving bevacizumab plus chemotherapy versus 44 ( 18 % ) of 238 patients receiving chemotherapy alone .
CONCLUSIONS	These results suggest that continued VEGF inhibition with further bevacizumab is a valid treatment option for patients with locally recurrent or metastatic HER2-negative breast cancer whose disease was stabilised or responded to first-line bevacizumab with chemotherapy .
BACKGROUND	F Hoffmann-La Roche .

###25123822
OBJECTIVE	Evaluate tools to help pregnant women with prior cesareans make informed decisions about having trials of labor .
METHODS	Randomized comparative trial .
METHODS	A research assistant with a laptop met the women in quiet locations at clinics and at health fairs .
METHODS	Pregnant women ( N = 131 ) who had one prior cesarean and were eligible for vaginal birth after cesarean ( VBAC ) participated one time between 2005 and 2007 .
METHODS	Women were randomized to receive either an evidence-based , interactive decision aid or two evidence-based educational brochures about cesarean delivery and VBAC .
METHODS	Effect on the decision-making process was assessed before and after the interventions .
RESULTS	Compared to baseline , women in both groups felt more informed ( F = 23.8 , p < .001 ) , were more clear about their birth priorities ( F = 9.7 , p = .002 ) , felt more supported ( F = 9.8 , p = .002 , and overall reported less conflict ( F = 18.1 , p < 0.001 ) after receiving either intervention .
RESULTS	Women in their third trimesters reported greater clarity around birth priorities after using the interactive decision aid than women given brochures ( F = 9.8 , p = .003 ) .
CONCLUSIONS	Although both decision tools significantly reduced conflict around the birth decision compared to baseline , more work is needed to understand which format , the interactive decision aid or paper brochures , are more effective early and late in pregnancy .

###25007362
BACKGROUND	Econazole nitrate is a broad-spectrum topical antifungal with activity against a variety of dermatophytes and yeasts .
BACKGROUND	A new topical dosage form , econazole nitrate topical foam 1 % , utilizing patented Proderm Technology has been developed for treatment of interdigital tinea pedis .
OBJECTIVE	To evaluate econazole nitrate foam 1 % versus foam vehicle for treatment of interdigital tinea pedis .
METHODS	Two randomized , double-blind , parallel-group , vehicle-controlled , multicenter studies enrolled males and females 12 years old with a clinical diagnosis of interdigital tinea pedis and baseline fungal culture positive for a dermatophyte .
METHODS	Subjects applied econazole nitrate foam 1 % ( n = 246 ) or foam vehicle ( n = 249 ) once daily for 4 weeks .
METHODS	The primary endpoint was proportion of subjects achieving a complete cure ( negative KOH , negative fungal culture , complete resolution of all signs and symptoms ) at 2 weeks post-treatment ( Day 43 ) .
METHODS	Secondary endpoints included mycologic cure ( negative KOH and negative culture ) and effective treatment ( mycologic cure + no or mild erythema and/or scaling and all other signs and symptoms absent ) .
RESULTS	The complete cure rate at Day 43 was 24.3 % for econazole nitrate foam 1 % vs 3.6 % for foam vehicle .
RESULTS	In addition , higher rates of mycologic cure ( 67.6 % vs 16.9 % ) and effective treatment ( 48.6 % vs 10.8 % ) were observed with econazole nitrate foam 1 % versus the foam vehicle .
RESULTS	There were few adverse events and only nasopharyngitis and headache were experienced by > 1 % of subjects .
RESULTS	No serious adverse events were reported for econazole nitrate foam 1 % .
CONCLUSIONS	Econazole nitrate foam 1 % exhibited superiority over foam vehicle for the primary and secondary endpoints with a high mycologic cure rate for all pathogens evaluated .
CONCLUSIONS	Econazole nitrate foam 1 % was safe and well tolerated with a safety profile comparable with the foam vehicle .
CONCLUSIONS	Econazole nitrate foam 1 % presents a novel alternative for the management of tinea pedis .

###25057878
OBJECTIVE	Thyroid dysfunction is associated with impaired cognitive development .
OBJECTIVE	Perchlorate decreases thyroidal iodine uptake , potentially reducing thyroid hormone production .
OBJECTIVE	It is unclear whether perchlorate exposure in early life affects neurodevelopment .
METHODS	Historical cohort analysis .
METHODS	From 2002 to 2006 , 21,846 women at gestational age < 16 weeks recruited from antenatal clinics in Cardiff , UK and Turin , Italy were enrolled in the Controlled Antenatal Thyroid Screening Study ( CATS ) .
METHODS	We undertook a retrospective analysis of 487 mother-child pairs in mothers who were hypothyroid/hypothyroxinemic during pregnancy and analyzed whether first trimester maternal perchlorate levels in the highest 10 % of the study population were associated with increased odds of offspring IQ being in the lowest 10 % at 3 years of age .
METHODS	Maternal urinary perchlorate , offspring IQ .
RESULTS	Urine perchlorate was detectable in all women ( median 2.58 g/L ) ; iodine levels were low ( median 72 g/L ) .
RESULTS	Maternal perchlorate levels in the highest 10 % of the population increased the odds of offspring IQ being in the lowest 10 % OR = 3.14 ( 95 % CI 1.38 , 7.13 ) P = .006 with a greater negative impact observed on verbal OR = 3.14 ( 95 % CI 1.42 , 6.90 ) P = .005 than performance IQ .
RESULTS	Maternal levothyroxine therapy did not reduce the negative impact of perchlorate on offspring IQ .
CONCLUSIONS	This is the first study using individual-level patient data to study maternal perchlorate exposure and offspring neurodevelopment and suggests that high-end maternal perchlorate levels in hypothyroid/hypothyroxinemic pregnant women have an adverse effect on offspring cognitive development , not affected by maternal levothyroxine therapy .
CONCLUSIONS	These results require replication in additional studies , including in the euthyroid population .

###25145377
BACKGROUND	Varenicline has been shown to significantly reduce craving and several aspects of smoking reinforcement in clinical trials , compared with placebo .
BACKGROUND	This is the first report describing the concentration-effect relationship of varenicline on relief of craving .
METHODS	The pharmacokinetics ( PK ) and pharmacodynamics ( PD ) of a single 2mg dose of varenicline were investigated in 40 smokers in a randomized , crossover study comparing the effect of varenicline with placebo on ameliorating abstinence-and cue-induced craving and withdrawal symptoms .
METHODS	Subjects were asked to complete self-reported questionnaires ( Smoking Urges Scale and Minnesota Nicotine Withdrawal Scale [ MNWS ] ) and blood samples were simultaneously collected for measurement of varenicline concentrations .
METHODS	Only the data from the 4-hr postdose abstinence period ( just prior to the cue session ) were analyzed .
METHODS	Data were described by a 2-compartment PK model and a linear PD model with first-order onset/offset rate constants describing the placebo response `` kinetics . ''
METHODS	Response was described as the net effect of the baseline , placebo , and drug responses .
RESULTS	Varenicline significantly decreased mean craving score when compared with placebo and the magnitude of this response was related to varenicline concentration .
RESULTS	The time-course and magnitude of both placebo and varenicline craving response were characterized by a large degree of unexplained variability .
RESULTS	Simulations were used to illustrate the expected craving response over time and its associated random variability after chronic dosing .
CONCLUSIONS	Craving reduction is associated with increased varenicline concentrations .
CONCLUSIONS	The relatively rapid onset of this effect within 4 hr postdose suggests that , smokers may experience some craving relief after acute administration of varenicline .

###24379169
OBJECTIVE	This study aims to evaluate the effects on physical activity ( PA ) and eating behavior ( EB ) of a tailored behavioral medicine intervention and first-time continuous positive airway pressure ( CPAP ) treatment compared with first-time CPAP treatment and advice in patients with obstructive sleep apnea syndrome ( OSAS ) and overweight .
METHODS	Seventy-three patients ( meanSD , 5512years ) with overweight ( body mass index ( BMI ) , 34.54.8 ) and moderate or severe OSAS ( Apnea-Hypopnea Index , 41.720.9 ) scheduled for CPAP prescription were randomized to a control group ( CPAP and advice on the association between weight and OSAS ) or an experimental group ( CPAP and a 6-month behavioral medicine intervention targeting PA and EB ) .
METHODS	At baseline and after 6months , eating behavior ( food frequency screening and Dutch Eating Behavior Questionnaire ) , weight , BMI , and waist circumference were assessed at one point , while PA and sedentary time were measured with accelerometry during 4days .
RESULTS	The experimental group reduced 2.1 kg ( 4.6 ) in weight and 3cm ( 4.9 ) in waist circumference , significantly more than the control group .
RESULTS	At 6months , the experimental group ate more fruit and fish/shellfish than the control group .
RESULTS	Low and moderate to vigorous PA did not change over time either within or between groups .
RESULTS	Regarding BMI , steps , and sedentary time , there were within-group differences but no differences between groups .
CONCLUSIONS	The behavioral medicine intervention did not change physical activity but facilitated changes in EB in patients with OSAS and overweight .
CONCLUSIONS	The amount of weight loss and reduction in waist circumference favored the participants receiving this treatment .
CONCLUSIONS	Since the strategies for achieving behavioral changes were tailored according to the individual 's goals and personal functional behavioral analyses and progressed slowly in a graded manner , it might require higher PA quotas or a period longer than 6months to reveal a behavioral change of larger proportions .

###25533222
BACKGROUND	Preprocedural 3-dimensional CT imaging of the aortic annular plane plays a critical role for transcatheter aortic valve replacement ( TAVR ) planning ; however , manual reconstructions are complex .
BACKGROUND	Automated analysis software may improve reproducibility and agreement between readers but is incompletely validated .
METHODS	In 110 TAVR patients ( mean age , 81 years ; 37 % female ) undergoing preprocedural multidetector CT , automated reconstruction of the aortic annular plane and planimetry of the annulus was performed with a prototype of now commercially available software ( syngo.CT Cardiac Function-Valve Pilot ; Siemens Healthcare , Erlangen , Germany ) .
METHODS	Fully automated , semiautomated , and manual annulus measurements were compared .
METHODS	Intrareader and inter-reader agreement , intermodality agreement , and interchangeability were analyzed .
METHODS	Finally , the impact of these measurements on recommended valve size was evaluated .
RESULTS	Semiautomated analysis required major correction in 5 patients ( 4.5 % ) .
RESULTS	In the remaining 95.5 % , only minor correction was performed .
RESULTS	Mean manual annulus area was significantly smaller than fully automated results ( P < .001 for both readers ) but similar to semiautomated measurements ( 5.0 vs 5.4 vs 4.9 cm ( 2 ) , respectively ) .
RESULTS	The frequency of concordant recommendations for valve size increased if manual analysis was replaced with the semiautomated method ( 60 % agreement was improved to 82.4 % ; 95 % confidence interval for the difference [ 69.1 % -83.4 % ] ) .
CONCLUSIONS	Semiautomated aortic annulus analysis , with minor correction by the user , provides reliable results in the context of TAVR annulus evaluation .

###24755566
BACKGROUND	Chronic low-back pain ( cLBP ) is a common condition throughout the world , and acupuncture is widely sought for treatment .
BACKGROUND	As clinical evidence for the benefits of acupuncture grows , acupuncture for cLBP is receiving increased recognition and acceptance by both patients and professionals .
BACKGROUND	Time method acupuncture has been previously researched with respect to chronic gastritis .
OBJECTIVE	For individuals with cLBP in the current study , the research team examined the efficacy of adding confluent acupoints , related to the daytime period in time method acupuncture , to regular acupuncture and also evaluated the persistence of the benefits of such acupuncture in comparison with regular acupuncture .
METHODS	The study was a randomized , controlled trial ( RCT ) .
METHODS	The setting was an outpatient clinic of the Dongzhimen Hospital in Beijing , China .
METHODS	Participants were Chinese men and women with cLBP .
METHODS	Sixty participants were randomly divided into 2 groups to receive acupuncture .
METHODS	The control group received a treatment that followed a routine acupuncture ( RA ) protocol , while the intervention group received a treatment that followed an RA protocol plus acupuncture in confluent points related to time ( TA ) .
METHODS	The research team measured the change in participants ' scores using the visual analogue scale ( VAS ) , the number of therapy sessions needed , the number of days that participants were absent from work during the treatment period and at 12 wk posttreatment , and the number of pain relapses between the end of treatment and the 4 - and 12-wk follow-ups .
RESULTS	VAS scores decreased from 69.6 7.9 to 11.8 4.9 in the intervention group compared with a decrease from 69.2 8.0 to 15.7 10.0 in the control group ( P = .001 ) .
RESULTS	The intervention group received fewer therapy sessions ( 8.1 2.0 ) than did the control group ( 10.1 2.0 , P < .001 ) .
RESULTS	Compared with the controls , the intervention group showed fewer days absent from work ( 0.5 vs 1.4 ; P = .03 ) and fewer pain relapses ( 4.0 vs 7.0 ; P = .04 ) at the 12-wk follow-up .
RESULTS	In the 2 groups combined , VAS decreased from 69.4 7.9 before the first session of acupuncture to 13.8 8.0 after the last session ( P < .001 ) , and the number of therapy sessions needed for pain relief was 9.1 2.2 .
CONCLUSIONS	Accompanying routine acupuncture with time method acupuncture can enhance the efficacy of treatment and the persistence of its benefits in individuals with cLBP .

###24599566
OBJECTIVE	To evaluate the effect of a protocol of local anesthesia and epinephrine associated with sedo-analgesia on post-TVT-O pain in comparison with infiltration of saline and epinephrine .
METHODS	Forty-two patients undergoing TVT-O were randomized into two groups to receive periurethral infiltration with epinephrine only ( group A , n = 21 ) or with epinephrine plus 1 % lidocaine hydrochloride ( group B , n = 21 ) .
METHODS	Post-operative pain was assessed using a visual analog scale ( VAS ) from 0 ( absence of pain ) to 10 ( maximum pain possible ) , 1 , 6 , 12 and 24 h after the procedure .
METHODS	The total amount of analgesia was recorded and the proportion of women reporting a pain VAS score 4 , 1 h after the procedure was calculated .
METHODS	ANOVA for repeated measures and Bonferroni correction , the Student 's t test for independent samples , the Mann-Whitney U test , the Fisher exact test , or the ( 2 ) test for parametric was used .
RESULTS	Pain level was significantly lower in group B 1 ( p = 0.01 ) and 6 h ( p = 0.05 ) after surgery , but not 12 and 24 h after the procedure .
RESULTS	No significant difference was observed in the proportion of women requesting analgesia and in the total dosage of analgesics between the two groups .
RESULTS	A significant higher proportion of women in group A reported a pain VAS score higher than four 1 h after surgery in comparison with patients in group B.
CONCLUSIONS	This randomized study seems to indicate that systematic infiltration before TVT-O positioning with local anesthetic may reduce immediate post-operative pain .

###24274342
BACKGROUND	Therapeutic hypothermia ( TH , 32-34C ) has been shown to improve neurological outcome in comatose survivors of out-of-hospital cardiac arrest ( OHCA ) with ventricular tachycardia or fibrillation .
BACKGROUND	Earlier initiation of TH may increase the beneficial effects .
BACKGROUND	Experimental studies have suggested that starting TH during cardiopulmonary resuscitation ( CPR ) may further enhance its neuroprotective effects .
BACKGROUND	The aim of this study was to evaluate whether intra-arrest TH ( IATH ) , initiated in the field with trans nasal evaporative cooling ( TNEC ) , would provide outcome benefits when compared to standard of care in patients being resuscitated from OHCA .
METHODS	We describe the methodology of a multi-centre , randomized , controlled trial comparing IATH delivered through TNEC device ( Rhinochill , Benechill Inc. , San Diego , CA , USA ) during CPR to standard treatment , including TH initiated after hospital admission .
METHODS	The primary outcome is neurological intact survival defined as cerebral performance category 1-2 at 90days among those patients who are admitted to the hospital .
METHODS	Secondary outcomes include survival at 90days , proportion of patients achieving a return to spontaneous circulation ( ROSC ) , the proportion of patients admitted alive to the hospital and the proportion of patients achieving target temperature ( < 34C ) within the first 4hours since CA .
CONCLUSIONS	This ongoing trial will assess the impact of IATH with TNEC , which may be able to rapidly induce brain cooling and have fewer side effects than other methods , such as cold fluid infusion .
CONCLUSIONS	If this intervention is found to improve neurological outcome , its early use in the pre-hospital setting will be considered as an early neuro-protective strategy in OHCA .
BACKGROUND	NCT01400373 .

###25467394
BACKGROUND	Body weight-supported treadmill training ( BWSTT ) has produced mixed results compared with other therapeutic techniques .
OBJECTIVE	The purpose of this study was to determine whether an intensive intervention ( intensive mobility training ) including BWSTT provides superior gait , balance , and mobility outcomes compared with a similar intervention with overground gait training in place of BWSTT .
METHODS	Forty-three individuals with chronic stroke ( mean [ SD ] age , 61.5 [ 13.5 ] years ; mean [ SD ] time since stroke , 3.3 [ 3.8 ] years ) , were randomized to a treatment ( BWSTT , n = 23 ) or control ( overground gait training , n = 20 ) group .
METHODS	Treatment consisted of 1 hour of gait training ; 1 hour of balance activities ; and 1 hour of strength , range of motion , and coordination for 10 consecutive weekdays ( 30 hours ) .
METHODS	Assessments ( step length differential , self-selected and fast walking speed , 6-minute walk test , Berg Balance Scale [ BBS ] , Dynamic Gait Index [ DGI ] , Activities-specific Balance Confidence [ ABC ] scale , single limb stance , Timed Up and Go [ TUG ] , Fugl-Meyer [ FM ] , and perceived recovery [ PR ] ) were conducted before , immediately after , and 3 months after intervention .
RESULTS	No significant differences ( = 0.05 ) were found between groups after training or at follow-up ; therefore , groups were combined for remaining analyses .
RESULTS	Significant differences ( = 0.05 ) were found pretest to posttest for fast walking speed , BBS , DGI , ABC , TUG , FM , and PR .
RESULTS	DGI , ABC , TUG , and PR results remained significant at follow-up .
RESULTS	Effect sizes were small to moderate in the direction of improvement .
CONCLUSIONS	Future studies should investigate the effectiveness of intensive interventions of durations greater than 10 days for improving gait , balance , and mobility in individuals with chronic stroke .

###24608624
OBJECTIVE	The aim of this study was to evaluate the clinical benefit of valacyclovir when performing full-mouth periodontal debridement in patients with advanced chronic periodontitis .
METHODS	Fifty-nine patients with advanced chronic periodontitis were randomly assigned into control-treatment group ( n = 29 ) and intensive-treatment group ( n = 30 ) .
METHODS	All patients were given instructions of basic oral hygiene and a standard cycle of supragingival mechanical scaling and polishing .
METHODS	Patients in the intensive-treatment group received oral valacyclovir for 1 week , while patients in the control-treatment group received placebo .
METHODS	Thereafter , patients in both groups underwent full-mouth intensive removal of subgingival dental plaque biofilms with the use of scaling and root planing within 48 hours .
METHODS	Periodontal parameters were evaluated before treatment and 2 or 6 months after treatment .
METHODS	The data was statistically analyzed using SPSS17 .0 software package .
RESULTS	No significant difference in clinical parameters was noted before treatment .
RESULTS	2 and 6 months after treatment , the mean percentage reduction of sites with BOP and PD4 mm were significantly higher in the intensive-treatment group than in the control-treatment group ( P < 0.05 ) .
RESULTS	Similarly , patients in the intensive-treatment group had higher mean PD reduction than those in the control-treatment group 2 months ( P < 0.05 ) and 6 months after therapy ( P < 0.05 ) .
RESULTS	However , the mean values of CAL reduction were slightly and not significantly higher in the intensive-treatment group than in the control-treatment group after therapy .
CONCLUSIONS	It may be concluded that valacyclovir significantly improves clinical results of full-mouth non-surgical periodontal debridement in advanced chronic periodontitis .

###24356937
OBJECTIVE	Heart rate was proposed as an emergent cardiovascular ( CV ) risk factor .
OBJECTIVE	Previous studies have shown associations between increased heart rate and CV risk in various populations .
OBJECTIVE	We aimed to evaluate the prognostic relevance of heart rate in a large contemporaneous medically optimized cohort of patients with stable chronic CV disease .
RESULTS	In a post hoc analysis of the ONTARGET/TRANSCEND trials , we evaluated associations between baseline and average heart rate in trial with CV risk in 31 , 531 patients followed for a median of 5 years .
RESULTS	The primary outcome , major vascular events ( MVE ) , was a composite of CV death , myocardial infarction ( MI ) , stroke , and congestive heart failure ( CHF ) .
RESULTS	Pre-specified secondary outcomes included all-cause death and the individual components of the primary outcome .
RESULTS	Associations between heart rate and outcomes were computed with heart rate as a continuous variable , baseline heart rate > 70 vs 70 bpm , and across heart rate quintiles , adjusting for other markers of risk , beta-blocker and non-dihydropyridine calcium channel blocker use .
RESULTS	For each 10 bpm increase in baseline and average heart rate , we observed a significant increase in risk of MVE , CV death , CHF and all-cause death .
RESULTS	There was a continuous relationship between MVE and baseline and , more importantly , average in-trial heart rate , with no observed threshold .
RESULTS	MVE , CV death , stroke , CHF , and all-cause death increased across heart rate quintiles .
RESULTS	There was no association between MI and HR .
RESULTS	Results were consistent in clinically relevant subgroups .
RESULTS	There were modest but significant improvements in C-statistic and in statistical measures of model calibration for models that included heart rate for MVE , CV death , CHF and all-cause death .
CONCLUSIONS	This large study examined and quantitated associations between heart rate and CV events in a contemporary medically optimized population with stable CV disease .
CONCLUSIONS	Resting and , in particular , in-trial average heart rate are independently associated with significant increases in CV events and all-cause death .

###26442396
OBJECTIVE	Lumbar laminectomy is a commonly performed procedure in neurosurgical and orthopedic practice .
OBJECTIVE	Postoperative pain reliefhelps in early mobilization , initiation of physiotherapy , provides satisfaction to the patients and plays an important role in reducing the morbidity and mortality .
OBJECTIVE	This prospective study investigated the simple technique of instillation of wound with bupivacaine and leaving a contact time of 60 seconds on postoperative pain following lumbar laminectomy .
METHODS	32 ASA I and II patients scheduled for laminectomy were randomly allocated to receive either 20 ml of normal saline ( group I ) or 0.25 % of bupivacaine ( group II ) into the wound after securing hemostasis .
METHODS	After a dwell time of 60sec the wound was closed in layers without mopping or suctioning .
METHODS	After extubation , the pain scores were evaluated by visual analog scale at every 4 hrs .
METHODS	for 24hrs and also the time for first demand of analgesia , number of analgesic demands and the total amount of analgesia consumed were noted by an independent observer .
RESULTS	The median duration of analgesia in group I was 8.8 [ 5-11 ] and in group II 13 [ 8.5-16 ] hrs .
RESULTS	with a p = 0.04 .
RESULTS	The number of demands and the amount of analgesia consumed was also statistically significant .
CONCLUSIONS	Wound instillation technique is simple , safe and effective in management of acute pain management after lumbar laminectomy and can be used as one among the multimodal armamentarium in pain management .

###24981503
BACKGROUND	The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program ( MAGDA-DPP ) is a randomized controlled trial ( RCT ) that aims to assess the effectiveness of a structured diabetes prevention intervention for women who had gestational diabetes .
METHODS	The original protocol was published in Trials ( http://www.trialsjournal.com/content/14/1/339 ) .
METHODS	This update reports on an additional exclusion criterion and change in first eligibility screening to provide greater clarity .
METHODS	The new exclusion criterion `` surgical or medical intervention to treat obesity '' has been added to the original protocol .
METHODS	The risks of developing diabetes will be affected by any medical or surgical intervention as its impact on obesity will alter the outcomes being assessed by MAGDA-DPP .
METHODS	The screening procedures have also been updated to reflect the current recruitment operation .
METHODS	The first eligibility screening is now taking place either during or after pregnancy , depending on recruitment strategy .
BACKGROUND	Australian New Zealand Clinical Trials Registry ANZCTRN 12610000338066 .

###24475799
OBJECTIVE	To compare prostatic arterial embolization ( PAE ) and transurethral resection of the prostate ( TURP ) in the care of patients with benign prostatic hyperplasia ( BPH ) .
METHODS	This prospective randomized clinical trial was approved by the institutional review board .
METHODS	A total of 114 patients provided written informed consent and were randomly assigned to undergo PAE ( n = 57 ) or TURP ( n = 57 ) .
METHODS	The groups were compared regarding relevant adverse events and complications .
METHODS	Functional results -- including improvement of International Prostate Symptom Score ( IPSS ) , quality of life ( QOL ) , peak urinary flow , postvoiding residual urine volume , prostate-specific antigen ( PSA ) level , and prostate volume -- were assessed at 1 - , 3 - , 6 - , 12 - , and 24-month follow-up between January 20 , 2007 , and January 31 , 2012 .
METHODS	Student t test , ( 2 ) test , Fisher exact test , and repeated measures analysis of variance were used , as appropriate .
RESULTS	Overall technical success rates for TURP and PAE were 100 % and 94.7 % , respectively ; the clinical failure rates were 3.9 % and 9.4 % , respectively .
RESULTS	The six functional results showed improvements after TURP and PAE at all follow-up time points when compared with preoperative values ( P = .001 ) .
RESULTS	However , the TURP group showed greater degrees of improvement in the IPSS , QOL , peak urinary flow , and postvoiding residual urine volume at 1 and 3 months , as well as greater reductions in the PSA level and prostate volume at all follow-up time points , when compared with the PAE group ( P < .05 ) .
RESULTS	The PAE group showed more overall adverse events and complications ( P = .029 ) , mostly related to acute urinary retention ( 25.9 % ) , postembolization syndrome ( 11.1 % ) , and treatment failures ( 5.3 % technical ; 9.4 % clinical ) .
CONCLUSIONS	Both procedures resulted in significant clinical improvements in the treatment of BPH .
CONCLUSIONS	However , the advantages of the PAE procedure must be weighed against the potential for technical and clinical failures in a minority of patients .

###24998293
BACKGROUND	The aim of this trial was to compare the effects of resistance training versus passive physical therapy on quality of life ( QoL ) , fatigue , and emotional distress outcomes during radiation therapy in patients with spinal bone metastases under radiotherapy ( RT ) .
METHODS	In this randomized trial , 60 patients were treated from September 2011 until March 2013 into one of the two groups : isometric resistance training or physical therapy with thirty patients in each group during RT. .
METHODS	EORTC QLQ-BM22 , EORTC QLQ-FA13 , and FBK-R10 were assessed at baseline , three months , and six months after RT. .
RESULTS	Psychosocial aspects in resistance training group ( Arm A ) were significantly improved after three ( p = 0.001 ) and six months ( p = 0.010 ) .
RESULTS	Other rated items of the QLQ-BM22 painful site , and pain characteristics were without significant differences .
RESULTS	Functional interference showed a positive trend after six months ( p = 0.081 ) .
RESULTS	After six months , physical fatigue ( p = 0.013 ) , and interference with daily life ( p = 0.006 ) according to the QLQ-FA13 assessment improved in Arm A significantly .
RESULTS	Emotional distress was in Arm A lower after six months ( p = 0.016 ) .
RESULTS	The Cohen 's effect size confirmed the clinically significant improvement of these findings .
CONCLUSIONS	In this group of patients we were able to show that guided isometric resistance training of the paravertebral muscles can improve functional capacity , reduce fatigue and thereby enhance QoL over a 6-months period in patients with stable spinal metastases .
CONCLUSIONS	The results offer a rationale for future large controlled investigations to confirm these findings .
BACKGROUND	Clinical trial identifier NCT01409720 .

###24918555
BACKGROUND	Isotretinoin-Lidose , the first new formulation of isotretinoin in 30 years , differs from previously approved isotretinoin formulations in that it is less dependent on the presence of fat in the gut for absorption .
OBJECTIVE	Evaluate the safety profiles of isotretinoin-Lidose and food-dependent generic isotretinoin in the largest clinical study with isotretinoin-925 randomized patients from 49 study sites .
OBJECTIVE	Determine if the efficacy of this new formulation is noninferior to an existing isotretinoin .
METHODS	Multicenter , double-blind , randomized , parallel-group , noninferiority trial .
METHODS	Study medication was taken with meals twice daily for 20 weeks .
METHODS	Patients were followed for 4 weeks after the last dose .
METHODS	Safety evaluations included recordings of adverse events , assessments for depression , anxiety , emergent psychotic symptoms , and suicidal ideation/behavior , as well as DEXA and X-ray evaluations and changes in bone age .
METHODS	Two co-primary efficacy outcomes were measured to assess noninferiority : a ) change in total nodular facial and truncal lesion count at from baseline to week 20 and b ) percentage of patients who experienced at least 90 % reduction in nodular facial and truncal lesion count from baseline to week 20 .
CONCLUSIONS	Although isotretinoin-Lidose can be taken without meals , it was given with food because the absorption of both formulations in the study had to be similar to detect noninferiority .
RESULTS	The safety profile of the 2 formulations was comparable .
RESULTS	Criteria for noninferiority for both co-primary efficacy outcomes were met based on predetermined margins .
CONCLUSIONS	Safety and efficacy of isotretinoin-Lidose is similar and noninferior to food-dependent generic isotretinoin , respectively .

###24290781
OBJECTIVE	To optimize contrast media ( CM ) injection protocols by individually tailoring the dose to the patient 's body weight ( BW ) , body mass index ( BMI ) and heart rate ( HR ) at dual-source computed tomography coronary angiography ( DSCT-CA ) .
METHODS	A total of 423 patients were prospectively enrolled and were randomly assigned to four groups .
METHODS	The control group received 80 ml CM at 5 ml/s .
METHODS	For the HR-optimized group , the injection duration was the same as the scan duration plus 8 s.
METHODS	In the Body-optimized group , the dose of CM was tailored to BW and BMI .
METHODS	In the HR + Body-optimized group , CM protocols tailored to body size and scan duration were applied .
METHODS	Individual variability of arterial attenuation and incidence of arterial over-opacification ( attenuation > 500 HU ) in the four groups were compared .
METHODS	Correlations between BW , BMI , HR , and arterial attenuations were evaluated in the four groups , respectively .
RESULTS	Reduced individual variability of arterial attenuation and a significantly lower incidence of arterial over-opacification were found in the Body-optimized group and HR + Body-optimized group .
RESULTS	Arterial attenuation was inversely correlated with BW , BMI , and HR in the control group , inversely correlated with BW and BMI in the HR-optimized group , and inversely correlated with HR in the Body-optimized group .
RESULTS	In the HR + Body-optimized group , arterial attenuation was not significantly correlated with BW , BMI , or HR respectively .
CONCLUSIONS	CM protocols individually tailored to BW , BMI , and HR can lead to reduced individual variability and a lower incidence of over-opacification of arterial attenuation , but also can reduce the influence of BW , BMI , and HR on arterial attenuations at DSCT-CA .

###24229669
BACKGROUND	The probability and risk of operations increase in patients with type 2 diabetes mellitus .
BACKGROUND	For diabetic patients , blood glucose control is a key factor to improving the prognosis of surgery .
BACKGROUND	During perioperative period , insulin therapy is usually advised to be used for surgical patients with type 2 diabetes .
BACKGROUND	However , the insulin regimen which one is better remains controversial .
BACKGROUND	In this study , we estimated the efficacy , safety and advantage of different insulin therapy strategy during perioperative period .
METHODS	A total of 1086 cases of surgical patients with type 2 diabetes mellitus enrolled in the present study .
METHODS	According to the glucose level at admission , all patients were divided into relatively high glucose group ( group A , fasting blood glucose ( FBG ) 13.9 mmol/L ) and higher glucose group ( group B , FBG > 13.9 mmol/L ) .
METHODS	Patients in group A randomly accepted premixed insulin twice a day , or basal insulin plus oral medications , and were divided into group A1 and A2 respectively .
METHODS	Patients in group B randomly received premixed insulin twice daily , basal insulin plus oral hypoglycemic agents , or basal insulin plus preprandial insulin , and were divided into group B1 , B2 and B3 respectively .
METHODS	The data of the preoperative preparation time , the daily doses of insulin used in different periods , postoperative incision healed installments , hypoglycemic events , the total hospitalization time , postoperative complications were all collected and statistically analyzed .
RESULTS	Compared the main outcome measures in groups treated by premixed insulin therapy , both in preoperative preparation and postoperative period , the daily insulin dosage and the frequency of hypoglycemic events were decreased in groups treated by basal insulin therapy ( P < 0.05 ) .
RESULTS	The preoperative preparation time and the total hospitalization time in groups with basal insulin therapy were shorter than that in groups with premixed insulin therapy ( P < 0.05 ) .
RESULTS	The incision healing rate of stage I , II and III among different therapy protocols were significantly different ( P < 0.05 ) .
CONCLUSIONS	Basal insulin therapy could be used in diabetic patients undergoing elective major and medium surgery during whole perioperative period .
CONCLUSIONS	Basal insulin therapy strategy , including a single injection of basal insulin and basal insulin plus preprandial insulin injection subcutaneously , is superior to premixed insulin therapy in the perioperative blood glucose management , and it could be viewed as the best choice in glucose control during perioperative period .

###25175176
BACKGROUND	Women have unfavorable prognosis after myocardial infarction ( MI ) .
BACKGROUND	This text describes sex differences in mortality and in the power of risk predictors in contemporarily-treated MI patients .
METHODS	A population of 4141 MI patients ( 26.5 % females ) was followed up for 5years .
METHODS	Effects of sex and age on total mortality were investigated by multivariable Cox analysis .
METHODS	Mortality predictors were investigated by receiver-operator characteristics analysis .
METHODS	Stepwise multivariable Cox regression was used to create sex-specific predictive models .
RESULTS	Thirty-day mortality was 1.5-fold higher in women .
RESULTS	However , sex was not a significant mortality predictor in a model adjusted for age .
RESULTS	Predictors for 5-year mortality performed differently in male and female patients .
RESULTS	In women , a sex-specific model provided better risk stratification than a sex-neutral model .
CONCLUSIONS	The unfavorable prognosis of female MI patients can be explained by advanced age .
CONCLUSIONS	Sex-specific predictive models might improve risk stratification in female survivors of acute MI .

###24579804
OBJECTIVE	The aim of this study was to compare the outcomes of dorsal onlay urethroplasty using buccal mucosa graft ( BMG ) versus penile skin flap ( PSF ) in the repair of long anterior urethral strictures .
METHODS	Patients with long anterior urethral strictures were randomized to receive either dorsal onlay BMG urethroplasty or PSF urethroplasty .
METHODS	All patients were evaluated preoperatively and during follow-up with the International Prostate Symptom Score ( IPSS ) and uroflowmetry .
METHODS	Success was reported when there were no obstructive symptoms on IPSS , with a peak urinary ow rate ( Qmax ) of at least 15 ml/s .
METHODS	Failure was reported in patients with obstructive symptoms , Qmax less than 15 ml/s and evidence of recurring stricture on urethrography .
RESULTS	The study included 19 and 18 patients in the BMG and PSF groups , respectively .
RESULTS	The mean operative time was significantly shorter in the BMG than in the PSF group .
RESULTS	The success rate was higher in the BMG than in the PSF group ( 89.5 % vs 83.3 % ) , but not statistically significant different .
RESULTS	The PSF group included one case of extensive skin loss , three cases with superficial skin necrosis and two with minor penile torsion .
RESULTS	In the BMG group , there were three cases of perioral numbness and another three had increased salivation .
RESULTS	The incidence of troublesome postvoid urinary dribbling was significantly higher in the PSF than in the BMG group .
RESULTS	After 6 months of urethroplasty , patient satisfaction was statistically significantly higher in the BMG than in the PSF group .
CONCLUSIONS	BMG and PSF dorsal onlay urethroplasty had similar success rates .
CONCLUSIONS	However , BMG is technically easier , takes less operative time and has a potential advantage in reducing postoperative morbidity , therefore leading to satisfaction for most patients .

###25666010
BACKGROUND	Pulpotomy is the common therapy for cariously exposed pulps in symptom-free primary molar teeth .
BACKGROUND	Formocresol ( FC ) is considered the gold standard dressing agent for pulpotomy , but concerns have been raised over the years about its safety .
BACKGROUND	Other alternative pulpotomy agents have been investigated and suggested .
OBJECTIVE	The objective was to evaluate and compare the clinical and radiographic response of FC and white mineral trioxide aggregate ( MTA ) as pulpotomy materials on primary molars .
METHODS	Fifty primary molars , with deep carious lesion that exposed a vital but asymptomatic pulp , in 37 children aged 4-7 years were treated with conventional pulpotomy procedure .
METHODS	The teeth were divided randomly into two groups .
METHODS	Group I ( FC ) and group II ( MTA ) .
METHODS	The treated teeth were evaluated clinically and radiographically and were followed-up for 12 months .
RESULTS	At the end of the 12 months follow-up , the clinical success rates for FC and MTA were 81 % and 100 % , respectively .
RESULTS	There was a statistically significant difference ( P = 0.04 ) between the clinical success rates of FC and MTA .
RESULTS	While the radiographic success rates for FC and MTA were 81 % and 96 % , respectively , there was no statistically significant difference between the radiographic success of MTA and FC .
CONCLUSIONS	White MTA showed a higher clinical and radiographic success rate when compared to FC as a pulpotomy agent in vital primary molars , and it has a potential to become a replacement for FC in primary molars .

###24738695
OBJECTIVE	Diabetic nephropathy ( DN ) is a serious and common complication of diabetes mellitus leading to end-stage renal disease in up to 30 % of diabetic patients .
OBJECTIVE	The first manifestation of DN in humans is microalbuminuria , which arises from the increased passage of albumin through the glomerular filtration barrier .
OBJECTIVE	Reactive oxygen species , inflammatory cytokines , and growth factors are key players in the context of damage to the glomerular filtration barrier .
METHODS	In this study the herbal combination Canephron ( ) N , containing lovage root , rosemary leaves , and centaury herb , was administered to patients with DN to study the effects on microalbuminuria and overall oxidant/antioxidant status .
METHODS	An open study involving 59 patients with DN was performed to compare the effects of Canephron N administered concomitantly with standard antidiabetic therapy and an angiotensin-converting enzyme ( ACE ) inhibitor , with the standard therapy and ACE inhibitor treatment alone .
RESULTS	After 6 months of therapy the level of microalbuminuria decreased significantly in the study group compared with the control group .
RESULTS	Canephron N had a positive effect on the antioxidant defense status and lipid peroxidation levels .
RESULTS	In addition , liver aminotransferase levels did not change .
CONCLUSIONS	With respect to the excellent tolerability , the study results encourage use of the herbal combination as an add-on therapy in patients with DN .

###25459040
OBJECTIVE	The aim of this study was to assess the feasibility of hybrid coronary revascularization ( HCR ) in patientswith multivessel coronary artery disease ( MVCAD ) referred for standard coronary artery bypass grafting ( CABG ) .
BACKGROUND	Conventional CABG is still the treatment of choice in patients with MVCAD .
BACKGROUND	However , the limitations of standard CABG and the unsatisfactory long-term patency of saphenous grafts are commonly known .
METHODS	A total of 200 patients with MVCAD involving the left anterior descending artery ( LAD ) and a critical ( > 70 % ) lesion in at least 1 major epicardial vessel ( except the LAD ) amenable to both PCI and CABG and referred for conventional surgical revascularization were randomly assigned to undergo HCR or CABG ( in a 1:1 ratio ) .
METHODS	The primary endpoint was the evaluation of the safety of HCR .
METHODS	The feasibility was defined by the percent of patients with a completeHCR procedure and the percent of patients with conversions to standard CABG .
METHODS	The occurrence of major adverse cardiac events such as death , myocardial infarction , stroke , repeated revascularization , and major bleeding within the 12-month period after randomization was also assessed .
RESULTS	Most of the pre-procedural characteristics were similar in the 2 groups .
RESULTS	Of the patients in the hybrid group , 93.9 % had complete HCR and 6.1 % patients were converted to standard CABG .
RESULTS	At 12 months , the rates of death ( 2.0 % vs. 2.9 % , p = NS ) , myocardial infarction ( 6.1 % vs. 3.9 % , p = NS ) , major bleeding ( 2 % vs. 2 % , p = NS ) , and repeat revascularization ( 2 % vs. 0 % , p = NS ) were similar in the 2 groups .
RESULTS	In both groups , no cerebrovascular incidents were observed .
CONCLUSIONS	HCR is feasible in select patients with MVCAD referred for conventional CABG .
CONCLUSIONS	( Safety and Efficacy Study of Hybrid Revascularization in Multivessel Coronary Artery Disease [ POL-MIDES ] ; NCT01035567 ) .

###24357798
BACKGROUND	In this study , we sought to identify a criterion for the intermediate-risk grouping of patients with cervical cancer who exhibit any intermediate-risk factor after radical hysterectomy .
METHODS	In total , 2158 patients with pathologically proven stage IB-IIA cervical cancer with any intermediate-risk factor after radical hysterectomy were randomly assigned to two groups , a development group and a validation group , at a ratio of 3:1 ( 1620 patients :538 patients ) .
METHODS	To predict recurrence , multivariate models were developed using the development group .
METHODS	The ability of the models to discriminate between groups was validated using the log-rank test and receiver operating characteristic ( ROC ) analysis .
RESULTS	Four factors ( histology , tumour size , deep stromal invasion ( DSI ) , and lymphovascular space involvement ( LVSI ) ) were significantly associated with disease recurrence and included in the models .
RESULTS	Among the nine possible combinations of the four variables , models consisting of any two of the four intermediate-risk factors ( tumour size 3cm , DSI of the outer third of the cervix , LVSI , and adenocarcinoma or adenosquamous carcinoma histology ) demonstrated the best performance for predicting recurrence .
CONCLUSIONS	This study identified a ` four-factor model ' in which the presence of any two factors may be useful for predicting recurrence in patients with cervical cancer treated with radical hysterectomy .

###25070400
BACKGROUND	In order to meet the patients wish for compensation of presbyopia in a flexible way , even in cases of an already pseudophacic eye , sulcus-fixated additional intraocular lenses ( IOL ) have been developed as an alternative to multifocal IOLs ( MIOL ) in the capsular bag .
BACKGROUND	This allows subsequent application of multifocal optics .
BACKGROUND	Furthermore , these additional lenses offer a relatively simple opportunity for postoperative refractive fine tuning or , in cases of incompatibility , a minimally invasive explantation of the multifocal part of the optical system .
OBJECTIVE	The objective of our work was the examination of a diffractive multifocal additional IOL and its functional characteristics .
METHODS	In a prospective , monocentric trial 32 eyes of 21 patients had cataract surgery with implantation of a monofocal IOL into the capsular bag and simultaneous implantation of a multifocal additional IOL into the sulcus .
METHODS	The visual acuity was tested at different distances 6 weeks and 3 months postoperatively .
METHODS	At the 3 month follow-up contrast sensitivity and defocus curves were additionally assessed .
METHODS	Patients with bilateral implantation filled in a questionnaire to assess their subjective satisfaction of postoperative visual quality .
RESULTS	All eyes had an uneventful postoperative course .
RESULTS	At both follow-ups an uncorrected distance and near visual acuity ( VA ) of 0.2 LogMAR or better was achieved .
RESULTS	In intermediate vision 29 out of 32 eyes after 6 weeks and 31 out of 32 eyes after 3 months reached an uncorrected VA of 0.2 LogMAR or better .
RESULTS	The defocus curves showed a typical two-peaked shape .
RESULTS	At intermediate distance ( -1.5 D of defocus ) the median VA was 0.35 LogMAR .
RESULTS	Contrast sensitivity testing showed results in the upper region of the standard range of age-matched , healthy patients .
CONCLUSIONS	The examined type of diffractive additional IOL achieved good to very good functional results , which are comparable to corresponding IOLs in the capsular bag .
CONCLUSIONS	Multifocal additional IOLs can be considered as a useful extension of refractive surgical alternatives for the compensation of presbyopia .
CONCLUSIONS	The possibility to implant the multifocal optic part independently of the primary surgery , the minimal invasivity of the procedure and the likewise time-independent reversibility can be pointed out as special qualities of these IOL .

###24697877
OBJECTIVE	Clinical trials suggest that statins have beneficial effects on the cardiovascular system independent from their cholesterol lowering properties .
OBJECTIVE	In patients with chronic kidney disease stage II-III , we tested the hypothesis that atorvastatin increased systemic and renal nitric oxide ( NO ) availability using L-N ( G ) - monomethyl arginine ( L-NMMA ) as an inhibitor of NO production .
METHODS	In a randomized , placebo-controlled , crossover study patients were treated with atorvastatin for 5 days with standardized diet and fluid intake .
METHODS	Glomerular filtration reate ( GFR ) , fractional excretions of sodium ( FENa ) , urinary excretion of aquaporin-2 ( u-AQP2 ) and epithelial sodium channels ( u-ENaC ) , vasoactive hormones ( renin , angiotensin II , aldosterone , arginine vasopressin , endothelin-1 and brain natriuretic peptide ) and central blood pressure ( BP ) estimated by applanation tonometry were measured before and after systemic administration of the NO inhibitor L-NMMA .
RESULTS	Atorvastatin caused a significant reduction in U-ENaC , but sodium excretion , C H 2 O , FENa and u-AQP2 were not changed by atorvastatin .
RESULTS	L-NMMA reduced renal effect variables , including GFR , FENa and u-ENaC and increased brachial BP and central BP to a similar extent during both treatments .
RESULTS	Vasoactive hormones were changed in the same way by L-NMMA during atorvastatin and placebo treatment .
CONCLUSIONS	During , atorvastatin and placebo treatment , inhibition of nitric oxide synthesis induced the same response in brachial and central blood pressure , GFR , renal tubular function and vasoactive hormones .
CONCLUSIONS	Thus , the data do not support that atorvastatin changes nitric oxide availability in patients with mild nephropathy .
CONCLUSIONS	The reduced u-ENaC may reflect changes in sodium absorption in the nephron induced by atorvastatin .

###24755056
OBJECTIVE	The aim of the study is to present a comparison of short-term results of double - versus single-bundle anatomical reconstruction of the anterior cruciate ligament ( ACL ) using hamstring endons and their fixation with absorbable interference screws .
METHODS	A total of 110 patients with an isolated ACL lesion and the healthy contralateral knee who met the indication criteria for ACL double bundle reconstruction ( TISL , 14 mm ; ICNW , 12 mm ) were intra-operatively allocated at random to either double-bundle group ( DB , n = 55 ) or single-bundle group ( SB , n = 55 ) .
METHODS	At 12 months after surgery , 97 patients ( DB group , n = 49 ; SB group , n = 48 ) , comprising 68 men and 29 women , were evaluated ; the average age was 29.1 years and the injury-to-surgery interval was 15.9 weeks .
METHODS	Pre - and post-operative subjective criteria involved the IKDC and Lysholm score .
METHODS	Objectively , the occurrence of graft failure , range of motion deficit , return to pre-injury sports activity , side-to-side difference in anterior laxity of both knees in 20 flexion on a GNRB laximeter at an applied pressure of 124 N and 250 N , and pivot shift phenomenon were assessed .
RESULTS	No statistically significant difference was found in pre-operative values between the two groups .
RESULTS	Post-operatively , there were no significant differences in the occurrence of complete graft failure ( p = 0.0755 ; DB group , n = 0 ; SB group , n = 3 ) , range-of-motion deficit ( p = 0.2277-0 .9788 ) or return to pre-operative sports activity ( p = 0.2322 ) .
RESULTS	In the DB group , side-to-side anterior tibial shifts at a pressure of 124 N ( medians = 1.3 mm and 2.1 mm for DB and SB groups , respectively ; p = 0.0007 ) and at a pressure of 250 N ( DB group = 2.1 mm ; SB group = 3.1 mm ; p < 0.0001 ) were significantly different from the corresponding values in the SB group .
RESULTS	Positive results for the pivot shift test ( PST ) were significantly less frequent in the DB than the SB group ( Chi-square test = 0.0112 ) .
RESULTS	The SB group patients had a 2.9-times ( odds ratio , 2.8704 ) higher risk of positive postoperative PST results than the DB group patients .
RESULTS	In both groups , a comparison of pre - and post-operative criteria showed significant improvement in both the subjective and the objective results .
CONCLUSIONS	The results of this study , in accordance with other authors ' conclusions , suggest that the double-bundle technique provides better control over rotational and anterior knee laxity and therefore restores knee biomechanics better .
CONCLUSIONS	However , other literature data do not confirm any significantly better outcomes of this method .
CONCLUSIONS	Since only short-term results have been obtained so far , the study will continue because only the long-term results can provide conclusive evidence of an advantage of one technique over the other .
CONCLUSIONS	Our study showed significantly better restoration of knee rotational and anterior laxity in the patients undergoing anatomical reconstruction of the ACL by the double-bundle technique .
CONCLUSIONS	The other evaluated criteria did not differ in relation to the technique used .

###25343945
BACKGROUND	Increased blood pressure ( BP ) is commonly observed in patients treated with vascular endothelial growth factor pathway inhibitors , including axitinib .
BACKGROUND	Ambulatory BP monitoring ( ABPM ) and pharmacokinetic data were collected in a randomised , double-blind phase II study of axitinib with or without dose titration in previously untreated patients with metastatic renal cell carcinoma .
OBJECTIVE	Aims of these analyses were to ( 1 ) develop a population pharmacokinetic-pharmacodynamic model for describing the relationship between axitinib exposure and changes in diastolic BP ( dBP ) and ( 2 ) simulate changes in dBP with different axitinib dosing regimens .
METHODS	We employed a three-stage modelling approach , which included development of ( 1 ) a baseline 24-h ABPM model , ( 2 ) a pharmacokinetic model from serial and sparse pharmacokinetic data , and ( 3 ) an indirect-response , maximum-effect ( Emax ) model to evaluate the exposure-driven effect of axitinib on dBP .
METHODS	Simulations ( N = 1,000 ) were performed using the final pharmacokinetic-pharmacodynamic model to evaluate dBP changes on days 4 and 15 of treatment with different axitinib doses .
RESULTS	Baseline ABPM data from 62 patients were best described by 24-h mean dBP and two cosine terms .
RESULTS	The final indirect-response Emax model showed good agreement between observed 24-h ABPM data and population and individual predictions .
RESULTS	The maximum increase in dBP was 20.8 % , and the axitinib concentration at which 50 % of the maximal increase in dBP was reached was 12.4 ng/mL .
CONCLUSIONS	Our model adequately describes the relationship between axitinib exposure and dBP increases .
CONCLUSIONS	Results from these analyses may potentially be applied to infer dBP changes in patients administered axitinib at nonstandard doses .

###26200232
OBJECTIVE	To compare risk-adjusted differences between men and women 30 and 60 days after hip fracture surgery in not walking , ability to return home in a community-dwelling subset , not walking in a nursing home resident subset , and mortality within 60 days .
METHODS	Cohort study .
METHODS	Data were from a randomized clinical trial that compared two blood transfusion protocols after hip fracture .
METHODS	Individuals with hip fracture ( N = 2,016 ; 489 ( 24 % ) male ) .
METHODS	Walking , dwelling , and mortality were determined in telephone follow-up 30 and 60 days after randomization , which occurred within 3 days of surgery .
METHODS	Sex differences for each outcome were compared using univariate and multivariate regression adjusting for potential confounders .
RESULTS	Men were younger ( P < .001 ) and more likely to have comorbidity ( P = .003 ) than women at the time of hip fracture and to die within 60 days , even after risk adjustment ( odds ratio ( OR ) = 1.76 , 95 % confidence interval ( CI ) = 1.15-2 .69 ) .
RESULTS	After risk adjustment , male survivors were as likely as female survivors not to walk ( OR = 1.03 , 95 % CI = 0.78-1 .34 ) and no less likely to return home ( OR = 0.90 , 95 % CI = 0.69-1 .17 ) 60 days after hip fracture .
RESULTS	No differences were noted between male and female nursing home residents in not walking within 60 days ( OR = 0.95 , 95 % CI = 0.32-2 .86 ) .
CONCLUSIONS	Although men experience higher mortality , male survivors can expect recovery of walking ability similar to that of female survivors and are as likely to return to community living .

###25539512
BACKGROUND	A single subanesthetic infusion of the N-methyl-D-aspartate ( NMDA ) receptor antagonist ketamine has rapid and potent antidepressant properties in treatment-resistant major depressive disorder ( TRD ) .
BACKGROUND	As a family history of an alcohol use disorder is a positive predictor of ketamine 's antidepressant response and the strength of the association increases over time , we hypothesized that depressed subjects with a family history of an alcohol use disorder would have greater antidepressant durability and that riluzole would augment and/or extend ketamine 's antidepressant efficacy .
METHODS	Fifty-two TRD subjects received an open-label infusion of ketamine ( 0.5 mg/kg over 40 minutes ) , and , four to six hours post-infusion , were randomized to either flexible-dose ( 100-200mg / day ) riluzole or placebo in the following proportions : Family History Positive ( FHP ) riluzole ( n = 10 ) , FHP placebo ( n = 9 ) , Family History Negative ( FHN ) riluzole ( n = 16 ) , and FHN placebo ( n = 17 ) .
RESULTS	FHP subjects randomized to placebo had a greater antidepressant response than FHN subjects ; however , contrary to our initial hypothesis , there was no significant difference in antidepressant efficacy with riluzole .
RESULTS	Although potentially underpowered , there was no difference in overall time-to-relapse based on randomization status ( riluzole responders : n = 15 , placebo responders : n = 17 ) .
RESULTS	Yet , time-to-relapse was longer in FHP placebo responders ( n = 8 ) compared to FHN placebo responders ( n = 9 ) with , again , no significant difference in time-to-relapse in FHP riluzole responders ( n = 6 ) compared to FHN riluzole responders ( n = 9 ) .
CONCLUSIONS	Ketamine 's extended antidepressant durability in FHP TRD should be considered in the design and analysis of ketamine depression trials .

###24445089
OBJECTIVE	To investigate the effect of combination therapy of backward walking training and alpha-lipoic acid ( ALA ) treatment on the distribution of plantar pressure in patients with diabetic peripheral neuropathy ( DPN ) .
METHODS	This study is a double-blinded , randomized controlled trial .
METHODS	The test group was treated with combination therapy of backward walking exercise and ALA ( ALA for 2wk , backward walking exercise for 12wk ) , and the control group only received ALA treatment .
METHODS	Clinical and laboratory setting .
METHODS	Patients with DPN ( N = 60 ) were divided into the test group ( n = 30 ) or control group ( n = 30 ) .
METHODS	Backward walking exercise with ALA treatment for the test group ; lipoic acid treatment for the control group .
METHODS	Plantar pressure before and after treatment was tested and analyzed with the flatbed plantar pressure measurement system .
RESULTS	After treatment , peak plantar pressure in the forefoot dropped for both the test and control groups ; peak plantar pressure for the test group dropped significantly .
RESULTS	Peak plantar pressure in the medial foot slightly increased for the test group , suggesting a more even distribution of plantar pressure in the test group after treatment .
CONCLUSIONS	The combination therapy of ALA and backward walking proved to be more effective than ALA monotherapy .
CONCLUSIONS	Backward walking also proved to have an ameliorating effect on balance ability and muscle strength of patients with DPN .

###24752228
OBJECTIVE	Hypertrophic resistance exercise ( HRE ) induces central and peripheral fatigue .
OBJECTIVE	However , more detailed information about changes in corticospinal excitability remains to be elucidated .
METHODS	Eleven volunteers participated in the upper arm HRE which included one repetition maximum ( 1 RM ) control contractions and three sets of 13 RM ( SET1-3 ) .
METHODS	Transcranial magnetic stimulation ( TMS ) was applied during maximal isometric voluntary contraction ( MVC ) at the end of each set and during control contractions to study changes in corticospinal excitability .
METHODS	Electrical stimulation was used in order to measure peripheral changes .
RESULTS	MVC decreased after each set when compared to control contractions .
RESULTS	Motor evoked potential ( MEP ) were 138.752.7 % ( p < 0.05 ) , 130.444.7 and 113.131.4 % after SET1 , SET2 and SET3 , respectively , when compared to pre-exercise value .
RESULTS	A significant reduction in MEP area between SET1 and SET3 ( p < 0.05 ) was observed while silent period ( SP ) duration increased ( ~ 151-165ms , p < 0.05 ) simultaneously between these sets .
RESULTS	TMS-evoked twitch force during MVC increased significantly following each set when compared to pre-exercise value .
RESULTS	Simultaneously , a significant reduction was observed in resting twitch force over the sets .
CONCLUSIONS	The results of this study clearly support the existence of both central and peripheral fatigue during HRE of elbow flexors .
CONCLUSIONS	However , changes in the MEP area and SP suggest that during HRE of the elbow flexors , the corticospinal excitability increases first , until at some point , supraspinal fatigue takes over .

###25770879
BACKGROUND	Actinic keratosis therapy can elicit unsightly and painful local skin responses ; assessment of treatment satisfaction and health-related quality of life ( QoL ) is important .
BACKGROUND	Ingenol mebutate gel is a novel topical field therapy for actinic keratosis .
OBJECTIVE	Post-hoc analyses were performed based on patient-reported outcomes from phase-III trials ( n = 1005 ) to assess the effects of ingenol mebutate on QoL and the relationship between both QoL and treatment satisfaction , and degree of lesion clearance .
METHODS	Patients received ingenol mebutate or vehicle for self-application to a 25-cm ( 2 ) contiguous area : 0.015 % once daily for 3 consecutive days ( face/scalp ) or 0.05 % once daily for 2 consecutive days ( trunk/extremities ) .
METHODS	QoL ( Skindex-16 ) and Treatment Satisfaction Questionnaire for Medication data were recorded .
RESULTS	Significant , positive associations between Treatment Satisfaction Questionnaire for Medication score and degree of clearance were identified for patients in the face/scalp ( effectiveness P < .0001 and global satisfaction P = .0002 ) and trunk/extremities ( P < .0001 and P = .0014 , respectively ) groups .
RESULTS	There was a significant association between Skindex-16 score and clearance for patients in the face/scalp group for change in symptoms ( P = .0218 ) , emotions ( P = .0002 ) , and overall Skindex-16 score ( P = .0006 ) from baseline .
CONCLUSIONS	Clinical trial population findings may not be generalizable to clinical practice .
CONCLUSIONS	Ingenol mebutate significantly improved patients ' QoL and treatment satisfaction .
CONCLUSIONS	Improvements were associated with higher degrees of actinic keratosis lesion clearance .

###24944140
BACKGROUND	Left ventricular ( LV ) twist may be a compensatory mechanism to preserve ejection fraction ( EF ) .
BACKGROUND	In patients with hypertension , twist varies depending on the left ventricle 's degree of remodeling and systolic function ; it is increased in those with hypertension with normal EF ( HTNEF ) and diminished in those with hypertension with low EF ( HTLEF ) .
BACKGROUND	The ratio of collagen-degradation biomarkers in patients with hypertension is higher in those with low EFs than those with preserved EFs and may contribute to remodeling and systolic dysfunction .
METHODS	The aim of this study was to evaluate the relationship between these biomarkers and LV twist in 82 patients with hypertension , 41 with EFs < 50 % ( HTLEF group ) and 41 with EFs 50 % ( HTNEF group ) .
METHODS	Net LV twist was measured using speckle-tracking echocardiography .
METHODS	Markers of collagen turnover , including serum concentrations of matrix metalloproteinase-1 ( MMP1 ) , tissue inhibitor of MMP1 ( TIMP1 ) , and the ratio of MMP1 to TIMP1 , were measured .
RESULTS	Log TIMP1 , log MMP1 , and log MMP1/TIMP1 ratio levels were higher in the HTLEF group than the HTNEF group ( 12.3 0.3 vs 11.8 0.1 [ P < .0001 ] , 9.1 0.3 vs 8.0 0.2 [ P < .0001 ] , and -3.3 0.3 vs -3.8 0.2 [ P < .0001 ] , respectively ) .
RESULTS	Net LV twist was lower in the HTLEF group than the HTNEF group ( 3.3 1.1 vs 11.7 0.7 , P < .0001 ) .
RESULTS	An inverse correlation existed between log MMP1/TIMP1 and net LV twist after adjusting for age , EF , duration of heart failure , systolic blood pressure , LV mass index , and LV sphericity index at end-diastole ( r = -0.43 , P < .0001 ) .
CONCLUSIONS	This inverse correlation between twist and loss of myocardial collagen scaffolding in patients with hypertension with heart failure suggests that the integrity of the extracellular matrix may play an important role in preserving myocardial deformation .

###24462230
BACKGROUND	Treatment approaches for major depressive disorder ( MDD ) result in approximately one third of patients achieving remission after a first treatment .
BACKGROUND	Added treatment generally improves remission rates , but approximately one third of all patients fail to respond after several treatments ( sequential monotherapies or combined treatment ) .
BACKGROUND	A pretreatment biomarker could help identify these patients .
BACKGROUND	Overactivity of the subcallosal cingulate has been associated with failure of response to treatment in MDD , and it is a potential candidate for such a biomarker .
METHODS	Investigators enrolled 82 patients with MDD currently not receiving treatment in a two-phase treatment study .
METHODS	Patients underwent a fluorodeoxyglucose positron emission tomography scan .
METHODS	After scanning , patients were randomly assigned to 12 weeks of treatment with either escitalopram or cognitive-behavioral therapy ( CBT ) .
METHODS	Patients not achieving remission after 12 weeks of initial treatment were treated with an additional 12 weeks of escitalopram plus CBT .
METHODS	Subcallosal cingulate metabolism was compared between patients who failed to achieve a response and patients who achieved remission as a result of either phase one or phase two treatment .
METHODS	This analysis was followed by a whole-brain analysis making the same comparison .
RESULTS	After two phases of treatment ( 24 weeks ) , 36 patients were identified as remitters , 6 patients were responders , and 9 patients were nonresponders .
RESULTS	Subcallosal cingulate metabolism was significantly higher in nonresponders than remitters .
RESULTS	In the follow-up whole-brain analysis , increased superior temporal sulcus activity was also associated with nonresponse to two treatments .
CONCLUSIONS	Patients with MDD who fail to achieve remission as a result of CBT or escitalopram , either alone or in combination , have a distinct brain metabolic pattern compared with patients who achieve remission as a result of CBT , escitalopram , or their combination .

###25124938
BACKGROUND	World Health Organization ( WHO ) recommends that the episiotomy rate should be around 10 % , which is already a reality in many European countries .
BACKGROUND	Currently the use of episiotomy should be restricted and physicians are encouraged to use their clinical judgment to decide when the procedure is necessary .
BACKGROUND	There is no clinical evidence corroborating any indication of episiotomy , so until the present moment it is not yet known whether episiotomy is indeed necessary in any context of obstetric practice .
OBJECTIVE	To compare maternal and perinatal outcomes in women undergoing a protocol of not performing episiotomy versus selective episiotomy .
METHODS	An open label randomized clinical trial will be conducted including laboring women with term pregnancy , maximum dilation of 8 cm , live fetus in cephalic vertex presentation .
METHODS	Women with bleeding disorders of pregnancy , indication for caesarean section and those without capacity to consent and without legal guardians will be excluded .
METHODS	Primary outcomes will be frequency of episiotomy , delivery duration , frequency of spontaneous lacerations and perineal trauma , frequency of instrumental delivery , postpartum blood loss , need for perineal suturing , number of sutures , Apgar scores at one and five minutes , need for neonatal resuscitation and pH in cord blood .
METHODS	As secondary outcomes frequency complications of perineal suturing , postpartum perineal pain , maternal satisfaction , neonatal morbidity and admission newborn in NICU will be assessed .
METHODS	Women will be invited to participate and those who agree will sign the consent form and will be then assigned to a protocol of not conducting episiotomy ( experimental group ) or to a group that episiotomy is performed selectively according to the judgment of the provider of care delivery ( control Group ) .
METHODS	The present study was approved by IMIP 's Research Ethics Committee .
BACKGROUND	Clinical Trials Register under the number and was registered in ClinicalTrials.gov under the number NCT02178111 .

###25156527
BACKGROUND	Secondhand smoke ( SHS ) is a significant cause of acute respiratory illness ( ARI ) and 5 times more common in indigenous children .
BACKGROUND	A single-blind randomized trial was undertaken to determine the efficacy of a family centered SHS intervention to reduce ARI in indigenous infants in Australia and New Zealand .
METHODS	Indigenous mothers/infants from homes with 1 smoker were randomized to a SHS intervention involving 3 home visits in the first 3 months of the infants ' lives ( plus usual care ) or usual care .
METHODS	The primary outcome was number of ARI-related visits to a health provider in the first year of life .
METHODS	Secondary outcomes , assessed at 4 and 12 months of age , included ARI hospitalization rates and mothers ' report of infants ' SHS exposure ( validated by urinary cotinine/creatinine ratios [ CCRs ] ) , smoking restrictions , and smoking cessation .
RESULTS	Two hundred and ninety-three mother/infant dyads were randomized and followed up .
RESULTS	Three quarters of mothers smoked during pregnancy and two thirds were smoking at baseline ( as were their partners ) , with no change for more than 12 months .
RESULTS	Reported infant exposure to SHS was low ( 95 % had smoke-free homes/cars ) .
RESULTS	Infant CCRs were higher if one or both parents were smokers and if mothers breast fed their infants .
RESULTS	There was no effect of the intervention on ARI events [ 471 intervention vs. 438 usual care ( reference ) ; incidence rate ratio = 1.10 , 95 % confidence intervals ( CI ) = 0.88-1 .37 , p = .40 ] .
CONCLUSIONS	Despite reporting smoke-free homes/cars , mothers and their partners continue to smoke in the first year of infants ' lives , exposing them to SHS .
CONCLUSIONS	Emphasis needs to be placed on supporting parents to stop smoking preconception , during pregnancy , and postnatal .

###25039678
OBJECTIVE	Kangaroo care ( KC ) and maternal singing benefit preterm infants , and we investigated whether combining these benefitted infants and mothers .
METHODS	A prospective randomised , within-subject , crossover , repeated-measures study design was used , with participants acting as their own controls .
METHODS	We evaluated the heart rate variability ( HRV ) of stable preterm infants receiving KC , with and without maternal singing .
METHODS	This included low frequency ( LF ) , high frequency ( HF ) and the LF/HF ratio during baseline ( 10min ) , singing or quiet phases ( 20min ) and recovery ( 10min ) .
METHODS	Physiological parameters , maternal anxiety and the infants ' behavioural state were measured .
RESULTS	We included 86 stable preterm infants , with a postmenstrual age of 32-36weeks .
RESULTS	A significant change in LF and HF , and lower LF/HF ratio , was observed during KC with maternal singing during the intervention and recovery phases , compared with just KC and baseline ( all p-values < 0.05 ) .
RESULTS	Maternal anxiety was lower during singing than just KC ( p = 0.04 ) .
RESULTS	No differences in the infants ' behavioural states or physiological parameters were found , with or without singing .
CONCLUSIONS	Maternal singing during KC reduces maternal anxiety and leads to autonomic stability in stable preterm infants .
CONCLUSIONS	This effect is not detected in behavioural state or physiological parameters commonly used to monitor preterm infants .

###25591469
OBJECTIVE	Finerenone decreases albuminuria in patients having heart failure with reduced ejection fraction and mild-to-moderate ( stage 2-3 ) chronic kidney disease .
OBJECTIVE	The MinerAlocorticoid Receptor Antagonist Tolerability Study-Diabetic Nephropathy ( ARTS-DN ; NCT01874431 ) is a multicenter , randomized , double-blind , placebo-controlled , parallel-group , phase 2b study .
OBJECTIVE	ARTS-DN investigated whether the mineralocorticoid receptor antagonist finerenone reduces albuminuria without causing major alterations in serum potassium levels in patients with type 2 diabetes mellitus and a clinical diagnosis of DN who were receiving a renin-angiotensin-system ( RAS ) inhibitor .
METHODS	Patients were randomized to oral finerenone 1.25-20 mg or placebo once daily .
METHODS	The primary objectives were to assess the ratio of the urinary albumin-to-creatinine ratio at day 90 to that at baseline in patients receiving finerenone , and to compare it with that in the placebo group .
METHODS	Additional exploratory analyses included evaluating changes from baseline in serum potassium levels , efficacy and safety biomarkers , and health-related quality of life .
RESULTS	Of 1,501 patients screened , 821 ( the sample population ) received at least one dose of finerenone/placebo .
RESULTS	Baseline characteristics included : male , 77.8 % ; white , 84.2 % ; very high albuminuria ( formerly macroalbuminuria ) , 38.4 % ; high albuminuria ( formerly microalbuminuria ) , 60.3 % ; median ( range ) estimated glomerular filtration rate , 66.3 ( 24.5-130 .7 ) ml/min/1 .73 m ( 2 ) ; and systolic blood pressure ( mean standard deviation ) , 138.1 14.4 mm Hg .
RESULTS	There was a history of cardiovascular disease in 39.6 % , diabetic neuropathy in 20.0 % , and diabetic retinopathy in 19.9 % of patients .
CONCLUSIONS	ARTS-DN is the first phase 2b trial of finerenone in combination with a RAS inhibitor in patients with type 2 diabetes mellitus and a clinical diagnosis of DN .

###25458786
BACKGROUND	Postprandial elevation of triglycerides impairs endothelial function and contributes to the development of atherosclerosis .
BACKGROUND	We investigated the effects of omega-3 fatty acids on postprandial endothelial function and lipid profiles .
METHODS	Healthy volunteers [ 10 ] were given supplementation at 4g/day omega-3 fatty acids ( or were not treated ) for 4 weeks in a randomised crossover study .
METHODS	Postprandial levels of various lipids were monitored and endothelial function assessed by brachial artery flow-mediated dilation during fasting and after a standard cookie test .
RESULTS	Omega-3 fatty acids reduced postprandial endothelial dysfunction compared with the control diet ( flow-mediated dilation at 4h = -0.51.2 vs. -2.01.6 % , P = 0.03 ) .
RESULTS	Postprandial levels of triglycerides , apolipoprotein B-48 , and remnant lipoprotein-cholesterol increased in untreated subjects , peaked at 2-4h , and returned to baseline at 8h , whereas low-density lipoprotein-cholesterol levels did not change .
RESULTS	Supplementation with omega-3 fatty acids significantly suppressed postprandial elevation of triglycerides ( incremental area under the curve = 220209 vs. 374216mg/h/dL , P = 0.04 ) and remnant lipoprotein-cholesterol ( incremental area under the curve = 21.713.8 vs. 13.312.9 mg/h/dL , P = 0.04 ) .
RESULTS	Supplementation with omega-3 fatty acids significantly suppressed the increase in triglyceride content in chylomicrons as well as in very-low-density lipoproteins from baseline to 4h after the cookie test .
CONCLUSIONS	Omega-3 fatty acids significantly decreased postprandial triglyceride elevation and postprandial endothelial dysfunction , suggesting that omega-3 fatty acids may have vascular protective effects in postprandial state .

###24630479
OBJECTIVE	The beneficial results of a theory-practice pilot stress management program for Pharmacy and Biochemistry professionals and students .
OBJECTIVE	Its importance as a complement of traditional academic education , as well as its potential for Pharmaceutical Care is also discussed .
METHODS	A total of 27 students and 26 professionals took part in a program of 10 sessions , aimed at improving stress management .
METHODS	Ten of the students and 10 professionals were randomly assigned to control groups .
METHODS	Salivary cortisol levels and anxiety level tests before and after the program were used to assess efficacy .
RESULTS	Both the cortisol and the anxiety levels significantly decreased among students and professionals after the program , whereas it significantly increased in the student control group .
RESULTS	Anxiety levels significantly decreased in both students and professionals .
CONCLUSIONS	This type of pilot program proved effective for students .
CONCLUSIONS	In the case of health professionals , the sample size needs to be increased in order to achieve an acceptable level of statistical power .
CONCLUSIONS	Considering the shift of the pharmaceutical profession towards Pharmaceutical Care , the training of competences and attitudes like those described in this work could be of value .

###24509986
OBJECTIVE	This study aimed at comparing the effects of intermittent and repeated sprint ability training on physiological variables .
METHODS	Sixteen young female basketball players were randomly allocated to intermittent training ( IT = 8 ) or repeated sprint ability training ( RST = 8 ) groups .
METHODS	The following outcomes were measured at baseline and after 6 weeks of training : Yo-Yo intermittent recovery ( Yo-Yo ) and repeated sprint ability ( RSA ) tests .
RESULTS	For all the variables investigated the effect of training type showed a different trend respect at current knowledge .
RESULTS	In the RSA , best time ( BT ) was a significant main effect of training time ( pre - vs. post - ) ( P < 0.0001 ) , and of the interaction training type/time ( P = 0.03 ) .
RESULTS	The RST showed a decrease in BT of 3.1 % ( P = 0.005 ) while the IT showed a decrease of 6.2 % ( P < 0.0001 ) .
RESULTS	In the IT there was a significant main effect of time for the total distance with an increment of 26.9 % , and a significant main effect of time in the final speed with an increment of 1.23 % .
CONCLUSIONS	These findings suggest that the two training methods used in this study can be an effective training strategy for inducing anaerobic and basketball-specific training schedules .
CONCLUSIONS	Besides , even when IT training is not done at very high speed , it can increase the maximum speed of the RSA .

###24764339
OBJECTIVE	The purpose of this study was to differentiate perfusion and vascular characteristics between benign and malignant breast lesions by 3-dimensional contrast-enhanced sonography and evaluate their correlation with microvessel density and vascular endothelial growth factor ( VEGF ) expression for further clinical exploration .
METHODS	Three-dimensional contrast-enhanced sonography was performed in 183 patients with breast lesions , and sonographic characteristics were carefully observed for further analysis .
METHODS	The mean microvessel density and VEGF expression were measured by immunohistochemical analysis .
RESULTS	Pathologic results showed 35 benign and 148 malignant cases .
RESULTS	Malignancy and benignity differed significantly in peripheral vessel characteristics ( number , distribution , course , degree of dilatation , and penetrating vessels ) , rim perfusion and coarseness degree , intratumoral perfusion type , and intratumoral vessel dilatation ( P < .05 ) but not the presence of peripheral and intratumoral vessels and intratumoral perfusion ( P > .05 ) .
RESULTS	The specificity of penetrating vessels was 88.6 % for diagnosing malignancy .
RESULTS	The sensitivity , specificity , and accuracy of rim perfusion coarseness were 90.2 % , 70.4 % , and 85.3 % respectively .
RESULTS	The sensitivity of the intratumoral perfusion type was 77.8 % , whereas the specificity of intratumoral vessel dilatation was 88.9 % .
RESULTS	Microvessel density and VEGF expression were significantly correlated with perfusion and vascular characteristics ( P < .05 ) , except the presence of peripheral vessels , rim perfusion , and intratumoral perfusion ( P > .05 ) .
RESULTS	The presence of intratumoral vessels was related to VEGF ( P < .05 ) but not microvessel density ( P > .05 ) .
CONCLUSIONS	Three-dimensional contrast-enhanced sonographic characteristics were statistically different between benign and malignant breast lesions .
CONCLUSIONS	Some of them also correlated significantly with microvessel density and VEGF expression and therefore have potential for objective evaluation of tumor angiogenesis .

###25296654
BACKGROUND	Dehydroepiandrosterone ( DHEA ) has been proposed to improve pregnancy rates in women with diminished ovarian reserve undergoing in vitro fertilisation ( IVF ) treatment .
BACKGROUND	However , evidence regarding its efficacy is supported by a limited number of randomised controlled trials ( RCTs ) .
BACKGROUND	This double-blinded RCT aims to measure the effect of DHEA supplementation prior to and during controlled ovarian hyperstimulation on ovarian response prior to IVF treatment in women predicted to have poor ovarian reserve .
METHODS	Sixty women with ovarian antral follicle count 10 and serum anti-Mullerian hormone 5 pmol/L undergoing IVF/intracytoplasmic sperm injection ( ICSI ) treatment at the Nurture fertility clinic , Nottingham will be recruited .
METHODS	They will be randomised to either receive DHEA capsule 75mg/day or placebo for at least 12weeks before egg collection .
METHODS	All participants will undergo standard long down regulation protocol using human menopausal gonadotropin 300IU/day .
METHODS	Serum samples and follicular fluids at the time of egg collection will be collected for hormonal immunoassays .
METHODS	For ICSI participants , cumulus cells stripped from oocyte will be collected for cumulus gene expression analyses regarding oocyte competence .
METHODS	Microdrops of oocyte culture media before the time of ICSI will be assessed for glucose , pyruvate and lactate utilisation .
METHODS	Embryo transfer will be performed on day 2 , 3 or 5 based on the number and quality of the embryos available .
METHODS	Pregnancy will be defined as urine pregnancy test positive ( biochemical pregnancy ) and 6-8weeks ultrasound scan with fetal heart beat ( clinical pregnancy ) and live birth .
METHODS	It is planned to perform the molecular and nutritional fingerprint analyses in batches after finishing the clinical phase of the study .
BACKGROUND	The approval of the study was granted by the NHS Research Ethics Committee ( Ref number NRES 12/EM/0002 ) , the Medicines and Healthcare products Regulatory Agency ( MHRA ) , and the Nottingham University Hospitals Trust Research and Development department .
BACKGROUND	All participants shall provide written informed consent before being randomised into allocated treatment groups .
BACKGROUND	Protocol V. 2.0 ; EudraCT number : 2011-002425-21 ; http://www.clinicaltrials.gov; NCT01572025 ; CTA reference : 03057/0053/001 -0002 .

###24424433
BACKGROUND	Diabetes mellitus ( DM ) is an independent risk factor for atrial fibrillation ( AF ) .
BACKGROUND	Increased atrial electromechanical delay ( AEMD ) is known to be a precursor of AF .
BACKGROUND	In this study , we aimed to investigate AEMD in patients with type 2 DM .
METHODS	A total of 110 participants were recruited to the present study .
METHODS	Of them , 70 were diabetic patients , and 40 were healthy control subjects .
METHODS	Basal characteristics were recorded and transthoracic echocardiography was performed for all study participants .
RESULTS	Basal characteristics were similar between the two groups .
RESULTS	There was significant intra-atrial and interatrial electromechanical delay in the diabetic group compared with the control group .
RESULTS	In the correlation analysis , no correlation existed between AEMD and hemoglobin A1C or fasting plasma glucose levels .
CONCLUSIONS	In the present study , we showed that there was significant AEMD in patients with type 2 DM compared with healthy control subjects .
CONCLUSIONS	Increased AEMD might be an early marker of AF in this patient subset .
CONCLUSIONS	To clear this hypothesis , further studies are needed .

###25240704
BACKGROUND	People with opioid dependence and HIV are concentrated within criminal justice settings ( CJS ) .
BACKGROUND	Upon release , however , drug relapse is common and contributes to poor HIV treatment outcomes , increased HIV transmission risk , reincarceration and mortality .
BACKGROUND	Extended-release naltrexone ( XR-NTX ) is an evidence-based treatment for opioid dependence , yet is not routinely available for CJS populations .
METHODS	A randomized , double-blind , placebo-controlled trial of XR-NTX for HIV-infected inmates transitioning from correctional to community settings is underway to assess its impact on HIV and opioid-relapse outcomes .
RESULTS	We describe the methods and early acceptability of this trial .
RESULTS	In addition we provide protocol details to safely administer XR-NTX near community release and describe logistical implementation issues identified .
RESULTS	Study acceptability was modest , with 132 ( 66 % ) persons who consented to participate from 199 total referrals .
RESULTS	Overall , 79 % of the participants had previously received opioid agonist treatment before this incarceration .
RESULTS	Thus far , 65 ( 49 % ) of those agreeing to participate in the trial have initiated XR-NTX or placebo .
RESULTS	Of the 134 referred patients who ultimately did not receive a first injection , the main reasons included a preference for an alternative opioid agonist treatment ( 37 % ) , being ineligible ( 32 % ) , not yet released ( 10 % ) , and lost upon release before receiving their injection ( 14 % ) .
CONCLUSIONS	Study findings should provide high internal validity about HIV and opioid treatment outcomes for HIV-infected prisoners transitioning to the community .
CONCLUSIONS	The large number of patients who ultimately did not receive the study medication may raise external validity concerns due to XR-NTX acceptability and interest in opioid agonist treatments .
BACKGROUND	NCT01246401 .

###24493666
BACKGROUND	There is an ongoing debate regarding the optimal criteria for return to sport after an acute hamstring injury .
BACKGROUND	Less than 10 % isokinetic strength deficit is generally recommended but this has never been documented in professional football players after rehabilitation .
BACKGROUND	Our aim was to evaluate isokinetic measurements in MRI-positive hamstring injuries .
METHODS	Isokinetic measurements of professional football players were obtained after completing a standardised rehabilitation programme .
METHODS	An isokinetic strength deficit of more than 10 % compared with the contralateral site was considered abnormal .
METHODS	Reinjuries within 2months were recorded .
RESULTS	52 players had a complete set of isokinetic testing before clinical discharge .
RESULTS	There were 27 ( 52 % ) grade 1 and 25 ( 48 % ) grade 2 injuries .
RESULTS	35 of 52 players ( 67 % ) had at least one of the three hamstring-related isokinetic parameters that display a deficit of more than 10 % .
RESULTS	The percentage of players with 10 % deficit for hamstring concentric 60/s , 300/s and hamstring eccentric was respectively 39 % , 29 % and 28 % .
RESULTS	There was no significant difference of mean isokinetic peak torques and 10 % isokinetic deficits in players without reinjury ( N = 46 ) compared with players with reinjury ( N = 6 ) .
CONCLUSIONS	When compared with the uninjured leg , 67 % of the clinically recovered hamstring injuries showed at least one hamstring isokinetic testing deficit of more than 10 % .
CONCLUSIONS	Normalisation of isokinetic strength seems not to be a necessary result of the successful completion of a football-specific rehabilitation programme .
CONCLUSIONS	The possible association between isokinetic strength deficit and increased reinjury risk remains unknown .

###25383780
BACKGROUND	Early detection of lung cancer is crucial as the prognosis depends on the disease stage .
BACKGROUND	Chest radiographs has been the principal diagnostic tool for general practitioners ( GPs ) , but implies a potential risk of false negative results , while computed tomography ( CT ) has a higher sensitivity .
BACKGROUND	The aim of this study was to describe the implementation of direct access to low-dose CT ( LDCT ) from general practice .
METHODS	We conducted a cohort study nested in a randomised study .
METHODS	A total of 119 general practices with 266 GPs were randomised into two groups .
METHODS	Intervention GPs were offered direct access to chest LDCT combined with a Continuing Medical Education ( CME ) meeting on lung cancer diagnosis .
RESULTS	During a 19-month period , 648 patients were referred to LDCT ( 0.18 / 1000 adults on GP list/month ) .
RESULTS	Half of the patients needed further diagnostic work-up , and 15 ( 2.3 % , 95 % CI : 1.3-3 .8 % ) of the patients had lung cancer ; 60 % ( 95 % CI : 32.3-83 .7 % ) in a localised stage .
RESULTS	The GP referral rate was 61 % higher for CME participants compared to non-participants .
CONCLUSIONS	Of all patients referred to LDCT , 2.3 % were diagnosed with lung cancer with a favourable stage distribution .
CONCLUSIONS	Half of the referred patients needed additional diagnostic work-up .
CONCLUSIONS	There was an association between participation in CME and use of CT scan .
CONCLUSIONS	The proportion of cancers diagnosed through the usual fast-track evaluation was 2.2 times higher in the group of CME-participating GPs .
CONCLUSIONS	The question remains if primary care case-finding with LDCT is a better option for patients having signs and symptoms indicating lung cancer than a screening program .
CONCLUSIONS	Whether open access to LDCT may provide earlier diagnosis of lung cancer is yet unknown and a randomised trial is required to assess any effect on outcome .
BACKGROUND	Clinicaltrials.gov NCT01527214 .

###24998009
BACKGROUND	Many patients with advanced type 2 diabetes do not meet their glycated haemoglobin targets and randomised controlled studies comparing the efficacy of pump treatment and multiple daily injections for lowering glucose in insulin-treated patients have yielded inconclusive results .
BACKGROUND	We aimed to resolve this uncertainty with a randomised controlled trial ( OpT2mise ) .
METHODS	We did this multicentre , controlled trial at 36 hospitals , tertiary care centres , and referal centres in Canada , Europe , Israel , South Africa , and the USA .
METHODS	Patients with type 2 diabetes who had poor glycaemic control despite multiple daily injections with insulin analogues were enrolled into a 2-month dose-optimisation run-in period .
METHODS	After the run-in period , patients with glycated haemoglobin of 80-120 % ( 64-108 mmol/mol ) were randomly assigned ( 1:1 ) by a computer-generated randomisation sequence ( block size 2 with probability 075 and size 4 with probability 025 ) to pump treatment or to continue with multiple daily injections .
METHODS	Neither patients nor investigators were masked to treatment allocation .
METHODS	The primary endpoint was change in mean glycated haemoglobin between baseline and end of the randomised phase for the intention-to-treat population .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01182493 .
RESULTS	495 of 590 screened patients entered the run-in phase and 331 were randomised ( 168 to pump treatment , 163 to multiple daily injections ) .
RESULTS	Mean glycated haemoglobin at baseline was 9 % ( 75 mmol/mol ) in both groups .
RESULTS	At 6 months , mean glycated haemoglobin had decreased by 11 % ( SD 12 ; 12 mmol/mol , SD 13 ) in the pump treatment group and 04 % ( SD 11 ; 4 mmol/mol , SD 12 ) in the multiple daily injection group , resulting in a between-group treatment difference of -07 % ( 95 % CI -09 to -04 ; -8 mmol/mol , 95 % CI -10 to -4 , p < 00001 ) .
RESULTS	At the end of the study , the mean total daily insulin dose was 97 units ( SD 56 ) with pump treatment versus 122 units ( SD 68 ) for multiple daily injections ( p < 00001 ) , with no significant difference in bodyweight change between the two groups ( 15 kg [ SD 35 ] vs 11 kg [ 36 ] , p = 0322 ) .
RESULTS	Two diabetes-related serious adverse events ( hyperglycaemia or ketosis without acidosis ) resulting in hospital admission occurred in the pump treatment group compared with one in the multiple daily injection group .
RESULTS	No ketoacidosis occurred in either group and one episode of severe hypoglycaemia occurred in the multiple daily injection group .
CONCLUSIONS	In patients with poorly controlled type 2 diabetes despite using multiple daily injections of insulin , pump treatment can be considered as a safe and valuable treatment option .
BACKGROUND	Medtronic .

###24694983
BACKGROUND	Colchicine is effective for the treatment of acute pericarditis and first recurrences .
BACKGROUND	However , conclusive data are lacking for the efficacy and safety of colchicine for treatment of multiple recurrences of pericarditis .
METHODS	We did this multicentre , double-blind trial at four general hospitals in northern Italy .
METHODS	Adult patients with multiple recurrences of pericarditis ( two ) were randomly assigned ( 1:1 ) to placebo or colchicine ( 05 mg twice daily for 6 months for patients weighing more than 70 kg or 05 mg once daily for patients weighing 70 kg or less ) in addition to conventional anti-inflammatory treatment with aspirin , ibuprofen , or indometacin .
METHODS	Permuted block randomisation ( size four ) was done with a central computer-based automated sequence .
METHODS	Patients and all investigators were masked to treatment allocation .
METHODS	The primary outcome was recurrent pericarditis in the intention-to-treat population .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00235079 .
RESULTS	240 patients were enrolled and 120 were assigned to each group .
RESULTS	The proportion of patients who had recurrent pericarditis was 26 ( 216 % ) of 120 in the colchicine group and 51 ( 425 % ) of 120 in the placebo group ( relative risk 049 ; 95 % CI 024-065 ; p = 00009 ; number needed to treat 5 ) .
RESULTS	Adverse effects and discontinuation of study drug occurred in much the same proportions in each group .
RESULTS	The most common adverse events were gastrointestinal intolerance ( nine patients in the colchicine group vs nine in the placebo group ) and hepatotoxicity ( three vs one ) .
RESULTS	No serious adverse events were reported .
CONCLUSIONS	Colchicine added to conventional anti-inflammatory treatment significantly reduced the rate of subsequent recurrences of pericarditis in patients with multiple recurrences .
CONCLUSIONS	Taken together with results from other randomised controlled trials , these findings suggest that colchicine should be probably regarded as a first-line treatment for either acute or recurrent pericarditis in the absence of contraindications or specific indications .
BACKGROUND	Azienda Sanitaria 3 of Torino ( now ASLTO2 ) .

###24721127
BACKGROUND	Despite the increasing use of pre - and posthydration protocols and low-osmolar instead of high-osmolar iodine-containing contrast media , the incidence of contrast-induced nephropathy ( CIN ) is still significant .
BACKGROUND	There is evidence that contrast media cause ischemia-reperfusion injury of the medulla .
BACKGROUND	Remote ischemic preconditioning ( RIPC ) is a non-invasive , safe , and low-cost method to reduce ischemia-reperfusion injury .
METHODS	The RIPCIN study is a multicenter , single-blinded , randomized controlled trial in which 76 patients at risk of CIN will receive standard hydration combined with RIPC or hydration with sham preconditioning .
METHODS	RIPC will be applied by four cycles of 5min ischemia and 5min reperfusion of the forearm by inflating a blood pressure cuff at 50mmHg above the actual systolic pressure .
METHODS	The primary outcome measure will be the change in serum creatinine from baseline to 48 to 72h after contrast administration .
CONCLUSIONS	A recent pilot study reported that RIPC reduced the incidence of CIN after coronary angioplasty .
CONCLUSIONS	The unusual high incidence of CIN in this study is of concern and limits its generalizability .
CONCLUSIONS	Therefore , we propose a randomized controlled trial to study whether RIPC reduces contrast-induced kidney injury in patients at risk for CIN according to the Dutch guidelines .
BACKGROUND	Current Controlled Trials ISRCTN76496973 .

###24319686
OBJECTIVE	To assess the long-term effects of nilvadipine on the progression of central visual field defect in retinitis pigmentosa ( RP ) .
METHODS	Patients with RP were randomly divided into a treated group receiving oral nilvadipine and a control group .
METHODS	Progression of RP was evaluated with MD slope and the average sensitivity of the central 2 ( CENT4 ) .
RESULTS	The mean MD slopes were -0.55 / -0.39 ( right/left eyes , n = 19 ) dB/year in the treated group and -1.37 / -1.15 ( right/left eyes , n = 22 ) dB/year in the control group ( P = 0.016 / 0.050 , resp . )
RESULTS	In both eyes , however , no statistical difference was observed between the two groups for the CENT4 values .
CONCLUSIONS	Although we confirmed that nilvadipine significantly retarded the progression of the average of MD value defects in the central 10 , it was not specific for the central 2 of the visual field in RP .

###24708857
BACKGROUND	In Japan , combination therapy with high doses of antipsychotic drugs is common , but as a consequence , many patients with schizophrenia report extrapyramidal and autonomic nervous system side effects .
BACKGROUND	To resolve this , we proposed a method of safety correction of high dose antipsychotic polypharmacy ( the SCAP method ) , in which the initial total dose of all antipsychotic drugs is calculated and converted to a chlorpromazine equivalent ( expressed as milligrams of chlorpromazine , mg CP ) .
BACKGROUND	The doses of low-potency antipsychotic drugs are then reduced by 25 mg CP/week , and the doses of high-potency antipsychotics are decreased at a rate of 50 mg CP/week .
BACKGROUND	Although a randomized , case-controlled comparative study has demonstrated the safety of this method , the number of participants was relatively small and its results required further validation .
BACKGROUND	In this study of the SCAP method , we aimed to substantially increase the number of participants .
METHODS	The participants were in - or outpatients treated with two or more antipsychotics at doses of 500-1 ,500 mg CP/day .
METHODS	Consenting participants were randomized into control and dose reduction groups .
METHODS	In the control group , patients continued with their normal regimen for 3 months without a dose change before undergoing the SCAP protocol .
METHODS	The dose reduction group followed the SCAP strategy over 3-6 months with a subsequent 3-month follow-up period .
METHODS	Outcome measures were measured at baseline and then at 3-month intervals , and included clinical symptoms measured on the Manchester scale , the extent of extrapyramidal and autonomic side effects , and quality of life using the Euro QOL scale .
METHODS	We also measured blood drug concentrations and drug efficacy-associated biochemical parameters .
METHODS	The Brief Assessment of Cognition in Schizophrenia , Japanese version , was also undertaken in centers where it was available .
CONCLUSIONS	The safety and efficacy of the SCAP method required further validation in a large randomized trial .
CONCLUSIONS	The design of this study aimed to address some of the limitations of the previous case-controlled study , to build a more robust evidence base to assist clinicians in their efforts to reduce potentially harmful polypharmacy in this vulnerable group of patients .
BACKGROUND	UMIN Clinical Trials Registry 000004511 .

###25879721
BACKGROUND	To investigate the short-term cost-effectiveness of cognitive-behavioral therapy ( CBT ) and psychodynamic therapy ( PDT ) compared to waiting list ( WL ) .
METHODS	The analysis was conducted alongside the SOPHO-NET multi-center efficacy trial .
METHODS	Patients were randomly assigned to CBT ( n = 209 ) , PDT ( n = 207 ) , or WL ( n = 79 ) .
METHODS	Resource use was assessed prior and during treatment to determine direct and absenteeism costs .
METHODS	Unadjusted incremental cost-effectiveness ratios ( ICERs ) were calculated based on remission and response rates .
METHODS	To visualize statistical uncertainty , cost-effectiveness acceptability curves ( CEACs ) were constructed based on adjusted net-benefit regression .
METHODS	Different values for the societys willingness to pay ( WTP ) were assumed .
RESULTS	Both interventions were more efficacious than WL but were associated with increased direct costs besides intervention costs .
RESULTS	Unadjusted ICERs per responder were 3615 for CBT and 4958 for PDT .
RESULTS	Unadjusted ICERs per remitted patient were 5788 and 10,733 .
RESULTS	CEACs revealed a high degree of uncertainty : applying the 97.5 % probability threshold , CBT proved cost-effective at a WTP 16,100 per responder and 26,605 per remitted patient .
RESULTS	Regarding PDT cost-effectiveness only was certain for response at a WTP 27,290 .
CONCLUSIONS	The WL condition is assumed to represent untreated patients , although the expectation to start treatment in the near future probably affects symptom severity and health care utilization .
CONCLUSIONS	At the end of treatment cost-effectiveness of CBT and PDT compared to WL is uncertain and depends on the societal WTP .
CONCLUSIONS	The interventions may induce a more adequate utilization of other health care services - involving increased costs .
CONCLUSIONS	Development of costs and effects in the long-run should be considered .

###24401752
BACKGROUND	Diarrhea 's impact on childhood morbidity can be reduced by administering oral rehydration solution ( ORS ) with zinc ; challenges to wider use are changing health-seeking behavior and ensuring access .
METHODS	We conducted a randomized controlled trial to increase ORS plus zinc uptake in rural Myanmar .
METHODS	Village tracts , matched in 52 pairs , were randomized to standard ORS access vs. a social franchising program training community educators and supplying ORS plus zinc .
RESULTS	Intervention and control communities were comparable on demographics , prevalence of diarrhea and previous use of ORS .
RESULTS	One year after randomization , ORS plus zinc use was 13.7 % in the most recent case of diarrhea in intervention households compared with 1.8 % in control households ( p < 0.001 ) ( N = 3605 ) .
RESULTS	A significant increase in ORS plus zinc use was noted in the intervention ( p = 0.044 ) but not in the control ( p = 0.315 ) group .
CONCLUSIONS	Social franchising increased optimal treatment of childhood diarrhea in rural Myanmar .
CONCLUSIONS	Scale-up stands to reduce morbidity among children in similar settings .
BACKGROUND	Current Controlled Trials ISRCTN73606238 .

###25644856
OBJECTIVE	Salsalate treatment has well-known effects on improving glycemia , and the objective of this study was to examine whether the mechanism of this effect was related to changes in adipose tissue .
METHODS	A randomized double-blind and placebo-controlled trial in obese Hispanics ( 18-35 years ) was conducted .
METHODS	The intervention consisted of 4 g day ( -1 ) of salsalate ( n = 11 ) versus placebo ( n = 13 ) for 4 weeks .
METHODS	Outcome measures included glycemia , adiposity , ectopic fat , and adipose tissue gene expression and inflammation .
RESULTS	In those receiving salsalate , plasma fasting glucose decreased by 3.4 % ( P < 0.01 ) , free fatty acids decreased by 42.5 % ( P = 0.06 ) , and adiponectin increased by 27.7 % ( P < 0.01 ) .
RESULTS	Salsalate increased insulin AUC by 38 % ( P = 0.01 ) and HOMA-B by 47.2 % ( P < 0.01 ) while estimates of insulin sensitivity/resistance were unaffected .
RESULTS	These metabolic improvements occurred without changes in total , abdominal , visceral , or liver fat .
RESULTS	Plasma markers of inflammation/immune activation were unchanged following salsalate .
RESULTS	Salsalate had no effects on adipose tissue including adipocyte size , presence of crown-like structures , or gene expression of adipokines , immune cell markers , or cytokines downstream of NF-B with the exception of downregulation of IL-1 ( P < 0.01 ) .
CONCLUSIONS	Findings suggest that metabolic improvements in response to salsalate occurred without alterations in adiposity , ectopic fat , or adipose tissue gene expression and inflammation .

###24507553
BACKGROUND	Providing e-learning modules can be an effective strategy for enhancing gatekeepers ' knowledge , self-confidence and skills in adolescent suicide prevention .
BACKGROUND	The aim of this study was to test the effectiveness of an online training program called Mental Health Online which consists of eight short e-learning modules , each capturing an important aspect of the process of recognition , guidance and referral of suicidal adolescents ( 12-20years ) .
BACKGROUND	The primary outcomes of this study are participant 's ratings on perceived knowledge , perceived self-confidence , and actual knowledge regarding adolescent suicidality .
METHODS	A randomized controlled trial will be carried out among 154 gatekeepers .
METHODS	After completing the first assessment ( pre-test ) , participants will be randomly assigned to either the experimental group or the waitlist control group .
METHODS	One week after completing the first assessment the experimental group will have access to the website Mental Health Online containing the eight e-learning modules and additional information on adolescent suicide prevention .
METHODS	Participants in both conditions will be assessed 4weeks after completing the first assessment ( post-test ) , and 12weeks after completing the post-test ( follow-up ) .
METHODS	At post-test , participants from the experimental group are asked to complete an evaluation questionnaire on the modules .
METHODS	The waitlist control group will have access to the modules and additional information on the website after completing the follow-up assessment .
CONCLUSIONS	Gatekeepers can benefit from e-learning modules on adolescent suicide prevention .
CONCLUSIONS	This approach allows them to learn about this sensitive subject at their own pace and from any given location , as long as they have access to the Internet .
CONCLUSIONS	Given the flexible nature of the program , each participant can compose his/her own training creating an instant customized course with the required steps in adolescent suicide prevention .
BACKGROUND	Netherlands Trial Register NTR3625 .

###25530148
BACKGROUND	Researchers and participants ' expectations can influence treatment response .
BACKGROUND	Less is known about the effects of researchers ' expectations on the accuracy of data collection in the context of a weight loss trial .
METHODS	Student raters ( N = 58 ; age = 20.12.3 years ) were recruited to weigh individuals who they thought were completing a 12-month weight loss trial , although these ` participants ' were actually standardized patients ( SPs ) playing these roles .
METHODS	Prior to data collection , student raters were provided information suggesting that the tested treatment had been effective .
METHODS	Each student rater received a list of 9-10 ` participants ' to weigh .
METHODS	While the list identified each person as ` treatment ' or ` control ' , this assignment was at random , which allowed us to examine the effects of non-blinding and expectancy manipulation on weight measurement accuracy .
METHODS	We hypothesized that raters would record the weights of ` treatment participants ' as lower than those of ` control participants ' .
RESULTS	Contrary to our hypothesis , raters recorded weights that were 0.293 kg heavier when weighing ` treatment ' vs. ` control ' SPs , although this difference was not significant ( P = 0.175 ) .
CONCLUSIONS	This pilot study found no evidence that manipulating expectancies about treatment efficacy or not blinding raters biased measurements .
CONCLUSIONS	Future work should examine other biases which may be created by not blinding research staff who implement weight loss trials as well as the participants in those trials .

###25629790
OBJECTIVE	To evaluate the efficacy and long-term safety of linagliptin added to basal insulin in Asian patients with type 2 diabetes mellitus ( T2DM ) inadequately controlled by basal insulin with/without oral agents .
METHODS	This was a post hoc analysis of Asian patients from a global 52 week study in which patients on basal insulin were randomized ( 1:1 ) to double-blind treatment with linagliptin 5mg once daily or placebo ( NCT00954447 ) .
METHODS	Basal insulin dose remained stable for 24 weeks , after which adjustments could be made according to the investigator 's discretion to improve glycemic control .
METHODS	The primary endpoint was the mean change in glycated hemoglobin ( HbA1c ) from baseline to 24 weeks .
RESULTS	Data were available for 154 Asian patients ( 80 linagliptin , 74 placebo ) .
RESULTS	Baseline HbA1c ( standard deviation [ SD ] ) was 8.6 ( 0.9 ) % ( 70 [ 10 ] mmol/mol ) .
RESULTS	The placebo-corrected mean change ( standard error [ SE ] ) in HbA1c from baseline was -0.9 ( 0.1 ) % ( -10 [ 1 ] mmol/mol ) ( 95 % confidence interval [ CI ] : -1.2 , -0.7 ; p < 0.0001 ) at Week 24 and -0.9 ( 0.1 ) % ( -10 [ 1 ] mmol/mol ) ( 95 % CI : -1.1 , -0.6 ; p < 0.0001 ) at Week 52 .
RESULTS	The frequency of adverse events ( linagliptin 81.3 % , placebo 91.9 % ) and hypoglycemia ( Week 24 : linagliptin 25.0 % , placebo 25.7 % ; treatment end : linagliptin 28.8 % , placebo 35.1 % ) was similar between groups .
RESULTS	By Week 52 , changes ( SE ) in mean body weight were similar in both groups ( linagliptin -0.67 [ 0.26 ] kg , placebo -0.38 [ 0.25 ] kg ) .
CONCLUSIONS	This study was limited by the post hoc nature of the analysis and the small number of patients in the subgroup .
CONCLUSIONS	However , the results suggest that linagliptin significantly improves glycemic control in Asian patients with T2DM inadequately controlled by basal insulin , without increasing the risk for hypoglycemia or weight gain .
CONCLUSIONS	ClinicalTrials identifier : NCT00954447 .

###24814607
BACKGROUND	Dual dependence on opiate and cocaine occurs in about 60 % of patients admitted to methadone maintenance and negatively impacts prognosis ( Kosten et al. 2003 .
BACKGROUND	Drug Alcohol Depend .
BACKGROUND	70 , 315 ) .
BACKGROUND	Topiramate ( TOP ) is an antiepileptic drug that may have utility in the treatment of cocaine dependence because it enhances the GABAergic system , antagonizes the glutamatergic system , and has been identified by NIDA as one of only a few medications providing a `` positive signal '' warranting further clinical investigation .
BACKGROUND	( Vocci and Ling , 2005 .
BACKGROUND	Pharmacol .
BACKGROUND	Ther .
BACKGROUND	108 , 94 ) .
METHODS	In this double-blind controlled clinical trial , cocaine dependent methadone maintenance patients ( N = 171 ) were randomly assigned to one of four groups .
METHODS	Under a factorial design , participants received either TOP or placebo , and monetary voucher incentives that were either contingent ( CM ) or non-contingent ( Non-CM ) on drug abstinence .
METHODS	TOP participants were inducted onto TOP over 7 weeks , stabilized for 8 weeks at 300 mg daily then tapered over 3 weeks .
METHODS	Voucher incentives were supplied for 12 weeks , starting during the fourth week of TOP induction .
METHODS	Primary outcome measures were cocaine abstinence ( Y/N ) as measured by thrice weekly urinalysis and analyzed using Generalized Estimating Equations ( GEE ) and treatment retention .
METHODS	All analyses were intent to treat and included the 12-week evaluation phase of combined TOP/P treatment and voucher intervention period .
RESULTS	There was no significant difference in cocaine abstinence between the TOP vs. P conditions nor between the CM vs. Non-CM conditions .
RESULTS	There was no significant TOP/CM interaction .
RESULTS	Retention was not significantly different between the groups .
CONCLUSIONS	Topiramate is not efficacious for increasing cocaine abstinence in methadone patients .

###24245778
OBJECTIVE	The question-behaviour effect ( QBE ) refers to the finding that measuring behavioural intentions increases performance of the relevant behaviour .
OBJECTIVE	This effect has been used to change health behaviours .
OBJECTIVE	The present research asks why the QBE occurs and evaluates one possible mediator-attitude accessibility .
METHODS	University staff and students ( N = 151 ) were randomly assigned to an intention measurement condition where they reported their intentions to eat healthy foods , or to one of two control conditions .
METHODS	Participants completed a response latency measure of attitude accessibility , before healthy eating behaviour was assessed unobtrusively using an objective measure of snacking .
RESULTS	Intention measurement participants exhibited more accessible attitudes towards healthy foods , and were more likely to choose a healthy snack , relative to control participants .
RESULTS	Furthermore , attitude accessibility mediated the relationship between intention measurement and behaviour .
CONCLUSIONS	This research demonstrates that increased attitude accessibility may explain the QBE , extending the findings of previous research to the domain of health behaviour .

###24499830
BACKGROUND	Laparoscopy-assisted distal gastrectomy ( LADG ) for gastric cancer may prevent the development of an impaired nutritional status due to reduced surgical stress compared with open distal gastrectomy ( ODG ) .
METHODS	This study was performed as an exploratory analysis of a phase III trial comparing LADG and ODG for stage I gastric cancer during the period between May and December of 2011 .
METHODS	All patients received the same perioperative care via fast-track surgery .
METHODS	The level of surgical stress was evaluated based on the white blood cell count and the interleukin-6 ( IL-6 ) level .
METHODS	The nutritional status was measured according to the total body weight , amount of lean body mass , lymphocyte count , and prealbumin level .
RESULTS	Twenty-six patients were randomized to receive ODG ( 13 patients ) or LADG ( 13 patients ) .
RESULTS	The baseline characteristics and surgical outcomes were similar between the two groups .
RESULTS	The median IL-6 level increased from 0.8 to 36.3 pg/dl in the ODG group and from 1.5 to 53.3 pg/dl in the LADG group .
RESULTS	The median amount of lean body mass decreased from 48.3 to 46.8 kg in the ODG group and from 46.6 to 46.0 kg in the LADG group .
RESULTS	There are no significant differences between two groups .
CONCLUSIONS	The level of surgical stress and the nutritional status were found to be similar between the ODG and LADG groups in a randomized comparison using the same perioperative care of fast-track surgery .

###24496960
OBJECTIVE	From a previously validated paediatric population pharmacokinetic model , it was derived that non-linear morphine maintenance doses of 5 g/kg ( 1.5 ) / h , with a 50 % dose reduction in neonates with a postnatal age ( PNA ) < 10 days , yield similar morphine and metabolite concentrations across patients younger than 3 years .
OBJECTIVE	Compared with traditional dosing , this model-derived dosing regimen yields significantly reduced doses in neonates aged < 10 days .
METHODS	Concentration predictions of the population model were prospectively evaluated in postoperative term neonates and infants up to the age of 1 year who received morphine doses according to the model-derived algorithm .
METHODS	The efficacy of this dosing algorithm was evaluated using morphine rescue medication and actual average infusion rates .
RESULTS	Morphine and metabolite concentrations were accurately predicted by the paediatric pharmacokinetic morphine model .
RESULTS	With regard to efficacy , 5 out of 18 neonates ( 27.8 % ) with a PNA of < 10 days needed rescue medication versus 18 of the 20 older patients ( 90 % ) ( p = 0.06 ) .
RESULTS	The median ( interquartile range [ IQR ] ) total morphine rescue dose was 0 ( 0-20 ) g/kg in younger patients versus 193 ( 19-362 ) g/kg in older patients ( p = 0.003 ) .
RESULTS	The median ( IQR ) actual average morphine infusion rate was 4.4 ( 4.0-4 .8 ) g/kg/h in younger patients versus 14.4 ( 11.3-23 .4 ) g/kg/h in older patients ( p < 0.001 ) .
CONCLUSIONS	Morphine paediatric dosing algorithms corrected for pharmacokinetic differences alone yield effective doses that prevent over-dosing for neonates with a PNA < 10 days .
CONCLUSIONS	The fact that many neonates and infants with a PNA 10 days still required rescue medication warrants pharmacodynamic studies to further optimize the dosing algorithm for these patients .

###24587006
BACKGROUND	Palonosetron is a potent second generation 5 - hydroxytryptamine-3 selective antagonist which can be administered by either intravenous ( IV ) or oral routes , but subcutaneous ( SC ) administration of palonosetron has never been studied , even though it could have useful clinical applications .
BACKGROUND	In this study , we evaluate the bioavailability of SC palonosetron .
METHODS	Patients treated with platinum-based chemotherapy were randomized to receive SC or IV palonosetron , followed by the alternative route in a crossover manner , during the first two cycles of chemotherapy .
METHODS	Blood samples were collected at baseline and 10 , 15 , 30 , 45 , 60 , 90 minutes and 2 , 3 , 4 , 6 , 8 , 12 and 24 h after palonosetron administration .
METHODS	Urine was collected during 12 hours following palonosetron .
METHODS	We compared pharmacokinetic parameters including AUC0-24h , t1/2 , and Cmax observed with each route of administration by analysis of variance ( ANOVA ) .
RESULTS	From October 2009 to July 2010 , 25 evaluable patients were included .
RESULTS	AUC0-24h for IV and SC palonosetron were respectively 14.1 and 12.7 ng h/ml ( p = 0.160 ) .
RESULTS	Bioavalability of SC palonosetron was 118 % ( 95 % IC : 69-168 ) .
RESULTS	Cmax was lower with SC than with IV route and was reached 15 minutes following SC administration .
CONCLUSIONS	Palonosetron bioavailability was similar when administered by either SC or IV route .
CONCLUSIONS	This new route of administration might be specially useful for outpatient management of emesis and for administration of oral chemotherapy .
BACKGROUND	ClinicalTrials.gov NCT01046240 .

###25533966
BACKGROUND	Inorganic nitrate ( NO3 ( - ) ) , abundant in certain vegetables , is converted to nitrite by bacteria in the oral cavity .
BACKGROUND	Nitrite can be converted to nitric oxide in the setting of hypoxia .
BACKGROUND	We tested the hypothesis that NO3 ( - ) supplementation improves exercise capacity in heart failure with preserved ejection fraction via specific adaptations to exercise .
RESULTS	Seventeen subjects participated in this randomized , double-blind , crossover study comparing a single dose of NO3-rich beetroot juice ( NO3 ( - ) , 12.9 mmol ) with an identical nitrate-depleted placebo .
RESULTS	Subjects performed supine-cycle maximal-effort cardiopulmonary exercise tests , with measurements of cardiac output and skeletal muscle oxygenation .
RESULTS	We also assessed skeletal muscle oxidative function .
RESULTS	Study end points included exercise efficiency ( total work/total oxygen consumed ) , peak VO2 , total work performed , vasodilatory reserve , forearm mitochondrial oxidative function , and augmentation index ( a marker of arterial wave reflections , measured via radial arterial tonometry ) .
RESULTS	Supplementation increased plasma nitric oxide metabolites ( median , 326 versus 10 mol/L ; P = 0.0003 ) , peak VO2 ( 12.63.7 versus 11.63.1 mL O2min ( -1 ) kg ( -1 ) ; P = 0.005 ) , and total work performed ( 55.635.3 versus 49.228.9 kJ ; P = 0.04 ) .
RESULTS	However , efficiency was unchanged .
RESULTS	NO3 ( - ) led to greater reductions in systemic vascular resistance ( -42.416.6 % versus -31.820.3 % ; P = 0.03 ) and increases in cardiac output ( 121.259.9 % versus 88.753.3 % ; P = 0.006 ) with exercise .
RESULTS	NO3 ( - ) reduced aortic augmentation index ( 132.216.7 % versus 141.421.9 % ; P = 0.03 ) and tended to improve mitochondrial oxidative function .
CONCLUSIONS	NO3 ( - ) increased exercise capacity in heart failure with preserved ejection fraction by targeting peripheral abnormalities .
CONCLUSIONS	Efficiency did not change as a result of parallel increases in total work and VO2 .
CONCLUSIONS	NO3 ( - ) increased exercise vasodilatory and cardiac output reserves .
CONCLUSIONS	NO3 ( - ) also reduced arterial wave reflections , which are linked to left ventricular diastolic dysfunction and remodeling .
BACKGROUND	www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01919177 .

###25305763
BACKGROUND	The combination of pulsed dye laser ( PDL ) and topical propranolol are used with variable effectiveness for the treatment of infantile hemangiomas ( IH ) , particularly for superficial lesions .
OBJECTIVE	The aim of this study was to investigate whether the therapeutic efficacy of prescribing topical propranolol along with PDL was superior to PDL therapy alone in the treatment of IH .
METHODS	A total of 19 patients with IH were recruited to the study .
METHODS	Among them , nine patients were treated with PDL , 3 sessions 4 weeks apart , and 10 patients underwent PDL treatment alongside with topical propranolol for 12 weeks .
METHODS	The therapeutic efficacies of each regimen were assessed by comparing photographs of skin lesions before and after the treatment based on the cessation of the lesion growth , reduction in the lesion size , and lightening of the lesion color .
RESULTS	No side-effect was reported by the parents .
RESULTS	Among nine patients in PDL group , only two ( 22 % ) had excellent clearance , one ( 11 % ) had good , three ( 30 % ) had weak , and three ( 30 % ) had no responses .
RESULTS	On the other hand , among 10 patients who were treated with both the PDL and topical propranolol , five ( 50 % ) showed excellent responses and five ( 50 % ) displayed good responses .
RESULTS	Statistical data analysis with Mann-Whitney test revealed a significant difference in the clinical response between two treatment groups .
CONCLUSIONS	The combination of PDL and topical propranolol seem to be a safe and effective therapy , and results in better clinical responses in the treatment of IH than PDL therapy alone .

###25855884
BACKGROUND	Surfactant has been shown to be dysfunctional in ARDS , and exogenous surfactant has proven effective in many forms of neonatal and pediatric acute lung injury ( ALI ) .
BACKGROUND	In view of the positive results of our studies in children along with evidence that surfactant-associated protein B containing pharmaceutical surfactants might be more effective , we designed a multiinstitutional , randomized , controlled , and masked trial of calfactant , a calf lung surfactant , in adults and children with ALI/ARDS due to direct lung injury .
METHODS	Adult subjects within 48 h of initiation of mechanical ventilation for direct ARDS were randomized to receive up to three interventions with instilled calfactant vs air placebo .
METHODS	The primary outcome was 90-day all-cause mortality .
RESULTS	Three hundred seventeen subjects were enrolled , 308 of whom could be evaluated .
RESULTS	There were no significant baseline differences between groups .
RESULTS	Calfactant administration was not associated with improved survival , lengths of stay , or oxygenation .
RESULTS	Calfactant instillation was frequently associated with transient hypoxia and hypotension .
RESULTS	The study was stopped at the first interim analysis at the sponsor 's request .
CONCLUSIONS	Administration of calfactant was not associated with improved oxygenation or longer-term benefits relative to placebo in this randomized , controlled , and masked trial .
CONCLUSIONS	At present , exogenous surfactant can not be recommended for routine clinical use in ARDS .
BACKGROUND	ClinicalTrials.gov ; No. : NCT00682500 ; URL : www.clinicaltrials.gov .

###25563312
BACKGROUND	Herpes simplex keratitis ( HSK ) caused by herpes simplex virus 1 ( HSV-1 ) , which has high recurrent rate and incidence of severe vision loss , is the leading cause of infectious blindness in the world .
BACKGROUND	The aim was to explore the clinical efficacy of oral ganciclovir ( GCV ) in the prevention of recurrent HSK .
METHODS	A multicenter , prospective , randomized , single-blind , and controlled clinical trial was conducted from April 2010 to June 2013 .
METHODS	One hundred seventy-three patients ( 173 eyes involved ) who were diagnosed as recurrent HSK definitely , including stromal keratitis and corneal endotheliitis , were divided into three groups randomly : negative control ( placebo ) group was topically administered with 0.15 % GCV ophthalmic gel , 4 times per day and 0.1 % fluorometholone eye drops , 3 times per day until resolution of HSK ; positive control acyclovir ( ACV ) group was topically adopted the same ophthalmic gel and eye drops and additionally received oral ACV 400 mg 5 times a day for 10 weeks and followed by 400 mg 2 times per day for 6 months ; test GCV group was topically adopted the same treatment as negative control group and additionally received oral GCV 1000 mg 3 times per day for 8 weeks .
METHODS	The symptoms and signs were evaluated before and after the therapy 1 st week , 2 nd week and then followed up every 2 weeks until recovery .
METHODS	Furthermore , we followed up recurrence of HSK for every 3 months after recovery and then assessed the cure time , recurrent rate and adverse reactions .
RESULTS	One hundred and seventy-three patients were followed up 7-48 months ( mean 32.1 12.3 months ) , but 34 patients were failed to follow-up .
RESULTS	The cure time was 12.1 4.3 , 11.9 4.0 weeks in negative control ( placebo ) group and positive control ACV group respectively ( P = 0.991 ) , which was longer than that in test GCV group ( 8.6 2.8 weeks ) and there was a significant difference between test GCV group and negative control ( placebo ) group or positive control ACV group ( P = 0.000 ) .
RESULTS	Furthermore , the recurrent rate was higher in negative control ( placebo ) group ( 47.3 % ) than that in positive control group ACV ( 26.7 % ) and test GCV group ( 17.2 % ) , and there was a great significant difference among the three groups ( P = 0.007 ) , but there was no significant difference between positive control ACV group and test GCV group ( P = 0.358 ) .
RESULTS	In addition , there was no obvious adverse reaction expect neutropenia ( only one patient in test GCV group ) .
CONCLUSIONS	Short-term oral GCV could cure recurrent HSK and endotheliitis , shorten the course , reduce recurrent rate of HSK and have confirmed safety .

###25686117
OBJECTIVE	We planned a randomized , open-label trial to evaluate differences between pre-emptive and reactive skin treatment for panitumumab ( Pmab ) - associated skin toxicities in Japanese patients with metastatic colorectal cancer .
METHODS	Patients receiving third-line Pmab-containing regimens were randomized to pre-emptive or reactive treatment .
METHODS	The primary end point was the cumulative incidence of grade 2 skin toxicities during 6 weeks .
METHODS	Retrospectively , a dermatologist reviewed skin toxicities , in a blinded manner .
RESULTS	A total of 95 patients were enrolled ( pre-emptive : 47 , reactive : 48 ) .
RESULTS	The primary end point was achieved ( 21.3 and 62.5 % [ risk ratio : 0.34 ; p < 0.001 ] , for pre-emptive and reactive treatment , respectively ) .
RESULTS	A similar trend was observed in central review .
CONCLUSIONS	Pre-emptive skin treatment could reduce the severity of Pmab-associated skin toxicities in Japanese metastatic colorectal cancer patients .

###26095784
BACKGROUND	VEGF and VEGF receptor-2-mediated angiogenesis contribute to hepatocellular carcinoma pathogenesis .
BACKGROUND	Ramucirumab is a recombinant IgG1 monoclonal antibody and VEGF receptor-2 antagonist .
BACKGROUND	We aimed to assess the safety and efficacy of ramucirumab in advanced hepatocellular carcinoma following first-line therapy with sorafenib .
METHODS	In this randomised , placebo-controlled , double-blind , multicentre , phase 3 trial ( REACH ) , patients were enrolled from 154 centres in 27 countries .
METHODS	Eligible patients were aged 18 years or older , had hepatocellular carcinoma with Barcelona Clinic Liver Cancer stage C disease or stage B disease that was refractory or not amenable to locoregional therapy , had Child-Pugh A liver disease , an Eastern Cooperative Oncology Group performance status of 0 or 1 , had previously received sorafenib ( stopped because of progression or intolerance ) , and had adequate haematological and biochemical parameters .
METHODS	Patients were randomly assigned ( 1:1 ) to receive intravenous ramucirumab ( 8 mg/kg ) or placebo every 2 weeks , plus best supportive care , until disease progression , unacceptable toxicity , or death .
METHODS	Randomisation was stratified by geographic region and cause of liver disease with a stratified permuted block method .
METHODS	Patients , medical staff , investigators , and the funder were masked to treatment assignment .
METHODS	The primary endpoint was overall survival in the intention-to-treat population .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01140347 .
RESULTS	Between Nov 4 , 2010 , and April 18 , 2013 , 565 patients were enrolled , of whom 283 were assigned to ramucirumab and 282 were assigned to placebo .
RESULTS	Median overall survival for the ramucirumab group was 92 months ( 95 % CI 80-106 ) versus 76 months ( 60-93 ) for the placebo group ( HR 087 [ 95 % CI 072-105 ] ; p = 014 ) .
RESULTS	Grade 3 or greater adverse events occurring in 5 % or more of patients in either treatment group were ascites ( 13 [ 5 % ] of 277 patients treated with ramucirumab vs 11 [ 4 % ] of 276 patients treated with placebo ) , hypertension ( 34 [ 12 % ] vs ten [ 4 % ] ) , asthenia ( 14 [ 5 % ] vs five [ 2 % ] ) , malignant neoplasm progression ( 18 [ 6 % ] vs 11 [ 4 % ] ) , increased aspartate aminotransferase concentration ( 15 [ 5 % ] vs 23 [ 8 % ] ) , thrombocytopenia ( 13 [ 5 % ] vs one [ < 1 % ] ) , hyperbilirubinaemia ( three [ 1 % ] vs 13 [ 5 % ] ) , and increased blood bilirubin ( five [ 2 % ] vs 14 [ 5 % ] ) .
RESULTS	The most frequently reported ( 1 % ) treatment-emergent serious adverse event of any grade or grade 3 or more was malignant neoplasm progression .
CONCLUSIONS	Second-line treatment with ramucirumab did not significantly improve survival over placebo in patients with advanced hepatocellular carcinoma .
CONCLUSIONS	No new safety signals were noted in eligible patients and the safety profile is manageable .
BACKGROUND	Eli Lilly and Co. .

###25328464
BACKGROUND	Early ceramic bearing systems in total hip arthoplasty ( THA ) sought to provide long term wear improvement over traditional metal on polyethylene systems .
BACKGROUND	However , previous designs exhibited fractures of the ceramic acetabular liner , leading to the development of the Implex Hedrocel ceramic bearing THA system where the ceramic liner was supported on a layer of polyethylene intended to transition liner loads to the metal shell , a so-called `` sandwich '' design .
BACKGROUND	Unfortunately , the device trial was stopped to further enrollment when liner fractures were reported .
BACKGROUND	The current study examines nearly 10-year follow-up on 28 devices implanted by two surgeons at one institution in order to document ceramic bearing system performance over a longer time period .
METHODS	Radiographic and patient reported outcomes , in the form of Harris Hip Scores ( HHS ) and 12-Item Short Form Health Survey ( sF-12 ) , were collected .
RESULTS	During the study period two cups were replaced , one at three years and a second at seven years .
RESULTS	At the five year follow-up HHS were similar to those reported in the literature for devices with traditional metal-on-polyethylene bearing surfaces and for other sandwich ceramic bearing designs .
RESULTS	At the nine year follow-up , the HHS had not changed significantly and SF-12 scores measuring overall physical and mental health were higher than age matched national norms ( p < 0.001 ) .
RESULTS	There were no signs of cup migration , stem subsidence , osteolysis or cup loosening at any time up to the last follow-up in this patient cohort .
RESULTS	The 89 % survivorship rate and device revisions due to delamination of the liner observed in this group were similar to those reported earlier for this device and for other `` sandwich design '' ceramic bearing systems .
CONCLUSIONS	This cohort did not exhibit new failure modes and HHS and SF-12 scores indicated high functionality for the majority of patients .
CONCLUSIONS	These data suggest that a focus on preventing ceramic liner fracture through design and/or materials improvements may result in a device with long-term functionality .

###24565240
OBJECTIVE	In this study , our aim was to evaluate the effects of intravenous dexketoprofen trometamol with ilioinguinal and iliohypogastric nerve block on analgesic quality and morphine consumption after total abdominal hysterectomy operations .
METHODS	We conducted this randomized controlled clinical study on 61 patients .
METHODS	The study was conducted in the operation room , post-anesthesia care unit , and inpatient clinic .
METHODS	We randomly grouped the 61 patients into control group ( group C ) , block group ( group B ) and dexketoprofen-block group ( group DB ) .
METHODS	Before the skin incision performed after anesthesia induction , we performed ilioinguinal iliohypogastric block ( group C given saline and group P and DB given levobupivacaine ) .
METHODS	In contrast to group C and B , group DB was given dexketoprofen .
METHODS	We administered morphine analgesia to all patients by patient-controlled analgesia ( PCA ) during the postoperative 24 hours .
METHODS	We recorded Visual Analogue Scale ( VAS ) , satisfaction scores , morphine consumption and side effects during postoperative 24 hours .
RESULTS	We found the DB group 's VAS scores to be lower than the control group and block group 's ( p < 0.05 ) values at postoperative 1 ( st ) , 2 ( nd ) , 6 ( th ) and 12 ( th ) hours .
RESULTS	VAS scores of group C were higher than of group B at postoperative first 2 hours .
RESULTS	Time to first PCA demand was longer , morphine consumption values were lower and satisfaction scores were higher in group DB than in the other two groups ( p < 0.05 ) .
CONCLUSIONS	Ilioinguinal-iliohypogastric nerve block with IV dexketoprofen increases patient satisfaction by decreasing opioid consumption , increasing patient satisfaction , which suggests that dexketoprofen trometamol is an effective non-steroidal anti-inflammatory analgesic in postoperative analgesia .

###24532276
OBJECTIVE	To determine whether strict blood pressure ( BP ) control is the best medical management for patients with symptomatic carotid artery occlusion and hemodynamic cerebral ischemia .
METHODS	In this prospective observational cohort study , we analyzed data from 91 participants in the nonsurgical group of the Carotid Occlusion Surgery Study ( COSS ) who had recent symptomatic internal carotid artery occlusion and hemodynamic cerebral ischemia manifested by ipsilateral increased oxygen extraction fraction .
METHODS	The target BP goal in COSS was 130/85 mm Hg .
METHODS	We compared the occurrence of ipsilateral ischemic stroke during follow-up in the 41 participants with mean BP 130/85 mm Hg to the remaining 50 with higher BP .
RESULTS	Of 16 total ipsilateral ischemic strokes that occurred during follow-up , 3 occurred in the 41 participants with mean follow-up BP of 130/85 mm Hg , compared to 13 in the remaining 50 participants with mean follow-up BP > 130/85 mm Hg ( hazard ratio 3.742 , 95 % confidence interval 1.065-13 .152 , log-rank p = 0.027 ) .
CONCLUSIONS	BPs 130/85 mm Hg were associated with lower subsequent stroke risk in these patients .
METHODS	This study provides Class III evidence that control of hypertension 130/85 mm Hg is associated with a reduced risk of subsequent ipsilateral ischemic stroke in patients with recently symptomatic carotid occlusion and hemodynamic cerebral ischemia ( increased oxygen extraction fraction ) .

###24585363
BACKGROUND	Arthroscopic capsular release is an effective treatment for shoulder stiffness , yet its extent is controversial .
OBJECTIVE	To compare the clinical outcomes of arthroscopic capsular release in patients with and without posterior extended capsular release for shoulder stiffness .
METHODS	Randomized controlled trial ; Level of evidence , 1 .
METHODS	Between January 2008 and March 2011 , 75 patients who underwent arthroscopic capsular release for shoulder stiffness were enrolled and randomized into 2 groups .
METHODS	In group I ( n = 37 ) , capsular release was performed , including release of the rotator interval and anterior and inferior capsule .
METHODS	In group II ( n = 38 ) , capsular release was extended to the posterior capsule .
METHODS	The American Shoulder and Elbow Surgeons score , Simple Shoulder Test , visual analog scale for pain , and range of motion ( ROM ) were used for the evaluation before surgery and at 3 , 6 , and 12 months after surgery and at the last follow-up .
RESULTS	Preoperative demographic data of age , sex , symptom duration , and clinical outcomes showed no significant differences ( P > .05 ) .
RESULTS	The average follow-up was 18.4 months .
RESULTS	Both groups showed significantly increased ROM at the last follow-up compared with preoperative ROM ( P < .05 ) .
RESULTS	At the last follow-up , no statistical differences were found ( P > .05 ) between groups I and II in American Shoulder and Elbow Surgeons score ( 91.3 vs. 79.5 ) , Simple Shoulder Test ( 83.3 vs. 83.3 ) , and visual analog scale ( 1.5 vs. 2.2 ) .
RESULTS	There were also no statistical differences between the 2 groups at the last follow-up ( P > .05 ) in ROM : forward flexion , 145.2 vs. 143.3 ; external rotation with 90 of abduction , 88.1 vs. 86.2 ; external rotation at side , 88.9 vs. 82.9 ; and internal rotation , 9.1 vs. 8.3 .
CONCLUSIONS	Posterior extended capsular release might not be necessary in arthroscopic surgery for shoulder stiffness .

###26087214
OBJECTIVE	The aim of this study is to compare quality of life in 3-month follow-up after the use of transobturator tape TVT-O and single incision tape AJUST in the treatment of urodynamic stress urinary incontinence ( USI ) .
METHODS	Randomized trial .
METHODS	Gynekologicko-porodnick klinika LF UK a FN Plze , Gynekologicko-porodnick klinika 1 .
METHODS	LF UK a VFN Praha .
METHODS	Between May 2010 and May 2012 100 women with proven urodynamic stress urinary incontinence were included in this randomized trial .
METHODS	These patients were randomly chosen and devided into two group : 50 patients for TVT-O procedure and 50 patients for AJUST procedure .
METHODS	All of the patients underwent a complete urogynecological examination prior to the actual procedure ( clinical examination , urodynamic examination , ultrasound examination ) and filled in ICIQ-SF and iQol questionnaires .
METHODS	After the surgery , the patients satisfaction was evaluated by visual analoque scale ( VAS ) and Likert scale and by ICIQ-SF and iQol questionnaires .
METHODS	The intensity and length of postoperative pain was monitored using the visual analogue scale .
METHODS	The patients underwent an examination after 3 months .
RESULTS	In both groups of participants no significant differences regarding age , BMI , parity , history of surgery for gynecological disorders , were found .
RESULTS	Preoperative urodynamic , ICIQ-SF and iQol parameters were also not significantly different .
RESULTS	In the 3-month follow-up 48 participants from TVT-O group and 50 participants from the AJUST group were monitored .
RESULTS	No statistically significant differences in subjective and objective parameters were found .
RESULTS	Subjectively stress incontinence was not present in 97.9 % in the TVT-O and 96.0 % in the group AJUST .
RESULTS	Objectively stress test was negative in 93.8 % in the TVT-O and 94 % in group AJUST .
RESULTS	By evaluating the ICIQ and iQol were found no statistical differences in the quality of life in both operating groups .
CONCLUSIONS	At 3-months follow up we did not find any statistical difference between subjective and objective outcome for single incision tape AJUST and TVT-O .
CONCLUSIONS	In the AJUST group lower intensity and shorter duration of postoperative pain were observed .

###24502830
BACKGROUND	Patients who develop relapsing-remitting multiple sclerosis ( MS ) present with a first clinical demyelinating event .
BACKGROUND	In this double-blind , multicentre , randomised , phase 3 study we investigated the effect of oral cladribine on conversion to clinically definite MS in patients with a first clinical demyelinating event , when given at the same doses shown to be effective in relapsing-remitting MS.
METHODS	Between Oct 21 , 2008 , and Oct 11 , 2010 , we recruited patients aged 18-55 years , inclusive , from 160 hospitals , private clinics , or treatment centres in 34 countries .
METHODS	Eligible patients had a first clinical demyelinating event within 75 days before screening , at least two clinically silent lesions of at least 3 mm on a T2-weighted brain MRI scan , and an Expanded Disability Status Scale score of 5.0 or lower .
METHODS	Patients with a first clinical demyelinating event 75 days before screening were randomly assigned ( 1:1:1 ) to receive cladribine tablets at cumulative doses of 5.25 mg/kg or 3.5 mg/kg or placebo .
METHODS	Randomisation was done with a central web-based randomisation system and was stratified by geographic region .
METHODS	Masking was maintained using a two-physician model .
METHODS	The primary endpoint of this 96-week study was time to conversion to clinically definite MS according to the Poser criteria .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00725985 .
RESULTS	Of 903 participants assessed for eligibility , 616 patients received cladribine 5.25 mg/kg ( n = 204 ) , cladribine 3.5 mg/kg ( n = 206 ) , or placebo ( n = 206 ) .
RESULTS	At trial termination on Oct 25 , 2011 , cladribine was associated with a risk reduction versus placebo for time to conversion to clinically definite MS ( hazard ratio [ HR ] for 5.25 mg/kg = 0.38 , 95 % CI 0.25-0 .58 , p < 0.0001 ; HR for 3.5 mg/kg = 0.33 , 0.21-0 .51 , p < 0.0001 ) .
RESULTS	Adverse events were reported in 165 ( 81 % ) patients in the cladribine 5.25 mg/kg group , 168 ( 82 % ) patients in the cladribine 3.5 mg/kg group , and 162 ( 79 % ) patients in the placebo group .
RESULTS	We noted no increase in risk of adverse events with active treatment versus placebo apart from lymphopenia , which was a severe event in 10 ( 5 % ) patients in the 5.25 mg/kg group and four ( 2 % ) patients in the 3.5 mg/kg group .
CONCLUSIONS	Both doses of cladribine significantly delayed MS diagnosis compared with placebo .
CONCLUSIONS	The safety profile of cladribine was similar to that noted in a trial in patients with relapsing-remitting MS. Further research could clarify the potential effects of oral cladribine treatment in the early stages of MS.
BACKGROUND	Merck Serono SA Geneva , a subsidiary of Merck KGaA , Darmstadt , Germany .

###24257892
OBJECTIVE	The aim of this work was to study the reduction in intraocular pressure ( IOP ) after two selective laser trabeculoplasty ( SLT ) treatments in the same area of the trabecular meshwork ( TM ) compared to two SLT treatments in two different areas of the TM when the initial SLT treatment has failed .
METHODS	This was a prospective randomized clinical trial for testing the effect of repeated SLT treatments in reducing IOP .
METHODS	The patients in the study all suffered from primary open-angle or pseudoexfoliation glaucoma .
METHODS	All patients were treated initially with SLT ( SLT 1 ) over 180 in the lower half of the TM .
METHODS	Patients who were chosen for retreatment with SLT ( SLT 2 ) were asked to participate in the study .
METHODS	The patients in the study were randomized to either SLT 2 in the same , already-treated TM area or to SLT 2 in the upper untreated TM area .
METHODS	The IOP was measured before and 2h , 1month , 3months , and 6months after the SLT 2 treatment .
METHODS	Patients who changed medical therapy regimens during this time were excluded .
RESULTS	A total of 40 patients were included in both groups .
RESULTS	At baseline , there were no significant differences between the groups in regards to age ( t-test , p = 0.44 ) , gender ( ( 2 ) , p = 0.14 ) , pseudoexfoliation glaucoma ( ( 2 ) , p = 0.07 ) , time between SLT 1 and SLT 2 ( t-test , p = 0.78 ) , IOP before SLT 1 ( t-test , p = 0.78 ) , or IOP before SLT 2 ( t-test , p = 0.32 ) .
RESULTS	At the conclusion of the study , there were no significant differences in IOP between the groups 2h ( t-test , p = 0.65 ) , 1month ( t-test , p = 0.60 ) , 3months ( t-test , p = 0.42 ) , or 6months ( t-test , p = 0.66 ) after the SLT 2 treatment .
CONCLUSIONS	Two SLT treatments of the same TM area do not have a significant effect on IOP compared to two SLT treatments in two different areas .

###24664811
OBJECTIVE	Using the database of the National Institute of Mental Health-sponsored acute treatment of late life mania study ( GERI-BD ) , we assessed the role of social support in the presentation of late life bipolar mania .
METHODS	In the first 100 subjects randomized in geriatric BD , we explored the demographic , clinical , and social support characteristics ( assessed using the Duke Social Support Index ) and aspects of manic presentation .
METHODS	We selected two dependent variables : symptom severity , as determined by the Young Mania Rating Scale ( YMRS ) at baseline , and duration of episode .
METHODS	We selected nine potential independent variables on the basis of Pearson correlation coefficients .
METHODS	We derived two final models using multiple regression analysis employing an iterative process .
RESULTS	In our severity model , being married was associated with a higher YMRS score ( p = 0.05 ) , whereas higher social interaction scores with non-family members were associated with a lower YMRS score ( p = 0.011 ) .
RESULTS	In the episode duration model , longer duration was associated with a higher Hamilton Depression Rating Scale score ( p = 0.03 ) and higher social interaction scores with non-family members ( p = 0.0003 ) , younger age ( p = 0.04 ) , higher number of persons in one 's family social network ( p = 0.017 ) , and higher instrumental support scores ( p = 0.0062 ) .
CONCLUSIONS	In late life mania , more social interaction with one 's community appears to be associated with less severe symptoms at presentation for treatment , however , it can also be associated with slightly longer the duration of episode .
CONCLUSIONS	Two aspects of the Duke Social Support Index are associated with a shorter episode duration prior to seeking treatment : being part of a larger family network and a having a higher level of instrumental support prior to treatment .
CONCLUSIONS	The Instrumental Support Subscale measures the degree of assistance that is available for the respondent in performing daily tasks .
CONCLUSIONS	These findings suggest that in older adults with BD , close social interactions and support are important in limiting the length of the illness episode prior to treatment .
CONCLUSIONS	Social interactions involving non-family members may be less important in moderating the intensity of the symptoms at presentation .

###25766269
OBJECTIVE	To determine the efficacy of brief Culturally adapted CBT ( CaCBT ) for depression when added to Treatment As usual ( TAU ) - delivered by trained therapists using a manual compared with alone TAU .
METHODS	This was an assessor-blinded , randomised controlled clinical trial .
METHODS	Particpants with a diagnosis of depression , attending psychiatry departments of three teaching hospitals in Lahore , Pakistan , were included in the study .
METHODS	We screened a total of 280 patients and randomly allocated 137 of them to CaCBT plus Treatment As Usual ( TAU ) [ Treatment group ] or to TAU alone [ Control group ] .
METHODS	Assessments were completed at baseline , at 3 months and at 9 months after baseline .
METHODS	Reduction in depression score ( Hospital Anxiety and Depression-Depression Subscale ) at 3 months was primary outcome measure .
METHODS	The secondary outcome measures included anxiety scores ( Hospital Anxiety and Depression-Anxiety Subscale ) , somatic symptoms ( Bradford Somatic Inventory ) , disability ( Brief Disability Questionnaire ) and satisfaction with the treatment .
RESULTS	A total of 69 participants were randomised to Treatment group and 68 to Control group .
RESULTS	Participants in Treatment group showed statistically significant improvement in depression ( p = 0.000 ) , anxiety ( p = 0.000 ) , somatic symptoms ( p = 0.005 ) and disability ( p = 0.000 ) .
RESULTS	This effect was sustained at 9 months after baseline ( Except for disability ) .
RESULTS	Participants in Treatment group also reported higher satisfaction with treatment compared with those in Control group .
CONCLUSIONS	Brief CaCBT can be effective in improving depressive symptoms , when compared with treatment as usual .
CONCLUSIONS	This is the first report of a trial of Culturally adapted CBT from South Asia and further studies are needed to generalise these findings .

###25092938
OBJECTIVE	Interactive voice response systems integrated with electronic health records have the potential to improve primary care by engaging parents outside clinical settings via spoken language .
OBJECTIVE	The objective of this study was to determine whether use of an interactive voice response system , the Personal Health Partner ( PHP ) , before routine health care maintenance visits could improve the quality of primary care visits and be well accepted by parents and clinicians .
METHODS	English-speaking parents of children aged 4 months to 11 years called PHP before routine visits and were randomly assigned to groups by the system at the time of the call .
METHODS	Parents ' spoken responses were used to provide tailored counseling and support goal setting for the upcoming visit .
METHODS	Data were transferred to the electronic health records for review during visits .
METHODS	The study occurred in an urban hospital-based pediatric primary care center .
METHODS	Participants were called after the visit to assess ( 1 ) comprehensiveness of screening and counseling , ( 2 ) assessment of medications and their management , and ( 3 ) parent and clinician satisfaction .
RESULTS	PHP was able to identify and counsel in multiple areas .
RESULTS	A total of 9.7 % of parents responded to the mailed invitation .
RESULTS	Intervention parents were more likely to report discussing important issues such as depression ( 42.6 % vs 25.4 % ; P < .01 ) and prescription medication use ( 85.7 % vs 72.6 % ; P = .04 ) and to report being better prepared for visits .
RESULTS	One hundred percent of clinicians reported that PHP improved the quality of their care .
CONCLUSIONS	Systems like PHP have the potential to improve clinical screening , counseling , and medication management .

###25627152
METHODS	Secondary exploratory analysis of a randomized controlled trial comparing supervised exercise therapy to usual care in patients with patellofemoral pain ( PFP ) .
OBJECTIVE	To explore which patients with PFP are more likely to benefit from exercise therapy .
BACKGROUND	Patellofemoral pain is a common condition for which exercise therapy is effective in reducing pain and improving function .
BACKGROUND	However , not all patients benefit from exercise therapy .
METHODS	The present study explored patient characteristics that might interact with treatment effects of PFP in 131 patients treated with usual care or exercise therapy .
METHODS	These characteristics were tested for interaction with treatment in a regression analysis .
METHODS	The primary outcomes were function and pain on activity at a 3-month follow-up .
RESULTS	None of the tested variables had a significant interaction with treatment .
RESULTS	A positive trend was seen for females with PFP : they were more likely to report higher function scores with exercise therapy than with usual care compared to males with PFP ( = 12.1 ; 95 % confidence interval : 0.23 , 24.0 ; P = .05 ) .
RESULTS	A positive trend was seen for patients with a longer duration of complaints ( greater than 6 months ) ; they were more likely to report higher function scores and to have less pain on activity with exercise therapy than with usual care compared to those with a shorter duration of complaints ( = 12.3 ; 95 % confidence interval : -0.08 , 24.7 ; P = .05 and = -1.74 ; 95 % confidence interval : -3.90 , 0.43 ; P = .12 , respectively ) .
CONCLUSIONS	Two factors , sex and duration of complaints , may have a predictive value for response to exercise therapy at 3-month follow-up .
CONCLUSIONS	Due to the exploratory design of the study , future research should confirm this tendency .

###25151662
BACKGROUND	Tobacco use is epidemic among persons living with HIV ( PLWH ) , and several studies have shown self-efficacy ( SE ) to be a predictor of successful cessation .
BACKGROUND	This study examined sociobehavioral correlates of SE and its predictive value for successful cessation in a group of PLWH smokers .
METHODS	The study was conducted on combined patient data from 2 separate randomized controlled trials of tobacco treatment for PLWH smokers .
METHODS	Both trials utilized the same SE scale at the same timepoints , and both had the same smoking cessation endpoint ( biochemically confirmed , 7-day , point prevalence abstinence at 3 months ) .
METHODS	Univariate and multivariate techniques were used to analyze the merged dataset .
RESULTS	Baseline SE data were available for 272 subjects .
RESULTS	The Self-Efficacy/Temptations Scale-Long Form demonstrated good internal reliability with overall and subscale Cronbach 's alpha of .77 -.92 .
RESULTS	Younger age , HIV risk other than injection drug use , recent alcohol use , and higher scores for anxiety , depression , loneliness , and nicotine dependence were all significantly correlated with lower baseline SE .
RESULTS	Posttreatment SE was significantly predictive of successful cessation , whereas baseline SE was not .
RESULTS	Subjects randomized to the treatment interventions were significantly more likely to quit ( AOR = 2.99 [ 1.26-7 .01 ] , p = .01 ) , and logistic regression suggested a possible mediating effect of posttreatment SE .
CONCLUSIONS	SE is tightly correlated with a number of modifiable affective and behavioral factors in PLWH smokers , and measures aimed at increasing the SE to abstain in such individuals may enhance the effect of targeted tobacco treatment strategies .

###25004184
OBJECTIVE	In this study , we assessed the efficacy of 2 pharmacodynamically different antidepressants , citalopram ( a selective serotonin reuptake inhibitor ) and reboxetine ( a norepinephrine reuptake inhibitor ) , as adjunctive therapy to risperidone and olanzapine for the treatment of negative symptoms in schizophrenia .
METHODS	We performed a 6-month , multicenter , double-blind , randomized , placebo-controlled clinical trial .
METHODS	The recruitment period was from November 2008 to December 2011 .
METHODS	The sample comprised 90 patients with a diagnosis of schizophrenia ( DSM-IV criteria ) who exhibited negative symptoms .
METHODS	The patients were recruited from 10 centers in different cities of the Spanish State .
METHODS	The primary efficacy measure was change in score on the negative subscale of the Positive and Negative Syndrome Scale ( PANSS ) between baseline and 6-month assessment .
METHODS	Other efficacy measures were changes in the PANSS subscales and total score , as well as the Scale for the Assessment of Negative Symptoms ( SANS ) subscales and total score .
RESULTS	For statistical analysis , we employed mixed-effects models .
RESULTS	We did not find statistically significant differences between the placebo group and the 2 treatment groups at 6-month assessments for the PANSS total ( P = .6511 ) , any PANSS subscale ( negative [ P = .5533 ] , positive [ P = .1723 ] , or general psychopathology [ P = .2083 ] ) , or the SANS ( P = .5884 ) .
RESULTS	Cohen d measure showed a small effect size below the 0.5 threshold for all comparisons .
CONCLUSIONS	In conclusion , our results do not support adjunctive use of citalopram or reboxetine with risperidone or olanzapine for the treatment of negative symptoms in schizophrenia .
BACKGROUND	ClinicalTrials.gov identifier : NCT01300364 .

###24831252
BACKGROUND	It has been found that mask style can affect the amount of continuous positive airway pressure ( CPAP ) required to reduce an apnoea/hyponoea index ( AHI ) to < 5/h on a titration study .
BACKGROUND	However , it was not previously known whether switching from one CPAP mask style to another post titration could affect the residual AHI with CPAP .
BACKGROUND	The purpose of this study was to investigate the differences in residual AHI with CPAP treatment between oronasal and nasal masks .
METHODS	Twenty-one subjects ( age mean ( M ) = 62.9 , body mass index ( BMI ) M = 29.6 kg/m2 ) were randomised ( 14 subjects completed the protocol ) to undergo an in-laboratory CPAP titration with either a nasal mask or an oronasal mask .
METHODS	Subjects were then assigned this mask for 3weeks of at-home CPAP use with the optimal treatment pressure determined on the laboratory study ( CPAP M = 8.4 cm of H2O ) .
METHODS	At the end of this 3-week period , data were collected from the CPAP machine and the subject was given the other mask to use with the same CPAP settings for the next 3weeks at home ( if the nasal mask was given initially , the oronasal one was given later and vice versa ) .
METHODS	On completion of the second 3-week period , data on residual AHI were again collected and compared with the first 3-week period on CPAP .
RESULTS	A Wilcoxon Signed-Rank Test ( two-tailed ) revealed that residual AHI with CPAP treatment was significantly higher with the oronasal compared with the nasal mask ( z = -3.296 , p < 0.001 ) .
RESULTS	All 14 subjects had a higher residual AHI with the oronasal versus nasal mask , and 50 % of the subjects had a residual AHI > 10/h in the oronasal mask condition , even though all of these subjects were titrated to an AHI of < 5/h in the laboratory .
CONCLUSIONS	A higher residual AHI was seen in all patients with the use of an oronasal mask compared with a nasal mask .
CONCLUSIONS	Switching to an oronasal mask post titration results in an increase in residual AHI with CPAP treatment , and pressure adjustment may be warranted .

###25053420
OBJECTIVE	To report on risk factors for severe events ( hospitalisation or infant death ) within the first half of infancy amongst HIV-unexposed infants in South Africa .
METHODS	South African data from the multisite community-based cluster-randomised trial PROMISE EBF promoting exclusive breastfeeding in three sub-Saharan countries from 2006 to 2008 were used .
METHODS	The South African sites were Paarl in the Western Cape Province , and Umlazi and Rietvlei in KwaZulu-Natal .
METHODS	This analysis included 964 HIV-negative mother-infant pairs .
METHODS	Data on severe events and infant feeding practices were collected at 3 , 6 , 12 and 24 weeks post-partum .
METHODS	We used a stratified extended Cox model to examine the association between the time to the severe event and covariates including birthweight , with breastfeeding status as a time-dependent covariate .
RESULTS	Seventy infants ( 7 % ) experienced a severe event .
RESULTS	The median age at first hospitalisation was 8 weeks , and the two main reasons for hospitalisation were cough and difficult breathing followed by diarrhoea .
RESULTS	Stopping breastfeeding before 6 months ( HR 2.4 ; 95 % CI 1.2-5 .1 ) and low birthweight ( HR 2.4 ; 95 % CI 1.3-4 .3 ) were found to increase the risk of a severe event , whilst maternal completion of high school education was protective ( HR 0.3 ; 95 % CI 0.1-0 .7 ) .
CONCLUSIONS	A strengthened primary healthcare system incorporating promotion of breastfeeding and appropriate caring practices for low birthweight infants ( such as kangaroo mother care ) are critical .
CONCLUSIONS	Given the leading reasons for hospitalisation , early administration of oral rehydration therapy and treatment of suspected pneumonia are key interventions needed to prevent hospitalisation in young infants .

###24251693
BACKGROUND	As histopathologic assessment is subject to sampling error , some institutions ` preorder ' deeper sections on some or all cases ( hereafter referred to as prospective deeper sections ) , while others order additional sections only when needed ( hereafter referred to as retrospective deeper sections ) .
BACKGROUND	We investigated how often additional sections changed a diagnosis and/or clinical management .
BACKGROUND	Given the recent decrease in reimbursement for CPT-code 88305 , we also considered the financial implications of ordering additional sections .
METHODS	Cases ( n = 204 ) were assigned a preliminary diagnosis , based on review of the initial slide , and a final diagnosis , after reviewing additional sections .
METHODS	Cases with discordant diagnoses were assessed by two dermatologists , who indicated whether the change in diagnosis altered clinical management .
METHODS	Expenses were estimated for three scenarios : ( a ) no additional sections , ( b ) prospective deeper sections and ( c ) retrospective deeper sections .
RESULTS	Diagnoses were modified in 9 % of cases , which changed clinical management in 56 % of these cases .
RESULTS	Lesions obtained by punch-biopsy and inflammatory lesions were disproportionately overrepresented amongst cases with changed diagnoses ( p < 0.001 , p = 0.12 , respectively ) .
RESULTS	The cost of prospective deeper sections and retrospective deeper sections represented a 56 % and 115 % increase over base costs , respectively .
RESULTS	Labor costs , particularly the cost of dermatopathologist evaluation , were the most significant cost-drivers .
CONCLUSIONS	While additional sections improve diagnostic accuracy , they delay turn-around-time and increase expenditures .
CONCLUSIONS	In our practice , prospective deeper sections are cost effective , however , this may vary by institution .

###25530364
OBJECTIVE	To evaluate the role of 2 different -1 blockers and 1 phosphodiesterase-5 inhibitor as medical expulsive therapy for distal ureteric calculi .
METHODS	Between January 2011 and December 2012 , 285 patients presenting with distal ureteric stones of size 5-10 mm were on consent randomly assigned to 1 of 3 outpatient treatment arms : tamsulosin ( group A ) , silodosin ( group B ) , and tadalafil ( group C ) .
METHODS	Therapy was given for a maximum of 4 weeks .
METHODS	Stone expulsion rate , time to stone expulsion , analgesic use , number of hospital visits for pain , follow-up , and endoscopic treatment and adverse effects of drugs were noted .
METHODS	All 3 groups were compared for normally distributed data by the analysis of variance , Bonferroni or Kruskal-Wallis test , and Mann-Whitney U test , as required .
METHODS	All the classified and categorical data were analyzed for all 3 groups by using the chi-square test .
RESULTS	There was a statistically significant expulsion rate of 83.3 % in group B compared with 64.4 % and 66.7 % in groups A and C , respectively , with lower time of stone expulsion ( P value = .006 and P value = .016 , respectively ) .
RESULTS	Statistically significant differences were noted in colicky episodes and analgesic requirement in group B than groups A and C.
RESULTS	There was no serious adverse event .
CONCLUSIONS	Medical expulsive therapy for the distal ureteric stones using tamsulosin , silodosin , and tadalafil is safe , efficacious , and well tolerated .
CONCLUSIONS	The result of this pilot study showed that silodosin increases ureteric stone expulsion quite significantly along with better control of pain with significantly lesser analgesic requirement .

###25688780
OBJECTIVE	Some cigarette smokers may not be ready to quit immediately but may be willing to reduce cigarette consumption with the goal of quitting .
OBJECTIVE	To determine the efficacy and safety of varenicline for increasing smoking abstinence rates through smoking reduction .
METHODS	Randomized , double-blind , placebo-controlled , multinational clinical trial with a 24-week treatment period and 28-week follow-up conducted between July 2011 and July 2013 at 61 centers in 10 countries .
METHODS	The 1510 participants were cigarette smokers who were not willing or able to quit smoking within the next month but willing to reduce smoking and make a quit attempt within the next 3 months .
METHODS	Participants were recruited through advertising .
METHODS	Twenty-four weeks of varenicline titrated to 1 mg twice daily or placebo with a reduction target of 50 % or more in number of cigarettes smoked by 4 weeks , 75 % or more by 8 weeks , and a quit attempt by 12 weeks .
METHODS	Primary efficacy end point was carbon monoxide-confirmed self-reported abstinence during weeks 15 through 24 .
METHODS	Secondary outcomes were carbon monoxide-confirmed self-reported abstinence for weeks 21 through 24 and weeks 21 through 52 .
RESULTS	The varenicline group ( n = 760 ) had significantly higher continuous abstinence rates during weeks 15 through 24 vs the placebo group ( n = 750 ) ( 32.1 % for the varenicline group vs 6.9 % for the placebo group ; risk difference ( RD ) , 25.2 % [ 95 % CI , 21.4 % -29.0 % ] ; relative risk ( RR ) , 4.6 [ 95 % CI , 3.5-6 .1 ] ) .
RESULTS	The varenicline group had significantly higher continuous abstinence rates vs the placebo group during weeks 21 through 24 ( 37.8 % for the varenicline group vs 12.5 % for the placebo group ; RD , 25.2 % [ 95 % CI , 21.1 % -29.4 % ] ; RR , 3.0 [ 95 % CI , 2.4-3 .7 ] ) and weeks 21 through 52 ( 27.0 % for the varenicline group vs 9.9 % for the placebo group ; RD , 17.1 % [ 95 % CI , 13.3 % -20.9 % ] ; RR , 2.7 [ 95 % CI , 2.1-3 .5 ] ) .
RESULTS	Serious adverse events occurred in 3.7 % of the varenicline group and 2.2 % of the placebo group ( P = .07 ) .
CONCLUSIONS	Among cigarette smokers not willing or able to quit within the next month but willing to reduce cigarette consumption and make a quit attempt at 3 months , use of varenicline for 24 weeks compared with placebo significantly increased smoking cessation rates at the end of treatment , and also at 1 year .
CONCLUSIONS	Varenicline offers a treatment option for smokers whose needs are not addressed by clinical guidelines recommending abrupt smoking cessation .
BACKGROUND	clinicaltrials.gov Identifier : NCT01370356 .

###25219207
OBJECTIVE	To investigate the application and the clinical effect of nasal endoscope in styloid process truncating operation .
METHODS	Dividing 66 patients into nasal endoscope group and control group randomly , and then observe them .
METHODS	Nasal endoscope group were cured with nasal endoscope during the styloid process truncating operation and the control group were treated with the routine method of intraoral path .
METHODS	All the operations were executed by the same person .
METHODS	Observation index included the following aspects : the length of the truncated styloid process , the operation time , intraoperative bleeding , postoperative pain and pain degree , inflammatory reaction of raw surface and rehaemorrhagia .
RESULTS	Compared with the control group , the length of the truncated styloid process of nasal endoscope group were longer and the operation time had no significant differences .
RESULTS	The intraoperative bleeding of intraoperative bleeding group were ( 85.0 + / - 35.0 ) ml and in control group were ( 95.0 + / - 40.0 ) ml .
RESULTS	There are no significant differences between the result .
RESULTS	Nasal endoscope group also had the advantages of fewer aches and less inflammatory reaction of raw surface .
RESULTS	Both of the team had no rehaemorrhagia .
CONCLUSIONS	nasal endoscope can truncate a longer styloid process in styloid process truncating operation and is effective to relieve pain , and ease inflammatory reaction , it 's a safe mini-trauma operation .

###24308613
BACKGROUND	I.v. 0.9 % sodium chloride ( normal saline ) is frequently used to treat ED patients with acute alcohol intoxication despite the lack of evidence for its efficacy .
OBJECTIVE	The study aims to compare treatment with i.v. normal saline and observation with observation alone in ED patients with acute alcohol intoxication .
METHODS	A single-blind , randomised , controlled trial was conducted to compare a single bolus of 20 mL/kg i.v. normal saline plus observation with observation alone .
METHODS	One hundred and forty-four ED patients with uncomplicated acute alcohol intoxication were included .
METHODS	The study was conducted in one tertiary and one urban ED in Queensland , Australia .
METHODS	Primary outcome was ED length of stay ( EDLOS ) .
METHODS	Secondary outcomes were treatment time , breath alcohol levels , intoxication symptom score , level of intoxication and associated healthcare costs .
RESULTS	Both groups were comparable at baseline : blood alcohol content ( BAC ) was similar between treatment and control groups ( 0.20 % BAC vs 0.19 % BAC , P = 0.44 ) as were initial intoxication symptom scores ( 22.0 vs 22.3 , P = 0.90 ) .
RESULTS	Both groups had a similar EDLOS ( 287 min vs 274 min , P = 0.89 ; difference 13 min [ 95 % CI -37 -63 ] ) and treatment time ( 244 min vs 232 min , P = 0.94 ; difference 12 min [ 95 % CI -31 -55 ] ) .
RESULTS	Change of breath alcohol levels , intoxication score and level of intoxication were not significantly different between the two groups .
RESULTS	Patients in the treatment group had an additional healthcare cost of A$ 31.92 compared with control .
CONCLUSIONS	I.v. normal saline therapy added to observation alone does not decrease ED length of stay compared with observation alone .
CONCLUSIONS	Intoxication symptom scores and general state of intoxication were similar in both groups .
CONCLUSIONS	The present study suggests that either approach is reasonable , but observation alone might be preferred as it is less resource intensive .

###25007865
BACKGROUND	Inhaled corticosteroids are a mainstay of therapy for persistent asthma , but suboptimal adherence with twice-daily use is widespread .
BACKGROUND	Fluticasone furoate ( FF ) is a new inhaled corticosteroid ( ICS ) suitable for once-daily dosing in asthma .
BACKGROUND	This study was performed to descriptively assess the efficacy and safety of two doses of FF , with no planned formal statistical hypothesis testing .
METHODS	This was a 24-week double-blind , multicentre , parallel-group study ( NCT01431950 ) .
METHODS	Patients aged 12 years with moderate-severe persistent asthma and uncontrolled on mid-high dose ICS were stratified by baseline FEV1 and randomised ( 1:1 ) to treatment with FF 100 g or 200 g once daily in the evening .
METHODS	The primary endpoint was change from baseline trough FEV1 after 24 weeks ; secondary and other endpoints included peak expiratory flow ( PEF ) and rescue-free and symptom-free 24-hour periods over Weeks 1-24 , and Asthma Control Test ( ACT ) score at Week 24 .
METHODS	A pre-specified subgroup analysis of patients by randomisation strata was performed for the primary and selected secondary and other endpoints .
METHODS	Safety assessments included adverse events , laboratory and vital sign measurements , and change from baseline in 24-hour urinary cortisol at Week 24 .
RESULTS	With FF 100 g and 200 g , least squares mean trough FEV1 improved from baseline by 208 mL and 284 mL , respectively , at Week 24 ; treatment difference : 77 mL ( 95 % CI : -39 , 192 ) .
RESULTS	Similar improvements from baseline in rescue - and symptom-free periods , and morning and evening PEF were observed in both groups .
RESULTS	Patients were 42 % more likely to be well-controlled ( ACT score 20 ) with FF 200 g than with FF 100 g. Slightly more patients receiving FF 200 g vs. FF 100 g reported adverse events ( 63 % vs. 59 % ) and events deemed treatment related ( 5 % vs. < 1 % ) .
RESULTS	Seven serious adverse events ( FF 200 g 4 ; FF 100 g 3 ) were reported , none of which were deemed treatment related .
RESULTS	No clinically relevant effects of either dose on 24-hour urinary cortisol were observed .
CONCLUSIONS	Improvements from baseline in trough FEV1 were observed after 24 weeks of treatment with both doses of FF , with a numerically greater improvement in FEV1 observed in patients receiving FF 200 g. Secondary endpoint findings were similar between groups .
CONCLUSIONS	No safety concerns were identified during the study .

###24966134
BACKGROUND	This study evaluated the effectiveness of a school-community program on Health-Related Quality of Life ( HRQoL ; the primary outcome ) , physical activity ( PA ) , and potential mediators of PA among adolescent girls living in low-socioeconomic rural/regional settings .
METHODS	The study was a cluster-randomized controlled trial .
METHODS	Twelve communities with the requisite sports clubs and facilities were paired according to relevant criteria ; one of each pair was randomly assigned to the intervention or control condition .
METHODS	Eight schools per condition were randomly selected from these communities and the intervention was conducted over one school year ( 2011 ) .
METHODS	Female students in grades 7-9 in intervention schools participated in two 6-session PA units - a sport unit ( football or tennis ) and a recreational unit ( leisure centre-based ) .
METHODS	These were incorporated into physical education ( PE ) curriculum and linked to PA opportunities for participation outside school .
METHODS	Students were surveyed at baseline and endpoint , self-reporting impact on primary and secondary outcome measures ( HRQoL , PA ) and PA mediators ( e.g. self-efficacy ) .
METHODS	Linear mixed models for two-group ( intervention , control ) and three-group ( completers , non-completers , control ) analyses were conducted with baseline value , age and BMI as covariates , group as a fixed effect and school as random cluster effect .
RESULTS	Participants completing baseline and endpoint measures included : 358 intervention ( baseline response rate 33.7 % , retention rate 61.3 % ) and 256 control ( 14.1 % and 84.0 % ) .
RESULTS	Adjustment for age and BMI made no substantive difference to outcomes , and there were no cluster effects .
RESULTS	For HRQoL , after adjustment for baseline scores , the intervention group showed significantly higher scores on all three PedsQL scores ( physical functioning : MSE = 83.90.7 , p = .005 ; psychosocial : 79.90.8 , p = .001 ; total score : 81.30.7 , p = .001 ) than the control group ( 80.90.8 ; 76.10.9 and 77.80.8 ) .
RESULTS	The three-group analysis found intervention non-completers had significantly higher PedsQL scores ( 84.00.8 , p = .021 ; 80.40.9 , p = .003 ; 81.70.8 , p = .002 ;) than controls ( 80.90.8 , 76.10.9 and 77.80.8 ) .
RESULTS	There were no significant differences for any PA measure .
RESULTS	Intervention completers had significantly higher scores than non-completers and controls for some mediator variables ( e.g. self-efficacy , behavioural control ) .
CONCLUSIONS	Positive outcomes were achieved from a modest school-community linked intervention .
CONCLUSIONS	The school component contributed to maintaining HRQoL ; students who completed the community component derived a range of intra-personal and inter-personal benefits .
BACKGROUND	ACTRN12614000446662 .
BACKGROUND	April 30th 2014 .

###25200141
OBJECTIVE	This study examined the effects of moderate renal impairment on the pharmacokinetics and pharmacodynamics of canagliflozin in Japanese patients with type 2 diabetes mellitus .
METHODS	Japanese patients with stable type 2 diabetes ( 12 with moderate renal impairment and 12 with normal renal function or mild renal impairment ) were eligible .
METHODS	This was an open-label , randomized , two-way crossover , two-sequence , single-dose study performed at a single center in Japan .
METHODS	The subjects were hospitalized for the pharmacodynamic/pharmacokinetic evaluations .
METHODS	Twenty-four patients received a single dose each of canagliflozin 100 and 200 mg before breakfast in a crossover manner with a 14-day washout between doses .
METHODS	The main outcome measures were pharmacokinetics of canagliflozin and its main metabolites ( M5 and M7 ) in plasma and urine , and change from baseline in 24-h urinary glucose excretion ( UGE24 h ) .
RESULTS	There was no significant effect of moderate renal impairment on the maximum canagliflozin concentration .
RESULTS	The ratios of least square means ( 90 % confidence intervals [ CIs ] ) of moderate renal impairment relative to normal renal function or mild renal impairment were 0.982 ( 0.821-1 .173 ) and 0.989 ( 0.827-1 .182 ) for the 100 and 200 mg doses , respectively .
RESULTS	The canagliflozin area under the plasma concentration-time curve was greater in those with moderate renal impairment than in those without , after both canagliflozin doses ( ratio of least square means [ 90 % CI ] 1.258 [ 1.061-1 .490 ] and 1.216 [ 1.026-1 .441 ] ) .
RESULTS	UGE24 h increased after administration of both doses , but in patients with moderate renal impairment , the increase was approximately 70 % of that in patients with normal renal function or mild renal impairment .
RESULTS	The incidence of adverse events was low and no patient developed hypoglycemia .
CONCLUSIONS	The pharmacokinetics of canagliflozin are affected by renal function , with slight decreases in renal clearance observed .
CONCLUSIONS	No effect of renal impairment on the maximum concentration was observed .
CONCLUSIONS	Renal impairment reduced the ability of canagliflozin to promote urinary glucose excretion .

###24965700
OBJECTIVE	This study evaluated the efficacy and safety of canagliflozin , a sodium glucose co-transporter 2 inhibitor , in patients with type 2 diabetes mellitus ( T2DM ) and within a subset of Stage 3 chronic kidney disease ( CKD ; estimated glomerular filtration rate [ eGFR ] 30 and < 50 ml/min/1 .73 m ( 2 ) ) .
METHODS	In this 52-week , randomized , double-blind , placebo-controlled study , patients ( N = 269 ; mean eGFR , 39.4 ml/min/1 .73 m ( 2 ) ) received canagliflozin 100 or 300 mg and placebo once daily .
METHODS	Efficacy endpoints included changes in glycated haemoglobin ( HbA1c ) , fasting plasma glucose ( FPG ) , body weight and systolic blood pressure ( BP ) ; adverse events ( AEs ) were also recorded .
RESULTS	At week 52 , canagliflozin 100 and 300 mg reduced HbA1c compared with placebo ( -0.19 , -0.33 and 0.07 % , respectively ) ; placebo-subtracted differences ( 95 % confidence interval ) were -0.27 % ( -0.53 , 0.001 ) and -0.41 % ( -0.68 , -0.14 ) .
RESULTS	Canagliflozin also lowered FPG , body weight and BP versus placebo .
RESULTS	Overall AE incidence was 85.6 , 80.9 , and 86.7 % with canagliflozin 100 and 300 mg and placebo , respectively .
RESULTS	Osmotic diuresis-related AEs were more common with both canagliflozin doses , and incidences of urinary tract infections and volume depletion-related AEs were higher with canagliflozin 300 mg versus placebo .
RESULTS	Decreases in eGFR ( -2.1 , -4.0 and -1.6 ml/min/1 .73 m ( 2 ) ) were seen with canagliflozin 100 and 300 mg compared with placebo .
RESULTS	Canagliflozin 100 and 300 mg provided median percent reductions in urine albumin to creatinine ratio versus placebo ( -16.4 , -28.0 and 19.7 % ) .
CONCLUSIONS	Canagliflozin improved glycaemic control and was generally well tolerated in patients with T2DM and within a subset of Stage 3 CKD over 52 weeks .

###24740868
OBJECTIVE	To evaluate the use and effectiveness of two `` in-home '' strategies for delivering diabetes prevention programming using cable television .
METHODS	An individually randomized , two-arm intervention trial including adults with diabetes risk factors living in two US cities .
METHODS	Interventions involved a 16-session lifestyle intervention delivered via `` video-on-demand '' cable television , offered alone versus in combination with web-based lifestyle support tools .
METHODS	Repeated measures longitudinal linear regression with imputation of missing observations was used to compare changes in body weight .
RESULTS	A total of 306 individuals were randomized and offered the interventions .
RESULTS	After 5 months , 265 ( 87 % ) participants viewed at least 1 , and 110 ( 36 % ) viewed 9 of the video episodes .
RESULTS	A total of 262 ( 86 % ) participants completed a 5-month weight measurement .
RESULTS	In intention-to-treat analysis with imputation of missing observations , mean weight loss at 5 months for both treatment groups combined was 3.3 % ( 95 % CI 0.7-5 .0 % ) , regardless of intervention participation ( with no differences between randomized groups ( P = 0.19 ) ) , and was 4.9 % ( 95 % CI 2.1-6 .5 % ) for participants who viewed 9 episodes .
CONCLUSIONS	In-home delivery of evidence-based diabetes prevention programming in a reality television format , offered with or without online behavioral support tools , can achieve modest weight losses consistent with past implementation studies of face-to-face programs using similar content .

###24687744
METHODS	To study the effect of residual myrosinase ( MYR ) activity in differently processed broccoli on sulforaphane ( SR ) and iberin ( IB ) formation , bioavailability , and excretion in human volunteers .
RESULTS	Five different broccoli products were obtained with similar glucoraphanin ( GR ) and glucoiberin ( GI ) content , yet different MYR activity .
RESULTS	Excretion of SR and IB conjugates in urine were determined in 15 participants after ingestion of the broccoli products .
RESULTS	A reduction of 80 % of MYR in the product did not cause differences in the total amount of SR and IB found in urine compared to the product with 100 % MYR .
RESULTS	Complete inactivation of MYR gave the lowest total amount of SR and IB in urine ( 10 and 19 % ) .
RESULTS	A residual MYR of only 2 % in the product gave an intermediate amount ( 17 and 29 % ) .
RESULTS	The excretion half-lives of SR and IB conjugates were comparable for all the products ( 2.5 h on average ) , although the maximum excretion peak times were clearly shorter when the residual MYR was higher ( 2.3-6 .1 h ) .
CONCLUSIONS	For the first time , the effect of residual MYR activity on isothiocyanate bioavailability was systematically and quantitatively studied .
CONCLUSIONS	Processing conditions have a large effect on the kinetics and bioavailability of isothiocyanates from broccoli .

###25590292
BACKGROUND	Depression is the leading cause of early death , affecting 15 % of Americans older than 65 y and costing $ 43 billion each year .
BACKGROUND	The current mental health service system for seniors , particularly for the population hospitalized in acute inpatient psychiatric units , is fragmented because of poor funding and a shift to a transitory health care paradigm , leading to inadequate treatment modalities , questionable quality of care , and lack of research demonstrating the superiority of a particular treatment .
BACKGROUND	These issues are likely to lead to a public health crisis in the coming years .
OBJECTIVE	To investigate the effectiveness of combining exercise and psychotherapy in improving acute depressive symptoms among older adults who were receiving treatment in an inpatient psychiatric unit .
METHODS	Based on rolling admissions , inpatients were randomly assigned to 1 of 3 treatment groups .
METHODS	The study was blinded and controlled .
METHODS	This study took place in inpatient psychiatric units at the Loma Linda University 's Behavioral Medicine Center ( LLUBMC ) in Redlands , California .
METHODS	Participants were 78 inpatients , aged 50-89 y.
METHODS	Participants in the simultaneous exercise and psychotherapy ( STEP ) group ( n = 26 ) took part in exercise and received psychotherapy for 30 min per session , whereas those in the TALK group ( n = 26 ) received individual psychotherapy for 30 min per session .
METHODS	Participants in the control group ( n = 26 ) served as a comparison group , receiving standard therapy .
METHODS	The effects of the interventions were determined by assessing differences from baseline to postintervention in the symptomatology of all 3 groups .
METHODS	The research team also administered the Behavioral and Symptom Identification Scale ( BASIS-32 ) and the Geriatric Depression Scale ( GDS ) pre - and postintervention .
RESULTS	At posttest , the STEP group ( M = 4.24 , SE = 0.62 ) had a better response than the TALK group ( M = 11.34 , SE = 0.62 , P < .001 ) , which in turn showed greater improvement than the control group ( M = 14.84 , SE = 0.62 , P < .001 ) .
RESULTS	Overall , these results indicate that patients ' posttreatment depression scores were significantly lower in those receiving the STEP treatment compared with those receiving individual psychotherapy only or standard care .
CONCLUSIONS	A short-term exercise program consisting of 30 min of walking in conjunction with individual psychotherapy was an effective intervention for depression among older adults in inpatient psychiatric units .

###25150004
BACKGROUND	High levels of physical inactivity are linked to several chronic diseases including coronary heart disease , type-2 diabetes , obesity , some cancers and poor mental health .
BACKGROUND	Encouraging people to be more active has proven difficult .
BACKGROUND	One way to incorporate physical activity into the daily routine is through the journey to and from work .
BACKGROUND	Although behaviour change techniques ( BCTs ) are considered valuable in promoting behaviour change , there is very little in the published literature about the views and experiences of those encouraged to use them .
METHODS	The Walk to Work study was a feasibility study incorporating an exploratory cluster randomised controlled trial .
METHODS	The 10-week intervention involved training workplace-based Walk to Work promoters ( volunteers or nominated by participating employers ) to encourage colleagues to increase walking during their daily commute .
METHODS	The intervention used nine specific BCTs : Intention formation , barrier identification , specific goal setting , instruction , general encouragement , self-monitoring of behaviour social support , review of behavioural goals and relapse prevention .
METHODS	Digitally recorded interviews were undertaken with 22 employees , eight of whom were Walk to Work promoters to understand their views and experiences of using these techniques .
METHODS	The Framework method of data management and constant comparison were used to analyse the data and identify key themes .
RESULTS	For each individual BCT , there appeared to be people who found it useful in helping them to increase walking to work and others who did not .
RESULTS	Following training , the Walk to Work promoters varied in the extent to which they were able to fulfil their role : additional support and encouragement during the 10-week intervention may be required for the promoters to maintain motivation .
RESULTS	Wider contextual ( economic climate , unprecedented wet weather ) and organisational ( workload , car parking facilities ) issues were identified that influenced the delivery of , and response to , the intervention .
CONCLUSIONS	Walk to work interventions employing BCTs should include sufficient techniques to enable participants to choose a ` package ' to suit their needs .
CONCLUSIONS	Additional support at organisational level should also be encouraged , and consideration given to wider contextual factors that impinge on the delivery of , and response to , the intervention .
BACKGROUND	ISRCTN72882329 .

###24867313
BACKGROUND	Given the diversity of visual acuity tests being employed across the world , we compared two frequently applied tests : ETDRS charts and an eight-orientation projected Landolt C test in accordance with ISO 8596 and DIN 58220 part 3 .
BACKGROUND	The goals of the investigation were to determine ( i ) test agreement and ( ii ) test-retest reliability , to assess ( iii ) test durations , and ( iv ) the acceptance of the tests by the examinees as well as the subjects ' coping with the tests as rated by the examiner .
METHODS	Seventy-five adult subjects with a visual acuity of 0.2 ( 4/20 ) were included in one of the following groups : normal , media opacity , maculopathy , optic neuropathy , ( post ) chiasmal lesion , or amblyopia .
METHODS	Visual acuity testing was carried out monocularly , in balanced randomized order and in two runs for each test on the same eye , applying forced choice .
RESULTS	Agreement : Within each group , all tests were performed similarly , within 0.048 logMAR .
RESULTS	Reliability : Across all subject groups , with a probability of 95 % , test-retest differences were < 0.18 logMAR for both ETDRS and Landolt tests .
METHODS	The Landolt test lasted , on average , 1.8 times longer than ETDRS charts ( p < 0.001 ) .
METHODS	Acceptance : Examinees preferred the ETDRS test ( p < 0.001 ) , the examiner on average had no preference .
CONCLUSIONS	The Landolt C test and the ETDRS test yielded comparable results in visual acuity and test-retest reliability in all disease groups .
CONCLUSIONS	The ETDRS test was usually faster and more accepted by both examiners and examinees than the Landolt test .

###24570217
BACKGROUND	Depression is common after a cardiac event , yet there remain few approaches to management that are both effective and scalable .
OBJECTIVE	We aimed to evaluate the 6-month efficacy and feasibility of a tele-health program ( MoodCare ) that integrates depression management into a cardiovascular disease risk reduction program for acute coronary syndrome patients with low mood .
METHODS	A two-arm , parallel , randomized design was used comprising 121 patients admitted to one of six hospitals for acute coronary syndrome .
RESULTS	Significant treatment effects were observed for Patient Health Questionnaire 9 ( PHQ9 ) depression ( mean difference [ change ] = -1.8 ; p = 0.025 ; effect size : d = 0.36 ) for the overall sample , when compared with usual medical care .
RESULTS	Results were more pronounced effects for those with a history of depression ( mean difference [ change ] = -2.7 ; p = 0.043 ; effect size : d = 0.65 ) .
CONCLUSIONS	MoodCare was effective for improving depression in acute coronary syndrome patients , producing effect sizes exceeding those of some face-to-face psychotherapeutic interventions and pharmacotherapy .
BACKGROUND	ACTRN1260900038623 . )

###24390871
BACKGROUND	Heart failure is one of the most common und costly chronic diseases .
BACKGROUND	Patient education is an important part of heart failure therapy .
BACKGROUND	Rehabilitation aims to improve self-management abilities and the course of the disease .
BACKGROUND	A structured heart failure education program was established to create knowledge about the disease and to implement a disease friendly behavior .
BACKGROUND	The effectiveness was tested in a randomized controlled design .
METHODS	Patients were cluster randomized - assigned to an intervention group or a control group at the beginning of a rehabilitation .
METHODS	Both received a rehabilitation specifically geared to heart-failure-patients .
METHODS	The intervention group received additionally the education program , the control group a single lecture on the disease .
METHODS	At the end of rehabilitation and 6 months later the knowledge and integrity of the recommended self-tests have been checked .
METHODS	In addition the disease severity and pharmacotherapy were determined .
RESULTS	Both groups showed improvements in disease status .
RESULTS	Participants of the education program had a sustained higher knowledge , were better adjusted to medication after 6 months and documented their self-tests more frequently .
CONCLUSIONS	Regardless to the education intervention an improvement of the disease status occurs during cardiac rehabilitation .
CONCLUSIONS	The effective single components are still unclear .
CONCLUSIONS	The evaluated education program leads specifically to an improved disease-related knowledge and improved self-management skills .
CONCLUSIONS	Due to these results it seems useful to include cardiac rehabilitation in heart failure disease-management programs - a specific heart failure education program should be integrated .

###24677406
OBJECTIVE	To propose and evaluate an automatic method of extracting parenchyma from a manually delineated whole liver for the R2 * measurement of iron load .
METHODS	In all , 108 transfusion-dependent patients with a wide range of hepatic iron content were scanned with a multiecho gradient-echo sequence .
METHODS	The R2 * was measured by fitting the average signal of liver parenchyma , extracted by the proposed semiautomatic parenchyma extraction ( SAPE ) , traditional manually delineated multiple regions-of-interest ( mROIs ) , and T2 * thresholding methods to the noise-corrected monoexponential model .
METHODS	The R2 * measurement accuracy of the SAPE method was evaluated through simulation ; the intra - and interobserver reproducibility of SAPE , mROI , and T2 * thresholding were assessed from the in vivo data using coefficient of variation ( CoV ) .
RESULTS	In the simulation , the mean absolute percentage error of R2 * measurement using SAPE was 0.23 % ( range 0.01 % -1.09 % ) .
RESULTS	In vivo study , the CoVs of intra - and interobserver reproducibility were 0.83 % , 1.39 % for SAPE , 3.63 % , 6.28 % for mROI , and 1.62 % , 2.66 % for T2 * thresholding , respectively .
CONCLUSIONS	The SAPE method provides an accurate and reliable approach to assessing the overall hepatic iron content .
CONCLUSIONS	The improved magnetic resonance imaging ( MRI ) R2 * reproducibility using the SAPE method may lead to more accurate tissue characterization and increased diagnostic confidence .

###24933798
OBJECTIVE	The objective of this study was to assess the ability of a dentifrice containing 8 % arginine and calcium carbonate ( Pro-Argin ' Technology ) , and 1450 ppm fluoride as sodium monofluorophosphate ( MFP ) to prevent enamel loss from an erosive acid challenge in comparison to a silica-based dentifrice with 1450 ppm fluoride as MFP using an intra-oral erosion model .
METHODS	The intra-oral clinical study used a double blind , two-treatment , crossover design .
METHODS	A palatal retainer was used to expose the enamel specimens to the oral environment during the five-day treatment period .
METHODS	The retainer was designed to house three partially demineralized bovine enamel samples .
METHODS	The study population was composed of 24 adults , ages 18 to 70 years .
METHODS	The study consisted of two treatment periods , with a washout period lasting seven ( + / - three ) days preceding each treatment phase .
METHODS	A silica-based dentifrice without fluoride was used during the washout period .
METHODS	The Test Dentifrice used in this study contained 8 % arginine and calcium carbonate ( Pro-Argin Technology ) , and 1450 ppm fluoride as sodium monofluorophosphate ( MFP ) .
METHODS	The Control Dentifrice was silica-based and contained 1450 ppm fluoride as MFP .
METHODS	The treatment period lasted five days , during which the panelists wore the retainer 24 hours a day ( except during meals and the ex vivo acid challenges ) and brushed with their assigned product while wearing the retainer .
METHODS	The panelists brushed once in the morning and once in the evening each day for one minute , followed by a one-minute swish with the slurry and a rinse with 15 ml of water .
METHODS	The panelists brushed only their teeth and not the specimens directly .
METHODS	There were four ex vivo challenges with 1 % citric acid dispersed throughout the day : two in the morning , one in the afternoon , and one in the evening .
METHODS	Mineral loss was monitored by a quantitative light fluorescence ( QLF ) technique .
RESULTS	Twenty-three of 24 subjects successfully completed the study .
RESULTS	The one subject who did not complete the study did so for reasons unrelated to the study or products used .
RESULTS	The average percent mineral loss for the Test Dentifrice and Control Dentifrice was 9.74 + / - 13.23 and 18.36 + / - 14.14 , respectively .
RESULTS	The statistical analysis showed that the observed product differences were statistically significant ( p < 0.001 ) .
CONCLUSIONS	The Test Dentifrice with 8 % arginine , calcium carbonate , and 1450 ppm fluoride as MFP provided significantly better protection against erosive challenges in comparison to the Control Dentifrice with 1450 ppm fluoride as MFP .

###24361543
OBJECTIVE	An attentional bias for negative information plays an important role in the development and maintenance of ( social ) anxiety and depression , which are highly prevalent in adolescence .
OBJECTIVE	Attention Bias Modification ( ABM ) might be an interesting tool in the prevention of emotional disorders .
OBJECTIVE	The current study investigated whether visual search ABM might affect attentional bias and emotional functioning in adolescents .
METHODS	A visual search task was used as a training paradigm ; participants ( n = 16 adolescents , aged 13-16 ) had to repeatedly identify the only smiling face in a 4 4 matrix of negative emotional faces , while participants in the control condition ( n = 16 ) were randomly allocated to one of three placebo training versions .
METHODS	An assessment version of the task was developed to directly test whether attentional bias changed due to the training .
METHODS	Self-reported anxiety and depressive symptoms and self-esteem were measured pre - and post-training .
RESULTS	After two sessions of training , the ABM group showed a significant decrease in attentional bias for negative information and self-reported social phobia , while the control group did not .
RESULTS	There were no effects of training on depressive mood or self-esteem .
CONCLUSIONS	No correlation between attentional bias and social phobia was found , which raises questions about the validity of the attentional bias assessment task .
CONCLUSIONS	Also , the small sample size precludes strong conclusions .
CONCLUSIONS	Visual search ABM might be beneficial in changing attentional bias and social phobia in adolescents , but further research with larger sample sizes and longer follow-up is needed .

###24461572
OBJECTIVE	To evaluate the effect of early oral stimulation before the introduction of oral feeding , over the duration of concomitant tube feeding ( `` transition period '' ) , the length of hospital stay and the breastfeeding rates upon discharge in preterm infants .
METHODS	Preterm infants born between 26 and 33 weeks gestational age ( n = 86 ) , were randomized into an intervention and control group .
METHODS	Infants in the intervention group received an oral stimulation program consisting in stimulation of the oral structures for 15 min at least for 10 days , before introduction of oral feeding .
METHODS	Oral feeding was introduced at 34 weeks GA in both groups .
RESULTS	Breastfeeding rates upon discharge were significantly higher in the intervention than in the control group ( 70 % versus 45.6 % , p = 0.02 ) .
RESULTS	There was no statistical difference between the two groups in terms of the length of the transition period or the length of the hospital stay .
RESULTS	The need for prolonged CPAP support ( HR = 0.937 , p = 0.030 ) and small size for gestational age at birth ( HR = 0.338 , p = 0.016 ) were shown to be risk factors for a prolonged transition period .
CONCLUSIONS	A pre-feeding oral stimulation program improves breastfeeding rates in preterm infants .
CONCLUSIONS	The study results suggest that oral stimulation , as used in our specific population , does not shorten the transition period to full oral feeding neither the length of hospital stay .

###24603308
OBJECTIVE	We sought to examine the short - and long-term outcomes of patients who developed contrast-induced acute kidney injury ( CI-AKI ; defined as an increase in serum creatinine of 0.5 mg/dL or a 25 % relative rise within 48 h after contrast exposure ) from the large-scale HORIZONS-AMI trial .
RESULTS	Multivariable analyses were used to identify predictors of CI-AKI , as well predictors of the primary and secondary endpoints .
RESULTS	The incidence of CI-AKI in this cohort of ST-segment elevation myocardial infarction ( STEMI ) patients was 16.1 % ( 479/2968 ) .
RESULTS	Predictors of CI-AKI were contrast volume , white blood cell count , left anterior descending infarct-related artery , age , anaemia , creatinine clearance < 60 mL/min , and history of congestive heart failure .
RESULTS	Patients with CI-AKI had higher rates of net adverse clinical events [ NACE ; a combination of major bleeding or composite major adverse cardiac events ( MACE ; consisting of death , reinfarction , target vessel revascularization for ischaemia , or stroke ) ] at 30 days ( 22.0 vs. 9.3 % ; P < 0.0001 ) and 3 years ( 40.3 vs. 24.6 % ; P < 0.0001 ) .
RESULTS	They also had higher rates of mortality at 30 days ( 8.0 vs. 0.9 % ; P < 0.0001 ) and 3 years ( 16.2 vs. 4.5 % ; P < 0.0001 ) .
RESULTS	Multivariable analysis confirmed CI-AKI as an independent predictor of NACE [ hazard ratio ( [ HR ) , 1.53 ; 95 % confidence interval ( CI ) , 1.23-1 .90 ; P = 0.0001 ] , MACE ( HR , 1.56 ; 95 % CI , 1.23-1 .98 ; P = 0.0002 ) , non-coronary artery bypass grafting major bleeding ( HR , 2.07 ; 95 % CI , 1.57-2 .73 ; P < 0.0001 ) , and mortality ( HR , 1.80 ; 95 % CI , 1.19-2 .73 ; P = 0.005 ) at 3-year follow-up .
CONCLUSIONS	Contrast-induced acute kidney injury is associated with poor short - and long-term outcomes after primary percutaneous coronary intervention in STEMI .

###24574125
BACKGROUND	We investigated whether nebulization of budesonide via a NasoNeb device would treat perennial allergic rhinitis .
METHODS	We performed a parallel , randomized , double-blind , placebo-controlled , pilot study in subjects ( n = 40 ) with perennial allergic rhinitis .
METHODS	After recording baseline symptoms , subjects were randomized to budesonide respules ( 0.25 mg ) or an equivalent placebo for 26 days .
METHODS	Nasal peak inspiratory flow ( NPIF ) and nasal symptoms ( graded on a 03 scale ) were recorded by the subjects twice daily .
METHODS	Rhinoconjunctivitis quality of life ( RQOL ) as well as nasal volume , measured by acoustic rhinometry , was obtained at baseline , after 2 weeks , and at the end of treatment .
RESULTS	The average change from baseline in symptoms over the treatment period was greater for the group on budesonide ( 3.33 ) compared to placebo ( 1.98 ) ( p = 0.45 ) .
RESULTS	When the average change from baseline over the treatment period was compared between the groups , budesonide resulted in higher NPIF ( 36.4 L/min ) than placebo ( 18.7 L/min ) , p = 0.094 .
RESULTS	QOL improved in both groups compared to baseline with no significant difference between the groups .
RESULTS	Although acoustic rhinometry indicated a larger volume in the group treated with budesonide on the last trial visit , the differences between the groups were not significant when accounting for the baseline values .
CONCLUSIONS	Compared to placebo , administration of nebulized budesonide in subjects with perennial allergic rhinitis resulted in improvements in symptoms and objective measures of nasal congestion which approached but did not achieve statistical significance .
CONCLUSIONS	A higher dose of active agent , a less effective placebo and a larger number of subjects might have improved statistical significance .

###25679343
METHODS	Randomized , controlled , crossover trial .
OBJECTIVE	To examine the effects of elastic therapeutic taping ( ETT ) applied to the lumbar paraspinal region on back muscle endurance ( BME ) compared to no tape or a rigid therapeutic taping ( RTT ) procedure in individuals with nonspecific low back pain .
BACKGROUND	Elastic therapeutic taping is an increasingly popular intervention for clinicians who treat patients with low back pain .
BACKGROUND	However , no studies have investigated the effect of ETT on back extensor muscle performance in a symptomatic population .
METHODS	We measured BME in 16 patients ( mean SD age , 44.8 10.4 years ; 44 % female ) with nonspecific low back pain .
METHODS	Back muscle endurance was measured using the Biering-Srensen test under 3 different conditions : ETT , no tape , and RTT .
METHODS	For the ETT condition , the tape was applied over the paraspinal muscles according to the Kinesio Tex taping protocol .
METHODS	The RTT condition consisted of the same tape configuration but using nonelastic athletic tape .
METHODS	All participants received each testing condition in random order , with 1 to 3 days between each condition .
METHODS	Differences in BME between the 3 testing conditions were explored with repeated-measures analyses of variance .
RESULTS	There were no differences in BME between ETT and RTT , or between the RTT and no-tape conditions .
RESULTS	The difference in BME between the ETT and no-tape conditions was statistically significant ( mean difference , 20.7 seconds ; 95 % confidence interval : 6.8 , 34.5 ; P = .006 ) but within the threshold of measurement error .
CONCLUSIONS	Back muscle endurance was higher with ETT applied over the paraspinal musculature when compared to a no-tape condition .
CONCLUSIONS	However , the magnitude of difference did not exceed measurement error .
CONCLUSIONS	There was no difference in BME when using elastic or rigid therapeutic tape .

###24519100
BACKGROUND	Studies have shown a mismatch between published cancer screening and genetic counseling referral recommendations and physician-reported screening and referral practices .
BACKGROUND	Inaccurate cancer risk assessment is one potential cause of this mismatch .
OBJECTIVE	To assess U.S. physicians ' ability to accurately determine a woman 's colon and ovarian cancer risk level .
METHODS	Cross-sectional survey of U.S. family physicians , general internists , and obstetrician-gynecologists .
METHODS	A twelve-page questionnaire with a vignette of a woman 's annual examination included a question about the patient 's level of colon and ovarian cancer risk .
METHODS	The final study sample included 1,555 physicians weighted to represent practicing U.S. physicians nationally .
METHODS	Accuracy of physicians ' ovarian and colon cancer risk assessments .
RESULTS	Overall , most physicians accurately assessed women 's risk of ovarian ( 57.0 % , CI 54.3 , 59.6 ) and colon cancer ( 62.0 % , CI 59.4 , 64.6 ) .
RESULTS	However , 27.1 % ( CI 23.0 , 31.6 ) of physicians overestimated the ovarian cancer risk among women at the same risk as the general population , and 65.1 % ( CI 60.2 , 69.7 ) underestimated ovarian cancer risk among women at much higher risk than the general population .
RESULTS	Physicians overestimated colon more than ovarian cancer risk ( 38.0 % , CI 35.4 , 40.6 vs. 27.1 % , CI 23.0 , 31.6 ) for women at the same risk as the general population .
CONCLUSIONS	Physicians ' misestimation of patient ovarian and colon cancer risk may put average risk patients in jeopardy of unnecessary screening and higher risk patients in jeopardy of missed opportunities for prevention or early detection of cancers .

###25137523
BACKGROUND	The endoscopically magnified operative field in functional endoscopic sinus surgery ( FESS ) makes even a small amount of bleeding a potentially significant hindrance .
BACKGROUND	It is thought that irrigation with hot saline during surgery may improve surgical field of view by producing a hemostatic effect .
BACKGROUND	Our objective was to assess the effectiveness of hot saline irrigation ( HSI ) compared to room temperature saline irrigation ( RTSI ) in the control of intraoperative bleeding during FESS .
METHODS	Sixty-two chronic rhinosinusitis ( CRS ) patients undergoing FESS were randomized to 2 treatment arms in an equal ratio .
METHODS	Subjects received either HSI ( 49C ) or RTSI ( 18C ) , 20 mL every 10 minutes , for the duration of FESS .
METHODS	The Boezaart endoscopic field of view grading system was the primary outcome measure .
METHODS	Boezaart score , heart rate , and mean arterial blood pressure ( MABP ) were recorded at 10-minute intervals between irrigations .
RESULTS	Mean endoscopic surgical field of view ( Boezaart score ) did not significantly differ between the HSI and RTSI groups ( 1.5 0.6 vs 1.3 0.5 ; p = 0.23 ) .
RESULTS	However , when FESS was longer than 2 hours in duration , the Boezaart scores were significantly better in the HSI group ( 1.6 0.6 vs 1.2 0.4 ; p = 0.04 ) .
RESULTS	We found that blood loss per minute was significantly reduced ( p = 0.02 ) in all cases in which HSI was used ( 2.3 1.0 ) compared to RTSI ( 1.7 1.1 ) .
RESULTS	Despite this , heart rate ( p = 0.32 ) and MABP ( p = 0.14 ) did not significantly differ between treatment groups .
CONCLUSIONS	HSI may be beneficial in improving surgical field of view in FESS after 2 hours of operating time .
CONCLUSIONS	A significant reduction in rate of blood loss may be attained with HSI .

###24985938
OBJECTIVE	Cerebral ischemia is a known complication of carotid cross-clamping during carotid endarterectomy .
OBJECTIVE	Selective intraluminal shunting for cerebral protection is not always effective and carries risks .
OBJECTIVE	The purpose of this study was to identify potentially modifiable risk factors for intraoperative cerebral ischemia and shunting during carotid endarterectomy .
METHODS	We performed an historical case-control chart review of primary carotid endarterectomies with electroencephalographic ( EEG ) monitoring and selective shunting .
METHODS	Randomized controls and cases that showed ischemic EEG changes and required shunting were matched by year of surgery and the presence or absence of a contralateral carotid occlusion .
METHODS	Detailed perioperative data were collected for all cases .
METHODS	Results were analyzed using the Mantel-Haenszel test , analysis of variance , and a multivariate logistic regression model .
RESULTS	Of 523 charts screened , 69 patients had experienced evidence of cerebral ischemia on clamping of the carotid and required shunting .
RESULTS	These patients were more likely than their matched controls to have been receiving regular preoperative beta blockers ( 33/69 vs 18/69 , respectively ; P = 0.01 ; odds ratio [ OR ] 2.5 ; 95 % confidence interval [ CI ] 1.2 to 5.1 ) .
RESULTS	Ipsilateral moderate carotid stenosis ( 60-80 % ) was also associated with increased risk .
RESULTS	An adjusted multivariate regression model estimated an OR of 3.6 ( 95 % CI 1.5 to 8.9 ; P = 0.005 ) for the association between use of a beta blocker and shunting .
RESULTS	Intraoperative hemodynamic values were similar for the shunt and control groups as well as for patients receiving and not receiving preoperative beta blockers .
CONCLUSIONS	The current study found an association between regular preoperative use of beta blockers and intraoperative cerebral ischemia in patients undergoing carotid endarterectomy .
CONCLUSIONS	This effect did not relate to intraoperative hemodynamics .

###25417401
OBJECTIVE	To observe the influence of Xinfengcapsule ( XFC ) on abarticular pathologic changes ( APCs ) and other indices of patients with rheumatoid arthritis ( RA ) and explore the mechanism of action of XFC in improving such changes .
METHODS	Three-hundred RA patients were divided randomly into a treatment group ( n = 150 ) and control group ( n = 150 ) .
METHODS	A normal control ( NC ) group ( n = 90 ) was also created .
METHODS	Changes in cardiac function , pulmonary function , anemia indices and platelet parameters of RA patients were measured .
METHODS	Curative effects of the two groups were compared , and comparison carried out with the NC group .
RESULTS	In 300 RA patients , late diastolic peak flow velocity ( A peak ) was much higher ( P < 0.01 ) and early diastolic peak flow velocity ( E peak ) , E/A , and left ventricular fraction shortening much lower ( P < 0.01 ) than those in the NC group .
RESULTS	Vital capacity ( VC ) , forced vital capacity in one second , forced vitalcapacity ( FVC ) , maximal voluntary ventilation ( MVV ) , maximal expiratory flow in 50 % of VC ( FEF50 ) and FEF75 were lowered remarkably ( P < 0.05 or P < 0.01 ) .
RESULTS	Platelet count ( PLT ) , plateletcrit ( PCT ) and mean platelet volume ( MPV ) increased markedly ( P < 0.05 or P < 0.01 ) , and hemoglobin ( Hb ) level decreased significantly ( P < 0.05 ) .
RESULTS	After XFC treatment , the A peak and PLT and PCT were much lower ( P < 0.05 ) , and E/A and the number of red blood cells as well as Hb level were much higher ( P < 0.05 ) , as were FVC , MVV and FEF50 ( P < 0.05 or P < 0.01 ) , in the treatment group than those in the NC group .
RESULTS	Total score of pain and swelling in joints , uric-acid level and high-sensitivity C-reactive protein level were much lower , and superoxide dismutase level as well as the number of CD4 + CD25 + regulation T cells ( Treg ) and CD4 + CD25 + CD127 - Treg were much higher ( P < 0.05 or P < 0.01 ) in the treatment group than those in the NC group .
CONCLUSIONS	RA patients with pathologic changes in joints also suffer from lower cardiac and pulmonary functions and from parameters of anemia and platelet factors .
CONCLUSIONS	XFC can improve the symptoms of RA patients , ameliorate their cardiac and pulmonary functions and reduce the parameters of anemia and platelet factors .
CONCLUSIONS	XFC lowers the immune inflammatory reaction to improve APCs in RA patients .

###24678758
OBJECTIVE	Although physiotherapy has demonstrated effectiveness in preventing ankle arthropathy compared to prophylaxis treatment from early ages , there have been no conclusive studies examining physiotherapy intervention once hemophilic arthropathy of the ankle has been established .
OBJECTIVE	The aim of this study was to evaluate the effectiveness of two physiotherapy interventions , in patients with hemophilic arthropathy of the ankle that had not been operated on previously .
METHODS	Nine patients with hemophilia ( mean age of 35.7 SD 11.9 years ) were randomized to a mobilization group ( n = 5 ) and manual therapy group ( n = 4 ) .
METHODS	The two physiotherapy interventions were : ( 1 ) passive mobilization and stretching ; and ( 2 ) manual orthopaedic therapy , both with proprioception training .
METHODS	The study lasted for six weeks , with two sessions a week .
METHODS	Ankle mobility and pain perception , lower limb proprioception and quality of life were the outcome measures .
RESULTS	Both treatments improved all ankle movements ( p < 0.05 ) .
RESULTS	The treatment with passive mobilizations also improved the perception of pain and quality of life .
RESULTS	Six months later , both groups still had improved articular movement with the exception of plantar flexion and continued to perceive less pain .
CONCLUSIONS	Both physiotherapy interventions improved the range of movement and lessened pain in patients with ankle arthropathy .
CONCLUSIONS	No haemarthrosis was recorded during treatment or during the follow-up period .

###24904204
OBJECTIVE	To investigate the therapeutic effect of transcutaneous electrical nerve stimulation ( TENS ) on poststroke urinary incontinence ( UI ) .
METHODS	Sixty-one patients with poststroke UI were enrolled at the Neurology Department in the Shanghai Tenth People 's Hospital of Tongji University between January 2010-January 2011 and were divided into treatment and control groups ( n = 32 and n = 29 , respectively ) .
METHODS	TENS was applied to the treatment group , while the control group received basic therapy .
METHODS	The therapeutic group completed the whole set of TENS therapy with a treatment frequency of 30 minutes once a day for 60 days .
METHODS	The positive electrode was placed on the second lumbar spinous process , and the negative electrodes were inside the middle and lower third of the junction between the posterior superior iliac spine and ischia node .
METHODS	The overactive bladder symptom score , Barthel Index , and urodynamics examination were estimated before and after therapy in both groups .
RESULTS	The daily micturition , nocturia , urgent urination , and urge UI in the treatment group significantly improved compared to the control group ( P < 0.05 ) .
RESULTS	The patients in the treatment group were superior in the self-care ability of daily living and also had an advantage over the indexes on maximum cystometry volume , flow rate , and the pressure of detrusor in the end of the filling phase .
CONCLUSIONS	TENS improved incontinence symptoms , enhanced the quality of life , and decreased adverse effects ; hence , it is recommended in treating poststroke UI .

###24574869
OBJECTIVE	To reveal the additional value of radiographic bitewings ( BW ) in detection of caries and in comparing the occurrence of clinically undetected severe decay between 14-year olds with and without clinically observed dentinal caries in a low-caries prevalence population .
METHODS	The cross-sectional study used 363 pairs of radiographs read by one examiner without knowledge of the clinical findings .
METHODS	The yield was analyzed on a tooth surface level by cross tabulating the clinical and radiographic information and on an individual level by counting the number of yield surfaces for all subjects .
METHODS	Mann-Whitney U test was used .
RESULTS	On a tooth surface level , the contribution of BW was the greatest on the occlusal surfaces of the first molars , where established or severe dentinal decay was registered in BW in 11 % of clinically sound surfaces and in 40 % of established cavitated enamel lesions .
RESULTS	On an individual level , 53 % of subjects benefited from BW .
RESULTS	The subjects clinically DMFS > 0 benefited more than the clinically DMFS = 0 subjects ( P = .004 ) , nearly 60 % in relation to 47 % , respectively .
CONCLUSIONS	In a low-caries prevalence population a remarkable portion of both clinically DMFS = 0 and DMFS > 0 14-year olds benefit from BW examination .
CONCLUSIONS	Most of the benefit is obtained on the occlusal surfaces of the first and the second permanent molars .

###24704684
BACKGROUND	The efficacy and safety of clindamycin phosphate 1.2 % / tretinoin 0.025 % ( Clin-RA ) were evaluated in three 12-week randomised studies .
OBJECTIVE	To perform a pooled analysis of data from these studies to evaluate Clin-RA 's efficacy and safety in a larger overall population , in subgroups of adolescents and according to acne severity .
METHODS	4550 patients were randomised to Clin-RA , clindamycin , tretinoin and vehicle .
METHODS	Evaluations included percentage change in lesions , treatment success rate , proportions of patients with 50 % or 80 % continuous reduction in lesions , adverse events and cutaneous tolerability .
RESULTS	In the overall population , the percentage reduction in inflammatory , non-inflammatory and total lesions and the treatment success rate were significantly greater with Clin-RA compared with clindamycin , tretinoin and vehicle alone ( all p < 0.01 ) .
RESULTS	The percentage reduction in all types of lesions was also significantly greater with Clin-RA in the adolescent subgroup ( 2915 patients , p < 0.002 ) and in patients with mild/moderate acne ( 3662 patients , p < 0.02 ) versus comparators .
RESULTS	In patients with severe acne ( n = 880 ) , the percentage reduction in all lesion types was significantly greater with Clin-RA versus vehicle ( p < 0.0001 ) .
RESULTS	A greater proportion of Clin-RA treated patients had a 50 % or 80 % continuous reduction in all types of lesions at week 12 compared with clindamycin , tretinoin and vehicle .
RESULTS	Adverse event frequencies in the active and vehicle groups were similar .
RESULTS	Baseline-adjusted mean tolerability scores over time were < 1 ( mild ) and similar in all groups .
CONCLUSIONS	Clin-RA is safe , has superior efficacy to its component monotherapies and should be considered as one of the first-line therapies for mild-to-moderate facial acne .

###25420010
METHODS	Participant - and assessor-blinded randomized clinical trial .
OBJECTIVE	To compare a rehabilitation program thought to increase the size of the intervertebral foramen ( IVF ) of the affected nerve root to a rehabilitation program that does n't include any specific techniques thought to increase the size of the IVF in patients presenting with cervical radiculopathy ( CR ) .
BACKGROUND	Clinical approaches for the treatment of CR commonly include exercises and manual therapy techniques thought to increase the size of the IVF , but evidence regarding the effectiveness of these specific manual therapy techniques is scarce .
METHODS	Thirty-six participants with CR were randomly assigned either to a group that received a manual therapy and exercise program aimed at increasing the size of the IVF of the affected nerve root ( experimental group , n = 18 ) or to a group that received a manual therapy and exercise program without the specific goal of increasing the size of the IVF of the affected level and side ( comparison group , n = 18 ) .
METHODS	Primary ( Neck Disability Index ) and secondary ( shortened version of the Disabilities of the Arm , Shoulder and Hand questionnaire [ QuickDASH ] and numeric pain-rating scale ) outcomes were evaluated at baseline , at the end of the 4-week program ( week 4 ) , and 4 weeks later ( week 8 ) .
METHODS	A mixed-model , 2-way analysis of variance was used to analyze treatment effects .
RESULTS	No significant group-by-time interaction or group effect was observed for Neck Disability Index , QuickDASH , and numeric pain-rating scale scores ( P. 14 ) following the intervention .
RESULTS	However , both groups showed statistically and clinically significant improvement from baseline to week 4 and to week 8 in Neck Disability Index , QuickDASH , and numeric pain-rating scale scores ( P < .05 ) .
CONCLUSIONS	Results suggest that manual therapy and exercises are effective in reducing pain and functional limitations related to CR .
CONCLUSIONS	The addition of techniques thought to increase the size of the IVF of the affected nerve root yielded no significant additional benefits .
CONCLUSIONS	Given the absence of a `` no treatment '' group , a spontaneous resolution of symptoms can not be excluded .
CONCLUSIONS	However , the magnitude of improvement makes spontaneous resolution unlikely .
CONCLUSIONS	The trial was registered at ClinicalTrials.gov ( NCT01500044 ) .
METHODS	Therapy , level 1b - .

###24338186
OBJECTIVE	To study the changes of adenosine diphosphate ( ADP ) - induced platelet aggregation rate , and evaluate the effects of Maixuekang Capsule ( , MKC ) on platelet aggregation rate and long-term prognosis of patients with acute coronary syndrome after percutaneous coronary intervention ( PCI ) .
METHODS	A total of 236 patients with acute coronary syndrome , who received successful PCI , were randomly assigned to a trial group ( 116 cases ) and a control group ( 120 cases ) according to random numbers ; treatment allocation occurred when the participants met the inclusion criteria and signed the informed consent forms .
METHODS	In the trial group , the patients were treated with MKC combined with routine medication , and in the control group the patients were treated with routine medication .
METHODS	The therapeutic course for the two groups was 12 months and the follow-up was 12 months .
METHODS	The levels of ADP-induced platelet aggregation rate and serum high-sensitive C-reactive protein ( hs-CRP ) were determined before PCI , 12 h and 30 days after PCI .
METHODS	In the meantime , the incidence of cardio - / cerebrovascular events was recorded during the 12-month follow-up .
RESULTS	Compared with before PCI , the levels of ADP-induced platelet aggregation rate and serum hs-CRP were significantly higher at 12 h after PCI ( P < 0.05 ) .
RESULTS	They were significantly reduced after 30-day-treatment of MKC , showing statistical differences when compared with those in the control group ( P < 0.05 ) .
RESULTS	During the 12-month follow-up , the incidence of cardio - / cerebrovascular events was significantly lower in the trial group than in the control group ( 6.9 % vs. 12.5 % , P < 0.01 ) .
CONCLUSIONS	ADP-induced platelet aggregation function was significantly elevated after PCI .
CONCLUSIONS	MKC improved the prognosis of patients with acute coronary syndrome , possibly through inhibiting the platelet aggregation , fighting against inflammation , and protecting the vascular endothelial function .

###25112695
OBJECTIVE	To test the hypothesis that telemedicine can reliably be used for many aspects of circulatory and neurologic examinations of children admitted to a pediatric intensive care unit ( PICU ) .
METHODS	A prospective , randomized study in a 14-bed PICU in a tertiary care , academic-affiliated institution .
METHODS	Eligible patients were > 2 months or < 19 years of age , not involved in a concurrent study , had parents/guardian able to sign an informed consent form , were not at end-of-life , and had an attending who not only deemed them medically stable , but also felt that the study would not interrupt their care .
METHODS	Other than the Principal Investigator , 6 pediatric intensivists and 7 pediatric critical care fellows were eligible study providers .
METHODS	Two physician providers were randomly assigned to perform circulatory and neurologic examinations according to the American Heart Association/Pediatric Advanced Life Support guidelines in-person and via telemedicine .
METHODS	Findings were recorded on a standardized data collection form and compared .
RESULTS	One hundred ten data collection forms were completed .
RESULTS	For many aspects of the circulatory and neurologic examinations , outcomes showed substantial to perfect agreement between the in-person and telemedical care providers ( kappa = 0.64-1 .00 ) .
RESULTS	However , assessments of muscle tone had a kappa = 0.23 , with a kappa = 0.37 for skin color .
CONCLUSIONS	Telemedicine can reliably identify normal and abnormal findings of many aspects of circulatory and neurologic examinations in PICU patients .
CONCLUSIONS	This finding opens the door to further studies on the use of telemedicine across other disciplines .

###25187584
BACKGROUND	Vitamin C has been proposed to improve outcomes after a distal radial fracture by promotion of bone and soft-tissue healing and reduction of the prevalence of complex regional pain syndrome ( CRPS ) .
BACKGROUND	Our primary aim was to examine the effect of vitamin C on functional outcome after a distal radial fracture .
METHODS	A total of 336 adult patients with an acute fracture of the distal aspect of the radius were recruited over a one-year period and randomized to receive 500 mg of vitamin C or placebo daily for fifty days after the fracture .
METHODS	The primary outcomes were the DASH ( Disabilities of the Arm , Shoulder and Hand ) score at six weeks and at one year .
METHODS	Secondary variables included complications , wrist and finger motion , grip and pinch strength , pain , and a CRPS score .
RESULTS	There were no significant differences in patient or fracture characteristics between the treatment groups .
RESULTS	There was no significant effect of vitamin C on the DASH score throughout the study period .
RESULTS	At six weeks , patients in the vitamin C group with a nondisplaced fracture had a significantly greater wrist flexion deficit ( p = 0.008 ) and pinch strength deficit ( p = 0.020 ) and a greater rate of CRPS ( p = 0.022 ) , but there was no difference in the CRPS rate at any other time point .
RESULTS	At twenty-six weeks , there was a higher rate of complications ( p = 0.043 ) and greater pain with use ( p = 0.045 ) in the patients with a displaced fracture treated with vitamin C.
RESULTS	There was no significant difference in the time to fracture-healing .
CONCLUSIONS	This study demonstrated no significant difference at one year in the DASH score , other functional outcomes , the rate of CRPS , or osseous healing of nondisplaced or displaced distal radial fractures treated with vitamin C compared with placebo .
CONCLUSIONS	We conclude that administration of vitamin C confers no benefit to patients with a displaced or nondisplaced fracture of the distal aspect of the radius .
METHODS	Therapeutic Level II .
METHODS	See Instructions for Authors for a complete description of levels of evidence .

###25131925
OBJECTIVE	Heart failure ( HF ) is a common but serious condition which involves a significant economic burden on the health care economy .
OBJECTIVE	The purpose of this study was to evaluate cost and quality of life ( QoL ) implications of implementing a HF management program ( HFMP ) in primary health care ( PHC ) .
RESULTS	This was a prospective randomized open-label study including 160 patients with a diagnosis of HF from five PHC centers in south-eastern Sweden .
RESULTS	Patients randomized to the intervention group received information about HF from HF nurses and from a validated computer-based awareness program .
RESULTS	HF nurses and physicians followed the patients intensely in order to optimize HF treatment according to current guidelines .
RESULTS	The patients in the control group were followed by their regular general practitioner ( GP ) and received standard treatment according to local management routines .
RESULTS	No significant changes were observed in NYHA class and quality-adjusted life years ( QALY ) , implying that functional class and QoL were preserved .
RESULTS	However , costs for hospital care ( HC ) and PHC were reduced by EUR 2167 , or 33 % .
RESULTS	The total cost was EUR 4471 in the intervention group and EUR 6638 in the control group .
CONCLUSIONS	Introducing HFMP in Swedish PHC in patients with HF entails a significant reduction in resource utilization and costs , and maintains QoL .
CONCLUSIONS	Based on these results , a broader implementation of HFMP in PHC may be recommended .
CONCLUSIONS	However , results should be confirmed with extended follow-up to verify long-term effects .

###25695061
BACKGROUND	Postoperative nausea and vomiting ( PONV ) is one of common complications in patients undergoing laparoscopic cholecystectomy ( LC ) .
BACKGROUND	Aim of this study was to compare the efficacy of subhypnotic ( 1 mg/kg/h ) infusion of propofol with dexamethasone on PONV in patients undergoing LC .
METHODS	A total of 120 patients were included in this randomized , double-blind , placebo-controlled study .
METHODS	Patients were randomly assigned to 3 groups ; patients of group dexamethasone ( group D ) were administrated 8 mg dexamethasone before induction of anesthesia , patients of group propofol ( group P ) were infused to subhypnotic ( 1 mg/kg/h ) propofol during operation and patients of group control ( group C ) were applied infusion of 10 % intralipid .
METHODS	The incidence of PONV and needs for rescue analgesic and antiemetic were recorded in the first 24 h postoperatively .
RESULTS	In the 0-24 h , the incidence of PONV was significantly lower in the group D and group P compared with the group C ( 37.5 % , 40 % , and 72.5 % , resp . )
RESULTS	There was no significant difference in the incidence of PONV and use of antiemetics and analgesic between group D and group P.
CONCLUSIONS	We concluded that infusion of propofol 1 mg/kg/h is as effective as dexamethasone for the prevention of PONV during the first 24 hours after anesthesia in patients undergoing LC .

###26027630
BACKGROUND	The ODYSSEY COMBO I study ( http://clinicaltrials.gov/show/NCT01644175 ) evaluated efficacy and safety of alirocumab as add-on therapy to stable maximally tolerated daily statin with or without other lipid-lowering therapy in high cardiovascular risk patients with suboptimally controlled hypercholesterolemia .
METHODS	This multicenter , phase 3 , randomized ( 2:1 alirocumab vs placebo ) , double-blind , 52-week trial enrolled 316 patients with established coronary heart disease or coronary heart disease risk equivalents and hypercholesterolemia .
METHODS	Alirocumab ( 75 mg every 2 weeks [ Q2W ] ) or placebo Q2W was self-administered subcutaneously via 1 mL prefilled pen .
METHODS	The alirocumab dose was increased to 150 mg Q2W ( also 1 mL ) at week 12 if week 8 low-density lipoprotein cholesterol ( LDL-C ) was 70 mg/dL .
METHODS	The primary efficacy end point was percent change in LDL-C from baseline to week 24 ( intention-to-treat analysis ) .
RESULTS	At week 24 , estimated mean ( 95 % CI ) changes in LDL-C from baseline were -48.2 % ( -52.0 % to -44.4 % ) and -2.3 % ( -7.6 % to 3.1 % ) for alirocumab and placebo , respectively , an estimated mean ( 95 % CI ) difference of -45.9 % ( -52.5 % to -39.3 % ) ( P < .0001 ) .
RESULTS	Low-density lipoprotein cholesterol < 70 mg/dL was achieved by 75 % alirocumab versus 9 % placebo patients at week 24 .
RESULTS	At week 12 , 83.2 % of evaluable alirocumab-treated patients remained on 75-mg Q2W .
RESULTS	Treatment-emergent adverse events were comparable between groups .
CONCLUSIONS	Alirocumab treatment achieved a significantly greater reduction in LDL-C and allowed a greater proportion of patients to achieve LDL-C goals , versus placebo after 24 weeks in high cardiovascular risk patients with suboptimally controlled hypercholesterolemia at baseline despite receiving maximally tolerated statin with or without other lipid-lowering therapy .
CONCLUSIONS	The frequency of treatment-emergent adverse events and study medication discontinuations were generally comparable between treatment groups .

###24254885
BACKGROUND	The Trial to Assess Chelation Therapy ( TACT ) showed clinical benefit of an EDTA-based infusion regimen in patients aged 50 years with prior myocardial infarction .
BACKGROUND	Diabetes mellitus before enrollment was a prespecified subgroup .
RESULTS	Patients received 40 infusions of EDTA chelation or placebo .
RESULTS	A total of 633 ( 37 % ) patients had diabetes mellitus ( 322 EDTA and 311 placebo ) .
RESULTS	EDTA reduced the primary end point ( death , reinfarction , stroke , coronary revascularization , or hospitalization for angina ; 25 % versus 38 % ; hazard ratio , 0.59 ; 95 % confidence interval [ CI ] , 0.44-0 .79 ; P < 0.001 ) over 5 years .
RESULTS	The result remained significant after Bonferroni adjustment for multiple subgroups ( 99.4 % CI , 0.39-0 .88 ; adjusted P = 0.002 ) .
RESULTS	All-cause mortality was reduced by EDTA chelation ( 10 % versus 16 % ; hazard ratio , 0.57 ; 95 % CI , 0.36-0 .88 ; P = 0.011 ) , as was the secondary end point ( cardiovascular death , reinfarction , or stroke ; 11 % versus 17 % ; hazard ratio , 0.60 ; 95 % CI , 0.39-0 .91 ; P = 0.017 ) .
RESULTS	However , after adjusting for multiple subgroups , those results were no longer significant .
RESULTS	The number needed to treat to reduce 1 primary end point over 5 years was 6.5 ( 95 % CI , 4.4-12 .7 ) .
RESULTS	There was no reduction in events in non-diabetes mellitus ( n = 1075 ; P = 0.877 ) , resulting in a treatment by diabetes mellitus interaction ( P = 0.004 ) .
CONCLUSIONS	Post-myocardial infarction patients with diabetes mellitus aged 50 demonstrated a marked reduction in cardiovascular events with EDTA chelation .
CONCLUSIONS	These findings support efforts to replicate these findings and define the mechanisms of benefit .
CONCLUSIONS	However , they do not constitute sufficient evidence to indicate the routine use of chelation therapy for all post-myocardial infarction patients with diabetes mellitus .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00044213 .

###25509731
OBJECTIVE	To compare the efficacy differences between dog-days medicinal vesiculation and regular-day medicinal vesiculation for perennial allergic rhinitis ( PAR ) , and observe their effects on serum immune globulin E ( IgE ) and interleukin-4 ( IL-4 ) .
METHODS	Seventy-two patients were randomly divided into a dog-days moxibustion group ( 34 cases ) and a regular-day moxibustion group ( 38 cases ) .
METHODS	In the dog-days moxibustion group , medicinal vesiculation was applied on the 1st dog-day , 2nd dog-day and last dog-day in summer by lunar calendar , 3 treatments per dog-day for totally 9 times .
METHODS	In the regular-day moxibustion group , the moxibustion was given on the regular day for continuous 9 times .
METHODS	The symptom score , rhinoconjunctivitis quality of life questionnaire ( RQLQ ) and the level of IgE and IL-4 were compared before and after treatment in two groups ; the short-term and two-year efficacy evaluation were performed too .
RESULTS	The short-term total effective rate was 88.2 % ( 30/34 ) in the dog-days moxibustion group , which was not significantly different to 86.8 % ( 33/38 ) in the regular-day moxibustion group ( P > 0.05 ) .
RESULTS	The long-term total effective rate was 97.1 % ( 33/34 ) in the dog-days moxibustion group , which was significantly superior to 81.6 % ( 31/38 ) in the regular-day moxibustion group ( P < 0.05 ) .
RESULTS	After treatment , the serum IgE , IL-4 and RQLQ were significantly reduced ( all P < 0.01 ) , but the difference between two groups was not significant ( all P > 0.05 ) .
CONCLUSIONS	Medicinal moxibustion could be taken as a regular treatment for PAR , which could be performed during the whole year , and dog-days moxibustion could be considered as an enhanced method for prevention and treatment of PAR .

###24281283
OBJECTIVE	The prefrontal cortex may be a promising target for the use of transcranial direct current stimulation ( tDCS ) in the management of pain symptoms .
OBJECTIVE	The present study explored the effects of anodal and cathodal tDCS over the left dorsolateral prefrontal cortex on the effects of perceived pain controllability .
METHODS	Forty-one participants received continuous anodal or cathodal tDCS and underwent a laboratory pain task designed to manipulate the perception of pain control .
METHODS	Participants were told that they would be completing a reaction-time task ( press keyboard button of corresponding arrow shown on computer screen with either green or red background ) .
METHODS	A thermal pain stimulus was delivered following each trial by a thermode placed on the participant 's left forearm .
METHODS	Although pain stimuli were pseudorandomally ordered and matched for total duration between control ( green ) and noncontrol ( red ) trials , participants were told that if they responded correctly and more quickly on green trials than their average reaction times , the thermal pain stimulus duration would be decreased ( ie , perceived control ) .
METHODS	Participants were told they had no control of pain stimulus duration over trials presented with the red background .
RESULTS	There was a significant main effect for tDCS condition ( anode vs. cathode ) on pain unpleasantness ratings ( P < 0.04 ) .
RESULTS	Specifically , individuals receiving cathodal tDCS reported higher pain unpleasantness ratings ( least squares mean = 69.40 , SE = 3.72 ) , whereas those receiving anodal tDCS reported lower pain unpleasantness ratings ( least squares mean = 58.05 , SE = 3.81 ) .
RESULTS	Exploratory analysis revealed a simple main effect for tDCS group at the level of perceived controllability ( P < 0.02 ) .
RESULTS	In addition , participants receiving cathodal tDCS subjectively reported feeling less control of the painful stimuli than those receiving anodal tDCS .
CONCLUSIONS	Left dorsolateral prefrontal cortex tDCS may play a role in modulating the neurocircuitry involved with the perception of control over pain .

###24266596
BACKGROUND	Hereditary angioedema ( HAE ) is a rare disease caused by C1-esterase inhibitor ( C1-INH ) deficiency , characterized by periodic attacks of acute edema affecting subcutaneous ( SC ) tissues and mucous membranes .
BACKGROUND	Human C1-INH concentrate given intravenously ( IV ) is effective and safe , but venous access may be difficult .
BACKGROUND	We compared SC and IV administration of human pasteurized C1-INH concentrate with respect to pharmacokinetics , pharmacodynamics , and safety .
METHODS	This was a prospective , randomized , open-label , crossover study .
METHODS	Twenty-four subjects with mild or moderate HAE were randomly assigned during an attack-free interval to receive 1000 units of human pasteurized C1-INH concentrate IV or SC .
METHODS	Plasma levels of C1-INH activity and antigen , C4 antigen , cleaved high-molecular-weight kininogen ( clHK ) , and C1-INH antibodies were measured .
RESULTS	The mean relative bioavailability of functional C1-INH after SC administration was 39.7 % .
RESULTS	Maximum C1-INH activity after SC administration occurred within 48 hours and persisted longer than after IV administration .
RESULTS	C4 antigen levels increased and clHK levels decreased after IV and SC administration , indicating the pharmacodynamic action of C1-INH .
RESULTS	The mean half-life of functional C1-INH was 62 hours after IV administration and 120 hours after SC administration ( p = 0.0595 ) .
RESULTS	C1-INH concentrate was safe and well tolerated when administered via both routes .
RESULTS	As expected , SC administration resulted in a higher incidence of injection site reactions , all of which were mild .
CONCLUSIONS	With a relative bioavailability of 39.7 % , SC administration of human pasteurized C1-INH yields potentially clinically relevant and sustained plasma levels of C1-INH and is safe and well tolerated .

###24347766
OBJECTIVE	Safe parenteral drug administration includes preparation of safe medication for administration .
OBJECTIVE	Training medical students is crucial to minimize medication administration errors .
OBJECTIVE	The study aims to develop a module to teach drug preparation skills and to develop objective structured practical examination ( OSPE ) stations to assess these skills .
OBJECTIVE	Students ' perceptions regarding the module were also assessed .
METHODS	A module was developed to teach following skills to 2 ( nd ) year medical students : Aspiration of a drug from the ampule , aspiration of the drug from the vial , aspiration of the drug in powdered form from vial ( reconstitution ) , and setting up an intravenous ( IV ) infusion .
METHODS	A randomized case control study design was used to establish the validity of OSPE stations .
METHODS	Student volunteers were grouped into case ( n = 20 ) and control groups ( n = 20 ) by simple randomization .
METHODS	The test group watched videos of skills and received demonstration of skills and a practice session before OSPE , whereas the control group watched videos before the OSPE and received demonstration and a practice session only after the OSPE .
METHODS	Each student was assessed by two faculty members during OSPE using a validated checklist .
METHODS	Mean OSPE scores of control and test groups were compared using independent samples t-test .
METHODS	Interrater reliability and concurrent validity of stations were analyzed using interclass correlation coefficient ( ICC ) and Pearson correlation , respectively .
METHODS	Students ' responses were expressed as median and interquartile range .
RESULTS	The response rate in the questionnaire was 100 % .
RESULTS	Significant difference between mean scores ( P < 0.05 ) of test and control groups revealed fulfillment of construct validity of OSPE stations .
RESULTS	Interrater reliability ( ICC > 0.7 ) and concurrent validity ( r value > 7 ) of all the stations was high .
RESULTS	Perceptions revealed acceptability of module and OSPE stations by students ( median 4 , scale 1-5 ) .
CONCLUSIONS	A module to teach drug preparation skills was developed and along with valid and reliable OSPE stations that were acceptable to students .
CONCLUSIONS	The study demonstrated that students acquire better skills through teaching than merely watching these skills in videos .

###25315207
OBJECTIVE	Medication nonadherence is a major obstacle to better control of glucose , blood pressure ( BP ) , and LDL cholesterol in adults with diabetes .
OBJECTIVE	Inexpensive effective strategies to increase medication adherence are needed .
METHODS	In a pragmatic randomized trial , we randomly assigned 2,378 adults with diabetes mellitus who had recently been prescribed a new class of medication for treating elevated levels of glycated hemoglobin ( A1C ) 8 % ( 64 mmol/mol ) , BP 140/90 mmHg , or LDL cholesterol 100 mg/dL , to receive 1 ) one scripted telephone call from a diabetes educator or clinical pharmacist to identify and address nonadherence to the new medication or 2 ) usual care .
METHODS	Hierarchical linear and logistic regression models were used to assess the impact on 1 ) the first medication fill within 60 days of the prescription ; 2 ) two or more medication fills within 180 days of the prescription ; and 3 ) clinically significant improvement in levels of A1C , BP , or LDL cholesterol .
RESULTS	Of the 2,378 subjects , 89.3 % in the intervention group and 87.4 % in the usual-care group had sufficient data to analyze study outcomes .
RESULTS	In intent-to-treat analyses , intervention was not associated with significant improvement in primary adherence , medication persistence , or intermediate outcomes of care .
RESULTS	Results were similar across subgroups of patients defined by age , sex , race/ethnicity , and study site , and when limiting the analysis to those who completed the intended intervention .
CONCLUSIONS	This low-intensity intervention did not significantly improve medication adherence or control of glucose , BP , or LDL cholesterol .
CONCLUSIONS	Wide use of this strategy does not appear to be warranted ; alternative approaches to identify and improve medication adherence and persistence are needed .

###25797743
BACKGROUND	We conducted a prospective trial of BRAF and mitogen-activated protein kinase kinase ( MEK ) targeted therapy in advanced , operable BRAF mutation-positive melanoma to determine feasibility , tumor response rates , and biomarkers of response and resistance .
METHODS	Thirteen patients with locally or regionally advanced BRAF mutation-positive melanoma received dabrafenib 150 mg po bid for 14 days , followed by dabrafenib plus trametinib 2 mg po daily for 14 days before operation .
METHODS	Biopsies and tumor measurements were obtained at baseline and days 14 and 28 .
METHODS	Formalin-fixed paraffin embedded specimens were analyzed with hematoxylin and eosin , Ki-67 , cleaved caspase-3 , CD8 , phosphorylated extracellular signal-regulated kinase ( ERK ) , and phosphorylated MEK immunostains .
RESULTS	Therapy was tolerated well , with toxicity grade 3 in 2 of 13 ( 15 % ) patients .
RESULTS	All 12 patients receiving > 14 days of therapy had substantial reduction in tumor volume ( 65 % at day 14 and 78 % at day 28 ) and underwent resection .
RESULTS	After 14 days of dabrafenib therapy , there was a marked reduction in viable melanoma cells and a CD8 T-cell -- rich infiltrate .
RESULTS	Proliferation of the residual melanoma cells was reduced and apoptosis was increased .
RESULTS	The cells continued to express phosphorylated ERK and phosphorylated MEK consistent with incomplete mitogen-activated protein kinase pathway inhibition .
CONCLUSIONS	Preoperative targeted therapy of advanced BRAF-mutant melanoma is feasible , well tolerated , induces brisk tumor responses , and facilitates correlative science .
CONCLUSIONS	A CD8 T-cell-rich infiltrate indicates a potential immune-mediated mechanism of action .
CONCLUSIONS	Both proliferation and apoptosis were inhibited , but the mitogen-activated protein kinase pathway remained activated , suggesting intrinsic resistance in a subset of tumor cells .
CONCLUSIONS	Additional investigation of the anti-tumor immune response during targeted therapy and the mechanisms of intrinsic resistance can yield novel therapeutic strategies .

###25007689
BACKGROUND	Subarachnoid administration of opioids such as pethidine and fentanyl had been proven safe but that oftramadol has been controversial .
BACKGROUND	Tramadol is cheap and readily available , hence the need to further evaluate its intrathecal safety .
OBJECTIVE	The study aimed at determining the hemodynamic and side effect profile of intrathecal tramadol .
METHODS	One hundred and eighty six ( 186 ) ASA I or II patients scheduled for emergency open appendicectomy under spinal anesthesia were included in the study .
METHODS	Group BF ( n = 62 ) received intrathecal fentanyl 25 microg plus 3 ml of 0.5 % hyperbaric bupivacaine , Group BS ( n = 62 ) received 0.5 ml normal saline plus 3 ml of 0.5 % hyperbaric bupivacaine and Group BT ( n = 62 ) received intrathecal tramadol 25 mg plus 3 ml of 0.5 % hyperbaric bupivacaine .
METHODS	Hemodynamic profile and side effects were monitored intraoperatively and 12 hours postoperatively .
RESULTS	Fifteen ( 24.2 % ) , 13 ( 20.9 % ) and 15 ( 24.5 % ) patients respectively in Groups BF , BS and BT had hypotension ( P = 0.886 ) .
RESULTS	The incidence of postoperative vomiting occurred in 2 patients ( 3.2 % ) in Group BF as compared to 3 patients ( 4.8 % ) in Group BS and 10 patients ( 16.1 % ) in Group BT ( P = 0.016 ) .
RESULTS	No surgeon in Group BF reported dissatisfaction but 18 patients ( 29 % ) in Group BS and 1 patient ( 1.6 % ) in Group BT had their surgeons reporting dissatisfaction ( P = 0.0001 ) .
CONCLUSIONS	This study shows that intrathecal tramadol 25 mg has higher incidence of post operative nausea and vomitting than 25 microg of intrathecal fentanyl but both drugs were safe .

###24345886
CONCLUSIONS	Once-weekly administration of 56.5 g teriparatide improved cortical bone parameters and biomechanical parameters at the proximal femur by CT geometry analysis .
BACKGROUND	The aim of this study was to evaluate the effects of weekly administration of teriparatide [ human PTH ( 1-34 ) ] on bone geometry , volumetric bone mineral density ( vBMD ) , and parameters of bone strength at the proximal femur which were longitudinally investigated using computed tomography ( CT ) .
METHODS	The subjects were a subgroup of a recent , randomly assigned , double-blind study ( 578 subjects ) comparing the anti-fracture efficacy of a once-weekly subcutaneous injection of 56.5 g teriparatide with placebo ( TOWER trial ) .
RESULTS	Sixty-six ambulatory postmenopausal women with osteoporosis were enrolled at 15 study sites having multi-detector row CT , and included women injected with teriparatide ( n = 29 , 74.2 5.1 years ) or with placebo ( n = 37 , 74.8 5.3 years ) .
RESULTS	CT data were obtained at baseline and follow-up scans were performed at 48 and 72 weeks .
RESULTS	The data were analyzed to obtain cross-sectional densitometric , geometric , and biomechanical parameters including the section modulus ( SM ) and buckling ratio ( BR ) of the femoral neck , inter-trochanter , and femoral shaft .
RESULTS	We found that once-weekly teriparatide increased cortical thickness/cross-sectional area ( CSA ) and total area , and improved biomechanical properties ( i.e. , decreasing BR ) at the femoral neck and shaft .
RESULTS	Teriparatide did not change the cortical perimeter .
CONCLUSIONS	Our longitudinal analysis of proximal femur geometry by CT revealed that once-weekly administration of 56.5 g teriparatide improved cortical bone parameters at the femoral neck and shaft and also improved biomechanical parameters .

###24572255
BACKGROUND	Age-related endothelial dysfunction and vascular stiffening are associated with increased cardiovascular ( CV ) risk .
BACKGROUND	Many groups have encouraged goals of 10 000 steps/day or 30 min/day of moderate intensity physical activity ( MPA ) to reduce age-related CV risk .
BACKGROUND	The impact of MPA on the vasculature of older adults remains unclear .
RESULTS	We randomized 114 sedentary older adults ages 50 to 12 weeks of either no intervention ( group 1 ) , a pedometer-only intervention ( group 2 ) , or a pedometer with an interactive website employing strategies to increase the adoption of habitual physical activity ( PA , group 3 ) .
RESULTS	Endothelial function by brachial flow-mediated dilation ( FMD % ) , vascular stiffness by tonometry , step-count by pedometer , and PA intensity/distribution by accelerometer were measured .
RESULTS	Step-count increased in groups 2 ( 51361554 to 95963907 , P < 0.001 ) and 3 ( 54741512 to 81673111 , P < 0.001 ) but not in group 1 ( 49311667 to 54102410 ) .
RESULTS	Both groups 2 and 3 increased MPA 30 min/day .
RESULTS	Only group 3 increased MPA in continuous bouts of 10 minutes ( P < 0.001 ) and improved FMD % ( P = 0.001 ) .
RESULTS	Neither achievement of 10 000 steps/day nor 30 min/day of MPA resulted in improved FMD % .
RESULTS	However , achieving 20 min/day in MPA bouts resulted in improved FMD % .
RESULTS	No changes in vascular stiffness were observed .
CONCLUSIONS	MPA reverses age-related endothelial dysfunction , but may require MPA to be performed in bouts of 10 minutes duration for 20 min/day to be effective .
CONCLUSIONS	Commonly encouraged PA goals do not guarantee improved endothelial function and may not be as effective in reducing CV risk .
BACKGROUND	Clinicaltrials.gov .
BACKGROUND	UNIQUE IDENTIFIER : NCT-01212978 .

###24589938
BACKGROUND	A wide range of effective smoking cessation interventions have been developed to help smokers to quit .
BACKGROUND	Smoking rates remain high , especially among people with a lower level of education .
BACKGROUND	Multiple tailoring adapted to the individual 's readiness to quit and the use of visual messaging may increase smoking cessation .
OBJECTIVE	The results of video and text computer tailoring were compared with the results of a control condition .
OBJECTIVE	Main effects and differential effects for subgroups with different educational levels and different levels of readiness to quit were assessed .
METHODS	During a blind randomized controlled trial , smokers willing to quit within 6 months were assigned to a video computer tailoring group with video messages ( n = 670 ) , a text computer tailoring group with text messages ( n = 708 ) , or to a control condition with short generic text advice ( n = 721 ) .
METHODS	After 6 months , effects on 7-day point prevalence abstinence and prolonged abstinence were assessed using logistic regression analyses .
METHODS	Analyses were conducted in 2 samples : ( 1 ) respondents ( as randomly assigned ) who filled in the baseline questionnaire and completed the first session of the program , and ( 2 ) a subsample of sample 1 , excluding respondents who did not adhere to at least one further intervention session .
METHODS	In primary analyses , we used a negative scenario in which respondents lost to follow-up were classified as smokers .
METHODS	Complete case analysis and multiple imputation analyses were considered as secondary analyses .
RESULTS	In sample 1 , the negative scenario analyses revealed that video computer tailoring was more effective in increasing 7-day point prevalence abstinence than the control condition ( OR 1.45 , 95 % CI 1.09-1 .94 , P = .01 ) .
RESULTS	Video computer tailoring also resulted in significantly higher prolonged abstinence rates than controls among smokers with a low ( ready to quit within 4-6 months ) readiness to quit ( OR 5.13 , 95 % CI 1.76-14 .92 , P = .003 ) .
RESULTS	Analyses of sample 2 showed similar results , although text computer tailoring was also more effective than control in realizing 7-day point prevalence abstinence .
RESULTS	No differential effects were found for level of education .
RESULTS	Complete case analyses and multiple imputation yielded similar results .
CONCLUSIONS	In all analyses , video computer tailoring was effective in realizing smoking cessation .
CONCLUSIONS	Furthermore , video computer tailoring was especially successful for smokers with a low readiness to quit smoking .
CONCLUSIONS	Text computer tailoring was only effective for sample 2 .
CONCLUSIONS	Results suggest that video-based messages with personalized feedback adapted to the smoker 's motivation to quit might be effective in increasing abstinence rates for smokers with diverse educational levels .
BACKGROUND	Netherlands Trial Register : NTR3102 ; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3102 ( Archived by WebCite at http://www.webcitation.org/6NS8xhzUV ) .

###25873046
BACKGROUND	Ban-Lan-Gen ( BLG ) is a traditional Chinese herbal medicine .
BACKGROUND	It has been used for the prevention and treatment of virus-related respiratory diseases such as influenza virus infection .
BACKGROUND	BLG contains some antiviral compounds , but few evidence-based clinical studies have been conducted to assess its efficacy against influenza .
BACKGROUND	We assessed the effects of BLG ( including efficacy and safety ) on the treatment of seasonal influenza in an evidence-based clinical trial .
METHODS	We conducted a randomized , double-blinded , oseltamivir - and placebo-controlled , parallel-design clinical trial .
METHODS	A total of 177 subjects are going to be recruited after satisfying the criteria : ( i ) 18 to 65 years of age ; ( ii ) illness onset within 36 h ; ( 3 ) axillary temperature 38.0 C ; and ( iv ) positive influenza ( type A/B ) virus test .
METHODS	Subjects will be assigned randomly into three groups in equal proportions : oseltamivir treatment , BLG granule treatment , and placebo treatment .
METHODS	Each group receives 5-day treatment and is followed up 1 , 3 , 5 , 7 and 21 days later .
METHODS	Symptoms and patient compliance are recorded , and virus/serum viral antibodies tested .
METHODS	We will use the primary outcome , secondary outcome , and safety indicators to evaluate the efficacy and safety of BLG granules in the treatment of seasonal influenza .
CONCLUSIONS	We have described the first clinical trial for treatment using a single herb against influenza A and B viruses in China .
CONCLUSIONS	We will hold a large-scale clinical trial to comprehensively evaluate the effectiveness and safety of BLG against influenza infection based on the results of this pilot study .
CONCLUSIONS	And this clinical trial will serve as an example for the study of other traditional herbal medicines in evidence-based clinical trials .
BACKGROUND	This study has been registered at ClinicalTrials.gov : NCT02232945 ( 3 September 2014 ) .

###24354833
OBJECTIVE	We evaluated whether a brief , universal , postnatal nurse home-visiting intervention can be implemented with high penetration and fidelity , prevent emergency health care services , and promote positive parenting by infant age 6 months .
METHODS	Durham Connects is a manualized 4 - to 7-session program to assess family needs and connect parents with community resources to improve infant health and well-being .
METHODS	All 4777 resident births in Durham , North Carolina , between July 1 , 2009 , and December 31 , 2010 , were randomly assigned to intervention and control conditions .
METHODS	A random , representative subset of 549 families received blinded interviews for impact evaluation .
RESULTS	Of all families , 80 % initiated participation ; adherence was 84 % .
RESULTS	Hospital records indicated that Durham Connects infants had 59 % fewer infant emergency medical care episodes than did control infants .
RESULTS	Durham Connects mothers reported fewer infant emergency care episodes and more community connections , more positive parenting behaviors , participation in higher quality out-of-home child care , and lower rates of anxiety than control mothers .
RESULTS	Blinded observers reported higher quality home environments for Durham Connects than for control families .
CONCLUSIONS	A brief universal home-visiting program implemented with high penetration and fidelity can lower costly emergency medical care and improve family outcomes .

###25029426
BACKGROUND	Interruption of the renin-angiotensin-aldosterone system prevents incident diabetes in high-risk individuals , although the mechanism remains unclear .
OBJECTIVE	To test the hypothesis that activation of the endogenous renin-angiotensin-aldosterone system or exogenous aldosterone impairs insulin secretion in humans .
METHODS	We conducted a randomized , blinded crossover study of aldosterone vs vehicle and compared the effects of a low-sodium versus a high-sodium diet .
METHODS	Academic clinical research center .
METHODS	Healthy , nondiabetic , normotensive volunteers .
METHODS	Infusion of exogenous aldosterone ( 0.7 g/kg/h for 12.5 h ) or vehicle during low or high sodium intake .
METHODS	Low sodium ( 20 mmol/d ; n = 12 ) vs high sodium ( 160 mmol/d ; n = 17 ) intake for 5-7 days .
METHODS	Change in acute insulin secretory response assessed during hyperglycemic clamps while in sodium balance during a low-sodium vs high-sodium diet during aldosterone vs vehicle .
RESULTS	A low-sodium diet increased endogenous aldosterone and plasma renin activity , and acute glucose-stimulated insulin ( -16.0 5.6 % ; P = .007 ) and C-peptide responses ( -21.8 8.4 % ; P = .014 ) were decreased , whereas the insulin sensitivity index was unchanged ( -1.0 10.7 % ; P = .98 ) .
RESULTS	Aldosterone infusion did not affect the acute insulin response ( +1.8 4.8 % ; P = .72 ) or insulin sensitivity index ( +2.0 8.8 % ; P = .78 ) .
RESULTS	Systolic blood pressure and serum potassium were similar during low and high sodium intake and during aldosterone infusion .
CONCLUSIONS	Low dietary sodium intake reduces insulin secretion in humans , independent of insulin sensitivity .

###24597619
BACKGROUND	A peripheral nerve stimulus can enhance or suppress the evoked response to transcranial magnetic stimulation ( TMS ) depending on the latency of the preceding peripheral nerve stimulation ( PNS ) pulse .
BACKGROUND	Similarly , somatosensory afference from the passively moving limb can transiently alter corticomotor excitability , in a phase-dependent manner .
BACKGROUND	The repeated association of PNS with TMS is known to modulate corticomotor excitability ; however , it is unknown whether repeated passive-movement associative stimulation ( MAS ) has similar effects .
METHODS	In a proof-of-principal study , using a cross-over design , seven healthy subjects received in separate sessions : ( 1 ) TMS ( 120 % of the resting motor threshold-RMT , optimal site for Flexor Carpi Radialis ) with muscle at rest ; ( 2 ) TMS paired with cyclic passive movement during extension cyclic passive movement ( 400 pairs , 1 Hz ) , with the intervention order randomly assigned .
METHODS	Normality was tested using the Kolmogorov-Smirnov test , then compared to pre-intervention baseline using repeated measures ANOVA with a Dunnet multiple comparisons test .
RESULTS	MAS led to a progressive and significant decrease in the motor evoked potential ( MEP ) amplitude over the intervention ( R ( 2 ) = 0.6665 , P < 0.0001 ) , which was not evident with TMS alone ( R ( 2 ) = 0.0068 , P = 0.641 ) .
RESULTS	Post-intervention excitability reduction , only present with MAS intervention , remained for 20 min ( 0-10 min = 68.2 4.9 % , P < 0.05 ; 10-20 min = 73.3 9.7 % , P < 0.05 ) .
CONCLUSIONS	The association of somatosensory afference from the moving limb with TMS over primary motor cortex in healthy subjects can be used to modulate corticomotor excitability , and may have therapeutic implications .

###24874782
BACKGROUND	The objective of this pilot 6-month randomized controlled trial was to determine the effectiveness of an intensive , community-based , group intervention that focused on diet , physical activity , and peer support for reducing weight among urban-dwelling African Americans with comorbid type 2 diabetes and hypertension .
METHODS	Sixty-one participants were randomized into an intervention or control group .
METHODS	The 6-month intervention consisted of 18 group sessions led by a dietitian in a community setting and weekly telephone calls from a peer supporter .
METHODS	The intervention featured culturally tailored nutrition education , behavioral skills training , and social support focused on changes to diet and physical activity .
METHODS	The control group consisted of two 3-hour group sessions of diabetes self-management education taught by a community health worker .
METHODS	Outcome measures were assessed at baseline and 6 months .
METHODS	The primary outcome was achievement of a 5 % weight reduction at 6 months .
METHODS	A secondary outcome was achievement of a 0.5 percentage-point reduction in hemoglobin A1c ( HbA1c ) .
RESULTS	Groups did not differ in achievement of the weight-loss goal .
RESULTS	Intervention participants lost a mean of 2.8 kg ( P = .01 ) ; control participants did not lose a significant amount of weight .
RESULTS	A greater proportion of intervention ( 50.0 % ) than control ( 21.4 % ) participants reduced HbA1c by 0.5 percentage points or more at 6 months ( P = .03 ) .
CONCLUSIONS	The intervention was more effective than usual care ( short-term diabetes education ) at improving glycemic control , but not weight , in low-income African Americans with comorbid diabetes and hypertension .
CONCLUSIONS	A community-based 6-month group class with culturally tailored education , behavioral skills training , and peer support can lead to a clinically significant reduction in HbA1c .

###25035126
BACKGROUND	Mandibular advancement devices ( MADs ) are used to treat obstructive sleep apnoea-hypopnoea syndrome ( OSAHS ) but evidence is lacking regarding their clinical and cost-effectiveness in less severe disease .
OBJECTIVE	To compare clinical - and cost-effectiveness of a range of MADs against no treatment in mild to moderate OSAHS .
METHODS	This open-label , randomised , controlled , crossover trial was undertaken at a UK sleep centre .
METHODS	Adults with Apnoea-Hypopnoea Index ( AHI ) 5 - < 30/h and Epworth Sleepiness Scale ( ESS ) score 9 underwent 6weeks of treatment with three non-adjustable MADs : self-moulded ( SleepPro 1 ; SP1 ) ; semi-bespoke ( SleepPro 2 ; SP2 ) ; fully-bespoke MAD ( bMAD ) ; and 4weeks no treatment .
METHODS	Primary outcome was AHI scored by a polysomnographer blinded to treatment .
METHODS	Secondary outcomes included ESS , quality of life , resource use and cost .
RESULTS	90 patients were randomised and 83 were analysed .
RESULTS	All devices reduced AHI compared with no treatment by 26 % ( 95 % CI 11 % to 38 % , p = 0.001 ) for SP1 , 33 % ( 95 % CI 24 % to 41 % ) for SP2 and 36 % ( 95 % CI 24 % to 45 % , p < 0.001 ) for bMAD .
RESULTS	ESS was 1.51 ( 95 % CI 0.73 to 2.29 , p < 0.001 , SP1 ) to 2.37 ( 95 % CI 1.53 to 3.22 , p < 0.001 , bMAD ) lower than no treatment ( p < 0.001 for all ) .
RESULTS	Compliance was lower for SP1 , which was the least preferred treatment at trial exit .
RESULTS	All devices were cost-effective compared with no treatment at a 20,000 / quality-adjusted life year ( QALY ) threshold .
RESULTS	SP2 was the most cost-effective up to 39,800 / QALY .
CONCLUSIONS	Non-adjustable MADs achieve clinically important improvements in mild to moderate OSAHS and are cost-effective .
CONCLUSIONS	Of those trialled , the semi-bespoke MAD is an appropriate first choice .
BACKGROUND	ISRCTN02309506 .

###24852508
OBJECTIVE	Investigate the effect of a brimless interface design compared with ischial ramus containment ( IRC ) of interfaces when using vacuum-assisted suspension ( VAS ) on transfemoral amputees ( TFAs ) .
METHODS	Randomized experimental crossover .
METHODS	Household , community , and clinic .
METHODS	Unilateral TFAs ( N = 12 enrolled , N = 10 analyzed ) .
METHODS	Mean age : 42.9 years .
METHODS	Mean residual limb length : 60.3 % of the sound side femur length .
METHODS	Participants ' mean time as an amputee : 8.3 years and median AMP score : 43 .
METHODS	( 1 ) IRC VAS interface , and ( 2 ) brimless VAS interface .
METHODS	Average medial wall height for IRC interfaces was 0.7 cm proximal to the distal-most aspect of the ischial tuberosity ( IT ) .
METHODS	The medial wall on the brimless design was an average of 3.3 cm distal to the distal-most aspect of the IT .
METHODS	Spatiotemporal gait parameters , limits of stability , four square step test , and subjective perception using the prosthetic evaluation questionnaire ( PEQ ) .
RESULTS	Step length was significantly improved towards the IRC ( p = 0.04 ) , when calculating degree of asymmetry .
RESULTS	Base of support was significantly narrowed toward the brimless ( p = 0.03 ) .
RESULTS	All subjective measures reached statistical significance in favor of improvement with the brimless design , compared to the IRC .
CONCLUSIONS	The brimless design was equivalent to IRC in most gait and balance outcome measures .
CONCLUSIONS	However , step length was more symmetrical toward the IRC while base of support was narrowed toward the brimless demonstrating mixed inconsistent performance changes .
CONCLUSIONS	Further , the PEQ demonstrated significant subjective improvements in prosthetic related function and quality of life when participants used the brimless design .
CONCLUSIONS	Brimless interface design may be a clinically viable choice .

###24411753
OBJECTIVE	This study assessed changes in cardiovascular disease risk factors among participants in a 12-week behavioral weight loss intervention featuring a commercial format .
METHODS	132 participants were enrolled in a randomized controlled trial of a 12-week group-based lifestyle intervention that involved two structured food plan conditions .
METHODS	Of them , 112 ( 100 women and 12 men , mean BMI = 31.44 2.18 kg/m ( 2 ) ) completed the program with post-treatment assessments .
METHODS	Weight and changes in risk factors ( cholesterol , triglycerides , fasting blood glucose , and blood pressure ) were assessed at pre - and posttreatment .
METHODS	Additionally , changes for each risk factor were examined among participants with baseline values of risk factors beyond recommended cut points .
RESULTS	With no weight loss differences between conditions , analyses used the combined sample .
RESULTS	Participants lost 3.74 3.16 kg ( 4.37 3.71 % of baseline weight ) , and exhibited significant decreases in triglyceride , total cholesterol and LDL-cholesterol levels .
RESULTS	There were trends toward reductions in fasting glucose , systolic blood pressure , and HDL cholesterol .
RESULTS	Among participants with elevated baseline values , significant reductions were seen on all risk factors , with the exception of HDL cholesterol .
CONCLUSIONS	Modest weight loss achieved via a relatively brief , non-intensive intervention using a commercial format can yield significant improvements in cardiovascular disease risk factors , particularly among individuals with initially higher-risk values .

###24661390
OBJECTIVE	Effective non-invasive ventilation ( NIV ) therapy is dependent on optimal ventilator settings to maximize clinical benefit and patient tolerance .
OBJECTIVE	Intelligent volume-assured pressure support ( iVAPS ) is a hybrid mode of servoventilation , providing constant automatic adjustment of pressure support ( PS ) to achieve a target ventilation determined by the patient 's requirements .
OBJECTIVE	In a randomized crossover trial , we tested the hypothesis that iVAPS , with automated selection of ventilator settings , was non-inferior to standard PS ventilation , with settings determined by an experienced health-care professional , for controlling nocturnal hypoventilation in patients naive to NIV .
METHODS	Eighteen patients referred to a ventilator clinic with chronic obstructive or restrictive lung disease and newly diagnosed nocturnal hypoventilation ( 10 male , median ( interquartile range ) : age 54 ( 41-61 ) years , mean daytime PaO2 9.25 ( 8.59-10 .31 ) kPa , - PaCO2 6.38 ( 5.93-6 .65 ) kPa were randomized to iVAPS and standard PS .
METHODS	Polysomnography with transcutaneous CO2 monitoring was performed at baseline and 1 month after each treatment period .
METHODS	Nightly hours of therapy were recorded by the ventilator .
RESULTS	iVAPS delivered a lower median PS compared with standard PS ( 8.3 ( 5.6-10 .4 ) vs 10.0 ( 9.0-11 .4 ) cmH2 O ; P = 0.001 ) for the same ventilatory outcome ( mean overnight : SpO2 96 ( 95-98 ) vs 96 ( 93-97 ) % ; P = 0.13 and PtcCO2 6.5 ( 5.8-6 .8 ) vs 6.2 ( 5.8-6 .9 ) ; P = 0.54 ) .
RESULTS	There was no difference in outcome between ventilator modes for spirometry , respiratory muscle strength , sleep quality , arousals or O2 desaturation index .
RESULTS	Adherence was greater with iVAPS ( 5:40 ( 4:42 -6:49 ) vs 4:20 ( 2:27 -6:17 ) hh : mm/night ; P = 0.004 ) .
CONCLUSIONS	iVAPS servoventilation with automation of ventilation settings is as effective as PS ventilation initiated by a skilled health-care professional in controlling nocturnal hypoventilation and produced better overnight adherence in patients naive to NIV .

###25425502
OBJECTIVE	To evaluate the risk of documented hypoglycaemia with glimepiride versus linagliptin .
METHODS	This was an exploratory analysis of data from a 2-year , randomized , double-blind study of the dipeptidyl peptidase-4 inhibitor linagliptin 5mg once daily ( n = 764 ) versus the sulphonylurea glimepiride 1-4mg once daily ( n = 755 ) in patients with type 2 diabetes uncontrolled by metformin .
METHODS	Patients randomized to glimepiride started on 1mg and after 4weeks were allowed to be individually uptitrated stepwise to glimepiride 4mg if a fasting plasma glucose concentration 6.1 mmol/l was not achieved .
METHODS	Investigator-reported hypoglycaemia was evaluated by dose , over time , and by the degree of glycated haemoglobin ( HbA1c ) reduction .
RESULTS	The percentages of patients with at least one hypoglycaemic event at the individual maximum glimepiride dose were : 1mg , 45.0 % ; 2mg , 50.8 % ; 3mg , 36.1 % ; and 4mg , 27.7 % .
RESULTS	The incidence of hypoglycaemia was higher with glimepiride than with linagliptin ( 36.1 vs. 7.5 % ; p < 0.0001 ) ; after performing sensitivity analyses by excluding events during dose escalation ( weeks0-16 ) , this difference remained significant ( weeks16-104 : 25.8 vs. 5.9 % ; p < 0.0001 ) .
RESULTS	Notably , the incidence of hypoglycaemia was higher with glimepiride than with linagliptin in each quartile of HbA1c change from baseline ( all p < 0.0001 ) ; the incidence of hypoglycaemic episodes was not increased with greater reductions in HbA1c in either group .
RESULTS	In all 4-week intervals across the 2-year study , the incidence of hypoglycaemia was lower with linagliptin than with glimepiride .
CONCLUSIONS	Linagliptin was associated with a lower risk of hypoglycaemia than glimepiride at all dose levels and time intervals , and regardless of change in HbA1c level .

###24734285
BACKGROUND	IgE-mediated allergic rhinitis to grass pollen can successfully be treated with either allergen immunotherapy tablets ( SLIT tablet ) or SQ-standardized subcutaneous immunotherapy ( SCIT ) .
BACKGROUND	The efficacy of these two treatment modalities for grass allergy is comparable , but the immunological mechanisms may differ .
BACKGROUND	ClinicalTrials.gov ID : NCT01889875 .
OBJECTIVE	To compare the immunological changes induced by SQ-standardized SCIT and SLIT tablet .
METHODS	We randomized 40 individuals with grass pollen rhinitis into groups receiving SCIT , SLIT tablet , or neither and followed them for 15 months with regular serum measurements of specific IgE , IgG4 , IgE-blocking factor , facilitated antigen presentation ( FAP ) , and basophil activation test ( BAT ) .
METHODS	Nasal challenges were used to assess changes in nasal sensitivity .
RESULTS	After 15 months of treatment IgG4 , IgE-blocking factor , FAP , and BAT values differed significantly in both SCIT and SLIT-tablet treatment groups when compared to the control group .
RESULTS	Both SCIT and SLIT-tablet groups were significantly different from the control group after 13 months of treatment .
RESULTS	In general , the changes induced by SCIT reached twice that of SLIT tablet , with the exception of specific IgE where SLIT tablet induced initial threefold increase compared with SCIT .
RESULTS	A slight but significant increase in IgE and BAT after season was seen only in the control group .
RESULTS	Significant differences between SCIT and SLIT tablet were observed early , but the differences diminished with the length of treatment , especially for FAP inhibition .
CONCLUSIONS	Both SCIT and SLIT tablet induce significant changes in specific antibodies ( IgE and IgG4 ) and competition assays ( IgE-blocking factor , FAP , and BAT ) .
CONCLUSIONS	Overall , SCIT induced larger ( two - to threefold ) changes than SLIT tablet , with the exception of FAP , where SLIT tablet showed a gradual increase ending at the same level as SCIT .
CONCLUSIONS	Maximal change was generally reached after 3 months ' treatment .

###25216508
OBJECTIVE	Painful diabetic peripheral neuropathy ( PDPN ) is a common complication of diabetes mellitus .
OBJECTIVE	Unfortunately , pharmacological treatment is often partially effective or accompanied by unacceptable side effects , and new treatments are urgently needed .
OBJECTIVE	Small observational studies suggested that spinal cord stimulation ( SCS ) may have positive effects .
METHODS	We performed a multicenter randomized clinical trial in 36 PDPN patients with severe lower limb pain not responding to conventional therapy .
METHODS	Twenty-two patients were randomly assigned to SCS in combination with the best medical treatment ( BMT ) ( SCS group ) and 14 to BMT only ( BMT group ) .
METHODS	The SCS system was implanted only if trial stimulation was successful .
METHODS	Treatment success was defined as 50 % pain relief during daytime or nighttime or '' ( very ) much improved '' for pain and sleep on the patient global impression of change ( PGIC ) scale at 6 months .
RESULTS	Trial stimulation was successful in 77 % of the SCS patients .
RESULTS	Treatment success was observed in 59 % of the SCS and in 7 % of the BMT patients ( P < 0.01 ) .
RESULTS	Pain relief during daytime and during nighttime was reported by 41 and 36 % in the SCS group and 0 and 7 % in the BMT group , respectively ( P < 0.05 ) .
RESULTS	Pain and sleep were '' ( very ) much improved '' in 55 and 36 % in the SCS group , whereas no changes were seen in the BMT group , respectively ( P < 0.001 and P < 0.05 ) .
RESULTS	One SCS patient died because of a subdural hematoma .
CONCLUSIONS	Treatment success was shown in 59 % of patients with PDPN who were treated with SCS over a 6-month period , although this treatment is not without risks .

###25170902
OBJECTIVE	Direct-to-consumer ( DTC ) genetic tests have facilitated easy access to personal genetic information related to health and nutrition ; however , consumer perceptions of the nutritional information provided by these tests have not been evaluated .
OBJECTIVE	The objectives of this study were to assess individual perceptions of personalized nutrition and genetic testing and to determine whether a personalized nutrition intervention modifies perceptions .
METHODS	A double-blind , parallel-group , randomized controlled trial was conducted among healthy men and women aged 20-35 years ( n = 138 ) .
METHODS	Participants in the intervention group ( n = 92 ) were given a report of DNA-based dietary advice and those in the control group ( n = 46 ) were given a general dietary advice report .
METHODS	A survey was completed at baseline and 3 and 12 months after distributing the reports to assess perceptions between the two groups .
RESULTS	No significant differences in perceptions of personalized nutrition and genetic testing were observed between the intervention and control group , so responses of both groups were combined .
RESULTS	As compared to baseline , participant responses increased significantly toward the positive end of a Likert scale at 3 months for the statement ' I am interested in the relationship between diet and genetics ' ( mean change SD : 0.28 0.99 , p = 0.0002 ) .
RESULTS	The majority of participants indicated that a university research lab ( 47 % ) or health care professional ( 41 % ) were the best sources for obtaining accurate personal genetic information , while a DTC genetic testing company received the fewest selections ( 12 % ) .
RESULTS	Most participants ( 56 % ) considered dietitians to be the best source of personalized nutrition followed by medical doctors ( 27 % ) , naturopaths ( 8 % ) and nurses ( 6 % ) .
CONCLUSIONS	These results suggest that perceptions of personalized nutrition changed over the course of the intervention .
CONCLUSIONS	Individuals view a research lab or health care professional as better providers of genetic information than a DTC genetic testing company , and registered dietitians are considered to be the best providers of personalized nutrition advice .

###25487763
BACKGROUND	Until now , there has not been any evaluated , disease-specific education and treatment program for patients with coronary heart disease ( CHD ) in Germany .
BACKGROUND	It is thought that education can improve these patients ' physical activity and quality of life and teach them how to lessen their risk factors , what to do in case of an emergency , and how to assess their own medical treatment .
METHODS	A randomized controlled open intervention trial was carried out from February 2010 to September 2011.196 patients were assigned to receive the intervention ( patient education ) , while 199 were assigned to a control group .
METHODS	In an intention-to-treat analysis , baseline and follow-up data were compared after a mean interval of 220 days .
METHODS	The evaluative instruments included the Freiburg Questionnaire of Physical Activity , the MacNew Heart Disease Quality of Life Questionnaire , questionnaires regarding knowledge about CHD , ergometric performance ability , and the body-mass index .
RESULTS	The patients in the intervention group reported having increased their physical activity by a mean of 9.3 MET/week ( MET = metabolic equivalent of task ) , compared to 2.5 MET/week in the control group ; the difference of 6.8 MET/week was statistically significant ( p = 0.015 ) .
RESULTS	The patients in the intervention group also rated their quality of life higher than those in the control group ( 0.2 0.56 vs. 0.09 0.53 [ mean standard deviation ] , p = 0.056 ) .
RESULTS	They were significantly better informed than patients in the control group about risk factors and about what to do in an emergency .
CONCLUSIONS	Persistently unhealthy lifestyle is a common problem of CHD patients ; the education and treatment program presented here may be a suitable means of improving patients ' lifestyle for secondary prevention .
CONCLUSIONS	Further studies will be needed to document long-term efficacy and to determine whether occasional refresher courses will be needed as well .

###26026105
OBJECTIVE	The present study aimed to compare the outcome of secondary cytoreductive surgery retrospectively in patients with positive and negative Arbeitsgemeinschaft Gynkologische Onkologie ( AGO ) score that were operated on at the Department of Gynecology , Charit Comprehensive Cancer Center , Medical University , between 2006 and 2013 .
METHODS	A total of 209 consecutive patients presenting a first recurrence of epithelial ovarian cancer were enrolled : 139 patients had a positive AGO score , and 70 patients had at least one negative criterion of the AGO score .
METHODS	All patients underwent secondary cytoreductive surgery and data were evaluated retrospectively .
RESULTS	Total macroscopic tumor resection was obtained during secondary cytoreductive surgery in 127 patients ( 61 % ) , 93 ( 67 % ) in the AGO-positive group and 34 ( 48.5 % ) in the AGO-negative group .
RESULTS	Overall ( OS ) and progression-free survival ( PFS ) were identical in both groups of patients when secondary cytoreductive surgery succeeded in achieving complete tumor resection .
RESULTS	PFS was 22 months in AGO-positive patients who were tumor-free after secondary cytoreductive surgery and 21 months in AGO-negative patients with complete resection after secondary cytoreductive surgery .
RESULTS	There were no significant differences in morbidity and mortality rates for both groups .
CONCLUSIONS	AGO score is a useful predictor for operability in patients with a first recurrence of ovarian cancer .
CONCLUSIONS	Patients with negative scores may still have a 50 % chance of achieving optimal tumor resection after secondary cytoreductive surgery .
CONCLUSIONS	This will be a pivotal factor when counseling patients with recurrent disease regarding further management options .

###25062747
BACKGROUND	Obsessive-Compulsive Disorder ( OCD ) is a common chronic psychiatric disorder that constitutes a leading cause of disability .
BACKGROUND	Although Cognitive-Behaviour Therapy ( CBT ) has been shown to be an effective treatment for OCD , this specialised treatment is unavailable to many due to access issues and the social stigma associated with seeing a mental health specialist .
BACKGROUND	Internet-based psychological treatments have shown to provide effective , accessible and affordable treatment for a range of anxiety disorders , and two Randomised Controlled Trials ( RCTs ) have demonstrated the efficacy and acceptability of internet-based CBT ( iCBT ) for OCD , as compared to waitlist or supportive therapy .
BACKGROUND	Although these initial findings are promising , they do not isolate the specific effect of iCBT .
BACKGROUND	This paper details the study protocol for the first randomised control trial evaluating the efficacy of therapist-assisted iCBT for OCD , as compared to a matched control intervention ; internet-based therapist-assisted progressive relaxation training ( iPRT ) .
BACKGROUND	It will aim to examine whether therapist-assisted iCBT is an acceptable and efficacious treatment , and to examine how effectiveness is influenced by patient characteristics .
METHODS	A randomised controlled trial using repeated measures with two arms ( intervention and matched control ) will be used to evaluate the efficacy and acceptability of iCBT for OCD .
METHODS	The RCT will randomise 212 Australian adults with a primary diagnosis of OCD into either the active intervention or control condition , for 12 weeks duration .
METHODS	Outcomes for participants in both study arms will be assessed at baseline and post-intervention .
METHODS	Participants in iCBT will be further assessed at six month follow-up , while participants in the control condition will be crossed over to receive the iCBT intervention and reassessed at post-intervention and six month follow-up .
METHODS	The primary outcome will be clinically significant change in obsessive-compulsive symptom scores .
CONCLUSIONS	This will be the first known therapist assisted internet-based trial of a comprehensive CBT treatment for OCD as compared to a matched control intervention .
CONCLUSIONS	Demonstrating the efficacy of an internet-based treatment for OCD will allow the development of models of care for broad-based access to an evidence-based but complex treatment .

###26062192
OBJECTIVE	To observe the differences in clinical effect on menstrual migraine between subgaleal acupoint injection with metoclopramide and oral administration of medication .
METHODS	Sixty-four patients of menstrual migraine were randomized into a subgaleal acupoint injection group and a medication group , 32 cases in each one .
METHODS	In the subgaleal acupoint injection group , the acupoint injection started 10 days before menstruation .
METHODS	Eight acupoints on the head were selected and injected alternatively in two groups , once every 2 days , 4 treatments made one session and 3 sessions ( 3 menstrual cycles ) were required .
METHODS	In the medication group , flunarizine was applied with oral administration , 2.5 mg each time , once every night .
METHODS	The duration of treatment was 3 months .
METHODS	The analgesic effect , frequency and time of pain attack were observed in 3 and 6 months after treatment in the two groups .
RESULTS	After treatment , VAS scores were lower than those before treatment in the two groups ( P < 0.01 , P < 0.05 ) , the attack frequency and pain time were all reduced as compared with those before treatment ( all P < 0.01 ) .
RESULTS	After treatment , VAS score , the frequency and time of pain attack in the subgaleal acupoint injection group were improved significantly as compared with the medication group ( all P < 0.01 ) .
CONCLUSIONS	The subgaleal acupoint injection with metoclopramide achieves the superior preventive effect in clinical treatment of menstrual migraine as compared with flunarizine .

###24745198
OBJECTIVE	The aim of this study was to compare the effectiveness of a new index of perceived mental workload , the Multiple Resource Questionnaire ( MRQ ) , with the standard measure of workload used in the study of vigilance , the NASA Task Load Index ( NASA-TLX ) .
BACKGROUND	The NASA-TLX has been used extensively to demonstrate that vigilance tasks impose a high level of workload on observers .
BACKGROUND	However , this instrument does not specify the information-processing resources needed for task performance .
BACKGROUND	The MRQ offers a tool to measure the workload associated with vigilance assignments in which such resources can be identified .
METHODS	Two experiments were performed in which factors known to influence task demand were varied .
METHODS	Included were the detection of stimulus presence or absence , detecting critical signals by means of successive-type ( absolute judgment ) and simultaneous-type ( comparative judgment ) discriminations , and operating under multitask vs. single-task conditions .
RESULTS	The MRQ paralleled the NASA-TLX in showing that vigilance tasks generally induce high levels of workload and that workload scores are greater in detecting stimulus absence than presence and in making successive as compared to simultaneous-type discriminations .
RESULTS	Additionally , the MRQ was more effective than the NASA-TLX in reflecting higher workload in the context of multitask than in single-task conditions .
RESULTS	The resource profiles obtained with MRQ fit well with the nature of the vigilance tasks employed , testifying to the scale 's content validity .
CONCLUSIONS	The MRQ may be a meaningful addition to the NASA-TLX for measuring the workload of vigilance assignments .
CONCLUSIONS	By uncovering knowledge representation associated with different tasks , the MRQ may aid in designing operational vigilance displays .

###25629739
BACKGROUND	The effects of less-tight versus tight control of hypertension on pregnancy complications are unclear .
METHODS	We performed an open , international , multicenter trial involving women at 14 weeks 0 days to 33 weeks 6 days of gestation who had nonproteinuric preexisting or gestational hypertension , office diastolic blood pressure of 90 to 105 mm Hg ( or 85 to 105 mm Hg if the woman was taking antihypertensive medications ) , and a live fetus .
METHODS	Women were randomly assigned to less-tight control ( target diastolic blood pressure , 100 mm Hg ) or tight control ( target diastolic blood pressure , 85 mm Hg ) .
METHODS	The composite primary outcome was pregnancy loss or high-level neonatal care for more than 48 hours during the first 28 postnatal days .
METHODS	The secondary outcome was serious maternal complications occurring up to 6 weeks post partum or until hospital discharge , whichever was later .
RESULTS	Included in the analysis were 987 women ; 74.6 % had preexisting hypertension .
RESULTS	The primary-outcome rates were similar among 493 women assigned to less-tight control and 488 women assigned to tight control ( 31.4 % and 30.7 % , respectively ; adjusted odds ratio , 1.02 ; 95 % confidence interval [ CI ] , 0.77 to 1.35 ) , as were the rates of serious maternal complications ( 3.7 % and 2.0 % , respectively ; adjusted odds ratio , 1.74 ; 95 % CI , 0.79 to 3.84 ) , despite a mean diastolic blood pressure that was higher in the less-tight-control group by 4.6 mm Hg ( 95 % CI , 3.7 to 5.4 ) .
RESULTS	Severe hypertension ( 160/110 mm Hg ) developed in 40.6 % of the women in the less-tight-control group and 27.5 % of the women in the tight-control group ( P < 0.001 ) .
CONCLUSIONS	We found no significant between-group differences in the risk of pregnancy loss , high-level neonatal care , or overall maternal complications , although less-tight control was associated with a significantly higher frequency of severe maternal hypertension .
CONCLUSIONS	( Funded by the Canadian Institutes of Health Research ; CHIPS Current Controlled Trials number , ISRCTN71416914 ; ClinicalTrials.gov number , NCT01192412 . )

###25095797
BACKGROUND	The menopausal transition ( MT ) is a biological inevitability for all ageing women that can be associated with changes in mood , including depressive symptoms .
BACKGROUND	There is tentative evidence that women who develop depression during the MT have greater risk of subsequent depressive episodes , as well as increased health morbidity and mortality .
BACKGROUND	Thus , preventing depression during the MT could enhance both current and the future health and well-being of women .
BACKGROUND	This study aims to test the efficacy of a client-centred health promotion intervention to decrease the 12-month incidence of clinically significant symptoms of depression among women undergoing the MT.
METHODS	This randomised controlled trial will recruit 300 women undergoing the MT living in the Perth metropolitan area .
METHODS	They will be free of clinically significant symptoms of depression and of psychotic or bipolar disorders .
METHODS	Consenting participants will be stratified for the presence of subsyndromal symptoms of depression and then randomly assigned to the intervention or control group .
METHODS	The intervention will consist of eight telephone health promotion sessions that will provide training in problem solving and education about the MT , healthy ageing , depression and anxiety , and management of chronic health symptoms and problems .
METHODS	The primary outcome of interest is the onset of a major depressive episode according the DSM-IV-TR criteria during the 12-month follow-up or of clinically significant symptoms of depression , as established by a score of 15 or greater on the Patient Health Questionnaire ( PHQ-9 ) .
METHODS	Secondary outcomes of interest include changes in the severity of symptoms of depression and anxiety ( Hospital Anxiety and Depression Scale , HADS ) , quality of life ( Short Form Health Survey , SF-12 ) , and lifestyle .
CONCLUSIONS	Current evidence shows that depressive symptoms and disorders are leading causes of disability worldwide , and that they are relatively common during the MT. This study will use a multifaceted health promotion intervention with the aim of preventing depression in these women .
CONCLUSIONS	If successful , the results of this trial will have implications for the management of women undergoing the MT.
BACKGROUND	Australian and New Zealand Clinical Trials Registry ACTRN12613000724774 .
BACKGROUND	Date registered : 1 July 2013 .

###24450931
BACKGROUND	The UK has one of the highest fatality rates for deaths from fire-related injuries in children aged 0-14years ; these injuries have the steepest social gradient of all injuries in the UK .
BACKGROUND	Children 's centres provide children under five years old and their families with a range of services and information , including home safety , but their effectiveness in promoting injury prevention has yet to be evaluated .
BACKGROUND	We developed a fire prevention intervention for use in children 's centres comprising an Injury Prevention Briefing ( IPB ) which provides evidence on what works and best practice from those running injury prevention programmes , and a facilitation package to support implementation of the IPB .
BACKGROUND	This protocol describes the design and methods of a trial evaluating the effectiveness and cost-effectiveness of the IPB and facilitation package in promoting fire prevention .
METHODS	Pragmatic , multicentre cluster randomised controlled trial , with a nested qualitative study , in four study centres in England .
METHODS	Children 's centres in the most disadvantaged areas will be eligible to participate and will be randomised to one of three treatment arms comprising : IPB with facilitation package ; IPB with no facilitation package ; usual care ( control ) .
METHODS	The primary outcome measure will be the proportion of families who have a fire escape plan at follow-up .
METHODS	Eleven children 's centres per arm are required to detect an absolute difference in the percentage of families with a fire escape plan of 20 % in either of the two intervention arms compared with the control arm , with 80 % power and a 5 % significance level ( 2-sided ) , an intraclass correlation coefficient of 0.05 and assuming outcomes are assessed on 20 families per children 's centre .
METHODS	Secondary outcomes include the assessment of the cost-effectiveness of the intervention , other fire safety behaviours and factors associated with degree of implementation of the IPB .
CONCLUSIONS	This will be the first trial to develop and evaluate a fire prevention intervention for use in children 's centres in the UK .
CONCLUSIONS	Its findings will be generalisable to children 's centres in the most disadvantaged areas of the UK and may also be generalisable to similar interventions to prevent other types of injury .
BACKGROUND	http://NCT01452191 ( date of registration : 13/10/2011 ) .

###25322173
OBJECTIVE	The Cornea Donor Study ( CDS ) showed that donor age is not a factor in survival of most penetrating keratoplasties for endothelial disease .
OBJECTIVE	Secondary analyses confirm the importance of surgical indication and presence of glaucoma in outcomes at 10 years .
OBJECTIVE	To assess the relationship between donor and recipient factors and corneal graft survival in the CDS .
METHODS	Multicenter prospective , double-masked , controlled clinical trial conducted at 80 clinical sites .
METHODS	One hundred five surgeons enrolled 1090 participants undergoing corneal transplant for a moderate-risk condition , principally Fuchs dystrophy or pseudophakic or aphakic corneal edema ( PACE ) .
METHODS	Forty-three eye banks provided corneas .
METHODS	Corneas from donors younger than 66 years and donors 66 years or older were assigned , masked to donor age .
METHODS	Surgery and postoperative care were performed according to the surgeons ' usual routines .
METHODS	Participants were followed up for as long as 12 years .
METHODS	Graft failure , defined as a regrafting procedure or a cloudy cornea for 3 consecutive months .
RESULTS	The 10-year cumulative probability of graft failure was higher in participants with PACE than in those with Fuchs dystrophy ( 37 % vs 20 % ; hazard ratio [ HR ] , 2.1 [ 99 % CI , 1.4-3 .0 ] ; P < .001 ) and in participants with a history of glaucoma before penetrating keratoplasty , particularly with prior glaucoma surgery ( 58 % with prior glaucoma surgery and use of medications to lower intraocular pressure at the time of surgery vs 22 % with no history of glaucoma surgery or medication use ; HR , 4.1 [ 99 % CI , 2.2-7 .5 ] ; P < .001 ) .
RESULTS	We found trends toward increased graft failure in recipients who were 70 years or older compared with those younger than 60 years ( 29 % vs 19 % ; HR , 1.2 [ 99 % CI , 0.7-2 .1 ] ; P = .04 ) or were African American ( HR , 1.5 ; P = .11 ) or who had a history of smoking ( 35 % vs 24 % ; HR , 1.6 [ 99 % CI , 0.9-2 .8 ] ; P = .02 ) .
RESULTS	Lower endothelial cell density ( ECD ) and higher corneal thickness ( CT ) at 6 months ( 6 % vs 41 % for ECD 2700 vs < 1700 cells/mm2 [ P < .001 ] ; 14 % vs 36 % for CT < 500 vs 600 m [ P = .001 ] ) , 1 year ( 4 % vs 39 % for ECD 2700 vs < 1700 cells/mm2 [ P < .001 ] ; 18 % vs 28 % for CT < 500 vs 600 m [ P = .04 ] ) , and 5 years ( 2 % vs 29 % for ECD 1500 vs < 500 cells/mm2 [ P < .001 ] ; 7 % vs 34 % for CT < 550 vs 650 m [ P < .001 ] ) were associated with subsequent graft failure .
CONCLUSIONS	Most penetrating corneal grafts for Fuchs dystrophy or PACE remain clear at 10 years .
CONCLUSIONS	The risk for failure is greater for graft recipients with PACE and those with a history of glaucoma .
CONCLUSIONS	Measurements of ECD and CT during the course of postkeratoplasty follow-up are associated with a risk for failure .
CONCLUSIONS	However , even with very low ECD and high CT at 5 years , most corneas remain clear at 10 years .

###25358227
BACKGROUND	Digital nerve blocks are commonly used as effective techniques of anaesthesia to allow a variety of surgical procedures performed on digits .
BACKGROUND	This study was conducted to compare the efficacy of volar subcutaneous single injection block and the traditional dorsal two injections digital block .
METHODS	This randomized controlled trial was conducted at Plastic and Reconstructive Surgery Department , Hayatabad Medical Complex Peshawar from December .
METHODS	2009-10 .
METHODS	A total of 126 patients with pathology distal to the first palmer digital crease divided into two equal groups .
METHODS	Group A received volar subcutaneous digital block while group B dorsal two injections block .
METHODS	Efficacy of digital block was measured in terms of time of onset of anaesthesia , which was the total time duration after administering local anaesthetic to loss of pinprick sensation and total duration of anaesthesia , which was defined as the time period from onset of block ( loss of pinprick sensation ) till the appearance of pain which required additional local anaesthetic or postoperative analgesia .
RESULTS	A total of 126 patients were studied , 63 in each group .
RESULTS	Of the total patients , 102 ( 81 % ) were male and 24 ( 19 % ) female with a mean age of 27 4.2 years ( range 17-60 years ) .
RESULTS	The mean time of onset of anaesthesia from injection till the loss of pin prick sensation was 3.32 0.42 minutes for volar single injection group and 4.53 minutes 0.57 minutes for dorsal two injections group ( p = 0.049 ) .
RESULTS	Similarly the mean total duration of anaesthesia for the volar subcutaneous group was 271.9 29.34 minutes while for the dorsal two injections group , it was 229.52 28.82 minutes ( p = 0.415 ) .
CONCLUSIONS	Single injection volar subcutaneous digital block provides faster onset of anaesthesia , produces predictable , consistent dense anaesthesia of all of the fingers with the help of single injection prick .

###24281271
OBJECTIVE	Pain is underrecognized and undermanaged in older adults with dementia .
OBJECTIVE	Because dementia patients have a diminished capacity to communicate discomfort , untreated pain may be expressed in the form of behavioral and psychiatric symptoms .
OBJECTIVE	The goal of the present study was to examine the relationship between pain and behavioral and psychiatric symptoms of dementia in community-residing older adults from the perspective of the family caregiver .
METHODS	Dyads composed of 272 dementia patients , and their family caregivers were assessed to determine dementia patient 's mental status ; family caregiver 's assessment of care recipient 's pain , functional dependence , and number of behavioral symptoms ; analgesic use ; and demographic information .
RESULTS	Hierarchical multiple regression analysis controlling for age , marital status , race , functional disability , and analgesic use showed that pain explained a small but significant percent of variance in the number of behavioral symptoms ( 3 % , P < 0.001 ) .
RESULTS	Pain had a stronger influence on the number of behavioral and psychiatric symptoms of dementia among those with severe cognitive impairment ( F1 ,69 = 11.75 , P < 0.001 ) compared with those with low to moderate cognitive impairment ( F1 ,199 = 4.543 , P = 0.034 . )
CONCLUSIONS	The findings indicate that pain is a risk factor for behavioral symptoms in individuals with dementia and suggest that pain is a more significant predictor of behavior for individuals with severe dementia , compared with those with mild/moderate stage dementia .
CONCLUSIONS	These results reinforce the importance of proper pain assessment and its management as part of dementia care planning .

###24915873
BACKGROUND	T-cell infiltration in estrogen receptor ( ER ) - negative breast tumours has been associated with longer survival .
BACKGROUND	To investigate this association and the potential of tumour T-cell infiltration as a prognostic and predictive marker , we have conducted the largest study of T cells in breast cancer to date .
METHODS	Four studies totalling 12 439 patients were used for this work .
METHODS	Cytotoxic ( CD8 + ) and regulatory ( forkhead box protein 3 , FOXP3 + ) T cells were quantified using immunohistochemistry ( IHC ) .
METHODS	IHC for CD8 was conducted using available material from all four studies ( 8978 samples ) and for FOXP3 from three studies ( 5239 samples ) - multiple imputation was used to resolve missing data from the remaining patients .
METHODS	Cox regression was used to test for associations with breast cancer-specific survival .
RESULTS	In ER-negative tumours [ triple-negative breast cancer and human epidermal growth factor receptor 2 ( human epidermal growth factor receptor 2 ( HER2 ) positive ) ] , presence of CD8 + T cells within the tumour was associated with a 28 % [ 95 % confidence interval ( CI ) 16 % to 38 % ] reduction in the hazard of breast cancer-specific mortality , and CD8 + T cells within the stroma with a 21 % ( 95 % CI 7 % to 33 % ) reduction in hazard .
RESULTS	In ER-positive HER2-positive tumours , CD8 + T cells within the tumour were associated with a 27 % ( 95 % CI 4 % to 44 % ) reduction in hazard .
RESULTS	In ER-negative disease , there was evidence for greater benefit from anthracyclines in the National Epirubicin Adjuvant Trial in patients with CD8 + tumours [ hazard ratio ( HR ) = 0.54 ; 95 % CI 0.37-0 .79 ] versus CD8-negative tumours ( HR = 0.87 ; 95 % CI 0.55-1 .38 ) .
RESULTS	The difference in effect between these subgroups was significant when limited to cases with complete data ( P heterogeneity = 0.04 ) and approached significance in imputed data ( P heterogeneity = 0.1 ) .
CONCLUSIONS	The presence of CD8 + T cells in breast cancer is associated with a significant reduction in the relative risk of death from disease in both the ER-negative [ supplementary Figure S1 , available at Annals of Oncology online ] and the ER-positive HER2-positive subtypes .
CONCLUSIONS	Tumour lymphocytic infiltration may improve risk stratification in breast cancer patients classified into these subtypes .
CONCLUSIONS	NEAT ClinicalTrials.gov : NCT00003577 .

###24512527
OBJECTIVE	To study the influence of adjuvant androgen suppression and bisphosphonates on incident vertebral and non-spinal fracture rates and bone mineral density ( BMD ) in men with locally advanced prostate cancer .
METHODS	Between 2003 and 2007 , 1071 men with locally advanced prostate cancer were randomly allocated , using a 2 2 trial design , to 6 months i.m. leuprorelin ( androgen suppression [ AS ] ) before radiotherapy alone 12 months additional leuprorelin 18 months zoledronic acid ( ZdA ) , commencing at randomization .
METHODS	The main endpoint was incident thoraco-lumbar vertebral fractures , which were assessed radiographically at randomization and at 3 years , then reassessed by centralized review .
METHODS	Subsidiary endpoints included incident non-spinal fractures , which were documented throughout follow-up , and BMD , which was measured in 222 subjects at baseline , 2 years and 4 years .
RESULTS	Incident vertebral fractures at 3 years were observed in 132 subjects .
RESULTS	Their occurrence was not increased by 18 months ' AS , nor reduced by ZdA .
RESULTS	Incident non-spinal fractures occurred in 72 subjects and were significantly related to AS duration but not to ZdA .
RESULTS	Osteopenia and osteoporosis prevalence rates at baseline were 23.4 and 1.4 % , respectively , at the hip .
RESULTS	Treatment for 6 and 18 months with AS caused significant reductions in hip BMD at 2 and 4 years ( P < 0.01 ) and ZdA prevented these losses at both time points .
CONCLUSIONS	In an AS-nave population , 18 months of ZdA treatment prevented the sustained BMD losses caused by 18 months of AS treatment ; however , the study power was insufficient to show that AS duration or ZdA influenced vertebral fracture rates .

###25130289
BACKGROUND	Febrile neutropenia ( FN ) is a common and serious complication of cancer chemotherapy associated with significant morbidity and mortality .
BACKGROUND	Cefozopran ( CZOP ) is a potential candidate for empirical monotherapy in FN .
BACKGROUND	However , studies on the use of CZOP as empirical treatment for pediatric patients with FN are quite limited .
BACKGROUND	The purpose of this study was to compare the efficacy and safety of CZOP with cefepime ( CFPM ) empirical monotherapy in pediatric cancer patients with FN .
METHODS	A total of 64 patients with 224 episodes of FN were randomly assigned to receive antibiotic therapy with either CZOP ( 100 mg/kg/day ) or CFPM ( 100 mg/kg/day ) .
METHODS	Of these episodes , 223 were considered eligible for the study .
METHODS	Success was defined as resolution of febrile episodes and clinical signs of infection within 120 hr following the start of antibiotic therapy .
RESULTS	The success rate was not significantly different between the CZOP ( 64.0 % ) and CFPM ( 56.3 % ) groups ( P = 0.275 ) .
RESULTS	Duration of fever , duration of antibiotic therapy , and the success rate in patients with blood stream infection did not differ between the two groups .
RESULTS	There was no infection-related mortality in the study period .
CONCLUSIONS	Both CZOP and CFPM as monotherapy appear to be effective and safe in pediatric patients .
CONCLUSIONS	This study suggests that CZOP has satisfactory efficacy and is well tolerated as initial empirical therapy for pediatric cancer patients with FN .

###24280382
BACKGROUND	Obstructive sleep apnea ( OSA ) relates to overnight rostral fluid shift , possibly because fluid accumulation around the pharynx increases pharyngeal resistance ( Rph ) .
BACKGROUND	We hypothesised that Rph will increase more in men with than without OSA in response to rostral fluid redistribution .
METHODS	Seventeen men with , and 12 without OSA were randomized to lower body positive pressure ( LBPP ) for 15min or control , then crossed over .
METHODS	Leg fluid volume ( LFV ) and Rph were measured before and after each period .
RESULTS	LBPP displaced similar amounts of fluid from the legs in both groups .
RESULTS	However , compared to the non-OSA group , Rph increased significantly more during LBPP in the OSA group ( -0.382.87 vs. 2.522.94 cmH2O/l/s , p = 0.016 ) .
RESULTS	Change in Rph during LBPP correlated directly with baseline Rph in the OSA group , but inversely in the non-OSA group .
CONCLUSIONS	OSA patients have increased susceptibility to pharyngeal obstruction in response to rostral fluid redistribution , which could predispose to pharyngeal collapse during sleep .

###24576509
OBJECTIVE	To investigate whether a virtual reality simulator ( LapSim ) and traditional box trainer are effective tools for the acquisition of basic laparoscopic skills , and whether the LapSim is superior to the box trainer in surgical education .
METHODS	In a study at Ege University School of Medicine , Izmir , Turkey , between September 2008 and March 2013 , 40 first - and second-year residents were randomized to train via the LapSim or box trainer for 4 weeks , and 20 senior residents were allocated to a control group .
METHODS	All 3 groups performed laparoscopic bilateral tubal ligation .
METHODS	Video records of each operation were assessed via the general rating scale of the Objective Structured Assessment of Laparoscopic Salpingectomy and by operation time in seconds .
RESULTS	Compared with the control group , the LapSim and box trainer groups performed significantly better in total score ( P < 0.01 and P < 0.01 , respectively ) and time ( P = 0.03 and P = 0.01 , respectively ) .
RESULTS	There were no differences between the LapSim and box trainer groups .
CONCLUSIONS	Novice residents who trained on a LapSim or box trainer performed better live laparoscopies than residents who trained via standard clinical surgical education .
CONCLUSIONS	Training with a virtual reality simulator or box trainer should be considered before actual laparoscopic procedures are carried out .

###25319802
BACKGROUND	Acupuncture has been used in China to treat tinnitus for a long time .
BACKGROUND	There is debate as to whether or not De Qi is a key factor in achieving the efficacy of acupuncture .
BACKGROUND	However , there is no sufficient evidence obtained from randomized controlled trials to confirm the role of De Qi in the treatment of acupuncture for tinnitus .
BACKGROUND	This study aims to identify the effect of De Qi for patients who receive acupuncture to alleviate tinnitus by a prospective , double-blind , randomized , sham-controlled trial .
METHODS	This study compares two acupuncture groups ( with or without manipulation ) in 292 patients with a history of subjective tinnitus .
METHODS	The trial will be conducted in the Teaching Hospital of Chengdu University of Traditional Chinese Medicine .
METHODS	In the study , the patients will be randomly assigned into two groups according to a computer-generated randomization list and assessed prior to treatment .
METHODS	Then , they will receive 5 daily sessions of 30 minutes each time for 4 consecutive weeks and undergo a 12-week follow-up phase .
METHODS	The administration of acupuncture follows the guidelines for clinical research on acupuncture ( WHO Regional Publication , Western Pacific Series Number 15 , 1995 ) , and is performed double-blind by physicians well-trained in acupuncture .
METHODS	The measures of outcome include the subjective symptoms scores and quantitative sensations of De Qi evaluated by Visual Analog Scales ( VAS ) and the Chinese version of the ` modified ' Massachusetts General Hospital Acupuncture Sensation Scale ( C-MMASS ) .
METHODS	Furthermore , adverse events are recorded and analyzed .
METHODS	If any subjects are withdrawn from the trial , intention-to-treat analysis ( ITT ) and per-protocol ( PP ) analysis will be performed .
CONCLUSIONS	The key features of this trial include the randomization procedures , large sample and the standardized protocol to evaluate De Qi qualitatively and quantitatively in the treatment of acupuncture for tinnitus .
CONCLUSIONS	The trial will be the first study with a high evidence level in China to assess the efficacy of De Qi in the treatment of tinnitus in a randomized , double-blind , sham-controlled manner .
BACKGROUND	Chinese Clinical Trial Registry : ChiCTR-TRC-14004720 ( 6 May 2014 ) .

###25464565
OBJECTIVE	To evaluate the protective effects of oral administration of D-methionine tablets on noise-induced hearing impairment .
METHODS	Two hundred and three volunteers were recruited and randomly divided into two groups : experimental group ( n = 113 ) and control group ( n = 90 ) .
METHODS	The subjects received oral administration of D-methionine tablets in the experimental group and placebo in the control group before noise exposure .
METHODS	Routine audiometric evaluation and ABR testing were performed and recorded before and after noise exposure .
METHODS	The statistical analysis was carried out with SPSS 11.0 .
RESULTS	There were no differences in auditory threshold and I-V interpeak latency pre-noise exposure ( P > 0.05 ) , however , there were statistically significant differences between two groups 1 d , 7 d after noise exposure ( P < 0.01 and P < 0.05 ) .
RESULTS	In-respective-group , there were statistically significant differences between before and 1 d after noise exposure ( P < 0.05 and P < 0.01 ) , however , no difference was noted between before and 7 d after noise exposure in the experimental group ( P > 0.05 ) .
CONCLUSIONS	The protective effects of D-methionine tablets were prominent on the noise-induced hearing impairment .
CONCLUSIONS	Further studies regarding the optimal time of D-methionine administration will be recommended in the future .

###25172229
BACKGROUND	Non-extensive superficial partial thickness burns constitute a major proportion of burns .
BACKGROUND	Conventional treatment involves regular changing of absorptive dressings including the application of a topical antimicrobial , commonly silver sulfadiazine .
BACKGROUND	A systematic review has found insufficient evidence to support or refute such antimicrobial prophylaxis .
BACKGROUND	Another review compared silver sulfadiazine dressings with other occlusive and non-antimicrobial dressings and found insufficient evidence to guide practice .
BACKGROUND	Other research has suggested that dressings with petrolatum gel are as effective as silver sulfadiazine .
METHODS	Single-center , randomized , controlled parallel group trial comparing conventional silver sulfadiazine dressings with treatment with petrolatum gel alone .
METHODS	Consenting adults 18-45 years old with superficial partial thickness burns10 % total body surface area seen within 24h of the injury were randomized to daily dressing either with petrolatum gel without top dressings or conventional silver sulfadiazine treatment with gauze dressings .
METHODS	Primary outcomes were blinded assessment of time to complete re-epithelialization , wound infection or allergic contact dermatitis .
METHODS	Secondary outcomes included assessment of ease , time and pain of dressing changes .
RESULTS	26 patients were randomized to petrolatum and 24 to silver sulfadiazine dressings .
RESULTS	Follow up data available for 19 in each group .
RESULTS	Mean time to re-epithelialization was 6.2 days ( SD 2.8 ) in the petrolatum group and 7.8 days ( SD 2.1 ) in the silver sulfadiazine group ( p = 0.050 ) .
RESULTS	No wound infection or dermatitis was observed in either group .
RESULTS	Scores for adherence to wound , ease of dressing removal and time required to change dressings were significantly better in the petrolatum treatment arm ( p < 0.01 ) .
CONCLUSIONS	Petrolatum gel without top dressings may be at least as effective as silver sulfadiazine gauze dressings with regard to time to re-epithelialization , and incidence of infection and allergic contact dermatitis .
CONCLUSIONS	Petrolatum gel appears to be an effective , affordable and widely available alternative in the treatment of minor superficial partial thickness burns in adults .

###25345731
BACKGROUND	Studies have demonstrated that both pain and opioids have actions on the central nervous system that may interfere with cognitive function , but their effects have mainly been analysed separately and not as an integrated process .
OBJECTIVE	The objective of this study is to test two hypotheses : ( 1 ) the analgesic effect of opioids improves cognitive function by decreasing pain , and ( 2 ) pain antagonizes cognitive effects of opioids .
METHODS	Randomized , placebo-controlled , crossover study .
METHODS	Three experiments were conducted with 22 healthy males .
METHODS	Sustained attention , memory and motor function/attention/mental flexibility were evaluated by continuous reaction time ( CRT ) , verbal fluency test ( VFT ) and trail making test-B ( TMT-B ) , respectively .
METHODS	In the 1st experiment , the cognitive effects of experimental tonic pain of mild and moderate intensities produced by a computer-controlled pneumatic tourniquet cuff were assessed ; in the 2nd , the effects of saline solution and remifentanil were assessed in the absence of pain ; and in the 3rd experiment , the cognitive effects of moderate pain intensity relieved by remifentanil infusion were assessed followed by increasing pain to moderate intensity during a constant remifentanil infusion .
RESULTS	The first two experiments demonstrated that pain and remifentanil impaired CRT .
RESULTS	In the 3rd experiment , remifentanil infusion relieving pain significantly impaired CRT and further deterioration was noted following increasing pain intensity .
CONCLUSIONS	Pain and remifentanil seemed to have additive deleterious cognitive effects .
CONCLUSIONS	This study represents an initial step to enhance our basic understanding of some of the cognitive effects following a painful stimulus and an opioid infusion separately and combined in a sequence comparable to clinical settings .

###24929350
OBJECTIVE	We sought to determine the feasibility of conducting percutaneous coronary intervention ( PCI ) in high-risk acute coronary syndrome ( ACS ) patients utilising the REG1 system consisting of pegnivacogin , an aptameric factor IXa inhibitor , and its controlling agent anivamersen .
RESULTS	In RADAR , ACS patients were randomised to pegnivacogin 1 mg/kg with 25 % , 50 % , 75 % , or 100 % anivamersen reversal or unfractionated heparin .
RESULTS	Of the 640 patients randomised , 388 ( 61 % ) underwent PCI .
RESULTS	Major modified ACUITY 30-day bleeding rates were 18 % ( 25 % reversal ) , 12 % ( 50 % reversal ) , 9 % ( 75 % reversal ) , and 7 % ( 100 % reversal ) , compared with 11 % with heparin .
RESULTS	The corresponding total bleeding rates were 68 % , 39 % , 35 % , 34 % , and 38 % ( heparin ) .
RESULTS	Ischaemic events were less frequent in those receiving pegnivacogin versus heparin ( 4.4 % vs. 7.3 % , p = 0.3 ) .
RESULTS	Thirty-day urgent TVR ( 1.1 % vs. 0.9 % , p = 1.0 ) , myocardial infarction ( 4.0 % vs. 6.4 % , p = 0.3 ) , and angiographic complication ( 11.2 % and 10.8 % , p = 0.9 ) rates were similar with pegnivacogin and heparin .
RESULTS	There were no incidences of clot formation on guidewires or catheters .
CONCLUSIONS	High-level factor IXa inhibition in ACS patients undergoing PCI , with at least 50 % reversal , has a favourable bleeding profile and appears effective at suppressing ischaemic events and thrombotic complications .
CONCLUSIONS	Larger phase trials in PCI are warranted .
BACKGROUND	ClinicalTrials.gov NCT00932100 .

###25573272
BACKGROUND	Female pattern hair loss is a frequent and distressing condition .
OBJECTIVE	To evaluate vs. control , the effects on hair loss of a 6-month supplementation with specific omega 3 & 6 and antioxidants .
METHODS	One hundred and twenty healthy female subjects participated in this 6-month , randomized , comparative study .
METHODS	The primary endpoint was the change in hair density evaluated on standardized photographs .
METHODS	Secondary endpoints included changes in telogen hair percentage and diameter distribution of anagen hair ( > 40m vs. 40m ) measured by trichogram .
METHODS	Overall changes in hair density and diameter were also measured by trichometer and by subjects ' self-assessment .
RESULTS	After 6 months of treatment , photograph assessment demonstrated a superior improvement in the supplemented group ( P < 0.001 ) .
RESULTS	The telogen hair percentage was significantly ( P < 0.001 ) reduced in the supplemented group .
RESULTS	The proportion of nonvellus anagen hair ( > 40m ) increased compared to the control group .
RESULTS	The trichometer index increased in the supplemented group , while it decreased in the control group .
RESULTS	A large majority of supplemented subjects reported a reduction in hair loss ( 89.9 % of subjects at 6months ) , as well as an improvement in hair diameter ( 86.1 % ) and hair density ( 87.3 % ) .
CONCLUSIONS	A 6-month supplementation with omega 3 & 6 and antioxidants acts efficiently against hair loss in improving hair density and reducing the telogen percentage and the proportion of miniaturized anagen hair .
CONCLUSIONS	Objectively measured improvements were confirmed by the subjects ' perception of efficacy .

###24625704
BACKGROUND	Sham-controlled low-frequency repetitive transcranial magnetic stimulation ( rTMS ) was used in patients with pharmacoresistant major depression as an added treatment along with partial sleep deprivation ( PSD ) .
BACKGROUND	In addition , the potential predictive role of brain-derived neurotrophic factor genetic polymorphism on treatment response was analyzed .
METHODS	We recruited 19 female patients ( 48.3 8.6 years old ) with treatment-resistant unipolar major depression ( Hamilton Depression Rating Scale [ HDRS ] score 20 ) who were on a stable antidepressant treatment .
METHODS	They received either 1-Hz rTMS or sham stimulation over the right dorsolateral prefrontal cortex ( intensity of 110 % of the threshold ; 3000 stimuli per protocol ; and 10 daily sessions ) .
METHODS	Additionally , PSD was applied once per week during the treatment .
METHODS	The patients were evaluated ( HDRS and Clinical Global Impression Scale ) by a blind rater at baseline ( B ) and after 2 and 3 weeks ( W2 and W3 ) of treatment for short-term outcome .
METHODS	Long-term evaluations were performed after 12 ( W12 ) and 24 weeks ( W24 ) for patients who received active stimulation .
RESULTS	Eleven patients in the active group showed a significant HDRS score reduction from 30.09 3.53 ( B ) to 16.73 5.71 ( W3 ) compared to the lack of therapeutic response in the sham-treated patients .
RESULTS	The long-term follow-up for the active group included 64 % of the responders at W12 and 55 % at W24 .
RESULTS	Full remission ( HDRS 10 ) was achieved in 5 of 11 patients .
RESULTS	Four of these 5 patients with long-term sustained remission expressed the Val66Val genotype .
CONCLUSIONS	Our study suggests a clinically relevant response , persisting for up to 6 months , from 1-Hz rTMS over the right dorsolateral prefrontal cortex and PSD in patients with pharmacoresistant major depression .
CONCLUSIONS	The brain-derived neurotrophic factor Val66Val homozygous genotype may be related to a better treatment outcome .

###24716651
BACKGROUND	Computer-assisted surgery plays an increasingly important role in mandibular reconstruction , ensuring the best possible masticatory function and aesthetic outcome .
METHODS	Twenty patients were randomly assigned to computer-assisted or conventional mandibular reconstruction with vascularized iliac crest bone graft in a prospective study design.Virtual surgical planning was based on preoperative CT-data using specific surgical planning software .
METHODS	A rapid prototyping guide transferred the virtual surgery plan to the operation site .
METHODS	During surgery the transplant ischemic time , reconstruction time , time for shaping the transplant and amount of bone removed were measured .
METHODS	Additionally , the difference in the intercondylar distance before and after surgery was calculated .
RESULTS	Computer-assisted surgery shortened the time of transplant ischemia ( P < 0.005 ) and defect reconstruction ( P < 0.001 ) compared to conventional surgery .
RESULTS	The time to saw and shape the transplant at the donor site was shorter using conventional surgery ( P < 0.005 ) ; therefore , the overall time for surgery did n't change ( P = 0.527 ) .
RESULTS	In the computer-assisted group , the amount of bone harvested equaled the defect size , whereas the transplant size in the conventional group exceeded the defect site by 16.85.6 mm ( P < 0.001 ) on average .
RESULTS	The intercondylar distance before compared to after surgery was less affected in the computer-assisted than in the conventional group ( P < 0.001 ) .
CONCLUSIONS	The presented study shows that computer-assisted surgery can help reduce the time for mandibular defect reconstruction and consequently the transplant ischemic time .
CONCLUSIONS	In the computer-assisted group , the iliac crest donor site defect was downsized and the postoperative condyle position was less altered , reducing possible risks of postoperative complications and donor site morbidity .
BACKGROUND	DRKS00005181 .

###25248797
BACKGROUND	The objectives of this study were to assess the efficacy of lifestyle intervention on gestational weight gain in pregnant women with normal and above normal body mass index ( BMI ) in a randomized controlled trial .
METHODS	A total of 116 pregnant women ( < 20 weeks of pregnancy ) without diabetes were enrolled and 113 pregnant women completed the program .
METHODS	Participants were randomized into intervention and control groups .
METHODS	Women in the intervention group received weekly trainer-led group exercise sessions , instructed home exercise for 3-5-times / week during 20-36 weeks of gestation , and dietary counseling twice during pregnancy .
METHODS	Participants in the control group did not receive the intervention .
METHODS	All participants completed a physical activity questionnaire and a 3-day food record at enrolment and 2 months after enrolment .
RESULTS	The participants in the intervention group with normal pre-pregnancy BMI ( 24.9 kg/M2 , n = 30 ) had lower gestational weight gain ( GWG ) , offspring birth weight and excessive gestational weight gain ( EGWG ) on pregnancy weight gain compared to the control group ( n = 27 , p < 0.05 ) .
RESULTS	Those weight related-changes were not detected between the intervention ( n = 27 ) and control group ( n = 29 ) in the above normal pre-pregnancy BMI participants .
RESULTS	Intervention reduced total calorie , total fat , saturated fat and cholesterol intake were detected in women with normal or above normal pre-pregnancy BMI compared to the control group ( p < 0.05 or 0.01 ) .
RESULTS	Increased physical activity and reduced carbohydrate intake were detected in women with normal ( p < 0.05 ) , but not above normal , pre-pregnancy BMI at 2 months after the onset of the intervention compared to the control group .
CONCLUSIONS	The results of the present study demonstrated that the lifestyle intervention program decreased EGWG , GWG , offspring birth weight in pregnant women with normal , but not above normal , pre-pregnancy BMI , which was associated with increased physical activity and decreased carbohydrate intake .
BACKGROUND	NCT00486629 .

###25223583
BACKGROUND	CPX-351 is a liposome-encapsulated fixed-molar-ratio formulation of cytarabine and daunorubicin that exploits molar ratio-dependent drug-drug synergy to enhance antileukemic efficacy .
METHODS	This phase II study randomized 125 patients 2:1 to CPX-351 or investigators ' choice of first salvage chemotherapy .
METHODS	Patients with acute myeloid leukemia ( AML ) in first relapse after initial Complete Remission ( CR ) lasting 1 month were stratified per the European Prognostic Index ( EPI ) into favorable , intermediate , and poor-risk groups based on duration of first CR , cytogenetics , age , and transplant history .
METHODS	Control salvage treatment was usually based on cytarabine and anthracycline , often with 1 or more additional agents .
METHODS	Survival at 1 year was the primary efficacy end point .
RESULTS	Patient characteristics were well balanced between the 2 study arms .
RESULTS	Improvements in efficacy outcomes were observed following CPX-351 , but did not meet prospectively defined statistical criteria for 1-year survival improvement in the overall population .
RESULTS	Subset analyses of the EPI-defined poor-risk strata demonstrated higher response rates ( 39.3 % vs 27.6 % ) and improvements in event-free survival ( HR , 0.63 ; P = .08 ) and overall survival ( HR , 0.55 ; P = .02 ) .
RESULTS	Also , 60-day mortality was lower in the CPX-351 study arm for poor-risk patients ( 16.1 % vs 24.1 % ) .
CONCLUSIONS	Taken together , the data suggest possible improved outcomes in CPX-351-treated first relapse AML patients with EPI-defined poor-risk disease .

###24906295
OBJECTIVE	to compare the effects of pulsed electromagnetic field ( PEMF ) therapy and sham treatment on DOMS-related variables in elbow flexors at 24 , 48 and 72 h after delayed onset muscle soreness ( DOMS ) induction exercise .
METHODS	randomized , double-blind , placebo-controlled study .
METHODS	Yonsei University laboratory .
METHODS	In total , 30 healthy male college students .
METHODS	Muscle soreness , peak torque , median frequency ( MDF ) and electromechanical delay ( EMD ) during isometric contraction at 24 , 48 and 72 h after DOMS induction exercise .
RESULTS	Overall , the application of the PEMF was found to be effective in reducing the physiological deficits associated with DOMS , including improved recovery of perceived muscle soreness , MDF , and EMD during isometric contraction .
RESULTS	Our results did not show that PEMF treatment was mechanically more effective for isometric peak torque generation compared to the sham group .
CONCLUSIONS	this study indicates that PEMF may be useful as a modality to reduce DOMS symptoms .
CONCLUSIONS	However , further well-designed experiments are required to determine optimal treatment dosage and duration , and to investigate the physiological and clinical mechanisms of PEMF on DOMS .

###24445084
OBJECTIVE	Supervised exercise training ( SET ) is recommended for patients with intermittent claudication ( IC ) .
OBJECTIVE	The optimal exercise programme has not been identified , and the potential adverse effects of exercise on these patients warrant consideration .
OBJECTIVE	Calpain proteases have been linked with tissue atrophy following ischaemia-reperfusion injury .
OBJECTIVE	High calpain activity may therefore cause muscle wasting in claudicants undergoing SET , and skeletal muscle mass ( SMM ) is integral to healthy ageing .
OBJECTIVE	This study assesses the impact of ( 1 ) treadmill-based SET alone ; and ( 2 ) treadmill-based SET combined with resistance training on pain-free walking distance ( PFWD ) , SMM , and calpain activity .
METHODS	Thirty-five patients with IC were randomised to 12 weeks of treadmill only SET ( group A ) , or combined treadmill and lower-limb resistance SET ( group B ) .
METHODS	PFWD via a 6-minute walking test , SMM via dual energy X-ray absorptiometry , and calpain activity via biopsies of gastrocnemius muscles were analysed .
RESULTS	Intention-to-treat analyses revealed PFWD improved within group A ( 160 m to 204 m , p = .03 ) , but not group B ( 181 m to 188 m , p = .82 ) .
RESULTS	There was no between group difference ( p = .42 ) .
RESULTS	Calpain activity increased within group A ( 1.62 10 ( 5 ) fluorescent units [ FU ] to 2.21 10 ( 5 ) FU , p = .05 ) , but not group B.
RESULTS	There was no between group difference ( p = .09 ) .
RESULTS	SMM decreased within group A ( -250 g , p = .11 ) and increased in group B ( 210 g , p = .38 ) ( p = .10 between groups ) .
RESULTS	Similar trends were evident for per protocol analyses , but , additionally , change in SMM was significantly different between groups ( p = .04 ) .
CONCLUSIONS	Neither exercise regimen was superior in terms of walking performance .
CONCLUSIONS	Further work is required to investigate the impact of the calpain system on SMM in claudicants undertaking SET .

###25509255
OBJECTIVE	To observe the therapeutic effect and relevant mechanism of shuxuening Injection ( SI ) in treating patients with active ulcerative colitis ( UC ) .
METHODS	Totally 91 patients with active UC were randomly assigned to 2 groups , 44 in the control group and 47 in the treatment group .
METHODS	Patients in the control group received routine treatment , while patients in the treatment group additionally received intravenous injection of SI ( 15 mL ) , twice daily for 14 days in total .
METHODS	Colonoscopy was performed before and after treatment .
METHODS	The therapeutic effect was assessed by Mayo scoring system and the grading of activities evaluated by Baron endoscope .
METHODS	Serum levels of IL-6 and TNF - were detected by ELISA .
METHODS	The activity of SOD was detected by xanthine oxidase method .
METHODS	The content of MDA was detected by thiobarbituricacid ( TBA ) .
METHODS	Besides , 20 healthy subjects were recruited as the healthy control group .
RESULTS	Totally 82 patients completed the study ( 40 in the control group and 42 in the treatment group ) .
RESULTS	There was no statistical difference in serum levels of IL-6 , TNF - , SOD , MDA , the Mayo score and endoscope grading between the two groups before treatment ( P > 0.05 ) .
RESULTS	Compared with the healthy control group , serum levels of IL-6 , TNF - , MDA significantly increased ( P < 0.01 ) , and the serum SOD level decreased ( P < 0.05 ) in the treatment grup and the control group before treatment .
RESULTS	Compared with before treatment in the same group , serum levels of IL-6 , TNF - , MDA , the Mayo score and endoscope grading all decreased in the treatment group and the control group after treatment ( P < 0.01 , P < 0.05 ) .
RESULTS	Compared with the control group after treatment , serum levels of IL-6 , TNF - , MDA , the Mayo score and endoscope grading all decreased ( P < 0.01 , P < 0.05 ) , the serum SOD level increased ( P < 0.05 ) in the treatment group after treatment .
RESULTS	The serum SOD level was obviously negative correlated with serum levels of IL-6 , TNF-a , Mayo score , and endoscope score ( r = -0.621 , -0.638 , -0.509 , -0.787 , P < 0.01 ) .
RESULTS	The serum MDA level was obviously positive correlated with serum levels of IL-6 , TNF - , Mayo score , and endoscope score ( r = 0.711 , 0.882 , 0.525 , 0.639 , P < 0.01 ) .
CONCLUSIONS	SI could improve inflammatory injury and clinical symptoms of patients with active UC , and its mechanism might be associated with antioxidant and scavenging oxygen free radicals .

###25169631
OBJECTIVE	To explored the effect of sildenafil in treatment of pregnant women with pulmonary arterial hypertension .
METHODS	From January 2012 to November 2013 , 64 pregnant women with pulmonary arterial hypertension ( PAH ) were randomly divided into group and control group .
METHODS	16 cases with mild and 16 cases with moderate PAH .
METHODS	To treatment with low-flow oxygen , low-salt diet therapy , cardiac , etc.sildenafil group : 15 cases were mild pulmonary hypertension , and 17 cases moderate PAH .
METHODS	Treatment sildenafil 25 mg , tid in this study .
METHODS	Then the variation of the blood oxygen saturation , pulmonary artery systolic pressure , hemodynamic parameters and pregnancy outcome , including delivery modes , neonatal weight , morbidity of mother and fetus were compared .
RESULTS	( 1 ) Cardiac function and pulmonary hypertension : control group : the proportion of cardiac functional class I-II reduced from 81 % ( 26/32 ) to 56 % ( 18/32 ) significantly after treatment ( P < 0.05 ) .
RESULTS	Sildenafil group : the proportion of cardiac functional class I-II increased from 75 % ( 24/32 ) to 84 % ( 27/32 ) significantly after treatment ( P < 0.05 ) .
RESULTS	Between two groups , the proportion of mild and moderate turning to server PAH patients were significant difference ( P < 0.05 ) .
RESULTS	( 2 ) The pregnancy outcome of two group : the premature birth rate , low birth weight rate and cesarean section rate of 9 % ( 3/32 ) , 9 % ( 3/32 ) and 69 % ( 22/32 ) in sildenafil group were significantly lower than 16 % ( 5/32 ) , 19 % ( 6/32 ) and 81 % ( 26/32 ) in control group ( P < 0.05 ) .
RESULTS	The rate of vaginal delivery , term pregnancy and neonatal weight of 31 % ( 10/32 ) , 91 % ( 29/32 ) and ( 3 214 306 ) g in sildenafil group were different with 19 % ( 6/32 ) , 84 % ( 27/32 ) and ( 3 004 458 ) g in control group ( P < 0.05 ) .
RESULTS	( 3 ) Hemodynamic parameters : in control group , arterial partial pressure of oxygen , oxygen saturation and left ventricular ejection fraction , pulmonary systolic pression were ( 80 5 ) % to ( 72 8 ) % , ( 87 8 ) to ( 83 9 ) mmHg ( 1 mmHg = 0.133 kPa ) , 0.77 0.24 to 0.70 0.38 and ( 63 9 ) to ( 69 12 ) mmHg before and after treatment , which showed remarkable decreased trends ( P < 0.05 ) .
RESULTS	The other parameter were not significantly different ( P > 0.05 ) .
RESULTS	In sildenafil group , arterial partial pressure of oxygen , oxygen saturation and left ventricular ejection fraction , pulmonary systolic pression showed increased trend before and after treatment , which were ( 80 9 ) % to ( 88 9 ) % , ( 84 3 ) to ( 89 7 ) mmHg , 0.70 0.32 to 0.79 0.27 ( P < 0.05 ) , in the mean time , pulmonary systolic pression showed decreased trend from ( 65 18 ) to ( 60 13 ) mmHg ( P < 0.05 ) .
RESULTS	The other parameter did not show significant different ( P > 0.05 ) .
CONCLUSIONS	Sildenafil treatment can significantly improve the clinical symptoms , cardiac function and hemodynamic parameters.It also could significantly improve pregnancy outcomes , reduce premature delivery , the incidence of low birth weight children , and cesarean section rate .

###24867903
BACKGROUND	The effectiveness of exercise therapy in the treatment of osteoarthritis of the knee ( KOA ) is widely evidenced .
BACKGROUND	The current study aims to compare the effectiveness of massage therapy as a co-adjuvant treatment for KOA .
METHODS	A blind , randomized controlled trial design was used .
METHODS	Eighteen women were randomly allocated to two different groups .
METHODS	Group A was treated with massage therapy and an exercise program , and Group B was treated with the exercise program alone .
METHODS	The intervention lasted for 6 weeks .
METHODS	Outcomes were assessed using a verbal analogue scale ( VAS ) , the WOMAC index , and the Get-Up and Go test .
METHODS	Baseline , post-treatment , and 1 - and 3 - month follow-up data were collected .
METHODS	Values were considered statistically significant at a p < 0.05 .
METHODS	The Mann-Whitney U test was applied in order to find out the differences between groups , and to verify the existence of such differences , the Friedman Test for repeated measures complemented with multiple comparisons tests was carried out .
RESULTS	In both groups , significant differences were found in the three variables between the baseline measurement and three months after treatment , with the exception of the WOMAC variable in group B ( p = 0.064 ) No significant differences were found between both groups in the WOMAC index ( p = 0.508 ) and VAS ( p = 0.964 ) variables and the Get-Up and Go test ( p = 0.691 ) .
CONCLUSIONS	Combining exercise-based therapy with massage therapy may lead to clinical improvement in patients with KOA .
CONCLUSIONS	The use of massage therapy combined with exercise as a treatment for gonarthrosis does not seem to have any beneficial effects .

###25854013
OBJECTIVE	To explore the best therapy for infertility caused by polycystic ovary syndrome ( PCOS ) .
METHODS	One hundred and twenty patients were randomized into three groups , a clomi-phene group ( group A ) , an acupuncture-moxibustion + Chinese medicine group ( group B ) and a clomiphene + acupuncture-moxibustion + Chinese medicine group ( group C ) , 40 cases in each one .
METHODS	In the group A , since the 5th day of menstruation , clomiphene was prescribed for oral administration .
METHODS	In the group B , on the 5th day of menstruation , warm needling therapy was applied at Zhongji ( CV 3 ) , Guanyuan ( CV 4 ) , Guilai ( ST 29 ) , etc. .
METHODS	Additionally , the Chinese herbal medication for tonifying the kidney and activating blood circulation was provided .
METHODS	In the group C , the therapy as the group B was combined on the basis of the treatment as the group A.
METHODS	The treatment lasted continuously for 3 menstrual cycles .
METHODS	The endometrial thickness , endometrial type and cervical mucus score on human chorionic gon adotropin ( HCG ) day , and ovulatory cycle rate , clinical pregnancy rate and abortion rate after treatment were observed in the patients of the three groups .
RESULTS	1 ) HCG day cervical mucus score , endometrial thickness and endometrial morphology ( A type rate ) : the results in the group C were better than those in the group A ( all P < 0.01 ) ; the results in the group B were better than those in the group A ( all P < 0.05 ) .
RESULTS	The difference in the endometrial thickness was not significant in comparison between the group C and the group B ( P > 0.05 ) .
RESULTS	The cervical mucus score and endometrial morphology ( A type rate ) in the group C were better than those in the group B ( both P < 0.05 ) .
RESULTS	2 ) The ovulatory cycle rates in the group A and group ( C were higher than that in the group B ( both P < 0.05 ) , the pregnancy rate in the group C was higher than that in the other groups ( both P < 0.05 ) , and the early abortion rate in the group C was lower than that in the group A and group B ( both P < 0.01 ) .
RESULTS	3 ) Follicle diameter from 18 mm to 20 mm and endometrial thickness : the differences were not significant between the normal pregnancy patients and the early abortion patients ( both P > 0.05 ) .
RESULTS	The endometrial morphology A type rate in the normal pregnancy patients was higher than that in the early abortion patients ( P < 0.05 ) .
CONCLUSIONS	The combined therapy of acupuncture , herbal medicine and clomiphene improves the pregnancy rate and reduces early abortion rate by effectively improving HCG day cervical mucus , endometrial thickness and morphology .
CONCLUSIONS	The efficacy is apparently superior to the simple medication with clomiphene and the combined application of acupuncture and herbal medicine .

###24421054
BACKGROUND	To reduce the seroma formation following mastectomy and axillary dissection , many different techniques and drugs have been investigated .
BACKGROUND	The aim of this study is to evaluate the effects of oral - glucan on drain fluid and efficacy of daily drainage and drain removal day in mastectomy patients .
METHODS	One hundred and thirty breast cancer patients of Ankara Oncology Training and Research Hospital were divided into 2 groups by consecutive randomization ( n = 65 each ) .
METHODS	- glucan 10mg capsules were administered to Group 1 twice a day for 10days .
METHODS	Group 2 took placebos in the same manner .
METHODS	Age , menarche age , menopause , parity , history of oral contraceptives , comorbidities , postoperative daily drainage volumes and drain removal days were recorded and compared .
METHODS	Seroma samples during the first and second day of drainage were taken for analysis of Interleukin-6 ( IL-6 ) and Tumor Necrosis Factor ( TNF - ) .
RESULTS	There was no difference between groups in terms of age , menarche age , menopause period , parity , oral contraceptive use and comorbidities .
RESULTS	Group 1 showed significantly lower daily drainage volumes between days 2 and 8 .
RESULTS	Mean drain removal day was 7.161.72 in Group 1 and 8.592.27 in Group 2 .
RESULTS	The difference was significant ( p < 0.001 ) .
RESULTS	TNF - and IL-6 levels on days 1 and 2 in Group 1 were significantly lower ( p < 0.001 ) .
RESULTS	In addition , - glucan significantly shortened the number of days required for the drain removal in patients who have comorbidities ( p = 0.018 ) .
RESULTS	The earliest removal was in patients without comorbidity and who received - glucan ( p = 0.002 ) .
CONCLUSIONS	- glucan decreased drain discharges after mastectomy .
CONCLUSIONS	The drains were removed earlier in - glucan administered patients .

###25344807
OBJECTIVE	Efavirenz and nevirapine failure is associated with a rapid selection of resistance-associated mutations ( RAMs ) , which may impact on etravirine or rilpivirine susceptibility .
OBJECTIVE	However , RAMs for rilpivirine and etravirine can not be reported on previous resistance genotypes because these specific RAMs were not analyzed at that time .
OBJECTIVE	Therefore , our objective was to determine , in virologically suppressed HIV-1-infected individuals , the presence of RAMs to rilpivirine , etravirine and the combination of tenofovir/emtricitabine/rilpivirine in HIV-1 DNA from individuals previously exposed to efavirenz and/or nevirapine .
METHODS	The studied population included 169 treatment-experienced individuals enrolled in the ANRS 138-EASIER trial who previously failed on and/or were intolerant to efavirenz and/or nevirapine and who had plasma HIV-1 RNA < 400 copies/mL .
METHODS	Resistance to rilpivirine , etravirine , tenofovir and emtricitabine by bulk sequencing was performed on extracted HIV-1 DNA from whole blood collected at the time of trial inclusion .
RESULTS	Reverse transcriptase gene amplification was successful in 128/169 ( 76 % ) individuals and 95 % of HIV-1 were infected with subtype B. Rilpivirine RAMs were detected in 41 ( 32 % ) individuals , with highest frequency for the mutations Y181C/I/V ( 18 % ) , K101E/P ( 7 % ) and E138A/G/K / Q/R/S ( 6 % ) and the association L100I + K103N/S ( 5 % ) .
RESULTS	Etravirine RAMs were detected in five ( 4 % ) individuals .
RESULTS	Resistance to emtricitabine , tenofovir and at least one drug included in the combination of tenofovir/emtricitabine/rilpivirine were detected in 72 ( 56 % ) , 12 ( 9 % ) and 88 ( 69 % ) , respectively .
CONCLUSIONS	In individuals with suppressed viraemia under antiretroviral therapy ( ART ) , but who had been previously exposed to an efavirenz and/or nevirapine-based regimen , rilpivirine RAMs are frequent and etravirine RAMs are rare .
CONCLUSIONS	This finding suggests that the switch to a rilpivirine-based regimen should not be recommended .

###25533223
OBJECTIVE	To evaluate the incremental prognostic value of the number and maximum volume of coronary artery calcifications over modified Agatston score strata , age , pack-years , and smoking status for predicting cardiovascular events .
METHODS	A total of 3559 male current and former smokers received a CT examination for lung cancer screening .
METHODS	Smoking characteristics , patient demographics , and physician-diagnosed cardiovascular events were collected .
METHODS	Images were acquired without electrocardiography gating on 16-slice CT scanners .
METHODS	The association between the presence of both fatal and nonfatal cardiovascular events and the predictors was quantified using Cox proportional hazard analysis .
RESULTS	Median follow-up period was 2.9 years .
RESULTS	Incident cardiovascular events occurred in 186 participants .
RESULTS	Adjusted hazard ratios for modified Agatston score strata of 1 to 10 , 11 to 100 , 101 to 400 , and > 400 were 3.39 ( 95 % confidence interval [ CI ] , 1.20-9 .59 ) , 6.52 ( 95 % CI , 2.73-15 .60 ) , 6.58 ( 95 % CI , 2.75-15 .78 ) , and 12.58 ( 95 % CI , 5.42-29 .16 ) , respectively .
RESULTS	Moreover , comparing the models with and without modified Agatston score strata to the model with age , pack-years , and smoking status yielded a significantly better net reclassification improvement ( NRI ; 27.3 % ; P < .0001 ) .
RESULTS	Adding the number of calcifications to the model with age , pack-years , smoking status , and modified Agatston score strata resulted in a slightly better NRI ( 1.68 % ; P = .0490 ) with a hazard ratio of 1.13 ( 95 % CI , 1.05-1 .21 ) per 10 calcifications .
RESULTS	The incremental prognostic information contained in the volume of the largest calcification was not statistically significant ( NRI , 0.14 % ; P = .3458 ) .
CONCLUSIONS	Cardiovascular event rate increased with higher numbers of calcified lesions .
CONCLUSIONS	The number but not maximum volume of calcifications has independent , although minimal , prognostic value over age , pack-years , smoking status , and modified Agatston score strata in our population .

###25453458
BACKGROUND	The results of the CLOTS 3 trial showed that intermittent pneumatic compression ( IPC ) reduced the risk of deep vein thrombosis and improved survival in immobile patients with stroke .
BACKGROUND	IPC is now being widely used in stroke units .
BACKGROUND	Here we describe the disability , living circumstances , quality of life , and hospital costs of patients in CLOTS 3 .
METHODS	In CLOTS 3 , a parallel group trial in 94 UK hospitals , immobile patients with stroke from days 0 to 3 of admission were assigned with a computer-generated allocation sequence in a 1:1 ratio to IPC or no IPC through a central randomisation system .
METHODS	We followed up patients at about 6 months with postal or telephone questionnaire to assess the secondary endpoints : disability ( Oxford Handicap Scale [ OHS ] ) , living circumstances , health-related quality of life ( EQ5D-3L ) , and hospital costs ( based on use of IPC and length of hospital stay ) .
METHODS	Patients and carers who completed the postal questionnaires were not masked to treatment allocation , but telephone follow-up in non-responders was masked .
METHODS	All analyses were by intention to treat .
METHODS	This trial is registered , number ISRCTN93529999 .
RESULTS	Between Dec 8 , 2008 , and Sept 6 , 2012 , we enrolled 2876 patients , with 1438 in each group .
RESULTS	Despite the previously reported reduction in the risk of proximal deep vein thrombosis at 30 days ( primary endpoint ) , there were no significant differences in disability ( OHS 0-2 vs 3-6 , adjusted odds ratio [ OR ] 098 , 95 % CI 080 to 119 , p = 083 ; adjusted ordinal analysis common OR 097 , 95 % CI 086 to 111 ) , living circumstances ( institutional care vs not ; adjusted OR 111 , 95 % CI 089 to 137 ; p = 0358 ) , or health-related quality of life ( median utility value 026 , IQR -007 to 066 with IPC , and 027 , -006 to 064 , with no IPC ; p = 0952 ) .
RESULTS	The estimated cost of IPC was 6410 per patient ( SD 283 ) .
RESULTS	The direct costs of preventing a deep vein thrombosis and death were 1282 ( 95 % CI 785 to 3077 ) and 2756 ( 1346 to not estimable ) , respectively , with IPC .
RESULTS	Hospital costs increased by 451 with IPC compared with no IPC because of a longer stay in hospital ( mean 445 days [ SD 376 ] vs 428 days [ 372 ] ; mean difference 18 days , 95 % CI -10 to 45 ) .
RESULTS	By 6 months , despite an increase in survival ( IPC 1525 days [ SD 606 ] vs no IPC 1481 days [ 643 ] ; mean difference 45 days , 95 % CI -02 to 91 ) , there was a non-significant increase in quality-adjusted survival associated with IPC ( IPC 276 days [ SD 406 ] vs no IPC 267 days [ 396 ] ; mean difference 09 days , 95 % CI -21 to 39 ) .
CONCLUSIONS	IPC is inexpensive , prevents deep vein thrombosis , improves survival but not functional outcomes , and does not lead to a significant gain in quality-adjusted survival .
CONCLUSIONS	When deciding whether to treat patients with IPC , clinicians need to take into account all these potential effects .
BACKGROUND	National Institute of Health Research Health Technology Assessment Programme , Chief Scientist Office of Scottish Government , and Covidien .

###24248149
OBJECTIVE	Psychogenic gait disorder , defined as loss of ability to walk without neurological aetiologies , has poor rehabilitation options that are well documented .
OBJECTIVE	Left untreated these patients have substantial and long-lasting dysfunction .
OBJECTIVE	The present study examined the effect of a 3-week inpatient rehabilitation programme compared with a waiting list control condition , and whether eventual gains were maintained at 1-month and 1-year follow-up .
METHODS	A cross-over design evaluated the effect of treatment , and a carry-over effect was considered as a long-lasting treatment effect .
METHODS	Treatment consisted of adapted physical activity within a cognitive behavioural framework , and focused on offering an alternative explanation of symptoms , positively reinforcing normal gait and not reinforcing dysfunction .
METHODS	A total of 60 patients were recruited from neurological departments and were randomly assigned to immediate treatment ( intervention ) or treatment after 4 weeks ( controls ) .
RESULTS	Cross-over design revealed that the mean difference between treatment vs no treatment was 8.4 Functional Independence Measure units ( p < 0.001 , 95 % confidence interval 5.2-11 .7 ) , and 6.9 Functional Mobility Scale units ( p < 0.001 , 95 % confidence interval 5.5-8 .3 ) .
RESULTS	Patients significantly improved their ability to walk and their quality of life after inpatient rehabilitation compared with the untreated control group .
RESULTS	The improvements in gait were sustained at 1-month and 1-year follow-up .
CONCLUSIONS	Substantial and lasting improvement can be achieved by inpatient rehabilitation of patients with psychogenic gait , and the gains are maintained during follow-up .

###25049068
BACKGROUND	Chronic lung allograft dysfunction ( CLAD ) , predominantly manifest as bronchiolitis obliterans syndrome ( BOS ) , is the primary cause of morbidity and death after lung transplantation .
BACKGROUND	We assessed the efficacy and safety of 2 de novo immunosuppression protocols to prevent BOS .
METHODS	This was a multicenter , prospective , international , randomized ( 1:1 ) open-label superiority study of de novo enteric-coated mycophenolate sodium ( MPS ) vs delayed-onset everolimus ( RAD ) , both arms in combination with cyclosporine ( CsA ) monitored by 2-hour post-dose ( C2 ) levels , and corticosteroids .
METHODS	Target C2 levels were lower in the RAD group because RAD is known to potentiate CsA nephrotoxicity .
METHODS	Cytolytic induction therapy was not used .
METHODS	Patients were stratified at entry for cystic fibrosis .
METHODS	Confirmation of anastomotic healing was required for randomization .
METHODS	Primary efficacy was freedom from BOS Grade 1 on intention-to-treat ( ITT ) analysis .
METHODS	Secondary efficacy parameters were patient and graft survival and severity of rejection .
METHODS	Treatment failure was defined by graft loss , patient death , drug cessation , or need for other therapy .
RESULTS	The 3-year freedom from BOS Grade 1 was 70 % for MPS ( n = 80 ) vs 71 % for RAD ( n = 84 ; p = 0.95 by log-rank ) in ITT but was lower in the RAD arm of the per-protocol population ( p = 0.03 ) .
RESULTS	The 3-year survival was 84 % ( MPS ) vs 76 % ( RAD ; p = 0.19 by log-rank ) .
RESULTS	Thirteen patients switched from MPS vs 31 from RAD ( p < 0.01 ) .
RESULTS	Days on MPS were greater than days on RAD ( p < 0.01 ) .
RESULTS	Rejection events proven by biopsy specimen were more common on MPS ( p = 0.02 ) , as were leucopenia ( p < 0.01 ) , diarrhea ( p < 0.01 ) , and cytomegalovirus infection ( p = 0.04 ) .
RESULTS	Venous thromboembolism was more frequent on RAD ( p = 0.02 ) .
RESULTS	Creatinine at 3 years was 160 112 mol/1iter in MPS patients vs 152 98 mol/1iter in RAD patients ( p = 0.67 ) .
CONCLUSIONS	This 3-year ITT analysis found no significant difference between arms but was underpowered to accept the null hypothesis that RAD and MPS have equivalent efficacy in preventing BOS or death after lung transplantation .

###24957753
OBJECTIVE	We tested the hypothesis that sleep training would improve emotional , social and behavioural functioning in children with attention-deficit/hyperactivity disorder ( ADHD ) compared to children with ADHD without such intervention and to healthy controls .
METHODS	Forty children with ADHD were randomly assigned to intervention and control conditions .
METHODS	Parents of 20 children with ADHD were instructed and thoroughly supervised in improving their children 's sleep schedules and sleep behaviour .
METHODS	Parents of the other 20 children with ADHD and parents of 20 healthy children received general information about sleep hygiene .
METHODS	At baseline and 12 weeks later , parents and children completed questionnaires related to children 's sleep and psychological functioning .
RESULTS	Relative to the control groups , children in the intervention group improved sleep quantitatively and qualitatively ( F values < 3.33 , P values < 0.05 ) .
RESULTS	The intervention group children reported improvements in mood , emotions , and relationships ( F values < 2.99 , P values < 0.05 ) .
RESULTS	Parents reported that their children improved in physical and psychological wellbeing , mood , emotions , relationships , and social acceptance ( F values < 3.02 , P values < 0.05 ) .
CONCLUSIONS	Training and monitoring parents of children with ADHD in regulating and supervising children 's sleep schedules leads to positive changes in the emotions , behaviour and social lives of these children .

###24376842
OBJECTIVE	To compare the impact of scheduling caesarean section prior to versus after 39 completed weeks of gestation on the occurrence of unscheduled caesarean section and rescheduling of the procedure .
METHODS	Secondary analysis from a multicentre randomised open-label trial including singleton pregnant women with a healthy foetus and a reliable due date .
METHODS	Women were allocated by computerized telephone randomisation to planned caesarean section at 38 weeks and three days or 39 weeks and three days .
METHODS	The outcomes were unscheduled deliveries with provided reasons , such as spontaneous labour onset or supervening complications , and any changes in the scheduled delivery date .
METHODS	Statistical analyses were according to intention-to-treat using Fisher 's exact test .
RESULTS	From March 2009 to June 2011 1,274 women were included .
RESULTS	Median difference in gestational age at delivery was six days .
RESULTS	Compared to the 38 weeks group , the women in the 39 weeks group were more likely to have an unscheduled caesarean section ( 15.2 % vs. 9.3 % ; RR 1.64 , 95 % CI 1.21 ; 2.22 ) , to deliver between 6 pm and 8 am ( 10 % vs. 6 % ; RR 1.68 , 95 % CI 1.14 ; 2.47 ) , or to have the procedure rescheduled ( 36.7 % vs. 23 % ; RR 1.6 , 95 % CI 1.34 ; 1.90 ) .
CONCLUSIONS	Scheduling caesarean section after 39 weeks leads to a 60 % increase in unscheduled caesarean sections and a 70 % increase in delivery outside regular work hours as compared to scheduling of the procedure prior to 39 weeks .
BACKGROUND	www.clinicaltrials.gov NCT00835003 http://www.clinicaltrials.gov/ct2/show/NCT00835003?term=NCT00835003&rank=1 .

###24741361
OBJECTIVE	We hypothesized that 4 days of normal daily activity after 21 days of experimental bed rest ( BR ) will not reverse BR induced impaired glucose tolerance .
METHODS	Glucose tolerance of seven male , healthy , untrained test subjects ( age : 27.6 ( 3.3 ) years ( mean ( SD ) ) ; body mass : 78.6 ( 6.4 ) kg ; height : 1.81 ( 0.04 ) m ; VO2 max : 39.5 ( 5.4 ) ml/kg body mass/min ) was studied .
METHODS	They stayed twice in the metabolic ward ( crossover design ) , 21 days in bed and 7 days before and after BR each .
METHODS	Oral glucose tolerance tests were applied before , on day 21 of BR , and 5 and 14 days after BR .
RESULTS	On day 21 of BR , AUC ( 120min ) of glucose concentration was increased by 28.8 ( 5.2 ) % and AUC ( 120min ) of insulin by 35.9 ( 10.2 ) % ( glucose : P < 0.001 ; insulin : P = 0.02 ) .
RESULTS	Fourteen days after BR , AUC ( 120min ) of serum insulin concentrations returned to pre-bed-rest concentrations ( P = 0.352 ) and AUC ( 120min ) of glucose was still higher ( P = 0.038 ) .
RESULTS	Insulin resistance did not change , but sensitivity index was reduced during BR ( P = 0.005 ) .
CONCLUSIONS	Four days of light physical workload does not compensate inactivity induced impaired glucose tolerance .
CONCLUSIONS	An individually tailored and intensified training regime is mandatory in patients being in bed rest to get back to normal glucose metabolism in a reasonable time frame .

###24323062
OBJECTIVE	The purpose of this study was to investigate whether gentamicin irrigation solutions provide a potential new tool to prevent joint infection after arthroscopic ACL reconstruction .
METHODS	In this prospective randomized study , 360 consecutive ACL recondition patients were randomized in two groups alternately from Feb 2008 to March 2012 .
METHODS	In the first group , 180 patients underwent ACL reconstruction with a hamstring autograft , preoperative IV antibiotics , and normal saline ( 0.9 % sodium chloride ) solution .
METHODS	In the second group 180 patients underwent ACL reconstruction with a hamstring autograft , preoperative IV antibiotics , and normal saline ( 0.9 % sodium chloride solution ) with added gentamicin ( 80 mg/L ) ( group 2 ) .
METHODS	Three patients from group 1 and six patients from group 2 were excluded from the study due to loss of follow-up .
METHODS	The patients were followed for 6 months and assessed for signs of deep infection .
RESULTS	In group 1 , a total of 4 ( 2.2 % ) postoperative septic arthritis cases were documented .
RESULTS	In group 2 , just one postoperative deep infection ( septic arthritis ) was documented ( 0.57 % ) .
RESULTS	Although the rate of septic arthritis in group 1 was higher than in group 2 , statistical analysis showed that the difference between using the gentamicin irrigation solution ( 80 mg/L ) and the saline solution alone was not significant .
CONCLUSIONS	Using gentamicin in irrigating solutions during arthroscopic ACL reconstruction surgery does not statistically decrease post operation septic arthritis .
METHODS	Therapeutic Level II .

###25306750
OBJECTIVE	To evaluate the effect of sitagliptin in combination with metformin on glucose toxicity and lipotoxicity in patients with type 2 diabetes mellitus .
METHODS	Eighty-two overweight and dyslipidemic patients ( mean age 55.3 + / - 9.1 years ) who had not achieved the goal levels of glycated hemoglobin ( HbA1c ) ( mean level 8.3 + / - 1.6 % ) during metformin therapy and dietotherapy were examined .
METHODS	Group 1 patients received sitagliptin 100 mg/day in combination with metformin 2 g/day ; Group 2 took metformin 1.5-2 g/day .
METHODS	The levels of fasting plasma glucose ( FPG ) levels , postprandial glycemia ( PPG ) , HbA1c , body weight , body mass index , waist circumference , and waist-to-hip ratio , blood lipid composition , and the levels of insulin , leptin , adiponectin , HOMA-IR , and HOMA-beta were estimated at baseline and 6 months later .
METHODS	Visceral fat ( VF ) magnetic resonance imaging ( MRI ) was carried out .
RESULTS	Following 6 months , both groups showed positive changes in FPG , PPG , and HbA1c levels .
RESULTS	HbA1c decreased from 8.3 + / - 1.6 to 6.6 + / - 1.24 % in Group 1 and from 8.35 + / - 1.75 to 7.62 + / - 1.39 % in Group 2 .
RESULTS	PPG and FPG reduced by an average of 2.67 and 3.3 mmol/l in Group 1 and by 2.1 and 1.8 mmol/l in Group 2 .
RESULTS	HOMA-beta increased by 23.4 .
RESULTS	conventional units ( CU ) in Group 1 and by 4.8 CU in Group 2 .
RESULTS	HOMA-IR was noted to display positive changes in both groups .
RESULTS	The level of adiponectin rose by 1.9 ng/ml in Group 1 and by 0.49 % ng/ml in Group 2 and that of leptin fell by 7.37 and 1.21 ng/ml , respectively .
RESULTS	There were significant differences between the groups in anthropometric changes .
RESULTS	MRI revealed a significant VF drop by 20.6 + / - 13.5 cm2 ( 7.5 % ) in Group 1 and by 5.7 + / - 3.75 cm2 ( 1.76 % ) in Group 2 .
CONCLUSIONS	Combined therapy with sitagliptin and metformin caused reductions in glucose toxicity and lipotoxicity .

###24649895
BACKGROUND	Genetic counseling for hereditary breast or colon cancer has implications for both counselees and their relatives .
BACKGROUND	Although counselees are encouraged by genetic counselors to disclose genetic cancer risk information , they do not always share this information with their at-risk relatives .
BACKGROUND	Reasons for not informing relatives may be generally categorized as a lack of knowledge , motivation and/or self-efficacy .
BACKGROUND	Presented here is the protocol of a randomized controlled trial that aims to establish the effectiveness of an intervention focused on supporting counselees in their disclosure of genetic cancer information to their relatives .
METHODS	A multicenter randomized controlled trial with parallel group design will be used to compare the effects of an additional telephone counseling session performed by psychosocial workers to enhance the disclosure of genetic cancer information to at-risk relatives ( intervention group ) with a control group of standard care .
METHODS	Consecutive index patients with relatives at risk for hereditary or familial breast and/or ovarian cancer or colon cancer , are randomly assigned ( block size : 8 ; 1:1 allocation ratio ) to the intervention ( n = 132 ) or control group ( n = 132 , standard care ) .
METHODS	Primary outcomes are counselees ' knowledge , motivation and self-efficacy regarding informing their relatives .
CONCLUSIONS	This intervention may prove important in supporting counselees to disclose hereditary and/or familial cancer risk information to at-risk relatives and may enable more at-risk relatives to make a well-informed decision regarding genetic services and/or screening .
BACKGROUND	This trial is registered in the Netherlands National Trial Register ( NTR ) with trial ID number NTR3745 .

###24608200
BACKGROUND	We have previously shown the prognostic importance of tumor-infiltrating lymphocytes ( TILs ) in newly diagnosed triple-negative breast cancer ( TNBC ) using tumor samples from a large clinical trial cohort .
BACKGROUND	In this study , we aimed to validate these findings and also investigate associations with trastuzumab benefit in HER2-overexpressing disease ( HER2 + ) .
METHODS	A prospective-retrospective study was conducted using samples from the FinHER adjuvant , phase III trial that enrolled 1010 early-stage BC patients , 778 of whom were HER2-nonamplified .
METHODS	Those with HER2 + disease ( n = 232 ) were randomized to 9 weeks of trastuzumab or no trastuzumab in addition to chemotherapy .
METHODS	Two pathologists independently quantified stromal TILs in 935 ( 92.6 % ) available slides .
METHODS	The primary end point of distant disease-free survival ( DDFS ) and interactions with trastuzumab were studied in Cox regression models .
RESULTS	Confirming our previous findings , in TNBC ( n = 134 ) each 10 % increase in TILs was significantly associated with decreased distant recurrence in TNBC ; for DDFS the hazard ratio adjusted for clinicopathological factors : 0.77 ; 95 % confidence interval ( CI ) 0.61-0 .98 , P = 0.02 .
RESULTS	In HER2 + BC ( n = 209 ) , each 10 % increase in lymphocytic infiltration was significantly associated with decreased distant recurrence in patients randomized to the trastuzumab arm ( DDFS P interaction = 0.025 ) .
CONCLUSIONS	Higher levels of TILs present at diagnosis were significantly associated with decreased distant recurrence rates in primary TNBC .
CONCLUSIONS	These results confirm our previous data and further support that TILs should be considered as a robust prognostic factor in this BC subtype .
CONCLUSIONS	We also report for the first time an association between higher levels of TILs and increased trastuzumab benefit in HER2 + disease .
CONCLUSIONS	Further research into why some TN and HER2 + BCs can or can not generate a host antitumor immune response and how trastuzumab can favorably alter the immune microenvironment is warranted .

###25403215
OBJECTIVE	We aimed to assess the impact of spin ( ie , reporting to convince readers that the beneficial effect of the experimental treatment is greater than shown by the results ) on the interpretation of results of abstracts of randomized controlled trials ( RCTs ) in the field of cancer .
METHODS	We performed a two-arm , parallel-group RCT .
METHODS	We selected a sample of published RCTs with statistically nonsignificant primary outcome and with spin in the abstract conclusion .
METHODS	Two versions of these abstracts were used-the original with spin and a rewritten version without spin .
METHODS	Participants were clinician corresponding authors of articles reporting RCTs , investigators of trials , and reviewers of French national grants .
METHODS	The primary outcome was clinicians ' interpretation of the beneficial effect of the experimental treatment ( 0 to 10 scale ) .
METHODS	Participants were blinded to study hypothesis .
RESULTS	Three hundred clinicians were randomly assigned using a Web-based system ; 150 clinicians assessed an abstract with spin and 150 assessed an abstract without spin .
RESULTS	For abstracts with spin , the experimental treatment was rated as being more beneficial ( mean difference , 0.71 ; 95 % CI , 0.07 to 1.35 ; P = .030 ) , the trial was rated as being less rigorous ( mean difference , -0.59 ; 95 % CI , -1.13 to 0.05 ; P = .034 ) , and clinicians were more interested in reading the full-text article ( mean difference , 0.77 ; 95 % CI , 0.08 to 1.47 ; P = .029 ) .
RESULTS	There was no statistically significant difference in the clinicians ' rating of the importance of the study or the need to run another trial .
CONCLUSIONS	Spin in abstracts can have an impact on clinicians ' interpretation of the trial results .

###26244306
BACKGROUND	Globally , herpes simplex virus type 2 ( HSV-2 ) infection is the most common cause of genital ulcer disease .
BACKGROUND	Effective prevention strategies for HSV-2 infection are needed to achieve the goals of the World Health Organization global strategy for the prevention and control of sexually transmitted infections .
METHODS	We assessed the effectiveness of pericoital tenofovir gel , an antiviral microbicide , in preventing HSV-2 acquisition in a subgroup of 422 HSV-2-negative women enrolled in the Centre for the AIDS Programme of Research in South Africa ( CAPRISA ) 004 study , a double-blind , randomized , placebo-controlled trial .
METHODS	Incident HSV-2 cases were identified by evidence of seroconversion on an HSV-2 IgG enzyme-linked immunosorbent assay between study enrollment and exit .
METHODS	A confirmatory analysis was performed by Western blot testing .
RESULTS	The HSV-2 incidence rate was 10.2 cases per 100 person-years ( 95 % confidence interval [ CI ] , 6.8 to 14.7 ) among 202 women assigned to tenofovir gel , as compared with 21.0 cases per 100 person-years ( 95 % CI , 16.0 to 27.2 ) among 222 women assigned to placebo gel ( incidence rate ratio , 0.49 ; 95 % CI , 0.30 to 0.77 ; P = 0.003 ) .
RESULTS	The HSV-2 incidence rate among the 25 women with vaginal tenofovir concentrations of 10,000 ng per milliliter or more was 5.7 cases per 100 person-years , as compared with 15.5 cases per 100 person-years among the 103 women with no detectable vaginal tenofovir ( incidence rate ratio , 0.37 ; 95 % CI , 0.04 to 1.51 ; P = 0.14 ) .
RESULTS	As confirmed by Western blot testing , there were 16 HSV-2 seroconversions among women assigned to tenofovir gel as compared with 36 among those assigned to the placebo gel ( incidence rate ratio , 0.45 ; 95 % CI , 0.23 to 0.82 ; P = 0.005 ) .
CONCLUSIONS	In this study in South Africa , pericoital application of tenofovir gel reduced HSV-2 acquisition in women .
CONCLUSIONS	( Funded by the U.S. Agency for International Development and others ; ClinicalTrials.gov number , NCT00441298 . )

###25212062
BACKGROUND	The implementation of a complex intervention is heavily influenced by individual context .
BACKGROUND	Variation in implementation and tailoring of the intervention to the particular context will occur , even in a trial setting .
BACKGROUND	It is recognised that in trials , evaluating the process of implementation of a complex intervention is important , yet process evaluation methods are rarely reported .
BACKGROUND	The WAVES study is a cluster randomised controlled trial to evaluate the effectiveness of an obesity prevention intervention programme targeting children aged 6-7 years , delivered by teachers in primary schools across the West Midlands , UK .
BACKGROUND	The intervention promoted activities encouraging physical activity and healthy eating .
BACKGROUND	This paper presents the methods used to assess implementation of the intervention .
METHODS	Previous literature was used to identify the dimensions of intervention process and implementation to be assessed , including adherence , exposure , quality of delivery , participant responsiveness , context , and programme differentiation .
RESULTS	Multiple methods and tools were developed to capture information on all these dimensions .
RESULTS	These included observations , logbooks , qualitative evaluation , questionnaires and research team reflection .
CONCLUSIONS	Data collection posed several challenges , predominantly when relying on teachers to complete paperwork , which they saw as burdensome on top of their teaching responsibilities .
CONCLUSIONS	However , the use of multiple methods helped to ensure data on each dimension , where possible , was collected using more than one method .
CONCLUSIONS	This also allowed for triangulation of the findings when several data sources on any one dimension were available .
CONCLUSIONS	We have reported a comprehensive approach to the assessment of the implementation and processes of a complex childhood obesity prevention intervention within a cluster randomised controlled trial .
CONCLUSIONS	These approaches can be transferred and adapted for use in other complex intervention trials .
BACKGROUND	ISRCTN97000586 .

###25567822
OBJECTIVE	Low-cost interventions to improve cancer screening among primary care patients are needed .
OBJECTIVE	The comparative effectiveness of personalized letters , automated telephone calls , and both on breast cancer ( BC ) and colorectal cancer ( CRC ) screening is not known .
METHODS	A pragmatic , randomized , controlled trial was conducted in 2011 to 2012 .
METHODS	Eligible primary care patients were women ages 50 to 74 years who were past due for mammography and men or women who were past due for mammography or CRC screening of any kind ( > 12 months since last fecal occult blood test , > 5 years since last sigmoidoscopy/double-contrast barium enema , or > 10 years since last colonoscopy ) , respectively .
METHODS	Participants were randomized to 1 of 3 interventions : personalized mailed letters , automated telephone calls , or both .
METHODS	The primary outcome was medical record documentation of a completed mammogram or CRC screening within 36 weeks of randomization .
METHODS	We estimated the costs of each intervention and calculated the marginal cost-effectiveness per person screened .
RESULTS	The crude screening rates for BC were 19 % , 22 % , and 37 % and for CRC were 17 % , 14 % , and 24 % for the letter , automated call , and combined ( letter/automated call ) groups , respectively .
RESULTS	The combined intervention group had a statistically higher screening rate ( P < .05 ) compared with either of the single intervention groups ( letter only or automated call ) for both BC and CRC in both the crude and adjusted analyses .
RESULTS	The combined intervention costs $ 5.11 per additional person screened for BC and $ 13.14 per additional person screened for CRC .
CONCLUSIONS	In a primary care practice , letters plus automated telephone calls are better than either alone in increasing cancer screening rates among patients who are overdue for screening .
CONCLUSIONS	These findings suggest the promise of a relatively inexpensive intervention to improve cancer screening .

###24806481
BACKGROUND	Graphic warnings ( GWs ) on cigarette packs are widely used internationally and perhaps will be in the US but their impact is not well understood .
BACKGROUND	This study tested support for competing hypotheses in different subgroups of young adults defined by their history of cigarette smoking and individual difference variables ( e.g. , psychological reactance ) .
BACKGROUND	One hypothesis predicted adaptive responding ( GWs would lower smoking-related intentions ) and another predicted defensive responding ( GWs would raise smoking-related intentions ) .
METHODS	Participants were an online sample of 1,169 Americans ages 18-24 , who were randomly assigned either to view nine GWs designed by the FDA or to a no-label control .
METHODS	Both the intention to smoke in the future and the intention to quit smoking ( among smokers ) were assessed before and after message exposure .
RESULTS	GWs lowered intention to smoke in the future among those with a moderate lifetime smoking history ( between 1 and 100 cigarettes ) , and they increased intention to quit smoking among those with a heavy lifetime smoking history ( more than 100 cigarettes ) .
RESULTS	Both effects were limited to individuals who had smoked in some but not all of the prior 30 days ( i.e. , occasional smokers ) .
RESULTS	No evidence of defensive `` boomerang effects '' on intention was observed in any subgroup .
CONCLUSIONS	Graphic warnings can reduce interest in smoking among occasional smokers , a finding that supports the adaptive-change hypothesis .
CONCLUSIONS	GWs that target occasional smokers might be more effective at reducing cigarette smoking in young adults .

###25573655
BACKGROUND	Little is known about diet quality with a reduced-energy , low-fat , partial meal replacement plan , especially in individuals with type 2 diabetes .
BACKGROUND	The Action for Health in Diabetes ( Look AHEAD ) trial implemented a partial meal replacement plan in the Intensive Lifestyle Intervention .
OBJECTIVE	To compare dietary intake and percent meeting fat-related and food group dietary recommendations in Intensive Lifestyle Intervention and Diabetes Support and Education groups at 12 months .
METHODS	A randomized controlled trial comparing Intensive Lifestyle Intervention with Diabetes Support and Education at 0 and 12 months .
METHODS	From 16 US sites , the first 50 % of participants ( aged 45 to 76 years , overweight or obese , with type 2 diabetes ) were invited to complete dietary assessments .
METHODS	Complete 0 - and 12-month dietary assessments ( collected between 2001 and 2004 ) were available for 2,397 participants ( 46.6 % of total participants ) , with 1,186 randomized to Diabetes Support and Education group and 1,211 randomized to Intensive Lifestyle Intervention group .
METHODS	A food frequency questionnaire assessed intake : energy ; percent energy from protein , fat , carbohydrate , polyunsaturated fatty acids , and saturated fats ; trans-fatty acids ; cholesterol ; fiber ; weekly meal replacements ; and daily servings from food groups from the Food Guide Pyramid .
METHODS	Mixed-factor analyses of covariance , using Proc MIXED with a repeated statement , with age , sex , race/ethnicity , education , and income controlled .
METHODS	Unadjusted tests compared percent meeting fat-related and food group recommendations at 12 months .
RESULTS	At 12 months , Intensive Lifestyle Intervention participants had a significantly lower fat and cholesterol intake and greater fiber intake than Diabetes Support and Education participants .
RESULTS	Intensive Lifestyle Intervention participants consumed more servings per day of fruits ; vegetables ; and milk , yogurt , and cheese ; and fewer servings per day of fats , oils , and sweets than Diabetes Support and Education participants .
RESULTS	A greater percentage of Intensive Lifestyle Intervention participants than Diabetes Support and Education participants met fat-related and most food group recommendations .
RESULTS	Within Intensive Lifestyle Intervention , a greater percentage of participants consuming two or more meal replacements per day than participants consuming less than one meal replacement per day met most fat-related and food group recommendations .
CONCLUSIONS	The partial meal replacement plan consumed by Intensive Lifestyle Intervention participants was related to superior diet quality .

###25332476
BACKGROUND	Apolioprotein E ( APOE ) genotype is reported to influence a person 's fasting lipid profile and potentially the response to dietary fat manipulation .
BACKGROUND	The impact of APOE genotype on the responsiveness to meals of varying fat composition is unknown .
OBJECTIVE	We examined the effect of meals containing 50 g of fat rich in saturated fatty acids ( SFAs ) , unsaturated fatty acids ( UNSATs ) , or SFAs with fish oil ( SFA-FO ) on postprandial lipemia .
METHODS	A randomized , controlled , test meal study was performed in men recruited according to the APOE genotype ( n = 10 APOE3/3 , n = 11 APOE3/E4 ) .
RESULTS	For the serum apoE response ( meal genotype interaction P = 0.038 ) , concentrations were on average 8 % lower after the UNSAT than the SFA-FO meal in APOE4 carriers ( P = 0.015 ) only .
RESULTS	In the genotype groups combined , there was a delay in the time to reach maximum triacylglycerol ( TG ) concentration ( mean SEM : 313 25 vs. 266 27 min ) and higher maximum nonesterified fatty acid ( 0.73 0.05 vs. 0.60 0.03 mmol/L ) and glucose ( 7.92 0.22 vs. 7.25 0.22 mmol/L ) concentrations after the SFA than the UNSAT meal , respectively ( P 0.05 ) .
RESULTS	In the Svedberg flotation rate 60-400 TG-rich lipoprotein fraction , meal genotype interactions were observed for incremental area under the curve ( IAUC ) for the TG ( P = 0.038 ) and apoE ( P = 0.016 ) responses with a 58 % lower apoE IAUC after the UNSAT than the SFA meal ( P = 0.017 ) in the E4 carriers .
CONCLUSIONS	Our data indicate that APOE genotype had a modest impact on the postprandial response to meals of varying fat composition in normolipidemic men .
CONCLUSIONS	The physiologic importance of greater apoE concentrations after the SFA-rich meals in APOE4 carriers may reflect an impact on TG-rich lipoprotein clearance from the circulation .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01522482 .

###24586896
OBJECTIVE	In obese women , 1 ) to assess whether lower gestational weight gain ( GWG ) during pregnancy in the lifestyle intervention group of a randomized controlled trial ( RCT ) resulted in differences in offspring anthropometrics and body composition , and 2 ) to compare offspring outcomes to a reference group of children born to women with a normal Body Mass Index ( BMI ) .
METHODS	The LiPO ( Lifestyle in Pregnancy and Offspring ) study was an offspring follow-up of a RCT with 360 obese pregnant women with a lifestyle intervention during pregnancy including dietary advice , coaching and exercise .
METHODS	The trial was completed by 301 women who were eligible for follow-up .
METHODS	In addition , to the children from the RCT , a group of children born to women with a normal BMI were included as a reference group .
METHODS	At 2.8 ( range 2.5-3 .2 ) years , anthropometrics were measured in 157 children of the RCT mothers and in 97 reference group children with Body Mass Index ( BMI ) Z-score as a primary outcome .
METHODS	Body composition was estimated by Dual Energy X-ray ( DEXA ) in 123 successful scans out of 147 ( 84 % ) .
RESULTS	No differences between randomized groups were seen in mean ( 95 % C.I. ) BMI Z-score ( intervention group 0.06 [ -0.17 ; 0.29 ] vs. controls -0.18 [ -0.43 ; 0.05 ] ) , in the percentage of overweight or obese children ( 10.9 % vs. 6.7 % ) , in other anthropometrics , or in body composition values by DEXA .
RESULTS	Outcomes between children from the RCT and the reference group children were not significantly different .
CONCLUSIONS	The RCT with lifestyle intervention in obese pregnant women did not result in any detectable effect on offspring anthropometrics or body composition by DEXA at 2.8 years of age .
CONCLUSIONS	This may reflect the limited difference in GWG between intervention and control groups .
CONCLUSIONS	Offspring of obese mothers from the RCT were comparable to offspring of mothers with a normal BMI .

###24890250
BACKGROUND	In the past 50 years , individual patient involvement at the clinical consultation level has received considerable attention .
BACKGROUND	More recently , patients and the public have increasingly been involved in collective decisions concerning the improvement of health care and policymaking .
BACKGROUND	However , rigorous evaluation guiding the development and implementation of effective public involvement interventions is lacking .
BACKGROUND	This article describes those key ingredients likely to affect public members ' ability to deliberate productively with professionals and influence collective health care choices .
METHODS	We conducted a trial process evaluation of public involvement in setting priorities for health care improvement .
METHODS	In all , 172 participants ( including 83 patients and public members and 89 professionals ) from 6 Health and Social Services Centers in Canada participated in the trial .
METHODS	We video-recorded 14 one-day meetings , and 2 nonparticipant observers took structured notes .
METHODS	Using qualitative analysis , we show how public members influenced health care improvement priorities .
RESULTS	Legitimacy , credibility , and power explain the variations in the public members ' influence .
RESULTS	Their credibility was supported by their personal experience as patients and caregivers , the provision of a structured preparation meeting , and access to population-based data from their community .
RESULTS	Legitimacy was fostered by the recruitment of a balanced group of participants and by the public members ' opportunities to draw from one another 's experience .
RESULTS	The combination of small-group deliberations , wider public consultation , and a moderation style focused on effective group process helped level out the power differences between professionals and the public .
RESULTS	The engagement of key stakeholders in the intervention design and implementation helped build policy support for public involvement .
CONCLUSIONS	A number of interacting active ingredients structure and foster the public 's legitimacy , credibility , and power .
CONCLUSIONS	By paying greater attention to them , policymakers could develop and implement more effective public involvement interventions .

###25615566
OBJECTIVE	Observational studies show that when a depressed mother 's symptoms remit , her children 's psychiatric symptoms decrease .
OBJECTIVE	Using randomized treatment assignment , the authors sought to determine the differential effects of a depressed mother 's treatment on her child .
METHODS	The study was a randomized double-blind 12-week trial of escitalopram , bupropion , or the combination of the two in depressed mothers ( N = 76 ) , with independent assessment of their children ( N = 135 ; ages 7-17 years ) .
RESULTS	There were no significant treatment differences in mothers ' depressive symptoms or remission .
RESULTS	Children 's depressive symptoms and functioning improved significantly among those whose mothers were in the escitalopram group ( compared with those whose mothers were in the bupropion and combination treatment groups ) .
RESULTS	Only in the escitalopram group was significant improvement of mother 's depression associated with improvement in the child 's symptoms .
RESULTS	Exploratory analyses suggested that this may be due to changes in parental functioning : Mothers in the escitalopram group reported significantly greater improvement , compared with the other groups , in their ability to listen and talk to their children , who as a group reported that their mothers were more caring over the 12 weeks .
RESULTS	Maternal baseline negative affectivity appeared to moderate the effect of maternal treatment on children , although the effect was not statistically significant .
RESULTS	Children of mothers with low negative affectivity improved in all treatment groups .
RESULTS	Children of mothers with high negative affectivity improved significantly only for those whose mothers were in the escitalopram group .
CONCLUSIONS	The effects of the depressed mother 's improvement on her children may depend on her type of treatment .
CONCLUSIONS	Depressed mothers with high anxious distress and irritability may require medications that reduce these symptoms in order to show the effect of her remission on her children .

###24858669
OBJECTIVE	To systematically test the cumulative effect of the M Technique on infant neurodevelopment in hospitalized very preterm infants .
METHODS	A pilot randomized controlled trial ( RCT ) .
METHODS	Twenty very preterm infants ( < 30 weeks gestation with average birth weights < 1000 g ) were randomly assigned to nontreatment or treatment groups .
METHODS	The study period began once the infants reached 30 weeks postmenstrual age ( PMA ) .
METHODS	Each infant received standard neonatal intensive unit ( NICU ) care or standard NICU care plus a 7-minute M Technique session , 6 times per week for 5 weeks .
METHODS	Neurobehavioral development ( using the NICU Network Neurobehavioral Scale [ NNNS ] ) and growth velocity ( difference in infant weight at the beginning and end of protocol ) were compared between the 2 groups .
METHODS	Physiologic parameters ( heart rate , respiratory rate , and oxygen saturations ) and infant behavioral states were measured 5 minutes before , during , and up to 10 minutes postintervention continuously on all infants in the treatment group at 3 different gestational time points ( 30 , 32 , and 34 weeks PMA ) over the 5-week period .
RESULTS	Mann-Whitney U analyses revealed no differences between the 2 groups on all 12 NNNS summary score domains but a difference in growth velocity between the 2 groups ( P = 0.005 ) .
RESULTS	Repeated-measures analysis of variance revealed significant physiologic differences of mean heart rate , respiratory rate , and SaO2 ( F = 41.116 , P < 0.0005 ) and behavioral states ( F = 38.564 , P < 0.0005 ) from baseline to 10 minutes after the M Technique intervention across all 3 time points .
RESULTS	State scores decreased from baseline ( M = 6.11 ) to post intervention ( M = 1.4 ) at all 3 time points .
CONCLUSIONS	This pilot RCT demonstrates the utility of the M Technique in hospitalized very preterm infants starting at 30 weeks PMA with notable evidence of positive weight , physiological , and behavioral state adaptations .
CONCLUSIONS	Additional research is needed with a larger , randomized design to determine short - and long-term effects specifically related to neurological outcomes .

###25251999
OBJECTIVE	Two phase I , single-blind ( subject blinded to treatment ) , randomized studies were conducted to assess the pharmacodynamics , pharmacokinetics , safety , and tolerability of lipegfilgrastim compared with pegfilgrastim in healthy adult volunteers .
METHODS	Study 1 consisted of a pilot safety phase ( N = 8 ) during which subjects received a single body-weight-adjusted subcutaneous dose of lipegfilgrastim 25 g/kg and a dose escalation phase ( N = 45 ) wherein subjects received lipegfilgrastim 50 or 100 g/kg or pegfilgrastim 100 g/kg .
METHODS	Study 2 was a single-blind , fixed-dose study ( N = 36 ) comparing subcutaneous lipegfilgrastim 6 mg and pegfilgrastim 6 mg .
RESULTS	Cumulative exposure ( AUC0-t last and AUC 0 - ) and peak exposure ( Cmax ) were higher for lipegfilgrastim than pegfilgrastim after both weight-adjusted and fixed dosing .
RESULTS	In both studies , the terminal elimination half-life of lipegfilgrastim was 5-10 hours longer than the terminal elimination half-life for pegfilgrastim at the maximum dose , and the time to maximum serum concentration ( tmax ) was observed later for lipegfilgrastim than for pegfilgrastim .
RESULTS	The area over the baseline effect curve ( AOBEC ) for absolute neutrophil count ( ANC ) was approximately 30 % greater after lipegfilgrastim dosing compared with the same dose of pegfilgrastim at the maximum dose .
RESULTS	Both drugs were well tolerated , with a similar occurrence of adverse events between treatment groups .
RESULTS	Key limitations of these studies include the small numbers of subjects and differences in dosage regimens between the two studies .
CONCLUSIONS	In these studies , lipegfilgrastim provided a longer-lasting increase in ANC compared with pegfilgrastim at an equivalent dose , without increasing the peak ANC values .
CONCLUSIONS	This may reflect the higher cumulative exposure and slower clearance ( therefore longer body residence ) of lipegfilgrastim .
CONCLUSIONS	These data support the use of single-dose lipegfilgrastim 6 mg in subsequent phase III trials as prophylactic treatment for patients receiving myelosuppressive chemotherapy .

###25783434
OBJECTIVE	To determine whether changes in theory of planned behaviour ( TPB ) constructs could predict intention and gluten-free diet ( GFD ) adherence following participation in an online theory-based intervention designed to improve adherence in coeliac disease .
METHODS	Theory-based process evaluation of the mechanisms of change over the course of a six-week online intervention .
METHODS	Measures of GFD adherence and TPB variables were administered at baseline and follow-up ( immediate post-intervention : n = 74 ; three-month : n = 68 ; six-month : n = 65 ) .
METHODS	Hierarchical regression analyses using residualised change scores were conducted at each time point ( dependent variables : intention and adherence ) .
RESULTS	Baseline intention and GFD adherence were the strongest predictors of follow-up intention and adherence , respectively .
RESULTS	Change in attitude accounted for significant variance in intention .
RESULTS	Change in intention accounted for significant variance in GFD adherence immediately post-intervention ; by the six-month follow-up change in perceived behavioural control was the stronger predictor .
CONCLUSIONS	Partial support for the hypotheses suggests that , for certain behaviours , the TPB may be relevant in explaining the mechanism of action responsible for changes in intention and behaviour following participation in a behaviour change intervention .
CONCLUSIONS	Additional predictive pathways are also likely to exist and , in the area of GFD adherence , may include habit strength and actual behavioural control .

###25263513
OBJECTIVE	Cooling the pharynx and upper oesophagus would be more advantageous for rapid induction of therapeutic hypothermia since the carotid arteries run in their vicinity .
OBJECTIVE	The aim of this study was to determine the effects of pharyngeal cooling on brain temperature and the safety and feasibility for patients under resuscitation .
METHODS	Witnessed non-traumatic cardiac arrest patients ( n = 108 ) were randomized to receive standard care with ( n = 53 ) or without pharyngeal cooling ( n = 55 ) .
METHODS	In the emergency room , pharyngeal cooling was initiated before or shortly after return of spontaneous circulation by perfusing physiological saline ( 5 C ) into a pharyngeal cuff for 120 min .
RESULTS	There was a significant decrease in tympanic temperature at 40 min after arrival ( P = 0.02 ) with a maximum difference between the groups at 120 min ( 32.9 1.2 C , pharyngeal cooling group vs. 34.1 1.3 C , control group ; P < 0.001 ) .
RESULTS	The return of spontaneous circulation ( 70 % vs. 65 % , P = 0.63 ) and rearrest ( 38 % vs. 47 % , P = 0.45 ) rates were not significantly different based on the initiation of pharyngeal cooling .
RESULTS	No post-treatment mechanical or cold-related injury was observed on the pharyngeal epithelium by macroscopic observation .
RESULTS	The thrombocytopaenia incidence was lower in the pharyngeal cooling group ( P = 0.001 ) during the 3-day period after arrival .
RESULTS	The cumulative survival rate at 1 month was not significantly different between the two groups .
CONCLUSIONS	Initiation of pharyngeal cooling before or immediately after the return of spontaneous circulation is safe and feasible .
CONCLUSIONS	Pharyngeal cooling can rapidly decrease tympanic temperature without adverse effects on circulation or the pharyngeal epithelium .

###25293478
BACKGROUND	Tracheal intubation is one of the strongest stimuli during general anaesthesia and may result in an insufficient depth of anaesthesia .
BACKGROUND	The aim of the study was to compare the clinical evaluation of the depth of anaesthesia with an evaluation using entropy during inhalational and intravenous induction of general anaesthesia .
METHODS	This study involved 60 patients undergoing elective surgery under general anaesthesia .
METHODS	Patients were divided into two groups , group E ( etomidate induction ) and group S ( sevoflurane induction ) .
METHODS	The systolic arterial pressure ( SAP ) , heart rate ( HR ) , response entropy ( RE ) , and state entropy ( SE ) were determined at the following seven measurement points : before anaesthesia induction , at the loss of consciousness ( LOC ) point , before tracheal intubation , immediately after intubation , and 2 min. , 4 min .
METHODS	and 6 min .
METHODS	after tracheal intubation .
METHODS	An increase in HR and/or SAP of more than 20 % and/or the occurrence of lacrimation and/or perspiration in response to tracheal intubation was considered a marker of inadequate anaesthesia in the clinical evaluation .
METHODS	The depth of anaesthesia was considered insufficient according to entropy monitoring if the RE and SE were above 60 .
RESULTS	In clinical evaluation , insufficient anaesthesia in response to tracheal intubation was observed in all the patients in group E and in more than half of the patients in group S.
RESULTS	At the same time , the majority of patients in both groups had entropy values that did not exceed the recommended value as an appropriate level of anaesthesia .
CONCLUSIONS	We found a discrepancy in the evaluation of the depth of anaesthesia based on clinical criteria compared with evaluations based on entropy values during both intravenous and inhalational induction of general anaesthesia .

###25937443
BACKGROUND	Current treatment of ischaemic stroke with thrombolytic therapy is restricted to 3-45 h after symptom onset .
BACKGROUND	We aimed to assess the safety and efficacy of desmoteplase , a fibrin-dependent plasminogen activator , given between 3 h and 9 h after symptom onset in patients with occlusion or high-grade stenosis in major cerebral arteries .
METHODS	In a prospective , double-blind , multicentre , parallel-group , randomised trial , we enrolled patients from 77 hospitals in 17 countries who had ischaemic stroke and occlusion or high-grade stenosis in major cerebral arteries .
METHODS	We randomly assigned patients in a 1:1 ratio , using computer-generated randomisation lists with stratification for baseline National Institutes of Health Stroke Scale and age , to treatment with desmoteplase ( 90 g/kg ) given 3-9 h after symptom onset or to placebo .
METHODS	Patients , investigators , staff , and the funder were masked to treatment assignment .
METHODS	The primary outcome was a favourable modified Rankin Scale score ( 0-2 ) at day 90 in all treated patients who had at least one postbaseline measurement of the modified Rankin Scale .
METHODS	Safety was assessed in all randomly assigned patients who received study drugs .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00790920 .
RESULTS	Between Feb 6 , 2009 , and Nov 27 , 2013 , we enrolled 492 patients and randomly assigned 247 to desmoteplase and 245 to placebo ( 236 in the desmoteplase group and 237 in the placebo group were included in the analysis of the primary endpoint ) .
RESULTS	Median time from stroke onset to treatment was 69 h ( IQR 57-80 ) for placebo and 70 h ( 60-79 ) for desmoteplase .
RESULTS	Modified Rankin Scale score ( 0-2 ) at day 90 occurred in 121 ( 51 % ) patients given desmoteplase and 118 ( 50 % ) patients given placebo ( adjusted odds ratio 120 , 95 % CI 079-181 , p = 040 ) .
RESULTS	24 ( 10 % ) of 240 patients given desmoteplase died compared with 23 ( 10 % ) of 238 patients given placebo .
RESULTS	Serious adverse events occurred in 64 ( 27 % ) of 240 patients receiving desmoteplase compared with 69 ( 29 % ) of 238 patients receiving placebo ; frequency of symptomatic intracranial haemorrhage ( six [ 3 % ] patients in the desmoteplase group vs five [ 2 % ] in the placebo group ) , symptomatic cerebral oedema ( five [ 2 % ] vs four [ 2 % ] ) , and major haemorrhage ( ten [ 4 % ] vs 15 [ 6 % ] ) was much the same between treatment groups .
CONCLUSIONS	Treatment with desmoteplase did not cause safety concerns and did not improve functional outcome when given to patients who had ischaemic stroke and major cerebral artery occlusion beyond 3 h of symptom onset .
BACKGROUND	H Lundbeck A/S .

###25525163
OBJECTIVE	Beneficial effects of dietary supplements in age-related macular degeneration ( AMD ) are related to antioxidative properties .
OBJECTIVE	In the Age-Related Eye Disease Study 1 ( AREDS 1 ) , a reduced progression to late stage AMD was found using vitamin C , E , zinc , and - carotene .
OBJECTIVE	We showed previously that the AREDS 1 formulation restores the O2-induced retinal vasoconstrictor response of retinal vessels in a human endotoxin ( lipopolysaccharide [ LPS ] ) model .
METHODS	We hypothesized that the abnormal O2-induced retinal red blood cell ( RBC ) flow response can be modulated by a different formulation ( vitamin C , E , and zinc , lutein/zeaxanthin , selenium , taurine , Aronia extract , and omega-3 free fatty acids ) .
METHODS	A total of 43 healthy subjects was included in this randomized , double masked , placebo-controlled parallel group study .
METHODS	The reactivity of retinal arterial and venous diameter , RBC velocity , and flow to 100 % O2 breathing was investigated in the absence and presence of 2 ng/kg LPS .
METHODS	Between the two study days was a 14-day period of daily dietary supplement intake .
RESULTS	The decrease in retinal arterial diameter , RBC velocity , and flow during 100 % O2 breathing was diminished significantly after LPS infusion .
RESULTS	Dietary supplement intake for 14 days almost restored the response of retinal hemodynamic parameters to 100 % O2 after LPS administration .
RESULTS	This effect was significant for retinal arterial diameter ( P = 0.03 between groups ) , and RBC velocity and flow ( each P < 0.01 between groups ) .
CONCLUSIONS	The present data indicate restoring of the RBC flow response to 100 % O2 after LPS administration .
CONCLUSIONS	This is likely due to an amelioration of endothelial dysfunction resulting from oxidative stress , a factor involved in AMD pathophysiology .
CONCLUSIONS	( ClinicalTrials.gov number , NCT00914576 . )

###26075375
OBJECTIVE	To compare the performance and effectiveness of a hydrocolloid dressing ( HD ) and a transparent polyurethane film ( PF ) in preventing pressure ulcer ( PU ) development .
METHODS	The study was conducted in the intensive care unit , coronary care unit and medical clinic of the Holy House of Mercy of Passos , Brazil .
METHODS	Data were collected 48 hours after admission and during hospitalisation .
METHODS	The Braden scale was used for PU risk assessment .
METHODS	Consecutive eligible patients without PUs were randomly assigned by lottery to the two groups , either the HD or PF group .
RESULTS	Of the 160 eligible patients , significant between-group differences were found in the mean total number of dressing changes ( HD , 6.091.655 changes ; PF , 5.592.036 changes ; p = 0.010 ) , and mean number of dressing changes in the sacral region ( HD , 2.500.871 ; PF , 2.050.825 ; p = 0.001 ) , with the PF group requiring significantly fewer changes than the HD group .
RESULTS	The most common reasons for changing dressings in both groups were moisture ( PF 51.1 % ; HD 47.9 % ) and shear ( HD 43 % ; PF 38.9 % ) , with a significant difference in shear between groups .
RESULTS	The incidence of PUs was significantly lower ( p = 0.038 ) in the PF group ( 8.7 % ) compared with that in the HD group ( 15 % ) .
CONCLUSIONS	The results suggest that the transparent polyurethane film had a better performance and was more effective than the hydrocolloid dressing in preventing PU development .

###24306002
OBJECTIVE	To evaluate Bacille Calmette-Gurin ( BCG ) effects after clinically isolated syndromes ( CIS ) .
METHODS	In a double-blind , placebo-controlled trial , participants were randomly assigned to receive BCG or placebo and monitored monthly with brain MRI ( 6 scans ) .
METHODS	Both groups then entered a preplanned phase with IM interferon -- 1a for 12 months .
METHODS	From month 18 onward , the patients took the disease-modifying therapies ( DMTs ) that their neurologist considered indicated in an open-label extension phase lasting up to 60 months .
RESULTS	Of 82 randomized subjects , 73 completed the study ( 33 vaccinated and 40 placebo ) .
RESULTS	During the initial 6 months , the number of cumulative lesions was significantly lower in vaccinated people .
RESULTS	The relative risks were 0.541 ( 95 % confidence interval [ CI ] 0.308-0 .956 ; p = 0.03 ) for gadolinium-enhancing lesions ( the primary endpoint ) , 0.364 ( 95 % CI 0.207-0 .639 ; p = 0.001 ) for new and enlarging T2-hyperintense lesions , and 0.149 ( 95 % CI 0.046-0 .416 ; p = 0.001 ) for new T1-hypointense lesions .
RESULTS	The number of total T1-hypointense lesions was lower in the BCG group at months 6 , 12 , and 18 : mean changes from baseline were -0.09 0.72 vs 0.75 1.81 ( p = 0.01 ) , 0.0 0.83 vs 0.88 2.21 ( p = 0.08 ) , and -0.21 1.03 vs 1.00 2.49 ( p = 0.02 ) .
RESULTS	After 60 months , the cumulative probability of clinically definite multiple sclerosis was lower in the BCG + DMT arm ( hazard ratio = 0.52 , 95 % CI 0.27-0 .99 ; p < 0.05 ) , and more vaccinated people remained DMT-free ( odds ratio = 0.20 , 95 % CI 0.04-0 .93 ; p = 0.04 ) .
CONCLUSIONS	Early BCG may benefit CIS and affect its long-term course .
METHODS	BCG , as compared to placebo , was associated with significantly reduced development of gadolinium-enhancing lesions in people with CIS for a 6-month period before starting immunomodulating therapy ( Class I evidence ) .

###24268845
OBJECTIVE	To systematically investigate chemotherapy versus chemotherapy followed by involved field radiotherapy for limited-stage aggressive non-Hodgkin 's lymphoma .
METHODS	A systematic literature search of Pubmed , EMBASE , and the Cochrane central register of controlled trials was performed .
METHODS	Data from all randomized controlled trials comparing chemotherapy alone with chemotherapy followed by involved field radiotherapy in patients with limited-stage aggressive non-Hodgkin 's lymphoma was collaborate .
METHODS	The primary outcome was overall survival ; secondary outcomes were event-free survival and cumulative incidences of toxicity .
RESULTS	Three randomized controlled trials , with 1263 participants in total , were analyzed .
RESULTS	Median follow-up was 11 years .
RESULTS	Patients receiving chemotherapy followed by involved field radiotherapy had a significant benefit on event-free survival ( hazards ratio [ HR ] = 1.47 , 95 % confidence interval [ CI ] : 1.14 to 1.90 ; P = 0.003 ) , but not improved overall survival ( HR = 1.00 , 95 % CI : 0.80 to 1.25 ; P = 0.978 ) at 8 years , in relation to those in the chemotherapy alone arm .
RESULTS	There were great differences in the reporting of cumulative incidences of toxicity .
CONCLUSIONS	Chemotherapy followed by involved field radiotherapy , as compared with chemotherapy alone , is associated with better event-free survival , but no survival benefit is observed for patients for limited-stage aggressive non-Hodgkin 's lymphoma .
CONCLUSIONS	These results needed to be confirmed by high quality trials and further studies in the East .

###24725075
OBJECTIVE	Transcranial direct current stimulation ( tDCS ) is a neuromodulatory intervention with recent clinical trials showing promising results in major depression treatment .
OBJECTIVE	Although tDCS has some appealing characteristics ( e.g. , low cost , ease of use , and relatively benign profile of adverse effects ) , one important drawback of the technique is the need to deliver consecutive , repeated sessions for several weekdays .
OBJECTIVE	However , no study investigated whether absences during this acute treatment phase impact on tDCS efficacy , and , if so , whether absences should be considered dropouts , therefore increasing attrition .
METHODS	To examine this issue , we used data from a randomized , factorial , sham-controlled tDCS study that recruited 120 depressed patients .
METHODS	In this trial , the acute treatment phase consisted of ten consecutive sessions delivered once daily from Monday to Friday ; two nonconsecutive missed visits were allowed , with extra tDCS sessions being performed to complete the original number of sessions .
RESULTS	Our main finding was that the procedure of granting one to two absences during the acute treatment phase did not impact on tDCS antidepressant efficacy .
RESULTS	Moreover , out of 103 completers , only 41 ( 39.8 % ) patients presented no missing visits and 25 ( 24.3 % ) presented two absences .
RESULTS	These patients did not differ in clinical and demographic characteristics ; thus , absences were probably circumstantial ( e.g. , traffic congestion , personal obligations ) .
CONCLUSIONS	Absences during the acute tDCS treatment phase are common , which support the use of flexible schedules in future tDCS trials as to minimize attrition .
CONCLUSIONS	Also , further studies should access whether higher number of absences can compromise optimal tDCS efficacy .

###25596097
OBJECTIVE	To evaluate postural changes and the distribution of plantar pressures in patients with cystic fibrosis ( CF ) .
OBJECTIVE	We also sought to evaluate the effects of an educational guideline for physical activity on body posture in children and adolescents with CF.
METHODS	This was a 2-phase study of individuals between age 7 and 20 years .
METHODS	Phase I was a cross-sectional study in which healthy subjects were selected for postural evaluation and baropodometry , aiming to perform a later comparison with patients with CF. In phase II , we performed a randomized controlled clinical trial to assess the influence of the exercise guideline on the postural changes .
METHODS	Patients were assigned to 2 groups : control and intervention .
METHODS	The intervention consisted of a handbook with instructions for aerobic exercise and stretching .
METHODS	Main outcomes were postural abnormalities , plantar pressure distribution , and lung function .
RESULTS	In phase I , 34 patients with CF and 34 healthy matched individuals were included .
RESULTS	No significant baseline differences were identified .
RESULTS	Children with CF presented more postural deviations compared with healthy subjects ( P < .05 ) , as to alignment of the head , shoulder girdle , and pelvis , increased cervical lordosis , and lateral chest distance .
RESULTS	In phase II ( n = 34 ) , there were no baseline differences between groups .
RESULTS	The intervention caused ( P < .05 ) a decrease in cervical lordosis , thoracic kyphosis , lumbar lordosis , lateral chest distance , and abdominal protrusion , as well as in the baropodometric mean pressure and contact area .
CONCLUSIONS	Children and adolescents with CF present postural changes when compared with healthy individuals .
CONCLUSIONS	The educational guideline for exercise practice helped to improve posture , preventing the progression of some postural disorders .

###25545240
OBJECTIVE	To evaluate the efficacy and safety of adalimumab in patients with active nonpsoriatic peripheral spondyloarthritis ( SpA ) .
METHODS	ABILITY-2 is an ongoing phase III , multicenter study of adalimumab treatment .
METHODS	Eligible patients age 18 years fulfilled the Assessment of SpondyloArthritis international Society ( ASAS ) classification criteria for peripheral SpA , did not have a prior diagnosis of psoriasis , psoriatic arthritis ( PsA ) , or ankylosing spondylitis ( AS ) , and had an inadequate response or intolerance to nonsteroidal antiinflammatory drugs ( NSAIDs ) .
METHODS	Patients were randomized 1:1 to receive adalimumab 40 mg every other week or matching placebo for 12 weeks , followed by a 144-week open-label period .
METHODS	The primary end point was the proportion of patients achieving 40 % improvement in disease activity according to the Peripheral SpA Response Criteria ( PSpARC40 ) at week 12 .
METHODS	This was defined as 40 % improvement from baseline ( 20-mm absolute improvement on a visual analog scale ) in patient 's global assessments of disease activity and pain , and 40 % improvement in at least one of the following features : swollen joint and tender joint counts , total enthesitis count , or dactylitis count .
METHODS	Adverse events were recorded throughout the study .
RESULTS	In total , 165 patients were randomized to a treatment group , of whom 81 were randomized to receive placebo and 84 to receive adalimumab .
RESULTS	Baseline demographics and disease characteristics were generally similar between the 2 groups .
RESULTS	At week 12 , a greater proportion of patients receiving adalimumab achieved a PSpARC40 response compared to patients receiving placebo ( 39 % versus 20 % ; P = 0.006 ) .
RESULTS	Overall , improvement in other outcomes was greater in the adalimumab group compared to the placebo group .
RESULTS	The rates of adverse events were similar in both treatment groups .
CONCLUSIONS	Treatment with adalimumab ameliorated the signs and symptoms of disease and improved physical function in patients with active nonpsoriatic peripheral SpA who exhibited an inadequate response or intolerance to NSAIDs , with a safety profile consistent with that observed in patients with AS , PsA , or other immune-mediated diseases .

###24690625
OBJECTIVE	To determine whether the probiotic Lactobacillus reuteri DSM 17938 reduces crying or fussing in a broad community based sample of breastfed infants and formula fed infants with colic aged less than 3 months .
METHODS	Double blind , placebo controlled randomised trial .
METHODS	Community based sample ( primary and secondary level care centres ) in Melbourne , Australia .
METHODS	167 breastfed infants or formula fed infants aged less than 3 months meeting Wessel 's criteria for crying or fussing : 85 were randomised to receive probiotic and 82 to receive placebo .
METHODS	Oral daily L reuteri ( 1 10 ( 8 ) colony forming units ) versus placebo for one month .
METHODS	The primary outcome was daily duration of cry or fuss at 1 month .
METHODS	Secondary outcomes were duration of cry or fuss ; number of cry or fuss episodes ; sleep duration of infant at 7 , 14 , and 21 days , and 1 and 6 months ; maternal mental health ( Edinburgh postnatal depression subscale ) ; family functioning ( paediatric quality of life inventory ) , parent quality adjusted life years ( assessment of quality of life ) at 1 and 6 months ; infant functioning ( paediatric quality of life inventory ) at 6 months ; infant faecal microbiota ( microbial diversity , colonisation with Escherichia coli ) , and calprotectin levels at 1 month .
METHODS	In intention to treat analyses the two groups were compared using regression models adjusted for potential confounders .
RESULTS	Of 167 infants randomised from August 2011 to August 2012 , 127 ( 76 % ) were retained to primary outcome ; of these , a subset was analysed for faecal microbial diversity , E coli colonisation , and calprotectin levels .
RESULTS	Adherence was high .
RESULTS	Mean daily cry or fuss time fell steadily in both groups .
RESULTS	At 1 month , the probiotic group cried or fussed 49 minutes more than the placebo group ( 95 % confidence interval 8 to 90 minutes , P = 0.02 ) ; this mainly reflected more fussing , especially for formula fed infants .
RESULTS	The groups were similar on all secondary outcomes .
RESULTS	No study related adverse events occurred .
CONCLUSIONS	L reuteri DSM 17938 did not benefit a community sample of breastfed infants and formula fed infants with colic .
CONCLUSIONS	These findings differ from previous smaller trials of selected populations and do not support a general recommendation for the use of probiotics to treat colic in infants .
BACKGROUND	Current Controlled Trials ISRCTN95287767 .

###25054399
BACKGROUND	The estimated prevalence of lumbar radiculopathy has been described as 9.8 per 1,000 cases of low back pain .
BACKGROUND	There are various surgical and nonsurgical modalities for treating lumbar disc herniation or radicular pain , including epidural injections .
BACKGROUND	Epidural injection administration routes include transforaminal , interlaminar , and caudal approaches .
BACKGROUND	The transforaminal approach requires the smallest volume to reach the primary site of pathology .
BACKGROUND	Systematic reviews have yielded highly variable results , but a recent systematic review showed no significant difference among the 3 approaches .
METHODS	A randomized , controlled , double blind , active control trial .
METHODS	An interventional pain management practice , a private specialty referral center in the United States .
OBJECTIVE	To assess the effectiveness of transforaminal epidural injections of local anesthetic with or without steroids in managing chronic low back and lower extremity pain in patients with disc herniation and radiculitis .
METHODS	One hundred twenty patients were randomly assigned to 2 groups : Group I received 1.5 mL of 1 % preservative-free lidocaine , followed by 0.5 mL of sodium chloride solution .
METHODS	Group II received 1 % lidocaine , followed by 3 mg , or 0.5 mL of betamethasone .
METHODS	The sodium chloride solution and betamethasone were either clear liquids or were provided in opaque-covered syringes .
METHODS	The primary outcome measure was significant improvement ( at least 50 % ) measured by the average Numeric Rating Scale ( NRS ) and the Oswestry Disability Index 2.0 ( ODI ) .
METHODS	Secondary outcome measures were employment status and opioid intake .
RESULTS	At 2 years there was significant improvement in all participants in 65 % who received local anesthetic alone and 57 % who received local anesthetic and steroid .
RESULTS	When separated into non-responsive and responsive categories based on initial relief of at least 3 weeks with 2 procedures , significant improvement ( at least 50 % improvement in pain and function ) was seen in 80 % in the local anesthetic group and 73 % in the local anesthetic with steroid group .
CONCLUSIONS	Presumed limitations of this evaluation include the lack of a placebo group .
CONCLUSIONS	Transforaminal epidural injections of local anesthetic with or without steroids might be an effective therapy for patients with disc herniation or radiculitis .
CONCLUSIONS	The present evidence illustrates the lack of superiority of steroids compared with local anesthetic at 2-year follow-up .

###24521323
OBJECTIVE	Attribution theory claims that people who are stigmatized experience more negative emotional and behavioral reactions from others when they are thought to be responsible for their problems .
OBJECTIVE	Accordingly , this study proposed a neurobiology-based psychoeducational intervention , which attempted to reduce people 's blameworthy attitudes toward and social distance from depressed individuals .
METHODS	One hundred and thirty-two college students were randomly assigned to an experimental and control group .
METHODS	Participants in the experimental group received a 30-min lecture on neurobiology-based psychoeducation for depressive disorders , and were asked to fill out questionnaires before and 2 weeks after the intervention .
METHODS	The control group , with no intervention , also filled out the same questionnaires before and 2 weeks after the experiment .
METHODS	The main contents of the neurobiology-based psychoeducation concerned the neurotransmission processes and biological mechanisms of depression , in order to emphasize the biological attribution of depression .
RESULTS	An ancova indicated that the neurobiology-based psychoeducational intervention significantly elevated the biological attribution of depression and reduced the social distance from depressed individuals .
RESULTS	Psychological blameworthy attitudes toward depression , however , did not significantly change .
CONCLUSIONS	Through a brief psychoeducation program about depression , knowledge of neuroscience could lead to positive benefits .
CONCLUSIONS	Public awareness that depression can be effectively prevented and treated may be a way in which people can accept depressed individuals .
CONCLUSIONS	Further studies are needed to certify the mechanisms of the effect of neurobiology-based psychoeducation .

###25117873
BACKGROUND	After injury , eccentric exercise of the injured limb is often contraindicated .
BACKGROUND	Cross-education training , whereby the uninvolved limb is exercised , is an alternative that may improve quadriceps muscle strength and activation in the unexercised limb .
OBJECTIVE	To determine the effect of eccentric exercise on quadriceps strength and activation gains in the unexercised limb .
METHODS	Eighteen healthy individuals were randomly assigned to an eccentric training group or a control group .
METHODS	Quadriceps strength and activation measures were collected at preintervention , midintervention , and postintervention .
METHODS	Eccentric training participants exercised their dominant limb with a dynamometer in eccentric mode at 60/s , 3 times per week for 8 weeks .
METHODS	Quadriceps strength was quantified at 30 and 60/s in concentric and eccentric modes .
METHODS	Quadriceps activation was assessed using the burst superimposition technique and quantified via the central activation ratio .
METHODS	A 2 3 repeated-measures analysis of variance was used to detect the effects of group and testing session on quadriceps strength and activation .
METHODS	Where appropriate , post hoc Bonferroni multiple-comparisons procedures were used .
RESULTS	We found greater eccentric strength in the unexercised limbs of eccentric training participants between preintervention and midintervention and between preintervention and postintervention ( preintervention to midintervention : 30/s P = .05 ; preintervention to postintervention : 30/s P = .02 , 60/s P = .02 ) .
RESULTS	No differences were noted in concentric strength ( P > .05 ) .
RESULTS	An overall trend toward greater quadriceps activation in the unexercised knee was detected between preintervention and postintervention ( P = .063 ) , with the eccentric training group demonstrating a strong effect ( Cohen d = 0.83 ) .
RESULTS	Control strength did not change ( P > .05 ) .
CONCLUSIONS	Exercising with eccentric actions resulted in mode-specific and velocity-specific gains in quadriceps strength in the unexercised limb .
CONCLUSIONS	A trend toward greater quadriceps activation in the unexercised knee was noted , suggesting that strength gains may have occurred because of enhanced neural activity .
CONCLUSIONS	This type of therapy may be a useful addition to rehabilitation programs designed to improve quadriceps strength .

###25213048
BACKGROUND	The inhaled corticosteroid fluticasone furoate ( FF ) in combination with the long-acting 2-agonist vilanterol ( VI ) is under development for the treatment of asthma and chronic obstructive pulmonary disease .
OBJECTIVE	To compare the efficacy and safety of FF-VI and FF in patients ( 12 years old ) with persistent asthma .
METHODS	In a randomized , double-blind , parallel-group study , patients ( n = 609 ) ( intent-to-treat population ) received FF-VI 100-25 mcg , FF 100 mcg , or placebo once daily ( evening ) by using a dry powder inhaler for 12 weeks .
METHODS	Coprimary end points were change from baseline in trough FEV1 and serial ( 0-24 hours ) weighted mean FEV1 ( wmFEV ( 1 ) ) .
METHODS	Rescue-free 24-hour periods and safety also were assessed .
RESULTS	Placebo increased trough FEV1 ( 196 mL ) and wmFEV ( 1 ) ( 212 mL ) versus baseline .
RESULTS	Compared with placebo , FF-VI and FF significantly improved trough FEV1 ( 172 mL [ P < .001 ] and 136 mL [ P = .002 ] ) , respectively , and serial wmFEV ( 1 ) ( 302 mL [ P < .001 ] and 186 mL [ P = .003 ] ) , respectively .
RESULTS	Treatment differences between FF-VI and FF approached significance for serial wmFEV ( 1 ) ( 116 mL ; P = .060 ) but not for trough FEV1 ( 36 mL ; P = .405 ) .
RESULTS	The percentage of rescue-free 24-hour periods with FF-VI was 10.6 % greater than FF and 19.3 % greater than placebo .
RESULTS	Statistically significant ( P = .032 ) urinary cortisol suppression was observed with FF-VI ( ratio , 0.82 ) relative to placebo , but not with FF .
RESULTS	Adverse event and safety profiles were similar across treatment groups .
CONCLUSIONS	Significant improvement in lung function was observed with FF-VI and FF versus placebo in patients with persistent asthma .
CONCLUSIONS	Improvement of FEV1 when VI was added to FF was not significant .
CONCLUSIONS	The high placebo response in evening trough FEV1 may have influenced the assessment of efficacy .

###24381967
OBJECTIVE	Although vitamin E and memantine have been shown to have beneficial effects in moderately severe Alzheimer disease ( AD ) , evidence is limited in mild to moderate AD .
OBJECTIVE	To determine if vitamin E ( alpha tocopherol ) , memantine , or both slow progression of mild to moderate AD in patients taking an acetylcholinesterase inhibitor .
METHODS	Double-blind , placebo-controlled , parallel-group , randomized clinical trial involving 613 patients with mild to moderate AD initiated in August 2007 and concluded in September 2012 at 14 Veterans Affairs medical centers .
METHODS	Participants received either 2000 IU/d of alpha tocopherol ( n = 152 ) , 20 mg/d of memantine ( n = 155 ) , the combination ( n = 154 ) , or placebo ( n = 152 ) .
METHODS	Alzheimer 's Disease Cooperative Study/Activities of Daily Living ( ADCS-ADL ) Inventory score ( range , 0-78 ) .
METHODS	Secondary outcomes included cognitive , neuropsychiatric , functional , and caregiver measures .
RESULTS	Data from 561 participants were analyzed ( alpha tocopherol = 140 , memantine = 142 , combination = 139 , placebo = 140 ) , with 52 excluded because of a lack of any follow-up data .
RESULTS	Over the mean ( SD ) follow-up of 2.27 ( 1.22 ) years , ADCS-ADL Inventory scores declined by 3.15 units ( 95 % CI , 0.92 to 5.39 ; adjusted P = .03 ) less in the alpha tocopherol group compared with the placebo group .
RESULTS	In the memantine group , these scores declined 1.98 units less ( 95 % CI , -0.24 to 4.20 ; adjusted P = .40 ) than the placebo group 's decline .
RESULTS	This change in the alpha tocopherol group translates into a delay in clinical progression of 19 % per year compared with placebo or a delay of approximately 6.2 months over the follow-up period .
RESULTS	Caregiver time increased least in the alpha tocopherol group .
RESULTS	All-cause mortality and safety analyses showed a difference only on the serious adverse event of `` infections or infestations , '' with greater frequencies in the memantine ( 31 events in 23 participants ) and combination groups ( 44 events in 31 participants ) compared with placebo ( 13 events in 11 participants ) .
CONCLUSIONS	Among patients with mild to moderate AD , 2000 IU/d of alpha tocopherol compared with placebo resulted in slower functional decline .
CONCLUSIONS	There were no significant differences in the groups receiving memantine alone or memantine plus alpha tocopherol .
CONCLUSIONS	These findings suggest benefit of alpha tocopherol in mild to moderate AD by slowing functional decline and decreasing caregiver burden .
BACKGROUND	clinicaltrials.gov Identifier : NCT00235716 .

###25033847
BACKGROUND	Cognitive dysfunction after subarachnoid hemorrhage ( SAH ) has been attributable to presence of subarachnoid blood , hydrocephalus ( HCP ) , cerebral edema , vasospasm , and temporary clipping of intracranial aneurysm .
BACKGROUND	Provision of neuroprotection during temporary clipping may improve postoperative cognition in such patients .
METHODS	Good-grade aneurysmal SAH patients undergoing temporary clipping during surgery were allocated either to group C ( control ) or group P ( propofol ) .
METHODS	Patients in group P received propofol in titrated doses to attain a burst suppression ratio of 75 5 % on bispectral index ( BIS ) monitor .
METHODS	The cognitive function as assessed by Hindi-language modification of mini-mental state examination ( HMSE ) score was evaluated preoperatively , 24 h after surgery , and at discharge from hospital .
METHODS	A score of 23 was indicative of cognitive dysfunction .
METHODS	Perioperative complications , duration of intensive care unit ( ICU ) and hospital stay , and outcome at discharge were noted .
RESULTS	A total of 66 patients ( 32 and 34 in group C and P respectively ) were included in the study .
RESULTS	97 % of the patients had anterior circulation aneurysms .
RESULTS	At 24 h after surgery , eight and 12 patients in group C and P respectively ; and at discharge , five patients in each group had cognitive dysfunction .
RESULTS	In both groups , the trend showed a decline in cognition at 24 h followed by improvement at discharge .
RESULTS	Glasgow outcome score in both the groups was comparable ( P > 0.05 ) .
RESULTS	Intraoperative brain bulge , postoperative vasospasm , and cerebral infarction were found to be independent risk factors for cognitive dysfunction .
CONCLUSIONS	Pharmacologic neuroprotection with propofol at the time of temporary clipping during surgery for aneurysmal SAH did not offer any advantage as far as preservation of cognition is concerned .

###25415733
OBJECTIVE	The purpose of this article is to assess the effect of the adaptive statistical iterative reconstruction ( ASIR ) technique on image quality in hip MDCT arthrography and to evaluate its potential for reducing radiation dose .
METHODS	Thirty-seven patients examined with hip MDCT arthrography were prospectively randomized into three different protocols : one with a regular dose ( volume CT dose index [ CTDIvol ] , 38.4 mGy ) and two with a reduced dose ( CTDIvol , 24.6 or 15.4 mGy ) .
METHODS	Images were reconstructed using filtered back projection ( FBP ) and four increasing percentages of ASIR ( 30 % , 50 % , 70 % , and 90 % ) .
METHODS	Image noise and contrast-to-noise ratio ( CNR ) were measured .
METHODS	Two musculoskeletal radiologists independently evaluated several anatomic structures and image quality parameters using a 4-point scale .
METHODS	They also jointly assessed acetabular labrum tears and articular cartilage lesions .
RESULTS	With decreasing radiation dose level , image noise statistically significantly increased ( p = 0.0009 ) and CNR statistically significantly decreased ( p = 0.001 ) .
RESULTS	We also found a statistically significant reduction in noise ( p = 0.0001 ) and increase in CNR ( p0 .003 ) with increasing percentage of ASIR ; in addition , we noted statistically significant increases in image quality scores for the labrum and cartilage , subchondral bone , overall diagnostic quality ( up to 50 % ASIR ) , and subjective noise ( p0 .04 ) , and statistically significant reductions for the trabecular bone and muscles ( p0 .03 ) .
RESULTS	Regardless of the radiation dose level , there were no statistically significant differences in the detection and characterization of labral tears ( n = 24 ; p = 1 ) and cartilage lesions ( n = 40 ; p0 .89 ) depending on the ASIR percentage .
CONCLUSIONS	The use of up to 50 % ASIR in hip MDCT arthrography helps to reduce radiation dose by approximately 35-60 % , while maintaining diagnostic image quality comparable to that of a regular-dose protocol using FBP .

###25074283
OBJECTIVE	The purpose of this study was to investigate the effects of different cold-water immersion ( CWI ) protocols on the inflammatory response to and functional recovery from high-intensity exercise .
METHODS	Eight healthy recreationally active males completed five trials of a high-intensity intermittent sprint protocol followed by a randomly assigned recovery condition : 1 of 4 CWI protocols ( CWI-10 min 20 C , CWI-30 min 20 C , CWI-10 min 10 C , or CWI-30 min 10 C ) versus passive rest .
METHODS	Circulating mediators of the inflammatory response were measured from EDTA plasma taken pre-exercise ( baseline ) , immediately post-exercise , and at 2 , 24 , and 48 h post-exercise .
METHODS	Ratings of perceived soreness and impairment were noted on a 10-pt Likert scale , and squat jump and drop jump were performed at these time points .
RESULTS	IL-6 , IL-8 , and MPO increased significantly from baseline immediately post-exercise in all conditions .
RESULTS	IL-6 remained elevated from baseline at 2 h in the CWI-30 min 20 C , CWI-10 min 10 C , and CWI-30 min 10 C conditions , while further increases were observed for IL-8 and MPO in the CWI-30 min 20 C and CWI-30 min 10 C conditions .
RESULTS	Squat jump and drop jump height were significantly lower in all conditions immediately post-exercise and at 2 h. Drop jump remained below baseline at 24 and 48 h in the CON and CWI-10 min 20 C conditions only , while squat jump height returned to baseline in all conditions .
CONCLUSIONS	Cold-water immersion appears to facilitate restoration of muscle performance in a stretch-shortening cycle , but not concentric power .
CONCLUSIONS	These changes do not appear to be related to inflammatory modulation .
CONCLUSIONS	CWI protocols of excessive duration may actually exacerbate the concentration of cytokines in circulation post-exercise ; however , the origin of the circulating cytokines is not necessarily skeletal muscle .

###25274428
OBJECTIVE	The objective of the study was to determine the relative bioavailability of an extended-release multilayer bead formulation of methylphenidate hydrochloride ( MPH-MLR ) 80mg vs. methylphenidate immediate-release ( IR ; Ritalin ( ) ) tablets as single and multiple doses in the fed state .
METHODS	A single-center , multiple-dose , randomized , open-label , two-period crossover study conducted in 26 healthy adults assigned to 4days of once-daily MPH-MLR 80mg or IR methylphenidate 25mg three times daily .
RESULTS	MPH-MLR 80mg produced reproducible biphasic profiles of plasma methylphenidate concentrations characterized by a rapid initial peak , followed by a moderate decline reaching a plateau ~ 5 h post dose , then a gradual increase culminating in an attenuated second peak ~ 7h post dose .
RESULTS	Maximum concentration was lower for MPH-MLR 80mg than IR methylphenidate 25mg three times daily on day 1 ( 23.70 vs. 31.47 ng/mL ) ; exposure was similar .
RESULTS	The geometric mean ratios ( MPH-MLR/IR methylphenidate [ 90 % CI ] ) of log-transformed area under the plasma drug concentration-time curve to the last measurable observation ( day 1 : 0.88 [ 84.75-91 .80 ] ; day 4 : 0.84 [ 81.16-86 .94 ] ) , and area under the plasma drug concentration extrapolated to infinity ( day 1 : 0.93 [ 88.57-97 .28 ] ; day 4 : 0.88 [ 84.48-91 .17 ] ) were within the 80-125 % bioequivalence range .
RESULTS	The meanSD MPH-MLR 80-mg capsule day 4 area under the plasma drug concentration vs. time curve from 0 to 4h ( 74.515.2 ngh/mL ) was greater than IR methylphenidate 25mg three times daily ( 66.017.4 ngh/mL ) , confirming steady-state levels during the study period .
RESULTS	All treatment regimens were safe and well tolerated .
CONCLUSIONS	MPH-MLR 80-mg capsule once daily or IR methylphenidate 25mg three times daily provides comparable maximum methylphenidate concentrations and systemic exposure in the fed state .

###24719492
BACKGROUND	Racial and gender disparities for smoking cessation might be accounted for by differences in expectancies for tobacco interventions , but few studies have investigated such differences or their relationships with motivation to quit and abstinence self-efficacy .
METHODS	In this cross-sectional study , 673 smokers ( African American : n = 443 , 65.8 % ; women : n = 222 , 33.0 % ) under criminal justice supervision who enrolled in a clinical smoking cessation trial in which all received bupropion and half received counseling .
METHODS	All participants completed pretreatment measures of expectancies for different tobacco interventions , motivation to quit , and abstinence self-efficacy .
METHODS	The indirect effects of race and gender on motivation to quit and abstinence self-efficacy through expectancies for different tobacco interventions were evaluated .
RESULTS	African Americans ' stronger expectancies that behavioral interventions would be effective accounted for their greater motivation to quit and abstinence self-efficacy .
RESULTS	Women 's stronger expectancies for the effectiveness of pharmacotherapy accounted for their greater motivation to quit , whereas their stronger expectancies for the effectiveness of behavioral treatments accounted for their greater abstinence self-efficacy .
CONCLUSIONS	Findings point to the mediating role of expectancies for treatment effectiveness and suggest the importance of exploring expectancies among African Americans and women as a way to augment motivation and self-efficacy .

###25414155
OBJECTIVE	GLP-1 receptor ( GLP-1R ) agonists induce natriuresis and reduce blood pressure ( BP ) through incompletely understood mechanisms .
OBJECTIVE	We examined the effects of acute and 21-day administration of liraglutide on plasma atrial natriuretic peptide ( ANP ) , urinary sodium excretion , office and 24-h BP , and heart rate ( HR ) .
METHODS	Liraglutide or placebo was administered for 3 weeks to hypertensive subjects with type 2 diabetes in a double-blinded , randomized , placebo-controlled crossover clinical trial in the ambulatory setting .
METHODS	End points included within-subject change from baseline in plasma ANP , Nt-proBNP , office BP , and HR at baseline and over 4 h following a single dose of liraglutide ( 0.6 mg ) and after 21 days of liraglutide ( titrated to 1.8 mg ) versus placebo administration .
METHODS	Simultaneous 24-h ambulatory BP and HR monitoring and 24-h urine collections were measured at baseline and following 21 days of treatment .
RESULTS	Plasma ANP levels did not change significantly after acute ( +16.72 pg/mL , P = 0.24 , 95 % CI [ -12.1 , +45.5 ] at 2 h ) or chronic ( -17.42 pg/mL , 95 % CI [ -36.0 , +1.21 ] at 2 h ) liraglutide administration .
RESULTS	Liraglutide significantly increased 24-h and nighttime urinary sodium excretion ; however , 24-h systolic BP was not significantly different .
RESULTS	Small but significant increases in 24-h and nighttime diastolic BP and HR were observed with liraglutide .
RESULTS	Body weight , HbA1c , and cholesterol were lower , and office-measured HR was transiently increased ( for up to 4 h ) with liraglutide administration .
CONCLUSIONS	Sustained liraglutide administration for 3 weeks increases urinary sodium excretion independent of changes in ANP or BP in overweight and obese hypertensive patients with type 2 diabetes .

###25753894
OBJECTIVE	To determine the ability of sheep to mobilise their body reserves after being deprived of feed prior to transport for slaughter .
METHODS	A total of 240 3 - and 4-year-old cull ewes were held off pasture for 0 , 9 , 18 or 30 hours ( n = 60 per group ) then transported 1 hour by road , unloaded and washed , held in lairage for 3 hours then slaughtered .
METHODS	Blood samples were collected from a subsample of 60 unfasted ewes 1 week earlier , and from all ewes at exsanguination to determine concentrations of serum metabolites indicative of adaptation to fasting .
METHODS	In addition , several attributes of carcass quality were measured .
RESULTS	At slaughter , increased time off pasture prior to transport resulted in no change in glucose concentrations in serum ( p = 0.140 ) .
RESULTS	There were differences ( p < 0.001 ) between the group fasted for 30 compared with 0 hours in mean concentrations of free fatty acids ( 0.98 ( SD 0.32 ) vs. 0.58 ( SD 0.23 ) mmol/L ) , - hydroxybutyrate ( 0.69 ( SD 0.17 ) vs. 0.42 ( SD 0.11 ) mmol/L ) , triglycerides ( 0.29 ( min 0.13 , max 0.83 ) vs. 0.22 ( min 0.06 , max 0.96 ) mmol/L ) and urea ( 10.17 ( SD 1.80 ) vs. 6.94 ( SD 2.03 ) mmol/L ) .
RESULTS	Different periods of feed deprivation had no effect ( p > 0.05 ) on carcass weights ( mean 22.7 , min 13.2 , max 32.9 kg ) or dressing out percentages ( mean 40.9 , min 27 , max 49 % ) .
RESULTS	Meat ultimate pH was unaffected ( p > 0.05 ) by the period of feed deprivation but meat became darker ( p < 0.05 ) and had reduced redness ( p < 0.001 ) with increasing time off feed .
CONCLUSIONS	The results suggest that sheep in variable body condition adapted to the periods of feed deprivation by mobilising their energy reserves without any evidence of metabolic depletion ( e.g. depleted blood glucose or high meat pH ) .
CONCLUSIONS	However , being deprived of feed they probably experience a degree of hunger .

###25256624
OBJECTIVE	Spectacle independence is becoming increasingly important in cataract surgery .
OBJECTIVE	Not correcting corneal astigmatism at the time of cataract surgery will fail to achieve spectacle independency in 20 % to 30 % of patients .
OBJECTIVE	To compare bilateral aspherical toric with bilateral aspherical control intraocular lens ( IOL ) implantation in patients with cataract and corneal astigmatism .
METHODS	A multicenter , hospital-based , randomized clinical trial was conducted .
METHODS	The participants included 86 individuals with bilateral cataract and bilateral corneal astigmatism of at least 1.25 diopters ( D ) who were randomized to receive either bilateral toric ( n = 41 ) or bilateral control ( n = 45 ) IOL implantation .
METHODS	Bilateral implantation of an aspherical toric IOL or an aspherical control IOL .
METHODS	Spectacle independency for distance vision , uncorrected distance visual acuity , refractive astigmatism , contrast sensitivity , wavefront aberrations , and refractive error-related quality-of-life questionnaire .
RESULTS	Preoperatively , mean ( SD ) corneal astigmatism was 2.02 ( 0.95 ) D and 2.00 ( 0.84 ) D in the toric and control groups , respectively .
RESULTS	Four patients ( 5 % ) were lost to follow-up .
RESULTS	At 6 months postoperatively , 26 ( 70 % ) of the patients in the toric group achieved an uncorrected distance visual acuity of 20/25 or better compared with 14 ( 31 % ) in the control group ( P < .001 ; odds ratio , 5.23 ; 95 % CI , 2.03-13 .48 ) .
RESULTS	Spectacle independency for distance vision was achieved in 31 patients ( 84 % ) in the toric group compared with 14 patients ( 31 % ) in the control group ( P < .001 ; odds ratio , 11.44 ; 95 % CI , 3.89 - 33.63 ) .
RESULTS	Mean refractive astigmatism was -0.77 ( 0.52 ) D and -1.89 D ( 1.00 ) D , respectively .
RESULTS	Vector analysis of toric IOLs showed a mean magnitude of error of +0.38 D , indicative of overcorrection .
RESULTS	No significant differences were found in contrast sensitivity , higher-order aberrations , or refractive error-related quality of life .
CONCLUSIONS	In patients with cataract and corneal astigmatism , bilateral toric IOL implantation results in a higher spectacle independency for distance vision compared with bilateral control IOL implantation .
CONCLUSIONS	No significant differences were identified in contrast sensitivity , higher-order aberrations , or refractive error-related quality of life following both treatments .
BACKGROUND	clinicaltrials.gov Identifier : NCT01075542 .

###25197997
OBJECTIVE	This study 's purpose was to evaluate the success of calcium hydroxide ( CH ) and mineral trioxide aggregate ( MTA ) pulpotomies following the use of five percent sodium hypochlorite ( NaOCl ) as an antibacterial agent to clean the chamber prior to application of the pulpotomy agent .
METHODS	A total of 128 teeth were randomly divided into two pulpotomy groups ( CH or MTA ) .
METHODS	The teeth in each pulpotomy group , CH and MTA , were further randomly divided into subgroups to receive either the NaOCl ( experimental ) or saline ( control ) cleaning agent prior to applying the pulpotomy agent .
METHODS	The treatments were followed clinically and radiographically for 12 months .
RESULTS	The radiographic success rates were 84 percent for CH NaOCl , 74 percent for CH saline control , 97 percent for MTA NaOCl , and 100 percent for MTA saline control .
RESULTS	There were no significant differences between the radiographic success rates in the CH and MTA subgroups ( CH NaOCl-CH control and MTA NaOCl-MTA control ) ; no significant differences were observed when comparing the CH NaOCl-MTA NaOCl groups and the CH NaOCl-MTA control groups .
CONCLUSIONS	Use of sodium hypochlorite as an antibacterial agent prior to application of the pulpotomy agent improved the success of calcium hydroxide pulpotomies to equal the success of mineral trioxide aggregate pulpotomies for observation up to 12 months .

###24531083
OBJECTIVE	A treatment strategy to inhibit nonsteroidal anti-inflammatory drug ( NSAID ) - induced small intestinal lesions has not yet been established .
OBJECTIVE	To clarify whether monotherapy with a gastromucoprotective drug , geranylgeranylacetone ( GGA ) , inhibits NSAID-induced acute mucosal injury of the upper digestive tract and small intestine .
METHODS	A prospective , randomized , comparative study .
METHODS	All procedures were performed at Osaka Medical College .
METHODS	The subjects , thirty healthy adult volunteers , were randomly divided into two groups .
METHODS	In the NSAID-GGA group , 75 mg/day of diclofenac sodium and 150 mg/day of GGA were orally administered for two weeks .
METHODS	In the NSAID-FAM group , 75 mg/day of diclofenac sodium and 20 mg/day of famotidine ( FAM ) were orally administered for two weeks .
METHODS	esophagogastroduodenoscopy ( EGD ) and video capsule endoscopy ( VCE ) were performed before and two weeks after drug administration .
METHODS	In addition , we measured fecal occult blood reactions and the fecal calprotectin levels .
RESULTS	No significant differences were observed between the groups in the mean increase in esophageal/gastroduodenal lesions .
RESULTS	The mean increases in the scores in the NSAID-FAM group ( NSAID-GGA group ) of small bowel lesions were as follows : erythema : 1.93 0.67 ( 0.30 0.60 ) , erosions : 1.13 0.54 ( 0.38 0.35 ) , ulcers : 0.73 0.33 ( 0.07 0.07 ) and edema : 0.53 0.44 ( 0.07 0.07 ) .
RESULTS	The scores for erythema and ulcers were significantly lower in the NSAID-GGA group than in the NSAID-FAM group ( p = 0.032 and 0.0165 , respectively ) .
CONCLUSIONS	We compared the prophylactic effects of a mucoprotective drug , GGA , and an H2RA , famotidine , on mucosal injury involving the esophagus to the small intestine related to the two-week oral administration of diclofenac sodium in healthy volunteers .
CONCLUSIONS	In the upper digestive tract , the prophylactic effects were similar between the two drugs .
CONCLUSIONS	However , in the small intestine , GGA more markedly inhibited the development of lesions compared to famotidine .

###25442152
BACKGROUND	A small number of studies conducted to date have suggested that transcranial direct current stimulation ( tDCS ) applied to the temporoparietal cortex may reduce auditory hallucinations in patients with schizophrenia .
BACKGROUND	Prefrontal brain stimulation with other methods , has also been shown to potentially improve the negative symptoms of this disorder .
OBJECTIVE	To investigate the therapeutic potential of daily bimodal tDCS : anodal stimulation to the prefrontal cortex and cathodal stimulation to the temporoparietal junction in patients with persistent hallucinations and negative symptoms of schizophrenia .
METHODS	We conducted two small randomized double-blind controlled trials comparing bimodal tDCS to sham stimulation .
METHODS	In one study , stimulation was provided unilaterally , in the second study it was provided bilaterally .
RESULTS	Neither unilateral nor bilateral tDCS resulted in a substantial change in either hallucinations or negative symptoms .
RESULTS	Stimulation was well tolerated without side-effects .
CONCLUSIONS	Daily tDCS does not appear to have substantial potential in the treatment of hallucinations or negative symptoms and further research should investigate higher doses of stimulation or more frequently applied treatment schedules .

###25153050
BACKGROUND	An emergency department ( ED ) visit may be an effective place to screen and educate families about injury prevention .
BACKGROUND	The purpose of this study was to determine if a computerized kiosk in a pediatric ED can screen families for injury risk and encourage them to make more safety changes at follow-up survey compared with an injury prevention specialist ( IPS ) .
METHODS	A prospective , randomized controlled study was performed with families of children younger than 14 years in an ED lobby .
METHODS	Families were screened for injury risk by computerized kiosk based on child 's age category at triage ( birth to 1 year , 1-4 years , 5-9 years , or 10-14 years ) .
METHODS	Families were randomized to receive either injury behavior instructions by kiosk printout or by IPS when answers to specific practices were deemed unsafe .
METHODS	Three weeks after intervention , families were telephoned to determine change in safety practices .
RESULTS	Three hundred seventeen families completed ED kiosk screen at enrollment ( 172 kiosk , 145 IPS ) .
RESULTS	On initial screen , kiosk families practiced 79.6 % of behaviors safely versus 75.9 % in the IPS group ( p = 0.011 ) .
RESULTS	A total of 221 families ( 69.7 % ) were reached for follow-up ( 121 kiosk , 100 IPS ) .
RESULTS	On average , IPS families improved their safe behavior responses by 8.3 % versus 1.0 % in the kiosk group ( p < 0.0001 ) .
RESULTS	Significantly more families in the IPS group than in the kiosk group ( 36 % vs. 23 % , p < 0.03 ) used additional safety equipment after the intervention .
CONCLUSIONS	A computerized kiosk based in a pediatric ED can help screen families for their injury risk .
CONCLUSIONS	However , to elicit significant behavior change , an IPS discussing safety changes may be more effective .

###24881610
OBJECTIVE	To compare the efficacy of postoperative topical nepafenac ( 0.1 % ) with prednisolone acetate ( 1 % ) as anti-inflammatory agents in eyes undergoing Transscleral Sutureless Vitrectomy ( TSV ) .
METHODS	Prospective , double-blind , randomized , single center clinical study .
METHODS	Eighty eyes of 76 subjects , who underwent small gauge vitrectomy , were included in the study .
METHODS	The subjects who fulfilled the inclusion criteria were randomized to either topical nepafenac only ( Group 1 ) or prednisolone acetate only ( Group 2 ) , to be used as postoperative anti-inflammatory agents .
METHODS	The subjects were reviewed on days 1 , 30 , and 90 .
METHODS	Ocular and adnexal inflammation was appropriately graded using the standardized classification .
METHODS	Grading of ocular pain was done on the Visual Analog Scale ( VAS ) .
METHODS	The Wilcoxon rank-sum test , using two-sided analysis , was used .
RESULTS	During the follow-up , both Group 1 and Group 2 did not have a significant difference related to the grade of the anterior chamber inflammation ( P > 0.05 ) or adnexal inflammation ( P > 0.05 ) .
RESULTS	Pain perception was less in the subjects in Group 1 as compared to subjects in Group 2 , but was not statistically significant ( P > 0.05 ) .
CONCLUSIONS	Postoperative topical nepafenac was non-inferior to prednisolone acetate in reducing postoperative ocular inflammation in eyes undergoing TSV .

###24462483
OBJECTIVE	Environmental enteropathy ( EE ) is a subclinical condition among children in the developing world , characterized by T-cell infiltration of the small-bowel mucosa and diffuse villous atrophy .
OBJECTIVE	EE leads to macronutrient and micronutrient malabsorption and stunting , with a resultant increased risk for infection and reduced cognitive development .
OBJECTIVE	We tested the hypothesis that zinc and albendazole treatments would reduce the severity of EE in rural African children .
METHODS	In a randomized , double-blind , placebo-controlled trial in rural southern Malawi , asymptomatic children , 1 to 3 years old and at high risk for EE , received either a single dose of albendazole , a 14-day course of 20 mg zinc sulfate , or a placebo .
METHODS	Subjects were given the dual-sugar absorption test , and the ratio of lactulose to mannitol ( L : M ) in urine was used to determine the severity of EE at baseline and 34 days after completion of the assigned regimen .
METHODS	The primary outcome was the change in the L : M.
RESULTS	A complete set of urine samples was obtained from 222 of 234 children enrolled and analyzed .
RESULTS	The mean baseline L : M was 0.32 0.18 among all children and did not differ among groups ( normal L : M range , < 0.12 ) .
RESULTS	At the end of the study , the L : M ratio had increased more in the placebo group ( 0.12 0.31 ) than in the zinc group ( 0.03 0.20 ; P < .03 ) or the albendazole group ( 0.04 0.22 ; P < .04 ) .
CONCLUSIONS	Treatment with zinc or albendazole protects against a significant increase in the L : M ratio , a biomarker for EE , in asymptomatic rural Malawian children .
CONCLUSIONS	These findings could provide insight into the etiology and pathogenesis of EE .
CONCLUSIONS	Clinicaltrials.gov Number : NCT01440608 .

###24269077
OBJECTIVE	Cancer-related malnutrition is multifactorial and related to a bad prognosis .
OBJECTIVE	The aim of this study was to investigate the effect of intensive , individual dietary counseling of patients in radiotherapy and/or chemotherapy for gynecologic - , gastric - , or esophageal cancer .
METHODS	61 outpatients were stratified by diagnoses and randomly assigned to one of two groups ( G1 ; n = 32 and G2 ; n = 29 ) .
METHODS	The basic regimen , applied to both groups , included measurement of body weight , 24-h dietary recall interview , micronutrient status and quality of life .
METHODS	In addition G1 received intensive , individual dietary counseling one hour per week and , if the patient accepted , a daily oral nutritional supplement containing 2531 kJ , 33.8 g protein and 2.2 g EPA .
RESULTS	At the end of the treatment period , significantly fewer patients had lost weight in the intervention group ( mean : 44 % vs. 72 % , p < 0.05 ) , and the fulfillment of estimated energy requirements was better during treatment ( mean : 107 % vs. 95 % , p < 0.05 ) .
RESULTS	A significant positive effect was observed on the fulfillment of protein requirement , both during the treatment period ( mean : 92 % vs. 71 % , p < 0.001 ) and at follow-up ( mean : 86 % vs. 71 % , p < 0.05 ) .
CONCLUSIONS	In these cancer patients , intensive , individual dietary counseling was associated with a better weight maintenance and a higher provision of adequate amounts of protein and energy .
CONCLUSIONS	The intervention had no significant effects on patients ' quality of life , incidence of treatment-related side effects or appearance of micronutrient deficiencies .

###24748218
BACKGROUND	Chronic inflammation is hypothesized to influence prostate cancer development , although a definitive link has not been established .
METHODS	Prostate cancer cases ( N = 191 ) detected on a for-cause ( clinically indicated ) or end-of-study ( protocol directed ) biopsy , and frequency-matched controls ( N = 209 ) , defined as negative for cancer on an end-of-study biopsy , were sampled from the placebo arm of the Prostate Cancer Prevention Trial .
METHODS	Inflammation prevalence and extent in benign areas of biopsy cores were visually assessed using digital images of hematoxylin and eosin-stained sections .
METHODS	Logistic regression was used to estimate associations .
RESULTS	Of note , 86.2 % of cases and 78.2 % of controls had at least one biopsy core ( of three assessed ) with inflammation in benign areas , most of which was chronic .
RESULTS	Men who had at least one biopsy core with inflammation had 1.78 [ 95 % confidence interval ( CI ) , 1.04-3 .06 ] times the odds of prostate cancer compared with men who had zero cores with inflammation .
RESULTS	The association was stronger for high-grade disease ( Gleason sum 7-10 , N = 94 ; OR , 2.24 ; 95 % CI , 1.06-4 .71 ) .
RESULTS	These patterns were present when restricting to cases and controls in whom intraprostatic inflammation was the least likely to have influenced biopsy recommendation because their prostate-specific antigen ( PSA ) was low ( < 2 ng/mL at biopsy ) .
CONCLUSIONS	Inflammation , most of which was chronic , was common in benign prostate tissue , and was positively associated with prostate cancer , especially high grade .
CONCLUSIONS	The association did not seem to be due to detection bias .
CONCLUSIONS	This study supports an etiologic link between inflammation and prostate carcinogenesis , and suggests an avenue for prevention by mitigating intraprostatic inflammation .

###25997550
OBJECTIVE	The aims of this study were to establish a bioanalytical method and to evaluate the bioequivalence of two drug products ; a generic sildenafil 50 mg film-coated vs. the brand drug Viagra 50 mg film-coated tablets .
METHODS	Bioequivalence of tablets was tested by comparisons against the reference brand product in accordance with the requirements of the Declaration of Helsinki , the current Good Clinical Practice ( GCP ) Guidelines and the International Conference Harmonization ( ICH ) .
RESULTS	The relationship between concentration and peak area ratio was found to be linear within the range of 1.435 - 410.023 ng/mL for sildenafil .
RESULTS	The correlation coefficient ( r ) was always greater than 0.99 during the course of the validation Statistical comparison of the main pharmacokinetic parameters showed no significant difference between test and reference .
RESULTS	The 90 % CIs of geometric mean ratios ( test to reference ratios ) were 99.656 % , 99.806 % , and 109.227 % for AUC ( 0-last ) , AUC ( 0 - ) , and C ( max ) , respectively .
RESULTS	These pharmacokinetic parameter values lie within the FDA and European Medicines Agency specified bioequivalence limit ( 80 - 125 % ) .
RESULTS	Both formulations were well tolerated by all subjects and they were discharged in good health .
CONCLUSIONS	The tested drug product was bioequivalent to the reference drug and had the same safety profile .

###24970773
BACKGROUND	Functional neuroimaging studies implicate anterior cingulate and limbic dysfunction in major depressive disorder ( MDD ) and responsiveness to antidepressants .
BACKGROUND	Diffusion tensor imaging ( DTI ) enables characterisation of white matter tracts that relate to these regions .
OBJECTIVE	To examine whether DTI measures of anterior cingulate and limbic white matter are useful prognostic biomarkers for MDD .
METHODS	Of the 102 MDD out-patients from the International Study to Predict Optimized Treatment for Depression ( iSPOT-D ) who provided baseline magnetic resonance imaging ( MRI ) data , 74 completed an 8-week course of antidepressant medication ( randomised to escitalopram , sertraline or extended-release venlafaxine ) and were included in the present analyses .
METHODS	Thirty-four matched controls also provided DTI data .
METHODS	Fractional anisotropy was measured for five anterior cingulate-limbic white matter tracts : cingulum cingulate and hippocampus bundle , fornix , stria terminalis and uncinate fasciculus .
METHODS	( Trial registered at ClinicalTrials.gov : NCT00693849 . )
RESULTS	A cross-validated logistic regression model demonstrated that altered connectivity for the cingulum part of the cingulate and stria terminalis tracts significantly predicted remission independent of demographic and clinical measures with 62 % accuracy .
RESULTS	Prediction improved to 74 % when age was added to this model .
CONCLUSIONS	Anterior cingulate-limbic white matter is a useful predictor of antidepressant treatment outcome in MDD .

###25090264
OBJECTIVE	Type 2 diabetes is known to be associated with increasing cardiovascular mortality .
OBJECTIVE	Malondialdehyde-modified LDL ( MDA-LDL ) is an oxidized LDL and is increased in patients with diabetes or hypertriglyceridemia .
OBJECTIVE	Elevated MDA-LDL has been reported to be a risk factor of atherosclerosis or cardiovascular disease .
OBJECTIVE	Sitagliptin is a dipeptidyl peptidase-4 inhibitor and a new class of hypoglycemic agents .
OBJECTIVE	In this study , the effects of increasing the dose of metformin and add-on sitagliptin on MDA-LDL were examined in type 2 diabetes patients .
METHODS	Seventy patients with type 2 diabetes , inadequately controlled despite on-going treatment with metformin 500 mg/day , were enrolled in this randomized controlled trial .
METHODS	The patients received additional metformin ( 500 mg/day ) or sitagliptin ( 50 mg/day ) for 6 months , and changes in metabolic parameters including MDA-LDL were evaluated .
RESULTS	After 6 months of treatment , add-on sitagliptin ( n = 35 ) improved fasting blood glucose ( FBG ) and hemoglobin A1c ( HbA1c ) to significantly greater extent than increasing the dose of metformin ( n = 35 ) .
RESULTS	There were no differences in total cholesterol and low-density lipoprotein cholesterol levels between two groups .
RESULTS	MDA-LDL levels ( mean S.E. ) decreased significantly with increasing the dose of metformin ( from 94.40 6.35 to 77.83 4.74 U/L , P < 0.005 ) , but remained unchanged with add-on sitagliptin treatment ( from 89.94 5.59 to 98.46 6.78 U/L , p > 0.05 ) .
RESULTS	Multiple linear regression analysis identified increasing the dose of metformin treatment as the only independent factor associated with decreased MDA-LDL ( coefficient 0.367 , P < 0.0119 ) , and no significant correlation between change in MDA-LDL and fasting blood glucose or HbA1c .
CONCLUSIONS	These results suggest that increasing the dose of metformin improves serum MDA-LDL levels in type 2 diabetes mellitus .

###25549907
OBJECTIVE	This study was designed to test the effect of the featured/featureless nature of deviant stimuli on mismatch negativity ( MMN ) , P300 ( P3a and P3b ) and on behavioral discrimination performances .
METHODS	Ten healthy adults were submitted to stimuli contrasted by the presence or absence of a frequency sweep .
METHODS	Discrimination performances were collected during the neurophysiological sessions .
RESULTS	MMN , P3a and P3b were much larger for featured deviants than for featureless ones .
RESULTS	Behavioral data ( d' , at ceiling level , and reaction times ) were not affected by the featured/featureless nature of the deviant stimulus .
CONCLUSIONS	Behavioral results and MMN amplitudes are in accordance with our previous study , using the same design albeit in an ignore condition and with collection of the behavioral data deferred until after the neurophysiological sessions .
CONCLUSIONS	The present study strengthens previous evidence suggesting that two mechanisms contribute to the MMN evoked by featured deviants : the memory comparison process and the adaptation/fresh-afferent phenomenons .
CONCLUSIONS	We here demonstrate that the neurophysiological processes underlying P300 generation are also impacted by the featured/featureless nature of the deviant stimulus and that the dissociation from behavioral data , which are not impacted , is also observed when both types of data are recorded simultaneously .

###26031737
OBJECTIVE	To evaluate the effect of an innovative model integrating telemonitoring of vital parameters and telephone support on 6-month survival and hospital admissions of elderly adults with heart failure ( HF ) .
METHODS	Parallel-arm , randomized trial .
METHODS	Geriatric acute care ward and outpatient clinic at Policlinico Campus Biomedico ( Rome , Italy ) .
METHODS	Individuals with HF aged 65 and older ( mean age 80 ) randomly assigned to intervention ( n = 50 ) or control ( n = 46 ) .
METHODS	Participants had an average ejection fraction of 46 % .
METHODS	Telemonitoring system ( receives and communicates oxygen saturation , heart rate , and blood pressure readings ) and office-hours telephonic support provided by a geriatrician .
METHODS	Combination of all-cause death and hospital admissions .
RESULTS	The two groups were similar with the exception of the prevalence of women and of disability ( both more common in the control group ) .
RESULTS	Three patients for each group were lost to follow-up ( final analyzed sample size : 90 ) .
RESULTS	Incidence of the main outcome was 42 % in the control group and 21 % in the intervention group ( relative risk = 0.51 , 95 % confidence interval ( CI ) = 0.26-0 .98 ) .
RESULTS	The results were unchanged after taking into account the setting of enrollment , sex , and disability ( hazard ratio = 0.42 , 95 % CI = 0.19-0 .94 ) .
CONCLUSIONS	Telemonitoring of elderly people with HF is feasible and reduces the risk of death and hospitalization .
CONCLUSIONS	Further studies are needed to confirm these findings and evaluate the cost-efficacy of the service .

###24413548
BACKGROUND	Postoperative delirium in the intensive care unit ( ICU ) is a frequent complication after cardiac or thoracic surgery and is associated with increased morbidity and mortality .
METHODS	In this single-center substudy of the BAG-RECALL trial ( NCT00682825 ) , we screened patients after cardiac or thoracic surgery in the ICU twice daily for delirium using the Confusion Assessment Method for the ICU .
METHODS	The primary outcome was the incidence of delirium in patients who had been randomized to intraoperative Bispectral Index ( BIS ) - guided and end-tidal anesthetic concentration-guided depth of anesthesia protocols .
METHODS	As a secondary analysis , a Bayesian stochastic search variable selection strategy was used to rank a field of candidate risk factors for delirium , followed by binary logistic regression .
RESULTS	Of 310 patients assessed , 28 of 149 ( 18.8 % ) in the BIS group and 45 of 161 ( 28.0 % ) in the end-tidal anesthetic concentration group developed postoperative delirium in the ICU ( odds ratio 0.60 , 95 % confidence interval , 0.35-1 .02 , P = 0.058 ) .
RESULTS	Low average volatile anesthetic dose , intraoperative transfusion , ASA physical status , and European System for Cardiac Operative Risk Evaluation were identified as independent predictors of delirium .
CONCLUSIONS	A larger randomized study should determine whether brain monitoring with BIS or an alternative method decreases delirium after cardiac or thoracic surgery .
CONCLUSIONS	The association between low anesthetic concentration and delirium is a surprising finding and could reflect that patients with poor health are both more sensitive to the effects of volatile anesthetic drugs and are also more likely to develop postoperative delirium .
CONCLUSIONS	Investigation of candidate methods to prevent delirium should be prioritized in view of the established association between postoperative delirium and adverse patient outcomes .

###24249435
BACKGROUND	Angiogenesis contributes to the progression of urothelial carcinoma ( UC ) .
BACKGROUND	In the current study , the authors investigated the role of maintenance sunitinib in patients with advanced UC .
METHODS	Patients with locally recurrent/metastatic UC and adequate organ function who achieved stable disease or a partial or complete response after 4 to 6 chemotherapy cycles were randomized to sunitinib at a dose of 50 mg/day ( 28 days on and 14 days off ) or placebo .
METHODS	The primary endpoint was the 6-month progression rate .
METHODS	Secondary endpoints were safety , survival , change in serum vascular endothelial growth factor ( VEGF ) / soluble VEGF receptor-2 ( sVEGFR2 ) , and the activity of sunitinib in patients who developed disease progression while receiving placebo .
METHODS	A total of 38 eligible patients per treatment arm were required to select better therapy with 90 % probability ( = .05 ) .
RESULTS	A total of 54 eligible patients were randomized to either the sunitinib arm ( 26 patients ) or the placebo arm ( 28 patients ) .
RESULTS	The median number of cycles received was 2 cycles per treatment arm .
RESULTS	The most common grade 3 to 4 adverse events ( graded according to version 3.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events ) among patients receiving sunitinib were thrombocytopenia , diarrhea , mucositis , fatigue , and hypertension .
RESULTS	There were no grade 3 or 4 adverse events noted among > 5 % of patients receiving placebo .
RESULTS	The 6-month progression rate was 72 % versus 64 % .
RESULTS	The median progression-free survival ( PFS ) was 2.9 months ( range , 0.5 months-32 .5 months ) versus 2.7 months ( range , 0.8 months -65 months ) for the sunitinib versus placebo arms , respectively .
RESULTS	Patients receiving placebo were found to have no changes in their serum VEGF/sVEGFR2 levels over time .
RESULTS	Patients treated with sunitinib had no significant change in their VEGF level , but the sVEGFR2 level significantly decreased after cycles 1 and 2 ( P < .0001 ) and at the time of disease progression ( P = .0002 ) .
RESULTS	A baseline VEGF level that was at or greater than the median was found to be correlated with a longer PFS .
RESULTS	Sixteen patients who were receiving placebo received sunitinib at the time of disease progression , with the best responses being 1 partial response ( 6.3 % ) , 6 cases of stable disease ( 37.5 % ) , and 5 cases of progressive disease ( 31.3 % ) ; 4 patients were not evaluable for response .
RESULTS	The median PFS was 3.7 months ( range , 0.1 months-22 months ) .
CONCLUSIONS	The current multicenter study was limited by premature closure and a small sample size .
CONCLUSIONS	Maintenance sunitinib did not appear to improve the 6-month progression rate .
CONCLUSIONS	Open-label sunitinib was found to have only modest activity .
CONCLUSIONS	The sVEGFR2 level decreased among patients receiving sunitinib .

###24885729
BACKGROUND	Families with low incomes experience an array of health and social challenges that compromise their resilience and lead to negative family outcomes .
BACKGROUND	Along with financial constraints , there are barriers associated with mental and physical health , poorer education and language .
BACKGROUND	In addition , vulnerable populations experience many services as markedly unhelpful .
BACKGROUND	This combination of family and service barriers results in reduced opportunities for effective , primary-level services and an increased use of more expensive secondary-level services ( e.g. , emergency room visits , child apprehensions , police involvement ) .
BACKGROUND	A systematic review of effective interventions demonstrated that promotion of physical and mental health using existing service was critically important .
METHODS	The Families First Edmonton Trial ( FFE ) tests four service integration approaches to increase use of available health and social services for families with low-income .
METHODS	It is a randomized , two-factor , single-blind , longitudinal effectiveness trial where low-income families ( 1168 ) were randomly assigned to receive either ( 1 ) Family Healthy Lifestyle plus Family Recreation service integration ( Comprehensive ) , ( 2 ) Family Healthy Lifestyle service integration , ( 3 ) Family Recreation service integration , or ( 4 ) existing services .
METHODS	To be eligible families needed to be receiving one of five government income assistance programs .
METHODS	The trial was conducted in the City of Edmonton between January 2006 and August 2011 .
METHODS	The families were followed for a total of three years of which interventional services were received for between 18 and 24 months .
METHODS	The primary outcome is the number of family linkages to health and social services as measured by a customized survey tool `` Family Services Inventory '' .
METHODS	Secondary outcomes include type and satisfaction with services , cost of services , family member health , and family functioning .
METHODS	Where possible , the measures for secondary outcomes were selected because of their standardization , the presence of published norming data , and their utility as comparators to other studies of low-income families .
METHODS	As an effectiveness trial , community and government partners participated in all committees through a mutually agreed upon governance model and helped manage and problem solve with researchers .
CONCLUSIONS	Modifications were made to the FFE trial based on the pragmatics of community-based trials .
BACKGROUND	ClinicalTrials.gov NCT00705328 .

###24692735
OBJECTIVE	To determine the treatment outcome of combined androgen blockade ( CAB ) therapy using the non-steroidal antiandrogen bicalutamide or the steroidal antiandrogen chlormadinone in patients with prostate cancer .
METHODS	In total , 124 patients with prostate cancer enrolled in the present study were randomized to receive CAB therapy using a gonadotropin-releasing hormone ( GnRH ) agonist , combined with bicalutamide or chlormadinone .
METHODS	The survival of patients was analyzed .
RESULTS	The 5-year cancer-specific survival for the bicalutamide - and chlormadinone-treated groups were 91.7 % and 86.6 % , respectively , with no significant difference ( p = 0.39 ) .
RESULTS	Five-year overall survival was significantly ( p = 0.029 ) better in the bicalutamide-treated group .
RESULTS	Moreover , M1 patients in the chlormadinone group had significantly lower cancer-specific and overall survival compared to those in the bicalutamide-treated group .
RESULTS	However , in the case of M0 patients , no significant difference in cancer-specific nor in overall survival was observed .
CONCLUSIONS	CAB therapy using chlormadinone led to a significantly poorer survival outcome versus the use of bicalutamide .
CONCLUSIONS	However , because this survival trend was not observed in M0 cases , chlormadinone may still be an option for CAB therapy , depending on clinical stage and the severity of adverse effects , such as hot flashes .

###24776962
OBJECTIVE	Iodine deficiency is one of the most important causes of congenital hypothyroidism .
OBJECTIVE	In addition to thyroid hormone replacement , iodine supplementation is also given to newborns with congenital hypothyroidism due to iodine deficiency .
OBJECTIVE	We aimed to determine whether it is beneficial to administer iodine supplementation in addition to the L-thyroxine ( L-T4 ) treatment of newborns with congenital hypothyroidism due to iodine deficiency .
METHODS	Of 51 newborns , 26 who were diagnosed with congenital hypothyroidism due to iodine deficiency were treated with L-T4 .
METHODS	The remaining 25 cases were given L-T4 plus 100 g/day of oral iodine .
METHODS	Free triiodothyronine ( fT3 ) , free thyroxine ( fT4 ) , thyroid-stimulating hormone ( TSH ) , thyroglobulin ( TG ) , thyroid volume , urine iodine and breast milk iodine levels were measured in the first and third months of treatment , and the data were compared between the two groups .
RESULTS	First - and third-month values of fT3 , fT4 , TSH , TG and thyroid volume for both groups were statistically similar .
RESULTS	There was no significant difference between the two groups in respect to falling levels of fT3 and TSH , the rate of increase of fT4 levels or the shrinkage rate of thyroid volume .
CONCLUSIONS	In this study , the addition of oral iodine to L-T4 treatment provided no benefit compared to treatment with L-T4 alone .

###25288512
BACKGROUND	Cannabis users often claim that cannabis has the potential to enhance their creativity .
BACKGROUND	Research suggests that aspects of creative performance might be improved when intoxicated with cannabis ; however , the evidence is not conclusive .
OBJECTIVE	The aim of this study was to investigate the acute effects of cannabis on creativity .
METHODS	We examined the effects of administering a low ( 5.5 mg delta-9-tetrahydrocannabinol [ THC ] ) or high ( 22 mg THC ) dose of vaporized cannabis vs. placebo on creativity tasks tapping into divergent ( Alternate Uses Task ) and convergent ( Remote Associates Task ) thinking , in a population of regular cannabis users .
METHODS	The study used a randomized , double-blind , between-groups design .
RESULTS	Participants in the high-dose group ( n = 18 ) displayed significantly worse performance on the divergent thinking task , compared to individuals in both the low-dose ( n = 18 ) and placebo ( n = 18 ) groups .
CONCLUSIONS	The findings suggest that cannabis with low potency does not have any impact on creativity , while highly potent cannabis actually impairs divergent thinking .

###25428511
BACKGROUND	Currently , there is a debate whether the laparoscopic gastric imbrication ( LGI ) offers similar weight loss when compared to the laparoscopic sleeve gastrectomy ( LSG ) .
BACKGROUND	On the surface , they seem to offer similar-sized stomachs after the procedures are performed .
BACKGROUND	We chose to perform a randomized double-blinded trial to see if similar-sized pouches result in similar types of weight loss .
BACKGROUND	Our belief was that sleeve gastrectomy would offer at least a 10 % better weight loss over a 3-year period .
METHODS	Thirty patients were randomized to one of two arms .
METHODS	The patients and the third party administrator following the patients were blinded as to which procedure was chosen .
METHODS	The surgeon had full knowledge of the patients ' surgery throughout the treatment .
METHODS	The decision of which arm to place them was made by a single employee of the third party administrator and not shared with the employees following the patients .
METHODS	Patients were then followed for 3 years .
RESULTS	There were no differences in weight , age , or BMI preoperatively .
RESULTS	There were no differences between the two groups at any follow-up time point from 6 months to 3 years .
RESULTS	Follow-up was 100 % .
CONCLUSIONS	Due to the large standard deviations present in both groups , there was no statistical difference between either of the groups in terms of weight loss .

###25816050
BACKGROUND	The objective of the study was to examine post hoc associations between plasma sphingolipids and lipoprotein kinetics in men with the metabolic syndrome after rosuvastatin treatment .
METHODS	Plasma sphingolipid profiling , determined by tandem mass spectrometry , was performed in a randomized , double-blind , triple-crossover trial ( n = 12 ) of 5-week treatment periods with placebo or rosuvastatin ( 10 or 40 mg/d ) with 2-week washouts between treatments .
CONCLUSIONS	Baseline plasma ceramides were associated with very low-density lipoprotein ( VLDL ) apolipoprotein ( apo ) - B-100 concentration ( r = 0.58 , P < .05 ) and inversely with VLDL apoB-100 fractional catabolic rate ( FCR ; r = -0.67 , P = .02 ) .
CONCLUSIONS	Posttreatment changes with rosuvastatin ( 40 mg/d ) in plasma ceramides were inversely associated with VLDL apoB-100 FCR ( r = -0.62 , P = .03 ) independent of changes in plasma triglycerides , cholesterol , and low-density lipoprotein-cholesterol .
CONCLUSIONS	By contrast , baseline and postrosuvastatin treatment plasma sphingomyelin levels were not associated with apoB-100 kinetics .
CONCLUSIONS	Plasma ceramides and sphingomyelin were not associated with the kinetics or concentrations of high-density lipoprotein apoA-I , and low-density lipoprotein apoB .
CONCLUSIONS	In the metabolic syndrome , the ability of rosuvastatin to increase VLDL apoB-100 FCR may reflect ceramide-specific mechanistic actions and/or sphingolipid exchange .

###24752608
OBJECTIVE	Laser hair removal has become an increasingly popular method to remove unwanted or excessive hair .
OBJECTIVE	We have assessed the relative efficacy and discomfort associated with competing hair removal techniques , namely a high average power 810nm diode laser using an in-motion technique with a market-leading 810nm device with a single-pass vacuum-assisted technique .
OBJECTIVE	This study has determined the long-term ( 6-12 months ) hair reduction efficacy and the relative pain induction intensities of these devices .
METHODS	Prospective , randomized , side-by-side comparison of either the legs or axillae was performed comparing the Soprano XL 810nm diode in super hair removal ( SHR ) mode ( Alma Lasers , Buffalo Grove , IL ) hereafter known as the in-motion device vs. the LightSheer Duet 810nm diode laser ( Lumenis ) hereafter known as the single pass device .
METHODS	Five laser treatments were performed 6 to 8 weeks apart with 1 , 6 , and 12 months follow-ups for hair counts .
METHODS	Pain was assessed in a subjective manner by the patients on a 10-point grading scale .
METHODS	Hair count analysis was performed in a blinded fashion .
RESULTS	There was a 33.5 % ( SD 46.8 % ) and 40.7 % ( SD 41.8 % ) reduction in hair counts at 6 months for the single pass and in-motion devices respectively ( P = 0.2879 ) .
RESULTS	The average pain rating for the single pass treatment ( mean 3.6 , 95 % CI : 2.8 to 4.5 ) was significantly ( P = 0.0007 ) greater than the in-motion treatment ( mean 2.7 , 95 % CI 1.8 to 3.5 ) .
CONCLUSIONS	This data supports the hypothesis that using diode lasers at low fluences and high average power with a multiple pass in-motion technique is an effective method for hair removal , with less pain and discomfort , while maintaining good efficacy .
CONCLUSIONS	The 6 month results were maintained at 12 month for both devices .

###25749597
BACKGROUND	Mindfulness-based cancer recovery ( MBCR ) and supportive-expressive therapy ( SET ) are well-validated psycho-oncological interventions , and we have previously reported health benefits of both programs .
BACKGROUND	However , little is known about patients ' characteristics or program preferences that may influence outcomes .
BACKGROUND	Therefore , this study examined moderators of the effects of MBCR and SET on psychological well-being among breast cancer survivors .
METHODS	A multi-site randomized controlled trial was conducted between 2007 and 2012 in two Canadian cities ( Calgary and Vancouver ) .
METHODS	A total of 271 distressed stage I-III breast cancer survivors were randomized into MBCR , SET or a 1-day stress management seminar ( SMS ) .
METHODS	Baseline measures of moderator variables included program preference , personality traits , emotional suppression , and repressive coping .
METHODS	Outcome measures of mood , stress symptoms , quality of life , spiritual well-being , post-traumatic growth , social support , and salivary cortisol were measured pre - and post intervention .
METHODS	Hierarchical regression analyses were used to assess moderator effects on outcomes .
RESULTS	The most preferred program was MBCR ( 55 % ) .
RESULTS	Those who were randomized to their preference improved more over time on quality of life and spiritual well-being post-intervention regardless of the actual intervention type received .
RESULTS	Women with greater psychological morbidity at baseline showed greater improvement in stress symptoms and quality of life if they received their preferred versus nonpreferred program .
CONCLUSIONS	Patients ' program preference and baseline psychological functioning , rather than personality , were predictive of program benefits .
CONCLUSIONS	These results suggest incorporating program preference can maximize the efficacy of integrative oncology interventions , and emphasize the methodological importance of assessing and accommodating for preferences when conducting mind-body clinical trials .

###24754328
OBJECTIVE	To examine the effect of an oral prenatal probiotic on group B Streptococcus ( GBS ) colonization and to demonstrate the feasibility of a larger randomized controlled trial .
METHODS	This pilot study was an open-label , two-group quasi-experiment .
METHODS	An urban central city nurse-midwifery and wellness center serving a diverse population .
METHODS	Ten pregnant participants received the oral probiotic ( Florajen3 ) taken once daily , and 10 participants served as controls .
METHODS	A questionnaire on dietary practices , vaginal cleansing , sexual history , and symptoms and GBS colony count samples were taken at 28 - , 32 - , and 36-weeks gestation .
RESULTS	Participants in the probiotic group reported no adverse events or minor side effects ; one half reported improved gastrointestinal symptoms .
RESULTS	Although two women in each group had positive qualitative prenatal GBS cultures at 36 weeks , the probiotic group participants had lower quantitative GBS colony counts .
RESULTS	The eight GBS negative averaged 90 % probiotic adherence compared with two GBS positive women who averaged 68 % .
RESULTS	Yogurt ingestion was inversely related ( p = .02 ) to GBS colonization .
CONCLUSIONS	Prenatal probiotic therapy has the potential to reduce GBS colonization .
CONCLUSIONS	The potential of the probiotic intervention appears to be linked to daily adherence .
CONCLUSIONS	A controlled clinical trial with a larger , adequately powered sample is feasible and justified .

###25707709
BACKGROUND	Moderate alcohol consumption has been associated with both negative and favorable effects on health .
BACKGROUND	The mechanisms responsible for reported favorable effects remain unclear .
BACKGROUND	Higher ( not necessarily elevated ) concentrations of serum bilirubin , an antioxidant , have also been associated with reduced risk of cardiovascular disease and all-cause mortality .
BACKGROUND	This study tests the hypothesis that single dose alcohol consumption elevates bilirubin providing a potential link between these observations .
METHODS	18 healthy individuals ( eight cigarette smokers ) were administered alcohol , calibrated to achieve blood concentrations of 20 , 80 and 120 mg/dL , in random order in three laboratory sessions separated by a week .
METHODS	Each session was preceded by and followed by 5-7 days of alcohol abstinence .
METHODS	Serum bilirubin was measured at 7:45 a.m. prior to drinking , at 2p .
METHODS	m. , and at 7:45 the next morning .
METHODS	Mixed effects regression models compared baseline and 24h post-drinking bilirubin concentrations .
RESULTS	Total serum bilirubin ( sum of indirect and direct ) concentration increased significantly after drinking from baseline to 24h in non-smokers ( from M = 0.38 , SD = 0.24 to M = 0.51 , SD = 0.30 , F ( 1,32.2 ) = 24.24 , p < .0001 ) but not in smokers ( from M = 0.25 , SD = 0.12 to M = 0.26 , SD = 0.15 , F ( 1,31.1 ) = 0.04 , p = 0.84 ) .
RESULTS	In nonsmokers the indirect bilirubin concentration and the ratio of indirect ( unconjugated ) to direct ( conjugated ) bilirubin also increased significantly .
CONCLUSIONS	Alcohol consumption leads to increases in serum bilirubin in nonsmokers .
CONCLUSIONS	Considering the antioxidant properties of bilirubin , our findings suggest one possible mechanism for the reported association between alcohol consumption and reduced risk of some disorders that could be tested in future longitudinal studies .

###24226057
OBJECTIVE	Earlier initiation of antiretroviral therapy ( ART ) in HIV-tuberculosis ( TB ) is associated with increased immune reconstitution inflammatory syndrome ( IRIS ) .
OBJECTIVE	The severity , frequency , and complications of TB IRIS were evaluated in A5221 , a randomized trial of earlier ART ( within 2 weeks after TB treatment initiation ) vs. later ART ( 8-12 weeks after TB treatment ) in HIV-infected patients starting TB treatment .
METHODS	In 806 participants , TB IRIS was defined using published clinical criteria .
METHODS	Cases were classified as severe ( hospitalization/death ) , moderate ( corticosteroid use/invasive procedure ) , or mild ( no hospitalization/procedures/steroids ) .
METHODS	Fisher exact , Wilcoxon , and log-rank tests were used for comparisons .
RESULTS	TB IRIS occurred in 61 ( 7.6 % ) patients : 10.4 % in earlier vs. 4.7 % in later ART , 11.5 % with CD4 < 50 vs. 5.4 % with CD4 50 cells per cubic millimeter .
RESULTS	The CD4/ART arm interaction was significant , P = 0.014 , with 44.3 % of TB IRIS occurring with CD4 < 50 and earlier ART .
RESULTS	TB IRIS occurred sooner with earlier vs. later ART initiation , at a median of 29 vs. 82 days after TB treatment initiation ( P < 0.001 ) .
RESULTS	IRIS manifestations included lymphadenopathy ( 59.0 % ) , constitutional symptoms ( 54.1 % ) , and radiographic changes ( 41.0 % ) ; central nervous system TB IRIS was uncommon ( 6.6 % ) .
RESULTS	TB IRIS was mild in 27.9 % , moderate in 41.0 % , and severe in 31.1 % .
RESULTS	No TB IRIS-associated deaths occurred .
RESULTS	IRIS management required 1 invasive procedures in 34.4 % , hospitalization in 31.1 % , and corticosteroids in 54.1 % .
CONCLUSIONS	TB IRIS was more frequent with earlier ART initiation and CD4 < 50 cells per cubic millimeter .
CONCLUSIONS	As ART is implemented earlier in HIV-TB coinfection , programs will require the diagnostic capabilities , clinical resources , and training necessary to manage TB IRIS .

###25609193
BACKGROUND	Trelagliptin is a novel once-weekly oral DPP-4 inhibitor .
BACKGROUND	We assessed the efficacy and safety of trelagliptin versus the daily oral DPP-4 inhibitor alogliptin in Japanese patients with type 2 diabetes .
METHODS	We did a randomised , double-blind , active-controlled , parallel-group , phase 3 , non-inferiority study at 26 sites in Japan .
METHODS	We included individuals with type 2 diabetes inadequately controlled by diet and exercise .
METHODS	We randomly assigned patients ( 2:2:1 ) to receive trelagliptin ( 100 mg ) once per week , alogliptin ( 25 mg ) once per day , or placebo for 24 weeks .
METHODS	Randomisation was done electronically and independently from the study with permuted blocks of ten patients .
METHODS	Patients and clinicians were masked to group assignment .
METHODS	Patients in the trelagliptin group were given trelagliptin once a week and oral alogliptin placebo every day , whereas patients in the alogliptin group were given oral trelagliptin placebo once a week and oral alogliptin every day ( double-dummy design ) .
METHODS	Patients in the placebo group were given an oral alogliptin placebo once a day and an oral trelagliptin placebo once a week .
METHODS	Our primary outcome was between-groups difference in change in HbA1c concentration from baseline to the end of treatment .
METHODS	The non-inferiority margin was 04 % .
METHODS	Our analysis included all patients who were randomised and received at least one dose of study drug .
METHODS	The study is registered with ClinicalTrials.gov , number NCT01632007 .
RESULTS	Between May 26 , 2012 , and Nov 20 , 2012 , we enrolled 357 patients .
RESULTS	243 patients were included in the analysis ( 101 for trelagliptin , 92 for alogliptin , and 50 for placebo ) .
RESULTS	In the primary analysis , the least squares mean change in HbA1c concentration was -033 % in the trelagliptin group ( SE 0059 ) and -045 % in the alogliptin group ( 0061 ) based on the ANCOVA model .
RESULTS	The least squares mean difference ( trelagliptin minus alogliptin ) of change from baseline in HbA1c concentration was 011 % ( 95 % CI -0054 to 0281 ) .
RESULTS	Trelagliptin was non-inferior to alogliptin .
RESULTS	Both active groups had significantly reduced mean HbA1c concentrations at end of treatment compared with placebo ( p < 00001 ) .
RESULTS	The frequency of adverse events was similar between groups .
RESULTS	No hypoglycaemia was reported with trelagliptin and the drug was well tolerated .
CONCLUSIONS	The once-weekly DPP-4 inhibitor trelagliptin showed similar efficacy and safety to alogliptin once daily in Japanese patients with type 2 diabetes .
CONCLUSIONS	Trelagliptin could be a useful new antidiabetes drug that needs to be given once a week .
BACKGROUND	Takeda Pharmaceutical Company .

###25416241
OBJECTIVE	According to the literature , voice rest following phonosurgery , as recommended in clinical practice , varies between 3 and 7 days .
OBJECTIVE	However , up until now , no randomized trials have been published comparing voice rest of short versus long duration .
METHODS	This is an ongoing prospective randomized study , comparing strict voice rest of 5 versus 10 days on the voice following phonosurgery .
METHODS	Thirty-one elective patients operated on for benign laryngeal lesions were randomized .
METHODS	They completed pre - and postoperative assessments , including perceptual voice quality ( Grade , Roughness , Breathiness , Asthenia , Strain , Instability scale ) , Voice Handicap Index total score , and voice analysis with both acoustic and aerodynamic measurements .
METHODS	Additional factors such as smoking , vocal abuse , reflux , and preoperative speech therapy were also taken into account .
RESULTS	Sixteen patients were randomized to follow 5 days ' voice rest and 15 patients were randomized to 10 days ' voice rest .
RESULTS	Statistical analysis showed no significant differences in pre - or postoperative measurements between the 2 groups .
RESULTS	However , multilinear regression analysis for the effect of voice rest duration on postoperative values showed a significant improvement in maximum phonation time ( MPT ) with 10 days ' voice rest .
CONCLUSIONS	Preliminary results show a benefit of prolonged voice rest ( 10 days ' duration ) on MPT .

###24503402
OBJECTIVE	To explore the efficacy and safety of fondaparinux combined with tirofiban in patients with high risk unstable angina ( UA ) undergoing complex percutaneous coronary intervention ( PCI ) .
METHODS	A total of 389 patients were enrolled and randomized into two groups receiving either fondaparinux with tirofiban or enoxaparin with tirofiban .
METHODS	Bleeding , thrombosis and main adverse cardiovascular events ( MACE ) were compared between the two groups during hospitalization , at week 2 and week 4 after discharge .
RESULTS	No severe bleeding was observed during hospitalization in the both groups , while lower rate of mild and minor bleeding was shown in the fondaparinux group ( 0 vs 1.5 % and 18.2 % vs 34.5 % , P = 0.04 and P < 0.001 respectively ) .
RESULTS	No difference was found between the two groups in the rate of MACE during hospitalization , at week 2 and week 4 weeks after discharge .
RESULTS	The rates of death , recurrent myocardial infarction , refractory myocardial ischemia and target vessel revascularization were 0.5 % vs 1.0 % , 0.5 % vs 1.0 % , 1.6 % vs 1.0 % and 2.1 % vs 1.5 % during hospitalization ; 0 vs 0 , 1.0 % vs 0.5 % , 1.0 % vs 1.5 % , 0.5 % vs 1.0 % at week 2 after discharge ; 0.5 % vs 0.5 % , 0.5 % vs 0.5 % , 2.6 % vs 2.0 % , 0 vs 0.5 % at week 4 after discharge ( all P values > 0.05 ) .
CONCLUSIONS	The combination therapy of fondaparinux and tirofiban is of good safety and efficacy in high risk UA patients undergoing complex PCI .

###25271207
OBJECTIVE	Insulin adjustments to maintain glycemic control in individuals with type 1 diabetes often lead to wide glucose fluctuations , hypoglycemia , and increased body weight .
OBJECTIVE	Dapagliflozin , an insulin-independent sodium-glucose cotransporter 2 ( SGLT2 ) inhibitor , increases glucosuria and reduces hyperglycemia in individuals with type 2 diabetes .
OBJECTIVE	The primary objective of this study was to assess short-term safety of dapagliflozin in combination with insulin ; secondary objectives included pharmacokinetic , pharmacodynamic , and efficacy parameters .
METHODS	A 2-week , dose-ranging , randomized , double-blind , placebo-controlled proof-of-concept study randomly assigned 70 adults with type 1 diabetes ( HbA1c 7-10 % ) , who were receiving treatment with stable doses of insulin , to one of four dapagliflozin doses ( 1 , 2.5 , 5 , or 10 mg ) or placebo .
METHODS	The insulin dose was not proactively reduced at randomization but could be adjusted for safety reasons .
RESULTS	Sixty-two patients ( 88.6 % ) completed the study .
RESULTS	Any hypoglycemia was common across all treatments ( 60.0-92 .3 % ) ; one major event of hypoglycemia occurred with dapagliflozin 10 mg .
RESULTS	No diabetic ketoacidosis occurred .
RESULTS	Pharmacokinetic parameters were similar to those observed in patients with type 2 diabetes .
RESULTS	Glucosuria increased by 88 g/24 h ( 95 % CI 55 to 121 ) with dapagliflozin 10 mg and decreased by -21.5 g/24 h ( 95 % CI -53.9 to 11.0 ) with placebo .
RESULTS	Changes from baseline with dapagliflozin 10 mg by day 7 were as follows : -2.29 mmol/L ( 95 % CI -3.71 to -0.87 [ -41.3 mg/dL ; 95 % CI -66.9 to -15.7 ] ) for 24-h daily average blood glucose ; -3.77 mmol/L ( 95 % CI -6.09 to -1.45 [ -63.1 mg/dL ; 95 % CI -111.5 to -14.8 ] ) for mean amplitude of glycemic excursion ; and -16.2 % ( 95 % CI -29.4 to -0.5 ) for mean percent change in total daily insulin dose .
RESULTS	Corresponding changes with placebo were as follows : -1.13 mmol/L ( 95 % CI -3.63 to 1.37 ) , -0.45 mmol/L ( 95 % CI -4.98 to 4.08 ) , and 1.7 % ( 95 % CI -22.8 to 33.9 ) , respectively .
RESULTS	However , for every efficacy parameter , the 95 % CIs for all dapagliflozin doses overlapped those for placebo .
CONCLUSIONS	This exploratory study of dapagliflozin in adults with type 1 diabetes demonstrated acceptable short-term tolerability and expected pharmacokinetic profiles and increases in urinary glucose excretion .
CONCLUSIONS	Within the dapagliflozin groups , dose-related reductions in 24-h glucose , glycemic variability , and insulin dose were suggested , which provide hope that SGLT2 inhibition may prove in larger randomized controlled trials to be efficacious in reducing hyperglycemia in type 1 diabetes .

###24622150
OBJECTIVE	To examine gender disparities in cognitive functioning in India and the extent to which education explains this disparity in later life .
METHODS	This study uses baseline interviews of a prospective cohort study of 1,451 community-residing adults 45 years of age or older in four geographically diverse states of India ( Karnataka , Kerala , Punjab , Rajasthan ) .
METHODS	Data collected during home visits includes cognitive performance tests , and rich sociodemographic , health , and psychosocial variables .
METHODS	The cognitive performance tests include episodic memory , numeracy , and a modified version of the Mini-Mental State Examination .
RESULTS	We find gender disparity in cognitive function in India , and this disparity is greater in the north than the south .
RESULTS	We also find that gender disparities in educational attainment , health , and social and economic activity explain the female cognitive disadvantage in later life .
CONCLUSIONS	We report significant gender disparities in cognitive functioning among older Indian adults , which differ from gender disparities in cognition encountered in developed countries .
CONCLUSIONS	Our models controlling for education , health status , and social and economic activity explain the disparity in southern India but not the region-specific disparity in the northern India .
CONCLUSIONS	North Indian women may face additional sources of stress associated with discrimination against women that contribute to persistent disadvantages in cognitive functioning at older ages .

###24460536
OBJECTIVE	To evaluate an incentive-based intervention to increase time spent outdoors among children in a 9-month cluster randomised controlled trial .
METHODS	Two hundred and eighty-five children aged 6-12years of age were randomised to the intervention ( n = 147 ) or control arm ( n = 138 ) in the Family incentive trial ( FIT ) .
METHODS	The FIT intervention comprised of targeted education on myopia and good eye care habits , structured weekend outdoor activities and incentives for children to increase their daily steps via pedometers .
METHODS	The main outcome measure was outdoor time , measured by the WHO questionnaire and a 1-week diary .
RESULTS	Interim analysis at 6months showed a significant increase in mean outdoor time per week in the intervention arm ( 14.75 hweek ( -1 ) ) compared to the control arm ( 12.40 hweek ( -1 ) ) as measured by the questionnaire ( p = 0.04 ) .
RESULTS	However , greater outdoor time was not statistically significant at the end of the trial ( 15.95 hweek ( -1 ) vs 14.34 h in the control group ( p = 0.29 ) .
CONCLUSIONS	There was an increase in outdoor time for children in the incentive-based physical activity outdoor program after 6months but not at the end of the trial .
CONCLUSIONS	Further larger school trials with better compliance with the intervention and longer duration could be conducted to evaluate clinical outcomes such as myopic shifts .

###26052984
BACKGROUND	Data are lacking on the long-term effect on cardiovascular events of adding sitagliptin , a dipeptidyl peptidase 4 inhibitor , to usual care in patients with type 2 diabetes and cardiovascular disease .
METHODS	In this randomized , double-blind study , we assigned 14,671 patients to add either sitagliptin or placebo to their existing therapy .
METHODS	Open-label use of antihyperglycemic therapy was encouraged as required , aimed at reaching individually appropriate glycemic targets in all patients .
METHODS	To determine whether sitagliptin was noninferior to placebo , we used a relative risk of 1.3 as the marginal upper boundary .
METHODS	The primary cardiovascular outcome was a composite of cardiovascular death , nonfatal myocardial infarction , nonfatal stroke , or hospitalization for unstable angina .
RESULTS	During a median follow-up of 3.0 years , there was a small difference in glycated hemoglobin levels ( least-squares mean difference for sitagliptin vs. placebo , -0.29 percentage points ; 95 % confidence interval [ CI ] , -0.32 to -0.27 ) .
RESULTS	Overall , the primary outcome occurred in 839 patients in the sitagliptin group ( 11.4 % ; 4.06 per 100 person-years ) and 851 patients in the placebo group ( 11.6 % ; 4.17 per 100 person-years ) .
RESULTS	Sitagliptin was noninferior to placebo for the primary composite cardiovascular outcome ( hazard ratio , 0.98 ; 95 % CI , 0.88 to 1.09 ; P < 0.001 ) .
RESULTS	Rates of hospitalization for heart failure did not differ between the two groups ( hazard ratio , 1.00 ; 95 % CI , 0.83 to 1.20 ; P = 0.98 ) .
RESULTS	There were no significant between-group differences in rates of acute pancreatitis ( P = 0.07 ) or pancreatic cancer ( P = 0.32 ) .
CONCLUSIONS	Among patients with type 2 diabetes and established cardiovascular disease , adding sitagliptin to usual care did not appear to increase the risk of major adverse cardiovascular events , hospitalization for heart failure , or other adverse events .
CONCLUSIONS	( Funded by Merck Sharp & Dohme ; TECOS ClinicalTrials.gov number , NCT00790205 . )

###24814767
BACKGROUND	The primary aim of this study was to determine whether mesh pore size influences the rate of chronic pain at 6-mo follow-up .
BACKGROUND	Another aim was to evaluate the rate of foreign body feeling and quality of life after inguinal hernia repair .
METHODS	The patients were randomized into two study groups : the UM group received Ultrapro mesh ( pore size 3-4 mm ) and the OM group received Optilene LP mesh ( pore size 1 mm ) .
METHODS	Pain scores were measured on a visual analog scale .
METHODS	The feeling of a foreign body was a yes-or-no question .
METHODS	Quality of life was evaluated using the Medical Outcome Study Short-Form-36 questionnaire .
RESULTS	A total of 67 patients in the UM group and 67 patients in the OM group were investigated 6 mo after operation .
RESULTS	There were no significant differences in the results of the pain questionnaire between the study groups .
RESULTS	Of the patients , 46.3 % in the UM group reported pain during different activities at 6-mo follow-up versus 34.3 % in the OM group ( P = 0.165 ) .
RESULTS	The feeling of a foreign body in the inguinal region was experienced by 47.8 % of the patients in the UM group and by 31.3 % of the patients in the OM group at 6-mo follow-up ( P = 0.052 ; risk ratio 1.52 , 95 % confidence interval : 1.00-2 .37 ) .
RESULTS	There were no significant differences in the quality of life according to the Short-Form 36 questionnaire between the two study groups at 6-mo follow-up .
RESULTS	In both study groups , the quality of life scores improved after operation by most dimensions .
CONCLUSIONS	Differences in mesh pore size did not influence the rate of chronic pain .
CONCLUSIONS	Although there was a trend for higher rate of foreign body feeling in the study group where a mesh with larger pores was used , we failed to find an explanation for this .
CONCLUSIONS	The pore size of meshes investigated in this study did not affect the quality of life after inguinal hernia repair .
CONCLUSIONS	Considering the fact that the quality of life improved significantly after operation , elective repair of symptomatic inguinal hernias should be undertaken as promptly as possible .

###24433264
BACKGROUND	Surgical site infections are the third most frequent type of nosocomial infections .
BACKGROUND	Evidence-based recommendations have been given regarding preoperative hospitalization , hygiene and air-conditioning , patient conditions , and wound dressing .
BACKGROUND	However , no general recommendations concerning wound closure exist .
BACKGROUND	Systematic reviews and meta-analyses suppose a benefit of intracutaneous suture compared to skin staples in orthopedic and obstetric surgery .
BACKGROUND	Literature data for skin closure in elective abdominal surgery are still deficient .
METHODS	Patients scheduled for any elective abdominal surgery requiring midline or horizontal laparotomy are potentially eligible for the trial .
METHODS	Trial-specific exclusion criteria are date of admission exceeding four days prior to surgery , antibiotic treatment within the past 14 days , any previous midline or horizontal laparotomy in case the procedure requires the same skin incision as before , neurophysiological deficits or severe psychiatric or neurologic diseases that do not allow an informed consent or compliance , and participation in any other interventional trial with interference of intervention and outcome .
METHODS	The trial is created for process innovation within standardized surgical procedures .
METHODS	It is designed as a prospective randomized controlled single center trial in a parallel design including an active comparator and an intervention group .
METHODS	The intervention addresses the closure of skin after the main surgical procedure : intracutaneous suture in the intervention group and transcutaneous skin stapling in the control group .
METHODS	The rate of superficial surgical site infections is defined as the primary endpoint .
METHODS	Secondary endpoints are time for skin closure , satisfaction with the cosmetic outcome 30 days after surgery , prolongation of hospital stay , and duration of sick-leave due to surgical site infections .
METHODS	The primary efficacy analysis follows the intention-to-treat principle .
METHODS	A 2 test will be applied .
CONCLUSIONS	The trial is expected to balance the shortcomings of the current evidence .
CONCLUSIONS	It will help to define the gold standard for wound closure in elective abdominal surgery .
CONCLUSIONS	Patients ' safety and quality of life are assumed to be enhanced .
CONCLUSIONS	Therapy costs are likely to be reduced and health care optimized .
BACKGROUND	German Clinical Trials Register ( DRKS ) DRKS00004542 .

###24793364
BACKGROUND	Adjunctive behavioral smoking cessation treatments have the potential to improve outcomes beyond standard care .
BACKGROUND	The present study had two aims : ( 1 ) compare standard care ( SC ) for smoking ( four weeks of brief counseling and monitoring ) to SC plus prize-based contingency management ( CM ) , involving the chance to earn prizes on days with demonstrated smoking abstinence ( carbon monoxide ( CO ) 6 ppm ) ; and ( 2 ) compare the relative efficacy of two prize reinforcement schedules-one a traditional CM schedule , and the second an early enhanced CM schedule providing greater reinforcement magnitude in the initial week of treatment but equal overall reinforcement .
METHODS	Participants ( N = 81 nicotine-dependent cigarette smokers ) were randomly assigned to one of the three conditions .
RESULTS	Prize CM resulted in significant reductions in cigarette smoking relative to SC .
RESULTS	These reductions were not apparent at follow-up .
RESULTS	We found no meaningful differences between the traditional and enhanced CM conditions .
CONCLUSIONS	Our findings reveal that prize CM leads to significant reductions in smoking during treatment relative to a control intervention , but the benefits did not extend long-term .

###25185361
OBJECTIVE	To study the therapeutic effect Bufei granule , which is a traditional Chinese drug that can enhance the immune function of the lung , on patients with stable chronic obstructive pulmonary disease ( COPD ) .
METHODS	This is a randomized , double blinded , placebo-controlled , and multicenter clinical study .
METHODS	Three medical centers in Tianjin , China , participated in the trial .
METHODS	A total of 140 patients with stable COPD were enrolled and randomized into two groups , with 70 patients in each .
METHODS	The treatment group was treated with Bufei granule , while the control group received Bufei placebo .
METHODS	The pharmacological treatment lasted for 12 weeks from the date of enrollment .
METHODS	Then , the indexes of patients were observed .
METHODS	Data were analyzed to study the effect of Bufei granule , with the frequency of acute exacerbation as the primary outcome .
METHODS	Traditional Chinese Medicine syndromes , Modified British Medical Research Council dyspnea scale score , St. George 's respiratory questionnaire scores , pulmonary function , and serum inflammatory marker levels [ including interleukin-6 ( IL-6 ) , interleukin-8 , tumor necrosis factor-alpha , and transformation growth factor-beta1 ] were the secondary outcomes .
RESULTS	During the 12-week treatment , treatment and control groups had no adverse reactions .
RESULTS	The analysis of the indexes obtained from all patients showed that the therapeutic effect in the treatment group was significantly better than that in the control group because most of the similar probabilities of primary and secondary outcomes were less than 0.05 , except for the level of IL-6 .
CONCLUSIONS	Bufei granule can treat patients with stable COPD by lowering the frequency of acute exacerbation , improving the quality of life , and alleviating the severity of inflammation .

###26028518
BACKGROUND	Early risk-stratified chemotherapy is a standard treatment for breast , colorectal , and lung cancers , but not for high-risk localised prostate cancer .
BACKGROUND	Combined docetaxel and estramustine improves survival in patients with castration-resistant prostate cancer .
BACKGROUND	We assessed the effects of combined docetaxel and estramustine on relapse in patients with high-risk localised prostate cancer .
METHODS	We did this randomised phase 3 trial at 26 hospitals in France .
METHODS	We enrolled patients with treatment-naive prostate cancer and at least one risk factor ( ie , stage T3-T4 disease , Gleason score of 8 , prostate-specific antigen concentration > 20 ng/mL , or pathological node-positive ) .
METHODS	All patients underwent a staging pelvic lymph node dissection .
METHODS	Patients were randomly assigned ( 1:1 ) to either androgen deprivation therapy ( ADT ; goserelin 108 mg every 3 months for 3 years ) plus four cycles of docetaxel on day 2 at a dose of 70 mg/m ( 2 ) and estramustine 10 mg/kg per day on days 1-5 , every 3 weeks , or ADT only .
METHODS	The randomisation was done centrally by computer , stratified by risk factor .
METHODS	Local treatment was administered at 3 months .
METHODS	Neither patients nor investigators were masked to treatment allocation .
METHODS	The primary endpoint was relapse-free survival in the intention-to-treat population .
METHODS	Follow-up for other endpoints is ongoing .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00055731 .
RESULTS	We randomly assigned 207 patients to the ADT plus docetaxel and estramustine group and 206 to the ADT only group .
RESULTS	Median follow-up was 88 years ( IQR 81-97 ) .
RESULTS	88 ( 43 % ) of 207 patients in the ADT plus docetaxel and estramustine group had an event ( relapse or death ) versus 111 ( 54 % ) of 206 in the ADT only group .
RESULTS	8-year relapse-free survival was 62 % ( 95 % CI 55-69 ) in the ADT plus docetaxel and estramustine group versus 50 % ( 44-57 ) in the ADT only group ( adjusted hazard ratio [ HR ] 071 , 95 % CI 054-094 , p = 0017 ) .
RESULTS	Of patients who were treated with radiotherapy and had data available , 31 ( 21 % ) of 151 in the ADT plus docetaxel and estramustine group versus 26 ( 18 % ) of 143 in the ADT only group reported a grade 2 or higher long-term side-effect ( p = 061 ) .
RESULTS	We recorded no excess second cancers ( 26 [ 13 % ] of 207 vs 22 [ 11 % ] of 206 ; p = 057 ) , and there were no treatment-related deaths .
CONCLUSIONS	Docetaxel-based chemotherapy improves relapse-free survival in patients with high-risk localised prostate cancer .
CONCLUSIONS	Longer follow-up is needed to assess whether this benefit translates into improved metastasis-free survival and overall survival .
BACKGROUND	Ligue Contre le Cancer , Sanofi-Aventis , AstraZeneca , Institut National du Cancer .

###24916483
BACKGROUND	Septic shock is common and has unacceptably high morbidity , mortality , and associated cost with numerous failed attempts at developing effective therapies .
BACKGROUND	Endotoxin , one of the most potent mediators of sepsis , is found in high levels in approximately 50 % of patients with septic shock .
BACKGROUND	Polymyxin B ( PMX ) hemoperfusion has been shown in numerous studies to successfully remove endotoxin and potentially improve outcomes .
BACKGROUND	EUPHRATES ( Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized controlled trial of Adults Treated for Endotoxemia and Septic shock ) is a theragnostic trial ( matching blood measurement to treatment capability ) of PMX hemoperfusion in patients with septic shock and confirmed endotoxemia as measured by the endotoxin activity assay ( EAA ) .
METHODS	EUPHRATES is a pivotal regulatory trial that is multi-centered , placebo-controlled and blinded .
METHODS	The trial is being conducted in fifty ICUs in the United States and Canada and is powered to enroll 360 patients .
METHODS	Patients with persistent septic shock despite adequate fluid resuscitation on vasopressors for more than 2 and less than 30 hours are eligible for measurement of the EAA .
METHODS	Those with EAA 0.60 are eligible to be randomized to treatment with two sessions of PMX hemoperfusion 24 hours apart .
METHODS	The primary endpoint for the trial is 28-day all-cause mortality .
CONCLUSIONS	Unique features of the trial include absence of systemic inflammatory response ( SIRS ) criteria as a requirement for inclusion , use of the EAA to confirm endotoxemia as a requisite for treatment , and use of a detailed `` faade '' hemoperfusion event as a blinding mechanism .
CONCLUSIONS	The outcomes of the second interim analysis included a resizing of the trial to 650 patients and the addition of an exclusion criterion of subjects with multiple organ dysfunction score ( MODS ) 9 .
CONCLUSIONS	Results are anticipated in 2016 .
BACKGROUND	Clinicaltrials.gov identifier : NCT01046669 .
BACKGROUND	Registered : January 8 , 2010 .

###25452049
OBJECTIVE	To investigate baseline and concurrent predictors of non-use of illicit heroin among participants randomized to injectable opioids in the North American Opiate Medication Initiative ( NAOMI ) clinical trial .
METHODS	NAOMI was an open-label randomized controlled trial comparing the effectiveness of injectable diacetylmorphine and hydromorphone for long-term opioid-dependency .
METHODS	Outcomes were assessed at baseline and during treatment ( 3 , 6 , 9 , 12months ) .
METHODS	Days of non-use of illicit heroin in the prior month at each follow-up visit were divided into three categories : Non-use ; Low use ( 1 to 7days ) and High use ( 8days or more ) .
METHODS	Tested covariates were : Sociodemographics , Health , Treatment , Drug use and illegal activities .
METHODS	Mixed-effect proportional odds models with random intercept for longitudinal ordinal outcomes were used to assess the predictors of the non-use of illicit heroin .
RESULTS	139 participants were included in the present analysis .
RESULTS	At each follow-up visit , those with non-use of illicit heroin represented 47.5 % to 54.0 % of the sample .
RESULTS	Fewer days of cocaine use ( p = 0.074 ) , fewer days engaged in illegal activities at baseline ( p < 0.01 ) and at each visit ( p < 0.01 ) , less money spent on drugs ( p < 0.001 ) , days with injection opioid or oral methadone treatment ( p < 0.001 ) and total mg of injectable opioids taken ( p < 0.001 ) , independently predicted lower use of illicit heroin .
CONCLUSIONS	The independent effect of several concurrent factors besides the injection of opioid dose suggests benefits from the clinic that go beyond the provision of the medication alone .
CONCLUSIONS	Thus , this supervised model of care presents an opportunity to maximize the beneficial impact of medical and psychosocial components of the treatment on improving outcomes associated with non-use of illicit heroin .

###24967423
BACKGROUND	The use of videolaryngoscopes is recommended for morbidly obese patients .
BACKGROUND	The aim of the study was to evaluate the Levitan FPS optical stylet ( Levitan ) vs Lafy-Flex videolaryngoscope ( Lary-Flex ) in a group of MO patients .
METHODS	Seventy-nine MO ( BMI > 40 kg m ( -2 ) ) patients scheduled for bariatric surgery were included in the study and randomly allocated to the Levitan FPS or Lary-Flex group .
METHODS	The primary endpoint was time to intubation and evaluation laryngoscopic of glottic view .
METHODS	Anesthesiologists were asked to evaluate the glottic view first under direct laryngoscopy using the videolaryngoscope as a standard laryngoscope ( monitor display was excluded from use ) and then using devices .
METHODS	The secondary endpoint was the cardiovascular response to intubation and the participant 's evaluation of such devices .
RESULTS	The time to intubation was 8.572.66 sec .
RESULTS	versus 5.790.2 sec .
RESULTS	for Levitan and Lary-Flex , respectively ( P < 0.05 ) .
RESULTS	In all cases of CL grade > 1 under direct laryngoscopy , the study devices improved CL grade to 1 .
RESULTS	The Levitan FPS produced a greater cardiovascular response than the Lary-Flex videolaryngoscope .
CONCLUSIONS	The Lary-Flex videolaryngoscope and the Levitan FPS optical stylet improve the laryngeal visualization in morbidly obese patients , allowing for fast endotracheal intubation , but Lary-Flex produces less cardiovascular response to intubation attempt .

###24519421
OBJECTIVE	The aim of the present randomized , double-blind , placebo-controlled clinical trial was to assess the efficacy and tolerability of 0.5 % indomethacin ( INDOM ) eye drops in adult patients suffering from macular edema ( ME ) related to different etiology uveitis .
METHODS	Forty-six eyes of 31 adult patients ( 20 females and 11 males ) mean age 39 years , affected by inflammatory ME , were randomized to receive a dose of commercial 0.5 % INDOM eye-drops four times per day ( 16 subjects = 23 eyes ) or placebo ( the vehicle of INDOM , 15 subjects = 23 eyes ) during a 6-month active therapy follow-up .
METHODS	Study assessment at each visit included visual acuity testing ( VA ) , slit-lamp examination , IOP evaluation , and Heidelberg Spectralis optical coherence tomography ( OCT ) central foveal thickness ( CFT ) measurement .
METHODS	Any variation in subjective symptoms and tolerability was also detected .
RESULTS	Statistical analysis showed , from baseline to the 6-month visit , a significant reduction in CFT ( P < 0.0001 ) and a significant improvement in VA only in the 0.5 % INDOM-treated group ; a global reduction of discomfort symptoms was present in both groups ( P < 0.001 ) .
CONCLUSIONS	The four times per day administration of 0.5 % INDOM eye drops in eyes affected with uveitic ME from different etiologies , compared with placebo , is associated with a significant reduction in ME at the 6-month follow-up visit , as measured by spectral-domain optical coherence tomography ( SD-OCT ) .
CONCLUSIONS	However , not all eyes showed a complete resolution of ME because of vitreoretinal traction .
CONCLUSIONS	( https://eudract.ema.europa.eu/index.html number , EUDRACT 2011-001522-20 . )

###25287282
OBJECTIVE	To assess the effect and safety of moderate-to-vigorous resistance exercise during pregnancy .
METHODS	Randomized controlled study .
METHODS	Two antenatal clinics in Gothenburg , Sweden .
METHODS	Ninety-two healthy pregnant women .
METHODS	The intervention was administered during gestational weeks 14-25 .
METHODS	The intervention group received supervised resistance exercise twice a week , performed at an activity level equivalent to within moderate-to-vigorous ( n = 51 ) .
METHODS	The control group received generalized exercise recommendation , a home-based training program and a telephone follow up ( n = 41 ) .
METHODS	Health-related quality of life , physical strength , pain , weight , blood pressure , functional status , activity level , and perinatal data .
RESULTS	Functional status deteriorated during the intervention in both groups and pain increased .
RESULTS	Significant differences between the groups were obtained only for birthweight .
RESULTS	Newborns delivered by women who underwent resistance exercise during pregnancy were significantly heavier than those born to control women ; 3561 ( 452 ) g vs. 3251 ( 437 ) g ( p = 0.02 ) , a difference that disappeared when adjustment was made for gestational age ( p = 0.059 ) .
RESULTS	Both groups showed normal health-related quality of life , blood pressure , and perinatal data .
CONCLUSIONS	These findings indicate that supervised , moderate-to-vigorous resistance exercise does not jeopardize the health status of healthy pregnant women or the fetus during pregnancy , but instead appears to be an appropriate form of exercise in healthy pregnancy .

###24791863
BACKGROUND	The interleukin ( IL ) -32 / tumor necrosis factor ( TNF ) a pathway is supposed to play a key role in the amplification of the immune response in chronic obstructive pulmonary disease ( COPD ) inflammation .
BACKGROUND	Inhaled corticosteroids ( ICS ) in combination with long-acting 2-agonists ( LABA ) have shown airway anti-inflammatory effects in recent studies , but the mechanism is still uncertain .
METHODS	Patients were treated in a randomized , open-labeled , parallel group clinical trial with either a combination of salmeterol xinafoate/fluticasone propionate ( SF ; Seretide , GlaxoSmithKline ) Diskus ( 50/500 g twice daily ) or ipratropium bromide/salbutamol ( IS ; Combivent , Boehringer Ingelheim ) MDI ( 42 g/240 g quartic daily ) for 12 weeks .
METHODS	At the start and the end of treatment , induced sputum was collected and the concentration of IL-32 and TNF - , the number of neutrophils and eosinophils were measured .
RESULTS	Following 12 weeks of treatment , a statistically significant fall from baseline in the concentration of TNF - in sputum ( P = 0.004 ) was seen after treatment with SF but not with IS .
RESULTS	However , neither treatment had significant effects on the concentration of IL-32 in sputum .
RESULTS	There was a decrease from baseline in the number of sputum neutrophils with SF that approached statistical significance ( P = 0.028 ) but not with IS , while the number of sputum eosinophils did not change significantly from baseline in either treatment group .
RESULTS	There was a statistically significant decline from baseline in the quality of life as assessed by the St George 's respiratory questionnaire in both the SF ( P = 0.004 ) and IS ( P = 0.030 ) treatment groups , but no evidence of improvement in lung function was observed in either group .
CONCLUSIONS	The sputum TNF - and neutrophils , but not IL-32 and macrophages , could be reduced by ICS/LABA treatment , suggesting that IL-32 could be involved in the corticosteroid resistance of COPD inflammation .

###25406305
BACKGROUND	Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist ( TOPCAT ) patients with heart failure and preserved left ventricular ejection fraction assigned to spironolactone did not achieve a significant reduction in the primary composite outcome ( time to cardiovascular death , aborted cardiac arrest , or hospitalization for management of heart failure ) compared with patients receiving placebo .
BACKGROUND	In a post hoc analysis , an 4-fold difference was identified in this composite event rate between the 1678 patients randomized from Russia and Georgia compared with the 1767 enrolled from the United States , Canada , Brazil , and Argentina ( the Americas ) .
RESULTS	To better understand this regional difference in clinical outcomes , demographic characteristics of these populations and their responses to spironolactone were explored .
RESULTS	Patients from Russia/Georgia were younger , had less atrial fibrillation and diabetes mellitus , but were more likely to have had prior myocardial infarction or a hospitalization for heart failure .
RESULTS	Russia/Georgia patients also had lower left ventricular ejection fraction and creatinine but higher diastolic blood pressure ( all P < 0.001 ) .
RESULTS	Hyperkalemia and doubling of creatinine were more likely and hypokalemia was less likely in patients receiving spironolactone in the Americas with no significant treatment effects in Russia/Georgia .
RESULTS	All clinical event rates were markedly lower in Russia/Georgia , and there was no detectable impact of spironolactone on any outcomes .
RESULTS	In contrast , in the Americas , the rates of the primary outcome , cardiovascular death , and hospitalization for heart failure were significantly reduced by spironolactone .
CONCLUSIONS	This post hoc analysis demonstrated greater potassium and creatinine changes and possible clinical benefits with spironolactone in patients with heart failure and preserved ejection fraction from the Americas .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00094302 .

###24504788
OBJECTIVE	The relationship between low back pain ( LBP ) and the lifting/carrying of loads is still a matter of great discussion .
OBJECTIVE	In teenagers , the weight of the school bag has been considered to play a pathogenic role in LBP but the relationship between the actual weight of the school bag and LBP symptoms does not seem to be a straightforward one .
OBJECTIVE	Numerous factors have been identified that influence the perception of weight .
OBJECTIVE	This study aimed to evaluate the influence of low back pain and the type of container on the perception of load heaviness by healthy teenagers .
METHODS	A convenience sample of 80 healthy teenage males ( mean SD age 13.9 2.1 years ) was recruited from the members of two local sports clubs .
METHODS	The volunteers were evaluated during one of their training sessions .
METHODS	Information about a history of consequential LBP was gathered by questionnaire .
METHODS	Subjects were invited to estimate the weight of three bags ( a typical school bag , a sports bag with the logo of a well-known brand , and a neutral bag ) containing two different loads ( total weights approximately 3 and 5 kg ) .
RESULTS	Consequential LBP ( i.e. , LBP requiring medical attention and/or interfering with usual sports activities ) was reported by 26.2 % of them .
RESULTS	The majority of the LBP episodes occurred 3 months before the tests .
RESULTS	Overall , teenagers significantly ( p 0.05 ) underestimated the weight of the sports bag compared with the school bag and the neutral bag .
RESULTS	Compared with those with no LBP , subjects with a history of LBP overestimated the weight of the heavier load .
CONCLUSIONS	Our results suggest that several subjective variables significantly influence the perception of load heaviness .
CONCLUSIONS	Until we have a better understanding of the mechanical role of the backpack weight versus the perception of its weight in the aetiology of LBP , any recommendations about the schoolbag weight limit should be viewed with caution .

###24509969
BACKGROUND	Abdominal Cesarean sections ( C-sections ) are frequently associated with an increased risk of excessive or unpleasant scarring .
BACKGROUND	A topical scar gel containing extract of Allium cepae , allantoin and heparin ( Contractubex ; Merz Pharmaceuticals GmbH , Germany ) , has shown efficacy in improving the appearance of various scar types .
OBJECTIVE	To investigate the efficacy of the topical scar gel , Contractubex , in the early treatment of C-section scars .
METHODS	A total of 61 females , aged 18 years , who had given birth by elective C-section for the first time within the last 5-10 days , were included in this prospective , randomized , single-center study .
METHODS	Patients were advised to apply the topical scar gel twice daily ( treatment group ) , or received no treatment ( control group ) .
METHODS	Efficacy was evaluated at 6 and 12 weeks after a baseline visit using the Patient and Observer Scar Assessment Scale ( POSAS ) , a validated scar assessment tool comprised of a Patient Scale and an Observer Scale .
RESULTS	Analysis revealed a significant change in the POSAS Patient Scale total score , with a 14.2 % improvement in the treatment group compared with a decline of similar magnitude ( -14.8 % ) in the control group at week 6 .
RESULTS	Significant improvements were also seen for POSAS Patient Scale sub-items in the treatment group compared with the control group for scar color ( 13.6 % vs -18.5 % , respectively , P = 0.0284 ) , stiffness ( 12.5 % vs -34.6 % , respectively , P = 0.0029 ) , and irregularity ( 29.4 % vs -46.2 % , respectively , P = 0.0140 ) after 6 weeks of treatment .
RESULTS	No significant changes were observed for the POSAS Observer Scale total score or its subitems after treatment with the topical scar gel , although there was a strong overall trend in favor of the treatment group .
RESULTS	No significant adverse events were observed during the study .
CONCLUSIONS	Contractubex represents an efficacious and well-tolerated preventative treatment that rapidly and significantly improves the color , stiffness and irregularity of C-section scars .

###24507377
BACKGROUND	Existing treatments for postherpetic neuralgia , and for neuropathic pain in general , are limited by modest efficacy and unfavourable side-effects .
BACKGROUND	The angiotensin II type 2 receptor ( AT2R ) is a new target for neuropathic pain .
BACKGROUND	EMA401 , a highly selective AT2R antagonist , is under development as a novel neuropathic pain therapeutic agent .
BACKGROUND	We assessed the therapeutic potential of EMA401 in patients with postherpetic neuralgia .
METHODS	In this multicentre , placebo-controlled , double-blind , randomised , phase 2 clinical trial , we enrolled patients ( aged 22-89 years ) with postherpetic neuralgia of at least 6 months ' duration from 29 centres across six countries .
METHODS	We randomly allocated 183 participants to receive either oral EMA401 ( 100 mg twice daily ) or placebo for 28 days .
METHODS	Randomisation was done according to a centralised randomisation schedule , blocked by study site , which was generated by an independent , unmasked statistician .
METHODS	Patients and staff at each site were masked to treatment assignment .
METHODS	We assessed the efficacy , safety , and pharmacokinetics of EMA401 .
METHODS	The primary efficacy endpoint was change in mean pain intensity between baseline and the last week of dosing ( days 22-28 ) , measured on an 11-point numerical rating scale .
METHODS	The primary efficacy analysis was intention to treat .
METHODS	This trial is registered with the Australian New Zealand Clinical Trials Registry , number ACTRN12611000822987 .
RESULTS	92 patients were assigned to EMA401 and 91 were assigned to placebo .
RESULTS	The patients given EMA401 reported significantly less pain compared with baseline values in the final week of treatment than did those given placebo ( mean reductions in pain scores -2.29 [ SD 1.75 ] vs -1.60 [ 1.66 ] ; difference of adjusted least square means -0.69 [ SE 0.25 ] ; 95 % CI -1.19 to -0.20 ; p = 0.0066 ) .
RESULTS	No serious adverse events related to EMA401 occurred .
RESULTS	Overall , 32 patients reported 56 treatment-emergent adverse events in the EMA401 group compared with 45 such events reported by 29 patients given placebo .
CONCLUSIONS	EMA401 ( 100 mg twice daily ) provides superior relief of postherpetic neuralgia compared with placebo at the end of 28 days of treatment .
CONCLUSIONS	EMA401 was well tolerated by patients .
BACKGROUND	Spinifex Pharmaceuticals .

###24360008
BACKGROUND	It is not clear whether newly introduced cordless displacement systems are better able to manage gingiva than conventional systems .
OBJECTIVE	The purpose of this invivo study was to evaluate the gingival management ability of 4 different displacement methods with a standardized subgingival preparation finish line .
METHODS	The effects of 4 displacement techniques on gingival management and impression quality were evaluated by means of 6 evaluation criteria .
METHODS	A subgingival preparation finish line of between 1 and 2 mm was ensured , andthe buccal aspects of 252 ( n = 63 ) teeth were clinically assessed for ease of application , time spent , bleeding , remnants , and dilatation .
METHODS	The complete reproduction of the preparation finish line and the bubble and void formations on polyether impressions were also evaluated .
METHODS	The data were statistically analyzed with the ( 2 ) test ( = .05 ) .
METHODS	The Bonferroni correction was used to control Type I error for the pairwise comparison groups ( = .008 ) .
RESULTS	Statistically significant differences were found for all criteria among the groups ( P < .05 ) .
RESULTS	The nonimpregnated displacement cord group was the least effective group in terms of bleeding and impression quality ( P < .008 ) .
RESULTS	The aluminum chloride impregnated cord group and the displacement paste with cap group were found to be comparable in terms of remnants , dilatation , and impression quality ( P > .008 ) .
RESULTS	The retraction cap with paste group showed better results for ease of application , time spent , and bleeding than the aluminum chloride impregnated cord group ( P < .008 ) .
RESULTS	Although the group with aluminum chloride impregnated cord , displacement paste , and cap showed better results for dilatation , it was time consuming and difficult ( P < .008 ) .
CONCLUSIONS	Except for the nonimpregnated cord group , all of the groups were comparable and clinically useful , with perfect or acceptable impression qualities .

###25822648
BACKGROUND	Osteoarthritis is the most prevalent joint disease and a common cause of joint pain , functional loss , and disability .
BACKGROUND	Conventional treatments demonstrate only modest clinical benefits without lesion reversal .
BACKGROUND	Autologous mesenchymal stromal cell ( MSC ) treatments have shown feasibility , safety , and strong indications for clinical efficacy .
BACKGROUND	We performed a randomized , active control trial to assess the feasibility and safety of treating osteoarthritis with allogeneic MSCs , and we obtain information regarding the efficacy of this treatment .
METHODS	We randomized 30 patients with chronic knee pain unresponsive to conservative treatments and showing radiological evidence of osteoarthritis into 2 groups of 15 patients .
METHODS	The test group was treated with allogeneic bone marrow MSCs by intra-articular injection of 40 10 ( 6 ) cells .
METHODS	The control group received intra-articular hyaluronic acid ( 60 mg , single dose ) .
METHODS	Clinical outcomes were followed for 1 year and included evaluations of pain , disability , and quality of life .
METHODS	Articular cartilage quality was assessed by quantitative magnetic resonance imaging T2 mapping .
RESULTS	Feasibility and safety were confirmed and indications of clinical efficacy were identified .
RESULTS	The MSC-treated patients displayed significant improvement in algofunctional indices versus the active controls treated with hyaluronic acid .
RESULTS	Quantification of cartilage quality by T2 relaxation measurements showed a significant decrease in poor cartilage areas , with cartilage quality improvements in MSC-treated patients .
CONCLUSIONS	Allogeneic MSC therapy may be a valid alternative for the treatment of chronic knee osteoarthritis that is more logistically convenient than autologous MSC treatment .
CONCLUSIONS	The intervention is simple , does not require surgery , provides pain relief , and significantly improves cartilage quality .

###24253247
BACKGROUND	We aimed to evaluate treatment responses to atazanavir plus ritonavir ( ATV/r ) or efavirenz ( EFV ) in initial antiretroviral regimens among women and men , and determine if treatment outcomes differ by sex .
METHODS	We performed a randomized trial of open-label ATV/r or EFV combined with abacavir/lamivudine ( ABC/3TC ) or tenofovir/emtricitabine ( TDF/FTC ) in 1857 human immunodeficiency virus type 1-infected , treatment-naive persons enrolled between September 2005 and November 2007 at 59 sites in the United States and Puerto Rico .
METHODS	Associations of sex with 3 primary study endpoints of time to virologic failure , safety , and tolerability events were analyzed using Cox proportional hazards models .
METHODS	Model-based population pharmacokinetic analysis was performed using nonlinear mixed effects modeling ( NONMEM version VII ) .
RESULTS	Of 1857 participants , 322 were women .
RESULTS	Women assigned to ATV/r had a higher risk of virologic failure with either nucleoside reverse transcriptase inhibitor backbone than women assigned to EFV , or men assigned to ATV/r .
RESULTS	The effects of ATV/r and EFV upon safety and tolerability risk did not differ significantly by sex .
RESULTS	With ABC/3TC , women had a significantly higher ( 32 % ) safety risk compared to men ; with TDF/FTC , the safety risk was 20 % larger for women compared to men , but not statistically significant .
RESULTS	Women had slower ATV clearance and higher predose levels of ATV compared to men .
RESULTS	Self-reported adherence did not differ significantly by sex .
CONCLUSIONS	This is the first randomized clinical trial to identify a significantly earlier time to virologic failure in women randomized to ATV/r compared to women randomized to EFV .
CONCLUSIONS	This finding has important clinical implications given that boosted protease inhibitors are often favored over EFV in women of childbearing potential .
BACKGROUND	NCT00118898 .

###24284781
OBJECTIVE	This study investigated strategies that may increase the yield of drug resistance testing prior to starting antiretroviral therapy ( ART ) , and whether transmitted and polymorphic resistance-associated mutations ( RAMs ) correlated with virological outcomes .
METHODS	We carried out retrospective testing of baseline samples from patients entering the SENSE trial of first-line ART in Europe , Russia and Israel .
METHODS	Prior to randomization to etravirine or efavirenz plus two nucleos ( t ) ide reverse transcriptase inhibitors ( NRTIs ) , plasma samples underwent routine Sanger sequencing of HIV-1 RT and protease ( ( plasma ) SS ) in order to exclude patients with transmitted RAMs .
METHODS	Retrospectively , Sanger sequencing was repeated with HIV-1 DNA from baseline peripheral blood mononuclear cells ( PBMCSS ) ; baseline plasma samples were retested by allele-specific PCR targeting seven RT RAMs ( AS-PCR ) and ultra-deep RT sequencing ( UDS ) .
RESULTS	By ( plasma ) SS , 16/193 ( 8.3 % ) patients showed 1 transmitted RAM affecting the NRTIs ( 10/193 , 5.2 % ) , non-nucleoside reverse transcriptase inhibitors ( 4/193 , 2.1 % ) or protease inhibitors ( 2/193 , 1.0 % ) .
RESULTS	No additional RAMs were detected by AS-PCR ( n = 152 ) and UDS ( n = 24 ) ; PBMCSS ( n = 91 ) yielded two additional samples with one RAM each .
RESULTS	Over 48 weeks , 4/79 ( 5.1 % ) patients on etravirine and 7/78 ( 9.0 % ) on efavirenz experienced virological failure ; none had baseline RAMs .
RESULTS	Conversely , 11/79 ( 13.9 % ) patients randomized to etravirine had one polymorphic RAM from the etravirine score in baseline plasma ( V90I , V106I or E138A ) , without any impact on virological outcomes .
CONCLUSIONS	The detection of resistance increased marginally with PBMC testing but did not increase with sensitive plasma testing .
CONCLUSIONS	A careful consideration is required of the cost-effectiveness of different strategies for baseline HIV drug resistance testing .

###24378765
OBJECTIVE	This study aims to confirm the factor structure of the Menopause-Specific Quality of Life ( MENQOL ) questionnaire by using confirmatory factor analysis ( CFA ) and to determine whether improvements in menopause-specific health-related quality of life ( HRQOL ) observed with bazedoxifene ( BZA ) / conjugated estrogens ( CE ) relative to placebo are clinically meaningful .
METHODS	Postmenopausal women with seven or more moderate to severe hot flushes per day ( or 50 per wk ) received BZA 20 mg/CE 0.45 mg , BZA 20 mg/CE 0.625 mg , or placebo for 12 weeks .
METHODS	HRQOL and treatment satisfaction were evaluated using the MENQOL questionnaire and the Menopause Symptoms Treatment Satisfaction Questionnaire , respectively .
METHODS	The structure of the MENQOL questionnaire was evaluated using CFA .
METHODS	To estimate clinically important differences ( CIDs ) in HRQOL , we used a repeated-measures model to estimate changes in MENQOL domain and total scores using Menopause Symptoms Treatment Satisfaction Questionnaire items as anchors .
RESULTS	The CFA model fits the MENQOL data ( Bentler 's comparative fit index > 0.9 ) .
RESULTS	CID estimates ranged from 0.5 to 1.2 for the MENQOL domains and total score .
RESULTS	Change from baseline in MENQOL vasomotor domain score for BZA 20 mg/CE 0.45 mg and BZA 20 mg/CE 0.625 mg compared with placebo was greater than the estimated CID , as were changes in MENQOL physical domain and total scores for BZA 20 mg/CE 0.625 mg compared with placebo .
CONCLUSIONS	CFA confirms the factor structure of the MENQOL questionnaire .
CONCLUSIONS	Treatment with BZA/CE provides clinically meaningful improvements in HRQOL in a population of postmenopausal women with bothersome vasomotor symptoms .

###24417608
OBJECTIVE	In schizophrenia , the ability to adaptively infer the thoughts and feelings of others ( i.e. , social cognition ) is strongly associated with community functioning .
OBJECTIVE	Researchers have designed psychosocial interventions to improve social cognition with the aim of improving downstream social functioning .
OBJECTIVE	Social Cognition and Interaction Training ( SCIT ) is one such intervention .
OBJECTIVE	Previous research on SCIT has been promising , but has consisted largely of smaller trials with insufficient experimental control .
METHODS	Randomized , controlled trial .
METHODS	The current article reports on a controlled trial of 66 adults with schizophrenia randomized to receive either SCIT ( n = 33 ) , delivered in weekly group sessions , or treatment as usual ( n = 33 ) for 6 months .
METHODS	Participants completed assessments of social cognition , social functioning , neurocognition and symptoms at baseline , post-treatment , and 3-month follow-up .
RESULTS	Primary analyses suggest that SCIT may improve social functioning , negative symptoms , and possibly hostile attributional bias .
RESULTS	Post-hoc analyses suggest a dose-response effect .
CONCLUSIONS	Findings are discussed in the context of continuing to refine and improve social cognitive interventions for schizophrenia .
CONCLUSIONS	Social cognitive intervention is a feasible and promising approach to improving social functioning among individuals with schizophrenia-spectrum disorders .
CONCLUSIONS	Dose-response findings suggest that delivering social cognitive interventions with greater frequency may maximize their benefit to patients .
CONCLUSIONS	Research on social cognitive interventions is still young and effects from well-controlled trials have been inconsistent .
CONCLUSIONS	It is not yet clear which components of social cognitive training may be the key active ingredients .

###24281309
BACKGROUND	In the treatment of atopic dermatitis , pimecrolimus has high antipruritic effects .
OBJECTIVE	To investigate the efficacy of 1 % pimecrolimus cream in comparison to 1 % hydrocortisone cream in non-atopic prurigo nodularis ( PN ) .
METHODS	A randomized , controlled , double-blind study with intraindividual randomization was done in 30 patients ( 17 females , 13 males ; mean age 58.5 years ) with PN .
RESULTS	Pruritus intensity decreased significantly ( p < 0.001 ) on both treated sides as early as after 10 days of treatment ; scratch lesions improved ( p < 0.001 ) .
RESULTS	Quality of life as assessed by the Dermatology Life Quality Index improved significantly .
RESULTS	However , a significant advantage of pimecrolimus over hydrocortisone was not found .
CONCLUSIONS	The results suggest that the non-steroid pimecrolimus is an effective alternative for PN treatment .

###24230461
OBJECTIVE	The objective was to assess the feasibility and acceptability of nine positive psychology exercises delivered to patients hospitalized for suicidal thoughts or behaviors , and to secondarily explore the relative impact of the exercises .
METHODS	Participants admitted to a psychiatric unit for suicidal ideation or behavior completed daily positive psychology exercises while hospitalized .
METHODS	Likert-scale ratings of efficacy ( optimism , hopelessness , perceived utility ) and ease of completion were consolidated and compared across exercises using mixed models accounting for age , missing data and exercise order .
METHODS	Overall effects of exercise on efficacy and ease were also examined using mixed models .
RESULTS	Fifty-two ( 85.3 % ) of 61 participants completed at least one exercise , and 189/213 ( 88.7 % ) assigned exercises were completed .
RESULTS	There were overall effects of exercise on efficacy ( ( 2 ) = 19.39 ; P = .013 ) but not ease of completion ( ( 2 ) = 11.64 ; P = .17 ) , accounting for age , order and skipped exercises .
RESULTS	Effect ( Cohen 's d ) of exercise on both optimism and hopelessness was moderate for the majority of exercises .
RESULTS	Exercises related to gratitude and personal strengths ranked highest .
RESULTS	Both gratitude exercises had efficacy scores that were significantly ( P = .001 ) greater than the lowest-ranked exercise ( forgiveness ) .
CONCLUSIONS	In this exploratory project , positive psychology exercises delivered to suicidal inpatients were feasible and associated with short-term gains in clinically relevant outcomes .

###24909293
OBJECTIVE	To evaluate the efficacy and safety of the selective sodium glucose co-transporter 2 inhibitor dapagliflozin in Japanese patients with type 2 diabetes mellitus ( T2DM ) inadequately controlled by diet and exercise .
METHODS	Patients received placebo or dapagliflozin ( 5 or 10 mg ) once daily for 24 weeks .
METHODS	The primary outcome measure was change from baseline in glycated haemoglobin ( HbA1c ) .
RESULTS	Patients ( N = 261 ) had modestly elevated baseline HbA1c ( mean 7.5 % ) and most had mild or moderate renal impairment ( estimated glomerular filtration rate range 43-103 ml/min/1 .73 m ( 2 ) ) .
RESULTS	Greater reductions in mean HbA1c level were observed with dapagliflozin ( 5 mg , -0.41 % ; 10 mg , -0.45 % ) than with placebo ( -0.06 % ) at week 24 and these were greater in patients with higher baseline HbA1c levels .
RESULTS	Fasting plasma glucose ( FPG ) was also significantly reduced with dapagliflozin ( 5 mg , -8.6 mg/dl ; 10 mg , -13.7 mg/dl ) compared with placebo ( +5.8 mg/dl ) .
RESULTS	Dapagliflozin significantly reduced body weight ( 5 mg , -2.13 kg ; 10 mg , -2.22 kg ) compared with placebo ( -0.84 kg ) .
RESULTS	Overall , 47.7 and 64.8 % of patients with dapagliflozin 5 and 10 mg , respectively , and 51.7 % with placebo experienced 1 adverse event , mostly mild or moderate , and unrelated to study treatment .
RESULTS	Two patients on dapagliflozin 10 mg reported hypoglycaemia .
RESULTS	Four patients across all groups reported events suggestive of genital infection and four of urinary tract infection .
RESULTS	No events of pyelonephritis were reported .
CONCLUSIONS	Dapagliflozin ( 5 and 10 mg ) was well tolerated and effective in reducing HbA1c , FPG and body weight over 24 weeks in Japanese patients with T2DM inadequately controlled by diet and exercise .

###25957224
BACKGROUND	The Clopidogrel in High-risk patients with Acute Non-disabling Cerebrovascular Events ( CHANCE ) trial showed that the combined treatment of clopidogrel and aspirin decreases the 90-day risk of stroke without increasing hemorrhage in comparison with aspirin alone , but provided insufficient data to establish whether the benefit persisted over a longer period of time beyond the trial termination .
BACKGROUND	We report the 1-year follow-up outcomes of this trial .
RESULTS	The trial was a randomized , double-blind , placebo-controlled trial conducted at 114 centers in China .
RESULTS	We randomly assigned 5170 patients within 24 hours after onset of minor stroke or high-risk transient ischemic attack to clopidogrel-aspirin therapy ( loading dose of 300 mg of clopidogrel on day 1 , followed by 75 mg of clopidogrel per day for 90 days , plus 75 mg of aspirin per day for the first 21 days ) or to the aspirin-alone group ( 75 mg/d for 90 days ) .
RESULTS	The primary outcome was stroke event ( ischemic or hemorrhagic ) during 1-year follow-up .
RESULTS	Differences in outcomes between groups were assessed by using the Cox proportional hazards model .
RESULTS	Stroke occurred in 275 ( 10.6 % ) patients in the clopidogrel-aspirin group , in comparison with 362 ( 14.0 % ) patients in the aspirin group ( hazard ratio , 0.78 ; 95 % confidence interval , 0.65-0 .93 ; P = 0.006 ) .
RESULTS	Moderate or severe hemorrhage occurred in 7 ( 0.3 % ) patients in the clopidogrel-aspirin group and in 9 ( 0.4 % ) patients in the aspirin group ( P = 0.44 ) .
CONCLUSIONS	The early benefit of clopidogrel-aspirin treatment in reducing the risk of subsequent stroke persisted for the duration of 1-year of follow-up .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00979589 .

###25241756
BACKGROUND	Schizophrenia ( SZ ) is a chronic illness that is treated symptomatically .
BACKGROUND	Cognitive dysfunction is a core feature of SZ that is relatively intractable to pharmacotherapy .
BACKGROUND	Yoga can improve cognitive function among healthy individuals .
BACKGROUND	A recent open trial indicated significant benefits of yoga training ( YT ) in conjunction with conventional pharmacotherapy among patients with SZ .
OBJECTIVE	To describe the protocol for an ongoing randomised controlled trial designed to test whether the reported beneficial effects of YT on cognitive function among SZ patients can be replicated .
OBJECTIVE	Secondarily , the effects of YT on daily functioning living skills are evaluated .
METHODS	Consenting patients with SZ receive routine clinical treatment and are randomised to adjunctive YT , adjunctive physical exercise ( PE ) or treatment as usual ( proposed N = 234 total , N = 78 in each group ) .
METHODS	The trial involves YT or PE 5 days a week and lasts 3 weeks .
METHODS	Participants are evaluated thrice over 6 months .
METHODS	Cognitive functions measured by Trail Making Test , University of Pennsylvania Neurocognitive Computerised Battery were primary outcome measures while clinical severity and daily functioning measured by Independent Living Skills Survey were secondary outcome measures .
RESULTS	A total of 309 participants have been randomised as of 31 August 2013 , which exceeded beyond 294 proposed after attrition .
RESULTS	Once participants begin YT or PE they generally complete the protocol .
RESULTS	No injuries have been reported .
CONCLUSIONS	Short term YT is feasible and acceptable to Indian SZ patients .
CONCLUSIONS	If beneficial effects of YT are detected , it will provide a novel adjunctive cognitive remediation strategy for SZ patients .

###25318186
OBJECTIVE	To evaluate the efficacy and safety of intravitreal injections of pegaptanib sodium in subjects with diabetic macular edema ( DME ) .
METHODS	There were 243 subjects with DME who were randomized to receive , every 6 weeks , either an intravitreal injection of pegaptanib sodium or a sham injection .
METHODS	The study was double-masked for the first 24 weeks , and then an open label phase continued to week 54 .
METHODS	The primary efficacy endpoint was evaluated at week 24 , and safety was assessed throughout the 54 weeks .
CONCLUSIONS	The proportion of subjects who experienced more than 10 letters improvement of visual acuity in ETDRS chart from baseline to week 24 was statistically significantly greater ( p-value = 0.0003 ) in the pegaptanib sodium group , 20.3 % , than in the sham group , 5.0 % .
CONCLUSIONS	The incidence of treatment-related adverse events was similar between the treatment groups ( pegaptanib sodium group : 10.6 % , sham group : 10.0 % ) .
CONCLUSIONS	The reported adverse events were mainly mild or moderate ophthalmic events and related to the injection procedure .
CONCLUSIONS	During open-label phase up to 54 weeks , no new safety concerns were identified compared with the double-masked phase .
CONCLUSIONS	However , in light of the issue concerning proper maintenance of masking of the study treatments , the study was not considered as a well-controlled , double-masked study .

###26488691
BACKGROUND	More than 670,000 total knee replacements are performed annually in the United States ; however , high-quality evidence to support the effectiveness of the procedure , as compared with nonsurgical interventions , is lacking .
METHODS	In this randomized , controlled trial , we enrolled 100 patients with moderate-to-severe knee osteoarthritis who were eligible for unilateral total knee replacement .
METHODS	Patients were randomly assigned to undergo total knee replacement followed by 12 weeks of nonsurgical treatment ( total-knee-replacement group ) or to receive only the 12 weeks of nonsurgical treatment ( nonsurgical-treatment group ) , which was delivered by physiotherapists and dietitians and consisted of exercise , education , dietary advice , use of insoles , and pain medication .
METHODS	The primary outcome was the change from baseline to 12 months in the mean score on four Knee Injury and Osteoarthritis Outcome Score subscales , covering pain , symptoms , activities of daily living , and quality of life ( KOOS4 ) ; scores range from 0 ( worst ) to 100 ( best ) .
RESULTS	A total of 95 patients completed the 12-month follow-up assessment .
RESULTS	In the nonsurgical-treatment group , 13 patients ( 26 % ) underwent total knee replacement before the 12-month follow-up ; in the total-knee-replacement group , 1 patient ( 2 % ) received only nonsurgical treatment .
RESULTS	In the intention-to-treat analysis , the total-knee-replacement group had greater improvement in the KOOS4 score than did the nonsurgical-treatment group ( 32.5 vs. 16.0 ; adjusted mean difference , 15.8 [ 95 % confidence interval , 10.0 to 21.5 ] ) .
RESULTS	The total-knee-replacement group had a higher number of serious adverse events than did the nonsurgical-treatment group ( 24 vs. 6 , P = 0.005 ) .
CONCLUSIONS	In patients with knee osteoarthritis who were eligible for unilateral total knee replacement , treatment with total knee replacement followed by nonsurgical treatment resulted in greater pain relief and functional improvement after 12 months than did nonsurgical treatment alone .
CONCLUSIONS	However , total knee replacement was associated with a higher number of serious adverse events than was nonsurgical treatment , and most patients who were assigned to receive nonsurgical treatment alone did not undergo total knee replacement before the 12-month follow-up .
CONCLUSIONS	( Funded by the Obel Family Foundation and others ; MEDIC ClinicalTrials.gov number , NCT01410409 . )

###25125300
BACKGROUND	It is not known whether high-risk plaque , as detected by coronary computed tomography angiography ( CTA ) , permits improved early diagnosis of acute coronary syndromes ( ACS ) independently to the presence of significant coronary artery disease ( CAD ) in patients with acute chest pain .
OBJECTIVE	The primary aim of this study was to determine whether high-risk plaque features , as detected by CTA in the emergency department ( ED ) , may improve diagnostic certainty of ACS independently and incrementally to the presence of significant CAD and clinical risk assessment in patients with acute chest pain but without objective evidence of myocardial ischemia or myocardial infarction ( MI ) .
METHODS	We included patients randomized to the coronary CTA arm of the ROMICAT-II ( Rule Out Myocardial Infarction/Ischemia Using Computer-Assisted Tomography II ) trial .
METHODS	Readers assessed coronary CTA qualitatively for the presence of nonobstructive CAD ( 1 % to 49 % stenosis ) , significant CAD ( 50 % or 70 % stenosis ) , and the presence of at least 1 of the high-risk plaque features ( positive remodeling , low < 30 Hounsfield units plaque , napkin-ring sign , spotty calcium ) .
METHODS	In logistic regression analysis , we determined the association of high-risk plaque with ACS ( MI or unstable angina pectoris ) during the index hospitalization and whether this was independent of significant CAD and clinical risk assessment .
RESULTS	Overall , 37 of 472 patients who underwent coronary CTA with diagnostic image quality ( mean age 53.9 8.0 years ; 52.8 % men ) had ACS ( 7.8 % ; MI n = 5 ; unstable angina pectoris n = 32 ) .
RESULTS	CAD was present in 262 patients ( 55.5 % ; nonobstructive CAD in 217 patients [ 46.0 % ] and significant CAD with 50 % stenosis in 45 patients [ 9.5 % ] ) .
RESULTS	High-risk plaques were more frequent in patients with ACS and remained a significant predictor of ACS ( odds ratio [ OR ] : 8.9 ; 95 % CI : 1.8 to 43.3 ; p = 0.006 ) after adjustment for 50 % stenosis ( OR : 38.6 ; 95 % CI : 14.2 to 104.7 ; p < 0.001 ) and clinical risk assessment ( age , sex , number of cardiovascular risk factors ) .
RESULTS	Similar results were observed after adjustment for 70 % stenosis .
CONCLUSIONS	In patients presenting to the ED with acute chest pain but negative initial electrocardiogram and troponin , presence of high-risk plaques on coronary CTA increased the likelihood of ACS independent of significant CAD and clinical risk assessment ( age , sex , and number of cardiovascular risk factors ) .
CONCLUSIONS	( Multicenter Study to Rule Out Myocardial Infarction by Cardiac Computed Tomography [ ROMICAT-II ] ; NCT01084239 ) .

###25169652
OBJECTIVE	Impaired arousal from sleep has been implicated in sudden infant death syndrome ( SIDS ) .
OBJECTIVE	Sleeping in the prone position is a major risk factor for SIDS .
OBJECTIVE	Epidemiological studies have shown that pacifier use decreases the risk of SIDS , even when infants sleep prone .
OBJECTIVE	We examined spontaneous arousability in infants slept prone and supine over the first 6 months of life and hypothesised that spontaneous arousals would be increased in pacifier users , particularly in the prone position .
METHODS	Healthy term infants ( n = 30 ) were studied on three occasions over the first 6 months after birth .
METHODS	Spontaneous cortical arousals and subcortical activations were scored and converted into frequency per hour of sleep .
RESULTS	There was no effect of pacifier use on total time spent sleeping or awake or the number of spontaneous awakenings at any age .
RESULTS	There was also no effect of pacifier use on the frequency or duration of the total number of spontaneous arousals or on cortical arousals and subcortical activations .
CONCLUSIONS	Pacifier use did not alter infant spontaneous arousability at any of the three ages studied , in either the prone or supine sleeping position .
CONCLUSIONS	Any preventative effect of pacifiers for SIDS may be through physiological mechanisms other than increased arousability .

###24324331
BACKGROUND	Restorative home care services are short-term and aimed at maximizing a person 's ability to live independently .
BACKGROUND	They are multidimensional and often include an exercise program to improve strength , mobility , and balance .
BACKGROUND	The aim of this study was to determine whether a lifestyle exercise program would be undertaken more often and result in greater functional gains than the current structured exercise program delivered as part of a restorative home care service for older adults .
METHODS	A pragmatic randomized controlled trial was conducted in an organization with an established restorative home care service .
METHODS	Individuals who were to have an exercise program as part of their service were randomized to receive either a lifestyle and functional exercise program called LiFE ( as this was a new program , the intervention ) or the structured exercise program currently being used in the service ( control ) .
METHODS	Exercise data collected by the individuals throughout and pre and post intervention testing was used to measure balance , strength , mobility , falls efficacy , vitality , function , and disability .
RESULTS	There was no difference between the groups in the amounts of exercise undertaken during the 8-week intervention period .
RESULTS	Outcome measurement indicated that the LiFE program was as effective , and on 40 % of the measures , more effective , than the structured exercise program .
CONCLUSIONS	Organizations delivering restorative home care services that include an exercise component should consider whether LiFE rather than the exercise program they are currently using could help their clients achieve better outcomes .

###25187211
BACKGROUND	Despite the life threatening nature of an HIV diagnosis and the multidimensional problems experienced by this patient population during antiretroviral therapy , the effectiveness of a palliative care approach for HIV positive patients on ART is as yet unknown .
RESULTS	A randomised controlled trial ( RCT ) was conducted in a sample of 120 HIV positive patients on ART in an urban clinic in Mombasa , Kenya .
RESULTS	The intervention was a minimum of seven sessions of multidimensional , person-centred care , given by HIV nurses trained in the palliative care approach over a period of 5months .
RESULTS	Rates of recruitment and refusal , the effectiveness of the randomisation procedure , trial follow-up and attrition and extent of missing data are reported .120 patients ( 60 randomised to control arm , 60 randomised to intervention arm ) were recruited over 5.5 months , with a refusal rate of 55.7 % .
RESULTS	During the study period , three participants died from cancer , three withdrew ( two moved away and one withdrew due to time constraints ) .
RESULTS	All of these patients were in the intervention arm : details are reported .
RESULTS	There were five additional missing monthly interviews in both the control and intervention study arm , bringing the total of missing data to 26 data points ( 4.3 % ) .
CONCLUSIONS	The quality and implications of these data are discussed extensively and openly , including the effect of full and ethical consent procedures , respondent burden , HIV stigma , accurate randomisation , patient safety and the impact of the intervention .
CONCLUSIONS	Data on recruitment randomisation , attrition and missing data in clinical trials should be routinely reported , in conjunction with the now established practice of publishing study protocols to enhance research integrity , transparency and quality .
CONCLUSIONS	Transparency is especially important in cross cultural settings , in which the sources of funding and trial design are often not based in the country of data collection .
CONCLUSIONS	Findings reported can be used to inform future RCTs in this area .
BACKGROUND	Clinicaltrials.gov NCT01608802 .

###25327872
OBJECTIVE	To evaluate the efficacy of inducing labour using a double-balloon catheter and oral misoprostol sequentially , in comparison with oral misoprostol alone .
METHODS	A multicentre randomised controlled trial .
METHODS	Five hospitals in Germany .
METHODS	A total of 326 pregnant women with an unfavourable cervix undergoing labour induction at term .
METHODS	Women were randomly assigned according to a computer-generated allocation sequence to sequential use of double-balloon catheter and oral misoprostol ( study group ) or oral misoprostol alone ( control group ) .
METHODS	In the study group , the double-balloon catheter was used the first day before starting oral misoprostol the second day .
METHODS	The primary outcome measure was the induction-to-delivery interval , and a further outcome parameter was delivery within 48 hours .
RESULTS	The median times for induction of labour until delivery were 32.4 hours in the study group and 22.5 hours in the control group ( P = 0.004 ) .
RESULTS	This difference was not seen when evaluating according to parity ( nulliparous , P = 0.19 ; parous , P = 0.06 ) .
RESULTS	The rate of vaginal delivery within 48 hours did not differ between both groups .
RESULTS	The number of applications of misoprostol ( two versus three , P < 0.001 ) and the dose of misoprostol used was lower in the study group ( 100 versus 200 g , P < 0.001 ) .
RESULTS	In the study group , there were more Apgar scores of < 7 at 5 minutes ( 8 versus 1 , P = 0.04 ) .
CONCLUSIONS	The use of a double-balloon catheter on the first day , before starting oral misoprostol on the second day , did not improve the induction to delivery interval and the rate of delivery within 48 hours , in comparison with oral misoprostol alone .

###25981810
BACKGROUND	Patients with advanced basal cell carcinoma have limited treatment options .
BACKGROUND	Hedgehog pathway signalling is aberrantly activated in around 95 % of tumours .
BACKGROUND	We assessed the antitumour activity of sonidegib , a Hedgehog signalling inhibitor , in patients with advanced basal cell carcinoma .
METHODS	BOLT is an ongoing multicentre , randomised , double-blind , phase 2 trial .
METHODS	Eligible patients had locally advanced basal cell carcinoma not amenable to curative surgery or radiation or metastatic basal cell carcinoma .
METHODS	Patients were randomised via an automated system in a 1:2 ratio to receive 200 mg or 800 mg oral sonidegib daily , stratified by disease , histological subtype , and geographical region .
METHODS	The primary endpoint was the proportion of patients who achieved an objective response , assessed in the primary efficacy analysis population ( patients with fully assessable locally advanced disease and all those with metastatic disease ) with data collected up to 6 months after randomisation of the last patient .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01327053 .
RESULTS	Between July 20 , 2011 , and Jan 10 , 2013 , we enrolled 230 patients , 79 in the 200 mg sonidegib group , and 151 in the 800 mg sonidegib group .
RESULTS	Median follow-up was 139 months ( IQR 101-173 ) .
RESULTS	In the primary efficacy analysis population , 20 ( 36 % , 95 % CI 24-50 ) of 55 patients receiving 200 mg sonidegib and 39 ( 34 % , 25-43 ) of 116 receiving 800 mg sonidegib achieved an objective response .
RESULTS	In the 200 mg sonidegib group , 18 ( 43 % , 95 % CI 28-59 ) patients who achieved an objective response , as assessed by central review , were noted among the 42 with locally advanced basal cell carcinoma and two ( 15 % , 2-45 ) among the 13 with metastatic disease .
RESULTS	In the 800 mg group , 35 ( 38 % , 95 % CI 28-48 ) of 93 patients with locally advanced disease had an objective response , as assessed by central review , as did four ( 17 % , 5-39 ) of 23 with metastatic disease .
RESULTS	Fewer adverse events leading to dose interruptions or reductions ( 25 [ 32 % ] of 79 patients vs 90 [ 60 % ] of 150 ) or treatment discontinuation ( 17 [ 22 % ] vs 54 [ 36 % ] ) occurred in patients in the 200 mg group than in the 800 mg group .
RESULTS	The most common grade 3-4 adverse events were raised creatine kinase ( five [ 6 % ] in the 200 mg group vs 19 [ 13 % ] in the 800 mg group ) and lipase concentration ( four [ 5 % ] vs eight [ 5 % ] ) .
RESULTS	Serious adverse events occurred in 11 ( 14 % ) of 79 patients in the 200 mg group and 45 ( 30 % ) of 150 patients in the 800 mg group .
CONCLUSIONS	The benefit-to-risk profile of 200 mg sonidegib might offer a new treatment option for patients with advanced basal cell carcinoma , a population that is difficult to treat .
BACKGROUND	Novartis Pharmaceuticals Corporation .

###25004803
BACKGROUND	The recent convergence between technology and medicine is offering innovative methods and tools for behavioral health care .
BACKGROUND	Among these , an emerging approach is the use of virtual reality ( VR ) within exposure-based protocols for anxiety disorders , and in particular posttraumatic stress disorder .
BACKGROUND	However , no systematically tested VR protocols are available for the management of psychological stress .
OBJECTIVE	Our goal was to evaluate the efficacy of a new technological paradigm , Interreality , for the management and prevention of psychological stress .
OBJECTIVE	The main feature of Interreality is a twofold link between the virtual and the real world achieved through experiential virtual scenarios ( fully controlled by the therapist , used to learn coping skills and improve self-efficacy ) with real-time monitoring and support ( identifying critical situations and assessing clinical change ) using advanced technologies ( virtual worlds , wearable biosensors , and smartphones ) .
METHODS	The study was designed as a block randomized controlled trial involving 121 participants recruited from two different worker populations-teachers and nurses-that are highly exposed to psychological stress .
METHODS	Participants were a sample of teachers recruited in Milan ( Block 1 : n = 61 ) and a sample of nurses recruited in Messina , Italy ( Block 2 : n = 60 ) .
METHODS	Participants within each block were randomly assigned to the ( 1 ) Experimental Group ( EG ) : n = 40 ; B1 = 20 , B2 = 20 , which received a 5-week treatment based on the Interreality paradigm ; ( 2 ) Control Group ( CG ) : n = 42 ; B1 = 22 , B2 = 20 , which received a 5-week traditional stress management training based on cognitive behavioral therapy ( CBT ) ; and ( 3 ) the Wait-List group ( WL ) : n = 39 , B1 = 19 , B2 = 20 , which was reassessed and compared with the two other groups 5 weeks after the initial evaluation .
RESULTS	Although both treatments were able to significantly reduce perceived stress better than WL , only EG participants reported a significant reduction ( EG = 12 % vs. CG = 0.5 % ) in chronic `` trait '' anxiety .
RESULTS	A similar pattern was found for coping skills : both treatments were able to significantly increase most coping skills , but only EG participants reported a significant increase ( EG = 14 % vs CG = 0.3 % ) in the Emotional Support skill .
CONCLUSIONS	Our findings provide initial evidence that the Interreality protocol yields better outcomes than the traditionally accepted gold standard for psychological stress treatment : CBT .
CONCLUSIONS	Consequently , these findings constitute a sound foundation and rationale for the importance of continuing future research in technology-enhanced protocols for psychological stress management .
BACKGROUND	ClinicalTrials.gov : NCT01683617 ; http://clinicaltrials.gov/show/NCT01683617 ( Archived by WebCite at http://www.webcitation.org/6QnziHv3h ) .

###24334642
OBJECTIVE	Patient assessments of disease activity ( PtGA ) and general health ( GH ) measured by visual analog scale ( VAS ) are widely used in rheumatoid arthritis ( RA ) clinical practice and research .
OBJECTIVE	These require comprehension of the question 's wording and translation of disease activity onto a written VAS , which is problematic for patients with limited health literacy ( HL ) or difficulty completing forms .
OBJECTIVE	This study 's objective was to validate verbally administered versions of patient assessments and identify factors that might explain discrepancies between verbal and written measures .
METHODS	We enrolled patients with RA at the Denver Health rheumatology clinic ( n = 300 ) .
METHODS	Subjects were randomized to complete the traditional written PtGA and GH and one of the verbal assessments .
METHODS	Subjects provided a verbal numeric response after reading the question , having the question read to them in person , or hearing the question over the phone .
METHODS	Spearman and Lin correlations comparing written and verbal assessments were determined .
METHODS	Multivariate logistic regression was performed to explain any discrepancies .
RESULTS	The instruments administered verbally in-person showed good , but not excellent , correlation with traditional written VAS forms ( Spearman coefficients 0.59 to 0.70 ; p < 0.001 for all correlations ) .
RESULTS	Twenty-three percent of subjects were unable to complete 1 of the written VAS assessments without assistance .
RESULTS	HL predicted missing written data and discrepancies between verbal and written assessments ( p < 0.05 for all correlations ) .
CONCLUSIONS	Providers should use verbal versions of PtGA and GH with caution while caring for patients unable to complete traditional written version .
CONCLUSIONS	Limited HL is widely prevalent and a barrier to obtaining patient-oriented data .

###24389523
OBJECTIVE	Concomitant type 2 diabetes ( T2D ) and metabolic syndrome exacerbates mortality risk ; yet , few studies have examined the effect of combining ( AER + RES ) aerobic ( AER ) and resistance ( RES ) training for individuals with T2D and metabolic syndrome .
METHODS	We examined AER , RES , and AER + RES training ( 9 months ) commensurate with physical activity guidelines in individuals with T2D ( n = 262 ; 63 % female , 44 % black ) .
METHODS	Primary outcomes were change in , and prevalence of , metabolic syndrome score at follow-up ( mean and 95 % confidence interval [ CI ] ) .
METHODS	Secondary outcomes included maximal cardiorespiratory fitness ( VO2peak ) and estimated METs from time-to-exhaustion ( TTE ) and exercise efficiency calculated as the slope of the line between ventilatory threshold , respiratory compensation , and maximal fitness .
METHODS	General linear models and bootstrapped Spearman correlations were used to examine changes in metabolic syndrome associated with training primary and secondary outcome variables .
RESULTS	We observed a significant decrease in metabolic syndrome scores ( P for trend = 0.003 ) for AER ( -0.59 , 95 % CI = -1.00 to -0.21 ) and AER + RES ( -0.79 , 95 % CI = -1.40 to -0.35 ) , both being significant ( P 0.02 ) versus control ( 0.26 , 95 % CI = -0.58 to 0.40 ) and RES ( -0.13 , 95 % CI = -1.00 to 0.24 ) .
RESULTS	This led to a reduction in metabolic syndrome prevalence for the AER ( 56 % vs 43 % ) and AER + RES ( 55 % vs 46 % ) groups between baseline and follow-up .
RESULTS	The observed decrease in metabolic syndrome was mediated by significant improvements in exercise efficiency for the AER and AER + RES training groups ( P < 0.05 ) , which was more strongly related to TTE ( 25 % -30 % ; r = -0.38 , 95 % CI = -0.55 to -0.19 ) than VO2peak ( 5 % -6 % ; r = -0.24 , 95 % CI = -0.45 to -0.01 ) .
CONCLUSIONS	AER and AER + RES training significantly improved metabolic syndrome scores and prevalence in patients with T2D .
CONCLUSIONS	These improvements appear to be associated with improved exercise efficiency and are more strongly related to improved TTE versus VO2peak .

###24612455
BACKGROUND	The pathophysiology of erectile dysfunction ( ED ) may be vasculogenic , hormonal , anatomical , neurogenic , drug-induced and/or psychogenic in origin .
BACKGROUND	Neuropathic pain ( NP ) may facilitate ED , because it is frequently associated with anxiety , depression , and its drug , pregabalin , may also contribute ED .
OBJECTIVE	The objective of this study was to determine whether pregabalin treatment for patients with neuropathic pain promotes erectile dysfunction .
METHODS	The study sample consisted of a total of 102 male subjects that were subdivided into three groups .
METHODS	Group 1 patients ( n = 31 ) had a pre-existing diagnosis of NP and was treated with 300mg/day of pregabalin for at least 3 months .
METHODS	Group 2 patients ( n = 34 ) were diagnosed with NP for at least 3 months ; however , neither were they treated with pregabalin nor did they received physical therapy throughout the study .
METHODS	Lastly , healthy age-matched control subjects comprised group 3 ( n = 37 ) .
METHODS	Patients in all groups completed the International Index for Erectile Function ( IIEF ) questionnaire .
RESULTS	Mean age and mean body mass index did not differ significantly between each of the three groups .
RESULTS	The cause of NP and the mean duration of having a diagnosis of NP did not differ significantly in groups 1 and 2 .
RESULTS	However , IIEF scores were significantly lower for group 1 when compared to group 2 in terms of erectile function , orgasmic function , overall satisfaction and total score .
RESULTS	Yet groups 1 and 2 did not diverge significantly in the intercourse satisfaction and sexual desire scores .
RESULTS	Overall IIEF scores for group 3 were significantly higher than those of group 2 except for mean erectile function scores .
CONCLUSIONS	Taking pregabalin for the treatment of neuropathic pain poses an increased risk for developing ED in male patients .
CONCLUSIONS	Thus , clinicians prescribing pregabalin to patients diagnosed with neuropathic pain should assess for ED before and during treatment with this medication .

###25632744
OBJECTIVE	To study the effect of Zhibai Dihuang Pill ( ZBDHP ) on urokinase-type plasminogen activator ( uPA ) and sperm quality in ureaplasma urealyticum ( Uu ) infection infertile patients .
METHODS	Recruited were 80 infertility patients with Uu infection at Andriatrics Clinics and Department of Reproduction , including 130 cases of positive Uu semen and 50 cases of negative Uu semen .
METHODS	Patients with positive Uu semen were randomly assigned to the observation group ( 72 cases ) and the control group ( 58 cases ) according to the visit sequence .
METHODS	All patients took antibiotics for 2 weeks .
METHODS	Patients in the observation group additionally took ZBDHP , 6 g each time , twice daily .
METHODS	Those in the control group additionally took Vit E ( 100 mg each time , twice per day ) and ATP ( 40 mg each time , twice per day ) .
METHODS	The therapeutic course for all was 90 days .
METHODS	Semen parameters and uPA contents of the sperm membrane were detected and comparatively analyzed .
RESULTS	The sperm membrane uPA content , the sperm motility , the sperm viability , and the percentage of normal morphology sperm in Uu positive infected patients were lower than those in Uu negative infected patients with statistical difference ( P < 0.05 ) , but with no significant difference in the sperm density between the two groups ( P > 0.05 ) .
RESULTS	There was no statistical difference in pre-treatment sperm membrane uPA contents and sperm parameters between the two groups ( P > 0.05 ) .
RESULTS	Compared with before treatment in the same group , the sperm membrane uPA content , the sperm motility , the sperm viability , and the percentage of normal morphology sperm obviously increased in the two groups with statistical difference ( P < 0.05 ) .
RESULTS	After treatment , the sperm membrane uPA content increased more obviously in the observation group , with statistical difference when compared with the control group ( P < 0.05 ) .
CONCLUSIONS	Infection with Uu leads to decreased uPA content of sperm membrance and the sperm motility .
CONCLUSIONS	ZBDHP could effectively treat Uu infected infertility possibly through fighting against Uu damaged sperm membrane and make the sperm membrane uPA content return to normal , and elevate the fertilizability of sperms .

###25112082
OBJECTIVE	To observe the impacts on the muscle strength in the patients of stroke-induced acroparalysis treated with Xunjingcuiqi needling technique .
METHODS	One hundred patients were randomized into a Xunjingcuiqi group and a routine acupuncture group , 50 cases in each group .
METHODS	In the routine acupuncture group , the routine acupuncture technique was adopted at the main acupoints , such as Shangxing ( GV 23 ) , Baihui ( GV 20 ) , Dicang ( ST 4 ) , Quchi ( LI 11 ) , Huantiao ( GB 30 ) and Zusanli ( ST 36 ) , etc. .
METHODS	In Xunjingcuiqi group , on the basis of the routine acupuncture technique , Xunjingcuiqi needling technique ( pricking technique was quickly applied with the filiform needle along the running course of meridian to promote the conduction of meridian qi ) was added .
METHODS	For the patients being hard to feel the needling sensation and with the muscle strength of 0 to 1 degree , Dongzhencuiqi technique was supplemented at shu-stream points of yang meridians ( after qi arrival , the needling manipulation with limb movement was given to promote the conduction of meridian qi ) .
METHODS	The treatment was given once every day in the two groups .
METHODS	Ten treatments made one session .
METHODS	Three sessions of treatment were required .
METHODS	At the end of each session treatment , the muscle strength and clinical efficacy were assessed .
RESULTS	In the 1st , 2nd and 3rd sessions of treatment , 20 , 24 and 36 cases achieved the 3 to 5 degrees muscle strength in Xunjingcuiqi group , respectively ; and 6 , 10 and 15 cases achieved the 3 to 5 degrees muscle strength in the routine acupuncture group .
RESULTS	The differences were significant statistically in comparison of the two groups ( P < 0.01 , P < 0.05 ) .
RESULTS	The markably effective rates were 60.0 % ( 30/50 ) , 64.0 % ( 32/50 ) and 70.0 % ( 35/50 ) after the 1st , 2nd and 3rd sessions of treatment in Xunjingcuiqi group , respectively ; and those were 38.0 % ( 19/50 ) , 44.0 % ( 22/50 ) and 46.0 % ( 23/50 ) in the routine acupuncture group , respectively .
RESULTS	The differences were significant in the 1st and 3rd sessions of treatment between the two groups ( both P < 0.05 ) .
CONCLUSIONS	Xunjingcuiqi needling technique combined with routine acupuncture achieves the apparent superior efficacy on acroparalysis induced by ischemic stroke as compared with the simple routine acupuncture .
CONCLUSIONS	Xunjingcuiqi needling technique obviously improves muscle strength and shortens the duration of sickness .

###24528930
OBJECTIVE	To assess the level of evidence-based drug prescribing for acute coronary syndrome ( ACS ) at discharge from Western Australian ( WA ) hospitals and determine predictors of such prescribing in Aboriginal and non-Aboriginal patients .
METHODS	All Aboriginal ( 2002-2004 ) and a random sample of non-Aboriginal ( 2003 ) hospital admissions with a principal diagnosis of ACS were extracted from the WA Hospital Morbidity Data Collection of WA Data Linkage System .
METHODS	Clinical information , history of co-morbidities and drugs were collected from medical notes by trained data collectors .
METHODS	Evidence-based prescribing ( EBP ) was defined as prescribing of aspirin , statin and beta-blocker or angiotensin-converting enzyme inhibitor/angiotensin II antagonist .
RESULTS	Records for 1717 ACS patients discharged alive from hospitals were reviewed .
RESULTS	The majority of patients ( 71 % ) had EBP , and there was no significant difference between Aboriginal and non-Aboriginal patients ( 70 % vs 71 % , P = 0.36 ) .
RESULTS	Conversely , a significantly higher proportion of Aboriginal patients had none of the drugs prescribed compared with non-Aboriginal patients ( 11 % vs 7 % , P < 0.01 ) .
RESULTS	EBP for ACS was independently associated with male sex ( odds ratio ( OR ) 1.63 , 95 % confidence interval ( CI ) 1.26-2 .11 ) , previous admission for ACS ( OR 1.83 , 95 % CI 1.39-2 .42 ) and diabetes ( OR 1.36 , 95 % CI 1.04-1 .79 ) .
RESULTS	However , ACS patients living in regional and remote areas , attending district or private hospitals , or with a history of chronic obstructive pulmonary disease were significantly less likely to have ACS drugs prescribed at discharge .
CONCLUSIONS	Opportunity exists to improve prescribing of recommended drugs for ACS patients at discharge from WA hospitals in both Aboriginal and non-Aboriginal patients .
CONCLUSIONS	Attention regarding pharmaceutical management post-ACS is particularly required for patients from rural and remote areas , and those attending district and private hospitals .

###25218264
BACKGROUND	Wound cleansing should create an optimal healing environment by removing excess debris , exudates , foreign and necrotic material which are commonly present in the wounds that heal by secondary intention .
BACKGROUND	At present , there is no research evidence for whether pressurised irrigation has better wound healing outcomes compared with conventional swabbing practice in cleansing wound .
OBJECTIVE	This study investigated the differences between pressurised irrigation and swabbing method in cleansing wounds that healed by secondary intention in relation to wound healing outcomes and cost-effectiveness .
METHODS	Multicentre , prospective , randomised controlled trial .
METHODS	The study took place in four General Outpatient Clinics in Hong Kong .
METHODS	Two hundred and fifty six patients with wounds healing by secondary intention were randomly assigned by having a staff independent of the study opening a serially numbered , opaque and sealed envelope to either pressurised irrigation ( n = 122 ) or swabbing ( n = 134 ) .
METHODS	Staff undertaking study-related assessments was blinded to treatment assignment .
METHODS	Patients ' wounds were followed up for 6 weeks or earlier if wounds had healed to determine wound healing , infection , symptoms , satisfaction , and cost effectiveness .
METHODS	The primary outcome was time-to-wound healing .
METHODS	Patients were analysed according to their treatment allocation .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01885273 .
RESULTS	Intention-to-treat analysis showed that pressurised irrigation group was associated with a shorter median time-to-wound healing than swabbing group [ 9.0 days ( 95 % CI : 7.4-13 .8 ) vs. 12.0 ( 95 % CI : 10.2-13 .8 ) ; p = 0.007 ] .
RESULTS	Pressurised irrigation group has significantly more patients experiencing lower grade of pain during wound cleansing ( 93.4 % vs. 84.2 % ; p = 0.02 ) , and significantly higher median satisfaction with either comfort or cleansing method ( MD 1 [ 95 % CI : 5-6 ] ; p = 0.002 ; MD 1 [ 95 % CI : 5-6 ] ; p < 0.001 ) than did swabbing group .
RESULTS	Wound infection was reported in 4 ( 3.3 % ) patients in pressurised irrigation group and in 7 ( 5.2 % ) patients in swabbing group ( p = 0.44 ) .
RESULTS	Cost-effectiveness analysis indicated that pressurised irrigation in comparison with swabbing saved per patient HK$ 110 ( 95 % CI : -33 to 308 ) and was a cost-effective cleansing method at no extra direct medical cost with a probability of 90 % .
CONCLUSIONS	This is the first randomised controlled trial to compare the pressurised irrigation and swabbing .
CONCLUSIONS	Pressurised irrigation is more cost-effective than swabbing in shortening time that wound heals by secondary intention with better patient tolerance .
CONCLUSIONS	Use of pressurised irrigation for wound cleansing is supported by this trial .

###25265769
BACKGROUND	Some investigators found a greater incidence of hypotension in patients receiving intrathecal hyperbaric solution than in patients receiving plain solution for cesarean section .
OBJECTIVE	Compare the effects of intrathecal hyperbaric bupivacaine 10 mg with intrathecal bupivacaine 11 mg and intrathecal levobupivacaine 11 mg , all with 10 microg of fentanyl , for cesarean section .
METHODS	This prospective , randomized , double-blinded study was approved by the Ethics Committee .
METHODS	Ninety ASA I-II parturients undergoing elective cesarean section were enrolled .
METHODS	Group H received 10 mg of 0.5 % hyperbaric bupivacaine plus fentanyl 10 g , Group B received 11 mg of 0.5 % bupivacaine plus fentanyl 10 g , and Group L received 11 mg of 0.5 % levobupivacaine plus fentanyl 10 g. Spinal anesthesia ( SA ) was undertaken in right lateral position and spinal solutions were injected approximately 30 to 40 seconds .
METHODS	Sensory and motor block were assessed at 5-minute intervals .
METHODS	Side-effects such as hypotension , nausea , pruritus , shivering , and headache were recorded
RESULTS	Demographic data were similar in all groups .
RESULTS	The level of an absence of cold sensation , the level of pinprick analgesia , and time to achieve sensory block to T4 level of Group H was significantly higher than Group B and Group L.
RESULTS	The degree of motor block was comparable in all groups .
RESULTS	The incidence of visceral pain was minimal , rated as mild pain and only found in Group B.
RESULTS	The incidence of hypotension was comparable with Group H = 67 % , Group B = 56 % , and Group L = 50 % .
RESULTS	Other side effects such as nausea , vomiting , pruritus , shivering , and headache were not statistically significant .
RESULTS	Patient 's satisfaction rated as very good and was not different between the three groups .
CONCLUSIONS	The level of absence of cold sensation , level of pinprick analgesia , and time to achieve sensory block to T4 level were statistically higher in patients receiving hyperbaric bupivacaine than in patients receiving plain bupivacaine and plain levobupivacaine , while the differences were not statistically significant in all groups regarding effective surgical anesthesia , postoperative analgesia , and side effects .
CONCLUSIONS	Therefore , Levobupivacaine can be an alternative to bupivacaine .

###25439165
OBJECTIVE	To investigate the effects of whole body vibration ( WBV ) training on gait function in persons with mild multiple sclerosis ( MS ) .
METHODS	A randomized controlled trial .
METHODS	18 patients with MS were assigned randomly to WBV ( intervention group ) or to placebo WBV .
METHODS	Both groups performed a 3-week training period under static conditions on a vibration platform .
METHODS	In the placebo group , the vibration platform was covered and therefore vibrations could not operate .
METHODS	Gait function ( gait velocity , stride length , double support phase , single-step variability left and right ) was assessed at baseline , after 3-weeks of WBV intervention or sham WBV , 4-weeks after baseline , and 5-weeks after baseline using a mobile plantar food pressure system and the `` Timed Up and Go '' test under four different gait conditions ( comfortable overground gait , comfortable gait on treadmill , -20 % comfortable gait velocity on treadmill and +20 % comfortable gait velocity on treadmill ) .
RESULTS	None of the outcome measures of gait function showed statistically significant alterations following 3-weeks of intervention/placebo WBV .
CONCLUSIONS	The applied protocol of WBV does not show a meaningful improvement of gait function in mildly affected MS patients .

###25155048
OBJECTIVE	Computer-assisted surgery ( CAS ) may facilitate better positioning of total knee arthroplasty ( TKA ) along the coronal and lateral axes ; however , there are doubts as to its usefulness in the rotational plane .
METHODS	This is a prospective study of 95 TKAs comparing two groups : the CAS group and the standard equipment group .
METHODS	The series comprises 95 cases .
METHODS	A radiography of the lower limb and computer tomographies ( CTs ) of the femoral condylar region , the proximal end of the tibia and the ankle were performed to measure rotational angulation .
METHODS	A month after TKA surgery , the radiography and the CTs were repeated to analyze the position of the prosthetic components in the rotational plane .
RESULTS	In the coronal axis , both CAS and mechanical technique improved femoro-tibial alignment , but when there are preexisting deformities 4 , CAS obtains better results .
RESULTS	A strong correlation ( R = 0.94 , p = 0.001 ) was observed between the mean rotational axis measured with CT in the tibial plateau and that measured from the axis of the ankle .
RESULTS	The mean initial femoral rotation of the complete series was 6.7 and 2.7 at 1-month follow-up ( p < 0.001 ) .
RESULTS	In the standard instrumentation group , the femoral rotation went from 6.8 to 2.3 , whereas in the CAS group the femoral rotation went from 6.5 to 3.1 ( p = 0.039 ) , which is very close to the ideal 3 angle of external rotation .
RESULTS	Tibial rotation changed by 5.28 for the entire patient population , but no differences were found when comparing CAS and standard instrumentation .
CONCLUSIONS	CAS improves frontal alignment in TKA , especially in the presence of preoperative deformities .
CONCLUSIONS	In the femoral component , navigation most closely replicated the ideal 3 external rotation of the femoral component , but tibial rotation did not differ when comparing CAS to standard instrumentation .
METHODS	II .

###24840325
BACKGROUND	Although minocycline is not licensed for use in dogs , this tetracycline has therapeutic potential against meticillin-resistant Staphylococcus pseudintermedius .
OBJECTIVE	The aim of this study was to establish rational dosage recommendations for minocycline use in dogs .
OBJECTIVE	Specific objectives were to generate and analyse minocycline pharmacokinetic ( PK ) data on plasma and interstitial fluid ( ISF ) concentrations , plasma protein binding and pharmacodynamic ( PD ) data on antimicrobial activity against S.pseudintermedius .
METHODS	Six healthy dogs from a research colony were used in this study .
METHODS	Dogs were administered 5mg/kg intravenously and 10mg/kg orally ( p.o. ) of minocycline hydrochloride in separate crossover experiments .
METHODS	In vivo drug concentrations in plasma and in ISF collected by ultrafiltration were measured by high-performance liquid chromatography .
METHODS	Pharmacokinetic analysis was performed on plasma and ISF concentrations .
METHODS	PK/PD analysis was completed using in vitro data on plasma protein binding and minocycline susceptibility in 168 S.pseudintermedius isolates .
RESULTS	Minocycline distributed to the ISF to a higher degree than predicted by the protein-unbound fraction in plasma .
RESULTS	A large volume of distribution after oral administration , with plasma and ISF elimination half-lives of 4.1 and 7.4 h , respectively , demonstrated that the ISF serves as a drug reservoir for sustained tissue concentrations .
RESULTS	Monte Carlo simulation , used to assess target attainment at different drug dosages , indicated that p.o. administration of 5mg/kg twice daily is sufficient to inhibit S.pseudintermedius strains with minimal inhibitory concentrations 0.25 g/mL .
CONCLUSIONS	Besides dosage recommendations for therapy of meticillin-resistant Staphylococcus pseudintermedius infections in dogs , the study also provides PK/PD data necessary to consider species-specific clinical breakpoints for minocycline susceptibility testing .

###24733445
BACKGROUND	Turning gait is an integral part of daily ambulation and likely poses a greater challenge for patients with transtibial amputation compared with walking a straight pathway .
BACKGROUND	A torsion adapter is a prosthetic component that can increase transverse plane compliance of the prosthesis and decrease the torque applied to the residual limb , but whether this will improve patients ' mobility , pain , and fatigue remains unknown .
OBJECTIVE	Does prescription of a torsion adapter translate to improvements in ( 1 ) functional mobility and ( 2 ) self-perceived pain and fatigue in moderately active patients with lower limb amputation ?
METHODS	Ten unilateral transtibial amputees wore a torsion or rigid adapter in random order .
METHODS	Functional mobility was assessed through a field measurement using an activity monitor and through a laboratory measurement using a 6-minute walk test that included turns .
METHODS	The residual limb pain grade assessed self-perceived pain and the Multidimensional Fatigue Inventory assessed fatigue .
RESULTS	We found relatively small functional differences for amputees wearing a torsion adapter versus a rigid adapter .
RESULTS	Amputees wearing a torsion adapter tended to take more low - and medium-intensity steps per day ( 331 365 and 437 511 difference in steps ; effect size = 0.44 and 0.17 ; confidence interval [ CI ] , 70-592 and 71-802 ; p = 0.019 and 0.024 , respectively ) .
RESULTS	They also experienced less pain interference with activities ( 1.9 1.7 change in score ; effect size = 0.83 ; CI , 0.3-3 .4 ; p = 0.026 ) when wearing a torsion adapter .
RESULTS	However , these patients took a similar number of total steps per day , walked a comparable distance in 6 minutes , and reported similar residual limb pain and fatigue .
CONCLUSIONS	For a moderately active group of amputees , the torsion adapter did not translate to substantial improvements in functional mobility and self-perceived pain and fatigue .
CONCLUSIONS	The small increases in low - and medium-intensity activities with less pain interference when wearing a torsion adapter provides evidence to support prescribing this device for amputees with difficulty navigating the household and community environments .

###25651494
OBJECTIVE	This study was designed to investigate the effect of a single-drop instillation of different lacrimal substitutes on tear film thickness ( TFT ) assessed with optical coherence tomography in patients with mild to moderate dry eye disease .
METHODS	The study was performed in a randomized , double-masked , controlled parallel group design .
METHODS	Patients received a single dose of either unpreserved trehalose 30 mg/mL and sodium hyaluronate 1.5 mg/mL ( TH-SH , Thealoz Duo ) , unpreserved sodium hyaluronate , 0.15 % ( HA , Hyabak ) or sodium chloride , 0.9 % ( NaCl , Hydrabak ) eye drops .
METHODS	Sixty patients finished the study according to the protocol .
METHODS	TFT was measured with a custom-built ultrahigh-resolution Fourier domain optical coherence tomography system providing a resolution of 1.2 m.
RESULTS	The mean TFT before treatment was 2.5 0.4 m. Ten minutes after instillation , TFT significantly increased in the TH-SH group from 2.4 0.4 to 3.1 0.9 m ( P < 0.01 ) and in the HA group from 2.4 0.3 to 2.9 0.5 m ( P < 0.01 ) , whereas no significant change was observed in the NaCl group ( from 2.6 0.4 to 2.7 0.4 m , P = 0.76 ) .
RESULTS	The increase in TFT remained statistically significant up to 240 minutes after administration of TH-SH .
RESULTS	In contrast , the increase in TFT after administration of HA was only statistically significant at 10 , 20 , and 40 minutes after drop instillation .
CONCLUSIONS	The findings of this study indicate that single instillation of TH-SH and HA eye drops increases TFT in patients with dry eye disease .
CONCLUSIONS	The data also indicate longer corneal residence of the TH-containing eye drops .
CONCLUSIONS	The effect of multiple instillation and long-term use of artificial tears on TFT warrants further investigation .

###25678687
OBJECTIVE	To evaluate the effect of intense pulsed light ( IPL ) applied to the periocular area for meibomian gland dysfunction ( MGD ) in a prospective , double-masked , placebo-controlled , paired-eye study .
METHODS	Twenty-eight participants underwent IPL treatment , with homogeneously sequenced light pulses delivered to one eye and placebo treatment to the partner control eye at 1 , 15 , and 45 days following baseline ( BL ) evaluation .
METHODS	Lipid layer grade ( LLG ) , noninvasive tear break-up time ( NIBUT ) , tear evaporation rate ( TER ) , tear meniscus height ( TMH ) , and subjective symptom score using visual analogue scales ( VAS ) were compared with BL and control values at each visit .
RESULTS	Lipid layer grade improved significantly from BL to Day ( D ) 45 in the treated eye ( P < 0.001 ) , but not the control eye ( P = 0.714 ) , with 82 % of treated eyes improving by at least one LLG .
RESULTS	Noninvasive tear break-up time also improved significantly from BL to D45 in the treated ( P < 0.001 ) but not in the control eye ( P = 0.056 ) and was significantly longer than in the treated eye at D45 ( 14.1 9.8 seconds versus 8.6 8.2 seconds , P < 0.001 ) .
RESULTS	The tear evaporation rate was not different in the treated eye compared with the control eye at any visit .
RESULTS	Tear meniscus height did not change from BL in either eye ( P > 0.05 ) .
RESULTS	Visual analog scale symptom scores improved from BL in the treated ( P = 0.015 ) , but not the control eye ( P = 0.245 ) , with 86 % of participants noting reduced symptoms in the treated eye by D45 .
CONCLUSIONS	Intense pulsed light with multiple sculpted pulses shows therapeutic potential for MGD , improving tear film quality and reducing symptoms of dry eye .
CONCLUSIONS	( https://www.anzctr.org.au number , ACTRN12614000162617 . )

###25740805
OBJECTIVE	To compare the efficacy of topical 1 % voriconazole vs 5 % natamycin for the treatment of fungal keratitis .
METHODS	In a prospective , double-masked , randomised , controlled , registered clinical trial , 118 patients with fungal keratitis were treated using identical dosage schedule with either voriconazole ( 58 ) or natamycin ( 60 ) as inpatients for 7days and followed up weekly .
METHODS	The outcome measures were percentage of patients with healed or resolving ulcer and final visual acuity at last follow-up ( primary ) and on day 7 ( secondary ) in each group .
RESULTS	More patients ( p = 0.005 ) on natamycin ( 50/56 , 89.2 % ) had healed or resolving ulcer compared with voriconazole ( 34/51 , 66.6 % ) at last follow-up .
RESULTS	The improvement in vision was marginally greater in patients in the natamycin group compared with the voriconazole group at day 7 ( p = 0.04 ) and significantly greater at final visit ( p = 0.01 ) .
RESULTS	In univariate analysis , drug , age and mean size of corneal infiltrate and epithelial defect had a significant effect on the final visual outcome .
RESULTS	In multivariate analysis , the effect of drug ( voriconazole vs natamycin , adjusted coefficient 0.27 ( -0.04 to 0.57 ) , p = 0.09 ) was marginal while the effect of age and epithelial defect was significant ( p < 0.001 for both ) .
RESULTS	In the group treated with natamycin , the final visual acuity was significantly better ( p = 0.005 , Wilcoxon signed-rank test ) in patients with Fusarium keratitis but not with Aspergillus keratitis ( p = 0.714 , paired t test ) .
CONCLUSIONS	When compared with voriconazole , natamycin was more effective in the treatment of fungal keratitis , especially Fusarium keratitis .
BACKGROUND	Clinical Trial Registry India ( 2010/091/003041 ) .

###25605856
OBJECTIVE	The Radiation Therapy Oncology Group 9804 study identified good-risk patients with ductal carcinoma in situ ( DCIS ) , a breast cancer diagnosis found frequently in mammographically detected cancers , to test the benefit of radiotherapy ( RT ) after breast-conserving surgery compared with observation .
METHODS	This prospective randomized trial ( 1998 to 2006 ) in women with mammographically detected low - or intermediate-grade DCIS , measuring less than 2.5 cm with margins 3 mm , compared RT with observation after surgery .
METHODS	The study was designed for 1,790 patients but was closed early because of lower than projected accrual .
METHODS	Six hundred thirty-six patients from the United States and Canada were entered ; tamoxifen use ( 62 % ) was optional .
METHODS	Ipsilateral local failure ( LF ) was the primary end point ; LF and contralateral failure were estimated using cumulative incidence , and overall and disease-free survival were estimated using the Kaplan-Meier method .
RESULTS	Median follow-up time was 7.17 years ( range , 0.01 to 11.33 years ) .
RESULTS	Two LFs occurred in the RT arm , and 19 occurred in the observation arm .
RESULTS	At 7 years , the LF rate was 0.9 % ( 95 % CI , 0.0 % to 2.2 % ) in the RT arm versus 6.7 % ( 95 % CI , 3.2 % to 9.6 % ) in the observation arm ( hazard ratio , 0.11 ; 95 % CI , 0.03 to 0.47 ; P < .001 ) .
RESULTS	Grade 1 to 2 acute toxicities occurred in 30 % and 76 % of patients in the observation and RT arms , respectively ; grade 3 or 4 toxicities occurred in 4.0 % and 4.2 % of patients , respectively .
RESULTS	Late RT toxicity was grade 1 in 30 % , grade 2 in 4.6 % , and grade 3 in 0.7 % of patients .
CONCLUSIONS	In this good-risk subset of patients with DCIS , with a median follow-up of 7 years , the LF rate was low with observation but was decreased significantly with the addition of RT. .
CONCLUSIONS	Longer follow-up is planned because the timeline for LF in this setting seems protracted .

###24809437
OBJECTIVE	To evaluate the effects of 2 low-calorie diets but with different distributions of calories throughout the day on weight loss and other major obesity-related metabolic parameters .
METHODS	We randomly assigned 42 nonsmoking homemakers ( age = 46.3 2.3 years , body mass index [ BMI ] = 35.7 0.8 kg/m ( 2 ) , mean SD ) in 2 groups of 21 subjects ( G1 and G2 ) .
METHODS	The participants underwent a 3 month individualized Mediterranean-style diet ( 55 % carbohydrate , 30 % fat , 15 % protein and fiber > 30 g ) , calorie ( 600 kcal daily deficit compared to the total energy expenditure measured by a metabolic Holter ) .
METHODS	Diets consisted of the same food and complied with cardiovascular disease prevention guidelines but differed in the distribution of calories throughout the day ( G1 : 70 % breakfast , morning snack , lunch and 30 % afternoon snack and dinner ; G2 : 55 breakfast , morning snack , lunch and 45 % afternoon snack and dinner ) .
METHODS	Dual-energy X-ray absorptiometry was used for pre - and postintervention body composition assessment .
RESULTS	Thirty-six subjects completed the study ( G1 = 18 , G2 = 18 ) .
RESULTS	Both groups had significant improvements in body composition and metabolic parameters but G1 had enhanced results for weight loss ( G1 : -8.2 3.0 kg ; G2 : -6.5 3.4 kg ; p = 0.028 ) , waist circumference reduction ( G1 : -7 0.6 cm ; G2 : -5 0.3 cm ; p = 0.033 ) , and fat mass loss ( G1 : -6.8 2.1 kg , G2 : -4.5 2.9 kg , p = 0.031 ; mean SD ) .
RESULTS	Improvements were detected in both groups for blood pressure and blood and lipid parameters .
RESULTS	G1 subjects showed a greater improvement in insulin sensitivity measured by homeostasis model assessment-estimated insulin resistance ( G1 : -1.37 0.27 , G2 : -0.74 0.12 , p = 0.017 ) .
CONCLUSIONS	These data suggest that a low-calorie Mediterranean diet with a higher amount of calories in the first part of the day could establish a greater reduction in fat mass and improved insulin sensitivity than a typical daily diet .

###24498092
OBJECTIVE	Dynamic contrast-enhanced magnetic resonance imaging ( DCE-MRI ) is increasingly used for breast cancer diagnosis as supplementary to conventional imaging techniques .
OBJECTIVE	Combining of diffusion-weighted imaging ( DWI ) of morphology and kinetic features from DCE-MRI to improve the discrimination power of malignant from benign breast masses is rarely reported .
METHODS	The study comprised of 234 female patients with 85 benign and 149 malignant lesions .
METHODS	Four distinct groups of features , coupling with pathological tests , were estimated to comprehensively characterize the pictorial properties of each lesion , which was obtained by a semi-automated segmentation method .
METHODS	Classical machine learning scheme including feature subset selection and various classification schemes were employed to build prognostic model , which served as a foundation for evaluating the combined effects of the multi-sided features for predicting of the types of lesions .
METHODS	Various measurements including cross validation and receiver operating characteristics were used to quantify the diagnostic performances of each feature as well as their combination .
RESULTS	Seven features were all found to be statistically different between the malignant and the benign groups and their combination has achieved the highest classification accuracy .
RESULTS	The seven features include one pathological variable of age , one morphological variable of slope , three texture features of entropy , inverse difference and information correlation , one kinetic feature of SER and one DWI feature of apparent diffusion coefficient ( ADC ) .
RESULTS	Together with the selected diagnostic features , various classical classification schemes were used to test their discrimination power through cross validation scheme .
RESULTS	The averaged measurements of sensitivity , specificity , AUC and accuracy are 0.85 , 0.89 , 90.9 % and 0.93 , respectively .
CONCLUSIONS	Multi-sided variables which characterize the morphological , kinetic , pathological properties and DWI measurement of ADC can dramatically improve the discriminatory power of breast lesions .

###25948287
BACKGROUND	Depression is one of the most common disorders in Psychiatric and Primary Care settings and is associated with significant disability and economic costs .
BACKGROUND	Low-intensity psychological interventions applied by Information and Communication Technologies ( ICTs ) could be an efficacious and cost-effective therapeutic option for the treatment of depression .
BACKGROUND	The aim of this study is to assess 3 low-intensity psychological interventions applied by ICTs ( healthy lifestyle , positive affect and mindfulness ) in Primary Care ; significant efficacy for depression treatment has previously showed in specialized clinical settings by those interventions , but ICTs were not used .
METHODS	Multicenter controlled randomized clinical trial in 4 parallel groups .
METHODS	Interventions have been designed and on-line device adaptation has been carried out .
METHODS	Subsequently , the randomized controlled clinical trial will be conducted .
METHODS	A sample of N = 240 mild and moderate depressed patients will be recruited and assessed in Primary Care settings .
METHODS	Patients will be randomly assigned to a ) healthy lifestyle psychoeducational program + improved primary care usual treatment ( ITAU ) , b ) focused program on positive affect promotion + ITAU c ) mindfulness + ITAU or d ) ITAU .
METHODS	The intervention format will be one face to face session and four ICTs on-line modules .
METHODS	Patients will be diagnosed with MINI psychiatric interview .
METHODS	Main outcome will be PHQ-9 score .
METHODS	They will be also assessed by SF-12 Health Survey , Client Service Receipt Inventory , EuroQoL-5D questionnaire , Positive and Negative Affect Scale , Five Facet Mindfulness Questionnaire and the Pemberton Happiness Index .
METHODS	Patients will be assessed at baseline , post , 6 and 12 post-treatment months .
METHODS	An intention to treat and per protocol analysis will be performed .
CONCLUSIONS	Low-intensity psychological interventions applied by Information and Communication Technologies have been not used before in Spain and could be an efficacious and cost-effective therapeutic option for depression treatment .
CONCLUSIONS	The strength of the study is that it is the first multicenter controlled randomized clinical trial of three low intensity and self-guided interventions applied by ICTs ( healthy lifestyle psychoeducational program ; focused program on positive affect promotion and brief intervention based on mindfulness ) in Primary Care settings .
BACKGROUND	Current Controlled Trials ISRCTN82388279 .
BACKGROUND	Registered 16 April 2014 .

###25208853
BACKGROUND	In Lebanon , childhood obesity doubled during the past decade .
BACKGROUND	Preventive measures should start early in life and Schools are considered an important environment to promote energy balance health behaviours .
BACKGROUND	School-based programmes promoting healthy lifestyles are lacking .
BACKGROUND	The purpose of this study was to evaluate the feasibility and effectiveness of a multicomponent school-based intervention to promote healthy eating and physical activity ( and prevent obesity ) with school children aged 9-11 years in Lebanon .
METHODS	The intervention was developed based on the constructs of the Social Cognitive Theory and adapted to the culture of Lebanese and Arab populations .
METHODS	It consisted of three components : class curriculum , family involvement and food service .
METHODS	Eight schools were purposively selected from two communities of different socioeconomic status ( SES ) in Beirut and , within each school type , were matched on SES , religious sect profile , and then randomly assigned to either the intervention or control group .
METHODS	Anthropometric measurements and questionnaires on determinants of behavioural change , eating and physical activity habits were completed by the students in both groups at baseline and post intervention .
METHODS	Focus group interviews were conducted in intervention schools at the end of the study .
METHODS	Challenges encountered during the programme implementation were also identified , since Lebanon is considered a country with political unrest and no similar research projects were conducted in the area .
RESULTS	Students in the intervention group reported purchasing and consuming less chips and sweetened drinks post-intervention compared with controls ( 86 % & 88 % less respectively p < 0.001 ) .
RESULTS	Knowledge and self-efficacy scores increased for the intervention ( +2.8 & +1.7 points respectively p < 0.001 ) but not for the control group .
RESULTS	There was no difference in physical activity and screen time habits and no changes in BMI between groups at post intervention .
RESULTS	Interview data from focus groups showed that the programme was generally well accepted .
RESULTS	Limitations for better outcomes include the length of the programme and the school environment .
CONCLUSIONS	`` Health-E-PALS '' intervention is a promising innovative , theory-based , culturally sensitive intervention to promote healthy eating habits and physical activity in Lebanese school children with a potential to be scaled up , replicated and sustained .

###24313385
BACKGROUND	Melasma is an acquired hyperpigmentation on sun-exposed areas .
BACKGROUND	Multiple approaches are used to treat it , but all include broad ultraviolet ( UV ) - spectrum sunscreens .
BACKGROUND	Visible light ( VL ) can induce pigmentary changes similar to those caused by UV radiation on darker-skinned patients .
OBJECTIVE	To assess the efficacy of sunscreen with broad-spectrum UV protection that contains iron oxide as a VL-absorbing pigment ( UV-VL ) compared with a regular UV-only broad-spectrum sunscreen for melasma patients exposed to intense solar conditions .
METHODS	Sixty-eight patients with melasma were randomized in two groups to receive either UV-VL sunscreen or UV-only sunscreen , both with sun protection factor 50 , over 8 weeks .
METHODS	All patients received 4 % hydroquinone as a depigmenting treatment .
METHODS	At onset and at conclusion of the study , they were assessed by the Melasma Activity and Severity Index ( MASI ; a subjective scale ) , colorimetry ( L * ) and histological analysis of melanin .
RESULTS	Sixty-one patients concluded the study .
RESULTS	At 8 weeks , the UV-VL group showed 15 % , 28 % and 4 % greater improvements than the UV-only group in MASI scores , colorimetric values and melanin assessments , respectively .
CONCLUSIONS	UV-VL sunscreen enhances the depigmenting efficacy of hydroquinone compared with UV-only sunscreen in treatment of melasma .
CONCLUSIONS	These findings suggest a role for VL in melasma pathogenesis .

###24228847
BACKGROUND	Both vitamin C deficiency and inflammation are prevalent in maintenance hemodialysis ( MHD ) patients .
BACKGROUND	In this study , we aimed to elucidate the effect of oral vitamin C supplementation on inflammatory status in MHD patients with low vitamin C level and high hypersensitive C-reactive protein ( hs-CRP ) level .
METHODS	A total of 128 patients were recruited in our present study .
METHODS	Patients were divided into two groups .
METHODS	In group 1 ( n = 67 ) , patients were orally administered with 200 mg/day vitamin C in the first 3 months , and then the vitamin C supplementation was withdrawn in the next 3 months .
METHODS	In group 2 ( n = 61 ) , patients were not given vitamin C in the first 3 months , and then they were orally administered with 200 mg/day in the next 3 months .
METHODS	Levels of hs-CRP , prealbumin , albumin and hemoglobin as well as the EPO resistance index ( ERI ) were determined at the baseline and every 3 months throughout the study .
METHODS	Plasma vitamin C level was determined by high-performance liquid chromatography with UV detection .
RESULTS	Among the 128 patients , 28 of them dropped out of the study before completion .
RESULTS	Consequently , a total of 100 patients ( group 1 : n = 48 ; group 2 : n = 52 ) were included in the final analysis .
RESULTS	At the baseline , the plasma vitamin C level of all patients was less than 4 g/mL .
RESULTS	However , this proportion was decreased to 20 % after the vitamin C supplementation for 3 months .
RESULTS	Compared with patients without the vitamin C supplementation , a decreased level of hs-CRP and an increased level of prealbumin were induced by the vitamin C supplementation for 3 months in both groups .
RESULTS	However , levels of these biomarkers returned to their original state after the supplementation was withdrawn .
RESULTS	Same beneficial effects on plasma albumin , hemoglobin and ERI response to vitamin C supplementation were observed in the two groups without statistical significance .
CONCLUSIONS	The inflammatory status in MHD patients with plasma vitamin C deficiency and high levels of inflammatory markers could be partially improved by long-term oral administration of small doses of vitamin C.
BACKGROUND	The clinical trial number : NCT01356433 .

###25283504
OBJECTIVE	Pharmacodynamic analysis of intravenous recombinant urate oxidase produced by Escherichia coli was performed in healthy subjects using a pharmacokinetic/pharmacodynamic ( PK/PD ) model .
METHODS	A randomized , single-blind , placebo-controlled study was performed in 40 healthy Chinese subjects ( 4 groups of 10 subjects each , placebo 4:1 ratio ) who received infusions of uricase ( single doses of 0.1 , 0.2 , and 0.3 mg/kg ; multiple doses of 0.2 mgkg ( -1 ) d ( -1 ) for 7 d ) .
METHODS	PK profiles were determined through plasma uricase activity , and PD profiles were established using uric acid levels in plasma and urine .
METHODS	The plasma PD parameter was estimated as changes in plasma uric acid levels as the effect in the indirect response model .
METHODS	Adverse events were also monitored .
RESULTS	A two-compartment PK model with constant iv input and first-order output was used to describe the kinetic process of plasma uricase .
RESULTS	The low value ( 2.8 U/L ) of drug concentration that achieved 50 % of maximum effect ( EC50 ) indicated that low plasma uricase concentrations were sufficient to produce pharmacological effects .
RESULTS	A strong relationship ( r ( 2 ) = 0.9991 ) between the mean uric acid concentration in blood and the mean uric acid excretion rate in urine in the range of 11 to 30 h after single dosing was found .
RESULTS	Infusions of uricase were well tolerated in all subjects .
CONCLUSIONS	The PK/PD model predicted the effective dose to be 0.1 mg/kg in healthy subjects .
CONCLUSIONS	The excretion rate of uric acid in urine may be used as a new index for pharmacological effects in further clinical trials .

###24558835
OBJECTIVE	To study the effect of Bushen Huoxue Herbs on depression of patients with Parkinson 's disease .
METHODS	Ninety-six patients were randomized into two groups with 46 patients in the treatment group and 50 patients in the control group .
METHODS	Both groups took western medicine as basic treatment .
METHODS	The treatment group was treated with Bushen Huoxue Herbs additionally .
METHODS	The observation was carried out for 9 months .
METHODS	Used Encephalofluctuograph Technology ( ET ) and Hamilton Depression Scale ( HAMD ) to measure the changes of cerebral neurotransmitters and scale scores in both groups at baseline time , 3 , 6 and 9 months later to evaluate the effects of Bushen Huoxue Herbs .
RESULTS	In the treatment group , 5-hydroxytryptamine ( 5-HT ) , noradrenaline ( NE ) and dopamine ( DA ) levels were increased significantly when compared with pretreatment ( P < 0.05 ) , especially of 5-HT and DA levels ( P < 0.01 ) ; Compared with the control group , 5-HT and DA levels were increased significantly ( P < 0.05 ) .
RESULTS	After treatment , the scores of the HAMD scale was significantly decreased ( P < 0.05 ) .
RESULTS	No adverse effects were found in this trial .
CONCLUSIONS	Bushen Huoxue Herbs can improve depression of PD patients by increasing the levels of 5-HT , NE and DA in the brain and decreasing the scores of the HAMD scale with reliable effects .

###24951020
OBJECTIVE	Acute acquired hypofibrinogenemia in children undergoing cardiac surgery is a major concern because it often results in perioperative bleeding and high rates of allogeneic blood transfusion .
OBJECTIVE	Fibrinogen concentrate has been proposed as an alternative to cryoprecipitate ( the gold standard therapy ) , with minimal infectious and immunologic risks .
OBJECTIVE	Our objective was to investigate the efficacy and safety of fibrinogen concentrate in children undergoing cardiac surgery .
METHODS	In this randomized pilot study , patients were allocated to receive fibrinogen concentrate ( 60 mg/kg ) or cryoprecipitate ( 10 mL/kg ) if bleeding was associated with fibrinogen levels < 1 g/dL after cardiopulmonary bypass weaning .
METHODS	The primary outcome was postoperative blood losses during the 48 hours after surgery .
RESULTS	A total of 63 patients were included in the study , 30 in the fibrinogen concentrate group and 33 in the cryoprecipitate group .
RESULTS	The median 48-hour blood loss was not significantly different between the 2 groups ( 320 mL [ interquartile range , 157-750 ] vs 410 mL [ interquartile range , 215-510 ] , respectively ; P = .672 ) .
RESULTS	After treatment , plasma fibrinogen concentration increased similarly following administration of both products .
RESULTS	There were no differences in allogeneic blood transfusion after intervention treatment .
CONCLUSIONS	A large trial comparing fibrinogen concentrate and cryoprecipitate in the management of children with acute acquired hypofibrinogenemia during heart surgery is feasible .
CONCLUSIONS	The preliminary results of our study showed that the use of fibrinogen concentrate was as efficient and safe as cryoprecipitate in the management of bleeding children undergoing cardiac surgery .

###24252173
OBJECTIVE	Sleep problems are common and persistent during adolescence and can have negative effects on adolescents ' mood .
OBJECTIVE	To date , studies that investigate the effects of sleep extension on adolescents ' sleep and depressive symptoms are still lacking .
OBJECTIVE	This study aims to investigate the effects of gradual sleep extension combined with sleep hygiene advice in adolescents with chronic sleep reduction on objectively measured sleep , self-reported sleep problems and depressive symptoms .
METHODS	Fifty-five adolescents with chronic sleep reduction ( mean age : 15.44 years ; 85.5 % females ) were included in the study .
METHODS	Participants were randomly assigned to either a sleep extension group ( gradual sleep extension by advancing bedtimes in the evening and receiving sleep hygiene advice ) or to a control group ( no instruction ) .
METHODS	Sleep was measured with actigraphy during threeweeks , the first week was the baseline week , and the last twoweeks were the experimental weeks during which sleep was extended .
METHODS	Other outcome variables were self-reported sleep problems ( daytime sleepiness , symptoms of insomnia and circadian rhythm sleep disorder ) and depressive symptoms , which were assessed before and after the experimental manipulation .
RESULTS	During the third week of the experiment , adolescents in the sleep extension group had earlier bedtimes , earlier sleep onsets , spent more time in bed and slept longer than adolescents in the control group .
RESULTS	Their chronic sleep reduction , insomnia symptoms and depressive symptoms diminished significantly .
RESULTS	In addition , there was a trend of improved circadian rhythm sleep disorder symptoms and sleep quality .
CONCLUSIONS	Gradual sleep extension combined with sleep hygiene advice seems to have beneficial effects on sleep , self-reported sleep problems and depressive symptoms of adolescents with chronic sleep reduction .
CONCLUSIONS	Although we can not distinguish between the effects of sleep extension and sleep hygiene advice , the results suggest that advancing bedtimes can extend sleep and improve depressive symptoms .

###24398115
BACKGROUND	Bruxism is a parafunctional habit characterized by grinding and/or clenching of the teeth .
BACKGROUND	It may happen while awake ( awake bruxism ) or while sleeping ( sleep bruxism ) .
BACKGROUND	In adults , the prevalence is 20 % for the awake bruxism and 8 % for the sleep bruxism .
BACKGROUND	Peripheral , central , and psychosocial factors influence the disorder , which may predispose to pain in the masticatory muscles and neck , headache , decreased pain thresholds in the masticatory and cervical muscles , limitation mandibular range of motion , sleep disorders , stress , anxiety , depression , and overall impairment of oral health .
BACKGROUND	The aim of this study is to compare two distinct physical therapy interventions with dental treatment in pain , mandibular range of motion , sleep quality , anxiety , stress , depression , and oral health in individuals with bruxism .
METHODS	Participants will be randomized into one of three groups : Group 1 ( n = 24 ) intervention will consist of massage and stretching exercises ; Group 2 ( n = 24 ) will consist of relaxation and imagination therapies ; and Group 3 ( n = 24 ) will receive dental treatment .
METHODS	The evaluations will be performed at baseline , immediately after treatment , and at 2-month follow-up .
METHODS	Pain intensity will be assessed using the visual analogical scale , while pain thresholds will be determined using dolorimetry .
METHODS	Mandibular range of motion will be assessed using digital pachymeter .
METHODS	Sleep quality will be assessed by the Pittsburgh Sleep Quality Index , anxiety by the State-Trait Anxiety Inventory , stress by the Perceived Stress Scale-10 , depression by the Beck Depression Inventory , and oral health will be assessed using the Oral Health Impact Profile -- 14 .
METHODS	Significance level will be determined at the 5 % level .
CONCLUSIONS	This project describes the randomization method that will be used to compare two physical therapy interventions with dental treatment in the management of pain , mandibular range of motion , sleep quality , anxiety , stress , depression , and oral health in individuals with bruxism .
CONCLUSIONS	The study will support the practice of evidence-based physical therapy for individuals with bruxism .
CONCLUSIONS	Data will be published after study is completed .
BACKGROUND	ClinicalTrials.gov , NCT01778881 .

###24931322
BACKGROUND	Vatreptacog alfa , a recombinant factor VIIa ( rFVIIa ) analog with three amino acid substitutions and 99 % identity to native FVIIa , was developed to improve the treatment of hemophilic patients with inhibitors .
OBJECTIVE	To confirm the safety and assess the efficacy of vatreptacog alfa in treating bleeding episodes in hemophilic patients with inhibitors .
METHODS	In this international , multicenter , randomized , double-blind , active-controlled , crossover , confirmatory phase III trial ( adept ( ) 2 ) in patients with hemophilia A or B and inhibitors , bleeds were randomized 3 : 2 to treatment with vatreptacog alfa ( one to three doses at 80 g kg ( -1 ) ) or rFVIIa ( one to three doses at 90 g kg ( -1 ) ) .
METHODS	Treatment failures after three doses of trial product ( TP ) were managed according to the local standard of care .
RESULTS	In the 72 patients enrolled , 567 bleeds were treated with TP .
RESULTS	Both vatreptacog alfa and rFVIIa gave 93 % effective bleeding control at 12 h. Vatreptacog alfa was superior to rFVIIa in secondary efficacy outcomes , including the number of doses used to treat a bleed and sustained bleeding control 24-48 h after the first dose .
RESULTS	Eight patients ( 11 % ) developed antibodies against vatreptacog alfa , including four with cross-reactivity against rFVIIa and one with an in vitro neutralizing effect to vatreptacog alfa .
CONCLUSIONS	This large randomized controlled trial confirmed the well-established efficacy and safety profile of rFVIIa , and showed that vatreptacog alfa had similar or better efficacy than rFVIIa .
CONCLUSIONS	However , because of the development of anti-drug antibodies , a positive benefit-risk profile is unlikely to be achieved with vatreptacog alfa .

###25581251
BACKGROUND	Prucalopride is a high-affinity 5-HT4 receptor agonist for the treatment of chronic constipation .
BACKGROUND	The aims of this study were to investigate the relationship between health-related quality of life ( HRQoL ) and symptoms of constipation , and to assess the response of HRQoL to treatment using integrated data from three phase III trials of prucalopride .
METHODS	This was an integrated analysis of data from three pivotal multicenter , double-blind , randomized , placebo-controlled , parallel-group trials ( ClinicalTrials.gov Identifiers : NCT00488137 , NCT00483886 and NCT00485940 ) .
METHODS	Relationships were investigated between Patient Assessment of Constipation Quality of Life ( PAC-QOL ) scores , Patient Assessment of Constipation Symptoms ( PAC-SYM ) scores , bowel movement frequency ( assessed using daily diaries ) , and treatment .
RESULTS	Patients treated with prucalopride 2 mg ( n = 659 ) and placebo ( n = 661 ) were included in the analysis .
RESULTS	An improvement in PAC-SYM scores correlated well with an improvement in PAC-QOL overall score ( r = 0.711 ) and satisfaction subscale score ( r = 0.589 ) .
RESULTS	After 12 weeks , PAC-QOL overall score and satisfaction subscale score significantly ( p < 0.001 ) improved by 1 point ( clinically relevant ) in 36.5 % and 44.1 % of patients treated with prucalopride , compared with 18.5 % and 22.4 % with placebo respectively .
RESULTS	Moreover , 39.0 % of patients with an improvement in satisfaction of 1 point achieved 3 spontaneous complete bowel movements/week , compared with 7.4 % of those with no improvement in satisfaction ( < 1 point ) .
CONCLUSIONS	Improvements in PAC-QOL overall score and satisfaction score were associated with improvements in symptoms of chronic constipation .
CONCLUSIONS	Compared with placebo , treatment with prucalopride significantly improved HRQoL .

###24363128
BACKGROUND	Combined treatment with cyclosporine microemulsion preconcentrate ( CyA MEPC ) and steroids has been widely used for idiopathic membranous nephropathy ( IMN ) associated with steroid-resistant nephrotic syndrome ( SRNS ) .
BACKGROUND	Recent studies have shown that once-a-day and preprandial administration of CyA MEPC is more advantageous than the conventional twice-a-day administration in achieving the target blood CyA concentration at 2 h post dose ( C2 ) .
BACKGROUND	We designed a randomized trial to compare these administrations .
METHODS	IMN patients with SRNS ( age 16-75 years ) were divided prospectively and randomly into 2 groups .
METHODS	In group 1 ( n = 23 ) , 2-3 mg/kg body weight ( BW ) CyA MEPC was given orally once a day before breakfast .
METHODS	In group 2 ( n = 25 ) , 1.5 mg/kg BW CyA MEPC was given twice a day before meals .
METHODS	CyA + prednisolone was continued for 48 weeks .
RESULTS	Group 1 showed a significantly higher cumulative complete remission ( CR ) rate ( p = 0.0282 ) , but not when incomplete remission 1 ( ICR1 ; urine protein 0.3-1 .0 g/day ) was added ( p = 0.314 ) .
RESULTS	Because a C2 of 600 ng/mL was determined as the best cut-off point , groups 1 and 2 were further divided into subgroups A ( C2 600 ng/mL ) and B ( C2 < 600 ng/mL ) .
RESULTS	Groups 1A and 2A revealed significantly higher cumulative remission ( CR + ICR1 ) ( p = 0.0069 ) and CR-alone ( p = 0.0028 ) rates .
RESULTS	On the other hand , 3 patients with high CyA levels ( C2 > 900 ng/mL ) in Group 1A were withdrawn from the study because of complications .
CONCLUSIONS	CyA + prednisolone treatment is effective for IMN with associated SRNS at a C2 of 600 ng/mL .
CONCLUSIONS	To achieve remission , preprandial once-a-day administration of CyA at 2-3 mg/kg BW may be the most appropriate option .
CONCLUSIONS	However , we should adjust the dosage of CyA by therapeutic drug monitoring to avoid complications .

###25605628
BACKGROUND	The optimal surgical approach for treatment of oesophagogastric junction ( OGJ ) cancer is controversial .
BACKGROUND	A randomized clinical trial ( JCOG9502 ) comparing transhiatal ( TH ) and left thoracoabdominal ( LTA ) approaches was stopped after the first interim analysis owing to limited efficacy for LTA resections .
BACKGROUND	Complete 10-year follow-up data are now available .
METHODS	Patients with histologically proven adenocarcinoma of the OGJ or gastric cardia with oesophageal invasion of 3cm or less were randomized to a TH or LTA approach .
METHODS	Both groups underwent total gastrectomy and splenectomy with D2 nodal dissection plus para-aortic lymphadenectomy above the left renal vein .
METHODS	For LTA , a thorough mediastinal lymphadenectomy below the left inferior pulmonary vein was also mandatory .
METHODS	The primary endpoint was overall survival .
RESULTS	A total of 167 patients ( 82 TH , 85 LTA ) were enrolled .
RESULTS	The 10-year overall survival rate was 37 ( 95 per cent c.i. 26 to 47 ) per cent for the TH approach and 24 ( 15 to 34 ) per cent for the LTA technique ( P = 0060 ) .
RESULTS	The hazard ratio for death was 142 ( 098 to 205 ) for the LTA technique .
RESULTS	Subgroup analysis based on the Siewert classification indicated non-significant survival advantages in favour of the TH approach .
CONCLUSIONS	LTA resections should be avoided in the treatment of adenocarcinoma of the OGJ or gastric cardia .
BACKGROUND	NCT00149266 ( https://www.clinicaltrials.gov ) .

###25060372
BACKGROUND	Infections are the most common noncardiac complication after cardiac surgery , but their incidence across a broad range of operations , as well as the management factors that shape infection risk , remain unknown .
OBJECTIVE	This study sought to prospectively examine the frequency of post-operative infections and associated mortality , and modifiable management practices predictive of infections within 65 days from cardiac surgery .
METHODS	This study enrolled 5,158 patients and analyzed independently adjudicated infections using a competing risk model ( with death as the competing event ) .
RESULTS	Nearly 5 % of patients experienced major infections .
RESULTS	Baseline characteristics associated with increased infection risk included chronic lung disease ( hazard ratio [ HR ] : 1.66 ; 95 % confidence interval [ CI ] : 1.21 to 2.26 ) , heart failure ( HR : 1.47 ; 95 % CI : 1.11 to 1.95 ) , and longer surgery ( HR : 1.31 ; 95 % CI : 1.21 to 1.41 ) .
RESULTS	Practices associated with reduced infection risk included prophylaxis with second-generation cephalosporins ( HR : 0.70 ; 95 % CI : 0.52 to 0.94 ) , whereas post-operative antibiotic duration > 48 h ( HR : 1.92 ; 95 % CI : 1.28 to 2.88 ) , stress hyperglycemia ( HR : 1.32 ; 95 % CI : 1.01 to 1.73 ) ; intubation time of 24 to 48 h ( HR : 1.49 ; 95 % CI : 1.04 to 2.14 ) ; and ventilation > 48 h ( HR : 2.45 ; 95 % CI : 1.66 to 3.63 ) were associated with increased risk .
RESULTS	HRs for infection were similar with either < 24 h or < 48 h of antibiotic prophylaxis .
RESULTS	There was a significant but differential effect of transfusion by surgery type ( excluding left ventricular assist device procedures/transplant ) ( HR : 1.13 ; 95 % CI : 1.07 to 1.20 ) .
RESULTS	Major infections substantially increased mortality ( HR : 10.02 ; 95 % CI : 6.12 to 16.39 ) .
CONCLUSIONS	Major infections dramatically affect survival and readmissions .
CONCLUSIONS	Second-generation cephalosporins were strongly associated with reduced major infection risk , but optimal duration of antibiotic prophylaxis requires further study .
CONCLUSIONS	Given practice variations , considerable opportunities exist for improving outcomes and preventing readmissions .
CONCLUSIONS	( Management Practices and Risk of Infection Following Cardiac Surgery ; NCT01089712 ) .

###24786930
OBJECTIVE	To evaluate the outcome of resistive home exercise and its possible longterm influence on health , disability , and disease activity in patients with active polymyositis ( PM ) or dermatomyositis ( DM ) .
METHODS	Nineteen patients with recent-onset PM/DM were included after introduction of high-dose prednisolone .
METHODS	They were assessed by independent assessors as to perceived health , muscle performance , aerobic capacity , and serum creatine phosphokinase ( CPK ) at baseline and after 24 weeks , including repeated muscle biopsies at 24 weeks ( single-blinded randomized controlled study ) , and in an open-label followup at 52 , 78 , and 104 weeks .
METHODS	Patients were randomized to 12 weeks , 5 days/week resistive home exercise with telephone support and encouragement for another 12 weeks of twice-a-week home or gym exercise ( EG , n = 10 ) or to 24 weeks , 5 days/week range of motion exercise ( CG , n = 9 ) .
METHODS	Patients in the CG group without inflammatory infiltrates in muscle biopsies at 24 weeks were invited to the 12-week resistive home exercises .
RESULTS	At baseline , the EG had poorer perceived health , but otherwise the groups were comparable .
RESULTS	At 24 weeks , both groups improved in muscle performance and aerobic capacity ( p < 0.001 to < 0.05 ) with no signs of increased inflammation assessed by CPK levels or muscle biopsies .
RESULTS	Both groups improved in muscle performance and aerobic capacity up to 52 weeks ( p < 0.05 ) lasting to 104 weeks in the EG ( p < 0.05 ) and presented minor improvements in perceived health .
CONCLUSIONS	Our study supports the safety of resistive exercise in patients with active PM/DM but did not reveal any between-group differences in exercise effects .
CONCLUSIONS	An individually adapted physical therapist-supervised home exercise program might be recommended in early active PM/DM , with regular evaluation of muscle performance and health .

###24378206
OBJECTIVE	Dapagliflozin is a highly selective , orally active inhibitor of renal sodium-glucose cotransporter 2 that reduces hyperglycemia by increasing urinary glucose excretion .
OBJECTIVE	The goal of this study was to evaluate dapagliflozin as monotherapy in drug-naive Asian patients with type 2 diabetes whose disease was inadequately controlled with diet and exercise .
METHODS	In this Phase III , multicenter , parallel-group , double-blind study , drug-naive patients with glycosylated hemoglobin ( HbA1c ) levels 7.0 % to 10.5 % ( 53-91 mmol/mol ) were randomized ( by using an interactive voice response system ) to receive placebo ( n = 132 ) , dapagliflozin 5 mg ( n = 128 ) , or dapagliflozin 10 mg ( n = 133 ) .
METHODS	The primary end point was mean change from baseline in HbA1c level at week 24 ( last-observation-carried-forward ) .
METHODS	Secondary end points included changes in fasting plasma glucose , 2-hour postprandial glucose , body weight , and other glycemic parameters .
RESULTS	Baseline characteristics were balanced across groups .
RESULTS	Most patients ( 89 % ) were Chinese , median disease duration was 0.2 year , and mean HbA1c level was 8.26 % .
RESULTS	Most patients ( 87 % ) completed the study .
RESULTS	At week 24 , mean reductions in HbA1c were -0.29 % for placebo versus -1.04 % and -1.11 % for dapagliflozin 5 and 10 mg , respectively ( P < 0.0001 for both doses ) .
RESULTS	Changes in fasting plasma glucose were 2.5 , -25.1 , and -31.6 mg/dL ( 0.14 , -1.39 , and -1.75 mmol/L ) for placebo , dapagliflozin 5 mg , and dapagliflozin 10 mg .
RESULTS	Changes in 2-hour postprandial glucose were 1.1 , -46.8 , and -54.9 mg/dL ( 0.06 , -2.60 , and -3.05 mmol/L ) .
RESULTS	Reductions in body weight were -0.27 , -1.64 , and -2.25 kg .
RESULTS	Proportions of patients achieving HbA1c levels < 7.0 % ( 53 mmol/mol ) were 21.3 % , 42.6 % , and 49.8 % .
RESULTS	Adverse events ( AEs ) occurred in 63.6 % , 61.7 % , and 60.9 % of patients , and serious AEs occurred in 1.5 % , 3.9 % , and 3.0 % of patients .
RESULTS	No deaths occurred .
RESULTS	Hypoglycemia was uncommon ( 1.5 % , 0.8 % , and 0.8 % ) ; no hypoglycemic event led to discontinuation .
RESULTS	Genital infections occurred in 0.8 % , 3.1 % , and 4.5 % of patients and urinary tract infections in 3.0 % , 3.9 % , and 5.3 % of patients .
RESULTS	No AEs of renal infection or pyelonephritis were reported .
RESULTS	No changes in renal function or AEs of renal failure occurred .
CONCLUSIONS	Compared with placebo , dapagliflozin 5 and 10 mg demonstrated clinically and statistically significant improvements in HbA1c levels after 24 weeks of treatment .
CONCLUSIONS	Dose-dependent , statistically significant reductions in fasting plasma glucose , postprandial glucose , and weight were also observed for both doses compared with placebo .
CONCLUSIONS	AEs and serious AEs were balanced across groups , with low rates of hypoglycemia and no increase in renal events .
CONCLUSIONS	Genital infections and urinary tract infections were more common with dapagliflozin .
CONCLUSIONS	Dapagliflozin as monotherapy in these drug-naive Asian patients was well tolerated , significantly improving glycemic control with the additional benefit of weight loss .

###25365798
BACKGROUND	Correcting volumetric measurements of brain structures for intracranial volume ( ICV ) is important in comparing volumes across subjects with different ICV .
BACKGROUND	The aim of this study was to investigate whether intracranial area ( ICA ) reliably predicts actual ICV in a healthy pediatric cohort and in children with convulsive status epilepticus ( CSE ) .
METHODS	T1-weighted volumetric MRI was performed on 20 healthy children ( control group ) , 10 with CSE with structurally normal MRI ( CSE/MR - ) , and 12 with CSE with structurally abnormal MRI ( CSE/MR + ) .
METHODS	ICA , using a mid-sagittal slice , and the actual ICV were measured .
RESULTS	A high Spearman correlation was found between the ICA and ICV measurements in the control ( r = 0.96 ; P < 0.0001 ) , CSE/MR - ( r = 0.93 ; P = 0.0003 ) , and CSE/MR + ( r = 0.94 ; P < 0.0001 ) groups .
RESULTS	On comparison of predicted and actual ICV , there was no significant difference in the CSE/MR - group ( P = 0.77 ) .
RESULTS	However , the comparison between predicted and actual ICV was significantly different in the CSE/MR + ( P = 0.001 ) group .
RESULTS	Our Bland-Altman plot showed that the ICA method consistently overestimated ICV in children in the CSE/MR + group , especially in those with small ICV or widespread structural abnormalities .
CONCLUSIONS	After further validation , ICA measurement may be a reliable alternative to measuring actual ICV when correcting volume measurements for ICV , even in children with localized MRI abnormalities .
CONCLUSIONS	Caution should be applied when the method is used in children with small ICV and those with multilobar brain pathology .

###24585721
BACKGROUND	The role of zoledronic acid ( ZA ) when added to the neoadjuvant treatment of breast cancer ( BC ) in enhancing the clinical and pathological response of tumors is unclear .
BACKGROUND	The effect of ZA on the antitumor effect of neoadjuvant chemotherapy has not prospectively been studied before .
METHODS	NEOZOTAC is a national , multicenter , randomized study comparing the efficacy of TAC ( docetaxel , adriamycin and cyclophosphamide i.v. ) followed by granulocyte colony-stimulating factor on day 2 with or without ZA 4 mg i.v. q 3 weeks inpatients withstage II/III , HER2-negative BC .
METHODS	We present data on the pathological complete response ( pCR in breast and axilla ) , on clinical response using MRI , and toxicity .
METHODS	Post hoc subgroup analyses were undertaken to address the predictive value of menopausal status .
RESULTS	Addition of ZA to chemotherapy did not improve pCR rates ( 13.2 % for TAC+ZA versus 13.3 % for TAC ) .
RESULTS	Postmenopausal women ( N = 96 ) had a numerical benefit from ZA treatment ( pCR 14.0 % for TAC+ZA versus 8.7 % for TAC , P = 0.42 ) .
RESULTS	Clinical objective response did not differ between treatment arms ( 72.9 % versus 73.7 % ) .
RESULTS	There was no difference in grade III/IV toxicity between treatment arms .
CONCLUSIONS	Addition of ZA to neoadjuvant chemotherapy did not improve pathological or clinical response to chemotherapy .
CONCLUSIONS	Further investigations are warranted in postmenopausal women with BC , since this subgroup might benefit from ZA treatment .

###25138123
OBJECTIVE	To evaluate the effect of an exercise training program combining low-impact dance aerobic , resistance and stretching exercise on physical fitness , hormone and lipid levels of postpartum , primiparous , lactating women .
METHODS	Thirty seven primiparous , lactating women were randomly assigned at 4-6 weeks postpartum to either follow an exercise training program of 50-60 min aerobic , strengthening and stretching exercise , 3 days a week , for 12 weeks ( interventional group ; n = 20 ) or no training program at all ( control group ; n = 17 ) .
METHODS	The following parameters were measured at baseline and 12 weeks later : ( 1 ) for evaluation of physical fitness : VO2max , muscular endurance , joint mobility and body fat ; ( 2 ) for evaluation of the lipidemic profile : triglyceride , total cholesterol , HDL and LDL levels , and ( 3 ) levels of hormones associated with lactation : prolactin , estradiol , cortisol , TSH , fT3 and fT4 .
RESULTS	After completion of the exercise training program , comparisons between the interventional and the control group showed statistically significant mean changes in VO2max ( p = 0.003 ) , muscular endurance of the upper extremities ( p < 0.001 ) , and the abdomen ( p < 0.001 ) , flexibility ( p = 0.042 ) , and body fat ( p = 0.007 ) .
RESULTS	There were no significant differences between the two groups in mean changes of lipid and hormone levels .
CONCLUSIONS	Implementation of a low-impact exercise training program appears to improve physical fitness of postpartum women , while it does not seem to affect lipid levels and lactation-associated hormone levels .
CONCLUSIONS	Hence , implementation of an exercise training program combining low-impact dance aerobic , resistance and stretching exercise is feasible in postpartum , primiparous , lactating women .

###25552575
OBJECTIVE	To investigate the effects of intensive blood pressure ( BP ) lowering according to baseline BP levels and optimal achieved BP levels in patients with acute intracerebral hemorrhage ( ICH ) .
METHODS	INTERACT2 was an open , blinded endpoint , randomized controlled trial in 2,839 patients with ICH within 6 hours of onset and elevated systolic BP ( SBP ) ( 150-220 mm Hg ) who were allocated to receive intensive ( target SBP < 140 mm Hg within 1 hour , with lower limit of 130 mm Hg for treatment cessation ) or guideline-recommended ( target SBP < 180 mm Hg ) BP-lowering treatment .
METHODS	Outcome was physical function across all 7 levels of the modified Rankin Scale at 90 days .
RESULTS	Analysis of the randomized comparisons showed that intensive BP lowering produced comparable benefits on physical function at 90 days in 5 subgroups defined by baseline SBP of < 160 , 160-169 , 170-179 , 180-189 , and 190 mm Hg ( p homogeneity = 0.790 ) .
RESULTS	Analyses of achieved BP showed linear increases in the risk of physical dysfunction for achieved SBP above 130 mm Hg for both hyperacute ( 1-24 hours ) and acute ( 2-7 days ) phases while modest increases were also observed for achieved SBP below 130 mm Hg .
CONCLUSIONS	Intensive BP lowering appears beneficial across a wide range of baseline SBP levels , and target SBP level of 130-139 mm Hg is likely to provide maximum benefit in acute ICH .
METHODS	This study provides Class I evidence that the effect of intensive BP lowering on physical function is not influenced by baseline BP .

###24812901
OBJECTIVE	To observe the effect of Qiju Dihuang Pill ( QDP ) on changes of Chinese medical syndrome types in pregnant women of Gan-Shen yin deficiency syndrome ( GSYDS ) , and to explore the correlation between imbalanced cytokine levels and GSYDS .
METHODS	This was a random controlled trail .
METHODS	A total of 163 pregnant women of GSYDS at 12 -16 gestational weeks were randomly allocated into the experimental group ( 86 cases ) and the control group ( 77 cases ) .
METHODS	Patients in the experimental group took QDP for 2 -4 weeks .
METHODS	Changes of Chinese medical syndrome types and serum interferon-gamma ( IFN-gamma ) and interleukin-4 ( IL-4 ) levels were observed and compared between the two groups before and after treatment .
RESULTS	( 1 ) Totally 41 patients ( 47.7 % ) in the experimental group were transformed to normal Chinese medical syndrome type .
RESULTS	In the same period of the follow-ups , 9 patients ( 11.7 % ) in the control group were transformed to normal Chinese medical syndrome type , showing statistical difference ( P < 0.05 ) .
RESULTS	( 2 ) In the experimental group , the serum level of IFN-gamma and the ratio of IFN-gamma/IL -4 in the peripheral blood were obviously lower after treatment than before treatment ( P < 0.01 ) , and obviously lower than those in the control group ( P < 0.01 ) .
RESULTS	The level of IL-4 after treatment in the experimental group was higher than that before treatment , and also higher than that in the control group , but with no statistical difference .
CONCLUSIONS	These results indicated that there was imbalanced IFN-gamma/IL -4 ratio in the peripheral blood of pregnant women of GSYDS .
CONCLUSIONS	QDP might play a role in immunoregulation by affecting the IFN-gamma level .

###24607301
OBJECTIVE	The aim of this study was to compare the effect of two energy-restricted , differing with regard to protein content , on the inflammation state of obese individuals with features of metabolic syndrome .
METHODS	Ninety-six participants completed an 8-wk randomized intervention trial that compared the RESMENA diet ( -30 % energy , with 30 % energy from protein ) with a control diet ( -30 % energy , with 15 % energy from protein ) that was based on American Heart Association criteria .
RESULTS	The mean body weight losses were 7.09 0.82 kg and 6.73 0.71 kg , respectively , with no differences seen between the groups .
RESULTS	The endpoint inflammation score-which was based on high-sensitivity C-reactive protein , interleukin-6 , tumor necrosis factor - , and plasminogen activator inhibitor-1 levels-was significantly lower ( P = 0.012 ) in the low-protein group ( 6.81 2.32 versus 7.94 1.94 ) .
RESULTS	The linear regression analyses revealed that total protein intake was positively associated with inflammation ( P = 0.007 ) as well as with animal protein ( P = 0.025 ) and meat protein ( P = 0.015 ) , but neither vegetable - nor fish-derived proteins were found to influence inflammatory status .
CONCLUSIONS	Our results suggest that the type of protein consumed ( more than the total protein consumed ) within an energy-restricted diet influences the inflammation status associated with obesity-related comorbidities .

###25264972
OBJECTIVE	Loneliness enhances risk for episodic memory declines over time .
OBJECTIVE	Omega-3 supplementation can improve cognitive function for people experiencing mild cognitive difficulties .
OBJECTIVE	Accordingly , we explored whether omega-3 supplementation would attenuate loneliness-related episodic memory problems .
METHODS	Participants ( n = 138 ) from a parent randomized controlled trial were randomized to the placebo , 1.25 grams/d of omega-3 , or 2.50 grams/d of omega-3 conditions for a 4-month period .
METHODS	They completed a baseline loneliness questionnaire and a battery of cognitive tests both at baseline and at the end of the randomized controlled trial .
RESULTS	After adjustment for baseline verbal episodic memory scores , lonelier people within the placebo condition had poorer verbal episodic memory postsupplementation , as measured by immediate ( b = -0.28 , t ( 117 ) = -2.62 , p = .010 ) and long-delay ( b = -0.06 , t ( 116 ) = -2.07 , p = .040 ) free recall , than their less lonely counterparts .
RESULTS	This effect was not observed in the 1.25 - and 2.50-grams / d supplementation groups ( all p values > .10 ) .
RESULTS	The plasma omega-6 : omega-3 ratio data mirrored these results .
RESULTS	There were no loneliness-related effects of omega-3 supplementation on short-delay recall or the other cognitive tests ( all p values > .32 ) .
CONCLUSIONS	These results suggest that omega-3 supplementation attenuates loneliness-related verbal episodic memory declines over time and support the use of exploring novel interventions for treating episodic memory problems among lonely people .
BACKGROUND	clinicaltrials.gov Identifier : NCT00385723 .

###25266831
OBJECTIVE	To evaluate the effect of surgical factors on postoperative astigmatism in infants undergoing cataract extraction with or without intraocular lens ( IOL ) implantation .
METHODS	The Infant Aphakia Treatment Study is a multicenter clinical trial in which 114 infants with unilateral congenital cataracts were randomized to undergo cataract extraction with IOL placement or contact lens aphakic correction .
METHODS	Surgical videos were reviewed with regard to incision type and location , whether the incision was extended , the number of sutures placed , and technique of closure .
METHODS	Corneal astigmatism was measured using a handheld keratometer prior to surgery and at 1 year of age .
RESULTS	Corneal astigmatism decreased from a mean of 1.92 D at baseline to 1.62 D at age 1 year in the contact lens group but remained almost unchanged from 2.00 D to 2.09 D in the IOL group ( P = 0.023 ) .
RESULTS	There was no statistical difference between the amount of corneal astigmatism with regard to incision type ( P = 0.214 ) and no increase in astigmatism with extension of the incision to facilitate IOL placement ( P = 0.849 ) at 1 year .
RESULTS	The number of sutures and technique of closure did not influence the amount of astigmatism at 1 year .
CONCLUSIONS	At the age of 1 year following cataract extraction in infants , contact lens correction and the lack of IOL placement are associated with a significant decrease in postoperative corneal astigmatism compared to IOL placement .
CONCLUSIONS	No other surgical factors considered in this study had a statistically significant effect on corneal astigmatism .

###25624435
OBJECTIVE	This study assessed the efficacy of a 38-hour communication skills training program designed to train a multidisciplinary radiotherapy team .
METHODS	Four radiotherapy teams were randomly assigned to a training program or a waiting list .
METHODS	Assessments were scheduled at baseline and after training for the training group and at baseline and 4 months later for the waiting list group .
METHODS	Assessments included an audio recording of a radiotherapy planning session to assess team members ' communication skills and expression of concerns of patients with breast cancer ( analyzed with content analysis software ) and an adapted European Organisation for Research and Treatment of Cancer satisfaction with care questionnaire completed by patients at the end of radiotherapy .
RESULTS	Two hundred thirty-seven radiotherapy planning sessions were recorded .
RESULTS	Compared with members of the untrained teams , members of the trained teams acquired , over time , more assessment skills ( P = .003 ) and more supportive skills ( P = .050 ) and provided more setting information ( P = .010 ) .
RESULTS	Over time , patients interacting with members of the trained teams asked more open questions ( P = .022 ) , expressed more emotional words ( P = .025 ) , and exhibited a higher satisfaction level regarding nurses ' interventions ( P = .028 ) .
CONCLUSIONS	The 38-hour training program facilitated transfer of team member learned communication skills to the clinical practice and improved patients ' satisfaction with care .

###24519693
OBJECTIVE	Although selective serotonin reuptake inhibitors are now established as first-line pharmacotherapy for social anxiety disorder ( SAD ) , other agents with different mechanisms have shown promise in treating SAD .
OBJECTIVE	The aim of this study was to examine the efficacy and safety of tandospirone in treating adolescents with SAD .
METHODS	Adolescent patients meeting the Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition ( DSM-IV ) criteria for SAD were randomly assigned ( 1:1 ) to open-label treatment with either tandospirone or sertraline for 8weeks .
METHODS	The primary outcome measures were changes from baseline in the Hamilton Anxiety ( HAM-A ) scale and response using the Clinical Global Impression of Improvement ( CGI-I ) scale .
RESULTS	The adjusted mean change in HAM-A scores from baseline was indicating a significant improvement over baseline in both treatment arms ( p < 0.0001 ) .
RESULTS	The mean CGI-I scale score at week was with no significant difference between the two arms ( p = 0.42 ) .
RESULTS	Rates of response were 48.6 % for tandospirone and 55.6 % for sertraline using the CGI-I .
RESULTS	Response rates were 37.1 % for tandospirone and 41.7 % for sertraline using a HAM-A response criterion ( 50 % reduction ) .
RESULTS	The adjusted mean change in Social Phobia Inventory scores from baseline was indicating a significant improvement over baseline in both treatment arms ( p < 0.0001 ) .
CONCLUSIONS	Tandospirone is safe and effective and appears non-inferior to sertraline for SAD in youths .

###24841774
OBJECTIVE	The CAREvent Public Access Resuscitator ( PAR ) is an electronic , oxygen-driven cardiopulmonary resuscitation ( CPR ) device allowing volume-controlled ventilation with a face mask and guiding the rescuer through the resuscitation with voice prompts and visual indications .
OBJECTIVE	We hypothesized that 1 year after initial training , the efficacy of ventilation skills ( primary outcome ) and compression skills ( secondary outcome ) by first responders using the PAR would be superior compared with CPR with only a face mask .
METHODS	Seventy-one first responders were randomized to a group using the PAR ( n = 35 ) and a control group using only a face mask ( n = 36 ) .
METHODS	CPR skills were assessed immediately after training and after 3 , 7 and 12 months using a Skill Reporter manikin .
METHODS	Differences between groups over time and the interaction between time and groups were assessed using repeated measures models .
METHODS	Results are reported as mean values and number of participants with good ventilation or compression skills .
RESULTS	Twelve months after training , there were more PAR users with adequate tidal volume than face mask users .
RESULTS	Other ventilations skills did not differ between groups .
RESULTS	There were more PAR users with an adequate number of compressions and with good hand position .
RESULTS	Skill decay over 12 months did not differ between groups , except for hand position , where no decline was observed in the PAR group .
CONCLUSIONS	Compared with the face mask , PAR improved tidal volume , compressions per minute and hand position in a manikin setting .

###24248551
BACKGROUND	Metatarsus adductus is a common pediatric foot deformity related to intrauterine molding .
BACKGROUND	It is usually a mild deformity that responds well to simple observation or minimal treatment with a home program of stretching .
BACKGROUND	Resistant cases may need a more aggressive approach such as serial casting or special bracing to avoid the need for surgical intervention .
BACKGROUND	We compared clinical outcomes using serial casting with orthoses for resistant metatarsus adductus .
METHODS	We prospectively treated 27 infants ( 43 feet ) between the ages 3 and 9 months who failed home stretching treatment .
METHODS	Patients were randomized to either serial plaster casting or Bebax orthoses .
METHODS	Footprints and simulated weight-bearing anteroposterior and lateral view radiographs were made at entry and follow-up .
RESULTS	There was no statistical difference between casting and Bebax for the following parameters : age at study entry , length of treatment , number of clinic visits , follow-up , and follow-up maintenance treatments .
RESULTS	Both groups showed improvement in footprint and radiographic measurements post-treatment , without worsening of heel valgus .
RESULTS	The Bebax group had greater improvement in the footprint heel bisector measurement than the casting group .
RESULTS	The Bebax treatment requires more active parental cooperation .
RESULTS	A simulated cost analysis of materials and office visit charges , however , revealed that Bebax treatment was significantly less expensive , about half the cost of casting .
CONCLUSIONS	Because of the cost savings and virtually identical clinical results , we recommend the Bebax orthosis for resistant metatarsus in pre-walking infants with parents who are compliant .
CONCLUSIONS	Other considerations include specific insurance plans , which may pay for casts but not orthoses .

###25137867
OBJECTIVE	The aim was to compare the hemodynamic parameters , intubation times , upper airway trauma and postoperative sore throat scores of the patients with normal airway anatomy , intubated with the Airtraq , Macintosh laryngoscope and fiberoptic bronchoscope , by experienced anesthesiologists .
METHODS	Ninety patients , scheduled to undergo elective surgery under general anesthesia were randomly divided into three groups ( n = 30 ) : Group A : Airtraq laryngoscope , Group M : Macintosh laryngoscope and Group FB : fiberoptic bronchoscope .
METHODS	The time to intubation and success rates were recorded .
METHODS	The hemodynamic parameters before and one minute after the anesthesia induction were recorded and the measurements were repeated 3 , 4 and 5 minutes after the endotracheal intubation .
METHODS	The postoperative sore throat scores and signs of any trauma were also recorded .
RESULTS	Mean arterial blood pressure and heart rate were not significantly different between the three groups .
RESULTS	The mean intubation time interval did not differ between groups .
RESULTS	Highest postoperative sore throat scores were recorded at the 6th hour post extubation .
RESULTS	The scores were 37.6 + / - 20.9 in Group A , 13.3 + / - 16.8 in Group M and 13.6 + / - 14.0 in Group FB .
RESULTS	The scores in Group A were significantly higher compared to other groups .
RESULTS	The number of patients requiring additional analgesia to relieve sore throat was also significantly higher in Group A.
CONCLUSIONS	The Airtraq laryngoscope seems to be a more traumatic airway device in the routine endotracheal intubation compared to Macintosh laryngoscope and fiberoptic bronchoscope , when used by experienced anesthesiologists .
CONCLUSIONS	It also does not offer advantage over the first-attempt success rates , the intubation times and hemodynamic parameters .

###24286335
BACKGROUND	Oncostatin M ( OSM ) has been implicated in the pathophysiology of rheumatoid arthritis ( RA ) through its effect on inflammation and joint damage .
BACKGROUND	GSK315234 is a humanised anti-OSM Immunoglobulin G1 ( IgG1 ) monoclonal antibody ( mAb ) .
BACKGROUND	This 3-part study examines the safety , tolerability and efficacy of GSK315234 in patients with active RA .
METHODS	This was a 3-part ( Parts A , B and C ) , multicenter study .
METHODS	Part A and Part B were randomised , double-blind , placebo-controlled , Bayesian adaptive dose finding studies to investigate the safety , tolerability , efficacy , pharmacokinetics and pharmacodynamics of single ( Part A ) and 3 repeat ( Part B ) intravenous infusions of GSK315234 in patients with active RA on a background of methotrexate ( MTX ) .
METHODS	Part C was a single dose , randomised , single-blind , placebo-controlled study to assess subcutaneously administered GSK315234 to patients with active RA on a background of MTX .
RESULTS	The primary endpoint of the study was mean change in DAS28 at Day 28 in Part A and Day 56 in Part B and C. All patients receiving at least one dose of GSK315234 were included in safety analysis .
RESULTS	In Part A , there were statistically significant differences in DAS28 between 3 mg/kg and placebo at Day 56 , 84 and 91 .
RESULTS	There was also a statistically significant difference in DAS28 between 0.3 mg/kg , 3 mg/kg and 10 mg/kg , as compared to placebo , at Day 84 .
RESULTS	Although these changes were small and occurred late , they supported progression to Part B and C to determine the therapeutic potential of GSK315234 .
RESULTS	For Part B , no significant difference was observed between 6 mg/kg and placebo .
RESULTS	For Part C , a statistically significant difference in DAS28 was observed at Day 40 , Day 84 and Day 100 between the 500 mg subcutaneous group , as compared to placebo .
RESULTS	No significant findings were observed at any of the time points for EULAR response criteria , ACR20 , ACR50 or ACR70 .
RESULTS	An exploratory analysis of clinical , pharmacokinetic and pharmacodynamics data suggests the lack of efficacy may be due to moderate binding affinity and rapid off-rate of GSK315234 as compared to the higher affinity OSM receptor causing a protein carrier effect prolonging the half life of OSM due to accumulation of the OSM/antibody complex in the serum and synovial fluid .
CONCLUSIONS	Our data highlighted the importance of binding affinity and off-rate effect of a mAb to fully neutralize the target and how this may influence its efficacy and potentially worsen disease activity .
CONCLUSIONS	Using an anti-OSM mAb with high affinity should test this hypothesis and examine the potential of OSM as a therapeutic target in RA .
BACKGROUND	ClinicalTrials.gov no : NCT00674635 .

###25004983
BACKGROUND	Screening can reduce colorectal cancer ( CRC ) incidence and mortality .
BACKGROUND	However , screening is underutilized in vulnerable patient populations , particularly among Latinos .
BACKGROUND	Patient-directed decision aids can increase CRC screening knowledge , self-efficacy , and intent ; however , their effect on actual screening test completion tends to be modest .
BACKGROUND	This is probably because decision aids do not address some of the patient-specific barriers that prevent successful completion of CRC screening in these populations .
BACKGROUND	These individual barriers might be addressed though patient navigation interventions .
BACKGROUND	This study will test a combined decision aid and patient navigator intervention on screening completion in diverse populations of vulnerable primary care patients .
METHODS	We will conduct a multisite , randomized controlled trial with patient-level randomization .
METHODS	Planned enrollment is 300 patients aged 50 to 75years at average CRC risk presenting for appointments at two primary clinics in North Carolina and New Mexico .
METHODS	Intervention participants will view a video decision aid immediately before the clinic visit .
METHODS	The 14 to 16minute video presents information about fecal occult blood tests and colonoscopy and will be viewed on a portable computer tablet in English or Spanish .
METHODS	Clinic-based patient navigators are bilingual and bicultural and will provide both face-to-face and telephone-based navigation .
METHODS	Control participants will view an unrelated food safety video and receive usual care .
METHODS	The primary outcome is completion of a CRC screening test at six months .
METHODS	Planned subgroup analyses include examining intervention effectiveness in Latinos , who will be oversampled .
METHODS	Secondarily , the trial will evaluate the intervention effects on knowledge of CRC screening , self-efficacy , intent , and patient-provider communication .
METHODS	The study will also examine whether patient ethnicity , acculturation , language preference , or health insurance status moderate the intervention effect on CRC screening .
CONCLUSIONS	This pragmatic randomized controlled trial will test a combined decision aid and patient navigator intervention targeting CRC screening completion .
CONCLUSIONS	Findings from this trial may inform future interventions and implementation policies designed to promote CRC screening in vulnerable patient populations and to reduce screening disparities .
BACKGROUND	ClinicalTrials.gov NCT02054598 .

###25490971
BACKGROUND	Diarrhoea and pneumonia contribute 30 % of deaths in children under 5 in Pakistan .
BACKGROUND	Pakistan 's Lady Health Workers Programme ( LHW-P ) covers about 60 % of the population but has had little impact in reducing morbidity and mortality related to these major childhood killers .
BACKGROUND	An external evaluation of the LHW-P suggests that lack of supportive supervision of LHWs by lady health supervisors ( LHSs ) is a key determinant of this problem .
BACKGROUND	Project NIGRAAN aims to improve knowledge and skills of LHWs and community caregivers through supervisory strategies employed by LHSs .
BACKGROUND	Ultimately , community case management ( CCM ) of childhood pneumonia and diarrhoea will improve .
METHODS	NIGRAAN is a cluster-randomised trial in District Badin , Pakistan .
METHODS	There are approximately 1100 LHWs supervised by 36 LHSs in Badin .
METHODS	For this study , each LHS serves as a cluster .
METHODS	All LHSs working permanently in Badin who regularly conduct and report field visits are eligible .
METHODS	Thirty-four LHSs have been allocated to either intervention or control arms in a ratio of 1:1 through computer-generated simple randomisation technique .
METHODS	Five LHWs from each LHSs are also randomly picked .
METHODS	All 34 LHSs and 170 LHWs will be actively monitored .
METHODS	The intervention consists of training to build LHS knowledge and skills , clinical mentorship and written feedback to LHWs .
METHODS	Pre - and post-intervention assessments of LHSs , LHWs and community caregivers will be conducted via focus group discussions , in-depth interviews , knowledge assessment questionnaires , skill assessment scorecards and household surveys .
METHODS	Primary outcome is improvement in CCM practices of childhood diarrhoea and pneumonia and will be assessed at the cluster level .
CONCLUSIONS	NIGRAAN takes a novel approach to implementation research and explores whether training of LHSs in supervisory skills results in improving the CCM practices of childhood diarrhoea and pneumonia .
CONCLUSIONS	No significant harm to participants is anticipated .
CONCLUSIONS	The enablers and barriers towards improved CCM would provide recommendations to policymakers for scale up of this intervention nationally and regionally .
BACKGROUND	NIGRAAN is registered with the ` Australian New Zealand Clinical Trials Registry ' .
BACKGROUND	ACTRN12613001261707 .

###24316712
OBJECTIVE	To evaluate and compare peri-implant health , marginal bone loss and success of immediate and delayed implant placement for rehabilitation with full-arch fixed prostheses .
METHODS	The present study was a prospective , randomized , single-blind , clinical preliminary trial .
METHODS	Patients were randomized into two treatment groups .
METHODS	In Group A implants were placed immediately post-extraction and in Group B six months after extraction .
METHODS	The following control time-points were established : one week , six months and twelve months after loading .
METHODS	Measurements were taken of peri-implant crevicular fluid volume , plaque index , gingival retraction , keratinized mucosa , probing depth , modified gingival index and presence of mucositis .
METHODS	Implant success rates were evaluated for the two groups .
METHODS	The study sample included fifteen patients ( nine women and six men ) with a mean average age of 63.7 years .
METHODS	One hundred and forty-four implants were placed : 76 placed in healed sites and 68 placed immediately .
RESULTS	At the moment of prosthetic loading , keratinized mucosa width and probing depth were higher in immediate implants than delayed implants , with statistically significant differences .
RESULTS	However , after six and twelve months , differences between groups had disappeared .
RESULTS	Bone loss was 0.54 0.39 mm for immediate implants and 0.66 0.25 mm for delayed implants ( p = 0.201 ) .
RESULTS	No implants failed in either group .
CONCLUSIONS	The present study with a short follow-up and a small sample yielded no statistically significant differences in implant success and peri-implant marginal bone loss between immediate and delayed implants with fixed full-arch prostheses .
CONCLUSIONS	Peri-implant health showed no statistically significant differences for any of the studied parameters ( crevicular fluid volume , plaque index , gingival retraction , keratinized mucosa , probing depth , modified gingival index and presence of mucositis ) at the twelve-month follow-up .

###25112010
OBJECTIVE	To observe the effect of postoperative analgesia with dexmedetomidine on the survival rate of amputated finger replantation .
METHODS	91 cases , who was going to receive amputated finger replantation , were randomly divided into group A ( n = 48 ) and B ( n = 43 ) .
METHODS	PCIA ( patient-controlled intravenous analgesia ) was set immediately after operation in group A ( fentanyl 1.0 mg + tropisetron 4.0 mg + 10 mg + dexmedetomidine 200 microg + saline 100 ml ) and group B ( same as group A except dexmedetomidine ) .
METHODS	Background infusion is 2 ml/h with a bolous of 0.5 ml and lockout time is 15 min .
METHODS	postoperative VAS score , Ramsay score , condition of replanted fingers and other adverse events at the 0-6 h , 6-12 h , 12-24 h and 24-48 h were recorded and analyzed .
RESULTS	The age , sex , height , weight , amputated time ( Ts ) , revascularized time ( Tt ) in the two groups were not statistically different ( P > 0.05 ) .
RESULTS	Postoperative VAS score in the two groups was significantly different at the 0-6 h , 6-12 h , 12-24 h and 24-48 h ( P < 0.05 ) , but Ramsay score was not ( P > 0.05 ) .
RESULTS	The highest and lowest postoperative VAS score and Ramsay score were markedly different between two groups ( P < 0.05 ) .
RESULTS	3 of the 60 fingers in group A experienced vascular crisis and 2 underwent vascular explore surgery .
RESULTS	13 of 56 fingers in group B occurred vascular crisis , and 10 underwent vascular explore surgery , showing significant difference between the two groups ( P < 0.05 ) .
RESULTS	PCIA adverse reactions showed no difference between the two groups ( P > 0.05 ) .
RESULTS	Bradycardia and hypotension did n't happen in any patients in the two groups .
RESULTS	4 weeks after surgery , the survival rate was 96.7 % ( 58/60 ) in group A , and 83.9 % ( 47/56 ) in group B ( P < 0.05 ) .
CONCLUSIONS	Postoperative analgesia with dexmedetomidine as an adjuvant can increase the survival rate of replantation fingers with high safety .

###25795406
BACKGROUND	Trabectedin binds to the minor groove of DNA and blocks DNA repair machinery .
BACKGROUND	Preclinical data have shown that trabectedin also modulates the transcription of the oncogenic fusion proteins of translocation-related sarcomas .
BACKGROUND	We aimed to assess the efficacy and safety of trabectedin as second-line therapy or later for patients with advanced translocation-related sarcoma .
METHODS	We did a multicentre randomised open-label study in Japan .
METHODS	Eligible patients had pathological diagnosis of translocation-related sarcoma , were aged 19 years or older , were unresponsive or intolerant to standard chemotherapy regimens , no more than four previous chemotherapy regimens , Eastern Cooperative Oncology Group performance status 0 or 1 , adequate bone marrow reserve , renal and liver functions , and had measurable lesions .
METHODS	Patients were randomly assigned ( 1:1 ) by the minimisation method to receive either trabectedin ( 12 mg/m ( 2 ) given via a central venous line over 24 h on day 1 of a 21 day treatment cycle ) or best supportive care , which was adjusted centrally by pathological subtype .
METHODS	Investigators , patients , and the sponsor were unmasked to the treatment assignment .
METHODS	Progression-free survival and objective responses were assessed by a masked central radiology imaging review .
METHODS	Efficacy was assessed by masked central radiology imaging review .
METHODS	The primary endpoint was progression-free survival for the full analysis set population .
METHODS	Follow-up is ongoing for the patients under study treatment .
METHODS	The study is registered with Japan Pharmaceutical Information Center , number JapicCTI-121850 .
RESULTS	Between July 11 , 2012 , and Jan 20 , 2014 , 76 patients were enrolled and allocated to receive either trabectedin ( n = 39 ) or best supportive care ( n = 37 ) .
RESULTS	After central review to confirm pathological subtypes , 73 patients ( 37 in the trabectedin group and 36 in the best supportive care group ) were included in the primary efficacy analysis .
RESULTS	Median progression-free survival of the trabectedin group was 56 months ( 95 % CI 41-75 ) and the best supportive care group was 09 months ( 07-10 ) .
RESULTS	The hazard ratio ( HR ) for progression-free survival of trabectedin versus best supportive care was 007 ( 90 % CI 003-014 and 95 % CI 003-016 ) by a Cox proportional hazards model ( p < 00001 ) .
RESULTS	The most common drug-related adverse events for patients treated with trabectedin were nausea ( 32 [ 89 % ] of 36 ) , decreased appetite ( 21 [ 58 % ] ) , decreased neutrophil count ( 30 [ 83 % ] ) , increased alanine aminotransferase ( 24 [ 67 % ] ) , and decreased white blood cell count ( 20 [ 56 % ] ) .
CONCLUSIONS	Trabectedin significantly reduced the risk of disease progression and death in patients with advanced translocation-related sarcoma after standard chemotherapy such as doxorubicin , and should be considered as a new therapeutic treatment option for this patient population .
BACKGROUND	Taiho Pharmaceutical Co. , Ltd. .

###24679061
BACKGROUND	Marked activation of the sympathetic nervous system occurs during and after noncardiac surgery .
BACKGROUND	Low-dose clonidine , which blunts central sympathetic outflow , may prevent perioperative myocardial infarction and death without inducing hemodynamic instability .
METHODS	We performed a blinded , randomized trial with a 2-by-2 factorial design to allow separate evaluation of low-dose clonidine versus placebo and low-dose aspirin versus placebo in patients with , or at risk for , atherosclerotic disease who were undergoing noncardiac surgery .
METHODS	A total of 10,010 patients at 135 centers in 23 countries were enrolled .
METHODS	For the comparison of clonidine with placebo , patients were randomly assigned to receive clonidine ( 0.2 mg per day ) or placebo just before surgery , with the study drug continued until 72 hours after surgery .
METHODS	The primary outcome was a composite of death or nonfatal myocardial infarction at 30 days .
RESULTS	Clonidine , as compared with placebo , did not reduce the number of primary-outcome events ( 367 and 339 , respectively ; hazard ratio with clonidine , 1.08 ; 95 % confidence interval [ CI ] , 0.93 to 1.26 ; P = 0.29 ) .
RESULTS	Myocardial infarction occurred in 329 patients ( 6.6 % ) assigned to clonidine and in 295 patients ( 5.9 % ) assigned to placebo ( hazard ratio , 1.11 ; 95 % CI , 0.95 to 1.30 ; P = 0.18 ) .
RESULTS	Significantly more patients in the clonidine group than in the placebo group had clinically important hypotension ( 2385 patients [ 47.6 % ] vs. 1854 patients [ 37.1 % ] ; hazard ratio 1.32 ; 95 % CI , 1.24 to 1.40 ; P < 0.001 ) .
RESULTS	Clonidine , as compared with placebo , was associated with an increased rate of nonfatal cardiac arrest ( 0.3 % [ 16 patients ] vs. 0.1 % [ 5 patients ] ; hazard ratio , 3.20 ; 95 % CI , 1.17 to 8.73 ; P = 0.02 ) .
CONCLUSIONS	Administration of low-dose clonidine in patients undergoing noncardiac surgery did not reduce the rate of the composite outcome of death or nonfatal myocardial infarction ; it did , however , increase the risk of clinically important hypotension and nonfatal cardiac arrest .
CONCLUSIONS	( Funded by the Canadian Institutes of Health Research and others ; POISE-2 ClinicalTrials.gov number , NCT01082874 . )

###24655705
BACKGROUND	Right ventricular ( RV ) outflow tract obstruction ( RVOTO ) might protect the RV from adverse remodeling caused by significant pulmonary regurgitation ( PR ) in patients with repaired tetralogy of Fallot ( rTOF ) , but the underlying mechanisms and influences on exercise tolerance remain unclear .
BACKGROUND	This study sought to investigate the impacts from mild RVOTO on ventricular remodeling and exercise capacity in rTOF .
METHODS	Eighty-five rTOF patients with a PR fraction 20 % were assessed with cardiac magnetic resonance , cardiopulmonary exercise test , and echocardiography .
METHODS	Patients with a peak RVOT pressure gradient 20-50 mmHg were considered to have mild RVOTO ( n = 29 ) , while those with a gradient < 20 mmHg had isolated PR ( n = 56 ) .
RESULTS	Comparing to patients with isolated PR , patients with combined PR and mild RVOTO had smaller RV and RVOT dimension , better RV and left ventricular ( LV ) ejection fraction ( EF ) , and superior exercise capacity .
RESULTS	PR severity and RV mass/volume ratio were similar between these 2 groups .
RESULTS	LVEF coupled with RVEF only in patients with isolated PR .
RESULTS	In multivariate analysis , smaller RVOT dimension was independently related to smaller RV dimension ( P < .001 ) and higher RVEF ( P = .005 ) .
RESULTS	Furthermore , mild RVOTO was independently associated with higher peak oxygen consumption ( P = .014 ) and oxygen uptake efficiency slope ( P = .005 ) .
CONCLUSIONS	Patients with combined PR and mild RVOTO had better RV remodeling and exercise capacity compared to those with isolated PR .
CONCLUSIONS	Our findings confirm the benefits from mild residual RVOTO support a policy of conservative RVOTO relief at repair .

###24310562
OBJECTIVE	Muscle mitochondrial function can vary during fasting , but is lower during hyperinsulinaemia in insulin-resistant humans .
OBJECTIVE	Ageing and hyperlipidaemia may be the culprits , but the mechanisms remain unclear .
OBJECTIVE	We hypothesised that ( 1 ) insulin would fail to increase mitochondrial oxidative capacity in non-diabetic insulin-resistant young obese humans and in elderly patients with type 2 diabetes and ( 2 ) reducing NEFA levels would improve insulin sensitivity by raising oxidative capacity and lowering oxidative stress .
METHODS	Before and after insulin ( 4 , 40 , 100 nmol/l ) stimulation , mitochondrial oxidative capacity was measured in permeabilised fibres and isolated mitochondria using high-resolution respirometry , and H2O2 production was assessed fluorimetrically .
METHODS	Tissue-specific insulin sensitivity was measured with hyperinsulinaemic-euglycaemic clamps combined with stable isotopes .
METHODS	To test the second hypothesis , in a 1-day randomised , crossover study , 15 patients with type 2 diabetes recruited via local advertisement were assessed for eligibility .
METHODS	Nine patients fulfilled the inclusion criteria ( BMI < 35 kg/m ( 2 ) ; age < 65 years ) and were allocated to and completed the intervention , including oral administration of 750 mg placebo or acipimox .
METHODS	Blinded randomisation was performed by the pharmacy ; all participants , researchers performing the measurements and those assessing study outcomes were blinded .
METHODS	The main outcome measures were insulin sensitivity , oxidative capacity and oxidative stress .
RESULTS	Insulin sensitivity and mitochondrial oxidative capacity were ~ 31 % and ~ 21 % lower in the obese groups than in the lean group .
RESULTS	The obese participants also exhibited blunted substrate oxidation upon insulin stimulation .
RESULTS	In the patients with type 2 diabetes , acipimox improved insulin sensitivity by ~ 27 % and reduced H2O2 production by ~ 45 % , but did not improve basal or insulin-stimulated mitochondrial oxidative capacity .
RESULTS	No harmful treatment side effects occurred .
CONCLUSIONS	Decreased mitochondrial oxidative capacity can also occur independently of age in insulin-resistant young obese humans .
CONCLUSIONS	Insulin resistance is present at the muscle mitochondrial level , and is not affected by reducing circulating NEFAs in type 2 diabetes .
CONCLUSIONS	Thus , impaired plasticity of mitochondrial function is an intrinsic phenomenon that probably occurs independently of lipotoxicity and reduced glucose uptake .
BACKGROUND	Clinical Trials NCT00943059 FUNDING : This study was funded in part by a grant from the German Federal Ministry of Education and Research to the German Center for Diabetes Research ( DZD e.V. ) .

###24468257
BACKGROUND	Hereditary angioedema ( HAE ) , caused by C1 inhibitor ( C1INH ) deficiency or dysfunction , is characterized by recurrent attacks of tissue swelling affecting multiple anatomic locations .
BACKGROUND	Recombinant human C1INH ( rhC1INH ) has been shown effective for acute treatment of HAE attacks .
OBJECTIVE	To evaluate the efficacy and safety of rhC1INH ( 50 IU/kg to maximum 4,200 IU/treatment ) vs placebo in a larger HAE population .
METHODS	Seventy-five patients experiencing peripheral , abdominal , facial , and/or oropharyngeal laryngeal attacks were randomized ( 3:2 ) to rhC1INH ( n = 44 ) or placebo ( saline ; n = 31 ) .
METHODS	Efficacy was assessed bypatient responses on a Treatment Effect Questionnaire ( TEQ ) and visual analog scale ( VAS ) .
METHODS	Safety also was evaluated .
RESULTS	Median ( 95 % confidence interval ) time to beginning of symptom relief at the primary attack location was 90 minutes ( 61-150 ) in rhC1INH-treated patients vs 152 minutes ( 93 , not estimable ) in placebo-treated patients ( P = .031 ) based on the TEQ and 75 minutes ( 60-105 ) vs 303 minutes ( 81-720 , P = .003 ) based on a VAS decrease of at least 20 mm .
RESULTS	Median time to minimal symptoms was 303 minutes ( 240-720 ) in rhC1INH-treated patients vs 483 minutes ( 300-1 ,440 ) in placebo-treated patients based on the TEQ ( P = .078 ) and 240 minutes ( 177-270 ) vs 362 minutes ( 240 , not estimable ; P = .005 ) , based on an overall VAS less than 20 mm .
RESULTS	Overall , rhC1INH was safe and well tolerated ; no thromboembolic events , anaphylaxis , or neutralizing antibodies were observed .
CONCLUSIONS	Relief of symptoms of HAE attacks was achieved faster with rhC1INH compared with placebo as assessed by the TEQ and VAS , with a positive safety profile .
CONCLUSIONS	Results are consistent with previous studies showing efficacy and safety of rhC1INH in patients with HAE .

###24602708
OBJECTIVE	Surgical interns are often not well prepared and have high anxiety about the execution of basic technical skills .
OBJECTIVE	This study investigates whether a short preclinical course focusing on laparoscopic camera-navigating skills is useful in the preparation for internship .
METHODS	Through randomization , an experimental group who attended a short laparoscopic training session and a control group were created .
METHODS	Students ' interest for this training and their confidence for laparoscopic exposure during surgical internship were inquired .
METHODS	During internship , camera-navigating skills were assessed by the operating surgeons ( using a validated global rating scale ) as well as by the students themselves ( using a 10-points Likert scale ) .
METHODS	All research was performed in the Center for Surgical Technologies , Leuven , Belgium .
METHODS	A total of 205 fifth-year medical students at the University of Leuven , Belgium .
RESULTS	Of the control group students , 80 % were interested in attending the training session .
RESULTS	There was no difference in confidence between experimental and control group .
RESULTS	According to the surgeons and students , there was a significant improvement in clinical performance from the first ( scores on global rating and Likert scales 50 % ) to the last procedure ( scores 70 % ) for both groups .
RESULTS	However , there was no difference in performance between groups .
CONCLUSIONS	Students are very interested in attending a preclinical laparoscopic training session .
CONCLUSIONS	However , trained students did not display higher confidence or better clinical performance during internship .
CONCLUSIONS	Even without previous training , students are fast to acquire the necessary skills during surgical internship .

###25624143
OBJECTIVE	The study was designed to investigate the effects of drenching with propylene glycol ( PG ) on body condition , serum metabolites and milk production during the transition period of dairy buffaloes .
METHODS	Animals were randomly allocated to a control group ( n = 5 ) and a PG group of 10 buffaloes that were drenched with 500 ml of propylene glycol once daily from 10 ( 93 ) days prepartum until 2 weeks postpartum .
METHODS	Ultrasound measurements of backfat thickness ( BFT ) were performed weekly , while blood samples were taken at -4 , -2 , 2 , 4 , 6 , and 8 weeks from parturition for estimation of hematological and biochemical metabolites .
RESULTS	At -4 , -3 , and -2 weeks from calving , BFT did not differ between the two groups , but decreased after calving and was higher for the control group than the PG group at weeks -1 and 1 .
RESULTS	Hematological analysis revealed insignificant changes between the two groups .
RESULTS	Serum concentrations of non-esterified fatty acids ( NEFA ) , - hydroxybutyric acid ( BHBA ) and glucose did not differ between the two groups before parturition .
RESULTS	At 2 and 4 weeks from parturition , NEFA was higher for the control group than the PG group .
RESULTS	Serum concentrations of BHBA were higher at 2 , 4 , 6 , and 8 weeks in control animals than in treated buffaloes .
RESULTS	In contrast , the glucose level was significantly increased in PG group when compared to the control group at week 2 postpartum ( p < 0.05 ) .
RESULTS	Serum concentrations of total cholesterol , triglycerides , total proteins , albumin , and globulins did not differ significantly between the two groups ( p > 0.05 ) .
RESULTS	Serum enzyme activities of aspartate aminotransferase and - glutamyl transferase were significantly higher in the control than in the PG group .
RESULTS	In treated buffaloes significantly ( p < 0.05 ) higher average 60-day milk yields were recorded ( 8.40.22 vs. 10.70.40 kg/day ) .
RESULTS	Milk composition did not differ between the two groups .
CONCLUSIONS	Drenching of dairy buffaloes with propylene glycol may reduce the risk of ketosis , improve the metabolic status , and increase the milk yield .

###24499460
BACKGROUND	Spinal bone metastases are commonly diagnosed in cancer patients .
BACKGROUND	The consequences are pain both at rest and under exercise , impairment of activities of daily life ( ADL ) , reduced clinical performance , the risk of pathological fractures , and neurological deficits .
BACKGROUND	The aim of this randomized , controlled pilot trial was to investigate the feasibility of muscle-training exercises in patients with spinal bone metastases under radiotherapy .
BACKGROUND	Secondary endpoints were local control , pain response and survival .
METHODS	This study was a prospective , randomized , monocentre , controlled explorative intervention trial to determine the multidimensional effects of exercises for strengthening the paravertebral muscles .
METHODS	On the days of radiation treatment , patients in the control group were physically treated in form of respiratory therapy .
METHODS	Sixty patients were randomized between September 2011 and March 2013 into one of the two groups : differentiated resistance training or physical measure with thirty patients in each group .
RESULTS	The resistance training of the paravertebral muscles was feasible in 83.3 % of patients ( n = 25 ) .
RESULTS	Five patients died during the first three months .
RESULTS	The exercise group experienced no measurable side effects .
RESULTS	`` Chair stand test '' in the intervention group was significant enhanced with additionally improved analgesic efficiency .
RESULTS	Patients in intervention group improved in pain score ( VAS , 0-10 ) over the course ( p < .001 ) , and was significant better between groups ( p = .003 ) after 3 months .
RESULTS	The overall pain response showed no significant difference between groups ( p = .158 ) There was no significant difference in overall and bone survival ( survival from first diagnosed bone metastases to death ) .
CONCLUSIONS	Our trial demonstrated safety and feasibility of an isometric resistance training in patients with spinal bone metastases .
CONCLUSIONS	The results offer a rationale for future large controlled investigations to confirm these findings .

###25254489
BACKGROUND	N-acetylcysteine ( NAC ) or sodium bicarbonate ( NaHCO3 ) , singly or combined , inconsistently prevent patients exposed to radiographic contrast media from developing contrast-induced acute kidney injury ( CI-AKI ) .
OBJECTIVE	We asked whether intravenous isotonic saline and either NaHCO3 in 5 % dextrose or else a high dose of NAC in 5 % dextrose prevent CI-AKI in outpatients exposed to high-osmolal iodinated contrast medium more than does saline alone .
METHODS	This completed prospective , parallel , superiority , open-label , controlled , computer-randomized , single-center , Brazilian trial ( NCT01612013 ) hydrated 500 adult outpatients ( 214 at high risk of developing CI-AKI ) exposed to ioxitalamate during elective coronary angiography and ventriculography .
METHODS	From 1 hour before through 6 hours after exposure , 126 patients ( group 1 ) received a high dose of NAC and saline , 125 ( group 2 ) received NaHCO3 and saline , 124 ( group 3 ) received both treatments , and 125 ( group 4 ) received only saline .
RESULTS	Groups were similar with respect to age , gender , weight , pre-existing renal dysfunction , hypertension , medication , and baseline serum creatinine and serum cystatin C , but diabetes mellitus was significantly less prevalent in group 1 .
RESULTS	CI-AKI incidence 72 hours after exposure to contrast medium was 51.4 % ( 257/500 ) , measured as serum creatinine > ( baseline +0.3 mg/dL ) and/or serum cystatin C > ( 1.1 baseline ) , and 7.6 % ( 38/500 ) , measured as both serum creatinine and serum cystatin C > ( baseline +0.3 mg/dL ) or > ( 1.25 baseline ) .
RESULTS	CI-AKI incidence measured less sensitively was similar among groups .
RESULTS	Measured more sensitively , incidence in group 1 was significantly ( p < 0.05 ) lower than in groups 2 and 3 but not group 4 ; adjustment for confounding by infused volume equalized incidence in groups 1 and 3 .
CONCLUSIONS	We found no evidence that intravenous isotonic saline and either NaHCO3 or else a high dose of NAC prevent CI-AKI in outpatients exposed to high osmolal iodinated contrast medium more than does saline alone .
BACKGROUND	ClinicalTrials.gov NCT01612013 .

###24261013
OBJECTIVE	The purpose of this study was to examine the relative effectiveness of 2 forms of physical education instruction on students ' skill and technical performance , as well as content knowledge in 3 track and field events .
METHODS	Students from 6 classes in 3 Portuguese schools completed 900-min units conducted under the auspices of sport education or a more traditional teacher-directed format .
METHODS	Classes were randomly assigned to these conditions within each school .
RESULTS	Although both groups improved significantly from pretest to posttest , the sport education classes outperformed the traditional classes in both technique and skill execution .
RESULTS	Only the sport education group made significant improvements in content knowledge .
RESULTS	When the students in the traditional group were tested at the point in time where they would usually complete a unit of physical education ( 450 min ) , there were no significant improvements in any of the study 's variables .
CONCLUSIONS	The explanation given for the superior performance outcomes of the sport education classes lies in the nature of formal competition and team affiliation , which are cornerstones of this pedagogical model .
CONCLUSIONS	That is , students take their learning experiences more seriously than in traditional and often inauthentic classes .
CONCLUSIONS	In terms of content knowledge , the fact that sport education has a level of content-embedded accountability that holds students accountable for their officiating duties is postulated as a significant contributor to their increased understanding of rules and protocols of athletic events .

###24678280
BACKGROUND	Obesity is a disorder often accompanied by a heightened state of systemic inflammation and immunoactivation .
BACKGROUND	The present randomized crossover trial aimed to investigate the efficacy of curcumin , a bioactive polyphenol with established anti-inflammatory and immunomodulatory effects , on the serum levels of a panel of cytokines and mediators in obese individuals .
METHODS	Thirty obese individuals were randomized to receive curcumin at a daily dose of 1 g or a matched placebo for 4 weeks .
METHODS	Following a 2-week wash-out period , each group was assigned to the alternate treatment regimen for another 4 weeks .
METHODS	Serum samples were collected at the start and end of each study period .
METHODS	Serum levels of IL-1 , IL-1 , IL-2 , IL-4 , IL-6 , IL-8 , IL-10 , VEGF , IFN , EGF , MCP-1 , and TNF were measured using a multiplex Biochip Array Technology based method .
RESULTS	Mean serum IL-1 ( P = 0.042 ) , IL-4 ( P = 0.008 ) , and VEGF ( P = 0.01 ) were found to be significantly reduced by curcumin therapy .
RESULTS	In contrast , no significant difference was observed in the concentrations of IL-2 , IL-6 , IL-8 , IL-10 , IFN , EGF , and MCP-1 .
CONCLUSIONS	The findings of the present trial suggested that curcumin may exert immunomodulatory effects via altering the circulating concentrations of IL-1 , IL-4 , and VEGF .

###24859954
OBJECTIVE	To explore the feasibility of subserosal injection of carbon nanoparticle via venous infusion needle to label lymph node and its application value in laparoscopic radical gastrectomy .
METHODS	Forty patients with gastric cancer were randomly divided into two groups ( carbon nanoparticle group and control group ) .
METHODS	Subserosal injection of carbon nanoparticle around the tumor was performed via venous infusion needle laparoscopically at the beginning of surgery in carbon nanoparticles group , while the patients routinely underwent laparoscopic radical gastrectomy in control group .
METHODS	Results of harvested lymph nodes were compared between the two groups .
METHODS	The perioperative complications and the side effect of carbon nanoparticle were also evaluated .
RESULTS	The average number of harvested lymph node in carbon nanoparticle group ( 31.77.6 ) was significantly higher than that in control group ( 19.86.1 , P < 0.05 ) .
RESULTS	The proportion of harvested small node ( < 5 mm ) in carbon nanoparticles group ( 61.0 % ) was higher than that in control group ( 43.3 % , P < 0.01 ) .
RESULTS	The mean harvest time in carbon nanoparticle group [ ( 23.54.8 ) min ] was shorter than that in control group [ ( 32.65.5 ) min , P < 0.05 ] .
RESULTS	The rate of black-dyed harvested lymph node was 61.9 % and the metastasis rate of black-dyed lymph node was 23.0 % in carbon nanoparticle group , which were significantly higher than those without black-dyed ( 6.2 % , P < 0.05 ) and those in control group ( 15.7 % , P < 0.05 ) .
RESULTS	The operative time and perioperative complications were not significantly different between the two groups , and no serious side effect caused by carbon nanoparticle was observed .
CONCLUSIONS	Subserosal injection of carbon nanoparticle via venous infusion needle to label lymph nodes during laparoscopic radical gastrectomy is safe and feasible .
CONCLUSIONS	It can increase the number of harvested lymph node , especially the small node .

###25688779
OBJECTIVE	In patients with severe community-acquired pneumonia , treatment failure is associated with excessive inflammatory response and worse outcomes .
OBJECTIVE	Corticosteroids may modulate cytokine release in these patients , but the benefit of this adjunctive therapy remains controversial .
OBJECTIVE	To assess the effect of corticosteroids in patients with severe community-acquired pneumonia and high associated inflammatory response .
METHODS	Multicenter , randomized , double-blind , placebo-controlled trial conducted in 3 Spanish teaching hospitals involving patients with both severe community-acquired pneumonia and a high inflammatory response , which was defined as a level of C-reactive protein greater than 150 mg/L at admission .
METHODS	Patients were recruited and followed up from June 2004 through February 2012 .
METHODS	Patients were randomized to receive either an intravenous bolus of 0.5 mg/kg per 12 hours of methylprednisolone ( n = 61 ) or placebo ( n = 59 ) for 5 days started within 36 hours of hospital admission .
METHODS	The primary outcome was treatment failure ( composite outcome of early treatment failure defined as [ 1 ] clinical deterioration indicated by development of shock , [ 2 ] need for invasive mechanical ventilation not present at baseline , or [ 3 ] death within 72 hours of treatment ; or composite outcome of late treatment failure defined as [ 1 ] radiographic progression , [ 2 ] persistence of severe respiratory failure , [ 3 ] development of shock , [ 4 ] need for invasive mechanical ventilation not present at baseline , or [ 5 ] death between 72 hours and 120 hours after treatment initiation ; or both early and late treatment failure ) .
METHODS	In-hospital mortality was a secondary outcome and adverse events were assessed .
RESULTS	There was less treatment failure among patients from the methylprednisolone group ( 8 patients [ 13 % ] ) compared with the placebo group ( 18 patients [ 31 % ] ) ( P = .02 ) , with a difference between groups of 18 % ( 95 % CI , 3 % to 32 % ) .
RESULTS	Corticosteroid treatment reduced the risk of treatment failure ( odds ratio , 0.34 [ 95 % CI , 0.14 to 0.87 ] ; P = .02 ) .
RESULTS	In-hospital mortality did not differ between the 2 groups ( 6 patients [ 10 % ] in the methylprednisolone group vs 9 patients [ 15 % ] in the placebo group ; P = .37 ) ; the difference between groups was 5 % ( 95 % CI , -6 % to 17 % ) .
RESULTS	Hyperglycemia occurred in 11 patients ( 18 % ) in the methylprednisolone group and in 7 patients ( 12 % ) in the placebo group ( P = .34 ) .
CONCLUSIONS	Among patients with severe community-acquired pneumonia and high initial inflammatory response , the acute use of methylprednisolone compared with placebo decreased treatment failure .
CONCLUSIONS	If replicated , these findings would support the use of corticosteroids as adjunctive treatment in this clinical population .
BACKGROUND	clinicaltrials.gov Identifier : NCT00908713 .

###25439417
OBJECTIVE	To investigate whether melatonin administered intraoperatively reduced pain following laparoscopic cholecystectomy .
METHODS	Randomized , placebo-controlled , double-blinded study .
METHODS	Two surgical departments in Copenhagen .
METHODS	44 women between 18 and 70 years of age , who were surgical candidates for laparoscopic cholecystectomy .
METHODS	Patients were anesthetized by a standard protocol and received a standard multimodal postoperative analgesic regimen .
METHODS	Patients undergoing surgery were admitted on the day of surgery and were discharged the day after surgery .
METHODS	Ten mg of intravenous ( IV ) melatonin or placebo were administered at the time of surgical incision .
METHODS	Pain was assessed by a set of questionnaires documenting `` pain at rest '' using a visual analog scale ( VAS ) .
METHODS	The use of rescue medication was recorded .
METHODS	Sleep quality and general well-being were measured on separate VAS scales .
METHODS	Sleepiness was assessed by the Karolinska Sleepiness Scale .
RESULTS	Forty-four patients were included and randomized to the study .
RESULTS	Three patients did not complete the study .
RESULTS	No differences in VAS pain scores , sleep quality , general well-being , or sleepiness were found between the two groups in the postoperative period .
RESULTS	The use of postoperative rescue medication did not differ between the groups .
CONCLUSIONS	The use of 10mg of IV melatonin administered during laparoscopic cholecystectomy did not affect postoperative pain or use of analgesic medication .

###24894850
OBJECTIVE	To test the hypothesis that observation with early salvage radiotherapy ( SRT ) is not inferior to ` standard ' treatment with adjuvant RT ( ART ) with respect to biochemical failure in patients with pT3 disease and/or positive surgical margins ( SMs ) after radical prostatectomy ( RP ) .
OBJECTIVE	To compare the following secondary endpoints between the two arms : patient-reported outcomes , adverse events , biochemical failure-free survival , overall survival , disease-specific survival , time to distant failure , time to local failure , cost utility analysis , quality adjusted life years and time to androgen deprivation .
METHODS	The Radiotherapy - Adjuvant Versus Early Salvage ( RAVES ) trial is a phase III multicentre randomised controlled trial led by the Trans Tasman Radiation Oncology Group ( TROG ) , in collaboration with the Urological Society of Australia and New Zealand ( USANZ ) , and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group ( ANZUP ) .
METHODS	In all , 470 patients are planned to be randomised 1:1 to either ART commenced at 4 months of RP ( standard of care ) or close observation with early SRT triggered by a PSA level of > 0.20 ng/mL ( experimental arm ) .
METHODS	Eligible patients have had a RP for adenocarcinoma of the prostate with at least one of the following risk factors : positive SMs extraprostatic extension seminal vesicle involvement .
METHODS	The postoperative PSA level must be 0.10 ng/mL .
METHODS	Rigorous investigator credentialing and a quality assurance programme are designed to promote consistent RT delivery among patients .
RESULTS	Trial is currently underway , with 258 patients randomised as of 31 October 2013 .
RESULTS	International collaborations have developed , including a planned meta-analysis to be undertaken with the UK Medical Research Council/National Cancer Institute of Canada Clinical Trials Group RADICALS ( Radiotherapy and Androgen Deprivation In Combination with Local Surgery ) trial and an innovative psycho-oncology sub-study to investigate a patient decision aid resource .
CONCLUSIONS	On the current evidence available , it remains unclear if ART is equivalent or superior to observation with early SRT .

###24934986
BACKGROUND	Brucellosis remains the most common zoonotic disease throughout the world and especially in Iran .
BACKGROUND	Several clinical trials have tested different therapeutic regimens for brucellosis , but few have assessed the optimal duration of treatment .
METHODS	We performed a randomized controlled trial to compare a triple-drug regimen of doxycycline plus rifampicin for 6 weeks and streptomycin for the first 7 days with doxycycline plus rifampicin for 8 weeks and streptomycin for 7 days in patients with uncomplicated brucellosis in Arak , Iran .
METHODS	The primary outcome measure for the treatment groups was the relapse rate measured at 1 , 3 , 6 , 12 , and 24 months after cessation of therapy .
RESULTS	Eligible patients were randomized to one of the 2 groups with 72 per arm .
RESULTS	We found no significant difference in the relapse rate for the 8-week treatment group compared to the 6-week group ( 9.7 % vs 13.9 % ) .
RESULTS	There were no significant differences between the 6-week and 8-week groups regarding the relapse rate , period between clinical presentation and beginning of treatment , and time of relapse .
RESULTS	Symptom resolution was achieved in all cases at a median 9.5 days and no cases experienced continuing symptoms after treatment .
CONCLUSIONS	Our trial found no significant difference between 6-week and 8-week regimens of doxycycline and rifampicin plus streptomycin for the first 7 days .
CONCLUSIONS	Further comparative studies with a large sample size should be implemented to achieve a consistent therapeutic regimen for uncomplicated brucellosis , to help identify those who may benefit from longer treatment , and to minimize adverse effects and unnecessary continuation of treatment .

###25251736
OBJECTIVE	The purpose of this randomized controlled trial was to evaluate the efficacy of the Dynamic SpineCor brace for early idiopathic scoliosis ( 15-30 ) compared to the natural evolution of the disease .
OBJECTIVE	68 patients participated in this study ( 32 treated and 36 controls ) with at least 5 years follow-up .
METHODS	The inclusion criteria were : 1 ) high risk of evolution : family history and/or proven progressive ; 2 ) no significant pathological malformation of the spine ; 3 ) initial Cobb angle between 15 and 30 ; 4 ) risser 0 , 1 or 2 .
METHODS	Assessment of brace efficacy included the percentage of patients who have 5 or less curve progression and the percentage of patients who have 6 or more progression at skeletal maturity .
RESULTS	At five-year follow-up a correction was achieved in 50 % of treated patient and only in 9.5 % of controls , stabilization in 42.3 % treated and 47.7 % in controls and progression in 26.9 % for the treated group and 42.8 % for controls .
RESULTS	For the control patients we considered as a failure if the Cobb angle worsened by more then 5 from the original angle and the patient then received treatment .
CONCLUSIONS	The results 5 years after the treatment suggested that the SpineCor brace reduced the probability of the progression of early idiopathic scoliosis comparing with its natural history .
CONCLUSIONS	Moreover , the positive outcome appears to be maintained in the long term .

###24767620
BACKGROUND	The hypothalamic-pituitary-adrenal ( HPA ) axis is a critical mediator linking stress to health .
BACKGROUND	Understanding how to modulate its reactivity could potentially help reduce the detrimental health effects of HPA axis activation .
BACKGROUND	Social evaluative threat is a potent activator of this system .
BACKGROUND	Access to control and coping responses can reduce its reactivity to pharmacological activation .
BACKGROUND	Compassionate or affiliative behaviors may also moderate stress reactivity .
BACKGROUND	Impact of these moderators on social evaluative threat is unknown .
BACKGROUND	Here , we tested the hypotheses that interventions to increase control , coping , or compassionate ( versus competitive ) goals could reduce HPA-axis response to social evaluative threat .
METHODS	Healthy participants ( n = 54 ) were exposed to social evaluative threat using the Trier Social Stress Test ( TSST ) .
METHODS	They were randomly assigned to receive one of four different instructions prior to the stressor : Standard TSST instructions ( SI ) , standard instructions with access to `` control '' ( SI Control ) , or one of two cognitive interventions ( CI ) that ( 1 ) increased familiarity and helped participants prepare coping strategies ( CI Coping ) , or ( 2 ) shifted goal orientation from self-promotion to helping others ( CI Compassionate Goals ) .
METHODS	ACTH and cortisol were obtained before and after stress exposure via intravenous catheter .
RESULTS	Control alone had no effect .
RESULTS	CI Compassionate Goals significantly reduced ACTH and cortisol responses to the TSST ; CI Coping raised baseline levels .
RESULTS	Compassionate Goals reduced hormonal responses without reducing subjective anxiety , stress or fear , while increasing expression of pro-social intentions and focus on helping others .
CONCLUSIONS	Brief intervention to shift focus from competitive self-promotion to a goal orientation of helping-others can reduce HPA-axis activation to a potent psychosocial stressor .
CONCLUSIONS	This supports the potential for developing brief interventions as inoculation tools to reduce the impact of predictable stressors and lends support to growing evidence that compassion and altruistic goals can moderate the effects of stress .

###24437955
OBJECTIVE	The aim of the study was to establish the efficacy of anti VEGF ( Vascular Endothelial Growing Factor ) drugs in the treatment of wet form ARMD ( Age-Related Macular Degeneration ) in everyday clinical practice in the Department of Ophthalmology , Faculty Hospital , Hradec Krlov , Czech Republic , E.U. , in patients registered in the Czech national registry AMADEUS .
METHODS	Retrospective study with 24 months follow-up period .
METHODS	In the group were evaluated 143 eyes of 140 patients , out of them were 77 women ( 65.8 % ) , of average age 73.09 ( 71.69 - 74.48 ) years , and 40 men ( 34.2 % ) of average age 74 ( 58 - 85 ) years .
METHODS	All of the patients were completely examined before the beginning of the treatment ; during the treatment were , except the standardized eye examination , in patients treated with ranibizumab the color fundus photography and Optical Coherence Tomography ( OCT ) with measuring of the central retinal thickness performed every three months at least .
METHODS	The patients treated by pegaptanib were examined every six weeks before the drug application .
METHODS	The fluorescence angiography ( FA ) was performed at the beginning of the treatment to establish the type and extension of the choroidal neovascularization and during the treatment in case of necessity to establish the activity of the choroidal neovascular membrane ( CNV ) .
METHODS	The treatment by ranibizumab was in the regimen PRN ( pro re nata ) , and pegaptanib was applied every six months during the first year with the follow-up evaluation of the findings .
METHODS	The treatment evaluations were performed at 12 and 24 months .
RESULTS	During the two years follow - up period , the authors noticed in patients treated with ranibizumab loss of 5.12 letters of ETDRS optotypes in case of mostly classical CNV , in occult CNV loss of 5.45 letters , and in minimally classical CNV loss of 2.83 letters .
RESULTS	In three evaluated eyes with classical CNV in patients treated with pegaptanib we noticed after 2 years loss of 6.67 letters , in eleven eyes with occult CNV we established loss of 9.91 letters , and in two eyes with minimally classical CNV the average best-corrected visual acuity ( BCVA ) remained unchanged .
RESULTS	The pegaptanib treatment results may be influenced by small number of evaluated patients .
RESULTS	The visual acuity changes during the two years treatment were not statistically significant .
RESULTS	We noticed the decrease of average CRT ( central retinal thickness ) in all types of CNV treated both with ranibizumab and pegaptanib after the two years follow up .
RESULTS	To reach these results , an average of 5.51 applications of ranibizumab and 9 applications of pegaptanib during the two years were used .
CONCLUSIONS	In the followed-up group we found , comparing to the natural course of neovascular form of ARMD , retarding of the BCVA decrease during the two years treatment with VEGF inhibitors in everyday clinical practice .
CONCLUSIONS	Better results were achieved with ranibizumab treatment , however the differences were not statistically significant .
CONCLUSIONS	Key words : age related macular degeneration , AMADEUS Czech national registry , ranibizumab , pegaptanib .

###25456960
BACKGROUND	Acupuncture is a safe and well-tolerated treatment for pain relief .
BACKGROUND	Previous studies supported the effectiveness of several acupuncture techniques for postoperative pain .
BACKGROUND	The aim of this randomized , controlled trial was to evaluate the efficacy of acupuncture in reducing pain after thyroid surgery .
METHODS	We randomized 121 patients to a control group ( undergoing only standard postoperative analgesic treatment with acetaminophen ) and an acupuncture group , undergoing also either electroacupuncture ( EA ) or traditional acupuncture ( TA ) .
METHODS	Pain was measured according to intraoperative remifentanil use , acetaminophen daily intake , Numeric Rating Scale ( NRS ) , and McGill Pain Questionnaire on postoperative days ( POD ) 1-3 .
RESULTS	Acupuncture group required less acetaminophen than controls at POD 2 ( P = .01 ) and 3 ( P = .016 ) .
RESULTS	EA patients required less remifentanil ( P = .032 ) and acetaminophen than controls at POD 2 ( P = .004 ) and 3 ( P = .008 ) .
RESULTS	EA patients showed a trend toward better NRS and McGill scores from POD 1 to 3 compared with controls .
RESULTS	EA patients had a lower remifentanil requirement and better NRS and McGill scores than TA patients .
RESULTS	No differences occurred between TA patients and controls .
CONCLUSIONS	Acupuncture may be effective in reducing pain after thyroid surgery .
CONCLUSIONS	EA is more useful ; TA achieves no significant effects .

###25315237
BACKGROUND	Overweight and obesity is a significant health concern during pregnancy .
BACKGROUND	Our aim was to investigate the effect of providing antenatal dietary and lifestyle advice to women who are overweight or obese on components of maternal diet and physical activity .
METHODS	We conducted a randomised controlled trial , in which pregnant women with a body mass index25 kg/m2 , and singleton gestation between 10 ( +0 ) to 20 ( +0 ) weeks were recruited and randomised to Lifestyle Advice ( involving a comprehensive dietary and lifestyle intervention over their pregnancy ) or Standard Care .
METHODS	Within the intervention group , we conducted a nested randomised trial in which a subgroup of women were further randomised to receive access to supervised group walking sessions in addition to the standard information presented during the intervention contacts ( the Walking group ) or standard information only .
METHODS	The outcome measures were maternal dietary intake , ( including food groups , macronutrient and micronutrient intake , diet quality ( using the Healthy Eating Index ; HEI ) , dietary glycaemic load , and glycaemic index ) and maternal physical activity .
METHODS	Women completed the Harvard Semi-Structured Food Frequency Questionnaire , and the Short Questionnaire to Assess Health-enhancing Physical Activity ( SQUASH ) , at trial entry , 28 and 36 weeks ' gestational age , and 4 months postpartum .
METHODS	Analyses were performed on an intention-to-treat basis , using linear mixed effects models with adjustment for the stratification variables .
RESULTS	Women randomised to Lifestyle Advice demonstrated a statistically significant increase in the number of servings of fruit and vegetables consumed per day , as well as increased consumption of fibre , and reduced percentage energy intake from saturated fats ( P < 0.05 for all ) .
RESULTS	Maternal HEI was significantly improved at both 28 ( 73.356.62 versus 71.867.01 ; adjusted difference in means 1.58 ; 95 % CI 0.89 to 2.27 ; P < 0.0001 ) and 36 ( 72.956.82 versus 71.177.69 ; adjusted difference in means 1.77 ; 95 % CI 1.01 to 2.53 ; P < 0.0001 ) weeks .
RESULTS	There were no differences in dietary glycaemic index or glycaemic load .
RESULTS	Women randomised to Lifestyle Advice also demonstrated greater total physical activity ( adjusted difference in means 359.76 metabolic equivalent task units ( MET ) minutes/week ; 95 % CI 74.87 to 644.65 ; P = 0.01 ) compared with women receiving Standard Care .
RESULTS	The supervised walking group was poorly utilised .
CONCLUSIONS	For women who are overweight or obese , antenatal lifestyle advice improves maternal diet and physical activity during pregnancy .
CONCLUSIONS	Please see related articles : http://www.biomedcentral.com/1741-7015/12/163 and http://www.biomedcentral.com/1741-7015/12/201 .
BACKGROUND	Australian and New Zealand Clinical Trials Registry ( ACTRN12607000161426 ) .

###25492279
OBJECTIVE	Although there are various therapeutic modalities to manage patients suffering from sacrococcygeal pilonidal sinus disease , there remains controversy over a standard method to treat such patients .
OBJECTIVE	In this study the postoperative outcomes after three different surgical methods of wound repair in patients with sacrococcygeal pilonidal sinus were compared .
METHODS	Patients were divided randomly into three different groups .
METHODS	All of the patients underwent a wide excision of their pilonidal sinus ; the subsequent surgical wound was left open in the first group ( lay open group ) whereas it was repaired with a simple primary closure and a rhomboid flap in the second and third groups .
METHODS	Variables including length of hospitalisation , time for wound healing , time off work , recurrence and surgical complications were evaluated .
RESULTS	A total of 60 patients with an average age of 27.61 years were studied , including 47 ( 78.3 % ) men and 13 ( 21.7 % ) women .
RESULTS	Postoperative hospitalisation time was significantly shorter in patients who were treated using the simple primary closure method than those with the rhomboid flaps .
RESULTS	However , there were no differences in terms of postoperative hospitalisation time between the lay open and simple primary groups or the lay open and rhomboid groups .
RESULTS	The period of absence from work was significantly shorter in patients who were managed by a simple primary closure or rhomboid flap technique comparing to those whose wound was left open ( p < 0.05 ) .
RESULTS	Complete wound healing had a significantly shorter course in the rhomboid flap and the simple primary closure techniques compared to those within the lay open group .
RESULTS	In terms of complications , postoperative infection and haemorrhage were more common in the lay open group than in the other two .
RESULTS	Recurrence was about 5 % in patients who were treated with the lay open method in an 18-month follow-up period ; however , no recurrence was observed in the other two groups .
CONCLUSIONS	Considering the earlier wound healing period , less days absent from work , lower complication levels and recurrence rates , the simple primary closure or rhomboid flap techniques appear to be better options to treat the subsequent wound after a wide excision of pilonidal sinus when compared to the lay open method .
CONCLUSIONS	The simple primary closure method causes no cosmetic disfiguration and the most promising option among the three techniques assessed .
BACKGROUND	The authors have declared that no conflict of interest exists .

###25475465
BACKGROUND	In current literature the association between statin use and cataracts is inconsistent and controversial .
BACKGROUND	We sought to further examine the effect of statin use on the risk of cataract and need for surgical intervention in 2 North American populations .
METHODS	This retrospective nested case-control study derived data from the British Columbia ( BC ) Ministry of Health databases from 2000-2007 and the IMS LifeLink database from 2001-2011 to form 2 patient cohorts .
METHODS	The BC cohort was comprised of female and male patients ; 162,501 patients were matched with 650,004 control subjects .
METHODS	The IMS LifeLink cohort was comprised of male patients aged 40-85 years ; 45,065 patients were matched with 450,650 control subjects .
METHODS	Patients with statin use for > 1 year before the initial ophthalmology visit were identified .
METHODS	Diagnosis and surgical management of cataract were followed .
METHODS	Conditional logistic regression models were used to analyze data .
RESULTS	For the BC cohort , the crude rate ratio ( RR ) for use of any statin was 1.30 , and the adjusted RR was 1.27 ( 95 % confidence interval , 1.24-1 .30 ) .
RESULTS	The adjusted RRs for each individual statin were all statistically significant .
RESULTS	For the IMS LifeLink cohort , the crude RR for use of any statin was 1.13 , and the adjusted RR was 1.07 ( 95 % confidence interval , 1.04-1 .10 ) .
CONCLUSIONS	This study demonstrates that statin use is significantly associated with cataract requiring surgical intervention .
CONCLUSIONS	This relationship was consistent in both North American cohorts .
CONCLUSIONS	Further assessment of this relationship is recommended , especially because of increased statin use and the importance of acceptable vision in old age when cardiovascular disease is common .

###24534405
OBJECTIVE	Dental caries in young children is commonly untreated and represents a public health problem .
OBJECTIVE	Dental caries in children is reported to affect their anthropometric outcomes , but the evidence is conflicting .
OBJECTIVE	Some studies found no association , whereas others found that caries was associated with underweight or overweight .
OBJECTIVE	The objective was to assess the relationship between dental caries status and height and weight in 6 - to 8-year-old Saudi children with high caries prevalence .
METHODS	This study was a cross-sectional survey in schoolchildren aged 6 to 8 years attending military primary schools in Jeddah , Saudi Arabia .
METHODS	Caries status was assessed by using the dmft ( decayed , missing , filled , teeth [ primary teeth ] ) index .
METHODS	Height and weight were assessed by using z scores of height-for-age ( HAZ ) , weight-for-age ( WAZ ) , and BMI-for-age ( BAZ ) calculated by World Health Organization standardized procedures .
METHODS	Relationships between caries and HAZ , WAZ , and BAZ were assessed by using regression models .
RESULTS	A total of 417 of the 436 eligible schoolchildren with complete data were included , with a response rate of 95.6 % .
RESULTS	Their mean dmft index was 5.7 4.2 .
RESULTS	There was an inverse linear relationship between caries status and children 's HAZ , WAZ , and BAZ and significantly lower anthropometric outcomes for children at each consecutive group with higher levels of caries .
RESULTS	The associations remained significant after adjusting for dental , social , and demographic variables .
CONCLUSIONS	The inverse linear association between dental caries and all anthropometric outcomes suggests that higher levels of untreated caries are associated with poorer growth in Saudi schoolchildren .

###24690207
BACKGROUND	Inguinal hernia repair is one of the most common surgical procedures worldwide .
BACKGROUND	This procedure is increasingly performed with endoscopic techniques ( laparoscopy ) .
BACKGROUND	Many surgeons prefer to cover the hernia gap with a mesh to prevent recurrence .
BACKGROUND	The mesh must be fixed tightly , but without tension .
BACKGROUND	During laparoscopic surgery , the mesh is generally fixed with staples or tissue glue .
BACKGROUND	However , staples often cause pain at the staple sites , and they can cause scarring of the abdominal wall , which can lead to chronic pain .
BACKGROUND	We designed a trial that aims to determine whether mesh fixation with glue might cause less postoperative pain than fixation with staples during a transabdominal preperitoneal patch plastic repair .
METHODS	The TISTA trial is a prospective , randomized , controlled , single-center trial with a two-by-two parallel design .
METHODS	All patients and outcome-assessors will be blinded to treatment allocations .
METHODS	For eligibility , patients must be male , 18 years old , and scheduled for laparoscopic repair of a primary inguinal hernia .
METHODS	One group comprises patients with a unilateral inguinal hernia that will be randomized to receive mesh fixation with either tissue glue or staples .
METHODS	The second group comprises patients with bilateral inguinal hernias .
METHODS	They will be randomized to receive mesh fixation with tissue glue either on the right or the left side and with staples on the other side .
METHODS	The primary endpoint will be pain under physical stress , measured at 24 h after surgery .
METHODS	Pain will be rated by the patient based on a numeric rating scale from 0 to 10 , where 10 equals the worst pain imaginable .
METHODS	A total of 82 patients will be recruited ( 58 patients with unilateral inguinal hernias and 24 patients with bilateral hernias ) .
METHODS	This number is estimated to provide 90 % power for detecting a pain reduction of one point on a numeric rating scale , with a standard deviation of one .
CONCLUSIONS	Patients with bilateral hernias will receive two meshes , one fixed with glue , and the other fixed with staples .
CONCLUSIONS	This design will eliminate the inter-individual bias inherent in comparing pain measurements between two groups of patients .
BACKGROUND	ClinicalTrials.gov : NCT01641718 .

###24927291
OBJECTIVE	To examine the impact of providing fertility information on personal levels of fertility knowledge and intentions to delay childbearing .
METHODS	Participants ( n = 69 young childless women ) were randomly assigned to either an experimental ( fertility-related ) or control ( alcohol-related ) informational intervention group .
METHODS	Subsequent to the exposure to information , participants completed a questionnaire measuring fertility knowledge and intentions for reproduction .
METHODS	We predicted that the provision of fertility-related information would result in greater fertility knowledge and less intention to delay childbearing among young childless women .
RESULTS	The young women exposed to the brief fertility information intervention were significantly more likely to respond correctly to questions testing their fertility knowledge , and reported less intention to delay childbearing than the young women in the control group .
CONCLUSIONS	This study provided evidence that providing fertility-related information contributes to greater reproductive knowledge and may affect childbearing intentions .
CONCLUSIONS	Future research is warranted to examine the influence of fertility information on reproductive decision-making within a theoretical framework in order to ensure that subsequent information interventions maximize their effectiveness .

###25418216
BACKGROUND	Operators who extract cardiac devices are exposed to considerable irradiation and excess risk of radiation-induced disorders .
BACKGROUND	A dedicated radioprotection cabin was developed to offer complete protection against radiation .
BACKGROUND	This randomized study was designed to ascertain the protection against radiation conferred by a radioprotection cabin and the safety during extraction of cardiac devices .
METHODS	Thirty-seven consecutive patients who presented with an indication for extraction of a cardiac device were randomly assigned to a standard extraction technique ( n = 19 ) , vs extraction with the use of a radiation protection cabin ( n = 18 ) .
METHODS	Fluoroscopic exposure was compared using electronic dosimeters placed on the thorax , back , foot , and head of the operator .
RESULTS	The procedural times and total fluoroscopic exposure times and the complication rates were not significantly different between the 2 groups .
RESULTS	The mean dose of radiation delivered to the thorax and back was similar in both groups ( P = 0.3 and P = 0.8 , respectively ) .
RESULTS	In contrast , the mean doses of radiation delivered to the head and to the feet were respectively 68 and 390 times less in the cabin group than in the control group ( P < 0.001 ) .
CONCLUSIONS	The cabin offers nearly full body radioprotection and eliminates the need to wear a lead apron , without increasing procedural time or complication rate during cardiac device extraction .

###24965551
BACKGROUND	Previous research on the effects of plain packaging has largely relied on self-report measures .
BACKGROUND	Here we describe the protocol of a randomized controlled trial investigating the effect of the plain packaging of cigarettes on smoking behavior in a real-world setting .
METHODS	In a parallel group randomization design , 128 daily cigarette smokers ( 50 % male , 50 % female ) will attend an initial screening session and be assigned plain or branded packs of cigarettes to smoke for a full day .
METHODS	Plain packs will be those currently used in Australia where plain packaging has been introduced , while branded packs will be those currently used in the United Kingdom .
METHODS	Our primary study outcomes will be smoking behavior ( self-reported number of cigarettes smoked and volume of smoke inhaled per cigarette as measured using a smoking topography device ) .
METHODS	Secondary outcomes measured pre - and post-intervention will be smoking urges , motivation to quit smoking , and perceived taste of the cigarettes .
METHODS	Secondary outcomes measured post-intervention only will be experience of smoking from the cigarette pack , overall experience of smoking , attributes of the cigarette pack , perceptions of the on-packet health warnings , behavior changes , views on plain packaging , and the rewarding value of smoking .
METHODS	Sex differences will be explored for all analyses .
CONCLUSIONS	This study is novel in its approach to assessing the impact of plain packaging on actual smoking behavior .
CONCLUSIONS	This research will help inform policymakers about the effectiveness of plain packaging as a tobacco control measure .
BACKGROUND	Current Controlled Trials ISRCTN52982308 ( registered 27 June 2013 ) .

###24228630
BACKGROUND	In European countries , including Switzerland , as well as in many states worldwide , cannabis is the most widely used psychoactive substance after alcohol and tobacco .
BACKGROUND	Although approximately one in ten users develop serious problems of dependency , only a minority attends outpatient addiction counseling centers .
BACKGROUND	The offer of a combined web-based self-help and chat counseling treatment could potentially also reach those users who hesitate to approach such treatment centers and help them to reduce their cannabis use .
METHODS	This paper presents the protocol for a three-armed randomized controlled trial that will test the effectiveness of a web-based self-help intervention in combination with , or independent of , tailored chat counseling compared to a waiting list in reducing or enabling the abstention from cannabis use in problematic users .
METHODS	The primary outcome will be the weekly quantity of cannabis used .
METHODS	Secondary outcome measures will include the number of days per week on which cannabis is used , the severity of cannabis use disorder , the severity of cannabis dependence , cannabis withdrawal symptoms , cannabis craving , the use of alcohol , tobacco , and other non-cannabis illicit drugs , changes in mental health symptoms , and treatment retention .
METHODS	The self-help intervention will consist of 8 modules designed to reduce cannabis use based on the principles of motivational interviewing , self-control practices , and methods of cognitive behavioral therapy .
METHODS	The two additional individual chat-counseling sessions in the additional chat condition will be based on the same therapy approaches and tailored to participants ' self-help information data and personal problems .
METHODS	The predictive validity of participants ' baseline characteristics on treatment retention and outcomes will be explored .
CONCLUSIONS	To the best of our knowledge , this will be the first randomized controlled trial to test the effectiveness of online self-help therapy in combination or without chat counseling in reducing or enabling the abstention from cannabis use .
CONCLUSIONS	It will also investigate predictors of outcome and retention for these interventions .
CONCLUSIONS	This trial is registered at Current Controlled Trials and is traceable as ISRCTN59948178 .

###25092278
BACKGROUND	Hypertrophic cardiomyopathy ( HCM ) is the most common cause of sudden death in the young , although not all patients eligible for sudden death prevention with an implantable cardioverter-defibrillator are identified .
BACKGROUND	Contrast-enhanced cardiovascular magnetic resonance with late gadolinium enhancement ( LGE ) has emerged as an in vivo marker of myocardial fibrosis , although its role in stratifying sudden death risk in subgroups of HCM patients remains incompletely understood .
RESULTS	We assessed the relation between LGE and cardiovascular outcomes in 1293 HCM patients referred for cardiovascular magnetic resonance and followed up for a median of 3.3 years .
RESULTS	Sudden cardiac death ( SCD ) events ( including appropriate defibrillator interventions ) occurred in 37 patients ( 3 % ) .
RESULTS	A continuous relationship was evident between LGE by percent left ventricular mass and SCD event risk in HCM patients ( P = 0.001 ) .
RESULTS	Extent of LGE was associated with an increased risk of SCD events ( adjusted hazard ratio , 1.46 / 10 % increase in LGE ; P = 0.002 ) , even after adjustment for other relevant disease variables .
RESULTS	LGE of 15 % of LV mass demonstrated a 2-fold increase in SCD event risk in those patients otherwise considered to be at lower risk , with an estimated likelihood for SCD events of 6 % at 5 years .
RESULTS	Performance of the SCD event risk model was enhanced by LGE ( net reclassification index , 12.9 % ; 95 % confidence interval , 0.3-38 .3 ) .
RESULTS	Absence of LGE was associated with lower risk for SCD events ( adjusted hazard ratio , 0.39 ; P = 0.02 ) .
RESULTS	Extent of LGE also predicted the development of end-stage HCM with systolic dysfunction ( adjusted hazard ratio , 1.80 / 10 % increase in LGE ; P < 0.03 ) .
CONCLUSIONS	Extensive LGE measured by quantitative contrast enhanced CMR provides additional information for assessing SCD event risk among HCM patients , particularly patients otherwise judged to be at low risk .

###24560179
OBJECTIVE	To determine whether umbilical cord milking ( UCM ) improves systemic blood flow and reduces neonatal morbidities compared with immediate cord clamping ( ICC ) .
METHODS	Women admitted to a tertiary care center and delivering before 32 weeks ' gestation were randomized to receive UCM or ICC .
METHODS	Three blinded serial echocardiograms were performed in the first 2 days of the infant 's life .
METHODS	The primary outcome was measured systemic blood flow ( superior vena cava flow ) at each time point .
RESULTS	Of the 60 neonates who were enrolled and randomized , 30 were assigned to cord milking and 30 to ICC .
RESULTS	Neonates randomized to cord milking had greater measures of superior vena cava flow and right ventricular output in the first 6 hours and 30 hours of life .
RESULTS	Neonates receiving UCM also had greater serum hemoglobin , received fewer blood transfusions , fewer days on oxygen therapy , and less frequent use of oxygen at 36 weeks ' corrected postmenstrual age .
CONCLUSIONS	We demonstrate greater systemic blood flow with UCM in preterm neonates compared with ICC .
CONCLUSIONS	Future large prospective trials are needed to determine whether UCM reduces intraventricular hemorrhage and other long-term morbidities .

###25111438
BACKGROUND	The use of ablative lasers based on the fractional approach is a novel strategy for the treatment of postoperative and acne scars in addition to wrinkles .
OBJECTIVE	To evaluate and compare the efficacy of carbon dioxide ablative fractional laser ( AFL ) and the pulsed dye laser ( PDL ) for the improvement of surgical scars .
METHODS	Fourteen Korean patients with surgical scars were enrolled for this study .
METHODS	Half of each scar was treated with a 10,600-nm AFL and the contralateral half with the 595-nm PDL .
METHODS	For early intervention of the postoperative scar , the laser treatments were begun after 2 weeks from the Mohs micrographic surgery .
RESULTS	Both PDL and AFL produced statistically significant improvements .
RESULTS	However , comparatively , there was no statistical difference between them .
RESULTS	In each variable , AFL was more effective than PDL in the improvement of pliability and thickness .
RESULTS	In contrast , PDL was superior to AFL in the improvement of vascularity and pigmentation .
CONCLUSIONS	Pulsed dye laser and AFL treatments for surgical scar provide significant improvement .
CONCLUSIONS	Pulsed dye laser was more effective in color of scar compared with AFL , which showed marked improvement in the contour of scar .
CONCLUSIONS	Overall improvement was not statistically different in the Vancouver Scar Scale .

###24461666
BACKGROUND	Ivacaftor has shown a clinical benefit in patients with cystic fibrosis who have the G551D-CFTR mutation and reduced lung function .
BACKGROUND	Lung clearance index ( LCI ) using multiple-breath washout might be an alternative to and more sensitive method than forced expiratory volume in 1 s ( FEV1 ) to assess treatment response in the growing number of children and young adults with cystic fibrosis who have normal spirometry .
BACKGROUND	The aim of the study was to assess the treatment effects of ivacaftor on LCI in patients with cystic fibrosis , a G551D-CFTR mutation , and an FEV1 > 90 % predicted .
METHODS	This phase 2 , multicentre , placebo-controlled , double-blind 22 crossover study of ivacaftor treatment was conducted in patients with cystic fibrosis , at least one G551D-CFTR allele , and an FEV1 > 90 % predicted .
METHODS	Patients also had to have an LCI higher than 74 at screening , age of 6 years or older , and a weight higher than or equal to 15 kg .
METHODS	Eligible patients were randomly allocated to receive one of two treatment sequences ( placebo first followed by ivacaftor 150 mg twice daily [ sequence 1 ] or ivacaftor 150 mg twice daily first followed by placebo [ sequence 2 ] ) of 28 days ' treatment in each period , with a 28-day washout between the two treatment periods .
METHODS	Randomisation ( ratio 1:1 ) was done with block sizes of 4 , and all site personnel including the investigator , the study monitor , and the Vertex study team were masked to treatment assignment .
METHODS	The primary outcome measure was change from baseline in LCI .
METHODS	The study is registered at ClinicalTrials.gov , NCT01262352 .
RESULTS	Between February and November , 2011 , 21 patients were enrolled , of which 11 were assigned to the sequence 1 group , and 10 to the sequence 2 group .
RESULTS	20 of these patients received treatment and 17 completed the trial ( eight in sequence 1 group and 9 in sequence 2 group ) .
RESULTS	Treatment with ivacaftor led to significant improvements compared with placebo in LCI ( difference between groups in the average of mean changes from baseline at days 15 and 29 was -216 [ 95 % CI -288 to -144 ] ; p < 00001 ) .
RESULTS	Adverse events experienced by study participants were similar between treatment groups ; at least one adverse event was reported by 15 ( 79 % ) of 19 patients who received placebo and 13 ( 72 % ) of 18 patients who received ivacaftor .
RESULTS	No deaths occurred during study period .
CONCLUSIONS	In patients with cystic fibrosis aged 6 years or older who have at least one G551D-CFTR allele , ivacaftor led to improvements in LCI .
CONCLUSIONS	LCI might be a more sensitive alternative to FEV1 in detecting response to intervention in these patients with mild lung disease .
BACKGROUND	Vertex Pharmaceuticals Incorporated .

###24369785
BACKGROUND	In elderly persons frailty and malnutrition are very common and can lead to serious health hazards such as increased mortality , morbidity , dependency , institutionalization and a reduced quality of life .
BACKGROUND	In Austria , the prevalence of frailty and malnutrition are increasing steadily and are becoming a challenge for our social system .
BACKGROUND	Physical training and adequate nutrition may improve this situation .
METHODS	In this randomized controlled trial , 80 malnourished frail community-dwelling patients ( 65 years ) hospitalized at wards for internal medicine are recruited .
METHODS	Additionally , 80 lay volunteers ( 50 years ) , named buddies are recruited and subsequently trained regarding health enhancing physical activity and nutrition in four standardized training sessions .
METHODS	These buddies visit the malnourished frail persons at home twice a week for about one hour during an initial period of 10-12 weeks .
METHODS	While participants allocated to the intervention group ( n = 40 ) receive intervention to improve their fluid intake , protein and energy intake , perform strength training and try to increase their baseline activities , the control group ( n = 40 ) only gets home visits without any intervention .
METHODS	After 10-12 weeks , both , the intervention and the control group , receive the nutritional intervention and the physical training .
METHODS	Health , nutritional and frailty status , physical fitness , body composition and chronic inflammation of buddies and frail persons are recorded before the intervention , after 10-12 weeks , 6 and 12 months .
CONCLUSIONS	To your knowledge this trial is the first of its kind to provide nutritional and physical activity interventions to malnourished frail community-dwelling persons by trained lay buddies , in which an improvement of the frail persons ' and the buddies ' health status is measured .
CONCLUSIONS	This study assesses the efficacy of such an intervention and may offer new perspectives for the management of frailty and malnutrition .
BACKGROUND	[ corrected ] ClinicalTrials.gov , NCT01991639 .

###25126867
OBJECTIVE	Hypertension remains a significant risk factor in cardiovascular morbidity and mortality .
OBJECTIVE	The purpose of the present study was to investigate the effects of 8 weeks interval training programme on blood pressure , aerobic capacity ( VO max ) , indices of adiposity and marker of inflammation in black African men with essential hypertension .
METHODS	Two hundred and forty five ( 245 ) male subjects with stage 1 and 2 ( systolic blood pressure [ SBP ] between 140-179 & diastolic blood pressure [ DBP ] between 90-109 mmHg ) essential hypertension were age matched and grouped into experimental and control groups .
METHODS	The experimental ( n = 140 ; 58.90 7.35 years ) group involved in an 8 weeks interval training ( 60-79 % HRmax ) programme of between 45 and 60 minutes , while age-matched control hypertensive ( n = 105 ; 58.276.24 years ) group remain sedentary during this period .
METHODS	All subjects in both groups were on antihypertensive drugs throughout the study period .
METHODS	Cardiovascular parameters ( SBP , DBP ) & VO max and percent body fat [ % BF ] , waist to hip ratio [ WHR ] and C-reactive protein [ CRP ] were assessed .
METHODS	Independent t-test and Pearson correlation test were used in data analysis .
RESULTS	Findings of the study revealed significant decreased effects of interval training programme on SBP , DBP , % BF , WHR and CRP and significant increased effect on VO max at p < 0.05 .
RESULTS	Also , changes in CRP as a result of exercise training significantly and positively correlated with changes in SBP , DBP , % BF , WHR , CRP and negatively correlated with VO max at p < 0.05 .

###24886235
BACKGROUND	This article provides a description of the rationale , design , and methods of a multisite clinical trial which evaluates the potential benefits of an evidence-based psychosocial treatment , STAIR Narrative Therapy , among women with posttraumatic stress disorder ( PTSD ) related to interpersonal violence who are seeking services in public sector community mental health clinics .
BACKGROUND	This is the first large multisite trial of an evidence-based treatment for PTSD provided in the context of community settings that are dedicated to the treatment of poverty-level patient populations .
METHODS	The study is enrolling 352 participants in a minimum of 4 community clinics .
METHODS	Participants are randomized into either STAIR Narrative Therapy or Treatment As Usual ( TAU ) .
METHODS	Primary outcomes are PTSD , emotion management and interpersonal problems .
METHODS	The study will allow a flexible application of the protocol determined by patient need and preferences .
METHODS	Secondary analyses will assess the relationship of outcomes to different patterns of treatment implementation for different levels of baseline symptom severity .
CONCLUSIONS	The article discusses the rationale and study issues related to the use of a flexible delivery of a protocol treatment and of the selection of treatment as it is actually practiced in the community as the comparator .
BACKGROUND	Clinicaltrials.gov identifier : NCT01488539 .

###25249453
OBJECTIVE	To assess the effect of provision of free glasses on academic performance in rural Chinese children with myopia .
METHODS	Cluster randomized , investigator masked , controlled trial .
METHODS	252 primary schools in two prefectures in western China , 2012-13 .
METHODS	3177 of 19,934 children in fourth and fifth grades ( mean age 10.5 years ) with visual acuity < 6/12 in either eye without glasses correctable to > 6/12 with glasses .
METHODS	3052 ( 96.0 % ) completed the study .
METHODS	Children were randomized by school ( 84 schools per arm ) to one of three interventions at the beginning of the school year : prescription for glasses only ( control group ) , vouchers for free glasses at a local facility , or free glasses provided in class .
METHODS	Spectacle wear at endline examination and end of year score on a specially designed mathematics test , adjusted for baseline score and expressed in standard deviations .
RESULTS	Among 3177 eligible children , 1036 ( 32.6 % ) were randomized to control , 988 ( 31.1 % ) to vouchers , and 1153 ( 36.3 % ) to free glasses in class .
RESULTS	All eligible children would benefit from glasses , but only 15 % wore them at baseline .
RESULTS	At closeout glasses wear was 41 % ( observed ) and 68 % ( self reported ) in the free glasses group , and 26 % ( observed ) and 37 % ( self reported ) in the controls .
RESULTS	Effect on test score was 0.11 SD ( 95 % confidence interval 0.01 to 0.21 ) when the free glasses group was compared with the control group .
RESULTS	The adjusted effect of providing free glasses ( 0.10 , 0.002 to 0.19 ) was greater than parental education ( 0.03 , -0.04 to 0.09 ) or family wealth ( 0.01 , -0.06 to 0.08 ) .
RESULTS	This difference between groups was significant , but was smaller than the prespecified 0.20 SD difference that the study was powered to detect .
CONCLUSIONS	The provision of free glasses to Chinese children with myopia improves children 's performance on mathematics testing to a statistically significant degree , despite imperfect compliance , although the observed difference between groups was smaller than the study was originally designed to detect .
CONCLUSIONS	Myopia is common and rarely corrected in this setting.Trial Registration Current Controlled Trials ISRCTN03252665 .

###24518532
OBJECTIVE	We designed and evaluated for feasibility an intervention-Yo Puedo-that addresses social network influences and socioeconomic opportunities in a neighborhood with substantial gang exposure and early childbearing .
METHODS	Yo Puedo combined conditional cash transfers for completion of educational and reproductive health wellness goals with life skills sessions , and targeted youth 16-21 years of age and same-aged members of their social network .
METHODS	We conducted a two-arm study with social networks randomized to the intervention or a standard services control arm .
METHODS	We evaluated intervention uptake , adherence , and safety ; and assessed evidence of effects on behavioral outcomes associated with unintended pregnancy and sexually transmitted infection risk .
RESULTS	A total of 72 social networks composed of 162 youth enrolled , with 92 % retention over 6 months .
RESULTS	Seventy-two percent of youth randomized to the intervention participated in intervention activities : 53 % received at least one conditional cash transfer payment and 66 % came to at least one life skills session .
RESULTS	We found no evidence that cash payments financed illicit or high-risk behavior .
RESULTS	At 6 months , compared with controls , intervention participants had a lower odds of hanging out on the street frequently ( odds ratio [ OR ] , .54 ; p = .10 ) and a lower odds of reporting that their close friends had been incarcerated ( OR , .6 ; p = .12 ) .
RESULTS	They reported less regular alcohol use ( OR , .54 ; p = .04 ) and a lower odds of having sex ( OR , .50 ; p = .04 ) .
CONCLUSIONS	The feasibility evaluation of Yo Puedo demonstrated its promise ; a larger evaluation of effects on pregnancy and sustained behavioral changes is warranted .

###25047652
OBJECTIVE	To investigate the prognostic value of electrodiagnostic testing in patients with sciatica receiving physical therapy .
METHODS	Electrodiagnostic testing was performed on 38 patients with sciatica participating in a randomized trial comparing different physical therapy interventions .
METHODS	Patients were grouped and analyzed according to the presence or absence of radiculopathy based on electrodiagnostic testing .
METHODS	Longitudinal data analysis was conducted using multilevel growth modeling with ten waves of data collected from baseline through the treatment and post-treatment periods up to 6 months .
METHODS	The primary outcome measure was changes in low back pain-related disability assessed using the Roland and Morris disability questionnaire ( RMDQ ) .
RESULTS	Patients with radiculopathy ( n = 19 ) had statistically significant and clinically meaningful improvements in RMDQ scores at every post-treatment follow-up occasion regardless of treatment received .
RESULTS	The final multilevel growth model revealed improvements in RMDQ scores in patients with radiculopathy at the 6-week ( -8.1 , 95 % CI -12.6 to -2.6 ; P = 0.006 ) and 6-month ( -4.1 , 95 % CI -7.4 to -0.7 ; P = 0.020 ) follow-up occasions compared to patients without radiculopathy .
RESULTS	Treatment group was not a significant predictive factor at any follow-up occasion .
RESULTS	An interaction between electrodiagnostic status and time revealed faster weekly improvements in RMDQ scores in patients with radiculopathy at the 6-week ( -0.72 , 95 % CI -1.4 to -0.04 ; P = 0.040 ) through the 16-week ( -0.30 , 95 % CI , -0.57 to -0.04 ; P = 0.028 ) follow-up occasions compared to patients without radiculopathy .
CONCLUSIONS	The presence of lumbosacral radiculopathy identified with electrodiagnostic testing is a favorable prognostic factor for recovery in low back pain-related disability regardless of physical therapy treatment received .

###25673979
BACKGROUND	Loss of mechanical tension appears to be the major factor underlying decreased collagen synthesis in aged skin .
BACKGROUND	Numerous in vitro studies have shown the impact of mechanical forces on fibroblasts through mechanotransduction , which consists of the conversion of mechanical signals to biochemical responses .
BACKGROUND	Such responses are characterized by the modulation of gene expression coding not only for extracellular matrix components ( collagens , elastin , etc. ) but also for degradation enzymes ( matrix metalloproteinases [ MMPs ] ) and their inhibitors ( tissue inhibitors of metalloproteinases [ TIMPs ] ) .
BACKGROUND	A new device providing a mechanical stimulation of the cutaneous and subcutaneous tissue has been used in a simple , blinded , controlled , and randomized study .
METHODS	Thirty subjects ( aged between 35 years and 50 years ) , with clinical signs of skin sagging , were randomly assigned to have a treatment on hemiface .
METHODS	After a total of 24 sessions with Mcano-Stimulation , biopsies were performed on the treated side and control area for in vitro analysis ( dosage of hyaluronic acid , elastin , type I collagen , MMP9 ; equivalent dermis retraction ; GlaSbox ( ) ; n = 10 ) and electron microscopy ( n = 10 ) .
METHODS	Furthermore , before and after the treatment , clinical evaluations and self-assessment questionnaire were done .
RESULTS	In vitro analysis showed increases in hyaluronic acid , elastin , type I collagen , and MMP9 content along with an improvement of the migratory capacity of the fibroblasts on the treated side .
RESULTS	Electron microscopy evaluations showed a clear dermal remodeling in relation with the activation of fibroblast activity .
RESULTS	A significant improvement of different clinical signs associated with skin aging and the satisfaction of the subjects were observed , correlated with an improvement of the sagging cheek .
CONCLUSIONS	Mcano-Stimulation is a noninvasive and safe technique delivered by flaps microbeats at various frequencies , which can significantly improve the skin trophicity .
CONCLUSIONS	Results observed with objective measurements , ie , in vitro assessments and electron microscopy , confirm the firming and restructuring effect clinically observed .

###24811201
BACKGROUND	A double-blind RCT on the short-term efficacy of nicotine patches compared to placebo patches among Dutch adolescents was conducted .
BACKGROUND	The findings demonstrated that nicotine patches are efficacious for smoking cessation at end-of-treatment ; however , only in highly compliant participants .
BACKGROUND	We tested whether the effects of NRT also held in 6 - ( T7 ) and 12-month ( T8 ) follow-up assessments .
METHODS	Adolescents aged 12-18 years , who smoked at least seven cigarettes a day and who were motivated to quit smoking were recruited at school yards and randomly assigned to either a nicotine patch ( n = 182 ) or a placebo patch ( n = 180 ) condition according to a computer generated list .
METHODS	Participants ( N = 257 , age : 16.7 1.13 years ) attended an information meeting followed by a 6 - or 9-week treatment .
METHODS	Smoking cessation , compliance , and potential covariates were measured by means of online questionnaires .
METHODS	Smoking cessation at T8 was biochemically validated by saliva cotinine .
RESULTS	At T7 , 8.1 % and 5.7 % of participants were abstinent in the nicotine and placebo patch groups , respectively .
RESULTS	At T8 , abstinence was 4.4 % and 6.6 % , respectively .
RESULTS	Intention-to-treat analyses showed no significant effects of NRT on abstinence rates at T7 ( OR = 1.54 , 95 % CI = 0.57 , 4.16 ) and validated abstinence rates at T8 ( OR = 0.64 , 95 % CI = 0.21 , 1.93 ) neither after considering compliance nor after adjusting for covariates .
CONCLUSIONS	NRT fails in helping adolescents quit smoking at 6 - and 12-month follow-ups .
CONCLUSIONS	This finding suggests that a more intensive approach is needed to assist youngsters in their quit attempts .

###25022428
OBJECTIVE	The aim of this exploratory randomised controlled trial ( RCT ) was to evaluate three different occupation-focused interventions for well older people by estimating effect sizes for leisure engagement and ability in activities of daily living ( ADL ) and thereby identifying the most effective interventions .
METHODS	One hundred and seventy seven persons , 77-82 years old , living alone and without home help , were randomized to a control group ( CG ) , an individual intervention ( IG ) , an activity group ( AG ) , and a one-meeting discussion group ( DG ) .
METHODS	All interventions focused on occupational engagement and how persons can cope with age-related activity restrictions in order to enhance occupational engagement .
METHODS	Data were collected by blinded research assistants at baseline , three , and 12 months .
METHODS	Ordinal outcome data were converted , using Rasch measurement methods , to linear measures of leisure engagement and ADL ability .
METHODS	Standardized between-group effect sizes , Cohen 's d , were calculated .
RESULTS	While all groups showed a decline in leisure engagement and ADL over time , the IG and the DG were somewhat effective in minimizing the decline at both three and 12 months .
RESULTS	However , the effect sizes were small .
CONCLUSIONS	The findings indicate that occupation-focused interventions intended to minimize a decline in leisure engagement and ADL were sufficiently promising to warrant their further research .

###24245566
BACKGROUND	Atherosclerotic renal-artery stenosis is a common problem in the elderly .
BACKGROUND	Despite two randomized trials that did not show a benefit of renal-artery stenting with respect to kidney function , the usefulness of stenting for the prevention of major adverse renal and cardiovascular events is uncertain .
METHODS	We randomly assigned 947 participants who had atherosclerotic renal-artery stenosis and either systolic hypertension while taking two or more antihypertensive drugs or chronic kidney disease to medical therapy plus renal-artery stenting or medical therapy alone .
METHODS	Participants were followed for the occurrence of adverse cardiovascular and renal events ( a composite end point of death from cardiovascular or renal causes , myocardial infarction , stroke , hospitalization for congestive heart failure , progressive renal insufficiency , or the need for renal-replacement therapy ) .
RESULTS	Over a median follow-up period of 43 months ( interquartile range , 31 to 55 ) , the rate of the primary composite end point did not differ significantly between participants who underwent stenting in addition to receiving medical therapy and those who received medical therapy alone ( 35.1 % and 35.8 % , respectively ; hazard ratio with stenting , 0.94 ; 95 % confidence interval [ CI ] , 0.76 to 1.17 ; P = 0.58 ) .
RESULTS	There were also no significant differences between the treatment groups in the rates of the individual components of the primary end point or in all-cause mortality .
RESULTS	During follow-up , there was a consistent modest difference in systolic blood pressure favoring the stent group ( -2.3 mm Hg ; 95 % CI , -4.4 to -0.2 ; P = 0.03 ) .
CONCLUSIONS	Renal-artery stenting did not confer a significant benefit with respect to the prevention of clinical events when added to comprehensive , multifactorial medical therapy in people with atherosclerotic renal-artery stenosis and hypertension or chronic kidney disease .
CONCLUSIONS	( Funded by the National Heart , Lung and Blood Institute and others ; ClinicalTrials.gov number , NCT00081731 . )

###24681963
BACKGROUND	Long-acting 2-agonists and leukotriene receptor antagonists are two principal agents that can be added to inhaled corticosteroids ( ICS ) for patients with asthma that is not adequately controlled by ICS alone .
BACKGROUND	The Gly16Arg genotype of the 2-adrenergic receptor ( ADRB2 ) gene may influence the bronchodilator effects of 2-agonists .
BACKGROUND	We hypothesized that differential responses to long-acting 2-agonists or leukotriene receptor antagonists might be determined partly by the Gly16Arg polymorphism in Japanese asthma patients .
METHODS	This randomized , genotype-stratified , two-period crossover study included 80 patients with mild-to-moderate asthma ( 35 Arg/Arg and 45 Gly/Gly individuals ) .
METHODS	The primary study outcome was the difference in peak expiratory flow ( PEF ) ( PEF , l/min ) by genotype after 16 weeks of treatment with salmeterol ( PEFsal ) or montelukast ( PEFmon ) .
METHODS	In addition , multivariate analyses were used to identify independent factors that were predictive of responses to each treatment .
RESULTS	The mean PEFsal-PEFmon was 19.346.6 among Arg/Arg individuals and 16.851.5 among Gly/Gly individuals , indicating that the Gly16Arg genotype did not influence the differential bronchodilator effect of the two agents .
RESULTS	Multivariate analysis showed that higher peripheral eosinophil counts were associated with better response to salmeterol ( P < 0.05 ) .
CONCLUSIONS	The Gly16Arg genotype did not influence the differential bronchodilator effect of salmeterol or montelukast as an add-on therapy to ICS within 16 weeks of follow-up .
CONCLUSIONS	Higher peripheral eosinophil counts may be associated with better responses to salmeterol in combination with ICS .

###24300222
OBJECTIVE	To evaluate knowledge uptake from a parent-directed factsheet about managing pain during infant vaccinations , and the added influence of a pretest .
METHODS	Solomon 4-group randomized controlled trial .
METHODS	New mothers hospitalized after the birth of an infant were randomized to 1 of 4 groups : 2 included the intervention ( factsheet about pain management ) and 2 included the control ( information on another topic ) .
METHODS	A pretest was given to 1 intervention and 1 control group .
METHODS	Following maternal review of allocated information , posttests were administered in all groups .
METHODS	Both control groups received the information after posttesting .
METHODS	A follow-up telephone survey after 2 months measured knowledge retention and utilization of pain management interventions .
RESULTS	A total of 120 mothers participated ( July , 2012 to February , 2013 ) ; demographics did not differ among groups .
RESULTS	The 2 factsheet groups demonstrated more knowledge ( P < 0.05 ) about effective pain management ( mean without pretest : 5.6 [ SD = 2.0 ] ; with pretest : 6.9 [ 1.6 ] ) compared with the 2 control groups ( without pretest : 3.2 [ 2.2 ] ; with pretest : 3.4 [ 2.5 ] ) immediately after review ; and the factsheet and pretest group scored higher than the factsheet only group .
RESULTS	In groups with a prefactsheet baseline knowledge test , knowledge was higher at follow-up compared with baseline .
RESULTS	Follow-up knowledge and utilization of pain management interventions did not differ among groups .
CONCLUSIONS	The factsheet led to acute gains in knowledge and knowledge gains persisted after 2 months .
CONCLUSIONS	Acutely , knowledge was bolstered by the pretest .
CONCLUSIONS	These results can be used to guide future research and implementation of the factsheet .

###25188544
OBJECTIVE	This study investigated if a process-oriented training for health professionals will influence women 's use and reasons for using a nipple shield , the baby 's weight , and the duration of breastfeeding .
METHODS	An intervention was performed for health professionals that included a process-oriented training program on breastfeeding support .
METHODS	Primiparas living in either the intervention municipality or in a control municipality were asked to participate in a longitudinal study to evaluate the care given .
METHODS	Data collection for control group A ( CGA ) ( n = 162 ) started before the intervention was initiated .
METHODS	Data for control group B ( CGB ) ( n = 172 ) were collected simultaneously with those for the intervention group ( IG ) ( n = 206 ) .
METHODS	The mothers responded to questionnaires at 3 days , at 3 months , and at 9 months postpartum .
RESULTS	The mothers ' use of nipple shields related to the finding that if the women had a higher body mass index in the beginning of the pregnancy , the babies had difficulty in grasping over the nipple , and the mothers had pain or wound on the nipple .
RESULTS	For the mothers in the IG group , there was no significant difference if they had used nipple shields or not in relation to breastfeeding duration .
RESULTS	In contrast , the mothers in the control groups had a significant shorter breastfeeding duration if they had used nipple shields .
RESULTS	In the IG , there were no significant difference between the use of nipple shields and the babies ' weights at 3 or 9 months .
RESULTS	The babies of women in the CGB who used nipple shields had a significantly lower weight at 3 months than the babies of those who did not use nipple shields ( p = 0.02 ) .
CONCLUSIONS	A process-oriented training in breastfeeding counseling prolongs the duration of breastfeeding for women with breastfeeding problems , where the problems are remedied by the use of nipple shields .

###24559953
BACKGROUND	Although radiotherapy ( RT ) provides potential benefits for patients with hepatocellular carcinomas ( HCCs ) that are unsuitable for operation , the specific role of adjuvant RT in HCC after hepatectomy remains ill defined .
BACKGROUND	The current study 's aim was to evaluate the safety and efficacy of adjuvant RT for centrally located HCCs after narrow-margin ( < 1 cm ) hepatectomy .
METHODS	The study included 119 patients with centrally located HCCs who underwent narrow-margin hepatectomy between July 2007 and March 2012 .
METHODS	Patients were prospectively randomized to receive adjuvant RT ( n = 58 ) or were assigned to a control group ( n = 61 ) .
METHODS	Surgical outcomes , safety , and survival rates were evaluated .
RESULTS	Hepatectomy was successfully performed in all patients .
RESULTS	No cases of radiation-induced liver disease were observed .
RESULTS	One - , 3 - , and 5-year recurrence-free survival rates were 78.1 % , 56.5 % , and 36.9 % in the adjuvant RT group and 72.4 % , 40.1 % , and 16.0 % in the control group , respectively ( p = 0.06 , log-rank test ) .
RESULTS	Corresponding overall survival rates were 96.2 % , 72.6 % , 48.4 % , and 89.6 % , 74.5 % , 37.2 % , respectively ( p = 0.48 , log-rank test ) .
RESULTS	One - , 3 - , and 5-year recurrence-free survival rates in patients with small-diameter tumors ( 5 cm ) were 88.8 % , 67.4 % , 42.9 % in the adjuvant RT group and 82.3 % , 42.9 % , 21.5 % in the control group ( p = 0.03 , log-rank test ) .
RESULTS	Corresponding overall survival rates were 97.5 % , 75.3 % , 75.3 % , and 94.7 % , 84.1 % , 65.4 % , respectively ( p = 0.92 , log-rank test ) .
CONCLUSIONS	Adjuvant RT for centrally located HCCs after narrow-margin hepatectomy was technically feasible and relatively safe .
CONCLUSIONS	No significant between-group difference was observed in recurrence-free and overall survival .
CONCLUSIONS	The post-hoc subgroup comparison showed that adjuvant RT improved recurrence-free survival considerably , but not overall survival , in patients with small HCCs ( 5 cm ) .
CONCLUSIONS	More in-depth studies are needed to validate this finding .

###24617243
OBJECTIVE	To explore the optimized rehabilitation program in the treatment of post-stroke hemiplegia at the recovery stage .
METHODS	Based on the randomized controlled principle , 60 patients were randomized into an rehabilita tion + massage group ( group A ) and an rehabilitation + acupuncture group ( group B ) , 30 cases in each one .
METHODS	Bobath sport therapy and functional training were adopted in the two groups .
METHODS	In the group A , the massage therapy was added .
METHODS	The rolling method and palm-rubbing method were used on the affected side , the pressing , kneading and plucking methods were applied to Jianliao ( LI 15 ) , Jianzhen ( SI 9 ) , Quchi ( LI 11 ) , Huantiao ( GB 30 ) , Weizhong ( BL 40 ) , Chengshan ( BL 57 ) , Zusanli ( ST 36 ) and the other acu points ; and the nipping method was adopted at the twelve Jing-well points .
METHODS	In the group B , acupuncture was applied to Baihui ( BL 20 ) , Jianliao ( LI 15 ) , Quchi ( LI 11 ) , Shousanli ( LI 10 ) , Huantiao ( GB 30 ) , Yanglingquan ( GB 34 ) , Jiexi ( ST 41 ) and the other acupoints .
METHODS	The treatment was given once a day , 5 treatments a week in the two groups .
METHODS	The efficacy was evaluated in 3 weeks .
METHODS	Fugl-Meyer scale , Barthel index ( BI ) score , modified Rankin scale and stroke-specific quality of life ( SS-QOL ) were used to assess the limb motor function , the activity of daily life ( ADL ) , independent activity of life and the quality of life of the patients in the two groups before and after treatment .
METHODS	Based on the total cost and benefit , the health economics evaluation was conducted in the patients of the two groups .
RESULTS	The treatments all improved the limb motor function ( group A : 26.00 ( 22 ) vs 37.00 ( 33 ) ; group B : 30.50 ( 21 ) vs 39.50 ( 36 ) ) , the independent activity of life , ADL ( group A : 43.50 + / - 22.25 vs 57.50 + / - 22.25 ; group B : 52.83 + / - 16.59 vs 66.67 + / - 12.82 ) and the quality of life ( group A : 122.23 + / - 30.00 vs 145.50 + / - 28.14 ; group B : 132.43 + / - 23.87 vs 151.47 + / - 22.37 ) in the patients of the two groups .
RESULTS	The differences in all the indices were significant statistically before and after treatment in the two groups ( all P < 0.05 ) .
RESULTS	Above indices after treatment were not different obviously between the two groups ( all P > 0.05 ) .
RESULTS	In terms of health economics , the expense was decreased by RMB 688.48 while BI was increased by every 5 score in group A in comparison with the group B.
CONCLUSIONS	Both the rehabilitation and massage therapy and the rehabilitation and acupuncture therapy improve the limb motor function and the quality of life in the patients of post-stroke hemiplegia .
CONCLUSIONS	The therapeutic efficacies are similar between the two therapeutic programs .
CONCLUSIONS	The program of rehabilitation and massage is more economical in the aspects of ADL improvement , being advantageous at simple operation and low cost .

###24903620
BACKGROUND	Too few young people engage in behaviours that reduce the risk of morbidity and premature mortality , such as eating healthily , being physically active , drinking sensibly and not smoking .
BACKGROUND	This study sought to assess the efficacy and cost-effectiveness of a theory-based online health behaviour intervention ( based on self-affirmation theory , the Theory of Planned Behaviour and implementation intentions ) targeting these behaviours in new university students , in comparison to a measurement-only control .
METHODS	Two-weeks before starting university all incoming undergraduates at the University of Sheffield were invited to take part in a study of new students ' health behaviour .
METHODS	A randomised controlled design , with a baseline questionnaire , and two follow-ups ( 1 and 6 months after starting university ) , was used to evaluate the intervention .
METHODS	Primary outcomes were measures of the four health behaviours targeted by the intervention at 6-month follow-up , i.e. , portions of fruit and vegetables , metabolic equivalent of tasks ( physical activity ) , units of alcohol , and smoking status .
RESULTS	The study recruited 1,445 students ( intervention n = 736 , control n = 709 , 58 % female , Mean age = 18.9 years ) , of whom 1,107 completed at least one follow-up ( 23 % attrition ) .
RESULTS	The intervention had a statistically significant effect on one primary outcome , smoking status at 6-month follow-up , with fewer smokers in the intervention arm ( 8.7 % ) than in the control arm ( 13.0 % ; Odds ratio = 1.92 , p = .010 ) .
RESULTS	There were no significant intervention effects on the other primary outcomes ( physical activity , alcohol or fruit and vegetable consumption ) at 6-month follow-up .
CONCLUSIONS	The results of the RCT indicate that the online health behaviour intervention reduced smoking rates , but it had little effect on fruit and vegetable intake , physical activity or alcohol consumption , during the first six months at university .
CONCLUSIONS	However , engagement with the intervention was low .
CONCLUSIONS	Further research is needed before strong conclusions can be made regarding the likely effectiveness of the intervention to promote health lifestyle habits in new university students .
BACKGROUND	Current Controlled Trials , ISRCTN67684181 .

###25865175
OBJECTIVE	Frequent self-weighing is linked with weight management success , but concern has been raised about its possible association with unhealthy practices .
OBJECTIVE	This study examined the association of self-weighing with other weight control behaviors in a sample for whom frequent weighing might be questioned -- namely , normal-weight or overweight ( BMI of 21-29 .9 ) young adults ( age 18-35 ) .
METHODS	Participants ( N = 583 ; mean [ SD ] age = 27.7 [ 4.4 ] ; BMI = 25.4 [ 2.6 ] ) entering the Study of Novel Approaches to Weight Gain Prevention ( SNAP ) completed objective measures of weight and physical activity and self-reported weight history , use of healthy and unhealthy weight control strategies , depressive symptoms , and dietary intake .
RESULTS	Daily self-weighing was reported by 11 % of participants , and 23 % weighed several times per week .
RESULTS	Frequent weighing was not associated with current BMI , gender , or age but was associated with being further below one 's highest weight , history of dieting , and perceived difficulty maintaining weight .
RESULTS	Frequent weighing was associated with healthy weight management strategies , but not with unhealthy practices or depressive symptoms .
CONCLUSIONS	In this sample , frequent self-weighing appears to be part of a constellation of healthy weight control behaviors used to counteract a perceived tendency toward weight gain .
CONCLUSIONS	SNAP follow-up will determine whether frequent self-weighing helps prevent weight gain .

###25332253
OBJECTIVE	This prospective phase II study was designed to assess disease control and to describe acute and late adverse effects of treatment with proton radiotherapy in children with rhabdomyosarcoma ( RMS ) .
METHODS	Fifty-seven patients with localized RMS ( age 21 years or younger ) or metastatic embryonal RMS ( age 2 to 10 years ) were enrolled between February 2005 and August 2012 .
METHODS	All patients were treated with chemotherapy based on either vincristine , actinomycin , and cyclophosphamide or vincristine , actinomycin , and ifosfamide-based chemotherapy and proton radiation .
METHODS	Surgical resection was based on tumor site and accessibility .
METHODS	Common Terminology Criteria for Adverse Events , Version 3.0 , was used to assess and grade adverse effects of treatment .
METHODS	Concurrent enrollment onto Children 's Oncology Group or European Pediatric Sarcoma Study Group protocols was allowed .
METHODS	All pathology and imaging were reviewed at the treating institution .
RESULTS	Median follow-up was 47 months ( range , 14 to 102 months ) for survivors .
RESULTS	Five-year event-free survival ( EFS ) , overall survival ( OS ) , and local control ( LC ) were 69 % , 78 % , and 81 % , respectively , for the entire cohort .
RESULTS	The 5-year LC by risk group was 93 % for low-risk and 77 % for intermediate-risk disease .
RESULTS	There were 13 patients with grade 3 acute toxicity and three patients with grade 3 late toxicity .
RESULTS	There were no acute or late toxicities higher than grade 3 .
CONCLUSIONS	Five-year LC , EFS , and OS rates were similar to those observed in comparable trials that used photon radiation .
CONCLUSIONS	Acute and late toxicity rates were favorable .
CONCLUSIONS	Proton radiation appears to represent a safe and effective radiation modality for pediatric RMS .

###25577838
OBJECTIVE	To compare the perioperative data , pathological results and functional outcomes of transvesical single - site laparoscopic radical prostatectomy ( TVSSLRP ) with those of nerve-sparing extraperitoneal laparoscopic radical prostatectomy ( nsELRP ) in the treatment of low-risk prostate cancer ( PCa ) .
METHODS	Fifty patients with low-risk organ-confined PCa were randomly assigned to two groups of equal number to receive TVSSLRP and nsELRP , respectively .
METHODS	Comparisons were made between the two groups of patients in such demographic and baseline data as age , comorbidity , body mass index ( BMI ) , serum prostate-specific antigen ( PSA ) , prostate volume , bioptic Gleason score , clinical stage , IIEF-5 score , nocturnal penile tumescence ( NPT ) , penile brachial index ( PBI ) , and penile arterial blood flow velocity as well as in such surgery-related parameters as operation duration , blood loss , blood transfusion , intraoperative complications , positive surgical margin , catheterization time , hospital stay , and postoperative Gleason score , pathologic stage , urinal pad use , PSA level , IIEF-5 score , NPT , PBI and PABFV .
RESULTS	All the operations were successfully performed .
RESULTS	There were no statistically significant differences between the two groups either in the demographic and baseline data or in intraoperative blood loss , blood transfusion rate , complications , and positive surgical margin .
RESULTS	No intraoperative complications and positive surgical margins were found in either group .
RESULTS	Compared with nsELRP , TVSSLRP achieved a significantly shorter operation duration ( [ 151.46 40.68 ] min vs [ 105.92 26.21 ] min , P < 0.05 ) , catheterization time ( [ 13.01 1.64 ] d vs [ 11.24 1.17 ] d , P < 0.05 ) , and hospital stay ( [ 15.76 4.65 ] d vs [ 12.92 4.29 ] d , P < 0.05 ) .
RESULTS	On the first day and at 1 , 3 and 6 months after catheter removal , the urinary continence rates in the TVSSLRP and nsELRP groups were 84 % vs 52 % ( P < 0.05 ) , 100 % vs 84 % , 100 % vs 96 % , and 100 % vs 96 % , respectively ; and at 3 , 6 and 12 months after surgery , the erectile potency rates were 48 % vs 28 % ( P < 0.05 ) , 64 % vs 52 % , and 76 % vs 68 % , respectively , with an IIEF-5 score 18 , all evidently higher in the TVSSLRP than in the nsELRP group .
RESULTS	The penile brachial index and arterial blood flow velocity of the two groups of patients exhibited no significant differences before and after surgery , nor did postoperative complications ( grade II ) between the TVSSLRP and nsELRP groups ( 32 % vs 40 % , P > 0.05 ) .
RESULTS	The Gleason score and pathologic stage were increased after surgery , but with remarkable differences between the two groups ( P > 0.05 ) .
RESULTS	No biochemical recurrence was found in either group during a 12-month follow-up .
CONCLUSIONS	With the advantages of safety and rapid postoperative recovery , both TVSSLRP and nsELRP are feasible for the treatment of low-risk organ-confined PCa , but the former may achieve an earlier recovery of urinary continence and erectile function than the latter .

###25287554
OBJECTIVE	The objective of this study was to examine the associations between baseline electroencephalogram ( EEG ) - assessed brain oscillations and subsequent response to four neuromodulatory treatments .
OBJECTIVE	Based on available research , we hypothesized that baseline theta oscillations would prospectively predict response to hypnotic analgesia .
OBJECTIVE	Analyses involving other oscillations and the other treatments ( meditation , neurofeedback , and both active and sham transcranial direct current stimulation ) were viewed as exploratory , given the lack of previous research examining brain oscillations as predictors of response to these other treatments .
METHODS	Randomized controlled study of single sessions of four neuromodulatory pain treatments and a control procedure .
METHODS	Thirty individuals with spinal cord injury and chronic pain had their EEG recorded before each session of four active treatments ( hypnosis , meditation , EEG biofeedback , transcranial direct current stimulation ) and a control procedure ( sham transcranial direct stimulation ) .
RESULTS	As hypothesized , more presession theta power was associated with greater response to hypnotic analgesia .
RESULTS	In exploratory analyses , we found that less baseline alpha power predicted pain reduction with meditation .
CONCLUSIONS	The findings support the idea that different patients respond to different pain treatments and that between-person treatment response differences are related to brain states as measured by EEG .
CONCLUSIONS	The results have implications for the possibility of enhancing pain treatment response by either 1 ) better patient/treatment matching or 2 ) influencing brain activity before treatment is initiated in order to prepare patients to respond .
CONCLUSIONS	Research is needed to replicate and confirm the findings in additional samples of individuals with chronic pain .

###24698648
OBJECTIVE	The purpose of this study was to assess the efficacy of a 12 week , self-managed , community-based stretching program on musculoskeletal fitness , musculoskeletal symptoms , and acculturative stress , in Korean-Chinese female migrant workers in Korea .
METHODS	This was a randomized controlled trial with random assignment of eligible full-time Korean-Chinese female migrant workers to a stretching exercise intervention ( n = 40 ) or an enhanced stretching exercise intervention ( n = 40 ) condition .
METHODS	Both conditions received a 6 min stretching exercise program that included an orientation and three work-related musculoskeletal disorder ( WMSD ) educational classes .
METHODS	Between educational classes , the enhanced stretching exercise condition also received mobile phone text messaging and telephone counseling to increase self-efficacy ( confidence in overcoming barriers ) and provide social support .
METHODS	Flexibility , muscle strength , musculoskeletal symptoms , and acculturative stress were assessed at baseline and 12 weeks .
RESULTS	Significant increase in flexibility was noted for both conditions , but acculturative stress was significantly reduced only in the standard intervention condition .
RESULTS	Muscle strength and WMSD symptoms had no significant changes at the 12 week follow up in both conditions .
CONCLUSIONS	The 12 week , self-managed , community-based , stretching exercise program was effective to increase flexibility .
CONCLUSIONS	The standard stretching intervention without any enhancements may be a more cost-effective way to increase flexibility .
CONCLUSIONS	Longitudinal studies , however , are needed to see if the long-term effects are greater in the enhanced intervention for the migrant worker population .

###25807814
OBJECTIVE	To determine the effects of Syndrome Differentiated Chinese Medicine ( TCM ) Therapy on ( CKD ) 1-2 stage chronic kidney disease with proteinuria .
METHODS	A prospective randomized control study was undertaken in 11 centers .
METHODS	A total of 396 chronic nephritis patients were divided into a treatment group ( n = 297 ) and a control group ( n = 99 ) .
METHODS	Their TCM syndrome was classified as `` Qi and Yin Deficiency of spleen and kidney '' or `` Qi and Yang Deficiency of spleen and kidney '' , with accompanying syndromes showing as `` water and dampness '' , `` damp-heat '' , and `` blood stasis '' .
METHODS	Patients in the treatment group took a dose of Chinese medicine daily in response to their syndromes , while the controls took 50 mg/d losartan .
METHODS	The course of treatment was 24 weeks .
METHODS	Changes of 24-hour urinary protein excretion and glomerular filtration rate ( eGFR ) before and after treatments ( 4 , 8 , 12 , 16 , 20 , 24 weeks ) , as well as clinical efficacy ( after 4 , 16 , 24 weeks treatments ) were measured .
RESULTS	361 patients were included in the final program participants comply analysis ( PPS ) .
RESULTS	Patients in the treatment group showed gradual decreased 24-hour urinary protein excretion , whereas the controls remained unchanged .
RESULTS	Significant differences in 24-hour urinary protein excretion appeared between the experimental and control group at week 20 and 24 ( P < 0.05 ) .
RESULTS	eGFR decreased in all of the patients after treatments ( P = 0.0014 ) .
RESULTS	At three follow-up points , patients in the treatment group had higher eGFR than the controls , but without statistical significance ( P > 0.05 ) .
RESULTS	Significant differences in clinical remission rate , marked effect rate and total effective rate were observed between the treatment and control groups at week 24 ( P < 0.001 ) .
CONCLUSIONS	Syndrome differentiated TCM therapy can reduce the level of proteinuria in CKD 1-2 nephritis patients , promoting clinical effectiveness and protecting renal functions .

###25681448
OBJECTIVE	To evaluate the effects of oral delayed-release dimethyl fumarate ( DMF ; also known as gastro-resistant DMF ) on MRI lesion activity and load , atrophy , and magnetization transfer ratio ( MTR ) measures from the Comparator and an Oral Fumarate in Relapsing-Remitting Multiple Sclerosis ( CONFIRM ) study .
METHODS	CONFIRM was a 2-year , placebo-controlled study of the efficacy and safety of DMF 240 mg twice ( BID ) or 3 times daily ( TID ) in 1,417 patients with relapsing-remitting multiple sclerosis ( RRMS ) ; subcutaneous glatiramer acetate 20 mg once daily was included as an active reference comparator .
METHODS	The number and volume of T2-hyperintense , T1-hypointense , and gadolinium-enhancing ( Gd + ) lesions , as well as whole brain volume and MTR , were assessed in 681 patients ( MRI cohort ) .
RESULTS	DMF BID and TID produced significant and consistent reductions vs placebo in the number of new or enlarging T2-hyperintense lesions and new nonenhancing T1-hypointense lesions after 1 and 2 years of treatment and in the number of Gd + lesions at week 24 , year 1 , and year 2 .
RESULTS	Lesion volumes were also significantly reduced .
RESULTS	Reductions in brain atrophy and MTR changes with DMF relative to placebo did not reach statistical significance .
CONCLUSIONS	The robust effects on MRI active lesion counts and total lesion volume in patients with RRMS demonstrate the ability of DMF to exert beneficial effects on inflammatory lesion activity in multiple sclerosis , and support DMF therapy as a valuable new treatment option in RRMS .
METHODS	This study provides Class I evidence of reduction in brain lesion number and volume , as assessed by MRI , over 2 years of delayed-release DMF treatment .

###25794218
BACKGROUND	Percutaneous vertebroplasty is a widely used vertebral augmentation procedure for treating osteoporotic vertebral compression fractures ( OVCFs ) .
BACKGROUND	But high cement leakage rate caused by a low-viscosity cement and high injection pressure has limited its general use .
BACKGROUND	Balloon kyphoplasty ( BKP ) and high-viscosity cement vertebroplasty ( HVCV ) are 2 modifications of vertebroplasty designed to decrease cement leakage .
OBJECTIVE	To assess the safety and efficacy of HVCV compared with BKP .
METHODS	A prospective cohort study .
METHODS	Department of Spine Surgery , an affiliated hospital of a medical university .
METHODS	One hundred seven patients suffering from painful OVCFs were randomly assigned into HVCV or BKP groups .
METHODS	Visual Analog Scale ( VAS ) , Oswestry Disability Index ( ODI ) , cement leakage , and vertebral height restoration were evaluated .
METHODS	All occurring complications and injected cement volumes were recorded .
METHODS	The follow-up time was one year .
RESULTS	VAS and ODI scores improved in both groups , and did not differ significantly between the 2 groups .
RESULTS	More cement was used in the BKP group than in HVCV group ( 4.22 vs. 3.31 mL , P < 0.0001 ) .
RESULTS	The incidence of cement leakage in the HVCV group was lower than that of the BKP group ( 13.24 % vs 30.56 % , P < 0.05 ) .
RESULTS	No symptomatic cement leakages occurred in the HVCV group .
RESULTS	In the BKP group , one patient experienced discogenic back pain related to a disc leak , and another patient had asymptomatic cement emboli in the lung related to venous leakage .
RESULTS	The mean compression rate before the procedure was 29.98 % in the HVCV group and 28.67 % in the BKP group ( P = 0.94 ) .
RESULTS	The vertebral height was improved significantly and maintained at one-year follow-up in both groups .
RESULTS	BKP was more effective in vertebral height restoration than HVCV ( 44.87 % vs. 23.93 % , P < 0.0001 ) .
RESULTS	There was one case of a new adjacent vertebral fracture in the HVCV group ( 2 % ) , and 4 cases of new nonadjacent vertebral fractures in the BKP group ( 7.84 % ) ( P = 0.18 ) .
CONCLUSIONS	A single-center and relatively small-sample size study .
CONCLUSIONS	HVCV and BKP are safe and effective in improving quality of life and relieving pain .
CONCLUSIONS	HVCV has a lower cement leakage rate , whereas BKP is more effective in vertebral height restoration .
CONCLUSIONS	Subsequent fractures are not different between the 2 groups .

###25068411
BACKGROUND	This study aims to compare and evaluate the effect of adding ketamine as an adjunct to lidocaine for intravenous regional anesthesia ( IVRA ) on intraoperative and postoperative analgesia , the onset and recovery times of sensory and motor block , and tourniquet pain .
METHODS	Forty patients undergoing surgery of the hand or forearm under IVRA were randomly assigned to receive lidocaine 3 mg/kg ( group 1 ) or lidocaine 3 mg/kg plus ketamine 50 mg ( group 2 ) diluted to 40 mL with normal saline .
METHODS	Assessment parameters included the onset and recovery times of sensory and motor block , tourniquet pain , intraoperative hemodynamics , surgeon and patient satisfaction , postoperative pain , time of first analgesic request , total analgesic consumption , and adverse effects in the first 24 hours postoperatively .
RESULTS	Groups 1 and 2 were comparable in demographic and surgical parameters .
RESULTS	There were no differences between groups in intraoperative hemodynamics , onset and recovery times of sensory and motor block , or surgeon satisfaction index .
RESULTS	Compared with group 1 , group 2 patients showed less tourniquet pain , prolonged time to first request for postoperative rescue analgesia ( 5.5 1.3 vs 20.4 3.7 hours , P < 0.001 ) , lower postoperative diclofenac consumption ( 120.00 45.23 vs 55.1 0.00 mg , P < 0.001 ) , lower scores for postoperative pain as measured by the Verbal Rating Scale , higher patient satisfaction index , and a nonsignificant difference in the incidence of postoperative adverse effects between groups .
CONCLUSIONS	The addition of ketamine to lidocaine in patients receiving IVRA significantly reduced intraoperative and postoperative analgesic requirements and improved patient satisfaction without causing significant adverse effects .

###25300863
BACKGROUND	Antiretroviral pre-exposure prophylaxis ( PrEP ) , with daily oral tenofovir disoproxil fumarate or tenofovir disoproxil fumarate in combination with emtricitabine , has been shown to be efficacious for HIV-1 prevention .
BACKGROUND	Although the use of more than one antiretroviral agent is essential for effective HIV-1 treatment , more than one agent might not be required for effective prophylaxis .
BACKGROUND	We assessed the efficacy of single-agent tenofovir disoproxil fumarate relative to combination emtricitabine plus tenofovir disoproxil fumarate as PrEP .
METHODS	We did a randomised , double-blind , placebo-controlled three-group phase 3 trial of daily oral tenofovir disoproxil fumarate and emtricitabine plus tenofovir disoproxil fumarate PrEP in HIV-1 uninfected individuals in heterosexual HIV-1 serodiscordant couples from Kenya and Uganda .
METHODS	After an interim review , the trial 's placebo group was discontinued and thereafter the active groups were continued , and participants initially randomly assigned to placebo were offered rerandomisation in a 1:1 ratio to tenofovir disoproxil fumarate or emtricitabine plus tenofovir disoproxil fumarate as PrEP .
METHODS	The primary endpoints were HIV-1 seroconversion and safety .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00557245 .
RESULTS	4410 ( 996 % ) of 4427 couples received tenofovir disoproxil fumarate or emtricitabine plus tenofovir disoproxil fumarate and were followed up for HIV-1 acquisition .
RESULTS	Of 52 incident HIV-1 infections , 31 occurred in individuals assigned tenofovir disoproxil fumarate ( incidence 071 cases per 100 person-years ) and 21 were in those assigned emtricitabine plus tenofovir disoproxil fumarate ( 048 cases per 100 person-years ) ; HIV-1 incidence in the placebo group until discontinuation was two cases per 100 person-years .
RESULTS	HIV-1 prevention efficacy with emtricitabine plus tenofovir disoproxil fumarate was not significantly different from that of tenofovir disoproxil fumarate alone ( hazard ratio [ HR ] 067 , 95 % CI 039-117 ; p = 016 ) .
RESULTS	Detection of tenofovir in plasma samples , compared with no detection and as measured in seroconverters and a subset of non-seroconverters , was associated with an 85 % relative risk reduction in HIV-1 acquisition for the tenofovir disoproxil fumarate group ( HR 015 , 95 % CI 006-037 ; p < 00001 ) and 93 % for the emtricitabine plus tenofovir disoproxil fumarate group ( 007 , 002-023 ; p < 00001 ) .
RESULTS	No significant differences were noted in the frequency of deaths , serious adverse events , or serum creatinine and phosphorus abnormalities between the two groups .
CONCLUSIONS	These results do not rule out the potential for a slight difference in HIV-1 protection with tenofovir disoproxil fumarate compared with emtricitabine plus tenofovir disoproxil fumarate , but show that once-daily oral tenofovir disoproxil fumarate or emtricitabine plus tenofovir disoproxil fumarate regimens both provide high protection against HIV-1 acquisition in heterosexual men and women .
BACKGROUND	Bill & Melinda Gates Foundation and US National Institutes of Health .

###25769593
BACKGROUND	The safety of healthy volunteer donors is one of the most important issues in living-donor liver transplantation .
BACKGROUND	Use of the Pringle maneuver during donor hepatectomy can result in liver ischemia-reperfusion ( IR ) injury .
BACKGROUND	The objective of this study was to examine the effects of isoflurane and propofol on IR injury caused by the Pringle maneuver during donor hepatectomy .
METHODS	A total of 70 American Society of Anesthesiology I-II donors aged 18-65 years who underwent hepatectomy were included in the study .
METHODS	The patients were randomly divided into 2 groups : propofol and isoflurane .
METHODS	Plasma superoxide dismutase ( SOD ) , malondialdehyde ( MDA ) , total oxidative status ( TOS ) , total antioxidant capacity ( TAC ) , and oxidative stress index ( OSI ) were measured before surgery ( t0 ) and after surgery ( t1 ) .
RESULTS	There were no statistically significant differences in demographic features , anesthesia , and times of surgery between the groups ( P > .05 ) .
RESULTS	Plasma TAC levels at t0 and t1 were significantly lower in the propofol group than in the isoflurane group ( P < .05 ) .
RESULTS	OSI at t1 was significantly higher in the propofol group than in the isoflurane group ( P < .05 ) .
RESULTS	MDA levels were significantly higher in the propofol group than in the isoflurane group at t0 ( P < .05 ) .
RESULTS	MDA levels level were significantly higher in the isoflurane group than in the propofol group at t1 ( P < .05 ) .
CONCLUSIONS	Propofol may have protective effects against IR injury caused by the Pringle maneuver during donor hepatectomy in living-donor transplantations .
CONCLUSIONS	However , the effectiveness of propofol for clinical use needs to be investigated further .

###25173342
BACKGROUND	The aim of this study was to determine whether maternal vitamin supplementation affects long-term mortality and morbidity of children born to HIV-infected mothers .
METHODS	In total , 1078 HIV-infected pregnant woman were enrolled in a double-blind , 22 factorial , randomised , placebo-controlled trial in Tanzania .
METHODS	Data were collected for 874 children at monthly clinic visits through a median age of 51 months .
RESULTS	Maternal receipt of multivitamins ( HR = 0.93 ; 95 % CI : 0.70-1 .22 ) or vitamin A ( HR = 1.00 ; 95 % CI : 0.76-1 .32 ) did not affect all-cause child mortality through age 5 years .
RESULTS	Among HIV-negative children , maternal multivitamin supplementation was associated with a lower mortality rate up to 5 years ( HR = 0.60 ; 95 % CI : 0.38-0 .95 ) , primarily in children < 2 years of age .
RESULTS	Maternal vitamin A supplementation did not significantly affect child mortality up to 5 years ( HR = 0.76 ; 95 % CI : 0.48-1 .20 ) .
RESULTS	Children born to mothers who received multivitamins had a lower risk of all types of diarrhoea ( RR = 0.86 ; 95 % CI : 0.75-0 .98 ) through 5 years of age .
RESULTS	The reduced risk of watery diarrhoea persisted in children from 2-5 years of age ( RR = 0.71 ; 95 % CI : 0.54-0 .95 ) .
CONCLUSIONS	Maternal vitamin supplementation during pregnancy and lactation may be associated with long-lasting affects in HIV-exposed children [ ClinicalTrials.gov Identifier : NCT00197743 ] .

###24875748
OBJECTIVE	To investigate staff and trainer perspectives on the barriers and facilitators to implementing a complex intervention to help staff support the recovery of service users with a primary diagnosis of psychosis in community mental health teams .
METHODS	Process evaluation nested within a cluster randomised controlled trial ( RCT ) .
METHODS	28 interviews with mental health care staff , 3 interviews with trainers , 4 focus groups with intervention teams and 28 written trainer reports .
METHODS	14 community-based mental health teams in two UK sites ( one urban , one semi-rural ) who received the intervention .
RESULTS	The factors influencing the implementation of the intervention can be organised under two over-arching themes : Organisational readiness for change and Training effectiveness .
RESULTS	Organisational readiness for change comprised three sub-themes : NHS Trust readiness ; Team readiness ; and Practitioner readiness .
RESULTS	Training effectiveness comprised three sub-themes : Engagement strategies ; Delivery style and Modelling recovery principles .
CONCLUSIONS	Three findings can inform future implementation and evaluation of complex interventions .
CONCLUSIONS	First , the underlying intervention model predicted that three areas would be important for changing practice : staff skill development ; intention to implement ; and actual implementation behaviour .
CONCLUSIONS	This study highlighted the importance of targeting the transition from practitioners ' intent to implement to actual implementation behaviour , using experiential learning and target setting .
CONCLUSIONS	Second , practitioners make inferences about organisational commitment by observing the allocation of resources , Knowledge Performance Indicators and service evaluation outcome measures .
CONCLUSIONS	These need to be aligned with recovery values , principles and practice .
CONCLUSIONS	Finally , we recommend the use of organisational readiness tools as an inclusion criteria for selecting both organisations and teams in cluster RCTs .
CONCLUSIONS	We believe this would maximise the likelihood of adequate implementation and hence reduce waste in research expenditure .
BACKGROUND	Controlled-Trials .
BACKGROUND	com ISRCTN02507940 .

###25395384
BACKGROUND	This study aimed to compare emergence agitation following sevoflurane and desflurane anaesthesia in adults undergoing orthognathic surgery .
BACKGROUND	The hypothesis was that there might be a difference in the incidence of emergence agitation following sevoflurane and desflurane anaesthesia considering the difference in blood solubility and speed of recovery between the two .
METHODS	In this prospective randomised double-blind study , 144 adults undergoing orthognathic surgery were randomly allocated to either sevoflurane or desflurane anaesthesia .
METHODS	The incidence of emergence agitation and possible causative factors were then compared between the groups .
RESULTS	The incidence of emergence agitation was lower in the desflurane group than in the sevoflurane group ( 24 % vs. 71 % , P < 0.001 ) .
RESULTS	In addition , the time intervals between the discontinuation of anaesthetics and the first response , extubation , and discharge from post-anaesthesia care unit were significantly shorter in the desflurane group ( P = 0.002 , P < 0.001 and P = 0.003 , respectively ) .
RESULTS	The other variables were similar in the two groups .
CONCLUSIONS	In adults undergoing orthognathic surgery , desflurane anaesthesia was associated with less emergence agitation than was sevoflurane anaesthesia .

###25440887
OBJECTIVE	The aim of this study was to investigate the hypothesis that a novel biodegradable polymer-coated , cobalt-chromium ( CoCr ) , sirolimus-eluting stent ( BP-SES ) is noninferior in safety and efficacy outcomes compared with a durable polymer ( DP ) - SES .
BACKGROUND	No randomized trials have the compared safety and efficacy of BP-SES versus DP-SES on similar CoCr platforms , thereby isolating the effect of the polymer type .
METHODS	In this prospective , single-blind , randomized trial conducted at 32 Chinese sites , 2,737 patients eligible for coronary stenting were treated with BP - or DP-SES in a 2:1 ratio .
METHODS	The primary endpoint was 12-month target lesion failure ( TLF ) , a composite of cardiac death , target vessel myocardial infarction , or clinically indicated target lesion revascularization .
METHODS	Secondary endpoints included TLF components , and definite/probable stent thrombosis .
RESULTS	At 12 months , the difference in the primary endpoint of TLF between BP-SES ( 6.3 % ) and DP-SES ( 6.1 % ) groups was 0.25 % ( 95 % confidence interval : -1.67 % to 2.17 % , p for noninferiority = 0.0002 ) , demonstrating noninferiority of BP-SES to DP-SES .
RESULTS	Individual TLF components of cardiac death ( 0.7 % vs. 0.6 % , p = 0.62 ) , target vessel myocardial infarction ( 3.6 % vs. 4.3 % , p = 0.39 ) , and clinically indicated target lesion revascularization ( 2.6 % vs. 2.2 % , p = 0.50 ) were similar , as were low definite/probable stent thrombosis rates ( 0.4 % vs. 0.6 % , p = 0.55 ) .
CONCLUSIONS	In this large-scale real-world trial , BP-SES was noninferior to DP-SES for 1-year TLF .
CONCLUSIONS	( Evaluate Safety and Effectiveness of the Tivoli DES and the Firebird DES for Treatment of Coronary Revascularization ; NCT01681381 ) .

###24635935
BACKGROUND	Tinnitus , a subjective auditory perception of sounds or noise not triggered by external auditory stimuli , carries considerable morbidity .
BACKGROUND	To date , pharmacological , physical or behavioral therapy is the mainstay of management .
METHODS	We compared repetitive transcranial magnetic stimulation ( rTMS ) of 1000 or 2000 stimulations/day at 1 Hz and 110 % of the motor threshold for 5 consecutive days over the left auditory cortex .
METHODS	Ratings based on the Tinnitus Handicap Inventory ( THI ) rating scale were completed weekly for 4 weeks .
METHODS	None of the patients had significant hearing impairment .
RESULTS	All 28 patients ( age range 21-72 ; 18 men ) tolerated rTMS well and no adverse effects were observed .
RESULTS	Analysis of variance ( ANOVA ) showed significant decrease in THI scores over the entire time period ( F ( 1,26 ) = 11.33 , p = 0.002 ) .
RESULTS	At every weekly time point of evaluation , ANOVA with repeated measures demonstrated significantly lower THI score compared to baseline ( p < 0.02 for all ) .
RESULTS	RTMS treatment had resulted in tinnitus reduction in the range of 15-25 % over the 4 week period .
RESULTS	Separately , ANOVA also demonstrated significantly reducing THI for both the 1000 pulse ( F ( 1,14 ) = 4.8 , p = 0.04 ) and 2000 pulse ( F ( 1,14 ) = 6.56 , p = 0.02 ) rTMS treatment arms .
RESULTS	Comparison of THI ratings between the 2 treatment arms did not result in significant difference ( F ( 1,26 ) = 1.48 , p = 0.24 ) .
CONCLUSIONS	The present study has revalidated the efficacy and safety of rTMS for improving tinnitus up to 4 weeks post-treatment in Asians .
CONCLUSIONS	However , there was no significant difference with THI evaluation between the 1000 pulse and 2000 pulse treatment arms .

###25179977
BACKGROUND	To evaluate the impact of remote ischemic preconditioning ( RIPC ) on clinical outcome , biological markers of myocardial injury , and its safety in patients undergoing on-pump coronary artery bypass grafting ( CABG ) .
METHODS	This study was conducted at Ch .
METHODS	Pervaiz Elahi Institute of Cardiology ( CPEIC ) in Multan .
METHODS	The study took place from March 2012 to June 2013 .
METHODS	Patients were randomly placed into two groups .
METHODS	Group A ( N = 32 ) did not undergo RIPC ; Group B ( N = 35 ) received RIPC after induction of anesthesia .
METHODS	Similar standard general anesthesia , cardiopulmonary technique , myocardial protection strategies , and surgical techniques were used in both groups except the protocol for RIPC .
METHODS	Following postoperative outcome , i.e. cardiac defibrillation after removal of aortic cross clamp during the period of rewarming , demand for intra-aortic balloon pump ( IABP ) , demand for antiarrhythmic before leaving the operation room , postoperative creatine kinase-myocardial band ( CK-MB ) level ( at 1h , 12h , 24h , and 48h after surgery ) , postoperative serum creatinine level on first postoperative day , postoperative ejection fraction ( EF ) on third postoperative day , in-hospital mortality , and one-year mortality were noted , prospectively .
METHODS	Safety of protocol of RIPC was estimated by limb ischemia monitored by pulse oximetry during and after procedure of RIPC and postoperative neurapraxia by nerve examination of right upper limb .
RESULTS	Post aortic cross clamp release cardiac defibrillation , demand for IABP , demand for high inotropes , and use of antiarrhythmic in the operation room were statistically insignificant in the non-RIPC and RIPC group with P values of .54 , .78 , .16 , and .16 , respectively .
RESULTS	Mean postoperative CK-MB level ( IU/L ) showed the following results : At 1h ( Group A 20.94 + 1.66 , Group B 20.57 + 1.54 , P = .35 ) , at 12h ( Group A 27.13 + 1.85 , Group B 28.05 + 3.04 , P = .135 ) , at 24h ( Group A 27.63 + 1.7 , Group B 27.85 + 2.2 , P = .63 ) , and at 48h ( Group A 22.95 + 2.76 , Group B 23.27 + 3.6 , P = .69 ) .
RESULTS	First postoperative day serum creatinine ( Group A 1.29 + 0.395 , Group B 1.33 + 0.57 , P = .77 ) and postoperative ejection fraction percentage on the third postoperative day ( Group A 50.78 + 8.72 , Group B 50.57 + 8.38 , P = .92 ) showed no statistical difference between two groups .
RESULTS	Postoperative low cardiac output state , in-hospital mortality , and one-year mortality also were statistically insignificant between the groups with P values of .93 , .29 , and .33 , respectively .
RESULTS	None of the patients in either group showed evidence of limb ischemia and neurapraxia of the right upper limb .
CONCLUSIONS	RIPC is a safe technique , but it does not have additional clinical benefit after on-pump CABG surgery in the presence of a standard myocardial protective strategy .

###24666361
BACKGROUND	Topical tretinoin is commonly prescribed , but its frequent adverse effects are barriers to use .
BACKGROUND	Predictors of resistance or susceptibility to retinoid irritation are not known .
OBJECTIVE	To identify baseline patient characteristics associated with adverse effects of topical tretinoin .
METHODS	This cohort study used data collected from 324 participants in the Veterans Affairs Topical Tretinoin Chemoprevention trial who were randomized to apply tretinoin cream on the face and ears .
METHODS	Univariate and multivariate logistic regression models were used to examine the associations between baseline characteristics and local adverse effects .
RESULTS	One hundred and ninety-seven patients ( 61 % of those randomized to tretinoin ) reported local adverse effects within 6 months .
RESULTS	Clinical signs of severe photodamage at baseline [ odds ratio ( OR ) 015 , 95 % confidence interval ( CI ) 004-054 ] and history of acne ( OR 046 , 95 % CI 027-077 ) were associated with a decreased risk of adverse effects to tretinoin .
RESULTS	The use of other topical medications at enrolment ( OR 188 , 95 % CI 115-308 ) predicted an increase in adverse effects .
CONCLUSIONS	In this study population , the common indications of topical tretinoin treatment were associated with lower risks of adverse effects .
CONCLUSIONS	The concurrent use of other topical medications may worsen irritation caused by tretinoin .

###24447085
BACKGROUND	Between 75000 and 125000 U.S. infants are hospitalized for respiratory syncytial virus ( RSV ) bronchiolitis every year .
BACKGROUND	Up to half will be diagnosed with asthma in later childhood .
BACKGROUND	Vitamin D deficiency has been associated with susceptibility to asthma and respiratory infections .
BACKGROUND	Measured vitamin D is largely bound to vitamin D-binding protein ( VDBP ) ; VDBP levels are influenced by its gene ( GC ) haplotype .
OBJECTIVE	We assessed the relationship between polymorphisms rs7041 and rs4588 , which define haplotypes GC1s , GC1f , and GC2 , and RSV bronchiolitis susceptibility and subsequent asthma .
METHODS	We retrospectively recruited 198 otherwise healthy children ( 93 % White ) hospitalized for severe RSV bronchiolitis in Boston and 333 parents into a follow-up study to assess asthma diagnosis .
METHODS	Data were analysed using family-based genetic association tests .
METHODS	We independently validated our results in 465 White children hospitalized with RSV bronchiolitis and 930 White population controls from the Netherlands .
RESULTS	The rs7041_C allele ( denoting haplotype GC1s ) was overtransmitted ( P = 0.02 , additive model ) in the entire Boston cohort , in Whites ( P = 0.03 ) , and especially in children subsequently diagnosed with asthma ( P = 0.006 ) .
RESULTS	The GC1f haplotype was undertransmitted in the asthma subgroups ( all races and White , both P < 0.05 ) .
RESULTS	The rs7041_C allele was also more frequent in the RSV bronchiolitis group compared with controls ( OR 1.12 , 95 % CI 1.02 , 1.4 , P = 0.03 ) in the Netherlands , especially in mechanically ventilated patients ( P = 0.009 ) .
CONCLUSIONS	GC1s haplotype carriage may increase the risk of RSV bronchiolitis in infancy and subsequent asthma development .
CONCLUSIONS	The GC1s haplotype is associated with higher VDBP levels , resulting in less freely available vitamin D.
CONCLUSIONS	Vitamin D-binding protein ( VDBP ) haplotypes influence free vitamin D levels .
CONCLUSIONS	We report an association between a VDBP haplotype and hospitalization for RSV bronchiolitis in infancy in two independent cohorts .

###25885432
BACKGROUND	Psycho-educational interventions for people diagnosed with schizophrenia ( PDwS ) and their primary caregivers appear promising , however , the majority of trials have significant methodological shortcomings .
BACKGROUND	There is little known about the effects of these interventions delivered in a booklet format in resource-poor countries .
METHODS	A randomized controlled trial was conducted from September , 2012 to July , 2013 with 121 dyads of PDwS and their primary caregivers .
METHODS	Participants aged 18 years or older with DSM-IV schizophrenia or schizoaffective disorder , and their primary caregivers , from four outpatient mental health clinics in Jordan , were randomly assigned to receive 12 weeks of a booklet form of psycho-education , with follow-up phone calls , and treatment as usual [ TAU ] ( intervention , n = 58 ) , or TAU ( control , n = 63 ) .
METHODS	Participants were assessed at baseline , immediately post-intervention ( post-treatment1 ) and at three months follow-up .
METHODS	The primary outcome measure was change in knowledge of schizophrenia .
METHODS	Secondary outcomes for PDwS were psychiatric symptoms and relapse rate , with hospitalization or medication ( number of episodes of increasing antipsychotic dosage ) , and for primary caregivers were burden of care and quality of life .
RESULTS	PDwS in the intervention group experienced greater improvement in knowledge scores ( 4.9 vs -0.5 ; p < 0.001 ) at post-treatment and ( 6.5 vs -0.7 ; p < 0.001 ) at three month-follow-up , greater reduction in symptom severity ( -26.1 vs 2.5 ; p < 0.001 : -36.2 vs -4.9 ; p < 0.001 , at follow-up times respectively .
RESULTS	Relapse rate with hospitalization was reduced significantly at both follow-up times in the intervention group ( p < 0.001 ) , and relapse with medication increased in the intervention group at both follow-up times ( p < 0.001 ) .
RESULTS	Similarly there was a significant improvement in the primary caregivers knowledge score at post-treatment ( 6.3 vs -0.4 ; P < 0.001 ) and three month-follow-up ( 7.3 vs -0.7 ; p < 0.001 ) .
RESULTS	Primary caregivers burden of care was significantly reduced in the intervention group ( -6.4 vs 1.5 ; p < 0.001 ; -9.4 vs 0.8 ; p < 0.001 ) , and their quality of life improved ( 9.2 vs -1.6 ; p = 0.01 ; 17.1 vs -5.3 ; p < 0.001 ) at post-treatment and three month-follow-up .
CONCLUSIONS	Psycho-education and TAU was more effective than TAU alone at improving participants ' knowledge and psychological outcomes .
BACKGROUND	Current Controlled Trials ISRCTN78084871 .

###25068560
OBJECTIVE	The purpose of this study was to evaluate the efficacy of osteopathic manipulative treatment ( OMT ) to reduce low back pain and improve functioning during the third trimester in pregnancy and to improve selected outcomes of labor and delivery .
METHODS	Pregnancy research on osteopathic manipulation optimizing treatment effects was a randomized , placebo-controlled trial of 400 women in their third trimester .
METHODS	Women were assigned randomly to usual care only ( UCO ) , usual care plus OMT ( OMT ) , or usual care plus placebo ultrasound treatment ( PUT ) .
METHODS	The study included 7 treatments over 9 weeks .
METHODS	The OMT protocol included specific techniques that were administered by board-certified OMT specialists .
METHODS	Outcomes were assessed with the use of self-report measures for pain and back-related functioning and medical records for delivery outcomes .
RESULTS	There were 136 women in the OMT group : 131 women in the PUT group and 133 women in the UCO group .
RESULTS	Characteristics at baseline were similar across groups .
RESULTS	Findings indicate significant treatment effects for pain and back-related functioning ( P < .001 for both groups ) , with outcomes for the OMT group similar to that of the PUT group ; however , both groups were significantly improved compared with the UCO group .
RESULTS	For secondary outcome of meconium-stained amniotic fluid , there were no differences among the groups .
CONCLUSIONS	OMT was effective for mitigating pain and functional deterioration compared with UCO ; however , OMT did not differ significantly from PUT .
CONCLUSIONS	This may be attributed to PUT being a more active treatment than intended .
CONCLUSIONS	There was no higher likelihood of conversion to high-risk status based on treatment group .
CONCLUSIONS	Therefore , OMT is a safe , effective adjunctive modality to improve pain and functioning during the third trimester .

###25146732
BACKGROUND	Atrial fibrillation ( AF ) is the most common sustained cardiac arrhythmia imposing substantial morbidity and mortality .
BACKGROUND	Catheter-based pulmonary vein isolation ( PVI ) using radiofrequency current ( RFC ) has become a standard treatment for drug-resistant and symptomatic paroxysmal AF ( PAF ) .
BACKGROUND	In recent years , the cryoballoon-based technique is increasingly used as a promising alternative with a short learning curve .
METHODS	The FIRE AND ICE trial is a prospective , randomized , controlled , open , blinded outcome assessment , noninferiority trial comparing cryoballoon - , and RFC-based PVI .
METHODS	Patients with drug-resistant PAF will be randomized in a 1:1 matrix in multiple European centers .
METHODS	The primary hypothesis is that cryoballoon ablation is not inferior to RFC ablation using 3-dimensional mapping with respect to clinical efficacy .
METHODS	The primary endpoint is defined as the time to first documented clinical failure , including : ( 1 ) recurrence of AF ; ( 2 ) atrial flutter or atrial tachycardia ; ( 3 ) prescription of class I or III antiarrhythmic drugs ; or ( 4 ) re-ablation , whichever comes first , following a blanking period of 3 months after the index ablation procedure .
METHODS	The primary safety endpoint is a composite of death , stroke/transient ischemic attack , cardiac arrhythmias ( apart from AF recurrence ) causally related to the therapeutic intervention , and procedure-related serious adverse events .
CONCLUSIONS	The FIRE AND ICE trial compares 2 different technologies to perform catheter ablation of PAF with respect to efficacy and safety .
CONCLUSIONS	It aims at providing objective data to guide selection and usage of ablation catheters in the treatment of AF .

###25367310
OBJECTIVE	As pulmonary arterial hypertension ( PAH ) is associated with significant morbidity and mortality , particularly among patients with right ventricular ( RV ) dysfunction , we aimed to determine the impact of therapy to reduce pulmonary vascular resistance ( PVR ) on RV and LV deformation in PAH .
RESULTS	Right ventricular free wall longitudinal strain ( FWLS ) and LV global circumferential strain ( CS ) were measured at baseline , 12 weeks , and 24 weeks in 68 patients with advanced PAH randomized to imatinib or placebo in the Imatinib in Pulmonary arterial hypertension , a Randomized Efficacy Study ( IMPRES ) trial , and compared with 30 healthy controls .
RESULTS	Compared with controls , PAH was associated with impaired RV FWLS ( -15.95.4 vs. -30.84.3 , respectively ; P < 0.0001 ) and LV septal CS ( -24.28.2 vs. -31.45.3 , respectively , P < 0.0001 ) , but not LV global CS .
RESULTS	Improvement in PVR and mean pulmonary artery pressure ( MPAP ) over a 24-week period was significantly associated with improvement in RV FWLS ( r = 0.39 , P = 0.02 ; 0.33 , P = 0.04 respectively ) , LV global CS ( r = 0.61 , P = 0.0001 ; r = 0.60 , P = 0.0001 , respectively ) , and LV septal CS ( r = 0.50 , P = 0.005 ; r = 0.56 , P = 0.002 , respectively ) .
RESULTS	These associations were most robust with LV global and septal CS .
RESULTS	Imatinib therapy was associated with improvement in RV FWLS compared with placebo .
CONCLUSIONS	PAH is associated with impaired biventricular deformation .
CONCLUSIONS	Reduction in PVR is associated with improvements in both RV and LV deformation , coupled to improvements in MPAP and stroke volume index , with LV global and septal CS the strongest correlates of these changes .
CONCLUSIONS	RV FWLS is sensitive to treatment effect , demonstrating greater improvement with imatinib compared with placebo .
BACKGROUND	NCT00902174 .

###25472825
OBJECTIVE	The aim of the study was to test the antiviral efficacy of a triple nucleoside reverse transcriptase inhibitor ( NRTI ) regimen , with potential beneficial metabolic effects , as maintenance therapy after induction with dual NRTIs and a boosted protease inhibitor ( PI ) .
METHODS	An open-label , noninferiority study was carried out .
METHODS	Antiretroviral therapy ( ART ) - nave patients with CD4 count 350 cells/L and HIV-1 RNA > 30000 copies/mL ( n = 207 ) were treated with zidovudine/lamivudine and lopinavir/ritonavir .
METHODS	After achieving HIV-1 RNA < 50 copies/mL on two consecutive occasions between weeks 12 and 24 after baseline , 120 patients ( baseline : median HIV-1 RNA 5.19 log10 copies/mL ; median CD4 count 180 cells/L ) were randomized to receive abacavir/lamivudine/zidovudine ( ABC/3TC/ZDV ) ( n = 61 ) or to continue the PI-based ART ( n = 59 ) .
RESULTS	For the proportions of patients ( intention-to-treat ; missing = failure ) with HIV-1 RNA < 400 copies/mL ( PI group , 66 % ; ABC/3TC/ZDV group , 71 % ) and < 50 copies/mL ( PI group , 63 % ; ABC/3TC/ZDV group , 62 % ) at 96 weeks , switching to ABC/3TC/ZDV was noninferior compared with continuing the PI regimen ; the difference in failure rate ( ABC/3TC/ZDV minus PI ) was -4.4 percentage points [ 95 % confidence interval ( CI ) -21.0 to +12.3 percentage points ] and +0.4 percentage points ( 95 % CI -16.9 to +17.7 percentage points ) , respectively .
RESULTS	In the per protocol analysis , the difference in virological failure for HIV-1 RNA > 400 copies/mL ( 0 of 39 patients in the PI group and two of 45 patients in the NRTI group ) and for HIV-1 RNA > 50 copies/mL ( two of 39 and three of 45 patients , respectively ) was +4.4 percentage points ( 95 % CI -2.1 to +11.0 percentage points ) and +1.5 percentage points ( 95 % CI -8.6 to +11.7 percentage points ) , respectively , also showing noninferiority .
RESULTS	Serum lipids significantly improved in the NRTI group , but not in the PI arm .
CONCLUSIONS	A single-class NRTI regimen after successful induction with standard ART had similar antiviral efficacy compared to continuation of a PI-based regimen at 96 weeks after baseline , with improved serum lipids .

###24685414
BACKGROUND	Multi drug resistant-tuberculosis ( MDR-TB ) [ resistant to Isoniazid and Rifampicin ] is a major global public health problem .
BACKGROUND	In India the incidence is rising in spite of implementation of Revised National Tuberculosis Control Program .
BACKGROUND	Standard MDR-TB drugs are second generation antibiotics taken for 24-27 months .
BACKGROUND	The present study was undertaken to evaluate the efficacy of add on homeopathic intervention to the standard MDR-TB regimen ( SR ) .
METHODS	A randomized , double blind , placebo controlled study was conducted from 2003 to 2008.120 diagnosed MDR-TB patients ( both culture positive and negative ) were enrolled and randomized to receive Standard Regimen + individualized homeopathic medicine ( SR+H ) or Standard Regimen + identical placebo ( SR+P ) .
METHODS	The medicines have been used in infrequent doses .
METHODS	The outcome measures were sputum conversion , changes in chest X-ray ( CXR ) , hemoglobin , erythrocyte sedimentation rate ( ESR ) , weight gain , and clinical improvement .
RESULTS	There was an improvement in all the outcome measures as per intention to treat ( ITT ) and per protocol ( PP ) analyses .
RESULTS	ITT analyses revealed sputum culture conversion from positive to negative in 23 ( 38.3 % ) in SR+H ; 23 ( 38.3 % ) patients in SR+P group ; ( p = 0.269 ) and 27 ( 55.1 ) ; 21 ( 42.8 % ) , p = 0.225 as PP analyses .
RESULTS	The mean weight gain in SR+H group was 2.44.9 and in SR+P was 0.84.4 ; [ p = 0.071 ] , reduction in ESR in SR+H was -8.713.2 ; SR+P was 3.915.4 [ p = 0.068 ] .
RESULTS	The mean increase in hemoglobin was by 0.61.7 in SR+H & 0.32.3 [ p = 0.440 ] in SR+P group at 95 % confidence interval .
RESULTS	Statistically significant improvement was seen in CXR in 37 ( 61.7 % ) in SR+H and 20 ( 33.3 % ) patients in SR+P group ( p = 0.002 ) .
RESULTS	Subgroup analyses of culture positive patients showed statistically significant improvement in CXR ( p = 0.0005 ) , weight gain ( p = 0.026 ) , increase in hemoglobin ( p = 0.017 ) and reduction in ESR ( p = 0.025 ) with add on homeopathy .
RESULTS	The cure rate was 11.4 % more in SR+H group as compared to placebo group .
RESULTS	Change in sputum culture conversion , was not statistically significant .
CONCLUSIONS	Add on homeopathy in addition to standard therapy appears to improve outcome in MDR-TB .
CONCLUSIONS	Larger scale studies using a standardized homeopathic treatment regime should be conducted .

###25456333
BACKGROUND	In youth , both waterpipe tobacco smoking ( WTS ) and nonmedical use of prescription drugs ( NMUPD ) are globally growing concerns .
BACKGROUND	This study assesses for the first time the lifetime and past-year associations between WTS and four classes of psychoactive prescription drugs .
METHODS	Cross-sectional data ( 2011 ) on 986 high school students attending public and private high schools in Beirut ( Lebanon ) was analyzed .
METHODS	Schools were selected using proportionate random cluster sampling from a comprehensive list of schools provided by the Ministry of Education .
RESULTS	Almost half ( 46 % ) had tried WTS compared to 25 % who had ever tried cigarettes .
RESULTS	Lifetime prevalence estimates of NMUPD were : pain relievers ( 8.2 % ) , sedatives/tranquilizers ( 5.6 % ) , stimulants ( 3.5 % ) , antidepressants ( 2.5 % ) , and sleeping pills ( 2.3 % ) .
RESULTS	WTS was associated with increased odds of sedatives/tranquilizer use ( OR = 3.22 , 95 % CI : 1.25 , 8.25 ) , pain reliever use ( OR = 4.31 , 95 % CI : 2.02 , 9.17 ) , and sleeping medication use ( OR = 8.31 , 95 % CI : 2.37 , 29.20 ) , controlling for sex , age , school type , and other substance use .
RESULTS	For cigarettes , the associations were consistently either weaker or non-existent , except with stimulant use ( OR = 5.29 , 95 % CI : 1.55 , 18.05 ) .
CONCLUSIONS	While public health professionals have watched with caution the global prevalence of youth cigarette use-worldwide , an insidious alternative form of tobacco use has grown .
CONCLUSIONS	Further research is needed to understand the unique risk factors and motives associated with WTS and how these relate to NMUPD in order to inform the development of effective intervention programs and policies that support youth positive health decisions .

###25127244
BACKGROUND	Vaccine effectiveness of pneumococcal conjugate vaccines against culture-confirmed invasive pneumococcal disease has been well documented .
BACKGROUND	In the Finnish Invasive Pneumococcal disease ( FinIP ) trial , we reported vaccine effectiveness and absolute rate reduction against laboratory-confirmed invasive pneumococcal disease ( confirmation by culture or antigen or DNA detection irrespective of serotype ) .
BACKGROUND	Here , we assessed vaccine effectiveness of PHiD-CV10 against clinically suspected invasive pneumococcal disease in children by use of diagnoses coded in hospital discharge registers .
METHODS	For this phase 3/4 cluster-randomised , double-blind trial , undertaken between Feb 18 , 2009 , and Dec 31 , 2011 , in municipal health-care centres and the Tampere University Vaccine Research Centre ( Finland ) , we randomly assigned ( 2:2:1:1 ) 78 clusters into PHiD-CV10 three plus one , PHiD-CV10 two plus one , control three plus one , control two plus one groups ( 26:26:13:13 clusters ) to give PHiD-CV10 in either three plus one or two plus one schedule ( if enrolled before 7 months of age ; infant schedules ) , two plus one ( if enrolled between 7 and 11 months ; catch-up schedules ) , and two doses at least 6 months apart ( if enrolled between 12 and 18 months ; catch-up schedules ) .
METHODS	Children were eligible if they had not received and were not anticipated to receive any of the study vaccines and had no general contraindications to vaccinations .
METHODS	We collected all inpatient and outpatient discharge notifications from the national hospital discharge register with International Classification of Diseases ( ICD ) 10 diagnoses compatible with invasive pneumococcal disease or unspecified sepsis , and verified data with patient files .
METHODS	We excluded invasive pneumococcal disease cases confirmed by positive culture or DNA/RNA detection from normally sterile body fluid .
METHODS	The primary objective was to estimate vaccine effectiveness against all register-based non-laboratory-confirmed invasive pneumococcal disease or unspecified sepsis and patient-file verified non-laboratory-confirmed invasive pneumococcal disease in infants younger than 7 months at enrolment .
METHODS	Masked follow-up lasted from the date of the first vaccination to Dec 31 , 2011 .
METHODS	Vaccine effectiveness was calculated against all episodes .
METHODS	This trial is registered with ClinicalTrials.gov , numbers NCT00861380 and NCT00839254 .
RESULTS	We enrolled 47,366 children .
RESULTS	On the basis of ICD-10 diagnoses , we recorded 264 episodes of register-based non-laboratory-confirmed invasive pneumococcal disease or unspecified sepsis , of which 102 were patient-file verified non-laboratory-confirmed invasive pneumococcal disease .
RESULTS	The vaccine effectiveness was 50 % ( 95 % CI 32-63 ) in the 30,527 infants with three plus one and two plus one schedules combined and the absolute incidence rate reduction was 207 episodes per 100,000 person-years ( 95 % CI 127-286 ) .
RESULTS	The vaccine effectiveness against the patient-file verified non-laboratory-confirmed invasive pneumococcal disease was 71 % ( 95 % CI 52-83 ) in infant three plus one and two plus one schedules combined .
RESULTS	The absolute rate reduction was 142 episodes per 100,000 person-years ( 95 % CI 91-191 ) in infant cohorts .
CONCLUSIONS	This vaccine-probe analysis is the first report showing the effect of pneumococcal conjugate vaccines on clinically suspected invasive pneumococcal disease .
CONCLUSIONS	The absolute rate reduction was markedly higher compared with laboratory-confirmed invasive pneumococcal disease , which implies low sensitivity of the laboratory-based case definitions and subsequently higher public health effect of pneumococcal conjugate vaccines against invasive pneumococcal disease than previously estimated .
BACKGROUND	GlaxoSmithKline Biologicals SA and National Institute for Health and Welfare ( THL ) , Finland .

###24395985
BACKGROUND	Communication problems impede effective symptom management during chemotherapy .
BACKGROUND	The primary aim of this pilot randomized controlled trial was to test the effects of a personal digital assistant-delivered communication intervention on pain , depression , and fatigue symptoms among breast cancer patients undergoing chemotherapy .
BACKGROUND	Secondary aims included assessment of 1 ) study feasibility , 2 ) patient and clinician responses to study participation , and 3 ) intervention effects on health-related quality of life ( HRQoL ) and communication self-efficacy .
METHODS	Intervention group participants ( n = 27 ) completed symptom inventories at baseline , once per week during treatment , and at posttreatment .
METHODS	Depending on symptom severity , they viewed race-concordant videos on how to communicate about pain , depression and/or fatigue , using the personal digital assistant .
METHODS	Symptom records were tracked and shared with clinicians .
METHODS	Control group participants ( n = 23 ) received usual care .
METHODS	Longitudinal random effects modeling assessed the changes in average symptom scores over time .
METHODS	Descriptive statistics assessed study feasibility and intervention effects on HRQoL and communication self-efficacy .
METHODS	Postintervention focus groups , interviews , and surveys assessed responses to study participation .
RESULTS	Mean age of the participants was 51.0 years ; 42 participants ( 84 % ) were white .
RESULTS	In comparison with control , intervention group participants reported lower average pain severity over time ( P = .015 ) .
RESULTS	Mean pain interference scores over time were marginally different between groups ( P = .07 ) ; mean depression and fatigue scores over time were statistically nonsignificant .
RESULTS	Feasibility outcomes and perspectives about study participation were positive .
RESULTS	Mean pre-post decreases in HRQoL were generally higher among intervention group participants ; pre-post changes in communication self-efficacy were equivalent .
CONCLUSIONS	Mixed findings of the study indicate the need for future research .

###25417892
BACKGROUND	The resynchronization-defibrillation for ambulatory heart failure trial ( RAFT ) study demonstrated that adding cardiac resynchronization therapy ( CRT ) in selected patients requiring de novo implantable cardiac defibrillators ( ICD ) reduced mortality as compared with ICD therapy alone , despite an increase in procedure-related adverse events .
BACKGROUND	Data are lacking regarding the management of patients with ICD therapy who develop an indication for CRT upgrade .
RESULTS	Participating RAFT centers provided data regarding de novo CRT-D ( CRT with ICD ) implant , upgrade to CRT-D during RAFT ( study upgrade ) , and upgrade within 6 months after presentation of study results ( substudy ) .
RESULTS	Substudy centers enrolled 1346 ( 74.9 % ) patients in RAFT , including 644 de novo , 80 study upgrade , and 60 substudy CRT attempts .
RESULTS	The success rate ( initial plus repeat attempts ) was 95.2 % for de novo versus 96.3 % for study upgrade and 90.0 % for substudy CRT attempts ( P = 0.402 ) .
RESULTS	Acute complications occurred among 26.2 % of de novo versus 18.8 % of study upgrade and 3.4 % of substudy CRT implantation attempts ( P < 0.001 ) .
RESULTS	The most common complication was left ventricular lead dislodgement .
RESULTS	The principal reasons for not yet attempting upgrade in the substudy were patient preference ( 31.9 % ) , New York Heart Association Class I ( 17.0 % ) , and a QRS < 150 ms ( 13.1 % ) .
CONCLUSIONS	Among a broad group of implant physicians , CRT upgrades were performed in patients with an ICD in situ with no difference in implant success rate and a reduced acute complication rate as compared with a de novo CRT implant .
CONCLUSIONS	Decisions to upgrade were influenced by predictors of benefit in subgroup analyses of the RAFT study and other trials .

###24832476
OBJECTIVE	Military deployment can have profound effects on physical and mental health .
OBJECTIVE	Few studies have examined whether interventions prior to deployment can improve mechanisms underlying resilience .
OBJECTIVE	Mindfulness-based techniques have been shown to aid recovery from stress and may affect brain-behavior relationships prior to deployment .
OBJECTIVE	The authors examined the effect of mindfulness training on resilience mechanisms in active-duty Marines preparing for deployment .
METHODS	Eight Marine infantry platoons ( N = 281 ) were randomly selected .
METHODS	Four platoons were assigned to receive mindfulness training ( N = 147 ) and four were assigned to a training-as-usual control condition ( N = 134 ) .
METHODS	Platoons were assessed at baseline , 8 weeks after baseline , and during and after a stressful combat training session approximately 9 weeks after baseline .
METHODS	The mindfulness training condition was delivered in the form of 8 weeks of Mindfulness-Based Mind Fitness Training ( MMFT ) , a program comprising 20 hours of classroom instruction plus daily homework exercises .
METHODS	MMFT emphasizes interoceptive awareness , attentional control , and tolerance of present-moment experiences .
METHODS	The main outcome measures were heart rate , breathing rate , plasma neuropeptide Y concentration , score on the Response to Stressful Experiences Scale , and brain activation as measured by functional MRI .
RESULTS	Marines who received MMFT showed greater reactivity ( heart rate [ d = 0.43 ] ) and enhanced recovery ( heart rate [ d = 0.67 ] , breathing rate [ d = 0.93 ] ) after stressful training ; lower plasma neuropeptide Y concentration after stressful training ( d = 0.38 ) ; and attenuated blood-oxygen-level-dependent signal in the right insula and anterior cingulate .
CONCLUSIONS	The results show that mechanisms related to stress recovery can be modified in healthy individuals prior to stress exposure , with important implications for evidence-based mental health research and treatment .

###25377015
BACKGROUND	Malignant pleural effusion can complicate most cancers .
BACKGROUND	It causes breathlessness and requires hospitalisation for invasive pleural drainages .
BACKGROUND	Malignant effusions often herald advanced cancers and limited prognosis .
BACKGROUND	Minimising time spent in hospital is of high priority to patients and their families .
BACKGROUND	Various treatment strategies exist for the management of malignant effusions , though there is no consensus governing the best choice .
BACKGROUND	Talc pleurodesis is the conventional management but requires hospitalisation ( and substantial healthcare resources ) , can cause significant side effects , and has a suboptimal success rate .
BACKGROUND	Indwelling pleural catheters ( IPCs ) allow ambulatory fluid drainage without hospitalisation , and are increasingly employed for management of malignant effusions .
BACKGROUND	Previous studies have only investigated the length of hospital care immediately related to IPC insertion .
BACKGROUND	Whether IPC management reduces time spent in hospital in the patients ' remaining lifespan is unknown .
BACKGROUND	A strategy of malignant effusion management that reduces hospital admission days will allow patients to spend more time outside hospital , reduce costs and save healthcare resources .
METHODS	The Australasian Malignant Pleural Effusion ( AMPLE ) trial is a multicentred , randomised trial designed to compare IPC with talc pleurodesis for the management of malignant pleural effusion .
METHODS	This study will randomise 146 adults with malignant pleural effusions ( 1:1 ) to IPC management or talc slurry pleurodesis .
METHODS	The primary end point is the total number of days spent in hospital ( for any admissions ) from treatment procedure to death or end of study follow-up .
METHODS	Secondary end points include hospital days specific to pleural effusion management , adverse events , self-reported symptom and quality-of-life scores .
BACKGROUND	The Sir Charles Gairdner Group Human Research Ethics Committee has approved the study as have the ethics boards of all the participating hospitals .
BACKGROUND	The trial results will be published in peer-reviewed journals and presented at scientific conferences .
BACKGROUND	Australia New Zealand Clinical Trials Registry-ACTRN12611000567921 ; National Institutes of Health-NCT02045121 .

###24576855
BACKGROUND	The pulsatile secretion pattern of growth hormone ( GH ) is an important parameter of GH action at peripheral tissues , and more information is needed on how exercise impacts GH secretion .
BACKGROUND	This study hypothesized that both aerobic and resistance exercise would exhibit dose-response relationships with respect to exercise duration and 20-h postexercise GH secretion .
METHODS	Eight healthy men randomly completed five separate conditions : 1 ) control ( no exercise ; CON ) , 2 ) a moderate-duration ( 1-h ) aerobic exercise session ( MA ) , 3 ) a long-duration ( 2-h ) aerobic exercise session ( LA ) , 4 ) a moderate-duration ( 1-h ) resistance exercise session ( MR ) , and 5 ) a long-duration ( 2-h ) resistance exercise session ( LR ) .
METHODS	Exercise intensity , diet , sleep , and physical activity were strictly controlled during each condition , and blood was sampled postexercise every 20 min for 20 h , and GH secretion parameters were analyzed via cluster and deconvolution analyses .
RESULTS	Only the 2-h aerobic exercise bout resulted in a significant amplification of GH secretion as evidenced by increases in GH burst peak amplitude ( 100 % ) , basal GH secretion rate ( 127 % ) , total GH basal secretion ( 120 % ) , total pulsatile secretion ( 88 % ) , and total GH secretion ( 89 % ) over the control ( i.e. , no exercise ) condition .
RESULTS	GH secretions for the resistance exercise conditions were not different from control .
CONCLUSIONS	The fact that the 2-h aerobic exercise condition resulted in higher energy expenditure than the other exercise conditions could offer a partial explanation for the greater GH amplification because of the metabolic effects that GH exerts in stimulating postexercise lipolysis .
CONCLUSIONS	We conclude that extending the duration of aerobic exercise , but not resistance exercise , from 1 - to 2-h significantly amplifies GH secretion during a 20-h period .

###24796199
OBJECTIVE	To compare the effective of short-segment pedicle instrumentation with bone grafting and pedicle screw implanting in injured vertebra and cross segment pedicle instrumentation with bone grafting in injured vertebra for treating thoracolumbar fractures .
METHODS	A prospective randomized controlled study was performed in 40 patients with thoracolumbar fracture who were in accordance with the inclusive criteria between June 2010 and June 2012 .
METHODS	Of 40 patients , 20 received treatment with short-segment pedicle screw instrumentation with bone grafting and pedicle screw implanting in injured vertebra in group A , and 20 received treatment with cross segment pedicle instrumentation with bone grafting in injured vertebra in group B.
METHODS	There was no significant difference in gender , age , affected segment , disease duration , Frankel grade , Cobb angle , compression rate of anterior verterbral height , visual analogue scale ( VAS ) score , and Japanese Orthopaedic Association ( JOA ) score between 2 groups before operation ( P > 0.05 ) .
METHODS	The operation time , blood loss , Cobb angle , compression rate of anterior vertebral height , loss of disc space height , Frankel grade , VAS and JOA scores were compared between 2 groups .
RESULTS	There was no significant difference in the operation time and blood loss between 2 groups ( P > 0.05 ) .
RESULTS	Primary healing of incision was obtained in all patients , and no early complication of infection or lower limb vein thrombus occurred .
RESULTS	Forty patients were followed up 12-16 months ( mean , 14.8 months ) .
RESULTS	No breaking or displacement of internal fixation was observed .
RESULTS	The improvement of Frankel grading score was 0.52 + / - 0.72 in group A and 0.47 + / - 0.63 in group B , showing no significant difference ( t = 0.188 , P = 0.853 ) at 12 months after operation .
RESULTS	The Cobb angle , compression rate of anterior verterbral height , and VAS score at 1 week and 12 months , and JOA score at 12 months were significantly improved when compared with preoperative ones in 2 groups ( P < 0.05 ) .
RESULTS	No significant difference was found in Cobb angle , disc space height , VAS score , and JOA score between 2 groups at each time point ( P > 0.05 ) , but the compression rate of anterior verterbral height in group A was significantly lower than that in group B ( P < 0.05 ) .
RESULTS	The loss of disc space height next to the internal fixation or the injured vertebra was observed in 2 groups at 12 months , but showing no significant difference ( P > 0.05 ) .
CONCLUSIONS	Compared with cross segment pedicle instrumentation , short-segment pedicle screw instrumentation with bone grafting and pedicle screw implanting in injured vertebra can recover and maintain the affected vertebra height in treating thoracolumbar fractures , but it could not effectively prevent degeneration of adjacent segments and the loss of kyphosis correction degree .

###25542677
OBJECTIVE	To evaluate the effect of a novel divided attention task-walking under auditory constraints-on gait performance in older adults and to determine whether this effect was moderated by cognitive status .
METHODS	Validation cohort .
METHODS	General community .
METHODS	Ambulatory older adults without dementia ( N = 104 ) .
METHODS	Not applicable .
METHODS	In this pilot study , we evaluated walking under auditory constraints in 104 older adults who completed 3 pairs of walking trials on a gait mat under 1 of 3 randomly assigned conditions : 1 pair without auditory stimulation and 2 pairs with emotionally charged auditory stimulation with happy or sad sounds .
RESULTS	The mean age of subjects was 80.64.9 years , and 63 % ( n = 66 ) were women .
RESULTS	The mean velocity during normal walking was 97.920.6 cm/s , and the mean cadence was 105.19.9 steps/min .
RESULTS	The effect of walking under auditory constraints on gait characteristics was analyzed using a 2-factorial analysis of variance with a 1-between factor ( cognitively intact and minimal cognitive impairment groups ) and a 1-within factor ( type of auditory stimuli ) .
RESULTS	In both happy and sad auditory stimulation trials , cognitively intact older adults ( n = 96 ) showed an average increase of 2.68 cm/s in gait velocity ( F1 .86,191.71 = 3.99 ; P = .02 ) and an average increase of 2.41 steps/min in cadence ( F1 .75,180.42 = 10.12 ; P < .001 ) as compared with trials without auditory stimulation .
RESULTS	In contrast , older adults with minimal cognitive impairment ( Blessed test score , 5-10 ; n = 8 ) showed an average reduction of 5.45 cm/s in gait velocity ( F1 .87,190.83 = 5.62 ; P = .005 ) and an average reduction of 3.88 steps/min in cadence ( F1 .79,183.10 = 8.21 ; P = .001 ) under both auditory stimulation conditions .
RESULTS	Neither baseline fall history nor performance of activities of daily living accounted for these differences .
CONCLUSIONS	Our results provide preliminary evidence of the differentiating effect of emotionally charged auditory stimuli on gait performance in older individuals with minimal cognitive impairment compared with those without minimal cognitive impairment .
CONCLUSIONS	A divided attention task using emotionally charged auditory stimuli might be able to elicit compensatory improvement in gait performance in cognitively intact older individuals , but lead to decompensation in those with minimal cognitive impairment .
CONCLUSIONS	Further investigation is needed to compare gait performance under this task to gait on other dual-task paradigms and to separately examine the effect of physiological aging versus cognitive impairment on gait during walking under auditory constraints .

###25273653
OBJECTIVE	To investigate the better method of digestive tract reconstruction in proximal gastrectomy for early gastroesophageal junction adenocarcinoma .
METHODS	A total of 153 cases of early gastroesophageal junction adenocarcinoma who were planned to receive radical proximal gastrectomy from January 2003 to December 2011 were prospectively enrolled and randomly divided into two groups by table of random number according to methods of digestive tract reconstruction , including 3S anastomosis group ( 80 cases , 3S jejunal interposition ) and traditional anastomosis group ( 73 cases , esophageal remnant gastric posterior wall anastomosis ) .
METHODS	Postoperative complications , operative time , mortality , nutritional parameters and postoperative quality of life were compared between these two groups .
RESULTS	There were no significant differences between two groups in postoperative complications , operative time and mortality ( all P > 0.05 ) .
RESULTS	3S anastomosis group was better in nutritional parameters than traditional group six months after operation ( P < 0.05 ) .
RESULTS	As compared to traditional group , incidence of reflux esophagitis decreased [ 20.0 % ( 16/80 ) vs. 46.6 % ( 34/73 ) , P < 0.01 ] and gastric emptying time prolonged obviously [ ( 160.88.1 ) min vs. ( 61.110.8 ) min , P < 0.01 ] in 3S anastomosis group 18 months after operation .
RESULTS	Postoperative QLQ-C30 rating scale revealed quality of life was significantly higher in 3S anastomosis group as compared to traditional group .
CONCLUSIONS	Jejunal interposition is a better method of digestive tract reconstruction in proximal gastrectomy for early gastroesophageal junction carcinoma .

###24465387
BACKGROUND	A brief psychodynamic interpersonal therapy ( PIT ) in patients with multisomatoform disorder has been recently shown to improve health-related quality of life .
OBJECTIVE	To assess cost-effectiveness of PIT compared to enhanced medical care in patients with multisomatoform disorder .
METHODS	An economic evaluation alongside a randomised controlled trial ( International Standard Randomised Controlled Trial Number ISRCTN23215121 ) conducted in 6 German academic outpatient centres was performed .
METHODS	Incremental cost-effectiveness ratio ( ICER ) was calculated from the statutory health insurance perspective on the basis of quality adjusted life years ( QALYs ) gained at 12 months .
METHODS	Uncertainty surrounding the cost-effectiveness of PIT was presented by means of a cost-effectiveness acceptability curve .
RESULTS	Based on the complete-case analysis ICER was 41840 Euro per QALY .
RESULTS	The results did not change greatly with the use of multiple imputation ( ICER = 44222 ) and last observation carried forward ( LOCF ) approach to missing data ( ICER = 46663 ) .
RESULTS	The probability of PIT being cost-effective exceeded 50 % for thresholds of willingness to pay over 35 thousand Euros per QALY .
CONCLUSIONS	Cost-effectiveness of PIT is highly uncertain for thresholds of willingness to pay under 35 thousand Euros per QALY .

###24700631
OBJECTIVE	To analyze the effect of biological maturation on training-induced strength and endurance adaptations in the prepubertal growth spurt .
METHODS	One hundred and twenty-five healthy children ( 58 boys , 67 girls ) , aged 10-11 years old ( 10.8 0.4 years ) , who were self-assessed as belonging to Tanner stages I and II , were randomly divided into two experimental groups , a strength training group ( 19 boys , 22 girls ) and an endurance training group ( 21 boys , 24 girls ) that would train twice a week for 8 weeks , as well as a control group ( 18 boys , 21 girls ; no training program ) .
RESULTS	After 8 weeks of training , there were improvements in all strength and endurance measures ( P < 0.01 ) for both groups of Tanner stage I and II children .
RESULTS	No significant differences in training response were observed relative to biological maturity or gender ( P > 0.05 ) .
CONCLUSIONS	These data suggest that more biologically mature prepubescent children seem to have no advantage in training-induced strength and endurance adaptations compared with their less mature peers .
CONCLUSIONS	Additionally , gender did not affect the training-induced changes in strength or aerobic fitness .
CONCLUSIONS	These results are meaningful for the development of optimized well-rounded training programs in prepubertal children .
CONCLUSIONS	Am .
CONCLUSIONS	J. Hum .
CONCLUSIONS	Biol .
CONCLUSIONS	26:469 -475 , 2014.2014 Wiley Periodicals , Inc. .

###25710460
BACKGROUND	24,25-Dihydroxyvitamin D [ 24,25 ( OH ) 2D ] in serum may be both a nuisance and nutritionally valuable .
METHODS	We investigated the impact of 24,25 ( OH ) 2D3 on the performance of commercially available immunoassays for serum total 25-hydroxyvitamin D [ 25 ( OH ) D ] using ( a ) serum from a nationally representative sample of adults , ( b ) serum from a spiking experiment , and ( c ) data from the UK Vitamin D External Quality Assurance Scheme ( DEQAS ) .
METHODS	We also investigated the utility of the serum ratio of 24,25 ( OH ) 2D3 to 25 ( OH ) D as an index of inactivation and of response to vitamin D supplementation using randomized controlled trial ( RCT ) data .
METHODS	Measurement of 24,25 ( OH ) 2D in sera by a LC-MS/MS method allowed for an investigation of its impact on immunoassay-derived serum 25 ( OH ) D values as well as its clinical utility .
METHODS	We report data from a nationally representative sample of adults , a recent vitamin D RCT in older adults , and DEQAS .
RESULTS	24,25 ( OH ) 2D3 contributed to the positive bias observed in some immunoassays relative to LC-MS/MS-derived estimates for total 25 ( OH ) D.
RESULTS	A spiking experiment showed that the degree of cross-reactivity with 24,25 ( OH ) 2D was high and may underpin this positive bias .
RESULTS	Adjustment for 24,25 ( OH ) 2D3 concentration brought estimates closer to true values .
RESULTS	Data from the vitamin D RCT showed that the ratio of 24,25 ( OH ) 2D3 to 25 ( OH ) D was associated with serum 25 ( OH ) D3 and with response of serum 25 ( OH ) D to vitamin D supplementation .
CONCLUSIONS	Our findings highlight that the effect of 24,25 ( OH ) 2D3 in serum is a double-edged sword-an interferent for some immunoassays , yet potentially informative of nutritional status .

###25440791
BACKGROUND	The progressive nature of heart failure ( HF ) coupled with high mortality and poor quality of life mandates greater attention to palliative care as a routine component of advanced HF management .
BACKGROUND	Limited evidence exists from randomized , controlled trials supporting the use of interdisciplinary palliative care in HF .
METHODS	PAL-HF is a prospective , controlled , unblinded , single-center study of an interdisciplinary palliative care intervention in 200 patients with advanced HF estimated to have a high likelihood of mortality or rehospitalization in the ensuing 6 months .
METHODS	The 6-month PAL-HF intervention focuses on physical and psychosocial symptom relief , attention to spiritual concerns , and advanced care planning .
METHODS	The primary end point is health-related quality of life measured by the Kansas City Cardiomyopathy Questionnaire and the Functional Assessment of Chronic Illness Therapy with Palliative Care Subscale score at 6 months .
METHODS	Secondary end points include changes in anxiety/depression , spiritual well-being , caregiver satisfaction , cost and resource utilization , and a composite of death , HF hospitalization , and quality of life .
CONCLUSIONS	PAL-HF is a randomized , controlled clinical trial that will help evaluate the efficacy and cost effectiveness of palliative care in advanced HF using a patient-centered outcome as well as clinical and economic end points .

###25301251
BACKGROUND	There is a need to find simple cost effective weight loss interventions that can be used in primary care .
BACKGROUND	There is evidence that self-monitoring is an effective intervention for problem drinking and self-weighing might be an effective intervention for weight loss .
OBJECTIVE	To examine the efficacy of daily self-weighing as an intervention for weight loss .
METHODS	A randomised controlled trial of 183 obese adults , follow-up three months .
METHODS	The intervention group were given a set of weighing scales and instructed to weigh themselves daily and record their weight .
METHODS	Both groups received two weight loss consultations which were known to be ineffective .
RESULTS	92 participants were randomised to the intervention group and 91 to the control group .
RESULTS	The intervention group lost 0.5 kg ( 95 % CI 0.3 to 1.3 kg ) more than the control group , but this was not significant .
RESULTS	There was no evidence that self-weighing frequency was associated with more weight loss .
CONCLUSIONS	As an intervention for weight loss , instruction to weigh daily is ineffective .
CONCLUSIONS	Unlike other studies , there was no evidence that greater frequency of self-weighing is associated with greater weight loss .
BACKGROUND	ISRCTN05815264 .

###25225745
BACKGROUND	Cardiac surgery can be complicated by postoperative cognitive decline ( POCD ) , which is characterized by impaired memory function and intellectual ability .
BACKGROUND	The systemic inflammatory response that is induced by major surgery and cardiopulmonary bypass may play an important role in the etiology of POCD .
BACKGROUND	Prophylactic corticosteroids to attenuate the inflammatory response may therefore reduce the risk of POCD .
BACKGROUND	The authors investigated the effect of intraoperative high-dose dexamethasone on the incidence of POCD at 1 month and 12 months after cardiac surgery .
METHODS	This multicenter , randomized , double-blind , placebo-controlled trial is a preplanned substudy of the DExamethasone for Cardiac Surgery trial .
METHODS	A total of 291 adult patients undergoing cardiac surgery with cardiopulmonary bypass were recruited in three hospitals and randomized to receive dexamethasone 1 mg/kg ( n = 145 ) or placebo ( n = 146 ) .
METHODS	The main outcome measures were incidence of POCD at 1 - and 12-month follow-up , defined as a decline in neuropsychological test performance beyond natural variability , as measured in a control group .
RESULTS	At 1-month follow-up , 19 of 140 patients in the dexamethasone group ( 13.6 % ) and 10 of 138 patients in the placebo group ( 7.2 % ) fulfilled the diagnostic criteria for POCD ( relative risk , 1.87 ; 95 % CI , 0.90 to 3.88 ; P = 0.09 ) .
RESULTS	At 12-month follow-up , 8 of 115 patients in the dexamethasone group ( 7.0 % ) and 4 of 114 patients ( 3.5 % ) in the placebo group had POCD ( relative risk , 1.98 ; 95 % CI , 0.61 to 6.40 ; P = 0.24 ) .
CONCLUSIONS	Intraoperative high-dose dexamethasone did not reduce the risk of POCD after cardiac surgery .

###24771090
OBJECTIVE	As glycaemia and the incidence of microvascular diabetes complications follow a log-linear relationship , it becomes increasingly difficult to demonstrate a microvascular benefit of glucose-lowering when the HbA1c level is close to normal .
METHODS	The Outcome Reduction with an Initial Glargine Intervention ( ORIGIN ) trial randomised 12,537 people with diabetes , impaired glucose tolerance or impaired fasting glucose to receive standard glycaemic care or standard care with the addition of basal insulin glargine ( A21Gly , B31Arg , B32Arg human insulin ) , targeting a fasting plasma glucose level 5.3 mmol/l .
METHODS	Microvascular outcomes during a median follow-up of 6.2 years were examined in participants whose baseline HbA1c was above or below the median of 6.4 % ( 46.4 mmol/mol ) .
RESULTS	Allocation to the insulin glargine group reduced the incidence of the primary microvascular composite outcome of kidney and eye disease in participants whose baseline HbA1c level was 6.4 % ( 46.4 mmol/mol ; HR 0.90 [ 95 % CI 0.81 , 0.99 ] ) but not in participants with a lower baseline HbA1c ( HR 1.07 [ 95 % CI 0.95 , 1.20 ] ; p value for interaction 0.031 ) .
RESULTS	In people whose baseline HbA1c level was 6.4 % ( 46.4 mmol/mol ) , the median post-randomisation change in HbA1c was -0.65 % ( interquartile range -0.16 , -0.91 % ) after allocation to insulin glargine and -0.33 % ( -0.83 , 0.13 % ) after allocation to standard care ( median HbA1c difference 0.33 % ; p < 0.0001 ) .
RESULTS	A smaller median difference of 0.22 % was noted in people whose baseline HbA1c was < 6.4 % ( p < 0.0001 ) .
CONCLUSIONS	In patients with dysglycaemia , intervention targeting normal fasting glucose levels reduced HbA1c and attenuated the risk of microvascular outcomes in participants with a baseline HbA1c level 6.4 % ( 46.4 mmol/mol ) .
CONCLUSIONS	A neutral effect was seen in those with a lower baseline HbA1c level .
BACKGROUND	ClinicalTrials.gov NCT00069784 .

###24622263
BACKGROUND	Effective reduction of albuminuria and blood pressure in patients with type 2 diabetes who have nephropathy is seldom achieved with available treatments .
BACKGROUND	We tested the effects of treatment of such patients with daglutril , a combined endothelin-converting enzyme and neutral endopeptidase inhibitor .
METHODS	We did this randomised , crossover trial in two hospitals in Italy .
METHODS	Eligibility criteria were : age 18 years or older , urinary albumin excretion 20-999 g/min , systolic blood pressure ( BP ) less than 140 mm Hg , and diastolic BP less than 90 mm Hg .
METHODS	Patients were randomly assigned ( 1:1 ) with a computer-generated randomised sequence to receive either daglutril ( 300 mg/day ) then placebo for 8 weeks each or vice versa , with a 4-week washout period .
METHODS	Patients also took losartan throughout .
METHODS	Participants and investigators were masked to treatment allocation .
METHODS	The primary endpoint was 24-h urinary albumin excretion in the intention-to-treat population .
METHODS	Secondary endpoints were median office and ambulatory ( 24 h , daytime , and night-time ) BP , renal haemodynamics and sieving function , and metabolic and laboratory test results .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00160225 .
RESULTS	We screened 58 patients , of whom 45 were enrolled ( 22 assigned to daglutril then placebo , 23 to placebo then daglutril ; enrolment from May , 2005 , to December , 2006 ) and 42 ( 20 vs 22 ) were included in the primary analysis .
RESULTS	Daglutril did not significantly affect 24-h urinary albumin excretion compared with placebo ( difference in change -76 g/min , IQR -787 to 190 ; p = 0559 ) .
RESULTS	34 patients had complete 24-h BP readings ; compared with placebo , daglutril significantly reduced 24-h systolic ( difference -52 mm Hg , SD 94 ; p = 00013 ) , diastolic ( -25 , 62 ; p = 0015 ) , pulse ( -30 , 63 ; p = 0019 ) , and mean ( -31 , 62 ; p = 0003 ) BP , as well as all night-time BP readings and daytime systolic , pulse , and mean BP , but not diastolic BP .
RESULTS	Compared with placebo , daglutril also significantly reduced office systolic BP ( -54 , 154 ; p = 0028 ) , but not diastolic ( -18 , 99 ; p = 0245 ) , pulse ( -31 , 106 ; p = 0210 ) , or mean ( -21 , 104 ; p = 0205 ) BP , and increased big endothelin serum concentration .
RESULTS	Other secondary outcomes did not differ significantly between treatment periods .
RESULTS	Three patients taking placebo and six patients taking daglutril had mild treatment-related adverse events -- the most common was facial or peripheral oedema ( in four patients taking daglutril ) .
CONCLUSIONS	Daglutril improved control of BP in hypertensive patients with type 2 diabetes and nephropathy and had an acceptable safety profile .
CONCLUSIONS	Combined endothelin-converting enzyme and neutral endopeptidase inhibition could provide a new approach to hypertension in this high-risk population .
BACKGROUND	Solvay Pharmaceuticals .

###24519922
OBJECTIVE	To compare the effects of body weight-supported treadmill training and overground walking training when matched for task and dose ( duration/frequency/intensity ) on improving walking function , activity , and participation after stroke .
METHODS	Single-blind , pilot randomized controlled trial with three-month follow-up .
METHODS	University and community settings .
METHODS	A convenience sample of participants ( N = 20 ) at least six months post-stroke and able to walk independently were recruited .
METHODS	Thirty-minute walking interventions ( body weight-supported treadmill training or overground walking training ) were administered five times a week for two weeks .
METHODS	Intensity was monitored with the Borg Rating of Perceived Exertion Scale at five-minute increments to maintain a moderate training intensity .
METHODS	Walking speed ( comfortable/fast 10-meter walk ) , walking endurance ( 6-minute walk ) , spatiotemporal symmetry , and the ICF Measure of Participation and ACTivity were assessed before , immediately after , and three months following the intervention .
RESULTS	The overground walking training group demonstrated significantly greater improvements in comfortable walking speed compared with the body weight-supported treadmill training group immediately ( change of 0.11 m/s vs. 0.06 m/s , respectively ; p = 0.047 ) and three months ( change of 0.14 m/s vs. 0.08 m/s , respectively ; p = 0.029 ) after training .
RESULTS	Only the overground walking training group significantly improved comfortable walking speed ( p = 0.001 ) , aspects of gait symmetry ( p = 0.032 ) , and activity ( p = 0.003 ) immediately after training .
RESULTS	Gains were maintained at the three-month follow-up ( p < 0.05 ) for all measures except activity .
RESULTS	Improvements in participation were not demonstrated .
CONCLUSIONS	Overgound walking training was more beneficial than body weight-supported treadmill training at improving self-selected walking speed for the participants in this study .

###24902402
OBJECTIVE	To assess the influence of simulated oral erosive/abrasive challenges on the bond strength of an etch-and-rinse two-step bonding system to enamel using an in situ/ex vivo protocol .
METHODS	Bovine enamel blocks were prepared and randomly assigned to four groups : CONT - control ( no challenge ) , ABR - 3x/day -1 minute toothbrushing ; ERO - 3x/day - 5 minutes extraoral immersion into regular Coca Cola ; and ERO+ABR - erosive protocol followed by a 1-minute toothbrushing .
METHODS	Eight blocks were placed into an acrylic palatal appliance for each volunteer ( n = 13 ) , who wore the appliance for 5 days .
METHODS	Two blocks were subjected to each of the four challenges .
METHODS	Subsequently , all the blocks were washed with tap water and Adper Single Bond 2/Filtek Z350 were placed .
METHODS	After 24 hours , 1 mm2 beams were obtained from each block to be tested with the microtensile bond strength test ( 50 N load at 0.5 mm/minute ) .
METHODS	The data were statistically analyzed by one-way RM-ANOVA and Tukey 's tests ( alpha = 0.05 ) .
RESULTS	No difference was detected among the ABR , ERO , and CONT groups ( P > 0.05 ) .
RESULTS	ERO+ABR group yielded lower bond strengths than either the ABR and ERO groups ( P < 0.0113 ) .

###24331630
OBJECTIVE	To investigate the effect of enhanced nutritional therapy on wound healing after endoscopic therapy in patients with liver cirrhosis and esophageal varices .
METHODS	Fifty patients with liver cirrhosis and esophageal varices were randomly divided into an enhanced nutritional therapy group ( n = 25 ) and a control group ( n = 25 ) .
METHODS	The enhanced nutritional therapy group received one week of enhanced nutritional supplementation , including liver nutritional elements , prior to routine endoscopic therapy .
METHODS	The routine without any change to their diet .
METHODS	The rate of transformation and status of wound healing of esophageal varices were compared between the two groups .
RESULTS	The ratio of ulcers occurring at the injection site was lower in the enhanced nutrition group than in the control group ( 16/25 vs. 23/25 ; x2 = 5.711 , P = 0.017 ) .
RESULTS	The enhanced nutrition group had only one case of minimal bleeding occurring during endoscopy as compared to the seven cases of bleeding in the control group ( x2 = 5.357 , P = 0.021 ) .
RESULTS	On average , the enhanced nutrition group required less sessions of endoscopic treatment to achieve eradication of esophageal varices than the control group ( 3.8 vs. 4.1 ; t = 2.069 , P = 0.044 ) .
CONCLUSIONS	Pre-endoscopic enhanced nutritional therapy may benefit patients with liver cirrhosis and esophageal varices by promoting recovery of procedure-related local tissue injury and occlusion of varices .

###24294838
OBJECTIVE	Most adolescents relapse within 90 days of discharge from residential substance use treatment .
OBJECTIVE	We hypothesized that contingency management ( CM ) , assertive continuing care ( ACC ) , and their combination ( CM + ACC ) would each be more effective than usual continuing care ( UCC ) .
METHODS	Following residential treatment , 337 adolescents were randomized to 4 continuing care conditions : UCC alone , CM , ACC , or CM + ACC .
METHODS	UCC was available across all conditions .
METHODS	Outcome measures over 12 months included percentage of days abstinent from alcohol , heavy alcohol , marijuana , and any alcohol or other drugs ( AOD ) using self-reports and toxicology testing and remission status at 12 months .
RESULTS	CM had significantly higher rates of abstinence than UCC for heavy alcohol use , t ( 297 ) = 2.50 , p < .01 , d = 0.34 ; any alcohol use , t ( 297 ) = 2.58 , p < .01 , d = 0.36 ; or any AOD use , t ( 297 ) = 2.12 , p = .01 , d = 0.41 ; and had a higher rate in remission , odds ratio ( OR ) = 2.45 , 90 % confidence interval ( CI ) [ 1.18 , 5.08 ] , p = .02 .
RESULTS	ACC had significantly higher rates of abstinence than UCC from heavy alcohol use , t ( 297 ) = 2.66 , p < .01 , d = 0.31 ; any alcohol use , t ( 297 ) = 2.63 , p < .01 , d = 0.30 ; any marijuana use , t ( 297 ) = 1.95 , p = .02 , d = 0.28 ; or any AOD use , t ( 297 ) = 1.88 , p = .02 , d = 0.30 ; and had higher rates in remission , OR = 2.31 , 90 % CI [ 1.10 , 4.85 ] , p = .03 .
RESULTS	The ACC + CM condition was not significantly different from UCC on any outcomes .
CONCLUSIONS	CM and ACC are promising continuing care approaches after residential treatment .
CONCLUSIONS	Future research should seek to further improve their effectiveness .

###25072523
OBJECTIVE	A randomized controlled trial ( RCT ) and an extension trial of qigong ( Chaoyi Fanhuan qigong [ CFQ ] ) in patients with fibromyalgia were recently completed .
OBJECTIVE	In the present study , a qualitative analysis of comments from the RCT was undertaken using motivation and amount of practice to determine whether initial experiences provided information relevant to outcomes .
METHODS	Participants in the RCT received instruction in qigong ( level 1 CFQ ) , practiced 45min/day for 8 weeks and continued practice to 6 months ; open-ended qualitative comments on experiences were invited at 8 weeks and 4 and 6 months .
METHODS	Extension trial participants received further instruction ( level 2 CFQ ) and practiced regularly for 8 weeks-6 months .
METHODS	Comments from the original RCT were considered as narratives for the extension trial subgroup ( n = 20 ) and thematically , according to amount of practice , for all participants who completed the RCT ( n = 73 ) .
RESULTS	Narrative comments from the RCT for those who completed the extension trial ( n = 13 ) and those who withdrew from that trial ( n = 7 ) were considered separately .
RESULTS	Participants reporting benefits within the first 8 weeks were more likely to maintain practice and report continued benefits at 4-6 months than those who withdrew from the trial .
RESULTS	Thematic comments for all who completed the RCT ( n = 73 ) were considered in relation to amount of practice ( per protocol , intermediate , minimal ) .
RESULTS	Participants who practiced per protocol during the initial 8 weeks ( 5 hours/wk ) were more likely to maintain practice over 4-6 months and to report beneficial health effects from qigong .
CONCLUSIONS	This retrospective qualitative analysis of information collected in an RCT of qigong for fibromyalgia indicates that favorable initial experiences with the practice over 8 weeks predispose to continued practice and more health effects .
CONCLUSIONS	Future individual trials and meta-analyses of qigong will need to attend to the amount , and potentially quality , of practice undertaken in considering trial outcomes .

###24722160
BACKGROUND	The aim of the present study was to evaluate the efficacy and tolerability of vandetanib plus gemcitabine ( V/G ) compared with gemcitabine alone in elderly patients with untreated advanced non-small-cell lung cancer .
METHODS	This was a phase II , randomized , double-blind study .
METHODS	A total of 124 elderly patients ( mean age , 75 yr ; age range , 70-84 yr ; 73 % men ) received V/G ( n = 61 ) or placebo plus gemcitabine ( n = 63 ) .
METHODS	Progression-free survival ( PFS ) was the primary endpoint .
METHODS	Secondary endpoints were overall survival , objective response rate , duration of response , disease control rate , time to deterioration of performance status , and safety outcomes .
RESULTS	PFS was significantly prolonged with V/G ( median , 183 days ; 95 % confidence interval , 116-214 ) compared with placebo plus gemcitabine ( median , 169 days ; 95 % confidence interval , 95-194 ; p = 0.047 ) .
RESULTS	No statistically significant differences between arms were observed in all secondary endpoints , including overall survival .
RESULTS	The addition of vandetanib to gemcitabine was well tolerated .
RESULTS	The rate of patients with 1 treatment-related adverse event was comparable in the two arms , pyrexia , dyspnea , and neutropenia being the most common adverse events .
CONCLUSIONS	V/G combination was associated with a statistically significant prolongation of PFS compared with gemcitabine alone in untreated elderly patients with advanced non-small-cell lung cancer , with an acceptable safety profile .

###25370364
BACKGROUND	Research has shown that obese individuals have cognitive deficiencies in executive function , leading to poor planning and impulse control , and decision-making difficulties .
BACKGROUND	An intervention that could help reduce these deficits and in turn help weight loss maintenance is Cognitive Remediation Therapy for Obesity ( CRT-O ) .
BACKGROUND	We aim to examine the efficacy of manualised CRT-O , which is intended to improve executive function , enhance reflective practice and help weight loss maintenance .
METHODS	A randomised controlled trial ( registered with the Australian New Zealand Clinical Trials Registry ) will be conducted .
METHODS	First , 90 obese adults ( body mass index > 30 kg/m2 ) in the community will receive three weekly sessions of a group Behaviour Weight Loss Treatment ( BWLT ) , and then will be randomised either to receive CRT-O or to enter a no-treatment control group .
METHODS	CRT-O training will comprise twice-weekly sessions of 45 minutes over a 4 to 6 week period , for a total of eight sessions .
METHODS	Measurement points will be at baseline , post CRT-O ( or 4 to 6 weeks after BWLT for the no-treatment control ) , 3 months post treatment and 1 year post treatment .
METHODS	The primary outcome will be executive function and secondary outcome measures will include participants ' body mass index , hip to waist ratio , eating behaviours and quality of life .
CONCLUSIONS	This is the first study of its kind to examine the efficacy of Cognitive Remediation Therapy for obese adults through a randomised controlled trial .
BACKGROUND	Australian New Zealand Clinical Trials Registry number : 12613000537752 .
BACKGROUND	Date of registration : 14 May 2013 .

###24852180
OBJECTIVE	The systematic pro-inflammatory responses after percutaneous coronary intervention with drug-eluting stents ( DES ) remain poorly defined .
OBJECTIVE	Therefore , we compared the systematic pro-inflammatory state of circulating mononuclear cells ( MNCs ) between DES and bare metal stent ( BMS ) implantation .
METHODS	Patients with indications for treatment with stents were randomized in a 1:1 ratio to placement of DES or BMS .
METHODS	The primary endpoint was a change of pro-inflammatory state at 12 weeks post-procedure .
RESULTS	Thirty-six consecutive patients received DES or BMS .
RESULTS	At 12 weeks after stent implantation , the lipid profile and high-sensitivity C-reactive protein ( hs-CRP ) improved significantly in both groups .
RESULTS	The mRNA levels and plasma concentrations of interleukin-6 , tumor necrosis factor - and matrix metalloproteinase-9 were significantly elevated in the DES group , which was not observed in the BMS group .
RESULTS	An increase in NF-B binding activity and a decrease in PPAR - expression in MNCs were observed in the DES group , along with increases in IB phosphorylation and p50 expression .
RESULTS	However , similar changes were not observed in the BMS group .
CONCLUSIONS	Systematic inflammatory responses were accentuated after the patients were treated percutaneously with DES , despite their improved lipid profile and hs-CRP .
CONCLUSIONS	These data may provide fundamental information for optimizing therapeutic strategy in the era of DES .

###24708338
OBJECTIVE	The aim of this randomized clinical trial ( RCT ) was to compare the clinical performance of the tunnel technique with subepithelial connective tissue graft ( TUN ) versus a coronally advanced flap with enamel matrix derivative ( CAF ) in the treatment of gingival recession defects .
OBJECTIVE	The use of innovative 3D digital measuring methods allowed to study healing dynamics at connective tissue ( CT ) - grafted sites and to evaluate the influence of the thickness of the root covering soft tissues on the outcome of surgical root coverage .
METHODS	Twenty-four patients contributed a total of 47 Miller class I or II recessions for scientific evaluation .
METHODS	Precise study models collected at baseline and follow-up examinations were optically scanned and virtually superimposed for digital evaluation of clinical outcome measures including mean marginal soft tissue thickness ( THK ) .
METHODS	Healing dynamics were measured in a defined region of interest at CT-grafted sites where volume differences between time points were calculated .
RESULTS	At 12months , recession reduction as well as mean root coverage were significantly better at CT-grafted sites treated in the TUN group ( 1.94 mm and 98.4 % respectively ) compared to the non-augmented sites of the CAF group ( 1.17 mm and 71.8 % respectively ) and statistical analysis revealed a positive correlation of THK ( 1.63 mm TUN versus 0.91 mm CAF , p < 0.0001 ) to both these variables .
RESULTS	Soft tissue healing following surgical root coverage with CT-grafting was mainly accomplished after 6months , with around two-thirds of the augmented volume being maintained after 12months .
CONCLUSIONS	The TUN resulted in thicker gingiva and better clinical outcomes compared to CAF .
CONCLUSIONS	Increased gingival thickness was associated with better surgical outcomes in terms of recession reduction and root coverage .

###25225436
OBJECTIVE	Pazopanib is an oral , multikinase inhibitor of vascular endothelial growth factor receptor ( VEGFR ) -1 / -2 / -3 , platelet-derived growth factor receptor ( PDGFR ) - / - , and c-Kit .
OBJECTIVE	Preclinical and clinical studies support VEGFR and PDGFR as targets for advanced ovarian cancer treatment .
OBJECTIVE	This study evaluated the role of pazopanib maintenance therapy in patients with ovarian cancer whose disease did not progress during first-line chemotherapy .
METHODS	Nine hundred forty patients with histologically confirmed cancer of the ovary , fallopian tube , or peritoneum , International Federation Gynecology Obstetrics ( FIGO ) stages II-IV , no evidence of progression after primary therapy consisting of surgery and at least five cycles of platinum-taxane chemotherapy were randomized 1:1 to receive pazopanib 800 mg once per day or placebo for up to 24 months .
METHODS	The primary end point was progression-free survival by RECIST 1.0 assessed by the investigators .
RESULTS	Maintenance pazopanib prolonged progression-free survival compared with placebo ( hazard ratio [ HR ] , 0.77 ; 95 % CI , 0.64 to 0.91 ; P = .0021 ; median , 17.9 v 12.3 months , respectively ) .
RESULTS	Interim survival analysis based on events in 35.6 % of the population did not show any significant difference .
RESULTS	Grade 3 or 4 adverse events of hypertension ( 30.8 % ) , neutropenia ( 9.9 % ) , liver-related toxicity ( 9.4 % ) , diarrhea ( 8.2 % ) , fatigue ( 2.7 % ) , thrombocytopenia ( 2.5 % ) , and palmar-plantar erythrodysesthesia ( 1.9 % ) were significantly higher in the pazopanib arm .
RESULTS	Treatment discontinuation related to adverse events was higher among patients treated with pazopanib ( 33.3 % ) compared with placebo ( 5.6 % ) .
CONCLUSIONS	Pazopanib maintenance therapy provided a median improvement of 5.6 months ( HR , 0.77 ) in progression-free survival in patients with advanced ovarian cancer who have not progressed after first-line chemotherapy .
CONCLUSIONS	Overall survival data to this point did not suggest any benefit .
CONCLUSIONS	Additional analysis should help to identify subgroups of patients in whom improved efficacy may balance toxicity ( NCT00866697 ) .

###24755906
BACKGROUND	Large prospective studies in patients with type 2 diabetes mellitus have demonstrated that metformin treatment improves cardiovascular prognosis , independent of glycemic control .
BACKGROUND	Administration of metformin potently limits infarct size in murine models of myocardial infarction .
BACKGROUND	This study examined , for the first time in humans , whether metformin limits ischemia-reperfusion ( IR ) injury in vivo using a well-validated forearm model of endothelial IR-injury .
METHODS	Twenty-eight healthy volunteers ( age 416 years , 10 male/16 female ) were randomized between pretreatment with metformin ( 500 mg three times a day for 3 days ) or no treatment in a Prospective Randomized Open Blinded Endpoint study .
METHODS	Brachial artery flow mediated dilation ( FMD ) was measured before and after 20 minutes of forearm ischemia and 20 minutes of reperfusion .
METHODS	FMD analysis was performed offline by investigators blinded for the treatment arm .
RESULTS	Baseline FMD did not differ between metformin pretreatment and no pretreatment ( 6.93.6 % and 6.13.5 % , respectively , p = 0.27 , n = 26 ) .
RESULTS	FMD was significantly lower after forearm IR in both treatment arms ( 4.43.3 % and 4.32.8 % , respectively , P < 0.001 in both conditions ) .
RESULTS	A linear mixed model analysis revealed that metformin treatment did not prevent the decrease in FMD by IR .
CONCLUSIONS	A 3 day treatment with metformin in healthy , middle-aged subjects does not protect against endothelial IR-injury , measured with brachial artery FMD after forearm ischemia .
CONCLUSIONS	Further studies are needed to clarify what mechanism underlies the cardiovascular benefit of metformin treatment .
BACKGROUND	ClinicalTrials.gov NCT01610401 .

###25555562
BACKGROUND	Dietary fibers are associated with enhanced satiety .
BACKGROUND	However , the mechanism of different dietary fibers contributing to satiety-related gastrointestinal ( GI ) peptide release , especially in an obese population , is still poorly understood .
BACKGROUND	Polydextrose ( PDX ) , a water-soluble glucose polymer , has demonstrated its ability to reduce energy intake at a subsequent meal , but its mechanism of action requires further research .
BACKGROUND	Also , there is limited evidence on its capacity to regulate subjective feelings of appetite .
BACKGROUND	This study examines the effects of PDX on postprandial secretion of satiety-related GI peptides , short chain fatty acids ( SCFAs ) , lactic acid , and subjective appetite ratings in obese participants .
METHODS	18 non-diabetic , obese participants ( 42.0 y , 33.6 kg/m2 ) consumed a high-fat meal ( 4293 kJ , 36 % from fat ) with or without PDX ( 15 g ) in an acute , multicenter , randomized , double-blind , placebo-controlled and crossover trial .
METHODS	Postprandial plasma concentrations of satiety-related peptides , namely ghrelin , cholecystokinin ( CCK ) , glucagon-like peptide 1 ( GLP-1 ) , and peptide YY ( PYY ) , as well as SCFAs and lactic acid were assessed .
METHODS	GI peptide , SCFA and lactate concentrations were then modeled using a linear mixed-effects model.The subjective feelings of hunger , satisfaction , and desire to eat were evaluated using visual analogue scales ( VAS ) , which were analyzed as incremental areas under the curve ( iAUC ) during the satiation and satiety periods .
RESULTS	We found that PDX supplementation increased plasma GLP-1 levels more than the placebo treatment ( P = 0.02 ) .
RESULTS	In the whole group , GLP-1 concentrations found in participants older than 40 years old were significantly lower ( P = 0.01 ) as compared to those aged 40 years or less .
RESULTS	There were no statistically significant differences in postprandial ghrelin , CCK , or PYY responses .
RESULTS	The lactic acid concentrations were significantly ( P = 0.01 ) decreased in the PDX group , while no significant changes in SCFAs were found .
RESULTS	PDX reduced iAUC for hunger by 40 % ( P = 0.03 ) and marginally increased satisfaction by 22.5 % ( P = 0.08 ) during the post-meal satiety period .
CONCLUSIONS	Polydextrose increased the postprandial secretion of the satiety hormone GLP-1 and reduced hunger after a high-fat meal .
CONCLUSIONS	PDX also reduced the elevated postprandial lactic acid levels in plasma .
CONCLUSIONS	Therefore , PDX may offer an additional means to regulate inter-meal satiety and improve postprandial metabolism in obese participants .

###25581612
OBJECTIVE	To evaluate the effect of sustained American College of Rheumatology ( ACR ) / European League Against Rheumatism ( EULAR ) Boolean remission on residual joint inflammation assessed by magnetic resonance imaging ( MRI ) and to secondarily evaluate other clinical definitions of remission , within an early seropositive rheumatoid arthritis ( RA ) cohort .
METHODS	A subcohort of 118 RA patients was enrolled from patients who completed the 2-year , double-blind randomized Treatment of Early Aggressive Rheumatoid Arthritis ( TEAR ) trial .
METHODS	Patients received a single contrast-enhanced 1.5 T MRI of their most involved wrist .
METHODS	Two readers scored MRIs for synovitis , osteitis , tenosynovitis , and erosions .
METHODS	Clinical assessments were performed every 3 months during the trial and at time of MRI .
RESULTS	The subcohort was 92 % seropositive with mean age 51 years , duration 4.1 months , and Disease Activity Score in 28 joints using the erythrocyte sedimentation rate 5.8 at TEAR entry .
RESULTS	Total MRI inflammatory scores ( tenosynovitis + synovitis + osteitis ) were lower among patients in clinical remission .
RESULTS	Lower MRI scores were correlated with longer duration of Clinical Disease Activity Index ( CDAI ) remission ( = 0.22 , P = 0.03 ) .
RESULTS	At the time of MRI , 89 patients had no wrist pain/tenderness/swelling ; however , all 118 patients had MRI evidence of residual joint inflammation after 2 years .
RESULTS	No statistically significant differences in damage or MRI inflammatory scores were observed across treatment groups .
CONCLUSIONS	This is the first detailed appraisal describing the relationship between clinical remission cut points and MRI inflammatory scores within an RA randomized controlled trial .
CONCLUSIONS	The most stringent remission criteria ( 2011 ACR/EULAR and CDAI ) best differentiate the total MRI inflammatory scores .
CONCLUSIONS	These results document that 2 years of triple therapy or tumor necrosis factor plus methotrexate treatment in early RA does not eliminate MRI evidence of joint inflammation .

###24862255
OBJECTIVE	To assess the efficacy , safety and tolerability of sodium valproate ( 800mg/die ) compared with placebo in medication-overuse headache patients with a history of migraine without aura .
METHODS	This is a multicenter , randomized , double-blind , placebo-controlled study enrolled medication-overuse headache patients for a 3-month treatment period with sodium valproate ( 800mg/day ) or placebo after a 6 day outpatient detoxification regimen , followed by a 3-month follow-up .
METHODS	Primary outcome was defined by the proportion of patients achieving 50 % reduction in the number of days with headache per month ( responders ) from the baseline to the last 4 weeks of the 3-month treatment .
METHODS	Multivariate logistic regression models were used on the primary endpoint , adjusting for age , sex , disease duration , comorbidity and surgery .
METHODS	The last-observation-carried-forward method was used to adjust for missing values .
RESULTS	Nine sites enrolled 130 patients and , after a 6-day detoxification phase , randomized 88 eligible patients .
RESULTS	The 3-month responder rate was higher in the sodium valproate ( 45.0 % ) than in the placebo arm ( 23.8 % ) with an absolute difference of about 20 % ( p = 0.0431 ) .
RESULTS	Sodium valproate had safety and tolerability profiles comparable to placebo .
CONCLUSIONS	The present study supports the efficacy and safety of sodium valproate in the treatment of medication overuse headache with history of migraine after detoxification .

###25266929
BACKGROUND	Internet-based guided self-help has been successfully used in the general population , but it is unknown whether this method can be effectively used in outpatient clinics for patients waiting for face-to-face psychotherapy for phobias .
OBJECTIVE	The aim was to assess the clinical effectiveness of Phobias Under Control , an Internet-based intervention based on exposure therapy with weekly guidance .
METHODS	We conducted a randomized controlled trial , recruiting 212 outpatients scheduled to receive face-to-face psychotherapy for any type of phobia at an outpatient clinic .
METHODS	Participants suffering from at least 1 DSM-IV or ICD-10 classified phobia ( social phobia , agoraphobia with or without panic disorder , and/or specific phobia as ascertained by a telephone interview at baseline ) were randomly allocated to either a 5-week Internet-based guided self-help program based on exposure therapy with weekly student support followed by face-to-face psychotherapy ( n = 105 ) or a wait-list control group followed by face-to-face psychotherapy ( n = 107 ) .
METHODS	Primary outcome was the Fear Questionnaire ( FQ ) .
METHODS	Secondary outcomes were the Beck Anxiety Inventory ( BAI ) and Center of Epidemiological Studies-Depression scale ( CES-D ) .
METHODS	Assessments took place by telephone at baseline ( T0 ) and on the Internet at posttest ( T1 , self-assessment at 5 weeks after baseline ) .
METHODS	Missing data at T1 were imputed .
RESULTS	At posttest , analysis of covariance on the intention-to-treat sample showed significant but small effect sizes between intervention and control groups on the FQ ( d = 0.35 , P = .02 ) , CES-D ( d = 0.34 , P = .03 ) , and a nonsignificant effect size on the BAI ( d = 0.28 .
RESULTS	P = .05 ) .
RESULTS	Although initial acceptance was good , high nonresponse was observed , with 86 of 212 participants ( 40.5 % ) lost to follow-up at T1 and only 14 of 105 ( 13.3 % ) intervention participants finishing all 5 weeks .
CONCLUSIONS	Phobias Under Control is modestly effective in lowering phobic and depressive symptoms in a relatively short period and may be clinically beneficial when implemented in routine outpatient practice .
BACKGROUND	Netherlands Trial Register NTR2233 ; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2233 ( Archived by WebCite at http://www.webcitation.org/6O2ioOQSs ) .

###24987838
BACKGROUND	Non-invasive characterization of a tumor 's molecular features could enhance treatment management .
BACKGROUND	Quantitative computed tomography ( CT ) based texture analysis ( QTA ) has been used to derive tumor heterogeneity information , and the appearance of the tumors has been shown to relate to patient outcome in non-small cell lung cancer ( NSCLC ) and other cancers .
BACKGROUND	In this study , we examined the potential of tumoral QTA to differentiate K-ras mutant from pan-wildtype tumors and its prognostic potential using baseline pre-treatment non-contrast CT imaging in NSCLC .
METHODS	Tumor DNA from patients with early-stage NSCLC was analyzed on the LungCarta Panel .
METHODS	Cases with a K-ras mutation or pan-wildtype for 26 oncogenes and tumor suppressor genes were selected for QTA .
METHODS	QTA was applied to regions of interest in the primary tumor .
METHODS	Non-parametric Mann Whitney test assessed the ability of the QTA , clinical and patient characteristics to differentiate between K-ras mutation from pan-wildtype .
METHODS	A recursive decision tree was developed to determine whether the differentiation of K-ras mutant from pan-wildtype tumors could be improved by sequential application of QTA parameters .
METHODS	Kaplan-Meier survival analysis assessed the ability of these markers to predict survival .
RESULTS	QTA was applied to 48 cases identified , 27 had a K-ras mutation and 21 cases were pan-wildtype .
RESULTS	Positive skewness and lower kurtosis were significantly associated with the presence of a K-ras mutation .
RESULTS	A five node decision tree had sensitivity , specificity , and accuracy values ( 95 % CI ) of 96.3 % ( 78.1-100 ) , 81.0 % ( 50.5-97 .4 ) , and 89.6 % ( 72.9-97 .0 ) ; respectively .
RESULTS	Kurtosis was a significant predictor of OS and DFS , with a lower kurtosis value linked with poorer survival .
CONCLUSIONS	Lower kurtosis and positive skewness are significantly associated with K-ras mutations .
CONCLUSIONS	A QTA feature such as kurtosis is prognostic for OS and DFS .
CONCLUSIONS	Non-invasive QTA can differentiate the presence of K-ras mutation from pan-wildtype NSCLC and is associated with patient survival .

###25218696
BACKGROUND	Edentulism and sleep disturbance are chronic conditions that are common in older people and have serious adverse consequences for their functioning and quality of life .
BACKGROUND	Edentulism can disturb sleep through the alteration of the craniofacial structure and surrounding soft tissue .
BACKGROUND	However , the effect of prosthetic rehabilitation of edentulism on sleep quality is still not well understood .
BACKGROUND	The objectives of this study are to test whether nocturnal denture wear affects sleep quality , daytime sleepiness , and the oral health related quality of life of edentate older people with moderate to severe sleep apnea , and to identify modifiers of effect of nocturnal denture wear .
METHODS	We will carry out a single-blind randomized cross-over trial .
METHODS	Seventy edentate older people with moderate to severe obstructive sleep apnea will be enrolled .
METHODS	The study participants will be assigned to wear and not wear their dentures on alternate periods of 30 days .
METHODS	The outcome measures will be sleep quality ( assessed by portable polysomnography ) , daytime sleepiness ( assessed by the Epworth Sleepiness Scale ) , and oral health related quality of life ( assessed by validated questionnaire ) .
METHODS	A number of characteristics ( sociodemographic , oropharyngeal morphology , oral and prosthesis characteristics , and perceived general health quality of life ) will be assessed by means of clinical examination , 3D imaging of the craniofacial structure , and validated questionnaires at baseline .
METHODS	Linear mixed effects regression models for repeated measures will be fitted to test the study hypotheses .
METHODS	The main analyses will be based on the intention-to-treat principle .
METHODS	To assess the robustness of the findings to potential incomplete adherence , sensitivity analyses will be conducted while applying the per-protocol principle .
CONCLUSIONS	This practice-relevant evidence could represent a preventive approach to improve sleep characteristics of the older population and improve their well-being and quality of life .
BACKGROUND	ClinicalTrials.gov NCT01868295 .

###24972708
OBJECTIVE	To study the efficacy and safety of certolizumab pegol ( CZP ) in patients with active rheumatoid arthritis ( RA ) who had discontinued an initially effective TNF inhibitor ( TNF-IR ) .
METHODS	A randomised 12-week double-blind trial with CZP ( n = 27 ) or placebo ( n = 10 ) followed by an open-label 12 week extension period with CZP .
RESULTS	Baseline characteristics of the 2 groups were similar .
RESULTS	ACR20 response ( primary end point ) at week 12 was achieved in 61.5 % , and none of CZP and placebo-treated patients , respectively .
RESULTS	Weeks 12-24 showed a maximum effect for CZP at 12 weeks , and that placebo patients switched blindly to CZP attained similar results seen with CZP in weeks 0-12 .
RESULTS	Since this result was highly significant , study inclusion was terminated after entry of 33.6 % of the originally planned 102 patients .
RESULTS	Adverse events occurred in 16/27 ( 59.3 % ) CZP subjects and 4/10 ( 40 % ) placebo subjects .
RESULTS	There were no serious adverse events , neoplasms , opportunistic , or serious infections .
CONCLUSIONS	This first , prospective , blinded trial of CZP in secondary TNF-IR shows that the ACR20 response rate observed with CZP was higher than that reported in most previous studies of TNF-IR .
CONCLUSIONS	Additionally , CZP demonstrated good safety and tolerability .
CONCLUSIONS	This study supports the use of CZP in RA patients who are secondary non-responders to anti-TNF therapies .

###25210961
OBJECTIVE	To compare two thoracotomy closure techniques ( pericostal and transcostal suture ) in terms of postoperative pain and pulmonary function .
METHODS	This was a prospective , randomized , double-blind study carried out in the Department of Thoracic Surgery of the Luzia de Pinho Melo Hospital das Clnicas and at the University of Mogi das Cruzes , both located in the city of Mogi das Cruzes , Brazil .
METHODS	We included 30 patients ( 18-75 years of age ) undergoing posterolateral or anterolateral thoracotomy .
METHODS	The patients were randomized into two groups by the type of thoracotomy closure : pericostal suture ( PS ; n = 16 ) and transcostal suture ( TS ; n = 14 ) .
METHODS	Pain intensity during the immediate and late postoperative periods was assessed by a visual analogic scale and the McGill Pain Questionnaire .
METHODS	Spirometry variables ( FEV1 , FVC , FEV1/FVC ratio , and PEF ) were determined in the preoperative period and on postoperative days 21 and 60 .
RESULTS	Pain intensity was significantly greater in the PS group than in the TS group .
RESULTS	Between the preoperative and postoperative periods , there were decreases in the spirometry variables studied .
RESULTS	Those decreases were significant in the PS group but not in the TS group .
CONCLUSIONS	The patients in the TS group experienced less immediate and late post-thoracotomy pain than did those in the PS group , as well as showing smaller reductions in the spirometry parameters .
CONCLUSIONS	Therefore , transcostal suture is recommended over pericostal suture as the thoracotomy closure technique of choice .

###25719692
BACKGROUND	Botulinum toxin type A has been widely used to correct unwanted hyperfunctional facial lines .
BACKGROUND	Most forms of botulinum toxin type A currently used require reconstitution , which is very inconvenient for users .
BACKGROUND	The authors compared the efficacy and safety of a newly developed liquid-type botulinum toxin type A ( MT10109L ) and onabotulinumtoxinA ( Botox ) for moderate to severe glabellar lines .
METHODS	A double-blind , randomized , active drug-controlled , phase III study with 168 enrolled subjects was performed .
METHODS	The primary efficacy endpoint was the improvement rate at maximum frown at week 4 by the investigators ' live assessment .
METHODS	The secondary efficacy endpoint included the improvement rate at maximum frown at week 16 and at rest at weeks 4 and 16 by live assessment , and the improvement rate at maximum frown and at rest based on photographic assessment at week 4 .
METHODS	Self-assessment and self-satisfaction with glabellar line improvement were also evaluated .
RESULTS	The improvement rate at maximum frown by live assessment was not significantly different between the MT10109L and Botox groups .
RESULTS	In addition , the improvement rate of glabellar lines at rest based on the investigators ' live assessment and photographic assessment was similar in both treatment groups .
RESULTS	However , the improvement rate at maximum frown by live assessment at week 16 was significantly higher in the MT10109L group compared with the Botox group .
RESULTS	There were no severe adverse events .
CONCLUSIONS	The efficacy and safety of MT10109L were comparable to those of Botox for the management of glabellar frown lines .
CONCLUSIONS	MT10109L provides greater convenience because it does not require dilution and has long-lasting effects .
METHODS	Therapeutic , II .

###24415559
OBJECTIVE	This prospective , randomized , multicenter trial evaluated the 6-month success rate of sacral neuromodulation ( SNM ) with InterStim Therapy versus standard medical therapy ( SMT ) for overactive bladder ( OAB ) .
METHODS	Enrolled subjects discontinued OAB medications prior to and during baseline data collection and were randomized 1:1 to SNM or SMT .
METHODS	Subjects had bothersome symptoms of overactive bladder ( OAB ) including urinary urge incontinence ( 2 leaks/72hr ) and/or urgency-frequency ( 8voids/day ) .
METHODS	Subjects failed at least one anticholinergic medication , and had at least one medication not yet attempted .
METHODS	The primary objective was to compare OAB therapeutic success rate at 6 months between SNM and SMT .
RESULTS	Overall , 147 subjects were randomized ( 70 to SNM and 77 to SMT ) ; 93 % were female and mean age was 58 .
RESULTS	The primary intent to treat analysis showed OAB therapeutic success was significantly greater in the SNM group ( 61 % ) than the SMT group ( 42 % ; P = 0.02 ) .
RESULTS	In the as treated analysis , OAB therapeutic success was 76 % for SNM and 49 % for SMT ( P = 0.002 ) .
RESULTS	The SNM group showed significant improvements in quality of life versus the SMT group ( all P < 0.001 ) and 86 % of SNM subjects reported improved or greatly improved urinary symptom interference score at 6 months , compared to 44 % for SMT subjects .
RESULTS	The device-related adverse event rate was 30.5 % and the medication-related adverse event rate was 27.3 % .
CONCLUSIONS	This study demonstrates superior objective and subjective success of SNM compared to SMT .
CONCLUSIONS	SNM is shown to be a safe and effective treatment for OAB patients with mild to moderate symptoms .
CONCLUSIONS	Neurourol .
CONCLUSIONS	Urodynam .
CONCLUSIONS	34:224 -230 , 2015.2014 Wiley Periodicals , Inc. .

###25193295
BACKGROUND	Isolation of the pulmonary veins ( PVs ) for the treatment of atrial fibrillation ( AF ) is often supplemented with linear lesions within the left atrium ( LA ) .
BACKGROUND	However , there are conflicting data on the effects of creating a roof line ( RL ) joining the superior PVs in paroxysmal atrial fibrillation ( PAF ) .
RESULTS	A cohort of 120 patients with drug-refractory PAF referred for ablation were prospectively randomized into 2 strategies : ( 1 ) PV isolation in combination with RL ablation ( LA roof ablation [ LARA ] -1 : 59 patients ) or ( 2 ) PV isolation ( LARA-2 : 61 patients ) .
RESULTS	Follow-up was performed at 1 , 3 , and 6 months after the procedure and every 6 months thereafter .
RESULTS	After a 3-month blanking period , recurrence was defined as the ocurrence of any atrial tachyarrhythmia lasting 30 seconds .
RESULTS	PV isolation was achieved in 89 % and complete RL block in 81 % .
RESULTS	RF duration , fluoroscopy , and procedural times were slightly , but not significantly , longer in the LARA-1 group .
RESULTS	After 1510 months , there was no difference in the arrhythmia-free survival after a single AF ablation procedure ( LARA-1 : 59 % vs. LARA-2 : 56 % at 12 months ; log rank P = 0.77 ) .
RESULTS	The achievement of complete RL block did not influence the results .
RESULTS	The incidence of LA macroreentrant tachycardias was 5.1 % in the LARA-1 group ( n = 3 ) versus 8.2 % in the LARA-2 ( n = 5 ) ( P = ns ) .
RESULTS	Univariate analysis only identified AF duration as a covariate associated with arrhythmia recurrence ( hazard ratio , 1.01 [ 95 % confidence interval , 1.002 to 1.012 ] ; P < 0.01 ) .
CONCLUSIONS	The linear block at the LA roof is not associated with an improved clinical outcome compared with PV isolation alone .
BACKGROUND	ClinicalTrials.gov .
BACKGROUND	Unique identifier : NCT01203241 .

###24254033
BACKGROUND	It is estimated that 1 in 5 children in the United States is affected by chronic pain .
BACKGROUND	Increasing adaptive coping strategies and decreasing stress may be important in treatment .
BACKGROUND	Research has suggested that mindfulness can help alleviate symptoms associated with medical illnesses and increase quality of life .
BACKGROUND	Little is known about the effectiveness of mindfulness-based stress reduction ( MBSR ) in youth , partly due to insufficient methodological rigor in related studies .
OBJECTIVE	The primary purpose of the present study was to examine the feasibility , acceptability , and effectiveness of MBSR for a treatment-seeking sample of youth with chronic pain .
METHODS	The current study was the first randomized , controlled pilot study of MBSR for pediatric chronic pain .
METHODS	The research team had intended to use block randomization involving a total of five recruitment waves , with each wave consisting of one MBSR group and one psychoeducation group .
METHODS	Due to difficulties with recruitment and attrition before the start of either group , however , only MBSR was conducted at each wave after the first wave .
METHODS	Participants were recruited from a multidisciplinary pain clinic in a large , Midwestern children 's hospital .
METHODS	The final sample included six adolescents between the ages of 12 and 17 y , four in the MBSR group and two in the psychoeducation group .
METHODS	Weekly sessions for the MBSR group were 90 min in length and followed a structured protocol .
METHODS	Sessions included a review of homework , an introduction to and practice of meditation , discussion of the session , and a review of the home practice assignment .
METHODS	The psychoeducation group participated in six group sessions , which were based on a cognitive-behavioral model of pain , and discussion topics included the nature of chronic pain and stress management .
METHODS	Health-related quality of life , pain catastrophizing , anxiety , functional disability , mindfulness , and treatment acceptability were all assessed pre - and postintervention as well as at follow-up .
RESULTS	Recruitment and retention difficulties were experienced .
RESULTS	Qualitative examination of participants ' scores suggested increased mindfulness but inconsistent patterns on other outcome measures .
CONCLUSIONS	The research team highlighted critical challenges faced by potential researchers aiming to investigate MBSR for pediatric chronic pain , and the study provides recommendations for research and implications for clinical practice .

###24400915
BACKGROUND	The use of opioid analgesics in prehospital trauma care has been reported to have negative side effects on the airway and circulation .
BACKGROUND	Several studies of urban trauma management have recommend ketamine as a safe and efficient analgesic .
BACKGROUND	To date , however , no controlled trials of prehospital opioid analgesics versus ketamine in rural trauma management have been published .
OBJECTIVE	This study aimed to compare the analgesic effects and side effects of ketamine and morphine in a prehospital , low-resource setting .
METHODS	The study was conducted with a prospective , cluster-randomized design .
METHODS	The Quang Tri province of Vietnam was divided into two sectors that alternated monthly between ketamine and morphine treatments .
METHODS	A total of 169 trauma patients were treated outside hospital settings with ketamine , while 139 patients were treated with morphine .
RESULTS	The treatment effects were measured by comparing the Visual Analogue Scale ( VAS ) ratings in the field to those upon on admission .
RESULTS	The analgesic effects were positive and similar for the two drugs .
RESULTS	The rate of vomiting was significantly lower in the ketamine group ( 5 % ) than in the morphine group ( 19 % , 95 % CI for difference 8-22 % ) .
RESULTS	The rate of hallucinations and agitation was higher in ketamine-treated patients ( 11 % ) than in the morphine-treated patients ( 1.5 % , 95 % CI for difference 4-16 % ) .
RESULTS	In this study , patients with head trauma ( n = 57 ) showed no adverse effects on consciousness level after being treated with ketamine .
CONCLUSIONS	Ketamine had an analgesic effect similar to morphine and carried a lower risk of airway problems .
CONCLUSIONS	The risk of hallucinations and agitation was increased in the ketamine group .
CONCLUSIONS	These findings are of medical significance , particularly in rough and low-resource scenarios .

###25399658
BACKGROUND	Dual antiplatelet therapy is recommended after coronary stenting to prevent thrombotic complications , yet the benefits and risks of treatment beyond 1 year are uncertain .
METHODS	Patients were enrolled after they had undergone a coronary stent procedure in which a drug-eluting stent was placed .
METHODS	After 12 months of treatment with a thienopyridine drug ( clopidogrel or prasugrel ) and aspirin , patients were randomly assigned to continue receiving thienopyridine treatment or to receive placebo for another 18 months ; all patients continued receiving aspirin .
METHODS	The coprimary efficacy end points were stent thrombosis and major adverse cardiovascular and cerebrovascular events ( a composite of death , myocardial infarction , or stroke ) during the period from 12 to 30 months .
METHODS	The primary safety end point was moderate or severe bleeding .
RESULTS	A total of 9961 patients were randomly assigned to continue thienopyridine treatment or to receive placebo .
RESULTS	Continued treatment with thienopyridine , as compared with placebo , reduced the rates of stent thrombosis ( 0.4 % vs. 1.4 % ; hazard ratio , 0.29 [ 95 % confidence interval { CI } , 0.17 to 0.48 ] ; P < 0.001 ) and major adverse cardiovascular and cerebrovascular events ( 4.3 % vs. 5.9 % ; hazard ratio , 0.71 [ 95 % CI , 0.59 to 0.85 ] ; P < 0.001 ) .
RESULTS	The rate of myocardial infarction was lower with thienopyridine treatment than with placebo ( 2.1 % vs. 4.1 % ; hazard ratio , 0.47 ; P < 0.001 ) .
RESULTS	The rate of death from any cause was 2.0 % in the group that continued thienopyridine therapy and 1.5 % in the placebo group ( hazard ratio , 1.36 [ 95 % CI , 1.00 to 1.85 ] ; P = 0.05 ) .
RESULTS	The rate of moderate or severe bleeding was increased with continued thienopyridine treatment ( 2.5 % vs. 1.6 % , P = 0.001 ) .
RESULTS	An elevated risk of stent thrombosis and myocardial infarction was observed in both groups during the 3 months after discontinuation of thienopyridine treatment .
CONCLUSIONS	Dual antiplatelet therapy beyond 1 year after placement of a drug-eluting stent , as compared with aspirin therapy alone , significantly reduced the risks of stent thrombosis and major adverse cardiovascular and cerebrovascular events but was associated with an increased risk of bleeding .
CONCLUSIONS	( Funded by a consortium of eight device and drug manufacturers and others ; DAPT ClinicalTrials.gov number , NCT00977938 . )

###24332196
BACKGROUND	Ivabradine is a pure heart rate-lowering agent that acts by inhibiting I ( f ) , an important ionic current involved in pacemaker activity in the cells of the sinoatrial node .
BACKGROUND	In the 2012 European Society of Cardiology Guidelines on Heart Failure , it was recommended that patients with a persistently high heart rate , despite treatment with an evidence-based dose of a - blocker , should be considered for treatment with ivabradine .
OBJECTIVE	The aim of this study was to explore the pharmacokinetic/pharmacodynamic properties and safety profile of ivabradine in healthy Chinese men .
METHODS	This Phase I , randomized , open-label , parallel-arm , single - and multiple-dose study was conducted at the Clinical Pharmacology Center of the Cardiovascular Institute and Fu Wai Hospital at the Chinese Academy of Medical Sciences & Peking Union Medical College in Beijing , People 's Republic of China .
METHODS	Healthy , nonsmoking volunteers were randomly assigned to 1 of 3 treatment groups based on treatment with 5 , 10 or 20 mg of ivabradine .
METHODS	After a single dose , the subjects assigned to the 3 dose groups received repeated oral doses of ivabradine BID for 6 days .
METHODS	The plasma concentrations of ivabradine were determined by using a HPLC-MS/MS method .
METHODS	Systolic and diastolic blood pressure and heart rate measurements were taken , and ECG and Holter monitoring was performed .
METHODS	Tolerability was assessed throughout the study by physical and ophthalmologic examinations , vital signs measurement , laboratory analyses , and monitoring of adverse effects .
RESULTS	A total of 36 healthy Chinese men were enrolled in the study .
RESULTS	After the single dose , plasma ivabradine Cmax and AUC increased approximately linearly with dosage , no statistically significant differences were found in t or Tmax between the dose groups .
RESULTS	After multiple doses , there was no significant change in Tmax compared with the results after a single dose .
RESULTS	After repeated doses , t , Cmax , and AUC increased significantly ( P < 0.001 ) .
RESULTS	After a single dose , a significant reduction in heart rate at 2 hours ' postdose was observed in the highest dose group , whereas after repeated doses , a significant reduction in heart rate was observed from 2 to 4 hours ' postdose for all 3 groups .
RESULTS	The mean ( SD ) heart rate after repeated doses decreased 12.5 ( 4.8 ) , 12.4 ( 6.9 ) , and 20.5 ( 5.8 ) beats/min for the 5 - , 10 - , and 20-mg dose groups , respectively .
RESULTS	No clear trend in the changes in QTc , systolic and diastolic blood pressures , or respiration rate was observed .
RESULTS	Ivabradine was well tolerated in these healthy Chinese men .
CONCLUSIONS	The results of the study in a small population of healthy Chinese men suggest that the PK properties of ivabradine are linear with respect to dosing .
CONCLUSIONS	After single and repeated oral administration of ivabradine , a significant decrease in heart rate was observed .
CONCLUSIONS	Ivabradine appeared well tolerated in the population studied .
CONCLUSIONS	Trial identifier : ACTRN1261300027741 .

###24239203
OBJECTIVE	This study sought to compare paclitaxel-eluting balloon ( PEB ) with conventional percutaneous transluminal angioplasty ( PTA ) , followed by systematic implantation of a self-expanding nitinol bare-metal stent ( BMS ) in patients at risk for restenosis .
BACKGROUND	PTA is an effective strategy for treating atherosclerosis of the femoropopliteal axis ( FPA ) .
BACKGROUND	Whereas PEB have shown advantage over uncoated balloons in the treatment of simple lesions , it is unknown whether these results are applicable to complex degrees of FPA atheroma .
METHODS	A total of 104 patients ( 110 FPA lesions in 110 limbs ) were randomly assigned to either PEB + BMS or PTA + BMS .
METHODS	The primary endpoint was 12-month binary restenosis .
METHODS	Secondary endpoints were freedom from target lesion revascularization and major amputation .
METHODS	Post hoc subanalyses were performed for the comparison of long ( 100 mm ) versus short lesions and true lumen versus subintimal approach .
RESULTS	Mean lesion length was 94 60 versus 96 69 mm in the PEB + BMS and PTA + BMS groups ( p = 0.8 ) , respectively .
RESULTS	The primary endpoint occurred in 9 ( 17 % ) versus 26 ( 47.3 % ) of lesions in the PEB + BMS and PTA + BMS groups ( p = 0.008 ) , respectively .
RESULTS	A near-significant ( p = 0.07 ) 1-year freedom from target lesion revascularization advantage was observed in the PEB + BMS group .
RESULTS	No major amputation occurred .
RESULTS	No significant difference was observed according to lesion characteristics or technical approach .
CONCLUSIONS	Pre-dilation with PEB angioplasty prior to BMS implantation , as compared to PTA + BMS in complex FPA lesions , reduces restenosis and target lesion revascularization at 12-month follow-up .
CONCLUSIONS	Restenosis reduction is maintained irrespective of lesion length and recanalization technique .
CONCLUSIONS	( DrugEluting Balloon in Peripheral Intervention for the Superficial Femoral Artery [ DEBATE-SFA ] ; NCT01556542 ) .

###24619324
BACKGROUND	Organizational and wider health system factors influence the implementation and success of interventions .
BACKGROUND	Clinical Pathways in Acute Coronary Syndromes 2 is a cluster randomized trial of a clinical pathway-based intervention to improve acute coronary syndrome care in hospitals in China .
BACKGROUND	We performed a qualitative evaluation to examine the system-level barriers to implementing clinical pathways in the dynamic healthcare environment of China .
RESULTS	A qualitative descriptive analysis of 40 in-depth interviews with health professionals conducted in a sample of 10 hospitals purposively selected to explore barriers to implementation of the intervention .
RESULTS	Qualitative data were analyzed using the Framework method .
RESULTS	In-depth interviews identified 5 key system-level barriers to effective implementation : ( 1 ) leadership support for implementing quality improvement , ( 2 ) variation in the capacity of clinical services and quality improvement resources , ( 3 ) fears of patient disputes and litigation , ( 4 ) healthcare funding constraints and high out-of-pocket expenses , and ( 5 ) patient-related factors .
CONCLUSIONS	System-level barriers affect the ability of acute coronary syndrome clinical pathways to change practice .
CONCLUSIONS	Addressing these barriers in the context of current and planned national health system reform will be critical for future improvements in the management of acute coronary syndromes , and potentially other hospitalized conditions , in China .
CONCLUSIONS	Clinical Trial Registration - URL : http://www.anzctr.org.au/default.aspx .
CONCLUSIONS	Register .
CONCLUSIONS	Unique identifier : ACTRN12609000491268 .

###25499342
BACKGROUND	Fractional flow reserve ( FFR ) - guided percutaneous coronary intervention ( PCI ) improved outcomes compared with an angiography-guided strategy in patients with multivessel coronary artery disease ( CAD ) .
BACKGROUND	However , the effect of age on FFR has not been well-studied .
BACKGROUND	We aimed to evaluate the impact of age on the favorable results of routine FFR-guided PCI for multivessel CAD .
METHODS	We compared 1 year outcomes between FFR-guided PCI and angiography-guided PCI in the 512 patients enrolled in the FAME study < 65 years old compared to the 493 patients 65 years old .
METHODS	We also evaluated the effect of age on the FFR result of varying degrees of visually estimated coronary stenosis .
RESULTS	The 1-year rate of death , myocardial infarction or repeat revascularization in the angiography-guided group tended to be higher than in the FFR-guided group for both those patients < 65 ( 17.2 % vs. 12.0 % , P = 0.098 ) and those 65 years old ( 19.7 % vs. 14.3 % , P = 0.111 ) with no significant interaction based on age ( P = 0.920 ) .
RESULTS	Older patients had higher FFR in vessels with 50 % to 70 % stenosis ( 0.83 0.11 vs. 0.80 0.13 , P = 0.028 ) and in vessels with 71 % to 90 % stenosis ( 0.69 0.15 vs. 0.65 0.16 , P = 0.002 ) .
RESULTS	The proportion of functionally significant lesions ( FFR 0.80 ) in vessels with 71 % to 90 % stenosis was significantly lower in elderly compared to younger patients ( 75.3 % vs. 84.1 % , P = 0.013 ) .
CONCLUSIONS	FFR-guided PCI is beneficial regardless of age , however , older patients have fewer functionally significant lesions , despite a similar angiographic appearance .

###24661520
OBJECTIVE	To evaluate the efficacy and safety of ribavirin aerosol in children with hand-foot-mouth disease ( HFMD ) .
METHODS	A randomized , double-blind , placebo-controlled trial was performed .
METHODS	A total of 119 children with mild HFMD were randomly divided into an observed group ( n = 59 ) and a control group ( n = 60 ) .
METHODS	In the observed group , ribavirin aerosol was given four times within the first hour , followed by once every other hour for the remaining time of the day and day 2 ; from days 3 to 7 , it was given 4 times per day , with 2-3 sprays every time , for 7 days .
METHODS	In the control group , placebo was given in the same way as in the observed group .
METHODS	Additionally , both groups used oral antiviral liquid .
METHODS	The scores of clinical symptoms including oral ulcer , skin rash , nasal congestion , runny nose , sneezing , cough , and fever before and after treatment were recorded to evaluate treatment outcomes .
METHODS	Throat swabs were taken before treatment and 5-7 days after treatment to measure viral load by RT-PCR and to compare the negative conversion rate between the two groups .
RESULTS	Fifty-seven patients in the observed group and 56 patients in the control group were tested according to the original research design .
RESULTS	After 5-7 days of treatment , the observed group had a significantly higher overall negative conversion rate of enterovirus than the control group ( P < 0.01 ) .
RESULTS	The overall marked response rate and overall response rate of the observed group were 89 % and 89 % , respectively , significantly higher than those of the control group ( 29 % and 43 % ) .
RESULTS	During treatment , there were no adverse reactions such as dizziness , vomiting , and notable decreases in hemoglobin , white blood cells , and platelets in the two groups .
CONCLUSIONS	Ribavirin aerosol can be effectively and safely used for treating mild HFMD .
CONCLUSIONS	With low dosage and few adverse reactions , it holds promise for clinical application .

###24296324
BACKGROUND	Lowering blood pressure ( BP ) and reducing diurnal variation are important for the prevention of stroke in patients with hypertension .
OBJECTIVE	This study was conducted to compare the BP-lowering and diurnal BP variation effects of amlodipine and losartan on acute stroke patients .
METHODS	Seventy-seven hypertensive patients with acute stroke were enrolled in this randomized , double-blind , single-center clinical trial .
METHODS	They were randomly assigned to receive either amlodipine or losartan daily .
METHODS	To evaluate whether amlodipine was noninferior to losartan , ambulatory BP monitoring was performed before the drugs were first administered and at the end of week 8 .
METHODS	BP variables analyzed included the mean awake , sleep , morning , evening , and prewake BP values ; the nocturnal dipping status ; and the morning surge .
RESULTS	Thirty-nine patients in the amlodipine group and 38 patients in the losartan group completed the follow-up .
RESULTS	In the baseline characteristics , mean age was 63.6 years , and 68.8 % were male .
RESULTS	In the intention-to-treat analysis , the mean ( SD ) systolic BP decreased 14.82 ( 11.71 ) mm Hg in the amlodipine group and 13.11 ( 12.69 ) mm Hg in the losartan group , and amlodipine proved noninferior to losartan ( mean difference , 1.71 mm Hg [ 95 % CI , -3.83 to 7.26 ] ) .
RESULTS	However , in the per-protocol analysis , noninferiority was not proven ( BP reduction , 16.06 [ 11.33 ] vs 17.17 [ 11.85 ] mm Hg ; mean difference , -1.11 mm Hg [ 95 % CI , -6.88 to 4.65 ] ) .
RESULTS	Amlodipine had a greater tendency than losartan to produce a blunt morning surge .
CONCLUSIONS	The noninferiority of amlodipine was not confirmed by the per-protocol analysis .
CONCLUSIONS	However , amlodipine showed a favorable effect on the morning surge .
CONCLUSIONS	ClinicalTrials.gov identifier : NCT01830517 .

###24372434
OBJECTIVE	The objective of this study was to evaluate short term and long term efficacy of a transurethral injection ( TUI ) using bulking agent Bulkamid for female stress ( SUI ) and mixed urinary incontinence by women with ISD or where anti-incontinence surgery has failed .
METHODS	Retrospective clinical study .
METHODS	Gynecological and Obstetric Dpt .
METHODS	1st Medical Faculty UK and VFN , Prague .
METHODS	A retrospective study was performed on 52 women with urinary incontinence ( stress , 43 ; mixed 9 ) .
METHODS	One patient died during study .
METHODS	Forty patients had previously undergone anti-incontinence surgery .
METHODS	The efficacy of TUI was evaluated 3 months ( 1 week ) and an average of 22 months after surgery .
METHODS	Subjective assessment of the leakage of urine was based on the International Consultation on Incontinence Questionnaire - Short form ( ICIQ-UI SF ) filled in before , three and - on average - 22 months after the surgery ( minimum time after surgery was 6 months ) .
METHODS	Improvement in urinary incontinence was defined as a drop in the score of more than 50 % .
METHODS	Objective assessment of leakage of urine was assessed by cough test .
METHODS	The cure effect was evaluated by VAS ( Visual Analogue Scale ) score and by using the five-point Likert score .
METHODS	Ethical committee approval was obtained , and all subjects gave written informed consent to participate in the study .
RESULTS	Mean age of patients was 70 years , mean body mass index ( BMI ) 28.65 , and mean parity was 1.76 .
RESULTS	The cough test showed that 19/51 ( 37.3 % ) of patients had negative results for this test 3 months and 10/51 ( 19.6 % ) 22 months after the operation .
RESULTS	The ICIQ-UI SF questionnaire showed that 16/51 ( 31.4 % ) of our patients were completely dry 3 months after the operation and 8/51 ( 15.7 % ) 22 months after the operation .
RESULTS	41/51 ( 80.4 % ) of patients were dry or improved 3 months after the operation and 23/51 ( 45.13 % ) 22 months after the operation .
RESULTS	The mean cure effect evaluated by VAS score 3 months after the operation was 72 and 22 months after the operation it was 51.3 .
RESULTS	The Likert score was 4 or 5 ( cured or improved ) three and 22 months after operation by 78.4 % / 54.9 % patients .
CONCLUSIONS	The cure effect of Bulkamid operation decreases in correlation with the time that elapses after the operation , although this procedure is minimally invasive and is an option in cases where anti-incontinence surgery has failed .

###25881382
BACKGROUND	The purpose of this single blind , prospective , parallel randomized trial study was to compare the effects of face mask and fixed tongue appliance in treatment of Class III malocclusion with maxillary deficiency in growing patients .
METHODS	88 patients with maxillary deficiency were selected .
METHODS	60 fulfilled the study requirements .
METHODS	The patients were randomly assigned to 2 groups by computer generated tables .
METHODS	One group was treated with removable face mask and the other group was treated by fixed tongue appliance .
METHODS	4 of the patients dropped out of study leaving a final number of 56 patients .
METHODS	Thus , the face mask group included 30 patients ( 13 males , 17 females ) with the mean age of 8.5 ( SD 1.4 ) years and the fixed tongue appliance group included 26 patients ( 13 males , 13 females ) with the mean age of 8.9 ( SD 1.7 ) years .
METHODS	The patients Lateral cephalograms obtained at the beginning and end of the study were analyzed .
RESULTS	Paired t-tests showed that SNA increased by 1.3 ( SD 1.1 ) in face mask group ( P < 0.001 ) and it increased by 1.8 ( SD 0.9 ) in fixed tongue appliance group ( P < 0.001 ) .
RESULTS	T-test showed that there were no statistically significant differences between the two groups except for SNB .
RESULTS	IMPA decreased significantly in both groups .
CONCLUSIONS	Both treatment modalities were successful in moving the maxilla forward and improving the profile of the patients ; however , the bulky size of face masks might reduce patients ' compliance and make them less favorite choice of treatment .

###24342385
OBJECTIVE	Although combination pharmacotherapy is common in child and adolescent psychiatry , there has been little research evaluating it .
OBJECTIVE	The value of adding risperidone to concurrent psychostimulant and parent training ( PT ) in behavior management for children with severe aggression was tested .
METHODS	One hundred sixty-eight children 6 to 12 years old ( mean age 8.89 2.01 years ) with severe physical aggression were randomized to a 9-week trial of PT , stimulant ( STIM ) , and placebo ( Basic treatment ; n = 84 ) or PT , STIM , and risperidone ( Augmented treatment ; n = 84 ) .
METHODS	All had diagnoses of attention-deficit/hyperactivity disorder and oppositional-defiant disorder ( n = 124 ) or conduct disorder ( n = 44 ) .
METHODS	Children received psychostimulant ( usually Osmotic Release Oral System methylphenidate ) for 3 weeks , titrated for optimal effect , while parents received PT .
METHODS	If there was room for improvement at the end of week 3 , placebo or risperidone was added .
METHODS	Assessments included parent ratings on the Nisonger Child Behavior Rating Form ( Disruptive-Total subscale was the primary outcome ) and Antisocial Behavior Scale ; blinded clinicians rated change on the Clinical Global Impressions scale .
RESULTS	Compared with Basic treatment ( PT + STIM [ 44.8 14.6 mg/day ] + placebo [ 1.88 mg/day 0.72 ] ) , Augmented treatment ( PT + STIM [ 46.1 16.8 mg/day ] + risperidone [ 1.65 mg/day 0.75 ] ) showed statistically significant improvement onthe Nisonger Child Behavior Rating Form Disruptive-Total subscale ( treatment-by-time interaction , p = .0016 ) , the Nisonger Child Behavior Rating Form Social Competence subscale ( p = .0049 ) , and Antisocial Behavior Scale Reactive Aggression subscale ( p = .01 ) .
RESULTS	Clinical Global Impressions scores weresubstantially improved for the 2 groups but did not discriminate between treatments ( Clinical Global Impressions-Improvement score2 , 70 % forBasic treatment versus 79 % for Augmented treatment ) .
RESULTS	Prolactin elevations and gastrointestinal upset occurred more with Augmented treatment ; other adverse events differed modestly from Basic treatment ; weight gain in the Augmented treatment group was minor .
CONCLUSIONS	Risperidone provided moderate butvariable improvement in aggressive and other seriously disruptive child behaviorswhenadded to PT and optimized stimulant treatment .
CONCLUSIONS	Clinical trial registration information-Treatment of Severe Childhood Aggression ( The TOSCA Study ) , URL : http://clinicaltrials.gov , unique identifier : NCT00796302 .

###24630347
OBJECTIVE	To test the hypothesis that early enteral supplementing fat and fish oil decreases the duration of parenteral nutrition ( PN ) and increases enteral nutrition ( EN ) before bowel reanastomosis in premature infants with an enterostomy .
METHODS	Premature infants ( < 2 months old ) who had an enterostomy and tolerated enteral feeding at 20 mL/kg/day were randomized to usual care ( control = 18 ) or early supplementing enteral fat supplement and fish oil ( treatment = 18 ) .
METHODS	Intravenous lipid was decreased as enteral fat intake was increased .
METHODS	Daily weight , clinical and nutrition data , and weekly length and head circumference were recorded .
METHODS	The primary outcomes were the duration of PN and volume of EN intake , and the secondary outcomes were weight gain ( g/day ) , ostomy output ( mL/kg/d ) , and serum conjugated bilirubin level ( mg/dL ) from initiating feeding to reanastomosis .
METHODS	Data were analyzed by Student t test or Wilcoxon rank sum test .
RESULTS	There were no differences in the duration of PN , ostomy output , and weight gain between the 2 groups before reanastomosis .
RESULTS	However , supplemented infants received less intravenous lipid , had greater EN intake , and lower conjugated bilirubin before reanastomosis , and they also received greater total calorie , had fewer sepsis evaluations and less exposure to antibiotics and central venous catheters before reanastomosis , and had greater weight and length gain after reanastomosis ( all P < .05 ) .
CONCLUSIONS	Early enteral feeding of a fat supplement and fish oil was associated with decreased exposure to intravenous lipid , increased EN intake , and reduced conjugated bilirubin before reanastomosis and improved weight and length gain after reanastomosis in premature infants with an enterostomy .

###25270008
BACKGROUND	Noise-induced hearing loss ( NIHL ) is one of the most common occupational diseases and the second most common cause of workers ' claims for occupational injuries .
OBJECTIVE	Due to high prevalence of NIHL and several reports of improper use of hearing protective devices ( HPDs ) , we conducted this study to compare the effect of face-to-face training in effective use of earplugs with appropriate NRR to overprotection of workers by using earplugs with higher than necessary noise reduction rating ( NRR ) .
METHODS	In a randomized clinical trial , 150 workers referred to occupational medicine clinic were randomly allocated to three arms -- a group wearing earplugs with an NRR of 25 with no training in appropriate use of the device ; a group wearing earplugs with an NRR of 25 with training ; another group wearing earplugs with an NRR of 30 , with no training .
METHODS	Hearing threshold was measured in the study groups by real ear attenuation at threshold ( REAT ) method .
METHODS	This trial is registered with Australian New Zealand clinical trials Registry , number ACTRN00363175 .
RESULTS	The mean SD age of the participants was 28 5 ( range : 19-39 ) years .
RESULTS	42 % of participants were female .
RESULTS	The mean noise attenuation in the group with training was 13.88 dB , significantly higher than those observed in other groups .
RESULTS	The highest attenuation was observed in high frequencies ( 4 , 6 , and 8 kHz ) in the group with training .
CONCLUSIONS	Training in appropriate use of earplugs significantly affects the efficacy of earplugs -- even more than using an earplug with higher NRR .

###24419418
BACKGROUND	The PARAMOUNT phase III trial demonstrated that pemetrexed continuation maintenance significantly reduced the risk of disease progression ( hazard ratio = 0.62 ) and death ( hazard ratio = 0.78 ) versus placebo in patients with advanced nonsquamous non-small-cell lung cancer .
BACKGROUND	To further understand the survival data , descriptive subgroup analyses were undertaken .
METHODS	Nine hundred thirty-nine patients received induction therapy ( four 21-day cycles pemetrexed 500 mg/m and cisplatin 75 mg/m ) , after which 539 nonprogressing patients with an Eastern Cooperative Oncology Group performance status ( PS ) of 0/1 were randomized ( 2:1 ) to maintenance pemetrexed ( 500 mg/m ) cycles or placebo until disease progression .
RESULTS	Baseline characteristics of patients surviving for longer periods were comparable to patients surviving shorter periods , suggesting overall survival ( OS ) benefit for all subgroups of patients on maintenance therapy .
RESULTS	An examination of type and severity of induction adverse events also found no association with survival duration .
RESULTS	Response to induction ( tumor response versus stable disease ) was not determinate of pemetrexed maintenance OS outcome as assessed by waterfall plot and scattergrams and by the distribution of patients among various OS intervals .
RESULTS	The length of the interval before beginning maintenance therapy ( < 7 days versus 7/30 days ) also did not impact the survival results .
RESULTS	PS , a known prognostic factor , was the only baseline characteristic associated with improved OS ; however , both PS 0 and PS 1 patients exhibited a survival benefit from pemetrexed maintenance .
CONCLUSIONS	In PARAMOUNT , the OS benefit was seen across all subgroups .
CONCLUSIONS	Other than PS , no baseline or clinical parameter clearly identified a subgroup more likely to benefit .
CONCLUSIONS	Maintenance treatment decisions should be made on an individual basis .

###25703475
OBJECTIVE	To compare the clinical effects and safety of transepithelial corneal cross-linking ( CXL ) to epithelium-off ( epi-off ) CXL in progressive keratoconus .
METHODS	Randomized clinical trial ( noninferiority ) .
METHODS	Patients received either transepithelial CXL with Ricrolin TE ( n = 35 ) or epi-off CXL with isotonic riboflavin ( n = 26 ) in 1 academic treatment center , using a simple unrestricted randomization procedure .
METHODS	The main outcome measure was clinical stabilization of keratoconus after 1 year , defined as a maximal keratometry ( Kmax ) increase < 1 diopter ( D ) .
RESULTS	Average Kmax was stable at all visits in the transepithelial group , while after epi-off CXL a significant flattening of 1.2-1 .5 D was demonstrated from the 3-month follow-up onwards .
RESULTS	The trend over time in Kmax flattening was significantly different between the groups ( P = .022 ) .
RESULTS	Eight eyes ( 23 % ) in the transepithelial group showed a Kmax increase of > 1 D after 1 year ( range 1.3-5 .4 D ) vs none in the epi-off group ( P = .017 ) .
RESULTS	There was significant different trend in corrected distance visual acuity ( CDVA ) , with a more favorable outcome in the transepithelial group ( P = .023 ) .
RESULTS	In the transepithelial group , no complications occurred and in the epi-off group , 4 eyes ( 15 % ) developed complications owing to healing problems ( sterile infiltrate , herpes keratitis , central haze , and stromal scar ) .
CONCLUSIONS	This study showed that although transepithelial CXL was a safe procedure without epithelial healing problems , 23 % of cases showed a continued keratoconus progression after 1 year .
CONCLUSIONS	Therefore , at this time , we do not recommend replacing epi-off CXL by transepithelial CXL for treatment of progressive keratoconus .

###24875654
BACKGROUND	Cognitive behavioral therapy for insomnia ( CBT-I ) is well-validated in the western countries .
BACKGROUND	However , it has not been widely adopted or disseminated in China .
BACKGROUND	One possibility is that therapeutic approaches drawn from traditional Chinese medicine ( TCM ) will be more widely accepted .
OBJECTIVE	This study aimed to evaluate the efficacy of medication in combination with a therapeutic approach drawn from TCM , Low Resistance Thought Induction Sleep-regulating Technique ( TIP3-2 ) , for acute treatment of insomnia .
METHODS	A randomized controlled trial was conducted .
METHODS	Ninety primary insomnia patients were randomly assigned to receive TIP3-2 combined with medication ( n = 45 ) or medication only ( n = 45 ) for 4 weeks .
METHODS	Medication consisted of 1-2 mg Estazolam nightly .
METHODS	On the basis of taking Estazolam , TIP3-2 combined with medication group was given Low Resistance Thought Induction Sleep-regulating Technique ( TIP3-2 ) treatment twice a week .
METHODS	Outcomes were assessed with the Pittsburgh sleep quality index ( PSQI ) and polysomnography ( PSG ) before and after treatment .
RESULTS	Both groups demonstrated significant improvements in the PSQI and polysomnography indices .
RESULTS	The TIP3-2 + medication group demonstrated a significant difference between the two groups in PSQI total score , sleep medication use , daytime dysfunction , subjective sleep quality , as well as polysomnography indices of sleep efficiency and awakening times ( P < 0.05 ) .
CONCLUSIONS	Among patients with primary insomnia , the addition of TIP3-2 provided benefits above and beyond the role of medication alone .

###25886281
BACKGROUND	Excessive alcohol consumption on single occasions among undergraduate students is a major health issue as research has shown this pattern of drinking to be related to maladaptive health and psychosocial outcomes .
BACKGROUND	Brief , theory-based interventions targeting motivation and self-control as behavior-change techniques have been identified as effective means to reduce alcohol consumption , but few studies have examined the interactive effects of these components .
BACKGROUND	The aim of the present study is to develop a brief theory-based intervention using motivational and self-control intervention techniques to reduce alcohol consumption in undergraduate students .
METHODS	The intervention will adopt a factorial design to test the main and interactive effects of the techniques on alcohol consumption .
METHODS	Using mental simulations and the strength model of self-control as the theoretical bases of the intervention , the study will adopt a fully randomized 2 ( mental simulation : mental simulation vs. control irrelevant visualization exercise ) 2 ( self-control training : challenging Stroop task vs. easy Stroop task ) between-participants design .
METHODS	Non-abstinent undergraduate students aged 18years or older will be eligible to participate in the study .
METHODS	Participants will complete an initial survey including self-reported alcohol consumption measures , measures of motivation and self - measures .
METHODS	Participants will be randomly allocated to receive either a mental simulation exercise presented in print format or a control irrelevant visualization exercise .
METHODS	Thereafter , participants will be randomly assigned to receive a challenging online self-control training exercise or an easy training exercise that has little self-control demand over the course of the next four weeks .
METHODS	Four weeks later participants will complete a follow-up alcohol consumption , motivation and self-control measures .
CONCLUSIONS	This study will provide the first evidence for the individual and interactive effects of motivational and self-control training techniques in an intervention to reduce alcohol consumption .
CONCLUSIONS	It will also demonstrate the importance of adopting multiple theoretical perspectives and a factorial design to identify the unique and interactive impact of behavior-change techniques on health behavior .
BACKGROUND	The trial is registered with the Australian and New Zealand Clinical Trials Registry , ACTRN12613000573752 .

###24486117
OBJECTIVE	Safetac-based soft silicone dressings used in a management setting decrease the severity of radiation-induced acute skin reactions but do not affect moist desquamation rates .
OBJECTIVE	Here we investigate the prophylactic use of another Safetac product , Mepitel Film , on moist desquamation rates .
METHODS	A total of 80 breast cancer patients receiving radiation therapy were recruited between October 2012 and April 2013 ; 78 participants contributed data for analysis .
METHODS	Lateral and medial halves of the skin areas to be irradiated were randomised to Mepitel Film or aqueous cream ; skin dose was measured using thermoluminescent dosimeters ; skin reaction severity was assessed using RISRAS and RTOG scales .
RESULTS	Overall skin reaction severity was reduced by 92 % ( p < 0.0001 ) in favour of Mepitel Film ( RISRAS ) .
RESULTS	All patients developed some form of reaction in cream-treated skin which progressed to moist desquamation in 26 % of patients ( RTOG grades I : 28 % ; IIA : 46 % ; IIB : 18 % ; III : 8 % ) .
RESULTS	Only 44 % of patients had a skin reaction under the Film , which did not progress to moist desquamation in any of the patients ( RTOG grades I : 36 % ; IIA : 8 % ) .
CONCLUSIONS	Mepitel Film completely prevented moist desquamation and reduced skin reaction severity by 92 % when used prophylactically in our cohort .

###24246825
OBJECTIVE	To determine whether the 10-year success rate of penetrating keratoplasty for corneal endothelial disorders is associated with donor age .
METHODS	Multicenter , prospective , double-masked clinical trial .
METHODS	A total of 1090 participants undergoing penetrating keratoplasty at 80 sites for Fuchs ' dystrophy ( 62 % ) , pseudophakic/aphakic corneal edema ( 34 % ) , or another corneal endothelial disorder ( 4 % ) and followed for up to 12 years .
METHODS	Forty-three eye banks provided corneas from donors aged 12 to 75 years , using a randomized approach to assign donor corneas to study participants without respect to recipient factors .
METHODS	Surgery and postoperative care were performed according to the surgeons ' usual routines .
METHODS	Graft failure defined as a regraft or , in the absence of a regraft , a cloudy cornea that was sufficiently opaque to compromise vision for 3 consecutive months .
RESULTS	In the primary analysis , the 10-year success rate was 77 % for 707 corneas from donors aged 12 to 65 years compared with 71 % for 383 donors aged 66 to 75 years ( difference , +6 % ; 95 % confidence interval , -1 to +12 ; P = 0.11 ) .
RESULTS	When analyzed as a continuous variable , higher donor age was associated with lower graft success beyond the first 5 years ( P < 0.001 ) .
RESULTS	Exploring this association further , we observed that the 10-year success rate was relatively constant for donors aged 34 to 71 years ( 75 % ) .
RESULTS	The success rate was higher for 80 donors aged 12 to 33 years ( 96 % ) and lower for 130 donors aged 72 to 75 years ( 62 % ) .
RESULTS	The relative decrease in the success rate with donor ages 72 to 75 years was not observed until after year 6 .
CONCLUSIONS	Although the primary analysis did not show a significant difference in 10-year success rates comparing donor ages 12 to 65 years and 66 to 75 years , there was evidence of a donor age effect at the extremes of the age range .
CONCLUSIONS	Because we observed a fairly constant 10-year success rate for donors aged 34 to 71 years , which account for approximately 75 % of corneas in the United States available for transplant , the Cornea Donor Study results indicate that donor age is not an important factor in most penetrating keratoplasties for endothelial disease .

###26018333
OBJECTIVE	Perimenopause is accompanied by an increased risk of new and recurrent depression .
OBJECTIVE	The coincidence of declining ovarian function with the onset of depression led to the inference that `` withdrawal '' from physiologic estradiol levels underpinned depression in perimenopause .
OBJECTIVE	To our knowledge , this is the first controlled systematic study to directly test the estrogen withdrawal theory of perimenopausal depression ( PMD ) .
OBJECTIVE	To examine the role of estradiol withdrawal in PMD .
METHODS	Initial open-label treatment with estradiol followed by randomized , double-blind , placebo-controlled , parallel-design evaluation of continued estradiol treatment was evaluated at an outpatient research facility at the National Institutes of Health Clinical Center .
METHODS	An intent-to-treat analysis was performed between October 2003 and July 2012 .
METHODS	Participants included asymptomatic postmenopausal women with past PMD responsive to hormone therapy ( n = 26 ) and asymptomatic postmenopausal women with no history of depression ( n = 30 ) matched for age , body mass index , and reproductive status who served as controls .
METHODS	Data were analyzed between November 2012 and October 2013 by repeated-measures analysis of variance .
METHODS	After 3 weeks of open-label administration of transdermal estradiol ( 100 g/d ) , participants were randomized to a parallel design to receive either estradiol ( 100 g/d ; 27 participants ) or matched placebo skin patches ( 29 participants ) for 3 additional weeks under double-blind conditions .
METHODS	Center for Epidemiologic Studies-Depression Scale and 17-item Hamilton Depression Rating Scale ( completed by raters blind to diagnosis and randomization status ) , self-administered visual analog symptom ratings , and blood hormone levels obtained at weekly clinic visits .
RESULTS	None of the women reported depressive symptoms during open-label use of estradiol .
RESULTS	Women with past PMD who were crossed over from estradiol to placebo experienced a significant increase in depression symptom severity demonstrated using the Center for Epidemiologic Studies-Depression Scale and 17-item Hamilton Depression Rating Scale , with mean ( SD ) scores increasing from estradiol ( ie , 2.4 [ 2.0 ] and 3.0 [ 2.5 ] ) to placebo ( 8.8 [ 4.9 ] and 6.6 [ 4.5 ] , respectively [ P = .0004 for both ] ) .
RESULTS	Women with past PMD who continued estradiol therapy and all women in the control group remained asymptomatic .
RESULTS	Women in both groups had similar hot-flush severity and plasma estradiol levels during use of placebo .
CONCLUSIONS	In women with past PMD that was previously responsive to hormone therapy , the recurrence of depressive symptoms during blinded hormone withdrawal suggests that normal changes in ovarian estradiol secretion can trigger an abnormal behavioral state in these susceptible women .
CONCLUSIONS	Women with a history of PMD should be alert to the risk of recurrent depression when discontinuing hormone therapy .
BACKGROUND	clinicaltrials.gov Identifier : NCT00060736 .

###24938504
BACKGROUND	Most persons with dementia live at home and are treated in the primary care .
BACKGROUND	However , the ambulatory health care system in Germany contains a lot of `` interface problems '' and is not optimized for the future challenges .
BACKGROUND	Innovative concepts like regional networks in dementia care exist on a project level and need to be tested for efficacy to encourage implementation .
BACKGROUND	The goal of the study is the scientific evaluation of an already existing regional dementia network .
METHODS	Prospective randomized controlled trial of 235 community-living elderly with dementia and their family caregivers of network treatment ( n = 117 ) compared to usual care ( n = 118 ) in a predominantly rural region .
METHODS	The allocation to intervention or control group was based on network membership of their General Practitioner .
METHODS	Intervention patients received diagnostic evaluation and subsequent treatment according to network guidelines .
METHODS	Main outcome measures were the early contact with a neurologic or psychiatric specialist and dementia-specific medication as well as quality of life of the patients , and as secondary outcomes caregiver burden and caregiver health-related quality of life .
RESULTS	Network patients were more likely to receive antidementive drugs ( 50.5 % vs. 35.8 % ; p = 0.035 ) and had more often contact to a neurologist ( 18.6 % vs. 2.8 % ; p < 0.001 ) .
RESULTS	No group differences were found on patient 's quality of life nor overall effects or treatment by time effects .
RESULTS	Intervention caregivers reported no significant improvements in health related quality of life measured by SF-36 and EQ-5D .
CONCLUSIONS	The management of dementia patients in an interdisciplinary regional network solelyprovides measurable advantages with respect to the provision of dementia-specific medication and utilization of medical treatment i.e. referral rates to specialists .
CONCLUSIONS	Further evaluation research is needed to identify relevant mechanismsof collaborative processes with respect to their impact on patient and caregiver related outcomes .

###25155966
OBJECTIVE	To evaluate the efficacy and safety of enteral recombinant human granulocyte colony-stimulating factor ( rhG-CSF ) and recombinant human erythropoietin ( rhEPO ) in preventing feeding intolerance .
METHODS	An interventional randomized control trial was conducted in 90 preterm infants born at 33 weeks gestational age .
METHODS	The neonates were assigned to 4 groups ; 20 received rhG-CSF , 20 received rhEPO , 20 received both , and 30 received distilled water ( placebo control ) .
METHODS	The test solution was given at the beginning of enteral feeding and was discontinued when enteral intake reached 100 mL/kg/day or after a maximum of 7 days , whichever came first .
METHODS	Feeding tolerance and adverse effects of treatment were assessed .
METHODS	Serum granulocyte colony-stimulating factor and erythropoietin levels were measured on days 0 and 7 of treatment .
RESULTS	All neonates tolerated the treatment without side effects .
RESULTS	Neonates who received rhG-CSF and/or rhEPO had better feeding tolerance , as reflected by earlier achievement of 75 mL/kg/day , 100 mL/kg/day , and full enteral feeding of 150 mL/kg/day with earlier weight gain and a shorter hospital stay ( P < .05 ) .
RESULTS	The risk of necrotizing enterocolitis was reduced from 10 % to 0 % in all treatment groups ( P < .05 ) .
RESULTS	There was a shorter duration of withholding of feeding secondary to feeding intolerance among neonates receiving both rhG-CSF and rhEPO compared with those receiving placebo ( P < .05 ) .
RESULTS	Serum levels of granulocyte colony-stimulating factor and erythropoietin at 0 and 7 days did not differ across the treatment groups .
CONCLUSIONS	Enteral administration of rhG-CSF and/or rhEPO improves feeding outcome and decreases the risk of necrotizing enterocolitis in preterm neonates .
CONCLUSIONS	The mechanism may involve the prevention of villous atrophy .

###24879965
OBJECTIVE	To evaluate the effects of whole-body resistance training on exercise capacity , health-related quality of life ( HRQOL ) , and muscle strength in patients hospitalized for exacerbation of chronic obstructive pulmonary disease .
METHODS	Randomized controlled trial .
METHODS	University hospital .
METHODS	Patients ( N = 46 ) were randomized to either a control group ( CG ) or training group ( TG ) , and 29 patients completed the study .
METHODS	Training consisted of weight-lifting exercises for 6 muscle groups in the upper and lower limbs ( 2 sets of 8 repetitions each ) , and the initial load was set at 80 % of the 1-repetition maximum load .
METHODS	Patients were evaluated on the second day of hospitalization , at hospital discharge , and 30 days postdischarge .
METHODS	Patients were evaluated on the basis of the 6-minute walking distance ( 6MWD ) , HRQOL , muscle strength , systemic inflammatory markers , and level of physical activity in daily life ( PADL ) .
RESULTS	The CG showed a reduction in the strength of lower-limb muscles ( P < .05 ) but not in the 6MWD ( P > .05 ) .
RESULTS	In contrast , patients from the TG improved strength in the lower-limb muscles and 6MWD during and 30 days after hospitalization ( P < .05 ) .
RESULTS	The TG also improved the impact domain in HRQOL after hospitalization .
RESULTS	No improvement in PADL was observed in the TG .
RESULTS	Finally , a reduction in the blood levels of inflammatory markers was observed only in the TG after hospitalization .
CONCLUSIONS	Our results suggest that resistance training during hospitalization improves the 6MWD , HRQOL , and lower-limb muscle strength , without altering the levels of systemic inflammation .
CONCLUSIONS	However , future research should explore this intervention in larger randomized trials .

###24970786
BACKGROUND	Neoadjuvant hormonal therapy ( NHT ) is playing an increasing role in the clinical management of breast cancer ( BC ) and may improve surgical outcomes for postmenopausal , oestrogen receptor ( ER ) - positive BC patients .
BACKGROUND	However , there is currently no consensus on the optimal duration of NHT before surgery .
BACKGROUND	Here , we present the outcomes of the TEAM IIA trial , a multicentre , phase II trial investigating the efficacy of six months of neoadjuvant exemestane in postmenopausal , strong ER-positive ( ER + , 50 % ) BC patients .
METHODS	102 patients ( stage T2-T4ac ) were included in the study after exclusion of ineligible patients .
METHODS	Primary end-point was clinical response at 3 and 6 months as measured by palpation .
METHODS	Secondary end-point was radiological response as measured by magnetic resonance imaging ( MRI ) , mammography and/or ultrasound .
METHODS	Linear mixed models ( 95 % confidence interval ( CI ) ) were used to compare changes in mean tumour size ( in mm ) between baseline , 3 and 6 months after the start of endocrine therapy .
METHODS	Conversion rates from mastectomy to breast conserving surgery ( BCS ) were evaluated .
RESULTS	Median age of all patients was 72 years ( range 53-88 ) .
RESULTS	Overall response rate by clinical palpation was 64.5 % in all patients with a final palpation measurement .
RESULTS	Four patients had clinically progressive disease .
RESULTS	63 patients had both 3-month and > 3-month palpation measurements .
RESULTS	Overall response was 58.7 % at 3 months and 68.3 % at final palpation ( > 3 months ) .
RESULTS	Mean tumour size by clinical palpation at T = 0 was 39.1 mm ( 95 % CI 34.8-43 .4 mm ) , and decreased to 23.0 mm ( 95 % CI 18.7-27 .2 mm ) and 16.7 mm ( 95 % CI 12.6-20 .8 ) at T = 3 and T > 3 months , respectively ( p = 0.001 ) .
RESULTS	Final radiological response rates at the end of treatment for MRI ( n = 37 ) , ultrasound ( n = 77 ) and mammography ( n = 56 ) were 70.3 % , 41.6 % and 48.2 % , respectively .
RESULTS	Feasibility of BCS improved from 61.8 % to 70.6 % ( McNemar p = 0.012 ) .
CONCLUSIONS	6 months of neoadjuvant exemestane therapy helps reduce mean tumour size further in strongly ER-positive BC patients without significant side-effects compared to 3 months .
CONCLUSIONS	Nevertheless , some patients still experience disease progression under exemestane .
CONCLUSIONS	Feasibility of breast conservation rates improved by almost 10 % .

###24622413
BACKGROUND	Hypoparathyroidism results in impaired mineral homoeostasis , including hypocalcaemia and hyperphosphataemia .
BACKGROUND	Treatment with high-dose oral calcium and active vitamin D does not provide adequate or consistent control of biochemical indices and can lead to serious long-term complications .
BACKGROUND	We aimed to test the efficacy , safety , and tolerability of once-daily recombinant human parathyroid hormone 1-84 ( rhPTH [ 1-84 ] ) in adults with hypoparathyroidism .
METHODS	In this double-blind , placebo-controlled , randomised phase 3 study ( REPLACE ) , we recruited patients with hypoparathyroidism ( 18 months duration ) aged 18-85 years from 33 sites in eight countries .
METHODS	After an optimisation period , during which calcium and active vitamin D doses were adjusted to achieve consistent albumin-corrected serum calcium , patients were randomly assigned ( 2:1 ) via an interactive voice response system to 50 g per day of rhPTH ( 1-84 ) or placebo for 24 weeks .
METHODS	Active vitamin D and calcium were progressively reduced , while rhPTH ( 1-84 ) could be titrated up from 50 g to 75 g and then 100 g ( weeks 0-5 ) .
METHODS	The primary endpoint was the proportion of patients at week 24 who achieved a 50 % or greater reduction from baseline in their daily dose of oral calcium and active vitamin D while maintaining a serum calcium concentration greater than or the same as baseline concentrations and less than or equal to the upper limit of normal , analysed by intention to treat .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00732615 .
RESULTS	Between June 23 , 2009 , and Feb 28 , 2011 , 134 eligible patients were recruited and randomly assigned to rhPTH ( 1-84 ) ( n = 90 ) or placebo ( n = 44 ) .
RESULTS	Six patients in the rhPTH ( 1-84 ) group and seven in the placebo group discontinued before study end .
RESULTS	48 ( 53 % ) patients in the rhPTH ( 1-84 ) group achieved the primary endpoint compared with one ( 2 % ) patient in the placebo group ( percentage difference 51.1 % , 95 % CI 39.9-62 .3 ; p < 0.0001 ) .
RESULTS	The proportions of patients who had at least one adverse event were similar between groups ( 84 [ 93 % ] patients in the rhPTH [ 1-84 ] group vs 44 [ 100 % ] patients in the placebo group ) , with hypocalcaemia , muscle spasm , paraesthesias , headache , and nausea being the most common adverse events .
RESULTS	The proportions of patients with serious adverse events were also similar between the rhPTH ( 1-84 ) group ( ten [ 11 % ] patients ) and the placebo group ( four [ 9 % ] patients ) .
CONCLUSIONS	50 g , 75 g , or 100 g per day of rhPTH ( 1-84 ) , administered subcutaneously in the outpatient setting , is efficacious and well tolerated as a PTH replacement therapy for patients with hypoparathyroidism .

###25892646
BACKGROUND	Second line endocrine therapy has limited antitumour activity .
BACKGROUND	Fulvestrant inhibits and downregulates the oestrogen receptor .
BACKGROUND	The mitogen-activated protein kinase ( MAPK ) pathway is one of the major cascades involved in resistance to endocrine therapy .
BACKGROUND	We assessed the efficacy and safety of fulvestrant with selumetinib , a MEK 1/2 inhibitor , in advanced stage breast cancer progressing after aromatase inhibitor ( AI ) .
METHODS	This randomised phase II trial included postmenopausal patients with endocrine-sensitive breast cancer .
METHODS	They were ramdomised to fulvestrant combined with selumetinib or placebo .
METHODS	The primary endpoint was disease control rate ( DCR ) in the experimental arm .
METHODS	ClinicalTrials.gov Indentifier : NCT01160718 .
RESULTS	Following the planned interim efficacy analysis , recruitment was interrupted after the inclusion of 46 patients ( 23 in each arm ) , because the selumetinib-fulvestrant arm did not reach the pre-specified DCR .
RESULTS	DCR was 23 % ( 95 % confidence interval ( CI ) 8-45 % ) in the selumetinib arm and 50 % ( 95 % CI 27-75 % ) in the placebo arm .
RESULTS	Median progression-free survival was 3.7 months ( 95 % CI 1.9-5 .8 ) in the selumetinib arm and 5.6 months ( 95 % CI 3.4-13 .6 ) in the placebo arm .
RESULTS	Median time to treatment failure was 5.1 ( 95 % CI 2.3-6 .7 ) and 5.6 ( 95 % CI 3.4-10 .2 ) months , respectively .
RESULTS	The most frequent treatment-related adverse events observed in the selumetinib-fulvestrant arm were skin disorders , fatigue , nausea/vomiting , oedema , diarrhoea , mouth disorders and muscle disorders .
CONCLUSIONS	The addition of selumetinib to fulvestrant did not show improving patients ' outcome and was poorly tolerated at the recommended monotherapy dose .
CONCLUSIONS	Selumetinib may have deteriorated the efficacy of the endocrine therapy in some patients .

###24598948
BACKGROUND	Biochemical markers of myocardial injury are frequently altered after cardiac surgery .
BACKGROUND	So far there is no evidence whether oral beta-blockers may reduce myocardial injury after coronary artery bypass grafting .
OBJECTIVE	To determine if oral administration of prophylactic metoprolol reduces the release of cardiac troponin I in isolated coronary artery bypass grafting , not complicated by new Q waves .
METHODS	A prospective randomized study , including 68 patients , divided in 2 groups : Group A ( n = 33 , control ) and B ( n = 35 , beta-blockers ) .
METHODS	In group B , metoprolol tartrate was administered 200 mg/day .
METHODS	The myocardial injury was assessed by troponin I with 1 hour and 12 hours after coronary artery bypass grafting .
RESULTS	No significant difference between groups regarding pre-surgical , surgical , complication in intensive care ( 15 % versus 14 % , P = 0.92 ) and the total number of hospital events ( 21 % versus 14 % , P = 0.45 ) was observed .
RESULTS	The median value of troponin I with 12 hours in the study population was 3.3 ng/ml and was lower in group B than in group A ( 2.5 ng/ml versus 3.7 ng/ml , P < 0,05 ) .
RESULTS	In the multivariate analysis , the variables that have shown to be independent predictors of troponin I release after 12 hours were : no beta-blockers administration and number of vessels treated .
CONCLUSIONS	The results of this study in uncomplicated coronary artery bypass grafting , comparing the postoperative release of troponin I at 12 hours between the control group and who used oral prophylactic metoprolol for at least 72 hours , allow to conclude that there was less myocardial injury in the betablocker group , giving some degree of myocardial protection .

###24523413
BACKGROUND	The purpose of this study was to compare the efficacy of radiofrequency catheter ablation ( RFCA ) versus antiarrhythmic drugs ( AADs ) for treatment of patients with frequent ventricular premature beats ( VPBs ) originating from the right ventricular outflow tract ( RVOT ) .
RESULTS	A total of 330 eligible patients were included in the study and were randomly assigned to RFCA or AADs group .
RESULTS	The absolute number and the burden of VPBs on 12-lead Holter monitors were measured at baseline and at 1st , 3rd , 6th , and 12th months after randomization .
RESULTS	Left ventricular eject fraction was evaluated by transthoracic echocardiogram at baseline and at 3 and 6 months after randomization .
RESULTS	During the 1-year follow-up period , VPB recurrence was significantly lower in patients randomized to RFCA group ( 32 patients , 19.4 % ) versus AADs group ( 146 patients , 88.6 % ; P < 0.001 , log-rank test ) .
RESULTS	In a Poisson generalized estimating equations ( GEE ) regression model , RFCA was associated with a greater decrease in the burden of VPBs ( incidence rate ratio 0.105 ; 95 % confidence intervals [ 0.104-0 .105 ] ; P < 0.001 ) compared with AADs .
RESULTS	In a liner GEE model , the left ventricular eject fraction had a tendency to increase after the treatment in both groups ( coefficient , 0.584 ; 95 % confidence intervals [ 0.467-0 .702 ] ; P < 0.001 ) .
RESULTS	In a Cox proportional model , the QS morphology in lead I was the only predictor of VPB recurrence free for catheter ablation ( hazards ratio , 0.154 ; 95 % confidence intervals [ 0.044-0 .543 ] ; P = 0.004 ) .
CONCLUSIONS	Catheter ablation is more efficacious than AADs for preventing VPB recurrence in patients with frequent VPBs originating from the RVOT .
CONCLUSIONS	QS morphology in lead I was associated with better outcome after ablation .

###25413567
BACKGROUND	Although there is no direct evidence , it is generally believed that bed rest shifts the haemostatic system towards hypercoagulability ; thus , immobilized patients are commonly treated with anticoagulants .
BACKGROUND	We therefore aimed to investigate whether long-term bed rest actually leads to an elevated risk for thromboembolic events .
METHODS	Eleven healthy men were enrolled in our study ( bed rest campaign in MEDES Clinique d'Investigation , Toulouse , France ) .
METHODS	Besides various standard laboratory methods , we used calibrated automated thrombography ( CAT ) and thrombelastometry ( TEM ) .
METHODS	Activation of samples with minute amounts of relipidated tissue factor allowed sensitive detection of hyper - or hypocoagulable states .
RESULTS	CAT and TEM values were not indicative of bed rest-induced hypercoagulability .
RESULTS	On the contrary , several parameters were indicative of a tendency towards a hypocoagulable state .
RESULTS	Peak and thrombin formation velocity ( VELINDEX ) were significantly decreased during bed rest compared to baseline .
RESULTS	Coagulation times were significantly increased and alpha angles were significantly decreased , indicating attenuated clot formation .
RESULTS	Moreover , F1 +2 and thrombin/antithrombin complex ( TAT ) values were significantly decreased during bed rest , indicating suppressed coagulation activation .
RESULTS	FVII plasma levels were also significantly decreased during the first week of bed rest .
CONCLUSIONS	Our data indicate that the re-ambulation period is associated with a tendency towards hypercoagulability : ttPeak and StartTail were significantly shorter , Peak and VELINDEX were significantly higher compared to baseline .
CONCLUSIONS	Moreover , plasma levels of F1 +2 , TAT , FVII and FVIII were significantly higher compared to baseline .
CONCLUSIONS	The results from our study suggest that bed rest by itself is not associated with hypercoagulable states in healthy subjects .

###24783221
BACKGROUND	Specific immunotherapy ( SIT ) with an ultrarush administration schedule with Purethal for tree pollen allergens has been evaluated to assess its efficacy and safety .
METHODS	The study group consisted of 22 patients with symptoms of allergic rhinitis and confirmed allergy to tree pollens .
METHODS	Patients were randomized and given an administration schedule of either ultrarush therapy or conventional preseasonal SIT .
METHODS	Treatment was performed during three consecutive years .
RESULTS	After three years of treatment , a similar reduction in nasal symptoms was observed ; according to the visual analog scale , there was a decrease from 3.991 0.804 points to 1.634 0.540 in the ultrarush group and from 3.845 0.265 to 1.501 0.418 in the group desensitized using the conventional method ( P > 0.05 ) .
RESULTS	There was also a comparable reduction in the use of relief drugs during pollen season and an increase in the serum concentration of IgG4 to tree pollens .
RESULTS	No significant differences in the safety profile were observed .
CONCLUSIONS	An administration schedule of ultrarush SIT with Purethal Trees is a safe treatment in preliminary observations .
CONCLUSIONS	This therapy is comparable with conventional administration of SIT in the field of efficacy and safety .

###24456057
OBJECTIVE	To evaluate the feasibility and safety of utilizing a commercially available virtual reality gaming system as a treatment intervention for balance training .
METHODS	A randomized controlled trial in which assessment and analysis were blinded .
METHODS	An inpatient rehabilitation facility .
METHODS	Interventions included balance-based physical therapy using a Nintendo Wii , as monitored by a physical therapist , and receipt of one-on-one balance-based physical therapy using standard physical therapy modalities available for use in the therapy gym .
RESULTS	Participants in the standard physical therapy group were found to have slightly higher enjoyment at mid-intervention , while those receiving the virtual reality-based balance intervention were found to have higher enjoyment at study completion .
RESULTS	Both groups demonstrated improved static and dynamic balance over the course of the study , with no significant differences between groups .
RESULTS	Correlational analyses suggest a relationship exists between Wii balance board game scores and BBS scores for measures taken beyond the baseline assessment .
CONCLUSIONS	This study provides a modest level of evidence to support using commercially available VR gaming systems for the treatment of balance deficits in patients with a primary diagnosis of TBI receiving inpatient rehabilitation .
CONCLUSIONS	Additional research of these types of interventions for the treatment of balance deficits is warranted .

###25332486
BACKGROUND	Monitoring of fruit and vegetable ( F&V ) intake is fraught with difficulties .
BACKGROUND	Available dietary assessment methods are associated with considerable error , and the use of biomarkers offers an attractive alternative .
BACKGROUND	Few studies to date have examined the use of plasma biomarkers to monitor or predict the F&V intake of volunteers consuming a wide range of intakes from both habitual F&V and manipulated diets .
OBJECTIVE	This study tested the hypothesis that an integrated biomarker calculated from a combination of plasma vitamin C , cholesterol-adjusted carotenoid concentration and Ferric Reducing Antioxidant Power ( FRAP ) had more power to predict F&V intake than each individual biomarker .
METHODS	Data from a randomized controlled dietary intervention study [ FLAVURS ( Flavonoids University of Reading Study ) ; n = 154 ] in which the test groups observed sequential increases of 2.3 , 3.2 , and 4.2 portions of F&V s every 6 wk across an 18-wk period were used in this study .
RESULTS	An integrated plasma biomarker was devised that included plasma vitamin C , total cholesterol-adjusted carotenoids , and FRAP values , which better correlated with F&V intake ( r = 0.47 , P < 0.001 ) than the individual biomarkers ( r = 0.33 , P < 0.01 ; r = 0.37 , P < 0.001 ; and r = 0.14 , respectively ; P = 0.099 ) .
RESULTS	Inclusion of urinary potassium concentration did not significantly improve the correlation .
RESULTS	The integrated plasma biomarker predicted F&V intake more accurately than did plasma total cholesterol-adjusted carotenoid concentration , with the difference being significant at visit 2 ( P < 0.001 ) and with a tendency to be significant at visit 1 ( P = 0.07 ) .
CONCLUSIONS	Either plasma total cholesterol-adjusted carotenoid concentration or the integrated biomarker could be used to distinguish between high - and moderate-F & V consumers .
CONCLUSIONS	This trial was registered at www.controlled-trials.com as ISRCTN47748735 .

###24322483
BACKGROUND	Nearly 2 % of youths suffer from chronic migraine or chronic tension-type headache ( CTTH ) .
BACKGROUND	A contributing factor in approximately 20 % -50 % of these youths is medication overuse , which involves taking analgesics three or more times per week for three months .
BACKGROUND	The objective of this study was to test motivational interviewing ( MI ) as an approach to promote adherence to recommendations regarding not only analgesic overuse but also other aspects of treatment plans .
METHODS	A randomized controlled trial was conducted comparing the experimental condition ( standard of care clinic-based treatment with supplemental MI phone calls ; N = 24 ) to a control condition ( standard of care clinic-based treatment without these supplemental MI phone calls ; N = 23 ) .
METHODS	Four months after enrollment , a research assistant who was blinded to study condition telephoned adolescents inquiring about headache frequency , headache severity , and disability .
RESULTS	Headache frequency was lower in the experimental condition versus control condition for those with relatively lower initial levels of headache frequency .
RESULTS	In contrast , we did not find greater improvement in headache severity and disability for the experimental condition relative to the control condition .
CONCLUSIONS	Our findings provided some preliminary , albeit limited , support for MI as an approach to improve outcomes for adolescent medication-overuse headache ( MOH ) .

###25138273
BACKGROUND	Single-injection transversus abdominis plane ( TAP ) block provides postoperative analgesia and decreases supplemental analgesic requirements .
BACKGROUND	However , there is currently no evidence from randomized , controlled studies investigating the possible benefits of continuous TAP blocks .
BACKGROUND	Therefore , the aim of this randomized , triple-masked , placebo-controlled study was to determine if benefits are afforded by adding a multiple-day , ambulatory , continuous ropivacaine TAP block to a single-injection block following hernia surgery .
METHODS	Preoperatively , subjects undergoing unilateral inguinal ( N = 19 ) or peri-umbilical ( N = 1 ) hernia surgery received unilateral or bilateral TAP perineural catheter ( s ) , respectively .
METHODS	All received a ropivacaine 0.5 % ( 20 mL ) bolus via the catheter ( s ) .
METHODS	Subjects were randomized to either postoperative perineural ropivacaine 0.2 % or normal saline using portable infusion pump ( s ) .
METHODS	Subjects were discharged home where the catheter ( s ) were removed the evening of postoperative day ( POD ) 2 .
METHODS	Subjects were contacted on POD 0-3 .
METHODS	The primary endpoint was average pain with movement ( scale : 0-10 ) queried on POD 1 .
RESULTS	Twenty subjects of a target 30 were enrolled due to the primary surgeon 's unanticipated departure from the institution .
RESULTS	Average pain queried on POD 1 for subjects receiving ropivacaine ( N = 10 ) was a mean ( standard deviation ) of 3.0 ( 2.6 ) vs 2.8 ( 2.7 ) for subjects receiving saline ( N = 10 ; 95 % confidence interval difference in means -2.9 to 3.4 ; P = 0.86 ) .
RESULTS	There were no statistically significant differences detected between treatment groups in any secondary endpoint .
CONCLUSIONS	The results of this study do not support adding an ambulatory , continuous ropivacaine infusion to a single-injection ropivacaine TAP block for hernia surgery .
CONCLUSIONS	However , the present investigation was underpowered , and further study is warranted .

###26289681
OBJECTIVE	To determine whether prescription opioid use is associated with higher dementia risk or greater cognitive decline .
METHODS	Prospective cohort study .
METHODS	Group Health , an integrated healthcare delivery system .
METHODS	Community-dwelling individuals aged 65 and older without dementia with at least 10 years of Group Health enrollment at baseline ( N = 3,434 ; median age 74 ) .
METHODS	The Cognitive Abilities Screening Instrument ( CASI ) was administered every 2 years .
METHODS	Low scores triggered detailed evaluation , and a multidisciplinary committee assigned dementia diagnoses .
METHODS	From computerized pharmacy data , cumulative opioid exposure was defined as total standardized doses ( TSDs ) dispensed over 10 years ( excluding the most recent year because of possible prodromal symptoms ) .
METHODS	For comparison , use of nonsteroidal anti-inflammatory drugs ( NSAIDs ) , characterized similarly , was examined .
METHODS	Dementia risk was analyzed using Cox proportional hazards models and CASI trajectory using linear regression models and generalized estimating equations .
RESULTS	Seven hundred ninety-seven participants ( 23 % ) developed dementia over a mean follow-up of 7.3 years ; 637 ( 19 % ) had possible or probable Alzheimer 's disease .
RESULTS	For cumulative opioid use , the hazard ratios ( HRs ) for dementia were 1.06 ( 95 % confidence interval ( CI ) = 0.88-1 .26 ) for 11 to 30 TSDs , 0.88 ( 95 % CI = 0.70-1 .09 ) for 31 to 90 TSDs , and 1.29 ( 95 % CI = 1.02-1 .62 ) for 91 or more TSDs , versus 0 to 10 TSDs .
RESULTS	A similar pattern was seen for NSAID use .
RESULTS	Heavier opioid use was not associated with more-rapid cognitive decline .
CONCLUSIONS	People with the heaviest opioid or NSAID use had slightly higher dementia risk than people with little or no use .
CONCLUSIONS	These results may reflect an effect of chronic pain on cognition or residual confounding .
CONCLUSIONS	Although opioids have other risks , little evidence of long-term cognitive harm specific to opioids was found .

###25541389
BACKGROUND	Repetitive transcranial magnetic stimulation ( rTMS ) of the dorsolateral-prefrontal cortex ( DLPFC ) with conventional figure-of-8 ( = butterfly ) coils has been used as an antidepressant therapeutic tool for almost twenty years .
BACKGROUND	Very recently , an innovative rTMS coil , the so-called double cone coil ( DC ) , was introduced allowing the modulation of the anterior cingulate cortex ( AC ) .
BACKGROUND	We investigated safety and therapeutic effectiveness of this stimulation in a naturalistic clinical setting .
METHODS	Forty-five patients suffering a moderate to severe depressive episode were randomized to receive 15 sessions of either conventional rTMS of the left DLPFC ( `` butterfly-rTMS '' ; 10Hz ; 2000 stimuli/day , RMT 110 % ) , mediofrontal double cone coil stimulation of the anterior cingulate cortex ( `` ACDC-rTMS '' with equal parameters ) , or sham-stimulation .
METHODS	The primary outcome was the change in the 21-items Hamilton Rating Scale for Depression ( HAMD ) from baseline to the end of treatment .
METHODS	Secondary outcome measures were changes over the course of the trial regarding the HAMD , the Beck Depression Inventory ( BDI ) , the Clinical Global Impression ( CGI ) and the Global Assessment of Functioning ( GAF ) scales .
RESULTS	There was a significant grouptime interaction effect regarding the primary outcome ( F = 3.269 ; df = 2,37 ; P = 0.049 ) .
RESULTS	Post-hoc t-testing revealed a significant effect for the comparison ACDC vs. butterfly at week 3/end of treatment ( T = 2.646 ; df = 26 ; P = 0.014 ) .
RESULTS	No severe adverse events occurred during the study .
RESULTS	ACDC-stimulation was well tolerated by the majority of patients similar like butterfly-rTMS and sham-stimulation .
CONCLUSIONS	This pilot study demonstrated the feasibility of ACDC-rTMS-stimulation as an add-on-treatment for depression .
CONCLUSIONS	Its clinical effects warrant further investigation in the future .

###24907873
BACKGROUND	The duration of the spinal block is a concern for anesthetists .
BACKGROUND	Low dose intrathecal lidocaine has vasodilatory effects and increases the local anesthetic clearance from the intrathecal space .
BACKGROUND	The aim was to investigate whether this effect of lidocaine can be used to increase the resolution of levobupivacaine spinal anesthesia .
METHODS	After obtaining ethical approval and informed patient consent , 40 patients underwent transurethral prostate resection were studied .
METHODS	Patients were randomized into two groups and patients received either levobupivacaine 6.75 mg + 0.3 mL 2 % lidocaine ( Group L ) or levobupivacaine 6.75 mg + saline ( Group C ) .
METHODS	The main outcome measures were the difference between groups regarding the duration of the spinal block and PACU stay .
METHODS	Secondary outcome measures were the difference between groups in onset and resolution of the spinal block , adverse events and treatments were also investigated .
RESULTS	Spinal block resolved faster in Group L than Group C ; 162.4339.4 min vs 219.73 37.3 min ( p = 0.000 ) .
RESULTS	PACU time was shorter in Group L ( 109 49.9 min in Group L vs 148 56.8 min in Group C ) ( p = 0.036 ) .
RESULTS	There was no difference between groups with respect to the incidence of adverse events and treatments .
RESULTS	Groups were also similar regarding complications .
RESULTS	PDPH and TNS were not observed in any group .
CONCLUSIONS	Addition of low dose lidocaine to hyperbaric levobupivacaine reduces the duration of the intrathecal block provided by hyperbaric levobupivacaine .
CONCLUSIONS	This technique can be used to reduce the spinal block duration for relatively short procedures like TUR-P .

###25844993
OBJECTIVE	Brain injury affects neurologic function and quality of life in survivors after cardiac arrest .
OBJECTIVE	To compare the effects of 2 target temperature regimens on long-term cognitive function and quality of life after cardiac arrest .
METHODS	In this multicenter , international , parallel group , assessor-masked randomized clinical trial performed from November 11 , 2010 , through January 10 , 2013 , we enrolled 950 unconscious adults with cardiac arrest of presumed cardiac cause from 36 intensive care units in Europe and Australia .
METHODS	Eleven patients were excluded from analysis for a total sample size of 939 .
METHODS	Targeted temperature management at 33C vs 36C .
METHODS	Cognitive function was measured by the Mini-Mental State Examination ( MMSE ) and assessed by observers through the Informant Questionnaire on Cognitive Decline in the Elderly ( IQCODE ) .
METHODS	Patients reported their activities in daily life and mental recovery through Two Simple Questions and their quality of life through the Medical Outcomes Study 36-Item Short Form Health Survey , version 2 .
RESULTS	In the modified intent-to-treat population , including nonsurvivors , the median MMSE score was 14 in the 33C group ( interquartile range [ IQR ] , 0-28 ) vs 17 in the 36C group ( IQR , 0-29 ) ( P = .77 ) , and the IQCODE score was 115 ( IQR , 79-130 ) vs 115 ( IQR , 80-130 ) ( P = .57 ) in the 33C and 36C groups , respectively .
RESULTS	The median MMSE score for survivors was within the reference range and similar ( 33C group median , 28 ; IQR , 26-30 ; vs 36C group median , 28 ; IQR , 25-30 ; P = .61 ) .
RESULTS	The median IQCODE score was within the minor deficit range ( 33C group median , 79.5 ; IQR , 78.0-85 .9 ; vs 36C group median , 80.7 ; IQR , 78.0-86 .9 ; P = .04 ) .
RESULTS	A total of 18.8 % vs 17.5 % of survivors reported needing help with everyday activities ( P = .71 ) , and 66.5 % in the 33C group vs 61.8 % in the 36C group reported that they thought they had made a complete mental recovery ( P = .32 ) .
RESULTS	The mean ( SD ) mental component summary score was 49.1 ( 12.5 ) vs 49.0 ( 12.2 ) ( P = .79 ) , and the mean ( SD ) physical component summary score was 46.8 ( 13.8 ) and 47.5 ( 13.8 ) ( P = .45 ) , comparable to the population norm .
CONCLUSIONS	Quality of life was good and similar in patients with cardiac arrest receiving targeted temperature management at 33C or 36C .
CONCLUSIONS	Cognitive function was similar in both intervention groups , but many patients and observers reported impairment not detected previously by standard outcome scales .
BACKGROUND	ClinicalTrials.gov NCT01020916 .

###25361836
OBJECTIVE	Progression-free survival ( PFS ) is frequently used as an efficacy end point in oncology clinical trials .
OBJECTIVE	However , there is limited evidence to support a positive association between improvement in PFS and improvement in health-related quality of life ( HRQoL ) .
OBJECTIVE	The association between PFS and HRQoL was evaluated in two randomised trials .
METHODS	Data from two randomised controlled trials in patients with non-small cell lung cancer ( NSCLC ; LUX-Lung 1 and LUX-Lung 3 ) were used to investigate HRQoL in patients to determine whether tumour progression is accompanied by worsening HRQoL .
METHODS	HRQoL was assessed using the cancer-specific European Organization for Research and Treatment of Cancer ( EORTC ) core questionnaire QLQ-C30 , the EuroQol EQ-5D overall utility and EuroQol EQ visual analogue scale .
METHODS	In both studies , progression was evaluated by independent review using RECIST criteria ( primary end point ) and also by investigator assessment .
METHODS	The relationship between tumour progression and HRQoL was evaluated using analysis of covariance and a longitudinal model .
RESULTS	Compliance with HRQoL questionnaire completion was high .
RESULTS	In both studies , patients with progression consistently experienced numerically poorer HRQoL at the time of progression than patients without progression .
RESULTS	Differences in mean scores were statistically significant ( p < 0.05 ) between patients with and without progression at week 4 in all analyses in LUX-Lung 1 and at multiple time points in LUX-Lung 3 .
RESULTS	Results from the longitudinal analysis showed that progression ( by independent review and investigator assessment ) appears to have consistent negative impact on all three HRQoL measures ( all p < 0.0001 ) .
CONCLUSIONS	Tumour progression in patients with NSCLC was associated with statistically significant worsening in HRQoL .
CONCLUSIONS	These findings confirm the value of PFS as a patient-relevant end point .

###25141850
BACKGROUND	Falls are very common , especially in adults aged 65 years and older .
BACKGROUND	Within the current international European Commission 's Seventh Framework Program ( FP7 ) project ` iStoppFalls ' an Information and Communication Technology ( ICT ) based system has been developed to regularly assess a person 's risk of falling in their own home and to deliver an individual and tailored home-based exercise and education program for fall prevention .
BACKGROUND	The primary aims of iStoppFalls are to assess the feasibility and acceptability of the intervention program , and its effectiveness to improve balance , muscle strength and quality of life in older people .
METHODS	This international , multicenter study is designed as a single-blinded , two-group randomized controlled trial .
METHODS	A total of 160 community-dwelling older people aged 65 years and older will be recruited in Germany ( n = 60 ) , Spain ( n = 40 ) , and Australia ( n = 60 ) between November 2013 and May 2014 .
METHODS	Participants in the intervention group will conduct a 16-week exercise program using the iStoppFalls system through their television set at home .
METHODS	Participants are encouraged to exercise for a total duration of 180 minutes per week .
METHODS	The training program consists of a variety of balance and strength exercises in the form of video games using exergame technology .
METHODS	Educational material about a healthy lifestyle will be provided to each participant .
METHODS	Final reassessments will be conducted after 16 weeks .
METHODS	The assessments include physical and cognitive tests as well as questionnaires assessing health , fear of falling , quality of life and psychosocial determinants .
METHODS	Falls will be followed up for six months by monthly falls calendars .
CONCLUSIONS	We hypothesize that the regular use of this newly developed ICT-based system for fall prevention at home is feasible for older people .
CONCLUSIONS	By using the iStoppFalls sensor-based exercise program , older people are expected to improve in balance and strength outcomes .
CONCLUSIONS	In addition , the exercise training may have a positive impact on quality of life by reducing the risk of falls .
CONCLUSIONS	Taken together with expected cognitive improvements , the individual approach of the iStoppFalls program may provide an effective model for fall prevention in older people who prefer to exercise at home .
BACKGROUND	Australian New Zealand Clinical Trials Registry Trial ID : ACTRN12614000096651.International Standard Randomised Controlled Trial Number : ISRCTN15932647 .

###25109699
BACKGROUND	Polymorphisms of the HLA-DP gene are associated with the natural clearance of the hepatitis B virus in Asian patients .
OBJECTIVE	To investigate the association of HLA-DP polymorphisms with response to peginterferon ( PEG-IFN ) in Caucasian chronic hepatitis B ( CHB ) patients .
METHODS	We studied 262 Caucasian chronic hepatitis B patients infected with HBV genotype A or D , treated with PEG-IFN for 1 year in two randomised controlled trials ( HBV 99-01 and PARC study ) .
METHODS	Response was defined as an HBV DNA < 2000 IU/mL at 6 months post-treatment .
METHODS	Variations at HLA-DPA1 and HLA-DPB1 were genotyped .
RESULTS	Of the 262 patients , 58 % was HBeAg-positive and HBV genotype A and D was observed in 32 % and 68 % , respectively .
RESULTS	At 6 months post-treatment , 57 ( 22 % ) patients had achieved an HBV DNA < 2000 IU/mL .
RESULTS	HLA-DPB1 was independently associated with virological response [ adjusted odds ratio ( OR ) 1.8 , 95 % confidence interval ( CI ) :1.1 -3.0 , P = 0.025 ] , and with an undetectable HBV DNA ( adjusted OR 2.4 95 % CI : 1.2-4 .7 , P = 0.015 ) when adjusted for HBeAg status and other known response modifiers .
RESULTS	In HBeAg-positive patients , combined HBeAg seroconversion with HBV DNA < 2000 IU/mL was increasingly observed with each addition of an HLA-DPB1 G-allele ( adjusted OR 2.7 , 95 % CI : 1.2-5 .9 , P = 0.012 ) .
RESULTS	Furthermore , HLA-DPA1 and HLA-DPB1 haplotype block GG showed comparable results for virological and combined response .
CONCLUSIONS	In this large cohort of Caucasian chronic hepatitis B patients infected with HBV genotypes A or D , polymorphisms of HLA-DP are independently associated with both virological and serological response to PEG-IFN therapy at 6 months post-treatment .

###24726046
BACKGROUND	It is well documented that childhood abuse , neglect and household dysfunction are disproportionately present in the backgrounds of homeless adults , and that these experiences adversely impact child development and a wide range of adult outcomes .
BACKGROUND	However , few studies have examined the cumulative impact of adverse childhood experiences on homeless adults with mental illness .
BACKGROUND	This study examines adverse events in childhood as predictors of duration of homelessness , psychiatric and substance use disorders , and physical health in a sample of homeless adults with mental illness .
METHODS	This study was conducted using baseline data from a randomized controlled trial in Vancouver , British Columbia for participants who completed the Adverse Childhood Experiences ( ACE ) scale at 18 months follow-up ( n = 364 ) .
METHODS	Primary outcomes included current mental disorders ; substance use including type , frequency and severity ; physical health ; duration of homelessness ; and vocational functioning .
RESULTS	In multivariable regression models , ACE total score independently predicted a range of mental health , physical health , and substance use problems , and marginally predicted duration of homelessness .
CONCLUSIONS	Adverse childhood experiences are overrepresented among homeless adults with complex comorbidities and chronic homelessness .
CONCLUSIONS	Our findings are consistent with a growing body of literature indicating that childhood traumas are potent risk factors for a number of adult health and psychiatric problems , particularly substance use problems .
CONCLUSIONS	Results are discussed in the context of cumulative adversity and self-trauma theory .
BACKGROUND	This trial has been registered with the International Standard Randomized Control Trial Number Register and assigned ISRCTN42520374 .

###25344737
BACKGROUND	Sensory isolation in a flotation tank is a method known for inducing deep relaxation and subsequent positive health effects for patients suffering from e.g. stress or muscle tensions pains .
BACKGROUND	Very few studies have investigated this method as a preventive health-care intervention .
BACKGROUND	The purpose of this study was to evaluate the effects in healthy participants after receiving a series of flotation tank treatment .
METHODS	Sixty-five participants ( 14 men and 51 women ) who were all part of a cooperative-health project initiated by their individual companies , were randomized to either a wait-list control group or a flotation tank treatment group where they participated in a seven weeks flotation program with a total of twelve flotation sessions .
METHODS	Questionnaires measuring psychological and physiological variables such as stress and energy , depression and anxiety , optimism , pain , stress , sleep quality , mindfulness , and degree of altered states of consciousness were used .
METHODS	Data were analysed by two-way mixed MANOVA and repeated measures ANOVA .
RESULTS	Stress , depression , anxiety , and worst pain were significantly decreased whereas optimism and sleep quality significantly increased for the flotation-REST group .
RESULTS	No significant results for the control group were seen .
RESULTS	There was also a significant correlation between mindfulness in daily life and degree of altered states of consciousness during the relaxation in the flotation tank .
CONCLUSIONS	It was concluded that flotation-REST has beneficial effects on relatively healthy participants .
BACKGROUND	Australian New Zealand Clinical Trials Registry : ACTRN12613000483752 .

###24361112
BACKGROUND	Levodopa is the most effective therapy for Parkinson 's disease , but chronic treatment is associated with the development of potentially disabling motor complications .
BACKGROUND	Experimental studies suggest that motor complications are due to non-physiological , intermittent administration of the drug , and can be reduced with continuous delivery .
BACKGROUND	We aimed to assess efficacy and safety of levodopa-carbidopa intestinal gel delivered continuously through an intrajejunal percutaneous tube .
METHODS	In our 12-week , randomised , double-blind , double-dummy , double-titration trial , we enrolled adults ( aged 30 years ) with advanced Parkinson 's disease and motor complications at 26 centres in Germany , New Zealand , and the USA .
METHODS	Eligible participants had jejunal placement of a percutaneous gastrojejunostomy tube , and were then randomly allocated ( 1:1 ) to treatment with immediate-release oral levodopa-carbidopa plus placebo intestinal gel infusion or levodopa-carbidopa intestinal gel infusion plus oral placebo .
METHODS	Randomisation was stratified by site , with a mixed block size of 2 or 4 .
METHODS	The primary endpoint was change from baseline to final visit in motor off-time .
METHODS	We assessed change in motor on-time without troublesome dyskinesia as a prespecified key secondary outcome .
METHODS	We assessed efficacy in a full-analysis set of participants with data for baseline and at least one post-baseline assessment , and imputed missing data with the last observation carried forward approach .
METHODS	We assessed safety in randomly allocated patients who underwent the percutaneous gastrojejunostomy procedure .
METHODS	This study is registered with ClinicalTrials.gov , numbers NCT00660387 and NCT0357994 .
RESULTS	From baseline to 12 weeks in the full-analysis set , mean off-time decreased by 4.04 h ( SE 0.65 ) for 35 patients allocated to the levodopa-carbidopa intestinal gel group compared with a decrease of 2.14 h ( 0.66 ) for 31 patients allocated to immediate-release oral levodopa-carbidopa ( difference -1.91 h [ 95 % CI -3.05 to -0.76 ] ; p = 0.0015 ) .
RESULTS	Mean on-time without troublesome dyskinesia increased by 4.11 h ( SE 0.75 ) in the intestinal gel group and 2.24 h ( 0.76 ) in the immediate-release oral group ( difference 1.86 [ 95 % CI 0.56 to 3.17 ] ; p = 0.0059 ) .
RESULTS	In the safety analyses 35 ( 95 % ) of 37 patients allocated to the levodopa-carbidopa intestinal gel group had adverse events ( five [ 14 % ] serious ) , as did 34 ( 100 % ) of 34 patients allocated to the immediate-release oral levodopa-carbidopa group ( seven [ 21 % ] serious ) , mainly associated with the percutaneous gastrojejunostomy tube .
CONCLUSIONS	Continuous delivery of levodopa-carbidopa with an intestinal gel offers a promising option for control of advanced Parkinson 's disease with motor complications .
CONCLUSIONS	Benefits noted with intestinal gel delivery were of a greater magnitude than were those obtained with medical therapies to date , and our study is , to our knowledge , the first demonstration of the benefit of continuous levodopa delivery in a double-blind controlled study .
BACKGROUND	AbbVie .

###26125415
BACKGROUND	Mobile health services may improve chronic illness care , but interventions rarely support informal caregivers ' efforts .
OBJECTIVE	To determine whether automated feedback to caregivers of chronic heart failure patients impacts caregiving burden and assistance with self-management .
METHODS	Randomized comparative effectiveness trial .
METHODS	A total of 369 heart failure patients were recruited from a Veterans Health Administration health care system .
METHODS	All patients participated with a `` CarePartner '' or informal caregiver outside their household .
METHODS	Patients randomized to `` standard mHealth '' received weekly automated self-care support calls for 12 months with notifications about problems sent to clinicians .
METHODS	`` mobile health + CarePartner '' ( mHealth + CP ) patients received identical services , plus email summaries and suggestions for self-care assistance automatically sent to their CarePartners .
METHODS	At baseline , 6 , and 12 months , CarePartners completed assessments of caregiving strain , depressive symptoms , and participation in self-care support .
RESULTS	mHealth + CP CarePartners reported less caregiving strain than controls at both 6 and 12 months ( both P0 .03 ) .
RESULTS	That effect as well as improvements in depressive symptoms were seen primarily among CarePartners reporting greater burden at baseline ( P0 .03 for interactions between arm and baseline strain/depression at both endpoints ) .
RESULTS	Although most mHealth + CP CarePartners increased the amount of time spent in self-care support , those with the highest time commitment at baseline reported decreases at both follow-ups ( all P < 0.05 ) .
RESULTS	mHealth + CP CarePartners reported more frequently attending patients ' medical visits at 6 months ( P = 0.049 ) and greater involvement in medication adherence at both endpoints ( both P0 .032 ) .
CONCLUSIONS	When CarePartners experienced significant caregiving strain and depression , systematic feedback about their patient-partner decreased those symptoms .
CONCLUSIONS	Feedback also increased most CarePartners ' engagement in self-care .

###24667813
OBJECTIVE	The VACS Index is highly predictive of all-cause mortality among HIV infected individuals within the first few years of combination antiretroviral therapy ( cART ) .
OBJECTIVE	However , its accuracy among highly treatment experienced individuals and its responsiveness to treatment interventions have yet to be evaluated .
OBJECTIVE	We compared the accuracy and responsiveness of the VACS Index with a Restricted Index of age and traditional HIV biomarkers among patients enrolled in the OPTIMA study .
METHODS	Using data from 324/339 ( 96 % ) patients in OPTIMA , we evaluated associations between indices and mortality using Kaplan-Meier estimates , proportional hazards models , Harrel 's C-statistic and net reclassification improvement ( NRI ) .
METHODS	We also determined the association between study interventions and risk scores over time , and change in score and mortality .
RESULTS	Both the Restricted Index ( c = 0.70 ) and VACS Index ( c = 0.74 ) predicted mortality from baseline , but discrimination was improved with the VACS Index ( NRI = 23 % ) .
RESULTS	Change in score from baseline to 48 weeks was more strongly associated with survival for the VACS Index than the Restricted Index with respective hazard ratios of 0.26 ( 95 % CI 0.14-0 .49 ) and 0.39 ( 95 % CI 0.22-0 .70 ) among the 25 % most improved scores , and 2.08 ( 95 % CI 1.27-3 .38 ) and 1.51 ( 95 % CI 0.90-2 .53 ) for the 25 % least improved scores .
CONCLUSIONS	The VACS Index predicts all-cause mortality more accurately among multi-drug resistant , treatment experienced individuals and is more responsive to changes in risk associated with treatment intervention than an index restricted to age and HIV biomarkers .
CONCLUSIONS	The VACS Index holds promise as an intermediate outcome for intervention research .

###25322972
OBJECTIVE	The purpose of this study was to compare the impact of music therapy ( MT ) versus music medicine ( MM ) interventions on psychological outcomes and pain in cancer patients and to enhance understanding of patients ' experiences of these two types of music interventions .
METHODS	This study employed a mixed methods intervention design in which qualitative data were embedded within a randomized cross-over trial .
METHODS	Thirty-one adult cancer patients participated in two sessions that involved interactive music making with a music therapist ( MT ) and two sessions in which they listened to pre-recorded music without the presence of a therapist ( MM ) .
METHODS	Before and after each session , participants reported on their mood , anxiety , relaxation , and pain by means of visual analogue and numeric rating scales .
METHODS	Thirty participants completed an exit interview .
RESULTS	The quantitative data suggest that both interventions were equally effective in enhancing target outcomes .
RESULTS	However , 77.4 % of participants expressed a preference for MT sessions .
RESULTS	The qualitative data indicate that music improves symptom management , embodies hope for survival , and helps connect to a pre-illness self , but may also access memories of loss and trauma .
RESULTS	MT sessions helped participants tap into inner resources such as playfulness and creativity .
RESULTS	Interactive music making also allowed for emotional expression .
RESULTS	Some participants preferred the familiarity and predictability of listening to pre-recorded music .
CONCLUSIONS	The findings of this study advocate for the use of music in cancer care .
CONCLUSIONS	Treatment benefits may depend on patient characteristics such as outlook on life and readiness to explore emotions related to the cancer experience .

###25363153
BACKGROUND	Home and school environments conducive for unhealthy eating and physical inactivity are precursors of obesity .
BACKGROUND	The aim of this study is evaluation of the effectiveness of a multi-component school-based weight management programme for overweight and obese primary school children via a home-school joint venture .
METHODS	This study made use of variety of behavioural modification strategies integrating into the Health Promoting School approach to promote healthy lifestyles .
METHODS	The participants were overweight and obese students aged between 8 and 12 from six participating schools .
METHODS	The interventions involved students attending ten 75 minutes after-school sessions and one 3-hour week-end session of practical interactive and fun activities on healthy eating and exercise , and meal plan together with parents and printed tailor-made management advices .
METHODS	Parents received an introductory seminar with 2 sets of specially designed exercise for their overweight children .
METHODS	The tools to measure bodyweight and fat percentage and standing height were bio-impedance body fat scale and a portable stadiometer .
METHODS	Self-administered questionnaire was used to measure knowledge , attitudes and behaviours .
METHODS	McNemar test was utilized to compare the proportions of behaviour changes within the same group to assess for the trends of changes .
METHODS	BMI z-score and body fat percentage of intervention participants at baseline , 4 month and 8 month were compared pair-wisely using tests of within subject contrasts in repeated measures ANOVA to assess for programme sustainability .
RESULTS	Those students in the intervention group reduced their BMI z-score ( -0.21 , 95 % CI -0.34 to -0.07 , P = 0.003 ) and body fat ( -2.67 % , 95 % CI -5.12 to -0.22 , P = 0.033 ) compared to wait list control group with statistical significant , and the intervention group also had a significant reduction in BMI z-score ( -0.06 , 95 % CI -0.11 , -0.007 , P = 0.028 ) and body fat ( -1.71 % , 95 % CI , -3.44 to 0.02 , P = 0.052 ) after a 4 month maintenance period .
RESULTS	Improvement of dietary habits and positive attitudes towards exercise were observed among the intervention group .
CONCLUSIONS	School based weight management programme integrated into a Health Promoting School approach with improved school policies and environment in supporting individual skills of obese students and their parents appears to be a promising practice for sustaining weight control .
BACKGROUND	ISRCTN58795797 .

###25886354
BACKGROUND	Need for recovery and work ability are strongly associated with high employee turnover , well-being and sickness absence .
BACKGROUND	However , scientific knowledge on effective interventions to improve work ability and decrease need for recovery is scarce .
BACKGROUND	Thus , the present study aims to describe the background , design and protocol of a cluster randomized controlled trial evaluating the effectiveness of an intervention to reduce need for recovery and improve work ability among industrial workers .
METHODS	A two-year cluster randomized controlled design will be utilized , in which controls will also receive the intervention in year two .
METHODS	More than 400 workers from three companies in Denmark will be aimed to be cluster randomized into intervention and control groups with at least 200 workers ( at least 9 work teams ) in each group .
METHODS	An organizational resources audit and subsequent action planning workshop will be carried out to map the existing resources and act upon initiatives not functioning as intended .
METHODS	Workshops will be conducted to train leaders and health and safety representatives in supporting and facilitating the intervention activities .
METHODS	Group and individual level participatory visual mapping sessions will be carried out allowing team members to discuss current physical and psychosocial work demands and resources , and develop action plans to minimize strain and if possible , optimize the resources .
METHODS	At all levels , the intervention will be integrated into the existing organization of work schedules .
METHODS	An extensive process and effect evaluation on need for recovery and work ability will be carried out via questionnaires , observations , interviews and organizational data assessed at several time points throughout the intervention period .
CONCLUSIONS	This study primarily aims to develop , implement and evaluate an intervention based on the abovementioned features which may improve the work environment , available resources and health of industrial workers , and hence their need for recovery and work ability .

###25243574
BACKGROUND	In 2-year-old children with Down 's syndrome ( DS ) , early T4 treatment was found to result in slightly better motor development and growth .
OBJECTIVE	This study sought to determine long-term effects of early T4 treatment on development and growth in children with DS with either an elevated or normal neonatal TSH concentration .
METHODS	Patients received a single follow-up visit 8.7 years after a randomized placebo-controlled trial ( RCT ) comparing T4 and placebo treatment during the first 2 years of life .
METHODS	Dutch Academic Hospital .
METHODS	All children who completed the RCT ( N = 181 , of 196 randomly assigned children ) were invited for the follow-up study .
METHODS	A total of 123 participants enrolled , at a mean age of 10.7 years .
METHODS	T4 or placebo treatment from the neonatal period until 2 years .
METHODS	Primary : mental and motor development .
METHODS	Secondary : communication skills , fine-motor coordination , height , weight , and head circumference ( HC ) .
METHODS	Outcomes were compared between T4 - and placebo-treated children , and between treatment groups with either a normal ( < 5 mIU/L ) , or elevated ( 5 mIU/L ) TSH concentration at original trial entry .
RESULTS	Mental or motor development , communication skills , or fine-motor coordination did not differ between T4 - ( N = 64 ) and placebo-treated children ( N = 59 ) .
RESULTS	T4-treated children had a larger HC ( 50.4 vs 49.8 cm , P = .04 ) and tended to be taller ( 133.2 vs 131.1 cm , P = .06 ) .
RESULTS	These differences were somewhat greater in children with TSH 5 mIU/L ( HC : T4 , 50.5 vs placebo , 49.7 cm ; P = .01 ; height : T4 , 133.8 vs placebo , 130.8 cm ; P = .02 ) , but were not found in children with TSH < 5 mIU/L ( HC : T4 , 50.1 vs placebo , 50.0 cm ; P = .75 ; height : T4 , 132.1 vs placebo , 131.6 cm ; P = .22 ) .
CONCLUSIONS	Early T4 treatment of children with DS does not seem to benefit mental or motor development later in life .
CONCLUSIONS	However , the positive effect on growth is still measurable , especially in children with an elevated plasma TSH concentration in the neonatal period .

###24598949
OBJECTIVE	To compare pressure-support ventilation with spontaneous breathing through a T-tube for interrupting invasive mechanical ventilation in patients undergoing cardiac surgery with cardiopulmonary bypass .
METHODS	Adults of both genders were randomly allocated to 30 minutes of either pressure-support ventilation or spontaneous ventilation with `` T-tube '' before extubation .
METHODS	Manovacuometry , ventilometry and clinical evaluation were performed before the operation , immediately before and after extubation , 1h and 12h after extubation .
RESULTS	Twenty-eight patients were studied .
RESULTS	There were no deaths or pulmonary complications .
RESULTS	The mean aortic clamping time in the pressure support ventilation group was 62 35 minutes and 68 36 minutes in the T-tube group ( P = 0.651 ) .
RESULTS	The mean cardiopulmonary bypass duration in the pressure-support ventilation group was 89 44 minutes and 82 42 minutes in the T-tube group ( P = 0.75 ) .
RESULTS	The mean Tobin index in the pressure support ventilation group was 51 25 and 64.5 23 in the T-tube group ( P = 0.153 ) .
RESULTS	The duration of intensive care unit stay for the pressure support ventilation group was 2.1 0.36 days and 2.3 0.61 days in the T-tube group ( P = 0.581 ) .
RESULTS	The atelectasis score in the T-tube group was 0.6 0.8 and 0.5 0.6 ( P = 0.979 ) in the pressure support ventilation group .
RESULTS	The study groups did not differ significantly in manovacuometric and ventilometric parameters and hospital evolution .
CONCLUSIONS	The two trial methods evaluated for interruption of mechanical ventilation did not affect the postoperative course of patients who underwent cardiac operations with cardiopulmonary bypass .

###24894359
BACKGROUND	This study represents an effort to advance our understanding of the nature of school readiness among children with language impairment ( LI ) , a population of children acknowledged to be at risk of poor academic achievement .
BACKGROUND	The academic , social-emotional , and behavioural competencies with which children arrive at kindergarten affect the nature of their future educational experiences , and their overall academic achievement .
OBJECTIVE	To examine whether there are reliable profiles that characterize children with LI just prior to kindergarten entrance , and the extent to which profile membership is associated with characteristics of children 's homes and preschool experiences .
OBJECTIVE	Questions addressed were twofold : ( 1 ) To what extent are there reliable profiles of children with LI with respect to their school readiness ?
OBJECTIVE	( 2 ) To what extent is children 's profile membership associated with characteristics of their homes and preschool classrooms ?
METHODS	Participants were 136 children with LI from early childhood special education classrooms .
METHODS	We utilized latent class analysis ( LCA ) to classify individuals into profiles based on individual responses on school readiness measures .
METHODS	We then used multilevel hierarchical generalized linear models to examine the relations between profile membership and children 's home/classroom experiences .
RESULTS	LCA analyses revealed that a four-profile solution was the most appropriate fit for the data and that classroom experiences were predictive of these profiles , such that children in classrooms with more instructional/emotional support were more likely to be placed in profiles characterized by higher school readiness skills .
CONCLUSIONS	These results suggest that the school readiness profiles of young children with LI are associated with the quality of children 's classroom experiences , and that high-quality classroom experiences can be influential for ensuring that young children with LI arrive in kindergarten ready to learn .

###25018057
OBJECTIVE	Preclinical studies have shown that low-dose methylene blue increases mitochondrial cytochrome oxidase activity in the brain and improves memory retention after learning tasks , including fear extinction .
OBJECTIVE	The authors report on the first controlled experiment to examine the memory-enhancing effects of posttraining methylene blue administration on retention of fear extinction and contextual memory following fear extinction training .
METHODS	Adult participants displaying marked claustrophobic fear were randomly assigned to double-blind administration of 260 mg of methylene blue ( N = 23 ) or administration of placebo ( N = 19 ) immediately following six 5-minute extinction trials in an enclosed chamber .
METHODS	Retesting occurred 1 month later to assess fear renewal as indexed by peak fear during exposure to a nontraining chamber , with the prediction that the effects of methylene blue would vary as a function of fear reduction achieved during extinction training .
METHODS	Incidental contextual memory was assessed 1 and 30 days after training to assess the cognitive-enhancing effects of methylene blue independent of its effects on fear attenuation .
RESULTS	Consistent with predictions , participants displaying low end fear posttraining showed significantly less fear at the 1-month follow-up if they received methylene blue posttraining compared with placebo .
RESULTS	In contrast , participants displaying moderate to high levels of posttraining fear tended to fare worse at the follow-up if they received methylene blue posttraining .
RESULTS	Methylene blue 's enhancement of contextual memory was unrelated to initial or posttraining claustrophobic fear .
CONCLUSIONS	Methylene blue enhances memory and the retention of fear extinction when administered after a successful exposure session but may have a deleterious effect on extinction when administered after an unsuccessful exposure session .

###25358679
BACKGROUND	Many maternity providers recommend that women with diabetes in pregnancy express and store breast milk in late pregnancy so breast milk is available after birth , given ( 1 ) infants of these women are at increased risk of hypoglycaemia in the first 24 h of life ; and ( 2 ) the delay in lactogenesis II compared with women without diabetes that increases their infant 's risk of receiving infant formula .
BACKGROUND	The Diabetes and Antenatal Milk Expressing ( DAME ) trial will establish whether advising women with diabetes in pregnancy ( pre-existing or gestational ) to express breast milk from 36 weeks gestation increases the proportion of infants who require admission to special or neonatal intensive care units ( SCN/NICU ) compared with infants of women receiving standard care .
BACKGROUND	Secondary outcomes include birth gestation , breastfeeding outcomes and economic impact .
METHODS	Women will be recruited from 34 weeks gestation to a multicentre , two arm , unblinded randomised controlled trial .
METHODS	The intervention starts at 36 weeks .
METHODS	Randomisation will be stratified by site , parity and diabetes type .
METHODS	Women allocated to the intervention will be taught expressing and encouraged to hand express twice daily for 10 min and keep an expressing diary .
METHODS	The sample size of 658 ( 329 per group ) will detect a 10 % difference in proportion of babies admitted to SCN/NICU ( 85 % power , 0.05 ) .
METHODS	Data are collected at recruitment ( structured questionnaire ) , after birth ( abstracted from medical record blinded to group ) , and 2 and 12 weeks postpartum ( telephone interview ) .
METHODS	the intervention group will be compared with the standard care group by intention to treat analysis , and the primary outcome compared using ( 2 ) and ORs .
BACKGROUND	Research ethics approval will be obtained from participating sites .
BACKGROUND	Results will be published in peer-reviewed journals and presented to clinicians , policymakers and study participants .
BACKGROUND	Australian Controlled Trials Register ACTRN12611000217909 .

###24474305
BACKGROUND	Smoking prevalence is 49 % among Medicaid enrollees in Ohio .
BACKGROUND	The objective of this pilot project was to test a comprehensive tobacco dependence treatment program targeting rural Medicaid-enrolled smokers for both physician-level and smoker-level outcomes .
METHODS	Using a group-randomized trial design , intervention group physicians ( n = 4 ) were exposed to systems-level changes in their clinics , and smokers in these clinics were offered 12 weeks of telephone cessation counseling .
METHODS	Control group physicians ( n = 4 ) were given the clinician 's version of the U.S. Public Health Serivce ( USPHS ) Clinical Practice Guideline , and smokers in these clinics were given information about the Ohio Tobacco Quitline .
METHODS	Physician-level and smoker-level outcomes were assessed at 1 week and 3 months , respectively .
METHODS	Costs per quit were estimated .
RESULTS	A total of 214 Medicaid smokers were enrolled .
RESULTS	At 1 week , there were no reported differences in rates of being asked about tobacco use ( 68 % intervention , 58 % control ) or advised to quit ( 69 % intervention , 63 % control ) .
RESULTS	However , 30 % of intervention and 56 % of control smokers reported receiving a prescription for pharmacotherapy ( p < .01 ) .
RESULTS	At 3 months , there were no differences in quit attempts ( 58 % intervention , 64 % control ) , use of pharmacotherapy ( 34 % intervention , 46 % control ) , or abstinence ( 24 % intervention , 16 % control for self-reported abstinence ; 11 % intervention , 3.5 % control for cotinine-confirmed abstinence ) .
RESULTS	The intervention group proved more cost-effective at achieving confirmed quits ( $ 6,800 vs. $ 9,700 ) .
CONCLUSIONS	We found few differences in outcomes between physicians exposed to a brief intervention and physicians who were intensively trained .
CONCLUSIONS	Future studies should examine how tobacco dependence treatment can be further expanded in Medicaid programs .

###25582785
OBJECTIVE	To compare the efficacy of lidocaine , bupivacaine , and a mixture of both in patients undergoing peribulbar anesthesia for vitreoretinal surgery .
METHODS	Cross-sectional study .
METHODS	Ninety patients .
METHODS	Patients who underwent vitreoretinal surgery were randomized into 3 groups based on the peribulbar injection they received : lidocaine , bupivacaine , or a combination of lidocaine and bupivacaine .
METHODS	Time of onset of analgesia , akinesia , and intraoperative pain , if any , was noted .
METHODS	The efficacy of the block was graded from 0 to 5 depending on the adequacy of anesthesia and akinesia and the need for local supplementation .
RESULTS	Mean times of onset ( standard deviation ) of sensory blockade for the lidocaine , bupivacaine , and combination groups were 2.140.18 , 2.190.13 , and 2.170.11 minutes , respectively ( P = 0.103 ) .
RESULTS	Mean times of onset ( standard deviation ) of motor blockade for the lidocaine , bupivacaine , and combination groups were 3.041.81 , 4.042.68 , and 3.382.48 minutes , respectively ( P = 0.255 ) .
RESULTS	Mean time of onset of intraoperative pain for the bupivacaine group , 149.3346.33 minutes , was prolonged significantly compared with that of the combination group , 115.8334.49 minutes , and that of the lidocaine group , 94.1749.86 minutes ( P < 0.001 ) .
RESULTS	Adequate anesthesia and akinesia ( grade 5 ) were achieved in 56.7 % of the patients in the bupivacaine group compared with 23.3 % in the lidocaine group and 30 % in the combination group ( P = 0.049 ) .
CONCLUSIONS	In peribulbar anesthesia , 0.5 % bupivacaine solution provides better quality of anesthesia than does combination 2 % lidocaine and 0.5 % bupivacaine in patients undergoing vitreoretinal surgery .

###26241598
OBJECTIVE	Intimate partner violence ( IPV ) and heavy drinking are co-occurring public health problems , but integrated brief interventions for these conditions have not been tested .
OBJECTIVE	To determine whether a brief motivational intervention provided at the time of an emergency department ( ED ) visit reduces IPV and heavy drinking .
METHODS	A randomized clinical trial conducted at 2 US academic urban EDs between January 2011 and December 2014 to assess the effectiveness of a motivational intervention for IPV-involved female ED patients ( ages : 18-64 years ; N = 600 ) who exceeded sex-specific safe drinking limits .
METHODS	All received social service referrals ; 2:2:1 to brief intervention ( n = 242 ) , assessed control ( n = 237 ) , or no-contact control ( n = 121 ) .
METHODS	A 20 - to 30-minute manual-guided motivational intervention ( recorded and monitored for fidelity ) delivered by master 's - level therapists with a follow-up telephone booster .
METHODS	The assessed control group received the same number of assessments as the brief intervention group ; the no-contact control group was assessed only once at 3 months .
METHODS	Incidents of heavy drinking and experiencing IPV measured over prespecified , 12 weekly assessments using an interactive voice response system .
RESULTS	Of 600 participants , 80 % were black women with a mean age of 32 years .
RESULTS	Retention was 89 % for 2 or more interactive voice response system calls .
RESULTS	Seventy-eight percent of women completed the 3-month interview , 79 % at 6 months , and 71 % at 12 months .
RESULTS	During the 12-week period following the brief motivational intervention , there were no significant differences between the intervention group and the assessed control group on weekly assessments for experiencing IPV ( odds ratio [ OR ] , 1.02 ; 95 % CI , 0.98-1 .06 ) or heavy drinking ( OR , 0.99 ; 95 % CI , 0.96-1 .03 ) .
RESULTS	From baseline to 12 weeks , the number of women with any IPV in the past week decreased from 57 % ( 134 of 237 ) in the intervention group to 43 % ( 83 of 194 ) and from 63 % ( 145 of 231 ) in the assessed control group to 41 % ( 77 of 187 ) ( absolute difference of 8 % ) .
RESULTS	From baseline to 12 weeks , the number of women with past week heavy drinking decreased from 51 % ( 120 of 236 ) in the intervention group to 43 % ( 83 of 194 ) and from 46 % ( 107 of 231 ) in the assessed control group to 41 % ( 77 of 187 ) ( absolute difference of 3 % ) .
RESULTS	At 12 months , 43 % ( 71 of 165 ) of the intervention group and 47 % ( 78 of 165 ) of the assessed control group reported no IPV during the previous 3 months and 19 % ( 29 of 152 ) of the intervention group and 24 % ( 37 of 153 ) of the control group had reduced their alcohol consumption to sex-specific National Institute on Alcohol Abuse and Alcoholism safe drinking levels .
CONCLUSIONS	For women experiencing IPV and heavy drinking , the use of a brief motivational intervention in the ED compared with assessed and no-contact controls did not significantly reduce the days of heavy drinking or incidents of IPV .
CONCLUSIONS	These findings do not support a brief motivational intervention in this setting .
BACKGROUND	clinicaltrials.gov Identifer : NCT01207258 .

###25710925
BACKGROUND	Whether a coronary artery calcium ( CAC ) scan provides added value to coronary computed tomographic angiography ( CCTA ) in emergency department patients with acute chest pain remains unsettled .
BACKGROUND	We sought to determine the value of CAC scan in patients with acute chest pain undergoing CCTA .
RESULTS	In the multicenter Rule Out Myocardial Infarction using Computer-Assisted Tomography ( ROMICAT ) II trial , we enrolled low-intermediate risk emergency department patients with symptoms suggesting acute coronary syndrome ( ACS ) .
RESULTS	In this prespecified subanalysis of 473 patients ( 548 years , 53 % men ) who underwent both CAC scanning and CCTA , the ACS rate was 8 % .
RESULTS	Overall , 53 % of patients had CAC = 0 of whom 2 ( 0.8 % ) developed ACS , whereas 7 % had CAC > 400 with 49 % whom developed ACS .
RESULTS	C-statistic of CAC > 0 was 0.76 , whereas that using the optimal cut point of CAC22 was 0.81 .
RESULTS	Continuous CAC score had lower discriminatory capacity than CCTA ( c-statistic , 0.86 versus 0.92 ; P = 0.03 ) .
RESULTS	Compared with CCTA alone , there was no benefit combining CAC score with CCTA ( c-statistic , 0.93 ; P = 0.88 ) or with selective CCTA strategies after initial CAC > 0 or optimal cut point CAC22 ( P0 .09 ) .
RESULTS	Mean radiation dose from CAC acquisition was 1.40.7 mSv .
RESULTS	Higher CAC scores resulted in more nondiagnostic CCTA studies although the majority remained interpretable .
CONCLUSIONS	In emergency department patients with acute chest pain , CAC score does not provide incremental value beyond CCTA for ACS diagnosis .
CONCLUSIONS	CAC = 0 does not exclude ACS , nor a high CAC score preclude interpretation of CCTA in most patients .
CONCLUSIONS	Thus , CAC results should not influence the decision to proceed with CCTA , and the decision to perform a CAC scan should be balanced with the additional radiation exposure required .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01084239 .

###24300437
BACKGROUND	The duration and exclusivity of breastfeeding in infancy have been inversely associated with future cardiometabolic risk .
BACKGROUND	We investigated the effects of an experimental intervention to promote increased duration of exclusive breastfeeding on cardiometabolic risk factors in childhood .
RESULTS	We followed-up children in the Promotion of Breastfeeding Intervention Trial , a cluster-randomized trial of a breastfeeding promotion intervention based on the World Health Organization/United Nations Children 's Fund Baby-Friendly Hospital Initiative .
RESULTS	In 1996 to 1997 , 17 046 breastfeeding mother-infant pairs were enrolled from 31 Belarusian maternity hospitals and affiliated polyclinics ( 16 intervention versus 15 control sites ) ; 13 879 ( 81.4 % ) children were followed up at 11.5 years , with 13 616 ( 79.9 % ) who had fasted and did not have diabetes mellitus .
RESULTS	The outcomes were blood pressure ; fasting insulin , adiponectin , glucose , and apolipoprotein A1 ; and the presence of metabolic syndrome .
RESULTS	Analysis was by intention to treat , accounting for clustering within hospitals/clinics .
RESULTS	The intervention substantially increased breastfeeding duration and exclusivity in comparison with the control arm ( 43 % versus 6 % and 7.9 % versus 0.6 % exclusively breastfed at 3 and 6 months , respectively ) .
RESULTS	Cluster-adjusted mean differences at 11.5 years between experimental versus control groups were as follows : 1.0 mm Hg ( 95 % confidence interval , -1.1 to 3.1 ) for systolic and 0.8 mm Hg ( -0.6 to 2.3 ) for diastolic blood pressure ; -0.1 mmol/L ( -0.2 to 0.1 ) for glucose ; 8 % ( -3 % to 34 % ) for insulin ; -0.3 g/mL ( -1.5 to 0.9 ) for adiponectin ; and 0.0 g/L ( -0.1 to 0.1 ) for apolipoprotein A1 .
RESULTS	The cluster-adjusted odds ratio for metabolic syndrome , comparing experimental versus control groups , was 1.21 ( 0.85 to 1.72 ) .
CONCLUSIONS	An intervention to improve breastfeeding duration and exclusivity among healthy term infants did not influence cardiometabolic risk factors in childhood .
BACKGROUND	Current Controlled Trials : ISRCTN37687716 ( http://www.controlled-trials.com/ISRCTN37687716 ) .
BACKGROUND	URL : http://clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01561612 .

###25346026
BACKGROUND	Agitation is prevalent among people with dementia ( PWD ) in nursing homes .
BACKGROUND	It frustrates both the PWD and their caregivers .
BACKGROUND	Acupressure is a non-pharmacological intervention whose effectiveness is supported by preliminary studies .
BACKGROUND	However , there is still a dearth of evidence to explain its effect for clinical use and further research .
BACKGROUND	The present study is being conducted primarily to investigate the effects of acupressure as compared with sham-acupressure and usual care .
METHODS	This study is a multicenter , assessor/participant/statistician-blinded , parallel group , randomized controlled trial taking place in Hong Kong nursing homes .
METHODS	We have been recruiting PWD over 65 years of age in nursing homes , who are experiencing agitation ; 99 participants will be recruited in order to demonstrate a significant effect difference ( that is , f = 0.27 ) with a power of 0.8 and a significance level of 0.05 among the three groups .
METHODS	Participants are assigned by permuted block randomization into three groups in a 1:1:1 ratio .
METHODS	In the acupressure group , participants receive acupressure at the Fengchi ( GB20 ) , Baihui ( GV20 ) , Shenmen ( HT7 ) , Niguan ( PC6 ) and Yingtang ( EX-HN3 ) acupoints .
METHODS	In the sham-acupressure group , participants receive pressure on five non-acupoints .
METHODS	In the usual-care group , participants receive no intervention apart from the care provided by the nursing homes .
METHODS	Participants assigned to the sham-acupressure and usual-care groups receive free acupressure , like those in the acupressure group , after completion of the study .
METHODS	The whole study lasts for 30 weeks , and its primary outcome measure is agitation .
METHODS	The general estimated equation model will be used to compare the effects among groups and time points .
METHODS	The trial is currently recruiting participants .
CONCLUSIONS	This trial will provide a higher quality of evidence than previous studies on the use of acupressure for agitation in PWD .
CONCLUSIONS	It will also provide newer evidence on acupressure in the population of PWD with agitation for clinical application and further research , including the effect on moderating stress , the delayed effect , the added effect on the placebo , and the effect on moderating the participant 's use of psychotropic drugs .
BACKGROUND	Centre for Clinical Trials Clinical Trials Registry : CUHK_CCT00347 ( Registration date : 13 December 2012 ) .

###24373344
OBJECTIVE	To evaluate the effects of repeated intravitreal injections of bevacizumab ( IVB ) versus triamcinolone acetonide ( IVT ) in the treatment of acute central retinal vein occlusion ( CRVO ) .
METHODS	In this randomized clinical trial , 86 eyes with recent onset ( < 12 weeks ) CRVO were assigned to two groups : IVB group ( 43 eyes ) that received three monthly injections of 1.25 mg of IVB , and IVT group ( 43 eyes ) that received two injections of 2 mg IVT 2 months apart .
METHODS	Outcomes were best-corrected visual acuity ( BCVA ) , central macular thickness ( CMT ) , and intraocular pressure ( IOP ) changes .
RESULTS	Mean BCVA improved significantly at 6 months in both groups ; from 0.87 0.49 to 0.41 0.35 logMAR in IVB group , and from 0.81 0.45 to 0.62 0.48 logMAR in IVT group ( p < 0.001 ) .
RESULTS	However , between-group differences reach a significant level at months 4 ( p = 0.003 ) and 6 ( p < 0.001 ) in favour of the IVB group .
RESULTS	In terms of CMT reduction , the difference between the groups was statistically significant ( p = 0.002 ) at month 6 .
RESULTS	Significant differences were noted more in the ischaemic cases in favour of the IVB group .
RESULTS	Mean IOP rise was significantly higher in the IVT group at all visits .
CONCLUSIONS	Both 3-times monthly IVB injections and 2-times IVT injections could be effective in cases with recent onset CRVO up to 6 months .
CONCLUSIONS	However , considering the better outcomes after IVB injections and the potential complications of IVT injections , we would recommend prescheduled repeated IVB injections for such cases .
CONCLUSIONS	The observed favourable responses were more pronounced in the ischaemic types ; nevertheless , this should be confirmed in larger studies .

###24449031
OBJECTIVE	This randomized controlled study compared acceptance and commitment therapy ( ACT ) , cognitive-behavioral therapy ( CBT ) , and a control group .
METHODS	The participants were 50 incarcerated women diagnosed with current substance use disorder .
METHODS	Two psychologists carried out pre - and posttreatment assessment and a 6-month follow-up assessment using the following instruments : Anxiety Sensitivity Index , Addiction Severity Index-6 , Mini International Neuropsychiatric Interview , and Acceptance and Action Questionnaire .
RESULTS	The study shows that the women who received treatment benefited differentially from the interventions .
RESULTS	At posttreatment , CBT was more effective than ACT in reducing anxiety sensitivity ; however , at follow-up , ACT was more effective than CBT in reducing drug use ( 43.8 vs. 26.7 % , respectively ) and improving mental health ( 26.4 % vs. 19.4 % , respectively ) .
CONCLUSIONS	ACT may be an alternative to CBT for treatment of drug abuse and associated mental disorders .
CONCLUSIONS	In fact , at long-term , ACT may be more appropriate than CBT for incarcerated women who present serious problems .

###25043834
OBJECTIVE	Gatekeeper training ( GKT ) programs are an increasingly popular approach to addressing access to mental health care in adolescent and young adult populations .
OBJECTIVE	This study evaluates the effectiveness of a widely used GKT program , Mental Health First Aid , in college student populations .
METHODS	A randomized control trial was conducted on 32 colleges and universities between 2009 and 2011 .
METHODS	Campus residence halls were assigned to the intervention ( Mental Health First Aid plus pre-existing trainings ) or control condition ( pre-existing trainings only ) using matched pair randomization .
METHODS	The trainings were delivered to resident advisors ( RAs ) .
METHODS	Outcome measures include service utilization , knowledge and attitudes about services , self-efficacy , intervention behaviors , and mental health symptoms .
METHODS	Data come from two sources : ( 1 ) surveys completed by the students ( resident advisors and residents ; N = 2,543 ) , 2-3months pre - and post-intervention ; and ( 2 ) utilization records from campus mental health centers , aggregated by residence .
RESULTS	The training increases trainees ' self-perceived knowledge ( regression-adjusted effect size [ ES ] = .38 , p < .001 ) , self-perceived ability to identify students in distress ( ES = .19 , p = .01 ) , and confidence to help ( ES = .17 , p = .04 ) .
RESULTS	There are no apparent effects , however , on utilization of mental health care in the student communities in which the trainees live .
CONCLUSIONS	Although GKT programs are widely used to increase access to mental health care , these programs may require modifications to achieve their objectives .

###24594248
OBJECTIVE	To investigate whether nursing staff can successfully use the I-gel and the intubating laryngeal mask Fastrach ( ILMA ) during cardiopulmonary resuscitation .
BACKGROUND	Although tracheal intubation is considered to be the optimal method for securing the airway during cardiopulmonary resuscitation , laryngoscopy requires a high level of skill .
METHODS	Forty five nurses inserted the I-gel and the ILMA in a manikin , with continuous and without chest compressions .
RESULTS	Mean intubation times for the ILMA and I-gel without chest compressions were 20.603.27 and 18.403.26 s , respectively ( p < 0.0005 ) .
RESULTS	ILMA proved more successful than the I-gel regardless of compressions .
RESULTS	Continuation of compressions caused a prolongation in intubation times for both the I-gel ( p < 0.0005 ) and the ILMA ( p < 0.0005 ) .
CONCLUSIONS	In this mannequin study , nursing staff can successfully intubate using the I-gel and the ILMA as conduits with comparable success rates , regardless of whether chest compressions are interrupted or not .

###24998109
OBJECTIVE	Postoperative bleeding has a great clinical importance and can contribute to increased mortality and morbidity in patients undergoing coronary artery bypass graft surgery .
OBJECTIVE	In this prospective , randomized , double-blind study , we evaluated the effect of prophylactic administration of fibrinogen concentrate on post-coronary artery bypass graft surgery bleeding .
METHODS	A total of 60 patients undergoing coronary artery bypass surgery were randomly divided into two groups .
METHODS	Patients in the fibrinogen group received 1g of fibrinogen concentrate 30 min prior to the operation , while patients in the control group received placebo .
METHODS	Post-operative bleeding volumes , prothrombin time , partial thromboplastin time , INR , hemoglobin and transfused blood products in both groups were recorded .
METHODS	A strict red blood cell transfusion protocol was used in all patients .
RESULTS	There were no significant differences between intra-operative packed red blood cells infusion in the studied groups ( 1.01.4 in fibrinogen group , and 1.31.1 in control group ) .
RESULTS	Less postoperative bleeding was observed in the fibrinogen group ( 477143 versus 703179 , p = 0.0001 ) .
RESULTS	Fifteen patients in the fibrinogen group and 21 in the control group required post-op packed red blood cells infusion ( p = 0.094 ) .
RESULTS	No thrombotic event was observed through 72 h after surgery .
CONCLUSIONS	Prophylactic fibrinogen reduces post-operative bleeding in patients undergoing coronary artery bypass graft .

###24360521
OBJECTIVE	We conducted a competitive efficacy trial in order to examine whether grafting the raw area of the urethral plate ( UP ) with inner preputial skin in children with primary hypospadias ( PH ) during tubularized incised plate urethroplasty ( TIP ) improves the results of the operation .
METHODS	Fifty consecutive patients with pathology ranging from glanular to proximal penile PH were randomized into two groups , comparable for age and pathology , to be operated on either with TIP or a grafted TIP ( G-TIP ) procedure .
METHODS	Three patients failed the re-examination protocol , so the TIP group comprised 23 children aged 9.0 months-9 .6 years ( mean age 3.4 years ) and the G-TIP group comprised 24 children , aged 10.0 months-9 .4 years ( mean 3.5 years ) .
METHODS	The patients were followed up for a period of 2-5 years ( mean 3.2 years ) .
RESULTS	Within the TIP group , we observed the development of fistula with concomitant neourethral stenosis in two cases ( 8.7 % ) , stenosis without fistula in four ( 17.4 % ) , and glans dehiscence in one case ( 4.35 % ) .
RESULTS	Within the G-TIP group there was one case of fistula without stenosis ( 4.16 % ) , no case of neourethral stenosis , and one case of glans dehiscence ( 4.16 % ) .
RESULTS	Two cases of non-slit-like meatus were observed in the TIP group .
RESULTS	The results show that the complications of neourethral stenosis are significantly reduced ( p < 0.05 ) in the G-TIP group , as is the total number of complications and unsatisfactory results .
RESULTS	The duration of the TIP operation was 72-110 ( mean 92 ) min , and for the G-TIP 100-136 ( mean 115 ) min .
RESULTS	No postoperative symptoms were observed that could be attributed to prolonged anesthesia time .
CONCLUSIONS	UP grafting with inner preputial skin , when added to the TIP procedure in the treatment of PH , results in a significantly smaller number of unsatisfactory results , and particularly fewer cases of neourethral stenosis .
CONCLUSIONS	G-TIP can be used as the procedure of choice in PH patients .

###25406046
OBJECTIVE	It has been suggested that the anticonvulsant drug pregabalin may be useful in some anxiety disorders .
OBJECTIVE	The goal of this study was to evaluate the effectiveness of pregabalin augmentation of standard treatment ( selective serotonin reuptake inhibitors and sodium valproate ) for patients with chronic posttraumatic stress disorder ( PTSD ) .
METHODS	This doubleblind , placebo-controlled clinical trial was conducted at Ibn-E-Sina Psychiatric Hospital ( Mashhad , Iran ) in 2013 .
METHODS	Thirty-seven male patients diagnosed with combat-related PTSD based on DSM-IV-TR criteria were randomly assigned to two groups : 18 patients , the case group , received pregabalin ( 300 mg/day ) while 19 patients , the control group , received placebo for 6 weeks .
METHODS	Assessments were done at baseline and at 2 , 4 , and 6 weeks after the onset of treatment , using the PTSD Check List-Military Version ( PCL-M ) , the Hamilton Depression Rating Scale , the Hamilton Anxiety Rating Scale , and the Spitzer Quality of Life Index .
RESULTS	Pregabalin was just significantly effective in improving PCL-M scores ( p = 0.045 ) in comparison to placebo .
RESULTS	Although depression and anxiety scores diminished significantly in both groups ( p = 0.001 and 0.0001 , respectively ) , comparison of the efficacy of pregabalin and placebo did not show significant differences in depression , anxiety , and quality of life scores ( p = 0.614 , 0.144 , and 0.076 , respectively ) .
CONCLUSIONS	Pregabalin effectively reduced the severity of PTSD symptoms but it was not effective in improving the severity of depression , anxiety , and quality of life .
CONCLUSIONS	Further investigations are required to confirm or refute these findings .

###25820113
OBJECTIVE	To compare the effects of local anesthetic intraperitoneal nebulization with intraperitoneal instillation during laparoscopic ovarian cystectomy on postoperative morphine consumption and pain .
METHODS	Multicenter , randomized , case-control trial .
METHODS	Canadian Task Force Classification I.
METHODS	University hospitals in Italy .
METHODS	One hundred forty patients scheduled for laparoscopic ovarian cystectomy .
METHODS	Patients were randomized to receive either nebulization of ropivacaine 150 mg before surgery or instillation of ropivacaine 150 mg before surgery .
METHODS	Nebulization was performed using the Aeroneb Pro device ( Aerogen , Galway , Ireland ) .
RESULTS	One hundred forty patients were enrolled , and 123 completed the study .
RESULTS	There was no difference between the 2 groups in average morphine consumption ( 7.3 7.5 mg in the nebulization group vs 9.2 7.2 mg in the instillation group ; p = .17 ) .
RESULTS	Eighty-two percent of patients in the nebulization group required morphine compared with 96 % in the instillation group ( p < .05 ) .
RESULTS	Patients receiving nebulization had a lower dynamic Numeric Ranking Scale compared with those in the instillation group in the postanesthesia care unit postanesthesia care unit and 4 hours after surgery ( p < .05 ) .
RESULTS	Ten patients ( 15 % ) in the nebulization group experienced shivering in the postanesthesia care unit compared with 2 patients ( 4 % ) in the instillation group ( p = .035 ) .
CONCLUSIONS	Nebulization of ropivacaine prevents the use of morphine in a significant proportion of patients , reduced postoperative pain during the first hours after surgery , and was associated with a higher incidence of postoperative shivering when compared with instillation .

###25427845
BACKGROUND	Since 2007 , the Australian Know your numbers ( KYN ) program has been used in community settings to raise awareness about blood pressure and stroke .
BACKGROUND	In 2011 , the program was modified to include assessment for type 2 diabetes risk .
BACKGROUND	However , it is unclear which approach for assessing diabetes risk in pharmacies is best .
BACKGROUND	We compared two methods : random ( non-fasting ) blood glucose testing ( RBGT ) ; and the Australian type 2 diabetes risk assessment tool ( AUSDRISK ) ; according to 1 ) identification of ` high risk ' participants including head-to-head sensitivity and specificity ; 2 ) number of referrals to doctors ; and 3 ) feasibility of implementation .
METHODS	117 Queensland pharmacies voluntarily participated and were randomly allocated to RBGT and AUSDRISK or AUSDRISK only .
METHODS	Although discouraged , pharmacies were able to change allocated group prior to commencement .
METHODS	AUSDRISK is a validated self-administered questionnaire used to calculate a score that determines the 5-year risk of developing type 2 diabetes .
METHODS	AUSDRISK ( score 12 + ) or RBGT ( 5.6 mmol/I ) indicates a high potential risk of diabetes .
METHODS	Median linear regression was used to compare the two measures .
METHODS	Staff from 68 pharmacies also participated in a semi-structured interview during a site visit to provide feedback .
RESULTS	Data were submitted for 5,483 KYN participants ( 60 % female , 66 % aged > 55 years , 10 % history of diabetes ) .
RESULTS	Approximately half of the participants without existing diabetes were identified as ` high risk ' based on either RBGT or AUSDRISK score .
RESULTS	Among participants who undertook both measures , 32 % recorded a high RBGT and high AUSDRISK .
RESULTS	There was a significant association between RBGT and AUSDRISK scores .
RESULTS	For every one point increase in AUSDRISK score there was a half point increase in RBGT levels ( coefficient 0.55 , 95 % CI : 0.28 , 0.83 ) .
RESULTS	Pharmacy staff reported that AUSDRISK was a simple , low cost and efficient method of assessing diabetes risk compared with RBGT , e.g. since management of sharps is not an issue .
CONCLUSIONS	In a large , community-based sample of Australians about half of the participants without diabetes were at ` high risk ` of developing diabetes based on either AUSDRISK or RBGT results .
CONCLUSIONS	AUSDRISK was considered to be an acceptable method for assessing the risk of diabetes using opportunistic health checks in community pharmacies .

###25296655
BACKGROUND	Nursing home residents often have a high number of comorbidities resulting in polypharmacy .
BACKGROUND	Inappropriate prescribing is therefore likely to occur , which in turn is expected to worsen cognitive impairment , to increase the fall risk and to decrease residents ' quality of life .
BACKGROUND	The objective of the ` Discontinuing Inappropriate Medication in Nursing Home Residents ' ( DIM-NHR ) study is to examine the efficacy and cost-effectiveness of the Multidisciplinary Multistep Medication Review ( 3MR ) that is aimed at optimising prescribing and discontinuing inappropriate medication .
METHODS	A cluster randomised controlled trial will be conducted .
METHODS	Elderly care physicians and their wards ( clusters ) will be randomised .
METHODS	Data will be collected at baseline and 4months after the 3MR has taken place .
METHODS	Six hundred nursing home residents will be recruited of whom more than half are expected to suffer from dementia .
METHODS	The 3MR will be based on consensus criteria and the relevant literature and will be performed by the patient 's elderly care physician in collaboration with a pharmacist .
METHODS	Primary outcomes-the difference in proportion of residents who successfully discontinued inappropriate medication between the intervention and control group at follow-up .
METHODS	Secondary outcomes-undertreatment , exposure to anticholinergic and sedative medicines , neuropsychiatric symptoms , cognitive function , falls , hospital admission , quality of life and cost-effectiveness .
BACKGROUND	Participant burden will be kept at a minimum .
BACKGROUND	The elderly care physician will remain free to adjust medication when symptoms relapse or adverse events occur , rendering serious adverse events highly unlikely .
BACKGROUND	Study findings will be published in peer-reviewed journals and a 3MR toolkit will be developed .
BACKGROUND	This study has been registered at http://www.ClinicalTrials.gov ( trial registration number : NCT01876095 ) .

###24925984
BACKGROUND	Long-acting injectable formulations of antipsychotics are treatment alternatives to oral agents .
OBJECTIVE	To assess the efficacy of aripiprazole once-monthly compared with oral aripiprazole for maintenance treatment of schizophrenia .
METHODS	A 38-week , double-blind , active-controlled , non-inferiority study ; randomisation ( 2:2:1 ) to aripiprazole once-monthly 400 mg , oral aripiprazole ( 10-30 mg/day ) or aripiprazole once-monthly 50 mg ( a dose below the therapeutic threshold for assay sensitivity ) .
BACKGROUND	clinicaltrials.gov , NCT00706654 . )
RESULTS	A total of 1118 patients were screened , and 662 responders to oral aripiprazole were randomised .
RESULTS	Kaplan-Meier estimated impending relapse rates at week 26 were 7.12 % for aripiprazole once-monthly 400 mg and 7.76 % for oral aripiprazole .
RESULTS	This difference ( -0.64 % , 95 % CI -5.26 to 3.99 ) excluded the predefined non-inferiority margin of 11.5 % .
RESULTS	Treatments were superior to aripiprazole once-monthly 50 mg ( 21.80 % , P < or = 0.001 ) .
CONCLUSIONS	Aripiprazole once-monthly 400 mg was non-inferior to oral aripiprazole , and the reduction in Kaplan-Meier estimated impending relapse rate at week 26 was statistically significant v. aripiprazole once-monthly 50 mg .

###24252648
BACKGROUND	Persons with serious mental illness ( SMI ) are disproportionately burdened by premature mortality .
BACKGROUND	This disparity is exacerbated by poor continuity of care with the health system .
BACKGROUND	The Veterans Health Administration ( VA ) developed Re-Engage , an effective population-based outreach program to identify veterans with SMI lost to care and to reconnect them with VA services .
BACKGROUND	However , such programs often encounter barriers getting implemented into routine care .
BACKGROUND	Adaptive designs are needed when the implementation intervention requires augmentation within sites that do not initially respond to an initial implementation intervention .
BACKGROUND	This protocol describes the methods used in an adaptive implementation design study that aims to compare the effectiveness of a standard implementation strategy ( Replicating Effective Programs , or REP ) with REP enhanced with External Facilitation ( enhanced REP ) to promote the uptake of Re-Engage .
METHODS	This study employs a four-phase , two-arm , longitudinal , clustered randomized trial design .
METHODS	VA sites ( n = 158 ) across the United States with a designated Re-Engage provider , at least one Veteran with SMI lost to care , and who received standard REP during a six-month run-in phase .
METHODS	Subsequently , 88 sites with inadequate uptake were stratified at the cluster level by geographic region ( n = 4 ) and VA regional service network ( n = 20 ) and randomized to REP ( n = 49 ) vs. enhanced REP ( n = 39 ) in phase two .
METHODS	The primary outcome was the percentage of veterans on each facility outreach list documented on an electronic web registry .
METHODS	The intervention was at the site and network level and consisted of standard REP versus REP enhanced by external phone facilitation consults .
METHODS	At 12 months , enhanced REP sites returned to standard REP and 36 sites with inadequate participation received enhanced REP for six months in phase three .
METHODS	Secondary implementation outcomes included the percentage of veterans contacted directly by site providers and the percentage re-engaged in VA health services .
CONCLUSIONS	Adaptive implementation designs consisting of a sequence of decision rules that are tailored based on a site 's uptake of an effective program may produce more relevant , rapid , and generalizable results by more quickly validating or rejecting new implementation strategies , thus enhancing the efficiency and sustainability of implementation research and potentially leading to the rollout of more cost-efficient implementation strategies .
BACKGROUND	Current Controlled Trials ISRCTN21059161 .

###24473534
OBJECTIVE	This study aims to obtain preliminary data on the efficacy of yoga for reducing self-reported menopausal hot flashes in a randomized study including an attention control group .
METHODS	We randomized 54 late perimenopausal women ( 2-12 mo of amenorrhea ) and postmenopausal women ( > 12 mo of amenorrhea ) -- aged 45 to 58 years and who experienced at least four hot flashes per day , on average , for at least 4 weeks -- to one of three groups : yoga , health and wellness education ( HW ) , and wait list ( WL ) .
METHODS	Yoga and HW classes consisted of weekly 90-minute classes for 10 weeks .
METHODS	All women completed daily hot flash diaries throughout the trial ( 10 wk ) to track the frequency and severity of hot flashes .
METHODS	The mean hot flash index score is based on the number of mild , moderate , severe , and very severe hot flashes .
RESULTS	Hot flash frequency declined significantly across time for all three groups , with the strongest decline occurring during the first week .
RESULTS	There was no overall significant difference in hot flash frequency decrease over time by treatment groups , but the yoga and HW groups followed similar patterns and showed greater decreases than the WL group .
RESULTS	On week 10 , women in the yoga group reported an approximately 66 % decrease in hot flash frequency , women in the HW group reported a 63 % decrease , and women in the WL group reported a 36 % decrease .
RESULTS	The hot flash index showed a similar pattern .
CONCLUSIONS	Results suggest that yoga can serve as a behavioral option for reducing hot flashes but may not offer any advantage over other types of interventions .

###25049338
OBJECTIVE	Symptoms of posttraumatic stress disorder are a well-recognized phenomenon in mothers of preterm infants , with implications for maternal health and infant outcomes .
OBJECTIVE	This randomized controlled trial evaluated 6-month outcomes from a skills-based intervention developed to reduce symptoms of posttraumatic stress disorder , anxiety , and depression .
METHODS	One hundred five mothers of preterm infants were randomly assigned to ( 1 ) a 6 - or 9-session intervention based on principles of trauma-focused cognitive behavior therapy with infant redefinition or ( 2 ) a 1-session active comparison intervention based on education about the NICU and parenting of the premature infant .
METHODS	Outcome measures included the Davidson Trauma Scale , the Beck Depression Inventory II , and the Beck Anxiety Inventory .
METHODS	Participants were assessed at baseline , 4 to 5 weeks after birth , and 6 months after the birth of the infant .
RESULTS	At the 6-month assessment , the differences between the intervention and comparison condition were all significant and sizable and became more pronounced when compared with the 4 - to 5-week outcomes : Davidson Trauma Scale ( Cohen 's d = -0.74 , P < .001 ) , Beck Anxiety Inventory ( Cohen 's d = -0.627 , P = .001 ) , Beck Depression Inventory II ( Cohen 's d = -0.638 , P = .002 ) .
RESULTS	However , there were no differences in the effect sizes between the 6 - and 9-session interventions .
CONCLUSIONS	A brief 6-session intervention based on principles of trauma-focused cognitive behavior therapy was effective at reducing symptoms of trauma , anxiety , and depression in mothers of preterm infants .
CONCLUSIONS	Mothers showed increased benefits at the 6-month follow-up , suggesting that they continue to make use of techniques acquired during the intervention phase .

###25034716
OBJECTIVE	Diabetes mellitus is an independent risk factor for lacunar strokes .
OBJECTIVE	Few data are available regarding patient features , infarct location , and recurrent vascular events for patients with diabetes mellitus with lacunar stroke .
METHODS	We compared features at study entry and prognosis during 3.6 years of follow-up of patients with diabetes mellitus versus patients without diabetes mellitus with recent lacunar stroke participating in the Secondary Prevention of Small Subcortical Strokes ( SPS3 ) randomized trial .
RESULTS	Among the 3020 participants , the prevalence of diabetes mellitus was 37 % with a mean duration of 11 years .
RESULTS	Diabetes mellitus was independently associated with slightly younger age ( 63 versus 64 years ; P < 0.001 ) , Hispanic ethnicity ( 36 % versus 28 % ; P < 0.0001 ) , ischemic heart disease ( 11 % versus 6 % ; P = 0.002 ) , and peripheral vascular disease ( 5 % versus 2 % ; P < 0.001 ) .
RESULTS	Patients with diabetes mellitus more frequently had intracranial stenosis 50 % ( P < 0.001 ) , infarcts involving the brain stem or cerebellum ( P < 0.001 ) , and more extensive white matter abnormalities ( P < 0.001 ) .
RESULTS	Patients with diabetes mellitus were almost twice as likely to have a recurrent stroke ( hazard ratio [ HR ] , 1.8 ; 95 % confidence interval [ CI ] , 1.4-2 .3 ) , recurrent ischemic stroke ( HR , 1.8 ; 95 % CI , 1.4-2 .4 ) , disabling/fatal stroke ( HR , 1.8 ; 95 % CI , 1.2-2 .9 ) , myocardial infarction ( HR , 1.7 ; 95 % CI , 1.0-2 .8 ) , and death ( HR , 2.1 95 % CI , 1.6-2 .8 ) compared with patients without diabetes mellitus .
CONCLUSIONS	Patients with diabetes mellitus with lacunar stroke have a distinctive clinical profile that includes double the prevalence of systemic and intracranial atherosclerosis , preferential involvement of the posterior circulation , and a poor prognosis for recurrent stroke and death .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00059306 .

###24789375
OBJECTIVE	Initial treatment for amblyopia of the fellow eye with patching and atropine sulfate eyedrops improves visual acuity .
OBJECTIVE	Long-term data on the durability of treatment benefit are needed .
OBJECTIVE	To report visual acuity at 15 years of age among patients who were younger than 7 years when enrolled in a treatment trial for moderate amblyopia .
METHODS	In a multicenter clinical trial , 419 children with amblyopia ( visual acuity , 20/40 to 20/100 ) were randomly assigned to patching ( minimum of 6 h/d ) or atropine sulfate eyedrops , 1 % ( 1 drop daily ) , for 6 months .
METHODS	Treatment after 6 months was at the discretion of the investigator .
METHODS	Two years after enrollment , an unselected subgroup of 188 children were enrolled into long-term follow-up .
METHODS	Initial treatment with patching or atropine with subsequent treatment at investigator discretion .
METHODS	Visual acuity at 15 years of age with the electronic Early Treatment Diabetic Retinopathy Study test in amblyopic and fellow eyes .
RESULTS	Mean visual acuity in the amblyopic eye measured in 147 participants at 15 years of age was 0.14 logMAR ( approximately 20/25 ) ; 59.9 % of amblyopic eyes had visual acuity of 20/25 or better and 33.3 % , 20/20 or better .
RESULTS	Mean interocular acuity difference ( IOD ) at 15 years of age was 0.21 logMAR ( 2.1 lines ) ; 48.3 % had an IOD of 2 or more lines and 71.4 % , 1 or more lines .
RESULTS	Treatment ( other than spectacles ) was prescribed for 9 participants ( 6.1 % ) aged 10 to 15 years .
RESULTS	Mean IOD was similar at examinations at 10 and 15 years of age ( 2.0 and 2.1 logMAR lines , respectively ; P = .39 ) .
RESULTS	Better visual acuity at the 15-year examination was achieved in those who were younger than 5 years at the time of entry into the randomized clinical trial ( mean logMAR , 0.09 ) compared with those aged 5 to 6 years ( mean logMAR , 0.18 ; P < .001 ) .
RESULTS	When we compared subgroups based on original treatment with atropine or patching , no significant differences were observed in visual acuity of amblyopic and fellow eyes at 15 years of age ( P = .44 and P = .43 , respectively ) .
CONCLUSIONS	At 15 years of age , most children treated for moderate amblyopia when younger than 7 years have good visual acuity , although mild residual amblyopia is common .
CONCLUSIONS	The outcome is similar regardless of initial treatment with atropine or patching .
CONCLUSIONS	The results indicate that improvement occurring with amblyopia treatment is maintained until at least 15 years of age .
BACKGROUND	clinicaltrials.gov Identifier : NCT00000170 .

###24610180
BACKGROUND	Total knee replacement ( TKR ) is a cost-effective treatment option for severe osteoarthritis ( OA ) .
BACKGROUND	While prevalence of OA is higher among blacks than whites , TKR rates are lower among blacks .
BACKGROUND	Physicians ' implicit preferences might explain racial differences in TKR recommendation .
BACKGROUND	The objective of this study was to evaluate whether the magnitude of implicit racial bias predicts physician recommendation of TKR for black and white patients with OA and to assess the effectiveness of a web-based instrument as an intervention to decrease the effect of implicit racial bias on physician recommendation of TKR .
METHODS	In this web-based study , 543 family and internal medicine physicians were given a scenario describing either a black or white patient with severe OA refractory to medical treatment .
METHODS	Questionnaires evaluating the likelihood of recommending TKR , perceived medical cooperativeness , and measures of implicit racial bias were administered .
METHODS	The main outcome measures included TKR recommendation , implicit racial preference , and medical cooperativeness stereotypes measured with implicit association tests .
RESULTS	Subjects displayed a strong implicit preference for whites over blacks ( P < .0001 ) and associated `` medically cooperative '' with whites over blacks ( P < .0001 ) .
RESULTS	Physicians reported significantly greater liking for whites over blacks ( P < .0001 ) and reported believing whites were more medically cooperative than blacks ( P < .0001 ) .
RESULTS	Participants reported providing similar care for white and black patients ( P = .10 ) but agreed that subconscious biases could influence their treatment decisions ( P < .0001 ) .
RESULTS	There was no significant difference in the rate of recommendation for TKR when the patient was black ( 47 % ) versus white ( 38 % ) ( P = .439 ) , and neither implicit nor explicit racial biases predicted differential treatment recommendations by race ( all P > .06 ) .
RESULTS	Although participants were more likely to recommend TKR when completing the implicit association test before the decision , patient race was not significant in the association ( P = .960 ) .
CONCLUSIONS	Physicians possessed explicit and implicit racial biases , but those biases did not predict treatment recommendations .
CONCLUSIONS	Clinicians ' biases about the medical cooperativeness of blacks versus whites , however , may have influenced treatment decisions .

###24784763
BACKGROUND	Antiretroviral pre-exposure prophylaxis ( PrEP ) is a novel HIV prevention strategy for which adherence is a known determinant of efficacy .
BACKGROUND	Blood concentrations of PrEP medications are one objective marker of adherence .
METHODS	In a placebo-controlled PrEP efficacy trial of tenofovir disoproxil fumarate ( TDF ) and TDF with emtricitabine ( FTC/TDF ) among 4747 African women and men with an HIV-infected partner , we measured plasma tenofovir concentrations from participants in the active PrEP arms : 29 HIV seroconverters ( cases ) and 196 randomly selected controls who remained uninfected .
RESULTS	Among controls , 71 % of visits had tenofovir concentrations > 40 ng/mL , consistent with steady-state daily dosing , compared with 21 % of cases at the visit HIV was first detected .
RESULTS	Pill count data indicated that 96 % of controls and 66 % of cases had > 80 % adherence for these same visits .
RESULTS	The estimated protective effect of PrEP against HIV , based on concentrations > 40 ng/mL , was 88 % ( 95 % confidence interval : 60 to 96 , P < 0.001 ) for individuals receiving TDF and 91 % ( 95 % confidence interval : 47 to 98 , P = 0.008 ) for individuals receiving FTC/TDF .
RESULTS	Controls had consistent patterns of PrEP concentrations during follow-up ; among the 81 % with concentrations > 40 ng/mL at month 1 , 75 % maintained this concentration at month 12 .
RESULTS	Only 5 of 29 seroconverters seemed to be consistently adherent to PrEP .
RESULTS	Tenofovir concentrations > 40 ng/mL were associated with older age and shorter time on study ; concentrations 40 ng/mL occurred more commonly when participants reported no sex with their HIV-infected partner .
CONCLUSIONS	Plasma concentrations of tenofovir consistent with daily dosing were highly predictive of protection from HIV acquisition .
CONCLUSIONS	Most of those who took PrEP seemed to have high and consistent adherence .

###24456677
BACKGROUND	Postoperative vision loss complicates an estimated 1 in 1,100 prone spine surgical cases .
BACKGROUND	This complication has been attributed to ischemic optic neuropathy , with one proposed reason being perioperative elevations in intraocular pressure ( IOP ) .
BACKGROUND	Previous research has studied the effects of table inclination on IOP in awake volunteers ; however , the effects in spine surgery patients have not been investigated for reverse Trendelenburg positioning using a prospective , randomized controlled study design .
OBJECTIVE	To assess the effect of table inclination on IOP in patients undergoing prone spine surgery .
METHODS	Single-center , prospective randomized controlled study .
METHODS	Nineteen patients with no history of eye pathology , undergoing prone spine surgery at Dwight D. Eisenhower Army Medical Center , were randomly assigned to a table position : neutral , 5 , or 10 of reverse Trendelenburg .
METHODS	Intraocular pressure , mean arterial pressure ( MAP ) , estimated blood loss , fluid resuscitation , and ophthalmologic complication were assessed before and after induction and at incremental times during surgery , beginning at 30 minutes , 60 minutes , and 60-minute increments thereafter .
METHODS	Multivariate analyses evaluated surgical time , IOP , MAP , estimated blood loss , and fluid resuscitation as a function of table inclination to determine the effect of patient positioning on identified risk factors for postoperative vision loss .
RESULTS	Surgical times ranged from 33 to 325 minutes .
RESULTS	A rapid increase in IOP was noted after prone positioning , with continued increases as time elapsed .
RESULTS	The neutral group exhibited statistically higher IOP compared with the 5 reverse Trendelenburg group after 60 minutes and the 10 group through 60 minutes of surgery .
RESULTS	The trend continued through 120 minutes ; however , because of a lack of power , we were unable to determine the statistical significance .
RESULTS	There were no statistically significant differences between the 5 and 10 reverse Trendelenburg groups .
CONCLUSIONS	Reverse Trendelenburg positioning elicits decreased IOP compared with prone positioning for surgery times less than 120 minutes .
CONCLUSIONS	Ten degrees of reverse Trendelenburg attenuate the rise in IOP during prone spine surgery superiorly in comparison with 5 .
CONCLUSIONS	No significant complications were associated with reverse Trendelenburg positioning .

###25012072
OBJECTIVE	We aimed to examine the efficacy of two psycho-oncological interventions in anxiety , depression , and self-perceived as well as physiological stress in inpatients with gynaecological cancer .
METHODS	Forty-five women were included in the trial .
METHODS	Thirty-five were categorized as being at high risk of anxiety and depression , and were randomized to either a single psycho-oncological therapy session or a single-session relaxation intervention .
RESULTS	A significant decrease in anxiety [ mean ( t0 ) = 12 , mean ( t1 ) = 7.47 , p = 0.001 ] and depression [ mean ( t0 ) = 9.71 , mean ( t1 ) = 6.35 , p < 0.001 ] was observed in the psycho-oncological intervention group .
RESULTS	In the relaxation group , anxiety also significantly decreased [ mean ( t0 ) = 11.67 , mean ( t1 ) = 8.22 , p = 0.003 ] , whereas depression did not .
RESULTS	A comparative analysis of both interventions showed a trend in favour of psycho-oncological therapy for the treatment of depression ( F = 3.3 , p = 0.078 ) .
RESULTS	However , self-reported stress ( p = 0.031 ) and different objective stress parameters only significantly decreased in the relaxation group .
CONCLUSIONS	Psycho-oncological interventions should represent an essential part of interdisciplinary care for gynaecological cancer patients .
CONCLUSIONS	Both types of intervention may reduce anxiety .
CONCLUSIONS	However , the single psycho-oncological therapy session might be slightly more effective in treating depression , whereas the single-session relaxation intervention seems to have a stronger effect on physiological stress parameters .

###25160516
BACKGROUND	Cash transfers ( CTs ) are increasingly used as a strategy to alleviate poverty and improve child health outcomes in low - and middle-income countries .
BACKGROUND	The Child Support Grant ( CSG ) is the largest CT programme in South Africa , and on the continent , targeting poor children from birth until the age of 18 with a monthly sum of R300 ( USD30 ) .
BACKGROUND	Evidence on the CSG shows that early receipt of the grant is associated with improved child health outcomes .
BACKGROUND	Since its implementation , one of the major concerns about the grant has been take-up rates , particularly for younger children .
BACKGROUND	This paper reports results on take-up rates for 12-week-old infants residing in an urban township in South Africa .
METHODS	This is a descriptive study utilising data from a community-based , cluster-randomised trial which evaluated a programme providing pregnancy and post-natal home visits by community health workers to 3,494 mothers in Umlazi township , South Africa .
RESULTS	At the 12-week visit , half ( 52 % ) of the mothers who had enrolled in the study had applied for the CSG on behalf of their children , while 85 % of the mothers who had not applied were still planning to apply .
RESULTS	Only 38 % ( 1,327 ) of all children had received the CSG .
CONCLUSIONS	In this study , many mothers had not applied for the CSG in the first few months after delivery , and only a third of children had accessed the grant .
CONCLUSIONS	Further research is needed to understand what the current barriers are that prevent mothers from applying for this important form of social protection in the early months after delivery .

###25632577
OBJECTIVE	To observe the therapeutic effect of different schemes of mild moxibustion for treatment of ( yang-deficiency induced cold-accumulation type ) knee osteoarthritis ( KOA ) .
METHODS	Fifty-nine KOA patients were chosen and randomly divided into control group ( n = 30 ) and test group ( n = 29 ) .
METHODS	Patients of the control group were treated by mild moxi - bustion of Neixiyan ( EX-HE4 ) and Waixiyan ( ST 35 ) for 30 min , once daily for 14 days ( two courses ) , and those of the test group were treated by mild moxibustion of EX-HE 4 and ST 35 for 30 mini once daily for 7 days ( the same to control group ) , followed by moxibustion of Yaoyangguan ( GV 3 ) and Mingmen ( GV 4 ) once daily for next 7 days more .
METHODS	In addition , patients of the two groups were also treated by routine acupuncture stimulation of EX-HE 4 , ST 35 , Yanglingquan ( GB 34 ) , Kunlun ( BL 60 ) , etc. .
METHODS	The interval between two therapeutic courses was one day .
METHODS	The Lysholm Knee Score Scale ( LKSS ) was used to evaluate the therapeutic effect .
METHODS	Visual analogue scale ( VAS ) was employed to assess the patient 's knee-joint pain severity ( arthralgia ) , and scores of morning stiffness , arthrocele , and walking restraint degree of the knee-joint were also evaluated before and after the treatment .
RESULTS	After the treatment , the scores of VAS , morning stiffness , arthrocele and walking restraint degree of the knee-joint of both groups were significantly decreased ( P < 0.05 ) , and the scores of the test group were obviously lower than those of the con - trol group ( P < 0.05 ) .
RESULTS	The effective rate of the test group was 89.66 % ( 26/29 ) which was obviously higher than that ( 70.00 % , 21/30 ) of the control group ( P < 0.05 ) .
CONCLUSIONS	Mild moxibustion of Neixiyan ( EX-HE 4 ) and Waixiyan ( ST 35 , local acu - points ) , and Yaoyangguan ( GV 3 ) and Mingmen ( GV 4 ) has a better therapeutic effect for KOA patients than moxibustion of local acupoints only .

###25208199
OBJECTIVE	Despite the commonly observed comorbidity of alcohol and tobacco use disorders and years of research , the mechanism underlying concurrent use of alcohol and tobacco is not yet clear .
OBJECTIVE	In this study , we used functional magnetic resonance imaging ( fMRI ) to investigate the relationship between brain responses to alcohol and smoking cues in 45 subjects with episodic drinking and regular smoking .
METHODS	fMRI data were collected from two studies performing an alcohol-craving task and a smoking-craving task .
METHODS	First , we identified brain voxels significantly activated for both substance cues and then associated the activation of these voxels with various alcohol - and nicotine-dependence measures .
METHODS	Significant clusters ( cluster-wise p < .05 ) correlated with behavioral assessments were extracted , and clusters identified from both cues were compared .
RESULTS	The association tests with various dependence scores showed that the loss of behavioral control subcategory in the Alcohol Dependence Scale was significantly correlated with brain activation of the posterior cingulate cortex ( PCC ) and right posterior insula regardless of cue types .
CONCLUSIONS	Our findings suggest that the PCC and right posterior insula , each playing a role in the salience network , are affected significantly by impaired control for alcohol and in turn influence brain responses to not only alcohol but also smoking cues , providing insight to neuronal mechanisms for concurrent use or comorbidity of alcohol and nicotine dependence .

###24428461
OBJECTIVE	To test the effectiveness of tailored quitline ( telephone ) counselling among smoking parents recruited into cessation support through their children 's primary schools .
METHODS	Two-arm randomized controlled trial with 3 - and 12-month follow-up .
METHODS	Proactive telephone counselling was administered by the Dutch national quitline .
METHODS	Smoking parents were recruited through their children 's primary schools and received either intensive quitline support in combination with tailored supplementary materials ( n = 256 ) or a standard self-help brochure ( n = 256 ) .
METHODS	The primary outcome was 7-day point-prevalence abstinence at 12-month follow-up .
METHODS	Also measured were baseline characteristics , use of and adherence to nicotine replacement therapy and pharmacotherapy , smoking characteristics and implementation of a home smoking ban .
RESULTS	Parents who received quitline counselling were more likely to report 7-day point-prevalence abstinence at 12-month assessment [ 34.0 versus 18.0 % , odds ratio ( OR ) = 2.35 , confidence interval ( CI ) = 1.56-3 .54 ] than those who received a standard self-help brochure .
RESULTS	Parents who received quitline counselling were more likely to use nicotine replacement therapy ( P < 0.001 ) than those who received a standard self-help brochure .
RESULTS	Among parents who did not achieve abstinence , those who received quitline counselling smoked fewer cigarettes at 3-month ( P < 0.001 ) and 12-month assessment ( P < 0.001 ) , were more likely to make a quit attempt ( P < 0.001 ) , to achieve 24 hours ' abstinence ( P < 0.001 ) and to implement a complete home smoking ban ( P < 0.01 ) .
CONCLUSIONS	Intensive quitline support tailored to smoking parents is an effective method for helping parents quit smoking and promoting parenting practices that protect their children from adverse effects of smoking .

###26337307
BACKGROUND	Prescription of generic products is a way to reduce health expense .
BACKGROUND	Bioequivalence is the most appropriate procedure to evaluate the quality and therapeutic efficacy of a generic product .
BACKGROUND	Generic prescriptions are a strategic choice in Tunisia .
OBJECTIVE	We expose in this work , a bioequivalence study witch compare a generic ( test ) product : DIABENIL * manufactured by a Tunisian pharmaceutical industry Dar Essaidaly to the innovative ( reference ) product : DAONIL * of Aventis pharma laboratories .
METHODS	The bioequivalence of two glibenclamide 5-mg tablets was determined in healthy human , adult volunteers after a single dose in a randomized cross-over in double blind study .
METHODS	Test and reference were administered to twenty-four healthy volunteers of both sexes after overnight fasting .
METHODS	In total , 15 Blood samples were collected before and following the administration of the drug .
METHODS	Serum concentrations of glibenclamide were determined by validated HPLC method .
METHODS	The pharmacokinetic parameters AUC0t , AUC0 , Cmax and tmax were tested for bioequivalence .
RESULTS	All parameters showed bioequivalence between both formulations as their confidence intervals were within the bioequivalence acceptable range of 0.80-1 .25 limits .
CONCLUSIONS	We conclude that the two formulations exhibited comparable pharmacokinetic profiles and that the two products can be considered interchangeable in medical practice .

###24399647
BACKGROUND	Because lithium exerts neuroprotective effects in preclinical models of polyglutamine disorders , our objective was to assess the safety and efficacy of lithium carbonate ( 0.5-0 .8 milliequivalents per liter ) in patients with Machado-Joseph disease ( spinocerebellar ataxia type 3 [ MJD/SCA3 ] ) .
METHODS	For this phase 2 , single-center , double-blind , parallel , placebo-controlled trial ( ClinicalTrials.gov identifier NCT01096082 ) , 62 patients who had MJD/SCA3 with a disease duration 10 years and an independent gait were randomly assigned ( 1:1 ) to receive either lithium or placebo .
RESULTS	After 24 weeks , 169 adverse events were reported , including 50.3 % in the lithium group ( P = 1.00 ; primary safety outcome ) .
RESULTS	Sixty patients ( 31 in the placebo group and 29 in the lithium group ) were analyzed for efficacy ( intention-to-treat analysis ) .
RESULTS	Mean progression between groups did not differ according to scores on the Neurological Examination Score for the Assessment of Spinocerebellar Ataxia ( NESSCA ) after 48 weeks ( -0.35 ; 95 % confidence interval , -1.7 to 1.0 ; primary efficacy outcome ) .
RESULTS	The lithium group exhibited minor progression on the PATA speech-rate ( P = 0.002 ) , the nondominant Click Test ( P = 0.023 ) , the Spinocerebellar Ataxia Functional Index ( P = 0.003 ) , and the Composite Cerebellar Functional Score ( P = 0.029 ) .
CONCLUSIONS	Lithium was safe and well tolerated , but it had no effect on progression when measured using the NESSCA in patients with MJD/SCA3 .
CONCLUSIONS	This slowdown in secondary outcomes deserves further clarification .

###24411083
BACKGROUND	Dihydrotestosterone is the main androgen causative of androgenetic alopecia , a psychologically and physically harmful condition warranting medical treatment .
OBJECTIVE	We sought to compare the efficacy and safety of dutasteride ( type 1 and 2 5-alpha reductase inhibitor ) with finasteride ( type 2 5-alpha reductase inhibitor ) and placebo in men with androgenetic alopecia .
METHODS	Men aged 20 to 50 years with androgenetic alopecia were randomized to receive dutasteride ( 0.02 , 0.1 , or 0.5 mg/d ) , finasteride ( 1 mg/d ) , or placebo for 24 weeks .
METHODS	The primary end point was hair count ( 2.54-cm diameter ) at week 24 .
METHODS	Other assessments included hair count ( 1.13-cm diameter ) and width , photographic assessments ( investigators and panel ) , change in stage , and health outcomes .
RESULTS	In total , 917 men were randomized .
RESULTS	Hair count and width increased dose dependently with dutasteride .
RESULTS	Dutasteride 0.5 mg significantly increased hair count and width in a 2.54-cm diameter and improved hair growth ( frontal view ; panel photographic assessment ) at week 24 compared with finasteride ( P = .003 , P = .004 , and P = .002 , respectively ) and placebo ( all P < .001 ) .
RESULTS	The number and severity of adverse events were similar among treatment groups .
CONCLUSIONS	The study was limited to 24 weeks .
CONCLUSIONS	Dutasteride increased hair growth and restoration in men with androgenetic alopecia and was relatively well tolerated .

###24643055
OBJECTIVE	We aimed to compare the efficacy of isosorbide mononitrate and doxazosin in the treatment of lower urinary tract symptoms ( LUTS ) .
METHODS	80 patients with LUTS were included in this randomized clinical study .
METHODS	All patients were evaluated with uroflowmetry , post-void residual ( PVR ) urine , prostate volume , International Prostate Symptom Score ( IPSS ) , serum PSA , urinalysis and culture .
METHODS	40 patients were prescribed doxazosin for 4 weeks , another 40 were prescribed isosorbide mononitrate for 4 weeks .
METHODS	Urologic re-evaluation was done at the end of the study .
RESULTS	74 patients completed the study .
RESULTS	The mean age of patients was 59.6 0.7 years , the mean PSA value was 1.7 0.1 ng/ml and the mean prostate volume was 41.9 1.7 ml .
RESULTS	Doxazosin markedly improved IPSS ( from 16.2 0.7 to 9.5 0.5 ) , maximum urinary flow rate ( from 10.9 0.7 to 12.8 0.6 ml/s ) and PVR urine ( from 68.1 9.4 to 39.0 4.4 ml ) ( p < 0.0001 , p < 0.0001 , p = 0.0004 , respectively ) .
RESULTS	Isosorbide only improved IPSS ( from 16.5 0.9 to 14.6 0.8 ) ( p = 0.032 ) .
CONCLUSIONS	Daily administration of isosorbide does not seem to be an alternative to - blocker therapy .
CONCLUSIONS	Controlled , randomized novel studies are required to establish that whether nitric oxide donors are an effective alternative in LUTS treatment .

###25699389
OBJECTIVE	Ulinastatin was reported has positive effects on preventing post-ERCP pancreatitis and hyperamylasemia for patients in average risk .
OBJECTIVE	To observe the incidence of post-ERCP pancreatitis and investigate the efficacy and feasibility of using Ulinaststin to prevent post-ERCP pancreatitis .
METHODS	A total of 280 patients were randomized into two arms : an experimental arm using Ulinastatin-containing contrast medium and a control arm using the same contrast medium without Ulinastatin .
METHODS	Blood amylase and urine amylase-2 were measured at three and twenty-four hours after ERCP procedure .
RESULTS	There were distinct differences in the incidence of post-ERCP pancreatitis and average blood amylase levels in the two arms ( p < 0.05 ) .
RESULTS	Post-ERCP pancreatitis was observed in 20 patients ( 7.1 % ) , including 7 ( 4.37 % ) patients in the experimental arm , and 13 ( 10.83 % ) patients in control arm .
RESULTS	After 3 hours of the operation , the average blood amylase levels in control and experimental arm were 224.8234.27 U/L and 189.5220.94 U/L , respectively .
RESULTS	Correspondingly , the levels were 233.5935.05 U/L and 187.0923.14 U/L after 24 hours .
RESULTS	But the difference was not statistically significant in urine amylase-2 levels , hemoleukocyte count and operation time .
CONCLUSIONS	The exploitation of Ulinastatin in ERCP could decrease the incidence but could not completely prevent the development of post-ERCP pancreatitis .

###25138814
BACKGROUND	Malaria due to Plasmodium knowlesi is reported throughout South-East Asia , and is the commonest cause of it in Malaysia .
BACKGROUND	P. knowlesi replicates every 24h and can cause severe disease and death .
BACKGROUND	Current 2010 WHO Malaria Treatment Guidelines have no recommendations for the optimal treatment of non-severe knowlesi malaria .
BACKGROUND	Artemisinin-combination therapies ( ACT ) and chloroquine have each been successfully used to treat knowlesi malaria ; however , the rapidity of parasite clearance has not been prospectively compared .
BACKGROUND	Malaysia 's national policy for malaria pre-elimination involves mandatory hospital admission for confirmed malaria cases with discharge only after two negative blood films ; use of a more rapidly acting antimalarial agent would have health cost benefits .
BACKGROUND	P. knowlesi is commonly microscopically misreported as P. malariae , P. falciparum or P. vivax , with a high proportion of the latter two species being chloroquine-resistant in Malaysia .
BACKGROUND	A unified ACT-treatment protocol would provide effective blood stage malaria treatment for all Plasmodium species .
METHODS	ACT KNOW , the first randomised controlled trial ever performed in knowlesi malaria , is a two-arm open-label trial with enrolments over a 2-year period at three district sites in Sabah , powered to show a difference in proportion of patients negative for malaria by microscopy at 24h between treatment arms ( clinicaltrials.gov #NCT 01708876 ) .
METHODS	Enrolments started in December 2012 , with completion expected by September 2014 .
METHODS	A total sample size of 228 is required to give 90 % power ( 0.05 ) to determine the primary end point using intention-to-treat analysis .
METHODS	Secondary end points include parasite clearance time , rates of recurrent infection/treatment failure to day 42 , gametocyte carriage throughout follow-up and rates of anaemia at day 28 , as determined by survival analysis .
BACKGROUND	This study has been approved by relevant institutional ethics committees in Malaysia and Australia .
BACKGROUND	Results will be disseminated to inform knowlesi malaria treatment policy in this region through peer-reviewed publications and academic presentations .
BACKGROUND	NCT01708876 .

###25205142
OBJECTIVE	To assess the efficacy/safety of canagliflozin , a sodium-glucose cotransporter 2 inhibitor , compared with glimepiride over 104 weeks in patients with type 2 diabetes inadequately controlled with metformin .
METHODS	In this randomized , double-blind study , patients ( N = 1,450 ) received canagliflozin 100 or 300 mg or glimepiride ( titrated up to 6 or 8 mg/day ) during a 52-week core period followed by a 52-week extension .
RESULTS	At week 104 , reductions from baseline in A1C were -0.65 % , -0.74 % , and -0.55 % ( -7.1 , -8.1 , and -6.0 mmol/mol ) with canagliflozin 100 and 300 mg and glimepiride , respectively .
RESULTS	Durability analyses showed sustained A1C lowering with both canagliflozin doses versus glimepiride .
RESULTS	Reductions in body weight ( -4.1 % , -4.2 % , and 0.9 % , respectively ) and systolic blood pressure ( -2.0 , -3.1 , and 1.7 mmHg , respectively ) were seen with canagliflozin 100 and 300 mg compared with glimepiride at week 104 .
RESULTS	The overall adverse event ( AE ) incidence was 73.3 % , 77.9 % , and 78.4 % with canagliflozin 100 and 300 mg and glimepiride ; the incidence of AE-related discontinuations was low across groups ( 6.2 % , 9.5 % , and 7.3 % , respectively ) .
RESULTS	Incidences of genital mycotic infections , urinary tract infections , and osmotic diuresis-related AEs were higher with canagliflozin than glimepiride ; these were generally mild to moderate in intensity and led to few discontinuations .
RESULTS	Fewer patients had hypoglycemia episodes with canagliflozin 100 and 300 mg than glimepiride ( 6.8 % , 8.2 % , and 40.9 % ) .
RESULTS	Mild decreases in estimated glomerular filtration rate occurred initially with canagliflozin ; these attenuated over 104 weeks .
CONCLUSIONS	Canagliflozin provided durable glycemic improvements compared with glimepiride and was generally well tolerated in patients with type 2 diabetes receiving background treatment with metformin over 104 weeks .

###26211828
BACKGROUND	Catheter ablation is increasingly used to manage atrial fibrillation , but arrhythmia recurrences are common .
BACKGROUND	Adenosine might identify pulmonary veins at risk of reconnection by unmasking dormant conduction , and thereby guide additional ablation to improve arrhythmia-free survival .
BACKGROUND	We assessed whether adenosine-guided pulmonary vein isolation could prevent arrhythmia recurrence in patients undergoing radiofrequency catheter ablation for paroxysmal atrial fibrillation .
METHODS	We did this randomised trial at 18 hospitals in Australia , Europe , and North America .
METHODS	We enrolled patients aged older than 18 years who had had at least three symptomatic atrial fibrillation episodes in the past 6 months , and for whom treatment with an antiarrhythmic drug failed .
METHODS	After pulmonary vein isolation , intravenous adenosine was administered .
METHODS	If dormant conduction was present , patients were randomly assigned ( 1:1 ) to additional adenosine-guided ablation to abolish dormant conduction or to no further ablation .
METHODS	If no dormant conduction was revealed , randomly selected patients were included in a registry .
METHODS	Patients were masked to treatment allocation and outcomes were assessed by a masked adjudicating committee .
METHODS	Patients were followed up for 1 year .
METHODS	The primary outcome was time to symptomatic atrial tachyarrhythmia after a single procedure in the intention-to-treat population .
METHODS	The trial is registered with ClinicalTrials.gov , number NCT01058980 .
RESULTS	Adenosine unmasked dormant pulmonary vein conduction in 284 ( 53 % ) of 534 patients .
RESULTS	102 ( 694 % ) of 147 patients with additional adenosine-guided ablation were free from symptomatic atrial tachyarrhythmia compared with 58 ( 423 % ) of 137 patients with no further ablation , corresponding to an absolute risk reduction of 271 % ( 95 % CI 159-382 ; p < 00001 ) and a hazard ratio of 044 ( 95 % CI 031-064 ; p < 00001 ) .
RESULTS	Of 115 patients without dormant pulmonary vein conduction , 64 ( 557 % ) remained free from symptomatic atrial tachyarrhythmia ( p = 00191 vs dormant conduction with no further ablation ) .
RESULTS	Occurrences of serious adverse events were similar in each group .
RESULTS	One death ( massive stroke ) was deemed probably related to ablation in a patient included in the registry .
CONCLUSIONS	Adenosine testing to identify and target dormant pulmonary vein conduction during catheter ablation of atrial fibrillation is a safe and highly effective strategy to improve arrhythmia-free survival in patients with paroxysmal atrial fibrillation .
CONCLUSIONS	This approach should be considered for incorporation into routine clinical practice .
BACKGROUND	Canadian Institutes of Health Research , St Jude Medical , Biosense-Webster , and M Lachapelle ( Montreal Heart Institute Foundation ) .

###24379136
OBJECTIVE	Chronic Hepatitis C ( CHC ) Virus infection is a serious health issue in the US .
OBJECTIVE	Standard treatment involves peginterferon alpha and ribavirin , often associated with adverse side effects including flu-like symptoms .
OBJECTIVE	These adverse effects are common reasons for the discontinuation of treatment and therefore represent a major obstacle in the effective treatment of CHC .
METHODS	The Hepatitis Physical Symptom Severity Diary , a newly developed patient-reported outcome measure for assessing physical symptoms in CHC patients , was recently developed .
METHODS	It contains four questions addressing flu-like symptoms [ the Flu-Like Symptom Index ( FLSI ) ] .
METHODS	Measurement properties of the FLSI in CHC patients were assessed using data from two randomized clinical trials .
RESULTS	Exploratory factor analysis using data from baseline and the last visit while on treatment supported a single-factor solution for the FLSI .
RESULTS	Internal reliability and test-retest reliability are acceptable ( Cronbach 's alpha range 0.73-0 .81 ; intraclass correlation coefficient range 0.85-0 .97 ) , and correspondence to several similar constructs was acceptable .
RESULTS	The FLSI score was higher among those with investigator-reported flu-like symptoms ( mean = 4.1 ) versus those without ( 1.4 ) , although not statistically significant ( p = 0.12 ) .
RESULTS	Responsiveness of the FLSI was moderate , as measured by standardized effect sizes and response means , and the minimum important difference ( MID ) was estimated at 2.5-3 .0 points .
CONCLUSIONS	While additional research should be conducted to evaluate validity with more closely related constructs and to utilize anchor-based methods for estimating the MID , data suggest that the FLSI has acceptable measurement properties and can be an effective tool in assessing flu-like symptoms in CHC patients .

###25478757
BACKGROUND	Because of its location in the lower neck and anatomical variability , the C7 medial branch represents a challenging target for local anesthetic blocks .
BACKGROUND	Although ultrasound ( US ) guidance offers an alternative to fluoroscopy for C3 to C6 cervical medial branch blocks ( CMBBs ) , its use at the C7 level has not been examined .
BACKGROUND	We hypothesized that US , using a biplanar imaging technique , could provide a shorter performance time than conventional fluoroscopy for C7 CMBB .
METHODS	Fifty patients undergoing C7 CMBB were randomized to fluoroscopy or US guidance .
METHODS	A 0.6-mL mixture of local anesthetic and radiographic contrast was injected in both groups .
METHODS	The primary outcome was performance time .
METHODS	Secondary outcomes included success rate , pain levels preblock and postblock , and incidences of aberrant spread and procedure-related complications .
RESULTS	Compared to fluoroscopy , US guidance was associated with a shorter performance time ( 233.6 80.4 vs 390.6 142.4 seconds ; P < 0.001 ) and fewer needle passes ( 2 vs 4 ; P < 0.001 ) .
RESULTS	However , both imaging modalities provided similar success rates ( 92 % -96 % ) .
RESULTS	Furthermore , no intergroup differences were found in preblock and postblock pain scores .
RESULTS	In the fluoroscopy group , intravascular and intra-articular spreads were seen in 20 % and 4 % of cases , respectively .
RESULTS	In the US group , a blood vessel was visualized overlying the target area and successfully avoided during needle insertion in 40 % of patients .
RESULTS	No procedure-related complications occurred in either group .
CONCLUSIONS	Ultrasound guidance using a biplanar approach provides a similar success rate to fluoroscopy for C7 CMBB .
CONCLUSIONS	However , US is associated with improved efficiency ( decreased performance time and fewer needle passes ) .

###24618349
BACKGROUND	An increase in physical activity for secondary prevention of cardiovascular disease and cardiac rehabilitation has multiple therapeutic benefits , including decreased mortality .
BACKGROUND	Internet - and mobile-based interventions for physical activity have shown promising results in helping users increase or maintain their level of physical activity in general and specifically in secondary prevention of cardiovascular diseases and cardiac rehabilitation .
BACKGROUND	One component related to the efficacy of these interventions is tailoring of the content to the individual .
OBJECTIVE	Our trial assessed the effect of a longitudinally tailored Internet - and mobile-based intervention for physical activity as an extension of a face-to-face cardiac rehabilitation stay .
OBJECTIVE	We hypothesized that users of the tailored intervention would maintain their physical activity level better than users of the nontailored version .
METHODS	The study population included adult participants of a cardiac rehabilitation program in Norway with home Internet access and a mobile phone .
METHODS	The participants were randomized in monthly clusters to a tailored or nontailored ( control ) intervention group .
METHODS	All participants had access to a website with information regarding cardiac rehabilitation , an online discussion forum , and an online activity calendar .
METHODS	Those using the tailored intervention received tailored content based on models of health behavior via the website and mobile fully automated text messages .
METHODS	The main outcome was self-reported level of physical activity , which was obtained using an online international physical activity questionnaire at baseline , at discharge , and at 1 month and 3 months after discharge from the cardiac rehabilitation program .
RESULTS	Included in the study were 69 participants .
RESULTS	One month after discharge , the tailored intervention group ( n = 10 ) had a higher median level of overall physical activity ( median 2737.5 , IQR 4200.2 ) than the control group ( n = 14 , median 1650.0 , IQR 2443.5 ) , but the difference was not significant ( Kolmogorov-Smirnov Z = 0.823 , P = .38 , r = .17 ) .
RESULTS	At 3 months after discharge , the tailored intervention group ( n = 7 ) had a significantly higher median level of overall physical activity ( median 5613.0 , IQR 2828.0 ) than the control group ( n = 12 , median 1356.0 , IQR 2937.0 ; Kolmogorov-Smirnov Z = 1.397 , P = .02 , r = .33 ) .
RESULTS	The median adherence was 45.0 ( 95 % CI 0.0-169 .8 ) days for the tailored group and 111.0 ( 95 % CI 45.1-176 .9 ) days for the control group ; however , the difference was not significant ( P = .39 ) .
RESULTS	There were no statistically significant differences between the 2 groups in stage of change , self-efficacy , social support , perceived tailoring , anxiety , or depression .
CONCLUSIONS	Because of the small sample size and the high attrition rate at the follow-up visits , we can not make conclusions regarding the efficacy of our approach , but the results indicate that the tailored version of the intervention may have contributed to the long-term higher physical activity maintained after cardiac rehabilitation by participants receiving the tailored intervention compared with those receiving the nontailored intervention .
BACKGROUND	ClinicalTrials.gov : NCT01223170 ; http://clinicaltrials.gov/show/NCT01223170 ( Archived by WebCite at http://www.webcitation.org/6Nch4ldcL ) .

###25934864
BACKGROUND	Prospective cohort studies showed inverse associations between the intake of flavonoid-rich foods ( cocoa and tea ) and cardiovascular disease ( CVD ) .
BACKGROUND	Intervention studies showed protective effects on intermediate markers of CVD .
BACKGROUND	This may be due to the protective effects of the flavonoids epicatechin ( in cocoa and tea ) and quercetin ( in tea ) .
OBJECTIVE	We investigated the effects of supplementation of pure epicatechin and quercetin on vascular function and cardiometabolic health .
METHODS	Thirty-seven apparently healthy men and women aged 40-80 y with a systolic blood pressure ( BP ) between 125 and 160 mm Hg at screening were enrolled in a randomized , double-blind , placebo-controlled , crossover trial .
METHODS	CVD risk factors were measured before and after 4 wk of daily flavonoid supplementation .
METHODS	Participants received ( - ) - epicatechin ( 100 mg/d ) , quercetin-3-glucoside ( 160 mg/d ) , or placebo capsules for 4 wk in random order .
METHODS	The primary outcome was the change in flow-mediated dilation from pre - to postintervention .
METHODS	Secondary outcomes included other markers of CVD risk and vascular function .
RESULTS	Epicatechin supplementation did not change flow-mediated dilation significantly ( 1.1 % absolute ; 95 % CI : -0.1 % , 2.3 % ; P = 0.07 ) .
RESULTS	Epicatechin supplementation improved fasting plasma insulin ( insulin : -1.46 mU/L ; 95 % CI : -2.74 , -0.18 mU/L ; P = 0.03 ) and insulin resistance ( homeostasis model assessment of insulin resistance : -0.38 ; 95 % CI : -0.74 , -0.01 ; P = 0.04 ) and had no effect on fasting plasma glucose .
RESULTS	Epicatechin did not change BP ( office BP and 24-h ambulatory BP ) , arterial stiffness , nitric oxide , endothelin 1 , or blood lipid profile .
RESULTS	Quercetin-3-glucoside supplementation had no effect on flow-mediated dilation , insulin resistance , or other CVD risk factors .
CONCLUSIONS	Our results suggest that epicatechin may in part contribute to the cardioprotective effects of cocoa and tea by improving insulin resistance .
CONCLUSIONS	It is unlikely that quercetin plays an important role in the cardioprotective effects of tea .
CONCLUSIONS	This study was registered at clinicaltrials.gov as NCT01691404 .

###24231759
OBJECTIVE	Recent evidence shows poor retention of Pediatric Advanced Life Support provider skills .
OBJECTIVE	Frequent refresher training and in situ simulation are promising interventions .
OBJECTIVE	We developed a `` Pediatric Advanced Life Support-reconstructed '' recertification course by deconstructing the training into six 30-minute in situ simulation scenario sessions delivered over 6 months .
OBJECTIVE	We hypothesized that in situ Pediatric Advanced Life Support-reconstructed implementation is feasible and as effective as standard Pediatric Advanced Life Support recertification .
METHODS	A prospective randomized , single-blinded trial .
METHODS	Single-center , large , tertiary PICU in a university-affiliated children 's hospital .
METHODS	Nurses and respiratory therapists in PICU .
METHODS	Simulation-based modular Pediatric Advanced Life Support recertification training .
RESULTS	Simulation-based pre - and postassessment sessions were conducted to evaluate participants ' performance .
RESULTS	Video-recorded sessions were rated by trained raters blinded to allocation .
RESULTS	The primary outcome was skill performance measured by a validated Clinical Performance Tool , and secondary outcome was behavioral performance measured by a Behavioral Assessment Tool .
RESULTS	A mixed-effect model was used to account for baseline differences .
RESULTS	Forty participants were prospectively randomized to Pediatric Advanced Life Support reconstructed versus standard Pediatric Advanced Life Support with no significant difference in demographics .
RESULTS	Clinical Performance Tool score was similar at baseline in both groups and improved after Pediatric Advanced Life Support reconstructed ( pre , 16.3 4.1 vs post , 22.4 3.9 ; p < 0.001 ) , but not after standard Pediatric Advanced Life Support ( pre , 14.3 4.7 vs post , 14.9 4.4 ; p = 0.59 ) .
RESULTS	Improvement of Clinical Performance Tool was significantly higher in Pediatric Advanced Life Support reconstructed compared with standard Pediatric Advanced Life Support ( p = 0.006 ) .
RESULTS	Behavioral Assessment Tool improved in both groups : Pediatric Advanced Life Support reconstructed ( pre , 33.3 4.5 vs post , 35.9 5.0 ; p = 0.008 ) and standard Pediatric Advanced Life Support ( pre , 30.5 4.7 vs post , 33.6 4.9 ; p = 0.02 ) , with no significant difference of improvement between both groups ( p = 0.49 ) .
CONCLUSIONS	For PICU-based nurses and respiratory therapists , simulation-based `` Pediatric Advanced Life Support-reconstructed '' in situ training is feasible and more effective than standard Pediatric Advanced Life Support recertification training for skill performance .
CONCLUSIONS	Both Pediatric Advanced Life Support recertification training courses improved behavioral performance .

###25760565
BACKGROUND	The safety and efficacy of tenofovir disoproxil fumarate ( TDF ) in HIV-1-infected children have not been evaluated in a randomized controlled trial .
METHODS	Subjects ( 2 to < 16 years ) on a stavudine ( d4T ) or zidovudine ( ZDV ) containing regimen with HIV-1 RNA < 400 copies/mL were randomized to either switch d4T or ZDV to TDF or continue d4T or ZDV .
METHODS	The primary endpoint was the proportion of subjects with HIV-1 RNA < 400 copies/mL at Week 48 with a prespecified noninferiority margin of 15 % .
METHODS	After the 48-week randomized phase , eligible subjects were rolled over to an extension phase .
RESULTS	Ninety-seven children ( 48 TDF vs. 49 d4T or ZDV ) were randomized and treated .
RESULTS	The percent of subjects who maintained virologic suppression in the TDF versus d4T or ZDV group at Week 24 were 93.8 % versus 89.8 % ( difference 4.0 % ; 95 % confidence interval : : -6.9 % to 14.9 % ) and at Week 48 were 83.3 % versus 91.8 % ( difference : -8.5 % ; 95 % confidence interval : -21.5 % to 4.5 % ; missing = failure , intent-to-treat analysis ) .
RESULTS	No subjects discontinued study drug because of an adverse event in the 48 weeks of randomized phase .
RESULTS	Four subjects discontinued TDF because of proximal renal tubulopathy in the extension phase .
CONCLUSIONS	Our study did not demonstrate noninferiority of TDF versus d4T or ZDV at Week 48 .
CONCLUSIONS	Overall safety and tolerability of TDF in children were consistent with adults .
CONCLUSIONS	TDF may be considered as an alternative to d4T or ZDV in HIV-infected children .

###24899339
BACKGROUND	A recent study of supermarket bakery workers in South Africa demonstrated that 25 % of workers were sensitised to flour allergens and 13 % had baker 's asthma .
BACKGROUND	Evidence on exposure reduction strategies using specifically designed interventions aimed at reducing the risk of baker 's asthma is scarce .
OBJECTIVE	The aim of this study was to evaluate the effectiveness of different control measures to reduce airborne flour dust exposure using a randomised design .
METHODS	A group-randomised study design was used to assign 30 bakeries of a large supermarket chain store to two intervention groups and a control group , of which 15 bakeries were studied .
METHODS	Full-shift environmental personal samples were used to characterise exposure to flour dust and wheat and rye allergens levels pre-intervention ( n = 176 ) and post-intervention ( n = 208 ) .
RESULTS	The overall intervention effect revealed a 50 % decrease in mean flour dust , wheat and rye allergen exposure .
RESULTS	The reduction in exposure was highest for managers ( 67 % ) and bakers ( 47 % ) , and lowest for counterhands ( 23 % ) .
RESULTS	For bakers , the greatest reduction in flour dust was associated with control measures such as the use of the mixer lid ( 67 % ) , divider oil ( 63 % ) or focused training ( 54 % ) .
RESULTS	However , the greatest reduction ( 80 % ) was observed when using a combination of all control measures .
CONCLUSIONS	A specially designed intervention strategy reduced both flour dust and allergen levels .
CONCLUSIONS	Best results were observed when combining both engineering controls and training .
CONCLUSIONS	Further studies will investigate the long-term health impact of these interventions on reducing the disease burden among this group of bakers .

###25375836
OBJECTIVE	Depression is common after acute coronary syndrome ( ACS ) and has adverse effects on prognosis .
OBJECTIVE	There are few evidence-based interventions for treating depression in ACS .
OBJECTIVE	This study investigated the efficacy and safety of escitalopram in treating depressive disorders identified 2-14 weeks after a confirmed ACS episode .
METHODS	A total of 217 patients with DSM-IV depressive disorders ( 121 major and 96 minor ) and ACS were randomly assigned to receive escitalopram in flexible doses of 5-20 mg/d ( n = 108 ) or placebo ( n = 109 ) for 24 weeks .
METHODS	The study was conducted from 2007 to 2013 .
METHODS	The primary outcome measure was the Hamilton Depression Rating Scale ( HDRS ) .
METHODS	Secondary outcome measures included the Montgomery-Asberg Depression Rating Scale ( MADRS ) , Beck Depression Inventory ( BDI ) , Clinical Global Impressions-Severity of Illness scale ( CGI-S ) , Social and Occupational Functioning Assessment Scale ( SOFAS ) , and World Health Organization Disability Assessment Schedule-12 .
METHODS	Cardiovascular safety outcomes included echocardiography , electrocardiography , laboratory test , body weight , and blood pressure results .
RESULTS	Escitalopram was superior to placebo in reducing HDRS scores ( mean difference = 2.3 , P = .016 , effect size = 0.38 ) .
RESULTS	Escitalopram was also superior to placebo in decreasing depressive symptoms evaluated by the MADRS , BDI , and CGI-S and in improving SOFAS functioning level .
RESULTS	Escitalopram was not associated with any harmful changes in cardiovascular safety measures .
RESULTS	Dizziness was significantly more frequently reported in the escitalopram group ( P = .018 ) , but there were no significant differences in any other adverse events .
CONCLUSIONS	These results indicate that escitalopram has clinically meaningful antidepressant effects with no evidence of reduced cardiovascular safety in depressive disorder following ACS .
BACKGROUND	ClinicalTrials.gov identifier : NCT00419471 .

###24943245
OBJECTIVE	In ablation of atrial fibrillation , the single-ring method aims for isolation of the posterior wall of the left atrium ( LA ) including the pulmonary veins ( PVs ) but avoiding posterior LA lesions .
OBJECTIVE	The aim of this randomized prospective study was to evaluate safety and efficacy of remote magnetic navigation ( RMN ) - guided single-ring ablation strategy as compared to standard RMN-guided circumferential PV ablation ( PVA ) .
METHODS	Eighty consecutive patients undergoing PVA were enrolled prospectively and randomized equally into two study groups .
METHODS	RMN using the Stereotaxis system and open-irrigated 3.5-mm ablation catheters were used with a 3D mapping system in all procedures .
METHODS	Forty patients underwent RMN-guided single-ring ablation , and 40 patients received RMN-guided circumferential PVA .
RESULTS	In the circumferential group , 3.3 1.1 PVs were successfully isolated at the end of the procedure as compared to 3.1 1.3 in the single-ring ( box ) group ( p = 0.38 ) .
RESULTS	All patients in the box group required additional posterior lesions in order to achieve electrical isolation of the PVs .
RESULTS	Single-ring ablation was associated with longer procedure duration ( p = 0.01 ) and ablation time ( p = 0.001 ) .
RESULTS	After a single procedure , the proportion of patients free of any atrial tachycardia ( AT ) / atrial fibrillation ( AF ) episode at 12-month follow-up was 57 % in the box group and 58 % in the circ group .
RESULTS	Using RMN , only minor complications have been observed .
CONCLUSIONS	RMN-guided single-ring PVA provides comparable acute and long-term success rates as compared to RMN-guided circumferential PVA but requires additional posterior lesions to achieve PV isolation and increased procedure and ablation time .
CONCLUSIONS	Procedural complication rates are low when using RMN .

###24738319
OBJECTIVE	This study investigated the effects and Numerical Rating Pain Scale ( NRS ) of using absorbable shanching satin rb-bFGF prepreg sheet and expansion hemostatic sponge together nasal packing in the control of epistaxis with blood disease , and compared it with traditional vaseline gauze .
METHODS	Ninety-six blood disease patient with epistaxis were enrolled between January 2009 and February 2011 , they were divided into two groups at random , and differently treated with absorbable shanching satin rb-bFGF prepreg sheet and the vaseline gauze nasal packing for haemostasis .
METHODS	Then haemostasis efficacy , the hemorrhage rate after nasal packing removed and host response , such as nasal pain and headache , which evaluated pain degrees against NRS , were all observed .
RESULTS	There was no significant difference between the two groups of the haemostatic effect .
RESULTS	But the hemorrhage rate of treatment group was obviously lower than that of the control group after paching , in addition , host responses , such as nasal pain and headache , remarkably better than the control group , the difference had statistical significance .
CONCLUSIONS	It is indicate that absorbable shanching satin rb-bFGF prepreg sheet presents reliable hemostasis effect , good biocompatibility and compliance ; the pain and headache caused by packing are superior to vaseline gauze .
CONCLUSIONS	Moreover , this method avoids the direct touch of vaseline gauze with nasal mucosal wound , and reduce hemorrhage after packing .
CONCLUSIONS	Absorbable shanching satin rb-bFGF prepreg sheet and expansion hemostatic sponge together is better to select the nasal packing material for blood disease patient with epistaxis .

###24815910
OBJECTIVE	The purpose of this study was to assess long-term improvement in quality of life ( QOL ) in adolescents with attention-deficit/hyperactivity disorder ( ADHD ) treated with lisdexamfetamine dimesylate ( LDX ) .
METHODS	Adolescents with ADHD treated for 3 weeks in a 4 week , placebo-controlled study entered a 1 year , open-label study .
METHODS	After the 4 week dose optimization ( 30 , 50 , and 70mg/day LDX ) period , treatment was maintained for 48 additional weeks .
METHODS	Change from baseline ( of prior study ) to week 52/early termination ( ET ) ( of open-label study ) in ADHD Rating Scale IV ( ADHD-RS-IV ) assessed effectiveness , and the Youth QOL-Research Version ( YQOL-R ) assessed participant-perceived QOL .
METHODS	Post-hoc analyses described effectiveness and QOL for participants with self-perceived poor QOL at baseline ( 1 SD below the mean ) versus all others , and for study completers versus study noncompleters .
RESULTS	These post-hoc analyses included 265 participants .
RESULTS	Participants with baseline self-perceived poor QOL ( n = 32 ) versus all others ( n = 232 ) exhibited robust YQOL-R perceptual score changes ( improvement ) with LDX , emerging by week 28 and maintained to week 52/ET .
RESULTS	Week 52/ET mean change score ranged from +9.8 to +17.6 for participants with baseline self-perceived poor QOL and +0.4 to +5.1 for all others ; week 52/ET improvements in ADHD-RS-IV total scores were similar , regardless of baseline YQOL-R total score .
RESULTS	At week 52/ET , study completers had greater YQOL-R improvements than did noncompleters ; ADHD-RS-IV total score changes were also numerically larger at week 52/ET for completers than for noncompleters .
CONCLUSIONS	Participant-perceived QOL and ADHD symptoms improved from baseline with LDX in adolescents with ADHD ; greatest improvements occurred among participants with baseline self-perceived poor QOL .

###25245776
OBJECTIVE	Chemotherapy-induced peripheral neuropathy ( CIPN ) , a common side effect of chemotherapy , needs better effective treatments .
OBJECTIVE	Preliminary data support the use of Scrambler therapy , a device which treats pain via noninvasive cutaneous electrostimulation , for the treatment of CIPN .
OBJECTIVE	The current manuscript reports data from a pilot trial , performed to investigate the effect of Scrambler therapy for the treatment of established CIPN .
METHODS	Eligible patients had CIPN symptoms of 1 month duration with tingling and/or pain 4/10 during the prior week .
METHODS	Patients were treated with Scrambler therapy to the affected area ( s ) for up to ten daily 30-min sessions .
METHODS	Symptoms were monitored using a neuropathy questionnaire consisting of numerical analog scales ranging from 0 to 10 , daily before therapy as well as weekly for 10 weeks after therapy .
METHODS	Descriptive summary statistics formed the basis of data analysis .
RESULTS	Thirty-seven patients were enrolled .
RESULTS	Twenty-five patients were treated primarily on their lower extremities while 12 were treated primarily on their upper extremities .
RESULTS	There was a 53 % reduction in pain score from baseline to day 10 ; a 44 % reduction in tingling ; and a 37 % reduction in numbness .
RESULTS	Benefit appeared to last throughout 10 weeks of follow-up .
RESULTS	There were no substantial adverse events .
CONCLUSIONS	Preliminary data support that Scrambler therapy may be effective for the treatment of CIPN : a prospective placebo-controlled clinical trial should be performed .

###26307877
BACKGROUND	The treatment of burn patients who undergo mechanical ventilation is complicated by many factors ; patient outcomes and mortality could potentially be improved with predictive biomarkers .
BACKGROUND	Severe burn provokes a systemic inflammatory response characterized by the release of a host of cytokines .
BACKGROUND	Recent studies evaluated the prognostic value of temporal changes in cytokine levels in several patient populations , but few have compared differences in the cytokine profiles of survivors and nonsurvivors following severe burn .
BACKGROUND	We previously compared high-frequency percussive ventilation and low-tidal-volume ventilation and found no difference in mortality or cytokine levels between the two treatments .
BACKGROUND	Since it is unknown whether cytokine levels are predictive of mortality in these patients , we performed a post hoc analysis comparing cytokine levels in survivors and nonsurvivors .
METHODS	We evaluated plasma levels of several cytokines ( interleukin 1 [ IL-1 ] , IL-6 , IL-8 , granulocyte-macrophage colony-stimulating factor , and tumor necrosis factor ) for their prognostic biomarker potential related to mortality at 0 , 3 , and 7 days in survivors and nonsurvivors of burns .
RESULTS	While the majority of values for IL-1 , granulocyte-macrophage colony-stimulating factor , and tumor necrosis factor fell below the limit of quantification , univariate analysis demonstrated higher plasma levels of IL-6 and IL-8 in nonsurvivors on Day 7 .
RESULTS	Logistic regression revealed that elevated plasma IL-8 was independently associated with an increased likelihood of the composite end point of death or ventilator-associated pneumonia with odds ratios of 7.9 , 26 , and 7.3 on Days 0 , 3 , and 7 , respectively .
CONCLUSIONS	Early increases in plasma IL-8 are associated with a multifold increase in death or ventilator-associated pneumonia in mechanically ventilated burn patients .
METHODS	Prognostic/epidemiologic study , level IV ; therapeutic study , level IV .

###24447885
OBJECTIVE	The purpose of this report was to examine the course of smoking among pregnant women with concurrent substance use , and to assess the impact of depression on smoking .
METHODS	Data were gathered as part of a randomized controlled trial assessing the efficacy of substance abuse treatment in pregnant women .
METHODS	Women ( n = 176 ) were recruited before 28 completed weeks of pregnancy , and followed until 3months postpartum .
METHODS	Depression was assessed using the Inventory of Depressive Symptomatology and the MINI Neuropsychiatric Interview .
METHODS	Our outcome was the average number of cigarettes smoked per day .
METHODS	Linear mixed effects regression was used to measure differential changes in smoking .
RESULTS	66 % of women smoked in the three months before pregnancy , 42 % of pre-pregnancy smokers achieved abstinence before delivery and 60 % of the baseline cohort smoked postpartum .
RESULTS	Smoking did not differ significantly between depressed and non-depressed groups .
RESULTS	After delivery both groups increased smoking at similar rates .
CONCLUSIONS	Smoking was common among our cohort of pregnant women with a history of substance use .
CONCLUSIONS	Women were able to discontinue or decrease smoking during pregnancy , but were likely to resume or increase smoking postpartum .
CONCLUSIONS	Having clinically significant depressive symptoms or a diagnosis of depression did not have an obvious effect on smoking behaviors .

###24938580
OBJECTIVE	To assess effects of tadalafil vs placebo on prostatic blood flow measured by transrectal ultrasonography in men aged45years with moderate-to-severe benign prostatic hyperplasia-lower urinary tract symptoms .
METHODS	After screening and washout , patients were randomized to placebo ( n = 50 ) or tadalafil 5mg ( n = 47 ) once daily for 8weeks .
METHODS	Transrectal ultrasonography was performed at baseline , 4 , and 8weeks .
METHODS	The primary efficacy measure was the prostate transition zone ( TZ ) resistive index ( RI ) .
METHODS	Secondary efficacy measures were RI in the peripheral zone and bladder neck , color pixel intensity ( CPI ) , and color pixel density ( CPD ) in all 3 regions .
METHODS	Outcomes were assessed using mixed-model repeated-measures analyses .
RESULTS	The overall treatment effect ( tadalafil vs placebo ) for the change from baseline through week 8 in prostate TZ RI was not statistically significant ( least squares mean change : placebo,-0 .01 ; tadalafil , 0.00 ; P = .118 ) , nor was the change from baseline in prostate TZ CPI ( P = .564 ) or CPD ( P = .592 ) .
RESULTS	Results were similar for all flow measures in prostate peripheral zone and bladder neck .
RESULTS	The adverse event profile was consistent with previous studies with no new safety findings .
CONCLUSIONS	Tadalafil for 8weeks in men with BPH-LUTS did not result in detectable decreases in arterial RI or increases in CPI or CPD in the prostate or bladder neck .
CONCLUSIONS	Detection of changes may not be possible because of already low baseline RI , insufficient sensitivity of techniques used , or may have been confounded by methodologic variability across sites .
CONCLUSIONS	Alternatively , other possible mechanisms not assessed in this study may be more prominently involved .

###25146349
OBJECTIVE	Although the repositioning maneuvers are usually very effective in patients with BPPV , some patients still complain residual dizziness .
OBJECTIVE	Danhong injection ( DHI ) , a traditional Chinese medicine , can effectively dilate blood vessels and improve microcirculation , and has been proven to be effective in improving cervical vertigo and posterior circulation ischemic vertigo .
OBJECTIVE	The aim of this study was to evaluate the effects of DHI on residual dizziness after successful repositioning treatment in patients with BPPV .
METHODS	Eighty-six patients with BPPV were randomized into two treatment groups , DHI group and non DHI group .
METHODS	The DHI group received the same repositioning treatment as the non-DHI group , with the addition of DHI therapy .
METHODS	The durations of residual dizziness of DHI group and non-DHI group were compared .
METHODS	In addition , the scores of the dizziness handicap inventory of these two groups were calculated .
RESULTS	The durations of residual dizziness of DHI group were shorter than that of non-DHI group .
RESULTS	There were no significant differences in the scores of dizziness handicap inventory in the first week between these two groups , and there were much significant differences in the second , the fourth , the sixth and eighth weeks .
CONCLUSIONS	The results demonstrate that DHI can significantly improve the residual dizziness after successful repositioning treatment in patients with BPPV .

###24928295
BACKGROUND	Syphilis infection may potentiate transmission of human immunodeficiency virus ( HIV ) .
BACKGROUND	We sought to determine the extent to which HIV acquisition was associated with syphilis infection within an HIV preexposure prophylaxis ( PrEP ) trial and whether emtricitabine/tenofovir ( FTC/TDF ) modified that association .
METHODS	The Preexposure Prophylaxis Initiative ( iPrEx ) study randomly assigned 2499 HIV-seronegative men and transgender women who have sex with men ( MSM ) to receive oral daily FTC/TDF or placebo .
METHODS	Syphilis prevalence at screening and incidence during follow-up were measured .
METHODS	Hazard ratios for the effect of incident syphilis on HIV acquisition were calculated .
METHODS	The effect of FTC/TDF on incident syphilis and HIV acquisition was assessed .
RESULTS	Of 2499 individuals , 360 ( 14.4 % ) had a positive rapid plasma reagin test at screening ; 333 ( 92.5 % ) had a positive confirmatory test , which did not differ between the arms ( FTC/TDF vs placebo , P = .81 ) .
RESULTS	The overall syphilis incidence during the trial was 7.3 cases per 100 person-years .
RESULTS	There was no difference in syphilis incidence between the study arms ( 7.8 cases per 100 person-years for FTC/TDF vs 6.8 cases per 100 person-years for placebo , P = .304 ) .
RESULTS	HIV incidence varied by incident syphilis ( 2.8 cases per 100 person-years for no syphilis vs 8.0 cases per 100 person-years for incident syphilis ) , reflecting a hazard ratio of 2.6 ( 95 % confidence interval , 1.6-4 .4 ; P < .001 ) .
RESULTS	There was no evidence for interaction between randomization to the FTC/TDF arm and incident syphilis on HIV incidence .
CONCLUSIONS	In HIV-seronegative MSM , syphilis infection was associated with HIV acquisition in this PrEP trial ; a syphilis diagnosis should prompt providers to offer PrEP unless otherwise contraindicated .

###25414932
OBJECTIVE	To test the effectiveness and safety of saxagliptin 5 mg/d in patients with type 2 diabetes mellitus ( T2DM ) with and without history of cardiovascular disease ( CVD ) or cardiovascular ( CV ) risk factors .
METHODS	The authors conducted a post hoc analysis of data from 3 randomized studies that compared saxagliptin versus placebo as initial combination therapy with metformin for 24 weeks ( N = 648 ) and versus placebo as an add-on to insulin with and without metformin for 24 weeks ( N = 455 ) , and assessed noninferiority to glipizide as an add-on to metformin for 52 weeks ( N = 858 ) .
METHODS	Efficacy outcomes were the adjusted mean change from baseline in glycated hemoglobin ( HbA1c ) level , fasting plasma glucose concentration , and body weight and the proportion of patients achieving an HbA1c level < 7 % .
METHODS	Pairwise comparisons were performed in subgroups with 1 ) history/no history of CVD , 2 ) 2 versus 0 to 1 CV risk factors , 3 ) hypertension/no hypertension , and 4 ) statin use/no statin use .
METHODS	Adverse events ( AE ) and hypoglycemia were monitored .
RESULTS	In the initial combination therapy study , reductions in HbA1c level from baseline were greater with saxagliptin versus placebo in all subgroups ( difference [ saxagliptin - placebo ] , -0.38 % to -0.67 % ) .
RESULTS	In the add-on to insulin metformin study , differences in adjusted mean change in HbA1c level versus placebo ranged from -0.23 % to -0.58 % across subgroups .
RESULTS	In the noninferiority to glipizide study , adjusted mean changes in HbA1c level were comparable between saxagliptin and glipizide , across subgroups ( difference , 0.08 % -0.21 % ) .
RESULTS	No evidence suggested clinically relevant treatment-by-subgroup interactions in pairwise comparison .
RESULTS	Incidences of 1 AE were comparable across subgroups .
RESULTS	Incidences of confirmed hypoglycemia with saxagliptin were 0 in both metformin add-on studies and 1.2 % to 7.8 % with saxagliptin + insulin metformin .
CONCLUSIONS	In patients with T2DM , saxagliptin 5 mg/d was similarly effective in improving glycemic control , with an AE profile similar to that of placebo , irrespective of CVD history , number of CV risk factors , hypertension , or statin use .
BACKGROUND	www.ClinicalTrials.gov identifiers : NCT00327015 , NCT00575588 , NCT00757588 .

###25348257
BACKGROUND	Cervical incompetence is one of the causes of preterm birth and mid-trimester pregnancy loss .
BACKGROUND	Cervical cerclage is a surgical procedure to treat cervical incompetence .
BACKGROUND	Cervical cerclage reduces the incidence of preterm birth in women at risk of recurrent preterm birth , without a statistically significant reduction in perinatal mortality or neonatal morbidity .
BACKGROUND	Multifilament/braided sutures such as Mersilene tape have been traditionally used for cervical cerclage .
BACKGROUND	Braided sutures , particularly mesh-like non-absorbable sutures , have been associated with an increased risk of infection and , hence , some obstetricians prefer to use monofilament/non-braided sutures .
BACKGROUND	However , these claims are not substantiated by any scientific or clinical evidence.We propose a pilot/feasibility study which will provide the necessary information for planning a definitive trial investigating the clinical effectiveness of monofilament non-braided suture materials in reducing pregnancy loss rate following cervical cerclage compared to the traditional multifilament braided sutures .
METHODS	Women eligible for elective or ultrasound-indicated cerclage at 12 to 21 + 6 weeks of gestation will be randomised to having the procedure using either a monofilament non-braided suture ( Ethilon ) or a Multifilament braided suture ( Mersilene tape ) inserted using a McDonald technique .
METHODS	Consent for participation in the Cerclage outcome by the type of suture ( COTS ) study will be obtained from each eligible participant .
BACKGROUND	COTS is registered with the International Standard Research for Clinical Trials ( ISRCTN17866773 ) .
BACKGROUND	Registered on 27 March 2013 .

###25153575
OBJECTIVE	Our objective was to evaluate effects of levothyroxine ( l-T4 ) supplementation against neurodevelopmental outcomes at 18 months of corrected age in very-low-birth-weight ( VLBW ) infants with hypothyroxinemia but without elevated thyroid-stimulating hormone ( TSH ) concentration .
METHODS	VLBW infants who had plasma TSH concentrations < 10 U/mL and free thyroxine ( FT4 ) concentrations < 0.8 ng/dL between 2 and 4 weeks of age were enrolled .
METHODS	They were randomly assigned to either the Treated ( n = 25 ) or Untreated group ( n = 45 ) .
METHODS	The Treated group received l-T4 at a dose of 5 g/kg/day .
METHODS	We compared growth and neurodevelopmental outcomes at 18 months of corrected age in the two groups .
RESULTS	There were no significant differences in growth , the incidences of developmental delay , cerebral palsy , visual impairment , and hearing impairment in the two groups .
CONCLUSIONS	In such infants , l-T4 supplementation at a dose of 5 g/kg/day did not affect FT4 levels and showed no beneficial effect at 18 months of corrected age .

###25354407
OBJECTIVE	Consultations for forefoot pain are frequent in primary care , but scientific support of treatment options is scarce .
OBJECTIVE	The purpose of this study is to investigate the effect of podiatric treatment vs standardized advice on proper shoe characteristics and fit of shoes by means of an information leaflet for people aged 50 years and older with forefoot pain in primary care .
METHODS	In this randomized controlled trial , 205 participants aged 50 years and older with hindering nontraumatic forefoot pain have been recruited at their general practitioner 's office .
METHODS	Exclusion criteria were treatment of forefoot problem of less than 6 months ' duration before inclusion , rheumatoid arthritis , and diabetic neuropathy or having pain considered not to be musculoskeletal ( eg , warts ) .
METHODS	Participants received shoe advice by means of an information leaflet or podiatric care .
METHODS	Foot pain , foot-related dysfunction , general health , and social participation were assessed by means of questionnaires every 3 months for 1 year .
METHODS	Using multilevel analysis , we analyzed results at the level of ( 1 ) outcome measures , ( 2 ) the individual , and ( 3 ) the general practitioner .
RESULTS	No differences were found between the 2 treatment groups .
RESULTS	Both intervention groups showed an improvement over time in foot pain and foot-related dysfunction .
CONCLUSIONS	This study found that shoe advice provided to patients consulting their general practitioner for forefoot pain and symptom relief resulted in outcomes similar to treatment outcomes in patients consulting a podiatrist .
CONCLUSIONS	Based on these results , primary care physicians should be cautious when referring a patient to a podiatrist ; instead , they should start by providing advice on proper characteristics and fit of shoes .

###24970708
BACKGROUND	The aim of this randomized controlled trial was to investigate the effects of conventional face-to-face group cognitive behavioral therapy ( GCBT ) and an Internet-delivered guided self-help treatment ( Internet-based CBT , ICBT ) on tinnitus distress .
METHODS	A total of 128 adults with at least mild levels of chronic tinnitus distress were randomly assigned to GCBT ( n = 43 ) , ICBT ( n = 41 ) , or a web-based discussion forum ( DF ) that served as a control condition ( n = 44 ) .
METHODS	Standardized self-report measures [ the Tinnitus Handicap Inventory ( THI ) , Mini-Tinnitus Questionnaire ( Mini-TQ ) , Hospital Anxiety and Depression Scale , Insomnia Severity Index and Tinnitus Acceptance Questionnaire ] were completed at the pre - and post-assessments and at the 6-month follow-up .
RESULTS	Repeated-measures ANOVAs revealed significant time group interaction effects on the primary outcomes ( THI and Mini-TQ scores ) in favor of both CBT interventions compared with the DF at post-assessment ( 0.56 g 0.93 ; all p 0.001 ) .
RESULTS	There were no significant differences between GCBT and ICBT ( all p > 0.05 ) and the treatment effects remained stable at the 6-month follow-up .
CONCLUSIONS	This study provides evidence that ICBT might be an equally effective alternative to conventional CBT in the management of chronic tinnitus .
CONCLUSIONS	Despite encouraging results , further research is necessary to determine the actual potential of ICBT as a viable alternative to CBT , and under which circumstances it is effective .

###25618966
OBJECTIVE	To investigate the effect of thorascopic administration.of ginseng polysaccharides ( GPS ) plus dendritic cells ( DC ) on T helper cell type 1/T helper cell type 2 ( Th1/Th2 ) balance in patients with non-small cell lung cancer ( NSCLC ) .
METHODS	A total of 96 NSCLC patients were divided evenly into two groups .
METHODS	The control group was treated with DCs alone and the treatment group was treated with DCs plus GPS .
METHODS	After DCs and GPS were administered thoracoscopically , once a week , 4 times for 30 days , the patients ' quality of life was measured with the Functional Assessment of Cancer Treatment-Lung ( FACT-L ) questionnaire before and after treatment .
METHODS	Serum interferon - ( INF - ) , interleukin-4 ( IL-4 ) , IL-2 and IL-5 were examined before and after treatments .
RESULTS	The level of Th1 cytokines ( INF - , IL-2 ) and the ratio of Th1/Th2 cytokines ( INF - / IL-4 , IL-2 / IL-5 ) increased in both treatment groups , while Th2 cytokines ( IL-4 , IL-5 ) and FACT-L scores decreased ( P < 0.01 ) .
RESULTS	Furthermore , after treatment Th1 cytokines ( INF - , IL-2 ) and the ratio of Th1/Th2 cytokines ( INF - / IL-4 , IL-2 / IL-5 ) were higher in the DCs + GPS group than in the control group ( P < 0.05 ) .
RESULTS	Conversely , FACT-L scores and Th2 cytokines ( IL-4 , IL-5 ) were higher in the control group than in the DCs + GPS group ( P < 0.05 ) .
CONCLUSIONS	The treatment regime of DCs plus GPS had a greater effect on NSCLC patients ' immune function as compared with DCs alone .
CONCLUSIONS	This was evident by increased expression of Th1 cytokines ( INF - , IL-2 ) and the ratio of Th1/Th2 ( INF - / IL-4 , IL-2 / IL-5 ) , as well as by decreased FACT-L scores and the expression of Th2 cytokines ( IL-4 , IL-5 ) .

###25660925
BACKGROUND	Based on results of the PLATO ( Platelet Inhibition and Patient Outcomes ) trial comparing ticagrelor with clopidogrel therapy , the U.S. Food and Drug Administration approved ticagrelor in 2011 for reducing thrombotic cardiovascular events in patients with acute coronary syndrome ( ACS ) with the proviso that it be taken with low-dose aspirin .
OBJECTIVE	This study sought to assess the cost and cost effectiveness of ticagrelor therapy relative to clopidogrel in treating ACS patients from the perspective of the U.S. health care system .
METHODS	We estimated within-trial resource use and costs using U.S. low-dose aspirin patients in PLATO ( n = 547 ) .
METHODS	Quality-adjusted life expectancy was estimated using the total PLATO population ( n = 18,624 ) , combined with baseline risk and long-term survival data from an external ACS patient cohort .
METHODS	Study drugs were valued at current costs .
METHODS	Cost effectiveness was assessed , as was the sensitivity of results to sampling and methodological uncertainties .
RESULTS	One year of ticagrelor therapy , relative to that of generic clopidogrel , cost $ 29,665 / quality-adjusted life-year gained , with 99 % of bootstrap estimates falling under a $ 100,000 willingness-to-pay threshold .
RESULTS	Results were robust to extensive sensitivity analyses , including variations in clopidogrel cost , exclusion of costs in extended years of life , and a recalibrated estimate of survival reflecting a lower underlying mortality risk in the United States .
CONCLUSIONS	For PLATO-eligible ACS patients , a U.S. perspective comparison of the current standard of dual antiplatelet therapy of aspirin with clopidogrel versus aspirin plus ticagrelor showed that the ticagrelor regimen increased life expectancy at an incremental cost well within accepted benchmarks of good value for money .
CONCLUSIONS	( A Comparison of Ticagrelor [ AZD6140 ] and Clopidogrel in Patients With Acute Coronary Syndrome [ PLATO ] ; NCT00391872 ) .

###24627419
BACKGROUND	Mipomersen , an apolipoprotein B synthesis inhibitor , demonstrated significant reductions in low-density lipoprotein ( LDL ) cholesterol , non-high density lipoprotein cholesterol , and apolipoprotein B in 4 phase 3 studies at the FDA-approved subcutaneous dose of 200 mg once weekly .
RESULTS	A short-term phase 1 study in healthy volunteers was conducted to evaluate the relative bioavailability , safety , and tolerability of mipomersen in 2 test dose regimens in reference to the 200 mg weekly dose regimen .
RESULTS	Eighty-four adults were randomized to 1 of 3 cohorts ( 30 mg once daily , 70 mg 3 times weekly , or 200 mg once weekly ) and then mipomersen or placebo ( 3:1 ratio ) for 3 weeks of treatment .
RESULTS	Comparable mipomersen post-distribution phase plasma concentrations were observed across the 3 dose regimens suggesting similar tissue exposure .
RESULTS	Injection site reactions were reported , but did not lead to treatment discontinuation .
RESULTS	The median incidence of these responses per injection was decreased by lowering the dose .
RESULTS	Signals from a diverse panel of systemic inflammation markers were essentially indistinguishable between dose regimens and placebo treatment .
RESULTS	The one exception was a modest transient post-dose elevation of C-reactive protein ( CRP ) in the mipomersen 200 mg weekly group .
RESULTS	This elevation was not associated with an increase in other proinflammatory markers .
CONCLUSIONS	This study demonstrated a similar drug exposure and overall safety profile between the 3 dosing regimens .
CONCLUSIONS	Exploratory assessment of a diverse panel of biomarkers found no indication of a systemic inflammatory response to mipomersen treatment .
CONCLUSIONS	These results support assessment of alternative dose regimens in longer-term studies .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01061814 .

###25402840
OBJECTIVE	There is disagreement regarding the performance of conventional optical microscopy to assess the origin of hematuria .
OBJECTIVE	The aim of this study was to determine the optimal cutoff point for dysmorphic cells in order to detect glomerular hematuria by optical and phase-contrast microscopy .
METHODS	In total , 131 urine samples ( 66 from patients with glomerulopathies and 65 from nephrolithiasis patients ) were evaluated in a blinded fashion .
METHODS	The percentages of doughnut cells and acanthocytes were verified by optical and phase-contrast microscopy .
METHODS	A total of 131 patients were randomly allocated to the derivation ( n = 73 ) and validation ( n = 58 ) groups .
METHODS	Receiver-operating characteristic ( ROC ) curves were plotted to check the discriminatory power of each group and the best cutoff points were determined by the Youden index in the derivation group and subsequently tested in the validation group .
RESULTS	All areas under the ROC curve ( AUCs ) were statistically significant using both methods ( conventional optical and phase-contrast microscopy ) and both groups ( derivation and validation ) .
RESULTS	AUCs did not differ between different glomerulopathies .
RESULTS	The best cutoff point to determine the glomerular origin of hematuria by total dysmorphic cells was 22 % using an optical conventional microscope and 40 % by phase-contrast microscopy .
CONCLUSIONS	We determined the best cutoff points to interpret erythrocyte dysmorphism and demonstrated that it is possible to discriminate the origin of hematuria by evaluating erythrocyte dysmorphism in urinalysis using either an optical or a phase-contrast microscope .

###24277116
BACKGROUND	Many physicians consider platinum-doublet chemotherapy inappropriate for elderly patients , regardless of their medical fitness .
OBJECTIVE	This was a retrospective subgroup analysis of data from a multicenter , randomized , phase III clinical trial evaluating pemetrexed + carboplatin versus docetaxel + carboplatin in elderly chemo-naive patients with advanced , nonsquamous non-small cell lung cancer ( NSCLC ) .
METHODS	Data from elderly patients ( aged 65 years and 70 years ) were evaluated using the same statistical methods as those used in patients aged < 70 years and qualified intent-to-treat ( Q-ITT ) populations .
METHODS	The primary objective of the clinical trial was comparison of pemetrexed + carboplatin with docetaxel + carboplatin in terms of survival without grade 3 or 4 toxicity in chemo-naive NSCLC patients .
RESULTS	The 65 - and 70-year age groups had 68 and 37 patients , respectively .
RESULTS	Among patients aged 65 years , the adjusted hazard ratio ( HR ) for survival without grade 3-4 toxicity ( HR 0.40 , 95 % confidence interval [ CI ] 0.23-0 .70 ) favored pemetrexed + carboplatin ; this was similar to the HRs in patients aged 70 years ( HR 0.43 , 95 % CI 0.20-0 .92 ) , patients aged < 70 years ( HR 0.44 , 95 % CI 0.32-0 .62 ) , and the Q-ITT population ( HR 0.45 , 95 % CI 0.34-0 .61 ) .
RESULTS	The median values for overall survival ( OS ) and progression-free survival ( PFS ) were similar across all age-group subsets and the Q-ITT population .
RESULTS	The HRs for OS and PFS were similar for all age-group subsets , except for the 70-year age group , which favored pemetrexed + carboplatin to a greater extent .
RESULTS	The toxicity profile was similar across age groups , with the exception of diarrhea , mucosal inflammation , and grade 3-4 neutropenia and leukopenia , which were slightly more common in elderly patients in both treatment arms .
RESULTS	Between-arm differences in the toxicity profiles for the 65 - , 70 - and < 70-year age subgroups were similar to those in the Q-ITT population .
RESULTS	There were no on-study deaths or unexpected toxicities .
CONCLUSIONS	The benefits of pemetrexed + carboplatin were maintained , and toxicity was manageable in both elderly subgroups .
CONCLUSIONS	The favorable risk-benefit profile of pemetrexed + carboplatin makes it an appropriate first-line treatment option for elderly patients with advanced nonsquamous NSCLC .

###25877492
BACKGROUND	Fiscal strategies are increasingly considered upstream nutrition promotion measures .
BACKGROUND	However , few trials have investigated the effectiveness or cost effectiveness of pricing manipulations on diet in real-world settings .
OBJECTIVE	We assessed the effects on fruit , vegetable , and beverage purchasing and consumption of a 20 % price-reduction intervention , a tailored skills-based behavior-change intervention , and a combined intervention compared with a control condition .
METHODS	The Supermarket Healthy Eating for Life trial was a randomized controlled trial conducted over 3 mo [ baseline ( time 1 ) to postintervention ( time 2 ) with a 6-mo follow-up ( time 3 ) ] .
METHODS	Female primary household shoppers in Melbourne , Australia , were randomly assigned to a 1 ) skill-building ( n = 160 ) , 2 ) price-reduction ( n = 161 ) , 3 ) combined skill-building and price-reduction ( n = 160 ) , or 4 ) control ( n = 161 ) group .
METHODS	Supermarket transaction data and surveys were used to measure the following study outcomes : fruit , vegetable , and beverage purchases and self-reported fruit and vegetable consumption at each time point .
RESULTS	At 3 mo ( time 2 ) , price reduction-alone participants purchased more total vegetables and frozen vegetables than did controls .
RESULTS	Price reduction-alone and price reduction-plus-skill-building participants purchased more fruit than did controls .
RESULTS	Relative to controls , in the price-reduction group , total vegetable consumption increased by 233 g/wk ( 3.1 servings or 15 % more than at baseline ) , and fruit purchases increased by 364 g/wk ( 2.4 servings ; 35 % more than at baseline ) .
RESULTS	Increases were not maintained 6 mo postintervention ( time 3 ) .
RESULTS	Price reduction-alone participants showed a tendency for a slight increase in fruit consumption at time 2 ( P = 0.09 ) that was maintained at time 3 ( P = 0.014 ) .
RESULTS	No intervention improved purchases of bottled water or low-calorie beverages .
CONCLUSIONS	A 20 % price reduction in fruit and vegetables resulted in increased purchasing per household of 35 % for fruit and 15 % for vegetables over the price-reduction period .
CONCLUSIONS	These findings show that price modifications can directly increase produce purchases .
CONCLUSIONS	The Supermarket Healthy Eating for Life trial was registered at Current Controlled Trials Registration as ISRCTN39432901 .

###24357853
BACKGROUND	C1q/TNF-Related Protein ( CTRP ) family members are novel adipokines that have anti-inflammatory , immunomodulatory , glucose-regulating and vascular effects .
BACKGROUND	However , the metabolic effects of CTRP9 remain unclear in humans .
OBJECTIVE	The aims of this study were to investigate whether serum CTRP9 concentrations are associated with glucose tolerance , metabolic parameters and abdominal fat accumulation .
OBJECTIVE	In addition , the authors investigated whether the aforementioned effects of CTRP9 are independent of serum adiponectin levels .
METHODS	A total of 221 subjects ( 140 men and 81 women ) , 25-72 years of age ( mean age 46.0 years ) , were randomly selected from two different study populations .
METHODS	The normal glucose tolerance group ( n = 120 ) was selected from one study population and the prediabetes/type 2 diabetes group ( n = 101 ) was selected from the other study population .
METHODS	Serum CTRP9 , total adiponectin concentrations and abdominal fat via computed tomography scan were measured in all subjects .
RESULTS	Subjects in the lower serum CTRP9 tertile were older , had metabolically unhealthy profiles and had lower serum total adiponectin levels when compared with subjects in the middle or upper serum CTRP9 tertiles .
RESULTS	In addition , serum CTRP9 concentration were inversely correlated with age , blood pressure , fasting glucose , homeostasis model assessment for insulin resistance , total cholesterol , triglyceride and low-density lipoprotein cholesterol levels ( all P < 0.01 ) and positively correlated with serum total adiponectin levels ( P = 0.03 ) .
RESULTS	In terms of abdominal fat accumulation , serum CTRP9 concentrations were inversely correlated with visceral fat amount ( P < 0.01 ) , but no correlation was observed with subcutaneous fat amount .
RESULTS	Finally , serum CTRP9 was inversely associated with the presence of metabolic syndrome , independent of age , sex , body mass index , smoking status , total cholesterol , visceral fat and serum total adiponectin concentrations ( odds ratio per 1 s.d. 0.47 ; 95 % confidence interval 0.32-0 .70 ; P < 0.01 ) .
CONCLUSIONS	Serum CTRP9 concentrations were positively associated with favorable glucose or metabolic phenotypes and absence of metabolic syndrome , independent of serum total adiponectin concentrations .

###24556825
BACKGROUND	Skeletal muscle impairment is a recognized complication of COPD , predicting mortality in severe disease .
BACKGROUND	Increasing evidence implicates the renin-angiotensin system in control of muscle phenotype .
BACKGROUND	We hypothesized that angiotensin-converting enzyme ( ACE ) inhibition would improve quadriceps function and exercise performance in COPD .
METHODS	This double-blind , randomized placebo-controlled trial investigated the effect of the ACE inhibitor , fosinopril , on quadriceps function in patients with COPD with quadriceps weakness .
METHODS	Primary outcomes were change in quadriceps endurance and atrophy signaling at 3 months .
METHODS	Quadriceps maximum voluntary contraction ( QMVC ) , mid-thigh CT scan of the cross-sectional area ( MTCSA ) , and incremental shuttle walk distance ( ISWD ) were secondary outcomes .
RESULTS	Eighty patients were enrolled ( mean [ SD ] , 65 [ 8 ] years , FEV1 43 % [ 21 % ] predicted , 53 % men ) .
RESULTS	Sixty-seven patients ( 31 fosinopril , 36 placebo ) completed the trial .
RESULTS	The treatment group demonstrated a significant reduction in systolic BP ( -10.5 mm Hg ; 95 % CI , -19.9 to -1.1 ; P = .03 ) and serum ACE activity ( -20.4 IU/L ; 95 % CI , -31.0 to -9.8 ; P < .001 ) compared with placebo .
RESULTS	No significant between-group differences were observed in the primary end points of quadriceps endurance half-time ( 0.5 s ; 95 % CI , -13.3 -14.3 ; P = .94 ) or atrogin-1 messenger RNA expression ( -0.03 arbitrary units ; 95 % CI , -0.32 -0.26 ; P = .84 ) .
RESULTS	QMVC improved in both groups ( fosinopril : 1.1 kg ; 95 % CI , 0.03-2 .2 ; P = .045 vs placebo : 3.6 kg ; 95 % CI , 2.1-5 .0 ; P < .0001 ) with a greater increase in the placebo arm ( between-group , P = .009 ) .
RESULTS	No change was shown in the MTCSA ( P = .09 ) or ISWD ( P = .51 ) .
CONCLUSIONS	This randomized controlled trial found that ACE inhibition , using fosinopril for 3 months , did not improve quadriceps function or exercise performance in patients with COPD with quadriceps weakness .
BACKGROUND	Current Controlled Trials ; No. : ISRCTN05581879 ; URL : www.controlled-trials.com .

###25534294
BACKGROUND	The LUME-Lung 1 trial ( NCT00805194 ; Study 1199.13 ) demonstrated a significant overall survival ( OS ) advantage for nintedanib plus docetaxel compared with placebo plus docetaxel as second-line therapy for patients with advanced non-small cell lung cancer ( NSCLC ) and adenocarcinoma histology .
BACKGROUND	Patient-reported outcomes ( PROs ) for symptoms and health-related quality of life ( QoL ) are reported here .
METHODS	PROs were assessed at screening , on Day 1 of each 21-day treatment cycle , at the end of active treatment , and at the first follow-up visit .
METHODS	PRO instruments were the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and Lung Cancer-13 supplement , and the EuroQol disease-generic questionnaire ( EQ-5D and EQ-VAS ) .
METHODS	Analyses of PRO items for lung cancer-specific symptoms of cough , dyspnoea and pain were prespecified .
RESULTS	Rates of questionnaire completion were high .
RESULTS	There was no significant difference in time to deterioration of global health status/QoL , or symptoms of cough , dyspnoea or pain , between the treatment groups for both the overall study population and the adenocarcinoma population .
RESULTS	Time to deterioration of some gastrointestinal events was shorter with nintedanib versus placebo .
RESULTS	Longitudinal analysis for the adenocarcinoma population showed comparable changes between the groups in symptom scores over time , with numerical differences in favour of nintedanib for cough and pain scales , and significant reductions in some pain items with nintedanib versus placebo .
RESULTS	There was no statistically significant difference in EQ-5D or EQ-VAS between the groups .
CONCLUSIONS	The significant OS benefit observed with the addition of nintedanib to docetaxel therapy was achieved with no detrimental effect on patient self-reported QoL .

###24785885
OBJECTIVE	Kakkonto , a Japanese herbal medicine , is frequently used to treat the common cold not only with a physician 's prescription , but also in self-medication situations .
OBJECTIVE	This study aimed to examine whether Kakkonto prevents the aggravation of cold symptoms if taken at an early stage of illness compared with a well-selected Western-style multiple cold medicine .
METHODS	This study was a multicenter , active drug-controlled , randomized trial .
METHODS	Adults 18 to 65 years of age who felt a touch of cold symptoms and visited 15 outpatient healthcare facilities within 48 hours of symptoms onset were enrolled .
METHODS	The participants were randomly assigned to two groups : one treated with Kakkonto ( Kakkonto Extract-A , 6 g/day ) ( n = 209 ) and one treated with a Western-style multiple cold medicine ( Pabron Gold-A , 3.6 g/day ) ( n = 198 ) for at most four days .
METHODS	The primary outcome of this study was the aggravation of cold , nasal , throat or bronchial symptoms , scored as moderate or severe and lasting for at least two days within five days after entry into the study .
RESULTS	Among the 410 enrollees , 340 ( 168 in the Kakkonto group and 172 in the Pabron group ) were included in the analyses .
RESULTS	The proportion of participants whose colds were aggravated was 22.6 % in the Kakkonto group and 25.0 % in the Pabron group ( p = 0.66 ) .
RESULTS	The overall severity of the cold symptoms was not significantly different between the groups .
RESULTS	No harmful adverse events occurred in either group .
CONCLUSIONS	Kakkonto did not significantly prevent the progression of cold symptoms , even when prescribed at an early stage of the disease .

###24287602
BACKGROUND	Compared with healthy individuals , those with upper respiratory tract illnesses ( URTIs ) report reduced alertness and have slower reaction times .
BACKGROUND	It is important to evaluate medication that can remove this behavioural malaise .
OBJECTIVE	The aim of this study was to compare the effects of a combination of ibuprofen plus caffeine with ibuprofen and caffeine alone , and placebo on malaise associated with URTIs , as measured by psychomotor performance and mood testing .
METHODS	Volunteers were randomly assigned to one of four medication conditions as follows : 200mg ibuprofen and 100mg caffeine ; 200mg ibuprofen ; 100mg caffeine ; placebo .
METHODS	A single oral dose was given and testing followed for 3h .
METHODS	Efficacy variables were based on the volunteers ' performance , measured by psychomotor performance and mood .
RESULTS	The pre-drug results confirmed that those with an URTI had a more negative mood and impaired performance .
RESULTS	Results from the simple reaction time task , at both 55 - and 110-min post-dosing , showed that a single-dose of caffeinated products ( I200/C100 and CAF100 ) led to significantly faster reaction times than IBU200 and placebo .
RESULTS	These effects were generally confirmed with the other performance tasks .
RESULTS	Subjective measures showed that the combination of ibuprofen and caffeine was superior to the other conditions .
RESULTS	There were no serious adverse events reported , and study medication was well tolerated .
CONCLUSIONS	The results from the post-drug assessments suggest that a combination of ibuprofen and caffeine was the optimum treatment for malaise associated with URTIs in that it had significant effects on objective performance and subjective measures .

###25093483
BACKGROUND	Recent studies evaluated the disease-modifying properties of lithium in mild cognitive impairment and dementia .
BACKGROUND	Although potentially effective for these purposes , chronic lithium use in regard to safety in the elderly needs to be better explored .
OBJECTIVE	To evaluate the effect of long-term lithium treatment at subtherapeutic doses on renal function in older adults .
OBJECTIVE	Secondary aims were to evaluate the clinical safety and tolerability of this treatment and its effects on thyroid , immune , and glycemic functions .
METHODS	Between February 2007 and October 2011 , a 2-year randomized , double-blind , placebo-controlled trial followed by a single-blinded phase for an additional 2 years .
METHODS	Sixty-one patients with mild cognitive impairment ( Mayo Clinic criteria ) were randomized to receive lithium or placebo .
METHODS	Renal function was estimated by the abbreviated Modification of Diet in Renal Disease ( aMDRD ) and the Chronic Kidney Disease-Epidemiology study ( CKD-EPI ) equations .
METHODS	Leukocytes , serum thyroid-stimulating hormone ( TSH ) and free thyroxine ( T ) , and serum glucose and insulin were determined .
METHODS	Tolerability was evaluated at 3-month intervals through systematic clinical examinations and by the UKU Side Effect Rating Scale .
RESULTS	Analysis of longitudinal regression indicated that no significant changes in renal function were detected by the aMDRD ( P = .453 ) and CKD-EPI ( P = .213 ) equations after 4 years of lithium treatment .
RESULTS	Significant increases in the number of neutrophils ( P = .038 ) , serum TSH ( P = .034 ) , and body weight ( P = .015 ) were observed in the lithium group .
RESULTS	The lithium group presented more overall adverse events ( P = .045 ) , particularly interfering in daily activities ( P < .001 ) .
RESULTS	In addition , those patients had a higher incidence of diabetes mellitus ( P = .037 ) and arrhythmia ( P = .028 ) .
CONCLUSIONS	Chronic use of lithium at low doses did not affect renal function and was clinically safe .
CONCLUSIONS	However , some other potentially relevant adverse events were observed and others could not be ruled out due to limitations of the study design .
BACKGROUND	ClinicalTrials.gov identifier : NCT01055392 .

###24279904
BACKGROUND	Age-related cognitive decline ( ARCD ) is of major societal concern in an ageing population , with the development of dietary supplements providing a promising avenue for amelioration of associated deficits .
BACKGROUND	Despite initial interest in the use of phospholipids ( PLs ) for ARCD , in recent years there has been a hiatus in such research .
BACKGROUND	Because of safety concerns regarding PLs derived from bovine cortex , and the equivocal efficacy of soybean-derived PLs , there is an important need for the development of new PL alternatives .
BACKGROUND	Phospholipids derived from milk proteins represent one potential candidate treatment .
METHODS	In order to reduce the effects of age-associated memory impairment ( AAMI ) the Phospholipid Intervention for Cognitive Ageing Reversal ( PLICAR ) was developed to test the efficacy of a milk protein concentrate rich in natural , non-synthetic milk phospholipids ( Lacprodan PL-20 ) .
METHODS	PLICAR is a randomized , double-blind , placebo-controlled parallel-groups study where 150 ( N = 50/group ) AAMI participants aged > 55 years will be randomized to receive a daily supplement of Lacprodan PL-20 or one of two placebos ( phospholipid-free milk protein concentrate or inert rice starch ) over a 6-month ( 180-day ) period .
METHODS	Participants will undergo testing at baseline , 90 days and 180 days .
METHODS	The primary outcome is a composite memory score from the Rey Auditory Verbal Learning Test .
METHODS	Secondary outcomes include cognitive ( verbal learning , working memory , prospective and retrospective memory , processing speed and attention ) , mood ( depression , anxiety , stress and visual analogue scales ) , cardiovascular ( blood pressure , blood velocity and pulse wave pressure ) , gastrointestinal microbiota and biochemical measures ( oxidative stress , inflammation , B vitamins and Homocysteine , glucoregulation and serum choline ) .
METHODS	Allelic differences in the Apolipoprotein E and ( APOE ) and Methylenetetrahydrofolate reductase ( MTHFR ) gene will be included for subgroup analysis .
METHODS	A subset ( N = 60 ; 20/group ) ) will undergo neuroimaging using functional magnetic resonance imaging ( fMRI ) and magnetoencephalography ( MEG ) in order to further explore in vivo central mechanisms of action of Lacprodan PL-20 .
METHODS	This study will enable evaluation of the efficacy of milk-derived phospholipids for AAMI , and their mechanisms of action .
BACKGROUND	The trial is jointly funded by Arla Foods and Swinburne University of Technology , currently recruiting and is registered on the Australian New Zealand Clinical Trials Registry as ACTRN12613000347763 .

###26466202
BACKGROUND	The choice of drug-eluting stent in the treatment of patients with diabetes mellitus and coronary artery disease who are undergoing percutaneous coronary intervention ( PCI ) has been debated .
BACKGROUND	Previous studies comparing paclitaxel-eluting stents with stents eluting rapamycin ( now called sirolimus ) or its analogues ( everolimus or zotarolimus ) have produced contradictory results , ranging from equivalence between stent types to superiority of everolimus-eluting stents .
METHODS	We randomly assigned 1830 patients with diabetes mellitus and coronary artery disease who were undergoing PCI to receive either a paclitaxel-eluting stent or an everolimus-eluting stent .
METHODS	We used a noninferiority trial design with a noninferiority margin of 4 percentage points for the upper boundary of the 95 % confidence interval of the risk difference .
METHODS	The primary end point was target-vessel failure , which was defined as a composite of cardiac death , target-vessel myocardial infarction , or ischemia-driven target-vessel revascularization at the 1-year follow-up .
RESULTS	At 1 year , paclitaxel-eluting stents did not meet the criterion for noninferiority to everolimus-eluting stents with respect to the primary end point ( rate of target-vessel failure , 5.6 % vs. 2.9 % ; risk difference , 2.7 percentage points [ 95 % confidence interval , 0.8 to 4.5 ] ; relative risk , 1.89 [ 95 % confidence interval , 1.20 to 2.99 ] ; P = 0.38 for noninferiority ) .
RESULTS	There was a significantly higher 1-year rate in the paclitaxel-eluting stent group than in the everolimus-eluting stent group of target-vessel failure ( P = 0.005 ) , spontaneous myocardial infarction ( 3.2 % vs. 1.2 % , P = 0.004 ) , stent thrombosis ( 2.1 % vs. 0.4 % , P = 0.002 ) , target-vessel revascularization ( 3.4 % vs. 1.2 % , P = 0.002 ) , and target-lesion revascularization ( 3.4 % vs. 1.2 % , P = 0.002 ) .
CONCLUSIONS	In patients with diabetes mellitus and coronary artery disease undergoing PCI , paclitaxel-eluting stents were not shown to be noninferior to everolimus-eluting stents , and they resulted in higher rates of target-vessel failure , myocardial infarction , stent thrombosis , and target-vessel revascularization at 1 year .
CONCLUSIONS	( Funded by Boston Scientific ; TUXEDO-India Clinical Trials Registry-India number , CTRI/2011/06 / 001830 ) .

###24687640
OBJECTIVE	The purpose of this study was to determine whether sleep changes are a consequence of nicotine presence or withdrawal during the night , we examined 66 healthy non-smokers ( 33 males , 33 females , age : 20-25 years ) after an adaptation night in a sleep laboratory setting .
OBJECTIVE	Subjects were randomized to receive placebo or either 8 or 16 mg nicotine patches during the day or during the night in a double blind , parallel group design .
RESULTS	The 16 mg nicotine patch applied during the night caused a reduced sleep period time and sleep efficiency as well as an increased wake time .
RESULTS	A reduced REM-sleep latency and subjective sleep quality rating were found in subjects receiving nicotine during the night .
RESULTS	Arousals , apneas and periodic leg movements were not affected by nicotine .
CONCLUSIONS	This study documents insomnia-like sleep changes in healthy non-smokers caused by nicotine in a dose-dependent manner .
CONCLUSIONS	There was no evidence for sleep-related withdrawal symptoms after 13 h of nicotine application .

###24445356
BACKGROUND	Dysmenorrhea , the occurrence of painful menstrual cramping of the uterus , is a major cause of activity restriction and absences from school and work among young women .
BACKGROUND	Standard pharmaceuticals used to treat dysmenorrhea are not effective for all women and have side effects that limit their use .
BACKGROUND	Studies elsewhere have shown beneficial effects for use of vitamin K1 as an acupoint treatment , but the acceptability of this treatment to women in the United States has been unknown .
OBJECTIVE	The study intended to examine the feasibility , acceptability , and preliminary effects of acupuncture point injection of vitamin K1 as an alternative treatment for primary dysmenorrhea among US women .
METHODS	The research team conducted a pilot study using a blinded , randomized , crossover trial design .
METHODS	The study took place at the University of California , San Francisco ( UCSF ) .
METHODS	The study was conducted in the San Francisco Bay Area among women 18 to 25 y of age who had been diagnosed with primary dysmenorrhea .
METHODS	Fourteen women completed all of the study 's visits .
METHODS	Women with primary dysmenorrhea were randomized into 2 groups to receive bilateral injections of vitamin K1 in the Spleen-6 ( SP-6 ) acupuncture point at the start of menstruation and then , following a 2-mo washout period , saline in a nonacupuncture point at the start of menstruation .
METHODS	One group received the vitamin K1 injection first , while the other group received the saline injection first .
METHODS	Dysmenorrhea pain intensity was measured using a 0-10 numeric rating scale ( NRS ) , before and after injections .
RESULTS	Women had an average 2.5-point decrease in pain after a vitamin K1 injection in the SP-6 acupoint ( P < .001 ) , as compared with a 1.8-point decrease after a saline injection ( P < .001 ) .
RESULTS	Change scores for vitamin K1 , as compared with a saline injection , approached statistical significance ( P < .10 ) .
RESULTS	Intensity and duration of menstrual symptoms , as measured by the Cox retrospective symptom scale , also decreased following injections .
RESULTS	After participating , 94 % of the women remained agreeable to receiving the injection therapy , and 77 % reported they would come every month were the treatment available .
CONCLUSIONS	Findings suggested high acceptability for an acupuncture point injection of vitamin K1 as treatment for primary dysmenorrhea among young women in San Francisco .
CONCLUSIONS	Pain decreased with both treatments , with a trend toward greater pain reduction for the vitamin K1/SP -6 injection .
CONCLUSIONS	This finding is consistent with outcomes from the Obstetrics and Gynecology Hospital in Shanghai , China , where the protocol was developed .

###25684570
BACKGROUND	Current guidelines recommend unfractionated heparin ( UFH ) or low-molecular-weight heparin plus an oral anticoagulant for the prevention of thromboembolism in patients undergoing electric cardioversion of atrial fibrillation ( AF ) .
BACKGROUND	Selective factor Xa inhibitors , such as fondaparinux , which has a favourable benefit-risk profile in the prevention and treatment of venous thromboembolism and the management of acute coronary syndromes , have not been systematically evaluated in this setting .
OBJECTIVE	To evaluate the efficacy and safety of fondaparinux versus standard treatment in patients undergoing echocardiographically-guided cardioversion of AF .
METHODS	In this multicentre , randomized , open-label , controlled , two-parallel-group , phase II pilot study , patients with AF undergoing electric cardioversion following transoesophageal echocardiography ( TEE ) were randomized to fondaparinux or standard therapy ( UFH plus vitamin K antagonist [ VKA ] ) .
METHODS	Patients showing an atrial thrombus in the first TEE ( clot-positive ) were randomized to treatment with fondaparinux or standard care for 4 weeks before cardioversion .
RESULTS	The primary endpoint ( combined rate of cerebral neurological events , systemic thromboembolism , all-cause death and major bleeding events ) occurred in 3 of 174 ( 1.7 % ) patients on fondaparinux and 2 of 170 ( 1.2 % ) patients on UFH+VKA .
RESULTS	The rate of thrombus disappearance among clot-positive patients was higher in the fondaparinux arm ( 11 of 14 ; 78.6 % ) than in the UFH+VKA arm ( 7 of 14 ; 50.0 % ) .
RESULTS	Incidences of adverse events were similar ( 45.4 % with fondaparinux and 46.5 % with UFH+VKA ) .
CONCLUSIONS	In this pilot study in patients with TEE-guided cardioversion , the use of fondaparinux appeared to be well tolerated , with similar efficacy to UFH+VKA .
CONCLUSIONS	Furthermore , a trend to greater thrombus resolution was observed .

###24820759
BACKGROUND	It remains unclear whether concomitant radiofrequency ablation procedure in valvular surgery could offer additional benefits to patients with rheumatic valvular disease .
BACKGROUND	We designed a prospective and randomized control study to evaluate the efficacy of surgical radiofrequency ablation in patients with rheumatic heart disease .
METHODS	From June 2008 to July 2011 , 210 patients with chronic atrial fibrillation and rheumatic heart disease were randomized : ( 1 ) control group , patients underwent only valve replacement followed by amiodarone for rhythm control , ( 2 ) left atrial group ( LA group ) , patients underwent valve replacement and left atrial mono-polar radiofrequency ablation , ( 3 ) bi-atrial group ( BA group ) , patients underwent valve replacement and bi-atrial mono-polar radiofrequency ablation .
METHODS	The primary endpoints included : cardiac death , stroke , and recurrent AF after discharge .
RESULTS	There was no perioperative death .
RESULTS	One patient died 4 months after MVR in BA group .
RESULTS	In univariate Cox analysis , the two ablation groups were associated with less AF ( BA group vs control group : P < 0.001 ; LA group vs control group : P < 0.001 ) as well as atrial tachycardia arrhythmia ( AF/AT/AFL ) recurrent ( BA group vs control group : P < 0.001 ; LA group vs control group : P = 0.02 ) .
RESULTS	The comparison between BA and LA groups revealed no differences in terms of AF ( P = 0.06 ) or AF/AT/AFL ( P = 0.09 ) .
RESULTS	Atrial transport function restoration rate 12 months after operation was 31.4 % in LA group , 32.9 % in BA group , and 8.6 % in control group respectively ( P < 0.01 ) .
CONCLUSIONS	Radiofrequency ablation concurring with valvular surgery can bring a higher sinus rhythm restoration rate when compared with medical anti-arrhythmic drug therapy in low-medium risk rheumatic heart disease .
CONCLUSIONS	The trial was registered on Clinicaltrials.gov ( registry number NCT01013688 ) .

###24320943
OBJECTIVE	This study examined the role of independence centrality ( the personal importance of being functionally independent ) in adapting to functional disability in persons with spinal cord injury ( SCI ) .
OBJECTIVE	We assessed how changes in disability related to changes in depressive symptoms , the association between independence centrality and depressive symptoms , and the role of independence centrality in moderating the association between changes in disability and changes in depressive symptoms .
METHODS	Using data from a randomized controlled trial , we focused on 173 survivors of SCI who completed baseline and 12-month follow-up measures of independence centrality , disability ( activities of daily living and instrumental activities of daily living needs ) , and depressive symptoms .
RESULTS	Consistent with our predictions , increased disability was related to increased depressive symptoms , and higher independence centrality was associated with more depressive symptoms at baseline .
RESULTS	Consistent with the life span theory of control , SCI survivors with high independence centrality experienced more depressive symptoms when disability increased , but less depressive symptoms when disability decreased .
RESULTS	Survivors of SCI with low independence centrality were less affected by changing levels of disability .
CONCLUSIONS	Persons with SCI with high independence centrality have higher levels of depressive symptoms and are more responsive to changes in functional status .
CONCLUSIONS	Given the functional status trajectories of survivors of SCI , having low independence centrality may be adaptive because it facilitates disengagement from unattainable goals .

###25709122
BACKGROUND	Creatinine ( Cr ) has been implicated as an independent predictor of hypertension and exercise has been reported as adjunct therapy for hypertension .
BACKGROUND	The purpose of the present study was to investigate the effect of continuous training programme on blood pressure and serum creatinine concentration in black African subjects with hypertension .
METHODS	Three hundred and fifty seven male patients with mild to moderate ( systolic blood pressure [ SBP ] between 140-180 & diastolic blood pressure [ DBP ] between 90-109 mmHg ) essential hypertension were age matched and randomly grouped into continuous & control groups .
METHODS	The continuous group involved in an 8 weeks continuous training ( 60-79 % HR reserve ) of between 45 minutes to 60 minutes , 3 times per week , while the control group remain sedentary .
METHODS	SBP , DBP , VO2max , serum Cr , body mass index ( BMI ) , waist hip ratio ( WHR ) and percent ( % ) body fat .
METHODS	Analysis of covariance ( ANCOVA ) and Pearson correlation tests were used in data analysis .
RESULTS	Findings of the study revealed significant decreased effects of continuous training programme on SBP , DBP , Cr , BMI , WHR , % body fat and significant increase in VO2max at p < 0.05 .
RESULTS	Serum Cr is significantly and negatively correlated with SBP ( -.335 ) , DBP ( .194 ) , BMI ( .268 ) , WHR ( -.258 ) and % body fat ( -.190 ) at p < 0.05 .
CONCLUSIONS	The present study demonstrated a rationale bases for the adjunct therapeutic role of moderate intensity continuous exercise training as a multi-therapy in the down regulation of blood pressure , serum Cr , body size and body fat in hypertension .

###25064573
BACKGROUND	Exercise is consistently recommended for older adults with knee pain related to osteoarthritis .
BACKGROUND	However , the effects from exercise are typically small and short-term , likely linked to insufficient individualisation of the exercise programme and limited attention to supporting exercise adherence over time .
BACKGROUND	The BEEP randomised trial aims to improve patients ' short and long-term outcomes from exercise .
BACKGROUND	It will test the overall effectiveness and cost-effectiveness of two physiotherapy-led exercise interventions ( Individually Tailored Exercise and Targeted Exercise Adherence ) to improve the individual tailoring of , and adherence to exercise , compared with usual physiotherapy care .
METHODS	Based on the learning from a pilot study ( ISRCTN 23294263 ) , the BEEP trial is a multi-centre , pragmatic , parallel group , individually randomised controlled trial , with embedded longitudinal qualitative interviews .
METHODS	500 adults in primary care , aged 45 years and over with knee pain will be randomised to 1 of 3 treatment groups delivered by fully trained physiotherapists in up to 6 NHS services .
METHODS	These are : Usual Physiotherapy Care ( control group consisting of up to 4 treatment sessions of advice and exercise ) , Individually Tailored Exercise ( an individualised , supervised and progressed lower-limb exercise programme ) or Targeted Exercise Adherence ( supporting patients to adhere to exercise and to engage in general physical activity over the longer-term ) .
METHODS	The primary outcomes are pain and function as measured by the Western Ontario and McMaster Osteoarthritis index .
METHODS	A comprehensive range of secondary outcomes are also included .
METHODS	Outcomes are measured at 3 , 6 ( primary outcome time-point ) , 9 , 18 and 36 months .
METHODS	Data on adverse events will also be collected .
METHODS	Semi-structured , qualitative interviews with a subsample of 30 participants ( 10 from each treatment group ) will be undertaken at two time-points ( end of treatment and 12 to 18 months later ) and analysed thematically .
CONCLUSIONS	This trial will contribute to the evidence base for management of older adults with knee pain attributable to osteoarthritis in primary care .
CONCLUSIONS	The findings will have important implications for healthcare commissioners , general practitioners and physiotherapy service providers and it will inform future education of healthcare practitioners .
CONCLUSIONS	It may also serve to delay or prevent some individuals from becoming surgical candidates .
BACKGROUND	ISRCTN93634563 .

###24725797
OBJECTIVE	To investigate whether Myofascial release ( MFR ) when used as an adjunct to specific back exercises ( SBE ) reduces pain and disability in chronic low back pain ( CLBP ) in comparison with a control group receiving a sham Myofascial release ( SMFR ) and specific back exercises ( SBE ) among nursing professionals .
METHODS	Randomized , controlled , single blinded trial .
METHODS	Nonprofit research foundation clinic in Kerala , India .
METHODS	Nursing professionals ( N = 80 ) with chronic low back pain ( CLBP ) .
METHODS	MFR group or control group .
METHODS	The techniques were administered by physiotherapists certified in MFR and consisted of 24 sessions per client over 8 weeks .
METHODS	The McGill Pain Questionnaire ( MPQ ) was used to assess subjective pain experience and Quebec Back Pain Disability Scale ( QBPDS ) was used to assess the disability associated with CLBP .
METHODS	The primary outcome measure was the difference in MPQ and QBPDS scores between week 1 ( pretest score ) , week 8 ( posttest score ) , and follow-up at week 12 after randomization .
RESULTS	The simple main effects analysis showed that the MFR group performed better than the control group in weeks 8 and 12 ( P < 0.005 ) .
RESULTS	The patients in the MFR group reported a 53.3 % reduction in their pain and 29.7 % reduction in functional disability as shown in the MPQ and QBPDS scores in week 8 , whereas patients in the control group reported a 26.1 % and 9.8 % reduction in their MPQ and QBPDS scores in week 8 , which persisted as a 43.6 % reduction of pain and 22.7 % reduction of functional disability in the follow-up at week 12 in the MFR group compared to the baseline .
RESULTS	The proportion of responders , defined as participants who had at least a 50 % reduction in pain between weeks 1 and 8 , was 73 % in the MFR group and 0 % in the control group , which was 0 % for functional disability in the MFR and control group .
CONCLUSIONS	This study provides evidence that MFR when used as an adjunct to SBE is more effective than a control intervention for CLBP in nursing professionals .

###24939916
BACKGROUND	Persons with a mental disorder smoke at higher rates and suffer disproportionate tobacco-related burden compared with the general population .
BACKGROUND	The aim of this study was to determine if a smoking cessation intervention initiated during a psychiatric hospitalization and continued postdischarge was effective in reducing smoking behaviors among persons with a mental disorder .
METHODS	A randomized controlled trial was conducted at an Australian inpatient psychiatric facility .
METHODS	Participants were 205 patient smokers allocated to a treatment as usual control ( n = 101 ) or a smoking cessation intervention ( n = 104 ) incorporating psychosocial and pharmacological support for 4 months postdischarge .
METHODS	Follow-up assessments were conducted at 1 week , 2 , 4 , and 6 months postdischarge and included abstinence from cigarettes , quit attempts , daily cigarette consumption , and nicotine dependence .
RESULTS	Rates of continuous and 7-day point prevalence abstinence did not differ between treatment conditions at the 6-month follow-up ; however , point prevalence abstinence was significantly higher for intervention ( 11.5 % ) compared with control ( 2 % ) participants at 4 months ( OR = 6.46 , p = .01 ) .
RESULTS	Participants in the intervention condition reported significantly more quit attempts ( F [ 1 , 202.5 ] = 15.23 , p = .0001 ) , lower daily cigarette consumption ( F [ 4 , 586 ] = 6.5 , p < .001 ) , and lower levels of nicotine dependence ( F [ 3 , 406 ] = 8.5 , p < .0001 ) compared with controls at all follow-up assessments .
CONCLUSIONS	Postdischarge cessation support was effective in encouraging quit attempts and reducing cigarette consumption up to 6 months postdischarge .
CONCLUSIONS	Additional support strategies are required to facilitate longer-term cessation benefits for smokers with a mental disorder .

###25129881
OBJECTIVE	The aim of this study was test the hypothesis that homeopathy ( H ) enhances the effects of scaling and root planing ( SRP ) in patients with chronic periodontitis ( CP ) .
METHODS	50 patients with CP were randomly allocated to one of two treatment groups : SRP ( C-G ) or SRP + H ( H-G ) .
METHODS	Assessments were made at baseline and after 3 and 12 months of treatments .
METHODS	The local and systemic responses to the treatments were evaluated by clinical and serologic parameters , respectively .
RESULTS	Both groups displayed significant improvements , however , using clinical attachment gain and reductions in HDL , LDL and Total Cholesterol , Triglycerides , Glucose and Uric acid , from baseline to 1 year , as criteria for treatment success , H-G performed significantly better than C-G .
CONCLUSIONS	The findings of this 1-year follow-up randomized clinical trial suggest that homeopathic medicines , as an adjunctive to SRP , can provide significant local and systemic improvements for CP patients .

###25305762
BACKGROUND	Sublingual misoprostol , used for labor induction , produces earlier and higher peak plasma concentrations of misoprostol than vaginal or rectal misoprostol .
BACKGROUND	The sublingual route could be expected to be more effective and safer than the vaginal route and by avoiding a direct effect on the cervix , it might reduce the risk of uterine hyperstimulation and be safer .
BACKGROUND	This study aimed to compare the efficacy of 25-g sublingual misoprostol with 50-g intravaginal misoprostol for cervical ripening prior to labor induction in primiparous women .
METHODS	In a double-blind , parallel randomized controlled equivalence trial , we recruited 131 primiparous women at 36-42 weeks of gestation requiring labor induction who referred to Alzahara hospital in Rasht , Iran .
METHODS	The women were randomly assigned to receive 25-g sublingual misoprostol with vaginal placebo ( n = 63 ) or 50-g intravaginal misoprostol with sublingual placebo ( n = 63 ) .
METHODS	The dose was repeated every 4 h ( maximum 4 doses ) .
METHODS	The primary outcome was the interval from the start of induction to vaginal delivery .
RESULTS	There were no significant differences between the two groups with regard to the interval from the start of induction to vaginal delivery ( 13.2 3.07 h in the vaginal group vs. 13.1 3.46 h in the sublingual group ) , duration of active phase , Bishop Scores after 4h , and rate of the vaginal delivery under 12 h. Also , the rate of hyperstimulation , tachysystole , type of delivery , cause of cesarean section , Apgar scores less than 7 and admission to the NICU were similar in these two groups .
RESULTS	The mean dose of misoprostol applied was significantly lower in the sublingual group ( P = 0.001 ) .
CONCLUSIONS	Sublingual administration of 25-g of misoprostol appears to be as effective as 50 g intravaginal misoprostol for cervical ripening and labor induction .
BACKGROUND	This trial has been registered under IRCT 38903131096N3 .

###25287106
BACKGROUND	Optimal ventilator management for patients with acute respiratory distress syndrome ( ARDS ) remains uncertain .
BACKGROUND	Lower tidal volume ventilation appears to be beneficial , but optimal management of positive end-expiratory pressure ( PEEP ) remains unclear .
BACKGROUND	The Esophageal Pressure-Guided Ventilation 2 Trial ( EPVent2 ) aims to examine the impact of mechanical ventilation directed at maintaining a positive transpulmonary pressure ( PTP ) in patients with moderate-to-severe ARDS .
METHODS	EPVent2 is a multicentre , prospective , randomised , phase II clinical trial testing the hypothesis that the use of a PTP-guided ventilation strategy will lead to improvement in composite outcomes of mortality and time off the ventilator at 28days as compared with a high-PEEP control .
METHODS	This study will enrol 200 study participants from 11 hospitals across North America .
METHODS	The trial will utilise a primary composite end point that incorporates death and days off the ventilator at 28days to test the primary hypothesis that adjusting ventilator pressure to achieve positive PTP values will result in improved mortality and ventilator-free days .
BACKGROUND	Safety oversight will be under the direction of an independent Data and Safety Monitoring Board ( DSMB ) .
BACKGROUND	Approval of the protocol was obtained from the DSMB prior to enrolling the first study participant .
BACKGROUND	Approvals of the protocol as well as informed consent documents were also obtained from the Institutional Review Board of each participating institution prior to enrolling study participants at each respective site .
BACKGROUND	The findings of this investigation , as well as associated ancillary studies , will be disseminated in the form of oral and abstract presentations at major national and international medical specialty meetings .
BACKGROUND	The primary objective and other significant findings will also be presented in manuscript form .
BACKGROUND	All final , published manuscripts resulting from this protocol will be submitted to PubMed Central in accordance with the National Institute of Health Public Access Policy .
BACKGROUND	ClinicalTrials.gov under number NCT01681225 .

###24954156
OBJECTIVE	This study examines the impact of major depressive disorder ( MDD ) and its treatment on quality of life ( QOL ) .
METHODS	From the Sequenced Treatment Alternatives to Relieve Depression ( STAR * D ) trial , we analyzed complete data of 2280 adult MDD out-patients at entry/exit of each level of antidepressant treatments and after 12 months of entry to follow-up .
METHODS	QOL was measured using the QOL Enjoyment and Satisfaction Questionnaire ( Q-LES-Q ) .
METHODS	The proportions of patients scoring ` within-normal ' QOL ( within 10 % of Q-LES-Q community norms ) and those with ` severely impaired ' QOL ( > 2SD below Q-LES-Q community norms ) were analyzed .
RESULTS	Before treatment , no more than 3 % of MDD patients experienced ` within-normal ' QOL .
RESULTS	Following treatment , statistically significant improvements were detected ; however , the proportion of patients achieving ` within-normal ' QOL did not exceed 30 % , with > 50 % of patients experiencing ` severely impaired ' QOL .
RESULTS	Although remitted patients had greater improvements compared with non-remitters , 32-60 % continued to experience reduced QOL .
RESULTS	12-month follow-up data revealed that the proportion of patients experiencing ` within-normal ' QOL show a statistically significant decrease in non-remitters .
CONCLUSIONS	Symptom-focused treatments of MDD may leave a misleading impression that patients have recovered when , in fact , they may be experiencing ongoing QOL deficits .
CONCLUSIONS	These findings point to the need for investigating specific interventions to ameliorate QOL in MDD .

###24643488
OBJECTIVE	This intervention sought to promote healthy eating with the ultimate goal of reducing childhood obesity risk .
METHODS	Three hundred and sixty-one Latino families living on the US-Mexico border with at least one child between 7-13 years of age were eligible to participate .
METHODS	Families randomly assigned to the four-month intervention received 14 contacts with a promotora ( community health worker ) , consisting of 11 home visits and three telephone calls ; the control condition was a delayed treatment intervention .
METHODS	Children reported on their dietary intake at baseline , immediately post-intervention and at the six month follow-up visit .
RESULTS	The intervention reduced weekly consumption of fast food ( p < 0.05 ) .
RESULTS	A dose-response relationship was observed such that for every seven hours of promotora contact , monthly variety of fruits ( p < 0.01 ) and vegetables ( p < 0.01 ) increased by one .
RESULTS	No other intervention effects were observed .
CONCLUSIONS	Family-based interventions can improve children 's eating habits , with the amount of contact with the promotora being key to success .

###24754350
OBJECTIVE	Spastic pes equinovarus is a frequent pathological posture of the lower extremity .
OBJECTIVE	Botulinum toxin ( BoNT/A ) has been successfully applied to treat lower limb spasticity .
OBJECTIVE	However , the best time to initiate treatment remains unclear .
OBJECTIVE	A beneficial effect of an early treatment has been suggested in previous studies .
METHODS	A single-centre double-blind randomized placebo-controlled trial was performed to investigate the efficacy of BoNT/A to reduce muscle hypertonicity at the ankle .
METHODS	Fifty-two patients with unilateral or bilateral spastic pes equinovarus with a modified Ashworth score ( mAS ) of at least 1 + after stroke , traumatic brain injury or hypoxic encephalopathy were allocated to receive either BoNT/A or placebo treatment .
METHODS	A second , open injection was optional at week 12 .
METHODS	Patients received unilateral or bilateral injections with 230 or 460U onabotulinumtoxinA , respectively .
METHODS	The course of the mAS was explored during the open study phase .
RESULTS	Patients who had received BoNT/A treatment had lower mAS compared with placebo at week 12 ( P < 0.01 ) .
RESULTS	During the open label phase , patients from the placebo group showed further deterioration of muscle tone despite starting from a similar baseline and receiving BoNT treatment .
RESULTS	Spastic feet that had received BoNT/A in the first cycle had comparatively lower mAS scores over all follow-up data and at week 24 ( P < 0.01 ) .
CONCLUSIONS	The study demonstrates a reduction of muscular hypertonicity in spastic pes equines with BoNT/A treatment given during the first 3months after the lesion .
CONCLUSIONS	Exploratory analyses of the course of muscular hypertonicity during the open phase favour earlier to later treatment .

###25086593
BACKGROUND	Chronic obstructive pulmonary disease ( COPD ) is recognized as a systemic illness with significant extra-pulmonary features , such as exercise intolerance and muscle weakness .
BACKGROUND	Pulmonary rehabilitation has been shown to be very effective in counteracting these consequences in patients with more advanced COPD .
BACKGROUND	However , limited data is available on the efficacy of a physical exercise training programme in patients with mild to moderate COPD in primary care .
BACKGROUND	Furthermore , it is unknown if improved exercise capacity translates into enhanced daily physical activities .
BACKGROUND	The aim of this paper is to describe the design of a randomized controlled trial to assess the efficacy of a physical exercise training programme in patients with mild to moderate COPD .
METHODS	In this randomized controlled trial situated in the primary care setting , 102 patients with mild to moderate airflow obstruction ( FEV1 50 % of predicted ) , dyspnoea and a physically inactive lifestyle will be randomized to an intervention or control group .
METHODS	The intervention group receives a 4-month physical exercise training programme at a local physiotherapy practice , which includes exercise training , resistance training , breathing exercises and advises on how to increase the level of physical activity .
METHODS	The control group receives usual care , i.e. advises on how to increase the level of physical activity and a sham treatment at a local physiotherapy practice of which no physiological training stimulus can be expected .
METHODS	Primary outcome is functional exercise capacity at 4-months measured on the six-minute walk distance .
METHODS	Secondary outcomes include peripheral muscle strength , physical activity in daily life , health related quality of life , Medical Research Council ( MRC ) dyspnoea score and patients ' perceived effectiveness .
METHODS	Follow-up measurement will take place at 6 months after baseline .
CONCLUSIONS	This will be one of the first studies to evaluate the efficacy of a physical exercise training programme in patients with mild to moderate COPD completely recruited and assessed in primary care .
CONCLUSIONS	The results of this trial may give a unique insight into the potential of the implementation of an easy , close-to-home rehabilitation programme .
BACKGROUND	The Netherlands National Trial Register NTR1471 .

###25381588
OBJECTIVE	Single-site laparoscopic surgery ( SSLS ) is still only used in limited situations to treat children with appendicitis .
OBJECTIVE	Using conventional laparoscopic ( CL ) equipment to perform SSLS appendectomy is considered a valuable application in China .
OBJECTIVE	This prospective randomized trial aims to evaluate the surgical outcome of SSLS and CL appendectomy using CL equipment .
METHODS	Sixty patients were recruited and randomly assigned to receive SSLS or 3-port CL appendectomy between February 2011 and June 2013 .
METHODS	Each case of SSLS appendectomy was performed using CL instruments .
METHODS	Surgery outcomes , including operative time , conversion rates , postoperative complications , hospital stays , and hospital costs were evaluated .
RESULTS	Patient characteristics were similar between groups .
RESULTS	The SSLS using CL instruments was successful in all the 30 patients and no conversions occurred .
RESULTS	Mean operative time was longer in the SSLS group than the CL group ( 64.33.1 vs 53.02.9 min , respectively ; p = 0.000 ) .
RESULTS	Complication rates , lengths of hospital stay , and hospital costs were similar between the two groups .
CONCLUSIONS	The findings of this study demonstrate that using conventional instruments to perform SSLS is technically feasible and safe in children .
CONCLUSIONS	Although SSLS appendectomy does increase the operative time , it does not increase the complication rate and hospital cost .

###25150401
BACKGROUND	Research has shown that participation in Alcoholics Anonymous ( AA ) confers significant recovery benefit to adults suffering from alcohol use disorder ( AUD ) .
BACKGROUND	Concerns persist , however , that AA may not work as well for younger adults , who tend to have shorter addiction histories , different social circumstances , and less spiritual/religious interest than adults .
METHODS	Secondary data analysis of Project MATCH , using a prospective , moderated multiple mediation analysis to test and compare six previously identified mechanisms of change in younger adults ( n = 266 ) vs. adults aged 30 + ( n = 1460 ) .
METHODS	Nine clinical sites within the United States .
METHODS	Treatment-seeking adults ( n = 1726 ) suffering from AUD who participated in 12 weeks of outpatient treatment and completed follow-ups at 3 - , 9 - and 15-months .
METHODS	AA attendance during treatment ; mediators at 9 months ; and outcomes [ percentage of days abstinent ( PDA ) and drinks per drinking day ( DDD ) ] at 15 months .
RESULTS	AA attendance was associated with improved drinking outcomes in both younger adults ( PDA : F ( 1 , 247 ) = 8.55 , p < 0.01 ; DDD : F ( 1 , 247 ) = 15.93 , p < 0.01 ) and adults aged 30 + ( PDA : F ( 1 , 1311 ) = 86.58 , p < 0.01 ; DDD : F ( 1 , 1311 ) = 11.96 , p < 0.01 ) .
RESULTS	Only two of the six hypothesized pathways ( i.e. , decreases in pro-drinking social networks , self-efficacy in social situations ) appeared to work in younger adults .
CONCLUSIONS	Unidentified mechanisms of behavior change that are mobilized by AA participation appear to be at work in young people .
CONCLUSIONS	Once identified , these mechanisms may shed new light on how exactly AA confers similar benefits for young people and , more broadly , may enhance our understanding of recovery-related change for young adults that could yield novel intervention targets .

###24456512
OBJECTIVE	The current study was a randomized controlled trial investigating the effect of an innovative , short-term lifestyle intervention on weight gain in female freshman college students .
METHODS	Ninety-five freshmen were recruited from a large public university in the United States .
METHODS	Participants completed baseline assessments and were randomized to a 5-session , 4-week intervention or wait-list control , with assessments at posttest and 3-month follow-up .
RESULTS	The hypothesized time by group interaction was not significant , p = .393 ; however , trends suggested that control participants maintained baseline weight , whereas intervention participants lost -2.07 kg by posttest but regained 1.05 kg at follow-up .
RESULTS	Significantly more intervention participants ( 47.0 % ) decreased their daily caloric intake by 200 kcal compared with control ( 31.7 % ) , p = .050 .
CONCLUSIONS	Brief intervention to prevent weight gain was not effective in this sample .
CONCLUSIONS	Future studies should investigate lengthening the intervention to enhance effectiveness and increasing recruitment to improve statistical power .

###25456290
BACKGROUND	Seroma formation remains a significant problem in abdominoplasty procedures -- the cause of which remains to be elucidated .
BACKGROUND	It has been suggested that one of the causative factors for seroma formation is the use of handheld electrocautery as opposed to scalpel for abdominal flap dissection .
METHODS	Prospective trial in 102 consecutive abdominoplasty patients randomised to have abdominal flap dissection with either handheld electrocautery device on ` coagulation setting ' or sharp dissection with scalpel and monopolar electrocautery forceps for haemostasis .
METHODS	In all other aspects the surgical technique was identical between the two groups .
METHODS	All drains were removed at 48 h , irrespective of drain volume .
METHODS	Primary outcome measure is postoperative seroma formation on clinical examination , secondary outcome measures are drain volume , weight of tissue removed , effect of liposuction and patient BMI .
RESULTS	Both study groups were similar in demographics with no significant difference in weight of tissue excised , BMI , drain output or post operative complictions .
RESULTS	There was no significant difference in seroma formation rates between the handheld electrocautery group ( 17.2 % ) and the sharp dissection group ( 20.1 % ) .
RESULTS	Overall , the seroma rate was 18.6 % .
RESULTS	Liposuction to the flanks at the time of abdominoplasty was found to significantly increase the incidence of seroma , compared to patients having abdominoplasty alone .
CONCLUSIONS	Use of handheld electrocautery rather than scalpel for tissue dissection does not lead to increased seroma formation in abdominoplasty patients .
CONCLUSIONS	Concomitant liposuction at the time of abdominoplasty increases the risk of seroma formation compared to patients having abdominoplasty alone .

###25512434
BACKGROUND	Preclinical evidence demonstrates that inorganic nitrite , after its in situ conversion to nitric oxide , attenuates consequent myocardial reperfusion injury .
OBJECTIVE	We investigated whether intracoronary injection of nitrite during primary percutaneous coronary intervention might improve infarct size in ST-elevated myocardial infarction .
RESULTS	Patients undergoing primary percutaneous coronary intervention ( n = 80 ) were randomized to receive intracoronary ( 10 mL ) sodium nitrite ( 1.8 mol ) or NaCl ( placebo ) before balloon inflation .
RESULTS	The primary end point was infarct size assessed by measuring creatine kinase release .
RESULTS	Secondary outcomes included infarct size assessed by troponin T release and by cardiac MRI on day 2 .
RESULTS	Baseline characteristics were similar between the groups .
RESULTS	No evidence of differences in creatine kinase release ( P = 0.92 ) , troponin T ( P = 0.85 ) , or cardiac MRI-assessed infarct size ( P = 0.254 ) were evident .
RESULTS	In contrast , there was an improvement [ corrected ] in myocardial salvage index ( P = 0.05 ) and reduction in [ corrected ] major adverse cardiac event at 1 year ( 2.6 % versus 15.8 % ; P = 0.04 ) in the nitrite group .
RESULTS	In a 66-patient subgroup with thrombolysis in myocardial infarction 1 flow , there was reduced serum creatine kinase ( P = 0.030 ) and a 19 % reduction in cardiac MRI-determined infarct size ( P = 0.034 ) with nitrite .
RESULTS	No adverse effects of nitrite were detected .
CONCLUSIONS	In this phase II study , intracoronary nitrite infusion did not alter infarct size , although a trend to improved myocardial salvage index and a significant reduction in major adverse cardiac event was evident .
CONCLUSIONS	In a subgroup of patients with thrombolysis in myocardial infarction flow 1 , nitrite reduced infarct size and major adverse cardiac event and improved myocardial salvage index , indicating that a phase III clinical trial assessing intracoronary nitrite administration as an adjunct to percutaneous coronary intervention in ST-elevated myocardial infarction patients is warranted .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01584453 .

###25022821
BACKGROUND	The mechanism of action of vagus nerve stimulation ( VNS ) in intractable epilepsy is not entirely clarified .
BACKGROUND	It is believed that VNS causes alterations in cytokines , which can lead to rebalancing the release of neurotoxic and neuroprotective tryptophan metabolites .
BACKGROUND	We aimed to evaluate VNS effects on tryptophan metabolites and on epileptic seizures and investigated whether the antiepileptic effectiveness correlated with changes in tryptophan metabolism .
METHODS	Forty-one children with intractable epilepsy were included in a randomized , active-controlled , double-blind study .
METHODS	After a baseline period of 12 weeks , all children underwent implantation of a vagus nerve stimulator and entered a blinded active-controlled phase of 20 weeks .
METHODS	Half of the children received high-output ( therapeutic ) stimulation ( n = 21 ) , while the other half received low-output ( active control ) stimulation ( n = 20 ) .
METHODS	Subsequently , all children received high-output stimulation for another 19 weeks ( add-on phase ) .
METHODS	Tryptophan metabolites were assessed in plasma and cerebrospinal fluid ( CSF ) by use of liquid chromatography-tandem mass spectrometry ( LC-MS/MS ) and compared between high - and low-output groups and between the end of both study phases and baseline .
METHODS	Seizure frequency was recorded using seizure diaries .
METHODS	Mood was assessed using Profile of Mood States ( POMS ) questionnaires .
RESULTS	Regarding tryptophan metabolites , anthranilic acid ( AA ) levels were significantly higher at the end of the add-on phase compared with baseline ( p = 0.002 ) and correlated significantly with improvement of mood ( = -0.39 , p = 0.037 ) and seizure frequency reduction ( = -0.33 , p < 0.01 ) .
RESULTS	No significant changes were found between high - and low-output groups regarding seizure frequency .
CONCLUSIONS	Vagus nerve stimulation induces a consistent increase in AA , a neuroprotective and anticonvulsant tryptophan metabolite .
CONCLUSIONS	Moreover , increased AA levels are associated with improvement in mood and reduction of seizure frequency .

###24470753
BACKGROUND	This study was conducted to compare the oral bioavailability of an itopride extended-release ( ER ) formulation with that of the reference immediate-release ( IR ) formulation in the fasting state .
BACKGROUND	The effect of food on the bioavailability of itopride ER was also assessed .
METHODS	A single-center , open-label , randomized , multiple-dose , three-treatment , three-sequence , crossover study was performed in 24 healthy male subjects , aged 22-48 years , who randomly received one of the following treatments for 4 days in each period : itopride 150 mg ER once daily under fasting or fed conditions , or itopride 50 mg IR three times daily in the fasting state .
METHODS	Steady-state pharmacokinetic parameters of itopride , including peak plasma concentration ( Cmax ) and area under the plasma concentration versus time curve over 24 hours after dosing ( AUC ( 0-24h ) ) , were determined by noncompartmental analysis .
METHODS	The geometric mean ratio of the pharmacokinetic parameters was derived using an analysis of variance model .
RESULTS	A total of 24 healthy Korean subjects participated , 23 of whom completed the study .
RESULTS	The geometric mean ratio and its 90 % confidence interval of once-daily ER itopride versus IR itopride three times a day for AUC ( 0-24h ) were contained within the conventional bioequivalence range of 0.80-1 .25 ( 0.94 [ 0.88-1 .01 ] ) , although Cmax was reached more slowly and was lower for itopride ER than for the IR formulation .
RESULTS	Food delayed the time taken to reach Cmax for itopride ER , but AUC ( 0-24h ) was not affected .
RESULTS	There were no serious adverse events and both formulations were generally well tolerated .
CONCLUSIONS	At steady state , once-daily itopride ER at 150 mg has a bioavailability comparable with that of itopride IR at 50 mg given three times a day under fasting conditions .
CONCLUSIONS	Food delayed the absorption of itopride ER , with no marked change in its oral bioavailability .

###25236367
BACKGROUND	Mechanical pleurodesis is widely used to treat primary spontaneous pneumothorax to decrease postoperative recurrence after thoracoscopic bullectomy , but it is unclear whether it actually reduces primary spontaneous pneumothorax recurrence .
BACKGROUND	We aimed to investigate the effectiveness of mechanical pleurodesis after thoracoscopic treatment of primary spontaneous pneumothorax .
METHODS	In our parallel-group , prospective , randomized , controlled trail at 2 hospitals in China , 289 patients were enrolled from January 2010 to January 2013 .
METHODS	Patients were randomly assigned ( 1:1 ) to receive thoracoscopic wedge resection only ( WR group ) or thoracoscopic wedge resection and mechanical pleurodesis ( WR+MP group ) .
METHODS	This trial is registered with ClinicalTrial.gov ( NCT01463553 ) .
RESULTS	Intraoperative bleeding and postoperative pleural drainage were significantly lower in the thoracoscopic WR only group .
RESULTS	Postoperative recurrence rate did not significantly differ between groups ( log-rank test p = 0.791 ; Breslow test p = 0.722 ) .
RESULTS	In the thoracoscopic WR only group , no recurrences were found when bullae were isolated or limited ; recurrence was 7.5 % with the presence of multiple bullae .
RESULTS	Younger patients had an increased risk of recurrence ( relative risk 3.015 ; 95 % confidence interval 1.092 to 8.324 ) .
CONCLUSIONS	Thoracoscopic mechanical pleurodesis did not significantly decrease primary spontaneous pneumothorax recurrence compared with simple wedge resection , but intraoperative bleeding and postoperative pleural drainage rates were higher .
CONCLUSIONS	Younger age increases the risk of recurrence .

###25582097
OBJECTIVE	Due to time constraints that limit physician 's ability to deliver detailed contraception counseling , patients increasingly require supplemental education opportunities .
OBJECTIVE	Applications for smartphones and tablets are being designed to educate patients about contraceptive methods and simplify communication between patient and provider .
OBJECTIVE	We designed a mobile application entitled Plan A Birth Control to provide targeted information about the 10 most common , nonpermanent contraceptive methods with emphasis on long-acting reversible methods .
METHODS	We developed a mobile application designed to provide tailored information about the 10 most common nonpermanent contraceptive methods .
METHODS	After pilot testing with 40 volunteers from the clinic , 120 participants were recruited for a randomized controlled trial .
METHODS	( ClinicalTrials.gov identifier : NCT02234271 ) Participants were assigned by simple randomization to contraception counseling via tablet or health educator .
METHODS	We compared participants ' contraceptive choice between the 2 groups .
METHODS	Secondary outcomes included knowledge of the method of choice and satisfaction with counseling .
RESULTS	Of the 120 participants in the primary study , 65 chose long-acting reversible methods .
RESULTS	The uptake of long-acting reversible contraceptives was similar between the groups ( 34 received health educator counseling and 31 received mobile application counseling ) .
RESULTS	Both groups were demographically similar in age and educational status .
RESULTS	Knowledge of long-acting methods did not differ significantly between the groups ( P = .30 ) .
CONCLUSIONS	Results from our study suggest that Plan A Birth Control did not adversely affect highly effective birth control uptake in our study population .
CONCLUSIONS	This can save time for physicians and health educators if used as an adjunct to contraception counseling in waiting room settings .

###25665812
OBJECTIVE	Clinical guidelines recommend point-of-care glucose testing and the use of supplemental doses of rapid-acting insulin before meals and at bedtime for correction of hyperglycemia .
OBJECTIVE	The efficacy and safety of this recommendation , however , have not been tested in the hospital setting .
METHODS	In this open-label , randomized controlled trial , 206 general medicine and surgery patients with type 2 diabetes treated with a basal-bolus regimen were randomized to receive either supplemental insulin ( n = 106 ) at bedtime for blood glucose ( BG ) > 7.8 mmol/L or no supplemental insulin ( n = 100 ) except for BG > 19.4 mmol/L .
METHODS	Point-of-care testing was performed before meals , at bedtime , and at 3:00 a.m.
METHODS	The primary outcome was the difference in fasting BG .
METHODS	In addition to the intention-to-treat analysis , an as-treated analysis was performed where the primary outcome was analyzed for only the bedtime BG levels between 7.8 and 19.4 mmol/L .
RESULTS	There were no differences in mean fasting BG for the intention-to-treat ( 8.8 2.4 vs. 8.6 2.2 mmol/L , P = 0.76 ) and as-treated ( 8.9 2.4 vs. 8.8 2.4 mmol/L , P = 0.92 ) analyses .
RESULTS	Only 66 % of patients in the supplement and 8 % in the no supplement groups received bedtime supplemental insulin .
RESULTS	Hypoglycemia ( BG < 3.9 mmol/L ) did not differ between groups for either the intention-to-treat ( 30 % vs. 26 % , P = 0.50 ) or the as-treated ( 4 % vs. 8 % , P = 0.37 ) analysis .
CONCLUSIONS	The use of insulin supplements for correction of bedtime hyperglycemia was not associated with an improvement in glycemic control .
CONCLUSIONS	We conclude that routine use of bedtime insulin supplementation is not indicated for management of inpatients with type 2 diabetes .

###25736397
BACKGROUND	The method of administration of oral phosphodiesterase-5 inhibitors has been expanded to once-daily repeated administration with lower initial dosage than on-demand administration .
OBJECTIVE	The aim of this study was to evaluate the efficacy and safety of once-daily udenafil as a treatment for erectile dysfunction ( ED ) for intermediate-term period .
METHODS	This multicenter , randomized , double-blind clinical trial included 346 ED patients ( placebo , udenafil 50mg , udenafil 75mg ) .
METHODS	Subjects were treated with each medication once daily for 24 weeks .
METHODS	Subjects were asked to complete the International Index of Erectile Function ( IIEF ) - erectile function ( EF ) domain at baseline , 12 weeks , and 24 weeks and the development of adverse drug reactions ( ADRs ) was inspected .
RESULTS	Both dosages of udenafil induced a significant increase in IIEF-EF compared with placebo at both 12 and 24 weeks .
RESULTS	When patients were divided according to the severity of baseline EF score , significant improvement was observed only with udenafil 75mg regardless of the degree of ED .
RESULTS	At 24 weeks , the proportions of patients who reported a return to normal EF ( IIEF-EF over 26 ) were 39.1 % for udenafil 50mg and 47.0 % for udenafil 75mg .
RESULTS	In terms of safety , ADRs were observed in 6.1 % , 12.9 % , and 17.9 % for placebo , udenafil 50mg , and 75mg , respectively .
RESULTS	Although a statistically higher rate of ADRs was observed in the udenafil 75mg group ( P = 0.024 ) , the majority were mild and recovered without treatment .
CONCLUSIONS	Once-daily administration of udenafil 50mg and 75mg for 24 weeks resulted in improvement of EF .
CONCLUSIONS	In particular , udenafil 75mg improves EF regardless of the baseline degree of ED .

###24872326
BACKGROUND	Immunization of healthy volunteers by bites from Plasmodium falciparum-infected mosquitoes during chloroquine chemoprophylaxis ( hereafter , chemoprophylaxis and sporozoites [ CPS ] immunization ) induces sterile protection against malaria .
BACKGROUND	CPS-induced protection is mediated by immunity against pre-erythrocytic stages , presumably at least partially by cytotoxic cellular responses .
BACKGROUND	We therefore aimed to investigate the association of CPS-induced cytotoxic T-cell markers with protection .
METHODS	In a double-blind randomized controlled trial , we performed dose titration of CPS immunization followed by homologous challenge infection in 29 subjects .
METHODS	Immune responses were assessed by in vitro restimulation of peripheral blood mononuclear cells and flow cytometry .
RESULTS	Dose-dependent complete protection was obtained in 4 of 5 volunteers after immunization with bites from 45 P. falciparum-infected mosquitoes , in 8 of 9 volunteers with bites from 30 , and in 5 of 10 volunteers with bites from 15 ( odds ratio [ OR ] , 5.0 ; 95 % confidence interval [ CI ] , 1.5-17 ) .
RESULTS	Completely protected subjects had significantly higher proportions of CD4 T cells expressing the degranulation marker CD107a ( OR , 8.4 ; 95 % CI , 1.5-123 ; P = .011 ) and CD8 cells producing granzyme B ( OR , 11 ; 95 % CI , 1.9-212 ; P = .004 ) after P. falciparum restimulation .
CONCLUSIONS	These data underline the efficiency of CPS immunization to induce sterile protection and support a possible role for cytotoxic CD4 and CD8 T-cell responses in pre-erythrocytic immunity .
BACKGROUND	NCT01218893 .

###25182544
OBJECTIVE	We compare the safety and efficacy of ecallantide with placebo in subjects undergoing assessment for acute angiotensin-converting enzyme inhibitor-induced angioedema ( ACEIA ) in an emergency department ( ED ) .
METHODS	This was a multicenter , phase 2 , double-blind study with subjects randomized to receive a single subcutaneous dose of ecallantide ( 10 , 30 , or 60 mg ) or placebo plus physician-directed conventional therapy .
METHODS	The primary endpoint was defined as meeting predetermined discharge eligibility criteria within 6 hours of study drug administration .
METHODS	Discharge criteria included improvement of edema , stable vital signs , absence of stridor , absence of dyspnea or use of accessory muscles during respiration , absence of drooling , and ability to drink without difficulty .
RESULTS	An interim analysis showed that a high percentage of subjects met the primary endpoint , and the study was halted .
RESULTS	Overall , 79 subjects were randomized and 76 had data for analysis .
RESULTS	Most had mild ( 45 % ) or moderate ( 42 % ) ACEIA .
RESULTS	The discharge eligibility endpoint was met by 72 % of the placebo group and 85 % , 89 % , and 89 % of the ecallantide 10 - , 30 - , and 60-mg groups , respectively .
RESULTS	This difference in meeting discharge eligibility endpoint criteria between treatment groups was not statistically significant .
RESULTS	The incidence of treatment-emergent adverse events was similar between placebo and active-treatment groups .
CONCLUSIONS	The addition of ecallantide to standard therapy does not appear to improve angioedema compared with placebo in ED patients with ACEIA .
CONCLUSIONS	Our data suggest that most ED patients presenting with mild to moderate ACEIA are likely to meet our discharge eligibility criteria within 6 hours of treatment , regardless of intervention .
CONCLUSIONS	Further studies to assess the utility of ecallantide in patients with more severe angioedema may be useful .
CONCLUSIONS	No new safety signals related to ecallantide administration were identified .

###24742955
OBJECTIVE	To determine the effects of dietary-induced weight loss ( D ) and weight loss plus exercise ( D + E ) compared to exercise alone ( E ) on bone mineral density ( BMD ) in older adults with knee osteoarthritis ( OA ) .
METHODS	Data come from 284 older ( 66.0 6.2 years ) , overweight/obese ( body mass index ( BMI ) 33.4 3.7 kg/m2 ) , adults with knee OA enrolled in the Intensive Diet and Exercise for Arthritis ( IDEA ) study .
METHODS	Participants were randomized to 18 months of walking and strength training ( E ; n = 95 ) , dietary-induced weight loss targeting 10 % of baseline weight ( D ; n = 88 ) or a combination of the two ( D + E ; n = 101 ) .
METHODS	Body weight and composition ( DXA ) , regional BMD , were obtained at baseline and 18 months .
RESULTS	E , D , and D + E groups lost 1.3 4.5 kg , 9.1 8.6 kg and 10.4 8.0 kg , respectively ( P < 0.01 ) .
RESULTS	Significant treatment effects were observed for BMD in both hip and femoral neck regions , with the D and D + E groups showing similar relative losses compared to E ( both P < 0.01 ) .
RESULTS	Despite reduced BMD , fewer overall participants had T-scores indicative of osteoporosis after intervention ( 9 at 18 months vs 10 at baseline ) .
RESULTS	Within the D and D + E groups , changes in hip and femoral neck , but not spine , BMD correlated positively with changes in body weight ( r = 0.21 and 0.54 respectively , both P 0.01 ) .
CONCLUSIONS	Weight loss via an intensive dietary intervention , with or without exercise , results in bone loss at the hip and femoral neck in overweight and obese , older adults with OA .
CONCLUSIONS	Although the exercise intervention did not attenuate weight loss-associated reductions in BMD , classification of osteoporosis and osteopenia remained unchanged .
BACKGROUND	NCT00381290 .

###24503560
OBJECTIVE	To evaluate the feasibility of a low-dose contrast medium protocol for 64-detector row computed tomography angiography ( CTA ) of the neck using a low-tube-voltage/high-tube-current setting .
METHODS	A phantom study was performed using 64-detector row spiral CT at multiple tube voltage and current settings .
METHODS	Iodine contrast medium attenuation curves were acquired by processing and used to select the best contrast medium-to-noise ratio ( CNR ) .
METHODS	A prospective clinical study was then performed on 84 patients requiring neck CTA .
METHODS	Patients were randomly divided into two groups of 42 .
METHODS	Group A was examined using the conventional imaging protocol ( 120 kV , 400 mAs ) and group B was examined at 80 kV and 600 mAs along with a 50 % reduction in contrast medium dose .
METHODS	The CT dose index-volume ( CTDI ( vol ) ) , background noise ( BN ) , and CNR were measured and statistically analysed .
METHODS	Various image quality criteria were evaluated by two senior radiologists using a qualitative five-point scale .
RESULTS	Comparing group B with A , CTDIvol decreased by 54 % ( B : 27.48 mGy , A : 59.11 mGy ) , however , the CNR increased by 50 % .
RESULTS	The mean attenuation , which was caused by venous streak artefacts , was significantly lower in group B than A. Qualitative image analysis found that all criteria were significantly better for group B than A.
CONCLUSIONS	At 64-detector row spiral CT , the low-tube-voltage/high-tube-current with low-dose contrast medium protocol was superior to the conventional protocol regarding radiation dose , venous streak artefacts , and image quality , and is feasible for CTA of the neck .

###25942458
BACKGROUND	Dyslipidemia is highly prevalent among patients with HIV infection and contributes to an increased risk of cardiovascular disease .
BACKGROUND	We investigated the influence of a frequently used statin , atorvastatin , on the pharmacokinetics of the HIV-integrase inhibitor raltegravir and vice versa .
METHODS	Open-label , crossover 3-period phase I trial in 24 healthy volunteers .
METHODS	Subjects took raltegravir 400 mg two times a day for 7 days , atorvastatin 20 mg once a day for 7 days , and the combination of atorvastatin 20 mg once a day + raltegravir 400 mg two times a day for 7 days with 2-week washout periods in between .
METHODS	Intensive steady-state 12 - and 24-hour pharmacokinetic blood sampling was performed .
METHODS	Geometric mean ratios of the test treatment ( combination raltegravir + atorvastatin ) versus the reference treatment ( raltegravir or atorvastatin alone ) and 90 % confidence intervals were calculated for the area under the plasma concentration-time curve ( AUC ) .
METHODS	Fasting lipid profiles were obtained to assess short-term lipid-lowering effect of atorvastatin with or without concomitant raltegravir use .
RESULTS	Twenty-four healthy volunteers ( 11 males ) were enrolled .
RESULTS	All but 1 subject completed the trial , and no serious adverse events were reported .
RESULTS	Geometric mean ratios ( 90 % confidence interval ) were 1.01 ( 0.68-1 .51 ) for raltegravir AUC ( 0-12h ) and 1.00 ( 0.90-1 .11 ) for atorvastatin AUC ( 0-24h ) .
RESULTS	The AUC ( 0-24h ) metabolite-to-parent ratio for atorvastatin lactone , ortho-hydroxy , and para-hydroxy atorvastatin did not change during concomitant raltegravir use .
RESULTS	The effect of atorvastatin on low-density lipoprotein cholesterol was not significantly different when combined with raltegravir versus atorvastatin alone ( P = 0.638 ) .
CONCLUSIONS	Atorvastatin 20 mg has no clinically relevant effect on the pharmacokinetics of raltegravir and vice versa .
CONCLUSIONS	The combination was well tolerated and can be administered without dose adjustments .

###25138758
BACKGROUND	To compare the role of topically applied serum therapy with preservative-free artificial tear ( AT ) drops in patients with moderate to severe dry eye in Hansen 's disease along with change in tear protein profile .
METHODS	144 consecutive patients were randomly divided into three groups .
METHODS	After a baseline examination of clinical parameters , each of the patients received designated modality of topical therapy six times a day for 6weeks .
METHODS	Post-treatment documentation of clinical parameters was done at 6weeks , and then at 12weeks after discontinuation of topical therapy .
METHODS	Analysis of three tear proteins using gel electrophoresis ( sodium dodecyl sulfate polyacrylamide gel electrophoresis ) was done at baseline , at the first and second post-treatment visits .
RESULTS	In the cord blood serum ( CBS ) group , except for McMonnies score and staining score , all other clinical parameters showed continued improvement in the first and second post-treatment analyses .
RESULTS	In the autologous serum ( ALS ) group , all the clinical parameters except Schirmer 's I showed significant improvement in the first post-treatment analysis .
RESULTS	This was sustained at a significant level in the second analysis except for tear film break-up time ( TBUT ) and conjunctival impression cytology grading .
RESULTS	In the AT group , all the parameters improved at a non-significant level except for TBUT in the first analysis .
RESULTS	In the next analysis , apart from McMonnies score and TBUT , other clinical parameters did not improve .
RESULTS	In the ALS and CBS groups , tear lysozyme , lactoferrin levels improved in both post-treatment measurements ( statistically insignificant ) .
RESULTS	Total tear protein continued to increase at statistically significant levels in the first and second post-treatment analyses in the CBS group and at a statistically insignificant level in the ALS group .
RESULTS	In the AT group , the three tear proteins continued to decrease in both the analyses .
CONCLUSIONS	In moderate to severe dry eye in Hansen 's disease , serum therapy in comparison with AT drops , improves clinical parameters and causes betterment in tear protein profile .
BACKGROUND	CTRI/2013/07 / 003802 .

###25822284
OBJECTIVE	Heart failure ( HF ) has a major effect on patients ' health status , including their symptom burden , functional status , and health-related quality of life .
OBJECTIVE	To determine the effectiveness of a collaborative care patient-centered disease management ( PCDM ) intervention to improve the health status of patients with HF .
METHODS	The Patient-Centered Disease Management ( PCDM ) trial was a multisite randomized clinical trial comparing a collaborative care PCDM intervention with usual care in patients with HF .
METHODS	A population-based sample of 392 patients with an HF diagnosis from 4 Veterans Affairs centers who had a Kansas City Cardiomyopathy Questionnaire ( KCCQ ) overall summary score of less than 60 ( heavy symptom burden and impaired functional status and quality of life ) were enrolled between May 2009 and June 2011 .
METHODS	The PCDM intervention included collaborative care by a multidisciplinary care team consisting of a nurse coordinator , cardiologist , psychiatrist , and primary care physician ; home telemonitoring and patient self-management support ; and screening and treatment for comorbid depression .
METHODS	The primary outcome was change in the KCCQ overall summary score at 1 year ( a 5-point change is clinically significant ) .
METHODS	Mortality , hospitalization , and depressive symptoms ( Patient Health Questionnaire 9 ) were secondary outcomes .
RESULTS	There were no significant differences in baseline characteristics between patients randomized to the PCDM intervention ( n = 187 ) vs usual care ( n = 197 ) ; baseline mean KCCQ overall summary scores were 37.9 vs 36.9 ( P = .48 ) .
RESULTS	There was significant improvement in the KCCQ overall summary scores in both groups after 1 year ( mean change , 13.5 points in each group ) , with no significant difference between groups ( P = .97 ) .
RESULTS	The intervention was not associated with greater improvement in the KCCQ overall summary scores when the effect over time was estimated using 3-month , 6-month , and 12-month data ( P = .74 ) .
RESULTS	Among secondary outcomes , there were significantly fewer deaths at 1 year in the intervention arm ( 8 of 187 [ 4.3 % ] ) than in the usual care arm ( 19 of 197 [ 9.6 % ] ) ( P = .04 ) .
RESULTS	Among those who screened positive for depression , there was a greater improvement in the Patient Health Questionnaire 9 scores after 1 year in the intervention arm than in the usual care arm ( 2.1 points lower , P = .01 ) .
RESULTS	There was no significant difference in 1-year hospitalization rates between the intervention arm and the usual care arm ( 29.4 % vs 29.9 % , P = .87 ) .
CONCLUSIONS	This multisite randomized trial of a multifaceted HF PCDM intervention did not demonstrate improved patient health status compared with usual care .
BACKGROUND	clinicaltrials.gov Identifier : NCT00461513 .

###24411152
BACKGROUND	Low back pain is highly prevalent in patients with HTLV-1 .
BACKGROUND	The effects of physical activity on this condition are not known , but postural misalignment and motor deficits are frequently present .
OBJECTIVE	To assess the effect of Pilates exercises on chronic low back pain in these patients , and its impact on quality of life .
METHODS	A randomized crossover clinical trial was conducted , involving 22 patients from a reference center in Salvador , Bahia , Brazil .
METHODS	The VAS was used to evaluate the effect of Pilates on pain intensity and the SF-36 to assess its impact on quality of life .
RESULTS	Our results provide evidence of positive effects on pain intensity and almost all domains of quality of life when patients followed the Pilates exercise program described .
CONCLUSIONS	The Pilates method may be a useful tool in alleviating the symptoms of low back pain , and had a significant impact on quality of life in this sample of patients .

###24982494
BACKGROUND	Communication is essential for triage , but intervention trials to improve it are scarce .
BACKGROUND	Referral Writer ( RW ) , a referral letter software program , enables documentation of clinical data and extracts relevant patient details from clinical software .
OBJECTIVE	To evaluate whether specialists are more confident about scheduling appointments when they receive more information in referral letters .
METHODS	Single-blind , parallel-groups , controlled design with a 1:1 randomisation .
METHODS	Australian GPs watched video vignettes virtually .
METHODS	GPs wrote referral letters after watching vignettes of patients with cancer symptoms .
METHODS	Letter content was scored against a benchmark .
METHODS	The proportions of referral letters triagable by a specialist with confidence , and in which the specialist was confident the patient had potentially life-limiting pathology were determined .
METHODS	Categorical outcomes were tested with ( 2 ) and continuous outcomes with t-tests .
METHODS	A random-effects logistic model assessed the influence of group randomisation ( RW versus control ) , GP demographics , clinical specialty , and specialist referral assessor on specialist confidence in the information provided .
RESULTS	The intervention ( RW ) group referred more patients and scored significantly higher on information relayed ( mean difference 21.6 [ 95 % confidence intervals { CI } = 20.1 to 23.2 ] ) .
RESULTS	There was no difference in the proportion of letters for which specialists were confident they had sufficient information for appointment scheduling ( RW 77.7 % versus control 80.6 % , P = 0.16 ) .
RESULTS	In the logistic model , limited agreement among specialists contributed substantially to the observed differences in appointment scheduling ( P = 35 % [ 95 % CI 16 % to 59 % ] ) .
CONCLUSIONS	In isolation , referral letter templates are unlikely to improve the scheduling of specialist appointments , even when more information is relayed .

###25241544
OBJECTIVE	The clinical results of restoring defective teeth with two types of glass fiber prothetic systems is investigated to acquire clinical experience for further application of glass fiber posts with independent intellectual property rights .
METHODS	A total of 120 out-patients with restored defective teeth were selected from the Department of Stomatology , Beijing Xuanwu Hospital of Traditional Chinese Medicine and Peking University School and Hospital of Stomatology and randomly divided into two groups .
METHODS	OUYA FIBER posts and Tenax Fiber White posts were used to restore defective teeth in the experimental group and the control group , respectively .
METHODS	Clinical evaluation was conducted one week and three months post-restoration .
RESULTS	Both clinical satisfactory rates of OUYA FIBER posts and Tenax Fiber White posts were higher than 98 % one week post-restoration and higher than 96 % three months post-restoration .
RESULTS	No significant differences were observed between the clinical results of restoring defective teeth with the two types of fiber posts .
RESULTS	Throughout the healing process , no root canal fracture or marginal staining were observed .
CONCLUSIONS	OUYA FIBER post and Tenax Fiber White post showed similar clinical outcomes during the period of observation in this study .
CONCLUSIONS	However , the long-term effects should be observed in future studies .

###26086157
BACKGROUND	Delayed gastric emptying ( DGE ) is a major problem after pancreatoduodenectomy ( PD ) .
BACKGROUND	A recent multicentre randomized trial reported no difference in gastric emptying rates between retrocolic and antecolic reconstruction routes .
BACKGROUND	The present study looked at quality of life with these two approaches and the correlation with gastric emptying .
METHODS	This was a substudy of patients completing a panel of quality-of-life questionnaires within a randomized trial comparing retrocolic and antecolic gastroenteric reconstruction after PD .
METHODS	Gastric emptying was assessed by scintigraphy 1week after surgery .
METHODS	Quality of life was measured with the EuroQoL - 5D questionnaire ( EQ-5D ) , the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire ( QLQ-C30 ) with its pancreatic cancer module ( PAN26 ) , and the Gastrointestinal Quality of Life Index ( GIQLI ) .
RESULTS	There were 38 patients in the retrocolic and 35 in the antecolic group .
RESULTS	Baseline characteristics and clinical outcomes were similar in the two groups .
RESULTS	Median time to half-emptying of stomach content after surgery was 145 and 64min in the retrocolic and antecolic group respectively ( P = 0.189 ) .
RESULTS	Median percentages of residual activity after 2h were 64 and 28 per cent respectively ( P = 0.213 ) .
RESULTS	Quality of life did not differ at any time point between the groups .
RESULTS	At 2weeks after surgery , patients with DGE had significantly worse outcomes on two EQ-5D domains , ten QLQ-C30 / PAN26 subscales , and two GIQLI subscales and total score .
RESULTS	Effect sizes were moderate to large .
CONCLUSIONS	The route of gastroenteric reconstruction after PD does not influence either gastric emptying at scintigraphy or quality of life .
CONCLUSIONS	The impact of DGE on quality of life is clinically significant .
CONCLUSIONS	Registration number NTR1697 ( www.trialregister.nl ) .

###24378599
BACKGROUND	Switches between anti-tumor necrosis factor agents in the treatment of Crohn 's disease ( CD ) occur in case of treatment failure , intolerance , or patient preference .
BACKGROUND	No data are currently available on the usefulness of a second infliximab treatment after earlier discontinuation and previous switch to an alternative anti-tumor necrosis factor agent .
BACKGROUND	In this study , we evaluated the clinical benefit of infliximab retreatment in patients with CD after sequential use of both infliximab and adalimumab .
METHODS	Twenty-nine patients with CD who had received earlier treatments with sequential infliximab and adalimumab and were then restarted on infliximab were retrieved from a multicenter registry designed for the follow-up of adalimumab treatment for CD .
METHODS	Short-term and sustained effects of infliximab retreatment were evaluated retrospectively by reviewing clinical records .
METHODS	Follow-up was 18 months for all patients .
RESULTS	In 13/29 ( 45 % ) patients , infliximab was reintroduced at intensified dosing schedule ( > 5 mg/kg or < 8 wk ) for 23/29 ( 79 % ) of patients similar to the schedule who were on at time of previous discontinuation .
RESULTS	During the second infliximab treatment course , dosing was further intensified in 11 out of 29 ( 38 % ) patients .
RESULTS	After 18 months 18/29 ( 62 % ) , patients were still on continued therapy of their second infliximab treatment .
RESULTS	Infliximab was discontinued ( after a median of 7 mo ) in 11 out of 29 patients for loss of response ( n = 7 [ 24 % ] ) , intolerance ( n = 3 [ 10 % ] ) , or non-compliance ( n = 1 [ 3 % ] ) .
RESULTS	Use of induction schedule or concomitant immunomodulators were not significantly associated with treatment benefit .
CONCLUSIONS	The majority of patients with CD benefit from a second treatment with infliximab after previous treatment with infliximab and adalimumab , which offer a meaningful therapeutic option in often highly refractory patients .

###25566620
OBJECTIVE	To evaluate the efficacy and safety of Yindan Xinnaotong Soft Capsule ( YXSC ) on cerebral infarction ( CI ) reconvalescents of static blood blocking collaterals syndrome ( SBBCS ) .
METHODS	Totally 118 CI reconvalescents of SBBCS were randomly assigned to the test group ( treated by YXSC ) and the control group [ treated by Naoxintong Capsule ( NC ) ] , 59 in each group .
METHODS	The therapeutic course for all was 12 weeks .
METHODS	Changes of National Institute of Health Stroke Scale ( NIHSS ) , Barthel Index ( BI ) , modified Rankin Scale ( mRS ) , Chinese medical syndrome scores , and serum lipid indices were observed in the two groups .
RESULTS	Compared with the control group , the patient proportion of improving activities of daily life by more than or equal to 75 score was elevated ( 80.7 % vs 62.5 % ; P < 0.05 ) .
RESULTS	Compared with before treatment in the same group , the NIHSS score decreased at post-treatment 4 , 8 , and 12 weeks in the two groups ( P < 0.05 ) .
RESULTS	The patient proportion of dropped NIHSS score by more than or equal to 5 score was lowered ( 80.7 % vs 57.14 % ) , and the total effective rate of improving Chinese medical syndromes was superior in the test group after 12-week treatment ( 89.47 % vs 71.43 % , all P < 0.05 ) .
RESULTS	After 12-week treatment there was no statistical difference in the patient proportion of lowering mRS lower than or equal to 2 or blood lipids between the two groups ( P > 0.05 ) .
CONCLUSIONS	YXSC showed certain effect in improving activities of daily life , attenuating the neurological impairment , and elevating the total effective rate of improving Chinese medical syndromes in CI patients in the recovery stage .

###25891549
OBJECTIVE	Compare relapse clinical severity , post-relapse residual disability , and the probability of confirmed complete recovery from relapse between patients who relapsed during natalizumab ( n = 183/627 [ 29 % ] ) and placebo ( n = 176/315 [ 56 % ] ) treatments in the AFFIRM trial .
METHODS	In this post-hoc analysis , relapse clinical severity and residual disability were defined by change in Expanded Disability Status Scale ( EDSS ) score occurring between pre-relapse and at-relapse assessment and between pre-relapse and post-relapse assessment , respectively .
METHODS	Patients were considered completely recovered from relapse when their post-relapse EDSS score was less than or equal to their pre-relapse EDSS score , and this was maintained for 12 or 24 weeks .
RESULTS	At relapse , an increase in EDSS score of 0.5 points occurred in 71 % of natalizumab and 84 % of placebo patients ( P = 0.0088 ) ; an increase of 1.0 point occurred in 49 % of natalizumab and 61 % of placebo patients ( P = 0.0349 ) ( mean increase in EDSS at relapse : natalizumab = 0.77 ; placebo = 1.09 ; P = 0.0044 ) .
RESULTS	After relapse , residual disability of 0.5 EDSS points remained in 31 % of natalizumab and 45 % of placebo patients ( P = 0.0136 ) ( mean post-relapse residual EDSS increase : natalizumab = 0.06 ; placebo = 0.28 ; P = 0.0170 ) .
RESULTS	In patients with an increase in EDSS of 0.5 or 1.0 during relapse , natalizumab increased the probability of 12-week confirmed complete recovery from relapse by 55 % ( hazard ratio [ HR ] = 1.554 ; P = 0.0161 ) and 67 % ( HR = 1.673 ; P = 0.0319 ) compared to placebo , respectively .
CONCLUSIONS	In AFFIRM , natalizumab treatment decreased the clinical severity of relapses and improved recovery from disability induced by relapses .
CONCLUSIONS	These beneficial effects would limit the step-wise accumulation of disability .

###24760962
BACKGROUND	Reduction of infarct size by ischemic postconditioning ( IPost ) has been reported in smaller proof-of-concept clinical studies , but has not been confirmed in other smaller studies .
BACKGROUND	The principle needs to be evaluated in larger groups of ST-elevation myocardial infarction ( STEMI ) patients before being implemented in clinical practice .
BACKGROUND	This study assessed the effect of ischemic postcoditioning ( IPost ) on infarct size in patients with STEMI treated by primary percutaneous coronary intervention ( PCI ) .
RESULTS	Patients with first-time STEMI , < 6 hours from symptom onset , referred to primary PCI were randomized to IPost or control groups .
RESULTS	IPost was administered by 4 cycles of 1-minute reocclusion and 1-minute reperfusion , starting 1 minute after opening , followed by stenting .
RESULTS	In the control group , stenting was performed immediately after reperfusion .
RESULTS	The primary endpoint was infarct size measured by cardiac magnetic resonance after 4 months .
RESULTS	A total of 272 patients were randomized .
RESULTS	Infarct size ( percent of left ventricular mass ) after 4 months ( median values and interquartile range ) was 14.4 % ( 7.7 , 24.6 ) and 13.5 % ( 8.1 , 19.3 ) in the control group and IPost group , respectively ( P = 0.18 ) .
RESULTS	No significant impact of IPost was found when controlling for baseline risk factors of infarct size in a multivariate linear regression model ( P = 0.16 ) .
RESULTS	The effects of IPost on secondary endpoints , including markers of necrosis , myocardial salvage , and ejection fraction , as well as adverse cardiac events during follow-up , were consistently neutral .
CONCLUSIONS	In contrast to several smaller trials reported previously , we found no significant effects of IPost on infarct size or secondary study outcomes .
BACKGROUND	http://www.clinicaltrials.gov Unique identifier : NCT.No.PO1506 .

###24673738
OBJECTIVE	The present study aimed at investigating the effects of Lactobacillus casei 01 supplementation on symptoms and inflammatory biomarkers of rheumatoid arthritis ( RA ) in women .
METHODS	In this randomized double-blind clinical trial , female patients with established RA for more than 1 year , 20-80 years of age and body mass index ( BMI ) lower than 40 , who followed stable medication for 3 months prior to the supplementation , were randomly allocated to receive either one capsule containing 10 ( 8 ) colony forming units ( CFU ) of L. casei 01 , or a placebo for 8 weeks ; allocation was stratified by BMI and menopausal status .
METHODS	Disease activity score-28 ( DAS28 ) was calculated , European League Against Rheumatism ( EULAR ) response was evaluated and the cytokines , interleukin ( IL ) -1 , IL-6 , IL-10 , IL-12 and tumor necrosis factor ( TNF ) - were measured .
RESULTS	Thirty patients were recruited in each group ; 22 and 24 patients were analyzed in the probiotic and placebo groups , respectively .
RESULTS	L. casei 01 supplementation decreased serum high-sensitivity C-reactive protein ( hs-CRP ) levels , tender and swollen joint counts , global health ( GH ) score and DAS28 ( P < 0.05 ) .
RESULTS	More patients in the L. casei 01 group had moderate response to the treatment , based on the EULAR criteria , at the end of the study ( P < 0.01 ) .
RESULTS	At the end of the study , a significant difference was observed between the two groups for IL-10 , IL-12 and TNF - changes through the study course ( P < 0.05 ) , in favor of the probiotic group .
RESULTS	No adverse effects were reported for the intervention .
CONCLUSIONS	Probiotic supplementation may be an appropriate adjunct therapy for RA patients and help alleviate symptoms and improve inflammatory cytokines .

###25143342
BACKGROUND	In-home iron fortification for infants in developing countries is recommended for control of anaemia , but low absorption typically results in > 80 % of the iron passing into the colon .
BACKGROUND	Iron is essential for growth and virulence of many pathogenic enterobacteria .
BACKGROUND	We determined the effect of high and low dose in-home iron fortification on the infant gut microbiome and intestinal inflammation .
METHODS	We performed two double-blind randomised controlled trials in 6-month-old Kenyan infants ( n = 115 ) consuming home-fortified maize porridge daily for 4 months .
METHODS	In the first , infants received a micronutrient powder ( MNP ) containing 2.5 mg iron as NaFeEDTA or the MNP without iron .
METHODS	In the second , they received a different MNP containing 12.5 mg iron as ferrous fumarate or the MNP without the iron .
METHODS	The primary outcome was gut microbiome composition analysed by 16S pyrosequencing and targeted real-time PCR ( qPCR ) .
METHODS	Secondary outcomes included faecal calprotectin ( marker of intestinal inflammation ) and incidence of diarrhoea .
METHODS	We analysed the trials separately and combined .
RESULTS	At baseline , 63 % of the total microbial 16S rRNA could be assigned to Bifidobacteriaceae but there were high prevalences of pathogens , including Salmonella Clostridium difficile , Clostridium perfringens , and pathogenic Escherichia coli .
RESULTS	Using pyrosequencing , + FeMNPs increased enterobacteria , particularly Escherichia/Shigella ( p = 0.048 ) , the enterobacteria/bifidobacteria ratio ( p = 0.020 ) , and Clostridium ( p = 0.030 ) .
RESULTS	Most of these effects were confirmed using qPCR ; for example , + FeMNPs increased pathogenic E. coli strains ( p = 0.029 ) .
RESULTS	+ FeMNPs also increased faecal calprotectin ( p = 0.002 ) .
RESULTS	During the trial , 27.3 % of infants in +12.5 mgFeMNP required treatment for diarrhoea versus 8.3 % in -12.5 mgFeMNP ( p = 0.092 ) .
RESULTS	There were no study-related serious adverse events in either group .
CONCLUSIONS	In this setting , provision of iron-containing MNPs to weaning infants adversely affects the gut microbiome , increasing pathogen abundance and causing intestinal inflammation .
BACKGROUND	NCT01111864 .

###25227477
OBJECTIVE	The control of labor pain and the prevention of suffering are major concerns of clinicians and their patients .
OBJECTIVE	The aim of this study was to evaluate the effect of music on labor pain and anxiety , maternal hemodynamics , fetal-neonatal parameters and postpartum analgesic requirement in primiparous women .
METHODS	Overall , 156 primiparous women who expected vaginal delivery were recruited and randomly assigned to a music group ( n = 77 ) or a control group ( n = 79 ) .
METHODS	Women in the music group listened to music during labor .
METHODS	Pain intensity and anxiety level were measured using a visual analogue scale ( 0-10 cm ) .
METHODS	The two groups were compared in terms of pain severity , anxiety level , maternal hemodynamics , fetal-neonatal parameters and postpartum analgesic requirement .
RESULTS	Mothers in the music therapy group had a lower level of pain and anxiety compared with those in the control group at all stages of labor ( p < 0.001 ) .
RESULTS	A signicant difference was observed between the two groups in terms of maternal hemodynamics and fetal heart rate after intervention ( p < 0.01 ) .
RESULTS	Postpartum analgesic requirement significantly decreased in the music therapy group ( p < 0.01 ) .
CONCLUSIONS	Listening to music during labor has a positive impact on labor pain and anxiety , maternal-fetal parameters and analgesic requirement .

###25060019
OBJECTIVE	The aim of the study was to determine native coronary artery patency 1 year after coronary artery bypass grafting and to identify clinical and angiographic predictors for the development of a chronic total occlusion ( CTO ) .
BACKGROUND	In contrast to the large body of information regarding graft patency , data regarding atherosclerosis progression and vessel patency in surgically bypassed native coronary arteries arelessclear .
METHODS	Of the 440 patients who underwent 1-year follow-up angiography as part of the multicenter RAPS ( Radial Artery Patency Study ) , included in our study were 388 patients ( 88 % ) for whom angiograms were available for review .
METHODS	Angiograms were reviewed for native coronary artery patency in an independent blinded manner .
RESULTS	On the pre-operative angiogram , CTO of at least 1 native coronary vessel was demonstrated in240 patients ( 61.9 % ) having 305 occluded vessels .
RESULTS	At 1 year after coronary artery bypass grafting , atleast 1 new native coronary artery CTO occurred in 169 patients ( 43.6 % ) .
RESULTS	In 7.5 % of patients , the native artery and the graft supplying that territory were both occluded .
RESULTS	A new CTO was almost 5 times more likely to occur in coronary vessels with a pre-operative proximal stenosis > 90 % compared with vessels with proximal stenosis < 90 % ( 45.5 % vs. 9.5 % , respectively , p < 0.001 ) .
RESULTS	Patients with a new CTO had significantly more baseline Canadian Cardiovascular Society class 4 angina compared with patients without a new CTO .
RESULTS	A new CTO was less likely to occur in the left anterior descending artery ( 18.4 % ) , supplied by the left internal thoracic artery .
RESULTS	When comparing radial artery and saphenous veingrafts , neither the type of graft nor graft patency had any association with native coronary artery occlusion .
CONCLUSIONS	CTO of surgically bypassed coronary arteries 1 year after coronary artery bypass grafting is extremely common .

###26267623
BACKGROUND	It is unclear whether using fetal electrocardiographic ( ECG ) ST-segment analysis as an adjunct to conventional intrapartum electronic fetal heart-rate monitoring modifies intrapartum and neonatal outcomes .
METHODS	We performed a multicenter trial in which women with a singleton fetus who were attempting vaginal delivery at more than 36 weeks of gestation and who had cervical dilation of 2 to 7 cm were randomly assigned to `` open '' or `` masked '' monitoring with fetal ST-segment analysis .
METHODS	The masked system functioned as a normal fetal heart-rate monitor .
METHODS	The open system displayed additional information for use when uncertain fetal heart-rate patterns were detected .
METHODS	The primary outcome was a composite of intrapartum fetal death , neonatal death , an Apgar score of 3 or less at 5 minutes , neonatal seizure , an umbilical-artery blood pH of 7.05 or less with a base deficit of 12 mmol per liter or more , intubation for ventilation at delivery , or neonatal encephalopathy .
RESULTS	A total of 11,108 patients underwent randomization ; 5532 were assigned to the open group , and 5576 to the masked group .
RESULTS	The primary outcome occurred in 52 fetuses or neonates of women in the open group ( 0.9 % ) and 40 fetuses or neonates of women in the masked group ( 0.7 % ) ( relative risk , 1.31 ; 95 % confidence interval , 0.87 to 1.98 ; P = 0.20 ) .
RESULTS	Among the individual components of the primary outcome , only the frequency of a 5-minute Apgar score of 3 or less differed significantly between neonates of women in the open group and those in the masked group ( 0.3 % vs. 0.1 % , P = 0.02 ) .
RESULTS	There were no significant between-group differences in the rate of cesarean delivery ( 16.9 % and 16.2 % , respectively ; P = 0.30 ) or any operative delivery ( 22.8 % and 22.0 % , respectively ; P = 0.31 ) .
RESULTS	Adverse events were rare and occurred with similar frequency in the two groups .
CONCLUSIONS	Fetal ECG ST-segment analysis used as an adjunct to conventional intrapartum electronic fetal heart-rate monitoring did not improve perinatal outcomes or decrease operative-delivery rates .
CONCLUSIONS	( Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and Neoventa Medical ; ClinicalTrials.gov number , NCT01131260 . )

###24416905
OBJECTIVE	To compare the therapeutic effects of arthroscopy and manipulation of Traditional Chinese medicine ( TCM ) in the treatment of patellofemoral joint disease .
METHODS	The patients met with the criteria of patellofemoral joint disease were divided into manipulation of TCM group and arthroscopy group randomly , 31 patients in each group .
METHODS	There were 31 patients in manipulation of TCM group , including 4 males and 27 females , with an average age of ( 52.83 + / - 5.79 ) years old ; and the patients were treated with manipulation .
METHODS	There were 31 patients in arthroscopy group , including 8 males and 23 females , with an average age of ( 54.14 + / - 6.12 ) years old ; the patients were treated with arthroscopy .
METHODS	The HSS knee joint score , fitness angle of patellofemoral joint and lateral angle of patellofemoral joint in X-ray were compared in each group and between the two groups before and after treatment respectively .
RESULTS	The two therapeutics had equally efficacious in which improved HSS score significantly .
RESULTS	After treatment , the HSS scores in manipulation of TCM group and arthroscopy group were 94.80 + / - 7.26 and 88.65 + / - 5.79 separately , the score in manipulation of TCM group was higher than that of arthroscopy group .
RESULTS	Comparing with the arthroscopy group , lateral angle of patellofemoral joint with weight-hearing position were improved significantly in manipulation of TCM group .
CONCLUSIONS	Arthroscopy and manipulation of TCM have equally efficacious in the treatment of patellofemoral joint disease , but manipulation has advantage of minimal trauma , and is better to treat patella extraversion .

###24616624
BACKGROUND	Noninvasive blood pressure ( NIBP ) monitoring methods are widely used in critically ill patients despite poor evidence of their accuracy .
BACKGROUND	The erroneous interpretations of blood pressure ( BP ) may lead to clinical errors .
OBJECTIVE	To test the accuracy and reliability of aneroid ( ABP ) and oscillometric ( OBP ) devices compared to the invasive BP ( IBP ) monitoring in an ICU population .
METHODS	Fifty adult patients ( 200 comparisons ) were included in a randomized crossover trial .
METHODS	BP was recorded simultaneously by IBP and either by ABP or by OBP , taking IBP as gold standard .
RESULTS	Compared with ABP , IBP systolic values were significantly higher ( mean difference standard deviation 9.74 13.8 ; P < 0.0001 ) .
RESULTS	Both diastolic ( -5.13 7.1 ; P < 0.0001 ) and mean ( -2.14 7.1 ; P = 0.0033 ) IBP were instead lower .
RESULTS	Compared with OBP , systolic ( 10.80 14.9 ; P < 0.0001 ) and mean ( 5.36 7.1 ; P < 0.0001 ) IBP were higher , while diastolic IBP ( -3.62 6.0 ; P < 0.0001 ) was lower .
RESULTS	Bland-Altman plots showed wide limits of agreement in both NIBP-IBP comparisons .
CONCLUSIONS	BP measurements with different devices produced significantly different results .
CONCLUSIONS	Since in critically ill patients the importance of BP readings is often crucial , noninvasive techniques can not be regarded as reliable alternatives to direct measurements .

###24939380
BACKGROUND	Radiofrequency technology for shoulder instability was rapidly adopted despite limited clinical evidence and a poor understanding of its indications .
BACKGROUND	Reports of serious adverse events followed , leading to its abandonment .
BACKGROUND	This paper presents findings from a multicenter randomized clinical trial evaluating the safety and efficacy of electrothermal arthroscopic capsulorrhaphy ( ETAC ) compared with open inferior capsular shift ( ICS ) and reviews the role of randomized trials in adopting new technology .
METHODS	Patients ( > 14years ) diagnosed with multidirectional instability or multidirectional laxity with anteroinferior instability and failed nonoperative treatment were enrolled .
METHODS	Patients with bone lesions or labral , biceps anchor , or full-thickness rotator cuff tears were excluded intraoperatively .
METHODS	Outcomes included Western Ontario Shoulder Instability Index , function and recurrent instability at 2 years postoperatively , and surgical times .
RESULTS	Fifty-four subjects ( mean age , 23years ; 37 women ) were randomized to ETAC ( n = 28 ) or open ICS ( n = 26 ) .
RESULTS	The groups were comparable at baseline , except for external rotation at the side .
RESULTS	At 2 years postoperatively , there were no statistically or clinically significant differences between groups for the Western Ontario Shoulder Instability Index ( P = .71 ) , American Shoulder and Elbow Surgeons score ( P = .43 ) , Constant score ( P = .43 ) , and active range of motion .
RESULTS	Recurrent instability was not statistically different ( ETAC ,2 ; open ,4 ; P = .41 ) .
RESULTS	ETAC ( 23minutes ) was significantly shorter than open ICS ( 59minutes ) ( P < .01 ) surgery .
RESULTS	Three subjects ( 1 ETAC , 2 open ) had stiff shoulders .
CONCLUSIONS	At 2 years postoperatively , quality of life and functional outcomes between groups were not clinically different .
CONCLUSIONS	ETAC had fewer complications and episodes of recurrence compared with open surgery .
CONCLUSIONS	This evidence reinforces the need to critically evaluate new technology before widespread clinical use .

###24333244
OBJECTIVE	We compared the safety and efficacy of bipolar transurethral resection and monopolar resection for bladder tumors .
METHODS	A single center , parallel arm , randomized , controlled trial was performed from May 2011 to August 2012 .
METHODS	All patients with suspected bladder tumors were eligible for study inclusion .
METHODS	Those who refused consent and those undergoing routine restaging transurethral resection of bladder tumor were excluded from analysis .
METHODS	The primary end point was the incidence of obturator jerk .
METHODS	Secondary study outcomes included the decrease in hematocrit , rates of recoagulation and transfusion , bladder perforation , decrease in sodium , resection syndrome and resection time .
METHODS	Pathological quality was assessed by comparing deep muscle and the degree of severe cautery artifact in the 2 arms .
RESULTS	A total of 257 transurethral resections were performed during the study period .
RESULTS	After exclusion 147 patients were randomized , including 75 in the monopolar arm and 72 in the bipolar arm .
RESULTS	There were 6 and 4 protocol violations in the monopolar and bipolar arms , respectively .
RESULTS	Intent to treat and per protocol analyses were performed .
RESULTS	The incidence of obturator jerk was greater in the bipolar arm ( 60 % vs 49.2 % , p = 0.27 ) .
RESULTS	There was no significant difference between secondary outcomes .
RESULTS	The only significant difference was a significantly lower incidence of severe cautery artifact in the bipolar arm ( 25 % vs 46.7 % , p = 0.0096 ) .
CONCLUSIONS	Bipolar transurethral resection of bladder tumor was not superior to monopolar resection with respect to obturator jerk , bladder perforation and hemostasis .
CONCLUSIONS	There was a significantly lower incidence of severe cautery artifact after bipolar resection .

###24814388
OBJECTIVE	Safety and tolerability of peginterferon-based hepatitis C virus ( HCV ) infection therapy remains suboptimal , even when direct-acting antiviral agents are added .
OBJECTIVE	This study assessed the efficacy , safety and tolerability of mericitabine combined with ritonavir-boosted danoprevir ( danoprevir/r ) ribavirin for up to 24 weeks in treatment-nave HCV genotype ( G ) 1 infected patients .
METHODS	Patients received twice daily mericitabine ( 1000 mg ) and danoprevir/r ( 100 mg/100 mg ) plus either ribavirin ( 1000/1200 mg/day ; Arm A ) or placebo ( Arm B ) for 12 or 24 weeks .
METHODS	Patients with HCV RNA < 43 IU/ml between Weeks 2 and 8 and HCV RNA < 15 IU/ml at Week 10 were rerandomized ( 1:1 ) at Week 12 to discontinue/continue assigned regimens until Week 24 .
METHODS	Because of unacceptable relapse rates in both 12-week arms and in ribavirin-free Arm B , treatment was extended to 24 weeks and patients in Arm B received peginterferon alfa-2a / ribavirin .
METHODS	The primary outcome was sustained virological response 24 weeks after end of treatment ( SVR24 ) .
RESULTS	In Arm A , the SVR24 rate in patients receiving 24 weeks of therapy was 37.9 % ( 25/66 ) ; 63.6 % ( 14/22 ) in G1b and 25.0 % ( 11/44 ) in G1a patients .
RESULTS	Virologic breakthrough and relapse were associated with danoprevir-resistant virus in most cases .
RESULTS	The mericitabine-resistance mutation ( NS5BS282T ) was detected in two patients bearing dual resistant virus NS3 R155K/NS5B S282T and dual resistance mutation L159F/L320F in one patient .
RESULTS	Treatment was safe and well tolerated .
CONCLUSIONS	Mericitabine , danoprevir/r plus ribavirin for 24 weeks were safe and well tolerated .
CONCLUSIONS	However , SVR rates were poor , achieving rates of only 25.0 % in G1a and 63.6 % in G1b patients .

###24980440
BACKGROUND	To evaluate and compare 6-month effects of 8weeks of an integrative treatment ( IT ) , therapeutic acupuncture ( TA ) , and conventional treatment ( CT ) in reducing symptoms of anxiety , depression and in improving health-related quality of life ( HRQL ) and sense of coherence ( SOC ) in psychologically distressed primary care patients .
METHODS	Patients who had participated in an open , pragmatic randomized controlled trial were followed up six months after treatment .
METHODS	The study sample consisted of 120 adults ( 40 per treatment arm ) aged 20 to 55years referred from four different primary health care centres in western Sweden for psychological distress .
METHODS	Assessments were made at baseline after eight weeks and after 24weeks .
METHODS	Anxiety and depression were evaluated with the Hospital Anxiety and Depression scale ( HADS ) , HRQL with the SF-36 Mental Component Summary scores ( MCS ) and SOC with the Sense of Coherence-13 questionnaire .
RESULTS	No baseline differences were found between groups on any outcome variable .
RESULTS	At 24weeks , IT and TA had significantly better values than CT on all variables .
RESULTS	All three groups showed significant improvements from baseline on all variables , except HAD depression in CT ; however , improvements were significantly greater in IT and TA than in CT. .
RESULTS	IT and TA did not differ on any outcome variable .
RESULTS	Effect sizes were large in IT and TA for all variables and small or moderate in CT. .
RESULTS	Improvements on all variables seen after 8-weeks of IT and TA remained stable at 24weeks and the CT group improved on HAD anxiety .
CONCLUSIONS	IT and TA seem to be more beneficial than CT in reducing anxiety , depression , and in improving quality of life and sense of coherence after 24weeks of follow up in patients with psychological distress .
CONCLUSIONS	More research is needed to confirm these results .
BACKGROUND	ISRCTN trial number NCT01631500 .

###25082595
OBJECTIVE	The objective of the study is to determine the efficacy of oral granisetron ( a long-acting 5-HT3 receptor antagonist ) in stopping vomiting subsequent to discharge from emergency department ( ED ) , in 6-month-old to 8-year-old patients with gastroenteritis-related vomiting and dehydration , who had failed an initial trial of oral rehydration ( ORT ) .
METHODS	Eligible patients were offered ORT on a slowly advancing schedule .
METHODS	Patients who tolerated the initial ORT were discharged home .
METHODS	Patients who vomited were randomized to receive either 40 g/kg of granisetron or placebo , and ORT was resumed .
METHODS	Patients who tolerated the postrandomization ORT were discharged home with another dose of the study drug .
METHODS	Parents were contacted by telephone every 24 hours until complete resolution of symptoms .
METHODS	The primary outcome was the proportion of patients with vomiting at 24 hours .
RESULTS	Of the 900 eligible patients , 537 ( 60 % ) tolerated the initial ORT and were discharged home .
RESULTS	Of the patients who vomited during the initial ORT , 165 were included in the final study sample ( placebo , n = 82 ; granisetron , n = 83 ) .
RESULTS	There was no statistically significant difference in the proportion of patients with vomiting at 24 hours ( granisetron , n = 38 ; placebo , n = 45 ; odds ratio , 0.64 ; 95 % confidence interval , 0.34-1 .19 ; P = .16 ) .
RESULTS	A similar trend in the proportion of patients with vomiting was noted for the entire follow-up period ( granisetron , n = 43 ; placebo , n = 47 ; odds ratio , 0.73 ; P = .33 ; 95 % confidence interval , 0.39-1 .36 ) .
CONCLUSIONS	Granisetron was not effective in controlling gastroenteritis-related vomiting subsequent to discharge from ED .
CONCLUSIONS	It did not change the expected course of the illness .

###25406226
BACKGROUND	Although many Latinos in the United States smoke , they receive assistance to quit less often than non-Latinos .
BACKGROUND	To address this disparity , we recruited Latino couples into a randomized controlled trial and provided a smoking cessation program during a teachable moment , when men 's partners were pregnant .
METHODS	We compared two interventions : ( i ) written materials plus nicotine replacement therapy ( NRT ) to ( ii ) materials , NRT , and couple-based counseling that addressed smoking cessation and couples communication .
METHODS	We recruited 348 expectant fathers who smoked via their pregnant partners from county health departments .
METHODS	Our primary outcome was 7-day point prevalence smoking abstinence and was collected from November 2010 through April 2013 and analyzed in February 2014 .
RESULTS	We found high rates of cessation but no arm differences in smoking rates at the end of pregnancy ( 0.31 vs. 0.30 , materials only vs. counseling , respectively ) and 12 months after randomization ( postpartum : 0.39 vs. 0.38 ) .
RESULTS	We found high quit rates among nondaily smokers but no arm differences ( 0.43 vs. 0.46 in pregnancy and 0.52 vs. 0.48 postpartum ) .
RESULTS	Among daily smokers , we found lower quit rates with no arm differences but effects favoring the intervention arm ( 0.13 vs. 0.16 in pregnancy and 0.17 vs. 0.24 postpartum ) .
CONCLUSIONS	A less intensive intervention promoted cessation equal to more intensive counseling .
CONCLUSIONS	Postpartum might be a more powerful time to promote cessation among Latino men .
CONCLUSIONS	Less intensive interventions when delivered during teachable moments for Latino men could result in a high smoking cessation rate and could reduce disparities .

###24756739
BACKGROUND	With ageing , the ability to mobilize fat is reduced and this , coupled with gradual decrease in lean body mass ( LBM ) from lessened exercise , allows for an increased body fat percentage ( % BF ) .
BACKGROUND	Exercising is considered a key to maintaining an appropriate body mass ( BM ) , as it improves fat oxidation , while maintaining LBM .
BACKGROUND	Although the effects of endurance and/or resistance training on fat mass ( FM ) and LBM in the elderly have well been established , limited data are forthcoming regarding the effects of Pilates as a training modality on these variables in the elderly .
OBJECTIVE	The present study was therefore conducted to determine the effects of a mat Pilates programme on body fat in elderly women .
METHODS	Fifty sedentary , apparently healthy females aged 60 years and older were randomly assigned a control ( CG , n = 25 ) or an intervention ( IG , n = 25 ) group .
METHODS	The IG took part in an eight-week progressive mat Pilates exercise programme , three times weekly while the CG were instructed to maintain their normal daily activities throughout the eight-week experimental period .
METHODS	All subjects underwent pre - and post-test in which FM and LBM were assessed .
RESULTS	Eight weeks of mat Pilates demonstrated a significant ( p 0.05 ) decrease in % BF ( p = 0.016 ) and FM ( p = 0.038 ) , with a significant increase in LBM ( p = 0.006 ) , while not showing any significant changes ( p 0.05 ) in BM ( p = 0.979 ) and BMI ( p = 0.992 ) .
RESULTS	The CG , however , did not produce any significant ( p 0.05 ) changes in any of the tested anthropometric variables ( BM : p = 0.266 ; BMI : p = 0.123 ; % BF : p = 0.516 ; FM : p = 0.937 and LBM : p = 0.522 ) after completion of the eight-week Pilates programme .
CONCLUSIONS	An eight-week mat Pilates exercise programme may contradict or even reverse some of the most serious consequences of ageing associated with an increased fat mass and reduced lean body mass in elderly females .

###25135030
BACKGROUND	From an orthopedic point of view , wearing conventional ready to wear shoes negatively affects the front transverse arch of the human foot by forcing it into an unnatural inverted position .
OBJECTIVE	The aim of the present orthopedic application study was to conduct a standardized assessment of the biomechanical effect of a newly developed , longitudinally flexible and cross stable spring steel insole by means of pedobarographic measurements and by means of a supplementary questioning of the participants .
METHODS	In order to do this a total of 33 healthy adult participants were recruited in summer 2013 .
METHODS	The randomized , blinded and controlled main study compared the cross stable insole made from spring steel with a flat , ordinary control insole made from ethylene vinyl acetate by means of pedobarographic in-shoe measurements at the forefoot .
METHODS	Additionally , the subjectively perceived effect of the steel insole with respect to comfort , restricted mobility and pain was assessed in a randomized , blinded and controlled ancillary study , using a cross-over design .
RESULTS	Both the plantar peak pressure and the plantar force-time integral were significantly higher with the spring steel insole , especially in the central forefoot .
RESULTS	In the subsequent test phase lasting several weeks during which the participants were asked to wear the spring steel insole , they rarely complained about problems and in particular did not report negative effects regarding comfort , restricted mobility and pain compared to the ordinary control insoles .
CONCLUSIONS	The present study was conducted according to high methodological standards and proved for the first time that the tested spring steel insoles have a positive effect on the human forefoot .
CONCLUSIONS	The cross stability increases the pressure in the median ball area , prevents the unnatural inverted position of the forefoot and thus creating an effect which is comparable to walking barefoot .
CONCLUSIONS	As the participants did not judge this orthopedic effect of the cross stability as being uncomfortable , such an insole could be used a millionfold as a primary prevention in conventional shoes .

###25264948
OBJECTIVE	The standard recommended dose ( 0.1 U/kg per hour ) of insulin in diabetic ketoacidosis ( DKA ) guidelines is not backed by strong clinical evidence .
OBJECTIVE	Physiologic dose-effect studies have found that even lower doses could adequately normalize ketonemia and acidosis .
OBJECTIVE	Lowering the insulin dose may be advantageous in the initial hours of therapy when a gradual decrease in glucose , electrolytes , and resultant osmolality is desired .
OBJECTIVE	To compare the efficacy and safety of low-dose insulin against the standard dose in children with DKA .
METHODS	This was a prospective , open-label randomized clinical trial conducted in the pediatric emergency department and intensive care unit of a tertiary care teaching hospital in northern India from November 1 , 2011 , through December 31 , 2012 .
METHODS	A total of 50 consecutive children 12 years or younger with a diagnosis of DKA were randomized to low-dose ( n = 25 ) and standard-dose ( n = 25 ) groups .
METHODS	Low-dose ( 0.05 U/kg per hour ) vs standard-dose ( 0.1 U/kg per hour ) insulin infusion .
METHODS	The primary outcome was the rate of decrease in blood glucose until a level of 250 mg/dL or less is reached ( to convert to millimoles per liter , multiply by 0.0555 ) .
METHODS	The secondary outcomes included time to resolution of acidosis , episodes of treatment failures , and incidences of hypokalemia and hypoglycemia .
RESULTS	The mean ( SD ) rate of blood glucose decrease until a level of 250 mg/dL or less is reached ( 45.1 [ 17.6 ] vs 52.2 [ 23.4 ] mg/dL/h ) and the mean ( SD ) time taken to achieve this target ( 6.0 [ 3.3 ] vs 6.2 [ 2.2 ] hours ) were similar in the low - and standard-dose groups , respectively .
RESULTS	Mean ( SD ) length of time to achieve resolution of acidosis ( low vs standard dose : 16.5 [ 7.2 ] vs 17.2 [ 7.7 ] hours ; P = .73 ) and rate of resolution of acidosis were also similar in the groups .
RESULTS	Hypokalemia was seen in 12 children ( 48 % ) receiving the standard dose vs 5 ( 20 % ) of those receiving the low dose ( P = .07 ) ; the tendency was more pronounced in malnourished children ( 7 [ 88 % ] vs 2 [ 28 % ] ) .
RESULTS	Five children ( 20 % ) and 1 child ( 4 % ) receiving standard - and low-dose infusion ( P = .17 ) , respectively , developed hypoglycemia .
RESULTS	Treatment failure was rare and comparable .
RESULTS	One child in the standard-dose group developed cerebral edema , and no deaths occurred during the study period .
CONCLUSIONS	Low dose is noninferior to standard dose with respect to rate of blood glucose decrease and resolution of acidosis .
CONCLUSIONS	We advocate a superiority trial with a larger sample size before 0.05 U/kg per hour replaces 0.1 U/kg per hour in the practice recommendations .
BACKGROUND	ctri.nic.in Identifier : CTRI/2012/04 / 002548 .

###24885993
BACKGROUND	Mosquito coils are the most commonly used household insecticidal product in the world with sales exceeding 50 billion coils , used by two billion people worldwide annually .
BACKGROUND	Despite strong evidence that coils prevent mosquito bites a systematic review concluded that there is no evidence that burning mosquito coils prevents malaria acquisition .
BACKGROUND	Therefore , the current trial was designed to measure and compare prevention of malaria infection by mosquito coils or long-lasting insecticidal net ( LLIN ) or a combination of the two in Yunnan , China in the Greater Mekong sub-region .
METHODS	A four-arm single blind household-randomized design was chosen as coils emanate insecticide throughout the household .
METHODS	Households enrolled at baseline were randomly allocated by the lottery method to one of the four intervention arms : ( i ) nothing , ( ii ) 0.03 % transfluthrin coils alone , ( iii ) deltamethrin long-lasting insecticide treated nets , ( LLINs ) alone or ( iv ) a combination of transfluthrin coils and deltamethrin LLINs .
METHODS	All household members were recruited to the study , with only those households excluded with pregnant or breastfeeding mothers , members with chest complaints or allergies or members that regularly slept away from home .
METHODS	The main outcome of interest was Plasmodium falciparum malaria prevalence detected by rapid diagnostic tests ( RDTs ) during six repeated monthly cross-sectional surveys .
METHODS	The secondary outcome of interest was the effect on Plasmodium vivax prevalence detected in the same way .
RESULTS	A total of 2,052 households were recruited into the study , comprising 7,341 individuals The odds ratios of testing positive by RDT with P. falciparum or P. vivax were > 75 % lower for all intervention arms compared with the control arm .
RESULTS	Coils alone provided 77 % protection ( 95 % CI : 50 % -89 % ) , LLINs provided 91 % protection ( 95 % CI : 72 % -97 % ) and the combination of coils and LLINs provided 94 % protection ( 95 % CI : 77 % -99 % ) against P. falciparum compared with the control arm .
RESULTS	There was no statistically significant difference between the protective efficacies of the different interventions .
CONCLUSIONS	This is the first robust clinical evaluation of transfluthrin mosquito coils as a means to reduce malaria and the high degree of infection prevented would indicate they represent a potentially highly effective tool , which could be integrated into larger vector control programmes .
BACKGROUND	ClinicalTrials.gov Identifier : NCT00442442 , March 2007 .

###25412669
BACKGROUND	Postoperative gastrointestinal dysfunction ( PGD ) is one of the most common complications following major surgeries under general anesthesia ( GA ) .
BACKGROUND	Despite ongoing research and new drug treatments , abdominal distension within 24 h postoperatively occurs in 8 % -28 % of all surgeries .
BACKGROUND	We aim to analyze the effectiveness of preventing PGD by preoperatively stimulating Neiguan ( PC6 ) , Zusanli ( ST36 ) and Shangjuxu ( ST37 ) bilaterally twice a day compared with sham-acupuncture treatment and standard treatment .
METHODS	This is a single-center , prospective practical randomized controlled trial .
METHODS	All groups will be given standard treatments .
METHODS	Patients undergoing vascular surgery under GA will be included from the Vascular Surgery Unit in West China Hospital of Sichuan University , China , and divided into three groups .
METHODS	The experimental group will receive routine treatments and acupuncture at PC6 , ST36 and ST37 bilaterally with electrical stimulation twice a day for 20 min preoperatively .
METHODS	The sham-acupuncture group will receive pseudo-electroacupuncture at sham acupoints of PC6 , ST36 and ST37 , which are 1 cun away from the real acupoints .
METHODS	The routine-treatment group will not receive electroacupuncture .
METHODS	The outcomes include the incidence of abdominal distention , abdominal circumference , the degree of abdominal distension , the first time of flatus and defecation , and hospitalization duration .
CONCLUSIONS	The results from this study will demonstrate whether preoperative electroacupuncture is an effective method for the prevention of PGD in patients undergoing vascular surgery under GA. .
CONCLUSIONS	This study may also provide a standardized acupuncture treatment for reduction of PGD .

###25131184
BACKGROUND	Factors influencing prostate-specific antigen ( PSA ) changes in men undergoing testosterone ( T ) therapy have not been well studied .
OBJECTIVE	The aim of this study was to assess the influence of selected variables on PSA changes in hypogonadal men administered with 1.62 % testosterone gel ( T-gel ) for 6 months .
METHODS	A double-blind , placebo-controlled study of 274 ( 234 T-gel , 40 placebo ) hypogonadal men > 18 years of age , with baseline T concentrations < 300ng/dL , PSA2 .5 ng/mL , and negative digital rectal examination .
METHODS	Subjects received once-daily T-gel for T therapy .
METHODS	Changes in mean serum PSA , percentage of free PSA ( % fPSA ) , and T from baseline to 6 months ( 182 days ) .
RESULTS	Mean age was 53.5 years and baseline mean values were total T 247ng/dL , PSA 0.9 ng/mL , and % fPSA 24.6 % .
RESULTS	Among men treated with T-gel , T increased to 499ng/dL and PSA increased by 0.1 ng/mL ( P = 0.0012 ) .
RESULTS	PSA increased 0.3 ng/mL in 26.3 % , < 0.3 ng/mL in 73.7 % , including a decline from baseline in 33.0 % .
RESULTS	In the placebo group , T increased 29ng/dL to 274ng/dL , and PSA decreased 0.1 ng/mL , compared with baseline .
RESULTS	A greater increase in PSA was noted in men 60 years old than in men < 60 years old ( 0.4 vs. 0.05 ng/mL , respectively ; P = 0.0006 ) .
RESULTS	Mean PSA did not change in men with baseline serum T > 250ng/dL , whereas it increased by 0.2 ng/mL in men with T250ng/dL ( P = 0.0031 ) .
RESULTS	PSA increased 0.3 ng/mL in men with baseline % fPSA < 20 % and 0.1 ng/mL in men with % fPSA20 % .
CONCLUSIONS	Overall , T-gel treatment was associated with a minor increase in PSA , of questionable clinical significance .
CONCLUSIONS	Factors predicting greater PSA increases included age 60 years , baseline T250ng/dL , and % fPSA < 20 % .
CONCLUSIONS	Men with T > 250ng/dL and age < 60 years demonstrated minimal or no PSA change .

###25442659
OBJECTIVE	The objective of the current study was to compare surgeon-rated visualization in shoulder arthroscopy using irrigation fluid with and without epinephrine .
METHODS	Eighty-three patients were randomized to receive irrigation fluid with ( 44 patients ) or without ( 39 patients ) epinephrine during their arthroscopic shoulder procedures .
METHODS	After each procedure , the blinded senior author ( G.F.C. ) evaluated visualization based on a visual analog scale ( VAS ) , and all clinically important procedure variables were recorded .
RESULTS	Eighty-three arthroscopic shoulder procedures were included in the study .
RESULTS	Fifty-four of these procedures were arthroscopic rotator cuff repairs , allowing a subset analysis of this specific procedure .
RESULTS	There was a significant difference , with improved visualization in the epinephrine group versus the group without epinephrine when comparing all procedures ( P < .0001 ) and when comparing only rotator cuff repairs ( P < .0001 ) .
RESULTS	However , there was no statistical difference in other clinically important variables , including operative time and amount of irrigation fluid used .
CONCLUSIONS	The addition of epinephrine to irrigation fluid significantly improves surgeon-rated visualization in shoulder arthroscopy .
CONCLUSIONS	Without an observed significant difference in operative time or volume of irrigation fluid used , the clinical significance of this improved visualization is unclear , and the use of irrigation fluid without epinephrine remains a viable option in the hands of an experienced surgeon .
METHODS	Level I , high-quality randomized controlled trial with statistically significant difference .

###25524333
BACKGROUND	After percutaneous coronary intervention ( PCI ) for non-ST-segment elevation myocardial infarction ( NSTEMI ) , treatment with a P2Y12 antagonist with aspirin is recommended for 1 year .
OBJECTIVE	The oral P2Y12 antagonists ticagrelor and prasugrel have higher recommendations than clopidogrel , but it is unknown if administration before the start of PCI is beneficial .
METHODS	In the randomized , double-blind ACCOAST ( A Comparison of prasugrel at the time of percutaneous Coronary intervention Or as pre-treatment At the time of diagnosis in patients with non-ST-segment elevation myocardial infarction ) trial , 4,033 patients were diagnosed with NSTEMI and 68.7 % underwent PCI ; 1,394 received pre-treatment with prasugrel ( 30-mg loading dose ) , and 1,376 received placebo .
METHODS	At the time of PCI , patients who received pre-treatment with prasugrel received an additional 30-mg dose of prasugrel , and those who received placebo received a 60-mg loading dose of prasugrel .
METHODS	Primary efficacy was a composite of cardiovascular death , myocardial infarction , stroke , urgent revascularization , or glycoprotein IIb/IIIa bailout through 7 days from randomization .
METHODS	Investigators captured the presence of thrombus on initial angiography and during PCI .
RESULTS	The incidence of the primary endpoint through 7 days from randomization in the pre-treatment group versus the no pre-treatment group was 13.1 % versus 13.1 % ( p = 0.93 ) .
RESULTS	Pre-treatment with prasugrel was not associated with decreases in any ischemic event , including total mortality .
RESULTS	Patients with thrombus on angiography had a 3-fold higher incidence of the primary endpoint than patients without thrombus .
RESULTS	There was no impact of pre-treatment with prasugrel on the presence of thrombus before PCI or on occurrence of stent thrombosis after PCI .
RESULTS	There was a 3-fold increase in all non-coronary artery bypass graft Thrombolysis In Myocardial Infarction ( TIMI ) major bleeding and a 6-fold increase in non-coronary artery bypass graft life-threatening bleeding with pre-treatment with prasugrel ; the same trends persisted in patients who had radial or femoral access even with use of a closure device .
CONCLUSIONS	These findings support deferring treatment with prasugrel until a decision is made about revascularization in patients with NSTEMI undergoing angiography within 48 h of admission .
CONCLUSIONS	( A Comparison of prasugrel at the time of percutaneous Coronary intervention Or as pre-treatment At the time of diagnosis in patients with non-ST-segment elevation myocardial infarction [ ACCOAST ] ; NCT01015287 ) .

###24326236
BACKGROUND	High-frequency repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex ( rTMS-DLPFC ) is an effective treatment for depression .
BACKGROUND	Preliminary studies indicated beneficial effects of rTMS-DLPFC on pain relief in patients treated for depression , and in patients with chronic migraine .
METHODS	In this randomized , double-blind , parallel-group , single-center , proof-of-principle clinical trial , we tested the hypothesis that 23 sessions of active rTMS-DLPFC delivered over eight weeks would be feasible , safe and superior to sham rTMS to decrease the number of headache days in 18 patients with chronic migraine without severe depression .
METHODS	Per-protocol analysis was performed .
RESULTS	rTMS-DLPFC applied over eight weeks was feasible and safe in patients with chronic migraine .
RESULTS	Contrary to our primary hypothesis , the number of headache days decreased significantly more in the sham group than in the group treated with active rTMS-DLPFC at eight weeks .
RESULTS	Average decrease in headache days was > 50 % in the sham group , indicating a powerful placebo response .
RESULTS	Pain intensity improved in both groups to a similar extent .
CONCLUSIONS	Positive results of M1 stimulation in other studies , and the absence of significant benefits of active high-frequency rTMS of the DLPFC in the present study , point to M1 as a more promising target than the DLPFC , for larger trials of noninvasive brain stimulation in patients with chronic migraine .

###24678896
BACKGROUND	Colorectal cancer ( CRC ) is the second most prevalent type of cancer in Europe .
BACKGROUND	A single flexible sigmoidoscopy ( FS ) screening at around the age of 60 years prevents about one-third of CRC cases .
BACKGROUND	However , FS screens only the distal colon , and thus mortality from proximal CRC is unaffected .
BACKGROUND	Computed tomography colonography ( CTC ) is a highly accurate examination that allows assessment of the entire colon .
BACKGROUND	However , the benefit of CTC testing as a CRC screening test is uncertain .
BACKGROUND	We designed a randomized trial to compare participation rate , detection rates , and costs between CTC ( with computer-aided detection ) and FS as primary tests for population-based screening .
METHODS	An invitation letter to participate in a randomized screening trial comparing CTC versus FS will be mailed to a sample of 20,000 people aged 58 or 60 years , living in the Piedmont region and the Verona district of Italy .
METHODS	Individuals with a history of CRC , adenomas , inflammatory bowel disease , or recent colonoscopy , or with two first-degree relatives with CRC will be excluded from the study by their general practitioners .
METHODS	Individuals responding positively to the invitation letter will be then randomized to the intervention group ( CTC ) or control group ( FS ) , and scheduled for the screening procedure .
METHODS	The primary outcome parameter of this part of the trial is the difference in advanced neoplasia detection between the two screening tests .
METHODS	Secondary outcomes are cost-effectiveness analysis , referral rates for colonoscopy induced by CTC versus FS , and the expected and perceived burden of the procedures .
METHODS	To compare participation rates for CTC versus FS , 2,000 additional eligible subjects will be randomly assigned to receive an invitation for screening with CTC or FS .
METHODS	In the CTC arm , non-responders will be offered fecal occult blood test ( FOBT ) as alternative screening test , while in the FS arm , non-responders will receive an invitation letter to undergo screening with either FOBT or CTC .
METHODS	Data on reasons for participation and non-participation will also be collected .
CONCLUSIONS	This study will provide reliable information concerning benefits and risks of the adoption of CTC as a mass screening intervention in comparison with FS .
CONCLUSIONS	The trial will also evaluate the role of computer-aided detection in a screening setting .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01739608 .

###26001028
BACKGROUND	Awake regional anesthesia ( RA ) is a viable alternative to general anesthesia ( GA ) for infants undergoing lower abdominal surgery .
BACKGROUND	Benefits include lower incidence of postoperative apnea and avoidance of anesthetic agents that may increase neuroapoptosis and worsen neurocognitive outcomes .
BACKGROUND	The General Anesthesia compared to Spinal anesthesia study compares neurodevelopmental outcomes after awake RA or GA in otherwise healthy infants .
BACKGROUND	The aim of the study is to describe success and failure rates of RA and report factors associated with failure .
METHODS	This was a nested cohort study within a prospective , randomized , controlled , observer-blind , equivalence trial .
METHODS	Seven hundred twenty-two infants 60 weeks or less postmenstrual age scheduled for herniorrhaphy under anesthesia were randomly assigned to receive RA ( spinal , caudal epidural , or combined spinal caudal anesthetic ) or GA with sevoflurane .
METHODS	The data of 339 infants , where spinal or combined spinal caudal anesthetic was attempted , were analyzed .
METHODS	Possible predictors of failure were assessed including patient factors , technique , experience of site and anesthetist , and type of local anesthetic .
RESULTS	RA was sufficient for the completion of surgery in 83.2 % of patients .
RESULTS	Spinal anesthesia was successful in 86.9 % of cases and combined spinal caudal anesthetic in 76.1 % .
RESULTS	Thirty-four patients required conversion to GA , and an additional 23 patients ( 6.8 % ) required brief sedation .
RESULTS	Bloody tap on the first attempt at lumbar puncture was the only risk factor significantly associated with block failure ( odds ratio = 2.46 ) .
CONCLUSIONS	The failure rate of spinal anesthesia was low .
CONCLUSIONS	Variability in application of combined spinal caudal anesthetic limited attempts to compare the success of this technique to spinal alone .

###24486242
OBJECTIVE	To compare a multicomponent motivational interviewing ( MI ) / self-management ( SM ) intervention with a multicomponent education intervention to improve skin-protective behaviors and prevent skin worsening in veterans with spinal cord injury ( SCI ) hospitalized for severe pressure ulcers ( PrUs ) .
METHODS	Single-blinded , prospective , randomized controlled trial .
METHODS	Six Veterans Affairs SCI centers .
METHODS	Veterans admitted for a severe ( stage III/IV ) PrU were followed up to 6 months postdischarge .
METHODS	Telephone-based individual MI counseling plus SM skills group ( SM+MI ; n = 71 ) versus an active control group of telephone-based individual educational counseling plus group education ( n = 72 ) .
METHODS	Self-reported skin-protective behaviors , objective skin worsening .
RESULTS	Intention-to-treat analyses found nonsignificant increases in skin behaviors in the SM+MI versus education control intervention arms at 3 and 6 months .
RESULTS	The difference in behaviors used between SM+MI and education control intervention participants was 4.6 % ( 95 % confidence interval [ CI ] , -11.3 to 2.7 ) ( 0-3mo ) and 3.0 % ( 95 % CI , -8.7 to 3.9 ) ( 0-6mo ) .
RESULTS	High rates of skin worsening were observed ( n = 74 , 51.7 % ) , usually within 3 months postdischarge and most frequently within the month postdischarge .
RESULTS	Skin worsening , skin-related visits , and readmissions did not differ by study arm .
RESULTS	Study limitations are presented .
CONCLUSIONS	For persons with chronic SCI and severe PrUs , complicated by multiple comorbidities , a primary focus on improving patient behavior is likely insufficient to address the complex problem of PrUs in SCI .
CONCLUSIONS	More health care systems-level changes such as collaborative care may be needed to reduce PrU recurrence , especially in this era in which many people are discharged from the hospital unhealed or with little sitting tolerance .

###25701170
BACKGROUND	Orteronel is an investigational , partially selective inhibitor of CYP 17,20-lyase in the androgen signalling pathway , a validated therapeutic target for metastatic castration-resistant prostate cancer .
BACKGROUND	We assessed orteronel in chemotherapy-naive patients with metastatic castration-resistant prostate cancer .
METHODS	In this phase 3 , double-blind , placebo-controlled trial , we recruited patients with progressive metastatic castration-resistant prostate cancer and no previous chemotherapy from 324 study centres ( ie , hospitals or large urologic or group outpatient offices ) in 43 countries .
METHODS	Eligible patients were randomly assigned in a 1:1 ratio to receive either 400 mg orteronel plus 5 mg prednisone twice daily or placebo plus 5 mg prednisone twice daily .
METHODS	Randomisation was done centrally with an interactive voice response system and patients were stratified by region ( Europe , North America , and not Europe or North America ) and the presence or absence of radiographic disease progression at baseline .
METHODS	The two primary endpoints were radiographic progression-free survival and overall survival , determined in the intention-to-treat population .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01193244 .
RESULTS	From Oct 31 , 2010 , to June 29 , 2012 , 2353 patients were assessed for eligibility .
RESULTS	Of those , 1560 were randomly assigned to receive either orteronel plus prednisone ( n = 781 ) or placebo plus prednisone ( n = 779 ) .
RESULTS	The clinical cutoff date for the final analysis was Jan 15 , 2014 ( with 611 deaths ) .
RESULTS	Median follow-up for radiographic progression-free survival was 84 months ( IQR 37-166 ) .
RESULTS	Median radiographic progression-free survival was 138 months ( 95 % CI 131-149 ) with orteronel plus prednisone and 87 months ( 83-109 ) with placebo plus prednisone ( hazard ratio [ HR ] 071 , 95 % CI 063-080 ; p < 00001 ) .
RESULTS	After a median follow-up of 207 months ( IQR 142-254 ) , median overall survival was 314 months ( 95 % CI 286-not estimable ) with orteronel plus prednisone and 295 months ( 270-not estimable ) with placebo plus prednisone ( HR 092 , 95 % CI 079-108 ; p = 031 ) .
RESULTS	The most common grade 3 or worse adverse events were increased lipase ( 137 [ 17 % ] of 784 patients in the orteronel plus prednisone group vs 14 [ 2 % ] of 770 patients in the placebo plus prednisone group ) , increased amylase ( 77 [ 10 % ] vs nine [ 1 % ] ) , fatigue ( 50 [ 6 % ] vs 14 [ 2 % ] ) , and pulmonary embolism ( 40 [ 5 % ] vs 27 [ 4 % ] ) .
RESULTS	Serious adverse events were reported in 358 [ 46 % ] patients receiving orteronel plus prednisone and in 292 [ 38 % ] patients receiving placebo plus prednisone .
CONCLUSIONS	In chemotherapy-naive patients with metastatic castration-resistant prostate cancer , radiographic progression-free survival was prolonged with orteronel plus prednisone versus placebo plus prednisone .
CONCLUSIONS	However , no improvement was noted in the other primary endpoint , overall survival .
CONCLUSIONS	Orteronel plus prednisone was associated with increased toxic effects compared with placebo plus prednisone .
CONCLUSIONS	On the basis of these and other data , orteronel is not undergoing further development in metastatic castration-resistant prostate cancer .
BACKGROUND	Millennium Pharmaceuticals , Inc , a wholly owned subsidiary of Takeda Pharmaceutical Company Limited .

###24424707
BACKGROUND	Vortioxetine is a recently approved multimodal antidepressant with anxiolytic properties in preclinical studies .
OBJECTIVE	This double-blind , placebo-controlled study assessed the efficacy and tolerability of vortioxetine in subjects with a primary diagnosis of generalized anxiety disorder .
METHODS	Subjects ( n = 457 ) were randomized 1:1:1 to treatment with placebo or vortioxetine 2.5 or 10mg once daily .
METHODS	The primary efficacy endpoint was reduction in Hamilton Anxiety Scale ( HAM-A ) total scores from baseline after 8weeks of treatment .
METHODS	Key secondary outcomes were changes from baseline in HAM-A total scores for the 2.5 and 10mg dose , Hospital Anxiety and Depression anxiety subscore , 36-Item Short-Form Health Survey , Sheehan Disability Scale , and Clinical Global Impression-Improvement Scale score , as well as HAM-A response rate at week 8 .
RESULTS	Neither vortioxetine dose achieved a statistically significant improvement over placebo on the primary endpoint ( least-squares mean differencestandard error from placebo : -0.870.803 [ p = 0.279 ] for 2.5 mg and -0.810.791 [ p = 0.306 ] for 10mg vortioxetine ) or on any secondary efficacy endpoints .
RESULTS	Common adverse events ( 5 % in either vortioxetine group ) were nausea , dry mouth , headache , diarrhea , constipation , and vomiting .
CONCLUSIONS	Vortioxetine 2.5 and 10mg treatment did not significantly improve generalized anxiety disorder symptoms versus placebo .
CONCLUSIONS	Vortioxetine was safe and well tolerated in this patient population .

###24444117
BACKGROUND	In acute stroke , the volume of salvageable brain tissue is maximal at onset and declines rapidly with time .
BACKGROUND	Prehospital start of clinical trial interventions would enable delivery of neuroprotective agents , such as magnesium sulfate , to stroke patients in the hyperacute period when they are potentially most effective .
OBJECTIVE	A broad aim of the FAST-MAG study is to develop and validate techniques to perform pivotal trials of neuroprotective therapies for acute stroke in the prehospital setting .
OBJECTIVE	In tandem with an accompanying general trial design article , this manuscript provides a detailed overview of several novel prehospital study methods employed in the NIH FAST-MAG Trial .
METHODS	Multicenter , randomized , double-blinded , placebo-controlled , pivotal clinical trial .
METHODS	Special Prehospital Procedures Distinctive prehospital methods deployed in FAST-MAG include : identifying likely stroke patients using the Los Angeles Prehospital Stroke Screen ; eliciting explicit informed consent from patients or on scene legally authorized representatives via cellphone discussion with off-scene physicians ; paramedic rating of pretreatment stroke severity using the Los Angeles Motor Scale ; assigning patients to a study arm using blinded , pre-encounter randomization ; facilitating continuity of study infusion from the field to the ED by stocking ambulances with study kits including both field and hospital doses ; and electronic fax consent signature documentation by geographically separated subjects and enrolling physicians .
CONCLUSIONS	The suite of prehospital trial methods developed for the FAST-MAG Trial enable enrollment of patients in very early time windows , including the hyperacute , ` golden hour ' period immediately after stroke onset .

###24722493
OBJECTIVE	The development of periarticular thickening of skin on the hands and limited joint mobility ( cheiroarthropathy ) is associated with diabetes and can lead to significant disability .
OBJECTIVE	The objective of this study was to describe the prevalence of cheiroarthropathy in the well-characterized Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications ( DCCT/EDIC ) cohort and examine associated risk factors , microvascular complications , and the effect of former DCCT therapy ( intensive [ INT ] vs. conventional [ CONV ] ) on its development .
METHODS	This cross-sectional analysis was performed in 1,217 participants ( 95 % of the active cohort ) in EDIC years 18/19 after an average of 24 years of follow-up .
METHODS	Cheiroarthropathy-defined as the presence of any one of the following : adhesive capsulitis , carpal tunnel syndrome , flexor tenosynovitis , Dupuytren 's contracture , or a positive prayer sign-was assessed using a targeted medical history and standardized physical examination .
METHODS	A self-administered questionnaire ( Disabilities of the Arm , Shoulder and Hand [ DASH ] ) assessed functional disability .
RESULTS	Cheiroarthropathy was present in 66 % of subjects ( 64 % of the INT group and 68 % of the CONV group ; P = 0.1640 ) and was associated with age , sex , diabetes duration , skin intrinsic fluorescence , HbA1c , neuropathy , and retinopathy ( P < 0.005 for each ) .
RESULTS	DASH functional disability scores were worse among subjects with cheiroarthropathy ( P < 0.0001 ) .
CONCLUSIONS	Cheiroarthropathy is common in people with type 1 diabetes of long duration ( 30 years ) and is related to longer duration and higher levels of glycemia .
CONCLUSIONS	Clinicians should include cheiroarthropathy in their routine history and physical examination of patients with type 1 diabetes because it causes clinically significant functional disability .

###24361312
OBJECTIVE	The present research examined the effects of a mindfulness-based intervention to foster healthy eating .
OBJECTIVE	Specifically , we tested whether a brief mindfulness manipulation can prevent the portion size effect , and reduce overeating on unhealthy snacks when hungry .
METHODS	110 undergraduate participants ( MAge = 20.92.3 ; MBMI = 22.32.5 ) were served a small or a large portion of chocolate chip cookies after listening to an audio book or performing a mindfulness exercise ( i.e. , body scan ) .
METHODS	Current level of hunger was assessed unobtrusively on a visual analog scale before the eating situation .
METHODS	Calorie intake from chocolate chip cookies .
RESULTS	When presented with a large compared to a small portion , participants consumed more cookies ( +83 kcal ) .
RESULTS	This was not affected by the mindfulness intervention or by hunger .
RESULTS	However , while control participants ate more unhealthy food when hungry than when not hungry ( +67 kcal ) , participants in the mindfulness condition did not ( +1 kcal ) .
CONCLUSIONS	Findings confirm the prevalence and robustness of the portion size effect and suggest that it may be independent from awareness of internal cues .
CONCLUSIONS	Prevention strategies may benefit more from targeting awareness of the external environment .
CONCLUSIONS	However , mindfulness-based interventions may be effective to reduce effects of hunger on unhealthy food consumption .

###25450275
OBJECTIVE	This study aimed to investigate the potential use of icotinib as first-line treatment to prevent brain metastasis from advanced lung adenocarcinoma .
METHODS	This investigation was designed as a retrospective nonrandomized controlled study .
METHODS	Enrolled patients received either icotinib or traditional chemotherapy as their first-line treatment .
METHODS	The therapeutic efficacy was compared among patients with advanced ( stages IIIB and IV ) lung adenocarcinoma with epidermal growth factor receptor ( EGFR ) - sensitive mutation .
METHODS	The primary endpoint was the cumulative incidence of brain metastasis , whereas the secondary endpoint was overall survival ( OS ) .
METHODS	Death without brain metastasis was considered a competitive risk to calculate the cumulative risk of brain metastasis .
METHODS	Survival analysis was conducted using the Kaplan-Meier method and statistical significance were determined using the log-rank test .
RESULTS	The present study included 396 patients with 131 in the icotinib group and 265 in the chemotherapy group .
RESULTS	Among those with EGFR-sensitive mutation , the cumulative risk of brain metastasis was lower in the icotinib group than in the chemotherapy group .
RESULTS	However , no significant difference in OS was observed between the two groups .
CONCLUSIONS	Icotinib can effectively reduce the incidence of brain metastasis and therefore improve prognosis in advanced lung adenocarcinoma patients with EGFR-sensitive mutation .

###24587233
BACKGROUND	Many people with suicidal thoughts do not receive treatment .
BACKGROUND	The Internet can be used to reach more people in need of support .
OBJECTIVE	To test the effectiveness of unguided online self-help to reduce suicidal thoughts .
METHODS	236 adults with mild to moderate suicidal thoughts were randomised to the intervention ( n = 116 ) or a waitlist control group ( n = 120 ) .
METHODS	Assessments took place at baseline , and 2 , 4 and 6 weeks later .
METHODS	Primary outcome was suicidal thoughts .
METHODS	Secondary outcomes were depressive symptoms , anxiety , hopelessness , worry , and health status .
RESULTS	The intervention group showed a small significant effect in reducing suicidal thoughts ( d = 0.28 ) .
RESULTS	Effects were more pronounced for those with a history of repeated suicide attempts .
RESULTS	There was also a significant reduction in worry ( d = 0.33 ) .
RESULTS	All other secondary outcomes showed small but non-significant improvements .
CONCLUSIONS	Although effect sizes were small , the reach of the internet could enable this intervention to help many people reduce their suicidal thoughts .
BACKGROUND	Netherlands Trial Register NTR1689 .

###25027821
BACKGROUND	Matrix metalloproteinase-2 and -9 , known as gelatinases , are considered to be essential for tissue remodelling during the reproductive process .
BACKGROUND	However , their role in reproduction is unclear .
OBJECTIVE	In the present study , we aimed to investigate the relationship between follicular fluid gelatinase levels and oocyte quality and fertilization , and to compare the activities of gelatinase levels with different drug stimulation protocols .
METHODS	We evaluated 60 women with unexplained infertility who underwent in vitro fertilization ( IVF ) treatment .
METHODS	Thirty patients underwent a gonadotropin-releasing hormone ( GnRH ) agonist protocol and 30 underwent a GnRH antagonist protocol .
METHODS	Follicular fluid was obtained during oocyte retrieval .
METHODS	Oocyte quality was determined using light microscopy , and oocytes were considered to be fertilized when two pronuclei were present .
METHODS	Gelatinase activities were measured using commercial enzyme-linked immunosorbent assay kits .
METHODS	The study was partially supported by the Scientific Research Unit of Suleyman Demirel University ( Protocol Number : 3620-TU1-13 ) , and all procedures were conducted with the approval of the Suleyman Demirel University Local Ethics Board .
METHODS	Statistical analyses of the data were performed using the independent t test , Fisher exact test , Mann-Whitney U test , one-way ANOVA , and posthoc least significant difference .
RESULTS	Follicular fluid gelatinase levels were significantly higher for agonist drug administration ( p = 0.001 ) , and a positive correlation was observed between matrix metalloproteinase-9 levels and oocyte grade ( p = 0.01 ) .
RESULTS	Moreover , a positive relationship between matrix metalloproteinase-9 levels and fertilization was observed ( p = 0.02 ) .
CONCLUSIONS	Follicular fluid gelatinase activities , particularly MMP-9 activity , might be a predictor of oocyte quality and IVF success .

###24717908
OBJECTIVE	Remifentanil is an ultrashort-acting synthetic opioid , and the metabolism of which is not influenced by hepatic or renal function .
OBJECTIVE	This study aims to compare the efficacy of two remifentanil doses during procedures in ventilated preterm infants .
METHODS	Prospective , randomized , double-blind , noninferiority trial .
METHODS	Neonatal ICU .
METHODS	Preterm infants who were supported by a mechanical ventilator with tracheal tube and requiring central venous access .
METHODS	Two remifentanil dosages were administered in mechanically ventilated preterm infants during peripherally inserted central catheter insertion .
METHODS	Fourteen preterm infants were randomly assigned to low-dose ( 0.1 g/kg/min ) or high-dose ( 0.25 g/kg/min ) remifentanil infusion .
METHODS	The Premature Infant Pain Profile was used to score pain during the procedure , and changes in the Premature Infant Pain Profile score between needle puncture and baseline were analyzed to investigate the noninferiority of low-dose to high-dose remifentanil .
METHODS	Occurrence of cardiorespiratory complications was also recorded .
RESULTS	The median gestational age ( minimum , maximum ) was 26 weeks ( 24 , 31 ) , and the median birth weight was 825 g ( 610 , 1,280 ) .
RESULTS	Changes in Premature Infant Pain Profile in the high-dose and low-dose groups were 1.43 3.10 and -0.60 5.32 , respectively .
RESULTS	The difference in changes in the Premature Infant Pain Profile score between the high-dose and low-dose groups was -2.03 4.13 .
RESULTS	The corresponding lower limit of one-tailed 97.5 % CI was -7.24 , below the noninferiority margin .
RESULTS	Apneic events and bradycardia did not occur in the low-dose group ; however , there were three episodes of apnea ( 42.9 % ) and one of bradycardia ( 14.3 % ) in the high-dose group ( p = 0.683 and 0.366 , respectively ) .
CONCLUSIONS	For mechanically ventilated preterm infants , the use of remifentanil at 0.25 g/kg/min as an analgesic for short procedures represents a therapeutic option .
CONCLUSIONS	Our pilot study suggests the need for larger randomized trials .

###24720640
OBJECTIVE	The objective of this study was to compare two different periodontal plastic surgery procedures to treat Miller 's class I recession : a coronally advanced flap ( control group ) versus the pouch technique ( test group ) , both of which were associated with connective tissue graft .
METHODS	Forty consecutive patients were included , with 20 patients being allocated for each group .
METHODS	The level of recession coverage , the keratinized tissue ( KT ) quantity , gingival aesthetics ( PES ) and post-operative outcomes were assessed for a follow-up period of 6 months .
RESULTS	After 6 months , both techniques allowed for the excellent mean root coverage of 96.3 plus/minus 12.1 % in the control group and of 91.3 plus/minus 17.6 % in the test group.Complete root coverage was achieved in 89.5 % ( 17/19 ) and 79 % ( 15/19 ) of the recession cases in the control and the test groups respectively .
RESULTS	A significant increase in KT height ( p = 0.0011 ) was observed in the test group .
RESULTS	A significant improvement in the pink aesthetic score was found in the two groups , but gingival texture displayed significantly better results in the test group ( p < 0.0001 ) .
RESULTS	No significant difference between the two groups was found in terms of the morbidity outcomes .
RESULTS	Pain killer consumption was similar in the two groups and significantly decreased over time .
CONCLUSIONS	Both surgical techniques are relevant in treating Miller 's class I recession .
CONCLUSIONS	The pouch technique seems to increase the height of KT better and provides good gingival-related aesthetic outcomes .

###26255512
OBJECTIVE	To explore the effects and mechanism of acupuncture at Zusanli ( ST 36 ) combined with oral administration of Gexia Zhuyu decoction on damp-heat ulcerative colitis at active phase .
METHODS	One hundred and twenty cases of damp-heat ulcerative colitis at active phase , by using random draw method , were divided into an observation group and a control group , 60 cases in each one .
METHODS	Patients in the control group were treated with basic treatment combined with oral administration of Gexia Zhuyu decoction .
METHODS	Based on this , patients in the observation group were additionally treated with acupuncture at Zusanli ( ST 36 ) .
METHODS	The treatment was given both for 14 days .
METHODS	The efficacy , each symptom score , serum interleukin-1beta ( IL-1beta ) , interleukin-6 ( IL-6 ) and tumor necrosis factor-alpha ( TNF-alpha ) were observed .
RESULTS	( 1 ) After treatment , the total effective rate was 98.3 % ( 59/60 ) in the observation group , which was significantly higher than 86.7 % ( 52/60 ) in the control group ( P < 0.05 ) .
RESULTS	( The improvement rates of ulceration , edema , erosion and polyp in the observation group were obviously higher than those in the control group ( all P < 0.05 ) .
RESULTS	( 3 ) After treatment , the symptom scores of diarrhea , bloody purulent stool , abdominal pain , tenesmus as well as inflammatory factors of IL-1beta , IL-6 and TNF-alpha were all improved compared with those before treatment in the two groups ( all P < 0.05 ) ; the differences between the observation , group and control group were statistically significant ( all P < 0.05 ) .
RESULTS	( 4 ) During the 3-month follow up visit , the recurrence rate was 1.7 % ( 1/59 ) in the observation group , which was significantly lower than 11.5 % ( 6/52 ) in the control group ( P < 0.05 ) .
CONCLUSIONS	The Gexia Zhuyu decoction combined with acupuncture at Zusanli ( ST 36 ) could effectively improve efficacy , reduce recurrence rate , relieve clinical symptoms and prompt recovery of mucous membrane in patients with damp-heat ulcerative colitis at active phase , which is related with reducing the expression of inflammation .

###24427796
OBJECTIVE	To compare the incidence and intensity of posterior capsule opacification ( PCO ) between 2 similar 1-piece foldable hydrophobic acrylic intraocular lenses ( IOLs ) over 3 years .
METHODS	Department of Ophthalmology , Medical University Vienna , Vienna , Austria .
METHODS	Randomized prospective patient - and examiner-masked clinical trial with intraindividual comparison .
METHODS	Patients with bilateral age-related cataract had cataract surgery and implantation of a Tecnis ZCB00 continuous-optic-edge IOL in 1 eye and an Acrysof SA60AT interrupted-optic-edge IOL in the other eye .
METHODS	Postoperative examinations were performed at 6 months and 3 years .
METHODS	Digital retroillumination images were taken of each eye .
METHODS	The amount of PCO ( score 0 to 10 ) was assessed subjectively at the slitlamp and objectively using automated image-analysis software .
RESULTS	The study comprised 54 patients ( 108 eyes ) .
RESULTS	The mean objective PCO score was 1.3 1.7 ( SD ) for the continuous-optic-edge IOLs and 0.9 1.3 for the interrupted-optic-edge IOLs ( P = .10 ) .
RESULTS	Three years postoperatively , a neodymium : YAG ( Nd : YAG ) capsulotomy was performed in 26.1 % of eyes with the continuous-optic-edge IOL and 21.7 % with the interrupted-optic-edge IOL ( P = .56 ) .
RESULTS	There was no significant difference in corrected distance visual acuity , capsulorhexisIOL overlap , capsule folds , or anterior capsule opacification 3 years after surgery .
CONCLUSIONS	Both IOLs had comparable PCO and Nd : YAG rates 3 years postoperatively .
CONCLUSIONS	The optimized barrier function of the continuous-optic-edge IOL and the material properties of the interrupted-optic-edge IOL seemingly outbalanced the effect on lens epithelial cell migration and proliferation beneath the optic .

###24331269
OBJECTIVE	To use a cine balanced steady-state free precession magnetic resonance enterography ( cine MRE ) pulse sequence to assess the effectiveness of a sublingual ( SL ) antiperistaltic agent , hyoscyamine sulfate .
METHODS	Institutional review board approval was granted with an exemption for informed consent in this Health Insurance Portability and Accountability Act-compliant , retrospective , single-institution study .
METHODS	Of the 288MRE examinations performed between October 1 , 2007 and January 15 , 2011 , 92 using SL hyoscyamine sulfate for antiperistalsis were included for review , each with cine MRE before and after medication .
METHODS	These 184 cine MRE data sets were randomized , blinded for treatment , and independently reviewed by five attending abdominal radiologists , who rated the degree of whole abdomen bowel motility on each cine MRE data set on a 5-point scale .
METHODS	Pre - and postmedication mean peristalsis ratings , standard deviation , mean difference , and treatment effect sizes werecalculated .
METHODS	A repeated measures analysis of variance test was performed using a significance threshold of P = .05 .
METHODS	Interobserver reliabilities were also calculated .
RESULTS	Mean peristalsis ratings ranged 2.63-3 .34 and 2.36-3 .03 , before and after medication administration , respectively .
RESULTS	The mean differences ranged from 0.22 to 0.46 , which are treatment effect sizes of 0.20 to 0.37 .
RESULTS	The decrease in peristalsis observed by the five reviewing radiologists after SL hyoscyamine sulfate administration was significant ( df = 1/182 , f = 7.35 , P < .01 ) .
RESULTS	The interobserver reliabilities were 0.34 for the pretest and 0.33 for the posttest .
CONCLUSIONS	Although cine MRE sequences show decreased bowel peristalsis after the use of SL hyoscyamine sulfate , the small size ofthe observed treatment effect is likely insufficient to justify its use for MRE .

###24550168
OBJECTIVE	CONCERTO was a randomised , double-blind , parallel-armed study of methotrexate ( MTX ) in combination with adalimumab to assess whether an increasing trend of efficacy and decreased safety exists when increasing MTX dose in patients with early rheumatoid arthritis ( RA ) .
METHODS	Early , biologic and MTX-naive RA patients ( N = 395 ) were evenly randomised to open-label adalimumab ( 40mg every other week ) plus weekly blinded 2.5 , 5 , 10 or 20mg MTX for 26weeks .
METHODS	Clinical , radiographic and functional outcomes were analysed using two-sided linear trend tests or one-way analysis of covariance .
RESULTS	Statistically significant increasing trends were observed in the proportion of patients achieving the primary endpoint , 28-joint count disease activity score with C reactive protein ( DAS28 ( CRP ) ) < 3.2 ( 42.9 % , 44.0 % , 56.6 % and 60.2 % for 2.5 , 5 , 10 or 20mg/week MTX , respectively ) , DAS28 ( CRP ) < 2.6 and American College of Rheumatology 50/70/90 responses with increasing doses of MTX in combination with adalimumab .
RESULTS	No statistical differences in minimal clinically important differences in physical function were detected .
RESULTS	Statistically significant trends for achieving low disease activity and remission were demonstrated with increasing MTX dose by validated clinical indices ; differences comparing 10 and 20mg MTX were minimal .
RESULTS	Adalimumab serum concentrations increased with ascending dose up to 10mg MTX .
RESULTS	More patients experienced infectious adverse events with increasing MTX dose .
CONCLUSIONS	Increasing doses of MTX in combination with adalimumab demonstrated a statistically significant trend in improved clinical outcomes that mimicked the adalimumab pharmacokinetic profile .
CONCLUSIONS	In early RA patients initiating adalimumab combination therapy , efficacy of 10 and 20mg/week MTX appeared equivalent .

###25754458
OBJECTIVE	To compare transvaginal prolapse repair combined with midurethral sling ( MUS ) versus prolapse repair only .
METHODS	Multi-centre randomised trial .
METHODS	Fourteen teaching hospitals in the Netherlands .
METHODS	Women with symptomatic stage two or greater pelvic organ prolapse ( POP ) , and subjective or objective stress urinary incontinence ( SUI ) without prolapse reduction .
METHODS	Women were randomly assigned to undergo vaginal prolapse repair with or without MUS .
METHODS	Analysis was according to intention to treat .
METHODS	The primary outcome at 12 months ' follow-up was the absence of urinary incontinence ( UI ) assessed with the Urogenital Distress Inventory and treatment for SUI or overactive bladder .
METHODS	Secondary outcomes included complications .
RESULTS	One hundred and thirty-four women were analysed at 12 months ' follow-up ( 63 in MUS and 71 in control group ) .
RESULTS	More women in the MUS group reported the absence of UI and SUI ; respectively 62 % versus 30 % UI ( relative risk [ RR ] 2.09 ; 95 % confidence interval [ CI ] 1.39-3 .15 ) and 78 % versus 39 % SUI ( RR 1.97 ; 95 % CI 1.44-2 .71 ) .
RESULTS	Fewer women underwent treatment for postoperative SUI in the MUS group ( 10 % versus 37 % ; RR 0.26 ; 95 % CI 0.11-0 .59 ) .
RESULTS	In the control group , 12 women ( 17 % ) underwent MUS after prolapse surgery versus none in the MUS group .
RESULTS	Severe complications were more common in the MUS group , but the difference was not statistically significant ( 16 % versus 6 % ; RR 2.82 ; 95 % CI 0.93-8 .54 ) .
CONCLUSIONS	Women with prolapse and co-existing SUI are less likely to have SUI after transvaginal prolapse repair with MUS compared with prolapse repair only .
CONCLUSIONS	However , only 17 % of the women undergoing POP surgery needed additional MUS .
CONCLUSIONS	A well-informed decision balancing risks and benefits of both strategies should be tailored to individual women .

###25137875
OBJECTIVE	To compare the postprandial plasma glucose level after diabetic specific formula ( DSF ) and standard formula ( SF ) administration in type 2 diabetic patients .
METHODS	Thirty type 2 diabetic patients were included in the present randomized , controlled , double-blind , cross-over study .
METHODS	Subjects received DSF and isocaloric SF as a bolus administration of 400 mL while continuing their anti-diabetic medications .
METHODS	Venous blood samples were collected and analyzed to assess plasma glucose levels at pre - and at 30 , 60 , 90 , 120 , and 180 min post-administration of the formulas .
RESULTS	Postprandial glucose profiles were significantly lower with DSF compared to SF administration determined as a mean glucose concentration at 2-hour post-administration .
RESULTS	The glucose area under the curve ( AUC ) after DSF consumption was 33 % lower than the AUC after SF consumption , p < 0.001 .
CONCLUSIONS	Use of DSF resulted in a significantly lower postprandial rise in plasma glucose concentrations than using SF .
CONCLUSIONS	It should be the preferred option in diabetic patients who need nutritional support .

###25514098
BACKGROUND	Irisin is a recently identified exercise-induced myokine .
BACKGROUND	However , the circulating levels of irisin in response to different types of exercise in subjects with metabolic syndrome are unknown .
OBJECTIVE	This study aimed to study the levels of irisin in healthy males and subjects with metabolic syndrome at baseline and in response to exercise .
METHODS	Each individual completed high-intensity interval exercise ( HIIE ) , continuous moderate-intensity exercise ( CME ) , and resistance exercise ( RE ) sessions in a random , crossover design .
METHODS	Percentage change in circulating irisin levels was examined .
METHODS	Two different irisin assays were used to compare the results of the RE study .
RESULTS	Circulating irisin increased immediately after HIIE , CME , and RE and declined 1 hour later .
RESULTS	The increase was greater in response to resistance compared with either high-intensity intermittent exercise or CME .
RESULTS	Change in irisin in response to exercise did not differ between individuals with and without metabolic syndrome .
CONCLUSIONS	Exercise is able to increase circulating irisin levels in individuals with the metabolic syndrome as well as healthy individuals .
CONCLUSIONS	Whether this increase may contribute to the beneficial effects of exercise on patients with the metabolic syndrome remains to be studied further .

###24825528
BACKGROUND	Blacks receive live donor kidney transplant ( LDKT ) less often than patients of all other races .
BACKGROUND	We evaluated the effectiveness of educational interventions in removing barriers to LDKT for blacks .
METHODS	Patients were randomized to three interventions in which health educator ( s ) delivered an intervention to ( a ) the patient and his/her guests in the patient 's home ( house calls [ HC ] , n = 54 ) , ( b ) clusters of patients and their guests in the transplant center ( group based [ GB ] , n = 49 ) , and ( c ) the individual patient alone in the transplant center ( individual counseling [ IC ] , n = 49 ) .
RESULTS	At the 2-year endpoint , 15 % ( n = 8 ) , 8 % ( n = 4 ) , and 6 % ( n = 3 ) of HC , GB , and IC patients , respectively , received LDKT ( P = 0.30 ) .
RESULTS	Patients in the HC group were more likely than patients in the GB and IC groups to have at least one donor inquiry ( 82 % vs. 61 % vs. 47 % , P = 0.001 ) and evaluation ( 65 % vs. 39 % vs. 27 % , P < 0.001 ) .
RESULTS	Patients in the HC group also were more likely to have higher knowledge , fewer concerns , and higher willingness to talk to others about donation 6 weeks after intervention .
CONCLUSIONS	These findings underscore the importance of including the patient 's social network in LDKT education and the potential of the HC intervention to reduce racial disparity in LDKT rates .

###24481686
BACKGROUND	Shared decision making is a crucial component of evidence-based practice , but a lack of training in the `` how to '' of it is a major barrier to its uptake .
OBJECTIVE	To evaluate the effectiveness of a brief intervention for facilitating shared decision making skills in clinicians and student clinicians .
METHODS	Multi-centre randomized controlled trial .
METHODS	One hundred and seven medical students , physiotherapy or occupational therapy students undertaking a compulsory course in evidence-based practice as part of their undergraduate or postgraduate degree from two Australian universities .
METHODS	The 1-h small-group intervention consisted of facilitated critique of five-step framework , strategies , and pre-recorded modelled role-play .
METHODS	Both groups were provided with a chapter about shared decision making skills .
METHODS	The primary outcome was skills in shared decision making and communicating evidence [ Observing Patient Involvement ( OPTION ) scale , items from the Assessing Communication about Evidence and Patient Preferences ( ACEPP ) Tool ] , rated by a blinded assessor from videorecorded role-plays .
RESULTS	confidence in these skills and attitudes towards patient-centred communication ( Patient Practitioner Orientation Scale ( PPOS ) ) .
RESULTS	Of participants , 95 % ( 102 ) completed the primary outcome measures .
RESULTS	Two weeks post-intervention , intervention group participants scored significantly higher on the OPTION scale ( adjusted group difference = 18.9 , 95 % CI 12.4 to 25.4 ) , ACEPP items ( difference = 0.9 , 95 % CI 0.5 to 1.3 ) , confidence measure ( difference = 13.1 , 95 % CI 8.5 to 17.7 ) , and the PPOS sharing subscale ( difference = 0.2 , 95 % CI 0.1 to 0.5 ) .
RESULTS	There was no significant difference for the PPOS caring subscale .
CONCLUSIONS	This brief intervention was effective in improving student clinicians ' ability , attitude towards , and confidence in shared decision making facilitation .
CONCLUSIONS	Following further testing of the longer-term effects of this intervention , incorporation of this brief intervention into evidence-based practice courses and workshops should be considered , so that student clinicians graduate with these important skills , which are typically neglected in clinician training .

###25271396
OBJECTIVE	This randomised trial tested ( i ) whether a home-based expressive writing ( EW ) intervention improves quality of life in patients with colorectal cancer ( CRC ) and ( ii ) whether the intervention is more beneficial for men or for people who feel constrained in disclosing cancer-related concerns and feelings .
METHODS	Patients treated for CRC were randomised to an EW ( n = 101 ) or control writing ( CW ; n = 92 ) group .
METHODS	Assessments were completed at 1 month pre - and post-intervention .
METHODS	Sex and perceived social constraints on disclosure were evaluated as moderators .
METHODS	Primary outcomes were depressive symptoms , sleep problems and quality of life indicators .
RESULTS	Eighty-one per cent of participants completed all writing assignments .
RESULTS	Consistent with hypotheses , relative to the CW group , participants in the EW group expressed more negative emotion in writing and rated their writings as more meaningful , personal and emotionally revealing .
RESULTS	There were no significant main effects of EW or moderating effects of sex or social constraints on outcomes .
CONCLUSIONS	Although EW is feasible to use with persons who have CRC , it was not effective as a stand-alone psychotherapeutic intervention .
CONCLUSIONS	Neither was it more effective for men nor for people who felt they could not freely disclose cancer-related concerns and feelings .

###24961184
OBJECTIVE	Ideal fluid management during surgery still poses a clinical dilemma gauging the benefits and adverse effects .
OBJECTIVE	This randomized controlled trial compared the tissue perfusion and coagulation profiles under clinically equivalent hydroxyethyl starch ( HES 130/0 .4 ) and lactated Ringer 's solution ( LR ) .
METHODS	Eighty-four patients undergoing major abdominal surgery were randomized to receive either HES or LR .
METHODS	Tissue perfusion parameters using heart rate , arterial blood pressure , central venous pressure , cardiac index , stroke volume index , and central venous oxygen saturation were measured at T0 ( baseline ) , T1 ( start of surgery ) , T2 ( 1 hour after start of surgery ) , and T3 ( end of surgery ) .
METHODS	Coagulation parameters using thrombelastography ( TEG ) were measured at T0 ( baseline ) , T4 ( after 15mL/kg fluid transfused ) , and T5 ( 24 hours after baseline ) .
RESULTS	The total amount of fluid administrated was 1547.9424.0 mL in HES group and 2303.11033.7 mL in LR group ( p < 0.001 ) .
RESULTS	The parameters of tissue perfusion and TEG did not differ significantly between groups at any time point except for a transient decrease in clot kinetic and clot strength at T4 for HES group .
RESULTS	There was no significant difference in blood loss and consumption of blood products between the two fluids .
CONCLUSIONS	HES 130/0 .4 is a more efficient intravascular volume expander to maintain tissue perfusion than conventional crystalloid .
CONCLUSIONS	Transient hypocoagulability induced by HES 130/0 .4 does not warrant excessive blood loss and blood transfusion .

###25071343
OBJECTIVE	To determine the relationship between host immunity and the characteristics of viral infection or nucleoside analogues ( NAs ) themselves in patients with chronic hepatitis B ( CHB ) receiving NA therapy .
METHODS	Fifty-two hepatitis B envelope antigen ( HBeAg ) positive CHB patients were enrolled and divided equally into two groups .
METHODS	One group received telbivudine ( LDT , 600 mg/d ) , and the other group received lamivudine ( LAM , 100 mg/d ) .
METHODS	Clinical , virological and immunological parameters were assessed at the baseline and at 4 , 12 , 24 , 36 and 48 wk .
RESULTS	Both groups achieved significant hepatitis B virus ( HBV ) replication inhibition and alanine aminotransferase normalization at 48 wk .
RESULTS	At the baseline , compared to healthy controls , CHB patients had a lower circulating CD8 T cell frequency ( 29.44 % 11.55 % vs 37.17 % 7.30 % , P = 0.03 ) and higher frequencies of programmed death 1 positive CD8 T cells ( PD-1 + CD8 T ) ( 16.48 % 10.82 % vs 7.02 % 3.62 % , P = 0.0001 ) and CD4 + CD25 + FoxP3 + T regulatory cells ( Tregs ) ( 23.64 % 9.38 % vs 13.60 % 6.06 % , P = 0.001 ) .
RESULTS	On therapy , at the beginning 24 wk with the levels of hepatitis B virus deoxyribonucleic acid ( HBV DNA ) and HBeAg declining , the frequencies of PD-1 + CD8 T cells and Treg cells gradually and significantly declined at 12 and 24 wk in both therapy groups .
RESULTS	At treatment week 4 , patients treated with LDT had a lower frequency of PD-1 + CD8 T cells compared to patients treated with LAM ( 10.08 % 6.83 % vs 20.51 % 20.96 % , P = 0.02 ) .
RESULTS	The frequency of PD-1 + CD8 T cells in all of the CHB patients was significantly correlated with both the HBV DNA level ( r = 0.45 , P = 0.01 ) and HBeAg level ( r = 0.47 , P = 0.01 ) at treatment week 24 , but the frequency of Treg cells was only significantly correlated with the HBeAg level ( r = 0.44 , P = 0.02 ) .
RESULTS	Furthermore , the ability of CD8 T cells to secrete pro-inflammatory cytokines was partially restored after 24 wk of therapy .
CONCLUSIONS	NA-mediated HBV suppression could down-regulate the production of negative regulators of host immunity during the first 24 wk of therapy and could partially restore the ability of CD8 T cells to secrete pro-inflammatory cytokines .
CONCLUSIONS	This immune modulating response may be correlated with the levels of both HBV DNA and HBeAg .

###25536255
OBJECTIVE	Patient-centered medical homes have not been shown to reduce adverse outcomes or costs in adults or children with chronic illness .
OBJECTIVE	To assess whether an enhanced medical home providing comprehensive care prevents serious illness ( death , intensive care unit [ ICU ] admission , or hospital stay > 7 days ) and/or reduces costs among children with chronic illness .
METHODS	Randomized clinical trial of high-risk children with chronic illness ( 3 emergency department visits , 2 hospitalizations , or 1 pediatric ICU admissions during previous year , and > 50 % estimated risk for hospitalization ) treated at a high-risk clinic at the University of Texas , Houston , and randomized to comprehensive care ( n = 105 ) or usual care ( n = 96 ) .
METHODS	Enrollment was between March 2011 and February 2013 ( when predefined stopping rules for benefit were met ) and outcome evaluations continued through August 31 , 2013 .
METHODS	Comprehensive care included treatment from primary care clinicians and specialists in the same clinic with multiple features to promote prompt effective care .
METHODS	Usual care was provided locally in private offices or faculty-supervised clinics without modification .
METHODS	Primary outcome : children with a serious illness ( death , ICU admission , or hospital stay > 7 days ) , costs ( health system perspective ) .
METHODS	Secondary outcomes : individual serious illnesses , medical services , Medicaid payments , and medical school revenues and costs .
RESULTS	In an intent-to-treat analysis , comprehensive care decreased both the rate of children with a serious illness ( 10 per 100 child-years vs 22 for usual care ; rate ratio [ RR ] , 0.45 [ 95 % CI , 0.28-0 .73 ] ) , and total hospital and clinic costs ( $ 16,523 vs $ 26,781 per child-year , respectively ; cost ratio , 0.58 [ 95 % CI , 0.38-0 .88 ] ) .
RESULTS	In analyses of net monetary benefit , the probability that comprehensive care was cost neutral or cost saving was 97 % .
RESULTS	Comprehensive care reduced ( per 100 child-years ) serious illnesses ( 16 vs 44 for usual care ; RR , 0.33 [ 95 % CI , 0.17-0 .66 ] ) , emergency department visits ( 90 vs 190 ; RR , 0.48 [ 95 % CI , 0.34-0 .67 ] ) , hospitalizations ( 69 vs 131 ; RR , 0.51 [ 95 % CI , 0.33-0 .77 ] ) , pediatric ICU admissions ( 9 vs 26 ; RR , 0.35 [ 95 % CI , 0.18-0 .70 ] ) , and number of days in a hospital ( 276 vs 635 ; RR , 0.36 [ 95 % CI , 0.19-0 .67 ] ) .
RESULTS	Medicaid payments were reduced by $ 6243 ( 95 % CI , $ 1302 - $ 11,678 ) per child-year .
RESULTS	Medical school losses ( costs minus revenues ) increased by $ 6018 ( 95 % CI , $ 5506 - $ 6629 ) per child-year .
CONCLUSIONS	Among high-risk children with chronic illness , an enhanced medical home that provided comprehensive care to promote prompt effective care vs usual care reduced serious illnesses and costs .
CONCLUSIONS	These findings from a single site of selected patients with a limited number of clinicians require study in larger , broader populations before conclusions about generalizability to other settings can be reached .
BACKGROUND	clinicaltrials.gov Identifier : NCT02128776 .

###24875670
OBJECTIVE	To compare the effect of 7 h of prolonged sitting on resting blood pressure with a similar duration of sitting combined with intermittent brief bouts of light-intensity or moderate-intensity physical activity .
RESULTS	Overweight/obese adults ( n = 19 ; aged 45-65 years ) were recruited for a randomized three-treatment crossover trial with a one-week washout between treatments : 1 ) uninterrupted sitting ; 2 ) sitting with 2 min bouts of light-intensity walking at 3.2 km/h every 20 min ; and , 3 ) sitting with 2 min bouts of moderate-intensity walking at between 5.8 and 6.4 km/h every 20 min .
RESULTS	After an initial 2 h period seated , participants consumed a test meal ( 75 g carbohydrate , 50 g fat ) and completed each condition over the next 5 h. Resting blood pressure was assessed oscillometrically every hour as a single measurement , 5 min prior to each activity bout .
RESULTS	GEE models were adjusted for sex , age , BMI , fasting blood pressure and treatment order .
RESULTS	After adjustment for potential confounding variables , breaking up prolonged sitting with light and moderate-intensity activity breaks was associated with lower systolic blood pressure [ light : 120 1 mmHg ( estimated marginal mean SEM ) , P = 0.002 ; moderate : 121 1 mmHg , P = 0.02 ] , compared to uninterrupted sitting ( 123 1 mmHg ) .
RESULTS	Diastolic blood pressure was also significantly lower during both of the activity conditions ( light : 76 1 mmHg , P = 0.006 ; moderate : 77 1 mmHg , P = 0.03 ) compared to uninterrupted sitting ( 79 1 mmHg ) .
RESULTS	No significant between-condition differences were observed in mean arterial pressure or heart rate .
CONCLUSIONS	Regularly breaking up prolonged sitting may reduce systolic and diastolic blood pressure .
BACKGROUND	ACTRN12609000656235 ( http://www.anzctr.org.au ) TRIAL REGISTRATION DATE : August 4th 2009 .

###25290658
BACKGROUND	Physical illnesses frequently co-occur with depression and substance use disorders and may impact their improvement .
BACKGROUND	Physical illness symptoms may overlap with or exacerbate somatic symptoms of depression .
BACKGROUND	Individuals may use substances to cope with symptoms of physical illness .
OBJECTIVE	We examined whether chronic physical health problems moderated changes in depression and substance use among dual diagnosed individuals during and in the year following treatment .
METHODS	Participants were recruited from a Veterans Affairs dual diagnosis outpatient program between March 2000 and November 2007 and were randomized to either Integrated Cognitive-Behavioral Therapy or Twelve-Step Facilitation Therapy .
METHODS	A total of 214 veterans with assessment data for the variables of interest were included in analyses .
METHODS	Participants completed quarterly depression , substance use , and health assessments over an 18 month period .
METHODS	We used linear-mixed effects models to analyze patterns of change for depression and substance use .
RESULTS	Individuals with severe chronic health problems and higher intake depression showed slower improvements in both nonsomatic and somatic depression symptoms .
RESULTS	Individuals with severe chronic health problems and higher midtreatment substance use showed less improvement in substance use .
CONCLUSIONS	Assessing and addressing physical health issues during depression and substance use disorder treatment may improve outcomes .

###24340150
BACKGROUND	Several different surgical techniques have been described to address the coracoclavicular ( CC ) ligaments in acromioclavicular ( AC ) joint injuries .
BACKGROUND	However , very few techniques focus on reconstructing the AC ligaments , despite its importance in providing stability .
BACKGROUND	The purpose of our study was to compare the biomechanical properties of two free-tissue graft techniques that reconstruct both the AC and CC ligaments in cadaveric shoulders , one with an extramedullary AC reconstruction and the other with an intramedullary AC reconstruction .
BACKGROUND	We hypothesized intramedullary AC reconstruction will provide greater anteroposterior translational stability and improved load to failure characteristics than an extramedullary technique .
METHODS	Six matched cadaveric shoulders underwent translational testing at 10 N and 15 N in the anteroposterior and superoinferior directions , under AC joint compression loads of 10 N , 20 N , and 30 N.
METHODS	After the AC and CC ligaments were transected , one of the specimens was randomly assigned the intramedullary free-tissue graft reconstruction while its matched pair received the extramedullary graft reconstruction .
METHODS	Both reconstructed specimens then underwent repeat translational testing , followed by load to failure testing , via superior clavicle distraction , at a rate of 50 mm/min .
RESULTS	Intramedullary reconstruction provided significantly greater translational stability in the anteroposterior direction than the extramedullary technique for four of six loading conditions ( p < 0.05 ) .
RESULTS	There were no significant differences in translational stability in the superoinferior direction for any loading condition .
RESULTS	The intramedullary reconstructed specimens demonstrated improved load to failure characteristics with the intramedullary reconstruction having a lower deformation at yield and a higher ultimate load than the extramedullary reconstruction ( p < 0.05 ) .
CONCLUSIONS	Intramedullary reconstruction of the AC joint provides greater stability in the anteroposterior direction and improved load to failure characteristics than an extramedullary technique .
CONCLUSIONS	Reconstruction of the injured AC joint with an intramedullary free tissue graft may provide greater strength and stability than other currently used techniques , allowing patients to have improved clinical outcomes .

###25017487
BACKGROUND	Pharmacokinetic data regarding a drug-drug interaction between everolimus and tacrolimus are sparse .
METHODS	In a pharmacokinetic substudy of the randomized ASSET trial , 46 de novo kidney transplant patients receiving very low ( 1.5-3 ng/mL ) or low ( 4-7 ng/mL ) tacrolimus exposure after month 3 , both with everolimus and steroids , provided area under the curve ( AUC ) concentration profiles at day 5 and months 1 , 3 , and 12 .
RESULTS	At month 12 , mean values for tacrolimus trough concentration ( C0 ) , peak concentration ( Cmax ) , and AUC0-12 in the very low tacrolimus group were approximately half that in the low tacrolimus group , but everolimus dose , C0 , Cmax , and AUC0-12 were virtually identical in both groups .
RESULTS	In a cross-study comparison with data at months 1 and 3 from the pharmacokinetic substudy of the A2307 trial , in which patients received cyclosporine , mean values for everolimus C0 , Cmax and AUC0-12 were similar to those in the ASSET trial but the everolimus dose needed to achieve similar exposure was 1.5 - to 2-fold higher with concomitant tacrolimus versus cyclosporine .
CONCLUSIONS	Everolimus exposure is unaffected when tacrolimus exposure is down-titrated within the trough concentration range of 1.5-7 ng/mL .
CONCLUSIONS	Higher doses of everolimus are needed to achieve a given exposure when combined with tacrolimus versus cyclosporine .

###24239143
OBJECTIVE	Patient-relevant treatment benefit is traditionally measured with health-related quality of life ( HRQoL ) instruments .
OBJECTIVE	The Patient Benefit Index ( PBI ) methodology allows for a more direct measurement , with the patients rating both importance and achievement of treatment goals .
OBJECTIVE	Here , we developed and validated a PBI version specific for the assessment of benefit in lymphedema and lipedema treatment ( PBI-L ) .
METHODS	The development included five steps : ( 1 ) open item collection ; ( 2 ) consensus of items in a multidisciplinary expert panel ; ( 3 ) application of the German PBI-L in a cross-sectional study ( n = 301 ) ; ( 4 ) translation into English ; ( 5 ) application of the English PBI-L in a randomized clinical trial ( n = 82 ) .
METHODS	Subscales were developed using factor analysis .
METHODS	Construct validity was analyzed by correlating PBI-L and convergent criteria such as HRQoL and quality of care .
METHODS	To test for responsiveness , the association to change in HRQoL measures was computed .
RESULTS	Floor and ceiling effects were low .
RESULTS	There were few missing values .
RESULTS	Two well-interpretable subscales were found with Cronbach 's alpha > 0.8 each .
RESULTS	Global and subscale scores correlated with convergent criteria and with change in disease-specific HRQoL , but not with change in generic HRQoL .
CONCLUSIONS	The PBI-L is an internally consistent , valid , and responsive instrument for the assessment of patient-relevant benefit of edema treatment .

###25728723
BACKGROUND	Heart failure ( HF ) is a major public health problem affecting predominantly older adults .
BACKGROUND	Nonadherence to diet remains a significant contributor to acute decompensated HF ( ADHF ) .
BACKGROUND	The sodium-restricted Dietary Approaches to Stop Hypertension ( DASH/SRD ) eating plan reduces cardiovascular dysfunction that can lead to ADHF and is consistent with current HF guidelines .
BACKGROUND	We propose that an intervention that promotes adherence to the DASH/SRD by home-delivering meals will be safe and improve health-related quality of life ( QOL ) in older adults after hospitalization for ADHF .
METHODS	This is a 3-center , randomized , single-blind , controlled trial of 12-week duration designed to determine the safety and efficacy of home-delivered DASH/SRD-compliant meals in older adults after discharge from ADHF hospitalization .
METHODS	Sixty-six subjects will be randomized in a 1:1 stratified fashion by gender and left ventricular ejection fraction ( < 50 % vs 50 % ) .
METHODS	Study subjects will receive either preprepared , home-delivered DASH/SRD-compliant meals or usual dietary advice for 4weeks after hospital discharge .
METHODS	Investigators will be blinded to group assignment , food diaries , and urinary electrolyte measurements until study completion .
METHODS	The primary efficacy end point is the change in the Kansas City Cardiomyopathy Questionnaire summary scores for health-related QOL from study enrollment to 4weeks postdischarge .
METHODS	Safety evaluation will focus on hypotension , renal insufficiency , and hyperkalemia .
METHODS	Exploratory end points include echocardiography , noninvasive vascular testing , markers of oxidative stress , and salt taste sensitivity .
CONCLUSIONS	This randomized controlled trial will test the efficacy , feasibility , and safety of 4weeks of DASH/SRD after ADHF hospitalization .
CONCLUSIONS	By testing a novel dietary intervention supported by multiple levels of evidence including preliminary data in outpatients with stable HF , we will address a critical evidence gap in the care of older patients with ADHF .
CONCLUSIONS	If effective and safe , this intervention could be scaled to assess effects on readmission and healthcare costs in older adults after ADHF .

###24450252
OBJECTIVE	It has been observed that a large number of patients with low urinary tract symptoms due to benign prostatic hyperplasia ( LUTS/BPH ) ) has been treated with a combination of tamsulosin ( TAM ) + Serenoa repens ( SR ) ( TAM + SR ) .
OBJECTIVE	The aim of this study was to compare a combination TAM + SR with TAM and SR alone , to see if there was any difference in efficacy and tolerance of each in patients with LUTS/BPH .
METHODS	In this prospective study patients had to have prostate volume ( PV ) < 50 mL , International Prostate Symptom Score ( IPSS ) of 7-18 , Quality of Life score ( QoLs ) > 3 , a maximal flow rate ( Qmax ) of 5-15 mL/s , with post voiding residual volume ( PVR ) < 150 mL and serum prostatic antigen ( PSA ) < 4 ng/mL .
METHODS	TAM ( 0.4 mg ) was administered once a day , SR ( 320 mg ) daily or SR ( 320 mg ) + TAM ( 0.4 mg ) daily for a median period of 6 months .
RESULTS	A total of 297 patients were recruited , whereas 265 patients were fully available : 87 into the group TAM , 97 into the group SR and 81 into the group TAM + SR. .
RESULTS	There was no statistically significant difference between the treatment groups in the sense of demographic and other baseline parameters .
RESULTS	No difference was found among the 3 treatment groups , neither in the major endpoint of the study in the sense of a change between baseline and final evaluation in total IPSS , obstructive and irritative subscores , improvement of QoLs , increase in Qmax , nor for the second endpoint including diminution of PV , PSA and PVR .
RESULTS	During the treatment period 20 ( 23 % ) of the patients managed with TAM and 17 ( 21 % ) with TAM + SR had drug - treated with related adverse reactions .
RESULTS	No adverse effect was detected in the group SR. .
CONCLUSIONS	Treatment of BPH by both SR and TAM seems to be efficacious alone .
CONCLUSIONS	None of them had superiority over another and , additionally , a combined therapy ( TAM + SR ) does not provide extra benefits .
CONCLUSIONS	Furthermore , SR is a well-tolerated agent that can be used alternatively in the treatment of LUTS/BPH .

###24439637
OBJECTIVE	This study investigated the effect of high frequency transcutaneous electric nerve stimulation ( TENS ) as a pain relieving complementary therapy at the transition from epidural ( EDA ) to general analgesia after pancreatic surgery by horizontal , abdominal incision .
METHODS	Fifty-five consecutive patients undergoing pancreatic resection were enrolled in the study and randomly assigned to active or sham TENS treatment .
METHODS	Twenty subjects were included in the analysis .
METHODS	Pain , quality of recovery and additional analgesia consumption were measured during the 24hof transition from EDA to general analgesia .
RESULTS	Additional analgesic consumption and pain estimations at 24hafter EDA termination differed between the two groups , but was not statistically significant .
CONCLUSIONS	This study did not find support to reject use of high frequency TENS as complement during transition from EDA to general analgesia after major abdominal surgery with horizontal incision .

###24432627
OBJECTIVE	To assess the efficacy of Yiqi Zhujing Particle in the treatment of idiopathic oligoasthenozoospermia .
METHODS	We equally randomized 78 patients with idiopathic oligoasthenozoospermia to a control group and a Yiqi Zhujing group , the former treated with oral medication of zinc gluconate liquid ( 10 ml , bid ) and vitamin E ( 100 mg , bid ) , and the latter given Yiqi Zhujing Granule ( 1 packet , bid ) in addition , both for 3 months .
METHODS	We compared the semen parameters and biochemical indexes of the seminal plasma obtained before and after medication between the two groups of patients .
RESULTS	After 3 months of treatment , remarkable improvement was observed in the percentage of progressively motile sperm and sperm viability in the control group ( P < 0.05 ) as well as in the total sperm count , sperm concentration , percentage of progressively motile sperm , and sperm viability in the Yiqi Zhujing group ( P < 0.05 ) .
RESULTS	The total sperm count , sperm concentration , percentage of progressively motile sperm , and sperm viability were even more significantly improved in the Yiqi Zhujing than in the control group ( P < 0.05 ) .
RESULTS	Besides , both groups showed different degrees of improvement in the biochemical indexes of the seminal plasma , and the Yiqi Zhujing group exhibited even more significant improvement in seminal plasma zinc , alpha-glucoside enzyme , seminal plasma fructose , and acid phosphatase than the control ( P < 0.05 ) .
RESULTS	The improvement of sperm concentration was correlated positively with the change of seminal plasma zinc ( r = 0.201 , P < 0.05 ) but negatively with that of seminal plasma fructose after treatment ( r = -0.136 , P < 0.05 ) .
RESULTS	There was a positive correlation between the alpha-glucoside enzyme level and sperm viability ( r = 0.314 , P < 0.05 ) .
CONCLUSIONS	Yiqi Zhujing Particle is effective for idiopathic oligoasthenozoospermia by significantly improving the total sperm count , sperm concentration , percentage of progressively motile sperm , sperm viability , seminal plasma zinc , seminal plasma fructose , and alpha-glucoside enzyme .

###24969577
OBJECTIVE	Agents that augment GLP-1 effects enhance glucose-dependent - cell insulin production and secretion and thus are hoped to prevent progressive impairment in insulin secretion characteristic of type 2 diabetes ( T2D ) .
OBJECTIVE	The purpose of this study was to evaluate GLP-1 effects on - cell secretory capacity , an in vivo measure of functional - cell mass , early in the course of T2D .
METHODS	We conducted a randomized controlled trial in 40 subjects with early T2D who received the GLP-1 analog exenatide ( n = 14 ) , the dipeptidyl peptidase IV inhibitor sitagliptin ( n = 12 ) , or the sulfonylurea glimepiride ( n = 14 ) as an active comparator insulin secretagogue for 6 months .
METHODS	Acute insulin responses to arginine ( AIRarg ) were measured at baseline and after 6 months of treatment with 5 days of drug washout under fasting , 230 mg/dL ( glucose potentiation of arginine-induced insulin release [ AIRpot ] ) , and 340 mg/dL ( maximum arginine-induced insulin release [ AIRmax ] ) hyperglycemic clamp conditions , in which AIRmax provides the - cell secretory capacity .
RESULTS	The change in AIRpot was significantly greater with glimepiride versus exenatide treatment ( P < 0.05 ) , and a similar trend was notable for the change in AIRmax ( P = 0.1 ) .
RESULTS	Within each group , the primary outcome measure , AIRmax , was unchanged after 6 months of treatment with exenatide or sitagliptin compared with baseline but was increased with glimepiride ( P < 0.05 ) .
RESULTS	- Cell glucagon secretion ( AGRmin ) was also increased with glimepiride treatment ( P < 0.05 ) , and the change in AGRmin trended higher with glimepiride than with exenatide ( P = 0.06 ) .
CONCLUSIONS	After 6 months of treatment , exenatide or sitagliptin had no significant effect on functional - cell mass as measured by - cell secretory capacity , whereas glimepiride appeared to enhance - and - cell secretion .

###25266357
OBJECTIVE	The aim of this study was to assess whether bladder training ( BT ) combined with high-intensity pelvic floor muscle training ( BT+PFMT ) results in better outcomes in the short term than BT alone on female urinary incontinence ( UI ) .
METHODS	We randomly assigned 108 women with diagnoses of stress UI ( SUI , n = 50 ) , urgency UI ( UUI , n = 16 ) , or mixed UI ( MUI , n = 42 ) to 6 weeks of BT+PFMT or BT alone ( control group ) .
METHODS	The primary outcome measure was self-reported improvement .
METHODS	Secondary outcome measures were UI severity , symptom distress , quality of life ( QOL ) , mean number of UI episodes and micturitions per day , and pelvic floor muscle strength and endurance ( PFME ) .
RESULTS	Overall and in the SUI and MUI subgroups , significantly more patients in the BT+PFMT group reported cured and improved symptoms .
RESULTS	Overall and in SUI patients , the BT+PFMT group also improved to significantly greater degree in UI severity , symptom distress , QOL , daily UI episodes , and PFME .
RESULTS	The only parameter showing more improvement in patients with UUI was QOL , and UI severity in patients with MUI ( p < 0.05 ) .
RESULTS	There were no other significant differences between the two study groups in overall and subgroup analysis ( p > 0.05 ) .
CONCLUSIONS	High-intensity PFMT combined with BT is more effective than BT alone in the short term for treating UI or SUI .
CONCLUSIONS	It appears that the combination therapy may also lead to greater benefits for patients with UUI and MUI .
CONCLUSIONS	Based on the results of this study , further studies with larger sample sizes ( for UUI ) and long-term follow-ups are warranted .

###24339179
OBJECTIVE	To examine the effect of certolizumab pegol ( CZP ) on patient-reported outcomes ( PROs ) in psoriatic arthritis ( PsA ) patients with and without prior tumor necrosis factor ( TNF ) inhibitor exposure .
METHODS	The ongoing phase III RAPID-PsA trial was double blind and placebo controlled to week 24 .
METHODS	Patients were randomized 1:1:1 to placebo every 2 weeks or CZP 400 mg at weeks 0 , 2 , and 4 , followed by either CZP 200 mg every 2 weeks or CZP 400 mg every 4 weeks .
METHODS	PRO measures evaluated were the Health Assessment Questionnaire ( HAQ ) disability index ( DI ) , health status ( measured by the Short Form 36 [ SF-36 ] health survey ) , Psoriatic Arthritis Quality of Life ( PsAQOL ) , Fatigue Assessment Scale , patient assessment of pain ( visual analog scale ) , and Dermatology Life Quality Index ( DLQI ) .
METHODS	Post hoc analyses of PROs in patients with and without prior TNF inhibitor exposure were conducted .
METHODS	Change from baseline for all PROs was analyzed for the randomized population using analysis of covariance with last observation carried forward imputation .
RESULTS	A total of 409 patients were randomized .
RESULTS	Twenty percent had received a prior TNF inhibitor .
RESULTS	Baseline demographics were similar between the treatment groups .
RESULTS	At week 24 , clinically meaningful differences in HAQ DI , SF-36 , PsAQOL , fatigue , pain , and DLQI were observed in both CZP arms versus placebo ( P < 0.001 ) , irrespective of prior TNF inhibitor exposure .
RESULTS	More CZP-treated patients reached SF-36 general population norms than placebo-treated patients .
CONCLUSIONS	Both CZP dosing schedules provided rapid improvements in PROs across multiple disease aspects in patients with PsA .
CONCLUSIONS	The benefits of CZP treatment for health-related quality of life were seen across generic , PsA-specific , and dermatology-specific measures and were observed in patients regardless of prior TNF inhibitor exposure .

###25395844
OBJECTIVE	The purpose of the study was to evaluate the effect of BodyBalance ( ) training on balance , functional task performance , fear of falling , and health-related quality of life in adults aged over 55 years .
METHODS	A total of 28 healthy , active adults aged 665 years completed the randomized controlled trial .
METHODS	Balance , functional task performance , fear of falling , and self-reported quality of life were assessed at baseline and after 12 weeks .
METHODS	Participants either undertook two sessions of BodyBalance per week for 12 weeks ( n = 15 ) or continued with their normal activities ( n = 13 ) .
RESULTS	Significant group-by-time interactions were found for the timed up and go ( P = 0.038 ) , 30-second chair stand ( P = 0.037 ) , and mediolateral center-of-pressure range in narrow stance with eyes closed ( P = 0.017 ) .
RESULTS	There were no significant effects on fear of falling or self-reported quality of life .
CONCLUSIONS	Twelve weeks of BodyBalance training is effective at improving certain balance and functional based tasks in healthy older adults .

###24512733
OBJECTIVE	Acute inflammation induced by administration of Escherichia coli lipopolysaccharide endotoxin ( LPS ) reduces plasma concentrations of vitamin C and impairs vascular endothelium-derived nitric oxide ( NO ) bioactivity .
OBJECTIVE	We tested the hypothesis that systemically administered high dose vitamin C restores the endogenous anti-oxidant potential and improves NO-dependent vasodilatation in the forearm vasculature .
METHODS	36 male subjects were enrolled in this balanced , placebo controlled cross-over study .
METHODS	Forearm blood flow ( FBF ) reactivity to acetylcholine ( ACh ) and glyceryl-trinitrate ( GTN ) , a sensitive test for endothelial function , was assessed at baseline and 4h after LPS-administration ( 20 IU/kg i.v ) .
METHODS	The effect of two different doses of intravenous vitamin C ( Vitamin C-Injektopas ) , 320 mg/kg and 480 mg/kg over 2h , or placebo on forearm vascular function was studied after LPS .
RESULTS	LPS caused transient flu-like symptoms , decreased plasma vitamin C concentrations and reduced the ACh-dependent increase in FBF by up to 76 % .
RESULTS	Vitamin C at a mean plasma concentration of 3.2 or 4.9 mmol/L restored the response to ACh compared to baseline .
CONCLUSIONS	High dose systemic vitamin C recovers LPS-induced endothelium-dependent vasodilation in the forearm resistance vasculature .
CONCLUSIONS	This provides a rationale for a further clinical study of the systemic vitamin C effect under inflammatory conditions .

###24743062
BACKGROUND	The prevalence of multiple somatic symptoms is high in primary and hospital outpatient populations .
BACKGROUND	Multiple somatic symptoms may be present in patients sick-listed because of low back pain ( LBP ) and may be associated with increased risk of not returning to work ( RTW ) .
OBJECTIVE	To explore whether multiple somatic symptoms in a subset of patients with nonspecific LBP was associated with RTW , sickness absence ( SA ) , or other social benefits .
METHODS	The study was a cohort study based on a randomized clinical trial with a prospective 2-year follow-up period .
METHODS	Patients were referred from general practices to the Spine Center , Regional Hospital Silkeborg , Denmark .
METHODS	Patients were 285 sick-listed employees ( 4-12 weeks ) , with nonspecific LBP as their prime reason for SA .
METHODS	Exclusion criteria were unemployment , radiculopathy , LBP surgery within the past year , previous lumbar fusion , suspected cauda equina syndrome , progressive paresis or other serious back disease , pregnancy , known substance abuse , or primary psychiatric diagnosis .
METHODS	Self-reported health was assessed by the LBP rating scale and questions about pain and health in general .
METHODS	Disabilities were measured by the Roland Morris Questionnaire , the Short Form-36 , and the Fear-Avoidance Beliefs Questionnaire .
METHODS	Work-related questions comprised expectations about RTW and risk of losing job because of SA .
METHODS	The Common Mental Disorder Questionnaire ( subscale SCL-SOM ) was used to assess multiple somatic symptoms ( 12 items ) .
METHODS	We categorized multiple somatic symptoms into four groups based on the SCL-SOM sum score : < 6 , 6 to 12 , 13 to 18 and > 18 .
METHODS	Status of SA ( > 2 weeks ) and RTW were gathered from a national database ( DREAM ) .
METHODS	The patients ( N = 285 ) were randomized into either multidisciplinary or brief intervention at the Spine Center ( 2004-2008 ) .
METHODS	Both interventions comprised clinical examination and advice by a physiotherapist and a rheumatologist .
METHODS	Data were collected from questionnaires at baseline ( inclusion ) and 1 year after inclusion .
METHODS	Data on SA benefits were gathered from the DREAM database that contains data on all social transfer payments ( such as sick leave benefits and other disability benefits ) registered on a weekly basis .
RESULTS	All health factors , female gender , and poor work ability were significantly associated with a higher level of multiple somatic symptoms .
RESULTS	The percentage of persons with SA increased significantly with the symptom score after 1 year , and the duration of SA remained significantly longer after 2 years of follow-up between the multiple somatic symptoms groups .
RESULTS	The percentages with RTW after 1 and 2 years were negatively associated with a higher level of multiple somatic symptoms at baseline .
RESULTS	We found no difference between the intervention groups .
CONCLUSIONS	A higher level of multiple somatic symptoms was significantly associated with poor health and work ability at baseline and with longer duration of SA and unsuccessful RTW through a 2-year follow-up period .

###24556445
OBJECTIVE	Electrical and pharmacological cardioversion ( ECV , PCV ) are important treatment options for symptomatic patients with recent onset atrial fibrillation ( AF ) .
OBJECTIVE	RHYTHM-AF is an international registry of present-day cardioversion providing information that is not currently available on country differences and acute and long-term arrhythmia outcomes of ECV and PCV .
RESULTS	3940 patients were enrolled , of whom 75 % underwent CV .
RESULTS	All patients were followed for 2 months .
RESULTS	There were large variations concerning mode of CV used , ECV being heterogeneous .
RESULTS	A choice of PCV drug depended on the clinical patient profile .
RESULTS	Sinus rhythm was restored in 89.7 % of patients by ECV and in 69.1 % after PCV .
RESULTS	Among patients not undergoing CV during admission , 34 % spontaneously converted to sinus rhythm within 24h .
RESULTS	ECV was most successful in patients pretreated with antiarrhythmic drugs ( mostly amiodarone ) .
RESULTS	PCV was enhanced by class Ic antiarrhythmic drugs ; conversion rate on amiodarone was similar to that seen with rate control drugs .
RESULTS	Female patients and those with paroxysmal and first detected AF as well as those without previous ECV responded well to PCV .
RESULTS	The median duration of hospital stay was 16.2 and 24.0 h for ECV and PCV patients , respectively .
RESULTS	There were very few CV-related complications regardless of mode of CV .
RESULTS	Chronic maintenance of sinus rhythm was enhanced in patients on chronic antiarrhythmic drugs , beta-blockers or inhibitors of the renin-angiotensin system .
CONCLUSIONS	Mode of CV varied significantly , but both PCV and ECV were safe and effective .
CONCLUSIONS	Class Ic drugs were most effective conversion drugs , but amiodarone is used most frequently despite providing merely rate control rather than shorten time to conversion .

###25699687
BACKGROUND	Systemic hypothermia may reduce infarct size if established before reperfusion .
BACKGROUND	The large surface area of the bowel may facilitate rapid hypothermia .
BACKGROUND	We therefore examined the feasibility , safety , and efficacy of hypothermia induced by an automated peritoneal lavage system in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention .
RESULTS	Patients with ST-segment-elevation myocardial infarction within 6 hours of symptom onset were randomized to peritoneal hypothermia before and for 3 hours after percutaneous coronary intervention versus control .
RESULTS	The primary safety end point was the 30-day composite rate of death , reinfarction , ischemia-driven target vessel revascularization , major bleeding , sepsis , pneumonia , peritonitis , severe arrhythmia , or renal failure .
RESULTS	The primary efficacy end point was infarct size assessed by cardiac MRI on day 3 to 5 .
RESULTS	Fifty-four patients were randomized at 7 centers to hypothermia ( n = 28 ) versus control ( n = 26 ) .
RESULTS	Hypothermia was successfully initiated in 96.3 % of patients , and median [ interquartile range ] temperature at first balloon inflation was 34.7 [ 34.0-34 .9 ] C. Median door-to-balloon times in the hypothermia and control groups were 62 [ 51-81 ] and 47 [ 37-55 ] minutes , respectively ( P = 0.007 ) .
RESULTS	The primary safety end point occurred in 6 ( 21.4 % ) and 0 ( 0 % ) patients in the hypothermia and control groups , respectively ( P = 0.01 ) , including 3 versus 0 stent thrombosis events .
RESULTS	Infarct size was 17.2 % [ 15.1-20 .6 ] and 16.1 % [ 10.0-22 .2 ] in the hypothermia and control groups , respectively ( P = 0.54 ) .
CONCLUSIONS	Peritoneal hypothermia is feasible and achieves rapid cooling with only a modest increase in treatment times in the setting of ST-segment-elevation myocardial infarction .
CONCLUSIONS	However , in the present randomized trial , peritoneal hypothermia was associated with an increased rate of adverse events without reducing infarct size .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01655433 .

###24315404
OBJECTIVE	To determine whether concurrent chemoradiotherapy ( CCRT ) can improve survival rates compared to the neoadjuvant chemotherapy ( NACT ) regimen in locoregionally advanced nasopharyngeal carcinoma ( NPC ) patients .
METHODS	A total of 338 patients with biopsy-proven NPC were randomly assigned to receive NACT followed by radical radiotherapy ( RT ) then adjuvant chemotherapy ( AC ) or CCRT followed by AC .
RESULTS	With a median follow-up of 60 months , the 5-year overall survival ( OS ) rate did not differ significantly between two groups ( 75.5 % vs 79.4 % in CCRT and NACT group respectively , P = 0.47 , HR = 0.84 , 95 % CI 0.53-1 .33 ) .
RESULTS	Metastasis-free survival ( MFS ) rate was significantly improved by the CCRT ( 79.0 % vs 86.9 % , P = 0.05 , HR = 0.59 , 95 % CI 0.35-1 .00 ) .
RESULTS	Subgroup analysis indicated that the benefit of CCRT was derived from N0/N1 tumors ( 78.0 % vs 93.5 % , P = 0.05 , HR = 0.35 , 95 % CI 0.12-0 .99 ) .
RESULTS	Higher rates of mucositis ( 52.4 % vs. 35.9 % P = 0.02 ) and vomiting ( 13.7 % vs. 4.7 % P = 0.00 ) were noted in the CCRT arm .
RESULTS	Late toxicities were similar in two groups .
CONCLUSIONS	The updated results demonstrated no significant survival benefit of CCRT over NACT in patients with locoregionally advanced NPC .
CONCLUSIONS	CCRT only showed significant MFS efficacy in T3-4N0-1 populations .

###24393129
BACKGROUND	Lumbar transforaminal epidural injections are commonly utilized to treat radicular pain due to intervertebral disc herniation .
OBJECTIVE	This study aims to determine if there was a major difference in effectiveness between particulate and nonparticulate corticosteroids for acute radicular pain due to lumbar disc herniation .
METHODS	A multicenter , double blind , prospective , randomized trial on 78 consecutive subjects with acute uni-level disc herniation resulting in unilateral radicular pain .
METHODS	All subjects received a single level transforaminal epidural steroid injection with either dexamethasone or triamcinolone .
METHODS	Repeat injections were allowed as determined by the blinded physician and subjects .
METHODS	Primary outcomes included : number of injections received , surgical rates , and categorical pain scores at 2 weeks , 3 months , and 6 months .
METHODS	Secondary outcomes included mean Oswestry Disability Index .
RESULTS	Both triamcinolone and dexamethasone resulted in statically significant improvements in pain and function at 2 weeks , 3 months , and 6 months , without clear differences between groups .
RESULTS	The surgical rates were comparable with 14.6 % of the dexamethasone group and 18.9 % of the triamcinolone group receiving surgery .
RESULTS	There was a statistically significant difference in the number of injections received , with 17.1 % of the dexamethasone group receiving three injections vs only 2.7 % of the triamcinolone group .
CONCLUSIONS	Transforaminal epidural corticosteroid injections are an effective treatment for acute radicular pain due to disc herniation , and frequently only require 1 or 2 injections for symptomatic relief .
CONCLUSIONS	Dexamethasone appears to possess reasonably similar effectiveness when compared with triamcinolone .
CONCLUSIONS	However , the dexamethasone group received slightly more injections than the triamcinolone group to achieve the same outcomes .

###25162257
OBJECTIVE	To test the feasibility and effectiveness of a Web-based lifestyle intervention based on the Diabetes Prevention Program modified for women with recent gestational diabetes mellitus to reduce postpartum weight retention .
METHODS	We randomly allocated 75 women with recent gestational diabetes mellitus to either a Web-based lifestyle program ( Balance after Baby ) delivered over the first postpartum year or to a control group .
METHODS	Primary outcomes were change in body weight at 12 months from 1 ) first postpartum measured weight ; and 2 ) self-reported prepregnancy weight .
RESULTS	There were no significant differences in baseline characteristics between groups including age , body mass index , race , and income status .
RESULTS	Women assigned to the Balance after Baby program ( n = 36 , three lost to follow-up ) lost a mean of 2.8 kg ( 95 % confidence interval -4.8 to -0.7 ) from 6 weeks to 12 months postpartum , whereas the control group ( n = 39 , one lost to follow-up ) gained a mean of 0.5 kg ( -1.4 to +2.4 ) ( P = .022 ) .
RESULTS	Women in the intervention were closer to prepregnancy weight at 12 months postpartum ( mean change -0.7 kg ; -3.5 to +2.2 ) compared with women in the control arm ( +4.0 kg ; +1.3 to +6.8 ) ( P = .035 ) .
CONCLUSIONS	A Web-based lifestyle modification program for women with recent gestational diabetes mellitus decreased postpartum weight retention .
BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT01158131 .
METHODS	I.

###24617235
OBJECTIVE	To observe differences of therapeutic effects among acupuncture bloodletting , penicillin and acupuncture bloodletting combined with penicillin for children acute tonsillitis and providea better treatment method in cli nic .
METHODS	Seventy-five mild cases were selected into section of mild symptoms while seventy-five severe cases were selected into section of severe symptoms .
METHODS	Cases in the two sections then were divided into , an acupuncture bloodletting group , a penicillin group and a comprehensive group by random digital table method separately , 25 cases in each one .
METHODS	Qu-chi ( LI 11 ) , Hegu ( LI 4 ) , Dazhui ( GV 14 ) , Shaoshang ( LU 11 ) and Erjian ( EX 11 ) were selected in the acupuncture bloodletting group , intravenous injection of penicillin sodium was applied in the penicillin group and acupuncture bloodletting combined with penicillin was applied in the comprehensive group .
METHODS	Efficacy assessment was conducted after 3 days in the section of mild symptoms and after 5 days in the section of severe symptoms .
RESULTS	For the section of mild symptoms , the total effective rate was 96.0 % ( 24/25 ) in the comprehensive group and 92.0 % ( 23/25 ) in the acupuncture bloodletting group , which were both superior to 68.0 % ( 17/25 ) in the penicillin group ( P < 0.05 ) , but no statistical significance was seen between the comprehensive group and acupuncture bloodletting group ( P > 0.05 ) .
RESULTS	For the section of severe symptoms , the total effective rate was 96.0 % ( 24/25 ) in the comprehensive group , which was obviously superior to 60.0 % ( 15/25 ) in the acupuncture bloodletting group ( P < 0.01 ) and 68.0 % ( 17/25 ) in the penicillin group ( P < 0.05 ) , and no statistical significance was seen between the acupuncture bloodletting group and penicillin group ( P > 0.05 ) .
CONCLUSIONS	The efficacy of acupuncture bloodletting combined with penicillin is little different from that of acupuncture bloodletting for treatment of children acute tonsillitis with mild accompanied symptoms , which were both superior to intravenous injection of penicillin sodium .
CONCLUSIONS	For severe accompanied symptoms , the efficacy of acupuncture bloodletting combined with penicillin is obviously superior to acupuncture bloodletting and penicillin .

###24345717
OBJECTIVE	To evaluate the effects of sex and menopausal status on acute - , continuation - , and maintenance-phase treatment outcomes in patients with recurrent major depressive disorder ( MDD ) .
METHODS	This was a secondary analysis of data from the Prevention of Recurrent Episodes of Depression With Venlafaxine for Two Years ( PREVENT ) trial , a multiphase , multicenter , double-blind study in which adult outpatients with recurrent MDD ( by DSM-IV criteria ) were randomly assigned to 10 weeks of acute-phase venlafaxine extended release ( ER ) ( 75-300 mg/d ) or fluoxetine ( 20-60 mg/d ) .
METHODS	Patients achieving response or remission had 6 months of continuation-phase treatment .
METHODS	Responding or remitting patients in the venlafaxine ER group were randomly assigned to venlafaxine ER or placebo for 2 consecutive 12-month maintenance phases ; fluoxetine-treated patients continued receiving fluoxetine .
METHODS	The outcome measures for this analysis were acute - and continuation-phase response and remission rates ( as measured by the 17-item Hamilton Depression Rating Scale ) and time to depression recurrence in the maintenance phases according to sex and menopausal status at baseline .
RESULTS	The intent-to-treat population comprised 781 patients in the venlafaxine ER group ( 65 % women ) and 266 patients in the fluoxetine group ( 61 % women ) ; 64 % of all women were premenopausal , and 25 % were postmenopausal ( 5 % perimenopausal ; not analyzed ) .
RESULTS	At acute-phase end , remission rates in the venlafaxine ER vs fluoxetine groups were 44 % vs 47 % in men , 51 % vs 52 % in women , 50 % vs 52 % in premenopausal women , and 52 % vs 55 % in postmenopausal women .
RESULTS	At continuation-phase end , remission rates in the venlafaxine ER vs fluoxetine groups were 71 % vs 74 % in men , 72 % vs 67 % in women , 72 % vs 69 % in premenopausal women and 71 % vs 63 % in postmenopausal women .
RESULTS	Response rates were consistent with these findings .
RESULTS	Based on a Cox proportional hazards model , sex was not a significant predictor of recurrence during the first or second maintenance phase ( hazard ratio [ HR ] = 1.233 ; P = .3712 and HR = 1.103 ; P = .8075 , respectively ) , and neither was menopausal status at acute-phase baseline ( HR = 0.941 ; P = .8234 and HR = 0.531 ; P = .2065 , respectively ) .
CONCLUSIONS	In this study of patients with recurrent MDD , treatment outcomes with venlafaxine ER and fluoxetine did not differ on the basis of sex or menopausal status .
CONCLUSIONS	Our confidence in these findings is limited by the lack of a placebo arm during the acute and continuation phases and by the small sample sizes for subgroup analyses in the maintenance phases .
BACKGROUND	ClinicalTrials.gov identifier : NCT00046020 .

###24439186
OBJECTIVE	To assess the design and the Mainland China subgroup baseline characteristics of the study to evaluate the efficacy and safety of alogliptin versus placebo in subjects with type 2 diabetes ( T2DM ) as monotherapy , add-on to metformin or add-on to pioglitazone .
METHODS	This was a multi-center , randomized , double-blind , placebo-controlled , 16-week study comparing alogliptin ( ALO , 25 mg , 1/d ) versus placebo ( PLA ) as monotherapy ( A ) , add-on to metformin ( B ) or add-on to pioglitazone metformin ( C ) .
METHODS	The T2DM subjects with glycosylated hemoglobin A1c ( HbA1c ) between 7 % and 10 % and aged between 18 years and 75 years were enrolled and randomized to the alogliptin group and the placebo group in 1 : 1 ratio with 16 weeks treatment .
METHODS	All patients were followed up every 4 weeks .
METHODS	The safety endpoints consisted of the incidence of hypoglycemia and other adverse events .
RESULTS	A total of 491 patients were enrolled in the Mainland China subgroup of the study ( 181 in group A , 186 in group B and 124 in group C ) .
RESULTS	In each treatment group , the baseline characteristics including age , gender , body mass index , diabetes duration , HbA1c , fasting plasma glucose , body weight , daily dosage of metformin and daily dosage of pioglitazone were all well balanced .
CONCLUSIONS	The demographic data , medical history , glycemic profile and treatment regimen at baseline in Mainland China subgroup are well balanced .
CONCLUSIONS	The result of this study will provide the clinical evidence for the use of alogliptin in Chinese T2DM patients .

###24364801
OBJECTIVE	Behavioral activation ( BA ) is an empirically validated treatment that reduces depression by increasing overt behaviors and exposure to reinforcing environmental contingencies .
OBJECTIVE	Although research has identified an inverse correlation between pleasant or rewarding activities and depression , the causal relation between increased structured activities and reduced depression has not directly been studied .
METHODS	In the context of a recent randomized trial ( Hopko , Armento , et al. , 2011 ) , this study used longitudinal data and growth curve modeling to examine relationships among the quantity of activities completed , proportion of activities completed ( i.e. , therapeutic compliance ) , environmental reward , and depression in breast cancer patients treated with BA treatment for depression ( n = 23 ) .
RESULTS	Therapeutic compliance with assigned activities was causally related to depression reduction , whereas the specific quantity of completed activities was not systematically related .
RESULTS	Logistic regression indicated that for patients completing all assigned activities , treatment response and remission were achieved for all patients .
RESULTS	Neither therapeutic compliance nor the quantity of completed activities was directly associated with self-reported environmental reward during the BA interval ( Session 3 to posttreatment ) , and environmental reward did not mediate the relation between activation and depression .
CONCLUSIONS	Patient compliance with BA assignments is causally associated with depression reduction , whereas the quantity of completed activities is less relevant toward conceptualizing positive treatment outcome .
CONCLUSIONS	Study findings are discussed in the context of behavioral models of depression and BA therapy .

###25428509
OBJECTIVE	Our previous study , a 6-month randomised controlled trial , demonstrated that a group-based support promoted weight loss as compared to an education-only intervention .
OBJECTIVE	The purpose of this study was to examine weight loss maintenance for 2 years .
METHODS	Originally , 188 overweight Japanese adults , aged 40-65 years , were randomly assigned to 3 groups : control , education-only or group-based support .
METHODS	After the 6-month intervention , 125 participants in the education-only and the group-based support groups were followed up for 2 years .
METHODS	The primary outcome was the amount of weight lost .
METHODS	The participants were retrospectively grouped into quartiles of percent weight loss for secondary analyses .
RESULTS	At the end of follow-up , the amount of weight lost in the education-only and the group-based support groups was the same ( 3.3 kg ) .
RESULTS	Secondary analyses using data of those who completed the study ( n = 100 ) revealed that the participants in the highest quartile of percent weight loss significantly increased their step counts and moderate-to-vigorous physical activity compared with the lowest quartile .
RESULTS	No significant differences were observed in the energy intake among the four groups .
CONCLUSIONS	The effects of group-based support disappear within 2 years .
CONCLUSIONS	Increasing physical activity may be a crucial factor for successful maintenance of weight loss .

###25567131
OBJECTIVE	To date only a few randomized controlled studies have compared grafting strategies in patients with multi-vessel coronary disease .
OBJECTIVE	This study represents a pilot RCT designed to test the feasibility of a trial comparing conventional CABG performed with a LIMA-LAD plus saphenous vein grafts ( LIMA+SVG ) and CABG performed with total arterial grafting ( TAG ) .
METHODS	Consenting patients undergoing non-redo isolated CABG surgery at a single institution were randomized to TAG or LIMA+SVG groups .
METHODS	Exclusion criteria included prior CABG , emergent procedure , concomitant procedure , varicose veins and renal dysfunction .
METHODS	The primary endpoints were : enrolment > 20 % and completion of CT coronary angiography at 6 months > 80 % .
METHODS	Statistical investigation was performed on an intention to treat analysis .
RESULTS	Of 421 eligible patients , 60 were enrolled and 2 withdrew ( n = 30 in TAG , n = 28 LIMA+SVG ) for 14 % enrolment rate .
RESULTS	Patient characteristics were similar in each group .
RESULTS	No patients died in hospital and adverse events such as MI , stroke and deep sternal wound infection were not significantly different between groups .
RESULTS	Clinical follow-up was complete in 100 % of patients , with 44/58 ( 76 % ) undergoing CT coronary angio at 6 months .
RESULTS	Graft occlusion occurred in 2 patients in each group for patency rates of 89 % ( TAG ) and 91 % ( LIMA+SVG ) .
CONCLUSIONS	We provide evidence that an RCT comparing grafting strategy is possible but also show that achieving recruitment or follow-up CT may be difficult .
CONCLUSIONS	Given the excellent patency results and little difference between groups , our findings suggest that the sample size required may make it infeasible to compare graft patency at 6 months as a study end-point .
BACKGROUND	Randomized Controlled Trial number : ISRCTN80270323 .
BACKGROUND	Few RCT 's exist comparing conventional CABG performed with a LIMA-LAD plus saphenous vein grafts ( LIMA+SVG ) compared to CABG performed with total arterial grafting ( TAG ) .
BACKGROUND	This study is a pilot RCT designed to test the feasibility of such a trial and identify pitfalls .

###25609761
OBJECTIVE	We measured the long-term retention of knowledge gained through selected American Academy of Neurology annual meeting courses and compared the effects of repeated quizzing ( known as test-enhanced learning ) and repeated studying on that retention .
METHODS	Participants were recruited from 4 annual meeting courses .
METHODS	All participants took a pretest .
METHODS	This randomized , controlled trial utilized a within-subjects design in which each participant experienced 3 different postcourse activities with each activity performed on different material .
METHODS	Each key information point from the course was randomized in a counterbalanced fashion among participants to one of the 3 activities : repeated short-answer quizzing , repeated studying , and no further exposure to the materials .
METHODS	A final test covering all information points from the course was taken 5.5 months after the course .
RESULTS	Thirty-five participants across the 4 courses completed the study .
RESULTS	Average score on the pretest was 36 % .
RESULTS	Performance on the final test showed that repeated quizzing led to significantly greater long-term retention relative to both repeated studying ( 55 % vs 46 % ; t [ 34 ] = 3.28 , SEM = 0.03 , p = 0.01 , d = 0.49 ) and no further exposure ( 55 % vs 44 % ; t [ 34 ] = 3.16 , SEM = 0.03 , p = 0.01 , d = 0.58 ) .
RESULTS	Relative to the pretest baseline , repeated quizzing helped participants to retain almost twice as much of the knowledge acquired from the course compared to repeated studying or no further exposure .
CONCLUSIONS	Whereas annual meeting continuing medical education ( CME ) courses lead to long-term gains in knowledge , when repeated quizzing is added , retention is significantly increased .
CONCLUSIONS	CME planners may consider adding repeated quizzing to increase the impact of their courses .

###25267980
BACKGROUND	Methylene blue ( MB ) has been shown to be safe and effective against falciparum malaria in Africa and to have pronounced gametocytocidal properties .
METHODS	Three days of treatment with artesunate ( AS ) - amodiaquine ( AQ ) combined with MB was compared with AS-AQ treatment in a randomized controlled phase IIb study ; the study included 221 children aged 6-59 months with uncomplicated falciparum malaria in Burkina Faso .
METHODS	The primary end point was gametocyte prevalence during follow-up , as determined by microscopy and real-time quantitative nucleic acid sequence-based amplification ( QT-NASBA ) .
RESULTS	The gametocyte prevalence of Plasmodium falciparum at baseline was 3.6 % ( microscopy ) and 97 % ( QT-NASBA ) .
RESULTS	It was significantly lower in the AS-AQ-MB than in the AS-AQ group on day 7 of follow-up ( microscopy , 1.2 % vs 8.9 % [ P < .05 ] ; QT-NASBA , 36.7 % vs 63.3 % [ P < .001 ] ) .
RESULTS	Hemoglobin values were significantly lower in the AS-AQ-MB group than in the AS-AQ group at days 2 and 7 of follow-up .
RESULTS	Vomiting of the study medication occurred significantly more frequently in the AS-AQ-MB group .
CONCLUSIONS	The combination of MB with an artemisinin-based combination therapy has been confirmed to be effective against the gametocytes of P. falciparum .
CONCLUSIONS	MB-based combinations need to be compared with primaquine-based combinations , preferably using MB in an improved pediatric formulation .
CONCLUSIONS	Clinical Trials Registration : NCT01407887 .

###25226843
OBJECTIVE	To prospectively assess treatment response using volumetric functional magnetic resonance imaging ( MRI ) metrics in patients with hepatocellular carcinoma ( HCC ) treated with the combination of doxorubicin-eluting bead-transarterial chemoembolization ( DEB TACE ) and sorafenib .
METHODS	A single center study enrolled 41 patients treated with systemic sorafenib , 400 mg twice a day , combined with DEB TACE .
METHODS	All patients had a pre-treatment and 3-4 week post-treatment MRI .
METHODS	Anatomic response criteria ( RECIST , mRECIST and EASL ) and volumetric functional response ( ADC , enhancement ) were assessed .
METHODS	Statistical analyses included paired Student 's t-test , Kaplan-Meier curves , Cohen 's Kappa , and multivariate cox proportional hazard model .
RESULTS	Median tumour size by RECIST remained unchanged post-treatment ( 8.34.1 cm vs. 8.14.3 cm , p = 0.44 ) .
RESULTS	There was no significant survival difference for early response by RECIST ( p = 0.93 ) .
RESULTS	EASL and mRECIST could not be analyzed in 12 patients .
RESULTS	Volumetric ADC increased significantly ( 1.3210 ( -3 ) mm ( 2 ) / sec to 1.6010 ( -3 ) mm ( 2 ) / sec , p < 0.001 ) , and volumetric enhancement decreased significantly in HAP ( 38.2 % to 17.6 % , p < 0.001 ) and PVP ( 76.6 % to 41.2 % , p < 0.005 ) .
RESULTS	Patients who demonstrated 65 % decrease PVP enhancement had significantly improved overall survival compared to non-responders ( p < 0.005 ) .
CONCLUSIONS	Volumetric PVP enhancement was demonstrated to be significantly correlated with survival in the combination of DEB TACE and sorafenib for patients with HCC , enabling precise stratification of responders and non-responders .
CONCLUSIONS	PVP enhancement is significantly correlated with survival in responders ( p < 0.005 ) .
CONCLUSIONS	There was no significant survival difference for early response using RECIST ( p = 0.93 ) .
CONCLUSIONS	mRECIST or EASL could not assess tumour response in 29 % of patients .

###25662503
OBJECTIVE	To determine whether insulin delivered via a 4-mm 32-gauge pen needle ( PN ) provides equivalent glycemic control as 8-mm 31-gauge and 12.7-mm 29-gauge PNs in obese ( body mass index 30 ) patients with diabetes .
METHODS	This prospective , multicenter , randomized , open-label , 2-period , crossover , equivalence , home-based study was conducted from October 26 , 2010 , through May 31 , 2012 .
METHODS	After a 3-week wash-in period , eligible patients aged 18 to 80 years with a hemoglobin A1c ( HbA1c ) level of 5.5 % to 9.5 % ( 37-80 mmol/mol ) were randomized to compare either 4 - vs 8-mm PNs or 4 - vs 12.7-mm PNs , using each of the 2 assigned PNs for 12 weeks in random order .
METHODS	The primary outcome was change in HbA1c level , with equivalence limits of 0.4 % .
RESULTS	The 274 patients randomized ( mean SD age , 56.711.0 years ) had a mean SD body mass index of 37.06.1 ( range , 29.1-59 .9 ) and took up to 350 U of insulin daily ; 226 patients were included in the modified intention-to-treat analysis .
RESULTS	Mean ( 95 % CI ) changes in HbA1c levels with the 4-mm PN were -0.08 % ( -0.21 to 0.06 ) and -0.10 % ( -0.19 to 0.00 ) vs the 8 - and 12.7-mm PNs , respectively , within equivalence margins .
RESULTS	The 4-mm PN was less painful than the larger PNs ( P < .05 ) , with similar leakage rates reported ( 4.1 % -4.3 % ) .
RESULTS	Patients preferred the 4-mm PN over the 12.7-mm PN ( P < .05 ) but not significantly vs the 8-mm PN .
RESULTS	There were no differences between PNs in insulin doses and hypoglycemic or hyperglycemic adverse event rates .
CONCLUSIONS	The 4-mm 32-gauge PN provides equivalent glycemic control as 8 - and 12.7-mm PNs in obese patients with diabetes , with less pain and no increase in leakage .
CONCLUSIONS	Shorter PNs should be considered in all insulin-requiring patients with diabetes , including those who are obese .
BACKGROUND	clinicaltrials.gov Identifier : NCT01231984 .

###25269046
OBJECTIVE	External ventricular drainage ( EVD ) and lumbar drainage ( LD ) are the most widely used procedures for continued bloody cerebrospinal fluid drainage .
OBJECTIVE	Each has his own advantages and disadvantages .
OBJECTIVE	Here , we compared complications and clinical outcomes in patients with World Federation of Neurosurgical Societies ( WFNS ) grade III aneurysmal subarachnoid hemorrhage ( aSAH ) who underwent coil placement followed by EVD or LD .
METHODS	In this prospective , controlled study , all patients with aSAH classified as WFNS grade III who underwent coil placement at our institution were divided randomly into 2 groups : the EVD group and the LD group .
METHODS	The ratios of intracerebral hemorrhage , vasospasm , infection , duration of catheter placement , hydrocephalus , and Glasgow outcome scale ( GOS ) after 2 months of onset were analyzed between the 2 groups .
RESULTS	A total of 148 patients ( mean age 56.8 years ) were enrolled in this study .
RESULTS	Seventy-six patients were assigned to the EVD group , and 72 patients were assigned to the LD group .
RESULTS	The average time interval from stroke onset to surgery was 35.1 h. Compared with the EVD group , the LD group had a lower incidence of intracerebral hemorrhage , slightly higher rates of infection and hydrocephalus , and similar vasospasm and chronic hydrocephalus rates , durations of catheter placement , and GOS scores at 2 months after onset .
CONCLUSIONS	In order to improve the clinical outcomes of patients with aSAH , we suggest that LD is better than EVD for patients with WFNS grade III aSAH who underwent coil placement .

###25567713
OBJECTIVE	To investigate the effect of antibiotics on postoperative inflammatory complications after surgical extraction of the impacted mandibular third molar .
METHODS	Ninety-Six patients had their bilateral third molars removed through a split-mouth , double-blind , controlled , clinical trial in two visits .
METHODS	On one side amoxicillin ( or clindamycin ) was used ( antibiotics group ) from 1 h pre-operation to 3 d post-operation .
METHODS	On the other side , placebo was used ( placebo group ) the same time .
METHODS	Postoperative inflammatory complications including alveolar osteitis ( AO ) , surgical site infection ( SSI ) , pre-buccal site infection and anterior isthmus faucium space infection were monitored and recorded 2 d and 10 d after the surgery .
METHODS	The pain , swelling , and trismus were also recorded .
RESULTS	All 96 patients completed the study .
RESULTS	Two AO ( 2.1 % ) , one SSI ( 1.0 % ) and seven other infections were observed in the treatment group .
RESULTS	Also three AO ( 3.1 % ) , one SSI ( 1.0 % ) and eleven other infections were observed in the placebo group .
RESULTS	However , no statistically significant differences were found in the incidence of various postoperative inflammatory complications and reactions between the groups ( P > 0.05 ) .
RESULTS	There was no significant difference on the postoperative reaction , except pain on 10 d. Patients who had inflammatory infection recovered well with symptomatic anti-infection treatment .
CONCLUSIONS	The use of amoxicillin ( or clindamycin ) can not effectively prevent and reduce the postoperative inflammatory complications after surgical extraction of the impacted mandibular third molar .

###24889399
BACKGROUND	The identification of the cause of chronic low back pain ( CLBP ) represents a great challenge to orthopedists due to the controversy over the diagnosis of discogenic low back pain ( DLBP ) and the existence of a number of cases of CLBP of unknown origin .
BACKGROUND	This study aimed to develop diagnostic models to distinguish DLBP from other forms of CLBP and to identify serum biomarkers for DLBP .
METHODS	Serum samples were collected from patients with DLBP , chronic lumbar disc herniation ( LDH ) , or CLBP of unknown origin , and healthy controls ( N ) , and randomly divided into a training set ( n = 30 ) and a blind test set ( n = 30 ) .
METHODS	Matrix-assisted laser desorption ionization time-of-flight mass spectrometry was performed for protein profiling of these samples .
METHODS	After the discriminative ability of two most significantly differential peaks from each two groups was assessed using scatter plots , classification models were developed using differential peptide peaks to evaluate their diagnostic accuracy .
METHODS	The identity of peptides corresponding to three representative differential peaks was analyzed .
RESULTS	The fewest statistically significant differential peaks were identified between DLBP and CLBP ( 3 ) , followed by CLBP vs. N ( 5 ) , DLBP vs. N ( 9 ) , LDH vs. CLBP ( 20 ) , DLBP vs. LDH ( 23 ) , and LDH vs. N ( 43 ) .
RESULTS	The discriminative ability of two most significantly differential peaks was poor in classifying DLBP vs. CLBP but good in classifying DLBP vs. LDH .
RESULTS	The accuracy of models for classification of DLBP vs. CLBP was not very high in the blind test ( forecasting ability , 67.24 % ; sensitivity , 70 % ) , although a higher accuracy was observed for classification of DLBP vs. LDH and LDH vs. N ( forecasting abilities , ~ 90 % ; sensitivities , > 90 % ) .
RESULTS	A further investigation of three representative differential peaks led to the identification of two peaks as peptides of complement C3 , and one peak as a human fibrinogen peptide .
CONCLUSIONS	Our findings benefit not only the diagnosis of CLBP but also the understanding of the differences between different forms of DLBP .
CONCLUSIONS	The ability to distinguish between different causes of CLBP and the identification of serum biomarkers may be of great value to diagnose different causes of DLBP and predict treatment efficacy .

###24950523
OBJECTIVE	The aim of this study was to evaluate the cost-effectiveness of a home-based palliative care model relative to usual care in expediting discharge or enabling patients to remain at home .
METHODS	Economic evaluation of a pilot randomised controlled trial with 28 days follow-up .
METHODS	Mean costs and effectiveness were calculated for the Palliative Care Extended Packages at Home ( PEACH ) and usual care arms including : days at home ; place of death ; PEACH intervention costs ; specialist palliative care service use ; acute hospital and palliative care unit inpatient stays ; and outpatient visits .
RESULTS	PEACH mean intervention costs per patient ( $ 3489 ) were largely offset by lower mean inpatient care costs ( $ 2450 ) and in this arm , participants were at home for one additional day on average .
RESULTS	Consequently , PEACH is cost-effective relative to usual care when the threshold value for one extra day at home exceeds $ 1068 , or $ 2547 if only within-study days of hospital admission are costed .
RESULTS	All estimates are high uncertainty .
CONCLUSIONS	The results of this small pilot study point to the potential of PEACH as a cost-effective end-of-life care model relative to usual care .
CONCLUSIONS	Findings support the feasibility of conducting a definitive , fully powered study with longer follow-up and comprehensive economic evaluation .

###24536060
OBJECTIVE	Figitumumab is a human IgG2 monoclonal antibody targeting insulin-like growth factor 1 receptor ( IGF-1R ) , with antitumor activity in prostate cancer .
OBJECTIVE	This phase II trial randomized chemotherapy-nave men with progressing castration-resistant prostate cancer to receive figitumumab every 3 weeks with docetaxel/prednisone ( Arm A ) or docetaxel/prednisone alone ( Arm B1 ) .
OBJECTIVE	At progression on Arm B1 , patients could cross over to the combination ( Arm B2 ) .
METHODS	Prostate-specific antigen ( PSA ) response was the primary endpoint ; response assessment on the two arms was noncomparative and tested separately ; H0 = 0.45 versus HA = 0.60 ( = 0.05 ; = 0.09 ) for Arm A ; H0 = 0.05 versus HA = 0.20 ( = 0.05 , = 0.10 ) for Arm B2 .
METHODS	A comparison of progression-free survival ( PFS ) on Arms A and B1 was planned .
RESULTS	A total of 204 patients were randomized and 199 treated ( Arm A : 97 ; Arm B1 : 102 ) ; 37 patients crossed over to Arm B2 ( median number of cycles started : Arm A = 8 ; B1 = 8 ; B2 = 4 ) .
RESULTS	PSA responses occurred in 52 % and 60 % of Arms A and B1 , respectively ; the primary PSA response objective in Arm A was not met .
RESULTS	Median PFS was 4.9 and 7.9 months , respectively ( HR = 1.44 ; 95 % confidence interval , 1.06-1 .96 ) .
RESULTS	PSA response rate was 28 % in Arm B2 .
RESULTS	The figitumumab combination appeared more toxic , with more treatment-related grade 3/4 adverse events ( 75 % vs. 56 % ) , particularly hyperglycemia , diarrhea , and asthenia , as well as treatment-related serious adverse events ( 41 % vs. 15 % ) , and all-causality grade 5 adverse events ( 18 % vs. 8 % ) .
CONCLUSIONS	IGF-1R targeting may merit further evaluation in this disease in selected populations , but combination with docetaxel is not recommended .

###24742124
BACKGROUND	Central obesity in polycystic ovary syndrome ( PCOS ) is associated with increased inflammatory markers and increased risk for type 2 diabetes .
OBJECTIVE	The objective of the study was to evaluate whether treatment with metformin ( M ) or M combined with oral contraceptive pills ( OCPs ) resulted in a more advantageous body composition than treatment with OCP alone .
METHODS	The study was conducted at an outpatient clinic .
METHODS	This was a randomized , controlled clinical trial .
METHODS	Ninety patients with PCOS were randomized to 12 months ' treatment with M ( 2 g/d ) , M + OCP ( 150 mg desogestrel +30 g ethinylestradiol ) , or OCP .
METHODS	Whole-body dual-energy x-ray absorptiometry scans and clinical and hormonal evaluations were performed before and after the intervention period .
METHODS	A total of 65 of 90 patients completed the study .
METHODS	Changes in weight at 6 and 12 months and changes in regional fat mass estimates at 12 months were measured .
RESULTS	Dropout rates between intervention groups were not significantly different .
RESULTS	Treatment with M and M+OCP were superior to OCP regarding weight and regional fat mass .
RESULTS	The median ( quartiles ) weight changes during 12 months of M , M+OCP , and OCP treatment were -3.0 ( -10.3 ; 0.6 ) , -1.9 ( -4.9 ; 0.1 ) , and 1.2 ( -0.8 ; 3.0 ) kg , respectively , P < .05 .
RESULTS	Upper to lower fat mass ratio was unchanged .
RESULTS	Changes in body composition were predicted by the type of medical intervention ( M , M+OCP , or OCP ) and not by body mass index at study inclusion .
RESULTS	OCP and M+OCP were superior to M regarding reduction in free T levels .
CONCLUSIONS	M treatment alone or in combination with OCP was associated with weight loss and improved body composition compared with OCP , whereas free T levels decreased during M+OCP or OCP .
CONCLUSIONS	Combined treatment with M+OCP should be considered as an alternative to treatment with OCP alone to avoid weight gain in PCOS .

###24427795
OBJECTIVE	To compare visual acuity , intraocular lens ( IOL ) movement , and depth of focus with the Crystalens HD single-optic accommodating IOL and the Tecnis ZCB00 aspheric monofocal IOL .
METHODS	St. Thomas ' Hospital , London , United Kingdom .
METHODS	Prospective randomized controlled trial .
METHODS	Patients with bilateral symptomatic cataract had bilateral sequential cataract surgery within 6 weeks with randomized implantation of the accommodating or monofocal IOL in both eyes .
METHODS	Exclusion criteria included other ocular conditions and corneal astigmatism greater than 2.00 diopters .
METHODS	The primary outcome was uniocular distance-corrected near visual acuity ( DCNVA ) .
METHODS	Secondary measures were IOL movement , depth of focus , intermediate and distance vision , objective refraction , and pupil size at distance and near fixation .
METHODS	Results from 3 months postoperatively are presented .
RESULTS	Three months postoperatively , 64 patients ( 32 in each group ) were available for study .
RESULTS	The distance vision was not statistically significantly different between the accommodating IOL and monofocal IOL ( mean 0.05 logMAR versus 0.06 logMAR ) .
RESULTS	The mean DCNVA ( 0.48 logMAR 0.15 [ SD ] versus 0.61 0.13 logMAR ) and intermediate visual acuity ( 0.08 0.1 logMAR versus 0.20 0.09 logMAR ) were significantly better with the accommodating IOL ( P < .001 ) .
RESULTS	Neither IOL had clinically significant movement , and near vision did not directly correlate with movement of the accommodating IOL .
RESULTS	The accommodating IOL provided greater depth of focus .
CONCLUSIONS	Near and intermediate acuities were better with the accommodating IOL .
CONCLUSIONS	This effect was not directly linked to IOL movement but was at least partly due to depth of focus .

###25740286
BACKGROUND	Whether addition of fluorouracil to epirubicin , cyclophosphamide , and paclitaxel ( EC-P ) is favourable in adjuvant treatment of patients with node-positive breast cancer is controversial , as is the benefit of increased density of dosing .
BACKGROUND	We aimed to address these questions in terms of improvements in disease-free survival .
METHODS	In this 22 factorial , open-label , phase 3 trial , we enrolled patients aged 18-70 years with operable , node positive , early-stage breast cancer from 81 Italian centres .
METHODS	Eligible patients were randomly allocated in a 1:1:1:1 ratio with a centralised , interactive online system to receive either dose-dense chemotherapy ( administered intravenously every 2 weeks with pegfilgrastim support ) with fluorouracil plus EC-P ( FEC-P ) or EC-P or to receive standard-interval chemotherapy ( administered intravenously every 3 weeks ) with FEC-P or EC-P .
METHODS	The primary study endpoint was disease-free survival , assessed with the Kaplan-Meier method in the intention-to-treat population .
METHODS	Our primary comparisons were between dose schedule ( every 2 weeks vs every 3 weeks ) and dose type ( FEC-P vs EC-P ) .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00433420 .
RESULTS	Between April 24 , 2003 , and July 3 , 2006 , we recruited 2091 patients .
RESULTS	88 patients were enrolled in centres that only provided standard-intensity dosing .
RESULTS	After a median follow-up of 70 years ( interquartile range [ IQR ] 45-63 ) , 140 ( 26 % ) of 545 patients given EC-P every 3 weeks , 157 ( 29 % ) of 544 patients given FEC-P every 3 weeks , 111 ( 22 % ) of 502 patients given EC-P every 2 weeks , and 113 ( 23 % ) of 500 patients given FEC-P every 2 weeks had a disease-free survival event .
RESULTS	For the dose-density comparison , disease-free survival at 5 years was 81 % ( 95 % CI 79-84 ) in patients treated every 2 weeks and 76 % ( 74-79 ) in patients treated every 3 weeks ( HR 077 , 95 % CI 065-092 ; p = 0004 ) ; overall survival rates at 5 years were 94 % ( 93-96 ) and 89 % ( 87-91 ; HR 065 , 051-084 ; p = 0001 ) and for the chemotherapy-type comparison , disease-free survival at 5 years was 78 % ( 75-81 ) in the FEC-P groups and 79 % ( 76-82 ) in the EC-P groups ( HR 106 , 089-125 ; p = 0561 ) ; overall survival rates at 5 years were 91 % ( 89-93 ) and 92 % ( 90-94 ; 116 , 091-146 ; p = 0234 ) .
RESULTS	Compared with 3 week dosing , chemotherapy every 2 weeks was associated with increased rate of grade 3-4 of anaemia ( 14 [ 14 % ] of 988 patients vs two [ 02 % ] of 984 patients ; p = 0002 ) ; transaminitis ( 19 [ 19 % ] vs four [ 04 % ] ; p = 0001 ) , and myalgias ( 31 [ 31 % ] vs 16 [ 16 % ] ; p = 0019 ) , and decreased rates of grade 3-4 neutropenia ( 147 [ 149 % ] vs 433 [ 440 % ] ; p < 00001 ) .
RESULTS	Addition of fluorouracil led to increased rates of grade 3-4 neutropenia ( 354 [ 345 % ] of 1025 patients on FEC-P vs 250 [ 242 % ] of 1032 patients on EC-P ; p < 00001 ) , fever ( nine [ 09 % ] vs two [ 02 % ] ) , nausea ( 47 [ 46 % ] vs 28 [ 27 % ] ) , and vomiting ( 32 [ 31 % ] vs 15 [ 14 % ] ) .
CONCLUSIONS	In patients with node-positive early breast cancer , dose-dense adjuvant chemotherapy improved disease-free survival compared with standard interval chemotherapy .
CONCLUSIONS	Addition of fluorouracil to a sequential EC-P regimen was not associated with an improved disease-free survival outcome .
BACKGROUND	Bristol-Myers Squibb , Pharmacia , and Domp Biotec .

###26258613
OBJECTIVE	We present and validate a multivariate model that partially compensates for retinal nerve fiber layer ( RNFL ) intersubject variability .
METHODS	A total of 202 healthy volunteers randomly attributed to a training ( TS ) and a validation ( VS ) sample underwent complete ophthalmic examination , including Fourier-domain optical coherence tomography ( FD-OCT ) .
METHODS	We acquired FD-OCT data centered at the optic disc ( OD ) and the macula .
METHODS	Two-dimensional ( 2D ) projection images were computed and registered , to determine the distance between fovea and OD centers ( FD ) and their respective angle ( FA ) .
METHODS	Retinal vessels were automatically segmented in the projection images and used to calculate the circumpapillary retinal vessel density ( RVD ) profile .
METHODS	Using the TS , a multivariate model was calculated for each of 256 sectors of the RNFL , including OD ratio , orientation and area , RVD , FD , FA , age , and refractive error .
METHODS	Model selection was based on Akaike Information Criteria .
METHODS	The compensation effect was determined for 12 clock hour sectors , comparing the coefficients of variation ( CoV ) of measured and model-compensated RNFL thicknesses .
METHODS	The model then was applied to the VS , and CoV was calculated .
RESULTS	The R value for the multivariate model was , on average 0.57 ( max = 0.68 ) .
RESULTS	Compensation reduced the CoV on average by 18 % , both for the TS and VS ( up to 23 % and 29 % ) , respectively .
CONCLUSIONS	We have developed and validated a comprehensive multivariate model that may be used to create a narrower range of normative RNFL data , which could improve diagnostic separation between early glaucoma and healthy subjects .
CONCLUSIONS	This , however , remains to be demonstrated in future studies .

###25523430
BACKGROUND	ACTION , a 24-week , prospective , randomized , parallel-group , double-blind study in patients with severe Alzheimer 's disease ( AD ) , demonstrated significant efficacy of 13.3 mg/24 h versus 4.6 mg/24 h rivastigmine patch on the Severe Impairment Battery ( SIB ) and Alzheimer 's Disease Cooperative Study-Activities of Daily Living scale-Severe Impairment Version ( ADCS-ADL-SIV ) .
BACKGROUND	Overall , 61 % of the study population received at least 1 dose of concomitant memantine , regardless of dose or duration .
BACKGROUND	This retrospective analysis investigated the effects of concomitant memantine on the efficacy , safety and tolerability of 13.3 mg/24 h versus 4.6 mg/24 h rivastigmine patch .
METHODS	Patients were stratified according to whether or not they received at least one dose of concomitant memantine during the double-blind phase .
METHODS	Changes from baseline on the SIB and ADCS-ADL-SIV were compared using analysis of covariance ( ANCOVA ) with treatment , pooled center , memantine usage and treatment-by-memantine as factors , and baseline as a covariate .
METHODS	Safety and tolerability were assessed .
RESULTS	Memantine-treated patients were younger than those not receiving memantine ( mean 75.9 and 78.8 years , respectively ) , with a lower screening Mini-Mental State Examination ( 8.6 and 9.2 , respectively ) .
RESULTS	ANCOVA confirmed there was no significant interaction ( p > 0.1 ) between study treatment and memantine use on the SIB or ADCS-ADL-SIV .
RESULTS	The incidence of adverse events was : 71.4 % , 13.3 mg/24 h patch with memantine ; 79.7 % , 13.3 mg/24 h patch alone ; 74.7 % , 4.6 mg/24 h patch with memantine ; and 71.1 % , 4.6 mg/24 h patch alone .
CONCLUSIONS	These data suggest benefit of 13.3 mg/24 h versus 4.6 mg/24 h rivastigmine patch , regardless of concomitant memantine use .
CONCLUSIONS	The incidence of adverse events with highdose patch was similar in memantine-treated patients and those not receiving memantine .

###25445827
BACKGROUND	Childhood asthma morbidity remains significant , especially in low-income children .
BACKGROUND	Most often , asthma management is provided by the child 's primary care provider .
OBJECTIVE	We sought to evaluate whether enhancing primary care management for persistent asthma with telephone-based peer coaching for parents reduced asthma impairment and risk in children 3 to 12 years old .
METHODS	Over 12 months , peer trainers provided parents with asthma management training by telephone ( median , 18 calls ) and encouraged physician partnership .
METHODS	The intervention was evaluated in a cluster-randomized trial of 11 intervention and 11 usual care pediatric practices ( 462 and 486 families , respectively ) .
METHODS	Patient outcomes were assessed by means of telephone interviews at 12 and 24 months conducted by observers blinded to intervention assignment and compared by using mixed-effects models , controlling for baseline values and clustering within practices .
METHODS	In a planned subgroup analysis we examined the heterogeneity of the intervention effect by insurance type ( Medicaid vs other ) .
RESULTS	After 12 months , intervention participation resulted in 20.9 ( 95 % CI , 9.1-32 .7 ) more symptom-free days per child than in the control group , and there was no difference in emergency department ( ED ) visits .
RESULTS	After 24 months , ED visits were reduced ( difference in mean visits/child , -0.28 ; 95 % CI , -0.5 to -0.02 ) , indicating a delayed intervention effect .
RESULTS	In the Medicaid subgroup , after 12 months , intervention participation resulted in 42 % fewer ED visits ( difference in mean visits/child , -0.50 ; 95 % CI , -0.81 to -0.18 ) and 62 % fewer hospitalizations ( difference in mean hospitalizations/child , -0.16 ; 95 % CI , -0.30 to -0.014 ) .
RESULTS	Reductions in health care use endured through 24 months .
CONCLUSIONS	This pragmatic telephone-based peer-training intervention reduced asthma impairment .
CONCLUSIONS	Asthma risk was reduced in children with Medicaid insurance .

###25619263
BACKGROUND	The Study to Assess Long-term Opioid Medication Effectiveness ( SALOME ) is a two-stage phase III , single site ( Vancouver , Canada ) , randomized , double blind controlled trial designed to test if hydromorphone is as effective as diacetylmorphine for the treatment of long-term illicit opioid injection .
BACKGROUND	Recruiting participants for clinical trials continues to be a challenge in medical and addiction research , with many studies not being able to reach the planned sample size in a timely manner .
BACKGROUND	The aim of this study is to describe the recruitment strategies in SALOME , which offered appealing treatments but had limited clinic capacity and no guaranteed post-trial continuation of the treatments .
METHODS	SALOME included chronic opioid-dependent , current illicit injection opioid users who had at least one previous episode of opioid maintenance treatment .
METHODS	Regulatory approvals were received in June 2011 and recruitment strategies were implemented over the next 5 months .
METHODS	Recruitment strategies included ongoing open communication with the community , a consistent and accessible team and participant-centered screening .
METHODS	All applicants completed a pre-screening checklist to assess prerequisites .
METHODS	Applicants meeting these prerequisites were later contacted to commence the screening process .
RESULTS	A total of 598 applications were received over the two-year recruitment period ; 130 were received on the first day of recruitment .
RESULTS	Of these applicants , 485 met prerequisites ; however , many could not be found or were not reached before recruitment ended .
RESULTS	For the 253 candidates who initiated the screening process , the average time lapse between application and screening date was 8.3 months ( standard deviation [ SD ] = 4.44 ) and for the 202 randomized to the study , the average processing time from initial screen to randomization was 25.9 days ( SD = 37.48 ; Median = 15.0 ) .
CONCLUSIONS	As in prior trials offering injectable diacetylmorphine within a supervised model , recruiting participants for this study took longer than planned .
CONCLUSIONS	The recruitment challenges overcome in SALOME were due to the high number of applicants compared with the limited number that could be randomized and treated .
CONCLUSIONS	Our study emphasizes the value of integrating these strategies into clinical addiction research to overcome study-specific barriers .
BACKGROUND	ClinicalTrials.gov : NCT01447212 .

###25920634
OBJECTIVE	To compare a single leukocyte-poor ( type-4B ) platelet-rich plasma ( PRP ) injection versus bupivacaine injection for recalcitrant lateral epicondylar tendinopathy ( LET ) .
METHODS	25 patients aged 27 to 50 years with painful and recalcitrant LET of the humerus were randomised to receive leukocyte-poor ( type-4B ) PRP ( n = 15 ) or bupivacaine ( n = 10 ) injection .
METHODS	Outcome measures included visual analogue scale ( VAS ) for pain , modified Mayo clinic performance index for elbow ( MMCPIE ) for elbow function , and Nirschl score for activity-related pain at 1 , 3 , 6 , and 12 months by a single assessor .
RESULTS	At baseline , the PRP and bupivacaine groups were comparable in terms of age , sex , duration of symptoms , VAS for pain , MMCPIE score , and Nirschl score .
RESULTS	After one month , the percentage of improvement was less in the PRP than bupivacaine group in terms of the VAS for pain ( 17.7 % vs. 26.5 % ) , MMCPIE score ( 24.0 % vs. 27.6 % ) , and Nirschl score ( 20.7 % vs. 31.1 % ) .
RESULTS	Nonetheless , improvement in the respective scores was greater in the PRP than bupivacaine group after 3 months ( 42.5 % vs. 30.9 % , 34.1 % vs. 27.2 % , and 50.7 % vs. 39.6 % ) , 6 months ( 67.3 % vs. 20.1 % , 40.6 % vs. 16.3 % , and 71.4 % vs. 31.1 % ) , and one year ( 83.2 % vs. 45.6 % , 47.0 % vs. 21.7 % , and 76.6 % vs. 56.3 % ) .
RESULTS	The differences in scores between groups were significant at 6 months and one year only ( p < 0.001 ) .
CONCLUSIONS	Leukocyte-poor ( type-4 ) PRP injection for recalcitrant LET enabled good improvement in pain and function .

###24308874
BACKGROUND	Smoking cessation is a high-priority intervention to prevent CVD events and deaths in developing countries .
BACKGROUND	While several interventions to stop smoking have been proved successful , the question of how to increase their effectiveness and practicality in developing countries remains .
BACKGROUND	In this study , a newly devised evidence-based smoking cessation service package will be compared with the existing service in a randomized controlled trial within the community setting of Thailand .
METHODS	This randomized control trial will recruit 440 current smokers at CVD risk because of being diabetic and/or hypertensive .
METHODS	Informed , consented participants will be randomly allocated into the new service-package arm and the routine service arm .
METHODS	The study will take place in the non-communicable disease clinics of the Maetha District Hospital , Lampang , northern Thailand .
METHODS	The new smoking-cessation service-package comprises ( 1 ) regular patient motivation and coaching from the same primary care nurse over a 3-month period ; ( 2 ) monthly application of piCO + smokerlyzer to sustain motivation of smoker 's quitting attempt and provide positive feedback over a 3-month period ; ( 3 ) assistance by an assigned family member ; ( 4 ) nicotine replacement chewing gum to relieve withdrawal symptoms .
METHODS	This new service will be compared with the traditional routine service comprising the 5A approach in a 1-year follow-up .
METHODS	Participants who consent to participate in the study but refuse to attempt quitting smoking will be allocated to the non-randomized arm , where they will be just followed up and monitored .
METHODS	Primary outcome of the study is smoking cessation rate at 1-year follow-up proven by breath analysis measuring carbomonoxide in parts per million in expired air .
METHODS	Secondary outcomes are smoking cessation rate at the 6-month follow-up , blood pressure and heart rate , CVD risk according to the Framingham general cardiovascular risk score , CVD events and deaths at the 12-month follow-up , and the cost-effectiveness of the health service packages .
METHODS	Intention-to-treat analysis will be followed .
METHODS	Factors influencing smoking cessation will be analyzed by the structure equation model .
CONCLUSIONS	This multicomponent intervention , accessible at primary healthcare clinics , and focusing on the individual as well as the family and social environment , is unique and expected to work effectively .
BACKGROUND	Current Controlled Trials ISRCTN89315117 .

###24434073
BACKGROUND	Facing frequent stigma and discrimination , many people with mental illness have to choose between secrecy and disclosure in different settings .
BACKGROUND	Coming Out Proud ( COP ) , a 3-week peer-led group intervention , offers support in this domain in order to reduce stigma 's negative impact .
OBJECTIVE	To examine COP 's efficacy to reduce negative stigma-related outcomes and to promote adaptive coping styles ( Current Controlled Trials number : ISRCTN43516734 ) .
METHODS	In a pilot randomised controlled trial , 100 participants with mental illness were assigned to COP or a treatment-as-usual control condition .
METHODS	Outcomes included self-stigma , empowerment , stigma stress , secrecy and perceived benefits of disclosure .
RESULTS	Intention-to-treat analyses found no effect of COP on self-stigma or empowerment , but positive effects on stigma stress , disclosure-related distress , secrecy and perceived benefits of disclosure .
RESULTS	Some effects diminished during the 3-week follow-up period .
CONCLUSIONS	Coming Out Proud has immediate positive effects on disclosure - and stigma stress-related variables and may thus alleviate stigma 's negative impact .

###26290088
BACKGROUND	Highly cross-linked polyethylene infused with vitamin E ( E-poly ) was developed to increase oxidative resistance without affecting mechanical properties .
BACKGROUND	We evaluated this type of polyethylene in a randomized clinical study that used radiostereometric analysis .
BACKGROUND	Our objective was to compare the early-term femoral head penetration of an E-poly liner with that of a heat-treated polyethylene liner , ArComXL .
BACKGROUND	We hypothesized that the clinical outcome at two years following total hip arthroplasty would be unaffected by the choice of polyethylene .
METHODS	In this prospective study , sixty-one patients ( seventy hips ) with noninflammatory hip osteoarthritis and a median age of fifty-eight years were randomized to receive either an implant with an E-Poly or a heat-treated highly cross-linked polyethylene liner .
METHODS	The patients were followed for two years and evaluated at three time points ( three months , one year , and two years ) .
RESULTS	The median proximal penetration in the E-poly group increased from 0.04 mm at three months to 0.06 mm at two years of follow-up .
RESULTS	Corresponding values for the ArComXL group were 0.03 mm and 0.10 mm .
RESULTS	In both groups , significantly increased penetration was observed between three months and two years ( E-poly , p = 0.02 ; ArComXL , p < 0.001 ) , but between one and two years , the increase was significant only in the control group ( E-poly , p = 0.23 ; ArComXL , p = 0.002 ) .
CONCLUSIONS	The femoral head penetration of E-poly was very low at two years .
CONCLUSIONS	Whether the increase observed between three months and two years was caused by creep , deformation , wear , or a combination of these can not be determined by our study .
CONCLUSIONS	There were no significant differences observed in femoral head penetration rates between E-poly and ArComXL .
CONCLUSIONS	Currently , the theoretical advantages of E-poly remain to be confirmed .

###24429537
BACKGROUND	trans Palmitoleic acid ( t-16 :1 n-7 , or 16:1 t9 in the nomenclature usually applied to trans fatty acids and used herein ) arouses great scientific interest because it has been suggested to serve as a biomarker for lower risks of type 2 diabetes and coronary artery disease .
OBJECTIVE	Although 16:1 t9 has been assumed to derive from dietary sources , we examined the hypothesis that 16:1 t9 might also be endogenously produced from its metabolic precursor vaccenic acid ( t-18 :1 n-7 or 18:1 t11 ) .
METHODS	We reevaluated fatty acid data obtained from one human intervention study and one cellular model in both of which 18:1 t11 was supplemented .
METHODS	Both studies have already been published , but to our knowledge , 16:1 t9 has not yet been considered .
METHODS	This reanalysis of the datasets was reasonable because a new methodology for identifying 16:1 cis and trans isomers allowed us to address the subject presented in this article .
RESULTS	Data showed that the systemic or intracellular increase in 16:1 t9 was strongly correlated with the increase in 18:1 t11 after the dietary intake or cellular uptake of 18:1 t11 .
RESULTS	The conversion rate in humans was , on average , 17 % .
CONCLUSIONS	Our findings suggest that endogenous 16:1 t9 is not , as has been assumed , exclusively diet derived but may also be produced by the partial oxidation of dietary 18:1 t11 .

###24452701
OBJECTIVE	To determine the effectiveness of personal digital assistant devices on achievement of memory and organization goals in patients with poor memory after acquired brain injury .
METHODS	Assessor blinded randomized controlled trial .
METHODS	Specialist brain injury rehabilitation hospital ( inpatients and outpatients ) .
METHODS	Adults with acquired brain impairments ( 85 % traumatic brain injury ; aged 17 years ) who were assessed as having functional memory impairment on the Rivermead Behavioural Memory Test ( General Memory Index ) .
METHODS	Training and support to use a personal digital assistant for eight weeks to compensate for memory failures by an occupational therapist .
METHODS	The control intervention was standard rehabilitation , including use of non-electronic memory aids .
METHODS	Goal Attainment Scale which assessed achievement of participants ' daily memory functioning goals and caregiver perception of memory functioning ; and General Frequency of Forgetting subscale of the Memory Functioning Questionnaire administered at baseline ( pre-randomization ) and post intervention ( eight weeks later ) .
RESULTS	Forty-two participants with memory impairment were recruited .
RESULTS	Use of a personal digital assistant led to greater achievement of functional memory goals ( mean difference 1.6 ( 95 % confidence interval ( CI ) 1.0 to 2.2 ) , P = 0.0001 ) and improvement on the General Frequency of Forgetting subscale ( mean difference 12.5 ( 95 % CI 2.0 to 22.9 ) , P = 0.021 ) .
CONCLUSIONS	Occupational therapy training in the use of a handheld computer improved patients ' daily memory function more than standard rehabilitation .

###24477186
BACKGROUND	In searching for an optimal induction regimen , we conducted two separate randomized trials of 38 living donor and 90 deceased donor adult , primary kidney transplant recipients comparing antithymocyte globulin ( Thymoglobulin ) ( group A , N = 43 ) versus alemtuzumab ( group B , N = 43 ) versus daclizumab ( group C , N = 42 ) , using exactly the same three treatment arms in each trial .
METHODS	For the purpose of maximizing statistical power , results from the two randomized trials were combined .
METHODS	Groups A and C received standard maintenance dosing with tacrolimus ( TAC ) , mycophenolate mofetil ( MMF ) , and corticosteroids .
METHODS	Because of intense lymphodepletion expected with alemtuzumab use ( and hoped-for achievement of a truer immunoregulatory state ) , group B received lower TAC and MMF dosing and corticosteroid avoidance .
METHODS	Long-term target TAC trough level and MMF dosing were 5 to 7 ng/mL and 1,000 mg b.i.d. in groups A and C ; 4 to 6 ng/mL and 500 mg b.i.d. in group B.
RESULTS	With median follow-up of 95 months , biopsy-proven cute rejection incidence was similar in the three groups ( 8/43 , 14/43 , and 12/42 , P = 0.34 ) , but biopsy-proven chronic allograft injury incidence was significantly higher in group B ( 19/43 ) in comparison with groups A ( 9/43 ) and C ( 7/42 ) combined ( P = 0.0008 ) .
RESULTS	Mean calculated creatinine clearance was significantly lower in group B versus the average of groups A and C means throughout 60 months posttransplant ( 62.94.2 vs. 83.66.9 and 79.85.9 at 60 months , P = 0.01 ) , and death-censored graft failure was significantly higher in group B ( 13/43 ) versus groups A ( 5/43 ) and C ( 5/42 ) combined ( P = 0.009 ) .
RESULTS	Total infection and new-onset diabetes after transplant rates were not significantly different .
RESULTS	Ad hoc analysis suggested that the inferior results in group B were specifically a result of reduced dosing and greater withholding of TAC and MMF occurring in that group .
CONCLUSIONS	Long-term results clearly indicate inferior clinical outcomes in group B.

###24384083
BACKGROUND	In the past , bilateral contralateral routing of signals ( BICROS ) amplification incorporated omnidirectional microphones on the transmitter and receiver sides and some models utilized noise reduction ( NR ) on the receiver side .
BACKGROUND	Little research has examined the performance of BICROS amplification in background noise .
BACKGROUND	However , previous studies examining contralateral routing of signals ( CROS ) amplification have reported that the presence of background noise on the transmitter side negatively affected speech recognition .
BACKGROUND	Recently , NR was introduced as a feature on the receiver and transmitter sides of BICROS amplification , which has the potential to decrease the impact of noise on the wanted speech signal by decreasing unwanted noise directed to the transmitter side .
OBJECTIVE	The primary goal of this study was to examine differences in the reception threshold for sentences ( RTS in dB ) using the Hearing in Noise Test ( HINT ) in a diffuse listening environment between unaided and three aided BICROS conditions ( no NR , mild NR , and maximum NR ) in the Tandem 16 BICROS .
OBJECTIVE	A secondary goal was to examine real-world subjective impressions of the Tandem 16 BICROS compared to unaided .
METHODS	A randomized block repeated measures single blind design was used to assess differences between no NR , mild NR , and maximum NR listening conditions .
METHODS	Twenty-one adult participants with asymmetric sensorineural hearing loss ( ASNHL ) and experience with BICROS amplification were recruited from Washington University in St. Louis School of Medicine .
METHODS	Participants were fit with the National Acoustic Laboratories ' Nonlinear version 1 prescriptive target ( NAL-NL1 ) with the Tandem 16 BICROS at the initial visit and then verified using real-ear insertion gain ( REIG ) measures .
METHODS	Participants acclimatized to the Tandem 16 BICROS for 4 wk before returning for final testing .
METHODS	Participants were tested utilizing HINT sentences examining differences in RTS between unaided and three aided listening conditions .
METHODS	Subjective benefit was determined via the Abbreviated Profile of Hearing Aid Benefit ( APHAB ) questionnaire between the Tandem 16 BICROS and unaided .
METHODS	A repeated measures analysis of variance ( ANOVA ) was utilized to analyze the results of the HINT and APHAB .
RESULTS	Results revealed no significant differences in the RTS between unaided , no NR , mild NR , and maximum NR .
RESULTS	Subjective impressions using the APHAB revealed statistically and clinically significant benefit with the Tandem 16 BICROS compared to unaided for the Ease of Communication ( EC ) , Background Noise ( BN ) , and Reverberation ( RV ) subscales .
CONCLUSIONS	The RTS was not significantly different between unaided , no NR , mild NR , and maximum NR .
CONCLUSIONS	None of the three aided listening conditions were significantly different from unaided performance as has been reported for previous studies examining CROS hearing aids .
CONCLUSIONS	Further , based on comments from participants and previous research studies with conventional hearing aids , manufacturers of BICROS amplification should consider incorporating directional microphones and independent volume controls on the receiver and transmitter sides to potentially provide further improvement in signal-to-noise ratio ( SNR ) for patients with ASNHL .

###25682778
OBJECTIVE	To determine the effectiveness of a client or care-provider strategy to improve the implementation of external cephalic version .
METHODS	Cluster randomized controlled trial .
METHODS	Twenty-five clusters ; hospitals and their referring midwifery practices randomly selected in the Netherlands .
METHODS	Singleton breech presentation from 32 weeks of gestation onwards .
METHODS	We randomized clusters to a client strategy ( written information leaflets and decision aid ) , a care-provider strategy ( 1-day counseling course focused on knowledge and counseling skills ) , a combined client and care-provider strategy and care-as-usual strategy .
METHODS	We performed an intention-to-treat analysis .
METHODS	Rate of external cephalic version in various strategies .
METHODS	Secondary outcomes were the percentage of women counseled and opting for a version attempt .
RESULTS	The overall implementation rate of external cephalic version was 72 % ( 1169 of 1613 eligible clients ) with a range between clusters of 8-95 % .
RESULTS	Neither the client strategy ( OR 0.8 , 95 % CI 0.4-1 .5 ) nor the care-provider strategy ( OR 1.2 , 95 % CI 0.6-2 .3 ) showed significant improvements .
RESULTS	Results were comparable when we limited the analysis to those women who were actually offered intervention ( OR 0.6 , 95 % CI 0.3-1 .4 and OR 2.0 , 95 % CI 0.7-4 .5 ) .
CONCLUSIONS	Neither a client nor a care-provider strategy improved the external cephalic version implementation rate for breech presentation , neither with regard to the number of version attempts offered nor the number of women accepting the procedure .

###25888114
BACKGROUND	Balance dysfunction after stroke limits patients ' general function and participation in daily life .
BACKGROUND	Previous researches have suggested that Tai Chi exercise could offer a positive improvement in older individuals ' balance function and reduce the risk of falls .
BACKGROUND	But convincing evidence for the effectiveness of enhancing balance function after stroke with Tai Chi exercise is still inadequate .
BACKGROUND	Considering the difficulties for stroke patients to complete the whole exercise , the current trial evaluates the benefit of Tai Chi Yunshou exercise for patients with balance dysfunction after stroke through a cluster randomization , parallel-controlled design .
METHODS	A single-blind , cluster-randomized , parallel-controlled trial will be conducted .
METHODS	A total of 10 community health centers ( 5 per arm ) will be selected and randomly allocated into Tai Chi Yunshou exercise group or balance rehabilitation training group .
METHODS	Each community health centers will be asked to enroll 25 eligible patients into the trial .
METHODS	60minutes per each session , 1 session per day , 5 times per week and the total training round is 12weeks .
METHODS	Primary and secondary outcomes will be measured at baseline and 4-weeks , 8-weeks , 12-weeks , 6-week follow-up , 12-week follow-up after randomization .
METHODS	Safety and economic evaluation will also be assessed .
CONCLUSIONS	This protocol aims to evaluate the effectiveness of Tai Chi Yunshou exercise for the balance function of patients after stroke .
CONCLUSIONS	If the outcome is positive , this project will provide an appropriate and economic balance rehabilitation technology for community-based stroke patients .
BACKGROUND	Chinese Clinical Trial Registry : ChiCTR-TRC-13003641 .
BACKGROUND	Registration date : 22 August , 2013 http://www.chictr.org/usercenter/project/listbycreater.aspx .

###24621566
BACKGROUND	Smoking and metabolic syndrome ( MetS ) are major public health problems in modern society and are important risk factors of cardiovascular disease ( CVD ) .
BACKGROUND	The association of smoking , MetS , and CVD is widely reported , but reports targeted to women are few .
BACKGROUND	In the present study , we evaluated risk factors , including visceral fat area ( VFA ) , for CVD and development of subclinical atherosclerosis in female smokers especially .
RESULTS	Subjects consisted of 162 apparent healthy female and male smokers , and 315 age-matched never-smokers who underwent a health examination in the Osaka University Health Care Center .
RESULTS	For female smokers , lifestyle and carotid intima-media thickness ( IMT ) were evaluated .
RESULTS	Triglycerides were significantly higher and high-density lipoprotein-cholesterol significantly lower in smokers than in never-smokers for both men and women .
RESULTS	However , VFA was significantly high only in smoking women when compared with never-smokers .
RESULTS	Multivariate analysis revealed that age , body mass index , and smoking were the independent predictors of high VFA in women .
RESULTS	In addition , annual IMT increase was significantly higher in smokers than never-smokers in women .
CONCLUSIONS	VFA was notably high in female smokers , but the difference was not observed in men .
CONCLUSIONS	Smoking habit is an important risk factor of visceral fat accumulation and progression of subclinical atherosclerosis in women .

###25435806
BACKGROUND	Many tools have been developed to facilitate the insertion of the ProSeal laryngeal mask airway ( LMA ) insertion , which can be impeded by folding of its soft cuff .
BACKGROUND	The aim of this study was to compare the efficiency of ProSeal LMA insertion guided by a soft , direct optical Foley Airway Stylet Tool ( FAST ) with the standard introducer tool ( IT ) .
METHODS	One hundred sixty patients undergoing general anesthesia using the ProSeal LMA as an airway management device were randomly allocated to either FAST-guided or IT-assisted groups .
METHODS	Following ProSeal LMA insertion , the glottic and esophageal openings were identified using a fiberoptic bronchoscope introduced through the airway and the drain tube .
METHODS	The primary outcomes were time taken to insert the ProSeal LMA and the success rate at the first attempt .
METHODS	Secondary end points included ease of insertion , hemodynamic response to insertion , and postoperative adverse events recorded in the recovery room and on the first postoperative morning .
RESULTS	One hundred forty patients were included in the final analysis : 66 in the FAST-guided group and 74 in the IT-assisted group .
RESULTS	The success rate of FAST device-guided ProSeal LMA insertion ( 95.7 % ) was broadly comparable with IT-assisted insertion ( 98.7 % ) .
RESULTS	However , the time taken to insert the ProSeal LMA was significantly longer when the FAST technique was used ( p < 0.001 ) .
RESULTS	The incidence of correct alignment of the airway tube and the drain tube did not differ significantly between the groups .
RESULTS	There were no significant differences in ease of insertion or hemodynamic responses to insertion , except that the incidence of postoperative sore throat was significantly higher in the FAST group on the first postoperative day ( 22.2 % compared with 6.8 % in the IT group ; p = 0.035 ) .
CONCLUSIONS	Both FAST-guided and IT-assisted techniques achieved correct ProSeal LMA positioning , but the IT technique was significantly quicker and less likely to cause a sore throat .
BACKGROUND	ClinicalTrials.gov Identifier : NCT02048657 .

###25063959
BACKGROUND	The best available treatment for seasonal affective disorder ( SAD ) is light therapy .
BACKGROUND	Yet , this treatment does not prevent recurrence of depression in subsequent seasons .
BACKGROUND	The aim of the study is to gain preliminary insight in the efficacy of Mindfulness Based Cognitive Therapy ( MBCT ) in the prevention of SAD recurrence .
METHODS	This is a randomized controlled pilot study , in which SAD patients in remission were randomly allocated to an individual format of MBCT or a control condition ( i.e. treatment as usual ) .
METHODS	MBCT was given between May and June 2011 , when there was no presence of depressive symptoms .
METHODS	The Inventory for Depressive Symptomatology Self-Report ( IDS-SR ) , which patients received on a weekly basis from September 2011 to April 2012 , was used to assess moment of recurrence ( 20 ) and severity at moment of recurrence .
RESULTS	23 SAD patients were randomized to MBCT and 23 to the control condition .
RESULTS	Kaplan-Meier survival curve showed that the groups did not differ in moment of recurrence ( ( 1 ) .41 , p = .52 ) .
RESULTS	T-tests showed no group difference in mean IDS-SR scores at moment of recurrence ( t ( 31 ) = -.52 , p = .61 ) .
CONCLUSIONS	The results are limited by small sample size ( n = 46 ) and missing data of weekly IDS-SR assessments .
CONCLUSIONS	The findings of this pilot RCT suggest that individual MBCT is not effective in preventing a SAD recurrence when offered in a symptom free period ( i.e. spring ) .

###25678325
OBJECTIVE	To determine the effectiveness of an individually targeted Internet-based intervention with monetary incentives ( INCENT ) at reducing weight of overweight and obese employees when compared with a less-intensive intervention ( Livin ' My Weigh [ LMW ] ) 6 months after program initiation .
METHODS	Twenty-eight worksites were randomly assigned to either INCENT or LMW conditions .
METHODS	Both programs used evidence-based strategies to support weight loss .
METHODS	INCENT was delivered via daily e-mails over 12 months while LMW was delivered quarterly via both newsletters and on-site educational sessions .
METHODS	Generalized linear mixed models were conducted for weight change from baseline to 6 months post-program and using an intention-to-treat analysis to include all participants with baseline weight measurements .
RESULTS	Across 28 worksites , 1,790 employees ( M = 47 years of age ; 79 % Caucasian ; 74 % women ) participated .
RESULTS	Participants lost an average of 2.27 lbs ( P < 0.001 ) with a BMI decrease of 0.36 kg/m ( 2 ) ( P < 0.001 ) and 1.30 lbs ( P < 0.01 ) with a BMI decrease of 0.20 kg/m ( 2 ) ( P < 0.01 ) in INCENT and LMW , respectively .
RESULTS	The differences between INCENT and LMW in weight loss and BMI reduction were not statistically significant .
CONCLUSIONS	This study suggests that INCENT and a minimal intervention alternative may be effective approaches to help decrease the overall obesity burden within worksites .

###25891010
OBJECTIVE	To evaluate the efficacy and safety of etanercept in patients with enthesitis-related arthritis ( ERA ) in juvenile idiopathic arthritis ( JIA ) .
METHODS	This was a 2-phase study in JIA patients with active , refractory ERA .
METHODS	Phase I was an open-label , uncontrolled 24-week study period in which all patients were administered etanercept .
METHODS	Patients considered to be treatment responders at week 24 according to the American College of Rheumatology ( ACR ) Pediatric 30 ( Pedi 30 ) criteria for improvement in juvenile arthritis entered the second phase , a 24-week randomized , double-blind , placebo-controlled withdrawal study , for an additional 24 weeks , for evaluation of the primary end point , occurrence of a disease flare from week 24 to week 48 , based on the ACR preliminary definition of disease flare in juvenile arthritis .
RESULTS	Forty-one patients were enrolled .
RESULTS	At week 24 , treatment with etanercept resulted in response rates of 93 % , 93 % , 80 % , 56 % , and 54 % based on the ACR Pedi 30 , Pedi 50 , Pedi 70 , Pedi 90 , and Pedi 100 criteria , respectively .
RESULTS	In addition , a marked decrease in all disease activity measures was observed .
RESULTS	The mean number of tender joints , swollen joints , and joints with active arthritis decreased by 91 % , 97 % , and 94 % , respectively .
RESULTS	Physician 's global assessment of disease activity , parent 's assessment of patient 's overall well-being , and the Childhood Health Assessment Questionnaire disability index improved by 91 % , 80 % , and 86 % , respectively .
RESULTS	The number of tender enthesis sites and total scores for back pain , nocturnal pain , Bath Ankylosing Spondylitis Disease Activity Index , Bath Ankylosing Spondylitis Functional Index , and Juvenile Arthritis Disease Activity Score based on 10-joint counts ( JADAS10 ) decreased by 75 % , 72 % , 81 % , 72 % , 85 % , and 87 % , respectively .
RESULTS	In phase II , 38 patients were randomly assigned to receive placebo ( n = 18 ) or to continue receiving etanercept ( n = 20 ) .
RESULTS	Up to week 48 , 12 disease flares occurred , in 9 patients receiving placebo and 3 patients receiving etanercept ( odds ratio 6.0 , P = 0.02 ) .
RESULTS	There were no serious infections , malignancies , or deaths .
CONCLUSIONS	In this study of patients with the ERA category of JIA , etanercept proved effective , as indicated by high ACR Pedi response rates and JADAS10 response rates at week 24 .
CONCLUSIONS	Patients who continued treatment with etanercept had significantly fewer flares than those who received placebo , although 50 % of patients in the placebo group did not experience a flare .
CONCLUSIONS	Treatment suspension may be a consideration for patients with the ERA category of JIA who achieve remission .

###25096822
OBJECTIVE	Lactase non-persistence ( LNP ) , or primary hypolactasia , is a genetic condition that mediates lactose malabsorption and can cause lactose intolerance .
OBJECTIVE	Here we report the prevalence of lactose intolerance in a double-blind placebo study .
METHODS	The LCT C > T-13910 variant was genotyped by RT-PCR in 121 volunteers and lactose malabsorption was assessed using the hydrogen breath test ( HBT ) after consuming 25 g of lactose .
METHODS	Lactose intolerance was assessed by scoring symptoms ( SS ) using a standardized questionnaire following challenge with a lactose solution or saccharose placebo .
RESULTS	The LNP genotype was observed in 57 % of the volunteers , among whom 87 % were HBT .
RESULTS	In the HBT group the median SS was 9 and in the HBT group the median SS was 3 ( p < 0.001 ) .
RESULTS	No difference was observed in the SS when both groups were challenged with the placebo .
RESULTS	The most common symptoms included audible bowel sounds , abdominal pain and meteorism .
RESULTS	In the ROC curve analysis , an SS 6 demonstrated 72 % sensitivity and 81 % specificity for predicting a positive HBT .
RESULTS	To estimate prevalence , lactose intolerance was defined as the presence of an SS 6 points after subtracting the placebo effect and 34 % of the study population met this definition .
CONCLUSIONS	The LNP genotype was present in more than half of subjects evaluated and the observed prevalence of lactose intolerance was 34 % .

###25922190
OBJECTIVE	We performed a randomised trial in very preterm , small for gestational age ( SGA ) babies to determine if prophylaxis with granulocyte macrophage colony stimulating factor ( GM-CSF ) improves outcomes ( the PROGRAMS trial ) .
OBJECTIVE	GM-CSF was associated with improved neonatal neutrophil counts , but no change in other neonatal or 2-year outcomes .
OBJECTIVE	As subtle benefits in outcome may not be ascertainable until school age we performed an outcome study at 5years .
METHODS	280 babies born at 31weeks of gestation or less and SGA were entered into the trial .
METHODS	Outcomes were assessed at 5years to determine neurodevelopmental and general health status and educational attainment .
RESULTS	We found no significant differences in cognitive , general health or educational outcomes between 83 of 106 ( 78 % ) surviving children in the GM-CSF arm compared with 81 of 110 ( 74 % ) in the control arm .
RESULTS	Mean mental processing composite ( equivalent to IQ ) at 5years were 94 ( SD 16 ) compared with 95 ( SD 15 ) , respectively ( difference in means -1 ( 95 % CI -6 to 4 ) , and similar proportions were in receipt of special educational needs support ( 41 % vs 35 % ; risk ratio 1.2 ( 95 % CI 0.8 to 1.9 ) ) .
RESULTS	Performance on Kaufmann-ABC subscales and components of NEPSY were similar .
RESULTS	The suggestion of worse respiratory outcomes in the GM-CSF group at 2years was replicated at 5years .
CONCLUSIONS	The administration of GM-CSF to very preterm SGA babies is not associated with improved or more adverse neurodevelopmental , general health or educational outcomes at 5years .
BACKGROUND	ISRCTN42553489 .

###25073797
BACKGROUND	Today 's children are more overweight than previous generations and physical inactivity is a contributing factor .
BACKGROUND	Modelling and promoting positive behaviour in the early years is imperative for the development of lifelong health habits .
BACKGROUND	The social and physical environments where children spend their time have a powerful influence on behaviour .
BACKGROUND	Since the majority of preschool children spend time in care outside of the home , this provides an ideal setting to examine the ability of an intervention to enhance movement skills and modify physical activity behaviour .
BACKGROUND	This study aims to evaluate the efficacy of the Activity Begins in Childhood ( ABC ) intervention delivered in licensed daycare settings alone or in combination with a parent-driven home physical activity-promotion component to increase preschoolers ' overall physical activity levels and , specifically , the time spent in moderate to vigorous physical activity .
METHODS	This study is a single site , three-arm , cluster-randomized controlled trial design with a daycare centre as the unit of measurement ( clusters ) .
METHODS	All daycare centres in the National Capital region that serve children between the ages of 3 and 5 , expressing an interest in receiving the ABC intervention will be invited to participate .
METHODS	Those who agree will be randomly assigned to one of three groups : i ) ABC program delivered at a daycare centre only , ii ) ABC program delivered at daycare with a home/parental education component , or iii ) regular daycare curriculum .
METHODS	This study will recruit 18 daycare centres , 6 in each of the three groups .
METHODS	The intervention will last approximately 6months , with baseline assessment prior to ABC implementation and follow-up assessments at 3 and 6months .
CONCLUSIONS	Physical activity is an acknowledged component of a healthy lifestyle and childhood experiences as it has an important impact on lifelong behaviour and health .
CONCLUSIONS	Opportunities for physical activity and motor development in early childhood may , over the lifespan , influence the maintenance of a healthy body weight and reduce cardiovascular disease risk .
CONCLUSIONS	If successful , the ABC program may be implemented in daycare centres as an effective way of increasing healthy activity behaviours of preschoolers .
BACKGROUND	Current Controlled Trials : ISRCTN94022291 .
BACKGROUND	Registered in December 2012 , first cluster randomized in April 2013 .

###25327602
OBJECTIVE	To observe the impact of plant sterol esters ( PSE ) mixed in low fat milk powder ( 2.5 g of PSE/day ) on plasma cholesterol levels in hypercholesterolemic subjects during a 6-week intervention period .
METHODS	In this double-blind , randomized , placebo-controlled study , 59 subjects ( 19 males , mean age ( 60.28 6.98 ) years ) with primary hypercholesterolemia ( fasting LDL cholesterol between 3.4-6 .0 mmol/L ) were randomly divided into two groups ( treatment group , 2.5 g of plant sterol esters a day , n = 30 ) and placebo group ( n = 29 ) .
METHODS	Blood samples were collected at week 0 , 3 and 6 .
METHODS	The primary outcome was change in plasma LDL-cholesterol ( LDL-C ) .
METHODS	Secondary outcomes were changes in total cholesterol ( TC ) , HDL cholesterol ( HDL-C ) , triglycerides ( TG ) , anthropometry and blood biochemistry .
RESULTS	LDL-C significantly reduction from baseline ( 4.18 0.54 ) mmol/L to ( 3.44 0.61 ) mmol/L ( -17.7 % , P < 0.05 ) at week 3 and ( 3.35 0.39 ) mmol/L ( -19.9 % , P < 0.05 ) at week 6 in the treatment group , whereas in placebo group from ( 4.11 0.54 ) mmol/L at baseline to ( 3.47 0.60 ) mmol/L ( -15.57 % , P < 0.05 ) and ( 3.61 0.39 ) mmol/L ( -12.17 % , P < 0.05 ) at week 3 and week 6 , respectively .
RESULTS	TC was reduced from ( 6.30 0.86 ) mmol/L at baseline to ( 5.92 0.75 ) mmol/L ( -6.03 % , P > 0.05 ) at week 3 and ( 5.43 0.77 ) mmol/L ( -13.8 % , P < 0.05 ) at week 6 in treatment group , from ( 6.20 0.76 ) mmol/L at week 0 to ( 5.70 0.76 ) mmol/L ( -8.06 % , P < 0.05 ) at week 3 and ( 5.84 0.75 ) mmol/L ( -5.81 % , P < 0.05 ) at week 6 in placebo group .
RESULTS	PSE-enriched milk did not affect plasma HDL-C level and TG level at both week 3 and week 6 .
RESULTS	After normalization to the placebo group , the treatment group showed significant reduction in LDL-C and total cholesteron after 6 weeks .
RESULTS	The observed difference of reduction was 7.69 % ( -0.33 mmol/L , P < 0.05 ) for LDL-C and 8.00 % ( -0.51 mmol/L , P < 0.05 ) for TC between the two groups .
RESULTS	There were no significant changes in safety parameters , including blood biochemistry tests during the study period .
CONCLUSIONS	Plant sterol ester enriched milk powder is effective in reducing LDL-C among Chinese hypercholesterolemic subjects at a dosage recommended by EFSA .

###24998258
BACKGROUND	One of the most dreaded complications of septic shock is acute kidney injury .
BACKGROUND	It occurs in around 50 % of patients , with a mortality rate of about 60 % at 3 months .
BACKGROUND	There is no consensus on the optimal time to initiate renal replacement therapy .
BACKGROUND	Retrospective and observational studies suggest that early implementation of renal replacement therapy could improve the prognosis for these patients .
METHODS	This protocol summarizes the rationale and design of a randomized , controlled , multicenter trial investigating the effect of early versus delayed renal replacement therapy in patients with severe acute kidney injury in early septic shock .
METHODS	In total , 864 critically ill adults with septic shock and evidence of acute kidney injury , defined as the failure stage of the RIFLE classification , will be enrolled .
METHODS	The primary outcome is mortality at 90 days .
METHODS	Secondary outcomes include safety , number of days free of mechanical ventilation , number of days free of renal replacement therapy , intensive care length of stay , in-hospital length of stay , quality of life as evaluated by the EQ-5D and renal replacement therapy dependence at hospital discharge .
METHODS	The primary analysis will be intention to treat .
METHODS	Recruitment started in March 2012 and will be completed by March 2015 .
CONCLUSIONS	This protocol for a randomized controlled study investigating the impact of the timing of renal replacement therapy initiation should provide an answer to a key question for the management of patients with acute kidney injury in the context of septic shock , for whom the mortality rate remains close to 60 % despite improved understanding of physiopathology and recent therapeutic advances .
BACKGROUND	ClinicalTrials.gov identifier NCT01682590 , registered on 10 September 2012 .

###25140772
OBJECTIVE	To investigate the safety and efficacy of low-concentration inhaled nitric oxide ( NO ) in the treatment of hypoxic respiratory failure ( HRF ) among premature infants .
METHODS	Sixty premature infants ( gestational age 34 weeks ) with HRF were randomized into NO and control groups between 2012 and 2013 , with 30 cases in each group .
METHODS	Both groups received nasal continuous positive airway pressure ( nCPAP ) or mechanical ventilation .
METHODS	NO inhalation was continued for at least 7 days or until weaning in the NO group .
METHODS	The general conditions , blood gas results , complications , and clinical outcomes of the two groups were analyzed .
RESULTS	The NO group showed significantly more improvement in blood gas results than the control group after 12 hours of treatment ( P < 0.05 ) .
RESULTS	After that , the change in oxygenation status over time showed no significant difference between the two groups ( P > 0.05 ) .
RESULTS	There were no significant differences in total time of assisted ventilation and duration of oxygen therapy between the two groups ( P > 0.05 ) .
RESULTS	The incidence of bronchopulmonary dysplasia ( BPD ) , patent ductus arteriosus , necrotizing enterocolitis , retinopathy of prematurity , and pneumothorax in infants showed no significant differences between the NO and control groups ( P > 0.05 ) , but the incidence of IVH and mortality were significantly lower in the NO group than in the control group ( 7 % vs 17 % , P < 0.05 ; 3 % vs 13 % , P < 0.05 ) .
CONCLUSIONS	NO inhalation may improve oxygenation status and reduce the mortality in premature infants with HRF , but it can not reduce the incidence of BPD and the total time of mechanical ventilation or nCPAP and duration of oxygen therapy .
CONCLUSIONS	NO therapy may have a brain-protective effect for premature infants with HRF and does not increase clinical complications .

###25623102
OBJECTIVE	To explore the clinical efficacies of different internal fixation materials in the treatment of senile proximal humerus fractures .
METHODS	A total of 284 hospitalized patients of proximal humerus fractures over 60 years of age cases from October 2009 to February 2012 were randomly divided into two groups of locking proximal humeral plate ( LPHP ) and PHILOS ( n = 142 each ) .
METHODS	And the clinical efficacies of two groups were compared .
RESULTS	For PHILOS and LPHP groups , the fracture healing periods were ( 11.64 3.81 ) and ( 14.95 3.95 ) weeks .
RESULTS	And there was statistical significance ( P < 0.05 ) .
RESULTS	At 3 months post-surgery , the incidence of pain was 72.41 % and 64.81 % .
RESULTS	And there was statistical significance ( P < 0.05 ) .
RESULTS	At 2 years , Neer shoulder function score had inter-group statistically insignificant difference ( P > 0.05 ) .
CONCLUSIONS	Both PHILOS and LPHP are effective in the treatment of senile proximal humeral fractures.However , the former is conducive to fracture healing and has shorter healing time and lowered postoperative pain .

###24232364
OBJECTIVE	Few studies have addressed the rehabilitation of hand function in persons with severe impairment following stroke , and few therapeutic options are available for treatment .
OBJECTIVE	We investigated whether an intervention of robot-assisted movement and muscle vibration could reduce impairment and enable hand-opening to a greater extent when combined with torque biofeedback or electromyographic ( EMG ) biofeedback .
METHODS	Forty-three participants with severe hand impairment due to chronic stroke ( 1 year poststroke ) were randomized to 1 of 2 treatment groups receiving assisted movement and muscle vibration combined with either torque or EMG biofeedback .
METHODS	Each participant received 30 sessions ( 30 minutes duration per session ) directed at the impaired hand over 10 to 12 weeks .
METHODS	Outcomes were assessed using the Upper Extremity Fugl-Meyer Assessment ( UE-FMA ) , Stroke Impact Scale , and Box-and-Block Test scores .
RESULTS	Twenty-eight of 43 participants had no baseline finger extension ; the remainder had an average of 23 26 mm extension in the most active finger .
RESULTS	Assisted movement and muscle vibration were associated with a significant increase in all outcome measures across both treatment groups , and for the UE-FMA and Stroke Impact Scale within treatment groups , with no significant difference between groups .
RESULTS	Based on the Box-and-Block Test scores , the assisted movement and muscle vibration intervention did not restore functional hand-opening to participants with baseline UE-FMA scores less than 17/66 , regardless of the form of biofeedback .
CONCLUSIONS	Assisted movement and muscle vibration , combined with either EMG or torque biofeedback , appears to reduce upper limb impairment , improve volitional activation of the hand muscles , and restore a modicum of hand function in some persons with severe hand impairment due to chronic stroke.Video Abstract available ( see Video , Supplemental Digital Content 1 , http://links.lww.com/JNPT/A64 ) for more insights from the authors .

###24623024
OBJECTIVE	The optimal perioperative blood glucose range to improve surgical site infection ( SSI ) in surgical intensive care unit ( ICU ) patients remains unclear .
OBJECTIVE	We sought to determine whether the incidence of SSI is reduced by perioperative intensive insulin therapy ( IT ) .
METHODS	Patients were randomly assigned to receive perioperative intensive IT , with a target blood glucose range of 4.4-6 .1 mmol/L , or intermediate IT , with a target blood glucose range of 7.7-10 .0 mmol/L in the surgical ICU .
METHODS	We defined the primary end point as the incidence of SSI .
RESULTS	Study participants were randomly assigned to glucose control with one of two target ranges : for 225 patients in the intermediate IT group or for 222 patients in the intensive IT group , respectively .
RESULTS	No patients in either group became hypoglycemic ( < 4.4 mmol/L ) during their stay in the surgical ICU .
RESULTS	In our series , the rate of SSI after hepato-biliary-pancreatic surgery was 6.7 % .
RESULTS	Patients in the intensive IT group , compared with the intermediate IT group , had fewer postoperative SSIs ( 9.8 % vs. 4.1 % , P = 0.028 ) and a lower incidence of postoperative pancreatic fistula after pancreatic resection ( P = 0.040 ) .
RESULTS	The length of hospitalization required for patients in the intensive IT group was significantly shorter than that in the intermediate IT group ( P = 0.017 ) .
CONCLUSIONS	We found that intensive IT decreased the incidence of SSI among patients who underwent hepato-biliary-pancreatic surgery : a blood glucose target of 4.4 to 6.1 mmol/L resulted in lower rate of SSI than did a target of 7.7-10 .0 mmol/L .

###24229408
BACKGROUND	Phylogenetic comparative analyses usually rely on a single consensus phylogenetic tree in order to study evolutionary processes .
BACKGROUND	However , most phylogenetic trees are incomplete with regard to species sampling , which may critically compromise analyses .
BACKGROUND	Some approaches have been proposed to integrate non-molecular phylogenetic information into incomplete molecular phylogenies .
BACKGROUND	An expanded tree approach consists of adding missing species to random locations within their clade .
BACKGROUND	The information contained in the topology of the resulting expanded trees can be captured by the pairwise phylogenetic distance between species and stored in a matrix for further statistical analysis .
BACKGROUND	Thus , the random expansion and processing of multiple phylogenetic trees can be used to estimate the phylogenetic uncertainty through a simulation procedure .
BACKGROUND	Because of the computational burden required , unless this procedure is efficiently implemented , the analyses are of limited applicability .
RESULTS	In this paper , we present efficient algorithms and implementations for randomly expanding and processing phylogenetic trees so that simulations involved in comparative phylogenetic analysis with uncertainty can be conducted in a reasonable time .
RESULTS	We propose algorithms for both randomly expanding trees and calculating distance matrices .
RESULTS	We made available the source code , which was written in the C++ language .
RESULTS	The code may be used as a standalone program or as a shared object in the R system .
RESULTS	The software can also be used as a web service through the link : http://purl.oclc.org/NET/sunplin/ .
CONCLUSIONS	We compare our implementations to similar solutions and show that significant performance gains can be obtained .
CONCLUSIONS	Our results open up the possibility of accounting for phylogenetic uncertainty in evolutionary and ecological analyses of large datasets .

###26283758
OBJECTIVE	We compared the effect of clopidogrel plus aspirin vs aspirin alone on functional outcome and quality of life in the Clopidogrel in High-risk Patients with Acute Non-disabling Cerebrovascular Events ( CHANCE ) trial of aspirin-clopidogrel vs aspirin alone after acute minor stroke or TIA .
METHODS	Participants were assessed at 90 days for functional outcome using the modified Rankin Scale ( mRS ) and quality of life using the EuroQol-5 Dimension ( EQ-5D ) .
METHODS	Poor functional outcome was defined as mRS score of 2-6 at 90 days and poor quality of life as EQ-5D index score of 0.5 or less .
RESULTS	Poor functional outcome occurred in 254 patients ( 9.9 % ) in the clopidogrel-aspirin group , as compared with 299 ( 11.6 % ) in the aspirin group ( p = 0.046 ) .
RESULTS	Poor quality of life occurred in 142 ( 5.5 % ) in the clopidogrel-aspirin group and in 175 ( 6.8 % ) in the aspirin group ( p = 0.06 ) .
RESULTS	Disabling stroke at 90 days occurred in 166 ( 6.5 % ) in the clopidogrel-aspirin group and in 219 ( 8.5 % ) in the aspirin group ( p = 0.01 ) .
RESULTS	In stratified analysis by subsequent stroke , there was no difference in 90-day functional outcome and quality of life between the 2 groups .
CONCLUSIONS	In patients with minor stroke or TIA , the combination of clopidogrel and aspirin appears to be superior to aspirin alone in improving the 90-day functional outcome , and this is consistent with a reduction in the rate of disabling stroke in the dual antiplatelet arm .
METHODS	This study provides Class II evidence that for patients with acute minor stroke or TIA , clopidogrel plus aspirin compared to aspirin alone improves 90-day functional outcome ( absolute reduction of poor outcome 1.70 % , 95 % confidence interval 0.03 % -3.42 % ) .

###25644442
OBJECTIVE	Treatment for advanced-stage epithelial ovarian cancer ( AEOC ) includes primary debulking surgery ( PDS ) or neoadjuvant chemotherapy ( NACT ) .
OBJECTIVE	A randomized controlled trial comparing these treatments resulted in comparable overall survival ( OS ) .
OBJECTIVE	Studies report more complications and lower chemotherapy completion rates in patients 65 years old or older receiving PDS .
OBJECTIVE	We sought to evaluate the cost implications of NACT relative to PDS in AEOC patients 65 years old or older .
METHODS	A 5 year Markov model was created .
METHODS	Arm 1 modeled PDS followed by 6 cycles of carboplatin and paclitaxel ( CT ) .
METHODS	Arm 2 modeled 3 cycles of CT , followed by interval debulking surgery and then 3 additional cycles of CT. .
METHODS	Parameters included OS , surgical complications , probability of treatment initiation , treatment cost , and quality of life ( QOL ) .
METHODS	OS was assumed to be equal based on the findings of the international randomized control trial .
METHODS	Differences in surgical complexity were accounted for in base surgical cost plus add-on procedure costs weighted by occurrence rates .
METHODS	Hospital cost was a weighted average of diagnosis-related group costs weighted by composite estimates of complication rates .
METHODS	Sensitivity analyses were performed .
RESULTS	Assuming equal survival , NACT produces a cost savings of $ 5616 .
RESULTS	If PDS improved median OS by 1.5 months or longer , PDS would be cost effective ( CE ) at a $ 100,000 / quality-adjusted life-year threshold .
RESULTS	If PDS improved OS by 3.2 months or longer , it would be CE at a $ 50,000 threshold .
RESULTS	The model was robust to variation in costs and complication rates .
RESULTS	Moderate decreases in the QOL with NACT would result in PDS being CE .
CONCLUSIONS	A model based on the RCT comparing NACT and PDS showed NACT is a cost-saving treatment compared with PDS for AEOC in patients 65 years old or older .
CONCLUSIONS	Small increases in OS with PDS or moderate declines in QOL with NACT would result in PDS being CE at the $ 100,000 / quality-adjusted life-year threshold .
CONCLUSIONS	Our results support further evaluation of the effects of PDS on OS , QOL and complications in AEOC patients 65 years old or older .

###24330784
BACKGROUND	Aortic dissection is a lift-threatening medical emergency associated with high rates of morbidity and mortality .
BACKGROUND	The incidence rate of aortic dissection is estimated at 5 to 30 per 1 million people per year .
BACKGROUND	The prompt and correct diagnosis of aortic dissection is critical .
BACKGROUND	This study was to compare the ascending aortic image quality and the whole aortic radiation dose of high-pitch dual-source CT angiography and conventional dual-source CT angiography .
METHODS	A total of 110 consecutive patients with suspected aortic dissection and other aortic disorders were randomly divided into two groups .
METHODS	Group A underwent traditional scan mode and Group B underwent high-pitch dual-source CT scan mode .
METHODS	The image quality and radiation dose of two groups were compared .
RESULTS	Close interobserver agreement was found for image quality scores ( = 0.87 ) .
RESULTS	The image quality of ascending aorta was significantly better in the high-pitch group than in the conventional group ( 2.78 0.46 vs 1.57 0.43 , P < 0.001 ) .
RESULTS	There was no significant difference of the CT attenuation values , the aortic image noise and SNR between two groups .
RESULTS	The mean radiation dose of high-pitch group was also significantly lower than that of conventional group ( 2.7 0.6 mSv vs. 3.9 0.9 mSv , P < 0.001 ) .
CONCLUSIONS	High-pitch dual-source CT angiography of the whole aorta can provide motion-artifact-free imaging of the ascending aorta at a low radiation dose compared to conventional protocol .

###25746563
OBJECTIVE	To evaluate ictal adipokine levels in episodic migraineurs and their association with pain severity and treatment response .
METHODS	This was a double-blind , placebo-controlled trial evaluating peripheral blood specimens from episodic migraineurs at acute pain onset and 30 to 120 minutes after treatment with sumatriptan/naproxen sodium vs placebo .
METHODS	Total adiponectin ( T-ADP ) , ADP multimers ( high molecular weight [ HMW ] , middle molecular weight , and low molecular weight [ LMW ] ) , leptin , and resistin levels were evaluated by immunoassays .
RESULTS	Thirty-four participants ( 17 responders , 17 nonresponders ) were included .
RESULTS	In all participants , pretreatment pain severity increased with every quartile increase in both the HMW : T-ADP ratio ( coefficient of variation [ CV ] 0.51 ; 95 % confidence interval [ CI ] : 0.08 , 0.93 ; p = 0.019 ) and resistin levels ( CV 0.58 ; 95 % CI : 0.21 , 0.96 ; p = 0.002 ) , but was not associated with quartile changes in leptin levels .
RESULTS	In responders , T-ADP ( CV -0.98 ; 95 % CI : -1.88 , -0.08 ; p = 0.031 ) and resistin ( CV -0.95 ; 95 % CI : -1.83 , -0.07 ; p = 0.034 ) levels decreased 120 minutes after treatment as compared with pretreatment .
RESULTS	In addition , in responders , the HMW : T-ADP ratio ( CV -0.04 ; 95 % CI : -0.07 , -0.01 ; p = 0.041 ) decreased and the LMW : T-ADP ratio ( CV 0.04 ; 95 % CI : 0.01 , 0.07 ; p = 0.043 ) increased at 120 minutes after treatment .
RESULTS	In nonresponders , the LMW : T-ADP ratio ( CV -0.04 ; 95 % CI : -0.07 , -0.01 ; p = 0.018 ) decreased 120 minutes after treatment .
RESULTS	Leptin was not associated with treatment response .
CONCLUSIONS	Both pretreatment migraine pain severity and treatment response are associated with changes in adipokine levels .
CONCLUSIONS	Adipokines represent potential novel migraine biomarkers and drug targets .

###25136077
BACKGROUND	The benefit of novel implantable cardioverter defibrillator ( ICD ) programming in reducing inappropriate ICD therapy and mortality was demonstrated in Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy ( MADIT-RIT ) .
BACKGROUND	However , the cause of mortality reduction remains incompletely evaluated .
BACKGROUND	We aimed to identify factors associated with mortality , with focus on ICD therapy and programming in the MADIT-RIT population .
RESULTS	In MADIT-RIT , 1500 patients with a primary prophylactic indication for ICD or cardiac resynchronization therapy with defibrillator were randomized to 1 of 3 different ICD programming arms : conventional programming ( ventricular tachycardia zone 170 beats per minute ) , high-rate programming ( ventricular tachycardia zone 200 beats per minute ) , and delayed programming ( 60-second delay before therapy 170 beats per minute ) .
RESULTS	Multivariate Cox models were used to assess the influence of time-dependent appropriate and inappropriate ICD therapy ( shock and antitachycardia pacing ) and randomized programming arm on all-cause mortality .
RESULTS	During an average follow-up of 1.40.6 years , 71 of 1500 ( 5 % ) patients died : cardiac in 40 patients ( 56.3 % ) , noncardiac in 23 patients ( 32.4 % ) , and unknown in 8 patients ( 11.3 % ) .
RESULTS	Appropriate shocks ( hazard ratio , 6.32 ; 95 % confidence interval , 3.13-12 .75 ; P < 0.001 ) and inappropriate therapy ( hazard ratio , 2.61 ; 95 % confidence interval , 1.28-5 .31 ; P = 0.01 ) were significantly associated with an increased mortality risk .
RESULTS	There was no evidence of increased mortality risk in patients who experienced appropriate antitachycardia pacing only ( hazard ratio , 1.02 ; 95 % confidence interval , 0.36-2 .88 ; P = 0.98 ) .
RESULTS	Randomization to conventional programming was identified as an independent predictor of death when compared with patients randomized to high-rate programming ( hazard ratio , 2.0 ; 95 % confidence interval , 1.06-3 .71 ; P = 0.03 ) .
CONCLUSIONS	In MADIT-RIT , appropriate shocks , inappropriate ICD therapy , and randomization to conventional ICD programming were independently associated with an increased mortality risk .
CONCLUSIONS	Appropriate antitachycardia pacing was not related to an adverse outcome .
BACKGROUND	clinicaltrials.gov Unique identifier : NCT00947310 .

###25793429
BACKGROUND	Depression is common in patients with chronic kidney disease who are on hemodialysis .
BACKGROUND	Available behavioral modalities for treating depression may not be feasible for patients who receive hemodialysis two or three times per week .
OBJECTIVE	The purpose of this randomized controlled trial was to examine the efficacy of a nurse-led , in-center breathing training program in reducing depressive symptoms and improving sleep quality and health-related quality of life in patients on maintenance hemodialysis .
METHODS	Fifty-seven patients on hemodialysis were randomly assigned either to an eight-session breathing training group or to a control group .
METHODS	The Beck Depression Inventory II ( BDI-II ) , the Pittsburgh Sleep Quality Index ( PSQI ) , and the Medical Outcome Studies 36-Item Short Form Health Survey ( SF-36 ) were used to assess self-reported depressive symptoms , sleep quality , and health-related quality of life , respectively .
RESULTS	The intervention group exhibited significantly greater decreases in BDI-II scores than the control group .
RESULTS	No significant differences in PSQI change scores were observed between the groups .
RESULTS	SF-36 change scores for both the domain of role limitation due to emotional problems and the mental component summary were significantly higher in the breathing training group than in the control group .
CONCLUSIONS	This intervention significantly alleviated depressive symptoms , reduced perceived role limitation due to emotional problems , and improved the overall mental health component of quality of life in patients on maintenance hemodialysis .

###25842221
BACKGROUND	WHO recommends hospital-based treatment for young infants aged 0-59 days with clinical signs of possible serious bacterial infection , but most families in resource-poor settings can not accept referral .
BACKGROUND	We aimed to assess whether use of simplified antibiotic regimens to treat young infants with clinical signs of severe infection was as efficacious as an injectable procaine benzylpenicillin-gentamicin combination for 7 days for situations in which hospital referral was not possible .
METHODS	In a multisite open-label equivalence trial in DR Congo , Kenya , and Nigeria , community health workers visited all newborn babies at home , identifying and referring unwell young infants to a study nurse .
METHODS	We stratified young infants with clinical signs of severe infection whose parents did not accept referral to hospital by age ( 0-6 days and 7-59 days ) , and randomly assigned each individual within these strata to receive one of the four treatment regimens .
METHODS	Randomisation was stratified by age group of infants .
METHODS	An age-stratified randomisation scheme with block size of eight was computer-generated off-site at WHO .
METHODS	The outcome assessor was masked .
METHODS	We randomly allocated infants to receive injectable procaine benzylpenicillin-gentamicin for 7 days ( group A , reference group ) ; injectable gentamicin and oral amoxicillin for 7 days ( group B ) ; injectable procaine benzylpenicillin-gentamicin for 2 days , then oral amoxicillin for 5 days ( group C ) ; or injectable gentamicin for 2 days and oral amoxicillin for 7 days ( group D ) .
METHODS	Trained health professionals gave daily injections and the first dose of oral amoxicillin .
METHODS	Our primary outcome was treatment failure by day 8 after enrolment , defined as clinical deterioration , development of a serious adverse event ( including death ) , no improvement by day 4 , or not cured by day 8 .
METHODS	Independent outcome assessors , who did not know the infant 's treatment regimen , assessed study outcomes on days 4 , 8 , 11 , and 15 .
METHODS	Primary analysis was per protocol .
METHODS	We used a prespecified similarity margin of 5 % to assess equivalence between regimens .
METHODS	This study is registered with the Australian New Zealand Clinical Trials Registry , number ACTRN12610000286044 .
RESULTS	In Kenya and Nigeria , we started enrolment on April 4 , 2011 , and we enrolled the necessary number of young infants aged 7 days or older from Oct 17 , 2011 , to April 30 , 2012 .
RESULTS	At these sites , we continued to enrol infants younger than 7 days until March 29 , 2013 .
RESULTS	In DR Congo , we started enrolment on Sept 17 , 2012 , and continued until June 28 , 2013 .
RESULTS	We randomly assigned 3564 young infants to either group A ( n = 894 ) , group B ( n = 884 ) , group C ( n = 896 ) , or group D ( n = 890 ) .
RESULTS	We excluded 200 randomly assigned infants , who did not fulfil the predefined criteria of adherence to treatment and adequate follow-up .
RESULTS	In the per-protocol analysis , 828 infants were included in group A , 826 in group B , 862 in group C , and 848 in group D. 67 ( 8 % ) infants failed treatment in group A compared with 51 ( 6 % ) infants in group B ( risk difference -19 % , 95 % CI -44 to 01 ) , 65 ( 8 % ) in group C ( -06 % , -31 to 20 ) , and 46 ( 5 % ) in group D ( -27 % , -51 to 03 ) .
RESULTS	Treatment failure in groups B , C , and D was within the similarity margin compared with group A.
RESULTS	During the 15 days after random allocation , 12 ( 1 % ) infants died in group A , compared with ten ( 1 % ) infants in group B , 20 ( 2 % ) infants in group C , and 11 ( 1 % ) infants in group D.
RESULTS	An infant in group A had a serious adverse event other than death ( injection abscess ) .
CONCLUSIONS	The three simplified regimens were as effective as injectable procaine benzylpenicillin-gentamicin for 7 days on an outpatient basis in young infants with clinical signs of severe infection , without signs of critical illness , and whose caregivers did not accept referral for hospital admission .
BACKGROUND	Bill & Melinda Gates Foundation grant to WHO .

###25495490
BACKGROUND	Suppression of ovarian estrogen production reduces the recurrence of hormone-receptor-positive early breast cancer in premenopausal women , but its value when added to tamoxifen is uncertain .
METHODS	We randomly assigned 3066 premenopausal women , stratified according to prior receipt or nonreceipt of chemotherapy , to receive 5 years of tamoxifen , tamoxifen plus ovarian suppression , or exemestane plus ovarian suppression .
METHODS	The primary analysis tested the hypothesis that tamoxifen plus ovarian suppression would improve disease-free survival , as compared with tamoxifen alone .
METHODS	In the primary analysis , 46.7 % of the patients had not received chemotherapy previously , and 53.3 % had received chemotherapy and remained premenopausal .
RESULTS	After a median follow-up of 67 months , the estimated disease-free survival rate at 5 years was 86.6 % in the tamoxifen-ovarian suppression group and 84.7 % in the tamoxifen group ( hazard ratio for disease recurrence , second invasive cancer , or death , 0.83 ; 95 % confidence interval [ CI ] , 0.66 to 1.04 ; P = 0.10 ) .
RESULTS	Multivariable allowance for prognostic factors suggested a greater treatment effect with tamoxifen plus ovarian suppression than with tamoxifen alone ( hazard ratio , 0.78 ; 95 % CI , 0.62 to 0.98 ) .
RESULTS	Most recurrences occurred in patients who had received prior chemotherapy , among whom the rate of freedom from breast cancer at 5 years was 82.5 % in the tamoxifen-ovarian suppression group and 78.0 % in the tamoxifen group ( hazard ratio for recurrence , 0.78 ; 95 % CI , 0.60 to 1.02 ) .
RESULTS	At 5 years , the rate of freedom from breast cancer was 85.7 % in the exemestane-ovarian suppression group ( hazard ratio for recurrence vs. tamoxifen , 0.65 ; 95 % CI , 0.49 to 0.87 ) .
CONCLUSIONS	Adding ovarian suppression to tamoxifen did not provide a significant benefit in the overall study population .
CONCLUSIONS	However , for women who were at sufficient risk for recurrence to warrant adjuvant chemotherapy and who remained premenopausal , the addition of ovarian suppression improved disease outcomes .
CONCLUSIONS	Further improvement was seen with the use of exemestane plus ovarian suppression .
CONCLUSIONS	( Funded by Pfizer and others ; SOFT ClinicalTrials.gov number , NCT00066690 . )

###25255113
BACKGROUND	A previous randomized controlled trial showed no clear superiority of vertical scar over inverted T-shaped reduction mammaplasty in terms of health-related quality of life .
BACKGROUND	No economic evaluation has been undertaken comparing vertical scar reduction and inverted T - shaped reduction .
METHODS	A total of 255 patients were randomized to either vertical scar or inverted T - shaped reduction .
METHODS	The effectiveness was measured with the Health Utilities Index Mark 3 .
METHODS	Direct and productivity costs were captured parallel to the randomized controlled trial .
METHODS	Perspectives of the Ministry of Health , patient , and society were considered .
RESULTS	Inverted T - shaped reduction dominated vertical scar reduction from the Ministry of Health perspective by being slightly less costly ( $ 3090.06 versus $ 3106.58 ) and slightly more effective ( 0.87 quality-adjusted life-years versus 0.86 quality-adjusted life-years ) .
RESULTS	From the societal and patient perspectives , vertical scar reduction was both less costly and less effective .
RESULTS	At the commonly quoted Canadian threshold of $ 50,000 per quality-adjusted life-year gained , the probability that vertical scar reduction was cost-effective was 29.3 , 68.2 , and 66.9 percent from the Ministry of Health , patient , and societal perspectives .
RESULTS	Subgroup analysis of reductions less than 500 g found that vertical scar reduction was more likely cost-effective .
CONCLUSIONS	Vertical scar reduction is more likely than not cost-effective from patient and societal perspectives but not from the Ministry of Health perspective at a willingness-to-pay threshold of $ 50,000 per quality-adjusted life-year .
CONCLUSIONS	If we limit vertical scar reduction for resections less than 500 g per breast , this technique is more likely cost-effective from all perspectives .

###25762810
BACKGROUND	Resistance training ( RT ) improves muscle strength and overall physical function in older adults .
BACKGROUND	RT may be particularly important in the obese elderly who have compromised muscle function .
BACKGROUND	Whether caloric restriction ( CR ) acts synergistically with RT to enhance function is unknown .
OBJECTIVE	As the primary goal of the Improving Muscle for Functional Independence Trial ( I 'M FIT ) , we determined the effects of adding CR for weight loss on muscle and physical function responses to RT in older overweight and obese adults .
METHODS	I 'M FIT was a 5-mo trial in 126 older ( 65-79 y ) overweight and obese men and women who were randomly assigned to a progressive , 3-d/wk , moderate-intensity RT intervention with a weight-loss intervention ( RT+CR ) or without a weight-loss intervention ( RT ) .
METHODS	The primary outcome was maximal knee extensor strength ; secondary outcomes were muscle power and quality , overall physical function , and total body and thigh compositions .
RESULTS	Body mass decreased in the RT+CR group but not in the RT group .
RESULTS	Fat mass , percentage of fat , and all thigh fat volumes decreased in both groups , but only the RT+CR group lost lean mass .
RESULTS	Adjusted postintervention body - and thigh-composition measures were all lower with RT+CR except intermuscular adipose tissue ( IMAT ) .
RESULTS	Knee strength , power , and quality and the 4-m gait speed increased similarly in both groups .
RESULTS	Adjusted postintervention means for a 400-m walk time and self-reported disability were better with RT+CR with no group differences in other functional measures , including knee strength .
RESULTS	Participants with a lower percentage of fat and IMAT at baseline exhibited a greater improvement in the 400-m walk and knee strength and power .
CONCLUSIONS	RT improved body composition ( including reducing IMAT ) and muscle strength and physical function in obese elderly , but those with higher initial adiposity experienced less improvement .
CONCLUSIONS	The addition of CR during RT improves mobility and does not compromise other functional adaptations to RT. .
CONCLUSIONS	These findings support the incorporation of RT into obesity treatments for this population regardless of whether CR is part of the treatment .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01049698 .

###25032220
OBJECTIVE	To investigate the effect of two foot placements ( normal or posterior placement ) and three arm positions ( hands on the thighs , arms crossed over chest , and augmented arm position with elbow extended ) on the five times sit-to-stand ( FTSTS ) test times of individuals with chronic stroke .
METHODS	Cross-sectional study .
METHODS	Setting .
METHODS	University-based rehabilitation clinic .
METHODS	A convenience sample of community-dwelling individuals with chronic stroke ( N = 45 ) .
METHODS	The times in completing the FTSTS with two foot placements and the three arm positions were recorded by stopwatch .
RESULTS	Posterior foot placement led to significantly shorter FTSTS times when compared with normal foot placement in all the 3 arm positions ( P 0.001 ) .
RESULTS	In addition , hands on thigh position led to significantly longer FTSTS times than the augmented arm position ( P = 0.014 ) .
CONCLUSIONS	Our results showed that foot placement and arm position could influence the FTSTS times of individuals with chronic stroke .
CONCLUSIONS	Standardizing the foot placement and arm position in the test procedure is essential , if FTSTS test is intended to be used repeatedly on the same subject .

###24619151
BACKGROUND	It is unknown whether intentional weight loss provides long-term benefits for cognitive function .
METHODS	An ancillary study to a randomized controlled clinical trial was conducted in overweight and obese individuals ( N = 978 ) , aged 45-76 years at enrollment , with type 2 diabetes .
METHODS	An intensive behavioral intervention designed to promote and maintain weight loss through caloric restriction and increased physical activity was compared with diabetes support and education .
METHODS	Standardized assessments of cognitive function were collected an average of 8.1 years after trial enrollment .
RESULTS	Participants assigned to intensive lifestyle intervention lost a mean ( SE ) 11.1 % ( 0.4 % ) and 7.2 % ( 0.5 % ) of weight at Years 1 and 8 , respectively , compared with 1.0 % ( 0.2 % ) and 3.3 % ( 0.5 % ) in the control group ( p < .001 ) .
RESULTS	Covariate-adjusted mean composite cognitive function test scores were similar for the two groups ( p = .69 ) , and no significant differences were found for any individual cognitive test .
RESULTS	There was some evidence of a differential effect ( nominal interaction p = .008 ) for a prespecified comparison : Intensive lifestyle intervention was associated with a relative mean benefit for composite cognitive function of 0.276 ( 95 % confidence interval : 0.033 , 0.520 ) SDs among individuals with body mass index less than 30 kg/m ( 2 ) at baseline compared with a relative mean deficit of 0.086 ( -0.021 , 0.194 ) SDs among individuals with body mass more than or equal to 30 kg/m ( 2 ) .
CONCLUSIONS	Eight years of intensive lifestyle intervention did not alter cognitive function in obese adults with type 2 diabetes ; however , there was evidence for benefit among overweight but not obese individuals .
CONCLUSIONS	Changes in cognition were not assessed in this cross-sectional study .

###24931252
BACKGROUND	The occurrence of contrast induced acute kidney injury ( CIAKI ) has a pronounced impact on morbidity and mortality .
BACKGROUND	The aim of the present study was to appraise the diagnostic efficacy of age , estimated glomerular filtration rate ( eGFR ) and ejection fraction ( AGEF ) score ( age/EF ( % ) +1 ( if eGFR was < 60 ml min ( -1 ) 1.73 m ( -2 ) ) ) as an predictor of CIAKI in patients with diabetes mellitus ( DM ) and concomitant chronic kidney disease ( CKD ) .
METHODS	The AGEF score was calculated for 2 998 patients with type 2 DM and concomitant CKD who had undergone coronary/peripheral arterial angiography .
METHODS	CIAKI was defined as an increase in sCr concentration of 0.5 mg/dl ( 44.2 mmol/L ) or 25 % above baseline at 72 hours after exposure to the contrast medium .
METHODS	Post hoc analysis was performed by stratifying the rate of CIAKI according to AGEF score tertiles .
METHODS	The diagnostic efficacy of the AGEF score for predicting CIAKI was evaluated with receiver operating characteristic ( ROC ) analysis .
RESULTS	The AGEF score ranged from 0.49 to 3.09 .
RESULTS	The AGEF score tertiles were defined as follows : AGEFlow 0.92 ( n = 1 006 ) ; 0.92 < AGEFmid 1.16 ( n = 1 000 ) , and ACEFhigh > 1.16 ( n = 992 ) .
RESULTS	The incidence of CIAKI was significantly different in patients with low , middle and high AGEF scores ( AGEFlow = 1.1 % , AGEFmid = 2.3 % and AGEFhigh = 5.8 % , P < 0.001 ) .
RESULTS	By multivariate analysis , AGEF score was an independent predictor of CIAKI ( odds ratio = 4.96 , 95 % CI : 2.32-10 .58 , P < 0.01 ) .
RESULTS	ROC analysis showed that the area under the curve was 0.70 ( 95 % CI : 0.648-0 .753 , P < 0.001 ) .
CONCLUSIONS	The AGEF score is effective for stratifying risk of CIAKI in patients with DM and CKD undergoing coronary/peripheral arterial angiography .
CONCLUSIONS	( Clinical Trial identifier : NCT00786136 ) .

###26461996
OBJECTIVE	Low back pain ( LBP ) is common in primary care .
OBJECTIVE	Guidelines recommend delaying referrals for physical therapy .
OBJECTIVE	To evaluate whether early physical therapy ( manipulation and exercise ) is more effective than usual care in improving disability for patients with LBP fitting a decision rule .
METHODS	Randomized clinical trial with 220 participants recruited between March 2011 and November 2013 .
METHODS	Participants with no LBP treatment in the past 6 months , aged 18 through 60 years ( mean age , 37.4 years [ SD ,10.3 ] ) , an Oswestry Disability Index ( ODI ) score of 20 or higher , symptom duration less than 16 days , and no symptoms distal to the knee in the past 72 hours were enrolled following a primary care visit .
METHODS	All participants received education .
METHODS	Early physical therapy ( n = 108 ) consisted of 4 physical therapy sessions .
METHODS	Usual care ( n = 112 ) involved no additional interventions during the first 4 weeks .
METHODS	Primary outcome was change in the ODI score ( range : 0-100 ; higher scores indicate greater disability ; minimum clinically important difference , 6 points ) at 3 months .
METHODS	Secondary outcomes included changes in the ODI score at 4-week and 1-year follow-up , and change in pain intensity , Pain Catastrophizing Scale ( PCS ) score , fear-avoidance beliefs , quality of life , patient-reported success , and health care utilization at 4-week , 3-month , and 1-year follow-up .
RESULTS	One-year follow-up was completed by 207 participants ( 94.1 % ) .
RESULTS	Using analysis of covariance , early physical therapy showed improvement relative to usual care in disability after 3 months ( mean ODI score : early physical therapy group , 41.3 [ 95 % CI , 38.7 to 44.0 ] at baseline to 6.6 [ 95 % CI , 4.7 to 8.5 ] at 3 months ; usual care group , 40.9 [ 95 % CI , 38.6 to 43.1 ] at baseline to 9.8 [ 95 % CI , 7.9 to 11.7 ] at 3 months ; between-group difference , -3.2 [ 95 % CI , -5.9 to -0.47 ] , P = .02 ) .
RESULTS	A significant difference was found between groups for the ODI score after 4 weeks ( between-group difference , -3.5 [ 95 % CI , -6.8 to -0.08 ] , P = .045 ] ) , but not at 1-year follow-up ( between-group difference , -2.0 [ 95 % CI , -5.0 to 1.0 ] , P = .19 ) .
RESULTS	There was no improvement in pain intensity at 4-week , 3-month , or 1-year follow-up ( between-group difference , -0.42 [ 95 % CI , -0.90 to 0.02 ] at 4-week follow-up ; -0.38 [ 95 % CI , -0.84 to 0.09 ] at 3-month follow-up ; and -0.17 [ 95 % CI , -0.62 to 0.27 ] at 1-year follow-up ) .
RESULTS	The PCS scores improved at 4 weeks and 3 months but not at 1-year follow-up ( between-group difference , -2.7 [ 95 % CI , -4.6 to -0.85 ] at 4-week follow-up ; -2.2 [ 95 % CI , -3.9 to -0.49 ] at 3-month follow-up ; and -0.92 [ 95 % CI , -2.7 to 0.61 ] at 1-year follow-up ) .
RESULTS	There were no differences in health care utilization at any point .
CONCLUSIONS	Among adults with recent-onset LBP , early physical therapy resulted in statistically significant improvement in disability , but the improvement was modest and did not achieve the minimum clinically important difference compared with usual care .
BACKGROUND	clinicaltrials.gov Identifier : NCT01726803 .

###25675564
OBJECTIVE	To compare the efficacy difference in treatment of myofasical pain syndrome between sparrow-pecking moxibustion and acupuncture at trigger points so as to provide the reference of the effective therapeutic method for myofascial pain syndrome .
METHODS	Ninety patients were randomized into a sparrow-pecking moxibustion group and an acupuncture group , 45 cases in each one .
METHODS	The trigger points were selected in pain areas in the two groups .
METHODS	In the sparrow-pecking moxibustion group , the sparrow-pecking moxibustion was applied , 30 min in each time .
METHODS	In the acupuncture group , the filiform needles were inserted obliquely at 45 degrees and retained for 40 min in each treatment .
METHODS	The treatment was given once a day and 10 treatments made one session in the two groups .
METHODS	The short-form McGill pain questionnaire was used as the observation index , and the changes in pain rating index ( PRI ) , present pain intensity ( PPI ) and visual analogue scale ( VAS ) before and after treatment were used for efficacy assessment .
RESULTS	The results of PRI , PPI and VAS after treatment were reduced apparently as compared with those before treatment in the sparrow-pecking moxibustion group and the acupuncture group ( all P < 0.001 ) .
RESULTS	The differences in PRI , PPI and VAS after treatment were not significant in comparison of the two groups ( both P > 0.05 ) .
RESULTS	The curative and remarkably effective rate was 80.0 % ( 36/45 ) in the sparrow-pecking moxibustion group , which was better than 40.0 % ( 18/45 , P < 0.001 ) in the acupuncture group .
CONCLUSIONS	Sparrow-pecking moxibustion at trigger points achieves the superior efficacy on myofascial pain syndrome as compared with acupuncture at trigger points .
CONCLUSIONS	This therapy is simpler in operation additionally .

###25884986
BACKGROUND	Physical inactivity increases the risk of many chronic diseases including coronary heart disease , type 2 diabetes and some cancers .
BACKGROUND	It is recommended that adults should undertake at least 150 minutes of moderate intensity physical activity throughout the week but many adults do not achieve this .
BACKGROUND	An opportunity for working adults to accumulate the recommended activity levels is through the daily commute .
METHODS	Employees will be recruited from workplaces in south-west England and south Wales .
METHODS	In the intervention arm , workplace Walk-to-Work promoters will be recruited and trained .
METHODS	Participating employees will receive Walk-to-Work materials and support will be provided through four contacts from the promoters over 10 weeks .
METHODS	Workplaces in the control arm will continue with their usual practice .
METHODS	The intervention will be evaluated by a cluster randomized controlled trial including economic and process evaluations .
METHODS	The primary outcome is daily minutes of moderate to vigorous physical activity ( MVPA ) .
METHODS	Secondary outcomes are : overall physical activity ; sedentary time ; modal shift away from private car use during the commute ; and physical activity/MVPA during the commute .
METHODS	Accelerometers , GPS receivers and travel diaries will be used at baseline and one year follow-up .
METHODS	Questionnaires will be used at baseline , immediately post intervention , and one year follow-up .
METHODS	The process evaluation will examine the context , delivery and response to the intervention from the perspectives of employers , Walk-to-Work promoters and employees using questionnaires , descriptive statistics , fieldnotes and interviews .
METHODS	A cost-consequence study will include employer , employee and health service costs and outcomes .
METHODS	Time and consumables used in implementing the intervention will be measured .
METHODS	Journey time , household commuting costs and expenses will be recorded using travel diaries to estimate costs to employees .
METHODS	Presenteeism , absenteeism , employee wellbeing and health service use will be recorded .
CONCLUSIONS	Compared with other forms of physical activity , walking is a popular , familiar and convenient , and the main option for increasing physical activity in sedentary populations .
CONCLUSIONS	To our knowledge , this is the first full-scale randomised controlled trial to objectively measure ( using accelerometers and GPS receivers ) the effectiveness of a workplace intervention to promote walking during the commute to and from work .
BACKGROUND	ISRCTN15009100 ( 10 December 2014 ) .

###24660971
BACKGROUND	UK guidelines recommend that patients with schizophrenia are offered access to social activities , however , the impact of such interventions have not been examined in a large randomized trial .
OBJECTIVE	To investigate the effect of an activity group intervention on mental health and global functioning 12 months after randomization compared to standard care alone .
METHODS	Secondary analysis of data from the MATISSE study .
METHODS	Primary outcomes were global functioning , assessed using the Global Assessment of Functioning ( GAF ) , and mental health symptoms measured using the Positive and Negative Syndrome Scale ( PANSS ) .
RESULTS	About 140 participants were randomized to activity groups and 137 to standard care alone .
RESULTS	Follow-up data were collected from 242 ( 87 % ) participants .
RESULTS	Mental health improved significantly among those offered activity groups ( change in PANSS score = -6.0 , 95 % CI -2.3 to -9.8 ) but global functioning did not ( change in GAF score = 0.8 , 95 % CI -1.7 to 3.3 ) .
RESULTS	No significant differences were found between treatment arms .
CONCLUSIONS	Offering activity groups to patients with schizophrenia was not associated with any additional clinical benefits .
CONCLUSIONS	There was poor uptake and attendance at activity groups .
CONCLUSIONS	Interventions that aim to improve negative symptoms may be useful in enabling engagement in psychosocial interventions .

###25536254
OBJECTIVE	Hypothermia at 33.5 C for 72 hours for neonatal hypoxic ischemic encephalopathy reduces death or disability to 44 % to 55 % ; longer cooling and deeper cooling are neuroprotective in animal models .
OBJECTIVE	To determine if longer duration cooling ( 120 hours ) , deeper cooling ( 32.0 C ) , or both are superior to cooling at 33.5 C for 72 hours in neonates who are full-term with moderate or severe hypoxic ischemic encephalopathy .
METHODS	A randomized , 22 factorial design clinical trial performed in 18 US centers in the Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) Neonatal Research Network between October 2010 and November 2013 .
METHODS	Neonates were assigned to 4 hypothermia groups ; 33.5 C for 72 hours , 32.0 C for 72 hours , 33.5 C for 120 hours , and 32.0 C for 120 hours .
METHODS	The primary outcome of death or disability at 18 to 22 months is ongoing .
METHODS	The independent data and safety monitoring committee paused the trial to evaluate safety ( cardiac arrhythmia , persistent acidosis , major vessel thrombosis and bleeding , and death in the neonatal intensive care unit [ NICU ] ) after the first 50 neonates were enrolled , then after every subsequent 25 neonates .
METHODS	The trial was closed for emerging safety profile and futility analysis after the eighth review with 364 neonates enrolled ( of 726 planned ) .
METHODS	This report focuses on safety and NICU deaths by marginal comparisons of 72 hours ' vs 120 hours ' duration and 33.5 C depth vs 32.0 C depth ( predefined secondary outcomes ) .
RESULTS	The NICU death rates were 7 of 95 neonates ( 7 % ) for the 33.5 C for 72 hours group , 13 of 90 neonates ( 14 % ) for the 32.0 C for 72 hours group , 15 of 96 neonates ( 16 % ) for the 33.5 C for 120 hours group , and 14 of 83 neonates ( 17 % ) for the 32.0 C for 120 hours group .
RESULTS	The adjusted risk ratio ( RR ) for NICU deaths for the 120 hours group vs 72 hours group was 1.37 ( 95 % CI , 0.92-2 .04 ) and for the 32.0 C group vs 33.5 C group was 1.24 ( 95 % CI , 0.69-2 .25 ) .
RESULTS	Safety outcomes were similar between the 120 hours group vs 72 hours group and the 32.0 C group vs 33.5 C group , except major bleeding occurred among 1 % in the 120 hours group vs 3 % in the 72 hours group ( RR , 0.25 [ 95 % CI , 0.07-0 .91 ] ) .
RESULTS	Futility analysis determined that the probability of detecting a statistically significant benefit for longer cooling , deeper cooling , or both for NICU death was less than 2 % .
CONCLUSIONS	Among neonates who were full-term with moderate or severe hypoxic ischemic encephalopathy , longer cooling , deeper cooling , or both compared with hypothermia at 33.5 C for 72 hours did not reduce NICU death .
CONCLUSIONS	These results have implications for patient care and design of future trials .
BACKGROUND	clinicaltrials.gov Identifier : NCT01192776 .

###26268408
OBJECTIVE	To evaluate the effectiveness and safety of leuprolide acetate in the treatment of endometriosis .
METHODS	From Nov. 2007 to Oct. 2012 , the patients who confirmed to be endometriosis were randomly divided into test group of 113 cases and control group of 116 cases .
METHODS	The test drug was the sustained-release agent of leuprolide acetate .
METHODS	The control drug was Enantone .
METHODS	The drugs were used for 3 times in total .
METHODS	After treatment , the ovarian mass volumes measured with type-B ultrasound , the scores of the patient 's subjective symptoms during non-menstrual and menstruation days , the pelvic signs during non-menstrual days , the changes of hormones [ estradiol ( E2 ) , FSH , LH ] , and adverse events were observed .
RESULTS	After the treatment , the rate of changes of ovarian mass volume ( among them , at 12 weeks after the first injection , the median was -55.83 % in the test group , -68.22 % in the control group , P = 0.336 ) , the distinct improvement rate of symptom scores and pelvic signs during non-menstrual days [ among them , at 12 weeks after the first injection , the rate of lower abdomen pain was 47.5 % ( 48/101 ) in the test group , 44.0 % ( 44/100 ) in the control group , P = 0.881 ] , the hormone ( E2 , FSH , LH ) levels [ among them , at 12 weeks after the first injection , the serum level of E2 , was ( 3338 ) pmol/L in the test group , ( 3840 ) pmol/L in the control group , P = 0.414 ; the serum level of FSH , was ( 5.12.8 ) U/L in the test group , ( 5.32.3 ) U/L in the control group , P = 0.666 ; the serum level of LH , was ( 0.60.8 ) U/L in the test group , ( 0.60.9 ) U/L in the control group , P = 0.907 ] , had no statistically significant difference between the two groups ( all P > 0.05 ) .
RESULTS	The distinct improvement rate and improvement rate of symptom ( lower abdomen pain , low back pain ) scores during menstruation days at 12 weeks after the first injection , the rates of lower abdomen pain were 73.9 % ( 34/46 ) , 15.2 % ( 7/46 ) respectively in the test group , 72.3 % ( 34/47 ) , 2.1 % ( 1/47 ) respectively in the control group , had statistically significant difference between the two groups ( P = 0.026 ) .
RESULTS	There was no serious adverse event occurred in both two groups .
RESULTS	The incidence rate of adverse event was 33.6 % ( 38/113 ) in test group , 23.2 % ( 27/116 ) in control group , there was no significant difference between the two groups ( P = 0.082 ) .
CONCLUSIONS	Leuprolide acetate is effective and safe in the treatment of endometriosis .

###24888540
OBJECTIVE	To determine whether home-use icterometry improves parental recognition of neonatal jaundice , early care seeking and treatment to minimize risks of bilirubin encephalopathy .
METHODS	Cluster-randomised controlled trial of community-level icterometry used at home by mothers in Chi Linh , Vietnam .
METHODS	Rural health-care workers identified and enrolled term newborns .
METHODS	Post-partum mothers received jaundice education and icterometry instructions and were cluster-randomised by commune .
METHODS	Cases received icterometers ( icterometer group ( IG ) ) and controls did not ( control group ( CG ) ) .
METHODS	Subjects received mobile telephone calls from post-natal days 2-7 to determine maternal recognition by visual inspection and icterometer detection of jaundice ( 3.0 on five-point scale ) .
METHODS	Mothers without telephones , premature newborns ( < 35 weeks ) or newborns hospitalised > 5 days were excluded .
RESULTS	Three hundred fifty-two subjects were enrolled ( 183 IG and 169 CG ) , of whom 11 ( 3.4 % ) were lost to telephone follow-up .
RESULTS	Jaundice was recognised and/or detected in 94 ( 27 % ) of all newborns .
RESULTS	Icterometry helped 11 mothers ( 6 % ) detect neonatal jaundice that was not visually recognised by IG mothers .
RESULTS	Detection by IG mothers was not statistically greater than CG mothers ( P = 0.09 ) .
RESULTS	Follow-up care seeking was 8 % in both groups ( P = 0.2 ) , and 11 % of jaundiced newborns received treatment ( 9 % IG vs. 16 % CG , P = 0.3 ) .
RESULTS	Newborns who received care had bilirubin measurements that averaged 257 mol/L IG vs. 322 mol/L CG ( P = 0.3 ) .
RESULTS	There were no deaths .
CONCLUSIONS	In this pilot study , home-use icterometry may help improve parental detection of jaundice in rural Vietnam .
CONCLUSIONS	However , larger studies are necessary to determine the changes in recognition , care seeking and treatment .

###24253834
BACKGROUND	In people with obesity hypoventilation syndrome ( OHS ) , breathing 100 % oxygen increases carbon dioxide ( PCO2 ) , but its effect on pH is unknown .
BACKGROUND	This study investigated the effects of moderate concentrations of supplemental oxygen on PCO2 , pH , minute ventilation ( VE ) and physiological dead space to tidal volume ratio ( VD/VT ) among people with stable untreated OHS , with comparison to healthy controls .
METHODS	In a double-blind randomised crossover study , participants breathed oxygen concentrations ( FiO2 ) 0.28 and 0.50 , each for 20 min , separated by a 45 min washout period .
METHODS	Arterialised-venous PCO2 ( PavCO2 ) and pH , VE and VD/VT were measured at baseline , then every 5 min .
METHODS	Data were analysed using general linear model analysis .
RESULTS	28 participants were recruited ( 14 OHS , 14 controls ) .
RESULTS	Among OHS participants ( mean SD arterial PCO2 6.7 0.5 kPa ; arterial oxygen 8.9 1.4 kPa ) FiO2 0.28 and 0.50 maintained oxygen saturation 98-100 % .
RESULTS	After 20 min of FiO2 0.28 , PavCO2 change ( PavCO2 ) was 0.3 0.2 kPa ( p = 0.013 ) , with minimal change in VE and rises in VD/VT of 1 5 % ( p = 0.012 ) .
RESULTS	FiO2 0.50 increased PavCO2 by 0.5 0.4 kPa ( p = 0.012 ) , induced acidaemia and increased VD/VT by 3 3 % ( p = 0.012 ) .
RESULTS	VE fell by 1.2 2.1 L/min within 5 min then recovered individually to varying degrees .
RESULTS	A negative correlation between VE and PavCO2 ( r = -0.60 , p = 0.024 ) suggested that ventilatory responses were the key determinant of PavCO2 rises .
RESULTS	Among controls , FiO2 0.28 and 0.50 did not change PavCO2 or pH , but FiO2 0.50 significantly increased VE and VD/VT .
CONCLUSIONS	Commonly used oxygen concentrations caused hypoventilation , PavCO2 rises and acidaemia among people with stable OHS .
CONCLUSIONS	This highlights the potential dangers of this common intervention in this group .

###25554072
BACKGROUND	Fish and meat intake may affect gestational weight gain , body composition and serum fatty acids .
BACKGROUND	We aimed to determine whether a longitudinal dietary intervention during pregnancy could increase fish intake , affect serum phospholipid fatty acids , gestational weight gain and body composition changes during pregnancy in women of normal weight participating in the Pregnancy Obesity Nutrition and Child Health study .
BACKGROUND	A second aim was to study possible effects in early pregnancy of fish intake and meat intake , respectively , on serum phospholipid fatty acids , gestational weight gain , and body composition changes during pregnancy .
METHODS	In this prospective , randomized controlled study , women were allocated to a control group or to a dietary counseling group that focused on increasing fish intake .
METHODS	Fat mass and fat-free mass were measured by air-displacement plethysmography .
METHODS	Reported intake of fish and meat was collected from a baseline population and from a subgroup of women who participated in each trimester of their pregnancies .
METHODS	Serum levels of phospholipid arachidonic acid ( s-ARA ) , eicosapentaenoic acid ( s-EPA ) , and docosahexaenoic acid ( s-DHA ) were measured during each trimester .
RESULTS	Weekly fish intake increased only in the intervention group ( n = 18 ) from the first to the second trimester ( median difference 113g , p = 0.03 ) and from the first to the third trimester ( median difference 75g , p = 0.01 ) .
RESULTS	In the first trimester , fish intake correlated with s-EPA ( r = 0.36 , p = 0.002 , n = 69 ) and s-DHA ( r = 0.34 , p = 0.005 , n = 69 ) , and meat intake correlated with s-ARA ( r = 0.28 , p = 0.02 , n = 69 ) .
RESULTS	Fat-free mass gain correlated with reported meat intake in the first trimester ( r = 0.39 , p = 0.01 , n = 45 ) .
CONCLUSIONS	Dietary counseling throughout pregnancy could help women increase their fish intake .
CONCLUSIONS	Intake of meat in early pregnancy may increase the gain in fat-free mass during pregnancy .

###25391601
BACKGROUND	Physical inactivity is a significant risk factor for cardiovascular disease and remains highly prevalent in middle-aged women .
OBJECTIVE	We hypothesized that an interventionist-led ( IL ) , primary-care-based physical activity ( PA ) and weight loss intervention would increase PA levels and decrease weight to a greater degree than a self-guided ( SG ) program .
METHODS	We conducted a randomized trial .
METHODS	Ninety-nine inactive women aged 45-65 years and with BMI 25 kg/m ( 2 ) were recruited from three primary care clinics .
METHODS	The interventionist-led ( IL ) group ( n = 49 ) had 12 weekly sessions of 30 min discussions with 30 min of moderate-intensity PA. .
METHODS	The self-guided ( SG ) group ( n = 50 ) received a manual for independent use .
METHODS	Assessments were conducted at 0 , 3 , and 12 months ; PA and weight were primary outcomes .
METHODS	Weight was measured with a standardized protocol .
METHODS	Leisure PA levels were assessed using the Modifiable Activity Questionnaire .
METHODS	Differences in changes by group were analyzed with a t-test or Wilcoxon rank-sum test .
METHODS	Mixed models were used to analyze differences in changes of outcomes by group , using an intention-to-treat principle .
RESULTS	Data from 98 women were available for analysis .
RESULTS	At baseline , mean ( SD ) age was 53.9 ( 5.4 ) years and 37 % were black .
RESULTS	Mean weight was 92.3 ( 17.7 ) kg and mean BMI was 34.7 ( 5.9 ) kg/m ( 2 ) .
RESULTS	Median PA level was 2.8 metabolic equivalent hours per week ( MET-hour/week ) ( IQR 0.0 , 12.0 ) .
RESULTS	At 3 months , IL women had a significantly greater increase in PA levels ( 7.5 vs. 1.9 MET-hour/week ; p = 0.02 ) than SG women ; there was no significant difference in weight change .
RESULTS	At 12 months , the difference between groups was no longer significant ( 4.7 vs. 0.7 MET-hour/week ; p = 0.38 ) .
RESULTS	Mixed model analysis showed a significant ( p = 0.048 ) difference in PA change between groups at 3 months only .
CONCLUSIONS	The IL intervention was successful in increasing the physical activity levels of obese , inactive middle-aged women in the short-term .
CONCLUSIONS	No significant changes in weight were observed .

###24814167
OBJECTIVE	To determine the intravitreal anti-vascular endothelial growth factor ( VEGF ) injection techniques and preferences within the retinal community and to identify potential factors associated with the development of sustained intraocular pressure ( IOP ) elevation in patients treated with intravitreal anti-VEGF therapy for neovascular age-related macular degeneration ( AMD ) .
METHODS	Cross-sectional physician survey .
METHODS	Five hundred and thirty retina specialists spanning both private and academic practices were surveyed regarding current anti-VEGF intravitreal injection protocols , including the anti-VEGF drug of choice , needle gauge , injection volume , injection technique , and self-reported prevalence of sustained IOP elevation .
METHODS	Multivariate logistic regressions were performed to assess the potential influence of these factors on long-term IOP .
RESULTS	Two hundred ninety-two specialists ( 55 % ) reported believing that intravitreal anti-VEGF therapy may cause sustained IOP elevation .
RESULTS	Of these responses , the most common reported prevalence was 1 % -2 % ( 48 % ) , followed by 3 % -5 % ( 34 % ) .
RESULTS	There was no relationship between the frequency of sustained IOP elevation and anti-VEGF drug of choice .
RESULTS	Physicians who injected greater than 0.05 cc in less than 1 second were 5.56 times more likely to observe a high frequency of sustained IOP elevation ( P = .006 , 95 % CI 1.64-18 .89 ) .
CONCLUSIONS	Based on physician survey data , serial anti-VEGF injections using higher injection volumes with a rapid injection technique may potentially lead to sustained IOP elevation .
CONCLUSIONS	The underlying mechanism for this complication may be injury to the trabecular meshwork resulting from rapid elevations in IOP .
CONCLUSIONS	Further investigation of the relationship between injection techniques and sustained IOP elevation in the form of retrospective or prospective clinical studies is warranted .

###25499944
BACKGROUND	Purified palmitoleic acid ( 16-1 ; omega-7 ) has shown lipid-lowering and anti-inflammatory benefits in open label , epidemiologic , and animal studies .
OBJECTIVE	Our objective was to perform the first randomized controlled trial of purified palmitoleic acid supplementation in humans .
METHODS	Adults with dyslipidemia and evidence of mild systemic inflammation ( high-sensitivity C-reactive protein [ hs-CRP ] between 2 and 5mg/L ) were randomly allocated to receive either 220.5 mg of cis-palmitoleic acid ( n = 30 ) or an identical capsule with placebo ( 1000mg of medium chain triglycerides , n = 30 ) once per day for 30days .
METHODS	Participants were asked to maintain their current diet .
METHODS	Serum lipids and hs-CRP were drawn at baseline and study completion .
RESULTS	At 30days , there were significant mean ( 95 % confidence interval [ CI ] ) reductions in CRP ( -1.9 [ -2.3 to -1.4 ] mg/L ) , triglyceride ( -30.2 [ -40.2 to -25.3 ] mg/dL ) , and low-density lipoprotein ( LDL ) ( -8.9 [ -12.0 to -5.8 ] mg/dL ) , and a significant increase in high-density lipoprotein ( HDL ) ( 2.4 [ 1.5 , 3.3 ] mg/dL ) in the intervention group compared with control .
RESULTS	These changes equated to 44 % , 15 % , and 8 % reductions in CRP , triglyceride , and LDL respectively , and a 5 % increase in HDL compared with control .
CONCLUSIONS	Purified palmitoleic acid may be useful in the treatment of hypertriglyceridemia with the beneficial added effects of decreasing LDL and hs-CRP and raising HDL .
CONCLUSIONS	Further study is needed to elucidate mechanisms and establish appropriate human doses .

###24640440
OBJECTIVE	This double-blind , crossover study evaluated whole plaque fluoride concentration ( F ) , as well as whole plaque calcium concentrations ( Ca ) after brushing with a placebo ( PD - fluoride free ) , low-fluoride ( LFD , 513 microg F/g ) and conventional ( CD , 1,072 microg F/g ) dentifrices .
METHODS	Children ( n = 20 ) were randomly assigned to brush twice daily with one of the dentifrices , during 7 days .
METHODS	On the 7th day , samples were collected at 1 and 12 hours after brushing .
METHODS	F and Ca were analyzed with an ion-selective electrode and with the Arsenazo III method , respectively .
METHODS	Data were analyzed by ANOVA , Tukey 's test and by Pearson correlation coefficient ( P < 0.05 ) .
RESULTS	The use of the fluoridated dentifrices significantly increased plaque [ F ] s 1 hour after brushing when compared to PD , returning to baseline levels 12 hours after .
RESULTS	Positive and significant correlations were found between plaque [ F ] and ( Ca ) under most of the conditions evaluated .
RESULTS	The mean increase in plaque [ F ] observed 1 hour after brushing with the CD were only about 47 % higher than those obtained for the LFD .
RESULTS	The use of a LFD promotes proportionally higher increases in plaque [ F ] when compared to a CD .
RESULTS	Plaque F concentrations were also shown to be dependent on plaque Ca concentrations .

###25300431
BACKGROUND	Transcutaneous electrical nerve stimulation ( TENS ) is a useful modality for pain control .
BACKGROUND	TENS has recently been applied to decrease spasticity .
BACKGROUND	The purpose of this study is to determine whether the addition of TENS to an exercise program reduces spasticity and improves balance and gait in chronic stroke patients .
METHODS	This was a single-blinded , multicenter , randomized controlled trial .
METHODS	Thirty-four ambulatory individuals with chronic stroke participated and were randomly allocated to the TENS or Placebo group .
METHODS	The TENS group performed therapeutic exercise with TENS while the placebo ( non-stimulation ) TENS group performed therapeutic exercise with placebo TENS .
METHODS	Participants in both groups followed the same 30-min exercise regimen 5 times per week for a period of 6 weeks .
METHODS	Spasticity ( modified Ashworth scale ) , static ( balance system ) , and dynamic balance ( timed up and go test ) , and gait ability ( gait analyzer ) were measured at 1 week before and 1 week after the intervention .
RESULTS	Significant differences were observed between the 2 groups .
RESULTS	Spasticity improved by 0.80 points in the TENS group .
RESULTS	Anterior-posterior and medial-lateral sway velocity among static balance parameters and dynamic balance showed significant differences between the TENS and Placebo TENS groups ( p = .000 ) .
RESULTS	Gait speed and cadence were enhanced significantly in the TENS group ( p = .000 ) .
RESULTS	Step and stride length on the paretic side showed a significant difference in the TENS group ( p = .000 ) , while only velocity showed a significant difference in the Placebo TENS group ( p = .004 ) .
CONCLUSIONS	A combination of therapeutic exercise and TENS may reduce spasticity and improve balance , gait , and functional activity in chronic stroke patients .

###24341049
BACKGROUND	Tight blood glucose control has become a therapeutical goal for anesthetic management for patients scheduled for cardiac surgery , especially if they are diabetic patients .
OBJECTIVE	This study was created to confirm the benefits of intraoperative GIK solution usage during coronary bypass operation of diabetic patients .
METHODS	Patients with type 1 and 2 diabetes mellitus ( DM ) referred for coronary artery bypass grafting ( CABG ) were randomized to receive GIK solution ( GIK -- study group ) in the first 24 hours intraoperatively or to receive official Clinical protocol without GIK solution ( non GIK - control group ) .
METHODS	The primary clinical outcome was the cardiac index ( CI ) since it represents the most sensitive measure of cardiac work in the immediate postoperative period , and the secondary clinical outcomes were the glycemic control , insulin consumption , duration of mechanical ventilation ( MV ) , potassium level and atrial fibrillation ( AF ) appearance .
RESULTS	One hundred diabetic patients , divided into two groups , were included in the study .
RESULTS	The cardiac index did not show a significant difference , although the study group had CI with only minor variations than those of the controlled group , hence the reason we considered the study group as the more stable .
RESULTS	The atrial fibrillation showed a difference between two groups , with 14 ( 28 % ) patients with postoperative AF in the control group compared with 3 ( 6 % ) patients with postoperative AF in the study group .
RESULTS	As potassium values were stable in study group , we concluded that it can be one of the reasons for less postoperative AF in this group .
RESULTS	The duration of MV showed a significant difference ( 0,003 ) between the two groups as well .
RESULTS	In the study group the average MV time was 534,38 minutes , compared with the control group with 749,20 minutes .
RESULTS	The average value of glucose was 11.1 mmol/l in the control group vs. 9.8 mmol/l in the study group .
RESULTS	The study group had less insulin consumption in order to maintain target glycemia ( p = 0.001 ) .
RESULTS	In the non GIK group average insulin consumption was 44 IJ per patient vs. 28.5 IJ in the GIK group .
CONCLUSIONS	Intraoperative GIK solution given to diabetic patients with CABG operation provides more stable CI , shorter time of MV , more stable values of potassium which provides normal rhythm and less AF onset , less insulin to maintain target glycemia .
CONCLUSIONS	All the above mentioned provides more stable intraoperative hemodynamic and better recovery of diabetic

###25074944
BACKGROUND	High-intensity noninvasive ventilation ( HI-NIV ) is the most effective means of improving several physiological and clinical parameters in subjects with chronic hypercapnic COPD .
BACKGROUND	Whether the newer hybrid mode using target tidal volume noninvasive ventilation ( target V ( T ) NIV ) provides additional benefits remains unclear .
METHODS	Subjects with COPD successfully established on long-term HI-NIV were switched to target V ( T ) NIV .
METHODS	Optimal target V ( T ) settings according to nocturnal transcutaneous P ( CO2 ) measurements were achieved following a randomized crossover trial using 8 mL/kg ideal body weight and 110 % of individual V ( T ) during HI-NIV , respectively .
METHODS	The following parameters were compared at the beginning of the trial while subjects were on HI-NIV , and after 3 months on optimal target V ( T ) NIV : sleep quality by polysomnography , overnight gas exchange , subjects ' tolerance , overnight pneumotachygraphic measurements during NIV , health-related quality of life ( severe respiratory insufficiency questionnaire ) , exercise capacity ( 6-min walk test ) , and lung function .
RESULTS	Ten of 14 subjects completed the study .
RESULTS	There were no differences between HI-NIV and target V ( T ) NIV in any of the above-mentioned parameters .
RESULTS	Specifically , the mean overnight transcutaneous P ( CO2 ) was equivalent under each form of ventilation ( both 45 5 mm Hg , P = .75 ) .
CONCLUSIONS	Switching subjects from well-established HI-NIV to target V ( T ) NIV shows no clinical benefits in chronic hypercapnic COPD .
CONCLUSIONS	In particular , sleep quality , the control of nocturnal hypoventilation , daytime hypercapnia , overnight ventilation patterns , subjects ' tolerance , health-related quality of life , lung function , and exercise capability were all similar in subjects who underwent HI-NIV and target V ( T ) NIV .
CONCLUSIONS	Nevertheless , target V ( T ) NIV might offer some physiological advantages in breathing pattern and might be beneficial in some individual patients .
CONCLUSIONS	( German Clinical Trials Register [ www.drks.de ] Registration DRKS00000450 . )

###25989386
OBJECTIVE	Patients with cirrhosis and variceal hemorrhage have a high risk of rebleeding .
OBJECTIVE	We performed a prospective randomized trial to compare the prevention of rebleeding in patients given a small-diameter covered stent vs those given hepatic venous pressure gradient ( HVPG ) - based medical therapy prophylaxis .
METHODS	We performed an open-label study of patients with cirrhosis ( 92 % Child class A or B , 70 % alcoholic ) treated at 10 medical centers in Germany .
METHODS	Patients were assigned randomly more than 5 days after variceal hemorrhage to groups given a small covered transjugular intrahepatic portosystemic stent-shunt ( TIPS ) ( 8 mm ; n = 90 ) , or medical reduction of portal pressure ( propranolol and isosorbide-5-mononitrate ; n = 95 ) .
METHODS	HVPG was determined at the time patients were assigned to groups ( baseline ) and 2 weeks later .
METHODS	In the medical group , patients with an adequate reduction in HVPG ( responders ) remained on the drugs whereas nonresponders underwent only variceal band ligation .
METHODS	The study was closed 10 months after the last patient was assigned to a group .
METHODS	The primary end point was variceal rebleeding .
METHODS	Survival , safety ( adverse events ) , and quality of life ( based on the Short Form-36 health survey ) were secondary outcome measures .
RESULTS	A significantly smaller proportion of patients in the TIPS group had rebleeding within 2 years ( 7 % ) than in the medical group ( 26 % ) ( P = .002 ) .
RESULTS	A slightly higher proportion of patients in the TIPS group experienced adverse events , including encephalopathy ( 18 % vs 8 % for medical treatment ; P = .05 ) .
RESULTS	Rebleeding occurred in 6 of 23 patients ( 26 % ) receiving medical treatment before hemodynamic control was possible .
RESULTS	Per-protocol analysis showed that rebleeding occurred in a smaller proportion of the 32 responders ( 18 % ) than in nonresponders who received variceal band ligation ( 31 % ) ( P = .06 ) .
RESULTS	Fifteen patients from the medical group ( 16 % ) underwent TIPS placement during follow-up evaluation , mainly for refractory ascites .
RESULTS	Survival time and quality of life did not differ between both randomized groups .
CONCLUSIONS	Placement of a small-diameter , covered TIPS was straightforward and prevented variceal rebleeding in patients with Child A or B cirrhosis more effectively than drugs , which often required step-by-step therapy .
CONCLUSIONS	However , TIPS did not increase survival time or quality of life and produced slightly more adverse events .
CONCLUSIONS	Clinical Trial no : ISRCTN 16334693 .

###25841539
OBJECTIVE	To assess the effects of daily consumption of a synbiotic yogurt drink on the health , growth , and quality of life of healthy children 12-48 months of age in out-of-home child care .
METHODS	Healthy children attending child care centers were enrolled in a prospective , double-blind , placebo-controlled clinical trial .
METHODS	The intervention was a yogurt drink containing Streptococcus thermophilus , Lactobacillus bulgaricus , and Bifidobacterium animalis subspecies lactis ( BB-12 ) ( 5 10 ( 9 ) cfu/100 mL serving ) , and 1 g of inulin ( synbiotic group ) vs a similar nonsynbiotic-containing acidified milk drink ( placebo group ) once daily for 16 weeks .
METHODS	The end points were days of diarrhea , fever , vomiting , symptoms of upper respiratory tract infection , use of antibiotics , physician visits , child care absenteeism , parental work absenteeism , and quality of life ( PedsQL 4.0 ; Mapi Research Trust , Lyon , France ) .
RESULTS	Compared with placebo ( n = 73 ) , children receiving synbiotic ( n = 76 ) had significantly fewer days of reported fever ( 1.85 vs 1.95 , P < .05 ) , significant improvement in social functioning ( P < .035 ; pre-to-end intervention ) , and school functioning ( P < .045 ; pre-to-mid intervention ) .
RESULTS	More days with 3 loose/watery stools were reported in the synbiotic group ( P < .05 ) .
CONCLUSIONS	Daily supplementation of children 's diet with yogurt containing probiotic bacteria BB-12 and inulin significantly reduced days of fever and improved social and school functioning .
CONCLUSIONS	The increased frequency of bowel movements may be explained by an accelerating effect of BB-12 and inulin on intestinal transit .
CONCLUSIONS	Further research on the possible benefits of synbiotics on children 's health is advised .
BACKGROUND	ClinicalTrials.gov : NCT00653705 .

###24633761
OBJECTIVE	In older adults with anxiety disorders , chronically elevated cortisol may contribute to cognitive impairment and elevated anxiety .
OBJECTIVE	We conducted a pilot study with mifepristone , a glucocorticoid receptor antagonist , as a potential treatment for late-life anxiety disorders and co-occurring cognitive dysfunction .
METHODS	Fifteen individuals 60years and older with an anxiety disorder plus cognitive dysfunction participated in the 12-week study .
METHODS	In the first week , participants were randomly assigned to mifepristone 300mg daily or placebo .
METHODS	In the subsequent 3weeks , all participants received mifepristone 300mg .
METHODS	Mifepristone was then discontinued , and the participants were reassessed 8weeks later .
METHODS	We examined the following : ( 1 ) cognitive changes ; ( 2 ) worry symptom severity ; ( 3 ) safety and tolerability ; and ( 4 ) salivary cortisol before , during , and after mifepristone exposure .
RESULTS	Overall safety , tolerability , and high retention supported the feasibility of this research .
RESULTS	Participants with higher baseline cortisol levels ( peak cortisol > 6.0 ng/ml , n = 5 ) showed improvements in memory , executive function , and worry severity after 3-4weeks of mifepristone with persistent memory and worry improvements 8weeks after mifepristone discontinuation .
RESULTS	Individuals with low-to-normal baseline cortisol ( n = 8 ) showed little to no improvement .
RESULTS	As expected , cortisol levels rose during mifepristone exposure and returned to pretreatment levels 8weeks after mifepristone discontinuation .
RESULTS	In the first week of treatment , there were no differences between placebo-treated and mifepristone-treated participants .
CONCLUSIONS	The results of this pilot study warrant further testing of antiglucocorticoid agents in late-life anxiety disorders with co-occurring cognitive dysfunction .
CONCLUSIONS	Mifepristone is hypothesized to have benefits in patients with evidence of glucocorticoid excess .
CONCLUSIONS	Directions for further study are discussed .

###25486673
BACKGROUND	Low physical activity is a major risk factor for several age-related diseases .
BACKGROUND	Recently , we showed in a randomized controlled trial that a 12-week Web-based intervention ( Philips DirectLife ) to increase physical activity was effective in increasing physical activity levels and metabolic health in an inactive population aged 60-70 years .
OBJECTIVE	The goal of this paper was to assess how many participants successfully reached the physical activity level as targeted by the intervention and what the effects of the intervention on body composition and metabolic health in these successful individuals were to provide insight in the maximum attainable effect of the intervention .
METHODS	Among the 235 participants in a randomized controlled trial of the Actief en Gezond Oud ( AGO ) study , we assessed the effects of the intervention on metabolic parameters in those who had successfully reached their personalized physical activity target compared with the entire intervention group .
METHODS	Furthermore , we studied the dose-response effect of increase in physical activity on metabolic outcome within the intervention group .
RESULTS	Of the intervention group , 50 of 119 ( 42.0 % ) participants successfully reached the physical activity target ( corresponding to a 10 % increased daily physical activity on average ) .
RESULTS	This group showed markedly higher effects of the intervention compared to the entire intervention group , with greater decreases in body weight ( 2.74 vs 1.49 kg ) , waist circumference ( 3.74 vs 2.33 cm ) , insulin resistance ( HOMA index : 0.23 vs 0.20 ) , and in cholesterol/HDL ratio ( 0.39 vs 0.20 ) and Framingham risk score ( 0.90 % vs 0.54 % ) .
RESULTS	We found that men compared to women were more likely to be successful .
RESULTS	The dose-response analysis showed that there was a significant association between increase in minutes spent in moderate-to-vigorous activity and body weight loss , BMI reduction , waist circumference reduction , HDL cholesterol increasing , and cholesterol/HDL ratio lowering .
CONCLUSIONS	Of the intervention group , 42.0 % ( 50/119 ) reached their daily physical activity end goal , which was associated with a markedly better effect on body composition and metabolic health compared to the effect in the entire intervention group .
CONCLUSIONS	In this population , men are more likely to be successful in increasing physical activity .
CONCLUSIONS	Findings demonstrate that improving the effect of such physical activity interventions requires finding new ways to increase the proportion of the population reaching the targeted goal .
BACKGROUND	Dutch Trial Registry : NTR 3045 ; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3045 ( Archived by WebCite at http://www.webcitation.org/6KPw52dCc ) .

###24908596
OBJECTIVE	The aim of this clinical study was to determine the efficacy of Uncaria tomentosa ( cat 's claw ) against denture stomatitis ( DS ) .
METHODS	Fifty patients with DS were randomly assigned into 3 groups to receive 2 % miconazole , placebo , or 2 % U tomentosa gel .
METHODS	DS level was recorded immediately , after 1 week of treatment , and 1 week after treatment .
METHODS	The clinical effectiveness of each treatment was measured using Newton 's criteria .
METHODS	Mycologic samples from palatal mucosa and prosthesis were obtained to determinate colony forming units per milliliter ( CFU/mL ) and fungal identification at each evaluation period .
RESULTS	Candida species were identified with HiCrome Candida and API 20C AUX biochemical test .
RESULTS	DS severity decreased in all groups ( P < .05 ) .
RESULTS	A significant reduction in number of CFU/mL after 1 week ( P < .05 ) was observed for all groups and remained after 14 days ( P > .05 ) .
RESULTS	C albicans was the most prevalent microorganism before treatment , followed by C tropicalis , C glabrata , and C krusei , regardless of the group and time evaluated .
RESULTS	U tomentosa gel had the same effect as 2 % miconazole gel .
CONCLUSIONS	U tomentosa gel is an effective topical adjuvant treatment for denture stomatitis .

###26095263
OBJECTIVE	To explore whether cataract surgery contributes to the progression of wet age-related macular degeneration ( wet AMD ) .
METHODS	Retrospective cohort study .
METHODS	Retrospective review was performed of consecutive patients with wet AMD who underwent cataract surgery at the midpoint of a 1-year study window .
METHODS	A control arm included wet AMD eyes treated with anti-vascular endothelial growth factor ( VEGF ) injections that did not undergo cataract surgery for a 1-year period .
METHODS	Best-corrected visual acuity ( BCVA ) , number of anti-VEGF injections , and optical coherence tomography ( OCT ) features were compared between the 2 arms .
RESULTS	Forty eyes in the surgical group and 42 in the nonsurgical group were included .
RESULTS	BCVA was equivalent in the first half of the study , and became significantly better in the surgical group vs the nonsurgical group ( 0.23 0.65 vs 0.11 0.59 logMAR improvement , P = .049 ) .
RESULTS	There was no change in the number of injections given 6months before vs after the midpoint in the surgical group ( P = .921 ) .
RESULTS	The mean OCT central retinal thickness became greater in postsurgical eyes compared to nonsurgical eyes ( 265.4 98.4 m vs 216.4 58.3 m , P = .011 ) .
RESULTS	Surgical eyes were more likely to develop new or worse cystoid changes after the study midpoint ( 13 surgical eyes [ 54.2 % ] vs 9 nonsurgical eyes [ 28.1 % ] , P = .048 ) .
CONCLUSIONS	Cataract surgery leads to vision improvement and does not appear to contribute to worsening of wet AMD .
CONCLUSIONS	However , anatomic changes based on OCT analysis suggest a subclinical susceptibility to postoperative cystoid macular edema or exacerbation of choroidal neovascularization .

###24660604
OBJECTIVE	To assess the efficacy and safety of Reduning injection for fever , rash , and ulcers in children with mild hand , foot , and mouth disease ( HFMD ) .
METHODS	A stratified-block randomized , double-blind , parallel-controlled , and multicenter clinical trial was conducted with 360 patients in five hospitals across China : Quanzhou Children 's Hospital , Shijiazhuang No. 5 Hospital , Shanghai Public Health Centre , Hunan Provincial Children 's Hospital , and Kaifeng Children 's Hospital .
METHODS	Patients were randomized into three groups with 120 in each .
METHODS	Group A was treated with Western Medicine , group B with Reduning injection , a Chinese herbal medicine , and group C with both Reduning injection and Western Medicine .
METHODS	Results were compared for treatment efficacy and safety on HFMD .
METHODS	The clinical outcomes were observed as follows : fever and onset time of antifebrile effect ( time to bring the body temperature down > or = 0.5 degrees C after medication ) ; cumulative time for fever recovery ( body temperature recovering to normal and lasting more than 24 h without medication ) ; cumulative time for rash disappearance ( without new rashes or ulcers appearing and the original ones fading away ) ; and cumulative time for mouth ulcer disappearance .
RESULTS	For the onset time of the antifebrile effect , there was no statistical difference between groups A and B ( P > 0.05 ) and groups B and C ( P > 0.05 ) .
RESULTS	However , there was a statistical difference between groups A and C ( P < 0.05 ) , and the effect in group C was the best .
RESULTS	For the cumulative time for rash disappearance , there was no statistical difference between groups A and B ( P > 0.05 ) .
RESULTS	There were statistical differences between groups A and C , and groups B and C ( P < 0.05 ) , and the effect in group C was the best .
RESULTS	For the cumulative time for mouth ulcers disappearance , there were no statistical differences among the three groups ( P > 0.05 ) .
CONCLUSIONS	Reduning injection with Western Medicine for symptomatic treatment is most effective for mild HFMD .
CONCLUSIONS	No adverse reactions were observed .

###25227174
BACKGROUND	Oral feedback from clinical educators is the traditional teaching method for improving clinical consultation skills in medical students .
BACKGROUND	New approaches are needed to enhance this teaching model .
BACKGROUND	Multisource feedback is a commonly used assessment method for learning among practising clinicians , but this assessment has not been explored rigorously in medical student education .
BACKGROUND	This study seeks to evaluate if additional feedback on patient satisfaction improves medical student performance .
METHODS	The Patient Teaching Associate ( PTA ) Feedback Study is a single site randomized controlled , double-blinded trial with two parallel groups.An after-hours general practitioner clinic in Victoria , Australia , is adapted as a teaching clinic during the day .
METHODS	Medical students from two universities in their first clinical year participate in six simulated clinical consultations with ambulatory patient volunteers living with chronic illness .
METHODS	Eligible students will be randomized in equal proportions to receive patient satisfaction score feedback with the usual multisource feedback and the usual multisource feedback alone as control .
METHODS	Block randomization will be performed .
METHODS	We will assess patient satisfaction and consultation performance outcomes at baseline and after one semester and will compare any change in mean scores at the last session from that at baseline .
METHODS	We will model data using regression analysis to determine any differences between intervention and control groups .
METHODS	Full ethical approval has been obtained for the study .
METHODS	This trial will comply with CONSORT guidelines and we will disseminate data at conferences and in peer-reviewed journals .
CONCLUSIONS	This is the first proposed trial to determine whether consumer feedback enhances the use of multisource feedback in medical student education , and to assess the value of multisource feedback in teaching and learning about the management of ambulatory patients living with chronic conditions .
BACKGROUND	Australian New Zealand Clinical Trials Registry ( ANZCTR ) : ACTRN12613001055796 .

###24628824
BACKGROUND	Genetic information given to an individual newly diagnosed with a genetic condition is likely to have important health implications for other family members .
BACKGROUND	The task of communicating with these relatives commonly falls to the newly diagnosed person .
BACKGROUND	Talking to relatives about genetic information can be challenging and is influenced by many factors including family dynamics .
BACKGROUND	Research shows that many relatives remain unaware of relevant genetic information and the possible impact on their own health .
BACKGROUND	This study aims to evaluate whether a specific genetic counselling intervention for people newly diagnosed with a genetic condition , implemented over the telephone on a number of occasions , could increase the number of at-risk relatives who make contact with genetics services after a new genetic diagnosis within a family .
METHODS	This is a prospective , multi-centre randomised controlled trial being conducted at genetics clinics at five public hospitals in Victoria , Australia .
METHODS	A complex genetic counselling intervention has been developed specifically for this trial .
METHODS	Probands ( the first person in a family to present with a diagnosis of a genetic condition ) are being recruited and randomised into one of two arms - the telephone genetic counselling intervention arm and the control arm receiving usual care .
METHODS	The number of at-risk relatives for each proband will be estimated from a family pedigree collected at the time of diagnosis .
METHODS	The primary outcome will be measured by comparing the proportion of at-risk relatives in each arm of the trial who make subsequent contact with genetics services .
CONCLUSIONS	This study , the first randomised controlled trial of a complex genetic counselling intervention to enhance family communication , will provide evidence about how best to assist probands to communicate important new genetic information to their at-risk relatives .
CONCLUSIONS	This will inform genetic counselling practice in the context of future genomic testing .
BACKGROUND	Australia and New Zealand Clinical Trials Register ( ANZCTR ) : ANZCTRN12608000642381 .

###25932840
OBJECTIVE	To evaluate the efficacy of device-guided slow-paced respiration for reducing the frequency and severity of menopausal hot flushes .
METHODS	Perimenopausal or postmenopausal women reporting four or more hot flushes per day were recruited into a parallel-group , randomized trial of slow-paced respiration using a portable guided-breathing device .
METHODS	Women were randomly assigned to use a standard device to practice slowing their resting breathing rate to less than 10 breaths per minute for at least 15 minutes everyday or use an identical-appearing control device programmed to play relaxing nonrhythmic music while monitoring spontaneous breathing .
METHODS	The primary outcome , change in hot flush frequency over 12 weeks , was assessed using data from validated 7-day diaries abstracted by blinded analysts .
RESULTS	Among the 123 participants , mean age was 53.4 ( 3.4 ) years .
RESULTS	Women reported an average of 8.5 ( 3.5 ) hot flushes per day at baseline .
RESULTS	After 12 weeks , women randomized to paced respiration ( n = 61 ) reported an average reduction of 1.8 ( 95 % confidence interval [ CI ] 0.9-2 .6 ) hot flushes per day ( -21 % ) compared with 3.0 ( 95 % CI 2.1-3 .8 ) hot flushes per day ( -35 % ) in the music-listening group ( n = 62 ) ( P = .048 ) .
RESULTS	Paced respiration was associated with a 19 % decrease in frequency of moderate-to-severe hot flushes compared with a 44 % decrease with music listening ( P = .02 ) .
CONCLUSIONS	In this randomized trial , women assigned to device-guided slow-paced respiration reported modest improvements in the frequency and severity of their hot flushes , but the paced respiration intervention was significantly less effective than a music-listening intervention in decreasing the frequency and severity of these symptoms .
METHODS	I.

###25675123
OBJECTIVE	This analysis investigates incidence and time course of rash in the EURTAC study .
METHODS	Patients with EGFR mutation-positive non-small-cell lung cancer were randomized 1:1 to receive once daily erlotinib or 3-weekly cycles of chemotherapy .
RESULTS	Of the 86 erlotinib-treated patients , 71 reported rash .
RESULTS	Median time to first rash appearance was 0.7 months .
RESULTS	Most patients ( n = 65 ) had the same or lower grade rash at final assessment compared with initial assessment .
RESULTS	Of the 21 patients with decreased rash grade between initial and final assessments , 61.9 % received no erlotinib dose modification , 42.8 % had no concomitant rash treatment .
CONCLUSIONS	Most rash cases were mild , occurred within 1 month of erlotinib treatment , and rapidly improved without the need for erlotinib dose alterations .

###24637869
BACKGROUND	Gene expression profiling test scores have primarily been used to identify heart transplant recipients who have a low probability of rejection at the time of surveillance testing .
BACKGROUND	We hypothesized that the variability of gene expression profiling test scores within a patient may predict risk of future events of allograft dysfunction or death .
METHODS	Patients from the IMAGE study with rejection surveillance gene expression profiling tests performed at 1 - to 6-month intervals were selected for this cohort study .
METHODS	Gene expression profiling score variability was defined as the standard deviation of an individual 's cumulative test scores .
METHODS	Gene expression profiling ordinal score ( range , 0-39 ) , threshold score ( binary value = 1 if ordinal score 34 ) , and score variability were studied in multivariate Cox regression models to predict future clinical events .
RESULTS	Race , age at time of transplantation , and time posttransplantation were significantly associated with future events in the univariate analysis .
RESULTS	In the multivariate analyses , gene expression profiling score variability , but not ordinal scores or scores over threshold , was independently associated with future clinical events .
RESULTS	The regression coefficient P values were < 0.001 , 0.46 , and 0.773 , for gene expression profiling variability , ordinal , and threshold scores , respectively .
RESULTS	The hazard ratio for a 1 unit increase in variability was 1.76 ( 95 % CI , 1.4-2 .3 ) .
CONCLUSIONS	The variability of a heart recipient 's gene expression profiling test scores over time may provide prognostic utility .
CONCLUSIONS	This information is independent of the probability of acute cellular rejection at the time of testing that is rendered from a single ordinal gene-expression profiling test score .

###25940724
OBJECTIVE	Musculoskeletal symptoms are the most common adverse effects of aromatase inhibitors ( AIs ) and can result in decreased quality of life and discontinuation of therapy .
OBJECTIVE	Omega-3 fatty acids ( O3-FAs ) can be effective in decreasing arthralgia resulting from rheumatologic conditions and reducing serum triglycerides .
METHODS	Women with early-stage breast cancer receiving an AI who had a worst joint pain/stiffness score 5 of 10 using the Brief Pain Inventory-Short Form ( BPI-SF ) were randomly assigned to receive either O3-FAs 3.3 g or placebo ( soybean/corn oil ) daily for 24 weeks .
METHODS	Clinically significant change was defined as 2-point drop from baseline .
METHODS	Patients also completed quality-of-life ( Functional Assessment of Cancer Therapy-Endocrine Symptoms ) and additional pain/stiffness assessments at baseline and weeks 6 , 12 , and 24 .
METHODS	Serial fasting blood was collected for lipid analysis .
RESULTS	Among 262 patients registered , 249 were evaluable , with 122 women in the O3-FA arm and 127 in the placebo arm .
RESULTS	Compared with baseline , the mean observed BPI-SF score decreased by 1.74 points at 12 weeks and 2.22 points at 24 weeks with O3-FAs and by 1.49 and 1.81 points , respectively , with placebo .
RESULTS	In a linear regression adjusting for the baseline score , osteoarthritis , and taxane use , adjusted 12-week BPI-SF scores did not differ by arm ( P = .58 ) .
RESULTS	Triglyceride levels decreased in patients receiving O3-FA treatment and remained the same for those receiving placebo ( P = .01 ) .
RESULTS	No between-group differences were seen for HDL , LDL , or C-reactive protein .
CONCLUSIONS	We found a substantial ( > 50 % ) and sustained improvement in AI arthralgia for both O3-FAs and placebo but found no meaningful difference between the groups .

###25345982
BACKGROUND	Rifamycin SV is under development for treatment of travelers ' diarrhea ( TD ) in a new oral formulation , Rifamycin SV MMX ( RIF-MMX ; Santarus Inc. , San Diego , CA , USA ) , which targets its delivery to the colon , making it a unique rifamycin drug .
METHODS	This was a randomized , double-blind , phase 3 study of adult travelers to Mexico or Guatemala experiencing acute diarrhea .
METHODS	A total of 264 patients received RIF-MMX ( 2200mg twice daily for 3days , n = 199 ) or placebo ( n = 65 ) in a 3:1 ratio .
METHODS	The primary endpoint was the length of time between the administration of first dose of study drug and passage of the last unformed stool ( TLUS ; after which clinical cure was declared ) .
METHODS	Other endpoints included eradication of pathogens from the stools , pathogen minimum inhibitory concentration ( MIC ) , and adverse events ( AEs ) .
RESULTS	TLUS was significantly shorter in the RIF-MMX group ( median : 46.0 hours ) compared with placebo ( median : 68.0 hours ; p = 0.0008 ) and a larger percentage of RIF-MMX treated patients ( 81.4 % ) achieved clinical cure compared with placebo patients ( 56.9 % ) .
RESULTS	TLUS was significantly shorter in the subgroups of patients with enteroaggregative , enterotoxigenic , or diffusely adherent Escherichia coli infections ( p = 0.0035 ) with nonsignificant activity against invasive bacteria ( p = 0.3804 ) .
RESULTS	Overall pathogen eradication rates were numerically higher in the RIF-MMX group ( 67.0 % ) compared with placebo ( 54.8 % ) but the difference did not reach significance ( p = 0.0836 ) .
RESULTS	In vitro resistance to rifamycin SV was observed in some bacteria remaining after treatment of patients with RIF-MMX but was not associated with lower efficacy in them .
RESULTS	AEs appeared to be more frequent with placebo ( 38.5 % ) than with RIF-MMX ( 29.6 % ) .
CONCLUSIONS	RIF-MMX shortened the duration of TD in patients with a broad range of pathogens and was well tolerated .
CONCLUSIONS	The unique pharmacokinetic properties of the drug offer evidence that TD pathogens work at the level of the colon .

###25667135
BACKGROUND	Ethanol celiac plexus neurolysis ( ECPN ) has been shown to be effective in reducing cancer-related pain in patients with locally advanced pancreatic and periampullary adenocarcinoma ( PPA ) .
BACKGROUND	This study examined its efficacy in patients undergoing PPA resection .
METHODS	There were 485 patients who participated in this prospective , randomized , double-blind placebo controlled trial .
METHODS	Patients were stratified by preoperative pain and disease resectability .
METHODS	They received either ECPN ( 50 % ethanol ) or 0.9 % normal saline placebo control .
METHODS	The primary endpoint was short - and long-term pain and secondary endpoints included postoperative morbidity , quality of life , and overall survival .
RESULTS	Data from 467 patients were analyzed .
RESULTS	The primary endpoint , the percentage of PPA patients experiencing a worsening of pain compared with preoperative baseline for resectable patients , was not different between the ethanol and saline groups in either the resectable/pain stratum ( 22 % vs 18 % , relative risk [ RR ] 1.23 [ 0.34 , 4.46 ] ) , or the resectable/no pain stratum ( 37 % vs 34 % , RR 1.10 [ 0.67 , 1.81 ] ) .
RESULTS	In multivariable analysis of resected pancreatic ductal adenocarcinoma ( PDA ) patients , there was a significant reduction in pain in the resectable/pain group , suggesting that surgical resection of the malignancy alone ( independent of ECPN ) decreases pain to a significant degree .
CONCLUSIONS	In this study , we demonstrated a significant reduction in pain after surgical resection of PPA .
CONCLUSIONS	However , the addition of ECPN did not synergize to result in a further reduction in pain , and in fact , its effect may have been masked by surgical resection .
CONCLUSIONS	Given this , we can not recommend the use of ECPN to mitigate cancer-related pain in resectable PPA patients .

###25240493
BACKGROUND	Atrial fibrillation ( AF ) is a risk factor for ischemic stroke and congestive heart failure .
BACKGROUND	AF may cause left atrial ( LA ) dyssynchrony as well as electrical and mechanical remodeling .
BACKGROUND	The aim of this study was to investigate LA dyssynchrony in patients with paroxysmal AF ( PAF ) and its recovery after pulmonary vein isolation ( PVI ) , using a three-dimensional strain method .
METHODS	Thirty patients with PAF who underwent PVI were enrolled .
METHODS	Three-dimensional echocardiography was performed before and 3months after PVI .
METHODS	Twenty subjects in whom AF had never been detected served as controls .
METHODS	LA dyssynchrony was quantified by the standard deviation of time to peak strain ( TP-SD ) from end-diastole by area tracking .
METHODS	Serial changes in TP-SD , LA volume , and global strain in three-dimensional echocardiography were investigated .
RESULTS	In the PAF group , TP-SD was significantly higher ( 9.194.98 % vs 4.802.30 % in controls , P < .02 ) and global strain significantly lower ( 48.220.2 % vs 84.432.9 % in controls , P = .0003 ) than in the control group .
RESULTS	TP-SD , global strain , and LA volume all improved significantly from before to after PVI ( TP-SD , from 9.194.98 % to 6.312.94 % , P = .005 ; global strain , from 48.220.2 % to 58.121.2 % , P = .018 ; LA volume index , 29.510.6 to 25.87.1 mL/m ( 2 ) , P = .04 ) .
RESULTS	Despite the improvement after PVI , TP-SD was still significantly higher and global strain lower than in controls .
CONCLUSIONS	In patients with PAF , impaired LA function was documented by three-dimensional echocardiography .
CONCLUSIONS	Despite early LA structural reverse remodeling , LA dyssynchrony was still observed 3 months after PVI .
CONCLUSIONS	These results may affect medical therapy after successful PVI .

###25217073
OBJECTIVE	To evaluate the relative pain with 3 U.S. Food and Drug Administration-approved bandage soft contact lenses ( SCLs ) applied after photorefractive keratectomy ( PRK ) .
METHODS	Joint Warfighter Refractive Surgery Center , Lackland Air Force Base , Texas , USA .
METHODS	Prospective comparative case series .
METHODS	Patients having PRK were randomized to a senofilcon A ( Acuvue Oasys ) , balafilcon A ( Purevision ) , or lotrafilcon A ( Air Optix ) bandage SCL in each eye postoperatively .
METHODS	Patients were evaluated 1 and 4 days postoperatively and completed a survey rating absolute pain in each eye on a visual analog scale .
RESULTS	The study enrolled 54 patients .
RESULTS	At 1 and 4 days , eyes with the senofilcon A lens had the lowest pain scores followed by eyes with the lotrafilcon A lens and then eyes with the balafilcon A lens .
RESULTS	Averaging qualitative results from 1 and 4 days showed that eyes with the senofilcon A lens were reported as having more pain by 4 % of patients , eyes with the lotrafilcon A lens by 27 % , and eyes with the balafilcon A lens by 53 % ; 16 % reported no difference ( P < .001 ) .
RESULTS	Quantitatively , the senofilcon A lens was 40 % more comfortable than the lotrafilcon A lens and 65 % more comfortable than the balafilcon A lens on average .
RESULTS	The lotrafilcon A lens was 38 % more comfortable than the balafilcon A lens on average ( P < .01 ) .
CONCLUSIONS	There was a statistically and clinically significant difference in post-PRK pain between the 3 bandage SCLs .
CONCLUSIONS	The senofilcon A lens caused the least pain .
BACKGROUND	Dr. Reilly is a consultant to Alcon Laboratories , Inc. and Abbott Medical Optics , Inc. but was not at the time of the study .
BACKGROUND	No other author has a financial or proprietary interest in any material or method mentioned .

###24506318
OBJECTIVE	In an unselected group of women with signs of preterm labour , maintenance tocolysis is not effective in the prevention of preterm birth and does not improve neonatal outcome .
OBJECTIVE	Among women with signs of preterm labour , those who are fetal fibronectin positive have an increased risk of preterm birth .
OBJECTIVE	We investigated whether maintenance tocolysis with nifedipine would delay delivery and improve neonatal outcome in women with threatened preterm labour and a positive fetal fibronectin status .
METHODS	Women with a singleton pregnancy in threatened preterm labour ( 24 ( +0 ) to 33 ( +6 ) weeks ) with a positive fetal fibronectin test were randomised to nifedipine or placebo .
METHODS	Study medication was continued until 36 completed weeks ' gestation .
METHODS	The primary endpoint was prolongation of pregnancy of sevendays .
METHODS	Secondary endpoints were gestational age at delivery and length of NICU admission .
RESULTS	Of the 60 participants , 29 received nifedipine and 31 placebo .
RESULTS	Prolongation of pregnancy by > 7days occurred in 22/29 ( 76 % ) in the nifedipine group and 25/31 ( 81 % ) in the placebo group ( relative risks , RR 0.94 [ 0.72-1 .2 ] ) .
RESULTS	Gestational age at delivery was 36.15.1 weeks for nifedipine and 36.83.6 weeks for placebo ( P = 0.027 ) .
RESULTS	Length of NICU admission [ median ( interquartile ranges , IQR ) ] was 27 ( 24-41 ) days and 16 ( 8-37 ) days in nifedipine and placebo groups , respectively ( P = 0.17 ) .
CONCLUSIONS	In women with threatened preterm labour who are fetal fibronectin positive , maintenance tocolysis with nifedipine does not seem to prolong pregnancy , nor reduce length of NICU admission .

###24884948
BACKGROUND	Randomized placebo-controlled trials represent the gold standard in evaluating healthcare interventions but are rarely performed within orthopedics .
BACKGROUND	Ethical concerns or well-known challenges in recruiting patients for surgical trials in general have been expressed and adding a placebo component only adds to this complexity .
BACKGROUND	The purpose of this study was to report the challenges of recruiting patients into an orthopedic placebo-controlled surgical trial , to determine the number of patients needed to be screened and allocated in order to include one participant into the trial , and to identify reasons associated with participation in a placebo-controlled randomized surgical trial .
METHODS	Data were extracted from an ongoing placebo-controlled randomized controlled trial ( RCT ) on meniscectomy versus placebo surgery .
METHODS	We calculated the number of patients needed to be screened in order to include the required number of participants into the RCT .
METHODS	Participating patients were asked about their rationale for joining the study and which type of information was most useful for deciding upon participation .
RESULTS	A total of 476 patients entered the screening group , of which 190 patients fulfilled the inclusion and exclusion criteria .
RESULTS	102 patients declined to participate in the study due to various reasons and 46 were later excluded ( no meniscus lesion on the magnetic resonance imaging scan or withdrawn consent ) .
RESULTS	A total of 40 patients were finally included in the RCT .
RESULTS	To include one patient into the RCT , 11.9 individuals needed to be screened .
RESULTS	A total of 69 % of participating patients considered the oral information to be the most important and the most common reason for participating was the contribution to research ( 90 % ) .
CONCLUSIONS	Patients are willing to participate in an orthopedic placebo-controlled surgical trial .
CONCLUSIONS	Oral information given by the surgeon to the patient and the contribution to research are important aspects to enhance patient recruitment .
BACKGROUND	ClinicalTrials.gov NCT01264991 , registered 21 December 2010 .

###24725989
OBJECTIVE	The aim of the study was to determine whether low-level laser therapy ( LLLT ) has an analgesic effect in patients with recurrent aphthous stomatitis ( RAS ) .
METHODS	A randomized single-blinded placebo-controlled trial was conducted with LLLT ( wavelength , 809 nm ; power , 60 mW ; pulse frequency , 1800 Hz ; duration , 80 seconds per treatment ; dose , 6.3 J/cm ( 2 ) ) in 40 patients with RAS .
METHODS	The intervention group was treated with LLLT on 3 occasions , with a 1-day interval .
METHODS	The control group was treated similarly , without any laser power .
METHODS	Pain perception ( visual analog scale [ VAS ] rating ) and patients ' experience of eating , drinking , and brushing teeth was registered .
RESULTS	VAS rating decreased ( day 0 until day 2 ) from 84.7 to 31.5 ( LLLT ) and from 81.7 to 76.1 ( placebo ) ( P < .0001 ) .
RESULTS	LLLT also relieved the difficulty of drinking , eating , and brushing teeth .
CONCLUSIONS	LLLT reduced the pain and the inconvenience of eating , drinking , and brushing teeth for patients with RAS , compared with placebo .

###24357575
BACKGROUND	Children in care often have poor outcomes .
BACKGROUND	There is a lack of evaluative research into intervention options .
OBJECTIVE	To examine the efficacy of Multidimensional Treatment Foster Care for Adolescents ( MTFC-A ) compared with usual care for young people at risk in foster care in England .
METHODS	A two-arm single ( assessor ) blinded randomised controlled trial ( RCT ) embedded within an observational quasi-experimental case-control study involving 219 young people aged 11-16 years ( trial registration : ISRCTN 68038570 ) .
METHODS	The primary outcome was the Child Global Assessment Scale ( CGAS ) .
METHODS	Secondary outcomes were ratings of educational attendance , achievement and rate of offending .
RESULTS	The MTFC-A group showed a non-significant improvement in CGAS outcome in both the randomised cohort ( n = 34 , adjusted mean difference 1.3 , 95 % CI -7.1 to 9.7 , P = 0.75 ) and in the trimmed observational cohort ( n = 185 , adjusted mean difference 0.95 , 95 % CI -2.38 to 4.29 , P = 0.57 ) .
RESULTS	No significant effects were seen in secondary outcomes .
RESULTS	There was a possible differential effect of the intervention according to antisocial behaviour .
CONCLUSIONS	There was no evidence that the use of MTFC-A resulted in better outcomes than usual care .
CONCLUSIONS	The intervention may be more beneficial for young people with antisocial behaviour but less beneficial than usual treatment for those without .

###24962473
OBJECTIVE	To study the mutual pharmacokinetic interactions between macitentan , an endothelin receptor antagonist , and sildenafil in healthy male subjects .
METHODS	In this open-label , randomized , three way crossover study , 12 healthy male subjects received the following oral treatments : A ) a loading dose of 30mg macitentan on day 1 followed by 10mg once daily for 3 days , B ) sildenafil 20mg three times a day for 3 days and a single 20mg dose on day 4 and C ) both treatments A and B concomitantly .
METHODS	Plasma concentration-time profiles of macitentan and its active metabolite ACT-132577 ( treatments A and C ) and sildenafil and its N-desmethyl metabolite ( treatments B and C ) were determined on day 4 and analyzed non-compartmentally .
RESULTS	The pharmacokinetics of macitentan were not affected by sildenafil .
RESULTS	In the presence of sildenafil Cmax and AUC of the metabolite ACT-132577 decreased with geometric mean ratios ( 90 % confidence interval ( CI ) ) of 0.82 ( 0.76 , 0.89 ) and 0.85 ( 90 % CI 0.80 , 0.91 ) , respectively .
RESULTS	In the presence of macitentan , plasma concentrations of sildenafil were higher than during treatment with sildenafil alone , resulting in increased Cmax and AUC values .
RESULTS	The respective geometric mean ratios were 1.26 ( 90 % CI 1.07 , 1.48 ) and 1.15 ( 90 % CI 0.94 , 1.41 ) .
RESULTS	The pharmacokinetics of N-desmethylsildenafil were not affected by macitentan .
RESULTS	All treatments were well tolerated .
CONCLUSIONS	A minor , not clinically relevant , pharmacokinetic interaction was observed between macitentan and sildenafil .
CONCLUSIONS	Based on these results , no dose adjustment of either compound appears necessary during concomitant treatment with macitentan and sildenafil .

###26255473
OBJECTIVE	To compare clinical effects of spinal leveraging manipulation and medicine for the treatment of degenerative scoliosis in pain and function .
METHODS	From July 2010 to June 2013 , 38 patients with degenerative scoliosis were randomly divided into spinal leveraging manipulation group and medicine group by coin tossing .
METHODS	In manipulation group , there were 9 males and 11 females aged from 58 to 74 years old with an average of ( 66.637.73 ) , the courses of diseases ranged from 3 to 8 months with an average of ( 5.652.58 ) , spinal leveraging manipulation ( following meridian to straighten tendon , relieving spasm , osteopathy and massage , clearing and activating the channels and collaterals ) were performed for 30 min , once a day , 4 days for a period treatment , totally 9 courses .
METHODS	In medicine group , there were 8 males and 10 females aged from 57 to 70 years old with an average of ( 63.516.61 ) the courses of diseases ranged from 3 to 5 months with an average of ( 4.821.43 ) , celecoxib with eperisone hydrochloride were orally taken , 4 days for a period treatment , totally 9 courses .
METHODS	VAS score , Cobb angle and ODI score were measured .
RESULTS	After treatment , VAS score in manipulation group was ( 5.380.99 ) , ( 6.361.31 ) in medicine group , and had significant meaning ( t = 2.618 , P < 0.05 ) ; there was significant differences in Cobb angle between manipulation group ( 16.514.89 ) and medicine group ( 19.855.03 ) ( t = 2.074 , P < 0.05 ) ; and had obviously meaning in ODI score between manipulation group ( 20.202.93 ) and medicine group ( 26.013.11 ) ( t = 5.592 , P < 0.05 ) .
CONCLUSIONS	Spinal leveraging manipulation for degenerative scoliosis could regulate muscle balance on both side of spine , correct coronal imbalances in spine , recover normal sequence of spine , reduce and remove opperssion and stimulation of nerve root , relieve pain in leg and waist and further improve quality of life .

###25920295
OBJECTIVE	To evaluate the efficacy ofprobiotics , Lactobacillus casei ( Shirvta strain ) , in reducing the incidence ofventilator - associated pneumonia ( VAP ) in medical patients who received mechanical ventilation at Siriraj Hospital .
METHODS	A prospective , randomized , open-label controlled trial was conducted in 150 adult hospitalized patients in medical wards who were expected to receive mechanical ventilation for 72 hours or longer : The patients were randomized to the probiotics group or the control group .
METHODS	All patients received regular care for mechanical ventilation .
METHODS	The patients in the probiotics group received 80 ml of Lactobacillus casei ( Shirota strain ) for oral care after having standard oral care once daily and additional 80 ml of the aforementionedfermented dairy product was given via enteralfeeding once daily .
METHODS	The primary outcomes were incidence of VAP and incidence rate of VAP episodes per 1,000 ventilator-days .
METHODS	The secondary outcomes were length ofhospital stay , mortality at day 28 and 90 , incidence ofdiarrhea , andpresence of resistant bacteria in oropharyngeal and rectal swab samples taken from the patients at baseline , day 7 and day 28 after enrollment .
RESULTS	The baseline characteristics of the patients in the probiotics group ( 75 ) and the control group ( 75 ) were not significantly different .
RESULTS	The patients in the probiotics group were less likely to develop VAP compared with the control group ( 24 % vs. 29.3 % , p = 0.46 ) , respectively .
RESULTS	The incidence rates of VAP in the probiotics and control groups were 22.64 and 30.22 episodes per 1,000 ventilator-days , respectively ( p = 0.37 ) .
RESULTS	A trend of lower prevalence of some resistant bacteria cultured from oropharyngeal swabs in the probiotics group than that in the control group was observed .
RESULTS	Overall 28 - and 90-day mortality and length of hospital stay of the patients in both groups were not significantly different .
CONCLUSIONS	Administration of probiotics containing Lactobacillus casei ( Shirota strain ) has a tendency to reduce the incidence of VAP and colonization with resistant bacteria in oropharyngeal cavity without significant effects on mortality and length of hospital stay .

###26042933
BACKGROUND	Angiogenesis is crucial for glioblastoma growth , and anti-vascular endothelial growth factor agents are widely used in recurrent glioblastoma patients .
BACKGROUND	The number of circulating endothelial cells ( CECs ) is a surrogate marker for endothelial damage .
BACKGROUND	We assessed their kinetics and explored their prognostic value in patients with recurrent glioblastoma .
METHODS	In this side study of the BELOB trial , 141 patients with recurrent glioblastoma were randomised to receive single-agent bevacizumab or lomustine , or bevacizumab plus lomustine .
METHODS	Before treatment , after 4 weeks and after 6 weeks of treatment , CECs were enumerated .
RESULTS	The number of CECs increased during treatment with bevacizumab plus lomustine , but not during treatment in the single-agent arms .
RESULTS	In patients treated with lomustine single agent , higher absolute CEC numbers after 4 weeks ( logCEC hazard ratio ( HR ) 0.41 , 95 % CI 0.18-0 .91 ) and 6 weeks ( logCEC HR 0.16 , 95 % CI 0.05-0 .56 ) of treatment were associated with improved overall survival ( OS ) .
RESULTS	Absolute CEC numbers in patients receiving bevacizumab plus lomustine or bevacizumab single agent were not associated with OS .
CONCLUSIONS	CEC numbers increased during treatment with bevacizumab plus lomustine but not during treatment with either agent alone , suggesting that this combination induced the greatest vascular damage .
CONCLUSIONS	Although the absolute number of CECs was not associated with OS in patients treated with bevacizumab either alone or in combination , they could serve as a marker in glioblastoma patients receiving lomustine single agent .

###24588860
BACKGROUND	Patients with traumatic knee complaints regularly consult their general practitioner ( GP ) .
BACKGROUND	MRI might be a valuable diagnostic tool to assist GPs in making appropriate treatment decisions and reducing costs .
BACKGROUND	Therefore , this study will assess the cost-effectiveness of referral to MRI by GPs compared with usual care , in patients with persistent traumatic knee complaints .
METHODS	This is a multi-centre , open-labelled randomised controlled non-inferiority trial in combination with a concurrent observational cohort study .
METHODS	Eligible patients ( aged 18-45 years ) have knee complaints due to trauma ( or sudden onset ) occurring in the preceding 6 months and consulting their GP .
METHODS	Participants are randomised to : 1 ) an MRI group , i.e. GP referral to MRI , or 2 ) a usual care group , i.e. no MRI .
METHODS	Primary outcomes are knee-related daily function , medical costs ( healthcare use and productivity loss ) , and quality of life .
METHODS	Secondary outcomes are disability due to knee complaints , severity of knee pain , and patients ' perceived recovery and satisfaction .
METHODS	Outcomes are measured at baseline and at 1.5 , 3 , 6 , 9 and 12 months follow-up .
METHODS	Also collected are data on patient demographics , GPs ' initial working diagnosis , GPs ' preferred management at baseline , and MRI findings .
CONCLUSIONS	In the Netherlands , the additional diagnostic value and cost-effectiveness of direct access to knee MRI for patients presenting with traumatic knee complaints in general practice is unknown .
CONCLUSIONS	Although GPs increasingly refer patients to MRI , the Dutch clinical guideline ` Traumatic knee complaints ' for GPs does not recommend referral to MRI , mainly because the cost-effectiveness is still unknown .
BACKGROUND	Dutch Trial Registration : NTR3689 .

###24991714
BACKGROUND	Cervical spondylotic myelopathy ( CSM ) is the most common cause of spinal cord dysfunction in the world .
BACKGROUND	There are significant practice variation and uncertainty as to the optimal surgical approach for treating CSM .
OBJECTIVE	To determine whether ventral surgery is associated with superior Short Form-36 Physical Component Summary outcome at the 1-year follow-up compared with dorsal ( laminectomy/fusion or laminoplasty ) surgery for the treatment of CSM , to investigate whether postoperative sagittal balance is an independent predictor of overall outcome , and to compare health resource use for ventral and dorsal procedures .
METHODS	The study is a randomized , controlled trial with a nonrandomized arm for patients who are eligible but decline randomization .
METHODS	Two hundred fifty patients ( 159 randomized ) with CSM from 11 sites will be recruited over 18 months .
METHODS	The primary outcome is the Short Form-36 Physical Component Summary score .
METHODS	Secondary outcomes include disease-specific outcomes , overall health-related quality of life ( EuroQOL 5-dimension questionnaire ) , and health resource use .
OBJECTIVE	This will be the first randomized , controlled trial to compare directly the health-related quality-of-life outcomes for ventral vs dorsal surgery for treating CSM .
CONCLUSIONS	A National Institutes of Health-funded ( 1R13AR065834-01 ) investigator meeting was held before the initiation of the trial to bring multiple stakeholders together to finalize the study protocol .
CONCLUSIONS	Study investigators , coordinators , and major stakeholders were able to attend and discuss strengths of , limitations of , and concerns about the study .
CONCLUSIONS	The final protocol was approved for funding by the Patient-Centered Outcomes Research Institute ( CE-1304-6173 ) .
CONCLUSIONS	The trial began enrollment on April 1 , 2014 .

###24457536
OBJECTIVE	Silicone excipients are commonly used ingredients because of their emollient and skin-conditioning effects , and their ability to form uniform , water-resistant , yet permeable films .
OBJECTIVE	Based on comparisons with organic materials and conflicting knowledge from silicones used in scar treatment , the misconception still exists that silicone topical excipients are occlusive substances that may block the passive loss of water through the upper skin layers .
OBJECTIVE	Therefore , 3 types of common silicone excipients and 3 water-in - ( oil-plus-silicone ) or W / ( O + Si ) creams , containing 10 % ( w/w ) of the respective silicones , were investigated as a function of time and compared to petrolatum .
METHODS	Transepidermal water loss ( TEWL ) and skin hydration measurements were carried out after a single topical application on forearm skin of 26 healthy young female volunteers .
RESULTS	Both petrolatum and silicones significantly decreased TEWL 15 min after application , but the measurements for the silicones were not significantly different from the untreated control values .
RESULTS	The tested silicones did not moisturize the skin .
RESULTS	Petrolatum formed an occlusive layer , creating an increase in skin hydration for more than 4 h.
RESULTS	The results measured for the W / ( O + Si ) creams indicated that they moisturized the skin , without any effect on TEWL .
CONCLUSIONS	A clear difference was shown between the skin occlusive properties of petrolatum and the water vapor permeability of the common silicone excipient materials .

###25005172
OBJECTIVE	The aim of this study is to evaluate the effectiveness of life review ( LR ) based on specific positive events in non-depressed older adults taking part in an active aging program .
METHODS	Fifty-five older adults were randomly assigned to an experimental group or an active control ( AC ) group .
METHODS	A six-session individual training of LR based on specific positive events was carried out with the experimental group .
METHODS	The AC group undertook a `` media workshop '' of six sessions focused on learning journalistic techniques .
METHODS	Pre-test and post-test measures included life satisfaction , depressive symptoms , experiencing the environment as rewarding , and autobiographical memory ( AM ) scales .
RESULTS	LR intervention decreased depressive symptomatology , improved life satisfaction , and increased specific memories .
CONCLUSIONS	The findings suggest that practice in AM for specific events is an effective component of LR that could be a useful tool in enhancing emotional well-being in active aging programs , thus reducing depressive symptoms .

###24560453
BACKGROUND	Although colonoscopy is the accepted standard for detection of colorectal adenomas and cancers , many adenomas and some cancers are missed .
BACKGROUND	To avoid interval colorectal cancer , the adenoma miss rate of colonoscopy needs to be reduced by improvement of colonoscopy technique and imaging capability .
BACKGROUND	We aimed to compare the adenoma miss rates of full-spectrum endoscopy colonoscopy with those of standard forward-viewing colonoscopy .
METHODS	We did an international , multicentre , randomised trial at three sites in Israel , one site in the Netherlands , and two sites in the USA between Feb 1 , 2012 , and March 31 , 2013 .
METHODS	Patients aged 18-70 years referred for colorectal cancer screening , polyp surveillance , or diagnostic assessment underwent same-day , back-to-back tandem colonoscopy with standard forward-viewing colonoscope and the full-spectrum endoscopy colonoscope .
METHODS	The patients were randomly assigned ( 1:1 ) , via computer-generated randomisation with block size of 20 , to which procedure was done first .
METHODS	The endoscopist was masked to group allocation until immediately before the start of colonoscopy examinations ; patients were not masked .
METHODS	The primary endpoint was adenoma miss rates .
METHODS	We did per-protocol analyses .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01549535 .
RESULTS	197 participants were enrolled .
RESULTS	185 participants were included in the per-protocol analyses : 88 ( 48 % ) were randomly assigned to receive standard forward-viewing colonoscopy first , and 97 ( 52 % ) to receive full-spectrum endoscopy colonoscopy first .
RESULTS	By per-lesion analysis , the adenoma miss rate was significantly lower in patients in the full-spectrum endoscopy group than in those in the standard forward-viewing procedure group : five ( 7 % ) of 67 vs 20 ( 41 % ) of 49 adenomas were missed ( p < 00001 ) .
RESULTS	Standard forward-viewing colonoscopy missed 20 adenomas in 15 patients ; of those , three ( 15 % ) were advanced adenomas .
RESULTS	Full-spectrum endoscopy missed five adenomas in five patients in whom an adenoma had already been detected with first-pass standard forward-viewing colonoscopy ; none of these missed adenomas were advanced .
RESULTS	One patient was admitted to hospital for colitis detected at colonoscopy , whereas five minor adverse events were reported including vomiting , diarrhoea , cystitis , gastroenteritis , and bleeding .
CONCLUSIONS	Full-spectrum endoscopy represents a technology advancement for colonoscopy and could improve the efficacy of colorectal cancer screening and surveillance .
BACKGROUND	EndoChoice .

###25168098
BACKGROUND	Patients with previous coronary artery bypass grafting ( CABG ) who underwent percutaneous coronary intervention ( PCI ) have an increased repeat revascularization rate , but data on contemporary second-generation drug-eluting stents ( DES ) are scarce .
METHODS	We evaluated 1-year clinical outcome following secondary revascularization by PCI in patients of the TWENTE trial and non-enrolled TWENTE registry , and compared patients with previous CABG versus patients without previous CABG .
RESULTS	Of all 1709 consecutive patients , 202 ( 11.8 % ) had previously undergone CABG ( on average 11.28.5 years ago ) .
RESULTS	CABG patients were older ( 68.59.4 years vs. 64.110.7 years , P < 0.001 ) and more often had diabetes ( 28.7 % vs. 20.9 % , P = 0.01 ) and previous PCI ( 40.1 % vs. 19.8 % , P < 0.001 ) compared to patients without previous CABG .
RESULTS	Nevertheless , a higher target vessel revascularization ( TVR ) rate following PCI in the CABG patients ( 9.4 % vs. 2.3 % , P < 0.001 ) was the only significant difference in clinical outcome at 1-year follow-up ( available for 99.6 % ) .
RESULTS	Among CABG patients , the TVR rate was significantly higher in patients treated for graft lesions ( n = 65 ; 95.4 % in vein grafts ) than in patients treated for native coronary lesions only ( n = 137 ) ( 18.5 % vs. 5.1 % , P = 0.002 ) .
RESULTS	Among 1638 patients with PCI of native coronary lesions only , there was only a non-significant difference in TVR between patients with previous CABG versus patients without previous CABG ( 5.1 % vs. 2.3 % , P = 0.08 ) .
CONCLUSIONS	Patients with previous CABG showed a favorable safety profile after PCI with second-generation DES .
CONCLUSIONS	Nevertheless , their TVR rate was still much higher , driven by more repeat revascularizations after PCI of degenerated vein grafts .
CONCLUSIONS	In native coronary lesions , there was no such difference .

###25625366
OBJECTIVE	The aim of this study was to compare endothelial cell loss and graft success 6 months after endothelial keratoplasty ( EK ) with paired donor corneas stored in Optisol GS and Life4C solutions and their associated storage chambers .
METHODS	Donor pairs were stored , one in Optisol GS and the other in Life4C , and prepared for Descemet stripping automated EK or Descemet membrane EK .
METHODS	Matched pairs of recipients with Fuchs dystrophy were randomized to 1 member of each donor pair .
METHODS	Clarity of recipient stroma , intraocular pressure , and complications were followed for 6 months .
METHODS	Central endothelial images of the donor cornea at screening and 3 and 6 months after EK were analyzed by a masked central reading center .
METHODS	Dual grading of endothelial cell density was performed using the center method .
METHODS	Differences in endothelial cell density and cell loss were examined by paired analysis .
RESULTS	Thirty-two pairs were enrolled , and 27 were analyzed ( 5 had improper matching or loss to follow-up ) .
RESULTS	Donor age was 59 14 years , median death-to-surgery time was 4 days ( range , 2-9 days ) , 6 recipient pairs had Descemet membrane EK , and 21 had Descemet stripping automated EK .
RESULTS	Recipient age was comparable in the Optisol GS and Life4C groups ( 70 vs. 68 years , respectively , P = 0.46 ) .
RESULTS	Six-month central endothelial cell loss did not differ significantly between the Life4C and Optisol GS groups ( 18 18 % vs. 20 20 % , respectively , P = 0.55 ) .
RESULTS	All recipient corneas were clear at 6 months in both groups .
CONCLUSIONS	Endothelial cell loss and graft success were comparable at 6 months for paired donor corneas stored in Optisol GS and Life4C.Clinical Trial Registration-URL : http://www.clinicaltrials.gov .
CONCLUSIONS	Unique identifier : NCT01657500 .

###24270291
OBJECTIVE	To evaluate the process of implementation of a social and physical environmental intervention and to explore differences regarding this process between both interventions .
METHODS	Context , recruitment , dose delivered , fidelity , reach , dose received , satisfaction , and implementation barriers were investigated .
RESULTS	Reach for the social and physical environmental interventions ranged from 45 % to 76 % .
RESULTS	Mean satisfaction for the social environmental intervention was 6.0 and for the physical environmental intervention was 7.0 .
RESULTS	Generally , the results were higher for team leaders than for employees .
RESULTS	Furthermore , the implementation of the physical intervention was better at the departments that additionally received the social intervention .
CONCLUSIONS	Both interventions were better implemented on the level of the team leader than that of the employees .
CONCLUSIONS	Furthermore , the combined interventions received higher evaluation scores .
CONCLUSIONS	To increase satisfaction and participation , attention should be paid to both employees and team leaders during implementation .

###24961881
OBJECTIVE	We aimed to identify salutogenic patterns of parental knowledge , behaviors , attitudes , and beliefs that may support resistance to early childhood caries ( ECC ) among a high caries population of preschool American Indian ( AI ) children .
METHODS	Participants were 981 child-parent dyads living on a Southwestern reservation who completed baseline assessments for an ongoing randomized clinical trial .
METHODS	T-tests were used to assess differences between reported knowledge , behaviors , and beliefs of parents whose children were caries-free ( 10.7 percent ) and those whose children had caries ( 89.3 percent ) .
METHODS	Chi-square analyses were used for categorical variables .
RESULTS	Although there were no socio-demographic differences , parents of caries-free children viewed oral health as more important and reported more oral health knowledge and adherence to caries-preventing behaviors for their children .
RESULTS	Parents of caries-free children were more likely to have higher internal locus of control , to perceive their children as less susceptible to caries , and to perceive fewer barriers to prevention .
RESULTS	These parents also had higher sense of coherence scores and reported lower levels of personal distress and community-related stress .
CONCLUSIONS	Effective interventions for ECC prevention in high-caries AI populations may benefit from approaches that support and model naturally salutogenic behaviors .

###24906581
OBJECTIVE	Physical activity has a positive effect on people 's mental health and well-being .
OBJECTIVE	The aim of this study was to compare the effects of hatha yoga and resistance exercises on mental health and well-being in sedentary adults .
METHODS	Randomized controlled study .
METHODS	Fifty-one participants aged mean ( SD ) 25.6 ( 5.7 ) years were randomly divided into three groups : Hatha Yoga Group , Resistance Exercise Group and Control Group .
METHODS	The Hatha Yoga Group and Resistance Exercise Group participated in sessions three days per week for 7 weeks and the Control Group did not participate in any sessions .
METHODS	All the subjects were evaluated through the Rosenberg Self-Esteem Scale , Beck Depression Inventory , Body Cathexis Scale , Nottingham Health Profile and Visual Analog Scale for fatigue pre-and post-session .
RESULTS	Significant improvements were found in terms of all outcome measures in the Hatha Yoga Group and the resistance exercise group .
RESULTS	No improvements were found in the Control Group .
RESULTS	Hatha yoga more improved the dimensions fatigue , self-esteem , and quality of life , whilst resistance exercise training more improved body image .
RESULTS	Hatha yoga and resistance exercise decreased depression symptoms at a similar level .
CONCLUSIONS	The results indicated that hatha yoga and resistance exercise had positive effects on mental health and well-being in sedentary adults .
CONCLUSIONS	Hatha yoga and resistance exercise may affect different aspects of mental health and well-being .

###24509716
BACKGROUND	Molecular imaging using positron emission tomography/computerized tomography ( PET/CT ) may add relevant incremental diagnostic information to standard structural cross-sectional imaging .
BACKGROUND	Such information may allow identification of patients with rectal cancer that are more likely to develop complete tumor regression after neoadjuvant chemoradiation therapy ( CRT ) .
BACKGROUND	The objective of this report was to identify PET/CT features that are associated with a complete response after CRT .
METHODS	99 cT2-4N0-2M0 distal rectal cancer patients ( 7 cm from anal verge ) were included in this prospective single center trial ( NCT 00254683 ) .
METHODS	Patients underwent baseline PET/CT followed by 54 Gy and 5-fluorouracil-based neoadjuvant CRT .
METHODS	After completion of therapy , patients underwent 6 - and 12-week PET/CT .
METHODS	Clinical assessment of tumor response was performed at 12 weeks and was blinded to radiological information .
METHODS	Patients were treated according to clinical assessment .
RESULTS	There were seven patients with a complete pathological response ( pCR ) and 16 with a complete clinical response ( cCR ) ( 23 complete responders ) .
RESULTS	Comparison of pCR exclusively and non-pCR revealed that only baseline primary tumor standard uptake value ( SUV ) was a significant predictor of response .
RESULTS	Comparison of complete responders ( pCR or cCR ) and non-complete responders showed that depth of rectal wall uptake at baseline PET/CT ( p = 0.002 ) and variation between baseline and 12-week maximum standard uptake value ( SUVmax ) of primary tumor ( p = 0.001 ) were independent predictors for complete response at multivariate analysis .
RESULTS	A decrease > 67 % between baseline and 6-week or 76 % between baseline and 12-week SUVmax were associated with complete response ( pCR or cCR ; p = 0.02 and p < 0.001 , respectively ) .
CONCLUSIONS	Positron emission tomography/computerized tomography at baseline , 6 and 12 weeks , may provide information regarding patients with a higher likelihood of developing complete tumor regression following neoadjuvant CRT .

###24636695
BACKGROUND	Acupuncture is often used for primary dysmenorrhea .
BACKGROUND	But there is no convincing evidence due to low methodological quality .
BACKGROUND	We aim to assess immediate effect of acupuncture at specific acupoint compared with unrelated acupoint and nonacupoint on primary dysmenorrhea .
METHODS	The Acupuncture Analgesia Effect in Primary Dysmenorrhoea-II is a multicenter controlled trial conducted in six large hospitals of China .
METHODS	Patients who met inclusion criteria were randomly assigned to classic acupoint ( N = 167 ) , unrelated acupoint ( N = 167 ) , or non-acupoint ( N = 167 ) group on a 1:1:1 basis .
METHODS	They received three sessions with electro-acupuncture at a classic acupoint ( Sanyinjiao , SP6 ) , or an unrelated acupoint ( Xuanzhong , GB39 ) , or nonacupoint location , respectively .
METHODS	The primary outcome was subjective pain as measured by a 100-mm visual analog scale ( VAS ) .
METHODS	Measurements were obtained at 0 , 5 , 10 , 30 , and 60 minutes following the first intervention .
METHODS	In addition , patients scored changes of general complaints using Cox retrospective symptom scales ( RSS-Cox ) and 7-point verbal rating scale ( VRS ) during three menstrual cycles .
METHODS	Secondary outcomes included VAS score for average pain , pain total time , additional in-bed time , and proportion of participants using analgesics during three menstrual cycles .
RESULTS	Five hundred and one people underwent random assignment .
RESULTS	The primary comparison of VAS scores following the first intervention demonstrated that classic acupoint group was more effective both than unrelated acupoint ( -4.0 mm , 95 % CI -7.1 to -0.9 , P = 0.010 ) and nonacupoint ( -4.0 mm , 95 % CI -7.0 to -0.9 , P = 0.012 ) groups .
RESULTS	However , no significant differences were detected among the three acupuncture groups for RSS-Cox or VRS outcomes .
RESULTS	The per-protocol analysis showed similar pattern .
RESULTS	No serious adverse events were noted .
CONCLUSIONS	Specific acupoint acupuncture produced a statistically , but not clinically , significant effect compared with unrelated acupoint and nonacupoint acupuncture in primary dysmenorrhea patients .
CONCLUSIONS	Future studies should focus on effects of multiple points acupuncture on primary dysmenorrhea .

###25742559
BACKGROUND	There is an increased demand for the reduction of localized adipose tissue by noninvasive methods .
OBJECTIVE	The objective of this study was to determine the safety and efficacy of noninvasive lipolysis of excess adiposities overlying the lateral thigh region using acoustic wave therapy ( AWT ) .
OBJECTIVE	This study incorporates 2 mechanical waves with varying properties in the same session : radial and planar AWT .
METHODS	The treatment was performed using AWT on the lateral thigh areas of 15 female patients .
METHODS	The study was performed using the planar and radial pulse handpieces , with 8 sessions performed within 4 weeks .
METHODS	Follow-up visits were performed 1 , 4 , and 12 weeks after the last treatment .
RESULTS	Reduction in both thigh circumference and subcutaneous fat layer thickness , measured through ultrasound , was observed .
CONCLUSIONS	This study demonstrates that AWT is safe and efficacious for the treatment of localized adiposities in the saddlebag area .
CONCLUSIONS	However , the results obtained were not statistically significant .
CONCLUSIONS	Larger studies will be needed to further access the effects of AWT on thigh circumference reduction .
CONCLUSIONS	Furthermore , the authors also found an improvement in the appearance of both cellulite and skin firmness after the treatments .

###25740026
BACKGROUND	Periarticular injection is becoming more commonly utilized for pain relief following total knee arthroplasty .
BACKGROUND	However , we are aware of no randomized controlled trial that has investigated the efficacy of periarticular injection for pain relief after simultaneous bilateral total knee arthroplasty .
METHODS	We performed a randomized controlled trial of patients scheduled for simultaneous bilateral total knee arthroplasty .
METHODS	Seventy-one patients with 142 involved knees were randomly assigned to receive periarticular injection or epidural analgesia .
METHODS	Other perioperative interventions , including spinal anesthesia , surgical techniques , and postoperative medication protocols , were identical for all patients .
METHODS	The primary outcome was postoperative pain at rest , measured with the use of a 100-mm visual analog scale ( VAS ) during the initial twenty-four-hour postoperative period .
METHODS	The cumulative VAS score was calculated with use of the area under the curve and compared between the groups .
RESULTS	Postoperative pain at rest , quantified as the area under the curve of serial assessments during the initial twenty-four-hour postoperative period , was significantly less in the periarticular injection group than in the epidural analgesia group ( 174.9 181.5 mm day compared with 360.4 360.6 mm day ; p = 0.0073 ) .
RESULTS	The prevalences of nausea on the night of surgery and postoperative day 1 and of pruritus were significantly lower in the periarticular injection group than in the epidural analgesia group ( 14 % and 45 % , p = 0.0031 ; 14 % and 55 % , p = 0.0003 ; and 0 % and 15 % , p = 0.014 , respectively ) .
CONCLUSIONS	Periarticular injection was associated with better pain relief during the first twenty-four hours following simultaneous bilateral total knee arthroplasty and decreased opioid-related side effects compared with epidural analgesia .
CONCLUSIONS	Periarticular injection may be preferable to epidural analgesia for pain relief after simultaneous bilateral total knee arthroplasty .

###24452659
BACKGROUND	Management of low back pain after spinal surgeries is one of the most challenging problems in pain medicine .
BACKGROUND	Transforaminal lumbar epidural steroid injection has been used with inconsistent response .
BACKGROUND	Most patients require multiple and frequent injections due to high recurrence of back pain .
OBJECTIVE	To find out whether the addition of hyaluronidase to the epidural injectate affects the quality and duration of analgesia in patients with low back pain secondary to failed back surgery syndrome .
METHODS	Prospective randomized trial .
METHODS	The study was registered in the Government Clinical Trial registry and the protocol was reviewed and approved by the institutional review board .
METHODS	After obtaining an informed consent , 25 patients with low back pain due to failed back syndrome were randomly assigned to receive a transforaminal epidural injection of hyaluronidase 1500 IU ( HYL ) or normal saline ( NSL ) to a mixture of bupivacaine 0.5 % ( 1 mL ) and triamcinolone 40 mg ( 1 mL ) in a double-blind fashion .
METHODS	An interventional pain specialist using fluoroscopic guidance performed all epidural injections .
METHODS	The patients received a comprehensive neurological examination by a non-interventional pain specialist who was blinded to the treatment during their follow-up visits , scheduled one , 2 , and 4 weeks after the intervention .
METHODS	Numerical pain scores , analgesic requirement , and satisfaction scores were recorded during every visit .
RESULTS	There was no difference in demographic data between the 2 groups .
RESULTS	Pain scores and total analgesic requirement were significantly lower in the HYL group at 2 and 4 weeks after blockade ( P < 0.01 ) .
RESULTS	Patient satisfaction was higher in the HYL group .
CONCLUSIONS	The study was limited by a relatively small sample size .
CONCLUSIONS	We conclude that adding hyaluronidase to the epidural injectate was effective in the management of chronic low back pain in patients with failed back surgery syndrome demonstrated over a period of 4 weeks .

###24566987
BACKGROUND	Creating the visual illusion of touch can improve tactile perception in healthy subjects .
OBJECTIVE	We were interested in seeing if creating the illusion of touch in an insensate area could improve sensation in that area .
METHODS	Fourteen people with chronic numbness participated in a randomized crossover experiment .
METHODS	The 4 conditions were the following : ( a ) stimulation over the unaffected limb with mirror visual feedback ( experimental condition ) , ( b ) stimulation over the affected limb with mirror visual feedback , ( c ) stimulation over the unaffected limb without mirror visual feedback , and ( d ) stimulation over the affected limb without mirror visual feedback .
METHODS	Participants were assessed before and after each condition using the Ten-Test and mechanical detection thresholds .
METHODS	Data were analyzed using linear mixed models .
RESULTS	Only the experimental condition produced a change in the Ten-Test ( mean difference = -1.1 ; 95 % confidence interval = -1.8 to -0.4 ; P = .003 ) , corresponding to a 24 % improvement in sensation .
RESULTS	No differences were observed for any condition in mechanical detection thresholds .
CONCLUSIONS	Creating the illusion of touch may improve sensory function in areas of chronic numbness .
CONCLUSIONS	This preliminary finding adds to the growing body of evidence supporting the use of techniques that directly target cortical function in people with peripheral nerve injury .

###24439348
BACKGROUND	A number of studies have described influenza vaccination coverage during pregnancy but few publications have described rates of other vaccinations .
OBJECTIVE	To describe vaccination rates during pregnancy in the Vaccine Safety Datalink ( VSD ) , with particular focus on vaccinations contraindicated during pregnancy .
METHODS	Pregnancies ending in 2002 through 2009 and vaccinations administered during these pregnancies were identified in the VSD .
METHODS	Vaccination rates per 1000 pregnancies during the study period were calculated by vaccine type , recommendation category , pregnancy year , maternal age , and trimester .
METHODS	Analyses were conducted in 2012-2013 .
RESULTS	In the VSD , 669,695 pregnancies and 141,389 vaccinations were identified .
RESULTS	Trivalent inactivated influenza ( TIV ) was the most commonly administered vaccination ( 174.1 doses per 1000 pregnancies ) and was most often administered during the 2nd and 3rd trimesters .
RESULTS	The most common vaccines in the `` consider if indicated '' category were tetanus-diphtheria ( 6.1 per 1000 ) and hepatitis B ( 3.7 per 1000 ) .
RESULTS	Contraindicated vaccination was infrequent , and the majority of these were measles-mumps-rubella ( MMR ) ( 1.2 per 1000 ) ; varicella ( 1.0 per 1000 ) ; and live-attenuated influenza vaccine ( LAIV ) ( 0.3 per 1000 ) .
RESULTS	Both `` consider if indicated '' and contraindicated vaccines were more frequently administered during early pregnancy .
CONCLUSIONS	TIV was the most commonly administered vaccine .
CONCLUSIONS	With the exception of TIV , other vaccines were most frequently administered during early pregnancy and among younger women , suggesting that vaccination may occur when the woman and/or provider are unaware of the pregnancy .
CONCLUSIONS	Contraindicated vaccines were infrequently administered during pregnancy ; however , given that some women received contraindicated vaccines later in pregnancy , clearer recommendations and improved provider education may be needed .

###25142196
OBJECTIVE	Antidepressant medication ( ADM ) is efficacious in the treatment of depression , but not all patients achieve remission and fewer still achieve recovery with ADM alone .
OBJECTIVE	To determine the effects of combining cognitive therapy ( CT ) with ADM vs ADM alone on remission and recovery in major depressive disorder ( MDD ) .
METHODS	A total of 452 adult outpatients with chronic or recurrent MDD participated in a trial conducted in research clinics at 3 university medical centers in the United States .
METHODS	The patients were randomly assigned to ADM treatment alone or CT combined with ADM treatment .
METHODS	Treatment was continued for up to 42 months until recovery was achieved .
METHODS	Antidepressant medication with or without CT. .
METHODS	Blind evaluations of recovery with a modified version of the 17-item Hamilton Rating Scale for Depression and the Longitudinal Interval Follow-up Evaluation .
RESULTS	Combined treatment enhanced the rate of recovery vs treatment with ADM alone ( 72.6 % vs 62.5 % ; t451 = 2.45 ; P = .01 ; hazard ratio [ HR ] , 1.33 ; 95 % CI , 1.06-1 .68 ; number needed to treat [ NNT ] , 10 ; 95 % CI , 5-72 ) .
RESULTS	This effect was conditioned on interactions with severity ( t451 = 1.97 ; P = .05 ; NNT ,5 ) and chronicity ( 2 = 7.46 ; P = .02 ; NNT ,6 ) such that the advantage for combined treatment was limited to patients with severe , nonchronic MDD ( 81.3 % vs 51.7 % ; n = 146 ; t145 = 3.96 ; P = .001 ; HR , 2.34 ; 95 % CI , 1.54-3 .57 ; NNT , 3 ; 95 % CI , 2-5 ) .
RESULTS	Fewer patients dropped out of combined treatment vs ADM treatment alone ( 18.9 % vs 26.8 % ; t451 = -2.04 ; P = .04 ; HR , 0.66 ; 95 % CI , 0.45-0 .98 ) .
RESULTS	Remission rates did not differ significantly either as a main effect of treatment or as an interaction with severity or chronicity .
RESULTS	Patients with comorbid Axis II disorders took longer to recover than did patients without comorbid Axis II disorders regardless of the condition ( P = .01 ) .
RESULTS	Patients who received combined treatment reported fewer serious adverse events than did patients who received ADMs alone ( 49 vs 71 ; P = .02 ) , largely because they experienced less time in an MDD episode .
CONCLUSIONS	Cognitive therapy combined with ADM treatment enhances the rates of recovery from MDD relative to ADMs alone , with the effect limited to patients with severe , nonchronic depression .
BACKGROUND	clinicaltrials.gov Identifier : NCT00057577 .

###25460343
BACKGROUND	Home-based rehabilitation following total knee replacement surgery can be as effective as clinic-based or in-patient rehabilitation .
BACKGROUND	The use of the Nintendo Wii has been postulated as a novel rehabilitation tool that adds an additional focus on balance and proprioception into the recovery protocol .
BACKGROUND	The aim of the proposed clinical trial is to investigate the effectiveness of this novel rehabilitation tool , used at home for three months after total knee replacement surgery and to assess any lasting improvements in functional outcome at one year .
METHODS	This will be a randomised controlled trial of 128 patients undergoing primary total knee replacement .
METHODS	The participants will be recruited preoperatively from three surgeons at a single centre .
METHODS	There will be no change to the usual care provided until 6 weeks after the operation .
METHODS	Then participants will be randomised to either the Wii-Fit group or usual rehabilitative care group .
METHODS	Outcomes will be assessed preoperatively , a 6-week post surgery baseline and then at 18 weeks , 6 months and 1 year .
METHODS	The primary outcome is the change in self-reported WOMAC total score from week 6 to 18 weeks .
METHODS	Secondary outcomes include objective measures of strength , function and satisfaction scores .
CONCLUSIONS	The results of this clinical trial will be directly relevant for implementation into clinical practice .
CONCLUSIONS	If beneficial , this affordable technology could be used by many patients to rehabilitate at home .
CONCLUSIONS	Not only could it optimize the outcomes from their total knee replacement surgery but decrease the need for clinic-based or outpatient therapy for the majority .
BACKGROUND	( ACTRN12611000291987 ) .

###24473387
OBJECTIVE	To observe the changes of plasminogen activator inhibitor-1 and D-dimer during continuous blood purification ( CBP ) and related factors .
METHODS	Sixteen patients who were diagnosed with multiple organ dysfunction syndrome ( MODS ) were randomly divided into 2 groups : 8 patients received standard continuous blood purification with heparin anticoagulation , and the other 8 received CBP without anticoagulation .
METHODS	Ten normal blood samples were collected from healthy volunteers as controls .
METHODS	All patients underwent CBP for 8 h. Blood was taken from those patients at 0 , 15 , 60 , 120 and 480 min during the CBP .
METHODS	Plasma plasminogen activator inhibitor-1 , D-dimer and serum TNF - and IL-1 were measured by ELISA .
RESULTS	Plasma levels of PAI-1 and D-dimer were increased significantly compared with those in the control group ( P < 0.05 ) .
RESULTS	Plasma level of PAI-1 was reduced ( P < 0.05 ) and D-dimer was increased ( P < 0.05 ) after the CBP .
RESULTS	The level of plasma PAI-1 in the heparin group was significant reduced compared with the group of CBP without anticoagulation ( P < 0.05 ) .
RESULTS	There was negative correlation between the level of PAI-1 and the dosage of heparin used during a CBP session in the heparin group ( r = -0.746 , P < 0.001 ) .
CONCLUSIONS	The level of PAI-1 and D-dimer is higher in patients with MODS than that in the normal controls .
CONCLUSIONS	After the CBP treatment , there is significant decrease in PAI-1 and increase in D-dimer in both groups .
CONCLUSIONS	Heparin used during CBP can reduce PAI-1 which intensifies its function of anticoagulation .

###25262270
BACKGROUND	In the TRACER trial , vorapaxar , a protease-activated receptor-1 antagonist , plus standard care in non-ST-segment elevation acute coronary syndrome ( NSTE ACS ) patients did not significantly reduce the primary composite end point but reduced a key secondary end point and significantly increased bleeding .
BACKGROUND	History of peripheral artery disease ( PAD ) was a risk-enrichment inclusion criterion .
BACKGROUND	We investigated the efficacy and safety of vorapaxar in NSTE ACS patients with documented PAD .
METHODS	TRACER was a double-blind , randomized trial comparing vorapaxar with placebo in 12,944 patients with NSTE ACS .
RESULTS	In total , 936 ( 7.2 % ) patients had a history of PAD .
RESULTS	Ischemic events occurred more frequently among patients with PAD ( 25.3 % ) versus no PAD ( 12.2 % , P < .001 ) , and Global Use of Strategies to Open Occluded Coronary Arteries moderate/severe bleeding was more common in PAD ( 9.1 % ) versus no PAD ( 5.0 % , P = .004 ) .
RESULTS	Similar rates of the composite end point ( cardiovascular death , myocardial infarction , or stroke ) occurred in patients with PAD treated with vorapaxar and placebo ( 21.7 % vs 24.8 % , P interaction = .787 ) .
RESULTS	Patients with PAD treated with vorapaxar , when compared with placebo , also had a numerical reduction in peripheral revascularization procedures ( 8.1 % vs 9.0 % , P = .158 ) and a lower extremity amputation rate ( 0.9 % vs 1.5 % , P = .107 ) .
RESULTS	Vorapaxar increased Global Use of Strategies to Open Occluded Coronary Arteries moderate/severe bleeding similarly in patients with PAD ( hazard ratio 1.47 , 95 % CI 0.89-2 .45 ) and without ( hazard ratio 1.48 , 95 % CI 1.22-1 .79 ; P interaction = .921 ) .
CONCLUSIONS	Patients with NSTE ACS and PAD were at increased risk for ischemic events .
CONCLUSIONS	Lower rates of ischemic end points , peripheral revascularization , and amputation with vorapaxar did not reach statistical significance but warrant further investigation .
CONCLUSIONS	Vorapaxar increased bleeding in both patients with and without PAD at a similar magnitude of risk .

###25217066
BACKGROUND	This study sought to investigate the relationship of polymorphisms in ABCB1 and the predictive value of thromboelastography ( TEG ) on bleeding risk in clopidogrel-treated patients with ST-elevation myocardial infarction ( STEMI ) .
METHODS	467 consecutive patients with STEMI undergoing percutaneous coronary intervention ( PCI ) were enrolled .
METHODS	Twenty tag single nucleotide polymorphisms ( SNPs ) selected from ABCB1 gene and CYP2C19 * 2 , * 3 , * 17 were detected by the ligase detection reaction .
METHODS	Platelet reactivity was assessed by TEG .
METHODS	The follow-up period was 12months .
RESULTS	By receiver operating characteristic curve analysis , the TEG platelet mapping assay value of ADP inhibition had the best predictive value of bleeding academic research consortium definition ( BARC ) 3b bleedings , yielding an area under the curve ( AUC ) of 0.707 ( 95 % CI 0.662-0 .749 , p = 0.009 ; cut-off value > 93.4 % ) .
RESULTS	ADP inhibition can also predict BARC 3 bleedings with an AUC of 0.594 ( 95 % CI 0.546-0 .640 , p = 0.05 ; cut-off value > 92.5 % ) .
RESULTS	After adjustment for established risk factors of bleeding including the gain of function CYP2C19 * 17 allele , age , female gender , renal function , the multivariable logistic regression model demonstrated that ADP inhibition > 92.5 % ( OR 2.247 , 95 % CI 1.082-4 .665 , P = 0.03 ) , carriage of rs1045642 ( OR 2.943 , 95 % CI 1.195-7 .247 , P = 0.019 ) and rs7779562 ( OR 0.453 , 95 % CI 0.219-0 .936 , P = 0.032 ) were independent predictors of BARC 3 bleedings .
RESULTS	These associations were validated in a second cohort of 504 STEMI patients .
CONCLUSIONS	In STEMI patients treated with clopidogrel after PCI , the ABCB1 tag SNP rs1045642 is associated with higher risk of bleedings while rs7779562 is associated with lower bleeding risk , and ADP inhibition in TEG has a predictive value of bleedings .

###25376862
BACKGROUND	The growing demand for cancer genetic services underscores the need to consider approaches that enhance access and efficiency of genetic counseling .
BACKGROUND	Telephone delivery of cancer genetic services may improve access to these services for individuals experiencing geographic ( rural areas ) and structural ( travel time , transportation , childcare ) barriers to access .
METHODS	This cluster-randomized clinical trial used population-based sampling of women at risk for BRCA1/2 mutations to compare telephone and in-person counseling for : 1 ) equivalency of testing uptake and 2 ) noninferiority of changes in psychosocial measures .
METHODS	Women 25 to 74 years of age with personal or family histories of breast or ovarian cancer and who were able to travel to one of 14 outreach clinics were invited to participate .
METHODS	Randomization was by family .
METHODS	Assessments were conducted at baseline one week after pretest and post-test counseling and at six months .
METHODS	Of the 988 women randomly assigned , 901 completed a follow-up assessment .
METHODS	Cluster bootstrap methods were used to estimate the 95 % confidence interval ( CI ) for the difference between test uptake proportions , using a 10 % equivalency margin .
METHODS	Differences in psychosocial outcomes for determining noninferiority were estimated using linear models together with one-sided 97.5 % bootstrap CIs .
RESULTS	Uptake of BRCA1/2 testing was lower following telephone ( 21.8 % ) than in-person counseling ( 31.8 % , difference = 10.2 % , 95 % CI = 3.9 % to 16.3 % ; after imputation of missing data : difference = 9.2 % , 95 % CI = -0.1 % to 24.6 % ) .
RESULTS	Telephone counseling fulfilled the criteria for noninferiority to in-person counseling for all measures .
CONCLUSIONS	BRCA1/2 telephone counseling , although leading to lower testing uptake , appears to be safe and as effective as in-person counseling with regard to minimizing adverse psychological reactions , promoting informed decision making , and delivering patient-centered communication for both rural and urban women .

###25049315
OBJECTIVE	To investigate the relation of residual worst lead ST segment elevation ( WL-STE ) after ST segment myocardial infarction ( STEMI ) with infarct size and microvascular injury assessed by cardiovascular magnetic resonance ( CMR ) imaging .
BACKGROUND	WL-STE in patients with acute reperfused STEMI has been shown to identify high risk patients for major adverse cardiovascular events ( MACE ) .
BACKGROUND	However , the relation of WL-STE with myocardial damage is unknown .
METHODS	In this multicentre study we analysed ECG data 90min after primary percutaneous coronary intervention ( PCI ) in 763 STEMI patients .
METHODS	WL-STE was defined as the absolute magnitude of STE in the most affected lead on the post-PCI ECG .
METHODS	Patients were categorised into three groups ( < 1mm , 1-2mm , and 2mm ) .
METHODS	CMR was performed within 1week after infarction for comprehensive assessment of myocardial damage using a standardised protocol .
METHODS	The primary clinical endpoint was MACE defined as death , reinfarction , and new congestive heart failure within 12months after infarction .
RESULTS	WL-STE < 1mm , 1-2mm , and 2mm was present in 155 ( 20 % ) , 328 ( 43 % ) , and 280 ( 37 % ) patients , respectively .
RESULTS	Myocardial damage determined by CMR demonstrated a graded relationship of infarct size ( median ( IQR ) 13.3 ( 6.2-20 .3 ) % LV vs 13.7 ( 7.6-21 .3 ) % LV vs 22.5 ( 15.6-31 .2 ) % LV , p < 0.001 ) , the myocardial salvage index ( 60.8 ( 37.0-84 .5 ) vs 55.0 ( 36.6-73 .9 ) vs 42.7 ( 26.2-58 .2 ) , p < 0.001 ) , and microvascular obstruction ( 0.0 ( 0.0-0 .9 ) % LV vs 0.0 ( 0-1 .0 ) % LV vs 1.2 ( 0.0-3 .6 ) % LV , p < 0.001 ) across the three groups .
RESULTS	WL-STE 2mm was strongly associated with MACE 12month after infarction ( HR 1.93 , 95 % CI 1.11 to 3.37 ; p = 0.02 ) .
CONCLUSIONS	This largest CMR study to date correlating post-PCI WL-STE with markers of myocardial damage demonstrates that WL-STE is significantly associated with infarct size , myocardial salvage , microvascular obstruction , and MACE in a high risk STEMI population .
BACKGROUND	NCT00712101 .

###25148580
OBJECTIVE	The role of planning in binge eating episodes is unknown .
OBJECTIVE	We investigated the characteristics of planning associated with food cues in binging patients .
OBJECTIVE	We studied planning based on backward reasoning , reasoning that determines a sequence of actions back to front from the final outcome .
METHODS	A cross-sectional study was conducted with 20 healthy participants , 20 bulimia nervosa ( BN ) , 22 restrictive ( ANR ) and 23 binging anorexia nervosa ( ANB ) , without any concomitant impulsive disorder .
METHODS	In neutral/relaxing , binge food and stressful conditions , backward reasoning was assessed with the Race game , promotion of delayed large rewards with an intertemporal discounting task , attention with the Simon task , and repeating a dominant behavior with the Go/No-go task .
RESULTS	BN and to a lower extent ANB patients succeeded more at the Race game in food than in neutral condition .
RESULTS	This difference discriminated binging from non-binging participants .
RESULTS	Backward reasoning in the food condition was associated with lower approach behavior toward food in BN patients , and higher food avoidance in ANB patients .
RESULTS	Enhanced backward reasoning in the food condition related to preferences for delayed large rewards in BN patients .
RESULTS	In BN and ANB patients the enhanced success rate at the Race game in the food condition was associated with higher attention paid to binge food .
CONCLUSIONS	These findings introduce a novel process underlying binges : planning based on backward reasoning is associated with binges .
CONCLUSIONS	It likely aims to reduce craving for binge foods and extend binge refractory period in BN patients , and avoid binging in ANB patients .
CONCLUSIONS	Shifts between these goals might explain shifts between eating disorder subtypes .

###25277343
OBJECTIVE	The reported incidence of injuries due to cardiopulmonary resuscitation using manual chest compressions ( manual CPR ) varies greatly .
OBJECTIVE	Our aim was to elucidate the incidence of CPR-related injuries by manual chest compressions compared to mechanical chest compressions with the LUCAS device ( mechanical CPR ) in non-survivors after out-of-hospital cardiac arrest .
METHODS	In this prospective multicentre trial , including 222 patients ( 83 manual CPR/139 mechanical CPR ) , autopsies were conducted after unsuccessful CPR and the results were evaluated according to a specified protocol .
RESULTS	Among the patients included , 75.9 % in the manual CPR group and 91.4 % in the mechanical CPR group ( p = 0.002 ) displayed CPR-related injuries .
RESULTS	Sternal fractures were present in 54.2 % of the patients in the manual CPR group and in 58.3 % in the mechanical CPR group ( p = 0.56 ) .
RESULTS	Of the patients in the manual CPR group , there were 64.6 % with at least one rib fracture versus 78.8 % in the mechanical CPR group ( p = 0.02 ) .
RESULTS	The median number of rib fractures among patients with rib fractures was 7 in the manual CPR group and 6 in the mechanical CPR group .
RESULTS	No CPR-related injury was considered to be the cause of death .
CONCLUSIONS	In patients with unsuccessful CPR after out-of-hospital cardiac arrest , rib fractures were more frequent after mechanical CPR but there was no difference in the incidence of sternal fractures .
CONCLUSIONS	No injury was deemed fatal by the pathologist .

###24836213
BACKGROUND	Anecdotal reports suggest that clopidogrel may prevent migraine attacks .
BACKGROUND	We undertook a pilot randomised trial .
METHODS	We randomised consecutive migraineurs with four to 15 headache days per 28-day month to receive clopidogrel 75mg or placebo daily for three months .
METHODS	Headache was primarily assessed with a headache diary .
RESULTS	There were no statistically significant treatment effects .
RESULTS	The number of headache days fell by 1.9 on clopidogrel and 1.6 on placebo ( adjusted difference 0.02 , CI -2.07 to 2.12 ) .
RESULTS	Headache severity rose by 0.14 points ( out of 10 ) on clopidogrel , and fell by 0.63 on placebo ; treatment effect 0.7 points ( CI -0.11 to 1.57 ) .
RESULTS	The main treatment effect did not depend on the presence or absence of migraine with aura at baseline , a patent foramen ovale ( PFO ) or atrial septal aneurysm .
CONCLUSIONS	The evidence is inconclusive , but a multicentre trial would be feasible recruiting from primary care .

###24947754
BACKGROUND	Pre-hospital emergency care is a particularly vulnerable setting for workplace violence .
BACKGROUND	However , there is no literature available to date on the psychological consequences of violence in pre-hospital emergency care .
OBJECTIVE	To evaluate the psychological consequences of exposure to workplace violence from patients and those accompanying them in pre-hospital emergency care .
METHODS	A retrospective cross-sectional study .
METHODS	70 pre-hospital emergency care services located in Madrid region .
METHODS	A randomized sample of 441 health care workers ( 135 physicians , 127 nurses and 179 emergency care assistants ) .
METHODS	Data were collected from February to May 2012 .
METHODS	The survey was divided into four sections : demographic/professional information , level of burnout determined by Maslach Burnout Inventory ( MBI ) , mental health status using General Health Questionnaire ( GHQ-28 ) and frequency and type of violent behaviour experienced by staff members .
RESULTS	The health care professionals who had been exposed to physical and verbal violence presented a significantly higher percentage of anxiety , emotional exhaustion , depersonalization and burnout syndrome compared with those who had not been subjected to any aggression .
RESULTS	Frequency of verbal violence ( more than five times ) was related to emotional exhaustion and depersonalization .
CONCLUSIONS	Type of violence ( i.e. physical aggression ) is especially related to high anxiety levels and frequency of verbal aggression is associated with burnout ( emotional exhaustion and depersonalization ) .
CONCLUSIONS	Psychological counselling should be made available to professional staff who have been subjected to physical aggression or frequent verbal violence .

###25414931
BACKGROUND	Lorcaserin , a novel selective 5-HT2C receptor agonist , is approved by the US Food and Drug Administration ( FDA ) for weight management in combination with lifestyle modification for adults with obesity and adults with overweight and 1 weight-related comorbid condition .
BACKGROUND	The safety and effectiveness of lorcaserin in adult patients without type 2 diabetes mellitus was established based on 2 phase III clinical trials of similar design : Behavioral Modification and Lorcaserin for Overweight and Obesity Management ( BLOOM ) and Behavioral Modification and Lorcaserin Second Study for Obesity Management ( BLOSSOM ) .
BACKGROUND	This report presents a prespecified analysis of pooled data from these trials .
METHODS	Co-primary end points in this analysis include the proportion of patients with a reduction in baseline body weight of 5 % and 10 % , and a change in weight from baseline .
METHODS	Key secondary end points include changes from baseline values in lipid parameters , quality-of-life measures , glycemic indicators , and vital signs .
RESULTS	At week 52 , more than twice as many lorcaserin-treated patients achieved a weight loss of 5 % compared with placebo ( lorcaserin , 47.1 % ; placebo , 22.6 % ) , and lorcaserin-treated patients lost significantly more body weight ( lorcaserin , -5.8 % ; placebo , -2.5 % ) .
RESULTS	A significantly greater proportion of lorcaserin-treated patients achieved a weight loss of 10 % ( lorcaserin , 22.4 % ; placebo , 8.7 % ) .
RESULTS	There were statistically significant improvements in lipid parameters , glycemic indicators , quality-of-life measures , and vital signs in the lorcaserin group compared with placebo .
RESULTS	The most common adverse events associated with lorcaserin treatment were headache , upper respiratory tract infection , and nasopharyngitis .
RESULTS	Lorcaserin-treated patients had a rate of FDA-defined valvulopathy similar to placebo .
CONCLUSIONS	This pooled analysis of the phase III BLOOM and BLOSSOM trials shows that lorcaserin 10 mg twice daily , in combination with diet and exercise , is safe and tolerable , and is associated with statistically significant weight loss and clinically relevant improvements in cardiometabolic parameters .

###26154185
BACKGROUND	A novel multidimensional index of nociception , the nociception level ( NoL ) index , derived from the nonlinear composite of heart rate ( HR ) , HR variability , amplitude of the photoplethysmogram , skin conductance , fluctuations in skin conductance , and their time derivatives , was used to assess nociception during anesthesia .
METHODS	Seventy-two American Society of Anesthesiologists I to III patients received propofol ( target bispectral index , 45 ) and one of six remifentanil target concentrations in the range of 0 to 5 ng/ml .
METHODS	The NoL , mean arterial pressure ( MAP ; derived from a beat-to-beat finger cuff measurement ) , and HR were measured during nonnoxious , moderate noxious ( skin incision ) , and intense noxious ( intubation ) stimulation .
METHODS	Values are represented as average ( 95 % CI ) .
RESULTS	NoL , HR , and MAP did not change during nonnoxious events .
RESULTS	Incision increased HR by 1.3 / min ( -0.46 to 3.1 / min ; not significant ) , MAP by 7.9 mmHg ( -1.9 to 13.0 mmHg ; not significant ) , and NoL by 8.0 ( 0.4 to 16.0 ; P < 0.001 ) .
RESULTS	Intubation increased HR by 7.0 / min ( 1.4 to 12.0 / min ; P < 0.001 ) , MAP by 13.0 mmHg ( 3.1 to 20 mmHg ; P < 0.001 ) , and NoL by 18.0 ( 7.8 to 29.0 ; P < 0.001 ) .
RESULTS	The NoL area under the curve ( 0.95 ) of the receiver operating characteristic curve was greater compared with HR ( 0.84 , P < 0.001 ) and MAP ( 0.78 , P < 0.001 ) .
RESULTS	Under nonnociceptive conditions , remifentanil had no effect on NoL , in contrast to HR and MAP that showed a dose-dependent decrease .
CONCLUSIONS	The NoL is a reliable measure of moderate and intense noxious stimulation and outperforms HR and MAP in differentiating noxious from nonnoxious stimuli .
CONCLUSIONS	In contrast to HR and MAP , the NoL was not affected by hemodynamic effects of remifentanil .

###24473364
OBJECTIVE	The objective of this study was to assess the evolution of T1 contrast ( T1c ) between cardiovascular tissues , contrast agents , and magnetic field strengths .
METHODS	This Health Insurance Portability and Accountability Act-compliant study was approved by the institutional review board , and written informed consent was obtained from all participants .
METHODS	Eight healthy volunteers were recruited to undergo 4 consecutive magnetic resonance ( MR ) scans with the same imaging parameters .
METHODS	Scans 1 and 2 were performed using a 3-T MR scanner , and scans 3 and 4 were performed using a 1.5-T MR scanner .
METHODS	Gadofosveset trisodium ( 0.03 mmol/kg ) was injected for scans 1 and 3 , and gadopentetate dimeglumine ( Gd-DTPA ) ( 0.1 mmol/kg ) was used for scans 2 and 4 .
METHODS	Modified Look-Locker inversion recovery T1 maps with a midventricular short-axis view were acquired before contrast and repeated every 5 minutes until 45 minutes after contrast agent administration .
METHODS	T1 contrast tissue ( T1 ( myocardium ) - T1 ( blood ) ) , T1c agent ( T1Gd-DTPA - T1 ( Gadofosveset ) ) , and T1c field ( T1 ( 3T ) - T1 ( 1.5 T ) ) were calculated and compared using t tests .
RESULTS	The T1c tissue of the 3-T scanner was larger than that of the 1.5-T scanner for both contrast agents .
RESULTS	In both the myocardium and the blood pool , the T1c agent of the 1.5-T scanner was larger than that of the 3-T scanner .
RESULTS	Gadofosveset trisodium exhibited a larger T1c field and T1c tissue than did Gd-DTPA .
RESULTS	The T1c tissue induced by Gd-DTPA diminished faster than that induced by gadofosveset trisodium at both 1.5 and 3 T.
CONCLUSIONS	Our study demonstrates the independent effects of timing , contrast agent type , and magnetic field strength on postcontrast T1c under general physiological conditions .
CONCLUSIONS	The behaviors of T1c can be used to tailor quantitative MR imaging protocols for various clinical purposes .

###25148183
OBJECTIVE	The purpose of this study was to evaluate the diagnostic accuracy of real-time shear-wave elastography for assessment of liver fibrosis in an unselected patient population , comparing shear-wave elastography measurements obtained at and remote from the site of random liver biopsy .
METHODS	In a prospective study of 50 patients ( 21 with and 29 without hepatitis C ) referred for clinically indicated random liver biopsy for diffuse liver disease , shear-wave elastography measurements were taken from four locations before biopsy : one at the left lobe , two at the right lobe , and one at the biopsy location .
METHODS	The mean , minimum , maximum , and SD of shear-wave elastography were compared with pathologic grading .
METHODS	Steatosis and serum markers were analyzed using multiple logistic regression .
METHODS	Optimized shear-wave elastography thresholds were calculated using AUC analysis .
RESULTS	The AUC ( 95 % CI ) at the biopsy site , ipsilateral lobe , and contralateral lobe were 0.82 ( 0.63-1 .0 ) , 0.84 ( 0.67-1 .0 ) , and 0.59 ( 0.19-0 .99 ) in hepatitis C patients ; 0.89 ( 0.75-1 .0 ) , 0.88 ( 0.73-1 .0 ) , and 0.93 ( 0.80-1 .0 ) in nonhepatitis C patients ; and 0.85 ( 0.74-0 .96 ) , 0.89 ( 0.79-0 .99 ) , and 0.80 ( 0.67-0 .93 ) in all patients , respectively .
RESULTS	Optimized biopsy site shear-wave elastography values for detecting Metavir score F2 or greater were 1.87 m/s ( 75 % sensitivity and specificity ) , 2.00 m/s ( 80 % sensitivity and specificity ) , and 1.89 m/s ( 76 % sensitivity and specificity ) in hepatitis C , nonhepatitis C , and all patients , respectively .
RESULTS	Steatosis and serum markers were not significant .
CONCLUSIONS	Real-time shear-wave elastography accurately predicted significant fibrosis ( stage 2 ) in an unselected patient population with diffuse disease , including patients with and without hepatitis C. Shear-wave elastography best predicts pathologic grading when taken at the biopsy site or ipsilateral lobe in hepatitis C patients .
CONCLUSIONS	Percentage steatosis was not predictive of shear-wave elastography results .

###25596960
OBJECTIVE	We evaluate patients with shock and traumatic brain injury who were previously enrolled in an out-of-hospital clinical trial to test the association between out-of-hospital time and outcome .
METHODS	This was a secondary analysis of patients with shock and traumatic brain injury who were aged 15 years or older and enrolled in a Resuscitation Outcomes Consortium out-of-hospital clinical trial by 81 emergency medical services agencies transporting to 46 Level I and II trauma centers in 11 sites ( May 2006 through May 2009 ) .
METHODS	Inclusion criteria were systolic blood pressure less than or equal to 70 mm Hg or systolic blood pressure 71 to 90 mm Hg with pulse rate greater than or equal to 108 beats/min ( shock cohort ) and Glasgow Coma Scale score less than or equal to 8 ( traumatic brain injury cohort ) ; patients meeting both criteria were placed in the shock cohort .
METHODS	Primary outcomes were 28-day mortality ( shock cohort ) and 6-month Glasgow Outcome Scale-Extended score less than or equal to 4 ( traumatic brain injury cohort ) .
RESULTS	There were 778 patients in the shock cohort ( 26 % 28-day mortality ) and 1,239 patients in the traumatic brain injury cohort ( 53 % 6-month Glasgow Outcome Scale-Extended score 4 ) .
RESULTS	Out-of-hospital time greater than 60 minutes was not associated with worse outcomes after accounting for important confounders in the shock cohort ( adjusted odds ratio [ aOR ] 1.42 ; 95 % confidence interval [ CI ] 0.77 to 2.62 ) or traumatic brain injury cohort ( aOR 0.77 ; 95 % CI 0.51 to 1.15 ) .
RESULTS	However , shock patients requiring early critical hospital resources and arriving after 60 minutes had higher 28-day mortality ( aOR 2.37 ; 95 % CI 1.05 to 5.37 ) ; this finding was not observed among a similar traumatic brain injury subgroup .
CONCLUSIONS	Among out-of-hospital trauma patients meeting physiologic criteria for shock and traumatic brain injury , there was no association between time and outcome .
CONCLUSIONS	However , the subgroup of shock patients requiring early critical resources and arriving after 60 minutes had higher mortality .

###24465958
OBJECTIVE	Noncompliance with scheduled ambulatory saliva sampling is common and has been associated with biased cortisol estimates in nonpregnant subjects .
OBJECTIVE	This study is the first to investigate in pregnant women strategies to improve ambulatory saliva-sampling compliance , and the association between sampling noncompliance and saliva cortisol estimates .
METHODS	We instructed 64 pregnant women to collect eight scheduled saliva samples on two consecutive days each .
METHODS	Objective compliance with scheduled sampling times was assessed with a Medication Event Monitoring System and self-reported compliance with a paper-and-pencil diary .
METHODS	In a randomized controlled study , we estimated whether a disclosure intervention ( informing women about objective compliance monitoring ) and a reminder intervention ( use of acoustical reminders ) improved compliance .
METHODS	A mixed model analysis was used to estimate associations between women 's objective compliance and their diurnal cortisol profiles , and between deviation from scheduled sampling and the cortisol concentration measured in the related sample .
RESULTS	Self-reported compliance with a saliva-sampling protocol was 91 % , and objective compliance was 70 % .
RESULTS	The disclosure intervention was associated with improved objective compliance ( informed : 81 % , noninformed : 60 % ) , F ( 1,60 ) = 17.64 , p < 0.001 , but not the reminder intervention ( reminders : 68 % , without reminders : 72 % ) , F ( 1,60 ) = 0.78 , p = 0.379 .
RESULTS	Furthermore , a woman 's increased objective compliance was associated with a higher diurnal cortisol profile , F ( 2,64 ) = 8.22 , p < 0.001 .
RESULTS	Altered cortisol levels were observed in less objective compliant samples , F ( 1,705 ) = 7.38 , p = 0.007 , with delayed sampling associated with lower cortisol levels .
CONCLUSIONS	The results suggest that in pregnant women , objective noncompliance with scheduled ambulatory saliva sampling is common and is associated with biased cortisol estimates .
CONCLUSIONS	To improve sampling compliance , results suggest informing women about objective compliance monitoring but discourage use of acoustical reminders .

###25010443
BACKGROUND	There is currently little evidence defining the clinical importance of detecting and treating isolated distal DVT ( IDDVT ) .
BACKGROUND	International guidelines vary regarding diagnostic and therapeutic advice .
BACKGROUND	The potential benefits of anticoagulation are unquantified .
BACKGROUND	We sought to evaluate the feasibility of a randomized controlled study within a modern framework and provide a primary outcome point estimate .
METHODS	In this open-label , external pilot randomized controlled trial , consecutive , symptomatic , ambulatory patients with IDDVT were approached for inclusion .
METHODS	Participants were allocated to receive either therapeutic anticoagulation or conservative management .
METHODS	Patients underwent blinded color-duplex imaging at 7 and 21 days and follow-up at 3 months .
METHODS	Principal feasibility outcomes included recruitment rate and attrition .
METHODS	The principal clinical outcome was a composite including proximal propagation , pulmonary embolism , death attributable to VTE disease , or major bleeding .
METHODS	Analysis was by intention to treat .
RESULTS	In total , 93 patients with IDDVT were screened , and 70 of those eligible ( 88.6 % ) were recruited .
RESULTS	All patients but one were followed-up by direct contact after 90 days .
RESULTS	Allocation crossover occurred in 15 patients ( 21.4 % ) .
RESULTS	The principal clinical outcome occurred in four of 35 of those conservatively treated ( 11.4 % ) and zero of 35 in the anticoagulated group ( absolute risk reduction , 11.4 % ; 95 % CI , -1.5 to 26.7 , P = .11 , number needed to treat of nine ) .
RESULTS	There were no major bleeding episodes .
CONCLUSIONS	We have established the feasibility of definitive study regarding the value of therapeutic anticoagulation in IDDVT and provide an approximate point estimate for serious complications with a contemporary conservative strategy .
BACKGROUND	Current Controlled Trials ; No. : ISRCTN75175695 ; URL : www.controlled-trials.com .

###25597529
BACKGROUND	Considering both the burden determined by major depressive disorder ( MDD ) itself and the high refractoriness and recurrence index , alternative strategies , such as trigeminal nerve stimulation ( TNS ) , are the cutting edge instruments to optimize clinical response and to avoid treatment discontinuation and relapse of symptoms .
BACKGROUND	Trigeminal nerve stimulation is an incipient simple , low-cost interventional strategy based on the application of an electric current over a branch of the trigeminal nerve with further propagation of the stimuli towards brain areas related to mood symptoms .
METHODS	The study was a phase II , randomized , sham-controlled trial with 40 patients with MDD .
METHODS	Patients with moderate or severe depressive symptoms as assessed by adequate clinical scales underwent a 10-day intervention protocol .
METHODS	Regarding main clinical outcome , analysis of variance ( ANOVA ) was performed to evaluate mean change scores in depressive symptoms as assessed by the HDRS-17 between baseline ( t1 ) , after intervention protocol ( t2 ) , and during one-month follow-up ( t3 ) .
RESULTS	There was a significant interaction between the mean percentage changes in depressive symptoms according to the HDRS in the two groups across the three assessments ( F = 6.38 , df = 2 , p = 0.0033 ) .
RESULTS	Post hoc analyses ( Bonferroni method ) demonstrated a statistically significant difference between depressive symptoms at baseline and t1 ( p = 0.01 ) and between depressive symptoms at baseline and t2 ( p = 0.009 ) .
RESULTS	No severe adverse effects were reported .
CONCLUSIONS	Our results in the present controlled trial highlight the possibility of more practical treatment protocols for clinical research , which are similar to those for different neuromodulation strategies such as transcranial direct current stimulation ( tDCS ) .
CONCLUSIONS	The in-office administration of TNS in our protocol is similar to the schedule for repetitive transcranial magnetic stimulation ( rTMS ) , though over fewer treatment sessions .
CONCLUSIONS	Further controlled studies will contribute to the establishment of the clinical relevance of this new treatment strategy for MDD .

###24227357
BACKGROUND	Moderate wound pain and opiate analgesia requirement is reported following thyroid and parathyroid surgery .
BACKGROUND	A randomized clinical trial was performed to investigate whether intraoperative superficial cervical plexus block ( SCPB ) would decrease postoperative pain and analgesia use .
METHODS	Patients were randomized to incisional local anaesthesia ( control ) or incisional local anaesthesia plus intraoperative SCPB .
METHODS	The primary outcome measure was pain , assessed by a visual analogue scale ( VAS ) .
METHODS	Secondary outcome measures were analgesia use ( strong opiates defined as having potency at least as strong as that of oral morphine ) , respiratory rate and sedation score .
METHODS	Primary outcome measures were analysed with non-parametric tests , as well as with receiver operating characteristic ( ROC ) curves calculated as area under the curve ( AUC ) to discriminate between trial limbs .
RESULTS	Twenty-nine patients were randomized to each group .
RESULTS	Pain ( VAS ) scores were lower in patients who received intraoperative SCPB than in controls 30min after surgery and subsequently ( P < 0020 at all time points ) , with a median pain score of zero on the day of operation in the SCPB group .
RESULTS	Corresponding analysis of ROC curves showed differences between groups at 30min ( AUC = 0722 , P = 0012 ) , 90min ( AUC = 0747 , P = 0005 ) , 150min ( AUC = 0803 , P < 0001 ) and 210min ( AUC = 0849 , P < 0001 ) after surgery , and at 07.00 hours on postoperative day 1 ( AUC = 0710 , P = 0017 ) .
RESULTS	Fewer patients in the SCPB group required strong opiates ( 5 of 29 versus 16 of 29 in the control group ; P = 0003 ) and rescue opiates ( 6 of 29 versus 20 of 29 ; P < 0001 ) .
CONCLUSIONS	Intraoperative SCPB reduces pain scores following thyroid and parathyroid surgery , and reduces the requirement for strong and rescue opiates .
BACKGROUND	2009-012671-98 ( https://www.clinicaltrialsregister.eu ) .

###25562195
BACKGROUND	Elevated blood viscosity is a risk factor for atherosclerosis , thrombosis and other cardiovascular events .
BACKGROUND	Our previous studies have suggested that consumption of Yerba mate tea ( Ilex paraguariensis ) has strong antioxidant and lipid-lowering properties in animals .
BACKGROUND	The in vivo effects of Yerba mate on blood viscosity in humans , however , have not been studied .
OBJECTIVE	This study aims to investigate the effect of Yerba mate tea on the reduction of blood viscosity and the improvement of microcirculatory parameters commonly regarded as risk factors for serious cardio and cerebrovascular disorders .
METHODS	142 subjects with high blood viscosity were recruited in this randomized , double-blind , placebo-controlled study .
METHODS	Yerba mate tea or placebo ( 5 g/day ) was administered to different groups for 6 weeks .
METHODS	After treatment , results of hemorheological indexes , nailfold microcirculation , 6-keto-PGF1 and TXB2 and lipid profiles of subjects in the Yerba mate tea group were compared with those in the placebo-receiving group .
RESULTS	Parameters of blood viscosity and microcirculation were improved in the subjects from the Yerba mate tea group but not in placebo-receiving patients .
RESULTS	After treatment , whole blood viscosity , plasma viscosity and the Equation K value of erythrocyte sedimentation rate ( ESRK ) decreased significantly in the Yerba mate group .
RESULTS	Meanwhile , shape , flow state and nailfold microcirculation appeared positively changed .
RESULTS	Specifically , blood flow speeds accelerated gradually and nailfold weighted integral values decreased significantly .
RESULTS	Moreover , the vasodilator 6-keto PGF1 increased while the thromboxane TXB2 decreased in serum samples of subjects in the Yerba mate-receiving group .
RESULTS	Overall , Yerba mate tea-receiving subjects saw nearly all measured values improve to levels comparable to those characteristic of patients with normal microcirculation .
CONCLUSIONS	These results indicate the therapeutic capacity of Yerba mate tea in the treatment of high blood viscosity .
CONCLUSIONS	Here , Yerba mate tea played a role in the regulation of various indexes of hemorheology , nailfold microcirculation , and the platelet aggregating factors 6-keto-PGF1a and TXB2 .
CONCLUSIONS	The regulation of these might be correlated with reduced blood viscosity and accelerating blood flow .
CONCLUSIONS	Thus , Yerba mate tea may reduce some key risk-factors of cardiovascular disease .
CONCLUSIONS	Daily consumption of Yerba mate tea may be a better-tolerated option for individuals with high blood viscosity and microcirculatory disturbance and as such , a novel preventative strategy for patients at-risk for vascular disease .

###25719991
OBJECTIVE	For the management of retinal disease , the use of intravitreous injections of anti-vascular endothelial growth factor has increased .
OBJECTIVE	Recent reports have suggested that this therapy may cause sustained elevation of intraocular pressure ( IOP ) and may potentially increase the risk of glaucoma for patients with retinal disease .
OBJECTIVE	To assess the risk of sustained IOP elevation or the need for IOP-lowering treatments for eyes with diabetic macular edema following repeated intravitreous injections of ranibizumab .
METHODS	An exploratory analysis was conducted within a Diabetic Retinopathy Clinical Research Network randomized clinical trial .
METHODS	Study enrollment dates were from March 20 , 2007 , to December 17 , 2008 .
METHODS	Of 582 eyes ( of 486 participants ) with center-involved diabetic macular edema and no preexisting open-angle glaucoma , 260 were randomly assigned to receive a sham injection plus focal/grid laser treatment , and 322 were randomly assigned to receive ranibizumab plus deferred or prompt focal/grid laser treatment .
METHODS	The cumulative probability of sustained IOP elevation , defined as IOP of at least 22 mm Hg and an increase of at least 6 mm Hg from baseline at 2 consecutive visits , or the initiation or augmentation of ocular hypotensive therapy , through 3 years of follow-up .
RESULTS	The mean ( SD ) baseline IOP in both treatment groups was 16 ( 3 ) mm Hg ( range , 5-24 mm Hg ) .
RESULTS	The cumulative probability of sustained IOP elevation or of initiation or augmentation of ocular hypotensive therapy by 3 years , after repeated ranibizumab injections , was 9.5 % for the participants who received ranibizumab plus prompt or deferred focal/grid laser treatment vs 3.4 % for the participants who received a sham injection plus focal/grid laser treatment ( difference , 6.1 % [ 99 % CI , -0.2 % to 12.3 % ] ; hazard ratio , 2.9 [ 99 % CI , 1.0-7 .9 ] ; P = .01 ) .
RESULTS	The distribution of IOP and the change in IOP from baseline at each visit through 3 years were similar in each group .
CONCLUSIONS	In eyes with center-involved diabetic macular edema and no prior open-angle glaucoma , repeated intravitreous injections of ranibizumab may increase the risk of sustained IOP elevation or the need for ocular hypotensive treatment .
CONCLUSIONS	Clinicians should be aware of this risk and should consider this information when following up with patients who have received intravitreous injections of anti-vascular endothelial growth factor for the treatment of diabetic macular edema .

###24290801
OBJECTIVE	To compare outcomes of intravitreal therapy from an observational study cohort with those of participants receiving treatment in the Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab ( MARINA ) for the treatment of neovascular age-related macular degeneration ( wet AMD ) .
METHODS	Database observational study .
METHODS	Participants in the observational cohort were chosen to match demographic features and entry criteria of the treatment group from MARINA .
METHODS	Outcomes over 12 months were compared .
METHODS	Eight hundred twenty-one anti-vascular endothelial growth factor ( anti-VEGF ) - nave eyes treated with ranibizumab with 12 months or more of follow-up were included in the total Fight Retinal Blindness !
METHODS	( FRB-All ) cohort , whereas a subset of this cohort of 401 eyes who were matched to the MARINA treatment group were included as the FRB-MARINA cohort .
METHODS	Intravitreal ranibizumab therapy of 0.5 mg for wet AMD .
METHODS	Visual acuity ( VA ) in logarithm of the minimum angle of resolution ( logMAR ) letters and treatments given were recorded continuously and anonymously in an electronic database for 12 months .
METHODS	Locally weighted scatterplot smoothing ( LOESS ) regression was used to plot change in visual acuity data over the course of 12 months for both the FRB-All cohort and the FRB-MARINA cohort , whereas results from the MARINA trial were taken from the published study report .
METHODS	Change in VA in logMAR letters over 12 months , treatment , and visit intensity .
RESULTS	Mean visual acuity improvement after 12 months in FRB-MARINA ( +5.5 letters ) was similar to that of the 0.5-mg group from MARINA ( +7.2 letters ) .
RESULTS	Improvement in FRB-ALL was slightly less ( +4.9 letters ) .
RESULTS	Mean treatment effect compared with the MARINA control group was similar for the MARINA treated group ( +17.6 letters ) and the FRB-MARINA cohort ( +15.9 letters ) .
RESULTS	A mean of 7.3 injections in 12 months was received by the observational cohorts .
CONCLUSIONS	Similarity of mean VA improvement in the matched observational cohort with that of the phase 3 clinical trial suggests that these results can be achieved in real-world clinical practice with a modified treatment regimen .

###24410738
BACKGROUND	Interventions to support people with hypertension in attending clinics and taking their medication have potential to improve outcomes , but delivery on a wide scale and at low cost is challenging .
BACKGROUND	Some trials evaluating clinical interventions using short message service ( SMS ) text-messaging systems have shown important outcomes , although evidence is limited .
BACKGROUND	We have developed a novel SMS system integrated with clinical care for use by people with hypertension in a low-resource setting .
BACKGROUND	We aim to test the efficacy of the system in improving blood pressure control and treatment adherence compared to usual care .
METHODS	The SMS Text-message Adherence suppoRt trial ( StAR ) is a pragmatic individually randomised three-arm parallel group trial in adults treated for hypertension at a single primary care centre in Cape Town , South Africa .
METHODS	The intervention is a structured programme of clinic appointment , medication pick-up reminders , medication adherence support and hypertension-related education delivered remotely using an automated system with either informational or interactive SMS text-messages .
METHODS	Usual care is supplemented by infrequent non-hypertension related SMS text-messages .
METHODS	Participants are 1:1:1 individually randomised , to usual care or to one of the two active interventions using minimisation to dynamically adjust for gender , age , baseline systolic blood pressure , years with hypertension , and previous clinic attendance .
METHODS	The primary outcome is the change in mean systolic blood pressure at 12-month follow-up from baseline measured with research staff blinded to trial allocation .
METHODS	Secondary outcomes include the proportion of patients with 80 % or more of days medication available , proportion of participants achieving a systolic blood pressure less than 140mmHg and a diastolic blood pressure less than 90mmHg , hospital admissions , health status , retention in clinical care , satisfaction with treatment and care , and patient related quality of life .
METHODS	Anonymised demographic data are collected on non-participants .
CONCLUSIONS	The StAR trial uses a novel , low cost system based on widely available mobile phone technology to deliver the SMS-based intervention , manage communication with patients , and measure clinically relevant outcomes .
CONCLUSIONS	The results will inform implementation and wider use of mobile phone based interventions for health care delivery in a low-resource setting .
BACKGROUND	NCT02019823 .

###24921223
OBJECTIVE	FlexTouch ( FT ) is a new prefilled insulin pen with no push-button extension and a low injection force used to deliver several basal insulins , including insulin degludec across a wide dose range ( 1 - 80 units with FT 100 IU/ml [ FT100 ] and 2 - 160 units with 200 IU/ml [ FT200 ] ) .
OBJECTIVE	This study was carried out to evaluate whether the novel features of FT affect the preferences of the device among patients with diabetes and healthcare professionals compared with the widely used SoloSTAR pen .
METHODS	A multicenter , randomized , open-label , crossover study compared FT100 and FT200 with SoloSTAR .
METHODS	The study included patients with either type 1 ( n = 22 ) or type 2 diabetes ( n = 42 ) , nurses ( n = 32 ) and physicians ( n = 32 ) .
METHODS	Subjects were randomized to test each of the FT100 , FT200 and SoloSTAR pens in a crossover set up .
METHODS	Subjects performed injections into a foam cushion at 4 - 6 different doses per device ( 2 , 20 , 40 , 80 , 120 and 160 IU ) .
RESULTS	Overall , a significantly higher proportion of subjects , including dexterity-impaired and pen-naive patients , preferred to use FT100 ( 93.0 % ; 119/128 ) and FT200 ( 91.4 % ; 117/128 ) compared with 2.3 % ( 3/128 ) and 3.9 % ( 5/128 ) who preferred SoloSTAR ( p < 0.001 ) , respectively .
CONCLUSIONS	FT100 and FT200 were preferred over SoloSTAR by nurses , physicians and patients with diabetes .
CONCLUSIONS	This may be due to the novel design of FT , which improves ease of use , preference and confidence in delivering a complete , accurate dose of insulin , even at high doses .

###24988118
BACKGROUND	Suboptimal vitamin D status is prevalent in HIV-infected patients and associated with increased risk of disease severity and morbidity .
BACKGROUND	We aimed to determine 12-month safety and efficacy of daily 7000 IU vitamin D3 ( vitD3 ) versus placebo to sustain increased serum 25-hydroxyvitamin D ( 25 ( OH ) D ) and improve immune status in HIV-infected subjects .
METHODS	This was a double-blind trial of perinatally acquired HIV ( PHIV ) - infected subjects or behaviorally acquired HIV ( BHIV ) - infected subjects ( 5.0-24 .9 years ) .
METHODS	Safety , 25 ( OH ) D-related parameters and immune status were assessed at baseline , 3 , 6 and 12 months .
RESULTS	Fifty-eight subjects enrolled ( 67 % male , 85 % African American and 64 % BHIV ) and 50 completed with no safety concerns .
RESULTS	In unadjusted analyses , there were no differences between randomization groups at baseline ; at 3 , 6 and 12 months , 25 ( OH ) D was higher with supplementation than baseline and higher than with placebo ( P < 0.05 ) .
RESULTS	In adjusted mixed models , in the supplementation group , the fixed effect of 25 ( OH ) D was higher ( P < 0.001 ) .
RESULTS	Percentage of naive T-helper cells ( Th naive % ) were significantly ( P < 0.01 ) and T-helper cells ( CD4 % ) marginally ( P < 0.10 ) increased with supplementation in those taking highly active antiretroviral therapy ( HAART ) , and RNA viral load was reduced ( P 0.05 ) .
RESULTS	In exploratory linear models , change in 25 ( OH ) D predicted RNA viral load at 3 and 12 months and CD4 % at 3 months ( P < 0.05 ) .
CONCLUSIONS	Daily 7000 IU vitD3 for 12 months was safe in HIV-infected subjects and effective in increasing 25 ( OH ) D. Supplementation improved some clinically important HIV immune markers in subjects on HAART .
CONCLUSIONS	Adjunct therapy with high-dose , daily vitD3 for HIV-infected subjects and for those on/off HAART requires further investigation .

###25316180
OBJECTIVE	To evaluate the immediate effect of repetitive wrist extension on grip strength in patients with distal radial fracture .
METHODS	Interventional study .
METHODS	Patients who were admitted to a hospital department of occupational therapy .
METHODS	Consecutive patients with a unilateral distal radial fracture ( N = 28 ) .
METHODS	Each patient was randomly allocated to either the experimental group ( n = 14 ) or the control group ( n = 14 ) .
METHODS	The experimental group performed 30 repetitive wrist extensions with maximal isometric contraction of the extensors of their affected hands during a 6-minute intervention period , whereas the control group did not perform the exercise .
METHODS	Grip strength was measured just before and after the intervention period .
METHODS	Pain during grip strength measurements was also quantified using the visual analog scale .
METHODS	Wrist extension strength was measured 10 minutes after the grip strength measurement .
RESULTS	Grip strength increased immediately after repetitive wrist extension in the experimental group , but it remained the same in the control group .
RESULTS	Visual analog scale scores indicated that pain was relieved only in the experimental group .
RESULTS	However , pain was unrelated to strength production .
CONCLUSIONS	The intervention used in this study might be useful during physical examination to reveal the potential grip strength of patients .
CONCLUSIONS	The intervention may also be an effective warm-up training procedure in preparation for conventional grip-strengthening exercises .

###25030803
BACKGROUND	Preclinical and clinical data suggest that pregnenolone may be a promising therapeutic in schizophrenia .
BACKGROUND	Pregnenolone is neuroprotective and enhances learning and memory , myelination , and microtubule polymerization .
BACKGROUND	Treatment with pregnenolone elevates allopregnanolone ( a neurosteroid that enhances GABAA receptor responses ) and pregnenolone sulfate ( a positive NMDA receptor modulator ) .
BACKGROUND	Pregnenolone could thus potentially mitigate GABA dysregulation and/or NMDA receptor hypofunction in schizophrenia via metabolism to other neurosteroids .
OBJECTIVE	The objective of this study is to conduct a randomized controlled trial of adjunctive pregnenolone in schizophrenia .
METHODS	Following a placebo lead-in , 120 participants were randomized to pregnenolone or placebo for 8 weeks ( Institute for Mental Health , Singapore ) .
METHODS	Primary endpoints were changes in MATRICS Consensus Cognitive Battery ( MCCB ) composite scores ( cognitive symptoms ) , UCSD Performance-based Skills Assessment-Brief ( UPSA-B ) composite scores ( functional capacity ) , and Scale for Assessment of Negative Symptoms ( SANS ) total scores ( negative symptoms ) .
METHODS	A modified intent-to-treat analysis approach was utilized .
RESULTS	No significant changes compared to placebo were demonstrated in composite MCCB scores .
RESULTS	In contrast , participants randomized to pregnenolone ( n = 56 ) demonstrated greater improvements in functional capacity ( UPSA-B composite changes ) compared to placebo ( n = 55 ) , p = 0.03 .
RESULTS	Pregnenolone was also superior to placebo in the communication subscale of the UPSA-B ( p < 0.001 ) .
RESULTS	Serum pregnenolone changes post-treatment were correlated with UPSA-B composite score changes in females ( r s = 0.497 , p < 0.042 , n = 17 ) but not in males .
RESULTS	Mean total SANS scores were very low at baseline and did not improve further post-treatment .
RESULTS	Pregnenolone was well-tolerated .
CONCLUSIONS	Pregnenolone improved functional capacity in participants with schizophrenia , but did not improve cognitive symptoms over an 8-week treatment period .
CONCLUSIONS	Neurosteroid changes correlated with functional improvements in female participants .
CONCLUSIONS	Neurosteroid interventions may exhibit promise as new therapeutic leads for schizophrenia .

###24614693
BACKGROUND	Polyphenol-rich foods such as pomegranate , green tea , broccoli and turmeric have demonstrated anti-neoplastic effects in laboratory models involving angiogenesis , apoptosis and proliferation .
BACKGROUND	Although some have been investigated in small , phase II studies , this combination has never been evaluated within an adequately powered randomised controlled trial .
METHODS	In total , 199 men , average age 74 years , with localised prostate cancer , 60 % managed with primary active surveillance ( AS ) or 40 % with watchful waiting ( WW ) following previous interventions , were randomised ( 2:1 ) to receive an oral capsule containing a blend of pomegranate , green tea , broccoli and turmeric , or an identical placebo for 6 months .
RESULTS	The median rise in PSA in the food supplement group ( FSG ) was 14.7 % ( 95 % confidence intervals ( CIs ) 3.4-36 .7 % ) , as opposed to 78.5 % in the placebo group ( PG ) ( 95 % CI 48.1-115 .5 % ) , difference 63.8 % ( P = 0.0008 ) .
RESULTS	In all , 8.2 % of men in the FSG and 27.7 % in the PG opted to leave surveillance at the end of the intervention ( 2 P = 0.014 ) .
RESULTS	There were no significant differences within the predetermined subgroups of age , Gleason grade , treatment category or body mass index .
RESULTS	There were no differences in cholesterol , blood pressure , blood sugar , C-reactive protein or adverse events .
CONCLUSIONS	This study found a significant short-term , favourable effect on the percentage rise in PSA in men managed with AS and WW following ingestion of this well-tolerated , specific blend of concentrated foods .
CONCLUSIONS	Its influence on decision-making suggests that this intervention is clinically meaningful , but further trials will evaluate longer term clinical effects , and other makers of disease progression .

###24432670
OBJECTIVE	To evaluate the efficacy and safety of PMC therapy ( Prednisone , Methotrexate , Chloroquine ) combined Langchuang Fuzheng Jiedu Capsule ( LFJC ) , thus choosing a better therapy of integrative medicine for SLE in the period of glucocorticoid use .
METHODS	Sixty active SLE patients were randomly assigned to two groups , the control group and the treatment group .
METHODS	Those in the control group received PMC therapy ( As for Prednisone , it was given at the daily dose of 1 mg/kg till 2 weeks after the condition being stable or after 8 weeks of treatment .
METHODS	Then the dose was reduced by 10 % every two weeks .
METHODS	When the dose was reduced to 0.5 mg/kg daily , it was reduced by 2.5 mg per two weeks .
METHODS	When the dose was reduced to 15 mg daily , the dose was reduced to 2.5 mg per four weeks .
METHODS	As for Methotrexate , 10 mg each time , once a week .
METHODS	As for Chloroquine , 100 mg each time , twice daily ) , while those in the treatment group received PMC therapy ( the same way as that for the control group ) combined with LFJC ( consisting of Astragalus membranaceus 50 g , Angelica sinensis 20 g , Ligusticum Chuanxiong 20 g , prepared Rehmannia Rhizome 30 g , Herba Serissae 30 g , Centella 30 g , centipede 4 g , scorpions 10 g , nidus versace 12 g , et al. , 0.5 g per pill , containing 5.7 g crude drug .
METHODS	When the hormone was given at a large dose , LFJC was administered at 12 pills each time , three times daily ) .
METHODS	When the hormone was given at a middle dose , LFJC was administered at 8 pills each time , three times daily .
METHODS	When the hormone was given at a small dose , LFJC was administered at 6 pills each time , three times daily .
METHODS	The treatment course was six months .
METHODS	The improvement of symptoms and signs between before and after treatment , SLE disease activity index ( SLEDAI ) , efficacy of Chinese medical syndrome , UPro quantitation , erythrocyte sedimentation rate ( ESR ) , complement 3 ( C3 ) , C-reactive protein ( CRP ) , the reduction and withdrawal of hormones , and infection of the respiratory tract were observed .
RESULTS	The difference in post-SLEDAI was obviously larger in the treatment group than in the control group ( P < 0.05 ) .
RESULTS	The fatigue severity scale ( FSS ) was less after treatment than before treatment in the treatment group , showing statistical difference when compared with that of the control group ( P < 0.05 ) .
RESULTS	The total effective rate was 93.33 % in the treatment group , showing statistical difference when compared with that of the control group ( 86.66 % ; chi2 = 6.736 , P < 0.05 ) .
RESULTS	The ESR decreased after treatment in the treatment group , showing statistical difference when compared with that of the control group ( P < 0.01 ) .
RESULTS	C3 increased after treatment in the treatment group , showing statistical difference when compared with that of the control group ( P < 0.05 ) .
RESULTS	The hormone was reduced to ( 13.70 + / - 5.42 ) mg/d by the end of the therapeutic course in the treatment group , obviously less than that of the control group [ ( 17.63 + / - 7.80 ) mg/d , P < 0.05 ) .
RESULTS	Seven patients suffered from secondary infection of the respiratory tract infection in the treatment group ( 5 from upper respiratory tract infection and 2 from lower respiratory tract infection ) , obviously less than those of the control group ( 25 from upper respiratory tract infection and 10 from lower respiratory tract infection ) ( P < 0.05 ) .
CONCLUSIONS	PMC combined LFJC was a better treatment program for severe active SLE ( SLEDAI > or = 15 ) .
CONCLUSIONS	It was more safe and effective when compared with using Western medicine alone .
CONCLUSIONS	It could enhance the efficacy of hormones and help reduction/withdrawal of hormones .

###25269598
BACKGROUND	Infections occur in 30 % of stroke patients and are associated with unfavorable outcomes .
BACKGROUND	Preventive antibiotic therapy lowers the infection rate after stroke , but the effect of preventive antibiotic treatment on functional outcome in patients with stroke is unknown .
BACKGROUND	The PASS is a multicenter , prospective , phase three , randomized , open-label , blinded end-point ( PROBE ) trial of preventive antibiotic therapy in acute stroke .
BACKGROUND	Patients are randomly assigned to either ceftriaxone at a dose of 2 g , given every 24 h intravenously for 4 days , in addition to standard stroke-unit care , or standard stroke-unit care without preventive antibiotic therapy .
BACKGROUND	The aim of this study is to assess whether preventive antibiotic treatment improves functional outcome at 3 months by preventing infections .
BACKGROUND	This paper presents in detail the statistical analysis plan ( SAP ) of the Preventive Antibiotics in Stroke Study ( PASS ) and was submitted while the investigators were still blinded for all outcomes .
RESULTS	The primary outcome is the score on the modified Rankin Scale ( mRS ) , assessed by ordinal logistic regression analysis according to a proportional odds model .
RESULTS	Secondary analysis of the primary outcome is the score on the mRS dichotomized as a favorable outcome ( mRS 0 to 2 ) versus unfavorable outcome ( mRS 3 to 6 ) .
RESULTS	Secondary outcome measures are death rate at discharge and 3 months , infection rate during hospital admission , length of hospital admission , volume of post-stroke care , use of antibiotics during hospital stay , quality-adjusted life years and costs .
RESULTS	Complications of treatment , serious adverse events ( SAEs ) and suspected unexpected serious adverse reactions ( SUSARs ) are reported as safety outcomes .
CONCLUSIONS	The data from PASS will establish whether preventive antibiotic therapy in acute stroke improves functional outcome by preventing infection and will be analyzed according to this pre-specified SAP .
BACKGROUND	Current controlled trials ; ISRCTN66140176 .
BACKGROUND	Date of registration : 6 April 2010 .

###24568949
BACKGROUND	Chronic uncomplicated musculoskeletal pain in the spine ( cervical , thoracic or lumbar ) is highly prevalent and may severely limit the daily activities of those affected by it .
OBJECTIVE	To evaluate the efficacy and safety of treatment with auriculopressure applied to patients with non-specific spinal pain .
METHODS	A multicentre randomised controlled trial with two parallel arms ( true auriculopressure ( TAP ) and placebo auriculopressure ( PAP ) ) was performed .
METHODS	The intervention phase lasted 8weeks and outcomes were measured 1week after the last intervention ( T1 ) and 6months after baseline ( T2 ) .
METHODS	The primary outcome measure was change in pain intensity according to a 100mm visual analogue scale ( pain VAS ) at T1 .
METHODS	Secondary outcome measures were the Lattinen index , the McGill Pain Questionnaire and the SF-12 health-related quality of life scale ( Spanish version in every case ) .
RESULTS	There were 265 participants ( TAP group , n = 130 ; PAP group , n = 135 ) .
RESULTS	Pain was most frequently located in the upper back ( 55.1 % , n = 146 ) , followed by the lower back ( 25.3 % , n = 67 ) and the dorsal area ( 12.5 % , n = 33 ) .
RESULTS	Nineteen patients ( 7.2 % ) reported pain affecting the entire spine .
RESULTS	There were statistically significant differences between TAP and PAP in the change in the pain VAS at T1 of 10mm ( 95 % CI 2.8 to 17.3 , p = 0.007 ) and in the change in the pain VAS at T2 of 7.2 mm ( 95 % CI 0.02 to 14.3 , p = 0.049 ) in favour of TAP .
RESULTS	We also observed a statistically significant difference of 3.4 points in the physical component of the SF-12 in favour of TAP at T2 ( 95 % CI 0.45 to 6.3 , p = 0.024 ) .
RESULTS	No severe adverse effects were detected or reported during treatment .
CONCLUSIONS	The application of auriculopressure in patients with non-specific spinal pain in primary healthcare is effective and safe , and therefore should be considered for inclusion in the portfolio of primary healthcare services .
BACKGROUND	ISRCTN01897462 .

###24269085
OBJECTIVE	To compare changes in intraocular pressure ( IOP ) immediately after clear corneal incision ( CCI ) cataract surgery between eyes in which IOP was adjusted to a high or normal range at the conclusion of surgery .
METHODS	Hayashi Eye Hospital , Fukuoka , Japan .
METHODS	Comparative case series .
METHODS	Either eye of patients scheduled for phacoemulsification was randomized to 1 of 2 groups as follows : eyes that were to be adjusted to ( 1 ) high IOP ( 22 to 40 mm Hg ) or ( 2 ) normal IOP ( 10 to 21 mm Hg ) .
METHODS	The IOP was measured using a rebound tonometer preoperatively ; at the conclusion of surgery ; and 15 , 30 , 60 , 120 , and 180 minutes and 24 hours postoperatively .
METHODS	The Seidel test and anterior segment optical coherence tomography ( AS-OCT ) were performed .
RESULTS	The mean IOP at the conclusion of surgery was 31.3 mm Hg in the high IOP group and 17.1 mm Hg in the normal IOP group .
RESULTS	The IOP decreased to approximately 15 mm Hg by 15 minutes and did not change until 60 minutes in either group .
RESULTS	The mean IOP did not differ significantly between groups throughout the observation period ( P .0634 ) .
RESULTS	Hypotony of 5 mm Hg or less was not detected in any eye .
RESULTS	The Seidel test was negative and based on AS-OCT , the wound was closed at 60 minutes in all eyes .
CONCLUSIONS	After adjusting IOP to a high or normal range , the IOP normalized within 15 minutes postoperatively and was stable for 24 hours .
CONCLUSIONS	The wound was closed within 60 minutes postoperatively .

###25123116
BACKGROUND	Bacillus Calmette-Gurin ( BCG ) is considered the most effective treatment to reduce recurrence and progression of non-muscle invasive bladder cancer ( NMIBC ) but can induce local side effects leading to treatment discontinuation or interruption .
BACKGROUND	Aim of this exploratory study is to investigate if the sequential administration of Hyaluronic acid ( HA ) may reduce local side effects of BCG .
METHODS	30 consecutive subjects undergoing BCG intravesical administration for high risk NMIBC were randomized to receive BCG only ( Group A ) or BCG and HA ( Group B ) .
METHODS	A 1 to 10 Visual Analog Scale ( VAS ) for bladder pain , International Prostate Symptom Score ( IPSS ) and number of micturitions per day were evaluated in the two groups before and after six weekly BCG instillations .
METHODS	Patients were also evaluated at 3 and 6 months by means of cystostopy and urine cytology .
RESULTS	One out of 30 ( 3,3 % ) patients in group A dropped out from the protocol , for local side effects .
RESULTS	Mean VAS for pain was significantly lower in group B after BCG treatment ( 4.2 vs. 5.8 , p = 0.04 ) .
RESULTS	Post vs. pre treatment differences in VAS for pain , IPSS and number of daily micturitions were all significantly lower in group B. Three patients in group A and 4 in group B presented with recurrent pathology at 6 month follow up .
CONCLUSIONS	These preliminary data suggest a possible role of HA in reducing BCG local side effects and could be used to design larger randomized controlled trials , assessing safety and efficacy of sequential BCG and HA administration .
BACKGROUND	NCT02207608 ( ClinicalTrials.gov ) 01/08/2014 .
BACKGROUND	Policlinico Tor Vergata Ethics Committee , resolution n 69-2011 .

###25332249
OBJECTIVE	Positive interim analysis findings from four large adjuvant trials evaluating trastuzumab in patients with early-stage human epidermal growth factor receptor 2 ( HER2 ) - positive breast cancer were first reported in 2005 .
OBJECTIVE	One of these reports , the joint analysis of North Central Cancer Treatment Group NCCTG N9831 ( Combination Chemotherapy With or Without Trastuzumab in Treating Women With HER2-Overexpressing Breast Cancer ) and the National Surgical Adjuvant Breast and Bowel Project NSABP B-31 ( Doxorubicin and Cyclophosphamide Plus Paclitaxel With or Without Trastuzumab in Treating Women With Node-Positive Breast Cancer That Overexpresses HER2 ) , was updated in 2011 .
OBJECTIVE	We now report the planned definitive overall survival ( OS ) results from this joint analysis along with updates on the disease-free survival ( DFS ) end point .
METHODS	In all , 4,046 patients with HER2-positive operable breast cancer were enrolled to receive doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab in both trials .
METHODS	The required number of events for the definitive statistical analysis for OS ( 710 events ) was reached in September 2012 .
METHODS	Updated analyses of overall DFS and related subgroups were also performed .
RESULTS	Median time on study was 8.4 years .
RESULTS	Adding trastuzumab to chemotherapy led to a 37 % relative improvement in OS ( hazard ratio [ HR ] , 0.63 ; 95 % CI , 0.54 to 0.73 ; P < .001 ) and an increase in 10-year OS rate from 75.2 % to 84 % .
RESULTS	These results were accompanied by an improvement in DFS of 40 % ( HR , 0.60 ; 95 % CI , 0.53 to 0.68 ; P < .001 ) and increase in 10-year DFS rate from 62.2 % to 73.7 % .
RESULTS	All patient subgroups benefited from addition of this targeted anti-HER2 agent .
CONCLUSIONS	The addition of trastuzumab to paclitaxel after doxorubicin and cyclophosphamide in early-stage HER2-positive breast cancer results in a substantial and durable improvement in survival as a result of a sustained marked reduction in cancer recurrence .

###25156886
BACKGROUND	Optimal therapy for children and adolescents with advanced stage anaplastic large cell lymphoma ( ALCL ) is unknown .
BACKGROUND	ANHL0131 examined whether a maintenance regimen including vinblastine compared to the standard APO ( doxorubicin , prednisone , vincristine , methotrexate , 6-mercaptopurine ) regimen would result in superior event-free survival .
METHODS	One hundred and twenty five eligible patients were enrolled .
METHODS	Induction was identical for both arms .
METHODS	Post induction patients were randomized to receive APO with vincristine every 3 weeks or a regimen that substituted vincristine with weekly vinblastine ( APV ) .
RESULTS	There was no difference between the patients randomized to the APO versus APV arms in either event free survival ( EFS ) or overall survival ( OS ) ( three year EFS 74 % vs. 79 % , P = 0.68 and three years OS of 84 % vs. 86 % , P = 0.87 , respectively ) .
RESULTS	Patients in the APV arm required dose reduction secondary to myelosuppression and had a higher incidence of neutropenia as well as infection with neutropenia compared to those in the APO arm ( P < 0.001 , P = 0.019 , respectively ) .
CONCLUSIONS	Treatment with weekly vinblastine instead of every three week vincristine as part of multi-agent maintenance therapy did not result in improvement in EFS or OS .
CONCLUSIONS	Weekly vinblastine was associated with increased toxicity .
CONCLUSIONS	( ClinicalTrials.gov Identifier NCT00059839 ) .

###24506405
BACKGROUND	Multiple sclerosis ( MS ) treatment options are primarily limited to immunomodulatory therapies in MS non-progressive forms .
BACKGROUND	Nutrition intervention studies suggest that diet may be considered as a complementary treatment to control disease progression .
BACKGROUND	Therefore , dietary intervention may help to improve wellness and ameliorate symptoms of MS patients .
OBJECTIVE	To assess the effect of a low-fat diet with antioxidant supplementation on biochemical markers of institutionalized patients with progressive forms of multiple sclerosis .
METHODS	A randomized prospective placebo-controlled study involving 9 participants , 5 of them assigned to the intervention group ( low-fat diet and antioxidant supplementation ) and the other 4 to the placebo group ( low-fat diet ) .
METHODS	The effect of the dietary intervention , involving diet modification and antioxidant supplementation , was examined for 42 days by measuring anthropometric , biochemical parameters and oxidative stress markers in blood at baseline ( day 0 ) , intermediate ( day 15 ) and end ( day 42 ) stages of the treatment .
RESULTS	The intervention group obtained C reactive protein levels significantly lower than those observed in the corresponding placebo group at the end of the study .
RESULTS	Oxidative stress and inflammatory markers isoprostane 8-iso-PGF2 and interleukine IL-6 values also diminished after dietary intervention in the intervention group .
RESULTS	Catalase activity increased significantly in the intervention group prior antioxidant supplementation .
RESULTS	No significant differences were observed in other oxidative stress markers .
CONCLUSIONS	The results suggest that diet and dietary supplements are involved in cell metabolism modulation and MS-related inflammatory processes .
CONCLUSIONS	Consequently , low fat diets and antioxidant supplements may be used as complementary therapies for treatment of multiple sclerosis .

###24535359
OBJECTIVE	To compare the effects between dezocine and flurbiprofen axetil on postoperative sore throat ( POST ) after maxillofacial procedures .
METHODS	In the study , 90 adult patients with maxillofacial diseases were divided randomly into control group ( group C ) , flurbiprofen group ( group F ) and dezocine group ( group D ) .
METHODS	Physiological saline , flurbiprofen axetil ( 1 mg/kg ) and dezocine ( 0.1 mg/kg ) were administered intravenously for each group 30 minutes before the end of the operation .
METHODS	We recorded visual analogue scale ( VAS ) and Bruggrmann comfort scale ( BCS ) at the time points of 0.5 h , 1 h , 2 h , and 6 h after extubation .
RESULTS	The incidence of POST in group D decreased significantly ( P < 0.05 ) .
RESULTS	There was no difference between the incidences of groups F and C.
RESULTS	The VAS of group F was lower than that of group C ( P < 0.01 ) just at the time points of 0.5 h and 1 h after extubation , from then on , there was no difference between the 2 groups .
RESULTS	The VAS of group D was lower than that of group F , and the BCS was higher than that of group F significantly .
CONCLUSIONS	Dezocine has notable analgesia effect for postoperative sore throat , so it is a better choice to carry out postoperative analgesia after maxillofacial procedures .

###25082832
BACKGROUND	Only a few studies have provided information on awareness , use , and harm perceptions of e-cigarettes in Europe .
BACKGROUND	We fill the knowledge gap in Italy .
METHODS	We used data from a face-to-face survey conducted in 2013 of a sample of 3,000 individuals , representative of the Italian population aged 15 years ( 51.1 million inhabitants ) .
RESULTS	Awareness of e-cigarettes was 91.1 % ; it was lowest among women ( 87.8 % ) , the elderly ( 78.4 % ) , those with less education ( 84.1 % ) , and never-smokers ( 89.0 % ) .
RESULTS	Ever e-cigarette use was 6.8 % overall and was inversely related to age , whereas no significant difference was observed according to sex .
RESULTS	With regard to smoking status , 2.6 % of never-smokers , 7.0 % of ex-smokers , and 20.4 % of current smokers tried the e-cigarette at least once .
RESULTS	Regular e-cigarette use was 1.2 % overall , 1.5 % among men , and 0.9 % among women , and it was highest among young ( 2.4 % ) and current smokers ( 3.7 % ) .
RESULTS	Among 36 e-cigarette regular users , 22.0 % did not change their smoking habit , 67.7 % reduced traditional cigarette consumption , and 10.4 % quit smoking .
CONCLUSIONS	After fewer than 3 years from the opening of the first Italian e-cigarette shop , more than 45 million Italians have heard about e-cigarettes , 3.5 million have tried e-cigaretts , and more than 600,000 Italians regularly use e-cigarettes .
CONCLUSIONS	Three out of 4 e-cigarette users reported to have favorably modified their smoking habit ; however , 90 % of users did not quit smoking as a consequence of starting vaping e-cigarettes .
CONCLUSIONS	Almost 900,000 Italian never-smokers , particularly young never-smokers , have tried this new and potentially addictive product at least once .

###25833773
BACKGROUND	It has been suggested that perturbations in branched-chain amino acid ( BCAA ) catabolism are associated with insulin resistance and contribute to elevated systemic BCAAs .
BACKGROUND	Evidence in rodents suggests dietary protein rich in BCAAs can increase BCAA catabolism , but there is limited evidence in humans .
OBJECTIVE	We hypothesize that a diet rich in BCAAs will increase BCAA catabolism , which will manifest in a reduction of fasting plasma BCAA concentrations .
METHODS	The metabolome of 27 obese women with metabolic syndrome before and after weight loss was investigated to identify changes in BCAA metabolism using GC-time-of-flight mass spectrometry .
METHODS	Subjects were enrolled in an 8-wk weight-loss study including either a 20-g/d whey ( whey group , n = 16 ) or gelatin ( gelatin group , n = 11 ) protein supplement .
METHODS	When matched for total protein by weight , whey protein has 3 times the amount of BCAAs compared with gelatin protein .
RESULTS	Postintervention plasma abundances of Ile ( gelatin group : 637 18 , quantifier ion peak height 100 ; whey group : 744 65 ) , Leu ( gelatin group : 1210 33 ; whey group : 1380 79 ) , and Val ( gelatin group : 2080 59 ; whey group : 2510 230 ) did not differ between treatment groups .
RESULTS	BCAAs were significantly correlated with homeostasis model assessment of insulin resistance at baseline ( r = 0.52 , 0.43 , and 0.49 for Leu , Ile , and Val , respectively ; all , P < 0.05 ) , but correlations were no longer significant at postintervention .
RESULTS	Pro- and Cys-related pathways were found discriminant of whey protein vs. gelatin protein supplementation in multivariate statistical analyses .
CONCLUSIONS	These findings suggest that BCAA metabolism is , at best , only modestly affected at a whey protein supplementation dose of 20 g/d .
CONCLUSIONS	Furthermore , the loss of an association between postintervention BCAA and homeostasis model assessment suggests that factors associated with calorie restriction or protein intake affect how plasma BCAAs relate to insulin sensitivity .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT00739479 .

###24506231
OBJECTIVE	The aim was to study a client-centred activities of daily living ( ADL ) intervention ( CADL ) compared with the usual ADL intervention ( UADL ) in people with stroke regarding : independence in ADL , perceived participation , life satisfaction , use of home-help service , and satisfaction with training and , in their significant others , regarding : caregiver burden , life satisfaction , and informal care .
METHODS	In this multicentre study , 16 rehabilitation units were randomly assigned to deliver CADL or UADL .
METHODS	The occupational therapists who provided the CADL were specifically trained .
METHODS	Eligible for inclusion were people with stroke treated in a stroke unit 3 months after stroke , dependent in two ADL , not diagnosed with dementia , and able to understand instructions .
METHODS	Data were collected at inclusion and three months thereafter .
METHODS	To detect a significant difference between the groups in the Stroke Impact Scale ( SIS ) domain `` participation '' , 280 participants were required .
METHODS	Intention-to-treat analysis was applied .
RESULTS	At three months , there was no difference in the outcomes between the CADL group ( n = 129 ) and the UADL group ( n = 151 ) , or their significant others ( n = 87/n = 93 ) except in the SIS domain `` emotion '' in favour of CADL ( p = 0.04 ) .
CONCLUSIONS	The CADL does not appear to bring about short-term differences in outcomes and longer follow-ups are required .

###24622805
BACKGROUND	Early nutrition is recognized as a target for the effective prevention of childhood obesity .
BACKGROUND	Protein intake was associated with more rapid weight gain during infancy-a known risk factor for later obesity .
OBJECTIVE	We tested whether the reduction of protein in infant formula reduces body mass index ( BMI ; in kg/m ( 2 ) ) and the prevalence of obesity at 6 y of age .
METHODS	The Childhood Obesity Project was conducted as a European multicenter , double-blind , randomized clinical trial that enrolled healthy infants born between October 2002 and July 2004 .
METHODS	Formula-fed infants ( n = 1090 ) were randomly assigned to receive higher protein ( HP ) - or lower protein ( LP ) - content formula ( within recommended amounts ) in the first year of life ; breastfed infants ( n = 588 ) were enrolled as an observational reference group .
METHODS	We measured the weight and height of 448 ( 41 % ) formula-fed children at 6 y of age .
METHODS	BMI was the primary outcome .
RESULTS	HP children had a significantly higher BMI ( by 0.51 ; 95 % CI : 0.13 , 0.90 ; P = 0.009 ) at 6 y of age .
RESULTS	The risk of becoming obese in the HP group was 2.43 ( 95 % CI : 1.12 , 5.27 ; P = 0.024 ) times that in the LP group .
RESULTS	There was a tendency for a higher weight in HP children ( 0.67 kg ; 95 % CI : -0.04 , 1.39 kg ; P = 0.064 ) but no difference in height between the intervention groups .
RESULTS	Anthropometric measurements were similar in the LP and breastfed groups .
CONCLUSIONS	Infant formula with a lower protein content reduces BMI and obesity risk at school age .
CONCLUSIONS	Avoidance of infant foods that provide excessive protein intakes could contribute to a reduction in childhood obesity .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT00338689 .

###25168125
OBJECTIVE	Effective treatment algorithms are needed to guide diabetes care at hospital discharge in general medicine and surgery patients with type 2 diabetes .
METHODS	This was a prospective , multicenter open-label study aimed to determine the safety and efficacy of a hospital discharge algorithm based on admission HbA1c .
METHODS	Patients with HbA1c < 7 % ( 53.0 mmol/mol ) were discharged on their preadmission diabetes therapy , HbA1c between 7 and 9 % ( 53.0-74 .9 mmol/mol ) were discharged on a preadmission regimen plus glargine at 50 % of hospital daily dose , and HbA1c > 9 % were discharged on oral antidiabetes agents ( OADs ) plus glargine or basal bolus regimen at 80 % of inpatient dose .
METHODS	The primary outcome was HbA1c concentration at 12 weeks after hospital discharge .
RESULTS	A total of 224 patients were discharged on OAD ( 36 % ) , combination of OAD and glargine ( 27 % ) , basal bolus ( 24 % ) , glargine alone ( 9 % ) , and diet ( 4 % ) .
RESULTS	The admission HbA1c was 8.7 2.5 % ( 71.6 mmol/mol ) and decreased to 7.3 1.5 % ( 56 mmol/mol ) at 12 weeks of follow-up ( P < 0.001 ) .
RESULTS	The change of HbA1c from baseline at 12 weeks after discharge was -0.1 0.6 , -0.8 1.0 , and -3.2 2.4 in patients with HbA1c < 7 % , 7-9 % , and > 9 % , respectively ( P < 0.001 ) .
RESULTS	Hypoglycemia ( < 70 mg/dL ) was reported in 22 % of patients discharged on OAD only , 30 % on OAD plus glargine , 44 % on basal bolus , and 25 % on glargine alone and was similar in patients with admission HbA1c 7 % ( 26 % ) compared with those with HbA1c > 7 % ( 31 % , P = 0.54 ) .
CONCLUSIONS	Measurement of HbA1c on admission is beneficial in tailoring treatment regimens at discharge in general medicine and surgery patients with type 2 diabetes .

###24834865
OBJECTIVE	The primary target cells for the human immunodeficiency virus ( HIV ) infection in the genital tract are CD4 T cells that express CCR5 on the surface .
OBJECTIVE	Alterations in genital tract T cells that express CCR5 could impact HIV acquisition risk .
OBJECTIVE	We hypothesized that , when compared with baseline , the use of a hormonal intrauterine device ( IUD ) would alter HIV target cells ( primarily CCR5 + CD4 cells ) in the female genital tract more than a nonhormonal IUD .
METHODS	Thirty-four healthy HIV-negative women aged 18-40 years who were seeking an IUD for contraception were assigned randomly to receive a levonorgestrel IUD or a copper T380A IUD .
METHODS	A parallel group of 8 control women who did not need contraception was also enrolled .
METHODS	Genital tract mucosal immune cell populations that were collected by cervical cytobrush and endometrial biopsy before and 2 months after IUD placement were analyzed by flow cytometry .
METHODS	Mean differences in cell number and percent that expressed receptors from baseline to follow-up examination were evaluated with the use of paired Student t tests .
RESULTS	Neither IUD altered the number of T cells within the upper and lower genital tracts .
RESULTS	Levonorgestrel IUD users had a decrease in T cells that expressed the HIV coreceptor CCR5 in the endometrium and cervix after 2 months of use compared with baseline .
RESULTS	There was a decrease in activated endometrial T cells in levonorgestrel IUD users and a decrease in activated cervical T cells in copper IUD users after 2 months of IUD use , compared with baseline .
CONCLUSIONS	Women who use IUDs have reduced expression of the CCR5 HIV coreceptor on T cells in the endometrium and cervix compared with expression before IUD placement .
CONCLUSIONS	These findings suggest that susceptibility to HIV infection would not be increased by IUD use .

###25045857
OBJECTIVE	To investigate the hospital cost and short-term clinical outcome of traditional minimally invasive hysterectomy vs robot-assisted hysterectomy in women primarily not considered candidates for vaginal surgery .
METHODS	Randomized controlled trial ( Canadian Task Force classification I ) .
METHODS	University Hospital in Sweden .
METHODS	One hundred twenty-two women with uterine size 16 gestational weeks scheduled to undergo minimally invasive hysterectomy because of benign disease .
METHODS	Robot-assisted hysterectomy or traditional vaginal or laparoscopic minimally invasive hysterectomy .
RESULTS	All women underwent surgery as randomized .
RESULTS	There were no demographic differences between the 2 groups .
RESULTS	Vaginal hysterectomy was possible in 41 % in the traditional minimally invasive group , at a mean hospital cost of $ 4579 compared with $ 7059 for traditional laparoscopic hysterectomy .
RESULTS	This was reflected in a mean hospital cost of $ 993 more per robotic-assisted hysterectomy than for traditional minimally invasive hysterectomy when the robot was a preexisting investment .
RESULTS	This hospital cost increased by $ 1607 when including investments and cost of maintenance .
RESULTS	A per-protocol subanalysis comparing laparoscopy and robotics demonstrated similar hospital cost when the robot was a preexisting investment ( $ 7059 vs $ 7016 ) .
RESULTS	Robotic-assisted hysterectomy was associated with less blood loss and fewer postoperative complications .
CONCLUSIONS	A similar hospital cost can be attained for laparoscopy and robotics when the robot is a preexisting investment .
CONCLUSIONS	From the perspective of hospital costs , robotic-assisted hysterectomy is not advantageous for treating benign conditions when a vaginal approach is feasible in a high proportion of patients .

###25503546
OBJECTIVE	National Institutes of Health Stroke Scale ( NIHSS ) item profiles that were recently proposed may prove useful both clinically and for research studies .
OBJECTIVE	We aimed to validate the NIHSS item profiles in an acute cohort .
METHODS	We conducted a retrospective analysis on pooled data from randomized clinical trials .
METHODS	We applied the latent class analysis probabilities of profile membership developed from the derivation study to obtain symptom grouping , a-NIHSS item profiles .
METHODS	We implemented an independent latent class analysis to derive secondary symptom grouping , b-NIHSS item profiles .
METHODS	Validation was performed by assessing the associations with outcomes and evaluating both sets of NIHSS item profiles ' discrimination and calibration to the data .
METHODS	The outcomes evaluated included modified Rankin Scale ( mRS ; using the full distribution and dichotomized , mRS , 0-1 ) at day 90 and mortality by 90 days .
RESULTS	We identified 10 271 patients .
RESULTS	Ordinal analysis of mRS confirmed increased odds of better outcome across the profiles in a stepwise manner , adjusted for age and thrombolysis treatment , for each set of NIHSS item profiles .
RESULTS	Similar patterns were observed for mRS 0 to 1 , and inverse patterns were seen for mortality .
RESULTS	The c-statistics of a-NIHSS and b-NIHSS item profiles for mRS 0 to 1 were similar at 0.71 ( 95 % confidence interval , 0.70-0 .72 ) and for mortality , 0.74 ( 0.73-0 .75 ) and 0.75 ( 0.73-0 .76 ) , respectively .
RESULTS	Calibration was good .
CONCLUSIONS	These NIHSS item profiles identified using latent class analysis offer a reliable approach to capture the true response patterns that are associated with functional and outcome and mortality post stroke .
CONCLUSIONS	This approach has the potential to enhance the clinical value of the overall NIHSS score .

###24481719
BACKGROUND	The current study was undertaken to investigate the efficacy and safety of erlotinib versus pemetrexed as second-line therapy for patients with advanced epidermal growth factor receptor ( EGFR ) wild-type and EGFR fluorescence in situ hybridization ( FISH ) - positive lung adenocarcinoma .
METHODS	In this open-label , randomized , phase 2 study , patients with EGFR wild-type and EGFR FISH-positive adenocarcinoma who had developed disease progression after 1 prior platinum-based chemotherapy were randomly assigned ( 1:1 ) to receive erlotinib or pemetrexed until the time of disease progression or death , unacceptable toxicity , or a request for discontinuation by the patient .
METHODS	The primary endpoint was progression-free survival ( PFS ) .
RESULTS	A total of 123 patients were enrolled ( 61 in the erlotinib arm and 62 in the pemetrexed arm ) .
RESULTS	The median PFS was 4.1 months ( 95 % confidence interval [ 95 % CI ] , 1.6 months-6 .6 months ) in the erlotinib group versus 3.9 months ( 95 % CI , 2.7 months-5 .1 months ) in the pemetrexed group .
RESULTS	The difference in PFS between the 2 treatment groups was not significant ( hazard ratio , 0.92 ; 95 % CI , 0.62-1 .37 [ P = .683 ] ) .
RESULTS	The objective response rate appeared to be higher among patients receiving erlotinib compared with those receiving pemetrexed ( 19.7 % vs 8.1 % ; P = .062 ) .
RESULTS	The 3 most commonly recorded adverse events were rash ( 54.1 % ) , fatigue ( 19.7 % ) , and diarrhea ( 16.4 % ) in the erlotinib group and fatigue ( 25.8 % ) , nausea ( 24.2 % ) , and anorexia ( 14.5 % ) in the pemetrexed group .
CONCLUSIONS	There were no significant differences noted with regard to efficacy between erlotinib and pemetrexed in the second-line setting for patients with advanced EGFR wild-type and EGFR FISH-positive lung adenocarcinoma .
CONCLUSIONS	Both regimens appear to be effective treatment options for these patients .

###25294746
OBJECTIVE	To examine the impact of a weight loss intervention upon follicle stimulating hormone ( FSH ) levels in postmenopause .
METHODS	Participants were postmenopausal , overweight , glucose-intolerant women not using exogenous estrogen ( n = 382 ) in the Diabetes Prevention Program .
METHODS	Women were randomized to intensive lifestyle change ( ILS ) with the goals of weight reduction of at least 7 % of initial weight and 150 min per week of moderate-intensity exercise , metformin 850 mg twice a day , or placebo administered twice a day .
RESULTS	Randomization to ILS led to small increases in FSH between baseline and 1-year follow-up vs. placebo ( 2.3 IU/l vs. -0.81 IU/l , P < 0.01 ) .
RESULTS	Increases in FSH were correlated with decreases in weight ( r = -0.165 , P < 0.01 ) and estradiol ( E2 ) ( r = -0.464 , P < 0.0001 ) after adjustment for age , race/ethnicity , and randomization arm .
RESULTS	Changes in FSH were still significantly associated with changes in weight even after adjustment for E2 levels .
RESULTS	Metformin users had reductions in weight but non-significant changes in FSH and E2 levels vs. placebo .
CONCLUSIONS	Weight loss leads to small increases in FSH among overweight , postmenopausal women , potentially through pathways mediated by endogenous estrogen as well as other pathways .

###25811395
BACKGROUND	Low levels of physical activity ( PA ) are associated with poor outcomes in people with COPD .
BACKGROUND	Interventions to increase PA could improve outcomes .
METHODS	We tested the efficacy of a novel Internet-mediated , pedometer-based exercise intervention .
METHODS	Veterans with COPD ( N = 239 ) were randomized in a 2:1 ratio to the ( 1 ) intervention group ( Omron HJ-720 ITC pedometer and Internet-mediated program ) or ( 2 ) wait-list control group ( pedometer ) .
METHODS	The primary outcome was health-related quality of life ( HRQL ) , assessed by the St. George 's Respiratory Questionnaire ( SGRQ ) , at 4 months .
METHODS	We examined the SGRQ total score ( SGRQ-TS ) and three domain scores : Symptoms , Activities , and Impact .
METHODS	The secondary outcome was daily step counts .
METHODS	Linear regression models assessed the effect of intervention on outcomes .
RESULTS	Participants had a mean age of 67 9 years , and 94 % were men .
RESULTS	There was no significant between-group difference in mean 4-month SGRQ-TS ( 2.3 units , P = .14 ) .
RESULTS	Nevertheless , a significantly greater proportion of intervention participants than control subjects had at least a 4-unit improvement in SGRQ-TS , the minimum clinically important difference ( 53 % vs 39 % , respectively , P = .05 ) .
RESULTS	For domain scores , the intervention group had a lower ( reflecting better HRQL ) mean than the control group by 4.6 units for Symptoms ( P = .046 ) and by 3.3 units for Impact ( P = .049 ) .
RESULTS	There was no significant difference in Activities score between the two groups .
RESULTS	Compared with the control subjects , intervention participants walked 779 more steps per day at 4 months ( P = .005 ) .
CONCLUSIONS	An Internet-mediated , pedometer-based walking program can improve domains of HRQL and daily step counts at 4 months in people with COPD .
BACKGROUND	Clinical Trials.gov ; No. : NCT01102777 ; URL : www.clinicaltrials.gov .

###24417410
OBJECTIVE	To determine the effects of cognitive training on cognitive abilities and everyday function over 10 years .
METHODS	Ten-year follow-up of a randomized , controlled single-blind trial ( Advanced Cognitive Training for Independent and Vital Elderly ( ACTIVE ) ) with three intervention groups and a no-contact control group .
METHODS	Six U.S. cities .
METHODS	A volunteer sample of 2,832 persons ( mean baseline age 73.6 ; 26 % African American ) living independently .
METHODS	Ten training sessions for memory , reasoning , or speed of processing ; four sessions of booster training 11 and 35 months after initial training .
METHODS	Objectively measured cognitive abilities and self-reported and performance-based measures of everyday function .
RESULTS	Participants in each intervention group reported less difficulty with instrumental activities of daily living ( IADLs ) ( memory : effect size = 0.48 , 99 % confidence interval ( CI ) = 0.12-0 .84 ; reasoning : effect size = 0.38 , 99 % CI = 0.02-0 .74 ; speed of processing : effect size = 0.36 , 99 % CI = 0.01-0 .72 ) .
RESULTS	At a mean age of 82 , approximately 60 % of trained participants , versus 50 % of controls ( P < .05 ) , were at or above their baseline level of self-reported IADL function at 10 years .
RESULTS	The reasoning and speed-of-processing interventions maintained their effects on their targeted cognitive abilities at 10 years ( reasoning : effect size = 0.23 , 99 % CI = 0.09-0 .38 ; speed of processing : effect size = 0.66 , 99 % CI = 0.43-0 .88 ) .
RESULTS	Memory training effects were no longer maintained for memory performance .
RESULTS	Booster training produced additional and durable improvement for the reasoning intervention for reasoning performance ( effect size = 0.21 , 99 % CI = 0.01-0 .41 ) and the speed-of-processing intervention for speed-of-processing performance ( effect size = 0.62 , 99 % CI = 0.31-0 .93 ) .
CONCLUSIONS	Each Advanced Cognitive Training for Independent and Vital Elderly cognitive intervention resulted in less decline in self-reported IADL compared with the control group .
CONCLUSIONS	Reasoning and speed , but not memory , training resulted in improved targeted cognitive abilities for 10 years .

###24988121
OBJECTIVE	Attention deficits are often among the most persistent and debilitating impairments resulting from traumatic brain injury ( TBI ) .
OBJECTIVE	This study examined the effects of lisdexamfetamine dimesylate ( Vyvanse ) in treating attention deficits due to moderate-to-severe TBI .
OBJECTIVE	It was the first study of lisdexamfetamine dimesylate with this population and , in fact , was the first controlled trial in this area examining a stimulant medication option other than methylphenidate .
METHODS	This was a 12-week , randomized , double-blind , placebo-controlled , cross-over trial .
METHODS	A total of 22 rigorously selected cases were enrolled , 13 of whom completed the trial .
METHODS	They were 16-42 years of age and had newly acquired attention deficits persisting for 6-34 months post-injury .
METHODS	They were assessed on a broad range of neuropsychological and behavioural measures at baseline , 6-weeks and at 12-weeks .
CONCLUSIONS	Positive treatment effects were found involving selective measures of sustained attention , working memory , response speed stability and endurance and in aspects of executive functioning .
CONCLUSIONS	No major problems with safety or tolerability were observed .
CONCLUSIONS	Some moderating treatment effects were found from a broad range of pre-treatment subject characteristics and injury variables examined .
CONCLUSIONS	Avenues for further research and treatment applications in this area are discussed .

###25886894
BACKGROUND	Extended sitting time at work is viewed as a crucial public health issue .
BACKGROUND	Encouraging workers to stand during their office hours via the installation of standing desks maybe one effective option to combat this .
BACKGROUND	Here , we investigate whether the installation of high desks in the workplace can induce positive changes in the amount of physical activity ( PA ) and thereby lead to subsequent improvements in anthropometric parameters .
METHODS	Thirty-two white-collar workers ( 22 men and 10 women , mean age 44.2 ) were randomly divided into two groups .
METHODS	A randomised crossover trial was performed for 13 weeks .
METHODS	During the experimental period , subjects completed their office work in a standing position using stationary high desks ( standing work , SW ) for 10 hours per week or more ( SW period ) .
METHODS	The subjects were asked to maintain their normal sitting working habits during the control period ( CONT period ) .
METHODS	The primary outcome was PA , which was assessed objectively using a triaxial accelerometer during weekdays and weekends .
METHODS	The secondary outcomes were anthropometric measurements .
METHODS	For each group and each parameter , the mean values during each period were recorded and were compared by paired t test .
RESULTS	The daily total PA ( 10.2 2.4 vs. 9.7 2.3 METs h/day , P = 0.043 ) , MVPA ( 4.2 2.2 vs. 3.7 1.8 METs h/day , P = 0.025 ) , time spent in moderate PA ( 58.2 20.7 vs. 53.4 17.0 min/day , P = 0.019 ) and time spent in MVPA ( 62.8 25.1 vs. 57.0 20.3 min/day , P = 0.019 ) were significantly higher during the SW period compared to the CONT period .
RESULTS	A weekdays verses weekends subanalysis revealed that these parameters were significantly higher during the SW period compared to the CONT period during weekdays only .
RESULTS	No significant differences were noted before and after SW periods for most of the anthropometric measures , except waist circumference ( 83.7 7.9 vs. 83.0 7.9 cm , respectively , P = 0.007 ) .
CONCLUSIONS	Standing work , via the installation of high desks , significantly increases moderate to vigorous physical activity , especially on weekdays .
BACKGROUND	UMIN-CRT , UMIN000016731 , 7th March 2015 .

###24907147
OBJECTIVE	The aims of this study were to investigate the short-term benefit of etanercept ( ETN ) + MTX vs conventional synthetic DMARDs ( csDMARDs ; HCQ , LEF or SSZ ) + MTX in subjects with established RA .
OBJECTIVE	The effect of disease duration ( 2 years vs > 2 years ) and severity ( moderate vs severe ) on treatment outcomes was also assessed .
OBJECTIVE	Methods .
OBJECTIVE	Data from Asian and Latin American subjects with inadequate response to MTX were pooled from the APPEAL ( ETN 25 mg biweekly + MTX or csDMARD + MTX ; NCT00422227 ) and Latin RA ( ETN 50 mg/week + MTX or csDMARD + MTX ; NCT00848354 ) studies .
OBJECTIVE	Endpoints included the 28-joint DAS with ESR ( DAS28-ESR ) low disease activity ( LDA ; 3.2 ) , DAS28 remission ( < 2.6 ) and HAQ score 0.5 .
RESULTS	Four hundred seventy-eight subjects received ETN + MTX , 245 subjects received csDMARD + MTX [ HCQ + MTX ( n = 81 ) , LEF + MTX ( n = 69 ) , SSZ + MTX ( n = 95 ) ] .
RESULTS	At week 16 , significantly more subjects receiving ETN + MTX vs subjects on csDMARDs + MTX achieved DAS28-ESR LDA ( 39 % vs 18 % , P < 0.001 ) , remission ( 18 % vs 7 % , P < 0.001 ) and HAQ 0.5 ( 48 % vs 34 % , P < 0.001 ) .
RESULTS	For both treatment arms , these endpoints were achieved by a greater proportion of subjects with 2 years vs > 2 years disease duration and with moderate vs severe disease activity .
CONCLUSIONS	Overall , ETN + MTX was more effective in treating subjects with established RA than csDMARDs + MTX at 16 weeks .
CONCLUSIONS	More subjects with shorter disease duration and moderate disease activity achieved optimal response regardless of treatment regimen .
BACKGROUND	clinicaltrials.gov , NCT00422227 and NCT00848354 .

###25201722
BACKGROUND	The National Emphysema Treatment Trial ( NETT ) was a randomized clinical trial designed to compare lung volume reduction surgery ( LVRS ) with maximal medical care for patients with severe emphysema .
BACKGROUND	The trial was halted early for a subgroup of patients with severe lung disease .
BACKGROUND	We report longer term follow-up for this high-risk subgroup .
METHODS	In a randomized clinical trial , patients with moderate to severe emphysema were assigned to LVRS plus maximal medical care or to maximal medical care alone and followed prospectively for vital status over 15 years .
METHODS	We focus on 140 high-risk patients .
METHODS	Quality of life data were available through 6 years of follow-up and were assessed using the University of California , San Diego Shortness of Breath Questionnaire and the Self-Administered Quality of Well-Being Scale .
RESULTS	Through the first 3 years of follow-up , surgical patients in the high-risk subgroup had a significantly higher probability of death .
RESULTS	However , the mortality curves crossed and there was a trend favoring surgical treatment through the remainder of the follow-up .
RESULTS	The log-rank test suggested that the 2 groups were not significantly different ( p = 0.95 ) in survival .
RESULTS	Quality of life data suggested an advantage of LVRS through the first 5 years of follow-up ( p < 0.01 ) .
RESULTS	The combined quality-adjusted survival model favored the medical group for the first few years of follow-up and favored the LVRS group after 4 years .
CONCLUSIONS	The NETT was stopped early for high-risk patients with severe lung disease .
CONCLUSIONS	Longer term follow-up suggests that surgical patients in this high-risk subgroup ultimately achieved comparable outcomes .
CONCLUSIONS	The high risk of death within 30 days of the surgery may discourage use of the procedure for high-risk patients despite the potential for better long-term outcomes .

###24522442
BACKGROUND	Docosahexaenoic acid ( DHA ) accumulates in the hippocampus and frontal lobes of the fetal brain during the last trimester of pregnancy .
BACKGROUND	These areas of the brain contribute to attention and working memory and inhibitory control ( WMIC ) .
OBJECTIVE	We evaluated the effect of maternal omega-3 ( n-3 ) long-chain polyunsaturated fatty acid supplementation in pregnancy on child attention and WMIC .
METHODS	A total of 185 term-born children of mothers who were randomly allocated to consume 800 mg DHA/d ( treatment ) or a placebo ( control ) from 20 wk of gestation until birth were assessed with multiple measures of attention and WMIC at a mean ( SD ) of 27 2 mo. .
METHODS	Primary outcomes were the average time it took to be distracted when playing with a toy ( distractibility ) and the accuracy of remembering a new hiding location while inhibiting a learned response to search in the previous location ( WMIC ) .
RESULTS	Assessments were completed by 81 children in the treatment group ( mean SD age : 835 50.4 d ) and 77 children in the control group ( 839 65.6 d ) .
RESULTS	There was no effect of supplementation on primary outcomes [ distractibility mean difference : -0.2 s ( 95 % CI : -0.7 , 0.4 s ) ; WMIC mean difference : 8.9 mm ( 95 % CI : -10.6 , 28.3 mm ) ] .
RESULTS	There was no difference between DHA-supplemented and control groups except that treatment-group children looked away from the toys fewer times than controls when presented with multiple toys competing for attention but less accurately remembered a repeated hiding location .
RESULTS	These secondary effects were not consistent with any other outcomes and may have been a result of chance .
RESULTS	Cord plasma DHA was not consistently associated with attention and WMIC .
CONCLUSIONS	Maternal DHA supplementation during pregnancy does not enhance attention or WMIC in term-born preschoolers .
CONCLUSIONS	The DHA for Maternal and Infant Outcomes trial was registered at www.anzctr.org.au as ACTRN1260500056906 .

###25988461
OBJECTIVE	Oral steroids are commonly used to treat acute sciatica due to a herniated disk but have not been evaluated in an appropriately powered clinical trial .
OBJECTIVE	To determine if oral prednisone is more effective than placebo in improving function and pain among patients with acute sciatica .
METHODS	Randomized , double-blind , placebo-controlled clinical trial conducted from 2008 to 2013 in a large integrated health care delivery system in Northern California .
METHODS	Adults ( n = 269 ) with radicular pain for 3 months or less , an Oswestry Disability Index ( ODI ) score of 30 or higher ( range , 0-100 ; higher scores indicate greater dysfunction ) , and a herniated disk confirmed by magnetic resonance imaging were eligible .
METHODS	Participants were randomly assigned in a 2:1 ratio to receive a tapering 15-day course of oral prednisone ( 5 days each of 60 mg , 40 mg , and 20 mg ; total cumulative dose = 600 mg ; n = 181 ) or matching placebo ( n = 88 ) .
METHODS	The primary outcome was ODI change at 3 weeks ; secondary outcomes were ODI change at 1 year , change in lower extremity pain ( measured on a 0-10 scale ; higher scores indicate more pain ) , spine surgery , and Short Form 36 Health Survey ( SF-36 ) Physical Component Summary ( PCS ) and Mental Component Summary ( MCS ) scores ( 0-100 scale ; higher scores better ) .
RESULTS	Observed baseline and 3-week mean ODI scores were 51.2 and 32.2 for the prednisone group and 51.1 and 37.5 for the placebo group , respectively .
RESULTS	The prednisone-treated group showed an adjusted mean 6.4-point ( 95 % CI , 1.9-10 .9 ; P = .006 ) greater improvement in ODI scores at 3 weeks than the placebo group and a mean 7.4-point ( 95 % CI , 2.2-12 .5 ; P = .005 ) greater improvement at 52 weeks .
RESULTS	Compared with the placebo group , the prednisone group showed an adjusted mean 0.3-point ( 95 % CI , -0.4 to 1.0 ; P = .34 ) greater reduction in pain at 3 weeks and a mean 0.6-point ( 95 % CI , -0.2 to 1.3 ; P = .15 ) greater reduction at 52 weeks .
RESULTS	The prednisone group showed an adjusted mean 3.3-point ( 95 % CI , 1.3-5 .2 ; P = .001 ) greater improvement in the SF-36 PCS score at 3 weeks , no difference in the SF-36 PCS score at 52 weeks ( mean , 2.5 ; 95 % CI , -0.3 to 5.4 ; P = .08 ) , no change in the SF-36 MCS score at 3 weeks ( mean , 2.2 ; 95 % CI , -0.4 to 4.8 ; P = .10 ) , and an adjusted 3.6-point ( 95 % CI , 0.6-6 .7 ; P = .02 ) greater improvement in the SF-36 MCS score at 52 weeks .
RESULTS	There were no differences in surgery rates at 52-week follow-up .
RESULTS	Having 1 or more adverse events at 3-week follow-up was more common in the prednisone group than in the placebo group ( 49.2 % vs 23.9 % ; P < .001 ) .
CONCLUSIONS	Among patients with acute radiculopathy due to a herniated lumbar disk , a short course of oral steroids , compared with placebo , resulted in modestly improved function and no improvement in pain .
BACKGROUND	clinicaltrials.gov Identifier : NCT00668434 .

###24346384
BACKGROUND	Abdominal sepsis is associated with varied degree of hypoxemia and atelactasis in the lung and can enhance the onset of desaturation of arterial blood during apnea .
OBJECTIVE	This study looked at methods to improve safety margin of apnea during induction of anesthesia in these high-risk patients .
METHODS	It was a randomized , single blind study on adult patients presenting for emergency laparotomy due to peritonitis in a university teaching hospital setting .
METHODS	In group 1 ( IS ) ( n = 32 ) , three sessions of incentive spirometry ( IS ) were performed within one hour before induction of anesthesia .
METHODS	In group 2 ( DB ) ( n = 34 ) , patients were subjected to deep breathing sessions in a similar manner .
METHODS	All patients received preoxygenation ( 100 % ) by mask for 3 min , followed by rapid-sequence induction of anesthesia using fentanyl , thiopental , and suxamethonium and endotracheal intubation .
METHODS	Patients were subjected to a period of apnea by keeping the end of the endotracheal tube open to air till they developed 95 % hemoglobin saturation ( SpO 2 ) by pulse oxymetry .
METHODS	Positive pressure ventilation was resumed at the end .
METHODS	We observed for hemodynamic changes , apnea time , and SpO 2 ( 100 % ) recovery time on resuming ventilation .
METHODS	Arterial blood gas samples were taken before intervention , after IS or DB , after preoxygenation , and at the end of apnea .
METHODS	One-way analysis of variance ( ANOVA ) , X 2 test , Kaplan-Meier graph , and log-rank tests were applied to compare the two study groups .
RESULTS	Oxygenation level in group 1 ( 265 76.7 mmHg ) patients was significantly ( P < 0.001 ) higher than in group 2 ( 221 61.8 mmHg ) at the end of preoxygenation .
RESULTS	The apnea time ( median : lower bound - upper bound Confidence Interval apnea time ) ( 272:240 -279 s ) in group 1 ( IS ) patients was significantly higher P < 0.05 ) than in group 2 ( 180:163 -209 s ) patients .
RESULTS	Saturation recovery time ( 35:34 -46 s ) in group 1 ( IS ) patients was also quicker than in group 2 patients ( 48:44 -58 s ) .
CONCLUSIONS	IS in the preoperative period is superior to deep breathing sessions for improving apnea tolerance during induction of anesthesia in abdominal sepsis patients .

###25040945
OBJECTIVE	Amino acid ( AA ) metabolism is altered in type 2 diabetes ( T2D ) , and fasting levels of - hydroxybutyrate ( - HB ) , a biomarker for insulin resistance , have been suggested to track AA metabolism .
OBJECTIVE	We investigated the changes in AA and - HB induced by a mixed-meal tolerance test ( MTT ) and the effects of sitagliptin treatment .
METHODS	Forty-seven T2D patients [ 56 7 years , body mass index ( BMI ) 29.9 4.2 kg/m ( 2 ) ] were randomized to sitagliptin ( 100 mg/day , 6 weeks ) or placebo .
METHODS	Seven age - and BMI-matched non-diabetic subjects served as control ( CT ) .
RESULTS	During a 5-h MTT , branched-chain AA ( BCAA ) peaked earlier in T2D than CT [ 75 ( 25 ) vs. 62 ( 3 ) mmol/l h over 2 h , median ( interquartile range ) , p = 0.05 ] , and rose higher [ 5-h increment : 31 ( 23 ) vs. 19 ( 24 ) mmol/l h , p = 0.05 ] .
RESULTS	Fasting - HB was higher [ 7.5 ( 2.7 ) vs. 5.9 ( 1.3 ) g/ml , p = 0.04 T2D vs. CT ] , and its meal-induced increments were larger [ 24 ( 99 ) vs. -41 ( 86 ) g/ml h , p = 0.006 ] .
RESULTS	Plasma non-esterified fatty acids ( NEFA ) declined during MTT , but their increments were greater in patients ( 53 16 vs. 35 10 mEq/l h , p = 0.005 ) .
RESULTS	Compared to placebo , both BCAA [ -6.4 ( 21.1 ) vs. 0.0 ( 48.0 ) mmol/l h , p = 0.01 ] and - HB increments [ -114 ( 250 ) vs. 114 ( 428 ) g/ml h , p = 0.002 ] decreased with sitagliptin , and meal-induced NEFA suppression was improved .
RESULTS	Changes in BCAA and - HB were reciprocally related to changes in insulin sensitivity ( = -0.37 and -0.43 , p 0.01 ) .
CONCLUSIONS	T2D is associated with a hyperaminoacidaemic response to MTT , which circulating - HB levels track .
CONCLUSIONS	Sitagliptin-induced glycaemic improvement was associated with reductions in BCAA and - HB excursions and better NEFA suppression , in parallel with improved insulin sensitivity , confirming that - HB is a readout of metabolic overload .

###24446891
BACKGROUND	Cardiac resynchronization therapy ( CRT ) improves hemodynamic function , as well as reduces hospitalizations and mortality among patients with systolic dysfunction , QRS prolongation , and heart failure .
BACKGROUND	The magnitude of the hemodynamic response is associated with improved outcomes , so optimization of this parameter is a goal of therapy .
BACKGROUND	The purpose of this study was to evaluate the effect of left ventricular ( LV ) electrical delay , as assessed by the QLV interval , on the acute hemodynamic response to CRT .
RESULTS	This study included 31 patients undergoing biventricular ICD placement .
RESULTS	At implant , invasive LV dP/dt was measured by a micromanometer catheter during biventricular ( BV ) or LV only pacing .
RESULTS	Both atrial sensing ( AS ) and atrial pacing ( AP ) modes were evaluated at 5 different AV delays , tested in randomized order .
RESULTS	The QLV interval was measured at the LV pacing site .
RESULTS	Compared with intrinsic rhythm , CRT increased LV dP/dtmax by 9.5 8.8 % with BV pacing and 10.0 9.2 % with LV pacing ( P = 0.38 ) during AS .
RESULTS	With AP , CRT increased LV dP/dtmax by 16.0 10.8 % and 15.3 11.1 % , respectively ( P = 0.47 ) .
RESULTS	QLV was strongly correlated with the hemodynamic response in all pacing configurations .
RESULTS	Multivariate analysis showed that with BV pacing QLV was an independent predictor of the hemodynamic response with a 1.7 % increase in % LV dP/dt for every 10 milliseconds prolongation of QLV .
CONCLUSIONS	LV electrical delay is a strong predictor of the acute hemodynamic response to CRT .
CONCLUSIONS	This relationship is independent of pacing mode .

###25408736
BACKGROUND	The quality of life depends on physical , psychological and social factors that are evidently influenced by the individual 's actions , prospect , attitude and behavior .
BACKGROUND	Heart disease is one of the most imperative health problems in the world .
BACKGROUND	Studies showed that exercise-based rehabilitation for patients with coronary artery disease effectively lowers the rate of cardiac death .
BACKGROUND	The intent of this study was to determine the effects of physical activity on the life quality of cardiovascular patients after coronary artery bypass graft .
METHODS	This randomized clinical trial was performed on two groups of coronary artery patients of Yazd Afshar hospital .
METHODS	All the 70 participants were post surgery coronary artery patients who were divided into two groups .
METHODS	Data was collected by two questionnaires : A personal information questionnaire and a quality of life questionnaire ( SF = 36 ) .
METHODS	Data of both groups was collected in the first and fourth month after the discharge from surgery and sessions were analyzed by SPSS 16 and by using T-test and Chi-square .
RESULTS	Results displayed that after the intervention , all the categories of the components of the quality of life were increased except for general health .
RESULTS	There was no significant differentiation between these statuses in the control group and the premier grades about the components of the social function ( 88.98 out of 100 ) .
RESULTS	The comparison of total scores of the quality of life before the intervention showed the quality of life of both groups one month after surgery was not significant ( p = 75 % ) , but in four months after surgery , the distinction between the mean grade scores of the intervention , the group was considerable ( p = 0.0001 ) .
CONCLUSIONS	The comparison of the total scores of the quality of life indicated an increase in the scores of the quality of life in the intervention group after the exercise .

###24884670
BACKGROUND	There is extensive evidence of health inequality across ethnic groups .
BACKGROUND	Inequity is a complex social phenomenon involving several underlying factors , including ethnic discrimination .
BACKGROUND	In the field of health care , it has been established that ethnic discrimination stems partially from bias or prejudice on the part of doctors .
BACKGROUND	Indeed , it has been hypothesized that patient ethnicity may affect doctors ' social cognition , thus modifying their social interactions and decision-making processes .
BACKGROUND	General practitioners ( GPs ) are the primary access point to health care for ethnic minority groups .
BACKGROUND	In this study , we examine whether patient ethnicity affects the relational and decisional features of doctoring .
METHODS	The sample was made up of 171 Belgian GPs , who were each randomly allocated to one of two experimental conditions .
METHODS	One group were given a hypertension vignette case with a Belgian patient ( non-minority patient ) , while the other group were given a hypertension vignette case with a Moroccan patient ( minority patient ) .
METHODS	We evaluated the time devoted by GPs to examining medical history ; time devoted by GPs to examining socio-relational history ; cardiovascular risk assessments by GPs ; electrocardiogram ( ECG ) recommendations by GPs , and drug prescriptions by GPs .
RESULTS	We observed that for ethnic minority patients , GPs prescribed more drugs and devoted less time to examining socio-relational history .
RESULTS	Neither cardiovascular risk assessments nor ECG recommendations were affected by patient ethnicity .
RESULTS	GPs who were very busy devoted less time to examining medical history when dealing with minority patients .
CONCLUSIONS	We found no evidence that GPs discriminated against ethnic minority patients when it came to medical decisions .
CONCLUSIONS	However , our study did identify a risk of drugs being used inappropriately in some ethnic-specific encounters .
CONCLUSIONS	We also observed that , with ethnic minority patients , GPs engage less in the relational dimension of doctoring , particularly when working within a demanding environment .
CONCLUSIONS	In general practice , the quality of the relationship between doctor and patient is an essential component of the effective management of chronic illness .
CONCLUSIONS	Our research highlights the complexity of ethnic discrimination in general practice , and the need for further studies .

###24672936
OBJECTIVE	To observe the clinical effect of acupuncture on acute heart failure ( AHF ) patients .
METHODS	Totally 60 patients who were diagnosed as AHF were assigned to the acupuncture group and the control group , 30 in each group .
METHODS	Those in the control group received inotropic agents , preload and afterload reducing therapy , anti-infection and so on .
METHODS	Besides , those in the acupuncture group received needling at relative points , once daily for 5 consecutive days .
METHODS	The mean arterial pressure ( MAP ) , heart rate ( HR ) , cardiac index ( CI ) , stroke volume index ( SI ) , left ventricle working index ( LCWI ) were monitored by thermodilution pulse-indicated continuous cardiac output ( PiCCO ) technique .
METHODS	Changes of the aforesaid data were compared between before and after treatment .
METHODS	The ICU length of stay , readmission rate , and the 28-day mortality were also compared between the two groups .
RESULTS	After 5 days of the treatment , CI , SI , and LCWI increased more obviously ( P < 0.01 ) , HR and MAP decreased significantly ( P < 0.05 ) .
RESULTS	Of them , CI , SI , and LCWI increased more obviously in the acupuncture group ( P < 0.05 ) .
RESULTS	There was no obvious difference in HR or MAP between the two groups ( P > 0.05 ) .
RESULTS	Compared with the first day of admission in the same group , CI , SI , and LCWI obviously increased in the acupuncture group from the second day ( P < 0.05 ) .
RESULTS	HR started to decrease since the fourth day ( P < 0.05 ) , and MAP began to decrease until the fifth day ( P < 0.05 ) .
RESULTS	CI , SI , and LCWI started to increase in the control group from the third day ( P < 0.05 ) ; HR and MAP both began to decrease since the fifth day ( P < 0.05 ) .
RESULTS	Compared with the control group , the ICU length of stay was obviously shortened in the acupuncture group ( P < 0.05 ) .
RESULTS	The readmission rate and the 28-day mortality rate were lower than those of the control group ( P < 0.05 ) .
CONCLUSIONS	The combination of acupuncture and Western medical therapy might strengthen acute heart failure patients ' heart functions , elevate the therapeutic effect , and improve the prognosis .

###25476448
OBJECTIVE	To explore the effect of acupuncture at HT7 on heart rate variability ( HRV ) in healthy volunteers .
METHODS	120 subjects were divided into four groups using a random number table .
METHODS	The following groups of acupuncture interventions were used : HT7 verum acupuncture ; HT7 non-penetrating sham acupuncture ; acupuncture at a sham point ; and no acupuncture .
METHODS	HRV was recorded 10min before , during and after each stimulation using an Actiheart ECG recorder .
RESULTS	The HT7 verum acupuncture group had higher very-low frequency , low frequency and high frequency components of HRV compared with the control groups during but not after acupuncture .
RESULTS	The HT7 verum acupuncture group also had higher SD of normal intervals compared with the sham needling and no acupuncture control groups .
CONCLUSIONS	Our preliminary study suggests , subject to limitations , that acupuncture at HT7 could affect cardiac autonomic neural regulation in healthy subjects , manifest as increased HRV , most likely via the parasympathetic system .
BACKGROUND	ChiCTR-TRC-08000302 .

###24862923
BACKGROUND	Intraoperative radiation therapy ( IORT ) is an emerging option for partial breast radiotherapy in select women with early stage breast cancer .
BACKGROUND	We assessed short-term clinical and sonographic findings after breast conservation ( BCT ) and IORT .
METHODS	An IRB-approved , single institution retrospective chart review was conducted of patients ( pts ) treated with BCT/IORT from 1/2011 to 6/2012 .
METHODS	Follow-up clinical breast exams and ultrasounds ( US ) obtained 6 and 12 months after BCT/IORT were retrospectively reviewed by a single breast radiologist ( JD ) for sonographic findings .
METHODS	P values were calculated using McNemar 's test , Wilcoxon Rank Sum Test , and Chi-square .
RESULTS	Seventy-one pts underwent BCT/IORT and 38 pts had an US .
RESULTS	All 38 pts had a seroma , 10/38 ( 26 % ) pts were symptomatic .
RESULTS	Eighteen pts had deep tissue closure ( DTC ) of the lumpectomy cavity with 5/18 ( 28 % ) DTC pts being symptomatic at follow-up versus 5/33 ( 15 % ) without DTC ( P = 0.296 ) .
RESULTS	At 6 months , DTC resulted in smaller seroma cavity volumes compared to those without DTC ( P = 0.03 ) .
CONCLUSIONS	Presence of a seroma is commonplace post BCT/IORT ; symptomatic seromas are uncommon .
CONCLUSIONS	DTC generated smaller seromas .
CONCLUSIONS	Longer follow-up with serial US performed in all BCT/IORT pts could be considered to document natural progression/regression of symptoms and seromas .

###25330631
OBJECTIVE	To evaluate the sustained efficacy of 2-year sublingual immunotherapy ( SLIT ) and 1 year after 2-year SLIT in children with allergic rhinitis ( AR ) .
METHODS	This study is a randomized , open and prospective trial .
METHODS	One hundred twenty children ( between 4 and 11 years old ) suffering from AR duo to mite were chosen from November , 2008 to June , 2009 in department of otolaryngology in our hospital divided into two groups : 60 underwent 2-year course of SLIT and one year follow-up combined with 3-year drug therapy as SLIT group ; 60 received only drug therapy as control group .
METHODS	The patients were evaluated at three time points ( baseline , end of SLIT and 1 year after SLIT discontinuation ) regarding symptom scores including total nasal symptom score ( TNSS ) , sneezing , rhinorrhoea , nasal obstruction , nasal itching and total medication scores ( TMS ) and adverse reaction .
RESULTS	( 1 ) At the end of SLIT , the symptom scores excepting sneezing and total medication scores in SLIT group are obviously lower than those in control group ( P < 0.01 ) .
RESULTS	At 1 year after SLIT discontinuation , all of the score including sneezing ( P < 0.05 ) in SLIT group are lower than those of control group .
RESULTS	( 2 ) At the end of SLIT and 1 year after SLIT discontinuation , all of the scores are lower than those at baseline in SLIT group ( P < 0.01 ) ; the scores were no different in SLIT group between the end of SLIT and 1 year after SLIT discontinuation ( P > 0.05 ) .
RESULTS	But at the end of SLIT and 1 year after SLIT discontinuation , TMS was higher than it at baseline in control group ( P < 0.01 ) .
RESULTS	At 1 year after SLIT discontinuation , nasal obstruction score was higher than it at baseline ( P < 0.05 ) .
CONCLUSIONS	SLIT can obviously improve the AR and the efficacy can sustain after 1-year SLIT discontinua tion .
CONCLUSIONS	Drug increased in 3 years without SLIT .

###24912059
OBJECTIVE	This report summarizes the first studies on individual placement and support ( IPS ) in the field of physical medicine and rehabilitation ( PM&R ) and discusses adaptation of the model .
OBJECTIVE	Research related to the implementation and evaluation of the use of IPS in the VA System of Spinal Cord Injury Care is reviewed .
OBJECTIVE	Results suggest that IPS was more effective than traditional vocational rehabilitation .
OBJECTIVE	With physical disabilities , the model needs adaptation with respect to integration , disclosure , and job development while following the core principles .
OBJECTIVE	Special consideration is needed with respect to caseload size and transportation issues .
METHODS	Published results from the Spinal Cord Injury Vocational Integration Program ( SCI-VIP ) study and clinical field observations .
CONCLUSIONS	IPS can be successfully adapted to physical medicine and rehabilitation .

###25575420
OBJECTIVE	To compare functional outcomes of 7-year-old ( school-age ) children born small for gestational age ( SGA ; ie , a birth weight z score -1 SD ) , with appropriate for gestational age ( AGA ) peers , born moderately preterm or full term .
METHODS	Data were collected as part of the Longitudinal Preterm Outcome Project study , a community-based , prospective cohort study of 336 AGA and 42 SGA born children ( median gestational age 35 weeks , range 31-41 ) .
METHODS	Of the SGA children , 32 were moderately preterm , 10 were full term ; of the AGA , these numbers were 216 and 120 , respectively .
METHODS	At 6.9 years , we assessed intelligence , verbal memory , attention , visuomotor integration , and motor skills and we collected the parent-reported executive functioning .
METHODS	We compared the outcomes of the SGA children with those of their AGA peers .
RESULTS	The performance of SGA children was similar to that of their AGA peers , except for attention control which was abnormal more often in SGA children ( OR 3.99 , 95 % CI 1.32-12 .12 ) .
RESULTS	The IQ of SGA children was 3 points lower , but this difference failed to reach significance .
CONCLUSIONS	At school age , children born SGA have a greater risk of abnormal test scores on attention control than children born AGA , independent of gestational age .
CONCLUSIONS	Their motor and many other cognitive functions are similar .
CONCLUSIONS	The impact of these outcomes seems limited .
CONCLUSIONS	Nevertheless , the consequences for school performance deserve attention .

###24912486
OBJECTIVE	The aim of this study was to compare high-flow nasal cannula ( HFNC ) and conventional O2 therapy ( OT ) in paediatric cardiac surgical patients ; the primary objective of the study was to evaluate whether HFNC was able to improve PaCO2 elimination in the first 48 h after extubation postoperatively .
METHODS	We conducted a randomized , controlled trial in pediatric cardiac surgical patients under 18 months of age .
METHODS	At the beginning of the weaning of ventilation , patients were randomly assigned to either of the following groups : OT or HFNC .
METHODS	Arterial blood samples were collected before and after extubation at the following time points : 1 , 6 , 12 , 24 and 48 h.
METHODS	The primary outcome was comparison of arterial PaCO2 postextubation ; secondary outcomes were PaO2 and PaO2/fractional inspired oxygen ( FiO2 ) ratio , rate of treatment failure and need of respiratory support , rate of extubation failure , rate of atelectasis , simply to complications and the length of paediatric cardiac intensive care unit stay .
RESULTS	Demographic and clinical variables were comparable in the two groups .
RESULTS	Analysis of variance for repeated measures showed that PaCO2 was not significantly different between the HFNC and OT groups ( P = 0.5 ) , whereas PaO2 and PaO2/FiO2 were significantly improved in the HFNC group ( P = 0.01 and P = 0.001 ) .
RESULTS	The rate of reintubation was not different in the two groups ( P = 1.0 ) , whereas the need for noninvasive respiratory support was 15 % in the OT group and none in the HFNC group ( P = 0.008 ) .
CONCLUSIONS	HFNC had no impact on PaCO2 values .
CONCLUSIONS	The use of HFNC appeared to be safe and improved PaO2 in paediatric cardiac surgical patients .

###25454283
OBJECTIVE	In contrast to conventional ( CONV ) neuromuscular electrical stimulation ( NMES ) , the use of `` wide-pulse , high-frequencies '' ( WPHF ) can generate higher forces than expected by the direct activation of motor axons alone .
OBJECTIVE	We aimed at investigating the occurrence , magnitude , variability and underlying neuromuscular mechanisms of these `` Extra Forces '' ( EF ) .
METHODS	Electrically-evoked isometric plantar flexion force was recorded in 42 healthy subjects .
METHODS	Additionally , twitch potentiation , H-reflex and M-wave responses were assessed in 13 participants .
METHODS	CONV ( 25Hz , 0.05 ms ) and WPHF ( 100Hz , 1ms ) NMES consisted of five stimulation trains ( 20s on-90s off ) .
RESULTS	K-means clustering analysis disclosed a responder rate of almost 60 % .
RESULTS	Within this group of responders , force significantly increased from 4 % to 16 % of the maximal voluntary contraction force and H-reflexes were depressed after WPHF NMES .
RESULTS	In contrast , non-responders showed neither EF nor H-reflex depression .
RESULTS	Twitch potentiation and resting EMG data were similar between groups .
RESULTS	Interestingly , a large inter - and intrasubject variability of EF was observed .
CONCLUSIONS	The responder percentage was overestimated in previous studies .
CONCLUSIONS	This study proposes a novel methodological framework for unraveling the neurophysiological mechanisms involved in EF and provides further evidence for a central contribution to EF in responders .

###25229916
BACKGROUND	There is a lack of consensus about whether the initial imaging method for patients with suspected nephrolithiasis should be computed tomography ( CT ) or ultrasonography .
METHODS	In this multicenter , pragmatic , comparative effectiveness trial , we randomly assigned patients 18 to 76 years of age who presented to the emergency department with suspected nephrolithiasis to undergo initial diagnostic ultrasonography performed by an emergency physician ( point-of-care ultrasonography ) , ultrasonography performed by a radiologist ( radiology ultrasonography ) , or abdominal CT. .
METHODS	Subsequent management , including additional imaging , was at the discretion of the physician .
METHODS	We compared the three groups with respect to the 30-day incidence of high-risk diagnoses with complications that could be related to missed or delayed diagnosis and the 6-month cumulative radiation exposure .
METHODS	Secondary outcomes were serious adverse events , related serious adverse events ( deemed attributable to study participation ) , pain ( assessed on an 11-point visual-analogue scale , with higher scores indicating more severe pain ) , return emergency department visits , hospitalizations , and diagnostic accuracy .
RESULTS	A total of 2759 patients underwent randomization : 908 to point-of-care ultrasonography , 893 to radiology ultrasonography , and 958 to CT. .
RESULTS	The incidence of high-risk diagnoses with complications in the first 30 days was low ( 0.4 % ) and did not vary according to imaging method .
RESULTS	The mean 6-month cumulative radiation exposure was significantly lower in the ultrasonography groups than in the CT group ( P < 0.001 ) .
RESULTS	Serious adverse events occurred in 12.4 % of the patients assigned to point-of-care ultrasonography , 10.8 % of those assigned to radiology ultrasonography , and 11.2 % of those assigned to CT ( P = 0.50 ) .
RESULTS	Related adverse events were infrequent ( incidence , 0.4 % ) and similar across groups .
RESULTS	By 7 days , the average pain score was 2.0 in each group ( P = 0.84 ) .
RESULTS	Return emergency department visits , hospitalizations , and diagnostic accuracy did not differ significantly among the groups .
CONCLUSIONS	Initial ultrasonography was associated with lower cumulative radiation exposure than initial CT , without significant differences in high-risk diagnoses with complications , serious adverse events , pain scores , return emergency department visits , or hospitalizations .
CONCLUSIONS	( Funded by the Agency for Healthcare Research and Quality . )

###24996842
BACKGROUND	Emerging evidence suggests modulating the microbiota in the large bowel of patients with chronic kidney disease ( CKD ) through pre - and/probiotic supplementation may inhibit the development of key nephrovascular toxins .
BACKGROUND	To date , quality intervention trials investigating this novel treatment in CKD are lacking .
BACKGROUND	The aim of SYNERGY is to assess the effectiveness of synbiotics ( co-administration of pre - and probiotics ) as a potential treatment targeting the synthesis of uremic toxins , specifically , indoxyl sulphate ( IS ) and p-cresyl sulphate ( PCS ) .
METHODS	Thirty-seven patients with moderate to severe CKD ( Stage IV and V , pre-dialysis ) will be recruited to a double-blind , placebo-controlled , randomised cross-over trial .
METHODS	Patients will be provided with synbiotic therapy or placebo for 6 weeks , with a 4week washout before cross-over .
METHODS	The primary outcome is serum IS , total and free ( unbound ) concentrations , measured using ultra-performance liquid chromatography .
METHODS	Secondary outcomes include serum PCS , total and free ( unbound ) concentrations ; cardiovascular risk , measured by serum lipopolysaccharides , serum trimethylamine-N-oxide ( TMAO ) and inflammation and oxidative stress markers ; kidney damage , measured by 24hour proteinuria and albuminuria , estimated glomerular filtration rate and renal tubule damage ( urinary kidney injury molecule-1 ) ; patients ' self assessed quality of life ; and gastrointestinal symptoms .
METHODS	In addition , the effects on the community structure of the stool microbiota will be explored in a subset of patients to validate the mechanistic rationale underpinning the synbiotic therapy .
CONCLUSIONS	IS and PCS are two novel uremic toxins implicated in both cardiovascular disease ( CVD ) and progression of CKD .
CONCLUSIONS	Preliminary studies indicate that synbiotic therapy maybe a promising strategy when considering a targeted , tolerable and cost-efficient therapy for lowering serum IS and PCS concentrations .
CONCLUSIONS	This trial will provide high quality ` proof-of-concept ' data to elucidate both the efficacy of synbiotic therapy for lowering the toxins and whether reductions in serum IS and PCS translate into clinical benefits .
CONCLUSIONS	Considering the potential of pre - and probiotics to not only shift toxin levels , but to also impede CVD and CKD progression , SYNERGY will provide vital insight into the effectiveness of this innocuous nutritional therapy .
BACKGROUND	Universal Trial Number : U1111-1142-4363 .
BACKGROUND	Australian New Zealand Clinical Trials Registry Number : ACTRN12613000493741 , date registered : 2nd May 2013 .

###24714011
BACKGROUND	Profound side-effects following intrathecal use of local anesthetics as the sole drugs of choice make spinal anesthesia for open appendicectomy uncommon .
OBJECTIVE	The aim of this study was to evaluate the effectiveness of intra-operative analgesia produced by intrathecal tramadol and fentanyl during bupivacaine spinal anesthesia for open appendicectomy .
METHODS	A prospective randomized study was performed .
METHODS	A total of 186 American Society of Anesthesiologists 1 or 11 patients scheduled for emergency open appendicectomy were analyzed .
METHODS	Group FB ( n = 62 ) received intrathecal fentanyl 25 g plus 3 ml of 0.5 % hyperbaric bupivacaine , Group SB ( n = 62 ) received 0.5 ml normal saline plus 3 ml of 0.5 % hyperbaric bupivacaine and Group TB ( n = 62 ) received intrathecal tramadol 25 mg plus 3 ml of 0.5 % hyperbaric bupivacaine .
METHODS	Visual analog scale scores and frequency of subjective symptoms among patients in the three groups formed the primary outcome measure of this study .
RESULTS	Effective intraoperative sensory block was achieved in 100 % of patients in group FB and TB while 29 ( 46.8 % ) patients in group SB had ineffective sensory block ( P = 0.0001 ) .
RESULTS	The pain free period was significantly longer in patients in Group FB than Group SB and TB .
RESULTS	Mean time for Group FB with regard to first analgesic request was 304.73 67.91 min , Group SB was 146.59 36.62 and Group TB was 238.39 61.28 min .
RESULTS	Incidence of complications were comparable among the three groups .
CONCLUSIONS	This study showed that intrathecal tramadol ( 25 mg ) can safely replace intrathecal fentanyl ( 25 g ) in the management of visceral pain and discomfort during subarachnoid block for appendicectomy .

###24485000
OBJECTIVE	Accumulation of visceral adipose tissue is associated with insulin resistance and cardio-vascular disease .
OBJECTIVE	The aim of this study was to elucidate whether removal of a large amount of visceral fat by omentectomy in conjunction with Roux en-Y gastric bypass operation ( RYGB ) results in enhanced improvement of insulin sensitivity compared to gastric bypass surgery alone .
METHODS	Eighty-one obese women scheduled for RYGB were included in the study .
METHODS	They were randomized to RYGB or RYGB in conjunction with omentectomy .
METHODS	Insulin sensitivity was measured by hyperinsulinemic euglycemic clamp before operation and sixty-two women were also reexamined 2 years post-operatively .
METHODS	The primary outcome measure was insulin sensitivity and secondary outcome measures included cardio-metabolic risk factors .
RESULTS	Two-year weight loss was profound but unaffected by omentectomy .
RESULTS	Before intervention , there were no clinical or metabolic differences between the two groups .
RESULTS	The difference in primary outcome measure , insulin sensitivity , was not significant between the non-omentectomy ( 6.71.6 mg/kg body weight/minute ) and omentectomy groups ( 6.61.5 mg/kg body weight/minute ) after 2 years .
RESULTS	Nor did any of the cardio-metabolic risk factors that were secondary outcome measures differ significantly .
CONCLUSIONS	Addition of omentectomy to gastric bypass operation does not give an incremental effect on long term insulin sensitivity or cardio-metabolic risk factors .
CONCLUSIONS	The clinical usefulness of omentectomy in addition to gastric bypass operation is highly questionable .
BACKGROUND	NCT01785134 .

###25564317
OBJECTIVE	Convulsive Status Epilepticus ( CSE ) is a common neurological emergency with patients presenting with prolonged epileptic activity .
OBJECTIVE	Sub-optimal management is coupled with high morbidity and mortality .
OBJECTIVE	Continuous electroencephalogram ( EEG ) monitoring is considered essential by the National Institute for Health and Care Excellence ( NICE ) in the management of Convulsive Refractory Status Epilepticus ( CRSE ) .
OBJECTIVE	The aim of this research was to determine current clinical practice in the management of CRSE amongst adults in intensive care units ( ICU ) in the UK and establish if the use of a standardised protocol requires re-enforcement within trusts .
METHODS	75 randomly selected UK NHS Trusts were contacted and asked to complete a questionnaire in addition to providing their protocol for CRSE management in ICU .
RESULTS	55 ( 73 % ) trusts responded .
RESULTS	While 31 ( 56 % of responders ) had a protocol available in ICU for early stages of CSE , just 21 ( 38 % ) trusts had specific guidelines if CRSE occurred .
RESULTS	Only 23 ( 42 % ) trusts involved neurologists at any stage of management and just 18 ( 33 % ) have access to continuous EEG monitoring .
CONCLUSIONS	This study identifies significant inconsistency in the management of CSE in ICU 's across the UK .
CONCLUSIONS	A minority of ICU units have a protocol for CRSE or access to continuous EEG monitoring despite it being considered fundamental for management and supported by NICE guidance .

###24667035
BACKGROUND	Controlling hypertension rates and maintaining normal blood pressure , particularly in resource-constrained settings , represent ongoing challenges of effective and affordable implementation in health care .
BACKGROUND	One of the strategies being largely advocated to improve high blood pressure calls for salt reduction strategies .
BACKGROUND	This study aims to estimate the impact of a population-level intervention based on sodium reduction and potassium increase - in practice , introducing a low-sodium , high-potassium salt substitute - on adult blood pressure levels .
METHODS	The proposed implementation research study includes two components : Phase 1 , an exploratory component , and Phase 2 , an intervention component .
METHODS	The exploratory component involves a triangle taste test and a formative research study designed to gain an understanding of the best implementation methods .
METHODS	Phase 2 involves a pragmatic stepped wedge trial design where the intervention will be progressively implemented in several clusters starting the intervention randomly at different times .
METHODS	In addition , we will evaluate the implementation strategy using a cost-effectiveness analysis .
CONCLUSIONS	This is the first project in a Latin-American setting to implement a salt substitution intervention at the population level to tackle high blood pressure .
CONCLUSIONS	Data generated and lessons learnt from this study will provide a strong platform to address potential interventions applicable to other similar low - and middle-income settings .
BACKGROUND	This study is registered in ClinicalTrials.gov NCT01960972 .

###25605211
OBJECTIVE	To investigate bladder and intestinal function recovery and quality of sexual life after laparoscopic nerve-sparing radical hysterectomy ( LNRH ) for treatment of early invasive cervical carcinoma .
METHODS	Subjects included patients who underwent radical hysterectomy by laparotomy who were randomly assigned to 2 groups : 30 patients who underwent LNRH and 35 classical laparoscopic radical hysterectomy ( LRH ) .
METHODS	We assessed the patients general clinical information , surgical characteristics , pathological findings , and adjuvant therapies .
METHODS	A urodynamic study was used to assess bladder function .
METHODS	Intestinal function recovery and quality of sexual life were evaluated by questionnaire .
RESULTS	No significant differences were found in age , surgery characteristics , pathological findings , adjuvant therapies , and main adverse effects between the 2 groups .
RESULTS	The mean duration of the postoperative catheterization ( DPC ) in group LNRH was shorter than that in group LRH ( P < 0.001 ) .
RESULTS	The maximum flow rate , maximum cystometric capacity , maximum detrusor pressure and urinary complications in group LNRH were better than those in group LRH .
RESULTS	The quality of sexual life evaluated according to the female sexual function index ( FSFI ) was better in group LNRH than in those who underwent LRH .
RESULTS	The intestinal function of patients in group LNRH also recovered better compared with patients in group LRH .

###24528690
BACKGROUND	Omega-3 fatty acids in free fatty acid form have enhanced bioavailability , and plasma levels are less influenced by food than for ethyl ester forms .
OBJECTIVE	The aim was to evaluate the safety and lipid-altering efficacy in subjects with severe hypertriglyceridemia of an investigational pharmaceutical omega-3 free fatty acid ( OM3-FFA ) containing eicosapentaenoic acid and docosahexaenoic acid .
METHODS	This was a multinational , double-blind , randomized , out-patient study .
METHODS	Men and women with triglycerides ( TGs ) 500 mg/dL , but < 2000 mg/dL , took control ( olive oil [ OO ] 4 g/d ; n = 99 ) , OM3-FFA 2 g/d ( plus OO 2 g/d ; n = 100 ) , OM3-FFA 3 g/d ( plus OO 1 g/d ; n = 101 ) , or OM3-FFA 4 g/d ( n = 99 ) capsules for 12 weeks in combination with the National Cholesterol Education Program Therapeutic Lifestyle Changes diet .
RESULTS	Fasting serum TGs changed from baseline by -25.9 % ( P < .01 vs OO ) , -25.5 % ( P < .01 vs OO ) , and -30.9 % ( P < .001 vs OO ) with 2 , 3 , and 4 g/d OM3-FFA , respectively , compared with -4.3 % with OO .
RESULTS	Non-high-density lipoprotein cholesterol ( non-HDL-C ) , total cholesterol-to-HDL-C ratio , very low-density lipoprotein cholesterol , remnant-like particle cholesterol , apolipoprotein CIII , lipoprotein-associated phospholipase A2 , and arachidonic acid were significantly lowered ( P < .05 at each OM3-FFA dosage vs OO ) ; and plasma eicosapentaenoic acid and docosahexaenoic acid were significantly elevated ( P < .001 at each OM3-FFA dosage vs OO ) .
RESULTS	With OM3-FFA 2 and 4 g/d ( but not 3 g/d ) , low-density lipoprotein cholesterol was significantly increased compared with OO ( P < .05 vs OO ) .
RESULTS	High-sensitivity C-reactive protein responses with OM3-FFA did not differ significantly from the OO response at any dosage .
RESULTS	Fewer subjects reported any adverse event with OO vs OM3-FFA , but frequencies across dosage groups were similar .
RESULTS	Discontinuation due to adverse event , primarily gastrointestinal , ranged from 5 % to 7 % across OM3-FFA dosage groups vs 0 % for OO .
CONCLUSIONS	OM3-FFA achieved the primary end point for TG lowering and secondary end point of non-HDL-C lowering at 2 , 3 , and 4 g/d in persons with severe hypertriglyceridemia .
CONCLUSIONS	This trial was registered at www.clinicaltrials.gov as NCT01242527 .

###25491069
BACKGROUND	High levels of emotional distress in cancer patients often goes unnoticed in daily clinical routine , resulting in severe undertreatment of mental health problems in this patient group .
BACKGROUND	Screening tools can be used to increase case identification , however , screening alone does not necessarily translate into better mental health for the patient .
BACKGROUND	Doctors play a key role in providing basic emotional support and transferring the patients in need of such specific support to mental health professionals .
BACKGROUND	This study investigates whether a stepped care model , combining screening , doctor consultation and professional psycho-oncological service in a structured way , improves the emotional wellbeing of cancer patients .
METHODS	This study is a cluster randomized trial with two parallel groups ( intervention vs. care as usual ) , set in an academic hospital .
METHODS	Participants are cancer patients , a total of 1,000 at baseline .
METHODS	The intervention consists of stepped psychosocial care .
METHODS	Step one : screening for distress , step two : feedback of screening results to the doctor in charge of the patient and consultation with the patient , and step three : based on a shared patient-doctor decision , either transferal to the consultation liaison ( CL ) service or not .
METHODS	The outcome will be emotional well-being half a year after baseline , ascertained with the Hospital Anxiety and Depression Scale .
METHODS	Randomization will be done by the cluster randomization of wards .
CONCLUSIONS	Mental health problems not only cause emotional suffering but also direct and indirect costs .
CONCLUSIONS	This calls for timely and adequate psychosocial support , especially as we know that such support is effective .
CONCLUSIONS	However , not every cancer patient can and must be treated by a mental health professional .
CONCLUSIONS	Allocating limited resources most sensibly and economically is of crucial importance for our healthcare system to ensure the best quality of care to as many patients as possible .
CONCLUSIONS	It is the hope of the STEPPED CARE trial that this model is both effective and efficient , and that it can be implemented in other hospitals as well , if proven to be effective .
BACKGROUND	Clinical Trials Register ( Clinicaltrials.gov ) identifier : NCT01859429 registration date 17 May 2013 .

###24555753
BACKGROUND	Low-dose clarithromycin has been recommended for the treatment of chronic rhinosinusitis without nasal polyps .
BACKGROUND	However , it is uncertain whether a high dose of clarithromycin is more effective than a low dose .
METHODS	Forty-three chronic rhinosinusitis patients were randomised to low-dose or high-dose clarithromycin groups , and clinical efficacy was evaluated .
METHODS	Pre - and post-treatment measures included : nasal symptom assessment , endoscopic inspection ( Lund-Kennedy system ) , a quality of life questionnaire ( the Sino-Nasal Outcome Test 20 ) and examination of cytokine levels ( interleukin-5 and -8 ) in nasal secretions .
RESULTS	The high dose of clarithromycin was significantly better in terms of clinical efficacy than the low dose for the treatment of chronic rhinosinusitis ( p < 0.025 ) .
RESULTS	Significant differences in nasal cytokine levels ( interleukin-5 and -8 ) were also observed between the low-dose and high-dose groups after short-term clarithromycin treatment ( p < 0.025 ) .
CONCLUSIONS	Short-term , high-dose clarithromycin appears to be more effective for the treatment of chronic rhinosinusitis than low-dose clarithromycin .

###25631970
BACKGROUND	Iron deficiency , associated with a decline in cognitive function , is the most common nutritional deficiency globally .
BACKGROUND	The present study aimed to identify the impact of weekly iron supplements on the attention function of female students from a high school in North Khorasan Province , Iran .
METHODS	This was a blind , controlled , clinical trial study , involving 200 female students who were chosen using the stratified randomised sampling method .
METHODS	First , laboratory studies were performed to detect iron consumption limitations .
METHODS	Next , the 200 students were divided randomly and equally into case and control groups .
METHODS	The case group was treated with 50 mg of ferrous sulfate twice a week for 16 weeks .
METHODS	We compared both groups ' data on attention , iron status and erythrocyte indices .
METHODS	Questionnaires were used to collect demographic data , while clinical data was collected using complete blood count and Toulouse-Piron tests .
METHODS	Data was analysed using descriptive statistics , as well as paired and independent t-tests .
RESULTS	The mean attention scores of the case and control groups were 104.8 7.0 and 52.7 9.6 , respectively ( p < 0.001 ) .
RESULTS	The mean haemoglobin levels of the two groups were 12.5 0.9 and 11.2 1.0 , respectively ( p < 0.001 ) .
RESULTS	Compared to the control group , the attention scores and haemoglobin concentrations of the case group were found to be improved by approximately 90 % and 10 % , respectively .
CONCLUSIONS	Oral iron supplements ( 50 mg twice a week for 16 weeks ) were able to improve the attention span and haematologic indices of female high school students .

###24710974
OBJECTIVE	The aim of the present study was to evaluate the effect of applying electroencephalogram ( EEG ) biofeedback ( neurobiofeedback ) or electromyographic ( EMG ) biofeedback to conventional occupational therapy ( OT ) on improving hand function in stroke patients .
METHODS	This study was designed as a preliminary clinical trial .
METHODS	Thirty patients with stroke were entered the study .
METHODS	Hand function was evaluated by Jebsen Hand Function Test pre and post intervention .
METHODS	Patients were allocated to 3 intervention cohorts : ( 1 ) OT , ( 2 ) OT plus EMG-biofeedback therapy , and ( 3 ) OT plus neurofeedback therapy .
METHODS	All patients received 10 sessions of conventional OT .
METHODS	Patients in cohorts 2 and 3 also received EMG-biofeedback and neurofeedback therapy , respectively .
METHODS	EMG-biofeedback therapy was performed to strengthen the abductor pollicis brevis ( APB ) muscle .
METHODS	Neurofeedback training was aimed at enhancing sensorimotor rhythm after mental motor imagery .
RESULTS	Hand function was improved significantly in the 3 groups .
RESULTS	The spectral power density of the sensorimotor rhythm band in the neurofeedback group increased after mental motor imagery .
RESULTS	Maximum and mean contraction values of electrical activities of the APB muscle during voluntary contraction increased significantly after EMG-biofeedback training .
CONCLUSIONS	Patients in the neurofeedback and EMG-biofeedback groups showed hand improvement similar to conventional OT .
CONCLUSIONS	Further studies are suggested to assign the best protocol for neurofeedback and EMG-biofeedback therapy .

###24256171
METHODS	Prospective longitudinal study .
OBJECTIVE	To explore the working mechanism of manual therapy , we investigated whether 3 cervical spine variables were mediators of the effect of manual therapy on headache frequency .
OBJECTIVE	Background Manual therapy has been shown to reduce headache frequency in participants with chronic tension-type headache ( CTTH ) .
OBJECTIVE	To what extent specific elements of treatment contribute to the effectiveness of manual therapy in CTTH is unknown .
METHODS	One hundred eighty-two participants with CTTH participated in a prospective longitudinal study : 142 underwent manual therapy and 40 participants received usual care by their general practitioner .
METHODS	Regression analysis was performed according to the steps described by Baron and Kenny , and the proportion of mediated effect was estimated for 3 potential mediators : ( 1 ) cervical range of motion , ( 2 ) neck flexor endurance , and ( 3 ) forward head posture .
METHODS	Outcome was defined as a 50 % or greater reduction in headache days .
RESULTS	Neck flexor endurance mediated 24.5 % of the effect of manual therapy .
RESULTS	Cervical range of motion and forward head posture showed no mediated effect .
CONCLUSIONS	Increased neck flexor endurance appears to be a working mechanism of manual therapy .
CONCLUSIONS	This finding supports isometric training of neck flexors in participants with CTTH .
CONCLUSIONS	Trial registered with Netherlands Trial Register ( TR 1074 ) .

###25207986
BACKGROUND	ADHD is prevalent in adults and frequently associated with impairment and distress .
BACKGROUND	While medication is often the first line of treatment a high proportion of people with the condition are not fully treated by medication alone , can not tolerate medication or do not wish to take it .
BACKGROUND	Preliminary studies suggest that psychosocial approaches are a promising adjunctive or alternative treatment option .
BACKGROUND	To date , individual cognitive-behaviour therapy ( CBT ) has been found to be efficacious in three randomized controlled trials ( RCTs ) .
BACKGROUND	There is a need for more RCTs to be carried out in order to replicate these results in different sites , to further investigate the acceptability and feasibility of CBT in this population and to further develop CBT approaches based on a psychological model .
BACKGROUND	This randomized controlled trial investigates the efficacy of individual , formulation-based CBT when added to treatment-as-usual as compared with treatment as usual alone .
METHODS	Sixty patients with a diagnosis of adult ADHD attending a specialist clinic are randomly allocated to 1 of 2 treatments , ` Treatment as Usual ' ( TAU ) or TAU plus 16 sessions individual CBT ( TAU + CBT ) .
METHODS	In the TAU + CBT , the first 15 sessions take place over 30 weeks with a 16th ` follow-up ' session at 42 weeks .
METHODS	Outcomes are assessed at 30 weeks and 42 weeks following randomization .
METHODS	The two primary outcomes are self-rated ADHD symptoms and functioning ( occupational and social ) .
METHODS	Secondary outcomes include distress , mood , ADHD-related cognitions , ADHD-related behaviours and informant-rated ADHD symptoms .
METHODS	The primary analysis will include all participants for whom data is available and will use longitudinal regression models to compare treatments .
METHODS	Secondary outcomes will be analysed similarly .
CONCLUSIONS	The results of the study will provide information about a ) whether CBT adds benefit over and above TAU for ADHD and , b ) if CBT is found to be efficacious , potential mechanisms of change and predictors of efficacy .
BACKGROUND	Current Controlled Trials ISRCTN03732556 , assigned 04/11/2010 .

###24965834
BACKGROUND	Nebulisers aid the treatment of respiratory diseases , including asthma , but they require electricity and are often cost-prohibitive for low - and middle-income countries .
OBJECTIVE	The aim of this study was to compare a low-cost , human-powered nebuliser compressor with an electric nebuliser compressor for the treatment of mild to moderate asthma exacerbations in adults and children .
METHODS	This was a non-blinded , parallel-group , equivalence study , with 110 subjects between 6 and 65 years of age , conducted in the emergency department of a district hospital in Ilopango , El Salvador .
METHODS	Participants were assigned by random allocation to receive a 2.5-mg dose of salbutamol from the experimental human-powered nebuliser or the electric nebuliser control .
METHODS	All assigned participants completed treatment and were included in analysis .
METHODS	The study was not blinded as this was clinically unfeasible ; however , data analysis was blinded .
RESULTS	The mean improvement in peak flow of the experimental and control groups was 37.5 ( 95 % confidence interval ( CI ) 26.7-48 .2 ) l/min and 38.7 ( 95 % CI , 26.1-51 .3 ) l/min , respectively , with a mean difference of 1.3 ( 95 % CI , -15.1 to 17.7 ) l/min .
RESULTS	The mean improvement in percent-expected peak flow for the experimental and control groups was 12.3 % ( 95 % CI , 9.1-15 .5 % ) and 13.8 % ( 95 % CI , 9.8-17 .9 % ) , respectively , with a mean difference of 1.5 % ( 95 % CI , -3.6 to 6.6 % ) .
CONCLUSIONS	The human-powered nebuliser compressor is equivalent to a standard nebuliser compressor for the treatment of mild-to-moderate asthma .
CONCLUSIONS	( Funded by the Opus Dean 's Fund , Marquette University College of Engineering ; ClinicalTrials.gov NCT01795742 . )

###25341682
BACKGROUND	Idiopathic pulmonary fibrosis ( IPF ) is a chronic , devastating , interstitial lung disease , with few therapeutic options .
BACKGROUND	IPF is characterized by pulmonary restriction , dyspnea , hypoxemia , exercise intolerance and poor quality of life ( QOL ) .
OBJECTIVE	We aimed to examine the effect of exercise training ( ET ) on clinical outcomes in IPF patients .
METHODS	A randomized controlled study included thirty-two IPF patients ( aged 68 8 years ) who were allocated either to the ET group ( n = 15 ) , participating in a 12-week , twice-weekly 60-min supervised ET-based pulmonary rehabilitation program , or to a control group ( n = 17 ) continuing with regular medical treatment alone .
METHODS	Cardiopulmonary exercise test , 6-min walking distance ( 6MWD ) test , 30-second chair-stand test , pulmonary function tests , dyspnea and QOL were assessed at baseline and at the end of the 12-week intervention .
RESULTS	Significant differences were observed between the ET and the control groups in raw mean deltas ( = post - - pre-intervention ) : 6MWD , 81 m , p < 0.001 ; VO2 peak , 2.6 ml/kg/min , p = 0.002 ; work rate , 22 W , p < 0.001 ; anaerobic threshold , 3.1 ml/kg/min , p < 0.001 , and FVC % predicted , 6 % , p = 0.038 .
RESULTS	Dyspnea , QOL and 30-second chair-stand were also improved significantly following the program .
CONCLUSIONS	ET improves exercise tolerance , functional capacity , pulmonary function , dyspnea and QOL in patients with IPF , suggesting a short-term treatment efficacy for clinical improvement , and should be considered the standard care for IPF .

###25151920
BACKGROUND	There is concern regarding the administration of iodinated contrast to patients with impaired renal function because of the increased risk of contrast-induced nephropathy .
OBJECTIVE	Evaluate image quality and feasibility of a protocol with a reduced volume of iodinated contrast and utilization of dual-energy coronary CT angiography ( DECT ) vs a standard iodinated contrast volume coronary CT angiography protocol ( SCCTA ) .
METHODS	A total of 102 consecutive patients were randomized to SCCTA ( n = 53 ) or DECT with rapid kVp switching ( n = 49 ) .
METHODS	Eighty milliliters and 35 mL of iodinated contrast were administered in the SCCTA and DECT cohorts , respectively .
METHODS	Two readers measured signal and noise in the coronary arteries ; signal-to-noise ratio ( SNR ) and contrast-to-noise ratio ( CNR ) were calculated .
METHODS	A 5-point signal/noise Likert scale was used to evaluate image quality ; scores of < 3 were nondiagnostic .
METHODS	Agreement was assessed through kappa analyses .
RESULTS	Demographics and radiation dose were not significantly different ; there was no difference in CNR between both cohorts ( P = .95 ) .
RESULTS	A significant difference in SNR between the groups ( P = .02 ) lost significance ( P = .13 ) when adjusted for body mass index .
RESULTS	The median Likert score was inferior for DECT for reader 1 ( 3.6 0.6 vs 4.3 0.6 ; P < .001 ) but not reader 2 ( 4.1 0.6 vs 4.3 0.5 ; P = .06 ) .
RESULTS	Agreement in diagnostic interpretability in the DECT and SCCTA groups was 91 % ( 95 % confidence interval , 86 % -100 % ) and 96 % ( 95 % confidence interval , 90 % -100 % ) , respectively .
CONCLUSIONS	DECT resulted in inferior image quality scores but demonstrated comparable SNR , CNR , and rate of diagnostic interpretability without a radiation dose penalty while allowing for > 50 % reduction in contrast volume compared with SCCTA .

###24971661
BACKGROUND	Myostatin is a negative regulator of muscle growth .
BACKGROUND	Androgen deprivation ( ADT ) is associated with muscle loss and increased body fat , and currently available therapies have limited efficacy to treat this complication .
BACKGROUND	The antimyostatin peptibody ( AMG 745/Mu-S ) markedly attenuated muscle loss and decreased fat accumulation in orchiectomized mice .
OBJECTIVE	The objective of the study was to evaluate the safety , pharmacokinetics , and muscle efficacy of AMG 745 in men undergoing ADT for nonmetastatic prostate cancer .
METHODS	This was a randomized , blinded , placebo-controlled , multiple-dose , phase 1 study of AMG 745 given for 28 days .
METHODS	The end point of percentage change from baseline in lean body mass ( LBM ) as assessed by dual x-ray absorptiometry was prespecified .
RESULTS	Rates of adverse events ( AMG 745 vs placebo ) were the following : diarrhea ( 13 % vs 9 % ) , fatigue ( 13 % vs 4 % ) , contusion ( 10 % vs 0 % ) , and injection site bruising ( 6 % vs 4 % ) .
RESULTS	Exposure increased linearly from 0.3 mg/kg to 3 mg/kg .
RESULTS	AMG 745 significantly increased LBM in the 3 mg/kg vs the placebo groups on day 29 by 2.2 % ( 0.8 % SE , P = 0.008 ) ; in exploratory fat mass analysis , a decrease of -2.5 % ( 1.0 % SE , P = 0.021 ) was observed .
RESULTS	Pharmacodynamic changes in muscle and fat were maintained at follow-up , 1 month after day 29 .
CONCLUSIONS	Four weekly s.c. doses of AMG 745 were well tolerated and were associated with increased LBM and decreased fat in the men receiving ADT for nonmetastatic prostate cancer .
CONCLUSIONS	RESULTS support further investigation of AMG 745 in clinical settings with muscle loss and atrophy .

###25240630
OBJECTIVE	To evaluate the efficacy of a single intravitreal injection of ocriplasmin 125 g across relevant subpopulations of patients with symptomatic vitreomacular adhesion ( VMA ) / vitreomacular traction ( VMT ) , including when associated with macular hole .
METHODS	Two multicenter , randomized , placebo-controlled , double-masked , 6-month studies .
METHODS	A total of 652 randomized patients ( 464 receiving ocriplasmin ; 188 receiving placebo ) .
METHODS	A single intravitreal injection of ocriplasmin 125 g or placebo in the study eye .
METHODS	Prespecified subgroup analyses were conducted to evaluate the effects on the proportion of patients with nonsurgical resolution of focal VMA at day 28 , nonsurgical full-thickness macular hole ( FTMH ) closure at month 6 , and categoric improvement in best-corrected visual acuity ( BCVA ) at month 6 .
RESULTS	Resolution of VMA at day 28 was achieved more often in younger patients ( < 65 years ) , eyes without epiretinal membrane , eyes with FTMH , phakic eyes , and eyes with a focal VMA 1500 m. Eyes with FTMH width 250 m were more likely to achieve nonsurgical FTMH closure .
RESULTS	Categoric 2-line and 3-line improvement in BCVA occurred more often in younger patients ( < 65 years ) and in patients with a lower baseline BCVA ( < 65 letters ) .
RESULTS	Treatment differences in favor of ocriplasmin were generally observed across each subgroup of subpopulations studied .
CONCLUSIONS	Subgroup analyses confirmed the positive effect of ocriplasmin across relevant subpopulations .

###25245213
BACKGROUND	Unhealthy dietary behaviours are one of the key risk factors for many lifestyle-related diseases worldwide .
BACKGROUND	This randomised controlled trial aimed to increase the level of fruit , vegetable and fibre intake and decrease the fat and sugar consumption of mothers with young children ( 0-5 years ) via the playgroup setting .
METHODS	Playgroups located in 60 neighbourhoods in Perth , Western Australia were randomly assigned to an intervention ( n = 249 ) or control group ( n = 272 ) .
METHODS	Those in the intervention group received a 6-month multi-strategy primarily home-based physical activity and nutrition program ( data is only presented on dietary behaviours ) .
METHODS	Data on dietary consumption was collected via the Fat and Fibre Barometer and frequency of serves of fruit and vegetable and cups of soft drink , flavoured drink and fruit juice .
METHODS	The effects of the intervention on continuous outcome measures were assessed using analysis of variance ( ANOVA ) , after adjusting for mother 's age and the corresponding variables .
RESULTS	The outcomes of the intervention were positive with the intervention group showing statistically significant improvements , when compared to the control group in the overall consumption of fat and fibre ( p < 0.0005 ) ; of fibre ( p < 0.0005 ) - fruit and vegetables ( p < 0.0005 ) , wholegrain ( p = 0.002 ) : and fat ( p = 0.005 ) - dairy products ( p = 0.006 ) and lean meat and chicken ( p = 0.041 ) .
RESULTS	There were no significant changes in the consumption of sweet drinks .
CONCLUSIONS	This intervention was successful in improving dietary intake in the intervention group participants .
CONCLUSIONS	The moderate positive outcomes indicate that playgroups potentially provide quite a viable setting to recruit , engage and retain this hard to reach group of mothers of young children in programs that support the adoption of health-enhancing behaviours .
CONCLUSIONS	This adds valuable information to this under researched area .
BACKGROUND	Australian and New Zealand Clinical Trials Registry ACTRN12609000718246 .

###25171686
BACKGROUND	Noninvasive positive-pressure ventilation ( NPPV ) using intelligent volume-assured pressure support ( iVAPS ) combines volume - and pressure-preset NPPV and therefore uses a variation of inspiratory positive airway pressures .
OBJECTIVE	The effect of iVAPS on sleep quality in stable hypercapnic patients with chronic obstructive pulmonary disease ( COPD ) has not been determined .
METHODS	In this randomized , open-label , two-treatment , two-period , crossover study , patients were randomized to receive high-intensity ( HI ) - NPPV and then iVAPS or iVAPS and then HI-NPPV .
METHODS	Patients were studied in hospital for 2 consecutive nights , employing full polysomnography ( PSG ) , transcutaneous partial pressure of CO2 ( PtcCO2 ) monitoring , blood gas analysis and a visual analog scale ( VAS ) - based sleep questionnaire .
METHODS	After discharge , patients used HI-NPPV and iVAPS at home , each for 6 weeks .
METHODS	They had to answer a VAS question concerning sleep every morning , and were telephoned weekly and asked additional questions .
METHODS	At the end of each treatment period , they were visited at home for the determination of blood gases and treatment adherence , and to change the NPPV mode .
RESULTS	Fourteen patients were enrolled .
RESULTS	In-hospital PSG measurements showed no difference in sleep quality between iVAPS and HI-NPPV .
RESULTS	At home , patients reported more restful sleep during iVAPS than HI-NPPV ( p = 0.04 ) .
RESULTS	Blood gases during spontaneous breathing at home did not differ with iVAPS and HI-NPPV , and there was a greater decrease in PtcCO2 during iVAPS than during HI-NPPV ( p = 0.003 ) .
CONCLUSIONS	Although sleep quality in hospital was not different between iVAPS and HI-NPPV , COPD patients with chronic hypercapnic respiratory failure reported a trend towards more restful sleep at home with iVAPS .
CONCLUSIONS	In addition , nocturnal hypercapnia was effectively treated with iVAPS .

###24225205
BACKGROUND	As the population ages , the relative and absolute number of age-associated diseases such as dementia will increase .
BACKGROUND	Evaluation of the suitability and intake of medication and pharmacological treatment is an important aspect of care for people with dementia , especially if they live at home .
BACKGROUND	Regular medication reviews and systematic cooperation between physicians and pharmacists are not common in routine care .
BACKGROUND	Medication management ( MM ) , based on such a comprehensive home medication review could help to reduce drug-related problems and costs .
BACKGROUND	The present article presents a medication management specifically for the application in the ambulatory setting and describes its implementation as part of a larger trial .
METHODS	A home medication review ( HMR ) and MM is implemented as part of the DelpHi study , a population based prospective , cluster-randomized controlled intervention study to test the efficacy and efficiency of the implementation of a collaborative care model in primary care .
METHODS	people with dementia ( PWD ) and their caregivers are recruited by the patient 's general practitioner .
METHODS	Inclusion criteria are a positive screening result for dementia , living at home and regular intake of drugs .
METHODS	PWD are asked to specify their regular pharmacy which is asked to participate in the study , too .
METHODS	a comprehensive HMR is conducted as computer-assisted personal interview by specifically qualified Dementia Care Manager ( DCM ) at the people 's home .
METHODS	It includes detailed information about drugs taken , their storage , administration , adherence and adverse events .
METHODS	The MM is conducted in cooperation between DCM , pharmacist and general practitioner and consists of a pharmaceutical evaluation , pharmaceutical recommendations and their application .
METHODS	Pharmacists are trained and provided with regularly updated information .
METHODS	The MM is designed to give information and recommendations concerning antidementia drugs , occurrence of drug related problems , intake of anticholinergic drugs , potentially clinically relevant drug-drug-interactions , adverse drug events and medication adherence .
CONCLUSIONS	The DelpHi-approach for medication management employs comprehensive instruments and procedures in the primary care setting under routine care conditions , and this approach should be useful in improving pharmacotherapy as part of the comprehensive treatment and care for people with dementia .
BACKGROUND	The trial is registered at ClinicalTrials.gov , number NCT01401582 .

###25397860
BACKGROUND	Currently , there are over 400 smoking cessation smartphone apps available , downloaded an estimated 780,000 times per month .
BACKGROUND	No prior studies have examined how individuals engage with specific features of cessation apps and whether use of these features is associated with quitting .
OBJECTIVE	Using data from a pilot trial of a novel smoking cessation app , we examined : ( i ) the 10 most-used app features , and ( ii ) prospective associations between feature usage and quitting .
METHODS	Participants ( n = 76 ) were from the experimental arm of a randomized , controlled pilot trial of an app for smoking cessation called `` SmartQuit , '' which includes elements of both Acceptance and Commitment Therapy ( ACT ) and traditional cognitive behavioral therapy ( CBT ) .
METHODS	Utilization data were automatically tracked during the 8-week treatment phase .
METHODS	Thirty-day point prevalence smoking abstinence was assessed at 60-day follow-up .
RESULTS	The most-used features - quit plan , tracking , progress , and sharing - were mostly CBT .
RESULTS	Only two of the 10 most-used features were prospectively associated with quitting : viewing the quit plan ( p = 0.03 ) and tracking practice of letting urges pass ( p = 0.03 ) .
RESULTS	Tracking ACT skill practice was used by fewer participants ( n = 43 ) but was associated with cessation ( p = 0.01 ) .
CONCLUSIONS	In this exploratory analysis without control for multiple comparisons , viewing a quit plan ( CBT ) as well as tracking practice of letting urges pass ( ACT ) were both appealing to app users and associated with successful quitting .
CONCLUSIONS	Aside from these features , there was little overlap between a feature 's popularity and its prospective association with quitting .
CONCLUSIONS	Tests of causal associations between feature usage and smoking cessation are now needed .

###25916220
OBJECTIVE	This multicenter , phase 3 trial evaluated oral lubiprostone for constipation associated with non-methadone opioids in patients with chronic noncancer-related pain .
METHODS	Adults with opioid-induced constipation ( OIC ; < 3 spontaneous bowel movements [ SBMs ] per week ) were randomized 1:1 to double-blind lubiprostone 24g or placebo twice daily for 12 weeks .
METHODS	The primary end point was the overall SBM response rate .
METHODS	Responders had at least moderate response ( 1 SBM improvement over baseline frequency ) in all treatment weeks with available observed data , as well as full response ( 3 SBMs per week ) for at least 9 of the 12 treatment weeks .
RESULTS	In total , 431 patients were randomized ; 212 each received lubiprostone and placebo , and 7 were not treated .
RESULTS	Overall , the SBM response rate was significantly higher for patients treated with lubiprostone vs. placebo ( 27.1 vs. 18.9 % , respectively ; P = 0.030 ) .
RESULTS	Overall mean change from baseline in SBM frequency was significantly greater with lubiprostone vs. placebo ( 3.2 vs. 2.4 , respectively ; P = 0.001 ) .
RESULTS	The median time to first SBM was significantly shorter with lubiprostone vs. placebo ( 23.5 vs. 37.7 h , respectively ; P = 0.004 ) .
RESULTS	Compared with placebo , the patients treated with lubiprostone exhibited significant improvements in straining ( P = 0.004 ) , stool consistency ( P < 0.001 ) , and constipation severity ( P = 0.010 ) .
RESULTS	No significant differences were observed in quality-of-life measures or the use of rescue medication ; however , the percentage of patients who used rescue medication was consistently lower in the lubiprostone group than in the placebo group at months 1 ( 34.9 vs. 37.7 % ) , 2 ( 23.4 vs. 26.6 % ) , and 3 ( 20.5 vs. 22.0 % ) .
RESULTS	Adverse events ( AEs ) > 5 % were diarrhea , nausea , vomiting , and abdominal pain ( lubiprostone : 11.3 , 9.9 , 4.2 , and 7.1 % , respectively ; placebo , 3.8 , 4.7 , 5.2 , and 0 % , respectively ) .
RESULTS	None of the serious AEs ( lubiprostone , 3.3 % ; placebo , 2.8 % ) were related to lubiprostone .
CONCLUSIONS	Lubiprostone significantly improved symptoms of OIC and was well tolerated in patients with chronic noncancer pain .

###24399630
BACKGROUND	Strength training and neuromuscular electrical stimulation ( NMES ) improve lower-limb muscle function in dyspnoeic individuals with chronic obstructive pulmonary disease ( COPD ) .
BACKGROUND	However , high-frequency NMES ( HF-NMES ) and strength training have never been compared head-to-head ; and effects of low-frequency NMES ( LF-NMES ) have never been studied in COPD .
BACKGROUND	Therefore , the optimal training modality to improve lower-limb muscle function , exercise performance and other patient-related outcomes in individuals with severe COPD remains unknown .
OBJECTIVE	To study prospectively the efficacy of HF-NMES ( 75Hz ) , LF-NMES ( 15Hz ) or strength training in severely dyspnoeic individuals with COPD with quadriceps muscle weakness at baseline .
METHODS	120 individuals with COPD ( FEV1 : 331 % predicted , men : 52 % , age : 64.80.8 years ) were randomised to HF-NMES , LF-NMES or strength training as part of a comprehensive inpatient pulmonary rehabilitation programme .
METHODS	No treadmill walking or stationary cycling was provided .
RESULTS	Groups were comparable at baseline .
RESULTS	Quadriceps muscle strength increased after HF-NMES ( +10.8 Newton-metre ( Nm ) ) or strength training ( +6.1 Nm ; both p < 0.01 ) , but not after LF-NMES ( +1.4 Nm ; p = 0.43 ) .
RESULTS	Quadriceps muscle endurance , exercise performance , lower-limb fat-free mass , exercise-induced symptoms of dyspnoea and fatigue improved significantly compared with baseline after HF-NMES , LF-NMES or strength training .
RESULTS	The increase in quadriceps muscle strength and muscle endurance was greater after HF-NMES than after LF-NMES .
CONCLUSIONS	HF-NMES is equally effective as strength training in severely dyspnoeic individuals with COPD and muscle weakness in strengthening the quadriceps muscles and thus may be a good alternative in this particular group of patients .
CONCLUSIONS	HF-NMES , LF-NMES and strength training were effective in improving exercise performance in severely dyspnoeic individuals with COPD and quadriceps weakness .
BACKGROUND	NTR2322 .

###25902844
BACKGROUND	Ready-to-use therapeutic foods ( RUTF ) are lipid-based pastes widely used in the treatment of acute malnutrition .
BACKGROUND	Current specifications for RUTF permit a high n-6 polyunsaturated fatty acid ( PUFA ) content and low n-3 PUFA , with no stipulated requirements for preformed long-chain n-3 PUFA .
BACKGROUND	The objective of this study was to develop an RUTF with elevated short-chain n-3 PUFA and measure its impact , with and without fish oil supplementation , on children 's PUFA status during treatment of severe acute malnutrition .
METHODS	This randomized controlled trial in children with severe acute malnutrition in rural Kenya included 60 children aged 6 to 50 months who were randomized to receive i ) RUTF with standard composition ; ii ) RUTF with elevated short chain n-3 PUFA ; or iii ) RUTF with elevated short chain n-3 PUFA plus fish oil capsules .
METHODS	Participants were followed-up for 3 months .
METHODS	The primary outcome was erythrocyte PUFA composition .
RESULTS	Erythrocyte docosahexaenoic acid ( DHA ) content declined from baseline in the two arms not receiving fish oil .
RESULTS	Erythrocyte long-chain n-3 PUFA content following treatment was significantly higher for participants in the arm receiving fish oil than for those in the arms receiving RUTF with elevated short chain n-3 PUFA or standard RUTF alone : 3 months after enrollment , DHA content was 6.3 % ( interquartile range 6.0-7 .3 ) , 4.5 % ( 3.9-4 .9 ) , and 3.9 % ( 2.4-5 .7 ) of total erythrocyte fatty acids ( P < 0.001 ) , respectively , while eicosapentaenoic acid ( EPA ) content was 2.0 % ( 1.5-2 .6 ) , 0.7 % ( 0.6-0 .8 ) , and 0.4 % ( 0.3-0 .5 ) ( P < 0.001 ) .
RESULTS	RUTF with elevated short chain n-3 PUFA and fish oil capsules were acceptable to participants and carers , and there were no significant differences in safety outcomes .
CONCLUSIONS	PUFA requirements of children with SAM are not met by current formulations of RUTF , or by an RUTF with elevated short-chain n-3 PUFA without additional preformed long-chain n-3 PUFA .
CONCLUSIONS	Clinical and growth implications of revised formulations need to be addressed in large clinical trials .
BACKGROUND	Clinicaltrials.gov NCT01593969 .
BACKGROUND	Registered 4 May 2012 .

###24646819
BACKGROUND	Recent studies have reported beneficial effects of probiotics on maternal glycemia in healthy pregnant women .
BACKGROUND	Obesity significantly increases risk of impaired glucose tolerance in pregnancy , but glycemic effects of probiotics in this specific obstetric group require additional investigation .
OBJECTIVE	The aim of the Probiotics in Pregnancy Study was to investigate the effect of a probiotic capsule on maternal fasting glucose in obese pregnant women .
METHODS	In this placebo-controlled , double-blind , randomized trial , 175 pregnant women with an early pregnancy body mass index ( BMI ; in kg/m ) from 30.0 to 39.9 were recruited from antenatal clinics at the National Maternity Hospital , Dublin , Ireland .
METHODS	Exclusion criteria were BMI < 30.0 or > 39.9 , prepregnancy or gestational diabetes , age < 18 y , multiple pregnancy , and fetal anomaly .
METHODS	Women were randomly assigned to receive either a daily probiotic or a placebo capsule from 24 to 28 wk of gestation in addition to routine antenatal care .
METHODS	The primary outcome was the change in fasting glucose between groups from preintervention to postintervention .
METHODS	Secondary outcomes were the incidence of gestational diabetes and neonatal anthropometric measures .
RESULTS	In 138 women who completed the study ( 63 women in the probiotic group ; 75 women in the placebo group ) , mean ( SD ) early pregnancy BMI was 33.6 2.6 , which differed significantly between probiotic ( 32.9 2.4 ) and placebo ( 34.1 2.7 ) groups .
RESULTS	With adjustment for BMI , the change in maternal fasting glucose did not differ significantly between treated and control groups [ -0.09 0.27 compared with -0.07 0.39 mmol/L ; P = 0.391 ; B = -0.05 ( 95 % CI : -0.17 , 0.07 ) ] .
RESULTS	There were also no differences in the incidence of impaired glycemia ( 16 % in the probiotic group compared with 15 % in the placebo group ; P = 0.561 ) , birth weight ( 3.70 kg in the probiotic group compared with 3.68 kg in the placebo group ; P = 0.723 ) , or other metabolic variables or pregnancy outcomes .
RESULTS	A secondary analysis of 110 women , excluding antibiotic users and poor compliers , also revealed no differences in maternal glucose or other outcomes between groups .
CONCLUSIONS	Probiotic treatment of 4 wk during pregnancy did not influence maternal fasting glucose , the metabolic profile , or pregnancy outcomes in obese women .

###24405160
BACKGROUND	Employment has been identified as an important part of substance abuse treatment and is a predictor of treatment retention , treatment completion , and decreased relapse .
BACKGROUND	Although employment interventions have been designed for substance abusers , few interventions have focused specifically on drug-involved offenders .
OBJECTIVE	The purpose of this study was to examine employment outcomes for drug-involved offenders who received a tailored employment intervention .
METHODS	In a randomized controlled trial , baseline and follow-up data were collected from 500 drug-involved offenders who were enrolled in a drug court program .
METHODS	Participants were randomly assigned to drug court as usual ( control group ) or to the employment intervention in addition to drug court .
RESULTS	Intent-to-treat analyses found that the tailored intervention was associated only with more days of paid employment at follow-up ( 210.1 vs. 199.9 days ) .
RESULTS	When focusing on those with greater employment assistance needs , a work trajectory analyses , which took into account participants ' pre-baseline employment pattern ( negative or positive ) , revealed that intervention group participants had higher rates of employment ( 82.1 % vs. 64.1 % ) , more days paid for employment ( 188.9 vs. 157.0 days ) , and more employment income ( $ 8623 vs. $ 6888 ) at follow-up than control group participants .
CONCLUSIONS	The present study adds to the growing substance abuse and employment literature .
CONCLUSIONS	It demonstrates the efficacy of an innovative employment intervention tailored for drug-involved offenders by showing positive changes in 12-month employment outcomes , most strongly for those who have not had recent employment success .

###25619518
BACKGROUND	Reported response rates of transitional cell carcinoma ( TCC ) in dogs to piroxicam in combination with either mitoxantrone or carboplatin are similar ; however , it is unknown whether either drug might provide superior duration of response .
OBJECTIVE	To determine if the progression-free interval ( PFI ) of dogs with TCC treated with mitoxantrone and piroxicam was different than that of dogs receiving carboplatin and piroxicam .
OBJECTIVE	The hypothesis was that the efficacy of mitoxantrone is no different from carboplatin .
METHODS	Fifty dogs with TCC without azotemia .
METHODS	Prospective open-label phase III randomized study .
METHODS	Either mitoxantrone or carboplatin was administered every 3 weeks concurrently with piroxicam with restaging at 6-week intervals .
METHODS	Twenty-four dogs received carboplatin and 26 received mitoxantrone .
RESULTS	Response was not different between groups ( P = .56 ) .
RESULTS	None of the dogs showed complete response .
RESULTS	In the mitoxantrone group , there were 2 ( 8 % ) partial responses ( PR ) and 18 ( 69 % ) dogs with stable disease ( SD ) .
RESULTS	In the carboplatin group , there were 3 PR ( 13 % ) and 13 ( 54 % ) dogs with SD .
RESULTS	The PFI was not significantly different between groups ( mitoxantrone = 106 days ; carboplatin = 73.5 days ; P = .62 ; hazard ratio 0.86 ; 95 % confidence interval 0.47-1 .56 ) .
RESULTS	Dogs with prostatic involvement experienced a shorter survival ( median , 109 days ) compared to dogs with urethral , trigonal , or apically located tumors ; this difference was significant ( median 300 , 190 , and 645 days , respectively ; P = .005 ) .
CONCLUSIONS	This study did not detect a different in outcome in dogs with TCC treated with either mitoxantrone or carboplatin in combination with piroxicam .

###25322766
BACKGROUND	Computerized decision support systems ( CDSSs ) are increasingly used to improve quality of care .
BACKGROUND	There is evidence for moderate to large effects from randomized controlled trials ( RCTs ) , but evidence on their effectiveness when implemented at a national level is lacking .
BACKGROUND	In the Netherlands , the Dutch College of General Practitioners ( NHG ) initiated their successful guideline program already 30years ago .
BACKGROUND	NHGDoc , a CDSS based on these NHG guidelines , covering multiple disease areas for general practice , was developed in 2006 with the aim to improve quality of primary care .
BACKGROUND	In this paper , a protocol is presented to evaluate the uptake and effects of NHGDoc .
METHODS	A cluster RCT will be conducted among 120 general practices in the Netherlands .
METHODS	Eligible general practices will be randomized to receive either the regular NHGDoc decision support modules ( control arm ) or the regular modules plus an additional module on heart failure ( intervention arm ) .
METHODS	The heart failure module consists of patient-specific alerts concerning the treatment of patients with heart failure .
METHODS	The effect evaluation will focus on performance indicators ( e.g. , prescription behavior ) as well as on patient outcomes ( e.g. , hospital admissions ) relevant in the domain of heart failure .
METHODS	Additionally , a process evaluation will be conducted to gain insight into the barriers and facilitators that affect the uptake and impact of NHGDoc .
CONCLUSIONS	Results of this study will provide insight in the uptake and impact of a multiple-domain covering CDSS for primary care implemented by a national guideline organization to improve the quality of primary care .
CONCLUSIONS	Whereas the trial focuses on a specific domain of care-heart failure-conclusions of this study will shed light on the functioning of CDSSs covering multiple disease areas for primary care , particularly as this study also explores the factors contributing to the system 's uptake and effectiveness .
BACKGROUND	Clinical trials NCT01773057 .

###25188488
OBJECTIVE	The purpose of this study was to compare the utility of 2 surgical models for obstetric anal sphincter repair for improving resident knowledge , confidence level , and repair technique .
METHODS	Third - and fourth-year obstetrics and gynecology residents at LAC + USC Medical Center performed simulated anal sphincter repair on both sponge and beef tongue surgical models .
METHODS	Resident knowledge , confidence , technical skill , and preference were assessed after each model was performed .
RESULTS	Both models significantly improved resident confidence ( sponge , P = 0.017 ; tongue , P = 0.016 ) and knowledge ( 60 % correct before intervention vs. 92 % correct after intervention , P < 0.001 ) .
RESULTS	There was no difference detected between the 2 models .
RESULTS	All participants preferred the tongue model to the sponge model .
RESULTS	When performing both models , performing the tongue model after the sponge model resulted in a further increase in confidence ( P = 0.008 ) CONCLUSIONS : Both models are excellent tools to aid in resident teaching of obstetric anal sphincter repair and significantly increase residents ' knowledge and confidence .

###25233157
OBJECTIVE	The purpose of this study was to determine whether the SPRINT definition of a `` critical-sized defect '' ( fracture gap at least 1 cm in length and involving over 50 % of the cortical diameter ) was accurate , to discern which factors predict reoperation in patients with these defects , and to compare the patient-based outcomes of these patients with patients without a critical defect .
METHODS	Therapeutic Cohort Study .
METHODS	Level 1 and level 2 trauma centers .
METHODS	Thirty-seven patients in the SPRINT trial with a critical-sized defect participated .
METHODS	We evaluated these patients for planned and unplanned secondary intervention to gain union .
METHODS	Additionally , we evaluated which other factors predicted the need for reoperation .
METHODS	Finally , the 37 patients with a critical defect were compared with the larger cohort of patients without a defect with respect to demographics , mechanism of injury , fracture characteristics , and patient-based outcome .
METHODS	Revision surgery for tibial nonunion .
RESULTS	Of the 37 patients with a large fracture gap , 7 patients had a planned secondary procedure .
RESULTS	Of the remaining 30 patients in whom the attending surgeon adopted a `` watch and wait '' strategy , 14 patients ( 47 % ) never required additional surgery to gain union .
RESULTS	Additional surgery to gain union was less likely in patients treated with a reamed nail ( P = 0.04 ) and in female patients ( P = 0.04 ) .
RESULTS	Patients with a critical-sized defect were more likely to have a high-energy mechanism of injury ( P = 0.001 ) , AO-OTA fracture type 42 B or C ( P < 0.001 ) , and location involving the middle third of the tibia ( P = 0.02 ) .
RESULTS	The 12-month SF-36 physical component summary score in patients with a critical-sized defect was 38.2 10.5 ( mean SD ) compared with 43.3 10.7 in those without a critical defect ( P = 0.02 , difference = 5.2 , 95 % confidence interval = 0.8-9 .6 ) .
CONCLUSIONS	Tibial diaphyseal defects of > 1 cm and > 50 % cortical circumference healed without additional surgery in 47 % of cases .
CONCLUSIONS	This definition of a critical-sized defect is not `` critical . ''
CONCLUSIONS	However , as compared with the overall cohort of tibial fractures , patients with these bone defects had a higher rate of reoperation and worse patient-based outcomes .
CONCLUSIONS	Further investigation is required to determine which factors predict union in this challenging fracture to avoid unnecessary secondary surgery .
METHODS	Prognostic level I. See instructions for authors for a complete description of levels of evidence .

###24467802
BACKGROUND	Overweight and obesity are associated with an increased risk of morbidity .
BACKGROUND	Mindfulness training could be an effective strategy to optimize lifestyle behaviors related to body weight gain .
BACKGROUND	The aim of this study was to evaluate the effectiveness of a worksite mindfulness-based multi-component intervention on vigorous physical activity in leisure time , sedentary behavior at work , fruit intake and determinants of these behaviors .
BACKGROUND	The control group received information on existing lifestyle behavior - related facilities that were already available at the worksite .
METHODS	In a randomized controlled trial design ( n = 257 ) , 129 workers received a mindfulness training , followed by e-coaching , lunch walking routes and fruit .
METHODS	Outcome measures were assessed at baseline and after 6 and 12 months using questionnaires .
METHODS	Physical activity was also measured using accelerometers .
METHODS	Effects were analyzed using linear mixed effect models according to the intention-to-treat principle .
METHODS	Linear regression models ( complete case analyses ) were used as sensitivity analyses .
RESULTS	There were no significant differences in lifestyle behaviors and determinants of these behaviors between the intervention and control group after 6 or 12 months .
RESULTS	The sensitivity analyses showed effect modification for gender in sedentary behavior at work at 6-month follow-up , although the main analyses did not .
CONCLUSIONS	This study did not show an effect of a worksite mindfulness-based multi-component intervention on lifestyle behaviors and behavioral determinants after 6 and 12 months .
CONCLUSIONS	The effectiveness of a worksite mindfulness-based multi-component intervention as a health promotion intervention for all workers could not be established .

###25103148
OBJECTIVE	Intralesional antigen therapy has been used in the treatment of anogenital warts ( AGWs ) , but it has not been compared with existing therapies .
OBJECTIVE	Evidence of its efficacy is not strong .
OBJECTIVE	To compare the efficacy and safety of intralesional Mycobacterium w ( Mw ) vaccine with that of imiquimod , 5 % , cream in the treatment of AGWs , as well as changes in human papillomavirus ( HPV ) -6 and HPV-11 viral loads .
METHODS	A double-blind randomized clinical trial was conducted in New Delhi , India , between February 2009 and July 2012 and included a 3-month follow-up .
METHODS	Of 159 patients with AGWs who were screened , 89 were randomized .
METHODS	Patients received either imiquimod , 5 % , cream and an intralesional vehicle ( imiquimod group : 44 patients ) or vehicle cream and intralesional Mw vaccine ( Mw group : 45 patients ) .
METHODS	The primary end point was complete clinical remission of visible AGWs .
METHODS	Secondary measures included the percentage of reduction in the surface area of AGWs and viral load for HPV-6 and HPV-11 .
METHODS	Viral load was measured by real-time quantitative polymerase chain reaction .
RESULTS	In the intention-to-treat analysis , 59 % ( n = 26 ) of the patients in the imiquimod group and 67 % ( n = 30 ) of those in the Mw group had complete resolution ( P = .52 ) .
RESULTS	Eighteen HPV genotypes , including high-risk genotypes , were detected , with no significant differences between the treatment groups ( all P > .05 ) .
RESULTS	There was a significant decline in the mean viral loads of HPV-6 ( from 0.011108 to 0.00000154108 copies/mg of tissue ; P = .003 ) and HPV-11 ( from 0.121108 to 0.017108 copies/mg of tissue ; P = .03 ) after treatment in the Mw group but only in the viral load of HPV-6 ( from 1.41108 to 0.004108 copies/mg of tissue ; P = .01 ) in the imiquimod group .
RESULTS	There was no recurrence of AGWs in patients with complete clearance at the 3-month follow-up and no serious adverse events .
CONCLUSIONS	Imiquimod , 5 % , and the Mw vaccine were equally effective in achieving clinical and virologic clearance for HPV-6 .
CONCLUSIONS	A significant decline in the HPV-11 viral load was achieved only with the Mw vaccine .
CONCLUSIONS	Efficacy and safety of intralesional Mw vaccine is comparable to that of imiquimod , 5 % , in treatment of AGWs .
BACKGROUND	ctri.nic.in Identifier : CTRI/2009/091 / 000055 .

###24694769
BACKGROUND	The present study investigated whether cilostazol can eliminate adverse smoking outcome after percutaneous coronary intervention ( PCI ) .
RESULTS	A total of 914 patients with successful drug-eluting stent ( DES ) implantation were randomly assigned to dual antiplatelet therapy ( DAT ; aspirin and clopidogrel , n = 457 ) or to triple antiplatelet therapy ( TAT ; DAT with cilostazol , n = 457 ) .
RESULTS	The effect of smoking on 2-year major adverse cardio/cerebrovascular events ( MACCE ) in both the TAT and DAT groups was evaluated .
RESULTS	Total MACCE were not significantly different between the 2 anti-platelet regimens ( 9.8 % in TAT vs. 11.4 % in DAT groups , P = 0.45 ) , but the adverse effects of smoking on clinical outcome were different between DAT vs. TAT .
RESULTS	Current smokers had a higher prevalence of MACCE than non-smokers in the DAT group ( 16.7 % vs. 9.5 % , P = 0.04 ) .
RESULTS	In the TAT group , however , the adverse effect of smoking was abolished ( 9.2 % vs. 10.1 % , P = 0.85 ) .
RESULTS	Regarding the effects of smoking on the antiplatelet effects of DAT or TAT , post-treatment platelet reactivity ( in P2Y12 reaction units ; PRU ) in current smokers was not significantly lower than that in non-smokers in the DAT group , whereas , in the TAT group , it was significantly lower than that of non-smokers ( 18988 vs. 21689 PRU , P = 0.01 ) .
CONCLUSIONS	Adverse clinical effects of smoking may be eliminated by the addition of cilostazol to DAT after DES implantation .
CONCLUSIONS	This may be due to the stimulation of cilostazol 's antiplatelet effects by smoking .

###24730575
OBJECTIVE	The purpose of this study was to test the comparative effectiveness of three variations of an online-based health promotion program for improving health and employment outcomes in a sample of Vocational Rehabilitation consumers .
METHODS	A total of 222 VR consumers participated in a randomized trial of three health promotion variations and provided baseline , 2 - , 4 - , and 6-month data .
METHODS	Data were analyzed using repeated measures ANOVA .
METHODS	The three health promotion variations included ( a ) FACTSHEETS-a series of four electronic factsheets ; ( b ) HPE-an online interactive health promotion website that included health behavior content and tailored action planning , and ( c ) HPE + MI-the online health promotion website plus two 30-minute calls with a trained motivational interviewer .
RESULTS	Contrary to expectations , evidence did not support between-group differences based on intervention intensity .
RESULTS	In fact , the Factsheet , HPE , and HPE + MI participants all experienced significant reductions in secondary conditions , F ( 2.85 , 489 ) = 7.808 , p < .001 , HRQoL symptom days , F ( 2.7 , 495 ) = 4.795 , p = .004 ; and significant improvements in healthy lifestyle behaviors , F ( 2.6 , 495 ) = 3.66 , p = .017 over the 6-month study period .
RESULTS	Although this study did not include a control group , a control group from another study with a similar population did not experience similar outcomes .
CONCLUSIONS	People with disabilities experience significantly higher rates of secondary health conditions and lower employment rates than people without disabilities .
CONCLUSIONS	The combination of these factors signifies the need for health promotion programming outside the work setting .

###24670140
BACKGROUND	Muscle glycogen has been well established as the primary metabolic energy substrate during physical exercise of moderate - to high-intensity and has accordingly been implicated as a limiting factor when such activity is sustained for a prolonged duration .
BACKGROUND	However , the role of this substrate during repeated exercise after limited recovery is less clear , with ongoing debate regarding how recovery processes can best be supported via nutritional intervention .
BACKGROUND	The aim of this project is to examine the causes of fatigue during repeated exercise bouts via manipulation of glycogen availability through nutritional intervention , thus simultaneously informing aspects of the optimal feeding strategy for recovery from prolonged exercise .
METHODS	The project involves two phases with each involving two treatment arms administered in a repeated measures design .
METHODS	For each treatment , participants will be required to exercise to the point of volitional exhaustion on a motorised treadmill at 70 % of previously determined maximal oxygen uptake , before a four hour recovery period in which participants will be prescribed solutions providing 1.2 grams of sucrose per kilogram of body mass per hour of recovery ( g.kg-1 .
METHODS	h-1 ) relative to either a lower rate of sucrose ingestion ( that is , 0.3 g.kg-1 .
METHODS	h-1 ; Phase I ) or a moderate dose ( that is , 0.8 g.kg-1 .
METHODS	h-1 ) rendered isocaloric via the addition of 0.4 g.kg-1 .
METHODS	h-1 whey protein hydrolysate ( Phase II ) ; the latter administered in a double blind manner as part of a randomised and counterbalanced design .
METHODS	Muscle biopsies will be sampled at the beginning and end of recovery for determination of muscle glycogen resynthesis rates , with further biopsies taken following a second bout of exhaustive exercise to determine differences in substrate availability relative to the initial sample taken following the first exercise bout .
CONCLUSIONS	Phase I will inform whether a dose-response relationship exists between carbohydrate ingestion rate and muscle glycogen availability and/or the subsequent capacity for physical exercise .
CONCLUSIONS	Phase II will determine whether such effects are dependent on glycogen availability per se or energy intake , potentially via protein mediated mechanisms .
BACKGROUND	ISRCTN87937960 .

###26209030
BACKGROUND	Case series suggest that laparoscopic peritoneal lavage might be a promising alternative to sigmoidectomy in patients with perforated diverticulitis .
BACKGROUND	We aimed to assess the superiority of laparoscopic lavage compared with sigmoidectomy in patients with purulent perforated diverticulitis , with respect to overall long-term morbidity and mortality .
METHODS	We did a multicentre , parallel-group , randomised , open-label trial in 34 teaching hospitals and eight academic hospitals in Belgium , Italy , and the Netherlands ( the Ladies trial ) .
METHODS	The Ladies trial is split into two groups : the LOLA group comparing laparoscopic lavage with sigmoidectomy and the DIVA group comparing Hartmann 's procedure with sigmoidectomy plus primary anastomosis .
METHODS	The DIVA section of this trial is still underway but here we report the results of the LOLA section .
METHODS	Patients with purulent perforated diverticulitis were enrolled for LOLA , excluding patients with faecal peritonitis , aged older than 85 years , with high-dose steroid use ( 20 mg daily ) , and haemodynamic instability .
METHODS	Patients were randomly assigned ( 2:1:1 ; stratified by age [ < 60 years vs 60 years ] ) using secure online computer randomisation to laparoscopic lavage , Hartmann 's procedure , or primary anastomosis in a parallel design after diagnostic laparoscopy .
METHODS	Patients were analysed according to a modified intention-to-treat principle and were followed up after the index operation at least once in the outpatient setting and after sigmoidoscopy and stoma reversal , according to local protocols .
METHODS	The primary endpoint was a composite endpoint of major morbidity and mortality within 12 months .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01317485 .
RESULTS	Between July 1 , 2010 , and Feb 22 , 2013 , 90 patients were randomly assigned in the LOLA section of the Ladies trial when the study was terminated by the data and safety monitoring board because of an increased event rate in the lavage group .
RESULTS	Two patients were excluded for protocol violations .
RESULTS	The primary endpoint occurred in 30 ( 67 % ) of 45 patients in the lavage group and 25 ( 60 % ) of 42 patients in the sigmoidectomy group ( odds ratio 128 , 95 % CI 054-303 , p = 058 ) .
RESULTS	By 12 months , four patients had died after lavage and six patients had died after sigmoidectomy ( p = 043 ) .
CONCLUSIONS	Laparoscopic lavage is not superior to sigmoidectomy for the treatment of purulent perforated diverticulitis .
BACKGROUND	Netherlands Organisation for Health Research and Development .

###24787564
OBJECTIVE	To compare the laser spot quality between the conventional slit lamp pattern laser ( PASCAL ) and the navigated pattern laser ( NAVILAS ) for panretinal photocoagulation ( PRP ) .
METHODS	Prospective randomized interventional trial of 73 eyes ( 51 patients ) with high-risk proliferative diabetic retinopathy .
METHODS	Eyes underwent PRP using 30-ms pulse duration with either PASCAL ( 16 eyes ) or NAVILAS laser ( 21 eyes ) , or 100-ms pulse duration with either PASCAL ( 16 eyes ) or NAVILAS laser ( 20 eyes ) .
METHODS	Fundus color images of all quadrants were taken 5 minutes after treatment .
METHODS	Laser burn size ( major and minor diameter and area ) and ellipticity ( ratio of minor to major axis ) were analyzed across the retina .
METHODS	Treatment time and pain were compared between both groups .
RESULTS	The burn size variation in navigated laser 30 ms , 100 ms , and conventional pattern 30 ms and single-spot 100 ms laser was 22 % , 24 % , 21 % , and 35 % , respectively .
RESULTS	The variation of the laser burn area near the arcade for NAVILAS and for PASCAL was 29 % and 22 % , respectively ( P < 0.01 ) .
RESULTS	Closer to the equator , burns from the NAVILAS showed even smaller variation of 15 % compared with 25 % with PASCAL ( P < 0.005 ) .
RESULTS	Laser spots from PASCAL exhibited an increasing elliptical shape toward the periphery , whereas NAVILAS laser spots tended to be more uniform all over the retina .
RESULTS	Average treatment duration and pain experience was less with navigated laser compared with pattern laser ( P 0.05 ) .
CONCLUSIONS	Navigated laser treatment achieves more uniform laser burns with less pain during shorter treatment duration in comparison with conventional pattern laser .

###25794220
BACKGROUND	In patients with chronic tension-type headache ( CTTH ) changes in pressure pain in the cervical region are associated with peripheral or central sensitization .
BACKGROUND	It is hypothesized that an increase of isometric strength of neck flexors would lead to a decrease of pressure pain in CTTH , as an expression of reduced peripheral or central sensitization
OBJECTIVE	In this study we aimed to analyze the correlation between change in isometric strength of the neck flexors and change in pressure pain scores ( PPS ) in patients with CTTH .
METHODS	Comparative analysis of data from previous study .
METHODS	Primary healthcare center .
METHODS	Data from 145 patients with CTTH who underwent a manual therapy program including isometric strength training of the neck flexors were analyzed at 8 and 26 weeks post-treatment .
METHODS	PPS were measured as a total of pain scores on a numeric rating scale ( score 0 to 10 ) on application of a pressure stimulus of 3kg/cm at 8 cervical - and suboccipital muscles .
METHODS	Isometric strength of the neck flexors was measured in seconds .
METHODS	Correlations were computed between changes in PPS and isometric neck flexor strength .
RESULTS	Isometric strength of neck flexors scored significantly different compared to baseline measurement ( mean 30.0 seconds , sd :25.2 ) , and increased with a mean difference of 17.33 seconds ( 95 % CI : 20.61 to 14.05 ) at 8 weeks and 19.18 seconds ( 95 % CI : 23.48 to 14.87 ) at 26 weeks .
RESULTS	Similarly , compared to PPS baseline measurement ( 31.6 points , sd :18.6 ) , mean difference in PPS was significantly decreased at 8 and 26 weeks : -11.3 points ( 95 % CI : -8.77 to -13.83 ) and -11.15 points ( 95 % CI : -8.31 to -13.99 ) .
RESULTS	There is a negative correlation between changes in PPS and changes in isometric strength of neck flexors which is weak at 8 weeks ( r = -0.243 , P = 0.004 ) and moderate at 26 weeks ( r = -0.318 , P < 0.000 ) .
CONCLUSIONS	Correlational analysis .
CONCLUSIONS	Decrease in PPS correlates with increases in isometric strength of neck flexors in patients with CTTH in short - and long-term .

###25104523
BACKGROUND	Patients with ischemic left ventricular dysfunction have higher operative risk with coronary artery bypass graft surgery ( CABG ) .
BACKGROUND	However , those whose early risk is surpassed by subsequent survival benefit have not been identified .
OBJECTIVE	This study sought to examine the impact of anatomic variables associated with poor prognosis on the effect of CABG in ischemic cardiomyopathy .
METHODS	All 1,212 patients in the STICH ( Surgical Treatment of IsChemic Heart failure ) surgical revascularization trial were included .
METHODS	Patients had coronary artery disease ( CAD ) and ejection fraction ( EF ) of 35 % and were randomized to receive CABG plus medical therapy or optimal medical therapy ( OMT ) alone .
METHODS	This study focused on 3 prognostic factors : presence of 3-vessel CAD , EF below the median ( 27 % ) , and end-systolic volume index ( ESVI ) above the median ( 79 ml/m ( 2 ) ) .
METHODS	Patients were categorized as having 0 to 1 or 2 to 3 of these factors .
RESULTS	Patients with 2 to 3 prognostic factors ( n = 636 ) had reduced mortality with CABG compared with those who received OMT ( hazard ratio [ HR ] : 0.71 ; 95 % confidence interval [ CI ] : 0.56 to 0.89 ; p = 0.004 ) ; CABG had no such effect in patients with 0 to 1 factor ( HR : 1.08 ; 95 % CI : 0.81 to 1.44 ; p = 0.591 ) .
RESULTS	There was a significant interaction between the number of factors and the effect of CABG on mortality ( p = 0.022 ) .
RESULTS	Although 30-day risk with CABG was higher , a net beneficial effect of CABG relative to OMT was observed at > 2 years in patients with 2 to 3 factors ( HR : 0.53 ; 95 % CI : 0.37 to 0.75 ; p < 0.001 ) but not in those with 0 to 1 factor ( HR : 0.88 ; 95 % CI : 0.59 to 1.31 ; p = 0.535 ) .
CONCLUSIONS	Patients with more advanced ischemic cardiomyopathy receive greater benefit from CABG .
CONCLUSIONS	This supports the indication for surgical revascularization in patients with more extensive CAD and worse myocardial dysfunction and remodeling .
CONCLUSIONS	( Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease [ STICH ] ; NCT00023595 ) .

###24947808
OBJECTIVE	Hypertension and overweight are prevalent problems in type 2 diabetic patients .
OBJECTIVE	The purpose of this study was to assess the effects of long term regular aerobic exercise training on blood pressure ( BP ) as well as body mass index ( BMI ) in type 2 diabetes mellitus ( T2DM ) .
METHODS	In a randomized , controlled trial , 60 patients with T2DM aged 40-65 years were randomly divided in two groups ( 30 subjects in exercise group and 30 subjects in control group ) .
METHODS	Supervised exercise program was performed three times per week for 3 years .
METHODS	Finally , 28 patients who completed the optimal sessions , entered in statistical analysis .
RESULTS	Systolic and diastolic blood pressure ( SBP , DBP ) had no significant changes in control group ( respectively 127.4812.79 to 129.288.52 and 78.908.06 to 77.555.95 ) .
RESULTS	These changes were statistically significant in the exercise group ( respectively 132.5714.82 to 118.0012.48 and 82.899.19 to 74.006.57 ; P < 0.001 ) .
RESULTS	Furthermore , the BMI of exercise group reduced significantly ( 285.26 to 26.424.36 ; P < 0.001 ) in comparison with control group that showed a significant increase in terms of this variable ( 30.024.79 to 31.054.84 ; P < 0.05 ) .
CONCLUSIONS	The present study suggests that long term aerobic exercise has positive effects on systolic and diastolic blood pressure as well as heart rate of T2DM patients .
CONCLUSIONS	We observed significant differences in levels of BMI in two groups after intervention .

###25247709
BACKGROUND	Intermittent preventive treatment in pregnancy ( IPTp ) with sulfadoxine-pyrimethamine ( SP ) is recommended by WHO to prevent malaria in African pregnant women .
BACKGROUND	The spread of SP parasite resistance has raised concerns regarding long-term use for IPT .
BACKGROUND	Mefloquine ( MQ ) is the most promising of available alternatives to SP based on safety profile , long half-life , and high efficacy in Africa .
BACKGROUND	We evaluated the safety and efficacy of MQ for IPTp compared to those of SP in HIV-negative women .
RESULTS	A total of 4,749 pregnant women were enrolled in an open-label randomized clinical trial conducted in Benin , Gabon , Mozambique , and Tanzania comparing two-dose MQ or SP for IPTp and MQ tolerability of two different regimens .
RESULTS	The study arms were : ( 1 ) SP , ( 2 ) single dose MQ ( 15 mg/kg ) , and ( 3 ) split-dose MQ in the context of long lasting insecticide treated nets .
RESULTS	There was no difference on low birth weight prevalence ( primary study outcome ) between groups ( 360/2 ,778 [ 13.0 % ] ) for MQ group and 177/1 ,398 ( 12.7 % ) for SP group ; risk ratio [ RR ] , 1.02 ( 95 % CI 0.86-1 .22 ; p = 0.80 in the ITT analysis ) .
RESULTS	Women receiving MQ had reduced risks of parasitemia ( 63/1 ,372 [ 4.6 % ] in the SP group and 88/2 ,737 [ 3.2 % ] in the MQ group ; RR , 0.70 [ 95 % CI 0.51-0 .96 ] ; p = 0.03 ) and anemia at delivery ( 609/1 ,380 [ 44.1 % ] in the SP group and 1,110 / 2743 [ 40.5 % ] in the MQ group ; RR , 0.92 [ 95 % CI 0.85-0 .99 ] ; p = 0.03 ) , and reduced incidence of clinical malaria ( 96/551 .8 malaria episodes person/year [ PYAR ] in the SP group and 130/1 ,103.2 episodes PYAR in the MQ group ; RR , 0.67 [ 95 % CI 0.52-0 .88 ] ; p = 0.004 ) and all-cause outpatient attendances during pregnancy ( 850/557 .8 outpatients visits PYAR in the SP group and 1,480 / 1,110.1 visits PYAR in the MQ group ; RR , 0.86 [ 0.78-0 .95 ] ; p = 0.003 ) .
RESULTS	There were no differences in the prevalence of placental infection and adverse pregnancy outcomes between groups .
RESULTS	Tolerability was poorer in the two MQ groups compared to SP .
RESULTS	The most frequently reported related adverse events were dizziness ( ranging from 33.9 % to 35.5 % after dose 1 ; and 16.0 % to 20.8 % after dose 2 ) and vomiting ( 30.2 % to 31.7 % , after dose 1 and 15.3 % to 17.4 % after dose 2 ) with similar proportions in the full and split MQ arms .
RESULTS	The open-label design is a limitation of the study that affects mainly the safety assessment .
CONCLUSIONS	Women taking MQ IPTp ( 15 mg/kg ) in the context of long lasting insecticide treated nets had similar prevalence rates of low birth weight as those taking SP IPTp .
CONCLUSIONS	MQ recipients had less clinical malaria than SP recipients , and the pregnancy outcomes and safety profile were similar .
CONCLUSIONS	MQ had poorer tolerability even when splitting the dose over two days .
CONCLUSIONS	These results do not support a change in the current IPTp policy .
BACKGROUND	ClinicalTrials.gov NCT 00811421 ; Pan African Clinical Trials Registry PACTR 2010020001429343 Please see later in the article for the Editors ' Summary .

###24710917
OBJECTIVE	We studied whether suppressed secretion of the orexigenic peptide ghrelin might be involved in the anorexigenic effects of nicotine .
METHODS	Fifty healthy non-smokers chewed gums containing 2mg nicotine , or no nicotine in a double-blind randomised crossover design in two independent studies .
RESULTS	Plasma nonacylated ghrelin was not significantly affected by nicotine after 30 and 60min .
RESULTS	Increased blood pressure and decreased appetite ratings confirmed a biological nicotine effect .
CONCLUSIONS	These results do not support a key role of peripheral ghrelin secretion in weight changes related to smoking or smoking cessation , but do not rule out that central nervous system ghrelin is involved .

###25791056
BACKGROUND	External thermal support is critical for preterm or ill infants due to altered thermoregulation .
BACKGROUND	Incubators are the gold standard for long-term support and have been adopted successfully in many countries .
BACKGROUND	Alternatives such as radiant warmers , blankets and others are often used as standard of care ( SoC ) in resource-limited settings when infants are otherwise not in Kangaroo Mother Care ( KMC ) .
METHODS	In this pilot study , we evaluate the feasibility of a conductive thermal mattress ( CTM ) using phase change materials as a low-cost warmer .
METHODS	We conducted a prospective multicentre open-label randomised controlled trial to determine non-inferiority of this CTM to SoC warming practices in low birthweight infants .
METHODS	The primary outcome was maintenance of axillary temperature .
RESULTS	We equally randomised 160 infants to CTM or SoC .
RESULTS	The latter cohort continued to receive warmth by radiant warmers ( n = 48 ) , blankets ( n = 18 ) , warmed cradles ( n = 7 ) or KMC ( n = 7 ) before , during and subsequent to the study .
RESULTS	CTM was deemed non-inferior since warmed babies had higher axillary temperature compared with SoC ( mean increase 0.110.03 C SEM ; p < 0.001 ) .
RESULTS	Post hoc comparison to radiant warmers alone showed that CTM led to a higher axillary temperature ( mean increase by 0.140.03 C SEM ; p < 0.001 ) .
CONCLUSIONS	Short-term use of CTM compared with radiant warmers and other modes of warming is non-inferior to SoC and efficacious in maintaining body temperature .
CONCLUSIONS	No adverse effects were reported .
CONCLUSIONS	An extended multinational trial , preferably one that demonstrates longer-term thermoregulation , is warranted .
BACKGROUND	Clinical Trials Registry of India ( CTRI/2010/091 / 002916 and CTRI/2011/04 / 001696 ) .

###24450608
BACKGROUND	Schizophrenia is one of the most serious forms of mental illness among people being treated in psychiatric clinics in developing and developed countries .
BACKGROUND	Providing care for people diagnosed with schizophrenia can be stressful for their caregivers .
BACKGROUND	Psycho-educational interventions may improve patients ' and primary caregivers ' knowledge of schizophrenia and impact positively on patients ' physical and psychological outcomes and primary caregivers ' burden of care and quality of life .
BACKGROUND	Studies thus far have shown that these interventions may improve patients ' and caregivers ' outcomes , but the quality of included randomized controlled trials ( RCTs ) is poor and it is difficult to draw firm conclusions as to the effectiveness of such interventions on patients and primary caregivers ' outcomes , hence the current study .
METHODS	A randomized controlled trial in four outpatient mental health clinics in Jordan comparing psycho-educational interventions in the form of six booklets every fortnight , with treatment as usual in people diagnosed with schizophrenia and their primary caregivers .
METHODS	The primary outcome for participants is knowledge of Schizophrenia ; secondary outcomes for patients are positive and negative symptoms of schizophrenia and relapse rate , while secondary outcomes for primary caregivers are burden of care and quality of life .
METHODS	All measures are assessed at baseline , immediately post-intervention and at three months follow-up .
CONCLUSIONS	This randomized control trial , conducted in Jordan among people living with schizophrenia and their primary caregivers , will assess the effect of psycho-educational interventions on knowledge of Schizophrenia , patients ' positive and negative symptoms and quality of life , and caregivers ' burden of care .
BACKGROUND	Current Controlled Trials ISRCTN78084871 .

###25552609
BACKGROUND	Exercise has been shown to improve clinical measures of strength , balance and mobility , and in some cases , has improved symptoms of tremor and rigidity in people with Parkinson 's disease ( PD ) .
BACKGROUND	However , to date , no research has examined whether improvements in trunk control can remedy deficits in dynamic postural stability in this population .
BACKGROUND	The proposed randomised controlled trial aims to establish whether a 12-week exercise programme aimed at improving dynamic postural stability in people with PD ; ( 1 ) is more effective than education ; ( 2 ) is more effective when training frequency is increased ; and ( 3 ) provides greater long-term benefits than education .
METHODS	Forty-five community-dwelling individuals diagnosed with idiopathic PD with a falls history will be recruited .
METHODS	Participants will complete baseline assessments including tests of cognition , vision , disease severity , fear of falling , mobility and quality of life .
METHODS	Additionally , participants will complete a series of standing balance tasks to evaluate static postural stability , while dynamic postural control will be measured during walking using head and trunk-mounted three-dimensional accelerometers .
METHODS	Following baseline testing , participants will be randomly-assigned to one of three intervention groups , who will receive either exercise once per week , exercise 3 days/week , or education .
METHODS	Participants will repeat the same battery of tests conducted at baseline after the 12-week intervention and again following a further 12-week sustainability period .
CONCLUSIONS	This study has the potential to show that low-intensity and progressive trunk exercises can provide a non-invasive and effective means for maintaining or improving postural stability for people with PD .
CONCLUSIONS	Importantly , if the programme is noted to be effective , it could be easily performed by patients within their home environment or under the guidance of available allied health professionals .
BACKGROUND	The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry ( ACTRN12613001175763 ) .

###24975713
OBJECTIVE	To compare the results of transperitoneal laparoscopic vs retroperitoneoscopic simple nephrectomy for benign renal diseases in a prospective randomized design .
METHODS	In this study between January 2009 and August 2013 , 31 patients underwent transperitoneal laparoscopic nephrectomy and 31 retroperitoneoscopic nephrectomy after randomization .
METHODS	The 2 groups were compared for the visual pain score on the first and second postoperative days as the primary end point of the study .
METHODS	Complications were recorded and graded using Dindo-modified Clavien classification of surgical complications .
METHODS	Secondary objectives were to compare each of the operative techniques in terms of duration of surgery , complication rates , and postoperative convalescence .
METHODS	Statistical analysis was performed with SPSS version 16.0 with P < .05 considered statistically significant .
RESULTS	The difference in the visual pain score ( 4.9 vs 2.7 on day 1 ; 3.2 vs 1.1 on day 2 ) and the tramadol requirements ( 167.3 vs 132.8 mg ) were statistically significant and more in the transperitoneal laparoscopic nephrectomy .
RESULTS	The hospital stay and convalescence were significantly lower in retroperitoneoscopic group .
RESULTS	Three patients in transperitoneal laparoscopic nephrectomy group and 2 patients in retroperitoneoscopic group required conversion .
RESULTS	Mean time to normal activities wassignificantly less in retroperitoneal laparoscopic nephrectomy group ( 16.73.5 vs 9.344.9 days ; P = .0001 ) .
CONCLUSIONS	Although both transperitoneal laparoscopic and retroperitoneoscopic simple nephrectomy are feasible options for nonfunctioning kidneys due to benign renal diseases in adults , retroperitoneal laparoscopic nephrectomy is associated with significantly less pain , less analgesic requirement , shorter hospital stay , and short convalescence as compared with transperitoneal laparoscopic approach .

###25358424
BACKGROUND	Breathlessness is common in advanced cancer .
BACKGROUND	The Breathlessness Intervention Service ( BIS ) is a multi-disciplinary complex intervention theoretically underpinned by a palliative care approach , utilising evidence-based non-pharmacological and pharmacological interventions to support patients with advanced disease .
BACKGROUND	We sought to establish whether BIS was more effective , and cost-effective , for patients with advanced cancer and their carers than standard care .
METHODS	A single-centre Phase III fast-track single-blind mixed-method randomised controlled trial ( RCT ) of BIS versus standard care was conducted .
METHODS	Participants were randomised to one of two groups ( randomly permuted blocks ) .
METHODS	A total of 67 patients referred to BIS were randomised ( intervention arm n = 35 ; control arm n = 32 received BIS after a two-week wait ) ; 54 completed to the key outcome measurement .
METHODS	The primary outcome measure was a 0 to 10 numerical rating scale for patient distress due to breathlessness at two-weeks .
METHODS	Secondary outcomes were evaluated using the Chronic Respiratory Questionnaire , Hospital Anxiety and Depression Scale , Client Services Receipt Inventory , EQ-5D and topic-guided interviews .
RESULTS	BIS reduced patient distress due to breathlessness ( primary outcome : -1.29 ; 95 % CI -2.57 to -0.005 ; P = 0.049 ) significantly more than the control group ; 94 % of respondents reported a positive impact ( 51/53 ) .
RESULTS	BIS reduced fear and worry , and increased confidence in managing breathlessness .
RESULTS	Patients and carers consistently identified specific and repeatable aspects of the BIS model and interventions that helped .
RESULTS	How interventions were delivered was important .
RESULTS	BIS legitimised breathlessness and increased knowledge whilst making patients and carers feel ` not alone ' .
RESULTS	BIS had a 66 % likelihood of better outcomes in terms of reduced distress due to breathlessness at lower health/social care costs than standard care ( 81 % with informal care costs included ) .
CONCLUSIONS	BIS appears to be more effective and cost-effective in advanced cancer than standard care .
BACKGROUND	RCT registration at ClinicalTrials.gov NCT00678405 ( May 2008 ) and Current Controlled Trials ISRCTN04119516 ( December 2008 ) .

###25325609
OBJECTIVE	To evaluate the efficacy and tolerability of armodafinil in patients with excessive sleepiness following mild or moderate closed traumatic brain injury ( TBI ) .
METHODS	Randomized , placebo-controlled , double-blind trial followed by open-label extension .
METHODS	40 US centers .
METHODS	Adults with closed TBI ( N = 117 ) , Glasgow Coma Scale score > 8 at time of injury ; baseline Epworth Sleepiness Scale ( ESS ) 10 ; sleep latency < 8 minutes on multiple sleep latency test ( MSLT ) ; and Clinical Global Impression-Severity of Illness ( CGI-S ) score 4 for excessive sleepiness .
METHODS	Patients received armodafinil ( 50 , 150 , or 250 mg/day ) or placebo for 12 weeks followed by an optional 12-month open-label extension .
RESULTS	Outcomes included MSLT , ESS , Clinical Global Impression-Change ( CGI-C ) , TBI-Work Instability Scale ( TBI-WIS ) , CGI-S , and tolerability .
RESULTS	The study was terminated early due to low enrollment .
RESULTS	Patients receiving 250 mg armodafinil showed significant improvement in sleep latency from baseline to final visit versus placebo ( +7.2 minutes vs. +2.4 minutes ; p = 0.0010 ) .
RESULTS	CGI-C ratings were much / very much improved in approximately 50 % of patients receiving 150 and 250 mg armodafinil , compared to 38 % on placebo .
RESULTS	ESS and TBI-WIS scores were not significantly different between groups .
RESULTS	In the open-label extension ( N = 49 ) , patients demonstrated gradual improvement in ESS , TBI-WIS , and CGI-S scores up to 48 weeks post-baseline .
RESULTS	Armodafinil was generally well tolerated , with headache the most common adverse event in both double-blind and open-label portions .
CONCLUSIONS	Armodafinil 250 mg significantly improved sleep latency in patients with excessive sleepiness associated with mild or moderate TBI .
CONCLUSIONS	Efficacy and tolerability of armodafinil were sustained throughout the open-label extension .
BACKGROUND	NCT00893789 , NCT00983437 .

###24547757
BACKGROUND	Is it possible to reach performance equality between boys and girls in a science class ?
BACKGROUND	Given the stereotypes targeting their groups in scientific domains , diagnostic contexts generally lower girls ' performance and non-diagnostic contexts may harm boys ' performance .
OBJECTIVE	The present study tested the effectiveness of a mastery-oriented assessment , allowing both boys and girls to perform at an optimal level in a science class .
METHODS	Participants were 120 boys and 72 girls ( all high-school students ) .
METHODS	Participants attended a science lesson while expecting a performance-oriented assessment ( i.e. , an assessment designed to compare and select students ) , a mastery-oriented assessment ( i.e. , an assessment designed to help students in their learning ) , or no assessment of this lesson .
RESULTS	In the mastery-oriented assessment condition , both boys and girls performed at a similarly high level , whereas the performance-oriented assessment condition reduced girls ' performance and the no-assessment condition reduced boys ' performance .
CONCLUSIONS	One way to increase girls ' performance on a science test without harming boys ' performance is to present assessment as a tool for improving mastery rather than as a tool for comparing performances .

###25460339
BACKGROUND	Traumatic brain injury ( TBI ) is a major public health problem recently , however , no intervention showing convincing efficacy .
BACKGROUND	Therapeutic hypothermia with a relatively long duration ( more than 48 h ) , as a promising treatment measure , might improve the patient outcome following severe TBI .
METHODS	The LTH-1 trial is a prospective , nationwide multicenter , randomized , controlled clinical trial to examine the efficacy and safety of long-term mild hypothermia in adult patients after severe traumatic brain injury .
METHODS	A total of 300 consecutive patients will be recruited from 15 large neurosurgical centers in China .
METHODS	The eligible patient will be randomized to receive either long-term mild hypothermia ( 34-35 C ) for 5 days , or normothermia ( 36-37 C ) .
METHODS	Additionally , a standardized management protocol will be used in all patients .
METHODS	The primary end point is the neurological outcome 6 months post-injury on the Glasgow Outcome Scale .
METHODS	The secondary outcomes include GOS score at one month post-injury , mortality during six months after injury , length of ICU and hospital stay , intracranial pressure control and Glasgow Coma Scale score during the hospital stay and frequency of complications during the six-month follow-up period .
CONCLUSIONS	Long-term hypothermia is recommended by most recent studies and its efficacy urgently needs to be established in randomized controlled settings .
CONCLUSIONS	The LTH-1 trial , together with other ongoing studies , will present more evidence for optimal use of hypothermia in severe TBI patients .

###24682966
OBJECTIVE	RESTORE was a randomized , partially placebo-controlled exploratory study evaluating multiple sclerosis ( MS ) disease activity during a 24-week interruption of natalizumab .
METHODS	Eligible patients were relapse-free through the prior year on natalizumab and had no gadolinium-enhancing lesions on screening brain MRI .
METHODS	Patients were randomized 1:1:2 to continue natalizumab , to switch to placebo , or to receive alternative immunomodulatory therapy ( other therapies : IM interferon -1 a [ IM IFN -- 1a ] , glatiramer acetate [ GA ] , or methylprednisolone [ MP ] ) .
METHODS	During the 24-week randomized treatment period , patients underwent clinical and MRI assessments every 4 weeks .
RESULTS	Patients ( n = 175 ) were randomized to natalizumab ( n = 45 ) , placebo ( n = 42 ) , or other therapies ( n = 88 : IM IFN -- 1a , n = 17 ; GA , n = 17 ; MP , n = 54 ) .
RESULTS	Of 167 patients evaluable for efficacy , 49 ( 29 % ) had MRI disease activity recurrence : 0/45 ( 0 % ) natalizumab , 19/41 ( 46 % ) placebo , 1/14 ( 7 % ) IM IFN -- 1a , 8/15 ( 53 % ) GA , and 21/52 ( 40 % ) MP .
RESULTS	Relapse occurred in 4 % of natalizumab patients and in 15 % -29 % of patients in the other treatment arms .
RESULTS	MRI disease activity recurred starting at 12 weeks ( n = 3 at week 12 ) while relapses were reported as early as 4-8 weeks ( n = 2 in weeks 4-8 ) after the last natalizumab dose .
RESULTS	Overall , 50/167 patients ( 30 % ) , all in placebo or other-therapies groups , restarted natalizumab early because of disease activity .
CONCLUSIONS	MRI and clinical disease activity recurred in some patients during natalizumab interruption , despite use of other therapies .
METHODS	This study provides Class II evidence that for patients with MS taking natalizumab who are relapse-free for 1 year , stopping natalizumab increases the risk of MS relapse or MRI disease activity as compared with continuing natalizumab .

###25973563
BACKGROUND	The efficacy of botulinum neurotoxin type A after prolonged storage at room temperature is currently unknown .
BACKGROUND	This randomized , double-blinded , split-face study investigated the impact of postreconstitution 25C storage for 1 week on the clinical efficacy of incobotulinumtoxinA in the treatment of lateral canthus lines .
METHODS	Twenty-one participants with at least mild to moderate crow 's feet at maximum contraction on the Crow 's Feet Grading Scale ( CFGS ) underwent injection to each lateral canthus area with 10 U of freshly reconstituted and room temperature-stored product and followed for 4 months .
METHODS	Responders were defined as those demonstrating at least a 1-point improvement on their CFGS score .
RESULTS	At each visit ( 2 weeks and 1 , 2 , 3 , and 4 months ) , there was no statistical difference in the rate of responders between the fresh and the stored products .
RESULTS	In addition , the percentage of responders displaying a 2-point versus a 1-point improvement and response longevity did not statistically differ between both products for the entire 4-month study duration .
CONCLUSIONS	Prolonged storage of incobotulinumtoxinA at room temperature does not appear to significantly alter its efficacy or longevity in the treatment of dynamic lateral canthus lines .

###24510656
OBJECTIVE	The aim of this study was to evaluate the safety and tolerability of sitagliptin 100 mg/day in elderly patients with type 2 diabetes .
METHODS	A post hoc pooled analysis of 25 randomized , double-blind , parallel group clinical studies with results available as of 1 December 2011 .
METHODS	Multicenter , international clinical trials .
METHODS	Patients with type 2 diabetes aged 65 years or older .
METHODS	Patients were randomized to sitagliptin 100 mg/day ( n = 1,261 ) or a comparator ( n = 1,185 ) for 12 weeks to 2 years .
METHODS	In each study , investigators reported serious and non-serious adverse events that occurred during the study , and serious adverse events occurring within 14 days following the last dose of study drug .
METHODS	This analysis used patient-level data from each study to assess the exposure-adjusted incidence rates of specific adverse events that occurred following initiation of study drug .
RESULTS	Summary measures of adverse events overall were similar between the sitagliptin and non-exposed ( active comparator or placebo ) groups , except for higher incidences of deaths and drug-related adverse events in the non-exposed group .
RESULTS	Incidence rates of specific adverse events were generally similar between the two groups , with the exception of hypoglycemia .
RESULTS	A lower incidence rate of hypoglycemia was observed in the sitagliptin group compared with the non-exposed group [ 7.0 vs. 14.3 per 100 patient-years ; difference -7.6 ( 95 % CI -11.2 to -4.3 ] ) , primarily due to greater use of sulfonylureas in the non-exposed group .
CONCLUSIONS	In this pooled safety analysis of elderly patients with type 2 diabetes , treatment with sitagliptin 100 mg/day was generally well tolerated for up to 2 years .

###24346096
BACKGROUND	nab-Paclitaxel ( nab-P ) is approved , in the United States , in combination with carboplatin for the first-line treatment of advanced non-small-cell lung cancer , based on a randomized phase 3 trial of nab-P plus carboplatin ( nab-P/C ) versus solvent-based paclitaxel plus carboplatin ( sb-P/C ) .
BACKGROUND	This trial revealed a higher overall response rate ( 33 % versus 25 % ; p = 0.005 ) and longer , but not statistically significant , overall and progression-free survival for nab-P/C versus sb-P/C .
BACKGROUND	In addition , nab-P/C demonstrated lower rates of grade 3 or higher peripheral neuropathy , myalgia , arthralgia , and neutropenia but higher rates of anemia and thrombocytopenia .
BACKGROUND	This report analyzes patient and physician assessment of symptoms within this trial .
METHODS	Patients completed the taxane subscale of the Functional Assessment of Cancer Therapy questionnaire , which focuses on taxane toxicity , including peripheral neuropathy and neurotoxicity .
METHODS	Mean baseline scores and changes from baseline are reported .
METHODS	Physicians also graded the severity of neuropathy at each patient visit using National Cancer Institute Common Toxicity Criteria .
RESULTS	Patients receiving nab-P/C reported significantly less worsening of peripheral neuropathy ( p < 0.001 ) , pain ( p < 0.001 ) , and hearing loss ( p = 0.002 ) .
RESULTS	Patient-reported edema was similar between the two treatment arms .
RESULTS	In agreement with patient-reported symptoms , the results of a per-treatment cycle physician assessment of peripheral neuropathy also favored nab-P/C over sb-P/C ( p < 0.001 ) .
CONCLUSIONS	In this trial of patients receiving first-line treatment for advanced non-small-cell lung cancer , nab-P/C was associated with statistically and clinically significant reductions in patient-reported neuropathy , neuropathic pain in the hands and feet , and hearing loss compared with sb-P/C .

###25248764
BACKGROUND	Inhaled long-acting beta2 agonists used alone and in combination with an inhaled corticosteroid reduce the risk of exacerbations in patients with stable COPD .
BACKGROUND	However , the relative efficacy of these agents in preventing recurrent exacerbations in those recovering from an initial episode is not known .
BACKGROUND	This study compared the rate of COPD exacerbations over the 26 weeks after an initial exacerbation in patients receiving the combination of fluticasone propionate and salmeterol ( FP/SAL ) or SAL alone .
METHODS	Patients ( n = 639 ) aged 40 years were randomized to either twice-daily inhaled FP/SAL 250/50 g or SAL 50 g. Primary , and secondary , endpoints were rates of recurrent severe , and moderate/severe , exacerbations of COPD .
METHODS	Lung function , health outcomes and levels of biomarkers of systemic inflammation were also assessed .
RESULTS	There was no statistically significant treatment difference in rates of recurrent severe exacerbations ( treatment ratio 0.92 [ 95 % CI : 0.58 , 1.45 ] ) and moderate/severe exacerbations ( 0.82 [ 0.64 , 1.06 ] ) between FP/SAL and SAL in the intent-to-treat population .
RESULTS	Pre-dose morning FEV1 change from baseline was greater ( 0.10 L [ 0.04 , 0.16 ] ) with FP/SAL than SAL .
RESULTS	No treatment difference was seen for other endpoints including patient-reported health outcomes and biomarker levels for the full cohort .
CONCLUSIONS	No significant treatment difference between FP/SAL and SAL was seen in COPD exacerbation recurrence for the complete cohort .
CONCLUSIONS	Treatment benefit with FP/SAL over SAL ( treatment ratio 0.68 [ 0.47 , 0.97 ] ) was seen in patients having FEV130 % and prior exposure to ICS .
CONCLUSIONS	No unexpected safety issues were identified with either treatment .
CONCLUSIONS	Patients with the most severe COPD may be more refractory to treatment .
BACKGROUND	ClinicalTrials.gov ( identifier NCT01110200 ) .
BACKGROUND	This study was funded by GlaxoSmithKline ( study number ADC113874 ) .

###25335327
OBJECTIVE	To evaluate the efficacy of internal application of Qigui Mixture ( QM ) and external application of Qigui Huoxue Lotion ( QHL ) in treating type 2 diabetic peripheral neuropathy ( DNP ) patients of qi-yin deficiency complicated phlegm-dampness blocking collaterals syndrome ( QYD-PDBCS ) , and to primarily discuss its mechanism .
METHODS	Totally 62 DPN patients of QYD-PDBCS were randomly assigned to the treatment group ( 31 cases ) and the control group ( 31 cases ) .
METHODS	All patients received routine comprehensive therapy .
METHODS	Patients in the control group took Mecobalamine Tablet , 500 microg each time , 3 times per day .
METHODS	Patients in the treatment group additionally took QM , 200 mL per day , twice daily .
METHODS	Besides , they had foot bath in QHL 10 - 15 min every evening for 3 months .
METHODS	The efficacy was assessed by Chinese medical symptom integrals and Toronto clinical scoring system ( TCSS ) before treatment , 2 and 3 months after treatment .
METHODS	The nerve conduction velocity was determined ; the serum levels of total antioxidant capacity ( T - AOC ) , malondialdehyde ( MDA ) , and superoxide dismutase ( SOD ) were detected 2 and 3 months after treatment .
RESULTS	The total effective rates of Chinese medical symptom integrals and TCSS score were obviously higher in the treatment group than in the control group ( P < 0.05 ) .
RESULTS	The nerve conduction velocity was significantly improved in the treatment group , when compared with before treatment ( P < 0.01 ) .
RESULTS	There was statistical difference in the nerve conduction velocity difference of right median nerve motor branch , bilateral tibial nerve motor branches , bilateral common peroneal nerve motor branches , bilateral ulnar nerve sensory branches , and left tibial nerve sensory branch ( P < 0.05 ) .
RESULTS	Compared with before treatment , serum levels of T-AOC and SOD significantly increased , and the level of MDA decreased significantly in the treatment group after 2 and 3 months of treatment ( P < 0.01 ) .
RESULTS	But only the SOD level increased significantly in the control group ( P < 0.01 ) .
RESULTS	There was no statistical difference in increased T-AOC level between the two groups after 2 months of treatment ( P > 0.05 ) , but there was statistical difference in increased SOD level and decreased MDA level ( P < 0.05 ) .
RESULTS	There was statistical difference in increased T-AOC and SOD levels and decreased MDA level between the two groups after 3 months of treatment ( P < 0.05 ) .
RESULTS	No adverse reaction occurred during the therapeutic course .
CONCLUSIONS	The internal application of QM and external application of QHL combined with Mecobalamine in treating DPN was safe and effective , with more significant efficacy than using Mecobalamine alone .
CONCLUSIONS	Its mechanism might be associated with resistance to oxidative stress .

###25656074
OBJECTIVE	To compare the effectiveness and costs of telephone-only approach to in-person plus telephone for delivering an evidence-based , coordinated care management program for dementia .
METHODS	We randomized 151 patient-caregiver dyads from an underserved predominantly Latino community to two arms that shared a care management protocol but implemented in different formats : in-person visits at home and/or in the community plus telephone and mail , versus telephone and mail only .
METHODS	We compared between-arm caregiver burden and care-recipient problem behaviors ( primary outcomes ) and patient-caregiver dyad retention , care quality , health care utilization , and costs ( secondary outcomes ) at 6 - and 12-months follow-up .
RESULTS	Care quality improved substantially over time in both arms .
RESULTS	Caregiver burden , care-recipient problem behaviors , retention , and health care utilization did not differ across arms but the in-person program cost more to deliver .
CONCLUSIONS	Dementia care quality improved regardless of how care management was delivered ; large differences in effectiveness or cost offsets were not detected .

###25106783
BACKGROUND	Elevated circulating levels of the protein galectin-3 , a mediator of fibrogenesis , have previously been associated with adverse outcomes in heart failure ( HF ) patients and appear to modify response to certain pharmacologic therapies .
BACKGROUND	This study investigated the relationship between galectin-3 level and clinical outcomes in HF patients randomized to implantable cardioverter defibrillator ( ICD-only ) or cardiac resynchronization therapy ( CRT-D ) .
RESULTS	Plasma galectin-3 concentrations were measured in 654 New York Heart Association functional class I/II patients participating in the MADIT-CRT trial .
RESULTS	A heterogeneity of response was detected between pre-implantation galectin-3 and randomization group ( CRT-D or ICD-only ) on the primary MADIT-CRT trial end point of nonfatal HF event or death ( P = .045 ) .
RESULTS	Among patients with baseline galectin-3 levels in the top quartile of the distribution , CRT-D was associated with a 65 % reduction in risk of the primary end point ( hazard ratio [ HR ] 0.35 , 95 % confidence interval [ CI ] 0.19-0 .67 ) , whereas among patients with lower baseline galectin-3 values CRT-D was associated with a 25 % decrease in risk ( HR 0.75 , 95 % CI .
RESULTS	0.51-1 .11 ) .
RESULTS	Baseline galectin-3 level also was observed to be an independent predictor of the primary end point ( multivariable adjusted HR per log unit increase : 1.55 ; 95 % CI 1.01-2 .38 ; P = .043 ) .
CONCLUSIONS	Elevated galectin-3 was found to be an independent predictor of adverse HF outcome in patients with mildly symptomatic HF .
CONCLUSIONS	A significant interaction of device randomization group with pre-implantation galectin-3 level was detected , with HF patients with the highest baseline galectin-3 levels deriving a disproportionately larger benefit from CRT-D .

###24268977
BACKGROUND	Although mitral regurgitation ( MR ) results in left ventricular ( LV ) volume overload , right ventricular ( RV ) function may also be impaired .
BACKGROUND	We investigated the influence of short-term beta-blockade on RV function in patients with moderate-severe MR.
METHODS	Twenty-six patients were randomised in a cross-over design to receive two weeks of beta-blockade or placebo .
METHODS	Echocardiography was performed at baseline and at the end of the treatment periods .
METHODS	Measurements included : RV ejection fraction ( RVEF ) tricuspid annular motion and Tei index .
RESULTS	No differences in mean RVEF ( 64.0 6.0 v 67.0 8.0 % , p = 0.3 ) , tricuspid annular motion ( 13.5 3.0 v 14.7 2.9 cm/s , p = 0.5 ) , or median Tei index ( 0.61 ( 0.54 , 0.88 ) v 0.59 ( 0.54 , 0.74 ) , p = 0.8 ) were observed between placebo and metoprolol , despite significantly longer cardiac time intervals .
RESULTS	Tei index under both conditions was significantly reduced .
CONCLUSIONS	Short-term treatment with a beta-blocker did not influence RV function in these patients .
CONCLUSIONS	Interestingly , the RV Tei index was high suggesting significant RV dysfunction despite normal RVEF .

###25448672
BACKGROUND	A parallel-group randomized controlled trial ( RCT ) was conducted to evaluate the effect of combining the interscalene brachial plexus block ( IBPB ) with Intravenous-inhalation combined anesthesia to isolated Intravenous-inhalation anesthesia in the upper extremity fractures surgery of elderly patients .
METHODS	One hundred elderly patients who underwent upper extremity surgery were randomly assigned to received isolated Intravenous-inhalation combined anesthesia ( group CI , n = 50 ) and IBPB associated with Intravenous-inhalation combined anesthesia ( group NB , n = 50 ) .
METHODS	Associated side effects , recovery time after operation , as well as the dose of intraoperative vasoactive agents and auxiliary drugs were noted .
RESULTS	The two groups were not significantly different in gender ( P = 0.539 ) , ages ( P = 0.683 ) and weight ( P = 0.212 ) .
RESULTS	Five patients ( 10 % ) in the group NB and 17 patients ( 34 % ) in the group CI suffered from preoperative hypotension ( P = 0.004 ) .
RESULTS	Besides , lower incidence of other adverse effects such as mental stress , incision pain and hypertension were also found in the group NB ; however , the differences were not statistically significant ( P > 0.05 ) .
RESULTS	The consumption of general anesthetics in the group NB was significantly less than that of the group CI ( propofol , P = 0.004 ; lsoflurane , P < 0.001 ) , and the recovery time of the group NB was significantly shorter than that of the group CI ( P = 0.020 ) .
CONCLUSIONS	Combining IBPB with Intravenous-inhalation combined anesthesia in elderly patients hold a greater potential for upper extremity fractures surgery due to its improved clinical effectiveness and fewer side effects .

###25539989
BACKGROUND	Chronic heart failure , is increasing due to the aging population and improvements in heart disease detection and management .
BACKGROUND	The prevalence is estimated at ~ 10 % of the French general practice patient population over 59 years old .
BACKGROUND	The primary objective of this study is to improve the quality of life for heart failure patients though a complex intervention involving patient and general practitioner ( GP ) education in primary care .
METHODS	A randomised , cluster controlled trial , stratified over 4 areas of the Auvergne region in France comparing intervention and control groups .
METHODS	The inclusion criteria are : patients older than 50 years with New York Heart Association ( NYHA ) stage I , II , or III heart failure , with reduced ejection fraction or with preserved ejection fraction .
METHODS	Heart failure should be confirmed by the patient 's cardiologist according to the European Society of Cardiology guidelines criteria .
METHODS	The exclusion criteria include : severe cognitive disorders , living in an institution , participating in another clinical trial , having NYHA stage IV heart failure , or a lack of French language skills .
METHODS	The complex intervention consists of training at the GP practice with an interactive 2-day workshop to provide a patient 's education programme .
METHODS	GPs are trained to perform case management , lifestyle counselling and motivational interviewing , to educate patients on the main topics including clinical alarm signs , physical activity , diet and cardiovascular risk factors .
METHODS	The patients ' education sessions are scheduled at 1 , 4 , 7 , 10 , 13 and 19 months following the start of the trial .
METHODS	The primary outcome to be assessed is the impact on the quality of life as determined using two questionnaires : the Minnesota Living with Heart Failure Questionnaire and SF-36 .
METHODS	To detect a difference in the mean quality of life at 19 months , we anticipate studying a minimum of 400 patients from 80 GPs .
CONCLUSIONS	This trial will provide insight into the effectiveness of a complex intervention to educate patients with heart failure including a 2-day GP workshop and patients ' education programme in the setting of a GP consultation to improve the quality of life in patients with chronic heart failure .
CONCLUSIONS	This complex intervention tool could be used during initial and further medical training .
BACKGROUND	ETIC is a cluster-randomised , controlled trial registered on ClinicalTrials.gov [ NCT01065142 , 2010 , Feb 8 ] and the French drug agency [ Agence Nationale de Scurit du Mdicament et des produits de sant ; registration number : 2009-A01142-55 , on March 5th , 2010 ] .

###25370155
BACKGROUND	Enterocolitis ( EC ) is the most common and serious postoperative complication of Hirschsprung 's disease ( HD ) .
BACKGROUND	Probiotics potentially play a protective role in maintaining intestinal mucosal integrity .
BACKGROUND	Based on the beneficial effects of probiotics , we hypothesized that oral probiotics could decrease the incidence and severity of Hirschsprung 's disease-associated enterocolitis ( HAEC ) .
METHODS	We conducted a prospective , multicenter , randomized , and controlled trial to assess whether oral probiotics could decrease the incidence and severity of HAEC .
METHODS	HD patients were randomly assigned into the control group and probiotic-treated group .
METHODS	All children in probiotic-treated group were fed with probiotics per day for 4weeks .
METHODS	In next 3months , the incidence and severity of HAEC were analyzed .
METHODS	The peripheral blood T lymphocyte subsets and cytokines , including TNF - , IFN - , IL-6 , and IL-10 , were analyzed by flow cytometry and enzyme immunoassay ( EIA ) .
RESULTS	Compared with the control group , the incidence of HAEC in the probiotic-treated group was significantly diminished .
RESULTS	The severity of EC was also remarkably decreased .
RESULTS	Furthermore , probiotics balanced T lymphocyte subsets .
RESULTS	Moreover , pro-inflammatory cytokines TNF - , IFN - , and IL-6 were significantly decreased and anti-inflammatory cytokine IL-10 was notably increased in probiotic-treated group .
CONCLUSIONS	Probiotics not only significantly diminished the incidence but also decreased the severity of HAEC .
CONCLUSIONS	Moreover , our study revealed that probiotics decreased pro-inflammatory cytokine and increased anti-inflammatory cytokine and furthermore balanced T lymphocytes ( registered with ClinicalTrials.gov , NCT number : NCT01934959 ) .

###24323795
BACKGROUND	Renal impairment increases the risk of stroke and bleeding in patients with atrial fibrillation .
BACKGROUND	In the Randomized Evaluation of Long-Term Anticoagulant Therapy ( RELY ) trial , dabigatran , with 80 % renal elimination , displayed superiority over warfarin for prevention of stroke and systemic embolism in the 150-mg dose and significantly less major bleeding in the 110-mg dose in 18 113 patients with nonvalvular atrial fibrillation .
BACKGROUND	This prespecified study investigated these outcomes in relation to renal function .
RESULTS	Glomerular filtration rate was estimated with the Cockcroft-Gault , Chronic Kidney Disease Epidemiology Collaboration ( CKD-EPI ) , and Modification of Diet in Renal Disease ( MDRD ) equations in all randomized patients with available creatinine at baseline ( n = 17 951 ) , and cystatin C-based glomerular filtration rate was estimated in a subpopulation with measurements available ( n = 6190 ) .
RESULTS	A glomerular filtration rate 80 , 50 to < 80 , and < 50 mL/min was estimated in 32.6 % , 47.6 % , and 19.8 % and in 21.6 % , 59.6 % , and 18.8 % of patients based on Cockcroft-Gault and CKD-EPI , respectively .
RESULTS	Rates of stroke or systemic embolism , major bleeding , and all-cause mortality increased as renal function decreased .
RESULTS	The rates of stroke or systemic embolism were lower with dabigatran 150 mg and similar with 110 mg twice daily compared with warfarin , without significant heterogeneity in subgroups defined by renal function ( interaction P > 0.1 for all ) .
RESULTS	For the outcome of major bleeding , there were significant interactions between treatment and renal function according to CKD-EPI and MDRD equations , respectively ( P < 0.05 ) .
RESULTS	The relative reduction in major bleeding with either dabigatran dose compared with warfarin was greater in patients with glomerular filtration rate 80 mL/min .
CONCLUSIONS	The efficacy of both dosages of dabigatran was consistent with the overall trial irrespective of renal function .
CONCLUSIONS	However , with the CKD-EPI and MDRD equations , both dabigatran dosages displayed significantly lower rates of major bleeding in patients with glomerular filtration rate 80 mL/min .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00262600 .

###25964246
OBJECTIVE	To determine the prognostic and predictive value of intrinsic subtyping by using immunohistochemical ( IHC ) biomarkers for ipsilateral breast relapse ( IBR ) in participants in an early breast cancer randomized trial of tamoxifen with or without breast radiotherapy ( RT ) .
METHODS	IHC analysis of estrogen receptor , progesterone receptor , human epidermal growth factor receptor 2 ( HER2 ) , cytokeratin 5/6 , epidermal growth factor receptor , and Ki-67 was conducted on 501 of 769 available blocks .
METHODS	Patients were classified as luminal A ( n = 265 ) , luminal B ( n = 165 ) , or high-risk subtype ( luminal HER2 , n = 22 ; HER2 enriched , n = 13 ; basal like , n = 30 ; or triple-negative nonbasal , n = 6 ) .
METHODS	Median follow-up was 10 years .
RESULTS	Classification by subtype was prognostic for IBR ( 10-year estimates : luminal A , 5.2 % ; luminal B , 10.5 % ; high-risk subtypes , 21.3 % ; P < .001 ) .
RESULTS	Luminal subtypes seemed to derive less benefit from RT ( luminal A hazard ratio [ HR ] , 0.40 ; luminal B HR , 0.51 ) than high-risk subtypes ( HR , 0.13 ) ; however , the overall subtype-treatment interaction term was not significant ( P = .26 ) .
RESULTS	In an exploratory analysis of women with clinical low-risk ( age older than 60 years , T1 , grade 1 or 2 ) luminal A tumors ( n = 151 ) , 10-year IBR was 3.1 % versus 11.8 % for the high-risk cohort ( n = 341 ; P = .0063 ) .
RESULTS	Clinical low-risk luminal A patients had a 10-year IBR of 1.3 % with tamoxifen versus 5.0 % with tamoxifen plus RT ( P = .42 ) .
RESULTS	Multivariable analysis showed that RT ( HR , 0.31 ; P < .001 ) , clinical risk group ( HR , 2.2 ; P = .025 ) , and luminal A subtype ( HR , 0.25 ; P < .001 ) were significantly associated with IBR .
CONCLUSIONS	IHC subtyping was prognostic for IBR but was not predictive of benefit from RT. .
CONCLUSIONS	Further studies may validate the exploratory finding of a low-risk luminal A group who may be spared breast RT. .

###24714097
BACKGROUND	Dry skin reflects a skin barrier defect which can lead to atopic dermatitis .
BACKGROUND	Little is known about the distinct effects of emollient use in children with dry skin and atopic predisposition .
OBJECTIVE	We investigated the effects of daily application of pressed ice plant juice ( PIPJ ) - based emollients and petrolatum-based emollients .
METHODS	Children aged 2-6 years with dry skin and atopic predisposition were randomized into 2 groups : group 1 received emollients containing PIPJ and natural lipids , while group 2 received petrolatum-based emollients .
METHODS	Skin condition and biophysical properties of the skin barrier were assessed at inclusion and weeks 4 , 12 and 16 .
RESULTS	Skin condition improved significantly in all children .
RESULTS	Comparing the groups , children treated with emollients containing PIPJ showed significantly higher stratum corneum hydration values and significantly lower transepidermal water loss values at week 16 on the forearm and forehead .
RESULTS	A significant decrease in skin pH was noted in group 2 on the forearm and forehead ; group 1 showed a stable course .
CONCLUSIONS	Early intervention with emollients in children with dry skin condition and atopic predisposition may improve their skin condition during daily emollient application .
CONCLUSIONS	PIPJ-based formulations may be helpful to maintain skin barrier integrity .

###24884885
BACKGROUND	In 2010 a Cochrane review confirmed that folic acid ( FA ) supplementation prevents the first - and second-time occurrence of neural tube defects ( NTDs ) .
BACKGROUND	At present some evidence from observational studies supports the hypothesis that FA supplementation can reduce the risk of all congenital malformations ( CMs ) or the risk of a specific and selected group of them , namely cardiac defects and oral clefts .
BACKGROUND	Furthermore , the effects on the prevention of prematurity , foetal growth retardation and pre-eclampsia are unclear.Although the most common recommendation is to take 0.4 mg/day , the problem of the most appropriate dose of FA is still open.The aim of this project is to assess the effect a higher dose of peri-conceptional FA supplementation on reducing the occurrence of all CMs .
BACKGROUND	Other aims include the promotion of pre-conceptional counselling , comparing rates of selected CMs , miscarriage , pre-eclampsia , preterm birth , small for gestational age , abruptio placentae .
METHODS	This project is a joint effort by research groups in Italy and the Netherlands .
METHODS	Women of childbearing age , who intend to become pregnant within 12months are eligible for the studies .
METHODS	Women are randomly assigned to receive 4mg of FA ( treatment in study ) or 0.4 mg of FA ( referent treatment ) daily .
METHODS	Information on pregnancy outcomes are derived from women-and-physician information.We foresee to analyze the data considering all the adverse outcomes of pregnancy taken together in a global end point ( e.g. : CMs , miscarriage , pre-eclampsia , preterm birth , small for gestational age ) .
METHODS	A total of about 1,000 pregnancies need to be evaluated to detect an absolute reduction of the frequency of 8 % .
METHODS	Since the sample size needed for studying outcomes separately is large , this project also promotes an international prospective meta-analysis .
CONCLUSIONS	The rationale of these randomized clinical trials ( RCTs ) is the hypothesis that a higher intake of FA is related to a higher risk reduction of NTDs , other CMs and other adverse pregnancy outcomes .
CONCLUSIONS	Our hope is that these trials will act as catalysers , and lead to other large RCTs studying the effects of this supplementation on CMs and other infant and maternal outcomes .
BACKGROUND	Italian trial : ClinicalTrials.gov Identifier : NCT01244347.Dutch trial : Dutch Trial Register ID : NTR3161 .

###25043754
OBJECTIVE	Inflammatory processes , which raise the unsteadiness of brain neuron membrane potentials , might enhance the development of epilepsy .
OBJECTIVE	Inflammation is a substantial indicator of epilepsy risk .
OBJECTIVE	In this study , we evaluated whether chronic osteomyelitis ( COM ) , a chronic inflammatory disease , increases epilepsy risk .
METHODS	A Taiwanese national insurance claims dataset of more than 22 million enrollees was used to select 20,996 COM patients and 83,973 randomly selected age - and gender-matched controls to investigate epilepsy development over an 11-year follow-up period , starting on January 1 , 2000 and ending on December 31 , 2010 .
METHODS	The epilepsy risk was analyzed using a Cox proportional hazards regression model .
RESULTS	Comorbidities known to elevate epilepsy risk , including diabetes , hypertension , head injury , stroke , and cancer , were commonly noted in the COM cohort , which had considerably higher risk of epilepsy than did the control group .
RESULTS	Comparing only those without comorbidities , COM patients still exhibited higher epilepsy risk than the control group did ( adjusted hazard ratio [ aHR ] = 3.87 , 95 % confidence interval [ CI ] : 3.01-4 .98 ) .
RESULTS	The younger population exhibited an even greater risk ( age 39 years : aHR = 6.10 , 95 % CI : 4.00-9 .30 ; age 65 years : aHR = 1.66 , 95 % CI : 1.28-2 .16 ) .
CONCLUSIONS	This is the first study linking COM to an increased risk in epilepsy development .
CONCLUSIONS	The results demonstrated that COM is a significant predictor of epilepsy .
CONCLUSIONS	Further study of COM patients , particularly young patients , is recommended to facilitate epilepsy prevention .

###25155998
BACKGROUND	Hypertension is poorly controlled .
BACKGROUND	Team-based care and changes in the process of care have been proposed to address these quality problems .
BACKGROUND	However , assessing care processes is difficult because they are often confounded even in randomized behavioral studies by unmeasured confounders based on discretion of health care providers .
OBJECTIVE	To evaluate the effects of process measures including number of counseling sessions about lifestyle modification and number of antihypertensive medications on blood pressure change and payer-perspective treatment costs .
METHODS	Data were obtained from two prospective , cluster randomized controlled clinical trials ( Trial A and B ) implementing physician-pharmacist collaborative interventions compared with usual care over six months in community-based medical offices in the Midwest .
METHODS	Multivariate linear regression models with both instrumental variable methods and as-treated methods were utilized .
METHODS	Instruments were indicators for trial and study arms .
METHODS	Models of blood pressure change and costs included both process measures , demographic variables , and clinical variables .
RESULTS	The analysis included 496 subjects .
RESULTS	As-treated methods showed no significant associations between process and outcomes .
RESULTS	The instruments used in the study were insufficient to simultaneously identify distinct process effects .
RESULTS	However , the post-hoc instrumental variable models including one process measure at a time while controlling for the other process demonstrated significant associations between the processes and outcomes with estimates considerably larger than as-treated estimates .
CONCLUSIONS	Instrumental variable methods with combined randomized behavioral studies may be useful to evaluate the effects of different care processes .
CONCLUSIONS	However , substantial distinct process variation across studies is needed to fully capitalize on this approach .
CONCLUSIONS	Instrumental variable methods focusing on individual processes provided larger and stronger outcome relationships than those found using as-treated methods which are subject to confounding .

###25078976
BACKGROUND	The pharmacokinetic properties of the immediate-release ( IR ) and the recently developed controlled-release ( CR ) formulation of pregabalin are dose proportional .
BACKGROUND	Pregabalin IR can be taken with or without food .
OBJECTIVE	This analysis characterizes the effect of food on pregabalin CR .
OBJECTIVE	The objectives of this analysis were : ( 1 ) to evaluate the effect of administration time and fat or caloric content of an accompanying meal on the pharmacokinetic properties of a single dose of pregabalin CR ( 330mg ) relative to a single dose of pregabalin IR ( 300mg ) ; ( 2 ) to evaluate the pharmacokinetic properties of a single dose of pregabalin CR administered fasted relative to a single dose of pregabalin CR administered immediately after food ; and ( 3 ) to determine the safety and tolerability of single-dose administration of pregabalin CR and IR with and without food .
METHODS	The effect of food on the pharmacokinetic properties of pregabalin CR was determined in five phase I , open-label , single-dose , crossover studies ( 24-28 participants/study ) .
METHODS	Caloric and fat content of meals were varied and treatments were administered in the morning , at midday , or in the evening .
METHODS	Blood samples were collected up to 48h post-dose .
METHODS	Pharmacokinetic parameters were estimated from plasma concentration-time data using standard noncompartmental methods .
METHODS	Adverse events were monitored throughout all studies .
RESULTS	One hundred and twenty-eight healthy participants ( 19-54years of age ) received pregabalin .
RESULTS	Peak plasma concentrations ( C max ) were lower for CR than the respective pregabalin IR doses , and time to C max occurred later .
RESULTS	When pregabalin CR was administered with food at midday or in the evening , total exposures [ area under the plasma concentration-time curve from time zero extrapolated to infinite time ( AUC ) ] were equivalent for pregabalin CR and IR formulations regardless of fat or caloric content .
RESULTS	When pregabalin CR was administered with an 800-1 ,000 calorie medium-fat breakfast , AUC was equivalent for pregabalin CR and IR .
RESULTS	Bioequivalence criteria for comparison of pregabalin CR after a low - or medium-calorie breakfast relative to pregabalin IR were not met ; however , bioavailability of the pregabalin CR vs. IR formulation was relatively high ( 75-86 % ) .
RESULTS	When pregabalin CR was administered fasted , the AUC was 70-78 % of the AUC of pregabalin CR administered with food and bioequivalence criteria were not met .
RESULTS	Additionally , the AUC of the pregabalin CR formulation administered fasted was 62-69 % of that of pregabalin IR administered fasted and bioequivalence criteria were not met .
RESULTS	Single-dose pregabalin CR and IR were well tolerated in all studies , with no serious or severe adverse events reported .
CONCLUSIONS	Time of day of administration and the fat and caloric content of the accompanying meal had minimal overall effect on the pharmacokinetic properties and bioavailability of the pregabalin CR formulation .

###25467591
BACKGROUND	There is a high medical need for an interferon-free , all-oral , short-duration therapy for hepatitis C virus ( HCV ) that is highly effective across diverse patient populations , including patients with cirrhosis or previous null response to pegylated interferon ( peginterferon ) plus ribavirin ( PR-null responders ) .
BACKGROUND	We aimed to assess the efficacy , safety , and effective treatment duration of grazoprevir ( an HCV NS3/4A protease inhibitor ) combined with elbasvir ( an HCV NS5A inhibitor ) with or without ribavirin in patients with HCV genotype 1 infection with baseline characteristics of poor response .
METHODS	The C-WORTHY trial is a randomised , open-label phase 2 trial of grazoprevir plus elbasvir with or without ribavirin ; here we report findings for two cohorts of previously untreated patients with cirrhosis ( cohort 1 ) and those with previous PR-null response with or without cirrhosis ( cohort 2 ) enrolled in part B of the study .
METHODS	Eligible patients were adults aged 18 years or older with chronic HCV genotype 1 infection and HCV RNA concentrations of 10000 IU/mL or higher in peripheral blood .
METHODS	We randomly assigned patients to receive grazoprevir ( 100 mg daily ) and elbasvir ( 50 mg daily ) with or without ribavirin for 12 or 18 weeks .
METHODS	Randomisation was done centrally with an interactive voice response system ; patients and study investigators were masked to treatment duration up to week 12 but not to treatment allocation .
METHODS	The primary endpoint was the proportion of patients achieving HCV RNA less than 25 IU/mL at 12 weeks after end of treatment ( SVR12 ) , assessed by COBAS TaqMan version 2.0 .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01717326 .
RESULTS	We describe findings for 253 patients enrolled in cohort 1 ( n = 123 ) or cohort 2 ( n = 130 ) .
RESULTS	In cohort 1 , we randomly assigned 60 patients to the 12-week regimen ( 31 with ribavirin and 29 with no ribavirin ) and 63 to the 18-week regimen ( 32 with ribavirin and 31 with no ribavirin ) ; in cohort 2 , we randomly assigned 65 patients to the 12-week regimen ( 32 with ribavirin and 33 with no ribavirin ) and 65 to the 18-week regimen ( 33 with ribavirin and 32 with no ribavirin .
RESULTS	High SVR12 rates were achieved irrespective of the use of ribavirin or extension of the treatment duration from 12 to 18 weeks ; SVR12 rates ranged from 90 % ( 95 % CI 74-98 ; 28/31 ; cohort 1 , 12 weeks , ribavirin-containing ) to 100 % ( 95 % CI 89-100 ; 33/33 ; cohort 2 , 18 weeks , ribavirin-containing ) .
RESULTS	Among patients treated for 12 weeks with grazoprevir plus elbasvir without ribavirin , 97 % ( 95 % CI 82-100 , 28/29 ) of patients in cohort 1 and 91 % ( 76-98 , 30/33 ) of patients in cohort 2 achieved SVR12 .
RESULTS	Adverse events reported in more than 10 % of patients were fatigue ( 66 patients , 26 % [ 95 % CI 21-32 ] ) , headache ( 58 patients , 23 % [ 95 % CI 18-29 ] ) , and asthenia ( 35 patients , 14 % [ 95 % CI 10-19 ] ) .
CONCLUSIONS	Treatment with grazoprevir plus elbasvir , both with and without ribavirin and for both 12 and 18 weeks ' treatment duration , showed high rates of efficacy in previously untreated patients with cirrhosis and previous PR-null responders with and without cirrhosis .
CONCLUSIONS	These results support the phase 3 development of grazoprevir plus elbasvir .
BACKGROUND	Merck & Co , Inc. .

###24680372
BACKGROUND	Suvorexant ( MK-4305 ) is an orexin receptor antagonist shown to be efficacious for insomnia over 3 months .
BACKGROUND	We aimed to assess its clinical profile during and after 1 year of treatment .
METHODS	We did a randomised , placebo-controlled , parallel-group trial at 106 investigational centres in the Americas , Australia , Europe , and South Africa from December , 2009 , to August , 2011 .
METHODS	Patients aged 18 years or older with primary insomnia by DSM-IV-TR criteria were assigned using a computer-generated randomised allocation schedule to receive nightly suvorexant ( 40 mg for patients younger than 65 years , 30 mg for patients aged 65 years or older ) or placebo at a 2:1 ratio for 1 year with a subsequent 2-month randomised discontinuation phase in which patients on suvorexant either continued suvorexant or were abruptly switched to placebo while patients on placebo remained on placebo .
METHODS	Treatment assignment was masked from patients and investigators .
METHODS	The primary objective was to assess the safety and tolerability of suvorexant for up to 1 year .
METHODS	Secondary objectives were to assess the efficacy of suvorexant for improving patient-reported subjective total sleep time ( sTST ) and time to sleep onset ( sTSO ) over the first month of treatment .
METHODS	Efficacy endpoints over the first month were assessed with a mixed model with terms for baseline value of the response variable , age , sex , region , treatment , time , and treatment by time interaction .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01021813 .
RESULTS	322 ( 62 % ) of 522 patients randomly assigned to receive suvorexant and 162 ( 63 % ) of 259 assigned to receive placebo completed the 1-year phase .
RESULTS	Over 1 year , 362 ( 69 % ) of 521 patients treated with suvorexant experienced any adverse events compared with 164 ( 64 % ) of 258 treated with placebo .
RESULTS	Serious adverse events were recorded in 27 patients ( 5 % ) who received suvorexant and 17 ( 7 % ) who received placebo .
RESULTS	The most common adverse event , somnolence , was reported for 69 patients ( 13 % ) who received suvorexant and seven ( 3 % ) who received placebo .
RESULTS	At month 1 , suvorexant ( 517 patients in the efficacy population ) showed greater efficacy than placebo ( 254 in the efficacy population ) in improving sTST ( 387 min vs 160 min ; difference 227 , 95 % CI 164 to 290 ; p < 00001 ) and sTSO ( -180 min vs -84 min , difference -95 , -146 to -45 ; p = 00002 ) .
CONCLUSIONS	Our findings show that suvorexant was generally safe and well tolerated over 1 year of nightly treatment in patients with insomnia , with efficacy noted for subjective measures of sleep onset and maintenance .
BACKGROUND	Merck & Co Inc. .

###25377520
BACKGROUND	Denmark has inferior cancer survival rates compared with many European countries .
BACKGROUND	The main reason for this is suggested to be late diagnosis at advanced cancer stages .
BACKGROUND	Cancer diagnostic work-up begins in general practice in 85 % of all cancer cases .
BACKGROUND	Thus , general practitioners ( GPs ) play a key role in the diagnostic process .
BACKGROUND	The latest Danish Cancer Plan included continuing medical education ( CME ) on early cancer diagnosis in general practice to improve early diagnosis .
BACKGROUND	This dual aims of this protocol are , first , to describe the conceptualisation , operationalisation and implementation of the CME and , second , to describe the study design and outcomes chosen to evaluate the effects of the CME .
METHODS	The intervention is a CME in early cancer diagnosis targeting individual GPs .
METHODS	It was developed by a step-wise approach .
METHODS	Barriers for early cancer diagnosis at GP level were identified systematically and analysed using the behaviour system involving capability , opportunity and motivation described by Michie et al. .
METHODS	The study will be designed as a geographical cluster randomised stepped wedge study .
METHODS	The study population counts 836 GPs from 417 general practices in the Central Denmark Region , geographically divided into eight clusters .
METHODS	GPs from each cluster will be invited to a CME meeting at a certain date three weeks apart .
METHODS	The primary outcomes will be primary care interval and GP referral rate on cancer suspicion .
METHODS	Data will be obtained from national registries , GP-completed forms on patients referred to cancer fast-track pathways and GP-completed online questionnaires before and after the intervention .
CONCLUSIONS	To our knowledge , this will be the first study to measure the effect of a theory-based CME in early cancer diagnosis at three levels : GP knowledge and attitude , GP activity and patient outcomes .
CONCLUSIONS	The achieved knowledge will contribute to the understanding of whether and how general practice 's ability to perform cancer diagnosis may be improved .
BACKGROUND	Registered as NCT02069470 on ClinicalTrials.gov .

###24809261
OBJECTIVE	To observe the clinical effects of early use of neuromuscular blocking agents ( NMBA ) in patients with severe sepsis and acute respiratory distress syndrome ( ARDS ) .
METHODS	A prospective study was conducted .
METHODS	96 patients with severe sepsis and ARDS admitted from July 2012 to September 2013 to intensive care unit ( ICU ) of Liuzhou People 's Hospital in Guangxi Zhuang Autonomous Region were enrolled and divided into severe ARDS group ( n = 48 ) and moderate ARDS group ( n = 48 ) according to the Berlin definition of ARDS .
METHODS	Then patients in each group were randomly divided into treatment group ( n = 24 ) and control group ( n = 24 ) .
METHODS	All patients with diagnosis in accordance with the 2008 international septic shock and severe sepsis treatment guidelines were provided with comprehensive treatment and mechanical ventilation on the basis of analgesia and sedation .
METHODS	The patients in treatment group were given a loading dose of vecuronium during mechanical ventilation , started with 0.1 mg/kg up to 0.05 mgkg ( -1 ) h ( -1 ) for continuous intravenous infusion for 24-48 hours .
METHODS	The acute physiology and chronic health evaluation II ( APACHEII ) score , sequential organ failure assessment ( SOFA ) , arterial oxygenation index ( PaO2/FiO2 ) , central venous oxygen saturation ( ScvO2 ) , arterial blood lactate ( Lac ) , C-reactive protein ( CRP ) levels of two groups were compared before treatment and 48 hours after treatment , and 21-day mortality rate was finally compared .
RESULTS	In moderate or severe ARDS group , there were no statistically significant difference in APACHEII score , SOFA score , PaO2/FiO2 , ScvO2 , Lac and CRP before treatment between two groups .
RESULTS	APACHEII score , SOFA score , PaO2/FiO2 , ScvO2 , and Lac 48 hours after treatment were significantly improved in severe ARDS group compared with control group ( APACHEII score : 16.582.41 vs. 19.793.52 , t = 3.679 , P = 0.010 ; SOFA score : 12.042.17 vs. 14.753.26 , t = 3.385 , P = 0.010 ; PaO2/FiO2 : 159.3122.57 mmHg vs. 131.8134.93 mmHg , t = 3.239 , P = 0.020 ; ScvO2 : 0.6730.068 vs. 0.5720.142 , t = 3.137 , P = 0.030 ; Lac : 3.101.01 mmol/L vs. 4.391.72 mmol/L , t = 3.161 , P = 0.030 ) , while the value of CRP showed no significant difference ( 180.9137.14 mg/L vs. 174.6638.46 mg/L , t = 0.572 , P = 0.570 ) .
RESULTS	21-day mortality in treatment group was significantly lower than that in control group [ 20.8 % ( 5/24 ) vs. 50.0 % ( 12/24 ) , ( 2 ) = 4.463 , P = 0.035 ] .
RESULTS	In moderate ARDS group , each of the above clinical parameters were improved in both groups expect for CRP at 48 hours after treatment , but the indexes showed no statistically significant difference between two groups ( all P > 0.05 ) .
RESULTS	21-day mortality rate in the treatment group was slightly lower than that in the control group which showed no statistically significant difference [ 16.7 % ( 4/24 ) vs. 25.0 % ( 6/24 ) , ( 2 ) = 0.505 , P = 0.477 ] .
CONCLUSIONS	The early use of NMBA treatment of patients with severe sepsis and severe ARDS can not only improve the severity but also reduce 21-day mortality .

###25908099
BACKGROUND	Shivering is the most common complication during the recovery period after general anesthesia , and there is no clear consensus about the best strategy for its prophylactic .
BACKGROUND	The aim of the study was to evaluate the efficacy of parecoxib in prevention of postoperative shivering .
METHODS	Eighty patients with American Society of Anesthesiologists physical status I-II , who were scheduled for minor urological surgeries under general anesthesia , were randomly assigned to two groups ( n = 40 in each group ) : group P received 40 mg of parecoxib by intravenous bolus injection and group S received the same volume of normal saline in the same way just after the induction of anesthesia .
METHODS	Hemodynamic parameters and body temperatures including tympanic and axillary temperature were monitored .
METHODS	The occurrence of shivering and pain intensity score were recorded during the recovery period .
RESULTS	Parecoxib significantly reduced the incidence and severity of shivering in comparison with the placebo .
RESULTS	Postoperative shivering was observed in 22 patients in group S ( 55 % ) , compared with nine in group P ( 22.5 % ) ( P = 0.003 ) .
RESULTS	In addition , pain intensity scores were lower in group P during recovery period ; consequently , less rescue analgesics were required in group P when compared with group S ( P = 0.001 ) .
RESULTS	Regarding the body temperature , it was found that core temperature decreased but peripheral temperature increased significantly in both groups .
RESULTS	There was no significant difference between groups in all time intervals .
CONCLUSIONS	Prophylactic administration of parecoxib produces dual effects on antishivering and postoperative analgesia .
CONCLUSIONS	This implies that cyclooxygenase 2-prostaglandin E2 pathways may be involved in the regulation of shivering .

###26047319
BACKGROUND	We previously found that inflammation in benign prostate tissue is associated with an increased odds of prostate cancer , especially higher-grade disease .
BACKGROUND	Since part of this link may be due to genetics , we evaluated the association between single nucleotide polymorphisms ( SNPs ) in immune response genes and prostate cancer in the placebo arm of the Prostate Cancer Prevention Trial .
METHODS	We genotyped 16 candidate SNPs in IL1 , IL2 , IL4 , IL6 , IL8 , IL10 , IL12 ( p40 ) , IFNG , MSR1 , RNASEL , TLR4 , and TNFA and seven tagSNPs in IL10 in 881 prostate cancer cases and 848 controls negative for cancer on an end-of-study biopsy .
METHODS	Cases and controls were non-Hispanic white and frequency matched on age and family history .
METHODS	We classified cases as lower ( Gleason sum < 7 ; N = 674 ) and higher ( 7-10 ; N = 172 ) grade , and used logistic regression to estimate odds ratios ( OR ) and 95 % confidence intervals ( CI ) adjusting for age and family history .
RESULTS	The minor allele ( C ) of rs3212227 in IL12 ( p40 ) was associated with an increased risk of total ( log additive : OR = 1.30 , 95 % CI 1.10-1 .53 ; P-trend = 0.0017 ) and lower-grade ( OR = 1.36 , 95 % CI 1.15-1 .62 ; P-trend = 0.0004 ) prostate cancer .
RESULTS	The minor allele ( A ) of rs4073 in IL8 was possibly associated with a decreased risk of higher-grade ( OR = 0.81 , 95 % CI 0.64-1 .02 ; P-trend = 0.07 ) , but not total disease .
RESULTS	None of the other candidates was associated with risk .
RESULTS	The minor alleles of IL10 tagSNPs rs1800890 ( A ; OR = 0.87 , 95 % CI : 0.75-0 .99 ; P-trend = 0.04 ) and rs3021094 ( C ; OR = 1.31 , 95 % CI 1.03-1 .66 , P-trend = 0.03 ) were associated with risk ; the latter also with lower - ( P-trend = 0.04 ) and possibly higher - ( P-trend = 0.06 ) grade disease .
RESULTS	These patterns were similar among men with PSA < 2ng/ml at biopsy .
CONCLUSIONS	Variation in some immune response genes may be associated with prostate cancer risk .
CONCLUSIONS	These associations were not fully explained by PSA-associated detection bias .
CONCLUSIONS	Our findings generally support the role of inflammation in the etiology of prostate cancer .

###25085407
BACKGROUND	The objective of this study is to assess the index of decayed , missing and filled teeth ( DMF-T ) , habit of brushing teeth , and the microbiological agents accumulating on the children 's toothbrushes for 4 weeks and response of these agents to disinfection via a chlorhexidine solution , then compare those results with the education and income levels of the children 's parents .
METHODS	Included in the study were 187 children ( 96 in the control group and 91 in the experiment group - chlorhexidine ) chosen randomly from 600 kindergarten children whose ages ranged from 24 months to 72 months .
METHODS	The children selected had not taken any antibiotics , antimicotics for three months and dental treatments during this trial .
METHODS	The distribution of these children to the groups was also done randomly .
METHODS	After performing a survey for the education , occupation , and income status of the parents , the children were examined and the number of decayed teeth was recorded .
METHODS	The children were given toothbrushes , toothpaste ( with fluroide ) , and the solutions ( including distilled water and chlorhexidine ) for four weeks under the condition that toothbrushes were returned at the end of each week .
METHODS	The 14 different microbiological agents observed as a result of the assessment of the samples taken in the first week were also included in the assessments of the samples taken over the four-week period .
RESULTS	The decrease in the DMF-T index was found to be meaningful according to the differences in education , income , and occupation status of the parents .
RESULTS	Of all the samples taken from the toothbrushes , the bacteria with the greatest rate of reproduction included Streptococcus mutans , Escherichia Coli , Pseudomonas aeuroginosa , Enterococcus spp , Staphylococcus epidermidis and Candida albicans .
RESULTS	Except for Candida albicans , the other microorganisms taken as samples from the toothbrushes reproduced less overall .
RESULTS	In the group using the solution with chlorhexidine , a meaningful decrease in bacterial reproduction was discovered compared to the control group .
CONCLUSIONS	The findings of this study show that the education , occupation , and socioeconomic situations of the parents should be considered when discussing children 's oral and dental health .
CONCLUSIONS	Moreover , the study shows that disinfection of toothbrushes in order to prevent reinfection and contamination oral flora with the bacteria again is important in terms of preventive medicine and family-children health .

###25762753
BACKGROUND	Although the evidence is mixed , female smokers appear to have more difficulty quitting smoking than male smokers .
BACKGROUND	Craving , stress , and negative affect have been hypothesized as potential factors underlying gender differences in quit rates .
METHODS	In the current study , the cue-reactivity paradigm was used to assess craving , stress , and negative affect in response to cues presented in the natural environment of cigarette smokers using ecological momentary assessment .
METHODS	Seventy-six daily smokers ( 42 % female ) responded to photographs ( smoking , stress , and neutral ) presented 4 times per day on an iPhone over the course of 2 weeks .
RESULTS	Both smoking and stress cues elicited stronger cigarette craving and stress responses compared to neutral cues .
RESULTS	Compared with males , females reported higher levels of post-stress cue craving , stress , and negative affect , but response to smoking cues did not differ by gender .
CONCLUSIONS	Findings from this project were largely consistent with results from laboratory-based research and extend previous work by measuring response to cues in the natural environment of cigarette smokers .
CONCLUSIONS	This study extends previous cue reactivity ecological momentary assessment research by using a new platform and by measuring response to stress cues outside of the laboratory .
CONCLUSIONS	Findings from this project highlight the importance of addressing coping in response to stress cues in clinical settings , especially when working with female smokers .

###24969672
BACKGROUND	Fundamentals of Laparoscopic Surgery ( FLS ) certification is required for general surgery .
BACKGROUND	The recommended practice for learning FLS is to practice tasks one at a time until proficient ( blocked practice ) .
BACKGROUND	Learning theory suggests that interleaved practice , a method in which tasks are rotated rather than learned one at a time , may result in superior learning .
METHODS	Residents were randomized into 1 of 2 groups : blocked practice or interleaved practice .
METHODS	We compared the performance of residents across groups over 20 trials of each of 4 FLS tasks ( peg transfer , pattern cut , extracorporeal suture , and intracorporeal suture ) .
METHODS	Four weeks later , participants returned to the laboratory and completed 2 additional trials of each of the 4 tasks .
RESULTS	Performance on each of the tasks improved with increased practice .
RESULTS	The interleaved group showed significantly better performance on the peg transfer task ; trends favoring the interleaved group resulted for the other tasks .
RESULTS	Standardized mean differences in favor of the interleaved group were substantial both at the end of practice and at follow-up ( with the exception of the pattern cut ) .
CONCLUSIONS	Interleaved practice appears to have advantages over blocked practice in developing and retaining FLS skills .
CONCLUSIONS	We encourage others to experiment with the method to confirm our findings .

###25295681
OBJECTIVE	Bipolar disorder places a significant burden on individuals , caregivers and family , and the broader community .
OBJECTIVE	Current treatments are believed to be more effective against manic symptoms , leaving a shortfall in recovery during the depressive phase of the illness .
OBJECTIVE	The current study draws on recent evidence suggesting that , in addition to increased oxidative load , alterations in mitochondrial function occur in bipolar disorder .
METHODS	This 16-week study aims to explore the potential benefits of N-acetylcysteine ( NAC ) alone or in combination ( CT ) with selected nutraceuticals believed to enhance mitochondrial function .
METHODS	The study includes adults diagnosed with bipolar disorder currently experiencing an episode of depression .
METHODS	Participants are asked to take NAC , CT , or placebo in addition to any usual treatments .
METHODS	A post-discontinuation visit is conducted 4 weeks following the treatment phase .
RESULTS	The primary outcome of the study will be mean change on the Montgomery-Asberg Depression Rating Scale .
RESULTS	Secondary outcomes include functioning , substance use , mania ratings , and quality of life .
RESULTS	Blood samples will be collected at baseline and week 16 to explore biochemical alterations following treatment .
CONCLUSIONS	This study may provide a novel adjunctive treatment for bipolar depression .
CONCLUSIONS	Analysis of biological samples may assist in understanding the therapeutic benefits and the underlying etiology of bipolar depression .
BACKGROUND	Australian and New Zealand Clinical Trial Registry ACTRN12612000830897 .

###25348244
OBJECTIVE	Compare auto-adjusting positive airway pressure ( APAP ) treatment with positive airway pressure ( PAP ) titration by polysomnography ( PSG ) followed by CPAP treatment in patients diagnosed with obstructive sleep apnea ( OSA ) by home sleep apnea testing ( HSAT ) .
METHODS	Prospective randomized treatment study .
METHODS	Tertiary Veterans Administration Medical Center .
METHODS	156 patients diagnosed with OSA by HSAT ( apneahypopnea index [ AHI ] 10/h ) suitable for APAP treatment .
METHODS	APAP arm : Treatment with an APAP device , CPAP arm : PSG PAP titration followed by CPAP treatment .
METHODS	Mean PAP adherence , Epworth sleepiness scale ( ESS ) , Functional Outcomes of Sleep Questionnaire ( FOSQ ) .
RESULTS	The mean ( SD ) age , BMI , and diagnostic AHI ( APAP : 28.6 18.5 , CPAP : 28.3 16.0 / h , p = NS ) did not differ between the study arms .
RESULTS	After 6 weeks of treatment , 84.6 % of 78 patients started on APAP and 84.3 % of 70 patients started on CPAP ( 8 declined treatment after the titration ) were using PAP , p = NS .
RESULTS	The 90 % APAP and level of CPAP were similar ( 10.8 3.1 , 11.7 2.5 cm H2O , p = 0.07 ) .
RESULTS	The average nightly PAP use did not differ ( APAP : 4.45 2.3 , CPAP : 4.0 2.3 h , p = NS ) .
RESULTS	The improvements in the ESS ( APAP : -4.2 4.7 , CPAP : -3.7 4.8 , p = NS ) and in the FOSQ ( APAP : 2.6 3.5 , CPAP : 2.2 3.7 , p = NS ) were not different .
CONCLUSIONS	Following diagnosis of OSA by HSAT , treatment with APAP results in equivalent PAP adherence and improvement in sleepiness compared to a PSG titration and CPAP treatment .
CONCLUSIONS	A commentary on this article appears in this issue on page 1277 .

###24219814
BACKGROUND	Repeated courses of intravenous ( IV ) aminoglycosides in cystic fibrosis ( CF ) patients are associated with cumulative nephrotoxicity .
BACKGROUND	Targeting their delivery through the inhaled route during acute pulmonary exacerbations may also be effective , but without systemic side effects .
METHODS	Using a randomized crossover trial design , in a pilot study we compared 14 days of IV tobramycin with nebulized tobramycin 300mg twice a day ( TNS ) in acute respiratory exacerbations in 20 CF adults chronically infected with Pseudomonas aeruginosa ( Psa ) .
METHODS	Patients also received IV colistin in both arms .
RESULTS	Improvement in spirometry was similar between the two groups [ mean change in FEV1 % predicted : IV group 16.4 ( standard deviation 8.5 ) versus TNS group 19.9 ( 11.3 ) , p = 0.26 ] , but there was more suppression of sputum Psa in the TNS group [ mean difference between treatments 0.85 log10 colony-forming units/mL ( CI 0.03 to 1.67 ) , p = 0.05 ] .
RESULTS	IV tobramycin was associated with a greater urinary protein leak [ mean difference between treatments 0.59 mg/24hr ( 0.30 to 0.87 ) , p = 0.0005 ] and higher urinary levels of markers of acute renal tubular injury : N-acetylglucosaminidase [ 0.72 IU/mmol ( 0.37 to 1.07 ) , p = 0.0004 ] , alanine aminopeptidase [ 1.19 IU/mmol ( 0.70 to 1.68 ) , p = 0.0001 ] , and 2-microglobulin [ 0.44 g/mmol ( 0.16 to 0.72 ) , p = 0.0046 ] than TNS .
RESULTS	Compared with IV tobramycin , TNS treatment prolonged the time to next exacerbation requiring hospitalization ( p < 0.001 ) .
RESULTS	Patient satisfaction was similar with both treatments , and no serious adverse effects were recorded .
CONCLUSIONS	TNS is effective in treating acute exacerbations of Psa in CF patients , but with a renal sparing potential compared with the IV preparation .

###24259108
BACKGROUND	Laser beam diameter affects the depth of laser penetration .
BACKGROUND	Q-switched lasers tend to have smaller maximum spot sizes than other dermatologic lasers , making beam diameter a potentially more significant factor in treatment outcomes .
OBJECTIVE	To compare the clinical effect of using the maximum-size treatment beam available for each delivered fluence during laser tattoo removal to a standard 4-mm-diameter treatment beam .
METHODS	Thirteen tattoos were treated in 12 subjects using a Q-switched Nd : YAG laser equipped with a treatment beam diameter that was adjustable in 1mm increments and a setting that would enable the maximally achievable diameter ( `` MAX-ON '' setting ) with any fluence .
METHODS	Tattoos were randomly bisected and treated on one side with the MAX-ON setting and on the contralateral side with a standard 4-mm-diameter spot ( `` MAX-OFF '' setting ) .
METHODS	Photographs were taken 8 weeks following each treatment and each half-tattoo was evaluated for clearance on a 10-point scale by physicians blinded to the treatment conditions .
RESULTS	Tattoo clearance was greater on the side treated with the MAX-ON setting in a statistically significant manner following the 1st through 4th treatments , with the MAX-OFF treatment site approaching the clearance of the MAX-ON treatment site after the 5th and 6th treatments .
CONCLUSIONS	This high-energy , Q-switched Nd : YAG laser with a continuously variable spot-size safely and effectively removes tattoos , with greater removal when using a larger spot-size .

###25261605
OBJECTIVE	To investigate the feasibility of delivering titrated oxygen therapy to adults with return of spontaneous circulation ( ROSC ) following out-of-hospital cardiac arrest ( OHCA ) caused by ventricular fibrillation ( VF ) or ventricular tachycardia ( VT ) .
METHODS	We used a multicentre , randomised , single blind , parallel groups design to compare titrated and standard oxygen therapy in adults resuscitated from VF/VT OHCA .
METHODS	The intervention commenced in the community following ROSC and was maintained in the emergency department and the Intensive Care Unit .
METHODS	The primary end point was the median oxygen saturation by pulse oximetry ( SpO2 ) in the pre-hospital period .
RESULTS	159 OHCA patients were screened and 18 were randomised .
RESULTS	17 participants were analysed : nine in the standard care group and eight in the titrated oxygen group .
RESULTS	In the pre-hospital period , SpO2 measurements were lower in the titrated oxygen therapy group than the standard care group ( difference in medians 11.3 % ; 95 % CI 1.0-20 .5 % ) .
RESULTS	Low measured oxygen saturation ( SpO2 < 88 % ) occurred in 7/8 of patients in the titrated oxygen group and 3/9 of patients in the standard care group ( P = 0.05 ) .
RESULTS	Following hospital admission , good separation of oxygen exposure between the groups was achieved without a significant increase in hypoxia events .
RESULTS	The trial was terminated because accumulated data led the Data Safety Monitoring Board and Management Committee to conclude that safe delivery of titrated oxygen therapy in the pre-hospital period was not feasible .
CONCLUSIONS	Titration of oxygen in the pre-hospital period following OHCA was not feasible ; it may be feasible to titrate oxygen safely after arrival in hospital .

###25349008
BACKGROUND	Recent warnings from Health Canada regarding codeine for children have led to increased use of nonsteroidal anti-inflammatory drugs and morphine for common injuries such as fractures .
BACKGROUND	Our objective was to determine whether morphine administered orally has superior efficacy to ibuprofen in fracture-related pain .
METHODS	We used a parallel group , randomized , blinded superiority design .
METHODS	Children who presented to the emergency department with an uncomplicated extremity fracture were randomly assigned to receive either morphine ( 0.5 mg/kg orally ) or ibuprofen ( 10 mg/kg ) for 24 hours after discharge .
METHODS	Our primary outcome was the change in pain score using the Faces Pain Scale - Revised ( FPS-R ) .
METHODS	Participants were asked to record pain scores immediately before and 30 minutes after receiving each dose .
RESULTS	We analyzed data from 66 participants in the morphine group and 68 participants in the ibuprofen group .
RESULTS	For both morphine and ibuprofen , we found a reduction in pain scores ( mean pre-post difference standard deviation for dose 1 : morphine 1.5 1.2 , ibuprofen 1.3 1.0 , between-group difference [ ] 0.2 [ 95 % confidence interval ( CI ) -0.2 to 0.6 ] ; dose 2 : morphine 1.3 1.3 , ibuprofen 1.3 0.9 , 0 [ 95 % CI -0.4 to 0.4 ] ; dose 3 : morphine 1.3 1.4 , ibuprofen 1.4 1.1 , -0.1 [ 95 % CI -0.7 to 0.4 ] ; and dose 4 : morphine 1.5 1.4 , ibuprofen 1.1 1.2 , 0.4 [ 95 % CI -0.2 to 1.1 ] ) .
RESULTS	We found no significant differences in the change in pain scores between morphine and ibuprofen between groups at any of the 4 time points ( p = 0.6 ) .
RESULTS	Participants in the morphine group had significantly more adverse effects than those in the ibuprofen group ( 56.1 % v. 30.9 % , p < 0.01 ) .
CONCLUSIONS	We found no significant difference in analgesic efficacy between orally administered morphine and ibuprofen .
CONCLUSIONS	However , morphine was associated with a significantly greater number of adverse effects .
CONCLUSIONS	Our results suggest that ibuprofen remains safe and effective for outpatient pain management in children with uncomplicated fractures .
BACKGROUND	ClinicalTrials.gov , no .
BACKGROUND	NCT01690780 .

###24226805
BACKGROUND	In patients with acute pulmonary embolism , systemic thrombolysis improves right ventricular ( RV ) dilatation , is associated with major bleeding , and is withheld in many patients at risk .
BACKGROUND	This multicenter randomized , controlled trial investigated whether ultrasound-assisted catheter-directed thrombolysis ( USAT ) is superior to anticoagulation alone in the reversal of RV dilatation in intermediate-risk patients .
RESULTS	Fifty-nine patients ( 6314 years ) with acute main or lower lobe pulmonary embolism and echocardiographic RV to left ventricular dimension ( RV/LV ) ratio 1.0 were randomized to receive unfractionated heparin and an USAT regimen of 10 to 20 mg recombinant tissue plasminogen activator over 15 hours ( n = 30 ; USAT group ) or unfractionated heparin alone ( n = 29 ; heparin group ) .
RESULTS	Primary outcome was the difference in the RV/LV ratio from baseline to 24 hours .
RESULTS	Safety outcomes included death , major and minor bleeding , and recurrent venous thromboembolism at 90 days .
RESULTS	In the USAT group , the mean RV/LV ratio was reduced from 1.280.19 at baseline to 0.990.17 at 24 hours ( P < 0.001 ) ; in the heparin group , mean RV/LV ratios were 1.200.14 and 1.170.20 , respectively ( P = 0.31 ) .
RESULTS	The mean decrease in RV/LV ratio from baseline to 24 hours was 0.300.20 versus 0.030.16 ( P < 0.001 ) , respectively .
RESULTS	At 90 days , there was 1 death ( in the heparin group ) , no major bleeding , 4 minor bleeding episodes ( 3 in the USAT group and 1 in the heparin group ; P = 0.61 ) , and no recurrent venous thromboembolism .
CONCLUSIONS	In patients with pulmonary embolism at intermediate risk , a standardized USAT regimen was superior to anticoagulation with heparin alone in reversing RV dilatation at 24 hours , without an increase in bleeding complications .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01166997 .

###25335244
OBJECTIVE	To observe the impacts on the recovery of swallowing function in patients of dysphagia after acute stroke treated with acupuncture and functional electric stimulation .
METHODS	Seventy-four patients were randomized into an acupuncture plus electric stimulation group ( 38 cases ) and an electric stimulation group ( 36 cases ) .
METHODS	The functional electric stimulator was used in the two groups .
METHODS	The electric pads were placed on the hyoid bone , the upper part of thyroid cartilage , the masseter muscle and the mandibular joint .
METHODS	The treatment lasted for 30 mm each time .
METHODS	In the acupuncture plus electric stimulation group , acupuncture was supplemented at motor area of Jiao 's scalp acupuncture , lower 2/5 of sensory area , Baihui ( CV 20 ) , Lianquan ( CV 23 ) , Jinjin ( EX-HN 12 ) and Yuye ( EX-HN 13 ) , 30 mm each time .
METHODS	The treatment was given once a day , 6 treatments for one session and there was 1 day at interval between the sessions , 4 sessions were required totally in the two groups .
METHODS	The dysphagia scale was adopted for efficacy evaluation before treatment and after 4 sessions of treatment in the two groups .
METHODS	The removal rate of nasal feeding tube was observed after treatment .
RESULTS	The dysphagia score was increased apparently after treatment compared with that before treatment in the two groups ( both P < 0.05 ) .
RESULTS	After treatment , in the acupuncture plus electric stimulation group , the dysphagia score was increased much more apparently than that in the electric stimulation group ( 8.01 + / - 1.25 vs 6.73 + / - 1.36 , P < 0.05 ) .
RESULTS	The remarkably effective rate was 84.2 % ( 32/38 ) in the acupuncture plus electric stimulation group , better than 58.3 % ( 21/36 ) in the electric stimulation group ( P < 0.05 ) .
RESULTS	The removal rate of nasal feeding tube was 89.5 % ( 34/38 ) in the acupuncture plus electric stimulation group , which was higher than 50.0 % ( 18/36 ) in the electric stimulation group ( P < 0.05 ) .
CONCLUSIONS	Acupuncture combined with electric stimulation achieves the much better efficacy on dysphagia after acute stroke and promotes the early removal of nasal feeding tube .
CONCLUSIONS	The efficacy is better than that of the simple electric stimulation therapy .

###25147070
BACKGROUND	Experimental studies demonstrate that higher intake of omega-3 fatty acids ( n-3 FA ) improves insulin sensitivity , however , we reported that n-3 FA 2g therapy , most commonly used dosage did not significantly improve insulin sensitivity despite reducing triglycerides by 21 % in patients .
BACKGROUND	Therefore , we investigated the effects of different dosages of n-3 FA in patients with hypertriglyceridemia .
METHODS	This was a randomized , single-blind , placebo-controlled , parallel study .
METHODS	Age , sex , and body mass index were matched among groups .
METHODS	All patients were recommended to maintain a low fat diet .
METHODS	Forty-four patients ( about 18 had metabolic syndrome/type 2 diabetes mellitus ) in each group were given placebo , n-3 FA 1 ( O1 ) , 2 ( O2 ) , or 4 g ( O4 ) , respectively daily for 2 months .
RESULTS	n-3 FA therapy dose-dependently and significantly decreased triglycerides and triglycerides/HDL cholesterol and improved flow-mediated dilation , compared with placebo ( by ANOVA ) .
RESULTS	However , each n-3 FA therapy did not significantly decrease high-sensitivity C-reactive protein and fibrinogen , compared with placebo .
RESULTS	O1 significantly increased insulin levels and decreased insulin sensitivity ( determined by QUICKI ) and O2 significantly decreased plasma adiponectin levels relative to baseline measurements .
RESULTS	Of note , when compared with placebo , each n-3 FA therapy did not significantly change insulin , glucose , adiponectin , glycated hemoglobin levels and insulin sensitivity ( by ANOVA ) .
RESULTS	We observed similar results in a subgroup of patients with the metabolic syndrome .
CONCLUSIONS	n-3 FA therapy dose-dependently and significantly decreased triglycerides and improved flow-mediated dilation .
CONCLUSIONS	Nonetheless , n-3 FA therapy did not significantly improve acute-phase reactants and insulin sensitivity in patients with hypertriglyceridemia , regardless of dosages .

###25425136
BACKGROUND	Benign prostatic hyperplasia ( BPH ) is a prevalent entity in elderly men and transurethral resection of the prostate ( TURP ) still represents the gold standard of surgical treatment despite its considerable perioperative morbidity .
BACKGROUND	Recently , prostatic artery embolization ( PAE ) was described as a novel effective and less invasive treatment alternative .
BACKGROUND	Despite promising first results , PAE still has to be considered experimental due to a lack of good quality studies .
BACKGROUND	Prospective randomized controlled trials comparing PAE with TUR-P are highly warranted .
METHODS	This is a single-centre , prospective , randomized , non-inferiority trial comparing treatment effects and adverse events of PAE and TURP in a tertiary referral centre .
METHODS	One hundred patients who are electable for both treatment options are randomized to either PAE or TURP .
METHODS	Changes of the International Prostate Symptom Score ( IPSS ) after 3 months are defined as primary endpoint .
METHODS	Changes in bladder diaries , laboratory analyses , urodynamic investigations and standardised questionnaires are assessed as secondary outcome measures .
METHODS	In addition contrast-enhanced magnetic resonance imaging of the pelvis before and after the interventions will provide crucial information regarding morphological changes and vascularisation of the prostate .
METHODS	Adverse events will be assessed on every follow-up visit in both treatment arms according to the National Cancer Institute Common Terminology Criteria for Adverse events and the Clavien classification .
CONCLUSIONS	The aim of this study is to assess whether PAE represents a valid treatment alternative to TURP in patients suffering from BPH in terms of efficacy and safety .
BACKGROUND	ClinicalTrials.gov NCT02054013 .

###25260214
OBJECTIVE	The current study examined 11 male veterans with military sexual trauma ( MST ) - related posttraumatic stress disorder ( PTSD ) who participated in a larger randomized control trial comparing cognitive processing therapy ( CPT ) to a well-established control treatment ( Present Centered Therapy ; PCT ) among men and women with MST-related PTSD .
METHODS	All participants ( n = 11 ) completed a 12 session protocol of CPT .
METHODS	The Clinician Administered PTSD Scale ( CAPS ) , PTSD Checklist ( PCL ) , and Quick Inventory of Depressive Symptomatology ( QIDS ) were administered at baseline and post-treatment sessions 2 , 4 , and 6 months after CPT completion .
METHODS	Additionally , the PCL and QIDS were administered every two sessions during CPT treatment .
RESULTS	Piecewise growth curve analyses revealed that significant change over time in both PTSD and depressive symptoms was associated with the active treatment phase and that participants maintained treatment gains over the 6-month follow-up period .
CONCLUSIONS	CPT effectively reduced self-reported symptoms of PTSD as well as depressive symptoms for men with MST-related PTSD .
CONCLUSIONS	Additionally , participants maintained the gains they made during treatment over a 6-month follow-up period .
CONCLUSIONS	It is recommended that future studies examine patient characteristics that might impact outcome in order to improve understanding of who benefits the most from treatment .

###25564570
OBJECTIVE	To determine if phosphodiesterase 5 ( PDE5 ) inhibitors can augment immune function in patients with head and neck cancer through inhibition of myeloid-derived suppressor cells ( MDSC ) .
METHODS	We performed a randomized , prospective , double blinded , placebo controlled , phase II clinical trial to determine the in vivo effects of systemic PDE5 inhibition on immune function in patients with head and neck squamous cell carcinoma ( HNSCC ) .
RESULTS	Tadalafil augmented immune response , increasing ex vivo T-cell expansion to a mean 2.4-fold increase compared with 1.1-fold in control patients ( P = 0.01 ) , reducing peripheral MDSC numbers to mean 0.81-fold change compared with a 1.26-fold change in control patients ( P = 0.001 ) , and increasing general immunity as measured by delayed type hypersensitivity response ( P = 0.002 ) .
RESULTS	Tumor-specific immunity in response to HNSCC tumor lysate was augmented in tadalafil-treated patients ( P = 0.04 ) .
CONCLUSIONS	These findings demonstrate that tadalafil augments general and tumor-specific immunity in patients with HNSCC and has therapeutic potential in HNSCC .
CONCLUSIONS	Evasion of immune surveillance and suppression of systemic and tumor-specific immunity is a significant feature of head and neck cancer development .
CONCLUSIONS	This study demonstrates that a PDE5 inhibitor , tadalafil , can reverse tumor-specific immune suppression in patients with head and neck cancer , with potential for therapeutic application .

###24795200
BACKGROUND	The interferon-free regimen of ABT-450 with ritonavir ( ABT-450 / r ) , ombitasvir , and dasabuvir with or without ribavirin has shown efficacy in inducing a sustained virologic response in a phase 2 study involving patients with hepatitis C virus ( HCV ) genotype 1 infection .
BACKGROUND	We conducted two phase 3 trials to examine the efficacy and safety of this regimen in previously untreated patients with HCV genotype 1 infection and no cirrhosis .
METHODS	We randomly assigned 419 patients with HCV genotype 1b infection ( PEARL-III study ) and 305 patients with genotype 1a infection ( PEARL-IV study ) to 12 weeks of ABT-450 / r-ombitasvir ( at a once-daily dose of 150 mg of ABT-450 , 100 mg of ritonavir , and 25 mg of ombitasvir ) , dasabuvir ( 250 mg twice daily ) , and ribavirin administered according to body weight or to matching placebo for ribavirin .
METHODS	The primary efficacy end point was a sustained virologic response ( an HCV RNA level of < 25 IU per milliliter ) 12 weeks after the end of treatment .
RESULTS	The study regimen resulted in high rates of sustained virologic response among patients with HCV genotype 1b infection ( 99.5 % with ribavirin and 99.0 % without ribavirin ) and among those with genotype 1a infection ( 97.0 % and 90.2 % , respectively ) .
RESULTS	Of patients with genotype 1b infection , 1 had virologic failure , and 2 did not have data available at post-treatment week 12 .
RESULTS	Among patients with genotype 1a infection , the rate of virologic failure was higher in the ribavirin-free group than in the ribavirin group ( 7.8 % vs. 2.0 % ) .
RESULTS	In both studies , decreases in the hemoglobin level were significantly more common in patients receiving ribavirin .
RESULTS	Two patients ( 0.3 % ) discontinued the study drugs owing to adverse events .
RESULTS	The most common adverse events were fatigue , headache , and nausea .
CONCLUSIONS	Twelve weeks of treatment with ABT-450 / r-ombitasvir and dasabuvir without ribavirin was associated with high rates of sustained virologic response among previously untreated patients with HCV genotype 1 infection .
CONCLUSIONS	Rates of virologic failure were higher without ribavirin than with ribavirin among patients with genotype 1a infection but not among those with genotype 1b infection .
CONCLUSIONS	( Funded by AbbVie ; PEARL-III and PEARL-IV ClinicalTrials.gov numbers , NCT01767116 and NCT01833533 . )

###25741444
OBJECTIVE	To examine costs associated with obesity in an employee population and factors associated with increased costs .
METHODS	We used data from the Physical Activity and Life Style ( PALS ) study , a randomized prospective design evaluating three interventions to increase physical activity among physically inactive nonfaculty university employees ( n = 454 ) .
METHODS	The primary exposure variable , obesity ( measured by body mass index ) , was obtained from the in-person baseline survey .
METHODS	Covariates were obtained from the baseline survey and included demographic characteristics and health status .
METHODS	Data from the baseline survey was linked with administrative data to determine pharmaceutical , inpatient , outpatient , and total health care costs for three years .
METHODS	Average monthly expenditures for obese and nonobese individuals were compared using t-tests and a two-part multivariate regression model adjusted for demographic and socioeconomic characteristics and health behaviors .
RESULTS	Although in-patient and outpatient expenses were not associated with obesity , pharmaceutical expenditures were $ 408 or 87.2 % higher per year ( $ 468 versus $ 876 ) for obese individuals than for nonobese individuals , which reflected poorer health behaviors and health status of obese adults .
CONCLUSIONS	Awareness of the costs associated with obesity among employees can stimulate employers to make the investment in providing employer-sponsored wellness and health improvement programs to address obesity .

###25524686
OBJECTIVE	Improved understanding of presurgical risk factors for transfusions will lead to reduction in their number and related complications .
OBJECTIVE	The goal of this study is to identify these factors in coronary artery bypass graft ( CABG ) surgery .
METHODS	Presented herein are results of analyses of data from an ongoing study of transfusion in CABG surgery .
METHODS	Of 122 patients , 81 received transfusion ( Tx ) and 41 did not ( NoTx ) .
METHODS	In addition to routine tests , presurgical levels of microparticles from platelets ( PMPs ) , red cells ( RMPs ) , and other lineages were assayed .
RESULTS	The Tx and NoTx groups were similar with respect to most presurgical variables but differed in distribution of gender , blood type , diabetes prevalence , activated partial thromboplastin time ( aPTT ) , hemoglobin ( HGB ) , and microparticle levels .
RESULTS	Stepwise multiple logistic regression was used to evaluate presurgical variables and to develop a model to assess risk factors for transfusion .
RESULTS	CD41 ( + ) PMP and CD235 ( + ) RMP levels were found to be the main risk factors for transfusion .
RESULTS	The Model 's discriminating ability was assessed using receiver operating characteristic curve analysis , which showed that the area under the model curve ( standard error ) was 0.86 0.04 ( 95 % confidence interval , 0.77-0 .94 ) .
RESULTS	According to the model , patients with higher presurgical levels of circulating CD41 ( + ) PMP , CD235a ( + ) RMP , and HGB , as well as a shorter aPTT , are less likely to receive transfusion ( s ) .
CONCLUSIONS	Presurgical levels of CD41 ( + ) PMPs and CD235a ( + ) RMPs are the main risk factors for transfusion in CABG , followed by HGB and aPTT .

###24549033
OBJECTIVE	To examine the effect of a 1-yr school-based intervention program to prevent the development of new cases of eating disorders ( ED ) and symptoms associated with ED among adolescent female and male elite athletes .
METHODS	All 16 Norwegian Elite Sport High Schools were included ( intervention group [ n = 9 ] and control group [ n = 7 ] ) .
METHODS	In total , 465 ( 93.8 % ) first-year student athletes were followed during high school ( 2008-2011 , three school years ) .
METHODS	The athletes completed the Eating Disorder Inventory 2 and questions related to ED before ( pretest ) , immediately after ( posttest 1 ) , and 9 months after the intervention ( posttest 2 ) .
METHODS	Clinical interviews ( Eating Disorder Examination ) were conducted after the pretest ( all with symptoms [ n = 115 , 97 % ] and a random sample without symptoms [ n = 116 , 97 % ] ) , and at posttest 2 , all athletes were interviewed ( n = 463 , 99.6 % ) .
RESULTS	Among females , there were no new cases of ED in the intervention schools , while 13 % at the control schools had developed and fulfilled the DSM-IV criteria for ED not otherwise specified ( n = 7 ) or bulimia nervosa ( n = 1 ) , P = 0.001 .
RESULTS	The risk of reporting symptoms was lower in the intervention than in the control schools at posttest 1 ( odds ratio [ OR ] = 0.45 , 95 % confidence interval [ CI ] = 0.23-0 .89 ) .
RESULTS	This effect was attenuated by posttest 2 ( OR = 0.57 , 95 % CI = 0.29-1 .09 ) .
RESULTS	The intervention showed a relative risk reduction for current dieting ( OR = 0.10 , 95 % CI = 0.02-0 .54 ) and three or more weight loss attempts ( OR = 0.47 , 95 % CI = 0.25-0 .90 ) .
RESULTS	Among males , there was one new case of ED at posttest 2 ( control school ) and no difference in the risk of reporting symptoms between groups at posttest 1 or 2 .
CONCLUSIONS	A 1-yr intervention program can prevent new cases of ED and symptoms associated with ED in adolescent female elite athletes .

###24707819
OBJECTIVE	To determine the effect of maternal presence on the physiological and behavioral status of the preterm infant when exposed to recorded music versus ambient sound .
METHODS	Repeated-measures randomized controlled trial .
METHODS	Special care nursery ( SCN ) in a tertiary perinatal center .
METHODS	Clinically stable preterm infants ( 22 ) born at > 28 weeks gestation and enrolled at > 32 weeks gestation and their mothers .
METHODS	Infants were exposed to lullaby music ( 6 minutes of ambient sound alternating with 2x 6 minutes recorded lullaby music ) at a volume within the recommended sound level for the SCN .
METHODS	The mothers in the experimental group were present for the first 12 minutes ( baseline and first music period ) whereas the mothers in the control group were absent overall .
RESULTS	There was no discernible infant response to music and therefore no significant impact of maternal presence on infant 's response to music over time .
RESULTS	However during the mothers ' presence ( first 12 minutes ) , the infants exhibited significantly higher oxygen saturation than during their absence p = .024 ) and less time spent in quiet sleep after their departure , though this was not significant .
CONCLUSIONS	Infants may have been unable to detect the music against the ambient soundscape .
CONCLUSIONS	Regardless of exposure to music , the infants ' physiological and behavioral regulation were affected by the presence and departure of the mothers .

###26189067
BACKGROUND	Preoperative chemoradiotherapy with infusional fluorouracil , total mesorectal excision surgery , and postoperative chemotherapy with fluorouracil was established by the German CAO/ARO/AIO -94 trial as a standard combined modality treatment for locally advanced rectal cancer .
BACKGROUND	Here we compare the previously established regimen with an investigational regimen in which oxaliplatin was added to both preoperative chemoradiotherapy and postoperative chemotherapy .
METHODS	In this multicentre , open-label , randomised , phase 3 study we randomly assigned patients with rectal adenocarcinoma , clinically staged as cT3-4 or any node-positive disease , to two groups : a control group receiving standard fluorouracil-based combined modality treatment , consisting of preoperative radiotherapy of 504 Gy in 28 fractions plus infusional fluorouracil ( 1000 mg/m ( 2 ) on days 1-5 and 29-33 ) , followed by surgery and four cycles of bolus fluorouracil ( 500 mg/m ( 2 ) on days 1-5 and 29 ) ; or to an investigational group receiving preoperative radiotherapy of 504 Gy in 28 fractions plus infusional fluorouracil ( 250 mg/m ( 2 ) on days 1-14 and 22-35 ) and oxaliplatin ( 50 mg/m ( 2 ) on days 1 , 8 , 22 , and 29 ) , followed by surgery and eight cycles of oxaliplatin ( 100 mg/m ( 2 ) on days 1 and 15 ) , leucovorin ( 400 mg/m ( 2 ) on days 1 and 15 ) , and infusional fluorouracil ( 2400 mg/m ( 2 ) on days 1-2 and 15-16 ) .
METHODS	Randomisation was done with computer-generated block-randomisation codes stratified by centre , clinical T category ( cT1-3 vs cT4 ) , and clinical N category ( cN0 vs cN1-2 ) without masking .
METHODS	The primary endpoint was disease-free survival , defined as the time between randomisation and non-radical surgery of the primary tumour ( R2 resection ) , locoregional recurrence after R0/1 resection , metastatic disease or progression , or death from any cause , whichever occurred first .
METHODS	Survival and cumulative incidence of recurrence analyses followed the intention-to-treat principle ; toxicity analyses included all patients treated .
METHODS	Enrolment of patients in this trial is completed and follow-up is ongoing .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00349076 .
RESULTS	Of the 1265 patients initially enrolled , 1236 were assessable ( 613 in the investigational group and 623 in the control group ) .
RESULTS	With a median follow-up of 50 months ( IQR 38-61 ) , disease-free survival at 3 years was 759 % ( 95 % CI 724-795 ) in the investigational group and 712 % ( 95 % CI 676-749 ) in the control group ( hazard ratio [ HR ] 079 , 95 % CI 064-098 ; p = 003 ) .
RESULTS	Preoperative grade 3-4 toxic effects occurred in 144 ( 24 % ) of 607 patients who actually received fluorouracil and oxaliplatin during chemoradiotherapy and in 128 ( 20 % ) of 625 patients who actually received fluorouracil chemoradiotherapy .
RESULTS	Of 445 patients who actually received adjuvant fluorouracil and leucovorin and oxaliplatin , 158 ( 36 % ) had grade 3-4 toxic effects , as did 170 ( 36 % ) of 470 patients who actually received adjuvant fluorouracil .
RESULTS	Late grade 3-4 adverse events in patients who received protocol-specified preoperative and postoperative treatment occurred in 112 ( 25 % ) of 445 patients in the investigational group , and in 100 ( 21 % ) of 470 patients in the control group .
CONCLUSIONS	Adding oxaliplatin to fluorouracil-based neoadjuvant chemoradiotherapy and adjuvant chemotherapy ( at the doses and intensities used in this trial ) significantly improved disease-free survival of patients with clinically staged cT3-4 or cN1-2 rectal cancer compared with our former fluorouracil-based combined modality regimen ( based on CAO/ARO/AIO -94 ) .
CONCLUSIONS	The regimen established by CAO/ARO/AIO -04 can be deemed a new treatment option for patients with locally advanced rectal cancer .
BACKGROUND	German Cancer Aid ( Deutsche Krebshilfe ) .

###25599828
BACKGROUND	Web-based , computer-tailored nutrition education interventions can be effective in modifying self-reported dietary behaviors .
BACKGROUND	Traditional computer-tailored programs primarily targeted individual cognitions ( knowledge , awareness , attitude , self-efficacy ) .
BACKGROUND	Tailoring on additional variables such as self-regulation processes and environmental-level factors ( the home food environment arrangement and perception of availability and prices of healthy food products in supermarkets ) may improve efficacy and effect sizes ( ES ) of Web-based computer-tailored nutrition education interventions .
OBJECTIVE	This study evaluated the short - and medium-term efficacy and educational differences in efficacy of a cognitive and environmental feedback version of a Web-based computer-tailored nutrition education intervention on self-reported fruit , vegetable , high-energy snack , and saturated fat intake compared to generic nutrition information in the total sample and among participants who did not comply with dietary guidelines ( the risk groups ) .
METHODS	A randomized controlled trial was conducted with a basic ( tailored intervention targeting individual cognition and self-regulation processes ; n = 456 ) , plus ( basic intervention additionally targeting environmental-level factors ; n = 459 ) , and control ( generic nutrition information ; n = 434 ) group .
METHODS	Participants were recruited from the general population and randomly assigned to a study group .
METHODS	Self-reported fruit , vegetable , high-energy snack , and saturated fat intake were assessed at baseline and at 1 - ( T1 ) and 4-months ( T2 ) postintervention using online questionnaires .
METHODS	Linear mixed model analyses examined group differences in change over time .
METHODS	Educational differences were examined with grouptimeeducation interaction terms .
RESULTS	In the total sample , the basic ( T1 : ES = -0.30 ; T2 : ES = -0.18 ) and plus intervention groups ( T1 : ES = -0.29 ; T2 : ES = -0.27 ) had larger decreases in high-energy snack intake than the control group .
RESULTS	The basic version resulted in a larger decrease in saturated fat intake than the control intervention ( T1 : ES = -0.19 ; T2 : ES = -0.17 ) .
RESULTS	In the risk groups , the basic version caused larger decreases in fat ( T1 : ES = -0.28 ; T2 : ES = -0.28 ) and high-energy snack intake ( T1 : ES = -0.34 ; T2 : ES = -0.20 ) than the control intervention .
RESULTS	The plus version resulted in a larger increase in fruit ( T1 : ES = 0.25 ; T2 : ES = 0.37 ) and a larger decrease in high-energy snack intake ( T1 : ES = -0.38 ; T2 : ES = -0.32 ) than the control intervention .
RESULTS	For high-energy snack intake , educational differences were found .
RESULTS	Stratified analyses showed that the plus version was most effective for high-educated participants .
CONCLUSIONS	Both intervention versions were more effective in improving some of the self-reported dietary behaviors than generic nutrition information , especially in the risk groups , among both higher - and lower-educated participants .
CONCLUSIONS	For fruit intake , only the plus version was more effective than providing generic nutrition information .
CONCLUSIONS	Although feasible , incorporating environmental-level information is time-consuming .
CONCLUSIONS	Therefore , the basic version may be more feasible for further implementation , although inclusion of feedback on the arrangement of the home food environment and on availability and prices may be considered for fruit and , for high-educated people , for high-energy snack intake .
BACKGROUND	Netherlands Trial Registry NTR3396 ; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3396 ( Archived by WebCite at http://www.webcitation.org/6VNZbdL6w ) .

###25896457
OBJECTIVE	To compare monocular and binocular mesopic contrast sensitivity and through focus following monocular implantation with KAMRA small-aperture inlay ( AcuFocus , Irvine , California , USA ) vs binocular implantation with an accommodating or multifocal intraocular lens ( IOL ) implant .
METHODS	Three-treatment randomized clinical trial of presbyopia-correcting IOLs with comparison to results from a previous nonrandomized multicenter clinical trial on the KAMRA corneal inlay .
METHODS	Study population of 507 subjects with KAMRA inlays ; predetermined subgroups included 327 subjects that underwent contrast sensitivity testing and another 114 subjects for defocus curve testing , along with 78 subjects randomized between bilateral Crystalens Advanced Optics ( AO ) ( Bausch + Lomb Surgical , Aliso Viejo , California , USA ) , AcrySof IQ ReSTOR +3.0 D ( Alcon Laboratories , Fort Worth , Texas , USA ) , or Tecnis +4 D Multifocal ( MF ) ( Abbott Medical Optics , Santa Ana , California , USA ) IOL .
RESULTS	KAMRA inlay subjects demonstrated improved intermediate and near vision with minimal to no change to distance vision , better contrast sensitivity in the inlay eye when compared to the multifocals , and better binocular contrast sensitivity when compared to all 3 intraocular lenses .
RESULTS	Crystalens AO was superior in uncorrected intermediate vision compared to the KAMRA inlay , but not in distance-corrected intermediate , and was worse in near vision .
RESULTS	The multifocals were superior in near vision at their respective optimum near focus points , but worse in intermediate vision compared to both KAMRA inlay and Crystalens AO .
CONCLUSIONS	The demonstrated performance of these devices should be considered , along with subjects ' visual demands and expectations , degree of crystalline lens dysfunction , and other ocular characteristics , in guiding the selection of small-aperture corneal inlay or specific intraocular lens in the correction of presbyopia .

###24314586
OBJECTIVE	To compare the effect of two lipid emulsions on the development of retinopathy of prematurity in very low birth weight infants .
METHODS	Randomized controlled study .
METHODS	Eighty very low birth weight infants receiving parenteral nutrition from the first day of life were evaluated .
METHODS	One of the two lipid emulsions were used in the study infants : Group 1 ( n = 40 ) received fish-oil based lipid emulsion ( SmofLipid ) and Group 2 ( n = 40 ) soybean oil based lipid emulsion ( Intralipid ) .
METHODS	The development of retinopathy of prematurity and the need for laser photocoagulation were assessed .
RESULTS	The maternal and perinatal characteristics were similar in both groups .
RESULTS	The median ( range ) duration of parenteral nutrition [ 14days ( 10-28 ) vs 14 ( 10-21 ) ] and hospitalization [ 34days ( 20-64 ) vs 34 ( 21-53 ) ] did not differ between the groups .
RESULTS	Laboratory data including complete blood count , triglyceride level , liver and kidney function tests recorded before and after parenteral nutrition also did not differ between the two groups .
RESULTS	In Group 1 , two patients ( 5.0 % ) and in Group 2 , 13 patients ( 32.5 % ) were diagnosed with retinopathy of prematurity ( OR : 9.1 , 95 % CI 1.9-43 .8 , p = 0.004 ) .
RESULTS	One patient in each group needed laser photocoagulation , without significant difference .
RESULTS	Multivariate analysis showed that only receiving fish-oil emulsion in parenteral nutrition decreased the risk of development of retinopathy of prematurity [ OR : 0.76 , 95 % CI ( 0.06-0 .911 ) , p = 0.04 ] .
CONCLUSIONS	Premature infants with very low birth weight receiving an intravenous fat emulsion containing fish oil developed less retinopathy of prematurity .

###25283697
OBJECTIVE	Cannabis-dependent participants with depressive disorder are less likely to achieve abstinence with venlafaxine-XR ( VEN-XR ) treatment .
OBJECTIVE	Individuals on VEN-XR reported more severe withdrawal , despite not reducing their smoking behavior .
OBJECTIVE	We hypothesized that withdrawal-like symptoms , likely medication side effects , led to continued marijuana smoking in this group .
METHODS	We conducted a secondary analysis using Marijuana Withdrawal Checklist ( MWC ) scores and urine THC to test whether severity of withdrawal-like symptoms mediates the relationship between VEN-XR treatment and continued marijuana smoking .
METHODS	We included 103 participants ( VEN-XR = 51 , Placebo = 52 ) .
METHODS	Marijuana use was dichotomized into smoking ( THC > 100 ng/ml ) and non-smoking ( THC 100 ng/ml ) weeks .
METHODS	MWC scores were obtained weekly .
METHODS	We used three models in a regression based mediation analysis .
RESULTS	The estimated risk of smoking marijuana was greater for individuals on VEN-XR in weeks 7-9 , even when controlling for MWC scores ( week 7 Risk Difference ( RD ) = 0.11 , p = 0.034 ; week 8 RD = 0.20 , p = 0.014 ) , and higher scores mediated this effect .
RESULTS	In weeks 10 and 11 , the estimated effect was stronger ( week 10 RD = 0.03 , p = 0.380 ; week 11 RD = 0.07 , p = 0.504 ) , and worse withdrawal-like symptoms more fully accounted for continued marijuana smoking in the VEN-XR group , according to the models .
CONCLUSIONS	Individuals treated with VEN-XR had more severe withdrawal-like symptoms , which mediated their continued marijuana smoking .
CONCLUSIONS	Noradrenergic agents , such as VEN-XR , may negatively impact treatment outcomes in cannabis-dependent patients attempting to reduce or stop their use .

###25170938
BACKGROUND	NRTI-sparing regimens may avoid long-term mitochondrial , bone and renal toxicities and maintain viral suppression .
METHODS	In the RADAR study , 85 antiretroviral-nave HIV-infected patients were randomized to receive either raltegravir ( RAL ) ( n = 42 ) or tenofovir/emtricitabine ( TDF/FTC ) ( n = 43 ) , each with ritonavir-boosted darunavir ( DRV/r ) .
METHODS	Virologic efficacy was assessed at weeks 24 and 48 .
METHODS	Bone mineral density ( BMD ) was assessed by dual energy X-ray absorptiometry ( DXA ) scan at baseline and week 48 , and bone turnover markers ( BTM ) assessed at weeks 0 , 16 and 48 .
RESULTS	Using an intention-to-treat analysis , 62.5 % of RAL subjects and 83.7 % of TDF/FTC subjects were responders ( VL < 48 copies/mL ) at week 48 ( p = 0.045 ; chi-square test ) .
RESULTS	The proportions of patients achieving VL < 200 copies/mL were similar : 72.5 % and 86.0 % ( p = 0.175 ) .
RESULTS	Premature treatment discontinuation was the main cause for failure .
RESULTS	No treatment-emergent resistance was observed .
RESULTS	Changes from baseline in RAL vs. TDF/FTC for CD4 + ( +199 vs. +216 cells/L , p = 0.63 ) , total cholesterol/HDL ( -0.25 vs. -0.71 mg/dL ( p = 0.270 ) , and eGFR ( -4.4 vs. -7.9 ml/min , p = 0.44 ) were comparable between groups .
RESULTS	Changes in subtotal BMD to week 48 were : +9.2 with RAL vs. -7 g/cm2 with TDF/FTC ( p = 0.002 ) .
RESULTS	Mean CTX changes were +0.04 vs. +0.24 ng/mL ( p = 0.001 ) , and mean P1NP changes were +3.59 vs. +30.09 ng/mL ( p = 0.023 ) .
RESULTS	BTM changes at week 16 predicted change in BMD by week 48 ( R = -0.394 , p = 0.003 for CTX ; and R = -0.477 , p < 0.001 for P1NP ) .
CONCLUSIONS	The NRTI-sparing regimen RAL+DRV / r did not achieve similar week 48 virologic efficacy compared with TDF/FTC + DRV/r , but was better with regard to markers of bone health .
BACKGROUND	ClinicalTrials.gov NCT 00677300 .

###24503140
OBJECTIVE	Many clinical trials have shown that 3-hydroxy-3-methylglutaryl-coenzyme A ( HMG-CoA ) reductase inhibitors ( statins ) can significantly reduce coronary artery disease in both primary and secondary prevention .
OBJECTIVE	A recent study showed that aggressive lipid-lowering therapy with strong statins could achieve coronary artery plaque regression , as evaluated with gray-scale intravascular ultrasound ( IVUS ) .
OBJECTIVE	However , it is unknown whether coronary plaque regression and stabilization are reinforced when eicosapentaenoic acid ( EPA ) is used with a strong statin .
METHODS	We aim to assess patients with stable angina or acute coronary syndrome who had undergone successful percutaneous coronary intervention ( PCI ) with integrated backscatter IVUS ( IB-IVUS ) guidance .
METHODS	They will be randomly allocated to receive pitavastatin ( 4mg ) , or pitavastatin ( 4mg ) plus EPA ( 1800mg ) , and prospectively followed for 6-8 months .
RESULTS	The primary endpoint will be changes in tissue characteristics in coronary plaques , evaluated by IB-IVUS , and secondary endpoints will include absolute changes in coronary plaque volume , serum lipid levels , and inflammatory markers .
RESULTS	The safety profile will also be evaluated .
CONCLUSIONS	The combination therapy of EPA and pitavastatin for regression of coronary plaque evaluated by IB-IVUS ( CHERRY ) study will be the first multicenter study using IB-IVUS to investigate the effects of combination therapy with pitavastatin and EPA on coronary plaque volume and tissue characteristics .

###25055754
BACKGROUND	The choice between unipolar and bipolar hemiarthroplasty for treatment of displaced intracapsular femoral neck fractures in elderly patients still remains controversial .
BACKGROUND	Our objective was to compare series of elderly individuals with a displaced femoral neck fracture treated with either a cemented , modular unipolar or bipolar prosthesis with the same femoral component .
METHODS	A prospective , randomized controlled trial of 175 displaced intracapsular femoral neck fractures in patients over 65 years was randomly allocated to unipolar ( 88 ) and to bipolar ( 87 ) hemiarthroplasty group .
METHODS	The primary end point was implant survival .
METHODS	Secondary end points included difference in ambulatory ability and mortality .
METHODS	Follow-up evaluations were performed at 2 months , at 1 , 3 and 5 years .
METHODS	Implant and patient survival were followed until 2/2012 .
METHODS	Survival analyses were performed using Kaplan-Meier curves with log-rank test .
METHODS	Data were analyzed using Chi-square test and Student 's t test .
RESULTS	Unipolar hemiarthroplasty group had a significantly higher dislocation rate when compared with bipolar hemiarthroplasty group .
RESULTS	This did not translate into difference in revision rates at 8 years .
RESULTS	Prosthetic survival ship was 0.98 ( 95 % Cl 0.94-1 .00 ) in the unipolar group and 0.97 ( 95 % Cl 0.93-1 .00 ) in the bipolar group .
RESULTS	There were no statistically significant differences in ambulatory ability , possibility to return home mortality or early radiological acetabular erosion .
RESULTS	There were significantly more one-time dislocations in the unipolar group , but there was no difference in incidence of revisions due to recurrent dislocations .
RESULTS	The overall mortality rate was 6 % at 30 days , 9 % at 90 days , 16 % at 12 months , and 53 % at 5 years .
RESULTS	There was no difference in mortality between the groups .
CONCLUSIONS	Unipolar hemiarthroplasty group had a significantly higher dislocation rate when compared with bipolar hemiarthroplasty group .
CONCLUSIONS	However , both provide elderly patients with equal ambulatory ability and low revision rate at medium-term follow-up .

###25653254
OBJECTIVE	To evaluate if nebulized 4 % lidocaine alone provides adequate laryngopharyngeal anesthesia for office-based diagnostic transnasal tracheoscopy ( TNT ) .
METHODS	A retrospective chart review ( January 2011 to June 2014 ) and a prospective case series ( July 2014 to December 2014 ) of patients who underwent diagnostic TNT were performed at a university voice and swallowing center .
METHODS	TNT cases were categorized by method of topical laryngopharyngeal anesthesia : nebulized 4 % lidocaine and 4 % lidocaine drip ( phase I ) and nebulized 4 % lidocaine only ( phase II ) .
RESULTS	TNT was performed a total of 59 times on 38 patients .
RESULTS	Eleven ( 69 % ) of 16 phase I TNT procedures involved significant patient discomfort and severe cough following the lidocaine drip .
RESULTS	Forty-two ( 98 % ) of 43 phase II TNT procedures were completed comfortably ; 1 case required additional anesthesia by lidocaine drip .
RESULTS	Retrospectively , 100 % ( n = 8 ) of patients who underwent both phase I and phase II TNTs were noted to prefer anesthesia with nebulizer alone .
RESULTS	In a prospective case series of 14 phase II TNT cases , 6 ( 86 % ) of 7 patients who previously underwent phase I TNT reported preference for anesthesia with nebulizer alone .
CONCLUSIONS	Nebulized lidocaine appears to provide sufficient laryngopharyngeal anesthesia for diagnostic TNT .
CONCLUSIONS	It is preferred by patients over laryngeal drip .

###24867633
OBJECTIVE	Investigate the 5-year longitudinal changes in bone curvature after acute anterior cruciate ligament ( ACL ) injury , and identify predictors of such changes .
METHODS	In the KANON-trial ( ISRCTN 84752559 ) , 111/121 young active adults with an acute ACL tear to a previously un-injured knee had serial 1.5 T MR images from baseline ( within 5 weeks from injury ) to 5 years after injury .
METHODS	Of these , 86 had ACL reconstruction ( ACLR ) performed early or delayed , 25 were treated with rehabilitation alone .
METHODS	Measures of articulating bone curvature were obtained from computer-assisted segmentation of MR images .
METHODS	Curvature ( mm ( -1 ) ) was determined for femur , tibia , medial/lateral femur , trochlea , medial/lateral tibia .
METHODS	Age , sex , treatment , BMI , meniscal injury , osteochondral fracture on baseline MR images were tested for association .
RESULTS	Over 5 years , curvature decreased in each region ( P < 0.001 ) suggesting flattening of convex shapes and increased concavity of concave shapes .
RESULTS	A higher BMI was associated with flattening of the femur ( P = 0.03 ) , trochlea ( P = 0.007 ) and increasing concavity of the lateral tibia ( LT ) ( P = 0.011 ) .
RESULTS	ACLR , compared to rehabilitation alone , was associated with flatter curvature in the femur ( P < 0.001 ) , medial femoral condyle ( P = 0.006 ) and trochlea ( P = 0.003 ) .
RESULTS	Any meniscal injury at baseline was associated with a more flattened curvature in the femur ( P = 0.038 ) , trochlea ( P = 0.039 ) , lateral femoral condyle ( P = 0.034 ) and increasing concavity of the LT ( P = 0.048 ) .
CONCLUSIONS	ACL injury is associated with significant changes in articulating bone curvature over a 5 year period .
CONCLUSIONS	Higher BMI , baseline meniscal injury and undergoing ACL reconstruction ( as distinct from undergoing rehabilitation alone ) are all associated with flattening of the articulating bone .

###25654524
OBJECTIVE	To test the effects of integrating health protection and health promotion with a continuous improvement system ( Kaizen ) on proximal employee outcomes ( health promotion , integration , and Kaizen ) and distal outcomes ( workability , productivity , self-rated health and self-rated sickness absence ) .
METHODS	Twelve units in a county hospital in Sweden were randomized to control or intervention groups using a quasiexperimental study design .
METHODS	All staff ( approximately 500 ) provided self-ratings in questionnaires at baseline , and a 12 - and 24-month follow-up ( response rate , 79 % to 87.5 % ) .
RESULTS	There was a significant increase in the proximal outcomes over time in the intervention group compared with the control group , and a trend toward improvement in the distal outcomes workability and productivity .
CONCLUSIONS	Integration seems to promote staff engagement in health protection and promotion , as well as to improve their understanding of the link between work and health .

###25125053
BACKGROUND	Laparoscopy cholecystectomy for the surgical treatment of cholelithiasis has been considered the gold standard .
BACKGROUND	The referred pain to the shoulder ( omalgia ) may be present to 63 % of the patients and limits outpatient management .
OBJECTIVE	The study was to evaluate the usefulness of acetazolamide associated with ketorolac for reduction of the omalgia to minimally invasive treatment .
METHODS	We performed a clinical trial , randomized , double blind in patients undergoing laparoscopic cholecystectomy to assess the reduction of post-operative omalgia comparing ketorolac and ketorolaco + acetazolamida .
METHODS	31 patients in each group were studied .
METHODS	The study group : 250 mg of acetazolamide before anesthetic induction and 30 mg of ketorolac in the immediate postoperative period .
METHODS	one tablet of placebo prior to the anesthetic induction and 30 mg of ketorolac in the immediate postoperative .
METHODS	The presence of omalgia was assessed using the analog visual scale .
METHODS	The variables recorded included : age , sex , flow of carbon dioxide intra-abdominal pressure , surgical time , urgent or elective surgery , omalgia , severity of pain evaluated by analog visual scale , addition analgesia .
RESULTS	Both groups were homogeneous and statistical analysis showed no differences in the variables studied .
RESULTS	The omalgia in the study group was presented at 9.67 % and in the group control was the 58.06 % ( p < 0.001 ) .
CONCLUSIONS	250 mg oral acetazolamide associated 30 mg of ketorolac reduces significantly the development of omalgia in patients undergoing laparoscopic cholecystectomy .

###25200415
BACKGROUND	Using a monoclonal antibody with greater affinity for IgE than omalizumab , we examined whether more complete suppression of IgE provided greater pharmacodynamic effects , including suppression of skin prick responses to allergen .
OBJECTIVE	To explore the pharmacokinetics , pharmacodynamics and safety of QGE031 ( ligelizumab ) , a novel high-affinity humanized monoclonal IgG1 anti-IgE .
METHODS	Preclinical assessments and two randomized , placebo-controlled , double-blind clinical trials were conducted in atopic subjects .
METHODS	The first trial administered single doses of QGE031 ( 0.1-10mg / kg ) or placebo intravenously , while the second trial administered two to four doses of QGE031 ( 0.2 - 4mg/kg ) or placebo subcutaneously at 2-week intervals .
METHODS	Both trials included an open-label omalizumab arm .
RESULTS	Sixty of 73 ( 82 % ) and 96 of 110 ( 87 % ) subjects completed the intravenous and subcutaneous studies , respectively .
RESULTS	Exposure to QGE031 and its half-life depended on the QGE031 dose and serum IgE level .
RESULTS	QGE031 had a biexponential pharmacokinetic profile after intravenous administration and a terminal half-life of approximately 20days .
RESULTS	QGE031 demonstrated dose - and time-dependent suppression of free IgE , basophil FcRI and basophil surface IgE superior in extent ( free IgE and surface IgE ) and duration to omalizumab .
RESULTS	At Day 85 , 6weeks after the last dose , skin prick wheal responses to allergen were suppressed by > 95 % and 41 % in subjects treated subcutaneously with QGE031 ( 2mg/kg ) or omalizumab , respectively ( P < 0.001 ) .
RESULTS	Urticaria was observed in QGE031 - and placebo-treated subjects and was accompanied by systemic symptoms in one subject treated with 10mg/kg intravenous QGE031 .
RESULTS	There were no serious adverse events .
CONCLUSIONS	These first clinical data for QGE031 , a high-affinity IgG1 anti-IgE , demonstrate that increased suppression of free IgE compared with omalizumab translated to superior pharmacodynamic effects in atopic subjects , including those with high IgE levels .
CONCLUSIONS	QGE031 may therefore benefit patients unable to receive , or suboptimally treated with , omalizumab .

###24578164
OBJECTIVE	Hospitalization for worsening heart failure ( HF ) is known to increase mortality and morbidity risk and has been frequently used as an endpoint in randomized clinical trials .
OBJECTIVE	Whether outpatient management of HF exacerbation carries similar prognostic and therapeutic information is less well known , but could be important for the design of trials that use HF hospitalization as an endpoint .
RESULTS	MADIT-CRT randomized patients with mild HF symptoms to resynchronization therapy vs. control with an average follow-up of 3.3 years and a total of 191 deaths .
RESULTS	HF events were centrally adjudicated for receiving i.v. decongestive therapy in an outpatient setting , or an augmented HF regimen during a hospital stay .
RESULTS	Patients were compared according to whether their first HF was an out - or inpatient event .
RESULTS	The first primary event was non-fatal outpatient HF , non-fatal inpatient HF , and death in 52 , 331 , and 78 patients , respectively .
RESULTS	Patients with inpatient HF tended to be older and more likely to have HF of ischaemic aetiology than subjects who developed outpatient HF events .
RESULTS	The risk of death following either type of non-fatal HF events was extremely high [ hazard ratio ( HR ) 12.4 , 95 % confidence interval ( CI ) 9.1-16 .9 for inpatient HF ; HR 10.7 , 95 % CI 6.1-18 .7 for outpatient HF ] compared with subjects without non-fatal HF events .
RESULTS	Allocation to CRT-D was associated with significant reduction in both types of HF .
CONCLUSIONS	Outpatient management of worsening HF portends a high risk of death , similar to inpatient HF events , and may be equally sensitive to the effects of therapy .
CONCLUSIONS	These findings suggest that outpatient HF events should be considered in publicly reported outcomes measures and future HF clinical trials .
BACKGROUND	NCT01294449 .

###26198966
OBJECTIVE	To observe the effects of anesthetic intervention with small-dose lidocaine and ketamine on early postoperative cognitive function in elderly patients undergoing surgeries for gastrointestinal tumors .
METHODS	Sixty patients ( ASA I-III , aged 63-82 years ) scheduled for surgeries for gastrointestinal tumors were randomized into intervention group ( n = 30 ) and control group ( n = 30 ) .
METHODS	After intravenous induction and tracheal intubation , the patients in the interventional group received intravenous infusion of 0.5 mg/kg lidocaine and 0.5 mg/kg ketamine , followed by continuous infusion of lidocaine at the rate of 0.5 mgkg ( -1 ) h ( -1 ) till the end of the operation ; the patients in the control group received saline infusion only .
METHODS	The cognitive function of the patients was assessed at 3 day before and 2 day after the operation using comprehensive neuro-psychological tests .
METHODS	Peripheral venous blood was extracted before anesthesia induction ( T0 ) , at the end of the surgery ( T1 ) , and at 1 day ( T2 ) and 2 days ( T3 ) after the operation for measurement of serum S-100 protein , NSE and IL-6 levels using ELISA .
RESULTS	The difference between the test scores before and after the operation ( X values ) was significantly smaller in the intervention group than in the control group ( P < 0.05 ) .
RESULTS	The intervention group showed a significantly lower incidence rate of postoperative cognitive dysfunction ( POCD ) than the control group ( 6.7 % vs 33.3 % , P < 0.05 ) .
RESULTS	Compared with the control group , the intervention group exhibited significantly lower serum levels of S-100 protein , NSE and IL-6 at T1 ( P < 0.05 ) , significantly lower NSE and IL-6 levels at T2 ( P < 0.05 ) time point , and significantly lower IL-6 level at T3 ( P < 0.05 ) .
CONCLUSIONS	Intravenous injection of small-dose lidocaine and ketamine during the operation can reduce the incidence of POCD in elderly patients undergoing surgeries for gastrointestinal tumors possibly in relation to decreased serum S-100 , NSE and IL-6 levels .

###24433926
OBJECTIVE	The impact of interferon beta ( IFN ) therapy on a patient 's quality of life ( QoL ) has not been completely clarified .
OBJECTIVE	This multicenter , independent , observational and longitudinal study was aimed to evaluate the impact of different pharmaceutical formulations of IFN-1a on QoL in patients affected by relapsing-remitting multiple sclerosis ( RRMS ) .
METHODS	The multiple sclerosis quality of life-54 questionnaire was used to assess patients ' QoL .
RESULTS	394 ( 66 % ) patients completed the two-year study ; 152 were treated with IFN-1a i.m. weekly injected ( group a ) , 152 with IFN-1a 44 g s.c. injected three times a week ( group b ) and 90 were untreated ( group c ) .
RESULTS	After two years , a significant increase was found in the physical health composite score ( = +3.1 in group a , = +3 in group b , p < 0.05 in both ) , mental health composite score ( = +4.7 in group a , = +5.5 in group b , p < 0.001 in both ) , in eight MSQoL sub-items of group a and in seven sub-items in group b. Conversely , the untreated group showed a slight decrease in seven domains .
RESULTS	The variable `` therapy with DMDs '' was associated with improved QoL .
CONCLUSIONS	QoL of RRMS could be improved by IFN-1a treatment , despite natural history data which seem to demonstrate that QoL could get worse over the time .

###24330706
BACKGROUND	Physical activity is believed to exert a beneficial effect on functional and cognitive rehabilitation of patients with stroke .
BACKGROUND	Although studies have addressed the impact of physical exercise in cerebrovascular prevention and rehabilitation , the underlying mechanisms leading to improvement are poorly understood .
BACKGROUND	Training-induced increase of cerebral perfusion is a possible mediating mechanism .
BACKGROUND	Our exploratory study aims to investigate training-induced changes in blood biomarker levels and magnetic resonance imaging in patients with subacute ischemic stroke .
METHODS	This biomarker-driven study uses an observational design to examine a subgroup of patients in the randomized , controlled PHYS-STROKE trial .
METHODS	In PHYS-STROKE , 215 patients with subacute stroke ( hemorrhagic and ischemic ) receive either 4weeks of physical training ( aerobic training , 5 times a week , for 50minutes ) or 4weeks of relaxation sessions ( 5 times a week , for 50minutes ) .
METHODS	A convenience sample of 100 of these patients with ischemic stroke will be included in BAPTISe and will receive magnetic resonance imaging ( MRI ) scans and an additional blood draw before and after the PHYS-STROKE intervention .
METHODS	Imaging scans will address parameters of cerebral perfusion , vessel size imaging , and microvessel density ( the Q factor ) to estimate the degree of neovascularization in the brain .
METHODS	Blood tests will determine several parameters of immunity , inflammation , endothelial function , and lipometabolism .
METHODS	Primary objective of this study is to evaluate differential changes in MRI and blood-derived biomarkers between groups .
METHODS	Other endpoints are next cerebrovascular events and functional status of the patient after the intervention and after 3months assessed by functional scores , in particular walking speed and Barthel index ( co-primary endpoints of PHYS-STROKE ) .
METHODS	Additionally , we will assess the association between functional outcomes and biomarkers including imaging results .
METHODS	For all endpoints we will compare changes between patients who received physical fitness training and patients who had relaxation sessions .
CONCLUSIONS	This exploratory study will be the first to investigate the effects of physical fitness training in patients with ischemic stroke on MRI-based cerebral perfusion , pertinent blood biomarker levels , and functional outcome .
CONCLUSIONS	The study may have an impact on current patient rehabilitation strategies and reveal important information about the roles of MRI and blood-derived biomarkers in ischemic stroke .
BACKGROUND	NCT01954797 .

###24819566
BACKGROUND	We previously reported decreased transfusions and donor exposures in preterm infants randomized to Darbepoetin ( Darbe ) or erythropoietin ( Epo ) compared with placebo .
BACKGROUND	As these erythropoiesis-stimulating agents ( ESAs ) have shown promise as neuroprotective agents , we hypothesized improved neurodevelopmental outcomes at 18 to 22 months among infants randomized to receive ESAs .
METHODS	We performed a randomized , masked , multicenter study comparing Darbe ( 10 g/kg , 1/week subcutaneously ) , Epo ( 400 U/kg , 3/week subcutaneously ) , and placebo ( sham dosing 3/week ) given through 35 weeks ' postconceptual age , with transfusions administered according to a standardized protocol .
METHODS	Surviving infants were evaluated at 18 to 22 months ' corrected age using the Bayley Scales of Infant Development III .
METHODS	The primary outcome was composite cognitive score .
METHODS	Assessments of object permanence , anthropometrics , cerebral palsy , vision , and hearing were performed .
RESULTS	Of the original 102 infants ( 946 196 g , 27.7 1.8 weeks ' gestation ) , 80 ( 29 Epo , 27 Darbe , 24 placebo ) returned for follow-up .
RESULTS	The 3 groups were comparable for age at testing , birth weight , and gestational age .
RESULTS	After adjustment for gender , analysis of covariance revealed significantly higher cognitive scores among Darbe ( 96.2 7.3 ; mean SD ) and Epo recipients ( 97.9 14.3 ) compared with placebo recipients ( 88.7 13.5 ; P = .01 vs ESA recipients ) as was object permanence ( P = .05 ) .
RESULTS	No ESA recipients had cerebral palsy , compared with 5 in the placebo group ( P < .001 ) .
RESULTS	No differences among groups were found in visual or hearing impairment .
CONCLUSIONS	Infants randomized to receive ESAs had better cognitive outcomes , compared with placebo recipients , at 18 to 22 months .
CONCLUSIONS	Darbe and Epo may prove beneficial in improving long-term cognitive outcomes of preterm infants .

###25128211
BACKGROUND	Current academic literature suggests that school gardening programmes can provide an interactive environment with the potential to change children 's fruit and vegetable intake .
BACKGROUND	This is the first cluster randomised controlled trial ( RCT ) designed to evaluate whether a school gardening programme can have an effect on children 's fruit and vegetable intake .
METHODS	The trial included children from 23 schools ; these schools were randomised into two groups , one to receive the Royal Horticultural Society ( RHS ) - led intervention and the other to receive the less involved Teacher-led intervention .
METHODS	A 24-hour food diary ( CADET ) was used to collect baseline and follow-up dietary intake 18months apart .
METHODS	Questionnaires were also administered to evaluate the intervention implementation .
RESULTS	A total of 641 children completed the trial with a mean age of 8.1 years ( 95 % CI : 8.0 , 8.4 ) .
RESULTS	The unadjusted results from multilevel regression analysis revealed that for combined daily fruit and vegetable intake the Teacher-led group had a higher daily mean change of 8g ( 95 % CI : -19 , 36 ) compared to the RHS-led group -32 g ( 95 % CI : -60 , -3 ) .
RESULTS	However , after adjusting for possible confounders this difference was not significant ( intervention effect : -40 g , 95 % CI : -88 , 1 ; p = 0.06 ) .
RESULTS	The adjusted analysis of process measures identified that if schools improved their gardening score by 3 levels ( a measure of school gardening involvement - the scale has 6 levels from 0 ` no garden ' to 5 ` community involvement ' ) , irrespective of group allocation , children had , on average , a daily increase of 81g of fruit and vegetable intake ( 95 % CI : 0 , 163 ; p = 0.05 ) compared to schools that had no change in gardening score .
CONCLUSIONS	This study is the first cluster randomised controlled trial designed to evaluate a school gardening intervention .
CONCLUSIONS	The results have found very little evidence to support the claims that school gardening alone can improve children 's daily fruit and vegetable intake .
CONCLUSIONS	However , when a gardening intervention is implemented at a high level within the school it may improve children 's daily fruit and vegetable intake by a portion .
CONCLUSIONS	Improving children 's fruit and vegetable intake remains a challenging task .
BACKGROUND	ISRCTN11396528 .

###25877748
OBJECTIVE	Epidermal growth factor receptor tyrosine kinase inhibitors are effective as first-line therapy for advanced non-small cell lung cancer patients harboring epidermal growth factor receptor mutations .
OBJECTIVE	However , it is unknown whether second-line platinum-based chemotherapy after epidermal growth factor receptor tyrosine kinase inhibitor therapy could lead to better outcomes .
OBJECTIVE	We evaluated the efficacy of second-line platinum-based chemotherapy after gefitinib for advanced non-small cell lung cancers harboring epidermal growth factor receptor mutations ( the NEJ002 study ) .
METHODS	Seventy-one non-small cell lung cancers , treated with gefitinib as first-line therapy and then receiving platinum-based chemotherapy as second-line therapy were evaluated in NEJ002 .
METHODS	Patients were evaluated for antitumor response to second-line chemotherapy by computed tomography according to the criteria of the Response Evaluation Criteria in Solid Tumors group ( version 1.0 ) .
RESULTS	Of the 71 patients receiving platinum-based chemotherapy after first-line gefitinib , a partial response was documented in 25.4 % ( 18/71 ) , stable disease in 43.7 % ( 31/71 ) and progression of disease in 21.1 % ( 15/71 ) .
RESULTS	The objective response and disease control rates were 25.4 % ( 18/71 ) and 69 % ( 49/71 ) , respectively .
RESULTS	There was no significant difference between first - and second-line chemotherapy in objective response and disease control rates for advanced non-small cell lung cancer harboring activating epidermal growth factor receptor mutations .
RESULTS	In the analysis of epidermal growth factor receptor mutation types , the objective responses of deletions in exon 19 and a point mutation in exon 21 ( L858R ) were 27.3 % ( 9/33 ) and 28.1 % ( 9/32 ) , respectively , but these differences between objective response rates were not significant .
CONCLUSIONS	The efficacy of second-line platinum-based chemotherapy followed at progression by gefitinib was similar to first-line platinum-based chemotherapy , and epidermal growth factor receptor mutation types did not influence the efficacy of second-line platinum-based chemotherapy .

###24283806
OBJECTIVE	This study aims to compare histopathological results of conventional surgery and transoral radiofrequency ablation in patients with early stage laryngeal carcinoma .
METHODS	Between January 2006 and May 2010 , 36 patients ( 34 males , 2 females ; mean age 61.6 years ; range 43 to 77 years ) who underwent partial laryngectomy in our clinic were retrospectively analyzed .
METHODS	All patients were randomized to partial laryngectomy with radiofrequency ablation or conventional surgery .
METHODS	Hoarseness due to early stage T1 and selected T2N0 vocal cord lesions was an indication for surgery .
METHODS	Of 20 patients receiving conventional surgery , 14 underwent partial laryngectomy , while six patients underwent cordectomy for the excision of tumors .
METHODS	Tumors were excised by transoral radiofrequency ablation in 16 patients .
RESULTS	We observed thermal artifacts in four patients undergoing conventional surgery and in 13 patients undergoing transoral radiofrequency ablation .
RESULTS	There was also hemorrhage in 16 patients undergoing conventional surgery and in seven patients undergoing transoral radiofrequency ablation .
RESULTS	Histopathological examination revealed that the surgical margins were safe in 10 patients after radiofrequency ablation .
RESULTS	The specimens obtained from six patients showed thermal artifacts which complicated histopathological examination .
RESULTS	Sixteen ( 80 % ) of 20 conventional surgery patients and nine ( 56 % ) of 16 radiofrequency ablation patients had safe surgical margins .
CONCLUSIONS	In radiofrequency ablation , the surgical zone must be larger than in conventional surgery due to the high risk of tissue damage and complicated histopathological examination .

###24966150
BACKGROUND	Serum vascular endothelial growth factor-C ( VEGF-C ) , transforming growth factor - ( TGF - ) , and interleukin ( IL ) -6 promote angiogenesis and metastases in colon cancer .
BACKGROUND	We hypothesized that patients who received propofol-epidural anaesthesia ( PEA ) would exhibit decreases in VEGF-C , TGF - , and IL-6 and an increase in IL-10 compared with patients who received general anaesthesia ( GA ) .
METHODS	Colon cancer surgery patients were randomly assigned to the PEA ( n = 20 ) or GA ( n = 20 ) group .
METHODS	Serum VEGF-C , TGF - , IL-6 , and IL-10 levels before surgery and 24 h after surgery were measured .
RESULTS	Patients who received PEA showed decreases in VEGF-C [ 526 ( 261 ) vs 834 ( 304 ) pg ml ( -1 ) , P = 0.001 ] , TGF - ( P = 0.027 ) , and IL-6 ( P = 0.007 ) and an increase in IL-10 ( P = 0.001 ) 24 h after surgery compared with patients subjected to GA. .
RESULTS	The visual analogue scale scores at rest and during coughing at 2 and 24 h after operation were significantly lower in PEA patients ( P < 0.05 ) .
CONCLUSIONS	PEA reduces serum concentrations of factors associated with angiogenesis during colon cancer surgery .
BACKGROUND	ChiCTR-TRC-13003146 ( www.chictr.org ) .

###24806159
BACKGROUND	Cytomegalovirus ( CMV ) infection is a leading cause of illness and death in patients who have undergone allogeneic hematopoietic-cell transplantation .
BACKGROUND	Available treatments are restricted by clinically significant toxic effects and drug resistance .
METHODS	In this phase 2 study , we evaluated the effect of letermovir ( also known as AIC246 ) , a new anti-CMV drug with a novel mechanism of action , on the incidence and time to onset of prophylaxis failure in CMV-seropositive recipients of allogeneic hematopoietic-cell transplants from matched related or unrelated donors .
METHODS	From March 2010 through October 2011 , we randomly assigned 131 transplant recipients in a 3:1 ratio to three sequential study cohorts according to a double-blind design .
METHODS	Patients received oral letermovir ( at a dose of 60 , 120 , or 240 mg per day , or matching placebo ) for 12 weeks after engraftment .
METHODS	The primary end point was all-cause prophylaxis failure , defined as discontinuation of the study drug because of CMV antigen or DNA detection , end-organ disease , or any other cause .
METHODS	Patients underwent weekly surveillance for CMV infection .
RESULTS	The reduction in the incidence of all-cause prophylaxis failure was dose-dependent .
RESULTS	The incidence of prophylaxis failure with letermovir , as compared with placebo , was 48 % versus 64 % at a daily letermovir dose of 60 mg ( P = 0.32 ) , 32 % at a dose of 120 mg ( P = 0.01 ) , and 29 % at a dose of 240 mg ( P = 0.007 ) .
RESULTS	Kaplan-Meier time-to-onset profiles for prophylaxis failure showed a significant difference in the comparison of letermovir at a dose of 240 mg per day with placebo ( P = 0.002 ) .
RESULTS	The safety profile of letermovir was similar to placebo , with no indication of hematologic toxicity or nephrotoxicity .
CONCLUSIONS	Letermovir , as compared with placebo , was effective in reducing the incidence of CMV infection in recipients of allogeneic hematopoietic-cell transplants .
CONCLUSIONS	The highest dose ( 240 mg per day ) had the greatest anti-CMV activity , with an acceptable safety profile .
CONCLUSIONS	( Funded by AiCuris ; ClinicalTrials.gov number , NCT01063829 . )

###24266309
OBJECTIVE	Bleeding from peptic ulcers can be effectively and safely treated with endoscopic hemoclips therapy .
OBJECTIVE	However , due to certain limiting factors of hemoclips , application of combination with another endoscopic method may give better results .
OBJECTIVE	The aim of this study was to examine the efficacy and safety of endoscopic hemoclips therapy and to evaluate potential benefits of this therapy combined with epinephrine in the treatment of bleeding peptic ulcers .
METHODS	This prospective randomized study included 70 patients with bleeding gastric or duodenal ulcer .
METHODS	In 34 of the patients endoscopic hemoclips therapy was applied ( group I ) , and in 36 of them a combined therapy of hemoclips and epinephrine ( group II ) .
RESULTS	Initial hemostasis was achieved in most patients treated with endoscopic hemoclips therapy ( 94.1 % ) as well as in the patients treated with combination therapy ( 97.2 % ) .
RESULTS	After initial hemostasis achieved rebleeding occurred in 3 ( 9.3 % ) patients treated with hemoclips and in 2 ( 5.7 % ) patients treated with combination therapy , but this difference was not statistically significant ( p > 0.05 ) .
RESULTS	The difference in the achieved final hemostasis between the group I ( 91.1 % ) and the group II ( 94.4 % ) was not statistically significant .
RESULTS	Also , the differences between the two groups of patients in the need for blood transfusions , length of hospital stay , need for surgery and mortality were not statistically significant ( p > 0.05 ) .
CONCLUSIONS	Endoscopic hemoclips therapy is effective and safe in treatment of bleeding peptic ulcers .
CONCLUSIONS	Combination therapy of hemoclips and epinephrine has no advantage over hemoclips monotherapy .

###24607797
OBJECTIVE	To assess whether vaginal misoprostol or oral nonsteroidal anti-inflammatory drugs ( NSAIDs ) reduce pain during and 30 minutes after hysterosalpingography ( HSG ) .
METHODS	Randomized prospective , controlled , parallel-group study ( Canadian Task Force classification I ) .
METHODS	University teaching hospital .
METHODS	One hundred sixty-eight women with primary infertility who underwent HSG for evaluation of infertility .
METHODS	Patients were randomly assigned to 1 of 3 groups .
METHODS	Group 1 received 200 g misoprostol vaginally 6 hours before HSG ; group 2 , 50 mg diclofenac potassium orally 45 to 60 minutes before HSG ; and group 3 , no medication .
METHODS	The primary outcome of the study was to evaluate the severity of pain during and 30 minutes after the procedure using a visual analog scale ( VAS ) ranging from 1 ( very favorable ) to 10 ( very unfavorable ) .
METHODS	The secondary outcomes were to assess the rate of completion and the vasovagal effects including nausea , vomiting , sweating , weakness , syncope , hypotension , and bradycardia .
RESULTS	There was no statistically significant difference in the median ( 25 % -75 % ) VAS pain scores between women administered vaginal misoprostol ( median , 6.7 cm ; range , 4.7-9 cm ) and the control group ( median , 6.7 cm ; range , 4.6-8 .8 cm ) during the HSG .
RESULTS	However , women in the NSAID group ( median , 5.5 cm ; range , 3-7 .6 cm ) reported less pain than did those in the misoprostol group ( p = .009 ) and the control group ( p = .03 ) .
RESULTS	At 30 minutes after HSG , there was no significant difference in the median VAS pain scores between patients administered NSAIDs ( median , 2.3 cm ; range , 1.4-4 .2 ) or misoprostol ( median , 2.3 cm ; range , 1.2-4 .4 ) and the control group ( median , 2.2 cm ; range , 1.3-4 .4 ) .
CONCLUSIONS	There is no benefit in terms of pain reduction with the use of misoprostol during HSG or at 30 minutes after the procedure .
CONCLUSIONS	However , NSAIDs are associated with pain relief during the HSG procedure .

###25294611
BACKGROUND	Oral glucocorticoids can prevent acute mountain sickness ( AMS ) .
BACKGROUND	Whether inhaled budesonide ( BUD ) can prevent AMS remains unknown .
OBJECTIVE	Our aim was to investigate the effectiveness of BUD in AMS prevention .
METHODS	Eighty subjects were randomly assigned to receive budesonide ( BUD , inhaled ) , procaterol tablet ( PT ) , budesonide/formoterol ( BUD/FM , inhaled ) , or placebo tablet ( n = 20 in each group ) .
METHODS	Subjects were treated for 3 days before ascending from 500 m to 3700 m within 2.5 h by air .
METHODS	Lake Louis AMS questionnaire , blood pressure , heart rate , and oxygen saturation ( SpO2 ) were examined at 20 , 72 , and 120 h after high-altitude exposure .
METHODS	Pulmonary function was measured at 20 h after exposure .
RESULTS	Compared with placebo , BUD significantly reduced the incidence of AMS ( 70 % vs. 25 % at 20 h , p < 0.05 ; both 10 % vs. 5 % at 72 and 120 h , both p > 0.05 ) without side effects .
RESULTS	The relative risk was 0.357 , and the risk difference was 0.45 .
RESULTS	Mean SpO2 was higher in BUD , BUD/FM , and PT groups than in the placebo group at 20 h ( p < 0.05 ) .
RESULTS	SpO2 in all 80 subjects dropped after ascent ( 98.1 % to 88.12 % , p < 0.01 ) and increased gradually , but it was still lower at 120 h than at baseline ( 92.04 % vs. 98.1 % , p < 0.01 ) .
RESULTS	Pulmonary function did not differ among the four groups at 20 h.
CONCLUSIONS	BUD can prevent AMS without side effects .
CONCLUSIONS	The alleviation of AMS may be related to increased blood oxygen levels rather than pulmonary function .

###24330904
OBJECTIVE	The effects of supplementation of the omega-3 fatty acids eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) on prevalence and severity of depression were evaluated in patients after a myocardial infarction .
METHODS	A cross-sectional evaluation ( posttest-only design ) within the prospective , randomized , controlled , multicenter OMEGA trial was performed in patients after myocardial infarction at 12 months ' follow-up ( N = 2,081 ; age , mean = 64 years ; men , 76.7 % ; women , 21.8 % ) from April 2005 to June 2007 .
METHODS	Patients received supplementation with ethyl esters 90 ( 460-mg EPA and 380-mg DHA ) or placebo for 12 months .
METHODS	Depression was assessed with the Beck Depression Inventory-II ( BDI-II ) ; a BDI-II cutoff score of 14 was used as diagnosis of depression .
RESULTS	When the total population was evaluated , no effects of EPA/DHA supplementation on depressive symptoms according to BDI-II score ( mean [ SD ] ) could be demonstrated : EPA/DHA ( n = 1,046 ) , 7.1 ( 6.9 ) ; placebo ( n = 1,035 ) , 7.1 ( 7.0 ) ; P = .7 .
RESULTS	The post hoc analyses of depressed patients with and without antidepressants revealed a tendency toward an antidepressant effect in patients with EPA/DHA supplementation as monotherapy : EPA/DHA ( n = 125 ) , 19.4 ( 5.8 ) ; placebo ( n = 113 ) , 19.9 ( 5.1 ) ; P = .07 .
RESULTS	However , in depressed patients with EPA/DHA supplementation as adjunctive to conventional antidepressants , a clinically relevant antidepressant effect was demonstrated : EPA/DHA ( n = 33 ) , 20.9 ( 7.1 ) ; placebo ( n = 29 ) , 24.9 ( 8.5 ) ; P < .05 .
CONCLUSIONS	EPA/DHA supplementation in the total sample of patients after myocardial infarction had no effect on depressive symptoms .
CONCLUSIONS	The clinically relevant antidepressant effect in the subgroup of depressed patients with EPA/DHA supplementation as adjunctive to conventional antidepressants that was revealed in the post hoc analysis might provide a basis for a controlled , prospective trial of omega-3 augmentation of antidepressants in patients after myocardial infarction .
BACKGROUND	ClinicalTrials.gov identifier : NCT00251134 .

###24461162
OBJECTIVE	This paper seeks to determine the relevance and likely salience of cognitive behaviour therapy ( CBT ) as a treatment for melancholic depression .
METHODS	The findings of a randomised trial comparing 12-week outcome of 18 patients with melancholic depression receiving antidepressant medication and 11 receiving CBT were evaluated , and qualitative explanations for the outcomes were provided principally by the treating CBT practitioners .
RESULTS	In the trial , CBT showed no improvement in depression severity in the first four weeks and then some level of improvement over the subsequent eight weeks .
RESULTS	Outcome was superior for those receiving antidepressant medication at 12 weeks and was first demonstrated at four weeks .
RESULTS	The benefits of CBT appeared to be in settling anxiety , dealing with cognitive processing of having a melancholic depression and addressing any personality vulnerabilities .
CONCLUSIONS	While a pilot study , our qualitative reports indicate that CBT may provide a useful role in managing melancholia as an adjunct to antidepressant medication .
CONCLUSIONS	Future studies examining such a combination treatment model should seek to determine if indicative data provided here argue for a sequencing model of CBT being introduced after medication has addressed core biological underpinnings .

###25452071
BACKGROUND	This study identified distinct tobacco use trajectories across 18months in 943 veteran smokers with posttraumatic stress disorder ( PTSD ) in order to describe quit and relapse patterns , examine associations between trajectory groups on baseline characteristics and cessation service utilization , and explore group differences in mental health outcomes .
METHODS	Veterans who participated in a multisite , randomized trial of integrated smoking cessation care were grouped using k-means clustering based on reported daily tobacco use between baseline and 18months .
METHODS	Four trajectory clusters were identified : no reduction ( 62 % ) , temporary reduction ( 11 % ) , late sustained reduction ( 9 % ) and early sustained reduction ( 18 % ) .
RESULTS	Median quit times in the early , late , temporary , and no reduction groups were 451 , 141.5 , 97 , and 2days , respectively .
RESULTS	Compared to the early reduction group , the temporary reduction group exhibited higher baseline depression ( p < 0.01 ) and anxiety ( p < 0.01 ) , but did not differ in treatment received , with both groups attending significantly more cessation visits ( p < 0.001 ) and more likely to receive recommended pharmacotherapy ( p < 0.001 ) than the no reduction group between baseline and 6months .
RESULTS	The early reduction group exhibited lower depression relative to the no reduction ( p < 0.01 ) and temporary reduction ( p < 0.01 ) groups across all assessments between baseline and 18months .
RESULTS	Differences were not observed between groups in depressive or PTSD symptom change over time between baseline and 18months .
CONCLUSIONS	Tobacco use trajectories among treated smokers with PTSD vary distinctly .
CONCLUSIONS	Characteristics of identified subgroups may lead to targeted interventions among smokers with PTSD and potentially other psychiatric disorders .

###25106493
BACKGROUND	Uveal melanoma is the most common primary intraocular malignancy in adults .
BACKGROUND	Despite successful control of the primary tumor , metastatic disease will ultimately develop in approximately 50 % of patients , with the liver being the most common site for metastases .
BACKGROUND	The median survival for patients with liver metastases is between 6 and 12months , and no treatment has in randomized trials ever been shown to prolong survival .
BACKGROUND	A previous phase II trial using isolated hepatic perfusion ( IHP ) has suggested a 14-month increase in overall survival compared with a historic control group consisting of the longest surviving patients in Sweden during the same time period ( 26 versus 12months ) .
METHODS	This is the protocol for a multicenter phase III trial randomizing patients with isolated liver metastases of uveal melanoma to IHP or best alternative care ( BAC ) .
METHODS	Inclusion criteria include liver metastases ( verified by biopsy ) and no evidence of extra-hepatic tumor manifestations by positron emission tomography-computed tomography ( PET-CT ) .
METHODS	The primary endpoint is overall survival at 24months , with secondary endpoints including response rate , progression-free survival , and quality of life .
METHODS	The planned sample size is 78 patients throughout five years .
CONCLUSIONS	Patients with isolated liver metastases of uveal melanoma origin have a short expected survival and no standard treatment option exists .
CONCLUSIONS	This is the first randomized clinical trial to evaluate IHP as a treatment option with overall survival being the primary endpoint .
BACKGROUND	ClinicalTrials.gov registration number : NCT01785316 ( registered 1 February 2013 ) .
BACKGROUND	EudraCT registration number : 2013-000564-29 .

###25185212
OBJECTIVE	To compare the influence of low-frequency ( 10-25 Hz ) versus higher ( 60-80 Hz ) frequency stimulation of the pedunculopontine nucleus area ( PPNa ) on akinaesia , freezing of gait and daytime sleepiness .
METHODS	We included nine patients with Parkinson 's disease ( PD ) and severe gait disorders .
METHODS	In this double-blind randomised cross-over study , patients were assessed after 24 h of PPNa stimulation .
METHODS	Assessments included the motor part of the Unified Parkinson 's Disease Rating Scale , the Epworth Sleepiness Scale and a behavioural gait assessment .
RESULTS	Compared with 60-80 Hz , 10-25 Hz PPNa stimulation led to decreased akinaesia , gait difficulties and daytime sleepiness in 7/9 patients .
RESULTS	In one patient , these symptoms were aggravated under 10-25 Hz stimulation compared with 60-80 Hz .
CONCLUSIONS	These results are in keeping with the benefits of chronic PPNa stimulation for gait and postural difficulties in patients with PD , and with regard to the influence of patients ' clinical characteristics , differential neuronal loss in the PPNa and electrode location .
CONCLUSIONS	We conclude that in patients with PPNa stimulation , low frequency provides a better outcome than high-frequency stimulation .

###25007693
BACKGROUND	The present study is a prospective randomized double-blinded study that designed to evaluate and compare the effectiveness of postoperative pain control and incidence of complications between ilioinguinal/iliohypogastric nerve block and intravenous morphine in paediatric patients undergoing unilateral orchidopexy in day surgery unit .
METHODS	Seventy patients aged 2-12 years were randomly allocated to two groups of thirty five .
METHODS	One group received intravenous morphine 100 microgram/kg before skin incision and the other group had ilioinguinal/iliohypogastric nerve block with 0.25 ml/kg bupivacaine 0.5 % also before skin incision .
METHODS	All patients have received standardized anaesthesia .
METHODS	Postoperative pain was assessed using 0 - 10 scale at 0 , 1 , 2 , 3 and 4 postoperative hours , also the intraoperative fentanyl requirements , time to first postoperative analgesia , the total number of paracetamol doses and any extra analgesic requirements were recorded , side effects like respiratory depression , vomiting , itching , inguinal hematoma and lower limb weakness were assessed during the first 24 hours .
RESULTS	Pain scores were significantly lower in the morphine group compared to the block group on admission and one hour after admission to the postanaesthesia care unit , no significant difference in pain score on 2nd , 3rd and 4th postoperative hours .
RESULTS	The total number of intraoperative fentanyl doses was significantly higher in the block group compared to morphine group , there was no significant difference in the duration of analgesia , number of total paracetamol doses , need for extra analgesics in both groups over the 24 postoperative hours .
RESULTS	None of the seventy patients experienced postoperative respiratory depression , inguinal hematoma or lower limb weakness , but significantly more patients in morphine group experienced vomiting and itching compared to the block group .
CONCLUSIONS	Ilioinguinal/iliohypogastric nerve block and intravenous morphine administered following general anaesthesia for unilateral orchidopexy in day surgery unit are safe and effective in controlling postoperative pain , morphine analgesia had a higher incidence of postoperative vomiting and itching .

###24460545
BACKGROUND	Right heart evaluation on coronary computed tomography angiography ( CCTA ) is underutilized due to nonopacification of the right heart chambers and poor endocardial resolution .
BACKGROUND	We analyzed feasibility and reproducibility of right heart functional analysis by measuring CCTA-based tricuspid annular plane systolic excursion ( CT-TAPSE ) on ECG-gated CCTA and correlated the results with 2D transthoracic echocardiography ( TTE ) - derived TAPSE ( Echo-TAPSE ) .
METHODS	CT-TAPSE was measured on a total population of 41 patients who had CCTA and TTE performed within 6 months of each other .
METHODS	Two independent CCTA readers performed analysis on reformatted four-chamber view .
METHODS	Intra - and inter-observer variability analysis was performed on 16 randomly selected patients .
METHODS	Correlative ( Spearman 's R ) and Bland-Altman analysis was used to assess the level of agreement between the 2 methods and to compare CT-TAPSE with Echo-TAPSE .
RESULTS	CT-TAPSE measured by Readers 1 and 2 on 16 randomly selected patients , demonstrated excellent intra-observer and inter-observer agreement , with very close correlation ( R > 0.80 and 2-tailed P-value of < 0.001 ) .
RESULTS	When tested in the entire study population of 41 patients , CT-TAPSE correlated closely with Echo-TAPSE ( R = 0.738 , P < 0.001 ) .
RESULTS	Bland-Altman analysis indicated that the 2 methods provided similar measures as majority of values lay within the 95 % confidence limits .
RESULTS	Based on abnormal Echo-TAPSE cutoff value of < 16 mm , CT-TAPSE identified impaired right ventricle ( RV ) function with sensitivity of 82 % and specificity of 93 % , respectively .
CONCLUSIONS	We demonstrated feasibility and reproducibility of assessing TAPSE on coronary CTA .
CONCLUSIONS	RV functional analysis utilizing CT-TAPSE is simple and reproducible methodology , and is in close agreement with Echo-TAPSE .

###24758075
OBJECTIVE	To observe the therapeutic effect of Yangxue Tongluo Recipe ( YTR ) combined with immunosuppressive agents in the treatment of rheumatoid arthritis ( RA ) .
METHODS	Totally 88 RA patients were randomly assigned to the treatment group [ 47 cases , YTR combined Methotrexate ( MTX ) + Leflunomide ( LEF ) treatment ] and the control group ( 41 cases , MTX + LEF therapy ) .
METHODS	All patients received 12-week treatment .
METHODS	Clinical symptoms and signs , laboratory tests [ erythrocyte sedimentation rate ( ESR ) , rheumatoid factor ( RF ) , and C reactive protein ( CRP ) ] , and adverse reactions were observed before and after treatment .
RESULTS	The total effective rate was 91.5 % ( 43/47 cases ) in the treatment group , and the total effective rate was 75.6 % ( 31/41 cases ) in the control group .
RESULTS	There was statistical difference between the two groups ( P < 0.05 ) .
RESULTS	The morning stiffness , the rest pain , the number of tender joints , the number of swollen joints , tender joint index , swollen joint index , ESR , RF , and CRP were significantly improved in the two groups after treatment ( P < 0.01 ) .
RESULTS	Besides , clinical symptoms and signs , ESR , RF , and CRP were more improved in the treatment group after treatment , when compared with those in the control group ( P < 0.05 ) .
RESULTS	Gastrointestinal discomfort was the main adverse reaction in the two groups , but the occurrence was lower in the treatment group than in the control group ( P > 0.05 ) .
CONCLUSIONS	The clinical efficacy of YTR combined MTX + LEF in the treatment of RA was better than using Western medicine alone .
CONCLUSIONS	It was more safe with less adverse reactions .

###24866574
OBJECTIVE	Randomised studies have demonstrated a beneficial effect of pre-surgical treatment with somatostatin analogues ( SSA ) in acromegaly when evaluated early postoperatively .
OBJECTIVE	The objective of this study was to evaluate the long-term surgical cure rates .
METHODS	Newly diagnosed patients were randomised to direct surgery ( n = 30 ) or 6-month pretreatment with octreotide LAR ( n = 32 ) .
METHODS	The patients were evaluated 1 and 5 years postoperatively .
METHODS	Cure was defined as normal IGF1 levels and by normal IGF1 level combined with nadir GH < 2mU/l in an oral glucose tolerance test , all without additional post-operative treatment .
METHODS	A meta-analysis using the other published randomised study with long-term analyses on preoperative SSA treatment was performed .
RESULTS	The proportion of patients receiving post-operative acromegaly treatment was equal in the two groups .
RESULTS	When using the combined criteria for cure , 10/26 ( 38 % ) macroadenomas were cured in the pretreatment group compared with 6/25 ( 24 % ) in the direct surgery group 1 year postoperatively ( P = 0.27 ) , and 9/22 ( 41 % ) vs 6/22 ( 27 % ) macroadenomas , respectively , 5 years postoperatively ( P = 0.34 ) .
RESULTS	In the meta-analysis , 16/45 ( 36 % ) macroadenomas were cured using combined criteria in the pretreatment group vs 8/45 ( 18 % ) in the direct surgery group after 6-12 months ( P = 0.06 ) , and 15/41 ( 37 % ) vs 8/42 ( 19 % ) , respectively , in the long-term ( P = 0.08 ) .
CONCLUSIONS	This study does not prove a beneficial effect of SSA pre-surgical treatment , but in the meta-analysis a trend towards significance can be claimed .
CONCLUSIONS	A potential favourable , clinically relevant response can not be excluded .

###25523634
BACKGROUND	Patients with chronic severe asthma ( CSA ) have a crippling disease and current available treatments are not satisfactory .
BACKGROUND	Thus , management of CSA remains a major unmet need .
BACKGROUND	Although the evidence from existing randomized controlled trials fails to support a definite role for immunomodulatory drugs in these patients due to major methodologic drawbacks , findings with low-dose methotrexate ( MTX ) are encouraging .
BACKGROUND	However , larger and well-designed clinical trials are required to establish the beneficial role of MTX in CSA , and for the detection of the key characteristics of those who are going to respond to this drug .
METHODS	Patients will be recruited from the accessible asthmatic patients lists of tertiary referral centers .
METHODS	All patients will meet the stringent diagnostic criteria for CSA , including the requirement for the regular use of Global Initiative for Asthma ( GINA ) Global Strategy for Asthma Management and Prevention Step 5 medications ( oral prednisone and/or omalizumab ) .
METHODS	The experimental design of the proposed study will take the form of a double-blind parallel-randomized placebo-controlled trial consisting of a total of eight visits , including run-in and run-out periods .
METHODS	Patients will be randomly allocated to receive either MTX or a matched placebo once a week as an add-on therapy to their existing medication after run-in .
METHODS	Physiological , laboratory and clinical assessments will be measured regularly throughout the study and compared with baseline assessments .
CONCLUSIONS	We expect that MTX will reduce Step 5 medications dosage in patients with CSA without compromising the overall disease control .
CONCLUSIONS	Improvement in several indicators of asthma severity and control will be also investigated .
BACKGROUND	ClinicalTrials.gov Identifier : NCT02124226 ( assigned 25 April 2014 ) .

###24745852
BACKGROUND	Spinal anaesthesia performed at levels higher than the L3-4 intervertebral space may result in spinal cord injury .
BACKGROUND	Our aim was to establish a protocol to reduce the chance of spinal anaesthesia performed at or above L2-3 .
METHODS	One hundred and ten consenting patients at 32weeks of gestation or greater scheduled for non-emergency caesarean section under spinal anaesthesia were randomly allocated to have needle insertion performed at an intervertebral space determined by one of two landmark techniques .
METHODS	In Group A , if the intercristal line intersected an intervertebral space , this space was selected or if the intercristal line intersected a spinous process the space immediately above was selected .
METHODS	In Group B , if the intercristal line intersected an intervertebral space or a spinous process , the intervertebral space immediately below was chosen .
METHODS	The actual intervertebral space chosen was identified using ultrasound by a blinded investigator .
RESULTS	In Group A , an intervertebral space at or above L2-3 was marked in 25 ( 45.5 % ) patients compared with 4 ( 7.3 % ) in Group B ( P < 0.001 ) .
RESULTS	In 5/55 ( 9.1 % ) patients in Group A , the intervertebral space initially chosen was L1-2 whereas this occurred in no patient in Group B.
RESULTS	There was no difference between groups in number of needle passes or attempts , onset of block at 5 , 10 and 15min or need for rescue analgesia .
CONCLUSIONS	Our data suggest that when performing spinal anaesthesia in pregnant patients , if the intercristal line intersects an intervertebral space then the space below should be chosen and if the intercristal line intersects a spinous process then the interspace below should be chosen .
CONCLUSIONS	This will reduce the incidence of spinal anaesthesia performed at or above L2-3 .

###24888284
OBJECTIVE	The effectiveness of continuous renal replacement therapy ( CRRT ) increases when unplanned circuit failure is prevented .
OBJECTIVE	Adequate anticoagulation is an important component .
OBJECTIVE	Although heparin is the predominating anticoagulant , calcium chelation with citrate is an alternative , but systemic calcium monitoring and supplementation increase the complexity of CRRT .
OBJECTIVE	We assessed efficacy and safety of citrate delivery via integrated software algorithms against an established regional heparin protocol .
METHODS	Prospective computer randomisation allocated eligible patients to regional citrate or heparin between April and December 2012 .
METHODS	Citrate fluids were Prismocitrate 18 mmol/L predilution and Prism0cal B22 dialysate .
METHODS	Hemosol B0 was the default fluid for heparin .
METHODS	The primary outcome was filter running time .
METHODS	Electively terminated circuits were censored .
METHODS	Intention-totreat ( ITT ) and per-protocol analyses were performed .
METHODS	Filter survival was compared by log-rank tests and hazard ratios were explored with a mixed-effects Cox model .
RESULTS	221 filters were analysed from 30 patients ( of whom 19 were randomly allocated to citrate filters and 11 to heparin filters ) .
RESULTS	Patients randomly allocated to citrate were older , sicker , with a higher male : female ratio , but of similar weight .
RESULTS	Mortality was 37 % in the citrate arm and 27 % in the heparin arm .
RESULTS	All deaths were attributed to underlying disease .
RESULTS	Significant crossover occurred from the citrate arm to use of heparin .
RESULTS	Median filter survival , by ITT , was not significantly different ( citrate , 34 hours ; heparin , 30.7 hours ; P = 0.58 ) .
RESULTS	Per-protocol survival favoured citrate ( citrate , 42.1 hours ; heparin , 24 hours ; ( 2 ) = 8.1 ; P = 0.004 ) .
RESULTS	Considerable variation in filter life existed between patients , and between vascular access sites within patients .
RESULTS	Safety end points were reached in one heparin and three citrate patients .
CONCLUSIONS	Although the per-protocol results favoured citrate when it was actually delivered , the significant crossover between treatment arms hampered more definitive conclusions .
CONCLUSIONS	Until further studies support improved patient outcomes , increased complexity and complications suggest that anticoagulation choice be made using patient-specific indications .

###24560970
OBJECTIVE	To assess objective and subjective outcomes of retrograde intrarenal surgery ( RIRS ) and extracorporeal shock wave lithotripsy ( SWL ) for the treatment of intermediate size ( 1-2 cm ) inferior calyceal ( IC ) stones in a prospective randomized fashion .
METHODS	Between March 2011 and January 2013 , 70 symptomatic adults who had isolated IC stone between 10 and 20 mm underwent RIRS or SWL by computer-generated pseudorandom assignment ( 1:1 ) .
METHODS	Success rate , mean procedure time , hospital stay , pain score on day 1 and 2 using visual analog scale , analgesic requirement after discharge , complications , retreatment rate , auxiliary procedure , and patient-reported outcomes ( using self-made nonvalidated questionnaire ) were compared .
RESULTS	Baseline parameters and mean stone size ( SWL 16.45 2.28 mm , RIRS 15.05 3.56 mm ; P = .0542 ) were comparable .
RESULTS	Success rate was significantly higher after a single session of RIRS compared with 3 sessions of SWL ( 85 % vs 54 % ; P = .008 ) .
RESULTS	Retreatment rate ( 65 % vs 5.7 % ; P = .0001 ) and auxiliary procedure ( 45 % vs 8 % ; P = .0009 ) were significantly higher in SWL .
RESULTS	Pain score on postoperative day 1 and 2 was significantly higher in RIRS , but patients with SWL required significantly more analgesics afterward .
RESULTS	Most of the complications were of Clavien grade I and/or II in both groups .
RESULTS	Average time to return to normal activity and voiding symptoms were significantly higher in RIRS .
RESULTS	Overall satisfaction score ( 2.17 1.24 vs 2.82 1.17 ; P = .026 ) was significantly higher in RIRS than SWL .
CONCLUSIONS	For the treatment of intermediate size IC calculi , RIRS is superior to SWL in terms of objective and subjective outcomes .

###25863847
OBJECTIVE	To compare macular hole ( MH ) closure and visual acuity improvement after vitrectomy using SF6 versus C3F8 gas tamponade .
OBJECTIVE	The secondary purposes were to report the cumulative incidence of cataract development at 1 year after MH surgery and the proportion of complications .
METHODS	Prospective , randomized study .
METHODS	Thirty-one patients were prospectively randomized to the SF6 group and 28 patients to the C3F8 group .
METHODS	Preoperative data included MH minimum diameter , Early Treatment Diabetic Retinopathy Study ( ETDRS ) best corrected visual acuity ( BCVA ) , cataract staging , and intraocular pressure ( IOP ) measurement .
METHODS	Postoperative data included optical coherence tomography confirmation of the closure at 6 weeks and 1 year , and ETDRS BCVA and cataract development/extraction , both 1 year after the MH surgery .
RESULTS	Primary MH closure was achieved in 93.3 % in the SF6 group and 92.9 % in the C3F8 group .
RESULTS	Mean ETDRS BCVA improved by 17.7 letters in the SF6 and 16.9 letters in the C3F8 group .
RESULTS	The difference in cumulative incidence of cataract development and extraction between both groups was not statistically significant .
RESULTS	Regardless of the dye used , similar results were achieved .
RESULTS	Finally , the proportion of adverse events was similar in both groups .
CONCLUSIONS	MH surgery with SF6 gas achieves results similar to C3F8 in terms of visual acuity improvement , MH closure , cataract development/extraction , and adverse events .

###24598244
OBJECTIVE	Patients with latent autoimmune diabetes in adults ( LADA ) express autoantibodies against the 65-kDa isoform of GAD ( GADA ) .
OBJECTIVE	Intervention with recombinant human GAD65 formulated with aluminium hydroxide ( GAD-alum ) given twice subcutaneously to LADA patients at intervals of 4 weeks was safe and did not compromise - cell function in a Phase II clinical trial .
OBJECTIVE	GADA affinity has been shown to predict progression to type 1 diabetes .
OBJECTIVE	Here , we asked whether GADA affinity was affected by the GAD65 antigen-specific vaccination and/or associated with - cell function in participants of this trial .
METHODS	GADA affinity was measured in sera of 46 LADA patients obtained prior to the first week and 20 weeks after the second injection with GAD-alum or placebo using competitive binding experiments with [ 125I ] - labeled and unlabeled human GAD65 .
RESULTS	At baseline , GADA affinities ranged from 1.9 10 ( 7 ) to 5.0 10 ( 12 ) L/mol ( median 2.8 10 ( 10 ) L/mol ) and were correlated with GADA titers ( r = 0.47 ; P = 0.0009 ) , fasting ( r = -0.37 ; P = 0.01 ) and stimulated ( r = -0.40 ; P = 0.006 ) C-peptide concentrations , and HbA1c ( r = 0.39 ; P = 0.007 ) .
RESULTS	No significant changes in affinity were observed from baseline to week 24 .
RESULTS	Patients with GADA affinities in the lower first quartile ( < 4 10 ( 9 ) L/mol ) had better preserved fasting C-peptide concentrations at baseline than those with higher affinities ( mean 1.02 vs. 0.66 nmol/L ; P = 0.004 ) and retained higher concentrations over 30 months of follow-up ( mean 1.26 vs. 0.62 nmol/L ; P = 0.01 ) .
CONCLUSIONS	Intervention with GAD-alum in LADA patients had no effect on GADA affinity .
CONCLUSIONS	Our data suggest that patients with low GADA affinity have a prolonged preservation of residual - cell function .

###24896141
OBJECTIVE	Few studies support oral diabetic treatment in pregnant women with type 2 diabetes mellitus ( T2DM ) .
OBJECTIVE	The objective of this study was to compare the effects of metformin versus insulin on achieving glycemic control and improving maternal and neonatal outcomes in pregnant women with T2DM .
METHODS	A pilot randomized , controlled trial was conducted of metformin versus insulin for the treatment of T2DM during pregnancy .
METHODS	The primary outcome was glycemic control measured with hemoglobin A1c < 7 % at delivery .
METHODS	Maternal and neonatal outcomes were compared between groups .
RESULTS	In this study , 8 women received metformin and 11 received insulin .
RESULTS	All women in both groups achieved glycemic control by delivery ( HgbA1c : metformin 5.965.88 vs. insulin 6.340.92 % ) .
RESULTS	There were similar rates of cesarean delivery , birth weights , neonatal intensive care unit admissions , respiratory distress syndrome , and neonatal dextrose treatment between groups .
RESULTS	There was one case of fetal macrosomia in the insulin group , one case of shoulder dystocia in the metformin group and no cases of failed metformin therapy .
CONCLUSIONS	In this pilot study , glycemic control was achieved in women who received metformin and insulin .
CONCLUSIONS	Larger studies are needed to determine whether metformin can be considered a reasonable alternative to insulin in pregnant women with T2DM .

###24295013
OBJECTIVE	This in vitro study compared the effect of a concave with a straight-bevelled cavity margin on the microleakage of Class V composite resin restorations in primary teeth .
METHODS	Standardised Class V cavity preparations were made in vitro on the buccal ( all margins placed in enamel ) and on the lingual ( margins placed in enamel and cementum ) surfaces of 20 sound primary molars .
METHODS	The teeth were randomly assigned to two groups of 10 each : in Group 1 , a concave bevel was made with a high-speed No. 04 tungsten carbide bur and in Group 2 , a straight bevel was made with a high-speed No. 556 tungsten carbide bur .
METHODS	The teeth were restored incrementally with Adper Single Bond 2 ( 3M ) adhesive and Filtek Z 350 ( 3M ) composite resin .
METHODS	All specimens were subsequently thermocycled and immersed in 50 % silver nitrate solution .
METHODS	Microleakage of the restorations was then assessed by silver penetration .
METHODS	A grading scale of 0 to 4 was used as the scoring criterion .
RESULTS	At the enamel margins no statistically significant differences were observed between the two groups ( p >> 0.05 ) .
RESULTS	Occlusal walls in enamel , in both groups , exhibited less leakage than the cervical walls in cementum ( p < 0.01 ) and Group 1 showed better results than Group 2 in decreasing microleakage at the cementum margins ( p < 0.05 ) .
CONCLUSIONS	Based on the results , it was concluded that concave-beveled cavity preparations may reduce but did not totally eliminate microleakage at the cementum margins of Class V composite resin restorations in primary teeth .

###24382118
BACKGROUND	Computerized tomography DICOM file can be relatively easily transformed to a virtual 3D model .
BACKGROUND	With the help of additional software we are able to create the mirrored model of an undamaged orbit and on this basis produce an individual implant for the patient Authors decided to apply implants with any thickness , which are authors own invention to obtain volumetric support and more stable orbital wall reconstruction outcome .
BACKGROUND	Material of choice was ultra-high molecular weight polyethylene ( UHMWPE ) .
OBJECTIVE	The aim of this study was to present and compare functional results of individual reconstructions of orbital wall using either titanium mesh or ultra-high molecular weight polyethylene .
METHODS	57 consecutive patients affected by orbital wall fracture ( 46 males , 11 females , mean age 3414 year ) were treated in Department of Maxillofacial Surgery from 2010 to 2012 .
METHODS	In the first group we used patient specific treatment by titanium mesh shaped on a 3D printed model of a mirrored intact orbit ( 37 orbits ) or by individually manufactured UHMW-PE implantby CAM milling in second group ( 20 orbits ) .
METHODS	All of these patients were subjected to preoperative helical computerized tomography and consultation of an ophthalmologist ( including binocular single vision loss test - BSVL ) .
METHODS	Further on , patients were operated under general anaesthesia using transconjuctival approach .
METHODS	BSVL was again evaluated post-operationally in 1 month and 6 months later .
RESULTS	Functional treatment results ( BSVL ) for both groups were similar in 1 month as well as 6 months post operational time .
RESULTS	There was no statistically significant difference between these two groups .
CONCLUSIONS	This study of 6 months functional result assessment of pre-bent individual implants and CNC milled ultra-high molecular weight polyethylene of the orbital wall has shown it to be a predictable reconstruction method .
CONCLUSIONS	Individually shaped UHMWPE seems to be as good as pre-bent titanium mesh .

###25465217
OBJECTIVE	To assess the effect of a capsular tension ring ( CTR ) on the postoperative anterior chamber depth ( ACD ) .
METHODS	Vienna Institute for Research in Ocular Surgery , Department of Ophthalmology , Hanusch Hospital , Vienna , Austria .
METHODS	Prospective observer - and patient-masked randomized trial .
METHODS	Bilateral small-incision cataract surgery with implantation of a hydrophobic acrylic single-piece intraocular lens ( IOL ) ( Tecnis ZCB00 ) was performed using a standard technique .
METHODS	Each patient received a CTR in 1 eye ( CTR group ) and no CTR in the fellow eye ( control group ) .
METHODS	The ACD was measured preoperatively with biometry ( IOLMaster 500 ) and at 1 hour and 12 weeks postoperatively using partial coherence interferometry ( ACMaster ) .
METHODS	The subjective refraction was assessed at 12 weeks .
RESULTS	Sixty eyes ( 30 patients ) were included .
RESULTS	Preoperatively , the mean axial length was 23.36 mm 1.55 ( SD ) ( range 21.01 to 29.46 mm ) in the CTR group and 23.37 1.70 mm ( range 21.14 to 28.84 mm ) in the control group and the mean ACD was 3.06 0.45 mm ( range 2.25 to 4.16 mm ) and 3.03 0.47 mm ( range 2.18 to 4.10 mm ) , respectively .
RESULTS	The differences were not statistically significant ( P = .148 and P = .074 , respectively ) .
RESULTS	The mean postoperative ACD was 4.83 0.46 mm ( range 3.84 to 5.76 mm ) in the CTR group and 4.81 0.43 mm ( range 3.67 to 5.65 mm ) in the control group .
RESULTS	The difference between the groups was not statistically significant ( P = .329 ) .
CONCLUSIONS	Implantation of a CTR had no significant influence on the postoperative axial IOL position .
BACKGROUND	No author has a financial or proprietary interest in any material or method mentioned .

###24796937
BACKGROUND	Transfused blood may have immunomodulatory and proinflammatory effects .
BACKGROUND	We report the first randomized study exploring whether leukoreduced red blood cell ( RBC ) transfusion increases circulating proinflammatory mediators , markers of neutrophil activation , and the acute-phase response in critically ill adults .
METHODS	Eighty-four patients were recruited from six general intensive care units in the United Kingdom as part of a laboratory study nested within a parallel-group randomized trial comparing restrictive and liberal leukoreduced RBC transfusion strategies in critically ill patients aged more than 55years with measured hemoglobin concentrations of not more than 90g/L ( ClinicalTrials.gov NCT00944112 ) .
METHODS	Forty-one patients received transfusion and 43 did not receive transfusion .
METHODS	Plasma was sampled at baseline , 6 hours , and 24 hours after randomization or transfusion , and concentrations of interleukin ( IL ) -1 , IL-2 , IL-4 , IL-5 , IL-6 , IL-8 , IL-10 , IL-12-p70 , interferon - , tumor necrosis factor - , human neutrophil elastase , soluble L-selectin , and C-reactive protein were measured using cytokine bead array analysis and an enzyme-linked immunosorbent assay .
RESULTS	Patients who received transfusion did not have significantly different inflammatory biomarker plasma concentrations at the time points compared to those who did not receive transfusion , with the exception of IL-8 concentrations at 24 hours , which were reduced in the transfused group ( p = 0.02 ) .
RESULTS	After adjustment for baseline inflammatory biomarker concentrations , there were no significant differences between patients who received transfusion and those who did not .
CONCLUSIONS	Concentrations of measured biomarkers were not significantly increased during the first 24 hours after leukoreduced RBC transfusion .
CONCLUSIONS	These data do not support the contention that leukoreduced RBC transfusion is associated with a proinflammatory response in the general adult critically ill population .

###25789519
OBJECTIVE	To evaluate the influence of estrogen therapy and estrogen-progestin therapy on homocysteine and C-reactive protein levels in postmenopausal women .
METHODS	In total , 99 postmenopausal women were included in this double-blind , randomized clinical trial and divided into three groups : Group A used estrogen therapy alone ( 2.0 mg of 17-estradiol ) , Group B received estrogen-progestin therapy ( 2.0 mg of 17 - estradiol +1.0 mg of norethisterone acetate ) and Group C received a placebo ( control ) .
METHODS	The length of treatment was six months .
METHODS	Serum measurements of homocysteine and C-reactive protein were carried out prior to the onset of treatment and following six months of therapy .
RESULTS	After six months of treatment , there was a 20.7 % reduction in homocysteine levels and a 100.5 % increase in C-reactive protein levels in the group of women who used estrogen therapy .
RESULTS	With respect to the estrogen-progestin group , there was a 12.2 % decrease in homocysteine levels and a 93.5 % increase in C-reactive protein levels .
CONCLUSIONS	Our data suggested that hormone therapy ( unopposed estrogen or estrogen associated with progestin ) may have a positive influence on decreasing cardiovascular risk due to a significant reduction in homocysteine levels .

###25669083
BACKGROUND	Optimal pain management after video-assisted thoracic surgery ( VATS ) remains an open issue .
BACKGROUND	We prospectively studied the analgesic effect of intercostal analgegia ( ICA ) by comparison with epidural analgesia .
METHODS	Twenty-two patients undergoing VATS procedures were randomly divided into ICA ( n = 8 ) or epidural ( n = 14 ) group .
METHODS	Postoperatively 2 ml x hr ( -1 ) of 0.2 % ropivacaine was delivered continuously through intercostal or epidural catheter .
METHODS	Moreover , each group received the equal dose of fentanyl ( 0.25 x g ( -1 ) .
METHODS	kg ( -1 ) x hr ( -1 ) ) intravenously or epidurally .
METHODS	When no pain relief was achieved , iv fentanyl was given as a rescue .
METHODS	Requirement of additional fentanyl and pain score using a visual analogue scale ( VAS ) were documented for 19 hours .
RESULTS	The mean pain scores at rest , mobilization and with coghing were slightly higher in the ICA group .
RESULTS	Total additional dose of iv fentanyl was significantly different between the groups ( ICA 147 41 vs Epidural 39 15 g ; P = 0.015 ) .
RESULTS	Pain scores and fentanyl requirements spread over the lower range .
RESULTS	The mean of VAS in ICA group was less than 5 even at coughing , suggesting clinically irrelevant .
CONCLUSIONS	In patients with coagulopathy , multimodal approach using intercostal analgesia supplemented by intravenous patient-controlled analgesia may be an alternative to epidural analgesia for postoperative pain management .

###25538277
BACKGROUND	A/H3N2 variant ( H3N2v ) influenza may sustain human-to-human transmission , and an available candidate vaccine would be important .
METHODS	In this phase I , randomized , observer-blind , dose-ranging study , 627 healthy subjects 3 years of age were randomized to receive 2 vaccinations with H3N2c cell-culture-derived vaccine doses containing 3.75 g , 7.5 g , or 15 g hemagglutinin antigen of H3N2v with or without MF59 ( registered trademark of Novartis AG ) adjuvant ( an oil-in-water emulsion ) .
METHODS	This paper reports Day 43 planned interim data .
RESULTS	Single MF59-adjuvanted H3N2c doses elicited immune responses in almost all subjects regardless of antigen and adjuvant dose ; the Center for Biologics Evaluation Research and Review ( CBER ) licensure criteria were met for all groups .
RESULTS	Subjects with prevaccination hemagglutination inhibition titers < 10 and children 3 - < 9 years achieve CBER criteria only after receiving 2 doses of nonadjuvanted H3N2c vaccine .
RESULTS	Highest antibody titers were observed in the 7.5 g + 0.25 mL MF59 groups in all age cohorts .
RESULTS	MF59-adjuvanted H3N2c vaccines showed the highest rates of solicited local and systemic events , predominately mild or moderate .
CONCLUSIONS	A single dose of H3N2c vaccine may be immunogenic and supports further development of MF59-adjuvanted H3N2c vaccines , especially for pediatric populations .
BACKGROUND	ClinicalTrials.gov identifier NCT01855945 ( http://clinicaltrials.gov/ct2/show/NCT01855945 ) .

###24882900
OBJECTIVE	Insomnia , which is very common in patients with chronic low back pain ( LBP ) , has long been viewed as a pain symptom that did not merit specific treatment .
OBJECTIVE	Recent data suggest that adding insomnia therapy to pain-targeted treatment should improve outcome ; however , this has not been empirically tested in LBP or in any pain condition treated with a standardized pain medication regimen .
OBJECTIVE	We sought to test the hypothesis that adding insomnia therapy to pain-targeted treatment might improve sleep and pain in LBP .
METHODS	Double-blind , placebo-controlled , parallel-group , 1-mo trial .
METHODS	Duke University Medical Center Outpatient Sleep Clinic .
METHODS	Fifty-two adult volunteers with LBP of at least 3 mo duration who met diagnostic criteria for insomnia ( mean age : 42.5 y ; 63 % females ) .
METHODS	Subjects were randomized to eszopiclone ( ESZ ) 3 mg plus naproxen 500 mg BID or matching placebo plus naproxen 500 mg twice a day .
RESULTS	ESZ SIGNIFICANTLY IMPROVED TOTAL SLEEP TIME ( MEAN INCREASE : ESZ , 95 min ; placebo , 9 min ) ( primary outcome ) and nearly all sleep measures as well as visual analog scale pain ( mean decrease : ESZ , 17 mm ; placebo , 2 mm ) ( primary pain outcome ) , and depression ( mean Hamilton Depression Rating Scale improvement ESZ , 3.8 ; placebo , 0.4 ) compared with placebo .
RESULTS	Changes in pain ratings were significantly correlated with changes in sleep .
CONCLUSIONS	The addition of insomnia-specific therapy to a standardized naproxen pain regimen significantly improves sleep , pain , and depression in patients with chronic low back pain ( LBP ) .
CONCLUSIONS	The findings indicate the importance of administering both sleep and pain-directed therapies to patients with LBP in clinical practice and provide strong evidence that improving sleep disturbance may improve pain .
BACKGROUND	clinicaltrials.gov identifier : NCT00365976 .

###25141526
OBJECTIVE	The present study investigated the immediate effects of low frequency repetitive transcranial magnetic stimulation ( LF-rTMS ) combined with reach-to-grasp ( RTG ) training of the paretic hand in individuals with chronic stroke .
METHODS	Fourteen participants were randomly assigned to receive LF-rTMS or sham stimulation conditions .
METHODS	All participants underwent RTG training after the stimulation .
METHODS	Corticospinal excitability ( CE ) of the non-lesioned hemisphere , the total time of the wolf motor function test ( WMFT ) for dexterity tasks , maximum aperture , and movement time of RTG actions were evaluated at baseline , after the stimulation , and after RTG training .
RESULTS	Significant differences between interaction ( group x time ) were found in the total time of WMFT The CE of non-lesioned hemisphere diminished after LF-rTMS and showed moderate correlation with the reduction in time of RTG actions after the stimulation .
RESULTS	The total time of WMFT and RTG actions reduced after motor training only in the LF-rTMS group .
RESULTS	No change was observed in maximum aperture in either group .
CONCLUSIONS	The application of LF-rTMS combined with RTG training enhanced the training effect as evidenced by faster movement for the dexterity tasks of the paretic hand than RTG training alone .
CONCLUSIONS	The findings suggested the benefit of LF-rTMS for enhancing the training effects in stroke rehabilitation .

###25169962
BACKGROUND	Whether therapeutic drug monitoring of biologic therapy can predict the efficacy of adalimumab to prevent postoperative Crohn 's disease recurrence is unknown .
OBJECTIVE	To investigate whether adalimumab trough levels and anti-adalimumab antibodies correlate with endoscopic and clinical outcomes in a series of patients treated with prophylactic adalimumab monotherapy after resective surgery .
METHODS	Post hoc analysis of a randomized , mesalamine-controlled trial .
METHODS	Adalimumab trough levels and antibodies were analysed every 8 weeks for 2 years using an homogeneous mobility shift assay .
RESULTS	At two years , 1/6 patient had clinical recurrence and 1/6 patient had endoscopic and clinical recurrence .
RESULTS	At baseline ( 9.5 vs. 14.4 mcg/mL ) and during follow-up [ 7.5 ( 4.4-9 .8 ) vs. 13.9 ( 8.9-23 .6 ) mcg/mL , p < 0.01 ] , median adalimumab trough levels in patients with clinical or endoscopic recurrence were lower than in those who maintained remission .
RESULTS	Persistent antibodies-against-adalimumab were detected in the patient with both endoscopic and clinical recurrence .
CONCLUSIONS	Measurement of adalimumab trough levels and anti-adalimumab antibodies after surgery could be useful to further reduce postoperative recurrence .

###24530759
METHODS	We showed previously that rabbit ATG induction induces a strong decrease of CD4 + T cells together with impaired in vitro IL-2 secretion up to 1 year post-transplant .
METHODS	To further characterize long-term immunological effects of ATG induction 2 and 5 years post-transplant , we used sensitive intracellular cytokine analysis in the same prospective study of 84 renal transplant recipients ( ATG , n = 44 ) .
RESULTS	A significantly increased frequency of severe infectious disease ( HR = 2.0 , p = 0.027 ) as well as suppressed T cell functions were found within 2 years after ATG induction but not beyond ( logistic regression ( logreg ) : CD4 cell IL-10 responses , p = 0.064 ; T cell proliferation , p = 0.038 ) .
RESULTS	Impaired T cell proliferation at 2 years was associated with occurrence of severe infection ( p = 0.017 ) .
RESULTS	Importantly , a strong and persistent decrease of CD4 cell counts ( p < 0.0005 at 5 years ) was independently associated with ATG induction ( logreg p = 0.002 ) but not related to functional CD4 cell impairment ( helper activity/cytokine production ) or an increased risk of infection .
CONCLUSIONS	Severe infection up to 2 years after ATG induction was associated with impaired T cell proliferative capacity but not with the profound decline in CD4 cell counts that occurred after ATG induction and persisted up to 5 years .

###24277961
OBJECTIVE	To compare anxiolysis produced by intranasal clonidine with intranasal midazolam as premedication in children undergoing surgery .
METHODS	Double-blind randomized controlled study .
METHODS	Tertiary-care hospital , July 2009 to June 2010 .
METHODS	60 American Society of Anesthesiologists physical status I-II surgical patients aged 1-10 yr .
METHODS	Participants randomly allocated to receive either intranasal clonidine 4 mcg/kg ( Group I ) with atropine or intranasal midazolam 0.3 mg/kg ( Group II ) .
METHODS	Primary : satisfactory anxiolysis at 30 min after drug administration .
METHODS	Secondary : satisfactory mask acceptance , times of onset of sedation and anxiolysis , drug acceptance , level of sedation , wake-up score and side effects .
RESULTS	All children achieved satisfactory anxiolysis at 30 min .
RESULTS	Group I fared significantly better than GroupII on mask acceptance ( 100 % in Group I vs. 80 % in Group II ; P = 0.024 ) , drug acceptance ( 93 % vs. 13 % ; P < 0.001 ) and proportion of patients with satisfactory wake up scores ( 100 % vs. 53 % ; P < 0.001 ) .
RESULTS	Group II patients had significantly faster onset of sedation ( median 10 min vs. 15 min ; P < 0.05 ) but not that of anxiolysis compared to Group-I ( median 10 min for both groups ; P > 0.05 ) .
RESULTS	Side effects were significantly more frequent in Group II .
CONCLUSIONS	Though intranasal midazolam produced faster sedation , both the drugs produced satisfactory anxiolysis at 30 min .

###24753128
BACKGROUND	Few studies have investigated factors influencing participation rates for minority children with a chronic disease in clinical trials .
BACKGROUND	The Silent Cerebral Infarct Multi-Center Clinical ( SIT ) Trial provides an opportunity to study the impact of demographic and socio-economic factors on randomization in a clinical trial among Black children .
BACKGROUND	Our primary objective was to characterize the factors associated with successful randomization of children with sickle cell disease ( SCD ) and silent cerebral infarct ( SCI ) in the SIT Trial after initial consent .
METHODS	Differences in socio-economic and demographic variables , family history and disease-related variables were determined between eligible participants who were successfully randomized and those who were not randomized following initial consent .
METHODS	Head of household educational level and family income were examined separately for US versus non-US sites .
RESULTS	Of 1,176 children enrolled in the SIT Trial , 1,016 ( 86 % ) completed screening .
RESULTS	Of 208 ( 20 % ) children with qualifying SCI on pre-randomization MRI , 196 ( 94 % ) were successfully randomized .
RESULTS	There were no differences in socio-economic , demographic , or disease-related variables between children who were or were not randomized .
RESULTS	Participants from non-US sites were more likely to be randomized ( 22 % vs. 12 % , P = 0.011 ) ; although , randomization by country was associated with neither head of household education nor family income .
CONCLUSIONS	In the SIT Trial , acceptance of random allocation was not associated with socio-economic or demographic factors .
CONCLUSIONS	Although these factors may represent barriers for some participants , they should not bias investigators caring for children with SCD in their approach to recruitment for clinical trial participation .

###25270857
BACKGROUND	Acute pain is common during the endotracheal extubation period , and is related to complications and adverse outcomes .
BACKGROUND	Patients with delayed extubation after craniotomy are vulnerable to pain and complications of extubation .
BACKGROUND	However , pain control during extubation is still inadequate .
BACKGROUND	Remifentanil , a new opioid with rapid onset and short duration of action , provides adequate analgesia during procedures with minimal effect of respiratory depression .
METHODS	The study is a prospective , randomised , double-blinded , controlled parallel-group design .
METHODS	Patients with delayed extubation after intracranial surgery are screened daily .
METHODS	Adult patients ready for extubation are enrolled and assigned randomly to one of the two treatment study groups , labelled as the ` Remi group ' or ` Saline group ' .
METHODS	Patients in the Remi group receive an intravenous bolus dose of remifentanil 0.5 g/kg over 60s followed by a continuous infusion 0.05 g/kg/min for 20min .
METHODS	Patients in the Saline group receive an intravenous infusion of 0.9 % sodium chloride at a volume and rate equal to that of remifentanil .
METHODS	Pain intensity is measured by the visual analogue scale ( VAS ) pain score .
METHODS	Adverse events during drug infusion are documented and reported .
METHODS	Patients will be followed up until hospital discharge , death or 60days after the trial intervention on a first come , first served basis .
METHODS	Details of the incidence of reintubation and reoperation within 72h after extubation , length of stay in the intensive care unit and hospital and mortality are collected .
METHODS	The primary end point is the incidence of severe pain ( defined as a VAS pain score more than 5cm ) during the periextubation period ( defined as the period of time from immediately before extubation to 20min after extubation ) .
BACKGROUND	The study was approved by the Institutional Review Board ( IRB ) of the Beijing Tiantan Hospital , Capital Medical University .
BACKGROUND	The study findings will be disseminated through peer-reviewed publications and conference presentations .
BACKGROUND	ClinicalTrials ( NCT ) : ChiCTR-PRC-13003879 .

###25006684
OBJECTIVE	Virtually no clinical trials for smoking cessation have been undertaken in bipolar disorder .
OBJECTIVE	Varenicline has shown efficacy for smoking cessation , but warnings about neuropsychiatric adverse events have been issued .
OBJECTIVE	We assessed the efficacy and safety of varenicline in euthymic bipolar subjects motivated to quit smoking .
METHODS	Clinically stable adult patients with DSM-IV bipolar disorder ( n = 60 ) who smoked 10 cigarettes per day were randomized to a 3-month , double-blind , placebo-controlled varenicline trial and a 3-month follow-up .
METHODS	Study enrollment was completed from February 2010 through March 2013 .
METHODS	Varenicline was dosed using standard titration , and smoking cessation counseling was provided to all patients .
METHODS	The primary outcome was defined as a 7-day point prevalence of self-reported no smoking verified by expired carbon monoxide level < 10 ppm at 12 weeks .
METHODS	Psychopathology and side-effects were assessed at each visit .
RESULTS	At 3 months ( end of treatment ) , significantly more subjects quit smoking with varenicline ( n/n = 15/31 , 48.4 % ) than with placebo ( n/n = 3/29 , 10.3 % ) ( OR = 8.1 ; 95 % CI , 2.03-32 .5 ; P < .002 ) .
RESULTS	At 6 months , 6 of 31 varenicline-treated subjects ( 19.4 % ) remained abstinent compared to 2 of 29 ( 6.90 % ) assigned to placebo ( OR = 3.2 ; 95 % CI , 0.60-17 .6 ; P = .17 ) .
RESULTS	Psychopathology scores remained stable .
RESULTS	Ten serious adverse events occurred ( n = 6 , varenicline ; n = 4 , placebo ) .
RESULTS	Abnormal dreams occurred significantly more often in varenicline-treated subjects ( n/n = 18/31 , 61.3 % ) than in those receiving placebo ( n/n = 9/29 , 31 % ; Fisher exact test , P = .04 ) .
RESULTS	Eight varenicline-treated and 5 placebo-assigned subjects expressed fleeting suicidal ideation , a nonsignificant difference .
CONCLUSIONS	Varenicline shows efficacy for initiating smoking cessation in bipolar patients , but medication trials of longer duration are warranted for maintaining abstinence .
CONCLUSIONS	Vigilance for neuropsychiatric adverse events is prudent when initiating varenicline for smoking cessation in this patient population .
BACKGROUND	ClinicalTrials.gov identifier : NCT01010204 .

###24376009
OBJECTIVE	To examine the stability of severe pediatric obesity relative to moderate obesity and associated changes in cardiometabolic risk from the beginning of 6th to the end of 8th grade .
METHODS	Participants in HEALTHY , a multi-site , cluster randomized school-based study designed to mitigate risk for type 2 diabetes , completed standardized assessments of height , weight , glucose , insulin , lipids , and blood pressure at the beginning of 6th grade and the end of 8th grade .
METHODS	Youth were classified as moderately obese ( 100-119 % of the 95th percentile of BMI for age and gender ) or severely obese ( 120 % of the 95th percentile of BMI for age and gender ) .
METHODS	Generalized linear mixed models ( GLMM ) that controlled for relevant covariables were used to examine the relation between baseline demographic and cardiometabolic risk factors and BMI status , as well as changes in relative weight category and risk factors during middle school .
RESULTS	Severe obesity was more likely to endure over the course of middle school than was moderate obesity , and was associated with significantly higher levels of cardiometabolic risk .
CONCLUSIONS	Research with a specific focus on understanding , preventing , and treating severe obesity in children is warranted .

###25882764
OBJECTIVE	Infections caused by carbapenemase-producing Enterobacteriaceae are increasing worldwide , especially in ICUs , and have been associated with high mortality rates .
OBJECTIVE	However , unequivocally demonstrating causality of such infections to death is difficult in critically ill patients because of potential confounding and competing events .
OBJECTIVE	Here , we quantified the effects of carbapenemase-producing Enterobacteriaceae carriage on patient outcome in two Greek ICUs with carbapenemase-producing Enterobacteriaceae endemicity .
METHODS	Observational cohort study .
METHODS	Two ICUs with carbapenemase-producing Enterobacteriaceae endemicity .
METHODS	Patients admitted to the ICU with an expected length of ICU stay of at least 3 days were included .
METHODS	None .
RESULTS	Carbapenemase-producing Enterobacteriaceae colonization was established through screening in perineum swabs obtained at admission and twice weekly and inoculated on chromogenic plates .
RESULTS	Detection of carbapenemases was performed phenotypically , with confirmation by polymerase chain reaction .
RESULTS	Risk factors for ICU mortality were evaluated using cause-specific hazard ratios and subdistribution hazard ratios , with carbapenemase-producing Enterobacteriaceae colonization as time-varying covariate .
RESULTS	One thousand seven patients were included , 36 ( 3.6 % ) were colonized at admission , and 96 ( 9.5 % ) acquired carbapenemase-producing Enterobacteriaceae colonization during ICU stay , and 301 ( 29.9 % ) died in ICU .
RESULTS	Of 132 carbapenemase-producing Enterobacteriaceae isolates , 125 ( 94.7 % ) were Klebsiella pneumoniae and 74 harbored K. pneumoniae carbapenemase ( 56.1 % ) , 54 metallo -- lactamase ( 40.9 % ) , and four both ( 3.0 % ) .
RESULTS	Carbapenemase-producing Enterobacteriaceae colonization was associated with a statistically significant increase of the subdistribution hazard ratio for ICU mortality ( subdistribution hazard ratio = 1.79 ; 95 % CI , 1.31-2 .43 ) , not explained by an increased daily hazard of dying ( cause-specific hazard ratio for death = 1.02 ; 95 % CI , 0.74-1 .41 ) , but by an increased length of stay ( cause-specific hazard ratio for discharge alive = 0.73 ; 95 % CI , 0.51-0 .94 ) .
RESULTS	Other risk factors in the subdistribution hazard model were Acute Physiology and Chronic Health Evaluation II score ( subdistribution hazard ratio = 1.13 ; 95 % CI , 1.11-1 .15 ) , female gender ( subdistribution hazard ratio = 1.29 ; 95 % CI , 1.02-1 .62 ) , presence of solid tumor ( subdistribution hazard ratio = 1.54 ; 95 % CI , 1.15-2 .06 ) , hematopoietic malignancy ( subdistribution hazard ratio = 1.61 ; 95 % CI , 1.04-2 .51 ) , and immunodeficiency ( subdistribution hazard ratio = 1.59 ; 95 % CI , 1.11-2 .27 ) .
CONCLUSIONS	Patients colonized with carbapenemase-producing Enterobacteriaceae have on average a 1.79 times higher hazard of dying in ICU than noncolonized patients , primarily because of an increased length of stay .

###25150607
BACKGROUND	The extubation phase is an extremely critical moment in patients who have undergone orthotopic liver transplantation , who do not always have the advantage of long-lasting positive-pressure ventilation and positive expiratory end pressure ; these factors can lead to splanchnic venous congestion , and this is why a rapid extubation can represent a great benefit for the graft .
METHODS	The aim of this study was to compare the adaptive support ventilation ( ASV ) mode with the standard mode of weaning in our intensive care unit , synchronized intermittent mandatory ventilation with pressure support ( P-SIMV ) , in patients who received orthotopic liver transplantation .
METHODS	ASV is a positive-pressure mode , in which pressure level and respiratory rate are automatically adjusted according to measured lung dynamics at each breath .
METHODS	Eligible patients were assigned to either ASV or P-SIMV group .
METHODS	The weaning protocol was based on the individual respiratory activity and structured in 4 different phases .
RESULTS	The average length of intubation was significantly shorter in the ASV group than in the P-SIMV group ( 9013 vs 15322 minutes , P = .05 ) .
RESULTS	The total modifications to the ventilator settings were significantly larger in the P-SIMV group ( 1.51 vs 62 ; P = .003 ) .
CONCLUSIONS	Our results suggest that although both procedures are safe and easy to apply , ASV is superior in terms of weaning times , and it simplifies respiratory management .
CONCLUSIONS	The better patient-machine interaction in ASV has been highlighted by other authors for different clusters of patients .

###25981818
BACKGROUND	In the international randomised phase 3 CORRECT trial ( NCT01103323 ) , regorafenib significantly improved overall survival versus placebo in patients with treatment-refractory metastatic colorectal cancer .
BACKGROUND	Of the 760 patients in CORRECT , 111 were Asian ( mostly Japanese ) .
BACKGROUND	This phase 3 trial was done to assess regorafenib in a broader population of Asian patients with refractory metastatic colorectal cancer than was studied in CORRECT .
METHODS	In this randomised , double-blind , placebo-controlled , parallel-group , phase 3 trial done in 25 hospitals in mainland China , Hong Kong , South Korea , Taiwan , and Vietnam , we recruited Asian patients aged 18 years or older with progressive metastatic colorectal cancer who had received at least two previous treatment lines or were unable to tolerate standard treatments .
METHODS	Patients had to have an Eastern Cooperative Oncology Group performance status of 0 or 1 , life expectancy of at least 3 months , and adequate bone marrow , liver , and renal function , without other uncontrolled medical disorders .
METHODS	We randomly allocated patients ( 2:1 ; with a computer-generated unicentric randomisation list [ prepared by the study funder ] and interactive voice response system ; block size of six ; stratified by metastatic site [ single vs multiple organs ] and time from diagnosis of metastatic disease [ < 18 months vs 18 months ] ) to receive oral regorafenib 160 mg once daily or placebo on days 1-21 of each 28 day cycle ; patients in both groups were also to receive best supportive care .
METHODS	Participants , investigators , and the study funder were masked to treatment assignment .
METHODS	The primary endpoint was overall survival , and we analysed data on an intention-to-treat basis .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01584830 .
RESULTS	Between April 29 , 2012 , and Feb 6 , 2013 , we screened 243 patients and randomly assigned 204 patients to receive either regorafenib ( 136 [ 67 % ] ) or placebo ( 68 [ 33 % ] ) .
RESULTS	After a median follow-up of 74 months ( IQR 43-122 ) , overall survival was significantly better with regorafenib than it was with placebo ( hazard ratio 055 , 95 % CI 040-077 , one-sided p = 000016 ; median overall survival 88 months [ 95 % CI 73-98 ] in the regorafenib group vs 63 months [ 48-76 ] in the placebo group ) .
RESULTS	Drug-related adverse events occurred in 132 ( 97 % ) of 136 regorafenib recipients and 31 ( 46 % ) of 68 placebo recipients .
RESULTS	The most frequent grade 3 or higher regorafenib-related adverse events were hand-foot skin reaction ( 22 [ 16 % ] of 136 patients in the regorafenib group vs none in the placebo group ) , hypertension ( 15 [ 11 % ] vs two [ 3 % ] of 68 patients in the placebo group ) , hyperbilirubinaemia ( nine [ 7 % ] vs one [ 1 % ] ) , hypophosphataemia ( nine [ 7 % ] vs none ) , alanine aminotransferase concentration increases ( nine [ 7 % ] vs none ) , aspartate aminotransferase concentration increases ( eight [ 6 % ] vs none ) , lipase concentration increases ( six [ 4 % ] vs one [ 1 % ] ) , and maculopapular rash ( six [ 4 % ] vs none ) .
RESULTS	Drug-related serious adverse events occurred in 12 ( 9 % ) patients in the regorafenib group and three ( 4 % ) in the placebo group .
CONCLUSIONS	This phase 3 trial is the second to show an overall survival benefit with regorafenib compared with placebo in patients with treatment-refractory metastatic colorectal cancer , substantiating the role of regorafenib as an important treatment option for patients whose disease has progressed after standard treatments .
CONCLUSIONS	In this trial , preceding standard treatments did not necessarily include targeted treatments .
CONCLUSIONS	Adverse events were generally consistent with the known safety profile of regorafenib in this setting .
BACKGROUND	Bayer HealthCare Pharmaceuticals .

###26290082
BACKGROUND	Lumbar discectomy and laminectomy in patients with intervertebral disc herniation ( IDH ) is common , with variable reported reoperation rates .
BACKGROUND	Our study examined which baseline characteristics might be risk factors for reoperation and compared outcomes between patients who underwent reoperation and those who did not .
METHODS	We performed a retrospective subgroup analysis of patients from the IDH arm of the Spine Patient Outcomes Research Trial ( SPORT ) randomized and observational cohorts .
METHODS	We analyzed baseline characteristics and outcomes of patients who underwent reoperation and those who did not with use of data collected from enrollment through eight-years of follow-up after surgery .
METHODS	Follow-up times were measured from the time of surgery , and baseline covariates were updated to the follow-up immediately preceding the time of surgery for outcomes analyses .
RESULTS	At eight years , the reoperation rate was 15 % ( 691 no reoperation ; 119 reoperation ) .
RESULTS	Sixty-two percent of these patients underwent reoperation because of a recurrent disc herniation ; 25 % , because of a complication or other factor ; and 11 % , because of a new condition .
RESULTS	The proportion of reoperations that were performed for a recurrent disc herniation ranged from 58 % to 62 % in the individual years .
RESULTS	Older patients were less likely to have reoperation ( p = 0.015 ) , as were patients presenting with asymmetric motor weakness at baseline ( p = 0.0003 ) .
RESULTS	Smoking , diabetes , obesity , Workers ' Compensation , and clinical depression were not associated with a greater risk of reoperation .
RESULTS	Scores on the Short Form ( SF ) -36 for bodily pain and physical functioning , the Oswestry Disability Index ( ODI ) , and the Sciatica Bothersomeness Index as well as satisfaction with symptoms had improved less at the time of follow-up in the reoperation group ( p < 0.001 ) .
CONCLUSIONS	In patients who underwent surgery for IDH , the overall reoperation rate was 15 % at the eight-year follow-up .
CONCLUSIONS	Patients of older age and patients presenting with asymmetric motor weakness were less likely to undergo a reoperation .
CONCLUSIONS	Less improvement in patient-reported outcomes was noted in the reoperation group .

###25359128
BACKGROUND	Asthma is a common disease that affects people of all ages and has significant morbidity and mortality .
BACKGROUND	Poor outcomes and health disparities related to asthma result in part from the difficulty of disseminating new evidence and care delivery methods such as shared decision making ( SDM ) into clinical practice .
METHODS	This non-blinded study will randomize 30 primary care clinics in NC stratified by four PBRNs .
METHODS	We will test dissemination across these practices using a facilitator-led participatory approach to dissemination ( FLOW ) , a novel method of participatory dissemination involving key principles of community-based participatory research , and a more typical `` lunch and learn '' dissemination method .
METHODS	Specifically , we will use cluster randomization to assign each of the 30 practices to one of three arms : ( 1 ) control , no dissemination ; ( 2 ) traditional dissemination , one didactic session a year and distribution of educational material ; and ( 3 ) FLOW dissemination .
METHODS	We hypothesize that at the unit of randomization , the clinic , patients in the FLOW dissemination arm will be more likely to share in their treatment decisions compared to patients in the traditional dissemination or control arms .
METHODS	All outcomes will be measured at the level of the clinic .
METHODS	Adoption of the SDM approach will be evaluated by 1 ) asthma exacerbations , 2 ) level of patient involvement in the decision making process , and 3 ) qualitative assessments from patients and providers .
BACKGROUND	The trial was registered on January 27 , 2014 through the United States National Institutes of Health 's ClinicalTrials.gov NCT02047929 and funded by the Patient-Centered Outcomes Research Institute ( PCORI ) .

###24913337
OBJECTIVE	Adverse events ( AEs ) are health related events , reported by participants in clinical trials .
OBJECTIVE	We describe AEs in the PACE trial of treatments for chronic fatigue syndrome ( CFS ) and baseline characteristics associated with them .
METHODS	AEs were recorded on three occasions over one year in 641 participants .
METHODS	We compared the numbers and nature of AEs between treatment arms of specialist medical care ( SMC ) alone , or SMC supplemented by adaptive pacing therapy ( APT ) , cognitive behaviour therapy ( CBT ) or graded exercise therapy ( GET ) .
METHODS	We examined associations with baseline measures by binary logistic regression analyses , and compared the proportions of participants who deteriorated by clinically important amounts .
RESULTS	Serious adverse events and reactions were infrequent .
RESULTS	Non-serious adverse events were common ; the median ( quartiles ) number was 4 ( 2 , 8 ) per participant , with no significant differences between treatments ( P = .47 ) .
RESULTS	A greater number of NSAEs were associated with recruitment centre , and baseline physical symptom count , body mass index , and depressive disorder .
RESULTS	Physical function deteriorated in 39 ( 25 % ) participants after APT , 15 ( 9 % ) after CBT , 18 ( 11 % ) after GET , and 28 ( 18 % ) after SMC ( P < .001 ) , with no significant differences in worsening fatigue .
CONCLUSIONS	The numbers of adverse events did not differ significantly between trial treatments , but physical deterioration occurred most often after APT .
CONCLUSIONS	The reporting of non-serious adverse events may reflect the nature of the illness rather than the effect of treatments .
CONCLUSIONS	Differences between centres suggest that both standardisation of ascertainment methods and training are important when collecting adverse event data .

###24689247
OBJECTIVE	The principal objective of the present work was to examine the effects of mind state ( mind-wandering vs. on-task ) on driving performance in a high-fidelity driving simulator .
BACKGROUND	Mind-wandering is thought to interfere with goal-directed thought .
BACKGROUND	It is likely , then , that when driving , mind-wandering might lead to impairments in critical aspects of driving performance .
BACKGROUND	In two experiments , we assess the extent to which mind-wandering interferes with responsiveness to sudden events , mean velocity , and headway distance .
METHODS	Using a car-following procedure in a high-fidelity driving simulator , participants were probed at random times to indicate whether they were on-task at that moment or mind-wandering .
METHODS	The dependent measures were analyzed based on the participant 's response to the probe .
RESULTS	Compared to when on-task , when mind-wandering participants showed longer response times to sudden events , drove at a higher velocity , and maintained a shorter headway distance .
CONCLUSIONS	Collectively , these findings indicate that mind-wandering affects a broad range of driving responses and may therefore lead to higher crash risk .
CONCLUSIONS	The results suggest that situations that are likely associated with mind-wandering ( e.g. , route familiarity ) can impair driving performance .

###26258451
OBJECTIVE	No study has examined the effects of the combination of respiratory muscle training ( RMT ) and abdominal drawing-in maneuver ( ADIM ) on respiratory muscle activity and function in stroke patients during early pulmonary rehabilitation .
OBJECTIVE	The purpose of this study was to investigate the effects of RMT combined with ADIM on decreased respiratory muscle activity and function in patients with post-stroke hemiplegia .
METHODS	Thirty-seven subjects with post-stroke hemiplegia were randomly allocated to three groups ; integrated training group ( ITG ) , respiratory muscle training group ( RMTG ) , and control group ( CG ) .
METHODS	All of the subjects received routine therapy for stroke rehabilitation for 1 hour , five times a week for 6 weeks .
METHODS	Especially , the ITG received RMT using an incentive respiratory spirometer and ADIM using a Stabilizer , and the RMTG only received RMT using incentive respiratory spirometer for 15 minutes a day , five times a week for 6 weeks .
METHODS	Pulmonary function was evaluated using spirometry for measuring the forced vital capacity ( FVC ) and force expiratory volume in 1 second ( FEV1 ) .
METHODS	Additional surface electromyography ( sEMG ) analysis was included by measuring the respiratory muscle activity .
RESULTS	Our results showed that changes between the pre - and post-test values of FVC ( F = 12.50 , P = 0.02 ) and FEV1 ( F = 12.81 , P = 0.01 ) ( P < 0.05 ) in the ITG were significantly ( P < 0.05 ) greater .
RESULTS	Changes in EMG activation of the diaphragm ( F = 13.75 , P = 0.003 ) and external intercostal ( F = 14.33 , P = 0.002 ) ( P < 0.01 ) muscles of patients in the ITG during maximal static inspiratory efforts were significantly ( P < 0.05 ) greater than those in patients of the RMTG and the CG at post-test .
CONCLUSIONS	Our findings suggested that RMT combined with ADIM could improve pulmonary function in patients with post-stroke hemiplegia .

###25029833
OBJECTIVE	To study the effects of transcutaneous electrical nerve stimulation on multimodal analgesia after total knee arthroplasty .
METHODS	Sixty patients diagnosed as knee osteoarthritis and suffered unilateral total knee arthroplasty in the department of orthopedics , Zhejiang Traditional Chinese Medicine Hospital from March 2009 to May 2012 were randomly divided into control group and test group , 30 cases in each group .
METHODS	All the patients received celecoxib preoperatively , knee periarticular injection with the drug mixture intraoperatively , and celecoxib and morphine sulfate controlled-release tablets postoperatively .
METHODS	The patients in the test group were also treated with transcutaneous electrical nerve stimulation each day after operation .
METHODS	All the patients started doing functional exercises at 24 h after operation .
METHODS	Postoperative visual analogue scales ( VAS ) , passive and active range of motion of knee joint , and complications were recorded .
RESULTS	The VAS scores of test group during postoperative 24 h to 1 week were 3.39 + / - 0.69 , 2.79 + / - 0.51 , 2.16 + / - 0.52 , and 1.07 + / - 0.57 separately , which were lower than 3.80 + / - 0.86 , 3.22 + / - 0.58 , 2.53 + / - 0.54 and 1.38 + / - 0.52 in the control group .
RESULTS	The passive and active range of knee joint motion in the test group during postoperative 24 h to 2 weeks were ( 30.67 + / - 3.65 ) degrees , ( 39.17 + / - 3.96 ) degrees , ( 47.83 + / - 4.86 ) degrees , ( 93.67 + / - 7.30 ) degrees , ( 107.67 + / - 7.51 ) degrees and ( 29.83 + / - 5.33 ) degrees , ( 78.33 + / - 8.24 ) degrees , ( 95.17 + / - 5.94 ) degrees respectively , which were higher than ( 28.67 + / - 3.92 ) degrees , ( 36.83 + / - 4.25 ) degrees , ( 45.17 + / - 5.17 ) degrees , ( 89.83 + / - 7.25 ) degrees , ( 103.17 + / - 7.37 ) degrees and ( 24.17 + / - 10.26 ) degrees , ( 73.83 + / - 9.07 ) degrees , ( 91.33 + / - 7.42 ) degrees in the control group .
RESULTS	In the test group , 19 patients had ring-shaped haemostasis impression to some extent in the skin of knee joint to different degree , and 5 patients had blister formation .
CONCLUSIONS	It is meaningful to apply transcutaneous electrical nerve stimulation for treating multimodal analgesia after total knee arthroplasty , which can not only relieve patients ' postoperative pain , and also promote the rehabilitation of knee function as far as possible .

###24411682
BACKGROUND	Current efforts to improve clinical effectiveness and utility of repetitive transcranial magnetic stimulation ( rTMS ) in the treatment of major depression ( MD ) include theta burst stimulation ( TBS ) , a patterned form of rTMS .
BACKGROUND	Here , we investigated the efficacy of bilateral TBS to the dorsolateral prefrontal cortex ( dlPFC ) in patients with MD in additon to ongoing medication and psychotherapy .
METHODS	In this randomized-controlled trial , thirty-two patients with MD were treated for six weeks ( thirty sessions ) with either successively intermittent , activity enhancing TBS ( iTBS ) to the left and continuous , inhibiting TBS ( cTBS ) to the right dlPFC or with bilateral sham stimulation .
METHODS	Primary outcome measure was the proportion of treatment response defined as a Montgomery-sberg Depression Rating Scale ( MADRS ) 50 % compared to baseline .
METHODS	Secondary outcomes comprised response and remission rates of the Hamilton Depression Rating Scale ( HAMD ) and the Beck Depression Inventory ( BDI ) .
RESULTS	A larger number of responders were found in the cTBS ( n = 9 ) compared to the sham-stimulation ( n = 4 ) group ( odds ratio : 3.86 ; Wald ( 2 ) = 3.9 , p = 0.048 ) .
RESULTS	On secondary endpoint analysis , patient-reported outcome as assessed by the BDI , pointed towards a higher rate of remitters in the cTBS ( n = 6 ) than in the sham ( n = 1 ) group ( odds ratio : 9 ; Wald ( 2 ) = 3.5 , p = 0.061 ) .
CONCLUSIONS	With regard to the pilot character of the study and the small sample size , the results have to be considered as preliminary .
CONCLUSIONS	These findings provide first evidence that six weeks treatment of MDD with iTBS to the left and cTBS to the right dlPFC for six weeks is safe , feasible and superior to sham stimulation applied add-on to pharmacological and psychotherapeutic treatment .

###25838249
OBJECTIVE	The time of lung cancer screening may provide the ideal setting to discuss and initiate a smoking cessation plan that includes pharmacologic aids .
OBJECTIVE	No studies to date have fully investigated the potential effectiveness of such combined approach .
METHODS	We prospectively evaluated the biochemically verified 1-year continuous abstinence rate from smoking of 187 persistent smokers enrolled within the Multicentric Italian Lung Detection Trial ( MILD ) , who received a pharmacologic aid to quit smoking with varenicline along with behavioral counseling .
METHODS	The propensity of study subjects to succeed in smoking cessation was also monitored .
RESULTS	At 12 months , the continuous abstinence rate from smoking was achieved in 37 out of 187 patients ( 19.8 % ) , with a propensity to succeed in smoking cessation for the assisted attempt equal to 1.43 , as compared to an unassisted MILD patient .
RESULTS	At the end of the third month of therapy , 48.7 % of subjects showed a continuous abstinence rate , while only 33.7 % of patients were abstinent from smoking at 6 months .
RESULTS	At baseline , the subgroup of MILD participants who were originally allocated to lung tomography showed higher smoking intensity than those allocated to no screening .
CONCLUSIONS	A combined smoking cessation intervention can be implemented with satisfactory results within a lung cancer screening program ; this preliminary observation needs to be replicated in a prospective investigation .
CONCLUSIONS	Clinicians should consider that lung cancer screening may be falsely reassuring for persistent smokers ; therefore it should always be coupled with a smoking cessation program .

###25593483
OBJECTIVE	To evaluate the new RetroView colonoscope and compare its ability to detect simulated polyps `` hidden '' behind colonic folds with that of a conventional colonoscope , utilizing anatomic colon models .
METHODS	Three anatomic colon models were prepared , with twelve simulated polyps `` hidden '' behind haustral folds and five placed in easily viewed locations in each model .
METHODS	Five blinded endoscopists examined two colon models in random order with the conventional or RetroView colonoscope , utilizing standard withdrawal technique .
METHODS	The third colon model was then examined with the RetroView colonoscope withdrawn initially in retroflexion and then in standard withdrawal .
METHODS	Polyp detection rates during standard and retroflexed withdrawal of the conventional and RetroView colonoscopes were determined .
METHODS	Polyp detection rates for combined standard and retroflexed withdrawal ( combination withdrawal ) with the RetroView colonoscope were also determined .
RESULTS	For hidden polyps , retroflexed withdrawal using the RetroView colonoscope detected more polyps than the conventional colonoscope in standard withdrawal ( 85 % vs 12 % , P = 0.0001 ) .
RESULTS	For hidden polyps , combination withdrawal with the RetroView colonoscope detected more polyps than the conventional colonoscope in standard withdrawal ( 93 % vs 12 % , P 0.0001 ) .
RESULTS	The RetroView colonoscope in `` combination withdrawal '' was superior to other methods in detecting all ( hidden + easily visible ) polyps , with successful detection of 80 of 85 polyps ( 94 % ) compared to 28 ( 32 % ) polyps detected by the conventional colonoscope in standard withdrawal ( P < 0.0001 ) and 67 ( 79 % ) polyps detected by the RetroView colonoscope in retroflexed withdrawal alone ( P < 0.01 ) .
RESULTS	Continuous withdrawal of the colonoscope through the colon model while retroflexed was achieved by all endoscopists .
RESULTS	In a post-test survey , four out of five colonoscopists reported that manipulation of the colonoscope was easy or very easy .
CONCLUSIONS	In simulated testing , the RetroView colonoscope increased detection of hidden polyps .
CONCLUSIONS	Combining standard withdrawal with retroflexed withdrawal may become the new paradigm for `` complete screening colonoscopy '' .

###24607075
BACKGROUND	Parents of children and adolescents with diabetes type 1 ( DT1 ) usually experience high stress levels , as they have to cope with multiple demands in their everyday life .
BACKGROUND	Different complex interventions have been implemented , which sometimes have led to opposite results .
OBJECTIVE	The purpose of this study was to assess stress levels in parents of children and adolescents with DT1 and to evaluate the effectiveness of a stress management program ( progressive muscle relaxation combined with diaphragmatic breathing ) in reducing perceived and parenting stress , increasing internal locus of control , promoting healthy lifestyle , and normalizing cortisol levels .
METHODS	Randomized controlled trial .
METHODS	A total of 44 parents were randomly assigned to the intervention group ( performing relaxation for eight weeks , n = 19 ) and control group ( n = 25 ) .
METHODS	Pre-post measurements included cortisol levels , lifestyle characteristics , perceived stress , perception of health , and parenting stress .
RESULTS	A statistically significant decrease in perceived stress ( from 27.21 to 19.00 , P = .001 ) , as well as in parenting stress ( from 85.79 to 73.68 , P = .003 ) , was observed in the intervention group .
RESULTS	A statistically significant difference was found in perceived stress between the two groups after the intervention ( Dmean = 6.64 , P = .010 ) .
RESULTS	No significant difference was revealed between or within the groups in cortisol levels .
RESULTS	Significant improvement was reported by the subjects of the intervention group in various lifestyle parameters .
CONCLUSIONS	Relaxation techniques seem to have a positive impact on stress and on various lifestyle factors in parents of children and adolescents with DT1 .
CONCLUSIONS	Future research on long-term benefits of an intervention program comprising of various relaxation schemes is warranted .

###25326876
BACKGROUND	Consumption of a cholesterol lowering dietary portfolio including plant sterols ( PS ) , viscous fibre , soy proteins and nuts for 6 months improves blood lipid profile .
BACKGROUND	Plant sterols reduce blood cholesterol by inhibiting intestinal cholesterol absorption and concerns have been raised whether PS consumption reduces fat soluble vitamin absorption .
OBJECTIVE	The objective was to determine effects of consumption of a cholesterol lowering dietary portfolio on circulating concentrations of PS and fat soluble vitamins .
METHODS	Using a parallel design study , 351 hyperlipidemic participants from 4 centres across Canada were randomized to 1 of 3 groups .
METHODS	Participants followed dietary advice with control or portfolio diet .
METHODS	Participants on routine and intensive portfolio involved 2 and 7 clinic visits , respectively , over 6 months .
RESULTS	No changes in plasma concentrations of and tocopherol , lutein , lycopene and retinol , but decreased - carotene concentrations were observed with intensive ( week 12 : p = 0.045 ; week 24 : p = 0.039 ) and routine ( week 12 : p = 0.031 ; week 24 : p = 0.078 ) portfolio groups compared to control .
RESULTS	However , cholesterol adjusted - carotene and fat soluble compound concentrations were not different compared to control .
RESULTS	Plasma PS concentrations were increased with intensive ( campesterol :p = 0.012 ; - sitosterol :p = 0.035 ) and routine ( campesterol : p = 0.034 ; - sitosterol : p = 0.080 ) portfolio groups compared to control .
RESULTS	Plasma cholesterol-adjusted campesterol and - sitosterol concentrations were negatively correlated ( p < 0.001 ) with total and LDL-C levels .
CONCLUSIONS	Results demonstrate that consuming a portfolio diet reduces serum total and LDL-C levels while increasing PS values , without altering fat soluble compounds concentrations .
CONCLUSIONS	The extent of increments of PS with the current study are not deleterious and also maintaining optimum levels of fat soluble vitamins are of paramount necessity to maintain overall metabolism and health .
CONCLUSIONS	Results indicate portfolio diet as one of the best options for CVD risk reduction .
BACKGROUND	clinicaltrials.gov Identifier : NCT00438425 .

###24502652
OBJECTIVE	To better understand the role of the professional oral health care for elderly in improving geriatric oral health , the effects of short-term professional oral health care ( once per week for 1 month ) on oral microbiological parameters were assessed .
METHODS	Parallel , open-labelled , randomize-controlled trial was undertaken in a nursing home for elderly in Shizuoka , Japan .
METHODS	Thirty-four dentate elderly over 74 years were randomly assigned from ID number to the intervention ( 17/34 ) and control ( 17/34 ) groups .
METHODS	The outcomes were changes in oral microbiological parameters ( number of bacteria in unstimulated saliva ; whole bacteria , Streptococcus , Fusobacterium and Prevotella : opportunistic pathogens detection : and index of oral hygiene evaluation [ Dental Plaque Index , DPI ] ) within the intervention period .
METHODS	Each parameter was evaluated at before and after intervention period .
METHODS	Four elderly were lost from mortality ( 1 ) , bone fracture ( 1 ) , refused to participate ( 1 ) and multi-antibiotics usage ( 1 ) .
METHODS	Finally , 30 elderly were analysed ( 14/intervention and 16/control ) .
RESULTS	At baseline , no difference was found between the control and intervention groups .
RESULTS	After the intervention period , the percentage of Streptococcus species increased significantly in the intervention group ( Intervention , 86 % [ 12/14 ] ; Control , 50 % [ 8/16 ] : Fisher 's , right-tailed , P < 0.05 ) .
RESULTS	Moreover , DPI significantly improved in the intervention group ( Intervention , 57 % [ 8/14 ] ; Control , 13 % [ 2/16 ] : Fisher 's , two-tailed , P < 0.05 ) .
RESULTS	The improvement in DPI extended for 3 months after intervention .
RESULTS	None of side effects were reported .
CONCLUSIONS	The short-term professional oral health care can improve oral conditions in the elderly .

###25295770
BACKGROUND	Physical activity guidelines recommend engaging in moderate - and vigorous-intensity physical activity to elicit health benefits .
BACKGROUND	Similarly , these higher intensity ranges for activity are typically targeted in healthy living interventions ( ie , exercise prescription ) .
BACKGROUND	Comparatively less attention has been focused on changing lower intensity physical activity ( ie , sedentary activity ) behaviors .
BACKGROUND	The purpose of this study was to explore the effects of prescribing changes to physical activity of various intensities ( ie , sedentary through exercise ) through the primary care setting .
METHODS	Sixty older adults ( aged 55-75 years ; mean age 63 = 5 years ) volunteered to participate , and were randomly assigned to 4 groups : 3 receiving an activity prescription intervention targeting a specific intensity of physical activity ( exercise , sedentary , or both ) , and 1 control group .
METHODS	During the 12-week intervention period participants followed personalized activity programs at home .
METHODS	Basic clinical measures ( anthropometrics , blood pressure , aerobic fitness ) and blood panel for assessing cardiometabolic risk ( glucose , lipid profile ) were conducted at baseline ( week 0 ) and follow-up ( week 12 ) in a primary care office .
RESULTS	There were no differences between groups at baseline ( P > 0.05 ) .
RESULTS	The intervention changed clinical ( F , = 20.458 , P = 0.000 , P = 0.672 ) and blood panel measures ( F , = 4.576 , P = 0.002 , P = 0.314 ) of cardiometabolic health .
RESULTS	Post hoc analyses indicted no differences between groups ( P > 0.05 ) .
CONCLUSIONS	Physical activity prescription of various intensities through the primary care setting improved cardiometabolic health status .
CONCLUSIONS	To our knowledge , this is the first report of sedentary behavior prescription ( alone , or combined with exercise ) in primary care .
CONCLUSIONS	The findings support the ongoing practice of fitness assessment and physical activity prescription for chronic disease management and prevention .

###25062857
BACKGROUND	`` Practice effects '' ( PE ) , or performance improvements due to prior exposure to testing , are known to confound cognitive test results , particularly when short intervals occur between two test sessions .
OBJECTIVE	We examined two subsamples with short or long re-test intervals from a recent clinical trial .
METHODS	Thirty-four non-depressed adults with mild Huntington Disease ( HD ) participated .
METHODS	Three cognitive tests were administered at screening and again at baseline , before active treatment randomization .
METHODS	Half the sample had a 24-hour retest interval while the other half was > 6-days .
RESULTS	The two groups differed on demographic/clinical factors ( age , Total Motor Score and Total Functional Capacity ) .
RESULTS	After controlling for age and motor score , PE differences were found on three of the five UHDRS cognitive tests : the longer interval group showed larger PE on Symbol-Digit Modalities and Stroop color , while the rapid interval group had larger PE on Stroop interference .
RESULTS	Controlling for screening cognitive performance yielded similar results .
CONCLUSIONS	Length of interval between screening and baseline visits and level of disease severity may influence stability of UHDRS cognitive test results in clinical trials in HD .

###24726247
BACKGROUND	There is increasing evidence that vaccines have an effect on general mortality which goes beyond specific disease protection .
BACKGROUND	Oral polio vaccine ( OPV ) is widely used in low-income countries , but in observational studies in Guinea-Bissau we observed that not receiving OPV at birth was associated with reduced overall male infant mortality and enhanced immune response to BCG vaccine .
BACKGROUND	We therefore initiated a randomized trial to test the overall effect of OPV at birth ( OPV0 ) .
OBJECTIVE	A small thymic gland is a predictor of mortality in high-mortality settings .
OBJECTIVE	Within the trial we aimed to test whether no-OPV0 was associated with increased thymic size .
METHODS	In 511 normal birth weight infants who were randomized to receive or not receive OPV0 , thymic index and thymus/weight index were measured before randomization and after 2 weeks ( N = 49 ) , 4 weeks ( N = 308 ) or 6 weeks ( N = 27 ) .
METHODS	The association between OPV0 and the log transformed thymic size indicators were analyzed in ANCOVA models with thymic size at follow-up as the outcome and adjusting for thymic size at enrollment and age at follow-up .
METHODS	Estimates were reported as geometric mean ratios ( GMR ) with 95 % confidence intervals , comparing no-OPV0 to OPV0 .
RESULTS	No-OPV0 was not associated with thymic index after 2 weeks ( GMR : 1.14 ( 0.99-1 .30 ) ) , after 4 weeks ( GMR : 0.98 ( 0.93-1 .05 ) ) or after 6 weeks ( GMR : 1.00 ( 0.81-1 .23 ) ) .
RESULTS	However , no-OPV0 was associated with increased thymus/weight index after 2 weeks ( GMR : 1.22 ( 1.06-1 .40 ) ) , but the effect was not seen after 4 weeks ( GMR : 0.97 ( 0.92-1 .03 ) ) and 6 weeks ( GMR : 0.99 ( 0.82-1 .19 ) ) .
RESULTS	There were no strong sex-differences .
CONCLUSIONS	Overall there was no effect on thymic size of OPV0 when administered with BCG .
CONCLUSIONS	The results could indicate that if an effect occurs , it is only within the first weeks after vaccination .

###24527996
OBJECTIVE	This study investigated the influence of injury cause , contact-sport participation , and prior knowledge of mild traumatic brain injury ( mTBI ) on injury beliefs and chronic symptom expectations of mTBI .
METHODS	A total of 185 non-contact-sport players ( non-CSPs ) and 59 contact-sport players ( CSPs ) with no history of mTBI were randomly allocated to one of two conditions in which they read either a vignette depicting a sport-related mTBI ( mTBIsport ) or a motor-vehicle-accident-related mTBI ( mTBIMVA ) .
METHODS	The vignettes were otherwise standardized to convey the same injury parameters ( e.g. , duration of loss of consciousness ) .
METHODS	After reading a vignette , participants reported their injury beliefs ( i.e. , perceptions of injury undesirability , chronicity , and consequences ) and their expectations of chronic postconcussion syndrome ( PCS ) and posttraumatic stress disorder ( PTSD ) symptoms .
RESULTS	Non-CSPs held significantly more negative beliefs and expected greater PTSD symptomatology and greater PCS affective symptomatology from an mTBIMVA vignette thann mTBIsport vignette , but this difference was not found for CSPs .
RESULTS	Unlike CSPs , non-CSPs who personally knew someone who had sustained an mTBI expected significantly less PCS symptomatology than those who did not .
RESULTS	Despite these different results for non-CSPs and CSPs , overall , contact-sport participation did not significantly affect injury beliefs and symptom expectations from an mTBIsport .
CONCLUSIONS	Expectations of persistent problems after an mTBI are influenced by factors such as injury cause even when injury parameters are held constant .
CONCLUSIONS	Personal knowledge of mTBI , but not contact sport participation , may account for some variability in mTBI beliefs and expectations .
CONCLUSIONS	These factors require consideration when assessing mTBI outcome .

###25726404
BACKGROUND	Previous research has demonstrated that current methods of informed consent are relatively ineffective as shown by poor recall and comprehension by adolescent patients and their parents .
BACKGROUND	The purpose of this study was to determine whether adding a short videotape presentation reiterating the issues related to informed consent to a modified informed consent document that emphasizes a limited number of core and patient-specific custom `` chunks '' at the beginning of an informed consent presentation improved the recall and comprehension of the risks , benefits , and alternatives of orthodontic treatment .
BACKGROUND	A second objective was to evaluate the current related data for recommendable practices .
METHODS	Seventy patient-parent pairs were randomly divided into 2 groups .
METHODS	The intervention group ( group A ) patients and parents together reviewed a customized slide show and a short videotape presentation describing the key risks of orthodontic treatment .
METHODS	Group B followed the same protocol without viewing the videotape .
METHODS	All patients and parents were interviewed independently by research assistants using an established measurement tool with open-ended questions .
METHODS	Interviews were transcribed and scored for the appropriateness of responses using a previously established codebook .
METHODS	Lastly , the patients and parents were given 2 reading literacy tests , 1 related to health and 1 with general content followed by the self-administered demographic and psychological state questionnaires .
RESULTS	There were no significant differences between the groups for sociodemographic variables .
RESULTS	There were no significant differences between the groups for overall recall and comprehension ; recall and comprehension for the domains of treatment , risk , and responsibility ; and recall and comprehension for core , general , and custom items .
RESULTS	The positional effects were limited in impact .
RESULTS	When compared with previous studies , these data further demonstrate the benefit of improved readability and audiovisual supplementation with the addition of `` chunking . ''
CONCLUSIONS	There is no benefit to adding a short video to the previously established improved readability and audiovisual supplementation .
CONCLUSIONS	There is a significant benefit of improved readability and audiovisual slide supplementation with the addition of `` chunking '' over traditional informed consent methods in terms of patient improvement in overall comprehension , treatment recall , and treatment comprehension .
CONCLUSIONS	The treatment domain is the most affected .

###25311446
BACKGROUND	War-related trauma , posttraumatic stress disorder ( PTSD ) , depression and suicide are common in US military members .
BACKGROUND	Often , those affected do not seek treatment due to stigma and barriers to care .
BACKGROUND	When care is sought , it often fails to meet quality standards .
BACKGROUND	A randomized trial is assessing whether collaborative primary care improves quality and outcomes of PTSD and depression care in the US military health system .
OBJECTIVE	The aim of this study is to describe the design and sample for a randomized effectiveness trial of collaborative care for PTSD and depression in military members attending primary care .
METHODS	The STEPS-UP Trial ( STepped Enhancement of PTSD Services Using Primary Care ) is a 6 installation ( 18 clinic ) randomized effectiveness trial in the US military health system .
METHODS	Study rationale , design , enrollment and sample characteristics are summarized .
RESULTS	Military members attending primary care with suspected PTSD , depression or both were referred to care management and recruited for the trial ( 2592 ) , and 1041 gave permission to contact for research participation .
RESULTS	Of those , 666 ( 64 % ) met eligibility criteria , completed baseline assessments , and were randomized to 12 months of usual collaborative primary care versus STEPS-UP collaborative care .
RESULTS	Implementation was locally managed for usual collaborative care and centrally managed for STEPS-UP .
RESULTS	Research reassessments occurred at 3 - , 6 - , and 12-months .
RESULTS	Baseline characteristics were similar across the two intervention groups .
CONCLUSIONS	STEPS-UP will be the first large scale randomized effectiveness trial completed in the US military health system , assessing how an implementation model affects collaborative care impact on mental health outcomes .
CONCLUSIONS	It promises lessons for health system change .

###24923533
BACKGROUND	Survival is poorer in elderly patients with head and neck squamous cell carcinomas [ HNSCCs ] than in younger patients .
BACKGROUND	Possible explanations include a contribution of co-morbidities to mortality , frequent refusal of standard therapy , and the use of suboptimal treatments due to concern about toxicities .
BACKGROUND	The Comprehensive Geriatric Assessment [ CGA ] is a multidimensional assessment of general health that can help to customise treatment and follow-up plans .
BACKGROUND	The CGA has been proven effective in several health settings but has not been evaluated in randomised studies of patients with cancer .
BACKGROUND	Our aim here was to assess the impact of the CGA on overall survival , function , and nutritional status of elderly patients with HNSCC .
METHODS	EGeSOR is an open-label , multicentre , randomised , controlled , parallel-group trial in patients aged 70 years or older and receiving standard care for HNSCC .
METHODS	The intervention includes four components : the CGA conducted by a geriatrician before cancer treatment , participation of the same geriatrician in cancer treatment selection , a standardised geriatric therapeutic intervention designed by the same geriatrician ; and geriatric follow-up for 24 months .
METHODS	The primary endpoint , assessed after 6 months , is a composite criterion including death , functional impairment [ Activities of Daily Living score decrease 2 ] , and weight loss 10 % .
METHODS	Secondary endpoints include progression-free survival , unscheduled admissions , quality of life , treatment toxicities , costs , and completion of the planned cancer treatment .
METHODS	A centralised online system is used to perform 1:1 randomisation with a minimisation algorithm for centre , age , T and N stages , and tumour site [ oral , oropharyngeal , hypopharyngeal , or laryngeal ] .
METHODS	The estimated sample size is 704 patients , who are being recruited by 14 centres in 9 French cities .
CONCLUSIONS	EGeSOR is the first randomised trial of the CGA in elderly cancer patients .
CONCLUSIONS	We expect the CGA to have direct clinical benefits on the management of elderly patients with HNSCC .
CONCLUSIONS	If this expectation is fulfilled , the trial may lead to modifications of the management model for elderly patients with cancer .
BACKGROUND	Trial registration : NCT02025062 .

###26206644
BACKGROUND	Laparoscopic ventral hernia repair ( LVHR ) is associated with considerable postoperative pain .
BACKGROUND	Transversus abdominis plane ( TAP ) blocks have proven effective in controlling postoperative pain in a variety of laparoscopic abdominal operations .
BACKGROUND	To date , no studies have focused on TAP blocks in LVHR .
BACKGROUND	Our goal was to assess whether TAP blocks reduce opioid requirements and pain scores after LVHR .
METHODS	Patients undergoing LVHR were randomly assigned to receive a TAP block or placebo injection .
METHODS	The primary end points were cumulative opioid use at 1 , 3 , 6 , 12 , 18 , and 24 hours postoperatively and pain scores recorded at 1 and 24 hours postoperatively .
RESULTS	Patients in the experimental TAP group ( n = 52 ) and control group ( n = 48 ) were comparable with respect to patient demographics and clinical characteristics .
RESULTS	In the postanesthesia care unit , the TAP group had significantly lower pain scores than the control group ( p < 0.05 ) .
RESULTS	Patients in the TAP group used less opioids than the control group at each time point assessed after 6 hours postoperatively ( p < 0.05 ) .
RESULTS	There was no significant difference in pain scores at 24 hours postoperatively ( p > 0.05 ) .
CONCLUSIONS	Transversus abdominis plane blocks given during LVHR significantly decrease both short-term postoperative opioid use and pain experienced by patients .

###25645425
OBJECTIVE	Research conducted with adults suggests that successful weight losers demonstrate greater activation in brain regions associated with executive control in response to viewing high-energy foods .
OBJECTIVE	No previous studies have examined these associations in adolescents .
OBJECTIVE	Functional neuroimaging was used to assess brain response to food images among groups of overweight ( OW ) , normal-weight ( NW ) , and successful weight-losing ( SWL ) adolescents .
METHODS	Eleven SWL , 12 NW , and 11 OW participants underwent functional magnetic resonance imaging while viewing images of high - and low-energy foods .
RESULTS	When viewing high-energy food images , SWLs demonstrated greater activation in the dorsolateral prefrontal cortex ( DLPFC ) compared with OW and NW controls .
RESULTS	Compared with NW and SWL groups , OW individuals demonstrated greater activation in the ventral striatum and anterior cingulate in response to food images .
CONCLUSIONS	Adolescent SWLs demonstrated greater neural activation in the DLPFC compared with OW/NW controls when viewing high-energy food stimuli , which may indicate enhanced executive control .
CONCLUSIONS	OW individuals ' brain responses to food stimuli may indicate greater reward incentive processes than either SWL or NW groups .

###25417983
BACKGROUND	The integration of simulation into the training of health care professionals provides context for decision making and procedural skills in a high-fidelity environment , without risk to actual patients .
BACKGROUND	It was hypothesised that a novel approach to simulation-based education - error management training - would produce higher performance ratings compared with traditional step-by-step instruction .
METHODS	Radiology technology students were randomly assigned to participate in traditional procedural-based instruction ( n = 11 ) or vicarious error management training ( n = 11 ) .
METHODS	All watched an instructional video and discussed how well each incident was handled ( traditional instruction group ) or identified where the errors were made ( vicarious error management training ) .
METHODS	Students then participated in a 30-minute case-based simulation .
METHODS	Simulations were videotaped for performance analysis .
METHODS	Blinded experts evaluated performance using a predefined evaluation tool created specifically for the scenario .
METHODS	Blinded experts evaluated performance using a predefined evaluation toolcreated specifically for the scenario
RESULTS	The vicarious error management group scored higher on observer-rated performance ( Mean = 9.49 ) than students in the traditional instruction group ( Mean = 9.02 ; p < 0.01 ) .
CONCLUSIONS	These findings suggest that incorporating the discussion of errors and how to handle errors during the learning session will better equip students when performing hands-on procedures and skills .
CONCLUSIONS	This pilot study provides preliminary evidence for integrating error management skills into medical curricula and for the design of learning goals in simulation-based education .

###24985574
BACKGROUND	Dry eye is a multifactorial disease of the tears and the ocular surface .
BACKGROUND	This study aimed to investigate the clinical efficacy of a non-steroidal anti-inflammatory drug , pranoprofen , in the treatment of dry eye .
METHODS	It is a prospective , multi-center , randomized , controlled , parallel group study .
METHODS	One hundred and fifteen patients with mild to moderate dry eye disease ( 55-60 in each treatment group ) participated in this multi-center study .
METHODS	Patients were randomly administered with eyedrops containing 0.1 % pranoprofen ( PRA ) plus 0.1 % sodium hyaluronate ( SH ) or SH only , three times daily for 28 days , followed by a 1-week after treatment observation .
METHODS	Dry eye symptom score ( DESS ) , fluorescein corneal staining ( FLCS ) , tear break-up time ( TBUT ) , and Shirmer 1 tear test ( ST1 , without anesthesia ) were evaluated or conducted before treatment and at each study visit .
METHODS	Conjunctival impression cytology was taken from the patients treated with PRA plus SH before and after treatment and real-time polymerase chain reaction ( RT-PCR ) was performed to detect the changes of human leukocyte antigen DR ( HLA-DR ) and intercellular adhesion molecule 1 ( ICAM-1 ) .
RESULTS	Patients treated with PRA plus SH showed gradual improvements of DESS , FLCS , and TBUT .
RESULTS	Between-group comparisons of FLCS and TBUT have statistically significant differences from day 14 .
RESULTS	Good tolerance with no severe adverse events was found in both groups .
RESULTS	Patients treated with PRA plus SH had a reduced expression level of HLA-DR and were statistically different after 28 days of therapy .
CONCLUSIONS	The application of PRA at a dose of 0.1 % was well tolerated and benefited to the patients with mild to moderate dry eye disease .
CONCLUSIONS	The underlying mechanism of its efficacy may be associated with the reduction of inflammatory factors of conjunctival epithelial cells .

###24248687
OBJECTIVE	We investigated the pattern of rash , diarrhea , and hepatic adverse events ( AEs ) secondary to lapatinib and their association with age and pathologic complete response ( pCR ) in the Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation ( NeoALLTO ) phase III trial .
METHODS	Patients with HER2-positive early breast cancer were randomly assigned to receive lapatinib ( Arm A ) , trastuzumab ( Arm B ) , or their combination ( Arm C ) for 6 weeks followed by the addition of paclitaxel for 12 weeks before surgery .
METHODS	We investigated the frequency and time to developing each AE according to age ( 50 v > 50 years ) and their association with pCR in a logistic regression model adjusted for age , hormone receptors , tumor size , nodal status , planned breast surgery , completion of lapatinib administration , and treatment arm .
RESULTS	Only patients randomly assigned to arms A and C were eligible ( n = 306 ) .
RESULTS	Younger patients ( 50 years ) experienced significantly more rash compared with older patients ( 74.4 % v 47.9 % ; P < .0001 ) .
RESULTS	Diarrhea and hepatic AEs were observed in 78.8 % and 41.2 % of patients , respectively , with no differences in rate or severity or time of onset according to age .
RESULTS	Early rash ( ie , before starting paclitaxel ) was independently associated with a higher chance of pCR , mainly in patients older than 50 years ( odds ratio [ OR ] = 3.76 ; 95 % CI , 1.69 to 8.34 ) but not in those 50 years ( OR = 0.92 ; 95 % CI , 0.45 to 1.88 ; P for interaction = .01 ) .
RESULTS	No significant association was observed between pCR and diarrhea or hepatic AEs .
CONCLUSIONS	Our results indicate that the frequency and clinical relevance of lapatinib-related rash is largely dependent on patient age .

###25581656
BACKGROUND	We examined whether the effects of topiramate and a single nucleotide polymorphism ( rs2832407 ) in GRIK1 , which encodes a kainate receptor subunit , persisted following a 12-week , placebo-controlled trial in 138 heavy drinkers with a treatment goal of reduced drinking .
BACKGROUND	During treatment , topiramate 200mg/d significantly reduced heavy drinking days and increased the frequency of abstinent days ( Am J Psychiatry , 2014 , 171:445 ) .
BACKGROUND	In the European-American ( EA ) subsample ( n = 122 ) , rs2832407 moderated the treatment effect on heavy drinking .
METHODS	Patients were re-interviewed 3 and 6months after the end of treatment .
METHODS	During treatment , we obtained 92.4 % of drinking data , with 89.1 and 85.5 % complete data at the 3 - and 6-month follow-up visits , respectively .
METHODS	We examined 4 outcomes over time in the overall sample and the EA subsample : percent heavy drinking days ( PHDD ) , percent days abstinent ( PDA ) , serum - glutamyl transpeptidase ( GGTP ) concentration , and a measure of alcohol-related problems .
RESULTS	In the full sample , the lower PHDD and higher PDA seen with topiramate treatment were no longer significant during follow-up .
RESULTS	Nonetheless , the topiramate-treated patients had lower alcohol-related problem scores during treatment and both follow-up periods .
RESULTS	Further , in the EA subsample , the greater reduction in PHDD seen with topiramate treatment in rs2832407 * C-allele homozygotes persisted throughout follow-up , with no significant effects in A-allele carriers .
RESULTS	A reduction in GGTP concentration was consistent with the reduction in heavy drinking , but did not reach statistical significance .
CONCLUSIONS	There are persistent therapeutic effects of topiramate in heavy drinkers , principally in rs2832407 * C-allele homozygotes .

###24656314
OBJECTIVE	We introduce a new method of peritoneal dialysis ( PD ) catheter placement with cystoscopic assistance .
OBJECTIVE	It has clear advantages compared with conventional open surgery .
METHODS	Patients with end-stage renal disease ( ESRD ) were randomly divided into two groups .
METHODS	Group A ( 14 patients ) underwent cystoscopy-assisted surgery , and group B ( 15 patients ) underwent conventional open surgery for the PD catheter placement .
METHODS	Continuous ambulatory PD training was started 14 days after surgery in both groups .
METHODS	We evaluated the differences between the two groups prospectively .
RESULTS	Both groups had no difference in demographics including age , male/female ratio , previous abdominal surgery percent , and cause of ESRD ( p > 0.05 ) .
RESULTS	All catheters were placed successfully without mortality .
RESULTS	Group A had better surgery-related data : local anesthesia rate , VAS ( Visual Analogue Score ) , incisional length , and hospital stay were significantly different compared with group B ( p < 0.05 ) .
RESULTS	And the blood loss duration surgery and duration of surgery were not significantly different ( p > 0.05 ) .
RESULTS	In group A , there was no case of catheter obstruction and migration , dialysate leak , exit site infection , or incisional hernia .
RESULTS	There was only one peritonitis case in group A. Compared with group B , the total surgical complications difference was significant ( p < 0.05 ) .
CONCLUSIONS	Cystoscopy-assisted PD catheter placement is a direct , visual , safe , precise , easy , inexpensive , and minimally invasive technique that is ideal for patients with ESRD .

###25862517
BACKGROUND	The optimum duration of first-line treatment with chemotherapy in combination with bevacizumab in patients with metastatic colorectal cancer is unknown .
BACKGROUND	The CAIRO3 study was designed to determine the efficacy of maintenance treatment with capecitabine plus bevacizumab versus observation .
METHODS	In this open-label , phase 3 , randomised controlled trial , we recruited patients in 64 hospitals in the Netherlands .
METHODS	We included patients older than 18 years with previously untreated metastatic colorectal cancer , with stable disease or better after induction treatment with six 3-weekly cycles of capecitabine , oxaliplatin , and bevacizumab ( CAPOX-B ) , WHO performance status of 0 or 1 , and adequate bone marrow , liver , and renal function .
METHODS	Patients were randomly assigned ( 1:1 ) to either maintenance treatment with capecitabine and bevacizumab ( maintenance group ) or observation ( observation group ) .
METHODS	Randomisation was done centrally by minimisation , with stratification according to previous adjuvant chemotherapy , response to induction treatment , WHO performance status , serum lactate dehydrogenase concentration , and treatment centre .
METHODS	Both patients and investigators were aware of treatment assignment .
METHODS	We assessed disease status every 9 weeks .
METHODS	On first progression ( defined as PFS1 ) , patients in both groups were to receive the induction regimen of CAPOX-B until second progression ( PFS2 ) , which was the study 's primary endpoint .
METHODS	All endpoints were calculated from the time of randomisation .
METHODS	Analyses were done by intention to treat .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00442637 .
RESULTS	Between May 30 , 2007 , and Oct 15 , 2012 , we randomly assigned 558 patients to either the maintenance group ( n = 279 ) or the observation group ( n = 279 ) .
RESULTS	Median follow-up was 48 months ( IQR 36-57 ) .
RESULTS	The primary endpoint of median PFS2 was significantly improved in patients on maintenance treatment , and was 85 months in the observation group and 117 months in the maintenance group ( HR 067 , 95 % CI 056-081 , p < 00001 ) .
RESULTS	This difference remained significant when any treatment after PFS1 was considered .
RESULTS	Maintenance treatment was well tolerated , although the incidence of hand-foot syndrome was increased ( 64 [ 23 % ] patients with hand-foot skin reaction during maintenance ) .
RESULTS	The global quality of life did not deteriorate during maintenance treatment and was clinically not different between treatment groups .
CONCLUSIONS	Maintenance treatment with capecitabine plus bevacizumab after six cycles of CAPOX-B in patients with metastatic colorectal cancer is effective and does not compromise quality of life .
BACKGROUND	Dutch Colorectal Cancer Group ( DCCG ) .
BACKGROUND	The DCCG received financial support for the study from the Commissie Klinische Studies ( CKS ) of the Dutch Cancer Foundation ( KWF ) , Roche , and Sanofi-Aventis .

###25835472
BACKGROUND	Self-guided , Web-based interventions for depression show promising results but suffer from high attrition and low user engagement .
BACKGROUND	Online peer support networks can be highly engaging , but they show mixed results and lack evidence-based content .
OBJECTIVE	Our aim was to introduce and evaluate a novel Web-based , peer-to-peer cognitive reappraisal platform designed to promote evidence-based techniques , with the hypotheses that ( 1 ) repeated use of the platform increases reappraisal and reduces depression and ( 2 ) that the social , crowdsourced interactions enhance engagement .
METHODS	Participants aged 18-35 were recruited online and were randomly assigned to the treatment group , `` Panoply '' ( n = 84 ) , or an active control group , online expressive writing ( n = 82 ) .
METHODS	Both are fully automated Web-based platforms .
METHODS	Participants were asked to use their assigned platform for a minimum of 25 minutes per week for 3 weeks .
METHODS	Both platforms involved posting descriptions of stressful thoughts and situations .
METHODS	Participants on the Panoply platform additionally received crowdsourced reappraisal support immediately after submitting a post ( median response time = 9 minutes ) .
METHODS	Panoply participants could also practice reappraising stressful situations submitted by other users .
METHODS	Online questionnaires administered at baseline and 3 weeks assessed depression symptoms , reappraisal , and perseverative thinking .
METHODS	Engagement was assessed through self-report measures , session data , and activity levels .
RESULTS	The Panoply platform produced significant improvements from pre to post for depression ( P = .001 ) , reappraisal ( P < .001 ) , and perseverative thinking ( P < .001 ) .
RESULTS	The expressive writing platform yielded significant pre to post improvements for depression ( P = .02 ) and perseverative thinking ( P < .001 ) , but not reappraisal ( P = .45 ) .
RESULTS	The two groups did not diverge significantly at post-test on measures of depression or perseverative thinking , though Panoply users had significantly higher reappraisal scores ( P = .02 ) than expressive writing .
RESULTS	We also found significant group by treatment interactions .
RESULTS	Individuals with elevated depression symptoms showed greater comparative benefit from Panoply for depression ( P = .02 ) and perseverative thinking ( P = .008 ) .
RESULTS	Individuals with baseline reappraisal deficits showed greater comparative benefit from Panoply for depression ( P = .002 ) and perseverative thinking ( P = .002 ) .
RESULTS	Changes in reappraisal mediated the effects of Panoply , but not the expressive writing platform , for both outcomes of depression ( ab = -1.04 , SE 0.58 , 95 % CI -2.67 to -.12 ) and perseverative thinking ( ab = -1.02 , SE 0.61 , 95 % CI -2.88 to -.20 ) .
RESULTS	Dropout rates were similar for the two platforms ; however , Panoply yielded significantly more usage activity ( P < .001 ) and significantly greater user experience scores ( P < .001 ) .
CONCLUSIONS	Panoply engaged its users and was especially helpful for depressed individuals and for those who might ordinarily underutilize reappraisal techniques .
CONCLUSIONS	Further investigation is needed to examine the long-term effects of such a platform and whether the benefits generalize to a more diverse population of users .
BACKGROUND	ClinicalTrials.gov NCT02302248 ; https://clinicaltrials.gov/ct2/show/NCT02302248 ( Archived by WebCite at http://www.webcitation.org/6Wtkj6CXU ) .

###25677337
BACKGROUND	To improve patient health , recent research urges for medical decision aids that are designed to enhance the effectiveness of specific medically related decisions .
BACKGROUND	Many such decisions involve complex information , and decision aids that independently use deliberative ( analytical and slower ) or intuitive ( more affective and automatic ) cognitive processes for such decisions result in suboptimal decisions .
BACKGROUND	Unconscious thought can arguably use both intuitive and deliberative ( slow and analytic ) processes , and this combination may further benefit complex patient ( or practitioner ) decisions as medical decision aids .
BACKGROUND	Indeed , mounting research demonstrates that individuals render better decisions generally if they are distracted from thinking consciously about complex information after it is presented ( but can think unconsciously ) , relative to thinking about that information consciously or not at all .
OBJECTIVE	The current research tested whether the benefits of unconscious thought processes can be replicated using an Internet platform for a patient medical decision involving complex information .
OBJECTIVE	This research also explored the possibility that judgments reported after a period of unconscious thought are actually the result of a short period of conscious deliberation occurring during the decision report phase .
METHODS	A total of 173 participants in a Web-based experiment received information about four medical treatments , the best ( worst ) associated with mostly positive ( negative ) side-effects/attributes and the others with equal positive-negative ratios .
METHODS	Next , participants were either distracted for 3 minutes ( unconscious thought ) , instructed to think about the information for 3 minutes ( conscious thought ) , or moved directly to the decision task ( immediate decision ) .
METHODS	Finally , participants reported their choice of , and attitudes toward , the treatments while experiencing high , low , or no cognitive load , which varied their ability to think consciously while reporting judgments .
METHODS	Cognitive load was manipulated by having participants memorize semi-random ( high ) , line structured ( low ) , or no dot patterns and recall these intermittently with their decision reports .
METHODS	Overall then , participants were randomly assigned to the conditions of a 3 ( thought condition ) by 3 ( cognitive-load level ) between-subjects design .
RESULTS	A logistic regression analysis indicated that the odds of participants choosing the best treatment were 2.25 times higher in the unconscious-thought condition compared to the immediate-decision condition ( b = .81 , Wald = 4.32 , P = .04 , 95 % CI 1.048-4 .836 ) , and 2.39 times greater compared to the conscious-thought condition ( b = .87 , Wald = 4.87 , P = .027 , 95 % CI 1.103-5 .186 ) .
RESULTS	No difference was observed between the conscious-thought condition compared to the immediate-decision condition , and cognitive load manipulations did not affect choices or alter the above finding .
CONCLUSIONS	This research demonstrates a plausible benefit of unconscious thinking as a decision aid for complex medical decisions , and represents the first use of unconscious thought processes as a patient-centered medical decision aid .
CONCLUSIONS	Further , the quality of decisions reached unconsciously does not appear to be affected by the amount of cognitive load participants experienced .

###24998106
OBJECTIVE	the medications used according to the recommendation of the World Health Organization do not promote pain relief in a number of patients with cancer pain .
OBJECTIVE	The aim of this study was to evaluate the use of morphine as first medication for the treatment of moderate cancer pain in patients with advanced and/or metastatic disease , as an option to the recommendations of the World Health Organization analgesic ladder .
METHODS	sixty patients without opioid therapy , with 18 years of age , were randomized into two groups .
METHODS	G1 patients received medication according to the analgesic ladder and started treatment with non-opioids in the first , weak opioids in the second , and strong opioids in the third step ; G2 patients received morphine as first analgesic medication .
METHODS	The efficacy and tolerability of initial use of morphine were evaluated every two weeks for three months .
RESULTS	the groups were similar with respect to demographic data .
RESULTS	There was no significant difference between the groups regarding pain intensity , quality of life , physical capacity , satisfaction with treatment , need for complementation and dose of morphine .
RESULTS	In G1 there was a higher incidence of nausea ( p = 0.0088 ) , drowsiness ( p = 0.0005 ) , constipation ( p = 0.0071 ) and dizziness ( p = 0.0376 ) in the second visit and drowsiness ( p = 0.05 ) in the third .
CONCLUSIONS	the use of morphine as first medication for pain treatment did not promote better analgesic effect than the ladder recommended by World Health Organization , with higher incidence of adverse effects .

###24825167
OBJECTIVE	Simplification of antiretroviral therapy in patients with suppressed viremia may minimize long-term adverse effects .
OBJECTIVE	The study 's primary objective was to determine whether abacavir/lamivudine + atazanavir ( ABC/3TC + ATV ) was virologically non-inferior to tenofovir/emtricitabine + atazanavir/ritonavir ( TDF/FTC + ATV/r ) over 24 weeks in a population of virologically suppressed , HIV-1 infected patients .
METHODS	This open-label , multicenter , non-inferiority study enrolled antiretroviral experienced , HIV-infected adults currently receiving a regimen of TDF/FTC + ATV/r for 6 months with no history of virologic failure and whose HIV-1 RNA had been 75 copies/mL on 2 consecutive measurements including screening .
METHODS	Patients were randomized 1 2 to continue current treatment or simplify to ABC/3TC + ATV .
METHODS	The primary endpoint was the proportion of patients with HIV-RNA < 50 copies/mL at Week 24 by the Time to Loss of Virologic Response ( TLOVR ) algorithm .
METHODS	Secondary endpoints included alternative measures of efficacy , adverse events ( AEs ) , and fasting lipids .
METHODS	Exploratory endpoints included inflammatory , coagulation , bone , and renal biomarkers .
RESULTS	After 24 weeks , ABC/3TC + ATV ( n = 199 ) was non-inferior to TDF/FTC + ATV/r ( n = 97 ) by both the primary analysis ( 87 % in both groups ) and all secondary efficacy analyses .
RESULTS	Rates of grade 2-4 AEs were similar between the two groups ( 40 % vs 37 % , respectively ) , but an excess of hyperbilirubinemia made the rate of grade 3-4 laboratory abnormalities higher in the TDF/FTC + ATV/r group ( 30 % ) compared with the ABC/3TC + ATV group ( 13 % ) .
RESULTS	Lipid levels were stable except for HDL cholesterol , which increased significantly in the ABC/3TC + ATV group .
RESULTS	Bone and renal biomarkers improved significantly between baseline and Week 24 in patients taking ABC/3TC + ATV , and the difference between groups was significant at Week 24 .
RESULTS	No significant changes occurred in any inflammatory or coagulation biomarker within or between treatment groups .
CONCLUSIONS	After 24 weeks , simplification to ABC/3TC + ATV from TDF/FTC + ATV/r maintained viral suppression was well-tolerated , and led to improvements in bone and renal biomarkers and HDL cholesterol .
BACKGROUND	ClinicalTrials.gov NCT01102972 GlaxoSmithKline Clinical Study Register # 113734 .

###24886151
BACKGROUND	Increased life expectancy has resulted in a greater provision of informal care within the community for patients with chronic physical health conditions .
BACKGROUND	Informal carers are at greater risk of poor mental health , with one in three informal carers of stroke survivors experiencing depression .
BACKGROUND	However , currently no psychological treatments tailored to the unique needs of depressed informal carers of stroke survivors exist .
BACKGROUND	Furthermore , informal carers of stroke survivors experience a number of barriers to attending traditional face-to-face psychological services , such as lack of time and the demands of the caring role .
BACKGROUND	The increased flexibility associated with supported cognitive behavioral therapy self-help ( CBTsh ) , such as the ability for support to be provided by telephone , email , or face-to-face , alongside shorter support sessions , may help overcome such barriers to access .
BACKGROUND	CBTsh , tailored to depressed informal carers of stroke survivors may represent an effective and acceptable solution .
METHODS	This study is a Phase II ( feasibility ) randomized controlled trial ( RCT ) following guidance in the MRC Complex Interventions Research Methods Framework .
METHODS	We will randomize a sample of depressed informal carers of stroke survivors to receive CBT self-help supported by mental health paraprofessionals , or treatment-as-usual .
METHODS	Consistent with the objectives of assessing the feasibility of trial design and procedures for a potential larger scale trial we will measure the following outcomes : a ) feasibility of patient recruitment ( recruitment and refusal rates ) ; ( b ) feasibility and acceptability of data collection procedures ; ( c ) levels of attrition ; ( d ) likely intervention effect size ; ( e ) variability in number , length and frequency of support sessions estimated to bring about recovery ; and ( f ) acceptability of the intervention .
METHODS	Additionally , we will collect data on the diagnosis of depression , symptoms of depression and anxiety , functional impairment , carer burden , quality of life , and stroke survivor mobility skill , self-care and functional ability , measured at four and six months post-randomization .
CONCLUSIONS	This study will provide important information for the feasibility and design of a Phase III ( effectiveness ) trial in the future .
CONCLUSIONS	If the intervention is identified to be feasible , effective , and acceptable , a written CBTsh intervention for informal carers of stroke survivors , supported by mental health paraprofessionals , could represent a cost-effective model of care .
BACKGROUND	Current Controlled Trials ISRCTN63590486 .

###25197921
BACKGROUND	The purpose of this study was to investigate the effect of aerosolized fibrin sealant ( FS ) compared with that of polyvinyl acetal sponge packing on hemostasis and wound healing after functional endoscopic sinus surgery ( FESS ) .
METHODS	We conducted a prospective randomized controlled trial of the use of aerosolized FS in 41 consecutive patients who underwent bilateral FESS between February 2011 and March 2012 .
METHODS	The patients were randomized to receive FS applied via an aerosol spray in one nasal cavity and polyvinyl acetal sponge packing in the opposite cavity .
METHODS	The patients were followed up at 1 , 2 , 4 , 8 , and 12 weeks postoperatively .
METHODS	Crusting , adhesion , bleeding , granulation tissue formation , infection , and frontal sinus ostium stenosis after endoscopic surgery were assessed using a grading scale .
METHODS	Subjective symptoms related to nasal packing were evaluated using questionnaires quantified by visual analog scales .
RESULTS	The degree of granulation and crusting was significantly reduced in the side treated with FS compared with the polyvinyl acetal sponge side , as were bleeding and pain during nasal packing removal ( p < 0.05 ) .
RESULTS	In addition , general satisfaction and willingness to reuse the material were significantly higher for the FS-treated side than for the polyvinyl acetal sponge-packed side ( p < 0.001 ) .
CONCLUSIONS	Compared with polyvinyl acetal sponge , aerosolized FS shows beneficial effects on hemostasis and wound healing after FESS .
CONCLUSIONS	The application of FS resulted in a high degree of patient satisfaction without additional morbidity .

###25140908
OBJECTIVE	People infected with the human immunodeficiency virus are at an increased risk of developing ischemic heart disease ( IHD ) ; however , the effects of an education and home-based pedometer walking program on risk factors of IHD are not known .
METHODS	We conducted a 12-month randomized study of an education and home-based pedometer walking program in 84 human immunodeficiency virus-infected individuals with risk factors of IHD .
RESULTS	Pedometer step count of the control and intervention groups improved significantly ( P = 0.03 for both groups ) at 6 months but was not significant at 12 months ( P = 0.33 and 0.21 , respectively ) .
RESULTS	Significant between-group effects were observed in 6-minute walk test distance ( P = 0.01 ) , waist to hip ratio ( P = 0.00 ) , glucose ( P = 0.00 ) , and high-density lipoprotein ( P = 0.01 ) over the 12-month period .
RESULTS	The program did not result in change in high-sensitivity C-reactive protein as it was associated with perceived stress ( r = 0.23 ; P = 0.03 ) , weight ( r = 0.28 ; P = 0.01 ) , body mass index ( r = 0.35 ; P < 0.00 ) , waist ( r = 0.28 ; P = 0.01 ) and hip circumference ( r = 0.28 ; P = 0.01 ) .
RESULTS	Multivariate generalized estimation equation analysis demonstrated an inverse association between interaction and perceived stress ( logB = -0.01 ; 95 % confidence interval : -0.02 to -0.01 ; P < 0.00 ) and body mass index ( logB = -0.02 ; 95 % confidence interval : -0.03 to -0.002 ; P = 0.02 ) at group level .
CONCLUSIONS	An education and home-based pedometer walking program improves physical activity levels , and beneficial changes in other IHD risk factors were noted .

###24317176
BACKGROUND	At the time of the initial analysis of overall survival ( OS ) for the Comparison of Faslodex in Recurrent or Metastatic Breast Cancer ( CONFIRM ) randomized , double-blind , phase III trial , approximately 50 % of patients had died .
BACKGROUND	A final analysis of OS was subsequently planned for when 75 % of patients had died .
METHODS	Patients were randomly assigned 1:1 to fulvestrant 500 mg administered as two 5-mL intramuscular injections on days 0 , 14 , and 28 and every 28 ( 3 ) days thereafter or fulvestrant 250 mg administered as two 5-mL intramuscular injections ( one fulvestrant and one placebo [ identical in appearance to study drug ] ) on days 0 , 14 ( two placebo injections only ) , and 28 and every 28 ( 3 ) days thereafter .
METHODS	OS was analyzed using an unadjusted log-rank test .
METHODS	No adjustments were made for multiplicity .
METHODS	Serious adverse events ( SAEs ) and best response to subsequent therapy were also reported .
METHODS	All statistical tests were two-sided .
RESULTS	In total , 736 women ( median age = 61.0 years ) were randomly assigned to fulvestrant 500 mg ( n = 362 ) or 250 mg ( n = 374 ) .
RESULTS	At the final survival analysis , 554 of 736 ( 75.3 % ) patients had died .
RESULTS	Median OS was 26.4 months for fulvestrant 500 mg and 22.3 months for 250 mg ( hazard ratio = 0.81 ; 95 % confidence interval = 0.69-0 .96 ; nominal P = .02 ) .
RESULTS	There were no clinically important differences in SAE profiles between the treatment groups ; no clustering of SAEs could be detected in either treatment group .
RESULTS	Type of first subsequent therapy and objective responses to first subsequent therapy were well balanced between the two treatment groups .
CONCLUSIONS	In patients with locally advanced or metastatic estrogen receptor-positive breast cancer , fulvestrant 500 mg is associated with a 19 % reduction in risk of death and a 4.1-month difference in median OS compared with fulvestrant 250 mg .
CONCLUSIONS	Fulvestrant 500 mg was well tolerated , and no new safety concerns were identified .

###24880449
OBJECTIVE	The purpose of this study was to compare the use of amoxicillin ( 1g ) vs amoxicillin and clavulanate ( 875/125mg ) after extraction of retained third molars for prevention of infectious complications .
METHODS	The study involved 546 patients attending for removal a retained third molar and divided in to two groups : Group 1 - amoxicillin and clavunate ( 875/125mg ) group ( n = 257 ) and Group 2 - amoxicillin ( 1g ) group ( n = 289 ) .
METHODS	All patients were recalled for investigating the possibility of infection , presence of diarrhea and further analgesic intake .
RESULTS	From a total of 546 patients , the frequency of infection was 1.4 % , without no statistically differences between the two groups .
RESULTS	Group 1 showed statistically higher presence of patients with gastrointestinal complications ( p > 0.05 ) .
RESULTS	In 546 patients , 2.7 % of patients reported severe pain that would not relieve with medication .
CONCLUSIONS	The results of our study show that the use of amoxicillin ( 1g ) and amoxicillin and clavunate ( 875/125mg ) is similar efficacious in preventing infection after retained third molar extraction but amoxicillin and clavunate ( 875/125mg ) produces more gastrointestinal discomfort .

###24708570
BACKGROUND	The prevalence and consequences of musculoskeletal pain is considerable among healthcare workers , allegedly due to high physical work demands of healthcare work .
BACKGROUND	Previous investigations have shown promising results of physical exercise for relieving pain among different occupational groups , but the question remains whether such physical exercise should be performed at the workplace or conducted as home-based exercise .
BACKGROUND	Performing physical exercise at the workplace together with colleagues may be more motivating for some employees and thus increase adherence .
BACKGROUND	On the other hand , physical exercise performed during working hours at the workplace may be costly for the employers in terms of time spend .
BACKGROUND	Thus , it seems relevant to compare the efficacy of workplace - versus home-based training on musculoskeletal pain .
BACKGROUND	This study is intended to investigate the effect of workplace-based versus home-based physical exercise on musculoskeletal pain among healthcare workers .
METHODS	This study was designed as a cluster randomized controlled trial performed at 3 hospitals in Copenhagen , Denmark .
METHODS	Clusters are hospital departments and hospital units .
METHODS	Cluster randomization was chosen to increase adherence and avoid contamination between interventions .
METHODS	Two hundred healthcare workers from 18 departments located at three different hospitals is allocated to 10weeks of 1 ) workplace based physical exercise performed during working hours ( using kettlebells , elastic bands and exercise balls ) for 510minutes per week and up to 5 group-based coaching sessions , or 2 ) home based physical exercise performed during leisure time ( using elastic bands and body weight exercises ) for 510minutes per week .
METHODS	Both intervention groups will also receive ergonomic instructions on patient handling and use of lifting aides etc. .
METHODS	Inclusion criteria are female healthcare workers working at a hospital .
METHODS	Average pain intensity ( VAS scale 0-10 ) of the back , neck and shoulder ( primary outcome ) and physical exertion during work , social capital and work ability ( secondary outcomes ) is assessed at baseline and 10-week follow-up .
METHODS	Further , postural balance and mechanical muscle function is assessed during clinical examination at baseline and follow-up .
CONCLUSIONS	This cluster randomized trial will investigate the change in self-rated average pain intensity in the back , neck and shoulder after either 10 weeks of physical exercise at the workplace or at home .
BACKGROUND	ClinicalTrials.gov ( NCT01921764 ) .

###24841020
BACKGROUND	We compared the analgesic effects of caudal and ilioinguinal-iliohypogastric nerve block using bupivacaine-clonidine performed in children undergoing inguinal hernia repair .
BACKGROUND	The ilioinguinal-iliohypogastric nerve block provides excellent pain relief for operations on the inguinal region , including emergency procedures ( e.g. strangulated inguinal hernia with intestinal obstruction ) .
BACKGROUND	It should be preferred to caudal block for these procedures .
METHODS	After local ethics committee approval and written parental consent , 67 ASA class I - II patients aged between 2-7 years old scheduled for elective inguinal hernia repair were allocated randomly into two groups after general anesthesia with same drugs in both groups .
METHODS	Group C received caudal block with 1 ml/kg bupivacaine 0.25 % combined with 1 g/kg clonidine , and group I received ilioinguinal - iliohypogastric nerve block with 0.3 ml / kg bupivacaine 0.25 % combined with 1 g/kg clonidine .
METHODS	Blood pressure and heart rate were documented every 5 minutes .
METHODS	Post-operative analgesia , analgesic use and side-effects were assessed during first 24 hours .
RESULTS	In group C , 7 / 34 and in group I , 12/33 patients required post-operative analgesia ( P = 0.174 ) .
RESULTS	Five patients ( 15.5 % ) in group I and one patient ( 2.94 % ) in group C had severe pain after operation .
RESULTS	Systolic and diastolic blood pressure decreased during operation , but the differences between two groups were not significant ( P = 0.176 , P = 0.111 ) .
RESULTS	Heart rate changes between two groups were insignificant ( P = 0.182 ) .
CONCLUSIONS	It seems that in children , caudal epidural block and ilioinguinal - iliohypogastric nerve block using bupivacaine-clonidine have comparable effects on analgesia , severity of pain and hemodynamic changes during and after surgery on inguinal region .

###24507221
BACKGROUND	Work and being able to work are important prerequisites for health and well being .
BACKGROUND	Health problems can have a negative influence on the ability to work and not being able to work can be detrimental for patients ' psychosocial well being .
BACKGROUND	Although GPs are aware of this importance they do not always structurally pay attention to patients ' work during their daily practice .
METHODS	To investigate whether GPs can be trained to increase their awareness of work and improve their skills when dealing with work related problems we designed a cluster randomised controlled trial .
METHODS	The intervention in this trial is a tailored training based on the findings of qualitative research with focus groups of GPs .
METHODS	Gender aspects received specific attention in these focus groups .
METHODS	Primary outcome measures are self efficacy of patients concerning return to work , and GPs ' use of ICPC code Z05 ( work problems ) and registration of patients ' occupation .
METHODS	Secondary outcome measures are work awareness of GPs as perceived by patients , quality of life , health , use of care and illness related costs .
METHODS	A process evaluation will be part of our study .
CONCLUSIONS	We investigate a training to increase work awareness among GPs , improve their skills in managing work related problems and structurally register work related data in the EMR .
CONCLUSIONS	We think this study will make a contribution to better health care for workers by motivating GPs to appreciate their specific needs .
CONCLUSIONS	It will also add to our knowledge of the complex relationship between gender , work and health .

###24620855
BACKGROUND	Diabetes mellitus may be present in patients with cystic fibrosis starting in the second decade of life .
BACKGROUND	The prevalence increases rapidly with increasing age .
BACKGROUND	As life-expectancy increases in cystic fibrosis , cystic fibrosis related diabetes will be diagnosed more frequently in the future.Up to date , no data are available to answer the question if cystic fibrosis related diabetes should always initially be treated by insulin therapy .
BACKGROUND	Missing data regarding oral antidiabetic treatment of newly diagnosed cystic fibrosis related diabetes are an important reason to recommend insulin treatment .
BACKGROUND	Several centres report the successful management of cystic fibrosis related diabetes using oral anti-diabetic drugs at least for some years .
BACKGROUND	Oral therapies would be less invasive for a patient group which is highly traumatized by a very demanding therapy .
BACKGROUND	Based on an initiative of the German Mukoviszidosis-Foundation , the present study tries to answer the question , whether oral therapy with repaglinide is as effective as insulin therapy in cystic fibrosis patients with early diagnosed diabetes mellitus .
METHODS	In all cystic fibrosis patients with an age of 10 years or older , an oral glucose tolerance test is recommended .
METHODS	The result of this test is classified according to the WHO cut off values .
METHODS	It is required to have two diabetes positive oral glucose tolerance tests for the diagnosis of diabetes mellitus.This study is a multi-national , multicentre , open labelled , randomized and prospective controlled parallel group 's trial , with 24 months treatment.The primary objective of this trial is to compare the glycaemic control of oral therapy with Repaglinide with insulin injections in patients with cystic fibrosis related diabetes after 2 years of treatment.The trial should include 74 subjects showing cystic fibrosis related diabetes newly diagnosed by oral glucose tolerance test during annual screening for cystic fibrosis related diabetes.Patients are randomised by central fax randomisation.Primary endpoint is mean HbA1c after 24 months of treatment .
METHODS	Secondary endpoints are change in FEV1 % predicted and change in BMI-Z-score .
CONCLUSIONS	There is only one prospective study comparing oral antidiabetic drugs to insulin in the treatment of CFRD without fasting hyperglycaemia .
CONCLUSIONS	The results regarding BMI after 6 months and 12 months showed an improvement for the insulin treated patients and were inconsistent for those treated with repaglinide .
CONCLUSIONS	HbA1c and lung function ( FEV1 % pred ) were unchanged for either group .
CONCLUSIONS	The authors compared the changes -12 months to baseline and baseline to +12 months separately for each group .
CONCLUSIONS	Therefore a direct comparison of the effect of repaglinide versus insulin on BMI , HbA1c and FEV1 % pred was not presented .
CONCLUSIONS	According to our protocol , we will directly compare treatment effects ( HbA1c , BMI , FEV1 % pred ) in between both groups .
CONCLUSIONS	The actual Cochrane report regarding `` Insulin and oral agents for managing CFRD '' stated that further studies are needed to establish whether there is clear benefit for hypoglycemic agents .
CONCLUSIONS	We expect that the results of our study will help to address this clinical need .
BACKGROUND	ClinicalTrials.gov Identifier : NCT00662714 .

###24622806
BACKGROUND	Calcium from different dairy sources might affect blood lipids and fecal fat excretion differently because of differences in the food matrix and nutritional composition .
OBJECTIVE	We investigated whether milk - and cheese-based diets with similar calcium contents affect a saturated fatty acid-induced increase in blood lipids differently .
METHODS	Fifteen healthy , young men participated in a randomized 3 2-wk crossover study in which the following 3 isocaloric diets that were similar in fat contents and compositions were compared : control diet [ nondairy diet ( ~ 500 mg Ca/d ) ] , milk diet [ semiskimmed milk-based diet ( 1700 mg Ca/d ) ] , and cheese diet [ semihard cow-cheese-based diet ( 1700 mg Ca/d ) ] .
METHODS	Blood was drawn before and after each period , and feces were collected for 5 d during each period .
RESULTS	Saturated fatty acid-induced increases in total and low-density lipoprotein ( LDL ) cholesterol were lower with the milk diet ( mean SD : 0.57 0.13 and 0.53 0.11 mmol/L , respectively ) ( P < 0.01 ) and cheese diet ( 0.41 0.15 and 0.47 0.12 mmol/L , respectively ) ( P < 0.05 ) than with the control diet ( 0.89 0.12 and 0.84 0.11 mmol/L , respectively ) .
RESULTS	Fecal fat excretion increased more with the consumption of both the milk ( 5.2 0.4 g/d ) and cheese ( 5.7 0.4 g/d ) diets than with the control diet ( 3.9 0.3 g/d ) ( P < 0.001 ) .
RESULTS	Changes in blood pressure , high-density lipoprotein cholesterol , triglycerides , and lipid ratios did not differ .
CONCLUSIONS	Compared with the control diet , milk - and cheese-based diets attenuated saturated fatty acid-induced increases in total and LDL cholesterol and resulted in increased fecal fat excretion ; however , effects of milk and cheese did not differ .
CONCLUSIONS	Because the diets contained similar amounts of saturated fat , similar increases in total and LDL cholesterol could be expected ; however , both milk and cheese attenuated these responses , which seem to be explained by their calcium contents .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01317251 .

###25187345
BACKGROUND	The aim of this study was to evaluate the effectiveness of middle turbinate radiofrequency ( RF ) turbinoplasty for the management of the polypoid middle turbinate compared to middle turbinate resection and middle turbinate medialization .
METHODS	The study was performed on 90 patients at a tertiary referral hospital with nasal polyposis resistant to maximal medical treatment .
METHODS	At the time of functional endoscopic sinus surgery ( FESS ) , patients were randomized into 3 groups with respect to the management of the middle turbinate : middle turbinate turbinoplasty by RF ; partial resection of the middle turbinate ; and medialization of the middle turbinate by scarification to the septum .
METHODS	We evaluated the patients ' symptoms according to the 22-item Sino-Nasal Outcome Test ( SNOT-22 ) preoperatively and 1 year after surgery .
METHODS	Additionally , polyp recurrence and complications were compared among the 3 groups .
RESULTS	One year after surgery , there was no significant difference in SNOT-22 scores between the groups .
RESULTS	However , the RF group had a significantly lower polyp recurrence rate when compared to other groups ( p < 0.05 ) .
CONCLUSIONS	RF middle turbinate turbinoplasty could be considered an alternative to other common approaches , but it needs further long-term studies before widespread usage .

###25037139
BACKGROUND	Addition of a MEK inhibitor to a BRAF inhibitor enhances tumour growth inhibition , delays acquired resistance , and abrogates paradoxical activation of the MAPK pathway in preclinical models of BRAF-mutated melanoma .
BACKGROUND	We assessed the safety and efficacy of combined BRAF inhibition with vemurafenib and MEK inhibition with cobimetinib in patients with advanced BRAF-mutated melanoma .
METHODS	We undertook a phase 1b study in patients with advanced BRAF ( V600 ) - mutated melanoma .
METHODS	We included individuals who had either recently progressed on vemurafenib or never received a BRAF inhibitor .
METHODS	In the dose-escalation phase of our study , patients received vemurafenib 720 mg or 960 mg twice a day continuously and cobimetinib 60 mg , 80 mg , or 100 mg once a day for either 14 days on and 14 days off ( 14/14 ) , 21 days on and 7 days off ( 21/7 ) , or continuously ( 28/0 ) .
METHODS	The primary endpoint was safety of the drug combination and to identify dose-limiting toxic effects and the maximum tolerated dose .
METHODS	Efficacy was a key secondary endpoint .
METHODS	All patients treated with vemurafenib and cobimetinib were included in safety and efficacy analyses ( intention-to-treat ) .
METHODS	The study completed accrual and all analyses are final .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01271803 .
RESULTS	129 patients were treated at ten dosing regimens combining vemurafenib and cobimetinib : 66 had recently progressed on vemurafenib and 63 had never received a BRAF inhibitor .
RESULTS	Dose-limiting toxic effects arose in four patients .
RESULTS	One patient on a schedule of vemurafenib 960 mg twice a day and cobimetinib 80 mg once a day 14/14 had grade 3 fatigue for more than 7 days ; one patient on a schedule of vemurafenib 960 mg twice a day and cobimetinib 60 mg once a day 21/7 had a grade 3 prolongation of QTc ; and two patients on a schedule of vemurafenib 960 mg twice a day and cobimetinib 60 mg 28/0 had dose-limiting toxic effects-one developed grade 3 stomatitis and fatigue and one developed arthralgia and myalgia .
RESULTS	The maximum tolerated dose was established as vemurafenib 960 mg twice a day in combination with cobimetinib 60 mg 21/7 .
RESULTS	Across all dosing regimens , the most common adverse events were diarrhoea ( 83 patients , 64 % ) , non-acneiform rash ( 77 patients , 60 % ) , liver enzyme abnormalities ( 64 patients , 50 % ) , fatigue ( 62 patients , 48 % ) , nausea ( 58 patients , 45 % ) , and photosensitivity ( 52 patients , 40 % ) .
RESULTS	Most adverse events were mild-to-moderate in severity .
RESULTS	The most common grade 3 or 4 adverse events were cutaneous squamous-cell carcinoma ( 12 patients , 9 % ; all grade 3 ) , raised amounts of alkaline phosphatase ( 11 patients , 9 % ] ) , and anaemia ( nine patients , 7 % ) .
RESULTS	Confirmed objective responses were recorded in ten ( 15 % ) of 66 patients who had recently progressed on vemurafenib , with a median progression-free survival of 28 months ( 95 % CI 26-34 ) .
RESULTS	Confirmed objective responses were noted in 55 ( 87 % ) of 63 patients who had never received a BRAF inhibitor , including six ( 10 % ) who had a complete response ; median progression-free survival was 137 months ( 95 % CI 101-175 ) .
CONCLUSIONS	The combination of vemurafenib and cobimetinib was safe and tolerable when administered at the respective maximum tolerated doses .
CONCLUSIONS	The combination has promising antitumour activity and further clinical development is warranted in patients with advanced BRAF ( V600 ) - mutated melanoma , particularly in those who have never received a BRAF inhibitor ; confirmatory clinical testing is ongoing .
BACKGROUND	F Hoffmann-La Roche/Genentech .

###24854303
BACKGROUND	This study tested the hypothesis that early routine use of tranexamic acid ( TXA ) reduces mortality in a subset of the most critically injured trauma intensive care unit patients .
METHODS	Consecutive trauma patients ( n = 1,217 ) who required emergency surgery ( OR ) and/or transfusions from August 2009 to January 2013 were reviewed .
METHODS	At surgeon discretion , TXA was administered at a median of 97 minutes ( 1-g bolus then 1-g over 8 hours ) to 150 patients deemed high risk for hemorrhagic death .
METHODS	With the use of propensity scores based on age , sex , traumatic brain injury ( TBI ) , mechanism of injury , systolic blood pressure , transfusion requirements , and Injury Severity Score ( ISS ) , these patients were matched to 150 non-TXA patients .
RESULTS	The study population was 43 years old , 86 % male , 54 % penetrating mechanism of injury , 25 % TBI , 28 ISS , with 22 % mortality .
RESULTS	OR was required in 78 % at 86 minutes , transfusion was required in 97 % at 36 minutes , and 75 % received both .
RESULTS	For TXA versus no TXA , more packed red blood cells and total fluid were required , and mortality was 27 % versus 17 % ( all p < 0.05 ) .
RESULTS	The effects of TXA were similar in those with or without TBI , although ISS , fluid , and mortality were all higher in the TBI group .
RESULTS	Mortality associated with TXA was influenced by the timing of administration ( p < 0.05 ) , but any benefit was eliminated in those who required more than 2,000-mL packed red blood cells , who presented with systolic blood pressure of less than 120 mm Hg or who required OR ( all p < 0.05 ) .
CONCLUSIONS	For the highest injury acuity patients , TXA was associated with increased , rather than reduced , mortality , no matter what time it was administered .
CONCLUSIONS	This lack of benefit can probably be attributed to the rapid availability of fluids and emergency OR at this trauma center .
CONCLUSIONS	Prospective studies are needed to further identify conditions that may override the benefits from TXA .
METHODS	Therapeutic study , level IV .

###24865945
BACKGROUND	This study aimed to examine the correlation of heart rate variability ( HRV ) and meridian electrical conductance among middle-aged women during an 8-week period of auricular acupressure ( AA ) treatment for weight reduction .
METHODS	Sixty ( 60 ) subjects were randomized either to a control group ( n = 30 ) or to a treatment group with AA ( n = 30 ) .
METHODS	Anthropometric parameters , HRV indices , and meridian levels were measured before treatment , at the 5th week , and 1 week after the 8-week treatment period .
RESULTS	Although no significant changes were observed in body weight ( BW ) and body-mass index ( BMI ) from baseline to 1 week after AA treatment , a significant decrease in Waist Circumference ( WC ) was observed in the acupressure group .
RESULTS	In contrast , the subjects ' BW , BMI , and WC were significantly increased from baseline to the 9th week in the control group .
RESULTS	With adjustment for baseline low frequencies ( LF ) of HRV , the LF at the 5th and 9th weeks in the acupressure groups was generally lower than that in the control group , with a p-value = 0.027 using the mixed linear model .
RESULTS	The meridian levels for Spleen , Bladder , and Gallbladder were significantly lower in the group subjected to acupressure than in the control group at the 5th week .
CONCLUSIONS	The results of the present study indicate that AA tends to inactivate the sympathetic nervous activity demonstrated by both HRV and meridian electrical conductance changes .
CONCLUSIONS	As a result , AA may modulate the autonomic nervous system to exert its physiological effect through the pathway of the meridian system .

###25552421
OBJECTIVE	The glycemic management of patients with type 2 diabetes mellitus ( T2DM ) and renal impairment is challenging , with few treatment options .
OBJECTIVE	We investigated the effect of saxagliptin in the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus ( SAVOR ) - Thrombolysis in Myocardial Infarction ( TIMI ) 53 trial according to baseline renal function .
METHODS	Patients with T2DM at risk for cardiovascular events were stratified as having normal or mildly impaired renal function ( estimated glomerular filtration rate [ eGFR ] > 50 mL/min/1 .73 m ( 2 ) ; n = 13,916 ) , moderate renal impairment ( eGFR 30-50 mL/min/1 .73 m ( 2 ) ; n = 2,240 ) , or severe renal impairment ( eGFR < 30 mL/min/1 .73 m ( 2 ) ; n = 336 ) and randomized to receive saxagliptin or placebo .
METHODS	The primary end point was cardiovascular death , myocardial infarction , or ischemic stroke .
RESULTS	After a median duration of 2 years , saxagliptin neither increased nor decreased the risk of the primary and secondary composite end points compared with placebo , irrespective of renal function ( all P for interactions 0.19 ) .
RESULTS	Overall , the risk of hospitalization for heart failure among the three eGFR groups of patients was 2.2 % ( referent ) , 7.4 % ( adjusted hazard ratio [ HR ] 2.38 [ 95 % CI 1.95-2 .91 ] , P < 0.001 ) , and 13.0 % ( adjusted HR 4.59 [ 95 % CI 3.28-6 .28 ] , P < 0.001 ) , respectively .
RESULTS	The relative risk of hospitalization for heart failure with saxagliptin was similar ( P for interaction = 0.43 ) in patients with eGFR > 50 mL/min/1 .73 m ( 2 ) ( HR 1.23 [ 95 % CI 0.99-1 .55 ] ) , eGFR 30-50 mL/min/1 .73 m ( 2 ) ( HR 1.46 [ 95 % CI 1.07-2 .00 ] ) , and in patients with eGFR < 30 ( HR 0.94 [ 95 % CI 0.52-1 .71 ] ) .
RESULTS	Patients with renal impairment achieved reductions in microalbuminuria with saxagliptin ( P = 0.041 ) that were similar to those of the overall trial population .
CONCLUSIONS	Saxagliptin did not affect the risk of ischemic cardiovascular events , increased the risk of heart failure hospitalization , and reduced progressive albuminuria , irrespective of baseline renal function .

###25168278
BACKGROUND	High-dose statin loading is known to reduce periprocedural myocardial infarction and contrast-induced acute kidney injury in patients undergoing percutaneous coronary intervention .
BACKGROUND	However , the clinical role of high-dose statin loading in patients with acute heart failure ( AHF ) remains unknown .
RESULTS	In a prospective , single-center , randomized , controlled , open-label pilot study , patients hospitalized with AHF were randomly assigned to receive oral high-dose atorvastatin loading ( 80 mg for 3 days , followed by 10 mg/day until discharge ) or no statin therapy , on top of optimal HF treatment .
RESULTS	The primary outcome measures were changes to the level of biomarkers related to inflammation and renal injury from admission to hospital day 4 .
RESULTS	No significant changes in the levels of NT-proBNP ( -2,6274,956 vs. -2,9816,951 pg/ml , P = 0.845 ) , hsCRP ( -6.116.4 vs. -2.116.2 mg/L , P = 0.105 ) , cystatin C ( 0.0020.185 vs. 0.0090.216 mg/L , P = 0.904 ) , ACR ( -886.31,984.9 vs. -165.6825.2 mg/day , P = 0.124 ) were observed in either group .
RESULTS	In-hospital mortality ( 4.3 % vs. 3.8 % , P > 0.999 ) and all-cause mortality at 90 days ( 4.3 % vs. 3.8 % , P > 0.999 ) were not significantly different between groups .
CONCLUSIONS	This pilot study showed that oral high-dose atorvastatin loading may be used safely in patients with AHF , but is not effective in reducing the levels of circulating biomarkers related to inflammation and renal injury during hospitalization .

###24252587
BACKGROUND	There is growing recognition of a syndrome of disturbed grief referred to as prolonged grief disorder ( PGD ) .
BACKGROUND	PGD is mostly studied in adults , but clinically significant PGD symptoms have also been observed in children and adolescents .
BACKGROUND	Yet , to date no effective treatment for childhood PGD exists .
BACKGROUND	The aims of this study are : ( 1 ) to investigate the effectiveness of Grief-Help , a nine-session cognitive-behavioural treatment for childhood PGD , combined with five sessions of parental counselling , immediately after the treatment and at three , six and twelve months follow-up ; ( 2 ) to examine tentative mediators of the effects of Grief-Help , ( i.e. , maladaptive cognitions and behaviours and positive parenting ) , and ( 3 ) to determine whether demographic variables , child personality , as well as symptoms of PGD , anxiety , and depression in parents moderate the treatment effectiveness .
METHODS	We will conduct a Randomised Controlled Trial ( RCT ) in which 160 children and adolescents aged 8-18years are randomly allocated to cognitive behavioural Grief-Help or to a supportive counselling intervention ; both treatments are combined with five sessions of parental counselling .
METHODS	We will recruit participants from clinics for mental health in the Netherlands .
METHODS	The primary outcome measure will be the severity of Prolonged Grief Disorder symptoms according to the Inventory of Prolonged Grief for Children ( IPG-C ) .
METHODS	Secondary outcomes will include PTSD , depression and parent-rated internalizing and externalizing problems .
METHODS	Mediators like positive parenting and maladaptive cognitions and behaviours will be identified .
METHODS	We will also examine possible moderators including demographic variables ( e.g. time since loss , cause of death ) , psychopathology symptoms in parents ( PGD , anxiety and depression ) and child personality .
METHODS	Assessments will take place in both groups at baseline , after the treatment-phase and three , six and twelve months after the post-treatment assessment .
CONCLUSIONS	We aim to contribute to the improvement of mental health care for children and adolescents suffering from loss .
CONCLUSIONS	By comparing Grief-Help with supportive counselling , and by investigating mediators and moderators of its effectiveness we hope to provide new insights in the effects of interventions for bereaved children , and their mechanisms of change .
BACKGROUND	Netherlands Trial Register NTR3854 .

###26437499
OBJECTIVE	This randomized , single center , examiner-blind , controlled , parallel-group , 4-week clinical study compared the antiplaque/anti-gingivitis efficacy of an essential oil ( EO ) containing mouthrinse versus a 0.075 % cetylpyridinium chloride ( CPC ) containing mouthrinse .
OBJECTIVE	A 5 % hydroalcohol solution was included as a control group .
METHODS	165 systemically healthy volunteers ( 18-72 years of age ) , with mild to moderate plaque-related gingivitis were enrolled in this clinical trial ; 162 subjects completed the study .
METHODS	At baseline and 4-week visits , subjects received an oral examination , gingivitis ( MGI ) , gingival bleeding ( BI ) and plaque ( PI ) assessments .
METHODS	Following randomization , subjects began rinsing with 20 mL of the assigned mouthrinse for 30 seconds , in conjunction with their usual oral hygiene , twice daily for the duration of the study .
RESULTS	All rinses were well tolerated by the subjects .
RESULTS	EO was statistically significantly superior to CPC with a reduction in mean MGI of 5.9 % , and in mean PI of 6.4 % .
RESULTS	Statistically significant reductions in gingivitis , bleeding and plaque were observed for both EO and CPC when compared to the negative control ; mean MGI and mean PI were reduced by 13.0 % and 18.9 % for EO and by 7.6 % and 13.3 % for CPC .
RESULTS	EO also statistically significantly reduced the proportion of gingival bleeding sites compared to CPC by 7.6 % ( P = 0.012 ) and compared to control by 10.6 % ( P < 0.001 ) .
RESULTS	For the post hoc sitewise analyses , at 4 weeks , the mean percentage of healthy sites for EO , CPC and Control were 7.4 % , 1.1 % and 0.8 % , respectively and the mean percentage of virtually plaque free sites for EO , CPC and control were 5.4 % , 3.8 % and 0.4 % respectively .
RESULTS	The mean percentages of more inflamed gingival sites for EO , CPC and control were 20.4 % , 26.2 % and 45.7 % , respectively .
RESULTS	The mean percentage of tooth surfaces with heavier accumulations of plaque ( PI scores 3 ) was 50.9 % for EO , 56.1 % for CPC and 81.1 % for control .
RESULTS	Reduction of gingival inflammation and dental plaque was statistically significantly superior for EO compared to both 0.075 % CPC and negative control .
RESULTS	Both marketed antimicrobial mouthrinses showed a beneficial result in gingival health and in reducing plaque accumulation as early as 4 weeks .

###25138802
OBJECTIVE	To compare the benefits and harms of third-wave cognitive therapy versus mentalisation-based therapy in a small sample of depressed participants .
METHODS	The trial was conducted at an outpatient psychiatric clinic for non-psychotic patients in Roskilde , Denmark .
METHODS	44 consecutive adult participants diagnosed with major depressive disorder .
METHODS	18weeks of third-wave cognitive therapy ( n = 22 ) versus 18weeks of mentalisation-based treatment ( n = 22 ) .
RESULTS	The primary outcome was the Hamilton Rating Scale for Depression ( HDRS ) at end of treatment ( 18weeks ) .
RESULTS	Secondary outcomes were : remission ( HDRS < 8 ) , Beck 's Depression Inventory , Symptom Checklist 90 Revised and The WHO-Five Well-being Index 1999 .
RESULTS	The trial inclusion lasted for about 2years as planned but only 44 out of the planned 84 participants were randomised .
RESULTS	Two mentalisation-based participants were lost to follow-up .
RESULTS	The unadjusted analysis showed that third-wave participants compared with mentalisation-based participants did not differ significantly regarding the 18weeks HDRS score ( 12.9 vs 17.0 ; mean difference -4.14 ; 95 % CI -8.30 to 0.03 ; p = 0.051 ) .
RESULTS	In the analysis adjusted for baseline HDRS score , the difference was favouring third-wave cognitive therapy ( p = 0.039 ) .
RESULTS	At 18weeks , five of the third-wave participants ( 22.7 % ) were in remission versus none of the mentalisation-based participants ( p = 0.049 ) .
RESULTS	We recorded no suicide attempts or suicides during the intervention period in any of the 44 participants .
RESULTS	No significant differences were found between the two intervention groups on the remaining secondary outcomes .
CONCLUSIONS	Third-wave cognitive therapy may be more effective than mentalisation-based therapy for depressive symptoms measured on the HDRS .
CONCLUSIONS	However , more randomised clinical trials are needed to assess the effects of third-wave cognitive therapy and mentalisation-based treatment for depression .
BACKGROUND	Registered with Clinical Trials government identifier : NCT01070134 .

###25052061
BACKGROUND	Depression is a debilitating mental health problem that tends to run a chronic , recurrent course .
BACKGROUND	Even when effectively treated , relapse and recurrence rates remain high .
BACKGROUND	Accordingly , interventions need to focus not only on symptom reduction , but also on reducing the risk of relapse by targeting depression-related disturbances that persist into remission .
BACKGROUND	We are addressing this need by investigating the efficacy , acceptability and feasibility of a MEmory Specificity Training ( MEST ) programme , which directly targets an enduring cognitive marker of depression - reduced autobiographical memory specificity .
BACKGROUND	Promising pilot data suggest that training memory specificity ameliorates this disturbance and reduces depressive symptoms .
BACKGROUND	A larger , controlled trial is now needed to examine the efficacy of MEST .
BACKGROUND	This trial compares MEST to an education and support ( ES ) group , with an embedded mechanism study .
METHODS	In a single blind , parallel cluster randomised controlled trial , 60 depressed individuals meeting diagnostic criteria for a current major depressive episode will be recruited from the community and clinical services .
METHODS	Using a block randomisation procedure , groups of 5 to 8 participants will receive five weekly sessions of MEST ( n = 30 ) or education and support ( n = 30 ) .
METHODS	Participants will be assessed immediately post-treatment , and at 3 - and 6-months post-treatment ( MEST group only for 6-month follow-up ) .
METHODS	Depressive symptoms at 3-month follow-up will be the primary outcome .
METHODS	Secondary outcomes will be change in depressive status and memory specificity at post-treatment and 3-months .
METHODS	The 6-month follow-up of the MEST group will allow us to examine whether treatment gains are maintained .
METHODS	An explanatory question will examine variables mediating improvement in depression symptoms post-treatment and at 3-month follow-up .
CONCLUSIONS	This trial will allow us to investigate the efficacy of MEST , whether treatment gains are maintained , and the mechanisms of change .
CONCLUSIONS	Evidence will be gathered regarding whether this treatment is feasible and acceptable as a low-intensity intervention .
CONCLUSIONS	If efficacy can be demonstrated , the results will support MEST as a treatment for depression and provide the foundation for a definitive trial .
BACKGROUND	NCT01882452 ( ClinicalTrials.gov ) , registered on 18 June 2013 .

###25149556
OBJECTIVE	To use Fourier-domain optical coherence tomography ( OCT ) to evaluate the wound characteristics of clear corneal incisions ( CCIs ) created with a metal or diamond blade in cataract surgery .
METHODS	Department of Ophthalmology , Institute of Vision Research , Yonsei University College of Medicine , Seoul , South Korea .
METHODS	Prospective comparative observational study .
METHODS	Patients who had cataract surgery were randomized into 2 groups based on whether a metal blade ( Group 1 , 37 eyes ) or diamond blade ( Group 2 , 33 eyes ) was used to create a 2.8 mm temporal CCI .
METHODS	One day , 1 week , and 1 month postoperatively , structural characteristics of the CCI were analyzed using RTVue-100 Fourier-domain OCT. .
METHODS	Parameters included incision angle , corneal thickness , epithelial or endothelial gaps , and Descemet membrane detachment .
METHODS	Visual acuity , surgically induced astigmatism ( SIA ) , and ocular aberrations were evaluated .
RESULTS	There was a significant difference in corneal thickness at the 1.0 mm temporal side from midpoint .
RESULTS	The mean uncorrected distance visual acuity in Group 2 ( 33 eyes ) improved significantly over time .
RESULTS	In both groups , corneal thickness at the midpoint , 1.0 mm temporal side , and 1.0 mm nasal side from the midpoint of the incision significantly decreased over time .
RESULTS	At all timepoints , temporal and nasal thickness in Group 2 was significantly greater than in Group 1 ( 37 eyes ) , with the exception of temporal thickness at 1 month .
RESULTS	In both groups , wound healing was reliable over time .
RESULTS	There were no significant between-group differences in SIA or changes in aberrations .
CONCLUSIONS	Corneal thickness at the incision site showed a significant difference between the 2 groups .
CONCLUSIONS	Both groups achieved structural stabilization .
BACKGROUND	No author has a financial or proprietary interest in any material or method mentioned .

###24702445
BACKGROUND	Whereas emollients are integral to the long-term management of atopic dermatitis ( AD ) , the evidence for their efficacy in disease flares is limited .
OBJECTIVE	We aimed to investigate the stand-alone efficacy of an emollient formulation with regard to improvement of the clinical symptoms , skin barrier function and reduction of pathogenic bacterial colonization in acute stage of AD .
METHODS	Twenty AD volunteers aged 12-65 years with symmetric , mild to moderately severe inflammatory lesions on the forearms/arms were recruited for the study .
METHODS	At inclusion , the forearms/arms of each volunteer were randomized to receive for 1 week either an o/w formulation containing licochalcone A ( Glycyrrhiza Inflata root extract ) , decanediol , menthoxypropanediol and -6 - fatty acids ( emollient arm ) or 1 % hydrocortisone ( HC arm ) ; after 1 week , the application of the emollient and HC were discontinued and the volunteers applied a w/o emollient containing licochalcone A and -6 - fatty acids on both arms for further 3 weeks .
METHODS	The outcomes included reduction of the clinical and itch severity , decrease in S.aureus colonization , improvement of the barrier function , skin hydration and skin tolerability assessed after 1 week ( D7 ) and after 4 weeks ( D28 ) respectively .
RESULTS	In both arms , there was a significant decrease in the severity score , itch intensity , erythema and TEWL on D7 and D28 compared to baseline .
RESULTS	In addition , emollient use resulted in pronounced decrease in S.aureus colonization and significant increase of skin hydration on D7 .
RESULTS	The comparison of the outcomes , based on percentage change from baseline , showed no significant differences between the emollient and HC arm at any time point .
CONCLUSIONS	The results of the study indicate that the 1-week stand-alone application of an emollient , tailored to target inflammation , pruritus , compromised barrier function and pathogenic bacterial colonization may offer benefit for the improvement of mild to moderately severe localized flares of AD .

###24749723
OBJECTIVE	To determine whether a bundled intervention can increase detection of delirium and facilitate safer use of high-risk medications .
METHODS	Pre-post interventional trial .
METHODS	Large academic medical center .
METHODS	Individuals aged 70 and older ( n = 19,949 ) admitted between May 1 , 2008 , September 30 , 2011 .
METHODS	Individuals aged 80 and older admitted after April 26 , 2010 , received the intervention , those aged 80 and older admitted before were primary controls , and those aged 70 to 79 were concurrent controls .
METHODS	The intervention uses a checklist promoting delirium prevention , recognition and management , and modifies the computerized provider order entry system to provide care focused on elderly adults .
METHODS	Frequency of orders for activating the rapid response team for altered mental status , frequency of orders for haloperidol in excess of 0.5 mg or intravenous ( IV ) morphine in excess of 2 mg , and discharge disposition .
RESULTS	Participants receiving the intervention had a mean age of 86.1 4.6 ; 58.2 % were female .
RESULTS	The number of orders to activate the rapid response team for altered mental status increased in participants receiving the bundle and in controls ( odds ratio ( OR ) for the difference of differences = 1.23 ( 95 % confidence interval ( CI ) = 0.68-2 .24 , P = .49 ) ) .
RESULTS	Participants receiving the bundle were less likely to receive more than 0.5 mg of IV , intramuscular , or oral haloperidol ( OR = 0.60 , 95 % CI = 0.39-0 .91 , P = .02 ) and more than 2 mg of IV morphine ( OR = 0.52 , 95 % CI = 0.42-0 .63 , P < .001 ) .
RESULTS	Participants who received the bundle were more likely to be discharged home than to extended care facilities ( OR = 1.18 , 95 % CI = 1.04-1 .35 , P = .01 ) .
CONCLUSIONS	An intervention focused on delirium prevention and recognition by bedside staff combined with computerized decision support facilitates safer prescribing of high-risk medications and possibly results in less need for extended care .

###24855193
OBJECTIVE	The technical difficulty in the revascularization of the circumflex artery territory with off-pump surgery may compromise the outcome of this method in clinical follow-up .
OBJECTIVE	We aimed to evaluate cardiac events in patients with stable coronary artery disease and severe obstruction of the circumflex system , undergoing coronary artery bypass grafting ( CABG ) with or without cardiopulmonary bypass .
METHODS	MASS III was a single-centre study that evaluated 308 patients with multivessel coronary artery disease randomized to on-pump ( 153 ) or off-pump ( 155 ) CABG .
METHODS	Of this total , 260 ( 84.4 % ) patients had , on coronary angiography , at least one 70 % obstruction in the circumflex territory ( 141 on-pump and 119 off-pump ) .
METHODS	The combined outcome was death , myocardial infarction , target vessel revascularization ( angioplasty or surgery ) or hospitalization for cardiac causes .
METHODS	Variables with possible associations ( P < 0.1 ) were included in the multivariate analysis .
RESULTS	The two groups were well matched for demographics and clinical and angiographic characteristics .
RESULTS	After 5 years of follow-up , off-pump CABG had higher combined events than on-pump had : 25 ( 21 % ) vs 17 ( 12 % ) , hazard ratio 1.88 , 95 % confidence interval 1.02-3 .48 , P = 0.041 .
RESULTS	In the multivariate model with the inclusion of the following variables : age ( P = 0.09 ) and complete revascularization ( P = 0.68 ) , off-pump surgery remained as a predictor of combined events in 5 years , P = 0.03 .
CONCLUSIONS	In patients with multivessel coronary artery disease and severe lesions in the circumflex territory , off-pump coronary artery bypass surgery resulted in a higher incidence of cardiac events at 5-year follow-up .
BACKGROUND	ISRCTN59539154 ( http://www.controlled-trials.com ) .

###25736126
OBJECTIVE	This clinical study was conducted to investigate the effects of dexmedetomidine ( DEX ) combined with propofol on vital signs and anaesthetic depth in patients .
METHODS	Ninety patients with ASA 1-2 requiring painless colonoscopy for colonic polyps resection were randomized to receive DEX 0.3 micro ; g/kg ( group D , n = 45 ) followed by propofol 1 mg/kg or propofol 2 mg/kg ( group C , n = 45 ) , and according to the body activity and operation time , additional doses of propofol ( 0.2-0 .5 mg/kg ) were given .
METHODS	The full recovery time , operation time , consumed dose of propofol , mean arterial pressure ( MAP ) , heart rate ( HR ) , hemoglobin oxygen saturation levels ( SPO ) and NTI were recorded .
RESULTS	The SPOrecover time and the consumed dose of propofol in group D were decreased compared to those in group C ( P < 0.01 ) .
RESULTS	The rate of the body activity in group D was lower than that in group C ( P < 0.05 ) .
RESULTS	The NTI in group C was lower than that in group D ( P < 0.05 ) .
RESULTS	The HR and MAP were similar in both groups .
CONCLUSIONS	Under Narcotrend monitoring , the value of DEX combined with low dose of propofol in colonoscopy for colonic polyps resection is to reach more reasonable depth of anesthesia to reduce adverse responses and the dose of propofol .

###24548730
OBJECTIVE	To estimate whether a continuous infusion of intraperitoneal local anaesthetic for 48hours following laparoscopic hysterectomy reduced the need for opioids delivered with a patient-controlled analgesia pump .
METHODS	Double-blind randomised placebo-controlled trial .
METHODS	District general hospital in the UK .
METHODS	Women undergoing a laparoscopic hysterectomy for a benign indication .
METHODS	Women were randomised to receive either 0.5 % levobupivicaine or 0.9 % normal saline via an ON-Q elastomeric pump for 48hours postoperatively .
METHODS	The amount of opioids used via the patient-controlled analgesia pump was recorded and pain was measured using an 11-point Box Scale .
METHODS	The primary outcome was the amount of patient-administered morphine used over the first 48 postoperative hours .
METHODS	Secondary outcomes were length of hospital stay , oral analgesia use and level of patient-reported pain .
RESULTS	Sixty women participated and completed the trial .
RESULTS	There was no difference ( P = 0.59 ) in the median amount of patient-administered morphine used between the levobupivicaine ( 23mg ) and placebo ( 18.5 mg ) groups ; median group difference 3.0 ( 95 % CI -7.0 to 14.0 ) .
RESULTS	There was also no difference in the length of hospital stay with 40 % of the treatment group remaining in hospital > 48hours compared with 30 % of the placebo group ( P = 0.08 ) .
RESULTS	Pain scores at all postoperative time points remained similar , with a median group difference in pain scores of 1.0 ( 95 % CI -1.0 to 2.0 ) at the end of the first postoperative day .
CONCLUSIONS	Continuous infusion of 0.5 % levobupivicaine into the peritoneal cavity following laparoscopic hysterectomy does not have any opioid-sparing effects .

###25134740
BACKGROUND	Screen-related behaviours are highly prevalent in schoolchildren .
BACKGROUND	Considering the adverse health effects and the relation of obesity and screen time in childhood , efforts to affect screen use in children are warranted .
BACKGROUND	Parents have been identified as an important influence on children 's screen time and therefore should be involved in prevention programmes .
BACKGROUND	The aim was to examine the mediating role of family-related factors on the effects of the school-based family-focused UP4FUN intervention aimed at screen time in 10 - to 12-year-old European children ( n child-parent dyads = 1940 ) .
METHODS	A randomised controlled trial was conducted to test the six-week UP4FUN intervention in 10 - to 12-year-old children and one of their parents in five European countries in 2011 ( n child-parent dyads = 1940 ) .
METHODS	Self-reported data of children were used to assess their TV and computer/game console time per day , and parents reported their physical activity , screen time and family-related factors associated with screen behaviours ( availability , permissiveness , monitoring , negotiation , rules , avoiding negative role modeling , and frequency of physically active family excursions ) .
METHODS	Mediation analyses were performed using multi-level regression analyses ( child-school-country ) .
RESULTS	Almost all TV-specific and half of the computer-specific family-related factors were associated with children 's screen time .
RESULTS	However , the measured family-related factors did not mediate intervention effects on children 's TV and computer/game console use , because the intervention was not successful in changing these family-related factors .
CONCLUSIONS	Future screen-related interventions should aim to effectively target the home environment and parents ' practices related to children 's use of TV and computers to decrease children 's screen time .
BACKGROUND	The study is registered in the International Standard Randomised Controlled Trial Number Register ( registration number : ISRCTN34562078 ) .

###25330671
OBJECTIVE	To explore an optimal anesthesia method with less impact on hemodynamics and electrocardiogram ( ECG ) of old patients with coronary artery disease ( CHD ) during abdominal operation .
METHODS	The 133 CHD patients waiting for abdominal operation were randomly divided into continuous epidural anesthesia ( EA ) group , general anesthesia group ( GA ) and combined spinal-epidural anesthesia ( CSEA ) group .
METHODS	Continuous monitoring was carried out during operation and mean arterial pressure ( MAP ) , heart rate ( HR ) , oxygen saturation ( SaO2 ) , abnormal ECG were measured respectively at different time for comparison and the differences of the above hemodynamic parameters and abnormal ECG features were compared among the 3 groups .
RESULTS	At the 15 min and 30 min point after anesthesia , SaO2 in GA group was significantly increased compared to that in the EA group ( P < 0.05 ) .
RESULTS	At 15 min , 30 min and 60 min point after anesthesia , MAP in CSEA group was significantly increased compared to that in the EA group ( P < 0.05 ) .
RESULTS	At 30 min point after anesthesia , HR in CSEA group was increased significantly compared to the EA group ( P < 0.05 ) .
RESULTS	At 15 min and 30 min point after anesthesia , SaO2 in the CSEA group was increased significantly compare to the EA group ( P < 0.05 ) .
RESULTS	Compared with preanesthesia ( T0 ) in EA group , MAP , HR and SaO2 decreased significantly at 15 , 30 and 60 min after anesthesia ( P < 0.05 ) .
RESULTS	The fluctuation of the three parameters in GA and CSEA groups were relatively small ( P > 0.05 ) .
RESULTS	As well as the comparison of abnormal ECG among the 3 groups was concerned , the incidence of ST-T changes in GA and CSEA groups were significantly lower than that in EA group at the time of 15 min , 30 min and 60 min after anesthesia and at the time of surgery termination ( P < 0.05 , P < 0.01 ) .
RESULTS	The incidence of arrhythmia in GA and CSEA groups were significantly lower than that in EA group at the time of 15 min , 30 min and 60 min after anesthesia ( P < 0.05 , P < 0.01 ) .
RESULTS	Compared with T0 in the same group , the incidences of ST-T changes and arrhythmia in GA or CSEA group at the time of 15 , 30 and 60 min after anesthesia and at the time of surgery termination were significantly lower than that before anesthesia ( P < 0.05 , P < 0.01 ) .
CONCLUSIONS	GA and CSEA have less impact on hemodynamics and have smaller incidence of abnormal ECG of old CHD patients with abdominal operation .

###25833781
BACKGROUND	Lower levels of global DNA methylation in tissue and blood have been associated with increased cancer risk .
BACKGROUND	Conversely , cross-sectional analyses of healthier lifestyle patterns have been associated with higher levels of global DNA methylation .
OBJECTIVE	In this trial , we explored the associations between changes in lifestyle modifications ( diet , weight loss ) , metabolic markers , and global epigenetic biomarkers in white blood cells .
METHODS	Study participants were Hispanic , African American , and Afro-Caribbean overweight and sedentary female breast cancer survivors ( n = 24 ) who participated in a larger randomized , crossover , pilot study of a 6-mo weight loss intervention and who had available blood specimens .
METHODS	Anthropometric measures , a food-frequency questionnaire , and peripheral blood were collected at baseline , 6 mo , and 12 mo. .
METHODS	Plasma samples were analyzed for metabolic markers ( insulin , glucose ) .
METHODS	We measured DNA methylation of long interspersed nucleotide element 1 ( LINE-1 ) and satellite 2 by pyrosequencing and MethyLight , respectively , and global DNA methylation by the luminometric methylation assay ( LUMA ) .
RESULTS	DNA methylation of LINE-1 was statistically significantly elevated at 6 mo [ 75.5 % vs. 78.5 % ( P < 0.0001 ) ] and 12 mo [ 75.5 % vs. 77.7 % ( P < 0.0001 ) ] , compared to baseline .
RESULTS	Over a 12-mo period , changes in percentage body fat and plasma glucose concentrations were positively associated with LINE-1 DNA methylation ( = 0.19 , P = 0.001 ) and LUMA DNA methylation levels ( = 0.24 , P = 0.02 ) , respectively .
RESULTS	Similarly , 12-mo changes in dietary measures such as vegetable ( = 0.009 , P = 0.048 ) , protein ( = 0.04 , P = 0.001 ) , and total caloric ( = 0.05 , P = 0.01 ) intake were positively associated with changes in LUMA DNA methylation , as was intake of fruit positively associated with changes in LINE-1 DNA methylation ( = 0.004 , P = 0.02 ) .
CONCLUSIONS	Our hypothesis-generating results suggest that lifestyle modifications may be associated with changes in global DNA methylation detectable at 6 and 12 mo. .
CONCLUSIONS	These biomarkers may be useful intermediate biomarkers to use in future intervention trials .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT00811824 .

###24467917
BACKGROUND	Substance use problems in childhood and adolescence can severely impact youth 's physical and mental well-being .
BACKGROUND	When substance use is initiated early , the risk for moving from hazardous substance use to substance use disorders ( SUD ) is particularly high to developmentally induced biological and psychological vulnerability towards chronic trajectories in youth .
BACKGROUND	Thus , risk factors for developing SUD should be addressed early in life by adequate preventive measures reaching out to children , adolescents , and their families .
BACKGROUND	The study described in this protocol will test the effectiveness of the German adaptation of the Strengthening Families Program for Parents and Youth 10-14 ( SFP 10-14 ) aimed at ten to 14 year old adolescents and their caregivers .
METHODS	The study is conducted in four large German cities by counselling centres in the areas of youth welfare , social work and addiction aid .
METHODS	The effectiveness of the manualised group programme `` Familien Strken '' consisting of seven sessions and four booster-sessions is tested among N = 288 children and participating parents in a multicentre randomised controlled trial with standardised assessment instruments .
METHODS	The control condition receives a minimal 2-hour intervention on parenting delivered in a school setting .
METHODS	Data are collected shortly before and after as well as six and 18 months after the intervention .
METHODS	We expect to replicate the favourable effects of the SFP 10-14 programme in the United States in the area of substance use initiation , family functioning and individual psychosocial adjustment .
CONCLUSIONS	The trial is expected to contribute to the growing literature on family-based preventive interventions , their effectiveness and feasibility .
CONCLUSIONS	It is in line with several other current European efforts aimed at strengthening families against the detrimental effects of substance abuse in youth .
CONCLUSIONS	The results of these trials will expand our knowledge on adapting evidence-based interventions and delivering them in diverse cultures and settings .
BACKGROUND	Current Controlled Trials ISRCTN90251787 .

###25673981
BACKGROUND	There is excess cardiovascular mortality in patients with chronic obstructive pulmonary disease .
BACKGROUND	Aortic stiffness , an independent predictor of cardiovascular risk , and systemic and airway inflammation are increased in patients with the disease .
BACKGROUND	Statins modulate aortic stiffness and have anti-inflammatory properties .
BACKGROUND	A proof-of-principle , double-blind , randomized trial determined if 6 weeks of simvastatin 20 mg once daily reduced aortic stiffness and systemic and airway inflammation in patients with chronic obstructive pulmonary disease .
METHODS	Stable patients ( n = 70 ) were randomized to simvastatin ( active ) or placebo .
METHODS	Pre-treatment and post-treatment aortic stiffness , blood pressure , spirometry , and circulating and airway inflammatory mediators and lipids were measured .
METHODS	A predefined subgroup analysis was performed where baseline aortic pulse wave velocity ( PWV ) was > 10 m/sec .
RESULTS	Total cholesterol dropped in the active group .
RESULTS	There was no significant change in aortic PWV between the active group and the placebo group ( -0.7 m/sec , P = 0.24 ) .
RESULTS	In those with aortic stiffness > 10 m/sec ( n = 22 ) , aortic PWV improved in the active group compared with the placebo group ( -2.8 m/sec , P = 0.03 ) .
RESULTS	Neither systemic nor airway inflammatory markers changed .
CONCLUSIONS	There was a nonsignificant improvement in aortic PWV in those taking simvastatin 20 mg compared with placebo , but in those with higher baseline aortic stiffness ( a higher risk group ) a significant and clinically relevant reduction in PWV was shown .

###25420207
OBJECTIVE	Depression , cognitive impairment , and other nonmotor symptoms ( NMSs ) are common early in Parkinson disease ( PD ) and may be in part due to disease-related dopamine deficiency .
OBJECTIVE	Many patients with PD are treated with antidepressants for NMSs , and the effect of the combination of PD medications that enhance dopamine neurotransmission and antidepressants on NMSs has not been studied .
OBJECTIVE	We report the effects of the addition of a monoamine oxidase B inhibitor , rasagiline , to antidepressant treatment in PD .
OBJECTIVE	To evaluate the effect of rasagiline on depression , cognition , and other PD NMSs in patients taking an antidepressant in the Attenuation of Disease Progression With Azilect Given Once Daily ( ADAGIO ) study .
METHODS	The ADAGIO study was a double-blind , placebo-controlled , delayed-start trial of rasagiline in de novo PD .
METHODS	In this exploratory post hoc analysis , we analyzed patients taking an antidepressant during the 36-week phase 1 period , in which patients were randomized to rasagiline ( 1 or 2 mg/d ) or placebo .
METHODS	We evaluated the change in NMSs in patients taking an antidepressant and rasagiline compared with those taking placebo .
METHODS	The NMSs were assessed by Movement Disorder Society-sponsored revision of the Unified Parkinson 's Disease Rating Scale Nonmotor Experiences of Daily Living , the original Unified Parkinson 's Disease Rating Scale , and the Parkinson Fatigue Scale .
RESULTS	A total of 191 of the 1174 patients ( 16.3 % ) were treated with antidepressants during phase 1 and provided efficacy data .
RESULTS	Depression and cognition scores revealed significantly less worsening in the rasagiline group compared with the placebo group ( differences in Movement Disorder Society-sponsored revision of the Unified Parkinson 's Disease Rating Scale item-adjusted means [ SEs ] , -0.19 [ 0.10 ] , P = .048 , and -0.20 [ 0.05 ] , P < .001 , respectively ) .
RESULTS	Parkinson Fatigue Scale ( mean [ SE ] difference,-0 .42 [ 0.09 ] , P < .001 ) and daytime sleepiness ( mean [ SE ] difference,-0 .24 [ 0.09 ] , P = .006 ) scores also revealed significantly less worsening in the rasagiline group compared with placebo .
RESULTS	There was a nonsignificant trend toward less worsening in apathy and no significant between-group differences in anxiety or sleep .
RESULTS	The effect on depression remained significant after controlling for improvement in motor symptoms ( mean [ SE ] difference,-0 .23 [ 0.09 ] , P = .009 ) .
RESULTS	There were no serious adverse events in the combined rasagiline-antidepressant group suggestive of serotonin syndrome .
CONCLUSIONS	The combination of rasagiline and antidepressants in patients with de novo PD is associated with reduced worsening of a range of NMSs in preliminary analyses .
CONCLUSIONS	Adverse effects appear uncommon with this combination .
CONCLUSIONS	These findings suggest a role for dopamine-enhancing therapies in NMSs in early PD and encourage further study and confirmation .
BACKGROUND	clinicaltrials.gov Identifier : NCT00256204 .

###24449105
BACKGROUND	The prevalence of obesity has markedly increased in patients with chronic kidney disease ( CKD ) .
BACKGROUND	Studies on the impact of exercise focusing on obese CKD patients are scarce .
BACKGROUND	Therefore , we aimed to investigate the effect of aerobic exercise performed either in an exercise centre or at home on visceral fat in overweight non-dialysed CKD patients .
METHODS	Twenty-seven sedentary men ( 52.1 9.5 years , body mass index 30.4 3.8 kg/m ( 2 ) , estimated glomerular filtration rate ( eGFR ) 27.5 11.6 mL/min ) were randomly assigned to a centre-based exercise group ( n = 10 ) , home-based exercise group ( n = 8 ) or control group ( n = 9 ) .
METHODS	The aerobic training was prescribed according to ventilatory threshold and performed three times per week during 12 weeks .
METHODS	Body composition was assessed by dual energy X-ray absorptiometry ( DEXA ) and the distribution of abdominal fat by computed tomography .
RESULTS	In the centre-based group , visceral fat and waist circumference decreased 6.4 6.4 mm ( P < 0.01 ) and 2.0 2.3 cm ( P = 0.03 ) and leg lean mass increased 0.5 0.4 kg ( P < 0.01 ) .
RESULTS	No significant changes were observed in the home-based group .
RESULTS	Visceral fat increased 5.0 4.4 mm in the control group ( P = 0.01 ) .
RESULTS	In relation to the control , a group-by-time interaction was significant for visceral fat and waist circumference for both exercise groups and for leg lean mass for the centre-based group .
RESULTS	Mean blood pressure decreased in both exercise groups ( centre-based 13 % , P < 0.01 and home-based 10 % , P = 0.03 ) and eGFR increased 3.6 4.6 mL/min ( P = 0.03 ) in the centre-based group .
RESULTS	These parameters remained unchanged in the control group .
CONCLUSIONS	Centre-based aerobic exercise is an effective approach to reduce visceral fat besides promoting relevant clinical benefits in male overweight CKD patients .

###24571886
BACKGROUND	Lowering intraocular pressure ( IOP ) is currently the only therapeutic approach in primary open-angle glaucoma .
BACKGROUND	and the fixed-combination medications are needed to achieve sufficiently low target IOP .
BACKGROUND	A multicenter prospective study in the Chinese population was needed to confirm the safety and efficacy of Bimatoprost/Timolol Fixed Combination Eye Drop in China .
BACKGROUND	In this study , we evaluated the safety and efficacy of Bimatoprost/Timolol Fixed Combination with concurrent administration of its components in Chinese patients with open-angle glaucoma or ocular hypertension .
METHODS	In this multicenter , randomized , double-masked , parallel controlled study , patients with open-angle glaucoma or ocular hypertension who were insufficiently responsive to monotherapy with either topical - blockers or prostaglandin analogues were randomized to one of two active treatment groups in a 1:1 ratio at 11 Chinese ophthalmic departments .
METHODS	Bimatoprost/timolol fixed combination treatment was a fixed combination of 0.03 % bimatoprost and 0.5 % timolol ( followed by vehicle for masking ) once daily at 19:00 P.M. and concurrent treatment was 0.03 % bimatoprost followed by 0.5 % timolol once daily at 19:00 P.M.
METHODS	The primary efficacy variable was change from baseline in mean diurnal intraocular pressure ( IOP ) at week 4 visit in the intent-to-treat ( ITT ) population .
METHODS	Primary analysis evaluated the non-inferiority of bimatoprost / timolol fixed combination to concurrent with respect to the primary variable using a confidence interval ( CI ) approach .
METHODS	Bimatoprost/timolol fixed combination was to be considered non-inferior to concurrent if the upper limit of the 95 % CI for the between-treatment ( bimatoprost/timolol fixed combination minus concurrent ) difference was 1.5 mmHg .
METHODS	Adverse events were collected and slit-lamp examinations were performed to assess safety .
METHODS	Between-group comparisons of the incidence of adverse events were performed using the Pearson chi-square test or Fisher 's exact test .
RESULTS	Of the enrolled 235 patients , 121 patients were randomized to receive bimatoprost/timolol fixed combination and , 114 patients were randomized to receive concurrent treatment .
RESULTS	At baseline the mean value of mean diurnal IOP was ( 25.20 3.06 ) mmHg in the bimatoprost/timolol fixed combination group and ( 24.87 3.88 ) mmHg in the concurrent group .
RESULTS	The difference between the treatment groups was not statistically significant .
RESULTS	The mean change from baseline in mean diurnal IOP ( standard deviation ) in the bimatoprost/timolol fixed combination group was ( -9.38 4.66 ) mmHg and it was ( -8.93 4.25 ) mmHg in the concurrent group ( P < 0.01 ) .
RESULTS	The difference between the two treatment groups ( bimatoprost/timolol fixed combination minus concurrent ) in the change from baseline of mean diurnal IOP was -0.556 mmHg ( 95 % CI : -1.68 , 0.57 , P = 0.330 ) .
RESULTS	The upper limit of the 95 % CI was less than 1.5 mmHg , the predefined margin of non-inferiority .
RESULTS	Adverse events occurred in 26.4 % ( 32/121 ) of the bimatoprost/timolol fixed combination patients and 30.7 % ( 35/114 ) of the concurrent patients .
RESULTS	The most frequent adverse event was conjunctival hyperemia , which was reported as treatment related in 16.5 % ( 20/121 ) in the bimatoprost/timolol fixed combination group and 18.4 % ( 21/114 ) in the concurrent group ( P > 0.05 ) .
CONCLUSIONS	Bimatoprost/Timolol Fixed Combination administered in Chinese patients with open-angle glaucoma or ocular hypertension was not inferior to concurrent dosing with the individual components .
CONCLUSIONS	Safety profiles were similar between the treatment groups .

###25527747
BACKGROUND	The particle size and structure of masticated almonds have a significant impact on nutrient release ( bioaccessibility ) and digestion kinetics .
OBJECTIVE	The goals of this study were to quantify the effects of mastication on the bioaccessibility of intracellular lipid of almond tissue and examine microstructural characteristics of masticated almonds .
METHODS	In a randomized , subject-blind , crossover trial , 17 healthy subjects chewed natural almonds ( NAs ) or roasted almonds ( RAs ) in 4 separate mastication sessions .
METHODS	Particle size distributions ( PSDs ) of the expectorated boluses were measured by using mechanical sieving and laser diffraction ( primary outcome ) .
METHODS	The microstructure of masticated almonds , including the structural integrity of the cell walls ( i.e. , dietary fiber ) , was examined with microscopy .
METHODS	Lipid bioaccessibility was predicted by using a theoretical model , based on almond particle size and cell dimensions , and then compared with empirically derived release data .
RESULTS	Intersubject variations ( n = 15 ; 2 subjects withdrew ) in PSDs of both NA and RA samples were small ( e.g. , laser diffraction ; CV : 12 % and 9 % , respectively ) .
RESULTS	Significant differences in PSDs were found between these 2 almond forms ( P < 0.05 ) .
RESULTS	A small proportion of lipid was released from ruptured cells on fractured surfaces of masticated particles , as predicted by using the mathematical model ( 8.5 % and 11.3 % for NAs and RAs , respectively ) .
RESULTS	This low percentage of lipid bioaccessibility is attributable to the high proportion ( 35-40 % ) of large particles ( > 500 m ) in masticated almonds .
RESULTS	Microstructural examination of the almonds indicated that most intracellular lipid remained undisturbed in intact cells after mastication .
RESULTS	No adverse events were recorded .
CONCLUSIONS	Following mastication , most of the almond cells remained intact with lipid encapsulated by cell walls .
CONCLUSIONS	Thus , most of the lipid in masticated almonds is not immediately bioaccessible and remains unavailable for early stages of digestion .
CONCLUSIONS	The lipid encapsulation mechanism provides a convincing explanation for why almonds have a low metabolizable energy content and an attenuated impact on postprandial lipemia .

###24999157
BACKGROUND	Neurocysticercosis causes a substantial burden of seizure disorders worldwide .
BACKGROUND	Treatment with either praziquantel or albendazole has suboptimum efficacy .
BACKGROUND	We aimed to establish whether combination of these drugs would increase cysticidal efficacy and whether complete cyst resolution results in fewer seizures .
BACKGROUND	We added an increased dose albendazole group to establish a potential effect of increased albendazole concentrations .
METHODS	In this double-blind , placebo-controlled , phase 3 trial , patients with viable intraparenchymal neurocysticercosis were randomly assigned to receive 10 days of combined albendazole ( 15 mg/kg per day ) plus praziquantel ( 50 mg/kg per day ) , standard albendazole ( 15 mg/kg per day ) , or increased dose albendazole ( 225 mg/kg per day ) .
METHODS	Randomisation was done with a computer generated schedule balanced within four strata based on number of cysts and concomitant antiepileptic drug .
METHODS	Patients and investigators were masked to group assignment .
METHODS	The primary outcome was complete cyst resolution on 6-month MRI .
METHODS	Enrolment was stopped after interim analysis because of parasiticidal superiority of one treatment group .
METHODS	Analysis excluded patients lost to follow-up before the 6-month MRI .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00441285 .
RESULTS	Between March 3 , 2010 and Nov 14 , 2011 , 124 patients were randomly assigned to study groups ( 41 to receive combined albendazole plus praziquantel [ 39 analysed ] , 43 standard albendazole [ 41 analysed ] , and 40 increased albendazole [ 38 analysed ] ) .
RESULTS	25 ( 64 % ) of 39 patients in the combined treatment group had complete resolution of brain cysts compared with 15 ( 37 % ) of 41 patients in the standard albendazole group ( rate ratio [ RR ] 175 , 95 % CI 110-279 , p = 0014 ) .
RESULTS	20 ( 53 % ) of 38 patients in the increased albendazole group had complete cyst resolution at 6-month MRI compared with 15 ( 37 % ) of 41 patients in the standard albendazole group ( RR 144 , 95 % CI 087-238 , p = 0151 ) .
RESULTS	No significant differences in adverse events were reported between treatment groups ( 18 in combined treatment group , 11 in standard albendazole group , and 19 in increased albendazole group ) .
CONCLUSIONS	Combination of albendazole plus praziquantel increases the parasiticidal effect in patients with multiple brain cysticercosis cysts without increased side-effects .
CONCLUSIONS	A more efficacious parasiticidal regime without increased treatment-associated side-effects should improve the treatment and long term prognosis of patients with neurocysticercosis .
BACKGROUND	National Institute of Neurological Disorders and Stroke ( NINDS ) , National Institutes of Health .

###25867659
OBJECTIVE	Critical illness results in disability and reduced health-related quality of life ( HRQOL ) , but the optimum timing and components of rehabilitation are uncertain .
OBJECTIVE	To evaluate the effect of increasing physical and nutritional rehabilitation plus information delivered during the post-intensive care unit ( ICU ) acute hospital stay by dedicated rehabilitation assistants on subsequent mobility , HRQOL , and prevalent disabilities .
METHODS	A parallel group , randomized clinical trial with blinded outcome assessment at 2 hospitals in Edinburgh , Scotland , of 240 patients discharged from the ICU between December 1 , 2010 , and January 31 , 2013 , who required at least 48 hours of mechanical ventilation .
METHODS	Analysis for the primary outcome and other 3-month outcomes was performed between June and August 2013 ; for the 6 - and 12-month outcomes and the health economic evaluation , between March and April 2014 .
METHODS	During the post-ICU hospital stay , both groups received physiotherapy and dietetic , occupational , and speech/language therapy , but patients in the intervention group received rehabilitation that typically increased the frequency of mobility and exercise therapies 2 - to 3-fold , increased dietetic assessment and treatment , used individualized goal setting , and provided greater illness-specific information .
METHODS	Intervention group therapy was coordinated and delivered by a dedicated rehabilitation practitioner .
METHODS	The Rivermead Mobility Index ( RMI ) ( range 0-15 ) at 3 months ; higher scores indicate greater mobility .
METHODS	Secondary outcomes included HRQOL , psychological outcomes , self-reported symptoms , patient experience , and cost-effectiveness during a 12-month follow-up ( completed in February 2014 ) .
RESULTS	Median RMI at randomization was 3 ( interquartile range [ IQR ] , 1-6 ) and at 3 months was 13 ( IQR , 10-14 ) for the intervention and usual care groups ( mean difference , -0.2 [ 95 % CI , -1.3 to 0.9 ; P = .71 ] ) .
RESULTS	The HRQOL scores were unchanged by the intervention ( mean difference in the Physical Component Summary score , -0.1 [ 95 % CI , -3.3 to 3.1 ; P = .96 ] ; and in the Mental Component Summary score , 0.2 [ 95 % CI , -3.4 to 3.8 ; P = .91 ] ) .
RESULTS	No differences were found for self-reported symptoms of fatigue , pain , appetite , joint stiffness , or breathlessness .
RESULTS	Levels of anxiety , depression , and posttraumatic stress were similar , as were hand grip strength and the timed Up & Go test .
RESULTS	No differences were found at the 6 - or 12-month follow-up for any outcome measures .
RESULTS	However , patients in the intervention group reported greater satisfaction with physiotherapy , nutritional support , coordination of care , and information provision .
CONCLUSIONS	Post-ICU hospital-based rehabilitation , including increased physical and nutritional therapy plus information provision , did not improve physical recovery or HRQOL , but improved patient satisfaction with many aspects of recovery .
BACKGROUND	isrctn.com Identifier : ISRCTN09412438 .

###24682844
OBJECTIVE	The aim of this study was to assess the relationship between sex and clinical outcomes and treatment-related complications in patients with ST-elevation or non-ST-elevation acute coronary syndromes ( ACS ) randomized to treatment with ticagrelor or clopidogrel in the PLATelet inhibition and patient Outcomes ( PLATO ) trial .
METHODS	The associations between sex subgroup and the primary composite outcomes , secondary outcomes , and major bleeding endpoints as well as interaction of sex subgroup with treatment effects were analysed using Cox proportional-hazards models .
RESULTS	Sex was not significantly associated with the probability of the primary composite endpoint [ adjusted hazard ratio ( HR ) : 1.02 ( 0.91-1 .16 ) ] , or other adverse cardiovascular endpoints .
RESULTS	Ticagrelor was similarly more effective than clopidogrel in reducing rates of the primary endpoint in women 11.2 vs. 13.2 % [ adjusted HR : 0.88 ( 0.74-1 .06 ) ] and men 9.4 vs. 11.1 % [ adjusted HR : 0.86 ( 0.76-0 .97 ) ] ( interaction P-value 0.78 ) , all-cause death in women 5.8 vs. 6.8 % [ adjusted HR : 0.90 ( 0.69-1 .16 ) ] and men 4.0 vs. 5.7 % [ adjusted HR : 0.80 ( 0.67-0 .96 ) ] ( interaction P-value 0.49 ) , and definite stent thrombosis in women 1.2 vs. 1.4 % [ adjusted HR : 0.71 ( 0.36-1 .38 ) ] and men 1.4 vs. 2.1 % [ adjusted HR : 0.63 ( 0.45-0 .89 ) ] ( interaction P-value 0.78 ) .
RESULTS	The treatments did not differ for PLATO-defined overall major bleeding complications in women [ adjusted HR : 1.01 ( 0.83-1 .23 ) ] or men [ adjusted HR : 1.10 ( 0.98-1 .24 ) ] .
RESULTS	Sex had no significant association with these outcomes ( interactions P = 0.43-0 .88 ) .
CONCLUSIONS	Female sex is not an independent risk factor for adverse clinical outcomes in moderate-to-high risk ACS patients .
CONCLUSIONS	Ticagrelor has a similar efficacy and safety profile in men and women .

###25185149
BACKGROUND	Pulmonary rehabilitation is effective for patients with COPD , but its benefit is less clearly established in idiopathic pulmonary fibrosis ( IPF ) , especially in regard to levels of physical activity and health-related quality of life .
BACKGROUND	The objectives were to determine whether pulmonary rehabilitation increased physical activity as assessed by the International Physical Activity Questionnaire ( IPAQ ) , and improved quality of life and symptoms as assessed by the St George respiratory questionnaire for IPF ( SGRQ-I ) and the Borg dyspnea index ( BDI ) .
METHODS	Subjects who met current criteria for IPF were randomized to a 3-month pulmonary rehabilitation program ( n = 11 ) or to a control group ( n = 10 ) .
METHODS	The rehabilitation group participated in twice-weekly , 90-min exercise sessions ( 24 total sessions ) .
METHODS	The control group maintained its preceding , normal physical activity .
METHODS	All subjects underwent 6-min walk tests to assess the postexertion BDI .
METHODS	The SGRQ-I and a 5-point self-assessment of health were completed at baseline , after 3 months of intervention or observation , and after 3-month follow-up .
METHODS	All subjects completed the IPAQ weekly .
RESULTS	Subjects in the rehabilitation group maintained significantly higher levels of physical activity throughout the 3-month rehabilitation program ( rehabilitation : 51,364 57,713 [ mean SD ] metabolic equivalent of task-minutes ; control : 20,832 37,155 , P = .027 by 2-tailed Mann-Whitney test ) .
RESULTS	SGRQ-I symptom domain scores improved considerably by -9 22 in the rehabilitation group , whereas in the control group they worsened ( 16 12 rehabilitation compared with control , P = .013 by 2-tailed Mann-Whitney test ) .
RESULTS	During the 3-month follow-up , self-reported physical activity levels in the rehabilitation group were 14,428 8,884 metabolic equivalent of task-minutes and in the control group 16,923 32,620 ( P = .17 by 2-tailed Mann-Whitney test ) , demonstrating substantial reversal of activity in the rehabilitation group .
RESULTS	BDI scores after 6-min walk tests did not change significantly .
CONCLUSIONS	A 3-month rehabilitation program significantly improved symptoms ( SGRQ-I ) and physical activity levels ( IPAQ ) in subjects with IPF while they participated actively in the program .
CONCLUSIONS	( ClinicalTrials.gov registration NCT01118221 . )

###25524534
OBJECTIVE	To compare total laparoscopic hysterectomy ( TLH ) , total abdominal hysterectomy ( TAH ) and vaginal hysterectomy ( VH ) using electrosurgical bipolar vessel sealing ( EBVS ) technique regarding operative time , intra and postoperative complications .
METHODS	The current prospective randomized controlled clinical trial was conducted at Ain-shams University maternity Hospital , Cairo , Egypt .
METHODS	Ninety patients who were admitted from gynecologic outpatient clinic to undergo hysterectomy were enrolled .
METHODS	The study population was randomized according to type of hysterectomy done into 3 groups : group 1 : VH ; group 2 : AH and group 3 : TLH .
METHODS	EBVS was used in all groups .
METHODS	Three staff members ' surgeons were also randomized to operate on the patients and they were all equally competent in all the procedures .
METHODS	Main outcome measures were operative time , operative blood loss , operative complications , postoperative pain assessment using the visual analogue scale ( 0-10 ) , and the need for analgesics as well as the postoperative hospital stay .
RESULTS	Ninety patients were randomized to undergo VH , TAH or TLH for benign pathology using EBVS .
RESULTS	Postoperative pain score and the need for analgesia were least in TLH compared to the other two groups , ( p < 0.001 ) .
RESULTS	The hospital stay in TLH group was shorter than the other two groups , but there was no significant difference between VH group and TAH group with regard to hospital stay , ( p < 0.001 ) .
RESULTS	The total operative time was shortest in the VH group ( 100.4 35.8 min ) compared to TLH ( 126 42.7 min ) and TAH ( 123.6 44.5 min ) ( p = 0.033 ) .
RESULTS	The operative complications were more with VH and TAH groups .
RESULTS	The blood loss was more with VH ( p = 0.039 ) .
CONCLUSIONS	TLH had a longer operation time , yet , less blood loss , shorter hospital stay , less postoperative pain and fewer complications , compared to TAH and VH using EBVS .

###25563643
OBJECTIVE	Fibroblast growth factor 23 ( FGF23 ) is a hormone that regulates phosphorus and vitamin D metabolism .
OBJECTIVE	Elevated FGF23 concentrations are associated with excess risk of cardiovascular disease .
OBJECTIVE	Associations of FGF23 with stroke outcomes are less clear .
METHODS	Using a case-cohort study design , we examined the association of baseline plasma FGF23 concentrations with incident stroke in the Reasons for Geographic and Racial Differences in Stroke ( REGARDS ) study , a cohort of black and white adults aged 45 years .
METHODS	FGF23 was measured in 615 participants who developed incident stroke ( cases ) and in 936 participants randomly selected from the REGARDS cohort ( comparison subcohort ) .
RESULTS	In multivariable-adjusted models , higher calcium and phosphorus concentrations , lower estimated glomerular filtration rate and higher urine albumin excretion were independently associated with higher FGF23 .
RESULTS	There was no statistically significant association of FGF23 with risk of all-cause stroke in Cox models adjusted for demographic factors and established stroke risk factors ( hazard ratio comparing fourth with first quartile 1.19 ; 95 % confidence interval , 0.78-1 .82 ) .
RESULTS	In prespecified models stratified by stroke subtypes , there was a graded association of FGF23 with risk of cardioembolic stroke in fully adjusted models ( quartile 1 , reference ; quartile 2 hazard ratio , 1.48 ; 95 % confidence interval , 0.63-3 .47 ; quartile 3 hazard ratio , 1.99 ; 95 % confidence interval , 0.89-4 .44 ; quartile 4 hazard ratio , 2.52 ; 95 % confidence interval , 1.08-5 .91 ) .
RESULTS	There were no statistically significant associations of FGF23 with other ischemic stroke subtypes or with hemorrhagic strokes .
CONCLUSIONS	Higher FGF23 concentrations were associated with higher risk of cardioembolic but not with other stroke subtypes in community-dwelling adults .
CONCLUSIONS	Additional studies should delineate reasons for these findings .

###24519563
BACKGROUND	In patients undergoing regadenoson stress SPECT myocardial perfusion imaging ( MPI ) , the impact of the regimented administration of aminophylline on the cardiac-to-extracardiac photon activity ratio is unknown .
METHODS	This is a substudy of the ASSUAGE trial ( NCT01250496 ) ; a double-blinded , randomized , placebo-controlled clinical trial which investigated the attenuation of regadenoson-related adverse effects using 75 mg of intravenous aminophylline vs placebo , administered 90 seconds following ( 99m ) Tc-tetrofosmin injection in patients undergoing regadenoson stress SPECT-MPI .
METHODS	In subjects with normal MPI enrolled in the trial , we sampled from the antero-posterior planar projection of the post-stress scintigraphic data the mean photon activity in the myocardium , liver , bowel , and lungs .
METHODS	The mean cardiac-to-extracardiac activity ratios were compared between patients randomized to aminophylline vs placebo .
RESULTS	We studied 158 eligible subjects , randomized to receive aminophylline ( n = 86 ) or placebo ( n = 72 ) .
RESULTS	The means of photon activity ratios of the heart-to-liver , heart-to-bowel , heart-to-lungs , inferior wall of the heart-to-liver , and inferior wall of the heart-to-bowel were not statistically different between those who received aminophylline vs placebo ( P values > .30 ) .
RESULTS	Only the time lapse between stress ( 99m ) Tc-tetrofosmin injection and stress SPECT acquisition independently correlated with higher heart-to-liver and heart-to-bowel activity ratios ( P values .01 ) .
RESULTS	Patients ' body mass index independently correlated with lower heart-to-lung ratio ( P = .009 ) .
CONCLUSIONS	The regimented intravenous aminophylline use following regadenoson stress does not significantly improve the cardiac-to-extracardiac photon activity ratio in patients undergoing regadenoson stress ( 99m ) Tc-tetrofosmin SPECT-MPI .

###25543688
BACKGROUND	Physical inactivity is fourth in the list of risk factors for global mortality .
BACKGROUND	General practitioners are well placed to offer physical activity counseling but insufficient time is a barrier .
BACKGROUND	Although referral to an exercise specialist is an alternative , in Australia , these allied health professionals are only publicly funded to provide face-to-face counseling to patients who have an existing chronic illness .
BACKGROUND	Accordingly , this trial aims to determine the efficacy of GP referral of insufficiently active patients ( regardless of their chronic disease status ) for physical activity counseling ( either face-to-face or predominately via telephone ) by exercise specialists , based on patients ' objectively assessed physical activity levels , compared with usual care .
BACKGROUND	If the trial is efficacious , the equivalence and cost-effectiveness of face-to-face counseling versus telephone counseling will be assessed .
METHODS	This three arm pragmatic randomized trial will involve the recruitment of 261 patients from primary care clinics in metropolitan and regional areas of New South Wales , Australia .
METHODS	Insufficiently active ( less than 7000 steps/day ) consenting adult patients will be randomly assigned to : 1 ) five face-to-face counseling sessions , 2 ) one face-to-face counseling session followed by four telephone calls , or 3 ) a generic mailed physical activity brochure ( usual care ) .
METHODS	The interventions will operationalize social cognitive theory via a behavior change counseling framework .
METHODS	Participants will complete a survey and seven days of pedometry at baseline , and at three and 12 months post-randomization .
METHODS	The primary analyses will be based on intention-to-treat principles and will compare : ( i ) mean change in average daily step counts between baseline and 12 months for the combined intervention group ( Group 1 : face-to-face , and Group 2 : telephone ) and usual care ( Group 3 ) ; ( ii ) step counts at 3 months post-randomization .
METHODS	Secondary outcomes include : self-reported physical activity , sedentary behavior , quality of life , and depression .
CONCLUSIONS	If referral of primary care patients to exercise specialists increases physical activity , this process offers the prospect of systematically and sustainably reaching a large proportion of insufficiently active adults .
CONCLUSIONS	If shown to be efficacious this trial provides evidence to expand public funding beyond those with a chronic disease and for delivery via telephone as well as face-to-face consultations .
BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12611000884909 .

###25472660
BACKGROUND	Untreated advanced hepatocellular carcinoma ( HCC ) is linked to poor prognosis .
BACKGROUND	While sorafenib is the current recommended treatment for advanced HCC , radioembolisation ( RE ; also called selective internal radiation therapy or SIRT ) with yttrium-90 microspheres has shown efficacy in cohort studies .
BACKGROUND	However , there are no head-to-head trials comparing radiation therapy with yttrium-90 microspheres and sorafenib in advanced HCC .
BACKGROUND	The SARAH trial has been designed to compare the efficacy and safety of sorafenib therapy and RE using yttrium-90 resin microspheres ( SIR-Spheres ; Sirtex Medical Limited , North Sydney , Australia ) in patients with advanced HCC .
BACKGROUND	Quality of life ( QoL ) and cost-effectiveness will also be compared between therapies .
METHODS	SARAH is a prospective , randomised , controlled , open-label , multicentre trial comparing the efficacy of RE with sorafenib in the treatment of patients with advanced HCC .
METHODS	The trial aims to recruit adults with a life expectancy of > 3 months , Eastern Cooperative Oncology Group ( ECOG ) performance status 1 , and : advanced HCC according to the Barcelona criteria ( stage C ) or recurrent HCC after surgical or thermoablative treatment who are not eligible for surgical resection , liver transplantation or thermal ablation ; or two rounds of failed chemoembolisation .
METHODS	Patients will be randomised 1:1 to receive either RE or sorafenib 400 mg twice daily .
METHODS	All patients will be monitored for between 12 and 48 months following start of treatment .
METHODS	The primary endpoint of the SARAH trial is overall survival ( OS ) .
METHODS	Secondary endpoints include : adverse events , progression-free survival at 6 months ; tumour response rate ; general or liver disease-specific QoL scores ; and cost of each treatment strategy .
METHODS	Assuming an increase in median OS of 4 months with RE versus sorafenib therapy , randomising at least 400 patients ( 200 in each treatment arm ) will be sufficient for 80 % power and a bilateral alpha risk of 5 % ; therefore , 440 patients will be enrolled to allow for 10 % loss of patients due to ineligibility .
CONCLUSIONS	The SARAH trial is the first randomised head-to-head study to compare RE with sorafenib in advanced HCC , and will establish the potential role of RE in HCC treatment guidelines .
BACKGROUND	ClinicalTrials.gov identifier NCT01482442 , first received 28 November 2011 .

###25010303
OBJECTIVE	To compare the safety and efficacy of combined therapy using sildenafil and tamsulosin for management of acute urinary retention ( AUR ) with tamsulosin alone in patients with benign prostate hyperplasia ( BPH ) .
METHODS	101 patients were enrolled in a randomized placebo-controlled study from June 2009 to April 2012 .
METHODS	Patients presenting with an initial episode of spontaneous AUR underwent urethral catheterization and then prospectively randomized to receive tamsulosin 0.4 mg plus sildenafil 50mg in group A and tamsulosin 0.4 mg plus placebo in group B for three days .
METHODS	Urethral catheter was removed three days after medical treatment and patient 's ability to void assessed at the day after catheter removal and seven days later .
METHODS	Patients who voided successfully were followed at least for three months .
RESULTS	Mean age of patients was 59.64 3.84 years in group A and 60.56 4.12 years in group B ( p value = 0.92 ) .
RESULTS	Mean prostate volume and mean residual urine were comparable between both groups ( p value = 0.74 and 0.42 , respectively ) .
RESULTS	Fifteen patients in group A ( success rate : 70 % ) and nineteen patients in group B ( success rate : 62.7 % ) had failed trial without catheter ( TWOC ) at 7th day following AUR ( p value = 0.3 ) .
RESULTS	No significant difference was noted between both groups regarding the rate of repeated AUR at one month and three month follow-up period ( p = 0.07 and p = 0.45 , respectively ) .
CONCLUSIONS	It seems that combination therapy by using 5-phosphodiesterase inhibitor and tamsulosin has no significant advantages to improve urinary retention versus tamsulosin alone .

###24906043
BACKGROUND	Auto-Disable syringes are recommended for immunization because of their greater safety and preventing reuse .
BACKGROUND	In this study , the role of the syringe and needle gauge on the adverse events following Diphtheria , Tetanus toxoids and whole-cell Pertussis immunization was studied .
METHODS	In this study , 1000 children from 2 months to 6 years of age , eligible for Diphtheria , Tetanus toxoids and whole-cell Pertussis immunization and who referred to 4 health centers , were randomized into 2 groups of regular syringe users ( the Auto-Disable syringe with a 23 gauge and 25 mm needle ) and new syringe users ( the disposable syringe with a 24 gauge and 25 mm needle ) .
METHODS	Adverse events following immunization were evaluated on days 2 , 4 and 6 after immunization by visiting the children at their home and examining them .
RESULTS	The occurrence of the primary endpoint ( severe local reaction ) was found to be 2.1 % in all the children , 2.0 % in the children vaccinated with the Auto-Disable syringe and 2.2 % in the children vaccinated with the new syringe .
RESULTS	This difference is not significant ( P = 0.818 ) .
RESULTS	The evaluation of other milder adverse events ( secondary endpoints ) showed that the syringe type has no effect on the occurrence of these adverse events .
CONCLUSIONS	Syringe types and needle diameter played no role in precipitating the adverse events following immunization of the Diphtheria , Tetanus toxoids and whole-cell Pertussis vaccine .

###25976690
OBJECTIVE	To compare the long-term clinical and radiologic outcomes of temporomandibular joint osteoarthritis ( TMJ-OA ) treated with arthrocentesis plus platelet-rich plasma ( PRP ) versus arthrocentesis alone .
METHODS	A randomized clinical trial in adult patients with TMJ-OA referred to the authors ' clinic from May 2012 through July 2013 was implemented .
METHODS	The sample was composed of 30 consecutive patients with TMJ-OA treated randomly with arthrocentesis alone ( control group ) or initial arthrocentesis plus PRP injection and then 4 consecutive PRP injections ( study group ) .
METHODS	The predictor variable was treatment technique .
METHODS	The outcome variables were visual analog scale evaluations ( masticatory efficiency , joint sounds , and pain complaints ) , maximal interincisal opening , and cone-beam computed tomographic ( CBCT ) findings .
METHODS	Outcome variables were recorded preoperatively and 12 months postoperatively .
METHODS	Descriptive and bivariate statistics were computed , and significance was set at a P value less than .05 .
METHODS	The paired t and Student t tests were used for intragroup and intergroup comparisons , respectively .
RESULTS	The sample was composed of 47 joints of 30 patients with OA ( control group : 15 joints of 12 patients ; mean age , 35.08 14.84 yr ; study group : 32 joints of 18 patients ; mean age , 32.22 14.32 yr ) .
RESULTS	Joint sounds and general pain complaints decreased statistically in the 2 groups , whereas masticatory efficiency , painless interincisal opening , and lateral motion increased statistically only in the study group .
RESULTS	However , only masticatory efficiency showed statistically greater improvement in the study group compared with the control group .
RESULTS	CBCT evaluations showed that reparative remodeling of the osseous abnormalities occurred at rates of 87.5 and 46.6 % in the study and control groups , respectively .
CONCLUSIONS	These findings suggested that arthrocentesis and PRP injections constitute a safe and promising method for the treatment of TMJ-OA that is superior to arthrocentesis alone .

###24502231
BACKGROUND	Cerebral palsy is the most common cause of physical disability in childhood .
BACKGROUND	Spasticity is a significant contributor to the secondary impairments impacting functional performance and participation .
BACKGROUND	The most common lower limb spasticity management is focal intramuscular injections of Botulinum Toxin-Type A accompanied by individually-delivered ( one on one ) physiotherapy rehabilitation .
BACKGROUND	With increasing emphasis on improving goal-directed functional activity and participation within a family-centred framework , it is timely to explore whether physiotherapy provided in a group could achieve comparable outcomes , encouraging providers to offer flexible models of physiotherapy delivery .
BACKGROUND	This study aims to compare individual to group-based physiotherapy following intramuscular Botulinum Toxin-A injections to the lower limbs for ambulant children with cerebral palsy aged four to fourteen years .
METHODS	An assessor-masked , block randomised comparison trial will be conducted with random allocation to either group-based or individual physiotherapy .
METHODS	A sample size of 30 ( 15 in each study arm ) will be recruited .
METHODS	Both groups will receive six hours of direct therapy following Botulinum Toxin-A injections in either an individual or group format with additional home programme activities ( three exercises to be performed three times a week ) .
METHODS	Study groups will be compared at baseline ( T1 ) , then at 10 weeks ( T2 , efficacy ) and 26 weeks ( T3 , retention ) post Botulinum Toxin-A injections .
METHODS	Primary outcomes will be caregiver/s perception of and satisfaction with their child 's occupational performance goals ( Canadian Occupational Performance Measure ) and quality of gait ( Edinburgh Visual Gait Score ) with a range of secondary outcomes across domains of the International Classification of Disability , Functioning and Health .
CONCLUSIONS	This paper outlines the study protocol including theoretical basis , study hypotheses and outcome measures for this assessor-masked , randomised comparison trial comparing group versus individual models of physiotherapy following intramuscular injections of Botulinum Toxin-A to the lower limbs for ambulant children with cerebral palsy .
BACKGROUND	ACTRN12611000454976 .

###26109581
BACKGROUND	Amino acids are well known to be key effectors of gut protein turnover .
BACKGROUND	We recently reported that enteral delivery of proteins markedly stimulated global duodenal protein synthesis in carbohydrate-fed healthy humans , but specifically affected proteins remain unknown .
OBJECTIVE	We aimed to assess the influence of an enteral protein supply on the duodenal mucosal proteome in carbohydrate-fed humans .
METHODS	Six healthy volunteers received for 5 h , on 2 occasions and in random order , either an enteral infusion of maltodextrins alone ( 0.25 g kg h ) mimicking the fed state or maltodextrins with a protein powder ( 0.14 g proteins kg h ) .
METHODS	Endoscopic duodenal biopsy specimens were then collected and frozen until analysis .
METHODS	A 2-dimensional polyacrylamide gel electrophoresis-based comparative proteomics analysis was then performed , and differentially expressed proteins ( at least 1.5-fold change ; Student 's t test , P < 0.05 ) were identified by mass spectrometry .
METHODS	Protein expression changes were confirmed by Western blot analysis .
RESULTS	Thirty-two protein spots were differentially expressed after protein delivery compared with maltodextrins alone : 28 and 4 spots were up - or downregulated , respectively .
RESULTS	Among the 22 identified proteins , 11 upregulated proteins were involved either in the cytoskeleton ( ezrin , moesin , plastin 1 , lamin B1 , vimentin , and - actin ) or in protein biosynthesis ( glutamyl-prolyl-transfer RNA synthetase , glutaminyl-transfer RNA synthetase , elongation factor 2 , elongation factor 1 , and eukaryotic translation and initiation factor 3 subunit f ) .
CONCLUSIONS	Enteral delivery of proteins altered the duodenal mucosal proteome and mainly stimulated the expression of proteins involved in cytoskeleton and protein biosynthesis .
CONCLUSIONS	These results suggest that protein supply may affect intestinal morphology by stimulating actin cytoskeleton remodeling .

###24491134
BACKGROUND	Physical activity ( PA ) and nutrition are the cornerstones of diabetes management .
BACKGROUND	Several reviews and meta-analyses report that PA independently produces clinically important improvements in glucose control in people with Type 2 diabetes .
BACKGROUND	However , it remains unclear what the optimal strategies are to increase PA behaviour in people with Type 2 diabetes in routine primary care .
METHODS	This study will determine whether an evidence-informed multifaceted behaviour change intervention ( Movement as Medicine for Type 2 Diabetes ) targeting both consultation behaviour of primary healthcare professionals and PA behaviour in adults with Type 2 diabetes is both acceptable and feasible in the primary care setting .
METHODS	An open pilot study conducted in two primary care practices ( phase one ) will assess acceptability , feasibility and fidelity .
METHODS	Ongoing feedback from participating primary healthcare professionals and patients will provide opportunities for systematic adaptation and refinement of the intervention and study procedures .
METHODS	A two-arm parallel group clustered pilot randomised controlled trial with patients from participating primary care practices in North East England will assess acceptability , feasibility , and fidelity of the intervention ( versus usual clinical care ) and trial processes over a 12-month period .
METHODS	Consultation behaviour involving fidelity of intervention delivery , diabetes and PA related knowledge , attitudes/beliefs , intentions and self-efficacy for delivering a behaviour change intervention targeting PA behaviour will be assessed in primary healthcare professionals .
METHODS	We will rehearse the collection of outcome data ( with the focus on data yield and quality ) for a future definitive trial , through outcome assessment at baseline , one , six and twelve months .
METHODS	An embedded qualitative process evaluation and treatment fidelity assessment will explore issues around intervention implementation and assess whether intervention components can be reliably and faithfully delivered in routine primary care .
CONCLUSIONS	Movement as Medicine for Type 2 Diabetes will address an important gap in the evidence-base , that is , the need for interventions to increase free-living PA behaviour in adults with Type 2 diabetes .
CONCLUSIONS	The multifaceted intervention incorporates an online accredited training programme for primary healthcare professionals and represents , to the best of our knowledge , the first of its kind in the United Kingdom .
CONCLUSIONS	This study will establish whether the multifaceted behavioural intervention is acceptable and feasible in routine primary care .
BACKGROUND	Movement as Medicine for Type 2 Diabetes ( MaMT2D ) was registered with Current Controlled Trials on the 14th January 2012 : ISRCTN67997502 .
BACKGROUND	The first primary care practice was randomised on the 5th October 2012 .

###25189175
BACKGROUND	Dengue shock syndrome ( DSS ) fluid resuscitation by following the World Health Organization ( WHO ) guideline usually required large volumes of Ringer lactate ( RL ) that might induce secondary fluid overload .
BACKGROUND	Our objective was to compare the effectiveness of the recommended volume of RL versus a smaller volume of a hypertonic sodium lactate solution ( HSL ) in children with DSS .
BACKGROUND	The primary end point was to evaluate the effect of HSL on endothelial cell inflammation , assessed by soluble vascular cell adhesion molecule-1 ( sVCAM-1 ) measurements .
BACKGROUND	Secondarily , we considered the effectiveness of HSL in restoring hemodynamic fluid balance , acid-base status , and sodium and chloride balances , as well as in-hospital survival .
METHODS	A prospective randomized single-blind clinical trial including 50 DSS children was conducted in the Pediatrics Department of Hasan Sadikin Hospital , Bandung , Indonesia .
METHODS	Only pediatric patients ( 2 to 14 years old ) fulfilling the WHO criteria for DSS and new to resuscitation treatments were eligible .
METHODS	Patients were resuscitated with either HSL ( 5 ml/kg/BW in 15 minutes followed by 1 ml/kg/BW / h for 12 hours ) , or RL ( 20 ml/kg/BW in 15 minutes followed by decreasing doses of 10 , 7 , 5 , and 3 ml/kg BW/h for 12 hours ) .
RESULTS	In total , 50 patients were randomized and included in outcome and adverse-event analysis ; 46 patients ( 8.20.5 years ; 24.91.9 kg ; meanSEM ) completed the protocol and were fully analyzed ( 24 and 22 subjects in the HSL and RL groups , respectively ) .
RESULTS	Baseline ( prebolus ) data were similar in both groups .
RESULTS	Hemodynamic recovery , plasma expansion , clinical outcome , and survival rate were not significantly different in the two groups , whereas fluid accumulation was one third lower in the HSL than in the RL group .
RESULTS	Moreover , HSL was responsible for a partial recovery from endothelial dysfunction , as indicated by the significant decrease in sVCAM-1 .
CONCLUSIONS	Similar hemodynamic shock recovery and plasma expansion were achieved in both groups despite much lower fluid intake and fluid accumulation in the HSL group .
BACKGROUND	ClinicalTrials.gov NCT00966628 .
BACKGROUND	Registered 26 August 2009 .

###24474434
OBJECTIVE	`` Nudges '' that influence decision making through subtle cognitive mechanisms have been shown to be highly effective in a wide range of applications , but there have been few experiments to improve clinical practice .
OBJECTIVE	To investigate the use of a behavioral `` nudge '' based on the principle of public commitment in encouraging the judicious use of antibiotics for acute respiratory infections ( ARIs ) .
METHODS	Randomized clinical trial in 5 outpatient primary care clinics .
METHODS	A total of 954 adults had ARI visits during the study timeframe : 449 patients were treated by clinicians randomized to the posted commitment letter ( 335 in the baseline period , 114 in the intervention period ) ; 505 patients were treated by clinicians randomized to standard practice control ( 384 baseline , 121 intervention ) .
METHODS	The intervention consisted of displaying poster-sized commitment letters in examination rooms for 12 weeks .
METHODS	These letters , featuring clinician photographs and signatures , stated their commitment to avoid inappropriate antibiotic prescribing for ARIs .
METHODS	Antibiotic prescribing rates for antibiotic-inappropriate ARI diagnoses in baseline and intervention periods , adjusted for patient age , sex , and insurance status .
RESULTS	Baseline rates were 43.5 % and 42.8 % for control and poster , respectively .
RESULTS	During the intervention period , inappropriate prescribing rates increased to 52.7 % for controls but decreased to 33.7 % in the posted commitment letter condition .
RESULTS	Controlling for baseline prescribing rates , we found that the posted commitment letter resulted in a 19.7 absolute percentage reduction in inappropriate antibiotic prescribing rate relative to control ( P = .02 ) .
RESULTS	There was no evidence of diagnostic coding shift , and rates of appropriate antibiotic prescriptions did not diminish over time .
CONCLUSIONS	Displaying poster-sized commitment letters in examination rooms decreased inappropriate antibiotic prescribing for ARIs .
CONCLUSIONS	The effect of this simple , low-cost intervention is comparable in magnitude to costlier , more intensive quality-improvement efforts .
BACKGROUND	clinicaltrials.gov identifier : NCT01767064 .

###25698197
BACKGROUND	Blood loss after cardiac surgery can be caused by impaired platelet ( PLT ) function after cardiopulmonary bypass .
BACKGROUND	Desmopressin or 1-deamino-8-D-arginine vasopressin ( DDAVP ) is a synthetic analog of vasopressin .
BACKGROUND	DDAVP can increase the level of von Willebrand factor and coagulation factor VIII , thus it may enhance PLT function and improve coagulation .
BACKGROUND	In this study , we assessed the effects of DDAVP on PLT aggregation and blood loss in patients undergoing cardiac surgery .
METHODS	A total of 102 patients undergoing valvular heart surgery ( from October 2010 to June 2011 ) were divided into DDAVP group ( n = 52 ) and control group ( n = 50 ) .
METHODS	A dose of DDAVP ( 0.3 g/kg ) was administered to the patients intravenously when they were being re-warmed .
METHODS	At the same time , an equal volume of saline was given to the patients in the control group .
METHODS	PLT aggregation rate was measured with the AggRAM four-way PLT aggregation measurement instrument .
METHODS	The blood loss and transfusion , hemoglobin levels , PLT counts , and urine outputs at different time were recorded and compared .
RESULTS	The postoperative blood loss in the first 6 h was significantly reduced in DDAVP group ( 202 119 ml vs. 258 143 ml , P = 0.023 ) .
RESULTS	The incidence of fresh frozen plasma ( FFP ) transfusion was decreased postoperatively in DDAVP group ( 3.8 % vs. 12 % , P = 0.015 ) .
RESULTS	There was no significant difference in the PLT aggregation , urine volumes , red blood cell transfusions and blood loss after 24 h between two groups .
CONCLUSIONS	A single dose of DDAVP can reduce the first 6 h blood loss and FFP transfusion postoperatively in patients undergoing valvular heart surgery , but has no effect on PLT aggregation .

###25265492
BACKGROUND	Combined BRAF and MEK inhibition , as compared with BRAF inhibition alone , delays the emergence of resistance and reduces toxic effects in patients who have melanoma with BRAF V600E or V600K mutations .
METHODS	In this phase 3 trial , we randomly assigned 423 previously untreated patients who had unresectable stage IIIC or stage IV melanoma with a BRAF V600E or V600K mutation to receive a combination of dabrafenib ( 150 mg orally twice daily ) and trametinib ( 2 mg orally once daily ) or dabrafenib and placebo .
METHODS	The primary end point was progression-free survival .
METHODS	Secondary end points included overall survival , response rate , response duration , and safety .
METHODS	A preplanned interim overall survival analysis was conducted .
RESULTS	The median progression-free survival was 9.3 months in the dabrafenib-trametinib group and 8.8 months in the dabrafenib-only group ( hazard ratio for progression or death in the dabrafenib-trametinib group , 0.75 ; 95 % confidence interval [ CI ] , 0.57 to 0.99 ; P = 0.03 ) .
RESULTS	The overall response rate was 67 % in the dabrafenib-trametinib group and 51 % in the dabrafenib-only group ( P = 0.002 ) .
RESULTS	At 6 months , the interim overall survival rate was 93 % with dabrafenib-trametinib and 85 % with dabrafenib alone ( hazard ratio for death , 0.63 ; 95 % CI , 0.42 to 0.94 ; P = 0.02 ) .
RESULTS	However , a specified efficacy-stopping boundary ( two-sided P = 0.00028 ) was not crossed .
RESULTS	Rates of adverse events were similar in the two groups , although more dose modifications occurred in the dabrafenib-trametinib group .
RESULTS	The rate of cutaneous squamous-cell carcinoma was lower in the dabrafenib-trametinib group than in the dabrafenib-only group ( 2 % vs. 9 % ) , whereas pyrexia occurred in more patients ( 51 % vs. 28 % ) and was more often severe ( grade 3 , 6 % vs. 2 % ) in the dabrafenib-trametinib group .
CONCLUSIONS	A combination of dabrafenib and trametinib , as compared with dabrafenib alone , improved the rate of progression-free survival in previously untreated patients who had metastatic melanoma with BRAF V600E or V600K mutations .
CONCLUSIONS	( Funded by GlaxoSmithKline ; Clinical Trials.gov number , NCT01584648 . )

###25807815
OBJECTIVE	To compare the efficacy and safety between tension-free vaginal tape obturator technique ( TVT-O ) and TVT-O with biofeedback pelvic floor electrical stimulation on the therapy of female stress urinary incontinence .
METHODS	In this prospective study , 120 female patients of female stress urinary incontinence were enrolled from January 2012 to December 2013 .
METHODS	The patients were randomly assigned to two groups , 60 in group A received TVT-O alone , while 60 in group B not only received TVT-O but also received biofeedback pelvic floor electrical stimulation .
METHODS	All the patients were followed up for 12 months to assess the efficacy and safety of the two procedures .
METHODS	Subjective indices [ total volume of urine ( TV ) , the total frequency of urination ( TOV ) , the total leakage of urine events ( TL ) , urinary incontinence related quality of life questionnaire ( I-QOL ) , International Advisory Committee on urinary incontinence urinary incontinence questionnaire short form scale ( ICI-Q-SF ) ] and objective indices [ Valsalva leak point pressure ( VLPP ) , maximum flow rate ( MFR ) , residual urine volume ( RUV ) , pad test ] were analyzed .
RESULTS	Overall , the cure rate was 75 % at 1 year follow-up for group A and 88.33 % for group B ( P < 0.05 ) .
RESULTS	The effective rate was 16.67 % for group A and 10 % for group B ( P < 0.05 ) .
RESULTS	The ineffective rate was 8.33 % for group A and 1.67 % for group B ( P < 0.05 ) .
RESULTS	TV , I-QOL , ICI-Q-SF , VLPP and pad test in group B were superior to group A ( P < 0.05 ) .
CONCLUSIONS	Pelvic floor electrical stimulation biofeedback therapy could improve the curative effects of TVT-O on the treatment of female stress urinary incontinence .

###25472936
OBJECTIVE	The hypothesis that covered stents are superior to bare-metal stents ( BMS ) in long femoropopliteal artery disease was tested .
OBJECTIVE	The one-year results of the VIASTAR trial revealed a patency benefit of covered stents in the treatment-per-protocol ( TPP ) analysis only .
METHODS	A prospective , randomized , single-blind , multicenter study evaluated 141 patients with symptomatic peripheral arterial disease ( PAD ) after treatment with heparin-bonded covered stents ( VIABAHN ( ) Endoprosthesis ) or BMS .
METHODS	Clinical outcomes and patency rates were assessed at 1 , 6 , 12 , and 24 months .
METHODS	Mean lesion length was 19.0 6.3 cm in the VIABAHN ( ) versus 17.3 6.6 cm in the BMS group .
RESULTS	The 24-month primary patency rates in the VIABAHN ( ) and BMS group were : intention-to-treat 63.1 ( 95 % CI 0.52-0 .76 ) versus 41.2 % ( 95 % CI 0.29-0 .57 ; log rank p = 0.04 ) and TPP 69.4 ( 95 % CI 0.58-0 .83 ) versus 40.0 % ( 95 % CI 0.28-0 .56 ; log rank p = 0.004 ) .
RESULTS	Freedom from target-lesion-revascularization ( TLR ) was 79.4 ( 95 % CI 0.70-0 .90 ) versus 73.0 % ( 95 % CI 0.63-0 .85 ) for VIABAHN ( ) versus BMS ( log rank p = 0.37 ) .
RESULTS	For the TPP group in lesions 20 cm , the 24-month patency rates were 65.2 ( 95 % CI 0.50-0 .85 ) versus 26.7 % ( 95 % CI 0.12-0 .59 ; log rank p = 0.004 ) for VIABAHN ( ) versus BMS , and freedom from TLR was 80.0 ( 95 % CI 0.68-0 .94 ) versus 61.9 % ( 95 % CI 0.44-0 .87 ; log rank p = 0.13 ) .
RESULTS	The ankle brachial index was 0.89 0.18 versus 0.91 0.17 ( p = 0.76 ) at 24-month in the VIABAHN ( ) versus the BMS group , respectively .
CONCLUSIONS	At 24-month , this trial in PAD patients with long femoropopliteal lesions demonstrated a significantly improved primary patency rate for heparin-bonded covered stents compared to BMS , however , without a significant impact on clinical outcomes and TLR rate ( Reg .
CONCLUSIONS	Nr .
CONCLUSIONS	ISRCTN48164244 ) .

###25416400
BACKGROUND	The treat-to-target ( T2T ) approach to the care of patients with rheumatoid arthritis involves using validated metrics to measure disease activity , frequent follow-up visits for patients with moderate to high disease activity , and escalation of therapy when patients have inadequate therapeutic response as assessed by standard disease activity scores .
BACKGROUND	The study described is a newly launched cluster-randomized behavioral intervention to assess the feasibility and effectiveness of the T2T approach in US rheumatology practices .
BACKGROUND	It is designed to identify patient and provider barriers to implementing T2T management .
BACKGROUND	This initial paper focuses on the novel study design and methods created to provide these insights .
METHODS	This trial cluster-randomizes rheumatology practices from the existing Corrona network of private and academic sites rather than patients within sites or individual investigators to provide either T2T or usual care ( UC ) for qualified patients who meet the 2010 revised American College of Rheumatology criteria for the diagnosis of rheumatoid arthritis and have moderate to high disease activity .
METHODS	Specific medication choices are left to the investigator and patient , rather than being specified in the protocol .
METHODS	Enrollment is expected to be completed by the end of 2013 , with 30 practices randomized and enrolling a minimum of 530 patients .
METHODS	During the 12-month follow-up , visits are mandated as frequently as monthly in patients with active disease in the T2T group and every 3 months for the UC group .
METHODS	Safety data are collected at each visit .
METHODS	The coprimary endpoints include a comparison of the proportion of patients achieving low disease activity in the T2T and UC groups and assessment of the feasibility of implementing T2T in rheumatology practices , specifically assessment of the rates of treatment acceleration , frequency of visits , time to next visit conditional on disease activity , and probability of acceleration conditional on disease activity in the 2 groups .
CONCLUSIONS	This cluster-randomized behavioral intervention study will provide valuable insights on the outcomes and feasibility of employing a T2T treatment approach in clinical practice in the United States .
BACKGROUND	NCT01407419 .

###25503550
OBJECTIVE	We developed and validated a simple algorithm to predict the risk of hematoma growth in acute spontaneous intracerebral hemorrhage ( ICH ) to better inform clinicians and researchers in their efforts to improve outcomes for patients .
METHODS	We analyzed data from the computed tomography substudies of the pilot and main phases of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trials ( INTERACT1 and 2 , respectively ) .
METHODS	The study group was divided into a derivation cohort ( INTERACT2 , n = 964 ) and a validation cohort ( INTERACT1 , n = 346 ) .
METHODS	Multivariable logistic regression was used to identify factors associated with clinically significant ( 6 mL ) increase in hematoma volume at 24 hours after symptom onset .
METHODS	A parsimonious risk score was developed on the basis of regression coefficients derived from the logistic model .
RESULTS	A 24-point BRAIN score was derived from INTERACT2 ( C-statistic , 0.73 ) based on baseline ICH volume ( mL per score , 10 = 0 , 10-20 = 5 , > 20 = 7 ) , recurrent ICH ( yes = 4 ) , anticoagulation with warfarin at symptom onset ( yes = 6 ) , intraventricular extension ( yes = 2 ) , and number of hours to baseline computed tomography from symptom onset ( 1 = 5 , 1-2 = 4 , 2-3 = 3 , 3-4 = 2 , 4-5 = 1 , > 5 = 0 ) predicted the probability of ICH growth ( ranging from 3.4 % for 0 point to 85.8 % for 24 points ) with good discrimination ( C-statistic , 0.73 ) and calibration ( Hosmer-Lemeshow P = 0.82 ) in INTERACT1 .
CONCLUSIONS	The simple BRAIN score predicts the probability of hematoma growth in ICH .
CONCLUSIONS	This could be used to improve risk stratification for research and clinical practice .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00226096 and NCT00716079 .

###24899589
OBJECTIVE	The aim of this trial was to compare functional capacity , pulmonary shunt fraction and clinical outcomes between patients undergoing pleurotomy with a pleural drain inserted in the sub-xyphoid position and patients with a pleural drain placed in the intercostal position after off-pump coronary artery bypass surgery .
METHODS	Patients were randomized into two groups according to the pleural drain site : Group II ( n = 33 intercostal pleural drain ) ; and Group SI ( n = 35 sub-xyphoid pleural drain ) .
METHODS	Functional capacity was assessed by the distance covered on the 6-min walking test performed preoperatively and on postoperative day ( POD ) 5 ; in addition , pulmonary function test was determined preoperatively and on POD 1 and 5 .
METHODS	Pulmonary shunt fraction was evaluated preoperatively and on POD 1 , and clinical outcomes were recorded throughout the study .
RESULTS	Group SI had better preservation of lung volumes and capacities in POD compared with Group II ( P < 0.05 ) .
RESULTS	Pulmonary shunt fraction increased in both groups postoperatively ; however , Group SI showed a smaller pulmonary shunt fraction ( 0.26 0.04 vs 0.21 0.04 % ; P = 0.0014 ) .
RESULTS	Functional capacity was significantly reduced in both groups on POD 5 ; however , Group SI showed better preservation of functional capacity ( P = 0.0001 ) .
RESULTS	Group SI had better postoperative clinical results , with lower incidence of atelectasis and pleural effusion ( P < 0.05 ) , lower pain scores ( P < 0.0001 ) , and shorter orotracheal intubation and hospitalization lengths ( P < 0.001 ) .
CONCLUSIONS	Sub-xyphoid pleural drain determined better functional capacity and exercise tolerance with a smaller pulmonary shunt fraction and improved clinical outcomes compared with intercostal pleural drainage after off-pump coronary artery bypass surgery .

###24405734
BACKGROUND	Acute renal failure ( ARF ) requiring renal replacement therapy ( RRT ) occurs frequently in ICU patients and significantly affects mortality rates .
BACKGROUND	Previously , few large clinical trials investigated the impact of RRT modalities on patient outcomes .
BACKGROUND	Here we investigated the effect of two major RRT strategies ( intermittent hemodialysis ( IHD ) and continuous veno-venous hemofiltration ( CVVH ) ) on mortality and renal-related outcome measures .
METHODS	This single-center prospective randomized controlled trial ( `` CONVINT '' ) included 252 critically ill patients ( 159 male ; mean age , 61.513.9 years ; Acute Physiology and Chronic Health Evaluation ( APACHE ) II score , 28.68.8 ) with dialysis-dependent ARF treated in the ICUs of a tertiary care academic center .
METHODS	Patients were randomized to receive either daily IHD or CVVH .
METHODS	The primary outcome measure was survival at 14 days after the end of RRT .
METHODS	Secondary outcome measures included 30-day - , intensive care unit - , and intrahospital mortality , as well as course of disease severity/biomarkers and need for organ-support therapy .
RESULTS	At baseline , no differences in disease severity , distributions of age and gender , or suspected reasons for acute renal failure were observed .
RESULTS	Survival rates at 14 days after RRT were 39.5 % ( IHD ) versus 43.9 % ( CVVH ) ( odds ratio ( OR ) , 0.84 ; 95 % confidence interval ( CI ) , 0.49 to 1.41 ; P = 0.50 ) .
RESULTS	14-day - , 30-day , and all-cause intrahospital mortality rates were not different between the two groups ( all P > 0.5 ) .
RESULTS	No differences were observed in days on RRT , vasopressor days , days on ventilator , or ICU - / intrahospital length of stay .
CONCLUSIONS	In a monocentric RCT , we observed no statistically significant differences between the investigated treatment modalities regarding mortality , renal-related outcome measures , or survival at 14 days after RRT .
CONCLUSIONS	Our findings add to mounting data demonstrating that intermittent and continuous RRTs may be considered equivalent approaches for critically ill patients with dialysis-dependent acute renal failure .
BACKGROUND	NCT01228123 , clinicaltrials.gov .

###25138332
OBJECTIVE	Routine use of pulse oximetry has been associated with changes in bronchiolitis management and may have lowered the hospitalization threshold for patients with bronchiolitis .
OBJECTIVE	To examine if infants with bronchiolitis whose displayed oximetry measurements have been artificially elevated 3 percentage points above true values experience hospitalization rates at least 15 % lower compared with infants with true values displayed .
METHODS	Randomized , double-blind , parallel-group trial conducted from 2008 to 2013 in a tertiary-care pediatric emergency department in Toronto , Ontario , Canada .
METHODS	Participants were 213 otherwise healthy infants aged 4 weeks to 12 months with mild to moderate bronchiolitis and true oxygen saturations of 88 % or higher .
METHODS	Pulse oximetry measurements with true saturation values displayed or with altered saturation values displayed that have been increased 3 percentage points above true values .
METHODS	The primary outcome was hospitalization within 72 hours , defined as inpatient admission within this interval or active hospital care for greater than 6 hours .
METHODS	Secondary outcomes included the use of supplemental oxygen in the emergency department , level of physician agreement with discharge from the emergency department , length of emergency department stay , and unscheduled visits for bronchiolitis within 72 hours .
RESULTS	Forty-four of 108 patients ( 41 % ) in the true oximetry group and 26 of 105 ( 25 % ) in the altered oximetry group were hospitalized within 72 hours ( difference , 16 % [ 95 % CI for the difference , 3.6 % to 28.4 % ] ; P = .005 ) .
RESULTS	Using the emergency department physician as a random effect , the primary treatment effect remained significant ( adjusted odds ratio , 4.0 [ 95 % CI , 1.6 to 10.5 ] ; P = .009 ) .
RESULTS	None of the secondary outcomes were significantly different between the groups .
RESULTS	There were 23 of 108 ( 21.3 % ) subsequent unscheduled medical visits for bronchiolitis in the true oximetry group and 15 of 105 ( 14.3 % ) in the altered oximetry group ( difference , 7 % [ 95 % CI , -0.3 % to 0.2 % ] ; P = .18 ) .
CONCLUSIONS	Among infants presenting to an emergency department with mild to moderate bronchiolitis , those with an artificially elevated pulse oximetry reading were less likely to be hospitalized within 72 hours or to receive active hospital care for more than 6 hours than those with unaltered oximetry readings .
CONCLUSIONS	This suggests that oxygen saturation should not be the only factor in the decision to admit , and its use may need to be reevaluated .
BACKGROUND	clinicaltrials.gov Identifier : NCT00673946 .

###24388090
BACKGROUND	Voluntary medical male circumcision ( VMMC ) is a priority HIV preventive intervention .
BACKGROUND	To facilitate VMMC scale-up , the World Health Organization is seeking circumcision techniques that are faster , easier , and safer than open surgical methods .
OBJECTIVE	To compare open surgical circumcision with suturing v. the Unicirc disposable instrument plus tissue adhesive .
METHODS	We conducted a non-blinded randomised controlled trial at an outpatient primary healthcare clinic in Cape Town , South Africa , with 2:1 allocation ratio of 150 male volunteers who were at least 18 years of age .
METHODS	Our primary outcome was intraoperative time and secondary outcomes were ease of performance , post-operative pain , adverse events , time to healing , patient satisfaction and cosmetic result .
RESULTS	The intraoperative time was less with the Unicirc/adhesive technique ( median 13 v. 22.6 min , respectively ; p < 0.001 ) .
RESULTS	The intraoperative suturing rate was 17 % using the Unicirc device .
RESULTS	Other adverse events and wound healing outcomes were similar in both groups , but the cosmetic result was superior in the Unicirc group .
RESULTS	Doctors found the Unicirc procedure easier to perform and preferred it to the open surgical technique .
CONCLUSIONS	This study has important implications for the scale-up of VMMC services .
CONCLUSIONS	Excising the foreskin with the Unicirc instrument and sealing the wound with cyanoacrylate tissue adhesive in adults is quicker , easier to learn , and is potentially safer than open surgical VMMC .
CONCLUSIONS	Further studies should be conducted with the optimised device .
CONCLUSIONS	This new instrument has the potential to facilitate more rapid scale-up and save costs .

###24856557
OBJECTIVE	To assess the antidepressant efficacy of S-adenosyl methionine ( SAMe ) , a naturally occurring methyl donor , versus the selective serotonin reuptake inhibitor ( SSRI ) escitalopram and a placebo control ; and to determine whether serum histamine or carnitine levels modified treatment response .
METHODS	We examined a subsample ( n = 144 ) from one site of a two-site study of adults with diagnosed Major Depressive Disorder ( MDD ) , recruited from 4/13/05 to 12/22/09 , who consented to the additional blood draw for serum histamine and carnitine levels .
METHODS	After washout , eligible subjects were randomized to SAMe ( 1600-3200mg / daily ) , escitalopram ( 10-20mg / daily ) , or matching placebo for 12 weeks of double-blind treatment ( titration at week 6 in non-response ) .
RESULTS	On the primary outcome of the Hamilton Depression Rating Scale ( HAMD-17 ) , a significant difference in improvement was observed between groups from baseline to week 12 ( p = 0.039 ) .
RESULTS	The effect size from baseline to endpoint was moderate to large for SAMe versus placebo ( d = 0.74 ) .
RESULTS	SAMe was superior to placebo from week 1 , and to escitalopram during weeks 2 , 4 , and 6 .
RESULTS	No significant effect was found between escitalopram and placebo or SAMe .
RESULTS	Response rates ( HAMD-1750 % reduction ) at endpoint were 45 % , 31 % , and 26 % for SAMe , escitalopram , and placebo , respectively ; while remission rates ( HAM-D7 ) were 34 % for SAMe ( p = 0.003 ) , 23 % for escitalopram ( p = 0.023 ) , and 6 % for placebo .
RESULTS	No correlation between baseline histamine level and reduction of HAMD-17 score was found for either the SAMe or escitalopram groups .
RESULTS	Baseline carnitine levels were also not found to moderate response to either treatment .
CONCLUSIONS	While SAMe appears to be an effective antidepressant agent , the overall findings from the parent study ( which showed no significant difference between groups due to site differences ) must be taken into consideration .
CONCLUSIONS	These preliminary results provide encouraging evidence for the use of SAMe in the treatment of MDD .
CONCLUSIONS	Histamine and carnitine serum level may not necessarily moderate response to SAMe .

###24634205
OBJECTIVE	To assess the longterm safety and effectiveness of tocilizumab ( TCZ ) in systemic-onset juvenile idiopathic arthritis ( sJIA ) .
METHODS	The longterm extension phase of 2 pivotal studies ( phase II with 11 patients and phase III with 56 patients ) in patients with active sJIA was analyzed .
METHODS	Patients received open-label TCZ ( 8 mg/kg , every 2 weeks ) without concomitant use of disease-modifying antirheumatic drugs .
RESULTS	In total , 67 patients were enrolled .
RESULTS	All patients received corticosteroid at baseline .
RESULTS	Median duration of exposure to TCZ was 3.4 years .
RESULTS	Nine patients withdrew from the study [ 4 because of adverse events ( AE ) , 4 because of the development of anti-TCZ antibodies , and 1 because of inadequate response ] .
RESULTS	Rates of AE and serious AE were 803.7 / 100 patient-years ( PY ) and 34.7 / 100 PY , respectively .
RESULTS	The most common serious AE were infections ( 13.2 / 100 PY ) .
RESULTS	No cases of malignancy or death were reported .
RESULTS	Two serious infusion reactions were reported in patients testing negative for anti-TCZ antibodies .
RESULTS	One definite macrophage activation syndrome ( MAS ) case and 1 potential MAS case were identified .
RESULTS	American College of Rheumatology ( ACR ) response rates attained early in the TCZ treatment period were maintained throughout the study : at Week 168 , JIA ACR 30 , 50 , 70 , 90 , and 100 response rates were 80.3 % , 80.3 % , 75.4 % , 60.7 % , and 18.0 % , respectively .
RESULTS	In total , 22 of 67 patients ( 32.8 % ) completely discontinued corticosteroids without flare .
CONCLUSIONS	TCZ has demonstrated durability of effectiveness in the longterm treatment of children with sJIA and has shown good tolerability and a low discontinuation rate associated with AE , development of anti-TCZ antibodies , or inadequate response .
CONCLUSIONS	( ClinicalTrials.gov NCT00144599 and NCT00144612 ) .
CONCLUSIONS	( First Release March 15 2014 ; J Rheumatol 2014 ; 41:759 -67 ; doi :10.3899 / jrheum .130690 ) .

###25140763
OBJECTIVE	The purpose of this study was to determine the effects of a multinutritional supplement including amino acids , - hydroxy -- methylbutyrate ( HMB ) , and carbohydrates on cytokine responses to resistance exercise and training .
METHODS	Seventeen healthy , college-aged men were randomly assigned to a Muscle Armor ( MA ; Abbott Nutrition , Columbus , OH ) or placebo supplement group and 12 weeks of resistance training .
METHODS	An acute resistance exercise protocol was administered at 0 , 6 , and 12 weeks of training .
METHODS	Venous blood samples at pre - , immediately post - , and 30-minutes postexercise were analyzed via bead multiplex immunoassay for 17 cytokines .
RESULTS	After 12 weeks of training , the MA group exhibited decreased interferon-gamma ( IFN - ) and interleukin ( IL ) -10 .
RESULTS	IL-1 differed by group at various times .
RESULTS	Granulocyte colony-stimulating factor ( G-CSF ) , granulocyte-macrophage colony-stimulating factor ( GM-CSF ) , IL-6 , IL-7 , IL-8 , IL-12p70 , IL-13 , IL-17 , monocyte chemoattractant protein-1 ( MCP-1 ) , and macrophage inflammatory protein-1 beta ( MIP-1 ) changed over the 12-week training period but did not differ by group .
CONCLUSIONS	Twelve weeks of resistance training alters the cytokine response to acute resistance exercise , and supplementation with HMB and amino acids appears to further augment this result .

###24751502
OBJECTIVE	To determine the short-term clinical effects of levosimendan in acute myocardial infarction ( AMI ) patients with myocardial stunning after emergency percutaneous coronary intervention ( PCI ) .
METHODS	The study population consisted of 30 patients with AMI who received emergency PCI and satisfied the inclusion criteria .
METHODS	Levosimendan was given as a continuous infusion of 0.1 g/kg/min for 24 h , and the remaining 10 patients received placebo treatment .
METHODS	The patients were observed with invasive haemodynamic monitoring and were evaluated biochemically and echocardiographically before and after the drug infusion .
RESULTS	Following treatment , biochemical indices ( not including creatine kinase and its MB fraction ) were significantly lower in the levosimendan group than in the placebo group .
RESULTS	Meanwhile , left-ventricular ( LV ) end-systolic volume , mean pulmonary arterial pressure , pulmonary capillary wedge pressure and systemic vascular resistance were significantly reduced in the levosimendan group , whereas the early-to-late diastolic velocities ratio , LV ejection fraction , cardiac index and cardiac power index were increased .
RESULTS	Troponin I levels were reduced and fewer stunned and infarction segments were observed in the patients treated with levosimendan .
CONCLUSIONS	Levosimendan can significantly improve the myocardium function of patients with myocardial stunning after PCI .

###24266715
BACKGROUND	Treatment with rosiglitazone , a peroxisome proliferator-activated receptor - agonist , in type 2 diabetic mellitus ( T2DM ) patients is under scrutiny because it affects adversely cardiovascular outcomes .
BACKGROUND	In T2DM patients , with existing coronary heart disease , short-term treatment with rosiglitazone increases myocardial glucose uptake ( MGU ) .
BACKGROUND	Serum metabolic and lipoprotein subclass changes , which may be associated with this rosiglitazone-induced improvement , are unknown .
METHODS	Patients with both T2DM and coronary heart disease were separated into placebo ( n = 26 ) and treatment ( rosiglitazone 4-8 mg ; n = 25 ) groups .
METHODS	After 16 weeks of treatment , serum NMR metabolomics was used to measure circulating low-molecular-weight metabolites and lipoprotein subclasses and lipids that are associated with T2DM before and after the treatment .
METHODS	Significant metabolic measure changes after rosiglitazone treatment were correlated to MGU values assessed with [ ( 18 ) F ] fluorodeoxyglucose positron emission tomography .
RESULTS	Compared to placebo , the treatment significantly increased circulating glutamine and decreased lactate concentrations .
RESULTS	Circulating lactate concentrations showed a significant inverse association with MGU after rosiglitazone treatment .
CONCLUSIONS	In T2DM patients with existing coronary heart disease , short-term rosiglitazone treatment caused minor improvements in metabolism : serum lactate and glutamine concentrations changed , reflecting improvements in insulin sensitivity , and circulating lactate concentrations inversely correlated to increases in myocardial glucose uptake .

###25517587
OBJECTIVE	This study aims at ascertaining the capacity of 2 groups of young athletes to be faithful to the initial oral prevention project , with the difference that the study group received motivational reminders by either researchers and technical staff members of the team during the observation period , while the control group did not receive any motivational reminders .
METHODS	This observational study was based on two groups selected from a wide group of 150 adolescent basketball players who accepted to use a custom-made mouth guard during their sport sessions .
METHODS	None of the selected athletes ( 60 adolescents aged between 12 and 15 years ) had ever worn a mouth guard during their sports activity .
METHODS	A customised mouth guard was supplied , and subjetcs were requested to wear it for 12 months during training sessions and competitions .
METHODS	The study group was composed of 30 athletes , 15 males and 15 females , who received a constant motivational reinforcement to the use of the mouth guard by their coach and during checkups .
METHODS	Similarly , the control group was composed of 30 athletes ( 15 males and 15 females ) who did not receive any motivational reinforcement .
RESULTS	Twelve months after the beginning of the study , 24 subjects belonging to the control group were not using the mouth guard , while only 7 subjects of the study group were not using it .
RESULTS	It was also noticed , six months after the beginning of the observation period , a rapid decline in the participants ' interest in the use of the mouth guard .
CONCLUSIONS	No traumatic event was registered among those adolescents who had used the mouth guard for the whole period of the study .
CONCLUSIONS	Female athletes showed greater compliance to this prevention project .
CONCLUSIONS	It is important that all technical staff members , and particularly the leading coach , encourage the regular use of oral protection devices for prevention among teenagers practicing sports .

###24885096
BACKGROUND	Physical activity is important for a healthy lifestyle .
BACKGROUND	Although physical activity can delay complications and decrease the burden of the disease , the level of activity of patients with chronic obstructive pulmonary disease ( COPD ) or type 2 Diabetes Mellitus ( DM2 ) is often far from optimal .
BACKGROUND	To stimulate physical activity , a monitoring and feedback tool , consisting of an accelerometer linked to a smart phone and webserver ( It 's LiFe !
BACKGROUND	tool ) , and a counselling protocol for practice nurses in primary care was developed ( the Self-management Support Program ) .
BACKGROUND	The main objective of this study is to measure the longitudinal effects of this counselling protocol and the added value of using the tool .
METHODS	This three-armed cluster randomised controlled trial with 120 participants with COPD and 120 participants with DM2 ( aged 40-70 ) , compares the counselling protocol with and without the use of the tool ( group 1 and 2 ) with usual care ( group 3 ) .
METHODS	Recruitment takes place at GP practices in the southern regions of the Netherlands .
METHODS	Randomisation takes place at the practice level .
METHODS	The intended sample ( three arms of 8 practices ) powers the study to detect a 10-minute difference of moderate and intense physical activity per day between groups 1 and 3 .
METHODS	Participants in the intervention groups have to visit the practice nurse 3-4 times for physical activity counselling , in a 4-6-month period .
METHODS	Specific activity goals tailored to the individual patient 's preferences and needs will be set .
METHODS	In addition , participants in group 1 will be instructed to use the tool in daily life .
METHODS	The primary outcome , physical activity , will be measured in all groups with a physical activity monitor ( PAM ) .
METHODS	Secondary outcomes are quality of life , general - and exercise - self-efficacy , and health status .
METHODS	Follow-up will take place after 6 and 9months .
METHODS	Separately , a process evaluation will be conducted to explore reasons for trial non-participation , and the intervention 's acceptability for participating patients and nurses .
CONCLUSIONS	Results of this study will give insight into the effects of the It 's LiFe !
CONCLUSIONS	monitoring and feedback tool combined with care from a practice nurse for people with COPD or DM2 on physical activity .
BACKGROUND	ClinicalTrials.gov : NCT01867970 .

###25118795
BACKGROUND	Pre-exposure prophylaxis ( PrEP ) may be an important safer conception strategy for HIV-1-uninfected women with HIV-1-infected partners .
BACKGROUND	Understanding medication adherence in this population may inform whether PrEP is a feasible safer conception strategy .
METHODS	We evaluated predictors of pregnancy and adherence to study medication among HIV-1-uninfected women enrolled in a randomized placebo-controlled trial of PrEP among African HIV-1-serodiscordant couples .
METHODS	Participants were counseled on HIV-1 risk reduction , contraception , and adherence and tested for pregnancy at monthly study visits .
METHODS	Pill counts of dispensed drug were performed and , at a subset of visits , plasma was collected to measure active drug concentration .
RESULTS	Among 1785 women , pregnancy incidence was 10.2 per 100 person-years .
RESULTS	Younger age , not using contraception , having an additional sexual partner , and reporting unprotected sex were associated with increased likelihood of pregnancy .
RESULTS	Monthly clinic pill counts estimated that women experiencing pregnancy took 97 % of prescribed doses overall , with at least 80 % pill adherence for 98 % of study months , and no difference in adherence in the periconception period compared with previous periods ( P = 0.98 ) .
RESULTS	Tenofovir was detected in plasma at 71 % of visits where pregnancy was discovered .
RESULTS	By multiple measures , adherence was similar for women experiencing and not experiencing pregnancy ( P 0.1 ) .
CONCLUSIONS	In this clinical trial of PrEP , pregnancy incidence was 10 % per year despite excellent access to effective contraception .
CONCLUSIONS	Women experiencing pregnancy had high medication adherence , suggesting that PrEP may be an acceptable and feasible safer conception strategy for HIV-1-uninfected women with HIV-1-serodiscordant partners .

###25211369
BACKGROUND	Patients with acute coronary syndrome and concomitant atrial fibrillation may require antithrombotic triple therapy but clinical evidence of safety and efficacy is poor .
BACKGROUND	We have therefore studied the combination of different antithrombotic medicines for coagulation activation in an in vivo model in the skin microvasculature .
RESULTS	Platelet activation ( - thromboglobulin [ - TG ] ) and thrombin generation ( prothrombin fragment 1 + 2 [ F1 +2 ] , thrombin-antithrombin complex [ TAT ] ) were studied in an open-label , randomized , parallel group trial in 60 healthy male subjects ( n = 20 per group ) who received ticagrelor and acetylsalicylic acid ( ASA ) in combination with dabigatran ( 150 mg bid ) , rivaroxaban ( 20 mg od ) or phenprocoumon ( INR 2.0-3 .0 ) .
RESULTS	Coagulation biomarkers in shed blood were assessed at 3 h after monotherapy with the medicines under study , at 3 h after triple therapy dosing and at steady state trough conditions .
RESULTS	Single doses of ticagrelor , dabigatran or rivaroxaban caused comparable decreases in shed blood - TG and were more pronounced than phenprocoumon at an INR of 2.0-3 .0 .
RESULTS	In contrast , thrombin generation was more affected by rivaroxaban and phenprocoumon than by dabigatran .
RESULTS	During triple therapy a similarly sustained inhibition of platelet activation and thrombin generation with a maximum decrease of - TG , F1 +2 and TAT at 3 h post-dosing was noted , which remained below pre-dose levels at trough steady state .
CONCLUSIONS	A triple therapy at steady state with ticagrelor plus ASA in combination with dabigatran or rivaroxaban is as effective as a combination with phenprocoumon for platelet activation and thrombin generation in vivo .

###26089047
BACKGROUND	Apremilast works intracellularly to regulate inflammatory mediators .
OBJECTIVE	ESTEEM 1 evaluated efficacy/safety of apremilast at 30 mg twice a day for moderate to severe plaque psoriasis .
METHODS	This phase III , multicenter , double-blind , placebo-controlled study randomized adults ( 2:1 ) to apremilast or placebo .
METHODS	At week 16 , the placebo group switched to apremilast through week 32 , followed by a randomized treatment withdrawal phase to week 52 .
METHODS	Binary end points were analyzed using ( 2 ) test ; continuous end points used analysis of covariance .
RESULTS	In all , 844 patients were randomized ( n = 282 , placebo ; n = 562 , apremilast ) .
RESULTS	At week 16 , significantly more patients taking apremilast achieved 75 % or greater reduction from baseline Psoriasis Area and Severity Index score ( PASI-75 ) ( 33.1 % ) versus placebo ( 5.3 % , P < .0001 ; primary end point ) .
RESULTS	Most ( 61.0 % ) patients rerandomized to apremilast at week 32 achieved PASI-75 at week 52 versus 11.7 % rerandomized to placebo .
RESULTS	Of patients rerandomized to apremilast at week 32 , mean percentage change from baseline PASI score was -88 % to -81 % ( weeks 32-52 ) .
RESULTS	During the placebo-controlled period , 55.7 % and 69.3 % of patients randomized toplacebo and apremilast , respectively , had 1 or more adverse events .
RESULTS	Most adverse events were mild/moderate in severity .
RESULTS	No new significant adverse events emerged with continued apremilast exposure versus the placebo-controlled period .
CONCLUSIONS	Data were limited to 52 weeks and may not generalize to nonplaque psoriasis .
CONCLUSIONS	Apremilast was effective in moderate to severe plaque psoriasis .

###25620217
OBJECTIVE	To clarify the potential value of second-look laparoscopy ( SLL ) in improving fertility outcomes after laparoscopic salpingostomy for tubal pregnancy .
METHODS	Randomized controlled trial .
METHODS	West China Second University Hospital , Sichuan University .
METHODS	216 women with future birth demand who underwent laparoscopic salpingostomy for tubal pregnancy .
METHODS	SLL was performed in the SLL group at 3 months after the primary surgery .
RESULTS	In both the SLL and control groups , the subjects were assigned to a slight adhesion ( SLA ) or severe adhesion ( SEA ) subgroup .
RESULTS	At 3-year follow-up , the fertility outcomes were compared between the SLL and control groups and also between the SLA and SEA subgroups .
RESULTS	The intrauterine pregnancy rate was higher in the SLL group compared with the control group ( 63.1 % vs 48.6 % ; p = .032 ) , and the incidence of recurrent ectopic pregnancy was lower in the SLL group than in the control group ( 6.3 % vs 16.2 % ; p = .021 ) .
RESULTS	In the control group , the cumulative pregnancy rate was higher in the SLA subgroup compared with the SEA subgroup ( p = .017 ) , but in the SLL group , the cumulative pregnancy rate did not differ between the 2 subgroups ( p = .502 ) .
RESULTS	The cumulative pregnancy rate was higher in the SEA subgroup of the SLL group compared with the SEA subgroup of the control group ( p = .014 ) , but did not differ between the SLA subgroup of the SLL group and the SLA subgroup of the control group ( p = .456 ) .
CONCLUSIONS	SLL may improve subsequent fertility outcome after laparoscopic salpingostomy for tubal pregnancy , and may be especially recommended for women with severe and extensive pelvic adhesions .

###26159065
BACKGROUND	Optimum management strategies for patients with advanced non-small-cell lung cancer ( NSCLC ) with acquired resistance to EGFR tyrosine-kinase inhibitors are undefined .
BACKGROUND	We aimed to assess the efficacy and safety of continuing gefitinib combined with chemotherapy versus chemotherapy alone in patients with EGFR-mutation-positive advanced NSCLC with acquired resistance to first-line gefitinib .
METHODS	The randomised , phase 3 , multicentre IMPRESS study was done in 71 centres in 11 countries in Europe and the Asia-Pacific region .
METHODS	Eligible patients were aged at least 18 years with histologically confirmed , chemotherapy-naive , stage IIIB-IV EGFR-mutation-positive advanced NSCLC with previous disease control with first-line gefitinib and recent disease progression ( Response Evaluation Criteria in Solid Tumors version 1.1 ) .
METHODS	Participants were randomly assigned ( 1:1 ) by central block randomisation to oral gefitinib 250 mg or placebo once daily in tablet form ; randomisation did not include stratification factors .
METHODS	All patients also received the platinum-based doublet chemotherapy cisplatin 75 mg/m ( 2 ) plus pemetrexed 500 mg/m ( 2 ) on the first day of each cycle .
METHODS	After completion of a maximum of six chemotherapy cycles , patients continued their randomly assigned treatment until disease progression or another discontinuation criterion was met .
METHODS	All study investigators and participants were masked to treatment allocation .
METHODS	The primary endpoint was progression-free survival in the intention-to-treat population .
METHODS	Safety was assessed in patients who received at least one dose of study treatment .
METHODS	The study has completed enrolment , but patients are still in follow-up for overall survival .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01544179 .
RESULTS	Between March 29 , 2012 , and Dec 20 , 2013 , 265 patients were randomly assigned : 133 to the gefitinib group and 132 to the placebo group .
RESULTS	At the time of data cutoff ( May 5 , 2014 ) , 98 ( 74 % ) patients had disease progression in the gefitinib group compared with 107 ( 81 % ) in the placebo group ( hazard ratio 086 , 95 % CI 065-113 ; p = 027 ; median progression-free survival 54 months in both groups [ 95 % CI 45-57 in the gefitinib group and 46-55 in the placebo group ] ) .
RESULTS	The most common adverse events of any grade were nausea ( 85 [ 64 % ] of 132 patients in the gefitinib group and 81 [ 61 % ] of 132 patients in the placebo group ) and decreased appetite ( 65 [ 49 % ] and 45 [ 34 % ] ) .
RESULTS	The most common adverse events of grade 3 or worse were anaemia ( 11 [ 8 % ] of 132 patients in the gefitinib group and five [ 4 % ] of 132 patients in the placebo group ) and neutropenia ( nine [ 7 % ] and seven [ 5 % ] ) .
RESULTS	37 ( 28 % ) of 132 patients in the gefitinib group and 28 ( 21 % ) of 132 patients in the placebo group reported serious adverse events .
CONCLUSIONS	Continuation of gefitinib after radiological disease progression on first-line gefitinib did not prolong progression-free survival in patients who received platinum-based doublet chemotherapy as subsequent line of treatment .
CONCLUSIONS	Platinum-based doublet chemotherapy remains the standard of care in this setting .
BACKGROUND	AstraZeneca .

###25208030
OBJECTIVE	During endoscopic retrograde cholangiopancreatography ( ERCP ) , a guidewire is used to cannulate biliary strictures and allow for therapeutic interventions .
OBJECTIVE	The aim of this study was to assess the success of stricture cannulation using a combination of a flexible guidewire and a stable nitinol wire vs. a novel , single , stiff-shaft , flexible-tip guidewire .
METHODS	Consecutive patients who were scheduled for ERCP for biliary obstruction were randomized to undergo the procedure with either a 260-cm long , angled-tip hydrophilic wire in combination with a nitinol wire as required ( standard group ) , or a novel , 270-cm guidewire featuring a hyperflexible , hydrophilic tip with a stiff shaft ( novel group ) .
METHODS	At unsuccessful negotiation of the stricture , patients in the standard group were switched to the novel guidewire and vice versa ( `` crossover '' ) .
METHODS	Successful cannulation ( primary success : as assigned ; final success : after `` crossover '' ) , procedure time , and total number of wires needed per procedure were compared .
RESULTS	A total of 222 patients were randomized and 197 were included in the study ( 97 in the standard group and 100 in the novel group ) .
RESULTS	The primary success rate was significantly higher in the novel group ( 94/100 , 94 % ) compared with the standard group ( 77/97 , 79 % ; P = 0.00041 ) , and final success was similar .
RESULTS	Mean time ( median , interquartile range ) to stricture cannulation was 11.2 minutes ( 6.3 , 3.7-14 .6 ) in the standard group and 8.1 minutes ( 2.5 , 0.9-7 .7 ) in the novel group ( P < 0.0001 ) .
RESULTS	The mean total procedure time was 31.2 minutes ( 24.6 , 16.5-40 .8 ) vs. 24.3 minutes ( 16.9 , 10.0-31 .5 ) , respectively ( P = 0.0011 ) .
RESULTS	There were no complications observed with either of the guidewires .
CONCLUSIONS	A guidewire that features a flexible tip with a stable shaft could replace the use of a combination of flexible and stable guidewires and increase the success rate of stricture cannulation while decreasing the procedure time.ClinicalTrials.gov Identifier : NCT 01382680 .

###24280856
OBJECTIVE	Questions enhance learning in Web-based courses , but preliminary evidence suggests that too many questions may interfere with learning .
OBJECTIVE	The authors sought to determine how varying the number of self-assessment questions affects knowledge outcomes in a Web-based course .
METHODS	The authors conducted a randomized crossover trial in one internal medicine and one family medicine residency program between January 2009 and July 2010 .
METHODS	Eight Web-based modules on ambulatory medicine topics were developed , with varying numbers of self-assessment questions ( 0 , 1 , 5 , 10 , or 15 ) .
METHODS	Participants completed modules in four different formats each year , with sequence randomly assigned .
METHODS	Participants completed a pretest for half their modules .
METHODS	Outcomes included knowledge , completion time , and module ratings .
RESULTS	One hundred eighty residents provided data .
RESULTS	The mean ( standard error ) percent correct knowledge score was 53.2 ( 0.8 ) for pretests and 73.7 ( 0.5 ) for posttests .
RESULTS	In repeated-measures analysis pooling all data , mean posttest knowledge scores were highest for the 10 - and 15-question formats ( 75.7 [ 1.1 ] and 74.4 [ 1.0 ] , respectively ) and lower for 0 - , 1 - , and 5-question formats ( 73.1 [ 1.3 ] , 72.9 [ 1.0 ] , and 72.8 [ 1.5 ] , respectively ) ; P = .04 for differences across all modules .
RESULTS	Modules with more questions generally took longer to complete and were rated higher , although differences were small .
RESULTS	Residents most often identified 10 questions as ideal .
RESULTS	Posttest knowledge scores were higher for modules that included a pretest ( 75.4 [ 0.9 ] versus 72.2 [ 0.9 ] ; P = .0002 ) .
CONCLUSIONS	Increasing the number of self-assessment questions improves learning until a plateau beyond which additional questions do not add value .

###24532596
BACKGROUND	Low compliance with training programs is likely to be one of the major reasons for inconsistency of the data regarding the effectiveness of current anterior cruciate ligament ( ACL ) injury prevention programs .
BACKGROUND	Training methods that reduce training time and cost could favorably influence the effectiveness of ACL injury prevention programs .
BACKGROUND	A newly designed knee extension constraint training device may serve this purpose .
OBJECTIVE	( 1 ) Knee extension constraint training for 4 weeks would significantly increase the knee flexion angle at the time of peak impact posterior ground-reaction force and decrease peak impact ground-reaction forces during landing of a stop-jump task and a side-cutting task , and ( 2 ) the training effects would be retained 4 weeks after completion of the training program .
METHODS	Controlled laboratory study .
METHODS	Twenty-four recreational athletes were randomly assigned to group A or B. Participants in group A played sports without wearing a knee extension constraint device for 4 weeks and then played sports while wearing the device for 4 weeks , while participants in group B underwent a reversed protocol .
METHODS	Both groups were tested at the beginning of week 1 and at the ends of weeks 4 and 8 without wearing the device .
METHODS	Knee joint angles were obtained from 3-dimensional videographic data , while ground-reaction forces were measured simultaneously using force plates .
METHODS	Analyses of variance were performed to determine the training effects and the retention of training effects .
RESULTS	Participants in group A significantly increased knee flexion angles and decreased ground-reaction forces at the end of week 8 ( P .012 ) .
RESULTS	Participants in group B significantly increased knee flexion angles and decreased ground-reaction forces at the ends of weeks 4 and 8 ( P .007 ) .
RESULTS	However , participants in group B decreased knee flexion angles and increased ground-reaction forces at the end of week 8 in comparison with the end of week 4 ( P .009 ) .
CONCLUSIONS	Knee extension constraint training for 4 weeks significantly altered lower extremity movement patterns and transferred these changes in lower extremity movement patterns to stop-jump and side-cutting tasks in which ACL injuries frequently occur .
CONCLUSIONS	Training effects were retained 4 weeks after the training was completed but were diminished in magnitude .
CONCLUSIONS	A knee extension constraint device may be a useful training tool in future ACL injury prevention programs to alter movement patterns without extra training time .

###25112372
BACKGROUND	The risk of cardiovascular disease is tremendously high in dialysis patients .
BACKGROUND	Dialysis patients treated with vitamin D analogs show decreased cardiovascular morbidity and mortality compared with untreated patients .
BACKGROUND	We examined the influence of two common vitamin D analogs , alfacalcidol and paricalcitol , on important cardiovascular biomarkers in hemodialysis patients .
BACKGROUND	Anti-inflammatory effects and the influence on regulators of vascular calcification as well as markers of heart failure were examined .
METHODS	In 57 chronic hemodialysis patients enrolled in a randomized crossover trial comparing paricalcitol and alfacalcidol , we examined the changes in osteoprotegerin , fetuin-A , NT-proBNP , hs-Crp , IL-6 and TNF - , during 16weeks of treatment .
RESULTS	NT-proBNP and osteoprotegerin increased comparably in the paricalcitol and alfacalcidol-treated groups .
RESULTS	Fetuin-A increased significantly in the alfacalcidol-treated group compared with the paricalcitol-treated group ( difference 32.84 mol/l ( 95 % C.I. ; range 0.21-67 .47 ) ) during the first treatment period .
RESULTS	No difference was found between the groups during the second treatment period , and IL-6 , TNF - and hs-Crp were unchanged in both treatment groups .
CONCLUSIONS	Paricalcitol and alfacalcidol modulate regulators of vascular calcification .
CONCLUSIONS	Alfacalcidol may increase the level of the calcification inhibitor fetuin-A .
CONCLUSIONS	We did not find any anti-inflammatory effect or difference in changes of NT-proBNP .
BACKGROUND	ClinicalTrials.gov NCT00469599 May 3 2007 .

###25059094
BACKGROUND	Men with advanced prostate cancer ( APC ) undergoing androgen deprivation therapy ( ADT ) often experience distressing sexual side effects .
BACKGROUND	Sexual bother is an important component of adjustment .
BACKGROUND	Factors associated with increased bother are not well understood .
OBJECTIVE	This study sought to describe sexual dysfunction and bother in APC patients undergoing ADT , identify socio-demographic and health/disease-related characteristics related to sexual bother , and evaluate associations between sexual bother and psychosocial well-being and quality of life ( QOL ) .
METHODS	Baseline data of a larger psychosocial intervention study was used .
METHODS	Pearson 's correlation and independent samples t-test tested bivariate relations .
METHODS	Multivariate regression analysis evaluated relations between sexual bother and psychosocial and QOL outcomes .
METHODS	The Expanded Prostate Cancer Index Composite sexual function and bother subscales , Center for Epidemiologic Studies Depression Scale , Functional Assessment of Cancer Therapy -- General , and Dyadic Adjustment Scale were the main outcome measures .
RESULTS	Participants ( N = 80 ) were 70 years old ( standard deviation [ SD ] = 9.6 ) and reported 18.7 months ( SD = 17.3 ) of ADT .
RESULTS	Sexual dysfunction ( mean = 10.1 ; SD = 18.0 ) was highly prevalent .
RESULTS	Greater sexual bother ( lower scores ) was related to younger age ( = 0.25 , P = 0.03 ) and fewer months of ADT ( = 0.22 , P = 0.05 ) .
RESULTS	Controlling for age , months of ADT , current and precancer sexual function , sexual bother correlated with more depressive symptoms ( = -0.24 , P = 0.06 ) and lower QOL ( = 0.25 , P = 0.05 ) .
RESULTS	Contrary to hypotheses , greater sexual bother was related to greater dyadic satisfaction ( = -0.35 , P = 0.03 ) and cohesion ( = -0.42 , P = 0.01 ) .
CONCLUSIONS	The majority of APC patients undergoing ADT will experience sexual dysfunction , but there is variability in their degree of sexual bother .
CONCLUSIONS	Psychosocial aspects of sexual functioning should be considered when evaluating men 's adjustment to ADT effects .
CONCLUSIONS	Assessment of sexual bother may help identify men at risk for more general distress and lowered QOL .
CONCLUSIONS	Psychosocial interventions targeting sexual bother may complement medical treatments for sexual dysfunction and be clinically relevant , particularly for younger men and those first starting ADT .

###25545238
OBJECTIVE	To investigate the pharmacokinetic/pharmacodynamic ( PK/PD ) interaction between irbesartan ( IRB ) and hydrochlorothiazide ( HCT ) in normotensive subjects .
METHODS	A three-way crossover study was used .
METHODS	Serial drug concentrations and drug effects , including systolic and diastolic blood pressure and heart rate were monitored after administration of irbesartan and hydrochlorothiazide alone and in combination .
METHODS	The data were fitted to a PK/PD model and the parameters for irbesartan and hydrochlorothiazide when administered alone and in combination were compared .
RESULTS	The plasma profiles for irbesartan and hydrochlorothiazide followed the two-compartment model after a single dose .
RESULTS	The PK parameters of irbesartan were not affected by hydrochlorothiazide ; however irbesartan decreased the hydrochlorothiazide AUC by 25 % and increased its clearance by 25 % .
RESULTS	There were no significant changes in heart rate after each drug alone or in combination .
RESULTS	Irbesartan plus hydrochlorothiazide had a greater blood pressure lowering effect compared with irbesartan alone , despite the unchanged irbesartan PK .
RESULTS	The relationship between irbesartan plasma concentration and its effects plotted in chronological order showed anticlockwise hysteresis .
RESULTS	The PD parameter estimates for the effect of irbesartan on systolic blood pressure , when administered with hydrochlorothiazide were significantly different from those when irbesartan was administered alone .
RESULTS	This was manifested by a 25 % increase in Emax , and a 40 % decrease in EC50 , suggesting a synergistic blood pressure lowering effect for the combination .
RESULTS	While parameter estimates for the effect of irbesartan on diastolic blood pressure were changed by hydrochlorothiazide , the differences were only significant for EC50 .
CONCLUSIONS	A limited potential for clinically significant interactions between irbesartan and hydrochlorothiazide at the given doses were observed ; therefore , no dosage adjustments were recommended for either drug when used together .
CONCLUSIONS	( ClinicalTrials.gov Identifier NCT01858610 )

###24474180
OBJECTIVE	To investigate a saddle anesthesia with different doses of chloroprocaine in perianal surgery .
METHODS	Total 60 Patients aged 18-75 years ( Anesthesiologists grade I or II ) scheduled to receive perianal surgery .
METHODS	Patients using saddle anesthesia were randomized to group A , group B and group C with the same concentration ( 0.5 % ) chloroprocaine with different doses 1.0 mL , 0.8 mL and 0.6 mL , respectively .
METHODS	Systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , heart rate ( HR ) and the sensory and motor block were recorded to evaluate the anesthesia effect of chloroprocaine in each group .
RESULTS	The duration of sensory block of group C is shorter than those of group A and B.
RESULTS	The maximum degree of motor block is observed ( group C : 0 level , group A : III level ; and group B : I level ) after 15 minutes .
RESULTS	Besides , there was a better anesthetic effect in group B than group A and group C , such as walking after saddle anesthesia .
RESULTS	However , there is also no significant difference of blood pressure decreasing in these three groups .
CONCLUSIONS	It 's worth to employ a saddle anesthesia with appropriate doses of chloroprocaine in clinical perianal surgery .

###24310443
OBJECTIVE	Controlled somatosensory stimulation strategies have demonstrated merit in developing oral feeding skills in premature infants who lack a functional suck , however , the effects of orosensory entrainment stimulation on electrocortical dynamics is unknown .
OBJECTIVE	The objective of the study was to determine the effects of servo-controlled pneumatic orocutaneous stimulation presented during gavage feedings on the modulation of amplitude-integrated electroencephalogram ( aEEG ) and range electroencephalogram ( rEEG ) activity .
METHODS	Two-channel EEG recordings were collected during 180 sessions that included orocutaneous stimulation and non-stimulation epochs among 22 preterm infants ( mean gestational age = 28.56 weeks ) who were randomized to treatment and control ` sham ' conditions .
METHODS	The study was initiated at around 32 weeks post-menstrual age .
METHODS	The raw EEG was transformed into aEEG margins , and rEEG amplitude bands measured at 1-min intervals and subjected to a mixed models statistical analysis .
RESULTS	Multiple significant effects were observed in the processed EEG during and immediately following 3-min periods of orocutaneous stimulation , including modulation of the upper and lower margins of the aEEG , and a reorganization of rEEG with an apparent shift from amplitude bands D and E to band C throughout the 23-min recording period that followed the first stimulus block when compared with the sham condition .
RESULTS	Cortical asymmetry also was apparent in both EEG measures .
CONCLUSIONS	Orocutaneous stimulation represents a salient trigeminal input , which has both short - and long-term effects in modulating electrocortical activity , and thus is hypothesized to represent a form of neural adaptation or plasticity that may benefit the preterm infant during this critical period of brain maturation .

###24480179
OBJECTIVE	Impaired pulmonary gas exchange after cardiac surgeries with cardiopulmonary bypass ( CPB ) often occurs , and the selection of mechanical ventilation mode , pressure-controlled ventilation ( PCV ) or volume-controlled ventilation ( VCV ) , may be important for preventing hypoxia and improving oxygenation .
OBJECTIVE	The authors hypothesized that patients with PCV would show better oxygenation , compared with VCV , during one-lung ventilation ( OLV ) for mitral valve repair surgery ( MVP ) via thoracotomy .
METHODS	Randomized controlled trial .
METHODS	University teaching hospital .
METHODS	Sixty patients in each group .
METHODS	MVP was performed using thoracotomy with OLV by PCV or VCV .
RESULTS	Arterial partial pressure of oxygen ( PaO2 ) and fraction of inspired oxygen ( FIO2 ) were measured before anesthesia induction ( T0 ) , at skin incision ( T1 ) , after administration of heparin ( T2 ) , at 30 minutes after CPB weaning ( T3 ) , just before departure from the operating room to the intensive care unit ( ICU ) ( T4 ) , and 1 hour after ICU admission ( T5 ) , and PaO2/FIO2 ratio was calculated .
RESULTS	Peak inspiratory pressure ( PIP ) and mean inspiratory pressure ( Pmean ) were recorded at T1 , T2 , T3 , and T4 .
RESULTS	No significant difference was noted in the PaO2/FIO2 ratio between the groups at any measured point .
RESULTS	PIP in the PCV group at all measured points was lower than that in the VCV group ( T1 , p < 0.001 ; T2 , p < 0.001 ; T3 , p < 0.001 ; T4 , p = 0.025 , respectively ) .
RESULTS	Pmean was not different between the two groups at any measured point .
CONCLUSIONS	PCV during OLV in patients undergoing MVP via a thoracotomy with OLV showed lower PIP compared with VCV , but this did not improve pulmonary gas exchange .

###24460863
BACKGROUND	Currently available disease-modifying treatments acting by modifying the immune response are ineffective in progressive multiple sclerosis ( MS ) , which is caused by a widespread axonal degeneration .
BACKGROUND	Mechanisms suspected to be involved in this widespread axonal degeneration are reduced axonal energy metabolism , axonal glutamate toxicity , and reduced cerebral blood flow .
BACKGROUND	Fluoxetine might theoretically reduce axonal degeneration in MS because it stimulates energy metabolism through enhancing glycogenolysis , stimulates the production of brain-derived neurotrophic factor , and dilates cerebral arterioles .
BACKGROUND	The current document presents the protocol of a clinical trial to test the hypothesis that fluoxetine slows down the progressive phase of MS.
METHODS	The FLUOX-PMS trial is a multi-center , randomized , controlled and double-blind clinical study .
METHODS	A total of 120 patients with the diagnosis of either secondary or primary progressive MS will be treated either by fluoxetine ( 40 mg daily ) or placebo for a total period of 108 weeks .
METHODS	The primary endpoint is the time to confirmed disease progression defined as either at least a 20 % increase in the timed 25-Foot Walk or at least a 20 % increase in the 9-Hole Peg Test .
METHODS	Secondary endpoints include the Hauser ambulation index , cognitive changes , fatigue , magnetic resonance imaging of the brain , and in a small subgroup optical coherence tomography .
CONCLUSIONS	The FLUOX-PMS trial will gives us information as to whether fluoxetine has neuroprotective effects in patients with progressive MS.
BACKGROUND	Eudra-CT : 2011-003775-11 .

###24690159
BACKGROUND	The apolipoprotein A5 gene ( APOA5 ) -1131 T > C polymorphism is associated with mild hypertriglyceridemia in type 2 diabetic subjects , and interacts with dietary fat in the determination of triglyceride concentrations .
BACKGROUND	We examined whether a substitution of whole grains and legumes for refined rice in a high carbohydrate diet ( about 65 % of energy derived from carbohydrate ) may modify the effect of this variant on changes in apolipoprotein A-V ( apoA-V ) and triglyceride concentrations .
METHODS	We genotyped the APOA5 -1131 T > C in individuals with impaired fasting glucose ( IFG ) or newly diagnosed type 2 diabetes , who were randomly assigned to either a group ingesting whole grain and legume meals daily or a control group for 12weeks .
RESULTS	After dietary intervention , we observed significant interactions between the APOA5 -1131 T > C polymorphism and carbohydrate sources ( whole grains and legumes versus refined rice ) in the determination of mean percent changes in triglyceride and apoA-V ( P interactions < 0.001 and = 0.038 , respectively ) .
RESULTS	In the refined rice group ( n = 93 ) , the carriers of the risk C allele ( n = 50 ) showed a greater increase in the mean percent changes of triglyceride and apoA-V than noncarriers after adjusting for HOMA-IR ( P = 0.004 and 0.021 , respectively ) .
RESULTS	The whole grain and legume group ( n = 92 ) , however , showed a decrease in fasting glucose , HOMA-IR , and triglyceride , and an increase in apoA-V , irrespective of genotype .
CONCLUSIONS	The data showed that the magnitude of the genetic effect of the APOA5 -1131 C variant on triglyceride and apoA-V levels was modulated when substituting consumption of whole grains and legumes for refined rice as a carbohydrate source in IFG or diabetic subjects .
BACKGROUND	ClinicalTrials.gov : NCT01784952 .

###25541942
BACKGROUND	Most patients with facial scarring would value even a slight improvement in scar quality .
BACKGROUND	Botulinum toxin A is widely used to alleviate facial dynamic rhytides but is also believed to improve scar quality by reducing wound tension during healing .
BACKGROUND	The main objective was to assess the effect of Botulinum toxin on scars resultant from standardized upper lip wounds .
METHODS	In this double-blinded , randomized , vehicle-controlled , prospective clinical trial , 60 consecutive consenting adults undergoing cleft lip scar revision ( CLSR ) surgery between July 2010 and March 2012 were randomized to receive botulinum toxin A ( n = 30 ) or vehicle ( normal saline ; n = 30 ) injections into the subjacent orbicularis oris muscle immediately after wound closure .
METHODS	Scars were independently assessed at 6-months follow-up in blinded fashion using : Vancouver Scar Scale ( VSS ) , Visual Analogue Scale ( VAS ) and photographic plus ultrasound measurements of scar widths .
RESULTS	58 patients completed the trial .
RESULTS	All scar assessment modalities revealed statistically significantly better scars in the experimental than the vehicle-control group .
CONCLUSIONS	Quality of surgical upper lip scars , which are oriented perpendicular to the direction of pull of the underlying orbicularis oris muscle , is significantly improved by its temporary paralysis during wound healing .
BACKGROUND	ClinicalTrials.gov NCT01429402 .

###25811824
OBJECTIVE	Evaluate the utility of 2 electronic medical record ( EMR ) - linked , automated phone reminder interventions for improving adherence to cardiovascular disease medications .
METHODS	A 1-year , parallel arm , pragmatic clinical trial in which 21,752 adults were randomized to receive either usual care ( UC ) or 1 of 2 interventions in the form of interactive voice recognition calls-regular ( IVR ) or enhanced ( IVR + ) .
METHODS	The interventions used automated phone reminders to increase adherence to cardiovascular disease medications .
METHODS	The primary outcome was medication adherence ; blood pressure and lipid levels were secondary outcomes .
METHODS	The study took place in 3 large health maintenance organizations .
METHODS	We enrolled participants who were 40 years or older , had diabetes mellitus or atherosclerotic cardiovascular disease , and were suboptimally adherent .
METHODS	IVR participants received automated phone calls when they were due or overdue for a refill .
METHODS	IVR + participants received these phone calls , plus personalized reminder letters , live outreach calls , EMR-based feedback to their primary care providers , and additional mailed materials .
RESULTS	Both interventions significantly increased adherence to statins and angiotensin-converting enzyme inhibitors/angiotensin receptor blockers ( ACEIs/ARBs ) compared with UC ( 1.6 to 3.7 percentage points ) .
RESULTS	Adherence to ACEIs/ARBs was also significantly higher for IVR + relative to IVR participants .
RESULTS	These differences persisted across subgroups .
RESULTS	Among statin users , IVR + participants had significantly lower low-density lipoprotein ( LDL ) levels at follow-up compared with UC ( = -1.5 ; 95 % CI , -2.7 to -0.2 mg/dL ) ; this effect was seen mainly in those with baseline LDL levels 100 mg/dL ( = -3.6 ; 95 % CI , -5.9 to -1.3 mg/dL ) .
CONCLUSIONS	Technology-based tools , in conjunction with an EMR , can improve adherence to chronic disease medications and measured cardiovascular disease risk factors .

###24495883
BACKGROUND	Ischaemia-reperfusion injury following acute myocardial infarctions ( AMI ) is an unavoidable consequence of the primary percutaneous coronary intervention ( pPCI ) procedure .
BACKGROUND	A pivotal mechanism in ischaemia-reperfusion injury is the production of reactive oxygen species following reperfusion .
BACKGROUND	The endogenous hormone , melatonin , works as an antioxidant and could potentially minimise the ischaemia-reperfusion injury .
BACKGROUND	Given intracoronarily , it enables melatonin to work directly at the site of reperfusion .
BACKGROUND	We wish to test if melatonin , as an antioxidant , can minimise the reperfusion injury following pPCI in patients with AMI .
METHODS	The IMPACT trial is a multicentre , randomised , double-blinded , placebo-controlled study .
METHODS	We wish to include 2 20 patients with ST-elevation myocardial infarctions undergoing pPCI within six hours from symptom onset .
METHODS	The primary end-point is the Myocardial Salvage Index assessed by cardiovascular magnetic resonance imaging on day 4 ( 1 ) after pPCI .
METHODS	The secondary end-points are high-sensitivity troponin , creatinekinase myocardial band and clinical events .
CONCLUSIONS	The aim of the IMPACT trial is to evaluate the effect of melatonin on reperfusion injuries following pPCI .
CONCLUSIONS	Owing to its relatively non-toxic profile , melatonin is an easily implementable drug in the clinical setting , and melatonin has the potential to reduce morbidity in patients with AMI .
BACKGROUND	This study received no financial support from the industry .
BACKGROUND	www.clinicaltrials.gov , clinical trials identifier : NCT01172171 .

###24670677
BACKGROUND	The public typically believes psychotherapy to be more effective than pharmacotherapy for depression treatments .
BACKGROUND	This is not consistent with current scientific evidence , which shows that both types of treatment are about equally effective .
OBJECTIVE	The study investigates whether this bias towards psychotherapy guides online information search and whether the bias can be reduced by explicitly providing expert information ( in a blog entry ) and by providing tag clouds that implicitly reveal experts ' evaluations .
METHODS	A total of 174 participants completed a fully automated Web-based study after we invited them via mailing lists .
METHODS	First , participants read two blog posts by experts that either challenged or supported the bias towards psychotherapy .
METHODS	Subsequently , participants searched for information about depression treatment in an online environment that provided more experts ' blog posts about the effectiveness of treatments based on alleged research findings .
METHODS	These blogs were organized in a tag cloud ; both psychotherapy tags and pharmacotherapy tags were popular .
METHODS	We measured tag and blog post selection , efficacy ratings of the presented treatments , and participants ' treatment recommendation after information search .
RESULTS	Participants demonstrated a clear bias towards psychotherapy ( mean 4.53 , SD 1.99 ) compared to pharmacotherapy ( mean 2.73 , SD 2.41 ; t173 = 7.67 , P < .001 , d = 0.81 ) when rating treatment efficacy prior to the experiment .
RESULTS	Accordingly , participants exhibited biased information search and evaluation .
RESULTS	This bias was significantly reduced , however , when participants were exposed to tag clouds with challenging popular tags .
RESULTS	Participants facing popular tags challenging their bias ( n = 61 ) showed significantly less biased tag selection ( F2 ,168 = 10.61 , P < .001 , partial eta squared = 0.112 ) , blog post selection ( F2 ,168 = 6.55 , P = .002 , partial eta squared = 0.072 ) , and treatment efficacy ratings ( F2 ,168 = 8.48 , P < .001 , partial eta squared = 0.092 ) , compared to bias-supporting tag clouds ( n = 56 ) and balanced tag clouds ( n = 57 ) .
RESULTS	Challenging ( n = 93 ) explicit expert information as presented in blog posts , compared to supporting expert information ( n = 81 ) , decreased the bias in information search with regard to blog post selection ( F1 ,168 = 4.32 , P = .04 , partial eta squared = 0.025 ) .
RESULTS	No significant effects were found for treatment recommendation ( Ps > .33 ) .
CONCLUSIONS	We conclude that the psychotherapy bias is most effectively attenuated-and even eliminated-when popular tags implicitly point to blog posts that challenge the widespread view .
CONCLUSIONS	Explicit expert information ( in a blog entry ) was less successful in reducing biased information search and evaluation .
CONCLUSIONS	Since tag clouds have the potential to counter biased information processing , we recommend their insertion .

###24313178
OBJECTIVE	Several combined spinal-epidural ( CSE ) anesthesia techniques have been described .
OBJECTIVE	This study was designed to compare the single space ( `` needle-through-needle '' ) technique ( SST ) and the double distant space technique ( DDS ) with regards to the time needed for the procedure , patient discomfort during the procedure and patient 's preference technique .
METHODS	This prospective , randomized single-blind study included 156 patients undergoing colorectal surgery under general anesthesia and CSE .
METHODS	All neuraxial blocks were performed before general anesthesia induction .
METHODS	DDS group of patients had thoracic epidural catheter placed at T6-7 or T7-8 , followed by subarachnoid injection at the L2-3 interspace .
METHODS	The SST group of patients had a single injection using the needle-through-needle technique ( Espocan needle ) at L2-3 .
METHODS	The epidural catheter was used for postoperative analgesia for 72 hours .
METHODS	Body habitus , spinal anatomy and spinal landmarks were assessed preoperatively .
METHODS	The number of epidural and spinal punctures , the feeling that the dura is perforated ( dural perforation click ) and the time needed to perform CSE were also recorded .
METHODS	Complications during epidural catheter placement and perioperative and postoperative epidural catheter function and patient preference for the anesthetic procedure were recorded .
RESULTS	Epidural and subarachnoid spaces were successfully identified in all the patients .
RESULTS	Duration of CSE procedure , the number of spinal punctures , dural click feeling and the effects of test dose did not differ between the groups .
RESULTS	The patients in both groups ( 90 % of DDS and 87 % of SST ) would choose CSE as preferred method in the future .
RESULTS	The CSE procedure was painful for 16 % of DDS vs 20 % of SST patients .
RESULTS	A significant correlation between time needed for CSE technique performance and body habitus ( r = 0.338 , p < 0.01 ) , spinal landmarks ( r = 0.452 , p < 0.001 ) and anatomy ( r = 0.265 , p < 0.05 ) was found in the SST group .
RESULTS	There was no correlation between the number of epidural/spinal punctures and epidural bacteriological findings .
RESULTS	There was no correlation between the patients ' choice of the CSE technique and the number of spinal punctures , duration of CSE procedure and epidural catheter stay .
CONCLUSIONS	The two CSE techniques did not differ with regards to the procedure time and patient 's preference .
CONCLUSIONS	Procedure time correlated with body habitus , spinal landmarks and the anatomy in the SST group .

###25371291
OBJECTIVE	To assess the effect of analgesia at disbudding on weight gain and milk intake of dairy calves .
METHODS	Four disbudding protocols were used on 3 - to 6-week-old Friesian-Jersey calves .
METHODS	Farm staff disbudded 101 calves without sedation or local analgesia , of which 51 received 20mg meloxicam S/C .
METHODS	Veterinary staff disbudded 101 calves with sedation and local analgesia , of which 51 also received 20mg meloxicam S/C .
METHODS	Calves were weighed before disbudding , 15 and 30 days later , and individual milk consumption was recorded for 11 days .
METHODS	Daily weight gain and milk consumption were analysed using mixed models and ANOVA .
RESULTS	From disbudding ( Day 0 ) to Day 15 farmer-disbudded calves receiving meloxicam grew faster ( 0.65 kg/day ) than calves without meloxicam ( 0.55 kg/day ; p = 0.011 ) , but an interaction between operator and meloxicam treatment ( p = 0.056 ) meant that meloxicam treatment did not increase growth rates in veterinary-disbudded calves ( 0.63 vs. 0.64 kg/day ; p = 0.872 ) .
RESULTS	From Days 16-30 there was no significant effect of meloxicam on growth rate , but veterinarian-disbudded calves grew faster ( 0.76 kg/day ) than farmer-disbudded calves ( 0.66 kg/day ; p = 0.034 ) .
RESULTS	Overall , for the first 30 days after disbudding , if meloxicam was not used ' , veterinarian-disbudded calves grew faster than farmer-disbudded calves ( p = 0.002 ) .
RESULTS	However if meloxicam was used at disbudding there was no difference in growth rate between veterinarian - and farmer-disbudded calves ( p = 0.878 ) .
RESULTS	Mean cumulative milk consumption for the 11 days after disbudding was greater for calves disbudded by veterinary staff than by farm staff ( p < 0.001 ) , but there was no effect of meloxicam treatment ( p = 0.618 ) and no interaction with operator ( p = 0.86 ) on cumulative milk consumption .
CONCLUSIONS	Three to 6-week-old dairy calves disbudded by farm staff with no analgesia grew significantly slower over the next 15 days than farmer-disbudded calves given meloxicam , and slower over the next 30 days than veterinarian-disbudded calves given xylazine and lignocaine .
CONCLUSIONS	However addition of meloxicam to the latter protocol had no effect on growth rate .
CONCLUSIONS	Milk intake was significantly higher for 11 days for veterinarian - compared with farmer-disbudded calves .
CONCLUSIONS	This study adds to the evidence that analgesia during disbudding is beneficial for calf productivity as well as calf welfare .

###25065086
OBJECTIVE	The double balloon enteroscopy ( DBE ) procedure is long and requires moderate sedation .
OBJECTIVE	We aim to determine whether the administration of propofol infusion is safe by comparing it to intravenous midazolam/meperidine in patients undergoing DBE .
METHODS	A prospective study with 48 patients was conducted at King Chulalongkorn Hospital randomizing ( block of four ) patients into two groups .
METHODS	In group 1 , 28 patients were enrolled for intravenous midazolam/meperidine , and one patient was dropped out before underwent DBE due to hemodynamic instability .
METHODS	Therefore , 27 ( n = 27 ) participants were included in Group 1 .
METHODS	In group 2 , 28 patients were enrolled for propofol infusion , and seven patients were dropped out before underwent DBE , five due to hemodynamic instability ( n = 5 ) , and two refused treatment ( n = 2 ) .
METHODS	Therefore , 1 ( n = 21 ) participants were included in Group 2 .
METHODS	Vital signs and oxygen saturation were regularly monitored .
RESULTS	Mean + / - SD age of patients was 56.8 + / - 9.2 years , and 41.7 % of patients were male .
RESULTS	There was no difference in demographic data between the groups .
RESULTS	For the safety profile , 25.9 % of the midazolam/meperidine group and 33.3 % of the propofol group developed hypotension and/or desaturation ( p = 0.45 ) .
RESULTS	The patients ' satisfaction of group 1 and group 2 were 86.7 + / - 6.5 % and 86.3 + / - 8.1 % , respectively , and presented no significant difference ( p = 0.89 ) .
CONCLUSIONS	Propofol infusion is safe and shows no difference in outcome from the midazolam and meperidine sedation for the DBE procedure .

###25518508
OBJECTIVE	To evaluate the efficacy of cytoflavin in the treatment of patients with hypertensive encephalopathy ( HE ) .
METHODS	One hundred and forty patients aged 39 to 73 years , diagnosed with HE , were examined and randomized to 2 groups .
METHODS	A study group ( n = 74 ) received cytoflavin in a dose of 2 tablets b.i.d. on days 1 to 25 days inclusive during standard basic therapy .
METHODS	A comparison group ( n = 66 persons ) had standard basic therapy only .
METHODS	A control group consisted of 30 apparently healthy individuals .
METHODS	The investigators studied the frequency of headache , dizziness , and other complaints and the intensity of cephalalgic syndrome , by using a visual analog scale , the quality of life by the Medical Outcomes Study 36-Item Short-Form Health Survey ( MOS SF-36 ) questionnaire , that of sleep by the subjective sleep characteristics questionnaire elaborated at the Moscow City Somnological Center , the level of asthenia by a subjective asthenia rating scale ( Multidimensional Fatigue Inventory ( MFI-20 ) , and autonomic status , by applying objective and subjective scales on days 1 and 25 of therapy .
RESULTS	The study has shown that cytoflavin used in the above dose for 25 days reduces the frequency and magnitude of complaints of headache , dizziness , `` venous '' complaints , the degree of autonomic and asthenic disorders , and impairments in the quality of sleep and life in the patients with HE at all disease stages .
RESULTS	A stepwise discriminant analysis has indicated that the degree of cephalgic syndrome , and autonomic disorders , and worse sleep quality are the most effective points for using the energy-modifier cytoflavin .
CONCLUSIONS	HE treatment based on the current pathogenetic principles may have a preventive impact on the development of HE or slow down the rate of its progression .

###24680359
BACKGROUND	Local failure after radical prostatectomy ( RP ) is common in patients with cancer extending beyond the capsule .
BACKGROUND	Three prospectively randomized trials demonstrated an advantage for adjuvant radiotherapy ( ART ) compared with a wait-and-see ( WS ) policy .
OBJECTIVE	To determine the efficiency of ART after a 10-yr follow-up in the ARO 96-02 study .
METHODS	After RP , 388 patients with pT3 pN0 prostate cancer ( PCa ) were randomized to WS or three-dimensional conformal ART with 60 Gy .
METHODS	The present analysis focuses on intent-to-treat patients who achieved an undetectable prostate-specific antigen after RP ( ITT2 population ) -- that is , 159 WS plus 148 ART men .
METHODS	The primary end point of the study was progression-free survival ( PFS ) ( events : biochemical recurrence , clinical recurrence , or death ) .
METHODS	Outcomes were compared by log-rank test .
METHODS	Cox regression analysis served to identify variables influencing the course of disease .
CONCLUSIONS	The median follow-up was 111 mo for ART and 113 mo for WS .
CONCLUSIONS	At 10 yr , PFS was 56 % for ART and 35 % for WS ( p < 0.0001 ) .
CONCLUSIONS	In pT3b and R1 patients , the rates for WS even dropped to 28 % and 27 % , respectively .
CONCLUSIONS	Of all 307 ITT2 patients , 15 died from PCa , and 28 died for other or unknown reasons .
CONCLUSIONS	Neither metastasis-free survival nor overall survival was significantly improved by ART .
CONCLUSIONS	However , the study was underpowered for these end points .
CONCLUSIONS	The worst late sequelae in the ART cohort were one grade 3 and three grade 2 cases of bladder toxicity and two grade 2 cases of rectum toxicity .
CONCLUSIONS	No grade 4 events occurred .
CONCLUSIONS	Compared with WS , ART reduced the risk of ( biochemical ) progression with a hazard ratio of 0.51 in pT3 PCa .
CONCLUSIONS	With only one grade 3 case of late toxicity , ART was safe .
RESULTS	Precautionary radiotherapy counteracts relapse after surgery for prostate cancer with specific risk factors .

###25175696
OBJECTIVE	The aim of this work was to assess the prognostic value of absolute N-terminal-pro-B-type natriuretic peptide ( NT-proBNP ) concentration in combination with changes during admission because of acute heart failure ( AHF ) and early after hospital discharge .
BACKGROUND	In AHF , readmission and mortality rates are high .
BACKGROUND	Identifying those at highest risk for events early after hospital discharge might help to select patients in need of intensive outpatient monitoring .
RESULTS	We evaluated the prognostic value of NT-proBNP concentration on admission , at discharge , 1month after hospital discharge and change over time in 309 patients included in the PRIMA ( Can PRo-brain-natriuretic peptide guided therapy of chronic heart failure IMprove heart fAilure morbidity and mortality ? )
RESULTS	study .
RESULTS	Primary outcome measures were mortality and the combined end point of heart failure ( HF ) readmission or mortality .
RESULTS	In a multivariate Cox regression analysis , change in NT-proBNP concentration during admission , change from discharge to 1month after discharge , and the absolute NT-proBNP concentration at 1 month after discharge were of independent prognostic value for both end points ( hazard ratios for HF readmission or mortality : 1.71 , 95 % confidence interval [ CI ] 1.13-2 .60 , Wald 6.4 [ P = .011 ] versus 2.71 , 95 % CI 1.76-4 .17 , Wald 20.5 [ P < .001 ] versus 1.81 , 95 % CI 1.13-2 .89 , Wald 6.1 [ P = .014 ] , respectively .
CONCLUSIONS	Knowledge of change in NT-proBNP concentration during admission because of AHF in combination with change early after discharge and the absolute NT-proBNP concentration at 1 month after discharge allows accurate risk stratification .

###24838360
BACKGROUND	Three trials demonstrated recently that a long detection window reduces implantable cardioverter-defibrillator ( ICD ) therapy in primary prevention patients .
BACKGROUND	Avoid Delivering Therapies for Nonsustained Arrhythmias in ICD Patients III ( ADVANCE III ) was the only trial that enrolled both primary and secondary prevention patients .
RESULTS	Of the 1902 patients enrolled in the ADVANCE III trial , 477 received a defibrillator for secondary prevention ; 248 patients were randomly assigned to a long detection setting ( 30 of 40 intervals ) and 229 to the nominal setting ( 18 of 24 intervals ) for ventricular arrhythmias with cycle length 320 ms. Eight-five percent of patients were men , with a mean age of 65 12 years , a previous history of ventricular fibrillation in 37 % of the cases , and a mean ejection fraction of 38 13 % .
RESULTS	The ICD device mix was 37 % single chamber , 47 % dual chamber , and 16 % triple chamber .
RESULTS	Over a median period of 12 months , the long detection period was associated with a 25 % reduction in the number of overall therapies ( 115.6 versus 86.8 per 100 patient-years ; incidence rate ratio , 0.75 ; 95 % confidence interval , 0.61-0 .93 ; P = 0.008 ) and a 34 % reduction in the number of shocks ( rate per 100 patient-years , 51.2 versus 38.1 ; incidence rate ratio , 0.66 ; 95 % confidence interval , 0.48-0 .89 ; P = 0.007 ) .
RESULTS	Appropriate therapies ( 89.7 versus 67.7 ; incidence rate ratio , 0.77 ; 95 % confidence interval , 0.60-0 .97 ; P = 0.029 ) and appropriate shocks ( 37.1 versus 28.1 ; incidence rate ratio , 0.64 ; 95 % confidence interval , 0.45-0 .93 ; P = 0.018 ) were also reduced .
CONCLUSIONS	ADVANCE III is the first randomized trial to assess a long detection window setting in ICDs in both primary and secondary prevention populations and demonstrates a reduction of overall therapies and shocks in the subgroup of secondary prevention patients .
CONCLUSIONS	These data suggest that even the secondary prevention population may benefit from programming that combines a long detection period with antitachycardia pacing during charging .
BACKGROUND	http://www/clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00617175 .

###24384657
METHODS	Prospective , double-blind study , randomized control trial .
OBJECTIVE	To evaluate and compare the analgesic efficacy , adverse effects , and clinical utility of gabapentin and pregabalin in postoperative pain management , long-term functional outcome , and quality of life in patients undergoing spinal surgery .
BACKGROUND	Patient outcome after lumbar discectomy for radicular low back pain is variable and the benefit is inconsistent .
BACKGROUND	The most common persistent symptoms are pain , motor deficit , and decreased functional status .
METHODS	This study was conducted in 90 patients belonging to the 18 to 75 age group of either sex undergoing spinal surgery under general anesthesia .
METHODS	Group A received 300 mg of gabapentin , group B received 75 mg of pregabalin , whereas group C received placebo 1 dose 1 hour before surgery and 8 hourly for 7 days , thereafter .
METHODS	The outcome of postoperative static and dynamic pain and functional outcome was recorded using 3 questionnaires-visual analogue scale , Prolo functional and economic score , Oswestry Disability Index score from preoperative period to 3 months postoperatively .
RESULTS	Among the 3 groups , subjects receiving pregabalin showed consistently reduced static and dynamic pain intensity and also required lesser amount of rescue drug throughout the postoperative period .
RESULTS	There was statistically significant difference ( P < 0.05 ) in the Prolo score and Oswestry Disability Index score at all time intervals between group B and group C. Although , significant difference in the functional outcome between group A and group B was seen at 3 months .
CONCLUSIONS	Preoperative pregabalin administration is associated with less pain intensity and improved functional outcomes 3 months after lumbar discectomy followed by gabapentin and then placebo .
METHODS	2 .

###24509214
BACKGROUND	Limited data exist regarding the proarrhythmic effects of smoking .
OBJECTIVE	To evaluate the relationship between smoking and the risk of first and recurrent ventricular tachyarrhythmias ( VTAs ) in patients with mild heart failure .
METHODS	The risk of a first and recurrent appropriate implantable cardioverter-defibrillator therapy for VTAs or death was compared between nonsmokers ( n = 465 ) , past smokers ( n = 780 ) , and current smokers ( n = 197 ) in patients with ischemic and nonischemic cardiomyopathy who were enrolled in the Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy study .
RESULTS	The cumulative probability of a first VTA or death was significantly higher in current smokers than in past and nonsmokers ( P < .001 ) .
RESULTS	Multivariate analysis showed that current smokers had a significantly higher risk of first ventricular tachycardia/ventricular fibrillation or death ( hazard ratio [ HR ] 1.51 ; 95 % confidence interval [ CI ] 1.14-2 .01 ; P = .005 ) and a higher risk for first ventricular tachycardia/ventricular fibrillation episode ( HR 1.54 , 95 % CI 1.12-2 .13 , P = .008 ) than did nonsmokers .
RESULTS	Past smokers had a risk of first VTAs or death similar to that of nonsmokers ( HR 1.01 ; 95 % CI 0.80-1 .27 ; P = .953 ) .
RESULTS	In comparison to nonsmokers , the risk of recurrent VTAs was significantly higher in the total cohort of patients ( HR 1.54 ; 95 % CI 1.21-1 .95 ; P < .001 ) and in the subgroups of patients with ischemic and nonischemic cardiomyopathy ( HR 1.48 ; 95 % CI 1.03-2 .13 ; P = .035 ) .
CONCLUSIONS	Current smokers with left ventricular dysfunction and mild heart failure are at a significantly higher risk of VTAs or death than are past smokers and nonsmokers .
CONCLUSIONS	Smoking is associated with a significant increase in the risk of recurrent VTAs in both patients with ischemic and nonischemic cardiomyopathy .

###25468084
BACKGROUND	Refining leaflet reconstruction has become a primary issue in aortic valve repair .
BACKGROUND	This descriptive analysis reviews leaflet pathology , repair techniques , and early results in a prospective regulatory trial of aortic valve repair .
METHODS	Sixty-five patients underwent valve repair for predominant moderate to severe aortic insufficiency ( AI ) .
METHODS	The mean age was 63 13 years , and 69 % of the patients were male .
METHODS	Ascending aortic/root replacement was required in 62 % .
METHODS	As a first step , ring annuloplasty was performed , and then leaflet repair included leaflet plication for prolapse , nodular unfolding , double pericardial patching of commissural defects or holes , complete pericardial leaflet replacement , leaflet extension , and Gore-Tex reinforcement .
METHODS	Leaflet techniques and causes of adverse outcomes were evaluated .
RESULTS	The follow-up time was 2-years maximal and 0.9 years mean , with a survival of 97 % .
RESULTS	Eighty percent of patients required repair of leaflet defects : leaflet prolapse ( 52/65-80 % ) , ruptured commissures ( 6/65 -9 % ) , leaflet holes ( 4/65 -6 % ) , and nodular retraction ( 6/65 -9 % ) .
RESULTS	The average preoperative AI grade of 2.9 0.8 fell to 0.7 0.7 ( p < 0.0001 ) .
RESULTS	Three patients ( 4.6 % ) required interval valve replacement because of ( 1 ) suture untying , ( 2 ) iatrogenic leaflet tear , or ( 3 ) diphtheroid endocarditis .
RESULTS	Five other patients experienced grade 2 or grade 3 AI : probable suture untying in 1patient , ineffective leaflet extensions in 2 patients , and unsuccessful Gore-Tex reinforcements in2patients .
RESULTS	Two patients with single pericardial leaflet replacements and all those with double pericardial reconstructions did well .
CONCLUSIONS	Leaflet defects are common in patients with moderate to severe AI .
CONCLUSIONS	Leaflet plication , nodular unfolding , and double pericardial patching performed well .
CONCLUSIONS	Gore-Tex and leaflet extension seemed less satisfactory .
CONCLUSIONS	Standardization and experience with leaflet reconstruction will be important for optimizing the outcomes of aortic valve repair .

###24368354
BACKGROUND	We hypothesize that limited transthoracic echocardiogram ( LTTE ) is a useful tool to guide therapy during the initial phase of resuscitation in trauma patients .
METHODS	All highest-level alert patients with at least one measurement of systolic blood pressure less than 100 mm Hg , a mean arterial pressure less than 60 mm Hg , and/or a heart rate greater than 120 beats per minute who arrived to the trauma bay ( TB ) were randomized to have either LTTE performed ( LTTEp ) or not performed ( non-LTTE ) as part of their initial evaluation .
METHODS	Images were stored , and results were reported regarding contractility ( good vs. poor ) , fluid status ( empty inferior vena cava [ hypovolemic ] vs. full inferior vena cava [ not hypovolemic ] ) , and pericardial effusion ( present vs. absent ) .
METHODS	Time from TB to operating room , intravenous fluid administration , blood product requirement , intensive care unit admission , and mortality were examined in both groups .
RESULTS	A total of 240 patients were randomized .
RESULTS	Twenty-five patients were excluded since they died upon arrival to the TB , leaving 215 patients in the study .
RESULTS	Ninety-two patients were in the LTTEp group with 123 patients in the non-LTTE group .
RESULTS	The LTTEp and non-LTTE groups were similar in age ( 38 years vs. 38.8 years , p = 0.75 ) , Injury Severity Score ( ISS ) ( 19.2 vs. 19.0 , p = 0.94 ) , Revised Trauma Score ( RTS ) ( 5.5 vs. 6.0 , p = 0.09 ) , lactate ( 4.2 vs. 3.6 , p = 0.14 ) , and mechanism of injury ( p = 0.44 ) .
RESULTS	Strikingly , LTTEp had significantly less intravenous fluid than non-LTTE patients ( 1.5 L vs. 2.5 L , p < 0.0001 ) , less time from TB to operating room ( 35.6 minutes vs. 79.1 min , p = 0.0006 ) , higher rate of intensive care unit admission ( 80.4 % vs. 67.2 % , p = 0.04 ) , and a lower mortality rate ( 11 % vs. 19.5 % , p = 0.09 ) .
RESULTS	Mortality differences were particularly evident in the traumatic brain injury patients ( 14.7 % in LTTEp vs. 39.5 % in non-LTTE , p = 0.03 ) .
CONCLUSIONS	LTTE is a useful guide for therapy in hypotensive trauma patients during the early phase of resuscitation .
METHODS	Therapeutic study , level II .

###24786946
BACKGROUND	Our goal is to conduct a multicenter randomized controlled trial ( RCT ) to investigate whether exercise can reduce incident fractures compared with no intervention among women aged 65 years with a vertebral fracture .
OBJECTIVE	This pilot study will determine the feasibility of recruitment , retention , and adherence for the proposed trial .
METHODS	The proposed RCT will be a pilot feasibility study with 1:1 randomization to exercise or attentional control groups .
METHODS	Five Canadian sites ( 1 community hospital partnered with an academic center and 4 academic hospitals or centers affiliated with an academic center ) and 2 Australian centers ( 1 academic hospital and 1 center for community primary care , geriatric , and rehabilitation services ) .
METHODS	One hundred sixty women aged 65 years with vertebral fracture at 5 Canadian and 2 Australian centers will be recruited .
METHODS	The Build Better Bones With Exercise ( B3E ) intervention includes exercise and behavioral counseling , delivered by a physical therapist in 6 home visits over 8 months , and monthly calls ; participants are to exercise 3 times weekly .
METHODS	Controls will receive equal attention .
METHODS	Primary outcomes will include recruitment , retention , and adherence .
METHODS	Adherence to exercise will be assessed via calendar diary .
METHODS	Secondary outcomes will include physical function ( lower extremity strength , mobility , and balance ) , posture , and falls .
METHODS	Additional secondary outcomes will include quality of life , pain , fall self-efficacy , behavior change variables , intervention cost , fractures , and adverse events .
METHODS	Analyses of feasibility objectives will be descriptive or based on estimates with 95 % confidence intervals , where feasibility will be assessed relative to a priori criteria .
METHODS	Differences in secondary outcomes will be evaluated in intention-to-treat analyses via independent Student t tests , chi-square tests , or logistic regression .
METHODS	The Bonferroni method will be used to adjust the level of significance for secondary outcomes so the overall alpha level is .05 .
CONCLUSIONS	No assessment of bone mineral density will be conducted .
CONCLUSIONS	The proposed definitive trial will require a large sample size .
CONCLUSIONS	The viability of a large-scale exercise trial in women with vertebral fractures will be evaluated , as well as the effects of a home exercise program on important secondary outcomes .

###25204404
OBJECTIVE	Abiraterone acetate , an androgen biosynthesis inhibitor , prolongs survival in men with metastatic castration-resistant prostate cancer ( mCRPC ) in the pre - and post-chemotherapy setting as demonstrated by the pivotal phase III studies COU-AA-301 and COU-AA-302 .
OBJECTIVE	We performed population pharmacokinetic analyses to estimate pharmacokinetic parameters after oral administration of 1,000 mg/day of abiraterone acetate in patients with mCRPC , with or without prior chemotherapy , and after a single 1,000 mg dose in healthy volunteers .
OBJECTIVE	The study objectives were to determine consistency between patient populations and to characterize factors that may influence abiraterone pharmacokinetics .
METHODS	Studies in this analysis included COU-AA-302 ( chemotherapy nave ) ; COU-AA-301 and COU-AA-006 ( chemotherapy pretreated ) ; and COU-AA-008 , COU-AA-009 , and COU-AA-014 ( healthy subjects ) .
METHODS	A total of 4,627 plasma concentrations from 359 subjects ( 62 healthy volunteers , 297 patients ) were analyzed using non-linear mixed-effects modeling .
RESULTS	An Erlang-type absorption model with first-order elimination and three-transit compartments following sequential zero - and first-order processes was used to characterize abiraterone pharmacokinetics .
RESULTS	Absorption-related parameters were affected by food intake .
RESULTS	Abiraterone pharmacokinetics were characterized by an extensive apparent clearance , which was lower in patients with mCRPC ( 1,550 L/h ) versus healthy subjects ( 2,240 L/h ) , and by large apparent central ( 5,620 L ) and peripheral ( 17,400 L ) volumes of distribution .
RESULTS	Abiraterone pharmacokinetics were similar in chemotherapy-pretreated and - nave patients and were characterized by a high between - and within-subject variability [ e.g. , between-subject coefficient of variation ( CV % ) for relative bioavailability for the modified fasting state was 61.1 % and the CV % for within-subject variability was 71.3 % ] .
RESULTS	The fat content of food taken with abiraterone acetate affected the bioavailability of abiraterone .
RESULTS	No factors beyond food intake and health status ( healthy vs. mCRPC ) impacted abiraterone pharmacokinetics .
CONCLUSIONS	Based on the pharmacokinetics model , the recommended 1,000 mg/day of abiraterone acetate resulted in similar abiraterone exposure for patients with mCRPC regardless of prior chemotherapy .
CONCLUSIONS	The fat content of food affected relative bioavailability of abiraterone , though the extent of this effect is dependent on health status .

###25992505
BACKGROUND	The appropriate caloric goal for critically ill adults is unclear .
BACKGROUND	We evaluated the effect of restriction of nonprotein calories ( permissive underfeeding ) , as compared with standard enteral feeding , on 90-day mortality among critically ill adults , with maintenance of the full recommended amount of protein in both groups .
METHODS	At seven centers , we randomly assigned 894 critically ill adults with a medical , surgical , or trauma admission category to permissive underfeeding ( 40 to 60 % of calculated caloric requirements ) or standard enteral feeding ( 70 to 100 % ) for up to 14 days while maintaining a similar protein intake in the two groups .
METHODS	The primary outcome was 90-day mortality .
RESULTS	Baseline characteristics were similar in the two groups ; 96.8 % of the patients were receiving mechanical ventilation .
RESULTS	During the intervention period , the permissive-underfeeding group received fewer mean ( SD ) calories than did the standard-feeding group ( 835297 kcal per day vs. 1299467 kcal per day , P < 0.001 ; 4614 % vs. 7122 % of caloric requirements , P < 0.001 ) .
RESULTS	Protein intake was similar in the two groups ( 5724 g per day and 5925 g per day , respectively ; P = 0.29 ) .
RESULTS	The 90-day mortality was similar : 121 of 445 patients ( 27.2 % ) in the permissive-underfeeding group and 127 of 440 patients ( 28.9 % ) in the standard-feeding group died ( relative risk with permissive underfeeding , 0.94 ; 95 % confidence interval [ CI ] , 0.76 to 1.16 ; P = 0.58 ) .
RESULTS	No serious adverse events were reported ; there were no significant between-group differences with respect to feeding intolerance , diarrhea , infections acquired in the intensive care unit ( ICU ) , or ICU or hospital length of stay .
CONCLUSIONS	Enteral feeding to deliver a moderate amount of nonprotein calories to critically ill adults was not associated with lower mortality than that associated with planned delivery of a full amount of nonprotein calories .
CONCLUSIONS	( Funded by the King Abdullah International Medical Research Center ; PermiT Current Controlled Trials number , ISRCTN68144998 . )

###25047497
OBJECTIVE	Lobeglitazone , a peroxisome proliferator-activated receptor - agonist , is metabolized primarily by the cytochrome P450 ( CYP ) 3A4 isoenzyme .
OBJECTIVE	Individuals concomitantly taking lobeglitazone and a CYP3A4 inhibitor may experience some adverse effects secondary to increased systemic exposure to lobeglitazone .
OBJECTIVE	To address such potential concern , we evaluated the effects of ketoconazole , a prototypic CYP3A4 inhibitor , on the pharmacokinetic ( PK ) properties and associated adverse effects of lobeglitazone .
METHODS	A PK drug-drug interaction study was conducted in healthy individuals between 20 and 45 years old in a randomized , open-label , 2-way crossover design .
METHODS	Even though the PK study was performed on a single dose of lobeglitazone , multiple ketoconazole doses were given to ensure that the full extent of inhibition of CYP3A4 was maintained during the PK sampling .
METHODS	All study participants received a single oral dose of lobeglitazone 0.5 mg with or without 9 oral 200-mg doses of ketoconazole pretreatment twice daily .
METHODS	The primary PK parameter end points ( AUC and Cmax ) were estimated using noncompartmental analysis , and the 90 % CIs for the geometric mean ratios ( ratio of lobeglitazone and ketoconazole to lobeglitazone alone ) were investigated .
METHODS	Tolerability ( adverse events , vital signs , ECG , and laboratory tests ) was also assessed .
RESULTS	A total of 24 Korean men ( mean age , 26 years ; age range , 20-32 years ; mean weight , 68 kg ; weight range , 59-81 kg ) completed the study and were evaluable for lobeglitazone PK properties and tolerability .
RESULTS	The mean ( SD ) Cmax values of lobeglitazone with and without ketoconazole were 49 ( 7 ) ng/mL and 48 ( 6 ) ng/mL at 1.5 and 1.0 hours after dosing , respectively .
RESULTS	The mean ( SD ) AUC values were 532 ( 117 ) ngh/mL and 405 ( 110 ) ngh/mL , respectively .
RESULTS	Although the Cmax was not significantly affected , the geometric mean ratio for AUC was increased by a point estimate of 1.33 ( 90 % CI , 1.23-1 .44 ) .
RESULTS	A single oral administration of lobeglitazone 0.5 mg with or without ketoconazole pretreatment did not produce any clinically significant adverse effects on vital signs , 12-lead ECG profiles , or laboratory tests .
CONCLUSIONS	The administration of lobeglitazone , 0.5 mg alone or in combination with multiple doses of ketoconazole , was generally well tolerated .
CONCLUSIONS	The systemic exposure of lobeglitazone was increased to a modest extent by pretreatment with 9 twice-daily doses of ketoconazole .
CONCLUSIONS	Clinicaltrials.gov identifier : NCT01330563 .

###24487961
OBJECTIVE	Survivin is a member of the inhibitor-of-apoptosis family .
OBJECTIVE	Essential for tumor cell survival and overexpressed in most cancers , survivin is a promising target for anti-cancer immunotherapy .
OBJECTIVE	Immunogenicity has been demonstrated in multiple cancers .
OBJECTIVE	Nonetheless , few clinical trials have demonstrated survivin-vaccine-induced immune responses .
METHODS	This phase I trial was conducted to test whether vaccine EMD640744 , a cocktail of five HLA class I-binding survivin peptides in Montanide ( ) ISA 51 VG , promotes anti-survivin T-cell responses in patients with solid cancers .
METHODS	The primary objective was to compare immunologic efficacy of EMD640744 at doses of 30 , 100 , and 300 g. Secondary objectives included safety , tolerability , and clinical efficacy .
RESULTS	In total , 49 patients who received 2 EMD640744 injections with available baseline - and 1 post-vaccination samples [ immunologic-diagnostic ( ID ) - intention-to-treat ] were analyzed by ELISpot - and peptide/MHC-multimer staining , revealing vaccine-activated peptide-specific T-cell responses in 31 patients ( 63 % ) .
RESULTS	This cohort included the per study protocol relevant ID population for the primary objective , i.e. , T-cell responses by ELISpot in 17 weeks following first vaccination , as well as subjects who discontinued the study before week 17 but showed responses to the treatment .
RESULTS	No dose-dependent effects were observed .
RESULTS	In the majority of patients ( 61 % ) , anti-survivin responses were detected only after vaccination , providing evidence for de novo induction .
RESULTS	Best overall tumor response was stable disease ( 28 % ) .
RESULTS	EMD640744 was well tolerated ; local injection-site reactions constituted the most frequent adverse event .
CONCLUSIONS	Vaccination with EMD640744 elicited T-cell responses against survivin peptides in the majority of patients , demonstrating the immunologic efficacy of EMD640744 .

###24368363
BACKGROUND	Physiotherapy is integral to modern trauma care .
BACKGROUND	Early physiotherapy and mobility have been shown to improve outcomes in patients with isolated injuries ; however , the optimal intensity of physiotherapy in the multitrauma patient population has not yet been examined .
BACKGROUND	The primary aim of this study was to determine whether an intensive physiotherapy program resulted in improved inpatient mobility .
METHODS	We conducted a single-center prospective randomized controlled study of 90 consecutive patients admitted to the Alfred Hospital ( a Level 1 trauma center ) in Australia between October 2011 and June 2012 who could participate in ward-based physiotherapy .
METHODS	Participants were allocated to either usual care ( daily physiotherapy treatment , approximately 30 minutes ) or intensive physiotherapy ( usual care plus two additional 30-minute treatments each day ) .
METHODS	The primary outcome measure was the modified Iowa Level of Assistance ( mILOA ) score , collected by a blinded assessor at Days 3 and 5 ( or earlier if discharged ) .
METHODS	Secondary measures included physical readiness for discharge , hospital and rehabilitation length of stay , a patient confidence and satisfaction scale , and quality of life at 6 months .
RESULTS	Groups were comparable at baseline .
RESULTS	Participants in the intensive physiotherapy group achieved significantly improved mILOA scores on Day 3 ( median , 7 points compared with 10 points ; p = 0.02 ) and Day 5 ( median , 7.5 points compared with 16 points ; p = 0.04 ) and were more satisfied with their care ( p = 0.01 ) .
RESULTS	There was no difference between groups in time to physical readiness , discharge destination , length of stay , or quality-of-life measures .
CONCLUSIONS	Intensive physiotherapy resulted in improved mobility in trauma inpatients .
CONCLUSIONS	Further studies are required to determine if specific groups benefit more from intensive physiotherapy and if this translates to long-term improvements in outcomes .
METHODS	Therapeutic study , level 1 .

###24899557
BACKGROUND	Uncertainty may limit communication and affect the ability of patients to adapt to their illness .
BACKGROUND	A high level of uncertainty in patients concurrent with sudden hearing loss has been related to poor comprehension of communications and poor illness understanding .
BACKGROUND	Currently , there is no any certain standard information sheet in the clinical setting .
OBJECTIVE	This study evaluates the effect of a one-to-one oral instruction strategy combined with an information sheet firstly on the stimuli frame and then on uncertainty in patients suffering from idiopathic sudden sensorineural hearing loss .
METHODS	An experimental design was employed and 60 patients were randomly assigned to either the experimental group ( n = 28 ) or the control group ( n = 32 ) .
METHODS	A structured questionnaire that included the stimuli frame of uncertainty and the Mishel uncertainty illness scale was used to collect data .
METHODS	All samples received regular care following admission to the hospital and received the pretest within 24 hours after admission .
METHODS	The experimental group received the one-to-one oral instruction strategy combined with an information sheet immediately after the pretest .
METHODS	All participants completed the posttest three days later .
RESULTS	The health education program increased perceived understanding of illness in patients with the sudden hearing loss , and reduced their illness uncertainty .
RESULTS	Perceived understanding of illness was negatively related to the level of illness uncertainty .
RESULTS	The stimuli frame of uncertainty acted as a mediator between the intervention and the uncertainty .
RESULTS	The intervention increased the level of cognition of the stimuli frame of uncertainty and then indirectly lowered the uncertainty level .
CONCLUSIONS	These findings support the effectiveness of the individual health education strategy with the information sheet in delivering to patients critical information about their condition and treatment .
CONCLUSIONS	Moreover , this intervention may effectively increase illness cognition and reduce uncertainty in patients with sudden hearing loss .
CONCLUSIONS	Clinical nurse staffs may use the findings of this study to improve their health education efficacy .

###24811226
OBJECTIVE	Preterm labor and delivery are of the most important complications of pregnancy and have a major role in neonatal mortality and morbidity .
OBJECTIVE	Management of preterm labor and prevention from preterm delivery in order to lower these risks have always been under serious concern .
OBJECTIVE	The purpose of this study was to compare the effect of nifedipine and nitroglycerin ( NG ) dermal patch for taking control of preterm labor .
METHODS	The study was performed as a randomized clinical trial on women who had been admitted in the hospital diagnosed with preterm labor .
METHODS	In one group , the NG dermal patch and in the other group , nifedipine was prescribed .
METHODS	Then the women of the two groups were followed up to delivery and were compared according to arrest of labor for 2h , 48h , 7 days , gestational age at the time of delivery and their adverse effects .
METHODS	The primary outcome was to postpone delivery for 48h in order to have enough time for prescribing corticosteroids
RESULTS	The women of the two groups did not have any significant difference according to age , body mass index , primary Bishop Score , gestational age at the time of tocolytic therapy , history of abortion , vaginal or cesarean delivery and preterm labor .
RESULTS	In more women in the NG group , delivery was postponed for 2h ( 59 ( 98.3 % ) vs 48 ( 80 % ) , P = 0.001 ) , for 48h ( 52 women ( 86.7 % ) vs 41 ( 68.3 % ) , P = 0.016 ) and also for 7 days ( 47 ( 78.3 % ) vs 37 ( 61.7 % ) , P = 0.046 ) , than the women in the nifedipine group .
RESULTS	Gestational age at the time of delivery was higher in the NG group ( 35.61.9 vs 34.32.05 weeks , P = 0.155 ) , however , it was not statistically significant .
RESULTS	Apgar score of minute 5 , ( P = 0.03 ) and neonatal weight ( P = 0.04 ) , were more and cesarean deliveries , neonatal intensive care unit ( NICU ) admission and duration of NICU stay were less in the NG group .
RESULTS	Adverse effects were similar , minimal and negligible in both groups .
CONCLUSIONS	The NG patch is a more effective method for preterm labor control than nifedipine with regard to minimal side effects .

###25217875
OBJECTIVE	To determine whether incubation in the integrated EmbryoScope time-lapse monitoring system ( TMS ) and selection supported by the use of a multivariable morphokinetic model improve reproductive outcomes in comparison with incubation in a standard incubator ( SI ) embryo culture and selection based exclusively on morphology .
METHODS	Prospective , randomized , double-blinded , controlled study .
METHODS	University-affiliated private invitro fertilization ( IVF ) clinic .
METHODS	Eight hundred forty-three infertile couples undergoing intracytoplasmic sperm injection ( ICSI ) .
METHODS	No patient intervention ; embryos cultured in SI with development evaluated only by morphology ( control group ) and embryos cultured in TMS with embryo selection was based on a multivariable model ( study group ) .
METHODS	Rates of embryo implantation , pregnancy , ongoing pregnancy ( OPR ) , and early pregnancy loss .
RESULTS	Analyzing per treated cycle , the ongoing pregnancy rate was statistically significantly increased 51.4 % ( 95 % CI , 46.7-56 .0 ) for the TMS group compared with 41.7 % ( 95 % CI , 36.9-46 .5 ) for the SI group .
RESULTS	For pregnancy rate , differences were not statistically significant at 61.6 % ( 95 % CI , 56.9-66 .0 ) versus 56.3 % ( 95 % CI , 51.4-61 .0 ) .
RESULTS	The results per transfer were similar : statistically significantdifferences in ongoing pregnancy rate of 54.5 % ( 95 % CI , 49.6-59 .2 ) versus 45.3 % ( 95 % CI , 40.3-50 .4 ) and not statisticallysignificantfor pregnancy rate at 65.2 % ( 95 % CI , 60.6-69 .8 ) versus 61.1 % ( 95 % CI , 56.2-66 .1 ) .
RESULTS	Early pregnancy loss wasstatistically significantly decreased for the TMS group with 16.6 % ( 95 % CI , 12.6-21 .4 ) versus 25.8 % ( 95 % CI , 20.6-31 .9 ) .
RESULTS	The implantation rate was statistically significantly increased at 44.9 % ( 95 % CI , 41.4-48 .4 ) versus 37.1 % ( 95 % CI , 33.6-40 .7 ) .
CONCLUSIONS	The strategy of culturing and selecting embryos in the integrated EmbryoScope time-lapse monitoring system improves reproductive outcomes .
BACKGROUND	NCT01549262 .

###24300630
BACKGROUND	Once the diagnosis of Helicobacter pylori is confirmed , treatment requires at least two antibiotics and an acid inhibitor for a minimum of seven days .
BACKGROUND	Unfortunately , treatment failures are being frequently reported .
BACKGROUND	Treatment regimens that include sequential administration of antibiotics with acid inhibitors have been developed to try and increase the rate of eradication .
OBJECTIVE	To determine the effectiveness of a novel 10-day sequential therapy compared with the standard 10-day triple therapy for treatment of H. pylori infection in children .
METHODS	A double-blinded , randomised , controlled trial was conducted .
METHODS	Children under the age of 16 years with recurrent abdominal pain associated with dyspepsia and diagnosed with H. pylori by histology were randomly allocated either to a 10-day sequential treatment regimen or to a 10-day conventional triple therapy .
METHODS	Analysis of the outcome of this study was based on clinical improvement and confirmed H. pylori eradication based on stool H. pylori antigen detection and/or repeat endoscopy .
RESULTS	Of the 71 patients included in the analysis , 45 ( 63.4 % ) were given the 10-day conventional treatment while 26 ( 36.6 % ) received the 10-day sequential treatment .
RESULTS	There was no difference in clinical improvement after treatment in the two therapies .
RESULTS	However , there was a significant difference in the eradication of H. pylori between the conventional v. sequential regimens ( 48.8 % v. 84.6 % , respectively ; p = 0.02 , odds ratio 0.19 ) .
CONCLUSIONS	The sequential treatment had a significantly higher H. pylori eradication rate than the conventional treatment .

###25321951
OBJECTIVE	Wavefront-guided ( WFG ) and wavefront-optimized ( WFO ) platforms for refractive surgery are designed for improved visual outcomes .
OBJECTIVE	It is unclear which treatment profile is superior for patients undergoing photorefractive keratectomy ( PRK ) .
OBJECTIVE	To compare the safety , efficacy , predictability , stability , and higher-order aberrations in eyes undergoing WFG and WFO PRK .
METHODS	A prospective , randomized , fellow-eye-controlled clinical trial was conducted at the Byers Eye Institute at Stanford with enrollment between April 2009 and March 2011 ; 1 year of follow-up was included .
METHODS	Of 90 patients screened , 71 patients ( 142 eyes ) with less than 12.00 diopters ( D ) of spherical myopia and less than 3.00 D of astigmatism were enrolled consecutively .
METHODS	One eye was randomized to undergo WFG PRK treatment ( Visx CustomVue Star S4 IR excimer laser system ; Abbott Medical Optics ) , and the fellow eye received WFO PRK treatment ( WaveLight Allegretto Wave Eye-Q 400 Hz excimer laser system ; Alcon Surgical ) .
METHODS	Data on the manifest refraction , uncorrected visual acuity , best-corrected visual acuity , 5 % and 25 % contrast best-corrected visual acuity , and higher-order aberrations were collected preoperatively and at the 1 - , 3 - , 6 - , and 12-month follow-up visits .
RESULTS	Eyes undergoing both treatments had improved best-corrected visual acuity ( WFG : mean , 0.05 [ 95 % CI , 0.03-0 .07 ] ; WFO : mean , 0.04 [ 95 % CI , 0.02-0 .06 ] ) and less sphere ( WFG : mean , -4.79 [ 95 % CI , -5.31 to -4.26 ] ; WFO : mean , -4.61 [ 95 % CI , -5.18 to -4.03 ] ) , cylinder ( WFG : mean , 0.66 [ 95 % CI , 0.49-0 .82 ] ; WFO : mean , 0.52 [ 95 % CI , 0.35-0 .69 ] ) , and spherical equivalents ( WFG : mean , -4.45 [ 95 % CI , -4.99 to -3.91 ] ; WFO : mean , -4.34 [ 95 % CI , -4.92 to -3.76 ] ) ( P < .001 ) but higher levels of spherical aberration ( WFG : mean , -0.11 [ 95 % CI , -0.15 to -0.06 ] ; WFO : mean , -0.11 [ 95 % CI , -0.14 to -0.07 ] ) ( P < .001 ) and higher-order root-mean-square aberrations ( WFO : mean , -0.07 [ 95 % CI , -0.12 to -0.02 ] ; WFO : mean , -0.12 [ 95 % CI , -0.17 to -0.70 ] ) ( P = .005 in WFG eyes and P < .001 in WFO eyes ) at 12 months compared with preoperative measurements .
RESULTS	A total of 93.0 % of the eyes in the WFG group and 94.4 % in the WFO had an uncorrected visual acuity of 20/20 or better at 12 months , with 56.3 % in the WFG group and 43.7 % in the WFO group gaining 1 or more lines of best-corrected visual acuity .
RESULTS	The stability of the refractive correction was excellent for both groups .
CONCLUSIONS	A difference in uncorrected visual acuity or contrast acuity between eyes undergoing WFG or WFO treatment at 3 months and beyond could not be identified .
CONCLUSIONS	This lack of difference suggests that both systems can be used to provide excellent improvement in vision for persons with myopia .
BACKGROUND	clinicaltrials.gov Identifier : NCT01135719 .

###24905929
OBJECTIVE	This study investigated the short-term efficacy of low-level laser therapy ( LLLT ) in patients with mild to moderate carpal tunnel syndrome ( CTS ) , lasting for < 1 year .
METHODS	Seventy-nine patients with CTS were included in this double-blind , placebo-controlled study , and randomly divided in two treatment groups : Experimental group ( EG ) , active laser group ( 40 patients ) ; and control group ( CG ) , placebo ( sham ) laser group ( 39 patients ) .
METHODS	A GaAlAs diode laser [ 780 nm , 30 mW continuous wave ( CW ) , 0.785 cm ( 2 ) , 38.2 mW/cm ( 2 ) ] was applied in contact with four points perpendicularly to the skin over the carpal tunnel area for 90 sec per point ( 2.7 J , 3.4 J/cm ( 2 ) / point ) .
METHODS	Both groups were treated five times per week , once a day over 2 weeks , followed by 10 treatments every other day for 3 weeks , that is , for a total of 20 treatments .
METHODS	Clinical assessment , including visual analogue scale ( VAS ) pain rating , Tinel 's sign , and median nerve conduction studies ( NCSs ) were evaluated before , and 3 weeks after , the last LLLT treatment .
RESULTS	Significant reduction in pain , reduction in the percentage of patients with a positive Tinel 's sign , and shortening of sensory and motor latency time in the NCS examination was observed in the experimental LLLT group ( but not in the control group ) .
CONCLUSIONS	This study has observed and documented the statistically significant short-term effects of LLLT on CTS patients in comparison with a placebo group .
CONCLUSIONS	The results support this conclusion , especially if the LLLT is applied in the earlier stages of CTS , and with mild to moderate cases .

###25864240
OBJECTIVE	To compare dentin tubule occlusion by dentifrices containing either nanohydroxyapatite ( 10 % nHAP and 15 % nHAP ) , sodium monofluorophosphate ( Na-MFP ) or NovaMin ( NovaMin ) .
METHODS	All 80 participants wore four intraoral appliances bearing dentin blocks while using one of the four test dentifrices ( n = 20/dentifrice ) twice daily for 14 days .
METHODS	The four appliances were removed in pairs after 7 and 14 days .
METHODS	One treated block from each of the test periods ( 7 and 14 days ) and their untreated controls were examined with SEM to determine the level of tubule occlusion .
METHODS	The remaining two treated blocks and their controls were used to determine tubule permeability to dye solution .
METHODS	Effectiveness was compared statistically ( ANOVA/Tukey 's ) based on % area covered by deposited precipitate layer ( % DPL ) , % dye penetration inhibition ( % DPI ) and percentage of fully-open ( % FOT ) , partially-occluded ( % POT ) and completely-occluded ( % COT ) tubules in each block calculated relative to the number of tubules in their control blocks .
RESULTS	SEM showed increased % COT and % DPL overtime .
RESULTS	After 7 and 14 days , % COT , % POT , % DPL and % DPI were significantly lower with Na-MFP when compared to 10 % nHAP ( P < 0.01 ) , NovaMin ( P < 0.05 ) and 15 % nHAP ( P < 0.001 ) , the three of which were not significantly different from each other in those four variables .
RESULTS	A reverse trend was observed with % FOT ( P < 0.001 ) .
RESULTS	Within the same dentifrice , no difference in % COT , % POT , % FOT , % DPI and % DPL after 7 and 14 days , except with Na-MFP in which % DPL significantly ( P < 0.05 ) increased with usage .
RESULTS	In conclusion , nanohydroxyapatite-containing and NovaMin-containing toothpastes showed equal and more effectiveness in occluding dentin tubules than Na-MFP toothpaste .

###24509967
BACKGROUND	Imiquimod 3.75 % and 2.5 % creams were studied for the treatment of actinic keratosis ( AK ) of the full face or balding scalp , to determine comparable efficacy and tolerability to imiquimod 5 % cream .
METHODS	In two identical multicenter , randomized , double-blind , placebo controlled studies .
METHODS	Adult subjects with 5 to 20 visible lesions , or palpable AKs in an area that exceeded 25 cm on either the face or balding scalp were randomized to imiquimod 3.75 % , 2.5 % or vehicle cream ( 1:1:1 ) applied once daily for two 2-week treatment cycles , with a 2-week , no-treatment interval between cycles .
METHODS	Efficacy was assessed 8 weeks posttreatment ( End of Study Visit [ EOS ] ) .
METHODS	Primary efficacy was rate of complete clearance of AK lesions .
METHODS	Secondary efficacy endpoints were rate of partial clearance at EOS ( 75 % reduction in number of AK lesions compared to baseline ) and median percent decrease from baseline lesion count .
METHODS	Safety assessments included visual assessment of local skin reactions ( LSRs ) , number and duration of study treatment rest periods required due to intolerant LSRs , adverse events ( AEs ) and clinical laboratory tests .
RESULTS	Overall 479 patients were randomized to imiquimod 3.75 % , 2.5 % , or vehicle .
RESULTS	Complete clearance rates were 35.6 % , 30.6 % , and 6.3 % respectively ( both P < .001 versus vehicle ) .
RESULTS	The difference in complete clearance rates ( imiquimod minus vehicle ) was 29.3 % and 24.3 % , respectively .
RESULTS	Partial clearance rates were 59.4 % , 48.1 % , and 22.6 % respectively ( both P < .001 versus vehicle ) .
RESULTS	Median % reductions in AK lesions were 81.8 % , 71.8 % , and 25.0 % respectively ( P < .001 versus vehicle ) .
RESULTS	All primary and secondary efficacy endpoints were greater in Study 1 .
RESULTS	Photodamage in the treatment area was ` much improved ' with imiquimod 3.75 % .
RESULTS	Both active creams were well tolerated with few treatment-related discontinuations .
CONCLUSIONS	In two well-controlled Phase 3 studies , both imiquimod 3.75 % and 2.5 % creams were more effective than vehicle and well tolerated when administered daily as a 2-week on/off/on regimen to treat AK .
CONCLUSIONS	Reduction in AK lesions was comparable to that reported with imiquimod 5 % with fewer local AEs .

###24479702
BACKGROUND	Cannabis is the most consumed illegal substance in France .
BACKGROUND	General practitioners ( GPs ) are the health professionals who are most consulted by adolescents .
BACKGROUND	Brief intervention ( BI ) is a promising care initiative for the consumption of cannabis , and could be a tool for GPs in caring for adolescents who consume cannabis .
BACKGROUND	The aim of the CANABIC study is to measure the impact of a BI carried out by a GP on the consumption of cannabis by adolescents of 15 to 25years of age .
METHODS	A randomized clustered controlled trial , stratified over three areas ( Auvergne , Languedoc-Roussillon , and Rhne - Alpes ) , comparing an intervention group , which carries out the BI in consultation , and a control group , which ensures routine medical care .
METHODS	The main assessment criterion is the consumption of cannabis by amount of joints per month , at 12months .
METHODS	The amount necessary to highlight a significant difference between the two groups of 30 % of consumption at 12months is 250 patients ( 50 GPs , 5 patients per GP ; risk = 5 % ; power = 90 % ; intra-cluster correlation coefficient = 0.2 ; Hawthorne effect = 15 % ; lost to follow-up rates for GPs = 10 % and for patients = 20 % ) .
METHODS	This plan is replicated for the three areas , and therefore a total of 750 patients are expected.The secondary criteria for judgment are the associated consumption of tobacco and alcohol , the perception of the consequences of consumption , and the driving of a vehicle following consumption .
CONCLUSIONS	Research about BI for young cannabis users is underway .
CONCLUSIONS	The aim of the CANABIC study is to validate a BI suited to adolescents who consume cannabis , which may be performed in the general practice .
CONCLUSIONS	This would provide a tool for their treatment by a GP , which could be widely distributed during initial or further medical training .
BACKGROUND	CANABIC is a randomized clustered trial ( NCT01433692 , registered 2011 Sept 12 ) , PHRC funded : Clinical Research Hospital Program ( Governmental Fund , Health Ministry ) .
BACKGROUND	Date first patient randomized : March 2012 .

###24520664
OBJECTIVE	To evaluate the safety and effect of L-carnitine combined with tadalafil in the treatment of late-onset hypogonadism ( LOH ) with erectile dysfunction ( ED ) .
METHODS	We randomly divided 140 cases of LOH with ED aged 40 -70 years into a treatment and a control group to receive L-carnitine + tadalafil and testosterone undecanoate + tadalafil , respectively .
METHODS	After 8 weeks of treatment , we obtained the scores on IIEF-5 and Aging Male Symptoms ( AMS ) , observed changes in the levels of sex hormones , analyzed the results of the routine blood test and PSA level , and evaluated the safety of medication .
RESULTS	Finally , 110 cases were included , 60 in the treatment group and 50 in the control .
RESULTS	After 8 weeks of medication , the IIEF-5 and AMS scores were significantly improved as compared with the baseline both in the treatment group ( 17.7 + / - 3.5 vs 10.2 + / - 2.7 and 36.2 + / - 6.5 vs 48.8 + / - 5.8 ) and in the control group ( 16.7 + / - 2.6 vs 9.3 + / - 2.4 and 35.8 + / - 6.6 vs 50.7 + / - 5.0 ) ( both P < 0.05 ) , with no significant differences between the two groups ( P > 0.05 ) .
RESULTS	As for the safety of medication , there were no significant differences between the two groups before and after treatment ( P > 0.05 ) .
RESULTS	Two patients in the control group showed a PSA level > 4 microg/L , which was confirmed to be caused by prostatitis during follow-up .
CONCLUSIONS	L-carnitine combined with tadalafil is safe and effective for the treatment of LOH with ED .

###25156340
BACKGROUND	Coronary artery disease is highly prevalent in patients with stroke , but because revascularization does not improve major clinical outcomes in patients with stable coronary artery disease relative to intensive medical therapy , routine evaluation for this disease is not warranted in stroke patients .
BACKGROUND	However , it might be warranted in patients destined to undergo vigorous physical therapy .
BACKGROUND	The Locomotor Experience Applied Post-Stroke study , a randomized controlled trial of 408 participants that tested the relative efficacy of two rehabilitation techniques on functional walking level , provided the opportunity to address this question .
OBJECTIVE	The study aims to test the efficacy of screening for cardiovascular disease and an exercise tolerance test in assuring safety among patients undergoing vigorous rehabilitation for gait impairment .
METHODS	All participants were screened for serious cardiovascular and pulmonary conditions .
METHODS	At six-weeks poststroke , they also completed a cardiovascular screening inventory and underwent an exercise tolerance test involving bicycle ergometry .
METHODS	Participants received 36 , 90-min sessions of a prescribed physical therapy ( three per week ) , initiated at either two-months or six-months poststroke .
RESULTS	Twenty-nine participants were excluded on the basis of the cardiac screening questionnaire , and 15 failed the exercise tolerance test for cardiovascular reasons .
RESULTS	No participant experienced a cardiac event during a treatment session .
RESULTS	Two participants experienced myocardial infarctions , but continued in the trial .
RESULTS	In three additional participants , myocardial infarctions caused or contributed to death .
CONCLUSIONS	The combination of a negative cardiac screen and the absence of exercise tolerance test failure appeared to have a high negative predictive value for cardiac events during treatment , despite the likelihood of a high prevalence of coronary artery disease in our population .

###24480603
OBJECTIVE	To compare the effects of massage therapy ( moderate pressure stroking ) and exercise ( flexion and extension of limbs ) on preterm infants ' weight gain and to explore potential underlying mechanisms for those effects .
METHODS	Weight gain and parasympathetic nervous system activity were assessed in 30 preterm infants randomly assigned to a massage therapy group or to an exercise group .
METHODS	Infants received 10min of moderate pressure massage or passive flexion and extension of the limbs 3 times per day for 5days , and EKGs were collected during the first session to assess vagal activity .
RESULTS	Both massage and exercise led to increased weight gain .
RESULTS	However , while exercise was associated with increased calorie consumption , massage was related to increased vagal activity .
CONCLUSIONS	Taken together , these findings suggest that massage and exercise lead to increased preterm infant weight gain via different underlying mechanisms .

###25287325
BACKGROUND	Studies have shown that cannabis intake increases the risk of traffic accidents .
BACKGROUND	Controlled experiments support these findings and have shown a positive dose-effect relationship .
METHODS	In this retrospective cross-sectional study of data from a roadside survey , we investigated whether a police officer 's judgment regarding signs of impairment is related to the concentration of delta-9-tetrahydrocannabinol ( THC ) in the oral fluid ( OF ) .
METHODS	We investigated 2,632 cases from a representative sample of 3,302 Spanish drivers : 253 drivers positive for THC only , 32 positive for THC and ethanol , 201 with only ethanol detected in their breath , and 2,146 drivers who tested negative for ethanol in breath and drugs in OF .
METHODS	Recorded data comprised breath alcohol concentrations , THC concentrations in the OF , and the 31 observed signs of impairment .
METHODS	Subject groups were compared using the chi-square test , and logistic regression was used to examine the risk of being categorized as exhibiting signs of impairment .
RESULTS	A relationship was found between the OF THC concentration and some observed signs of impairment .
RESULTS	Eye signs were noticeable from a THC concentration > 3.0 ng/ml in OF , and > 25 ng/ml was related to behavior , facial expression , and speech signs .
RESULTS	Alcohol and THC contribute to impairment independently and , when taken simultaneously , the effects are comparable to the sum of the effects when consumed separately .
CONCLUSIONS	The observation of signs of impairment due to cannabis occurs in an OF concentration-related manner but , as a clinical test , OF has low sensitivity and specificity in a random roadside survey .

###25378208
BACKGROUND	Long-term effects of different weightbearing ( WB ) modalities after matrix-associated autologous chondrocyte implantation ( MACI ) on changes in knee articular cartilage and clinical outcomes are needed to establish more evidence-based recommendations for postoperative rehabilitation .
OBJECTIVE	There will be no differences between accelerated WB compared with delayed WB regarding knee articular cartilage or patient self-reported knee function or activity level 5 years after MACI .
OBJECTIVE	Furthermore , significant correlations between magnetic resonance imaging ( MRI ) - based outcomes and patient-reported outcome measures 5 years postoperatively will exist .
METHODS	Randomized controlled trial ; Level of evidence , 1 .
METHODS	After MACI , 31 patients ( 23 male , 8 female ) were randomly assigned to the accelerated WB group ( AWB group ) or to the delayed WB group ( DWB group ) .
METHODS	With the exception of time and increase to full WB , both groups underwent the same rehabilitation program .
METHODS	The AWB group was allowed full WB after 6 weeks and the DWB group after 10 weeks .
METHODS	Assessments were performed 3 months , 2 years , and 5 years postoperatively , but this long-term follow-up study only included changes from 2 to 5 years postoperatively .
METHODS	The magnetic resonance observation of cartilage repair tissue ( MOCART ) score ( primary outcome ) , the MRI-based variables of bone edema and effusion , the Knee Injury and Osteoarthritis Outcome Score ( KOOS ) , and the Tegner scale were included .
METHODS	In addition , the association between MRI-based outcomes and the KOOS at 5 years postoperatively was investigated .
RESULTS	There was a significant decrease in the MOCART score and a significant increase in bone edema 2 and 5 years postoperatively but no significant group differences .
RESULTS	The only significant correlation between the MRI-based variables and the KOOS was found for bone edema and the KOOS subscale of pain ( r = -0.435 , P < .05 ) at 5-year follow-up .
CONCLUSIONS	There were no significant differences in the MRI-based or clinical outcomes between the AWB group and DWB group 5 years after MACI .
CONCLUSIONS	While the clinical outcomes remained stable , a decline of the MRI-based findings was observed between 2 and 5 years postoperatively .
CONCLUSIONS	Furthermore , a significant association between bone edema and pain was found .
CONCLUSIONS	No occurrence of unintended effects was observed .

###24938502
OBJECTIVE	To determine the effects of rivastigmine patch associated with physical exercise versus rivastigmine patch alone in quality of life ( QOL ) , cognition , activities of daily living ( ADL ) and functional mobility in Alzheimer 's disease ( AD ) subjects .
METHODS	A randomized , controlled , single-blinded trial was conducted in 40 patients with mild to moderate stages of AD .
METHODS	All patients were daily treated with rivastigmine transdermal patch at a stable dose of 4.6 mg and randomized into two groups : physical exercises or control .
METHODS	The exercise program consisted of aerobic , flexibility , strength and balance movements , twice a week for 6 months .
METHODS	Main outcomes were Quality of Life in Alzheimer 's disease scale ( QOL ) , Activities of Daily Living Questionnaire ( ADL ) , Mini-Mental State Examination ( MMSE ) and `` Time Up and Go Test '' .
RESULTS	Thirty-four patients completed the study .
RESULTS	After 6 months , there was a significant improvement in QOL of patients randomized to physical exercise group ( P < 0.05 ) .
RESULTS	In both groups , there was an improvement on caregivers QOL ( P > 0.05 ) .
RESULTS	When considering cognitive functions , there was no difference between groups .
RESULTS	The ability to perform ADL worsened in the group enrolled to RTP alone .
RESULTS	There was an improvement in functional mobility in the group treated with RTP .
CONCLUSIONS	Our results suggest that the association between physical exercises and RTP improves QOL in patients with AD .
CONCLUSIONS	Cognition remained unchanged in both groups .
CONCLUSIONS	Regarding the effect of physical exercises in ADL , further trials are necessary to confirm these results .

###24998039
BACKGROUND	Immobilization of the spine of patients with trauma at risk of spinal damage is usually performed using a rigid long spineboard or vacuum mattress , both during prehospital and in-hospital care .
BACKGROUND	However , disadvantages of these immobilization devices in terms of discomfort and tissue-interface pressures have guided the development of soft-layered long spineboards .
BACKGROUND	We compared tissue-interface pressures between awake and anaesthetized ( unconscious ) patients during immobilization on a rigid spineboard and a soft-layered long spineboard .
METHODS	In this comparative study , 30 anaesthetized patients were randomized to immobilization on either the rigid spineboard or the soft-layered spineboard for the duration of their elective surgery .
METHODS	Tissue-interface pressures measured using an Xsensor pressure-mapping device were compared with those of 30 healthy volunteers who were immobilized sequentially on the rigid spineboard and the soft-layered spineboard .
METHODS	Redness of the sacrum was also recorded for the anaesthetized patients immediately after the surgery .
RESULTS	For both anaesthetized patients and awake volunteers , tissue-interface pressures were significantly lower on the soft-layered spineboard than on the rigid spineboard , both at start and after 15min .
RESULTS	On the soft-layered spineboard , tissue interface pressure and peak pressure index ( PPI ) for the sacrum were significantly lower for anaesthetized patients than for awake volunteers .
RESULTS	Peak pressures and PPI on the rigid spineboard were equal for both groups .
RESULTS	Tissue-interface pressures did not change significantly over time .
RESULTS	Redness of the sacrum was significantly more pronounced on the rigid spineboard than on the soft-layered spineboard .
CONCLUSIONS	This prospective randomized controlled trial shows that using a soft-layered spineboard compared to a rigid spineboard for spinal immobilization resulted in lower tissue-interface pressures in both awake volunteers and anaesthetized patients .
CONCLUSIONS	Moreover , tissue-interface pressures on the soft-layered spineboard were lower in anaesthetized patients than in awake volunteers .
CONCLUSIONS	These findings show the importance of using a soft-layered spineboard to reduce tissue-interface pressure , especially for patients who can not relieve pressure themselves by changing position .

###24467770
BACKGROUND	Few studies have designed and tested the use of continuous quality improvement approaches in community based substance use treatment settings .
BACKGROUND	Little is known about the feasibility , costs , efficacy , and sustainment of such approaches in these settings .
METHODS	A group-randomized trial using a modified stepped wedge design is being used .
METHODS	In the first phase of the study , eight programs , stratified by modality ( residential , outpatient ) are being randomly assigned to the intervention or control condition .
METHODS	In the second phase , the initially assigned control programs are receiving the intervention to gain additional information about feasibility while sustainment is being studied among the programs initially assigned to the intervention .
CONCLUSIONS	By using this design in a pilot study , we help inform the field about the feasibility , costs , efficacy and sustainment of the intervention .
CONCLUSIONS	Determining information at the pilot stage about costs and sustainment provides value for designing future studies and implementation strategies with the goal to reduce the time between intervention development and translation to real world practice settings .

###25927562
BACKGROUND	One of the main priorities of Dutch organisations providing shelter services is to develop evidence-based interventions in the care for abused women and homeless people .
BACKGROUND	To date , most of these organisations have not used specific intervention models and the interventions which have been implemented rarely have an empirical and theoretical foundation .
BACKGROUND	The present studies aim to examine the effectiveness of critical time intervention ( CTI ) for abused women and homeless people .
METHODS	In two multi-centre randomised controlled trials we investigate whether CTI , a time-limited ( nine month ) outreach intervention , is more effective than care-as-usual for abused women and homeless people making the transition from shelter facilities to supported or independent housing .
METHODS	Participants were recruited in 19 women 's shelter facilities and 22 homeless shelter facilities across The Netherlands and randomly allocated to the intervention group ( CTI ) or the control group ( care-as-usual ) .
METHODS	They were interviewed four times in nine months : once before leaving the shelter , and then at three , six and nine months after leaving the shelter .
METHODS	Quality of life ( primary outcome for abused women ) and recurrent loss of housing ( primary outcome for homeless people ) as well as secondary outcomes ( e.g. care needs , self-esteem , loneliness , social support , substance use , psychological distress and service use ) were assessed during the interviews .
METHODS	In addition , the model integrity of CTI was investigated during the data collection period .
CONCLUSIONS	Based on international research CTI is expected to be an appropriate intervention for clients making the transition from institutional to community living .
CONCLUSIONS	If CTI proves to be effective for abused women and homeless people , shelter services could include this case management model in their professional standards and improve the ( quality of ) services for clients .
BACKGROUND	NTR3463 and NTR3425 .

###25060189
BACKGROUND	Eye irritation is a constant hazard for migrant and seasonal farmworkers , but there are few studies of the problem or how to address it .
BACKGROUND	Researchers evaluated the effect of a community-based participatory eye health intervention on farmworker eye symptoms in the Hudson Valley , NY .
METHODS	A randomized pre-post intervention with 2 , 4-week follow-up periods was implemented with a sample of 97 farmworkers .
METHODS	Five eye symptoms were measured , along with utilization of protective eyewear and eye drops .
RESULTS	Leading baseline eye symptoms were redness ( 49 % ) , blurred vision ( 43 % ) , itching ( 43 % ) , and eye pain ( 29 % ) .
RESULTS	Significant reductions in eye pain ( P = 0.009 ) , and non-significant reductions in redness were observed for the intervention group while controls experienced increases in both .
CONCLUSIONS	The intervention was effective in significantly reducing eye pain , and to a lesser extent , redness .
CONCLUSIONS	Future eyewear promotion programs should offer a range of eye wear , tailor offerings to local climate and tasks , evaluate eyewear durability , and include eye drops .

###24595578
BACKGROUND	Treatments for papulopustular rosacea ( PPR ) are limited .
OBJECTIVE	To demonstrate the efficacy and safety of once-daily ivermectin 1 % cream in subjects with moderate to severe PPR .
METHODS	Two identically designed , randomized , double-blind , controlled studies of ivermectin 1 % cream ( IVM 1 % ) or vehicle once daily for 12 weeks were conducted in subjects with moderate to severe PPR .
METHODS	Efficacy assessments were Investigator 's Global Assessment ( IGA ) of disease severity and inflammatory lesion counts .
METHODS	Safety assessments included incidence of adverse events ( AEs ) and local tolerance parameters .
METHODS	Subjects evaluated their rosacea and completed satisfaction and quality of life ( QoL ) questionnaires .
RESULTS	In both studies , a greater proportion of subjects in the IVM 1 % group achieved treatment success ( IGA `` clear '' or `` almost clear '' ) : 38.4 % and 40.1 % vs 11.6 % and 18.8 % for vehicle ( both P < .001 ) , respectively .
RESULTS	Ivermectin was superior to vehicle in terms of reduction from baseline in inflammatory lesion counts ( 76.0 % and 75.0 % vs 50.0 % for both vehicle groups , respectively ) .
RESULTS	For all endpoints , starting at week 4 and continuing through week 12 , IVM 1 % was statistically significantly superior ( P < .001 ) .
RESULTS	Fewer subjects treated by IVM 1 % reported dermatologic AEs , and a higher proportion of subjects were observed to have no skin dryness or itching compared to vehicle .
RESULTS	Significantly more subjects receiving IVM 1 % reported having an `` excellent '' or `` good '' improvement , along with an improved QoL .
CONCLUSIONS	Ivermectin 1 % cream was effective and safe in treating inflammatory lesions of papulopustular rosacea .

###25878175
OBJECTIVE	To determine whether a novel endpoint of time to prerandomization monthly seizure count could be used to differentiate efficacious and nonefficacious therapies in clinical trials of new add-on antiepileptic drugs ( AEDs ) .
METHODS	This analysis used data from 3 randomized , double-blind , placebo-controlled phase III trials of perampanel as an add-on therapy in patients with epilepsy who were experiencing refractory partial seizures : studies 304 ( ClinicalTrials.gov identifier NCT00699972 ) , 305 ( NCT00699582 ) , and 306 ( NCT00700310 ) .
METHODS	Time to prerandomization monthly seizure count was evaluated post hoc for each trial , and findings were compared with the original primary outcomes ( median percent change in seizure frequency and 50 % responder rate ) .
METHODS	Outcomes were assessed for all partial-onset seizures , secondarily generalized ( SG ) tonic-clonic seizures only , and complex partial plus SG ( CP + SG ) seizures .
RESULTS	Perampanel 4-12 mg significantly prolonged median time to prerandomization monthly seizure count , generally by more than 1 week , compared with placebo , across all 3 studies , consistent with the original primary outcomes .
RESULTS	Analysis of SG seizures only , and CP + SG seizures , also indicated a significantly prolonged median time to prerandomization monthly seizure count with perampanel 8 mg and 12 mg compared with placebo .
CONCLUSIONS	Time to prerandomization monthly seizure count is a promising novel alternative to the standard endpoints of median percent change in seizure frequency and 50 % responder rates used in trials of add-on AEDs .
CONCLUSIONS	Use of this endpoint could reduce exposure to placebo or ineffective treatments , thereby facilitating trial recruitment and improving safety .

###24981605
BACKGROUND	Patients are at risk of drug-related problems ( DRPs ) at transition points during hospitalization .
BACKGROUND	The community pharmacist ( CP ) is often the first healthcare professional patients visit after discharge .
BACKGROUND	CPs lack sufficient information about the patient and so they may be unable to identify problems in medications , which may lead to dispensing the wrong drugs or dosage , and/or giving wrong information .
BACKGROUND	We aim to assess the impact of a complex intervention comprising of medication reconciliation performed at discharge by a hospital pharmacist ( HP ) with communication between the HP and CP on DRPs during the seven days following discharge .
METHODS	The study is a cluster randomized crossover trial involving 46 care units ( each unit corresponding to a cluster ) in 22 French hospitals during two consecutive 14-day periods , randomly assigned as ` experimental ' or ` control ' ( usual care ) periods .
METHODS	We will recruit patients older than 18 years of age and visiting the same CP for at least three months .
METHODS	We will exclude patients with a hospital length of stay of more than 21 days , who do not return home or those in palliative care .
METHODS	During the experimental period , the HP will perform a medications reconciliation that will be communicated to the patient .
METHODS	The HP will inform the patient 's CP about the patient 's drug therapy ( modification in home medication , acute drugs prescribed , nonprescription treatments , and/or lab results ) .
METHODS	The primary outcome will be a composite outcome of any kind of drug misuse during the seven days following discharge assessed at day seven ( 2 ) post-discharge by a pharmacist in charge of the study who will contact both patients and CPs by phone .
METHODS	The secondary outcome will be unplanned hospitalizations assessed by phone contact at day 35 ( 5 ) after discharge .
METHODS	We plan to recruit 1,176 patients .
CONCLUSIONS	This study will assess the impact of a reconciliation of medications performed at patient discharge followed by communication between the HP and the patient 's CP .
CONCLUSIONS	It will allow for identifying the type of patients in France for which the intervention is most relevant .
BACKGROUND	This study was registered with ClinicalTrials.gov ( number : NCT02006797 ) on 5 December 2013 .

###25301344
BACKGROUND	The current efforts of intensivists focused on individual antibiotic treatment in patients suffering from sepsis has inspired us to conduct an open prospective clinical study to assess the relationship between body fluid retention ( > 10 L/24 hours ) and the efficiency of hydrophilic time-dependent antibiotics used in critically ill patients .
BACKGROUND	Polytrauma and abdominal catastrophes are the most frequent causes of systemic inflammatory response syndrome ( SIRS ) .
BACKGROUND	Consequent body liquid retention is taken for a pathophysiological covariate modifying the pharmacokinetics ( PK ) and pharmacodynamics ( PD ) of hydrophilic time-dependent antibiotics ( betalactams and carbapenems ) .
BACKGROUND	Not only body fluid retention but also changes in renal clearance are thought to be responsible for failure in PK/PD target attainment necessary for effective antimicrobial activity .
BACKGROUND	To describe the importance of the pathophysiological covariates for the individual kinetic variables of a representative antibiotic ( piperacillin ) is the primary goal of this kinetic observational study .
METHODS	Three patients with polytrauma and SIRS admitted at the ICU of the Surgical Department , Teaching Hospital Hradec Krlov , whose condition was characterized by cumulative body fluid retention ( > 10 L ) , were eligible for enrolment .
METHODS	As per standard hospital protocol , the patients were administered with 4 g of piperacillin in combination with tazobactam 0.5 g intravenously by 1-hour ( h ) infusion every 8 h.
METHODS	A series of blood samples were taken 1 , 2.5 , and 5 h after the termination of the infusion .
METHODS	Urine was collected over each dosing interval and for 24 h. Piperacillin was detected using a previously validated HPLC method .
METHODS	Individual pharmacokinetic variables were estimated using non-compartmental pharmacokinetic analysis .
METHODS	Cumulative body fluid retention was calculated as the difference between fluid intake and output .
METHODS	Creatinine clearance ( Cl ) was used for renal function evaluation .
METHODS	PK/PD target attainment was analysed according to Carlier ( 2013 ) .
RESULTS	In three patients with polytrauma and SIRS , great interindividual and intraindividual differences in extravascular volume expansion , i.e. cumulative body fluid retention 2030 L and changes in renal function , were recorded .
RESULTS	In 2/3 patients these pathophysiological changes as well as the clinical interventions administered resulted in augmented piperacillin clearance and an increase in distribution volume ( Vd ) ( > 20 L ) with a maximum at Day 28 after initiation of therapy .
RESULTS	In such patients treated with a standard dose of piperacillin , only minimum PK/PD target attainment ( 50 % Ft > MIC ) was obtained .
RESULTS	In contrast , a patient suffering from renal dysfunction attained both minimum ( 50 % ft > MIC ) and maximum PK/PD target ( 100 % ft > MIC ) .
CONCLUSIONS	In three critically ill patients with polytrauma and SIRS , pathophysiological changes ( covariates ) had a profound effect on the key determinants of the pharmacokinetics ( Cl and Vd ) , resulting in significant intraindividual variability in pharmacodynamic / pharmacokinetic target attainment necessary for therapeutic time-dependent antibacterial activity of piperacillin .
CONCLUSIONS	Consequently , patients with augmented clearance of piperacillin may be at risk for treatment failure , and/or bacterial resistance without dose up-titration .
CONCLUSIONS	A subsequent clinical study will be conducted to describe personalised kinetically guided antibiotic therapy .

###24535643
OBJECTIVE	Intracranial atherosclerosis represents a relatively unexplored , but potentially important , cause of stroke in a white population .
OBJECTIVE	To investigate the relationship between intracranial carotid artery calcification ( ICAC ) as a marker of intracranial atherosclerosis and the risk of stroke in whites .
METHODS	A population-based cohort study in the general community with 6 years of follow-up was conducted ( the Rotterdam Study ) .
METHODS	Between 2003 and 2006 , a random sample of 2323 stroke-free persons ( mean age , 69.5 years ) underwent computed tomography scanning to quantify ICAC volume .
METHODS	All participants were continuously monitored for the occurrence of stroke until January 1 , 2012 .
METHODS	Atherosclerotic calcification in the intracranial internal carotid arteries .
METHODS	Incident stroke .
RESULTS	During 14,055 person-years of follow-up , 91 participants had a stroke , of which 74 were ischemic .
RESULTS	Larger ICAC volume was related to a higher risk of stroke , independent of cardiovascular risk factors , ultrasound carotid plaque score , and calcification in other vessels ( fully adjusted hazard ratio per an increase of 1 SD in ICAC volume , 1.43 [ 95 % CI , 1.04-1 .96 ] ) .
RESULTS	Intracranial carotid artery calcification contributed to 75 % of all strokes ; for aortic arch and extracranial carotid artery calcification this incidence was only 45 % and 25 % , respectively .
CONCLUSIONS	Our findings establish intracranial atherosclerosis as a major risk factor for stroke in the general white population and suggest that its contribution to the proportion of all strokes may be greater than that of large-artery atherosclerosis in more proximally located vessel beds .

###24693675
BACKGROUND	Transient esophageal ulceration is a common finding after sclerotherapy of varices .
BACKGROUND	These ulcers sometimes cause pain , ulcer bleeding , and stricture formation .
BACKGROUND	Gastroesophageal reflux ( GER ) after Endoscopic injection sclerotherapy ( EIS ) is a known cause of worsening ulcer formation .
BACKGROUND	Therefore , an efficient drug for GER is desirable to improve the quality of life of patients with esophageal varices .
METHODS	We randomized 18 Japanese cirrhotic patients who had risky esophageal varices .
METHODS	The patients were randomly allocated into two groups , and during EIS sessions , one group was administered proton pump inhibitor ( PPI ) ( Rabeprazole 20 mg a person once a day ) , while the other received histamine H2 receptor antagonist ( H2-blocker ) ( famotidine 20 mg a person , twice a day ) .
METHODS	Gastroesophageal reflux was monitored by a 24-h pH-monitoring catheter introduced into the distal esophagus .
METHODS	Ulcer formation was evaluated using an endoscopic examination .
METHODS	The subjective and objective symptoms were also compared between the two groups .
RESULTS	All patients in the H2-blocker group showed an increased percentage of time with pH < 4.0 after EIS sessions , but no patients in the PPI group showed an increased such symptoms .
RESULTS	The H2-blocker group also experienced a significantly higher number of days of heartburn and dysphasia than did the PPI group ( p = 0.017 , p = 0.042 ) .
RESULTS	The rate of ulcer improvement was found to be faster in Rabeprazole group than in H2 blocker group ( p = 0.008 ) .
CONCLUSIONS	These results suggest that Rabeprazole treatment prevents EIS-associated gastroesophageal reflux and promotes ulcer healing .
CONCLUSIONS	Rabeprazole also improve the subjective symptoms following EIS .

###25244402
OBJECTIVE	To evaluate the efficacy and safety of gatifloxacin 0.5 % ophthalmic solution administered twice daily for treatment of acute bacterial conjunctivitis .
METHODS	Two identically designed , double-masked , multicenter studies in the United States and India enrolled patients 1 year or older with acute bacterial conjunctivitis .
METHODS	Patients were randomized to gatifloxacin 0.5 % or vehicle treatment for 5 days .
METHODS	Clinical success in clearing conjunctival hyperemia and discharge at day 6 ( primary endpoint ) and day 4 and microbiological cure were determined .
METHODS	Isolates from positive conjunctival samples were tested for sensitivity and susceptibility .
METHODS	Safety measures included adverse events ( AEs ) .
METHODS	Data from these 2 studies were pooled for these analyses .
RESULTS	Of the 1437 randomized patients , 658 constituted the modified intent-to-treat population .
RESULTS	Patient characteristics were similar between the pooled treatment groups .
RESULTS	Clinical success occurred for 58.0 % of gatifloxacin 0.5 % - treated versus 45.5 % vehicle-treated patients at day 6 ( P = 0.001 ) and for 23.7 % versus 15.4 % in the respective groups at day 4 ( P = 0.007 ) .
RESULTS	Microbiological cure was higher with gatifloxacin 0.5 % than vehicle at days 4 and 6 ( P < 0.001 for both time points ) .
RESULTS	The combined minimum inhibitory concentration required to inhibit 90 % of isolates for gatifloxacin 0.5 % was 2.0 g/mL for gram-positive and gram-negative organisms .
RESULTS	AEs were reported by 11.6 % and 13.3 % of patients in the gatifloxacin 0.5 % and vehicle safety populations , respectively .
RESULTS	One patient in each treatment group experienced a serious AE ; neither was treatment related .
CONCLUSIONS	The 0.5 % concentration of gatifloxacin ophthalmic solution was safe and effective for treatment of acute bacterial conjunctivitis with twice-daily administration for 5 days .

###25868203
BACKGROUND	Reduced postoperative pain is considered one of the benefits of laparoscopic inguinal hernia repair ( LHR ) .
BACKGROUND	We investigated the need for intravenous flurbiprofen axetil ( FA ) before emergence from anesthesia in patients who had undergone LHR .
METHODS	Forty adult patients who were prepared for LHR were randomly divided into the FA group ( FA 1 mg x kg ( -1 ) administered at the end of surgery , n = 20 ) and the control group ( no FA administration , n = 20 ) .
METHODS	Postoperative pain was evaluated by the Prince Henry Pain Score ( PHPS ) as well as by the frequency of on-demand use of nonsteroidal antiinflammatory drugs ( NSAIDs ) .
RESULTS	The PHPS on arrival at the ward was significantly lower in the FA group than the control group .
RESULTS	Additionally , none of the patients of the FA group required NSAIDs in the first two hours of postoperative period , compared with 6 patients ( 30 % ) of the control group .
RESULTS	However , at 4 hours postoperatively , none of the patients of both groups suffered pain at rest and the PHPS was similar in the two groups .
CONCLUSIONS	Although postoperative pain after LHR is mild and disappears rapidly , FA administration before emergence from anesthesia is necessary for management of pain during the immediate postoperative period .

###24906174
OBJECTIVE	The aim of this study was to evaluate the efficacy and safety of combinations of lercanidipine ( L ) and enalapril ( E ) at different doses on office and home blood pressure ( BP ) in patients with Stage 2 hypertension .
METHODS	This was a randomized , double-blind , placebo-controlled , factorial study conducted in 100 centres from seven countries .
METHODS	Patients with office DBP 100-109mmHg and home DBP at least 85mmHg at the end of a 2-week placebo run-in period were randomized to a 10-week treatment with placebo , L ( 10 or 20mg ) , E ( 10 or 20mg ) or the four L-E combinations .
METHODS	The efficacy parameters were office DBP at trough ( primary ) , SBP at trough and home SBP and DBP .
METHODS	Office BP was measured at each visit in both the sitting and the standing position , while home BP was measured twice in the morning and twice in the evening for at least 3 days before treatment and at study end .
METHODS	Safety parameters included adverse events , laboratory tests and 12-lead ECG .
RESULTS	A total of 1039 patients were randomized ( 48 % men , mean age 54 years , mean BMI 30kg/m , 40 % obese patients ) .
RESULTS	Baseline BP was similar in all groups and lower for home than for office values ( 149/95 and 159/103mmHg , respectively ) .
RESULTS	A marked placebo effect was observed on office but not on home BP .
RESULTS	Combination therapy was superior to placebo at all doses for both office and home BP .
RESULTS	The greatest effect was observed in the L20/E20 group , in which the SBP/DBP fall amounted to -19.2 / -15.2 and -13.2 / -7.5 mmHg for sitting office and home BP , respectively .
RESULTS	Similar reductions were observed on standing office BP .
RESULTS	The L20/E20 combination was associated with less cough , palpitations and leg oedema than monotherapies , with no increased rate of dizziness or hypotension .
CONCLUSIONS	In Stage 2 hypertension , a fixed-dose combination of L and E ensures a control of both office and out-of-office BP , with a favourable tolerability profile .

###24680796
BACKGROUND	Successful preventive therapy for ischemic priapism , a disorder of penile erection with major physical and psychologic consequences , is limited .
BACKGROUND	We conducted a randomized , double-blind , placebo-controlled clinical trial to assess the efficacy and safety of sildenafil by a systematic dosing protocol to prevent recurrent ischemic priapism associated with sickle cell disease .
METHODS	Thirteen patients with sickle cell disease reporting priapism recurrences at least twice weekly were randomized to receive sildenafil 50 mg or placebo daily , unassociated with sleep or sexual activity , for 8 weeks , followed by open-label use of this sildenafil regimen for an additional 8 weeks .
RESULTS	Priapism frequency reduction by 50 % did not differ between sildenafil and placebo groups by intention-to-treat or per protocol analyses ( P = 1.0 ) .
RESULTS	However , during open-label assessment , 5 of 8 patients ( 62.5 % ) by intention-to-treat analysis and 2 of 3 patients ( 66.7 % ) by per protocol analysis met this primary efficacy outcome .
RESULTS	No significant differences were found between study groups in rates of adverse effects , although major priapism episodes were decreased 4-fold in patients monitored `` on-treatment . ''
CONCLUSIONS	Sildenafil use by systematic dosing may offer a strategy to prevent recurrent ischemic priapism in patients with sickle cell disease .

###24255998
BACKGROUND	Goal of the presented study is to evaluate whether alcohol-dependent patients given additional individual psychotherapy after a heavy relapse during pharmacotherapy remain abstinent for longer than those who continue with pharmacotherapy alone .
METHODS	In a randomized , multicenter study , 109 alcohol-dependent patients who had suffered a heavy relapse either while receiving anticraving medication or placebo were randomized into 2 groups .
METHODS	One group received medication , medical management , and additional individual , disorder-specific , cognitive-behavioral psychotherapy , while the control group received medication and medical management only .
METHODS	Main outcome was defined as days until first heavy relapse .
RESULTS	Fifty-four patients were randomized to the psychotherapy group , 55 to the control group .
RESULTS	Intention-to-treat and completer analyses found no differences between groups , whereas as-treated analyses ( patients who actually received psychotherapy compared with those who did not ) found a significant effect of psychotherapy .
CONCLUSIONS	Our data indicate that patients that are willing to attend psychotherapy benefit from receiving psychotherapy in addition to pharmacotherapy .
CONCLUSIONS	We suggest that it may be beneficial to consider patients ' preferences concerning psychotherapy at an earlier stage during treatment .

###25450583
OBJECTIVE	Nonalcoholic fatty liver disease ( NAFLD ) is the most common cause of chronic liver injury .
OBJECTIVE	Chronic exposure to oxidative stress leads to depletion of liver antioxidants and abnormal cytokine production ; antioxidant therapy is one of the main therapeutic lines in NAFLD .
OBJECTIVE	In the current study we aimed to investigate the effect of coenzyme Q10 ( coQ10 ) therapy on several adipocytokines and insulin resistance in patients with NAFLD .
METHODS	In the current randomized double-blind placebo controlled trial 44 NAFLD patients were enrolled .
METHODS	After randomization into two groups , 22 patients received 100 mg/day coQ10 capsules and 22 patients received placebo daily for 4 weeks .
METHODS	BMI and WHR were calculated for patients at the beginning and end of the study and blood samples were obtained from the patients to measure serum concentrations of aspartate aminotransferase ( AST ) , alanine aminotransferase ( ALT ) , fasting serum glucose ( FSG ) , insulin resistance ( IR ) , vaspin , chemerin , pentraxin 3 ( PTX3 ) and markers of oxidative stress including total antioxidant capacity ( TAC ) and malondialdehyde ( MDA ) .
RESULTS	After 4 weeks of coQ10 supplementation , waist circumference ( WC ) and serum AST and TAC concentrations significantly decreased in intervention group ( p < 0.05 ) but no significant changes occurred in placebo-treated group .
RESULTS	In stepwise multivariate linear regression model , change in serum FSG was a significant predictor of changes in serum vaspin , chemerin and pentraxin 3 ( p < 0.001 ) .
CONCLUSIONS	The present study showed a potential for coQ10 therapy in improving several anthropometric and biochemical variables in NAFLD .
CONCLUSIONS	Longer studies with higher doses of coQ10 are required to further evaluate this potential benefit .

###24612754
BACKGROUND	Observational evidence suggests that community-based services for people with schizophrenia can be successfully provided by community health workers , when supervised by specialists , in low-income and middle-income countries .
BACKGROUND	We did the COmmunity care for People with Schizophrenia in India ( COPSI ) trial to compare the effectiveness of a collaborative community-based care intervention with standard facility-based care .
METHODS	We did a multicentre , parallel-group , randomised controlled trial at three sites in India between Jan 1 , 2009 and Dec 31 , 2010 .
METHODS	Patients aged 16-60 years with a primary diagnosis of schizophrenia according to the tenth edition of the International Classification of Diseases , Diagnostic Criteria for Research ( ICD-10-DCR ) were randomly assigned ( 2:1 ) , via a computer-generated randomisation list with block sizes of three , six , or nine , to receive either collaborative community-based care plus facility-based care or facility-based care alone .
METHODS	Randomisation was stratified by study site .
METHODS	Outcome assessors were masked to group allocation .
METHODS	The primary outcome was a change in symptoms and disabilities over 12 months , as measured by the positive and negative syndrome scale ( PANSS ) and the Indian disability evaluation and assessment scale ( IDEAS ) .
METHODS	Analysis was by modified intention to treat .
METHODS	This study is registered as an International Standard Randomised Controlled Trial , number ISRCTN 56877013 .
RESULTS	187 participants were randomised to the collaborative community-based care plus facility-based care group and 95 were randomised to the facility-based care alone group ; 253 ( 90 % ) participants completed follow-up to month 12 .
RESULTS	At 12 months , total PANSS and IDEAS scores were lower in patients in the intervention group than in those in the control group ( PANSS adjusted mean difference -3.75 , 95 % CI -7.92 to 0.42 ; p = 0.08 ; IDEAS -0.95 , -1.68 to -0.23 ; p = 0.01 ) .
RESULTS	However , no difference was shown in the proportion of participants who had a reduction of more than 20 % in overall symptoms ( PANSS 85 [ 51 % ] in the intervention group vs 44 [ 51 % ] in the control group ; p = 0.89 ; IDEAS 75 [ 48 % ] vs 28 [ 35 % ] ) .
RESULTS	We noted a significant reduction in symptom and disability outcomes at the rural Tamil Nadu site ( -9.29 , -15.41 to -3.17 ; p = 0.003 ) .
RESULTS	Two patients ( one in each group ) died by suicide during the study , and two patients died because of complications of a road traffic accident and pre-existing cardiac disease .
RESULTS	18 ( 73 % ) patients ( 17 in the intervention group ) were admitted to hospital during the course of the trial , of whom seven were admitted because of physical health problems , such as acute gastritis and vomiting , road accident , high fever , or cardiovascular disease .
CONCLUSIONS	The collaborative community-based care plus facility-based care intervention is modestly more effective than facility-based care , especially for reducing disability and symptoms of psychosis .
CONCLUSIONS	Our results show that the study intervention is best implemented as an initial service in settings where services are scarce , for example in rural areas .
BACKGROUND	Wellcome Trust .

###26079801
BACKGROUND	Complications with IV patient-controlled analgesia include programming errors , invasive access , and impairment of mobility .
BACKGROUND	This study evaluated an investigational sufentanil sublingual tablet system ( SSTS ) for the management of pain after knee or hip arthroplasty .
METHODS	This prospective , randomized , parallel-arm , double-blind study randomized postoperative patients at 34U .
METHODS	S. sites to receive SSTS 15 g ( n = 315 ) or an identical placebo system ( n = 104 ) and pain scores were recorded for up to 72h .
METHODS	Adult patients with American Society of Anesthesiologists status 1 to 3 after primary total unilateral knee or hip replacement under general anesthesia or with spinal anesthesia that did not include intrathecal opioids were eligible .
METHODS	Patients were excluded if they were opioid tolerant .
METHODS	The primary endpoint was the time-weighted summed pain intensity difference to baseline over 48h .
METHODS	Secondary endpoints included total pain relief , patient and healthcare professional global assessments , and patient and nurse ease-of-care questionnaires .
RESULTS	Summed pain intensity difference ( standard error ) was higher ( better ) in the SSTS group compared with placebo ( 76 [ 7 ] vs. -11 [ 11 ] , difference 88 [ 95 % CI , 66 to 109 ] ; P < 0.001 ) .
RESULTS	In the SSTS group , more patients and nurses responded `` good '' or `` excellent '' on the global assessments compared with placebo ( P < 0.001 ) .
RESULTS	Patient and nurse ease-of-care ratings for the system were high in both groups .
RESULTS	There was a higher incidence of nausea and pruritus in the SSTS group .
CONCLUSIONS	SSTS could be an effective patient-controlled pain management modality in patients after major orthopedic surgery and is easy to use by both patients and healthcare professionals .

###24530350
BACKGROUND	Adherence to pharmacological or non-pharmacological treatment of diabetes type 2 is fundamental in order to delay the onset of complications .
OBJECTIVE	To measure the effect of nursing educational support on compliance with treatment in patients with type 2 diabetes attending Regional Hospital Universitario of Colima , Mexico .
METHODS	An experimental , randomized study including outpatients with type 2 diabetes attending a Regional Hospital who agreed in writing to participate in the study .
METHODS	Nursing educational intervention sessions of three hours on two days a week for three months were provided .
METHODS	Adherence to treatment was assessed before and after intervention using the Scale for treatment adherence in type 2 diabetes ( EATDM-III ( ) ) .
METHODS	We performed two-proportion Z and p ; Risk Ratio and confidence interval 95 % and attributable fraction exposed .
RESULTS	e experimental group had 32 members , the same as the control .
RESULTS	After the intervention it was found that 16 members ( 50 % ) in the experimental group showed treatment adherence , unlike the control group where no one showed adherence to treatment , obtaining an independent two-proportion Z = 4.62 , P = .0000 , Risk Ratio = 65 ; Confidence Interval 95 % = 3.67 to 1152.38 ; exposed attributable fraction = 98.46 % .
CONCLUSIONS	The intervention was effective for the adherence of treatment .

###24489043
BACKGROUND	We report the main results , among adults , of a cluster-randomised-trial of Well London , a community-engagement programme promoting healthy eating , physical activity and mental well-being in deprived neighbourhoods .
BACKGROUND	The hypothesis was that benefits would be neighbourhood-wide , and not restricted to intervention participants .
BACKGROUND	The trial was part of a multicomponent process/outcome evaluation which included non-experimental components ( self-reported behaviour change amongst participants , case studies and evaluations of individual projects ) which suggested health , well-being and social benefits to participants .
METHODS	Twenty matched pairs of neighbourhoods in London were randomised to intervention/control condition .
METHODS	Primary outcomes ( five portions fruit/vegetables/day ; 530m of moderate intensity physical activity/week , abnormal General Health Questionnaire ( GHQ ) -12 score and Warwick-Edinburgh Mental Well-being Scale ( WEMWBS ) score ) were measured by postintervention questionnaire survey , among 3986 adults in a random sample of households across neighbourhoods .
RESULTS	There was no evidence of impact on primary outcomes : healthy eating ( relative risk [ RR ] 1.04 , 95 % CI 0.93 to 1.17 ) ; physical activity ( RR :1.01 , 95 % CI 0.88 to 1.16 ) ; abnormal GHQ12 ( RR :1.15 , 95 % CI 0.84 to 1.61 ) ; WEMWBS ( mean difference [ MD ] : -1.52 , 95 % CI -3.93 to 0.88 ) .
RESULTS	There was evidence of impact on some secondary outcomes : reducing unhealthy eating-score ( MD : -0.14 , 95 % CI -0.02 to 0.27 ) and increased perception that people in the neighbourhood pulled together ( RR : 1.92 , 95 % CI 1.12 to 3.29 ) .
CONCLUSIONS	The trial findings do not provide evidence supporting the conclusion of non-experimental components of the evaluation that intervention improved health behaviours , well-being and social outcomes .
CONCLUSIONS	Low participation rates and population churn likely compromised any impact of the intervention .
CONCLUSIONS	Imprecise estimation of outcomes and sampling bias may also have influenced findings .
CONCLUSIONS	There is a need for greater investment in refining such programmes before implementation ; new methods to understand , longitudinally different pathways residents take through such interventions and their outcomes , and new theories of change that apply to each pathway .

###26152131
OBJECTIVE	Two phase I studies in healthy Chinese ( NCT01458743 ) and Western ( NCT01612507 ) subjects evaluated the pharmacokinetics ( PK ) and safety of single and multiple ceftaroline fosamil 600 mg infusions administered every 8 or 12 hours ( q8h or q12h ) .
METHODS	Each study enrolled subjects sequentially into 1 of 2 cohorts ( cohort 1 : 60-minute infusions ; cohort 2 : 120-minute infusions ) .
METHODS	All subjects in the Chinese ( n = 26 ) study received open label ceftaroline fosamil ; in the Western study , subjects ( n = 41 ) in each cohort were randomized 3 : 1 to ceftaroline fosamil or placebo infusions .
METHODS	Single infusions were administered on days 1 and 8 .
METHODS	On days 2 - 7 ( 3 - 7 for Chinese study , cohort 1 ) subjects received q12h or q8h infusions .
METHODS	Plasma and urine were collected on days 1 and 8 for PK analysis .
RESULTS	Ceftaroline PK was linear and time-independent following single and multiple doses of ceftaroline fosamil .
RESULTS	The magnitude and timing of peak plasma concentrations of ceftaroline ( active metabolite ) , ceftaroline fosamil ( prodrug ) , and ceftaroline M-1 ( inactive metabolite ) varied according to the ceftaroline fosamil dosing schedule ( q12h or q8h ) and infusion duration ( 60 minutes or 120 minutes ) , but overall plasma ceftaroline exposures within the respective dosing intervals were broadly similar across cohorts .
RESULTS	The most frequent adverse events were rash/drug eruption , most of which were of mild-moderate intensity and considered related to treatment .
CONCLUSIONS	Ceftaroline PK was broadly similar in healthy Chinese and Western subjects receiving equivalent dose regimens .
CONCLUSIONS	The tolerability profile of ceftaroline fosamil in Chinese and Western subjects was consistent with previous clinical trials .

###24950747
BACKGROUND	Pharmacologic treatment options for posttraumatic stress disorder ( PTSD ) are limited in number and effectiveness .
BACKGROUND	Medications currently in use to treat PTSD were originally approved based on their efficacy in other disorders , such as major depression .
BACKGROUND	Substantial research in PTSD suggests that increased activity of corticotropin releasing hormone ( CRH ) - containing circuits are involved in the pathophysiology of the disease .
BACKGROUND	This Phase II trial aims to evaluate the efficacy of a CRH type 1 receptor ( CRHR1 ) antagonist in the treatment of PTSD .
METHODS	Currently untreated adult women , ages 18 to 65years , with a primary psychiatric diagnosis of PTSD of at least 3months ' duration , are being enrolled in a parallel-group , double-blind , placebo-controlled , randomized clinical trial evaluating the efficacy and safety of GSK561679 , a novel CRHR1 receptor antagonist .
METHODS	GSK561679 ( or matching placebo ) is prescribed at a fixed dose of 350mg nightly for six weeks .
METHODS	The primary trial hypothesis is that GSK561679 will reduce symptoms of PTSD , as measured by the Clinician-Administered PTSD Scale ( CAPS ) , significantly more than placebo after six weeks of treatment .
METHODS	Putative biological markers of PTSD which may influence treatment response are measured prior to randomization and after five weeks ' exposure to the study medication , including : fear conditioning and extinction using psychophysiological measures ; variants of stress-related genes and gene expression profiles ; and indices of HPA axis reactivity .
METHODS	In addition , the impact of PTSD and treatment on neuropsychological performance and functional capacity are assessed at baseline and after the fifth week of study medication .
METHODS	After completion of the six-week double blind treatment period , subjects enter a one-month follow-up period to monitor for sustained response and resolution of any adverse effects .
CONCLUSIONS	Considerable preclinical and human research supports the hypothesis that alterations in central nervous system CRH neuronal activity are a potential mediator of PTSD symptoms .
CONCLUSIONS	This study is the first to assess the efficacy of a specific antagonist of a CRH receptor in the treatment of PTSD .
CONCLUSIONS	Furthermore , the biological and neuropsychological measures included in this trial will substantially inform our understanding of the mechanisms of PTSD .
BACKGROUND	Clinicaltrials.gov Identifier : NCT01018992.Registered 6 November 2009 .
BACKGROUND	First patient randomized 14 January 2010 .

###24259265
BACKGROUND	This study evaluates the impact of the duration of pre-existing peripheral neuropathic pain on the therapeutic response to the capsaicin 8 % cutaneous patch .
METHODS	The non-interventional QUEPP ( QUTENZA - safety and effectiveness in peripheral neuropathic pain ) study evaluated the effectiveness of Qutenza ( TM ) in 1044 non-diabetic patients with peripheral neuropathic pain , who received a single application .
METHODS	Follow-up visits were scheduled at weeks 1-2 , 4 , 8 and 12 .
METHODS	A pre-defined co-analysis of changes in average pain intensity was performed based on the duration of pre-existing pain .
RESULTS	In patients with pre-existing pain for < 6 months , the mean relative change of the numeric pain rating scale score on days 7-14 to week 12 versus baseline was -36.6 % [ 4.6 standard error of the mean ( SEM ) ; n = 105 ] , -25.1 % ( 1.9 SEM ; n = 311 ) in patients with pain duration of 6 months to 2 years , -22.3 % ( 1.6 SEM ; n = 391 ) in patients with pain for > 2-10 years , and -19.2 % ( 2.6 SEM ; n = 99 ) in patients with pain for > 10 years .
RESULTS	Thirty percent and 50 % responder rates were 61.7 % and 39.3 % in patients with pre-existing pain for < 6 months , 42.3 % and 23.3 % in patients with pain for 6 months to 2 years , 40.9 % and 21.6 % in patients with pain for > 2-10 years , and 32.3 % and 14.1 % in patients with pain for > 10 years .
CONCLUSIONS	The highest treatment response to the capsaicin 8 % cutaneous patch was observed in patients with a history of pre-existing peripheral neuropathic pain of less than 6 months , suggesting that early initiation of topical treatment might be indicated .

###25193529
OBJECTIVE	Longitudinal evidence linking diabetic retinopathy with changes in brain structure and cognition is sparse .
OBJECTIVE	We used data from the Action to Control Cardiovascular Risk in Diabetes ( ACCORD ) trial to determine whether diabetic retinopathy at baseline predicted changes in brain structure or cognition 40 months later .
METHODS	Participants from the ACCORD-MIND and ACCORD-Eye substudies were included in analyses of cognition ( n = 1,862 ) and MRI-derived brain variables ( n = 432 ) .
METHODS	Retinopathy was categorized as none , mild nonproliferative , or moderate/severe .
METHODS	Tests of cognition included the Mini-Mental State Examination ( MMSE ) , Digit Symbol Substitution Test ( DSST ) , Rey Auditory Verbal Learning Test , and Stroop test .
METHODS	Primary brain outcomes were gray matter and abnormal white matter volumes .
RESULTS	Baseline retinopathy was associated with lower gray matter volume ( adjusted means of 470 , 466 , and 461 cm ( 3 ) for none , mild , and moderate/severe retinopathy , respectively ; P = 0.03 ) .
RESULTS	Baseline retinopathy also predicted a greater change in MMSE and DSST scores at 40 months in each retinopathy category ( MMSE : -0.20 , -0.57 , and -0.42 , respectively [ P = 0.04 ] ; DSST : -1.30 , -1.84 , and -2.89 , respectively [ P = 0.01 ] ) .
CONCLUSIONS	Diabetic retinopathy is associated with future cognitive decline in people with type 2 diabetes .
CONCLUSIONS	Although diabetic retinopathy is not a perfect proxy for diabetes-related brain and cognitive decline , patients with type 2 diabetes and retinopathy represent a subgroup at higher risk for future cognitive decline .

###24940942
OBJECTIVE	The superiority of conventional polyethylene glycol ( PEG ) solution over sodium picosulfate with magnesium citrate ( SPMC ) for bowel preparation remains controversial .
OBJECTIVE	Therefore , this study compared the efficacy , safety , and tolerability of different regimens of SPMC and PEG solution in Koreans , who consume a traditional high-fiber diet .
METHODS	A total of 200 outpatients undergoing elective colonoscopy were randomized into four groups receiving different bowel-preparation regimens in a prospective study : 4 L PEG in the morning on the day of colonoscopy , two 2 L split doses of PEG , split doses of 2 SPMC sachets , and split doses of 3 SPMC sachets .
METHODS	Bowel cleansing efficacy was assessed based on the Ottawa bowel preparation scale and the Aronchick scale by endoscopists blinded to treatment , and patients filled out a questionnaire to determine satisfaction .
RESULTS	There was no difference among groups with respect to bowel cleansing grade ( Ottawa scale , p = 0.314 ) .
RESULTS	Patients in the SPMC groups were less likely to have abdominal fullness , pain , nausea , or vomiting than patients in the PEG groups ( p < 0.05 ) .
RESULTS	Patients reported SPMC was more palatable than PEG .
RESULTS	There were no significant differences among groups with respect to polyp detection rate .
CONCLUSIONS	SPMC is as effective as conventional high-volume PEG-electrolyte solution in Korean patients .
CONCLUSIONS	SPMC groups reported superior palatability and tolerability compared to PEG groups .

###25952354
BACKGROUND	Information and behaviour can spread through interpersonal ties .
BACKGROUND	By targeting influential individuals , health interventions that harness the distributive properties of social networks could be made more effective and efficient than those that do not .
BACKGROUND	Our aim was to assess which targeting methods produce the greatest cascades or spillover effects and hence maximise population-level behaviour change .
METHODS	In this cluster randomised trial , participants were recruited from villages of the Department of Lempira , Honduras .
METHODS	We blocked villages on the basis of network size , socioeconomic status , and baseline rates of water purification , for delivery of two public health interventions : chlorine for water purification and multivitamins for micronutrient deficiencies .
METHODS	We then randomised villages , separately for each intervention , to one of three targeting methods , introducing the interventions to 5 % samples composed of either : randomly selected villagers ( n = 9 villages for each intervention ) ; villagers with the most social ties ( n = 9 ) ; or nominated friends of random villagers ( n = 9 ; the last strategy exploiting the so-called friendship paradox of social networks ) .
METHODS	Participants and data collectors were not aware of the targeting methods .
METHODS	Primary endpoints were the proportions of available products redeemed by the entire population under each targeting method .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT01672580 .
RESULTS	Between Aug 4 , and Aug 14 , 2012 , 32 villages in rural Honduras ( 25-541 participants each ; total study population of 5773 ) received public health interventions .
RESULTS	For each intervention , nine villages ( each with 1-20 initial target individuals ) were randomised , using a blocked design , to each of the three targeting methods .
RESULTS	In nomination-targeted villages , 951 ( 743 % ) of 1280 available multivitamin tickets were redeemed compared with 940 ( 662 % ) of 1420 in randomly targeted villages and 744 ( 610 % ) of 1220 in indegree-targeted villages .
RESULTS	All pairwise differences in redemption rates were significant ( p < 001 ) after correction for multiple comparisons .
RESULTS	Targeting nominated friends increased adoption of the nutritional intervention by 122 % compared with random targeting ( 95 % CI 69-179 ) .
RESULTS	Targeting the most highly connected individuals , by contrast , produced no greater adoption of either intervention , compared with random targeting .
CONCLUSIONS	Introduction of a health intervention to the nominated friends of random individuals can enhance that intervention 's diffusion by exploiting intrinsic properties of human social networks .
CONCLUSIONS	This method has the additional advantage of scalability because it can be implemented without mapping the network .
CONCLUSIONS	Deployment of certain types of health interventions via network targeting , without increasing the number of individuals targeted or the resources used , could enhance the adoption and efficiency of those interventions , thereby improving population health .
BACKGROUND	National Institutes of Health , The Bill & Melinda Gates Foundation , Star Family Foundation , and the Canadian Institutes of Health Research .

###25630368
BACKGROUND	Malnourished HIV-infected African adults are at high risk of early mortality after starting antiretroviral therapy ( ART ) .
BACKGROUND	We hypothesized that short-course , high-dose vitamin and mineral supplementation in lipid nutritional supplements would decrease mortality .
METHODS	The study was an individually-randomised phase III trial conducted in ART clinics in Mwanza , Tanzania , and Lusaka , Zambia .
METHODS	Participants were 1,815 ART-nave non-pregnant adults with body mass index ( BMI ) < 18.5 kg/m who were referred for ART based on CD4 count < 350 cells/L or WHO stage 3 or 4 disease .
METHODS	The intervention was a lipid-based nutritional supplement either without ( LNS ) or with additional vitamins and minerals ( LNS-VM ) , beginning prior to ART initiation ; supplement amounts were 30 g/day ( 150 kcal ) from recruitment until 2 weeks after starting ART and 250 g/day ( 1,400 kcal ) from weeks 2 to 6 after starting ART .
METHODS	The primary outcome was mortality between recruitment and 12 weeks of ART .
METHODS	Secondary outcomes were serious adverse events ( SAEs ) and abnormal electrolytes throughout , and BMI and CD4 count at 12 weeks ART .
RESULTS	Follow-up for the primary outcome was 91 % .
RESULTS	Median adherence was 66 % .
RESULTS	There were 181 deaths in the LNS group ( 83.7 / 100 person-years ) and 184 ( 82.6 / 100 person-years ) in the LNS-VM group ( rate ratio ( RR ) , 0.99 ; 95 % CI , 0.80-1 .21 ; P = 0.89 ) .
RESULTS	The intervention did not affect SAEs or BMI , but decreased the incidence of low serum phosphate ( RR , 0.73 ; 95 % CI , 0.55-0 .97 ; P = 0.03 ) and increased the incidence of high serum potassium ( RR , 1.60 ; 95 % CI , 1.19-2 .15 ; P = 0.002 ) and phosphate ( RR , 1.23 ; 95 % CI , 1.10-1 .37 ; P < 0.001 ) .
RESULTS	Mean CD4 count at 12 weeks post-ART was 25 cells/L ( 95 % CI , 4-46 ) higher in the LNS-VM compared to the LNS arm ( P = 0.02 ) .
CONCLUSIONS	High-dose vitamin and mineral supplementation in LNS , compared to LNS alone , did not decrease mortality or clinical SAEs in malnourished African adults initiating ART , but improved CD4 count .
CONCLUSIONS	The higher frequency of elevated serum potassium and phosphate levels suggests high-level electrolyte supplementation for all patients is inadvisable but the addition of micronutrient supplements to ART may provide clinical benefits in these patients .
BACKGROUND	PACTR201106000300631 , registered on 1st June 2011 .

###24311515
METHODS	Eicosapentaenoic acid ( EPA ) , abundant in oily fish , is reported to reduce skin inflammation and provide photoprotection , potential mechanisms include competition with arachidonic acid ( AA ) for metabolism by cyclooxygenases/lipoxygenases to less pro-inflammatory mediators .
METHODS	We thus examine impact of EPA intake on levels of AA , EPA and their resulting eicosanoids in human skin with or without ultraviolet radiation ( UVR ) challenge .
RESULTS	In a double-blind randomised controlled study , 79 females took 5 g EPA-rich or control lipid for 12 wk .
RESULTS	Pre - and post-supplementation , red blood cell and skin polyunsaturated fatty acids were assessed by GC , and eicosanoids from unexposed and UVR-exposed skin by LC-MS/MS .
RESULTS	Active supplementation increased red blood cell and dermal EPA versus control ( both p < 0.001 ) , lowering relative AA : EPA content ( 4:1 versus 15:1 and 5:1 versus 11:1 , respectively ; both p < 0.001 ) .
RESULTS	Pre-supplementation , UVR increased PGE2 , 12-hydroxyeicosatetraenoic acids , 12-HEPE ( all p < 0.001 ) and PGE3 ( p < 0.05 ) .
RESULTS	Post-EPA , PGE2 was reduced in unchallenged skin ( p < 0.05 ) while EPA-derived PGE3 ( non-sign ) and 12-HEPE ( p < 0.01 ) were elevated post-UVR .
RESULTS	Thus , post-EPA , PGE2 : PGE3 was lower in unchallenged ( 12:1 versus 28:1 ; p < 0.05 ) and UVR exposed ( 12:1 versus 54:1 ; p < 0.01 ) skin ; 12-hydroxyeicosatetraenoic acids :12 - HEPE was lower in UVR-exposed skin ( 3:1 versus 11:1 ; p < 0.001 ) .
CONCLUSIONS	Dietary EPA augments skin EPA : AA content , shifting eicosanoid synthesis towards less pro-inflammatory species , and promoting a regulatory milieu under basal conditions and in response to inflammatory insult .

###24224396
OBJECTIVE	We compared the efficacies of cold knife excision and carbon dioxide ( CO2 ) laser fiber excision of oral cavity leukoplakia .
METHODS	Between August 2009 and June 2011,45 patients who underwent excision of oral cavity leukoplakia were assessed for operative time , use of bipolar cautery , blood loss , and number of intraoperative margins needed .
METHODS	Patients were assigned randomly to either a cold knife group ( 23 procedures ) or a CO2 laser fiber group ( 24 procedures ) at the time of the procedure .
RESULTS	The times of excision were similar in the CO2 laser fiber group ( 1.64 min/cm2 ) and the cold knife group ( 1.70 min/cm2 ) .
RESULTS	There were large differences between the CO2 laser fiber group and the cold knife group in the categories of bipolar cautery uses per square centimeter ( 0.34 uses versus 3.32 uses ) and blood loss ( 0.19 g/cm2 versus 2.55 g/cm2 ) .
RESULTS	The average number of margins needed to clear a specimen by frozen section was 1.21 for the CO2 laser fiber group and 1.83 for the cold knife group .
CONCLUSIONS	The CO2 laser fiber did not show an advantage in operative time .
CONCLUSIONS	The CO2 laser fiber did show better outcomes in the areas of blood loss , bipolar cautery use , and intraoperative margins needed .

###25597457
BACKGROUND	Research has shown that auditory training improves auditory sensory skills ; however , it is unclear whether this improvement is transferred to top-down skills , such as memory , attention , and language , and whether it depends on group characteristics in regard to memory and attention skills .
OBJECTIVE	The primary goal of this research was to investigate the generalization of learning from auditory sensory skills to top-down skills such as memory , attention , and language .
OBJECTIVE	We also aimed to compare whether this generalization process occurs in the same way among typically developing children and children with speech sound disorder .
METHODS	This study was a randomized controlled trial .
METHODS	Typically developing 7 - to 12-yr-old children and children with speech sound disorder were separated into four groups : a trained control group ( TDT ; n = 10 , age 9.6 2.0 yr ) , a nontrained control group ( TDNT ; n = 11 , age 8.2 1.6 yr ) , a trained study group ( SSDT ; n = 10 , age 7.7 1.2 yr ) , and a nontrained study group ( SSDNT ; n = 8 , age 8.6 1.2 yr ) .
METHODS	Both trained groups underwent a computerized , nonverbal auditory training that focused on frequency discrimination , ordering , and backward-masking tasks .
METHODS	The training consisted of twelve 45 min sessions , once a week , for a total of 9 hr of training , approximately .
METHODS	Near-transfer ( Gap-In-Noise [ GIN ] and Frequency Pattern Test ) and far-transfer measures ( auditory and visual sustained attention tests , phonological working memory and language tests ) were applied before and after training .
METHODS	The results were analyzed using a 2 2 2 mixed-model analysis of variance with the group and training as the between-group variables and the period as the within-group variable .
METHODS	The significance threshold was p 0.05 .
RESULTS	There was a group period training interaction for GIN [ F ( 1.35 ) = 7.18 , p = 0.011 ] , indicating a significant threshold reduction only for the TDT group ( Tukey multiple comparisons ) .
RESULTS	There was a significant group period interaction [ F ( 1.35 ) = 5.52 , p = 0.025 ] and a training period interaction for visual reaction time [ F ( 1.35 ) = 4.20 , p = 0.048 ] , indicating improvement in the SSDT group and worsening in both nontrained groups .
RESULTS	There was also a significant group training period interaction [ F ( 1.35 ) = 4.27 , p = 0.046 ] for the auditory false alarms , with a significant improvement after training only for the SSDT group .
RESULTS	Analysis of variance also revealed that all groups exhibited approximately the same level of gains for all measures , except for GIN [ F ( 3,38 ) = 4.261 , p = 0.011 ] and visual response time [ F ( 3.38 ) = 4.069 , p = 0.014 ] .
CONCLUSIONS	After training , the TDT group demonstrated a significant improvement for GIN and the SSDT exhibited the same for sustained attention , indicating learning generalization from an auditory sensory training to a top-down skill .
CONCLUSIONS	For the other measures , all groups exhibited approximately the same level of gains , indicating the presence of a test-retest effect .
CONCLUSIONS	Our findings also show that the memory span was not related to the learning generalization process given that the SSDT exhibited a more pronounced gain in attention skills after the sensory training .

###25066921
BACKGROUND	Although meditation therapies such as the Transcendental Meditation ( TM ) technique are commonly used to assist with stress and stress-related diseases , there remains a lack of rigorous clinical trial research establishing the relative efficacy of these treatments overall and for populations with psychiatric illness .
BACKGROUND	This study uses a comparative effectiveness design to assess the relative benefits of TM to those obtained from a gold-standard cognitive behavioral therapy for posttraumatic stress disorder ( PTSD ) in a Veteran population .
METHODS	This paper describes the rationale and design of an in progress randomized controlled trial comparing TM to an established cognitive behavioral treatment - Prolonged Exposure ( PE ) - and an active control condition ( health education [ HE ] ) for PTSD .
METHODS	This trial will recruit 210 Veterans meeting DSM-IV criteria for PTSD , with testing conducted at 0 and 3 months for PTSD symptoms , depression , mood disturbance , quality of life , behavioral factors , and physiological/biochemical and gene expression mechanisms using validated measures .
METHODS	The study hypothesis is that TM will be noninferior to PE and superior to HE on changes in PTSD symptoms , using the Clinician Administered PTSD Scale ( CAPS ) .
CONCLUSIONS	The described study represents a methodologically rigorous protocol evaluating the benefits of TM for PTSD .
CONCLUSIONS	The projected results will help to establish the overall efficacy of TM for PTSD among Veterans , identify bio-behavioral mechanisms through which TM and PE may improve PTSD symptoms , and will permit conclusions regarding the relative value of TM against currently established therapies for PTSD .

###24730708
BACKGROUND	Autism spectrum disorder ( ASD ) is a neurodevelopmental disorder characterized by social communication impairments and restricted , repetitive behaviors .
BACKGROUND	Whereas current pharmacological interventions for ASD focus primarily on psychiatric symptoms , including agitation and obsessive behaviors , few agents target core symptomatology .
BACKGROUND	It has been previously hypothesized that abnormalities in facial scanning , such as reduced eye contact or increased mouth fixation , contribute to social communication deficits in ASD .
BACKGROUND	In addition , previous reports have suggested elevated stress and anxiety in ASD , symptoms that are believed to impact facial scanning patterns .
OBJECTIVE	The present pilot study sought to explore the effects of pharmacological intervention via propranolol , a nonselective - adrenergic antagonist and known anxiolytic , on facial scanning in ASD .
OBJECTIVE	Specifically , we wished to determine whether there is an increase in eye contact and a decrease in mouth fixation with administration of propranolol .
METHODS	A sample of 14 participants with ASD and 14 matched controls participated in two study sessions in which propranolol and placebo were administered in a counterbalanced , double-blinded manner .
METHODS	At each session , ocular fixation data were collected during presentation of video stimuli of 16 human faces .
METHODS	Fixation time on the eye , nose , and mouth regions of the face stimuli was analyzed .
RESULTS	The baseline fixation patterns for the ASD and control groups did not significantly differ ; however , administration of propranolol was associated with a significant reduction in mouth fixation for the ASD group .
RESULTS	Additionally , mouth fixation was positively related to nonverbal communication impairment in the ASD group .
CONCLUSIONS	Although eye fixation in ASD appears typical in the present study , the effect of propranolol in reducing mouth fixation suggests an important focus for further research .
CONCLUSIONS	Future studies are needed to better characterize the relationship between stress and anxiety and facial scanning in ASD , as well as the effects of pharmacological intervention .

###24813196
OBJECTIVE	Does the initiation of corifollitropin alfa administration on cycle day 4 instead of cycle day 2 result in a reduced total rFSH consumption in a GnRH antagonist protocol ?
CONCLUSIONS	Initiation of corifollitropin alfa on cycle day 4 compared with day 2 results in significantly reduced total rFSH consumption at the end of the follicular phase .
BACKGROUND	In vitro fertilization treatment is associated with significant physical , psychological and emotional stress in infertile patients .
BACKGROUND	This notion has fuelled the search for simplified treatment approaches that may reduce the treatment burden .
BACKGROUND	The introduction of corifollitropin alfa has provided a more patient-friendly treatment protocol because it obviates the need for daily hormonal injections .
BACKGROUND	In addition , postponing the initiation of hormonal stimulation should also reduce the total gonadotrophin consumption and the number of injections needed .
METHODS	A prospective randomized controlled pilot study was conducted in a university centre in Belgium .
METHODS	Between December 2011 and March 2013 , 59 patients were randomized in the study and 52 of these patients received the allocated intervention .
METHODS	All patients were randomly assigned to the control group ( CD2 ) , with initiation of corifollitropin alfa on cycle day 2 , or to the study group ( CD4 ) with initiation of stimulation on day 4 .
METHODS	The GnRH antagonist was administered from cycle day 7 onwards in both treatment arms .
METHODS	The main outcome measure was the total rFSH consumption at the end of the follicular phase after corifollitropin alfa treatment .
RESULTS	The total dose of rFSH at the end of the follicular phase was significantly reduced in the CD4 group compared with the CD2 group ( 324 ( 276 ) IU in the CD2 group versus 173 ( 255 ) IU in the CD4 group , P = 0.015 , mean difference -151 , 95 % confidence interval ( CI ) -301 to -1 ) .
RESULTS	A significant reduction of total duration of rFSH stimulation in the CD4 group was also observed ( 8.6 ( 1.4 ) days in CD2 group versus 7.8 ( 1.2 ) days in the CD4 group , P = 0.008 , mean difference -0.8 , 95 % CI -1.6 to -0.1 ) .
RESULTS	The number of cumulus-oocyte-complexes was comparable in both treatment groups ( 12.8 ( 7.3 ) in CD2 group versus 14.7 ( 8.8 ) in the CD4 group , P = 0.461 , mean difference 1.8 , 95 % CI -2.7 to 6.4 ) .
RESULTS	Ongoing pregnancy rates of 48 % in the CD2 group and 41 % in the CD4 group were achieved ( P = 0.60 , relative risk ( RR ) 0.85 , 95 % CI 0.46-1 .56 ) .
RESULTS	Final oocyte maturation was triggered with GnRH agonist instead of hCG in two patients in the CD2 group and in eight patients in the CD4 group , because of an increased risk of ovarian hyperstimulation syndrome ( P = 0.078 , RR 3.7 ( 95 % CI 0.88-15 .8 ) .
CONCLUSIONS	Before general implementation can be advised , this trial should be validated in a much larger randomized trial .
CONCLUSIONS	WIDER IMPLICATIONS OF THE FINDINGS If the approach of starting ovarian stimulation on Day 4 of the cycle could be implemented in a large population of infertile patients , it would result in a significant reduction of gonadotrophin consumption .
BACKGROUND	No external finance was involved in this study .
BACKGROUND	C.B and N.P.P. have received fees from MSD .
BACKGROUND	Otherwise the authors declare no conflict of interest regarding this study .
BACKGROUND	The trial was registered at clinicaltrials.gov ( NCT01633580 ) .

###24628789
BACKGROUND	The pandemic potential of avian influenza A/H5N1 should not be overlooked , and the continued development of vaccines against these highly pathogenic viruses is a public health priority .
METHODS	This open-label extension booster study followed a Phase III study of 1206 adults who had received two 3.75 g doses of primary AS03A-adjuvanted or non-adjuvanted H5N1 split-virus vaccine ( A/Vietnam/1194 / 2004 ; clade 1 ) ( NCT00449670 ) .
METHODS	The aim of the extension study was to evaluate different timings for heterologous AS03A-adjuvanted booster vaccination ( A/Indonesia/5 / 2005 ; clade 2.1 ) given at Month 6 , 12 , or 36 post-primary vaccination .
METHODS	Immunogenicity was assessed 21days after each booster vaccination and the persistence of immune responses against the primary vaccine strain ( A/Vietnam ) and the booster strain ( A/Indonesia ) was evaluated up to Month 48 post-primary vaccination .
METHODS	Reactogenicity and safety were also assessed .
RESULTS	After booster vaccination given at Month 6 , HI antibody responses to primary vaccine , and booster vaccine strains were markedly higher with one dose of AS03A-H5N1 booster vaccine in the AS03A-adjuvanted primary vaccine group compared with two doses of booster vaccine in the non-adjuvanted primary vaccine group .
RESULTS	HI antibody responses were robust against the primary and booster vaccine strains 21days after boosting at Month 12 or 36 .
RESULTS	At Month 48 , in subjects boosted at Month 6 , 12 , or 36 , HI antibody titers of 1:40 against the booster strain persisted in 39.2 % , 61.2 % , and 95.6 % of subjects , respectively .
RESULTS	Neutralizing antibody responses and cell-mediated immune responses also showed that AS03A-H5N1 heterologous booster vaccination elicited robust immune responses within 21days of boosting at Month 6 , 12 , or 36 post-primary vaccination .
RESULTS	The booster vaccine was well tolerated , and no safety concerns were raised .
CONCLUSIONS	In Asian adults primed with two doses of AS03A-adjuvanted H5N1 pandemic influenza vaccine , strong cross-clade anamnestic antibody responses were observed after one dose of AS03A-H5N1 heterologous booster vaccine given at Month 6 , 12 , or 36 after priming , suggesting that AS03A-adjuvanted H5N1 vaccines may provide highly flexible prime-boost schedules .
CONCLUSIONS	Although immunogenicity decreased with time , vaccinated populations could potentially be protected for up to three years after vaccination , which is likely to far exceed the peak of the a pandemic .

###24553033
OBJECTIVE	Labor is one of the most painful experiences a woman may face during her lifetime .
OBJECTIVE	One of the most effective methods used for eliminating this pain is epidural analgesia .
OBJECTIVE	The aim of this study to determine the impact of adding morphine to low-dose bupivacaine epidural anesthesia on labor and neonatal outcomes , and maternal side effects .
METHODS	This is a prospective randomized double-blind study comparing two regimens of anesthetic agents used for epidural anesthesia in labor .
METHODS	A total of 120 pregnant women were randomized into two groups with 60 subjects in each study arm .
METHODS	A catheter was inserted , and 0.1 % bupivacaine + 2 g/mL fentanyl in 15 mL saline were given to Group bupivacaine-fentanyl ( Group BF ) , while 0.0625 % bupivacaine + 2 g/ml fentanyl + 2 mg morphine in 15 mL saline were given to Group bupivacaine-fentanyl-morphine ( Group BFM ) with no test dosing from the needle .
METHODS	No morphine was added to the subsequent epidural injections in Group BFM .
RESULTS	The total dose of bupivacaine was significantly lower in Group BFM relative to Group BF ( P = 0.0001 ) .
RESULTS	The visual analogu scalescores at 15 , 30 , and 45 min were significantly lower in Group BF compared to thosein Group BFM ( P = 0.0001 , P = 0.001 , and P = 0.006 , respectively ) .
RESULTS	The second stage of labor was significantly shorter in Group BFM relative to Group BF ( P = 0.027 and P = 0.003 , respectively ) .
RESULTS	The satisfaction with analgesia following the first dose was higher in the nonmorphine group ( P = 0.0001 ) .
RESULTS	However , maternal postpartum satisfaction was similar in both groups .
RESULTS	Either nausea or vomiting was recorded in eight patients in Group BFM .
CONCLUSIONS	We believe that epidural analgesia comprised of a low-dose local anaesthetic and 2 mg morphine provides a painless labor that significantly reducesthe use of local anesthetic without changing the efficiency of the analgesic , ensuring the mother 's satisfaction without leading to an adverse effect on the mother or foetus , while mildly ( but significantly ) shortening the second stage of labor .

###24980467
OBJECTIVE	This phase III study assessed the safety and immunogenicity of MenACWY-CRM , a quadrivalent meningococcal conjugate vaccine , administered with routine vaccines starting at 2 months of age .
METHODS	Healthy infants received MenACWY-CRM in a two - or three-dose primary infant series plus a single toddler dose .
METHODS	In addition , a two-dose toddler catch-up series was evaluated .
METHODS	Immune responses to MenACWY-CRM were assessed for serum bactericidal activity with human complement ( hSBA ) .
METHODS	Reactogenicity and safety results were collected systematically .
RESULTS	After a full infant/toddler series or two-dose toddler catch-up series , MenACWY-CRM elicited immune responses against the four serogroups in 94-100 % of subjects .
RESULTS	Noninferiority of the two - versus three-dose MenACWY-CRM infant dosing regimen was established for geometric mean titers for all serogroups .
RESULTS	Following the three-dose infant primary series , 89-98 % of subjects achieved an hSBA 8 across all serogroups .
RESULTS	Immune responses to concomitant routine vaccines given with MenACWY-CRM were noninferior to responses to routine vaccines alone , except for pertactin after the two-dose infant series .
RESULTS	Noninferiority criteria were met for all concomitant antigens after the three-dose infant series .
CONCLUSIONS	MenACWY-CRM vaccination regimens in infants and toddlers were immunogenic and well tolerated .
CONCLUSIONS	No clinically meaningful effects of concomitant administration with routine infant and toddler vaccines were observed .

###24400838
BACKGROUND	Teacher training may improve teaching effectiveness , but it might also have paradoxical effects .
BACKGROUND	Research on expertise development suggests that the integration of new strategies may result in a temporary deterioration of performance until higher levels of competence are reached .
BACKGROUND	In this study , the impact of a clinical teacher training on teaching effectiveness was assessed in an intensive course in emergency medicine .
BACKGROUND	As primary study outcome students ' practical skills at the end of their course were chosen .
METHODS	The authors matched 18 clinical teachers according to clinical experience and teaching experience and then randomly assigned them to a two-day-teacher training , or no training .
METHODS	After 14 days , both groups taught within a 12-hour intensive course in emergency medicine for undergraduate students .
METHODS	The course followed a clearly defined curriculum .
METHODS	After the course students were assessed by structured clinical examination ( SCE ) and MCQ .
METHODS	The teaching quality was rated by students using a questionnaire .
RESULTS	Data for 96 students with trained teachers , and 97 students with untrained teachers were included .
RESULTS	Students taught by untrained teachers performed better in the SCE domains ` alarm call ' ( p < 0.01 ) and ` ventilation ' ( p = 0.01 ) , while the domains ` chest compressions ' and ` use of automated defibrillator ' did not differ .
RESULTS	MCQ scores revealed no statistical difference .
RESULTS	Overall , teaching quality was rated significantly better by students of untrained teachers ( p = 0.05 ) .
CONCLUSIONS	At the end of a structured intensive course in emergency medicine , students of trained clinical teachers performed worse in 2 of 4 practical SCE domains compared to students of untrained teachers .
CONCLUSIONS	In addition , subjective evaluations of teaching quality were worse in the group of trained teachers .
CONCLUSIONS	Difficulties in integrating new strategies in their teaching styles might be a possible explanation .

###26406148
BACKGROUND	Nivolumab , a programmed death 1 ( PD-1 ) checkpoint inhibitor , was associated with encouraging overall survival in uncontrolled studies involving previously treated patients with advanced renal-cell carcinoma .
BACKGROUND	This randomized , open-label , phase 3 study compared nivolumab with everolimus in patients with renal-cell carcinoma who had received previous treatment .
METHODS	A total of 821 patients with advanced clear-cell renal-cell carcinoma for which they had received previous treatment with one or two regimens of antiangiogenic therapy were randomly assigned ( in a 1:1 ratio ) to receive 3 mg of nivolumab per kilogram of body weight intravenously every 2 weeks or a 10-mg everolimus tablet orally once daily .
METHODS	The primary end point was overall survival .
METHODS	The secondary end points included the objective response rate and safety .
RESULTS	The median overall survival was 25.0 months ( 95 % confidence interval [ CI ] , 21.8 to not estimable ) with nivolumab and 19.6 months ( 95 % CI , 17.6 to 23.1 ) with everolimus .
RESULTS	The hazard ratio for death with nivolumab versus everolimus was 0.73 ( 98.5 % CI , 0.57 to 0.93 ; P = 0.002 ) , which met the prespecified criterion for superiority ( P0 .0148 ) .
RESULTS	The objective response rate was greater with nivolumab than with everolimus ( 25 % vs. 5 % ; odds ratio , 5.98 [ 95 % CI , 3.68 to 9.72 ] ; P < 0.001 ) .
RESULTS	The median progression-free survival was 4.6 months ( 95 % CI , 3.7 to 5.4 ) with nivolumab and 4.4 months ( 95 % CI , 3.7 to 5.5 ) with everolimus ( hazard ratio , 0.88 ; 95 % CI , 0.75 to 1.03 ; P = 0.11 ) .
RESULTS	Grade 3 or 4 treatment-related adverse events occurred in 19 % of the patients receiving nivolumab and in 37 % of the patients receiving everolimus ; the most common event with nivolumab was fatigue ( in 2 % of the patients ) , and the most common event with everolimus was anemia ( in 8 % ) .
CONCLUSIONS	Among patients with previously treated advanced renal-cell carcinoma , overall survival was longer and fewer grade 3 or 4 adverse events occurred with nivolumab than with everolimus .
CONCLUSIONS	( Funded by Bristol-Myers Squibb ; CheckMate 025 ClinicalTrials.gov number , NCT01668784 . )

###25632741
OBJECTIVE	To study changes of plasma ADMA levels of patients with non-ST elevation myocardial infarction ( NSTEMI ) undergoing percutaneous coronary intervention ( PCI ) and to explore the effect of Salvia Miltiorrhiza ( SM ) on them .
METHODS	Totally 52 patients with confirmed NSTEMI undergoing PCI were randomly assigned to the SM treated group and the control group , 26 in each group .
METHODS	Patients in the SM treated group received the conventional therapy plus SM ( 1 g each time , three times per day till one month after PCI ) .
METHODS	Those in the control group only received the conventional therapy .
METHODS	Plasma ADMA levels were measured before PCI , and at day 1 and 30 after PCI .
RESULTS	Plasma ADMA levels in both group obviously decreased at day 30 after PCI with statistical difference ( P < 0.01 ) .
RESULTS	The decrement was more obviously seen in the SM treated group , with statistical difference when compared with the control group ( P < 0.01 ) .
CONCLUSIONS	Patients with NSTEMI undergoing PCI could have plasma ADMA levels decreased .
CONCLUSIONS	Administration of SM just before PCI might be associated with negative regulating plasma ADMA levels .

###24880672
OBJECTIVE	To assess treatment outcomes via acoustic voice laboratory measurements before and after intervention in patients with common voice problems and Determine if outcome sensitivity of certain voice laboratory measures varies with disorder type .
METHODS	Retrospective and single-blinded .
METHODS	In this study , 40 patients with a single voice disorder diagnosis of either benign vocal fold lesions ( lesions ) , primary muscle tension dysphonia ( MTD-1 ) , vocal fold atrophy ( atrophy ) or unilateral vocal fold paralysis ( UVFP ) underwent baseline testing , a single intervention-type ( phonosurgery/voice therapy ) , and follow-up testing at uniform time points .
METHODS	Ten patients per diagnosis group were analyzed before and after treatment .
METHODS	Time - and frequency-based acoustic measures taken from vowels and sentences as well as patient-perceptual analysis ( Voice Handicap Index-10 ) were reviewed .
RESULTS	Statistically significant improvements were observed for three of four groups .
RESULTS	Patients with muscle tension dysphonia displayed an improvement in Cepstral Spectral Index of Dysphonia speech ( CSID ) ( P < 0.05 ) .
RESULTS	Patients with lesions had improved Voice Handicap Index-10 ( P < 0.05 ) , cepstral peak prominence ( CPP ) vowel standard deviation ( P < 0.05 ) , and CPP speech ( P < 0.05 ) .
RESULTS	Patients with atrophy did not demonstrate significant improvement in any measure .
RESULTS	Patients with unilateral vocal fold paralysis showed an improvement in CSID speech ( P < 0.05 ) and CPP speech ( P < 0.05 ) .
RESULTS	In addition , strong effect sizes were observed for many of the acoustic parameters studied .
CONCLUSIONS	For all groups except atrophy , treatment was successful in improving patient perception of voice handicap and/or some acoustic voice parameters .
CONCLUSIONS	A disorder-specific response to frequency-based acoustic measures was found .

###24385406
BACKGROUND	Breakthrough cancer pain ( BTcP ) is recognized as a clinically significant complication of chronic cancer pain with most BTcP episodes peaking in intensity within a few minutes and lasting for approximately 30min .
BACKGROUND	Although a number of rapid-onset fentanyl preparations have been developed in the last decade , BTcP is still typically managed through the use of rescue doses of oral morphine but a comparative study of sublingual fentanyl and oral morphine is still lacking .
BACKGROUND	The aim of this study was to determine the efficacy , tolerability , and patient satisfaction of sublingual fentanyl citrate ( SLF ) and oral morphine solution ( OM ) in the treatment of BTcP .
METHODS	In this prospective , longitudinal , controlled-study , 40 patients with BTcP were allocated to receive oral morphine ( OM ) or sublingual fentanyl ( SLF ) .
METHODS	Pain intensity level on a 0-10 numerical rating visual analog scale ( VAS ) , frequency of BTcP throughout the day , onset of relief ( 0-5 , 6-10 , 11-15 , or over 16min ) , time required for dose titration , patient satisfaction and adverse effects were assessed at 3 , 7 , 15 , and 30days after starting the treatment .
RESULTS	Mean doses of opioids for BTcP were 23523.4 g ( SLF ) and 385.2 mg ( OM ) .
RESULTS	The mean pain intensity levels were significantly lower with SLF than OM at 3days ( 6.0 vs. 6.95 ; p = 0,001 ) , 7days ( 4.15 vs. 6.25 , p < 0.001 ) , 15days ( 3.45 vs. 5.35 , p < 0.001 ) , and 30days ( 3.05 vs. 4.45 , p < 0.001 ) .
RESULTS	SLF provided significantly faster relief for BTcP than OM ( p < 0.001 ) with a shorter dose titration period ( mean 6.63.3 vs. 13.34.9 days ; p < 0.001 ) and better satisfaction scores and with a very good safety profile .
CONCLUSIONS	Administration of SLF might provide a more effective treatment option than oral morphine for BTcP .

###24309370
BACKGROUND	Four cycles of etoposide plus cisplatin and accelerated hyperfractionated thoracic radiotherapy ( AHTRT ) is the standard of care for limited-stage small-cell lung cancer ( SCLC ) .
BACKGROUND	Irinotecan plus cisplatin significantly improved overall survival compared with etoposide plus cisplatin for extensive-stage SCLC .
BACKGROUND	We compared these regimens for overall survival of patients with limited-stage SCLC .
METHODS	We did this phase 3 study in 36 institutions in Japan .
METHODS	Eligibility criteria included age 20-70 years , Eastern Cooperative Oncology Group ( ECOG ) performance status of 0-1 , and adequate organ functions .
METHODS	Eligible patients with previously untreated limited-stage SCLC received one cycle of etoposide plus cisplatin ( intravenous etoposide 100 mg/m ( 2 ) on days 1-3 ; intravenous cisplatin 80 mg/m ( 2 ) on day 1 ) plus AHTRT ( 1.5 Gy twice daily , 5 days a week , total 45 Gy over 3 weeks ) .
METHODS	Patients without progressive disease following induction therapy were randomised ( 1:1 ratio , using a minimisation method with biased-coin assignment balancing on ECOG performance status [ 0 vs 1 ] , response to induction chemoradiotherapy [ complete response plus near complete response vs partial response and stable disease ] , and institution ) to receive either three further cycles of consolidation etoposide plus cisplatin or irinotecan plus cisplatin ( intravenous irinotecan 60 mg/m ( 2 ) on days 1 , 8 , 15 ; intravenous cisplatin 60 mg/m ( 2 ) on day 1 ) .
METHODS	Patients , physicians , and investigators were aware of allocation .
METHODS	The primary endpoint was overall survival after randomisation ; primary analysis was by intention to treat .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00144989 , and the UMIN Clinical Trials Registry , number C000000095 .
RESULTS	281 patients were enrolled between Sept 1 , 2002 , and Oct 2 , 2006 .
RESULTS	After induction etoposide plus cisplatin and AHTRT , 258 patients were randomised to consolidation etoposide plus cisplatin ( n = 129 ) or irinotecan plus cisplatin ( n = 129 ) .
RESULTS	In the etoposide plus cisplatin group , median overall survival was 3.2 years ( 95 % CI 2.4-4 .1 ) .
RESULTS	In the irinotecan and cisplatin group , median overall survival was 2.8 years ( 95 % CI 2.4-3 .6 ) ; overall survival did not differ between the two groups ( hazard ratio 1.09 [ 95 % CI 0.80-1 .46 ] , one-sided stratified log-rank p = 0.70 ) .
RESULTS	The most common adverse events of grade 3 or 4 were neutropenia ( 120 [ 95 % ] in the etoposide plus cisplatin group vs 101 [ 78 % ] in the irinotecan plus cisplatin group ) , anaemia ( 44 [ 35 % ] vs 50 [ 39 % ] ) , thrombocytopenia ( 26 [ 21 % ] vs six [ 5 % ] ) , febrile neutropenia ( 21 [ 17 % ] vs 18 [ 14 % ] ) , and diarrhoea ( two [ 2 % ] vs 13 [ 10 % ] ) .
RESULTS	There was one treatment-related adverse event leading to death in each group ( radiation pneumonitis in the etoposide plus cisplatin group ; brain infarction in the irinotecan plus cisplatin group ) .
CONCLUSIONS	Four cycles of etoposide plus cisplatin and AHTRT should continue to be the standard of care for limited-stage SCLC .
BACKGROUND	National Cancer Center and the Ministry of Health , Labour , and Welfare of Japan .

###24948345
OBJECTIVE	To compare the response with synthetic human parathyroid hormone ( PTH ) 1-34 delivered by twice-daily injection vs insulin pump in children with severe congenital hypoparathyroidism due to calcium receptor mutation or autoimmune polyglandular syndrome type 1 .
METHODS	Children and young adults aged 7-20 years with congenital hypoparathyroidism ( N = 12 ) were randomized to receive PTH 1-34 , delivered either by twice-daily subcutaneous injection or insulin pump for 13 weeks , followed by crossover to the opposite delivery method .
METHODS	The principal outcome measures were serum and urine calcium levels .
METHODS	Secondary outcomes included serum and urine magnesium and phosphate levels and bone turnover markers .
RESULTS	PTH 1-34 delivered via pump produced near normalization of mean serum calcium ( 2.02 0.05 [ pump ] vs 1.88 0.03 [ injection ] mmol/L , P < .05 , normal 2.05-2 .5 mmol/L ) , normalized mean urine calcium excretion ( 5.17 1.10 [ pump ] vs 6.67 0.76 mmol/24 h/1 .73 m ( 2 ) , P = .3 ) , and significantly reduced markers of bone turnover ( P < .02 ) .
RESULTS	Serum and urine calcium and magnesium showed a biphasic pattern during twice-daily injection vs minimal fluctuation during pump delivery .
RESULTS	The PTH 1-34 dosage was markedly reduced during pump delivery ( 0.32 0.04 vs 0.85 0.11 g/kg/d , P < .001 ) , and magnesium supplements were also reduced ( P < .001 ) .
CONCLUSIONS	Compared with twice-daily delivery , pump delivery of PTH 1-34 provides more physiologic calcium homeostasis and bone turnover in children with severe congenital hypoparathyroidism .

###25756419
OBJECTIVE	Whole-body ischemia during out-of-hospital cardiac arrest triggers immediate activation of inflammatory systems leading to a sepsis-like syndrome .
OBJECTIVE	The aim was to investigate the association between level of systemic inflammation and mortality in survivors after out-of-hospital cardiac arrest treated with targeted temperature management .
METHODS	Post hoc analysis .
METHODS	Single-center study of a prospective multicenter randomized study .
METHODS	One hundred sixty-nine patients ( 99 % ) with available blood samples out of 171 patients included in the Target Temperature Management trial , randomly assigning patients to targeted temperature management at 33C or 36C .
METHODS	None .
RESULTS	At baseline and 24 , 48 , and 72 hours after out-of-hospital cardiac arrest , blood samples were obtained and screened for a battery of inflammatory markers .
RESULTS	Level of interleukin-1 , interleukin-2 , interleukin-4 , interleukin-5 , interleukin-6 , interleukin-9 , interleukin-10 , interleukin-12 , interleukin-13 , tumor necrosis factor - , interferon - , C-reactive protein , and procalcitonin were measured .
RESULTS	Mortality at 30 days was evaluated by Cox analysis , and the predictive capability of inflammatory markers was evaluated by area under the curve .
RESULTS	Level of all inflammatory markers changed significantly within 72 hours after out-of-hospital cardiac arrest ( all p values < 0.001 ) , but only procalcitonin levels showed overall differences between nonsurvivors and survivors ( p = 0.0002 ) .
RESULTS	At baseline , interleukin-6 was independently associated with mortality , whereas both interleukin-6 levels ( hazard ratio = 1.23 [ 1.01-1 .49 ] ; p = 0.04 ) and procalcitonin levels ( hazard ratio = 1.20 [ 1.03-1 .39 ] ; p = 0.02 ) 24 hours after out-of-hospital cardiac arrest were associated with 30-day mortality with no interactions between targeted temperature management group and levels of interleukin-6 ( p = 0.25 ) or procalcitonin ( p = 0.85 ) .
RESULTS	None of the other inflammatory markers were independently associated with mortality .
RESULTS	Area under the curve for procalcitonin and interleukin-6 , 24 hours after out-of-hospital cardiac arrest , were 0.74 and 0.63 , respectively .
CONCLUSIONS	Level of inflammation , assessed by interleukin-6 and procalcitonin , was independently associated with increased mortality with the highest discriminative value obtained 24 hours after out-of-hospital cardiac arrest .
CONCLUSIONS	Interventions aiming at decreasing level of inflammation as a way to improve outcome may be investigated in future studies .

###24981955
OBJECTIVE	Candida spp .
OBJECTIVE	are frequently recovered from endotracheal secretions in critically ill patients suspected of having ventilator-associated pneumonia .
OBJECTIVE	Observational studies reported an association with worse clinical outcomes but the effect of antifungal therapy in these patients remains unclear .
OBJECTIVE	We designed this pilot study to assess the feasibility of a larger trial and to evaluate inflammatory profiles and clinical outcomes in these patients .
METHODS	We conducted a double-blind , placebo-controlled , multicenter pilot randomized trial of antifungal therapy in critically ill patients with a clinical suspicion of ventilator-associated pneumonia with positive airway secretion specimens for Candida spp .
METHODS	We also included an observational group without Candida spp .
METHODS	in their airway secretions .
METHODS	We measured recruitment rate , inflammatory and innate immune function profiles over time , and clinical outcomes .
RESULTS	We recruited 60 patients into the randomized trial and 29 patients into the observational study .
RESULTS	Markers of inflammation and all clinical outcomes were comparable between placebo and antifungal treatment group at baseline and over time .
RESULTS	At baseline , plasma TNF - levels were higher in patients with VAP and Candida compared to the observational group ( mean SD ) ( 21.8 23.1 versus 12.4 9.3 pg/ml , p = 0.02 ) and these patients had lower innate immune function as evidenced by reduced whole blood ex vivo LPS-induced TNF - production capacity ( 854.8 855.2 versus 1,559.4 1,290.6 pg/ml , p = 0.01 ) .
CONCLUSIONS	This study does not provide evidence to support a larger trial examining the efficacy of empiric antifungal treatment in patients with a clinical suspicion of ventilator-associated pneumonia and Candida in the endotracheal secretions .
CONCLUSIONS	The presence of Candida in the lung may be associated with persistent inflammation and immunosuppression .

###25425736
BACKGROUND	The purpose of the current study was to investigate whether an informative Web site is effective at producing higher scores for an individual 's knowledge of Alzheimer 's disease ( AD ) relative to those who do not visit a Web site .
METHODS	A total of 552 participants completed the study on Amazon 's Mechanical Turk ; half were randomly assigned to visit alz.org , while a control group did not .
METHODS	Both groups were given the AD Knowledge Scale ( ADKS ) to assess their knowledge of AD .
RESULTS	Participants who visited alz.org scored significantly higher on the ADKS than those in the control group .
RESULTS	Participants who were health care workers demonstrated higher scores than others in the experimental condition .
RESULTS	Findings indicate that the Alzheimer 's Association Web site is effective at producing higher scores for AD knowledge relative to no Web site at all and that it is especially helpful for health care workers compared to those who are not health care workers .

###24998546
BACKGROUND	This study aimed to examine the relationship between respiratory health of Malaysian adolescents with secondhand smoke ( SHS ) exposure and smoke-free legislation ( SFL ) implementation .
METHODS	A total of 898 students from 21 schools across comprehensive - and partial-SFL states were recruited .
METHODS	SHS exposures and respiratory symptoms were assessed via questionnaire .
METHODS	Prenatal and postnatal SHS exposure information was obtained from parental-completed questionnaire .
RESULTS	The prevalence of respiratory symptoms was : 11.9 % ever wheeze , 5.6 % current wheeze , 22.3 % exercise-induced wheeze , 12.4 % nocturnal cough , and 13.1 % self-reported asthma .
RESULTS	SHS exposure was most frequently reported in restaurants .
RESULTS	Hierarchical logistic regression indicates living in a comprehensive-SFL state was not associated with a lower risk of reporting asthma symptoms .
RESULTS	SHS exposure in public transport was linked to increased risk for wheeze ( Adjusted Odds Ratio ( AOR ) 16.6 ; 95 % confidence interval ( CI ) , 2.69-101 .7 ) and current wheezing ( AOR 24.6 ; 95 % CI , 3.53-171 .8 ) .
CONCLUSIONS	Adolescents continue to be exposed to SHS in a range of public venues in both comprehensive - and partial-SFL states .
CONCLUSIONS	Respiratory symptoms are common among those reporting SHS exposure on public transportation .
CONCLUSIONS	Non-compliance with SFL appears to be frequent in many venues across Malaysia and enforcement should be given priority in order to reduce exposure .

###24274836
BACKGROUND	The management of psychiatric inpatients exhibiting severely disturbed and aggressive behaviour is an important educational topic .
BACKGROUND	Well structured , IT-based educational programmes ( eLearning ) often ensure quality and may make training more affordable and accessible .
OBJECTIVE	The aim of this study was to explore the impact of an eLearning course for personnel on the rates and duration of seclusion and mechanical restraint among psychiatric inpatients .
METHODS	In a cluster-randomized intervention trial , the nursing personnel on 10 wards were randomly assigned to eLearning ( intervention ) or training-as-usual ( control ) groups .
METHODS	The eLearning course comprised six modules with specific topics ( legal and ethical issues , behaviour-related factors , therapeutic relationship and self-awareness , teamwork and integrating knowledge with practice ) and specific learning methods .
METHODS	The rates ( incidents per 1000 occupied bed days ) and durations of the coercion incidents were examined before and after the course .
RESULTS	A total of 1283 coercion incidents ( 1143 seclusions [ 89 % ] and 140 incidents involving the use of mechanical restraints [ 11 % ] ) were recorded on the study wards during the data collection period .
RESULTS	On the intervention wards , there were no statistically significant changes in the rates of seclusion and mechanical restraint .
RESULTS	However , the duration of incidents involving mechanical restraints shortened from 36.0 to 4.0 h ( median ) ( P < 0.001 ) .
RESULTS	No statistically significant changes occurred on the control wards .
CONCLUSIONS	After our eLearning course , the duration of incidents involving the use of mechanical restraints decreased .
CONCLUSIONS	However , more studies are needed to ensure that the content of the course focuses on the most important factors associated with the seclusion-related elements .
CONCLUSIONS	The eLearning course deserves further development and further studies .
CONCLUSIONS	The duration of coercion incidents merits attention in future research .

###24796766
OBJECTIVE	To evaluate whether pretreatment dehydroepiandrosterone ( DHEA ) supplementation improves ovarian response markers , ovarian response to standard low-dose gonadotropin stimulation , and in vitro fertilization ( IVF ) outcomes in poor responders .
METHODS	Randomized , double-blind , placebo-controlled pilot study .
METHODS	Tertiary reproductive medicine unit .
METHODS	Thirty-two women with anticipated poor ovarian response .
METHODS	Randomization into DHEA group ( n = 16 ) receiving GNC ( 25 mg three times a day ) or placebo ( n = 16 ) starting from at least 12 weeks before the scheduled IVF treatment according to a computer-generated randomization list .
METHODS	Measurement of monthly ovarian response markers , including antral follicle count ( AFC ) , serum antimllerian hormone ( AMH ) , and follicle-stimulating hormone ( FSH ) levels ; comparison of ovarian response to a standard dose of gonadotropin stimulation at week 8 and IVF outcomes ; and AFC after 12 weeks ( primary outcome ) .
RESULTS	The DHEA supplementation resulted in statistically significantly higher serum DHEA-S , free androgen index , and follicular DHEA-S levels .
RESULTS	No statistically significant differences in the ovarian response markers ( AFC , AMH , or FSH ) , the ovarian response to standard-dose gonadotropin stimulation , or IVF outcomes were found between the two groups .
CONCLUSIONS	No statistically significant improvement in ovarian response markers , ovarian response to standard dose gonadotropin stimulation , or IVF outcomes was found in poor responders receiving pretreatment DHEA .
BACKGROUND	HKCTR-1149 ( www.hkclinicaltrials.com ) and NCT01915186 ( www.ClinicalTrials.org ) .

###24268677
OBJECTIVE	To examine the effect of supplementation with probiotics on respiratory and gastrointestinal illness in healthy active men and women .
METHODS	A randomised double-blind placebo-controlled trial was conducted .
METHODS	Four hundred and sixty five participants ( 241 males ; age 35 12 y ( mean SD ) and 224 females ; age 36 12 y ) were assigned to one of three groups : Group 1 - Bifidobacterium animalis subsp .
METHODS	lactis Bl-04 ( Bl-04 ) 2.0 10 ( 9 ) colony forming units per day , CFU per day , Group 2 - Lactobacillus acidophilus NCFM and Bifidobacterium animalis subsp .
METHODS	lactis Bi-07 ( NCFM & Bi-07 ) 5 10 ( 9 ) CFU each per day ) or Group 3 - placebo mixed in a drink .
RESULTS	The risk of an upper respiratory illness episode was significantly lower in the Bl-04 group ( hazard ratio 0.73 ; 95 % confidence interval 0.55-0 .95 ; P = 0.022 ) compared to placebo .
RESULTS	There was no significant difference in illness risk between the NCFM & Bi-07 group ( hazard ratio 0.81 ; 0.62-1 .08 ; P = 0.15 ) and the placebo group .
RESULTS	There was a 0.7 and 0.9 month delay in the median time to an illness episode in the Bl-04 and NCFM & Bi-07 groups respectively compared to placebo ( placebo 2.5 months ; Bl-04 3.2 months ; NCFM & Bi-07 3.4 months ) .
RESULTS	There were insufficient GI illness episodes for analysis .
RESULTS	The NCFM & Bi-07 group but not the Bl-04 group undertook significantly more physical activity ( 8.5 % ; 6.7 % -10 % ; P < 0.003 ) than the placebo group .
CONCLUSIONS	The probiotic Bl-04 appears to be a useful nutritional supplement in reducing the risk of URTI in healthy physically-active adults .
BACKGROUND	Australia New Zealand Clinical Trials Registry : Number ACTRN12611000130965 .

###24925094
BACKGROUND	Hot flushes and night sweats ( vasomotor symptoms ) are common menopausal symptoms , often causing distress , sleep deprivation and reduced quality of life .
BACKGROUND	Although hormone replacement therapy is an effective treatment , there are concerns about serious adverse events .
BACKGROUND	Non-hormonal pharmacological therapies are less effective and can also cause adverse effects .
BACKGROUND	Complementary therapies , including acupuncture , are commonly used for menopausal vasomotor symptoms .
BACKGROUND	While the evidence for the effectiveness of acupuncture in treating vasomotor symptoms is inconclusive , acupuncture has a low risk of adverse effects , and two small studies suggest it may be more effective than non-insertive sham acupuncture .
BACKGROUND	Our objective is to assess the efficacy of needle acupuncture in improving hot flush severity and frequency in menopausal women .
BACKGROUND	Our current study design is informed by methods tested in a pilot study .
METHODS	This is a stratified , parallel , randomised sham-controlled trial with equal allocation of participants to two trial groups .
METHODS	We are recruiting 360 menopausal women experiencing a minimum average of seven moderate hot flushes a day over a seven-day period and who meet diagnostic criteria for the Traditional Chinese Medicine diagnosis of Kidney Yin deficiency .
METHODS	Exclusion criteria include breast cancer , surgical menopause , and current hormone replacement therapy use .
METHODS	Eligible women are randomised to receive either true needle acupuncture or sham acupuncture with non-insertive ( blunt ) needles for ten treatments over eight weeks .
METHODS	Participants are blinded to treatment allocation .
METHODS	Interventions are provided by Chinese medicine acupuncturists who have received specific training on trial procedures .
METHODS	The primary outcome measure is hot flush score , assessed using the validated Hot Flush Diary .
METHODS	Secondary outcome measures include health-related quality of life , anxiety and depression symptoms , credibility of the sham treatment , expectancy and beliefs about acupuncture , and adverse events .
METHODS	Participants will be analysed in the groups in which they were randomised using an intention-to-treat analysis strategy .
CONCLUSIONS	Results from this trial will significantly add to the current body of evidence on the role of acupuncture for vasomotor symptoms .
CONCLUSIONS	If found to be effective and safe , acupuncture will be a valuable additional treatment option for women who experience menopausal vasomotor symptoms .
BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12611000393954 11/02/2009 .

###24383496
BACKGROUND	Insertion of a ventriculoperitoneal shunt ( VPS ) for the treatment of hydrocephalus is one of the most common neurosurgical procedures in the UK , but failures caused by infection occur in approximately 8 % of primary cases .
BACKGROUND	VPS infection is associated with considerable morbidity and mortality and its management results in substantial cost to the health service .
BACKGROUND	Antibiotic-impregnated ( rifampicin and clindamycin ) and silver-impregnated VPS have been developed to reduce infection rates .
BACKGROUND	Whilst there is some evidence showing that such devices may lead to a reduction in VPS infection , there are no randomised controlled trials ( RCTs ) to support their routine use .
METHODS	Overall , 1,200 patients will be recruited from 17 regional neurosurgical units in the UK and Ireland .
METHODS	Patients of any age undergoing insertion of their first VPS are eligible .
METHODS	Patients with previous indwelling VPS , active and on-going cerebrospinal fluid ( CSF ) or peritoneal infection , multiloculated hydrocephalus requiring multiple VPS or neuroendoscopy , and ventriculoatrial or ventriculopleural shunt planned will be excluded .
METHODS	Patients will be randomised 1:1:1 to either standard silicone ( comparator ) , antibiotic-impregnated , or silver-impregnated VPS .
METHODS	The primary outcome measure is time to VPS infection .
METHODS	Secondary outcome measures include time to VPS failure of any cause , reason for VPS failure ( infection , mechanical failure , or patient failure ) , types of bacterial VPS infection ( organism type and antibiotic resistance ) , and incremental cost per VPS failure averted .
CONCLUSIONS	The British antibiotic and silver-impregnated catheters for ventriculoperitoneal shunts multi-centre randomised controlled trial ( the BASICS trial ) is the first multi-centre RCT designed to determine whether antibiotic or silver-impregnated VPS reduce early shunt infection compared to standard silicone VPS .
CONCLUSIONS	The results of this study will be used to inform current neurosurgical practice and may potentially benefit patients undergoing shunt surgery in the future .
BACKGROUND	International Standard Randomised Controlled Trial Number : ISRCTN49474281 .

###24903230
OBJECTIVE	To study the effect of inspiration on airway dimensions measured in voluntary inspiration breath-hold examinations .
METHODS	961 subjects with normal spirometry were selected from the Danish Lung Cancer Screening Trial .
METHODS	Subjects were examined annually for five years with low-dose CT. .
METHODS	Automated software was utilized to segment lungs and airways , identify segmental bronchi , and match airway branches in all images of the same subject .
METHODS	Inspiration level was defined as segmented total lung volume ( TLV ) divided by predicted total lung capacity ( pTLC ) .
METHODS	Mixed-effects models were used to predict relative change in lumen diameter ( ALD ) and wall thickness ( AWT ) in airways of generation 0 ( trachea ) to 7 and segmental bronchi ( R1-R10 and L1-L10 ) from relative changes in inspiration level .
RESULTS	Relative changes in ALD were related to relative changes in TLV/pTLC , and this distensibility increased with generation ( p < 0.001 ) .
RESULTS	Relative changes in AWT were inversely related to relative changes in TLV/pTLC in generation 3 -- 7 ( p < 0.001 ) .
RESULTS	Segmental bronchi were widely dispersed in terms of ALD ( 5.70.7 mm ) , AWT ( 0.860.07 mm ) , and distensibility ( 23.57.7 % ) .
CONCLUSIONS	Subjects who inspire more deeply prior to imaging have larger ALD and smaller AWT .
CONCLUSIONS	This effect is more pronounced in higher-generation airways .
CONCLUSIONS	Therefore , adjustment of inspiration level is necessary to accurately assess airway dimensions .
CONCLUSIONS	Airway lumen diameter increases and wall thickness decreases with inspiration .
CONCLUSIONS	The effect of inspiration is greater in higher-generation ( more peripheral ) airways .
CONCLUSIONS	Airways of generation 5 and beyond are as distensible as lung parenchyma .
CONCLUSIONS	Airway dimensions measured from CT should be adjusted for inspiration level .

###25586295
OBJECTIVE	Clopidogrel is indicated for the treatment and prevention of peripheral vascular , cerebrovascular , and coronary artery diseases .
OBJECTIVE	This clinical trial was designed to demonstrate that clopidogrel napadisilate ( CN ) is not inferior to clopidogrel bisulfate ( CB ) with respect to its effectiveness in inhibiting platelet aggregation .
METHODS	This 4 week multi-center , prospective , open-label , randomized trial was conducted at five clinical centers in South Korea .
METHODS	Patients were randomized into the 75 mg CN group or the 75mg CB group .
METHODS	Platelet aggregation was assessed by the VerifyNow assay .
METHODS	The primary outcome was the difference of the percentage P2Y12 inhibition and the secondary outcome was the baseline and change in P2Y12 reaction units ( PRU ) .
RESULTS	There was no significant difference in the percentage P2Y12 inhibition ( CN vs. CB , 34.92 21.33 % vs. 30.43 17.90 % , p = 0.203 ) .
RESULTS	The mean difference of the percentage P2Y12 inhibition between groups was 4.49 % , their two-sided 95 % confidence interval was -2.45 % to 11.44 % , and the lower bound ( -2.45 % ) was greater than the acceptable non-inferiority margin of -9.0 % .
RESULTS	The baseline PRU was 96.67 76.76 in the CN group and 216.95 68.86 in the CB group ( p = 0.121 ) , and the change in the PRU was -3.32 51.71 in the CN group and 10.52 43.31 in the CB group ( p = 0.106 ) .
RESULTS	Four subjects experienced AEs ( 6.3 % , 5 events ) in the CN group and 7 subjects ( 11.11 % , 13 events ) in the CB group without statistical significance ( p = 0.364 ) .
RESULTS	With respect to serious adverse events , 2 events were reported in 2 subjects , 1 in each group .
CONCLUSIONS	Clopidogrel napadisilate was not inferior to clopidogrel bisulfate in terms of antiplatelet efficacy and tolerability , and there were no clinically significant adverse events .

###25234932
BACKGROUND	Pharmacists may improve medication-related outcomes during transitions of care .
BACKGROUND	The aim of the Iowa Continuity of Care Study was to determine if a pharmacist case manager ( PCM ) providing a faxed discharge medication care plan from a tertiary care institution to primary care could improve medication appropriateness and reduce adverse events , rehospitalization and emergency department visits .
METHODS	Design .
METHODS	Randomized , controlled trial of 945 participants assigned to enhanced , minimal and usual care groups conducted 2007 to 2012 .
METHODS	Subjects .
METHODS	Participants with cardiovascular-related conditions and/or asthma or chronic obstructive pulmonary disease were recruited from the University of Iowa Hospital and Clinics following admission to general medicine , family medicine , cardiology or orthopedics .
METHODS	Intervention .
METHODS	The minimal group received admission history , medication reconciliation , patient education , discharge medication list and medication recommendations to inpatient team .
METHODS	The enhanced group also received a faxed medication care plan to their community physician and pharmacy and telephone call 3-5 days post-discharge .
METHODS	Participants were followed for 90 days post-discharge .
METHODS	Main Outcomes and Measures .
METHODS	Medication appropriateness index ( MAI ) , adverse events , adverse drug events and post-discharge healthcare utilization were compared by study group using linear and logistic regression , as models accommodating random effects due to pharmacists indicated little clustering .
RESULTS	Study groups were similar at baseline and the intervention fidelity was high .
RESULTS	There were no statistically significant differences by study group in medication appropriateness , adverse events or adverse drug events at discharge , 30-day and 90-day post-discharge .
RESULTS	The average MAI per medication as 0.53 at discharge and increased to 0.75 at 90 days , and this was true across all study groups .
RESULTS	Post-discharge , about 16 % of all participants experienced an adverse event , and this did not differ by study group ( p > 0.05 ) .
RESULTS	Almost one-third of all participants had any type of healthcare utilization within 30 days post-discharge , where 15 % of all participants had a 30-day readmission .
RESULTS	Healthcare utilization post-discharge was not statistically significant different at 30 or 90 days by study group .
CONCLUSIONS	The pharmacist case manager did not affect medication use outcomes post-discharge perhaps because quality of care measures were high in all study groups .
BACKGROUND	Clinicaltrials.gov registration : NCT00513903 , August 7 , 2007 .

###24447425
BACKGROUND	Pegloticase is approved in the US for treatment of refractory chronic gout .
BACKGROUND	Since chronic kidney disease ( CKD ) is common in these patients , we conducted a post-hoc analysis of 2 replicate phase 3 trials and the subsequent open-label extension study to determine the effects of pegloticase on renal function in patients with CKD stages 3 and 4 , as well as the effects of renal dysfunction on pegloticase efficacy and safety .
RESULTS	Patients with renal insufficiency were randomized to pegloticase 8mg every 2 weeks ( n = 42 ) , pegloticase 8mg every 4 weeks ( n = 41 ) , or placebo ( n = 20 ) for 6 months as defined by the study protocols .
RESULTS	Renal function was assessed by estimated glomerular filtration rate ( eGFR ) .
RESULTS	All patients completing the randomized trials could participate in an open-label extension study for a further 2.5 years .
RESULTS	Uric acid response , the primary end point in the trials , was plasma uric acid < 6.0 mg/dl for 80 % of months 3 and 6 .
RESULTS	Mean eGFR in both pegloticase dosing cohorts remained constant over the randomized treatment phase and long-term open-label extension study .
RESULTS	The number of patients achieving uric acid response was similar across CKD stages ( 32 % stage 1 , 23 % stage 2 , 35 % stage 3 , and 39 % stage 4 , respectively , P = 0.3 ) .
RESULTS	There was no difference in the pegloticase safety profile based on CKD stage .
CONCLUSIONS	Pegloticase treatment does not impact eGFR in CKD patients and response to pegloticase is independent of CKD stage .
BACKGROUND	Clinical trial identifier : NCT00325195 .

###24421213
OBJECTIVE	The effect of positive vs. negative comments ( praise vs. criticism ) on trainees ' subsequent cognitive and technical performance is unknown , but of potential importance .
OBJECTIVE	We performed a randomized trial of giving either praise or criticism during simulated normal vaginal deliveries ( using a high-fidelity birthing simulator ) to assess the differential effect of these types of comments on students ' cognitive and technical performance , and perceived confidence after their learning experience .
METHODS	Medical and nursing students underwent stratified randomization to praise or criticism .
METHODS	Students ( n = 59 ) initially participated in a teaching demonstration and practiced normal spontaneous vaginal delivery using a birthing simulator .
METHODS	A baseline assessment of cognitive and technical skills , and of self-confidence , was followed by a second simulation during which positive or negative comments were given using standardized scripts .
METHODS	Cognitive performance , technical performance and confidence measures were then scored again .
RESULTS	Cognitive and technical performance scores in the `` praise '' group improved significantly by 2.5 ( P = 0.007 ) and 1.8 ( P = 0.032 ) , respectively , while those in the `` criticism '' group remained unchanged .
RESULTS	The self-reported confidence scores did not show any significant change from baseline in either group .
CONCLUSIONS	Praise strengthens students ' cognitive and technical performances , while criticism does not .

###25151225
BACKGROUND	Intradermal MVA85A , a candidate vaccine against tuberculosis , induces high amounts of Ag85A-specific CD4 T cells in adults who have already received the BCG vaccine , but aerosol delivery of this vaccine might offer immunological and logistical advantages .
BACKGROUND	We did a phase 1 double-blind trial to compare the safety and immunogenicity of aerosol-administered and intradermally administered MVA85A METHODS : In this phase 1 , double-blind , proof-of-concept trial , 24 eligible BCG-vaccinated healthy UK adults were randomly allocated ( 1:1 ) by sequentially numbered , sealed , opaque envelopes into two groups : aerosol MVA85A and intradermal saline placebo or intradermal MVA85A and aerosol saline placebo .
BACKGROUND	Participants , the bronchoscopist , and immunologists were masked to treatment assignment .
BACKGROUND	The primary outcome was safety , assessed by the frequency and severity of vaccine-related local and systemic adverse events .
BACKGROUND	The secondary outcome was immunogenicity assessed with laboratory markers of cell-mediated immunity in blood and bronchoalveolar lavage samples .
BACKGROUND	Safety and immunogenicity were assessed for 24 weeks after vaccination .
BACKGROUND	Immunogenicity to both insert Ag85A and vector modified vaccinia virus Ankara ( MVA ) was assessed by ex-vivo interferon - ELISpot and serum ELISAs .
BACKGROUND	Since all participants were randomised and vaccinated according to protocol , our analyses were per protocol .
BACKGROUND	This trial is registered with ClinicalTrials.gov , number NCT01497769 .
RESULTS	Both administration routes were well tolerated and immunogenic .
RESULTS	Respiratory adverse events were rare and mild .
RESULTS	Intradermal MVA85A was associated with expected mild local injection-site reactions .
RESULTS	Systemic adverse events did not differ significantly between the two groups .
RESULTS	Three participants in each group had no vaccine-related systemic adverse events ; fatigue ( 11/24 [ 46 % ] ) and headache ( 10/24 [ 42 % ] ) were the most frequently reported symptoms .
RESULTS	Ag85A-specific systemic responses were similar across groups .
RESULTS	Ag85A-specific CD4 T cells were detected in bronchoalveolar lavage cells from both groups and responses were higher in the aerosol group than in the intradermal group .
RESULTS	MVA-specific cellular responses were detected in both groups , whereas serum antibodies to MVA were only detectable after intradermal administration of the vaccine .
CONCLUSIONS	Further clinical trials assessing the aerosol route of vaccine delivery are merited for tuberculosis and other respiratory pathogens .
BACKGROUND	The Wellcome Trust and Oxford Radcliffe Hospitals Biomedical Research Centre .

###25011952
OBJECTIVE	We recently demonstrated a beneficial effect of metformin compared with glipizide in type 2 diabetic patients regarding cardiovascular outcomes for 3-year treatment in the SPREAD-DIMCAD study .
OBJECTIVE	However , the potential mechanism for the clinical effects remains unclear .
OBJECTIVE	Here , we performed a comprehensive lipidomics study to evaluate the different lipid metabolites in serum samples obtained from participants in this study .
METHODS	Liquid chromatography-quadrupole time of flight-mass spectrometry was used to evaluate the different lipid metabolites in serum samples obtained from the participants ( 21 patients in glipizide group and 23 patients in metformin group ) before and after each year of treatment ( at 0 [ baseline ] , 1 , 2 , and 3 years of study drug administration ) .
RESULTS	A total of 118 serum lipid molecular species was identified and quantified .
RESULTS	During treatment , metformin induced a substantially greater change in serum lipid species compared with glipizide , especially at the 2 - and 3-year time points ( with 2 , 11 , and 12 lipid species being significantly different between the groups after each year of treatment [ 1 , 2 , or 3 years ] , P < 0.05 ) .
RESULTS	Among the significantly changed lipid species , three lipid metabolites were linked to long-term composite cardiovascular events ( adjusted P < 0.05 ) .
RESULTS	After treatment , triacylglycerols ( TAGs ) of a relatively higher carbon number showed a clearly increased trend in metformin group compared with the glipizide group , whereas the changes in TAGs with different double bonds were minimal .
CONCLUSIONS	Our findings revealed the differential therapeutic effects of metformin and glipizide on comprehensive lipidomics , which were comparable with their different long-term effects on cardiovascular outcomes .

###25594912
BACKGROUND	Proprioception is essential to motor control and joint stability during daily and sport activities .
BACKGROUND	Recent studies demonstrated that athletes have better joint position sense ( JPS ) when compared with controls matched for age , suggesting that physical training could have an effect on proprioception .
OBJECTIVE	To evaluate the result of an 8-week strength-training program on shoulder JPS and to verify whether using training intensities that are the same or divergent for the shoulder 's dynamic-stabilizer muscles promote different effects on JPS .
METHODS	Randomized controlled clinical trial .
METHODS	We evaluated JPS in a research laboratory and conducted training in a gymnasium .
METHODS	A total of 90 men , right handed and asymptomatic , with no history of any type of injury or shoulder instability .
METHODS	For 8 weeks , the participants performed the strength-training program 3 sessions per week .
METHODS	We used 4 exercises ( bench press , lat pull down , shoulder press , and seated row ) , with 2 sets each .
METHODS	We measured shoulder JPS acuity by calculating the absolute error .
RESULTS	We found an interaction between group and time .
RESULTS	To examine the interaction , we conducted two 1-way analyses of variance comparing groups at each time .
RESULTS	The groups did not differ at pretraining ; however , a difference among groups was noted posttraining .
CONCLUSIONS	Strength training using exercises at the same intensity produced an improvement in JPS compared with exercises of varying intensity , suggesting that the former resulted in improvements in the sensitivity of muscle spindles and , hence , better neuromuscular control in the shoulder .

###25321620
OBJECTIVE	Covered nitinol alloy self-expandable metal stents ( SEMSs ) have been developed to overcome the shortcomings of steel SEMS in patients with malignant biliary obstruction .
OBJECTIVE	In a randomized , multicenter trial , we compared stent patency , patient survival , and adverse events in patients with partly covered stents made from steel or nitinol .
METHODS	A total of 400 patients with unresectable distal malignant biliary obstruction were randomized at endoscopic retrograde cholangiopancreatography ( ERCP ) to insertion of a steel or nitinol partially covered SEMS , with 200 patients in each group.The primary outcome was confirmed stent failure during 300 days of follow-up .
RESULTS	At 300 days , the proportion of patients with patent stents was 77 % in the steel group , compared with 89 % in the nitinol group ( P = 0.01 ) .
RESULTS	Confirmed stent failure occurred more often in the steel SEMS group compared with the nitinol SEMS group , in 30 versus 14 patients ( P = 0.02 ) .
RESULTS	Stent migration occurred in 13 patients in the steel group and in 3 patients in the nitinol group ( P = 0.01 ) .
RESULTS	Median patient survival ( secondary outcome ) was 137 days and 120 days in the steel SEMS and nitinol SEMS groups , respectively ( P = 0.59 ) .
CONCLUSIONS	The nitinol SEMS showed longer patency time , and the nitinol group had fewer patients with stent failure , compared with the steel SEMS group .
CONCLUSIONS	We could not detect any differences between the two groups regarding survival time , and regarding adverse event rate.Clinical trial registration : NCT 00980889 .

###24343071
OBJECTIVE	To evaluate the combined effect of premedication of parecoxib sodium and local infiltration of ropivocaine on postoperative shoulder pain and incisional pain in patients undergoing diagnostic hysteroscopy and laparoscopy .
METHODS	In the study , 60 patients undergoing elective diagnostic hysteroscopy and laparoscopy were randomly allocated to two groups ( each with 30 patients ) .
METHODS	The patients in group 1 were premedicated with 40 mg parecoxib sodium ( diluted with 2 mL normal saline ) , and 0.5 % ropivacaine ( 20 mL ) were infiltrated around the incision site before establishment of CO2 pneumoperitoneum .
METHODS	The patients in group 2 received 2 mL normal saline intraveniously before anesthesia induction , and infiltration of 0.5 % ropivacaine 20 mL were also applied as group 1 .
METHODS	After anesthetic withdrawal , the patients ' postoperative anesthesia recovery time and the time point of opening eyes on verbal command were noted .
METHODS	The intensities of postoperative shoulder pain and incisional pain were evaluated at 0 , 2 , 4 , 8 , 12 , 24 , and 48 h after surgery .
METHODS	The postoperative analgesic requirement was met by administration of tramadol .
RESULTS	Compared with group 2 , the incidence of postoperative shoulder pain was less in group 1 ( 37 % vs. 67 % , P = 0.020 ) , and the occurence of severe pain was lower ( 4 vs. 11 , P = 0.037 ) .
RESULTS	The numerical rating scales ( NRS ) of right shoulder pain of group 1 were significantly reduced than those of group 2 at 12 h postoperatively [ 0 ( 0 , 2 ) vs. 0 ( 0 , 8 ) , P = 0.012 ] .
RESULTS	Left shoulder pain did not appear at 0 h and 2 h in both groups , while at 12 h and 24 h postoperatively , the NRS scores of group 1 were lower than those of group 2 [ 0 ( 0 , 1 ) vs. 0 ( 0 , 8 ) , P = 0.026 ; 0 ( 0 , 4 ) vs. 2 ( 0 , 9 ) , P = 0.014 ] .
RESULTS	The dynamic and static abdominal pain scores of group 1 were significantly decreased than those of group 2 in post-anesthesia care unit ( PACU ) after surgery ( P = 0.001 , P = 0.005 ) .
RESULTS	The NRS scores of static abdominal pain of group 1 were significantly reduced than those of group 2 at 12 h and 24 h postoperatively ( P = 0.042 , P = 0.029 ) .
RESULTS	More patients in group 2 needed tramadol within 24 h postoperatively ( 8 vs. 0 , P = 0.002 ) .
CONCLUSIONS	Premedication of parecoxib sodium combined with local infiltration of ropinvocaine before incision could significantly reduce the postoperative shoulder pain and incisional pain as well as reduce opioid consumption in patients undergoing diagnostic hysteroscopy and laparoscopy .

###25119950
BACKGROUND	The use of live attenuated varicella vaccine ( Varilrix ( ) ) as an adjuvant treatment in severe cases of psoriasis has recently been postulated .
BACKGROUND	Its efficacy raised questions regarding its possible mechanisms of action .
OBJECTIVE	To compare the efficacy and safety of combining Varilrix ( ) and cyclosporine to cyclosporine alone in the treatment of severe psoriasis .
OBJECTIVE	Furthermore , to study the expression of T helper ( Th ) 17 and T regulatory ( Tregs ) cells before and after therapy .
METHODS	This randomized controlled trial included 24 psoriatic patients , randomly divided into 2 groups ( A and B ) .
METHODS	All patients received cyclosporine at a daily dose of 2.5 mg/kg/day .
METHODS	In addition , group A received 4 doses of Varilrix ( ) once/3 weeks , and group B received 4 doses of subcutaneous saline .
METHODS	Skin biopsies were obtained from all patients before and after therapy and from all controls for estimation of interleukin ( IL ) -17 , IL-22 and Forkhead boxP3 ( FoxP3 ) using RT-PCR .
RESULTS	Group A patients showed a significantly higher % of clinical improvement ( P = 0.011 ) , which occurred earlier than group B.
RESULTS	At baseline , levels of IL-17 and IL-22 were significantly higher while the level of FoxP3 was significantly lower in patients ( P < 0.001 ) compared to controls .
RESULTS	After therapy , both groups showed significant reductions in both IL-17 and IL-22 levels , and significant elevation in FoxP3 ( P < 0.001 ) .
RESULTS	This change was significantly more evident in group A patients .
CONCLUSIONS	Live attenuated varicella vaccine could play a role in the treatment of psoriasis when combined with low dose cyclosporine through accentuating the influence on the Th17/Treg balance .

###24997476
BACKGROUND	Exercise is beneficial for breast cancer patients during chemotherapy but adherence to different types and doses of exercise is a challenge .
BACKGROUND	The purpose of this study was to examine predictors of adherence to different types and doses of exercise during breast cancer chemotherapy in a multicenter randomized controlled trial .
METHODS	Breast cancer patients in Edmonton , Vancouver , and Ottawa , Canada receiving chemotherapy ( N = 301 ) were randomized to a standard dose of 25-30 minutes of aerobic exercise ( STAN ) , a higher dose of 50-60 minutes of aerobic exercise ( HIGH ) , or a higher dose of 50-60 minutes of combined aerobic and resistance exercise ( COMB ) .
METHODS	Predictors included demographic , medical , fitness , and quality of life variables .
METHODS	Exercise adherence was measured as the percentage of supervised exercise sessions completed .
RESULTS	Overall adherence to the supervised exercise sessions was 73 % ( SD = 24 % ) .
RESULTS	In a multivariate regression model , six independent predictors explained 26.4 % ( p < 0.001 ) of the variance in exercise adherence .
RESULTS	Higher exercise adherence was achieved by breast cancer patients in Vancouver ( p < 0.001 ) , with fewer endocrine symptoms ( p = 0.009 ) , randomized to STAN ( p = 0.009 ) , with fewer exercise limitations ( p = 0.009 ) , receiving shorter chemotherapy protocols ( p = 0.015 ) , and with higher VO2peak ( p = 0.017 ) .
RESULTS	Disease stage ( p for interaction = 0.015 ) and body mass index ( p for interaction = 0.030 ) interacted with group assignment to predict adherence .
RESULTS	For disease stage , patients with stage I/IIa disease adhered equally well to all three exercise interventions whereas patients with stage IIb/III disease adhered better to the STAN intervention than the two higher dose exercise interventions .
RESULTS	For body mass index , healthy weight patients adhered equally well to all three exercise interventions whereas overweight patients adhered best to STAN and worst to COMB ; and obese patients adhered best to STAN and worst to HIGH .
CONCLUSIONS	Determinants of exercise adherence in breast cancer patients receiving chemotherapy are multidisciplinary and may vary by the exercise prescription .

###24983989
BACKGROUND	A live oral cholera vaccine VA 1.4 developed from a non-toxigenic Vibrio cholerae O1 El Tor strain using ctxB gene insertion was further developed into a clinical product following cGMP and was evaluated in a double-blind randomized placebo controlled parallel group two arm trial with allocation ratio of 11 for safety and immunogenicity in men and women aged 18-60 years from Kolkata , India .
METHODS	A lyophilized dose of 1.9109 CFU ( n = 44 ) or a placebo ( n = 43 ) reconstituted with a diluent was administered within 5 minutes of drinking 100 ml of a buffer solution made of sodium bicarbonate and ascorbic acid and a second dose on day 14 .
RESULTS	The vaccine did not elicit any diarrhea related adverse events .
RESULTS	Other adverse events were rare , mild and similar in two groups .
RESULTS	One subject in the vaccine group excreted the vaccine strain on the second day after first dose .
RESULTS	The proportion of participants who seroconverted ( i.e. had 4-folds or higher rise in reciprocal titre ) in the vaccine group were 65.9 % ( 95 % CI : 50.1 % -79.5 % ) at both 7 days ( i.e. after 1st dose ) and 21 days ( i.e. after 2nd dose ) .
RESULTS	None of the placebo recipients seroconverted .
RESULTS	Anti-cholera toxin antibody was detected in very few recipients of the vaccine .
CONCLUSIONS	This study demonstrates that VA 1.4 at a single dose of 1.9109 is safe and immunogenic in adults from a cholera endemic region .
CONCLUSIONS	No additional benefit after two doses was seen .
BACKGROUND	Clinical Trials Registry-India , National Institute of Medical Statistics ( Indian Council of Medical Research ) CTRI/2012/04 / 002582 .

###25611313
BACKGROUND	The objective of this study was to evaluate the efficacy of belinostat , a histone deacetylase inhibitor , when added to paclitaxel/carboplatin in the empiric first-line treatment of patients with carcinoma of unknown primary site ( CUP ) .
METHODS	In this randomized phase 2 trial , previously untreated patients with CUP were randomized to receive belinostat plus paclitaxel/carboplatin ( group A ) or paclitaxel/carboplatin alone ( group B ) repeated every 21 days .
METHODS	Patients were re-evaluated every 2 cycles , and those without disease progression continued treatment for 6 cycles .
METHODS	Patients in group A then continued receiving single-agent belinostat , whereas patients in group B stopped treatment .
METHODS	The primary endpoint was progression-free survival ( PFS ) : The authors postulated that the addition of belinostat would improve PFS from 5 months ( expected with paclitaxel/carboplatin ) to 8 months .
RESULTS	In total , 89 patients were randomized ( group A , n = 44 ; group B , n = 45 ) , and the demographics and disease characteristics were balanced between the 2 groups .
RESULTS	The addition of belinostat to paclitaxel/carboplatin did not improve PFS ( group A , 5.4 months [ 95 % confidence interval , 3.0-6 .0 months ] ; group B , 5.3 months [ 95 % confidence interval , 2.8-6 .6 months ] ; P = .85 ) .
RESULTS	Overall survival was 12.4 months for group A versus 9.1 months for group B ( P = .20 ) .
RESULTS	The response rate favored the belinostat group ( 45 % vs 21 % ; P = .02 ) .
RESULTS	Belinostat resulted in a modest increase in treatment toxicity .
CONCLUSIONS	The addition of belinostat to paclitaxel/carboplatin did not improve the PFS of patients with CUP who were receiving first-line therapy , although the patients who received belinostat had a higher investigator-assessed response rate .
CONCLUSIONS	Future trials in CUP should focus on specific subsets , defined either by the predicted tissue of origin or by the identification of targetable molecular abnormalities .

###24321456
BACKGROUND	Epidemiological and toxicological evidence suggests lower risk of smokeless tobacco ( ST ) products compared to cigarettes .
BACKGROUND	Less is known , however , about consumer perceptions and use of novel forms of ST , including snus and dissolvable tobacco .
METHODS	In this study , we conducted in-person experimental auctions in Buffalo , NY , Columbia , SC , and Selinsgrove , PA with 571 smokers to test the impact of information and product trials on smokers ' preferences .
METHODS	Auctions were conducted between November 2010-November 2011 .
RESULTS	We found no evidence of an impact of product trials on demand in our auctions .
RESULTS	Anti-ST information increased demand for cigarettes when presented alone , but when presented with pro-ST information it decreased demand for cigarettes .
RESULTS	It did not decrease demand for ST products .
RESULTS	Anti-smoking information increased demand for ST products , but did not affect cigarette demand .
CONCLUSIONS	These findings suggest that credible and effective communications about tobacco harm reduction should reinforce the negative effects of smoking .

###25195970
OBJECTIVE	To evaluate the proportion of patients achieving clinically meaningful improvement of lower urinary tract symptoms suggestive of benign prostatic hyperplasia ( BPH-LUTS ) with tadalafil using two definitions of response .
METHODS	Post hoc integrated analysis of four placebo-controlled studies in men ( aged 45 years ; International Prostate Symptom Score [ IPSS ] of 13 ; maximum urinary flow rate [ Q ( max ) ] of 4 to 15 mL/s ) with BPH-LUTS randomised to tadalafil 5 mg ( 752 patients ) or placebo ( 747 ) for 12 weeks after a 4-week placebo run-in .
METHODS	Responders were defined as having a total IPSS improvement of 3 points or 25 % from randomisation to endpoint ( Week 12 ) .
METHODS	Response status was calculated per patient , and relative benefit and odds ratio ( OR ) with 95 % confidence interval ( CI ) of tadalafil vs placebo was calculated using a logistic Generalised Mixed Model for Repeated Measures .
RESULTS	Tadalafil 5 mg once daily resulted in a significantly greater proportion of patients achieving a 3-point IPSS improvement ( 71.1 % and 56.0 % for tadalafil and placebo patients , respectively [ OR 1.9 , 95 % CI 1.5 , 2.4 ; P < 0.001 ] ) and achieving a 25 % improvement in total IPSS randomisation to endpoint ( 61.7 % and 45.5 % for tadalafil and placebo patients , respectively [ OR 2.0 , 95 % CI 1.6 , 2.5 ; P < 0.001 ] ) .
CONCLUSIONS	About two-thirds of tadalafil-treated patients achieve a clinically meaningful improvement in BPH-LUTS symptoms , based on two different definitions of responder status .

###25156987
OBJECTIVE	We investigated the longitudinal association of depression , with and without cognitive dysfunction , with hemoglobin A1c ( HbA1c ) , systolic blood pressure ( SBP ) , and low-density lipoprotein ( LDL ) in a predominantly minority cohort .
METHODS	There were 613 participants .
METHODS	Presence of depression was defined by a score 7 on the Short-CARE depression scale .
METHODS	We tested participants for executive dysfunction using the Color Trails Test ( CTT ) , part 2 , and for memory dysfunction using the total recall task of the Selective Reminding Test ( TR-SRT ) .
METHODS	We classified performance in these tests as abnormal based on standardized score cutoffs ( < 16th percentile and one standard deviation below the sample mean ) .
METHODS	Random effects models were used to compare repeated measures of the diabetes control measures between those with depression versus those without depression and ever versus never cognitively impaired .
RESULTS	Baseline depression was present in 36 % of participants .
RESULTS	Over a median follow-up of 2 years , depression was not related to worse HbA1c , SBP , or LDL .
RESULTS	The presence of ( 1 ) abnormal performance on a test of executive function and depression ( n = 57 ) or ( 2 ) abnormal performance on a test of verbal recall and depression ( n = 43 ) was also not associated with clinically significant worse change in diabetes control .
CONCLUSIONS	Depression , with or without low performance in tests of executive function and memory , may not affect clinically significant measures of diabetes control in the elderly .

###25109239
OBJECTIVE	To investigate the long-term safety and maintenance of efficacy of monotherapy with once-daily zonisamide versus twice-daily controlled-release carbamazepine for partial seizures in adults with newly diagnosed epilepsy .
METHODS	Long-term , double-blind , extension study , conducted in patients completing a phase III noninferiority trial comparing zonisamide and carbamazepine monotherapy .
METHODS	Patients continued their randomized treatment , with dosing adjusted according to tolerability/response ( zonisamide 200-500 mg/day ; carbamazepine 400-1 ,200 mg/day ) .
METHODS	Safety assessments included treatment-emergent adverse events ( TEAEs ) and clinical laboratory parameters .
METHODS	Efficacy assessments included retention rate and the proportion of patients remaining seizure free for 24 months .
RESULTS	Overall , 120 ( 87.6 % ) of 137 patients randomized to zonisamide and 134 ( 84.8 % ) of 158 patients randomized to carbamazepine completed the study .
RESULTS	More than three-fourths of patients were exposed to > 24 months of treatment .
RESULTS	For zonisamide versus carbamazepine , incidences were similar for TEAEs ( 52.6 % vs. 46.2 % ) , serious treatment-related TEAEs ( 0.7 % vs. 1.9 % ) , and TEAEs leading to withdrawal ( 1.5 % vs. 0.6 % ) .
RESULTS	The incidence of treatment-related TEAEs was 26.3 % for zonisamide compared with 19.6 % for carbamazepine , and the most frequently reported treatment-related TEAEs were decreased weight ( 5.1 % vs. 0 % ) , decreased appetite ( 3.6 % vs. 0 % ) , memory impairment ( 2.9 % vs. 3.2 % ) , and decreased hemoglobin level ( 1.5 % vs. 3.2 % ) .
RESULTS	Most TEAEs were of mild or moderate intensity .
RESULTS	There were no reports of Stevens-Johnson syndrome or toxic epidermal necrolysis in either group .
RESULTS	Zonisamide was associated with small-to-moderate decreases in bicarbonate levels from baseline ( mean -3.4 mm ) .
RESULTS	There were no reports of metabolic acidosis .
RESULTS	Retention rates were generally similar between treatment groups at all time points throughout the extension study .
RESULTS	The proportion of patients remaining seizure free for 24 months was also similar for zonisamide ( 32.3 % ) and carbamazepine ( 35.2 % ) .
CONCLUSIONS	Once-daily zonisamide monotherapy demonstrated favorable long-term safety and maintenance of efficacy in treating partial seizures in adults with newly diagnosed epilepsy .
CONCLUSIONS	No new or unexpected safety findings emerged .

###24244449
BACKGROUND	Inflammatory response during sepsis is incompletely understood due to small sample sizes and variable timing of measurements following the onset of symptoms .
BACKGROUND	The vasopressin in septic shock trial ( VASST ) compared the addition of vasopressin to norepinephrine alone in patients with septic shock .
BACKGROUND	During this study plasma was collected and 39 cytokines measured in a 363 patients at both baseline ( before treatment ) and 24 hours .
BACKGROUND	Clinical features relating to both underlying health and the acute organ dysfunction induced by the severe infection were collected during the first 28 days of admission .
OBJECTIVE	Cluster analysis of cytokines identifies subgroups of patients at differing risk of death and organ failure .
METHODS	Circulating cytokines and other signaling molecules were measured using a Luminex multi-bead analyte detection system .
METHODS	Hierarchical clustering was performed on plasma values to create patient subgroups .
METHODS	Enrichment analysis identified clinical outcomes significantly different according to these chemically defined patient subgroups .
METHODS	Logistic regression was performed to assess the importance of cytokines for predicting patient subgroups .
RESULTS	Plasma levels at baseline produced three subgroups of patients , while 24 hour levels produced two subgroups .
RESULTS	Using baseline cytokine data , one subgroup of 47 patients showed a high level of enrichment for severe septic shock , coagulopathy , renal failure , and risk of death .
RESULTS	Using data at 24 hours , a larger subgroup of 81 patients that largely encompassed the 47 baseline subgroup patients had a similar enrichment profile .
RESULTS	Measurement of two cytokines , IL2 and CSF2 and their product were sufficient to classify patients into these subgroups that defined clinical risks .
CONCLUSIONS	A distinct pattern of cytokine levels measured early in the course of sepsis predicts disease outcome .
CONCLUSIONS	Subpopulations of patients have differing clinical outcomes that can be predicted accurately from small numbers of cytokines .
CONCLUSIONS	Design of clinical trials and interventions may benefit from consideration of cytokine levels .

###24274210
BACKGROUND	Nasal packing is usually performed to control bleeding after endoscopic sinus surgery ( ESS ) .
BACKGROUND	Although new packing materials have been developed , they still cause pain .
BACKGROUND	This study was designed to evaluate the effect of lidocaine-soaked packs on pain after ESS .
METHODS	A prospective , randomized , double-blind controlled trial was conducted in 63 patients with CRS undergoing ESS .
METHODS	At the conclusion of the operation , 2 % lidocaine-soaked biodegradable synthetic polyurethane foam and saline-soaked polyurethane foam were inserted in both nasal cavities of 31 patients and 32 control patients , respectively .
METHODS	The same lidocaine or saline was reapplied into the nasal packs at postoperative 8 hours .
METHODS	Pain was evaluated using a visual analog scale at postoperative 1 , 4 , 8 , 16 , 20 , and 24 hour ( s ) .
METHODS	The number of gauze that cleaned the blood around the nose was counted .
METHODS	Heart rate , rhythm , and blood pressures were checked preoperatively and postoperatively to evaluate the influence of lidocaine on vital signs .
RESULTS	Postoperative pain decreased in lidocaine group at all of the postoperative time periods ( p < 0.05 ) .
RESULTS	Lidocaine reduced postoperative bleeding at postoperative 8 and 24 hours .
RESULTS	Changes of blood pressure from preoperative values in the lidocaine group were not different from those in the control group ( p > 0.05 ) .
RESULTS	Heart rate in the lidocaine group was more stable than that in the control group ( p < 0.05 ) .
CONCLUSIONS	Lidocaine-soaked packs significantly reduced postoperative pain without serious changes on vital sign .
CONCLUSIONS	These findings suggest that topical lidocaine application to nasal packs could be a useful method to reduce pain during the early postoperative period after ESS .

###24836780
BACKGROUND	The anti-influenza virus activity of green tea catechins has been demonstrated in experimental studies , but clinical evidence has been inconclusive .
BACKGROUND	School-aged children play an important role in the infection and spread of influenza in the form of school-based outbreaks .
BACKGROUND	Preventing influenza infection among students is essential for reducing the frequency of epidemics and pandemics .
BACKGROUND	As a non-pharmaceutical intervention against infection , gargling is also commonly performed in Asian countries but has not yet been extensively studied .
RESULTS	A randomized , open label , 2-group parallel study of 757 high school students ( 15 to 17 years of age ) was conducted for 90 days during the influenza epidemic season from December 1st , 2011 to February 28th , 2012 , in 6 high schools in Shizuoka Prefecture , Japan .
RESULTS	The green tea gargling group gargled 3 times a day with bottled green tea , and the water gargling group did the same with tap water .
RESULTS	The water group was restricted from gargling with green tea .
RESULTS	The primary outcome measure was the incidence of laboratory-confirmed influenza using immunochromatographic assay for antigen detection .
RESULTS	757 participants were enrolled and 747 participants completed the study ( 384 in the green tea group and 363 in the water group ) .
RESULTS	Multivariate logistic regression indicated no significant difference in the incidence of laboratory-confirmed influenza between the green tea group ( 19 participants ; 4.9 % ) and the water group ( 25 participants ; 6.9 % ) ( adjusted OR , 0.69 ; 95 % CI , 0.37 to 1.28 ; P = 0.24 ) .
RESULTS	The main limitation of the study is the adherence rate among high school students was lower than expected .
CONCLUSIONS	Among high school students , gargling with green tea three times a day was not significantly more efficacious than gargling with water for the prevention of influenza infection .
CONCLUSIONS	In order to adequately assess the effectiveness of such gargling , additional large-scale randomized studies are needed .
BACKGROUND	ClinicalTrials.gov NCT01225770 .

###24621976
OBJECTIVE	The purpose of this study is to investigate the effects of urocortin-2 as adjunct therapy in acute decompensated heart failure ( ADHF ) .
BACKGROUND	Urocortin-2 produced favorable integrated effects in experimental heart failure but there are no equivalent human data .
BACKGROUND	We describe the first therapeutic study of urocortin-2 infusion in ADHF .
METHODS	Fifty-three patients with ADHF were randomly assigned to 5 ng/kg/min of urocortin-2 or placebo infusion for 4 h as an adjunct therapy .
METHODS	Changes in vital signs , plasma neurohormonal and renal indices during treatment were compared using repeated-measures analysis of covariance .
METHODS	Ten patients in each arm underwent more detailed invasive hemodynamic evaluation .
RESULTS	Urocortin-2 produced greater falls in systolic blood pressure compared to placebo ( 16 5.8 mm Hg , p < 0.001 ) with nonsignificant increases in heart rate ( 5.7 3.8 beats/min , p = 0.07 ) and increased cardiac output ( 2.1 0.4 l/min vs. -0.1 0.4 l/min , p < 0.001 ) associated with a 47 % reduction in calculated total peripheral resistance ( p = 0.015 ) .
RESULTS	Falls in pulmonary artery and pulmonary capillary wedge pressures did not differ significantly between groups .
RESULTS	Urocortin-2 reduced urine volume and creatinine clearance during infusion but these returned to above baseline level in the 8 h after infusion .
RESULTS	Plasma renin activity rose briefly with urocortin-2 coinciding with reductions in blood pressure ( p < 0.001 ) .
RESULTS	B-type natriuretic peptide levels fell significantly over 24 h with urocortin-2 ( p < 0.01 ) but not with placebo .
CONCLUSIONS	Urocortin-2 infusion in ADHF markedly augmented cardiac output without significant reflex tachycardia .
CONCLUSIONS	Renal indices fell transiently concurrent with urocortin-2-induced reductions in blood pressure .
CONCLUSIONS	Further investigations are required to uncover the full potential of urocortin-2 in treating ADHF .

###25886930
BACKGROUND	Many HIV-infected pregnant women identified during antenatal care ( ANC ) do not enroll in long-term HIV care , resulting in deterioration of maternal health and continued risk of HIV transmission to infants .
METHODS	We performed a cluster randomized trial to evaluate the effect of integrating HIV care into ANC clinics in rural Kenya .
METHODS	Twelve facilities were randomized to provide either integrated services ( ANC , prevention of mother-to-child transmission , and HIV care delivered in the ANC clinic ; n = 6 intervention facilities ) or standard ANC services ( including prevention of mother-to-child transmission and referral to a separate clinic for HIV care ; n = 6 control facilities ) .
RESULTS	There were high patient attrition rates over the course of this study .
RESULTS	Among study participants who enrolled in HIV care , there was 12-month follow-up data for 256 of 611 ( 41.8 % ) women and postpartum data for only 325 of 1172 ( 28 % ) women .
RESULTS	By 9 months of age , 382 of 568 ( 67.3 % ) infants at intervention sites and 338 of 594 ( 57.0 % ) at control sites had tested for HIV [ odds ratio ( OR ) 1.45 , 95 % confidence interval ( CI ) : 0.71 to 2.82 ] ; 7.3 % of infants tested HIV positive at intervention sites compared with 8.0 % of infants at control sites ( OR 0.89 , 95 % CI : 0.56 to 1.43 ) .
RESULTS	The composite clinical/immunologic progression into AIDS was similar in both arms ( 4.9 % vs. 5.1 % , OR 0.83 , 95 % CI : 0.41 to 1.68 ) .
CONCLUSIONS	Despite the provision of integrated services , patient attrition was substantial in both arms , suggesting barriers beyond lack of service integration .
CONCLUSIONS	Integration of HIV services into the ANC clinic was not associated with a reduced risk of HIV transmission to infants and did not appear to affect short-term maternal health outcomes .

###24375296
BACKGROUND	It is still unclear whether D2 lymphadenectomy improves the survival of patients with gastric cancer and should therefore be performed routinely or selectively .
BACKGROUND	The aim of this multicentre randomized trial was to compare D2 and D1 lymphadenectomy in the treatment of gastric cancer .
METHODS	Between June 1998 and December 2006 , patients with gastric adenocarcinoma were assigned randomly to either D1 or D2 gastrectomy .
METHODS	Intraoperative randomization was implemented centrally by telephone .
METHODS	Primary outcome was overall survival ; secondary endpoints were disease-specific survival , morbidity and postoperative mortality .
RESULTS	A total of 267 eligible patients were allocated to either D1 ( 133 patients ) or D2 ( 134 ) resection .
RESULTS	Morbidity ( 12.0 versus 17.9 per cent respectively ; P = 0.183 ) and operative mortality ( 3.0 versus 2.2 per cent ; P = 0.725 ) rates did not differ significantly between the groups .
RESULTS	Median follow-up was 8.8 ( range 4.5-13 .1 ) years for surviving patients and 2.4 ( 0.2-11 .9 ) years for those who died , and was not different in the two treatment arms .
RESULTS	There was no difference in the overall 5-year survival rate ( 66.5 versus 64.2 per cent for D1 and D2 lymphadenectomy respectively ; P = 0.695 ) .
RESULTS	Subgroup analyses showed a 5-year disease-specific survival benefit for patients with pathological tumour ( pT ) 1 disease in the D1 group ( 98 per cent versus 83 per cent for the D2 group ; P = 0.015 ) , and for patients with pT2-4 status and positive lymph nodes in the D2 group ( 59 per cent versus 38 per cent for the D1 group ; P = 0.055 ) .
CONCLUSIONS	No difference was found in overall 5-year survival between D1 and D2 resection .
CONCLUSIONS	Subgroup analyses suggest that D2 lymphadenectomy may be a better choice in patients with advanced disease and lymph node metastases .
BACKGROUND	ISRCTN11154654 ( http://www.controlled-trials.com ) .

###24355659
OBJECTIVE	Patients with lymphoma are at higher-risk of secondary malignancies mainly due to effects of cancer therapy as well as frequent radiological surveillance .
OBJECTIVE	We thus aimed to investigate the objective and subjective image quality as well as radiation exposure and risk of full-dose standard ( FDS ) , full-dose iterative ( FDI ) , and half-dose iterative ( HDI ) image reconstruction in patients with lymphoma .
METHODS	In 100 lymphoma patients , contrast-enhanced whole-body staging was performed on a dual-source CT. .
METHODS	To acquire full-dose and half-dose CT data simultaneously , the total current-time product was equally distributed on both tubes operating at 120 kV .
METHODS	HDI reconstructions were calculated by using only data from one tube .
METHODS	Quantitative image quality was assessed by measuring image noise in different tissues of the neck , thorax , and abdomen .
METHODS	Overall diagnostic image quality was assessed using a 5-point Likert scale .
METHODS	Radiation doses and risks were estimated for a male and female reference person .
RESULTS	For all anatomical regions apart from the lungs image noise was significantly lower and the overall subjective image quality significantly better when using FDI and HDI instead of FDS reconstruction ( p < 0.05 ) .
RESULTS	For the half-dose protocol , the risk to develop a radiation-induced cancer was estimated to be less than 0.11 / 0.19 % for an adult male/female .
CONCLUSIONS	Image quality of FDI and more importantly of HDI is superior to FDS reconstruction , thus enabling to halve radiation dose and risk to lymphoma patients .

###24877717
OBJECTIVE	The aim of this study was to investigate the potential benefits of an extract obtained from seeds/fruits of an Oleaceae ( Fraxinus excelsior L. ) on glucose homeostasis and associated metabolic markers in non-diabetic overweight/obese subjects .
METHODS	This study was performed in 22 participants ( 50-80 years-old ; BMI 31.0 kg/m ( 2 ) ) .
METHODS	The design was a longitudinal , randomized , crossover , double-blind , placebo-controlled 7-week nutritional intervention .
METHODS	The participants received daily 3 capsules each containing either 333 mg of an extract from Fraxinus excelsior L. seeds ( Glucevia ( ) ) or placebo capsules ( control ) in a random order for 3 weeks with 1 week of washout between treatments .
METHODS	Moreover , they followed a balanced covert energy-restricted diet ( -15 % energy ) .
METHODS	All variables were measured at the beginning and at the end of each period .
RESULTS	Compared to baseline , the administration of 1 g of Glucevia ( ) for 3 weeks resulted in significantly lower incremental glucose area under the curve ( -28.2 % ; p < 0.01 ) , and significantly lower 2 h blood glucose values ( -14 % ; p < 0.01 ) following an oral glucose tolerance test .
RESULTS	No significant changes were found in the control group ( -7.9 % AUC , -1.6 % 2h blood glucose ) .
RESULTS	Furthermore , significant differences were found between responses in the control and Glucevia ( ) groups with respect to serum fructosamine and plasma glucagon levels ( p < 0.01 and p < 0.05 , respectively ) .
RESULTS	Interestingly , administration of Glucevia ( ) significantly increased the adiponectin : leptin ratio ( p < 0.05 ) and decreased fat mass ( p < 0.01 ) compared to control ( p < 0.05 ) .
CONCLUSIONS	The administration of an extract from Fraxinus excelsior L. seeds/fruits in combination with a moderate hypocaloric diet may be beneficial in metabolic disturbances linked to impaired glucose tolerance , obesity , insulin resistance and inflammatory status , specifically in older adults .

###25274892
OBJECTIVE	With modern initial aggressive combination treatments with synthetic disease-modifying antirheumatic drugs ( sDMARD ) , most patients with rheumatoid arthritis ( RA ) achieve remission , have marginal radiographic progression , and sustain normal function .
OBJECTIVE	Here we aim to identify the patients failing these targets even after aggressive treatment .
METHODS	Ninety-nine patients with early , active RA were treated with a combination of 3 sDMARD and prednisolone ( PRD ) , and either infliximab or placebo infusions during the first 6 months , aiming at strict remission .
METHODS	After 24 months , the treatments became unrestricted .
METHODS	At 60 months , 4 evident clinical features of treatment failure were defined : area under curve ( AUC ) between 6-60 months for disease activity score assessing 28 joints > 2.6 ; AUC 6-60 for health assessment questionnaire > 0.5 ; progression in total Sharp/van der Heijde score 0-60 months > 3 units ; and need of PRD or biologic DMARD treatment at 60 months .
RESULTS	A total of 93 patients were followed up for 60 months .
RESULTS	Of them , 45 had no features of treatment failure , 30 had 1 , 10 had 2 , 7 had 3 , and 1 patient had all 4 features .
RESULTS	Having 2-4 features of treatment failure at 5 years was predicted by the health assessment score at baseline , and by even low residual disease activity at 3 and 6 months .
CONCLUSIONS	Only 20 % of the patients with RA treated early with combination sDMARD and PRD have more than 1 clinical feature of treatment failure at 60 months .
CONCLUSIONS	Residual clinical disease activity at 3-6 months was the most important predictor for identifying these patients .
CONCLUSIONS	The study was registered at www.clintrials.gov ( NCT00908089 ) .

###24499060
BACKGROUND	Anxiety , depressive and substance use disorders account for three quarters of the disability attributed to mental disorders and frequently co-occur .
BACKGROUND	While programs for the prevention and reduction of symptoms associated with ( i ) substance use and ( ii ) mental health disorders exist , research is yet to determine if a combined approach is more effective .
BACKGROUND	This paper describes the study protocol of a cluster randomised controlled trial to evaluate the effectiveness of the CLIMATE Schools Combined intervention , a universal approach to preventing substance use and mental health problems among adolescents .
METHODS	Participants will consist of approximately 8400 students aged 13 to 14-years-old from 84 secondary schools in New South Wales , Western Australia and Queensland , Australia .
METHODS	The schools will be cluster randomised to one of four groups ; ( i ) CLIMATE Schools Combined intervention ; ( ii ) CLIMATE Schools - Substance Use ; ( iii ) CLIMATE Schools - Mental Health , or ( iv ) Control ( Health and Physical Education as usual ) .
METHODS	The primary outcomes of the trial will be the uptake and harmful use of alcohol and other drugs , mental health symptomatology and anxiety , depression and substance use knowledge .
METHODS	Secondary outcomes include substance use related harms , self-efficacy to resist peer pressure , general disability , and truancy .
METHODS	The link between personality and substance use will also be examined .
CONCLUSIONS	Compared to students who receive the universal CLIMATE Schools - Substance Use , or CLIMATE Schools - Mental Health or the Control condition ( who received usual Health and Physical Education ) , we expect students who receive the CLIMATE Schools Combined intervention to show greater delays to the initiation of substance use , reductions in substance use and mental health symptoms , and increased substance use and mental health knowledge .
BACKGROUND	This trial is registered with the Australian and New Zealand Clinical Trials registry , ACTRN12613000723785 .

###25415805
BACKGROUND	Hyperkalemia increases the risk of death and limits the use of inhibitors of the renin-angiotensin-aldosterone system ( RAAS ) in high-risk patients .
BACKGROUND	We assessed the safety and efficacy of patiromer , a nonabsorbed potassium binder , in a multicenter , prospective trial .
METHODS	Patients with chronic kidney disease who were receiving RAAS inhibitors and who had serum potassium levels of 5.1 to less than 6.5 mmol per liter received patiromer ( at an initial dose of 4.2 g or 8.4 g twice a day ) for 4 weeks ( initial treatment phase ) ; the primary efficacy end point was the mean change in the serum potassium level from baseline to week 4 .
METHODS	Eligible patients at the end of week 4 ( those with a baseline potassium level of 5.5 to < 6.5 mmol per liter in whom the level decreased to 3.8 to < 5.1 mmol per liter ) entered an 8-week randomized withdrawal phase in which they were randomly assigned to continue patiromer or switch to placebo ; the primary efficacy end point was the between-group difference in the median change in the serum potassium level over the first 4 weeks of that phase .
RESULTS	In the initial treatment phase , among 237 patients receiving patiromer who had at least one potassium measurement at a scheduled visit after day 3 , the mean ( SE ) change in the serum potassium level was -1.010.03 mmol per liter ( P < 0.001 ) .
RESULTS	At week 4 , 76 % ( 95 % confidence interval , 70 to 81 ) of the patients had reached the target potassium level ( 3.8 to < 5.1 mmol per liter ) .
RESULTS	Subsequently , 107 patients were randomly assigned to patiromer ( 55 patients ) or placebo ( 52 patients ) for the randomized withdrawal phase .
RESULTS	The median increase in the potassium level from baseline of that phase was greater with placebo than with patiromer ( P < 0.001 ) ; a recurrence of hyperkalemia ( potassium level , 5.5 mmol per liter ) occurred in 60 % of the patients in the placebo group as compared with 15 % in the patiromer group through week 8 ( P < 0.001 ) .
RESULTS	Mild-to-moderate constipation was the most common adverse event ( in 11 % of the patients ) ; hypokalemia occurred in 3 % .
CONCLUSIONS	In patients with chronic kidney disease who were receiving RAAS inhibitors and who had hyperkalemia , patiromer treatment was associated with a decrease in serum potassium levels and , as compared with placebo , a reduction in the recurrence of hyperkalemia .
CONCLUSIONS	( Funded by Relypsa ; OPAL-HK ClinicalTrials.gov number , NCT01810939 . )

###25300221
BACKGROUND	The implementation of healthy school canteen policies has been recommended as a strategy to help prevent unhealthy eating and excessive weight gain .
BACKGROUND	Internationally , research suggests that schools often fail to implement practices consistent with healthy school canteen policies .
BACKGROUND	Without a population wide implementation , the potential benefits of these policies will not be realised .
BACKGROUND	The aim of this trial is to assess the effectiveness of an implementation intervention in increasing school canteen practices consistent with a healthy canteen policy of the New South Wales ( NSW ) , Australia , government known as the ` Fresh Tastes @ School NSW Healthy School Canteen Strategy ' .
METHODS	The parallel randomised trial will be conducted in 70 primary schools located in the Hunter region of New South Wales , Australia .
METHODS	Schools will be eligible to participate if they are not currently meeting key components of the healthy canteen policy .
METHODS	Schools will be randomly allocated after baseline data collection in a 1:1 ratio to either an intervention or control group using a computerised random number function in Microsoft Excel .
METHODS	Thirty-five schools will be selected to receive a multi-component intervention including implementation support from research staff , staff training , resources , recognition and incentives , consensus and leadership strategies , follow-up support and implementation feedback .
METHODS	The 35 schools allocated to the control group will not receive any intervention support as part of the research trial .
METHODS	The primary outcome measures will be i ) the proportion of schools with a canteen menu that does not contain foods or beverages restricted from regular sale ( ` red ' and ` banned ' items ) and ii ) the proportion of schools where healthy canteen items ( ` green ' items ) represent the majority ( > 50 % ) of products listed on the menu .
METHODS	Outcome data will be collected via a comprehensive menu audit , conducted by dietitians blind to group allocation .
METHODS	Intervention effectiveness will be assessed using logistic regression models adjusting for baseline values .
CONCLUSIONS	The proposed trial will represent a novel contribution to the literature , being the first randomised trial internationally to examine the effectiveness of an intervention to facilitate implementation of a healthy canteen policy .
BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12613000311752 .

###24925270
BACKGROUND	Adherence to the Mediterranean diet ( MD ) is associated with reduced morbidity and mortality due to cardiovascular disease .
BACKGROUND	However , how the MD exerts its effects is not fully known .
OBJECTIVE	To assess the 12-month effects of two enhanced MDs compared to a low-fat diet on inflammatory biomarkers related to atherosclerosis and plaque vulnerability in a subcohort of the PREDIMED ( Prevencin con Dieta Mediterrnea ) study .
METHODS	A total of 164 participants at high risk for cardiovascular disease were randomized into three diet groups : MD supplemented with 50mL/d of extra virgin olive oil ( MD+EVOO ) or 30 g/d of nuts ( MD+N uts ) and a low-fat diet .
METHODS	Changes in classical cardiovascular risk factors , inflammatory biomarkers of atherosclerosis and plaque vulnerability were measured after 12 months of intervention .
RESULTS	Compared to participants in the low-fat diet group , those receiving MD+EVOO and MD+N uts showed a higher decrease in systolic ( 6mmHg ) and diastolic ( 3mmHg ) blood pressure ( P = 0.02 ; both ) , as well as a reduction of 10 % and 8 % in LDL-cholesterol ( P = 0.04 ) , respectively .
RESULTS	Patients in the MD+N uts group showed a significant reduction of 34 % in CD40 expression on monocyte surface compared to low-fat diet patients ( P = 0.03 ) .
RESULTS	In addition , inflammatory biomarkers related to plaque instability such as C-reactive protein and interleukin-6 were reduced by 45 % and 35 % and 95 % and 90 % in the MD+EVOO and MD+N uts groups , respectively ( P < 0.05 ; all ) compared to the low-fat diet group .
RESULTS	Likewise , sICAM and P-selectin were also reduced by 50 % and 27 % , respectively in the MD+EVOO group ( P = 0.04 ) and P-selectin by 19 % in MD+N uts group ( P = 0.04 ) compared to the low-fat diet group .
CONCLUSIONS	Adherence to the MD is associated with an increase in serum markers of atheroma plaque stability which may explain , at least in part , the protective role of MD against ischemic heart disease .
BACKGROUND	www.controlled-trials.com ISRCTN35739639 .

###24468078
BACKGROUND	External cephalic version ( ECV ) is offered to reduce the number of Caesarean delivery indicated by breech presentation which occurs in 3-4 % of term pregnancies .
BACKGROUND	ECV is commonly performed aided by the application of aqueous gel or talcum powder to the maternal abdomen .
BACKGROUND	We sought to compare gel with powder during ECV on achieving successful version and increasing tolerability .
METHODS	We enrolled 95 women ( 36 weeks gestation ) on their attendance for planned ECV .
METHODS	All participants received terbutaline tocolysis .
METHODS	Regional anaesthesia was not used .
METHODS	ECV was performed in the standard fashion after the application of the allocated aid .
METHODS	If the first round ( maximum of 2 attempts ) of ECV failed , crossover to the opposing aid was permitted .
RESULTS	48 women were randomised to powder and 47 to gel .
RESULTS	Self-reported procedure related median [ interquartile range ] pain scores ( using a 10-point visual numerical rating scale VNRS ; low score more pain ) were 6 [ 5-9 ] vs. 8 [ 7-9 ] P = 0.03 in favor of gel .
RESULTS	ECV was successful in 21/48 ( 43.8 % ) vs. 26/47 ( 55.3 % ) RR 0.6 95 % CI 0.3-1 .4 P = 0.3 for powder and gel arms respectively .
RESULTS	Crossover to the opposing aid and a second round of ECV was performed in 13/27 ( 48.1 % ) following initial failure with powder and 4/21 ( 19 % ) after failure with gel ( RR 3.9 95 % CI 1.0-15 P = 0.07 ) .
RESULTS	ECV success rate was 5/13 ( 38.5 % ) vs. 1/4 ( 25 % ) P = 0.99 after crossover use of gel or powder respectively .
RESULTS	Operators reported higher satisfaction score with the use of gel ( high score , greater satisfaction ) VNRS scores 6 [ 4.25-8 ] vs 8 [ 7-9 ] P = 0.01 .
CONCLUSIONS	Women find gel use to be associated with less pain .
CONCLUSIONS	The ECV success rate is not significantly different .
BACKGROUND	The trial is registered with ISRCTN ( identifier ISRCTN87231556 ) .

###24652032
OBJECTIVE	Effective patient/provider communication is important to ensure patient understanding , safety , and satisfaction .
OBJECTIVE	Our hypothesis was that interactive patient/provider counseling using a web-based tool ( iPad application ) would have a greater impact on patient satisfaction with understanding prolapse symptoms compared with standard counseling ( SC ) .
METHODS	Women with complaints of seeing/sensing a vaginal bulge were enrolled in this randomized controlled trial .
METHODS	Participants completed pre - and postvisit Likert scale questionnaires on satisfaction with prolapse knowledge and related anxiety .
METHODS	After new patient histories and physical examinations , study participants were randomized to SC or SC with iPad .
METHODS	Ninety participants were required to detect a 30 % difference in satisfaction with prolapse knowledge between the two groups .
RESULTS	Ninety women were randomized to SC ( n = 44 ) or SC with iPad ( n = 46 ) .
RESULTS	At baseline , 47 % of women were satisfied with their understanding of bulge symptoms ( 50 % SC vs. 43.5 % SC with iPad , p = 0.5 ) .
RESULTS	After counseling , 97 % of women reported increased satisfaction with understanding of bulge symptoms ( p < 0.0001 ) , with no difference between groups [ 42/44 ( 95.5 % ) SC vs. 45/46 ( 97.8 % ) SC with iPad , p = 0.5 ] .
RESULTS	Baseline anxiety was high : 70 % ( 65.9 % SC vs. 73.9 % SC with iPad , p = 0.4 ) .
RESULTS	After counseling , anxiety decreased to 30 % ( p < 0.0001 ) , with improvement in both groups ( 31.8 % SC vs. 28.3 % SC with iPad , p = 0.7 ) .
RESULTS	Counseling times were similar between groups ( 9.5 min. , SC vs. 8.9 min. , SC with iPad , p = 0.4 ) .
CONCLUSIONS	Interactive counseling was associated with increased patient satisfaction with understanding bulge symptoms and decreased anxiety whether a web-based tool was used or not .

###24332139
BACKGROUND	Guidelines for management of hypertension and lipids recommend using cardiovascular absolute risk ( CVAR ) to manage patients .
BACKGROUND	This randomized controlled trial investigated the impact of CVAR assessment in family practice on management of cardiovascular risk , including prescription of antihypertensive and lipid-lowering medication .
METHODS	A cluster randomized controlled trial was conducted from 2008 to 2010 in Sydney , Australia .
METHODS	Family practices were randomized , and patients aged 45 to 69 years were invited to participate .
METHODS	Intervention family physicians ( FP ) were trained in use of CVAR , provided with an electronic CVAR calculator , and assessed their patients ' absolute risk in a dedicated consultation .
METHODS	Control practice patients received a general health check .
METHODS	Primary outcome analyzed was the proportion of patients in each group on antihypertensive and/or lipid-lowering medication at 12 months .
METHODS	Multilevel logistic regression was performed to explore variables influencing changes in pharmacologic therapy .
RESULTS	The study recruited 36 FPs from 34 practices and 1,074 patients , of which 906 ( 84.4 % ) completed 12-month follow-up .
RESULTS	At 12 months , there was no significant difference between the intervention and control groups in proportion of patients on antihypertensives ( 31.2 % vs 34.3 % , P = .31 ) , but control group patients were more likely to be on lipid-lowering medications ( 30.2 % vs 22.7 % , P = .01 ) .
RESULTS	After multilevel analysis , this difference was not present .
RESULTS	Intensification or reduction of pharmacologic therapy was associated with meeting treatment targets for blood pressure and lipids but not with the CVAR or intervention group .
CONCLUSIONS	Single-risk factor management remains a strong influence on FP prescribing practices .
CONCLUSIONS	Shifting to an approach based on CVAR will require more intensive intervention .

###24552826
BACKGROUND	Chronic obstructive pulmonary disease ( COPD ) is characterized by irreversible airflow limitation and is associated with weight loss and decreased muscle strength and exercise capacity .
METHODS	A double-blinded randomized controlled trial of 32 male COPD patients ( age , 54.94 11.27 years ) was carried out to assess effects of anabolic steroid in terms of a daily high-protein , high-calorie diet alone or one combined with anabolic steroids on body composition , lung function , and health-related quality of life ( HRQL ) .
METHODS	Outcomes were assessed by anthropometric and spirometric measurements , peak expiratory flow rate , partial pressure of oxygen in arterial blood , 6-minute walk test ( 6MWT ) , hand grip test , and HRQL index scores .
METHODS	Measurements were made at baseline and end of treatment ( 6 weeks ) .
RESULTS	All patients showed significant difference ( P < .001 ) in pulmonary function parameters and anthropometric measurements after 6 weeks of intervention ( within-group changes ) ; however , no significant improvement occurred in the pulmonary function parameters between the groups .
RESULTS	The difference in exercise capacity ( 6MWT ) and HRQL scores in the treatment group were statistically significant ( P < .001 ) compared with control group after 6 weeks of intervention .
RESULTS	In the treatment group , the average 6MWT distance increased from 213.5 m to 268.5 m at 6-week follow-up , and HRQL scores increased from 101.25 to 118.45 .
RESULTS	Also , HRQL and 6MWT parameters were positively correlated in response to steroid supplementation at the end of the study .
CONCLUSIONS	Weekly administration of anabolic steroids during 6 weeks increased exercise capacity and quality of life in patients with COPD .

###25262251
OBJECTIVE	Implantable cardioverter defibrillator ( ICD ) remote follow-up and ICD remote monitoring ( RM ) are established means of ICD follow-up .
OBJECTIVE	The reduction of the number of in-office visits and the time to decision is proven , but the true clinical benefit is still unknown .
OBJECTIVE	Cost and cost-effectiveness of RM remain leading issues for its dissemination .
OBJECTIVE	The MONITOR-ICD study has been designed to assess costs , cost-effectiveness , and clinical benefits of RM versus standard-care follow-up in a prospective multicenter randomized controlled trial .
RESULTS	Patients indicated for single - or dual-chamber ICD are eligible for the study and are implanted an RM-capable Biotronik ICD ( Lumax VR-T or Lumax DR-T ; Biotronik SE & Co KG , Berlin , Germany ) .
RESULTS	Implantable cardioverter defibrillator programming and alert-based clinical responses in the RM group are highly standardized by protocol .
RESULTS	As of December 2011 , recruitment has been completed , and 416 patients have been enrolled .
RESULTS	Subjects are followed-up for a minimum of 12months and a maximum of 24months , ending in January 2013 .
RESULTS	Disease-specific costs from a societal perspective have been defined as primary end point and will be compared between RM and standard-care groups .
RESULTS	Secondary end points include ICD shocks ( including appropriate and inappropriate shocks ) , cardiovascular hospitalizations and cardiovascular mortality , and additional health economic end points .
CONCLUSIONS	The MONITOR-ICD study will be an important randomized RM study to report data on a primary economic end point in 2014 .
CONCLUSIONS	Its results on ICD shocks will add to the currently available evidence on clinical benefit of RM .

###24518152
OBJECTIVE	This study aims to assess the effects of proanthocyanidin-a class of polyphenol antioxidants extracted from grape seeds-on menopausal symptoms , body composition , and cardiovascular parameters in middle-aged women .
METHODS	We conducted a randomized , double-blind , placebo-controlled study in 96 women aged 40 to 60 years who had at least one menopausal symptom .
METHODS	The study participants were randomized to receive grape seed extract tablets containing either low-dose ( 100 mg/d ) or high-dose ( 200 mg/d ) proanthocyanidin , or placebo , for 8 weeks .
METHODS	Their menopausal symptoms were evaluated using the Menopausal Health-Related Quality of Life Questionnaire , Hospital Anxiety and Depression Scale , and Athens Insomnia Scale before and after 4 and 8 weeks of treatment .
METHODS	Body composition and cardiovascular parameters were also measured .
RESULTS	A total of 91 women ( 95 % ) completed the study .
RESULTS	Background characteristics , including age , menopause status , subjective symptom scores , body composition , and cardiovascular parameters , were similar among the groups .
RESULTS	The following significant changes were observed during the course of the study : ( 1 ) physical symptom score , hot flash score , and ( 2 ) Athens Insomnia Scale score decreased in the high-dose group after 8 weeks of treatment ; ( 3 ) Hospital Anxiety and Depression Scale Anxiety score and ( 4 ) systolic and diastolic blood pressure decreased in the low-dose and high-dose groups after 4 weeks ; and , ( 5 ) lastly , muscle mass increased in the low-dose and high-dose groups after 8 weeks of treatment .
CONCLUSIONS	Grape seed proanthocyanidin extract is effective in improving the physical and psychological symptoms of menopause while increasing muscle mass and reducing blood pressure in middle-aged women .

###24766760
OBJECTIVE	Medications for the treatment of substance use disorders ( SUDs ) are not widely available in publicly funded SUD treatment programs .
OBJECTIVE	Few studies have drawn on longitudinal data to examine the organizational characteristics associated with programs transitioning from not delivering any pharmacotherapy to adopting at least one SUD medication .
METHODS	Using two waves of panel longitudinal data collected over a 5-year period , we measured the transition to medication adoption in a cohort of 190 publicly funded treatment organizations that offered no SUD medications at baseline .
METHODS	Independent variables included organizational characteristics , medical resources , funding , treatment culture , and detailing activities by pharmaceutical companies .
RESULTS	Of 190 programs not offering SUD pharmacotherapy at baseline , 22.6 % transitioned to offering at least one SUD medication at follow-up approximately 5 years later .
RESULTS	Multivariate logistic regression results indicated that the employment of at least one physician at baseline , having a greater proportion of Medicaid clients , and pharmaceutical detailing were positively associated with medication adoption .
CONCLUSIONS	Adoption of pharmacotherapy was more likely in programs that had greater medical resources , Medicaid funding , and contact with pharmaceutical companies .
CONCLUSIONS	Given the potential expansion of Medicaid under the Affordable Care Act , patients served by publicly funded programs may gain greater access to such treatments , but research is needed to document health reform 's impact on this sector of the treatment system .

###25462647
OBJECTIVE	The relationship between alcohol use and risky sexual behavior is complex and depends on psychological and environmental factors .
OBJECTIVE	The alcohol myopia model predicts that , due to alcohol 's impact on attention , the behavior of intoxicated individuals will become increasingly directed by salient cues .
OBJECTIVE	Autonomic arousal ( AA ) may have a similar effect on attention .
OBJECTIVE	Experiential delay discounting ( DD ) may be increased by both alcohol consumption and AA due to their common effects and may mediate the relationship between these conditions and risky sex .
METHODS	This study employed a 3 ( alcohol , placebo , control ) 2 ( high , low arousal ) experimental design to examine the effects of acute alcohol intoxication and AA on experiential delay discounting , subjective sexual arousal , and risky sex .
RESULTS	Path models revealed complex results that only partially supported study hypotheses .
RESULTS	Ratings of subjective sexual arousal did not differ across either beverage or arousal conditions .
RESULTS	DD was also unrelated to any study variable .
RESULTS	However , subjective sexual arousal was positively related to risky sexual intentions .
RESULTS	Alcohol intoxication was also positively associated with increased unprotected sex intentions , consistent with past studies .
CONCLUSIONS	These results affirm the role of subjective sexual arousal and alcohol intoxication in risky sexual decision-making , yielding effect sizes similar to comparable past studies .
CONCLUSIONS	The lack of differences across autonomic arousal groups also suggests that effects of attentional myopia may be behavior-specific .
CONCLUSIONS	Failure to replicate effects of alcohol intoxication on DD also suggests reservation regarding its involvement in alcohol-involved risky sex .

###24619298
OBJECTIVE	This study was designed to evaluate the response and toxicity of sorafenib alone or when combined with carboplatin and paclitaxel in patients with platinum-sensitive , recurrent ovarian cancer , fallopian tube cancer , or primary peritoneal cancer ( EOC ) .
METHODS	Patients with recurrent platinum-sensitive EOC with no more than 2 prior courses of chemotherapy were randomized to single-agent sorafenib 400 mg twice daily or combination sorafenib 400 mg bid ( days 2-19 ) with IV carboplatin ( AUC 6 ) and IV paclitaxel 175 mg/m ( 2 ) ( S+C / T ) every 3 weeks .
METHODS	Single agent sorafenib could cross over to combination upon progression .
RESULTS	Patients were initially randomized to either arm , however , due to poor accrual , sorafenib arm was prematurely closed .
RESULTS	A total of 13 patients were evaluable for response to sorafenib and 23 patients were evaluable for response to S+C / T. Objective response rate ( RR ) was 15 % for patients on sorafenib vs. 61 % for patients on S+C / T ( p = 0.014 ) ; stable disease was seen in 62 % and 35 % , respectively .
RESULTS	Clinical benefit rate ( CBR ) at 4 months ( mos . )
RESULTS	was 69 % for S and 65 % for S+C / T.
RESULTS	The median progression free survival was 5.6 months on sorafenib vs. 16.8 months on S+C / T ( p = 0.012 ) and there was no significant difference of overall survival between two arms ( p = 0.974 ) with median overall survival 25.6 months under sorafenib vs. 25.9 months on S+C / T. Patients remained on trial for a median of 7.8 cycles on sorafenib and 5.4 cycles on S+C / T.
CONCLUSIONS	Sorafenib , alone or in combination with carboplatin and paclitaxel , has activity in patients with platinum-sensitive EOC .
CONCLUSIONS	Sorafenib in combination with carboplatin and paclitaxel improved RR and PFS ; however , there were increased grade and frequencies of toxicities .

###24286136
BACKGROUND	The aim of this study was to evaluate the safety , pharmacokinetics , and clinical response of brodalumab ( AMG 827 ) , a human , anti-IL-17 receptor A ( IL-17RA ) monoclonal antibody in subjects with moderate-to-severe rheumatoid arthritis ( RA ) .
METHODS	This phase Ib , randomized , placebo-controlled , double-blind multiple ascending dose study enrolled subjects with moderate to severe RA ( 6/66 swollen and 8/68 tender joints ) .
METHODS	Subjects were randomized 3:1 to receive brodalumab ( 50 mg , 140 mg , or 210 mg subcutaneously every two weeks for 6 doses per group ; or 420 mg or 700 mg intravenously every 4 weeks for two doses per group ) or placebo .
METHODS	Endpoints included incidence of adverse events ( AEs ) and pharmacokinetics .
METHODS	Exploratory endpoints included pharmacodynamics , and improvements in RA clinical metrics .
RESULTS	Forty subjects were randomized to investigational product ; one subject discontinued due to worsening of RA ( placebo ) .
RESULTS	The study was not designed to assess efficacy .
RESULTS	AEs were reported by 70 % ( 7/10 ) of placebo subjects and 77 % ( 22/30 ) of brodalumab subjects .
RESULTS	Three serious AEs were reported in two subjects ; there were no opportunistic infections .
RESULTS	Brodalumab treatment resulted in inhibition of IL-17 receptor signaling and receptor occupancy on circulating leukocytes .
RESULTS	No treatment effects were observed with individual measures of RA disease activity .
RESULTS	On day 85 ( week 13 ) 37 % ( 11/30 ) of brodalumab subjects and 22 % ( 2/9 ) of placebo subjects achieved ACR20 ; 7 % ( 2/30 ) brodalumab subjects and 11 % ( 1/9 ) of placebo subjects achieved ACR50 ; and 0 % ( 0/30 ) brodalumab subjects and 0 % ( 0/9 ) of placebo subjects achieved ACR70 .
CONCLUSIONS	Multiple dose administration of brodalumab was tolerated in subjects with active RA .
CONCLUSIONS	There was no evidence of a clinical response to brodalumab in subjects with RA .
BACKGROUND	ClinicalTrials.gov , NCT00771030 .

###25304789
OBJECTIVE	To evaluate whether the daily intake of synbiotics interferes in radiation-induced acute proctitis symptoms and in quality of life in patients with prostate cancer .
METHODS	Twenty patients who underwent 3-dimensional conformal radiation therapy for prostate cancer were randomized to intake either a synbiotic powder containing Lactobacillus reuteri 10 ( 8 ) colony-forming units and 4.3 g of soluble fiber ( Nestl ) or placebo .
METHODS	The questionnaire EORTC QLQ-PRT23 was applied before the beginning of radiation therapy and in every week for the first 4 weeks of treatment .
METHODS	The sum of both the complete ( proctitis symptoms plus quality of life ) and partial ( proctitis symptoms ) scores of the EORTC QLQ-PRT23 ( European Organization for Research and Treatment of Cancer Quality of Life Module for Proctitis-23 items ) questionnaire were the main endpoints .
RESULTS	This pilot study showed that the complete questionnaire score ( median [ range ] ) was higher in the second ( 23 [ 21-30 ] vs 26.5 [ 22-34 ] , P < .05 ) and third ( 23 [ 21-32 ] vs 27.5 [ 24-33 ] , P < .01 ) weeks in the placebo group .
RESULTS	Proctitis symptoms were highest scored in the placebo group in both the second ( 19.5 [ 16-25 ] ) and third ( 19 [ 17-24 ] ) weeks than in the synbiotic group ( week 2 : 16.5 [ 15-20 ] , P < .05 ; week 3 : 17 [ 15-23 ] , P < .01 ) .
RESULTS	In both scores the placebo group had a significantly higher result ( P < .01 ) than the synbiotic group ( repeated-measures analysis of variance ) .
CONCLUSIONS	Synbiotics reduce proctitis symptoms and improve quality of life in radiation-induced acute proctitis during radiation therapy for prostate cancer .

###24434659
OBJECTIVE	To evaluate the safety of two commercially available formulations of bimatoprost eye drops : 0.03 and 0.01 % ophthalmic solutions .
METHODS	This was a randomized , prospective , parallel-group , open-label , cohort study .
METHODS	A total of 60 glaucoma patients ( 60 eyes ) under bimatoprost 0.03 % monotherapy since at least 1 year were enrolled .
METHODS	Selected patients were randomized to receive a single drop of bimatoprost 0.01 % ( n = 30 ) or bimatoprost 0.03 % ( n = 30 ) ophthalmic solutions for 12 months .
METHODS	Statistical analysis was performed using paired t-test and repeated measures ANOVA test .
RESULTS	Global clinical score ( the sum of pruritus , stinging/burning , blurred vision , sticky eye sensation , eye dryness sensation , and foreign body sensation ) significantly decreased in the bimatoprost 0.01 % group from baseline 4.7 3.8 to 2.9 2.3 ( P < 0.001 ) and 2.5 2.0 ( P < 0.001 ) at 6-month and 12-month follow-ups , respectively .
RESULTS	Comparison between groups showed differences at both follow-up visits ( P = 0.003 and P < 0.001 , respectively ) .
RESULTS	In vivo confocal microscopy revealed a significant increase in goblet cell density in the bimatoprost 0.01 % group compared with the bimatoprost 0.03 % group ( P < 0.001 at both follow-up visits ) .
RESULTS	All functional parameters and conjunctival hyperemia improved in the bimatoprost 0.01 % group at each follow-up visit ( P < 0.05 ) and in comparison with bimatoprost 0.03 % ( P < 0.05 ) .
CONCLUSIONS	The results of this trial suggest that bimatoprost 0.01 % eye drops seem to decrease the ocular discomfort with respect to bimatoprost 0.03 % eye drops .

###24379032
OBJECTIVE	Type 1 diabetes mellitus ( T1DM ) is caused by insulin deficiency resulting from progressive destruction of cells .
OBJECTIVE	The histological hallmark of the diabetic islet is mononuclear cell infiltration .
OBJECTIVE	Thiazolidinediones ( TZDs ) activate PPARg and enhance the actions of insulin .
OBJECTIVE	Studies in non-obese diabetic and streptocotozin-treated mouse models demonstrated that pretreatment with TZDs prevented the development of T1DM .
OBJECTIVE	The purpose of this study was to examine whether pioglitazone , given with insulin , preserved cell function in patients with new-onset T1DM .
METHODS	This was a randomized , double-blind , placebo-controlled 24-week study .
METHODS	Subjects received pioglitazone or placebo .
METHODS	Blood sugar , glycated hemoglobin ( HbA1c ) , C-peptide , and liver enzymes were measured at baseline .
METHODS	Boost stimulated C-peptide responses were measured at baseline and at 24 weeks .
METHODS	Blood sugar , insulin dose , height , weight , and liver enzymes were monitored at each visit .
METHODS	HbA1c was performed every 12 weeks .
RESULTS	Of the 15 patients , 8 received pioglitazone , and 7 - placebo .
RESULTS	There was no clinical improvement in HbA1c between or within groups at the completion of the study .
RESULTS	Mean peak C-peptide values were similar between groups at baseline .
RESULTS	Mean peak C-peptide level was slightly higher at 24 weeks in the pioglitazone group compared to the placebo ( 1.8 vs. 1.5 ng/mL ) which was considered as clinically insignificant .
RESULTS	The interaction of HbA1c and insulin dose ( HbA1c * insulin/kg/day ) , which combines degree of diabetic control and dose of insulin required to achieve this control , showed transient improvement in the pioglitazone group at 12 weeks but was not sustained at 24 weeks .
CONCLUSIONS	In this pilot study , pioglitazone did not preserve cell function when compared to placebo .

###25964594
OBJECTIVE	Based on a radiobiological assumption of a low alpha/beta ( / ) ratio for prostate cancer , hypofractionated radiotherapy has increasingly gained traction in the clinical practice and recent guidelines have confirmed the non-inferiority of this approach .
OBJECTIVE	Nevertheless , the largest studies that have used hypofractionation so far , employed image-guided radiation therapy/intensity modulated radiation therapy ( IGRT/IMRT ) facilities that might have overcome the radiobiological advantages , which remain to be fully confirmed .
OBJECTIVE	The aim of this trial was to evaluate the feasibility of a hypofractionated schedule delivered with 3D-Conformal Radiotherapy to prostate and seminal vesicles in combination with hormonal therapy .
METHODS	The study included 97 consecutive patients with localized prostate cancer ( PCa ) , irrespective of risk class , treated with a schedule of 62 Gy in 20 fractions over 5 weeks ( 4 fractions of 3.1 Gy each per week ) .
METHODS	According to National Comprehensive Cancer Network ( NCCN ) prognostic classification , patients were divided into a favourable group ( 19 % ) , intermediate group ( 41 % ) and unfavourable group ( 40 % ) .
METHODS	Early and late toxicities were scored using the radiation toxicity grading/European Organisation for Research and Treatment of Cancer ( RTOG/EORTC ) criteria .
METHODS	Additionally , the international prostate symptom index ( IPSS ) for benign prostate hypertrophy was used to evaluate obstructive urinary symptoms .
METHODS	Biochemical outcome was reported according to the Phoenix definition for biochemical failure .
METHODS	Hormonal therapy ( HT ) was administrated in 92 % of patients .
RESULTS	After a median follow-up of 39 months ( range = 25-52 ) , maximum G2 late genitourinary ( GU ) and gastrointestinal ( GI ) toxicities occurred in 8 % and 11 % patients , respectively .
RESULTS	The corresponding figures for acute toxicities were 24 % and 15 % .
RESULTS	Patients with higher IPSS score before enrolment had significantly worse urinary function after treatment .
RESULTS	Only 2 % of patients died from PCa .
RESULTS	Biochemical non-evidence of disease ( bNED ) was 83 % for all patients .
CONCLUSIONS	Our study confirms that 3D conformal radiotherapy ( 3DCRT ) remains a safe and effective method to deliver a dose-escalated hypofractionated regimen for PCa patients in all risk classes with acceptable toxicity rates and optimal biochemical control .

###25011980
BACKGROUND	The optimal intensity and duration of the intervention to achieve sustained risk reduction in patients at high and very high cardiovascular ( CV ) risk still need to be established .
BACKGROUND	The aim of this study was to evaluate the impact of general practitioner 's ( GP 's ) systematic and planned intervention on total CV risk reduction and a change in individual CV risk factors .
METHODS	This was a cluster-randomized trial ( ISRCTN31857696 ) including 64 practices and 3245 patients aged 40 .
METHODS	The participating GPs and their examinees were randomized into an intervention or to a control group ( standard care ) .
METHODS	Intervention group practitioners followed up their examinees during 1 , 3 , 6 , 12 , and 18 months .
METHODS	The main outcome measures were change in proportion of patients with low , moderate , high , and very high CV risk , and change in individual CV risk factors from the first to the second registration .
RESULTS	The proportion of patients with very high CV risk was lower in the intervention group , the same as of patients with high blood pressure , total and LDL cholesterol , and increased intake of alcohol .
RESULTS	The mean systolic ( -1.49 mmHg ) and diastolic ( -1.57 mmHg ) blood pressure , triglycerides ( -0.18 mmol/L ) , body mass index ( -0.22 ) , and waist ( -0.4 cm ) and hip circumference ( -1.08 cm ) was reduced significantly in the intervention group .
RESULTS	There was no additional impact in the intervention group of other tested CV risk factors .
CONCLUSIONS	Systematic and planned GP 's intervention in CVD prevention reduces the number of patients with very high total CV risk and influences a change in lifestyle habits .

###25481829
BACKGROUND	The study aimed to determine the effect of preference-based tailored navigation on colorectal cancer ( CRC ) screening adherence and related outcomes among African Americans ( AAs ) .
METHODS	We conducted a randomized controlled trial that included 764 AA patients who were age 50 to 75 years , were eligible for CRC screening , and had received care through primary care practices in Philadelphia .
METHODS	Consented patients completed a baseline telephone survey and were randomized to either a Standard Intervention ( SI ) group ( n = 380 ) or a Tailored Navigation Intervention ( TNI ) group ( n = 384 ) .
METHODS	The SI group received a mailed stool blood test kit plus colonoscopy instructions , and a reminder .
METHODS	The TNI group received tailored navigation ( a mailed stool blood test kit or colonoscopy instructions based on preference , plus telephone navigation ) and a reminder .
METHODS	A six-month survey and a 12-month medical records review were completed to assess screening adherence , change in overall screening preference , and perceptions about screening .
METHODS	Multivariable analyses were performed to assess intervention impact on outcomes .
RESULTS	At six months , adherence in the TNI group was statistically significantly higher than in the SI group ( OR = 2.1 , 95 % CI = 1.5 to 2.9 ) .
RESULTS	Positive change in overall screening preference was also statistically significantly greater in the TNI group compared with the SI group ( OR = 1.5 , 95 % CI = 1.0 to 2.3 ) .
RESULTS	There were no statistically significant differences in perceptions about screening between the study groups .
CONCLUSIONS	Tailored navigation in primary care is a promising approach for increasing CRC screening among AAs .
CONCLUSIONS	Research is needed to determine how to maximize intervention effects and to test intervention impact on race-related disparities in mortality and survival .

###24621319
OBJECTIVE	To investigate the safety/tolerability and efficacy of long-term adjunctive zonisamide and its impact on growth and development in children ( 6-18years ) with partial epilepsy .
METHODS	Open-label extension of a phase III , placebo-controlled trial .
METHODS	Started with double-blind transition period ( 2-11weeks ) , during which patients on zonisamide continued at the same dose and those on placebo switched to zonisamide 1mg/kg/day , up-titrated to 8mg/kg/day ( maximum 500mg/day ) .
METHODS	During the subsequent open-label period ( 45-57weeks ) , zonisamide dosing could be adjusted according to tolerability/response .
METHODS	Safety assessments included treatment-emergent adverse events ( TEAEs ) , clinical laboratory parameters , and vital signs .
METHODS	Efficacy assessments included responder rate ( primary assessment ) and seizure freedom rate during the open-label period .
METHODS	Growth and development assessments comprised Tanner stages , hand x-rays , Child Behavior Checklist ( CBCL 6/18 ) , School Performance questionnaire , Physician and Parent/Guardian Global Impression of Change , and Controlled Oral Word Association Test ( COWAT ) .
RESULTS	One hundred forty-four children entered the study ; 99 ( 68.8 % ) of 144 children completed it , and 108 ( 75.0 % ) of 144 received zonisamide for 1year .
RESULTS	TEAEs occurred in 39 ( 27.1 % ) of 144 patients .
RESULTS	There were low incidences of serious TEAEs ( 2.1 % ) and TEAEs leading to discontinuation ( 2.8 % ) .
RESULTS	Bicarbonate level decreases > 3.5 mm occurred in 64 patients ( 44.4 % ) , and 24 patients ( 16.7 % ) had a weight decrease of 10 % from baseline .
RESULTS	During the open-label period , 81 ( 56.3 % ) of 144 patients were responders and 16 ( 11.1 % ) of 144 achieved seizure freedom .
RESULTS	Tanner staging and skeletal development were as expected for the study population .
RESULTS	Changes were minimal for CBCL 6/18 and School Performance scores .
RESULTS	Most patients were `` much improved '' / `` very much improved '' on Physician ( 73.8 % ) and Parent/Guardian ( 75.4 % ) Global Impressions of Change .
RESULTS	Median changes in COWAT Category and Letter Fluency scores were 2.0 and 0.5 , respectively .
CONCLUSIONS	Adjunctive zonisamide was well tolerated and efficacious over a period of at least 1year in children with partial epilepsy , with no unexpected safety concerns and no consistent detrimental effects on growth and development .
CONCLUSIONS	A PowerPoint slide summarizing this article is available for download in the Supporting Information section here .

###26080338
OBJECTIVE	An increasing amount of evidence supports the use of antibiotics instead of surgery for treating patients with uncomplicated acute appendicitis .
OBJECTIVE	To compare antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis confirmed by computed tomography ( CT ) .
METHODS	The Appendicitis Acuta ( APPAC ) multicenter , open-label , noninferiority randomized clinical trial was conducted from November 2009 until June 2012 in Finland .
METHODS	The trial enrolled 530 patients aged 18 to 60 years with uncomplicated acute appendicitis confirmed by a CT scan .
METHODS	Patients were randomly assigned to early appendectomy or antibiotic treatment with a 1-year follow-up period .
METHODS	Patients randomized to antibiotic therapy received intravenous ertapenem ( 1 g/d ) for 3 days followed by 7 days of oral levofloxacin ( 500 mg once daily ) and metronidazole ( 500 mg 3 times per day ) .
METHODS	Patients randomized to the surgical treatment group were assigned to undergo standard open appendectomy .
METHODS	The primary end point for the surgical intervention was the successful completion of an appendectomy .
METHODS	The primary end point for antibiotic-treated patients was discharge from the hospital without the need for surgery and no recurrent appendicitis during a 1-year follow-up period .
RESULTS	There were 273 patients in the surgical group and 257 in the antibiotic group .
RESULTS	Of 273 patients in the surgical group , all but 1 underwent successful appendectomy , resulting in a success rate of 99.6 % ( 95 % CI , 98.0 % to 100.0 % ) .
RESULTS	In the antibiotic group , 70 patients ( 27.3 % ; 95 % CI , 22.0 % to 33.2 % ) underwent appendectomy within 1 year of initial presentation for appendicitis .
RESULTS	Of the 256 patients available for follow-up in the antibiotic group , 186 ( 72.7 % ; 95 % CI , 66.8 % to 78.0 % ) did not require surgery .
RESULTS	The intention-to-treat analysis yielded a difference in treatment efficacy between groups of -27.0 % ( 95 % CI , -31.6 % to ) ( P = .89 ) .
RESULTS	Given the prespecified noninferiority margin of 24 % , we were unable to demonstrate noninferiority of antibiotic treatment relative to surgery .
RESULTS	Of the 70 patients randomized to antibiotic treatment who subsequently underwent appendectomy , 58 ( 82.9 % ; 95 % CI , 72.0 % to 90.8 % ) had uncomplicated appendicitis , 7 ( 10.0 % ; 95 % CI , 4.1 % to 19.5 % ) had complicated acute appendicitis , and 5 ( 7.1 % ; 95 % CI , 2.4 % to 15.9 % ) did not have appendicitis but received appendectomy for suspected recurrence .
RESULTS	There were no intra-abdominal abscesses or other major complications associated with delayed appendectomy in patients randomized to antibiotic treatment .
CONCLUSIONS	Among patients with CT-proven , uncomplicated appendicitis , antibiotic treatment did not meet the prespecified criterion for noninferiority compared with appendectomy .
CONCLUSIONS	Most patients randomized to antibiotic treatment for uncomplicated appendicitis did not require appendectomy during the 1-year follow-up period , and those who required appendectomy did not experience significant complications .
BACKGROUND	clinicaltrials.gov Identifier : NCT01022567 .

###24867298
OBJECTIVE	Safety and efficacy of a once daily controlled-released ( CR ) formulation of pregabalin was evaluated in patients with fibromyalgia using a placebo-controlled , randomized withdrawal design .
METHODS	This multicenter study included 6 week single-blind pregabalin CR treatment followed by 13 week double-blind treatment with placebo or pregabalin CR .
METHODS	The starting dose of 165mg/day was escalated during the first 3 weeks , up to 495mg/day based on efficacy and tolerability .
METHODS	Patients with 50 % reduction in average daily pain score at the end of the single-blind phase were randomized to continue pregabalin CR at the optimized dose ( 330-495mg / day ) or to placebo .
METHODS	The primary endpoint was time to loss of therapeutic response ( LTR ) , defined as < 30 % pain reduction relative to single-blind baseline or discontinuation owing to lack of efficacy or adverse event ( AE ) .
METHODS	Secondary endpoints included measures of pain severity , global assessment , functional status , tiredness/fatigue , and sleep .
BACKGROUND	ClinicalTrials.gov NCT01271933 .
RESULTS	A total of 441 patients entered the single-blind phase , and 63 were randomized to pregabalin CR and 58 to placebo .
RESULTS	The median time to LTR ( Kaplan-Meier analysis ) was significantly longer in the pregabalin CR group than placebo ( 58 vs. 22 days , p = 0.02 ) .
RESULTS	By trial end , 34/63 ( 54.0 % ) pregabalin CR and 41/58 ( 70.7 % ) placebo patients experienced LTR .
RESULTS	Significantly more patients reported ` benefit from treatment ' ( Benefit , Satisfaction , and Willingness to Continue Scale ) in the pregabalin CR group ; no other secondary endpoints were statistically significant .
RESULTS	Most AEs were mild to moderate in severity ( most frequent : dizziness , somnolence ) .
RESULTS	The percentage of pregabalin CR patients discontinuing because of AEs was 12.2 % and 4.8 % in the single-blind and double-blind phases , respectively ( placebo , 0 % ) .
CONCLUSIONS	Time to LTR was significantly longer with pregabalin CR versus placebo in fibromyalgia patients who initially showed improvement with pregabalin CR , indicating maintenance of response .
CONCLUSIONS	Pregabalin CR was well tolerated in most patients .
CONCLUSIONS	Generalizability may be limited by study duration and selective population .

###24644195
BACKGROUND	A key component of palliative care is support for family caregivers .
BACKGROUND	Although some family caregivers identify positive aspects , the impact is typically burdensome ; they are prone to physical and psychological morbidity , financial disadvantage and social isolation .
BACKGROUND	Outcomes of systematic reviews have highlighted the importance of investment in family caregiver intervention research .
OBJECTIVE	To provide an overview of the development , evaluation and outcomes arising from of a programme of research ( The Melbourne Family Support Program ( FSP ) ) , which focused on reducing the psychosocial burden of family caregivers .
METHODS	Developmental work involved a systematic literature review ; focus groups with family caregivers and health professionals ; and identification of a conceptual framework .
METHODS	Following a pilot randomised controlled trial ( RCT ) , a programme of psychoeducational intervention studies was developed and tested ; one via RCT , the others via prepost test .
RESULTS	Four psychoeducational interventions , incorporating one-to-one and group format delivery , conducted in both the home and inpatient hospital/hospice were evaluated .
RESULTS	Statistically significant outcomes included improvements in family caregivers ' preparedness , competence , positive emotions , more favourable levels of psychological wellbeing and a reduction in unmet needs .
RESULTS	Internationally endorsed guidelines for the psychosocial support of family caregivers were produced and several resources were constructed .
RESULTS	Fifteen publications in international peer-reviewed journals have arisen from this programme .
CONCLUSIONS	The interventions and resources from the Melbourne FSP provide several evidenced-based and clinically relevant approaches that focus on reducing the psychosocial burden of the caregiving role .
CONCLUSIONS	In several instances , however , more rigorous methodological testing is advocated .

###25183340
OBJECTIVE	The authors prospectively compared single dose ( 0.1 mmol/kg bodyweight ) gadobenate dimeglumine with double dose ( 0.2 mmol/kg bodyweight ) gadopentetate dimeglumine for contrast-enhanced magnetic resonance angiography ( CE-MRA ) in patients with suspected or known steno-occlusive disease of the carotid , renal or peripheral vasculature using an intra-individual crossover study design .
METHODS	Twenty-eight patients with suspected or known steno-occlusive disease of the carotid ( n = 16 ) , renal ( n = 5 ) or peripheral arteries ( n = 7 ) were randomised to receive either 0.1 mmol/kg gadobenate dimeglumine or 0.2 mmol/kg gadopentetate dimeglumine for a first CE-MRA procedure .
METHODS	After 3-5 days all patients underwent a second identical CE-MRA procedure with the other contrast agent .
METHODS	Three blinded readers assessed images for vessel anatomical delineation , disease detection/exclusion , and global preference .
METHODS	Diagnostic performance for detection of 51 % stenosis was determined for 20/28 patients who also underwent digital subtraction angiography ( DSA ) .
METHODS	Non-inferiority was assessed using the Wilcoxon signed rank , McNemar and Wald tests .
METHODS	Quantitative ( signal-to-noise and contrast-to-noise ratio ) enhancement based on 3D maximum intensity projection reconstructions was compared .
RESULTS	No differences were noted for any qualitative parameter .
RESULTS	Equivalence was reported for all diagnostic preference end-points .
RESULTS	Superiority for gadobenate dimeglumine was reported by all readers for sensitivity for disease detection ( 80.8-86 .5 vs. 75.0-82 .7 % ) .
RESULTS	Quantitative enhancement was similar for single dose gadobenate dimeglumine and double dose gadopentetate dimeglumine .
CONCLUSIONS	Under identical examination conditions a single 0.1 mmol/kg body weight dose of gadobenate dimeglumine can fully replace a double 0.2 mmol/kg body weight dose of gadopentetate dimeglumine for routine CE-MRA procedures .

###25132282
BACKGROUND	As a result of increased resistance to antibiotics , Helicobacter pylori eradication rates using standard triple therapy have been declining .
OBJECTIVE	To validate the efficacy and tolerability of a concomitant regimen as a first-line treatment for H. pylori infection .
METHODS	A total of 348 nave H. pylori-infected patients from six hospitals in Korea were randomly assigned to concomitant therapy and standard triple therapy groups .
METHODS	The concomitant regimen consisted of 30 mg of lansoprazole , 1g of amoxicillin , 500 mg of clarithromycin , and 500 mg of metronidazole , twice daily for 10 days .
METHODS	The standard triple regimen consisted of 30 mg of lansoprazole , 1g of amoxicillin , and 500 mg of clarithromycin , twice daily for 10 days .
RESULTS	Concomitant and standard eradication rates were 78.7 % ( 137/174 ) vs. 70.7 % ( 123/174 ) by intention-to-treat ( p = 0.084 ) and 88.7 % ( 133/150 ) vs. 78.4 % ( 120/153 ) by per-protocol ( p = 0.016 ) , respectively .
RESULTS	The two groups were similar with regard to the incidence of adverse events .
CONCLUSIONS	Although 10-day concomitant therapy was validated as a suboptimal treatment option for the treatment of H. pylori infection , this regimen is expected to be a promising starting point in the development of an optimal treatment regimen for H. pylori infection .

###24907494
OBJECTIVE	Eosinophilic esophagitis is usually triggered by foods , by unclear mechanisms .
OBJECTIVE	We evaluated the roles of IgE and IgG4 in the development of eosinophilic esophagitis .
METHODS	We performed a prospective , randomized , double-blind , placebo-controlled trial of adults with eosinophilic esophagitis given an antibody against IgE ( omalizumab , n = 16 ) or placebo ( n = 14 ) every 2-4 weeks for 16 weeks , based on weight and serum level of IgE .
METHODS	Endoscopy was performed , esophageal biopsy specimens were collected , and symptoms were assessed at baseline and at 16 weeks .
METHODS	Maximum numbers of eosinophils/high-power field were determined .
METHODS	Homogenates of esophageal biopsy specimens from 11 subjects with eosinophilic esophagitis and 8 without ( controls ) were assessed for IgM , IgA , and IgG subclasses .
METHODS	In a retrospective analysis , we performed immunofluorescence analysis of IgG4 in fixed esophageal tissues from 2 patients with eosinophilic esophagitis who underwent esophagectomy and 47 consecutive autopsies ( controls ) .
METHODS	We also performed immunofluorescence analysis of IgG4 in esophageal mucosal biopsy specimens from 24 subjects with eosinophilic esophagitis and 9 without ( controls ) .
METHODS	Finally , sera were collected from 15 subjects with eosinophilic esophagitis and from 41 without ( controls ) , and assayed for total and food-reactive IgG4 .
RESULTS	Omalizumab did not alter symptoms of eosinophilic esophagitis or eosinophil counts in biopsy samples compared with placebo .
RESULTS	Homogenates of esophageal tissues from patients with eosinophilic esophagitis had a 45-fold increase in IgG4 compared with controls ( P < 3 10 ( -5 ) ) , but no significant increases in other IgG subclasses , IgM , or IgA .
RESULTS	Sparse stromal deposits resembling immune complexes were found in 2 of 5 eosinophilic esophagitis biopsy specimens based on ultrastructural analysis .
RESULTS	Esophagectomy samples from 2 patients with eosinophilic esophagitis contained 180 and 300 IgG4 plasma cells/maximal high-power field , mainly in the deep lamina propria ; these levels were greater than in tissues from controls .
RESULTS	Fibrosis essentially was exclusive to the lamina propria .
RESULTS	Granular extracellular IgG4 was detected in biopsy specimens from 21 of 24 patients with eosinophilic esophagitis , butin none of the specimens from 9 controls ( P = 6 10 ( -6 ) ) .
RESULTS	The total serum level of IgG4 increased only slightly in patients with eosinophilic esophagitis , compared with controls .
RESULTS	Subjects witheosinophilic esophagitis had increased serum levels of IgG4 that reacted with milk , wheat , egg , and nuts-the 4 foods thatmost commonly trigger this condition ( P 3 10 ( -4 ) for each food ) .
CONCLUSIONS	In a prospective trial , omalizumab did not reduce symptoms of eosinophilic esophagitis or tissue eosinophil counts compared with placebo .
CONCLUSIONS	This finding , along with observed granular deposits of IgG4 , abundant IgG4-containing plasma cells , and serum levels of IgG4 reactive to specific foods , indicate that , in adults , eosinophilic esophagitis is IgG4-associated , and not an IgE-induced allergy .
CONCLUSIONS	ClinicalTrials.gov number : NCT00123630 .

###24347774
OBJECTIVE	The aim of this study is to compare the efficacy , safety and cost-effectiveness of topical Whitfield 's ointment plus oral fluconazole with topical 1 % butenafine in tinea infections of the skin .
METHODS	Patients were randomly allocated to the two treatment groups and advised to apply either agent topically twice-a-day for 4 weeks on the lesions and fluconazole ( 150 mg ) was administered once a week for 4 weeks in the study group applying Whitfield 's ointment .
METHODS	Patients were followed-up at an interval of 10 days for clinical score and global evaluation response was assessed at baseline and during each follow-up .
RESULTS	Out of 120 patients enrolled in the study 103 completed the study .
RESULTS	Patients treated with Whitfield 's ointment and oral fluconazole reduced mean sign and symptom score from 8.81 0.82 to 0.18 0.59 while butenafine treated patients reduced it from 8.88 0.53 to 0.31 0.67 at the end of the treatment .
RESULTS	Nearly , 98 % patients were completely cleared of the lesion on the 3 ( rd ) follow-up with both treatments .
CONCLUSIONS	Whitfield 's ointment with oral fluconazole is as efficacious , safe and cost-effective as compared with 1 % butenafine in tinea infections of the skin .

###25223743
BACKGROUND	Sacral nerve stimulation ( SNS ) has been demonstrated to alleviate symptoms and improve quality of life in selected patients with irritable bowel syndrome ( IBS ) .
BACKGROUND	The mechanisms of action , however , remain unknown .
BACKGROUND	The aim of the study was to evaluate the effects of SNS on rectal sensitivity and biomechanical properties in patients with IBS .
METHODS	Twenty patients with diarrhea-predominant ( n = 11 ) or mixed ( n = 9 ) IBS were treated with SNS in a controlled , randomized crossover trial .
METHODS	They were randomized to either 1 month of SNS ( ON ) or placebo ( OFF ) with the opposite setting for the next month .
METHODS	Sensory and biomechanical parameters were assessed by multimodal rectal stimulation at the end of each period .
METHODS	IBS-specific symptoms were evaluated at baseline and at the end of each treatment period .
RESULTS	Cold stimuli were better tolerated in the ON period ( 19.9 C [ 0.6 ] ) compared to the OFF period ( 21.8 C [ 0.6 ] ; p = 0.03 ) .
RESULTS	Significantly lower cross-sectional areas were needed to elicit sensory responses in the ON period ( 1545 mm ( 2 ) [ 95 ] ) compared to the OFF period ( 1869 mm ( 2 ) [ 92 ] ; p = 0.015 ) .
RESULTS	The association between reduced sensory threshold and improvement of constipation was of borderline significance ( p = 0.05 ) .
RESULTS	Wall stiffness was significantly lower in the ON period ( 192 mmHg [ 10 ] ) compared to the OFF period ( 234 mmHg [ 10 ] ; p = 0.004 ) .
RESULTS	Reduced wall stiffness was significantly associated with improved overall GSRS-IBS symptom score ( p = 0.01 ) .
RESULTS	Reduced sensory threshold to stretch ( p = 0.02 ) and reduced wall stiffness ( p < 0.001 ) were predictors of the GSRS-IBS symptom score .
CONCLUSIONS	SNS for diarrhea-predominant and mixed IBS relaxes the rectal wall , while making it more sensitive to stretch and less sensitive to cold .
CONCLUSIONS	Reduced wall stiffness and increased sensitivity to stretch are associated with improved GSRS-IBS symptom score .

###24964886
BACKGROUND	Restoration of biomechanics is a major goal in THA .
BACKGROUND	Imageless navigation enables intraoperative control of leg length equalization and offset reconstruction .
BACKGROUND	However , the effect of navigation compared with intraoperative fluoroscopy is unclear .
OBJECTIVE	We asked whether intraoperative use of imageless navigation ( 1 ) improves the relative accuracy of leg length and global and femoral offset restoration ; ( 2 ) increases the absolute precision of leg length and global and femoral offset equalization ; and ( 3 ) reduces outliers in a reconstruction zone of 5 mm for leg length and global and femoral offset restoration compared with intraoperative fluoroscopy during minimally invasive ( MIS ) THA with the patient in a lateral decubitus position .
METHODS	In this prospective study a consecutive series of 125 patients were randomized to either navigation-guided or fluoroscopy-controlled THA using sealed , opaque envelopes .
METHODS	All patients received the same cementless prosthetic components through an anterolateral MIS approach while they were in a lateral decubitus position .
METHODS	Leg length , global or total offset ( representing the combination of femoral and acetabular offset ) , and femoral offset differences were restored using either navigation or fluoroscopy .
METHODS	Postoperatively , residual leg length and global and femoral offset discrepancies were analyzed on magnification-corrected radiographs of the pelvis by an independent and blinded examiner using digital planning software .
METHODS	Accuracy was defined as the relative postoperative difference between the surgically treated and the unaffected contralateral side for leg length and offset , respectively ; precision was defined as the absolute postoperative deviation of leg length and global and femoral offset regardless of lengthening or shortening of leg length and offset throughout the THA .
METHODS	All analyses were performed per intention-to-treat .
RESULTS	Analyzing the relative accuracy of leg length restoration we found a mean difference of 0.2 mm ( 95 % CI , -1.0 to +1.4 mm ; p = 0.729 ) between fluoroscopy and navigation , 0.2 mm ( 95 % CI , -0.9 to +1.3 mm ; p = 0.740 ) for global offset and 1.7 mm ( 95 % CI , +0.4 to +2.9 mm ; p = 0.008 ) for femoral offset .
RESULTS	For the absolute precision of leg length and global and femoral offset equalization , there was a mean difference of 1.7 0.3 mm ( p < 0.001 ) between fluoroscopy and navigation .
RESULTS	The biomechanical reconstruction with a residual leg length and global and femoral offset discrepancy less than 5 mm and less than 8 mm , respectively , succeeded in 93 % and 98 % , respectively , in the navigation group and in 54 % and 95 % , respectively , in the fluoroscopy group .
CONCLUSIONS	Intraoperative fluoroscopy and imageless navigation seem equivalent in accuracy and precision to reconstruct leg length and global and femoral offset during MIS THA with the patient in the lateral decubitus position .

###24606847
OBJECTIVE	Cardiac muscle perfusion , as determined by single-photon emission computed tomography ( SPECT ) , decreases after breast and/or chest wall ( BCW ) irradiation .
OBJECTIVE	The active breathing coordinator ( ABC ) enables radiation delivery when the BCW is farther from the heart , thereby decreasing cardiac exposure .
OBJECTIVE	We hypothesized that ABC would prevent radiation-induced cardiac toxicity and conducted a randomized controlled trial evaluating myocardial perfusion changes after radiation for left-sided breast cancer with or without ABC .
METHODS	Stages I to III left breast cancer patients requiring adjuvant radiation therapy ( XRT ) were randomized to ABC or No-ABC .
METHODS	Myocardial perfusion was evaluated by SPECT scans ( before and 6 months after BCW radiation ) using 2 methods : ( 1 ) fully automated quantitative polar mapping ; and ( 2 ) semiquantitative visual assessment .
METHODS	The left ventricle was divided into 20 segments for the polar map and 17 segments for the visual method .
METHODS	Segments were grouped by anatomical rings ( apical , mid , basal ) or by coronary artery distribution .
METHODS	For the visual method , 2 nuclear medicine physicians , blinded to treatment groups , scored each segment 's perfusion .
METHODS	Scores were analyzed with nonparametric tests and linear regression .
RESULTS	Between 2006 and 2010 , 57 patients were enrolled and 43 were available for analysis .
RESULTS	The cohorts were well matched .
RESULTS	The apical and left anterior descending coronary artery segments had significant decreases in perfusion on SPECT scans in both ABC and No-ABC cohorts .
RESULTS	In unadjusted and adjusted analyses , controlling for pretreatment perfusion score , age , and chemotherapy , ABC was not significantly associated with prevention of perfusion deficits .
CONCLUSIONS	In this randomized controlled trial , ABC does not appear to prevent radiation-induced cardiac perfusion deficits .

###24565712
BACKGROUND	Atopic asthma is characterized by Th2 cytokine-driven inflammation of the airway mucosa , which is signaled by the fraction of exhaled nitric oxide ( FENO ) .
OBJECTIVE	We tested whether an FENO-guided anti-inflammatory treatment algorithm could improve asthma-related quality of life and asthma symptom control , and reduce exacerbations in atopic asthmatics within primary care .
METHODS	Altogether , 187 patients with asthma and who were nonsmokers ( age range , 18-64 years ) with perennial allergy and who were on regular inhaled corticosteroid treatment were recruited at 17 primary health care centers , randomly assigned to 2 groups and followed up for 1 year .
METHODS	For the controls ( n = 88 ) , FENO measurement was blinded to both operator and patient , and anti-inflammatory treatment was adjusted according to usual care .
METHODS	In the active group ( n = 93 ) , treatment was adjusted according to FENO .
METHODS	Questionnaires on asthma-related quality of life ( Mini Asthma Quality of Life Questionnaire ) and asthma control ( Asthma Control Questionnaire ) were completed , and asthma events were noted .
RESULTS	The Asthma Control Questionnaire score change over 1 year improved significantly more in the FENO-guided group ( -0.17 [ interquartile range { IQR } , -0.67 to 0.17 ] vs 0 [ -0.33 to 0.50 ] ; P = .045 ) , whereas the Mini Asthma Quality of Life Questionnaire score did not ( 0.23 [ IQR , 0.07-0 .73 ] vs 0.07 [ IQR , -0.20 to 0.80 ] ; P = .197 ) .
RESULTS	The change in Asthma Control Questionnaire was clinically important in subpopulations with poor control at baseline ( P = .03 ) .
RESULTS	Furthermore , the exacerbation rate ( exacerbations/patient/y ) was reduced by almost 50 % in the FENO-guided group ( 0.22 [ CI , 0.14-0 .34 ] vs 0.41 [ CI , 0.29-0 .58 ] ; P = .024 ) .
RESULTS	Mean overall inhaled corticosteroid use was similar in both groups ( P = .95 ) .
CONCLUSIONS	Use of FENO to guide anti-inflammatory treatment within primary care significantly reduced the exacerbation rate and improved asthma symptom control without increasing overall inhaled corticosteroid use .

###24329816
OBJECTIVE	It is needed to evaluate the spreadability , coverage , and adhesion of facial base makeup products .
METHODS	Using the oscillation applicator or hand application , 20 volunteers spread the liquid foundation on their faces and forearms .
METHODS	To assess the spreadability , coverage , and adhesion , we analyzed digital images of volunteers ' faces to measure spreadability and coverage , and we measured the adhesion effect on the forearm by tape-stripping .
RESULTS	In terms of spreadability , coverage , and adhesion , the results of group who used the ` oscillation applicator ' were significantly twice as high as the other group who applied by hand .
CONCLUSIONS	In this study , we demonstrated a method for quantitative assessing the effect of spreadability , coverage , and adhesion of the liquid foundation used in base makeup .
CONCLUSIONS	Also , we discovered a distinction between using an oscillation applicator and using hand application .
CONCLUSIONS	It is expected that image analysis assessment and tape-stripping would be useful parameters for the evaluation of the facial base makeup .

###25007690
BACKGROUND	Epidural route is preferable for postoperative pain relief in thoraco-abdominal and lower limb surgeries .
BACKGROUND	We aimed to compare epidural butorphanol versus morphine for postoperative analgesia up to 24 hours in open nephrectomy surgery .
METHODS	80 ASA physical status I and II adult patients were selected for this randomized double blind prospective study .
METHODS	A standard balanced general anesthesia technique was applied for all patients .
METHODS	Epidural catheter was placed in lower thoracic inter-vertebral space before the start of surgery .
METHODS	Injection butorphanol 0.04 mg/kg in group B ( n = 40 ) or morphine 0.06 mg/kg in group M ( n = 40 ) was given in a double blind manner after completion of surgery and before extubation through the epidural catheter .
METHODS	Patients were observed for pain relief by Visual Analogue Scale ( VAS ) for the next 24 hours .
METHODS	Dose was repeated when VAS was > 4 .
METHODS	The onset and peak effect of pain relief , duration of analgesia of 1st dose , frequency of drug administration and side effects if any were observed .
RESULTS	The average onset of analgesia was 26.5 + / - 7.61 minutes with butorphanol and 62.5 + / - 13.4 minutes with morphine group which was statistically significant ( p < 0.05 ) .
RESULTS	The mean peak effect of pain relief following 1st dose was 173 + / - 51.25 minutes with butorphanol and 251 + / - 52.32 minutes with morphine group .
RESULTS	The duration of pain relief after 1st dose was statistically significant and was 339.13 + / - 79.57 minutes in group B and 709.75 + / - 72.12 minutes in group M which was gradually increased on repeated dosing in group B while it was almost same in Group M. Number of doses required in 24 hours was significantly higher ( p < 0.05 ) in butorphanol group than morphine group .
RESULTS	Somnolence was the main side effect in group B while pruritus was the main side effect with group M.
CONCLUSIONS	Epidural butorphanol appears to provide safer and faster postoperative analgesia without much untoward effects but its analgesic action is short so more repeated doses are required than morphine via epidural catheter up to 24 hours .

###24718886
BACKGROUND	The Panitumumab Randomized trial In combination with chemotherapy for Metastatic colorectal cancer to determine Efficacy ( PRIME ) demonstrated that panitumumab-FOLFOX4 significantly improved progression-free survival ( PFS ) versus FOLFOX4 as first-line treatment of wild-type ( WT ) KRAS metastatic colorectal cancer ( mCRC ) , the primary end point of the study .
METHODS	Patients were randomized 1:1 to panitumumab 6.0 mg/kg every 2 weeks + FOLFOX4 ( arm 1 ) or FOLFOX4 ( arm 2 ) .
METHODS	This prespecified final descriptive analysis of efficacy and safety was planned for 30 months after the last patient was enrolled .
RESULTS	A total of 1183 patients were randomized .
RESULTS	Median PFS for WT KRAS mCRC was 10.0 months [ 95 % confidence interval ( CI ) 9.3-11 .4 months ] for arm 1 and 8.6 months ( 95 % CI 7.5-9 .5 months ) for arm 2 ; hazard ratio ( HR ) = 0.80 ; 95 % CI 0.67-0 .95 ; P = 0.01 .
RESULTS	Median overall survival ( OS ) for WT KRAS mCRC was 23.9 months ( 95 % CI 20.3-27 .7 months ) for arm 1 and 19.7 months ( 95 % CI 17.6-22 .7 months ) for arm 2 ; HR = 0.88 ; 95 % CI 0.73-1 .06 ; P = 0.17 ( 68 % OS events ) .
RESULTS	An exploratory analysis of updated survival ( > 80 % OS events ) was carried out which demonstrated improvement in OS ; HR = 0.83 ; 95 % CI 0.70-0 .98 ; P = 0.03 for WT KRAS mCRC .
RESULTS	The adverse event profile was consistent with the primary analysis .
CONCLUSIONS	In WT KRAS mCRC , PFS was improved , objective response was higher , and there was a trend toward improved OS with panitumumab-FOLFOX4 , with significant improvement in OS observed in an updated analysis of survival in patients with WT KRAS mCRC treated with panitumumab + FOLFOX4 versus FOLFOX4 alone ( P = 0.03 ) .
CONCLUSIONS	These data support a positive benefit-risk profile for panitumumab-FOLFOX4 for patients with previously untreated WT KRAS mCRC .
CONCLUSIONS	KRAS testing is critical to select appropriate patients for treatment with panitumumab .

###25320185
BACKGROUND	Studies on protein requirements in vulnerable groups such as older adults are few , and results are conflicting .
OBJECTIVE	The main objective of this study was to determine the protein requirements of free-living women > 65 y by measuring the oxidation of l - [ 1 - ( 13 ) C ] phenylalanine to ( 13 ) CO2 in response to graded intakes of protein .
METHODS	Twelve subjects participated in the study , with protein intakes ranging from 0.2 to 2.0 g kg ( -1 ) d ( -1 ) for a total of 82 studies .
METHODS	The diets provided energy at 1.5 times each subject 's resting energy expenditure and were isocaloric .
METHODS	Protein was given as an amino acid mixture on the basis of the egg protein pattern , except for phenylalanine and tyrosine , which were maintained constant across the protein intake amounts .
METHODS	All subjects were adapted for 2 d before the study day to a protein intake of 1.0 g kg ( -1 ) d ( -1 ) .
METHODS	The mean protein requirement was determined by applying a mixed-effects change-point regression analysis to F ( 13 ) CO2 ( label tracer oxidation in ( 13 ) CO2 breath ) , which identified a breakpoint in the F ( 13 ) CO2 in response to graded amounts of protein .
RESULTS	The mean estimated average requirement ( EAR ) and upper 95 % CI ( approximating the RDA ) protein requirement of women > 65 y were 0.96 and 1.29 g kg ( -1 ) d ( -1 ) , respectively .
CONCLUSIONS	These estimates of protein requirements for older women are higher than the current EAR and RDA based on nitrogen balance data , which are 0.66 and 0.80 g kg ( -1 ) d ( -1 ) , respectively .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01604980 .

###25562462
OBJECTIVE	Initial medication response has been shown to predict treatment outcome across a variety of substance use disorders , but no studies have examined the predictive power of initial response to buprenorphine-naloxone in the treatment of prescription opioid dependence .
OBJECTIVE	We therefore conducted a secondary analysis of data from the Prescription Opioid Addiction Treatment Study to determine whether initial response to buprenorphine-naloxone predicted 12-week treatment outcome in a prescription opioid-dependent population .
METHODS	Using data from a multisite , randomized controlled trial of buprenorphine-naloxone plus counseling for DSM-IV prescription opioid dependence ( June 2006-July 2009 ) , we conducted a secondary analysis to investigate the relationship between initial medication response and 12-week treatment outcome to establish how soon the efficacy of buprenorphine-naloxone could be predicted ( N = 360 ) .
METHODS	Outcomes were determined from the Substance Use Report , a self-report measure of substance use , and confirmatory urinalysis .
METHODS	Predictive values were calculated to determine the importance of abstinence versus use at various time points within the first month of treatment ( week 1 , weeks 1-2 , 1-3 , or 1-4 ) in predicting successful versus unsuccessful treatment outcome ( based on abstinence or near-abstinence from opioids ) in the last 4 weeks of buprenorphine-naloxone treatment ( weeks 9-12 ) .
RESULTS	Outcome was best predicted by medication response after 2 weeks of treatment .
RESULTS	Two weeks of initial abstinence was moderately predictive of treatment success ( positive predictive value = 71 % ) , while opioid use in both of the first 2 weeks was strongly predictive of unsuccessful treatment outcome ( negative predictive value [ NPV ] = 84 % ) , especially when successful outcome was defined as total abstinence from opioids in weeks 9-12 ( NPV = 94 % ) .
CONCLUSIONS	Evaluating prescription opioid-dependent patients after 2 weeks of buprenorphine-naloxone treatment may help determine the likelihood of successful outcome at completion of the current treatment regimen .
BACKGROUND	ClinicalTrials.gov identifier : NCT00316277 .

###24461526
OBJECTIVE	To investigate whether there is an association between diameter of bacille Calmette-Gurin ( BCG ) scars and effect of purified protein derivative ( PPD ) reaction and to determine whether vitamin A ( VA ) combined vitamin D ( VD ) supplementation influences the immune response to BCG revaccinated in Chinese infants .
METHODS	A cross-section and 3-month community-randomised trial was conducted .
METHODS	A total of 5 629 infants at 3 , 6 and 12 months of age in Junan County of China were examined for BCG scar formation .
METHODS	Then , 597 revaccinated infants were randomly assigned to supplementation ( n = 307 ) and control ( n = 290 ) groups .
METHODS	The supplementation group were daily assigned to 1 500 IU VA and 500 IU VD for 3 months .
METHODS	Then all infants were subjected to skin test with PPD .
RESULTS	The diameter of BCG scars was positively correlated with diameter of skin indurations of PPD ( r = 0.17 , P < 0.05 ) in the 5 629 infants .
RESULTS	The rate of positive response to PPD was higher in the supplementation group than in the control group ( 96.1 % versus 89.7 % , P < 0.05 , prevalence ratio 1.07 , 95 % CI 1.02-1 .12 ) .
RESULTS	The prevalence ratio of PPD response for the supplementation group compared with that for the control group was 1.07 ( 95 % CI 1.01-1 .13 ) for the males and 1.08 ( 95 % CI 1.00-1 .17 ) for the females .
RESULTS	For the supplementation group , the males got larger tuberculin induration than the females [ ( 0.730.21 ) cm versus ( 0.670.20 ) cm , P < 0.05 ) after intervention .
CONCLUSIONS	The diameter of BCG scars was effectively correlated with PPD response , which indicates BCG scar formation may be an useful tool to evaluate the effect of tuberculosis prevention .
CONCLUSIONS	VA combined VD supplementation may play an immuno-regulatory role in BCG revaccination .
CONCLUSIONS	This may contribute to the prevention of childhood tuberculosis .

###24421408
BACKGROUND	Barbed sutures were developed to reduce operative time and improve security of wound closure .
OBJECTIVE	The authors compare absorbable barbed sutures ( V-Loc , Covidien , Mansfield , Massachusetts ) with conventional ( smooth ) absorbable sutures for soft tissue approximation .
METHODS	A prospective multicenter randomized study comparing barbed sutures with smooth sutures was undertaken between August 13 , 2009 , and January 31 , 2010 , in 241 patients undergoing abdominoplasty , mastopexy , and reduction mammaplasty .
METHODS	Each patient received barbed sutures on 1 side of the body , with deep dermal sutures eliminated or reduced .
METHODS	Smooth sutures with deep dermal and subcuticular closure were used on the other side as a control .
METHODS	The primary endpoint was dermal closure time .
METHODS	Safety was assessed through adverse event reporting through a 12-week follow-up .
RESULTS	A total of 229 patients were ultimately treated ( 115 with slow-absorbing polymer and 114 with rapid-absorbing polymer ) .
RESULTS	Mean dermal closure time was significantly quicker with the barbed suture compared with the smooth suture ( 12.0 vs 19.2 minutes ; P < .001 ) , primarily due to the need for fewer deep dermal sutures .
RESULTS	The rapid-absorbing barbed suture showed a complication profile equivalent to the smooth suture , while the slow-absorbing barbed suture had a higher incidence of minor suture extrusion .
CONCLUSIONS	Barbed sutures enabled faster dermal closure quicker than smooth sutures , with a comparable complication profile .
METHODS	1 .

###26158605
BACKGROUND	Low T levels have been associated with ejaculatory dysfunction ( EjD ) in cross-sectional studies ; however , the efficacy of T replacement in improving EjD has not been studied in a randomized controlled trial .
OBJECTIVE	To evaluate the efficacy of T replacement in androgen-deficient men with EjD .
METHODS	A multicenter , double-blind , randomized , placebo-controlled , 16-week trial with T solution 2 % versus placebo .
METHODS	Medical centers in the United States , Canada , and Mexico .
METHODS	Seventy-six men with one or more EjD symptoms , including delayed ejaculation , anejaculation , reduced ejaculate volume , and/or reduced force of ejaculation , and two total T levels < 300 ng/dL ( < 10.41 nmol/L ) measured with liquid chromatography tandem mass spectrometry .
METHODS	Sixty milligrams of T solution 2 % or placebo applied to the axillae for 16 weeks .
METHODS	The primary outcome was a change in the score of the three-item Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form ( MSHQ-EjD-SF ) ; secondary outcomes included measured ejaculate volume , scores of the bother/satisfaction item of the MSHQ-EjD-SF , the orgasmic function domain of the International Index of Erectile Function Questionnaire , and the sexual activity log .
RESULTS	Seventy-six participants were randomized ; 66 completed the study .
RESULTS	Baseline demographic and clinical characteristics were comparable between the treatment arms .
RESULTS	T replacement improved the MSHQ-EjD-SF score ( mean score change , +3.1 ) ; however , this effect was not statistically different from placebo ( mean score change , +2.5 ; P = .596 ) .
RESULTS	No differences were seen in any of the secondary outcomes or frequency of adverse events .
CONCLUSIONS	T replacement was not associated with significant improvement in EjD in androgen-deficient men .

###24372795
OBJECTIVE	To evaluate the effectiveness of an accessibility-enhanced multimedia informational educational programme in reducing anxiety and increasing satisfaction with the information and materials received by patients undergoing cardiac catheterisation .
BACKGROUND	Cardiac catheterisation is one of the most anxiety-provoking invasive procedures for patients .
BACKGROUND	However , informational education using multimedia to inform patients undergoing cardiac catheterisation has not been extensively explored .
METHODS	A randomised experimental design with three-cohort prospective comparisons .
METHODS	In total , 123 consecutive patients were randomly assigned to one of three groups : regular education ; ( group 1 ) , accessibility-enhanced multimedia informational education ( group 2 ) and instructional digital videodisc education ( group 3 ) .
METHODS	Anxiety was measured with Spielberger 's State Anxiety Inventory , which was administered at four time intervals : before education ( T0 ) , immediately after education ( T1 ) , before cardiac catheterisation ( T2 ) and one day after cardiac catheterisation ( T3 ) .
METHODS	A satisfaction questionnaire was administrated one day after cardiac catheterisation .
METHODS	Data were collected from May 2009-September 2010 and analysed using descriptive statistics , chi-squared tests , one-way analysis of variance , Scheffe 's post hoc test and generalised estimating equations .
RESULTS	All patients experienced moderate anxiety at T0 to low anxiety at T3 .
RESULTS	Accessibility-enhanced multimedia informational education patients had significantly lower anxiety levels and felt the most satisfied with the information and materials received compared with patients in groups 1 and 3 .
RESULTS	A statistically significant difference in anxiety levels was only found at T2 among the three groups ( p = 0004 ) .
CONCLUSIONS	The findings demonstrate that the accessibility-enhanced multimedia informational education was the most effective informational educational module for informing patients about their upcoming cardiac catheterisation , to reduce anxiety and improve satisfaction with the information and materials received compared with the regular education and instructional digital videodisc education .
CONCLUSIONS	As the accessibility-enhanced multimedia informational education reduced patient anxiety and improved satisfaction with the information and materials received , it can be adapted to complement patient education in future regular cardiac care .

###24835495
OBJECTIVE	The present study addressed the question whether neurophysiological signals exhibit characteristic modulations preceding a miss in a covert vigilant attention task which mimics a natural environment in which critical stimuli may appear in the periphery of the visual field .
METHODS	Subjective , behavioural and encephalographic ( EEG ) data of 12 participants performing a modified Mackworth Clock task were obtained and analysed offline .
METHODS	The stimulus consisted of a pointer performing regular ticks in a clockwise sequence across 42 dots arranged in a circle .
METHODS	Participants were requested to covertly attend to the pointer and press a response button as quickly as possible in the event of a jump , a rare and random event .
RESULTS	Significant increases in response latencies and decreases in the detection rates were found as a function of time-on-task , a characteristic effect of sustained attention tasks known as the vigilance decrement .
RESULTS	Subjective sleepiness showed a significant increase over the duration of the experiment .
RESULTS	Increased activity in the - frequency range ( 8-14 Hz ) was observed emerging and gradually accumulating 10 s before a missed target .
RESULTS	Additionally , a significant gradual attenuation of the P3 event-related component was found to antecede misses by 5 s.
CONCLUSIONS	The results corroborate recent findings that behavioural errors are presaged by specific neurophysiological activity and demonstrate that lapses of attention can be predicted in a covert setting up to 10 s in advance reinforcing the prospective use of brain-computer interface ( BCI ) technology for the detection of waning vigilance in real-world scenarios .
CONCLUSIONS	Combining these findings with real-time single-trial analysis from BCI may pave the way for cognitive states monitoring systems able to determine the current , and predict the near-future development of the brain 's attentional processes .

###25946708
BACKGROUND	A better understanding of drivers of treatment costs may help identify effective cost containment strategies and prioritize resources .
BACKGROUND	We aimed to develop a method for estimating inpatient costs for pediatric patients with acute myeloid leukemia ( AML ) enrolled on NCI-funded Phase III trials , compare costs between AAML0531 treatment arms ( standard chemotherapy gemtuzumab ozogamicin ( GMTZ ) ) , and evaluate primary drivers of costs for newly diagnosed pediatric AML .
METHODS	Patients from the AAML0531 trial were matched on hospital , sex , and dates of birth and diagnosis to the Pediatric Health Information Systems ( PHIS ) database to obtain daily billing data .
METHODS	Inpatient treatment costs were calculated as adjusted charges multiplied by hospital-specific cost-to-charge ratios .
METHODS	Generalized linear models were used to compare costs between treatment arms and courses , and by patient characteristics .
RESULTS	Inpatient costs did not differ by randomized treatment arm .
RESULTS	Costs varied by course with stem cell transplant being most expensive , followed by Intensification II ( cytarabine/mitoxantrone ) and Induction I ( cytarabine/daunorubicin/etoposide ) .
RESULTS	Room/board and pharmacy were the largest contributors to inpatient treatment cost , representing 74 % of the total cost .
RESULTS	Higher AML risk group ( P = 0.0003 ) and older age ( P < 0.0001 ) were associated with significantly higher daily inpatient cost .
CONCLUSIONS	Costs from external data sources can be successfully integrated into NCI-funded Phase III clinical trials .
CONCLUSIONS	Inpatient treatment costs did not differ by GMTZ exposure but varied by chemotherapy course .
CONCLUSIONS	Variation in cost by course was driven by differences in duration of hospitalization through room/board charges as well as increased clinical and pharmacy charges in specific courses .

###25701295
OBJECTIVE	The Institute of Medicine has called on the US health care system to identify and reduce medical errors .
OBJECTIVE	Unfortunately , medication dosing errors remain commonplace and may result in potentially life-threatening outcomes , particularly for pediatric patients when dosing requires weight-based calculations .
OBJECTIVE	Novel medication delivery systems that may reduce dosing errors resonate with national health care priorities .
OBJECTIVE	Our goal was to evaluate novel , prefilled medication syringes labeled with color-coded volumes corresponding to the weight-based dosing of the Broselow Tape , compared with conventional medication administration , in simulated pediatric emergency department ( ED ) resuscitation scenarios .
METHODS	We performed a prospective , block-randomized , crossover study in which 10 emergency physician and nurse teams managed 2 simulated pediatric arrest scenarios in situ , using either prefilled , color-coded syringes ( intervention ) or conventional drug administration methods ( control ) .
METHODS	The ED resuscitation room and the intravenous medication port were video recorded during the simulations .
METHODS	Data were extracted from video review by blinded , independent reviewers .
RESULTS	Median time to delivery of all doses for the conventional and color-coded delivery groups was 47 seconds ( 95 % confidence interval [ CI ] 40 to 53 seconds ) and 19 seconds ( 95 % CI 18 to 20 seconds ) , respectively ( difference = 27 seconds ; 95 % CI 21 to 33 seconds ) .
RESULTS	With the conventional method , 118 doses were administered , with 20 critical dosing errors ( 17 % ) ; with the color-coded method , 123 doses were administered , with 0 critical dosing errors ( difference = 17 % ; 95 % CI 4 % to 30 % ) .
CONCLUSIONS	A novel color-coded , prefilled syringe decreased time to medication administration and significantly reduced critical dosing errors by emergency physician and nurse teams during simulated pediatric ED resuscitations .

###25770987
OBJECTIVE	Prosthetic grafts continue to be required for hemodialysis access when the options for native fistulas have been exhausted .
OBJECTIVE	The inferior long-term patency of grafts makes the possibility of preventing occlusion with heparin-bonded grafts an attractive alternative .
OBJECTIVE	We carried out a prospective randomized study to compare the patency of standard grafts with heparin-bonded grafts .
METHODS	Patients with end-stage renal failure requiring a prosthetic access were randomized to receive either a standard expanded polytetrafluorethylene ( ePTFE ) graft or a heparin-bonded ePTFE graft .
METHODS	Patients were enrolled from June 2007 until November 2011 and were followed up until July 2013 , when the study concluded .
RESULTS	In this study , 160 patients were randomized and followed up for a median of 23.5 months .
RESULTS	No patient was lost to follow-up .
RESULTS	Primary patency was 35 % and 14 % for heparin-bonded grafts and 29 % and 12 % for standard ePTFE grafts at 6 and 12 months , respectively ( P = .48 ) .
RESULTS	Assisted primary patency was 54 % , 41 % , and 27 % for heparin-bonded grafts and 41 % , 30 % , and 23 % for standard grafts at 12 , 24 , and 36 months , respectively ( P = .12 ) .
RESULTS	Secondary patency was 83 % , 83 % , and 81 % for heparin-bonded grafts and 81 % , 73 % , and 68 % for standard grafts at 12 , 24 , and 36 months , respectively ( P = .33 ) .
RESULTS	There were significantly fewer thromboses in heparin-bonded grafts during the first 5 months ( P = .020 ) .
RESULTS	Of 80 standard grafts , 24 were eventually abandoned vs 17 heparin-bonded grafts ( P = .188 ) .
RESULTS	Bleeding complications , infections , and intervention rates were similar in both groups .
CONCLUSIONS	Heparin-bonded grafts demonstrated a trend to improved patency , but the difference was not statistically significant .
CONCLUSIONS	Heparin-bonded grafts had a significantly lower early thrombosis rate that was sustained only for the first 5 months of follow-up .

###24551029
BACKGROUND	Cellulitis ( erysipelas ) is a recurring and debilitating bacterial infection of the skin and underlying tissue .
BACKGROUND	We assessed the cost-effectiveness of prophylactic antibiotic treatment to prevent the recurrence of cellulitis using low dose penicillin V in patients following a first episode ( 6 months prophylaxis ) and more recurrent cellulitis ( 12 months prophylaxis , or 6 months in those declining 12 months ) .
METHODS	Within-trial cost-effectiveness analysis was conducted using the findings of two randomised placebo-controlled multicentre trials ( PATCH I and PATCH II ) , in which patients recruited in the UK and Ireland were followed-up for up to 3 years .
METHODS	Incremental cost , reduction in recurrence , cost per recurrence prevented and cost/QALY were estimated .
METHODS	National unit and reference costs for England in 2010 were applied to resource use , exploring NHS and societal perspectives .
METHODS	A total of 397 patients from the two trials contributed to the analysis .
RESULTS	There was a 29 % reduction in the number of recurrences occurring within the trial ( IRR : 0.71 95 % CI : 0.53 to 0.90 , p = 0.02 ) , corresponding to an absolute reduction of recurrence of 0.31 recurrences/patient ( 95 % CI : 0.05 to 0.59 , p = 0.02 ) .
RESULTS	Incremental costs of prophylaxis suggested a small cost saving but were not statistically significant , comparing the two groups .
RESULTS	If a decision-maker is willing to pay up to 25,000 / QALY then there is a 66 % probability of antibiotic prophylaxis being cost-effective from an NHS perspective , rising to 76 % probability from a secondary , societal perspective .
CONCLUSIONS	Following first episode or recurrent cellulitis of the leg , prophylactic low dose penicillin is a very low cost intervention which , on balance , is effective and cost-effective at preventing subsequent attacks .
CONCLUSIONS	Antibiotic prophylaxis reduces cellulitis recurrence by nearly a third but is not associated with a significant increase in costs .

###24973083
OBJECTIVE	Cardiac rehabilitation ( CR ) is pivotal in preventing recurring events of myocardial infarction ( MI ) .
OBJECTIVE	This study aims to investigate the effect of a smartphone-based home service delivery ( Care Assessment Platform ) of CR ( CAP-CR ) on CR use and health outcomes compared with a traditional , centre-based programme ( TCR ) in post-MI patients .
METHODS	In this unblinded randomised controlled trial , post-MI patients were randomised to TCR ( n = 60 ; 55.710.4 years ) and CAP-CR ( n = 60 ; 55.59.6 years ) for a 6-week CR and 6-month self-maintenance period .
METHODS	CAP-CR , delivered in participants ' homes , included health and exercise monitoring , motivational and educational material delivery , and weekly mentoring consultations .
METHODS	CAP-CR uptake , adherence and completion rates were compared with TCR using intention-to-treat analyses .
METHODS	Changes in clinical outcomes ( modifiable lifestyle factors , biomedical risk factors and health-related quality of life ) across baseline , 6weeks and 6months were compared within , and between , groups using linear mixed model regression .
RESULTS	CAP-CR had significantly higher uptake ( 80 % vs 62 % ) , adherence ( 94 % vs 68 % ) and completion ( 80 % vs 47 % ) rates than TCR ( p < 0.05 ) .
RESULTS	Both groups showed significant improvements in 6-minute walk test from baseline to 6weeks ( TCR : 53786-58499m ; CAP-CR : 51077-57080m ) , which was maintained at 6months .
RESULTS	CAP-CR showed slight weight reduction ( 8920-8821kg ) and also demonstrated significant improvements in emotional state ( K10 : median ( IQR ) 14.6 ( 13.4-16 .0 ) to 12.6 ( 11.5-13 .8 ) ) , and quality of life ( EQ5D-Index : median ( IQR ) 0.84 ( 0.8-0 .9 ) to 0.92 ( 0.9-1 .0 ) ) at 6weeks .
CONCLUSIONS	This smartphone-based home care CR programme improved post-MI CR uptake , adherence and completion .
CONCLUSIONS	The home-based CR programme was as effective in improving physiological and psychological health outcomes as traditional CR .
CONCLUSIONS	CAP-CR is a viable option towards optimising use of CR services .
BACKGROUND	ANZCTR12609000251224 .

###25112086
OBJECTIVE	To compare the clinical efficacy differences between fire needling technique of filiform needle at high stress points and regular acupuncture on chrondromalacia patellae so as to provide the better therapy for the treatment of this disease .
METHODS	Sixty cases of chrondromalacia patellae were randomized into a fire needling group ( 28 cases ) and a routine acupuncture group ( 32 cases ) .
METHODS	In the fire needling group , 5 to 6 high stress points were localized according to the symptoms , palpation and imaging condition and were stimulated with fire needling technique of filiform needle .
METHODS	The treatment was given once every two days , 5 treatments made one session .
METHODS	In the routine acupuncture group , the regular acupuncture was applied at Dubi ( ST 35 ) , Xiguan ( LR 7 ) , Yanglingquan ( GB 34 ) , Yinlingquan ( SP 9 ) , Zusanli ( ST 36 ) , etc. .
METHODS	The treatment was given once every day , 5 treatments made one session .
METHODS	Lysholm score , VSA score , patella title angle ( PTA ) and lateral patella angle ( LPA ) of the affected knees before and after treatment , as well as the clinical efficacy after treatment were observed in the two groups .
RESULTS	After treatment , Lysholm score , VSA score , PTA and LPA were all improved apparently in the two groups ( all P < 0.01 ) .
RESULTS	After the treatments , the improvements in Lysholm score , VSA score , PTA and LPA in the fire needling group were more obvious than those in the routine acupuncture group ( all P < 0.05 ) .
RESULTS	The effective rate was 92.9 % ( 26/28 ) in the fire needling group , better than 87.5 % ( 28/32 ) in the routine acupuncture group ( P < 0.01 ) .
CONCLUSIONS	The fire needling technique of filiform needle at the high stress points relieves the clinical symptoms of chrondromalacia patellae and recovers the biodynamical structure of patellae .

###24637559
BACKGROUND	The double-blind , placebo-controlled Sildenafil in Treatment-Naive Children , Aged 1 to 17 Years , With Pulmonary Arterial Hypertension ( STARTS-1 ) study assessed sildenafil in pediatric patients with pulmonary arterial hypertension ; improved hemodynamics and exercise capacity occurred in medium - and high-dose groups .
BACKGROUND	STARTS-2 was the extension study .
RESULTS	In STARTS-1 , 234 children 8 kg were randomly assigned to low - , medium - , or high-dose sildenafil or placebo orally thrice daily ; within-group dose depended on weight .
RESULTS	In STARTS-2 , sildenafil-treated patients continued STARTS-1 dosing ; placebo-treated patients were randomized to 1 of the 3 sildenafil dose groups .
RESULTS	Patients requiring additional pulmonary arterial hypertension-specific therapy discontinued study treatment ; survival follow-up was attempted .
RESULTS	As of August 2011 , all children received 3 years of treatment ( unless discontinued ) from STARTS-1 baseline ; 37 deaths were reported ( 26 on study treatment ) , 1 of which occurred within the first year of treatment .
RESULTS	Most patients who died ( 28/37 ) had idiopathic/heritable pulmonary arterial hypertension ( 76 % versus 33 % overall ) and baseline functional class III/IV disease ( 38 % versus 15 % overall ) ; patients who died had worse baseline hemodynamics .
RESULTS	Kaplan-Meier estimated 3-year survival rates from start of sildenafil were 94 % , 93 % , and 88 % for patients randomized to low - , medium - , and high-dose sildenafil , respectively ; 87 % , 89 % , and 80 % were known to be alive at 3 years .
RESULTS	Hazard ratios for mortality were 3.95 ( 95 % confidence interval , 1.46-10 .65 ) for high versus low and 1.92 ( 95 % confidence interval , 0.65-5 .65 ) for medium versus low dose ; however , multiple analyses raised uncertainty about the survival/dose relationship .
CONCLUSIONS	Although children randomized to higher compared with lower sildenafil doses had an unexplained increased mortality , all sildenafil dose groups displayed favorable survival for children with pulmonary arterial hypertension .
BACKGROUND	http://clinicaltrials.gov/ct2/show/NCT00159874 ( extension study of NCT00149913 ) .
BACKGROUND	Unique identifier : NCT00159874 .

###25344090
OBJECTIVE	Abiraterone acetate ( AA ) was recently approved for castration-resistant prostate cancer in Japan .
OBJECTIVE	Two phase 1 studies were conducted to assess the pharmacokinetics of abiraterone after single-dose administration in Japanese healthy men and to evaluate the effects of food timing on abiraterone pharmacokinetics after single-dose administration of AA in Japanese and Caucasian healthy men .
METHODS	In the dose-proportionality study , subjects ( n = 30 Japanese ) were randomly assigned to receive single doses of 250 , 500 , and 1,000 mg AA , and in the food-timing study , subjects ( n = 22 Japanese and n = 23 Caucasian ) randomly received single doses of 1,000 mg AA under fasted ( overnight ) and three different modified fasting conditions .
RESULTS	Mean C ( max ) and AUC ( ) for abiraterone increased dose-dependently in Japanese healthy men ; however , 90 % confidential interval ( CI ) was outside the predefined dose-proportionality criteria .
RESULTS	Based on geometric mean ratios and 90 % CIs ( versus overnight fasting condition ) , abiraterone exposure ( AUC ) increased significantly with dosing 1 h premeal , 2 h postmeal , or in between two meals 4 h apart by 57 % , 595 % , and 649 % , respectively .
CONCLUSIONS	No clinically meaningful difference was observed in the pharmacokinetics of abiraterone between Caucasian and Japanese subjects .

###24952693
OBJECTIVE	The aim of this study was to determine whether biomarkers of myocardial stress and fibrosis improve prediction of the mode of death in patients with chronic heart failure .
BACKGROUND	The 2 most common modes of death in patients with chronic heart failure are pump failure and sudden cardiac death .
BACKGROUND	Prediction of the mode of death may facilitate treatment decisions .
BACKGROUND	The relationship between amino-terminal pro-brain natriuretic peptide ( NT-proBNP ) , galectin-3 , and ST2 , biomarkers that reflect different pathogenic pathways in heart failure ( myocardial stress and fibrosis ) , and mode of death is unknown .
METHODS	HF-ACTION ( Heart Failure : A Controlled Trial Investigating Outcomes of Exercise Training ) was a randomized controlled trial of exercise training versus usual care in patients with chronic heart failure due to left ventricular systolic dysfunction ( left ventricular ejection fraction35 % ) .
METHODS	An independent clinical events committee prospectively adjudicated mode of death .
METHODS	NT-proBNP , galectin-3 , and ST2 levels were assessed at baseline in 813 subjects .
METHODS	Associations between biomarkers and mode of death were assessed using cause-specific Cox proportional hazards modeling , and interaction testing was used to measure differential associations between biomarkers and pump failure versus sudden cardiac death .
METHODS	Discrimination and risk reclassification metrics were used to assess the added value of galectin-3 and ST2 in predicting mode of death risk beyond a clinical model that included NT-proBNP .
RESULTS	After a median follow-up period of 2.5 years , there were 155 deaths : 49 from pump failure , 42 from sudden cardiac death , and 64 from other causes .
RESULTS	Elevations in all biomarkers were associated with increased risk for both pump failure and sudden cardiac death in both adjusted and unadjusted analyses .
RESULTS	In each case , increases in the biomarker had a stronger association with pump failure than sudden cardiac death , but this relationship was attenuated after adjustment for clinical risk factors .
RESULTS	Clinical variables along with NT-proBNP levels were stronger predictors of pump failure ( C statistic : 0.87 ) than sudden cardiac death ( C statistic : 0.73 ) .
RESULTS	Addition of ST2 and galectin-3 led to improved net risk classification of 11 % for sudden cardiac death , but not pump failure .
CONCLUSIONS	Clinical predictors along with NT-proBNP levels were strong predictors of pump failure risk , with insignificant incremental contributions of ST2 and galectin-3 .
CONCLUSIONS	Predictability of sudden cardiac death risk was less robust and enhanced by information provided by novel biomarkers .

###24925227
BACKGROUND	Lack of adherence to recommended treatment for obstructive sleep apnea remains an ongoing public health challenge .
BACKGROUND	Despite evidence that continuous positive airway pressure ( CPAP ) is effective and improves overall quality of life , adherence with the use of CPAP in certain racial/ethnic groups , especially blacks , is suboptimal .
BACKGROUND	Evidence indicates that the incidence and prevalence of obstructive sleep apnea are higher among blacks , relative to whites , and blacks are less likely to adhere to recommended treatment compared with other racial/ethnic groups .
METHODS	Using a two-arm randomized controlled design , this study will evaluate the effectiveness of a culturally and linguistically tailored telephone-delivered intervention to promote adherence to physician-recommended sleep apnea assessment and treatment among blacks with metabolic syndrome , versus an attention-control arm .
METHODS	The intervention is designed to foster adherence to recommended sleep apnea care using the stages-of-change model .
METHODS	The intervention will be delivered entirely over the telephone .
METHODS	Participants in the intervention arm will receive 10 phone calls to address challenges and barriers to recommended care .
METHODS	Outcomes will be assessed at baseline , and at 6 - and 12-months post-randomization .
CONCLUSIONS	This tailored behavioral intervention will improve adherence to sleep apnea assessment and treatment among blacks with metabolic syndrome .
CONCLUSIONS	We expect to demonstrate that this intervention modality is feasible in terms of time and cost and can be replicated in populations with similar racial/ethnic backgrounds .
BACKGROUND	The study is registered at clinicaltrials.gov NCT01946659 ( February 2013 ) .

###24871703
BACKGROUND	Previous studies have shown that oxytocin ( OXT ) enhances social cognitive processes .
BACKGROUND	It has also been demonstrated that OXT does not uniformly facilitate social cognition .
BACKGROUND	The effects of OXT administration strongly depend on the exposure to stressful experiences in early life .
BACKGROUND	Emotional facial recognition is crucial for social cognition .
BACKGROUND	However , no study has yet examined how the effects of OXT on the ability to identify emotional faces are altered by early life stress ( ELS ) experiences .
BACKGROUND	Given the role of OXT in modulating social motivational processes , we specifically aimed to investigate its effects on the recognition of approach - and avoidance-related facial emotions .
METHODS	In a double-blind , between-subjects , placebo-controlled design , 82 male participants performed an emotion recognition task with faces taken from the `` Karolinska Directed Emotional Faces '' set .
METHODS	We clustered the six basic emotions along the dimensions approach ( happy , surprise , anger ) and avoidance ( fear , sadness , disgust ) .
METHODS	ELS was assessed with the Childhood Trauma Questionnaire ( CTQ ) .
RESULTS	Our results showed that OXT improved the ability to recognize avoidance-related emotional faces as compared to approach-related emotional faces .
RESULTS	Whereas the performance for avoidance-related emotions in participants with higher ELS scores was comparable in both OXT and placebo condition , OXT enhanced emotion recognition in participants with lower ELS scores .
RESULTS	Independent of OXT administration , we observed increased emotion recognition for avoidance-related faces in participants with high ELS scores .
CONCLUSIONS	Our findings suggest that the investigation of OXT on social recognition requires a broad approach that takes ELS experiences as well as motivational processes into account .

###25143374
BACKGROUND	Low-birth-weight children are known to be at risk of both anemia and cognitive/language deficits in their early years .
OBJECTIVE	The aim of the current study was to examine the effects of a 22-element multiple micronutrient powder ( MNP ) on the cognitive and language development of full-term low-birth-weight ( LBW-T ) children in Bangladesh .
METHODS	The current study was a follow-up of children who were enrolled in a randomized cluster trial at 7-12 mo of age .
METHODS	Children in 12 intervention clusters ( communities ) were administered a daily 22-element MNP sachet with their food for 5 mo , and both intervention and control groups ( also 12 clusters ) received nutrition , health , and hygiene education .
METHODS	The current study involved the assessment of children at 16-22 mo of age ( 22-element MNP group : n = 96 ; control group : n = 82 ) on 3 subtests of the Bayley Scales of Infant and Toddler Development III test to measure cognitive , receptive language , and expressive language development .
RESULTS	There was a significant effect of the 22-element MNP on children 's expressive language scores ( d = 0.39 ) , and stunting moderated the effect on receptive language scores ; there was no effect on cognitive development ( d = 0.08 ) .
CONCLUSIONS	An MNP may thus offer one feasible solution to improve language development of LBW-T children in low-resource community settings .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01455636 .

###25040487
OBJECTIVE	We aimed to develop and establish the reliability and validity of a measure of Fear of Recurrence , measuring cognitive appraisals of relapse rather than standard early signs of relapse .
OBJECTIVE	We also aimed to establish the sensitivity and specificity to relapse .
METHODS	Participants diagnosed with schizophrenia or a related disorder were randomized to one of two early signs monitoring conditions , using either the Early Signs Scale or the Fear of Recurrence Scale ( FoRSe ) .
METHODS	Participants were followed up for 6-months or until relapse .
RESULTS	A total of 169 participants were randomized to Standard ( n = 86 ) or FoRSe ( n = 83 ) monitoring .
RESULTS	We found good evidence supporting reliability and validity of the FoRSe .
RESULTS	In addition , a cut-off point of 5 was associated with an optimal sensitivity in both Standard ( n = 26:79 % , 95 % CI = 62-89 ) and FoRSe ( n = 18:72 % , 95 % CI = 52-86 ) monitoring .
RESULTS	However , this degree of sensitivity was associated with a lower specificity in Standard ( n = 30:35 % , 96 % CI = 23-50 ) and FoRSe ( n = 25:46 % , 95 % CI = 32-60 ) .
RESULTS	Finally , Fear of Relapse was a significant predictor of time to relapse [ Exp ( ) = 1.20 , 95 % CI = 1.01-1 .42 , p < .05 ] .
CONCLUSIONS	The study provides evidence that Fear of Recurrence may be an important clinical construct linked to increased risk of relapse and poorer emotional recovery in people diagnosed with schizophrenia .
CONCLUSIONS	Monitoring Fear of Recurrence is as sensitive to relapse detection as monitoring early signs alone .
CONCLUSIONS	Greater Fear of Relapse was associated with shorter duration to actual relapse .
CONCLUSIONS	Fear of recurrence may be an important clinical feature linked to poorer emotional recovery and increased risk of relapse .
CONCLUSIONS	Fear of Recurrence may be an important focus of psychological therapy to promote emotional recovery and prevention of relapse .

###24988413
OBJECTIVE	Compare the long-term effects of an energy-restricted very low-carbohydrate , high-fat ( LC ) diet with an isocaloric high-carbohydrate , low-fat ( HC ) diet on exercise tolerance and capacity in overweight and obese adults .
METHODS	Seventy-six adults ( 25 males ; age 49.2 1.1 years ; BMI 33.6 0.5 kg/m ( 2 ) ) were randomized to either a hypocaloric ( 6-7 MJ/day ) LC diet ( 35 % protein , 4 % carbohydrate , 61 % fat ) or isocaloric HC diet ( 24 % protein , 46 % carbohydrate , 30 % fat ) for 52 weeks .
METHODS	Pre - and postintervention , participants ' body weight and composition , handgrip , and isometric knee extensor strength were assessed and participants performed an incremental exercise test to exhaustion .
RESULTS	Forty-three participants completed the study ( LC = 23 ; HC = 20 ) .
RESULTS	Overall , peak relative oxygen uptake increased ( +11.3 % ) and reductions occurred in body weight ( -14.6 % ) , body fat percentage ( -6.9 % [ absolute ] ) , isometric knee extensor strength ( -12.4 % ) , handgrip strength ( -4.5 % ) , and absolute peak oxygen uptake ( -5.2 % ; p 0.02 time for all ) with no diet effect ( p 0.18 ) .
RESULTS	During submaximal exercise , rating of perceived exertion did not change in either group ( p = 0.16 time , p = 0.59 Time Group ) .
RESULTS	Compared to the HC diet , the LC diet had greater reductions in respiratory exchange ratio ( LC -0.04 0.01 , HC -0.00 0.01 ; p = 0.03 ) , and increased fat oxidation ( LC 15.0 5.3 % [ of energy expenditure ] , HC 0.5 3.9 % ; p = 0.04 ) .
CONCLUSIONS	In overweight and obese patients , an LC diet promoted greater fat utilization during submaximal exercise .
CONCLUSIONS	Both an LC diet and an HC diet had similar effects on aerobic capacity and muscle strength , suggesting that long-term consumption of an LC weight loss diet does not adversely affect physical function or the ability to perform exercise .

###25241377
OBJECTIVE	To test if nucleolar channel system ( NCS ) prevalence matches the accuracy of the endometrial receptivity array ( ERA ) for identification of the window of endometrial receptivity .
METHODS	Comparative retrospective study , May 2008-May 2012 .
METHODS	University-affiliated infertility clinic .
METHODS	Forty-nine healthy oocyte donors , regularly cycling , aged 20-34 years with a body mass index of 19-25 kg/m2 .
METHODS	Endometrial biopsies were collected throughout the menstrual cycle .
METHODS	All samples underwent transcriptomic signature identification by ERA testing ( performed in a prior study ) and quantification of NCS prevalence by using indirect immunofluorescence ( performed in the present study ) .
METHODS	Concordance of ERA results determining the window of implantation with NCS prevalence was statistically analyzed using the kappa index .
METHODS	Based on dating according to the luteinizing hormone surge , specimens were dichotomized into receptive ( n = 24 ) and nonreceptive ( n = 25 ) .
METHODS	The NCS prevalence was expressed as percentage of NCSs per endometrial epithelial cells in each endometrial biopsy .
RESULTS	Concordance of ERA and NCS dating vs. luteinizing hormone yielded comparable kappa indices of 0.878 and 0.836 , respectively .
RESULTS	Direct comparison of ERA and NCS dating resulted in a kappa index of 0.796 .
CONCLUSIONS	Prevalence of NCS identifies the window of endometrial receptivity previously identified by their transcriptomic signature using the ERA .

###24330381
OBJECTIVE	Continuous lumbar plexus blocks provide excellent analgesia for total hip arthroplasty ( THA ) , but their utility has been questioned as they may increase motor weakness .
OBJECTIVE	The aim of this study was to compare the efficacy of two different concentrations of ropivacaine on both postoperative analgesia and motor function .
METHODS	Thirty patients were examined in this prospective , single center , double-blinded , parallel group , comparative , randomized controlled trial in patients undergoing primary THA .
METHODS	Lumbar plexus catheters were inserted preoperatively .
METHODS	After surgery , patients were randomly assigned to receive an infusion of ropivacaine at a concentration of either 0.1 % ( group 0.1 % ) or 0.2 % ( group 0.2 % ) at a standardized volume of 7mL per hour for 24 hours .
METHODS	Patients were also given free access to patient-controlled analgesia hydromorphone for 24 hours , supplemental intravenous ( IV ) opiates , and boluses of their assigned local anesthetic concentration via the lumbar plexus catheter .
METHODS	The primary endpoint was total hydromorphone consumption in 24 hours .
METHODS	Secondary endpoints included pain scores , sensory and motor function , and patient satisfaction .
RESULTS	There was no significant difference in hydromorphone consumption in the first 24 hours postoperatively ( mean [ 95 % confidence interval ] ) between group 0.1 % ( 8.02 mg [ 6.02-10 .02 ] ) and group 0.2 % ( 8.21 mg [ 5.75-10 .69 ] , P = 0.90 ) .
RESULTS	The volume of local anesthetic received , pain scores , sensory and motor function , and patient satisfaction did not vary between groups .
CONCLUSIONS	Following primary THA , lumbar plexus perineural infusion of 0.1 % ropivacaine provided similar benefits for postoperative analgesia and functional recovery as 0.2 % ropivacaine .

###25079465
OBJECTIVE	The aim of this study was to determine the effects of synbiotic food consumption on glycemic status and serum high sensitivity C-reactive protein ( hs-CRP ) levels of Iranian pregnant women .
METHODS	This randomized placebo-controlled clinical trial was performed among 52 pregnant women , primigravida , aged 18-35 year old , in their third trimester .
METHODS	After a 2-wk run-in period , subjects were randomly assigned to consume either a synbiotic ( n = 26 ) or control food ( n = 26 ) for 9 weeks .
METHODS	The synbiotic food consisted of a probiotic Lactobacillus sporogenes ( 1107 CFU ) , 0.04 g inulin as prebiotic with 0.38 g isomalt , 0.36 g sorbitol and 0.05 g stevia as sweetener per 1 g. Control food ( the same substance without probiotic bacteria and inulin ) was packed in identical 9-gram packages .
METHODS	Patients were asked to consume the synbiotic and control foods two times a day .
METHODS	Fasting blood samples were taken at baseline and after a 9-wk intervention for quantification of related factors .
RESULTS	Consumption of a synbiotic food did not show any significant change regarding the impact of insulin actions in the synbiotic group ; nonetheless , compared to the control food , it resulted in a significant decrease in serum insulin levels ( -0.26 vs. 6.34 IU/mL , P = 0.014 ) and HOMA-IR ( -0.13 vs. 1.13 , P = 0.033 ) , a significant difference in HOMA-B ( 5.30 vs. 34.22 , P = 0.040 ) and a significant rise in QUICKI score ( 0.002 vs. -0.02 , P = 0.022 ) .
CONCLUSIONS	Consumption of a synbiotic food for 9 weeks by pregnant women had beneficial effects on insulin actions compared to the control food , but did not affect FPG and serum hs-CRP concentrations .

###24861134
OBJECTIVE	Macitentan is a novel dual endothelin receptor antagonist recently approved for the treatment of pulmonary arterial hypertension ( PAH ) .
OBJECTIVE	Warfarin , an anticoagulant often prescribed to patients with PAH , has a narrow therapeutic index and is prone to potential interactions with drugs .
OBJECTIVE	This study assessed the effects of macitentan on the pharmacokinetics and pharmacodynamics of single-dose warfarin in healthy subjects .
METHODS	This was a randomised , open-label , single-centre , two-way crossover ( treatment A followed by treatment B , or vice versa ) , phase I study in 14 healthy male subjects .
METHODS	Treatment A was a loading dose of macitentan 30 mg on Day 1 followed by 10 mg once daily for 8 days , with a single 25 mg dose of warfarin on Day 4 .
METHODS	Treatment B was a single dose of warfarin on Day 1 .
METHODS	Blood samples were assessed for warfarin pharmacokinetics ( R - and S-warfarin ) and pharmacodynamics [ international normalised ratio ( INR ) and factor VII ] .
METHODS	Plasma trough concentrations of macitentan and its active metabolite ( ACT-132577 ) and the safety and tolerability of each treatment were also assessed .
RESULTS	Plasma concentrations of R - and S-warfarin were similar in both treatment periods .
RESULTS	Warfarin did not affect the mean trough plasma concentrations of macitentan or ACT-132577 .
RESULTS	Macitentan did not affect the pharmacodynamics of warfarin ; the mean INR and factor VII activity versus time profiles were similar with and without macitentan .
CONCLUSIONS	The absence of effect of macitentan on the pharmacokinetics and pharmacodynamics of a single dose of warfarin suggests that both drugs can be concomitantly administered without need for dose adjustment .

###25368978
BACKGROUND	The protective effect of breast-feeding against later obesity may be explained by the lower protein content compared with formula milk .
BACKGROUND	However , the metabolic mechanisms remain unknown .
OBJECTIVE	We studied the metabolic response to a higher or lower protein supply in infancy .
METHODS	The Childhood Obesity Project study is a double-blind , randomized , multicenter intervention trial .
METHODS	Infants were randomized to receive a higher ( HP ) or lower protein ( LP ) content infant formula or were breast-fed .
METHODS	Plasma samples of 691 infants who received formula milk with different protein content ( HP , 2.05 g per 100 mL ; LP , 1.25 g per 100 mL ) or were breast-fed were collected .
METHODS	Changes in plasma amino acid and acylcarnitine concentrations of 6-month-old infants according to different dietary protein supply were determined by liquid chromatography coupled to tandem mass spectrometry .
RESULTS	Twenty-nine metabolites differed significantly between the formula groups .
RESULTS	Branched-chain amino acids ( BCAAs ) were the most discriminant metabolites .
RESULTS	Their degradation products , the short-chain acylcarnitines C3 , C4 , and C5 , were also significantly elevated in the HP group .
RESULTS	A breakpoint analysis confirmed that with increasing BCAAs , the ratio between acylcarnitines and BCAAs decreases .
RESULTS	Long-chain acylcarnitines were decreased in HP infants .
CONCLUSIONS	BCAAs seem to play a pivotal role in the effect of a high-protein diet on - oxidation and fat storage .
CONCLUSIONS	We provide new evidence for a possible saturation of the BCAA degradation pathway that may represent the mechanism by which high-protein intake affects the metabolic regulation .
CONCLUSIONS	Moreover , it appears to inhibit the initial step of the - oxidation , thus leading to high early weight gain and body fat deposition .

###24565125
OBJECTIVE	This study was conducted to investigate the effects of reinsertion of the stylet after a spinal anesthesia procedure on the Post Dural Puncture Headache ( PDPH ) METHODS : We have enrolled into this study 630 patients who were undergoing elective operations with spinal anesthesia and randomized them to Group A ( stylet replacement before needle removal ) and Group B ( needle removal without stylet replacement ) .
OBJECTIVE	These patients were observed for the duration of 24 hours in the hospital and they were checked for PDPH on the 3 ( rd ) and the 7 ( th ) day of the study .
RESULTS	Overall , the PDPH incidence was at 10.8 % ( 68 patients ) .
RESULTS	Thirty-three of these patients ( 10.5 % ) who were in Group A ( stylet replacement before needle removal ) and the other 35 patients ( 11.1 % ) who were in Group B ( needle removal without stylet replacement ) experienced PDPH .
RESULTS	There was no significant difference between the two groups with respect to the PDPH .
CONCLUSIONS	In contrary to the diagnostic lumbar puncture , reinsertion of the stylet after spinal anesthesia with 25-gauge Quincke needles does not reduce the incidence of PDPH .

###24846173
OBJECTIVE	Increased sympathetic activation and reduced parasympathetic tone are important pathophysiological contributors to the progression of heart failure , and are associated with poor outcome in patients .
OBJECTIVE	The aim of this study is to determine if vagal nerve stimulation ( VNS ) is a promising approach to modulate autonomic function and slow cardiac remodelling and the progression of heart failure .
METHODS	The NECTAR-HF ( NEural Cardiac TherApy foR Heart Failure ) trial is designed to evaluate whether the Boston Scientific VNS device is safe and may attenuate cardiac remodelling , improve cardiac function and increase exercise capacity , in symptomatic heart failure patients ( New York Heart Association Class II-III ) with left ventricular systolic dysfunction ( ejection fraction 35 % ) and receiving optimal medical therapy .
METHODS	Patients will be randomized in a 2:1 ratio to receive standard optimal medical treatment plus VNS system in an active mode vs. optimal medical treatment plus VNS system in an inactive mode , for a 6month period .
METHODS	After the 6month control period , inactive VNS systems will be activated and all patients will receive VNS .
METHODS	The study is powered to detect differences in the primary efficacy endpoint of change in left ventricular end systolic diameter .
METHODS	Secondary endpoints include ejection fraction , left ventricular volumes , quality of life scores , functional capacity , and changes in biomarkers .
CONCLUSIONS	This Phase II , randomized clinical trial conducted with vagal stimulation for heart failure will provide important new information on the potential of this novel and promising technique .

###24366288
BACKGROUND	Proton pump inhibitors ( PPIs ) are affected by cytochrome P450 2C19 ( CYP2C19 ) polymorphisms .
BACKGROUND	This study compared the effect of two PPIs on early symptom relief in Japanese patients with reflux esophagitis , classified by the CYP2C19 phenotype .
METHODS	Patients with reflux esophagitis were randomised to treatment with omeprazole 20 mg or rabeprazole 10 mg once daily .
METHODS	The CYP2C19 phenotype [ homozygous extensive metaboliser ( homoEM ) , heterozygous extensive metaboliser ( heteroEM ) or poor metaboliser ( PM ) ] of each patient was determined .
METHODS	The primary efficacy endpoint was early , sufficient ( Global Overall Symptom scale score 1 or 2 ) , sustained ( maintained for 7 days ) reflux symptom relief .
RESULTS	Of the 199 patients included in this analysis , the proportion achieving sufficient , sustained reflux symptom relief was higher with omeprazole than with rabeprazole on day 1 ( 35.6 vs. 22.4 % ; p = 0.041 ) and day 2 ( 43.6 vs. 28.6 % ; p = 0.028 ) ; there was no significant difference between the two groups on days 3-7 .
RESULTS	Among patients with the CYP2C19 PM phenotype , sufficient , sustained reflux symptom relief was higher with omeprazole than with rabeprazole on days 4-7 ( 62.5-66 .9 vs. 31.6 % ; p 0.03 ) ; differences were not significant on days 1-3 , or among those with the homoEM or heteroEM phenotypes on days 1-7 .
CONCLUSIONS	In Japanese patients with reflux esophagitis , omeprazole 20 mg is more effective than rabeprazole 10 mg at achieving early , sufficient , sustained reflux symptom relief in individuals with the CYP2C19 PM phenotype , and is similarly effective to rabeprazole 10 mg in those with heteroEM or homoEM phenotypes .

###24323569
BACKGROUND	Negative affect , alcohol consumption , and presence of others smoking have consistently been implicated as risk factors for smoking lapse and relapse .
BACKGROUND	What is not known , however , is how these factors work together to affect smoking outcomes .
BACKGROUND	This paper uses ecological momentary assessment ( EMA ) collected during the first 7 days of a smoking cessation attempt to test the individual and combined effects of high-risk triggers on smoking urge and lapse .
METHODS	Participants were 300 female smokers who enrolled in a study that tested an individually tailored smoking cessation treatment .
METHODS	Participants completed EMA , which recorded negative affect , alcohol consumption , presence of others smoking , smoking urge , and smoking lapse , for 7 days starting on their quit date .
RESULTS	Alcohol consumption , presence of others smoking , and negative affect were , independently and in combination , associated with increase in smoking urge and lapse .
RESULTS	The results also found that the relationship between presence of others smoking and lapse and the relationship between negative affect and lapse were moderated by smoking urge .
CONCLUSIONS	The current study found significant individual effects of alcohol consumption , presence of other smoking , and negative affect on smoking urge and lapse .
CONCLUSIONS	Combing the triggers increased smoking urge and the risk for lapse to varying degrees , and the presence of all 3 triggers resulted in the highest urge and lapse risk .

###25562510
OBJECTIVE	To evaluate whether adding functional exercise training to standard physiotherapy during residential slow-stream rehabilitation ( SSR ) improves discharge outcomes and functional ability .
METHODS	Randomized controlled trial .
METHODS	A regional hospital .
METHODS	Older people ( N = 60 ) admitted to SSR .
METHODS	All participants received standard physiotherapy .
METHODS	An individualized functional incidental training ( FIT ) program was implemented for intervention participants consisting of 4 extra episodes of functional exercise daily for the period of SSR .
METHODS	Research assistants visited twice weekly to practice and progress FIT programs .
METHODS	Outcome measures included discharge destination , participant-expected discharge destination , and functional tests of the Berg Balance Scale ( BBS ) , de Morton Mobility Index ( DEMMI ) , and 5 times sit-to-stand test ( FTSTS ) at admission and discharge .
RESULTS	Fifty-two participants completed the study .
RESULTS	At baseline , the SSR group achieved higher scores on the BBS , DEMMI , and FTSTS .
RESULTS	There was no significant difference in discharge destination between groups ( P = .305 ) .
RESULTS	The difference in functional change between groups from admission to discharge on the BBS , DEMMI , and FTSTS was not significant .
RESULTS	Participant-expected discharge destination was significantly associated with eventual discharge destination ( 1 ( 2 ) = 8.40 , P = .004 ) .
CONCLUSIONS	Adding FIT to standard physiotherapy did not improve discharge outcomes and did not have a statistically significant effect on function , but may have a small effect on balance .
CONCLUSIONS	Patient expected and actual discharge destinations were associated .

###25079979
OBJECTIVE	The aim of this study was to investigate the site-specific effects of repetitive transcranial magnetic stimulation ( rTMS ) on freezing of gait ( FOG ) in patients with parkinsonism .
METHODS	Twenty patients with parkinsonism and FOG were included .
METHODS	A single session of 10 Hz rTMS was applied over three different cortical regions of the dominant hemisphere : the primary motor cortex of the lower leg ( M1-LL ) , the supplementary motor area ( SMA ) , and the dorsolateral prefrontal cortex ( DLPFC ) .
METHODS	We also performed sham stimulation as a control .
METHODS	The Timed Up and Go ( TUG ) test , Turn Steps and Turn Time in 180 turning , Unified Parkinson 's Disease Rating Scale ( UPDRS ) part III , FOG Questionnaire ( FOG-Q ) , and motor evoked potential ( MEP ) studies were performed before and after each intervention .
RESULTS	There were significant improvements in TUG test times after rTMS over the M1-LL and the DLPFC .
RESULTS	Improvement was significantly greater after the M1-LL stimulation than sham condition .
RESULTS	The M1-LL and DLPFC stimulation also resulted in significant improvements in both the number of Turn Steps and Turn Time .
RESULTS	UPDRS-III scores were significantly decreased after the M1-LL and DLPFC stimulation .
CONCLUSIONS	Use of 10 Hz rTMS on the M1-LL and DLPFC is therapeutically effective for FOG in patients with parkinsonism .

###24283587
OBJECTIVE	Although transnasal endoscopy ( TNE ) is generally a comfortable and safe procedure , it has some disadvantages , such as complicated preprocessing and occasional repulsion reaction during catheterization .
OBJECTIVE	In an attempt to simplify the preprocessing method , the efficacy of a catheter-free method in which a catheter is not inserted into the nasal cavity was assessed .
METHODS	The present study was a prospective , open-label , single-center , randomized controlled study with parallel assignment allocation 1:1 .
METHODS	Between March 2009 and August 2009 , a total of 93 TNE-nave patients were enrolled and randomized .
METHODS	Patients were prospectively randomized into two groups ( catheter-free vs catheter-insertion method ) .
METHODS	Patients who prepared according to the catheter-free method and who were unsuccessful underwent the catheter-insertion method .
METHODS	Clinical characteristics , success rate , complications , vital signs , acceptability , and tolerability were assessed and compared .
RESULTS	Success rates of the catheter-free and catheter-insertion methods were 88 % ( n = 44 ) and 88 % ( n = 38 ) ( P > 0.05 ) , respectively .
RESULTS	Causes of failure in the catheter-free method included severe rhinalgia ( n = 1 , 2 % ) and narrowing of the nasal cavity ( n = 5 , 10 % ) .
RESULTS	Causes of failure in the catheter-insertion method included narrowing of the nasal cavity ( n = 5 , 11 % ) .
RESULTS	Six patients whose TNE failed with the catheter-free method also experienced failed TNE with the catheter-insertion method .
RESULTS	There were no statistical differences in vital signs , acceptability , and tolerability .
CONCLUSIONS	The catheter-free method is sufficient for preparation for TNE .
CONCLUSIONS	The success rate of TNE depends more on the structure of the nasal cavity than the preprocessing method .

###24472731
BACKGROUND	Subclinical diabetic cardiomyopathy ( DCM ) is frequent in asymptomatic subjects with type 2 diabetes ( T2DM ) .
BACKGROUND	We sought the response of functional and fibrosis markers to therapy in a trial of aldosterone antagonism for treatment of DCM .
METHODS	Biochemical , anthropometric , and echocardiographic data were measured in 225 subjects with T2DM .
METHODS	Myocardial function was evaluated with standard echocardiography and myocardial deformation ; ischaemia was excluded by exercise echocardiography .
METHODS	Calibrated integrated backscatter and post-contrast T1 mapping from cardiac magnetic resonance imaging were used to assess myocardial structure .
METHODS	Amino-terminal propeptides of pro-collagen type I ( PINP ) and III ( PIIINP ) , the carboxy-terminal propeptide of pro-collagen type I ( PICP ) and transforming growth factor beta-1 were measured from peripheral blood or urine to assess myocardial collagen turnover .
RESULTS	Diastolic dysfunction was identified in 81 individuals , of whom 49 ( 25 male , age 60 10 years ) were randomized to spironolactone 25 mg/day or placebo therapy for 6 months .
RESULTS	Groups were well-matched at baseline .
RESULTS	Spironolactone therapy was associated with improvements in diastolic filling profile ( peak E wave velocity -4 15 vs. 9 10 ms , P = 0.001 ; E/A ratio -0.1 0.3 vs. 0.2 0.2 , P < 0.001 ) and cIB values ( -21.2 4.5 dB vs. -18.0 5.2 dB , P = 0.026 ; cIB -5.1 6.8 vs. -1.3 5.2 , P = 0.030 ) .
RESULTS	cIB was independently associated with spironolactone therapy ( = 0.320 , P = 0.026 ) but not blood pressure .
RESULTS	With intervention , pro-collagen biomarkers ( PINP P = 0.92 , PICP P = 0.25 , PIIINP P = 0.52 , and TGF-1 P = 0.71 ) and T1 values ( P = 0.54 ) remained similar between groups .
CONCLUSIONS	Spironolactone-induced changes in myocardial structure and diastolic properties in DCM are small , and are unassociated with changes in collagen biomarkers or T1 values .

###24885220
BACKGROUND	The burden of acute gastroenteritis on children and their families continues to be enormous .
BACKGROUND	Probiotics , defined as viable microbial preparations that have a beneficial effect on the health of the host , represent a rapidly expanding field .
BACKGROUND	Although clinical trials in children with gastroenteritis have been performed , most have significant flaws , and guidelines do not consistently endorse their use .
METHODS	PROGUT is a randomized , placebo-controlled , double-blind , five-center , Canadian , emergency department trial .
METHODS	Children aged 3months to 48months who present between November 2013 and June 2017 with < 72hours of gastroenteritis symptoms will be assessed for eligibility .
METHODS	A total of 886 children will be randomized ( 1:1 allocation via an internet based , third party , randomization service ) to receive 5days of a combination probiotic agent ( Lactobacillus rhamnosus and L. helveticus ) or placebo .
METHODS	All participants , caregivers , and outcome assessors will be blinded to group assignment .
METHODS	The study includes three key outcomes : 1 ) clinical - the development of moderate to severe disease following an emergency department ( ED ) evaluation that employs a validated clinical score ( Modified Vesikari Scale ) ; 2 ) safety - side effect ; and 3 ) mechanism - fecal secretory immunoglobulin A levels .
CONCLUSIONS	Definitive data are lacking to guide the clinical use of probiotics in children with acute gastroenteritis .
CONCLUSIONS	Hence , probiotics are rarely prescribed by North American physicians .
CONCLUSIONS	However , the following current trends obligate an urgent assessment : 1 ) probiotics are sold as food supplements , and manufacturers can encourage their use while their relevance has yet to be established ; 2 ) North American and European government agencies remain concerned about their value and safety ; 3 ) some institutions are now recommending the routine use of probiotics ; and 4 ) parents of affected children are often providing probiotics .
CONCLUSIONS	With probiotic consumption increasing in the absence of solid evidence , there is a need to conduct this definitive trial to overcome the limitations of prior work in this field .
BACKGROUND	ClinicalTrials.gov : NCT01853124 ; first registered 9 May 2013 .

###25673976
BACKGROUND	During menopause , the decrease of estrogenic secretion induces the disruption of skin functioning , thus causing the decline in skin elasticity characteristic of skin aging .
BACKGROUND	The purpose of this study was to evaluate in postmenopausal women the effect of daily consumption and/or application of argan oil on skin elasticity .
METHODS	Sixty postmenopausal women consumed butter during the stabilization period and were randomly divided into two groups for the intervention period : the treatment group of 30 participants received dietary argan oil , the control group of 30 participants received olive oil , and both groups applied cosmetic argan oil in the left volar forearm during a 60-day period .
METHODS	Assessments of skin elasticity parameters , ie , the three R-parameters ( R2 or gross-elasticity of the skin , R5 or net elasticity of the skin , and R7 or biological elasticity ) , and the resonance running time ( RRT ) at both volar forearms of the two groups were performed during three visits : before starting oils consumption and application , after 30 days of oils consumption and application , and after 60 days of oils consumption and application .
RESULTS	The consumption of argan oil led to a significant increase of gross-elasticity of the skin ( R2 ) ( P < 0.001 ) , net elasticity of the skin ( R5 ) ( P < 0.001 ) , biological elasticity ( R7 ) ( P < 0.001 ) , and a significant decrease of RRT ( P = 0.002 ) .
RESULTS	The application of argan oil led to a significant increase of gross-elasticity of the skin ( R2 ) ( P < 0.001 ) , net elasticity of the skin ( R5 ) ( P < 0.001 ) , biological elasticity ( R7 ) ( P = 0.001 ) , and a significant decrease of RRT ( P < 0.001 ) .
CONCLUSIONS	Our findings suggest that the daily consumption and/or topical application of argan oil have an anti-aging effect on the skin demonstrated by the improvement of skin elasticity , characterized by an increase of R-parameters ( R2 , R5 , and R7 ) and a decrease of RRT .

###25078387
BACKGROUND	The effectiveness of trivalent influenza vaccines may be reduced in older versus younger adults because of age-related immunosenescence .
BACKGROUND	The use of an adjuvant in such a vaccine is one strategy that may combat immunosenescence , potentially by bolstering T-cell mediated responses .
METHODS	This observer-blind study , conducted in the United States ( US ) and Spain during the 2008-2009 influenza season , evaluated the effect of Adjuvant System AS03 on specific T-cell responses to a seasonal trivalent influenza vaccine ( TIV ) in 65 year-old adults.Medically-stable adults aged 65 years were randomly allocated to receive a single dose of AS03-adjuvanted TIV ( TIV/AS03 ) or TIV .
METHODS	Healthy adults aged 18-40 years received only TIV .
METHODS	Blood samples were collected on Day 0 , Day 21 , Day 42 and Day 180 .
METHODS	Influenza-specific CD4 + T cells , defined by the induction of the immune markers CD40L , IL-2 , IFN - , or TNF - , were measured in ex vivo cultures of antigen-stimulated peripheral blood mononuclear cells .
RESULTS	A total of 192 adults were vaccinated : sixty nine and seventy three 65 year olds received TIV/AS03 and TIV , respectively ; and fifty 18 - 40 year olds received TIV .
RESULTS	In the 65 year-old group on Day 21 , the frequency of CD4 + T cells specific to the three vaccine strains was superior in the TIV/AS03 recipients to the frequency in TIV ( p < 0.001 ) .
RESULTS	On Days 42 and 180 , the adjusted-geometric mean specific CD4 + T-cell frequencies were also higher in the TIV/AS03 recipients than in the TIV recipients ( p < 0.001 ) .
RESULTS	Furthermore , the adjusted-geometric mean specific CD4 + T-cell frequencies were higher in the 65 year-old recipients of TIV/AS03 than in the18 - 40 year old recipients of TIV on Days 21 ( p = 0.006 ) and 42 ( p = 0.011 ) .
CONCLUSIONS	This positive effect of AS03 Adjuvant System on the CD4 + T-cell response to influenza vaccine strains in older adults could confer benefit in protection against clinical influenza disease in this population .
BACKGROUND	( Clinicaltrials.gov . )
BACKGROUND	NCT00765076 .

###24733680
OBJECTIVE	The purpose of the study was to rigorously test Illness Management and Recovery ( IMR ) against an active control group in a sample that included veterans .
METHODS	A total of 118 participants with schizophrenia spectrum disorders , 56 of whom were veterans , were recruited from a Department of Veterans Affairs medical center and a community mental health center in the same city and were randomly assigned to an IMR group ( N = 60 ) or a weekly problem-solving group intervention ( N = 58 ) .
METHODS	Groups met weekly for nine months .
METHODS	Blinded assessments were conducted at baseline , nine months , and 18 months on measures of symptoms , functioning , illness self-management , medication adherence , subjective recovery experiences , and service utilization .
RESULTS	No significant differences were found between IMR and problem-solving groups .
RESULTS	Participants in both groups improved significantly over time in symptom severity , illness management , and quality of life and had fewer emergency department visits .
RESULTS	Participation rates in both interventions were low .
RESULTS	Only 28 % of consumers assigned to IMR and 17 % of those assigned to the problem-solving group participated in more than half the scheduled groups , and 23 % and 34 % , respectively , attended no sessions .
CONCLUSIONS	This is the first randomized controlled trial of IMR to report negative findings .
CONCLUSIONS	Given the inclusion of an active control group and the low participation rates , further research is needed to understand factors affecting IMR effectiveness .
CONCLUSIONS	Increased attention may need to be paid to facilitate more active participation in IMR , such as individual follow-up with consumers and the integration of IMR with ongoing treatment .

###24916808
OBJECTIVE	To analyze the clinical evaluation of Parkinson 's disease ( PD ) patients receiving integrated Chinese and Western medicine therapy .
METHODS	One hundred and twenty patients were enrolled and randomly allocated to a control group or treatment group .
METHODS	Patients in the two groups received placebo and Bushen Huoxue Granule ( , BHG ) , respectively .
METHODS	Both groups received baseline levodopa and benserazide ( Madopar ) .
METHODS	The effects of treatment were assessed monthly during the 9-month treatment .
METHODS	Means of evaluation included Unified PD Rating Scale ( UPDRS ) scores ( II and III ) , sleep scale score , 10 m turn back test ( getting up time , 10 m2 times , and turning time ) , timing motor test ( TMT ) - left and TMT-right , which were treated as the dependent variables ; and age , sex , duration of PD , Hoehn and Yahr ( H-Y ) stage and Madopar dosage of admitted PD patients were as the independent variables .
METHODS	Multiple linear regression was used to analyze these factors .
RESULTS	H-Y stage significantly affected UPDRS II score , UPDRS III score , and getting up time ( P < 0.01 ) .
RESULTS	Madopar dosage and H-Y stage significantly affected the 10 m2 times ( P < 0.05 or < 0.01 ) .
RESULTS	Madopar dosage significantly affected the sleep scale score ( P < 0.05 ) .
RESULTS	There were also significant correlations between age and TMT-left or TMT-right ( P < 0.01 ) , and duration of PD and TMT-right ( P < 0.05 ) .
CONCLUSIONS	The six assessed means of clinical evaluation ( including UPDRS II and UPDRS III scores , sleep scale score , getting up time , 10 m2 times , and turning time ) are sensitive indexes in all PD patients .
CONCLUSIONS	H-Y stage and Madopar dosage are the major factors influencing means of clinical assessment of PD treatment .

###25497252
BACKGROUND	Women are more likely than men to experience adverse cardiac events after ST-elevation myocardial ( STEMI ) .
BACKGROUND	Whether differences in infarct size or reperfusion contribute to sex differences in outcomes is unknown .
METHODS	We compared baseline and procedural characteristics , angiographic and electrocardiographic indices of reperfusion , microvascular obstruction , infarct size , and clinical outcomes in 118 women and 334 men with anterior STEMI enrolled in the INFUSE-AMI randomized trial of intralesion abciximab and aspiration thrombectomy ( NCT00976521 ) .
METHODS	Infarct size was assessed by cardiac magnetic resonance imaging at 30 days , and clinical end points were adjudicated by an independent committee .
RESULTS	Women were older , were more commonly affected by hypertension and renal impairment , and had a 50.5-minute longer delay to reperfusion .
RESULTS	There were no differences in infarct size , microvascular obstruction , or reperfusion success .
RESULTS	At 30 days , major adverse cardiac events ( MACE ) , defined as death , reinfarction , new-onset severe heart failure , or rehospitalization for heart failure , were more common in women ( 11.1 % vs 5.4 % , hazard ratio 2.09 , 95 % CI 1.03-4 .27 , P = .04 ) .
RESULTS	After multivariable adjustment , age , but not sex or time to reperfusion , was an independent predictor of MACE .
CONCLUSIONS	In the INFUSE-AMI randomized trial , women with anterior STEMI experienced a higher rate of MACE , attributable to older age .
CONCLUSIONS	Despite longer delay from symptom onset to reperfusion therapy , there was no difference between women and men in infarct size or reperfusion success .

###26181087
OBJECTIVE	To compare the efficacy of vaginal misoprostol with buccal misoprostol for second-trimester termination of pregnancies .
METHODS	In a randomized trial , we compared 400 micrograms vaginal and buccal misoprostol every 3 hours for up to six doses for induction of labor at 13-24 weeks of gestation with a live fetus and intact membranes .
METHODS	Women who had a uterine scar were excluded from the study .
METHODS	The primary outcome of the study was induction-to-abortion interval .
METHODS	Based on a two-tailed of 0.05 , we planned to include 65 patients per group to detect a 50 % difference in the primary outcome with a power of 80 % .
RESULTS	From January 2014 to December 2014 , 172 women were screened and 130 were randomized : 65 vaginal and 65 buccal misoprostol .
RESULTS	Characteristics of patients were similar between groups .
RESULTS	Patients administered vaginal misoprostol compared with buccal misoprostol had a shorter induction-to-abortion interval ( 2517 hours compared with 4029 hours , P = .001 ) and a higher abortion rate within both 24 hours ( 41 [ 63 % ] compared with 27 [ 42 % ] P = .014 ) and 48 hours ( 59 [ 91 % ] compared with 44 [ 68 % ] , P = .001 ) .
RESULTS	Complete abortion rates were similar in both groups ( vaginal 51 [ 78 % ] compared with buccal 54 [ 83 % ] ) .
RESULTS	The incidence of side effects was similar for both groups .
RESULTS	The perceived pain was higher in the buccal group , but the small difference did not appear to be clinically meaningful .
CONCLUSIONS	Vaginal compared with buccal misoprostol administration has a shorter induction-to-abortion interval for second-trimester termination of viable pregnancies .
CONCLUSIONS	However , both administration routes are equally effective for induction of termination .
BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT02048098 .
METHODS	I.

###24877590
BACKGROUND	Heart failure activates neurohormones , and elevated levels of brain natriuretic peptide ( BNP ) are associated with adverse outcomes .
BACKGROUND	The SENIORS trial showed that nebivolol , a highly selective beta-1 antagonist with vasodilating properties , reduced the composite outcome of all cause mortality or cardiovascular hospital admissions in older patients with heart failure .
BACKGROUND	We explored the effects of nebivolol on a range of neurohormones , cytokines and markers of nitric oxide activity in heart failure .
METHODS	In a subset of patients in SENIORS we measured N-terminal pro-brain natriuretic peptide ( NT-BNP ) , pro atrial natriuretic peptide ( Pro-ANP ) , endothelin-1 ( ET-1 ) , peripheral norepinephrine ( PNE ) , soluble Fas ( sFas ) , soluble Fas-ligand ( sFas-L ) , tumour necrosis factor-alpha ( TNF - ) , serum uric acid ( SUA ) , symmetrical dimethyl arginine ( SDMA ) , arginine , citrulline and asymmetrical dimethyl arginine ( ADMA ) at baseline ( before study drug ) , at 6 months and 12 months in a prespecified substudy .
RESULTS	One hundred and six patients were enrolled and 75 had a baseline and at least one follow-up sample .
RESULTS	There were no significant differences in neurohormone cytokines or nitric oxide markers measured between the two groups at six or twelve months .
RESULTS	NT-ProBNP showed a numerical increase in the nebivolol group compared to placebo ( P = 0.08 ) and sFas showed a numerical increase in patients on placebo ( P = 0.08 ) .
RESULTS	Mean baseline LVEF was 35 % in both groups and at 12 months was 43 % on nebivolol group and 34 % on placebo group ( P = 0.01 ) .
CONCLUSIONS	There were trends but no clear changes associated with nebivolol in neurohormones , cytokines or markers of nitric oxide activity in this study of elderly patients with heart failure .
CONCLUSIONS	Further studies are needed to understand the mechanistic effects of beta blockers on biomarkers in heart failure .

###25140956
BACKGROUND	Silent cerebral infarcts are the most common neurologic injury in children with sickle cell anemia and are associated with the recurrence of an infarct ( stroke or silent cerebral infarct ) .
BACKGROUND	We tested the hypothesis that the incidence of the recurrence of an infarct would be lower among children who underwent regular blood-transfusion therapy than among those who received standard care .
METHODS	In this randomized , single-blind clinical trial , we randomly assigned children with sickle cell anemia to receive regular blood transfusions ( transfusion group ) or standard care ( observation group ) .
METHODS	Participants were between 5 and 15 years of age , with no history of stroke and with one or more silent cerebral infarcts on magnetic resonance imaging and a neurologic examination showing no abnormalities corresponding to these lesions .
METHODS	The primary end point was the recurrence of an infarct , defined as a stroke or a new or enlarged silent cerebral infarct .
RESULTS	A total of 196 children ( mean age , 10 years ) were randomly assigned to the observation or transfusion group and were followed for a median of 3 years .
RESULTS	In the transfusion group , 6 of 99 children ( 6 % ) had an end-point event ( 1 had a stroke , and 5 had new or enlarged silent cerebral infarcts ) .
RESULTS	In the observation group , 14 of 97 children ( 14 % ) had an end-point event ( 7 had strokes , and 7 had new or enlarged silent cerebral infarcts ) .
RESULTS	The incidence of the primary end point in the transfusion and observation groups was 2.0 and 4.8 events , respectively , per 100 years at risk , corresponding to an incidence rate ratio of 0.41 ( 95 % confidence interval , 0.12 to 0.99 ; P = 0.04 ) .
CONCLUSIONS	Regular blood-transfusion therapy significantly reduced the incidence of the recurrence of cerebral infarct in children with sickle cell anemia .
CONCLUSIONS	( Funded by the National Institute of Neurological Disorders and Stroke and others ; Silent Cerebral Infarct Multi-Center Clinical Trial ClinicalTrials.gov number , NCT00072761 , and Current Controlled Trials number , ISRCTN52713285 . )

###24332581
BACKGROUND	The TARGIT ( TARGeted Intraoperative Radiotherapy ) trial was designed to compare local recurrence and complication rates in breast cancer patients , prospectively randomised to either EBRT ( external beam whole breast radiotherapy ) or a single dose of IORT ( intraoperative radiotherapy ) .
BACKGROUND	The aim of our study was to compare follow-up mammographic findings , ultrasound and biopsy rates in each group .
METHODS	Follow-up imaging and breast biopsies of women from one centre participating in the TARGIT-A trial were independently reviewed by two radiologists blinded to the radiotherapy treatment received .
RESULTS	The cohort consisted of 141 patients ( EBRT n = 80/IORT n = 61 ) .
RESULTS	There was no significant difference in the patient or disease characteristics of the two groups .
RESULTS	The number of follow-up mammograms and length of follow-up was similar ( EBRT/IORT n = 2.0 / 2.4 ; 4.3 yr/5 .1 yr ; p = 0.386 ( 2 ) test ) .
RESULTS	There were no significant differences in mammographic scar or calcification appearances of the post-operative site .
RESULTS	Generalised increase in breast density and skin thickening were more common in the EBRT compared to the IORT group ( p = 0.002 ; p = 0.030 , ( 2 ) test respectively ) .
RESULTS	A trend towards additional ultrasound at follow-up was observed in the IORT group ( 15 of 61 [ 24.6 % ] versus 11 of 80 [ 13.8 % ] ) , however this was not statistically significant ( p = 0.100 ( 2 ) test ) .
RESULTS	No disease recurrence was demonstrated on any of the breast biopsies taken .
RESULTS	Only one biopsy was reported as fat necrosis in the IORT group .
CONCLUSIONS	Mammographic changes were more common following EBRT , although more additional follow-up ultrasounds were performed in the IORT group .
CONCLUSIONS	IORT is not detrimental to subsequent radiological follow up .

###24333802
BACKGROUND	home-based telecare ( TC ) is utilised to manage risks of independent living and provide prompt emergency responses .
BACKGROUND	This study examined the effect of TC on health-related quality of life ( HRQoL ) , anxiety and depressive symptoms over 12 months in patients receiving social care .
METHODS	a study of participant-reported outcomes [ the Whole Systems Demonstrator ( WSD ) Telecare Questionnaire Study ; baseline n = 1,189 ] was nested in a pragmatic cluster-randomised trial of TC ( the WSD Telecare trial ) , held across three English Local Authorities .
METHODS	General practice ( GP ) was the unit of randomisation and TC was compared with usual care ( UC ) .
METHODS	participant-reported outcome measures were collected at baseline , short-term ( 4 months ) and long-term ( 12 months ) follow-up , assessing generic HRQoL , anxiety and depressive symptoms .
METHODS	Primary intention-to-treat analyses tested treatment effectiveness and were conducted using multilevel models to control for GP clustering and covariates for participants who completed questionnaire measures at baseline assessment plus at least one other assessment ( n = 873 ) .
RESULTS	analyses found significant differences between TC and UC on Short Form-12 mental component scores ( P < 0.05 ) , with parameter estimates indicating being a member of the TC trial-arm increases mental component scores ( UC-adjusted mean = 40.52 ; TC-adjusted mean = 43.69 ) .
RESULTS	Additional significant analyses revealed , time effects on EQ5D ( decreasing over time ) and depressive symptoms ( increasing over time ) .
CONCLUSIONS	TC potentially contributes to the amelioration in the decline in users ' mental HRQoL over a 12-month period .
CONCLUSIONS	TC may not transform the lives of its users , but it may afford small relative benefits on some psychological and HRQOL outcomes relative to users who only receive UC .
CONCLUSIONS	International Standard Randomised Controlled Trial Number Register : ISRCTN 43002091 .

###25588713
BACKGROUND	Choice of calcineurin inhibitor may influence response to antiviral therapy in liver transplant patients with hepatitis C virus ( HCV ) infection .
METHODS	In a randomized , multicenter , 80-week trial , liver transplant recipients ( > 6 months and 10 years post-transplant ) with recurrent HCV infection received cyclosporine ( n = 50 ) or tacrolimus ( n = 42 ) with a 48-week course of pegylated interferon ( peg-IFN2a ) and ribavirin .
METHODS	Twenty-three patients in each group completed the trial on study medication .
METHODS	The primary endpoint was sustained virological response ( SVR ) 24 weeks after the end of antiviral therapy , for which 43 patients were eligible for analysis .
RESULTS	The rate of SVR was 60.0 % ( 12/20 ) with cyclosporine and 43.5 % ( 10/23 ) with tacrolimus ( adjusted odds ratio 1.85 ; 95 % CI 0.53-6 .43 ; p = 0.331 ) .
RESULTS	There were no significant intergroup differences for rapid or early virological response , relapse , HCV RNA viral load , or fibrosis progression .
RESULTS	One cyclosporine-treated patient experienced acute rejection .
RESULTS	One patient died in each group .
RESULTS	Adverse events , treatment-related adverse events , and serious adverse events were similar between groups .
CONCLUSIONS	Since fewer patients were recruited than planned ( 92 versus 355 ) , the study was underpowered and robust conclusions can not be drawn regarding the effect of cyclosporine and tacrolimus on virological responses to antiviral treatment for recurrent HCV after liver transplantation .
CONCLUSIONS	However , as reported in other trials , SVR was higher in cyclosporine-treated patients .

###25879572
BACKGROUND	Overweight and obesity are major health problems worldwide .
BACKGROUND	This protocol describes the HEALTHI ( Healthy Eating and Active LifesTyle Health Intervention ) Program , a 12-week randomised-controlled weight-loss intervention that adopts two theory-based intervention techniques , mental imagery and implementation intentions , a behaviour-change technique based on planning that have been shown to be effective in promoting health-behaviour change in previous research .
BACKGROUND	The effectiveness of goal-reminder text messages to augment intervention effects will also be tested .
BACKGROUND	The trial will determine the effects of a brief , low cost , theory-based weight-loss intervention to improve dietary intake and physical activity behaviour and facilitate weight-loss in overweight and obese individuals .
METHODS	Overweight or obese participants will be randomly allocated to one of three conditions : ( 1 ) a psycho-education plus an implementation intentions and mental imagery condition ; ( 2 ) a psycho-education plus an implementation intentions and mental imagery condition with text messages ; or ( 3 ) a psycho-education control condition .
METHODS	The intervention will be delivered via video presentation to increase the intervention 's applicability in multiple contexts and keep costs low .
METHODS	We hypothesise that the intervention conditions will lead to statistically-significant changes in the primary and secondary outcome variables measured at 6 and 12 weeks post-intervention relative to the psycho-education control condition after controlling for baseline values .
METHODS	The primary outcome variable will be body weight and secondary outcome variables will be biomedical ( body mass , body fat percentage , muscle mass , waist-hip circumference ratio , systolic and diastolic blood pressure , low-density lipoprotein , high-density lipoprotein , total cholesterol , triglycerides , blood glucose and insulin levels ) , psychological ( quality of life , motivation , risk perception , outcome expectancy , intention , action self-efficacy , maintenance self-efficacy , goal setting and planning ) , and behavioural ( self-reported diet intake , and physical activity involvement ) measures .
METHODS	We also expect the intervention condition augmented with text messages to lead to statistically significant differences in the primary and secondary outcome variables at the follow up periods after controlling for baseline values .
CONCLUSIONS	The planned trial will test the effectiveness of the theory-based HEALTHI program intervention to reduce weight and salient psychological , biomedical , and behavioural outcomes in overweight and obese adults .
CONCLUSIONS	The study has been designed to maximise applicability to real world settings and could be integrated into existing weight management practices .
BACKGROUND	ACTRN : ACTRN12613001274763 .
BACKGROUND	Registration date 19/11/2013 .

###24909413
OBJECTIVE	To characterize the safety and efficacy of deep sedation ( DS ) as compared to general anaesthesia ( GA ) in percutaneous mitral valve repair ( PMVR ) using the MitraClip system .
BACKGROUND	PMVR with the MitraClip system has emerged as a therapeutic alternative to surgical valve repair in high-risk patients .
BACKGROUND	The PMVR procedure is typically performed under GA. .
BACKGROUND	Due to their high surgical risk , avoidance of GA in many of those patients would be desirable .
METHODS	In an open-label observational study 21 patients with severe mitral regurgitation were randomized to either GA or DS using propofol .
METHODS	Primary endpoints of this comparison were related to safety with rate of conversion from DS to GA , bleeding , aspiration , and pneumonia .
METHODS	Secondary endpoints were related to efficacy with procedural , in-hospital , and mid-term outcome at 1 month .
RESULTS	All clips have been implanted successfully in both groups .
RESULTS	No conversion from DS to GA was necessary .
RESULTS	Four patients undergoing GA suffered from upper respiratory tract infections and two from peripheral vascular complications during placement of central venous catheter for GA. .
RESULTS	Short - and mid-term efficacy were comparable in both groups with a reduced hospital stay in the DS group .
CONCLUSIONS	PVMR in high-risk patients performed under DS is as safe and effective as with GA , preventing complications related to GA and shortening hospital stay .

###24581940
BACKGROUND	The aim of this trial was to compare dose-escalated conformal radiotherapy with control-dose conformal radiotherapy in patients with localised prostate cancer .
BACKGROUND	Preliminary findings reported after 5 years of follow-up showed that escalated-dose conformal radiotherapy improved biochemical progression-free survival .
BACKGROUND	Based on the sample size calculation , we planned to analyse overall survival when 190 deaths occurred ; this target has now been reached , after a median 10 years of follow-up .
METHODS	RT01 was a phase 3 , open-label , international , randomised controlled trial enrolling men with histologically confirmed T1b-T3a , N0 , M0 prostate cancer with prostate specific antigen of less than 50 ng/mL .
METHODS	Patients were randomly assigned centrally in a 1:1 ratio , using a computer-based minimisation algorithm stratifying by risk of seminal vesicle invasion and centre to either the control group ( 64 Gy in 32 fractions , the standard dose at the time the trial was designed ) or the escalated-dose group ( 74 Gy in 37 fractions ) .
METHODS	Neither patients nor investigators were masked to assignment .
METHODS	All patients received neoadjuvant androgen deprivation therapy for 3-6 months before the start of conformal radiotherapy , which continued until the end of conformal radiotherapy .
METHODS	The coprimary outcome measures were biochemical progression-free survival and overall survival .
METHODS	All analyses were done on an intention-to-treat basis .
METHODS	Treatment-related side-effects have been reported previously .
METHODS	This trial is registered , number ISRCTN47772397 .
RESULTS	Between Jan 7 , 1998 , and Dec 20 , 2001 , 862 men were registered and 843 subsequently randomly assigned : 422 to the escalated-dose group and 421 to the control group .
RESULTS	As of Aug 2 , 2011 , 236 deaths had occurred : 118 in each group .
RESULTS	Median follow-up was 100 years ( IQR 91-108 ) .
RESULTS	Overall survival at 10 years was 71 % ( 95 % CI 66-75 ) in each group ( hazard ratio [ HR ] 099 , 95 % CI 077-128 ; p = 096 ) .
RESULTS	Biochemical progression or progressive disease occurred in 391 patients ( 221 [ 57 % ] in the control group and 170 [ 43 % ] in the escalated-dose group ) .
RESULTS	At 10 years , biochemical progression-free survival was 43 % ( 95 % CI 38-48 ) in the control group and 55 % ( 50-61 ) in the escalated-dose group ( HR 069 , 95 % CI 056-084 ; p = 00003 ) .
CONCLUSIONS	At a median follow-up of 10 years , escalated-dose conformal radiotherapy with neoadjuvant androgen deprivation therapy showed an advantage in biochemical progression-free survival , but this advantage did not translate into an improvement in overall survival .
CONCLUSIONS	These efficacy data for escalated-dose treatment must be weighed against the increase in acute and late toxicities associated with the escalated dose and emphasise the importance of use of appropriate modern radiotherapy methods to reduce side-effects .
BACKGROUND	UK Medical Research Council .

###24443035
OBJECTIVE	Pulmonary vein isolation ( PVI ) is an accepted treatment to relieve symptoms in patients with atrial fibrillation ( AF ) .
OBJECTIVE	We studied 3 year outcome after PVI guided by duty-cycled multi-electrode radiofrequency ( RF ) ablation ( pulmonary vein ablation catheter , PVAC ) and provided comparative data to outcome after conventional PVI ( CPVI ) using mapping with irrigated , point-per-point RF ablation .
RESULTS	One hundred and sixty-one consecutive patients with symptomatic paroxysmal or persistent AF and minimal heart disease underwent PVI ( PVAC , n = 79 vs. CPVI , n = 82 ) .
RESULTS	Follow-up ( with symptom-guided rhythm monitoring ) was truncated at 3 years in all patients .
RESULTS	Success was defined as freedom of documented arrhythmia after a single procedure and without antiarrhythmic drug treatment ( ADT ) .
RESULTS	Baseline characteristics did not differ between both groups .
RESULTS	At 3 years follow-up , single-procedure success without ADT was comparable between PVAC and CPVI ( 65 % vs. 55 % , P = NS ) .
RESULTS	The majority of recurrences occurred during the first year ( PVAC 79 % vs. CPVI 70 % , P = NS ) .
RESULTS	The annual rate of very late recurrence ( i.e. beyond 1 year ) was similar in both groups ( 10.5 % vs. 15 % , P = NS ) .
CONCLUSIONS	At 3 years follow-up , outcome after PVAC-guided PVI is comparable to conventional isolation by irrigated point-by-point RF ablation .
CONCLUSIONS	In both strategies , the majority of recurrences occurred in the first year of ablation .

###24977985
OBJECTIVE	The aim of this study was to determine the negative and positive agreement of a point-of-care matrix metalloproteinase-9 test in confirming the diagnosis of dry eye and to evaluate the ease of use by untrained ophthalmic technicians .
METHODS	The study was a prospective , sequential , masked , clinical trial with 4 clinical trial sites .
METHODS	The InflammaDry test was compared with the clinical assessment of tear break-up time , Schirmer tear testing , and corneal staining for the confirmation of dry eye , both with and without the inclusion of the Ocular Surface Disease Index ( OSDI ) , as a confirmatory test .
RESULTS	The study enrolled 237 patients .
RESULTS	If the OSDI is included in the definition for mild dry eye , the InflammaDry test was shown to have a total positive agreement of 81 % ( 127/157 ) and a negative agreement of 98 % ( 78/80 ) .
RESULTS	The removal of the OSDI shifted the categorization of 11 patients previously considered positive for dry eye to become categorized as negative for dry eye .
RESULTS	If the OSDI is excluded from the definition of dry eye , the InflammaDry test demonstrates a positive agreement of 86 % ( 126/146 ) and a negative agreement of 97 % ( 88/91 ) against the clinical assessment .
CONCLUSIONS	The InflammaDry test demonstrates a high positive and negative agreement for confirming suspected dry eye disease .
CONCLUSIONS	In addition , the test was safely and effectively performed by untrained operators .
CONCLUSIONS	These findings support the intended use of the InflammaDry test as an aid in the diagnosis of dry eye .

###25516991
BACKGROUND	Arterial puncture can be a painful procedure for many patients .
BACKGROUND	This study investigates whether precooling of a puncture site with ice can reduce the pain associated with arterial puncture .
METHODS	This was a stratified randomized controlled trial of a convenience sample of out-patients with a physician order for an arterial blood gas ( ABG ) test .
METHODS	The intervention group had a plastic bag of ice applied to their wrists for 3 min before drawing an ABG sample from the radial artery .
METHODS	The control group had an ABG sample drawn from the radial artery without the application of ice .
METHODS	Pain from the arterial puncture was measured with a 100-mm visual analog scale .
RESULTS	Subjects pretreated with ice reported less pain from arterial puncture compared with subjects in the control group ( mean visual analog scale 13.8 16.9 vs 25 23 mm , P = .01 ; median visual analog scale 7 mm , interquartile range ( IQR ) 1.5-19 vs 20 mm , IQR 4.5-38 .5 mm , P = .01 ) .
RESULTS	Stratified analysis showed that visual analog scale pain scores were lower in the naive group when ice was applied ( naive ice vs naive control : mean visual analog scale 11 14.3 vs 26.5 25 mm , P = .02 ; median visual analog scale 5 mm , IQR 2-14 .5 vs 20 mm , IQR 6.5-36 mm , P = .02 ) .
RESULTS	Visual analog scale pain scores trended lower in the experienced group when ice was applied ( experienced ice vs experienced control : mean visual analog scale 15.9 18.9 vs 25.1 22 mm , P = .15 ; median visual analog scale 8 mm , IQR 0.5-26 .5 vs 23 mm , IQR 3.5-40 mm , P = .08 ) .
RESULTS	There was no difference in first-attempt success between groups ( ice group : 85 % , control group : 82.5 % , P > .99 ) .
RESULTS	Only 3 subjects could not tolerate 3-min ice application .
CONCLUSIONS	Ice application before arterial puncture is well tolerated and reduces procedure-related pain .
CONCLUSIONS	( ClinicalTrials.gov NCT02065115 ) .

###24602553
OBJECTIVE	Melatonin levels decrease physiologically with age , and possibly with the transition to menopause .
OBJECTIVE	The plausible influence of hormone therapy ( HT ) on melatonin is poorly understood .
OBJECTIVE	The aim of this randomized , placebo-controlled , double-blind trial was to investigate the effect of HT administration on serum melatonin concentrations in late premenopausal and postmenopausal women .
METHODS	Analyses were carried out among 17 late premenopausal and 18 postmenopausal healthy women who participated in a prospective HT study in Finland .
METHODS	Serum melatonin was sampled at 20-min ( 21:00 -24:00 h ; 06:00 -09:00 h ) and 1-h ( 24:00 -06:00 h ) intervals at baseline and after 6 months with HT or placebo .
METHODS	Melatonin levels and secretion profile after 6 months of HT compared to placebo .
RESULTS	Mean melatonin levels , mean melatonin exposure level ( area under curve , AUC ) and mean duration of melatonin secretion did not differ after 6 months with HT vs. placebo , irrespectively of the reproductive state .
RESULTS	However , in postmenopausal women the melatonin peak time ( acrophase ) was delayed by 2.4 h ( 2 h 21 min ) on average after 6 months with HT vs. placebo ( p < 0.05 ) .
RESULTS	No interaction between time and group was detected when melatonin level was modelled before or after treatment .
CONCLUSIONS	Administration of HT to postmenopausal women alters melatonin peak time , but not melatonin levels .
CONCLUSIONS	Further research on larger clinical samples is needed to better understand the effects of HT on melatonin profile .

###24676963
BACKGROUND	There is good evidence for the benefits of short-term cognitive stimulation therapy for dementia but little is known about possible long-term effects .
OBJECTIVE	To evaluate the effectiveness of maintenance cognitive stimulation therapy ( CST ) for people with dementia in a single-blind , pragmatic randomised controlled trial including a substudy with participants taking acetylcholinesterase inhibitors ( AChEIs ) .
METHODS	The participants were 236 people with dementia from 9 care homes and 9 community services .
METHODS	Prior to randomisation all participants received the 7-week , 14-session CST programme .
METHODS	The intervention group received the weekly maintenance CST group programme for 24 weeks .
METHODS	The control group received usual care .
METHODS	Primary outcomes were cognition and quality of life ( clinical trial registration : ISRCTN26286067 ) .
RESULTS	For the intervention group at the 6-month primary end-point there were significant benefits for self-rated quality of life ( Quality of Life in Alzheimer 's Disease ( QoL-AD ) P = 0.03 ) .
RESULTS	At 3 months there were improvements for proxy-rated quality of life ( QoL-AD P = 0.01 , Dementia Quality of Life scale ( DEMQOL ) P = 0.03 ) and activities of daily living ( P = 0.04 ) .
RESULTS	The intervention subgroup taking AChEIs showed cognitive benefits ( on the Mini-Mental State Examination ) at 3 ( P = 0.03 ) and 6 months ( P = 0.03 ) .
CONCLUSIONS	Continuing CST improves quality of life ; and improves cognition for those taking AChEIs .

###24592967
BACKGROUND	Physical inactivity and a poor diet predict lifestyle diseases such as diabetes , cardiovascular disease , and certain types of cancer .
BACKGROUND	Marked declines in physical activity occur during late adolescence , coinciding with the point at which many young people leave school and enter the workforce and begin to take greater control over their lifestyle behaviours .
BACKGROUND	The work outlined within this paper sought to test a theoretically-informed intervention aimed at supporting increased engagement in physical activity and healthy eating habits in young people at the point of transition from school to work or work-based learning .
BACKGROUND	As actively engaging young people in initiatives based on health messages is challenging , we also tested the efficacy of financial incentives in promoting initial engagement with the programme .
METHODS	A three-arm cluster-randomised design was used .
METHODS	Participants were school pupils from Year 11 and 13 ( i.e. , in their final year of study ) , aged 16-18years .
METHODS	To reduce contamination effects , the unit of randomisation was school .
METHODS	Participants were randomly allocated to receive ( i ) a 12-week behavioural support intervention consisting of six appointments , ( ii ) a behavioural support intervention plus incentives ( totalling 40 ) , or ( iii ) an information-only control group .
METHODS	Behavioural support was provided by fitness advisors at local leisure centres following an initial consultation with a dietician .
METHODS	Sessions focused on promoting habit formation through setting implementation intentions as part of an incremental goal setting process .
METHODS	Consistent with self-determination theory , all advisors were trained to provide guidance in an autonomy-supportive manner so that they were equipped to create a social context supportive of autonomous forms of participant motivation .
METHODS	The primary outcome was objectively assessed physical activity ( via GT1M accelerometers ) .
METHODS	Secondary outcome measures were diet , motivation and habit strength .
METHODS	Data were collected at baseline , post-intervention ( 12weeks ) and 12months .
CONCLUSIONS	Findings of this trial will provide valuable insight into the feasibility of promoting autonomous engagement in healthy physical activity and dietary habits among school leavers .
CONCLUSIONS	The research also provides much needed data and detailed information related to the use of incentives for the initial promotion of young peoples ' behaviour change during this important transition .
BACKGROUND	The trial is registered as Current Controlled Trials ISRCTN55839517 .

###25509693
BACKGROUND	Hepatitis C virus ( HCV ) infection is associated with chronic inflammation and oxidative damage , with hepatic steatosis being common in genotype 3 cases .
BACKGROUND	Vitamin E , a potent antioxidant protective against oxidative stress-induced liver damage in vitro and in vivo , has beneficial effects on alanine aminotransferase ( ALT ) and histological outcomes in patients with non-alcoholic steatohepatitis .
OBJECTIVE	To assess the effect of vitamin E on ALT status in patients with HCV genotype 3 .
METHODS	This randomized , placebo-controlled , double-blind trial was conducted in a single tertiary-care hospital ( Rajavithi Hospital , Bangkok ) between 2010 and 2011 .
METHODS	We included patients with HCV genotype 3 infection , unable to receive or tolerate , or did not respond to standard therapy .
METHODS	Responders were defined as patients exhibiting a decrease in serum ALT of at least 5 % below the baseline value after 12 weeks of treatment .
RESULTS	Thirty-seven eligible patients were randomly assigned either to receive vitamin E 400 IU twice daily ( n = 19 ) or placebo ( n = 18 ; 1 dropped outearly ) for 12 weeks .
RESULTS	In all , 11 of 19 patients in the vitamin E group ( 57.8 % ) and 5 of 17 patients in the placebo group ( 29.4 % ) were ALT responders .
RESULTS	Among responders , serum ALT levels were greatly decreased in the vitamin E group ( reducing from 122.680.1 IU/L to 68.425.3 IU/L , p = 0.016 ) , when compared with the placebo group ( reducing from 89.240.6 IU/L to 73.630.6 IU/L , p > 0.05 ) .
RESULTS	Vitamin E treatment was well-tolerated with no serious adverse events in the present study .
CONCLUSIONS	Vitamin E treatment decreased serum ALT levels in patients with HCV genotype 3 .
CONCLUSIONS	Because of its good safety profile , vitamin E may be a worthwhile supportive therapy for patients with HCV particularly for those who were unable to achieve viral eradication by standard therapy .

###24552977
OBJECTIVE	Two phase 3 , randomized , placebo-controlled trials demonstrated that low-dose paroxetine 7.5 mg reduced the frequency and severity of vasomotor symptoms ( VMS ) associated with menopause and had a favorable tolerability profile .
OBJECTIVE	The impact of paroxetine 7.5 mg on body weight and sexual function was evaluated in a pooled analysis .
METHODS	Postmenopausal women aged 40 years or older who had moderate to severe VMS were randomly assigned to receive paroxetine 7.5 mg or placebo once daily for 12 or 24 weeks .
METHODS	Assessments included changes in body mass index ( BMI ) and weight , Arizona Sexual Experiences Scale score , Hot Flash-Related Daily Interference Scale sexuality subscore , and adverse events related to weight or sexual dysfunction .
RESULTS	Pooled efficacy and safety populations comprised 1,174 and 1,175 participants , respectively .
RESULTS	Baseline values were similar for median weight ( 75 kg ) , median BMI ( 28 kg/m ) , and the proportion of women with sexual dysfunction ( 58 % ) .
RESULTS	No clinically meaningful or statistically significant changes from baseline in weight or sexual function assessments occurred in the paroxetine 7.5 mg group .
RESULTS	Small but statistically significant increases in weight and BMI were observed in the placebo group only on week 4 .
RESULTS	No significant difference between treatment groups was observed in the proportion of participants who had 7 % or higher gain in body weight on week 4 , 12 , or 24 .
RESULTS	Rates of adverse events suggestive of sexual dysfunction were low and similar in both treatment groups .
CONCLUSIONS	Paroxetine 7.5 mg does not cause weight gain or negative changes in libido when used to treat menopause-associated VMS in postmenopausal women .

###25873233
BACKGROUND	Some symptomatic degenerative conditions of the lumbar spine may be treated with spinal fusion if conservative treatment has failed .
BACKGROUND	The minimally invasive technique of transforaminal lumbar interbody fusion ( MIS TLIF ) is increasingly used but has been found to generate increased radiation exposure to the patient and staff .
BACKGROUND	Modern three-dimensional ( 3D ) C-arm devices are capable of providing conventional two-dimensional fluoroscopic images ( x-rays ) as well as 3D image sets for intraoperative navigation .
BACKGROUND	This study was designed to compare the radiation exposure between these two intraoperative imaging techniques in MIS TLIF procedures .
METHODS	This study is a randomized controlled trial .
METHODS	Forty participants scheduled to undergo monosegmental MIS TLIF will be recruited and randomly allocated to one of two groups with respect to the applied intraoperative imaging technique : conventional fluoroscopy ( FLUORO group ) and 3D fluoroscopy-based navigation combined with conventional fluoroscopy ( NAV group ) .
METHODS	Furthermore , patients scheduled to undergo bisegmental MIS TLIF during the recruitment period for monosegmental MIS TLIF will be assessed for eligibility and will be randomly assigned separately .
METHODS	The primary endpoint is the radiation exposure to the surgeon and is measured by dosimeter readings .
METHODS	Secondary endpoints are the radiation exposure to the assistant surgeon , scrub nurse , anesthetist , patient , and C-arm as well as radiation exposure in relation to the body mass index of the patient .
CONCLUSIONS	Results of this randomized study will help to compare the radiation exposure to the operating staff and patient during MIS TLIF procedures using conventional fluoroscopy versus 3D fluoroscopy-based navigation combined with conventional fluoroscopy .
CONCLUSIONS	Furthermore , recommendations regarding the appropriate use of the investigated intraoperative imaging techniques will be made to improve radiation protection and to reduce radiation exposure .
BACKGROUND	Registration number of the German Clinical Trials Register : DRKS00004514 .
BACKGROUND	Registration date : 11 August 2012 .

###24716390
OBJECTIVE	The purpose of the study was to examine the relationship between ( 1 ) critical care nurses ' information-seeking behaviour and the non-routineness of tasks ; and ( 2 ) the extent to which nurses ' perception of their problem-solving abilities when completing patient care tasks , moderate the relationship between information-seeking behaviour and non-routineness of tasks .
METHODS	A cross-sectional survey design was used .
METHODS	A random sample ( n = 177 ) of critical care nurses working in hospital settings was selected from the College of Nurses of Ontario ( CNO ) database .
METHODS	Descriptive statistics and multiple regression were used to analyze the data .
RESULTS	Previous information-seeking training ( p = 0.008 ) , non-routineness of the task ( p = 0.018 ) , and the perception of the problem-solving ability domain of personal control ( p = 0.040 ) had positive relationships with information-seeking behaviour .
CONCLUSIONS	The development of problem-solving skills such as personal control , in addition to information-seeking training is essential so critical care nurses will have the skills to aid their information needs when faced with the completion of non-routine tasks .

###25311321
BACKGROUND	Current guidelines for transcutaneous oximetry measurement ( TCOM ) for the lower limb define tissue hypoxia as a transcutaneous oxygen partial pressure < 40 mmHg .
BACKGROUND	Values obtained with some newer machines and current research bring these reference values into question .
OBJECTIVE	To determine ` normal ' TCOM values for the lower limb in healthy , non-smoking adults using the TCM400 oximeter with tc Sensor E5250 .
METHODS	Thirty-two healthy , non-smoking volunteers had TCOM performed at six positions on the lower leg and foot .
METHODS	Measurements were taken with subjects lying supine breathing air , then with leg elevated and whilst breathing 100 % oxygen .
RESULTS	Room-air TCOM values ( mean mmHg , 95 % confidence interval ( CI ) ) were : lateral leg 41.3 , CI 37.8 to 44.7 ; lateral malleolus 38.6 , CI 34.1 to 43.1 ; medial malleolus 43.9 , CI 40.2 to 47.6 ; dorsum , between first and second toe 39.3 , CI 35.9 to 42.7 ; dorsum , proximal to fifth metatarsal-phalangeal joint 46.4 , CI 43.4 to 49.3 ; plantar 52.3 , CI 49.6 to 55.1 .
RESULTS	Using the currently accepted value of less than 40 mmHg for tissue hypoxia , 24 of our 32 ` healthy ' subjects had at least one air sensor reading that would have been classified as hypoxic .
RESULTS	Seventeen subjects had TCOM values less than 100 mmHg when breathing 100 % normobaric oxygen .
CONCLUSIONS	Normal lower limb TCOM readings using the TCOM400 with tc Sensor E5250 may be lower than 40 mmHg , used to define tissue hypoxia , but consistent with the wide range of values found in the literature .
CONCLUSIONS	Because of the wide variability in TCOM at the different sensor sites we can not recommend one TCOM value as indicative of tissue hypoxia .
CONCLUSIONS	A thorough clinical assessment of the patient is essential to establish appropriateness for hyperbaric oxygen treatment , with TCOM used as an aid to help guide this decision , but not as an absolute diagnostic tool .

###25580916
OBJECTIVE	According to the proposed interference of N-acetylcysteine ( NAC ) with pathophysiologic processes of autistic disorders ( ADs ) , we aimed to assess the effectiveness and safety of NAC as an adjunct to risperidone in the treatment of ADs in a randomized , double-blind , clinical trial .
METHODS	The participants were referred outpatients between 4 and 12 years of age with the diagnosis of ADs and a score of more than 12 on Aberrant Behavior Checklist-Community ( ABC-C ) Irritability subscale score .
METHODS	The participants were randomized into 2 groups .
METHODS	One group received risperidone plus NAC , and the other group received risperidone plus placebo .
METHODS	The dose of risperidone was titrated between 1 and 2.0 mg/d , and the dose of NAC was 600 to 900 mg/d .
METHODS	The main outcome was mean decrease in the ABC-C irritability subscale score from baseline at 5 and 10 weeks .
METHODS	Changes in other subscales were considered as secondary outcome measures .
RESULTS	Forty patients completed the 10-week trial .
RESULTS	Baseline characteristics including age , sex and body weight , as well as baseline scores in 5 subscales did not demonstrate statistically significant difference between the 2 groups .
RESULTS	Repeated-measures analysis showed significant effect for time treatment interaction in irritability ( P = 0.01 ) and hyperactivity/noncompliance ( P = 0.02 ) subscales .
RESULTS	By week 10 , the NAC group showed significantly more reduction in irritability ( P = 0.02 ) and hyperactivity/noncompliance ( P = 0.01 ) subscales scores .
CONCLUSIONS	N-acetylcysteine can be considered as an adjuvant therapy for ADs with beneficial therapeutic outcomes .

###24911369
OBJECTIVE	To determine the variability in treatment responses to antiemetic therapy ( ondansetron and dexamethasone vs ondansetron and dexamethasone plus aprepitant ) given with moderately emetogenic chemotherapy .
METHODS	Post hoc subgroup analysis of data from a phase III , randomized , double-blind clinical trial evaluated whether the efficacy of aprepitant triple therapy ( ondansetron and dexamethasone plus aprepitant ) versus control ( ondansetron and dexamethasone ) varies by gender , age , or region in 848 men and women 18 years old with histologically confirmed malignancies and who were nave to moderately or highly emetogenic chemotherapeutic agents .
METHODS	Endpoints compared were the incidences of no vomiting , complete response , and no use of rescue therapy , all during the overall period ( 0-120h ) .
METHODS	Regardless of age , gender , or region , the aprepitant regimen provided better control for the no-vomiting and complete-response ( no vomiting , no rescue therapy ) endpoints .
RESULTS	The aprepitant regimen provided better control for the no-vomiting and complete-response ( no vomiting , no rescue therapy ) endpoints .
RESULTS	Overall response rates were higher in men and in older ( 55y ) patients , but treatment differences were greater among women and younger patients , known to be at increased chemotherapy-induced nausea and vomiting ( CINV ) risk .
RESULTS	Aprepitant showed a benefit versus control across regions , although the between-treatment difference appeared to be smaller for patients in Central/South America versus North America or international regions .
CONCLUSIONS	Although we acknowledge that subset numbers in this post hoc analysis may be too small to allow definitive conclusions , the data suggest that aprepitant triple therapy provides a benefit over control therapy for the prevention of CINV in patients receiving anthracycline and cyclophosphamide ( AC ) - or non-AC-based moderately emetogenic chemotherapy across age , gender , and region .
CONCLUSIONS	( Original trial results available at ClinicalTrials.gov : NCT00337727 . )

###25407279
BACKGROUND	The - aminobutyric acid type B-receptor agonist lesogaberan ( AZD3355 ) has been developed for use in patients with gastroesophageal reflux disease ( GERD ) symptoms despite proton pump inhibitor ( PPI ) therapy ( partial responders ) .
BACKGROUND	This study aimed to explore the dose-response effect of lesogaberan on reflux episodes in partial responders .
METHODS	In this randomized , single-centre , double-blind , crossover , placebo-controlled study , partial responders taking optimised PPI therapy were given 30 , 90 , 120 and 240mg doses of lesogaberan .
METHODS	Each dose was given twice ( 12h apart ) during a 24-h period , during which impedance-pH measurements were taken .
RESULTS	Twenty-five patients were included in the efficacy analysis and 27 in the safety analysis .
RESULTS	The effect of lesogaberan on the mean number of reflux episodes was dose-dependent , and all doses significantly reduced the mean number of reflux episodes relative to placebo .
RESULTS	Lesogaberan also dose-dependently reduced the mean number of acid reflux episodes ( except the 30mg dose ) and weakly acid reflux episodes ( all doses ) significantly , relative to placebo .
RESULTS	Regardless of dose , lesogaberan had a similar effect on the percentage of time with esophageal pH < 4 [ mean reduction : 68.5 % ( 30mg ) , 54.2 % ( 90mg ) , 65.9 % ( 120mg ) , 72.1 % ( 240mg ) ; p < 0.05 except 90mg dose ] .
RESULTS	No adverse events led to discontinuation and no serious adverse events occurred during active treatment .
CONCLUSIONS	Lesogaberan inhibited reflux in a dose-dependent manner in partial responders taking optimised PPI therapy , and these effects were significant versus placebo .
CONCLUSIONS	All lesogaberan doses were well tolerated and were not associated with clinically relevant adverse events .
BACKGROUND	ClinicalTrials.gov identifier : NCT01043185 .

###24633934
OBJECTIVE	The study was conducted to explore the effects of EGb 761 ( Dr. Willmar Schwabe GmbH & Co. .
OBJECTIVE	KG , Karlsruhe , Germany ) on neuropsychiatric symptoms ( NPS ) and cognition in patients with mild cognitive impairment ( MCI ) .
METHODS	One hundred and sixty patients with MCI who scored at least 6 on the 12-item Neuropsychiatric Inventory ( NPI ) were enrolled in this double-blind , multi-center trial and randomized to receive 240mg EGb 761 daily or placebo for a period of 24weeks .
METHODS	Effects on NPS were assessed using the NPI , the state sub-score of the State-Trait Anxiety Inventory and the Geriatric Depression Scale .
METHODS	Further outcome measures were the Trail-Making Test ( A/B ) for cognition and global ratings of change .
METHODS	Statistical analyses followed the intention-to-treat principle .
RESULTS	The NPI composite score decreased by 7.04.5 ( mean , standard deviation ) points in the EGb 761-treated group and by 5.55.2 in the placebo group ( p = 0.001 ) .
RESULTS	Improvement by at least 4 points was found in 78.8 % of patients treated with EGb 761 and in 55.7 % of those receiving placebo ( p = 0.002 ) .
RESULTS	Superiority of EGb 761 over placebo ( p < 0.05 ) was also found for the State-Trait Anxiety Inventory score , the informants ' global impression of change , and both Trail-Making Test scores .
RESULTS	There were statistical trends favoring EGb 761 in the Geriatric Depression Scale and the patients ' global impression of change .
RESULTS	Adverse events ( all non-serious ) were reported by 37 patients taking EGb 761 and 36 patients receiving placebo .
CONCLUSIONS	EGb 761 improved NPS and cognitive performance in patients with MCI .
CONCLUSIONS	The drug was safe and well tolerated .

###24760977
BACKGROUND	Ghrelin , which is a stomach-derived hormone , increases with fasting and energy restriction and may influence eating behaviors through brain hedonic reward-cognitive systems .
BACKGROUND	Therefore , changes in plasma ghrelin might mediate counter-regulatory responses to a negative energy balance through changes in food hedonics .
OBJECTIVE	We investigated whether ghrelin administration ( exogenous hyperghrelinemia ) mimics effects of fasting ( endogenous hyperghrelinemia ) on the hedonic response and activation of brain-reward systems to food .
METHODS	In a crossover design , 22 healthy , nonobese adults ( 17 men ) underwent a functional magnetic resonance imaging ( fMRI ) food-picture evaluation task after a 16-h overnight fast ( Fasted-Saline ) or after eating breakfast 95 min before scanning ( 730 kcal , 14 % protein , 31 % fat , and 55 % carbohydrate ) and receiving a saline ( Fed-Saline ) or acyl ghrelin ( Fed-Ghrelin ) subcutaneous injection before scanning .
METHODS	One male subject was excluded from the fMRI analysis because of excess head motion , which left 21 subjects with brain-activation data .
RESULTS	Compared with the Fed-Saline visit , both ghrelin administration to fed subjects ( Fed-Ghrelin ) and fasting ( Fasted-Saline ) significantly increased the appeal of high-energy foods and associated orbitofrontal cortex activation .
RESULTS	Both fasting and ghrelin administration also increased hippocampus activation to high-energy - and low-energy-food pictures .
RESULTS	These similar effects of endogenous and exogenous hyperghrelinemia were not explicable by consistent changes in glucose , insulin , peptide YY , and glucagon-like peptide-1 .
RESULTS	Neither ghrelin administration nor fasting had any significant effect on nucleus accumbens , caudate , anterior insula , or amygdala activation during the food-evaluation task or on auditory , motor , or visual cortex activation during a control task .
CONCLUSIONS	Ghrelin administration and fasting have similar acute stimulatory effects on hedonic responses and the activation of corticolimbic reward-cognitive systems during food evaluations .
CONCLUSIONS	Similar effects of recurrent or chronic hyperghrelinemia on an anticipatory food reward may contribute to the negative impact of skipping breakfast on dietary habits and body weight and the long-term failure of energy restriction for weight loss .

###24392599
OBJECTIVE	To explore the impact of race/ethnicity on efficacy and safety of twice-daily insulin lispro mix 75/25 ( LM75/25 ; 75 % lispro protamine suspension , 25 % insulin lispro ) and once daily insulin glargine ( GL ) .
METHODS	More than 2,000 Patients with type 2 diabetes enrolled in the 24-week initiation phase of the DURABLE Trial .
METHODS	Efficacy and safety variables at endpoint , including hemoglobin A1c ( HbA1c ) , self-monitored plasma glucose ( SMPG ) , and hypoglycemia , in each racial/ethnic group were compared to Caucasians within treatment groups .
RESULTS	Asian patients had less ( LM75/25 : -1.46 % , P < .01 ; GL : -1.25 % , P < .01 ) and Hispanic patients had greater ( LM75/25 : -2.17 % ) HbA1c reduction from baseline vs Caucasian patients ( LM75/25 : -1.84 % ; GL : -1.78 % ) .
RESULTS	Fewer Asian ( LM75/25 : 20 % , P < .001 ; GL : 22 % , P < .001 ) and Hispanic patients ( LM75/25 : 40 % , P < .01 ) reached HbA1c target ( < 7 % ) vs Caucasian patients ( LM75/25 : 53 % ; GL : 44 % ) .
RESULTS	Fasting plasma glucose was similar among groups , postprandial glucose ( PPG ) with GL was lower for African patients post-breakfast and post-dinner and higher for Asian patients post-lunch .
RESULTS	Only PPG with LM75/25 was lower for Hispanic patients post-breakfast .
RESULTS	Weight gain was lower in Asian patients ( LM75 / 25 ) .
RESULTS	Insulin dose was higher for Asian ( LM75/25 and GL ) and lower for African patients ( GL ) .
RESULTS	Hypoglycemia rate was lower for Asian ( LM75/25 and GL ) and Hispanic patients ( LM75/25 ) .
CONCLUSIONS	There were significant efficacy and safety differences among racial/ethnic groups in the DURABLE trial .
CONCLUSIONS	These differences may be important in designing insulin based treatment plans .

###25415549
OBJECTIVE	Evidence suggests that the use of stimulation to increase corticomotor excitability improves hand function in persons with cervical spinal cord injury .
OBJECTIVE	We assessed effects of a multiday application of 10-Hz repetitive transcranial magnetic stimulation ( rTMS ) applied to the corticomotor hand area combined with repetitive task practice ( RTP ) in participants with tetraplegia and neurologically healthy participants .
METHODS	Using a double-blind , randomized , crossover design , 11 participants with chronic tetraplegia and 10 neurologically healthy participants received 3 sessions of 10-Hz rTMS + RTP and 3 sessions of sham-rTMS + RTP to the corticomotor hand region controlling the weaker hand .
METHODS	Repetitive transcranial magnetic stimulation was interleaved with RTP of a skilled motor task between pulse trains .
METHODS	Hand function ( Jebsen-Taylor Hand Function Test , pinch , and grasp strength ) and corticomotor excitability ( amplitude of motor-evoked potential ) were assessed before and after the rTMS + RTP and sham-rTMS + RTP phases .
METHODS	We assessed significance , using paired t tests on pre-post differences , and effect sizes , using the standardized response mean .
RESULTS	RTMS+RTP was associated with larger effect sizes compared with sham-rTMS + RTP for improvement in Jebsen-Taylor Hand Function Test for both the trained hand ( standardized response mean = 0.85 and 0.42 , respectively ) and non-trained hand ( 0.55 and 0.31 , respectively ) , and for grasp strength of the trained hand in the group with cervical spinal cord injury ( 0.67 and 0.39 , respectively ) alone .
RESULTS	Effect sizes for all other measures were small and there were no statistical between-condition differences in the outcomes assessed .
CONCLUSIONS	Repetitive transcranial magnetic stimulation may be a valuable adjunct to RTP for improving hand function in persons with tetraplegia .
CONCLUSIONS	Higher stimulation dose ( frequency , intensity , and the number of sessions ) may be associated with larger effects .
BACKGROUND	( see Supplemental Digital Content 1 , http://links.lww.com/JNPT/A82 ) for more insights from the authors .

###24240932
OBJECTIVE	Obesity is a risk factor for atrial fibrillation .
OBJECTIVE	Whether weight reduction and cardiometabolic risk factor management can reduce the burden of atrial fibrillation is not known .
OBJECTIVE	To determine the effect of weight reduction and management of cardiometabolic risk factors on atrial fibrillation burden and cardiac structure .
METHODS	Single-center , partially blinded , randomized controlled study conducted between June 2010 and December 2011 in Adelaide , Australia , among overweight and obese ambulatory patients ( N = 150 ) with symptomatic atrial fibrillation .
METHODS	Patients underwent a median of 15 months of follow-up .
METHODS	Patients were randomized to weight management ( intervention ) or general lifestyle advice ( control ) .
METHODS	Both groups underwent intensive management of cardiometabolic risk factors .
METHODS	The primary outcomes were Atrial Fibrillation Severity Scale scores : symptom burden and symptom severity .
METHODS	Scores were measured every 3 months from baseline to 15 months .
METHODS	Secondary outcomes performed at baseline and 12 months were total atrial fibrillation episodes and cumulative duration measured by 7-day Holter , echocardiographic left atrial area , and interventricular septal thickness .
RESULTS	Of 248 patients screened , 150 were randomized ( 75 per group ) and underwent follow-up .
RESULTS	The intervention group showed a significantly greater reduction , compared with the control group , in weight ( 14.3 and 3.6 kg , respectively ; P < .001 ) and in atrial fibrillation symptom burden scores ( 11.8 and 2.6 points , P < .001 ) , symptom severity scores ( 8.4 and 1.7 points , P < .001 ) , number of episodes ( 2.5 and no change , P = .01 ) , and cumulative duration ( 692-minute decline and 419-minute increase , P = .002 ) .
RESULTS	Additionally , there was a reduction in interventricular septal thickness in the intervention and control groups ( 1.1 and 0.6 mm , P = .02 ) and left atrial area ( 3.5 and 1.9 cm2 , P = .02 ) .
CONCLUSIONS	In this study , weight reduction with intensive risk factor management resulted in a reduction in atrial fibrillation symptom burden and severity and in beneficial cardiac remodeling .
CONCLUSIONS	These findings support therapy directed at weight and risk factors in the management of atrial fibrillation .
BACKGROUND	anzctr.org.au Identifier : ACTRN12610000497000 .

###24271137
OBJECTIVE	To evaluate whether evacetrapib prolongs QT intervals in healthy participants .
METHODS	This was a single-center , randomized , active and placebo-controlled , 3-period , 6-sequence , and crossover study .
METHODS	Participants were randomized to 1 of 6 treatment sequences in which they received 1 of 3 treatments : evacetrapib 1200 mg daily for 10 days ( supratherapeutic dose ) , moxifloxacin 400 mg for 1 day ( positive control ) , or placebo for 10 days in each of the 3 separate treatment periods .
METHODS	Electrocardiographic parameters were recorded at time points specified in the protocol .
METHODS	The primary end point was the comparison of evacetrapib effect on the population-corrected QT interval ( QTcP ) to that of placebo at 7 time points following dosing on day 10 .
METHODS	An upper limit of the 2-sided 90 % confidence interval ( CI ) < 10 milliseconds confirmed the absence of significant effect .
METHODS	Pharmacokinetic parameters were also calculated .
RESULTS	Subjects were predominantly male ( 73.2 % ) with a mean age of 43.1 years and a mean body mass index of 25.9 kg/m ( 2 ) .
RESULTS	For the primary analysis , the upper bound of the 2-sided 90 % CI for the mean difference between evacetrapib and placebo was < 10 milliseconds at all time points on day 10 .
RESULTS	Following administration of moxifloxacin , the QTcP increased by 5 milliseconds at all time points ( 2 , 3 , and 4 hours postdose ) .
RESULTS	Maximum plasma concentrations of evacetrapib occurred at a median time of approximately 2 hours , and the mean apparent elimination half-life was approximately 41 hours .
RESULTS	The area under the curve and Cmax achieved in this study were both 5-fold the values that are expected with the dose level being studied in a phase 3 cardiovascular outcome study .
RESULTS	A 1200-mg supratherapeutic dose of evacetrapib was considered to be well tolerated after 10 days of daily dosing in healthy participants .
CONCLUSIONS	Evacetrapib is not associated with QT interval prolongation , even at supratherapeutic doses .

###25885650
BACKGROUND	A small literature suggests that pharmacotherapy may be useful in the prophylaxis of posttraumatic stress disorder in patients presenting with major trauma .
BACKGROUND	There is relatively little data , however , on the use of selective serotonin reuptake inhibitors ( SSRIs ) in this context .
METHODS	24 week , double-blind placebo controlled study .
METHODS	31 participants presenting immediately after trauma , and meeting diagnostic criteria for full or partial acute stress disorder were randomized to treatment with 10-20 mg of escitalopram or placebo daily for 24 weeks .
METHODS	2 participants were excluded from the analysis due to early drop out , leaving 29 participants ( escitalopram = 12 , placebo = 17 ) for inclusion in an intent - to - treat analysis .
METHODS	Participants were followed up until 56 weeks , and assessed with the Clinician Administered PTSD Scale ( CAPS ) .
METHODS	A mixed model repeated measures analysis of variance ( RMANOVA ) was undertaken to determine the efficacy of the intervention on the CAPS score .
RESULTS	There was a significant reduction in CAPS score over the course of treatment ( F ( 7 , 142 ) = 41.58 , p < 0.001 ) in both the escitalopram and placebo groups , with a greater reduction in CAPS score in the placebo group F ( 7 , 142 ) = 2.12 , p = 0.045 .
RESULTS	There were improvements on all secondary measures , including the Clinical Global Impressions scale , and scales assessing depression , anxiety and disability .
RESULTS	Only functional disability outcomes ( F ( 7 , 141 ) = 2.13 , p = .04 ) , were significantly different between treatment and placebo groups .
RESULTS	In the sample as a whole , improvement in scores were maintained at the 52 week follow-up .
RESULTS	Side effects were comparable between the groups .
CONCLUSIONS	These data are consistent with other recent work indicating that the SSRIs may not be efficacious in the prevention of PTSD .
CONCLUSIONS	Nevertheless , the small sample size and baseline differences between groups limit the explanatory power of the study .
CONCLUSIONS	Although a consideration of the possibility of medication prophylaxis in PTSD remains important , both from conceptual and clinical perspectives , caution is needed with regards to the use of SSRIs until their efficacy can be proven .
BACKGROUND	Clinical Trials NCT00300313 .

###25393622
BACKGROUND	Prevention of rejection after renal transplantation requires treatment with immunosuppressive drugs .
BACKGROUND	Data on their in vivo effects on T - and B-cell phenotype and function are limited .
METHODS	In a randomized double-blind placebo-controlled study to prevent renal allograft rejection , patients were treated with tacrolimus , mycophenolate mofetil ( MMF ) , steroids , and a single dose of rituximab or placebo during transplant surgery .
METHODS	In a subset of patients , we analyzed the number and phenotype of peripheral T and B cells by multiparameter flow cytometry before transplantation , and at 3 , 6 , 12 , and 24 months after transplantation .
RESULTS	In patients treated with tacrolimus/MMF/steroids the proportion of central memory CD4 + and CD8 + T cells was higher at 3 months post-transplant compared to pre-transplant levels .
RESULTS	In addition , the ratio between the percentage of central memory CD4 + and CD4 + regulatory T cells was significantly higher up to 24 months post-transplant compared to pre-transplant levels .
RESULTS	Interestingly , treatment with tacrolimus/MMF/steroids resulted in a shift toward a more memory-like B-cell phenotype post-transplant .
RESULTS	Addition of a single dose of rituximab resulted in a long-lasting B-cell depletion .
RESULTS	At 12 months post-transplant , the small fraction of repopulated B cells consisted of a high percentage of transitional B cells .
RESULTS	Rituximab treatment had no effect on the T-cell phenotype and function post-transplant .
CONCLUSIONS	Renal transplant recipients treated with tacrolimus/MMF/steroids show an altered memory T and B-cell compartment post-transplant .
CONCLUSIONS	Additional B-cell depletion by rituximab leads to a relative increase of transitional and memory-like B cells , without affecting T-cell phenotype and function .
BACKGROUND	ClinicalTrials.gov NCT00565331 .

###25452069
BACKGROUND	Relapse rates following cognitive behavioral therapy ( CBT ) for alcohol dependence are high .
BACKGROUND	Continuing care programs can prolong therapeutic effects but are underutilized .
BACKGROUND	Thus , there is need to explore options having greater accessibility .
METHODS	This randomized controlled trial tested the efficacy of a novel , fully automated continuing care program , Alcohol Therapeutic Interactive Voice Response ( ATIVR ) .
METHODS	ATIVR enables daily monitoring of alcohol consumption and associated variables , offers targeted feedback , and facilitates use of coping skills .
METHODS	Upon completing 12weeks of group CBT for alcohol dependence , participants were randomly assigned to either four months of ATIVR ( n = 81 ) or usual care ( n = 77 ) .
METHODS	Drinking behavior was assessed pre - and post-CBT , then at 2weeks , 2months , 4months , and 12months post-randomization .
RESULTS	Drinking days per week increased over time for the control group but not the intervention group .
RESULTS	There were no significant differences between groups on the other alcohol-related outcome measures .
RESULTS	Comparisons on the subset of participants abstinent at the end of CBT ( n = 72 ) showed higher rates of continuous abstinence in the experimental group .
RESULTS	Effect sizes for the other outcome variables were moderate but not significant in this subgroup .
CONCLUSIONS	For continuing care , ATIVR shows some promise as a tool that may help clients maintain gains achieved during outpatient treatment .
CONCLUSIONS	However , ATIVR may not be adequate for clients who have not achieved treatment goals at the time of discharge .

###25214310
BACKGROUND	The Amberg-Schwandorf Algorithm for Primary Triage ( ASAV ) is a novel primary triage concept specifically for physician manned emergency medical services ( EMS ) systems .
BACKGROUND	In this study , we determined the diagnostic reliability and the time requirements of ASAV triage .
METHODS	Seven hundred eighty triage runs performed by 76 trained EMS providers of varying professional qualification were included into the study .
METHODS	Patients were simulated using human dummies with written vital signs sheets .
METHODS	Triage results were compared to a standard solution , which was developed in a modified Delphi procedure .
METHODS	Test performance parameters ( e.g. sensitivity , specificity , likelihood ratios ( LR ) , under-triage , and over-triage ) were calculated .
METHODS	Time measurements comprised the complete triage and tagging process and included the time span for walking to the subsequent patient .
METHODS	Results were compared to those published for mSTaRT .
METHODS	Additionally , a subgroup analysis was performed for employment status ( career/volunteer ) , team qualification , and previous triage training .
RESULTS	For red patients , ASAV sensitivity was 87 % , specificity 91 % , positive LR 9.7 , negative LR 0.139 , over-triage 6 % , and under-triage 10 % .
RESULTS	There were no significant differences related to mSTaRT .
RESULTS	Per patient , ASAV triage required a mean of 35.4 sec ( 75th percentile 46 sec , 90th percentile 58 sec ) .
RESULTS	Volunteers needed slightly more time to perform triage than EMS professionals .
RESULTS	Previous mSTaRT training of the provider reduced under-triage significantly .
RESULTS	There were significant differences in time requirements for triage depending on the expected triage category .
CONCLUSIONS	The ASAV is a specific concept for primary triage in physician governed EMS systems .
CONCLUSIONS	It may detect red patients reliably .
CONCLUSIONS	The test performance criteria are comparable to that of mSTaRT , whereas ASAV triage might be accomplished slightly faster .
CONCLUSIONS	From the data , there was no evidence for a clinically significant reliability difference between typical staffing of mobile intensive care units , patient transport ambulances , or disaster response volunteers .
CONCLUSIONS	Up to now , there is no clinical validation of either triage concept .
CONCLUSIONS	Therefore , reality based evaluation studies are needed .

###24335056
BACKGROUND	Circadian rhythm has been shown to be related to glucose metabolism and risk of diabetes , probably through effects on energy balance .
BACKGROUND	Recent genome-wide association studies identified variants in circadian rhythm-related genes ( CRY2 and MTNR1B ) associated with glucose homeostasis .
OBJECTIVE	We tested whether CRY2 and MTNR1B genotypes affected changes in measures of energy expenditure in response to a weight-loss diet intervention in a 2-y randomized clinical trial , the POUNDS ( Preventing Overweight Using Novel Dietary Strategies ) LOST Trial .
METHODS	The variants CRY2 rs11605924 ( n = 721 ) and MTNR1B rs10830963 ( n = 722 ) were genotyped in overweight or obese adults who were randomly assigned to 1 of 4 weight-loss diets that differed in their proportions of macronutrients .
METHODS	Respiratory quotient ( RQ ) and resting metabolic rate ( RMR ) were measured .
RESULTS	By 2 y of diet intervention , the A allele of CRY2 rs11605924 was significantly associated with a greater reduction in RQ ( P = 0.03 ) and a greater increase in RMR and RMR/kg ( both P = 0.04 ) .
RESULTS	The G allele of MTNR1B rs10830963 was significantly associated with a greater increase in RQ ( P = 0.01 ) but was not related to changes in RMR and RMR/kg .
RESULTS	In addition , we found significant gene-diet fat interactions for both CRY2 ( P-interaction = 0.02 ) and MTNR1B ( P-interaction < 0.001 ) in relation to 2-y changes in RQ .
CONCLUSIONS	Our data indicate that variants in the circadian-related genes CRY2 and MTNR1B may affect long-term changes in energy expenditure , and dietary fat intake may modify the genetic effects .
CONCLUSIONS	This trial was registered at www.clinicaltrials.gov as NCT00072995 .

###24271696
BACKGROUND	In the literature , chronic groin pain ( i.e. lasting > 3 months ) occurs in about 10 % of patients who undergo inguinal hernioplasty with prosthesis ; it is characterized by a broad range of symptoms , and is relative to individual perceptions of pain .
BACKGROUND	In 2-5 % of cases , the painful symptomatology is so intense that it interferes with daily activities , and can be debilitating in 0.5-6 % of cases .
BACKGROUND	The best known cause of inguinodynia is neuropathy , due to implication of one or more inguinal nerves ( iliohypogastric , ilioinguinal , and genitofemoral nerves ) into fibroblastic processes ; or from nervous stimulation caused by prosthetic material on adjacent nervous trunks .
BACKGROUND	Many therapeutic strategies have been proposed to treat chronic groin pain , including intra-operative prophylactic neurectomy .
OBJECTIVE	The purpose of our study was to perform a comparative analysis between outcomes from wide resections of inguinal nerves versus those from simple nervous section ( or minimal resection ) .
METHODS	We considered 350 patients who had undergone inguinal prosthetic hernioplasty with Trabucco 's technique between 2004 and 2010 .
METHODS	Wide nervous resection ( removal of nerve segments 3-8 cm in length ) was performed in 180 .
METHODS	The other 170 patients underwent simple section or minimal resection .
METHODS	All patients were checked 1 week , 1 month , and 1 year after surgery .
RESULTS	Group 1 : At 1-week follow-up , 63 patients ( 35 % ) reported no pain , 113 ( 63 % ) reported moderate pain , and 4 ( 2 % ) intense pain ; 1 month after the procedure , 152 patients ( 84.4 % ) reported no pain , 25 ( 14 % ) complained of moderate pain , and 3 ( 1.6 % ) of severe pain ; 1 year after surgery , only 1 patient ( 0.5 % ) complained of constant pain .
RESULTS	Group 2 : At 1 week follow-up , 48 patients ( 28 % ) reported no pain , 101 ( 59 % ) reported moderate pain , and 21 ( 13 % ) intense pain ; 1 month after the procedure , 81 patients ( 47.6 % ) had no pain , 72 ( 42.4 % ) complained of moderate pain , and 17 ( 10 % ) of severe pain ; 1 year after surgery , 11 patients ( 6.5 % ) had constant pain , and two of them were re-admitted for surgery .
RESULTS	The lower incidence of chronic pain after long nervous resection is statistically significant ( 0.5 vs. 6.5 % ; p = 0.006 ) ; the incidence of moderate pain 1 month after operation is also lower ( 14 vs. 42.4 % ; p < 0.0001 ) ; patients who underwent a long resection experienced faster resolution of pain symptomatology , during a month .
RESULTS	Also noteworthy is the lower incidence of intense pain in the short and medium term ( after 1 week , 13 vs. 2 % , p = 0.0005 ; after 1 month , 10 vs. 1.6 % , p = 0.0018 ) .
CONCLUSIONS	The prophylactic wide resection of selected segments of inguinal nerves , despite the apparent paradox of greater tissue damage , appears more effective than simple section at preventing postoperative inguinodynia , given both the lower incidence and the faster resolution of painful symptomatology .

###25528363
BACKGROUND	Cardiogenic shock ( CS ) is the leading cause of death in patients hospitalized with acute myocardial infarction ( AMI ) .
BACKGROUND	Biomarkers might help in risk stratification and understanding of pathophysiology .
BACKGROUND	Preliminary data suggests that patients with CS face a profound increase in the osteocyte-derived hormone fibroblast growth factor 23 ( FGF-23 ) , which acts as a negative regulator of serum phosphate levels .
BACKGROUND	The present study aimed to assess the predictive role of FGF-23 for clinical outcome in a large cohort of CS patients with and without renal dysfunction .
METHODS	In the randomized Intraaortic Balloon Pump in Cardiogenic Shock II ( IABP-SHOCK II ) trial , 600 patients with CS complicating AMI were assigned to therapy with or without IABP .
METHODS	Our predefined biomarker substudy included 182 patients .
METHODS	Blood sampling was performed in a standardized procedure at three different time points ( day 1 ( day of admission ) , day 2 and day 3 ) .
METHODS	Differences in outcome of patients with FGF-23 levels <and> median were compared by log-rank testing .
METHODS	Stepwise logistic regression modeling was performed to identify predictors of death at 30 days and Cox regression analysis for time to death during the first year .
RESULTS	At all three time points , nonsurvivors had significantly higher FGF-23 levels compared to survivors ( P < 0.001 for all ) .
RESULTS	Patients with FGF-23 levels above the median ( 395 RU/mL [ interquartile range 102 ; 2,395 ] ) were characterized by an increased 30-day mortality and 1-year mortality .
RESULTS	In multivariable analysis FGF-23 levels remained independent predictors for 30-day ( odds ratio per 10log 1.80 , 95 % confidence interval ( CI ) 1.11 to 2.92 ; P = 0.02 ) and 1-year mortality ( hazard ratio 1.50 , 95 % CI 1.11 to 2.04 , P = 0.009 ) .
RESULTS	After stratifying the patients according to their baseline serum creatinine levels , the negative prognostic association of increased FGF-23 was only significant in those with serum creatinine greater than median .
CONCLUSIONS	In CS , high levels of FGF-23 are independently related to a poor clinical outcome .
CONCLUSIONS	However , this prognostic association appears only to apply in patients with impaired renal function .
BACKGROUND	ClinicalTrials.gov NCT00491036 .
BACKGROUND	Registered 22 June 2007 .

###25198222
OBJECTIVE	To determine whether a weight-bearing physical activity intervention improves measures of bone density , size and strength in a pre - and early pubertal cohort of black South African children .
METHODS	Twenty two school children ( 9.71.1 years ) were cluster randomised into an exercise ( EX ; n = 12 ) and control ( CON ; n = 10 ) group .
METHODS	EX children performed a weight-bearing exercise program for 20 weeks .
METHODS	CON children continued their regular activities .
METHODS	Whole body DXA and tibial peripheral QCT scans were obtained .
METHODS	Urine was analysed for concentrations of cross-linked N-telopeptides of Type I collagen ( NTX ) .
RESULTS	Changes in 4 % volumetric BMD , area and strength were greater in EX than CON .
RESULTS	At the 38 % site , change in bone area and density was greater in EX than CON .
RESULTS	The greater change in periosteal circumference in the EX groups also resulted in a greater change in cortical thickness of the tibia compared to the CON group .
RESULTS	NTX concentration was lower in the EX group than the CON group after the intervention .
CONCLUSIONS	This study documents for the first time the beneficial response of trabecular and cortical bone of black children to a weight bearing exercise intervention .

###24930728
BACKGROUND	p38 MAPK inhibition has potential myocardial protective effects .
BACKGROUND	We assessed losmapimod , a potent oral p38 MAPK inhibitor , in patients with non-ST-segment elevation myocardial infarction ( NSTEMI ) in a double-blind , randomised , placebo-controlled trial .
METHODS	From October , 2009 , to November , 2011 , NSTEMI patients were assigned oral losmapimod ( 75 mg or 150 mg loading dose followed by 75 mg twice daily ) or matching placebo in a 3:3:2 ratio .
METHODS	Safety outcomes were serious adverse events and alanine aminotransferase ( ALT ) concentrations over 12 weeks , and cardiac events ( death , myocardial infarction , recurrent ischaemia , stroke , and heart failure ) at 90 days .
METHODS	Efficacy outcomes were high-sensitivity C-reactive protein ( hsCRP ) and B-type natriuretic peptide ( BNP ) concentrations at 72 h and 12 weeks , and troponin I area under the curve ( AUC ) over 72 h.
METHODS	The losmapimod groups were pooled for analysis .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00910962 .
RESULTS	Of 535 patients enrolled , 526 ( 98 % ) received at least one dose of study treatment ( losmapimod n = 388 and placebo n = 138 ) .
RESULTS	Safety outcomes did not differ between groups .
RESULTS	HsCRP concentrations at 72 h were lower in the losmapimod group than in the placebo group ( geometric mean 641 nmol/L , 95 % CI 530-776 vs 1108 nmol/L , 831-1477 ; p = 00009 ) but were similar at 12 weeks .
RESULTS	Early geometric mean BNP concentrations were similar at 72 h but significantly lower in the losmapimod group at 12 weeks ( 372 ng/L , 95 % CI 323-429 vs 494 ng/L , 387-630 ; p = 004 ) .
RESULTS	Mean troponin I AUC values did not differ .
CONCLUSIONS	p38 MAPK inhibition with oral losmapimod was well tolerated in NSTEMI patients and might improve outcomes after acute coronary syndromes .
BACKGROUND	GlaxoSmithKline .

###24835519
OBJECTIVE	Timely access to general practitioner ( GP ) care is a recognized strategy to address avoidable hospitalization .
OBJECTIVE	Little is known about patients seeking planned ( decided ahead ) and unplanned ( decided on day ) GP visits .
OBJECTIVE	The Patient Journey Record System ( PaJR ) provides a biopsychosocial real-time monitoring and support service to chronically ill and older people over 65 who may be at risk of an avoidable hospital admission .
OBJECTIVE	This study aims to describe reported profiles associated with planned and unplanned GP visits during the week in the PaJR database of regular outbound phone calls made by Care Guides to multi-morbid older patients .
METHODS	One hundred fifty consecutive patients with one or more chronic condition ( including chronic obstructive pulmonary disease , heart/vascular disease , heart failure and/or diabetes ) , one or more hospital admission in previous year , and consecutively recruited from hospital discharge , out-of-hour care and GP practices comprised the study sample .
METHODS	Using a semistructured script , Care Guides telephoned the patients approximately every 3 week days , and entered call data into the PaJR database in 2011 .
METHODS	The PaJR project identified and prompted unplanned visits according to its algorithms .
METHODS	Logistic regression modelling and descriptive statistics identified significant predictors of planned and unplanned visits and patterns of GP visits on weekdays reported in calls .
RESULTS	In 5096 telephone calls , unplanned versus planned GP visits were predicted by change in health state , significant symptom concerns , poor self-rated health , bodily pain and concerns about caregiver or intimates .
RESULTS	Calls not reporting visits had significantly fewer of these features .
RESULTS	Planned visits were associated with general and medication concerns , reduced social participation and feeling down .
RESULTS	Planned visits were highest on Monday and trended downwards to Fridays .
RESULTS	Unplanned visits were reported at the same rate each weekday and more frequently when the interval between calls was 3 days .
RESULTS	The PaJR project Care Guides advised patients to make unplanned visits in 6.3 % of calls and advised planned GP visits in 2.5 % of calls .
CONCLUSIONS	Unplanned GP visits consistently indicated a significant change to worse health with planned visits presenting less acuity in this study of older multi-morbid patients in general practice , when monitored by regular calls at about every 3 days .
CONCLUSIONS	The PaJR study actively prompted GP visits according to its algorithms .
CONCLUSIONS	Assessing and predicting acuity in older multi-morbid patients appears to be a promising strategy to improve access to primary care , and thus to reducing avoidable hospital utilization .
CONCLUSIONS	Further research is needed to investigate the topic on a wider scale .

###24835329
OBJECTIVE	This study sought to evaluate the relationship between post-stent strut apposition and follow-up strut coverage using contour plot optical coherence tomographic analysis .
BACKGROUND	Tracking the fate of interested regions of struts at different time points has not been investigated .
METHODS	Post-intervention and 6-month follow-up optical coherence tomographic evaluations were performed in 82 patients treated with biolimus - ( n = 37 ) or sirolimus-eluting stents ( n = 45 ) .
METHODS	Post-stent apposition was classified as embedded , apposed , or malapposed .
METHODS	For volumetric stent evaluation , the post-intervention strut-artery distance and the neointimal thickness at follow-up were measured as a function of the circumferential arc length and longitudinal stent length .
METHODS	Computer-generated contour plots of the strut-artery distance and neointimal thickness were compared .
RESULTS	The percentages of embedded and malapposed struts after intervention were 1.8 % ( Interquartile range [ IQR ] : 0.6 % to 6.2 % ) and 2.3 % ( IQR : 0.5 % to 5.2 % ) , respectively .
RESULTS	The percentages of uncovered and malapposed struts at 6 months were 16.0 % ( IQR : 7.4 % to 33.3 % ) and 0 % ( IQR : 0 % to 0.7 % ) , respectively .
RESULTS	The percentage of uncovered struts at 6 months varied significantly with post-stent strut apposition ( 0 % [ IQR : 0 % to 11.4 % ] in embedded , 16.3 % [ IQR : 8.1 % to 31.3 % ] in apposed , and 26.8 % [ IQR : 0 % to 56.3 % ] in malapposed , p < 0.001 for all pairwise comparisons ) .
RESULTS	In lesions without tissue prolapse , embedded struts were all covered ( 100 % covered struts ) compared with those with tissue prolapse ( 76.8 % covered , p < 0.001 ) .
CONCLUSIONS	The optical coherence tomography-guided optimization of stent strut apposition enhances strut coverage at follow-up .
CONCLUSIONS	This comprehensive method for evaluating strut apposition may provide more useful information to understanding the serial changes in strut coverage .
CONCLUSIONS	( Neointimal Coverage After Implantation of Biolimus Eluting Stent With Biodegradable Polymer : Optical Coherence Tomographic Assessment According to the Treatment of Dyslipidemia and Hypertension and the Types of Implanted Drug-Eluting Stents ; NCT01502904 ) .

###25831269
BACKGROUND	Despite investments in infrastructure and evidence for high acceptability , few mHealth interventions have been implemented in sub-Saharan Africa .
OBJECTIVE	We sought to ( 1 ) identify predictors of uptake of an mHealth application for a low-literacy population of people living with HIV ( PLWH ) in rural Uganda and ( 2 ) evaluate the efficacy of various short message service ( SMS ) text message formats to optimize the balance between confidentiality and accessibility .
METHODS	The trial evaluated the efficacy of a SMS text messaging app to notify PLWH of their laboratory results and request return to care for those with abnormal test results .
METHODS	Participants with a normal laboratory result received a single SMS text message indicating results were normal .
METHODS	Participants with an abnormal test result were randomized to 1 of 3 message formats designed to evaluate trade-offs between clarity and privacy : ( 1 ) an SMS text message that stated results were abnormal and requested return to clinic ( `` direct '' ) , ( 2 ) the same message protected by a 4-digit PIN code ( `` PIN '' ) , and ( 3 ) the message `` ABCDEFG '' explained at enrollment to indicate abnormal results ( `` coded '' ) .
METHODS	Outcomes of interest were ( 1 ) self-reported receipt of the SMS text message , ( 2 ) accurate identification of the message , and ( 3 ) return to care within 7 days ( for abnormal results ) or on the date of the scheduled appointment ( for normal results ) .
METHODS	We fit regression models for each outcome with the following explanatory variables : sociodemographic characteristics , CD4 count result , ability to read a complete sentence , ability to access a test message on enrollment , and format of SMS text message .
RESULTS	Seventy-two percent ( 234/385 ) of participants successfully receiving a message , 87.6 % ( 219/250 ) correctly identified the message format , and 60.8 % ( 234/385 ) returned to clinic at the requested time .
RESULTS	Among participants with abnormal tests results ( 138/385 , 35.8 % ) , the strongest predictors of reported message receipt were the ability to read a complete sentence and a demonstrated ability to access a test message on enrollment .
RESULTS	Participants with an abnormal result who could read a complete sentence were also more likely to accurately identify the message format ( AOR 4.54 , 95 % CI 1.42-14 .47 , P = .01 ) and return to clinic appropriately ( AOR 3.81 , 95 % CI 1.61-9 .03 , P = .002 ) .
RESULTS	Those who were sent a PIN-protected message were less likely to identify the message ( AOR 0.11 , 95 % CI 0.03-0 .44 , P = .002 ) or return within 7 days ( AOR 0.26 , 95 % CI 0.10-0 .66 , P = .005 ) .
RESULTS	Gender , age , and socioeconomic characteristics did not predict any outcomes and there were no differences in outcomes between those receiving direct or coded messages .
CONCLUSIONS	Confirmed literacy at the time of enrollment was a robust predictor of SMS text message receipt , identification , and appropriate response for PLWH in rural Uganda .
CONCLUSIONS	PIN-protected messages reduced odds of clinic return , but coded messages were as effective as direct messages and might augment privacy .
BACKGROUND	Clinicaltrials.gov NCT 01579214 ; https://clinicaltrials.gov/ct2/show/NCT01579214 ( Archived by WebCite at http://www.webcitation.org/6Ww8R4sKq ) .

###24235081
BACKGROUND	Velcalcetide , also known as AMG 416 , is a novel , long-acting selective peptide agonist of the calcium sensing receptor .
BACKGROUND	It is being developed as an intravenous treatment of secondary hyperparathyroidism ( SHPT ) in hemodialysis patients with chronic kidney disease-mineral and bone disorder .
OBJECTIVE	To assess the safety , tolerability , pharmacokinetics and pharmacodynamics of velcalcetide in healthy male volunteers .
METHODS	The study was a double-blind , randomized , placebo-controlled , single-dose , dose-escalation study in healthy males aged 18-45 years conducted at a single center .
METHODS	Each cohort included eight subjects randomized 6:2 to velcalcetide or placebo .
METHODS	Velcalcetide at 0.5 , 2 , 5 and 10 mg or placebo was administered intravenously .
RESULTS	Measurements included plasma ionized calcium ( iCa ) , serum total calcium , intact parathyroid hormone ( iPTH ) , phosphorus and fibroblast growth factor-23 ( FGF23 ) , 1,25-dihydroxyvitamin D , calcitonin and urine creatinine , calcium and phosphorus and plasma pharmacokinetics for velcalcetide .
RESULTS	Vital signs , safety biochemical and hematological indices , and adverse events were monitored throughout the study .
RESULTS	Intravenous administration of velcalcetide was well tolerated with no adverse reaction of nausea , vomiting or diarrhea reported .
RESULTS	Velcalcetide mediated dose-dependent decreases in serum iPTH at 30 min , FGF23 at 24 h and iCa at 12 h post dose ( P < 0.05 ) and in urine fractional excretion of phosphorus and increases in tubular reabsorption of phosphorus .
RESULTS	Velcalcetide plasma exposure increased in a dose-related manner and the terminal elimination of half-life was comparable across the dose range evaluated and ranged from 18.4 to 20.0 h.
CONCLUSIONS	Single IV doses of velcalcetide were well tolerated and associated with rapid , sustained , dose-dependent reductions in serum PTH .
CONCLUSIONS	The results support further evaluation of velcalcetide as a treatment for SHPT in hemodialysis patients .

###24603902
BACKGROUND	It is unclear whether endoscopic mediastinal lymph node ( LN ) staging techniques are equivalent to surgical mediastinal staging ( SMS ) techniques in patients with potentially operable non-small cell lung cancer ( NSCLC ) .
METHODS	A total of 166 patients with confirmed or suspected NSCLC who required SMS based on current guidelines were enrolled in this prospective controlled trial comparing endosonographic mediastinal LN staging with SMS .
METHODS	Each patient served as his or her own control .
METHODS	All patients underwent endobronchial ultrasound ( EBUS ) , endoscopic ultrasound ( EUS ) , and SMS during a single procedure .
METHODS	Results of EBUS , EUS , and combined EBUS/EUS were compared with SMS ( gold standard ) and in patients with negative LN staging results , with LN sampling at pulmonary resection .
RESULTS	EBUS , EUS , combined EBUS/EUS , and SMS sampled a mean of 2.2 , 1.7 , 3.9 , and 3.1 LN stations , respectively .
RESULTS	The prevalence of mediastinal nodal disease ( N2/N3 ) was 32 % ( 53 of 166 patients ) .
RESULTS	The sensitivity , negative predictive value , and diagnostic accuracy of the endoscopic staging modalities , respectively , were EBUS , 72 % ( 95 % CI , 0.58-0 .83 ) , 88 % ( 0.81-0 .93 ) , and 91 % ( 0.85-0 .95 ) ; EUS , 62 % ( 0.48-0 .75 ) , 85 % ( 0.78-0 .91 ) , and 88 % ( 0.82-0 .92 ) ; and combined EBUS/EUS , 91 % ( 0.79-0 .97 ) , 96 % ( 0.90-0 .99 ) , and 97 % ( 0.93-0 .99 ) .
RESULTS	Endosonography was diagnostic for N2/N3/M1 disease in 24 patients in whom SMS findings were negative , preventing futile thoracotomy in an additional 14 % of patients .
CONCLUSIONS	The combined EBUS/EUS procedure can replace surgical mediastinal staging in patients with potentially resectable NSCLC .
CONCLUSIONS	Additionally , endosonography leads to improved staging compared with SMS because it allows the biopsy of LNs and metastases unattainable with SMS techniques .
BACKGROUND	ClinicalTrials.gov ; No. : NCT01011595 ; URL : www.clinicaltrials.gov .

###24613632
BACKGROUND	To examine whether ( 1 ) the ` What Do You Drink ' ( WDYD ) intervention resulted in drinking refusal self-efficacy ( DRSE ) changes directly after the intervention , and if so , whether these changes sustained at six-months follow-up and ( 2 ) DRSE was related to alcohol use over time , and if so , whether the strength of these relationships differed across conditions .
BACKGROUND	Insight herein can help explain the sustained preventive effects of the WDYD intervention on alcohol use , as reported previously .
METHODS	Alcohol use and DRSE data were collected from 907 participants ( 60.3 % male ; M = 20.8 ( SD = 1.7 ) in a two-arm parallel group randomized controlled trial applying ecological momentary assessment with 30 time-points .
METHODS	Participants were randomized to the experimental ( n = 456 : WDYD intervention ) or control condition ( n = 451 : no intervention ) .
RESULTS	Latent Growth Curve ( LGC ) analyses that modeled individual change in DRSE over time by condition revealed that participants in the experimental condition experienced a higher social pressure DRSE compared to participants in the control condition at six-months follow-up .
RESULTS	Moreover , LGC analyses with time-varying covariates revealed that DRSE was negatively related to weekly alcohol consumption and social pressure DRSE to frequency of binge drinking .
RESULTS	The WDYD intervention did not affect the strength of these relationships .
CONCLUSIONS	The WDYD intervention increased the level of social pressure DRSE directly after the intervention that sustained at six-months follow-up .
CONCLUSIONS	This change is likely to be responsible for the sustained preventive effects of the WDYD intervention on alcohol use , as reported previously .

###25827597
OBJECTIVE	The objective is to compare the analgesic effects of diclofenac , acetaminophen , and acupuncture in urolithiasis-driven renal colic pain relief .
METHODS	Renal colic patients were divided randomly into 3 groups .
METHODS	Patients in group I ( n = 40 ) were treated with intravenous acetaminophen , those in group II ( n = 41 ) with acupuncture , and those in group III ( n = 40 ) with a 75-mg intramuscular injection diclofenac sodium .
METHODS	Visual analogue scale ( VAS ) and verbal rating scale ( VRS ) were used to assess pain intensity after 10 , 30 , 60 , and 120 minutes .
RESULTS	No significant differences in baseline VAS or VRS were found with regard to age or sex .
RESULTS	After 10 minutes , all 3 groups experienced a significant decrease in VAS and VRS scores , with the most drastic decrease occurring in group II .
RESULTS	After 30 minutes , there was a significantly higher decrease in group III than in group I ( P = .001 ) .
RESULTS	After 60 minutes , mean VAS scores of groups I and III ( P = .753 ) were similar .
RESULTS	The mean VAS score of group III was lower than that of group II ( P = .013 ) .
RESULTS	After 120 minutes , the difference in the VAS scores was ( P = .000 ) between groups I and II and between groups II and III .
RESULTS	Yet , the VAS evaluation made after 120 minutes revealed statistically similar outcomes for groups I and III ( P = .488 ) .
RESULTS	The statistical findings for VRS evaluations made after 10 , 30 , 60 , and 120 were similar to those for VAS .
CONCLUSIONS	In renal colic patients with a possible nonsteroidal anti-inflammatory drug and acetaminophen side effect risk , acupuncture emerges as an alternative treatment modality .

###24759202
OBJECTIVE	The aim of this study was to compare a highly structured planned rest protocol that includes visitor and healthcare personnel restrictions with a simple planned rest period that encourages patients to rest during a designated time without restriction of visitors and healthcare personnel .
BACKGROUND	Many hospitals acute care have begun to restrict visitors and nonessential health team interventions during specific times despite the lack of experimentally designed studies .
METHODS	Using a convenience sample of 52 intermediate care unit patients , a randomized experimental design study compared a highly structured planned rest protocol with restriction of visitors/healthcare personnel to a simple planned rest period without restrictions .
METHODS	The primary outcome variable was the patient 's perceived quality of rest after a 2-hour rest period .
RESULTS	Intermediate care patients ' perception of rest and sleep during a designated rest period was similar whether elaborate rest strategies were used , including visitor and healthcare personnel restrictions , or if it was only suggested they rest and the door to their room closed .
CONCLUSIONS	The restriction of visitors and healthcare personnel during a 2-hour rest period did not improve the patient 's perception of rest or how long it took them to go to sleep .

###24673076
OBJECTIVE	To observe the efficacy of encephalopathy therapeutic tongue acupoint apparatus ( ETTAA ) in the treatment of autism .
METHODS	Eighty-four children of autism were randomly divided into a tongue acupuncture group ( group A ) and a conventional training group ( group B ) , 42 cases in each group .
METHODS	The behavior training and sensory integration training were carried out in group B and the ETTAA was added in group A.
METHODS	The apparatus was switched on for 20 min every time and 3 times a day .
METHODS	Treatment of two months were carried out in both groups .
METHODS	The score of childhood autism rating scale ( CARS ) and clinical efficacy in both groups were observed before and after treatment .
RESULTS	After treatment , the CARS in both groups were significantly reduced ( 42.39 + / - 6.86 vs 32.15 + / - 5.12 , P < 0.001 ; 44.58 + / - 6.76 vs 39.72 + / - 7.11 , P < 0.05 ) , which was more significant in group A ( P < 0.01 ) .
RESULTS	The totally effective rate in group A [ 90.5 % ( 38/42 ) ] was superior to that in group B [ 66.7 % ( 28/42 ) , P < 0.01 ] .
CONCLUSIONS	The clinical efficacy in tongue acupuncture group is apparently superior to that in conventional training group , ETTAA combined with conventional training have a better curative effect in the treatment of autism .

###24636035
OBJECTIVE	To evaluate the effect of tobacco cessation brief-intervention ( BI ) training for lay `` health influencers , '' on knowledge , self-efficacy and the proportion of participants reporting BI delivery post-training .
METHODS	Randomized , community-based study comparing In-person or Web-based training , with mailed materials .
RESULTS	In-person and Web-training groups had significant post-training cessation knowledge and self-efficacy gains .
RESULTS	All groups increased the proportion of individuals reporting BIs at follow-up , with no significant between-group differences .
RESULTS	Irrespective of participants ' prior intervention experience , 80 % -86 % reported BIs within the past 90 days ; 71 % -79 % reported > 1 in the past 30 .
CONCLUSIONS	Web and In-person training significantly increase health influencer cessation knowledge and self-efficacy .
CONCLUSIONS	With minimal prompting and materials , even persons without BI experience can be activated to encourage tobacco cessation .

###25174863
BACKGROUND	Chronic sinonasal disease is common in asthmatic patients and associated with poor asthma control ; however , there are no long-term trials addressing whether chronic treatment of sinonasal disease improves asthma control .
OBJECTIVE	We sought to determine whether treatment of chronic sinonasal disease with nasal corticosteroids improves asthma control , as measured by the Childhood Asthma Control Test and Asthma Control Test in children and adults , respectively .
METHODS	A 24-week multicenter , randomized , placebo-controlled , double-blind trial of placebo versus nasal mometasone in adults and children with inadequately controlled asthma was performed .
METHODS	Treatments were randomly assigned , with concealment of allocation .
RESULTS	Two hundred thirty-seven adults and 151 children were randomized to nasal mometasone versus placebo , and 319 participants completed the study .
RESULTS	There was no difference in the Childhood Asthma Control Test score ( difference in change with mometasone - change with placebo [ M - P ] , -0.38 ; 95 % CI , -2.19 to 1.44 ; P = .68 ; age 6-11 years ) or the Asthma Control Test score ( M - P , 0.51 ; 95 % CI , -0.46 to 1.48 ; P = .30 ; age 12 years ) in those assigned to mometasone versus placebo .
RESULTS	In children and adolescents ( age 6-17 years ) there was no difference in asthma or sinus symptoms but a decrease in episodes of poorly controlled asthma defined by a decrease in peak flow .
RESULTS	In adults there was a small difference in asthma symptoms measured by using the Asthma Symptom Utility Index ( M - P , 0.06 ; 95 % CI , 0.01 to 0.11 ; P < .01 ) and in nasal symptoms ( sinus symptom score M - P , -3.82 ; 95 % CI , -7.19 to -0.45 ; P = .03 ) but no difference in asthma quality of life , lung function , or episodes of poorly controlled asthma in adults assigned to mometasone versus placebo .
CONCLUSIONS	Treatment of chronic sinonasal disease with nasal corticosteroids for 24 weeks does not improve asthma control .
CONCLUSIONS	Treatment of sinonasal disease in asthmatic patients should be determined by the need to treat sinonasal disease rather than to improve asthma control .

###25605843
OBJECTIVE	The phase III CRYSTAL study demonstrated that addition of cetuximab to fluorouracil , leucovorin , and irinotecan ( FOLFIRI ) significantly improved overall survival , progression-free survival , and objective response in the first-line treatment of patients with KRAS codon 12/13 ( exon 2 ) wild-type metastatic colorectal cancer ( mCRC ) .
OBJECTIVE	Outcome was reassessed in subgroups defined by extended RAS mutation testing .
METHODS	Existing DNA samples from KRAS exon 2 wild-type tumors from CRYSTAL study patients were reanalyzed for other RAS mutations in four additional KRAS codons ( exons 3 and 4 ) and six NRAS codons ( exons 2 , 3 , and 4 ) using beads , emulsion , amplification , and magnetics technology .
METHODS	No tissue microdissection was performed .
METHODS	A 5 % mutant allele cutoff was used to call mutations .
RESULTS	Mutation status was evaluable in 430 ( 64.6 % ) of 666 patients with KRAS exon 2 wild-type tumors .
RESULTS	Other RAS mutations were detected in 63 ( 14.7 % ) of 430 patients .
RESULTS	In those with RAS wild-type tumors , a significant benefit across all efficacy end points was associated with the addition of cetuximab to FOLFIRI .
RESULTS	In patients with other RAS tumor mutations , no difference in efficacy outcomes between treatment groups was seen .
RESULTS	The safety profile in RAS subgroups was similar and in line with expectations .
CONCLUSIONS	In the first-line treatment of mCRC , patients with RAS wild-type tumors derived a significant benefit from the addition of cetuximab to FOLFIRI ; patients with RAS tumor mutations did not .
CONCLUSIONS	Molecular testing of tumors for all activating RAS mutations is essential before considering anti-epidermal growth factor receptor therapy , thereby allowing the further tailoring of cetuximab administration to maximize patient benefit .

###25127084
OBJECTIVE	Chronic stimulation and dysregulation of the neuroendocrine system by stress may cause metabolic abnormalities .
OBJECTIVE	We estimated how much cortisol and psychosocial outcomes improved with a restorative yoga ( relaxation ) versus a low impact stretching intervention for individuals with the metabolic syndrome .
METHODS	We conducted a 1-year multi-center randomized controlled trial ( 6-month intervention and 6-month maintenance phase ) of restorative yoga vs. stretching .
METHODS	Participants completed surveys to assess depression , social support , positive affect , and stress at baseline , 6 months and 12 months .
METHODS	For each assessment , we collected saliva at four points daily for three days and collected response to dexamethasone on the fourth day for analysis of diurnal cortisol dynamics .
METHODS	We analyzed our data using multivariate regression models , controlling for study site , medications ( antidepressants , hormone therapy ) , body mass index , and baseline cortisol values .
RESULTS	Psychosocial outcome measures were available for 171 study participants at baseline , 140 at 6 months , and 132 at 1 year .
RESULTS	Complete cortisol data were available for 136 of 171 study participants ( 72 in restorative yoga and 64 in stretching ) and were only available at baseline and 6 months .
RESULTS	At 6 months , the stretching group had decreased cortisol at waking and bedtime compared to the restorative yoga group .
RESULTS	The pattern of changes in stress mirrored this improvement , with the stretching group showing reductions in chronic stress severity and perseverative thoughts about their stress .
RESULTS	Perceived stress decreased by 1.5 points ( -0.4 ; 3.3 , p = 0.11 ) at 6 months , and by 2.0 points ( 0.1 ; 3.9 , p = 0.04 ) at 1 year in the stretching compared to restorative yoga groups .
RESULTS	Post hoc analyses suggest that in the stretching group only , perceived increases in social support ( particularly feelings of belonging ) , but not changes in stress were related to improved cortisol dynamics .
CONCLUSIONS	We found significant decreases in salivary cortisol , chronic stress severity , and stress perception in the stretching group compared to the restorative yoga group .
CONCLUSIONS	Group support during the interactive stretch classes may have contributed to these changes .

###25050491
BACKGROUND	Part of the myocardial damage occurring during cardiac surgery is a consequence of reperfusion injury .
BACKGROUND	Cyclosporine , a potent inhibitor of the opening of the mitochondrial permeability transition pore , attenuates reperfusion injury in patients with acute ST-segment elevation myocardial infarction .
BACKGROUND	This study investigated whether the administration of cyclosporine just before the aortic cross-unclamping would reduce myocardial injury in patients undergoing aortic valve surgery .
METHODS	This study was a monocentric , prospective , randomized , single-blinded , controlled trial .
METHODS	Sixty-one patients , scheduled for elective aortic valve surgery , were randomly assigned ( computer-generated randomization sequence ) to receive either an intravenous bolus of cyclosporine ( 2.5 mg/kg , cyclosporine group , n = 30 ) or normal saline ( control group , n = 31 ) 10 min before aortic cross-unclamping .
METHODS	The primary endpoint was the 72-h area under the curve for cardiac troponin I.
RESULTS	Both groups were similar with respect to baseline characteristics and aortic cross-clamping duration .
RESULTS	A significant 35 % reduction of area under the curve for cardiac troponin I was observed in the cyclosporine group compared with the control group ( 242 225 vs. 155 71 arbitrary units , mean SD ; mean difference , -86.2 42.5 ; 95 % CI , -172.3 to -0.1 ; P = 0.03 ) .
RESULTS	Cyclosporine beneficial effect remained significant after adjustment for aortic cross-clamping duration in each group ( mean difference , -88 34 , 95 % CI , -157 to -19 ; P = 0.01 ) .
RESULTS	None of the treated patients had significant side effects ( odds ratio , 0.64 ; 95 % CI , 0.16 to 2.55 ; P = 0.52 ) .
CONCLUSIONS	Cyclosporine administration at the time of reperfusion protects against reperfusion injury in patients undergoing aortic valve surgery .
CONCLUSIONS	The clinical benefit of this protection requires confirmation in a larger clinical trial .

###25666325
BACKGROUND	Recent work has shown no difference in change of LVEF between RV apical ( RVA ) pacing and non-RVA pacing in patients with normal LV function .
BACKGROUND	We hypothesised that a more sensitive marker ( global longitudinal strain , GLS ) could identify a detrimental effect of RVA and that assessment of deformation could identify whether dyssynchrony , contraction inefficiency and regional LV impairment were responsible for functional changes .
METHODS	In this substudy of Protect-PACE ( The Protection of Left Ventricular Function During Right Ventricular Pacing .
METHODS	Does Right Ventricular High-septal Pacing Improve Outcome Compared With Right Ventricular Apical Pacing ? )
METHODS	, a randomised controlled trial of RVA and non-RVA pacing in pacemaker-dependent patients with preserved EF , 145 patients ( 76 with RVA ) with echocardiograms of sufficient quality underwent measurement of LV longitudinal strain ( GLS ) from speckle tracking just after implantation and at 2 years .
METHODS	LV dyssynchrony , discoordination and regional apical longitudinal strain were also measured .
RESULTS	Pacing was associated with reduced GLS after 2 years , although 2-year GLS was lower in RVA ( -13.9 4.1 vs -15.5 4.6 , p = 0.02 ) .
RESULTS	RVA was an independent correlate of GLS , although there was a minor difference in GLS between the RVA and non-RVA groups ( -1.8 3.6 vs -0.8 3.4 % , p = 0.07 ) , reflecting impairment of GLS at baseline in RVA .
RESULTS	Apical strain was significantly lower in RVA than those in non-RVA at baseline and 2 years ( both p < 0.01 ) .
RESULTS	Dyssynchrony and discoordination parameters at 2 years also showed significant deterioration in RVA .
RESULTS	Apical strain , dyssynchrony and discoordination parameters at 2 years were significantly associated with GLS .
CONCLUSIONS	Inefficient dyssynchronous contraction and the decrease in apical strain appear to be associated with global LV impairment in RVA .
BACKGROUND	PROTECT-PACE ClinicalTrials.gov number NCT00461734 .

###24755192
BACKGROUND	Left ventricular hypertrophy ( LVH ) is common in kidney transplant ( KT ) recipients .
BACKGROUND	LVH is associated with a worse outcome , though m-TOR therapy may help to revert this complication .
BACKGROUND	We therefore conducted a longitudinal study to assess morphological and functional echocardiographic changes after conversion from CNI to m-TOR inhibitor drugs in nondiabetic KT patients who had previously received RAS blockers during the follow-up .
METHODS	We undertook a 1-year nonrandomized controlled study in 30 non-diabetic KT patients who were converted from calcineurin inhibitor ( CNI ) to m-TOR therapy .
METHODS	A control group received immunosuppressive therapy based on CNIs .
METHODS	Two echocardiograms were done during the follow-up .
RESULTS	Nineteen patients were switched to SRL and 11 to EVL .
RESULTS	The m-TOR group showed a significant reduction in LVMi after 1 year ( from 62 22 to 55 20 g/m2 .7 ; P = 0.003 , paired t-test ) .
RESULTS	A higher proportion of patients showing LVMi reduction was observed in the m-TOR group ( 53.3 versus 29.3 % , P = 0.048 ) at the study end .
RESULTS	In addition , only 56 % of the m-TOR patients had LVH at the study end compared to 77 % of the control group ( P = 0.047 ) .
RESULTS	A significant change from baseline in deceleration time in early diastole was observed in the m-TOR group compared with the control group ( P = 0.019 ) .
CONCLUSIONS	Switching from CNI to m-TOR therapy in non-diabetic KT patients may regress LVH , independently of blood pressure changes and follow-up time .
CONCLUSIONS	This suggests a direct non-hemodynamic effect of m-TOR drugs on cardiac mass .

###24756462
OBJECTIVE	This bioequivalence study aimed to compare rate and extent of absorption of a generic medicinal product of ibandronic acid 150-mg film-coated tablet versus Bonviva ( ) .
METHODS	This was a single-centre , open-label , randomized , three-way , three-sequence , reference-replicated , crossover bioequivalence study , under fasting conditions .
METHODS	A single oral dose of ibandronic acid as one 150-mg film-coated tablet was administered in each study period .
METHODS	Each washout period lasted 14 days .
METHODS	Blood samples were collected according to a predefined sampling schedule and up to 48.0 hours after administraton in each period .
METHODS	Plasma concentrations of ibandronic acid were measured using a liquid chromatograph-mass spectrometry/mass spectrometry method .
METHODS	Bioequivalence between generic and reference medicinal products is acceptable if the 90 % confidence intervals ( CI ) of ratio of least-squares means between the test and the reference product of ln-transformed area under the serum concentration-time curve from time zero to time of last measurable concentration ( AUC0-t ) is within the 80.00-125 .00 % interval .
METHODS	Prospectively , a scaled average bioequivalence approach for maximum serum concentration ( C max ) was established .
RESULTS	153 healthy volunteers were enrolled and randomized .
RESULTS	After the test formulation ( T ) and first and second Bonviva ( ) ( R ) dosing , the C max was 96.71 90.19 ng/mL , 92.67 91.48 ng/mL and 87.94 60.20 ng/mL and the AUC0-t was 390.83 287.27 ngh/mL , 388.54 356.76 ngh/mL and 383.53 246.72 , respectively .
RESULTS	Ratios of T/R and 90 % CI were 100.92 % ( 94.35-107 .94 ) for AUC0-t , 100.90 % ( 94.37-107 .88 ) for AUC0-inf and 102.56 % ( 95.05-110 .67 ) for C max .
CONCLUSIONS	Test formulation of ibandronic acid is bioequivalent in rate and extent of absorption to Bonviva ( ) following a 150-mg dose , under fasting conditions .

###25525349
OBJECTIVE	Cognitive stimulation therapy ( CST ) is a widely used , evidence-based intervention for people with dementia ( PwD ) .
OBJECTIVE	Although designed as a 14 session , twice weekly intervention , many services in the UK deliver CST once a week for 14 weeks .
OBJECTIVE	However , this method of delivery has yet to be evaluated .
OBJECTIVE	In addition , CST does not include any formal carer training .
OBJECTIVE	This study aimed to evaluate the effectiveness of once weekly CST and determine any additional impact when enhanced with a carer training program .
METHODS	A single blind , randomized controlled trial was conducted .
METHODS	Sixty eight PwD and their carers were recruited through three community Memory Assessment Services .
METHODS	PwD and their carers were randomized to one of three conditions : CST plus carer training , CST only , or a wait list control .
METHODS	PwD were administered standardized measures of cognition , quality of life , and quality of relationship with carer at baseline and the 15 week follow-up .
RESULTS	There were no baseline differences across the three groups .
RESULTS	At follow-up , there were no significant differences between PwD in the three groups on any outcomes .
CONCLUSIONS	Weekly CST with or without carer training may not be an effective form of delivery .
CONCLUSIONS	Several possible explanations for the outcomes are proposed .
CONCLUSIONS	Weekly CST may not offer the necessary `` dose '' required to combat decline , and equally the carer training may have been too brief to have made a difference .
CONCLUSIONS	Services currently offering weekly CST should collect routine outcome data to support its use and provide practice-based evidence .

###25629793
BACKGROUND	Intranasal steroids are recognized as an effective treatment for allergic rhinitis ( AR ) although their effect on nasal patency has never been evaluated with an objective instrument such as anterior rhinomanometry in children .
BACKGROUND	Moreover this effect has been widely assessed with total Nasal Symptom Scores ( NSS ) including all symptoms of allergic rhinitis and not with scores specifically focused on nasal obstruction such as the Nasal Obstruction Symptom Evaluation score ( NOSE ) .
METHODS	Sixty children ( 42 males and 18 female ) aged 6-10 years , affected by persistent AR , were randomized and divided in two groups of 30 children to be included in an unblinded trial : one group treated with intranasal budesonide and isotonic nasal saline for 2 weeks and the other group treated only with isotonic nasal saline for 2 weeks .
METHODS	Each child underwent rhinomanometry and completed the NSS and the NOSE scores before and after treatment .
RESULTS	At the baseline nasal patency and NSS total score , NOSE total scores were correlated ( r = -0.29 , p < 0.001 ; r = -60 , p < 0.001 ) .
RESULTS	After 2 weeks of treatment improvements in nasal patency , NSS and NOSE were seen ( NSS 4.13 1.38 vs 1.33 1.93 , p < 0.001 ; NOSE 34 17.97 vs 9 18.21 , p < 0.001 ; nasal patency -26.13 25.25 vs -11.83 11.31 , p < 0.001 ) .
RESULTS	Correlations were found between rhinitis duration and nasal patency and NOSE ( r = -0.84 , p < 0.001 ; r = 0.43 , p < 0.01 ) .
CONCLUSIONS	Intranasal budesonide is effective in increasing nasal patency in children .
CONCLUSIONS	Moreover the NOSE score was strongly correlated with nasal flow and , hence , this score should be regarded as a valid and reliable instrument in children .

###24235903
OBJECTIVE	Sleep hygiene recommendations are widely disseminated despite the fact that few systematic studies have investigated the empirical bases of sleep hygiene in the home environment .
OBJECTIVE	For example , studies have yet to investigate the relative effects of a given dose of caffeine administered at different times of day on subsequent sleep .
METHODS	This study compared the potential sleep disruptive effects of a fixed dose of caffeine ( 400 mg ) administered at 0 , 3 , and 6 hours prior to habitual bedtime relative to a placebo on self-reported sleep in the home .
METHODS	Sleep disturbance was also monitored objectively using a validated portable sleep monitor .
RESULTS	Results demonstrated a moderate dose of caffeine at bedtime , 3 hours prior to bedtime , or 6 hours prior to bedtime each have significant effects on sleep disturbance relative to placebo ( p < 0.05 for all ) .
CONCLUSIONS	The magnitude of reduction in total sleep time suggests that caffeine taken 6 hours before bedtime has important disruptive effects on sleep and provides empirical support for sleep hygiene recommendations to refrain from substantial caffeine use for a minimum of 6 hours prior to bedtime .

###25165165
BACKGROUND	Defining mucosal immune responses and inflammation to candidate human immunodeficiency virus type 1 ( HIV-1 ) vaccines represents a current research priority for the HIV-1 vaccine field .
BACKGROUND	In particular , it is unclear whether intramuscular immunization can elicit immune responses at mucosal surfaces in humans .
METHODS	In this double-blind , randomized , placebo-controlled clinical trial , we evaluated systemic and mucosal immune responses to a candidate adenovirus serotype 26 ( Ad26 ) vectored HIV-1 envelop ( Env ) vaccine in baseline Ad26-seronegative and Ad26-seropositive healthy volunteers .
METHODS	Systematic mucosal sampling with rectal Weck-Cel sponges and rectal biopsies were performed .
RESULTS	Intramuscular immunization elicited both systemic and mucosal Env-specific humoral and cellular immune responses in the majority of subjects .
RESULTS	Individuals with preexisting Ad26-specific neutralizing antibodies had vaccine-elicited immune responses comparable to those of subjects who were Ad26 seronegative .
RESULTS	We also observed no increase in activated total or vector-specific mucosal CD4 + T lymphocytes following vaccination by either histopathology or flow cytometry .
CONCLUSIONS	These data demonstrate that a single intramuscular administration of this Ad26-vectored HIV-1 Env vaccine elicited both systemic and mucosal immune responses in humans .
CONCLUSIONS	Induction of antigen-specific humoral and cellular mucosal immunity was not accompanied by a detectable increase in mucosal inflammation .
BACKGROUND	NCT01103687 .

###25613115
BACKGROUND	C-reactive protein ( CRP ) is a marker of systemic inflammation that has been associated with the incidence and prognosis for a number of different cancers .
BACKGROUND	Recent data suggest that CRP may be a prognostic factor for liver cancer and cirrhosis .
BACKGROUND	However , few long-term studies are available .
METHODS	We prospectively examined associations between serum CRP and subsequent risk of liver cancer incidence or chronic liver disease mortality in a nested case-control study performed in the Linxian Nutrition Intervention Trials cohort .
METHODS	Baseline serum CRP was measured for 220 incident liver cancer cases , 276 participants who died of chronic liver disease , and 1,018 age - , sex - , and trial-matched controls .
METHODS	Unconditional logistical regression models were used to estimate ORs and 95 % confidence intervals ( CI ) .
RESULTS	Compared with the lowest quartile , subjects in the fourth quartile of serum CRP had a higher risk of liver cancer incidence ( OR , 1.63 ; 95 % CI , 1.06-2 .51 ) , with a significant Ptrend across quartiles ( P = 0.01 ) .
RESULTS	The association with liver cancer was only significant among men ( Q4 vs. Q1 ; OR , 2.00 ; 1.10-3 .62 ) , but not among women ( Q4 vs. Q1 ; OR , 1.15 ; 0.60-2 .22 ) .
RESULTS	For chronic liver disease deaths , the corresponding risk estimate in men and women was 2.95 ( 1.90-4 .57 ) , with a monotonic trend ( P < 0.001 ) .
CONCLUSIONS	Higher serum CRP concentrations at baseline were associated with subsequent incidence of liver cancer and death from chronic liver disease .
CONCLUSIONS	Our findings suggest that levels of systemic inflammation may serve as a long-term marker of liver cancer and liver disease .

###24631057
BACKGROUND	Spinal anaesthesia for caesarean delivery is frequently associated with adverse effects such as maternal hypotension and bradycardia .
BACKGROUND	Prophylactic administration of ondansetron has been reported to provide a protective effect .
BACKGROUND	We studied the effect of different doses of ondansetron in obstetric patients .
METHODS	This prospective double-blind , randomised , placebo-controlled study included 128 healthy pregnant women scheduled for elective caesarean delivery under spinal anaesthesia .
METHODS	Women were randomly allocated into four groups ( n = 32 ) to receive either placebo or ondansetron 2 , 4 or 8 mg intravenously before induction of spinal anaesthesia .
METHODS	Demographic , obstetric , intraoperative timing and anaesthetic variables were assessed at 16 time points .
METHODS	Anaesthetic variables assessed included blood pressure , heart rate , oxygen saturation , nausea , vomiting , electrocardiographic changes , skin flushing , discomfort or pruritus and vasopressor requirements .
RESULTS	There were no differences in the number of patients with hypotension in the placebo ( 43.8 % ) and ondansetron 2mg ( 53.1 % ) , 4 mg ( 56.3 % ) and 8 mg ( 53.1 % ) groups ( P = 0.77 ) , nor the percentage of time points with systolic hypotension ( 7.3 % in the placebo group and 11.1 % , 15.7 % and 12.6 % in the ondansetron 2 , 4 and 8 mg groups , respectively , P = 0.32 ) .
RESULTS	There were no differences between groups in ephedrine ( P = 0.11 ) or phenylephrine ( P = 0.89 ) requirements and the number of patients with adverse effects .
CONCLUSIONS	In our study , prophylactic ondansetron had little effect on the incidence of hypotension in healthy parturients undergoing spinal anaesthesia with bupivacaine and fentanyl for elective caesarean delivery .

###24798395
OBJECTIVE	To determine the stability of beliefs of patients with Type 2 diabetes about their diabetes over 3 years , following diagnosis .
METHODS	Data were collected as part of a multicentre cluster randomized controlled trial of a 6-h self-management programme , across 207 general practices in the UK .
METHODS	Participants in the original trial were eligible for follow-up with biomedical data ( HbA1c levels , blood pressure , weight , blood lipid levels ) collected at the practice , and questionnaire data collected by postal distribution and return .
METHODS	Psychological outcome measures were depression ( Hospital Anxiety and Depression Scale ) and diabetes distress ( Problem Areas in Diabetes scale ) .
METHODS	Illness beliefs were assessed using the Illness Perceptions Questionnaire-Revised and the Diabetes Illness Representations Questionnaire scales .
RESULTS	At 3-year follow-up , all post-intervention differences in illness beliefs between the intervention and the control group remained significant , with perceptions of the duration of diabetes , seriousness of diabetes and perceived impact of diabetes unchanged over the course of the 3-year follow-up .
RESULTS	The control group reported a greater understanding of diabetes during the follow-up , and the intervention group reported decreased responsibility for diabetes outcomes during the follow-up .
RESULTS	After controlling for 4-month levels of distress and depression , the perceived impact of diabetes at 4 months remained a significant predictor of distress and depression at 3-year follow-up .
CONCLUSIONS	Peoples ' beliefs about diabetes are formed quickly after diagnosis , and thereafter seem to be relatively stable over extended follow-up .
CONCLUSIONS	These early illness beliefs are predictive of later psychological distress , and emphasize the importance of initial context and provision of diabetes care in shaping participants ' future well-being .

###25802354
OBJECTIVE	Atopic dermatitis ( AD ) primarily affects infants and young children .
OBJECTIVE	Although topical corticosteroids ( TCSs ) are often prescribed , noncorticosteroid treatments are needed because compliance with TCSs is poor due to concerns about their side effects .
OBJECTIVE	In this longest and largest intervention study ever conducted in infants with mild-to-moderate AD , pimecrolimus 1 % cream ( PIM ) was compared with TCSs .
METHODS	A total of 2418 infants were enrolled in this 5-year open-label study .
METHODS	Infants were randomized to PIM ( n = 1205 ; with short-term TCSs for disease flares ) or TCSs ( n = 1213 ) .
METHODS	The primary objective was to compare safety ; the secondary objective was to document PIM 's long-term efficacy .
METHODS	Treatment success was defined as an Investigator 's Global Assessment score of 0 ( clear ) or 1 ( almost clear ) .
RESULTS	Both PIM and TCSs had a rapid onset of action with > 50 % of patients achieving treatment success by week 3 .
RESULTS	After 5 years , > 85 % and 95 % of patients in each group achieved overall and facial treatment success , respectively .
RESULTS	The PIM group required substantially fewer steroid days than the TCS group ( 7 vs 178 ) .
RESULTS	The profile and frequency of adverse events was similar in the 2 groups ; in both groups , there was no evidence for impairment of humoral or cellular immunity .
CONCLUSIONS	Long-term management of mild-to-moderate AD in infants with PIM or TCSs was safe without any effect on the immune system .
CONCLUSIONS	PIM was steroid-sparing .
CONCLUSIONS	The data suggest PIM had similar efficacy to TCS and support the use of PIM as a first-line treatment of mild-to-moderate AD in infants and children .

###25406953
BACKGROUND	To date , no therapeutic option has been established for sudden deafness refractory to systemic corticosteroids .
BACKGROUND	This study aimed to examine the efficacy and safety of topical insulin-like growth factor-1 ( IGF-1 ) therapy in comparison to intratympanic corticosteroid therapy .
METHODS	We randomly assigned patients with sudden deafness refractory to systemic corticosteroids to receive either gelatin hydrogels impregnated with IGF-1 in the middle ear ( 62 patients ) or four intratympanic injections with dexamethasone ( Dex ; 58 patients ) .
METHODS	The primary outcome was the proportion of patients showing hearing improvement ( 10 decibels or greater in pure-tone average hearing thresholds ) 8 weeks after treatment .
METHODS	The secondary outcomes included the change in pure-tone average hearing thresholds over time and the incidence of adverse events .
RESULTS	In the IGF-1 group , 66.7 % ( 95 % confidence interval [ CI ] , 52.9-78 .6 % ) of the patients showed hearing improvement compared to 53.6 % ( 95 % CI , 39.7-67 .0 % ) of the patients in the Dex group ( P = 0.109 ) .
RESULTS	The difference in changes in pure-tone average hearing thresholds over time between the two treatments was statistically significant ( P = 0.003 ) .
RESULTS	No serious adverse events were observed in either treatment group .
RESULTS	Tympanic membrane perforation did not persist in any patient in the IGF-1 group , but did persist in 15.5 % ( 95 % CI , 7.3-27 .4 % ) of the patients in the Dex group ( P = 0.001 ) .
CONCLUSIONS	The positive effect of topical IGF-1 application on hearing levels and its favorable safety profile suggest utility for topical IGF-1 therapy in patients with sudden deafness .
BACKGROUND	UMIN Clinical Trials Registry Number UMIN000004366 , October 30th , 2010 .

###25130998
BACKGROUND	Findings from the randomised phase 3 NeoALTTO trial in women with HER2-positive early breast cancer showed that the combination of lapatinib and trastuzumab significantly improved rates of pathological complete response compared with either drug alone .
BACKGROUND	Here , we report data for the prespecified secondary endpoints of event-free and overall survival , and assess the association between these outcomes and pathological complete response .
METHODS	We enrolled women with HER2-positive early breast cancer and randomly assigned them to receive oral lapatinib ( 1500 mg ) , intravenous trastuzumab ( 4 mg/kg loading dose followed by 2 mg/kg ) , or lapatinib ( 1000 mg ) plus trastuzumab ( same dose as for single agent ) in combination for 6 weeks , followed by an additional 12 weeks of the assigned anti-HER2 therapy in combination with weekly paclitaxel ( 80 mg/m ( 2 ) ) .
METHODS	Definitive surgery was done 4 weeks after the last dose of paclitaxel .
METHODS	After surgery , women received three cycles of FEC ( fluorouracil 500 mg/m ( 2 ) plus epirubicin 100 mg/m ( 2 ) plus cyclophosphamide 500 mg/m ( 2 ) ) given intravenously every 3 weeks , followed by 34 weeks of the same assigned neoadjuvant anti-HER2 therapy .
METHODS	The primary endpoint was pathological complete response .
METHODS	Secondary endpoints included event-free and overall survival ( intention-to-treat analysis ) , and the association between pathological complete response and event-free or overall survival ( analysed by landmark analysis at 30 weeks after randomisation ) .
METHODS	Follow-up is ongoing , and the trial is registered with ClinicalTrials.gov , number NCT00553358 .
RESULTS	455 patients were enrolled : 154 ( 34 % ) were assigned to the lapatinib group , 149 ( 33 % ) to the trastuzumab group , and 152 ( 33 % ) to the lapatinib plus trastuzumab group .
RESULTS	At an event follow-up of 377 years ( IQR 350-422 ) , 3-year event-free survival was 78 % ( 95 % CI 70-84 ) in the lapatinib group , 76 % ( 68-82 ) in the trastuzumab group , and 84 % ( 77-89 ) in the combination group .
RESULTS	Event-free survival did not differ between the lapatinib and trastuzumab groups ( HR 106 , 95 % CI 066-169 , p = 081 ) , nor between the combination and trastuzumab groups ( 078 , 047-128 , p = 033 ) .
RESULTS	Median survival follow-up was 384 years ( IQR 360-424 ) , and 3-year overall survival was 93 % ( 95 % CI 87-96 ) for lapatinib , 90 % ( 84-94 ) for trastuzumab , and 95 % ( 90-98 ) for combination therapy .
RESULTS	Overall survival did not significantly differ between the lapatinib and trastuzumab groups ( HR 086 , 95 % CI 045-163 , p = 065 ) , nor between the combination and trastuzumab groups ( 062 , 030-125 , p = 019 ) .
RESULTS	Landmark analyses showed that 3-year event-free survival was significantly improved for women who achieved pathological complete response compared with those who did not ( HR 038 , 95 % CI 022-063 , p = 00003 ) , as was 3-year overall survival ( 035 , 015-070 , p = 0005 ) .
RESULTS	Adverse events occurred in 149 ( 99 % ) patients receiving lapatinib , 142 ( 96 % ) patients receiving trastuzumab , and 147 ( 99 % ) patients receiving combination therapy .
RESULTS	The most common adverse events were diarrhoea , rash or erythema , hepatic adverse events , and neutropenia ( not related to FEC administration ) , and were consistent with known safety profiles of lapatinib and trastuzumab .
RESULTS	Three primary and eight secondary cardiac events occurred , with no significant difference in incidence between treatment groups for primary or any cardiac events .
CONCLUSIONS	Although event-free survival or overall survival did not differ between treatment groups , findings from our study confirm that patients who achieve pathological complete response after neoadjuvant anti-HER2 therapy have longer event-free and overall survival than do patients without pathological complete response .
BACKGROUND	GlaxoSmithKline .

###24345080
OBJECTIVE	The anti-oxidant and proangiogenic protein haptoglobin ( Hp ) is believed to be important for implantation and pregnancy , although its specific role is not known .
OBJECTIVE	The three phenotypes ( 1-1 , 2-1 and 2-2 ) differ in structure and function .
OBJECTIVE	Hp 2-2 is associated with increased vascular stiffness in other populations .
OBJECTIVE	We examined whether Hp phenotype is associated with abnormal uterine artery Doppler ( UAD ) in pregnancy .
METHODS	We conducted a secondary analysis of a preeclampsia prediction cohort nested within a larger placebo-controlled randomized clinical trial of antioxidants for prevention of preeclampsia .
METHODS	We determined Hp phenotype in 2184 women who completed UAD assessments at 17 weeks gestation .
METHODS	Women with notching were re-evaluated for persistent notching at 24 weeks ' gestation .
METHODS	Logistic regression was used to assess differences in UAD indices between phenotype groups .
RESULTS	Hp phenotype did not significantly influence the odds of having any notch ( p = 0.32 ) , bilateral notches ( p = 0.72 ) , or a resistance index ( p = 0.28 ) or pulsatility index ( p = 0.67 ) above the 90th percentile at 17 weeks ' gestation .
RESULTS	Hp phenotype also did not influence the odds of persistent notching at 24 weeks ( p = 0.25 ) .
CONCLUSIONS	Hp phenotype is not associated with abnormal UAD at 17 weeks ' gestation or with persistent notching at 24 weeks .

###24486835
BACKGROUND	Nitrous oxide ( N2O ) offers both hypnotic and analgesic characteristics .
BACKGROUND	We therefore tested the hypothesis that N2O administration decreases the amount of propofol and remifentanil given by a closed-loop automated controller to maintain a similar bispectral index ( BIS ) .
METHODS	In a randomized multicentre double-blind study , patients undergoing elective surgery were randomly assigned to breathe 60 % inspired N2O ( N2O group ) or 40 % oxygen ( AIR group ) .
METHODS	Anaesthesia depth was evaluated by the proportion of time where BIS was within the range of 40-60 ( BIS40-60 ) .
METHODS	The primary outcomes were propofol and remifentanil consumption , with reductions of 20 % in either being considered clinically important .
RESULTS	A total of 302 patients were randomized to the N2O group and 299 to the AIR group .
RESULTS	At similar BIS40-60 [ 79 ( 67-86 ) % vs 76 ( 65-85 ) % ] , N2O slightly decreased propofol consumption [ 4.5 ( 3.7-5 .5 ) vs 4.8 ( 4.0-5 .9 ) mg kg ( -1 ) h ( -1 ) , P = 0.032 ] , but not remifentanil consumption [ 0.17 ( 0.12-0 .23 ) vs 0.18 ( 0.14-0 .24 ) g kg ( -1 ) min ( -1 ) ] .
RESULTS	For the subgroups of men , at similar BIS40-60 [ 80 ( 72-88 ) % vs 80 ( 70-87 ) % ] , propofol [ 4.2 ( 3.4-5 .3 ) vs 4.4 ( 3.6-5 .4 ) mg kg ( -1 ) h ( -1 ) ] and remifentanil [ 0.19 ( 0.13-0 .25 ) vs 0.18 ( 0.15-0 .23 ) g kg ( -1 ) min ( -1 ) ] consumptions were similar in the N2O vs AIR group , respectively .
RESULTS	For the subgroups of women , at similar BIS40-60 [ 76 ( 64-84 ) % vs 72 ( 62-82 ) % ] , propofol [ 4.7 ( 4.0-5 .8 ) vs 5.3 ( 4.5-6 .6 ) mg kg ( -1 ) h ( -1 ) , P = 0.004 ] and remifentanil [ 0.18 ( 0.13-0 .25 ) vs 0.20 ( 0.15-0 .27 ) g kg ( -1 ) min ( -1 ) , P = 0.029 ] consumptions decreased with the co-administration of N2O .
CONCLUSIONS	With automated drug administration titrated to comparable BIS , N2O only slightly reduced propofol consumption and did not reduce remifentanil consumption .
CONCLUSIONS	There was a minor gender dependence , but not by a clinically important amount .
CONCLUSIONS	Clinical trial registration This study was registered at ClinicalTrials.gov , number NCT00547209 .

###25564179
BACKGROUND	Pain control in pediatric patients undergoing tonsillectomy remains a dilemma .
BACKGROUND	Tramadol and ketamine are reported to be an effective analgesic .
OBJECTIVE	To evaluate the effect of peritonsillar infiltration of tramadol in combination with ketamine versus peritonsillar infiltration of tramadol posttonsillectomy .
METHODS	Specialty hospital in Jordan .
METHODS	Sixty children , aged 7-12 years , selected for tonsillectomy were enrolled in the study .
METHODS	We divided the patients into two groups 30 of each , Group I : received peritonsillar saline and peritonsillar infiltration of tramadol 2 mg/kg , Group II : received peritonsillar infiltration of ketamine 1.0 mg/kg added to peritonsillar tramadol 2 mg/kg .
METHODS	Hemodynamic stability , pain scale , first request of analgesia , total analgesics consumption and post-operative nausea and vomiting ( PONV ) side effects were recorded 24 h after surgery .
RESULTS	The analysis of data showed that Group II had significantly lower face pain scale , longer time for first request of analgesia , and better hemodynamic stability than GI ( p < 0.001 ) .
RESULTS	On the other hand the total analgesics requirements , time of surgery , and PONV showed no significant differences between the two groups .
CONCLUSIONS	Combined use of peritonsillar infiltration of ketamine 1.0 mg/kg with tramadol 2 mg/kg provided prolong analgesic effects , less pain with no side effect , and better hemodynamic stability compared with using tramadol alone in patients undergoing tonsillectomy .

###24800919
OBJECTIVE	Pediatric patients with acute lymphoblastic leukemia ( ALL ) are treated with oral 6-mercaptopurine ( 6MP ) for nearly 2 years , but no pediatric formulation has been available .
OBJECTIVE	In this study , an oral 6MP liquid suitable for pediatric use was developed and tested in the target population .
METHODS	A randomized cross-over study was performed in 20 pediatric ALL patients ( age 1.9 - 14.6 years ) , comparing pharmacokinetics and pharmacodynamics of a newly developed 6MP liquid formulation to 6MP capsules , both taken orally for 4 weeks .
RESULTS	Based upon trough levels of the principal active metabolite,6-thioguanine nucleotides ( 6-TGN ) , a relative bioavailability of the liquid vs. capsules of 1.01 was found ( 90 % CI 0.86 - 1.20 ) , demonstrating bioequivalence .
RESULTS	This was supported by the similarly observed 6MP dosages needed for leucocyte depletion , for both formulations ( 35 mg/day ( range 10 - 115 mg ) ) .
RESULTS	75 % of the parents/patients ( p = 0.005 ) preferred the oral liquid over the capsules because of the ease of administration .
CONCLUSIONS	We conclude that the novel 6MP liquid is a promising treatment for ALL .

###24634444
OBJECTIVE	To analyse treatment effects of eccentric vs. concentric graded exercise in chronic tennis elbow .
METHODS	Randomized controlled trial .
METHODS	Primary care in Uppsala County , Sweden .
METHODS	A total of 120 subjects with tennis elbow lasting more than three months were recruited from primary care and by advertisement .
METHODS	Eccentric ( n = 60 ) or concentric exercise ( n = 60 ) , by lowering or lifting a weight , at home daily , for three months with gradually increasing load .
METHODS	Pain during muscle contraction and muscle elongation , as well as strength , was assessed at baseline and after one , two , three , six , and 12 months .
METHODS	Function and quality of life was assessed at baseline and after three , six and 12 months .
RESULTS	The eccentric exercise group had faster regression of pain , with an average of 10 % higher responder rate at all levels of pain reduction , both during muscle contraction and elongation , ( p < 0.0001 and p = 0.006 , respectively ) .
RESULTS	Significant differences were found in Cox 's analysis from two months onwards ( HR 0.78 , 95 % confidence interval ( CI ) 0.63-0 .96 , p < 0.02 ) .
RESULTS	This represents an absolute pain reduction of 10 % in the eccentric vs. the concentric group and a number-needed-to-treat of 10 .
RESULTS	The eccentric group also had a greater increase of muscle strength than the concentric ( p < 0.02 ) .
RESULTS	The differences persisted throughout the follow-up period .
RESULTS	There were no significant differences between the groups regarding function or quality of life measures .
CONCLUSIONS	Eccentric graded exercise reduced pain and increased muscle strength in chronic tennis elbow more effectively than concentric graded exercise .

###25380344
BACKGROUND	A randomized , double-blind , controlled clinical trial was conducted to evaluate the effectiveness of a propolis rinse on induced gingivitis by using the co-twin study design .
METHODS	Twenty-one twin pairs ( n = 42 ) were enrolled in a gingivitis study with oral hygiene promotion ( 14 days ) and gingivitis induction ( 21 days ) .
METHODS	During the gingivitis induction phase , one member of the twin pair was randomly assigned to a 2 % typified propolis rinse , and the other was assigned a color-matched 0.05 % sodium fluoride plus 0.05 % cetylpyridinium chloride rinse ( positive control ) .
METHODS	Patients rinsed twice daily with 20mL for 30 seconds for 21 days .
METHODS	Gingivitis was measured on days -14 ( baseline ) , 0 ( after hygiene phase ) , and 21 ( after no-hygiene phase ) by using the Papillary Bleeding Score ( PBS ) and by standard digital imaging of the gum tissues ( G-parameter ) .
RESULTS	The 38 persons who completed the study ( age 13-22 years ) were well balanced according to PBS at baseline and G-parameter after the initial hygiene phase .
RESULTS	After 21 days without oral hygiene , the propolis rinse and positive control rinse groups did not differ significantly for average PBS measurements or G-parameter .
CONCLUSIONS	Use of a 2 % typified propolis rinse was equivalent to a positive control rinse during a 21-day no-hygiene period .

###25002723
OBJECTIVE	To report results of a randomized phase II trial ( Radiation Therapy Oncology Group RTOG-0234 ) examining concurrent chemoradiotherapy and cetuximab in the postoperative treatment of patients with squamous cell carcinoma of the head and neck ( SCCHN ) with high-risk pathologic features .
METHODS	Eligibility required pathologic stage III to IV SCCHN with gross total resection showing positive margins and/or extracapsular nodal extension and/or two or more nodal metastases .
METHODS	Patients were randomly assigned to 60 Gy radiation with cetuximab once per week plus either cisplatin 30 mg/m ( 2 ) or docetaxel 15 mg/m ( 2 ) once per week .
RESULTS	Between April 2004 and December 2006 , 238 patients were enrolled .
RESULTS	With a median follow-up of 4.4 years , 2-year overall survival ( OS ) was 69 % for the cisplatin arm and 79 % for the docetaxel arm ; 2-year disease-free survival ( DFS ) was 57 % and 66 % , respectively .
RESULTS	Patients with p16-positive oropharynx tumors showed markedly improved survival outcome relative to patients with p16-negative oropharynx tumors .
RESULTS	Grade 3 to 4 myelosuppression was observed in 28 % of patients in the cisplatin arm and 14 % in the docetaxel arm ; mucositis was observed in 56 % and 54 % , respectively .
RESULTS	DFS in this study was compared with that in the chemoradiotherapy arm of the RTOG-9501 trial ( Phase III Intergroup Trial of Surgery Followed by Radiotherapy Versus Radiochemotherapy for Resectable High Risk Squamous Cell Carcinoma of the Head and Neck ) , which had a hazard ratio of 0.76 for the cisplatin arm versus control ( P = .05 ) and 0.69 for the docetaxel arm versus control ( P = .01 ) , reflecting absolute improvement in 2-year DFS of 2.5 % and 11.1 % , respectively .
CONCLUSIONS	The delivery of postoperative chemoradiotherapy and cetuximab to patients with SCCHN is feasible and tolerated with predictable toxicity .
CONCLUSIONS	The docetaxel regimen shows favorable outcome with improved DFS and OS relative to historical controls and has commenced formal testing in a phase II/III trial .

###25469046
OBJECTIVE	To evaluate the efficacy and safety of the Xiaoyao pill for treatment of functional dyspepsia ( FD ) associated with perimenopausal depression .
METHODS	This was a double-blind , randomized , controlled trial including 180 patients with FD accompanied by depression that were divided into two groups of 90 .
METHODS	Patients in the treatment group received oral administration of the Xiaoyao pill for soothing the liver and activating the spleen , and patients in the control group received a placebo .
METHODS	This trial included an 8-wk therapy period with a follow-up period of 6 mo. .
METHODS	The total efficacy and degree of depression , as assessed by the Hamilton Rating Scale for Depression ( HRSD ) , were evaluated .
METHODS	Plasma levels of motilin and gastrin were measured and a gastric emptying test was conducted in each participant .
RESULTS	The Xiaoyao pill had a good therapeutic effect and improved the symptoms in patients with perimenopausal FD as assessed by the HRSD score , motilin and gastrin levels , and rate of gastric emptying .
RESULTS	The total effective rate of the Xiaoyao pill in the treatment group was significantly superior to that of the placebo in the control group .
RESULTS	In the control group , the initial HRSD score was 12.12 2.29 and decreased to 7.14 1.67 after therapy ( P < 0.01 ) .
RESULTS	In the treatment group , the initial HRSD score was 11.44 2.15 , which significantly decreased to 6.20 2.08 after therapy ( P < 0.01 ) .
RESULTS	Moreover , the HRSD score in the treatment group was significantly lower than in control group after 8 wk ( P < 0.01 ) .
RESULTS	Motilin and gastrin levels in both groups were significantly increased after the 8-wk therapy ( P < 0.05 ) .
RESULTS	The gastric emptying rate was also improved in both groups after therapy ( P < 0.05 ) , and the improvement was significantly better in the treatment group compared to the controls ( P < 0.05 ) .
RESULTS	These results confirm the therapeutic effects of the Xiaoyao pill in perimenopausal FD patients and indicate that it is worthy of clinical promotion .
CONCLUSIONS	The Xiaoyao pill is effective and safe for the treatment of perimenopausal women with FD associated with depression .

###25501721
BACKGROUND	Delay in diagnosis of anaemia during preoperative assessment poses logistic problems , leading to multiple clinic visits , inadequate preoperative management , and unnecessary delay of surgery .
BACKGROUND	Therefore , we tested an instant spectrophotometric haemoglobin ( SpHb ) measurement technique to facilitate this assessment .
METHODS	We evaluated portable instant SpHb vs standard laboratory screening of anaemia between March 2012 and December 2013 .
METHODS	Paired Hb measurements were performed on 726 patients using SpHb ( Pronto-7 , Masimo Corporation , Irvine , CA , USA ) and Hb measured on the same day using an automated analyser .
METHODS	The results were obtained from a group of 638 patients from the pre-anaesthetic clinic with expected normal Hb values , and 88 patients from the oncology clinic with known low Hb .
RESULTS	Median ( range ) SpHb was 129.5 ( 67-171 ) compared with 136 g litre ( -1 ) ( 63-178 ) Hb measured using the automated system .
RESULTS	Identifying Hb below a threshold of 130 g litre ( -1 ) for males had a high sensitivity ( 93 % ) , while identifying a threshold of 120 g litre ( -1 ) for females had lower sensitivity ( 75 % ) .
RESULTS	The specificity for males ( 77 % ) and females ( 81 % ) was similar .
RESULTS	Mean measurement bias and agreement : tolerability interval ratio was -8.1 g litre ( -1 ) and 2.78 for men and -3.1 g litre ( -1 ) and 2.44 for women .
CONCLUSIONS	SpHb was sensitive as a preliminary screening tool for detecting true low Hb values in males , but less sensitive in females .
CONCLUSIONS	Instant SpHb measurement may enable prompt routine preoperative anaemia management , but its precision was lower than expected .
BACKGROUND	This study is approved by the Tasmanian Human Ethics Committee , Australia and was registered prospectively in the Australian and New Zealand Clinical Trials Registry ( http://www.ANZCTR.org.au/ ACTRN12611001256965 ) and the World Health Organization Clinical Trials Registry ( http://apps.who.int/trialsearch/trial.aspx?trialid=ACTRN12611001256965 ) .

###24448992
OBJECTIVE	Hyperhomocysteinemia is a well-known risk factor for vascular disease .
OBJECTIVE	However , its action , mechanism , and role in the acute phase of stroke have not been determined .
OBJECTIVE	We tried to determine whether an association existed between elevated serum homocysteine levels and early neurological deterioration ( END ) in patients with acute ischemic stroke .
METHODS	We performed a secondary analysis from the Cilostazol in Acute Ischemic Stroke Treatment ( CAIST ) trial , which was a double-blinded , randomized , multicenter trial , assessing the noninferiority of cilostazol over aspirin within 48 hours of an acute ischemic stroke .
METHODS	END was defined as an increase of 1 point in motor power or an increase of 2 points in the total National Institute of Health Stroke Scale score within 7 days .
RESULTS	The mean ( SD ) serum homocysteine level was 11.44.7 mol/L .
RESULTS	Of the 396 patients studied , 57 ( 14.4 % ) patients worsened during the 7 days after inclusion .
RESULTS	Most ( 68 % ) of the END cases occurred within the first 24 hours after treatment .
RESULTS	High levels ( > 10.3 mol/L ) of serum homocysteine were independent predictors for END ( third quartile odds ratio , 3.45 ; 95 % confidence intervals , 1.25-9 .50 ; P = 0.016 ; fourth quartile odds ratio , 3.36 ; 95 % confidence intervals 1.18-9 .52 ; P = 0.023 ) in multivariate analysis .
CONCLUSIONS	Patients with acute stroke with elevated serum homocysteine levels are at an increased risk for END .

###25330848
BACKGROUND	Obesity amongst children is a growing problem worldwide .
BACKGROUND	In contrast to adults , little is known on the effects of controlled weight loss on components of the metabolic syndrome in children .
BACKGROUND	The primary aim of the study was to evaluate the effects of a 20-week exercise and diet guidance intervention on body mass index ( BMI ) in a group of overweight children .
BACKGROUND	Our hypothesis was an observed reduction in BMI and secondarily in body fat content , insulin insensitivity , and other components of the metabolic syndrome in the intervention group .
METHODS	School children from Copenhagen were randomly allocated to an intervention group ( n = 19 ) or a control group ( n = 19 ) .
METHODS	Anthropometric assessment , whole body dual-energy X-ray absorptiometry scan , two hours oral glucose tolerance test , steps measured by pedometer , and fitness tests were measured at baseline and at 20weeks .
RESULTS	Thirty-seven children ( 30 girls ) participated at baseline , aged 8.70.9 years with a BMI of 21.83.7 kg/m2 ( meanSD ) , and 36 children completed the study .
RESULTS	The intervention group decreased their BMI ( the intervention effect is the difference in change between the groups adjusted for the respective baseline values ( DELTA ) = -2.0 kg/m2 , 95 % CI : -2.5 ; -1.5 , P < 0.001 ) , total body mass ( DELTA = -4.0 kg , 95 % CI : -4.9 ; -3.0 , P < 0.001 ) , and fat mass ( DELTA = -3.3 kg , 95 % CI : -4.2 ; -2.7 , P < 0.001 ) compared to the control group after the intervention .
RESULTS	The intervention group displayed decreased waist , hip and waist-to-height ratio ( WHtR ) ( all three variables ; P < 0.001 ) , area under curve for plasma insulin ( P < 0.05 ) , and increased mean and minimum steps/day ( P < 0.05 and P < 0.01 , respectively ) .
CONCLUSIONS	The multicomponent intervention had significant favorable effects on BMI , weight , WHtR , mean and minimum steps/day , and fat mass .
CONCLUSIONS	In addition , similar beneficial metabolic effects were found in the children as shown in adults , e.g. increase in peripheral insulin sensitivity .
BACKGROUND	Clinicaltrials.gov Identifier number NCT01660789 .

###24763885
OBJECTIVE	Hyperaminotransferasemia is an important problem in obese patients .
OBJECTIVE	We decide to examine the changes in hyperaminotransferasemia after weight reduction in obese patients with and without NAFLD secondary to a high monounsaturated fat vs. a high polyunsaturated fat hypocaloric diets .
METHODS	A population of 306 obese patients was randomly allocated to two groups : Diet M ( high monounsaturated fat hypocaloric diet ) and Diet P ( high polyunsaturated fat hypocaloric diet ) .
METHODS	Patients were classified as group I ( obese subjects ; n = 262 ) when serum ALT activity was normal or group II ( NAFLD patients ; n = 44 ) when serum ALT activity was ( 43 UI/L ) .
RESULTS	In NAFLD group with diet M , BMI , weight , fat mass , waist circumference , systolic blood pressure , total cholesterol , LDL cholesterol ) , insulin and HOMA-R decreased .
RESULTS	In NAFLD group with diet P , BMI , weight , fat mass , waist circumference , systolic blood pressure , total cholesterol , LDL cholesterol ) , insulin and HOMA-R decreased , too .
RESULTS	In NAFLD group , alanine aminotransferase [ ( diet M ) -20.319.2 UI/L vs. ( diet P ) -14.220.1 UI/L ] , aspartate aminotransferase [ ( diet M ) -11.312.2 UI/L vs. ( diet P ) -11.110.1 UI/L ] , and gammaglutamyl transferase [ ( diet M ) -18.112.2 UI/L vs. ( diet P ) -10.920.1 UI/L ] improved with both diets .
CONCLUSIONS	We showed that weight reduction secondary to two hypocaloric diets was associated with improvement in hypertransaminasemia and insulin resistance in NAFLD patients .

###25742320
OBJECTIVE	To assess whether customised mobile phone reminders would improve adherence to therapy and thus decrease virological failure among HIV infected patients starting antiretroviral treatment ( ART ) .
METHODS	Randomised controlled trial among HIV infected patients initiating antiretroviral treatment .
METHODS	Three diverse healthcare delivery settings in south India : two ambulatory clinics within the Indian national programme and one private HIV healthcare clinic .
METHODS	631 HIV infected , ART nave , adult patients eligible to initiate first line ART were randomly assigned to mobile phone intervention ( n = 315 ) or standard care ( n = 316 ) and followed for 96 weeks .
METHODS	The intervention consisted of customised , interactive , automated voice reminders , and a pictorial message that were sent weekly to the patients ' mobile phones for the duration of the study .
METHODS	The primary outcome was time to virological failure ( viral load > 400 copies/mL on two consecutive measurements ) .
METHODS	Secondary outcomes included ART adherence measured by pill count , death rate , and attrition rate .
METHODS	Suboptimal adherence was defined as mean adherence < 95 % .
RESULTS	Using an intention-to-treat approach we found no observed difference in time to virological failure between the allocation groups : failures in the intervention and standard care arms were 49/315 ( 15.6 % ) and 49/316 ( 15.5 % ) respectively ( unadjusted hazard ratio 0.98 , 95 % confidence interval 0.67 to 1.47 , P = 0.95 ) .
RESULTS	The rate of virological failure in the intervention and standard care groups were 10.52 and 10.73 per 100 person years respectively .
RESULTS	Comparison of suboptimal adherence was similar between both groups ( unadjusted incidence rate ratio 1.24 , 95 % CI 0.93 to 1.65 , P = 0.14 ) .
RESULTS	Incidence proportion of patients with suboptimal adherence was 81/300 ( 27.0 % ) in the intervention arm and 65/299 ( 21.7 % ) in the standard care arm .
RESULTS	The results of analyses adjusted for potential confounders were similar , indicating no significant difference between the allocation groups .
RESULTS	Other secondary outcomes such as death and attrition rates , and subgroup analysis also showed comparable results across allocation groups .
CONCLUSIONS	In this multicentre randomised controlled trial among ART nave patients initiating first line ART within the Indian national programme , we found no significant effect of the mobile phone intervention on either time to virological failure or ART adherence at the end of two years of therapy.Trial registration Current Controlled Trials ISRCTN79261738 .

###25270214
OBJECTIVE	To investigate the changes of B and T lymphocyte attenuator ( BTLA ) , reactive oxygen species ( ROS ) , reactive nitrogen species ( RNS ) , malondialdehyde ( MDA ) , superoxide dismutase ( SOD ) , catalase ( CAT ) , total antioxidative capacity ( TAOC ) in the patients with ankylosing spondylitis ( AS ) and the effect of Xinfeng capsule ( XFC ) on them .
METHODS	AS patients ( n = 140 ) were randomly divided into two groups , XFC group ( 3 tablets each time , tid , n = 70 ) and salicylazosulfapyridine ( SASP ) group ( 4 pills each time , bid , n = 70 ) .
METHODS	Continuous treatment lasts 3 months .
METHODS	The study also enrolled 60 healthy volunteers as a control group .
METHODS	Flow cytometry was used to test BTLA expression .
METHODS	ELISA was performed to detect the oxidative stress indicators ( ROS , RNS , MDA , SOD , CAT , TAOC ) and cytokines ( IL-4 , IL-10 , IL-1 , TNF - ) .
METHODS	Western blotting was adopted to examine the blood sedimentation ( ESR ) .
METHODS	HITACHI 7060 automatic biochemical analyzer was used to determine the level of high sensitive C-reactive protein ( Hs-CRP ) .
RESULTS	Clinical efficacy of XFC group was significantly better than that of SASP group ( P < 0.01 ) .
RESULTS	Compared with the healthy control group , AS patients had significantly lower BTLA expression in CD3 ( + ) T cells and CD4 ( + ) T cells from the peripheral blood ( P < 0.01 or P < 0.05 ) , the decreased levels of SOD , CAT and TAOC , and significantly increased ROS , RNS and MDA values ( P < 0.01 or P < 0.05 ) .
RESULTS	In addition , the levels of serum IL-1 , TNF - , ESR and Hs-CRP were significantly higher ( P < 0.01 ) and IL-4 , IL-10 were significantly lower in AS patients ( P < 0.01 or P < 0.05 ) .
RESULTS	Compared with pre-treatment , both XFC and SASP significantly elevated the expressions of BTLA ( + ) CD3 ( + ) T , BTLA ( + ) CD4 ( + ) T , BTLA , SOD , TAOC , IL-4 , SF-36 ( PF , SF , RP , RE , BP , MH , VT , GH ) eight dimension scores , and reduced ROS , MDA , TNF - , ESR , Hs-CRP , VAS , BASDAI , BASFI and BAS-G in the peripheral blood ( P < 0.01 or P < 0.05 ) .
RESULTS	The differences between XFC group and SASP group were statistically significant ( P < 0.01 or P < 0.05 ) .
RESULTS	Pearson correlation analysis showed that BTLA expression level in the peripheral blood was positively correlated with SOD , RP , BP , SF and RE .
RESULTS	BTLA ( + ) CD3 ( + ) T cells and BTLA * CD4 ( + ) T cells were significantly negatively correlated with ROS , MDA , IL-1 , TNF - , ESR , VAS and BASDAI , and they were positively correlated with TAOC , IL-4 and IL-10 .
RESULTS	BTLA ( + ) CD3 ( + ) T cells were significantly negatively correlated with RNS , Hs-CRP and BASFI ; BTLA ( + ) CD4 ( + ) T cells were positively correlated with CAT .
CONCLUSIONS	XFC can improve BTLA expression in the peripheral blood of AS patients and regulate negatively the activation and proliferation of T cells .

###24732290
OBJECTIVE	Hemolysis , occurring during cardiopulmonary bypass , is associated with lipid peroxidation and postoperative acute kidney injury .
OBJECTIVE	Acetaminophen inhibits lipid peroxidation catalyzed by hemeproteins and in an animal model attenuated rhabdomyolysis-induced acute kidney injury .
OBJECTIVE	This pilot study tests the hypothesis that acetaminophen attenuates lipid peroxidation in children undergoing cardiopulmonary bypass .
METHODS	Single-center prospective randomized double-blinded study .
METHODS	University-affiliated pediatric hospital .
METHODS	Thirty children undergoing elective surgical correction of a congenital heart defect .
METHODS	Patients were randomized to acetaminophen ( OFIRMEV [ acetaminophen ] injection ; Cadence Pharmaceuticals , San Diego , CA ) or placebo every 6 hours for four doses starting before the onset of cardiopulmonary bypass .
RESULTS	Markers of hemolysis , lipid peroxidation ( isofurans and F2-isoprostanes ) , and acute kidney injury were measured throughout the perioperative period .
RESULTS	Cardiopulmonary bypass was associated with a significant increase in free hemoglobin ( from a prebypass level of 9.8 6.2 mg/dL to a peak of 201.5 42.6 mg/dL postbypass ) .
RESULTS	Plasma and urine isofuran and F2-isoprostane concentrations increased significantly during surgery .
RESULTS	The magnitude of increase in plasma isofurans was greater than the magnitude in increase in plasma F2-isoprostanes .
RESULTS	Acetaminophen attenuated the increase in plasma isofurans compared with placebo ( p = 0.02 for effect of study drug ) .
RESULTS	There was no significant effect of acetaminophen on plasma F2-isoprostanes or urinary makers of lipid peroxidation .
RESULTS	Acetaminophen did not affect postoperative creatinine , urinary neutrophil gelatinase-associated lipocalin , or prevalence of acute kidney injury .
CONCLUSIONS	Cardiopulmonary bypass in children is associated with hemolysis and lipid peroxidation .
CONCLUSIONS	Acetaminophen attenuated the increase in plasma isofuran concentrations .
CONCLUSIONS	Future studies are needed to establish whether other therapies that attenuate or prevent the effects of free hemoglobin result in more effective inhibition of lipid peroxidation in patients undergoing cardiopulmonary bypass .

###24836471
BACKGROUND	Propofol , a short-acting hypnotic drug , is increasingly administered by a diverse group of specialists ( e.g. , cardiologists , gastroenterologists ) during diagnostic and therapeutic procedures .
BACKGROUND	Standard monitoring during sedation comprises continuous pulse oximetry with visual assessment of the patient 's breathing pattern .
BACKGROUND	Because undetected hypoventilation is a common pathway for complications , capnographic monitoring of exhaled carbon dioxide has been advocated .
BACKGROUND	We examined whether the use of capnography reduces the incidence of hypoxemia during nonanesthesiologist-administered propofol sedation in patients who did not receive supplemental oxygen routinely .
METHODS	An open , stratified , randomized controlled trial was conducted in 427 healthy adult women during minor gynecology procedures in an outpatient clinic in the Netherlands .
METHODS	Patients were randomly assigned to receive either standard respiratory monitoring ( standard care ) or standard respiratory monitoring combined with capnography ( capnography group ) .
METHODS	To replicate usual clinical practice , capnography monitoring was performed by the same medical team that provided sedation .
METHODS	The primary end point was the incidence of hypoxemia , defined as oxygen saturations < 91 % .
RESULTS	From April 2010 to January 2011 , 427 patients were enrolled .
RESULTS	In the capnography group , 206 patients and in the standard care group , 209 patients were analyzed .
RESULTS	The percentage of patients with a hypoxemic episode was 25.7 % ( 53 of 206 ) in the capnography group and 24.9 % ( 52 of 209 ) in the standard care group , resulting in an absolute difference of 0.8 % ( -7.5 to 9.2 % ) .
CONCLUSIONS	We were unable to confirm an additive role for capnography in preventing hypoxemia during elective nonanesthesiologist-administered propofol ( monotherapy ) sedation in healthy women in whom supplemental oxygen is not routinely administered .
CONCLUSIONS	Based on the confidence interval , the benefit of adding capnography is at most an absolute hypoxemia reduction of 7.5 % , suggesting that adding it in this practice setting to the routine monitoring strategy does not necessarily improve patient safety in daily practice .

###24516879
OBJECTIVE	Long-term pharmacokinetics after supplementation with vitamin D3 or calcifediol ( the 25-hydroxyvitamin D3 metabolite ) is not well studied .
OBJECTIVE	Additionally , it is unclear whether bolus doses of vitamin D3 or calcifediol lead to 25 ( OH ) D3 plasma concentrations considered desirable for fracture prevention ( 30 ng/mL ) .
OBJECTIVE	We therefore investigated plasma pharmacokinetics of 25 ( OH ) D3 during different vitamin D3 and calcifediol supplementation regimens .
METHODS	In this seven-arm , randomized , double-blind , controlled parallel-group study , 35 healthy females aged 5070 years ( 5 per group ) received 20 g calcifediol or vitamin D ( 3 ) daily , 140 g calcifediol or vitamin D ( 3 ) weekly , for 15 weeks , or a single bolus of either 140 g calcifediol , or vitamin D ( 3 ) , or both .
METHODS	25 ( OH ) D3 plasma concentrations were quantified using LCMS/MS in 14 clinical visits among all participants .
RESULTS	For daily ( weekly ) dosing , the area under the concentrationtime curve ( AUC024h ) , which is the measure for exposure , was 28 % ( 67 % ) higher after the first dose of calcifediol than after the first dose of vitamin D3 .
RESULTS	After 15 weeks , this difference was 123 % ( 178 % ) .
RESULTS	All women in the daily and weekly calcifediol groups achieved 25 ( OH ) D3 concentrations > 30 ng/mL ( mean , 16.8 days ) , but only 70 % in the vitamin D3 daily or weekly groups reached this concentration ( mean , 68.4 days ) .
RESULTS	A single dose of 140 g calcifediol led to 117 % higher 25 ( OH ) D3 AUC096h values than 140 g vitamin D3 , while the simultaneous intake of both did not further increase exposure .
CONCLUSIONS	Calcifediol given daily , weekly , or as a single bolus is about 23 times more potent in increasing plasma 25 ( OH ) D3 concentrations than vitamin D3 .
CONCLUSIONS	Plasma 25 ( OH ) D3 concentrations of 30 ng/mL were reached more rapidly and reliably with calcifediol .

###25199060
BACKGROUND	Many patients with severe asthma require regular treatment with oral glucocorticoids despite the use of high-dose inhaled therapy .
BACKGROUND	However , the regular use of systemic glucocorticoids can result in serious and often irreversible adverse effects .
BACKGROUND	Mepolizumab , a humanized monoclonal antibody that binds to and inactivates interleukin-5 , has been shown to reduce asthma exacerbations in patients with severe eosinophilic asthma .
METHODS	In a randomized , double-blind trial involving 135 patients with severe eosinophilic asthma , we compared the glucocorticoid-sparing effect of mepolizumab ( at a dose of 100 mg ) with that of placebo administered subcutaneously every 4 weeks for 20 weeks .
METHODS	The primary outcome was the degree of reduction in the glucocorticoid dose ( 90 to 100 % reduction , 75 to less than 90 % reduction , 50 to less than 75 % reduction , more than 0 to less than 50 % reduction , or no decrease in oral glucocorticoid dose , a lack of asthma control during weeks 20 to 24 , or withdrawal from treatment ) .
METHODS	Other outcomes included the rate of asthma exacerbations , asthma control , and safety .
RESULTS	The likelihood of a reduction in the glucocorticoid-dose stratum was 2.39 times greater in the mepolizumab group than in the placebo group ( 95 % confidence interval , 1.25 to 4.56 ; P = 0.008 ) .
RESULTS	The median percentage reduction from baseline in the glucocorticoid dose was 50 % in the mepolizumab group , as compared with no reduction in the placebo group ( P = 0.007 ) .
RESULTS	Despite receiving a reduced glucocorticoid dose , patients in the mepolizumab group , as compared with those in the placebo group , had a relative reduction of 32 % in the annualized rate of exacerbations ( 1.44 vs. 2.12 , P = 0.04 ) and a reduction of 0.52 points with respect to asthma symptoms ( P = 0.004 ) , as measured on the Asthma Control Questionnaire 5 ( in which the minimal clinically important difference is 0.5 points ) .
RESULTS	The safety profile of mepolizumab was similar to that of placebo .
CONCLUSIONS	In patients requiring daily oral glucocorticoid therapy to maintain asthma control , mepolizumab had a significant glucocorticoid-sparing effect , reduced exacerbations , and improved control of asthma symptoms .
CONCLUSIONS	( Funded by GlaxoSmithKline ; SIRIUS ClinicalTrials.gov number , NCT01691508 . )

###25273343
BACKGROUND	Longer duration of first-line chemotherapy for patients with metastatic breast cancer is associated with prolonged overall survival and improved progression-free survival .
BACKGROUND	We investigated capecitabine added to maintenance bevacizumab after initial treatment with bevacizumab and docetaxel in this setting .
METHODS	We did this open-label randomised phase 3 trial at 54 hospitals in Brazil , China , Egypt , France , Hong Kong , India , Italy , Poland , Spain , and Turkey .
METHODS	We enrolled patients with HER2-negative measurable metastatic breast cancer ; each received three to six cycles of first-line bevacizumab ( 15 mg/kg ) and docetaxel ( 75-100 mg/m ( 2 ) ) every 3 weeks .
METHODS	Progression-free patients were randomly assigned with an interactive voice-response system by block ( size four ) randomisation ( 1:1 ) to receive either bevacizumab and capecitabine or bevacizumab only ( bevacizumab 15 mg/kg on day 1 ; capecitabine 1000 mg/m ( 2 ) twice per day on days 1-14 , every 3 weeks ) until progression , stratified by oestrogen receptor status ( positive vs negative ) , visceral metastases ( present vs absent ) , response status ( stable disease vs response vs non-measurable ) , and lactate dehydrogenase concentration ( 15 vs > 15upper limit of normal ) .
METHODS	Neither patients nor investigators were masked to allocation .
METHODS	The primary endpoint was progression-free survival ( from randomisation ) in the intention-to-treat population .
METHODS	This trial is registered with ClinicalTrials.gov , NCT00929240 .
RESULTS	Between July 16 , 2009 , and March 7 , 2011 ( when enrolment was prematurely terminated ) , 284 patients received initial bevacizumab and docetaxel ; 185 ( 65 % ) were randomly assigned ( 91 to bevacizumab and capecitabine versus 94 to bevacizumab only ) .
RESULTS	Progression-free survival was significantly longer in the bevacizumab and capecitabine group than in the bevacizumab only group ( median 119 months [ 95 % CI 98-154 ] vs 43 months [ 39-68 ] ; stratified hazard ratio 038 [ 95 % CI 027-055 ] ; two-sided log-rank p < 00001 ) , as was overall survival ( median 390 months [ 95 % CI 323-not reached ] vs 237 months [ 185-317 ] ; stratified HR 043 [ 95 % CI 026-069 ] ; two-sided log-rank p = 00003 ) .
RESULTS	Results for time to progression were consistent with those for progression-free survival .
RESULTS	78 ( 86 % ) patients in the bevacizumab and capecitabine group and 72 ( 77 % ) in the bevacizumab only group had an objective response .
RESULTS	Clinical benefit was recorded in 92 ( 98 % ) patients in the bevacizumab alone group and 90 ( 99 % ) in the bevacizumab and capecitabine group .
RESULTS	Mean change from baseline in global health score did not differ significantly between groups .
RESULTS	Grade 3 or worse adverse events during the maintenance phase were more common with bevacizumab and capecitabine than with bevacizumab only ( 45 [ 49 % ] of 91 patients vs 25 [ 27 % ] of 92 patients ) .
RESULTS	The most common grade 3 or worse events were hand-foot syndrome ( 28 [ 31 % ] in the bevacizumab and capecitabine group vs none in the bevacizumab alone group ) , hypertension ( eight [ 9 % ] vs three [ 3 % ] ) , and proteinuria ( three [ 3 % ] vs four [ 4 % ] ) .
RESULTS	Serious adverse events were reported by ten ( 11 % ) patients in the bevacizumab and capecitabine group and seven ( 8 % ) patients in the bevacizumab only group .
CONCLUSIONS	Despite prematurely terminated accrual and the lack of information about post-progression treatment , both progression-free survival and overall survival were significantly improved with bevacizumab and capecitabine compared with bevacizumab alone as maintenance treatment .
CONCLUSIONS	These results might inform future maintenance trials and current first-line treatment strategies for HER2-negative metastatic breast cancer .
BACKGROUND	F Hoffmann-La Roche .

###24296342
OBJECTIVE	Facial exercises are a noninvasive alternative to medical approaches to facial rejuvenation .
OBJECTIVE	Logopedists could be involved in providing these exercises .
OBJECTIVE	Little research has been conducted , however , on the effectiveness of exercises for facial rejuvenation .
OBJECTIVE	This study assessed the effectiveness of 4 exercises purportedly reducing wrinkles and sagging of the facial skin .
METHODS	A control group study was conducted with 18 participants , 9 of whom ( the experimental group ) underwent daily training for 7 weeks .
METHODS	Pictures taken before and after 7 weeks of 5 facial areas ( forehead , nasolabial folds , area above the upper lip , jawline and area under the chin ) were evaluated by a panel of laypersons .
METHODS	In addition , the participants of the experimental group evaluated their own pictures .
METHODS	Evaluation included the pairwise presentation of pictures before and after 7 weeks and scoring of the same pictures by means of visual analogue scales in a random presentation .
RESULTS	Only one significant difference was found between the control and experimental group .
RESULTS	In the experimental group , the picture after therapy of the upper lip was more frequently chosen to be the younger-looking one by the panel .
CONCLUSIONS	It can not be concluded that facial exercises are effective .
CONCLUSIONS	More systematic research is needed .

###24561812
OBJECTIVE	Reactive oxygen species are markedly increased after ischemia and play important roles in the mechanism of ischemia-reperfusion injury .
OBJECTIVE	Regulating the oxidative stress response after brain ischemia provides a potential therapeutic strategy .
OBJECTIVE	Quercetin is a natural flavonoid that exhibits antioxidant properties .
OBJECTIVE	However , the mechanisms by which it protects cells are not fully understood .
OBJECTIVE	Exercise training also reduces oxidative stress and enhances brain recovery .
OBJECTIVE	The purpose of this study was to determine whether combined exercise training with quercetin treatment could result in better neuroprotection and functional recovery in rats subjected to brain ischemia .
METHODS	Rats were randomly assigned to the following groups : middle cerebral artery occlusion ( MCAO ) with rest control , MCAO with quercetin , MCAO with exercise , or MCAO with exercise and quercetin .
METHODS	To determine the effect of PI3K/Akt pathway in quercetin and exercise-mediated neuroprotection , two additional groups , a group of MCAO with quercetin and PI3K/Akt inhibitor ( LY294002 ) and a group of MCAO with exercise , quercetin , and PI3K/Akt inhibitor , were added in this study .
METHODS	Motor function was examined at the 24th hour and 14th day post-MCAO .
METHODS	Brain samples were used to measure the expression of antioxidative and antiapoptotic proteins as well as to measure the infarct volume .
RESULTS	Treatment with either exercise or quercetin significantly decreased oxidative stress and infarct volume , increased antioxidative and antiapoptotic signaling , and improved motor function .
RESULTS	Exercise training combined with quercetin treatment resulted in better outcomes than either treatment alone .
RESULTS	PI3K/Akt inhibition eliminated the protective effects of exercise training and quercetin treatment .
CONCLUSIONS	Quercetin enhances exercise-mediated functional recovery after brain ischemia via up-regulation of PI3K/Akt activity to promote antioxidative and antiapoptotic signaling .

###24815417
BACKGROUND	Diclofenac dosing in children for analgesia is currently extrapolated from adult data .
BACKGROUND	Oral diclofenac 1.0 mgkg ( -1 ) is recommended for children aged 1-12years .
BACKGROUND	Analgesic effect from combination diclofenac/acetaminophen is unknown .
METHODS	Children ( n = 151 ) undergoing tonsillectomy ( c. 1995 ) were randomized to receive acetaminophen elixir 40mgkg ( -1 ) before surgery and 20mgkg ( -1 ) rectally at the end of surgery with diclofenac suspension 0.1 mgkg ( -1 ) , 0.5 mgkg ( -1 ) , or 2.0 mgkg ( -1 ) before surgery or placebo .
METHODS	A further 93 children were randomized to receive diclofenac 0.1 mgkg ( -1 ) , 0.5 mgkg ( -1 ) , or 2.0 mgkg ( -1 ) only .
METHODS	Postoperative pain was assessed ( visual analogue score , VAS 0-10 ) at half-hourly intervals from waking until discharge .
METHODS	Data were pooled with those from a further 222 children and 30 adults .
METHODS	One-compartment models with first-order absorption and elimination described the pharmacokinetics of both medicines .
METHODS	Combined drug effects were described using a modified EMAX model with an interaction term .
METHODS	An interval-censored model described the hazard of study dropout .
RESULTS	Analgesia onset had an equilibration half-time of 0.496 h for acetaminophen and 0.23 h for diclofenac .
RESULTS	The maximum effect ( EMAX ) was 4.9 .
RESULTS	The concentration resulting in 50 % of EMAX ( C50 ) was 1.23 mgl ( -1 ) for diclofenac and 13.3 mgl ( -1 ) for acetaminophen .
RESULTS	A peak placebo effect of 6.8 occurred at 4h .
RESULTS	Drug effects were additive .
RESULTS	The hazard of dropping out was related to pain ( hazard ratio of 1.35 per unit change in pain ) .
RESULTS	Diclofenac 1.0 mgkg ( -1 ) with acetaminophen 15mgkg ( -1 ) achieves equivalent analgesia to acetaminophen 30mgkg ( -1 ) .
CONCLUSIONS	Combination therapy can be used to achieve similar analgesia with lower doses of both drugs .

###25106731
OBJECTIVE	The FIRIS study previously demonstrated non-inferiority of IRIS ( irinotecan plus S-1 ) to FOLFIRI ( 5-fluorouracil/leucovorin with irinotecan ) for progression-free survival as the second-line chemotherapy for metastatic colorectal cancer ( mCRC ) as the primary endpoint .
OBJECTIVE	The overall survival ( OS ) data were immature at the time of the primary analysis .
METHODS	Between 30 January 2006 and 29 January 2008 , 426 patients with mCRC who failed in first-line chemotherapy were randomly assigned to receive either FOLFIRI or IRIS .
METHODS	After the primary analysis , the follow-up survey was cut off on 29 July 2010 , and the final OS data were analysed .
RESULTS	With a median follow-up of 39.2 months , the median OS was 17.4 months in the FOLFIRI group and 17.8 months in the IRIS group [ hazard ratio ( HR ) 0.900 ; 95 % confidence interval ( CI ) 0.728-1 .112 ] .
RESULTS	In the pre-planned subgroup of patients who received prior chemotherapy containing oxaliplatin , the median OS was 12.7 months in the FOLFIRI group and 15.3 months in the IRIS group ( HR 0.755 ; 95 % CI 0.580-0 .983 ) .
CONCLUSIONS	IRIS is non-inferior to FOLFIRI for OS as second-line chemotherapy for mCRC .
CONCLUSIONS	IRIS can be an option for second-line chemotherapy of mCRC .
CONCLUSIONS	( ClinicalTrials.gov Number : NCT00284258 ) .

###25526227
BACKGROUND	Hydrocodone/acetaminophen combination analgesics are frequently prescribed for chronic pain management ; however , acetaminophen presents potential hepatotoxicity to patients and thus dose limitations .
BACKGROUND	These opioid medications are also widely abused .
BACKGROUND	Once-daily , single-entity hydrocodone ( Hysingla ER tablets [ HYD ] ) is a novel formulation with abuse-deterrent properties for the management of chronic pain and represents a suitable option for those patients receiving analgesics containing the same opioid analgesic , hydrocodone .
BACKGROUND	This post-hoc analysis evaluated the efficacy and safety of HYD in patients whose primary pre-study analgesic was hydrocodone/acetaminophen analgesics ( 23-31 % of the study populations ) .
METHODS	Data were analyzed from two Phase III trials , a 12-week randomized , placebo-controlled trial ( RCT ) and an open-label , 52-week trial .
METHODS	In both trials , a dose-titration period with HYD was followed by respective periods of fixed-dose double-blind ( randomized controlled trial [ RCT ] ) or open-label , flexible-dose maintenance treatment .
METHODS	Pain intensity was assessed using a numerical rating scale ( 0-10 , 0 = no pain ) .
METHODS	For the RCT , primary and sensitivity analyses of pain scores used different approaches to handle missing data .
METHODS	Safety data for both studies were summarized .
RESULTS	In the RCT , the mean baseline pain score was 7.3 .
RESULTS	Pain relief was greater with HYD than placebo during double-blind treatment .
RESULTS	In the open-label , flexible-dose trial , the majority of patients were maintained on their titrated dose .
RESULTS	Mean baseline pain score was 6.3 , about 57 % of patients completed the 1-year maintenance period , and mean pain scores were between 3.6 and 4.1 during the maintenance period .
RESULTS	Use of supplemental pain medication decreased or was maintained during the maintenance treatment with HYD .
RESULTS	Adverse events in both trials were typical of those associated with opioid analgesics .
CONCLUSIONS	In patients whose primary pretrial analgesic was hydrocodone/acetaminophen combination tablets , single-entity HYD was effective in reducing pain intensity and in maintaining analgesia over time without need for continued dose increase .
CONCLUSIONS	HYD 's safety and tolerability profiles were similar to other opioid analgesics .

###24268614
BACKGROUND	Stability between internal and external biological regulators are essential to stable mood states .
BACKGROUND	However , the literature needs studies investigating the effect of brief psychotherapies in the biological rhythm regularization .
OBJECTIVE	To verify the capacity regulation of biological rhythms in two models of brief psychotherapy for the remission of depressive symptoms .
METHODS	We conducted a randomized clinical trial with young adults aged 18-29 years old who met diagnostic criteria for depression according to the Structured Clinical Interview for DSM ( SCID ) .
METHODS	In order to evaluate the biological rhythm the Biological Rhythm of assessment in Neuropsychiatry ( BRIAN ) interview was used ; whereas the severity of depression was assessed by the Hamilton Depression Rating Scale ( HDRS ) .
METHODS	The psychotherapy models consisted of two cognitive psychotherapies : Cognitive Narrative Therapy ( CNT ) and Cognitive-Behavioral Therapy ( CBT ) .
RESULTS	The sample consisted of 97 randomized into two models of brief psychotherapy .
RESULTS	The patients regulated the biological rhythm from baseline to post-intervention ( p = .001 ) and follow up ( p = .003 ) .
RESULTS	We also found a positive moderate correlation between biological rhythm regularization and remission of the depressive symptoms ( r = .594 ; p < .001 ) .
CONCLUSIONS	The two models of brief psychotherapies were effective in the remission of depressive symptoms as well as the regulation of biological rhythms in the follow-up of 6 months .
CONCLUSIONS	We did not assess genetic , hormonal and neurochemical factors .
CONCLUSIONS	Also , we did not include patients in pharmaceutical treatment , and with severe symptomatology .

###25200559
BACKGROUND	Obesity and overweight are becoming progressively more prevalent worldwide and are independently associated with a significant increase in the risk of cardiovascular diseases .
BACKGROUND	Systemic arterial hypertension is frequently found in association with obesity and contributes significantly to increased cardiovascular risk .
BACKGROUND	We hypothesise that Roux-en-Y gastric bypass ( RYGB ) surgery , a procedure that effectively reduces body weight , can also positively impact blood pressure control in obese and hypertensive individuals .
METHODS	A unicentric , randomised , controlled , unblinded clinical trial .
METHODS	Sixty obese ( body mass index between 30 and 39.9 ) and moderately well controlled hypertensive patients , in use of at least two antihypertensive medications at maximum doses or more than two in moderate doses , will be randomly allocated , using an online , electronic and concealed method , to receive either RYGB plus optimised clinical treatment ( OCT ) or OCT alone .
METHODS	The primary end point is the reduction of antihypertensive medication at 1 and 2 years of follow-up .
METHODS	Data analysis will primarily be conducted on an intention-to-treat basis .
BACKGROUND	The study was approved by the local institutional review board that works in total compliance with the latest version of the Helsinki Declaration , the Good Clinical Practices ( GCP ) , the ` America 's Document ' and the national regulatory laws .
BACKGROUND	Before the beginning of any study-related activities , each study participant is asked to provide a signed informed consent .
BACKGROUND	NCT01784848 .

###24370543
BACKGROUND	We showed in a previous study that pylorus-resecting pancreaticoduodenectomy ( PrPD ) , which divides the stomach adjacent to the pylorus ring , preserves more than 95 % of the stomach and significantly reduced the incidence of delayed gastric emptying ( DGE ) compared with pylorus-preserving pancreaticoduodenectomy ( PpPD ) .
BACKGROUND	However , long-term outcomes of PrPD and the adverse effect of early postoperative DGE on long-term outcomes remain unclear .
METHODS	A total of 130 patients enrolled in a previous study were followed for 24 months after surgery .
METHODS	Primary endpoint was whether PrPD is a better surgical procedure than PpPD regarding long-term outcomes .
RESULTS	Weight loss > grade 2 ( Common Terminology Criteria for Adverse Events , Version 4.03 ) at 24 months after surgery was significantly better in group PrPD ( 16.2 % ) than in group PpPD ( 42.2 % ) ( p = 0.011 ) .
RESULTS	Nutritional status and late postoperative complications were similar for the two groups .
RESULTS	The incidence of weight loss > grade 2 at 24 months was 63.6 % in DGE patients with DGE and 25.3 % in non-DGE patients ( p = 0.010 ) .
RESULTS	T max ( time to peak ( 13 ) CO2 content in ( 13 ) C-acetate breath test ) at 24 months in DGE patients was significantly delayed compared with that in non-DGE patients ( 27.9 22.7 vs. 16.5 10.1 min , p = 0.023 ) .
RESULTS	Serum albumin level at 24 months was higher in non-DGE patients than in those with DGE ( 3.7 0.6 vs. 4.1 0.4 g/dl , p = 0.013 ) .
CONCLUSIONS	PrPD offers long-term outcomes similar to those of PpPD .
CONCLUSIONS	DGE may be associated with weight loss and poor nutritional status in patients with long-term outcomes .

###25308211
BACKGROUND	We previously developed a surface-controlled water-dispersible form of curcumin and named it Theracurmin ( ) ( Theracurmin ; Theravalues , Tokyo , Japan ) .
BACKGROUND	The area under the blood concentration-time curve of Theracurmin in humans was 27-fold higher than that of curcumin powder .
BACKGROUND	We determined the clinical effects of orally administered Theracurmin in patients with knee osteoarthritis during 8 weeks of treatment .
METHODS	Fifty patients with knee osteoarthritis of Kellgren-Lawrence grade II or III and who were aged more than 40 years were enrolled in this randomized , double-blind , placebo-controlled , prospective clinical study .
METHODS	Placebo or Theracurmin containing 180 mg/day of curcumin was administered orally every day for 8 weeks .
METHODS	To monitor adverse events , blood biochemistry analyses were performed before and after 8 weeks of each intervention .
METHODS	The patients ' knee symptoms were evaluated at 0 , 2 , 4 , 6 , and 8 weeks by the Japanese Knee Osteoarthritis Measure , the knee pain visual analog scale ( VAS ) , the knee scoring system of the Japanese Orthopedic Association , and the need for nonsteroidal anti-inflammatory drugs .
RESULTS	At 8 weeks after treatment initiation , knee pain VAS scores were significantly lower in the Theracurmin group than in the placebo group , except in the patients with initial VAS scores of 0.15 or less .
RESULTS	Theracurmin lowered the celecoxib dependence significantly more than placebo .
RESULTS	No major side effects were observed with Theracurmin treatment .
CONCLUSIONS	Theracurmin shows modest potential for the treatment of human knee osteoarthritis .

###25391143
BACKGROUND	In recent years the video game industry has surpassed both the music and video industries in sales .
BACKGROUND	Currently violent video games are among the most popular video games played by consumers , most specifically First-Person Shooters ( FPS ) .
BACKGROUND	Technological advancements in game play experience including the ability to play online has accounted for this increase in popularity .
BACKGROUND	Previous research , utilising the General Aggression Model ( GAM ) , has identified that violent video games increase levels of aggression .
BACKGROUND	Little is known , however , as to the effect of playing a violent video game online .
RESULTS	Participants ( N = 101 ) were randomly assigned to one of four experimental conditions ; neutral video game -- offline , neutral video game -- online , violent video game -- offline and violent video game -- online .
RESULTS	Following this they completed questionnaires to assess their attitudes towards the game and engaged in a chilli sauce paradigm to measure behavioural aggression .
RESULTS	The results identified that participants who played a violent video game exhibited more aggression than those who played a neutral video game .
RESULTS	Furthermore , this main effect was not particularly pronounced when the game was played online .
CONCLUSIONS	These findings suggest that both playing violent video games online and offline compared to playing neutral video games increases aggression .

###24955584
BACKGROUND	Mindfulness Based Stress Reduction ( MBSR ) is a secular form of meditation training .
BACKGROUND	The vast majority of the extant literature investigating the health effects of mindfulness interventions relies on wait-list control comparisons .
BACKGROUND	Previous studies have found that meditation training over several months is associated with improvements in cognitive control and attention .
RESULTS	We used a visual continuous performance task ( CPT ) to test the effects of eight weeks of mindfulness training on sustained attention by comparing MBSR to the Health Enhancement Program ( HEP ) , a structurally equivalent , active control condition in a randomized , longitudinal design ( ClinicalTrials.gov , NCT01301105 ) focusing on a non-clinical population typical of MBSR participants .
RESULTS	Researchers were blind to group assignment .
RESULTS	63 community participants were randomized to either MBSR ( n = 31 ) or HEP ( n = 32 ) .
RESULTS	CPT analyses were conducted on 29 MBSR participants and 25 HEP participants .
RESULTS	We predicted that MBSR would improve visual discrimination ability and sustained attention over time on the CPT compared to HEP , with more home practice associated with greater improvements .
RESULTS	Our hypotheses were not confirmed but we did find some evidence for improved visual discrimination similar to effects in partial replication of other research .
RESULTS	Our study had sufficient power to demonstrate that intervention groups do not differ in their improvement over time in sustained attention performance .
RESULTS	One of our primary predictions concerning the effects of intervention on attentional fatigue was significant but not interpretable .
CONCLUSIONS	Attentional sensitivity is not affected by mindfulness practice as taught in MBSR , but it is unclear whether mindfulness might positively affect another aspect of attention , vigilance .
CONCLUSIONS	These results also highlight the relevant procedural modifications required by future research to correctly investigate the role of sustained attention in similar samples .
BACKGROUND	ClinicalTrials.gov , NCT01301105 .

###24559010
BACKGROUND	There is scarce and inconsistent information about gender-related differences in the hydration of sports persons , as well as about the effects of hydration on performance , especially during indoor sports .
OBJECTIVE	To determine the physiological differences between genders during in indoor physical exercise , with and without hydration .
METHODS	21 spinning sportspeople ( 12 men and 9 women ) participated in three controlled , randomly assigned and non-sequential hydration protocols , including no fluid intake and hydration with plain water or a sports drink ( volume adjusted to each individual every 15 min ) , during 90 min of spinning exercise .
METHODS	The response variables included body mass , body temperature , heart rate and blood pressure .
RESULTS	During exercise without hydration , men and women lost ~ 2 % of body mass , and showed higher body temperature ( ~ 0.2 C ) , blood pressure ( ~ 4 mmHg ) and heart rate ( ~ 7 beats/min ) compared to exercises with hydration .
RESULTS	Body temperature and blood pressure were higher for men than for women during exercise without hydration , differences not observed during exercise with hydration .
RESULTS	Between 42-99 % of variance in body temperature , blood pressure and heart rate could be explained by the physical characteristics of subjects and the work done .
CONCLUSIONS	During exercise with hydration ( either with water or sport drink ) , the physiological response was similar for both genders .
CONCLUSIONS	Exercise without hydration produced physical stress , which could be prevented with either of the fluids ( plain water was sufficient ) .
CONCLUSIONS	Gender differences in the physiological response to spinning ( body temperature , mean blood pressure and heart rate ) can be explained in part by the distinct physical characteristics of each individual .

###25257975
OBJECTIVE	Higher serum urate concentrations predict more favorable prognosis in individuals with Parkinson disease ( PD ) .
OBJECTIVE	The purpose of this study was to test the causality of this association using a Mendelian randomization approach .
METHODS	The study was conducted among participants in DATATOP and PRECEPT , 2 randomized trials among patients with early PD .
METHODS	The 808 patients with available DNA were genotyped for 3 SLC2A9 single nucleotide polymorphisms ( SNPs ) that identify an allele associated with lower urate concentrations , and for selected SNPs in other genes encoding urate transporters that have modest or no effect on serum urate levels .
METHODS	An SLC2A9 score was created based on the total number of minor alleles at the 3 SLC2A9 loci .
METHODS	Primary outcome was disability requiring dopaminergic treatment .
RESULTS	Serum urate concentrations were 0.69 mg/dl lower among individuals with 4 SLC2A9 minor alleles as compared to those with 2 ( p = 0.0002 ) .
RESULTS	The hazard ratio ( HR ) for progression to disability requiring dopaminergic treatment increased with increasing SLC2A9 score ( HR = 1.16 , 95 % confidence interval [ CI ] = 1.00-1 .35 , p = 0.056 ) .
RESULTS	In a comparative analysis , the HR was 1.27 ( 95 % CI = 1.00-1 .61 , p = 0.0497 ) for a 0.5 mg/dl genetically conferred decrease in serum urate , and 1.05 ( 95 % CI = 1.01-1 .10 , p = 0.0133 ) for a 0.5 mg/dl decrease in measured serum urate .
RESULTS	No associations were found between polymorphisms in other genes associated with urate that do not affect serum urate and PD progression .
CONCLUSIONS	This Mendelian randomization analysis adds to the evidence of a causal protective effect of high urate levels .

###24677163
OBJECTIVE	To examine the relationship between perceived discrimination and medication adherence among black people with hypertension and the role of stress and depressive symptoms in this relationship .
OBJECTIVE	Perceived racial discrimination has been associated with poor health outcomes in blacks ; its relationship to medication adherence among hypertensive patients remains untested .
METHODS	We measured perceived racial discrimination at baseline , stress and depressive symptoms at 6 months , and medication adherence at 12 months among patients enrolled in a 30-site cluster-randomized controlled trial testing a patient and physician-targeted intervention to improve blood pressure .
METHODS	A mediational method with bootstrapping ( stratified by site ) confidence intervals was used to estimate the indirect association between perceived discrimination and medication adherence through stress and depression .
RESULTS	Of 1056 patients from 30 sites enrolled in the trial , 463 had complete data on all four measures at 6 and 12 months and were included in the analyses .
RESULTS	Adjusting for clustering , perceived discrimination was associated with poor medication adherence ( B = 0.138 , p = .011 ) at 12 months , and with stress ( B = 2.24 , p = .001 ) and depression ( B = 1.47 , p = .001 ) at 6 months .
RESULTS	When stress and depression were included in the model , there was a 65 % reduction in the total association of perceived discrimination with medication adherence , and the relationship was no longer significant ( B = 0.049 , p = .35 ) .
CONCLUSIONS	Perceived discrimination is associated with poor medication adherence among hypertensive blacks , and stress and depressive symptoms may account for this relationship .
BACKGROUND	clinicaltrials.gov Identifier : NCT00233220 .

###24930176
OBJECTIVE	The objective was to evaluate a configural vital signs ( CVS ) display designed to support rapid detection and identification of physiological deterioration by graphically presenting patient vital signs data .
BACKGROUND	Current display technology in the intensive care unit ( ICU ) is not optimized for fast recognition and identification of physiological changes in patients .
BACKGROUND	To support nurses more effectively , graphical or configural vital signs displays need to be developed and evaluated .
METHODS	A CVS display was developed based on findings from studies of the cognitive work of ICU nurses during patient monitoring .
METHODS	A total of 42 ICU nurses interpreted data presented either in a traditional , numerical format ( n = 21 ) or on the CVS display ( n = 21 ) .
METHODS	Response time and accuracy in clinical data interpretation ( i.e. , identification of patient status ) were assessed across four scenarios .
RESULTS	Data interpretation speed and accuracy improved significantly in the CVS display condition ; for example , in one scenario nurses required only half of the time for data interpretation and showed up to 1.9 times higher accuracy in identifying the patient state compared to the numerical display condition .
CONCLUSIONS	Providing patient information in a configural display with readily visible trends and data variability can improve the speed and accuracy of data interpretation by ICU nurses .
CONCLUSIONS	Although many studies , including this one , support the use of configural displays , the vast majority of ICU monitoring displays still present clinical data in numerical format .
CONCLUSIONS	The introduction of configural displays in clinical monitoring has potential to improve patient safety .

###24507754
OBJECTIVE	This study aims to observe the impact of the temperature of blood transfusion and infusion toward the perioperative cerebral oxygen metabolism and the postoperative cognitive recovery .
METHODS	Eighty patients of knee replacement under epidural and general anesthesia were randomly divided into warming blood transfusion and infusion ( WBI ) group ( n = 40 ) and control group ( n = 40 ) .
METHODS	The changes of nasopharyngeal temperature , middle cerebral artery blood flow , CERO , and SjVO of the two groups were recorded at each time point for the assessment of the postoperative overall quality of recovery and cognitive recovery situation .
RESULTS	The nasopharyngeal temperatures of the two groups at different time points after transfusion were significantly lower than that at T1 , and there was a significant difference between the two groups ( P < 0.05 ) .
RESULTS	The CERO values of the two groups at T3 were significantly higher than at T1 , while the SjVO values were significantly decreased ( P < 0.01 ) .
CONCLUSIONS	The WBI can significantly reduce the occurrence of the perioperative hypothermia , while it has no significant effect toward cerebral oxygen metabolism , postoperative overall recovery , and recovery of cognitive function .

###25243680
OBJECTIVE	To assess the effect of a Screening Tool of Older Persons potentially inappropriate Prescriptions/Screening Tool to Alert doctors to Right Treatment ( STOPP/START ) medication intervention on clinical and economic outcomes .
METHODS	Parallel-group randomized trial .
METHODS	Chronic care geriatric facility .
METHODS	Residents aged 65 and older prescribed with at least one medication ( N = 359 ) were randomized to receive usual pharmaceutical care or undergo medication intervention .
METHODS	Screening medications with STOPP/START criteria followed up with recommendations to the chief physician .
METHODS	The outcome measures assessed at the initiation of the intervention and 1year later were number of hospitalizations and falls , Functional Independence Measure ( FIM ) , quality of life ( measured using the Medical Outcomes Study 12-item Short-Form Health Survey ) , and costs of medications .
RESULTS	The average number of drugs prescribed was significantly lower in the intervention than in the control group after 1year ( P < .001 ) .
RESULTS	The average drug costs in the intervention group decreased by 103 shekels ( US$ 29 ) per participant per month ( P < .001 ) .
RESULTS	The average number of falls in the intervention group dropped significantly ( P = .006 ) .
RESULTS	Rates of hospitalization , FIM scores , and quality of life measurements were similar for both groups .
CONCLUSIONS	Implementation of STOPP/START criteria reduced the number of medications , falls , and costs in a geriatric facility .
CONCLUSIONS	Their incorporation in those and similar settings is recommended .

###25184863
BACKGROUND	The combination melphalan-prednisone-thalidomide ( MPT ) is considered a standard therapy for patients with myeloma who are ineligible for stem-cell transplantation .
BACKGROUND	However , emerging data on the use of lenalidomide and low-dose dexamethasone warrant a prospective comparison of the two approaches .
METHODS	We randomly assigned 1623 patients to lenalidomide and dexamethasone in 28-day cycles until disease progression ( 535 patients ) , to the same combination for 72 weeks ( 18 cycles ; 541 patients ) , or to MPT for 72 weeks ( 547 patients ) .
METHODS	The primary end point was progression-free survival with continuous lenalidomide-dexamethasone versus MPT .
RESULTS	The median progression-free survival was 25.5 months with continuous lenalidomide-dexamethasone , 20.7 months with 18 cycles of lenalidomide-dexamethasone , and 21.2 months with MPT ( hazard ratio for the risk of progression or death , 0.72 for continuous lenalidomide-dexamethasone vs. MPT and 0.70 for continuous lenalidomide-dexamethasone vs. 18 cycles of lenalidomide-dexamethasone ; P < 0.001 for both comparisons ) .
RESULTS	Continuous lenalidomide-dexamethasone was superior to MPT for all secondary efficacy end points , including overall survival ( at the interim analysis ) .
RESULTS	Overall survival at 4 years was 59 % with continuous lenalidomide-dexamethasone , 56 % with 18 cycles of lenalidomide-dexamethasone , and 51 % with MPT .
RESULTS	Grade 3 or 4 adverse events were somewhat less frequent with continuous lenalidomide-dexamethasone than with MPT ( 70 % vs. 78 % ) .
RESULTS	As compared with MPT , continuous lenalidomide-dexamethasone was associated with fewer hematologic and neurologic toxic events , a moderate increase in infections , and fewer second primary hematologic cancers .
CONCLUSIONS	As compared with MPT , continuous lenalidomide-dexamethasone given until disease progression was associated with a significant improvement in progression-free survival , with an overall survival benefit at the interim analysis , among patients with newly diagnosed multiple myeloma who were ineligible for stem-cell transplantation .
CONCLUSIONS	( Funded by Intergroupe , Francophone du Mylome and Celgene ; FIRST ClinicalTrials.gov number , NCT00689936 ; European Union Drug Regulating Authorities Clinical Trials number , 2007-004823-39 . )

###25172514
OBJECTIVE	To determine the effect of implementation of the Integrated Management of Neonatal and Childhood Illness strategy on treatment seeking practices and on neonatal and infant morbidity .
METHODS	Cluster randomised trial .
METHODS	Haryana , India .
METHODS	29,667 births in nine intervention clusters and 30,813 births in nine control clusters .
METHODS	The pre-specified outcome was the effect on treatment seeking practices .
METHODS	Post hoc exploratory analyses assessed morbidity , hospital admission , post-neonatal infant care , and nutritional status outcomes .
METHODS	The Integrated Management of Neonatal and Childhood Illness intervention included home visits by community health workers , improved case management of sick children , and strengthening of health systems .
METHODS	Outcomes were ascertained through interviews with randomly selected caregivers : 6204 , 3073 , and 2045 in intervention clusters and 6163 , 3048 , and 2017 in control clusters at ages 29 days , 6 months , and 12 months , respectively .
RESULTS	In the intervention cluster , treatment was sought more often from an appropriate provider for severe neonatal illness ( risk ratio 1.76 , 95 % confidence interval 1.38 to 2.24 ) , for local neonatal infection ( 4.86 , 3.80 to 6.21 ) , and for diarrhoea at 6 months ( 1.96 , 1.38 to 2.79 ) and 12 months ( 1.22 , 1.06 to 1.42 ) and pneumonia at 6 months ( 2.09 , 1.31 to 3.33 ) and 12 months ( 1.44 , 1.00 to 2.08 ) .
RESULTS	Intervention mothers reported fewer episodes of severe neonatal illness ( risk ratio 0.82 , 0.67 to 0.99 ) and lower prevalence of diarrhoea ( 0.71 , 0.60 to 0.83 ) and pneumonia ( 0.73 , 0.52 to 1.04 ) in the two weeks preceding the 6 month interview and of diarrhoea ( 0.63 , 0.49 to 0.80 ) and pneumonia ( 0.60 , 0.46 to 0.78 ) in the two weeks preceding the 12 month interview .
RESULTS	Infants in the intervention clusters were more likely to still be exclusively breast fed in the sixth month of life ( risk ratio 3.19 , 2.67 to 3.81 ) .
CONCLUSIONS	Implementation of the Integrated Management of Neonatal and Childhood Illness programme was associated with timely treatment seeking from appropriate providers and reduced morbidity , a likely explanation for the reduction in mortality observed following implementation of the programme in this study.Trial registration Clinical trials NCT00474981 ; ICMR Clinical Trial Registry CTRI/2009/091 / 000715 .

###24524389
BACKGROUND	We have already reported that , for patients undergoing elective colon cancer operations , perioperative infection can be prevented by a single intravenous dose of an antibiotic given immediately beforehand if mechanical bowel preparation and the administration of oral antibiotics are implemented .
BACKGROUND	Synbiotics has been reported to reduce the rate of infection in patients after pancreatic cancer operations .
BACKGROUND	The effectiveness of oral antibiotics and probiotics in preventing postoperative infection in elective colon cancer procedures was examined in a randomized controlled trial .
METHODS	Three hundred ten patients with colon cancer randomly were assigned to one of three groups .
METHODS	All patients underwent mechanical bowel preparation and received a single intravenous dose of flomoxef immediately before operation .
METHODS	Probiotics were administered in Group A ; oral antibiotics were administered in Group B ; and neither probiotics nor oral antibiotics were administered in Group C. Stool samples were collected 9 and 2 days before and 7 and 14 days after the procedure .
METHODS	Clostridium difficile toxin and the number of bacteria in the intestine were determined .
RESULTS	The rates of incisional surgical-site infection were 18.0 % , 6.1 % , and 17.9 % in Groups A , B , and C , and the rates of leakage were 12.0 % , 1.0 % , and 7.4 % in Groups A , B , and C , respectively , indicating that both rates were lesser in Group B than in Groups A and C ( P = .014 and P = .004 , respectively ) .
RESULTS	The detection rates of C. difficile toxin were not changed among the three groups .
CONCLUSIONS	We recommend oral antibiotics , rather than probiotics , as bowel preparation for elective colon cancer procedures to prevent surgical-site infections .

###24345204
OBJECTIVE	Orthodontic appliances can promote accumulation of dental plaque , with associated enamel decalcification or gingival inflammation .
OBJECTIVE	The aim of this study was to examine longer-term microbiological changes during orthodontic treatment with fixed appliances .
METHODS	Twenty-four orthodontic patients aged 11-14 years undergoing fixed appliance therapy were recruited into the study .
METHODS	Each was randomized for cross-mouth assignment of molar bands and bonded molar tubes to contralateral quadrants of the mouth .
METHODS	All patients received self-ligating brackets , but again using randomization , one upper lateral incisor bracket ( left or right ) also received an elastomeric ligature .
METHODS	Plaque samples from the molars and upper lateral incisors were obtained at intervals during treatment and up to 1 year after appliance removal .
METHODS	Denaturing gradient gel electrophoresis and 16S rDNA microarray were used to compare plaque microbial fingerprints .
RESULTS	Plaque populations changed within 3 months of commencing treatment at all sites .
RESULTS	The greatest differences in plaque composition were seen with self-ligating brackets with an elastomeric ligature .
RESULTS	Post-treatment plaque associated with both types of molar attachment contained increased levels of periodontal pathogens Porphyromonas gingivalis , Tannerella forsythia , and Eubacterium nodatum , while Campylobacter rectus , Parvimonas micra , and Actinomyces odontolyticus were also elevated with bonds .
CONCLUSIONS	The results suggest that orthodontic treatment may cause sustained changes in plaque microbiotas and that molar bond-associated plaque may have raised disease potential .

###24708443
BACKGROUND	Oral corticosteroids were used to control stable chronic obstructive pulmonary disease ( COPD ) decades ago .
BACKGROUND	However , recent guidelines do not recommend long-term oral corticosteroids ( LTOC ) use for stable COPD patients , partly because it causes side-effects such as respiratory muscle deterioration and immunosuppression .
BACKGROUND	Nonetheless , the impact of LTOC on life prognosis for stable COPD patients has not been clarified .
METHODS	We used the data of patients randomized to non-surgery treatment in the National Emphysema Treatment Trial .
METHODS	Severe and very severe stable COPD patients who were eligible for volume reduction surgery were recruited at 17 clinical centers in the United States and randomized during 1998-2002 .
METHODS	Patients were followed-up for at least five years .
METHODS	Hazard ratios for death by LTOC were estimated by three models using Cox proportional hazard analysis and propensity score matching .
RESULTS	The pre-matching cohort comprised 444 patients ( prescription of LTOC : 23.0 % .
RESULTS	Age : 66.65.4 year old .
RESULTS	Female : 35.6 % .
RESULTS	Percent predicted forced expiratory volume in one second : 27.07.1 % .
RESULTS	Mortality during follow-up : 67.1 % ) .
RESULTS	Hazard ratio using a multiple-variable Cox model in the pre-matching cohort was 1.54 ( P = 0.001 ) .
RESULTS	Propensity score matching was conducted with 26 parameters ( C-statics : 0.73 ) .
RESULTS	The propensity-matched cohort comprised of 65 LTOC ( + ) cases and 195 LTOC ( - ) cases ( prescription of LTOC : 25.0 % .
RESULTS	Age : 66.55.3 year old .
RESULTS	Female : 35.4 % .
RESULTS	Percent predicted forced expiratory volume in one second : 26.16.8 % .
RESULTS	Mortality during follow-up : 71.3 % ) .
RESULTS	No parameters differed between cohorts .
RESULTS	The hazard ratio using a single-variable Cox model in the propensity-score-matched cohort was 1.50 ( P = 0.013 ) .
RESULTS	The hazard ratio using a multiple-variable Cox model in the propensity-score-matched cohort was 1.73 ( P = 0.001 ) .
CONCLUSIONS	LTOC may increase the mortality of stable severe and very severe COPD patients .

###25346332
BACKGROUND	Induction methods for therapeutic cooling are under investigated .
BACKGROUND	We compared the effectiveness and safety of cold infusions ( CI ) and nasopharyngeal cooling ( NPC ) for cooling induction in stroke patients .
METHODS	A prospective , open-label , randomised ( 1:1 ) , single-centre pilot trial with partially blinded safety endpoint assessment was conducted at the neurointensive care unit of Heidelberg University .
METHODS	Intubated stroke patients with an indication for therapeutic cooling and an intracranial pressure ( ICP ) / temperature brain probe were randomly assigned to CI ( 4C , 2L at 4L/h ) or NPC ( 60L/min for 1 h ) .
METHODS	Previous data suggested a maximum decrease of tympanic temperature for CI ( 2.1 L within 35 min ) after 52 min .
METHODS	Therefore the study period was 1 hour ( 15 min subperiods I-IV ) .
METHODS	The brain temperature course was the primary endpoint .
METHODS	Secondary measures included continuous monitoring of neurovital parameters and extracerebral temperatures .
METHODS	Statistical analysis based on repeated-measures analysis of variance .
RESULTS	Of 221 patients screened , 20 were randomized within 5 months .
RESULTS	Infusion time of 2L CI was 334 min in 10 patients and 10 patients received NPC for 60 min .
RESULTS	During active treatment ( first 30 min ) , brain temperature decreased faster with CI than during NPC ( I : -0.31 0.2 versus -0.12 0.1 C , P = 0.008 ; II : -1.0 0.3 versus -0.49 0.3 C , P = 0.001 ) .
RESULTS	In the CI-group , after the infusion was finished , the intervention no longer decreased brain temperature , which increased after 3.53.3 min .
RESULTS	Oesophageal temperature correlated best with brain temperature during CI and NPC .
RESULTS	Tympanic temperature reacted similarly to relative changes of brain temperature during CI , but absolute values slightly differed .
RESULTS	CI provoked three severe adverse events during subperiods II-IV ( two systolic arterial pressure ( SAP ) , one shivering ) compared with four in the NPC-group , all during subperiod I ( three SAP , one ICP ) .
RESULTS	Classified as possibly intervention-related , two cases of ventilator failure occurred during NPC .
CONCLUSIONS	In intubated stroke patients , brain cooling is faster during CI than during NPC .
CONCLUSIONS	Importantly , contrary to previous expectations , brain cooling stopped soon after CI cessation .
CONCLUSIONS	Oesophageal but neither bladder nor rectal temperature is suited as surrogate for brain temperature during CI and NPC .
CONCLUSIONS	Several severe adverse events in CI and in NPC demand further studying of safety .
BACKGROUND	ClinicalTrials.gov NCT01573117 .
BACKGROUND	Registered 31 March 2012 .

###25886377
BACKGROUND	Despite widespread popularity , text messaging has rarely been used for data collection in clinical research .
BACKGROUND	This paper reports on the development , feasibility , acceptability , validity , and discriminant utility of a single item depression rating scale , delivered weekly via an automated SMS system , as part of a large randomised controlled trial .
METHODS	755 depressed patients ( BDI-II score 20 ) were recruited from primary care into a randomised trial of acupuncture versus counselling or usual care , and invited to opt into a repeated-measures text messaging sub-study .
METHODS	Two weeks following random allocation , trial participants were sent a weekly text message for 15 weeks .
METHODS	Texts were a single question asking , on a scale from 1 to 9 , the extent to which they felt depressed .
METHODS	Feasibility and acceptability of the automated SMS system were evaluated according to cost , ease of implementation , proportion consenting , response rates , and qualitative feedback .
METHODS	Concurrent validity was estimated by correlating SMS responses with the Patient Health Questionnaire ( PHQ-9 ) .
METHODS	SMS responses were compared between groups over time to explore treatment effects .
RESULTS	527 ( 69.8 % ) trial participants consented to the texting sub-study , of whom 498 ( 94.5 % ) responded to at least one message .
RESULTS	Participants provided a valid response to an average of 12.5 messages .
RESULTS	Invalid responses accounted for 1.1 % of texts .
RESULTS	The automated SMS system was quick to set-up , inexpensive , and well received .
RESULTS	Comparison of PHQ-9 and SMS responses at 3 months demonstrated a moderate to high degree of agreement ( Kendall 's tau-b = 0.57 , p < 0.0001 , n = 220 ) .
RESULTS	SMS depression scores over the 15 weeks differed significantly between trial arms ( p = 0.007 ) , with participants allocated to the acupuncture and counselling arms reporting improved depression outcomes compared to usual GP care alone , which reached statistical significance ten weeks after randomisation .
RESULTS	Overall , the single item SMS scale also appeared more responsive to changes in depression , resulting from treatment , than the PHQ-9 .
CONCLUSIONS	Automated SMS systems offer a feasible and acceptable means of monitoring depression within clinical research .
CONCLUSIONS	This study provides clear evidence to support the regular use of a simple SMS scale as a sensitive and valid outcome measure of depression within future randomised controlled trials .
BACKGROUND	Current Controlled Trials - ISRCTN63787732 http://www.controlled-trials.com/ISRCTN63787732/ACUDEP Date of registration : 15/12/2009 .

###25022125
OBJECTIVE	To explore the effectiveness and safety of transcutaneous electrical acupoint stimulation ( TEAS ) combined with infusion of propofol in anodynia bronchoscopy .
METHODS	Ninety patients who received selective bronchoscopy were randomized into a group of compound TEAS with infusion of propofol ( group A ) , a group of compound fentanyl with propofol ( group B ) and a group of simple propofol ( group C ) .
METHODS	In group A , the plaster electrode stimulation was applied at bilateral Hegu ( LI 4 ) , Laogong ( PC 8 ) , Neiguan ( PC 6 ) and Waiguan ( TE 5 ) .
METHODS	The anesthesia was induced after 20 min of stimulation till the end of examination .
METHODS	In group B and group C , the electric stimulation was not adopted .
METHODS	In group B , before anesthesia , fentanyl 1 microg/kg was injected intravenously .
METHODS	Afterwards , the intravenous infusion of propofol was used in the the three groups for anesthesia .
METHODS	The mean arterial pressure ( MAP ) , heart rate ( HR ) , saturation of pulse oximetry ( SpO2 ) and respiratory rate ( RR ) were recorded at different time points .
METHODS	The induced dosage and total dosage of propofol , examination time , the awakening time and adverse reactions were observed in the patients of each group .
RESULTS	The difference in examination time was not significant among the three groups ( P > 0.05 ) .
RESULTS	The postoperative awakening time in group A was earlier than that in group B and group C [ ( 220.3 + / - 110.5 ) s vs ( 285.6 + / - 109.4 ) s , ( 290.1 + / - 105.1 ) s , both P < 0.05 ] .
RESULTS	The total dosage of propofol in group C was larger than those in group A and group B [ ( 288.5 + / - 26.7 ) mg vs ( 225.1 + / - 30.2 ) mg , ( 230.4 + / - 29.3 ) mg , both P < 0.05 ] .
RESULTS	The induced dosage in group C was larger than those in group A and group B [ ( 193.7 + / - 42.3 ) mg vs ( 152.3 + / - 36.1 ) mg , ( 155.4 + / - 40.5 ) mg , both P < 0.05 ] .
RESULTS	Every life physical sign in group A during examination was more stable as compared with that in group B and group C.
RESULTS	The incidence of hypotension and bradycardia in group A were lower than those in group C [ 3.3 % ( 1/30 ) vs 26.7 % ( 8/30 ) , 0 % ( 0/30 ) vs 20.0 % ( 6/30 ) , both P < 0.05 ] .
RESULTS	The adverse incidence of oxygen supply in group A was lower than that in group B [ 6.7 % ( 2/30 ) vs 33.3 % ( 10/30 ) , P < 0.05 ] .
RESULTS	Intraoperative awareness and improper memory did not happen in postoperative investigation .
CONCLUSIONS	In the transcutaneous electrical acupoint stimulation combined with infusion of propofol in anodynia bronchoscopy , the physical sign of patient is stable with less adverse reactions .
CONCLUSIONS	This method reduces anesthetic dosage and shortens the postoperative awakening time , which can be effectively applied in bronchoscopy .

###26104939
OBJECTIVE	The purpose of this study was to assess the association between positive post-radiation therapy ( RT ) biopsy results and subsequent clinical outcomes in males with localized prostate cancer .
METHODS	Radiation Therapy Oncology Group study 94-08 analyzed 1979 males with prostate cancer , stage T1b-T2b and prostate-specific antigen concentrations of 20 ng/dL , to investigate whether 4 months of total androgen suppression ( TAS ) added to RT improved survival compared to RT alone .
METHODS	Patients randomized to receive TAS received flutamide with luteinizing hormone releasing hormone ( LHRH ) agonist .
METHODS	According to protocol , patients without evidence of clinical recurrence or initiation of additional endocrine therapy underwent repeat prostate biopsy 2 years after RT completion .
METHODS	Statistical analysis was performed to evaluate the impact of positive post-RT biopsy results on clinical outcomes .
RESULTS	A total of 831 patients underwent post-RT biopsy , 398 were treated with RT alone and 433 with RT plus TAS .
RESULTS	Patients with positive post-RT biopsy results had higher rates of biochemical failure ( hazard ratio [ HR ] = 1.7 ; 95 % confidence interval [ CI ] = 1.3-2 .1 ) and distant metastasis ( HR = 2.4 ; 95 % CI = 1.3-4 .4 ) and inferior disease-specific survival ( HR = 3.8 ; 95 % CI = 1.9-7 .5 ) .
RESULTS	Positive biopsy results remained predictive of such outcomes after correction for potential confounders such as Gleason score , tumor stage , and TAS administration .
RESULTS	Prior TAS therapy did not prevent elevated risk of adverse outcome in the setting of post-RT positive biopsy results .
RESULTS	Patients with Gleason score 7 with a positive biopsy result additionally had inferior overall survival compared to those with a negative biopsy result ( HR = 1.56 ; 95 % CI = 1.04-2 .35 ) .
CONCLUSIONS	Positive post-RT biopsy is associated with increased rates of distant metastases and inferior disease-specific survival in patients treated with definitive RT and was associated with inferior overall survival in patients with high-grade tumors .

###25545810
OBJECTIVE	To compare the extent of bleeding and patient discomfort during packing removal of three different polyvinyl alcohol ( PVA ) packs : 1 ) a standard PVA sponge ( s-PVA ) ( Mondocel Standard 10 cm ; Mondomed NV , Hamont-Achel , Belgium ) ; 2 ) a PVA sponge with oxidized cellulose ( oc-PVA ) ( Merocel Hemox 10 cm ; Medtronic Xomed Surgical Products , Jacksonville , FL ) ; and 3 ) a PVA sponge with polyethylene film ( pf-PVA ) ( Merocel 2000 8 cm ; Medtronic Xomed Surgical Products , Jacksonville , FL ) , after functional endoscopic sinus surgery and inferior turbinoplasty .
METHODS	A prospective , randomized , blinded , controlled trial .
METHODS	Ninety consecutive patients were enrolled and randomized to receive in each side one pack in the middle meatus and another pack of the same material in the nasal fossa .
METHODS	The patients were equally divided in three groups of 30 patients each .
METHODS	Group A received the pf-PVA ; group B received oc-PVA ; and group C received s-PVA .
METHODS	Postoperatively , bleeding after removal of the entire nasal packing was evaluated by an observer , whereas the severity of pain was rated by patients with visual analog scales .
RESULTS	Our study evaluated three nasal packing materials , demonstrating that the pf-PVA is less painful than the others but with intermediate bleeding ratio .
RESULTS	However , the oc-PVA has an intermediate pain score but minimum bleeding .
RESULTS	The s-PVA showed the worst pain and bleeding results .
CONCLUSIONS	Considering that removal of the second pack ( middle meatus ) is more painful than the first ( nasal fossa ) , our results suggest that a pf-PVA can be placed in the middle meatus and a oc-PVA in the nasal fossa in order to reduce patient 's discomfort in terms of pain and bleeding .
METHODS	1b .

###25085230
OBJECTIVE	To compare patency and overall survival achieved with covered versus uncovered metallic stents among patients with inoperable malignant extrahepatic biliary obstruction .
METHODS	There were 40 patients enrolled in this prospective randomized study between January 2012 and July 2013 .
METHODS	Mean age of patients was 62.6 years ( range , 43-86 y ) .
METHODS	The malignancies causing extrahepatic biliary obstruction were pancreatic cancer ( n = 18 ) , stomach cancer ( n = 13 ) , gallbladder cancer ( n = 3 ) , common bile duct cancer ( n = 2 ) , and other cancer types ( n = 4 ) .
METHODS	Uncovered ( n = 20 ) and covered ( n = 20 ) stents were used .
METHODS	Stent patency , overall survival , and complications were evaluated and statistically compared .
RESULTS	Mean patency of uncovered stents ( 413.3 d 63.0 ) was significantly longer than mean patency of covered ones ( 207.5 d 46.0 ; P = .041 ) .
RESULTS	Mean overall survival was 359.9 days 61.5 for uncovered stents , which was statistically similar to survival of 350.5 days 43.8 for covered stents ( P = .271 ) .
RESULTS	Causes of recurrent obstruction included tumor ingrowth ( n = 2 ) , tumor overgrowth ( n = 5 ) , debris or food material ( n = 5 ) , and stent migration ( n = 2 ) .
RESULTS	One case of acute cholecystitis occurred in covered stent group .
CONCLUSIONS	Uncovered metallic stents had superior patency duration than covered stents for patients with malignant extrahepatic biliary obstruction .
CONCLUSIONS	However , the overall complication and survival rates achieved with covered and uncovered stents were similar .

###25427182
OBJECTIVE	To evaluate the clinical and microbiological effects of neodymium : yttrium-aluminum-garnet laser therapy as an adjunct to scaling and root planing during the hygienic phase .
METHODS	In eight patients , sites with a mean probing pocket depth ( PPD ) of 5 mm were treated by either scaling and root planing ( n = 28 ) ( control ) or by scaling and root planing and adjunctive laser therapy ( n = 28 ) ( power : 5W ) .
METHODS	Re-evaluation was at 4-6 weeks .
METHODS	Thereafter , remaining pockets ( mean PPD 5 mm ) were eliminated by either laser surgery ( power : 7 W ) or gingivectomy ( control ) .
RESULTS	At baseline , the mean PPD of sites originally presenting with a mean PPD 4 mm were 4.69 and 4.73 mm in the test and control sites , respectively .
RESULTS	Six months following surgery , there was a similar average mean PPD reduction in the test ( 1.18 mm , P < 0.01 ) and control sites ( 1.35 mm , P < 0.01 ) .
RESULTS	Also , the reduction in bleeding on probing in both groups was statistically significant ( P < 0.01 , paired t-tests ) .
RESULTS	No statistically-significant differences between the test and control sites were found for any clinical or microbiological parameters at baseline , after initial , and 3 or 6 months ' post-surgical therapy .
CONCLUSIONS	During the hygienic phase , neodymium : yttrium-aluminum-garnet ( 1064 nm ) laser treatment yielded no superiority in clinical efficacy compared to conventional debridement .
CONCLUSIONS	Laser gingivectomy resulted in similar treatment outcomes ( mean PPD and bleeding on probing reduction ) , as did conventional gingivectomy .

###25147350
OBJECTIVE	A pilot study to compare the effectiveness of an individual therapy program with the effects of a general physical therapy program .
METHODS	A randomized , single-blind cross-over design .
METHODS	Ten ambulant children with bilateral spastic cerebral palsy , age four to nine years .
METHODS	Participants were randomly assigned into a ten-week individually defined , targeted or a general program , followed by a cross-over .
METHODS	Evaluation was performed using the Gross Motor Function Measure-88 and three-dimensional gait analysis .
METHODS	General outcome parameters were Gross Motor Function Measure-88 scores , time and distance parameters , gait profile score and movement analysis profiles .
METHODS	Individual goal achievement was evaluated using z-scores for gait parameters and Goal Attainment Scale for gross motor function .
RESULTS	No significant changes were observed regarding gross motor function .
RESULTS	Only after individualized therapy , step - and stride-length increased significantly ( p = 0.022 ; p = 0.017 ) .
RESULTS	Change in step-length was higher after the individualized program ( p = 0.045 ) .
RESULTS	Within-group effects were found for the pelvis in transversal plane after the individualized program ( p = 0.047 ) and in coronal plane after the general program ( p = 0.047 ) .
RESULTS	Between-program differences were found for changes in the knee in sagittal plane , in the advantage of the individual program ( p = 0.047 ) .
RESULTS	A median difference in z-score of 0.279 and 0.419 was measured after the general and individualized program , respectively .
RESULTS	Functional goal attainment was higher after the individual therapy program compared with the general program ( 48 to 43.5 ) .
CONCLUSIONS	The results indicate slightly favorable effects towards the individualized program .
CONCLUSIONS	To detect clinically significant changes , future studies require a minimal sample size of 72 to 90 participants .

###24972643
OBJECTIVE	Mental illness stigma is a serious societal problem and a critical impediment to treatment seeking for mentally ill people .
OBJECTIVE	To improve the understanding of mental illness stigma , this study focuses on the simultaneous analysis of people 's aetiological beliefs , attitudes ( i.e. perceived dangerousness and social distance ) , and recommended treatments related to several mental disorders by devising an over-arching latent structure that could explain the relations among these variables .
METHODS	Three hundred and sixty university students randomly received an unlabelled vignette depicting one of six mental disorders to be evaluated on the four variables on a Likert-type scale .
METHODS	A one-factor Latent Class Analysis ( LCA ) model was hypothesized , which comprised the four manifest variables as indicators and the mental disorder as external variable .
RESULTS	The main findings were the following : ( a ) a one-factor LCA model was retrieved ; ( b ) alcohol and drug addictions are the most strongly stigmatized ; ( c ) a realistic opinion about the causes and treatment of schizophrenia , anxiety , bulimia , and depression was associated to lower prejudicial attitudes and social rejection .
CONCLUSIONS	Beyond the general appraisal of mental illness an individual might have , the results generally point to the acknowledgement of the specific features of different diagnostic categories .
CONCLUSIONS	The implications of the present results are discussed in the framework of a better understanding of mental illness stigma .

###24660233
BACKGROUND	We examined data from a Phase 2 trial { NCT00457821 } of ivacaftor , a CFTR potentiator , in cystic fibrosis ( CF ) patients with aG551D mutation to evaluate standardized approaches to sweat chloride measurement and to explore the use of sweat chloride and nasal potential difference ( NPD ) to estimate CFTR activity .
METHODS	Sweat chloride and NPD were secondary endpoints in this placebo-controlled , multicenter trial .
METHODS	Standardization of sweat collection , processing , and analysis was employed for the first time .
METHODS	Sweat chloride and chloride ion transport ( NPD ) were integrated into a model of CFTR activity .
RESULTS	Within-patient sweat chloride determinations showed sufficient precision to detect differences between dose-groups and assess ivacaftor treatment effects .
RESULTS	Analysis of changes in sweat chloride and NPD demonstrated that patients treated with ivacaftor achieved CFTR activity equivalent to approximately 35 % 40 % of normal .
CONCLUSIONS	Sweat chloride is useful in multicenter trials as a biomarker of CFTR activity and to test the effect of CFTR potentiators .

###24736200
OBJECTIVE	This study aims to determine whether vitamin D levels are associated with menopause-related symptoms in older women .
METHODS	A randomly selected subset of 1,407 women , among 26,104 potentially eligible participants of the Women 's Health Initiative Calcium and Vitamin D trial of postmenopausal women aged 51 to 80 years , had 25-hydroxyvitamin D [ 25 ( OH ) D ] levels measured at the Women 's Health Initiative Calcium and Vitamin D trial baseline visit .
METHODS	Information about menopause-related symptoms at baseline was obtained by questionnaire and included overall number of symptoms and composite measures of sleep disturbance , emotional well-being , and energy/fatigue , as well as individual symptoms .
METHODS	After exclusions for missing data , 530 women ( mean [ SD ] age , 66.2 [ 6.8 ] y ) were included in these analyses .
RESULTS	Borderline significant associations between 25 ( OH ) D levels and total number of menopausal symptoms were observed ( with P values ranging from 0.05 to 0.06 for fully adjusted models ) ; however , the effect was clinically insignificant and disappeared with correction for multiple testing .
RESULTS	No associations between 25 ( OH ) D levels and composite measures of sleep disturbance , emotional well-being , or energy/fatigue were observed ( P 's > 0.10 for fully adjusted models ) .
CONCLUSIONS	There is no evidence for a clinically important association between serum 25 ( OH ) D levels and menopause-related symptoms in postmenopausal women .

###24267622
OBJECTIVE	Hypothermia in patients undergoing major clean surgery results in higher incidence of perioperative complications .
OBJECTIVE	The aim of this study was to evaluate whether the additional use of a thermal reflective blanket can prevent hypothermia in patients undergoing primary unilateral total hip or knee replacement surgery .
METHODS	A randomized , single-blinded study design was used .
METHODS	A total of 58 patients were randomized , 29 received a thermal reflective blanket , and 29 did not .
METHODS	Outcome measures included core temperature , thermal comfort , and shivering .
RESULTS	The mean of the lowest core temperature was below 36C in both the groups ( 35.90.4 C vs 35.80.4 C ) ; thermal comfort and shivering were not significantly different between the groups .
CONCLUSIONS	A thermal reflective blanket did not prevent hypothermia in this group of patients .

###24511614
OBJECTIVE	Labelling of food from fast food restaurants at point-of-purchase has been suggested as one strategy to reduce population energy consumption and contribute to reductions in obesity prevalence .
OBJECTIVE	The aim of this study was to examine the effects of energy and single traffic light labelling systems on the energy content of child and adult intended food purchases .
METHODS	The study employed a randomised controlled trial design .
METHODS	English speaking parents of children aged between three and 12 years were recruited from an existing research cohort .
METHODS	Participants were mailed one of three hypothetical fast food menus .
METHODS	Menus differed in their labelling technique either energy labels , single traffic light labels , or a no-label control .
METHODS	Participants then completed a telephone survey which assessed intended food purchases for both adult and child .
METHODS	The primary trial outcome was total energy of intended food purchase .
RESULTS	A total of 329 participants completed the follow-up telephone interview .
RESULTS	Eighty-two percent of the energy labelling group and 96 % of the single traffic light labelling group reported noticing labelling information on their menu .
RESULTS	There were no significant differences in total energy of intended purchases of parents , or intended purchases made by parents for children , between the menu labelling groups , or between menu labelling groups by socio-demographic subgroups .
CONCLUSIONS	This study provided no evidence to suggest that energy labelling or single traffic light labelling alone were effective in reducing the energy of fast food items selected from hypothetical fast food menus for purchase .
CONCLUSIONS	Additional complementary public health initiatives promoting the consumption of healthier foods identified by labelling , and which target other key drivers of menu item selection in this setting may be required .

###25379541
BACKGROUND	The local anaesthetics used in day-case spinal anaesthesia should provide short recovery times .
BACKGROUND	We aimed to compare hyperbaric prilocaine and bupivacaine in terms of sensory block resolution and time to home readiness in day-case spinal anaesthesia .
BACKGROUND	MeTHODS : Fifty patients undergoing perianal surgery were randomized into two groups .
BACKGROUND	The bupivacaine-fentanyl group ( Group B ) received 7.5 mg , 0.5 % hyperbaric bupivacaine + 20 g fentanyl in total 1.9 mL .
BACKGROUND	The prilocaine-fentanyl group ( Group P ) received 30 mg , 0.5 % hyperbaric prilocaine + 20 g fentanyl in the same volume .
RESULTS	Time to L1 block and maximum block was shorter in Group P than in Group B ( Group P 4.6 1.3 min versus Group B 5.9 01.9 min , P = 0.017 , and Group P 13.2 7.5 min versus Group B 15.3 6.6 min , P = 0.04 ) .
RESULTS	The time to L1 regression and S3 regression of the sensorial block was significantly shorter in Group P than in Group B ( 45.7 21.9 min versus 59.7 20.9 min , P = 0.024 , and 133.8 41.4 min versus 200.4 64.8 min , P < 0.001 ) .
RESULTS	The mean time to home readiness was shorter for Group P than for Group B ( 155 100.2 min versus 207.2 62.7 min ( P < 0.001 ) ) .
CONCLUSIONS	Day-case spinal anaesthesia with hyperbaric prilocaine + fentanyl is superior to hyperbaric bupivacaine in terms of earlier sensory block resolution and home readiness and the surgical conditions are comparable for perianal surgery .

###24569127
BACKGROUND	The present randomized study was designed to compare the efficacy between two active vitamin D analogs , alfacalcidol ( ACD ) and maxacalcitol ( OCT ) , for the management of mild secondary hyperparathyroidism ( SHPT ) in dialysis patients .
METHODS	SHPT in all 32 patients analyzed in the study was initially treated with OCT. .
METHODS	Once patients ' intact PTH levels decreased to the target range of 150 - 180 pg/mL , they were randomized either to switch to ACD at 0.5 g/day ( n = 14 ) , or to remain on an effectively unchanged dose of OCT ( n = 13 ) .
METHODS	Phosphate , calcium , and intact PTH levels were measured every 2 weeks for 12 weeks and vitamin D doses were changed according to target ranges of phosphate ( 3.5 - 6.0 mg/dL ) , calcium ( albuminadjusted calcium : 8.4 - 10.0 mg/dL ) , and intact parathyroid hormone ( 60 - 180 pg/mL ) .
METHODS	Achievement rates of the target ranges of the parameters were estimated .
RESULTS	Baseline calcium levels in the OCT group were significantly higher than in the ACD group .
RESULTS	Changes in achievement rates of target ranges of intact PTH and calcium during the study did not differ significantly between the vitamin D drugs .
RESULTS	Changes in calcium levels in the OCT and ACD groups were similar during the study .
RESULTS	Achievement rates of the target range of phosphate in both groups were also similar until 8 weeks , although the rate in the OCT group declined at 10 weeks .
CONCLUSIONS	The efficacy and safety of OCT for the treatment of mild SHPT are similar to those of ACD in hemodialysis patients .

###24470342
OBJECTIVE	Trimetazidine has been shown to improve angina pectoris and left ventricular ( LV ) function in diabetic patients with ischaemic cardiomyopathy .
OBJECTIVE	The objective of this study was to evaluate the effects of trimetazidine on recurrent angina pectoris and LV structure after drug-eluting stent ( DES ) implantation in elderly multivessel coronary heart disease ( CHD ) patients with diabetes mellitus ( DM ) and a left ventricular ejection fraction ( LVEF ) of 50 % .
METHODS	This was a single-centre , prospective , randomized , double-blind evaluation study .
METHODS	Between January 2010 and September 2010 , 700 CHD patients with DM who were aged 65 years and undergoing coronary angiography at An Zhen Hospital ( Beijing , China ) were recruited and prospectively randomized to receive trimetazidine ( 20 mg three times daily ) or placebo after DES implantation as an addition to conventional CHD treatment .
METHODS	The primary end points were the incidence of recurrent angina pectoris and measures of various echocardiographic parameters , which included LVEF .
RESULTS	At 2-year follow-up , patients in the trimetazidine group ( n = 255 ) showed significant improvements in the incidence ( P = 0.024 ) and severity of angina pectoris , compared with the control group , as well as silent myocardial ischaemia ( P = 0.009 ) and angina pectoris-free survival ( P = 0.011 ) .
RESULTS	LV function and structure in trimetazidine-treated patients were relatively stable at 2-year follow-up , while they deteriorated in the control group ( n = 255 ) with a significant difference between groups ( all P < 0.01 ) .
RESULTS	The E peak to A peak ( E/A ) ratio in trimetazidine-treated patients and in the control group decreased after 2 years ; the E/A ratio in trimetazidine-treated patients was slightly better than that in the control group , without a significant difference ( P = 0.170 ) .
RESULTS	There was no significant difference in event-free survival for the composite end point including death , myocardial infarction , cerebrovascular accident ( P = 0.422 ) and subsequent revascularization ( P = 0.073 ) .
CONCLUSIONS	Adjunctive therapy with trimetazidine after DES implantation can have a beneficial effect on recurrent angina pectoris as well as LV function and structure in elderly multivessel CHD patients with DM .

###24824095
OBJECTIVE	To study the factors affecting long-term treatment results of displaced intraarticular calcaneal fractures ( DIACFs ) .
METHODS	A post hoc analysis .
METHODS	Tertiary care teaching hospitals .
METHODS	Eight to twelve years of results from a randomized controlled multicenter trial of operative versus nonoperative treatment ( n = 56 ) were divided into 2 groups : the superior 50 % results ( n = 28 ) and the inferior 50 % results ( n = 28 ) , regardless of the treatment given .
METHODS	The determinant of this division was a visual analog score for pain and function .
METHODS	The operative treatment consists of open reduction and internal fixation , whereas the nonoperative treatment consists of nonweight bearing and early range of motion exercise .
METHODS	A visual analog score for pain and function , the short-form 36 ( SF-36 ) general health outcome questionnaire , the American Orthopaedic Foot & Ankle Society ( AOFAS ) hindfoot scale , and Olerud-Molander score .
METHODS	We compared age , sex , fracture type ( Sanders classification ) , treatment given , Bhler angle , residual articular surface step-off at healing , type of occupation , and injury insurance between the 2 groups .
RESULTS	Patients of the superior group had higher physical SF-36 , AOFAS , and Olerud-Molander score than in the inferior group .
RESULTS	Operative treatment , better Bhler angle and articular surface restoration , light labor/retirement , and absence of injury insurance were more common in the superior group .
RESULTS	Age , sex , pretreatment Bhler angle , and fracture type were comparable in the superior and inferior groups .
CONCLUSIONS	The decision making for definitive treatment of intraarticular calcaneal fractures is multifactorial with a spectrum of results and trends such as patient demographic features that should be considered in choosing the best treatment option .
METHODS	Prognostic Level II .
METHODS	See Instructions for Authors for a complete description of levels of evidence .

###24560012
BACKGROUND	This phase II study examined the efficacy of mapatumumab in combination with paclitaxel and carboplatin in patients with non-small-cell lung cancer ( NSCLC ) .
METHODS	Patients with stage IIIB or stage IV advanced primary NSCLC were randomly assigned ( 1:1:1 ) to receive up to 6 courses of standard-dose paclitaxel and carboplatin or a combination of paclitaxel , carboplatin , and mapatumumab ( 10 mg/kg or 30 mg/kg ) .
METHODS	Primary efficacy end points were overall response rate and median progression-free survival ( PFS ) .
METHODS	Secondary efficacy end points included disease control rate , overall survival ( OS ) , time to response , and duration of response .
METHODS	Exploratory studies included evaluation of historical biopsy materials for TRAIL-R1 expression by immunohistochemical analysis and serum levels of M30 , a marker of apoptosis , before and after the first 2 doses of mapatumumab .
METHODS	Safety parameters , including adverse events ( AEs ) , laboratory tests , and immunogenicity , were assessed .
RESULTS	The majority of patients had stage IV disease ( 79 % ) and an Eastern Cooperative Oncology Group ( ECOG ) performance status of 0 ( 58 % ) ; baseline characteristics were similar across treatment arms .
RESULTS	No improvements in response or disease control rates , PFS , or OS were gained from the addition of mapatumumab .
RESULTS	Adverse events in the mapatumumab arms were generally consistent with toxicities seen in the carboplatin and paclitaxel control arm .
RESULTS	Levels of M30 were highly variable , and consistent patterns were not seen across treatment arms .
CONCLUSIONS	This study showed no clinical benefit from adding mapatumumab to carboplatin and paclitaxel in unselected patients with NSCLC .
CONCLUSIONS	The combination was generally well tolerated .
CONCLUSIONS	The possibility of subgroups sensitive to mapatumumab is discussed .

###25869371
OBJECTIVE	In the context of a group randomized field trial , we evaluated whether parents who participated in a workplace intervention , designed to increase supervisor support for personal and family life and schedule control , reported significantly more daily time with their children at the 12-month follow-up compared with parents assigned to the Usual Practice group .
OBJECTIVE	We also tested whether the intervention effect was moderated by parent gender , child gender , or child age .
METHODS	The Support-Transform-Achieve-Results Intervention was delivered in an information technology division of a US Fortune 500 company .
METHODS	Participants included 93 parents ( 45 % mothers ) of a randomly selected focal child aged 9 to 17 years ( 49 % daughters ) who completed daily telephone diaries at baseline and 12 months after intervention .
METHODS	During evening telephone calls on 8 consecutive days , parents reported how much time they spent with their child that day .
RESULTS	Parents in the intervention group exhibited a significant increase in parent-child shared time , 39 minutes per day on average , between baseline and the 12-month follow-up .
RESULTS	By contrast , parents in the Usual Practice group averaged 24 fewer minutes with their child per day at the 12-month follow-up .
RESULTS	Intervention effects were evident for mothers but not for fathers and for daughters but not sons .
CONCLUSIONS	The hypothesis that the intervention would improve parents ' daily time with their children was supported .
CONCLUSIONS	Future studies should examine how redesigning work can change the quality of parent-child interactions and activities known to be important for youth health and development .

###25695900
OBJECTIVE	Otolaryngology residents need concise , easily accessible modules to expand educational opportunities between surgical cases .
OBJECTIVE	These modules should be inexpensive to create and improve learning outcomes .
OBJECTIVE	The purpose of this pilot study was to assess whether otolaryngology residents at multiple institutions used online video modules to supplement their studying for the Otolaryngology Training Exam , whether the modules had any effect on their Otolaryngology Training Examination Scores , and to obtain survey feedback about the modules .
METHODS	This randomized trial was conducted in 3 academic departments of otolaryngology in the United States among 37 residents enrolled in 3 otolaryngology residency programs .
METHODS	Residents were randomized into 2 groups , one with access to the educational modules and the other with no access .
METHODS	Otolaryngology training examination scores were obtained from the year prior to the intervention ( 2012 ) and the year following module access ( 2013 ) .
METHODS	Residents with access to the modules were also surveyed to assess use and obtain feedback about the modules .
RESULTS	Otolaryngology training examination scores improved significantly from 2012 to 2013 among both residents who had access to the modules and those who did not in the sections of head and neck , laryngology , and sleep medicine .
RESULTS	However , scores in the sections of pediatric otolaryngology ( 8 % increase , P = .03 ) , otology ( 7 % increase , P = .02 ) , and facial plastic surgery ( 10 % increase , P = .02 ) improved from 2012 to 2013 only among residents with access to the modules .
RESULTS	All respondents rated the videos as very helpful , with a rating of 4 of 5 on a Likert scale .
CONCLUSIONS	Online otolaryngology educational modules are an inexpensive way to expand resident learning opportunities .
CONCLUSIONS	Despite the lack of quantifiable improvement in otolaryngology training examination scores in this study , use of online modules sends a message to otolaryngology residents that their education is a priority ; self-study outside the hospital and clinics is necessary and expected ; and that instructors are willing to try more nontraditional or progressive forms of education to increase resident knowledge .

###24709513
OBJECTIVE	The aim of the present prospective , randomized , controlled , clinical study was to compare the outcomes of periradicular surgery of the maxillary first molar tooth using the vestibular approach between 2 preoperative radiologic evaluation methods : cone beam computed tomography ( CBCT ) and conventional radiography .
METHODS	Periradicular surgery was applied to the maxillary first molar tooth in 40 patients .
METHODS	The patients were divided into 2 groups .
METHODS	The patients in group 1 underwent examination and preoperative planning with CBCT , and the patients in group 2 underwent examination and preoperative planning with conventional radiography .
METHODS	The outcomes of the treatment were evaluated radiographically and clinically , and the data were analyzed statistically .
RESULTS	The mean operative time was significantly shorter in group 1 than in group 2 .
RESULTS	According to the radiographic and clinical healing criteria used in the present study , the healing of patients in group 1 was rated as a success in 35 % , an improvement in 40 % , and a failure in 25 % .
RESULTS	In the group 2 patients , healing was rated as a success in 42.1 % , an improvement in 31.6 % , and a failure in 26.3 % .
RESULTS	Sinus membrane elevation was performed in 92.3 % of all patients .
RESULTS	Sinus membrane perforation occurred in 20 % of the patients in group 1 and 36.8 % of the patients in group 2 .
CONCLUSIONS	Periradicular surgery of maxillary first molars using a vestibular approach is a viable treatment method with a low complication rate .
CONCLUSIONS	Preoperative CBCT examination demonstrated positive contributions to the treatment outcomes .

###24820046
OBJECTIVE	To evaluate safety and visual outcomes after proton beam irradiation ( PBI ) therapy for subfoveal choroidal neovascularisation ( CNV ) secondary to causes other than age-related macular degeneration ( AMD ) .
METHODS	This study is a prospective , unmasked and randomised clinical trial using two dosage regimens , conducted in the Massachusetts Eye and Ear Infirmary .
METHODS	The study included 46 patients with CNV secondary to non-AMD and best-corrected visual acuity of 20/320 or better .
METHODS	Patients were randomly assigned to receive 16 or 24 cobalt gray equivalents ( CGE ) of PBI in two equal fractions .
METHODS	Complete ophthalmological examinations , fundus photography and fluorescein angiography were performed at baseline and 6 , 12 , 18 and 24months after treatment .
RESULTS	At 1year after treatment , 82 % and 72 % lost fewer than 1.5 lines of vision in the 16 CGE and in 24 CGE groups , respectively .
RESULTS	At 2years after therapy , 77 % in the lower dose group and 64 % in the higher dose group lost fewer than 1.5 lines of vision .
RESULTS	Mild radiation complications such as radiation vasculopathy developed in 17.6 % of patients .
CONCLUSIONS	PBI is a safe and efficacious treatment for subfoveal CNV not due to AMD .
CONCLUSIONS	The data with respect to visual outcomes and radiation complications trend in favour of the 16 CGE group , although differences do not reach statistical significance .
CONCLUSIONS	PBI may be considered as an alternative to current therapies .

###26218729
BACKGROUND	Recently , rimabotulinumtoxinB has been increasingly used as an off-label treatment of primary axillary hyperhidrosis ( PAH ) .
BACKGROUND	However , the optimal conversion ratios for onabotulinumtoxinA and rimabotulinumtoxinB remain to be determined .
OBJECTIVE	To compare effectiveness , satisfaction level , and safety of rimabotulinumtoxinB with onabotulinumtoxinA at a conversion ratio of 1:30 for the treatment of PAH .
METHODS	Adults with PAH were enrolled in this bilaterally paired single-subject study .
METHODS	Each patient was randomly treated with 1,500 U rimabotulinumtoxinB on 1 axilla and 50 U onabotulinumtoxinA contralaterally .
METHODS	Hyperhidrosis Disease Severity Scale was assessed before and after treatment up to 20 weeks .
METHODS	A 10-cm visual analog scale representing improvement of hidrotic symptom and starch-iodine test were also used to assess therapeutic efficacy .
RESULTS	Twenty-four patients completed the study .
RESULTS	Both groups showed comparable and efficacious anhidrotic effects through 20 weeks for any variable .
RESULTS	There were no significant differences in terms of the onset of action or mean duration of action between the 2 groups .
RESULTS	Overall satisfaction with the treatment was equally high in both groups .
CONCLUSIONS	Both toxins showed comparable anhidrotic effect for the treatment of axillary hyperhidrosis at a conversion ratio of 1:30 .

###24285122
OBJECTIVE	Video capsule endoscopy ( VCE ) is recommended as the first exploration in obscure digestive bleeding .
OBJECTIVE	The efficiency of the PillCam SB2 ( Given Imaging ) has been widely reported .
OBJECTIVE	The CapsoCam capsule ( Capsovision ) has four cameras allowing the exploration of the small bowel through 360 lateral viewing .
OBJECTIVE	This system does not include a recording system so the capsule has to be retrieved by the patient after expulsion in order for the film to be downloaded .
OBJECTIVE	The aim of this study was to evaluate diagnostic concordance ( kappa value ) of the PillCam SB2 and CapsoCam capsules in the same patients .
METHODS	This was a prospective comparative study in four French referral endoscopy units .
METHODS	Consecutive patients ingested the two capsules 1 hour apart and in a randomized order .
RESULTS	In the 73 included patients there were 13 technical issues ( 11 CapsoCam , 2 PillCam SB2 ) .
RESULTS	Of the 60 patients with analyzable data , and following expert review of all discordant cases , a concordant positive diagnosis was obtained in 23 ( 38.3 % ) and a negative diagnosis was obtained and 26 patients ( 43.3 % ) .
RESULTS	Concordance was good , with a kappa value of 0.63 in analyzable patients , and 46.7 % diagnosis with CapsoCam vs. 48.3 % with PillCam SB2.CapsoCam and PillCam SB2 procedures identified 81.8 % ( 27/33 ) and 84.8 % ( 28/33 ) of positive patients , respectively ( P = 0.791 ) .
RESULTS	In a per lesion analysis , the CapsoCam capsule detected significantly more lesions ( 108 vs. 85 lesions ; P = 0.001 ) .
RESULTS	Reading time was longer for CapsoCam procedures ( 32.0 vs. 26.2 minutes ; P = 0.002 ) .
CONCLUSIONS	This study shows comparable efficiency of the CapsoCam and PillCam SB2 capsule systems in terms of diagnostic yield and image quality .

###24756483
BACKGROUND	The impact of omega-3 polyunsaturated fatty acids ( PUFAs ) for prevention of atrial fibrillation ( AF ) is still part of a lively debate .
BACKGROUND	The present study evaluates the impact of orally administered omega-3 ethyl ester concentrate ( omega-3 PUFA ) on postoperative onset of AF in patients with recent myocardial infarction ( 3 months ) undergoing isolated coronary artery bypass grafting ( CABG ) .
BACKGROUND	Patients and
METHODS	The study included a total of 198 patients with recent ( 3 months ) myocardial infarction .
METHODS	The treatment group consisted of 99 prospectively and randomly assigned patients .
METHODS	A matched control group was generated out of the entirety of patients undergoing isolated CABG during the same time period , being not treated with omega-3 PUFA .
METHODS	Primary endpoint was onset of postoperative AF .
METHODS	Patients of the treatment group received a daily dose of 2g omega-3 PUFA , initiated 5 days before surgery .
METHODS	Effective serum levels were confirmed by laboratory testing .
RESULTS	Patients of the treatment group had less frequently postoperative AF ( treatment : 31.3 % vs. control : 48.0 % ; p = 0.017 ) .
RESULTS	The reduction in relative risk was 34.8 % in the treatment group , which conforms a number needed to treat ( NNT ) of 6.0 patients .
RESULTS	A more pronounced effect with a NNT of 4.1 was observed in patients70 years ( p = 0.007 ) .
RESULTS	Besides , patients of the treatment group had a shorter intensive care unit stay ( p = 0.001 ) and suffered less frequently from impaired wound healing by trend ( p = 0.063 ) .
RESULTS	One patient out of treatment group and two out of control group died during hospital stay ( p = 1.000 ) .
CONCLUSIONS	Preoperative administration of 2g omega-3 PUFA reduces incidence of postoperative AF in patients with recent ( 3 months ) myocardial infarction undergoing isolated CABG .

###24608361
BACKGROUND	Magnesium enhances the effect of rocuronium .
BACKGROUND	Sugammadex reverses rocuronium-induced neuromuscular block .
BACKGROUND	The authors investigated whether magnesium decreased the efficacy of sugammadex for the reversal of rocuronium-induced neuromuscular block .
METHODS	Thirty-two male patients were randomized in a double-blinded manner to receive magnesium sulfate ( MgSO4 ) 60 mg/kg or placebo intravenously before induction of anesthesia with propofol , sufentanil , and rocuronium 0.6 mg/kg .
METHODS	Neuromuscular transmission was monitored using TOF-Watch SX acceleromyography ( Organon Ltd. , Dublin , Ireland ) .
METHODS	In 16 patients , sugammadex 2 mg/kg was administered intravenously at reappearance of the second twitch of the train-of-four ( moderate block ) .
METHODS	In 16 further patients , sugammadex 4 mg/kg was administered intravenously at posttetanic count 1 to 2 ( deep block ) .
METHODS	Primary endpoint was recovery time from injection of sugammadex to normalized train-of-four ratio 0.9 .
METHODS	Secondary endpoint was recovery time to final T1 .
RESULTS	Average time for reversal of moderate block was 1.69 min ( SD , 0.81 ) in patients pretreated with MgSO4 and 1.76 min ( 1.13 ) in those pretreated with placebo ( P = 0.897 ) .
RESULTS	Average time for reversal of deep block was 1.77 min ( 0.83 ) in patients pretreated with MgSO4 and 1.98 min ( 0.58 ) in those pretreated with placebo ( P = 0.572 ) .
RESULTS	Times to final T1 were longer compared with times to normalized train-of-four ratio 0.9 , without any difference between patients pretreated with MgSO4 or placebo .
CONCLUSIONS	Pretreatment with a single intravenous dose of MgSO4 60 mg/kg does not decrease the efficacy of recommended doses of sugammadex for the reversal of a moderate and deep neuromuscular block induced by an intubation dose of rocuronium .

###26465983
BACKGROUND	Systemic glucocorticoids reduce the incidence of bronchopulmonary dysplasia among extremely preterm infants , but they may compromise brain development .
BACKGROUND	The effects of inhaled glucocorticoids on outcomes in these infants are unclear .
METHODS	We randomly assigned 863 infants ( gestational age , 23 weeks 0 days to 27 weeks 6 days ) to early ( within 24 hours after birth ) inhaled budesonide or placebo until they no longer required oxygen and positive-pressure support or until they reached a postmenstrual age of 32 weeks 0 days .
METHODS	The primary outcome was death or bronchopulmonary dysplasia , confirmed by means of standardized oxygen-saturation monitoring , at a postmenstrual age of 36 weeks .
RESULTS	A total of 175 of 437 infants assigned to budesonide for whom adequate data were available ( 40.0 % ) , as compared with 194 of 419 infants assigned to placebo for whom adequate data were available ( 46.3 % ) , died or had bronchopulmonary dysplasia ( relative risk , stratified according to gestational age , 0.86 ; 95 % confidence interval [ CI ] , 0.75 to 1.00 ; P = 0.05 ) .
RESULTS	The incidence of bronchopulmonary dysplasia was 27.8 % in the budesonide group versus 38.0 % in the placebo group ( relative risk , stratified according to gestational age , 0.74 ; 95 % CI , 0.60 to 0.91 ; P = 0.004 ) ; death occurred in 16.9 % and 13.6 % of the patients , respectively ( relative risk , stratified according to gestational age , 1.24 ; 95 % CI , 0.91 to 1.69 ; P = 0.17 ) .
RESULTS	The proportion of infants who required surgical closure of a patent ductus arteriosus was lower in the budesonide group than in the placebo group ( relative risk , stratified according to gestational age , 0.55 ; 95 % CI , 0.36 to 0.83 ; P = 0.004 ) , as was the proportion of infants who required reintubation ( relative risk , stratified according to gestational age , 0.58 ; 95 % CI , 0.35 to 0.96 ; P = 0.03 ) .
RESULTS	Rates of other neonatal illnesses and adverse events were similar in the two groups .
CONCLUSIONS	Among extremely preterm infants , the incidence of bronchopulmonary dysplasia was lower among those who received early inhaled budesonide than among those who received placebo , but the advantage may have been gained at the expense of increased mortality .
CONCLUSIONS	( Funded by the European Union and Chiesi Farmaceutici ; ClinicalTrials.gov number , NCT01035190 . )

###25907488
OBJECTIVE	To observe the impact of Xinkeshu on top of standard medication on psychological stress-related emotional and biophysiological parameters in patients with mental stress-induced myocardial ischemia ( MSIMI ) .
METHODS	A randomized controlled clinical trial was conducted on 40 patients with MSIMI and patients were randomized into treatment group ( n = 21 ) and control group ( n = 19 ) by random number table method .
METHODS	Patients in the treatment group received Xinkeshu ( 12 capsules/d ) on top of standard therapy , and the control group received placebo on top of standard therapy .
METHODS	Serum homocysteine ( Hcy ) , Patient Health Questionnaire-9 ( PHQ-9 ) , Generalized Anxiety Disorder-7 ( GAD-7 ) , left ventricular ejection fraction ( LVEF ) and left ventricular fractional shortening ( LVFS ) were compared between the groups at baseline and after 8 weeks therapy .
RESULTS	( 1 ) Baseline data were similar between the 2 groups ( all P > 0.05 ) .
RESULTS	( 2 ) After 8 weeks , LVFS was significantly increased ( from ( 34.62 5.76 ) % to ( 35.90 4.99 ) % , P = 0.027 ) and serum Hcy ( from ( 18.08 1.81 ) mol/L to ( 16.06 10.10 ) mol/L ) , PHQ-9 ( from 8.14 3.98 to 6.28 2.87 ) and GAD-7 ( from 9.52 4.98 to 6.48 3.84 ) were significantly reduced in treatment group ( all P < 0.05 ) compared to baseline .
RESULTS	In the control group , only GAD-7 was significantly reduced ( from 8.89 5.06 to 6.74 4.80 , P = 0.003 ) after 8 weeks therapy compared to baseline ( P < 0.05 ) while other parameters remained unchanged ( all P > 0.05 ) .
CONCLUSIONS	Xinkeshu on the top of standard therapy can improve the emotional state and left ventricular systolic function in patients with MSIMI .

###24561029
OBJECTIVE	To study the effect of protocolized measurement ( three times daily ) of the Modified Early Warning Score ( MEWS ) versus measurement on indication on the degree of implementation of the Rapid Response System ( RRS ) .
METHODS	A quasi-experimental study was conducted in a University Hospital in Amsterdam between September and November 2011 .
METHODS	Patients who were admitted for at least one overnight stay were included .
METHODS	Wards were randomized to measure the MEWS three times daily ( `` protocolized '' ) versus measuring the MEWS `` when clinically indicated '' in the control group .
METHODS	At the end of each month , for an entire seven-day week , all vital signs recorded for patients were registered .
METHODS	The outcomes were categorized into process measures including the degree of implementation and compliance to set monitoring standards and secondly , outcomes such as the degree of delay in physician notification and Rapid Response Team ( RRT ) activation in patients with raised MEWS ( MEWS3 ) .
RESULTS	MEWS calculations from vital signs occurred in 70 % ( 2513/3585 ) on the protocolized wards versus 2 % ( 65/3013 ) in the control group .
RESULTS	Compliance with the protocolized regime was presents in 68 % ( 819/1205 ) , compliance in the control group was present in 4 % ( 47/1232 ) of the measurements .
RESULTS	There were 90 calls to primary physicians on the protocolized and 9 calls on the control wards .
RESULTS	Additionally on protocolized wards , there were twice as much RRT calls per admission .
CONCLUSIONS	Vital signs and MEWS determination three times daily , results in better detection of physiological abnormalities and more reliable activations of the RRT .

###25169846
BACKGROUND	Influenza virus infection-induced inflammatory responses are associated with fever and other symptoms .
BACKGROUND	Although macrolide antibiotics ( macrolides ) provide anti-inflammatory effects , these effects have not been well studied in influenza patients .
METHODS	We examined the effects of clarithromycin on influenza symptoms .
METHODS	A randomized , prospective , and open-label study was performed between December 2010 and March 2011 and between December 2012 and March 2013 in patients with pandemic A/H1 2009 influenza or seasonal influenza virus infections .
METHODS	Patients aged > 15 years received either neuraminidase inhibitors ( control group ) or clarithromycin plus neuraminidase inhibitors ( clarithromycin group ) .
METHODS	Body temperature and other symptoms were recorded for 5 days after initiating treatment .
METHODS	Serum interleukin ( IL ) -6 and IL-8 levels were also measured .
RESULTS	Herein , 79 patients were enrolled over the two influenza seasons , and data from 63 patients were analyzed .
RESULTS	All patients showed fever and other symptoms , including rhinorrhea ( n = 38 ) , cough ( n = 50 ) , sore throat ( n = 39 ) , arthralgia or myalgia ( n = 46 ) , and general malaise ( n = 50 ) .
RESULTS	Fever duration was approximately 42 % shorter in patients with temperatures 38.5 C ( p = 0.02 ) , decreasing from 42 h to 24 h. Among patients with pandemic influenza infections ( n = 20 ) , the rhinorrhea improvement rate was higher in the clarithromycin group ( p = 0.03 ; 88 % vs. 20 % ) .
RESULTS	Serum IL-6 levels decreased 5 days after treatment , but no differences between the two groups were detected .
CONCLUSIONS	Clarithromycin may have the additional clinical benefit of improving fever , the main symptom of influenza , in patients treated with neuraminidase inhibitors .

###24609851
BACKGROUND	Community-based participatory research ( CBPR ) approaches that involve community and academic partners in activities ranging from protocol design through dissemination of study findings can increase recruitment of medically underserved and underrepresented racial/ethnic minority populations into biomedical research .
METHODS	Five cancer screening and prevention trials in three National Cancer Institute ( Bethesda , MD ) - funded Community Networks Program Centers ( CNPC ) , in Florida , Kansas , and South Carolina , were conducted across diverse populations .
METHODS	Data were collected on total time period of recruitment , ratios of participants enrolled over potential participants approached , selected CBPR strategies , capacity-building development , and systematic procedures for community stakeholder involvement .
RESULTS	Community-engaged approaches used included establishing colearning opportunities , participatory procedures for community-academic involvement , and community and clinical capacity building .
RESULTS	A relatively large proportion of individuals identified for recruitment was actually approached ( between 50 % and 100 % ) .
RESULTS	The proportion of subjects who were eligible among all those approached ranged from 25 % to more than 70 % ( in the community setting ) .
RESULTS	Recruitment rates were very high ( 78 % -100 % of eligible individuals approached ) and the proportion who refused or who were not interested among those approached was very low ( 5 % -11 % ) .
CONCLUSIONS	Recruitment strategies used by the CNPCs were associated with low refusal and high enrollment ratios of potential subjects .
CONCLUSIONS	Adherence to CBPR principles in the spectrum of research activities , from strategic planning to project implementation , has significant potential to increase involvement in biomedical research and improve our ability to make appropriate recommendations for cancer prevention and control programming in underrepresented diverse populations .
CONCLUSIONS	CBPR strategies should be more widely implemented to enhance study recruitment .

###25404126
BACKGROUND	Affecting mother and child , malaria during pregnancy ( MiP ) provokes a double morbidity and mortality burden .
BACKGROUND	Within a package of interventions to prevent MiP in endemic areas , the WHO currently recommends intermittent preventive treatment ( IPTp ) .
BACKGROUND	Concerns about anti-malarial resistance have however prompted interest in intermittent screening and treating ( IST ) as an alternative approach to IPTp .
BACKGROUND	IST involves screening for malaria infection at scheduled antenatal care ( ANC ) clinic visits and treating malaria cases .
BACKGROUND	In light of the need to comprehensively evaluate new interventions prior to roll out , this article explores the acceptability of IST with artemether-lumefantrine ( AL ) compared to IPTp with sulphadoxine-pyrimethamine ( SP ) and in Upper East Region , northern Ghana .
METHODS	Data were collected alongside an open-label , randomized , controlled trial of IST-AL and IPTp-SP in Kassena-Nankana District .
METHODS	Thirty pregnant women enrolled in the clinical trial participated in six focus group discussions .
METHODS	Ten in-depth interviews were carried out with clinical trial staff .
METHODS	Observations were also made at the health facilities where the clinical trial took place .
RESULTS	Trial participants were generally willing to endure the discomfort of the finger prick necessary for a rapid diagnostic test for malaria and this reflected a wider demand for diagnostic techniques .
RESULTS	Reports of side effects were however linked to both trial anti-malarials .
RESULTS	Direct complaints about SP were particularly severe with regard to women 's experience of vomiting .
RESULTS	Although the follow-up treatment doses of AL for IST were not supervised , based on blister inspection and questioning trial , staff were confident about participants ' adherence to the treatment course .
RESULTS	One case of partial adherence to the AL treatment course was reported .
CONCLUSIONS	Despite the discomfort of the finger prick required to perform the intermittent malaria screening , trial participants generally expressed more positive sentiments towards IST-AL than IPTp-SP .
CONCLUSIONS	Nonetheless , questions remain about adherence to a multiple dose anti-malarial regimen during pregnancy , particularly in endemic areas where MiP is often non-symptomatic .
CONCLUSIONS	Any implementation of IST must be accompanied by appropriate health messages on adherence and the necessary training for health staff regarding case management .

###25274220
BACKGROUND	The treatment of patients with varicose veins constitutes a considerable workload and financial burden to the National Health Service .
BACKGROUND	This study aimed to assess the cost-effectiveness of ultrasound-guided foam sclerotherapy ( UGFS ) and endovenous laser ablation ( EVLA ) compared with conventional surgery as treatment for primary varicose veins .
METHODS	Participant cost and utility data were collected alongside the UK CLASS multicentre randomized clinical trial , which compared EVLA , surgery and UGFS .
METHODS	Regression methods were used to estimate the effects of the alternative treatments on costs to the health service and quality-adjusted life-years ( QALYs ) at 6 months .
METHODS	A Markov model , incorporating available evidence on clinical recurrence rates , was developed to extrapolate the trial data over a 5-year time horizon .
RESULTS	Compared with surgery at 6 months , UGFS and EVLA reduced mean costs to the health service by 655 and 160 respectively .
RESULTS	When additional overhead costs associated with theatre use were included , these cost savings increased to 902 and 392 respectively .
RESULTS	UGFS produced 0005 fewer QALYs , whereas EVLA produced 0011 additional QALYs .
RESULTS	Extrapolating to 5 years , EVLA was associated with increased costs and QALYs compared with UGFS ( costing 3640 per QALY gained ) , and generated a cost saving ( 206-439 ) and QALY gain ( 0078 ) compared with surgery .
RESULTS	Applying a ceiling willingness-to-pay ratio of 20 000 per QALY gained , EVLA had the highest probability ( 787 per cent ) of being cost-effective .
CONCLUSIONS	The results suggest , for patients considered eligible for all three treatment options , that EVLA has the highest probability of being cost-effective at accepted thresholds of willingness to pay per QALY .

###24766750
OBJECTIVE	This study investigated whether self-reports of alcohol-related postings on Facebook by oneself or one 's Facebook friends were related to common motives for drinking and were uniquely predictive of self-reported alcohol outcomes ( alcohol consumption , problems , and cravings ) .
METHODS	Pacific Northwest undergraduates completed a survey of alcohol outcomes , drinking motives , and alcohol-related Facebook postings .
METHODS	Participants completed the survey online as part of a larger study on alcohol use and cognitive associations .
METHODS	Participants were randomly selected through the university registrar 's office and consisted of 1,106 undergraduates ( 449 men , 654 women , 2 transgender , 1 declined to answer ) between the ages of 18 and 25 years ( M = 20.40 , SD = 1.60 ) at a large university in the Pacific Northwest .
METHODS	Seven participants were excluded from analyses because of missing or suspect data .
RESULTS	Alcohol-related postings on Facebook were significantly correlated with social , enhancement , conformity , and coping motives for drinking ( all ps < .001 ) .
RESULTS	After drinking motives were controlled for , self-alcohol-related postings independently and positively predicted the number of drinks per week , alcohol-related problems , risk of alcohol use disorders , and alcohol cravings ( all ps < .001 ) .
RESULTS	In contrast , friends ' alcohol-related postings only predicted the risk of alcohol use disorders ( p < .05 ) and marginally predicted alcohol-related problems ( p = .07 ) .
CONCLUSIONS	Posting alcohol-related content on social media platforms such as Facebook is associated with common motivations for drinking and is , in itself , a strong predictive indicator of drinking outcomes independent of drinking motives .
CONCLUSIONS	Moreover , self-related posting activity appears to be more predictive than Facebook friends ' activity .
CONCLUSIONS	These findings suggest that social media platforms may be a useful target for future preventative and intervention efforts .

###24276103
BACKGROUND	We aimed to compare the effectiveness of intravenous piracetam with that of intravenous dimenhydrinate in the treatment of acute peripheral vertigo in the emergency department .
METHODS	This double-blind study comprised a total of 200 patients , aged between 18 and 70 years , who had presented to the emergency department of Ankara Training and Research Hospital and were diagnosed with peripheral vertigo .
METHODS	Evaluation of the severity of the patients ' vertigo was performed using a visual analogue scale , before and after drug administration .
RESULTS	Both drugs were found to be effective ( p < 0.001 ) and had comparable effects ( p < 0.474 ) .
RESULTS	Dimenhydrinate was also found to have about two times the side effects of piracetam .
RESULTS	Drowsiness was found to be the most common side effect of these two drugs .
CONCLUSIONS	Dimenhydrinate and piracetam have similar levels of effectiveness with regard to acute vertigo .
CONCLUSIONS	We conclude that piracetam , which has fewer side effects than dimenhydrinate , better vestibular compensation , and is effective for both acute and chronic vertigo , could be more frequently used in the emergency treatment of acute vertigo .

###24943105
BACKGROUND	Chronic constipation is frequent in children .
BACKGROUND	The objective of this study is to compare the efficacy and safety of PEG 4000 and lactulose for the treatment of chronic constipation in young children .
METHODS	This randomised , double-blind study enrolled 88 young children aged 12 to 36 months , who were randomly assigned to receive lactulose ( 3.3 g per day ) or PEG 4000 ( 8 g per day ) for four weeks .
METHODS	The primary efficacy variable was stool frequency during the fourth week of treatment .
METHODS	Secondary outcomes were the number and frequency of subjective symptoms associated with defecation at each visit .
RESULTS	Stool frequency was comparable in the two groups at baseline ( lactulose : 0.7 0.5 ; PEG 4000 : 0.5 0.55 ) .
RESULTS	Mean stool frequency increased from 0.70 0.50 stools/day at baseline to 0.80 0.41 at Week 4 in the lactulose group and from 0.50 0.55 to 1.10 0.55 stools/day in the PEG 4000 group .
RESULTS	A significant difference was observed in the adjusted mean change from baseline , which was 0.15 stools/day in the lactulose group and 0.51 stools/day in the PEG 4000 group , with a least-squares mean difference of 0.36 stools/day [ 95 % CI : 0.16 to 0.56 ] .
RESULTS	With respect to secondary outcome variables , stool consistency and ease of stool passage improved more in the PEG 4000 group ( p = 0.001 ) .
RESULTS	The incidence of adverse events was similar in both groups , the majority of which were mild .
CONCLUSIONS	PEG 4000 has superior efficacy to lactulose for the treatment of chronic constipation in young children and is well tolerated .
BACKGROUND	US National Institute of Health Clinical Trials database ; study NCT00255372 first registered 17th November 2005 .

###26046730
BACKGROUND	Stem cell-based therapy has emerged as a potential therapy in acute myocardial infarction ( AMI ) .
BACKGROUND	Although various approaches have been studied , intracoronary injection of bone marrow autologous mononuclear cells ( BMMC ) and the ability of granulocyte colony-stimulating factor ( G-CSF ) to mobilize endogenous cells have attracted the most attention .
OBJECTIVE	This study compares , for the first time , the efficacy of BMMC injection , G-CSF mobilization , and the combination of both with standard treatment .
METHODS	On Day 1 after primary percutaneous coronary intervention , 120 patients were randomized to a 1 ) intracoronary BMMC injection ; 2 ) mobilization with G-CSF ; 3 ) both ( BMMC injection plus G-CSF ) ; or 4 ) conventional treatment ( control group ) .
METHODS	G-CSF , 10 g/kg/day subcutaneously , was started Day 1 and maintained for 5 days .
METHODS	BMMC injection was performed on Days 3 to 5 .
METHODS	Our primary endpoint was absolute change in 12-month left ventricular ejection fraction ( LVEF ) and left ventricular end-systolic volume ( LVESV ) relative to baseline measured by cardiac magnetic resonance .
RESULTS	The mean change in LVEF between baseline and follow-up for all patients was 4 6 % ( p = 0.006 ) .
RESULTS	Change in LVEF and LVESV over time did not differ significantly among the 4 groups .
RESULTS	Patients actively treated with any stem cell approach showed similar changes in LVEF and LVESV versus control subjects , with a small but significant reduction in infarct area ( p = 0.038 ) .
CONCLUSIONS	In our study , 3 different bone marrow-derived stem cell approaches in AMI did not result in improvement of LVEF or volumes compared with standard AMI care ( Trial of Hematopoietic Stem Cells in Acute Myocardial Infarction [ TECAM ] ; NCT00984178 ) .

###25100438
BACKGROUND	The impact of anaesthetic agents on cognitive recovery during the first post-operative week in a middle-aged population undergoing general anaesthesia is insufficiently studied .
BACKGROUND	We hypothesised that patients receiving anaesthesia based on desflurane would have a quicker recovery and regain cognitive capacity faster than patients receiving anaesthesia based on propofol .
METHODS	We performed a prospective , randomised , single-blinded study comparing the effects of desflurane and propofol as primary anaesthetic agents on cognitive recovery in 59 American Society of Anesthesiologists Physical Status Classification System I-II women undergoing breast surgery .
METHODS	Cognitive recovery was evaluated using the Cognitive Failure Questionnaire and a modified version of the Post-operative Quality of Recovery Scale .
RESULTS	Post-operative cognitive recovery according to Cognitive Failure Questionnaire was 65 % and 66 % at 72h , and 71 % and 72 % at 1 week for the desflurane and the propofol groups , respectively .
RESULTS	Recovery according to Post-operative Quality of Recovery Scale was 52 % and 50 % at 2h , increasing to 71 % and 87 % at 48h for the desflurane and the propofol groups , respectively .
RESULTS	At the final point of measurement ( Cognitive Failure Questionnaire 1 week , Post-operative Quality of Recovery Scale 48h ) , many of the patients had still not reached their baseline cognitive performance .
RESULTS	There was no difference in overall cognitive recovery between the desflurane and propofol groups .
CONCLUSIONS	Cognitive recovery was not complete 1 week after surgery in any of the groups .
CONCLUSIONS	There was no difference in the rate of cognitive recovery in middle-aged patients receiving desflurane or propofol anaesthesia during ambulatory breast surgery .

###25109581
OBJECTIVE	The purpose of this study was to compare the discomfort and surgical outcomes of a piezosurgery device with those of rotatory instruments in lower third molar extraction .
METHODS	A split-mouth , randomized , unblinded clinical study was designed ; the 2 molars had to have the same extraction difficulty score .
METHODS	The test side was extracted using a piezosurgery technique and the control side was extracted using a conventional handpiece .
METHODS	The primary endpoint was patient discomfort evaluated with the Postoperative Symptom Severity ( PoSSe ) scale , which was administered to each patient ; secondary endpoints were pain , trismus , swelling , and surgical time evaluation .
METHODS	Paired-samples t test and repeated-measures analysis of variance were used to compare outcomes within patients .
RESULTS	Ten consecutive patients ( 6 female , 4 male ; mean age , 22.4 2.3 yr ) were recruited .
RESULTS	The total score on the PoSSe scale was significantly lower for piezosurgery compared with the conventional rotating handpiece ( 24.7 10.3 vs 36.0 7.6 ; t = -4.27 ; P = .002 ) .
RESULTS	Moreover , postoperative swelling 1 week after surgery was significantly lower for piezosurgery than for the conventional rotating handpiece ( 2.75 0.23 vs 3.1 0.39 cm ; t = -2.63 ; P = .027 ) .
CONCLUSIONS	Piezosurgery was associated with less postoperative discomfort and yielded better results for swelling .
CONCLUSIONS	Piezosurgery seems to be a good technique in daily surgical practice , especially if applied in the critical steps in which safety and respect for soft tissue , bone , and nerves are necessary .

###24225325
BACKGROUND	Many strategies have been evaluated to improve the prevention and control of cardiovascular ( CVD ) risk factors .
BACKGROUND	Nursing telephonic and tele-counseling individualized lifestyle educational programs have been found to improve blood pressure control and adherence to lifestyle recommendation .
BACKGROUND	This study tested the efficacy of a nurse-led reminder program through email ( NRP-e ) to improve CVD risk factors among hypertensive adults .
METHODS	All participants received usual CVD prevention and a guideline-based educational program .
METHODS	Subjects in the NRP-e group also received weekly email alerts and phone calls from a nurse care manager for 6 months .
METHODS	Emails contained a reminder program on the need for adherence with a healthy lifestyle based upon current guidelines .
METHODS	Follow-up visits were scheduled at 1 , 3 and 6 months after enrollment ; randomization was made centrally and blood samples were evaluated into a single laboratory .
RESULTS	The final sample consisted of 98 ( control ) and 100 ( NRP-e ) subjects ( mean age 59.0 14.5 years ; 51.0 % males ) .
RESULTS	After 6 months , the following CVD risk factors significantly improved in both groups : body mass index , alcohol and fruit consumption , cigarette smoking , adherence to therapy hours , systolic and diastolic blood pressure , fasting blood glucose , low-density lipoproteins ( LDL ) and total cholesterol , triglycerides , and physical activity .
RESULTS	In the NRP-e group , however , the prevalence of several behaviors or conditions at risk decreased significantly more than in the control group : obesity ( -16 % ) , low fruit consumption ( -24 % ) , uncontrolled hypertension ( -61 % ) , LDL ( -56 % ) , and total cholesterol ( -40 % ) .
CONCLUSIONS	The NRP-e improved a range of CVD risk factors .
CONCLUSIONS	The program had low costs , required only an average of < 20 min per day in addition to normal practice , and may deserve further evaluation for the inclusion among existing care management approaches .

###25414095
BACKGROUND	Epilepsy is the most common neurological problem that affects people with learning disabilities .
BACKGROUND	The high seizure frequency , resistance to treatments , associated skills deficit and co-morbidities make the management of epilepsy particularly challenging for people with learning disabilities .
BACKGROUND	The Books Beyond Words booklet for epilepsy uses images to help people with learning disabilities manage their condition and improve quality of life .
BACKGROUND	Our aim is to conduct a randomized controlled feasibility trial exploring key methodological , design and acceptability issues , in order to subsequently undertake a large-scale randomized controlled trial of the Books Beyond Words booklet for epilepsy .
METHODS	We will use a two-arm , single-centre randomized controlled feasibility design , over a 20-month period , across five epilepsy clinics in Hertfordshire , United Kingdom .
METHODS	We will recruit 40 eligible adults with learning disabilities and a confirmed diagnosis of epilepsy and will randomize them to use either the Books Beyond Words booklet plus usual care ( intervention group ) or to receive routine information and services ( control group ) .
METHODS	We will collect quantitative data about the number of eligible participants , number of recruited participants , demographic data , discontinuation rates , variability of the primary outcome measure ( quality of life : Epilepsy and Learning Disabilities Quality of Life scale ) , seizure severity , seizure control , intervention 's patterns of use , use of other epilepsy-related information , resource use and the EQ-5D-5L health questionnaire .
METHODS	We will also gather qualitative data about the feasibility and acceptability of the study procedures and the Books Beyond Words booklet .
METHODS	Ethical approval for this study was granted on 28 April 2014 , by the Wales Research Ethics Committee 5 .
METHODS	Recruitment began on 1 July 2014 .
CONCLUSIONS	The outcomes of this feasibility study will be used to inform the design and methodology of a definitive study , adequately powered to determine the impact of the Books Beyond Words intervention to improve the management of epilepsy in people with learning disabilities .
BACKGROUND	http://ISRCTN80067039 ( Date of ISRCTN assignation : 23 April 2014 ) .

###25972490
OBJECTIVE	To study the efficacy and safety of low-dose oral tetrahydrocannabinol ( THC ) in the treatment of dementia-related neuropsychiatric symptoms ( NPS ) .
METHODS	This is a randomized , double-blind , placebo-controlled study .
METHODS	Patients with dementia and clinically relevant NPS were randomly assigned to receive THC 1.5 mg or matched placebo ( 1:1 ) 3 times daily for 3 weeks .
METHODS	Primary outcome was change in Neuropsychiatric Inventory ( NPI ) , assessed at baseline and after 14 and 21 days .
METHODS	Analyses were based on intention-to-treat .
RESULTS	Twenty-four patients received THC and 26 received placebo .
RESULTS	NPS were reduced during both treatment conditions .
RESULTS	The difference in reduction from baseline between THC and placebo was not significant ( mean difference NPItotal : 3.2 , 95 % confidence interval [ CI ] -3.6 to 10.0 ) , nor were changes in scores for agitation ( Cohen-Mansfield Agitation Inventory 4.6 , 95 % CI -3.0 to 12.2 ) , quality of life ( Quality of Life-Alzheimer 's Disease -0.5 , 95 % CI -2.6 to 1.6 ) , or activities of daily living ( Barthel Index 0.6 , 95 % CI -0.8 to 1.9 ) .
RESULTS	The number of patients experiencing mild or moderate adverse events was similar ( THC , n = 16 ; placebo , n = 14 , p = 0.36 ) .
RESULTS	No effects on vital signs , weight , or episodic memory were observed .
CONCLUSIONS	Oral THC of 4.5 mg daily showed no benefit in NPS , but was well-tolerated , which adds valuable knowledge to the scarce evidence on THC in dementia .
CONCLUSIONS	The benign adverse event profile of this dosage allows study of whether higher doses are efficacious and equally well-tolerated .
METHODS	This study provides Class I evidence that for patients with dementia-related NPS , low-dose THC does not significantly reduce NPS at 21 days , though it is well-tolerated .

###24994573
OBJECTIVE	This study aimed to investigate the effects of an interpersonal-psychotherapy-oriented postnatal psychoeducation programme on postpartum depressive symptoms , social support and maternal role competence in Chinese first-time mothers .
METHODS	A randomized , controlled trial was conducted in the postnatal unit of a regional hospital in China .
METHODS	The intervention consisted of a 1-h education session before discharge and one telephone follow-up within the 2 weeks after discharge from the hospital .
METHODS	One hundred and eighty first-time Chinese mothers were randomly assigned to the study group ( n = 90 ) or the control group ( n = 90 ) .
METHODS	Outcomes of the study included symptoms of postpartum depression , social support and maternal role competence which were measured by the Edinburgh Postnatal Depression Scale , the Perceived Social Support Scale and the Parenting Sense of Competence Scale-Efficacy subscale , respectively .
RESULTS	Women receiving the postnatal psychoeducation programme had significantly fewer depressive symptoms ( Mean [ SD ] = 7.61 [ 3.43 ] versus 8.96 [ 4.55 ] ; t = -2.24 ; p = 0.026 ) , higher level of social support ( Mean [ SD ] = 65.44 [ 8.43 ] versus 61.82 [ 9.99 ] ; t = 2.63 ; p = 0.009 ) and better maternal role competence ( Mean [ SD ] = 35.87 [ 4.41 ] versus 32.79 [ 6.86 ] ; t = 3.59 ; p < 0.001 ) at 6 weeks postpartum as compared with those who received routine postnatal care .
CONCLUSIONS	An interpersonal-psychotherapy-oriented postnatal psychoeducation programme may have the potential to facilitate the Chinese first-time mothers ' transition to motherhood .
CONCLUSIONS	A larger trial is needed to test for therapist effects , a full economic evaluation , and whether the intervention is acceptable to staff and feasible to use in current practice .

###24559855
OBJECTIVE	Reduced epidermal ceramide content may lead to an impaired skin barrier in atopic dermatitis .
OBJECTIVE	Plasma concentration of the ceramide precursor sphingomyelin increases after milk-fat consumption due to affected lipoprotein metabolism , although sphingomyelin , a main component of milk phospholipids , might also directly influence plasma sphingomyelin levels .
OBJECTIVE	The aim was to determine whether supplementation of a dairy drink with milk phospholipids improves skin parameters and influences plasma lipid profile .
METHODS	In a double-blind cross-over study , 39 patients were randomized into 2 groups and daily received phospholipid milk ( 3g phospholipids 0.75 g sphingomyelin ) or normal whole milk as placebo control for 6 weeks .
METHODS	SCORAD indices , serum immune and plasma lipid parameters were determined .
RESULTS	SCORAD indices did not differ between groups following control and phospholipid milk supplementation ( control milk : 10.95.9 vs. phospholipid milk : 11.76.9 , P = 0.416 ) , but were significantly decreased compared to baseline ( baseline : 15.68.8 , P < 0.05 ) .
RESULTS	Plasma sphingomyelin proportions were also similar after the treatments ( control milk : 27.52.3 vs. phospholipid milk : 27.42.6 % of total phospholipids , P = 0.894 ) , but were significantly increased compared to baseline ( 20.72.4 % of total phospholipids , P < 0.05 ) .
CONCLUSIONS	Supplementation of a dairy drink with milk phospholipids has no beneficial effect on skin parameters compared to consumption of whole milk in patients with atopic dermatitis .
CONCLUSIONS	To elucidate an impact of the plasma sphingomyelin proportion on skin conditions , further studies are necessary .
CONCLUSIONS	Clinical trial ID : Registered under ClinicalTrials.gov .
CONCLUSIONS	Identifier no .
CONCLUSIONS	NCT01326520 .

###25190154
OBJECTIVE	Our study examined the effect of a ChinaYuan ( CNY ) 10 cash incentive on the participation rate in a face-to-face health survey among the general Chinese population .
METHODS	Subjects older than 15 years of age and had been living in the two selected districts for more than 6 months were selected using multistage random sampling .
METHODS	Participants from only one district received a cash incentive ( CNY 10 ) for completing the survey .
RESULTS	The participation rates in the nonincentive and incentive groups were 39.9 % and 61.2 % , respectively , P < 0.01 .
RESULTS	In the nonincentive group , the 65-74 years age group had the highest participation rate ( 54.4 % ) ; no significant difference was found between men ( 39.4 % ) and women ( 40.5 % ) , P = 0.59 .
RESULTS	In the incentive group , the highest participation rate was observed in the 75 years ( 78.1 % ) age group .
RESULTS	The cost for a completed interview was CNY 34.5 in the incentive group and CNY 35.8 in the nonincentive group .
CONCLUSIONS	Cash incentives might increase participation rates in face-to-face surveys in China .
CONCLUSIONS	The absolute cost was higher for the incentive group , whereas cost for a completed interview was actually the lowest .
CONCLUSIONS	Furthermore , participation rate did not differ between men and women , but elders were more likely to participate in health surveys .

###24975273
METHODS	Vitamin D , its biologically most active metabolite 1,25-dihydroxyvitamin D ( 1,25 ( OH ) D ) , and the vitamin D receptor ( VDR ) are important for adipose tissue biology .
RESULTS	We extrapolated genomic VDR association loci in adipocytes from 55 conserved genome-wide VDR-binding sites in nonfat tissues .
RESULTS	Taking the genes DUSP10 , TRAK1 , NRIP1 , and THBD as examples , we confirmed the predicted VDR binding sites upstream of their transcription start sites and showed rapid mRNA up-regulation of all four genes in SGBS human pre-adipocytes .
RESULTS	Using adipose tissue biopsy samples from 47 participants of a 5-month vitamin D intervention study , we demonstrated that all four primary VDR target genes can serve as biomarkers for the vitamin D responsiveness of human individuals .
RESULTS	Changes in DUSP10 gene expression appear to be the most comprehensive marker , while THBD mRNA changes characterized a rather different group of study participants .
CONCLUSIONS	We present a new approach to predict vitamin D target genes based on conserved genomic VDR-binding sites .
CONCLUSIONS	Using human adipocytes as examples , we show that such ubiquitous VDR target genes can be used as markers for the individual 's response to a supplementation with vitamin D.

###24712716
OBJECTIVE	To examine the relationship between premature ejaculation and plasma melatonin levels , and assess the efficacy of selective serotonin reuptake inhibitors in treating premature ejaculation .
METHODS	A total of 60 men with lifelong premature ejaculation and 40 healthy male controls were included in the present study .
METHODS	For each participant , a medical history was obtained , a physical examination was carried out , and intravaginal ejaculation latency time and melatonin levels were measured .
METHODS	Premature ejaculation patients were randomly categorized into three treatment groups : group1 received fluoxetine ( 20mg/day ) , group2 received paroxetine ( 20mg/day ) and group3 received sertraline ( 50mg/day ) .
RESULTS	The mean baseline plasma melatonin levels in men with premature ejaculation were significantly lower than in the healthy controls ( 5.34 vs 14.84 pg/mL ) .
RESULTS	After 4weeks of treatment , the mean intravaginal ejaculation latency time scores for all of the premature ejaculation treatment groups showed a significant improvement from the baseline values .
RESULTS	The plasma melatonin levels were also significantly increased ( P < 0.05 ) from baseline ( 5.34 pg/mL ) to 9.50 pg/mL , 10.24 pg/mL or 13.30 pg/mL for groups1 , 2 and 3 , respectively .
CONCLUSIONS	Our findings show that premature ejaculation is associated with decreased plasma melatonin levels .
CONCLUSIONS	After treatment with selective serotonin reuptake inhibitors , an increased plasma melatonin level can retard ejaculation , presumably by both central and peripheral mechanisms .
CONCLUSIONS	This is the first study to evaluate the possible role of serotoninergic interactions on the melatoninergic system in premature ejaculation .

###24657830
OBJECTIVE	To develop a whole joint scoring system , the Anterior Cruciate Ligament OsteoArthritis Score ( ACLOAS ) , for magnetic resonance imaging ( MRI ) - based assessment of acute anterior cruciate ligament ( ACL ) injury and follow-up of structural sequelae , and to assess its reliability .
METHODS	Baseline and follow-up 1.5 T MRI examinations from 20 patients of the KANON study , a randomized controlled study comparing a surgical and non-surgical treatment strategy , were assessed for up to six longitudinal visits using a novel MRI scoring system incorporating acute structural tissue damage and longitudinal changes including osteoarthritis ( OA ) features .
METHODS	Joint features assessed were acute osteochondral injury , traumatic and degenerative bone marrow lesions ( BMLs ) , meniscus morphology and extrusion , osteophytes , collateral and cruciate ligaments including ACL graft , Hoffa-synovitis and effusion-synovitis .
METHODS	Cross-sectional ( baseline ) and longitudinal ( all time points and change ) intra - and inter-observer reliability was calculated using weighted ( w ) kappa statistics and overall percent agreement on a compartmental basis ( medial tibio-femoral , lateral tibio-femoral , patello-femoral ) .
RESULTS	Altogether 87 time points were evaluated .
RESULTS	Intra-observer reliability ranged between 0.52 ( baseline , Hoffa-synovitis ) and 1.00 ( several features ) , percent agreement between 52 % ( all time points , Hoffa-synovitis ) and 100 % ( several features ) .
RESULTS	Inter-observer reliability ranged between 0.00 and 1.00 , which is explained by low frequency of some of the features .
RESULTS	Altogether , 73 % of all assessed 142 parameters showed w-kappa values between 0.80 and 1.00 and 92 % showed agreement above 80 % .
CONCLUSIONS	ACLOAS allows reliable scoring of acute ACL injury and longitudinal changes .
CONCLUSIONS	This novel scoring system incorporates features that may be relevant for structural outcome not covered by established OA scoring instruments .

###25280804
BACKGROUND	Gliomas are among the biggest challenges in neurological and oncology rehabilitation and optimising treatment is of major clinical importance in this population .
BACKGROUND	Although inpatient rehabilitation among glioma patients ' results in improved functional measures , rehabilitation efforts are still not emphasised in this patient group and the literature lacks studies investigating the impact of outpatient rehabilitation .
METHODS	This protocol describes a randomised 6-week parallel group rehabilitation study investigating an outpatient interdisciplinary rehabilitation programme .
METHODS	The intervention consists of 6weeks intensive physiotherapy as groups exercise in conjunction with 0-6weeks of individual occupational therapy if a need is present .
METHODS	The aim of this study is to describe the design of the upcoming randomised control trial ( RCT ) .
METHODS	The results of the RCT will add to the growing body of literature investigating the potential role of exercise as a supportive therapeutic intervention for a patient with cancer .
BACKGROUND	The project is approved by the Regional Scientific Ethical Committees for Southern Denmark under Project-ID : ( S-20140108 ) and by the Danish Data Protection Agency ( J. no.2008-58-0035 ) .
BACKGROUND	Dissemination will occur through presentation and findings will be published in peer-reviewed journals .
BACKGROUND	The key strength of this study is its randomised design and it is the first study to investigate a standardised outpatient interdisciplinary rehabilitation programme among patients with glioma .
BACKGROUND	A potential limitation is the uncertainty and risk of side effects to the concomitant treatment , which enhances the risk of dropout .
BACKGROUND	ClinicalTrials.gov Identifier NCT02221986 .

###25461496
BACKGROUND	The positive effects of weight loss on obesity-related risk factors diminish unless weight loss is maintained .
BACKGROUND	Yet little work has focused on the translation of evidence-based weight loss interventions with the aim of sustaining weight loss in underserved populations .
BACKGROUND	Using a community-based participatory approach ( CBPR ) that engages the strong faith-based social infrastructure characteristic of rural African American communities is a promising way to sustain weight loss in African Americans , who bear a disproportionate burden of the obesity epidemic .
OBJECTIVE	Led by a collaborative community-academic partnership , The WORD aims to change dietary and physical activity behaviors to produce and maintain weight loss in rural , African American adults of faith .
METHODS	The WORD is a randomized controlled trial with 450 participants nested within 30 churches .
METHODS	All churches will receive a 16-session core weight loss intervention .
METHODS	Half of the churches will be randomized to receive an additional 12-session maintenance component .
METHODS	The WORD is a cultural adaptation of the Diabetes Prevention Program , whereby small groups will be led by trained church members .
METHODS	Participants will be assessed at baseline , 6 , 12 , and 18 months .
METHODS	A detailed cost-effectiveness and process evaluation will be included .
CONCLUSIONS	The WORD aims to sustain weight loss in rural African Americans .
CONCLUSIONS	The utilization of a CBPR approach and the engagement of the faith-based social infrastructure of African American communities will maximize the intervention 's sustainability .
CONCLUSIONS	Unique aspects of this trial include the focus on weight loss maintenance and the use of a faith-based CBPR approach in translating evidence-based obesity interventions .

###25522347
OBJECTIVE	Rates of weight-based stigmatization have steadily increased over the past decade .
OBJECTIVE	The psychological and physiological consequences of weight stigma remain understudied .
METHODS	This study examined the effects of experimentally manipulated weight stigma on the stress-responsive hypothalamic-pituitary-adrenal axis ( HPA ) in 110 female undergraduate participants ( BMI : M = 19.30 , SD = 1.55 ) .
METHODS	Objective BMI and self-perceived body weight were examined as moderators of the relationship between stigma and HPA reactivity .
RESULTS	Results indicated participants ' perceptions of their own body weight ( but not objective BMI ) moderated the effect of weight stigma on cortisol reactivity : F ( 1,102 ) = 13.48 , P < 0.001 , ( 2 ) p = 0.12 ( interaction 95 % CI range [ -2.06 to -1.44 , -1.31 to -0.99 ] ) .
RESULTS	Specifically , participants who perceived themselves as heavy exhibited sustained cortisol elevation post-manipulation compared with individuals who did not experience the weight-related stigma .
RESULTS	Cortisol change did not vary by condition for participants who perceived themselves as average weight .
CONCLUSIONS	In the first study to examine physiological consequences of active interpersonal exposure to weight stigma , experiencing weight stigma was stressful for participants who perceived themselves as heavy , regardless of their BMI .
CONCLUSIONS	These results are important because stress and cortisol are linked to deleterious health outcomes , stimulate eating , and contribute to abdominal adiposity .

###24298779
OBJECTIVE	To observe the effectiveness and safety of electroacupuncture ( EA ) at Neimadian ( Extra ) and Neiguan ( PC 6 ) for analgesia after thoracic surgery .
METHODS	One hundred and twenty cases of thoracic surgery were randomly divided into an electroacupuncture ( EA ) group ( 60 cases ) and a medication group ( 60 cases ) .
METHODS	EA was applied at Neimadian ( Extra ) and Neiguan ( PC 6 ) for postoperation analgesia in the EA group , while patient-controlled intravenous analgesia ( PCIA ) was applied in the medication group .
METHODS	The score of visual analogue scale ( VAS ) , analgesia effect , safety and beta-endorphin level after the treatment in both groups were compared .
RESULTS	Compared with those before the treatment , the VAS scores in every time point after surgery were decreased ( all P < 0.05 ) , which were lower in the EA group ( P < 0.01 ) .
RESULTS	The excellent and good rates were 96.7 % ( 58/60 ) and 75.0 % ( 45/60 ) seperately , the analgesia effect in the EA group ( 2 h after operation ) was superior to that in the medication group ( P < 0.01 ) .
RESULTS	The safety degree in EA group was higher to that in the medication group ( P < 0.01 ) .
RESULTS	Compared with that before the treatment , the beta-endorphin level in two groups after treatment was both increased , which was higher in the EA group ( P < 0.01 ) .
CONCLUSIONS	Electroacupuncture at Neimadian ( Extra ) and Neiguan ( PC 6 ) has better analgesia effect ( 2 h after operation ) and safety than PICA on analgesia after thoracic surgery .

###24862763
OBJECTIVE	To evaluate the short-term effect on spinal mobility , pain perception , neural mechanosensitivity , and full height recovery after high-velocity , low-amplitude ( HVLA ) spinal manipulation ( SM ) in the lumbosacral joint ( L5-S1 ) .
METHODS	Randomized , double-blind , controlled clinical trial with evaluations at baseline and after intervention .
METHODS	University-based physical therapy research clinic .
METHODS	Men ( N = 40 ; mean age SD , 38 9.14 y ) with diagnosed degenerative lumbar disease at L5-S1 were randomly divided into 2 groups : a treatment group ( TG ) ( n = 20 ; mean age SD , 39 9.12 y ) and a control group ( CG ) ( n = 20 ; mean age SD , 37 9.31 y ) .
METHODS	All participants completed the intervention and follow-up evaluations .
METHODS	A single L5-S1 SM technique ( pull-move ) was performed in the TG , whereas the CG received a single placebo intervention .
METHODS	Measures included assessing the subject 's height using a stadiometer .
METHODS	The secondary outcome measures included perceived low back pain , evaluated using a visual analog scale ; neural mechanosensitivity , as assessed using the passive straight-leg raise ( SLR ) test ; and amount of spinal mobility in flexion , as measured using the finger-to-floor distance ( FFD ) test .
RESULTS	The intragroup comparison indicated a significant improvement in all variables in the TG ( P < .001 ) .
RESULTS	There were no changes in the CG , except for the FFD test ( P = .008 ) .
RESULTS	In the between-group comparison of the mean differences from pre - to postintervention , there was statistical significance for all cases ( P < .001 ) .
CONCLUSIONS	An HVLA SM in the lumbosacral joint performed on men with degenerative disk disease immediately improves self-perceived pain , spinal mobility in flexion , hip flexion during the passive SLR test , and subjects ' full height .
CONCLUSIONS	Future studies should include women and should evaluate the long-term results .

###24485109
OBJECTIVE	To compare the clinical efficacy of warmed irrigation fluid and room-temperature fluid in decreasing perioperative hypothermia during arthroscopic rotator cuff surgery .
METHODS	In this prospective , randomized , comparative study , warmed ( 36C ) arthroscopic irrigation fluid ( group W , n = 36 ) or room-temperature irrigation fluid ( group RT , n = 36 ) was used without intraoperative warming devices during arthroscopic shoulder surgery in 72 patients .
METHODS	The serial core body temperature and the last and lowest core body temperatures were measured by use of an esophageal stethoscope with a thermometer and a digital tympanic thermometer at 15-minute intervals during the operation and recovery period , respectively .
METHODS	When patients arrived in the postanesthesia care unit ( PACU ) after surgery , they were warmed immediately and monitored thereafter for body temperature and development of hypothermia-related adverse effects such as postoperative shivering and cardiac events .
METHODS	We evaluated the changes in the patients ' weight and prothrombin time on postoperative day 1 and the hemoglobin level and visual analog scale pain score immediately after the operation and on postoperative day 1 .
RESULTS	The 2 groups did not differ in demographic and surgical data and incidence of intraoperative hypothermia ( 33 of 36 [ 91.6 % ] in group RT and 34 of 36 [ 94.4 % ] in group W , P = .276 ) .
RESULTS	The core body temperatures decreased throughout the surgery and increased linearly in the PACU , without any intergroup differences ( P > .05 ) .
RESULTS	All patients were normothermic within 1 hour of arrival in the PACU .
RESULTS	The 2 groups did not differ in postoperative weight change , prothrombin time , hemoglobin level , or postoperative visual analog scale pain score ( all P > .05 ) .
RESULTS	Postoperative shivering occurred in 3 patients and 1 patient in group RT and group W , respectively .
RESULTS	No cardiac events occurred in either group .
CONCLUSIONS	Warmed irrigation fluid was not superior to room-temperature irrigation fluid in reducing the occurrence of perioperative hypothermia during arthroscopic shoulder surgery .
METHODS	Level I , randomized controlled trial .

###25975013
BACKGROUND	Sweat testing in young infants ( 3 months ) with a positive newborn screen for Cystic Fibrosis ( CF ) can yield higher rates of inadequate sweat collection .
BACKGROUND	The role of salt supplements in improving sweat collection has not been studied before .
METHODS	All young infants referred to our CF center for sweat testing were randomized to either receive salt supplements { 1/8th teaspoon salt ( 750 mg ) } mixed in formula feeds 1 day prior to sweat testing ( study group ) or no salt supplement ( controls ) .
RESULTS	Of the 151 young infants that underwent sweat testing over 18 months , 75 received salt supplements , while 76 did not .
RESULTS	A total of 9 ( 11.8 % ) infants in the salt supplement group had inadequate sweat collection , as compared to 4 ( 5.2 % ) infants in the control group ( p = 0.16 , Fisher 's Exact Test ) .
CONCLUSIONS	Oral salt supplementation for young infants prior to sweat testing does not help to reduce the rates of inadequate sweat collection .

###25139338
OBJECTIVE	Although the relationship between smoking and prostate cancer risk is inconsistent , some studies show that smoking is associated with prostate cancer mortality .
OBJECTIVE	Whether this reflects delayed diagnosis or direct smoking-related effects is unknown .
OBJECTIVE	REDUCE , which followed biopsy-negative men with protocol-dictated prostate-specific antigen ( PSA ) - independent biopsies at 2 and 4 years , provides an opportunity to evaluate smoking and prostate cancer diagnosis with minimal confounding from screening biases .
METHODS	Logistic regression was conducted to test the association between smoking and cancer on the first on-study biopsy ( no cancer , low-grade Gleason 4-6 , high-grade Gleason 7-10 ) in REDUCE .
RESULTS	Of 6,240 men with complete data and 1 on-study biopsy , 2,937 ( 45.8 % ) never smoked , 929 ( 14.5 % ) were current smokers , and 2,554 ( 39.8 % ) were former smokers .
RESULTS	Among men with negative first on-study biopsies , smokers were 36 % less likely to receive a second on-study biopsy ( P < 0.001 ) .
RESULTS	At first on-study biopsy , 941 ( 14.7 % ) men had cancer .
RESULTS	Both current and former smoking were not significantly associated with either total or low-grade prostate cancer ( all P > 0.36 ) .
RESULTS	Current ( OR = 1.44 , P = 0.028 ) but not former smokers ( OR = 1.21 , P = 0.12 ) were at increased risk of high-grade disease .
RESULTS	On secondary analysis , there was an interaction between smoking and body mass index ( BMI ; Pinteraction = 0.017 ) : current smokers with BMI 25 kg/m ( 2 ) had an increased risk of low-grade ( OR = 1.54 , P = 0.043 ) and high-grade disease ( OR = 2.45 , P = 0.002 ) , with null associations for BMI 25 kg/m ( 2 ) .
CONCLUSIONS	Among men with elevated PSA and negative pre-study biopsy in REDUCE , in which biopsies were largely PSA independent , smoking was unrelated to overall prostate cancer diagnosis but was associated with increased risk of high-grade prostate cancer .

###25463825
BACKGROUND	Down syndrome is a frequent cause of intellectual disability , with severe impact on the quality of life of affected individuals and their families , and high social costs .
BACKGROUND	Intervention programs should start soon after birth but no consensus exists on specific types and timing of early interventions in this population .
OBJECTIVE	This pilot study explores the effects of an early multi-sensory intervention , based on body massage , on the development of visual function in infants with Down syndrome .
METHODS	Infants were randomly allocated to either a massage or a control group .
METHODS	Intervention consisted of only standard care ( Control Group ) or standard care plus infant massage ( Massaged Group ) .
METHODS	Visual acuity was assessed by Teller Acuity Cards and stereopsis by the Frisby Stereopsis Screening Test at 5 , 6 , 9 and 12 months .
RESULTS	Massaged Group Infants showed a significantly higher visual acuity at 6 months of age and an accelerated development up to at least 12 months ; compared to Controls , stereopsis had an earlier onset in the Massaged Group followed by a faster maturation .
CONCLUSIONS	Environmental enrichment , in the tested form of infant massage , seems to affect maturation of visual functions in human infants , also in the presence of a genetic disability , when applied during a period of high brain plasticity .

###24314839
OBJECTIVE	To describe risk factors for scar in eyes treated with ranibizumab or bevacizumab for neovascular age-related macular degeneration ( AMD ) .
METHODS	Prospective cohort study within a randomized clinical trial .
METHODS	Patients with no scar on color fundus photography ( CFP ) or fluorescein angiography ( FA ) at enrollment in the Comparison of Age-related Macular Degeneration Treatments Trials ( CATT ) .
METHODS	Eyes were assigned to ranibizumab or bevacizumab treatment and to 1 of 3 dosing regimens for 2 years .
METHODS	Masked readers assessed CFP and FA .
METHODS	Baseline demographic characteristics , visual acuity , morphologic features on photography and optical coherence tomography ( OCT ) , and genotypes associated with AMD risk were evaluated as risk factors using adjusted hazard ratios ( aHRs ) and associated 95 % confidence intervals ( CIs ) .
METHODS	Scars were classified as fibrotic with well-demarcated elevated mounds of yellowish whitetissue or nonfibrotic with discrete flat areas of hyperpigmentation with varying amounts of central depigmentation .
METHODS	Scar formation .
RESULTS	Scar developed in 480 of 1059 eyes ( 45.3 % ) by 2 years .
RESULTS	Baseline characteristics associated with greater risk of scarring were predominantly classic choroidal neovascularization ( CNV ) ( aHR , 3.1 ; CI , 2.4-3 .9 ) versus occult CNV , blocked fluorescence ( aHR , 1.4 ; CI , 1.1-1 .8 ) , foveal retinal thickness > 212 m ( aHR , 2.4 ; CI , 1.7-3 .6 ) versus < 120 m , foveal subretinal tissue complex thickness > 275 m ( aHR , 2.4 ; CI , 1.7-3 .6 ) versus 75 m , foveal subretinal fluid ( aHR , 1.5 ; CI , 1.1-2 .0 ) versus no subretinal fluid , and subretinal hyperreflective material ( SHRM ) ( aHR , 1.7 ; CI , 1.3-2 .3 ) versus no SHRM .
RESULTS	Eyes with elevation of the retinal pigment epithelium had lower risk ( aHR , 0.6 ; CI , 0.5-0 .8 ) versus no elevation .
RESULTS	Drug , dosing regimen , and genotype had no statistically significant association with scarring .
RESULTS	Fibrotic scars developed in 24.7 % of eyes , and nonfibrotic scars developed in 20.6 % of eyes .
RESULTS	Baseline risk factors for the scar types were similar except that eyes with larger lesion size or visual acuity < 20/40 were more likely to develop fibrotic scars .
CONCLUSIONS	Approximately half of eyes enrolled in CATT developed scar by 2 years .
CONCLUSIONS	Eyes with classic neovascularization , a thicker retina , and more fluid or material under the foveal center of the retina are more likely to develop scar .

###24902007
OBJECTIVE	Post hoc analyses were conducted to evaluate the efficacy of levomilnacipran extended-release ( ER ) in subgroups of patients with major depressive disorder ( MDD ) .
METHODS	Data were pooled from 5 completed Phase II/III studies .
METHODS	Patients were categorized by sex , age , MDD duration , recurrence of MDD , current episode duration , number of prior episodes , and baseline Montgomery-sberg Depression Rating Scale ( MADRS ) score .
METHODS	Efficacy was evaluated by MADRS least squares ( LS ) mean change from baseline , response ( MADRS improvement 50 % ) , and remission ( MADRS 10 ) .
RESULTS	In the pooled population , treatment with levomilnacipran ER versus placebo resulted in greater improvement in MADRS score ( -15.8 versus -12.9 ; LS mean difference , -2.9 ; P < .001 ) and higher response rates ( 44.7 % versus 34.5 % ; P < .001 ) .
RESULTS	Comparable treatment effects were found in most subgroups .
RESULTS	Remission rates in the overall population were higher for levomilnacipran ER versus placebo ( 27.7 % versus 21.5 % ; P < .05 ) ; notably high remission rates were seen in patients with baseline MADRS score < 30 ( 48.8 % versus 28.9 % ; P < .001 ) .
RESULTS	Discussion Clinically meaningful improvements in depressive symptoms were found across subgroups , including statistically significant outcomes for both response and remission .
CONCLUSIONS	Levomilnacipran ER was efficacious across a wide range of MDD patients , including men and women , ages 18-78 , with varying histories and symptom severity .

###24552831
BACKGROUND	During long-term anticoagulation in atrial fibrillation , temporary interruptions ( TIs ) of therapy are common , but the relationship between patient outcomes and TIs has not been well studied .
BACKGROUND	We sought to determine reasons for TI , the characteristics of patients undergoing TI , and the relationship between anticoagulant and outcomes among patients with TI .
RESULTS	In the Rivaroxaban Once Daily , Oral , Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation ( ROCKET AF ) , a randomized , double-blind , double-dummy study of rivaroxaban and warfarin in nonvalvular atrial fibrillation , baseline characteristics , management , and outcomes , including stroke , non-central nervous system systemic embolism , death , myocardial infarction , and bleeding , were reported in participants who experienced TI ( 3-30 days ) for any reason .
RESULTS	The at-risk period for outcomes associated with TI was from TI start to 30 days after resumption of study drug .
RESULTS	In 14 236 participants who received at least 1 dose of study drug , 4692 ( 33 % ) experienced TI .
RESULTS	Participants with TI were similar to the overall ROCKET AF population in regard to baseline clinical characteristics .
RESULTS	Only 6 % ( n = 483 ) of TI incidences involved bridging therapy .
RESULTS	Stroke/systemic embolism rates during the at-risk period were similar in rivaroxaban-treated and warfarin-treated participants ( 0.30 % versus 0.41 % per 30 days ; hazard ratio [ confidence interval ] = 0.74 [ 0.36-1 .50 ] ; P = 0.40 ) .
RESULTS	Risk of major bleeding during the at-risk period was also similar in rivaroxaban-treated and warfarin-treated participants ( 0.99 % versus 0.79 % per 30 days ; hazard ratio [ confidence interval ] = 1.26 [ 0.80-2 .00 ] ; P = 0.32 ) .
CONCLUSIONS	TI of oral anticoagulation is common and is associated with substantial stroke risks and bleeding risks that were similar among patients treated with rivaroxaban or warfarin .
CONCLUSIONS	Further investigation is needed to determine the optimal management strategy in patients with atrial fibrillation requiring TI of anticoagulation .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00403767 .

###24622000
OBJECTIVE	The purpose of this study was to characterize the relationship between heart rate and post-discharge outcomes in patients with hospitalization for heart failure ( HHF ) with reduced ejection fraction ( EF ) in sinus rhythm .
BACKGROUND	A reduction in heart rate improves clinical outcomes in patients with chronic heart failure and in sinus rhythm , but the association between heart rate and post-discharge outcomes in patients with HHF is presently unclear .
METHODS	This post-hoc analysis of the EVEREST ( Efficacy of Vasopressin Antagonism in Heart Failure : Outcome Study With Tolvaptan ) trial examined 1,947 patients with HHF and EF40 % not in atrial fibrillation/flutter or pacemaker dependent .
RESULTS	The median follow-up period was 9.9 months .
RESULTS	At baseline , patients with a higher heart rate tended to be younger with lower EF and were more likely to have worse New York Heart Association functional class and higher natriuretic peptide levels .
RESULTS	After adjustment for clinical risk factors , baseline heart rate was not predictive of all-cause mortality ( p 0.066 ) .
RESULTS	However , at70 beats/min , every 5-beat increase in 1-week post-discharge heart rate was independently associated with increased all-cause mortality ( hazard ratio : 1.13 [ 95 % confidence interval : 1.05 to 1.22 ] ; p = 0.002 ) .
RESULTS	Similarly , every 5-beat increase70 beats/min in 4-week post-discharge heart rate was predictive of all-cause mortality ( hazard ratio : 1.12 [ 95 % confidence interval : 1.05 to 1.19 ] ; p = 0.001 ) .
CONCLUSIONS	In this large cohort of patients with HHF with reduced EF and in sinus rhythm , baseline heart rate did not correlate with all-cause mortality .
CONCLUSIONS	In contrast , at70 beats/min , higher heart rate in the early post-discharge period was independently predictive of death during subsequent follow-up .
CONCLUSIONS	Further study of post-discharge heart rate as a potential therapeutic target in this high-risk population is encouraged .

###25977992
BACKGROUND	Epidural infusion of levobupivacaine and ropivacaine provides adequate postoperative pain management by minimizing side effects related to IV opioids and improving patient outcome .
BACKGROUND	The safety profile of different drugs can be better estimated by comparing their pharmacokinetic profiles than by considering their objective side effects .
BACKGROUND	Because levobupivacaine and ropivacaine have different pharmacokinetic properties , our aim was to investigate whether there is a difference in the pharmacokinetic variability of the 2 drugs in a homogeneous population undergoing continuous epidural infusion .
BACKGROUND	This double-blind , multicenter , randomized , controlled trial study was designed to compare the pharmacokinetics of continuous thoracic epidural infusion of levobupivacaine 0.125 % or ropivacaine 0.2 % for postoperative pain management in adult patients who had undergone major abdominal , urological , or gynecological surgery .
BACKGROUND	This study is focused on the evaluation of the coefficient of variation ( CV ) to assess the equivalence in the systemic exposure and interindividual variability between levobupivacaine and ropivacaine and , therefore , the possible differences in the predictability of the plasmatic concentrations of the 2 drugs during thoracic epidural infusion .
METHODS	One hundred eighty-one adults undergoing major abdominal surgery were enrolled in the study .
METHODS	Patients were randomized to receive an epidural infusion of levobupivacaine 0.125 % + sufentanil 0.75 g/mL or of ropivacaine 0.2 % + sufentanil 0.75 g/mL at 5 mL/h for 48 hours .
METHODS	The primary end point of this study was to analyze the variability of plasma concentration of levobupivacaine and ropivacaine via an area under the curve within a range of 15 % of the CV during 48 hours of continuous epidural infusion .
METHODS	The CV shows how the concentration values of local anesthetics are scattered around the median concentration value , thus indicating the extent to which plasma concentration is predictable during infusion .
METHODS	Secondary end points were to assess the pharmacologic profile of the local anesthetics used in the study , including an analysis of mean peak plasma concentrations , and also to assess plasma clearance , side effects , pain intensity ( measured with a verbal numeric ranging score , i.e. , static Numeric Rating Scale [ NRS ] and dynamic NRS ] ) , and the need for rescue doses .
RESULTS	The comparison between the 2 CVs showed no statistical difference : the difference between area under the curve was within the range of 15 % .
RESULTS	The CV was 0.54 for levobupivacaine and 0.51 for ropivacaine ( P = 0.725 ) .
RESULTS	The plasma concentrations of ropivacaine approached the Cmax significantly faster than those of levobupivacaine .
RESULTS	Clearance of ropivacaine decreases with increasing patient age .
RESULTS	There were no significant differences in NRS , dynamic NRS scores , the number of rescue doses , or in side effects between groups .
CONCLUSIONS	Considering the CV , the interindividual variability of plasma concentration for levobupivacaine and ropivacaine is equivalent after thoracic epidural infusion in adults .
CONCLUSIONS	We found a reduction in clearance of ropivacaine depending on patient age , but this finding could be the result of some limitations of our study .
CONCLUSIONS	The steady-state concentration was not reached during the 48-hour infusion and the behavior of plasma concentrations of ropivacaine and levobupivacaine during continuous infusions lasting more than 48 hours remains to be investigated , because they could reach toxic levels .
CONCLUSIONS	Finally , no differences in the clinical efficacy or in the incidence of adverse effects between groups were found for either local anesthetic .

###25882919
OBJECTIVE	The risk of urinary tract infection ( UTI ) among women undergoing elective gynecological surgery during which a catheter is placed is high : 10-64 % following catheter removal .
OBJECTIVE	We conducted the first randomized , double-blind , placebo-controlled trial of the therapeutic efficacy of cranberry juice capsules in preventing UTI after surgery .
METHODS	We recruited patients from a single hospital between August 2011 and January 2013 .
METHODS	Eligible participants were undergoing elective gynecological surgery that did not involve a fistula repair or vaginal mesh removal .
METHODS	One hundred sixty patients were randomized and received 2 cranberry juice capsules 2 times a day , equivalent to 2 8 ounce servings of cranberry juice , for 6 weeks after surgery or matching placebo .
METHODS	The primary endpoint was the proportion of participants who experienced clinically diagnosed and treated UTI with or without positive urine culture .
METHODS	Kaplan-Meier plots and log rank tests compared the 2 treatment groups .
RESULTS	The occurrence of UTI was significantly lower in the cranberry treatment group compared with the placebo group ( 15 of 80 [ 19 % ] vs 30 of 80 [ 38 % ] ; odds ratio , 0.38 ; 95 % confidence interval , 0.19-0 .79 ; P = .008 ) .
RESULTS	After adjustment for known confounders , including the frequency of intermittent self-catheterization in the postoperative period , the protective effects of cranberry remained ( odds ratio , 0.42 ; 95 % confidence interval , 0.18-0 .94 ) .
RESULTS	There were no treatment differences in the incidence of adverse events , including gastrointestinal upset ( 56 % vs 61 % for cranberry vs placebo ) .
CONCLUSIONS	Among women undergoing elective benign gynecological surgery involving urinary catheterization , the use of cranberry extract capsules during the postoperative period reduced the rate of UTI by half .

###24763888
OBJECTIVE	Just as hip prosthesis , most of the patients undergoing orthopedic lower extremity surgery ( OLES ) belong to the advanced age group .
OBJECTIVE	Sciatic nerve block combined with psoas compartment block is used as a technique alternative to central neuraxial block and GA. .
OBJECTIVE	In geriatric patients that will undergo partial hip prosthesis , the effects of the methods of unilateral spinal anesthesia ( SA ) and L1 paravertebral block combined with psoas compartment block ( PCB ) and sciatic nerve block ( PCSL ) on peroperative hemodynamic parameters and the duration of need for postoperative analgesia were studied .
METHODS	Fifty patients from the ASA III-IV group were randomly divided into two groups .
METHODS	Group SA was administered spinal anesthesia with hyperbaric bupivacaine ( 2 ml , 0.5 % ) from the selected intervertebral distance ( L4-L5 or L3-L4 ) in lateral position .
METHODS	Group PCSL was administered L1 paravertebral block combined with PCB and sciatic nerve block with bupivacaine hydrochloride ( total 35 ml ) .
METHODS	Hemodynamic parameters ( HR : heart rate and MAP : mean artery pressure ) were recorded in pre - and post-intervention 5-minute intervals .
METHODS	The initial time of the need for analgesia of patients were evaluated postoperatively .
RESULTS	Any failure in methods implemented on patients in either group was not observed .
RESULTS	Times of anesthesia and surgical preparation of patients were observed to have significantly prolonged in the PCSL compared to Group SA ( p < 0.005 ) .
RESULTS	Hundred and 5th and 110th min .
RESULTS	mean arterial pressures of patients was found to be significantly higher in Group SA compared to Group PCSL ( p < 0.05 ) .
RESULTS	The initial time of the need for analgesia was observed to be significantly prolonged in Group PCSL ( 432.80 236.77 min ) compared to Group SA ( 185.40 171.40 min ) ( p < 0.001 ) .
CONCLUSIONS	Unilateral SA conducted with bupivacaine hydrochloride and PCSL block technique provided a hemodynamically similar activity in the perioperative period in patients that underwent partial hip operation .
CONCLUSIONS	However , PCSL block implementation extended the initial time of the need for analgesia in postoperative period .
CONCLUSIONS	PCSL method could be selected in cases belonging to such group of patients .
CONCLUSIONS	PCSL block can be a alternative anesthetic tecniques in patients that underwent partial hip operation .

###25352655
OBJECTIVE	This study compared the efficacy and safety of dual add-on of saxagliptin plus dapagliflozin versus saxagliptin and dapagliflozin added on alone in patients with type 2 diabetes poorly controlled with metformin .
METHODS	This was a double-blind trial in adults with HbA1c 8.0 % and 12.0 % ( 64-108 mmol/mol ) , randomized to saxagliptin ( SAXA ) ( 5 mg/day ) plus dapagliflozin ( DAPA ) ( 10 mg/day ; n = 179 ) , or SAXA ( 5 mg/day ) and placebo ( n = 176 ) , or DAPA ( 10 mg/day ) and placebo ( n = 179 ) on background metformin extended release ( MET ) 1,500 mg/day .
METHODS	Primary objective compared changes from baseline in HbA1c with SAXA+DAPA+MET versus SAXA+MET and DAPA+MET .
RESULTS	Patients had a mean baseline HbA1c of 8.9 % ( 74 mmol/mol ) , diabetes duration of 7.6 years , and a BMI of 32 kg/m ( 2 ) .
RESULTS	At week 24 , the adjusted mean change from the baseline HbA1c was -1.5 % ( -16.1 mmol/mol ) with SAXA+DAPA+MET versus -0.9 % ( -9.6 mmol/mol ) with SAXA+MET ( difference -0.59 % [ -6.4 mmol/mol ] , P < 0.0001 ) and -1.2 % ( -13.1 mmol/mol ) with DAPA+MET ( difference -0.27 % [ 3.0 mmol/mol ] , P < 0.02 ) .
RESULTS	The proportion of patients achieving HbA1c < 7 % ( 53 mmol/mol ) was 41 % with SAXA+DAPA+MET versus 18 % with SAXA+MET and 22 % with DAPA+MET .
RESULTS	Urinary and genital infections occurred in 1 % of patients receiving SAXA+DAPA+MET .
RESULTS	Hypoglycemia was infrequent , with no episodes of major hypoglycemia .
CONCLUSIONS	In this first report of adding a well-tolerated combination of saxagliptin plus dapagliflozin to background metformin therapy in patients poorly controlled with metformin , greater improvements in glycemic control were obtained with triple therapy by the dual addition of saxagliptin and dapagliflozin than dual therapy with the addition of saxagliptin or dapagliflozin alone .

###24483160
BACKGROUND	A challenge for automated glycemic control in type 1 diabetes ( T1D ) is the large variation in insulin needs between individuals and within individuals at different times in their lives .
OBJECTIVE	The objectives of the study was to test the ability of a third-generation bihormonal bionic pancreas algorithm , initialized with only subject weight ; to adapt automatically to the different insulin needs of adults and adolescents ; and to evaluate the impact of optional , automatically adaptive meal-priming boluses .
METHODS	This was a randomized controlled trial .
METHODS	The study was conducted at an inpatient clinical research center .
METHODS	Twelve adults and 12 adolescents with T1D participated in the study .
METHODS	Subjects in each age group were randomized to automated glycemic control for 48 hours with or without automatically adaptive meal-priming boluses .
METHODS	Mean plasma glucose ( PG ) , time with PG less than 60 mg/dL , and insulin total daily dose were measured .
RESULTS	The 48-hour mean PG values with and without adaptive meal-priming boluses were 132 9 vs 146 9 mg/dL ( P = .03 ) in adults and 162 6 vs 175 9 mg/dL ( P = .01 ) in adolescents .
RESULTS	Adaptive meal-priming boluses improved mean PG without increasing time spent with PG less than 60 mg/dL : 1.4 % vs 2.3 % ( P = .6 ) in adults and 0.1 % vs 0.1 % ( P = 1.0 ) in adolescents .
RESULTS	Large increases in adaptive meal-priming boluses and shifts in the timing and size of automatic insulin doses occurred in adolescents .
RESULTS	Much less adaptation occurred in adults .
RESULTS	There was nearly a 4-fold variation in the total daily insulin dose across all cohorts ( 0.36-1 .41 U/kg d ) .
CONCLUSIONS	A single control algorithm , initialized only with subject weight , can quickly adapt to regulate glycemia in patients with TID and highly variable insulin requirements .

###25273077
BACKGROUND	In this study , we compared the efficacy and safety of the oral fluoropyrimidine S-1 as monotherapy or in combination with leucovorin as the second-line treatment for patients with metastatic pancreatic cancer whose disease had progressed on gemcitabine treatment .
METHODS	The study was a randomized , open-label , controlled study .
METHODS	Patients randomly received S-1 or S-1 in combination with leucovorin ( SL arm ) in 21-day cycles .
METHODS	The primary endpoint was the 6-month survival rate .
RESULTS	A total of 92 patients were randomized to S-1 ( n = 47 ) and SL ( n = 45 ) .
RESULTS	No statistically significant differences were observed between the two arms with regard to 6-month survival rates ( 40 % vs. 49 % ) , median overall survival ( 5.5 vs. 6.3 months ) , median progression-free survival ( 1.9 vs. 3.0 months ) , and overall response rate ( 4.7 % vs. 8.3 % ) .
RESULTS	The rate of major grade 3-4 adverse events of digestive toxicity was significantly higher in the SL arm than in the S-1 arm .
CONCLUSIONS	Compared with S-1 , SL did not improve the survival of patients with metastatic pancreatic cancer who had failed to benefit from prior gemcitabine treatment , but SL had a higher adverse event rate .

###24390887
OBJECTIVE	The purpose of this article was to test whether physical activity , healthy eating , and emotional well-being would improve if patients received feedback about biomarkers that have been shown to be responsive to changes in weight and fitness .
METHODS	Patients were randomized to limited feedback ( weight , body mass index [ BMI ] , and blood pressure at 4 and 10 months ) or enhanced feedback ( weight , BMI , blood pressure , homeostatic insulin resistance , and nuclear magnetic resonance lipoprotein profiles at 2 , 4 , 7 , and 10 months ) .
METHODS	Repeated measures mixed effects multivariate regression models were used to determine whether BMI , fitness , diet , and quality of life changed over time .
RESULTS	Major parameters were similar in both groups at baseline .
RESULTS	BMI , measures of fitness , healthy eating , quality of life , and health state improved in both patient groups , but there was no difference between patient groups at 4 or 10 months .
RESULTS	Systolic blood pressure improved in the enhanced feedback group , and there was a difference between the enhanced and limited feedback groups at 10 months ( 95 % confidence interval , -6.011 to -0.5113 ) .
CONCLUSIONS	Providing patients with enhanced feedback did not dramatically change outcomes .
CONCLUSIONS	However , across groups , many patients maintained or lost weight , suggesting the need for more study of nondiet interventions .

###25531191
OBJECTIVE	The aim of this study was to investigate the influence of PreloxR , a combination of French maritime pine bark extract ( Pycnogenol ) , L-arginine , L-citrulline and roburins , on male fertility .
METHODS	Sperm quality of 50 subfertile men was tested in monthly intervals in a double-blind , randomized , placebo controlled , crossover study .
METHODS	Patients received 2 tablets PreloxR or placebo twice daily during test periods .
METHODS	Following a run-in period of 1 month , patients received either PreloxR or a placebo for 1 month .
METHODS	After a wash-out period of 1 month , patients received PreloxR or a placebo in a crossover manner for 1 month .
METHODS	Sperm volume , concentration of spermatozoa , total count , motility , vitality and morphology were measured by standard methods of calculation of the Fertility Index ( FI ) in monthly intervals .
METHODS	Activity of e-NOS in sperm was evaluated in parallel by measuring the quantity of L-citulline produced from L-arginine .
RESULTS	Supplementation with PreloxR enhanced sperm volume and concentration , motility , vitality and morphology significantly versus placebo .
RESULTS	The Fertility Index rose to normal values during treatment with PreloxR .
RESULTS	e-NOS activity in sperm was elevated by PreloxR .
RESULTS	No adverse effects were reported .
CONCLUSIONS	PreloxR offers a safe method to improve quality of human spermatozoa in subfertile men .

###24759957
OBJECTIVE	The aim of this study was to assess whether or not a theory-based behaviour change intervention delivered by trained and quality-assured lifestyle facilitators can achieve and maintain improvements in physical activity , dietary change , medication adherence and smoking cessation in people with recently diagnosed type 2 diabetes .
METHODS	An explanatory randomised controlled trial was conducted in 34 general practices in Eastern England ( Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen Detected Diabetes in Primary Care-Plus [ ADDITION-Plus ] ) .
METHODS	In all , 478 patients meeting eligibility criteria ( age 40 to 69 years with recently diagnosed screen or clinically detected diabetes ) were individually randomised to receive either intensive treatment ( n = 239 ) or intensive treatment plus a theory-based behaviour change intervention led by a facilitator external to the general practice team ( n = 239 ) .
METHODS	Randomisation was central and independent using a partial minimisation procedure to balance stratifiers between treatment arms .
METHODS	Facilitators taught patients skills to facilitate change in and maintenance of key health behaviours , including goal setting , self-monitoring and building habits .
METHODS	Primary outcomes included physical activity energy expenditure ( individually calibrated heart rate monitoring and movement sensing ) , change in objectively measured fruit and vegetable intake ( plasma vitamin C ) , medication adherence ( plasma drug levels ) and smoking status ( plasma cotinine levels ) at 1 year .
METHODS	Measurements , data entry and laboratory analysis were conducted with staff unaware of participants ' study group allocation .
RESULTS	Of 475 participants still alive , 444 ( 93 % ; intervention group 95 % , comparison group 92 % ) attended 1-year follow-up .
RESULTS	There were no significant differences between groups in physical activity ( difference : +1.50 kJ kg ( -1 ) day ( -1 ) ; 95 % CI -1.74 , 4.74 ) , plasma vitamin C ( difference : -3.84 mol/l ; 95 % CI -8.07 , 0.38 ) , smoking ( OR 1.37 ; 95 % CI 0.77 , 2.43 ) and plasma drug levels ( difference in metformin levels : -119.5 mol/l ; 95 % CI -335.0 , 95.9 ) .
RESULTS	Cardiovascular risk factors and self-reported behaviour improved in both groups with no significant differences between groups .
CONCLUSIONS	For patients with recently diagnosed type 2 diabetes receiving intensive treatment in UK primary care , a facilitator-led individually tailored behaviour change intervention did not improve objectively measured health behaviours or cardiovascular risk factors over 1 year .
BACKGROUND	ISRCTN99175498 FUNDING : The trial is supported by the Medical Research Council , the Wellcome Trust , National Health Service R&D support funding ( including the Primary Care Research and Diabetes Research Networks ) and National Institute of Health Research under its Programme Grants for Applied Research scheme .
BACKGROUND	The Primary Care Unit is supported by NIHR Research funds .
BACKGROUND	Bio-Rad provided equipment for HbA1c testing during the screening phase .

###24309584
OBJECTIVE	Early poststroke aphasia rehabilitation effects and their functional MRI ( fMRI ) correlates were investigated in a pilot , controlled longitudinal study .
METHODS	Twelve patients with mild/moderate aphasia ( 8 Broca , 3 anomic , and 1 Wernicke ) were randomly assigned to daily language rehabilitation for 2 weeks ( starting 2.2 [ mean ] days poststroke ) or no rehabilitation .
METHODS	The Aachen Aphasia Test and fMRI recorded during an auditory comprehension task were performed at 3 time intervals : mean 2.2 ( T1 ) , 16.2 ( T2 ) , and 190 ( T3 ) days poststroke .
RESULTS	Groups did not differ in terms of age , education , aphasia severity , lesions volume , baseline fMRI activations , and in task performance during fMRI across examinations .
RESULTS	Rehabilitated patients significantly improved in naming and written language tasks ( P < 0.05 ) compared with no rehabilitation group both at T2 and T3 .
RESULTS	Functional activity at T1 was reduced in language-related cortical areas ( right and left inferior frontal gyrus and middle temporal gyrus , right inferior parietal lobule and superior temporal gyrus ) in patients compared with controls .
RESULTS	T2 and T3 follow-ups revealed a cortical activation increase , with significantly greater activation in the left hemisphere areas in rehabilitated patients at T2 and T3 , and a timetreatment effect at T2 in the left inferior Broca area after rehabilitation .
RESULTS	Left inferior frontal gyrus activation at T2 significantly correlated with naming improvement .
CONCLUSIONS	Early poststroke aphasia treatment is useful , has durable effects , and may lead to early enhanced recruitment of brain areas , particularly the left inferior frontal gyrus , which persists in the chronic phase .

###24479409
BACKGROUND	In this study , a combination of recombinant adenoviral p53 ( rAd-p53 ) gene therapy and intra-arterial delivery of chemotherapeutic agents for treatment of oral squamous cell carcinoma was evaluated .
METHODS	In total , 99 patients with stage III or IV oral carcinoma who had refused or were ineligible for surgery were enrolled in a randomized , placebo-controlled , double-blind , phase III clinical trial .
METHODS	They were randomly assigned to group I ( n = 35 ; intra-arterial infusion of rAd-p53 plus chemotherapy ) , group II ( n = 33 ; intra-arterial infusion of rAd-p53 plus placebo chemotherapy ) , or group III ( n = 31 ; intra-arterial infusion of placebo rAd-p53 plus chemotherapy ) .
RESULTS	The median length of follow-up was 36 months ( range , 3 to 86 months ) .
RESULTS	During follow-up , 16 patients in group I , 20 in group II , and 22 in group III died .
RESULTS	Group I ( 48.5 % ) had a higher complete response rate than groups II ( 16.7 % ) and III ( 17.2 % ) ( P = 0.006 ) .
RESULTS	The rate of non-responders in group I was significantly lower than that in groups II and III ( P < 0.020 ) .
RESULTS	A log-rank test for survival rate indicated that group I had a significantly higher survival rate than group III ( P = 0.019 ) .
RESULTS	The survival rate of patients with stage III but not stage IV oral cancer was significantly higher in group I than in group III ( P = 0.015 , P = 0.200 , respectively ) .
RESULTS	The survival rate of patients with stage IV did not differ significantly among the three groups .
RESULTS	Or the 99 patients , 63 patients experienced adverse events of either transient flu-like symptoms or bone marrow suppression , while 13 patients had both these conditions together .
RESULTS	No replication-deficient virus was detected in patient serum , urine , or sputum .
RESULTS	rAd-p53 treatment increased Bax expression in the primary tumor of 80 % of patients , as shown by immunohistochemical staining .
CONCLUSIONS	Intra-arterial infusion of combined rAd-p53 and chemotherapy significantly increased the survival rate of patients with stage III but not stage IV oral cancer , compared with intra-arterial chemotherapy .
CONCLUSIONS	Intra-arterial infusion of combined rAd-p53 and chemotherapy may represent a promising alternative treatment for oral squamous cell carcinoma .
BACKGROUND	ChiCTR-TRC-09000392 ( Date of registration : 2009-05-18 ) .

###24927259
OBJECTIVE	High bilirubin/albumin ( B/A ) ratios increase the risk of bilirubin neurotoxicity .
OBJECTIVE	The B/A ratio may be a valuable measure , in addition to the total serum bilirubin ( TSB ) , in the management of hyperbilirubinemia .
OBJECTIVE	We aimed to assess whether the additional use of B/A ratios in the management of hyperbilirubinemia in preterm infants improved neurodevelopmental outcome .
METHODS	In a prospective , randomized controlled trial , 615 preterm infants of 32 weeks ' gestation or less were randomly assigned to treatment based on either B/A ratio and TSB thresholds ( consensus-based ) , whichever threshold was crossed first , or on the TSB thresholds only .
METHODS	The primary outcome was neurodevelopment at 18 to 24 months ' corrected age as assessed with the Bayley Scales of Infant Development III by investigators unaware of treatment allocation .
METHODS	Secondary outcomes included complications of preterm birth and death .
RESULTS	Composite motor ( 100 13 vs. 101 12 ) and cognitive ( 101 12 vs. 101 11 ) scores did not differ between the B/A ratio and TSB groups .
RESULTS	Demographic characteristics , maximal TSB levels , B/A ratios , and other secondary outcomes were similar .
RESULTS	The rates of death and/or severe neurodevelopmental impairment for the B/A ratio versus TSB groups were 15.4 % versus 15.5 % ( P = 1.0 ) and 2.8 % versus 1.4 % ( P = 0.62 ) for birth weights 1000 g and 1.8 % versus 5.8 % ( P = 0.03 ) and 4.1 % versus 2.0 % ( P = 0.26 ) for birth weights of > 1000 g.
CONCLUSIONS	The additional use of B/A ratio in the management of hyperbilirubinemia in preterm infants did not improve their neurodevelopmental outcome .
BACKGROUND	Controlled-Trials .
BACKGROUND	com ISRCTN74465643 .

###25470782
OBJECTIVE	This study evaluated clinical pharmacy costs against drug costs .
METHODS	We conducted a randomized interventional comparative trial at the surgical intensive care unit ( ICU ) of Ghent University Hospital , Belgium ( period B : group B1 with pharmacist consultation ; control group B0 ) .
METHODS	We obtained before ( period A ) and after ( period C ) control groups using 1:1 propensity score matching with B1 and B0 .
METHODS	Mean daily ICU drug costs with standard error of the mean ( SEM ) were compared between B1 and B0 ( primary analysis ) and between matched pairs ( AB1 , AB0 , CB1 and CB0 ; secondary analysis ) .
METHODS	For B , we performed a 1000 bootstrapping ( by resampling B1 and B0 ) , calculated the benefit-cost ratio using pharmacy time ( gross salary ) as cost ( euros ) and drug cost savings as benefit .
METHODS	We performed sensitivity analysis with and without outlier drug costs ( i.e. twice the standard deviation ) .
CONCLUSIONS	Belgian health care payer .
RESULTS	In period B , 135 patients were randomized : B0 , n = 60 ; B1 , n = 75 .
RESULTS	Pharmacists provided recommendations in 148/706 ( 21.0 % ) therapies with 83.1 % acceptance .
RESULTS	Mean drug cost difference between B0 ( 430.6 euros , SEM 406.0 ) and B1 ( 221.2 euros , SEM 58.7 ) ( P = 0.870 ) became significant after excluding outlier drug costs ( B0 , 184.4 euros , SEM 42.5 ; B1 , 90.5 euros , SEM 17.7 ; P < 0.001 ) .
RESULTS	Recommendations were cost-beneficial ( break-even drug costs or savings ) in 53.8 % of patients with a benefit-cost ratio of 25:1 ( confidence interval -5:1 to 94:1 ) .
RESULTS	In sensitivity analysis excluding outlier drug costs , B0 costs were significantly higher than both A and C , indicating high baseline expenses in B0 .
CONCLUSIONS	The randomized interventional comparative trial in a small ICU patient group suggested the potential cost-benefit of clinical pharmacy on daily ICU drug costs .
CONCLUSIONS	However , after matching , this benefit was attenuated .
CONCLUSIONS	A final conclusion demands a larger randomized trial adopting a similar design with matched controls .
CONCLUSIONS	Future research should include clinical impact of recommendations .

###25331625
OBJECTIVE	ACT-246475 is a new reversible , selective , and potent antagonist of the platelet P2Y12 receptor .
OBJECTIVE	This study was a first-in-man trial investigating the tolerability , pharmacokinetics , and pharmacodynamics of single oral doses of ACT-246475 and its di-ester prodrug ( ACT-281959 ) in healthy males .
METHODS	The study had a double-blind , randomized , ascending single-dose design with an oral formulation F1 ( i.e. , ACT-281959 or placebo ) ( Part I ) and an open-label , randomized , 3-period , crossover design comparing exploratory formulations of ACT-281959 ( F2 ) 70mg and ACT-246475 ( dF ) 50mg to F1 70mg ( Part II ) .
METHODS	In Part I , doses up to 1,000 mg were tested in 40 healthy subjects .
METHODS	Nine healthy subjects were enrolled in Part II .
METHODS	Standard safety parameters , inhibition of platelet aggregation , and ACT-246475 plasma concentrations were measured .
METHODS	Non-compartmental pharmacokinetic analysis was performed .
RESULTS	All doses and formulations were well tolerated .
RESULTS	The most frequent adverse event was headache , whereas no events of bleeding or dyspnea were reported .
RESULTS	In Part I , ACT-246475 area under the plasma concentration-time curve ( AUC ) increased dose-proportionally whereas maximum plasma concentration ( C max ) was less than dose-proportional .
RESULTS	The highest C max [ geometric mean ( 95 % CI ) ] at 1,000 mg was 13.8 ( 9.7 , 19.5 ) pmol/mL at 4.5 h post-dose , terminal half-life ( t ) was ~ 10h .
RESULTS	ACT-246475 C max and AUC0 - ratios of geometric means ( 90 % CI ) using F1 as reference , for F2 were 8.5 ( 5.42 , 13.35 ) and 3.4 ( 2.40 , 4.82 ) , respectively , and for dF 2.2 ( 1.42 , 3.49 ) and 1.5 ( 1.07 , 2.16 ) , respectively .
RESULTS	Mean peak platelet inhibition was 31.0 % after F1 ( 1,000 mg ) and 47.8 % after F2 .
CONCLUSIONS	Oral doses of ACT-281959 and ACT-246475 were well tolerated .
CONCLUSIONS	Platelet inhibition correlated with ACT-246475 exposure .
CONCLUSIONS	Exploratory formulations enhanced the bioavailability and antiplatelet effect of ACT-246475 .

###24534073
OBJECTIVE	An inverse relationship between ( serum ) total bilirubin and risk of cardiovascular disease has been reported previously , but longitudinal data on overweight and obese patients are lacking .
OBJECTIVE	We have investigated the relationship between total bilirubin and cardiovascular adverse events in a large group of patients with risk factors for cardiovascular disease who were enrolled in a large weight loss trial .
RESULTS	Data from the Sibutramine Cardiovascular Outcomes ( SCOUT ) trial , including almost 10.000 overweight/obese high cardiovascular risk patients , were used .
RESULTS	The relationship between total bilirubin level at screening and the primary outcome ( i.e. non-fatal myocardial infarction , non-fatal stroke , resuscitated cardiac arrest or cardiovascular death ) for the entire study period was investigated using Cox proportional hazards models .
RESULTS	The population was divided into four groups based on total bilirubin levels ( normal range 5-25 mol/L ) .
RESULTS	Time-dependent Cox analyses were also performed to adjust for weight loss over time .
RESULTS	Initial analyses adjusted for sex , age and treatment allocation showed significantly reduced hazard ratios of 0.80 ( 95 % confidence interval 0.68-0 .94 ) , 0.73 ( 0.62-0 .86 ) and 0.77 ( 0.65-0 .91 ) , for the three higher total bilirubin groups : > 8 and 10 mol/L , > 10 and 13 mol/L and > 13 mol/L ( 5-95 interpercentile range for total bilirubin at screening ; 6-19 mol/L ) , compared to the lowest total bilirubin group 8 mol/L .
RESULTS	When adjusting for classical cardiovascular risk factors , estimates increased towards unity .
RESULTS	Additional adjustment for indicators of liver function did not alter the results .
RESULTS	A time-dependent Cox model , adjusted for weight loss , demonstrated a similar trend .
CONCLUSIONS	Bilirubin was not a risk-factor independent from other traditional cardiovascular risk-factors in our population .

###24401089
OBJECTIVE	This study investigated the effect of long-term niacin/laropiprant therapy on CV risk and IR in obese women with PCOS .
METHODS	In this double-blind randomized placebo-controlled trial , 13 and 12 PCOS women completed a 12week course of niacin/laropiprant or placebo , respectively .
METHODS	Fasted subjects had an endothelial function test ( EndoPat2000 ) and then consumed a mixed meal with blood sampled postprandially for 6h before and after intervention .
RESULTS	By 12weeks , niacin/laropiprant lowered low-density lipoprotein cholesterol ( LDL-c ) ( 13 % ) and increased HDL-c ( 17 % ) .
RESULTS	Despite a reduction in fasting triglycerides ( 21 % ) , the drug had no effect on their postprandial rise ( 2.691.44 vs. 2.491.14 mmol/l , p = 0.72 ) .
RESULTS	However , following the mixed meal , plasma glucose area under the response curve increased from 13.12.9 to 14.02.8 mmol/l , p = 0.05 , as a consequence of both increased insulin resistance [ HOMA-IR : 2.2 ( 1.2 , 4.2 ) vs. 3.8 ( 1.3 , 5.5 ) , p = 0.02 ] and a reduced acute insulin response to glucose [ 424 ( 211 , 975 ) vs. 257 ( 122 , 418 ) pmol/mmol , p = 0.04 ] .
RESULTS	Niacin/laropiprant did not improve RHI ( 1.970.40 vs. 2.050.58 , p = 0.33 ) or hsCRP .
CONCLUSIONS	In PCOS , niacin/laropiprant had a significant negative impact on postprandial glucose and no improvement in postprandial hypertriglyceridaemia , with at least the former mediated through increased IR and reduced - cell function .
CONCLUSIONS	This data may help explain why the improvement in fasting lipids has not translated into improved CV risk markers in PCOS .

###25032903
OBJECTIVE	Stressful events enhance risk for weight gain and adiposity .
OBJECTIVE	Ghrelin and leptin , two hormones that are implicated in appetite regulation , may link stressful events to weight gain ; a number of rodent studies suggest that stressors increase ghrelin production .
OBJECTIVE	The present study investigated the links among daily stressors , ghrelin and leptin , and dietary intake in humans .
METHODS	Women ( n = 50 ) completed three study appointments that were scheduled at least 2 weeks apart .
METHODS	At each visit , women arrived fasting and ate a standardized breakfast and lunch .
METHODS	Blood samples were collected 45min after each meal .
METHODS	Women completed a self-report version of the Daily Inventory of Stressful Events ( DISE ) at each appointment .
METHODS	Two composites were created from the DISE data , reflecting the number of stressors that did and did not involve interpersonal tension .
RESULTS	Women who experienced more stressors involving interpersonal tension had higher ghrelin and lower leptin levels than those who experienced fewer interpersonal stressors .
RESULTS	Furthermore , women who experienced more interpersonal stressors had a diet that was higher in calories , fat , carbohydrates , protein , sugar , sodium , and fiber , and marginally higher in cholesterol , vegetables ( but not fruits ) , vitamin A , and vitamin C. Stressors that did not involve interpersonal tension were unrelated to ghrelin and leptin levels or any of the dietary components examined .
CONCLUSIONS	These data suggest that ghrelin and leptin may link daily interpersonal stressors to weight gain and obesity .

###25490367
OBJECTIVE	comparative assessment of endoscopic and open exposure of the great saphenous vein during the operation of coronary artery bypass grafting .
METHODS	a total of 228 patients with endured coronary artery bypass graft operation were randomized depending on the method of exposing the great saphenous vein ( GSV ) - an open method of vein exposure ( OVE ) - 115 patients and endoscopic vein exposure ( EVE ) - 113 patients .
METHODS	The evaluated parameters included healing of the postoperative wounds , postoperative oedema , pain intensity , and neuropathies in the early postoperative period .
METHODS	We performed lymphoscintigraphy of the lower limbs , as well as morphological examination of the venous wall by means of light and electron scanning microscopy .
RESULTS	the duration of vein exposure was less in the EVE group than in the OVE group , amounting to 31.8 6.2 min and 40.3 15.8 min , respectively ( p < 0.01 ) .
RESULTS	Complications after GSV isolation were encountered considerably less often in the EVE group ( 11.5 % ) as compared to 44.4 % in the OVE ( p = 0.001 ) .
RESULTS	According to the results of the multivariate analysis , diabetes mellitus was the only risk factor for postoperative complications in OVE .
RESULTS	According the findings of lymphoscintigraphy the EVE group had no significant impairments of lymph outflow after the operation , whereas during OVE , accumulation of radiopaque material in the lymph nodes decreased twofold ( p 0.001 ) .
RESULTS	Histological assessment of the sampled vein specimens showed no considerable lesions of the venous wall in the examined groups .
CONCLUSIONS	the obtained findings confirm high efficacy of using EVE during operations of CABG , lower traumaticity of this method with a conduit of good quality , which was proven based on electron microscopy of the vein fragments .

###25638996
OBJECTIVE	Patients receiving long-term oral anticoagulant therapy pose a clinical challenge during invasive dental procedures .
OBJECTIVE	The goal of this study was to compare different local hemostatic modalities after tooth extraction in patients receiving chronic Vitamin-K antagonist therapy .
METHODS	Totally 90 patients with International Normalized Ratio ( INR ) 3.0 requiring simple extraction of one or two teeth were randomized into three groups , 30 patients in each group .
METHODS	The patients with the mean INR value of 2.35 0.37 , in whom extraction wound was sutured comprised the group A.
METHODS	In the group B with the mean INR of 2.43 0.4 , local hemostasis was achieved by placing absorbable gelatin sponges into the wound without suturing .
METHODS	The group C consisted of the patients with the mean INR of 2.36 0.34 in whom neither gelatin sponge nor suturing were used for providing local hemostasis .
METHODS	Bleeding was registered as an event if other than initial hemostatic measure was needed or additional oral surgeon intervention required .
RESULTS	The obtainded results show that 1 ( 3.3 % ) patient in the group A , 2 ( 6.7 % ) patients in the groups B and C manifested post-extraction bleeding .
RESULTS	All cases of hemorrhage were easily solved with local hemostatic measures and all , except one case , were registered in the first two hours after the procedure until the dismissal .
RESULTS	A difference between the groups was not statistically significant ( 2 = .42 , p > 0.05 ) .
CONCLUSIONS	In therapeutically anticoagulated patients tooth extractions can be safely performed without altering the dose of anticoagulant medication if efficient local hemostasis is provided .
CONCLUSIONS	In most cases ; in patients with INR 3.0 after extraction of one or two teeth postoperative bleeding can be controlled with local pressure , without any additional local hemostatic measures .

###24257551
BACKGROUND	A significant number of ovarian borderline tumors ( BOTs ) and metastatic nonovarian primaries are erroneously diagnosed as ovarian carcinomas .
BACKGROUND	If BOTs are misdiagnosed as cancer , patients may not only experience nonbeneficial morbidity but may have to cope with an incorrect diagnosis of cancer for the rest of their lives .
BACKGROUND	In cases of metastatic disease mistaken for an ovarian primary , more adequate therapeutic modalities may be withheld from some patients .
BACKGROUND	Finally , clinical trials may be biased through unintended disregard of histological inclusion criteria .
METHODS	Patients were recruited for central pathology review according to a translational subprotocol of a prospectively randomized phase 3 study led by the Arbeitsgemeinschaft Gynaekologische Onkologie ( AGO ) Study Group .
METHODS	All original slides were requested , and a specialized central pathology review was performed by experienced gynecopathologists .
METHODS	In cases of clinically relevant diagnostic discrepancies , the pathologist responsible for the original diagnosis was contacted .
METHODS	If a given discrepancy could not be resolved , a panel of experts was involved for clarification .
RESULTS	Four hundred fifty-four patients with an original diagnosis of ovarian , tubal , or peritoneal epithelial carcinoma were recruited .
RESULTS	In 6.8 % ( 31 patients ) , a major diagnostic discrepancy of clinical relevance was found .
RESULTS	Most frequently ( 15 patients ) , serous BOT had been misdiagnosed as invasive cancer .
RESULTS	Ovarian metastases constituted the second most frequent misdiagnosis ( 13 patients ) .
RESULTS	Minor discrepancies not affecting patient treatment were found in 28.2 % ( 128 patients ) .
CONCLUSIONS	Specialized central pathology review could help to avoid overtreatment of patients with BOT and inappropriate treatment of patients with ovarian metastases .
CONCLUSIONS	The implementation of a specialized case review process may translate into enhanced patient safety in clinical trials of ovarian carcinomas .
CONCLUSIONS	Furthermore , central pathology review may increase the rigor and ultimately the transferability of clinical research into practice and should therefore become a standard procedure in study protocols evaluating new therapies .

###25578925
BACKGROUND	Latino immigrants have high rates of obesity and face barriers to weight loss .
OBJECTIVE	To evaluate the effectiveness of a case-management ( CM ) intervention with and without community health workers ( CHWs ) for weight loss .
METHODS	This was a 2-year , randomized controlled trial comparing two interventions with each other and with usual care ( UC ) .
METHODS	Eligible participants included Latinos with a body mass index of 30 to 60 and one or more heart disease risk factors .
METHODS	The 207 participants recruited during 2009-2010 had a mean age of 47 years and were mostly women ( 77 % ) .
METHODS	At 24 months , 86 % of the sample was assessed .
METHODS	The CM+CHW ( n = 82 ) and CM ( n = 84 ) interventions were compared with each other and with UC ( n = 41 ) .
METHODS	Both included an intensive 12-month phase followed by 12 months of maintenance .
METHODS	The CM+CHW group received home visits .
METHODS	Weight change at 24 months .
METHODS	Generalized estimating equations using intent-to-treat .
RESULTS	At 6 months , mean weight loss in the CM+CHW arm was -2.1 kg ( 95 % CI -2.8 to -1.3 ) or -2 % of baseline weight ( 95 % CI -1 % to -2 % ) compared with -1.6 kg ( 95 % CI -2.4 to -0.7 ; % weight change , -2 % , -1 % , and -3 % ) in CM and -0.9 kg ( 95 % CI -1.8 to 0.1 ; % weight change , -1 % , 0 % , and -2 % ) in UC .
RESULTS	By 12 and 24 months , differences narrowed and CM+CHW was no longer statistically distinct .
RESULTS	Men achieved greater weight loss than women in all groups at each time point ( P < 0.05 ) .
RESULTS	At 6 months , men in the CM+CHW arm lost more weight ( -4.4 kg ; 95 % CI -6.0 to -2.7 ) compared with UC ( -0.4 kg ; 95 % CI -2.4 to 1.5 ) , but by 12 and 24 months differences were not significant .
CONCLUSIONS	This study demonstrated that incorporation of CHWs may help promote initial weight loss , especially among men , but not weight maintenance .
CONCLUSIONS	Additional strategies to address social and environmental influences may be needed for Latino immigrant populations .

###25656349
BACKGROUND	Heavy drinking is common during transitions from high school to college .
BACKGROUND	Optimal programs for diminishing risks for high alcohol consumption often tailor the approach to the specific needs of students .
BACKGROUND	This study describes the results of an Internet-based prevention protocol that tailors the information to the risk associated with a pre-existing phenotype , the Low level of Response ( Low LR ) to alcohol .
METHODS	Using stratified random assignment , 454 freshmen with Low and High LR values were assigned to 2 education groups ( LR-based where all examples were given the context of the Low LR model of heavy drinking or a State Of The Art ( SOTA ) Group where the same lessons were taught but without an emphasis on LR ) or a no-intervention Control Group .
METHODS	Individuals in the 2 education groups viewed 50-minute online videos once per week for 4weeks .
METHODS	Changes in drinking patterns were assessed at Baseline , 4weeks , and 8weeks using a 2 ( LR status ) by 3 ( education group ) by 3 ( time points ) analysis of variance , with additional tests for ethnicity and sex .
RESULTS	Low LR participants tended to decrease their usual ( p < 0.06 ) and maximum ( p < 0.05 ) drinks per occasion most prominently when assigned to the LR-based protocol , while those with High LRs improved more in the SOTA Group .
RESULTS	The most robust differences were seen when controlling for ethnicity .
RESULTS	The effect sizes were small to medium .
CONCLUSIONS	These results support the advantages of carrying out prevention via the Internet and in tailoring the approach to a pre-existing phenotype .

###24458541
OBJECTIVE	This paper describes the pharmacokinetic/pharmacodynamic modelling of clazosentan in patients with aneurysmal subarachnoid haemorrhage ( aSAH ) , and the impact of collecting data in an intensive care unit ( ICU ) setting .
OBJECTIVE	Factors influencing data quality , analysis , and interpretation are provided with recommendations for future clinical studies in ICU settings .
METHODS	CONSCIOUS-2 was a phase III study involving 1,157 patients with aSAH .
METHODS	Secured by surgical clipping , patients were infused with clazosentan or placebo for up to 14 days post-aSAH .
METHODS	Clazosentan exposure relationships with vital signs , QT intervals , and AST/ALT values as well as efficacy and safety endpoints were characterised using population PK/PD and logistic regression models .
RESULTS	Clazosentan clearance was influenced by age , sex , Asian origin , and disease status at baseline , and increased with time .
RESULTS	Volume of distribution showed a sex difference .
RESULTS	Exposure had no relationship with any efficacy endpoint or ALT/AST values , but was related to the increasing probability of lung complications .
RESULTS	Blood pressure decreased proportionally to clazosentan concentrations , and the presence of clazosentan was associated with QT interval increases .
RESULTS	Implausible values in the concentration data reflect the specific ICU challenges , possibly arising from PK sampling from the infusion arm or haemodilution .
CONCLUSIONS	Population PK/PD modelling of CONCIOUS-2 data provided clinically relevant knowledge about various effects of clazosentan in the aSAH patient population in a real clinical setting .
CONCLUSIONS	The quality of data and analyses could be improved by the collection of additional data and stricter training of study personnel .
CONCLUSIONS	Differences in clinical practice between sites and geographical regions are more challenging to overcome .

###24360787
BACKGROUND	Anthracyclines and taxanes have been the standard neoadjuvant chemotherapies for breast cancer in the past decade .
BACKGROUND	We aimed to assess safety and efficacy of the addition of gemcitabine to accelerated paclitaxel with epirubicin and cyclophosphamide , and also the effect of sequencing the blocks of epirubicin and cyclophosphamide and paclitaxel ( with or without gemcitabine ) .
METHODS	In our randomised , open-label , 22 factorial phase 3 trial ( Neo-tAnGo ) , we enrolled women ( aged > 18 years ) with newly diagnosed breast cancer ( tumour size > 20 mm ) at 57 centres in the UK .
METHODS	Patients were randomly assigned via a central randomisation procedure to epirubicin and cyclophosphamide then paclitaxel ( with or without gemcitabine ) or paclitaxel ( with or without gemcitabine ) then epirubicin and cyclophosphamide .
METHODS	Four cycles of each component were given .
METHODS	The primary endpoint was pathological complete response ( pCR ) , defined as absence of invasive cancer in the breast and axillary lymph nodes .
METHODS	This study is registered with EudraCT ( 2004-002356-34 ) , ISRCTN ( 78234870 ) , and ClinicalTrials.gov ( NCT00070278 ) .
RESULTS	Between Jan 18 , 2005 , and Sept 28 , 2007 , we randomly allocated 831 participants ; 207 received epirubicin and cyclophosphamide then paclitaxel ; 208 were given paclitaxel then epirubicin and cyclophosphamide ; 208 had epirubicin and cyclophosphamide followed by paclitaxel and gemcitabine ; and 208 received paclitaxel and gemcitabine then epirubicin and cyclophosphamide .
RESULTS	828 patients were eligible for analysis .
RESULTS	Median follow-up was 47 months ( IQR 37-51 ) .
RESULTS	207 ( 25 % ) patients had inflammatory or locally advanced disease , 169 ( 20 % ) patients had tumours larger than 50 mm , 413 ( 50 % ) patients had clinical involvement of axillary nodes , 276 ( 33 % ) patients had oestrogen receptor ( ER ) - negative disease , and 191 ( 27 % ) patients had HER2-positive disease .
RESULTS	Addition of gemcitabine did not increase pCR : 70 ( 17 % , 95 % CI 14-21 ) of 404 patients in the epirubicin and cyclophosphamide then paclitaxel group achieved pCR compared with 71 ( 17 % , 14-21 ) of 408 patients who received additional gemcitabine ( p = 098 ) .
RESULTS	Receipt of a taxane before anthracycline was associated with improved pCR : 82 ( 20 % , 95 % CI 16-24 ) of 406 patients who received paclitaxel with or without gemcitabine followed by epirubicin and cyclophosphamide achieved pCR compared with 59 ( 15 % , 11-18 ) of 406 patients who received epirubicin and cyclophosphamide first ( p = 003 ) .
RESULTS	Grade 3 toxicities were reported at expected levels : 173 ( 21 % ) of 812 patients who received treatment and had full treatment details had grade 3 neutropenia , 66 ( 8 % ) had infection , 41 ( 5 % ) had fatigue , 41 ( 5 % ) had muscle and joint pains , 37 ( 5 % ) had nausea , 36 ( 4 % ) had vomiting , 34 ( 4 % ) had neuropathy , 23 ( 3 % ) had transaminitis , 16 ( 2 % ) had acute hypersensitivity , and 20 ( 2 % ) had a rash .
RESULTS	86 ( 11 % ) patients had grade 4 neutropenia and 3 ( < 1 % ) had grade 4 infection .
CONCLUSIONS	Although addition of gemcitabine to paclitaxel and epirubicin and cyclophosphamide chemotherapy does not improve pCR , sequencing chemotherapy so that taxanes are received before anthracyclines could improve pCR in standard neoadjuvant chemotherapy for breast cancer .
BACKGROUND	Cancer Research UK , Eli Lilly , Bristol-Myers Squibb .

###24398317
OBJECTIVE	To compare the effects of intranasal application of black seed ( Nigella Sativa ) oil ( NSO ) and isotonic sodium chloride solution ( ISCS ) on nasal symptoms of the elderly .
METHODS	In this prospective , crossover randomized controlled trial , 42 geriatric patients with nasal dryness and related symptoms were randomized to receive either 2 weeks of isotonic sodium chloride solution ( ISCS ) followed by 2 weeks of N. sativa oil ( NG oil ) or the same treatment in the opposite order .
METHODS	There was a washout period of 3 weeks in between the treatment periods .
METHODS	Subjective symptoms including nasal dryness , burning , obstruction , itching and crusting were evaluated by a visual analog scale .
METHODS	Mucociliary function was evaluated with saccharin test .
RESULTS	Nasal dryness , obstruction and crusting improved significantly with the use of NSO compared to ISCS without any evidence of relevant carryover effects ( p < 0.05 for all for the difference in treatment ) .
RESULTS	There was no significant difference between the effect of NSO and ISCS on nasal burning and itching ( p > 0.05 for all ) .
RESULTS	There was no change in mucociliary clearance during any of the treatment periods .
CONCLUSIONS	NSO is a better alternative to ISCS to treat nasal mucosa symptoms due to aging .

###25740863
OBJECTIVE	To determine the relationship of glycated albumin ( GA ) and the recurrence of stroke in patients on either dual or single antiplatelet therapy .
METHODS	The Clopidogrel in High-Risk Patients with Acute Nondisabling Cerebrovascular Events trial randomized minor ischemic stroke or TIA patients to antiplatelet therapy of clopidogrel plus aspirin or aspirin alone .
METHODS	A subgroup of 3,044 consecutive patients with baseline GA levels from 73 ( 64 % ) prespecified clinical sites was analyzed .
METHODS	Patients were categorized into 2 groups based on GA level of 15.5 % , the cut point for development of diabetes .
METHODS	The primary outcome was stroke recurrence during 90-day follow-up .
METHODS	Cox proportional hazards models were used to assess the interaction of GA with randomized antiplatelet therapy on their risk of recurrent stroke .
RESULTS	Significant interaction of GA levels with the 2 antiplatelet therapy groups was found after adjustment for age , sex , and other conventional confounding factors ( p = 0.009 ) .
RESULTS	The interaction remained consistent after further adjustment for history of diabetes ( p = 0.010 ) .
RESULTS	In patients with lower GA level , stroke occurred in 5.5 % of patients in the clopidogrel-aspirin group , and 12.7 % in the aspirin group ( adjusted hazard ratio [ HR ] 0.40 ; 95 % confidence interval [ CI ] 0.26-0 .61 ; p < 0.001 ) .
RESULTS	Furthermore , in patients with elevated GA level , stroke occurred in 9.2 % of patients in the clopidogrel-aspirin group , and 11.4 % in the aspirin group ( adjusted HR 0.79 ; 95 % CI 0.60-1 .05 ; p = 0.103 ) .
CONCLUSIONS	GA could be a potential biomarker to predict the effects of dual and single antiplatelet therapy in patients with minor stroke or TIA .

###24568070
BACKGROUND	This study aimed to evaluate the validity and reliability of the Multidimensional Body Image Scale ( MBIS ) , a seven-factor , 62-item scale developed for Malaysian female adolescents .
BACKGROUND	This scale was evaluated among male and female Malaysian university students .
METHODS	A total of 671 university students ( 52.2 % women and 47.8 % men ) completed a self-administered questionnaire on MBIS , Eating Attitude Test-26 , and Rosenberg Self-Esteem Scale .
METHODS	Their height and weight were measured .
RESULTS	Results in confirmatory factor analysis showed that the 62-item MBIS reported poor fit to the data , xhi2/df = 4.126 , p < 0.001 , CFI = 0.808 , SRMR = 0.070 , RMSEA = 0.068 ( 90 % CI = 0.067 , 0.070 ) .
RESULTS	After re-specification of the model , the model fit was improved with 46 items remaining , chi2/df = 3.346 , p < 0.001 , CFI = 0.903 , SRMR = 0.053 , RMSEA = 0.059 ( 90 % CI = 0.057 , 0.061 ) , and the model showed good fit to the data for men and women separately .
RESULTS	This 46-item MBIS had good internal consistency in both men ( Cronbach 's alpha = 0.88 ) and women ( Cronbach 's alpha = 0.92 ) .
RESULTS	In terms of construct validity , it showed positive correlations with disordered eating and body weight status , but negative correlation with self-esteem .
RESULTS	Also , this scale discriminated well between participants with and without disordered eating .
CONCLUSIONS	The MBIS-46 demonstrated good reliability and validity for the evaluation of body image among university students .
CONCLUSIONS	Further studies need to be conducted to confirm the validation results of the 46-item MBIS .

###24672938
OBJECTIVE	To explore the effect of Qiling Decoction ( QD ) combined highly active antiretroviral treatment ( HAART ) on expression levels of peripheral blood Th17 and Treg cells in HIV/AIDS patients .
METHODS	Totally 55 HIV/AIDS patients were randomly assigned to the treatment group ( 28 cases ) and the combination group ( 27 cases ) .
METHODS	Besides , 21 HIV negative patients were recruited as the healthy control group .
METHODS	Those in the treatment group received HARRT alone , while those in the combination group received HAART combined QD .
METHODS	The observation lasted for 24 weeks .
METHODS	Meanwhile , according to peripheral blood CD4 + T cell counts before treatment , HIV/AIDS patients were assigned to three subgroups .
METHODS	For patients in subgroup 1 , 1 cells/microL < CD4 + T cell counts < or = 100 cells/microL ; For patients in subgroup 2 , 101 cells/microL < CD4 + T cell counts < or = 200 cells/lL ; For patients in subgroup 3 , 201 cells/microL < CD4 + T cell counts < or = 350 cells/microL .
METHODS	Expression of peripheral blood Th17 and Treg cells , and number of CD4 + T cell counts were detected using flow cytometry ( FCM ) in HIV/AIDS patients at the pre-treatment baseline , week 4 , 12 , and 24 , as well as those in the healthy control group .
RESULTS	Compared with the healthy control group , CD4 + T cell counts and the baseline expression level of Th17 cells in the peripheral blood of HIV/AIDS patients significantly decreased , the expression level of Treg cells significantly increased P < 0.01 ) .
RESULTS	Compared with before treatment in the same group , CD4 + T cell counts all increased at week 4 , 12 , and 24 in the two treatment groups , showing statistical difference ( P < 0.05 , P < 0.01 ) .
RESULTS	There was no statistical difference in the effective rate at various CD4 + T cell levels between the two groups ( P > 0.05 ) .
RESULTS	There was no statistical difference in expression levels of Th17 and Treg cells between the combination group and the treatment group at any time point ( all P > 0.05 ) .
RESULTS	The Th17/Treg ration significantly increased in the combination group after 24 weeks of treatment , showing statistical difference when compared with the treatment group ( U = 2.135 , P = 0.038 ) .
CONCLUSIONS	QD could improve the immune balance of Th17/Treg cells , which might be one of its mechanisms for improving HIV/AIDS patients ' immunity .

###25493596
OBJECTIVE	Trimethoprim-sulfamethoxazole prophylaxis is recommended for HIV-exposed infants until breastfeeding ends and HIV infection has been excluded .
OBJECTIVE	Extending prophylaxis with a focus on preventing malaria may be beneficial in high transmission areas .
OBJECTIVE	We investigated three regimens for the prevention of malaria in young HIV-exposed children .
METHODS	An open-label , randomized controlled trial .
METHODS	Tororo , Uganda , a rural area with intense , year-round , malaria transmission .
METHODS	Two hundred infants aged 4-5 months enrolled and 186 randomized after cessation of breastfeeding and confirmed to be HIV uninfected ( median 10 months of age ) .
METHODS	No chemoprevention , monthly sulfadoxine-pyrimethamine , daily trimethoprim-sulfamethoxazole or monthly dihydroartemisinin-piperaquine given from randomization to 24 months of age .
METHODS	The primary outcome was the incidence of malaria during the intervention period .
METHODS	Secondary outcomes included the incidence of hospitalization , diarrhoeal illness , or respiratory tract infection ; prevalence of anaemia and asymptomatic parasitemia ; measures of safety ; and incidence of malaria over 1 year after the intervention was stopped .
RESULTS	During the intervention , the incidence of malaria in the no chemoprevention group was 6.28 episodes per person-year at risk .
RESULTS	Protective efficacy was 69 % [ 95 % confidence interval ( 95 % CI ) 53-80 , P < 0.001 ] for dihydroartemisinin-piperaquine , 49 % ( 95 % CI 23-66 , P = 0.001 ) for trimethoprim-sulfamethoxazole and 9 % for sulfadoxine-pyrimethamine ( 95 % CI -35 to 38 , P = 0.65 ) .
RESULTS	There were no significant differences in any secondary outcomes , with the exception of a lower prevalence of asymptomatic parasitemia in the dihydroartemisinin-piperaquine arm .
CONCLUSIONS	Monthly chemoprevention with dihydroartemisinin-piperaquine was well tolerated and associated with a significant reduction in malaria in young HIV-exposed children .

###25304277
OBJECTIVE	To compare the outcome of fornix-based trabeculectomy with mitomycin C ( MMC ) using 2 different sizes of subconjunctival preparation ( 36 mm compared with 72 mm ) .
METHODS	Prospective , randomized interventional case series .
METHODS	Patients 18 to 85 years of age with open-angle glaucoma and progressive visual field defects under maximum tolerated medical therapy were randomized to undergo initial fornix-based trabeculectomy with MMC ( 0.2 mg/mL for 5 min ) with subconjunctival preparation of 66 mm ( group A ) or 89 mm ( group B ) .
METHODS	Main outcome parameters were : intraocular pressure ( IOP ) , best-corrected visual acuity ( BCVA ) , number of 5-fluorouracil ( 5-FU ) injections , and laser suturolyses ( SL ) .
RESULTS	Twenty-eight eyes of 26 patients were enrolled , including 14 eyes in group A and 14 in group B.
RESULTS	At 12 months , IOP ( meanSD ) was 9.692.5 mm Hg in group A and 9.933.2 mm Hg in group B ( P = 0.17 ) without glaucoma medication .
RESULTS	Mean BCVA ( logMAR ) at month 12 was 0.290.26 in group A and 0.260.2 in group B ( P = 0.71 ) .
RESULTS	Patients required 3.0 5-FU in group A and 4.12.9 5-FU in group B ( P = 0.16 ) ; 1.31.1 SL and 1.81.1 SL , respectively ( P = 0.23 ) .
RESULTS	We noted 2 cases of intraocular hypotony in the 66 mm group ( 14.3 % ) and 1 in the 89 mm group ( 7.1 % ) .
CONCLUSIONS	There were no significant differences between study groups in mean IOP reduction , change in BCVA , or number of applied 5-FU and SL at 1-year follow-up .
CONCLUSIONS	The area of subconjunctival preparation is only one of several factors playing a role in the outcome of trabeculectomy with MMC .

###24527467
OBJECTIVE	To compare the postoperative analgesic characteristics and side effects of two different doses of intrathecal dexmedetomidine in combination with hyperbaric bupivacaine , and to evaluate the effects of these combinations on spinal anesthesia .
METHODS	After obtaining approval from the local ethics committee , 60 male patients who were undergoing inguinal surgery and were classified as American Society of Anesthesiologists physical status class I were included in the study .
METHODS	The present study was conducted in 2003 in a military hospital with a capacity of 100 beds .
METHODS	The patients were randomly assigned to three groups of 20 patients : group 1 , 0.5 mL saline added to 3 mL ( 15 mg ) hyperbaric bupivacaine ; and groups 2 and 3 , 2 g dexmedetomidine and 4 g dexmedetomidine added to 3 mL ( 15 mg ) hyperbaric bupivacaine , respectively .
METHODS	Medications were administered by intrathecal injection in a total volume of 3.5 mL .
METHODS	The postoperative analgesic characteristics , effects on spinal anesthesia and side effects were recorded .
RESULTS	Demographic characteristics were similar among the groups .
RESULTS	The mean ( SD ) time to onset of pain was 220.75112.7 min in group 1 , 371.5223.5 min in group 2 and 1042.50366.78 min in group 3 .
RESULTS	Time to first pain sensation in group 3 was significantly longer than that in groups 1 and 2 ( P < 0.001 ) .
CONCLUSIONS	Two different doses of dexmedetomidine , an 2-adrenoceptor agonist with analgesic effects , resulted in an increased duration of analgesia and efficacy , decreased postoperative analgesic use and was associated with no notable adverse effects .

###25884824
BACKGROUND	New technologies have recently been used for monitoring signs and symptoms of mental health illnesses and particularly have been tested to improve the outcomes in bipolar disorders .
BACKGROUND	Web-based psychoeducational programs for bipolar disorders have also been implemented , yet to our knowledge , none of them have integrated both approaches in one single intervention .
BACKGROUND	The aim of this project is to develop and validate a smartphone application to monitor symptoms and signs and empower the self-management of bipolar disorder , offering customized embedded psychoeducation contents , in order to identify early symptoms and prevent relapses and hospitalizations .
METHODS	The project will be carried out in three complementary phases , which will include a feasibility study ( first phase ) , a qualitative study ( second phase ) and a randomized controlled trial ( third phase ) comparing the smartphone application ( SIMPLe ) on top of treatment as usual with treatment as usual alone .
METHODS	During the first phase , feasibility and satisfaction will be assessed with the application usage log data and with an electronic survey .
METHODS	Focus groups will be conducted and technical improvements will be incorporated at the second phase .
METHODS	Finally , at the third phase , survival analysis with multivariate data analysis will be performed and relationships between socio-demographic , clinical variables and assessments scores with relapses in each group will be explored .
CONCLUSIONS	This project could result in a highly available , user-friendly and not costly monitoring and psychoeducational intervention that could improve the outcome of people suffering from bipolar disorders in a practical and secure way .
BACKGROUND	Clinical Trials.gov : NCT02258711 ( October 2014 ) .

###24552970
BACKGROUND	Standard print and verbal information provided to patients undergoing treatments are often difficult to understand and may impair their ability to be truly informed .
BACKGROUND	This study examined the effect of an interactive multimedia informational program with in-line exercises and corrected feedback on patients ' real-time understanding of their cardiac catheterization procedure .
METHODS	151 adult patients scheduled for diagnostic cardiac catheterization were randomized to receive information about their procedure using either the standard institutional verbal and written information ( SI ) or an interactive iPad-based informational program ( IPI ) .
METHODS	Subject understanding was evaluated using semi-structured interviews at baseline , immediately following catheterization , and 2 weeks after the procedure .
METHODS	In addition , for those randomized to the IPI , the ability to respond correctly to several in-line exercises was recorded .
METHODS	Subjects ' perceptions of , and preferences for the information delivery were also elicited .
RESULTS	Subjects randomized to the IPI program had significantly better understanding following the intervention compared with those randomized to the SI group ( 8.32.4 vs 7.42.5 , respectively , 0-12 scale where 12 = complete understanding , P < 0.05 ) .
RESULTS	First-time correct responses to the in-line exercises ranged from 24.3 % to 100 % .
RESULTS	Subjects reported that the in-line exercises were very helpful ( 9.11.7 , 0-10 scale , where 10 = extremely helpful ) and the iPad program very easy to use ( 9.01.6 , 0-10 scale , where 10 = extremely easy ) suggesting good clinical utility .
CONCLUSIONS	Results demonstrated the ability of an interactive multimedia program to enhance patients ' understanding of their medical procedure .
CONCLUSIONS	Importantly , the incorporation of in-line exercises permitted identification of knowledge deficits , provided corrected feedback , and confirmed the patients ' understanding of treatment information in real-time when consent was sought .

###24498872
BACKGROUND	Compared with younger patients , older adults with acute myeloid leukemia ( AML ) generally have poorer survival outcomes and less benefit from clinical trials .
BACKGROUND	A recent phase 3 trial demonstrated a trend toward improved overall survival ( OS ) with decitabine , a hypomethylating agent , compared with treatment choice of either cytarabine or supportive care ( 7.7 months , 95 % CI : 6.2-9 .2 vs 5.0 months , 95 % CI : 4.3-6 .3 , respectively ) in older adults with newly diagnosed AML .
BACKGROUND	The current analyses investigated prognostic factors for outcomes in this trial and examined OS and responses in prespecified subgroups .
METHODS	A multivariate Cox proportional hazards model was used to investigate effects of demographic and baseline characteristics , including age , sex , cytogenetic risk , AML type , ECOG Performance Status , geographic region , bone marrow blasts , platelets , and white blood cells on OS , based on mature data .
METHODS	Similar analyses were conducted with a logistic regression model to predict response rates .
METHODS	Prespecified subgroup analyses were performed for OS and response rates , also using mature data .
RESULTS	Patient characteristics that appeared to negatively influence OS included more advanced age ( hazard ratio [ HR ] 1.560 for 75 vs < 70 years ; p = 0.0010 ) , poorer performance status at baseline ( HR 0.771 for 0 or 1 vs 2 ; p = 0.0321 ) , poor cytogenetics ( HR 0.699 for intermediate vs poor ; p = 0.0010 ) , higher bone marrow blast counts ( HR 1.355 for > 50 % vs 50 % ; p = 0.0045 ) , low baseline platelet counts ( HR 0.775 for each additional 100 109/L ; p = 0.0015 ) , and high white blood cell counts ( HR 1.256 for each additional 25 109/L ; p = 0.0151 ) .
RESULTS	Regarding geographic regions , patients from Western Europe had the longest median OS .
RESULTS	Response rates favored decitabine for all subgroups investigated , including patients 75 years ( odds ratio 5.94 , p = 0.0006 ) .
CONCLUSIONS	Response to decitabine in AML is associated with known prognostic factors related to both patient demographics and disease characteristics .
BACKGROUND	ClinicalTrials.gov identifier NCT00260832 .

###25219699
OBJECTIVE	We present the 1-year results of the GOLIATH prospective randomized controlled trial comparing transurethral resection of the prostate to GreenLight XPS for the treatment of men with nonneurogenic lower urinary tract symptoms due to prostate enlargement .
OBJECTIVE	The updated results at 1 year show that transurethral resection of the prostate and GreenLight XPS remain equivalent , and confirm the therapeutic durability of both procedures .
OBJECTIVE	We also report 1-year followup data from several functional questionnaires ( OABq-SF , ICIQ-SF and IIEF-5 ) and objective assessments .
METHODS	A total of 291 patients were enrolled at 29 sites in 9 European countries .
METHODS	Patients were randomized 1:1 to undergo GreenLight XPS or transurethral resection of the prostate .
METHODS	The trial was designed to evaluate the hypothesis that GreenLight XPS is noninferior to transurethral resection of the prostate on the International Prostate Symptom Score at 6 months .
METHODS	Several objective parameters were assessed , including maximum urinary flow rate , post-void residual urine volume , prostate volume and prostate specific antigen , in addition to functional questionnaires and adverse events at each followup .
RESULTS	Of the 291 enrolled patients 281 were randomized and 269 received treatment .
RESULTS	Noninferiority of GreenLight XPS was maintained at 12 months .
RESULTS	Maximum urinary flow rate , post-void residual urine volume , prostate volume and prostate specific antigen were not statistically different between the treatment arms at 12 months .
RESULTS	The complication-free rate at 1 year was 84.6 % after GreenLight XPS vs 80.5 % after transurethral resection of the prostate .
RESULTS	At 12 months 4 patients treated with GreenLight XPS and 4 who underwent transurethral resection of the prostate had unresolved urinary incontinence .
CONCLUSIONS	Followup at 1 year demonstrated that photoselective vaporization of the prostate produced efficacy outcomes similar to those of transurethral resection of the prostate .
CONCLUSIONS	The complication-free rates and overall reintervention rates were comparable between the treatment groups .

###25403296
OBJECTIVE	To investigate the dynamics of behavioral indicators , attention and memory in children with attention deficit hyperactivity disorder ( ADHD ) treated with noofen ( capsules 250 mg ) .
METHODS	In an open study , 50 patients were randomized to 2 equal groups : patients of group 1 were treated with noofen ( 15-20 mg/kg ( 500-700 mg ) per day perorally in 2-3 doses ) ; the control group received low doses of multivitamins .
METHODS	Duration of treatment was one month .
RESULTS	The results of neuropsychological testing revealed the improvement of cognitive functions , including the indicators of self-control , sustained , directed and divided attention , acoustic-verbal memory , to the end of treatment .
CONCLUSIONS	The initial positive changes may be the basis for obtaining better clinical results during long-term treatment .

###25840580
BACKGROUND	Occurrence of atrial fibrillation after cardiac surgery is associated with long-term mortality .
BACKGROUND	We investigated whether infusion of human atrial natriuretic peptide ( carperitide ) could prevent postoperative atrial fibrillation .
RESULTS	A total of 668 patients who underwent isolated coronary artery bypass grafting were randomized to receive infusion of carperitide or physiological saline from the initiation of cardiopulmonary bypass .
RESULTS	Patients were monitored continuously for 1 week after surgery to detect atrial fibrillation .
RESULTS	The risk factors were investigated by Cox proportional hazard model .
RESULTS	Postoperative atrial fibrillation occurred in 41 of 335 patients ( 12.2 % ) from the carperitide group versus 110 of 333 patients ( 32.7 % ) from the placebo group ( P < 0.0001 ) .
RESULTS	Postoperative levels of angiotensin-II , aldosterone , creatine kinase MB isoenzyme , human heart fatty acid-binding protein , and brain natriuretic peptide were all significantly lower in the carperitide group .
RESULTS	The risk factors for postoperative atrial fibrillation by the Cox proportional hazard model were an age 70 years , emergency surgery , preoperative aldosterone level > 150 ng/mL , preoperative nonuse of angiotensin receptor antagonists , preoperative use of calcium antagonists , postoperative nonuse of - blockers , postoperative nonuse of aldosterone blockers , and nonuse of carperitide .
CONCLUSIONS	- Perioperative carperitide infusion reduced the occurrence of postoperative atrial fibrillation .
CONCLUSIONS	Accordingly , carperitide could be a useful option for preventing postoperative atrial fibrillation .
BACKGROUND	- URL : http://www.umin.ac.jp .
BACKGROUND	Unique Identifier : UMIN000003958 .

###24620654
OBJECTIVE	To explore the curative effect of nasal type extranodal NK/T-cell lymphoma by sequential chemotherapy combined radiotherapy compared with chemtherapy .
METHODS	Fifty-seven cases of nasal type extranodal NK/T-cell lymphoma confirmed by pathological morphology and immuno-histochemistry were divided into chemotherapy combined radiotherapy group ( 34 cases ) or chemotherapy group ( 23 cases ) .
METHODS	Twenty-three patients in the chemotherapy group alternately applied CHOP , VDLP and MEOP regimen after each two treatments into the clinical observation ; Chemotherapy combined radiotherapy group of 34 patients , in addition to the above chemotherapy , applied three-dimensional conformal radiation therapy of the primary site by linear accelerators .
METHODS	Then all of patients were ceased treatment and followed up 3-5 years .
RESULTS	( 1 ) After treatment , effective rate of two groups was 91.2 % and 87.0 % , there was no obvious difference ( P > 0.05 ) ; After follow up about 1 year , effective rate of two groups was 76.5 % and 73.9 % , there was no obvious difference ( P > 0.05 ) ; ( 3 ) After follow up about 3 years and 5 years , disease free survival ( DFS ) of two groups was 61.3 % , 47.6 % and 43.5 % , 21.4 % , there was obvious difference ( P < 0.05 ) .
RESULTS	( 4 ) Long-term survival is closely related to treatment mode .
RESULTS	( 5 ) B symptoms , advanced ( III , IV ) stage , the International Prognostic Index ( IPI ) , KPS scores were correlated with prognosis , and were independent prognostic factors .
CONCLUSIONS	Treatment with chemotherapy and radiotherapy for nasal type extranodal NK/T-cell lymphoma had obvious curative effect and may improve long-term survival efficiently compared with chemotherapy alone .

###25788164
BACKGROUND	Antiviral drugs are a proposed medical intervention to reduce household transmission of influenza viruses .
BACKGROUND	In a previously described randomised , placebo-controlled trial in Dhaka , Bangladesh , we showed that oseltamivir treatment of index patients was able to reduce influenza symptom duration and virus shedding .
BACKGROUND	In a further analysis that is part of the same study , we aimed to assess efficacy of oseltamivir to reduce secondary household illnesses in the same cohort .
METHODS	In this double-blind oseltamivir efficacy trial , we identified index patients aged older than 1 year through surveillance of households in Dhaka , Bangladesh .
METHODS	We randomly allocated eligible patients ( 1:1 ) to receive oseltamivir or placebo twice-daily for 5 days , and we stratified them by enrolment 48 h versus 48-120 h since illness onset .
METHODS	Participants provided nasal wash specimens at enrolment and 2 , 4 , and 7 days after enrolment and were visited daily by a research assistant to record symptoms , both in index patients and in household members .
METHODS	For this part of the study , household members were asked to give respiratory specimens for influenza PCR testing .
METHODS	Our primary outcomes were household secondary illness and PCR-confirmed influenza virus infection , assessed in household members of all randomly allocated index patients .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00707941 .
RESULTS	From May 11 , 2008 , to Dec 31 , 2010 , we enrolled 1190 index patients with 4694 household members .
RESULTS	592 patients were allocated to placebo ( 2292 household members ) and 598 to oseltamivir ( 2402 household members ) .
RESULTS	Household secondary illness was lower in the oseltamivir group ( 196 [ 8 % ] influenza cases ) than in the placebo group ( 233 [ 10 % ] ; odds ratio [ OR ] 077 , 95 % CI 060-098 , p = 0031 ) .
RESULTS	PCR-confirmed influenza virus infection did not differ between the placebo ( 103 [ 5 % ] ) and oseltamivir groups ( 92 [ 4 % ] ; 084 , 059-119 , p = 0319 ) ; however , only 243 ( 57 % ) of ill household members gave a specimen for analysis .
CONCLUSIONS	In a crowded , low income setting , oseltamivir treatment of index patients resulted in a small reduction of secondary influenza in their households .
CONCLUSIONS	Even this slight reduction , in the setting of widespread antiviral use during a community influenza outbreak , might result in reductions in overall disease burden .
BACKGROUND	Centers for Disease Control and Prevention ( in an agreement with the International Centre for Diarrhoeal Disease Research , Bangladesh ) .

###25629819
OBJECTIVE	Mobile applications on smartphones can communicate a large amount of personalized , real-time health information , including advice on skin cancer prevention , but their effectiveness may be affected by whether recipients can be convinced to use them .
OBJECTIVE	To evaluate a smartphone mobile application ( Solar Cell ) delivering real-time advice about sun protection for a second time in a randomized clinical trial .
METHODS	A previous trial conducted in 2012 used a randomized pretest-posttest design .
METHODS	For the present trial , we collected data from a volunteer sample of 202 adults 18 years or older who owned a smartphone .
METHODS	Participants were recruited nationwide through online promotions .
METHODS	Screening procedures and a 3-week run-in period were added to increase the use of the mobile application .
METHODS	We conducted follow-ups at 3 and 8 weeks after randomization to examine the immediate and the longer-term effects of the intervention .
METHODS	Use of the mobile application .
METHODS	The application gave feedback on sun protection ( ie , sun-safety practices and the risk for sunburn ) and alerted users to apply or to reapply sunscreen and to get out of the sun .
METHODS	The application also displayed the hourly UV Index and vitamin D production based on the forecast UV Index , time , and location .
METHODS	Percentage of days with the use of sun protection , time spent outdoors in the midday sun ( days and hours ) , and the number of sunburns in the last 3 months .
RESULTS	Participants in the intervention group used wide-brimmed hats more at 7 weeks than control participants ( 23.8 % vs 17.4 % ; F = 4.07 ; P = .045 ) .
RESULTS	Women who used the mobile application reported using all sun protection combined more than men ( 46.4 % vs 43.3 % ; F = 1.49 ; P = .04 ) , whereas men and older individuals reported less use of sunscreen ( 32.7 % vs 35.5 % ; F = 5.36 ; P = .02 ) and hats ( 15.6 % vs 17.9 % ; F = 4.72 ; P = .03 ) .
CONCLUSIONS	The mobile application initially appeared to confer weak improvement of sun protection .
CONCLUSIONS	Use of the mobile application was greater than in a previous trial and was associated with greater sun protection , especially among women .
CONCLUSIONS	Strategies to increase the use of the mobile application are needed if the application is to be deployed effectively to the general adult population .

###24811202
BACKGROUND	Internet-based Smoking Cessation Interventions could help pregnant women quit smoking , especially those who do not wish to , or can not , access face-to-face or telephone support .
BACKGROUND	This study aimed to preliminarily evaluate the effectiveness and usage of a fully automated smoking cessation website targeted to pregnancy , ` MumsQuit ' , and obtain an initial effect-size estimate for a full scale trial .
METHODS	We recruited 200 UK-based pregnant adult smokers online to a two-arm double-blind pilot RCT assessing the effectiveness of MumsQuit compared with an information-only website .
METHODS	MumsQuit was adapted from a generic internet smoking cessation intervention , ` StopAdvisor ' .
METHODS	The primary outcome was self-reported continuous 4-week abstinence assessed at 8 weeks post-baseline .
METHODS	Secondary outcomes were automatically collected data on intervention usage .
RESULTS	Participants smoked 15 cigarettes per day on average , 73 % were in the first trimester of their pregnancy , 48 % were from lower socioeconomic backgrounds , and 43 % had never used evidence-based cessation support .
RESULTS	The point estimate of odds ratio for the primary outcome was 1.5 ( 95 % CI = 0.8-2 .9 ; 28 % vs. 21 % ) .
RESULTS	Compared with control participants , those in the MumsQuit group logged in more often ( 3.5 vs. 1.3 , p < 0.001 ) , viewed more pages ( 67.4 vs. 5.7 , p < 0.001 ) and spent more time browsing the website ( 21.3 min vs. 1.0 min , p < 0.001 ) .
CONCLUSIONS	MumsQuit is an engaging and potentially helpful form of support for pregnant women who seek cessation support online , and merits further development and evaluation in a full-scale RCT .

###24862342
OBJECTIVE	Acute bronchiolitis is the most frequent lower respiratory tract infection in infants , yet there are no effective therapies available .
OBJECTIVE	Current evidence is unclear about the role of hypertonic saline ( HS ) for the acute treatment of bronchiolitis .
OBJECTIVE	To determine whether nebulized 3 % HS compared with normal saline ( NS ) improves respiratory distress in infants with bronchiolitis not responding to standard treatments in the emergency department .
METHODS	A randomized clinical trial with blinding of investigators , health care providers , and parents was conducted at a single urban pediatric ED .
METHODS	The participants included children aged 2 to less than 24 months with their first episode of bronchiolitis and a Respiratory Distress Assessment Instrument score of 4 to 15 after nasal suctioning and a trial of nebulized albuterol .
METHODS	Patients were randomized to receive either nebulized 3 % HS ( HS group ) or NS ( NS group ) .
METHODS	The primary outcome was change in respiratory distress at 1 hour after the intervention , as measured by the Respiratory Assessment Change Score ( a decrease indicates improvement ) .
METHODS	Secondary outcomes included vital signs , oxygen saturation , hospitalization , physician clinical impression , parental assessment , and adverse events .
RESULTS	The 31 patients enrolled in each treatment arm had similar baseline demographic and clinical characteristics .
RESULTS	At 1 hour after the intervention , the HS group demonstrated significantly less improvement in the median Respiratory Assessment Change Score compared with the NS group ( HS , -1 [ interquartile range , -5 to 1 ] vs. NS , -5 [ interquartile range , -6 to -2 ] ; P = .01 ) .
RESULTS	There were no significant differences in heart rate , oxygen saturation , hospitalization rate , or other outcomes .
RESULTS	There were no adverse events .
CONCLUSIONS	Infants with bronchiolitis and persistent respiratory distress after standard treatment in the emergency department had less improvement after receiving 3 % HS compared with those who received NS .
CONCLUSIONS	Based on these results and the existing evidence , administration of a single dose of 3 % HS does not appear to be indicated to treat bronchiolitis in the acute care setting .
BACKGROUND	clinicaltrials.gov Identifier : NCT01247064 .

###24667460
OBJECTIVE	This study aimed to assess the efficacy and safety of our newly developed nasal glucagon-like peptide-1 ( GLP-1 ) compound and injector .
METHODS	Twenty-six patients with type 2 diabetes were enrolled in this double-blind placebo-controlled study .
METHODS	The nasal compound containing 1.2 mg of human GLP-1 ( 7-36 ) amide or placebo was administered immediately before every meal for 2 weeks .
RESULTS	The plasma peak concentration of active GLP-1 was 47.2 pmol/L , and its Tmax was 8.1 min .
RESULTS	The early phase of insulin and glucagon secretion were recovered and suppressed , respectively , in the GLP-1 group .
RESULTS	Glycoalbumin levels became significantly lower and 1,5-anhydroglucitol levels significantly higher after GLP-1 administration .
RESULTS	No marked adverse events were observed after using nasal GLP-1 .
CONCLUSIONS	The newly developed nasal GLP-1 compound may be a potential treatment for type 2 diabetes .
CONCLUSIONS	The long-term application of the drug should be evaluated in future trials .

###25631171
BACKGROUND	Effective wound closure is critical to minimizing wound complications and withstanding the forces associated with early knee motion after TKA .
BACKGROUND	Barbed sutures allow for knotless fixation , have been used successfully in other specialties , and may provide for more even distribution of tension along the length of the incision ; however , data regarding unidirectional barbed sutures from randomized trials have raised important concerns about their use .
BACKGROUND	Bidirectional barbed sutures offer a potential alternative , but have not been studied extensively in orthopaedic surgery .
OBJECTIVE	Using a prospective , randomized , within-patient controlled study design I compared wound closure performed with bidirectional barbed sutures in one knee of bilateral TKAs performed under the same anesthetic with those performed with standard sutures in the other knee to determine whether the barbed suture was associated with ( 1 ) faster closure times ; ( 2 ) fewer intraoperative suture issues , such as needle sticks or suture breakage , and fewer postoperative wound complications ; ( 3 ) no detrimental effect on clinical outcomes , including knee ROM and Knee Society scores ; and ( 4 ) lower total operative cost , considering suture material cost and operating room time savings .
METHODS	Between 2011 and 2012 , 50 consecutive patients meeting prespecified inclusion criteria with simultaneous bilateral TKAs had deep and superficial closures performed using interrupted and running standard sutures in one randomly assigned knee , and running knotless bidirectional barbed sutures in the other knee .
METHODS	The barbed suture is US FDA-approved for soft tissue approximation wherever absorbable sutures are appropriate .
METHODS	Intraoperative suture issues and the number of sutures used were recorded at the time of wound closure .
METHODS	Suture cost was compared between the standard and barbed sutures and measured against the operative time cost , as estimated per minute saved .
METHODS	Patients were followed postoperatively at 2 , 6 , and 12weeks , and 1year .
METHODS	Outcomes assessed included detailed operative and tourniquet time , knee ROM , Knee Society scores , postoperative complications , use of antibiotics , and any subsequent surgical interventions .
METHODS	These outcomes were assessed at each visit except for Knee Society scores which were collected at the 12-week and 1-year evaluations .
METHODS	All patients completed followups up to the final evaluation at 1year .
RESULTS	Mean wound closure time was 4.7 minutes less using barbed sutures ( SD ,2.8 ; 95 % CI , -5.5 to -3.7 ; p < 0.001 ) , average 16.1 ( SD ,2.2 ) versus 11.4 ( SD ,2.2 ) minutes for the standard versus barbed suture types , respectively .
RESULTS	Overall tourniquet time was not different at 78.7 minutes ( SD ,11.1 minutes ) versus 74.9 minutes ( SD ,10.1 minutes ) , respectively ( p > 0.1 ) .
RESULTS	There were no intraoperative clinical issues , such as provider or patient injury , using either suture .
RESULTS	There were no needle disengagements or suture breakages with barbed-suture closure ; five episodes of premature disengagement of the suture from the needle and three suture breakages were observed with standard closures ( p < 0.005 ) .
RESULTS	There were no postoperative wound dehiscences or disruptions of the arthrotomy closure with either closure technique .
RESULTS	Final ROM was not different with the numbers available ( barbed-suture group mean , 126.76.9 SD vs standard-suture group mean , 125.67.0 SD ; p = 0.4 , 95 % CI , -3.77 to 1.73 ) between patient groups at 1year .
RESULTS	There were no differences with the numbers available in 1-year Knee Society knee scores ( barbed mean , 92.86.69 SD vs standard mean , 93.36.2 SD ; p = 0.6 , 95 % CI , -1.97 to 3.36 ) .
RESULTS	Considering suture material cost against time savings in operating room time , there was a cost savings of mean USD 175 per case when using barbed suture .
CONCLUSIONS	In this randomized controlled trial , I found knotless bidirectional barbed suture to be more efficient in terms of closure time and lower in direct operative cost than conventional suture material , while showing no difference in terms of Knee Society knee scores , ROM , or wound appearance with the numbers available .
CONCLUSIONS	Future studies with larger numbers will be needed to compare overall costs of care and to detect uncommon complications that might arise , although none were observed in this small series .
METHODS	Level I , therapeutic study .

###25138333
OBJECTIVE	Health care systems need effective models to manage chronic diseases like tobacco dependence across transitions in care .
OBJECTIVE	Hospitalizations provide opportunities for smokers to quit , but research suggests that hospital-delivered interventions are effective only if treatment continues after discharge .
OBJECTIVE	To determine whether an intervention to sustain tobacco treatment after hospital discharge increases smoking cessation rates compared with standard care .
METHODS	A randomized clinical trial compared sustained care ( a postdischarge tobacco cessation intervention ) with standard care among 397 hospitalized daily smokers ( mean age , 53 years ; 48 % were males ; 81 % were non-Hispanic whites ) who wanted to quit smoking after discharge and received a tobacco dependence intervention in the hospital ; 92 % of eligible patients and 44 % of screened patients enrolled .
METHODS	The study was conducted from August 2010 through November 2012 at Massachusetts General Hospital .
METHODS	Sustained care participants received automated interactive voice response telephone calls and their choice of free smoking cessation medication ( any type approved by the US Food and Drug Administration ) for up to 90 days .
METHODS	The automated telephone calls promoted cessation , provided medication management , and triaged smokers for additional counseling .
METHODS	Standard care participants received recommendations for postdischarge pharmacotherapy and counseling .
METHODS	The primary outcome was biochemically confirmed past 7-day tobacco abstinence at 6-month follow-up after discharge from the hospital ; secondary outcomes included self-reported tobacco abstinence .
RESULTS	Smokers randomly assigned to sustained care ( n = 198 ) used more counseling and more pharmacotherapy at each follow-up assessment than those assigned to standard care ( n = 199 ) .
RESULTS	Biochemically validated 7-day tobacco abstinence at 6 months was higher with sustained care ( 26 % ) than with standard care ( 15 % ) ( relative risk [ RR ] , 1.71 [ 95 % CI , 1.14-2 .56 ] , P = .009 ; number needed to treat , 9.4 [ 95 % CI , 5.4-35 .5 ] ) .
RESULTS	Using multiple imputation for missing outcomes , the RR for 7-day tobacco abstinence was 1.55 ( 95 % CI , 1.03-2 .21 ; P = .04 ) .
RESULTS	Sustained care also resulted in higher self-reported continuous abstinence rates for 6 months after discharge ( 27 % vs 16 % for standard care ; RR , 1.70 [ 95 % CI , 1.15-2 .51 ] ; P = .007 ) .
CONCLUSIONS	Among hospitalized adult smokers who wanted to quit smoking , a postdischarge intervention providing automated telephone calls and free medication resulted in higher rates of smoking cessation at 6 months compared with a standard recommendation to use counseling and medication after discharge .
CONCLUSIONS	These findings , if replicated , suggest an approach to help achieve sustained smoking cessation after a hospital stay .
BACKGROUND	clinicaltrials.gov Identifier : NCT01177176 .

###25251201
BACKGROUND	There is a high co-occurrence of cocaine and alcohol use disorders , and patients with both of these problems are difficult to treat .
BACKGROUND	There is a reasonable rationale and some empirical data to justify a pilot trial of an injectable , extended-release formulation of naltrexone for treating co-occurring cocaine and alcohol addiction .
METHODS	Eighty cocaine ( n = 80 ) and alcohol dependent , treatment-seeking subjects were randomly assigned to receive either two monthly extended-release injections of naltrexone or two matching placebo injections in an 8-week clinical trial , with weekly medical management plus cognitive behavioral therapy visits .
RESULTS	No differences in reduction in cocaine or alcohol use were observed between the injectable naltrexone and placebo groups during the 8-week trial .
CONCLUSIONS	Injectable extended-release naltrexone , while an ideal method for ensuring medication adherence in these traditionally hard-to-treat patients , did not result in any measurable reduction in cocaine or alcohol use over the course of 8 weeks of treatment .

###25429853
BACKGROUND	Nonalcoholic steatohepatitis ( NASH ) is associated with dyslipidemia and cardiovascular disease ( CVD ) .
OBJECTIVE	To determine the relationship between resolution of NASH and dyslipidemia .
METHODS	Individuals in the Pioglitazone vs. Vitamin E vs. Placebo for the Treatment of Nondiabetic Patients with Nonalcoholic Steatohepatitis ( PIVENS ) trial with paired liver biopsies and fasting lipid levels were included ( N = 222 ) .
METHODS	In the PIVENS trial individuals were randomised to pioglitazone 30 mg , vitamin E 800 IU or placebo for 96 weeks .
METHODS	Change in lipid levels at 96 weeks was compared between those with and without NASH resolution .
RESULTS	Dyslipidemia at baseline was frequent , with low high-density lipoprotein ( HDL ) ( < 40 mg/dL in men or < 50 mg/dL in women ) in 63 % , hypertriglyceridaemia ( 150 mg/dL ) in 46 % , hypercholesterolaemia ( 200 mg/dL ) in 47 % and triglycerides ( TG ) / HDL > 5.0 in 25 % .
RESULTS	Low-density lipoprotein ( LD ) 160 mg/dL was found in 16 % and elevated non-HDL cholesterol ( non-HDL-C ) ( 130 mg/dL ) in 73 % .
RESULTS	HDL increased with NASH resolution but decreased in those without resolution ( 2.9 mg/dL vs. -2.5 mg/dL , P < 0.001 ) .
RESULTS	NASH resolution was associated with significant decreases in TG and TG/HDL ratio compared to those without resolution ( TG : -21.1 vs. -2.3 mg/dL , P = 0.03 and TG/HDL : -0.7 vs. 0.1 , P = 0.003 ) .
RESULTS	Non-HDL-C , LDL and cholesterol decreased over 96 weeks in both groups , but there was no significant difference between groups .
RESULTS	Treatment group did not impact lipids .
CONCLUSIONS	NASH resolution is associated with improvements in TG and HDL but not in other cardiovascular disease risk factors including LDL and non-HDL-C levels .
CONCLUSIONS	Individuals with resolution of NASH may still be at increased risk of cardiovascular disease .
CONCLUSIONS	ClinicalTrials.gov identifier : NCT00063622 .

###25380005
BACKGROUND	Postoperative ileus is the most common complication after ileostomy closure with an increase in morbidity , hospital stay , and health care costs .
OBJECTIVE	The aim of this study is to assess the utility of a new technique for reducing postoperative ileus after protective ileostomy closure .
METHODS	This is a prospective randomized study registered at ClinicalTrials.gov ( NCT01881594 ) .
METHODS	Patients were randomly assigned to undergo either stimulation through the efferent limb of the ileostomy before surgery or nonstimulation before surgery .
METHODS	This study was conducted at the Department of Surgery of the Virgen de la Arrixaca Clinical University Hospital ( Murcia ) .
METHODS	Seventy patients underwent surgery for ileostomy closure .
METHODS	In 35 patients , during the 2 weeks before surgery , daily stimulation of the defunctionalized stomal segment was performed by using a thick solution ( 500 mL of physiological saline associated with 30 g of thickening agent , Nestle Resource , Vevey , Switzerland ) .
METHODS	In the other 35 patients , stimulation was not performed before surgery .
METHODS	The primary outcome was postoperative ileus .
METHODS	The secondary outcomes included time to tolerating a diet and postoperative stay .
RESULTS	Both groups of patients were homogenous for demographic data , characteristics of the first rectal cancer operation , and intersurgery periods .
RESULTS	After ileostomy closure , the stimulated group of patients had an earlier return to oral tolerance ( 1.06 vs 2.57 days ; p = 0.007 ) and passage of flatus or stool ( 1.14 vs 2.85 days ; p < 0.001 ) than the nonstimulated group of patients .
RESULTS	The incidence of postoperative ileus ( 2.85 % vs 20 % ; p = 0.024 ) and hospital stay ( 2.49 vs 4.61 days ; p = 0.002 ) was also lower in the stimulated patients .
CONCLUSIONS	Small numbers of patients means that no definitive statements can be made regarding the effectiveness of this technique .
CONCLUSIONS	Stimulation of the efferent limb of the ileostomy before closure is a safe technique that reduces postoperative ileus and fosters early intestinal transit and oral tolerance with a shorter postoperative hospital stay .

###24909563
OBJECTIVE	To study the relationship between the severity of carpal tunnel syndrome ( CTS ) symptoms and surgery for CTS and the relationship between conservative treatments and surgery for CTS .
METHODS	A secondary analysis of baseline to 6-month data from a randomized controlled trial , which examined the effectiveness of orthosis/stretch combinations on the symptoms of CTS , was conducted for a total of 96 participants with CTS .
METHODS	Participants completed the Carpal Tunnel Questionnaire and posttreatment surveys .
METHODS	Statistical analyses included exploration of correlates of progression to surgery for CTS and logistical regression to examine the association between conservative treatments and CTS symptoms and progression to surgery for CTS .
RESULTS	Twenty-one participants received surgery for their CTS , and 31 participants received 1 or more conservative treatments .
RESULTS	Severity of baseline CTS symptoms and additional treatments were indicators of progression to surgery .
RESULTS	The randomized controlled trial intervention was inversely associated with progression to surgery .
CONCLUSIONS	CTS that does not respond to an initial course of conservative treatment may not improve with additional treatments .
CONCLUSIONS	More than half of the participants who received additional conservative treatment still progressed to surgery .
CONCLUSIONS	Current intervention guidelines for CTS provide limited guidance as to the best methods to efficiently treat CTS .
CONCLUSIONS	CTS is a costly and high-burden disorder , resulting in reduced quality of life .
CONCLUSIONS	Research should examine when and for whom conservative care is an effective choice and the association between conservative care and the eventual need for CTS surgery .

###24424704
OBJECTIVE	Evaluate potential gender effects on efficacy and safety of a buffered zolpidem sublingual tablet ( ZST ) formulation .
METHODS	Post hoc analysis of the pivotal sleep laboratory and outpatient studies , per gender .
RESULTS	In the sleep laboratory study , polysomnography-derived latency to persistent sleep after middle-of-the-night was significantly improved for both genders at both 1.75 mg and 3.5 mg ZST ( females : 15.7 and 8.6 min , respectively , vs. 27.7 min [ placebo ] ; males : 19.0 and 12.7 min vs. 29.0 min [ placebo ] ) with no significant gender differences .
RESULTS	In the outpatient study , subjective sleep onset latency after middle-of-the-night was significantly shorter for both genders treated with ZST 3.5 mg versus placebo over the 4-week average ( females : 37.3 vs. 59.4 min , p < 0.0001 ; males : 38.6 vs. 55.1 min , p0 .01 ) .
RESULTS	There were no gender differences in subjective sleep onset latency after middle-of-the-night awakening .
RESULTS	In the outpatient study , weekly usage of ZST and placebo by both genders declined throughout the study .
RESULTS	Morning alertness following dosing nights improved in both genders , although significant only in females .
RESULTS	In both studies , there were no gender differences in adverse events .
CONCLUSIONS	Time to return to sleep after middle-of-the-night dosing with ZST improved in both genders , with no gender differences in efficacy and safety .

###25166023
BACKGROUND	This randomized , double-blind , placebo-controlled , single and multiple ascending-dose study evaluated the pharmacodynamic effects and safety/tolerability of canagliflozin , a sodium glucose co-transporter 2 inhibitor , in patients with type 2 diabetes .
METHODS	Patients ( N = 116 ) discontinued their antihyperglycemic medications 2 weeks before randomization .
METHODS	Patients received canagliflozin 30 , 100 , 200 , or 400 mg once daily or 300 mg twice daily , or placebo at 2 study centers in the United States and Germany , or canagliflozin 30 mg once daily or placebo at 1 study center in Korea , while maintaining an isocaloric diet for 2 weeks .
METHODS	On Days -1 , 1 , and 16 , urinary glucose excretion ( UGE ) , plasma glucose ( PG ) , fasting PG ( FPG ) , and insulin were measured .
METHODS	The renal threshold for glucose ( RTG ) was calculated from UGE , PG , and estimated glomerular filtration rate .
METHODS	Safety was evaluated based on adverse event ( AE ) reports , vital signs , electrocardiograms , clinical laboratory tests , and physical examinations .
RESULTS	Canagliflozin increased UGE dose-dependently ( 80-120 g/day with canagliflozin 100 mg ) , with increases maintained over the 14-day dosing period with each dose .
RESULTS	Canagliflozin dose-dependently decreased RTG , with maximal reductions to 4-5 mM ( 72-90 mg/dL ) .
RESULTS	Canagliflozin also reduced FPG and 24-hour mean PG ; glucose reductions were seen on Day 1 and maintained over 2 weeks .
RESULTS	Plasma insulin reductions with canagliflozin were consistent with observed PG reductions .
RESULTS	Canagliflozin also reduced body weight .
RESULTS	AEs were transient , mild to moderate in intensity , and balanced across groups ; 1 canagliflozin-treated female reported an episode of vaginal candidiasis .
RESULTS	Canagliflozin did not cause hypoglycemia , consistent with the RTG values remaining above the hypoglycemia threshold .
RESULTS	At Day 16 , there were no clinically meaningful changes in urine volume , urine electrolyte excretion , renal function , or routine laboratory test values .
CONCLUSIONS	Canagliflozin increased UGE and decreased RTG , leading to reductions in PG , insulin , and body weight , and was generally well tolerated in patients with type 2 diabetes .
BACKGROUND	ClinicalTrials.gov NCT00963768 .

###25375395
BACKGROUND	Patient perceptions of financial burden and rates of cost-related nonadherence are high among individuals with asthma across the socioeconomic spectrum .
BACKGROUND	Little is known about preferences and frequency of physician-patient discussions about cost/affordability among individuals managing respiratory conditions .
OBJECTIVE	To examine who has a preference to discuss the cost of their asthma care with their physician , how often physician-patient communication about cost/affordability actually is occurring , and what clinical and demographic characteristics of patients are predictive of communication .
METHODS	Data came from 422 African American adult women with asthma who were asked about communication preferences and practices around cost and affordability with their physician .
METHODS	Data were analyzed using descriptive statistics and multiple variable logistic regression models .
RESULTS	Fifty-two percent ( n = 219 ) of this sample perceived financial burden .
RESULTS	Seventy-two percent ( n = 300 ) reported a preference to discuss cost with their health-care provider .
RESULTS	Thirty-nine percent ( n = 163 ) reported actually having a conversation with their physician about cost .
RESULTS	Among the 61 % who reported no discussion , 40 % ( n = 103 ) reported financial burden , and 55 % ( n = 140 ) reported a preference for discussion .
RESULTS	Lower household income ( P < 0.001 ) , perception of financial burden ( P < 0.001 ) , and higher out-of-pocket expenses for medicines ( P < 0.05 ) were significantly predictive of greater preference to communicate about cost/affordability with the doctor when adjusted for clinical and demographic characteristics .
RESULTS	Perception of financial burden ( P < 0.001 ) , preference to discuss affordability ( P < 0.001 ) , and greater number of chronic conditions ( P < 0.001 ) were significantly predictive of greater likelihood of communication about cost/affordability with the doctor when adjusted for clinical and demographic characteristics .
RESULTS	Bivariate analyses revealed that patients who reported a discussion of cost were more likely to report worse asthma control and lower asthma-related quality of life .
CONCLUSIONS	An imbalance is evident between patients who would like to discuss cost with their doctor and those who actually do .
CONCLUSIONS	Patients are interested in low-cost options and a venue for addressing their concerns with a care provider ; therefore , a greater understanding is needed in how to effectively and efficiently integrate these conversations and viable solutions into the delivery of health care .
CONCLUSIONS	Additional research is necessary to determine whether communication about the cost of therapy is associated with health outcomes .

###25487708
BACKGROUND	In colorectal cancer ( CRC ) , unresectable liver metastases are linked to poor prognosis .
BACKGROUND	Systemic chemotherapy with regimens such as FOLFOX ( combination of infusional 5-fluorouracil , leucovorin and oxaliplatin ) is the standard first-line treatment .
BACKGROUND	The SIRFLOX trial was designed to assess the efficacy and safety of combining FOLFOX-based chemotherapy with Selective Internal Radiation Therapy ( SIRT or radioembolisation ) using yttrium-90 resin microspheres ( SIR-SpheresR ; Sirtex Medical Limited , North Sydney , Australia ) .
METHODS	SIRFLOX is a randomised , multicentre trial of mFOLFOX6 chemotherapy + / - SIRT as first-line treatment of patients with liver-only or liver-predominant metastatic CRC ( mCRC ) .
METHODS	The trial aims to recruit adult chemotherapy-naive patients with proven liver metastases with or without limited extra-hepatic disease , a life expectancy of > = 3 months and a WHO performance status of 0-1 .
METHODS	Patients will be randomised to receive either mFOLFOX6 or SIRT + mFOLFOX6 ( with a reduced dose of oxaliplatin in cycles 1-3 following SIRT ) .
METHODS	Patients in both arms can receive bevacizumab at investigator discretion .
METHODS	Protocol chemotherapy will continue until there is unacceptable toxicity , evidence of tumour progression , complete surgical resection or ablation of cancerous lesions , or the patient requests an end to treatment .
METHODS	The primary endpoint of the SIRFLOX trial is progression-free survival ( PFS ) .
METHODS	Secondary endpoints include : PFS in the liver ; tumour response rate ( liver and any site ) ; site of tumour progression ; health-related quality of life ; toxicity and safety ; liver resection rate ; and overall survival .
METHODS	Assuming an increase in the median PFS from 9.4 months to 12.5 months with the addition of SIRT to mFOLFOX6 , recruiting > = 450 patients will be sufficient for 80 % power and 95 % confidence .
CONCLUSIONS	The SIRFLOX trial will establish the potential role of SIRT + standard systemic chemotherapy in the first-line management of mCRC with non-resectable liver metastases .
BACKGROUND	SIRFLOX ClinicalTrials.gov identifier : NCT00724503 .
BACKGROUND	Registered 25 July 2008 .

###25220861
OBJECTIVE	The authors compared the effectiveness of fluoxetine and desipramine treatment in a prospective double-blind pharmacogenetics study in first-generation Mexican Americans and examined the role of whole-exome functional gene variations in the patients ' antidepressant response .
METHODS	A total of 232 Mexican Americans who met DSM-IV criteria for major depressive disorder were randomly assigned to receive 8 weeks of double-blind treatment with desipramine ( 50-200 mg/day ) or fluoxetine ( 10-40 mg/day ) after a 1-week placebo lead-in period .
METHODS	Outcome measures included the Hamilton Depression Rating Scale ( HAM-D ) , the Hamilton Anxiety Rating Scale , and the Beck Depression Inventory .
METHODS	At week 8 , whole-exome genotyping data were obtained for 36 participants who remitted and 29 who did not respond to treatment .
RESULTS	Compared with desipramine treatment , fluoxetine treatment was associated with a greater reduction in HAM-D score , higher response and remission rates , shorter time to response and remission , and lower incidences of anticholinergic and cardiovascular side effects .
RESULTS	Pharmacogenetics analysis showed that exm-rs1321744 achieved exome-wide significance for treatment remission .
RESULTS	This variant is located in a brain methylated DNA immunoprecipitation sequencing site , which suggests that it may be involved in epigenetic regulation of neuronal gene expression .
RESULTS	This and two other common gene variants provided a highly accurate cross-validated predictive model for treatment remission of major depression ( receiver operating characteristic integral = 0.95 ) .
CONCLUSIONS	Compared with desipramine , fluoxetine treatment showed a more rapid reduction of HAM-D score and a lower incidence of side effects in a population comprising primarily first-generation Mexican Americans with major depression .
CONCLUSIONS	This study 's pharmacogenetics approach strongly implicates the role of functional variants in antidepressant treatment response .

###24267860
BACKGROUND	The txt2stop trial demonstrated that smoking-cessation support delivered by text message doubles biochemically verified abstinence at 6 months .
BACKGROUND	There was no significant heterogeneity in any of the pre-specified subgroups .
OBJECTIVE	To explore participants ' experiences of the txt2stop intervention via a qualitative study using telephone interviews .
METHODS	Qualitative telephone interviews in the community .
METHODS	Thematic content analysis of 1283 feedback forms was conducted to develop a topic guide for 25 telephone interviews .
METHODS	Key themes were identified and described .
METHODS	Any differences in the experiences of those who did , and did not , successfully quit were specifically explored .
RESULTS	Participants liked the fact that smoking-cessation support delivered by text message was convenient , easy to access , and chemical free .
RESULTS	They reported that the intervention was a reminder that they were quitting and why , provided emotional support , was a reminder of the physical benefits of stopping smoking , and they saved messages so they could refer back to them .
RESULTS	However , the intervention was not helpful for all .
RESULTS	Receiving texts about smoking could also stimulate craving , and the timing , frequency , and duration of messages were not optimal for some participants .
RESULTS	Those who did not quit reported that additional factors influenced them , such as periods of stress or social events , or reported that they had been unable to cope with the physical effects of withdrawal , and combining text-message support with medication could help with this .
CONCLUSIONS	Although the intervention did stimulate craving in some participants at some times , recipients reported that it also provided emotional support and reinforcement at temporally appropriate moments .
CONCLUSIONS	It was successful at helping people to quit smoking but could be used together with other forms of smoking-cessation support .

###24238769
OBJECTIVE	The administration of 2-agonists to patients with airways obstruction often results in transient decrease in PaO2 despite concomitant bronchodilation .
OBJECTIVE	This effect is potentially dangerous for patients suffering from acute exacerbation of COPD ( AECOPD ) .
OBJECTIVE	In this study , we investigated the effect of indacaterol 150g and 300g on the arterial blood gas tensions of hospitalised patients with AECOPD .
METHODS	We explored the acute effects on arterial blood gases and spirometry of two doses of indacaterol Breezhaler ( 150 and 300g ) in 12 patients hospitalised because of an AECOPD in 2 non-consecutive days under open-label , randomized , crossover conditions , with blind evaluation .
METHODS	Blood specimens were taken just before the inhalation and at 15 , 30 , 60 , 120 , 240 and 360min after inhalation of each treatment , and spirometry was performed at the same time points .
RESULTS	Both doses of indacaterol did not cause significant changes in blood gases , although some patients with relatively well-preserved PaO2 presented transient episodes of oxygen desaturation that normalize spontaneously in a very short time .
RESULTS	Moreover , they induced a significant mean increase in FEV1 and FVC , although the improvement caused by indacaterol 300g was larger .
CONCLUSIONS	Indacaterol up to 300g is a potent bronchodilator that may induce small , transient decrease in PaO2 mainly in patients with relatively well-preserved PaO2 .
CONCLUSIONS	There appeared to be no clinical consequences of these PaO2 abnormalities in patients suffering from AECOPD .

###24636287
OBJECTIVE	To investigate the efficacy profile of entecavir capsule ( ETV ) as a chronic hepatitis B therapy , as compared to lamivudine ( LAM ) .
METHODS	In this multicenter , randomized , double-blind , parallel group evaluation of ETV , 232 subjects were administered a 96-week course of 0.5 mg/day ETV or 100 mg/day LAM .
METHODS	PCR measurement of hepatitis B virus ( HBV ) was conducted throughout the treatment course to determine achievement of complete virologic response ( CVR ; defined as less than 500 copies/ml of HBV DNA ) or experience of virology rebound ( more than 500 copies/ml of HBV DNA after achievement of CVR ) .
RESULTS	After week-48 of treatment , the ETV group showed a higher CVR rate ( 90.3 % vs. LAM : 59.4 % ) and lower virology rebound rate ( 1.9 % vs. LAM : 13.9 % ) .
RESULTS	After week-96 of treatment , the ETV group continued to have a higher CVR rate ( 86.0 % vs. LAM : 71.4 % ) , and virology rebound was experienced by significantly less subjects in the ETV group ( 1.2 % vs. LAM : 11.9 % , P = 0.005 ) .
CONCLUSIONS	ETV therapy can quickly and continuously suppress HBV replication in chronic hepatitis B patients , and has a lower resistance rate than LAM .
CONCLUSIONS	Compared to LAM , ETV may be a superior long-term treatment choice for chronic hepatitis B.

###25545655
BACKGROUND	This study was designed to assess the feasibility of dual closed-loop titration of propofol and remifentanil guided solely by the Bispectral Index ( BIS ) monitor in pediatric and adolescent patients during anesthesia .
METHODS	Children undergoing elective surgery in this single-blind randomized study were allocated into the closed-loop ( auto ) or manual ( manual ) group .
METHODS	Primary outcome was the percentage of time with the BIS in the range 40 to 60 ( BIS40-60 ) .
METHODS	Secondary outcomes were the percentage of deep ( BIS < 40 ) anesthesia and drug consumption .
METHODS	Data are presented as median ( interquartile range ) or number ( % ) .
RESULTS	Twenty-three patients ( 12 [ 10 to 14 ] yr ) were assigned to the auto group and 19 ( 14 [ 7 to 14 ] yr ) to the manual group .
RESULTS	The closed-loop controller was able to provide induction and maintenance for all patients .
RESULTS	The percentage of time with BIS40-60 was greater in the auto group ( 87 % [ 75 to 96 ] vs. 72 % [ 48 to 79 ] ; P = 0.002 ) , with a decrease in the percentage of BIS < 40 ( 7 % [ 2 to 17 ] vs. 21 % [ 11 to 38 ] ; P = 0.002 ) .
RESULTS	Propofol ( 2.4 [ 1.9 to 3.3 ] vs. 1.7 [ 1.2 to 2.8 ] mg/kg ) and remifentanil ( 2.3 [ 2.0 to 3.0 ] vs. 2.5 [ 1.2 to 4.3 ] g/kg ) consumptions were similar in auto versus manual groups during induction , respectively .
RESULTS	During maintenance , propofol consumption ( 8.2 [ 6.0 to 10.2 ] vs. 7.9 [ 7.2 to 9.1 ] mg kg h ; P = 0.89 ) was similar between the two groups , but remifentanil consumption was greater in the auto group ( 0.39 [ 0.22 to 0.60 ] vs. 0.22 [ 0.17 to 0.32 ] g kg min ; P = 0.003 ) .
RESULTS	Perioperative adverse events and length of stay in the postanesthesia care unit were similar .
CONCLUSIONS	Intraoperative automated control of hypnosis and analgesia guided by the BIS is clinically feasible in pediatric and adolescent patients and outperformed skilled manual control .

###25533560
OBJECTIVE	To evaluate the efficacy of two surgical treatments for conjunctivochalasis .
METHODS	Prospective randomized control study .
METHODS	Thirty-three conjunctivochalasis patients ( 33 eyes ) were randomly divided into two groups : simple resection group , and resection and fixation group .
METHODS	The former received simple conjunctival resection , and the latter received conjunctival resection and scleral fixation .
METHODS	Postoperative conjunctiva relaxation , BUT and ocular surface disease index ( OSDI ) points were compared to evaluate the efficacy of the two kinds of surgical methods .
RESULTS	The recurrence rate of conjunctivochalasis was 6/16 in the simple resection group and 1/17 in the resection and fixation group on month 6 after operation , and there was significant difference ( P = 0.039 ) .
RESULTS	In 1 month , 3 months and 6 months postoperatively , the proportion of normal BUT increased respectively in both groups ( simple resection group :8 / 16 , 9/16 , 10/16 ; resection and fixation group :8 / 17 , 10/17 , 11/17 ) compared with that before operation ( simple resection group :3 / 16 ; resection and fixation group :4 / 17 ) .
RESULTS	The difference was statistically significant 6 months after operation compared with that before operation ( simple resection group :P = 0.029 ; resection and fixation group :P = 0.037 ) , but there was no statistical significance between the two groups at each time point postoperatively ( P = 1.00 ) .
RESULTS	OSDI scores were significantly decreased in 6 months after operation in both groups ( simple resection group :7.76 2.42 ; resection and fixation group :7.21 2.39 ) compared with those before operation ( simple resection group :22.35 14.68 ; resection and fixation group :21.83 15.73 ) .
RESULTS	Both of the differences were statistically significant ( simple resection group : t = 6.598 , P < 0.01 ; resection and fixation group : t = 6.603 , P < 0.01 ) , but there was no statistically significant difference between the two groups on month 6 postoperatively ( t = 0.647 , P = 0.537 ) .
CONCLUSIONS	Both conjunctival resection and conjunctival resection with sclera fixation can effectively improve symptoms , but the latter has a lower recurrence rate .

###24645560
BACKGROUND	This paper presents the prevalence of health promotion in workplaces in Poland .
BACKGROUND	It characterises the undertaken ac tions , their rationale and perceived obstacles .
BACKGROUND	It analyses the diversity of these phenomena in the companies of different financial soundness and level of employment .
METHODS	The study was conducted with the use of Computer Assisted Telephone Interview in 2010 on the representative national sample of 1002 workplaces hiring more than 50 employees .
METHODS	The data was compared with the results of the survey conducted in 2006 , with the use of a Paper and Pencil interview on 611 similar companies .
RESULTS	Both studies have shown that 40 % of the companies are concerned about their employees ' health to a greater extent than they are obliged to by the law .
RESULTS	At the same time , more than 80 % of the companies have been introducing various modifications and health-oriented actions without definite health intentions .
RESULTS	Most companies improve their physical working environment , organise/sponsor medical services , sports activities and try to reduce stress and smoking .
RESULTS	Managers have increased their awareness of business benefits re ceived from health promotion .
RESULTS	They have displayed more personal involvement in health promotion implementation .
RESULTS	The most often mentioned obstacles have included limited financial resources and little interest of employees regarding health issues .
CONCLUSIONS	The larger and wealthier the company is , the more often health promotion in the company is performed .
CONCLUSIONS	Such a company is more convinced about an increase in its activities and has more reasons to care about health .
CONCLUSIONS	Unequal access to health promotion of wor kers in different companies may contribute to an increase in health inequalities in the working population .

###24628747
OBJECTIVE	The objective was to test the hypothesis that hydrocodone/acetaminophen ( Vicodin [ 5/500 ] ) provides more efficacious analgesia than codeine/acetaminophen ( Tylenol # 3 [ 30/300 ] ) in patients discharged from the emergency department ( ED ) .
OBJECTIVE	Both are currently Drug Enforcement Administration ( DEA ) Schedule III narcotics .
METHODS	This was a prospective , randomized , double-blind , clinical trial of patients with acute extremity pain who were discharged home from the ED , comparing a 3-day supply of oral hydrocodone/acetaminophen ( 5 mg/500 mg ) to oral codeine/acetaminophen ( 30 mg/300 mg ) .
METHODS	Pain was measured on a valid and reproducible verbal numeric rating scale ( NRS ) ranging from 0 to 10 , and patients were contacted by telephone approximately 24 hours after being discharged .
METHODS	The primary outcome was the between-group difference in improvement in pain at 2 hours following the most recent ingestion of the study drug , relative to the time of phone contact after ED discharge .
METHODS	Secondary outcomes compared side-effect profiles and patient satisfaction .
RESULTS	The median time from ED discharge to follow-up was 26 hours ( interquartile range [ IQR ] = 24 to 39 hours ) .
RESULTS	The mean NRS pain score before the most recent dose of pain medication after ED discharge was 7.6 NRS units for both groups .
RESULTS	The mean decrease in pain scores 2 hours after pain medications were taken were 3.9 NRS units in the hydrocodone/acetaminophen group versus 3.5 NRS units in the codeine/acetaminophen group , for a difference of 0.4 NRS units ( 95 % confidence interval [ CI ] = -0.3 to 1.2 NRS units ) .
RESULTS	No differences were found in side effects or patient satisfaction .
CONCLUSIONS	Both medications decreased NRS pain scores by approximately 50 % .
CONCLUSIONS	However , the oral hydrocodone/acetaminophen failed to provide clinically or statistically superior pain relief compared to oral codeine/acetaminophen when prescribed to patients discharged from the ED with acute extremity pain .
CONCLUSIONS	Similarly , there were no clinically or statistically important differences in side-effect profiles or patient satisfaction .
CONCLUSIONS	If the DEA reclassifies hydrocodone as a Schedule II narcotic , as recently recommended by its advisory board , our data suggest that the codeine/acetaminophen may be a clinically reasonable Schedule III substitute for hydrocodone/acetaminophen at ED discharge .
CONCLUSIONS	These findings should be regarded as tentative and require independent validation in similar and other acute pain models .

###25935098
OBJECTIVE	To demonstrate equivalence of polyquaternium-1-preserved travoprost 0.003 % with benzalkonium chloride-preserved travoprost 0.004 % in patients with open-angle glaucoma or ocular hypertension .
METHODS	Double-masked , randomized , 2-treatment , equivalence clinical trial .
METHODS	setting : Multicenter clinical trial conducted in 60 centers in the United States and Europe .
METHODS	Adult patients with open-angle glaucoma or ocular hypertension .
METHODS	One eye per patient was analyzed .
METHODS	Patients were randomized 1:1 to receive polyquaternium-1-preserved travoprost 0.003 % ( n = 442 ) or benzalkonium chloride-preserved travoprost 0.004 % ( n = 422 ) once daily for 3 months .
METHODS	Mean intraocular pressure ( IOP ) was assessed at 8 AM , 10 AM , and 4 PM at week 2 , week 6 , and month 3 .
METHODS	Supportive outcomes were mean and percent IOP change , percentage of patients achieving IOP < 18 mm Hg or 30 % IOP reduction , and adverse events .
RESULTS	Mean IOP was similar between groups at all study visits ( travoprost 0.003 % range , 17.5-18 .9 mm Hg ; travoprost 0.004 % range , 17.4-19 .0 mm Hg ) .
RESULTS	Mean change ( least squares mean differences , -0.1 to 0.3 mm Hg ; 95 % confidence interval , -0.5 to 0.7 mm Hg ) and percentage change ( travoprost 0.003 % , 28.4 % -30.7 % ; travoprost 0.004 % , 28.5 % -31.0 % ) from baseline were comparable .
RESULTS	The percentages of patients with IOP < 18 mm Hg and 30 % reduction of IOP were also similar .
RESULTS	Hyperemia was the most frequent treatment-related adverse event with both formulations ( travoprost 0.003 % , 11.8 % ; travoprost 0.004 % , 14.5 % ) .
CONCLUSIONS	In patients with open-angle glaucoma or ocular hypertension , polyquaternium-1-preserved travoprost 0.003 % solution provided equivalent IOP-lowering efficacy to that of benzalkonium chloride-preserved travoprost 0.004 % .

###25957542
BACKGROUND	Physical fitness is a fundamental prerequisite for soccer players .
BACKGROUND	Kaempferia parviflora is an herbal plant that has been used in some Asian athletes with the belief that it might prevent fatigue and improve physical fitness .
BACKGROUND	This study aimed to determine the effects of Kaempferia parviflora on the physical fitness of soccer players .
METHODS	Sixty soccer players who routinely trained at a sports school participated in a double-blind placebo-controlled trial and were randomly allocated to the treatment group or the placebo group .
METHODS	The participants in both groups were given either 180 mg of Kaempferia parviflora extract in capsules or a placebo once daily for 12 weeks .
METHODS	Baseline data were collected using the following 6 tests of physical performance : a sit-and-reach test , a hand grip strength test , a back-and-leg strength test , a 40-yard technical test , a 50-metre sprint test , and a cardiorespiratory fitness test .
METHODS	All of the tests were performed every 4 weeks throughout the 12-week study period .
RESULTS	The study showed that after treatment with Kaempferia parviflora , the right-hand grip strength was significantly increased at weeks 4 , 8 , and 12 .
RESULTS	The left-hand grip strength was significantly increased at week 8 .
RESULTS	However , the back-and-leg strength , the 40-yard technical test , the sit-and-reach test , the 50-metre sprint test , and the cardiorespiratory fitness test results of the treatment group were not significantly different from those of the placebo group .
CONCLUSIONS	Taking Kaempferia parviflora supplements for 12 weeks may significantly enhance some physical fitness components in soccer players .

###24952863
BACKGROUND	To further explore the impact of smoking on antiplatelet activity and treatment response , we evaluated time-dependent relationships between smoking status with on-treatment platelet reactivity and clinical outcomes for prasugrel vs. clopidogrel in patients with acute coronary syndromes managed medically without revascularization .
RESULTS	A total of 7062 patients aged < 75 years from the primary TRILOGY ACS cohort randomized to prasugrel vs. clopidogrel were evaluated through 30 months by baseline and time-dependent smoking status with adjusted proportional-hazards models .
RESULTS	A total of 1994 participants ( 28 % ) [ corrected ] were included in a platelet function sub-study evaluating serial P2Y12 reaction unit ( PRU ) measurements .
RESULTS	Current smokers ( n = 1566 [ 22 % ] ) at baseline had fewer comorbidities compared with non-smokers ; nearly half quit smoking during follow-up .
RESULTS	Although median on-treatment PRU values were lower with prasugrel vs. clopidogrel , persistent smokers had lower serial PRU values in both treatment groups compared with non-smokers , with no differential interaction of treatment response by smoking status .
RESULTS	The frequency of cardiovascular death , myocardial infarction , or stroke in current smokers was significantly lower with prasugrel ( 11.7 % ) vs. clopidogrel ( 18.6 % ) , but there was no difference in non-smokers ( 13.8 % vs. 13.7 % ) , with significant interaction between treatment and baseline smoking status ( P = .0002 ) .
RESULTS	Bleeding events occurred more frequently in prasugrel-treated patients with no significant interaction between treatment and baseline smoking status .
CONCLUSIONS	Among medically managed ACS patients < 75 years of age , the risk of ischemic outcomes was significantly reduced with prasugrel vs. clopidogrel among smokers vs. non-smokers .
CONCLUSIONS	No interaction between on-treatment platelet reactivity and smoking status was found .

###25088437
BACKGROUND	Hyperglycaemia could substantially increase the risk of ischaemic heart disease in patients with type 2 diabetes .
BACKGROUND	We investigated whether intensive lowering of glucose concentrations affects risk .
METHODS	We assessed 10,251 adults aged 40-79 years with established type 2 diabetes , mean glycated haemoglobin A1c ( HbA1c ) concentration of 67 mmol/mol ( 83 % ) , and risk factors for ischaemic heart disease enrolled in the ACCORD trial .
METHODS	Participants were assigned to intensive or standard therapy ( target HbA1c less than 42 or 53-63 mmol/mol [ less than 60 % or 70-79 % ] , respectively ) .
METHODS	We assessed fatal or non-fatal myocardial infarction , coronary revascularisation , unstable angina , and new angina during active treatment ( mean 37 years ) plus a further mean 12 years .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00000620 .
RESULTS	Myocardial infarction was less frequent in the intensive than in the standard therapy group during active treatment ( hazard ratio [ HR ] 080 , 95 % CI 067-096 ; p = 0015 ) and overall ( 084 , 072-097 ; p = 002 ) .
RESULTS	Findings were similar for combined myocardial infarction , coronary revascularisation , and unstable angina ( active treatment HR 089 , 95 % CI 079-099 , overall 087 079-096 ) and for coronary revascularisation alone ( 084 , 075-094 ) and unstable angina alone ( 081 , 067-097 ) during full follow-up .
RESULTS	With lowest achieved HbA1C concentrations included as a time-dependent covariate , all hazards became non-significant .
CONCLUSIONS	Raised glucose concentration is a modifiable risk factor for ischaemic heart disease in middle-aged people with type 2 diabetes and other cardiovascular risk factors .
BACKGROUND	National Heart , Lung , and Blood Institute , National Institute of Diabetes and Digestive and Kidney Diseases , National Institute on Aging , National Eye Intitute , and Centers for Disease Control and Prevention .

###24650860
BACKGROUND	Different studies have reported the effectiveness of Web-based computer-tailored lifestyle interventions , but economic evaluations of these interventions are scarce .
OBJECTIVE	The objective was to assess the cost-effectiveness and cost-utility of a sequential and a simultaneous Web-based computer-tailored lifestyle intervention for adults compared to a control group .
METHODS	The economic evaluation , conducted from a societal perspective , was part of a 2-year randomized controlled trial including 3 study groups .
METHODS	All groups received personalized health risk appraisals based on the guidelines for physical activity , fruit intake , vegetable intake , alcohol consumption , and smoking .
METHODS	Additionally , respondents in the sequential condition received personal advice about one lifestyle behavior in the first year and a second behavior in the second year ; respondents in the simultaneous condition received personal advice about all unhealthy behaviors in both years .
METHODS	During a period of 24 months , health care use , medication use , absenteeism from work , and quality of life ( EQ-5D-3L ) were assessed every 3 months using Web-based questionnaires .
METHODS	Demographics were assessed at baseline , and lifestyle behaviors were assessed at both baseline and after 24 months .
METHODS	Cost-effectiveness and cost-utility analyses were performed based on the outcome measures lifestyle factor ( the number of guidelines respondents adhered to ) and quality of life , respectively .
METHODS	We accounted for uncertainty by using bootstrapping techniques and sensitivity analyses .
RESULTS	A total of 1733 respondents were included in the analyses .
RESULTS	From a willingness to pay of 4594 per additional guideline met , the sequential intervention ( n = 552 ) was likely to be the most cost-effective , whereas from a willingness to pay of 10,850 , the simultaneous intervention ( n = 517 ) was likely to be most cost-effective .
RESULTS	The control condition ( n = 664 ) appeared to be preferred with regard to quality of life .
CONCLUSIONS	Both the sequential and the simultaneous lifestyle interventions were likely to be cost-effective when it concerned the lifestyle factor , whereas the control condition was when it concerned quality of life .
CONCLUSIONS	However , there is no accepted cutoff point for the willingness to pay per gain in lifestyle behaviors , making it impossible to draw firm conclusions .
CONCLUSIONS	Further economic evaluations of lifestyle interventions are needed .
BACKGROUND	Dutch Trial Register NTR2168 ; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2168 ( Archived by WebCite at http://www.webcitation.org/6MbUqttYB ) .

###25512099
OBJECTIVE	The primary objective of this trial was to demonstrate , based on the estimated glomerular filtration rate ( eGFR ) , superior renal function at month 12 after conversion of maintenance kidney transplant patients from calcineurin inhibitor ( CNI ) therapy to everolimus , compared to continuing a standard CNI regimen .
METHODS	APOLLO was an open-label , 12-month , prospective , multicenter study in which 93 maintenance kidney transplant patients were randomized to convert from CNI to everolimus ( n = 46 ) or remain on standard CNI-based immunosuppression ( n = 47 ) .
METHODS	The primary efficacy variable was eGFR ( Nankivell formula ) 12 months after randomization .
METHODS	The study was terminated prematurely due to slow recruitment and was thus underpowered .
RESULTS	Mean time post-transplant was 83.5 months with everolimus and 70.1 months with CNI .
RESULTS	Adjusted values for eGFR ( Nankivell ) at month 12 were 61.6 ( 95 % CI 58.1 , 65.1 ) mL / min/1 .73 m with everolimus and 58.8 ( 95 % CI 55.2 , 62.3 ) mL/min/1 .73 m with CNI , a difference of 2.8 ( 95 % CI -1.0 , 6.7 ) mL / min/1 .73 m ( p = 0.145 ) i.e. , the primary objective was not met .
RESULTS	Using the modification of diet in renal disease ( MDRD ) formula , adjusted eGFR at month 12 was significantly higher with everolimus ( p = 0.030 ) .
RESULTS	In the subpopulation who remained on the study drug ( n = 52 ) , the difference in the adjusted change from randomization was 6.6 ( 95 % CI 1.5 , 11.6 ) mL/min/1 .73 m ( p = 0.013 ) in favor of everolimus .
RESULTS	There was no biopsyproven acute rejection and no graft losses .
RESULTS	Adverse events led to discontinuation of everolimus and CNI in 32.6 % and 10.6 % of patients , respectively .
CONCLUSIONS	Conversion from CNI to everolimus to preserve renal function can be considered several years after kidney transplantation and does not compromise immunosuppressive efficacy .

###24770616
BACKGROUND	We evaluated whether remote ischemic postconditioning ( RiPoC ) could improve initial graft function in living donor kidney transplantation ( KT ) .
METHODS	Patients undergoing living donor KT were randomly assigned to either RiPoC ( n = 30 ) or control group ( n = 30 ) .
METHODS	Immediately after reperfusion in the RiPoC group , three cycles of ischemia and reperfusion , lasting 5 min each , were performed on one upper limb .
METHODS	Renal function was assessed before surgery , 2 hr after surgery , and at 12-hr intervals for 96 hr postsurgery by measuring serum creatinine ( sCr ) and the estimated glomerular filtration rate ( eGFR ) .
METHODS	Urine output and urine creatinine were assessed until postoperative day 7 , and hospital stay and complication rates were compared .
RESULTS	The time for sCr to reach 50 % of its preoperative level was significantly shorter in the RiPoC group than in the control group [ 12 ( 12-24 ) hr for RiPoC vs. 24 ( 21-36 ) hr for the control , P = 0.005 ] .
RESULTS	The number of patients whose sCr was reduced by 50 % within 24 hr was significantly greater in the RiPoC group than in the control group [ n = 26 ( 87 % ) in RiPoC vs. n = 18 ( 60 % ) in control , P = 0.020 ] .
RESULTS	However , there were no differences in sCr and eGFR thereafter , the incidence of graft dysfunction or complication rates between groups .
CONCLUSIONS	In this study , RiPoC appeared to hasten the recovery of graft function within 24 hr but did not affect the graft function thereafter .
CONCLUSIONS	However , considering most recipients had immediate graft function , further studies with deceased donors or studies powered to detect a smaller difference are needed .

###24969229
BACKGROUND	Conjugated linoleic acid ( CLA ) , a C18 fatty acid with conjugated double bonds , has been shown to serve as a powerful anti-obesity agent by several research groups , although the precise mechanism remains elusive .
BACKGROUND	Previous studies showed that CLA induced apoptosis in 3T3-L1 cells and in mice .
BACKGROUND	The aim of this research was to clarify the role of CLA in adipocyte apoptosis in pigs , a relevant model for obesity research .
RESULTS	Our results clearly show that back fat deposition of CLA-fed pigs was significantly lower than that of pigs in the control group .
RESULTS	Moreover , some typical apoptotic cells were observed among the adipocytes of CLA-fed pigs .
RESULTS	Furthermore , the CLA-fed pigs had reduced expression of the anti-apoptosis factor Bcl-2 and increased expression of the pro-apoptosis factors Bax and P53 .
RESULTS	Subsequently , increased cytochrome C was released from the mitochondria to the endochylema , and the caspase cascade was activated , resulting in cellular apoptosis .
RESULTS	These results are consistent with the effects of Bcl-2 and Bax in regulating CLA-induced adipocyte apoptosis via the mitochondrial signaling pathway .
RESULTS	However , the increased expression of tumor necrosis factor ( TNF ) - and its receptor TNFR indicate that the effect of CLA might partly be through the death receptor signaling pathway in adipose cells .
CONCLUSIONS	Our study has demonstrated that CLA reduces pig body fat deposition , an outcome that is partly meditated by apoptosis of adipose cells , and that both the mitochondrial pathway and the death receptor pathway are involved in this effect .

###25168918
BACKGROUND	Despite administration of annual influenza vaccination , influenza-associated complications in transplant recipients continue to be an important cause of hospitalization and death .
BACKGROUND	Although influenza vaccination has been proven to be the most effective measure to reduce influenza infection after transplantation , transplant recipients are still vulnerable to influenza infections , with lower serological responses to vaccination compared to the general population .
BACKGROUND	In order to assess the efficacy and safety of an alternative immunization scheme for solid organ transplant recipients , the TRANSGRIPE1-2 Study Group aimed to test a booster dose administration 5 weeks after the standard vaccination .
BACKGROUND	The primary objective of this trial was to compare short-term and long-term neutralizing antibody immunogenicity of a booster dose of influenza vaccination to the standard single-dose immunization scheme .
BACKGROUND	Secondary objectives included the evaluation of the efficacy and/or safety , cellular immune response , incidence of influenza infection , graft rejection , retransplant and mortality rates .
METHODS	This phase III , randomized , controlled , open-label clinical trial was conducted between October 2012 and December 2013 in 12 Spanish public referral hospitals .
METHODS	Solid organ transplant recipients ( liver , kidney , heart or lung ) , older than 16 years of age more than 30 days after transplantation were eligible to participate .
METHODS	Patients ( N = 514 ) were stratified 1:1 by center , type of organ and time after transplantation and who either received the standard single dose ( n = 257 ) or were treated according to a novel influenza vaccination schedule comprising the administration of a booster dose 5 weeks after standard vaccination ( n = 254 ) .
METHODS	Seroconversion rates were measured as a determinant of protection against influenza ( main outcome ) .
METHODS	Efficacy and safety outcomes were followed until 1 year after influenza vaccination with assessment of short-term ( 0 , 5 , 10 and 15 weeks ) and long-term ( 12 months ) results .
METHODS	Intention-to-treat , per-protocol and safety analyses will be performed .
CONCLUSIONS	This trial will increase knowledge about the safety and efficacy of a booster dose of influenza vaccine in solid organ transplant recipients .
CONCLUSIONS	At the time the manuscript was submitted for publication , trial recruitment was closed with a total of 499 participants included during a 2-month period ( within the seasonal influenza vaccination campaign ) .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01761435 ( registered 13 December 2012 ) .
BACKGROUND	EudraCT Identifier : 2011-003243-21 ( registered 4 July 2011 ) .

###24299621
BACKGROUND	This study investigates the reliability of muscle performance tests using cost - and time-effective methods similar to those used in clinical practice .
BACKGROUND	When conducting reliability studies , great effort goes into standardising test procedures to facilitate a stable outcome .
BACKGROUND	Therefore , several test trials are often performed .
BACKGROUND	However , when muscle performance tests are applied in the clinical setting , clinicians often only conduct a muscle performance test once as repeated testing may produce fatigue and pain , thus variation in test results .
BACKGROUND	We aimed to investigate whether cervical muscle performance tests , which have shown promising psychometric properties , would remain reliable when examined under conditions similar to those of daily clinical practice .
METHODS	The intra-rater ( between-day ) and inter-rater ( within-day ) reliability was assessed for five cervical muscle performance tests in patients with ( n = 33 ) and without neck pain ( n = 30 ) .
METHODS	The five tests were joint position error , the cranio-cervical flexion test , the neck flexor muscle endurance test performed in supine and in a 45-upright position and a new neck extensor test .
RESULTS	Intra-rater reliability ranged from moderate to almost perfect agreement for joint position error ( ICC0.48-0 .82 ) , the cranio-cervical flexion test ( ICC0 .69 ) , the neck flexor muscle endurance test performed in supine ( ICC0 .68 ) and in a 45-upright position ( ICC0 .41 ) with the exception of a new test ( neck extensor test ) , which ranged from slight to moderate agreement ( ICC = 0.14-0 .41 ) .
RESULTS	Likewise , inter-rater reliability ranged from moderate to almost perfect agreement for joint position error ( ICC0.51-0 .75 ) , the cranio-cervical flexion test ( ICC0 .85 ) , the neck flexor muscle endurance test performed in supine ( ICC0 .70 ) and in a 45-upright position ( ICC0 .56 ) .
RESULTS	However , only slight to fair agreement was found for the neck extensor test ( ICC = 0.19-0 .25 ) .
CONCLUSIONS	Intra - and inter-rater reliability ranged from moderate to almost perfect agreement with the exception of a new test ( neck extensor test ) , which ranged from slight to moderate agreement .
CONCLUSIONS	The significant variability observed suggests that tests like the neck extensor test and the neck flexor muscle endurance test performed in a 45-upright position are too unstable to be used when evaluating neck muscle performance .

###26016363
OBJECTIVE	To explore the mechanisms involved in the ligustrazine alleviation of the pulmonary artery hypertension ( PAH ) in patients of chronic obstructive pulmonary disease ( COPD ) associated with chronic cor pulmonale ( CCP ) during exacerbation .
METHODS	Seventy patients of COPD and CCP with acute exacerbation were randomly and equally divided into control group and treatment group .
METHODS	The control group received standard treatment with antibiotics , antiasthmatic and expectorant medications , and oxygenation ; and the ligustrazine treatment group received ligustrazine treatment ( 80 mg/d ; i.v. ; for 2 weeks ) in addition to the standard treatment .
METHODS	Before and at the end of 2 week treatment , the clinic responses of the two regimens were evaluated , plasma levels of endothelin-1 ( ET-1 ) and nitric oxide ( NO ) were determined ; arterial oxygen partial pressure ( PaO2 , mean pulmonary arterial pressure ( mPAP ) , outflow tract of right ventricle ( RVOT ) , and internal diameter of right ventricle ( RV ) were measured .
RESULTS	Good clinic benefits were achieved in both the standard and ligustrazine regimens , plasma level of ET-1 , values of mPAP , RV and RVOT decreased significantly , plasma level of NO and PaO2 values decreased ( all P < 0.01 vs pre-treatment to all parameters ) .
RESULTS	Compared with the control group , ligustrazine greatly enhanced the clinic efficacy from 77.1 % to 97.1 % ( P < 0.05 ) , and also resulted in more significant changes of all these parameters ( P < 0.01 vs control group for all parameters ) .
RESULTS	For both groups , the levels of plasma ET-1 were positively correlated with values of mPAP , RVOT , and RV ( r = 0.710 , 0.853 , and 0.766 , respectively , all P = 0.000 ) , and negatively correlated with plasma NO and PaO2 ( r = - 0.823 , and - 0.752 , respectively , all P = 0.000 ) .
CONCLUSIONS	Ligustrazine is effective in treating pulmonary artery hypertension during acute exacerbation of COPD and CCP in patients from the plateau area .
CONCLUSIONS	The observed changes in the plasma levels of NO and ET-1 in response to ligustrazine treatment suggest that ligustrazine may act through the selective effect on pulmonary blood vessels to enhance the synthesis and release of NO and suppress those of ET-1 from lung vascular endothelial cells , thus reducing pulmonary artery pressure and decreasing pulmonary arterial hypertension .

###26460661
BACKGROUND	In patients with mild gallstone pancreatitis , cholecystectomy during the same hospital admission might reduce the risk of recurrent gallstone-related complications , compared with the more commonly used strategy of interval cholecystectomy .
BACKGROUND	However , evidence to support same-admission cholecystectomy is poor , and concerns exist about an increased risk of cholecystectomy-related complications with this approach .
BACKGROUND	In this study , we aimed to compare same-admission and interval cholecystectomy , with the hypothesis that same-admission cholecystectomy would reduce the risk of recurrent gallstone-related complications without increasing the difficulty of surgery .
METHODS	For this multicentre , parallel-group , assessor-masked , randomised controlled superiority trial , inpatients recovering from mild gallstone pancreatitis at 23 hospitals in the Netherlands ( with hospital discharge foreseen within 48 h ) were assessed for eligibility .
METHODS	Adult patients ( aged 18 years ) were eligible for randomisation if they had a serum C-reactive protein concentration less than 100 mg/L , no need for opioid analgesics , and could tolerate a normal oral diet .
METHODS	Patients with American Society of Anesthesiologists ( ASA ) class III physical status who were older than 75 years of age , all ASA class IV patients , those with chronic pancreatitis , and those with ongoing alcohol misuse were excluded .
METHODS	A central study coordinator randomly assigned eligible patients ( 1:1 ) by computer-based randomisation , with varying block sizes of two and four patients , to cholecystectomy within 3 days of randomisation ( same-admission cholecystectomy ) or to discharge and cholecystectomy 25-30 days after randomisation ( interval cholecystectomy ) .
METHODS	Randomisation was stratified by centre and by whether or not endoscopic sphincterotomy had been done .
METHODS	Neither investigators nor participants were masked to group assignment .
METHODS	The primary endpoint was a composite of readmission for recurrent gallstone-related complications ( pancreatitis , cholangitis , cholecystitis , choledocholithiasis needing endoscopic intervention , or gallstone colic ) or mortality within 6 months after randomisation , analysed by intention to treat .
METHODS	The trial was designed to reduce the incidence of the primary endpoint from 8 % in the interval group to 1 % in the same-admission group .
METHODS	Safety endpoints included bile duct leakage and other complications necessitating re-intervention .
METHODS	This trial is registered with Current Controlled Trials , number ISRCTN72764151 , and is complete .
RESULTS	Between Dec 22 , 2010 , and Aug 19 , 2013 , 266 inpatients from 23 hospitals in the Netherlands were randomly assigned to interval cholecystectomy ( n = 137 ) or same-admission cholecystectomy ( n = 129 ) .
RESULTS	One patient from each group was excluded from the final analyses , because of an incorrect diagnosis of pancreatitis in one patient ( in the interval group ) and discontinued follow-up in the other ( in the same-admission group ) .
RESULTS	The primary endpoint occurred in 23 ( 17 % ) of 136 patients in the interval group and in six ( 5 % ) of 128 patients in the same-admission group ( risk ratio 028 , 95 % CI 012-066 ; p = 0002 ) .
RESULTS	Safety endpoints occurred in four patients : one case of bile duct leakage and one case of postoperative bleeding in each group .
RESULTS	All of these were serious adverse events and were judged to be treatment related , but none led to death .
CONCLUSIONS	Compared with interval cholecystectomy , same-admission cholecystectomy reduced the rate of recurrent gallstone-related complications in patients with mild gallstone pancreatitis , with a very low risk of cholecystectomy-related complications .
BACKGROUND	Dutch Digestive Disease Foundation .

###25942341
BACKGROUND	Umbilical Mesenchymal Stem Cells possess immunoregulatory capacities that have been permissive to allogenic transplantation .
BACKGROUND	Recent animal studies have demonstrated histologically that bone marrow - derived mesenchymal stem cells ( MSCs ) may enhance the regeneration of periodontal defects in dogs by differentiating MSCs into cementoblasts , osteoblasts and periodontal fibroblasts .
OBJECTIVE	To compare the clinical efficacy between stem cells in combination with PLA/PGA membrane and subepithelial connective tissue graft ( SCTG ) in the treatment of multiple gingival recession defects .
METHODS	Twenty four patients aged between 20 to 33 years ( mean age 27.41 1.06 years ) with multiple gingival recession defects on labial or buccal surface of the teeth in the aesthetic zone either in maxilla or mandible were treated .
METHODS	The test group was treated using stem cells cultured on bioresorbable PLA/PGA membrane , while control group was treated using SCTG .
METHODS	Following parameters were assessed , Plaque Index ( PI ) , Gingival Bleeding Point Index ( GBI ) , Relative gingival margin level ( RGML ) , Relative attachment level ( RAL ) and Probing pocket depth ( PPD ) Results : In the test group , mean percent defect coverage was 72.43 13.55 % and the predictability was 41.17 % for root coverage i.e 14 of 34 defects , while in the control group , mean percent defect coverage was 82.06 10.99 % and the predictability was 50 % for root coverage i.e 15 of 30 defects .
CONCLUSIONS	Stem cells in combination with bioresorbable PLA/PGA membrane was effective for root coverage resulted in a significant reduction in gingival recession , greater gain in CAL and WKG .
CONCLUSIONS	Stem cells in combination with bioresorbable PLA/PGA membrane resulted in significantly higher CAL gain than SCTG .

###25306234
BACKGROUND	Laparoscopic adhesiolysis is emerging as an alternative for open surgery in adhesive small bowel obstruction .
BACKGROUND	Retrospective studies suggest that laparoscopic approach shortens hospital stay and reduces complications in these patients .
BACKGROUND	However , no prospective , randomized , controlled trials comparing laparoscopy to open surgery have been published .
METHODS	This is a multicenter , prospective , open label , randomized , controlled trial comparing laparoscopic adhesiolysis to open surgery in patients with computed-tomography diagnosed adhesive small bowel obstruction that is not resolving with conservative management .
METHODS	The primary study endpoint is the length of postoperative hospital stay in days.Sample size was estimated based on preliminary retrospective cohort , which suggested that 102 patients would provide 80 % power to detect a difference of 2.5 days in the length of postoperative hospital stay with significance level of 0.05 .
METHODS	Secondary endpoints include passage of stool , commencement of enteral nutrition , 30-day mortality , complications , postoperative pain , and the length of sick leave .
METHODS	Tertiary endpoints consist of the rate of ventral hernia and the recurrence of small bowel obstruction during long-term follow-up .
METHODS	Long-term follow-up by letter or telephone interview will take place at 1 , 5 , and 10 years .
CONCLUSIONS	To the best of our knowledge , this trial is the first one aiming to provide level Ib evidence to assess the use of laparoscopy in the treatment of adhesive small bowel obstruction .
BACKGROUND	ClinicalTrials.gov identifier : NCT01867528 .
BACKGROUND	Date of registration May 26th 2013 .

###24899137
BACKGROUND	The prevalence of childhood obesity and insulin resistance is rising , increasing the risk of diabetes mellitus type 2 .
BACKGROUND	To prevent these complications , lifestyle intervention is the corner stone in treatment .
BACKGROUND	However , long-term efficacy of lifestyle intervention is questionable .
BACKGROUND	In addition to lifestyle intervention , pharmacological treatments have been explored .
BACKGROUND	Metformin has been shown to be moderately effective to reduce BMI in obese adolescents with hyperinsulinemia .
BACKGROUND	However , data on pharmacokinetics and long-term efficacy and safety are lacking as well as an evidence-based dosing regimen for this age group .
BACKGROUND	The primary objective of the METFORMIN study is to determine the effect of adding metformin treatment to lifestyle intervention in reducing BMI in obese adolescents with insulin resistance .
BACKGROUND	In addition , the pharmacokinetics of metformin in obese adolescents will be studied .
METHODS	The METFORMIN study is a multi-centre prospective study that consists of two 18-month phases : a double-blind randomized placebo-controlled trial ( part 1 ) and an open-label follow-up study ( part 2 ) .
METHODS	During part 1 , the participants will be given metformin 1,000 mg or placebo twice daily and will be offered a lifestyle intervention programme ; 144 participants will be included , 72 in each arm .
METHODS	Primary endpoints are reduction in body mass index , insulin resistance , and percentage body fat .
CONCLUSIONS	This study will provide data on short - and long-term efficacy and safety of metformin and on the pharmacokinetics of metformin in obese adolescents .
BACKGROUND	ClinicalTrials.gov number NCT01487993 ; EudraCT nr .
BACKGROUND	2010-023980-17 .
BACKGROUND	Registration date : 06-01-2011 .

###25477073
BACKGROUND	Practicing evidence-based medicine is an important aspect of providing good medical care .
BACKGROUND	Accessing external information through literature searches on computer-based systems can effectively achieve integration in clinical care .
BACKGROUND	We conducted a pilot study using smartphones , tablets , and stationary computers as search devices at the bedside .
BACKGROUND	The objective was to determine possible differences between the various devices and assess students ' internet use habits .
METHODS	In a randomized controlled pilot study , 120 students were divided in three groups .
METHODS	One control group solved clinical problems on a computer and two intervention groups used mobile devices at the bedside .
METHODS	In a questionnaire , students were asked to report their internet use habits as well as their satisfaction with their respective search tool using a 5-point Likert scale .
RESULTS	Of 120 surveys , 94 ( 78.3 % ) complete data sets were analyzed .
RESULTS	The mobility of the tablet ( 3.90 ) and the smartphone ( 4.39 ) was seen as a significant advantage over the computer ( 2.38 , p < .001 ) .
RESULTS	However , for performing an effective literature search at the bedside , the computer ( 3.22 ) was rated superior to both tablet computers ( 2.13 ) and smartphones ( 1.68 ) .
RESULTS	No significant differences were detected between tablets and smartphones except satisfaction with screen size ( tablet 4.10 , smartphone 2.00 , p < .001 ) .
CONCLUSIONS	Using a mobile device at the bedside to perform an extensive search is not suitable for students who prefer using computers .
CONCLUSIONS	However , mobility is regarded as a substantial advantage , and therefore future applications might facilitate quick and simple searches at the bedside .

###25332325
BACKGROUND	Isoflavone supplements , consumed by women experiencing menopausal symptoms , are suggested to have positive effects on menopause-related adiposity and cardiovascular disease risk profile , but discussions about their safety are still ongoing .
OBJECTIVE	The objective was to study the effects of an 8-wk consumption of 2 different isoflavone supplements compared with placebo on whole-genome gene expression in the adipose tissue of postmenopausal women .
METHODS	This double-blind , randomized , placebo-controlled crossover intervention consisted of 2 substudies , one with a low-genistein ( LG ) supplement ( 56 % daidzein + daidzin , 16 % genistein + genistin , and 28 % glycitein + glycitin ) and the other with a high-genistein ( HG ) supplement ( 49 % daidzein + daidzin , 41 % genistein + genistin , and 10 % glycitein + glycitin ) .
METHODS	Both supplements provided 100 mg isoflavones/d ( aglycone equivalents ) .
METHODS	After the 8-wk isoflavone and placebo period , whole-genome arrays were performed in subcutaneous adipose tissue of postmenopausal women ( n = 26 after LG , n = 31 after HG ) .
METHODS	Participants were randomized by equol-producing phenotype , and data analysis was performed per substudy for equol producers and nonproducers separately .
RESULTS	Gene set enrichment analysis showed downregulation of expression of energy metabolism-related genes after LG supplementation ( n = 24 ) in both equol-producing phenotypes and oppositely regulated expression for equol producers ( down ) and nonproducers ( up ) after HG supplementation ( n = 31 ) .
RESULTS	Expression of inflammation-related genes was upregulated in equol producers but downregulated in nonproducers , independent of supplement type .
RESULTS	Only 4.4-7 .0 % of the genes with significantly changed expression were estrogen responsive .
RESULTS	Body weight , adipocyte size , and plasma lipid profile were not affected by isoflavone supplementation .
CONCLUSIONS	Effects of isoflavones on adipose tissue gene expression were influenced by supplement composition and equol-producing phenotype , whereas estrogen-responsive effects were lacking .
CONCLUSIONS	LG isoflavone supplementation resulted in a caloric restriction-like gene expression profile for both producer phenotypes and pointed toward a potential beneficial effect , whereas both supplements induced anti-inflammatory gene expression in equol producers .
CONCLUSIONS	The study was registered at clinicaltrials.gov as NCT01556737 .

###25907999
OBJECTIVE	To confirm the non-inferiority of the IOP-lowering effect of the 0.0015 % Tafluprost ophthalmic solution to the 0.005 % Latanoprost ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.Safety was also compared between two groups .
METHODS	This study was conducted from August 2008 to December 2009 , at five clinical trial sites in China .
METHODS	Patients of this study population was diagnosed with primary open-angle glaucoma or ocular hypertension in both eyes.Subjects were randomized into 0.0015 % Tafluprost group or 0.005 % Latanoprost group.Intraocular pressure ( IOP ) measurement by Goldmann applanation tonometer , slit-lamp microscopy , Gonioscopy , Fundascopy , Visual acuity test , Perimetry , Blood pressure and pulse rate , Subjective symptoms were compered between two groups at Week 0 , Week 2 and Week 4 .
METHODS	For main effectiveness evaluation index adopt the bad effect evaluation , safety evaluation index by Fisher 's exact test probability method .
RESULTS	The 246 subjects/246 eyes were randomized ( Tafluprost group :122 subjects/122 eyes , Latanoprost group :124 subjects / 124 eyes ) .
RESULTS	Change in the IOP at 17:00 of Week 2 is ( 8.8 3.8 ) mmHg and ( 8.9 4.4 ) mmHg ( 1 mmHg = 0.133 kPa ) in Tafluprost group and Latanoprost group .
RESULTS	Percent change in the IOP at 17:00 of Week 2 is ( 33.2 12.8 ) % and ( 34.4 14.1 ) % in Tafluprost group and Latanoprost group .
RESULTS	Change in the IOP at 17:00 at the end of treatment is ( 9.8 4.0 ) mmHg and ( 9.2 4.1 ) mmHg in Tafluprost group and Latanoprost group .
RESULTS	Percent change in the IOP at 17:00 at the end of treatment is 37.2 % 13.4 % group and 35.7 % 13.0 % in Tafluprost and Latanoprost group.In addition , distribution of subjects with percentage decrease of IOP > 30 % was 72.5 % in Tafluprost group higher than 63.8 % in Latanoprost group .
RESULTS	The major adverse reactions were conjunctival hyperemia , eye irritation , eye pain and foreign body sensation .
RESULTS	The incidence of adverse reactions is 31.7 % in Tafluprost group and 20.8 % in Latanoprost group .
RESULTS	The inter-group difference had no statistical significance .
CONCLUSIONS	Efficacy and safety of Tafluprost ophthalmic solution are no less than Latanoprost ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension .

###25308290
BACKGROUND	Disease-modifying biological agents and other drug regimens have substantially improved control of disease activity and joint damage in people with rheumatoid arthritis of the hand .
BACKGROUND	However , commensurate changes in function and quality of life are not always noted .
BACKGROUND	Tailored hand exercises might provide additional improvements , but evidence is lacking .
BACKGROUND	We estimated the effectiveness and cost-effectiveness of tailored hand exercises in addition to usual care during 12 months .
METHODS	In this pragmatic , multicentre , parallel-group trial , at 17 National Health Service sites across the UK we randomly assigned 490 adults with rheumatoid arthritis who had pain and dysfunction of the hands and had been on a stable drug regimen for at least 3 months , to either usual care or usual care plus a tailored strengthening and stretching hand exercise programme .
METHODS	Participants were randomly assigned with stratification by centre .
METHODS	Allocation was computer generated and unmasked to participants and therapists delivering treatment after randomisation .
METHODS	Outcome assessors and all investigators were masked to allocation .
METHODS	Physiotherapists or occupational therapists gave the treatments .
METHODS	The primary outcome was the Michigan Hand Outcomes Questionnaire overall hand function score at 12 months .
METHODS	The analysis was by intention to treat .
METHODS	We calculated cost per quality-adjusted life-year .
METHODS	This trial is registered as ISRCTN 89936343 .
RESULTS	Between Oct 5 , 2009 , and May 10 , 2011 , we screened 1606 people , of whom 490 were randomly assigned to usual care ( n = 244 ) or tailored exercises ( n = 246 ) .
RESULTS	438 of 490 participants ( 89 % ) provided 12 month follow-up data .
RESULTS	Improvements in overall hand function were 36 points ( 95 % CI 15-57 ) in the usual care group and 79 points ( 60-99 ) in the exercise group ( mean difference between groups 43 , 95 % CI 15-71 ; p = 00028 ) .
RESULTS	Pain , drug regimens , and health-care resource use were stable for 12 months , with no difference between the groups .
RESULTS	No serious adverse events associated with the treatment were recorded .
RESULTS	The cost of tailored hand exercise was 156 per person ; cost per quality-adjusted life-year was 9549 with the EQ-5D ( 17,941 with imputation for missing data ) .
CONCLUSIONS	We have shown that a tailored hand exercise programme is a worthwhile , low-cost intervention to provide as an adjunct to various drug regimens .
CONCLUSIONS	Maximisation of the benefits of biological and DMARD regimens in terms of function , disability , and health-related quality of life should be an important treatment aim .
BACKGROUND	UK National Institute of Health Research Health Technology Assessment Programme ( NIHR HTA ) , project number 07/32/05 .

###24468886
BACKGROUND	A pegylated recombinant human granulocyte colony-stimulating factor ( G-CSF ) is effective in reducing the severity and duration of neutropenia .
BACKGROUND	This study was performed to investigate the pharmacokinetics ( PK ) , pharmacodynamics ( PD ) , and tolerability of GCPGC , a new formulation of pegylated G-CSF , in healthy volunteers and to compare them with those of pegfilgrastim ( Neulasta ) .
METHODS	Twenty-five healthy Korean male volunteers randomly received a single subcutaneous ( SC ) GCPGC injection at a dose of 30 ( n = 10 ) , 100 ( n = 10 ) , or 300 ( n = 5 ) g/kg or placebo in a 4:1 ratio in a double-blind manner .
METHODS	Additionally , 8 subjects received a SC dose of pegfilgrastim at 100 g/kg .
METHODS	Blood samples were collected up to 14 days after both therapies .
METHODS	The absolute neutrophil count ( ANC ) and CD34 ( + ) cell counts were the PD markers .
RESULTS	After GCPGC administration , 4 different pharmacokinetic phases were identified , indicating target-mediated drug disposition ( TMDD ) for the elimination of GCPGC , which was slowed down as the dose was increased , resulting in a higher than proportional dose-normalized exposure to GCPGC .
RESULTS	Although GCPGC was cleared faster than pegfilgrastim , leading to a 19 % lower systemic exposure to pegylated G-CSF , the increase in ANC and CD34 ( + ) were ~ 20 % greater by GCPGC at 100 g/kg than pegfilgrastim .
RESULTS	Thrombocytopenia , splenomegaly , and hemoperitoneum occurred in one subject in the 300 g/kg GCPGC group , which resolved completely with appropriate care .
CONCLUSIONS	GCPGC showed a non-linear TMDD .
CONCLUSIONS	The PK-PD characteristics of GCPGC at 30-100 g/kg were comparable to those of pegfilgrastim at 100 g/kg .
CONCLUSIONS	GCPGC at 30-100 g/kg was well tolerated in healthy Korean males .

###25649881
CONCLUSIONS	Additional treatment with clarithromycin ( CAM ) reduced persistent middle ear inflammation after acute otitis media ( AOM ) caused by Haemophilus influenzae in children .
CONCLUSIONS	CAM is a treatment option for persistent inflammation following AOM and to prevent continuing otitis media with effusion .
OBJECTIVE	We conducted a clinical study to evaluate a new method of treatment for persistent inflammation after AOM in children .
METHODS	H. influenzae-infected children with AOM were treated acutely with antimicrobial agents , after which those still demonstrating effusion of the middle ear cavity received additional treatment with carbocysteine ( S-CMC ) alone or S-CMC combined with clarithromycin ( CAM ) for 1 week .
METHODS	The two regimens were compared in terms of clinical effects .
RESULTS	After the initial acute treatment , many patients still showed abnormal otoscopic findings .
RESULTS	At the completion of additional treatment , there were no significant differences between the two treatment groups .
RESULTS	However , 1 week after completion of additional treatment , the prevalence of a diminished light reflex was significantly lower in the CAM + S-CMC group than in the S-CMC group ( p = 0.017 ) .
RESULTS	The prevalence of redness of the tympanic membrane also tended to be lower in the combined treatment group than in those receiving a single drug ( p = 0.097 ) .

###25981871
BACKGROUND	A number of people are reporting an environmental sensitivity to sub-audible windfarm sound ( infrasound ) , characterised by the experience of recurrent non-specific symptoms .
BACKGROUND	A causal link between exposure and symptoms is not indicated by empirical evidence .
BACKGROUND	Research indicates symptoms may be explained by the nocebo response , whereby health concerns and negative expectations , created from social discourse and media reports , trigger symptom reporting .
OBJECTIVE	The experimental aim was to test whether providing a nocebo explanation for symptoms , to individuals reporting symptomatic experiences during infrasound exposure , would ameliorate symptoms during further exposure .
METHODS	Sixty-six volunteers were randomly assigned to nocebo explanation or biological explanation groups .
METHODS	Participants were concurrently exposed to infrasound and audible windfarm sound , while reporting on current symptoms and mood , during two exposure sessions .
METHODS	Preceding session one , participants watched a presentation integrating media warnings about purported health risks posed by windfarm infrasound .
METHODS	Before session two , nocebo explanation participants viewed material outlining how nocebo responding could explain symptom reporting .
METHODS	Instead biological explanation participants watched material presenting pathophysiological theories for symptoms .
RESULTS	During session one , participants reported increased symptoms and mood deterioration from baseline assessment .
RESULTS	During session two symptom reporting and mood deterioration was maintained by biological explanation participants , while mood and symptoms reported by nocebo explanation participants returned to baseline levels .
CONCLUSIONS	Results indicate that providing an explanation of the nocebo response , followed by exposure to infrasound , has the potential to operate as an intervention to reduce symptomatic experiences in people reporting symptoms attributed to windfarm generated infrasound .

###25034547
OBJECTIVE	The aim of the study was to examine the effect of a very short-term training program on the immediate and late changes in the fitness level of young soccer players during the pre-season period .
METHODS	Twenty-four young ( 17-18 years ) soccer players were randomly assigned to either an interval ( 9 to 5 X 1000 m ) or continuous ( 9000 to 5000 m ) training group , matched for total running distance .
METHODS	While the number of intervals or total distance was reduced every day , speed was increased in each session throughout the five days of both training programs .
METHODS	Each group performed 20 m shuttle run , 10 m sprint , 5 X 10 m run , 250 m run and vertical jump test , before ( pre ) , immediately after ( post ) and 10 days after ( late ) completion of five successive training days during the preseason period for the upcoming soccer season .
RESULTS	There was a significant increase in aerobic capacity both immediately post-training and in the late test , in both training groups .
RESULTS	We found a significantly greater reduced performance in the 250 m run immediately following training in the interval compared to the continuous training group .
RESULTS	In addition , there was a decrease in vertical jump that was significantly greater in the interval compared to the continuous training group , both immediately post-training and in the late test .
CONCLUSIONS	Very short interval or continuous preseason training programs induce significant improvement in aerobic fitness but lead to stagnation or deterioration in anaerobic performance .
CONCLUSIONS	Considering the opposing effects of both training modes ( positive on the aerobic power but negative on the anaerobic performance ) , coaches should make their choices based on the relevant conditions at hand .

###25605582
BACKGROUND	Accelerated partial breast irradiation ( APBI ) has been introduced as an alternative treatment method for selected patients with early stage breast cancer ( BC ) .
BACKGROUND	Intensity-modulated radiotherapy ( IMRT ) has the theoretical advantage of a further increase in dose conformity compared with three-dimensional techniques , with more normal tissue sparing .
BACKGROUND	The aim of this randomised trial is to compare the local recurrence and survival of APBI using the IMRT technique after breast-conserving surgery to conventional whole-breast irradiation ( WBI ) in early stage BC .
METHODS	This study was performed at the University of Florence ( Florence , Italy ) .
METHODS	Women aged more than 40years affected by early BC , with a maximum pathological tumour size of 25mm , were randomly assigned in a 1:1 ratio to receive either WBI or APBI using IMRT .
METHODS	Patients in the APBI arm received a total dose of 30 Gy to the tumour bed in five daily fractions .
METHODS	The WBI arm received 50Gy in 25 fractions , followed by a boost on the tumour bed of 10Gy in five fractions .
METHODS	The primary end-point was occurrence of ipsilateral breast tumour recurrences ( IBTRs ) ; the main analysis was by intention-to-treat .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT02104895 .
RESULTS	A total of 520 patients were randomised ( 260 to external WBI and 260 to APBI with IMRT ) between March 2005 and June 2013 .
RESULTS	At a median follow-up of 5.0 years ( Interquartile Range ( IQR ) 3.4-7 .0 ) , the IBTR rate was 1.5 % ( three cases ) in the APBI group ( 95 % confidence interval ( CI ) 0.1-3 .0 ) and in the WBI group ( three cases ; 95 % CI 0.0-2 .8 ) .
RESULTS	No significant difference emerged between the two groups ( log rank test p = 0.86 ) .
RESULTS	We identified seven deaths in the WBI group and only one in the APBI group ( p = 0.057 ) .
RESULTS	The 5-year overall survival was 96.6 % for the WBI group and 99.4 % for the APBI group .
RESULTS	The APBI group presented significantly better results considering acute ( p = 0.0001 ) , late ( p = 0.004 ) , and cosmetic outcome ( p = 0.045 ) .
CONCLUSIONS	To our knowledge , this is the first randomised study using the IMRT technique for APBI delivery .
CONCLUSIONS	No significant difference in terms of IBTR and overall survival was observed between the two arms .
CONCLUSIONS	APBI displayed a significantly better toxicity profile .

###25060803
BACKGROUND	Photodynamic therapy ( PDT ) is an effective and established treatment for actinic keratoses ( AK ) and nonmelanoma skin cancer .
BACKGROUND	The main side-effects of PDT are post-treatment erythema and oedema , and pain during illumination .
BACKGROUND	Severe erythema after PDT enhances the down time associated with the treatment .
OBJECTIVE	To evaluate in a randomized intraindividual study whether use of a topical corticosteroid just before and just after PDT would reduce treatment-induced erythema compared with conventional PDT .
METHODS	Twenty-two patients with multiple AKs in the face and scalp were treated with methyl aminolaevulinate PDT in two symmetrical areas .
METHODS	One area was randomized to superpotent corticosteroid ( clobetasol propionate ) before and just after PDT .
METHODS	Objective and visual erythema , protoporphyrin IX ( PpIX ) fluorescence and pain were evaluated .
RESULTS	Topical corticosteroid significantly reduced PDT-induced erythema ( P = 0012 ) .
RESULTS	The complete lesion response rate 3 months after PDT , and PpIX fluorescence prior to illumination did not differ significantly between the two treated areas .
CONCLUSIONS	Superpotent corticosteroid before and just after PDT reduced the erythema 24 h after treatment of multiple AKs on the face and scalp .
CONCLUSIONS	The use of topical corticosteroid did not affect the efficacy of PDT and may be an easy way to make PDT treatment of large visible areas more acceptable .

###25364070
OBJECTIVE	Determine the effects of high versus moderate workload on sleep physiology and neurobehavioral measures , during sleep restriction ( SR ) and no sleep restriction ( NSR ) conditions .
METHODS	Ten-night experiment involving cognitive workload and SR manipulations .
METHODS	Controlled laboratory environment .
METHODS	Sixty-three healthy adults ( mean standard deviation : 33.2 8.7 y ; 29 females ) , age 22-50 y.
METHODS	Following three baseline 8 h time in bed ( TIB ) nights , subjects were randomized to one of four conditions : high cognitive workload ( HW ) + SR ; moderate cognitive workload ( MW ) + SR ; HW + NSR ; or MW + NSR .
METHODS	SR entailed 5 consecutive nights at 4 h TIB ; NSR entailed 5 consecutive nights at 8 h TIB .
METHODS	Subjects received three workload test sessions/day consisting of 15-min preworkload assessments , followed by a 60-min ( MW ) or 120-min ( HW ) workload manipulation comprised of visually based cognitive tasks , and concluding with 15-min of postworkload assessments .
METHODS	Experimental nights were followed by two 8-h TIB recovery sleep nights .
METHODS	Polysomnography was collected on baseline night 3 , experimental nights 1 , 4 , and 5 , and recovery night 1 using three channels ( central , frontal , occipital [ C3 , Fz , O2 ] ) .
RESULTS	High workload , regardless of sleep duration , increased subjective fatigue and sleepiness ( all P < 0.05 ) .
RESULTS	In contrast , sleep restriction produced cumulative increases in Psychomotor Vigilance Test ( PVT ) lapses , fatigue , and sleepiness and decreases in PVT response speed and Maintenance of Wakefulness Test ( MWT ) sleep onset latencies ( all P < 0.05 ) .
RESULTS	High workload produced longer sleep onset latencies ( P < 0.05 , d = 0.63 ) and less wake after sleep onset ( P < 0.05 , d = 0.64 ) than moderate workload .
RESULTS	Slow-wave energy-the putative marker of sleep homeostasis-was higher at O2 than C3 only in the HW + SR condition ( P < 0.05 ) .
CONCLUSIONS	High cognitive workload delayed sleep onset , but it also promoted sleep homeostatic responses by increasing subjective fatigue and sleepiness , and producing a global sleep homeostatic response by reducing wake after sleep onset .
CONCLUSIONS	When combined with sleep restriction , high workload increased local ( occipital ) sleep homeostasis , suggesting a use-dependent sleep response to visual work .
CONCLUSIONS	We conclude that sleep restriction and cognitive workload interact to influence sleep homeostasis .

###25251043
OBJECTIVE	In patients with cirrhosis and small hepatocellular carcinoma ( HCC ) , thermal ablation is currently recognized as an effective local treatment .
OBJECTIVE	Among thermal procedures , radiofrequency ablation ( RFA ) is the most diffusely used and is the standard against which any new treatment should be compared .
OBJECTIVE	In retrospective studies , laser ablation ( LA ) resulted as safe and effective as RFA .
OBJECTIVE	Therefore , we performed a non-inferiority randomized trial comparing RFA with LA in patients with cirrhosis and HCC within Milan criteria .
METHODS	Overall , 140 patients with 157 HCC nodules were randomly assigned to receive RFA or LA. .
METHODS	The primary end-point was the proportion of complete tumor ablation ( CTA ) .
METHODS	Secondary end-points were time to local progression ( TTLP ) and overall survival ( OS ) .
RESULTS	Per patient CTA rates after RFA and LA were 97.4 % ( 95 % CI , 91.0-99 .3 ) and 95.7 % ( 88.1-98 .5 ) , respectively ( difference = 1.4 % , 95 % CI from -6.0 % to +9.0 % ) .
RESULTS	Per nodule CTA rates for RFA and LA were 97.4 % ( 91.0-99 .3 ) and 96.3 % ( 89.6-98 .7 ) , respectively ( difference = 1.1 % , from -5.7 % to +8.1 % ) .
RESULTS	The mean TTLP was comparable between RFA group ( 42.0 months ; 95 % CI , 36.83-47 .3 ) and LA group ( 46.7 months ; 95 % CI , 41.5-51 .9 ) ( P = .591 ) .
RESULTS	The mean OS was 42 months in both groups and survival probability at 1 and 3 years was 94 % and 89 % in RFA group , and 94 % and 80 % in LA group .
CONCLUSIONS	LA resulted not inferior to RFA in inducing the CTA of HCC nodules and therefore it should be considered as an evaluable alternative for thermal ablation of small HCC in cirrhotic patients .

###25231095
BACKGROUND	Refractory angina constitutes a clinical problem .
OBJECTIVE	The aim of this study was to assess the safety and the feasibility of transendocardial injection of CD133 ( + ) cells to foster angiogenesis in patients with refractory angina .
RESULTS	In this randomized , double-blinded , multicenter controlled trial , eligible patients were treated with granulocyte colony-stimulating factor , underwent an apheresis and electromechanical mapping , and were randomized to receive treatment with CD133 ( + ) cells or no treatment .
RESULTS	The primary end point was the safety of transendocardial injection of CD133 ( + ) cells , as measured by the occurrence of major adverse cardiac and cerebrovascular event at 6 months .
RESULTS	Secondary end points analyzed the efficacy .
RESULTS	Twenty-eight patients were included ( n = 19 treatment ; n = 9 control ) .
RESULTS	At 6 months , 1 patient in each group had ventricular fibrillation and 1 patient in each group died .
RESULTS	One patient ( treatment group ) had a cardiac tamponade during mapping .
RESULTS	There were no significant differences between groups with respect to efficacy parameters ; however , the comparison within groups showed a significant improvement in the number of angina episodes per month ( median absolute difference , -8.5 [ 95 % confidence interval , -15.0 to -4.0 ] ) and in angina functional class in the treatment arm but not in the control group .
RESULTS	At 6 months , only 1 simple-photon emission computed tomography ( SPECT ) parameter : summed score improved significantly in the treatment group at rest and at stress ( median absolute difference , -1.0 [ 95 % confidence interval , -1.9 to -0.1 ] ) but not in the control arm .
CONCLUSIONS	Our findings support feasibility and safety of transendocardial injection of CD133 ( + ) cells in patients with refractory angina .
CONCLUSIONS	The promising clinical results and favorable data observed in SPECT summed score may set up the basis to test the efficacy of cell therapy in a larger randomized trial .

###24557659
OBJECTIVE	The goal of our study was to determine if lymph node activity could be visualized using a hybrid single-photon emission computed tomography/computed tomography ( SPECT/CT ) scanner with two commonly used colloidal lymphatic radiotracers -- 99mTc-antimony sulfide colloid ( ASC ) and 99mTc-filtered sulfur colloid ( FSC ) in the setting of low-stage non-small cell lung cancer ( NSCLC ) .
METHODS	Patients undergoing CT-guided percutaneous lung biopsies for clinically suspected early-stage lung cancer were randomized to peri-lesional injection of 37 MBq ( 0.5 mL ) of either ASC or FSC .
METHODS	SPECT/CT of the thorax was performed at either 1 , 2 , or 3 h post-injection .
METHODS	The images were reviewed to determine if lymph node activity separate from the injection site could be identified .
RESULTS	24 patients were included .
RESULTS	Lymph node activity was identified in 50 % of patients .
RESULTS	A total of 15 lymph nodes with activity were visualized including 5 ipsilateral hilar , 6 ipsilateral mediastinal , and 4 distant locations .
RESULTS	No contralateral mediastinal or hilar activity was visualized .
RESULTS	There was a tendency to improved visualization with ASC and the longer 3 h wait time .
RESULTS	Most patients also demonstrated significant pleural , tracheobronchial , and/or systemic activity .
CONCLUSIONS	SPECT/CT imaging can demonstrate lymph node activity separate from the injection site in at least some low-stage NSCLC patients with a perilesional injection of 99mTc nanocolloid tracers .
CONCLUSIONS	Further investigation into the role of pre-operative lymphoscintigraphy with SPECT/CT in patients with lung cancer is warranted .

###24796041
OBJECTIVE	To explore the comprehensive program of integrated Chinese and western medicine in the treatment of cognitive impairment in earthquake brain injury .
METHODS	The multi-central randomized controlled trial was adopted .
METHODS	The qualified subjects were randomized into an acupuncture + rehabilitation group ( 38 cases ) and a rehabilitation group ( 35 cases ) .
METHODS	In the acupuncture + rehabilitation group , acupuncture , hyperbaric oxygen ( HBO ) and cognitive rehabilitation training were combined as the comprehensive program of integrated Chinese and western medicine in the treatment .
METHODS	In the rehabilitation group , HBO and cognitive rehabilitation training were adopted .
METHODS	The efficacy and safety were assessed .
RESULTS	( 1 ) After treatment of 2 months , the intelligent state , cognitive function and activity of daily life of patients were improved in the both groups ( all P < 0.01 ) .
RESULTS	( 2 ) After treatment of 2 months , the score of MMSE and the score of activity of daily life were ( 24.11 + / - 4.08 ) and ( 75.45 + / - 13.95 ) in the acupuncture + rehabilitation group , which were more significant as compared with ( 17.05 + / - 43.84 ) , ( 66.06 + / - 12.75 ) in the rehabilitation group , respectively ( both P < 0.01 ) .
RESULTS	In 6-month follow-up visit after treatment , the cognitive function and activity of daily life were improved continuously in the acupuncture + rehabilitation group , which was more significant as compared with the rehabilitation group ( P < 0.01 , P < 0.05 ) .
CONCLUSIONS	The integrated Chinese and western medicine of acupuncture , HBO and cognitive rehabilitation training is safe and effective in the treatment of cognitive impairment in earthquake brain injury .
CONCLUSIONS	The therapeutic effect is more advantageous as compared with the simple rehabilitation program of western medicine .

###25172115
OBJECTIVE	Urology clinical trials assessing bladder function have relied on the self-reported duration of the first uninterrupted sleep period ( FUSP ) as a proxy outcome for sleep , but the relationship between this measure and more conventional self-reported measures of sleep is unknown .
OBJECTIVE	In this study , we examined the association between changes in FUSP and a widely used self-reported measure of sleep , the Pittsburgh Sleep Quality Index ( PSQI ) .
METHODS	We conducted post hoc ( secondary ) analyses of unpublished data from a previously published randomized clinical trial ( NCT00477490 ) of desmopressin ( a medication used to treat nocturia ) and examined relationships between baseline and 4-week change in FUSP and PSQI global and subscale scores for participants ( N = 580 to N = 606 ) having complete data .
RESULTS	Data indicated strong associations between change in PSQI global score and FUSP change in six of seven subscale scores .
RESULTS	A reduction of 1.8 points in the PSQI global score was associated with a 72-min lengthening of FUSP .
CONCLUSIONS	Results suggest that FUSP is a potentially valuable metric that correlates with changes in perceived sleep duration , depth , quality for the entire night , efficiency , latency , and daytime function .
CONCLUSIONS	An increase in FUSP was related to improvement in nearly all PSQI subscales .
CONCLUSIONS	The validity of this measure in the general population remains to be determined .

###24609919
OBJECTIVE	To evaluate the impact of a diet and physical activity intervention ( BeWEL ) on weight change in people with a body mass index > 25 weight ( kg ) / height ( m ) ( 2 ) at increased risk of colorectal cancer and other obesity related comorbidities .
METHODS	Multicentre , parallel group , randomised controlled trial .
METHODS	Four Scottish National Health Service health boards .
METHODS	329 overweight or obese adults ( aged 50 to 74 years ) who had undergone colonoscopy after a positive faecal occult blood test result , as part of the national bowel screening programme , and had a diagnosis of adenoma confirmed by histopathology .
METHODS	163 were randomised to intervention and 166 to control .
METHODS	Participants were randomised to a control group ( weight loss booklet only ) or 12 month intervention group ( three face to face visits with a lifestyle counsellor plus monthly 15 minute telephone calls ) .
METHODS	A goal of 7 % reduction in body weight was set and participants received a personalised energy prescription ( 2508 kJ ( 600 kcal ) below that required for weight maintenance ) and bodyweight scales .
METHODS	Motivational interviewing techniques explored self assessed confidence , ambivalence , and personal values concerning weight .
METHODS	Behavioural strategies included goal setting , identifying intentions of implementation , self monitoring of body weight , and counsellor feedback about reported diet , physical activity , and weight change .
METHODS	The primary outcome was weight change over 12 months .
METHODS	Secondary outcomes included changes in waist circumference , blood pressure , fasting cardiovascular biomarkers , and glucose metabolism variables , physical activity , diet , and alcohol consumption .
RESULTS	At 12 months , data on the primary outcome were available for 148 ( 91 % ) participants in the intervention group and 157 ( 95 % ) in the control group .
RESULTS	Mean weight loss was 3.50 kg ( SD 4.91 ) ( 95 % confidence interval 2.70 to 4.30 ) in the intervention group compared with 0.78 kg ( SD 3.77 ) ( 0.19 to 1.38 ) in the control group .
RESULTS	The group difference was 2.69 kg ( 95 % confidence interval 1.70 to 3.67 ) .
RESULTS	Differences between groups were significant for waist circumference , body mass index , blood pressure , blood glucose level , diet , and physical activity .
RESULTS	No reported adverse events were considered to be related to trial participation .
CONCLUSIONS	Significant weight loss can be achieved by a diet and physical activity intervention initiated within a national colorectal cancer screening programme , offering considerable potential for risk reduction of disease in older adults .
BACKGROUND	Current Controlled Trials ISRCTN53033856 .

###25722977
BACKGROUND	We tested the hypothesis that warm-humidified carbon dioxide ( CO2 ) insufflation would reduce postoperative pain and morphine requirement compared to cold-dry CO2 insufflation .
METHODS	A double-blinded , randomized , controlled trial was conducted to compare warm , humidified CO2 and cold-dry CO2 .
METHODS	Patients with benign uterine diseases were randomized to either treatment ( n = 48 ) or control ( n = 49 ) group during laparoscopically assisted vaginal hysterectomy .
METHODS	Primary endpoints of the study were rest pain , movement pain , shoulder-tip pain , and cough pain at 2 , 4 , 6 , 24 , and 48 hours postoperatively , measured by visual analogue scale .
METHODS	Secondary outcomes were morphine consumption , rejected boli , temperature change , recovery room stay , and length of hospital stay .
RESULTS	There were no significant differences in all baseline characteristics .
RESULTS	Shoulder-tip pain at 6 h postoperatively was significantly reduced in the intervention group .
RESULTS	Pain at rest , movement pain , and cough pain did not differ .
RESULTS	Total morphine consumption and rejected boli at 24 h postoperatively were significantly higher in the control group .
RESULTS	Temperature change , recovery room stay , and length of hospital were similar .
CONCLUSIONS	Warm , humidified insufflation gas significantly reduces postoperative shoulder-tip pain as well as morphine demand .
CONCLUSIONS	This trial is registered with Clinical Trial Registration Number DRKS00003853 ( German Clinical Trials Register ( DRKS ) ) .

###25733635
BACKGROUND	Research indicates that the chronic consumption of flavonoids is associated with cognitive benefits in adults with mild cognitive impairment and neurodegenerative disease , although to our knowledge , there have been no such studies in healthy older adults .
BACKGROUND	Furthermore , the effects of commonly consumed orange juice flavanones on cognitive function remain unexplored .
OBJECTIVE	We investigated whether 8 wk of daily flavanone-rich orange juice consumption was beneficial for cognitive function in healthy older adults .
METHODS	High-flavanone ( 305 mg ) 100 % orange juice and an equicaloric low-flavanone ( 37 mg ) orange-flavored cordial ( 500 mL ) were consumed daily for 8 wk by 37 healthy older adults ( mean age : 67 y ) according to a crossover , double-blind , randomized design separated by a 4-wk washout .
METHODS	Cognitive function , mood , and blood pressure were assessed at baseline and follow-up by using standardized validated tests .
RESULTS	Global cognitive function was significantly better after 8-wk consumption of flavanone-rich juice than after 8-wk consumption of the low-flavanone control .
RESULTS	No significant effects on mood or blood pressure were observed .
CONCLUSIONS	Chronic daily consumption of flavanone-rich 100 % orange juice over 8 wk is beneficial for cognitive function in healthy older adults .
CONCLUSIONS	The potential for flavanone-rich foods and drinks to attenuate cognitive decline in aging and the mechanisms that underlie these effects should be investigated .

###24700332
OBJECTIVE	Computer-delivered interventions have the potential to improve access to quality addiction treatment care .
OBJECTIVE	The objective of this study was to evaluate the effectiveness of the Therapeutic Education System ( TES ) , an Internet-delivered behavioral intervention that includes motivational incentives , as a clinician-extender in the treatment of substance use disorders .
METHODS	Adult men and women ( N = 507 ) entering 10 outpatient addiction treatment programs were randomly assigned to receive 12 weeks of either treatment as usual ( N = 252 ) or treatment as usual plus TES , with the intervention substituting for about 2 hours of standard care per week ( N = 255 ) .
METHODS	TES consists of 62 computerized interactive modules covering skills for achieving and maintaining abstinence , plus prize-based motivational incentives contingent on abstinence and treatment adherence .
METHODS	Treatment as usual consisted of individual and group counseling at the participating programs .
METHODS	The primary outcome measures were abstinence from drugs and heavy drinking ( measured by twice-weekly urine drug screens and self-report ) and time to dropout from treatment .
RESULTS	Compared with patients in the treatment-as-usual group , those in the TES group had a lower dropout rate ( hazard ratio = 0.72 , 95 % CI = 0.57 , 0.92 ) and a greater abstinence rate ( odds ratio = 1.62 , 95 % CI = 1.12 , 2.35 ) .
RESULTS	This effect was more pronounced among patients who had a positive urine drug or breath alcohol screen at study entry ( N = 228 ) ( odds ratio = 2.18 , 95 % CI = 1.30 , 3.68 ) .
CONCLUSIONS	Internet-delivered interventions such as TES have the potential to expand access and improve addiction treatment outcomes .
CONCLUSIONS	Additional research is needed to assess effectiveness in non-specialty clinical settings and to differentiate the effects of the community reinforcement approach and contingency management components of TES .

###25623903
OBJECTIVE	Statins improve overall outcomes after noncardiac surgery .
OBJECTIVE	The primary aim of the study was to determine whether use of perioperative atorvastatin reduced the rate of postoperative complications in patients undergoing pulmonary resection .
METHODS	This was a prospective , randomized , placebo-controlled , double-blind trial of patients undergoing elective pulmonary resection who received atorvastatin ( 40 mg daily ) or placebo beginning 1 week before surgery and continued for 1 week postoperatively .
METHODS	Patient characteristics and postoperative complications were recorded .
METHODS	Plasma inflammatory markers were sampled at baseline , in the post-anesthesia care unit , and on postoperative day 3 .
METHODS	Because of difficulty enrolling statin-naive patients , the study was stopped at the interim analysis .
RESULTS	Postoperative complications occurred in 16 of 72 patients ( 22 % ) receiving placebo and in 8 of 65 patients ( 12 % ) receiving atorvastatin ( P = .13 ) .
RESULTS	For patients undergoing major anatomic resection , there were 24 complications in 15 of 45 placebo-treated patients and 8 complications in 7 of 43 atorvastatin-treated patients ( P = .04 ) .
RESULTS	Plasma levels of C-reactive protein , tumor necrosis factor - , and myeloperoxidase did not differ between the 2 treatment arms during the study .
CONCLUSIONS	After a 2-week perioperative course of atorvastatin ( 40 mg ) in statin-nave patients undergoing major pulmonary resection , we found evidence of a reduction in the number of clinically important cardiovascular and pulmonary complications compared with placebo .
CONCLUSIONS	These promising results merit evaluation in a larger , perhaps multicenter study .

###25868409
BACKGROUND	Skin graft donor sites are notoriously painful , with potential complications of fluid loss , delayed healing , infection , and hypertrophic scarring , particularly in patients with burns or traumatic injury .
BACKGROUND	In this population , rapid epithelialization is critical to reducing morbidity and cost .
METHODS	This prospective , randomized controlled trial compared the effects of 40-kHz noncontact low-frequency ultrasound ( NLFU ) in addition to standard care ( SC ) with SC alone in subjects with split-thickness donor sites of 20 to 200 cm ( 2 ) .
METHODS	Standard care consisted of cleansing and moist wound dressings .
METHODS	Outcomes measured were time to healing , defined as absence of drainage and full epithelialization ; pain and itching scores ; and recidivism rates .
RESULTS	Of 33 patients enrolled ; 27 were randomized and received a minimum of 4 study treatments .
RESULTS	Median age was 49 years , 69 % were male , and 84 % were burn patients .
RESULTS	Comorbidities included hypertension ( 31 % ) , coronary artery disease ( 22 % ) , pulmonary disease ( 38 % ) , anemia ( 31 % ) , and diabetes ( 16 % ) .
RESULTS	Median donor site area was 136.0 cm ( 2 ) .
RESULTS	Noncontact low-frequency ultrasound and SC compared with SC demonstrated a mean time to heal of 12.1 days vs 21.3 days ( p = 0.04 ) .
RESULTS	All NLFU+SC subjects had epithelialized by 4 weeks compared with only 71 % in SC .
RESULTS	Recidivism rates were 8 % for NLFU+SC compared with 45 % for SC .
RESULTS	Pain scores were reduced and significant differences in itching were observed .
CONCLUSIONS	Noncontact low-frequency ultrasound and SC compared with SC alone in the treatment of split-thickness donor sites demonstrated significant accelerated healing and reduced pain and itching .
CONCLUSIONS	Noncontact low-frequency ultrasound subjects experienced a better quality of healing with less incidence of infection and recidivism .

###24330860
OBJECTIVE	The aim of this analysis was to compare the effects of 2 atypical antipsychotic agents , lurasidone ( 80 mg/d or 160 mg/d ) and quetiapine XR ( 600 mg/d ) , on daytime alertness , and to evaluate the effects of daytime sleepiness on treatment outcomes in patients with an acute exacerbation of schizophrenia .
METHODS	Patients who met Diagnostic and Statistical Manual of Mental Disorders , 4th edition , text revision ( DSM-IV-TR ) criteria for schizophrenia were randomized to 6 weeks of double-blind treatment with fixed doses of lurasidone 80 mg/d ( n = 125 ) , lurasidone 160 mg/d ( n = 121 ) , quetiapine XR 600 mg/d ( n = 119 ) , or placebo ( n = 121 ) , all dosed once daily in the evening , with food .
METHODS	Daytime sleepiness was assessed using the Epworth Sleepiness Scale ( ESS ) .
RESULTS	Daytime sleepiness improved in the lurasidone and placebo-treated groups but worsened in the quetiapine XR treatment group when compared to placebo ( p = 0.001 ) and to either dose of lurasidone ( both p < 0.01 ) .
RESULTS	Sedation associated with quetiapine XR treatment mediated an improvement in agitation [ assessed by the Positive and Negative Syndrome Scale-Excitement ( PANSS-EC ) subscale ] and a worsening in functional capacity [ assessed by the University of California-San Diego ( UCSD ) Performance-Based Skills Assessment-Brief Version ( UPSA-B ) total score ] ; these mediating relationships were not observed for the lurasidone or placebo treatment groups .
CONCLUSIONS	In this 6-week double-blind study , treatment with lurasidone 80 mg or 160 mg , administered once daily in the evening , was associated with a reduction in daytime sleepiness similar in magnitude to placebo , while quetiapine XR 600 mg/d was associated with a significant increase in daytime sleepiness , compared to both lurasidone dose groups and placebo .
CONCLUSIONS	Daytime sleepiness was associated with improvement in agitation and worsening in functional capacity for quetiapine XR , but not lurasidone or placebo-treated patients .

###24612447
BACKGROUND	Distal upper limb pain ( pain affecting the elbow , forearm , wrist , or hand ) can be non-specific , or can arise from specific musculoskeletal disorders .
BACKGROUND	It is clinically important and costly , the best approach to clinical management is unclear .
BACKGROUND	Physiotherapy is the standard treatment and , while awaiting treatment , advice is often given to rest and avoid strenuous activities , but there is no evidence base to support these strategies .
BACKGROUND	This paper describes the protocol of a randomised controlled trial to determine , among patients awaiting physiotherapy for distal arm pain , ( a ) whether advice to remain active and maintain usual activities results in a long-term reduction in arm pain and disability , compared with advice to rest ; and ( b ) whether immediate physiotherapy results in a long-term reduction in arm pain and disability , compared with physiotherapy delivered after a seven week waiting list period .
METHODS	Between January 2012 and January 2014 , new referrals to 14 out-patient physiotherapy departments were screened for potential eligibility .
METHODS	Eligible and consenting patients were randomly allocated to one of the following three groups in equal numbers : 1 ) advice to remain active , 2 ) advice to rest , 3 ) immediate physiotherapy .
METHODS	Patients were and followed up at 6 , 13 , and 26 weeks post-randomisation by self-complete postal questionnaire and , at six weeks , patients who had not received physiotherapy were offered it at this time .
METHODS	The primary outcome is the proportion of patients free of disability at 26 weeks , as determined by the modified DASH ( Disabilities of the Arm , Shoulder and Hand ) questionnaire.We hypothesise ( a ) that advice to maintain usual activities while awaiting physiotherapy will be superior than advice to rest the arm ; and ( b ) that fast-track physiotherapy will be superior to normal ( waiting list ) physiotherapy .
METHODS	These hypotheses will be examined using an intention-to-treat analysis .
CONCLUSIONS	Results from this trial will contribute to the evidence base underpinning the clinical management of patients with distal upper limb pain , and in particular , will provide guidance on whether they should be advised to rest the arm or remain active within the limits imposed by their symptoms .
BACKGROUND	Registered on http://www.controlled-trials.com ( reference number : ISRCTN79085082 ) .

###25512110
OBJECTIVE	This study evaluated the efficacy of a probiotic containing Bacillus toyonensis spores ( Toyocerin ( ) ) in postweaning piglets against enteric pathogens .
RESULTS	Seven hundred and ninety-two healthy weaning pigs of a commercial farrow-to-finish pig farm were used .
RESULTS	The negative control group fed without Toyocerin ( ) and two experimental groups fed similar to the negative control group , but supplemented with Toyocerin ( ) at t 500 mg kg ( -1 ) diet ( Toyocerin 500 group ) and 1000 mg kg ( -1 ) diet ( Toyocerin 1000 group ) , respectively .
RESULTS	No significant difference ( P > 0.05 ) in morbidity and mortality rate between groups was noticed .
RESULTS	The Toyocerin groups showed higher body weight ( P < 0.05 ) and lower feed conversion ratio compared to the negative control group .
RESULTS	Diarrhoea score was less in both Toyocerin groups than negative control group ( P < 0.05 ) .
RESULTS	Moreover , the use of Toyocerin ( ) at 1000 mg kg ( -1 ) diet resulted in higher average daily feed intake compared to other groups ( P < 0.05 ) , reduction of some enteric pathogens and increase of the number of lactic acid bacteria .
CONCLUSIONS	The use of Toyocerin ( ) in weaning pigs , especially at 1000 mg kg ( -1 ) diet , improved their health and growth performance .
CONCLUSIONS	This study shows that a feed additive containing B. toyonensis ( Toyocerin ( ) ) protects against enteric pathogens in postweaning piglets when fed this additive at a proper dose .
CONCLUSIONS	The use of Toyocerin ( ) at 1000 mg kg ( -1 ) diet resulted in higher average daily feed intake , decrease of some enteric pathogens and higher number of lactic acid bacteria .
CONCLUSIONS	The effect of the probiotic in other age groups remains to be established .

###24453924
BACKGROUND	Inhalation of thermal water with antioxidant properties is empirically used for COPD .
OBJECTIVE	To evaluate the effects of sulphurous thermal water ( reducing agents ) on airway oxidant stress and clinical outcomes in COPD .
METHODS	Forty moderate-to-severe COPD patients were randomly assigned to receive 12-day inhalation with sulphurous thermal water or isotonic saline .
METHODS	Patients were assessed for superoxide anion ( O2 ( - ) ) production in the exhaled breath condensate and clinical outcomes at recruitment , the day after the conclusion of the 12-day inhalation treatment , and one month after the end of the inhalation treatment .
RESULTS	Inhalation of reducing agents resulted in a significant reduction of O2 ( - ) production in exhaled breath condensate of COPD patients at the end of the inhalatory treatment and at followup compared to baseline .
RESULTS	A significant improvement in the COPD assessment test ( CAT ) questionnaire was shown one month after the end of the inhalatory treatment only in patients receiving sulphurous water .
CONCLUSIONS	Thermal water inhalation produced an in vivo antioxidant effect and improvement in health status in COPD patients .
CONCLUSIONS	Larger studies are required in order to evaluate whether inhalation of thermal water is able to modify relevant clinical outcomes of the disease ( the study was registered at clinicaltrial.gov-identifier : NCT01664767 ) .

###26014294
OBJECTIVE	The phase III BEYOND trial was undertaken to confirm in a Chinese patient population the efficacy seen with first-line bevacizumab plus platinum doublet chemotherapy in globally conducted studies .
METHODS	Patients age 18 years with locally advanced , metastatic , or recurrent advanced nonsquamous non-small-cell lung cancer ( NSCLC ) were randomly assigned to receive carboplatin ( area under the curve , 6 ) intravenously and paclitaxel ( 175 mg/m ( 2 ) ) intravenously ( CP ) on day 1 of each 3-week cycle , for six cycles , plus placebo ( Pl + CP ) or bevacizumab ( B+CP ) 15 mg/kg intravenously , on day 1 of each cycle , until progression , unacceptable toxicity , or death .
METHODS	The primary end point was progression-free survival ( PFS ) ; secondary end points were objective response rate , overall survival , exploratory biomarkers , safety .
RESULTS	A total of 276 patients were randomly assigned , 138 to each arm .
RESULTS	PFS was prolonged with B+CP versus Pl + CP ( median , 9.2 v 6.5 months , respectively ; hazard ratio [ HR ] , 0.40 ; 95 % CI , 0.29 to 0.54 ; P < .001 ) .
RESULTS	Objective response rate was improved with B+CP compared with Pl + CP ( 54 % v 26 % , respectively ) .
RESULTS	Overall survival was also prolonged with B+CP compared with Pl + CP ( median , 24.3 v 17.7 months , respectively ; HR , 0.68 ; 95 % CI , 0.50 to 0.93 ; P = .0154 ) .
RESULTS	Median PFS was 12.4 months with B+CP and 7.9 months with Pl + CP ( HR , 0.27 ; 95 % CI , 0.12 to 0.63 ) in EGFR mutation-positive tumors and 8.3 and 5.6 months , respectively ( HR , 0.33 ; 95 % CI , 0.21 to 0.53 ) , in wild-type tumors .
RESULTS	Safety was similar to previous studies of B+CP in NSCLC ; no new safety signals were observed .
CONCLUSIONS	The addition to bevacizumab to carboplatin/paclitaxel was well tolerated and resulted in a clinically meaningful treatment benefit in Chinese patients with advanced nonsquamous NSCLC .

###25194966
OBJECTIVE	The aim of this study was to assess the effects of the Dietary Approaches to Stop Hypertension ( DASH ) diet on lipid profiles and biomarkers of oxidative stress in overweight and obese women with polycystic ovary syndrome ( PCOS ) .
METHODS	This randomized controlled clinical trial was conducted with 48 women diagnosed withPCOS .
METHODS	The women were randomly assigned to consume either the control ( n = 24 ) or DASH diet ( n = 24 ) for 8 wk .
METHODS	Both diets were designed to be calorie-restricted .
METHODS	Both diets consisted of 52 % carbohydrates , 18 % proteins , and 30 % total fats .
METHODS	The DASH diet was designed to be rich in fruits , vegetables , whole grains , and low-fat dairy products and to be low in saturated fats , cholesterol , and refined grains .
METHODS	Fasting blood samples were taken at baseline and after 8-wk intervention to measure lipid profiles and biomarkers of oxidative stress including plasma total antioxidant capacity ( TAC ) and total glutathione ( GSH ) .
RESULTS	Adherence to the DASH diet , compared with the control diet , resulted in a significant decrease in weight ( -4.4 versus -1.5 kg ; P < 0.001 ) and body mass index ( -1.7 versus -0.6 kg/m ( 2 ) ; P < 0.001 ) , decreased serum triglycerides ( -10.0 versus +19.2 mg/dL ; P interaction = 0.005 ) and very-low-density lipoprotein cholesterol levels ( -2.0 versus +3.9 mg/dL ; P interaction = 0.005 ) .
RESULTS	Increased concentrations of TAC ( +98.6 versus -174.8 mmol/L ; P interaction < 0.001 ) and GSH ( +66.4 versus -155.6 mol/L ; P interaction = 0.005 ) also were found in the DASH group compared with the control group .
CONCLUSIONS	Consumption of DASH diet for 8 wk led to a significant reduction in serum insulin , triglycerides and very-low-density lipoprotein cholesterol and a significant increase in TAC and GSH levels .

###26017787
OBJECTIVE	To describe the implementation process of a birth preparation program , the activities in the protocol for physical and birth preparation exercises , and the educational activities that have been evaluated regarding effectiveness and women 's satisfaction .
OBJECTIVE	The birth preparation program described was developed with the following objectives : to prevent lumbopelvic pain , urinary incontinence and anxiety ; to encourage the practice of physical activity during pregnancy and of positions and exercises for non-pharmacological pain relief during labor ; and to discuss information that would help women to have autonomy during labor .
METHODS	The program comprised the following activities : supervised physical exercise , relaxation exercises , and educational activities ( explanations of lumbopelvic pain prevention , pelvic floor function , labor and delivery , and which non-pharmacological pain relief to use during labor ) provided regularly after prenatal consultations .
METHODS	These activities were held monthly , starting when the women joined the program at 18-24 weeks of pregnancy and continuing until 30 weeks of pregnancy , fortnightly thereafter from 31 to 36 weeks of pregnancy , and then weekly from the 37th week until delivery .
METHODS	Information and printed materials regarding the physical exercises to be performed at home were provided .
METHODS	Clinicaltrials.gov : NCT01155804 .
RESULTS	The program was an innovative type of intervention that systematized birth preparation activities that were organized to encompass aspects related both to pregnancy and to labor and that included physical , educational and home-based activities .
CONCLUSIONS	The detailed description of the protocol used may serve as a basis for further studies and also for the implementation of birth preparation programs within the healthcare system in different settings .

###24335582
OBJECTIVE	Hemodialysis ( HD ) patients are educated and counseled during the HD procedure .
OBJECTIVE	There are few studies assessing whether cognitive performance varies with dialysis .
METHODS	Using a randomized cross-over design , 40 patients were assigned to one of two sequences : testing 1 h before dialysis followed 1 month later by testing during the first hour of dialysis ( n = 21 ) versus testing during the first hour of dialysis followed 1 month later by 1 h before dialysis ( n = 19 ) .
METHODS	Cognitive tests were administered at each testing period .
METHODS	Mixed regression models evaluated for a dialysis effect ( difference between test performance before vs. during dialysis ) while adjusting for potential learning ( difference between first and second tests ) .
RESULTS	In models accounting for period of testing , there was no difference in test performance between 1 h before versus during the first hour of HD for all administered cognitive tests ( p > 0.05 ) .
RESULTS	A learning effect was detected between first and second test administration in two tests , specifically , the Word List Learning and the Digit Symbol Substitution Test .
CONCLUSIONS	We found no difference in cognitive performance depending on the time of testing , suggesting that cognitive tests performed during the first hour of dialysis are a valid assessment of cognitive performance .

###25445550
OBJECTIVE	Increases to radiotherapy dose are constrained by normal tissue effects .
OBJECTIVE	The relationship between bowel dose volume data and late bowel toxicity in patients with muscle-invasive bladder cancer treated with radical radiotherapy was assessed .
METHODS	The bowel was contoured retrospectively on radiotherapy plans of 47 patients recruited to the BC2001 trial ( CRUK/01/004 ) .
METHODS	The relationship between bowel volume at various dose levels and prospectively collected late bowel toxicity was explored .
RESULTS	Fifteen per cent and 6 % of patients experienced grade 1 and grade 2 or more late bowel toxicity , respectively .
RESULTS	The mean bowel volume was significantly less at doses 50 Gy in those treated with reduced high dose volume radiotherapy compared with standard radiotherapy .
RESULTS	The probability of late bowel toxicity increased as bowel volume increased ( P 0.05 for dose levels 30-50 Gy ) .
RESULTS	No grade 2 or more late bowel toxicity was observed in patients with bowel volumes under the thresholds given in the model that predict for 25 % probability of late bowel toxicity .
CONCLUSIONS	There is a dose volume effect for late bowel toxicity in radical bladder radiotherapy .
CONCLUSIONS	We have modelled the probability of late bowel toxicity from absolute bowel volumes to guide clinicians in assessing radical bladder radiotherapy plans .
CONCLUSIONS	Thresholds predicting for a 25 % probability of late bowel toxicity are proposed as dose volume constraints .

###24322005
BACKGROUND	Questions remain regarding the consequences of illicit drug use on adolescent adjustment and the nature of mechanisms that may explain these consequences .
BACKGROUND	In this study , we examined whether early-onset illicit drug use predicts subsequent academic and psychosocial adjustment and whether associations are socially-mediated by decreased school engagement and increased peer deviancy .
METHODS	4885 adolescents were followed throughout secondary school .
METHODS	We used regressions to determine whether illicit drug use in grade 7 predicted academic achievement , school dropout , depressive symptoms , and conduct problems in grades 10-11 , adjusting for potential confounders .
METHODS	We used path analysis to test whether significant associations were mediated by school engagement and peer deviancy in grade 8 .
RESULTS	Illicit drug use predicted conduct problems and school dropout , but not academic achievement and depressive symptoms .
RESULTS	The association between illicit drug use and conduct problems was fully mediated by increased peer deviancy .
RESULTS	The association between illicit drug use and school dropout was partially mediated by increased peer deviancy , but remained mostly direct .
RESULTS	No indirect association via decreased school engagement was found .
RESULTS	Examination of reverse pathways revealed that conduct problems and academic achievement in grade 7 predicted drug use in grades 10-11 .
RESULTS	These associations were mediated by peer deviancy and school engagement ( conduct problems only ) .
CONCLUSIONS	Adolescent illicit drug use influences the risk of school dropout and conduct problems in part by contributing to deviant peer affiliation .
CONCLUSIONS	Reciprocal social mediation characterizes the association between drug use and conduct problems .
CONCLUSIONS	A reverse mechanism best explains the association with academic achievement .

###25347696
OBJECTIVE	Cough is one of the most common reasons why children visit a health care professional .
OBJECTIVE	To compare the effect of a novel formulation of pasteurized agave nectar vs placebo and no treatment on nocturnal cough and the sleep difficulty associated with nonspecific acute cough in infants and toddlers .
METHODS	In this randomized clinical trial performed in 2 university-affiliated outpatient , general pediatric practices from January 28 , 2013 , through February 28 , 2014 , children 2 to 47 months old with nonspecific acute cough duration of 7 days or less were studied .
METHODS	Surveys were administered to parents on 2 consecutive days , the day of presentation ( when no medication had been given the prior evening ) and the next day ( when agave nectar , placebo , or no treatment had been administered to their child before bedtime ) according to a partially double-blind randomization scheme .
METHODS	A single dose of agave nectar , placebo , or no treatment administered 30 minutes before bedtime .
METHODS	Cough frequency , cough severity , cough bothersomeness , congestion severity , rhinorrhea severity , and cough effect on child and parent sleep .
RESULTS	Significant differences in symptom improvement were detected between the study groups ( P < .05 for all , except P = .06 for cough bothersomeness ) , with agave nectar and placebo proving to be superior to no treatment , but no significant differences for any outcome were found when comparing agave nectar against placebo .
CONCLUSIONS	In a comparison of agave nectar , placebo , and no treatment , a placebo effect was demonstrated , with no additional benefit offered by agave nectar .
CONCLUSIONS	Health care professionals should consider the potential benefits and costs when recommending a treatment with only a placebo effect for infants and toddlers with nonspecific acute cough .
BACKGROUND	clinicaltrials.gov Identifier : NCT01721395 .

###25407258
OBJECTIVE	Drug effects on the function of smell and taste are occasionally mentioned in prescription information however , most originate from anecdotal reports without even distinguishing between gustatory or olfactory deteriorations .
OBJECTIVE	This includes the antifungal fluconazole .
METHODS	In a randomized , placebo-controlled , double-blind , two-way crossover study , 12 healthy men and 9 healthy women ( age 26.8 3.7 years ) took oral doses of 400 mg fluconazole or placebo once daily for 8 days .
METHODS	Gustatory and olfactory functions were tested before and after the treatment using clinically validated tests ( `` Taste Strips '' and `` Sniffin ' Sticks '' , respectively ) .
RESULTS	Baseline taste scores of 12.3 2.2 and 12.5 1.7 for the fluconazole and placebo conditions , respectively , corresponded to normative values .
RESULTS	Similarly , baseline ( pretreatment ) composite olfactory TDI scores ( odor `` threshold discrimination identification '' ) of 35.0 3.2 and 35.7 4.3 for men and 34.8 4.2 and 35.5 2.8 for women during the fluconazole or placebo conditions , respectively , corresponded to normative values .
RESULTS	Neither gustation nor olfaction was significantly affected by the fluconazole treatment .
CONCLUSIONS	The present study provided a negative result regarding fluconazole effects contrasting , for example , with those of sildenafil in a comparatively powered study [ 1 ] .
CONCLUSIONS	Up to the tested dose of 400 mg/d , fluconazole does not have general and reproducible effects on taste and smell in healthy humans .
CONCLUSIONS	However , it was unlikely to detect rare disturbances with the present study cohort size , and , therefore , rare fluconazole side effects on human chemosensation , as occasionally reported , remain a possibility .

###25488946
OBJECTIVE	To assess the efficacy and safety of latanoprostene bunod ( LBN ) compared with latanoprost 0.005 % , and to determine the optimum drug concentration ( s ) of LBN in reducing intraocular pressure ( IOP ) in subjects with open angle glaucoma or ocular hypertension .
METHODS	Randomised , investigator-masked , parallel-group , dose-ranging study .
METHODS	Subjects instilled one drop of study medication in the study eye once daily each evening for 28days and completed five study visits .
METHODS	The primary efficacy endpoint was the reduction in mean diurnal IOP at Day 28 .
RESULTS	Of the 413 subjects randomised ( LBN 0.006 % , n = 82 ; LBN 0.012 % , n = 85 ; LBN 0.024 % , n = 83 ; LBN 0.040 % , n = 81 ; latanoprost , n = 82 ) , 396 subjects completed the study .
RESULTS	Efficacy for LBN was dose-dependent reaching a plateau at 0.024 % -0.040 % .
RESULTS	LBN 0.024 % led to significantly greater reductions in diurnal IOP compared with latanoprost at the primary endpoint , Day 28 ( p = 0.005 ) , as well as Days 7 ( p = 0.033 ) and 14 ( p = 0.015 ) .
RESULTS	The incidence of adverse events , mostly mild and transient , was numerically higher in the LBN treatment groups compared with the latanoprost group .
RESULTS	Hyperaemia was similar across treatments .
CONCLUSIONS	LBN 0.024 % dosed once daily was the lower of the two most effective concentrations evaluated , with significantly greater IOP lowering and comparable side effects relative to latanoprost 0.005 % .
CONCLUSIONS	LBN dosed once daily for 28days was well tolerated .
BACKGROUND	NCT01223378 .

###24747467
BACKGROUND	Injury is the number one cause of death and disability in children in the United States and an increasingly important public health problem globally .
BACKGROUND	While prevention of injuries is an important goal , prevention efforts are currently fragmented , poorly funded , and rarely studied .
BACKGROUND	Among school-aged children , pedestrian crashes are a major mechanism of injury .
BACKGROUND	We hypothesized that we could develop a game-based educational tool that would be effective in teaching elementary school children the principles of pedestrian safety .
METHODS	Between November 2011 and June 2013 , second - and third-grade children in Los Angeles Unified School District were randomly assigned to play a unique interactive video game ( Ace 's Adventure ) about pedestrian safety or to a traditional didactic session about pedestrian safety .
METHODS	A pretest and posttest were administered to the study participants .
METHODS	Afterward , study participants were observed for appropriate pedestrian behavior on a simulated street set called Street Smarts .
METHODS	All statistical analyses were performed using SAS version 9.2 .
RESULTS	A total of 348 study participants took the pretest and posttest .
RESULTS	There were 180 who were randomized to the didactic and 168 who were randomized to the video game .
RESULTS	The didactic group demonstrated a higher mean score increase ( 1.01 , p < 0.0001 ) as compared with the video game group ( 0.44 , p < 0.0001 ) .
RESULTS	However , observation of study participants revealed that participants who played the video game , as compared with the didactic group , more frequently exhibited appropriate behavior during the following : exiting a parked car ( p = 0.01 ) , signaling to a car that was backing up ( p = 0.01 ) , signaling to a stopped car ( p = 0.0002 ) , and crossing the street ( p = 0.01 ) .
CONCLUSIONS	Students who played the educational video game about pedestrian safety performed similarly to those who attended a more traditional and labor-intensive didactic learning .
CONCLUSIONS	Innovative educational methods , such as game playing , could significantly change our approach to injury prevention and have the potential to decrease the burden of injury among children worldwide .

###24843060
BACKGROUND	Little is known about duration of protection after the infant primary series of hepatitis B ( HB ) vaccine in settings of low HB endemicity .
BACKGROUND	This study sought to determine the proportion of adolescents immunized as infants who had protective titers of antibody to hepatitis B surface antigen ( anti-HBs ) before and after a challenge dose of vaccine .
METHODS	US-born 16 - through 19-year-olds who received a recombinant HB vaccine 3-dose series initiated within 7 days of birth ( group 1 ) or at 4 weeks of age ( group 2 ) and completed by 12 months of age were enrolled .
METHODS	Participants had serologic testing before and 2 weeks after randomization to receive a challenge dose of 10 g or 20 g of Engerix-B .
METHODS	Baseline and postchallenge levels of anti-HBs were compared by group , challenge dosage , and demographic and behavioral characteristics .
RESULTS	At baseline , 24 % had protective anti-HBs levels of 10 IU/mL ; 92 % achieved protective levels after challenge dose .
RESULTS	Although group 1 had a lower proportion of seroprotection at baseline , group and challenge dosage were not associated with postchallenge proportion of seroprotection .
RESULTS	Being in group 2 , higher test dosage , higher baseline geometric mean titer , and nonwhite race were associated with significantly higher geometric mean titer after challenge dose .
CONCLUSIONS	More than 90 % of study participants immunized against HB as infants exhibited a seroprotective response to a challenge dose of vaccine .
CONCLUSIONS	Duration of protection from the primary infant HB vaccine series extended through the adolescent years in the setting of low HB endemicity .

###24862386
OBJECTIVE	To investigate the accuracy of measuring intraocular pressure over a silicone hydrogel contact lens using Goldmann applanation tonometry in eyes with glaucoma .
METHODS	This was a prospective , randomized study and enrolled 28 patients ( 28 right eyes ) with primary open angle glaucoma .
METHODS	Intraocular pressure was taken with and without a silicone hydrogel contact lens ( -0.50 D ) , in situ ( using Goldmann applanation tonometry ) , in a randomized order of measurements .
METHODS	Statistical analysis was performed using paired t-test and Bland-Altman plot .
RESULTS	The mean difference ( standard deviation ) found between intraocular pressure measurement without ( mean 16.7 3.2 mmHg ) and with ( mean 17.3 3.0 mmHg ) contact lens was found to be -0.57 2.3 mmHg ( 95 % confidence interval , -1.5 to 0.3 ) .
RESULTS	No significant statistical difference was found between the two groups with paired t-test ( p = 0.19 ) .
RESULTS	The Bland Altman plot showed some evidence of increasing variability of differences between two measures of intraocular pressure , with increasing intraocular pressure .
RESULTS	The 95 % limits of agreement of the Bland Altman plot were unacceptably large ( -5 mmHg to 3.9 mmHg ) .
CONCLUSIONS	Agreement between Goldmann applanation tonometry with and without contact lenses seems to be poor in patients with glaucoma , especially for high intraocular pressure .

###24385236
OBJECTIVE	8-Hydroxy-2 ,2,14,14 - tetramethylpentadecanedioic acid ( ETC-1002 ) is a small molecule with a unique mechanism of action shown in nonclinical studies to modulate pathways of cholesterol , fatty acid , and carbohydrate metabolism .
OBJECTIVE	In previous phase 2 clinical trials , once daily oral treatment with ETC-1002 significantly reduced low-density lipoprotein-cholesterol in patients with hypercholesterolemia .
OBJECTIVE	In this trial , the lipid-lowering efficacy of ETC-1002 was evaluated in patients with type 2 diabetes mellitus and hypercholesterolemia .
OBJECTIVE	Additional cardiometabolic biomarkers , including glycemic measures , were also assessed .
RESULTS	A single-center , double-blind , placebo-controlled trial evaluated 60 patients with type 2 diabetes mellitus and elevated low-density lipoprotein-cholesterol .
RESULTS	Patients discontinued all diabetes mellitus and lipid-regulating drugs and were randomized to receive ETC-1002 80 mg QD for 2 weeks followed by 120 mg QD for 2 weeks or placebo for 4 weeks .
RESULTS	ETC-1002 lowered low-density lipoprotein-cholesterol levels by 432.6 % ( least squares meanSE ) , compared with a reduction of 42.5 % by placebo at day 29 ( P < 0.0001 ; primary end point ) .
RESULTS	Non-high-density lipoprotein-cholesterol and total cholesterol were also significantly lowered by ETC-1002 compared with placebo ( P < 0.0001 ) .
RESULTS	High-sensitivity C-reactive protein was reduced by 41 % ( median ) compared with a placebo reduction of 11 % ( P = 0.0011 ) .
RESULTS	No clinically meaningful safety findings were observed .
CONCLUSIONS	ETC-1002 lowered low-density lipoprotein-cholesterol and other lipids and demonstrated improvement in high-sensitivity C-reactive protein in patients with type 2 diabetes mellitus and hypercholesterolemia without worsening glycemic control .
CONCLUSIONS	ETC-1002 was well tolerated in this population .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT # 01607294 .

###24868583
OBJECTIVE	To evaluate the therapeutic effect of topical unoprostone isopropyl ( unoprostone ) on patients with retinitis pigmentosa ( RP ) .
METHODS	Forty patients with typical forms of RP were included in the study.Seventeen of 40 patients were treated with 0.12 % topical unoprostone twice daily in a randomly selected eye .
METHODS	Patients underwent follow-up examinations every 3 months after treatment .
METHODS	The efficacy of the treatment was monitored by visual acuity and visual field measurement testing using the Humphrey Field Analyzer ( HFA : the central 10-2 programme ) .
METHODS	Moreover , 12 RP patients who were included this study and 12 normal subjects were evaluated in terms of their macular blood flow of both eyes after instillation of unoprostone using the laser speckle method .
RESULTS	One year after treatment , the ` macular sensitivity ' , calculated by HFA as the average sensitivity of the central 12 points , was preserved in the fellow eyes as well as the unoprostone-treated eyes .
RESULTS	On the other hand , that in the eyes of the control RP patient was significantly decreased .
RESULTS	Moreover , there were significantly greater improvements of the ` macular sensitivity ' in the unoprostone-treated eyes than the fellow eyes .
RESULTS	The change ratios of macular blood flow obtained from both RP patients and normal subjects were significantly increased in both the treated and the fellow eyes .
RESULTS	No severe side-effects were observed .
CONCLUSIONS	These results demonstrate that topical unoprostone might have a therapeutic efficacy in patients with RP as a consequence of the macular bloodflow improvement as well as its direct neuroprotective effect .

###24559811
OBJECTIVE	Ginger is one of the most commonly used herbal medicines for irritable bowel syndrome ( IBS ) but no data exists about its effectiveness .
METHODS	Double blind randomized controlled trial .
METHODS	University of North Carolina , Chapel Hill , North Carolina , USA .
METHODS	Forty-five IBS patients were randomly assigned to three groups : placebo , 1g of ginger , and 2g of ginger daily for 28 days .
METHODS	The IBS severity scale ( IBS-SS ) was administered , as well as adequate relief of symptoms scale .
METHODS	A responder was defined as having at least 25 % reduction in IBS-SS post-treatment .
RESULTS	There were 57.1 % responders to placebo , 46.7 % to 1g and 33.3 % to 2g of ginger .
RESULTS	Adequate relief was reported by 53.3 % on placebo and 53.3 % in both ginger groups combined .
RESULTS	Side effects were mild and reported by 35.7 % in the placebo and 16.7 % in the ginger groups .
CONCLUSIONS	This double blind randomized controlled pilot study suggests ginger is well tolerated but did not perform better than placebo .
CONCLUSIONS	Larger trials are needed before any definitive conclusions can be drawn .

###26013537
BACKGROUND	The aim of this study was to conduct a cluster randomized control trial to assess the efficacy of screening and brief intervention ( SBI ) for conjoint alcohol and tobacco use among hospital out-patients .
METHODS	In all 620 hospital out-patients who screened positive for both tobacco and alcohol moderate risk in four hospitals were randomized into 2 control and 1 intervention condition using the hospital as a unit of randomization ( 2 intervention and 2 control hospitals ) to 405 patients in the two control groups ( tobacco only intervention , n = 199 , and alcohol only intervention , n = 206 ) and 215 in the intervention group .
METHODS	The intervention or control consisted of three counselling sessions .
RESULTS	Results of the interaction ( GroupTime ) effects using GEE indicated that there were statistically significant differences between the three study groups over the 6-month follow-up on the ASSIST tobacco score ( Wald ( 2 ) = 8.43 , P = 0.004 ) , and past week tobacco use abstinence ( Wald ( 2 ) = 7.34 , P = 0.007 ) .
RESULTS	Although there were no significant interaction effects on the other outcomes ( Alcohol ASSIST score , low alcohol risk score , past week tobacco abstinence or low alcohol risk score , and past week tobacco abstinence and low alcohol risk score ) , the scores in all of the six outcome measures showed consistent improvements .
RESULTS	For past week tobacco abstinence the tobacco only intervention was more effective than the alcohol only intervention and the integrated alcohol and tobacco intervention .
RESULTS	For the outcome of low alcohol risk , the alcohol only intervention and the integrated alcohol and tobacco intervention was more effective than the tobacco only or alcohol only intervention .
CONCLUSIONS	The study found that for past week tobacco abstinence the tobacco only intervention was more effective than the alcohol only intervention and the polydrug use ( alcohol and tobacco ) integrated intervention .

###24343683
OBJECTIVE	To compare the effects of two physical therapy exercise in-hospital programs in pulmonary function and functional capacity of patients in the postoperative period of heart transplantation .
METHODS	Twenty-two heart transplanted patients were randomized to the control group ( CG , n = 11 ) and training group ( TG , n = 11 ) .
METHODS	The control group conducted the exercise program adopted as routine in the institution and the training group has had a protocol consisting of 10 stages , with incremental exercises : breathing exercises , resistance training , stretching and walking .
METHODS	The programs began on the first day after extubation and stretched until hospital discharge .
METHODS	Assessed pulmonary function , distance walked in six minutes walk test ( 6MWT ) and peripheral muscle strength by one repetition maximum test ( 1RM ) .
RESULTS	Similar behavior was observed between the two groups treated , with statistically significant increases between the first and second test of the following variables : FVC ( 59 % in CG and 35.2 % in TG ) ; MIP ( 8.6 % in CG and 53.5 % in TG ) , MEP ( 28.8 % in CG and 40.7 % in TG ) and 6MWT ( 44.5 % in CG and 31.4 % in TG ) .
RESULTS	There was an increase of peripheral strength by 1RM test , over time , to the muscle groups of the elbow flexors , shoulder flexors , hip abductors and knee flexors .
CONCLUSIONS	Heart transplant patients benefit from exercise programs in hospital , regardless of the program type applied .
CONCLUSIONS	A new training proposal did not result in superiority compared to routine programme applied .
CONCLUSIONS	Exercise protocols provided improves in ventilatory variables and functional capacity of this population .

###24995488
OBJECTIVE	Chronic neck/shoulder pain ( CNSP ) is one of the most common pain conditions .
OBJECTIVE	The understanding of mechanisms , including the peripheral balance between nociceptive and antinociceptive processes , is incomplete .
OBJECTIVE	N-acylethanolamines ( NAEs ) are a class of endogenous compounds that regulate inflammation and pain .
OBJECTIVE	The aim of this study was to investigate the levels of two NAEs : the peroxisome proliferator-activated receptor type - ligand palmitoylethanolamide ( PEA ) and stearoylethanolamide ( SEA ) in the muscle interstitium of the trapezius muscle in women with CNSP randomized to two different neck specific training programs and in a healthy pain-free control group ( CON ) .
METHODS	Fifty-seven women with CNSP were randomized to strength + stretch or stretch alone exercise programs .
METHODS	Twenty-nine subjects underwent microdialysis procedure before and after 4-6 months of exercise .
METHODS	Twenty-four CON subjects underwent microdialysis procedure before and after 4-6 months without any intervention in between .
METHODS	Microdialysate samples were collected from the trapezius muscle and analyzed by mass spectrometry for PEA and SEA levels .
RESULTS	PEA and SEA levels were significantly higher in CNSP patients compared with CON .
RESULTS	PEA was significantly higher in CNSP than in CON after both training programs .
RESULTS	SEA was significantly higher in CNSP than in CON after stretch alone but not after strength + stretch training .
RESULTS	A significant positive correlation was found between changes in pain intensity and in SEA levels in the strength + stretch group , but not in the stretch alone group .
CONCLUSIONS	Our results indicate that exercise interventions differentially affect the levels of the bioactive lipids PEA and SEA in the interstitium of the trapezius muscle in women with CNSP .

###24696507
OBJECTIVE	To examine safety , tolerability , and efficacy of PF-04494700 , an inhibitor of the receptor for advanced glycation end products ( RAGE ) , in mild to moderate Alzheimer disease ( AD ) .
METHODS	Double-blind , placebo-controlled trial at 40 academic centers ( United States ) .
METHODS	Subjects with AD and Mini-Mental State Examination score 14-26 were randomized to PF-04494700 60 mg/day 6 days , then 20 mg daily ( high dose ) ; 15 mg/day 6 days , then 5 mg daily ( low dose ) ; or placebo , for 18 months .
METHODS	Clinical and laboratory measures were used to evaluate safety and tolerability .
METHODS	The primary efficacy measure was the Alzheimer 's Disease Assessment Scale-cognitive ( ADAS-cog ) .
METHODS	Secondary measures assessed clinical stage , function , behavior , MRI , and CSF biomarkers .
RESULTS	A total of 399 subjects were randomized .
RESULTS	In a prespecified interim analysis , when 50 % of subjects had completed the 6-month visit , the high dose was associated with confusion , falls , and greater ADAS-cog decline and was discontinued .
RESULTS	A second prespecified analysis compared low-dose and placebo groups for futility and safety approximately 12 months after all subjects were randomized .
RESULTS	This analysis met criteria for futility , and treatment was discontinued .
RESULTS	There were no safety concerns in the low-dose group .
RESULTS	Analyses including post-futility data showed decreased decline on the ADAS-cog in the low-dose group at month 18 .
RESULTS	Other clinical and biomarker measures showed no differences between low-dose treatment and placebo .
CONCLUSIONS	PF-04494700 at 20 mg/d was associated with increased adverse events and cognitive decline .
CONCLUSIONS	At 5 mg/d , PF-04494700 had a good safety profile .
CONCLUSIONS	A potential benefit for this low dose on the ADAS-cog is not conclusive , because of high dropout and discontinuation rates subsequent to the interim analyses .
METHODS	This study provides Class I evidence that in patients with AD high-dose PF-04494700 increased cognitive decline at 6 months and Class IV evidence that low-dose PF-04494700 slowed cognitive decline at 18 months .

###24709491
OBJECTIVE	To investigate the effects of trimetazidine on renal function in patients with shock .
METHODS	A prospective randomized controlled double-blind study was conducted .
METHODS	128 patients with shock admitted to intensive care unit ( ICU ) of Guangzhou Red Cross Hospital from April 2011 to April 2013 were enrolled and randomly divided into control group and trimetazidine treatment group , each n = 64 .
METHODS	All patients received anti-shock treatment , while the patients in trimetazidine group received trimetazidine treatment ( 20 mg orally , tid ) for 7 days , and patients in control group received placebo ( 10 mL of sterile water for injection , tid ) for 7 days .
METHODS	The urinary output , serum creatinine ( SCr ) , blood urea nitrogen ( BUN ) , cystatin C , and creatinine clearance ( CCr ) reflecting renal function were recorded in both groups , and the values were compared before treatment , 48 hours after treatment , and 1 week after the treatment .
METHODS	At the same time , dynamic mean arterial pressure ( MAP ) was monitored , and 48-hour and 1-week mortality rates were recorded .
RESULTS	There was no significant difference in results in all the renal function parameters before the treatment between two groups .
RESULTS	The levels of SCr , BUN , cystatin C were gradually decreased after treatment in both groups , but CCr and MAP were gradually increased .
RESULTS	Compared with the control group , cystatin C at 48 hours after treatment was significantly decreased , while CCr was significantly increased in treatment group ( cystatin C : 0.850.81 mg/L vs. 1.010.91 mg/L , t = 2.562 , P = 0.017 ; CCr : 0.930.64 mL/s vs. 0.690.40 mL/s , t = 2.155 , P = 0.033 ) .
RESULTS	SCr and BUN at 1 week after treatment were significantly decreased in treatment group ( SCr : 94.2388.31 mol/L vs. 104.9998.37 mol/L , t = 2.921 , P = 0.003 ; BUN : 9.468.24 mmol/L vs. 11.878.65 mmol/L , t = 2.611 , P = 0.010 ) .
RESULTS	Urine output per hour and MAP was improved after treatment in both groups , and no significant difference was found between treatment group and control group ( urine output : 48 hours after treatment 55.6731.43 mL vs. 45.3411.79 mL , t = 0.934 , P = 0.323 ; 1 week after treatment 71.6737.23 mL vs. 75.3522.88 mL , t = 1.280 , P = 0.210 ; MAP : 48 hours after treatment 72.1333.24 mmHg vs. 69.2839.98 mmHg , t = 1.408 , P = 0.179 ; 1 week after treatment 71.4421.98 mmHg vs. 72.3231.11 mmHg , t = 1.184 , P = 0.252 ] .
RESULTS	Mortality rate in treatment group was lowered compared with control group , however no statistical significance was found [ 48 hours after treatment : 31.2 % ( 20/64 ) vs. 32.8 % ( 21/64 ) , 2 = 0.084 , P = 0.785 ; 1 week after treatment : 32.8 % ( 21/64 ) vs. 35.9 % ( 23/64 ) , 2 = 2.084 , P = 0.173 ] .
CONCLUSIONS	Trimetazidine can improve renal function in patients with shock .

###24527444
BACKGROUND	The aim of this study is to compare the effects of sevoflurane and propofol on one lung ventilation ( OLV ) induced ischemia-reperfusion injury ( IRI ) by determining the blood gas , ischemia-modified albumin ( IMA ) , and malonyldialdehyde ( MDA ) .
METHODS	Forty-four patients undergoing thoracic surgery with OLV were randomized in two groups ( sevoflurane Group S , propofol Group P ) .
METHODS	Anesthesia was inducted with thiopental and was maintained with 1-2 .5 % of sevoflurane within the 40/60 % of O2/N2O mixture in Group S.
METHODS	In Group P anesthesia was inducted with propofol and was maintained with infusion of propofol and remifentanil .
METHODS	Hemodynamic records and blood samples were obtained before anesthesia induction ( t 1 ) , 1 min before two lung ventilation ( t 2 ) , 30 min after two lung ventilation ( t 3 ) , and postoperative sixth hours ( t 4 ) .
RESULTS	Heart rate at t 2 and t 3 in Group P was significantly lower than that in Group S.
RESULTS	While there were no significant differences in terms of pH and pCO2 , pO2 at t 2 and t 3 in Group S was significantly lower than that in Group P. IMA levels at t 4 in Group S were significantly lower than those in Group P.
CONCLUSIONS	Sevoflurane may offer protection against IRI after OLV in thoracic surgery .

###24498399
OBJECTIVE	The Low Molecular Weight Fraction of 5 % human serum Albumin ( LMWF-5A ) is being investigated as a treatment for knee pain from osteoarthritis .
METHODS	This was a multicenter randomized , vehicle-controlled , double-blind , parallel study designed to evaluate the safety and efficacy of two doses of an intra-articular injection of LMWF-5A .
METHODS	Patients with symptomatic knee osteoarthritis were randomized 1111 to receive a single 4 mL or 10 mL intra-articular knee injection of either LMWF-5A or vehicle control ( saline ) .
METHODS	The primary efficacy endpoint was the difference between treatment groups in the Western Ontario and McMaster Universities ( WOMAC ) pain change from baseline over 12 weeks .
METHODS	Safety was examined as the incidence and severity of adverse events ( AEs ) .
RESULTS	A total of 329 patients were randomized and received treatment .
RESULTS	LMWF-5A resulted in a significant decrease in pain at 12 weeks compared to vehicle control ( -0.93 vs -0.72 ; estimated difference from control : -0.25 , p = 0.004 ) ; an injection volume effect was not observed ( p = 0.64 ) .
RESULTS	The effect of LMWF-5A on pain was even more pronounced in patients with severe knee OA ( Kellgren Lawrence Grade IV ) : the estimated difference from control was -0.42 ( p = 0.02 ) .
RESULTS	Adverse events were generally mild and were similar in patients who received vehicle control ( 47 % ) and LMWF-5A ( 41 % ) .
CONCLUSIONS	This clinical trial demonstrated that LMWF-5A is safe and effective at providing relief for the pain of moderate to severe OA of the knee over 12 weeks when administered by intra-articular injection into the knee .
BACKGROUND	ClinicalTrials.gov NCT01839331 .

###25022831
OBJECTIVE	Severe childhood obesity has become a major health problem , and effective , evidence-based interventions are needed .
OBJECTIVE	The relative effectiveness of inpatient compared with ambulatory treatment remains unknown .
OBJECTIVE	To determine whether an inpatient treatment program is more effective than an ambulatory treatment program at achieving a sustained weight loss in children and adolescents with severe obesity .
METHODS	We conducted a randomized clinical trial with a 2-year follow-up at a tertiary referral center for pediatric obesity in the Netherlands .
METHODS	We recruited 90 children and adolescents aged 8 to 18 years with severe obesity ( body mass index [ BMI ] z score , 3.0 or > 2.3 with obesity-related health problems ) .
METHODS	Patients were randomly assigned to an inpatient ( 6 months of hospitalization on working days ) or an ambulatory ( 12 days of hospital visits at increasing intervals during a 6-month period ) treatment program .
METHODS	Both treatment programs involved an intensive , family-based , lifestyle intervention , including exercise , nutritional education , and behavior modification for the patients and their caregiver ( s ) .
METHODS	Change in BMI z score .
METHODS	Secondary outcomes included fasting insulin , fasting plasma glucose , 2-hour plasma glucose , and lipid levels , insulin sensitivity , liver function test results , waist circumference , blood pressure , body composition , and aerobic fitness ( peak oxygen consumption , Vo ) .
METHODS	Outcomes were analyzed by intention to treat .
RESULTS	Immediately after treatment , reductions in the BMI z score were significantly larger for the inpatient than the ambulatory groups ( mean [ SE ] difference , -0.26 [ 0.12 ; 95 % CI , -0.59 to -0.01 ] ; P = .04 ) .
RESULTS	Change from baseline for the BMI z score in the inpatient group was -18.0 % ( P = .001 ) immediately after treatment , -8.5 % ( P = .008 ) at 18 months , and -6.3 % ( P = .38 ) at 30 months ; in the ambulatory group , changes from baseline were -10.5 % ( P = .001 ) , -6.2 % ( P = .39 ) , and -1.5 % ( P > .99 ) , respectively .
RESULTS	The favorable outcomes of the inpatient group could not be sustained at 12 and 24 months after treatment .
RESULTS	In addition , significant differences in favor of the inpatient group immediately after treatment were found for levels of fasting insulin ( -6.37 IU/L ; P = .02 ) , total cholesterol ( -19.51 mg/dL ; P = .01 ) , low-density lipoprotein cholesterol ( -13.48 mg/dL ; P = .03 ) , and triglycerides ( -25.39 mg/dL ; P = .01 ) , and insulin sensitivity ( -1.37 ; P = .02 ) , fat mass ( -3.31 % ; P = .03 ) , and peak Vo ( 378.2 mL/min ; P = .01 ) .
CONCLUSIONS	In severely obese children and adolescents , inpatient treatment was superior to ambulatory treatment immediately after treatment , but effects were not sustained at long-term follow-up .
CONCLUSIONS	These findings stress the need to further study maintenance strategies for sustainable weight loss .
BACKGROUND	trialregister.nl Identifier : NTR1172 .

###24735005
OBJECTIVE	To determine the efficacy of topical ketorolac tromethamine in preventing cystoid macular edema ( CME ) after uncomplicated cataract surgery .
METHODS	This single-center , prospective , double-masked , randomized clinical trial consisted of 81 patients who were scheduled for cataract surgery .
METHODS	Patients were randomized to receive hypromellose/dextran 70 as a placebo ( n = 44 ) or ketorolac tromethamine 0.4 % ( n = 37 ) as an adjuvant therapy .
METHODS	These eye drops were administered 4 times daily ( QID ) for 3 days before surgery and 5 weeks postoperatively .
METHODS	All patients received prednisolone acetate 1 % QID during the same period as basal/standard anti-inflammatory therapy .
METHODS	The primary outcome was the incidence of angiographic CME 5 weeks after surgery .
METHODS	The secondary outcomes were mean change in best-corrected visual acuity ( BCVA ) [ Early Treatment Diabetic Retinopathy study ( ETDRS ) ] , clinical CME incidence , intraocular pressure , and retinal thickness measured using optical coherence tomography ( OCT ) .
RESULTS	In the placebo group , 2/44 ( 4.5 % ) patients and in the ketorolac group , 2/37 ( 5.4 % ) patients presented with angiographic CME ( P = 0.624 ) .
RESULTS	The mean change in postoperative BCVA was 3215 letters in the placebo group and 2616 letters in the ketorolac group ( P = 0.07 ) .
RESULTS	There were no statistically significant between-group differences in the mean central subfield thickness ( P = 0.679 ) , minimal central thickness ( P = 0.352 ) , or central macular volume ( P = 0.729 ) .
CONCLUSIONS	There was no difference between ketorolac tromethamine and a placebo with regard to BCVA results or prevention of CME after uncomplicated cataract surgery .

###26206641
BACKGROUND	Several pre - and intraoperative factors have been associated with incisional surgical site infection ( SSI ) , but little is known about the influence of postoperative wound care and especially , the use of different dressings on incisional SSI .
BACKGROUND	The aim of this study was to compare 3 methods of wound dressings ( conventional dressing , silver-containing dressing , and mupirocin ointment dressing ) for their ability to prevent SSI , as measured by SSI rates , in patients with colorectal cancer undergoing elective open surgery .
METHODS	A prospective , randomized study was performed .
METHODS	Inclusion criteria were diagnosis of colorectal neoplasms and plans to undergo elective surgery with curative aims .
METHODS	Patients were randomized using a 1:1:1 allocation into 3 groups : patients receiving an ionic silver-containing dressing ( ISD ) ( group 1 ) , a mupirocin ointment application ( MOA ) ( group 2 ) , and a conventional dressing ( group 3 or standard dressing ) .
METHODS	The primary outcomes variable was occurrence of incisional SSI .
METHODS	Follow-up was 30 days postoperatively .
RESULTS	A total of 147 patients were included , 49 in each group .
RESULTS	Incisional SSI occurred in 9 patients ( 18.4 % ) in the ISD group , 2 ( 4.1 % ) in the MOA group , and 10 ( 20.4 % ) in the standard dressing group ( p = 0.028 ) .
RESULTS	Adjusting for multiple comparisons , there were no significant differences between ISD and standard dressing groups ; a significant difference was observed between ISD and MOA ( relative risk [ RR ] 4.5 ; 95 % CI ( 1.1 to 19.8 ) ; p = 0.046 ) and between the standard group and the MOA group ( RR 5 ; 95 % CI ( 1.2 to 21.7 ) ; p = 0.031 ) .
CONCLUSIONS	Topical application of mupirocin ointment achieves better results for the prevention of SSI than ionic silver-containing dressing or standard dressing in patients undergoing elective open colorectal surgery .

###24240577
OBJECTIVE	It is assumed that laparoscopic surgery generally induces less inflammatory responses than open surgery .
OBJECTIVE	Since few studies have compared immune responses after laparoscopic and open surgery in children , we examined inflammatory markers in children randomized to open ( ONF ) or laparoscopic Nissen fundoplication ( LNF ) .
METHODS	Blood samples were collected prior to surgery ( D0 ) , and on postoperative day 1 ( D1 ) and day 2 ( D2 ) .
METHODS	Inflammatory markers were measured using a multiplex antibody bead kit .
METHODS	The postoperative levels of inflammatory markers were statistically analyzed using a linear mixed model .
METHODS	A P value < 0.05 was considered statistically significant .
RESULTS	Twenty-nine patients randomized to ONF or LNF were included .
RESULTS	Median age was 3.1 years ( range 1.0-14 .2 ) in the ONF group and 4.0 years ( range 0.2-14 .2 ) in the LNF group .
RESULTS	Plasma levels of the anti-inflammatory cytokine interleukin ( IL ) -10 were significantly higher in the ONF group than in the LNF group postoperatively ( P = 0.04 ) .
RESULTS	However , there were no significant differences between the groups in the levels of pro-inflammatory markers tumor necrosis factor - , IL-6 , IL-8 , monocyte chemoattractant protein-1 , white blood cell count , or C-reactive protein .
CONCLUSIONS	We did not find that laparoscopy induced a substantially less inflammatory response than laparotomy in children undergoing fundoplication .

###24304987
OBJECTIVE	To assess the feasibility and efficacy of a novel , minimally invasive spinal surgery technique for the correction of lumbar spinal stenosis involving unilateral approach for bilateral decompression .
METHODS	Cross-sectional observational study .
METHODS	Neurosurgery Department of PGMI , Lady Reading Hospital , Peshawar , from January to December 2010 .
METHODS	A total of 60 patients with lumbar stenosis were randomly assigned to undergo either a conventional laminectomy ( 30 patients , Group A ) , or a unilateral approach ( 30 patients , Group B ) .
METHODS	Clinical outcomes was measured using the scale of Finneson and Cooper .
METHODS	All the data was collected by using a proforma and different parameters were assessed for a minimum follow-up period of three months .
METHODS	Data was analyzed by descriptive statistics using SPSS software version 17 .
RESULTS	Adequate decompression was achieved in all patients .
RESULTS	Compared with patients in the conventional laminectomy group , patients who received the novel procedure ( unilateral approach ) had a reduced mean duration of hospital stay , a faster recovery rate and majority of the patients ( 88.33 % ) had an excellent to fair operative result according to the Finneson and Cooper scale .
RESULTS	Five major complications occurred in all patient groups , 2 patients had unintended dural rent and 2 wound dehiscence each and fifth patient had worsening of symptoms .
RESULTS	There was no mortality in the series .
CONCLUSIONS	The ultimate goal of the unilateral approach to treat lumbar spinal stenosis is to achieve adequate decompression of the neural elements .
CONCLUSIONS	An additional benefit of a minimally invasive approach is adequate preservation of vertebral stability , as it requires only minimal muscle trauma , preservation of supraspinous/intraspinous ligament complex and spinous process , therefore , allows early mobilization .
CONCLUSIONS	This also shortens the hospital stay , reduces postoperative back pain , and leads to satisfactory outcome .

###24778393
OBJECTIVE	Fatigue is a distressing symptom occurring in more than 60 % of patients with cancer .
OBJECTIVE	The CNS stimulants modafinil and methylphenidate are recommended for the treatment of cancer-related fatigue , despite a limited evidence base .
OBJECTIVE	We aimed to evaluate the efficacy and tolerability of modafinil in the management of fatigue in patients with non-small-cell lung cancer ( NSCLC ) .
METHODS	Adults with advanced NSCLC and performance status of 0 to 2 , who were not treated with chemotherapy or radiotherapy within the last 4 weeks , were randomly assigned to daily modafinil ( 100 mg on days 1 to 14 ; 200 mg on days 15 to 28 ) or matched placebo .
METHODS	The primary outcome was change in Functional Assessment of Chronic Illness Therapy ( FACIT ) - Fatigue score from baseline to 28 days , adjusted for baseline fatigue and performance status .
METHODS	Secondary outcomes included safety and patient-reported measures of depression , daytime sleepiness , and quality of life .
RESULTS	A total of 208 patients were randomly assigned , and 160 patients ( modafinil , n = 75 ; placebo , n = 85 ) completed questionnaires at both baseline and day 28 and were included in the modified intention-to-treat analysis .
RESULTS	FACIT-Fatigue scores improved from baseline to day 28 ( mean score change : modafinil , 5.29 ; 95 % CI , 2.57 to 8.02 ; placebo , 5.09 ; 95 % CI , 2.54 to 7.65 ) , but there was no difference between treatments ( 0.20 ; 95 % CI , -3.56 to 3.97 ) .
RESULTS	There was also no difference between treatments for the secondary outcomes ; 47 % of the modafinil group and 23 % of the placebo group stated that the intervention was not helpful .
CONCLUSIONS	Modafinil had no effect on cancer-related fatigue and should not be prescribed outside a clinical trial setting .
CONCLUSIONS	Its use was associated with a clinically significant placebo effect .

###25566618
OBJECTIVE	To observe the clinical efficacy of Bushen Huoxue Sanyu Decoction ( BHSD ) in treatment of adenomyosis ( AM ) patients .
METHODS	Seventy AM patients of Shen deficiency blood stasis syndrome ( SDBSS ) were randomly assigned to two groups , the CM treatment group ( 50 cases ) and the Mirena group ( 20 cases ) .
METHODS	Patients in the CM treatment group were treated with BHSD , one dose per day .
METHODS	Levonorgestrel intrauterine system ( Mirena ) was placed in the uterine cavity of those in the Mirena group .
METHODS	The therapeutic course for all was 3 months .
METHODS	Changes of dysmenorrhea , menstrual quantity , SDBSS , CM syndrome , uterine volume , and serum CA125 levels were observed before and after treatment .
RESULTS	Compared with before treatment in the same group , scores for dysmenorrhea integral , scores for menstrual quantity , scores for SDBSS , and scores for CM syndrome all decreased in the two groups after treatment ( P < 0.01 ) .
RESULTS	Compared with before treatment in the same group , the uterine volume was reduced after treatment in the two groups ( P < 0.05 ) and serum carbohydrate antigen CA125 levels decreased between the two groups ( P < 0.05 , P < 0.01 ) .
RESULTS	Compared with the Mirena group , scores for dysmenorrhea integral increased and scores for SDBSS decreased in the CM treatment group ( P < 0.01 , P < 0.05 ) .
RESULTS	There was no statistical difference in the uterine volume or serum carbohydrate antigen CA125 levels ( P > 0.05 ) .
CONCLUSIONS	BHSD could effectively alleviate main symptoms of AM patients of QSBSS such as dysmenorrhea , profuse menstrual blood volume , and increased uterine volume , and lower scores for QSBSS and the total score for CM syndrome .

###24633684
BACKGROUND	Effective measures are needed to prevent methicillin-resistant Staphylococcus aureus ( MRSA ) skin and soft tissue infections ( SSTIs ) in high-risk community settings .
BACKGROUND	The study objective was to evaluate the effect of personal hygiene-based strategies on rates of overall SSTI and MRSA SSTI .
METHODS	We conducted a prospective , field-based , cluster-randomized trial in US Army Infantry trainees from May 2010 through January 2012 .
METHODS	There were 3 study groups with incrementally increased education and hygiene-based interventions : standard ( S ) , enhanced standard ( ES ) , and chlorhexidine ( CHG ) .
METHODS	The primary endpoints were incidence of overall SSTI and MRSA SSTI .
RESULTS	The study included 30 209 trainees constituting 540 platoons ( 168 S , 192 ES , and 180 CHG ) .
RESULTS	A total of 1203 ( 4 % ) participants developed SSTI , 316 ( 26 % ) due to MRSA .
RESULTS	The overall SSTI rate was 4.15 ( 95 % confidence interval [ CI ] , 3.77-4 .58 ) per 100 person-cycles .
RESULTS	SSTI rates by study group were 3.48 ( 95 % CI , 2.87-4 .22 ) for S , 4.18 ( 95 % CI , 3.56-4 .90 ) for ES , and 4.71 ( 95 % CI , 4.03-5 .50 ) for CHG .
RESULTS	The MRSA SSTI rate per 100 person-cycles for all groups was 1.10 ( 95 % CI , .91 -1.32 ) .
RESULTS	MRSA SSTI rates by study group were 1.0 ( 95 % CI , .70 -1.42 ) for S , 1.29 ( 95 % CI , .98 -1.71 ) for ES , and 0.97 ( 95 % CI , .70 -1.36 ) for CHG .
CONCLUSIONS	Personal hygiene and education measures , including once-weekly use of chlorhexidine body wash , did not prevent overall SSTI or MRSA SSTI in a high-risk population of military trainees .
BACKGROUND	NCT01105767 .

###25433006
OBJECTIVE	The growing incidence of infections caused by Enterobacteriaceae producing ESBLs has led to increased use of carbapenems .
OBJECTIVE	Temocillin , which resists most - lactamases , may be a useful alternative .
OBJECTIVE	The aim of this study was to assess the pharmacokinetics and target attainment rates of 6 g of temocillin daily divided into three administrations every 8 h ( three times daily ) or administered by continuous infusion in critically ill patients .
METHODS	This was a prospective , two-centre , randomized , controlled study in patients with intra-abdominal or lower respiratory tract infections caused by Enterobacteriaceae .
RESULTS	Thirty-two patients were included and analysed for clinical efficacy , and pharmacokinetics were measured in 29 of them .
RESULTS	Four patients undergoing continuous veno-venous haemofiltration ( CVVH ) were analysed separately .
RESULTS	Mean , median and range of percentages of the dosing interval during which the free drug concentration remained > 16 mg/L were 76.4 , 98 and 18.7-98 .9 in patients treated three times daily and 98.9 , 89.7 and 36.4-99 .9 in patients with continuous infusion , respectively .
RESULTS	Clinical cure rates were 79 % and 93 % in each of these groups , respectively ( not significant ) .
RESULTS	Patients with CVVH received a daily dose of 750 mg given by continuous infusion and had a mean free drug concentration of only 13.81.9 mg/L .
RESULTS	No adverse event attributable to temocillin was observed .
CONCLUSIONS	Temocillin ( 6 g daily ) given by continuous infusion allows a larger proportion of critically ill patients to have free drug serum concentrations covering infections caused by Enterobacteriaceae with an MIC of 16 mg/L compared with administration three times daily .
CONCLUSIONS	Clinical efficacy compared with carbapenems in documented severe infections needs to be further studied .

###24954487
OBJECTIVE	Tourniquet application is still a common practice in total knee arthroplasty ( TKA ) surgery despite being associated with several adverse effects .
OBJECTIVE	We evaluated the effects of tourniquet use on functional and clinical outcome and on knee range of motion ( ROM ) .
METHODS	70 patients who underwent TKA were randomized into a tourniquet group ( n = 35 ) and a non-tourniquet group ( n = 35 ) .
METHODS	All operations were performed by the same surgeon and follow-up was for 1 year .
METHODS	Primary outcomes were functional and clinical outcomes , as evaluated by KOOS and knee ROM .
METHODS	Secondary outcomes were intraoperative blood loss , surgical time and visibility , postoperative pain , analgesic consumption , and transfusion requirements .
RESULTS	Patients in the non-tourniquet group showed a better outcome in all KOOS subscores and better early knee ROM from surgery to week 8 .
RESULTS	No difference was detected at the 6 - and 12-month follow-ups .
RESULTS	Postoperative pain and analgesic consumption were less when a tourniquet was not used .
RESULTS	Surgical time and visibility were similar between groups .
RESULTS	Intraoperative blood loss was greater when not using a tourniquet , but no postoperative transfusions were required .
CONCLUSIONS	This study shows that TKA without the use of a tourniquet results in faster recovery in terms of better functional outcome and improved knee ROM .
CONCLUSIONS	Furthermore , reduced pain and analgesic use were registered and no intraoperative difficulties were encountered .

###24923300
BACKGROUND	Countries in sub-Saharan Africa ( SSA ) are experiencing an epidemic of cardiovascular disease ( CVD ) propelled by rapidly increasing rates of hypertension .
BACKGROUND	Barriers to hypertension control in SSA include poor access to care and high out-of-pocket costs .
BACKGROUND	Although SSA bears 24 % of the global disease burden , it has only 3 % of the global health workforce .
BACKGROUND	Given such limited resources , cost-effective strategies , such as task shifting , are needed to mitigate the rising CVD epidemic in SSA .
BACKGROUND	Ghana , a country in SSA with an established community health worker program integrated within a national health insurance scheme provides an ideal platform to evaluate implementation of the World Health Organization ( WHO ) task-shifting strategy .
BACKGROUND	This study will evaluate the comparative effectiveness of the implementation of the WHO Package targeted at CV risk assessment versus provision of health insurance coverage , on blood pressure ( BP ) reduction .
METHODS	Using a cluster randomized design , 32 community health centers ( CHCs ) and district hospitals in Ghana will be randomized to either the intervention group ( 16 CHCs ) or the control group ( 16 CHCs ) .
METHODS	A total of 640 patients with uncomplicated hypertension ( BP 140-179/90 -99 mm Hg and absence of target organ damage ) will be enrolled in this study ( 20 patients per CHC ) .
METHODS	The intervention consists of WHO Package of CV risk assessment , patient education , initiation and titration of antihypertensive medications , behavioral counseling on lifestyle behaviors , and medication adherence every three months for 12 months .
METHODS	The primary outcome is the mean change in systolic BP from baseline to 12 months .
METHODS	The secondary outcomes are rates of BP control at 12 months ; levels of physical activity , percent change in weight , and dietary intake of fruits and vegetables at 12 months ; and sustainability of intervention effects at 24 months .
METHODS	All outcomes will be assessed at baseline , six months and 12 months .
METHODS	Trained community health nurses will deliver the intervention as part of Ghana 's community-based health planning and services ( CHPS ) program .
CONCLUSIONS	Findings from this study will provide policy makers and other stakeholders needed information to recommend scalable and cost-effective policy with respect to comprehensive CV risk reduction and hypertension control in resource-poor settings .
BACKGROUND	NCT01802372 .

###24825416
BACKGROUND	Because insulin dosing requires optimization of glycemic control , it is important to use a single metric of benefit and risk to determine best insulin dosing practices .
BACKGROUND	We retrospectively applied a multiplicative clinical utility index ( CUI ) to a study of LY2605541 ( Eli Lilly and Company , Indianapolis , IN ) , a novel , long-acting basal insulin .
METHODS	A CUI was developed to transform the multidimensional problem of assessing benefit/risk of multiple dosing algorithms into a single decision-making metric to evaluate two LY2605541 dosing algorithms relative to the insulin glargine ( GL ) dosing algorithm .
METHODS	The CUI was applied to data in a 12-week , open-label , Phase 2 trial in patients with type 2 diabetes mellitus who were randomized to one of two dosing algorithms for LY2605541 ( LY1 or LY2 ) or GL ( algorithm similar to LY1 ) .
METHODS	The CUI was created ( via expert input ) by weighing the relative benefit/risk of four components ( glycosylated hemoglobin [ HbA1c ] , percentage of patients with HbA1c 7 % , hypoglycemia rate , and time to steady-state dose ) ; individual utility values were multiplied to compute CUI values for LY1 and LY2 relative to GL , and bootstrap samples were used to determine variability .
RESULTS	The mean CUI was 0.82 for LY1 and 1.35 for LY2 .
RESULTS	Based on 3,000 bootstrap samples , there was a 48 % probability of LY2 performing better than LY1 and a 28 % probability of LY1 performing better than LY2 .
CONCLUSIONS	CUI methodology , and in particular this CUI , is a useful tool for comparing dosing algorithms .
CONCLUSIONS	Based on this CUI , LY2 is likely to be a better dosing algorithm than LY1 .

###25577145
BACKGROUND	Patients undergoing open heart surgery with cardiopulmonary bypass ( CPB ) often develop a systemic immune reaction , characterized by an increase of proinflammatory and anti-inflammatory mediators .
BACKGROUND	We previously demonstrated that continued mechanical ventilation during CPB reduces this response .
BACKGROUND	We hypothesized that this strategy may also impact on matrix metalloproteinase ( MMP ) release .
METHODS	Thirty consecutive patients undergoing coronary artery bypass grafting with CPB were randomized into a ventilated ( VG ) ( n = 15 ) and a standard non-ventilated group ( NVG ) ( n = 15 ) .
METHODS	Blood was collected at the beginning , at the end of surgery , and on the five consecutive days .
METHODS	MMPs , tissue inhibitor of matrix metalloproteinase 1 ( TIMP-1 ) , and lipocalin 2 ( LCN2 ) were measured by enzyme-linked immunosorbent assay .
METHODS	Parameters of transpulmonary oxygen transport were assessed at different time points .
RESULTS	MMP-8 , MMP-9 , and LCN2 were significantly lower at the end of surgery in VG compared with those in NVG patients ( MMP-8 [ ng/mL ] : 7.1 [ 3.5 ] versus 12.5 [ 7.7 ] , P = 0.02 ; MMP-9 [ ng/mL ] : 108 [ 42 ] versus 171 [ 98 ] , P = 0.029 ; LCN2 [ ng/mL ] : 109 [ 42 ] versus 171 [ 98 ] , P = 0.03 ) .
RESULTS	TIMP-1 concentrations were lower on postoperative day one , ( TIMP-1 [ ng/mL ] : 174 [ 55 ] versus 273 [ 104 ] , P = 0.003 ) , whereas MMP-3 levels were lower on postoperative days four and five ( MMP-3 [ ng/mL ] : 44 [ 17 ] versus 67 [ 35 ] , P = 0.026 ) .
RESULTS	The arterial partial pressure of oxygen/fraction of inspired oxygen ratio was significantly higher in VG patients throughout the postoperative observation period , which did not affect the length of postoperative ventilatory support .
CONCLUSIONS	Continued mechanical ventilation during CPB reduces serum levels of MMPs , their inhibitor TIMP-1 and LCN2 , which preserves MMP-9 activity .
CONCLUSIONS	The present study suggests that continued mechanical ventilation improves postoperative oxygenation and could potentially prevent aggravation of lung injury after CPB .

###24925090
OBJECTIVE	Opicapone is a novel third generation catechol-O-methyltransferase ( COMT ) inhibitor .
OBJECTIVE	The purpose of this study was to compare the levodopa pharmacokinetic profile throughout a day driven by the COMT inhibition either following repeated doses of opicapone or concomitant administration with entacapone .
METHODS	A randomized , double-blind , gender-balanced , parallel-group study was performed in 4 groups of 20 healthy subjects each .
METHODS	Four subjects in each group received placebo during the entire study .
METHODS	Sixteen subjects in one group received placebo once daily for 11 days and on day 12 , 200 mg entacapone concomitantly with each levodopa/carbidopa dose ( three times separated by a 5-h interval ) .
METHODS	Sixteen subjects in each of the remaining three groups received respectively 25 , 50 , and 75 mg opicapone once daily for 11 days and on day 12 , placebo concomitantly with each levodopa/carbidopa dose .
RESULTS	Levodopa minimum plasma concentration ( Cmin ) for each levodopa/carbidopa dose and for the mean of all levodopa/carbidopa doses increased substantially with all active treatments ( entacapone and opicapone ) when compared to the control group ( placebo ) , with values ranging from 1.7-fold ( 200 mg entacapone ) to 3.3-fold ( 75 mg opicapone ) .
RESULTS	No statistical difference was found for levodopa peak of systemic exposure ( as assessed by maximum observed plasma concentration ( Cmax ) ) between all active treatments and placebo .
RESULTS	A significant increase in the levodopa extent of systemic exposure ( as assessed by concentration-time curve ( AUC ) ) occurred with all opicapone treatments in relation to placebo .
RESULTS	No statistical difference was found for levodopa AUC when entacapone was compared to placebo .
RESULTS	When compared to entacapone , both 50 and 75 mg opicapone presented a significant increase for the levodopa AUC .
RESULTS	All active treatments significantly inhibited both peak ( as assessed by Emax ) and extent ( as assessed by effect-time curve ( AUEC ) ) of the COMT activity in relation to placebo .
RESULTS	When compared to entacapone , all opicapone treatments significantly decreased the extent ( AUEC ) of the COMT activity due to a long-lasting and sustained effect .
RESULTS	The tolerability profile was favorable for all active treatments .
CONCLUSIONS	Opicapone , a novel third generation COMT inhibitor , when compared to entacapone , provides a superior response upon the bioavailability of levodopa associated to more pronounced , long-lasting , and sustained COMT inhibition .
CONCLUSIONS	The tolerability profile was favorable .
CONCLUSIONS	On the basis of the results presented in this study and along with the earlier pharmacology studies , it is anticipated that opicapone adjunct therapy at the dosages of 25 and 50 mg will provide an enhancement in levodopa availability that will translate into clinical benefit for Parkinson 's disease patients .

###24231625
OBJECTIVE	To analyze the acute physiological response to aerobic short-interval training ( AESIT ) at various high-intensity running speeds .
OBJECTIVE	A minor anaerobic glycolytic energy supply was aimed to mimic the characteristics of slow continuous runs .
METHODS	Eight trained male runners ( maximal oxygen uptake [ VO ( 2max ) ] 55.5 3.3 mL kg ( -1 ) min ( -1 ) ) performed an incremental treadmill exercise test ( increments : 0.75 km h ( -1 ) min ( -1 ) ) .
METHODS	Two lactate turn points ( LTP1 , LTP2 ) were determined .
METHODS	Subsequently , 3 randomly assigned AESIT sessions with high-intensity running-speed intervals were performed at speeds close to the speed ( v ) at VO ( 2max ) ( vVO ( 2max ) ) to create mean intensities of 50 % , 55 % , and 60 % of vLTP1 .
METHODS	AESIT sessions lasted 30 min and consisted of 10-s work phases , alternated by 20-s passive recovery phases .
RESULTS	To produce mean velocities of 50 % , 55 % , and 60 % of vLTP1 , running speeds were calculated as 18.6 0.7 km/h ( 93.4 % vVO ( 2max ) ) , 20.2 0.6 km/h ( 101.9 % vVO ( 2max ) ) , and 22.3 0.7 km/h ( 111.0 % vVO ( 2max ) ) , which gave a mean blood lactate concentration ( La ) of 1.09 0.31 mmol/L , 1.57 0.52 mmol/L , and 2.09 0.99 mmol/L , respectively .
RESULTS	La at 50 % of vLTP1 was not significantly different from La at vLTP1 ( P = .8894 ) .
RESULTS	Mean VO ( 2 ) was found at 54.0 % , 58.5 % , and 64.0 % of VO ( 2max ) , while at the end of the sessions VO ( 2 ) rose to 71.1 % , 80.4 % , and 85.6 % of VO ( 2max ) , respectively .
CONCLUSIONS	The results showed that AESIT with 10-s work phases alternating with 20 s of passive rest and a running speed close to vVO ( 2max ) gave a systemic aerobic metabolic profile similar to slow continuous runs .

###24764070
BACKGROUND	Cluster analysis can be used to identify individuals similar in profile based on response to multiple pain sensitivity measures .
BACKGROUND	There are limited investigations into how empirically derived pain sensitivity subgroups influence clinical outcomes for individuals with spine pain .
OBJECTIVE	The purposes of this study were : ( 1 ) to investigate empirically derived subgroups based on pressure and thermal pain sensitivity in individuals with spine pain and ( 2 ) to examine subgroup influence on 2-week clinical pain intensity and disability outcomes .
METHODS	A secondary analysis of data from 2 randomized trials was conducted .
METHODS	Baseline and 2-week outcome data from 157 participants with low back pain ( n = 110 ) and neck pain ( n = 47 ) were examined .
METHODS	Participants completed demographic , psychological , and clinical information and were assessed using pain sensitivity protocols , including pressure ( suprathreshold pressure pain ) and thermal pain sensitivity ( thermal heat threshold and tolerance , suprathreshold heat pain , temporal summation ) .
METHODS	A hierarchical agglomerative cluster analysis was used to create subgroups based on pain sensitivity responses .
METHODS	Differences in data for baseline variables , clinical pain intensity , and disability were examined .
RESULTS	Three pain sensitivity cluster groups were derived : low pain sensitivity , high thermal static sensitivity , and high pressure and thermal dynamic sensitivity .
RESULTS	There were differences in the proportion of individuals meeting a 30 % change in pain intensity , where fewer individuals within the high pressure and thermal dynamic sensitivity group ( adjusted odds ratio = 0.3 ; 95 % confidence interval = 0.1 , 0.8 ) achieved successful outcomes .
CONCLUSIONS	Only 2-week outcomes are reported .
CONCLUSIONS	Distinct pain sensitivity cluster groups for individuals with spine pain were identified , with the high pressure and thermal dynamic sensitivity group showing worse clinical outcome for pain intensity .
CONCLUSIONS	Future studies should aim to confirm these findings .

###24512193
OBJECTIVE	To evaluate attainment of diabetes-related quality measures with canagliflozin , a sodium glucose cotransporter 2 inhibitor , versus sitagliptin in patients with type 2 diabetes mellitus ( T2DM ) .
METHODS	This post hoc analysis included data from a 52-week , randomized , double-blind , phase 3 study comparing canagliflozin 300 mg and sitagliptin 100 mg in patients with T2DM on metformin plus sulfonylurea .
METHODS	Individual and composite diabetes-related quality measures based on glycated hemoglobin ( A1C ) , blood pressure ( BP ) , low-density lipoprotein cholesterol ( LDL-C ) level , body mass index ( BMI ) , and body weight were assessed in the overall population and a subgroup with a baseline BMI of at least 25 kg/m .
RESULTS	At baseline , the proportion of patients meeting criteria for quality measures was similar between groups .
RESULTS	At week 52 , more canagliflozin-treated patients achieved quality measures of an A1C less than 8 % or less than 7 % , and fewer canagliflozintreated patients had an A1C greater than 9 % , compared with sitagliptin .
RESULTS	More patients achieved BP measurement less than 140/90 mm Hg , less than 140/80 mm Hg , or less than 130/80 mm Hg with canagliflozin versus sitagliptin .
RESULTS	The proportion of patients with an LDL-C level less than 100 mg/dL was similar between groups .
RESULTS	More patients had a BMI of at least 25 kg/m and a greater than 10 lb ( 4.5 kg ) weight loss from baseline , and a BMI less than 30 kg/m at week 52 , with canagliflozin versus sitagliptin .
RESULTS	A greater proportion of patients achieved composite end points based on A1C , BP , and LDL-C level with canagliflozin versus sitagliptin .
RESULTS	Similar results were observed in the subgroup of patients with a baseline BMI of at least 25 kg/m .
CONCLUSIONS	In this study involving patients with T2DM on metformin plus sulfonylurea , after 52 weeks , patients treated with canagliflozin 300 mg demonstrated better attainment of individual and composite diabetes-related quality measures compared with patients treated with sitagliptin 100 mg .

###24464258
OBJECTIVE	The purpose of this study was to determine the safety and efficacy of adjuvant albendazole medication in percutaneous liver hydatid cyst treatment with puncture , aspiration , injection , and reaspiration ( PAIR ) method .
METHODS	Between November 2007 and May 2011 , total of 39 patients with newly diagnosed liver hydatid cyst ( total of 77 cysts ) were prospectively randomized and enrolled in 3 groups .
METHODS	In the first group , cysts ( n = 14 ) were treated with PAIR without albendazole .
METHODS	In the second ( n = 16 ) and third groups ( n = 47 ) , cysts were treated with PAIR with albendazole 1 week before and 1 month after the procedure , with albendazole 1 week before and 3 months after the procedure respectively .
RESULTS	Technical and clinical success rates were 100 and 96.1 % respectively .
RESULTS	In 3 of 77 cysts ( 3.9 % ) , findings of recurrence were detected on US imaging .
RESULTS	All recurrent cysts were in group 1 and recurrence rates in this group were statistically different from cysts of second and third groups ( p = 0.005 ) .
RESULTS	Side effects of albendazole were detected in 7 of 29 patients ( 24.1 % ) , and no statistically significant difference was observed between the second ( 15.3 % ) and third ( 38.4 % ) groups ( p = 0.378 ) .
CONCLUSIONS	Use of albendazole medication as an adjuvant to percutaneous treatment of liver hydatid cyst decreases the recurrence rate .
CONCLUSIONS	Although there is no statistically significant difference between groups 2 and 3 in terms of efficacy and recurrence rate , patients in group 3 had a higher rate of side effect .
CONCLUSIONS	Therefore , we conclude that albendazole treatment 1 week before and 1 month after PAIR treatment is sufficient to reduce/prevent recurrences .

###24942592
OBJECTIVE	Liver cirrhosis is one of the major consequences of hepatitis B virus ( HBV ) infection , and transplantation of autologous bone marrow mesenchymal stem cells ( ABMSCs ) is one of promising therapies for patients with HBV-related liver cirrhosis ( HBV-LC ) .
OBJECTIVE	However , the mechanism is unclear .
OBJECTIVE	The aim of the current study was to explore the role of Treg/Th17 cells in ABMSCs transplantation in patients with HBV-LC .
METHODS	In this prospective study , 56 patients were enrolled and randomly assigned to transplantation group and control group .
METHODS	After 24-week follow-up , 39 patients completed the study ( 20 cases in transplantation group and 19 cases in control group ) .
METHODS	The Model for End-Stage Liver Disease scores , liver function , changes of Treg/Th17 cells , as well as related transcription factors and serum cytokines , were determined .
RESULTS	Although patients in both groups showed significant improvement after Entecavir treatment , ABMSC transplantation further improved patients ' liver function .
RESULTS	Moreover , there was a significant increase in Treg cells and a marked decrease in Th17 cells in the transplantation group compared with control , leading to an increased Treg/Th17 ratio .
RESULTS	Furthermore , mRNA levels of Treg-related transcription factor ( Foxp3 ) and Th17-related transcription factor ( RORt ) were increased and decreased , respectively .
RESULTS	In addition , serum transforming growth factor - levels were significantly higher at early weeks of transplantation , while serum levels of interleukin-17 , tumor necrosis factor - , and interleukin-6 were significantly lower in patients in the transplantation group compared with control .
CONCLUSIONS	ABMSCs transplantation was effective in improving liver function in patients with HBV-LC , which was mediated , at least in part , through the regulation of Treg/Th17 cell balance .

###24988965
OBJECTIVE	To study the effect of melatonin ( melaxen ) on sleep disorders in patients with mild cranial-brain injury ( CBI ) in the early rehabilitation period .
METHODS	Sixty patients were randomized to equal groups treated or not treated with melaxen .
METHODS	Along with neurological and somatic examination , polysomnography and scales for measurement depression and quality of life ( ESS , BDI , EuroQol etc ) were used .
CONCLUSIONS	Melatonin improved sleep ( sleep latency , number of wakings per night etc ) and decreased the severity of depression in the early rehabilitation period after mild CBI .
CONCLUSIONS	Further research is needed to fully understand the effect of melatonin on sleep disorders in CBI , in particular in its later stages .

###24656872
OBJECTIVE	To evaluate factors associated with low consumption of fruits and vegetables among preschoolers from families treated at basic health centers in Porto Alegre , RS , Brazil .
METHODS	This was a cohort study nested in a randomized field trial .
METHODS	Data collection was performed through structured questionnaires to obtain demographic and dietary data , combined with two 24-hour recalls in the age groups 12-16 months and again at 2-3 years of age .
METHODS	Data on the consumption of one daily serving of fruits ( 80 g ) and vegetables ( 60 g ) were evaluated , as well as consumption of non-recommended foods such as candy , chocolate , and soft drinks .
METHODS	Statistical analyses were performed using Poisson regression with robust estimation .
RESULTS	A total of 388 children aged 2-3 years were evaluated ; of these , 58 % and 87.4 % did not consume one daily serving of fruits and vegetables , respectively .
RESULTS	The following factors were negatively associated with fruit consumption : family income higher than four minimum wages , ( p = 0.024 ) , lower paternal educational level ( p = 0.03 ) , and lower fruit consumption at 12-16 months ( p = 0.002 ) .
RESULTS	Factors negatively associated with the consumption of vegetables were low paternal educational level ( p = 0.033 ) and consumption of high-sugar content beverages at 12-16 months ( p = 0.014 ) .
CONCLUSIONS	This study demonstrated a high prevalence of children who consumed less than one daily serving of fruit and vegetables ; early feeding practices , parental education , and family income were associated with this process .

###25363174
BACKGROUND	Pilonidal sinus is a common infectious process which occurs in buttocks and sacral area which involves a wide range of symptoms that are different from an asymptomatic sinus abscess to acute and chronic sinus track .
BACKGROUND	Basically non-surgical treatment for this disease is not recommended .
BACKGROUND	In this study , we have been compared two methods of primary repair and rotation flap in terms of factors such as duration of hospitalization , recurrence , infection etc. .
METHODS	80 patients with chronic pilonidal sinus were randomly divided into two groups and underwent surgery .
METHODS	Diabetic and obese patients with underlying diseases and patients with acute pilonidal abscess or prior surgery were excluded .
METHODS	The patients ' hospital stay , duration of postoperative pain , itching and hematoma , were investigated .
RESULTS	In this study , patients ' sex and mean age were examined in terms of frequency of complications of hematoma , wound infection , recurrence , itching , and duration of hospitalization and the presence of seroma , there is no significant difference between the two methods of primary surgical repair and rotation flap ( P > 0.05 ) But in terms of the opening of the surgical wound , in primary surgical method , 5 patients ( 12.5 % ) , wound dehiscence were reported , in rotation flap , any case of wound dehiscence were reported .
RESULTS	There is significant difference between wound dehiscence in patients with chronic pilonidal sinus and two methods of surgery .
RESULTS	( P = 0.02 ) .
RESULTS	The mean duration of pain relief was 15.2 3.35 days in the primary surgical repair method and rotation flap was 7 2.3 days .
RESULTS	According to the test there is significant difference between mean duration of pain relief and two surgical methods .
RESULTS	( P = 0.001 ) .
RESULTS	The mean duration of sutures was 15.3 2.3 days in the primary repair method and in rotational flap was 12 3.6 days .
RESULTS	There is significant difference between the mean duration of sutures and two surgical methods ( P = 0.001 ) CONCLUSION : Considering these results , rotational flap is the preferred method due to fewer complications , lower recurrence after surgery and faster healing time of surgical wounds and as a result , the effective force 's early return to economic cycle .
RESULTS	Finally , we can say that each surgeon according to the type and size of the sinuses and occupational status and social class , personality and individuality of the patient can select the appropriate method of surgery .

###24937025
OBJECTIVE	This study aims to prospectively assess the incidence of hypercalciuria and hypercalcemia with different doses of vitamin D and with a calcium intake of approximately 1,200 mg/day .
METHODS	This was a 1-year randomized placebo-controlled study of vitamin D ( 400-4 ,800 IU/d ) in 163 white women aged 57 to 90 years .
METHODS	Calcium citrate tablets ( 200 mg ) were added to the diet to achieve a total calcium intake of approximately 1,200 mg/day in all groups .
METHODS	All women had vitamin D insufficiency at baseline , with serum 25-hydroxyvitaminD levels lower than 20 ng/mL ( 50 nmol/L ) .
METHODS	Serum and 24-hour urine calcium were collected every 3 months on supplementation , any test result above the upper reference range represented an episode of hypercalcemia or hypercalciuria .
METHODS	Mixed-effects models and multivariate logistic regression were used in the analysis .
RESULTS	Hypercalcemia ( > 10.2 mg/dL [ 2.55 mmol/L ] ) occurred in 8.8 % of white women .
RESULTS	Hypercalciuria ( > 300 mg/d [ 7.5 mmol ] ) occurred in 30.6 % of white women .
RESULTS	Episodes of hypercalciuria were transient in half of the group and recurrent in the other half .
RESULTS	No relationship between hypercalcemia or hypercalciuria and vitamin D dose was found , and hypercalciuria was equally common in the placebo group .
CONCLUSIONS	Hypercalciuria and hypercalcemia commonly occur with vitamin D and calcium supplements .
CONCLUSIONS	Whether hypercalciuria and hypercalcemia are caused by calcium , vitamin D , or both is unclear .
CONCLUSIONS	These findings may have relevance to the reported increase in kidney stones in the Women 's Health Initiative trial .
CONCLUSIONS	Because calcium 1,200 mg and vitamin D 800 IU/day are widely recommended in postmenopausal women , systematic evaluation of the safety of supplements is warranted in clinical management and in future studies .

###24823906
OBJECTIVE	A universal Internet-based preventive intervention has been shown to reduce alcohol and cannabis use .
OBJECTIVE	The aim of this study was to examine if this program could also reduce risk-factors associated with substance use in adolescents .
METHODS	A cluster randomised controlled trial was conducted in Sydney , Australia in 2007-2008 to assess the effectiveness of the Internet-based Climate Schools : Alcohol and Cannabis course .
METHODS	The evidence-based course , aimed at reducing alcohol and cannabis use , consists of two sets of six lessons delivered approximately six months apart .
METHODS	A total of 764 students ( mean 13.1 years ) from 10 secondary schools were randomly allocated to receive the preventive intervention ( n = 397 , five schools ) , or their usual health classes ( n = 367 , five schools ) over the year .
METHODS	Participants were assessed at baseline , immediately post , and six and twelve months following the intervention on their levels of truancy , psychological distress and moral disengagement .
RESULTS	Compared to the control group , students in the intervention group showed significant reductions in truancy , psychological distress and moral disengagement up to twelve months following completion of the intervention .
CONCLUSIONS	These intervention effects indicate that Internet-based preventive interventions designed to prevent alcohol and cannabis use can concurrently reduce risk-factors associated with substance use in adolescents .
BACKGROUND	Australian Clinical Trials Registry ACTRN : 012607000312448 .

###24664093
OBJECTIVE	To assess the efficacy of collaborative care for behavior problems , attention-deficit/hyperactivity disorder ( ADHD ) , and anxiety in pediatric primary care ( Doctor Office Collaborative Care ; DOCC ) .
METHODS	Children and their caregivers participated from 8 pediatric practices that were cluster randomized to DOCC ( n = 160 ) or enhanced usual care ( EUC ; n = 161 ) .
METHODS	In DOCC , a care manager delivered a personalized , evidence-based intervention .
METHODS	EUC patients received psychoeducation and a facilitated specialty care referral .
METHODS	Care processes measures were collected after the 6-month intervention period .
METHODS	Family outcome measures included the Vanderbilt ADHD Diagnostic Parent Rating Scale , Parenting Stress Index-Short Form , Individualized Goal Attainment Ratings , and Clinical Global Impression-Improvement Scale .
METHODS	Most measures were collected at baseline , and 6 - , 12 - , and 18-month assessments .
METHODS	Provider outcome measures examined perceived treatment change , efficacy , and obstacles , and practice climate .
RESULTS	DOCC ( versus EUC ) was associated with higher rates of treatment initiation ( 99.4 % vs 54.2 % ; P < .001 ) and completion ( 76.6 % vs 11.6 % , P < .001 ) , improvement in behavior problems , hyperactivity , and internalizing problems ( P < .05 to .01 ) , and parental stress ( P < .05 -.001 ) , remission in behavior and internalizing problems ( P < .01 , .05 ) , goal improvement ( P < .05 to .001 ) , treatment response ( P < .05 ) , and consumer satisfaction ( P < .05 ) .
RESULTS	DOCC pediatricians reported greater perceived practice change , efficacy , and skill use to treat ADHD ( P < .05 to .01 ) .
CONCLUSIONS	Implementing a collaborative care intervention for behavior problems in community pediatric practices is feasible and broadly effective , supporting the utility of integrated behavioral health care services .

###25479804
BACKGROUND	Self-collected human papillomavirus ( HPV ) testing could reduce barriers to cervical cancer screening , with performance comparable to clinician-collected specimens .
BACKGROUND	The ability of self-collected specimens to cross-sectionally and prospectively detect precursor lesions was investigated in an HPV vaccine randomized trial in Costa Rica .
METHODS	In the trial , 7466 women age 18 to 25 years received an HPV16/18 or control vaccine and were followed at least annually for four years .
METHODS	In this secondary analysis , we included all women who provided a self-collected cervicovaginal specimen six months after enrollment ( 5109 women = full analytical cohort ) .
METHODS	A subset ( 615 women = restricted cohort ) also had clinician-collected specimens at the six-month postenrollment visit .
METHODS	High-grade squamous intraepithelial lesion or repeat low-grade squamous intraepithelial lesion prompted colposcopic referral throughout the study .
METHODS	HPV testing was performed with SPF10PCR/DEIA/LiPA25 .
METHODS	Cross-sectional and prospective sensitivity , specificity , and predictive values were estimated .
RESULTS	In the full cohort , one-time HPV testing on self-collected samples detected prevalent CIN2 + with a sensitivity of 88.7 % ( 95 % confidence interval [ CI ] = 77.0 % to 95.7 % ) and a specificity of 68.9 % ( 95 % CI = 67.6 % to 70.1 % ) .
RESULTS	For predicting incident CIN2 + in the subsequent four years , sensitivity was 73.9 % ( 95 % CI = 65.8 % to 81.0 % ) and specificity 69.4 % ( 95 % CI = 68.1 % to 70.7 % ) .
RESULTS	In the restricted cohort , for incident CIN2 + , self-collected HPV was much more sensitive than cytology ( 80.0 % vs 10.0 % ) ; relative sensitivity was 0.1 ( 95 % CI = 0.03 % to 0.5 % ) .
RESULTS	Furthermore , three times more women with normal baseline cytology developed incident CIN2 + than those with negative self-collected HPV .
RESULTS	Self-collected and clinician-collected HPV testing had comparable performance .
RESULTS	Agreement between self - and clinician-collected samples was 89.7 % ( kappa = 0.78 , McNemar 2 = 0.62 ) for carcinogenic HPV types .
CONCLUSIONS	Self-collected specimens can be used for HPV-based screening , providing sensitivity and specificity comparable with clinician-collected specimens and detecting disease earlier than cytology .

###25720600
OBJECTIVE	To investigate the effect of parenteral insulin therapy on endogenous insulin secretion in the Diabetes Prevention Trial-Type 1 ( DPT-1 ) .
METHODS	In the parenteral insulin arm of DPT-1 , subjects without diabetes at high risk of future type 1 diabetes randomized to active treatment received a yearly 4-day intravenous insulin infusion ( IV-I ) and daily subcutaneous insulin ( SC-I ) .
METHODS	To examine the effects of these insulin therapies on endogenous insulin secretion , C-peptide and glucose levels were compared during oral glucose tolerance tests ( OGTTs ) performed on and off IV-I and SC-I .
METHODS	Forty-six paired OGTTs were performed in 30 subjects from DPT-1 to determine the effect of IV-I .
METHODS	Twenty paired OGTTs were performed in 15 subjects from DPT-1 to determine the effect of SC-I .
RESULTS	IV-I suppressed fasting and OGTT-stimulated C-peptide ( 62 % and 40 % , respectively ) , and it significantly lowered fasting glucose ( 67.4 4.5 mg/dL during IV-I vs. 90.9 1.8 mg/dL off insulin ; P < 0.05 ) .
RESULTS	By contrast , post-OGTT glucose levels were significantly higher during IV-I : Glucose during IV-I versus off insulin at 120 min was 203.9 15.1 vs. 151.6 10.2 mg/dL , respectively ( P < 0.05 ) ; 49 % of OGTTs became transiently diabetic ( > 200 mg/dL at 120 min ) when receiving IV-I .
RESULTS	Fasting glucose was significantly lower when receiving SC-I versus when off insulin ( 85 3 vs. 94 2 mg/dL , respectively ; P < 0.05 ) , but SC-I did not significantly alter fasting or OGTT-stimulated C-peptide compared with being off insulin .
CONCLUSIONS	These data demonstrate that the IV-I used in the DPT-1 markedly suppressed endogenous insulin secretion , which was frequently associated with postprandial glucose intolerance .
CONCLUSIONS	SC-I , however , did not .

###25116230
BACKGROUND	Some of the health advantages of breast-fed as compared to formula-fed infants have been suggested to be due to metabolic programming effects resulting from early nutrition .
METHODS	In a prospective double-blinded randomized trial , 160 infants < 2 mo of age were randomized to experimental formula ( EF ) with added milk fat globule membrane ( MFGM ) or standard formula ( SF ) until 6 mo of age .
METHODS	A breast-fed reference ( BFR ) group consisted of 80 infants .
METHODS	Measurements were made at inclusion and at 4 , 6 , and 12 mo of age .
RESULTS	During the intervention , the EF group had higher total serum cholesterol concentration than the SF group , reaching the level of the BFR group .
RESULTS	The EF group had a low-density lipoprotein to high-density lipoprotein ratio not significantly different from the SF group but lower than the BFR group .
CONCLUSIONS	Supplementation of infant formula with MFGM modified the fat composition of the formula and narrowed the gap between breast-fed and formula-fed infants with regard to serum lipid status at 12 mo. .

###25251888
OBJECTIVE	Chronic obstructive pulmonary disease ( COPD ) is associated with increased morbidity and mortality and reduced quality of life ( QoL ) .
OBJECTIVE	Novel interventions are needed to improve outcomes in COPD patients .
OBJECTIVE	The present study assessed the effects of a telephone-based coping skills intervention on psychological and somatic QoL and on the combined medical end point of COPD-related hospitalizations and all-cause mortality .
METHODS	We conducted a dual-site , randomized clinical trial with assessments at baseline and after 16 weeks of treatment .
METHODS	The study population comprised 326 outpatients with COPD aged 38 to 81 years , randomized to coping skills training ( CST ) or to COPD education ( COPD-ED ) .
METHODS	Patients completed a battery of QoL instruments , pulmonary function tests , and functional measures and were followed up for up to 4.4 years to assess medical outcomes .
RESULTS	The CST group exhibited greater improvements in psychological QoL compared with controls ( p = .001 ) , including less depression ( Cohen d = 0.22 [ 95 % confidence interval , or CI = 0.08-0 .36 ] ) and anxiety ( d = 0.17 [ 95 % CI = 0.02-0 .33 ] ) , and better overall mental health ( d = 0.17 [ 95 % CI = 0.03-0 .32 ] ) , emotional role functioning ( d = 0.29 [ 95 % CI = 0.10-0 .48 ] ) , vitality ( d = 0.27 [ 95 % CI = 0.11 , 0.42 ] ) , and social functioning ( d = 0.21 [ 95 % CI = 0.03-0 .38 ] ) .
RESULTS	A significant baseline psychological QoL by treatment group interaction revealed that CST with lower QoL at baseline achieved even greater improvements in psychological QoL compared with COPD-ED .
RESULTS	CST participants also exhibited greater improvements in somatic QoL ( p = .042 ) , including greater improvements in pulmonary QoL ( d = 0.13 [ 95 % CI = 0.01-0 .24 ] ) , less fatigue ( d = 0.34 [ 95 % CI = 0.18-0 .50 ] ) , and less shortness of breath ( d = 0.11 [ 95 % CI = -0.01 to 0.23 ] ) and greater improvement in distance walked on the Six-Minute Walk test ( d = 0.09 [ 95 % CI = 0.01-0 .16 ] ) .
RESULTS	However , there was no significant difference in risk of time to COPD-related hospitalization or all-cause mortality between CST ( 34 events ) and COPD-ED ( 32 events ; p = 0.430 ) .
CONCLUSIONS	A telehealth CST intervention produced clinically meaningful improvements in QoL and functional capacity , but no overall improvement in risk of COPD-related hospitalization and all-cause mortality .
BACKGROUND	clinicaltrials.gov Identifier : NCT00736268 .

###25397788
OBJECTIVE	Comparison of visual acuity , refractive , and wavefront outcomes associated with optimized prolate ablation ( OPA ) and optical path difference custom aspheric treatment ( OPDCAT ) algorithms for correction of myopia exceeding 8 diopters ( D ) .
METHODS	Patients were randomly assigned to have photorefractive keratectomy ( PRK ) with OPA ( n = 32 ) or OPDCAT ( n = 21 ) algorithms .
METHODS	Visual acuity , manifest refraction , ocular and corneal higher-order aberrations , corneal asphericity , modulated-transfer function , and point-spread function were compared 1 , 3 , and 6 months postoperatively .
RESULTS	Mean manifest-refraction spherical equivalents at 6 months were -0.24 D in both groups .
RESULTS	All patients in both groups had an uncorrected-distance visual acuity of 20/20 or better .
RESULTS	Predictability ( 1D from intended refraction ) at 6 months was 94 % in the OPA group , and in the OPDCAT group it was 86 % .
RESULTS	The OPA group had less induced corneal and ocular spherical aberrations ( SAs ) than the OPDCAT group .
RESULTS	Postoperative corneal asphericity change was lowest in the OPA group .
RESULTS	Both the groups exhibited significantly-improved AreaRatio-Total value and insignificantly deteriorated AreaRatio-HO value throughout the postoperative period .
RESULTS	The OPA group had significantly-higher AreaRatio-Total compared with OPDCAT group at both 1 and 6 months after the operation .
RESULTS	Six months after surgery , the Strehl ratio had decreased in both groups , and there was no significant difference between the groups .
CONCLUSIONS	The OPA algorithms yielded higher-objective visual quality and predictability , induced less corneal and ocular SAs , and preserved more preoperative-corneal asphericity than the OPDCAT algorithms .

###25492272
OBJECTIVE	This study draws on baseline data from the At Home/Chez Soi demonstration project to examine the association between parenting status and mental health among homeless women and whether the association varies by duration of homelessness .
METHODS	Structured interviews were conducted with participants in five cities across Canada including Moncton , Montreal , Toronto , Vancouver and Winnipeg .
METHODS	Eligibility criteria included those with legal adult status , with a mental illness , and who lacked a regular , fixed shelter .
METHODS	All 713 women who participated in the larger project were selected for inclusion in this analysis .
METHODS	The mental health conditions of interest include depression , post-traumatic stress disorder ( PTSD ) , alcohol dependence and substance dependence .
RESULTS	The relationship between parenting status and depression , as well as PTSD , varied by duration of homelessness .
RESULTS	Among women who had been homeless for less than 2 years , no relationship was found between parenting status and depression , or PTSD .
RESULTS	However , among women who had been homeless for 2 or more years , the odds of depression was twice as high among parenting women compared with others ( aOR = 2.05 , p0 .05 ) .
RESULTS	A similar relationship was found between parenting status and PTSD ( aOR = 2.03 , p0 .05 ) .
RESULTS	The odds of substance dependence was found to be 2.62 times greater among parenting women compared with others and this relationship did not vary by duration of homelessness ( aOR = 2.62 ; 95 % CI 1.86 to 3.69 ) .
RESULTS	No relationship was found between parenting and alcohol dependence .
CONCLUSIONS	Overall , the findings from this study suggest that there is a relationship between long-term homelessness and mothers ' risk of poor mental health .
CONCLUSIONS	Given the multiple demands mothers face , a failure to recognise their unique needs is likely to contribute to intergenerational legacies of homelessness and mental health problems .
BACKGROUND	World Health Organization 's International Clinical Trials Registry Platform ( ISRCTN66721740 and ISRCTN57595077 ) .

###25171459
OBJECTIVE	To investigate the effectiveness of the Shikani optical stylet ( SOS ) and GlideScope video laryngoscope ( GVL ) for tracheal intubation of thyroid tumor patients with a difficult airway .
METHODS	One hundred and twenty thyroid tumor patients with a difficult airway , who were undergoing elective surgery requiring general anesthesia , were enrolled in the study .
METHODS	They were randomly allocated to 3 groups ( n = 40 each ) who underwent direct laryngoscopy ( DL ) , SOS or GVL .
METHODS	The outcomes recorded were time to intubation , first-attempt success rate , mean artery pressure ( MAP ) , heart rate ( HR ) and incidence of complications .
RESULTS	The mean time to intubation in the SOS group ( group S ; 42.4 24.1 s ) and the GLV group ( group G ; 29.8 22.3 s ) was significantly less than that in the DL group ( group D ) ( 68.8 26.6 s ) .
RESULTS	The first-attempt success rate in group S ( 90.0 % ) and group G ( 97.5 % ) was significantly higher than that in group D ( 75.0 % ; all p < 0.05 ) .
RESULTS	The HR and MAP at 1 min after intubation were lowest in group S ( 76.4 9.2 beats/min and 12.9 1.1 kPa ) , followed by group G ( 79.9 9.3 beats/min and 13.0 0.9 kPa ) and then group D ( 90.4 8.1 beats/min and 16.6 1.2 kPa ) .
RESULTS	The difference was statistically significant ( all p < 0.05 ) .
RESULTS	The incidence of lip or mucosal trauma was lowest in group S , followed by group G and then group D.
CONCLUSIONS	The SOS and the GLV had advantages over the DL in the management of thyroid tumor patients with a difficult airway in terms of a shorter time to intubation , a higher first-attempt success rate and a reduced incidence of complications .
CONCLUSIONS	Thus , a rational choice of one of these techniques may be better for the perioperative safety of thyroid tumor patients with a difficult airway .

###25096030
BACKGROUND	We aim to evaluate in-hospital events and long-term clinical outcomes in patients over 60 years of age with stable coronary artery disease and preserved left ventricular ejection fraction undergoing off-pump or on-pump coronary artery bypass grafting .
METHODS	The MASS III was a single-center randomized trial that evaluate 308 patients with stable coronary artery disease and preserved ventricular function assigned for : 155 to off-pump and 153 to on-pump CABG .
METHODS	Of this , 176 ( 58.3 % ) patients were 60 years or older at the time of randomization ( 90 of-pump and 86 on-pump ) .
METHODS	The primary short-term end point was a composite of myocardial infarction , stroke , and overall mortality occurring within 30 days after surgery or before discharge , whichever was later .
METHODS	The primary long-term end point was death from any cause within 5 years , non-fatal myocardial infarction between 30 days and 5 years , or additional revascularization between 30 days and 5 years .
RESULTS	On-pump CABG had a higher incidence of 30-day composite outcome than off-pump CABG ( 15,1 % and 5.6 % , respectively ; P = 0.036 ) .
RESULTS	However , after the multivariate analysis , this association lost statistical significance , P = 0.05 .
RESULTS	After 5-year follow-up , there were no significant differences between both strategies of CABG in the composite end points 16.7 % and 15.1 % ; Hazard Ratio 1.07 ; CI 0.41 - 1.82 ; P = 0.71 , for off-pump and on-pump CABG respectively .
CONCLUSIONS	On-pump and off-pump CABG achieved similar results of combined events at short-term and 5-year follow-up .
BACKGROUND	Clinical Trial Registration Information-URL : http://www.controlled-trials.com .
BACKGROUND	ISRCTN59539154 .

###26196502
BACKGROUND	The combination of daclatasvir , a hepatitis C virus ( HCV ) NS5A inhibitor , and the NS5B inhibitor sofosbuvir has shown efficacy in patients with HCV monoinfection .
BACKGROUND	Data are lacking on the efficacy and safety of this combination in patients coinfected with human immunodeficiency virus type 1 ( HIV-1 ) .
METHODS	This was an open-label study involving 151 patients who had not received HCV treatment and 52 previously treated patients , all of whom were coinfected with HIV-1 .
METHODS	Previously untreated patients were randomly assigned in a 2:1 ratio to receive either 12 weeks or 8 weeks of daclatasvir at a standard dose of 60 mg daily ( with dose adjustment for concomitant antiretroviral medications ) plus 400 mg of sofosbuvir daily .
METHODS	Previously treated patients were assigned to undergo 12 weeks of therapy at the same doses .
METHODS	The primary end point was a sustained virologic response at week 12 after the end of therapy among previously untreated patients with HCV genotype 1 who were treated for 12 weeks .
RESULTS	Patients had HCV genotypes 1 through 4 ( 83 % with genotype 1 ) , and 14 % had compensated cirrhosis ; 98 % were receiving antiretroviral therapy .
RESULTS	Among patients with genotype 1 , a sustained virologic response was reported in 96.4 % ( 95 % confidence interval [ CI ] , 89.8 to 99.2 ) who were treated for 12 weeks and in 75.6 % ( 95 % CI , 59.7 to 87.6 ) who were treated for 8 weeks among previously untreated patients and in 97.7 % ( 95 % CI , 88.0 to 99.9 ) who were treated for 12 weeks among previously treated patients .
RESULTS	Rates of sustained virologic response across all genotypes were 97.0 % ( 95 % CI , 91.6 to 99.4 ) , 76.0 % ( 95 % CI , 61.8 to 86.9 ) , and 98.1 % ( 95 % CI , 89.7 to 100 ) , respectively .
RESULTS	The most common adverse events were fatigue , nausea , and headache .
RESULTS	There were no study-drug discontinuations because of adverse events .
RESULTS	HIV-1 suppression was not compromised .
CONCLUSIONS	Among previously untreated HIV-HCV coinfected patients receiving daclatasvir plus sofosbuvir for HCV infection , the rate of sustained virologic response across all genotypes was 97.0 % after 12 weeks of treatment and 76.0 % after 8 weeks .
CONCLUSIONS	( Funded by Bristol-Myers Squibb ; ALLY-2 ClinicalTrials.gov number , NCT02032888 . )

###24472478
OBJECTIVE	Data on chemotherapy regimens in elderly patients with metastatic breast cancer ( MBC ) are limited .
OBJECTIVE	The aim of this retrospective pooled analysis was to determine efficacy and safety of ixabepilone plus capecitabine versus capecitabine alone in patients with MBC aged 65 years .
METHODS	A total of 1973 patients with MBC previously treated with or resistant to anthracyclines and taxanes were randomized in two open-label , multinational , phase 3 studies ( study 046 and study 048 ) .
METHODS	Patients received ixabepilone ( 40 mg/m ( 2 ) as a 3-hour intravenous infusion every 3 weeks ) plus oral capecitabine ( 1000 mg/m ( 2 ) administered twice each day ) , or capecitabine alone ( 1250 mg/m ( 2 ) twice each day ) .
RESULTS	In total , 251 randomized patients were aged 65 years ( ixabepilone plus capecitabine , n = 116 ; capecitabine monotherapy , n = 135 ) .
RESULTS	Efficacy results were consistent in patients aged < 65 and 65 years with respect to the observed improvement in progression-free survival and objective response rate with ixabepilone plus capecitabine compared with capecitabine alone .
RESULTS	No significant differences in overall survival between arms were observed for either subgroup .
RESULTS	In the ixabepilone plus capecitabine arm , grade 3/4 hematologic adverse events ( AEs ) were similar in both subgroups except leukopenia and febrile neutropenia , which had a higher incidence in patients aged 65 years .
RESULTS	The majority of grade 3/4 nonhematologic AEs were similar in the two subgroups , including fatigue , peripheral sensory neuropathy , and hand-foot syndrome .
CONCLUSIONS	The combination of ixabepilone plus capecitabine maintains its efficacy in elderly patients with anthracycline and taxane pretreated MBC , with a similar safety profile to patients aged < 65 years .

###24342530
OBJECTIVE	Excessive shortening of the telomeric ends of chromosomes is a marker of accelerated aging .
OBJECTIVE	Oxidative stress and nutritional deficiency may influence this process .
OBJECTIVE	The aim of this study was to investigate the effect of -3 polyunsaturated fatty acid ( -3 PUFA ) supplementation on telomeric shortening in elderly individuals with mild cognitive impairment ( MCI ) .
METHODS	Thirty-three adults ages > 65 y with MCI were randomized to receive a supplement rich in the long-chain -3 PUFAs eicosapentaenoic acid ( EPA ; 1.67 g EPA + 0.16 g docosahexaenoic acid DHA/d ; n = 12 ) or DHA ( 1.55 g DHA + 0.40 g EPA/d ; n = 12 ) , versus -6 PUFA linoleic acid ( LA ; 2.2 g/d ; n = 9 ) for 6 mo. .
RESULTS	The intervention did not show an increase in telomere length with treatment and there was a trend toward telomere shortening during the intervention period .
RESULTS	Linear mixed modeling produced a robust model although statistically underpowered .
RESULTS	Telomere shortening was greatest in the LA group ( d = 0.21 ) than in the DHA ( d = 0.12 ) and EPA groups ( d = 0.06 ) .
RESULTS	Increased erythrocyte DHA levels were associated with reduced telomere shortening ( r = -0.67 ; P = 0.02 ) in the DHA group .
CONCLUSIONS	Telomeric shortening may be attenuated by -3 PUFA supplementation , requiring further investigation in larger samples .

###24889207
BACKGROUND	The relationship between inadequate sleep and mood has been well-established in adults and is supported primarily by correlational data in younger populations .
BACKGROUND	Given that adolescents often experience shortened sleep on school nights , we sought to better understand the effect of experimentally induced chronic sleep restriction on adolescents ' mood and mood regulation .
METHODS	Fifty healthy adolescents , ages 14-17 , completed a 3-week sleep manipulation protocol involving a baseline week , followed by a sleep restriction ( SR ) condition ( 6.5 hr in bed per night for five nights ) and healthy sleep duration ( HS ) condition ( 10 hr in bed per night for five nights ) .
METHODS	The study used a randomized , counterbalanced , crossover experimental design .
METHODS	Participants ' sleep was monitored at home via self-report and actigraphy .
METHODS	At the end of each condition , participants and their parents completed questionnaires of mood and mood regulation .
METHODS	To assess for expectancy effects , we also analyzed parent and teen ratings of hyperactivity/impulsivity , which prior research suggests is not sensitive to SR in adolescents .
METHODS	Wilcoxon Signed Rank tests compared questionnaire outcomes across the two conditions .
RESULTS	Participants averaged 2.5 more hours of sleep per night during HS relative to SR. .
RESULTS	Compared with HS , adolescents rated themselves as significantly more tense/anxious , angry/hostile , confused , and fatigued , and as less vigorous ( p = .001 -.01 ) during SR. .
RESULTS	Parents and adolescents also reported greater oppositionality/irritability and poorer emotional regulation during SR compared with HS ( p < .05 ) .
RESULTS	There were no cross-condition differences in depression or hyperactivity/impulsivity ( p > .05 ) .
CONCLUSIONS	Findings complement prior correlational study results to show that after only a few days of shortened sleep , at a level of severity that is experienced regularly by millions of adolescents on school nights , adolescents have worsened mood and decreased ability to regulate negative emotions .

###24794514
OBJECTIVE	This study aims ( 1 ) to develop an automated and fast approach for detecting visual evoked potentials ( VEPs ) in single trials and ( 2 ) to apply the single-trial VEP detection approach in designing a real-time and high-performance brain-computer interface ( BCI ) system .
METHODS	The single-trial VEP detection approach uses common spatial pattern ( CSP ) as a spatial filter and wavelet filtering ( WF ) a temporal-spectral filter to jointly enhance the signal-to-noise ratio ( SNR ) of single-trial VEPs .
METHODS	The performance of the joint spatial-temporal-spectral filtering approach was assessed in a four-command VEP-based BCI system .
RESULTS	The offline classification accuracy of the BCI system was significantly improved from 67.612.5 % ( raw data ) to 97.32.1 % ( data filtered by CSP and WF ) .
RESULTS	The proposed approach was successfully implemented in an online BCI system , where subjects could make 20 decisions in one minute with classification accuracy of 90 % .
CONCLUSIONS	The proposed single-trial detection approach is able to obtain robust and reliable VEP waveform in an automatic and fast way and it is applicable in VEP based online BCI systems .
CONCLUSIONS	This approach provides a real-time and automated solution for single-trial detection of evoked potentials or event-related potentials ( EPs/ERPs ) in various paradigms , which could benefit many applications such as BCI and intraoperative monitoring .

###24834504
OBJECTIVE	To evaluate the changes occurring in the subgingival microbial profile of subjects with generalized chronic periodontitis ( ChP ) treated by scaling and root planing ( SRP ) alone or with metronidazole ( MTZ ) or MTZ + amoxicillin ( AMX ) .
OBJECTIVE	A secondary aim was to examine a possible added effect of chlorhexidine ( CHX ) to these therapies .
METHODS	One hundred and eighteen subjects were randomly assigned to receive SRP-only or with MTZ [ 400 mg/thrice a day ( TID ) ] or MTZ + AMX ( 500 mg/TID ) for 14 days .
METHODS	Half of the subjects in each group rinsed with 0.12 % CHX twice a day ( BID ) for 2 months .
METHODS	Nine subgingival plaque samples/subject were analysed by checkerboard DNADNA hybridization for 40 bacterial species at baseline , 3 , 6 and 12 months post-therapy .
RESULTS	At 12 months , the antibiotic-treated groups harboured lower mean counts and proportions of key periodontal pathogens than the SRP group ( p < 0.05 ) .
RESULTS	These benefits were observed at initially deep and shallow sites .
RESULTS	Initial reductions in periodontal pathogens obtained with SRP partially rebound after 12 months .
RESULTS	CHX rinsing enhanced the microbiological effects of the MTZ + AMX treatment in shallow sites .
CONCLUSIONS	The adjunctive use of MTZ and MTZ + AMX results in a greater reduction in the levels of periodontal pathogens in generalized ChP subjects compared to SRP alone .

###24249842
OBJECTIVE	Assessment of feasibility and effects of an exercise training programme in patients following cystectomy due to urinary bladder cancer .
METHODS	Single-blind , pilot , randomized controlled trial .
METHODS	University hospital , Sweden .
METHODS	Eighteen patients ( 64-78 years ) , of 89 suitable , cystectomized due to urinary bladder cancer , were randomized after hospital discharge to intervention or control .
METHODS	The 12-week exercise programme included group exercise training twice a week and daily walks .
METHODS	The control group received only standardized information at discharge .
METHODS	Trial eligibility and compliance to inclusion were registered .
METHODS	Assessments of functional capacity , balance , lower body strength and health-related quality of life ( HRQoL ) with SF-36 .
RESULTS	Out of 122 patients 89 were eligible , but 64 did not want to participate/were not invited .
RESULTS	Twenty-five patients were included , but 7 dropped out before randomization .
RESULTS	Eighteen patients were randomized to intervention or control .
RESULTS	Thirteen patients completed the training period .
RESULTS	The intervention group increased walking distance more than the control group , 109 m ( 75-177 ) compared to 62 m ( 36-119 ) ( P = 0.013 ) , and role physical domain in SF-36 more than the control group ( P = 0.031 ) .
RESULTS	Ten patients were evaluated one year postoperatively .
RESULTS	The intervention group had continued increasing walking distance , 20 m ( 19-36 ) , whereas the control group had shortened the distance -15.5 m ( -43 to -5 ) ( P = 0.010 ) .
CONCLUSIONS	A 12-week group exercise training programme was not feasible for most cystectomy patients .
CONCLUSIONS	However , functional capacity and the role-physical domain in HRQoL increased in the short and long term for patients in the intervention group compared with controls .

###25133996
OBJECTIVE	Using three separate models that included total body mass , total lean and total fat mass , and abdominal and thigh fat as independent measures , we determined their association with knee joint loads in older overweight and obese adults with knee osteoarthritis ( OA ) .
METHODS	Fat depots were quantified using computed tomography , and total lean and fat mass were determined with dual energy x-ray absorptiometry in 176 adults ( age , 66.3 yr ; body mass index , 33.5 kgm ) with radiographic knee OA .
METHODS	Knee moments and joint bone-on-bone forces were calculated using gait analysis and musculoskeletal modeling .
RESULTS	Higher total body mass was significantly associated ( P 0.0001 ) with greater knee compressive and shear forces , compressive and shear impulses ( P < 0.0001 ) , patellofemoral forces ( P < 0.006 ) , and knee extensor moments ( P = 0.003 ) .
RESULTS	Regression analysis with total lean and total fat mass as independent variables revealed significant positive associations of total fat mass with knee compressive ( P = 0.0001 ) , shear ( P < 0.001 ) , and patellofemoral forces ( P = 0.01 ) and knee extension moment ( P = 0.008 ) .
RESULTS	Gastrocnemius and quadriceps forces were positively associated with total fat mass .
RESULTS	Total lean mass was associated with knee compressive force ( P = 0.002 ) .
RESULTS	A regression model that included total thigh and total abdominal fat found that both were significantly associated with knee compressive and shear forces ( P 0.04 ) .
RESULTS	Thigh fat was associated with knee abduction ( P = 0.03 ) and knee extension moment ( P = 0.02 ) .
CONCLUSIONS	Thigh fat , consisting predominately of subcutaneous fat , had similar significant associations with knee joint forces as abdominal fat despite its much smaller volume and could be an important therapeutic target for people with knee OA .

###24316514
OBJECTIVE	Serelaxin is effective in relieving dyspnoea and improving multiple outcomes in acute heart failure ( AHF ) .
OBJECTIVE	Many AHF patients have preserved ejection fraction ( HFpEF ) .
OBJECTIVE	Given the lack of evidence-based therapies in this population , we evaluated the effects of serelaxin according to EF in RELAX-AHF trial .
RESULTS	RELAX-AHF randomized 1161 AHF patients to 48-h serelaxin ( 30 g/kg/day ) or placebo within 16 h from presentation .
RESULTS	We compared the effects of serelaxin on efficacy endpoints , safety endpoints , and biomarkers of organ damage between preserved ( 50 % ) and reduced ( < 50 % , HFrEF ) EF .
RESULTS	HFpEF was present in 26 % of patients .
RESULTS	Serelaxin induced a similar dyspnoea relief in HFpEF vs. HFrEF patients by visual analogue scale-area under the curve ( VAS-AUC ) through Day 5 [ mean change , 461 ( -195 , 1117 ) vs. 397 ( 10 , 783 ) mm h , P = 0.87 ] , but had possibly different effects on the proportion of patients with moderately or markedly dyspnoea improvement by Likert scale at 6 , 12 , and 24 h [ odds ratio for favourable response , 1.70 ( 0.98 , 2.95 ) vs. 0.85 ( 0.62 , 1.15 ) , interaction P = 0.030 ] .
RESULTS	No differences were encountered in the effect of serelaxin on short - or long-term outcome between HFpEF and HFrEF patients including cardiovascular death or hospitalization for heart/renal failure through Day 60 , cardiovascular death through Day 180 , and all-cause death through Day 180 .
RESULTS	Similar safety and changes in biomarkers ( high-sensitivity troponin T , cystatin-C , and alanine/aspartate aminotransferases ) were found in both groups .
CONCLUSIONS	In AHF patients with HFpEF compared with those with HFrEF , serelaxin was well tolerated and effective in relieving dyspnoea and had a similar effect on short - and long-term outcome , including survival improvement .

###25335247
OBJECTIVE	To compare the difference in the clinical efficacy on post-stroke insomnia between the low-frequency electric stimulation at the acupoints and the conventional western medication .
METHODS	One hundred and twenty patients of post-stroke insomnia were randomized into a low-frequency electric stimulation group , a medication group and a placebo group , 40 cases in each one .
METHODS	In the low-frequency electric stimulation group , the low-frequency electric-pulsing apparatus was used at Dazhui ( GV 14 ) and Shenshu ( BL 23 ) , once a day ; the treatment of 15 days made one session and 2 sessions were required .
METHODS	In the medication group , estazolam was taken orally , 1 mg each time .
METHODS	In the placebo group , starch capsules were taken orally , 1 capsule each time .
METHODS	All the drugs were taken before sleep every night , continuously for 15 days as one session , and 2 sessions were required .
METHODS	PSQI changes and clinical efficacy were observed before and after treatment in each group .
RESULTS	Pitlsburgh sleep quality index ( PSQI ) score was reduced in every group after treatment ( all P < 0.01 ) .
RESULTS	In the low-frequency electric stimulation group and medication group , the score was reduced much more significantly as compared with the placebo group ( both P < 0.01 ) .
RESULTS	In the placebo group , 1 case was rejected .
RESULTS	The total effective rates were 95.0 % ( 38/40 ) , 92.5 % ( 37/40 ) and 17.9 % ( 7/39 ) in the low-frequency electric stimulation group , medication group and placebo group separately .
RESULTS	The efficacy in the low-frequency electric stimulation group and medication group was better apparently than that in the placebo group ( both P < 0.01 ) .
CONCLUSIONS	The low-frequency electric stimulation at the acupoints effectively and safely treats post-stroke insomnia and the efficacy of it is similar to that of estazolam .

###24297763
BACKGROUND	Individuals with chronic stroke often have long-lasting upper extremity impairments that impede function during activities of daily living .
BACKGROUND	Rehabilitation robotics have shown promise in improving arm function , but current systems do not allow realistic training of activities of daily living .
BACKGROUND	We have incorporated the ARMin III and HandSOME device into a novel robotic therapy modality that provides functional training of reach and grasp tasks .
OBJECTIVE	To compare the effects of equal doses of robotic and conventional therapy in individuals with chronic stroke .
METHODS	Subjects were randomized to 12 hours of robotic or conventional therapy and then crossed over to the other therapy type after a 1-month washout period .
METHODS	Twelve moderate to severely impaired individuals with chronic stroke were enrolled , and 10 completed the study .
RESULTS	Across the 3-month study period , subjects showed significant improvements in the Fugl-Meyer ( P = .013 ) and Box and Blocks tests ( P = .028 ) .
RESULTS	The robotic intervention produced significantly greater improvements in the Action Research Arm Test than conventional therapy ( P = .033 ) .
RESULTS	Gains in the Box and Blocks test from conventional therapy were larger than from robotic therapy in subjects who received conventional therapy after robotic therapy ( P = .044 ) .
CONCLUSIONS	Data suggest that robotic therapy can elicit improvements in arm function that are distinct from conventional therapy and supplements conventional methods to improve outcomes .
CONCLUSIONS	Results from this pilot study should be confirmed in a larger study .

###24643430
OBJECTIVE	To examine and compare systemic arterial stiffness responses in humans to acute continuous and interval low-intensity exercise .
METHODS	Fifteen healthy young men ( 21.20.4 years ) underwent non-exercise control ( CON ) , continuous exercise ( CE ) , and interval exercise trial ( IE ) in a randomized balanced self-control crossover design .
METHODS	Systemic arterial stiffness ( Cardio-ankle vascular index , CAVI ) was measured at baseline ( BL ) , immediately after ( 0min ) and 40min after exercise in CE and IE trials , and at corresponding time points in CON trial .
METHODS	Subjects cycled continuously for 30min at 35 % heart rate reserve after BL measurement in CE trial , whereas in IE trial , subjects cycled two bouts of 15-min separated by a 20-min rest at the same intensity .
RESULTS	There were no significant CAVI changes with time in CON trial ( 6.70.1 , 6.70.1 , 6.60.1 at BL , 0 and 40min , respectively ) .
RESULTS	In CE trial , CAVI decreased immediately after exercise ( 0min ) and returned to baseline after 40min of recovery ( 6.50.1 , 5.50.2 , 6.40.1 at BL , 0 and 40min , respectively ) .
RESULTS	IE elicited similar CAVI reduction from 6.70.1 at baseline to 5.60.2 at 0min : however , CAVI at 40min remained significantly low compared to that of CON trial at corresponding time point ( 6.00.1 vs. 6.60.1 , P < 0.001 ) .
CONCLUSIONS	Both acute continuous and interval low-intensity exercise elicits transient improvement in systemic arterial stiffness in humans .
CONCLUSIONS	Despite equivalent exercise intensity and duration , interval exercise resulted in improved arterial stiffness for longer duration .

###24645970
BACKGROUND	Ablative 10,600-nm carbon dioxide ( CO2 ) fractional laser treatments have shown favorable outcomes for atrophic acne scars .
OBJECTIVE	To compare the efficacy and complications of fractional CO2 laser treatments with different fluences and densities for acne scars .
METHODS	Twenty patients were treated using a single session of fractional CO2 laser in Deep FX mode .
METHODS	In Group A ( n = 10 ) , half of the face was treated with 20mJ , density 10 % and the other half with 20mJ , density 20 % .
METHODS	In Group B ( n = 10 ) , half of the face was treated with 10mJ , density 10 % and the other half with 20mJ , density 10 % .
METHODS	Patients were evaluated at baseline and 3days , 1week , 1month , and 3months after the procedure .
RESULTS	There was no significant difference in efficacy between different laser settings within the groups , although adverse effects were more evident in patients treated with higher densities or fluences .
CONCLUSIONS	Factional CO2 laser treatment using the Deep FX mode may provide a significant efficacy with lower fluence and density with fewer complications than with higher energies for acne scars .

###24997137
OBJECTIVE	This randomized phase II study assessed the efficacy and safety of obatoclax mesylate , a small-molecule Bcl-2 inhibitor , added to carboplatin/etoposide chemotherapy as initial treatment for extensive-stage small-cell lung cancer ( ES-SCLC ) .
METHODS	Chemotherapy-nave subjects with ES-SCLC and Eastern Cooperative Oncology Group performance status ( ECOG PS ) 0-2 received carboplatin/etoposide with ( CbEOb ) or without ( CbE ) obatoclax for up to six cycles .
METHODS	Responders to CbEOb could receive maintenance obatoclax until disease progression .
METHODS	The primary endpoint was objective response rate ( ORR ) .
RESULTS	155 subjects ( median age 62 , 58 % male , 10 % ECOG PS 2 ) were treated with CbEOb ( n = 77 ) or CbE ( n = 78 ) ; 65 % and 59 % of subjects , respectively , completed six cycles .
RESULTS	ORR was 62 % with CbEOb versus 53 % with CbE ( 1-sided p = 0.143 ) .
RESULTS	Clinical benefit ( ORR + stable disease ) trended better with CbEOb ( 81 % versus 68 % ; p = 0.054 ) .
RESULTS	Median progression-free survival ( PFS ) and overall survival ( OS ) were 5.8 months ( 95 % confidence interval [ CI ] : 5.3-6 .5 ) and 10.5 months ( 8.9-13 .8 ) with CbEOb and 5.2 months ( 95 % CI : 4.1-5 .7 ) and 9.8 months ( 7.2-11 .2 ) with CbE .
RESULTS	Median OS was 10.5 months ( 95 % CI : 8.9-13 .8 ) and 9.8 months ( 7.2-11 .2 ) with a nonsignificant hazard ratio for OS , 0.823 ; 1-sided p = 0.121 .
RESULTS	Grade 3/4 adverse events ( AEs ) were primarily hematologic and similar in frequency between treatment arms .
RESULTS	Obatoclax-related somnolence and euphoria were grade 1/2 , transient , and did not require treatment discontinuation .
CONCLUSIONS	Obatoclax was well tolerated when added to carboplatin/etoposide in first-line treatment of ES-SCLC , but failed to significantly improve ORR , PFS , or OS .

###24519200
OBJECTIVE	Hyperhidrosis is a common disease , and thoracoscopic sympathectomy improves its symptoms in up to 95 % of cases .
OBJECTIVE	Unfortunately , after surgery , plantar hyperhidrosis may remain in 50 % of patients , and compensatory sweating may be observed in 70 % .
OBJECTIVE	This clinical scenario remains a challenge .
OBJECTIVE	Our objective was to evaluate the effectiveness of oxybutynin in the treatment of persistent plantar hyperhidrosis and compensatory sweating and its effects on quality of life in women after thoracoscopic sympathectomy .
METHODS	We conducted a prospective , randomized study to compare the effects of oxybutynin at 10 mg daily and placebo in women with persistent plantar hyperhidrosis .
METHODS	The assessment was performed using a quality-of-life questionnaire for hyperhidrosis and sweating measurement with a device for quantifying transepidermal water loss .
METHODS	Clinicaltrials.gov : NCT01328015 .
RESULTS	Sixteen patients were included in each group ( placebo and oxybutynin ) .
RESULTS	There were no significant differences between the groups prior to treatment .
RESULTS	After oxybutynin treatment , there was a decrease in symptoms and clinical improvement based on the quality-of-life questionnaire ( before treatment , 40.4 vs. after treatment , 17.5 ; p = 0.001 ) .
RESULTS	The placebo group showed modest improvement ( p = 0.09 ) .
RESULTS	The outcomes of the transepidermal water loss measurements in the placebo group showed no differences ( p = 0.95 ) , whereas the oxybutynin group revealed a significant decrease ( p = 0.001 ) .
RESULTS	The most common side effect was dry mouth ( 100 % in the oxybutynin group vs. 43.8 % in the placebo group ; p = 0.001 ) .
CONCLUSIONS	Oxybutynin was effective in the treatment of persistent plantar hyperhidrosis , resulting in a better quality of life in women who had undergone thoracoscopic sympathectomy .

###24252845
BACKGROUND	The erythrocyte membrane content of eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) , which constitutes the omega-3 index ( O3I ) , predicts cardiovascular disease mortality .
BACKGROUND	The amount of EPA+DHA needed to achieve a target O3I is poorly defined , as are the determinants of the O3I response to a change in EPA+DHA intake .
BACKGROUND	The objective of this study was to develop a predictive model of the O3I response to EPA+DHA supplementation in healthy adults , specifically identifying factors that determine the response .
RESULTS	A randomized , placebo-controlled , double-blind , parallel-group study was conducted in 115 healthy men and women .
RESULTS	One of 5 doses ( 0 , 300 , 600 , 900 , 1800 mg ) of EPA+DHA was given daily as placebo or fish oil supplements for 5 months .
RESULTS	The O3I was measured at baseline and at the end of the study .
RESULTS	There were no significant differences in the clinical characteristics between the groups at baseline .
RESULTS	The O3I increased in a dose-dependent manner ( P < 0.0001 ) , with the dose of EPA+DHA alone accounting for 68 % ( quadratic , P < 0.0001 ) of the variability in the O3I response .
RESULTS	Dose adjusted per unit body weight ( g/kg ) accounted for 70 % ( linear , P < 0.0001 ) .
RESULTS	Additional factors that improved prediction of treatment response were baseline O3I , age , sex , and physical activity .
RESULTS	Collectively , these explained 78 % of the response variability ( P < 0.0001 ) .
CONCLUSIONS	Our findings validate the O3I as a biomarker of EPA+DHA consumption and identify additional factors , particularly body weight , that can be used to tailor EPA+DHA recommendations to achieve a target O3I .

###25732161
OBJECTIVE	In metastatic or recurrent cervical cancer , cisplatin-based chemotherapy is standard .
OBJECTIVE	The JCOG0505 randomized phase III trial evaluated the clinical benefits of carboplatin-based regimen .
METHODS	Eligible patients had metastatic or recurrent cervical cancer and had one platinum-containing treatment and no prior taxane .
METHODS	Patients were randomly assigned either to conventional paclitaxel plus cisplatin ( TP ; paclitaxel 135 mg/m ( 2 ) over 24 hours on day 1 and cisplatin 50 mg/m ( 2 ) on day 2 , repeated every 3 weeks ) or paclitaxel plus carboplatin ( TC ; paclitaxel 175 mg/m ( 2 ) over 3 hours and carboplatin area under curve 5 mg/mL/min on day 1 , repeated every 3 weeks ) .
METHODS	Primary end point was overall survival ( OS ) .
METHODS	Planned sample size was 250 patients to confirm the noninferiority of TC versus TP with the threshold hazard ratio ( HR ) of 1.29 .
RESULTS	Between February 2006 and November 2009 , 253 patients were enrolled .
RESULTS	The HR of OS was 0.994 ( 90 % CI , 0.79 to 1.25 ; noninferiority P = .032 by stratified Cox regression ) .
RESULTS	Median OS was 18.3 months with TP versus 17.5 months with TC .
RESULTS	Among patients who had not received prior cisplatin , OS was shorter with TC ( 13.0 v 23.2 months ; HR , 1.571 ; 95 % CI , 1.06 to 2.32 ) .
RESULTS	One treatment-related death occurred with TC .
RESULTS	Proportion of nonhospitalization periods was significantly longer with TC ( P < .001 ) .
CONCLUSIONS	TC was noninferior to TP and should be a standard treatment option for metastatic or recurrent cervical cancer .
CONCLUSIONS	However , cisplatin is still the key drug for patients who have not received platinum agents .

###25350959
OBJECTIVE	To assess the efficacy and safety of lersivirine versus etravirine in patients with HIV-1 and prior non-nucleoside reverse transcriptase inhibitor ( NNRTI ) use and evidence of NNRTI resistance .
METHODS	In this 96-week , phase 2b study , 97 patients were randomized and treated with lersivirine 750 mg qd ( n = 31 ) , lersivirine 1,000 mg qd ( n = 32 ) , and etravirine 200 mg bid ( n = 34 ) , plus one optimized nucleoside reverse transcriptase inhibitor and darunavir/ritonavir 600/100 mg bid .
METHODS	The primary endpoint was the percentage of patients with HIV-1 RNA < 50 copies/mL at week 24 .
RESULTS	At week 24 , HIV-1 RNA < 50 copies/mL was achieved by fewer patients receiving lersivirine 750 mg ( 48.4 % ) and 1,000 mg ( 43.8 % ) qd compared with etravirine 200 mg qd ( 67.7 % ) ( intention to treat [ ITT ] , missing/switch/discontinuation equals failure [ MSDF ] ) .
RESULTS	At week 48 , HIV-1 RNA < 50 copies/mL and < 400 copies/mL were also achieved by fewer patients receiving lersivirine 750 mg ( 41.9 % and 41.9 % , respectively ) and 1,000 mg ( 31.3 % and 34.4 % , respectively ) qd compared with etravirine 200 mg bid ( 61.8 % and 70.6 % , respectively ) ( ITT , MSDF ) .
RESULTS	Least squares means ( SE ) change from baseline in log transformed HIV-1 RNA at week 48 was -1.42 ( 0.27 ) and -0.95 ( 0.28 ) copies/mL for lersivirine 750 mg and 1,000 mg qd , respectively , versus -2.02 ( 0.26 ) copies/mL for etravirine 200 mg bid ( ITT ) .
RESULTS	Lersivirine and etravirine were generally safe and well-tolerated .
CONCLUSIONS	Lersivirine 750 mg and 1,000 mg qd was associated with lower rates of viral suppression at week 24 and week 48 versus etravirine in patients with prior NNRTI use and evidence of NNRTI resistance .
CONCLUSIONS	No new safety signals were detected .

###24637568
METHODS	A double-blinded randomized clinical trial .
OBJECTIVE	The anti-inflammatory and neuroprotective effect of omega-3 fatty acids have been shown so far , but still its influence on clinical measures in spinal cord-injured human models were not known .
OBJECTIVE	We tried to investigate changes in disability and dependency scores in chronic traumatic spinal cord-injured patients after 14 months of -3 fatty-acid consumption .
METHODS	Main inclusion criteria were : traumatic spinal cord injury ( SCI ) and post injury duration longer than 1 year .
METHODS	Disability and dependency was assessed using U.K Functional Independence Measure and Functional Assessment Measure ( FIM+FAM ) scale .
METHODS	MorDHA capsules ( 435mg of docosahexaenoic acid and 65mg of eicosapentaenoic acid ) were administered in treatment group , whereas control group received placebo capsules for 14 months .
METHODS	U.K. FIM+FAM scale were estimated before intervention and at the end of the trial .
RESULTS	Fifty-four patients in treatment group and 50 patients in placebo group completed the trial .
RESULTS	Highest scores were detected in cognitive domain in both groups before and after intervention .
RESULTS	Most dependency was observed in locomotion subscale and secondly in sphincter control .
RESULTS	Scores of none of these components were changed by -3 fatty-acid consumption .
CONCLUSIONS	Although omega-3 fatty acids have been shown to have neuroprotective effect in acute phase of SCI , it seems that they have no significant influence in chronic inflammatory state of SCI .
CONCLUSIONS	The positive effect of -3 fatty acid in chronic neurorecovery process , if exists , is weaker to exert any significant improvement in UK FIM+FAM scores in spinal cord-injured individuals .

###24810491
BACKGROUND	WHO guidelines recommend early initiation of antiretroviral therapy ( ART ) irrespective of CD4 cell count for all patients with tuberculosis who also have HIV , but evidence supporting this approach is poor quality .
BACKGROUND	We assessed the effect of timing of ART initiation on tuberculosis treatment outcomes for HIV-positive patients with CD4 counts of 220 cells per L or more .
METHODS	We did this randomised , placebo-controlled trial between Jan 1 , 2008 , and April 31 , 2013 at 26 treatment centres in South Africa , Tanzania , Uganda , and Zambia .
METHODS	We enrolled HIV-positive patients with culture-confirmed tuberculosis who had tolerated 2 weeks of tuberculosis short course chemotherapy .
METHODS	Participants were randomly allocated ( 1:1 ) to early ART ( starting after 2 weeks of tuberculosis treatment ) or delayed ART ( placebo , then starting ART at the end of 6 months of tuberculosis treatment ) .
METHODS	Randomisation was computer generated , with permuted blocks of size eight , and stratified by CD4 count ( 220-349 cells per L vs 350 cells per L ) .
METHODS	Patients and investigators were masked to treatment allocation until completion of 6-months ' tuberculosis treatment , after which the study was open label .
METHODS	The primary endpoint was a composite of failure of tuberculosis treatment , tuberculosis recurrence , and death within 12 months of starting tuberculosis treatment in the modified intention-to-treat population .
METHODS	Secondary endpoints included mortality .
METHODS	The study is registered with controlled-trials .
METHODS	com ( ISRCTN77861053 ) .
RESULTS	We screened 13,588 patients and enrolled 1675 : 834 assigned early ART , 841 delayed ART .
RESULTS	The primary endpoint was reached by 65 ( 85 % ) of 767 patients in the early ART group versus 71 ( 92 % ) of 771 in the delayed ART group ( relative risk [ RR ] 091 , 95 % CI 064-130 ; p = 09 ) .
RESULTS	Of patients with a CD4 cell count of 220-349 cells per L , 26 ( 79 % ) of 331 patients versus 33 ( 96 % ) of 342 reached the primary endpoint ( RR 080 , 95 % CI 046-139 ; p = 06 ) .
RESULTS	For those with 350 cells per L or more , 39 ( 89 % ) of 436 versus 38 ( 89 % ) of 429 reached the primary endpoint ( RR 101 , 95 % CI 063-162 ; p = 04 ) .
RESULTS	Mortality did not differ significantly between treatment groups ( RR 14 , 95 % CI 08-23 ; p = 023 ) .
RESULTS	Grade 3 and 4 adverse events occurred in 149 ( 18 % ) of 834 patients assigned early ART versus 174 ( 21 % ) of 841 assigned delayed ART ( p = 037 ) .
RESULTS	87 ( 10 % ) of 834 versus 84 ( 10 % ) of 841 had immune reconstitution inflammatory syndrome ( p = 056 ) .
CONCLUSIONS	ART can be delayed until after completion of 6 months of tuberculosis treatment for HIV-positive patients with tuberculosis who have CD4 cell counts greater than 220 cells per L.
CONCLUSIONS	WHO guidelines should be updated accordingly .
BACKGROUND	USAID , Zambia Ministry of Health , Tanzania Commission for Science and Technology , WHO-TDR .

###24922488
OBJECTIVE	Neurofeedback aims to reduce symptoms of attention-deficit/hyperactivity disorder ( ADHD ) , mainly attention problems .
OBJECTIVE	However , the additional influence of neurofeedback over treatment as usual ( TAU ) on neurocognitive functioning for adolescents with ADHD remains unclear .
METHODS	By using a multicenter parallel randomized controlled trial ( RCT ) design , male adolescents with a DSM-IV-TR diagnosis of ADHD ( mean age = 16.1 years ; range , 12-24 ) were randomized to receive either a combination of TAU and neurofeedback ( n = 45 ) or TAU ( n = 26 ) .
METHODS	Randomization was computer generated and stratified by age group ( ages 12 through 15 , 16 through 20 , and 21 through 24 years ) .
METHODS	The neurofeedback intervention consisted of approximately 37 sessions over a period of 25 weeks of theta/sensorimotor rhythm training on the vertex ( Cz ) .
METHODS	Primary neurocognitive outcomes included performance parameters derived from the D2 Test of Attention , the Digit Span backward , the Stroop Color-Word Test and the Tower of London , all assessed preintervention and postintervention .
METHODS	Data were collected between December 2009 and July 2012 .
RESULTS	At postintervention , outcomes of attention and/or motor speed were improved , with faster processing times for both intervention conditions and with medium to large effect sizes ( range , p2 = .08 -.54 ; P values < .023 ) .
RESULTS	In both groups , no improvements for higher executive functions were observed .
RESULTS	Results might partly resemble practice effects .
CONCLUSIONS	Although neurocognitive outcomes improved in all adolescents receiving treatment for ADHD , no additional value for neurofeedback over TAU was observed .
CONCLUSIONS	Hence , this study does not provide evidence for using theta/sensorimotor rhythm neurofeedback to enhance neurocognitive performance as additional intervention to TAU for adolescents with ADHD symptoms .
BACKGROUND	Trialregister.nl identifier : 1759 .

###24530176
BACKGROUND	High blood pressure is a prognostic factor for acute stroke , but blood pressure variability might also independently predict outcome .
BACKGROUND	We assessed the prognostic value of blood pressure variability in participants of INTERACT2 , an open-label randomised controlled trial ( ClinicalTrials.gov number NCT00716079 ) .
METHODS	INTERACT2 enrolled 2839 adults with spontaneous intracerebral haemorrhage ( ICH ) and high systolic blood pressure ( 150-220 mm Hg ) without a definite indication or contraindication to early intensive treatment to reduce blood pressure .
METHODS	Participants were randomly assigned to intensive treatment ( target systolic blood pressure < 140 mm Hg within 1 h using locally available intravenous drugs ) or guideline-recommended treatment ( target systolic blood pressure < 180 mm Hg ) within 6 h of onset of ICH .
METHODS	The primary outcome was death or major disability at 90 days ( modified Rankin Scale score 3 ) and the secondary outcome was an ordinal shift in modified Rankin Scale scores at 90 days , assessed by investigators masked to treatment allocation .
METHODS	Blood pressure variability was defined according to standard criteria : five measurements were taken in the first 24 h ( hyperacute phase ) and 12 over days 2-7 ( acute phase ) .
METHODS	We estimated associations between blood pressure variability and outcomes with logistic and proportional odds regression models .
METHODS	The key parameter for blood pressure variability was standard deviation ( SD ) of systolic blood pressure , categorised into quintiles .
RESULTS	We studied 2645 ( 932 % ) participants in the hyperacute phase and 2347 ( 827 % ) in the acute phase .
RESULTS	In both treatment cohorts combined , SD of systolic blood pressure had a significant linear association with the primary outcome for both the hyperacute phase ( highest quintile adjusted OR 141 , 95 % CI 105-190 ; ptrend = 00167 ) and the acute phase ( highest quintile adjusted OR 157 , 95 % CI 114-217 ; ptrend = 00124 ) .
RESULTS	The strongest predictors of outcome were maximum systolic blood pressure in the hyperacute phase and SD of systolic blood pressure in the acute phase .
RESULTS	Associations were similar for the secondary outcome ( for the hyperacute phase , highest quintile adjusted OR 143 , 95 % CI 114-180 ; ptrend = 00014 ; for the acute phase OR 146 , 95 % CI 113-188 ; ptrend = 00044 ) .
CONCLUSIONS	Systolic blood pressure variability seems to predict a poor outcome in patients with acute intracerebral haemorrhage .
CONCLUSIONS	The benefits of early treatment to reduce systolic blood pressure to 140 mm Hg might be enhanced by smooth and sustained control , and particularly by avoiding peaks in systolic blood pressure .
BACKGROUND	National Health and Medical Research Council of Australia .

###24277404
OBJECTIVE	To investigate the ideal digestive tract reconstruction methods among three different surgical methods after radical gastrectomy of gastric cancer patients .
METHODS	A total of 123 patients who received elective radical gastrectomy for gastric cancer from February 2010 to August 2011 were prospectively enrolled and randomly divided into radical proximal gastrectomy and jejunal interposition group , radical proximal gastrectomy and esophageal with the posterior of residual-stomach group , and radical total gastrectomy and Roux-en-Y esophagojejunostomy group .
METHODS	Patients were followed up for 12 months .
METHODS	Symptoms of reflux esophagitis were observed , gastric emptying tests were done , liver and kidney function was also monitored .
METHODS	The quality of life was documented before operation , and one and twelve months after operation .
RESULTS	No significant differences were found among these three groups in the pH value of lower part of esophagus , the blood regular test results and the functional parameters of kidney and liver before and after operation ( all P > 0.05 ) .
RESULTS	Symptoms of reflux esophagitis was reported in 1 ( 2.4 % ) patients in the jejunal interposition group , 10 ( 24.4 % ) in esophageal with the posterial of residual-stomach group , and 7 ( 17.1 % ) in the Roux-en-Y esophagojejunostomy group ( P = 0.017 ) .
RESULTS	There was 1 ( 2.4 % ) , 10 ( 17.1 % ) , and 8 ( 19.5 % ) patients presented reflux of barium meal in these three groups , respectively ( P = 0.046 ) .
RESULTS	There were no statistically significant difference in PH at the distal esophagus ( 6.90.2 vs. 6.80.1 vs. 6.90.1 , P = 0.196 ) .
RESULTS	The quality of life was significantly improved one year after surgery in terms of general status , physical function , emotional function , fatigue , nausea/vomiting , pain , constipation , and diarrhea ( all P < 0.05 ) , with the jejunal interposition superior than the other two methods .
CONCLUSIONS	Three methods of digestive tract reconstruction in radical gastrectomy of gastric cancer patients can improve the health status and the quality of life in gastric cancer patients .
CONCLUSIONS	Radical proximal gastrectomy and jejunal interposition is the preferred method .

###24772726
OBJECTIVE	To evaluate the effectiveness , safety and tolerability of a probiotic formulation containing Lactobacillus acidophilus LA-5 and Bifidobacterium BB-12 in the prevention of antibiotic associated diarrhoea ( AAD ) .
METHODS	A double-blind randomised placebo controlled multicentric trial was conducted in adults who were prescribed a seven-day course of oral antibiotic ( either cefadroxil or amoxycillin ) for a documented indication .
METHODS	The effectiveness of a 14-day therapy ( concomitant with antibiotic course and seven days thereafter ) of the probiotic formulation in preventing AAD was evaluated .
METHODS	Safety profile was assessed by monitoring of all treatment emergent adverse events and tolerability on a global well being scale .
RESULTS	The incidence of AAD in the probiotic group was 10.8 % compared to 15.6 % in the placebo group , the difference being statistically non-significant ( p = 0.19 ) .
RESULTS	The relative risk for AAD was 0.7 with the 95 % CI being 0.4 to 1.2 .
RESULTS	The diarrhoea duration in the probiotic group was two days with an interquartile range of 1 - 3 days and was significantly less ( p = 0.01 ) than the placebo group which was four days with an interquartile range of 3 - 5.5 days .
RESULTS	Subgroup analysis of subjects with AAD showed that the incidence of severe diarrhoea ( watery stools ) was 96 % in the placebo group ( 25 out of 26 ) compared to 31.6 % ( 6 out of 19 ) in the probiotic group and this difference was significant statistically ( p < 0.001 ) .
RESULTS	Four mild , non-serious , adverse events were detected ( 2.0 % ) in the probiotic group but there were none in the placebo group .
CONCLUSIONS	This randomised controlled trial shows that prophylactic administration of the probiotic formulation containing Lactobacillus acidophilus LA-5 and Bifidobacterium BB-12 , did not effectively lower the incidence of AAD in adults .
CONCLUSIONS	However , compared to placebo the duration of diarrhoea in the probiotic group was significantly reduced .
CONCLUSIONS	Its tolerability and safety profile were good .

###25101576
OBJECTIVE	To compare clinical and hemodynamic outcome in patients undergoing treatment of common femoral artery ( CFA ) atherosclerotic lesions by bioabsorbable stent implantation ( BASI group ) or by common femoral artery endarterectomy ( CFE group ) .
METHODS	A randomized , controlled , single-center , open-label trial was initiated to compare outcomes of BASI or CFE in patients with chronic atherosclerotic occlusive lesions in the CFA .
METHODS	From May 2011 to April 2013 , 116 consecutive patients were recruited ; after excluding 36 patients , 80 patients ( 52 men ; mean age 72.29.6 years ) were enrolled 1:1 and are the subject of this intention-to-treat interim analysis ( 40 patients in each group ) .
METHODS	The primary endpoint was surgical site infections ; secondary outcome measures were technical success , hemodynamic improvement , clinical improvement , patency , limb salvage , and survival .
RESULTS	There was no statistically significant difference between both groups regarding demographic data , cardiovascular risk factors , or CFA occlusions .
RESULTS	The CFE patients presented with 7 surgical site infections ( all minor ) vs. none in the BASI group ( p = 0.002 ) and a longer mean postoperative hospital stay of 7 vs. 2 days for BASI patients ( p < 0.001 ) .
RESULTS	Technical success rates were 97.5 % and 100 % for the BASI and CFE groups , respectively .
RESULTS	Postoperative ankle-brachial index means were comparable ( p = 0.38 ) .
RESULTS	The 30-day primary patency rates were 92.5 % and 100 % for the BASI and CFE groups , respectively ( p = 0.038 ) .
RESULTS	There were 6 reconstruction failures in CFE patients vs. none in the BASI group ( p = 0.02 ) ; 5 failures involved initial CFA occlusions .
RESULTS	At 1 year , the primary and secondary patency rates were 80 % vs. 100 % ( p = 0.007 ) and 84 % vs. 100 % ( p = 0.01 ) for BASI and CFE patients , respectively .
RESULTS	Limb salvage was equivalent , and survival rates were 88 % and 90 % for BASI vs. CFE patients ( p = 0.51 ) at 1 year .
CONCLUSIONS	This interim analysis suggests that BASI is not an option for CFA occlusion and is only a limited option for CFA stenosis .
CONCLUSIONS	Clinical and hemodynamic results are comparable for BASI and CFE .
CONCLUSIONS	An increased rate of redo procedures in the BASI patients outweighs lower surgical site infection rates compared to CFE .
CONCLUSIONS	Short-term patency rates are significantly worse in patients undergoing CFA stenting with BASI .

###24794512
OBJECTIVE	To assess the interest of specifically targeting Brodmann Areas ( BA ) 9 or 46 for rTMS treatment of depression .
METHODS	Patients with Treatment-Resistant Depression were randomly assigned to two treatment groups to receive either rTMS on BA 9 or on BA 46 .
METHODS	Each patient underwent 10 sessions of 1Hz-rTMS for 2weeks .
METHODS	The Hamilton and Montgomery-Asberg Depression Rating Scales ( HDRS , MADRS ) were used under blind conditions to assess the therapeutic response ( 50 % improvement ) .
METHODS	A Wilcoxon signed-rank test was used to compare the depression rating scales scores obtained before and after the 10 rTMS sessions for each of the two groups .
METHODS	The therapeutic results in the two groups were compared using the Mann-Whitney-Wilcoxon test .
METHODS	We also reported the effect sizes using Hedges 's g.
RESULTS	Fifteen patients were included .
RESULTS	Stimulation of both BA 9 ( n = 7 ) and BA 46 ( n = 8 ) led to similar therapeutic responses in the two groups ( with moderate effect size ) , such as the mean decrease in HDRS ( BA 9 : p = 0.015 ; BA 46 : p = 0.010 ) and MADRS ( BA 9 : p = 0.042 ; BA 46 : p = 0.038 ) scores .
CONCLUSIONS	Our results do not come out in favor of one or the other BA .
CONCLUSIONS	Stimulation of BA 9 and BA 46 appears to be equally effective in the treatment of depression .

###24666552
BACKGROUND	Gastric cancer is a major contributor to cancer deaths in Zambia but , as elsewhere , no preventive strategies have been identified .
BACKGROUND	We set out to investigate the possibility of reducing gastric atrophy , a premalignant lesion , using micronutrient-antioxidant supplementation .
METHODS	We analysed 215 archival samples from a randomised controlled trial of micronutrient-antioxidant supplementation carried out from 2003 to 2006 .
METHODS	Participants were randomised to receive either the supplement or placebo and had been taking the allocated intervention for a mean of 18 ( range 14-27 ) months when the samples used in this study were taken .
METHODS	We used low pepsinogen 1 to 2 ( PEP1 :2 ) ratio as a surrogate marker of gastric atrophy .
METHODS	A PEP 1:2 ratio of less than three was considered low .
METHODS	HIV serology , age , nutritional status , smoking , alcohol intake and gastric pH were also analysed .
METHODS	Ethical approval was obtained from the University of Zambia Biomedical Research Ethics Committee ( 011-04-12 ) .
METHODS	The randomized trial was registered ( ISRCTN31173864 ) .
RESULTS	The overall prevalence of low PEP 1:2 ratio was 15/215 ( 7 % ) and it did not differ between the placebo ( 8/103 , 7.8 % ) and micronutrient groups ( 7/112 , 6.3 % ; HR 1.24 ; 95 % CI 0.47-3 .3 ; P = 0.79 ) .
RESULTS	The presence of low PEP 1:2 ratio was not influenced by HIV infection ( HR 1.07 ; 95 % CI 0.37-3 .2 ; P = 0.89 ) or nutritional status but it inversely correlated with gastric pH ( Spearman 's rho = -0.34 ; P = 0.0001 ) .
RESULTS	Age above 40 years was associated with atrophy , but neither alcohol nor smoking had any influence .
CONCLUSIONS	Short term micronutrient supplementation does not have any impact on PEP 1:2 ratio , a serological marker of gastric atrophy .
CONCLUSIONS	PEP 1:2 ratio inversely correlates with gastric pH.

###24861133
OBJECTIVE	Patients with acute coronary syndrome and certain co-morbidities may receive ticagrelor , a reversibly binding P2Y ( 12 ) receptor antagonist , and cyclosporine , a commonly used immunosuppressant drug .
OBJECTIVE	This study assessed the potential pharmacokinetic drug-drug interaction between ticagrelor and cyclosporine .
METHODS	In this single-centre , open-label , three-treatment , three-period crossover study ( NCT01504906 ) , healthy volunteers ( n = 26 ) randomly received each of three treatments : cyclosporine ( 600 mg single oral dose ) plus ticagrelor ( 180 mg single oral dose ) ; cyclosporine alone ; ticagrelor alone .
METHODS	Treatments were separated by a washout period of 14 days .
METHODS	Plasma concentrations of ticagrelor and its active metabolite ( AR-C124910XX ) and blood concentrations of cyclosporine were analyzed , and pharmacokinetic parameters were calculated .
METHODS	Safety and tolerability were assessed .
RESULTS	Compared with ticagrelor alone , the geometric least squares mean ( LSM ) ratio ( 90 % confidence interval [ CI ] ) for the ticagrelor area under the plasma concentration-time curve from time zero to infinity ( AUC ( ) ) was 2.83 ( 2.63-3 .06 ) , and the maximum plasma concentration ( C ( max ) ) was 2.30 ( 2.06-2 .58 ) , in the presence of cyclosporine .
RESULTS	Co-administration of cyclosporine with ticagrelor significantly increased AR-C124910XX AUC ( ) ( 1.33 [ 1.23-1 .42 ] ) and decreased C ( max ) ( 0.85 [ 0.76-0 .94 ] ) .
RESULTS	Ticagrelor had no effect on cyclosporine pharmacokinetic parameters , as the 90 % CIs of the LSM ratios were all within the 0.80-1 .25 no-effect range .
RESULTS	Co-administration of ticagrelor and cyclosporine was generally well tolerated .
CONCLUSIONS	Co-administration of cyclosporine with ticagrelor increased exposure to ticagrelor and its active metabolite and had no effect on cyclosporine pharmacokinetic parameters .
CONCLUSIONS	The magnitude of cyclosporine 's effect on ticagrelor pharmacokinetics does not warrant dose adjustment of ticagrelor .

###24603733
BACKGROUND	Human T cell lymphotropic virus type I-associated myelopathy/tropical spastic paraparesis ( HAM/TSP ) can impact the independence and motricity of patients .
BACKGROUND	The aims of this study were to estimate the effects of physiotherapy on the functionality of patients with HAM/TSP during the stable phase of the disease using proprioceptive neuromuscular facilitation ( PNF ) and to compare two methods of treatment delivery .
METHODS	Fourteen patients with human T cell lymphotropic virus type I ( HTLV-I ) were randomly allocated into two groups .
METHODS	In group I ( seven patients ) , PNF was applied by the therapist , facilitating the functional activities of rolling , sitting and standing , walking and climbing and descending stairs .
METHODS	In group II ( seven patients ) , PNF was self-administered using an elastic tube , and the same activities were facilitated .
METHODS	Experiments were conducted for 1h twice per week for 12 weeks .
METHODS	Low-back pain , a modified Ashworth scale , the functional independence measure ( FIM ) and the timed up and go test ( TUG ) were assessed before and after the interventions .
RESULTS	In the within-group evaluation , low-back pain was significantly reduced in both groups , the FIM improved in group II , and the results of the TUG improved in group I.
RESULTS	In the inter-group analysis , only the tone was lower in group II than in group I.
CONCLUSIONS	Both PNF protocols were effective in treating patients with HAM/TSP .

###25556490
OBJECTIVE	To observe treatment effects and safety of fluvoxamine combined with oxycodone prolonged-release tablets in treating patients with moderate to severe cancer pain .
METHODS	Patients confirmed pathologically with cancer and complicated with moderate to severe pain , were divided into control and experimental groups .
METHODS	Oxycodone prolonged-release tablets , with or without fluvoxamine , were administrated to all study patients until pain relief .
METHODS	Degree of pain relief , dose of oxycodone prolonged-release tablets , side effects and quality of life were compared before and after treatment .
RESULTS	In total , 120 patients were recruited .
RESULTS	No statistically significant difference was detected regarding age , gender , types of cancer , KPS between two groups of patients ( P > 0.05 ) .
RESULTS	Baseline pain score of patients with moderate pain in treatment and control group was 4.90.8 and 5.10.8 , respectively ; and decreased to 1.81.1 and 1.21.1 after treatment , respectively .
RESULTS	Pain intensity was significantly reduced in the treatment group ( P = 0.028 ) .
RESULTS	Average daily consumption of oxycodone prolonged - release tablets was ( 54.019.6 ) mg and ( 44.7 18.7 ) mg respectively , which is lower in treatment grpup than in control group , but the difference was not statistically significant ( P = 0.065 ) .
RESULTS	Baseline pain score of patients with severe pain in treatment and control groups were 8.31.1 and 8.31.1 , respectively ; and pain intensity after treatment decreased to 2.91.0 and 2.31.0 .
RESULTS	Pain intensity was significantly reduced in the treatment group , with statistical significance ( P = 0.026 ) .
RESULTS	Average daily consumption of oxycodone prolonged-release tablets was ( 132.042.2 ) mg and ( 110.733.9 ) mg , respectively , which is lower in treatment group than in control group , and the difference was statistically significant ( P = 0.035 ) .
RESULTS	In terms of quality of life , patients in treatment group had better performance status , daily activity , mood , and sleep than that in control group ( P < 0.05 ) .
RESULTS	Patients in two groups had similar side effects , eg. , constipation , nausea/vomiting , lethargy , dizziness , itchy skin , dysuria , and ataxia .
RESULTS	Lower incidence of nausea/vomiting , lethargy , was obtained from patients in treatment than in control group , while significant low constipation was observed in treatment than in control group ( 35.0 % vs 49.2 % , P = 0.026 ) .
CONCLUSIONS	Fluvoxamine combined with oxycodone prolonged-release tablets could be more effective in treating patients with cancer pain , and could reduce the dosage of oxycodone prolonged-release tablets and thus be associated with lower side effects , and improved quality of life .

###24619062
BACKGROUND	We hypothesized that the optimization of renal haemodynamics by maintaining a high level of mean arterial blood pressure ( MAP ) during cardiopulmonary bypass ( CPB ) could reduce the rate of acute kidney injury ( AKI ) in high-risk patients .
METHODS	In this randomized , controlled study , we enrolled 300 patients scheduled for elective cardiac surgery under cardiopulmonary bypass .
METHODS	All had known risk factors of AKI : serum creatinine clearance between 30 and 60 ml/min for 1.73 m ( 2 ) or two factors among the following : age > 60 years , diabetes mellitus , diffuse atherosclerosis .
METHODS	After a standardized fluid loading , the MAP was maintained between 75-85 mmHg during CPB with norepinephrine ( High Pressure , n = 147 ) versus 50-60 mmHg in the Control ( n = 145 ) .
METHODS	AKI was defined by a 30 % increased of serum creatinine ( sCr ) .
METHODS	We further tested others definitions for AKI : RIFLE classification , 50 % rise of sCr and the need for haemodialysis .
RESULTS	The pressure endpoints were achieved in both the High Pressure ( 79 6 mmHg ) and the Control groups ( 60 6 mmHg ; p < 0.001 ) .
RESULTS	The rate of AKI did not differ by group ( 17 % vs. 17 % ; p = 1 ) , whatever the criteria used for AKI .
RESULTS	The length of stay in hospital ( 9.5 days [ 7.9-11 .2 ] vs. 8.2 [ 7.1-9 .4 ] ) and the rate of death at day 28 ( 2.1 % vs. 3.4 % ) and at six months ( 3.4 % vs. 4.8 % ) did not differ between the groups .
CONCLUSIONS	Maintaining a high level of MAP ( on average ) during normothermic CPB does not reduce the risk of postoperative AKI .
CONCLUSIONS	It does not alter the length of hospital stay or the mortality rate .

###25446217
BACKGROUND	The composition of fatty acids in a diet may differentially affect metabolism , thus playing a role in the development of obesity .
BACKGROUND	Our purpose was to study the effects of three high-fat ( HF ) meals with different dietary fatty acid compositions on the thermic effect of meal ( TEM ) and substrate oxidation in obese premenopausal women .
METHODS	16 healthy obese women , aged 18-39 years , participated in a single-blinded randomized cross-over study , in which they consumed isocaloric HF meals ( 70 % of energy from fat ) rich in either saturated fat ( SFA ) , monounsaturated fat ( MUFA ) or polyunsaturated fat ( PUFA ) .
METHODS	Indirect calorimetry was used to measure respiratory gases for a 5-hour postprandial period .
METHODS	Data collected was used to determine respiratory exchange ratio ( RER ) for assessing substrate oxidation , and energy expenditure for the determination of TEM .
RESULTS	There was a significant time effect on both substrate oxidation and TEM ( p < 0.05 ) .
RESULTS	With and without using RMR as a covariate , there were no significant differences in TEM between test meals ( TEM of 10.80.8 vs 11.01.0 kcal 5 h for high-MUFA vs. high-SFA meals , respectively , p = 0.06 ) .
RESULTS	No treatment difference was found for postprandial substrate utilization ( 4.90.4 , 4.90.3 and 4.60.4 g of fat oxidation following SFA , MUFA , and PUFA-rich HF meals , respectively ; 13.20.9 , 13.30.5 and 13.90.6 g of carbohydrate oxidation following SFA , MUFA , and PUFA-rich HF meals , respectively ) .
CONCLUSIONS	In premenopausal obese women , HF meals rich in either MUFAs , PUFAs , or SFAs did not differentially affect TEM or postprandial substrate oxidation .

###24648723
BACKGROUND	Selective serotonin reuptake inhibitors improve cognition in patients with stroke and increase the expression of brain-derived neurotrophic factor ( BDNF ) in the rat hippocampus .
BACKGROUND	However , the effects of selective serotonin reuptake inhibitors on cognition and serum BDNF levels in patients with vascular dementia are largely unknown .
BACKGROUND	We performed an open-label study to investigate the effects of fluoxetine , a selective serotonin reuptake inhibitor , on cognition and serum BDNF levels in patients with vascular dementia .
METHODS	Fifty patients with vascular dementia were randomly allocated to receive fluoxetine ( 20 mg/day ; n = 25 ) or no fluoxetine ( control group ; n = 25 ) for 12 weeks .
METHODS	Both groups received secondary prevention of stroke .
METHODS	Serum BDNF level , Mini-Mental State Examination ( MMSE ) score , Ten-Point Clock Drawing score , and Digit Span Test and Verbal Fluency Test scores were measured at baseline and at week 12 in the both groups .
RESULTS	The baseline serum BDNF level correlated significantly with the MMSE score .
RESULTS	MMSE score , Ten-Point Clock Drawing score , and serum BDNF level increased significantly in the fluoxetine group but not in the control group .
RESULTS	The increase in serum BDNF level correlated with the increase in MMSE score in the fluoxetine group .
CONCLUSIONS	Fluoxetine may potentially improve cognition in patients with vascular dementia and requires further investigation .
CONCLUSIONS	BDNF may play an important role in cognitive recovery .

###24953836
OBJECTIVE	Bile acid malabsorption ( BAM ) - associated diarrhea is an important clinical issue in patients with Crohn 's disease ( CD ) .
OBJECTIVE	We analyzed the efficacy and safety of the bile acid sequestrant colesevelam for treatment of BAM-associated diarrhea in CD patients in a randomized , double-blind , placebo-controlled study .
METHODS	The primary endpoint was the proportion of patients with > 30 % reduction of liquid stools/day from baseline to termination visit at week 4 .
METHODS	Secondary endpoints were reduction of the number of liquid stools/day , improvement of stool consistency and quality of life .
RESULTS	26 patients were analyzed in the intention-to-treat ( ITT ) analysis .
RESULTS	The primary endpoint was reached by 10 patients ( 69.7 % ) in the colesevelam group compared to 3 patients ( 27.3 % ) in the placebo group ( risk difference RD = .394 , 95 % CI :[ -0.012 ; 0.706 ] ; P = .0566 ) .
RESULTS	In the per-protocol analysis ( n = 22 ) , the risk difference was statistically significant ( RD = .470 , 95 % CI : [ 0.018 ; 0.788 ] , P ( H0 : RD = 0 ) = 0.0364 ; 95 % CI : [ 1.3 ; 54.7 ] ) .
RESULTS	Regarding secondary endpoints , in the ITT population colesevelam-treated patients had a significant reduction of liquid stools/day at week 4 ( median 5.0 to 2.0 ; P = 0.01 ) , while patients treated with placebo had no significant reduction ( median 4.0 to 3.0 ; P = 0.42 ) .
RESULTS	Significantly more patients in the colesevelam group had improvement of stool consistency of at least one level in the Bristol stool chart , as compared to the placebo group ( P = 0.003 ) .
CONCLUSIONS	We found significant differences in favor for colesevelam treatment compared to placebo treatment for CD patients with BAM regarding the reduction of the number of liquid stools/day and stool consistency .
CONCLUSIONS	ClinicalTrials.gov number : NCT01203254 .

###25932833
OBJECTIVE	To estimate whether women who underwent mnemonic counseling had better recall of fecal incontinence therapies at 2 months and if mnemonic counseling resulted in greater satisfaction with physician counseling and improvement in quality of life when compared with a group who underwent standard counseling .
METHODS	Counseling-naive women with fecal incontinence were recruited from an academic urogynecology clinic .
METHODS	Women underwent physical examinations , completed the Quality of the Physician-Patient Interaction , recorded fecal incontinence treatment options they recalled , and completed the Fecal Incontinence Severity Index and Manchester Health Questionnaire immediately after counseling and again at 2 months .
RESULTS	Ninety women consented to participate , were randomized , and completed baseline questionnaires .
RESULTS	At baseline , women did not differ in age , ethnicity , education , Fecal Incontinence Severity Index , or Manchester Health Questionnaire scores .
RESULTS	After counseling , the mnemonic group reported higher satisfaction on Quality of the Physician-Patient Interaction ( 66.46.5 compared with 62.210.7 , P = .03 ) .
RESULTS	Ninety percent ( 81/90 ) of women followed up at 2 months .
RESULTS	Our primary endpoint , 2-month recall of fecal incontinence treatments , was not different between groups ( 2.31.6 mnemonic counseling compared with 1.81.0 standard counseling ; P = .08 ) .
RESULTS	Secondary endpoints for the mnemonic group reported greater improvement on total Manchester Health Questionnaire ( P = .02 ) , emotional ( P = .03 ) , sleep ( 0.045 ) , role limitations ( P < .01 ) , and physical limitations ( P = .04 ) when compared with the standard group .
CONCLUSIONS	Fecal incontinence counseling with a mnemonic aid did not improve recall at 2 months but improved patient satisfaction and quality of life at 2 months .

###24910271
BACKGROUND	Hyaluronic acid ( HA ) fillers are FDA approved for improving the appearance of the nasolabial folds .
BACKGROUND	Previous reports on the use of HA for this treatment have focused on injections directly into the location of the desired correction .
BACKGROUND	To our knowledge , a study has not been done evaluating the efficacy of injecting a low volume of HA into the adjacent area of volume loss to correct both volume loss and adjacent lines .
OBJECTIVE	The objective of this study was to compare the effectiveness and safety of three HA injection protocols including deep dermal cheek injection , mid - to deep dermal local nasolabial fold injection , and both injections for the correction of nasolabial folds .
METHODS	This was a split-face , randomized study evaluating the use of three injection techniques - ( i ) deep bolus injection into the mid - to lateral cheek , ( ii ) local mid - to deep dermal injection into the nasolabial fold , and ( iii ) both deep injection into the mid - to lateral cheek and local mid - to deep dermal injection into the nasolabial fold - for the treatment of moderate to severe nasolabial folds .
METHODS	Wrinkle severity and Global Aesthetic Improvement Scales were measured before and 4-6weeks after treatment as assessed by a blinded investigator .
RESULTS	Patient and physician observations showed improvement both globally and in wrinkle severity score with each technique used with no statistical difference between techniques .
RESULTS	Patients showed a slight preference for injection to both the mid - to lateral cheek and nasolabial fold , which was associated with the greatest amount of filler product administered .
RESULTS	No serious adverse events were reported .
CONCLUSIONS	Injection of a dermal filler , at low volumes , into either the nasolabial fold or mid - to lateral cheek results in similar improvement to the correction of the nasolabial folds .

###25218139
OBJECTIVE	To determine whether vibratory stimulation would decrease pain experienced by patients during corticosteroid injection for trigger finger .
METHODS	A total of 90 trigger finger injections were randomized to 1 of 3 cohorts .
METHODS	With the injection , patients received no vibration ( control group ) , ultrasound vibration ( sham control group ) , or vibration ( experimental group ) .
METHODS	We used a commercial handheld massaging device to provide a vibratory stimulus for the experimental group .
METHODS	We obtained visual analog scale ( VAS ) pain scores before and after injection to assess anticipated pain and actual pain experienced .
RESULTS	Anticipated pain and actual pain did not differ significantly among groups .
RESULTS	Anticipated VAS pain scores were 45 , 48 , and 50 and actual VAS pain scores were 56 , 56 , and 63 for the vibration , control , and sham control groups , respectively .
RESULTS	When normalized using anchoring VAS pain scores for `` stubbing a toe '' or `` paper cut , '' no between-group differences remained in injection pain scores .
CONCLUSIONS	Concomitant vibratory stimulation does not reduce pain experienced during corticosteroid injections for trigger finger .
METHODS	Therapeutic I.

###25012399
BACKGROUND	Depression is a leading cause of disability worldwide and , although efficacious treatments are available , their efficacy is suboptimal and recurrence of symptoms is common .
BACKGROUND	Effective preventive strategies could reduce disability and the long term social and health complications associated with the disorder , but current options are limited .
BACKGROUND	Cognitive bias modification ( CBM ) is a novel , simple , and safe intervention that addresses attentional and interpretive biases associated with anxiety , dysphoria , and depression .
BACKGROUND	The primary aim of this trial is to determine if CBM decreases the one-year onset of a major depressive episode among adults with subsyndromal depression .
METHODS	This randomised controlled trial will recruit 532 adults with subsyndromal symptoms of depression living in the Australian community ( parallel design , 1:1 allocation ratio ) .
METHODS	Participants will be free of clinically significant symptoms of depression and of psychotic disorders , sensory and cognitive impairment , and risky alcohol use .
METHODS	The CBM intervention will target attentional and interpretive biases associated with depressive symptoms .
METHODS	The sessions will be delivered via the internet over a period of 52 weeks .
METHODS	The primary outcome of interest is the onset of a major depressive episode according the DSM-IV-TR criteria over a 12-month period .
METHODS	Secondary outcomes of interest include change in the severity of depressive symptoms as measured by the Patient Health Questionnaire ( PHQ-9 ) , use of antidepressants or benzodiazepines , and changes in attention and interpretive biases .
METHODS	The assessment of outcomes will take place 3 , 6 , 9 , and 12 months after randomisation and will occur via the internet .
CONCLUSIONS	We propose to test the efficacy of an innovative intervention that is well grounded in theory and for which increasing empirical evidence for an effect on mood is available .
CONCLUSIONS	The intervention is simple , inexpensive , easy to access , and could be easily rolled out into practice if our findings confirm a role for CBM in the prevention of depression .
BACKGROUND	Australian and New Zealand Clinical Trials Registry ACTRN12613001334796 .
BACKGROUND	Date : 5th December 2013 .

###26117944
OBJECTIVE	To observe the clinical effectiveness of Qilin Pills combined with sertraline in the treatment of secondary non-consolidated kidney qi premature ejaculation ( PE ) .
METHODS	A total of 120 patients with secondary non-consolidated kidney qi PE were randomly assigned to groups A ( aged [ 35.5 5.4 ] yr ) , B ( aged [ 36.2 5.7 ] yr ) , and C ( aged [ 35.2 5.3 ] yr ) in the ratio of 1:1:1 to receive Qilin Pills ( once 6 g , bid ) , sertraline ( once 50 mg , qd ) , and Qilin Pills plus sertraline , respectively , all for 4 weeks .
METHODS	The intravaginal ejaculatory latency time ( IELT ) and PE diagnostic tool ( PEDT ) scores were obtained before and after medication and at 1 month after drug withdrawal , and comparative analyses were made among the three groups of patients .
RESULTS	The IELT was dramatically prolonged in groups A , B , and C after treatment ( [ 3.23 1.84 ] , [ 3.87 2.43 ] , and [ 5.92 3.11 ] min ) and at 1 month after drug withdrawal ( [ 1.85 1.27 ] , [ 1.52 1.06 ] , and [ 4.26 1.88 ] min ) as compared with the baseline ( [ 0.88 0.45 ] , [ 0.84 0.47 ] , and [ 0.85 0.50 ] min ) ( P < 0.01 ) , even longer in group C than in A and B ( P < 0.01 ) .
RESULTS	The PEDT scores of the three groups were 5.1 1.8 , 4.9 1.7 , and 3.8 1.2 after treatment and 8.2 2.4 , 8.1 2.4 , and 6.5 2.1 at 1 month after drug withdrawal , significantly improved in comparison with 13.2 3.2 , 12.8 3.1 , and 13.1 3.4 before treatment ( P < 0.01 ) , even more significantly in group C than in A and B ( P < 0.01 ) .
CONCLUSIONS	Qilin Pills combined with sertraline has a definite efficacy in the treatment of secondary non-consolidated kidney qi PE and therefore deserves wide clinical application .

###25356570
OBJECTIVE	Tinnitus affects more than 40 million people in the Unites States , and cognitive difficulties are among the most commonly associated symptoms .
OBJECTIVE	To test the feasibility and preliminarily the effectiveness of using a putative neuroplasticity-enhancing drug , D-cycloserine , to facilitate a computer-assisted CT program for improving tinnitus bother and related cognitive difficulties .
METHODS	Double-blind , randomized clinical trial at an outpatient academic medical center of 34 participants aged 35 to 65 years with subjective , unilateral or bilateral , nonpulsatile tinnitus of at least 6 months ' duration .
METHODS	Five weeks of twice-weekly computer-based CT with either 250 mg D-cycloserine or placebo orally prior to computer CT sessions .
METHODS	Difference in the change in Tinnitus Functional Index ( TFI ) score between the 2 groups .
RESULTS	After excluding 1 participant lost to follow-up , 1 who withdrew , 1 who did not complete 90 % of sessions , and 1 outlier , 30 participants were included in the analysis .
RESULTS	The D-cycloserine plus CT group showed a significant improvement in median TFI score ( -5.8 [ 95 % CI , -9.4 to -1.1 ] ) and self-reported cognitive deficits ( -4.5 [ 95 % CI , -11.5 to -1.0 ] ) , but the placebo group did not ( -1.0 [ 95 % CI , -11.7 to 4.9 ] and -2.0 [ 95 % CI , -5.1 to 2.0 ] , respectively ) .
RESULTS	After controlling for age and duration of tinnitus , there was no significant difference in TFI score change between the 2 groups ( P = .41 ) .
RESULTS	After confounders were controlled for , the D-cycloserine group demonstrated a significantly greater improvement in self-reported cognitive deficits as compared with the placebo group ( P = .03 ) .
RESULTS	No serious adverse events were reported .
CONCLUSIONS	Use of a computer-based CT program with a putative neuroplasticity-sensitizing drug , D-cycloserine , was feasible and well tolerated .
CONCLUSIONS	With the limited sample size , the adjuvant use of D-cycloserine was no more effective than placebo at improving tinnitus bother .
CONCLUSIONS	The finding that D-cycloserine use was more effective than placebo at improving self-reported cognitive difficulties could be important given the high rate of concern for cognitive deficits in patients with tinnitus .
CONCLUSIONS	D-cycloserine and other putative neuroplasticity-facilitating agents could be investigated in the future as a strategy to enhance neuroplasticity-based tinnitus treatments .
BACKGROUND	clinicaltrials.gov Identifier : NCT01550796 .

###24879167
BACKGROUND	Tracheal intubation results in an alteration of the laryngeal mucosa which can lead to undesirable effects at emergence from anaesthesia .
BACKGROUND	Local anesthetics , when administered topically , may represent an interesting alternative to reduce these side effects .
OBJECTIVE	In this trial , we aimed to evaluate the effect of lidocaine in preventing tracheal intubation related side effects at emergence from anaesthesia , when instilled onto the glottis before intubation or used to inflate the endotracheal tube cuff .
METHODS	Eighty patients scheduled to elective surgery of less than 120 minutes under general anaesthesia were enrolled in this prospective , randomized , controlled , double blind study .
METHODS	As they receive instillation of 2 % lidocaine or saline onto the glottis before intubation , and as they have their endotracheal tube cuff filled with 2 % lidocaine or saline , the patients were randomized in four groups .
METHODS	S-S ( Saline instillation and saline in the cuff ) ; S-Lido ( saline instillation and lidocaine in the cuff ) ; Lido-S ( lidocaine instillation and saline in the cuff ) ; Lido-Lido ( lidocaine instillation and lidocaine in the cuff ) .
METHODS	The primary outcome was the incidence of coughing before extubation .
METHODS	The secondary outcomes were sore throat scores at H1 and H24 postoperatively and incidence of dysphagia , dysphonia and laryngeal dyspnea during the first 24 hours .
RESULTS	Coughing occurred in 80 % , 70 % , 30 % and 20 % of patients in S-S , S-Lido , Lido-S and Lido-Lido groups respectively .
RESULTS	When compared to S-S group , the incidence of coughing was significantly reduced in Lido-S and Lido-Lido groups but not in S-Lido group ( p1 = 0.003 ; p2 = 0.0003 ; p3 = 0.7 respectively ) .
RESULTS	Sore throat scores at H1 and H24 were significantly lower in Lido-S and Lido-Lido groups ( p1 = 0.00002 and p2 = 0.01 ) .
RESULTS	There was no significant difference between groups regarding the incidence of dysphagia , dysphonia and laryngeal dyspnea .
CONCLUSIONS	When instilled onto the glottis before intubation , lidocaine reduced both the incidence of coughing and the severity of postoperative sore throat in surgery of less than 120 minutes .
CONCLUSIONS	Intracuff lidocaine was not effective to reduce neither coughing nor sore throat severity .

###24298764
OBJECTIVE	To verify the effect of bloodletting therapy at Jing-well points and semen coicis on patients with traumatic cerebral infarction .
METHODS	Ninety patients were randomized into a bloodletting therapy at Jing-well points group ( bloodletting group ) , a semen coicis group and a comprehensive therapy group , 30 cases in each one .
METHODS	The conventional basic medication was applied in all of the three groups .
METHODS	In the bloodletting group , the bloodletting therapy was done at twelve Jing-well points with three-edged needle , 3 drops of blood required at each one , three times a day .
METHODS	In the semen coicis group , the semen coicis preparation was applied via nasal feeding or oral administration , 90 g each day , three times a day .
METHODS	In the comprehensive therapy group , the bloodletting therapy at twelve Jing-well points and semen coicis preparation were used in combination and the methods were same as the above two groups .
METHODS	After 4 weeks of treatment , the efficacy was assessed with nerve function defectscale ( NDS ) .
METHODS	Fugl-Meyer scale of the upper and lower limb function was used to evaluate the motor function of the affected limbs of the patients before and after treatment .
RESULTS	The scores of Fugl-Meyer scale of the upper and lower limb function were increased apparently after treatment in the patients of every group ( P < 0.01 , P < 0.05 ) .
RESULTS	The score increase was much more obvious in the bloodletting group and the comprehensive therapy group as compared with the semen coicis group ( all P < 0.01 ) .
RESULTS	The result in the comprehensive therapy group was superior to the bloodletting group ( all P < 0.05 ) .
RESULTS	The total effective rates of NDS in the comprehensive therapy group , bloodletting group and semen coicis group were 96.7 % ( 29/30 ) , 83.3 % ( 25/30 ) and 76.7 % ( 23/30 ) separately .
RESULTS	The result in the comprehensive therapy group was higher apparently than those in the bloodletting group and semen coicis group separately ( both P < 0.05 ) .
RESULTS	The result in the bloodletting group was better than that in the semen coicis group ( P < 0.05 ) .
CONCLUSIONS	The bloodletting therapy at Jing-well points and semen coicis alleviate apparently nerve function defect , improve the motor function of the affected limbs and achieve the better efficacy .

###24390800
OBJECTIVE	To evaluate the effect of radiofrequency surgery of the soft palate on daytime sleepiness in snoring men with mild or no sleep apnea .
METHODS	Randomized controlled trial .
METHODS	Thirty-five men were recruited from consecutive patients referred to the Ear , Nose , and Throat Clinic due to snoring and complaints of daytime sleepiness .
METHODS	The inclusion criteria were an apnea-hypopnea index ( AHI ) of15 , male gender , and age 18 to 65 years .
METHODS	Patients were randomized to either radiofrequency or sham surgery of the soft palate .
METHODS	All but one chose and received the option of three treatments .
METHODS	All patients participated in a follow-up , including an overnight sleep apnea recording and questionnaires 12 months after the last treatment .
METHODS	The primary outcome was daytime sleepiness measured with the Epworth Sleepiness Scale ( ESS ) and other questionnaires .
METHODS	Secondary outcomes were effects on the AHI and subjective snoring .
RESULTS	Thirty-two of 35 patients-19 of 20 patients in the radiofrequency surgery group and 13 of 15 patients in the sham surgery group-completed the study .
RESULTS	No differences between the two groups in relation to the ESS or AHI were found at follow-up .
CONCLUSIONS	Radiofrequency surgery of the soft palate has no effect on daytime sleepiness , snoring , or apnea frequency in snoring men with mild or no sleep apnea 1 year after surgery .
METHODS	1b .
METHODS	Laryngoscope 124:2422 -2426 , 2014 .

###24385202
OBJECTIVE	To determine the relationship between inflammation and glucocorticoid metabolism in vivo , in a clinical study of patients with inflammatory arthritis treated with anti-TNF therapy .
METHODS	Urine samples were collected from patients with rheumatoid arthritis ( RA ) and psoriatic arthritis ( PsA ) as part of a multicentre study assessing responses to infliximab and etanercept .
METHODS	Systemic measures of glucocorticoid metabolism were assessed by gas chromatography/mass spectrometry at weeks 0 ( baseline ) , 4 and 12 after anti-TNF therapy .
METHODS	Clinical data including DAS28 and C-reactive protein were also collected .
RESULTS	Systemic measures of 11-HSD1 activity in patients with inflammatory arthritis decreased significantly following anti-TNF therapy in patients with RA and PsA .
RESULTS	Additionally , the activity of the glucocorticoid inactivating enzyme 5-reductase appeared to increase significantly .
CONCLUSIONS	This study demonstrates , for the first time , that the increased 11-HSD1 activity seen in patients with inflammatory arthritis is mediated through TNF .
CONCLUSIONS	Furthermore , the changes in related glucocorticoid metabolising enzymes suggest that there is a coordinated change in glucocorticoid metabolism which promotes higher tissue glucocorticoid levels .

###24937307
OBJECTIVE	The use of the anthropometric indices of adiposity , especially body mass index and waist circumference in the prediction of diabetes mellitus has been widely explored .
OBJECTIVE	Recently , a new body composition index , the body adiposity index was proposed .
OBJECTIVE	The aim of this study was to compare the effectiveness of body mass index , waist circumference , and body adiposity index in the risk assessment for type 2 diabetes mellitus .
METHODS	A total of 1,572 individuals from the general population of Vitoria City , Brazil and 620 Amerindians from the Aracruz Indian Reserve , Brazil were randomly selected .
METHODS	BMI , waist circumference , and BAI were determined according to a standard protocol .
METHODS	Type 2 diabetes mellitus was diagnosed by the presence of fasting glucose 126 mg/dL or by the use of antidiabetic drugs .
RESULTS	The area under the curve was similar for all anthropometric indices tested in the Amerindian population , but with very different sensitivities or specificities .
RESULTS	In women from the general population , the area under the curve of waist circumference was significantly higher than that of the body adiposity index .
RESULTS	Regarding risk assessment for type 2 diabetes mellitus , the body adiposity index was a better risk predictor than body mass index and waist circumference in the Amerindian population and was the index with highest odds ratio for type 2 diabetes mellitus in men from the general population , while in women from the general population waist circumference was the best risk predictor .
CONCLUSIONS	Body adiposity index was the best risk predictor for type 2 diabetes mellitus in the Amerindian population and men from the general population .
CONCLUSIONS	Our data suggest that the body adiposity index is a useful tool for the risk assessment of type 2 diabetes mellitus in admixture populations .

###25643432
OBJECTIVE	This study tried to determine the efficacy and safety of low-dose intracoronary unfractionated heparin ( UFH ) in elective percutaneous coronary intervention ( PCI ) .
METHODS	Two-hundred patients who underwent elective PCI of an uncomplicated lesion were included into the study .
METHODS	The patients were assigned to either a control group ( 70-100 IU/kg intravenous UFH ) or a low-dose intracoronary UFH ( 1,000 IU intracoronary UFH ) group .
RESULTS	At 30 days , the primary end point ( composite of death , myocardial infarction , or urgent target vessel revascularization ) was similar in both groups [ intracoronary UFH group , 1.0 % ; control group , 2.0 % ; odds ratio ; 0.49 ( 95 % CI : 0.04 - 5.54 ) , P = 0.56 ] .
RESULTS	Post-procedural myocardial injury ( according to CK-MB , P = 0.91 ; according to Tn I , P = 0.81 ) and bleeding events ( based on TIMI criteria , P = 0.33 ; based on STEEPLE criteria , P = 0.20 ) were similar in the control and intracoronary groups .
RESULTS	The primary end point at 6 months was also similar between the two groups ( P = 0.33 ) .
RESULTS	Moreover , the health care cost at 30 days of follow-up was lower in the intracoronary group than in the control group ( 1,016 54 $ / patient vs 1,110 102 $ / patient , P < 0.001 ) .
CONCLUSIONS	This pilot study suggests that elective PCI could be safely performed with low-dose intracoronary UFH in the treatment of uncomplicated lesions and at a lower cost as compared to standard systemic anticoagulation.These results should be confirmed by further studies .

###25187580
BACKGROUND	Varus deformity increases the risk of progression of medial compartment knee osteoarthritis .
BACKGROUND	The aim of this study was to investigate the clinical and radiographic mid-term results of closing-wedge and opening-wedge high tibial osteotomy when used to treat this condition .
METHODS	From January 2001 to April 2004 , ninety-two patients were randomized to receive either a closing-wedge or an opening-wedge high tibial osteotomy .
METHODS	The clinical outcome and radiographic results were examined preoperatively ; at one year ; and , for the present study , at six years postoperatively .
METHODS	The outcomes that we reviewed included maintenance of the achieved correction , progression of osteoarthritis ( based on the Kellgren and Lawrence classification ) , severity of pain ( as assessed on a visual analog scale [ VAS ] ) , knee function ( as measured with the Hospital for Special Surgery [ HSS ] score and Knee injury and Osteoarthritis Outcome Score [ KOOS ] ) , walking distance , complications , and survival with conversion to a total knee arthroplasty as the end point .
METHODS	The results were analyzed on the basis of the intention-to-treat principle .
RESULTS	Six years postoperatively , the mean hip-knee-ankle ( HKA ) angle ( and standard deviation ) was 3.2 4.1 of valgus after a closing-wedge high tibial osteotomy and 1.3 5.0 of valgus after an opening-wedge high tibial osteotomy ( p = 0.343 ) .
RESULTS	In both groups , the six-year postoperative HKA angles did not differ from the respective one-year postoperative angles .
RESULTS	No difference in the severity of pain or in knee function was found between the two groups .
RESULTS	Four complications ( 9 % ) occurred in the closing-wedge group and seventeen ( 38 % ) , in the opening-wedge group .
RESULTS	Ten ( 22 % ) of the patients in the closing-wedge group and three ( 8 % ) in the opening-wedge group needed conversion to a total knee arthroplasty within the six-year period ( p = 0.05 ) .
RESULTS	The difference in the percentage of cases with conversion to total knee arthroplasty was 14 % ( 95 % confidence interval [ CI ] = 21.7 to 0.2 ) .
CONCLUSIONS	In the group of patients without conversion to a total knee arthroplasty , there was no difference between the high tibial closing-wedge and opening-wedge osteotomies in terms of clinical outcomes or radiographic alignment at six years postoperatively .
CONCLUSIONS	Opening-wedge osteotomy was associated with more complications , but closing-wedge osteotomy was associated with more early conversions to total knee arthroplasty .
METHODS	Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence .

###24855132
OBJECTIVE	Concussion is a common injury in sport .
OBJECTIVE	Most individuals recover in 7-10days but some have persistent symptoms .
OBJECTIVE	The objective of this study was to determine if a combination of vestibular rehabilitation and cervical spine physiotherapy decreased the time until medical clearance in individuals with prolonged postconcussion symptoms .
METHODS	This study was a randomised controlled trial .
METHODS	Consecutive patients with persistent symptoms of dizziness , neck pain and/or headaches following a sport-related concussion ( 12-30years , 18 male and 13 female ) were randomised to the control or intervention group .
METHODS	Both groups received weekly sessions with a physiotherapist for 8weeks or until the time of medical clearance .
METHODS	Both groups received postural education , range of motion exercises and cognitive and physical rest until asymptomatic followed by a protocol of graded exertion .
METHODS	The intervention group also received cervical spine and vestibular rehabilitation .
METHODS	The primary outcome of interest was medical clearance to return to sport , which was evaluated by a study sport medicine physician who was blinded to the treatment group .
RESULTS	In the treatment group , 73 % ( 11/15 ) of the participants were medically cleared within 8weeks of initiation of treatment , compared with 7 % ( 1/14 ) in the control group .
RESULTS	Using an intention to treat analysis , individuals in the treatment group were 3.91 ( 95 % CI 1.34 to 11.34 ) times more likely to be medically cleared by 8weeks .
CONCLUSIONS	A combination of cervical and vestibular physiotherapy decreased time to medical clearance to return to sport in youth and young adults with persistent symptoms of dizziness , neck pain and/or headaches following a sport-related concussion .
BACKGROUND	NCT01860755 .

###25034200
BACKGROUND	Mini percutaneous nephrolithotomy ( mini-PCNL ) and retrograde intrarenal surgery ( RIRS ) are well-established techniques with little morbidity .
BACKGROUND	The combined use of standard PCNL and the mini-PCNL or the RIRS technique was evaluated and compared to investigate their own role in the management of staghorn calculi in solitary kidney .
METHODS	23 patients received combined standard PCNL and mini-PCNL ( group 1 ) , and 22 patients received combined standard PCNL and RIRS ( group 2 ) .
METHODS	The treatment results and complications were evaluated and compared .
RESULTS	The mean operation time was 128.8 9.1 min in group 1 and 109.8 10.7 min in group 2 ( p < 0.001 ) .
RESULTS	The decrease in hemoglobin level in group 1 was significantly higher than that in group 2 ( 3.5 0.6 vs. 2.1 0.5 g/dl , p < 0.001 ) .
RESULTS	The final stone-free rate was significantly higher ( p = 0.038 ) in group 2 ( 90.9 % ) than in group 1 ( 65.2 % ) .
CONCLUSIONS	Combined standard PCNL and RIRS technique can extract the majority of staghorn calculi quickly by PCNL with EMS Lithoclast , and RIRS used simultaneously can reduce the need for multiple tracts and therefore reduce blood loss and potential morbidity related to multiple tracts , shorten the operation time and achieve a high stone-free rate .

###25075176
BACKGROUND	Hyperhidrosis is a chronic disease characterized by increased sweat production .
BACKGROUND	Local injections of botulinum toxin A ( BTX-A ) have been extensively used for treatment of primary hyperhidrosis ( idiopathic ) .
BACKGROUND	The current treatment for this condition involves several intradermal injections , resulting in poor patient compliance due to injection-related pain .
BACKGROUND	Therefore , new protocols , including an improved anesthetic regimen , are required .
OBJECTIVE	We designed the present study to determine whether JetPeel-3 , a medical device used for transdermal delivery of drugs by jet nebulization , could be used to deliver lidocaine prior to the standard multiple BTX-A injections or deliver lidocaine together with BTX-A in order to determine the protocol giving better results in terms of procedure-related pain , sweating , and patient satisfaction in subjects affected by primary axillary , palmar or plantar hyperhidrosis .
METHODS	Twenty patients with a visual analog scale ( VAS ) sweating score 8 cm were randomized to receive lidocaine 2 % ( 5 mL ) delivered by JetPeel-3 followed by multiple injections of BTX-A ( 100 units ) or lidocaine 2 % ( 5 mL ) and BTX-A ( 50 units ) delivered together by JetPeel-3 .
METHODS	Effect of treatment on sweating was measured by VAS ( 0 = minimum sweating ; 10 = maximum sweating ) at 3-month follow-up .
METHODS	Pain induced by the procedure was assessed by VAS ( 0 = minimum pain ; 10 = maximum pain ) immediately after the procedure .
METHODS	Patient satisfaction was assessed at 3-month follow-up using a 5-point scale ( 1 = not at all satisfied ; 2 = not satisfied ; 3 = partially satisfied ; 4 = satisfied ; 5 = highly satisfied ) .
RESULTS	Both treatment modalities reduced sweating at 3-month follow-up , if compared with baseline ( all P < 0.001 ) .
RESULTS	Delivery of lidocaine and BTX-A by JetPeel-3 resulted in lower procedure-related pain and reduced sweating , if compared with lidocaine delivered by JetPeel-3 followed by multiple BTX-A injections ( all P < 0.001 ) .
RESULTS	Patient satisfaction with the procedure was higher in the group receiving lidocaine and BTX-A treatment by JetPeel-3 , if compared with lidocaine delivered by JetPeel-3 followed by multiple BTX-A injections ( P < 0.001 ) .
RESULTS	No side effects were observed in both groups .
CONCLUSIONS	Lidocaine and BTX-A can be safely delivered together by JetPeel-3 to treat primary palmar , plantar and axillary hyperhidrosis , resulting in lower procedure-related pain , improved sweating and higher patient satisfaction , if compared with lidocaine delivered by JetPeel-3 followed by standard BTX-A injection therapy .
CONCLUSIONS	Our protocol delivering lidocaine and BTX-A together by JetPeel-3 requires a reduced quantity of BTX-A , further supporting the use of the transdermal drug delivery by jet nebulization over standard injection therapy for treatment of primary hyperhidrosis .

###24304594
BACKGROUND	There is increasing emphasis on the importance of intraocular pressure peaks and fluctuations as risk factors for glaucoma progression .
BACKGROUND	It is well recognized that the water drinking test raises intraocular pressure and there is reasonable evidence that caffeine can also raise intraocular pressure .
BACKGROUND	The aim of this study is to directly compare the effect of a caffeine test to that of the water drinking test on intraocular pressure , in patients with glaucoma .
METHODS	Prospective , observer-masked , cross-over study .
METHODS	Fourteen eyes of 14 patients with primary open-angle glaucoma .
METHODS	Patients were initially randomized to either caffeine test or water drinking test .
METHODS	Intraocular pressure was measured in both eyes with a Goldmann applanation tonometer at baseline and every 15min for 1h , by a masked examiner .
METHODS	This was repeated the following week at the same time of day for the other test ( the cross-over ) .
METHODS	Peak intraocular pressure and maximum fluctuation from baseline were compared between groups using paired t-tests .
METHODS	Peak and fluctuation of intraocular pressure , time of maximum frequency of peak intraocular pressure .
RESULTS	The maximum intraocular pressure from the water drinking test ( 19.74.1 ) was greater than the caffeine test ( 16.74.1 ) and showed greater fluctuation in intraocular pressure ( 4.32.7 mmHg [ 27.7 % ] ; P < 0.0001 ) compared with the caffeine test ( 1.81.9 mmHg [ 11.7 % ] ) ; P = 0.004 ) .
CONCLUSIONS	The rise in intraocular pressure was greater with water drinking test than the caffeine test .
CONCLUSIONS	Caffeine does not appear to provide an alternative for patients unable to tolerate the water drinking test .

###24269911
BACKGROUND	Patients with knee and/or hip osteoarthritis ( OA ) are less physically active than the general population , while the benefits of physical activity ( PA ) have been well documented .
BACKGROUND	Based on the behavioral graded activity treatment , we developed a Web-based intervention to improve PA levels in patients with knee and/or hip OA , entitled `` Join2move '' .
BACKGROUND	The Join2move intervention is a self-paced 9-week PA program in which the patient 's favorite recreational activity is gradually increased in a time-contingent way .
OBJECTIVE	The aim of the study was to investigate whether a fully automated Web-based PA intervention in patients with knee and/or hip OA would result in improved levels of PA , physical function , and self-perceived effect compared with a waiting list control group .
METHODS	The study design was a two-armed randomized controlled trial which was not blinded .
METHODS	Volunteers were recruited via articles in newspapers and health-related websites .
METHODS	Eligibility criteria for participants were : ( 1 ) aged 50-75 years , ( 2 ) self-reported knee and/or hip OA , ( 3 ) self-reported inactivity ( 30 minutes of moderate PA , 5 times or less per week ) , ( 4 ) no face-to-face consultation with a health care provider other than general practitioners , for OA in the last 6 months , ( 5 ) ability to access the Internet weekly , and ( 6 ) no contra-indications to exercise without supervision .
METHODS	Baseline , 3-month , and 12-month follow-up data were collected through online questionnaires .
METHODS	Primary outcomes were PA , physical function , and self-perceived effect .
METHODS	In a subgroup of participants , PA was measured objectively using accelerometers .
METHODS	Secondary outcomes were pain , fatigue , anxiety , depression , symptoms , quality of life , self-efficacy , pain coping , and locus of control .
RESULTS	Of the 581 interested respondents , 199 eligible participants were randomly assigned to the intervention ( n = 100 ) or waiting list control group ( n = 99 ) .
RESULTS	Response rates of questionnaires were 84.4 % ( 168/199 ) after 3 months and 75.4 % ( 150/199 ) after 12 months .
RESULTS	In this study , 94.0 % ( 94/100 ) of participants actually started the program , and 46.0 % ( 46/100 ) reached the adherence threshold of 6 out of 9 modules completed .
RESULTS	At 3 months , participants in the intervention group reported a significantly improved physical function status ( difference = 6.5 points , 95 % CI 1.8-11 .2 ) and a positive self-perceived effect ( OR 10.7 , 95 % CI 4.3-26 .4 ) compared with the control group .
RESULTS	No effect was found for self-reported PA. .
RESULTS	After 12 months , the intervention group showed higher levels of subjective ( difference = 21.2 points , 95 % CI 3.6-38 .9 ) and objective PA ( difference = 24 minutes , 95 % CI 0.5-46 .8 ) compared with the control group .
RESULTS	After 12 months , no effect was found for physical function ( difference = 5 points , 95 % CI -1.0 to 11.0 ) and self-perceived effect ( OR 1.2 , 95 % CI 0.6-2 .4 ) .
RESULTS	For several secondary endpoints , the intervention group demonstrated improvements in favor of the intervention group .
CONCLUSIONS	Join2move resulted in changes in the desired direction for several primary and secondary outcomes .
CONCLUSIONS	Given the benefits and its self-help format , Join2move could be a component in the effort to enhance PA in sedentary patients with knee and/or hip OA .

###24251381
OBJECTIVE	The pathophysiological role of iron in Parkinson 's disease ( PD ) was assessed by a chelation strategy aimed at reducing oxidative damage associated with regional iron deposition without affecting circulating metals .
OBJECTIVE	Translational cell and animal models provided concept proofs and a delayed-start ( DS ) treatment paradigm , the basis for preliminary clinical assessments .
RESULTS	For translational studies , we assessed the effect of oxidative insults in mice systemically prechelated with deferiprone ( DFP ) by following motor functions , striatal dopamine ( HPLC and MRI-PET ) , and brain iron deposition ( relaxation-R2 * - MRI ) aided by spectroscopic measurements of neuronal labile iron ( with fluorescence-sensitive iron sensors ) and oxidative damage by markers of protein , lipid , and DNA modification .
RESULTS	DFP significantly reduced labile iron and biological damage in oxidation-stressed cells and animals , improving motor functions while raising striatal dopamine .
RESULTS	For a pilot , double-blind , placebo-controlled randomized clinical trial , early-stage Parkinson 's patients on stabilized dopamine regimens enrolled in a 12-month single-center study with DFP ( 30 mg/kg/day ) .
RESULTS	Based on a 6-month DS paradigm , early-start patients ( n = 19 ) compared to DS patients ( n = 18 ) ( 37/40 completed ) responded significantly earlier and sustainably to treatment in both substantia nigra iron deposits ( R2 * MRI ) and Unified Parkinson 's Disease Rating Scale motor indicators of disease progression ( p < 0.03 and p < 0.04 , respectively ) .
RESULTS	Apart from three rapidly resolved neutropenia cases , safety was maintained throughout the trial .
METHODS	A moderate iron chelation regimen that avoids changes in systemic iron levels may constitute a novel therapeutic modality for PD .
CONCLUSIONS	The therapeutic features of a chelation modality established in translational models and in pilot clinical trials warrant comprehensive evaluation of symptomatic and/or disease-modifying potential of chelation in PD .

###24857206
OBJECTIVE	To compare the efficacy and toxicity of the chemotherapeutic regimen containing pirarubicin and mitoxantrone on the treatment of relapsed or refractory acute myeloid leukemia ( AML ) in adults .
METHODS	In this open prospective multicentre study , we randomly assigned patients with relapsed or refractory AML to receive TAE regimen ( pirarubicin + cytarabine + etoposide ) versus MAE regimen ( mitoxantrone + cytarabine + etoposide ) .
METHODS	The efficacy and toxicity were compared between the two groups .
RESULTS	56 patients entered this clinical trial .
RESULTS	The complete remission ( CR ) rate on TAE arm was 79.0 % versus 55.6 % on MAE arm with the overall response ( OR ) rates of 86.8 % versus 88.9 % , respectively .
RESULTS	The CR was higher on TAE arm ( P = 0.035 ) but with no significant difference between the two groups regarding the overall response ( OR ) rate .
RESULTS	The regimens were well tolerated in both groups .
RESULTS	Hematologic and non-hematologic toxicity were similar except relatively lower the mean dosage of G-CSF , red blood cells and platelets transfusion on TAE arm .
RESULTS	No significant differences were seen between the two groups regarding the overall survival and relapse free survival rates .
CONCLUSIONS	TAE regimen might be an effective salvage therapy in patients with relapsed or refractory AML .

###25178809
BACKGROUND	Tuberculous pericarditis is associated with high morbidity and mortality even if antituberculosis therapy is administered .
BACKGROUND	We evaluated the effects of adjunctive glucocorticoid therapy and Mycobacterium indicus pranii immunotherapy in patients with tuberculous pericarditis .
METHODS	Using a 2-by-2 factorial design , we randomly assigned 1400 adults with definite or probable tuberculous pericarditis to either prednisolone or placebo for 6 weeks and to either M. indicus pranii or placebo , administered in five injections over the course of 3 months .
METHODS	Two thirds of the participants had concomitant human immunodeficiency virus ( HIV ) infection .
METHODS	The primary efficacy outcome was a composite of death , cardiac tamponade requiring pericardiocentesis , or constrictive pericarditis .
RESULTS	There was no significant difference in the primary outcome between patients who received prednisolone and those who received placebo ( 23.8 % and 24.5 % , respectively ; hazard ratio , 0.95 ; 95 % confidence interval [ CI ] , 0.77 to 1.18 ; P = 0.66 ) or between those who received M. indicus pranii immunotherapy and those who received placebo ( 25.0 % and 24.3 % , respectively ; hazard ratio , 1.03 ; 95 % CI , 0.82 to 1.29 ; P = 0.81 ) .
RESULTS	Prednisolone therapy , as compared with placebo , was associated with significant reductions in the incidence of constrictive pericarditis ( 4.4 % vs. 7.8 % ; hazard ratio , 0.56 ; 95 % CI , 0.36 to 0.87 ; P = 0.009 ) and hospitalization ( 20.7 % vs. 25.2 % ; hazard ratio , 0.79 ; 95 % CI , 0.63 to 0.99 ; P = 0.04 ) .
RESULTS	Both prednisolone and M. indicus pranii , each as compared with placebo , were associated with a significant increase in the incidence of cancer ( 1.8 % vs. 0.6 % ; hazard ratio , 3.27 ; 95 % CI , 1.07 to 10.03 ; P = 0.03 , and 1.8 % vs. 0.5 % ; hazard ratio , 3.69 ; 95 % CI , 1.03 to 13.24 ; P = 0.03 , respectively ) , owing mainly to an increase in HIV-associated cancer .
CONCLUSIONS	In patients with tuberculous pericarditis , neither prednisolone nor M. indicus pranii had a significant effect on the composite of death , cardiac tamponade requiring pericardiocentesis , or constrictive pericarditis .
CONCLUSIONS	( Funded by the Canadian Institutes of Health Research and others ; IMPI ClinicalTrials.gov number , NCT00810849 . )

###25437881
OBJECTIVE	Osteoporosis and cardiovascular disease may share common biological pathways , with inflammation playing a role in the development of both .
OBJECTIVE	Although observational studies have suggested that statin use is associated with a lower risk of fractures , randomized trial data addressing this issue are scant .
OBJECTIVE	To determine whether statin therapy reduces the risk of fracture and , in a secondary analysis , whether baseline levels of the inflammatory biomarker high-sensitivity C-reactive protein ( hs-CRP ) are associated with the risk of fracture .
METHODS	The JUPITER ( Justification for the Use of Statins in Prevention : an Intervention Trial Evaluating Rosuvastatin ) trial was an international , randomized , double-blind , placebo-controlled study enrolling 17,802 men older than 50 years and women older than 60 years with hs-CRP level of at least 2 mg/L .
METHODS	Participants were screened from 2003 to 2006 and observed prospectively for up to 5 years ( median follow-up , 1.9 years ) .
METHODS	Rosuvastatin calcium , 20 mg daily , or placebo .
METHODS	Incident fracture was a prespecified secondary end point of JUPITER .
METHODS	Fractures were confirmed by radiographs , computed tomography , bone scan , or other methods .
METHODS	Cox proportional hazards models were used to calculate hazard ratios ( HRs ) and associated 95 % confidence intervals for the risk of fracture according to randomized treatment assignment , as well as increasing tertiles of hs-CRP , controlling for potential confounders .
RESULTS	During the study , 431 incident fractures were reported and confirmed .
RESULTS	Among participants allocated to rosuvastatin , 221 fractures were confirmed , compared with 210 among those allocated to placebo , such that the incidence of fracture in the rosuvastatin and placebo groups was 1.20 and 1.14 per 100 person-years , respectively ( adjusted HR , 1.06 [ 95 % CI , 0.88-1 .28 ] ; P = .53 ) .
RESULTS	Overall , increasing baseline hs-CRP level was not associated with an increased risk of fractures ( adjusted HR for each unit increase in hs-CRP tertile , 1.06 [ 95 % CI , 0.94-1 .20 ] ; P for trend , .34 ) .
CONCLUSIONS	Among men and women with elevated hs-CRP level enrolled in a large trial of rosuvastatin therapy for cardiovascular disease , statin therapy did not reduce the risk of fracture .
CONCLUSIONS	Higher baseline hs-CRP level was not associated with an increased risk of incident fracture .
BACKGROUND	clinicaltrials.gov Identifier : NCT00239681 .

###24898640
BACKGROUND	Primary data about rates of formal diagnosis of dementia in the German primary care sector are widely lacking .
OBJECTIVE	Main objectives are to analyze the rate of syndrome diagnosis in primary care patients who screened positive for dementia , the distribution of differential diagnoses , and factors associated with undiagnosed dementia .
METHODS	DelpHi-MV ( Dementia : life - and person-centered help in Mecklenburg-Western Pomerania ) is an ongoing general practitioner ( GP ) - based , randomized , controlled intervention trial .
METHODS	A total of 4,064 patients ( 70 years , living at home ) recruited from 108 participating GP practices were screened for dementia ( DemTect < 9 ) .
METHODS	Of 692 eligible patients ( 17 % ) , a total of 406 subjects ( 59 % ) provided informed consent .
METHODS	Present analyses are based on the data of 243 patients with complete baseline assessment on January 1 , 2014 ( preliminary data ) .
METHODS	Formal diagnoses were retrieved from the medical records of the treating GPs .
METHODS	A conditional fixed effect regression analysis was performed to analyze factors associated with undiagnosed dementia .
RESULTS	A total of 40 % of patients who screened positive for dementia had been formally diagnosed with dementia .
RESULTS	Unspecified dementia was diagnosed in 53 % , vascular dementia in 24 % , and Alzheimer 's disease in 19 % of these patients .
RESULTS	Undiagnosed dementia was significantly associated with a higher mean score in the Mini-Mental State Examination ( odds ratio , 1.11 ; p < 0.01 , 95 % confidence interval 1.04-1 .18 ) .
CONCLUSIONS	The diagnosis rate of dementia in German primary care ( 40 % ) is well within the range of the international data ( 20-50 % ) .
CONCLUSIONS	The results emphasize the need for action to enhance recognition and differential diagnosis of dementia .

###24840109
OBJECTIVE	The aim was to test a new protocol of luteal phase administration of clomiphene citrate ( CC ) for ovulation induction in women with polycystic ovary syndrome ( PCOS ) .
METHODS	This was a prospective , randomized , controlled trial .
METHODS	Two hundred and fifty-two women ( cycles ) with PCOS were utilized to create two groups .
METHODS	Patients in Group 1 ( 126 patients ) received 100mg of CC daily for 5days starting on day 5 of menses , and patients in Group 2 ( 126 patients ) received 100mg of CC daily for 5days starting the next day after finishing medroxyprogesterone acetate ( MPA ) ( before withdrawal bleeding ) .
METHODS	The main outcome measures were the number of growing and mature follicles , serum E2 ( in pg/mL ) , serum progesterone ( in ng/mL ) levels , endometrial thickness ( in mm ) , pregnancy , and miscarriage rates .
RESULTS	The total number of follicles and the number of follicles 14mm during stimulation were significantly greater in Group 2 .
RESULTS	The endometrial thickness at the time of human chorionic gonadotrophin ( hCG ) administration was significantly greater in Group 2 as compared to Group 1 ( 7.841.22 and 8.810.9 , respectively ) .
RESULTS	Serum E2 levels were also significantly higher ( p < 0.05 ) in Group 2 as compared to Group 1 ( 449.61243.45 vs. 666.09153.41 pg/mL ) .
RESULTS	Pregnancy occurred in 13 patients ( 10.3 % ) in Group 2 and in 11 patients ( 8.7 % ) in Group 1 .
RESULTS	The difference was not statistically significant .
CONCLUSIONS	Luteal phase administration of CC in patients with PCOS leads to increased follicular growth and endometrial thickness , which might result in a higher pregnancy rate .

###24438478
BACKGROUND	The risks associated with gestational diabetes mellitus ( GDM ) are well recognized , and there is increasing evidence to support treatment of the condition .
BACKGROUND	However , clear guidance on the ideal approach to screening for GDM is lacking .
BACKGROUND	Professional groups continue to debate whether selective screening ( based on risk factors ) or universal screening is the most appropriate approach .
BACKGROUND	Additionally , there is ongoing debate about what levels of glucose abnormalities during pregnancy respond best to treatment and which maternal and neonatal outcomes benefit most from treatment .
BACKGROUND	Furthermore , the implications of possible screening options on health care costs are not well established .
BACKGROUND	In response to this uncertainty there have been repeated calls for well-designed , randomised trials to determine the efficacy of screening , diagnosis , and management plans for GDM .
BACKGROUND	We describe a randomised controlled trial to investigate screening uptake rates and the clinical and cost effectiveness of screening in primary versus secondary care settings .
METHODS	This will be an unblinded , two-group , parallel randomised controlled trial ( RCT ) .
METHODS	The target population includes 784 women presenting for their first antenatal visit at 12 to 18 weeks gestation at two hospitals in the west of Ireland : Galway University Hospital and Mayo General Hospital .
METHODS	Participants will be offered universal screening for GDM at 24 to 28 weeks gestation in either primary care ( n = 392 ) or secondary care ( n = 392 ) locations .
METHODS	The primary outcome variable is the uptake rate of screening .
METHODS	Secondary outcomes include indicators of clinical effectiveness of screening at each screening site ( primary and secondary ) including gestational week at time of screening , time to access antenatal diabetes services for women diagnosed with GDM , and pregnancy and neonatal outcomes for women with GDM .
METHODS	In addition , parallel economic and qualitative evaluations will be conducted .
METHODS	The trial will cover the period from the woman 's first hospital antenatal visit at 12 to 18 weeks gestation , until the completion of the pregnancy .
BACKGROUND	Current Controlled Trials : ISRCTN02232125 .

###24714773
OBJECTIVE	We report the role of relative lymphocyte count ( RLC ) as a potential biomarker with prognostic impact for catumaxomab efficacy and overall survival ( OS ) based on a post hoc analysis of the pivotal phase II/III study of intraperitoneal catumaxomab treatment of malignant ascites .
METHODS	The impact of treatment and RLC on OS was evaluated using multivariate Cox models .
METHODS	Kaplan-Meier and log-rank tests were used for group comparisons .
METHODS	Survival analyses were performed on the safety population [ patients with paracentesis plus 1 dose of catumaxomab ( n = 157 ) and paracentesis alone ( n = 88 ) ] .
METHODS	Determination of the optimal cutoff value for RLC was based on five optimality criteria .
RESULTS	OS was significantly longer with catumaxomab versus paracentesis alone ( P = 0.0219 ) .
RESULTS	The 6-month OS rate with catumaxomab was 28.9 % versus 6.7 % with paracentesis alone .
RESULTS	RLC had a positive impact on OS and was an independent prognostic factor ( P < 0.0001 ) .
RESULTS	In patients with RLC > 13 % ( n = 159 : catumaxomab , 100 and control , 59 ) , catumaxomab was associated with a favorable effect on OS versus paracentesis alone ( P = 0.0072 ) , with a median/mean OS benefit of 41/131 days and an increased 6-month survival rate of 37.0 % versus 5.2 % , respectively .
RESULTS	In patients with RLC 13 % at screening ( n = 74 : catumaxomab , 50 and control , 24 ) , the median ( mean ) OS difference between the catumaxomab and the control group was 3 ( 16 ) days , respectively ( P = 0.2561 ) .
CONCLUSIONS	OS was significantly improved after catumaxomab treatment in patients with malignant ascites .
CONCLUSIONS	An RLC > 13 % at baseline was a significant prognostic biomarker .

###25440792
BACKGROUND	Primary percutaneous coronary intervention ( PCI ) has considerably improved clinical outcomes in patients with ST-segment elevation myocardial infarction ( STEMI ) when compared with thrombolytic therapy .
BACKGROUND	Prognosis after primary PCI might be further improved by decreasing stent-related complications such as stent thrombosis .
BACKGROUND	The STENTYS self-apposing stent has been shown to be superior compared with balloon-expandable stents with regard to stent apposition .
BACKGROUND	The current prospective randomized trial was designed to evaluate whether the superior stent apposition of the STENTYS stent results in clinical outcomes that are at least noninferior to a conventional balloon-expandable stent .
METHODS	The APPOSITION V is a prospective , multicenter , international , single-blinded , randomized controlled trial in STEMI patients .
METHODS	Randomization will be performed in a 2:1 ratio between the self-apposing nitinol bare-metal STENTYS stent and the balloon-expandable bare-metal MULTI-LINK .
METHODS	The primary end point is defined as target vessel failure , which is a composite of cardiac death , target vessel-related recurrent myocardial infarction , or clinically driven target vessel revascularization , at 1-year follow-up .
METHODS	Baseline intravascular ultrasound and optical coherence tomography ( OCT ) substudies will be performed in 212 and 60 subjects , respectively , and a repeat angiography at 12 to 13 months will be performed in 105 subjects , including intravascular ultrasound and OCT ( in the 60 OCT patients ) .
METHODS	This study is registered on ClinicalTrials.gov with number NCT01732341 .
CONCLUSIONS	APPOSITION V will be the first randomized trial powered on clinical end points that directly compares the STENTYS self-apposing stent with a conventional balloon-expandable stent in patients presenting with STEMI undergoing primary PCI .

###24582042
BACKGROUND	Reliability of coronary angiography by multidetector row CT ( MDCT-CA ) for stent evaluation is still a matter for debate , and it is unknown whether contrast medium characteristics may affect diagnostic performance of MDCT-CA .
OBJECTIVE	We compared iomeprol-400 with iodixanol-320 to evaluate coronary stents with MDCT-CA .
METHODS	We randomly assigned 254 patients undergoing coronary stent follow-up with the use of MDCT-CA to iomeprol-400 at 5.0 mL/sec flow rate ( group 1 ; n = 83 ) , iodixanol-320 at 6.2 mL/sec flow rate ( group 2 ; n = 87 ) , and iodixanol-320 at 5.0 mL/sec flow rate ( group 3 ; n = 84 ) .
METHODS	Heart rate ( HR ) immediately before and at the end of scanning , HR variation , premature heart beats , and heat sensation by visual analog scale during scanning were recorded .
METHODS	Mean attenuation was measured in the aortic root and coronary arteries .
METHODS	Image quality score and type of artifacts were assessed .
RESULTS	Mean attenuation was significantly lower in group 3 than in the other groups .
RESULTS	In group 3 , stent evaluability was significantly higher and artifact rate was significantly lower than in group 2 ( 99 % vs. 91 % and 4 % vs. 15 % ) and group 1 ( 99 % vs. 92 % and 4 % vs. 17 % ) , respectively , mainly because of a significant lower rate of beam-hardening artifacts ( 3 cases in group 3 vs. 22 and 27 in groups 2 and 3 , respectively ) .
RESULTS	In group 3 , visual analog scale , HR at the end of imaging , and number of patients with premature heart beats during the scan were significantly lower than in the other groups .
CONCLUSIONS	Iodixanol-320 provides better image quality of coronary stents , allowing higher MDCT-CA evaluability , than iomeprol-400 .

###25296098
OBJECTIVE	The efficacy of pre-exposure prophylaxis ( PrEP ) in HIV will diminish with poor adherence ; pharmacologic measures of drug exposure have proven critical to PrEP trial interpretation .
OBJECTIVE	We assessed drug exposure in hair against other pharmacologic and more routinely used measures to assess pill-taking .
METHODS	Participants were randomized to placebo , daily PrEP , or intermittent PrEP to evaluate safety and tolerability of daily versus intermittent tenofovir/emtricitabine ( TFV/FTC ) in 2 phase II PrEP clinical trials conducted in Africa .
METHODS	Different measures of drug exposure , including self-report , medication event monitoring system ( MEMS ) - caps openings , and TFV/FTC levels in hair and other biomatrices were compared .
METHODS	At weeks 8 and 16 , self-reported pill-taking , MEMS-caps openings , and TFV/FTC levels in hair , plasma , and peripheral blood mononuclear cells ( PBMCs ) were measured .
METHODS	Regression models evaluated predictors of TFV/FTC concentrations in the 3 biomatrices ; correlation coefficients between pharmacologic and nonpharmacologic measures were calculated .
METHODS	Both trials were registered on ClinicalTrials.gov ( NCT00931346/NCT00971230 ) .
RESULTS	Hair collection was highly feasible and acceptable ( 100 % in week 8 ; 96 % in week 16 ) .
RESULTS	In multivariate analysis , strong associations were seen between pharmacologic measures and MEMS-caps openings ( all P < 0.001 ) ; self-report was only weakly associated with pharmacologic measures .
RESULTS	TFV/FTC hair concentrations were significantly correlated with levels in plasma and PBMCs ( correlation coefficients , 0.41-0 .86 , all P < 0.001 ) .
CONCLUSIONS	Measuring TFV/FTC exposure in small hair samples in African PrEP trials was feasible and acceptable .
CONCLUSIONS	Hair levels correlated strongly with PBMC , plasma concentrations , and MEMS-caps openings .
CONCLUSIONS	As in other PrEP trials , self-report was the weakest measure of exposure .
CONCLUSIONS	Further study of hair TFV/FTC levels in PrEP trials and demonstration projects to assess adherence/exposure is warranted .

###24561163
BACKGROUND	Sleep apnea ( SA ) is associated with cardiovascular diseases and is highly prevalent in patients with pacemakers ( PMs ) .
OBJECTIVE	To validate a transthoracic impedance sensor with an advanced algorithm ( sleep apnea monitoring ) for identifying severe SA .
METHODS	Patients with indications for PM ( VVI/DDD ) were enrolled regardless of symptoms suggesting SA .
METHODS	Severe SA diagnosis was acknowledged when the full polysomnography gave an apnea-hypopnea index ( PSG-AHI ) of 30 events/h .
METHODS	The PSG-AHI was compared with the respiratory disturbance index evaluated by the SAM algorithm ( SAM-RDI ) compiled from the device during the same diagnosis night , and the performance of the device and the SAM algorithm was calculated to identify patients with severe SA .
METHODS	The agreement between methods was assessed by using Bland and Altman statistics .
RESULTS	Forty patients ( mean age 73.8 19.1 years ; 67.5 % men ; body mass index 27.7 4.4 kg/m ( 2 ) ) were included .
RESULTS	Severe SA was diagnosed by PSG in 56 % of the patients .
RESULTS	We did not retrieve SAM-RDI data in 14 % of the patients .
RESULTS	An optimal cutoff value for the SAM-RDI at 20 events/h was obtained by a receiver operator characteristic curve analysis , which yielded a sensitivity of 88.9 % ( 95 % confidence interval [ CI ] 65.3 % -98.6 % ) , a positive predictive value of 88.9 % ( 95 % CI 65.3 % -98.6 % ) , and a specificity of 84.6 % ( 95 % CI 54.6 % -98.1 % ) ( n = 31 ) .
RESULTS	The Bland-Altman limits of agreement for PSG-AHI ( in events per hour ) were [ -14.1 to 32.4 ] .
CONCLUSIONS	The results suggest that an advanced algorithm using PM transthoracic impedance could be used to identify SA in patients with PMs outside the clinic or at home .

###24948466
BACKGROUND	Although maintenance bacillus Calmette-Gurin ( BCG ) is the recommended treatment in high-risk non-muscle-invasive bladder cancer ( NMIBC ) , its efficacy in older patients is controversial .
OBJECTIVE	To determine the effect of age on prognosis and treatment outcome in patients with stage Ta T1 NMIBC treated with maintenance BCG .
METHODS	A total of 957 patients with intermediate - or high-risk Ta T1 ( without carcinoma in situ ) NMIBC were randomized in European Organization for Research and Treatment of Cancer ( EORTC ) trial 30911 comparing six weekly instillations of epirubicin , BCG , and BCG plus isoniazid followed by three weekly maintenance instillations over 3 yr .
METHODS	Cox multivariate proportional hazards regression models were used to assess the relative importance of age for recurrence , progression , overall survival , and NMIBC-specific survival with adjustment for EORTC risk scores .
CONCLUSIONS	Overall , 822 eligible patients were included : 546 patients in the BCG with or without INH arms and 276 in the epirubicin arm .
CONCLUSIONS	In patients treated with BCG with or without INH , 34.1 % were > 70 yr of age and 3.7 % were > 80 yr .
CONCLUSIONS	With a median follow-up of 9.2 yr , patients > 70 yr had a shorter time to progression ( p = 0.028 ) , overall survival ( p < 0.001 ) , and NMIBC-specific survival ( p = 0.049 ) after adjustment for EORTC risk scores in the multivariate analysis .
CONCLUSIONS	The time to recurrence was similar compared with the younger patients .
CONCLUSIONS	BCG was more effective than epirubicin for all four end points considered , and there was no evidence that BCG was any less effective compared with epirubicin in patients > 70 yr .
CONCLUSIONS	In intermediate - and high-risk Ta T1 urothelial bladder cancer patients treated with BCG , patients > 70 yr of age have a worse long-term prognosis ; however , BCG is more effective than epirubicin independent of patient age .
RESULTS	Intravesical bacillus Calmette-Gurin for non-muscle-invasive bladder cancer is less effective in patients > 70 yr of age , but it is still more effective than epirubicin .
BACKGROUND	This study was registered with the US National Cancer Institute clinical trials database ( protocol ID : EORTC 30911 ; http://www.cancer.gov/clinicaltrials/search/view?cdrid=77075&version=HealthProfessional&protocolsearchid=12442243#StudyIdInfo_CDR0000077075 ) .

###25468282
BACKGROUND	Patients with end stage renal disease on hemodialysis are affected by physiological and psychological stressors , which contribute to poor quality of life and negative clinical outcomes .
BACKGROUND	Depression , anxiety , and stress are highly prevalent in this population .
BACKGROUND	Effective interventional strategies are required to manage these psychological symptoms .
BACKGROUND	Acupressure has been believed to be one of the complementary therapies that could promote psychological wellbeing .
OBJECTIVE	The aim of this study was to evaluate the effects of acupressure on depression , anxiety , stress , and general psychological distress in patients with hemodialysis .
METHODS	Open-label randomized controlled trial .
METHODS	Three hemodialysis centers .
METHODS	A total of 108 patients with hemodialysis were randomly recruited into the acupressure group ( n = 54 ) and the control group ( n = 54 ) .
METHODS	The intervention was carried out from January to March 2014 .
METHODS	The acupressure group received routine hemodialysis treatment plus 15 min acupressure applied three times a week for four weeks .
METHODS	The control group received only usual care with routine hemodialysis treatment .
METHODS	The outcome measurements were the Depression , Anxiety Stress Scales ( DASS-21 ) , and general psychological distress using the General Health Questionnaire ( GHQ-28 ) .
METHODS	Statistical analysis was performed using Wilcoxon signed-rank test to compare DASS scales and GHQ-28 scores before and after acupressure intervention .
RESULTS	The acupressure group had significantly lower DASS scores and GHQ scores compared to the control group , signifying improvements in depression , anxiety , stress and general psychological distress .
RESULTS	The sub-score of the GHQ-28 for social dysfunction , however , were similar in both groups .
CONCLUSIONS	Findings from this study indicates that acupressure therapy delivered three times a week for four weeks was able to significantly reduce depression , anxiety , stress , and general psychological distress in patients with hemodialysis .
CONCLUSIONS	This positive finding suggests that acupressure may have a role in promoting psychological wellbeing of patients .
CONCLUSIONS	Promoting psychological wellness will improve patients ' quality of life , and reduce negative outcomes associated with psychological illnesses and distress experienced by patients with hemodialysis .

###24593323
BACKGROUND	Botulinum toxins have been widely used in cosmetic dermatology .
BACKGROUND	Neurotoxin from the CBFC26 strain ( NTC ) is a recently developed botulinum toxin type A product manufactured through refined procedures .
OBJECTIVE	A double-blinded , randomized , multicentre-designed , phase III trial to investigate the non-inferiority of NTC to existing botulinum toxin A , onabotulinumtoxin A in the treatment of moderate to severe glabellar lines .
METHODS	A total of 272 subjects were randomized in a 1 : 1 ratio to receive 20 U of NTC or onabotulinumtoxin A.
METHODS	The primary endpoint was the response rate of physicians ' assessment ( PA ) using the Facial Wrinkle Scale at week 4 .
METHODS	The secondary endpoints included the response rate of PA at weeks 8 , 12 and 16 , and photographic assessment at weeks 4 , 8 , 12 and 16 .
METHODS	Subjects ' improvement assessment and subjective self-satisfaction levels were also investigated .
RESULTS	Response rates for maximum frown were 89.3 % in the NTC group and 81.9 % in the onabotulinumtoxin A group at week 4 .
RESULTS	NTC also resulted in comparable results for both the response rates of the other evaluation points and incidence of adverse events compared to those of onabotulinumtoxin A.
RESULTS	In subjects ' improvement assessment and photographic evaluations , NTC even demonstrated better results compared with onabotulinumtoxin A in the early phase after treatment .
RESULTS	Analysis of these results strongly supports the non-inferiority of NTC to onabotulinumtoxin A in the efficacy and safety .
CONCLUSIONS	NTC is as effective as onabotulinumtoxin A in the treatment of glabellar lines , and both products were well tolerated .

###25234040
OBJECTIVE	To determine whether endometrial hCG infusion at the time of human blastocyst transfer impacts implantation rates .
METHODS	Randomized double-blinded placebo-controlled trial .
METHODS	Academic .
METHODS	Infertile couples with the female partner less than 43 years old ( n = 300 ) undergoing fresh or frozen ET of one or two blastocysts .
METHODS	Patients undergoing ET were randomized into either a treatment or a control group .
METHODS	The treatment group received an infusion of 500 IU of hCG diluted in ET media .
METHODS	The control group received a sham infusion of ET media .
METHODS	Infusions were done using a separate catheter less than 3 minutes before actual ET .
METHODS	Sustained implantation rate : ongoing viable gestation ( primary outcome ) and ongoing pregnancy rate ( secondary outcome ) .
RESULTS	A total of 473 blastocysts were transferred into 300 patients .
RESULTS	There were no differences between the two groups in sustained implantation rate ( 48.1 % in the hCG group , 44.2 % in the control group ) or ongoing pregnancy rate ( 58.8 % in the hCG group , 52.0 % in the control group ) .
CONCLUSIONS	Endometrial infusion of hCG at the time of blastocyst ET does not improve sustained implantation rates .
BACKGROUND	NCT01643993 .

###24384592
BACKGROUND	Daily oral antiretroviral preexposure prophylaxis ( PrEP ) is a promising strategy for prevention of HIV-1 acquisition .
BACKGROUND	Three clinical trials demonstrated PrEP efficacy ; however , two PrEP trials among women did not find protection against HIV-1 .
BACKGROUND	One hypothesis proposed for these divergent results is that PrEP efficacy may be reduced in populations with higher HIV-1 incidence .
METHODS	Using data from the Partners PrEP Study , a randomized , placebo-controlled trial of daily oral tenofovir ( TDF ) and emtricitabine/tenofovir ( FTC/TDF ) PrEP among heterosexual HIV-1 serodiscordant couples from Kenya and Uganda , we assessed PrEP efficacy among subgroups at higher risk for HIV-1 acquisition , including subgroups of women with high HIV-1 incidence .
RESULTS	The overall placebo arm HIV-1 incidence was 2.0 per 100 person-years .
RESULTS	Among higher risk subgroups , placebo arm HIV-1 incidence ranged from 3.9 to 6.6 per 100 person-years .
RESULTS	In all subgroups , PrEP was protective against HIV-1 acquisition , with efficacy point estimates ranging from 64 to 84 % .
RESULTS	Among subgroups of women with placebo-arm HIV-1 incidence more than 5.0 , efficacy estimates ranged from 64 to 84 % .
RESULTS	Monthly visit attendance for PrEP refills and tenofovir detection in plasma were high .
CONCLUSIONS	Among higher-risk subgroups in the Partners PrEP Study , including groups solely of higher-risk women , both TDF alone and combined FTC/TDF PrEP had consistently high efficacy for HIV-1 protection .
CONCLUSIONS	PrEP , when used with high adherence , is a highly effective prevention strategy for higher risk heterosexuals .
CONCLUSIONS	Prioritizing PrEP for persons at high risk of HIV-1 will maximize its prevention impact .

###25034862
BACKGROUND	The anti-programmed-death-receptor-1 ( PD-1 ) antibody pembrolizumab has shown potent antitumour activity at different doses and schedules in patients with melanoma .
BACKGROUND	We compared the efficacy and safety of pembrolizumab at doses of 2 mg/kg and 10 mg/kg every 3 weeks in patients with ipilimumab-refractory advanced melanoma .
METHODS	In an open-label , international , multicentre expansion cohort of a phase 1 trial , patients ( aged 18 years ) with advanced melanoma whose disease had progressed after at least two ipilimumab doses were randomly assigned with a computer-generated allocation schedule ( 1:1 final ratio ) to intravenous pembrolizumab at 2 mg/kg every 3 weeks or 10 mg/kg every 3 weeks until disease progression , intolerable toxicity , or consent withdrawal .
METHODS	Primary endpoint was overall response rate ( ORR ) assessed with the Response Evaluation Criteria In Solid Tumors ( RECIST , version 1.1 ) by independent central review .
METHODS	Analysis was done on the full-analysis set ( all treated patients with measurable disease at baseline ) .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01295827 .
RESULTS	173 patients received pembrolizumab 2 mg/kg ( n = 89 ) or 10 mg/kg ( n = 84 ) .
RESULTS	Median follow-up duration was 8 months .
RESULTS	ORR was 26 % at both doses -- 21 of 81 patients in the 2 mg/kg group and 20 of 76 in the 10 mg/kg group ( difference 0 % , 95 % CI -14 to 13 ; p = 096 ) .
RESULTS	Treatment was well tolerated , with similar safety profiles in the 2 mg/kg and 10 mg/kg groups and no drug-related deaths .
RESULTS	The most common drug-related adverse events of any grade in the 2 mg/kg and 10 mg/kg groups were fatigue ( 29 [ 33 % ] vs 31 [ 37 % ] ) , pruritus ( 23 [ 26 % ] vs 16 [ 19 % ] ) , and rash ( 16 [ 18 % ] vs 15 [ 18 % ] ) .
RESULTS	Grade 3 fatigue , reported in five ( 3 % ) patients in the 2 mg/kg pembrolizumab group , was the only drug-related grade 3 to 4 adverse event reported in more than one patient .
CONCLUSIONS	The results suggest that pembrolizumab at a dose of 2 mg/kg or 10 mg/kg every 3 weeks might be an effective treatment in patients for whom there are few effective treatment options .
BACKGROUND	Merck Sharp and Dohme .

###25495494
BACKGROUND	The aim of this study was to analyze diurnal profiles of physical activity for community-dwelling adults aged 70 years and over , and to explore the moderating effect of sex , age , morbidity , mobility limitation , and season on physical activity throughout the day .
METHODS	A sample of 149 primary health care patients ( mean age 79.5 5.2 years , 74.5 % females ) was included in the analyses .
METHODS	Participants ' physical activity was measured on up to six consecutive days via Omron Walking Style Pro HJ-720IT-E2 pedometer .
METHODS	Step count per day and per hour , and pedometer wear time were descriptively analyzed .
METHODS	A repeated measures ANOVA with physical activity per hour as dependent variable was performed to analyze the moderating effect of sex , age , morbidity , mobility limitation , and season on diurnal profiles of physical activity .
METHODS	The diurnal profile for the total sample and adjusted diurnal profiles for subgroups are presented .
RESULTS	Participants ' daily step count averaged 3280 1873 steps/day .
RESULTS	They wore the pedometer for 14.2 1.7 hours per day and walked on average 234 139 steps per hour .
RESULTS	With respect to diurnal profiles , there were two peaks at 10-11 AM ( mean [ 95 % - confidence interval ] : 382 [ 329-435 ] steps ) and at 3-4 pm ( 313 [ 261-365 ] steps ) interrupted by a period of lower activity with a low point at 1-2 pm ( 229 [ 190-268 ] steps ) .
RESULTS	A mobility limitation , defined by use of a cane or a rollator , had a significant moderating effect ( p = 0.0237 ) on diurnal physical activity .
CONCLUSIONS	This is the first study to explore pedometer-determined diurnal profiles of physical activity in chronically ill and mobility-limited older adults .
CONCLUSIONS	Prolonging periods of elevated physical activity in the afternoon while respecting individual daily routine and commitments could be one option for facilitating the integration of physical activity and for making it a habit in older adults ' daily lives .
CONCLUSIONS	The use of a walking aid seems to be an indicator for a quite low activity plateau during the second half of the day .
CONCLUSIONS	People who use walking aids should be motivated to increase their physical activity during afternoon ; this might help to increase the overall low physical activity level of this vulnerable subgroup of older adults .

###24947791
OBJECTIVE	We evaluated the endogenous glucose production ( EGP ) and glucose disposal rate ( GDR ) over a range of doses of basal insulin peglispro ( BIL ) and insulin glargine in healthy subjects .
METHODS	This was a single-center , randomized , open-label , four-period , incomplete-block , crossover study conducted in eight healthy male subjects .
METHODS	Subjects had 8-h euglycemic clamps performed with primed , continuous infusions of BIL ( 5.1 to 74.1 mU/min ) in three dosing periods and insulin glargine ( 20 or 30 mU/m ( 2 ) / min ) in a fourth period , targeted to achieve 50-100 % suppression of EGP .
METHODS	D - [ 3 - ( 3 ) H ] glucose was infused to assess rates of glucose appearance and disappearance .
RESULTS	Mean BIL and insulin glargine concentrations ( targeted to reflect the differences in intrinsic affinities of the two basal insulins ) ranged from 824 to 11,400 and 212 to 290 pmol/L , respectively , and increased accordingly with increases in dose .
RESULTS	Suppression of EGP and stimulation of GDR were observed with increasing concentrations of both insulins .
RESULTS	At insulin concentrations where EGP was significantly suppressed , insulin glargine resulted in increased GDR .
RESULTS	In contrast , at comparable suppression of EGP , BIL had minimal effect on GDR at lower doses and had substantially less effect on GDR than insulin glargine at higher doses .
CONCLUSIONS	The novel basal insulin analog BIL has relative hepatopreferential action and decreased peripheral action , compared with insulin glargine , in healthy subjects .

###24742381
BACKGROUND	The consequences of alcohol dependence are severe and may range from physical disease to neuropsychological deficits in several cognitive domains .
BACKGROUND	Alcohol abuse has also been related to brain dysfunction specifically in the prefrontal cortex .
BACKGROUND	Conventional neuropsychological interventions ( paper-and-pencil cognitive stimulation training ) have a positive effect but are time-consuming , costly , and not motivating for patients .
OBJECTIVE	Our goal was to test the cognitive effects of a novel approach to neuropsychological intervention , using mobile technology and serious games , on patients with alcohol dependence .
METHODS	The trial design consisted of a two-arm study assessing the cognitive outcomes of neuropsychological intervention with mobile serious games ( mHealth ) versus control ( treatment-as-usual with no neuropsychological intervention ) in patients undergoing treatment for alcohol dependence syndrome .
METHODS	Sixty-eight patients were recruited from an alcohol-rehab clinic and randomly assigned to the mHealth ( n = 33 ) or control condition ( n = 35 ) .
METHODS	The intervention on the experimental group consisted of a therapist-assisted cognitive stimulation therapy for 4 weeks on a 2-3 days/week basis .
RESULTS	Fourteen patients dropped out of the study .
RESULTS	The results of the neuropsychological assessments with the remaining 54 patients showed an overall increase ( P < .05 ) of general cognitive abilities , mental flexibility , psychomotor processing speed , and attentional ability in both experimental ( n = 26 ) and control groups ( n = 28 ) .
RESULTS	However , there was a more pronounced improvement ( P = .01 ) specifically in frontal lobe functions from baseline ( mean 13.89 , SE 0.58 ) to follow-up ( mean 15.50 , SE 0.46 ) in the experimental group but not in the control group .
CONCLUSIONS	The overall increase in general cognitive function for both experimental and control groups supports the beneficial role of existing alcohol treatment protocols aimed at minimizing withdrawal symptoms , but the differential improvements observed in frontal lobe functioning supports the use of mobile serious games for neuropsychological stimulation to overcome executive dysfunction in patients with alcohol dependence .
CONCLUSIONS	This trial was negative on two neuropsychological/cognitive tests , and positive on one .
BACKGROUND	ClinicalTrials.gov NCT01942954 ; http://www.clinicaltrials.gov/ct2/show/NCT01942954 .

###25256843
OBJECTIVE	To assess the efficacy of oral transmucosal meloxicam for pain relief in lambs at marking .
METHODS	A blinded , placebo-controlled , randomised , block design field study of 60 Merino lambs aged 7-10 weeks allocated to placebo and meloxicam treatments and studied in two cohorts of 30 .
METHODS	Placebo-treated lambs received 1mL/10kg of drug vehicle and meloxicam-treated lambs received 1mg/kg meloxicam at 10mg/mL .
METHODS	Treatments were administered into the buccal cavity immediately before knife castration and hot-iron tail docking .
METHODS	Lambs were then released into a grassed paddock ( 0.34 ha ) .
METHODS	Time to mother-up was recorded and behaviours were observed every 15min for 8h and again for 45min at 24h .
METHODS	The sequence in which lambs exited the paddock with their mothers was then recorded .
METHODS	Weight change and wound scores were recorded 4 and 7 days after marking .
RESULTS	Meloxicam did not affect mothering-up .
RESULTS	In the 8h following marking , meloxicam led to a 7-fold reduction ( P < 0.001 ) in combined abnormal behaviours ( hunched standing , standing with a stretched posture , walking stiffly ) .
RESULTS	The meloxicam group spent significantly less time in standing postures and tended to spend more time grazing , suckling and in normal lying postures .
RESULTS	At 24h , the meloxicam group spent more time lying and less time standing .
RESULTS	There was no effect of treatments on the sequence in which lambs moved into a fresh paddock or on weight change .
CONCLUSIONS	The buccal meloxicam formulation provided substantial analgesia to lambs on the day of marking .
CONCLUSIONS	Slight benefits were evident the following morning .

###25261549
BACKGROUND	Coronary artery bypass grafting success is limited by vein graft failure ( VGF ) .
BACKGROUND	Understanding the factors associated with VGF may improve patient outcomes .
RESULTS	We examined 1828 participants in the Project of Ex Vivo Vein Graft Engineering via Transfection IV ( PREVENT IV ) trial undergoing protocol-mandated follow-up angiography 12 to 18 months post-coronary artery bypass grafting or earlier clinically driven angiography .
RESULTS	Outcomes included patient - and graft-level angiographic VGF ( 75 % stenosis or occlusion ) .
RESULTS	Variables were selected by using Fast False Selection Rate methodology .
RESULTS	We examined relationships between variables and VGF in patient - and graft-level models by using logistic regression without and with generalized estimating equations .
RESULTS	At 12 to 18 months post-coronary artery bypass grafting , 782 of 1828 ( 42.8 % ) patients had VGF , and 1096 of 4343 ( 25.2 % ) vein grafts had failed .
RESULTS	Demographic and clinical characteristics were similar between patients with and without VGF , although VGF patients had longer surgical times , worse target artery quality , longer graft length , and they more frequently underwent endoscopic vein harvesting .
RESULTS	After multivariable adjustment , longer surgical duration ( odds ratio per 10-minute increase , 1.05 ; 95 % confidence interval , 1.03-1 .07 ) , endoscopic vein harvesting ( odds ratio , 1.41 ; 95 % confidence interval , 1.16-1 .71 ) , poor target artery quality ( odds ratio , 1.43 ; 95 % confidence interval , 1.11-1 .84 ) , and postoperative use of clopidogrel or ticlopidine ( odds ratio , 1.35 ; 95 % confidence interval , 1.07-1 .69 ) were associated with patient-level VGF .
RESULTS	The predicted likelihood of VGF in the graft-level model ranged from 12.1 % to 63.6 % .
CONCLUSIONS	VGF is common and associated with patient and surgical factors .
CONCLUSIONS	These findings may help identify patients with risk factors for VGF and inform the development of interventions to reduce VGF .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00042081 .

###24937535
OBJECTIVE	The insulin secretion/insulin resistance ( IR ) ( disposition ) index ( I/G IR , where is change from baseline , I is insulin , and G is glucose ) is commonly used as a measure of - cell function .
OBJECTIVE	This relationship is curvilinear and becomes linear when log transformed .
OBJECTIVE	I is determined by 2 variables : insulin secretion rate ( ISR ) and metabolic clearance of insulin .
OBJECTIVE	We postulated that the characteristic curvilinear relationship would be lost if plasma C-peptide ( CP ) ( instead of plasma insulin ) was plotted against insulin sensitivity .
METHODS	A total of 441 individuals with impaired glucose tolerance ( IGT ) from ACT NOW received an oral glucose tolerance test and were randomized to pioglitazone or placebo for 2.4 years .
RESULTS	Pioglitazone reduced IGT conversion to diabetes by 72 % ( P < .0001 ) .
RESULTS	I/G vs the Matsuda index of insulin sensitivity showed the characteristic curvilinear relationship .
RESULTS	However , when CP/G or ISR/G was plotted against the Matsuda index , the curvilinear relationship was completely lost .
RESULTS	This discordance was explained by 2 distinct physiologic effects that altered plasma insulin response in opposite directions : 1 ) increased ISR and 2 ) augmented metabolic clearance of insulin .
RESULTS	The net result was a decline in the plasma insulin response to hyperglycemia during the oral glucose tolerance test .
RESULTS	These findings demonstrate a physiologic control mechanism wherein the increase in ISR ensures adequate insulin delivery into the portal circulation to suppress hepatic glucose production while delivering a reduced but sufficient amount of insulin to peripheral tissues to maintain the pioglitazone-mediated improvement in insulin sensitivity without excessive hyperinsulinemia .
CONCLUSIONS	These results demonstrate the validity of the disposition index when relating the plasma insulin response to insulin sensitivity but underscore the pitfall of this index when drawing conclusions about - cell function , because insulin secretion declined despite an increase in the plasma insulin response .

###24996454
OBJECTIVE	The aim of this study is to ascertain the subsequent radiobiological impact of using a consensus guideline target volume delineation atlas .
METHODS	Using a representative case and target volume delineation instructions derived from a proposed IMRT rectal cancer clinical trial , gross tumor volume ( GTV ) and clinical/planning target volumes ( CTV/PTV ) were contoured by 13 physician observers ( Phase 1 ) .
METHODS	The observers were then randomly assigned to follow ( atlas ) or not-follow ( control ) a consensus guideline/atlas for anorectal cancers , and instructed to re-contour the same case ( Phase 2 ) .
RESULTS	The atlas group was found to have increased tumor control probability ( TCP ) after the atlas intervention for both the CTV ( p < 0.0001 ) and PTV1 ( p = 0.0011 ) with decreasing normal tissue complication probability ( NTCP ) for small intestine , while the control group did not .
RESULTS	Additionally , the atlas group had reduced variance in TCP for all target volumes and reduced variance in NTCP for the bowel .
RESULTS	In Phase 2 , the atlas group had increased TCP relative to the control for CTV ( p = 0.03 ) .
CONCLUSIONS	Visual atlas and consensus treatment guideline usage in the development of rectal cancer IMRT treatment plans reduced the inter-observer radiobiological variation , with clinically relevant TCP alteration for CTV and PTV volumes .

###26176036
OBJECTIVE	This study aims to compare the clinical outcomes and costs between endoscopic biliary stenting ( EBS ) and percutaneous transhepatic biliary stenting ( PTBS ) .
METHODS	We randomly assigned 112 patients with unresectable malignant biliary obstruction 2006 and 2011 to receive EBS or PTBS with self-expandable metal stent ( SEMS ) as palliative treatment .
METHODS	PTBS was successfully performed in 55 patients who formed the PTBS group ( failed in 2 patients ) .
METHODS	EBS was successfully performed in 52 patients who formed the EBS group ( failed in 3 patients ) .
METHODS	The effectiveness of biliary drainage , hospital stay , complications , cost , survival time and mortality were compared .
RESULTS	Patients in PTBS group had shorter hospital stay and lower initial and overall expense than the BBS group ( P < 0.05 ) .
RESULTS	There was no significant difference in effectiveness of biliary drainage ( P = 0.9357 ) or survival time between two groups ( P = 0.6733 ) .
RESULTS	Early complications occurred in PTBS group was significantly lower than in EBS group ( 3/55 vs 11/52 , P = 0.0343 ) .
RESULTS	Late complications in the EBS group did not differ significantly from PTBS group ( 7/55 vs 9/52 , P = 0.6922 ) .
RESULTS	The survival curves in the two groups showed no significant difference ( P = 0.5294 ) .
RESULTS	Conclusions : 3 .

###24355439
OBJECTIVE	Rheumatoid arthritis ( RA ) is an inflammatory autoimmune disease in which the gut microbiota is altered .
OBJECTIVE	Probiotics are microorganisms that can normalize gut microbiota ; thus , they may help to alleviate RA symptoms .
OBJECTIVE	The objective of the present clinical trial was to assess the effects of probiotic supplementation on disease activity and inflammatory cytokines in patients with RA .
METHODS	Forty-six patients with RA were assigned into two groups in this randomized , double-blind , placebo-controlled clinical trial .
METHODS	The patients in the probiotic group received a daily capsule that contained a minimum of 10 ( 8 ) colony-forming units of Lactobacillus casei 01 for 8 wk .
METHODS	The placebo group took capsules filled with maltodextrin for the same time period .
METHODS	Questionnaires , anthropometric measurements , and fasting blood samples were collected , and the participants were assessed by a rheumatologist at baseline and at the end of the trial .
RESULTS	Disease activity score was significantly decreased by the intervention , and there was a significant difference between the two groups at the end of the study ( P < 0.01 ) .
RESULTS	Three of the assessed serum proinflammatory cytokines ( tumor necrosis factor - , interleukin-6 , and interleukin-12 ) significantly decreased in the probiotic group ( P < 0.05 ) ; however , serum levels of interleukin-1 were not significantly affected by the probiotic ( P = 0.22 ) .
RESULTS	The serum level of regulatory cytokine ( interleukin-10 ) was increased by the supplementation ( P < 0.05 ) .
RESULTS	The proportion of interleukin-10 to interleukin-12 was significantly increased in the probiotic group as well .
CONCLUSIONS	L. casei 01 supplementation improved the disease activity and inflammatory status of patients with RA .
CONCLUSIONS	Further studies are warranted to confirm these results , and such confirmation may lead to the introduction of probiotics as adjunctive therapy for this population .

###25646337
BACKGROUND	Small birth size , often associated with insufficient maternal nutrition , contributes to a large share of global child undernutrition , morbidity , and mortality .
BACKGROUND	We developed a small-quantity lipid-based nutrient supplement ( SQ-LNS ) to enrich the diets of pregnant women .
OBJECTIVE	The objective was to test a hypothesis that home fortification of pregnant women 's diets with SQ-LNS would increase birth size in an African community .
METHODS	We enrolled 1391 women with uncomplicated pregnancies ( < 20 gestational weeks ) in a randomized controlled trial in Malawi .
METHODS	The women were provided with one daily iron-folic acid ( IFA ) capsule , one capsule containing multiple micronutrients ( MMNs ) , or one 20-g sachet of SQ-LNS ( LNS , containing 118 kcal , protein , carbohydrates , essential fatty acids , and 21 micronutrients ) .
METHODS	Primary outcomes were birth weight and newborn length .
METHODS	Secondary outcomes included newborn weight , head and arm circumference , and pregnancy duration .
METHODS	Analysis was by intention to treat .
RESULTS	The mean SD birth weight and newborn length were 2948 432 , 2964 460 , and 3000 447 g ( P = 0.258 ) and 49.5 2.4 , 49.7 2.2 , and 49.9 2.1 cm ( P = 0.104 ) in the IFA , MMN , and LNS groups , respectively .
RESULTS	For newborn weight-for-age , head circumference , and arm circumference , the point estimate for the mean was also highest in the LNS group , intermediate in the MMN group , and lowest in the IFA group , but except for midupper arm circumference ( P = 0.024 ) , the differences were not statistically significant .
RESULTS	The prevalence of low birth weight ( < 2500 g ) was 12.7 % , 13.5 % , and 12.1 % ( P = 0.856 ) , respectively ; newborn stunting ( length-for-age z score < -2 ) was 19.2 % , 14.0 % , and 14.9 % ( P = 0.130 ) , respectively ; and newborn small head circumference ( head circumference-for-age z score < -2 ) was 5.8 % , 3.0 % , and 3.1 % ( P = 0.099 ) , respectively .
RESULTS	The associations between the intervention and the outcomes were not modified by maternal parity , age , or nutritional status ( P > 0.100 ) .
CONCLUSIONS	The study findings do not support a hypothesis that provision of SQ-LNS to all pregnant women would increase the mean birth size in rural Malawi .
CONCLUSIONS	The trial was registered at clinicaltrials.gov as NCT01239693 .

###24787497
BACKGROUND	Obesity impairs cognition and health-related quality of life ( HRQOL ) in older adults ; however , the appropriate treatment of obese older adults remains controversial .
OBJECTIVE	The objective was to determine the independent and combined effects of weight loss and exercise on cognition , mood , and HRQOL in obese older adults .
METHODS	One hundred seven frail , obese older adults were randomly assigned to a control , weight-management ( diet ) , exercise , or weight-management-plus-exercise ( diet-exercise ) group for 1 y.
METHODS	In this secondary analysis , main outcomes were Modified Mini-Mental State Examination ( 3MS ) and total Impact of Weight on Quality of Life-Lite ( IWQOL ) scores .
METHODS	Other outcomes included Word Fluency Test , Trail Making Test Parts A and B , and Geriatric Depression Scale ( GDS ) scores .
RESULTS	Scores on the 3MS improved more in the diet ( mean SE : 1.7 0.4 ) , exercise ( 2.8 0.4 ) , and diet-exercise ( 2.9 0.4 ) groups than in the control group ( 0.1 0.4 ) ( between-group P = 0.0001-0 .04 ) ; scores in the diet-exercise group improved more than in the diet group but not more than in the exercise group .
RESULTS	Scores on the Word Fluency Test improved more in the exercise ( 4.1 0.8 ) and diet-exercise ( 4.2 0.7 ) groups than in the control group ( -0.8 0.8 ; both P = 0.001 ) .
RESULTS	For the Trail Making Test Part A , scores in the diet-exercise group ( -11.8 1.9 ) improved more than in the control group ( -0.8 1.9 ) ( P = 0.001 ) ; a similar finding was observed for the Trail Making Test Part B. Scores on the IWQOL improved more in the diet ( 7.6 1.6 ) , exercise ( 10.1 1.6 ) , and diet-exercise ( 14.0 1.4 ) groups than in the control group ( 0.3 1.6 ) ( P = 0.0001-0 .03 ) ; scores in the diet-exercise group improved more than in the diet group but not more than in the exercise group .
RESULTS	In the diet-exercise group , peak oxygen consumption and strength changes were independent predictors of 3MS changes ; weight and strength changes were independent predictors of IWQOL changes .
RESULTS	GDS scores did not change .
CONCLUSIONS	Weight loss and exercise each improve cognition and HRQOL , but their combination may provide benefits similar to exercise alone .
CONCLUSIONS	These findings could inform practice guidelines with regard to optimal treatment strategies for obese older adults .
CONCLUSIONS	This trial was registered atclinicaltrials.govas NCT00146107 .

###24567456
OBJECTIVE	The purpose of this study was to determine whether contrast-enhanced sonography can improve the ability to differentiate branch duct intraductal mucinous neoplasms from serous cystadenomas of the pancreas compared to conventional ( unenhanced ) sonography alone .
METHODS	Between March 2008 and May 2012 , there were 20 patients with branch duct intraductal mucinous neoplasms and 25 with serous cystadenomas in our institute , for whom preoperative conventional and contrast-enhanced sonographic results were available .
METHODS	The final diagnosis was obtained by histopathology .
METHODS	Various conventional and contrast-enhanced sonographic characteristics were retrospectively evaluated by 2 radiologists in consensus .
METHODS	A receiver operating characteristic curve analysis was used to evaluate the diagnostic value of conventional and contrast-enhanced sonography for discriminating between the two entities .
RESULTS	Three conventional sonographic characteristics ( microcysts , cysts with internal echoes , and main pancreatic duct dilatation ) and 2 contrast-enhanced sonographic characteristics ( communication between the lesion and main pancreatic duct and enhancement of mural nodules ) significantly improved the ability to differentiate branch duct intraductal mucinous neoplasms from serous cystadenomas .
RESULTS	The area under the receiver operating characteristic curve increased from 0.691 with conventional sonography to 0.859 with combined contrast-enhanced and conventional ultrasonography ( P = .043 ) .
CONCLUSIONS	In this series of patients , the addition of contrast-enhanced sonography to conventional sonography improved the ability to differentiate branch duct intraductal mucinous neoplasms from serous cystadenomas .

###24655537
OBJECTIVE	To test the hypothesis that an initial fraction of inspired oxygen ( FiO2 ) of 30 % during resuscitation of preterm infants results in less oxidative stress and is associated with improved clinical outcomes compared with an FiO2 of 65 % .
METHODS	Preterm infants of gestational age < 32 weeks ( n = 193 ) were randomized to start resuscitation with either 30 % oxygen ( low-oxygen group ) or 65 % oxygen ( high-oxygen group ) , after which the FiO2 was adjusted based on oxygen saturation values .
METHODS	The primary outcome was bronchopulmonary dysplasia ( BPD ) assessed at 36 weeks postmenstrual age .
METHODS	Secondary outcomes included major neonatal illnesses and markers of oxidative stress .
RESULTS	The median gestational age of included infants was 28 ( 6 ) / 7 weeks ( IQR , 26 ( 5 ) / 7-30 ( 3 ) / 7 weeks ) .
RESULTS	The incidence of BPD was not significantly different between the low-oxygen and high-oxygen groups ( 24 % vs. 17 % ; P = .15 ) .
RESULTS	The FiO2 in both groups was adjusted to a mean of 40 % by 7 minutes in the low-oxygen group and by 11 minutes in the high-oxygen group .
RESULTS	No differences in markers of oxidative stress were noted between groups .
CONCLUSIONS	Initial supplementation of preterm infants with 30 % oxygen during the fetal-to-neonatal transition is as safe as 65 % oxygen , with no differences in oxidative stress markers or BPD .

###24256079
OBJECTIVE	To compare immediate surgery to scaling and root planing ( SRP ) in the treatment of advanced periodontal disease focusing on the prevalence of residual sites and cost-effectiveness ( 1 ) ; to evaluate the adjunctive effects of azithromycin in a second treatment phase ( 2 ) .
METHODS	Thirty-nine patients ( 18 males , 21 females ; mean age : 54.6 ) received oral hygiene instructions and were randomly allocated to surgery ( n = 19 ) or SRP ( n = 20 ) .
METHODS	Patients with residual pockets ( 6mm ) at 6months received re-debridement of these sites and systemic azithromycin .
METHODS	Treatment groups were followed up to 12months and evaluated in terms of clinical response parameters and cost-effectiveness .
METHODS	Chair-time was used to assess the financial impact of treatment .
RESULTS	Both treatment arms were equally effective in terms of clinical outcome demonstrating less than 1 % residual pockets at 12months .
RESULTS	Surgery imposed an extra 746 Euro on the patient up to 6months when compared to SRP .
RESULTS	At 12months , 46 Euro of this amount could be offset as a result of a reduced need for supportive care .
RESULTS	Only 6 patients in the surgery group needed systemic antibiotics , whereas 14 patients in the SRP needed such additional treatment .
CONCLUSIONS	Although 700 Euro could be saved on average by performing SRP instead of surgery , the latter significantly reduced the need for supportive care and systemic antibiotics .

###24874344
BACKGROUND	Elective interval appendectomy ( IA ) is traditionally advocated for the management of appendiceal mass ( AM ) in children .
BACKGROUND	Surgeons have debated the evidence and ` risks ' vs. ` benefits ' to support IA .
BACKGROUND	There are currently no randomised controlled trials and guiding best practice and financial costings for IA are lacking .
BACKGROUND	We herein report clinical outcomes , patient benefits and tariff charges linked with the provision of IA at a regional UK paediatric surgical centre .
METHODS	Hospital case records of patients with AM were identified using pathology records and hospital admission codes during a 15-year period ( 1997-2011 ) .
METHODS	Tariff costs ( Sterling ) were calculated for all admissions during the era 2007-2011 .
RESULTS	69 children were admitted with AM ( 61 % female , median age 10.5 years , range 2.1-16 years ) .
RESULTS	Median initial hospital stay with resolution of symptoms was 8 days ( range 3-14 days ) .
RESULTS	61 children ( 88 % ) had elective IA ( median interval 76 days , range 29-230 days ) .
RESULTS	Eight ( 12 % ) patients required emergency readmission for early appendectomy ( median interval 21 days , range 6-51 days ) .
RESULTS	Hospital stay for emergency readmission appendectomy in these children was significantly longer than IA ( median 6 vs. 3 days , p < 0.01 ) .
RESULTS	Laparoscopic appendectomy vs. ` open ' appendectomy was associated with shorter length of stay in the IA cohort ( median 3 vs. 2 days p < 0.01 ) .
RESULTS	No intra-operative morbidity was recorded in the study with only a single case developing a post-operative wound infection .
RESULTS	Median cost for IA was 1,936 .
RESULTS	Costings were higher in the emergency appendectomy group-2 ,171 vs. 1,936 ; p = 0.09 , NS .
CONCLUSIONS	Only 12 % of children at this centre develop recurrent appendicitis after primary admission with AM .
CONCLUSIONS	Interval and emergency appendectomy were associated with low morbidity .
CONCLUSIONS	Parents should be informed that IA may be ` non essential ' surgery .
CONCLUSIONS	Paediatric surgeons not routinely advocating IA can potentially save the NHS 1,936 per patient .
CONCLUSIONS	Future randomised studies are warranted to confirm or refute these findings .

###25095833
OBJECTIVE	This in situ study assessed the effects of adhesive systems containing or not fluoride and/or the antibacterial monomer 12-methacryloyloxydodecylpyridinium bromide ( MDPB ) on the microbiological composition of dental biofilm and enamel demineralization .
METHODS	During two phases of 14 days , ten volunteers wore intraoral palatal appliances containing two slabs of human enamel according to a double-blind , crossover design .
METHODS	The slabs were randomly restored using a composite resin and one of the following adhesive systems : All-Bond SE ( TM ) ( self-etch , fluoride/MDPB free adhesive , AB ) and Clearfl Protect Bond ( self-etch containing fluoride and MDPB adhesive , CB ) .
METHODS	The biofilm formed on the slabs was analyzed with regard to total and mutans streptococci and lactobacilli counts .
METHODS	Demineralization represented by integrated area of hardness lesion depth Delta S ( S ) was determined on enamel by analysis of cross-sectional microhardness , at 20 and 70 m from the restoration margin .
METHODS	Data were analyzed by ANOVA .
RESULTS	No statistically significant difference was found either in enamel demineralization or in the microbiological composition of dental biofilm .
CONCLUSIONS	All adhesive systems containing or not fluoride and/or MDPB tested were unable to inhibit secondary caries in the in situ model used in the present research .

###25284993
BACKGROUND	This pilot study compared the effects of lexical-semantic stimulation through telecommunication technology ( LSS-tele ) with in-person LSS ( LSS-direct ) and unstructured cognitive treatment ( UCS ) in patients with early Alzheimer 's disease .
METHODS	Twenty-seven patients with Alzheimer 's disease in the very early stage ( Mini-Mental State Examination [ MMSE ] > 26/30 ) were divided into three groups : seven patients received LSS-tele treatment , ten received standard LSS-direct intervention , and ten participants underwent UCS as control condition .
METHODS	Intervention treatments consisted of two weekly sessions of LSS ( through teleconference or face to face depending on group assignment ) or UCS exercises administered to small groups throughout a 3-month period .
METHODS	The main outcome measures were changes of global cognitive performance , language abilities , and memory function .
METHODS	Secondary outcome measures were changes in attention , working memory , executive functions , and visual-spatial abilities tests .
RESULTS	The mean MMSE score improved significantly in LSS-tele and LSS-direct treatments ; LSS-tele improved language abilities , both phonemic and semantic , and stabilized delayed verbal episodic memory with respect to an improved performance after the LSS-direct intervention and to a memory decline observed in the control group .
RESULTS	Improvement was not achieved in any neuropsychological test score after UCS .
CONCLUSIONS	Clinical application of telecommunication technology to cognitive rehabilitation of elderly patients with neurodegenerative cognitive impairment is feasible and may improve global cognitive performance .
CONCLUSIONS	Technical aspects to ameliorate efficacy of delivery may further improve its impact on domain-specific cognitive abilities .

###24664788
BACKGROUND	Activation of TRPM8 and TRPA1 receptors generates cold and cold pain sensations , respectively , and is presumably important in clinical pain manifestations , such as cold hyperalgesia .
BACKGROUND	This study investigated the interaction between TRPM8 and TRPA1 receptors through stimulation of glabrous human skin ( volar forearm ) by topical administration of 40 % L-menthol and 10 % trans-cinnamaldehyde ( CA ) , individually and in combination .
METHODS	Sensory manifestations were assessed in 10 healthy volunteers via a platform of 11 quantitative sensory ( thermal and mechanical stimuli ) and vasomotor tests ( skin temperature , perfusion and axon-reflex-flare ) in a double-blinded randomized crossover design .
RESULTS	Cold pain threshold was increased ( p < 0.01 , cold allodynia ) by L-menthol alone and L-menthol + CA in combination but unaffected by CA .
RESULTS	Mechanical pain threshold was significantly decreased ( mechanical hyperalgesia ) by all three substances ( p < 0.01 ) , with a significant intergroup difference found between CA alone and the less decreased L-menthol + CA ( p < 0.05 ) .
RESULTS	Application of CA alone and L-menthol + CA in combination showed an increase in skin temperature and perfusion significantly larger than that induced by L-menthol alone ( p < 0.05 ) .
RESULTS	An axon-reflex-flare was present after CA administration , but was significantly reduced upon addition of L-menthol ( p < 0.01 ) .
CONCLUSIONS	This study elucidates the potential of L-menthol as a counter-irritant to secondary neurogenic inflammation and provides evidence of an intricate interplay between cold receptors TRPA1 and TRPM8 , warranting further investigation of the neural coding of cold pain perception .

###24881859
BACKGROUND	The Placement of Aortic Transcatheter Valves ( PARTNER ) trial reported a reduced rate of mortality in patients with previous coronary bypass grafting ( CABG ) operation who received surgical aortic valve replacement ( SAVR ) in comparison with transcatheter aortic valve replacement ( TAVR ) .
BACKGROUND	We sought to further evaluate these groups .
METHODS	We reviewed the database of the 699 patients enrolled in the PARTNER trial .
METHODS	The cohort for this study consisted of 288 patients ( 41.2 % ) who had a history of CABG operation before enrollment in the PARTNER trial .
METHODS	All patients were followed up for 2 years .
RESULTS	The mean age was 81.56.6 years , and 231 patients ( 80.2 % ) were men .
RESULTS	The preoperative characteristics were similar in 140 patients ( 48.6 % ) who received SAVR and 148 ( 51.4 % ) who received TAVR .
RESULTS	There were no differences between the two groups with respect to the operative outcomes of death , stroke , and myocardial infarction , but the TAVR patients experienced more paravalvular regurgitation ( p < 0.0001 ) .
RESULTS	At 2 years , there was a trend toward greater all-cause mortality in the TAVR patients ( hazard ratio [ HR ] 1.53 ; 95 % confidence interval [ CI ] : 0.99 , 2.35 ; p = 0.052 ) .
RESULTS	Furthermore , the TAVR patients had more repeated hospitalization ( HR 1.75 ; 95 % CI : 0.99 , 3.07 ; p = 0.05 ) , death of any cause or repeated hospitalization ( HR 1.52 ; 95 % CI : 1.06 , 2.19 ; p = 0.02 ) , and death of any cause or stroke ( HR 1.51 ; 95 % CI : 1.00 , 2.27 ; p = 0.05 ) .
CONCLUSIONS	The 2-year follow-up of patients with a history of previous CABG operation in the PARTNER trial demonstrated improved outcomes with SAVR in comparison with TAVR .
CONCLUSIONS	Further longitudinal assessment is necessary to corroborate these findings and to understand the possible causes .

###24547606
OBJECTIVE	To determine influenza ( flu ) vaccination status among the mentally ill population and identify factors associated with vaccination status .
METHODS	A non-interventional , cross-sectional study was conducted .
METHODS	A self-administered survey to investigate the vaccination status and perceptions related to flu vaccine was administered between October 2011-January 2012 in an outpatient psychiatry clinic that served the indigent , severely mentally ill population of Alabama .
METHODS	All statistical analyses were based upon a significance level of 0.05 .
RESULTS	Of the 736 patients invited , 302 participated ( 41 % ) .
RESULTS	Only 28.4 % were vaccinated in 2010-2011 and 24.2 % had been vaccinated at the time of the survey for 2011-2012 .
RESULTS	Respondents who had private health insurance , received a recommendation from healthcare providers , and who perceived a greater degree of vaccine effectiveness were more likely to obtain flu vaccination while respondents who had education beyond high school and were more in agreement that they can get the flu from the vaccine were less likely to obtain flu vaccination .
RESULTS	All of the above factors accounted for 26.7 % of vaccination decisions .
CONCLUSIONS	The flu vaccination rate among this study 's population was lower than the general population .
CONCLUSIONS	Interventions targeting the above factors should help increase vaccination rates among the mentally ill population .

###25261353
OBJECTIVE	To compare two embryo grouping strategies .
METHODS	Retrospective time-course analysis in two different centres .
METHODS	Two culture protocols were used at the zygote stage : `` Random Group '' in which zygotes were randomly grouped and `` Definite Group '' in which zygotes were grouped based on pronuclear pattern .
METHODS	Embryo culture was extended to blastocyst stage .
METHODS	Primary and secondary outcomes were respectively the blastulation rate and the cumulative clinical pregnancy and implantation rates .
RESULTS	A similar blastulation rate [ 42 and 41 % day ( 5 +6 ) blastocysts ] was obtained in the two groups .
RESULTS	Conversely , after adjusting for baseline and cycle variables , cumulative pregnancy [ adjusted Odds Ratio = 2.10 ( 95 % CI : 1.08-4 .07 ) ] and implantation [ adjusted Odds Ratio = 1.78 ( 95 % CI : 1.06-2 .97 ) ] rates were significantly higher in the `` Random Group '' compared to the `` Definite Group '' .
CONCLUSIONS	Two strategies of group culture gave similar results in terms of blastulation rate but the random grouping of zygotes improves pregnancy and implantation rates in IVF-cycles .

###24677417
BACKGROUND	Endogenous pain modulation has been studied with the conditioned pain modulation ( CPM ) paradigm with large differences in the magnitude of the CPM effect .
BACKGROUND	We hypothesized that differences in CPM effects might be associated with differences in blood pressure responses to the conditioning stimulus when comparing the CPM effects using two different conditioning stimuli .
METHODS	A single-blind repeated-measures design with block-randomization was applied on 25 healthy male subjects .
METHODS	The test stimulus ( TS ; tonic heat pain for 120s ) was first presented alone , thereafter in parallel with a conditioning stimulus ( CS ) .
METHODS	Conditioning stimuli were either a cold pressor test ( CPT ) or equally painful ischaemic muscle pain ( ISC ) , both lasting 120s .
METHODS	Finger blood pressure and heart rate were recorded continuously .
METHODS	Data were analysed in a linear mixed model framework with CS type ( CPT or ISC ) and conditioning ( TS or TS+CS ) as independent factors .
RESULTS	An inhibitory CPM effect was found for both types of conditioning ( p < 0.001 ) .
RESULTS	The CPM effect was larger during CPT conditioning compared with ISC conditioning ( p = 0.001 ) .
RESULTS	No association with the concomitant cardiovascular response ( blood pressure and heart rate ) was found ( p > 0.34 ) .
CONCLUSIONS	Cold pressor pain CS induces larger CPM effects than ischaemic pain CS .
CONCLUSIONS	The larger CPM effect is , however , not associated with a larger blood pressure response .
CONCLUSIONS	Other factors related to the CS should be investigated to understand why different CS modalities give different CPM effects .

###25693987
BACKGROUND	A principal justification for the use of high-fidelity ( HF ) simulation is that , because it is closer to reality , students will be more motivated to learn and , consequently , will be better able to transfer their learning to real patients .
BACKGROUND	However , the increased authenticity is accompanied by greater complexity , which may reduce learning , and variability in the presentation of a condition on an HF simulator is typically restricted .
OBJECTIVE	This study was conducted to explore the effectiveness of HF and low-fidelity ( LF ) simulation for learning within the clinical education and practice domains of cardiac and respiratory auscultation and physical assessment skills .
METHODS	Senior-level nursing students were randomised to HF and LF instruction groups or to a control group .
METHODS	Primary outcome measures included LF ( digital sounds on a computer ) and HF ( human patient simulator ) auscultation tests of cardiac and respiratory sounds , as well as observer-rated performances in simulated clinical scenarios .
RESULTS	On the LF auscultation test , the LF group consistently demonstrated performance comparable or superior to that of the HF group , and both were superior to the performance of the control group .
RESULTS	For both HF outcome measures , there was no significant difference in performance between the HF and LF instruction groups .
CONCLUSIONS	The results from this study suggest that highly contextualised learning environments may not be uniformly advantageous for instruction and may lead to ineffective learning by increasing extraneous cognitive load in novice learners .

###25574795
OBJECTIVE	Research in acute illness often requires an exception from informed consent .
OBJECTIVE	Few studies have assessed the views of patients enrolled in exception from informed consent trials .
OBJECTIVE	This study was designed to assess the views of patients and their surrogates of exception from informed consent enrollment within the context of a randomized , placebo-controlled trial of an investigational agent for traumatic brain injury .
METHODS	Interactive interview study .
METHODS	Nested within the Progesterone for the Treatment of Traumatic Brain Injury trial , a Phase III randomized controlled trial in acute traumatic brain injury .
METHODS	Patients and surrogates ( for patients incapable of being interviewed ) enrolled in Progesterone for the Treatment of Traumatic Brain Injury under exception from informed consent at 12 sites .
METHODS	None .
RESULTS	Interviews focused on respondents ' acceptance of exception from informed consent enrollment in Progesterone for the Treatment of Traumatic Brain Injury , use of placebo and randomization , understanding of major study elements , and views regarding regulatory protections .
RESULTS	Descriptive statistical analysis was performed ; textual data were analyzed thematically .
RESULTS	Eighty-five individuals were interviewed .
RESULTS	Eighty-four percent had positive attitudes toward Progesterone for the Treatment of Traumatic Brain Injury inclusion .
RESULTS	Seventy-eight percent found their inclusion under exception from informed consent acceptable , and 72 % found use of exception from informed consent in Progesterone for the Treatment of Traumatic Brain Injury acceptable in general .
RESULTS	Only two respondents clearly disagreed with both personal and general exception from informed consent enrollment .
RESULTS	The most common concerns ( 26 % ) related to absence of consent .
RESULTS	Eighty percent and 92 % were accepting of placebo use and randomization , respectively .
RESULTS	Although there were few black respondents ( n = 11 ) , they were less accepting of personal exception from informed consent enrollment than white respondents ( 55 % vs 83 % ; p = 0.0494 ) .
CONCLUSIONS	Acceptance of exception from informed consent in this placebo-controlled trial of an investigational agent was high and exceeded acceptance among community consultation participants .
CONCLUSIONS	Exception from informed consent enrollment appears generally consistent with patients ' preferences .

###24687965
OBJECTIVE	Fluoroscopy is the routine method for localizing left ventricular ( LV ) and right ventricular ( RV ) lead positions in cardiac resynchronization therapy ( CRT ) .
OBJECTIVE	However , the ability of fluoroscopy to determine lead positions in a standard ventricular segmentation is unknown .
OBJECTIVE	We aimed to evaluate the accuracy and reproducibility of fluoroscopy to determine LV and RV lead positions in CRT when compared with cardiac computed tomography ( CT ) .
RESULTS	Fifty-nine patients undergoing CRT were included .
RESULTS	Bi-plane fluoroscopy and cardiac CT were evaluated in all patients .
RESULTS	Pacing lead positions were assessed in a standard LV 16-segment model and in a simplistic RV 8-segment model .
RESULTS	Four patients with LV lead displacement were excluded from the agreement analysis of LV lead position .
RESULTS	Agreement of LV lead position between fluoroscopy and cardiac CT was observed in 19 ( 35 % ) patients with fluoroscopy demonstrating a 1-segment and 2-segment error in 30 ( 55 % ) and 6 ( 11 % ) patients , respectively .
RESULTS	Agreement of RV lead position was found in 13 ( 22 % ) patients with fluoroscopy showing a 1-segment and 2-segment error in 28 ( 47 % ) and 18 ( 31 % ) patients , respectively .
RESULTS	The interobserver agreement on LV and RV lead positions was poor for fluoroscopy ( kappa 0.20 and 0.23 , respectively ) and excellent for cardiac CT ( kappa 0.87 and 0.85 , respectively ) .
CONCLUSIONS	Fluoroscopy is inaccurate and modestly reproducible when assessing LV and RV lead positions in a standard ventricular segmentation when compared with cardiac CT. .
CONCLUSIONS	Cardiac CT should be applied to determine the exact pacing site in future research evaluating the optimal pacing lead position in CRT .

###25341903
OBJECTIVE	To observe the safety and efficacy of early oral enteral nutrition after colorectal cancer operation .
METHODS	A total of 88 colorectal cancer patients in our department from March 2013 to December 2013 were prospectively enrolled in the study and randomly divided into early enteral nutrition group ( 43 cases , receiving early water and enteral nutrition after operation ) and early fasting group ( 45 cases , receiving conventional postoperative care protocol ) based on the random number table .
METHODS	The postoperative recovery , complication morbidity , nutritional status and stress were compared between the two groups .
RESULTS	Compared to early fasting group , patients in early enteral nutrition group had a significantly shorter duration of postoperative fever [ ( 53.75.9 ) h vs. ( 64.55.8 ) h , P < 0.01 ] , a shorter interval to flatus [ ( 57.58.2 ) h vs. ( 71.87.2 ) h , P < 0.01 ] , a shorter hospital stay [ ( 6.91.4 ) d vs. ( 8.51.9 ) d , P < 0.01 ] and lower medical cost [ ( 41 8683168 ) Yuan vs. ( 45 9503714 ) Yuan , P < 0.01 ] .
RESULTS	There was no significant difference in complication morbidity between the two groups [ 18.6 % ( 8/43 ) vs. 22.2 % ( 10/45 ) , P > 0.05 ] .
RESULTS	The albumin , prealbumin , and retinol binding protein on the third and seventh postoperative days were significantly higher in early oral enteral nutrition group ( P < 0.05 ) , while the rest energy expense ( REE ) and lnHOMA-IR were significantly lower as compared to early fasting group ( all P < 0.05 ) .
CONCLUSIONS	Early oral enteral nutrition after colorectal cancer operation is safe and effective , which is a natural route of nutrition and can reduce the stress response related to surgery , improve postoperative patients ' nutritional status and accelerate rehabilitation .

###24341527
BACKGROUND	Enhanced reduction of multinodular goiter ( MNG ) can be achieved by stimulation with recombinant human thyrotropin ( rhTSH ) before radioiodine ( ( 131 ) I ) therapy .
BACKGROUND	The objective was to compare the long-term efficacy and safety of two low doses of modified release rhTSH ( MRrhTSH ) in combination with ( 131 ) I therapy .
METHODS	In this phase II , single-blinded , placebo-controlled study , 95 patients ( 57.2 9.6 years old , 85 % women , 83 % Caucasians ) with MNG ( median size 96.0 mL ; range 31.9-242 .2 mL ) were randomized to receive placebo ( n = 32 ) , 0.01 mg MRrhTSH ( n = 30 ) , or 0.03 mg MRrhTSH ( n = 33 ) 24 hours before a calculated ( 131 ) I activity .
METHODS	Thyroid volume ( TV ) and smallest cross-sectional area of trachea ( SCAT ) were measured ( by computed tomography scan ) at baseline , six months , and 36 months .
METHODS	Thyroid function and quality of life ( QoL ) was evaluated at three-month and yearly intervals respectively .
RESULTS	At six months , TV reduction was enhanced in the 0.03 mg MRrhTSH group ( 32.9 % vs. 23.1 % in the placebo group ; p = 0.03 ) but not in the 0.01 mg MRrhTSH group .
RESULTS	At 36 months , the mean percent TV reduction from baseline was 44 12.7 % ( SD ) in the placebo group , 41 21.0 % in the 0.01 mg MRrhTSH group , and 53 18.6 % in the 0.03 mg MRrhTSH group , with no statistically significant differences among the groups , p = 0.105 .
RESULTS	In the 0.03 mg MRrhTSH group , the subset of patients with basal ( 131 ) I uptake < 20 % had a 24 % greater TV reduction at 36 months than the corresponding subset of patients in the placebo group ( p = 0.01 ) .
RESULTS	At 36 months , the largest relative increase in SCAT was observed in the 0.03 mg MRrhTSH group ( 13.4 23.2 % ) , but this was not statistically different from the increases observed in the placebo or the 0.01 mg MRrhTSH group ( p = 0.15 ) .
RESULTS	Goiter-related symptoms were reduced and QoL improved , without any enhanced benefit from using MRrhTSH .
RESULTS	At three years , the prevalence of permanent hypothyroidism was 13 % , 33 % , and 45 % in the placebo , 0.01 mg , and 0.03 mg MRrhTSH groups respectively .
RESULTS	The overall safety profile of the study was favorable .
CONCLUSIONS	When used as adjuvant to ( 131 ) I , enhanced MNG reduction could not be demonstrated with MRrhTSH doses 0.03 mg , indicating that the lower threshold for efficacy is around this level .

###24943088
BACKGROUND	Intervention of medical clowns ( MC ) during various medical procedures performed in children has been used to relieve anxiety and pain .
BACKGROUND	Their role in allergy skin testing has never been evaluated .
OBJECTIVE	To evaluate whether MC can diminish pain and anxiety perceived by children undergoing allergy skin prick tests ( SPT ) .
METHODS	In a prospective , randomized , controlled , and blinded study , children undergoing SPT were or were not accompanied by MC .
METHODS	All parents and children 8years completed the State-Trait Anxiety Inventory ( STAI ) before and after SPT .
METHODS	Videotapes recorded during the procedure were scored for anxiety ( m-YPAS ) for all children and for pain ( FLACC ) for children 2-7years old by a psychologist who was unaware of the MC 's presence .
METHODS	After SPT , children 8years completed a visual analog score ( VAS ) for pain .
RESULTS	Ninety-one children ( mean age 8.2 years , M/F = 54/37 ) were recruited of whom 45 were accompanied by clowns .
RESULTS	A significant reduction in state-STAI was found in the clowns group , in both parents and children , when compared with the regular group ( 26.96.6 and 32.310.0 ; P = 0.004 , and 27.14.2 and 34.37.6 ; P = 0.002 , respectively ) .
RESULTS	Both m-YPAS and FLACC were reduced in the clowns group compared with the regular one .
RESULTS	In the clowns group , m-YPAS positively correlated with both VAS and FLACC ( P = 0.000 and 0.002 , respectively ) .
RESULTS	m-YPAS was positively correlated with FLACC in the regular group ( P = 0.000 ) .
CONCLUSIONS	Medical clowns significantly decrease the level of anxiety perceived by both children undergoing allergy SPT and their parents , as well as the pain perceived by young children .

###24589090
BACKGROUND	An immune-enhancing diet has been used to alter eicosanoid synthesis , cytokine production , and immune function in an attempt to limit the undesired immune reactions after injury from surgery .
BACKGROUND	This prospective randomized study was designed to investigate the effect of preoperative immunonutrition on operative complications , and the participation of prostaglandin E2 ( PGE2 ) on T-cell differentiation in patients undergoing a severely stressful surgery .
METHODS	The enrolled patients who were scheduled to undergo pancreatoduodenectomy were randomized into two groups .
METHODS	Patients in the immunonutrition group ( n = 25 ) received oral supplementation containing arginine , -3 fatty acids , and RNA for 5 days before the procedure in addition to a 50 % reduction in the amount of regular food .
METHODS	Patients in the control group ( n = 25 ) received no artificial nutrition and were allowed to consume regular food before surgery .
METHODS	All patients received early postoperative enteral infusion of a standard formula intended to provide 25 kcal/kg/day .
METHODS	The primary endpoint was the rate of infectious complications ; the secondary endpoint was immune responses .
METHODS	This study is registered with ClinicalTrials.gov ( NCT01256034 ) .
RESULTS	Infectious complication rate and severity of complications ( Clavien-Dindo classification ) were lesser in the immunonutrition group than in the control group .
RESULTS	mRNA expression levels of T-bet were greater in the immunonutrition group than in the control group ( P < .05 ) .
RESULTS	Serum eicosapentaenoic acid and eicosapentaenoic acid/arachidonic acid ratios were greater in the immunonutrition group than in the control group ( P < .05 ) .
RESULTS	The levels of plasma PGE2 were lesser in the immunonutrition group than in the control group ( P < .05 ) .
CONCLUSIONS	Preoperative immunonutrition modulates PGE2 production and T-cell differentiation and may protect against the aggravation of operative complications in patients undergoing pancreatoduodenectomy .

###24349492
OBJECTIVE	To determine if sleep talkers with REM sleep behavior disorder ( RBD ) would utter during REM sleep sentences learned before sleep , and to evaluate their verbal memory consolidation during sleep .
METHODS	Eighteen patients with RBD and 10 controls performed two verbal memory tasks ( 16 words from the Free and Cued Selective Reminding Test and a 220-263 word long modified Story Recall Test ) in the evening , followed by nocturnal video-polysomnography and morning recall ( night-time consolidation ) .
METHODS	In 9 patients with RBD , daytime consolidation ( morning learning/recall , evening recall ) was also evaluated with the modified Story Recall Test in a cross-over order .
METHODS	Two RBD patients with dementia were studied separately .
METHODS	Sleep talking was recorded using video-polysomnography , and the utterances were compared to the studied texts by two external judges .
RESULTS	Sleep-related verbal memory consolidation was maintained in patients with RBD ( +2436 % words ) as in controls ( +918 % , p = 0.3 ) .
RESULTS	The two demented patients with RBD also exhibited excellent nighttime consolidation .
RESULTS	The post-sleep performance was unrelated to the sleep measures ( including continuity , stages , fragmentation and apnea-hypopnea index ) .
RESULTS	Daytime consolidation ( -919 % ) was worse than night-time consolidation ( +2945 % , p = 0.03 ) in the subgroup of 9 patients with RBD .
RESULTS	Eleven patients with RBD spoke during REM sleep and pronounced a median of 20 words , which represented 0.0003 % of sleep with spoken language .
RESULTS	A single patient uttered a sentence that was judged to be semantically ( but not literally ) related to the text learned before sleep .
CONCLUSIONS	Verbal declarative memory normally consolidates during sleep in patients with RBD .
CONCLUSIONS	The incorporation of learned material within REM sleep-associated sleep talking in one patient ( unbeknownst to himself ) at the semantic level suggests a replay at a highly cognitive creative level .

###24261771
BACKGROUND	This is a randomized comparative study of the efficacy of celecoxib and loxoprofen in patients with frozen shoulder ( scapulohumeral periarthritis ) .
METHODS	Patients with frozen shoulder who presented with pain as the symptom were divided at random into a celecoxib treatment group ( 100 mg/dose , twice daily ; n = 37 ) and a loxoprofen treatment group ( 60 mg/dose , 3 times daily ; n = 33 ) .
METHODS	Medication was continued for 1-2 weeks in each group .
RESULTS	Each patient was asked to rate the pain on a visual analog scale ( score 0-5 ) .
RESULTS	This score significantly improved ( indicating marked alleviation of pain ) in both the celecoxib group ( from 3.41 0.86 before treatment to 2.30 1.02 after treatment ) and the loxoprofen group ( from 3.73 0.67 before treatment to 2.76 0.96 after treatment ) .
RESULTS	In the analysis of disappearance of pain , the percentage of patients showing disappearance of nocturnal pain was significantly higher in the celecoxib group ( 71.4 % ) than in the loxoprofen group ( 36.8 % ) .
CONCLUSIONS	The results confirm that celecoxib is comparable to loxoprofen in terms of analgesic efficacy in patients with frozen shoulder .
CONCLUSIONS	Among other findings , we report that celecoxib was more effective for nocturnal pain than loxoprofen .

###25330017
OBJECTIVE	Prescription opioid dependence is increasing and creates a significant public health burden , but primary care physicians lack evidence-based guidelines to decide between tapering doses followed by discontinuation of buprenorphine hydrochloride and naloxone hydrochloride therapy ( hereinafter referred to as buprenorphine therapy ) or ongoing maintenance therapy .
OBJECTIVE	To determine the efficacy of buprenorphine taper vs ongoing maintenance therapy in primary care-based treatment for prescription opioid dependence .
METHODS	We conducted a 14-week randomized clinical trial that enrolled 113 patients with prescription opioid dependence from February 17 , 2009 , through February 1 , 2013 , in a single primary care site .
METHODS	Patients were randomized to buprenorphine taper ( taper condition ) or ongoing buprenorphine maintenance therapy ( maintenance condition ) .
METHODS	The buprenorphine taper was initiated after 6 weeks of stabilization , lasted for 3 weeks , and included medications for opioid withdrawal , after which patients were offered naltrexone treatment .
METHODS	The maintenance group received ongoing buprenorphine therapy .
METHODS	All patients received physician and nurse support and drug counseling .
METHODS	Illicit opioid use via results of urinanalysis and patient report , treatment retention , and reinitiation of buprenorphine therapy ( taper group only ) .
RESULTS	During the trial , the mean percentage of urine samples negative for opioids was lower for patients in the taper group ( 35.2 % [ 95 % CI , 26.2 % -44.2 % ] ) compared with those in the maintenance group ( 53.2 % [ 95 % CI , 44.3 % -62.0 % ] ) .
RESULTS	Patients in the taper group reported more days per week of illicit opioid use than those in the maintenance group once they were no longer receiving buprenorphine ( mean use , 1.27 [ 95 % CI , 0.60-1 .94 ] vs 0.47 [ 95 % CI , 0.19-0 .74 ] days ) .
RESULTS	Patients in the taper group had fewer maximum consecutive weeks of opioid abstinence compared with those in the maintenance group ( mean abstinence , 2.70 [ 95 % CI , 1.72-3 .75 ] vs 5.20 [ 95 % CI , 4.16-6 .20 ] weeks ) .
RESULTS	Patients in the taper group were less likely to complete the trial ( 6 of 57 [ 11 % ] vs 37 of 56 [ 66 % ] ; P < .001 ) .
RESULTS	Sixteen patients in the taper group reinitiated buprenorphine treatment after the taper owing to relapse .
CONCLUSIONS	Tapering is less efficacious than ongoing maintenance treatment in patients with prescription opioid dependence who receive buprenorphine therapy in primary care .
BACKGROUND	clinicaltrials.gov Identifier : NCT00555425 .

###24224471
BACKGROUND	The OX40/OX40L interaction contributes to an optimal T cell response following allergic stimuli and plays an important role in the maintenance and reactivation of memory T effector cells .
OBJECTIVE	We tested whether treatment with an anti-OX40L monoclonal antibody ( MAb ) would inhibit allergen-induced responses in subjects with asthma .
METHODS	Twenty-eight mild , atopic asthmatic subjects were recruited for a double-blind , randomized , placebo-controlled , parallel-group trial ( ClinicalTrials.gov identifier NCT00983658 ) to compare blockade of OX40L using a humanized anti-OX40L MAb to placebo-administered intravenously in 4 doses over 3 months .
METHODS	Allergen inhalation challenges were carried out 56 and 113 days after the first dose of study drug .
METHODS	The primary outcome variable was the late-phase asthmatic response .
METHODS	Other outcomes included the early-phase asthmatic response , airway hyperresponsiveness , serum IgE levels , blood and sputum eosinophils , safety and tolerability .
RESULTS	Treatment with anti-OX40L MAb did not attenuate the early - or late-phase asthmatic responses at days 56 or 113 compared with placebo .
RESULTS	In the anti-OX40L MAb treatment group , total IgE was reduced 17 % from pre-dosing levels , and sputum eosinophils decreased 75 % by day 113 ( both P = 0.04 ) .
RESULTS	There was no effect of anti-OX40L MAb on airway hyperresponsiveness or blood eosinophils .
RESULTS	The frequency of AEs was similar in both groups .
CONCLUSIONS	Pharmacological activity of anti-OX40L MAb was observed by decreases in serum total IgE and airway eosinophils at 16 weeks post-dosing , but there was no effect on allergen-induced airway responses .
CONCLUSIONS	It is possible that the treatment duration or dose of antibody was insufficient to impact the airway responses .

###25350473
OBJECTIVE	The aim of this study was to determine the efficacy and tolerability of hydromorphone extended release ( ER ) in patients with chronic low back pain ( LBP ) with or without a neuropathic component .
METHODS	This was a post hoc analysis of data from a multicenter , double-blind , placebo-controlled clinical trial using a randomized withdrawal design , performed in patients with moderate to severe chronic LBP .
METHODS	Patients achieving stable doses of hydromorphone ER during a 2 - to 4-week conversion and titration phase were randomized to continue treatment with hydromorphone ER or taper-down to placebo during a 12-week double-blind phase .
METHODS	The primary efficacy outcome was the mean change in 11-point Numeric Rating Scale ( NRS ) pain intensity score from randomization to the final visit of the double-blind phase .
METHODS	Tolerability was assessed by recording adverse events ( AEs ) .
METHODS	Data were analyzed separately for patients with non-neuropathic and neuropathic LBP .
RESULTS	A total of 173 patients with non-neuropathic/nociceptive LBP and 94 with neuropathic LBP were randomized into the double-blind phase .
RESULTS	During the conversion and titration phase , mean ( SD ) NRS scores decreased significantly from 6.5 ( 1.87 ) and 6.4 ( 1.99 ) at screening to 3.3 ( 0.98 ) and 3.2 ( 1.05 ) , respectively .
RESULTS	For both LBP subgroups , patients randomized to hydromorphone ER maintained this improvement over the double-blind treatment period , whereas those randomized to placebo reported significant increase in NRS scores .
RESULTS	Across subgroups , the incidence of 1 or more AE was 54 percent to 57 percent in the conversion and titration phase and 47 percent to 55 percent in the double-blind phase .
CONCLUSIONS	The results of this study indicate that hydromorphone ER is efficacious and generally well tolerated in the management of patients with non-neuropathic and neuropathic chronic LBP .

###25282284
BACKGROUND	Low-dose CT screening is recommended for individuals at high risk of developing lung cancer .
BACKGROUND	However , CT screening does not detect all lung cancers : some might be missed at screening , and others can develop in the interval between screens .
BACKGROUND	The NELSON trial is a randomised trial to assess the effect of screening with increasing screening intervals on lung cancer mortality .
BACKGROUND	In this prespecified analysis , we aimed to assess screening test performance , and the epidemiological , radiological , and clinical characteristics of interval cancers in NELSON trial participants assigned to the screening group .
METHODS	Eligible participants in the NELSON trial were those aged 50-75 years , who had smoked 15 or more cigarettes per day for more than 25 years or ten or more cigarettes for more than 30 years , and were still smoking or had quit less than 10 years ago .
METHODS	We included all participants assigned to the screening group who had attended at least one round of screening .
METHODS	Screening test results were based on volumetry using a two-step approach .
METHODS	Initially , screening test results were classified as negative , indeterminate , or positive based on nodule presence and volume .
METHODS	Subsequently , participants with an initial indeterminate result underwent follow-up screening to classify their final screening test result as negative or positive , based on nodule volume doubling time .
METHODS	We obtained information about all lung cancer diagnoses made during the first three rounds of screening , plus an additional 2 years of follow-up from the national cancer registry .
METHODS	We determined epidemiological , radiological , participant , and tumour characteristics by reassessing medical files , screening CTs , and clinical CTs .
METHODS	The NELSON trial is registered at www.trialregister.nl , number ISRCTN63545820 .
RESULTS	15,822 participants were enrolled in the NELSON trial , of whom 7915 were assigned to low-dose CT screening with increasing interval between screens , and 7907 to no screening .
RESULTS	We included 7155 participants in our study , with median follow-up of 816 years ( IQR 756-856 ) .
RESULTS	187 ( 3 % ) of 7155 screened participants were diagnosed with 196 screen-detected lung cancers , and another 34 ( < 1 % ; 19 [ 56 % ] in the first year after screening , and 15 [ 44 % ] in the second year after screening ) were diagnosed with 35 interval cancers .
RESULTS	For the three screening rounds combined , with a 2-year follow-up , sensitivity was 846 % ( 95 % CI 796-892 ) , specificity was 986 % ( 95 % CI 985-988 ) , positive predictive value was 404 % ( 95 % CI 359-447 ) , and negative predictive value was 998 % ( 95 % CI 998-999 ) .
RESULTS	Retrospective assessment of the last screening CT and clinical CT in 34 patients with interval cancer showed that interval cancers were not visible in 12 ( 35 % ) cases .
RESULTS	In the remaining cases , cancers were visible when retrospectively assessed , but were not diagnosed because of radiological detection and interpretation errors ( 17 [ 50 % ] ) , misclassification by the protocol ( two [ 6 % ] ) , participant non-compliance ( two [ 6 % ] ) , and non-adherence to protocol ( one [ 3 % ] ) .
RESULTS	Compared with screen-detected cancers , interval cancers were diagnosed at more advanced stages ( 29 [ 83 % ] of 35 interval cancers vs 44 [ 22 % ] of 196 screen-detected cancers diagnosed in stage III or IV ; p < 00001 ) , were more often small-cell carcinomas ( seven [ 20 % ] vs eight [ 4 % ] ; p = 0003 ) and less often adenocarcinomas ( nine [ 26 % ] vs 102 [ 52 % ] ; p = 0005 ) .
CONCLUSIONS	Lung cancer screening in the NELSON trial yielded high specificity and sensitivity , with only a small number of interval cancers .
CONCLUSIONS	The results of this study could be used to improve screening algorithms , and reduce the number of missed cancers .
BACKGROUND	Zorgonderzoek Nederland Medische Wetenschappen and Koningin Wilhelmina Fonds .

###24473242
BACKGROUND	Despite the beneficial effect of cardiac rehabilitation after myocardial infarction , a rehabilitation program to improve cardiorespiratory fitness and influence secondary prevention has not been implemented for ischemic stroke and transient ischemic attack ( TIA ) .
OBJECTIVE	To investigate the safety and feasibility of a post-stroke care including an exercise program after minor ischemic stroke or TIA .
METHODS	In a randomised controlled trial , 20 patients with a recent minor stroke or TIA without cardiac contraindications were randomly assigned to one of the two interventions ; post-stroke care without exercise or post-stroke care with exercise .
METHODS	Patients were evaluated at baseline , 6 and 12 months .
RESULTS	Eighteen patients completed the intervention .
RESULTS	In none of the patients cardiopulmonary contraindications for the maximal exercise test and exercise program were found .
RESULTS	No cardiovascular events occurred during the maximal exercise tests and exercise program .
RESULTS	After one year , significantly more patients in the post-stroke care with exercise group achieved the composite endpoint of optimal medical therapy .
CONCLUSIONS	Post-stroke care including an exercise program is safe and feasible in the acute phase after minor stroke or TIA and might be a way to increase effectiveness of secondary stroke prevention .
CONCLUSIONS	We are currently conducting a larger trial to validate these results .

###24965218
BACKGROUND	40 subjects with type 2 diabetes and moderate to severe CP were randomly distributed to groups receiving either NSPT or OHI .
BACKGROUND	Periodontal parameters , glycosylated haemoglobin ( HbA1c ) and high-sensitivity C-reactive protein ( hs-CRP ) were evaluated at baseline , 2 - and 3-months intervals .
METHODS	40 subjects with type 2 diabetes and moderate to severe CP were randomly distributed to groups receiving either NSPT or OHI .
METHODS	Periodontal parameters , glycosylated haemoglobin ( HbA1c ) and high-sensitivity C-reactive protein ( hs-CRP ) were evaluated at baseline , 2 - and 3-months intervals .
RESULTS	15 subjects from NSPT group and 17 from OHI group completed the study .
RESULTS	The difference in plaque index ( PI ) between NSPT and OHI groups were significant at 2 months recall ( p = 0.013 ) .
RESULTS	There was no significant difference between NSPT and OHI group for all other clinical periodontal parameters , HbA1c and CRP levels .
RESULTS	At 3 months post-therapy , periodontal parameters improved significantly in both groups with sites with probing pocket depth ( PPD ) < 4 mm reported as 98 1.8 % in NSPT group and 92 14.9 % in OHI group .
RESULTS	Mean PPD and mean probing attachment loss ( PAL ) within the NSPT group reduced significantly from baseline ( 2.56 0.57 mm , 3.35 0.83 mm ) to final visit ( 1.94 0.26 mm , 2.92 0.72 mm ) ( p = 0.003 , p < 0.001 ) .
RESULTS	For OHI group , improvements in mean PPD and mean PAL were also seen from baseline ( 2.29 0.69 mm , 2.79 0.96 mm ) to final visit ( 2.09 0.72 mm , 2.62 0.97 mm ) ( p < 0.001 for both ) .
RESULTS	Similarly , HbA1c levels decreased in both groups with NSPT group recording statistically significant reduction ( p = 0.038 ) .
RESULTS	Participants who demonstrated 50 % reduction in PPD showed significant reductions of HbA1c and hs-CRP levels ( p = 0.004 and p = 0.012 ) .
CONCLUSIONS	NSPT significantly reduced PI at 2 months post-therapy as compared to OHI .
CONCLUSIONS	Both NSPT and OHI demonstrated improvements in other clinical parameters as well as HbA1c and CRP levels .
BACKGROUND	ClinicalTrials.gov : NCT01951547 .

###25527842
BACKGROUND	The early management of orthopaedic outpatients by physiotherapists may be useful in reducing public hospital waiting lists .
BACKGROUND	Physiotherapists in Australia are prevented by legislation and funding models from investigating , prescribing , injecting and referring autonomously .
BACKGROUND	This gap in service is particularly noticeable in the management of shoulder pain in early-access physiotherapy services , as patients needing corticosteroid injection face delays or transfer to other services for this procedure .
BACKGROUND	This trial will investigate the clinical ( decision making and outcomes ) and economic feasibility of a physiotherapist prescribing and delivering corticosteroid and local anaesthetic injections for shoulder pain in an Australian public hospital setting .
METHODS	A double-blinded ( patient and assessor ) non-inferiority randomised controlled trial will compare an orthopaedic surgeon and a physiotherapist prescribing and delivering corticosteroid injections to the shoulder .
METHODS	Agreement in decision making between the two clinicians will be investigated , and economic information will be obtained for estimating disease burden and an economic evaluation .
METHODS	The surgeon and the physiotherapist will independently assess patients , and 64 eligible participants will be randomised to receive subacromial injection of corticosteroid and local anaesthetic from either the surgeon or the physiotherapist .
METHODS	Post-injection , all participants will receive physiotherapy .
METHODS	The primary outcome measure will be the Shoulder Pain and Disability Index measured at baseline , and at 6 and 12weeks post-injection .
METHODS	Analysis will be conducted on an intention-to-treat basis and compared to a per-protocol analysis .
METHODS	A cost-utility analysis will be undertaken from the perspective of the health funder .
CONCLUSIONS	Findings will assist policy makers and services in improving access for orthopaedic patients .
BACKGROUND	Australia and New Zealand Clinical Trials Registry : 12612000532808 First registered : 21 May 2012 .
BACKGROUND	First participant randomized : 16 January 2013 .

###24586292
OBJECTIVE	Intestinal inflammation is a hallmark of cystic fibrosis ( CF ) .
OBJECTIVE	Administration of probiotics can reduce intestinal inflammation and the incidence of pulmonary exacerbations .
OBJECTIVE	We investigated the composition of intestinal microbiota in children with CF and analyzed its relationship with intestinal inflammation .
OBJECTIVE	We also investigated the microflora structure before and after Lactobacillus GG ( LGG ) administration in children with CF with and without antibiotic treatment .
METHODS	The intestinal microbiota were analyzed by denaturing gradient gel electrophoresis ( DGGE ) , real-time polymerase chain reaction ( RT-PCR ) , and fluorescence in situ hybridization ( FISH ) .
METHODS	Intestinal inflammation was assessed by measuring fecal calprotectin ( CLP ) and rectal nitric oxide ( rNO ) production in children with CF as compared with healthy controls .
METHODS	We then carried out a small double-blind randomized clinical trial with LGG .
RESULTS	Twenty-two children with CF children were enrolled in the study ( median age , 7 years ; range , 2-9 years ) .
RESULTS	Fecal CLP and rNO levels were higher in children with CF than in healthy controls ( 184146 g/g vs. 5246 g/g ; 1815 vs. 2.61.2 mol/L NO2 ( - ) , respectively ; P < 0.01 ) .
RESULTS	Compared with healthy controls , children with CF had significantly different intestinal microbial core structures .
RESULTS	The levels of Eubacterium rectale , Bacteroides uniformis , Bacteroides vulgatus , Bifidobacterium adolescentis , Bifidobacterium catenulatum , and Faecalibacterium prausnitzii were reduced in children with CF. A similar but more extreme pattern was observed in children with CF who were taking antibiotics .
RESULTS	LGG administration reduced fecal CLP and partially restored intestinal microbiota .
RESULTS	There was a significant correlation between reduced microbial richness and intestinal inflammation .
CONCLUSIONS	CF causes qualitative and quantitative changes in intestinal microbiota , which may represent a novel therapeutic target in the treatment of CF. Administration of probiotics restored gut microbiota , supporting the efficacy of probiotics in reducing intestinal inflammation and pulmonary exacerbations .
BACKGROUND	ClinicalTrials.gov NCT 01961661 .

###24281285
OBJECTIVE	To investigate the therapeutic effects of a manual therapy protocol for improving pain , function , pressure pain thresholds ( PPT ) , quality of sleep , and depressive symptoms in women and men with fibromyalgia syndrome ( FMS ) .
METHODS	Eighty-nine patients were randomly assigned to experimental or control group .
METHODS	The experimental group ( 24 female , 21 male ) received 5 sessions of manual therapy and the control group ( 24 female , 21 male ) did not receive any intervention .
METHODS	PPT , pain , impact of FMS symptoms , quality of sleep , and depressive symptoms were assessed in both groups at baseline and after 48 hours of the last intervention in the experimental group .
RESULTS	The analysis of covariance found significant GroupTimeSex interactions for McGill PPI and Center for Epidemiologic Studies Depressive Symptoms Scale ( P < 0.01 ) was also found : men exhibited a larger effect size for depressive symptoms than women , whereas women exhibited a greater effect size than men in the McGill PPI .
RESULTS	A significant GroupTimeSex interaction for PPT over suboccipital , upper trapezius , supraspinatus , second rib , gluteal region , and tibialis anterior muscle was also found : men included in the experimental group experienced significant greater improvements in PPT as compared with women with FMS in the experimental group .
CONCLUSIONS	Manual therapy protocol was effective for improving pain intensity , widespread pressure pain sensitivity , impact of FMS symptoms , sleep quality , and depressive symptoms .
CONCLUSIONS	In addition , sex differences were observed in response to treatment : women and men get similar improvements in quality of sleep and tender point count , whereas women showed a greater reduction in pain and impact of FMS symptoms than men , but men reported higher decreases in depressive symptoms and pressure hypersensitivity than women .

###24930178
OBJECTIVE	This study tested the effects of two fundamental forms of distraction , including visual-manual and cognitive-audio distraction , with comparison under both operational and tactical driving .
OBJECTIVE	Strategic control remains for future study .
BACKGROUND	Driving is a complex control task involving operational , tactical , and strategic control .
BACKGROUND	Although operational control , such as lead-car following , has been studied , the influence of in-vehicle distractions on higher levels of control , including tactical and strategic , remains unclear .
METHODS	Two secondary tasks were designed to independently represent visual-manual and cognitive-audio distractions , based on multiple resource theory .
METHODS	Drivers performed operational vehicle control maneuvers ( lead-car following ) or tactical control maneuvers ( passing ) along with the distraction tasks in a driving simulator .
METHODS	Response measures included driving performance and visual behavior .
RESULTS	Results revealed drivers ' ability to accommodate either visual or cognitive distractions in following tasks but not in passing .
RESULTS	The simultaneous distraction condition led to the greatest decrement in performance .
CONCLUSIONS	Findings support the need to assess the impacts of in-vehicle distraction on different levels of driving control .
CONCLUSIONS	Future study should investigate driver distraction under strategic control .

###24926544
BACKGROUND	The PARAMOUNT Phase III trial showed that maintenance pemetrexed after pemetrexed plus cisplatin induction was well tolerated and effective for patients with advanced nonsquamous non-small-cell lung cancer .
BACKGROUND	Approximately 17 % of patients receiving maintenance therapy in this study were 70 years of age or older .
BACKGROUND	Here we report efficacy and safety results from the PARAMOUNT study for elderly ( 70 years ) and non-elderly ( < 70 years ) patients .
METHODS	Final efficacy and safety data from the PARAMOUNT study were analyzed post hoc using subgroup analyses for elderly and non-elderly patients .
RESULTS	The median age was 73 years in the elderly subgroup ( n = 92 ) and 60 years in the non-elderly subgroup ( n = 447 ) .
RESULTS	Subgroups had similar baseline characteristics , except for a higher percentage of males and patients with a performance status of one in the elderly subgroup .
RESULTS	For elderly patients , the median PFS was 6.4 months for pemetrexed and 3.0 months for placebo ; the median OS was 13.7 months for pemetrexed and 12.1 months for placebo .
RESULTS	For non-elderly patients , the median PFS was 4.0 months for pemetrexed and 2.8 months for placebo ; the median OS was 13.9 months for pemetrexed and 10.8 months for placebo .
RESULTS	Elderly patients experienced similar levels of low-grade toxicities , but had a higher percentage of grade 3/4 anemia and neutropenia than non-elderly patients , although importantly , this did not translate into increased febrile neutropenia .
CONCLUSIONS	Continuation maintenance pemetrexed had comparable survival and toxicity profiles in the elderly and non-elderly subgroups .
CONCLUSIONS	However , grade 3/4 anemia and neutropenia were numerically higher for elderly patients .

###24444280
OBJECTIVE	Ticagrelor is a reversibly binding and selective P2Y12 - receptor antagonist approved for the prevention of atherothrombotic events in patients with acute coronary syndromes .
OBJECTIVE	As bleeding events remain a hazard with antiplatelet therapy , this study investigated the effect of the vasopressin agonist , desmopressin , on ticagrelor-induced bleeding time prolongation .
OBJECTIVE	Desmopressin has previously been shown to improve primary haemostasis and is widely used as first-line therapy for individuals with bleeding disorders .
METHODS	In a randomized , double-blind , 2-period crossover study , healthy volunteers received ticagrelor ( 270mg loading dose ; 180mgbid ) for 5days .
METHODS	On Day 5 , desmopressin ( 03g/kg ) or saline intravenous infusions were administered .
METHODS	The impact of desmopressin on bleeding time , inhibition of platelet aggregation ( IPA ) , platelet function and ticagrelor pharmacokinetic parameters was investigated .
RESULTS	Twenty-one volunteers ( 81 % male ) were enrolled .
RESULTS	Median [ range ] bleeding times were slightly reduced with ticagrelor plus desmopressin compared with ticagrelor alone ( 750 [ 3-17 ] vs. 1050 [ 3-25 ] min at 25h ) .
RESULTS	Median reductions in bleeding time from baseline were generally similar between ticagrelor plus desmopressin compared with ticagrelor alone at all time points .
RESULTS	Co-administration of desmopressin had no impact on IPA , although platelet reactivity was significantly increased ( von Willebrand Factor antigen : GLS mean AUEC was 4667 % .
RESULTS	h for ticagrelor plus desmopressin compared with 2750 % .
RESULTS	h for ticagrelor alone ) .
RESULTS	Desmopressin did not influence the pharmacokinetics of ticagrelor .
CONCLUSIONS	Desmopressin had no significant effect on bleeding time or inhibition of platelet aggregation by ticagrelor , although primary haemostatic activity was significantly increased .
CONCLUSIONS	Ticagrelor pharmacokinetic parameters were not affected by co-administration with desmopressin .
CONCLUSIONS	Therefore , desmopressin is unlikely to be an effective therapeutic agent for control of the potential bleeding events associated with ticagrelor .

###24227448
BACKGROUND	Sedation with dexmedetomidine may facilitate ventilator liberation and limit the occurrence of delirium .
BACKGROUND	No trial has assessed patient recall or the development of psychological outcomes after dexmedetomidine sedation .
BACKGROUND	This pilot study evaluated whether transitioning benzodiazepine sedation to dexmedetomidine alters patient recall and the incidence of anxiety , depression , or acute stress disorder ( ASD ) .
METHODS	This investigation was a randomized , double-blind , single-center study .
METHODS	Existing continuous benzodiazepine sedation was converted to dexmedetomidine or midazolam when patients qualified for daily awakenings .
METHODS	Sedation was titrated to achieve Riker sedation agitation scores of 3 to 4 .
METHODS	The intensive care unit ( ICU ) Stressful Experiences Questionnaire , hospital anxiety and depression scale , and the impact of event scale-revised were administered before hospital discharge to assess recall , anxiety , depression , and manifestations of ASD .
RESULTS	A total of 11 patients received dexmedetomidine , and 12 patients received midazolam .
RESULTS	Median dosing was 0.61 g/kg/h for 3.5 days for dexmedetomidine and 3.7 mg/h for 3 days for midazolam .
RESULTS	Attainment of goal sedation and analgesia was similar ; however , more dexmedetomidine patients experienced agitation and pain .
RESULTS	The median duration of mechanical ventilation from study drug initiation to extubation was 3.4 days in dexmedetomidine patients and 2.9 days in midazolam patients .
RESULTS	Dexmedetomidine patients remembered 18.5 experiences compared with 8.5 in midazolam patients ( P = .015 ) .
RESULTS	Rates of anxiety and depression were similar .
RESULTS	In all , 5 ( 62.5 % ) dexmedetomidine patients and 1 ( 12.5 % ) midazolam patient manifested ASD ( P = .063 ) , and 1 dexmedetomidine patient and 5 midazolam patients developed new-onset delirium ( P = .07 ) .
RESULTS	Hypotension occurred in 10 ( 90.9 % ) dexmedotomidine patients and 6 ( 50 % ) midazolam patients ( P = .069 ) .
CONCLUSIONS	Transitioning benzodiazepine sedation to dexmedetomidine when patients qualify for daily awakenings may reduce the development of delirium and facilitate remembrance of ICU experiences but may lead to manifestations of ASD .
CONCLUSIONS	Monitoring hypotension is required for both the sedatives .
CONCLUSIONS	Additional comparative studies focusing on the long-term impact of ICU recall and psychological outcomes are needed .

###25245218
BACKGROUND	We investigated the efficacy of concurrent chemoradiotherapy ( CCRT ) over radiotherapy ( RT ) in Chinese patients with locally advanced cervical carcinoma .
METHODS	Between January 2005 and January 2008 , 192 patients with squamous cell carcinoma of the cervix were included in the study : 96 in arm A ( CCRT with 20 mg/m2 cisplatin for 5 days ) and 96 in arm B ( RT ) .
METHODS	The overall response rate was the primary endpoint .
METHODS	The secondary endpoints included overall survival , progression-free survival , and toxicity .
RESULTS	The 5-year overall response rate was 67 % and 53 % for the CCRT and RT arms , respectively , and the difference was statistically significant , while the median overall survival was 68 months ( range 3-85 months ) and 61 months ( range 4-83 months ) , respectively ( P = 0.009 ) .
RESULTS	In addition , the median progression-free survival for CCRT was 62 months ( range 3-83 months ) , whereas it was 51 months ( range 4-81 months ) for the RT arm ( P = 0.025 ) .
RESULTS	The toxicity profile , both acute and late , was comparable in both arms .
CONCLUSIONS	In summary , we demonstrate that CCRT was effective and better tolerated than RT alone in Chinese patients with locally advanced cervical carcinoma .
BACKGROUND	Chinese Clinical Trials Register : ChiCTR-TRC-13003979 .

###24851582
OBJECTIVE	To investigate an effectiveness of walking exercise program applying the Theory of Planned Behavior in people at risk of hypertension in Samut Sakorn province .
METHODS	The present study is a quasi-experimental research .
METHODS	The inclusion criteria were people aged 35-59 years old , systolic blood pressure 120-139 mmHg , and diastolic blood pressure 80-89 mmHg .
METHODS	Participants were randomly selected into the experimental group ( n = 34 ) and the comparison group ( n = 34 ) .
METHODS	The experimental group received activities including health information , benefits of walking exercise , group discussion in exercise barriers , modeling and experience exchange , walking exercise practice , and practice on using walking monitoring booklet at the baseline and the 2nd week , whereas the comparison group received only health information and the booklet practice at the beginning of the intervention .
METHODS	Data were collected by self-administered questionnaires at the baseline , 2nd week , and 6th week .
METHODS	Statistical analysis was performed using Chi-square , Independent t-test , and repeated measures ANOVA .
RESULTS	The experimental group made significant improvements in attitude towards walking exercise , perceived behavior control , subjective norm , walking exercise intention , and walking exercise over time ( p < 0.05 ) .
RESULTS	However , no statistically significant differences between the experimental and the comparison groups were found in subjective norm , systolic and diastolic blood pressure from baseline to the 6th week .
RESULTS	The experimental group had a significant higher mean difference score of attitude towards walking exercise , perceived behavior control , walking exercise intention , walking exercise , weight , and BMI compared to those in the comparison group ( p < 0.05 ) .
RESULTS	Subjective norm scores in the experimental group were more likely to increase from baseline to the 6th week , but not a significant difference .
CONCLUSIONS	Walking exercise programs applying the Theory of Planned Behavior should be recommended in people at risk of hypertension .
CONCLUSIONS	Health professionals should also be motivated to practice with this program .

###24428769
BACKGROUND	Alcohol consumption has substantially increased in China during the last 3 decades .
BACKGROUND	Socioeconomic status ( SES ) most likely influences the development of alcoholic liver disease ( ALD ) in Chinese people who excessively consume alcohol .
BACKGROUND	At the present time , however , little information is available in this field .
BACKGROUND	The objectives of this study were to investigate the population-based prevalence of ALD and to identify the correlation of socioeconomics with the development of ALD .
METHODS	A cross-sectional survey was conducted in 8,186 individuals who resided in Shandong Province and were over 18 years old in 2011 using a randomized multistage clustered sampling approach .
METHODS	Among these subjects , 7,295 ( 89.12 % ) were interviewed .
METHODS	Questionnaires covered demographic characteristic , medical history , current medication , and health-relevant behavior , particularly alcohol consumption , dietary habit , and physical activity .
METHODS	Anthropometric measurements , biochemical tests , and abdominal ultrasonography were also performed .
RESULTS	Among the 7,295 subjects , 624 ( 8.55 % ) were diagnosed with ALD .
RESULTS	The prevalence rate was significantly higher in males than in females ( 15.76 % in males vs. 1.42 % in females , p < 0.05 ) .
RESULTS	In this population , the risk of ALD was highest in the 40 - to 49-year-old group .
RESULTS	The incidence of ALD was highest in individuals who had a high level of occupation .
RESULTS	Individuals who had received a low level of education had the highest incidence of ALD .
RESULTS	Subjects with a low family income were more likely to have ALD than did those with an abundant family income .
RESULTS	Currently , unmarried individuals had a higher incidence of ALD in the overall population .
CONCLUSIONS	ALD is prevalent in north-eastern China .
CONCLUSIONS	SES correlates with the development of ALD .
CONCLUSIONS	Socioeconomic risk factors for ALD in north-eastern China include male gender , middle age , currently unmarried , low level of education , low family income , and high level of occupation .

###24746485
BACKGROUND	When switching from usual brand cigarettes , very low nicotine content ( VLNC ) cigarettes lead to a reduction in the number of cigarettes smoked , toxicant exposure , withdrawal symptoms and dependence .
BACKGROUND	One area that has been relatively unexplored is what factors might moderate the effects of VLNC cigarettes .
BACKGROUND	This exploratory analysis focuses on sex differences in responses to VLNC cigarettes and nicotine replacement therapy .
METHODS	An exploratory secondary analysis of a randomized trial of 235 participants ( 58 % female , mean age 47 years ) comparing a ) 0.05-0 .09 mg nicotine yield cigarettes ; b ) 21 mg nicotine patch and 3 ) 0.05-0 .09 nicotine yield cigarettes with 21 mg nicotine patch was conducted .
METHODS	We focused on sex differences in product use , and impact of products on withdrawal response from usual brand cigarettes and abstinence by randomized group .
RESULTS	The combination of VLNC cigarettes and nicotine patch was more effective in reducing use of VLNC cigarettes and withdrawal symptoms among males than females , whereas females were equally responsive to VLNC cigarettes with and without the nicotine patch .
RESULTS	Females were more likely to quit smoking than males when assigned to either of the conditions that incorporated the VLNC cigarettes ; however , males were more likely to quit smoking in the nicotine patch alone condition than females .
CONCLUSIONS	Sex of the smoker may be an important determinant for effects of VLNC cigarettes and nicotine patch .
CONCLUSIONS	Future large randomized trials to confirm these results are needed .

###25403146
BACKGROUND	This study investigated whether early intervention based on additional use of sidestream capnography could reduce the incidence of oxygen desaturation and hypoxic events in patients receiving propofol anesthesia during surgical abortion .
METHODS	We recruited 704 ASAI-III female patients , 18-52 years old and scheduled for planned painless surgical abortion , and randomized them into a control group ( n = 359 ) receiving standard monitoring and an experimental group ( n = 341 ) receiving standard monitoring and additional capnography .
METHODS	Exclusion criteria were preexisting cardiovascular disease , preexisting hypotension , bradycardia or arrhythmia , and drug allergy .
METHODS	Anesthesia was induced in all patients with propofol using target-controlled infusion at a target propofol plasma concentration of 4 g/ml .
METHODS	All patients received flurbiprofen axetil 50 mg and 0.5 g/kg fentanyl 5 min before anesthesia .
METHODS	Bispectral index was used and maintained between 45 and 60 .
METHODS	Main outcome measures were apnea or abnormal ventilation status , rate of oxygen desaturation , occurrence of hypoxia and severe hypoxia , and perioperative side effects .
RESULTS	The experimental group had significantly higher rate of apnea or abnormal ventilation , significantly lower rate of oxygen desaturation , and significant lower occurrence of hypoxia and severe hypoxia compared to the control group .
RESULTS	We found no statistically significant differences between the 2 groups in the rates of increased oxygen supplementation , assisted ventilation , bradycardia , hypotension , dosage of atropine , dosage of ephedrine or phenylephrine , and the amount of propofol consumed .
CONCLUSIONS	Sidestream capnographic monitoring improves early detection of alterations in ventilation parameters and reduces the incidence of oxygen desaturation and hypoxemia resulting from propofol anesthesia during surgical abortion .

###24669646
BACKGROUND	Sympathetic response associated with laryngoscopy and endotracheal intubation is recognised as a potential cause for a number of complications especially in hypertensive patients .
BACKGROUND	Various methods have been used to attenuate these haemodynamic responses ; however most of the studies are in normotensive patients .
BACKGROUND	The aim of our study was to compare the effect of oral clonidine and 1/V fentanyl with oral placebo and I/V fentanyl in attenuating the haemodynamic responses to laryngoscopy and intubation in known hypertensive patients .
METHODS	In a double blind randomised controlled trial .
METHODS	60 hypertensive patients , taking antihypertensive drugs and with systolic blood pressure below 160 ( mmHg and diastolic blood pressure below 100 mmHg scheduled for elective surgeries , requiring oral endotracheal intubation and age ranging from 40-65 years were included in this study and randomly divided into Group A ( clonidine 0.2 mg + fentanyl 2 microg/Kg ) and Group B ( Placebo + fentanyl 2 microg/Kg ) .
RESULTS	Demographic data were comparable in both groups .
RESULTS	There were no statistically significant differences between the two groups in the duration of laryngoscopy and intubation .
RESULTS	There was statistically significant attenuation in heart rate in both groups ( p = 0.020 ) .
RESULTS	The trends of attenuation of systolic blood pressure , diastolic blood pressure and mean arterial pressure in Group A compared to Group B , were statistically significant ( p = 0.034 , 0.011 , 0.011 respectively ) .
CONCLUSIONS	Clonidine , under the present study design attenuates the haemodynamic response to laryngoscopy and endotracheal intubation in known hypertensive patients .

###24885551
BACKGROUND	Borderline Personality Disorder ( BPD ) is a serious psychiatric condition associated with substantial mortality , burden and public health costs .
BACKGROUND	DBT is the treatment model with the largest number of published research articles showing effectiveness .
BACKGROUND	However , some patients are not sufficiently engaged in outpatient treatment while presenting severe parasuicidal behavior , making hospitalization necessary .
BACKGROUND	The Center for Personality Disorders Jelgersma developed an intensive 12-week inpatient DBT program that ( i ) rapidly reduces core borderline symptoms like suicidal behavior , ( ii ) minimizes the negative effects of an inpatient setting , and ( iii ) enhances compliance with outpatient treatment .
BACKGROUND	We evaluate the ( cost - ) effectiveness of this experimental program .
METHODS	Seventy patients , aged 18 to 45years with a primary diagnosis of BPD , showing a chronic pattern of parasuicidal gestures and/or reporting high degrees of severity of other borderline symptoms , are randomly allocated to the control and intervention groups .
METHODS	Subjects in the control group receive standard outpatient DBT , provided in one of three regular mental health settings in GGZ Rivierduinen .
METHODS	Subjects in the intervention group receive 12weeks of intensified inpatient DBT plus six months of standard DBT , provided in the Center for Personality Disorders Jelgersma .
METHODS	The primary outcome is the number of suicide attempts/self-harming acts .
METHODS	Secondary outcomes are severity of other borderline complaints , quality of life , general psychopathological symptoms and health care utilization and productivity costs .
METHODS	Data are gathered using a prospective , two ( group : intervention and control ) by five ( time of measurement ) repeated measures factorial design.Participants will complete three-monthly outcome assessments in the course of therapy : at baseline , and 12 , 24 , 36 and 52weeks after the start of the treatment .
METHODS	The period of recruitment started in March 2012 and the study will end in December 2014 .
CONCLUSIONS	Highly suicidal outpatient patients can pose a dilemma for mental health care professionals .
CONCLUSIONS	Although hospitalization seems inevitable under some circumstances , it has proven to be harmful in its own right .
CONCLUSIONS	This paper outlines the background and methods of a randomized trial evaluating the possible surplus value of a short-term inpatient DBT program .

###24815851
BACKGROUND	Poor CD4 lymphocyte recovery on antiretroviral therapy ( ART ) is associated with reduced function of the thymus .
BACKGROUND	Palifermin ( keratinocyte growth factor ) , by providing support to the thymic epithelium , promotes lymphopoiesis in animal models of bone marrow transplantation and graft-versus-host disease .
METHODS	In AIDS Clinical Trials Group A5212 , a randomized , double-blind , placebo-controlled study , 99 HIV-infected patients on ART with plasma HIV-1 RNA levels 200 copies per milliliter for 6 months and CD4 lymphocyte counts < 200 cells per cubic milliliter were randomized 1:1:1:1 to receive once daily intravenous administration of placebo or 20 , 40 , or 60 g/kg of palifermin on 3 consecutive days .
RESULTS	The median change in the CD4 T-cell count from baseline to week 12 was not significantly different between the placebo arm [ 15 ( -16 , 23 ) cells/mm ] and the 20-g/kg dose [ 11 ( 2 , 32 ) cells/mm ] , the 40-g/kg dose [ 12 ( -2 , 25 ) cells/mm ] , or the 60-g/kg dose arm [ 8 ( -13 , 35 ) cells/mm ] of palifermin .
RESULTS	No significant changes were observed in thymus size or in the number of naive T cells or recent thymic emigrants .
CONCLUSIONS	Palifermin in the doses studied was not effective in improving thymic function and did not raise CD4 lymphocyte counts in HIV-infected patients with low CD4 cell counts despite virologically effective ART .

###25438966
OBJECTIVE	The Centers for Disease Control and Prevention highlights the importance of evaluating interventions rigorously and recommends evaluating new interventions against interventions with established efficacy .
OBJECTIVE	Competencias para adolescentes con una sexualidad saludable ( COMPAS ) is a school-based HIV prevention program that has been shown to be effective in reducing sexual risk behaviors among adolescents in Spain .
OBJECTIVE	This study evaluates the efficacy of COMPAS program compared with a Spanish-culture adapted version of Cudate !
OBJECTIVE	( Take Care of Yourself ) , an evidence-based HIV prevention curriculum designed for Latino adolescents in the US .
METHODS	This cluster randomized controlled trial involved 1,563 adolescents attending 18 public high schools located in 5 provinces of Spain .
METHODS	The schools invited to participate were enrolled and randomly assigned to the three experimental conditions : COMPAS , Cudate !
METHODS	, and control group ( CG ; no intervention ) .
RESULTS	Generalized estimating equation analyses revealed that both interventions improved attitudes toward people living with human immunodeficiency syndrome ( HIV ) / AIDS and the HIV test and increased HIV/sexually transmitted infection knowledge and intention to engage in safer sex behaviors compared with the CG .
RESULTS	Although only COMPAS increased participants ' sexual risk perception and attitude toward condom use compared with the CG , the two interventions did not significantly differ on any outcome .
CONCLUSIONS	When compared with an established program , COMPAS was at least as effective at increasing the intention to engage in safer sex behaviors as the evidence-based intervention .

###24283084
BACKGROUND	Childbirth has been recognised as the most painful experience known to women .
BACKGROUND	This study aimed at studying the efficacy and safety of the single shot spinal analgesia for pain relief in labour .
METHODS	One hundred and twelve parturients in labour were randomized into two groups of 55 paturients each .
METHODS	Group B received 2.5 mg of spinal plain bupivacaine only while Group BF had 2.5 mg plain bupivacaine with 25 gg of fentanyl .
METHODS	Onset of sensory block , time to achieve maximum sensory block , duration of sensory and motor block and the level of block were recorded .
METHODS	The need for oxytocin augmentation , instrumental delivery , neonatal Apgar scores and umbilical artery blood pH were recorded .
RESULTS	The numeric rating pain scores for groups B and BF were significantly reduced from a mean prespinal score of 8.17 + / - 0.96 cm and 8.30 + / - 0.23 cm respectively to a mean post-spinal pain score of 0.23 + / - 0.45 cm and 0.09 + / - 0.47 cm respectively , p = 0.000 .
RESULTS	The mean duration of analgesia in Group B was 61.60 + / - 6.47 mins while it was 128.98 + / - 21.61 mins in Group BF , p = 0.000 .
CONCLUSIONS	The study showed that low dose spinal bupivacaine either alone or in combination with fentanyl is safe for labour analgesia , but the combination f bupivacaine with fentanyl provided much more prolonged pain relief

###25601978
BACKGROUND	Treatment of women at risk for preterm birth with repeat doses of glucocorticoids reduces neonatal morbidity but could have adverse long-term effects on cardiometabolic health in offspring .
BACKGROUND	We assessed whether exposure to repeat antenatal betamethasone increased risk factors for later cardiometabolic disease in children whose mothers participated in the Australasian Collaborative Trial of Repeat Doses of Corticosteroids .
METHODS	Women were randomized to betamethasone or placebo treatment , 7 days after an initial course of glucocorticoids , repeated each week that they remained at risk for preterm birth at < 32 weeks ' gestation .
METHODS	In this follow-up study , children were assessed at 6 to 8 years ' corrected age for body composition , insulin sensitivity , ambulatory blood pressure , and renal function .
RESULTS	Of 320 eligible childhood survivors , 258 were studied ( 81 % ; 123 repeat betamethasone group ; 135 placebo [ single course ] group ) .
RESULTS	Children exposed to repeat antenatal betamethasone and those exposed to placebo had similar total fat mass ( geometric mean ratio 0.98 , 95 % confidence interval [ CI ] 0.78 to 1.23 ) , minimal model insulin sensitivity ( geometric mean ratio 0.89 , 95 % CI 0.74 to 1.08 ) , 24-hour ambulatory blood pressure ( mean difference systolic 0 mm Hg , 95 % CI -2 to 2 ; diastolic 0 mm Hg , 95 % CI -1 to 1 ) , and estimated glomerular filtration rate ( mean difference 1.2 mL/min/1 .73 m ( 2 ) , 95 % CI -3.2 to 5.6 ) .
CONCLUSIONS	Exposure to repeat doses of antenatal betamethasone compared with a single course of glucocorticoids does not increase risk factors for cardiometabolic disease at early school age .

###24655586
OBJECTIVE	The impact of Hatha yoga as add-on treatment to quetiapine fumarate extended release ( QXR ) or escitalopram ( ESC ) in depressed patients on hypothalamic-pituitary-adrenal ( HPA ) axis activity was assessed .
METHODS	60 inpatients suffering from major depressive disorder ( MDD ) according to DSM-IV were randomized for a 5 week treatment with Yoga or not ( control group ) and with either QXR ( 300mg/day ) or ESC ( 10mg/day ) .
METHODS	Serial dexamethasone/corticotropin releasing hormone ( DEX/CRH ) tests were performed to assess HPA axis function .
METHODS	The Hamilton Depression Rating Scale ( 21-HAMD ) was used weekly .
RESULTS	A more pronounced down regulation of the HPA axis activity due to yoga could not be detected .
RESULTS	The stepwise long term cortisol reduction was seen in both medication groups , irrespectively of yoga add-on treatment .
RESULTS	In addition , cortisol improvers in week 1 of therapy ( reduction in cortisol peak value within the DEX/CRH test ) reached significant greater amelioration of depressive symptoms after 5 weeks .
CONCLUSIONS	Our results suggest that antidepressant agents down regulate HPA axis function to a greater extent than additional Hatha yoga treatment .
CONCLUSIONS	Moreover , an early reduction of HPA system hyperactivity after one week of pharmacological treatment seems to raise the possibility of a favorable treatment response .

###25567818
OBJECTIVE	Difficult patients comprise at least 15 % of ambulatory visits and are associated with clinician burnout .
OBJECTIVE	No structured procedure has been reported to assist health care practitioners with these challenging relationships .
OBJECTIVE	This randomized trial evaluated whether a pre - and postvisit patient-centered and clinician-reflective technique called BREATHE OUT improved clinician satisfaction during visits with patients perceived by the clinician as difficult .
METHODS	Six family medicine residency clinics paired as urban , suburban , and rural sites were randomized by clinic to the BREATHE OUT intervention or usual care of difficult patients .
METHODS	A total of 57 physician faculty , nurse practitioners , physician assistants , and residents participated .
METHODS	The validated Physician Satisfaction Scale ( PSS ) was administered and analyzed using hierarchical linear modeling to assess differences between the intervention and control groups .
RESULTS	The BREATHE OUT intervention improved the PSS score ( P = .02 ) in the intervention group compared with the usual care group .
RESULTS	Female practitioners reported worse PSS scores compared with their male counterparts despite whether they used BREATHE OUT ( P = .009 ) .
CONCLUSIONS	Application of the BREATHE OUT questionnaire before and after visits improved clinician satisfaction with difficult patient encounters .

###25560342
BACKGROUND	Helicobacter pylori infection is a common chronic human bacterial infection .
BACKGROUND	Triple - therapy regimen containing a proton pump inhibitor , clarithromycin , and either amoxicillin or metronidazole is commonly used as first-line treatment for its eradication .
BACKGROUND	However , it may not provide the acceptable eradication rate .
BACKGROUND	The present study was designed to evaluated efficacy of low dose furazolidone with amoxicillin and omeprazole for eradication of H - pylori .
METHODS	One hundred twenty patients with non - ulcer dyspepsia or peptic ulcer confirmed by upper GI endoscopy , plus H - pylori infection confirmed by rapid urease test were included in the study .
METHODS	They were randomly divided into two groups , and then received clarithromycin , amoxicillin , and omeprazole , or furazolidone ( 100 mg PO bid ) , amoxicillin , and omeprazole .
METHODS	They were evaluated using urea breath test at the end of the study .
RESULTS	The eradication rates were 57.6 % and 78.8 % in clarithromycin and furazolidone groups , respectively .
RESULTS	Their difference was statistically significant ( P value 0.013 ) .
RESULTS	No side effect was seen in the furazolidone group .
CONCLUSIONS	Low dose furazolidone rather than clarithromycin can be used as low - cost and effective drug for eradication of H - pylori , in combination with amoxicillin and omeprazole .

###24331773
OBJECTIVE	We examined the effect of a 12-week family-based cognitive behavioural weight management programme developed for use in primary care settings .
METHODS	The sample consisted of 49 children with obesity ( aged 7-13 years ; mean SD : 10.68 1.24 ) .
METHODS	Families were randomly assigned to immediate start-up of treatment or to a 12-week waiting list condition .
METHODS	Outcome measures were body mass index standard deviation score ( BMI SDS ) , self-esteem , symptoms of depression and blood parameters indicative of cardio-metabolic risk .
METHODS	Assessments were conducted at baseline , post-treatment , post-waiting list and 12 months after treatment termination .
RESULTS	The mean reduction for the treatment group was -0.16 BMI SDS units compared with an increase of 0.04 units for the waiting list group ( p = .001 ) .
RESULTS	For the entire sample , there was a significant post-treatment improvement on BMI SDS ( p = .001 ) , all self-esteem measures ( p = .001 -.041 ) and symptoms of depression ( p = .004 ) .
RESULTS	The mean BMI SDS reduction was -0.18 units post-treatment , and it was maintained at 12-month follow-up .
RESULTS	Significant reductions were found in blood lipid levels of total cholesterol ( p = .03 ) , LDL-cholesterol ( p = .005 ) and HDL-cholesterol ( p = .01 ) at 12-month follow-up .
RESULTS	The favourable effect on most of the psychological measures waned from post-treatment to follow-up , but not approaching baseline levels .
RESULTS	Boys demonstrated significantly greater reductions in BMI SDS than girls ( p = .001 ) , while baseline psychiatric co-morbidity did not influence BMI SDS outcome .
CONCLUSIONS	The treatment shows significant and favourable effects on BMI SDS , self-esteem and symptoms of depression compared with a waiting list condition .

###25220488
OBJECTIVE	To determine , at 6 weeks postsurgery , if a monitored home exercise program ( HEP ) is not inferior to usual care rehabilitation for patients undergoing primary unilateral total knee replacement ( TKR ) surgery for osteoarthritis .
METHODS	We conducted a multicenter , randomized clinical trial .
METHODS	Patients ages 45-75 years were allocated at the time of hospital discharge to usual care rehabilitation ( n = 196 ) or the HEP ( n = 194 ) .
METHODS	Outcomes assessed 6 weeks after surgery included the Western Ontario and McMaster Universities Osteoarthritis Index pain and physical function subscales , knee range of motion , and the 50-foot walk time .
METHODS	The upper bound of the 95 % confidence interval ( 95 % CI ) mean difference favoring usual care was used to determine noninferiority .
RESULTS	At 6 weeks after surgery there were no significant differences between usual care and HEP , respectively , for pain ( 7.4 and 7.2 ; 95 % CI mean difference [ MD ] -0.7 , 0.9 ) , physical function ( 22.5 and 22.4 ; 95 % CI MD -2.5 , 2.6 ) , knee flexion ( 96 and 97 ; 95 % CI MD -4 , 2 ) , knee extension ( -7 and -6 ; 95 % CI MD -2 , 1 ) , or the 50-foot walk time ( 12.9 and 12.9 seconds ; 95 % CI MD -0.8 , 0.7 seconds ) .
RESULTS	At 6 weeks , 18 patients ( 9 % ) allocated to usual care and 11 ( 6 % ) to the HEP did not achieve 80 knee flexion .
RESULTS	There was no difference between the treatment allocations in the number of hospital readmissions .
CONCLUSIONS	The HEP was not inferior to usual care as an early rehabilitation protocol after primary TKR .

###25446068
OBJECTIVE	To evaluate muscle fatigue and participant pain in the upper back , cervical , and arm muscles associated with microlaryngeal surgery ( MLS ) in standardized favorable and unfavorable ergonomic positions .
METHODS	Individual randomized counterbalanced design .
METHODS	Electromyographic sensors were placed on targeted muscles involved with performing MLS on 18 otolaryngology residents/fellows .
METHODS	Subjects were randomly counterbalanced in both favorable and unfavorable positions while completing simulated laryngeal microsurgical tasks .
METHODS	Participants reported their extent of muscle discomfort in targeted muscle regions on a standardized survey .
RESULTS	Muscle fatigue and self-reported pain were reduced , and productivity was improved in the favorable position .
RESULTS	In the lower trapezius , significantly less muscle activation ( P = 0.025 ) and less pain ( P < 0.05 ) were found while in the favorable position compared to the unfavorable position .
CONCLUSIONS	This is the first study to demonstrate electromyographic evidence of decreased muscle activation and fatigue , in addition to self-reported pain with a more favorable microsurgical ergonomic position , which may help surgeons avoid musculoskeletal injuries .

###24782108
OBJECTIVE	To determine if functional discharge readiness and mobility following total knee arthroplasty ( TKA ) for osteoarthritis is delayed after femoral nerve block ( FNB ) with or without patient-controlled analgesia ( PCA ) opioid compared with PCA opioid alone .
METHODS	We analyzed secondary outcomes from a randomized controlled trial with 200 patients undergoing unilateral TKA .
METHODS	Experimental group 1 received single-injection FNB with intravenous PCA opioid , experimental group 2 received continuous FNB , and the control group received PCA opioid alone .
METHODS	FNB was administered using bupivacaine .
METHODS	Patients followed a structured TKA pathway .
METHODS	Discharge readiness outcomes included achievement of 90 knee flexion , independent walking , and stair climbing , and were assessed daily before discharge or day 6 , whichever came first .
METHODS	Mobility outcomes included the Timed Up and Go ( TUG ) test , the 6-Minute Walk Distance ( 6MWD ) , and self-reported physical function , and were assessed at weeks 2 and 12 .
METHODS	TUG was also assessed on days 3 to 6 , postoperation .
RESULTS	Both FNB groups ( 77 % ) were more likely to achieve 90 knee flexion compared with the control group ( 59 % ) ; odds ratio ( OR ) 2.3 , 95 % confidence interval ( 95 % CI ) 1.1 , 4.8 for single-injection FNB , and OR 2.3 , 95 % CI 1.1 , 4.9 for continuous FNB .
RESULTS	There were no significant differences in independent walking and stair-climbing ability before discharge , TUG , 6MWD , or self-reported physical function , between the FNB groups compared with the control group .
CONCLUSIONS	After TKA , FNB ( single-injection with PCA opioid or continuous ) does not delay achievement of 90 knee flexion or other measures of functional discharge readiness and mobility compared with PCA opioid alone .

###24470641
OBJECTIVE	In preterm infants receiving supplemental oxygen , routine manual control ( RMC ) of the fraction of inspired oxygen ( FIO2 ) is often difficult and time consuming .
OBJECTIVE	We developed a system for closed-loop automatic control ( CLAC ) of the FIO2 and demonstrated its short-term safety and efficacy in a single-center study .
OBJECTIVE	The objective of this study was to test the hypothesis that this system is more effective than RMC alone in maintaining arterial oxygen saturation within target levels when evaluated over 24 hours under routine conditions and with different target levels .
METHODS	We performed a multicenter , randomized controlled , crossover clinical trial in 34 preterm infants receiving mechanical ventilation or nasal continuous positive airway pressure and supplemental oxygen .
METHODS	Twenty-four-hour periods with RMC were compared with 24-hour periods of RMC supported by CLAC .
RESULTS	The median ( range ) percentage of time with arterial oxygen saturation levels within target range was 61.4 ( 31.5-99 .5 ) for RMC and 71.2 ( 44.0-95 .4 ) for CLAC ( P < .001 ) .
RESULTS	The median ( range ) number of manual FIO2 adjustments was reduced from 77.0 ( 0.0-224 .0 ) for RMC to 52.0 ( 10.0-317 .0 ) for CLAC ( P = .007 ) .
CONCLUSIONS	CLAC may improve oxygen administration to preterm infants receiving mechanical ventilation or nasal continuous positive airway pressure while reducing workload related to RMC .

###25439691
BACKGROUND	Dacomitinib is an irreversible pan-EGFR family tyrosine kinase inhibitor .
BACKGROUND	Findings from a phase 2 study in non-small cell lung cancer showed favourable efficacy for dacomitinib compared with erlotinib .
BACKGROUND	We aimed to compare dacomitinib with erlotinib in a phase 3 study .
METHODS	In a randomised , multicentre , double-blind phase 3 trial in 134 centres in 23 countries , we enrolled patients who had locally advanced or metastatic non-small-cell lung cancer , progression after one or two previous regimens of chemotherapy , Eastern Cooperative Oncology Group ( ECOG ) performance status of 0-2 , and presence of measurable disease .
METHODS	We randomly assigned patients in a 1:1 ratio to dacomitinib ( 45 mg/day ) or erlotinib ( 150 mg/day ) with matching placebo .
METHODS	Treatment allocation was masked to the investigator , patient , and study funder .
METHODS	Randomisation was stratified by histology ( adenocarcinoma vs non-adenocarcinoma ) , ethnic origin ( Asian vs non-Asian and Indian sub-continent ) , performance status ( 0-1 vs 2 ) , and smoking status ( never-smoker vs ever-smoker ) .
METHODS	The coprimary endpoints were progression-free survival per independent review for all randomly assigned patients , and for all randomly assigned patients with KRAS wild-type tumours .
METHODS	The study has completed accrual and is registered with ClinicalTrials.gov , number NCT01360554 .
RESULTS	Between June 22 , 2011 , and March 12 , 2013 , we enrolled 878 patients and randomly assigned 439 to dacomitinib ( 256 KRAS wild type ) and 439 ( 263 KRAS wild type ) to erlotinib .
RESULTS	Median progression-free survival was 26 months ( 95 % CI 19-28 ) in both the dacomitinib group and the erlotinib group ( stratified hazard ratio [ HR ] 0941 , 95 % CI 0802-1104 , one-sided log-rank p = 0229 ) .
RESULTS	For patients with wild-type KRAS , median progression-free survival was 26 months for dacomitinib ( 95 % CI 19-29 ) and erlotinib ( 95 % CI 19-30 ; stratified HR 1022 , 95 % CI 0834-1253 , one-sided p = 0587 ) .
RESULTS	In patients who received at least one dose of study drug , the most frequent grade 3-4 adverse events were diarrhoea ( 47 [ 11 % ] patients in the dacomitinib group vs ten [ 2 % ] patients in the erlotinib group ) , rash ( 29 [ 7 % ] vs 12 [ 3 % ] ) , and stomatitis ( 15 [ 3 % ] vs two [ < 1 % ] ) .
RESULTS	Serious adverse events were reported in 52 ( 12 % ) patients receiving dacomitinib and 40 ( 9 % ) patients receiving erlotinib .
CONCLUSIONS	Irreversible EGFR inhibition with dacomitinib was not superior to erlotinib in an unselected patient population with advanced non-small-cell lung cancer or in patients with KRAS wild-type tumours .
CONCLUSIONS	Further study of irreversible EGFR inhibitors should be restricted to patients with activating EGFR mutations .
BACKGROUND	Pfizer .

###26281163
OBJECTIVE	The aim of this study is to assess efficacy and safety of reinforced H. pylori eradication therapy .
METHODS	During 2013-2014 , 40 outpatients were examined .
METHODS	The study included men and women 18-65 y.o.
METHODS	They have been devided in to 2 group by randomized choice ( 20 patients in each group ) .
METHODS	Patients were treated with the reinforced H. pylori eradication therapy : PPI ( 40 mg , / q12h ) , clarithromycin ( 500mg/q12h ) , amoxicillin ( 1000 mg/q12h ) , bismuth subcitrate ( 240 mg/q12h ) for 10 days .
METHODS	The first group given bismuth subcitrate -- De-Nol , the second group given Novobismol .
METHODS	Eradication was confirmed by a 13C-urea breath test and monoclonal stool antigen test 6-8 weeks after therapy .
RESULTS	A total of 34 patients underwent eradication treatment .
RESULTS	Two were lost to follow-up ( one patient in each group ) , four patients ( two patients in each group ) did not complete treatment due to adverse events .
RESULTS	The eradication rates were 97.1 % ( 95 % CI , 88.9 % -100.0 % ) by per-protocol ( PP ) and 82.5 % ( 95 % CI , 69.4 % - 92.5 % ) by intention-to-treat ( ITT ) in the two groups .
RESULTS	The ITT analyses resulted in rates of 85 % ( 95 % CI , 66.5-96 .9 ) for the 10-d reinforced therapy with DeNol and was 80 % ( 95 % CI : 60.2-94 .1 ) for the 10-d reinforced therapy with Novobismol ( P = 0.68 ) , while the PP analyses resulted in 100 % ( 95 % CI , 94.5-100 .0 ) and 94.1 % ( 95 % CI : 78.3-99 .9 ) , respectively ( P = 0.31 ) .
CONCLUSIONS	The reinforced H. pylori eradication therapy ( 10-day high-dose PPI bismuth-containing standard triple therapy ) achieves a significantly high eradication rates in patients with H. pylori - associated diseases .
CONCLUSIONS	Both drugs ( De - Nol and Novobismol ) are both effective and safe for the first-line eradication of H. pylori .

###24244272
BACKGROUND	Emergency department discharge instructions are variably understood by patients , and in the setting of emergency department crowding , innovations are needed to counteract shortened interaction times with the physician .
BACKGROUND	We evaluated the effect of viewing an online video of diagnosis-specific discharge instructions on patient comprehension and recall of instructions .
METHODS	In this prospective , single-center , randomized controlled trial conducted between November 2011 and January 2012 , we randomized emergency department patients who were discharged with one of 38 diagnoses to either view ( after they left the emergency department ) a vetted online video of diagnosis-specific discharge instructions , or to usual care .
METHODS	Patients were subsequently contacted by telephone and asked three standardized questions about their discharge instructions ; one point was awarded for each correct answer .
METHODS	Using an intention-to-treat analysis , differences between groups were assessed using univariate testing , and with logistic regression that accounted for clustering on managing physician .
METHODS	A secondary outcome measure was patient satisfaction with the videos , on a 10-point scale .
RESULTS	Among 133 patients enrolled , mean age was 46.1 ( s.d.D. 21.5 ) and 55 % were female .
RESULTS	Patients in the video group had 19 % higher mean scores ( 2.5 , s.d. 0.7 ) than patients in the control group ( 2.1 , s.d. 0.8 ) ( p = 0.002 ) .
RESULTS	After adjustment for patient age , sex , first language , triage acuity score , and clustering , the odds of achieving a fully correct score ( 3 out of 3 ) were 3.5 ( 95 % CI , 1.7 to 7.2 ) times higher in the video group , compared to the control group .
RESULTS	Among those who viewed the videos , median rating of the videos was 10 ( IQR 8 to 10 ) .
CONCLUSIONS	In this single-center trial , patients who viewed an online video of their discharge instructions scored higher on their understanding of key concepts around their diagnosis and subsequent care .
CONCLUSIONS	Those who viewed the videos found them to be a helpful addition to standard care .
BACKGROUND	ClinicalTrials.gov NCT01361932 http://clinicaltrials.gov/ct2/show/NCT01361932?term=nct01361932&rank=1 .

###25558638
OBJECTIVE	Anesthesiologists have encountered various difficulties in securing the airway .
OBJECTIVE	Therefore , we compare the intubation times and hemodynamic changes between the McGrath Series 5 video laryngoscope and the Macintosh laryngoscope .
METHODS	A total of 80 obstetric patients were divided into 2 groups , orotracheally intubated with either the McGrath video laryngoscope or the Macintosh laryngoscope .
METHODS	The intubation times , Cormack-Lehane grade , percentage of glottic opening , mean arterial blood pressure , and heart rates were compared among the groups .
RESULTS	Intubation time in the McGrath video laryngoscope group was significantly longer than in the Macintosh laryngoscope group ( P < 0.01 ) .
RESULTS	The percentage of glottic opening was found to be higher in the McGrath video laryngoscope group ( P = 0.002 ) .
CONCLUSIONS	The McGrath Series 5 video laryngoscope provides excellent views during orotracheal intubation in obstetric anesthesia with normal airways .

###25294104
BACKGROUND	Smoking-related cues can trigger drug-seeking behaviors , and computer-based interventions that reduce cognitive biases towards such cues may be efficacious and cost-effective cessation aids .
BACKGROUND	In order to optimize such interventions , there needs to be better understanding of the mechanisms underlying the effects of cognitive bias modification ( CBM ) .
BACKGROUND	Here we present a protocol for an investigation of the neural effects of CBM and varenicline in non-quitting daily smokers .
METHODS	We will recruit 72 daily smokers who report smoking at least 10 manufactured cigarettes or 15 roll-ups per day and who smoke within one hour of waking .
METHODS	Participants will attend two sessions approximately one week apart .
METHODS	At the first session participants will be screened for eligibility and randomized to receive either varenicline or a placebo over a seven-day period .
METHODS	On the final drug-taking day ( day seven ) participants will attend a second session and be further randomized to one of three CBM conditions ( training towards smoking cues , training away from smoking cues , or control training ) .
METHODS	Participants will then undergo a functional magnetic resonance imaging scan during which they will view smoking-related pictorial cues .
METHODS	Primary outcome measures are changes in cognitive bias as measured by the visual dot-probe task , and neural responses to smoking-related cues .
METHODS	Secondary outcome measures will be cognitive bias as measured by a transfer task ( modified Stroop test of smoking-related cognitive bias ) and subjective mood and cigarette craving .
CONCLUSIONS	This study will add to the relatively small literature examining the effects of CBM in addictions .
CONCLUSIONS	It will address novel questions regarding the neural effects of CBM .
CONCLUSIONS	It will also investigate whether varenicline treatment alters neural response to smoking-related cues .
CONCLUSIONS	These findings will inform future research that can develop behavioral treatments that target relapse prevention .
BACKGROUND	Registered with Current Controlled Trials : ISRCTN65690030 .
BACKGROUND	Registered on 30 January 2014 .

###25873151
BACKGROUND	Total hip arthroplasty ( THA ) is an increasingly common treatment for older patients with hip osteoarthritis .
BACKGROUND	The best strategy for a physiotherapy intervention for older people after THA is not clear in the literature .
BACKGROUND	The purpose of this protocol study is to test the feasibility of undertaking a full trial clinical to evaluate the effect of ergometer cycling-associated conventional exercises on functional results and health-related quality of life ( HRQOL ) of older patients with THA .
METHODS	This study protocol is a prospective , single center , randomized controlled pilot clinical trial .
METHODS	Older patients ( 60 years ) in the postoperative phase after primary unilateral THA for hip osteoarthritis will be consecutively recruited for this study and randomly allocated to 2 treatment groups .
METHODS	Group I will perform cycle ergometer and conventional exercises , and group II will perform only conventional exercises .
METHODS	The sessions will be conducted twice a week for 8 weeks .
METHODS	Assessments will be made at baseline ( 2 weeks postoperatively : the moment that the patients receive a referral for physical therapy , which will start after suture removal ) , after intervention ( 10 weeks postoperatively ) , and at 6 months of follow-up ( 24 weeks postoperatively ) .
METHODS	The primary outcomes are the function , evaluated using the Harris Hip Score ( HHS ) and the Short Physical Performance Battery ( SPPB ) .
METHODS	The secondary outcome is HRQOL , measured using 2 evaluation instruments : the Medical Outcomes Study 36-Item Short-Form Health Survey ( SF-36 ) and the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) .
METHODS	Data collectors will be blinded and will not have contact with participants during the interventions .
CONCLUSIONS	This randomized controlled trial will provide evidence regarding the effect of this exercise therapy on physical function and quality of life in older patients after THA .
CONCLUSIONS	If our hypothesis is correct , both interventions will be effective , but the exercises on the cycle ergometer conferring better results in function , physical performance and quality of life .
CONCLUSIONS	The study follows Consolidated Standards of Reporting Trials ( CONSORT ) guidelines , and the approval of the local ethics committee has been obtained .
BACKGROUND	ClinicalTrials.gov : NCT01622465 ( 14 June 2012 ) .

###25148789
OBJECTIVE	To examine the effects of intravitreal ranibizumab ( Lucentis ; Genentech , Inc. , South San Francisco , CA ) treatment on patient-reported vision-related function , as assessed by 25-item National Eye Institute Visual Function Questionnaire ( NEI VFQ-25 ) scores , in patients with visual impairment secondary to center-involved diabetic macular edema ( DME ) .
METHODS	Within 2 randomized , double-masked , phase 3 clinical trials ( RIDE [ A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema { ME } With Center Involvement Secondary to Diabetes Mellitus ; NCT00473382 ] and RISE [ A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema { ME } With Center Involvement Secondary to Diabetes Mellitus ; NCT00473330 ] ) , the NEI VFQ-25 was administered at baseline and at the 6 - , 12 - , 18 - , and 24-month follow-up visits .
METHODS	Three hundred eighty-two ( 100 % ) RIDE patients and 377 ( 100 % ) RISE patients .
METHODS	Patients were randomized 1:1:1 to monthly injections of intravitreal ranibizumab 0.3 or 0.5 mg or sham .
METHODS	Study participants could receive macular laser for DME from month 3 onward if specific criteria were met .
METHODS	Exploratory post hoc analysis of mean change from baseline in NEI VFQ-25 scores at 12 and 24 months .
RESULTS	Across all treatment arms , 13 % to 28 % of enrolled eyes were the better-seeing eye .
RESULTS	For all eyes in RIDE and RISE , the mean change in NEI VFQ-25 composite score improved more in ranibizumab-treated eyes at both the 12 - and 24-month visits compared with sham treatment .
RESULTS	For the better-seeing eyes at baseline , the mean change in composite score with 0.3 mg ranibizumab at the 24-month visit was 10.9 more ( 95 % confidence interval [ CI ] , 2.5-19 .2 ) than sham for RIDE patients and 1.3 more ( 95 % CI,-10 .5 to 13.0 ) than sham for RISE patients .
RESULTS	For the worse-seeing eyes at baseline , the mean change in composite score with 0.3 mg ranibizumab at the 24-month visit was 1.0 more ( 95 % CI,-4 .7 to 6.7 ) than sham for RIDE patients and 1.8 more ( 95 % CI,-2 .7 to 6.2 ) than sham for RISE patients .
RESULTS	Similar results for most of these outcomes were seen with 0.5 mg ranibizumab .
CONCLUSIONS	These phase 3 trials demonstrated that ranibizumab treatment for DME likely improves patient-reported vision-related function outcomes compared with sham , further supporting treatment of DME with ranibizumab .

###24901757
OBJECTIVE	Robot-aided exercise therapy is a promising approach to enhance walking ability in stroke survivors .
OBJECTIVE	This study was designed to test a new robotic knee brace for restoring mobility in stroke survivors .
METHODS	Twenty-four ambulatory individuals with chronic hemiparesis after stroke were enrolled in this pilot study .
METHODS	The participants were randomly assigned in equal numbers to either treatment with the experimental device or to a group exercise program and received a total of 18 hrs of their assigned therapy during a 6-wk training period .
METHODS	The primary outcome was gait velocity , as measured with the 10-m walk test .
METHODS	Secondary measures included 6-min walk test , Timed Up and Go test , Five-Times-Sit-to-Stand test , Romberg test , Emory Functional Ambulation Profile , Berg Balance scale , and the California Functional Evaluation 40 .
RESULTS	Twenty subjects completed the entire protocol and all follow-up visits .
RESULTS	No significant differences between the two groups were found for the primary outcome measure at either the completion of training ( week 6 ) or at the 3-mo follow-up ( week 19 ) , with inconsistent findings for secondary measures .
RESULTS	No within-group changes were seen in the primary outcome measure ( 10-m walk test ) in either group .
RESULTS	Within-group improvements were seen in several of the secondary measures for both groups .
RESULTS	No complications of robotic therapy were observed .
CONCLUSIONS	Robotic therapy for ambulatory stroke patients with chronic hemiparesis using a robotic knee brace resulted in only modest functional benefits that were comparable with a group exercise intervention .

###26106009
BACKGROUND	Apixaban is approved for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation .
BACKGROUND	However , the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation ( ARISTOTLE ) trial included a substantial number of patients with valvular heart disease and only excluded patients with clinically significant mitral stenosis or mechanical prosthetic heart valves .
RESULTS	We compared the effect of apixaban and warfarin on rates of stroke or systemic embolism , major bleeding , and death in patients with and without moderate or severe valvular heart disease using Cox proportional hazards modeling .
RESULTS	Of the 18201 patients enrolled in ARISTOTLE , 4808 ( 26.4 % ) had a history of moderate or severe valvular heart disease or previous valve surgery .
RESULTS	Patients with valvular heart disease had higher rates of stroke or systemic embolism and bleeding than patients without valvular heart disease .
RESULTS	There was no evidence of a differential effect of apixaban over warfarin in patients with and without valvular heart disease in reducing stroke and systemic embolism ( hazard ratio [ HR ] , 0.70 ; 95 % confidence interval [ CI ] , 0.51-0 .97 and HR , 0.84 ; 95 % , CI 0.67-1 .04 ; interaction P = 0.38 ) , causing less major bleeding ( HR , 0.79 ; 95 % CI , 0.61-1 .04 and HR , 0.65 ; 95 % CI , 0.55-0 .77 ; interaction P = 0.23 ) , and reducing mortality ( HR , 1.01 ; 95 % CI , 0.84-1 .22 and HR , 0.84 ; 95 % CI , 0.73-0 .96 ; interaction P = 0.10 ) .
CONCLUSIONS	More than a quarter of the patients in ARISTOTLE with nonvalvular atrial fibrillation had moderate or severe valvular heart disease .
CONCLUSIONS	There was no evidence of a differential effect of apixaban over warfarin in reducing stroke or systemic embolism , causing less bleeding , and reducing death in patients with and without valvular heart disease .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00412984 .

###25733201
OBJECTIVE	Prior studies have reported that elevated concentrations of several plasma amino acids ( AA ) , particularly branched chain ( BCAA ) and aromatic AA predict the onset of type 2 diabetes .
OBJECTIVE	We sought to test the hypothesis that circulating BCAA , aromatic AA and related AA metabolites decline in response to the use of insulin sensitizing agents in overweight/obese adults with impaired fasting glucose or untreated diabetes .
METHODS	We performed a secondary analysis of a randomized , double-blind , placebo , controlled study conducted in twenty five overweight/obese ( BMI ~ 30kg/m ( 2 ) ) adults with impaired fasting glucose or untreated diabetes .
METHODS	Participants were randomized to three months of pioglitazone ( 45mg per day ) plus metformin ( 1000mg twice per day , N = 12 participants ) or placebo ( N = 13 ) .
METHODS	We measured insulin sensitivity by the euglycemic-hyperinsulinemic clamp and fasting concentrations of AA and AA metabolites using ultra-pressure liquid chromatography tandem mass spectrometry before and after the three-month intervention .
RESULTS	Insulin sensitizer therapy that significantly enhanced insulin sensitivity reduced 9 out of 33 AA and AA metabolites measured compared to placebo treatment .
RESULTS	Moreover , insulin sensitizer therapy significantly reduced three functionally clustered AA and metabolite pairs : i ) phenylalanine/tyrosine , ii ) citrulline/arginine , and iii ) lysine / - aminoadipic acid .
CONCLUSIONS	Reductions in plasma concentrations of several AA and AA metabolites in response to three months of insulin sensitizer therapy support the concept that reduced insulin sensitivity alters AA and AA metabolites .

###26480551
OBJECTIVE	To compare the clinical efficacy difference in dysantonomia between transcutaneous electrical stimulation at Renying ( ST 9 ) combined with stellate ganglion block ( SGB ) and simple SGB .
METHODS	Sixty patients in accord with the diagnostic criteria of dysantonomia were randomly divided into two groups ,30 cases in each group .
METHODS	In the observation group , transcutaneous electrical stimulation at Renying ( ST 9 ) combined with SGB were adopted ; in the control group , simple SGB was applied .
METHODS	In the two groups , treatment was used three times a week , and nine treatments were considered as one course .
METHODS	There was an interval of one week between courses , and two courses were treated .
METHODS	Total seven weeks were required .
METHODS	Scores were evaluated according to subjective symptoms before treatment , one month and three months after treatment in the two groups .
RESULTS	The scores of subjective symptoms were not statistically different before treatment in the two groups ( P > 0.05 ) .
RESULTS	The scores of subjective symptoms one month and three months after treatment were all lower than those before treatment ( all P < 0.01 ) , and subjective symptoms scores in the observation group were lower than those in the control group ( both P < 0.01 ) .
CONCLUSIONS	Transcutaneous electrical stimulation at Renying ( ST 9 ) combined with SGB could obviously enhance the clinical effects for dysantonomia , and the control and improvement for clinical symptoms are apparently superior to simple SGB .

###25370731
BACKGROUND	Patients with subocclusive Crohn 's disease ( CD ) who received azathioprine ( AZA ) therapy had lower re-hospitalization rates due to all causes and for surgical management of CD compared to those treated with mesalazine during a 3-year period .
BACKGROUND	We investigated whether AZA also was effective for prevention of recurrent bowel obstruction .
METHODS	Rates of recurrent bowel occlusion were compared between patients treated with AZA and those treated with mesalazine .
METHODS	We assessed the time interval-off intestinal obstruction as well as the occlusion-free survival for both groups .
RESULTS	There was a significantly lower cumulative rate of patients with recurrent subocclusion in the AZA group ( 56 % ) compared with the mesalazine group ( 79 % ; OR 3.34 , 95 % CI 1.67-8 .6 ; P = 0.003 ) , with the number needed to treat in order to prevent 1 subocclusion episode of 3.7 favoring AZA .
RESULTS	The occlusion-free time interval was longer in the AZA group compared with the mesalazine group ( 28.8 vs. 18.3 months ; P = 0.000 ) .
RESULTS	The occlusion-free survival at 12 , 24 , and 36 months was significantly higher in the AZA group ( 91 % , 81 % , and 72 % , respectively ) than in the mesalazine group ( 64.7 % , 35.3 % , and 23.5 % , respectively ; P < 0.05 for all comparisons ) .
CONCLUSIONS	In an exploratory analysis of patients with subocclusive ileocecal CD , maintenance therapy with AZA is more effective than mesalazine for eliminating or postponing recurrent intestinal obstruction during 3 years of therapy .

###24326799
OBJECTIVE	This comparative study was aimed at determining the effectiveness of oral Misoprostol compared with intravenous Ergometrine and intravenous Oxytocin in reducing vaginal bleeding following surgical evacuation for first trimester abortions .
METHODS	This was a single-blind placebo-controlled study in which patients with first trimester uncomplicated abortions were divided into three groups using computer-generated randomization table .
METHODS	The first group was administered oral Misoprostol , the second group had intravenous Ergometrine , and the third group was administered intravenous Oxytocin .
METHODS	The uterotonic agents were administered before the surgical evacuation was carried out .
RESULTS	There was statistically significant reduction in blood loss after the evacuation in the Misoprostol group ( P < 0.000 ) .
RESULTS	There was also significant reduction in the number of days of bleeding in the Misoprostol group ( 2.00 0.86 ) compared with 4.43 0.92 and 4.64 1.06 days in the Ergometrine and Oxytocin groups , respectively ( P < 0.000 ) .
RESULTS	There were , however , more gastrointestinal side effects in the Misoprostol and Ergometrine groups ( 60.7 % and 57.1 % , respectively ) compared with the Oxytocin group .
CONCLUSIONS	Oral Misoprostol appeared to demonstrate superior efficacy in reducing uterine bleeding after surgical evacuation , compared to the other commonly used uterotonic agents .

###24401930
BACKGROUND	Data on preoperative chemotherapy in resectable oral cavity cancer are conflicting .
BACKGROUND	We present the long-term results of a randomized trial of induction chemotherapy in resectable oral cavity cancer .
METHODS	A randomized , parallel , multicentre trial evaluated the impact of three cycles of cisplatin 100 mg/m2 and fluorouracil 1000 mg/m2 ( 120-h infusion administered every 21 days ) in stage T2-T4 , N0-N2 , previously untreated patients with advanced disease .
METHODS	Control group received upfront surgery .
METHODS	Postoperative radiation was offered to both arms when pathologic risk features were identified .
METHODS	The co-primary end points were the occurrence of locoregional or distant tumour relapse , and death .
RESULTS	Among the 198 enrolled patients , with a median follow-up of 11.5 years , there was no difference in the incidence of locoregional relapse between chemotherapy and control group ( P = 0.6337 ) , nor in distant metastasis development ( P = 0.1527 ) .
RESULTS	There was also no difference between groups in overall survival ( P = 0.3402 ) .
RESULTS	Patients with a pathological complete response ( pCR ) had higher probability of survival than those without ( 10-year OS : 76.2 % versus 41.3 % , P = 0.0004 ) .
RESULTS	Late toxicities in patients with a minimum follow-up of 60 months ( 42 in each group ) were similar between arms , except from fibrosis ( cumulative incidence 40 % versus 22 % in chemotherapy arm ) and grade 2 dysphagia ( 14 % versus 5 % ) .
CONCLUSIONS	Long-term follow-up of this randomized trial confirmed the absence of survival benefit with preoperative chemotherapy in oral cavity cancer .
CONCLUSIONS	Late toxicity was similar in the two arms except for fibrosis and dysphagia , which were less in the chemotherapy arm .
CONCLUSIONS	The survival benefit for patients achieving a pCR was maintained .

###25098025
OBJECTIVE	To evaluate recombinant human luteinizing hormone ( r-hLH ) versus urine-derived human chorionic gonadotropin ( u-hCG ) to trigger ovulation in women ( aged 20-40 years ) with WHO Group II anovulatory infertility undergoing ovulation induction ( OI ) with recombinant human follicle-stimulating hormone ( r-hFSH ) ( 150 IU/day starting dose ) .
METHODS	For this Phase II , open-label , dose-finding pilot study , patients were randomized to doses of 825 , 2,750 , 5,500 , 11,000 , or 22,000 IU r-hLH or u-hCG ( 5,000 IU ) .
METHODS	Primary endpoints were ovulation and ratio of ruptured follicles/follicle > or = 15 mm ( day of r-hLH / u-hCG administration ) .
METHODS	Secondary endpoints included monofollicular ovulation and clinical pregnancy rates .
RESULTS	All 67 randomized patients completed treatment .
RESULTS	All patients in the r-hLH 2,750 ( 13/13 ) , 5,500 ( 12 / 12 ) , 11,000 IU ( 13/13 ) , and u-hCG 5,000 IU ( 12 / 12 ) groups ovulated ; 3/5 patients in the r-hLH 825 IU and 2/12 in the r-hLH 22,000 IU group failed to ovulate ( p = 0.105 between evaluable groups ) .
RESULTS	The mean ratio of ruptured follicles / follicle > or = 15 mm was 1.1 ( p = 0.675 between groups ) .
RESULTS	The monofollicular ovulation rate was 15/60 ( 25 % ) .
RESULTS	Two cases of ovarian hyperstimulation syndrome were reported .
CONCLUSIONS	This open-label , pilot study ( conducted in 1999-2001 ) suggests that the minimal effective dose of r-hLH to trigger ovulation in women with WHO Group II anovulatory infertility undergoing OI with r-hFSH ( 150 IU starting dose ) was 2,750 IU .

###24792102
OBJECTIVE	To compare intraocular pressure ( IOP ) and wound architecture immediately after cataract surgery using a scleral tunnel incision or clear corneal incision .
METHODS	Prospective randomized clinical trial .
METHODS	Bilateral eyes of 64 patients undergoing phacoemulsification were randomized to 2 groups : 2.4 mm scleral tunnel incision or 2.4 mm clear corneal incision .
METHODS	IOP was adjusted upon completion of surgery to between 15 and 30 mm Hg .
METHODS	The wound was hydrated in 87.5 % of eyes in the clear corneal incision group .
METHODS	IOP was measured using a rebound tonometer preoperatively ; at the conclusion of surgery ; and at 5 , 10 , 15 , 30 , and 60 minutes postoperatively .
METHODS	The Seidel test and anterior segment optical coherence tomography ( AS OCT ) were performed at 30 minutes postoperatively .
RESULTS	In the scleral tunnel incision group , mean IOP decreased to the preoperative level within 15 minutes postoperatively and did not change significantly for up to 60 minutes .
RESULTS	In the clear corneal incision group , IOP decreased to lower than the preoperative IOP at 30 minutes postoperatively .
RESULTS	Mean IOP was significantly higher in the scleral tunnel incision group than in the clear corneal incision group throughout the postoperative period ( P. 0339 ) .
RESULTS	Hypotony ( < 10 mm Hg ) was observed in 7 eyes ( 10.9 % ) that underwent clear corneal incision and in no eyes that underwent scleral tunnel incision ( P = .0131 ) .
RESULTS	Wound leakage and loss of wound coaptation were not observed in any eyes .
CONCLUSIONS	IOP was significantly higher immediately after scleral tunnel incision without hydration than after clear corneal incision with hydration , and both incisions closed within 30 minutes postoperatively without leakage based on AS OCT. .

###25298820
OBJECTIVE	To understand clinician adoption of CDS tools as this may provide important insights for the implementation and dissemination of future CDS tools .
METHODS	Clinicians ( n = 168 ) at a large academic center were randomized into intervention and control arms to assess the impact of strep and pneumonia CDS tools .
METHODS	Intervention arm data were analyzed to examine provider adoption and clinical workflow .
METHODS	Electronic health record data were collected on trigger location , the use of each component and whether an antibiotic , other medication or test was ordered .
METHODS	Frequencies were tabulated and regression analyses were used to determine the association of tool component use and physician orders .
RESULTS	The CDS tool was triggered 586 times over the study period .
RESULTS	Diagnosis was the most frequent workflow trigger of the CDS tool ( 57 % ) as compared to chief complaint ( 30 % ) and diagnosis/antibiotic combinations ( 13 % ) .
RESULTS	Conversely , chief complaint was associated with the highest rate ( 83 % ) of triggers leading to an initiation of the CDS tool ( opening the risk prediction calculator ) .
RESULTS	Similar patterns were noted for initiation of the CDS bundled ordered set and completion of the entire CDS tool pathway .
RESULTS	Completion of risk prediction and bundled order set components were associated with lower rates of antibiotic prescribing ( OR 0.5 ; CI 0.2-1 .2 and OR 0.5 ; CI 0.3-0 .9 , respectively ) .
CONCLUSIONS	Different CDS trigger points in the clinician user workflow lead to substantial variation in downstream use of the CDS tool components .
CONCLUSIONS	These variations were important as they were associated with significant differences in antibiotic ordering .
CONCLUSIONS	These results highlight the importance of workflow integration and flexibility for CDS success .

###25569185
BACKGROUND	Patterns of inhaled 2-agonist therapy use during severe asthma exacerbations before hospital attendance are poorly understood .
OBJECTIVE	To assess 2-agonist use prior to hospital attendance .
METHODS	We undertook an exploratory post hoc analysis of data from a 6-month clinical trial of 303 patients randomised to combination budesonide/formoterol inhaler according to a Single combination inhaler as Maintenance And Reliever Therapy regimen ( ` SMART ' ) or fixed-dose budesonide/formoterol with salbutamol as reliever ( ` Standard ' ) .
METHODS	Patterns of 2-agonist use for 14 days before hospital attendance with a severe asthma exacerbation were determined by electronic monitoring of inhaler use .
RESULTS	There were 22 hospital attendances in 16 patients during the study .
RESULTS	Seven and nine hospital attendances were eligible for analysis in the SMART and Standard groups , respectively .
RESULTS	In both regimens , 2-agonist use increased before hospital attendance , with a median ( range ) maximum daily number of actuations of 14 ( 9 to 63 ) budesonide/formoterol in SMART and 46 ( 6 to 95 ) salbutamol in Standard with 4 ( 0 to 10 ) budesonide/formoterol actuations on the day of maximal salbutamol use .
RESULTS	There was delay in obtaining medical review despite high 2-agonist use , in 9/16 patients .
RESULTS	Different patterns of use were observed , including repeated days of no inhaled corticosteroid despite marked salbutamol use , which occurred in 3/9 patients in the Standard group .
CONCLUSIONS	Delay in obtaining medical review in association with high 2-agonist use is common in patients before hospital presentation with severe exacerbations of asthma .
CONCLUSIONS	The SMART regimen reduced nonadherence with inhaled corticosteroid therapy during severe exacerbations .

###25281437
BACKGROUND	Hypotension is a common problem during spinal anesthesia for cesarean delivery .
BACKGROUND	Intravenous fluid loading is used to correct preoperative dehydration and reduce the incidence and severity of hypotension .
BACKGROUND	Different fluid regimens have been studied but colloid preload and crystalloid co-load have not been compared .
METHODS	In this randomized double-blind study , 210 patients scheduled for elective cesarean section under spinal anesthesia were randomly allocated to receive either 6 % hydroxyethyl starch 130/0 .4 500 mL before spinal anesthesia ( colloid preload ) or Ringer 's acetate solution 1000 mL administered rapidly starting with intrathecal injection ( crystalloid co-load ) .
METHODS	Maternal hypotension ( systolic blood pressure < 80 % of baseline or < 90 mmHg ) and severe hypotension ( systolic blood pressure < 80 mmHg ) were treated with 5 and 10mg ephedrine boluses , respectively .
METHODS	The primary outcome was the incidence of hypotension .
METHODS	Secondary outcomes included the incidence of severe hypotension , total ephedrine dose , nausea and vomiting and neonatal outcome assessed by Apgar scores and umbilical artery blood gas analysis .
RESULTS	Data analysis was performed on 205 patients ; 103 in the colloid preload group and 102 in the crystalloid co-load group .
RESULTS	There were no significant differences in the incidence of hypotension ( 52.4 % vs. 42.2 % ; P = 0.18 ) or severe hypotension ( 15.5 % vs. 9.8 % ; P = 0.31 ) between colloid preload and crystalloid co-load groups , respectively .
RESULTS	The median [ range ] ephedrine dose was 5 [ 0-45 ] mg in the colloid preload group and 0 [ 0-35 ] mg in the crystalloid co-load group ( P = 0.065 ) .
RESULTS	There were no significant differences in maternal nausea or vomiting or neonatal outcomes between groups .
CONCLUSIONS	The use of 1000 mL crystalloid co-load has similar effect to 500 mL colloid preload in reducing the incidence of hypotension after spinal anesthesia for elective cesarean delivery .
CONCLUSIONS	Neither technique can totally prevent hypotension and should be combined with vasopressor use .

###24884563
BACKGROUND	Insight in the natural course of care dependency of vulnerable older persons in long-term care facilities ( LTCF ) is essential to organize and optimize individual tailored care .
BACKGROUND	We examined changes in care dependency in LTCF residents over two 6-month periods , explored the possible predictive factors of change and the effect of care dependency on mortality .
METHODS	A prospective follow-up study in 21 Dutch long-term care facilities .
METHODS	890 LTCF residents , median age 84 ( Interquartile range 79-88 ) years participated .
METHODS	At baseline , 6 and 12 months , care dependency was assessed by the nursing staff with the Care Dependency Scale ( CDS ) , range 15-75 points .
METHODS	Since the median CDS score differed between men and women ( 47.5 vs. 43.0 , P = 0.013 ) , CDS groups ( low , middle and high ) were based on gender-specific 33 % of CDS scores at baseline and 6 months .
RESULTS	At baseline , the CDS groups differed in median length of stay on the ward , urine incontinence and dementia ( all P < 0.001 ) ; participants in the low CDS group stayed longer , had more frequent urine incontinence and more dementia .
RESULTS	They had also the highest mortality rate ( log rank 32.2 ; df = 2 ; P for trend < 0.001 ) .
RESULTS	Per point lower in CDS score , the mortality risk increased with 2 % ( 95 % CI 1 % -3 % ) .
RESULTS	Adjustment for age , gender , cranberry use , LTCF , length of stay , comorbidity and dementia showed similar results .
RESULTS	A one point decrease in CDS score between 0 and 6 months was related to an increased mortality risk of 4 % ( 95 % CI 3 % -6 % ) .
RESULTS	At the 6-month follow-up , 10 % improved to a higher CDS group , 65 % were in the same , and 25 % had deteriorated to a lower CDS group ; a similar pattern emerged at 12-month follow-up .
RESULTS	Gender , age , urine incontinence , dementia , cancer and baseline care dependency status , predicted an increase in care dependency over time .
CONCLUSIONS	The majority of residents were stable in their care dependency status over two subsequent 6-month periods .
CONCLUSIONS	Highly care dependent residents showed an increased mortality risk .
CONCLUSIONS	Awareness of the natural course of care dependency is essential to residents and their formal and informal caregivers when considering therapeutic and end-of-life care options .

###25298411
OBJECTIVE	The purpose of this study was to assess the influence of axial length on spectral-domain optical coherence tomography ( SD-OCT ) thickness measurements in patients with subretinal visual implants .
METHODS	Data from eight emmetropic pseudophakic eyes of eight patients with subretinal visual implants were analyzed retrospectively .
METHODS	These patients participated in the monocentric part of a multicenter trial .
METHODS	The axial length was measured in three short ( < 22.5 mm ) , three medium ( 22.51-25 .50 mm ) , and two long ( > 25.52 mm ) eyes .
METHODS	Using Heidelberg Spectralis , the known thickness of a subretinal implant microchip ( 70 m ) was measured on 15 images per eye with SD-OCT , using the software calipers .
RESULTS	The mean axial length was 20.8 0.8 mm in short eyes , 23.3 0.4 mm in medium eyes , and 26.3 0.5 mm in long eyes .
RESULTS	We found in short eyes , in medium eyes , and in long eyes a mean value of microchip thickness measurements from SD-OCT of 82.9 1.4 m , 70.5 1.3 m , and 64.2 1.3 m , respectively .
RESULTS	The thickness measurements decreased in SD-OCT measurements with longer axial lengths significantly ( P < 0.0001 ) .
CONCLUSIONS	Axial length influences SD-OCT thickness measurements .
CONCLUSIONS	Our findings demonstrate accuracy of the scaling in SD-OCT thickness measurements in emmetropic medium eyes .
CONCLUSIONS	Caution is recommended when comparing the measured values of short and long eyes with the normative database of the instrument .
CONCLUSIONS	There is a need for larger sample-size studies to confirm our results .
CONCLUSIONS	( ClinicalTrials.gov number , NCT01024803 . )

###24447519
BACKGROUND	Renal transplantation is the best treatment for kidney failure , in terms of length and quality of life and cost-effectiveness .
BACKGROUND	However , most transplants fail after 10 to 12 years , consigning patients back onto dialysis .
BACKGROUND	Damage by the immune system accounts for approximately 50 % of failing transplants and it is possible to identify patients at risk by screening for the presence of antibodies against human leukocyte antigens .
BACKGROUND	However , it is not clear how best to treat patients with antibodies .
BACKGROUND	This trial will test a combined screening and treatment protocol in renal transplant recipients .
METHODS	Recipients > 1 year post-transplantation , aged 18 to 70 with an estimated glomerular filtration rate > 30 mL/min will be randomly allocated to blinded or unblinded screening arms , before being screened for the presence of antibodies .
METHODS	In the unblinded arm , test results will be revealed .
METHODS	Those with antibodies will have biomarker-led care , consisting of a change in their anti-rejection drugs to prednisone , tacrolimus and mycophenolate mofetil .
METHODS	In the blinded arm , screening results will be double blinded and all recruits will remain on current therapy ( standard care ) .
METHODS	In both arms , those without antibodies will be retested every 8 months for 3 years .
METHODS	The primary outcome is the 3-year kidney failure rate for the antibody-positive recruits , as measured by initiation of long-term dialysis or re-transplantation , predicted to be approximately 20 % in the standard care group but < 10 % in biomarker-led care .
METHODS	The secondary outcomes include the rate of transplant dysfunction , incidence of infection , cancer and diabetes mellitus , an analysis of adherence with medication and a health economic analysis of the combined screening and treatment protocol .
METHODS	Blood samples will be collected and stored every 4 months and will form the basis of separately funded studies to identify new biomarkers associated with the outcomes .
CONCLUSIONS	We have evidence that the biomarker-led care regime will be effective at preventing graft dysfunction and expect this to feed through to graft survival .
CONCLUSIONS	This trial will confirm the benefit of routine screening and lead to a greater understanding of how to keep kidney transplants working longer .
BACKGROUND	Current Controlled Trials ISRCTN46157828 .

###24243080
BACKGROUND	Venipuncture is one of the most painful events for children in hospitals .
BACKGROUND	Valsalva maneuver ( VM ) decreases the incidence and severity of pain on venipuncture pain in adults .
BACKGROUND	This study was designed to evaluate VM as compared with Eutectic Mixture of Local Anesthetic ( EMLA ( ) ) cream for venipuncture pain in children .
METHODS	In this study , we evaluated the effect of VM on venipuncture pain in children .
METHODS	60 patients scheduled for elective surgery were randomly divided into three groups .
METHODS	In Group V , children were punctured during VM .
METHODS	In Group E , EMLA ( ) 5 % cream and in Group C ( control group ) vaseline was applied on the non-dominant hand 60 min before the venipuncture .
METHODS	Patients made a pain assessment using visual analog score ( VAS ) .
METHODS	Mean arterial pressure ( MAP ) , heart rate ( HR ) , and SpO2 measurements were obtained during the venous cannulation .
RESULTS	Respectively , the VAS was 2.15 1.95 for Group V and 1.00 0.79 for Group E and 2.55 2.74 for Group C.
RESULTS	A significant reduction in the severity of pain was observed in Group E.
RESULTS	The difference being statistically significant ( p < 0.05 ) , the VAS of Group V was higher than Group E but lower than Group C ( p > 0.05 ) .
CONCLUSIONS	On the basis of data from this study , the VM is a simple and a practical method to reduce venipuncture pain in children but not as effectively as EMLA ( ) .

###25443650
OBJECTIVE	Is a combination of standing , electrical stimulation and splinting more effective than standing alone for the management of ankle contractures after severe brain injury ?
METHODS	A multi-centre randomised trial with concealed allocation , assessor blinding and intention-to-treat analysis .
METHODS	Thirty-six adults with severe traumatic brain injury and ankle plantarflexion contractures .
METHODS	All participants underwent a 6-week program .
METHODS	The experimental group received tilt table standing , electrical stimulation and ankle splinting .
METHODS	The control group received tilt table standing alone .
METHODS	The primary outcome was passive ankle dorsiflexion with a 12Nm torque .
METHODS	Secondary outcomes included : passive dorsiflexion with lower torques ( 3 , 5 , 7 and 9Nm ) ; spasticity ; the walking item of the Functional Independence Measure ; walking speed ; global perceived effect of treatment ; and perceived treatment credibility .
METHODS	OUTCOME MEASURES were taken at baseline ( Week 0 ) , end of intervention ( Week 6 ) , and follow-up ( Week 10 ) .
RESULTS	The mean between-group differences ( 95 % CI ) for passive ankle dorsiflexion at Week 6 and Week 10 were -3 degrees ( -8 to 2 ) and -1 degrees ( -6 to 4 ) , respectively , in favour of the control group .
RESULTS	There was a small mean reduction of 1 point in spasticity at Week 6 ( 95 % CI 0.1 to 1.8 ) in favour of the experimental group , but this effect disappeared at Week 10 .
RESULTS	There were no differences for other secondary outcome measures except the physiotherapists ' perceived treatment credibility .
CONCLUSIONS	Tilt table standing with electrical stimulation and splinting is not better than tilt table standing alone for the management of ankle contractures after severe brain injury .
BACKGROUND	ACTRN12608000637347 .
BACKGROUND	[ Leung J , Harvey LA , Moseley AM , Whiteside B , Simpson M , Stroud K ( 2014 ) Standing with electrical stimulation and splinting is no better than standing alone for management of ankle plantarflexion contractures in people with traumatic brain injury : a randomised trial.Journal of Physiotherapy60 : 201-208 ] .

###25261272
BACKGROUND	The purpose of this study was to determine the cost implications of the Coronary Artery Bypass Graft Off or On Pump Revascularization Study ( CORONARY ) at 1 year .
METHODS	Country-specific healthcare costs were obtained from public databases or local experts from each country in the CORONARY trial .
METHODS	Purchasing power parities were applied to these costs of consumed healthcare resources .
METHODS	Analyses of subgroups included in the CORONARY clinical trial were also conducted .
METHODS	Costs are reported in US dollars .
RESULTS	After 1 year , the total cost per patient in the off-pump coronary artery bypass graft surgery ( CABG ) arm was $ 9,650 ( $ 9,216 to $ 10,285 ) compared with $ 9,583 ( $ 9,239 to $ 9,988 ) for the on-pump CABG arm ; that resulted in a nonsignificant increase of $ 68 ( - $ 575 to $ 710 ) .
RESULTS	Similar findings were noted for various subgroups .
RESULTS	There were also no differences due to late conversions .
CONCLUSIONS	The CORONARY trial demonstrated that off-pump CABG was clinically as safe and effective as on-pump CABG with no difference in costs .
CONCLUSIONS	Thus , the decision as to which method to choose is free from costs considerations and should be based on patient preference and surgeon expertise ( Coronary Artery Bypass Graft [ CABG ] Off or On Pump Revascularization Study [ CORONARY ] ; clinicaltrials.gov NCT00463294 ) .

###25499937
BACKGROUND	Statin intolerance has been a major limitation in the use of statins , especially at higher doses .
BACKGROUND	New effective treatments are needed for lowering low-density lipoprotein cholesterol ( LDL-C ) in patients who can not tolerate daily statin doses .
OBJECTIVE	ODYSSEY ALTERNATIVE ( NCT01709513 ) evaluates efficacy and safety of alirocumab , a fully human proprotein convertase subtilisin/kexin type 9 monoclonal antibody , in patients with well-documented statin intolerance and moderate to very high cardiovascular risk .
METHODS	This is a phase 3 , multicenter , randomized , double-blind , double-dummy study in statin-intolerant patients .
METHODS	Intolerance was defined as inability to take at least 2 different statins because of muscle-related adverse events ( AEs ) , 1 at the lowest approved starting dose .
METHODS	Patients first received single-blind subcutaneous and oral placebo for 4 weeks , and were withdrawn if they developed muscle-related AEs after the placebo treatment .
METHODS	Continuing patients were randomized ( 2:2:1 ratio ) to alirocumab 75 mg self-administered via single 1 mL prefilled pen every 2 weeks or ezetimibe 10 mg/day or atorvastatin 20 mg/day ( statin rechallenge ) , for 24 weeks .
METHODS	Alirocumab dose was increased to 150 mg every 2 weeks ( also 1 mL ) at week 12 depending on week 8 LDL-C level .
METHODS	The primary endpoint is percent change in LDL-C from baseline to week 24 by intent-to-treat analysis .
METHODS	Muscle-related AEs were assessed by spontaneous patient reports and clinic queries .
RESULTS	A total of 314 patients have been randomized .
CONCLUSIONS	This is the first and only study of a new class of LDL-C-lowering agents in patients selected with a rigorously documented intolerance to statins , using a placebo run-in and statin control arm .

###24467711
OBJECTIVE	The optimal strategy for the reconstruction of the pancreas following pancreaticoduodenectomy ( PD ) is still debated .
OBJECTIVE	The aim of this study was to compare the outcomes of isolated Roux loop pancreaticojejunostomy ( IRPJ ) with those of pancreaticogastrostomy ( PG ) after PD .
METHODS	Consecutive patients submitted to PD were randomized to either method of reconstruction .
METHODS	The primary outcome measure was the rate of postoperative pancreatic fistula ( POPF ) .
METHODS	Secondary outcomes included operative time , day to resumption of oral feeding , postoperative morbidity and mortality , and exocrine and endocrine pancreatic functions .
RESULTS	Ninety patients treated by PD were included in the study .
RESULTS	The median total operative time was significantly longer in the IRPJ group ( 320min versus 300min ; P = 0.047 ) .
RESULTS	Postoperative pancreatic fistula developed in nine of 45 patients in the IRPJ group and 10 of 45 patients in the PG group ( P = 0.796 ) .
RESULTS	Seven IRPJ patients and four PG patients had POPF of type B or C ( P = 0.710 ) .
RESULTS	Time to resumption of oral feeding was shorter in the IRPJ group ( P = 0.03 ) .
RESULTS	Steatorrhea at 1 year was reported in nine of 42 IRPJ patients and 18 of 41 PG patients ( P = 0.029 ) .
RESULTS	Albumin levels at 1 year were 3.6 g/dl in the IRPJ group and 3.3 g/dl in the PG group ( P = 0.001 ) .
CONCLUSIONS	Isolated Roux loop PJ was not associated with a lower rate of POPF , but was associated with a decrease in the incidence of postoperative steatorrhea .
CONCLUSIONS	The technique allowed for early oral feeding and the maintenance of oral feeding even if POPF developed .

###25433353
OBJECTIVE	The increasing number of patients with implantable cardiac devices raises the need for more efficient outpatient follow-up care .
OBJECTIVE	Due to technological progress in communication and transmission systems and in the implantable devices themselves , telemonitoring can be widely used as an important part of care for patients and devices .
OBJECTIVE	Our objective was to evaluate the benefits of continuous remote monitoring using the BIOTRONIK Home Monitoring ( HM ) system compared to standard outpatient follow-ups .
METHODS	198 patients with single - or dual-chamber implantable cardioverter-defibrillator ( ICD ) implanted for primary or secondary prevention of sudden cardiac death were randomized into a group of patients followed through standard outpatient visits ( HM - ) and a group telemonitored by the HM system ( HM + ) .
METHODS	Planned and emergency visits , ICD-related hospitalizations , and delivered shocks and their appropriateness were evaluated in the respective groups .
RESULTS	A significant reduction was achieved in the number of planned ( by 48 % , p < 0.001 ) and total visits ( by 45 % , p < 0.001 ) during a three-year evaluation .
RESULTS	A comparable number of patients experienced one or more shocks .
RESULTS	Mortality rates were equivalent , as was the number of patients hospitalized in relation to their ICD .
RESULTS	However , there was a significant reduction in the number and proportion of inappropriate shocks delivered in the HM + patient group : by 80 % ( p = 0.002 ) in outpatient follow-up care and by 90 % ( p < 0.001 ) when multiple shocks requiring hospitalization were included .
CONCLUSIONS	The HM system was an effective and safe method of follow-up in patients with an implanted ICD .
CONCLUSIONS	Remote monitoring reduces the number of outpatient visits and inappropriate shocks .

###24379118
BACKGROUND	Recent publications have shown an infection rate of 5-7 % for acetabular fractures treated with the Kocher-Langenbeck ( K-L ) approach .
BACKGROUND	Using metallic staples to close hip skin incisions has been considered the gold standard .
BACKGROUND	The purpose of this study was to answer the following : ( 1 ) will closure of a K-L incision after acetabular fracture surgery with a running subcuticular monocryl suture , then sealing the wound with 2-octyl cyanoacrylate ( OCA ) , result in a lower infection rate compared to metallic staple closure ?
BACKGROUND	( 2 ) Do incisions closed with subcuticular monocryl and OCA exhibit decreased drainage ?
BACKGROUND	( 3 ) Is there a cost difference between these two methods ?
METHODS	In a prospective clinical study , 103 patients with acetabular fractures treated using the K-L approach were randomized into two groups : skin closure with metallic staples ( n = 52 ) versus subcuticular running monocryl suture sealed with OCA ( n = 51 ) .
RESULTS	Two postoperative deep infections ( 4 % ) in the staples group required multiple debridements ; no infections developed in the OCA group .
RESULTS	However , there was no statistical difference between the groups , ( p = 0.495 ) .
RESULTS	There was a statistically significant difference ( p = 0.032 ) comparing days from surgery to a dry incision favoring OCA ( 4.2 versus 5.85 days ) .
RESULTS	The patient charge was approximately $ 900 greater on average in the OCA group due to the increased time in the operating room required for the subcuticular closure .
CONCLUSIONS	Closure with OCA and subcuticular monocryl showed no clinical disadvantages and appears to have a clinical advantage when compared to standard metallic staple skin closure in acetabular fracture surgery .
CONCLUSIONS	However , additional patient costs may be incurred .
METHODS	II .

###24837860
OBJECTIVE	The aim of this work was to investigate cardiorespiratory fitness in breast cancer patients at different time points of anti-cancer treatment .
METHODS	Non-metastatic breast cancer patients ( n = 222 , mean age 55 years ) were categorized into four subgroups according to their treatment status .
METHODS	Cardiopulmonary exercise testing ( CPET ) was used to measure patients ' cardiorespiratory fitness , including oxygen delivery and metabolic muscle function .
METHODS	Testing was performed by bicycle ergometry , and maximal oxygen uptake ( VO2peak ) was measured .
METHODS	Heart rate during exercise at 50 watts ( HR50 ) was assessed as a cardiocirculatory parameter and ventilatory threshold ( VT ) was used as an indicator of the O2 supply to muscle .
METHODS	Analysis of covariance was used to estimate the impact of different cancer treatments on cardiorespiratory fitness with adjustment for clinical factors .
RESULTS	Submaximal measures were successfully assessed in 220 ( 99 % ) and 200 ( 90 % ) patients for HR50 and VT , while criteria for maximal exercise testing were met by 176 patients ( 79 % ) , respectively .
RESULTS	The mean VO2peak was 20.6 6.7 ml/kg/min , mean VT 10.7 2.9 ml/min/kg and mean HR50 112 16 beats/min .
RESULTS	Chemotherapy was significantly associated with decreased VO2peak , with significantly lower adjusted mean VO2peak among patients post adjuvant chemotherapy compared to patients with no chemotherapy or those who just started chemotherapy regime ( all p < 0.01 ) .
RESULTS	Patients post adjuvant chemotherapy reached only 63 % of the VO2peak level expected for their age - and BMI-category ( mean VO2peak 15.5 4.8 ml/kg/min ) .
RESULTS	Similarly , HR50 was significantly associated with treatment .
RESULTS	However , VT was not associated with treatment .
CONCLUSIONS	Breast cancer patients have marked and significantly impaired cardiopulmonary function during and after chemotherapy .
CONCLUSIONS	Hereby , chemotherapy appears to impair cardiorespiratory fitness by influencing the oxygen delivery system rather than impacting metabolic muscle function .
CONCLUSIONS	Our findings underline the need of exercise training in breast cancer patients to counteract the loss of cardiorespiratory fitness during the anti-cancer treatment .

###25523344
BACKGROUND	The treatment of massive pulmonary embolisms with an associated cardiac arrest is controversial ; however , surgical thrombectomy with extracorporeal circulation ( ECC ) is an option for treatment .
BACKGROUND	It is difficult to remove all thromboembolic material .
BACKGROUND	Theoretically , retrograde blood perfusion through the lungs may be beneficial .
OBJECTIVE	To investigate whether retrograde blood perfusion through the lungs during a thrombectomy is beneficial .
METHODS	Twelve pigs were prepared for ECC .
METHODS	Repetitive injections of preformed blood thrombi into the right atrium resulted in cardiac arrests .
METHODS	ECC was established after 10 minutes of cardiac arrest , and after a sternotomy , the main pulmonary artery was incised and as much thrombotic material as possible was removed from the pulmonary arteries .
METHODS	The pigs were randomised to ECC for one hour either with or without retrograde perfusion in the pulmonary circulation .
METHODS	After one hour , the released material was removed from the pulmonary arteries , and the incision was sutured .
METHODS	The pigs were weaned from the ECC .
METHODS	After sacrificing the pigs , they were autopsied with special attention to the amount of remaining thrombi .
METHODS	Additional histological analyses were performed with special attention to microembolisms , atelectases , and signs of tissue damage .
RESULTS	All of the pigs were weaned from the ECC .
RESULTS	The amount of the embolic material removed varied considerably , as did the amount removed after the retrograde or antegrade perfusion , and there was no significant difference between the two treatment modalities .
RESULTS	There were no signs of tissue damage in the lungs .
CONCLUSIONS	Retrograde lung perfusion was not generally beneficial in the treatment of massive pulmonary embolism in this setup ; however , it may be an option if only a modest amount of material is accessible in the pulmonary artery .

###24656727
BACKGROUND	Infantile hemangiomas have a dramatic response to propranolol , a nonselective beta-blocker .
BACKGROUND	However , this treatment is not risk-free and many patients are excluded because of respiratory comorbidities .
BACKGROUND	Atenolol is a cardioselective beta-blocker that may have fewer adverse events .
OBJECTIVE	We sought to evaluate the effectiveness of atenolol against propranolol in a noninferiority trial .
METHODS	In all , 23 patients met the inclusion criteria and were randomized to receive either atenolol or propranolol .
METHODS	Thirteen patients were treated with atenolol and 10 with propranolol .
METHODS	Follow-up was made at baseline , 2 weeks , 4 weeks , and then monthly for 6 months .
RESULTS	Patients treated with atenolol had a complete response of 53.8 % and 60 % with propranolol , respectively .
RESULTS	These results were nonsignificant ( P = .68 ) .
RESULTS	Relevant adverse events were not reported .
CONCLUSIONS	The reduced number of patients could have influenced our results .
CONCLUSIONS	Atenolol appears to be as effective as propranolol .
CONCLUSIONS	We did not find significant differences between these results or any adverse events .

###24593269
BACKGROUND	Erectile dysfunction is prevalent in men over 40 years , affecting their quality of life and that of their partners .
BACKGROUND	The aims of this study were : a ) To evaluate the internal reliability of the male erectile dysfunction specific quality of life ( MED-QoL ) scale and explore its factor structure.b ) To evaluate the effect of simvastatin on subscales of the MED-QoL in men over forty years with erectile dysfunction .
METHODS	This is a double blind randomised controlled trial of 40 mg simvastatin or placebo given once daily for six months to men over forty years with untreated erectile dysfunction , who were not at high cardiovascular risk and were not on anti-hypertensive or lipid-lowering medication .
METHODS	173 eligible men were recruited from 10 general practices in East of England .
METHODS	Data were collected at two points over 30 weeks.We report on the factor structure of MED-QoL , the internal reliability of the scale and the derived subscales , and the effect of simvastatin on MED-QoL subscales .
RESULTS	An initial analysis of the MED-QoL items suggested that a number of items should be removed ( MED-QoL-R ) .
RESULTS	Exploratory factor analysis identified three subscales within the MED-QoL-R which accounted for 96 % of the variance , related to feelings of Control , initiating Intimacy , and Emotional response to erectile dysfunction .
RESULTS	The alpha value for the revised scale ( MED-Qol-R ) was > 0.95 and exceeded .82 for each subscale .
RESULTS	Regression analysis showed that patients in the placebo group experienced a significantly reduced feeling of Control over erectile dysfunction than those in the statin group .
RESULTS	Those in the placebo group had significantly lower Emotional response than those in the statin group at the close of trial , but there was no significant treatment effect on Intimacy .
CONCLUSIONS	Our revised MED-QoL-R identified three subscales .
CONCLUSIONS	Secondary analysis showed a significant improvement in sexual health related quality of life , specifically in relation to perception of control and emotional health in men with untreated erectile dysfunction given 40 mg simvastatin for six months .
BACKGROUND	Current Controlled Trials ISRCTN66772971 .

###25821098
BACKGROUND	A high dose of continuous intravenous infusion of proton pump inhibitor ( PPI ) is the standard treatment for peptic ulcer bleeding .
BACKGROUND	The optimal dose for the prevention of bleeding after endoscopic submucosal dissection ( ESD ) is unclear .
OBJECTIVE	The purpose of this study was to determine whether stronger acid suppression more effectively prevents bleeding and high risk ulcer stigma ( HRS ) after gastric ESD .
METHODS	A total of 273 patients who underwent ESD were randomly assigned to one of two treatment groups : the continuous infusion group and the bolus injection group .
METHODS	Second-look endoscopy was performed on the following day after ESD .
METHODS	The incidences and risk factors of HRS identified by second-look endoscopy and delayed bleeding were analyzed .
RESULTS	There were no differences in the incidences of HRS and delayed bleeding between two treatment groups .
RESULTS	The incidence of HRS was 15.8 % ( 43/273 ) and the gross morphology ( flat or depressed ) was identified as a significant factor associated with HRS .
RESULTS	The incidence of delayed bleeding was 8.4 % ( 23/273 ) and the gross morphology ( flat ) and the presence of submucosal invasive cancer were identified as the associated risk factors for delayed bleeding .
CONCLUSIONS	The incidences of delayed bleeding and HRS identified by second-look endoscopy were not affected by PPI infusion methods .
CONCLUSIONS	Flat or depressed morphologic lesions and submucosal invasive cancer should be closely monitored .

###25219475
OBJECTIVE	Ultrasound ( US ) - guided needling with subacromial corticosteroid injection is more effective than extracorporeal shock wave therapy ( ESWT ) for function restoration and pain relief in patients with calcific tendinitis of the shoulder .
METHODS	Fifty-four patients diagnosed with unilateral painful calcific tendinitis were randomly allocated to a US needling or ESWT group .
METHODS	The US needling group underwent US-guided needling and received a subacromial corticosteroid injection .
METHODS	The ESWT group received ESWT 3 times a week .
METHODS	All patients were prospectively evaluated ; American Shoulder and Elbow Surgeons , Simple Shoulder Test , and visual analog scale for pain scores were recorded before the procedure and at 6 weeks , 12 weeks , 6 months , 12 months , and the last follow-up .
METHODS	The size and morphology of the deposits were evaluated by radiography .
RESULTS	The average follow-up period was 23.0 months .
RESULTS	At last follow-up , the mean size of the deposits was significantly different between the 2 groups ( P = .001 ) ; it decreased to 0.5 mm from 14.8 mm in the US needling group and to 5.6 mm from 11.0 mm in the ESWT group .
RESULTS	There were also significant improvements in clinical outcomes in both groups after treatment ( P < .05 ) .
RESULTS	At 1-year follow-up , the US needling group had significantly better scores than the ESWT group with regard to the American Shoulder and Elbow Surgeons assessment ( 90.3 and 74.6 , respectively ; P = .001 ) , Simple Shoulder Test ( 83.3 and 70.8 , respectively ; P = .015 ) , and visual analog scale for pain ( 1.4 and 3.3 , respectively ; P = .003 ) .
RESULTS	The initial calcium deposit sizes and clinical outcomes were weakly correlated in both groups ( P > .05 ) .
CONCLUSIONS	Both treatment modalities for calcific tendinitis improved clinical outcomes and eliminated calcium deposits .
CONCLUSIONS	US-guided needling treatment , however , was more effective in function restoration and pain relief in the short term .

###24977398
OBJECTIVE	Meta-analyses suggest that an intravenous bolus or a high dose continuous infusion of somatostatin reduces the incidence of acute pancreatitis after endoscopic retrograde cholangiopancreatography ( ERCP ) .
OBJECTIVE	Clinical guidelines , however , do not recommend this prophylaxis .
OBJECTIVE	The aim of this randomized , double-blind clinical trial was to evaluate the effect of somatostatin on the incidence of post-ERCP pancreatitis .
METHODS	Patients undergoing ERCP at a single center were randomized to either intravenous bolus of somatostatin followed by a short ( 4-hour ) continuous infusion , or to a similar placebo regimen .
METHODS	The primary outcome was post-ERCP pancreatitis , defined as abdominal pain with an amylase level at least three times higher than the upper limit of normality 24 hours after the ERCP and requiring admission for at least 2 days .
RESULTS	A total of 510 patients were enrolled ( 255 patients per group ) and all completed follow-up .
RESULTS	The main indications for ERCP were choledocholithiasis ( 62 % ) , and biliary malignant stricture ( 31 % ) .
RESULTS	Post-ERCP pancreatitis occurred in 19 patients ( 7.5 % ) in the somatostatin group and 17 patients ( 6.7 % ) in the placebo group ( relative risk [ RR ] 1.12 , 95 % confidence interval [ 95 % CI ] 0.59-2 .1 ; P = 0.73 ) .
RESULTS	The number of cases of moderate or severe acute pancreatitis was similar in the somatostatin ( 2.4 % ) and the placebo ( 3.5 % ) groups ( RR 0.67 , 95 % CI 0.24-1 .85 , P = 0.43 ) .
RESULTS	No side effects were observed related to the use of somatostatin .
CONCLUSIONS	Administration of an intravenous bolus of somatostatin followed by a short continuous infusion does not reduce the incidence of post-ERCP pancreatitis .
CONCLUSIONS	Clinical Trials.gov number : NCT01060826 .

###25777307
OBJECTIVE	Prospective data to examine the association of homocysteine with age-related macular degeneration ( AMD ) are limited .
OBJECTIVE	We examined the prospective relation of plasma homocysteine level and AMD in a large cohort of apparently healthy women .
METHODS	We evaluated the relationship between baseline levels of plasma homocysteine and incident AMD among 27,479 female health professionals aged 40 years or older .
METHODS	Main outcome measures were total AMD , defined as self-report documented by medical record evidence of an initial diagnosis after randomization , and visually significant AMD , defined as confirmed incident AMD with visual acuity 20/30 or worse attributable to this condition .
RESULTS	During an average 10 years of follow-up , a total of 452 cases of AMD , including 182 cases of visually significant AMD , were documented .
RESULTS	Women in the highest versus lowest quartile of plasma homocysteine had modestly , but statistically non-significant , increased risks of total AMD ( hazard ratio , HR , 1.24 , 95 % confidence interval , CI , 0.95-1 .63 ; p for trend 0.07 ) and visually significant AMD ( HR 1.41 , 95 % CI 0.92-2 .17 ; p for trend 0.052 ) in age - and treatment-adjusted analyses .
CONCLUSIONS	These prospective data from a large cohort of apparently healthy women do not support a strong role for homocysteine in AMD occurrence .

###25517204
BACKGROUND	The number of therapeutic drugs available for the treatment of alcohol use disorders ( AUDs ) is limited , and a well-tolerated , self-administrable drug is much needed .
BACKGROUND	Subgroups of alcohol-dependent individuals , for example , individuals with heredity for AUD , may respond differently to pharmacological treatments , particularly to drugs affecting the serotonergic system in the brain .
BACKGROUND	Clinical observations and case reports indicate that mirtazapine , a widely used and well-tolerated antidepressant drug , which increases both noradrenaline and serotonin release but simultaneously blocks serotonergic ( 5-hydroxytryptamine ) 3 receptors , reduces alcohol consumption .
BACKGROUND	Moreover , drugs affecting serotonergic ( 5-hydroxytryptamine ) 3 receptors have been shown to work differently in individuals with heredity for AUD .
METHODS	This double-blind , randomized , placebo-controlled , 2-armed clinical trial aimed to establish whether mirtazapine lowers alcohol consumption in male high consumers .
METHODS	The study population was also subgrouped in accordance with heredity for AUD .
METHODS	After 2 lead-in weeks of single-blind placebo , 59 males were randomly assigned to receive 8 weeks of treatment with 30-mg mirtazapine daily ( n = 29 ) or placebo ( n = 30 ) .
METHODS	The main outcome was self-reported alcohol consumption ( drinks per day ) measured by an alcohol diary .
METHODS	The alcohol consumption was calculated as weekly mean during the study period compared with baseline .
METHODS	The data were analyzed in accordance with intention to treat and per protocol .
RESULTS	The results suggest that high consumers of alcohol with a heredity for AUD benefit from treatment with mirtazapine .
CONCLUSIONS	The results of this study did not support an advantage of mirtazapine over placebo on alcohol consumption in the intention-to-treat analysis .
CONCLUSIONS	However , mirtazapine could be an alternative to available treatments for alcohol dependence in patients with heredity for AUD .

###24445757
OBJECTIVE	This study assessed the efficacy of methylphenidate versus placebo for cancer-related fatigue reduction .
OBJECTIVE	Other objectives were to analyze cytokine levels and to determine the effects of methylphenidate on other symptoms , cognitive function , work yield , and patients ' perceptions and preferences .
METHODS	Patients were randomly assigned ( 1:1 ) to receive methylphenidate-placebo or placebo-methylphenidate for 4 weeks .
METHODS	Patients crossed over after 2 weeks .
METHODS	Wilcoxon signed rank tests and McNemar tests were used to assess continuous and categorical variables .
METHODS	The primary efficacy endpoint was change in the level of worst fatigue on the Brief Fatigue Inventory ( BFI ) at the end of each 2-week period .
RESULTS	The mean baseline BFI score was moderate ( 5.7 ) .
RESULTS	Methylphenidate treatment did not affect patients ' worst level of fatigue or other symptoms .
RESULTS	Results from the Wechsler Adult Intelligence Scale Digit Symbol Test and the Hopkins Verbal Learning Test with BFI interference questions and BFI activity questions showed significant improvement in the methylphenidate-treated patients ' verbal learning , memory , visual perception , analysis , and scanning speed .
RESULTS	Patients treated with methylphenidate missed significantly fewer work hours owing to health reasons and worked significantly more hours .
RESULTS	After 4 weeks , 64 % of patients reported that methylphenidate improved their cancer-related fatigue , and 58 % wanted to continue treatment .
RESULTS	Significant difference in interleukin 6R ( positive ) , interleukin 10 ( negative ) , and tumor necrosis factor ( positive ) was noted between the methylphenidate and the placebo group .
CONCLUSIONS	Low-dose methylphenidate did not improve cancer-related fatigue .
CONCLUSIONS	Patients taking methylphenidate had better cognition and were able to work more hours .
CONCLUSIONS	Patients tolerated methylphenidate well , and the majority felt better and wanted to continue treatment .

###25204295
BACKGROUND	A randomized study in 1999-2005 of mechanical bowel preparation ( MBP ) preceding colonic resection found no decrease in postoperative complications .
BACKGROUND	The aim of the present study was to evaluate the long-term effect of MBP regarding cancer recurrence and survival after colonic resections .
METHODS	The cohort of patients with colonic cancer in the MBP study was followed up for 10 years .
METHODS	Data were collected from registers run by the National Board of Health and Welfare .
METHODS	Register data were validated against information in patient charts .
METHODS	Cox proportional hazards model was used for multivariable analysis of factors predictive of cancer-specific survival .
RESULTS	Register analysis showed significantly fewer recurrences , and better cancer-specific and overall survival in the MBP group .
RESULTS	After validation , 839 of 1343 patients remained for analysis ( 448 MBP , 391 no MBP ) .
RESULTS	Eighty ( 179 per cent ) of 448 patients in the MBP group and 88 ( 225 per cent ) of 391 in the no-MBP group developed a cancer recurrence ( P = 0093 ) .
RESULTS	The 10-year cancer-specific survival rate was 841 per cent in the MBP group and 780 per cent in the no-MBP group ( P = 0019 ) .
RESULTS	Overall survival rates were 588 and 560 per cent respectively ( P = 0186 ) .
CONCLUSIONS	Patients receiving MBP before elective colonic cancer surgery had significantly better cancer-specific survival after 10 years .

###24382580
BACKGROUND	Arm hemiparesis secondary to stroke is common and disabling .
BACKGROUND	We aimed to assess whether robotic training of an affected arm with ARMin -- an exoskeleton robot that allows task-specific training in three dimensions-reduces motor impairment more effectively than does conventional therapy .
METHODS	In a prospective , multicentre , parallel-group randomised trial , we enrolled patients who had had motor impairment for more than 6 months and moderate-to-severe arm paresis after a cerebrovascular accident who met our eligibility criteria from four centres in Switzerland .
METHODS	Eligible patients were randomly assigned ( 1:1 ) to receive robotic or conventional therapy using a centre-stratified randomisation procedure .
METHODS	For both groups , therapy was given for at least 45 min three times a week for 8 weeks ( total 24 sessions ) .
METHODS	The primary outcome was change in score on the arm ( upper extremity ) section of the Fugl-Meyer assessment ( FMA-UE ) .
METHODS	Assessors tested patients immediately before therapy , after 4 weeks of therapy , at the end of therapy , and 16 weeks and 34 weeks after start of therapy .
METHODS	Assessors were masked to treatment allocation , but patients , therapists , and data analysts were unmasked .
METHODS	Analyses were by modified intention to treat .
METHODS	This study is registered with ClinicalTrials.gov , number NCT00719433 .
RESULTS	Between May 4 , 2009 , and Sept 3 , 2012 , 143 individuals were tested for eligibility , of whom 77 were eligible and agreed to participate .
RESULTS	38 patients assigned to robotic therapy and 35 assigned to conventional therapy were included in analyses .
RESULTS	Patients assigned to robotic therapy had significantly greater improvements in motor function in the affected arm over the course of the study as measured by FMA-UE than did those assigned to conventional therapy ( F = 4.1 , p = 0.041 ; mean difference in score 0.78 points , 95 % CI 0.03-1 .53 ) .
RESULTS	No serious adverse events related to the study occurred .
CONCLUSIONS	Neurorehabilitation therapy including task-oriented training with an exoskeleton robot can enhance improvement of motor function in a chronically impaired paretic arm after stroke more effectively than conventional therapy .
CONCLUSIONS	However , the absolute difference between effects of robotic and conventional therapy in our study was small and of weak significance , which leaves the clinical relevance in question .
BACKGROUND	Swiss National Science Foundation and Bangerter-Rhyner Stiftung .

###25647203
OBJECTIVE	Severely injured patients experiencing hemorrhagic shock often require massive transfusion .
OBJECTIVE	Earlier transfusion with higher blood product ratios ( plasma , platelets , and red blood cells ) , defined as damage control resuscitation , has been associated with improved outcomes ; however , there have been no large multicenter clinical trials .
OBJECTIVE	To determine the effectiveness and safety of transfusing patients with severe trauma and major bleeding using plasma , platelets , and red blood cells in a 1:1:1 ratio compared with a 1:1:2 ratio .
METHODS	Pragmatic , phase 3 , multisite , randomized clinical trial of 680 severely injured patients who arrived at 1 of 12 level I trauma centers in North America directly from the scene and were predicted to require massive transfusion between August 2012 and December 2013 .
METHODS	Blood product ratios of 1:1:1 ( 338 patients ) vs 1:1:2 ( 342 patients ) during active resuscitation in addition to all local standard-of-care interventions ( uncontrolled ) .
METHODS	Primary outcomes were 24-hour and 30-day all-cause mortality .
METHODS	Prespecified ancillary outcomes included time to hemostasis , blood product volumes transfused , complications , incidence of surgical procedures , and functional status .
RESULTS	No significant differences were detected in mortality at 24 hours ( 12.7 % in 1:1:1 group vs 17.0 % in 1:1:2 group ; difference , -4.2 % [ 95 % CI , -9.6 % to 1.1 % ] ; P = .12 ) or at 30 days ( 22.4 % vs 26.1 % , respectively ; difference , -3.7 % [ 95 % CI , -10.2 % to 2.7 % ] ; P = .26 ) .
RESULTS	Exsanguination , which was the predominant cause of death within the first 24 hours , was significantly decreased in the 1:1:1 group ( 9.2 % vs 14.6 % in 1:1:2 group ; difference , -5.4 % [ 95 % CI , -10.4 % to -0.5 % ] ; P = .03 ) .
RESULTS	More patients in the 1:1:1 group achieved hemostasis than in the 1:1:2 group ( 86 % vs 78 % , respectively ; P = .006 ) .
RESULTS	Despite the 1:1:1 group receiving more plasma ( median of 7 U vs 5 U , P < .001 ) and platelets ( 12 U vs 6 U , P < .001 ) and similar amounts of red blood cells ( 9 U ) over the first 24 hours , no differences between the 2 groups were found for the 23 prespecified complications , including acute respiratory distress syndrome , multiple organ failure , venous thromboembolism , sepsis , and transfusion-related complications .
CONCLUSIONS	Among patients with severe trauma and major bleeding , early administration of plasma , platelets , and red blood cells in a 1:1:1 ratio compared with a 1:1:2 ratio did not result in significant differences in mortality at 24 hours or at 30 days .
CONCLUSIONS	However , more patients in the 1:1:1 group achieved hemostasis and fewer experienced death due to exsanguination by 24 hours .
CONCLUSIONS	Even though there was an increased use of plasma and platelets transfused in the 1:1:1 group , no other safety differences were identified between the 2 groups .
BACKGROUND	clinicaltrials.gov Identifier : NCT01545232 .

###24423701
OBJECTIVE	To evaluate factors that characterize employees who did not participate in a physical activity intervention in an occupational setting and assess how selective participation affects inferences from the data .
METHODS	Employees were asked to complete a health risk appraisal .
METHODS	The respondents were invited to participate in a physical activity intervention .
METHODS	We compared predictors of sickness absence ( register data ) among all respondents and those who participated in the intervention , using Bayesian regression analysis .
RESULTS	Of 1116 employees , 817 ( 73 % ) responded , of whom 544 ( 67 % ) participated in the intervention .
RESULTS	Participants had better health behaviors and fewer health problems than those who did not participate .
RESULTS	The predictors of sickness absence in all respondents differed from those who participated in the intervention .
CONCLUSIONS	Selective participation may reduce the potential benefit of interventions and limit generalizability of findings .

###25422825
OBJECTIVE	To compare the clinical outcome of 6-mm and 10-mm long implants in partially edentulous posterior areas .
METHODS	Twenty-four patients , with a partially edentulous area in the jaws with a height and width allowing the positioning of 2 to 3 adjacent 10 4.1 mm implants without any augmentation procedure , were randomly allocated according to a parallel group design to receive 6-mm long or 10-mm long implants .
METHODS	A total of 54 implants were placed ( 26 6 mm and 28 10 mm implants ) .
METHODS	Patients were restored 8 weeks after surgery and were followed for 5 years .
METHODS	Outcome measures were prosthesis and implant survival , as well as marginal bone level changes and complications .
RESULTS	After 5 years , 18 patients were available .
RESULTS	One 6 mm implant failed during the healing period and its related prosthesis could not be placed .
RESULTS	No implants were lost after loading .
RESULTS	The 6 mm group registered 5 complications ( 1 mucositis , 3 prosthesis decementations and 1 chipping ) , while only 3 were registered in the 10 mm group ( 2 decementations and 1 chipping ) .
RESULTS	The difference in complications between the two groups was not statistically significant ( P = 0.39 ) .
RESULTS	Marginal bone loss at 5 years was 0.43 and 0.24 mm with the 6 mm and 10 mm groups , respectively ( not statistically significant ; difference between the two groups 0.19 mm ; SD 0.23 mm ; 95 % CI -0.34 ; 0.73 ; t test P = 0.42 ) .
CONCLUSIONS	Implant and prosthetic survival and success rates were similar between prostheses supported by 6-mm or 10-mm long implants .

###25185362
OBJECTIVE	To investigate the effects of Yiqibushenhuoxue decoction on stable chronic obstructive pulmonary disease ( COPD ) by observing its influences on patients ' quality of life and airway inflammation .
METHODS	Seventy patients with stable COPD were randomly divided into a treatment group ( n = 35 ) treated with Yiqibushenhuoxue decoction plus Seretide and a control group ( n = 35 ) treated with Seretide only .
METHODS	The dosage of Yiqibushenhuoxue decoction was 100 mL each time , twice a day , and the dosage of Seretide was salmeterol 50 microg/fluticasone 250 microg twice a day .
METHODS	Both groups were treated for 12 weeks .
METHODS	Before and after the treatment , St George 's respiratory disease questionnaire ( SGRQ ) scores , forced expiratory volume , and forced expiratory volume in 1 second/forced vital capacity ( FEV1 / FVC ) were measured .
RESULTS	The SGRQ scores in both groups were significantly lower than those before treatment ( P < 0.05 ) .
RESULTS	After treatment , the total SGRQ scores and each subscore in the treatment group were significantly lower than those in the control group ( P < 0.05 ) .
RESULTS	The percentage of the predicted FEV1 % and FEV1/FVC were higher in both groups , but no statistical differences were detected from before to after the treatment or between the two groups ( P > 0.05 ) .
CONCLUSIONS	Yiqibushenhuoxue decoction could significantly decrease the SGRQ scores in patients with stable COPD , which suggests that it is able to improve patient symptoms .

###24473376
OBJECTIVE	To explore the effect of clinical pathway of health education in patients with kidney transplantation .
METHODS	A total of 116 patients with kidney transplantation were randomly divided into an experimental group and a control group ( n = 58 in each group ) .
METHODS	The patients in the control group received traditional health education , and the patients in the experimental group experienced the clinical pathway of health education .
METHODS	The effect of health education was assessed and compared .
RESULTS	There was significant difference in the effect of health education between the two groups ( P < 0.05 ) .
CONCLUSIONS	Clinical pathway of health education in patients after kidney transplantation can significantly improve the effect of health education .

###24252803
BACKGROUND	Gait impairment is common in Parkinson 's disease ( PD ) and may result in greater energy expenditure , poorer walking economy , and fatigue during activities of daily living .
BACKGROUND	Auditory cueing is an effective technique to improve gait ; but the effects on energy expenditure are unknown .
OBJECTIVE	To determine whether energy expenditure differs in individuals with PD compared with healthy controls and if auditory cueing improves walking economy in PD .
METHODS	Twenty participants ( 10 PD and 10 controls ) came to the laboratory for three sessions .
METHODS	Participants performed two , 6-minute bouts of treadmill walking at two speeds ( 1.12 msec-1 and 0.67 msec-1 ) .
METHODS	One session used cueing and the other without cueing .
METHODS	A metabolic cart measured energy expenditure and walking economy was calculated ( energy expenditure/power ) .
RESULTS	PD had worse walking economy and higher energy expenditure than control participants during cued and non-cued walking at the 0.67 msec-1 speed and during non-cued walking at the 1.12 msec-1 .
RESULTS	With auditory cueing , energy expenditure and walking economy worsened in both participant groups .
CONCLUSIONS	People with PD use more energy and have worse walking economy than adults without PD .
CONCLUSIONS	Walking economy declines further with auditory cuing in persons with PD .

###25199619
BACKGROUND	Androgen deprivation therapy ( ADT ) is the foundation of treatment for men with metastatic prostate cancer and is now frequently incorporated into multimodality strategies for the curative treatment of locally advanced prostate cancer .
BACKGROUND	Nevertheless , the catabolic effects of ADT result in meaningful adverse effects on physiological and quality of life outcomes , which may , in turn , increase the risk of functional decline , frailty , cardiovascular disease , and metabolic syndrome .
BACKGROUND	Recent evidence demonstrates that lifestyle intervention promoting change in exercise and dietary behaviors is a promising approach , and may offset , or even reverse , the adverse effects accompanying ADT .
BACKGROUND	Unfortunately , the limited existing studies of the effects of exercise and dietary interventions targeting patients with prostate cancer on ADT are characterized by high attrition rates and poor postintervention maintenance of treatment effects .
BACKGROUND	Consequently , the Individualized Diet and Exercise Adherence Pilot Trial ( IDEA-P ) is designed to contrast the effects of a lifestyle intervention designed to promote independent self-management of exercise and dietary behavior with those of standard care disease management approach in the treatment of prostate cancer .
METHODS	A total of 40 patients with prostate cancer undergoing ADT will be randomly assigned to lifestyle intervention or standard care .
METHODS	Outcomes of interest in IDEA-P include changes in self-reported and objectively assessed physical function and physical activity , dietary behavior , body composition , muscular strength , and quality of life .
METHODS	Outcomes will be obtained at baseline , 2-month , and 3-month assessments by trial personnel blinded to participants ' randomization assignment .
CONCLUSIONS	Findings from this study will establish the feasibility and preliminary efficacy of an innovative lifestyle intervention designed to promote progressively independent self-regulated exercise and dietary behavior change in the treatment of patients with prostate cancer undergoing ADT .
BACKGROUND	ClinicalTrials.gov NCT02050906 .

###24948511
BACKGROUND	Metformin is the recommended first-line pharmacotherapy for patients with type 2 diabetes .
BACKGROUND	There is no consensus on the optimum second-line pharmacotherapy .
BACKGROUND	We compared the efficacy and safety of the sodium glucose cotransporter 2 inhibitor empagliflozin and the sulfonylurea glimepiride as add-on to metformin in patients with type 2 diabetes .
METHODS	In this double-blind phase 3 trial , patients ( aged 18 years ) with type 2 diabetes and HbA1c concentrations of 7-10 % , despite metformin treatment and diet and exercise counselling , were randomly assigned in a 1:1 ratio with a computer-generated random sequence , stratified by HbA1c , estimated glomerular filtration rate ( eGFR ) , and region , to empagliflozin ( 25 mg once daily , orally ) or glimepiride ( 1-4 mg once daily , orally ) as add-on to metformin for 104 weeks .
METHODS	Patients and investigators were masked to treatment assignment .
METHODS	The primary endpoint was change from baseline in HbA1c levels at weeks 52 and 104 .
METHODS	Differences in the primary endpoint were first tested for non-inferiority ( based on a margin of 03 % ) .
METHODS	If non-inferiority was shown , differences in the primary endpoint at week 104 were then tested for superiority .
METHODS	Analysis was done on the full-analysis set-ie , patients who were treated with at least one dose of study drug and had a baseline HbA1c value .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01167881 .
METHODS	A 104-week extension is ongoing .
RESULTS	Between August , 2010 , and June , 2011 , 1549 patients were randomly assigned to receive empagliflozin ( n = 769 ) or glimepiride ( n = 780 ) ; four patients in the empagliflozin group did not receive the assigned treatment .
RESULTS	Empagliflozin was non-inferior to glimepiride at both timepoints .
RESULTS	At week 104 , adjusted mean difference in change from baseline in HbA1c with empagliflozin versus glimepiride was -011 % ( 95 % CI -019 to -002 ; p = 00153 for superiority ) .
RESULTS	Adverse events were reported in 661 ( 86 % ) patients treated with empagliflozin and 673 ( 86 % ) patients treated with glimepiride .
RESULTS	Severe adverse events were reported in 72 ( 9 % ) patients in the empagliflozin group and 68 ( 9 % ) in the glimepiride group .
RESULTS	Serious adverse events were reported in 119 ( 16 % ) patients in the empagliflozin group and 89 ( 11 % ) in the glimepiride group .
RESULTS	Confirmed hypoglycaemic adverse events ( plasma glucose 39 mmol/L or requiring assistance ) at week 104 were reported in 19 ( 2 % ) patients treated with empagliflozin and 189 ( 24 % ) patients treated with glimepiride .
CONCLUSIONS	Empagliflozin might be an effective and a well tolerated second-line treatment option for patients with type 2 diabetes who have not achieved good glycaemic control on metformin .
BACKGROUND	Boehringer Ingelheim and Eli Lilly .

###24708775
BACKGROUND	Postprandial elevation of triglyceride-rich lipoproteins impairs endothelial function , which can initiate atherosclerosis .
BACKGROUND	We investigated the effects of bezafibrate on postprandial endothelial dysfunction and lipid profiles in patients with metabolic syndrome .
METHODS	Ten patients with metabolic syndrome were treated with 400 mg/day bezafibrate or untreated for 4 weeks in a randomized crossover study .
METHODS	Brachial artery flow-mediated dilation ( FMD ) and lipid profiles were assessed during fasting and after consumption of a standardized snack .
METHODS	Serum triglyceride and cholesterol contents of lipoprotein fractions were analyzed by high-performance liquid chromatography .
RESULTS	Postprandial FMD decreased significantly and reached its lowest value 4 h after the cookie test in both the bezafibrate and control groups , but the relative change in FMD from baseline to minimum in the bezafibrate group was significantly smaller than that in the control group ( -29.05.9 vs. -42.96.2 % , p = 0.04 ) .
RESULTS	Bezafibrate significantly suppressed postprandial elevation of triglyceride ( incremental area under the curve ( AUC ) : 54465 vs. 1158283 mg h/dl , p = 0.02 ) and remnant lipoprotein cholesterol ( incremental AUC : 27.93.5 vs. 72.314.1 mg h/dl , p < 0.01 ) .
RESULTS	High-performance liquid chromatography analysis revealed that postprandial triglyceride content of the chylomicron and very low-density lipoprotein fractions was significantly lower in the bezafibrate group than in the control group ( p < 0.05 ) .
CONCLUSIONS	Bezafibrate significantly decreased postprandial endothelial dysfunction , and elevations of both exogenous and endogenous triglycerides in patients with metabolic syndrome , suggesting that bezafibrate may have vascular protective effects in these patients .
BACKGROUND	Unique Identifiers : UMIN000012557 .

###24252943
OBJECTIVE	To compare the therapeutic efficacy of recombinant human brain natriuretic peptide and prostaglandin E1 in the treatment of pulmonary hypertension after mitral valve replacement .
METHODS	Sixty patients with postoperative pulmonary hypertension were divided randomly into 3 groups that received saline , prostaglandin E1 , and natriuretic peptide infusions for 12 hours each .
METHODS	The hemodynamics data were monitored consecutively , and the levels of thromboxane A2 and cyclic guanosine monophosphate were detected pretreatment , after treatment , and 1 week after surgery .
RESULTS	The arterial pressure , pulmonary arterial pressure , and pulmonary capillary wedge pressure decreased 1hour after prostaglandin E1 treatment and rebounded after treatment discontinuation .
RESULTS	The pulmonary arterial pressure and pulmonary capillary wedge pressure in the natriuretic peptide group decreased 3 hours after treatment ; pulmonary arterial pressure decreased less than that of the prostaglandin group , and there was no evidence of hemodynamic rebound after treatment discontinuation .
RESULTS	The natriuretic peptide had no significant effects on arterial pressure .
RESULTS	In both the prostaglandin and natriuretic peptide groups , cyclic guanosine monophosphate increased after the treatment , which was even higher in the latter group .
RESULTS	Prostaglandin E1 could lead to the decrease of thromboxane A2 , which was not seen in the natriuretic peptide group .
CONCLUSIONS	Both brain natriuretic peptide and prostaglandin E1 can effectively reduce pulmonary hypertension ; however , natriuretic peptide has a slower and milder efficacy .
CONCLUSIONS	The effects of these 2 drugs in reducing thepulmonary arterial pressure may be mediated through different pathways .

###25141114
OBJECTIVE	Anemia is a common complication among chronic kidney disease patients on hemodialysis , occurring mostly due to erythropoietin deficiency .
OBJECTIVE	This randomized noninferiority trial sought to compare the efficacy and safety of a new epoetin formulation developed by Bio-Manguinhos , a biologics manufacturer affiliated with the Brazilian government , with those of a commercially available product currently used in Brazil ( a biosimilar epoetin formulation ) .
METHODS	The sample size needed to enable demonstration of noninferiority with a statistical power of 85 % for a between-group difference in hemoglobin levels of no more than 1.5 g/dL was calculated .
METHODS	In total , 74 patients were randomly assigned to receive the epoetin formulation from Bio-Manguinhos ( n = 36 ) or the biosimilar epoetin formulation ( n = 38 ) in a double-blind fashion .
METHODS	The inclusion criteria were current epoetin therapy and stable hemoglobin levels for at least 3 months prior to the study .
METHODS	The primary and secondary outcomes were mean monthly hemoglobin levels and safety , respectively .
METHODS	The dose was calculated according to international criteria and adjusted monthly in both groups according to hemoglobin levels and at the assistant physicians ' discretion .
METHODS	Iron storage was estimated at baseline and once monthly .
METHODS	Clinicaltrials.gov : NCT01184495 .
RESULTS	The study was conducted for 6 months after randomization .
RESULTS	The mean baseline hemoglobin levels were 10.91.2 and 10.961.2 g/dL ( p = 0.89 ) in the Bio-Manguinhos epoetin and biosimilar epoetin groups , respectively .
RESULTS	During the study period , there was no significant change in hemoglobin levels in either group ( p = 0.055 , ANOVA ) .
RESULTS	The epoetin from Bio-Manguinhos was slightly superior in the last 3 months of follow-up .
RESULTS	The adverse event profiles of the two formulations were also similar .
CONCLUSIONS	The epoetin formulations tested in this study are equivalent in efficacy and safety .

###25046070
OBJECTIVE	This study aims to compare the effectiveness of desloratadine monotherapy and desloratadine plus montelukast combination therapy on quality of life in patients with persistent allergic rhinitis .
METHODS	This study consists of 40 patients ( 28 females , 12 males , mean age 29.8 years ; range 17 to 44 years ) referred to ear , nose , and throat outpatient clinic between May 2010 and September 2010 .
METHODS	A six-week randomized , double-blind , cross-sectional study was performed in two arms : In group 1 , 20 patients received desloratadine ( 5 mg/d ) alone ; in group 2 , 20 patients received desloratadine ( 5 mg ) plus montelukast ( 10 mg ) combination therapy .
METHODS	Quality of life was assessed on the day before starting treatment and on the last day of each treatment period using the Rhinoconjunctivitis Quality of Life Questionnaire and Nighttime Symptom Scores .
RESULTS	In group 1 , the mean quality of life scores before and after treatment were 3.17 and 2.43 , respectively .
RESULTS	In group 2 , the mean quality of life scores before and after treatment were 2.94 and 1.73 , respectively .
CONCLUSIONS	Desloratadine plus montelukast combination therapy may have a positive impact on quality of life , sleep symptoms in particular .

###24322572
BACKGROUND	Our hypothesis was that deep anaesthesia , as estimated by a low target bispectral index ( BIS ) of 30-40 , would result in less postoperative pain than that achieved at a conventional depth of anaesthesia .
METHODS	We undertook a randomized double-blind controlled study at two tertiary teaching hospitals in New Zealand ( 2010-1 ) recruiting 135 adult patients ASA I-II presenting for non-emergent surgery under general anaesthesia requiring tracheal intubation .
METHODS	Anaesthesia was maintained with desflurane and a multimodal analgesia regimen comprising fentanyl infusion , i.v. paracetamol , and parecoxib .
METHODS	Patients were randomly assigned to either a low BIS ( 30-40 ) group or a high BIS ( 45-60 ) group .
METHODS	Desflurane concentrations were titrated to achieve these targets .
METHODS	Postoperative pain was assessed by : the pain on awakening ( 0-10 , verbal rating scale , VRS ( awake ) ) in the post-anaesthetic care unit ; pain on activity at 20-24 h after operation ( VRS ( d1A ) ) ; and the rate of morphine patient-controlled analgesia ( PCA ) usage over the first 24 h.
RESULTS	There was no statistically significant difference between the two groups for any of the pain scores .
RESULTS	The median [ inter-quartile range ( IQR ) ] VRS ( awake ) was 4.0 ( 0-8 ) for the low and 4.0 ( 0-8 ) for the high BIS groups ( P = 0.56 ) .
RESULTS	The median ( IQR ) VRS ( d1A ) was 3.0 ( 1-5 ) for the low and 3.0 ( 1.5-4 .5 ) for the high BIS groups ( P = 0.83 ) .
RESULTS	The median PCA morphine consumption in the low BIS group was 0.61 mg h ( -1 ) ( 0.04-1 .5 ) vs 0.43 mg h ( -1 ) ( 0-1 .59 ) in the high BIS group ( P = 0.98 ) .
CONCLUSIONS	We conclude that there is no clinically useful analgesic effect of a deep anaesthesia regimen .

###24725468
BACKGROUND	Poor adherence to treatment diminishes its individual and public health benefit .
BACKGROUND	Financial incentives , provided on the condition of treatment attendance , could address this problem .
BACKGROUND	Injecting drug users are a high-risk group for hepatitis B virus ( HBV ) infection and transmission , but adherence to vaccination programmes is poor .
BACKGROUND	We aimed to assess whether contingency management delivered in routine clinical practice increased the completion of HBV vaccination in individuals receiving opioid substitution therapy .
METHODS	In our cluster randomised controlled trial , we enrolled participants at 12 National Health Service drug treatment services in the UK that provided opioid substitution therapy and nurse-led HBV vaccination with a super-accelerated schedule ( vaccination days 0 , 7 , and 21 ) .
METHODS	Clusters were randomly allocated 1:1:1 to provide vaccination without incentive ( treatment as usual ) , with fixed value contingency management ( three 10 vouchers ) , or escalating value contingency management ( 5 , 10 , and 15 vouchers ) .
METHODS	Both contingency management schedules rewarded on-time attendance at appointments .
METHODS	The primary outcome was completion of clinically appropriate HBV vaccination within 28 days .
METHODS	We also did sensitivity analyses that examined vaccination completion with full adherence to appointment times and within a 3 month window .
METHODS	The trial is registered with Current Controlled Trials , number ISRCTN72794493 .
RESULTS	Between March 16 , 2011 , and April 26 , 2012 , we enrolled 210 eligible participants .
RESULTS	Compared with six ( 9 % ) of 67 participants treated as usual , 35 ( 45 % ) of 78 participants in the fixed value contingency management group met the primary outcome measure ( odds ratio 121 , 95 % CI 37-399 ; p < 00001 ) , as did 32 ( 49 % ) of 65 participants in the escalating value contingency management group ( 140 , 42-462 ; p < 00001 ) .
RESULTS	These differences remained significant with sensitivity analyses .
CONCLUSIONS	Modest financial incentives delivered in routine clinical practice significantly improve adherence to , and completion of , HBV vaccination programmes in patients receiving opioid substitution therapy .
CONCLUSIONS	Achievement of this improvement in routine clinical practice should now prompt actual implementation .
CONCLUSIONS	Drug treatment providers should employ contingency management to promote adherence to vaccination programmes .
CONCLUSIONS	The effectiveness of routine use of contingency management to achieve long-term behaviour change remains unknown .
BACKGROUND	National Institute for Health Research ( RP-PG-0707-10149 ) .

###24712335
OBJECTIVE	To evaluate the effectiveness of a telephonic medication therapy management ( MTM ) service on reducing hospitalizations among home health patients .
METHODS	Forty randomly selected , geographically diverse home health care centers in the United States .
METHODS	Two-stage , randomized , controlled trial with 60-day follow-up .
METHODS	All Medicare - insured home health care patients were eligible to participate .
METHODS	Twenty-eight consecutive patients within each care center were recruited and randomized to usual care or MTM intervention .
METHODS	The MTM intervention consisted of the following : ( 1 ) initial phone call by a pharmacy technician to verify active medications ; ( 2 ) pharmacist-provided medication regimen review by telephone ; and ( 3 ) follow-up pharmacist phone calls at day seven and as needed for 30 days .
METHODS	The primary outcome was 60-day all-cause hospitalization .
METHODS	Data were collected from in-home nursing assessments using the OASIS-C .
METHODS	Multivariate logistic regression modeled the effect of the MTM intervention on the probability of hospitalization while adjusting for patients ' baseline risk of hospitalization , number of medications taken daily , and other OASIS-C data elements .
RESULTS	A total of 895 patients ( intervention n = 415 , control n = 480 ) were block-randomized to the intervention or usual care .
RESULTS	There was no significant difference in the 60-day probability of hospitalization between the MTM intervention and control groups ( Adjusted OR : 1.26 , 95 percent CI : 0.89-1 .77 , p = .19 ) .
RESULTS	For patients within the lowest baseline risk quartile ( n = 232 ) , the intervention group was three times more likely to remain out of the hospital at 60 days ( Adjusted OR : 3.79 , 95 percent CI : 1.35-10 .57 , p = .01 ) compared to the usual care group .
CONCLUSIONS	This MTM intervention may not be effective for all home health patients ; however , for those patients with the lowest-risk profile , the MTM intervention prevented patients from being hospitalized at 60 days .

###25064594
BACKGROUND	Regular paracetamol is the recommended first-line analgesic for acute low-back pain ; however , no high-quality evidence supports this recommendation .
BACKGROUND	We aimed to assess the efficacy of paracetamol taken regularly or as-needed to improve time to recovery from pain , compared with placebo , in patients with low-back pain .
METHODS	We did a multicentre , double-dummy , randomised , placebo controlled trial across 235 primary care centres in Sydney , Australia , from Nov 11 , 2009 , to March 5 , 2013 .
METHODS	We randomly allocated patients with acute low-back pain in a 1:1:1 ratio to receive up to 4 weeks of regular doses of paracetamol ( three times per day ; equivalent to 3990 mg paracetamol per day ) , as-needed doses of paracetamol ( taken when needed for pain relief ; maximum 4000 mg paracetamol per day ) , or placebo .
METHODS	Randomisation was done according to a centralised randomisation schedule prepared by a researcher who was not involved in patient recruitment or data collection .
METHODS	Patients and staff at all sites were masked to treatment allocation .
METHODS	All participants received best-evidence advice and were followed up for 3 months .
METHODS	The primary outcome was time until recovery from low-back pain , with recovery defined as a pain score of 0 or 1 ( on a 0-10 pain scale ) sustained for 7 consecutive days .
METHODS	All data were analysed by intention to treat .
METHODS	This study is registered with the Australian and New Zealand Clinical Trial Registry , number ACTN 12609000966291 .
RESULTS	550 participants were assigned to the regular group ( 550 analysed ) , 549 were assigned to the as-needed group ( 546 analysed ) , and 553 were assigned to the placebo group ( 547 analysed ) .
RESULTS	Median time to recovery was 17 days ( 95 % CI 14-19 ) in the regular group , 17 days ( 15-20 ) in the as-needed group , and 16 days ( 14-20 ) in the placebo group ( regular vs placebo hazard ratio 099 , 95 % CI 087-114 ; as-needed vs placebo 105 , 092-119 ; regular vs as-needed 105 , 092-120 ) .
RESULTS	We recorded no difference between treatment groups for time to recovery ( adjusted p = 079 ) .
RESULTS	Adherence to regular tablets ( median tablets consumed per participant per day of maximum 6 ; 40 [ IQR 16-57 ] in the regular group , 39 [ 15-56 ] in the as-needed group , and 40 [ 15-57 ] in the placebo group ) , and number of participants reporting adverse events ( 99 [ 185 % ] in the regular group , 99 [ 187 % ] in the as-needed group , and 98 [ 185 % ] in the placebo group ) were similar between groups .
CONCLUSIONS	Our findings suggest that regular or as-needed dosing with paracetamol does not affect recovery time compared with placebo in low-back pain , and question the universal endorsement of paracetamol in this patient group .
BACKGROUND	National Health and Medical Research Council of Australia and GlaxoSmithKline Australia .

###24881806
BACKGROUND	The aim of the present study was to investigate whether addition of transcutaneous electrical nerve stimulation ( TENS ) treatment improves the results of standard urotherapy in children with overactive bladder ( OAB ) symptoms .
METHODS	Sixty-two children with symptoms of OAB and incontinence were included .
METHODS	The children were randomized either to standard urotherapy treatment alone or a combination of standard urotherapy and TENS .
METHODS	The effect variables were taken from a voiding-drinking diary : number of voiding , number of incontinence episodes , and maximum voided volume .
RESULTS	Both treatment groups had good treatment results , with no significant difference between the groups .
RESULTS	In the standard treatment group 13/28 ( 46 % ) were completely dry and 11/28 ( 40 % ) had a decrease in incontinence episodes , compared to 16/24 ( 67 % ) and 3/24 ( 13 % ) , respectively , in the standard + TENS group ( p = 0.303 ) .
RESULTS	The number of voiding decreased in two-thirds of the patients in both groups .
RESULTS	However , maximal voided volume only increased in the standard treatment group .
RESULTS	Subjectively 72 % and 80 % considered themselves significantly improved or free of symptoms .
RESULTS	Previous treatment was registered in 15/55 ( 27 % ) .
RESULTS	All efficacy variables decreased in those with previous treatment , but with no difference between the standard and standard + TENS treatment groups .
RESULTS	The only difference noted was when comparing the children without previous treatment in the groups : a significantly higher proportion were completely dry in the TENS group ( 12/18 [ 71 % ] versus 10/22 [ 48 % ] , p = 0.05 ) .
CONCLUSIONS	Our results showed no significant difference overall in treatment response to OAB symptoms between urotherapy only and urotherapy + TENS , whereas a tendency to difference was found in children without previous treatment .
CONCLUSIONS	Thus with good urotherapy support , TENS only seems to have marginal additional effects on OAB symptoms .

###25292092
BACKGROUND	Pancreatic cancer is the sixth leading cause of cancer death with an increasing trend in China .
BACKGROUND	Dietary intake is believed to play an important role in pancreatic cancer carcinogenesis .
BACKGROUND	The aim of this paper was to evaluate associations between some dietary factors and risk of pancreatic cancer in a multi-centre case-control study conducted in China .
METHODS	Cases ( n = 323 ) were ascertained from four provincial cancer hospitals .
METHODS	Controls ( n = 323 ) were randomly selected from the family members of patients without pancreatic cancer in the same hospitals , 1:1 matched to cases by gender , age and study center .
METHODS	Data were collected with a questionnaire by personal interview .
METHODS	Odds ratios ( OR ) and 95 % confidence intervals ( 95 % CI ) were estimated using conditional logistic regression .
RESULTS	Tea intake ( OR = 0.49 ; 95 % CI : 0.30-0 .80 ) was associated with a half reduction in risk of pancreatic cancer .
RESULTS	Reduced vegetable consumption ( P trend : 0.04 ) was significant related to pancreatic cancer .
RESULTS	Although no significant association was found for meat and fruit , ORs were all above or below the reference group .
RESULTS	A protective effect was found for fruit ( OR = 1.73 for consumption of 1-2 times/week vs more than 3 times/week ; 95 % CI : 1.05-2 .86 ) .
RESULTS	A high intake of meat was associated to a higher risk of pancreatic cancer ( OR = 0.59 for consumption of 1-2 times / week vs. more than 3 times / week ; 95 % CI : 0.35-0 .97 ) .
CONCLUSIONS	The present study supports fruit consumption to reduce pancreatic cancer risk and indicates that high consumption of meat is related to an elevated risk .
CONCLUSIONS	Direct inverse relations with tea and vegetable intake were also confirmed .

###24425697
BACKGROUND	Rapid treatment of acute coronary syndromes ( ACS ) is important ; causes of delay in emergency medical services care of ACS are poorly understood .
RESULTS	We performed an analysis of data from IMMEDIATE ( Immediate Myocardial Metabolic Enhancement during Initial Assessment and Treatment in Emergency Care ) , a randomized controlled trial of emergency medical services treatment of people with symptoms suggesting ACS , using hierarchical multiple regression of elapsed time .
RESULTS	Out-of-hospital ECGs were performed on 54,230 adults calling 9-1-1 ; 871 had presumed ACS , 303 of whom had ST-segment elevation myocardial infarction and underwent percutaneous coronary intervention .
RESULTS	Women , participants with diabetes mellitus , and participants without previous cardiovascular disease waited longer to call 9-1-1 ( by 28 minutes , P < 0.01 ; 10 minutes , P = 0.03 ; and 6 minutes , P = 0.02 , respectively ) , compared with their counterparts .
RESULTS	Time from emergency medical services arrival to ECG was longer for women ( 1.5 minutes ; P < 0.01 ) , older individuals ( 1.3 minutes ; P < 0.01 ) , and those without a primary complaint of chest pain ( 3.5 minutes ; P < 0.01 ) .
RESULTS	On-scene times were longer for women ( 2 minutes ; P < 0.01 ) and older individuals ( 2 minutes ; P < 0.01 ) .
RESULTS	Older individuals and participants presenting on weekends and nights had longer door-to-balloon times ( by 10 , 14 , and 11 minutes , respectively ; P < 0.01 ) .
RESULTS	Women and older individuals had longer total times ( medical contact to balloon inflation : 16 minutes , P = 0.01 , and 9 minutes , P < 0.01 , respectively ; symptom onset to balloon inflation : 31.5 minutes for women ; P = 0.02 ) .
CONCLUSIONS	We found delays throughout ACS care , resulting in substantial differences in total times for women and older individuals .
CONCLUSIONS	These delays may impact outcomes ; a comprehensive approach to reduce delay is needed .

###25095322
OBJECTIVE	To evaluate and compare the efficacy and safety of Intranasal ( IN ) Dexmedetomidine , Midazolam and Ketamine in producing moderate sedation among uncooperative pediatric dental patients .
METHODS	This randomized triple blind comparative study comprises of eighty four ASA grade I children of both sexes aged 4-14 years , who were uncooperative and could not be managed by conventional behavior management techniques .
METHODS	All the children were randomized to receive one of the four drug groups Dexmedetomidine 1 microg / kg ( D1 ) , 1.5 microg/kg ( D2 ) , Midazolam 0.2 mg/kg ( M1 ) and Ketamine 5 mg/kg ( K1 ) through IN route .
METHODS	These drug groups were assessed for efficacy and safety by gauging overall success rate and by monitoring vital signs , respectively .
RESULTS	The onset of sedation was significantly rapid with M1 and K1 as compared to D1 and D2 ( p = < 0.001 ) .
RESULTS	The overall success rate was highest in D2 ( 85.7 % ) followed by D1 ( 81 % ) , K1 ( 66.7 % ) and M1 ( 61.9 % ) , however , the difference among them was not statistically significant ( p = > 0.05 ) .
RESULTS	Even though all the vital signs were within physiological limits , there was significant reduction in pulse rate ( PR ) ( p = < 0.001 ) and systolic blood pressure ( SBP ) ( p = < 0.05 ) among D1 and D2 as compared to M1 and K1 .
RESULTS	D1 , D2 and K1 produced greater intra - and post-operative analgesia as compared to M1 .
RESULTS	There were no significant adverse effects with any group .
CONCLUSIONS	Dexmedetomidine , Midazolam and Ketamine , all the three drugs evaluated in the present study can be used safely and effectively through IN route in uncooperative pediatric dental patients for producing moderate sedation .

###24430917
OBJECTIVE	There are no medications approved for treating cannabis dependence or withdrawal .
OBJECTIVE	The cannabis extract nabiximols ( Sativex ) , developed as a multiple sclerosis treatment , offers a potential agonist medication for cannabis withdrawal .
OBJECTIVE	To evaluate the safety and efficacy of nabiximols in treating cannabis withdrawal .
METHODS	A 2-site , double-blind randomized clinical inpatient trial with a 28-day follow-up was conducted in New South Wales , Australia .
METHODS	Participants included 51 DSM-IV-TR cannabis-dependent treatment seekers .
METHODS	A 6-day regimen of nabiximols ( maximum daily dose , 86.4 mg of 9-tetrahydrocannabinol and 80 mg of cannabidiol ) or placebo with standardized psychosocial interventions during a 9-day admission .
METHODS	Severity of cannabis withdrawal and cravings ( Cannabis Withdrawal Scale ) , retention in withdrawal treatment , and adverse events .
METHODS	Secondary outcomes include postwithdrawal cannabis use , health outcomes , and psychosocial outcomes .
RESULTS	Nabiximols treatment significantly reduced the overall severity of cannabis withdrawal relative to placebo ( F8 ,377.97 = 2.39 ; P = .01 ) , including effects on withdrawal-related irritability , depression , and cannabis cravings .
RESULTS	Nabiximols had a more limited , but still positive , therapeutic benefit on sleep disturbance , anxiety , appetite loss , physical symptoms , and restlessness .
RESULTS	Nabiximols patients remained in treatment longer during medication use ( unadjusted hazard ratio , 3.66 [ 95 % CI , 1.18-11 .37 ] ; P = .02 ) , with 2.84 the number needed to treat to achieve successful retention in treatment .
RESULTS	Participants could not reliably differentiate between nabiximols and placebo treatment ( 21 = 0.79 ; P = .67 ) , and those receiving nabiximols did not report greater intoxication ( F1 ,6 = 0.22 ; P = .97 ) .
RESULTS	The number ( F1 ,50 = 0.3 ; P = .59 ) and severity ( F1 ,50 = 2.69 ; P = .10 ) of adverse events did not differ significantly between groups .
RESULTS	Both groups showed reduced cannabis use at follow-up , with no advantage of nabiximols over placebo for self-reported cannabis use ( F1 ,48 = 0.29 ; P = .75 ) , cannabis-related problems ( F1 ,49 = 2.33 ; P = .14 ) , or cannabis dependence ( F1 ,50 < 0.01 ; P = .89 ) .
CONCLUSIONS	In a treatment-seeking cohort , nabiximols attenuated cannabis withdrawal symptoms and improved patient retention in treatment .
CONCLUSIONS	However , placebo was as effective as nabiximols in promoting long-term reductions in cannabis use following medication cessation .
CONCLUSIONS	The data support further evaluation of nabiximols for management of cannabis dependence and withdrawal in treatment-seeking populations .
BACKGROUND	anzctr.org.au Identifier : ACTRN12611000398909 .

###25110677
BACKGROUND	According to the present evidences suggesting association between low testosterone level and prediction of reduced exercise capacity as well as poor clinical outcome in patients with heart failure , we sought to determine if testosterone therapy improves clinical and cardiovascular conditions as well as quality of life status in patients with stable chronic heart failure .
METHODS	A total of 50 male patients who suffered from congestive heart failure were recruited in a double-blind , placebo-controlled trial and randomized to receive an intramuscular ( gluteal ) long-acting androgen injection ( 1mL of testosterone enanthate 250mg/mL ) once every four weeks for 12 weeks or receive intramuscular injections of saline ( 1mL of 0.9 % wt/vol NaCl ) with the same protocol .
RESULTS	The changes in body weight , hemodynamic parameters , and left ventricular dimensional echocardiographic indices were all comparable between the two groups .
RESULTS	Regarding changes in diastolic functional state and using Tei index , this parameter was significantly improved .
RESULTS	Unlike the group received placebo , those who received testosterone had a significant increasing trend in 6-walk mean distance ( 6MWD ) parameter within the study period ( P = 0.019 ) .
RESULTS	The discrepancy in the trends of changes in 6MWD between study groups remained significant after adjusting baseline variables ( mean square = 243.262 , F index = 4.402 , and P = 0.045 ) .
CONCLUSIONS	Our study strengthens insights into the beneficial role of testosterone in improvement of functional capacity and quality of life in heart failure patients .

###25209550
BACKGROUND	Cytopenias are the most common HIV-associated hematological abnormality .
BACKGROUND	Cytopenias have been associated with several factors including sex , race/ethnicity , geographical location and comorbidities such as tuberculosis , hepatitis B infection , fever and oral candidiasis .
BACKGROUND	Cytopenias become more prevalent as HIV progresses and are often fatal .
BACKGROUND	Data from resource-limited settings about the prevalence and correlates of cytopenia are limited .
BACKGROUND	Therefore we conducted this cross-sectional study to assess the prevalence and correlates of cytopenia among adult AIDS patients at initiation of HAART in Uganda .
METHODS	400 HIV-infected subjects who were HAART-nave or on HAART for6months were enrolled into the Multivitamins , HAART and HIV/AIDS Trial .
METHODS	Anemia was defined according to WHO guidelines as any hemoglobin concentration < 12g/dl for non-pregnant females and < 13g/dl for males .
METHODS	Leucopenia and thrombocytopenia were defined using study site laboratory reference ranges for lack of generally accepted definitions for these 2 cell lines as leucopenia if white blood cell count < 2.75109 cells/litre and thrombocytopenia if platelets < 125109 cells/litre for females and < 156109 cells/litre for males .
METHODS	Univariate and bivariate analyses were done to describe the patient population and log-binomial regression was used to quantify the correlates of cytopenia .
RESULTS	Sixty five percent of the 400 subjects had at least one form of cytopenia .
RESULTS	Anemia occurred in 47.8 % , leucopenia in 24.3 % , thrombocytopenia in 8.3 % , bicytopenia in 21.9 % and only 2 had a pancytopenia .
RESULTS	Cytopenia was more prevalent in females ( prevalence ratio [ PR ] :1.33 , 95 % confidence interval [ CI ] :1.12 -1.59 ) ; CD4 count category 50 to < 200 ( PR : 0.75 , 95 % CI : 0.64 -0.88 ) and CD4 count category 200 to < 350 ( PR : 0.74 , 95 % CI : 0.59 - 0.92 ) compared to CD4 count category < 50 ; normal BMI ( PR : 0.82 , 95 % CI :0.68 -1.00 ) and overweight BMI ( PR : 0.64 , 95 % CI :0.50 - 0.82 ) compared to underweight BMI and those with a history or presence of oral candidiasis .
CONCLUSIONS	Cytopenias are a frequent complication in HIV-infected adults at initiation of HAART in Uganda .
CONCLUSIONS	The presence of any cytopenia was associated with female sex , decreasing CD4 count and decreasing body mass index .
CONCLUSIONS	Prospective studies in resource-limited settings on the trend in HIV-related cytopenias are needed .

###24568227
BACKGROUND	Although balance is generally recognized to be an important feature in ensuring good performance in soccer , its link with functional performance remains mostly unexplored , especially in young athletes .
OBJECTIVE	To investigate changes in balance induced by fatigue for unipedal and bipedal static stances in young soccer players .
METHODS	Crossover study .
METHODS	Biomechanics laboratory and outdoor soccer field .
METHODS	Twenty-one male soccer players ( age = 14.5 0.2 years , height = 164.5 5.6 cm , mass = 56.8 6.8 kg ) .
METHODS	Static balance was assessed with postural-sway analysis in unipedal and bipedal upright stance before and after a fatigue protocol consisting of a repeated sprint ability ( RSA ) test ( 2 15-m shuttle sprint interspersed with 20 seconds of passive recovery , repeated 6 times ) .
METHODS	On the basis of the center-of-pressure ( COP ) time series acquired during the experimental tests , we measured sway area , COP path length , and COP maximum displacement and velocity in the anteroposterior and mediolateral directions .
RESULTS	Fatigue increased all sway values in bipedal stance and all values except COP velocity in the mediolateral direction in unipedal stance .
RESULTS	Fatigue index ( calculated on the basis of RSA performance ) was positively correlated with fatigue/rest sway ratio for COP path length and COP velocity in the anteroposterior and mediolateral directions for nondominant single-legged stance .
CONCLUSIONS	Fatigued players exhibited reduced performance of the postural-control system .
CONCLUSIONS	Participants with better performance in the RSA test appeared less affected by balance impairment , especially in single-legged stance .

###25837277
BACKGROUND	We performed a proof of concept trial to evaluate relative safety and efficacy of Rhodiola rosea ( R. rosea ) versus sertraline for mild to moderate major depressive disorder .
OBJECTIVE	We hypothesize that R. rosea would have similar therapeutic effects as sertraline but with less adverse events .
METHODS	Phase II randomized placebo controlled clinical trial .
METHODS	57 subjects were randomized to 12 weeks of standardized R. rosea extract , sertraline , or placebo .
METHODS	Changes over time in Hamilton Depression Rating ( HAM-D ) , Beck Depression Inventory ( BDI ) , and Clinical Global Impression Change ( CGI/C ) scores among groups were examined using mixed-effects models .
RESULTS	Modest , albeit statistically non-significant , reductions were observed for HAM-D , BDI , and CGI/C scores for all treatment conditions with no significant difference between groups ( p = 0.79 , p = 0.28 , and p = 0.17 , respectively ) .
RESULTS	The decline in HAM-D scores was greater for sertraline ( -8.2 , 95 % confidence interval [ CI ] , -12.7 to -3.6 ) versus R. rosea ( -5.1 , 95 % CI : -8.8 to -1.3 ) and placebo ( -4.6 , 95 % CI : -8.6 to -0.6 ) .
RESULTS	While the odds of improving ( versus placebo ) were greater for sertraline ( 1.90 [ 0.44-8 .20 ] ; odds ratio [ 95 % CI ] ) than R. rosea ( 1.39 [ 0.38-5 .04 ] ) , more subjects on sertraline reported adverse events ( 63.2 % ) than R. rosea ( 30.0 % ) or placebo ( 16.7 % ) ( p = 0.012 ) .
CONCLUSIONS	Although R. rosea produced less antidepressant effect versus sertraline , it also resulted in significantly fewer adverse events and was better tolerated .
CONCLUSIONS	These findings suggest that R. rosea , although less effective than sertraline , may possess a more favorable risk to benefit ratio for individuals with mild to moderate depression .

###24591821
BACKGROUND	Falls are common among older adults .
BACKGROUND	It is reported that approximately 60 % of residents of aged care facilities fall each year .
BACKGROUND	This is a major cause of morbidity and mortality , and a significant burden for health care providers and the health system .
BACKGROUND	Among community dwelling older adults , exercise appears to be an effective countermeasure , but data are limited and inconsistent among studies in residents of aged care communities .
BACKGROUND	This trial has been designed to evaluate whether the SUNBEAM program ( Strength and Balance Exercise in Aged Care ) reduces falls in residents of aged care facilities .
OBJECTIVE	Is the program more effective and cost-effective than usual care for the prevention of falls ?
METHODS	Single-blinded , two group , cluster randomized trial .
METHODS	300 residents , living in 20 aged care facilities .
METHODS	Progressive resistance and balance training under the guidance of a physiotherapist for 6 months , then facility-guided maintenance training for 6 months .
METHODS	Usual care .
METHODS	Number of falls , number of fallers , quality of life , mobility , balance , fear of falling , cognitive well-being , resource use , and cost-effectiveness .
METHODS	Measurements will be taken at baseline , 6 months , and 12 months .
METHODS	The number of falls will be analyzed using a Poisson mixed model .
METHODS	A logistic mixed model will be used to analyze the number of residents who fall during the study period .
METHODS	Intention-to-treat analysis will be used .
CONCLUSIONS	This study addresses a significant shortcoming in aged care research , and has potential to impact upon a substantial health care problem .
CONCLUSIONS	Outcomes will be used to inform care providers , and guide health care policies .

###24570527
OBJECTIVE	To evaluate the efficacy of early video-assisted thoracoscopic debridement in patients with the fibropurulent phase of parapneumonic empyema .
METHODS	40 patients with parapneumonic empyema resistant to 2 weeks of antibiotic therapy , were randomly divided into 2 groups .
METHODS	In group 1 ( 20 patients ) , antibiotic therapy and irrigation was continued , and in group 2 ( 20 patients ) , video-assisted thoracoscopic debridement was performed .
METHODS	The 2 groups were compared in terms of therapeutic results .
RESULTS	The male/female ratio was 29/11 .
RESULTS	Group 1 included 16 men and 4 women with a mean age of 54 years , and mean hospital stay was 41 days .
RESULTS	Group 2 consisted of 14 men and 6 women with a mean age of 51 years , and mean hospital stay was 23 days .
RESULTS	Considering the therapeutic results , 12 patients in group 1 were cured by antibiotic therapy and irrigation , whereas 8 required decortication and pleurectomy with thoracotomy .
RESULTS	In group 2 , 18 patients were cured by video-assisted thoracoscopic debridement , and 2 underwent thoracotomy and decortication due to intraoperative bleeding .
RESULTS	A significant difference in therapeutic results was noted between the groups ( p = 0.028 ) .
CONCLUSIONS	Video-assisted thoracoscopic debridement provides a high success rate and less invasive treatment for the early stages of empyema .

###24330675
BACKGROUND	Dyspepsia is common among end-stage renal disease ( ESRD ) patients and its association with delayed gastric emptying is not well established .
BACKGROUND	We assessed the association of dyspepsia with gastric emptying time in ESRD patients undergoing hemodialysis ( HD ) .
METHODS	Dyspepsia was assessed through the Porto Alegre Dyspeptic Symptoms Questionnaire ( PADYQ ) .
METHODS	PADYQ 's scores 6 classified participants as dyspeptic .
METHODS	The octanoic acid breath test using carbon was employed to assess the gastric emptying time .
METHODS	Based on the test , time in minutes to metabolize the first half of the carbon in the test meal ( t1/2 ) was calculated .
METHODS	Association of dyspepsia with gastric emptying time was tested by the correlation between PADYQ scores and t1/2 , and also by comparing t1/2 between dyspeptics and non-dyspeptics .
RESULTS	There were 34 ( 68.0 % ) dyspeptic patients .
RESULTS	Dyspepsia score was positively correlated with t1/2 ( r = 0.366 ; p = 0.009 ) .
RESULTS	Dyspeptics had longer t1/2 compared to non-dyspeptics , respectively , 238.0 92.9 versus 185.5 45.5 minutes ( p = 0.042 ) .
CONCLUSIONS	Delayed gastric emptying was associated with dyspepsia .
CONCLUSIONS	Prokinetic medications could have a role in preventing or relieving dyspeptic symptoms among HD patients .
CONCLUSIONS	Future research in larger samples is necessary to confirm this association .

###25102686
OBJECTIVE	To observe the clinical efficacy of Busuishengxue granules on non-severe aplastic anemia ( NSAA ) and investigate its effect on the mitogen-activated protein kinase/extracellular signal-regulated kinase ( MAPK/ERK ) pathway .
METHODS	Sixty NSAA patients were divided equally into two groups .
METHODS	Subjects in the experimental group were treated with Busuishengxue granules , and the control group with Zaizaoshengxue tablets .
METHODS	The treatment course was 6 months and curative efficacy was compared between the two groups as well as with 10 healthy individuals .
METHODS	Flow cytometry ( FCM ) was used to detect the intracellular concentration of Ca2 + ( [ Ca2 + ] i ) .
METHODS	Western blotting was employed to detect the expression of enzymes in the MAPK/ERK pathway .
RESULTS	The efficacy of Busuishengxue granules was significantly better than that of Zaizaoshengxue tablets ( P < 0.05 ) .
RESULTS	Before treatment , expression of JNK , phospho-ERK 1/2 and p-JNK was higher , and [ Ca2 + ] i higher , than that of the control group ( P < 0.05 ) .
RESULTS	After treatment with Busuishengxue granules , expression of all enzymes related to signal transduction pathways in the blood cells of NSSA patients were altered to different degrees .
CONCLUSIONS	Busuishengxue granules had a better effect with regard to improving symptom scores , increasing the number of blood leukocytes , and increasing hemoglobin levels than Zaizaosh-engxue tablets , and they differed slightly in terms of increasing the number of platelets .

###25702375
BACKGROUND	Manual wheelchairs ( MWCs ) can improve mobility and social participation for individuals who experience difficulty walking ; however , older adults receive little training for wheelchair use .
BACKGROUND	The Wheelchair Self-Efficacy Enhanced for Use ( WheelSeeU ) research program provides peer-led training that may positively influence wheelchair use while reducing clinician burden .
OBJECTIVE	The purpose of this study is to evaluate the feasibility and clinical outcomes of WheelSeeU .
METHODS	A randomized control trial ( RCT ) recruits and randomly assigns 40 MWC users ( 55 + years ) .
METHODS	Feasibility indicators assessing process , resource , management , and treatment issues are measured , and clinical outcomes ( wheelchair skills , safety , confidence , mobility , social participation , quality of life , health utility ) are collected at three time points .
CONCLUSIONS	WheelSeeU provides an innovative approach for teaching wheelchair skills to an aging population that may improve wheelchair use and decrease clinician burden .
CONCLUSIONS	Since RCTs are expensive and challenging in rehabilitation , establishing feasibility prior to larger effectiveness trials is prudent .

###24652109
BACKGROUND	Screening for Barrett 's esophagus ( BE ) and adenocarcinoma ( EAC ) is controversial , but interest remains in finding the optimal method .
BACKGROUND	Attitudes on screening within the community are unknown .
BACKGROUND	We aimed to assess these attitudes via a survey .
METHODS	A mixed-mode survey was conducted in adults > 50 years to assess awareness regarding BE , willingness to participate in screening , and preferences regarding method of screening .
METHODS	Methods evaluated were sedated endoscopy ( sEGD ) , unsedated transnasal endoscopy ( uTNE ) and video capsule ( VCE ) .
RESULTS	A total of 136 from 413 ( 33 % ) adults responded [ 47 % males , mean ( SD ) age 63 ( 10.2 ) years ] , and 26 % of responders knew of BE at baseline .
RESULTS	After reading the information on BE , 72 % were interested in screening .
RESULTS	A history of undergoing screening tests and GI symptoms were predictive of interest .
RESULTS	Unsedated techniques were preferred by 64 % ( VCE : 56 % and uTNE : 8 % ) versus sEGD ( 36 % ) .
CONCLUSIONS	The majority of adults were willing to undergo screening for BE/EAC , with a preference for unsedated techniques .

###24629060
OBJECTIVE	Nitric oxide donors , such as isosorbide dinitrate ointment ( ISDN ) , are considered as first-choice agents in the treatment of chronic anal fissure .
OBJECTIVE	Injection with botulinum toxin A in the internal anal sphincter is often used as a second-line therapy , although it may give better results and fewer side effects than nitric oxide donors .
OBJECTIVE	The aim of this randomized clinical trial was to investigate whether botulinum toxin A ( Dysport ) is more effective than ISDN in the primary treatment of chronic anal fissure .
METHODS	From April 2005 until October 2009 , 60 patients ( 32 men ) with a median age of 42 ( 25-82 ) years were randomized to receive either ISDN 10 mg/ml ( 1 % ) ( n = 33 ) or injection with 60 units of Dysport ( n = 27 ) .
METHODS	The primary end-point was the percentage of complete fissure healing after 8 weeks .
RESULTS	After a median of 9 weeks complete fissure healing was noted in 18 of 27 patients in the Dysport group and in 11 of 33 patients in the ISDN group ( P = 0.010 ) .
RESULTS	Absolute improvement of pain scores after 9 weeks was similar in both groups ( P = 0.733 ) .
RESULTS	Patients treated with Dysport had fewer side effects than patients treated with ISDN ( P = 0.028 ) .
RESULTS	Of the patients with a healed fissure , 28 % of the Dysport group and 50 % of the ISDN group had a recurrence within 1 year ( P = 0.286 ; hazard ratio 2.08 ; 95 % CI = 0.54-7 .97 ) .
CONCLUSIONS	Dysport is more effective than ISDN ointment and has fewer side effects in the primary treatment of chronic anal fissure .
CONCLUSIONS	The recurrence rate within 1 year in both treatment groups is high .

###24473774
BACKGROUND	The authors prospectively assessed anxiety , depression , and behavior in children with standard-risk acute lymphoblastic leukemia ( SR-ALL ) during the first year of therapy and identified associated risk factors .
METHODS	A cohort study was performed of 159 children ( aged 2 years-9 .99 years ) with SR-ALL who were enrolled on Children 's Oncology Group protocol AALL0331 at 31 sites .
METHODS	Parents completed the Behavior Assessment System for Children , the General Functioning Scale of the Family Assessment Device , and the Coping Health Inventory for Parents at approximately 1 , 6 , and 12 months after diagnosis .
RESULTS	Overall , mean scores for anxiety , depression , aggression , and hyperactivity were similar to population norms .
RESULTS	However , more children scored in the at-risk/clinical range for depression than the expected 15 % at 1 month ( 21.7 % ; P = .022 ) , 6 months ( 28.6 % ; P < .001 ) , and 12 months ( 21.1 % ; P = .032 ) .
RESULTS	For anxiety , more children scored in the at-risk/clinical range at 1 month ( 25.2 % vs 15 % ; P = .001 ) , but then reverted to expected levels .
RESULTS	On adjusted analysis , unhealthy family functioning was found to be predictive of anxiety ( odds ratio [ OR ] , 2.24 ; P = .033 ) and depression ( OR , 2.40 ; P = .008 ) .
RESULTS	Hispanic ethnicity was associated with anxiety ( OR , 3.35 ; P = .009 ) .
RESULTS	Worse physical functioning ( P = .049 ) , unmarried parents ( P = .017 ) , and less reliance on social support ( P = .004 ) were found to be associated with depression .
RESULTS	Emotional distress at 1 month predicted anxiety ( OR , 7.11 ; P = .002 ) and depression ( OR , 3.31 ; P = .023 ) at 12 months .
CONCLUSIONS	Anxiety is a significant problem in a subpopulation of patients with SR-ALL immediately after diagnosis , whereas depression remains a significant problem for at least 1 year .
CONCLUSIONS	Children of Hispanic ethnicity or those with unhealthy family functioning may be particularly vulnerable .
CONCLUSIONS	These data suggest that clinicians should screen for anxiety and depression throughout the first year of therapy .

###24231843
OBJECTIVE	In a multicenter , prospectively randomized study we evaluated the 5-year outcomes of bacillus Calmette-Gurin alone compared to a combination of epirubicin and interferon-2b in the treatment of patients with T1 bladder cancer .
METHODS	Transurethral resection was followed by a second resection and bladder mapping .
METHODS	Stratification was for grade and carcinoma in situ .
METHODS	Followup entailed regular cystoscopy and cytology during the first 5 years .
METHODS	The end points assessed in this analysis were recurrence-free survival , time to treatment failure and progression , cancer specific survival and prognostic factors .
RESULTS	The study recruited 250 eligible patients .
RESULTS	The 5-year recurrence-free survival rate was 38 % in the combination arm and 59 % in the bacillus Calmette-Gurin arm ( p = 0.001 ) .
RESULTS	The corresponding rates for the other end points were not significantly different , as free of progression 78 % and 77 % , treatment failure 75 % and 75 % , and cancer specific survival 90 % and 92 % , respectively .
RESULTS	The type of treatment , tumor size and tumor status at second resection were independent variables associated with recurrence .
RESULTS	Concomitant carcinoma in situ was not predictive of failure of bacillus Calmette-Gurin therapy .
RESULTS	An independent factor for treatment failure was remaining T1 stage at second resection .
CONCLUSIONS	Bacillus Calmette-Gurin was more effective than the tested combination therapy .
CONCLUSIONS	The currently recommended management with second resection and 3-week maintenance bacillus Calmette-Gurin entails a low risk of cancer specific death .
CONCLUSIONS	More aggressive treatment in patients with infiltrative tumors at second resection might improve these results .
CONCLUSIONS	In particular , concomitant carcinoma in situ was not a predictive factor for poor outcome after bacillus Calmette-Gurin therapy .

###25843821
OBJECTIVE	The Le Fort I osteotomy ( L-I ) requires extensive dissection and manipulation of tissue , causing hemodynamic instability and an undesirable postoperative stress response .
OBJECTIVE	This study aimed to clarify the most effective dose of remifentanil during L-I .
METHODS	This study was designed as a prospective , randomized , controlled double-blinded study .
METHODS	Patients ( American Society of Anesthesiologists physical status I to II ) undergoing L-I were randomly assigned to receive anesthesia with propofol and remifentanil under 3 remifentanil dose conditions : 0.25 g/kg/minute ( group 1 ) , 0.5 g/kg/minute ( group 2 ) , and 0.75 g/kg/minute ( group 3 ) .
METHODS	All patients underwent L-I with propofol and remifentanil target-controlled anesthesia .
METHODS	The study endpoints were mean arterial pressure ( MAP ) and heart rate .
METHODS	Data were recorded before L-I ( 20-minute period before surgery ) , during L-I ( from the beginning of surgery to downfracture ) , and after L-I ( 20-minute period after downfracture ) .
METHODS	Average age , gender , average body mass index , aimed maxillary position , average bispectral index , average surgery time , and average blood loss also were examined .
METHODS	Data were analyzed using the Bartlett test and then 1-way analysis of variance with the Bonferroni multiple comparison test .
RESULTS	Data were obtained from 20 patients ( 9 men , 11 women ) .
RESULTS	The average operating times for groups 1 , 2 , and 3 were 53.1 , 46.7 , and 49minutes , respectively .
RESULTS	The age range was 18 to 46years ( average , 26.05 yr ) .
RESULTS	The rate of MAP increase from before to during L-I in group 1 was 10.8 % ( n = 7 ) .
RESULTS	The rate of MAP increase from before to during L-I in group 3 was 2.1 % ( n = 6 ) .
RESULTS	Group 3 showed a significantly lower rate of MAP increase during and after L-I compared with group 1 ( P < .05 ) .
CONCLUSIONS	Remifentanil administration at 0.75 g/kg/minute stabilized hemodynamics during L-I without major side effects .
CONCLUSIONS	Results indicated that the standard index of remifentanil administration during L-I should be 0.75 g/kg/minute when using oxygen , propofol , and remifentanil for general anesthesia .

###25561192
BACKGROUND	The clamshell incision ( CI ) offers a better exposure than the left anterolateral thoracotomy ( LAT ) as a resuscitative thoracotomy .
BACKGROUND	Most surgeons will have to manage a heart wound only once or twice in their career .
BACKGROUND	The patient 's survival depends on how fast the surgeon can control the heart wound ; however , it is unclear which of the two incisions allows for faster control in the hands of inexperienced surgeons .
BACKGROUND	The aim of this study was to compare the time needed to access and control a standardized stab wound to the right ventricle , by inexperienced surgical trainees , by LAT or CI ; we hypothesized that the CI does not take longer than the LAT .
METHODS	Sixteen residents were shown a video on how to perform both procedures .
METHODS	They were randomly assigned to control a standardized stab wound of the right ventricle on perfused human cadavers by LAT ( n = 8 ) or CI ( n = 8 ) .
METHODS	Access time ( skin to maximal exposure ) , control time ( maximal exposure until control of the heart wound ) and total time ( the sum of access and control times ) were recorded .
RESULTS	Total time was 6.62 min [ 3.20-8 .14 ] ( median [ interquartile range ] ) for LAT and 4.63 min [ 3.17-6 .73 ] for CI ( p = 0.46 ) .
RESULTS	Access time was 2.39 min [ 1.21-2 .76 ] for LAT and 2.33 min [ 1.58-4 .86 ] for CI ( p = 0.34 ) .
RESULTS	Control time was 4.16 min [ 2.32-5 .49 ] for LAT and 1.85 min [ 1.38-2 .23 ] for CI ( p = 0.018 ) .
CONCLUSIONS	The time needed from skin incision until cardiac wound control via CI was not longer than via LAT and the easier control of the cardiac wound when using CI was confirmed .

###24819349
BACKGROUND	The number of total knee replacements performed each year is increasing .
BACKGROUND	Among the main impediments to functional recovery after these surgeries include postoperative edema , pain , lower limb muscle strength deficits , all of which point to a need to identify safe , effective postoperative rehabilitation modalities .
OBJECTIVE	The aim of this paper was to evaluate the effectiveness of Kinesio Taping ( KT ) method in reducing postoperative pain , edema , and improved knee range of motion recovery after total knee replacement ( TKR ) operation in early postoperative rehabilitation period .
METHODS	Randomized clinical trial .
METHODS	Inpatient rehabilitation facility .
METHODS	Ninety-four patients , who underwent primary TKR surgery .
METHODS	Using simple randomization , participants were divided into KT group and control group .
METHODS	Both groups received same rehabilitation program and procedures after surgery , except KT group also received KT applications throughout all rehabilitation period .
METHODS	Postoperative pain , edema , restoration of the operated knee flexion and extension were evaluated .
METHODS	The chosen level of significance was P < 0.05 ; in evaluation power of the test 0.2 .
METHODS	Groups were homogenous to sex , age , BMI , comorbidities , preoperative knee flexion/extension impairment , preoperative pain intensity , anaesthesia , prosthesis implanted ( P > 0.05 ) .
RESULTS	In both groups postoperative pain decreased significantly during rehabilitation period , however less pain was found in KT group from the second postoperative week till the end of inpatient rehabilitation ( 28th postoperative day ) ( P < 0.05 ; 0.2 ) .
RESULTS	Postoperative edema was less intense and subsided more quickly in KT group as well ( P < 0.05 ; 0.2 ) .
RESULTS	No difference was found in improvement of knee flexion ( P > 0.05 ) .
RESULTS	Operated knee extension was found better in KT group then in control at the end of in-patient rehabilitation ( P < 0.05 ; 0.2 ) .
RESULTS	KT was well tolerated by patients .
CONCLUSIONS	KT technique appeared to be beneficial for reducing postoperative pain , edema , improving knee extension in early postoperative rehabilitation period .
CONCLUSIONS	This finding implies for health care professionals working in the field of physical medicine and rehabilitation that Kinesio Taping method is safe and can be used as additional rehabilitation means for patients after TKR .

###24689258
OBJECTIVE	A pair of simulated driving experiments studied the effects of cognitive load on drivers ' lane-keeping performance .
BACKGROUND	Cognitive load while driving often reduces the variability of lane position .
BACKGROUND	However , there is no agreement as to whether this effect should be interpreted as a performance loss , consistent with other effects of distraction on driving , or as an anomalous performance gain .
METHODS	Participants in a high-fidelity driving simulator performed a lane-keeping task in lateral wind , with instructions to keep a steady lane position .
METHODS	Under high load conditions , participants performed a concurrent working memory task with auditory stimuli .
METHODS	Cross-spectral analysis measured the relationship between wind force and steering inputs .
RESULTS	Cognitive load reduced the variability of lane position and increased the coupling between steering wheel position and crosswind strength .
CONCLUSIONS	Although cognitive load disrupts driver performance in a variety of ways , it produces a performance gain in lane keeping.This effect appears to reflect drivers ' efforts to protect lateral control against the risk of distraction , at the apparent neglect of other elements of driving performance .
CONCLUSIONS	Results may inform educational efforts to help drivers understand the risks of distraction and the inadequacies of compensatory driving strategies .

###24534139
BACKGROUND	Setting a target quit date ( TQD ) is often an important component in smoking cessation treatment , but ambiguity remains concerning the optimal timing ( ie , quitting spontaneously versus delaying to prepare ) .
OBJECTIVE	We examined four questions about the timing of TQDs and smoking outcomes in secondary analyses of The iQUITT Study , a randomized trial of Internet and telephone treatment for cessation : ( 1 ) What are the characteristics of TQDs set using an online interactive quit date tool ?
OBJECTIVE	, ( 2 ) What are the characteristics of individuals who use a quit date tool and do they differ from those who do not ?
OBJECTIVE	, ( 3 ) Are there differences in smoker characteristics , treatment utilization , and cessation outcomes based TQD timing ?
OBJECTIVE	, and ( 4 ) Is maintenance of an initial TQD predictive of abstinence or do changes to TQDs lead to cessation ?
METHODS	A total of 825 adult current cigarette smokers were randomized to enhanced Internet or enhanced Internet plus telephone counseling .
METHODS	Latency to TQD in days was calculated as the date difference between the initial TQD and enhanced Internet registration ; prospective TQD setters were stratified into four latency groups ( 0 , 1-14 , 15-28 , 29 + days ) .
METHODS	Baseline variables , website utilization , and 3-month cessation outcomes were examined between prospective TQD groups .
METHODS	Desire and confidence to quit , number of TQDs , and website logins were tested as predictors of 30-day point prevalence abstinence ( ppa ) at 3 months ( responder-only analyses ) .
METHODS	Classification and regression tree ( CART ) analysis explored interactions among baseline variables , website utilization , and latency to TQD as predictors of 30-day ppa .
RESULTS	There were few baseline differences between individuals who used the quit date tool and those who did not .
RESULTS	Prospective TQDs were set as follows : registration day was 17.1 % ( 73/427 ) , 1-14 days was 37.7 % ( 161/427 ) , 15-28 days was 18.5 % ( 79/427 ) , and 29 + days was 26.7 % ( 114/427 ) .
RESULTS	Participants with a TQD within 2 weeks had higher baseline self-efficacy scores but did not differ on smoking variables .
RESULTS	Individuals whose TQD was the same day as registration had the highest logins , page views , number of TQDs set using the tool , and messages sent to other members .
RESULTS	Logistic regression revealed a significant interaction between number of TQDs and website logins for 30-day ppa ( P = .005 ) .
RESULTS	Among those with high logins , 41.8 % ( 33/79 ) with 1 TQD were abstinent versus 25.9 % ( 35/135 ) with 2 + TQDs .
RESULTS	Logins and self-efficacy predicted 30-day ppa in the CART model .
CONCLUSIONS	TQD timing did not predict cessation outcomes in standard or exploratory analyses .
CONCLUSIONS	Self-efficacy and an apparent commitment to an initial TQD were the components most highly related to abstinence but only via interactions with website utilization .
CONCLUSIONS	Findings highlight the importance of feeling efficacious about handling specific smoking situations and engaging with treatment .
CONCLUSIONS	Additional research focused on increasing engagement in Web-based cessation studies is needed .
BACKGROUND	ClinicalTrials.gov : NCT00282009 ; http://clinicaltrials.gov/show/NCT00282009 ( Archived by WebCite at http://www.webcitation.org/6Kt7NrXDl ) .

###24856464
OBJECTIVE	To compare the effectiveness and patient preference of different routes of misoprostol administration before operative hysteroscopy in premenopausal women .
METHODS	Randomized , controlled trial .
METHODS	University hospital .
METHODS	One hundred sixty women undergoing operative hysteroscopy .
METHODS	Patients were randomly assigned to receive 400 g misoprostol orally ( n = 40 ) , sublingually ( n = 40 ) , or vaginally ( n = 40 ) before operative hysteroscopy ; the control group ( n = 40 ) did not receive any cervical priming agent .
METHODS	Preoperative cervical width , adverse effects , and patient preference .
RESULTS	The mean ( SD ) cervical widths for the oral , sublingual , vaginal , and control groups were 7.621.81 mm , 7.581.77 mm , 7.602.15 mm , and 5.652.12 mm , respectively , which was statistically significant .
RESULTS	Time to cervical dilatation was also significantly longer in the control group than in the other three groups .
RESULTS	Misoprostol-related adverse effects and hysteroscopy-related complications were comparable among the four study groups .
RESULTS	Of all 160 subjects , 132 ( 82 % ) preferred the oral route for misoprostol administration to the sublingual or vaginal routes , or had no preference .
CONCLUSIONS	All orally , sublingually , and vaginally administrated misoprostol is equally effective in inducing proper cervical priming before operative hysteroscopy .
CONCLUSIONS	Considering patient preference , oral administration may be the optimal route for misoprostol administration .
BACKGROUND	NCT01805115 .

###25831646
OBJECTIVE	To evaluate and determine the effectiveness of surgical excision , aspiration and injection in the treatment of symptomatic ganglions .
METHODS	The prospective randomized control trial based on non-probability convenience sampling was conducted at the Department of Surgery , Combined Military Hospital , Sialkot , from June 2007 to August 2010 , and at the Department of Surgery , Islam Teaching Hospital , Sialkot , from September 2010 to December 2012 .
METHODS	The last patient was included in June 2012 .
METHODS	Adult patients referred by general practitioners with ganglia of wrist , ankle and knee were included .
METHODS	All the patients were offered treatment options of intralesional steroid injection or excision of ganglion.The study population was distributed in two groups : Group I opted for aspiration and injection treatment , while Group II went for surgical treatment .
METHODS	A minimum follow-up of six months was mandatory for inclusion in the study .
METHODS	Data was compared and analyzed using SPSS version 22 .
RESULTS	The study had 173 patients with 187 ganglia .
RESULTS	Group I had 143 ( 76.4 % ) patients , while Group II had 44 ( 23.3 % ) .
RESULTS	In the short term , 82 ( 57.3 % ) of the patients achieved complete resolution after one episode of aspiration and injection , and success rate after second injection repeated after 3 weeks was 116 ( 81 % ) .
RESULTS	Overall success rate of aspiration and injection of Triamcinolone acetonide six months after the treatment was 116 ( 81 % ) .
RESULTS	On the surgical side the success rate was 41 ( 93 % ) .
RESULTS	Complications like pain , joint stiffness and ugly scar were few and not significant .
RESULTS	Comparison of failure rates of the two groups ( 19 % vs 7 % ) showed significant difference ( p < 0.028 ) .
CONCLUSIONS	In symptomatic ganglia , surgical excision was a better treatment option as the failure rate was less compared to injection-aspiration .
CONCLUSIONS	The injection treatment should be offered to those who are not willing for surgery , but they should be properly counselled about the chances of failure .

###24908096
BACKGROUND	Parkinson 's disease is a common movement disorder affecting approximately 127,000 people in the UK , with an estimated two thirds having speech-related problems .
BACKGROUND	Currently there is no preferred approach to speech and language therapy within the NHS and there is little evidence for the effectiveness of standard NHS therapy or Lee Silverman voice treatment .
BACKGROUND	This trial aims to investigate the feasibility and acceptability of randomizing people with Parkinson 's disease-related speech or voice problems to Lee Silverman voice treatment or standard speech and language therapy compared to a no-intervention control .
METHODS	The PD COMM pilot is a three arm , assessor-blinded , randomized controlled trial .
METHODS	Randomization will be computer-generated with participants randomized at a ratio of 1:1:1 .
METHODS	Participants randomized to intervention arms will be immediately referred to the appropriate speech and language therapist .
METHODS	The target population are patients with a confirmed diagnosis of idiopathic Parkinson 's disease who have problems with their speech or voice .
METHODS	The Lee Silverman voice treatment intervention group will receive the standard regime of 16 sessions between 50 and 60minutes in length over four weeks , with extra home practice .
METHODS	The standard speech and language therapy intervention group will receive a dose determined by patients ' individual needs , but not exceeding eight weeks of treatment .
METHODS	The control group will receive standard care with no speech and language therapy input for at least six months post-randomization .
METHODS	Outcomes will be assessed at baseline ( pre-randomization ) and post - randomization at three , six , and 12months .
METHODS	The outcome measures include patient-reported voice measures , quality of life , resource use , and assessor-rated speech recordings .
METHODS	The recruitment aim is at least 60 participants over 21months from 11 sites , equating to at least 20 participants in each arm of the trial .
METHODS	This trial is ongoing and recruitment commenced in May 2012 .
CONCLUSIONS	This study will provide information on the feasibility and acceptability of randomizing participants to different speech and language therapies or control/deferred treatment .
CONCLUSIONS	The findings relating to recruitment , treatment compliance , outcome measures , and effect size will inform a future phase III randomized controlled trial .
BACKGROUND	International Standard Randomised Controlled Trial Number Register : ISRCTN75223808 registered 22 March 2012 .

###24757146
OBJECTIVE	To compare the effects of neuromuscular exercise ( NEXA ) and quadriceps strengthening ( QS ) on the knee adduction moment ( an indicator of mediolateral distribution of knee load ) , pain , and physical function in patients with medial knee joint osteoarthritis ( OA ) and varus malalignment .
METHODS	One hundred patients with medial knee pain , mostly moderate-to-severe radiographic medial knee OA , and varus malalignment were randomly allocated to one of two 12-week exercise programs .
METHODS	Each program involved 14 individually supervised exercise sessions with a physiotherapist plus a home exercise component .
METHODS	Primary outcomes were peak external knee adduction moment ( 3-dimensional gait analysis ) , pain ( visual analog scale ) , and self-reported physical function ( Western Ontario and McMaster Universities Osteoarthritis Index ) .
RESULTS	Eighty-two patients ( 38 [ 76 % ] of 50 in the NEXA group and 44 [ 88 % ] of 50 in the QS group ) completed the trial .
RESULTS	There was no significant between-group difference in the change in the peak knee adduction moment ( mean difference 0.13 Nm / [ body weight height ] % [ 95 % confidence interval ( 95 % CI ) -0.08 , 0.33 ] ) , pain ( mean difference 2.4 mm [ 95 % CI -6.0 , 10.8 ] ) , or physical function ( mean difference -0.8 units [ 95 % CI -4.0 , 2.4 ] ) .
RESULTS	Neither group showed a change in knee moments following exercise , whereas both groups showed similar significant reductions in pain and improvement in physical function .
CONCLUSIONS	Although comparable improvements in clinical outcomes were observed with both neuromuscular and quadriceps strengthening exercise in patients with moderate varus malalignment and mostly moderate-to-severe medial knee OA , these forms of exercise did not affect the knee adduction moment , a key predictor of structural disease progression .

###24823873
BACKGROUND	The purpose of this study was to evaluate the advantages of exenatide treatment on obesity and non-alcoholic fatty liver disease ( NAFLD ) with elevated liver enzymes in patients with type 2 diabetes ( T2D ) .
METHODS	A total of 60 newly diagnosed patients with obesity , NAFLD with elevated liver enzymes and T2D were included in the study .
METHODS	The patients were randomly divided into two groups .
METHODS	The exenatide treatment group ( n = 30 ) were treated with exenatide and insulin glargine , and the intensive insulin therapy group ( n = 30 ) were treated with insulin aspart and insulin glargine for 12weeks .
METHODS	Selected clinical characteristics were determined , and ultrasonography was performed at both baseline and 12weeks following treatment .
RESULTS	At baseline , the clinical characteristics were matched between the two groups .
RESULTS	After 12weeks , fasting blood glucose ( FBG ) , postprandial blood glucose ( PBG ) , glycosylated haemoglobin ( HbA1c ) , total cholesterol ( TC ) , triglyceride ( TG ) and total bilirubin levels were significantly decreased in the two groups ( p < 0.001 ) .
RESULTS	Body weight and waist circumference were significantly decreased in the exenatide group but increased in the intensive insulin group ( p < 0.001 ) .
RESULTS	The levels of alanine aminotransferase ( ALT ) , aspartate aminotransferase ( AST ) and - glutamyl transpeptidase ( GGT ) in the exenatide group were significantly lower than in the intensive insulin group ( p < 0.001 ) .
RESULTS	The mean body weight change correlated with the levels of ALT , AST and GGT change ( ALT , r = 0.761 ; AST , r = 0.733 ; GGT , r = 0.752 ; p < 0.001 ) .
RESULTS	Moreover , the reversal rate of fatty liver was significantly higher in the exenatide group ( 93.3 % ) than the intensive insulin group ( 66.7 % ) ( p < 0.01 ) .
CONCLUSIONS	Exenatide has a better hepatic-protective effect than intensive insulin therapy and perhaps represents a unique option for adjunctive therapy for patients with obesity , non-alcoholic fatty liver disease with elevated liver enzymes and T2D .

###24561145
OBJECTIVE	This study sought to determine the frequency and impact of coronary calcification among patients undergoing percutaneous coronary intervention ( PCI ) for acute coronary syndromes ( ACS ) .
BACKGROUND	Small studies in patients with stable coronary artery disease have suggested a worse prognosis after PCI of calcified compared with noncalcified lesions .
BACKGROUND	Little is known about the impact of coronary calcification on outcomes after PCI for patients presenting with non-ST-segment elevation and ST-segment elevation ACS .
METHODS	Data from 6,855 patients presenting with ACS in whom PCI was performed were pooled from 2 large-scale randomized , controlled trials , ACUITY ( Acute Catheterization and Urgent Intervention Triage Strategy ) and HORIZONS-AMI ( Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction ) .
METHODS	One-year outcomes were analyzed according to the severity of PCI target lesion calcification ( none/mild , moderate , or severe ) as assessed by an independent angiographic core laboratory .
RESULTS	Target lesion calcification was severe in 402 patients ( 5.9 % ) , moderate in 1,788 ( 26.1 % ) , and none/mild in 4,665 ( 68.1 % ) .
RESULTS	Moderate/severe target lesion calcification was more frequent in older patients , men , hypertensive patients , and those presenting with ST-segment elevation myocardial infarction ( STEMI ) .
RESULTS	The unadjusted 1-year rates of death , cardiac death , definite stent thrombosis , and ischemic target lesion revascularization ( TLR ) and target vessel revascularization were significantly increased in patients with moderate/severe target lesion calcification .
RESULTS	By multivariable analysis , the presence of moderate/severe target lesion calcification was an independent predictor of 1-year definite stent thrombosis ( hazard ratio [ HR ] : 1.62 ; 95 % confidence interval [ CI ] : 1.14 to 2.30 ; p = 0.007 ) and ischemic TLR ( HR :1.44 ; 95 % CI : 1.17 to 1.78 ; p = 0.0007 ) .
CONCLUSIONS	Moderate/severe lesion calcification was relatively frequent in patients with non-ST-segment elevation ACS and STEMI and was strongly predictive of stent thrombosis and ischemic TLR at 1 year .
CONCLUSIONS	( Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes [ ACS ] ; NCT00093158 ; Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction ; NCT00433966 ) .

###24853308
BACKGROUND	The potential epidemiological impact of isoniazid preventive therapy ( IPT ) , delivered at levels that could be feasibly scaled up among people living with HIV ( PLHIV ) in modern , moderate-burden settings , remains uncertain .
METHODS	We used routine surveillance and implementation data from a cluster-randomized trial of IPT among HIV-infected clinic patients with good access to antiretroviral therapy in Rio de Janeiro , Brazil , to populate a parsimonious transmission model of tuberculosis ( TB ) / HIV .
METHODS	We modeled IPT delivery as a constant process capturing a proportion of the eligible population every year .
METHODS	We projected feasible reductions in TB incidence and mortality in the general population and among PLHIV specifically at the end of 5 years after implementing an IPT program .
RESULTS	Data on time to IPT fit an exponential curve well , suggesting that IPT was delivered at a rate covering 20 % ( 95 % confidence interval : 16 % to 24 % ) of the 2500 eligible individuals each year .
RESULTS	By the end of year 5 after modeled program rollout , IPT had reduced TB incidence by 3.0 % [ 95 % uncertainty range ( UR ) : 1.6 % to 7.2 % ] in the general population and by 15.6 % ( 95 % UR : 15.5 % to 36.5 % ) among PLHIV .
RESULTS	Corresponding reductions in TB mortality were 4.0 % ( 95 % UR : 2.2 % to 10.3 % ) and 14.3 % ( 14.6 % to 33.7 % ) .
RESULTS	Results were robust to wide variations in parameter values on sensitivity analysis .
CONCLUSIONS	TB screening and IPT delivery can substantially reduce TB incidence and mortality among PLHIV in urban , moderate-burden settings .
CONCLUSIONS	In such settings , IPT can be an important component of a multi-faceted strategy to feasibly reduce the burden of TB in PLHIV .

###24947595
OBJECTIVE	To investigate in a randomized , double-blind design , cumulative effects of anodal tDCS on EEG oscillations and neuropsychological tests among patients with traumatic brain injury ( TBI ) undergoing subacute neurorehabilitation .
METHODS	Twenty-six patients were randomly assigned to active ( n = 13 ) or sham ( n = 13 ) tDCS groups .
METHODS	EEGs were recorded at 6 different time points , assessing both immediate and cumulative effects of tDCS on EEG oscillations .
METHODS	Twenty minute sessions of 1mA anodal stimulation to the left dorsolateral prefrontal cortex ( F3 , cathode placed at right supraorbital site , Fp2 ) , were provided on 10 consecutive days .
METHODS	Neuropsychological tests were administered before and after the series of tDCS sessions .
RESULTS	Theta was significantly reduced for active tDCS patients following the first tDCS session .
RESULTS	Delta decreased and alpha increased , both significantly , for the active tDCS group after 10 consecutive tDCS sessions .
RESULTS	No significant changes were seen for sham group .
RESULTS	Decreases in delta were significantly correlated with improved performance on neuropsychological tests for the active tDCS group to far greater degree than for the sham group .
RESULTS	Participants in the active tDCS group who had excess slow EEG activity in their initial recordings showed greater improvement on neuropsychological tests than other groups .
CONCLUSIONS	Results suggest that 10 anodal tDCS sessions may beneficially modulate regulation of cortical excitability for patients with TBI .
CONCLUSIONS	EEG-guided tDCS warrants further investigation as a potential intervention for TBI during subacute neurorehabilitation .

###25187111
BACKGROUND	This study aimed at assessing the effects of a self-regulation-based brief physical activity program for patients suffering from unexplained chronic fatigue , the `` 4-STEPS to control your fatigue program '' .
METHODS	A 12-week randomized controlled trial was conducted .
METHODS	Adult patients meeting the CDC criteria for idiopathic chronic fatigue were randomized to either the control condition ( standard care ) or the intervention condition ( 4-STEPS ) .
METHODS	The 4-STEPS was based on self-regulation principles and consisted of motivational interviewing and self-regulation skills training .
METHODS	All patients were assessed at baseline and post-treatment ( 12 weeks ) for fatigue severity ( primary outcome ) and impact , physical activity ( leisure time physical activity , number of daily steps and personal activity goal progress ) , health-related quality of life , somatic distress and psychological distress ( depression and anxiety ) .
RESULTS	Ninety-one patients ( 45 intervention and 46 control patients ) received the allocated intervention .
RESULTS	At post-treatment , statistical analysis revealed a significant difference for subjective experience of fatigue ( 4.73 points ; g = 0.51 ) in favour of the intervention group .
RESULTS	Mixed design ANCOVAs showed a significant effect of the 4-STEPS on fatigue severity , leisure time physical activity , personal activity goal progress and health-related quality of life .
RESULTS	No significant effects were found for number of daily steps and somatic and psychological distress .
CONCLUSIONS	The 4-STEPS program has significant beneficial effects at post-treatment .
CONCLUSIONS	This brief self-regulation-based intervention looks promising for the management of unexplained chronic fatigue .
BACKGROUND	ISRCTN70763996 .

###26093863
BACKGROUND	Patients undergoing coronary artery bypass grafting ( CABG ) are still at significant risk for postoperative major adverse cardiac and cerebrovascular events ( MACCEs ) .
BACKGROUND	Recent clinical evidence shows that cardioprotection in patients receiving a chronic statin treatment can be `` recaptured '' by a high-dose statin therapy given shortly before an ischemia-reperfusion sequence .
BACKGROUND	Evaluation of this novel therapeutic approach in the setting of CABG seems promising because myocardial ischemia-reperfusion injury plays a pivotal role in poor clinical outcomes that may be improved by a simple preoperative statin recapture treatment .
METHODS	The investigator-initiated StaRT-CABG trial is a multicenter , randomized , double-blinded , 2-parallel group controlled clinical study in 2,630 patients .
METHODS	The trial aims to evaluate whether a high-dose statin recapture therapy given shortly before CABG reduces the incidence of MACCE at 30 days after surgery ( primary composite outcome : all-cause mortality , nonfatal myocardial infarction , and cerebrovascular events ) .
METHODS	Consenting patients who are on chronic statin therapy before surgery will be randomized to receive either oral statin reloading therapy or matching placebo 12 and 2 hours before CABG .
METHODS	Key secondary end points include enzymatic myocardial injury ; new-onset atrial fibrillation ; length of stay in the intensive care unit and hospital ; need for repeat coronary revascularization at 30 days ; and , finally , all-cause mortality at 12 months after surgery .
CONCLUSIONS	The StaRT-CABG trial is expected to provide highly relevant clinical data on the efficacy of this novel therapeutic approach to optimize the care for patients with coronary artery disease undergoing CABG .

###24614759
BACKGROUND	Mumps , a communicable , acute and previously well-controlled disease , has had recent and occasional resurgences in some areas .
METHODS	A randomized , double-blind , controlled and multistep phase I study of an F-genotype attenuated mumps vaccine produced in human diploid cells was conducted .
METHODS	A total of 300 subjects were enrolled and divided into 4 age groups : 16-60 years , 5-16 years , 2-5 years and 8-24 months .
METHODS	The groups were immunized with one injection per subject .
METHODS	Three different doses of the F-genotype attenuated mumps vaccine , A ( 3.5 0.25 logCCID50 ) , B ( 4.25 0.25 logCCID50 ) and C ( 5.0 0.25 logCCID50 ) , as well as a placebo control and a positive control of a licensed A-genotype vaccine ( S79 strain ) were used .
METHODS	The safety and immunogenicity of this vaccine were compared with those of the controls .
RESULTS	The safety evaluation suggested that mild adverse reactions were observed in all groups .
RESULTS	No serious adverse event ( SAE ) was reported throughout the trial .
RESULTS	The immunogenicity test showed a similar seroconversion rate of the neutralizing and ELISA antibody in the 2 - to 5-year-old and 8 - to 24-month-old groups compared with the seroconversion rate in the positive control .
RESULTS	The GMT of the neutralizing anti-F-genotype virus antibodies in the vaccine groups was slightly higher than that in the positive control group .
CONCLUSIONS	The F-genotype attenuated mumps vaccine evaluated in this clinical trial was demonstrated to be safe and have effective immunogenicity vs. control .

###25208616
BACKGROUND	This study addressed the problem of evaluating the effectiveness of two protocols of physiotherapy for functional recovery after stroke .
BACKGROUND	In particular , the study explored the use of Functional Principal Component Analysis ( FPCA ) , a multivariate data analysis in order to assess and clarify the process of regaining independence after stroke .
METHODS	A randomized double-blind controlled trial was performed .
METHODS	Thirteen subjects with residual hemiparesis after a single stroke episode were measured in both in - and outpatient settings at a district hospital .
METHODS	All subjects were able to walk before suffering the stroke and were hemodynamically stable within the first week after stroke .
METHODS	Control and target groups were treated with conventional physiotherapy for stroke , but specific techniques were added for treatment of the target group depending on patients ' functional levels.Independence level was assessed with the Barthel Index ( BI ) throughout 7 evolution stages ( hemodynamic stability , beginning of standing , beginning of physical therapy sessions in the physiotherapy ward and monthly assessment for 6 months after stroke ) .
RESULTS	FPCA was applied for data analysis .
RESULTS	Statistically significant differences were found in the dynamics of the recovery process between the two physiotherapy protocols .
RESULTS	The target group showed a trend of improvement six months after stroke that was not present in the control group .
CONCLUSIONS	FPCA is a method which may be used to provide greater insight into the analysis of the rehabilitation process than that provided by conventional parametric methods .
CONCLUSIONS	So , by using the whole curves as basic data parameters , subtle differences in the rehabilitation process can be found.FPCA represents a future aid for the fine analysis of similar physiotherapy techniques , when applied in subjects with a huge variability of functional recovery , as in the case of post-stroke patients .

###25074384
METHODS	There is a growing interest in food constituents that could reduce intestinal glucose absorption to prevent overshooting plasma glucose and insulin levels in patients with prediabetes and diabetes mellitus type 2 .
RESULTS	We here demonstrate that an extract and individual polyphenols from apple diminish sodium-coupled glucose transporter 1 ( SGLT1 ) mediated glucose uptake in vitro and in vivo .
RESULTS	Inhibition of transport of sugars by SGLT1 was shown in Xenopus oocytes and in mice jejunal segments .
RESULTS	Strongest inhibition was observed for phlorizin with IC50 values for transport inhibition of 0.46 0.19 and 4.1 0.6 M in oocytes and intestinal segments , respectively .
RESULTS	An oral glucose tolerance test performed in volunteers with prior administration of the apple extract reduced venous blood glucose and plasma insulin levels , similar to findings obtained in C57BL/6N mice .
RESULTS	Analysis of human urine samples revealed that the extract increased modestly renal glucose loss that is most likely a result of inhibition of renal glucose reabsorption by phloretin derivatives found in plasma of the volunteers .
CONCLUSIONS	Although the apple extract substantially decreased intestinal glucose absorption in all test systems , the finding that there are systemic effects that relate to inhibition of glucose transport processes beyond the intestine addresses safety issues that need further exploitation .

###25518299
BACKGROUND	Hypertrophic scar development after median sternotomy wound in cardiac surgery patients is quite common in surgical practice and becomes a major concern nowadays .
OBJECTIVE	To compare cosmetic outcome between different suture materials and different suture techniques for skin closure in median sternotomy wound .
METHODS	A randomized clinical trial was conducted in 80 patients who underwent cardiac surgery in Thammasat University Hospital , Thailand .
METHODS	In respect of the materials and the techniques used to suture the skin , the patients were randomly allocated to four groups .
METHODS	In group 1 , the skin was closed with subcuticular running 4-0 Poliglecaprone 25 ( Monocryl ) .
METHODS	In group 2 , the skin was closed with subcuticular running 4-0 Polydioxanone ( PDS ) .
METHODS	In group 3 , the skin was closed with subcuticular running 4-0 Poliglecaprone 25 ( Monocryl ) and running horizontal mattress 6-0 Nylon .
METHODS	In group 4 , the skin was closed with subcuticular running 4-0 Polydioxanone ( PDS ) and running horizontal mattress 6-0 Nylon .
METHODS	Postoperative evaluation was performed at 2 and 6 weeks , 3 and 6 months follow-up visits .
METHODS	The scar was analyzed in three parts : upper , middle and lower one third of the sternal wound .
METHODS	The outcome measures for surgical wound were width , height and overall appearance of the scar using the Vancouver scar scale ( VSS ) .
METHODS	A linear visual analogue score ( VAS ) was preformed to assess pain and itch .
RESULTS	At 6 months , there were no significant differences between 4 groups ofpatients in every parameters ( width , height , VSS , pain score and itch score ) at three different wound sites ( upper middle and lower ) .
RESULTS	There was a statistically significant and progressive increase in scar stretching , height and total VSSfrom top to bottom of the sternum with the same pattern in all groups ofpatients ( p < 0.05 ) .
RESULTS	At 6 months , scar showed a statistically significant difference in width when compares to6 weeks and 3 months ( p < O. 001 ) .
RESULTS	Female had a statistically significant difference ofscar stretching at upper two third of the sternum ( p < 0.05 ) .
RESULTS	Female scar width was approximately 2folds greater than male patient .
RESULTS	Duringfollow-up in group 3 , two patients died postoperatively due to multi-organ failure and one patient developed wound infection .
CONCLUSIONS	There were no significant differences in cosmetic outcomes between different suture materials and different suture techniques .

###25196301
BACKGROUND	This study was conducted to evaluate the effects of daily consumption of synbiotic bread on the metabolic status of patients with type 2 diabetes mellitus .
METHODS	This randomized , double-blind , controlled clinical trial was performed in 81 diabetic patients .
METHODS	The subjects were randomly assigned to consumption of synbiotic ( n = 27 ) , probiotic ( n = 27 ) , or control bread ( n = 27 ) for 8 weeks 3 times a day in a 40-gram package .
METHODS	The synbiotic bread contained Lactobacillus sporogenes ( 1 10 ( 8 ) CFU ) and 0.07 g inulin per 1 g.
METHODS	The probiotic bread contained L. sporogenes ( 1 10 ( 8 ) CFU per 1 g ) .
METHODS	Fasting blood samples were taken at baseline and after an 8-week intervention for quantification of related factors .
RESULTS	Consumption of the synbiotic bread resulted in a significant reduction in serum insulin levels ( -3.2 5.4 vs. -0.3 3.4 and 0.6 4.7 IU/ml , respectively , p = 0.007 ) , homeostatic model assessment for insulin resistance scores ( -1.5 2.7 vs. -0.2 1.6 and 0.4 3.5 , respectively , p = 0.03 ) , and homeostatic model assessment -- cell function ( -7.2 16.3 vs. -0.7 10.8 and 0.7 8.2 , respectively , p = 0.04 ) compared to the probiotic and control breads .
RESULTS	We did not find any significant effect of synbiotic bread consumption on fasting plasma glucose , the quantitative insulin sensitivity check index , or serum hs-CRP levels compared to other breads .
CONCLUSIONS	Consumption of the synbiotic bread among diabetic patients had beneficial effects on insulin metabolism .

###24229676
BACKGROUND	Hypertension is an important issue in Asia , responsible for up to 66 % of cardiovascular disease cases .
BACKGROUND	This randomized controlled trial subgroup analysis compared telmisartan 80 mg ( T80 ) / hydrochlorothiazide 25 mg ( H25 ) singlepill combination with T80 monotherapy , specifically in Chinese and Korean patients .
METHODS	Patients with grade 2/3 hypertension were randomized to receive telmisartan 40 mg ( T40 ) / hydrochlorothiazide 12.5 mg ( H12 .5 ) combination or T40 monotherapy for one week , before uptitrating the dose to T80/H25 or T80 , respectively , for the remaining 6 weeks .
METHODS	The primary endpoint was systolic blood pressure ( SBP ) mean change from baseline .
METHODS	Secondary endpoints included mean diastolic blood pressure ( DBP ) change from baseline , and blood pressure ( BP ) goal achievement .
METHODS	Adverse events were recorded .
RESULTS	Of a total 888 patients who were treated , efficacy analyses for Chinese and Korean patients included 127 patients treated with T80/H25 and 54 patients treated with T80 .
RESULTS	At week 7 , mean SBP reductions from baseline were -37.5 mmHg ( 1 mmHg = 0.133 kPa ) and -26.9 mmHg in the T80/H25 and T80 groups ( adjusted mean difference , -10.6 mmHg ; 95 % confidence interval ( CI ) , -15.6 to -5.7 ) .
RESULTS	Mean DBP reductions were -19.0 and -14.1 mmHg in the T80/H25 and T80 groups ( adjusted mean difference , -4.9 mmHg ; 95 % CI , -8.0 to -1.8 ) .
RESULTS	In total , 56.7 % of patients receiving T80/H25 achieved BP goal ( < 140/90 mmHg ) compared with 35.2 % receiving T80 .
RESULTS	SBP goal attainment ( < 140 mmHg ) and DBP goal attainment ( < 90 mmHg ) were also higher in the T80/H25 group compared with the T80 group ( SBP : 69.3 % vs. 48.1 % ; DBP : 62.2 % vs. 46.3 % ) .
RESULTS	A small number of treatment-related adverse events were observed in both T80/H25 ( nine patients , 6.9 % ) and T80 monotherapy ( two patients , 3.6 % ) groups .
CONCLUSIONS	In Chinese and Korean patients with moderate-to-severe hypertension , treatment with T80/H25 provided large reductions in mean SBP and DBP , and high BP goal attainment rates .
CONCLUSIONS	This once-daily combination is effective and well tolerated in this patient group .

###24423117
BACKGROUND	High density lipoproteins ( HDL ) have many cardioprotective roles ; however , in subjects with type 2 diabetes ( T2D ) these cardioprotective properties are diminished .
BACKGROUND	Conversely , increased fruit and vegetable ( F&V ) intake may reduce cardiovascular disease risk , although direct trial evidence of a mechanism by which this occurs in subjects with T2D is lacking .
BACKGROUND	Therefore , the aim of this study was to examine if increased F&V consumption influenced the carotenoid content and enzymes associated with the antioxidant properties of HDL in subjects with T2D .
METHODS	Eighty obese subjects with T2D were randomised to a 1 - or 6-portion/dayF & V diet for 8-weeks .
METHODS	Fasting serum was collected pre - and post-intervention .
METHODS	HDL was subfractionated into HDL2 and HDL3 by rapid ultracentrifugation .
METHODS	Carotenoids were measured in serum , HDL2 and HDL3 by high performance liquid chromatography .
METHODS	The activity of paraoxonase-1 ( PON-1 ) was measured in serum , HDL2 and HDL3 by a spectrophotometric assay , while the activity of lecithin cholesterol acyltransferase ( LCAT ) was measured in serum , HDL2 and HDL3 by a fluorometric assay .
RESULTS	In the 6 - vs. 1-portion post-intervention comparisons , carotenoids increased in serum , HDL2 and particularly HDL3 , ( - carotene , p = 0.008 ; - cryptoxanthin , p = 0.042 ; lutein , p = 0.012 ; lycopene , p = 0.016 ) , as did the activities of PON-1 and LCAT in HDL3 ( p = 0.006 and 0.044 , respectively ) .
CONCLUSIONS	To our knowledge , this is the first study in subjects with T2D to demonstrate that increased F&V intake augmented the carotenoid content and influenced enzymes associated with the antioxidant properties of HDL .
CONCLUSIONS	We suggest that these changes would enhance the cardioprotective properties of this lipoprotein .
BACKGROUND	ISRCTN21676269 .

###25404192
BACKGROUND	Premature cardiovascular disease limits the duration and quality of life on long-term hemodialysis .
BACKGROUND	The objective of this study was to define the frequency of fatal and nonfatal cardiovascular events attributable to atherosclerotic and nonatherosclerotic mechanisms , risk factors for these events , and the effects of cinacalcet , using adjudicated data collected during the EValuation of Cinacalcet HCl Therapy to Lower CardioVascular Events ( EVOLVE ) Trial .
RESULTS	EVOLVE was a randomized , double-blind , placebo-controlled clinical trial that randomized 3883 hemodialysis patients with moderate to severe secondary hyperparathyroidism to cinacalcet or matched placebo for up to 64 months .
RESULTS	For this post hoc analysis , the outcome measure was fatal and nonfatal cardiovascular events reflecting atherosclerotic and nonatherosclerotic cardiovascular diseases .
RESULTS	During the trial , 1518 patients experienced an adjudicated cardiovascular event , including 958 attributable to nonatherosclerotic disease .
RESULTS	Of 1421 deaths during the trial , 768 ( 54 % ) were due to cardiovascular disease .
RESULTS	Sudden death was the most frequent fatal cardiovascular event , accounting for 24.5 % of overall mortality .
RESULTS	Combining fatal and nonfatal cardiovascular events , randomization to cinacalcet reduced the rates of sudden death and heart failure .
RESULTS	Patients randomized to cinacalcet experienced fewer nonatherosclerotic cardiovascular events ( adjusted relative hazard 0.84 , 95 % CI 0.74 to 0.96 ) , while the effect of cinacalcet on atherosclerotic events did not reach statistical significance .
CONCLUSIONS	Accepting the limitations of post hoc analysis , any benefits of cinacalcet on cardiovascular disease in the context of hemodialysis may result from attenuation of nonatherosclerotic processes .
BACKGROUND	Unique identifier : NCT00345839 .
BACKGROUND	URL : ClinicalTrials.gov .

###25377986
OBJECTIVE	The aims of this study were to compare radiofrequency tissue reduction ( RFTR ) and electrocautery ( EC ) techniques by assessing preoperatively and 8 weeks postoperatively the visual analog scale ( VAS ) , inspiratory peak flowmetry ( IPF ) , and magnetic resonance imaging ( MRI ) volume measurement of the inferior turbinate and to see whether EC still stands as a valid treatment of inferior turbinate hypertrophy .
METHODS	A total of 36 patients were included in the study .
METHODS	An equal number of patients were chosen randomly from 2 groups .
METHODS	Inferior turbinate volumes measured by MRI , IPF , the VAS , and the Sinonasal Outcome Test-20 were used to determine the efficacy of treatment and to compare the 2 groups .
RESULTS	Postoperative IPF increase , VAS score decrease , and Sinonasal Outcome Test-20 score decrease were statistically more significant in the EC group , compared with the RFTR group .
RESULTS	Although statistically not significant , postoperative inferior turbinate MRI volume decrease was more evident in the EC group when compared with the RFTR group .
CONCLUSIONS	Both RFTR and EC techniques could be used as an effective treatment of choice for inferior turbinate hypertrophy , and EC technique is superior to RFTR technique to achieve high efficiency .

###24970846
BACKGROUND	Immunization of healthy volunteers during receipt of chemoprophylaxis with Plasmodium falciparum sporozoites ( CPS-immunization ) induces sterile protection from malaria .
BACKGROUND	Antibody responses have long been known to contribute to naturally acquired immunity against malaria , but their association with sterile protection after whole sporozoite immunization is not well established .
BACKGROUND	We therefore studied the induction and kinetics of malaria parasite antigen-specific antibodies and memory B-cells ( MBCs ) during CPS-immunization and their correlation with protection from challenge infection .
METHODS	We assessed humoral reactivity to 9 antigens representing different stages of the life cycle of P. falciparum by performing standardized MBC enzyme-linked immunospot and enzyme-linked immunosorbent assays on peripheral blood mononuclear cells and plasma samples from 38 Dutch volunteers enrolled in 2 randomized controlled clinical trials .
RESULTS	MBCs and antibodies recognizing pre-erythrocytic and cross-stage antigens were gradually acquired during CPS-immunization .
RESULTS	The magnitude of these humoral responses did not correlate with protection but directly reflected parasite exposure in CPS-immunization and challenge .
CONCLUSIONS	Humoral responses to the malarial antigens circumsporozoite protein , liver-stage antigen-1 , apical membrane antigen-1 , and merozoite surface protein-1 do not to predict protection from challenge infection but can be used as sensitive marker of recent parasite exposure .
BACKGROUND	NCT01236612 and NCT01218893 .

###25181938
OBJECTIVE	To examine effects of music therapy and progressive muscle relaxation training on depression , anxiety and length of hospital stay in Chinese female breast cancer patients after radical mastectomy .
METHODS	A total of 170 patients were randomly allocated to the intervention group ( n = 85 ) receiving music therapy and progressive muscle relaxation training plus routine nursing care and the control group ( n = 85 ) receiving routine nursing care .
METHODS	Music therapy and progressive muscle relaxation training were performed twice a day within 48 h after radical mastectomy , once in the early morning ( 6a.m.-8a .
METHODS	m. ) and once in the evening ( 9p.m.-11p .
METHODS	m. ) , for 30 min per session until discharged from the hospital .
RESULTS	A general linear model with univariate analysis showed that the intervention group patients had significant improvement in depression and anxiety in the effects of group ( F = 20.31 , P < 0.001 ; F = 5.41 , P = 0.017 ) , time ( F = 56.64 , P < 0.001 ; F = 155.17 , P < 0.001 ) and group * time interaction ( F = 6.91 , P = 0.009 ; F = 5.56 , P = 0.019 ) .
RESULTS	The intervention group patients had shorter length of hospital stay ( 12.56 1.03 ) than that of the control group ( 17.01 2.46 ) with statistical significance ( F = 13.36 , P < 0.001 ) .
CONCLUSIONS	Music therapy and progressive muscle relaxation training can reduce depression , anxiety and length of hospital stay in female breast cancer patients after radical mastectomy .

###26427107
OBJECTIVE	To investigate the effectiveness of Shoushen granule , Chinese herbal preparation , on carotid artery elasticity in patients with carotid atherosclerosis .
METHODS	The total of 156 carotid atherosclerosis patients were randomly divided into the intervention group ( 83 cases , treated with Shoushen granule ) and the control group ( 73 cases , treated with pravastatin ) .
METHODS	Brachial-ankle pulse wave velocity baPWV ) and Ankle-Brachial Pressure Index ( ABI ) were measured by automated arteriosclerosis detector .
METHODS	The changes of common carotid artery intima-media thickness ( IMT ) and parameters of the carotid artery elasticity in patients , including stiffness parameter ( ) , pressure-strain elastic modulus ( Ep ) , arterial compliance ( Ac ) , augmentation index ( AI ) , and pulse wave velocity ( PWV ) were detected by Echo-Tracking ( ET ) technique before and after 24 week treatment .
METHODS	In the meantime , levels of blood lipid , and liver and renal function were measured respectively .
RESULTS	After 24 weeks , baPWV , MT and parameters of the carotid artery elasticity ( , Ep , AI and PWV ) were markedly decreased in intervention group compared with those of before treatment ( P < 0.01 ) , but the level of Ac was increased significantly ( P < 0.01 ) .
RESULTS	And there were no significant differences compared with control group on the same period ( P > 0.05 ) .
CONCLUSIONS	In this pilot study , it was demonstrated ET technology and automated arteriosclerosis detector could be used to evaluate carotid artery elasticity effectively , and the action of Shoushen granule on carotid atherosclerosis might be related to the regulation of carotid artery elasticity .

###24350695
OBJECTIVE	To determine the effect of nonlinear frequency compression ( NLFC ) on children 's development of speech and language at three years of age .
METHODS	A randomized controlled trial was conducted as part of the population-based longitudinal study on outcomes of children with hearing impairment ( LOCHI ) .
METHODS	Participants were randomly assigned to fitting with NLFC ( Phonak Naida V SP or UP ) or with conventional processing in hearing aids , prescribed by using either the NAL or the DSL formula .
METHODS	Standardized tests of speech production , receptive and expressive language were administered , and parent ratings were collected .
METHODS	All assessments were double-blinded .
METHODS	Participants were 44 of the 450 children in the LOCHI cohort .
RESULTS	Compared to children using conventional processing , receptive and expressive language was higher but receptive vocabulary and consonant articulation scores were lower for children who use NLFC .
RESULTS	There was increased substitution of affricates by fricatives for children using NLFC , compared to children using conventional amplification .
RESULTS	After allowing for the effect of multiple demographic variables , the difference in global language scores between groups was not significant ( effect : 0.8 [ 95 % confidence interval : - 6.7 , 8.3 ] ) .
CONCLUSIONS	There is insufficient evidence to indicate a difference in language ability between children using NLFC and those using conventional amplification .

###24883319
OBJECTIVE	A prospective , randomized , controlled , double-blind clinical trial to assess the effect of tramadol and ketamine , 50 mg , added to ropivacaine in brachial plexus anesthesia .
METHODS	Thirty-six ASA physical statuses I and II patients , between 18 and 60 years of age , scheduled for forearm and hand surgery under axillary brachial plexus block , were allocated to 3 groups .
METHODS	Group R received 0.375 % ropivacaine in 40 mL , group RT received 0.375 % ropivacaine in 40 mL with 50 mg tramadol , and group RK received 0.375 % ropivacaine in 40 mL with 50 mg ketamine for axillary brachial plexus block .
METHODS	The onset times and the duration of sensory and motor blocks , duration of analgesia , hemodynamic parameters , and adverse events ( nausea , vomiting , and feeling uncomfortable ) were recorded .
RESULTS	The onset time of sensorial block was the fastest in ropivacaine + tramadol group .
RESULTS	Duration of sensorial and motor block was the shortest in the ropivacaine + tramadol group .
RESULTS	Duration of analgesia was significantly longer in ropivacaine + tramadol group .
CONCLUSIONS	We conclude that when added to brachial plexus analgesia at a dose of 50 mg , tramadol extends the onset and duration time of the block and improves the quality of postoperative analgesia without any side effects .

###24356481
OBJECTIVE	The objective of this study was to assess the effect of golimumab on carotid ultrasound measures and cardiovascular serious adverse events ( SAEs ) in patients with inflammatory arthritides .
METHODS	An exploratory carotid artery ultrasound substudy was performed in the GO-BEFORE study of methotrexate ( MTX ) - naive rheumatoid arthritis patients , with ultrasounds performed at weeks 0 , 24 , and 52 to measure common carotid artery intima-media thickness , distensibility coefficient , interadventitial diameter , and plaque count .
METHODS	Cardiovascular SAEs reported over 2 years of follow-up were assessed in 5 golimumab phase 3 clinical trials of patients with rheumatoid arthritis ( GO-BEFORE , GO-FORWARD , and GO-AFTER ) , psoriatic arthritis ( GO-REVEAL ) , and ankylosing spondylitis ( GO-RAISE ) .
METHODS	In GO-BEFORE and GO-FORWARD , patients received placebo + MTX , golimumab 50 mg + MTX , or golimumab 100 mg + / - MTX at baseline and every 4 weeks ; in the other 3 trials , patients received placebo or golimumab 50 or 100 mg .
RESULTS	The carotid ultrasound substudy showed inconsistent changes in common carotid artery intima-media thickness in the golimumab + MTX groups over time , and there was large variability in the measurements .
RESULTS	Increases in interadventitial diameter were observed in the golimumab 100 mg + placebo group , but not in the golimumab + MTX groups .
RESULTS	There were no significant differences in the distensibility coefficient and plaque count between the golimumab and placebo groups .
RESULTS	Very few patients overall experienced a cardiovascular SAE , and the incidence of cardiovascular SAEs was not statistically different between the golimumab and placebo groups .
CONCLUSIONS	The results of the carotid ultrasound substudy were inconclusive , and no increase or decrease in cardiovascular SAEs was observed following 2 years of treatment with golimumab with or without MTX .

###24301237
BACKGROUND	Although botulinum toxin type A ( BoNT-A ) has been used effectively and safely to reduce facial dynamic wrinkles , few studies assessed patients ' quality of life and satisfaction after treatment .
OBJECTIVE	To assess the quality of life and satisfaction of patients treated with full-face injections of variable doses of abobotulinum toxin A ( ABO ) .
METHODS	Ninety subjects were randomized into 3 different groups , receiving 120-165 U , 166-205 U and 206-250 U , respectively .
METHODS	WHOQOL - BREF and Satisfaction and Self-assessment Questionnaire ( SSQ ) were completed by subjects up to 6 months after treatment .
RESULTS	Most of the subjects were women ( 96.5 % ) .
RESULTS	For the physical domain in WHOQOL , a difference was observed between baseline and visit 2 ( p = 0.036 ) .
RESULTS	There was no difference between groups for mean grades regarding amount of wrinkles , beauty , harmony and symmetry .
RESULTS	However , there was a significant difference in the mean grades between visits .
RESULTS	Patients ' opinions also showed an improvement in their self-image up to four months after treatment , according to the self-grading .
CONCLUSIONS	The results presented in this study show improvements in patients ' quality of life during the peak of action of BoNT-A treatment , regarding the physical aspect .
CONCLUSIONS	In addition , patients reported good satisfaction after a full-face approach .

###24766763
OBJECTIVE	This study extends previous research on masculinity and negative drinking consequences among young men by considering mediating effects of heavy episodic drinking ( HED ) and alcohol expectancies .
OBJECTIVE	We hypothesized that masculinity would have a direct relationship with negative consequences from drinking as well as indirect relationships mediated by HED and alcohol expectancies of courage , risk , and aggression .
METHODS	A random sample of 1,436 college and university men ages 19-25 years completed an online survey , including conformity to masculine norms , alcohol-related expectancies , HED , and negative drinking consequences .
METHODS	Regression analyses and structural equation modeling were used .
RESULTS	Six of seven dimensions of masculinity and the alcohol expectancy scales were significantly associated with both HED and negative consequences .
RESULTS	In multivariate regression models predicting HED and negative consequences , the playboy and violence dimensions of masculinity and the risk/aggression alcohol expectancy remained significant .
RESULTS	HED and the risk-taking dimension of masculinity were also significant in the model predicting negative consequences .
RESULTS	The structural equation model indicated that masculinity was directly associated with HED and negative consequences but also influenced negative consequences indirectly through HED and alcohol expectancies .
CONCLUSIONS	The findings suggest that , among young adult male college and university students , masculinity is an important factor related to both HED and drinking consequences , with the latter effect partly mediated by HED and alcohol expectancies .
CONCLUSIONS	Addressing male norms about masculinity may help to reduce HED and negative consequences from drinking .

###24683783
OBJECTIVE	To evaluate the acceptance of midazolam spray through buccal route as compared to intranasal route and compare the efficacy of the drug through both the routes .
METHODS	30 patients aged 2-8 years with Grade I or II Frankl 's Behaviour Rating Scale were selected who required similar treatment under local anesthesia on two teeth .
METHODS	Midazolam spray was administered randomly through buccal or intranasal routes for the two appointments .
METHODS	Scoring was done for the acceptance of drug and Houpt 's score was recorded for the behaviour of patients during the treatment .
RESULTS	Acceptance of drug through buccal route was significantly better than the intranasal route ( p < 0.05 ) but no statistically significant difference was found in the behaviour scores for the two routes of administration ( p > 0.05 ) .
CONCLUSIONS	Midazolam spray can be effectively used through the buccal mucosa in children who give poor compliance with the intranasal administration .

###24365208
OBJECTIVE	To compare the efficacy and adverse effects of ergometrine and oxytocin given intramuscularly for the prevention of postpartum hemorrhage during the third stage of labor .
METHODS	The study included women with a singleton pregnancy of at least 28 weeks ' gestation who had a vaginal delivery .
METHODS	High-risk pregnancies were excluded .
METHODS	Oxytocin ( 10 IU ) or ergometrine ( 0.5 mg ) were administered intramuscularly in a blinded pattern immediately after delivery of the infant .
METHODS	An intention-to-treat analysis was performed .
RESULTS	Postpartum blood loss ( 301.8 109.2 mL versus 287.1 84.4 mL , P = 0.011 ) and packed cell volume ( 30.7 1.7 % versus 31.6 2.0 % ; Z = 0.00 ; P = 0.008 ) were considerably reduced among parturients who received intramuscular ergometrine .
RESULTS	The rates of therapeutic oxytocics use , blood transfusion , placental retention , and manual removal of the placenta were significantly higher in the oxytocin group .
RESULTS	No significant differences between the groups were observed in terms of adverse effects , with the exception of diastolic hypertension , which was more common in the ergometrine group ( odds ratio , 0.00 ; 95 % confidence interval , 0.00-0 .75 ; P = 0.007 ) .
CONCLUSIONS	Intramuscular ergometrine is superior to intramuscular oxytocin in averting postpartum hemorrhage during the third stage of labor .
CONCLUSIONS	There are no significant risks of adverse effects except for diastolic hypertension .

###24530171
OBJECTIVE	We aim to report the `` deep tiny flow voids '' ( DTFV ) , a unique HR-MRI finding suggestive of deep collateral vessels along middle cerebral artery ( MCA ) occlusions .
METHODS	We retrospectively reviewed the HR-MRI data of 60 patients with unilateral MCA occlusion ( 32 symptomatic and 28 asymptomatic ) and 205 control subjects with normal MCA on magnetic resonance angiography .
METHODS	The presence or absence of DTFV , defined as three or more flow voids along the occluded MCA on at least two consecutive T2-weighted image slices , was observed .
METHODS	The relationships among DTFV , clinical presentations , and infarct sizes were analyzed .
RESULTS	DTFV were identified in 20/28 ( 71 % ) patients with asymptomatic MCA occlusions , much more frequently than in the patients with symptomatic occlusions ( 5/32 , 16 % ) ( P < 0.001 ) .
RESULTS	There were 9 patients with a large territorial infarction ( 1/3 MCA distribution ) , none of whom had DTFV on HR-MRI .
RESULTS	DTFV was not observed in any control subject .
CONCLUSIONS	DTFV are pathological conditions and associated with relatively good imaging outcomes and asymptomatic MCA occlusions .
CONCLUSIONS	The function and clinical implications of DTFV warrant further investigations .

###25414157
OBJECTIVE	Little is known about the optimal duration of antibiotic therapy for diabetic foot osteomyelitis ( DFO ) .
OBJECTIVE	This study sought to compare the effectiveness of 6 versus 12 weeks of antibiotic therapy in patients with DFO treated nonsurgically ( i.e. , antibiotics alone ) .
METHODS	This was a prospective randomized trial comparing 6 - versus 12-week duration of antibiotic treatment .
METHODS	Remission of osteomyelitis during the monitoring period was defined as complete and persistent ( > 4 weeks ) healing of the wound ( if present initially ) , absence of recurrent infection at the initial site or that of adjacent rays , and no need for surgical bone resection or amputation at the end of a follow-up period of at least 12 months after completion of antibiotic treatment .
RESULTS	Forty patients followed at five French general hospitals were randomized between January 2007 and January 2009 , with 20 treated for 6 weeks and 20 treated for 12 weeks with antibiotics .
RESULTS	The two groups were comparable for all variables recorded at inclusion in the study .
RESULTS	Remission was obtained in 26 ( 65 % ) patients , with no significant differences between patients treated for 6 versus 12 weeks ( 12/20 vs. 14/20 , respectively ; P = 0.50 ) .
RESULTS	We did not identify any significant parameters associated with patient outcome .
RESULTS	Fewer patients treated for 6 weeks experienced gastrointestinal adverse events related to antimicrobial therapy compared with patients treated for 12 weeks ( respectively , 15 vs. 45 % ; P = 0.04 ) .
CONCLUSIONS	The present multicenter prospective randomized study provides data suggesting that 6-week duration of antibiotic therapy may be sufficient in patients with DFO for whom nonsurgical treatment is considered .

###24628923
OBJECTIVE	OnabotulinumtoxinA was effective and well tolerated for prophylaxis of headache in patients with chronic migraine ( CM ) in two randomized , double-blind , placebo-controlled , phase 3 trials .
OBJECTIVE	To further assess the safety and tolerability of onabotulinumtoxinA in CM prophylaxis in adults , the pooled safety data from four double-blind , placebo-controlled trials were analyzed .
METHODS	The pooled analysis included two phase 2 and two phase 3 double-blind , placebo-controlled trials .
METHODS	The safety population was 2436 patients , 1997 of whom received 1 dose of onabotulinumtoxinA .
METHODS	The studies shared similar dosing intervals ( approximately 12weeks ) with doses between 75 and 260U .
METHODS	Safety assessments included adverse events ( AEs ) , physical examination and clinical laboratory tests .
RESULTS	OnabotulinumtoxinA was safe and well tolerated , with a low discontinuation rate ( 3.4 % ) due to AEs .
RESULTS	The majority of patients in this pooled analysis received doses between 150 and 200U , with an average of 163U per treatment cycle .
RESULTS	Of the 1997 patients who received any onabotulinumtoxinA injections , 1455 patients ( 72.9 % ) reported at least one AE .
RESULTS	Neck pain ( 12.6 % ) was the most common onabotulinumtoxinA-associated AE , followed by muscle weakness ( 8.0 % ) , musculoskeletal stiffness ( 6.1 % ) and eyelid ptosis ( 4.6 % ) .
RESULTS	Serious AEs were infrequent , occurring in 5.4 % of patients who received any onabotulinumtoxinA treatment and 3.0 % of patients receiving placebo .
RESULTS	AEs were consistent with the known tolerability profile of onabotulinumtoxinA .
CONCLUSIONS	Multiple treatments with onabotulinumtoxinA at doses of 75-260U administered every 12weeks , and up to five treatment cycles , were well tolerated for the prophylaxis of headache in adults with CM .

###25439595
OBJECTIVE	To assess the effects of intravitreal ranibizumab on diabetic retinopathy ( DR ) severity when administered for up to 3 years , evaluate the effect of delayed initiation of ranibizumab therapy on DR severity , and identify baseline patient characteristics associated with the development of proliferative DR ( PDR ) .
METHODS	Exploratory analyses of phase III , randomized , double-masked , sham-controlled multicenter clinical trials .
METHODS	Adults with diabetic macular edema ( DME ) ( N = 759 ) , baseline best-corrected visual acuity 20/40 to 20/320 Snellen equivalent , and central foveal thickness 275 m.
METHODS	Patients were randomized to monthly 0.3 or 0.5 mg ranibizumab or sham injections .
METHODS	Sham participants could switch to 0.5 mg ranibizumab during the third year ( sham/0 .5 mg crossover ) .
METHODS	Baseline risk factors were evaluated to explore potential associations with development of PDR .
METHODS	Time to first development of PDR was analyzed by Kaplan-Meier methods to calculate cumulative probabilities by group .
METHODS	Study eye change on the Early Treatment Diabetic Retinopathy Study severity scale and a composite clinical outcome evaluating progression to PDR based on photographic changes plus clinically important events defining PDR .
RESULTS	At month 36 , a greater proportion of ranibizumab-treated eyes had 2 - or 3-step DR improvement compared with sham/0 .5 mg crossover .
RESULTS	A 3-step improvement was achieved at 36 months by 3.3 % , 15.0 % , and 13.2 % of sham/0 .5 mg , 0.3 mg , and 0.5 mg ranibizumab-treated eyes , respectively ( P < 0.0001 ) .
RESULTS	Through 36 months , 39.1 % of eyes in the sham/0 .5 mg group developed PDR , as measured by composite outcome , compared with 18.3 % and 17.1 % of eyes treated with 0.3 or 0.5 mg ranibizumab , respectively .
RESULTS	The presence of macular capillary nonperfusion at baseline seems to be associated with progression to PDR in ranibizumab-treated eyes but did not meaningfully influence visual acuity improvement in eyes with DME after ranibizumab therapy .
CONCLUSIONS	Ranibizumab , as administered to patients with DME for 12 to 36 months in these studies , can both improve DR severity and prevent worsening .
CONCLUSIONS	Prolonged delays in initiation of ranibizumab therapy may limit this therapeutic effect .
CONCLUSIONS	Although uncommon , the development of PDR still occurs in a small percentage of eyes undergoing anti-vascular endothelial growth factor therapy and may be related to the presence of macular nonperfusion .

###24278924
OBJECTIVE	This study sought to prospectively evaluate changes in marginal bone levels and soft tissue dimensions around platform-switched , Morse taper-connection implants placed with the implant-abutment interface ( IAI ) at different positions in relation to the alveolar crest .
METHODS	Thirty patients in need of single-tooth rehabilitations were randomly assigned to three groups based on the position of the IAI in relation to the alveolar crest at the time of implant placement .
METHODS	Implants in groups 0 , 1 , and 2 ( n = 10 in each group ) were placed at the bone level or 1 mm and 2 mm below the buccal aspect of the alveolar crest , respectively .
METHODS	Four months later , the implants were restored with crowns .
METHODS	Clinical parameters were recorded at 4 and 12 months , and marginal bone levels were assessed radiographically at placement , 4 months , and 12 months .
RESULTS	Mean marginal bone loss below the implant platform in group 0 implants was 0.18 0.27 mm at 4 months and 0.27 0.45 mm at 12 months .
RESULTS	All implants in groups 1 and 2 exhibited no marginal bone loss below the implant platform , since the first bone-to-implant contact was located at or above the implant margin .
RESULTS	At 12 months , implants in groups 1 and 2 exhibited greater mean bone loss above the implant platform compared to implants in group 0 , but the differences were not statistically significant ( group 0 , 0.64 0.49 mm ; group 1 , 0.81 0.31 mm ; group 2 , 1.20 0.68 mm ) .
RESULTS	Implants in groups 1 and 2 exhibited a statistically significantly higher percentage of implant surfaces with bone on the implant platform compared to group 0 implants ( 90 % versus 35 % ) .
CONCLUSIONS	In the present study , differences in peri-implant bone responses existed for implants placed with the IAI at different locations in relation to the alveolar crest .

###24963007
BACKGROUND	In Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy ( MADIT-CRT ) , patients with non-left bundle branch block ( LBBB ; including right bundle branch block , intraventricular conduction delay ) did not have clinical benefit from cardiac resynchronization therapy with defibrillator ( CRT-D ) .
BACKGROUND	We hypothesized that baseline PR interval modulates clinical response to CRT-D therapy in patients with non-LBBB .
RESULTS	Non-LBBB patients ( n = 537 ; 30 % ) were divided into 2 groups based on their baseline PR interval as normal ( including minimally prolonged ) PR ( PR < 230 ms ) and prolonged PR ( PR 230 ms ) .
RESULTS	The primary end point was heart failure or death .
RESULTS	Separate secondary end points included heart failure events and all-cause mortality .
RESULTS	Cox proportional hazards regression models were used to compare risk of end point events by CRT-D to implantable cardioverter defibrillator therapy in the PR subgroups .
RESULTS	There were 96 patients ( 22 % ) with a prolonged PR and 438 patients ( 78 % ) with a normal PR interval .
RESULTS	In non-LBBB patients with a prolonged PR interval , CRT-D treatment was associated with a 73 % reduction in the risk of heart failure/death ( hazard ratio , 0.27 ; 95 % confidence interval , 0.13-0 .57 ; P < 0.001 ) and 81 % decrease in the risk of all-cause mortality ( hazard ratio , 0.19 ; 95 % confidence interval , 0.13-0 .57 ; P < 0.001 ) compared with implantable cardioverter defibrillator therapy .
RESULTS	In non-LBBB patients with normal PR , CRT-D therapy was associated with a trend toward an increased risk of heart failure/death ( hazard ratio , 1.45 ; 95 % confidence interval , 0.96-2 .19 ; P = 0.078 ; interaction P < 0.001 ) and a more than 2-fold higher mortality ( hazard ratio , 2.14 ; 95 % confidence interval , 1.12-4 .09 ; P = 0.022 ; interaction P < 0.001 ) compared with implantable cardioverter defibrillator therapy .
CONCLUSIONS	The data support the use of CRT-D in MADIT-CRT non-LBBB patients with a prolonged PR interval .
CONCLUSIONS	In non-LBBB patients with a normal PR interval , implantation of a CRT-D may be deleterious .
BACKGROUND	http://clinicaltrials.gov; Unique Identifier : NCT00180271 .

###24267731
BACKGROUND	Diabetic patients treated with metformin have a lower risk of developing BC or a better BC prognosis .
BACKGROUND	Metformin might reduce cancer growth through direct antiproliferative effects or through indirect mechanisms , particularly the reduction of insulin .
BACKGROUND	In a randomized study on nondiabetic BC patients in natural menopause with hightestosterone levels , we observed a significant decrease in insulin and in testosterone levels with metformin 1500mg/d compared with 1000 mg/d .
BACKGROUND	We present the results of a new analysis of our study on the effect of metformin on the bioavailability of sex hormones .
METHODS	One hundred twenty-four eligible women were initiallyinvited to take metformin 500 mg/d for 3 months .
METHODS	The 108 women who completed the first 3 months continued the study using 1000 mg/d for 1 month .
METHODS	The women were then randomized into 2 groups , and , for the subsequent 5months , 1 group increased the dose to 1500 mg/d , and the other group continued with 1000 mg/d .
RESULTS	Ninety-six women completed the study , 43 receiving metformin 1500 mg/day , and 53 receiving 1000 mg/day .
RESULTS	The women receiving 1500 mg/d showed a greater and significant reduction of free testosterone ( -29 % ) and estradiol ( -38 % ) , a borderline significant reduction of estrone and insulin-like growth factor-1 , and a nonsignificant reduction of androstenedione .
RESULTS	They also showed a nonsignificant increase of dehydroepiandrosterone sulfate .
CONCLUSIONS	Metformin does not interfere with the production of dehydroepiandrosterone sulfate .
CONCLUSIONS	Besides , it decreases estradiol levels , basically through the reduction of testosterone .
CONCLUSIONS	These hormonal changes might have clinical relevance .

###24365207
BACKGROUND	Upper airway obstruction ( UAO ) is a major problem in unconscious subjects , making full face mask ventilation difficult .
BACKGROUND	The mechanism of UAO in unconscious subjects shares many similarities with that of obstructive sleep apnea ( OSA ) , especially the hypotonic upper airway seen during rapid eye movement sleep .
BACKGROUND	Continuous positive airway pressure ( CPAP ) via nasal mask is more effective at maintaining airway patency than a full face mask in patients with OSA .
BACKGROUND	We hypothesized that CPAP via nasal mask and ventilation ( nCPAP ) would be more effective than full face mask CPAP and ventilation ( FmCPAP ) for unconscious subjects , and we tested our hypothesis during induction of general anesthesia for elective surgery .
METHODS	In total , 73 adult subjects requiring general anesthesia were randomly assigned to one of four groups : nCPAP P0 , nCPAP P5 , FmCPAP P0 , and FmCPAP P5 , where P0 and P5 represent positive end-expiratory pressure ( PEEP ) 0 and 5 cm H2O applied prior to induction .
METHODS	After apnea , ventilation was initiated with pressure control ventilation at a peak inspiratory pressure over PEEP ( PIP/PEEP ) of 20/0 , then 20/5 , and finally 20/10 cm H2O , each applied for 1 min .
METHODS	At each pressure setting , expired tidal volume ( Vte ) was calculated by using a plethysmograph device .
RESULTS	The rate of effective tidal volume ( Vte > estimated anatomical dead space ) was higher ( 87.9 % vs. 21.9 % ; P < 0.01 ) and the median Vte was larger ( 6.9 vs. 0 mL/kg ; P < 0.01 ) with nCPAP than with FmCPAP .
RESULTS	Application of CPAP prior to induction of general anesthesia did not affect Vte in either approach ( nCPAP pre - vs. post - ; 7.9 vs. 5.8 mL/kg , P = 0.07 ) ( FmCPAP pre - vs. post - ; 0 vs. 0 mL/kg , P = 0.11 ) .
CONCLUSIONS	nCPAP produced more effective tidal volume than FmCPAP in unconscious subjects .
BACKGROUND	ClinicalTrials.gov identifier : NCT01524614 .

###24793963
BACKGROUND	Viral upper respiratory tract infections occur frequently among conscripts .
BACKGROUND	Probiotics have reduced viral infections in children attending day care .
BACKGROUND	Limited data are available on the effects of probiotics on the nasopharyngeal presence of respiratory viruses .
OBJECTIVE	To assess , whether probiotics could decrease nasopharyngeal occurrence of respiratory viruses in Finnish conscripts .
METHODS	In a randomized , double-blind , placebo-controlled 90 - and 150-day intervention study , 239 nasopharyngeal swab samples were collected from 192 symptomatic conscripts receiving daily chewable probiotic tablet containing Lactobacillus rhamnosus GG and Bifidobacterium animalis ssp .
METHODS	lactis BB-12 ( 46.9 % ) or control tablet ( 53.1 % ) on visits to a garrison 's health care center due to symptoms of infection .
METHODS	The presence of respiratory viruses was tested by PCR-methods , and viral findings were compared between the intervention groups .
RESULTS	184 ( 76.9 % ) nasopharyngeal samples were positive for at least one respiratory virus .
RESULTS	Picornaviruses were the most common viruses and were detected in 155 ( 84.2 % ) of samples .
RESULTS	Of these , 143 ( 92.3 % ) were rhinovirus-positive and 20 ( 12.9 % ) were enterovirus-positive .
RESULTS	The control group had 83 ( 64 % ) and the probiotic group 72 ( 66 % ) picornavirus infections ( p = 0.79 ) .
RESULTS	Monthly distribution of picornaviruses showed that there were less picornavirus findings after 3 months in the probiotic group than in the control group ( p = 0.0069 ) .
RESULTS	However , probiotics did not reduce picornavirus occurrence in other months .
CONCLUSIONS	Overall , probiotics did not reduce viral occurrence in symptomatic conscripts .
CONCLUSIONS	However , probiotics decreased the presence of picornaviruses after 3 months , which may imply that probiotics play a role against viruses causing common cold .
CONCLUSIONS	Further investigations are necessary to clarify the mechanisms involved in order to target specific probiotics on specific respiratory viruses .

###25161182
OBJECTIVE	Many hypertensive subjects travel to high altitudes , but little is known on ambulatory blood pressure ( ABP ) changes and antihypertensive drugs ' efficacy under acute and prolonged exposure to hypobaric hypoxia .
OBJECTIVE	In particular , the efficacy of angiotensin receptor blockers in this condition is unknown .
OBJECTIVE	This may be clinically relevant considering that renin-angiotensin system activity changes at altitude .
OBJECTIVE	The HIGHCARE-HIMALAYA study assessed changes in 24 h ABP under acute and prolonged exposure to increasing altitude and blood pressure-lowering efficacy and safety of an angiotensin receptor blockade in this setting .
RESULTS	Forty-seven healthy , normotensive lowlanders were randomized to telmisartan 80 mg or placebo in a double-blind , parallel group trial .
RESULTS	Conventional and Ambulatory BPs were measured at baseline and on treatment : after 8 weeks at sea level , and under acute exposure to 3400 and 5400 m altitude , the latter upon arrival and after 12 days ( Mt. Everest base camp ) .
RESULTS	Blood samples were collected for plasma catecholamines , renin , angiotensin , and aldosterone .
RESULTS	In both groups , exposure to increasing altitude was associated with : ( i ) significant progressive increases in conventional and 24 h blood pressure , persisting throughout the exposure to 5400 m ; ( ii ) increased plasma noradrenaline and suppressed renin-angiotensin-aldosterone system .
RESULTS	Telmisartan lowered 24 h ABP at the sea level and at 3400 m ( between-group difference 4.0 mmHg , 95 % CI : 2.2-9 .5 mmHg ) , but not at 5400 m.
CONCLUSIONS	Ambulatory blood pressure increases progressively with increasing altitude , remaining elevated after 3 weeks .
CONCLUSIONS	An angiotensin receptor blockade maintains blood pressure-lowering efficacy at 3400 m but not at 5400 m.

###24937976
OBJECTIVE	To determine the impact of recombinant luteinizing hormone ( rLH ) combined with vaginal progesterone ( P ) for luteal supplementation on in vitro fertilization ( IVF ) pregnancy outcomes in high-responder patients undergoing long gonadotropin-releasing hormone ( GnRH ) agonist cycles .
METHODS	A total of 47 patients undergoing IVF cycles with the serum estradiol levels of > or = 2,500 pg/mL on the day of human chorionic gonadotropin administration were included in this prospective randomized study .
METHODS	Patients were divided into 2 treatment groups : the control group ( n = 23 ) used luteal vaginal P , and the study group ( n = 24 ) received a combination of vaginal P and 75 IU rLH , 4 doses every 3 days , starting on the day of embryo transfer .
METHODS	The main outcome measure was the clinical pregnancy rate ( PR ) .
RESULTS	The study group had 11 pregnancies ( 45.8 % ) , while the control group had 6 ( 26.1 % ) .
RESULTS	There was no significant difference between the groups in clinical PRs ( p = 0.15 ) .
RESULTS	No differences were found with respect to the implantation rate , miscarriage rate , and multiple PR .
CONCLUSIONS	Our data show that luteal supplementation with rLH combined to vaginal P was not found to improve pregnancy outcomes in high responder patients undergoing long GnRH agonist IVF treatments .

###24569914
BACKGROUND	Based on the result of our previous study showing better overall survival ( OS ) at the lower dose ( 0.2 g ) of immunomodulator Z-100 than higher dose ( 40 g ) in patients with locally advanced cervical cancer who received radiotherapy , we conducted a placebo-controlled double-blind randomized trial .
METHODS	Patients of stages IIB-IVA squamous cell carcinoma of the uterine cervix were randomly assigned to receive Z-100 at 0.2 g ( Z ) or placebo ( P ) .
METHODS	The study agent was given subcutaneously twice a week during the radiotherapy , followed by maintenance therapy by administering once every 2 weeks until disease progression .
METHODS	Primary end point was OS , and secondary end points were recurrence-free survival , and toxicity .
RESULTS	A total of 249 patients were randomized .
RESULTS	Death events occurred extremely slower than expected , and Independent Data Monitoring Committee recommended to analyze the survival result prematurely .
RESULTS	The 5-year OS rate was 75.7 % [ 95 % confidence interval ( CI ) 66.4 % to 82.8 % ] for Arm Z and 65.8 % ( 95 % CI 56.2 % to 73.8 % ) for Arm P ( P = 0.07 ) ; hazard ratio was 0.65 ( 95 % CI 0.40-1 .04 ) .
RESULTS	Survival benefit in Arm Z was observed regardless of chemoradiation or radiation alone .
RESULTS	There was no trend in recurrence-free survival between the two arms .
RESULTS	Side-effects were not different between two arms .
CONCLUSIONS	Z-100 showed a trend of improvement on OS in locally advanced cervical cancer , although the statistical power was less than anticipated because survival rates were unexpectedly higher than expected for both arms .
CONCLUSIONS	Validation of potential survival benefit of immune modulation should be made .
BACKGROUND	umin.ac.jp / ctr Identifier : C000000221 .

###26152008
OBJECTIVE	To compare the efficacy and safety of two different second-generation ablation devices , Novasure impedance control system and microwave endometrial ablation ( MEA ) , in cases of abnormal uterine bleeding ( AUB ) .
METHODS	This is a randomized controlled trial that took place in a single Gynecological Department of a University Hospital .
METHODS	Sixty-six women with dysfunctional uterine bleeding ( DUB ) , unresponsive to medical treatment , were included in the trial .
METHODS	The ratio of women allocated to bipolar radio-frequency ablation or MEA was 1:1 .
METHODS	Follow-up assessments were carried out at three and 12 months post-ablation .
METHODS	The present main outcome measure was amenorrhea rates 12-months post-treatment .
RESULTS	The rate of amenorrhea at 12-months post-ablation was significantly higher in women treated by Novasure ( 25/33 ; 75.8 % ) as compared to those treated by MEA ( 8/33 ; 24.2 % ) ( rate difference : +51.5 % , 95 % CI : +27.8 to +67.7 ) .
CONCLUSIONS	In women with DUB , endometrial ablation with Novasure bipolar radiofrequency impedance-controlled system is associated with increased rates of amenorrhea at 12-months post-treatment as compared to the MEA method .

###25265495
OBJECTIVE	To determine the effects of different intra-abdominal pressure values on visceral pain following gynecologic laparoscopic surgery in the Trendelenburg position .
METHODS	This randomized , controlled prospective trial was conducted at a tertiary education hospital and included 150 patients who underwent gynecologic laparoscopy with different abdominal insufflation pressures .
METHODS	There were 54 patients in the 8 mmHg low pressure group ( LPG ) , 45 in the 12 mmHg standard pressure group ( SPG ) , and 51 in the 15 mmHg high pressure group ( HPG ) .
METHODS	We assessed mean age , body mass index ( BMI ) , duration of surgery , analgesic consumption , length of hospital stay , amount of CO2 expended and volume of hemorrhage .
METHODS	Visceral pain and referred visceral pain were assessed 6 , 12 , and 24 h postoperatively using a visual analog scale ( VAS ) .
RESULTS	There was no significant difference in age , BMI , analgesic consumption or length of hospital stay among groups .
RESULTS	The mean operative time and total CO2 expended during surgery were higher in the LPG compared with the SPG and HPG .
RESULTS	The mean intensity of postoperative pain assessed by the VAS score at 6 and 12 h was less in the LPG than in the SPG and HPG and was reduced significantly at 12 h. VAS scores at 24 h in the LPG and SPG were lower than in the HPG .
CONCLUSIONS	Pain is reduced by low insufflation pressure compared with standard and high insufflation pressure following gynecologic laparoscopic surgery in the Trendelenburg position .
CONCLUSIONS	However , low insufflation pressure may result in longer operation times and increased hemorrhage .

###25660356
BACKGROUND	The role of lipid-lowering treatments in renoprotection for patients with diabetes is debated .
BACKGROUND	We studied the renal effects of two statins in patients with diabetes who had proteinuria .
METHODS	PLANET I was a randomised , double-blind , parallel-group trial done in 147 research centres in Argentina , Brazil , Bulgaria , Canada , Denmark , France , Hungary , Italy , Mexico , Romania , and the USA .
METHODS	We enrolled patients with type 1 or type 2 diabetes aged 18 years or older with proteinuria ( urine protein : creatinine ratio [ UPCR ] 500-5000 mg/g ) and taking stable angiotensin-converting enzyme inhibitors , angiotensin receptor blockers , or both .
METHODS	We randomly assigned participants to atorvastatin 80 mg , rosuvastatin 10 mg , or rosuvastatin 40 mg for 52 weeks .
METHODS	The primary endpoint was change from baseline to week 52 of mean UPCR in each treatment group .
METHODS	The study is registered with ClinicalTrials.gov , number NCT00296374 .
RESULTS	We enrolled 353 patients : 118 were assigned to rosuvastatin 10 mg , 124 to rosuvastatin 40 mg , and 111 to atorvastatin 80 mg ; of these , 325 were included in the intention-to-treat population .
RESULTS	UPCR baseline : week 52 ratio was 087 ( 95 % CI 077-099 ; p = 0033 ) with atorvastatin 80 mg , 102 ( 088-118 ; p = 083 ) with rosuvastatin 10 mg , and 096 ( 083-111 ; p = 053 ) with rosuvastatin 40 mg .
RESULTS	In a post-hoc analysis to compare statins , we combined data from PLANET I with those from PLANET II ( a similar randomised parallel study of 237 patients with proteinuria but without diabetes ; registered with ClinicalTrials.gov , NCT00296400 ) .
RESULTS	In this analysis , atorvastatin 80 mg lowered UPCR significantly more than did rosuvastatin 10 mg ( -156 % , 95 % CI -283 to -05 ; p = 0043 ) and rosuvastatin 40 mg ( -182 % , -302 to -42 ; p = 0013 ) .
RESULTS	Adverse events occurred in 69 ( 60 % ) of 116 patients in the rosuvastatin 10 mg group versus 79 ( 64 % ) of 123 patients in the rosuvastatin 40 mg group versus 63 ( 57 % ) of 110 patients in the atorvastatin 80 mg group ; renal events occurred in nine ( 78 % ) versus 12 ( 98 % ) versus five ( 45 % ) .
CONCLUSIONS	Despite high-dose rosuvastatin lowering plasma lipid concentrations to a greater extent than did high-dose atorvastatin , atorvastatin seems to have more renoprotective effects for the studied chronic kidney disease population .
BACKGROUND	AstraZeneca .

###24671507
OBJECTIVE	To investigate the efficacy and safety of combining vandetanib , an orally available multi-targeted tyrosine kinase inhibitor of vascular endothelial growth factor receptor-2 ( VEGFR-2 ) and epidermal growth factor receptor ( EGFR ) , with bicalutamide in patients with metastatic castration-resistant prostate cancer ( mCRPC ) .
METHODS	This was an open-label , randomized phase II multi-center study .
METHODS	Eligible patients had rising PSA on androgen deprivation therapy , minimal symptoms and were chemotherapy-nave .
METHODS	Protocol therapy was either vandetanib 300 mg oral daily plus bicalutamide 50 mg oral daily ( Arm A ) or bicalutamide 50 mg oral daily alone ( Arm B ) with cross-over to vandetanib monotherapy at progression .
METHODS	The primary endpoint was PSA response ( 50 % decline from baseline ) .
RESULTS	Thirty-nine patients were recruited , 19 in Arm A and 20 in Arm B. PSA response was comparable in Arm A and Arm B ( 18 vs. 19 % ) .
RESULTS	Time to PSA progression was 3.16 months ( 95 % confidence interval ( CI ) : 1.09 , not reached ( NR ) ) for Arm A and 3.09 months ( 95 % CI : 1.22 , NR ) for Arm B. Treatment discontinuation due to adverse events was more common in Arm A compared to Arm B ( 42 vs. 5 % ; p = 0.019 ) .
RESULTS	Treatment with vandetanib was associated with a reduction in soluble VEGFR-2 levels after two cycles but an increase in plasma VEGF levels .
CONCLUSIONS	The combination of vandetanib and bicalutamide was associated with considerable toxicity and did not have superior efficacy over bicalutamide alone .
CONCLUSIONS	Further evaluation of this combination is not warranted in mCRPC .

###24987061
OBJECTIVE	FcR polymorphisms have been reported to enhance the immune-mediated effects of cetuximab in metastatic colorectal cancer .
OBJECTIVE	There are no data on the relationship between these polymorphisms and cetuximab in the early-stage setting .
OBJECTIVE	We performed a pharmacogenomic analysis of EXPERT-C , a randomized phase II trial of neoadjuvant CAPOX followed by chemoradiotherapy , surgery , and adjuvant CAPOXcetuximab in high-risk , locally advanced rectal cancer .
METHODS	FcRIIa-H131R and FcRIIIa-V158F polymorphisms were analyzed on DNA from peripheral blood samples .
METHODS	Kaplan-Meier method and Cox regression analysis were used to calculate survival estimates and compare treatment arms .
RESULTS	Genotyping was successfully performed in 105 of 164 ( 64 % ) patients ( CAPOX = 54 , CAPOX-C = 51 ) .
RESULTS	No deviation from the Hardy-Weinberg equilibrium or association of these polymorphisms with tumor RAS status was observed .
RESULTS	FcRIIa-131R ( HR , 0.38 ; P = 0.058 ) and FcRIIIa-158F alleles ( HR , 0.21 ; P = 0.007 ) predicted improved progression-free survival ( PFS ) in patients treated with cetuximab .
RESULTS	In the CAPOX-C arm , carriers of both 131R and 158F alleles had a statistically significant improvement in PFS ( 5 years : 78.4 % ; HR , 0.22 ; P = 0.002 ) and overall survival ( OS ; 5 years : 86.4 % ; HR , 0.24 ; P = 0.018 ) when compared with patients homozygous for 131H and/or 158V ( 5-year PFS : 35.7 % ; 5-year OS : 57.1 % ) .
RESULTS	An interaction between cetuximab benefit and 131R and 158F alleles was found for PFS ( P = 0.017 ) and remained significant after adjusting for prognostic variables ( P = 0.003 ) .
CONCLUSIONS	This is the first study investigating FcRIIa and FcRIIIa polymorphisms in patients with early-stage colorectal cancer treated with cetuximab .
CONCLUSIONS	We showed an increased clinical benefit from cetuximab in the presence of 131R and 158F alleles .

###24576788
BACKGROUND	Diabetic cardiomyopathy defined as either systolic or diastolic dysfunction in otherwise healthy diabetic persons is not clearly understood .
BACKGROUND	The prevalence and outcomes of this disease in a community-based population have not been defined .
RESULTS	Cross-sectional survey of 2042 randomly selected residents of Olmsted County , Minnesota , aged 45 years or older between June 1997 and September 2000 .
RESULTS	All patients underwent Doppler echocardiographic assessment of systolic and diastolic function .
RESULTS	Diabetic cardiomyopathy was defined in a person with diabetes and any systolic or at least moderate diastolic dysfunction without a history of coronary disease , hypertension , significant valvular disease , or congenital heart disease .
RESULTS	The diagnosis of diabetic cardiomyopathy was made in 23 people , corresponding to a community population prevalence rate of 1.1 % .
RESULTS	Among diabetic patients , 16.9 % met criteria for diabetic cardiomyopathy and 54.4 % had diastolic dysfunction .
RESULTS	Diabetes was associated with a 1.9-fold increase in risk of any left ventricular dysfunction , a 1.7-fold increase in risk of diastolic dysfunction , and a 2.2-fold increase in risk of systolic dysfunction .
RESULTS	Among patients with diabetic cardiomyopathy , the cumulative probability of death was 18 % , development of heart failure was 22 % , and development of death or heart failure was 31 % at 9 years .
CONCLUSIONS	Diabetic cardiomyopathy is relatively common in the community with a prevalence of 1.1 % .
CONCLUSIONS	The morbidity and mortality of patients with diabetic cardiomyopathy is high .

###24411489
OBJECTIVE	Protein source , macronutrient composition and content of long chain-polyunsaturated fatty acids ( LC-PUFA ) of infant formulae may influence infant growth .
OBJECTIVE	We aimed to assess the effect of a modified infant formula on growth .
METHODS	In a randomized , double-blind trial , 213 healthy term infants consumed isoenergetic study formulae ( intervention formula - IF , control formula - CF ) from the first month of life until the age of 120 days .
METHODS	IF ( 1.89 g protein/100 kcal ) contained - lactalbumin ( ALAB ) and LC-PUFA , while CF ( 2.30 g protein/100 kcal ) provided standard whey and no LC-PUFA .
METHODS	Anthropometry and dietary intake were regularly assessed .
METHODS	A venous blood sample was obtained on day 120 .
RESULTS	Both formulae were well-accepted without significant differences in health related observations .
RESULTS	Weight gain was not statistically different between formula groups ( IF : 30.2 6.3 vs. CF : 28.3 6.5 g/day , mean SD , P = 0.06 ) .
RESULTS	Length gain was higher in IF ( 0.11 0.02 vs. 0.10 0.02 cm/day , P = 0.02 ) .
RESULTS	Energy intake from formula was higher in CF at 90 and 120 days ( IF : 509 117 and 528 123 vs. CF : 569 152 and 617 169 kcal/day , P < 0.01 ) .
RESULTS	Protein intake in CF was significantly higher at each assessment .
RESULTS	Growth per energy intake was higher in IF compared to CF for weight ( 6.45 2.01 vs. 5.67 2.21 g/100 kcal , P = 0.02 ) and length ( 0.23 0.08 vs. 0.20 0.08 mm/100 kcal , P = 0.04 ) .
CONCLUSIONS	The modified infant formula with reduced protein content with added ALAB and LC-PUFA , meets infant requirements of protein for adequate growth .
CONCLUSIONS	The increased energetic efficiency of the new infant formula might result from improved protein composition by added ALAB .
CONCLUSIONS	Apparently minor differences in composition can markedly affect energetic efficiency for growth .
CONCLUSIONS	The study was registered at ClinicalTrials.gov ( NCT01094080 ) .

###24796970
OBJECTIVE	This study examines the effects of parental lisdexamfetamine ( LDX ) treatment on parent-child interactions .
METHODS	Participants were 30 parents ( 27 % were male ) and their children aged 5-12 years , both diagnosed with DSM-IV attention-deficit/hyperactivity disorder ( ADHD ) .
METHODS	Optimal LDX dose ( 30 , 50 , or 70 mg/day ) was determined for parents during a 3-week open-label titration , followed by a within-subjects trial of the acute impact of LDX and placebo on observable parent-child interactions .
METHODS	Two laboratory-based , parent-child interactions simulating typical family tasks ( e.g. , homework , joint play ) were conducted within 2 weeks , once with the adult on a blinded optimal dose of LDX and once on placebo ( phase I ) .
METHODS	Parents were then randomly assigned to continue blinded treatment with LDX or placebo for another month followed by a third interaction task ( phase II ) to assess the ongoing effects of LDX on parent-child interactions .
METHODS	The primary outcome was the change in rate of parenting behaviors coded during the parent-child interaction tasks .
METHODS	Secondary outcomes included observed rates of children 's inappropriate behaviors during the laboratory tasks and changes in parental ADHD symptom severity ( ADHD-Rating Scale ) .
RESULTS	Twenty parents ( 67 % ) completed the trial .
RESULTS	In phase I , medication was associated with a significant reduction in negative talk by parents ( p = 0.0066 , d = -0.47 ) .
RESULTS	There was a Medication Task interaction ( p = 0.0235 ) with a reduction in children 's negative behaviors in the homework phase only ( p = 0.0154 , d = -0.58 ) .
RESULTS	In phase II , LDX was associated with significant increases in praise by parents ( d = 0.81 ) and reductions in parental commands ( d = -0.88 ) and children 's inappropriate behaviors ( d = -0.84 ) ( all p-values < 0.05 ) .
RESULTS	While not reaching statistical significance , LDX was also associated with large reductions in parental verbalizations ( d = -0.82 ) , moderate increases in parental responsiveness ( d = 0.55 ) , and large reductions in the ratio of commands to verbalizations during the non-homework task ( d = -1.05 ) ( all p-values < 0.10 ) .
RESULTS	Significant reductions in parental ADHD symptoms vs. placebo were observed ( p < 0.005 ) .
RESULTS	Loss of appetite , dry mouth , headaches , and delayed sleep onset were the most common adverse events .
CONCLUSIONS	Improvements in parent-child interactions emerged over time with LDX treatment of parental ADHD .
CONCLUSIONS	Results suggest that pharmacological treatment of parental ADHD may improve outcomes in parents and their children .

###24494468
OBJECTIVE	The aim of this study was to investigate the effects of a restrictive vs. a liberal postoperative fluid therapy guided by intrathoracic blood volume index ( ITBVI ) on hemodynamic and pulmonary function in patients undergoing elective esophagectomy .
OBJECTIVE	Perioperative fluid therapy may influence postoperative physiology and morbidity after esophageal surgery .
OBJECTIVE	Definitions of adequate infusion amounts and evident rules for a fluid therapy are missing .
METHODS	After esophagectomy , 22 patients were randomized either to a restrictive group ( RG ) with low range of ITBVI ( 600-800 ml/m2 ) or a liberal group ( LG ) with normal ITBVI ( 800-1000 ml/m2 ) .
METHODS	Infusion regimen was modified twice a day according to transpulmonary thermodilution measurements until the 5th postoperative day .
METHODS	Primary endpoint was paO2/FIO2-ratio .
METHODS	Secondary endpoints were pulmonary function , fluid balance and hemodynamic as well as morbidity .
RESULTS	Demographic and surgical details did not differ between both groups .
RESULTS	The calculated sample size was not reached .
RESULTS	There were no postoperative differences in paO2/FIO2-ratio , ITBVI , hemodynamic parameters , or morbidity either .
RESULTS	Cumulative fluid uptake was 4.1 liter less in the RG on the 5th postoperative day ( p = 0.01 ) , and pulmonary function was better in these patients ( area under curve day 2-7 for forced vital capacity ( FVC ) , forced expiratory volume in one second ( FEV1 ) , peak expiratory flow ( PEF ) each < 0.05 ) .
CONCLUSIONS	ITBVI guided restrictive infusion therapy yields a lower fluid uptake , but may not result in a difference of clinical relevant parameters .
CONCLUSIONS	A fluid restriction after esophagectomy should always be combined with hemodynamic monitoring because additional infusions may be required .

###25458644
BACKGROUND	Recurrent vascular events remain a major source of morbidity and mortality after stroke or transient ischemic attack ( TIA ) .
BACKGROUND	The IRIS Trial is evaluating an approach to secondary prevention based on the established association between insulin resistance and increased risk for ischemic vascular events .
BACKGROUND	Specifically , IRIS will test the effectiveness of pioglitazone , an insulin-sensitizing drug of the thiazolidinedione class , for reducing the risk for stroke and myocardial infarction ( MI ) among insulin resistant , nondiabetic patients with a recent ischemic stroke or TIA .
METHODS	Eligible patients for IRIS must have had insulin resistance defined by a Homeostasis Model Assessment-Insulin Resistance > 3.0 without meeting criteria for diabetes .
METHODS	Within 6 months of the index stroke or TIA , patients were randomly assigned to pioglitazone ( titrated from 15 to 45 mg/d ) or matching placebo and followed for up to 5 years .
METHODS	The primary outcome is time to stroke or MI .
METHODS	Secondary outcomes include time to stroke alone , acute coronary syndrome , diabetes , cognitive decline , and all-cause mortality .
METHODS	Enrollment of 3,876 participants from 179 sites in 7 countries was completed in January 2013 .
METHODS	Participant follow-up will continue until July 2015 .
CONCLUSIONS	The IRIS Trial will determine whether treatment with pioglitazone improves cardiovascular outcomes of nondiabetic , insulin-resistant patients with stroke or TIA .
CONCLUSIONS	Results are expected in early 2016 .

###24550153
BACKGROUND	Developing Web-based physical activity ( PA ) interventions based on motivational interviewing ( MI ) could increase the availability and reach of MI techniques for PA promotion .
BACKGROUND	Integrating an avatar in such an intervention could lead to more positive appreciation and higher efficacy of the intervention , compared to an intervention that is purely text-based .
OBJECTIVE	The present study aims to determine whether a Web-based PA intervention based on MI with an avatar results in more positive appreciation and higher effectiveness of the intervention , when compared to an intervention that is purely text-based .
METHODS	A three-arm randomized controlled trial was conducted , containing the following research conditions : ( 1 ) a Web-based PA intervention based on MI with an avatar , ( 2 ) a content-identical intervention without an avatar , and ( 3 ) a control condition that received no intervention .
METHODS	Measurements included PA behavior and process variables , measured at baseline , directly following the intervention and 1 month post intervention .
RESULTS	Both interventions significantly increased self-reported PA at 1 month , compared to the control condition ( beta ( AVATARvsCONTROL ) = .39 , P = .011 ; beta ( TEXTvsCONTROL ) = .44 , P = .006 ) .
RESULTS	No distinctions were found regarding intervention effect on PA between both interventions .
RESULTS	Similarly , the results of the process evaluation did not indicate any significant differences between both interventions .
RESULTS	Due to the limited relational skills of the avatar in this study , it probably did not succeed in forming a stronger relationship with the user , over and above text alone .
CONCLUSIONS	The findings suggest that avatars that do not strengthen the social relationship with the user do not enhance the intervention impact .
CONCLUSIONS	Future research should determine whether Web-based PA interventions based on MI could benefit from inclusion of a virtual coach capable of more complex relational skills than used in the current study , such as responding in gesture to the user 's state and input .
BACKGROUND	Dutch Trial Register trial number : NTR3147 ; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3147 ( Archived by WebCite at http://www.webcitation.org/6NCbwdUJX ) .

###24652690
BACKGROUND	This multicentre international randomized trial compared the impact of gadoxetic acid-enhanced magnetic resonance imaging ( MRI ) , MRI with extracellular contrast medium ( ECCM-MRI ) and contrast-enhanced computed tomography ( CE-CT ) as a first-line imaging method in patients with suspected colorectal cancer liver metastases ( CRCLM ) .
METHODS	Between October 2008 and September 2010 , patients with suspected CRCLM were randomized to one of the three imaging modalities .
METHODS	The primary endpoint was the proportion of patients for whom further imaging after initial imaging was required for a confident diagnosis .
METHODS	Secondary variables included confidence in the therapeutic decision , intraoperative deviations from the initial imaging-based surgical plan as a result of additional operative findings , and diagnostic efficacy of the imaging modalities versus intraoperative and pathological extent of the disease .
RESULTS	A total of 360 patients were enrolled .
RESULTS	Efficacy was analysed in 342 patients ( 118 , 112 and 112 with gadoxetic acid-enhanced MRI , ECCM-MRI and CE-CT respectively as the initial imaging procedure ) .
RESULTS	Further imaging was required in 0 of 118 , 19 ( 17.0 per cent ) of 112 and 44 ( 39.3 per cent ) of 112 patients respectively ( P < 0.001 ) .
RESULTS	Diagnostic confidence was high or very high in 98.3 per cent of patients for gadoxetic acid-enhanced MRI , 85.7 per cent for ECCM-MRI and 65.2 per cent for CE-CT .
RESULTS	Surgical plans were changed during surgery in 28 , 32 and 47 per cent of patients in the respective groups .
CONCLUSIONS	The diagnostic performance of gadoxetic acid-enhanced MRI was better than that of CE-CT and ECCM-MRI as the initial imaging modality .
CONCLUSIONS	No further imaging was needed in the gadoxetic acid-enhanced MRI group and comparison of diagnostic efficacy parameters demonstrated the diagnostic superiority of gadoxetic acid-enhanced MRI .
BACKGROUND	NCT00764621 ( http://clinicaltrials.gov ) ; EudraCT number : 2008-000583-16 ( https://eudract.ema.europa.eu/ ) .

###25274174
BACKGROUND	School-based comprehensive sex education programs can reduce early adolescents ' risky sexual behavior .
BACKGROUND	The purpose of this study was to assess the effectiveness of a 3-year comprehensive sex education program in delaying vaginal sex for middle school students and whether the family component of the intervention contributes to its effectiveness .
METHODS	This longitudinal evaluation followed a cohort of 6th graders ( N = 2453 ) through the end of 8th grade .
METHODS	The design used random assignment of 24 schools into treatment and comparison conditions .
METHODS	The analysis included multiple-group logistic regression to assess differences in delay of sex between intervention and comparison groups .
RESULTS	In schools where the program was taught , 16 % fewer boys and 15 % fewer girls had had sex by the end of 8th grade compared to boys and girls at comparison schools .
RESULTS	Completing family activities during the first year of the program predicted delayed sexual debut for boys .
CONCLUSIONS	Theory-based , developmentally appropriate , comprehensive sex education programs that include parent involvement can be effective in delaying vaginal sex for middle school students .
CONCLUSIONS	Parent involvement is particularly important for boys , as family activities may encourage parents to talk with their sons earlier and more frequently .

###24913704
BACKGROUND	Acupuncture is commonly used to reduce pain during labour despite contradictory results .
BACKGROUND	The aim of this study is to evaluate the effectiveness of acupuncture with manual stimulation and acupuncture with combined manual and electrical stimulation ( electro-acupuncture ) compared with standard care in reducing labour pain .
BACKGROUND	Our hypothesis was that both acupuncture stimulation techniques were more effective than standard care , and that electro-acupuncture was most effective .
METHODS	A longitudinal randomised controlled trial .
METHODS	The recruitment of participants took place at the admission to the labour ward between November 2008 and October 2011 at two Swedish hospitals .
METHODS	303 nulliparous women with normal pregnancies were randomised to : 40minutes of manual acupuncture ( MA ) , electro-acupuncture ( EA ) , or standard care without acupuncture ( SC ) .
METHODS	labour pain , assessed by Visual Analogue Scale ( VAS ) .
RESULTS	relaxation , use of obstetric pain relief during labour and post-partum assessments of labour pain .
RESULTS	The sample size calculation was based on the primary outcome and a difference of 15mm on VAS was regarded as clinically relevant , this gave 101 in each group , including a total of 303 women .
RESULTS	Mean estimated pain scores on VAS ( SC : 69.0 , MA : 66.4 and EA : 68.5 ) , adjusted for : treatment , age , education , and time from baseline , with no interactions did not differ between the groups ( SC vs MA : mean difference 2.6 , 95 % confidence interval [ CI ] -1.7 -6.9 and SC vs EA : mean difference 0.6 [ 95 % CI ] -3.6 -4.8 ) .
RESULTS	Fewer number of women in the EA group used epidural analgesia ( 46 % ) than women in the MA group ( 61 % ) and SC group ( 70 % ) ( EA vs SC : odds ratio [ OR ] 0.35 ; [ 95 % CI ] 0.19-0 .67 ) .
CONCLUSIONS	Acupuncture does not reduce women 's experience of labour pain , neither with manual stimulation nor with combined manual and electrical stimulation .
CONCLUSIONS	However , fewer women in the EA group used epidural analgesia thus indicating that the effect of acupuncture with electrical stimulation may be underestimated .
CONCLUSIONS	These findings were obtained in a context with free access to other forms of pain relief .
BACKGROUND	ClinicalTrials.gov : NCT01197950 .

###26219154
OBJECTIVE	To compare-the adequacy of endometrium and the post-procedural pain between the manual vacuum aspiration ( MVA ) and metal curettage method .
METHODS	The present research was a clinical experiment .
METHODS	A randomized controlled trial study was done with older than 35-year oldfemales with abnormal intrauterine bleeding who attended the out-patient gynecology department of Maharat Nakhon Ratchasima Hospital between December 1 , 2013 and April 30 , 2014 .
METHODS	Patients were allocated with simple randomization technique into two groups , the experimental group was using MVA and the control group was using conventional metal uterine curettage .
METHODS	Pain levels were assessed according to the visual analogue scale .
METHODS	All tissue samples were examined by pathologists .
METHODS	Statistics used were percentage and Chi-square .
RESULTS	Percentages of tissue adequacy for pathological examination of control and experiment groups were 87.88 and 90.91 , respectively .
RESULTS	There was no significant difference between the two methods ( p-value = 0.572 ) .
RESULTS	The patients with severe pain in the experiment group were less than that of the control group .
RESULTS	The relative risk is 0.47 ( 95 % CI = 0.30-0 .72 ) .
CONCLUSIONS	MVA caused less pain than the metal curette method , while both provided the same rate of adequacy of endometrial tissue sampling for pathological diagnosis .
CONCLUSIONS	The MVA offered more humanized health care for gynecological patients who required such procedure .
CONCLUSIONS	Further researches focusing on the cost-effectiveness or medical complications could benefit a practice guideline and the health care system for this patient group .

###24373363
OBJECTIVE	Exposure to acute ` stressors ' ( e.g. infections , pain , trauma ) often results in altered sleep habits and reductions in routine activity .
OBJECTIVE	In some individuals , these behavioural responses to acute stressors may contribute to the development of chronic somatic symptoms such as widespread pain , fatigue , memory difficulties and mood disturbances , much like those associated with ` functional somatic syndromes ' ( FSS ) such as fibromyalgia or chronic fatigue syndrome .
METHODS	Eighty-seven healthy young adults who reported sleeping between 7 and 9 hours nightly and exercising regularly were randomised to one of four groups : exercise cessation , sleep restriction ( 6 hours nightly ) , both , or neither .
METHODS	Symptoms of pain , fatigue , cognitive dysfunction and negative mood were measured before and after the 10-day restriction period .
RESULTS	Sleep restriction was a potent contributor to the development of somatic symptoms .
RESULTS	Exercise cessation was less influential leading only to fatigue .
RESULTS	There were no significant interactions between exercise cessation and sleep restriction , except that males were much more likely to develop somatic symptoms when deprived of both sleep and exercise than one or the other .
RESULTS	Women were generally much more likely to develop somatic symptoms than men .
CONCLUSIONS	This study supports previous research suggesting that both sleep and exercise are critical in ` preventing ' somatic symptoms among some individuals .
CONCLUSIONS	Furthermore , to our knowledge , this is the first time there is data to suggest that women are much more sensitive to decrements in routine sleep and exercise than are men .

###25127878
BACKGROUND	Abused women , who suffer from chronic psychological stress , have been shown to have shorter telomeres than never abused women .
BACKGROUND	Telomere shortening is associated with increased risk of cell death , and it is believed that adopting health-promoting behaviors can help to increase the activity of telomerase , an enzyme that counters telomere shortening .
BACKGROUND	Qigong is an ancient Chinese mind-body integration , health-oriented practice designed to enhance the function of qi , an energy that sustains well-being .
BACKGROUND	Therefore , an assessor-blind , randomized , wait-list controlled trial was developed to evaluate the effect of a qigong intervention on telomerase activity ( primary objective ) and proinflammatory cytokines , perceived stress , perceived coping , and depressive symptoms ( secondary objectives ) in abused Chinese women .
METHODS	A total of 240 Chinese women , aged 18 years , who have been abused by an intimate partner within the past three years will be recruited from a community setting in Hong Kong and randomized to receive either a qigong intervention or wait-list control condition as follows : the qigong intervention will comprise ( i ) a 2-hour group qigong training session twice a week for 6 weeks , ( ii ) a 1-hour follow-up group qigong exercise session once a week for 4 months , and ( iii ) a 30-minute self-practice qigong exercise session once a day for 5.5 months .
METHODS	The wait-list control group will receive qigong training after the intervention group completes the program .
METHODS	Upon completion of the qigong intervention program , it is expected that abused Chinese women in the intervention group will have higher levels of telomerase activity and perceived coping and lower levels of proinflammatory cytokines , perceived stress , and depressive symptoms than will abused Chinese women in the wait-list control group .
CONCLUSIONS	This study will provide information about the effect of qigong exercise on telomerase activity and chronic psychological stress in abused Chinese women .
CONCLUSIONS	The findings will inform the design of interventions to relieve the effects of IPV-related psychological stress on health .
CONCLUSIONS	Also , the concept that health-promoting behaviors could slow down cellular aging might even motivate abused women to change their lifestyles .
BACKGROUND	Current Controlled Trials NCT02060123 .
BACKGROUND	Registered February 6 , 2014 .

###24706091
OBJECTIVE	The present study was to assess the reduction of right ventricular pacing ( RVP ) by pacemaker algorithms of Managed Ventricular Pacing ( MVP ) and Search AV + ( SAV + ) interval over a period of 12 months .
RESULTS	A total of 385 patients indicated for a dual-chamber pacemaker ( DC-PM ) were enrolled in the prospective , randomized COMPARE study at 29 centres in China between June 2009 and April 2011 .
RESULTS	Patients implanted with DC-PMs were randomized in a 1 : 1 ratio to the MVP group or the SAV + group .
RESULTS	The percentage of VP ( % VP ) was obtained from the device diagnostic data at 1 - , 6 - , and 12-month follow-ups and was expressed as the median % VP over all beats in patients with sinus node dysfunction ( SND ) and atrioventricular block ( AVB ) excluding persistent third-degree AVB .
RESULTS	Of 385 enrolled patients , 253 had SND and 72 had AVB .
RESULTS	The % VP in the MVP group was significantly lower than that in the SAV + group at 1 - , 6 - , and 12-month follow-ups , respectively .
RESULTS	At 12-month follow-up , the median % VP in SND patients was 0.20 % in the MVP group and 1.4 % in the SAV + group ( P < 0.0001 ) and the median % VP in AVB patients was 11.8 % in the MVP group and 98.1 % in the SAV + group ( P < 0.001 ) .
RESULTS	There was no statistical difference in % VP from 1 - to 12-month follow-up .
RESULTS	A trend in the correlation between % VP and AT/AF burden was observed .
CONCLUSIONS	Over 12-month follow-up , the % VP was lower for MVP than SAV + in patients with either SND or AVB .
CONCLUSIONS	The sustainable % VP reduction has potential implications in reducing the development of heart failure and/or atrial arrhythmia morbidity .

###25068301
BACKGROUND	Medical history is an important contributor to diagnosis and patient management .
BACKGROUND	In mass-casualty incidents ( MCIs ) , health care providers are often overwhelmed by large numbers of casualties .
BACKGROUND	An efficient , reliable , and affordable method of information collection is essential for effective health care response .
OBJECTIVE	In some MCIs , self-reporting of symptoms can decrease the time required for history taking , without sacrificing the completeness of triage information .
METHODS	Two resident doctors and a number of seventh graders who had previous experience of abdominal discomfort were invited to join this study .
METHODS	A questionnaire was developed to collect information on common symptoms in food poisoning .
METHODS	Each question was scored , and enrolled students were randomly divided into two groups .
METHODS	The experimental group students answered the questionnaire first and then were interviewed to complete the medical history .
METHODS	The control group students were interviewed in the traditional way to collect medical history .
METHODS	Time of all interviews was measured and recorded .
METHODS	The time needed to complete the history taking and completeness of obtained information were compared with students ' t tests , or Mann-Whitney U tests , based on the normality of data .
METHODS	Comprehensibility of each question , scored by enrolled students , was reported by descriptive statistics .
RESULTS	There were 41 students enrolled : 22 in the experimental group and 19 in the control group .
RESULTS	Time to complete history taking in the experimental group ( 163.0 seconds , SD = 52.3 ) was shorter than that in the control group ( 198.7 seconds , SD = 40.9 ) ( P = .010 ) .
RESULTS	There was no difference in the completeness of history obtained between the experimental group and the control group ( 94.8 % , SD = 5.0 vs 94.2 % , SD = 6.1 ; P = .747 ) .
RESULTS	Between the two doctors , no significant difference was found in the time required for history taking ( 185.2 seconds , SD = 42.2 vs 173.1 seconds , SD = 58.6 ; P = .449 ) , or the completeness of information ( 94.1 % , SD = 5.9 vs 95.0 % , SD = 5.0 ; P = .601 ) .
RESULTS	Most of the questions were scored `` good '' in comprehensibility .
CONCLUSIONS	Self-reporting of symptoms can shorten the time of history taking during a food poisoning mass-casualty event without sacrificing the completeness of information .

###25080458
BACKGROUND	Clinical weight loss in individuals typically stabilizes at 6 mo. .
BACKGROUND	However , validated models of dynamic energy balance have consistently shown weight plateaus between 1 and 2 y.
BACKGROUND	The cause for this discrepancy is unclear .
OBJECTIVE	We developed 2 mathematical models on the basis of the first law of thermodynamics to investigate plausible explanations for reaching an early weight plateau at 6 mo. .
METHODS	The first model was an energy-expenditure adaptation model and was applied to determine the degree of metabolic adaptation required to generate this plateau .
METHODS	The second model was an intermittent lack-of-adherence model formulated by using a randomly fluctuating energy intake term accounting for intermittent noncompliance in dietary intake to reach this plateau .
METHODS	To set model variables , validate models , and compare free-living weight-loss patterns to in-residence supervised programs , we applied the following 4 different studies : The US NHANES 1999-2004 , Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy ( CALERIE ) weight-loss study , the Bouchard Twin overfeeding study , and the Minnesota Starvation Experiment .
RESULTS	The metabolic adaptation model increased final weight but did not affect the predicted plateau time point .
RESULTS	The intermittent lack-of-adherence model generated oscillating weight graphs that have been frequently observed in weight-loss studies .
RESULTS	The model showed that a 6-mo weight-loss plateau can be attained despite what can be considered as high diet adherence .
RESULTS	The model was programmed as a downloadable application .
CONCLUSIONS	An intermittent lack of diet adherence , not metabolic adaptation , is a major contributor to the frequently observed early weight-loss plateau .
CONCLUSIONS	The new weight-loss prediction software , which incorporates an intermittent lack of adherence , can be used to guide and inform patients on realistic levels of adherence on the basis of patient lifestyle .

###25374039
OBJECTIVE	Despite sincere commitment to egalitarian , meritocratic principles , subtle gender bias persists , constraining women 's opportunities for academic advancement .
OBJECTIVE	The authors implemented a pair-matched , single-blind , cluster randomized , controlled study of a gender-bias-habit-changing intervention at a large public university .
METHODS	Participants were faculty in 92 departments or divisions at the University of Wisconsin-Madison .
METHODS	Between September 2010 and March 2012 , experimental departments were offered a gender-bias-habit-changing intervention as a 2.5-hour workshop .
METHODS	Surveys measured gender bias awareness ; motivation , self-efficacy , and outcome expectations to reduce bias ; and gender equity action .
METHODS	A timed word categorization task measured implicit gender/leadership bias .
METHODS	Faculty completed a work-life survey before and after all experimental departments received the intervention .
METHODS	Control departments were offered workshops after data were collected .
RESULTS	Linear mixed-effects models showed significantly greater changes post intervention for faculty in experimental versus control departments on several outcome measures , including self-efficacy to engage in gender-equity-promoting behaviors ( P = .013 ) .
RESULTS	When 25 % of a department 's faculty attended the workshop ( 26 of 46 departments ) , significant increases in self-reported action to promote gender equity occurred at three months ( P = .007 ) .
RESULTS	Post intervention , faculty in experimental departments expressed greater perceptions of fit ( P = .024 ) , valuing of their research ( P = .019 ) , and comfort in raising personal and professional conflicts ( P = .025 ) .
CONCLUSIONS	An intervention that facilitates intentional behavioral change can help faculty break the gender bias habit and change department climate in ways that should support the career advancement of women in academic medicine , science , and engineering .

###25046847
OBJECTIVE	In a study of 266 chronic hepatitis B e antigen ( HBeAg ) - positive patients , 23 experienced hepatitis B surface antigen ( HBsAg ) loss with up to 5 years of tenofovir disoproxil fumarate ( TDF ) treatment .
OBJECTIVE	HBsAg kinetics in patients with and without HBsAg loss and predictors of HBsAg loss were evaluated .
METHODS	HBsAg levels were quantified every 12 weeks .
METHODS	A multivariable regression analysis , involving prespecified baseline characteristics and on-treatment response parameters , was performed ; a stepwise procedure identified independent predictors of HBsAg loss .
RESULTS	Among patients with HBsAg loss , 14 ( 61 % ) , 1 ( 4 % ) , 0 and 7 ( 30 % ) were genotypes A through D , respectively ; 1 ( 4 % ) was genotype F. HBsAg loss was preceded by viral suppression ( HBV DNA < 29 IU/ml ; n = 23 ) and HBeAg loss ( n = 19 ) .
RESULTS	Among treated patients the strongest independent predictors of HBsAg loss were Caucasian race with genotype A/D and 4 years of infection ( HR = 14.3 , 95 % confidence interval [ CI ] 4.7-43 .4 ; p < 0.0001 ) and an HBsAg decline of 1 log10 IU/ml at week 24 ( HR = 13.7 , 95 % CI 5.6-33 .7 ; p < 0.0001 ) .
RESULTS	Among TDF-treated patients , a reduction in HBsAg level of 1-log10 by week 12 or 24 had a positive predictive value of 35 % -45 % , respectively , and a negative predictive value of 94 % -97 % , respectively .
CONCLUSIONS	HBsAg loss in HBeAg-positive patients receiving TDF involves a chronology of virologic and serologic responses ; patients with HBV genotypes A or D and a rapid early decline in HBsAg are more likely to lose HBsAg .

###25041577
OBJECTIVE	This is a secondary analysis of a randomized clinical trial which aims to examine changes in cognitive and behavioral responses to migraine with cognitive behavioral treatment for migraine , preventive medication for migraine , and their combination , and the relationship between these changes and reductions in migraine-related disability .
BACKGROUND	Cognitive behavioral treatment is thought to reduce migraine-related disability through modifying maladaptive cognitive and behavioral responses to migraine .
METHODS	Two hundred thirty-two people with migraine who did not respond to 5 weeks of optimized acute therapy were randomized into a 2 ( beta-blocker vs placebo ) X 2 ( behavioral migraine management [ BMM ] vs no BMM ) treatment design .
METHODS	Participants received BMM and/or beta-blocker dose adjustment for 4 months , and were followed for an additional 12 months .
METHODS	Participants completed measures of catastrophizing , behavioral coping , and migraine-related disability throughout the study .
RESULTS	Compared to drug therapy only , BMM demonstrated larger decreases in catastrophizing scores ( 19.16 to 9.89 vs 16.78 to 11.84 , P < .001 ) and increases in number of positive coping strategies ( proactive : 1.09 to 1.90 vs 1.16 to 1.09 , P < .001 ; anticipatory : 0.19 to 0.69 vs 0.10 to 0.08 , P < .001 ; migraine management : 0.14 to 0.36 vs 0.04 to 0.04 , P < .001 ) at the end of the follow-up period .
RESULTS	Decreases in catastrophizing were associated with a larger BMM effect on migraine-related disability ( P = .036 ) .
CONCLUSIONS	This study demonstrated that BMM modified important cognitive and behavioral factors postulated to be mechanisms of cognitive behavioral treatments for migraine .

###26336692
BACKGROUND	There is evidence from large clinical trials that compliance with standardized best practice guidelines ( BPGs ) improves survival of acute coronary syndrome ( ACS ) patients .
BACKGROUND	However , their application is often suboptimal .
OBJECTIVE	In this study , the researchers evaluated whether the use of an interactive voice response ( IVR ) follow-up system improved ACS BPG compliance .
METHODS	This was a single-centre randomized control trial ( RCT ) of 1,608 patients ( IVR = 803 ; usual care = 805 ) .
METHODS	The IVR group received five automated calls in 12 months .
METHODS	The primary composite outcome was increased medication compliance and decreased adverse events .
RESULTS	A significant improvement of 60 % in the IVR group for the primary composite outcome was found ( RR 1.60 , 95 % CI : 1.29 to 2.00 , p < 0.001 ) .
RESULTS	There was significant improvement in medication compliance ( p < 0.001 ) and decrease in unplanned medical visits ( p = 0.023 ) .
RESULTS	At one year , the majority of patients ( 85 % ) responded positively to using the system again .
RESULTS	Follow-up by IVR produced positive outcomes in ACS patients .

###24315152
BACKGROUND	Although a large isolated surface area of the left atrium ( LA ) may improve the success rate of catheter ablation ( CA ) for paroxysmal atrial fibrillation ( AF ) , little is known about the relation between clinical outcomes and the amount of atrial mass reduction ( AMR : ratio of total isolated and ablated areas to LA surface area ) in different ablation strategies for patients with long-standing persistent AF ( L-PeAF ) .
METHODS	We randomly assigned 119 consecutive L-PeAF patients to adjunctive linear ablation ( n = 60 ) or complex fractionated atrial electrogram ( CFAE ) - guided ablation ( n = 59 ) after circumferential antral pulmonary vein isolation ( PVI ) .
METHODS	Linear lesions included roof and anterior lines with conduction block .
METHODS	LA defragmentation was performed with an automated CFAE-detection algorithm .
METHODS	Cavotricuspid isthmus block was performed in all patients .
METHODS	Creatine kinase-MB ( CK-MB ) and troponin-T levels were measured 1 day post-CA .
RESULTS	CK-MB and troponin-T levels were higher , ablation time was longer , and AMR was greater in the CFAE-guided ablation group than in the linear ablation group .
RESULTS	AF termination during CA was more frequently observed in the linear ablation group than in the CFAE-guided ablation group ( P = 0.031 ) .
RESULTS	Twelve months after a single procedure , recurrence occurred in 16 ( 26.7 % ) patients with linear ablation and 27 ( 45.8 % ) patients with CFAE-guided ablation ( P = 0.023 ) .
RESULTS	On multivariate analysis , LA volume and ablation method were the only independent risk factors for arrhythmia recurrence .
CONCLUSIONS	Conduction block through linear lines + PVI was an efficient ablation strategy for L-PeAF , whereas the AMR amount did not influence clinical outcomes .

###24906406
BACKGROUND	Around 30 % to 62 % of older individuals fall each year , with adverse consequences of falls being by no means limited to physical injury and escalating levels of dependence .
BACKGROUND	Many older individuals suffer from a variety of adverse psychosocial difficulties related to falling including fear , anxiety , loss of confidence and subsequent increasing activity avoidance , social isolation and frailty .
BACKGROUND	Such ` fear of falling ' is common and disabling , but definitive studies examining the effective management of the syndrome are lacking .
BACKGROUND	Cognitive behavioural therapy has been trialed with some success in a group setting , but there is no adequately powered randomised controlled study of an individually based cognitive behavioural therapy intervention , and none using non-mental health professionals to deliver the intervention .
METHODS	We are conducting a two-phase study examining the role of individual cognitive behavioural therapy delivered by healthcare assistants in improving fear of falling in older adults .
METHODS	In Phase I , the intervention was developed and taught to healthcare assistants , while Phase II is the pragmatic randomised controlled study examining the efficacy of the intervention in improving fear of falling in community-dwelling elders attending falls services .
METHODS	A qualitative process evaluation study informed by Normalization Process Theory is being conducted throughout to examine the potential promoters and inhibitors of introducing such an intervention into routine clinical practice , while a health economic sub-study running alongside the trial is examining the costs and benefits of such an approach to the wider health economy .
BACKGROUND	Current Controlled Trials ISRCTN78396615 .

###24847017
BACKGROUND	This study sought to determine whether the 1-year differences in major adverse cardiac event between a stent eluting biolimus from a biodegradable polymer and bare-metal stents ( BMSs ) in the COMFORTABLE trial ( Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction ) were sustained during long-term follow-up .
RESULTS	A total of 1161 patients were randomly assigned to biolimus-eluting stent ( BES ) and BMS at 11 centers , and follow-up rates at 2 years were 96.3 % .
RESULTS	A subgroup of 103 patients underwent angiography at 13 months .
RESULTS	At 2 years , differences in the primary end point of cardiac death , target-vessel myocardial infarction , and target lesion revascularization continued to diverge in favor of BES-treated patients ( 5.8 % ) compared with BMS-treated patients ( 11.9 % ; hazard ratio = 0.48 ; 95 % confidence interval , 0.31-0 .72 ; P < 0.001 ) with a significant risk reduction during the second year of follow-up ( hazard ratio 1-2 years = 0.45 ; 95 % confidence interval , 0.20-1 .00 ; P = 0.049 ) .
RESULTS	Differences in the primary end point were driven by a reduction in target lesion revascularization ( 3.1 % versus 8.2 % ; P < 0.001 ) and target-vessel reinfarction ( 1.3 % versus 3.4 % ; P = 0.023 ) .
RESULTS	The composite of death , any reinfarction and revascularization ( 14.5 % versus 19.3 % ; P = 0.03 ) , and cardiac death or target-vessel myocardial infarction ( 4.2 % versus 7.2 % ; P = 0.036 ) were less frequent among BES-treated patients compared with BMS-treated patients .
RESULTS	The 13-month angiographic in-stent percent diameter stenosis amounted to 12.0 7.2 in BES - and 39.6 25.2 in BMS-treated lesions ( P < 0.001 ) .
CONCLUSIONS	Among patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention , BES continued to improve cardiovascular events compared with BMS beyond 1 year .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NTC00962416 .

###24244339
BACKGROUND	Ad35.CS .01 is a pre-erythrocytic malaria candidate vaccine .
BACKGROUND	It is a codon optimized nucleotide sequence representing the P. falciparum circumsporozoite ( CS ) surface antigen inserted in a replication deficient Adenovirus 35 backbone .
BACKGROUND	A Phase 1a trial has been conducted in the USA in nave adults and showed that the vaccine was safe .
BACKGROUND	The aim of this study is to assess the safety and immunogenicity of ascending dosages in sub Saharan Africa .
METHODS	A double blind , randomized , controlled , dose escalation , phase Ib trial was conducted in a rural area of Balonghin , the Sapon health district ( Burkina Faso ) .
METHODS	Forty-eight healthy adults aged 18-45 years were randomized into 4 cohorts of 12 to receive three vaccine doses ( day 0 , 28 and 84 ) of 10 ( 9 ) , 10 ( 10 ) , 5X10 ( 10 ) , 10 ( 11 ) vp of Ad35.CS .01 or normal saline by intra muscular injection .
METHODS	Subjects were monitored carefully during the 14 days following each vaccination for non serious adverse events .
METHODS	Severe and serious adverse events were collected throughout the participant study duration ( 12 months from the first vaccination ) .
METHODS	Humoral and cellular immune responses were measured on study days 0 , 28 , 56 , 84 , 112 and 140 .
RESULTS	Of the forty-eight subjects enrolled , forty-four ( 91.7 % ) received all three scheduled vaccine doses .
RESULTS	Local reactions , all of mild severity , occurred in thirteen ( 27.1 % ) subjects .
RESULTS	Severe ( grade 3 ) laboratory abnormalities occurred in five ( 10.4 % ) subjects .
RESULTS	One serious adverse event was reported and attributed to infection judged unrelated to vaccine .
RESULTS	The vaccine induced both antibody titers and CD8 T cells producing IFN and TNF with specificity to CS while eliciting modest neutralizing antibody responses against Ad35 .
CONCLUSIONS	Study vaccine Ad35.CS .01 at four different dose levels was well-tolerated and modestly immunogenic in this population .
CONCLUSIONS	These results suggest that Ad35.CS .01 should be further investigated for preliminary efficacy in human challenge models and as part of heterologous prime-boost vaccination strategies .
BACKGROUND	ClinicalTrials.gov NCT01018459 http://clinicaltrials.gov/ct2/show/NCT01018459 .

###24524866
OBJECTIVE	Diagnostic injections are used to diagnose myriad pain conditions , but are characterized by a high false-positive rate .
OBJECTIVE	One potential cause of inaccurate diagnostic blocks is the use of sedation .
OBJECTIVE	We sought to determine the effect of sedation on the validity of diagnostic injections .
METHODS	Randomized , crossover study in which 73 patients were allocated to receive a diagnostic sacroiliac joint or sympathetic nerve block performed either with or without sedation using midazolam and fentanyl .
METHODS	Those who obtained equivocal relief , good relief lasting less than 3 months , or who were otherwise deemed good candidates for a repeat injection , received a subsequent crossover injection within 3 months ( N = 46 ) .
METHODS	A tertiary care teaching hospital and a military treatment facility .
RESULTS	In the primary crossover analysis , blocks performed with sedation resulted in a larger mean reduction in pain diary score than those done without sedation ( 1.2 [ 2.6 ] ; P = 0.006 ) , less procedure-related pain ( difference in means 2.3 [ 2.5 ] ; P < 0.0001 ) , and a higher proportion of patients who obtained > 50 % pain relief on their pain diaries ( 70 % vs. 54 % ; P = 0.039 ) .
RESULTS	The increased pain reduction was not accompanied by increased satisfaction ( sedation mean 3.9 [ 1.1 ] vs. 3.7 [ 1.3 ] ; P = 0.26 ) .
RESULTS	Similar findings were observed for the parallel group ( N = 73 ) and omnibus ( all sedation vs. no sedation blocks , N = 110 ) analyses .
RESULTS	No differences in outcomes were noted between the use and non-use of sedation at 1-month .
CONCLUSIONS	The use of sedation during diagnostic injections may increase the rate of false-positive blocks and lead to misdiagnoses and unnecessary procedures , but has no effect on satisfaction or outcomes at 1-month .

###25697851
BACKGROUND	Biventricular pacing in heart failure ( HF ) improves survival , relieves symptoms , and attenuates left ventricular ( LV ) remodeling .
BACKGROUND	However , little is known about biventricular pacing in HF patients with atrioventricular block because they are typically excluded from biventricular trials .
RESULTS	The Biventricular versus Right Ventricular Pacing in Heart Failure Patients with Atrioventricular Block ( BLOCK HF ) trial randomized patients with atrioventricular block , New York Heart Association symptom classes I to III HF , and LV ejection fraction 50 % to biventricular or right ventricular pacing .
RESULTS	Doppler echocardiograms were obtained at randomization ( after 30 to 60 days of right ventricular pacing postimplant ) and every 6 months through 24 months .
RESULTS	Data analysis comparing changes in 10 prespecified echo parameters over time was conducted using a Bayesian design .
RESULTS	LV end systolic volume index was also evaluated as a predictor of mortality/morbidity .
RESULTS	Of 691 randomized subjects , 624 had paired Doppler echocardiogram data for 1 analyses at 6 , 12 , 18 , or 24 months .
RESULTS	Biventricular pacing significantly reduced LV volume indices and intraventricular mechanical delay , and improved LV ejection fraction , consistent with LV reverse remodeling .
RESULTS	These parameters showed little change with right ventricular pacing alone , indicating no systematic reverse remodeling with right ventricular pacing .
RESULTS	LV end systolic volume index was predictive of mortality/morbidity ; the estimated risk increased up to 1 % for every 1 mL/m ( 2 ) increase in LV end systolic volume index .
CONCLUSIONS	LV end systolic volume index is a significant predictor of mortality/morbidity in this population .
CONCLUSIONS	Cardiac structure and function are improved with biventricular pacing for patients with atrioventricular block and LV systolic dysfunction .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00267098 .

###25081522
OBJECTIVE	To compare the efficacy , safety and postoperative pain of mechanical versus transepithelial photorefractive keratectomy ( PRK ) techniques .
METHODS	Cornea and refractive surgery subspecialty .
METHODS	Prospective clinical trial .
METHODS	This prospective comparative study included 84 eyes of 42 patients with myopia who received mechanical PRK ( m-PRK ) in 1 eye and transepithelial PRK ( t-PRK ) in the contralateral eye .
METHODS	The mean patient age was 28.56.3 years ( range 20-46 years ) .
METHODS	Postoperative uncorrected distance visual acuity ( UDVA ) , corrected distance visual acuity ( CDVA ) , manifest refractions , postoperative epithelial healing time , surgical time , postoperative pain rating and corneal haze were recorded .
RESULTS	At week 1 , statistically the UDVA was significantly better in the t-PRK eyes ; however , at 3 months , similar refractive stability was achieved in both groups .
RESULTS	The mean spherical equivalent ( SE ) decreased from -2.441.00 D ( m-PRK eyes ) and -2.881.24 D ( t-PRK eyes ) at baseline to -0.190.38 D and -0.300.40 D , respectively , after 1 year .
RESULTS	Surgical time was 98.69.8 s in m-PRK eyes and 58.06.4 s in t-PRK eyes .
RESULTS	On postoperative days 1 and 3 , using the global assessment rating , 81 % of mPRK eyes that had pain , reported more pain than that reported for the tPRK eyes .
RESULTS	In addition , m-PRK treated eyes demonstrated higher mean pain scores based on the 11-point numerical rating scale and Visual Analogue Scale ( VAS ) .
RESULTS	The mean time to complete epithelial healing was 2.190.39 days ( t-PRK ) and 3.760.43 days ( m-PRK ) .
CONCLUSIONS	t-PRK for mild-to-moderate myopia was more comfortable than conventional m-PRK ; patients had less pain , and faster healing time .

###24661661
OBJECTIVE	To report late toxicity outcomes from a randomized trial comparing conventional and hypofractionated prostate radiation therapy and to identify dosimetric and clinical parameters associated with late toxicity after hypofractionated treatment .
METHODS	Men with localized prostate cancer were enrolled in a trial that randomized men to either conventionally fractionated intensity modulated radiation therapy ( CIMRT , 75.6 Gy in 1.8-Gy fractions ) or to dose-escalated hypofractionated IMRT ( HIMRT , 72 Gy in 2.4-Gy fractions ) .
METHODS	Late ( 90 days after completion of radiation therapy ) genitourinary ( GU ) and gastrointestinal ( GI ) toxicity were prospectively evaluated and scored according to modified Radiation Therapy Oncology Group criteria .
RESULTS	101 men received CIMRT and 102 men received HIMRT .
RESULTS	The median age was 68 , and the median follow-up time was 6.0 years .
RESULTS	Twenty-eight percent had low-risk , 71 % had intermediate-risk , and 1 % had high-risk disease .
RESULTS	There was no difference in late GU toxicity in men treated with CIMRT and HIMRT .
RESULTS	The actuarial 5-year grade 2 GU toxicity was 16.5 % after CIMRT and 15.8 % after HIMRT ( P = .97 ) .
RESULTS	There was a nonsignificant numeric increase in late GI toxicity in men treated with HIMRT compared with men treated with CIMRT .
RESULTS	The actuarial 5-year grade 2 GI toxicity was 5.1 % after CIMRT and 10.0 % after HIMRT ( P = .11 ) .
RESULTS	In men receiving HIMRT , the proportion of rectum receiving 36.9 Gy , 46.2 Gy , 64.6 Gy , and 73.9 Gy was associated with the development of late GI toxicity ( P < .05 ) .
RESULTS	The 5-year actuarial grade 2 GI toxicity was 27.3 % in men with R64 .6 Gy 20 % but only 6.0 % in men with R64 .6 Gy < 20 % ( P = .016 ) .
CONCLUSIONS	Dose-escalated IMRT using a moderate hypofractionation regimen ( 72 Gy in 2.4-Gy fractions ) can be delivered safely with limited grade 2 or 3 late toxicity .
CONCLUSIONS	Minimizing the proportion of rectum that receives moderate and high dose decreases the risk of late rectal toxicity after this hypofractionation regimen .

###24758546
OBJECTIVE	High circulating levels of osteoprotegerin ( OPG ) carry prognostic impact in cohorts with various cardiovascular diagnoses .
OBJECTIVE	With the present study , we aim to investigate the role of OPG within the scale of myocardial damage .
METHODS	This study includes 219 consecutive patients with acute ST-elevation myocardial infarction randomized to primary percutaneous coronary intervention ( pPCI ) or pPCI and remote ischemic per-conditioning .
METHODS	Salvage index via myocardial single-photon emission CT assessment ( data available in 61 % of the patients ) was performed , and derived from Day 1 ( myocardial area at risk ) and Day 30 ( final infarct size ) .
METHODS	Plasma OPG levels were measured using an in-house immunoassay .
METHODS	A combined end-point of all-mortality , myocardial infarction , stroke , readmission for heart failure and ischemic stroke/transient ischemic attack ( Major Adverse Cardiac and Cerebrovascular Events [ MACCE ] ) was used for follow-up ; 45 ( 38-48 months ) .
RESULTS	High OPG levels were associated with the severity of cardiovascular disease .
RESULTS	During follow-up , OPG was a predictor of MACCE ( unadjusted , HR : 2.1 , 95 % CI : 1.14-3 .85 , P = 0.017 ) .
RESULTS	Adjustments for age , gender , and body mass index preserved the independent predictive power of OPG .
RESULTS	However , OPG levels were neither associated with salvage index nor with the final infarct size .
RESULTS	Remote ischemic per-conditioning had no effect on OPG levels .
CONCLUSIONS	Despite absent association between OPG levels and the scale of myocardial damage , high OPG levels predict a significantly increased risk of MACCE .

###26001844
BACKGROUND	Life expectancy in patients with schizophrenia is reduced by 20years for males and 15years for females compared to the general population .
BACKGROUND	About 60 % of the excess mortality is due to physical illnesses , with cardiovascular disease being the single largest cause of death .
METHODS	The CHANGE trial is an investigator-initiated , independently funded , randomized , parallel-group , superiority , multi-centre trial with blinded outcome assessment .
METHODS	450 patients aged 18years or above , diagnosed with schizophrenia spectrum disorders and increased waist circumference , will be recruited and randomized 1:1:1 to 12-months interventions .
METHODS	We will compare the effects of 1 ) affiliation to the CHANGE team , offering a tailored , manual-based intervention targeting physical inactivity , unhealthy dietary habits , and smoking , and facilitating contact to their general practitioner to secure medical treatment of somatic comorbidity ; versus 2 ) affiliation to a care coordinator who will secure guideline-concordant monitoring and treatment of somatic comorbidity by facilitating contact to their general practitioner ; versus 3 ) treatment as usual to evaluate the potential add-on effects of lifestyle coaching plus care coordination or care coordination alone to treatment as usual .
METHODS	The primary outcome is the 10-year risks of cardiovascular disease assessed at 12months after randomization .
CONCLUSIONS	The premature mortality observed in this vulnerable population has not formerly been addressed specifically by using composite surrogate outcomes for mortality .
CONCLUSIONS	The CHANGE trial expands the evidence for interventions aiming to reduce the burden of metabolic disturbances with a view to increase life expectancy .
CONCLUSIONS	Here , we present the trial design , describe the methodological concepts in detail , and discuss the rationale and challenges of the intermediate outcomes .
BACKGROUND	Clinical Trials.gov NCT01585493 .
BACKGROUND	Date of registration 27 ( th ) of March 2012 .

###24735100
BACKGROUND	Implanted insulin pumps using the peritoneal route provide long-term improvement of glucose control compared with subcutaneous insulin therapy in type 1 diabetes ( T1D ) patients .
BACKGROUND	The stability of insulin preparation is critical for a safe use in implanted pumps .
BACKGROUND	Insuman implantable ( ) ( 400IU/mL ) ( Sanofi-Aventis Deutschland GmbH , Frankfurt am Main , Germany ) , a recombinant human insulin , has been developed as a replacement for Insuplant ( ) ( Aventis Pharma , Frankfurt am Main , Germany ) , a semisynthetic insulin , the only one used so far .
BACKGROUND	The aim of the study was to demonstrate the noninferiority of Insuman versus Insuplant , in terms of safety and effectiveness when used in implanted pumps .
METHODS	The patients enrolled , currently treated for T1D by the Medtronic MiniMed ( Northridge , CA ) implantable pump model 2007 with Insuplant , were randomized into two study arms and received either Insuman or Insuplant for four pump refill cycles .
METHODS	Each pump refill cycle was 405 days .
METHODS	The co-primary end points included glycated hemoglobin ( HbA1c ) change from baseline and pump infusion accuracy .
RESULTS	In total , 169 patients were randomized .
RESULTS	Noninferiority of Insuman versus Insuplant was demonstrated both for the HbA1c change from baseline ( as a percentage ) with intergroup difference of 95 % confidence interval ( -0.36 ; +0.11 ) and for the infusion accuracy assessed by the measured percentage of error at pump refill , as shown by intergroup difference of 95 % confidence interval ( -5.81 ; -0.50 ) , in per-protocol populations , although the insulin daily dose was similar .
RESULTS	Severe hypoglycemia occurred at least once in 12 versus 11 patients , respectively , and metabolic or technical adverse events were comparable .
CONCLUSIONS	Findings suggest that Insuman can safely and effectively replace Insuplant in implanted pumps .

###24695064
OBJECTIVE	To compare laser photocoagulation plans for diabetic macular edema ( DME ) using fluorescein angiography ( FA ) versus optical coherence tomography ( OCT ) thickness map superimposed on the retina .
METHODS	Fourteen eyes with DME undergoing navigated laser photocoagulation with navigated photocoagulator had FA taken using the same instrument .
METHODS	Optical coherence tomography central retinal thickness map was imported to the photocoagulator and with same magnification aligned onto the retina .
METHODS	Three retina specialists placed laser spot marks separately on FA and OCT image in a masked fashion .
METHODS	The spots placed by each physician were compared between FA and OCT and among physicians .
METHODS	The area of dye leakage on FA and increased central retinal thickness on OCT of the same eye were also compared .
RESULTS	The average number of spots using FA and OCT template was 36.64 and 40.61 , respectively ( P = 0.0201 ) .
RESULTS	The average area of dye leakage was 7.45 mm , whereas the average area of increased central retinal thickness on OCT of the same eye was 10.92 mm ( P = 0.013 ) .
CONCLUSIONS	There is variability in the treatment planning for macular photocoagulation with a tendency to place more spots when guided by OCT than by FA .
CONCLUSIONS	Integration of OCT map aligned to the retina may have an impact on treatment plan once such information is available .

###25172986
OBJECTIVE	To evaluate the effectivity of a combined intervention of information and communication to reduce magnetic resonance imaging ( MRI ) anxiety using prolactin and cortisol as biochemical markers and State Trait Anxiety Inventory ( STAI ) .
METHODS	This study is a randomized prospective research .
METHODS	Sample size was 33 patients .
METHODS	Fourteen patients were enrolled as study group , compared to 19 patients as control group .
METHODS	Blood samples were collected by venous sampling , and STAI was filled before and after scan .
METHODS	State anxiety inventory was used twice .
METHODS	Study group received a standard information about MRI scans and were communicated with 2 minute intervals via intercom ; control group had no intervention .
METHODS	Blood samples were carried in ice to be centrifuged and stored as soon as they were taken to study prolactin and cortisol .
METHODS	Data were stored and analyzed by SPSS 17.0 .
METHODS	P value for significance was accepted as 0.05 .
RESULTS	Prolactin-pre , prolactin-post , cortisol-pre , cortisol-post , cortisol percent increase , Trait Anxiety Inventory ( TAI ) , SAI ( State Anxiety Inventory ) pre-scan and post-scan levels were similar between demographic groups .
RESULTS	Cortisol-pre levels were similar between study and control , however prolactin-pre levels were significantly higher in control group .
RESULTS	Study group had 6 % lower cortisol level post-scan , whereas control group had 18 % increase .
RESULTS	Study and control groups had similar Trait Anxiety and SAI-pre scores .
RESULTS	SAI-post scores were lower in study group when compared with control group .
RESULTS	Study group also had lower SAI-post scores than SAI-pre , whereas control group had higher .
CONCLUSIONS	MRI anxiety can be reduced by information and communication .
CONCLUSIONS	This combined method is shown to be effective and should be used during daily radiology routine .

###24714489
BACKGROUND	Contrast-induced nephropathy ( CIN ) is a serious condition in patients with ST-segment-elevation myocardial infarction treated with primary percutaneous coronary intervention .
BACKGROUND	We compared the risk of acute CIN and the influence of preventive strategies in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention .
RESULTS	A total of 720 patients were randomized in the Prevention of Contrast-induced Nephropathy in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention ( CINSTEMI ) trial .
RESULTS	Patients were randomly assigned in a 1:1:1:1 ratio to receive hydration with sodium chloride together with 1 of 4 prophylactic regimes ( 1 ) N-acetylcysteine ( NAC ) , ( 2 ) sodium bicarbonate ( NaHCO3 ) infusion , ( 3 ) NAC in combination with NaHCO3 , or ( 4 ) hydration with sodium chloride infusion alone .
RESULTS	Patients in cardiogenic shock were excluded .
RESULTS	Acute CIN was defined as an increase in serum creatinine concentration > 25 % from the baseline value within a 3-day period .
RESULTS	Overall , CIN occurred in 141 ( 21.9 % ) patients .
RESULTS	The prevention treatment with NAC , NaHCO3 , or the combined NAC and NaHCO3 did not reduce the rate of CIN significantly compared with hydration with intravenous sodium chloride infusion alone ( 20.1 % versus 20.1 % versus 20.8 % versus 26.5 % ; P = NS ) .
RESULTS	However , an increase in serum creatinine > 25 % from the baseline value to 30 day was significantly lower in patients treated with combined NAC and NaHCO3 ( 18.7 % versus 19.1 % versus 9.2 % versus 21.3 % ; P = 0.033 ) .
CONCLUSIONS	Treatment with NAC or NaHCO3 did not reduce the rate of acute CIN significantly .
CONCLUSIONS	Combined treatment with NAC and NaHCO3 may reduce the risk of renal dysfunction after 30 days .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01160627 .

###24748629
OBJECTIVE	To evaluate the efficacy and safety of subcutaneous blisibimod , an inhibitor of B cell activating factor , in patients with systemic lupus erythematosus ( SLE ) in a dose-ranging Phase 2b clinical trial .
METHODS	547 patients with SLE with anti-double stranded DNA or antinuclear antibodies and Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index ( SELENA-SLEDAI ) score 6 at baseline were randomised to receive placebo or blisibimod at one of 3 dose levels .
METHODS	The primary end point , measured at Week 24 , was the SLE Responder Index-5 ( SRI-5 , meeting established SRI criteria but with 5 point improvement in SELENA-SLEDAI ) .
RESULTS	Although SRI-5 response rates were not significantly improved in the pooled blisibimod groups compared with placebo , they were higher in subjects randomised to the highest dose of blisibimod ( 200mg once-weekly ( QW ) ) compared with pooled placebo , from Week 16 to Week 24 , reaching statistical significance at Week 20 ( p = 0.02 ) .
RESULTS	SRI response rates compared with placebo were higher still in subjects who attained SELENA-SLEDAI improvements of 8 , and in a subgroup of patients with severe disease ( SELENA-SLEDAI 10 and receiving corticosteroids at baseline ) .
RESULTS	In subjects with protein : creatine ratios of 1-6 at baseline , significant reductions in proteinuria were observed with blisibimod .
RESULTS	Significant ( p < 0.01 ) changes in anti-double stranded DNA antibodies , complement C3 and C4 , and reductions in B cells were observed with blisibimod.No imbalances in serious adverse events or infections ( 4/280 and 3/266 ) , deaths ( 4/280 and 3/266 ) and malignancies ( 2/280 and 2/266 ) were reported for blisibimod compared with placebo .
CONCLUSIONS	This study successfully identified a safe , effective and convenient dose , study population and end point for evaluation of blisibimod effect in Phase 3 .
BACKGROUND	NCT01162681 .

###24812897
OBJECTIVE	To assess the efficacy and safety of Xifeng Zhidong Tablet ( XZT ) in treating tic disorder children patients of internal disturbance of Gan-wind with phlegm syndrome ( IDGWPS ) .
METHODS	A stratified randomized , double-blinded , parallel control of placebo , multi-center trial was conducted in 160 subjects from 5 hospitals in China .
METHODS	They were randomly assigned to 2 groups , the test group and the control group , 80 in each group .
METHODS	Those in the test group were treated with XZT , while those in the control group were treated with placebos .
METHODS	The therapeutic course was 4 weeks for all .
METHODS	The effectiveness indicators covered main indicators and secondary indicators .
METHODS	Yale global tic severity scale ( YGTSS ) was taken as the main indicators .
METHODS	The amelioration of social function impairment , efficacy , single index of Chinese medical syndromes , Chinese medical syndrome efficacy as well as disappearance rate of single Chinese medical symptoms were evaluated as secondary indicators .
METHODS	The safety indicators included clinical adverse events , vital signs , blood/urine/stool routines , renal and liver functions , and electrocardiogram ( ECG ) .
RESULTS	As for main indicators , the score of YGTSS decreased from 22.10 + / - 6.38 to 11.34 + / - 6.58 in the test group , while it decreased from 22.65 + / - 6.70 to 16.82 + / - 6.53 in the control group , showing statistical difference when compared with the same group before treatment ( P < 0.01 ) .
RESULTS	Besides , the decrement was more significant in the test group after treatment ( P < 0.05 ) .
RESULTS	As for secondary indicators , the total effective rate was 83.54 % in the test group and 34.18 % in the controlled group , showing statistical difference between the two groups ( P < 0.05 ) .
RESULTS	As for social function impairment , 20,38 , 16 , 3 , 1 case ( s ) in the test group were ranked as normal , minimal , mild , moderate , obvious degree , while 1 , 24 , 45 , 7 , and 0 case ( s ) in the control group were ranked as normal , minimal , mild , moderate , obvious degree .
RESULTS	Better effect was obtained in the test group ( P < 0.05 ) .
RESULTS	As for Chinese medical syndrome efficacy , it was 87.34 % in the test group and 64.56 % in the control group ( P < 0.05 ) .
RESULTS	As for single index of Chinese medical syndromes , the disappearance rate of motor tics , irritability , dreaminess , abnormal tongue proper , abnormal tongue fur , and abnormal tongue pulse condition was 78.67 % , 34.72 % , 62.26 % , 34.62 % , 58.97 % , and 39.74 % , respectively in the test group , while they were 34.67 % , 13.11 % , 21.82 % , 15.58 % , 25.97 % , and 19.48 % , respectively in the control group .
RESULTS	Better results were shown in the test group ( P < 0.05 ) .
RESULTS	Totally 5 adverse events occurred .
RESULTS	The incidence of adverse events was 3.75 % in the test group and 2.53 % in the control group .
CONCLUSIONS	After 4 weeks of XZT treatment , the integral of YGTSS could be obviously reduced , the degree of social function impairment ameliorated , and Chinese medical syndromes improved .
CONCLUSIONS	In addition , no adverse reaction occurred in this study .

###24224403
OBJECTIVE	The study sought to evaluate the influence of gastroesophageal reflux disease ( GERD ) and allergy on subacute rhinitis in infants .
METHODS	Mothers of 74 infants with subacute rhinitis completed the Infant Gastroesophageal Reflux Questionnaire Revised .
METHODS	Participants with GERD were randomized to undergo one of the following regimens for 10 days : use of fluorometholone nasal drops with positional and feeding changes ; positional and feeding changes ; or a placebo .
RESULTS	The daily amount of nasal secretion decreased by 75.9 % ( p < 0.001 ) , the intensity of swallowing difficulty by 79.2 % ( p < 0.001 ) , and the incidence of uneasiness by 92.0 % ( p < 0.001 ) in infants treated with nasal glucocorticoid and positional and feeding changes ; and the percentage differences in the amount of nasal secretion ( p < 0.001 ) , feeding difficulty ( p < 0.001 ) , and uneasiness ( p < 0.001 ) were greater than those in the group treated with positional and feeding changes .
RESULTS	The infants treated with placebo did not improve .
RESULTS	The influence of nasal allergy was nonsignificant .
CONCLUSIONS	Gastroesophageal reflux disease might contribute to aggravation of subacute rhinitis in infants .

###25232955
BACKGROUND	Several rehabilitation programmes aim at reducing the impact of fatigue in MS patients .
BACKGROUND	Acute and chronic fatigue should require different management .
OBJECTIVE	To assess the effects of individually tailored , multidisciplinary outpatient rehabilitation ( MDR ) on chronic fatigue .
METHODS	Forty-eight ambulatory MS patients with chronic fatigue were randomized to MDR or to MS-nurse consultation .
METHODS	Fatigue was assessed by the Checklist Individual Strength ( CIS-20R ) .
METHODS	Secondary outcomes included the Modified Fatigue Impact Scale , Fatigue Severity Scale , Functional Independence Measure , Disability and Impact Profile ( DIP ) , Multiple Sclerosis Impact Scale and the Impact on Participation and Autonomy ( IPA ) .
RESULTS	The primary outcome measure CIS-20R overall score showed no significant differences between groups at 12 weeks ( P = 0.39 ) and 24 weeks follow-up ( P = 0.14 ) , nor for subscales ( t = 12 and t = 24 , 0.19 P0 .88 ) .
RESULTS	No significant within-group effects were found for both groups with respect to the primary ( 0.57 p0 .97 ) and secondary ( 0.11 p0 .92 ) outcome measures from baseline to 12 or 24 weeks .
CONCLUSIONS	Multidisciplinary rehabilitation was not more effective in terms of reducing self-reported fatigue in MS patients compared to MS-nurse consultation .
CONCLUSIONS	Our results suggest that chronic fatigue in patients with MS may be highly invariant over time , irrespective of interventions .
BACKGROUND	controlled-trials .
BACKGROUND	com ISRCTN05017507 .

###25014687
BACKGROUND	Somatostatin analogues are commonly used to treat symptoms associated with hormone hypersecretion in neuroendocrine tumors ; however , data on their antitumor effects are limited .
METHODS	We conducted a randomized , double-blind , placebo-controlled , multinational study of the somatostatin analogue lanreotide in patients with advanced , well-differentiated or moderately differentiated , nonfunctioning , somatostatin receptor-positive neuroendocrine tumors of grade 1 or 2 ( a tumor proliferation index [ on staining for the Ki-67 antigen ] of < 10 % ) and documented disease-progression status .
METHODS	The tumors originated in the pancreas , midgut , or hindgut or were of unknown origin .
METHODS	Patients were randomly assigned to receive an extended-release aqueous-gel formulation of lanreotide ( Autogel [ known in the United States as Depot ] , Ipsen ) at a dose of 120 mg ( 101 patients ) or placebo ( 103 patients ) once every 28 days for 96 weeks .
METHODS	The primary end point was progression-free survival , defined as the time to disease progression ( according to the Response Evaluation Criteria in Solid Tumors , version 1.0 ) or death .
METHODS	Secondary end points included overall survival , quality of life ( assessed with the European Organization for Research and Treatment of Cancer questionnaires QLQ-C30 and QLQ-GI .
METHODS	NET21 ) , and safety .
RESULTS	Most patients ( 96 % ) had no tumor progression in the 3 to 6 months before randomization , and 33 % had hepatic tumor volumes greater than 25 % .
RESULTS	Lanreotide , as compared with placebo , was associated with significantly prolonged progression-free survival ( median not reached vs. median of 18.0 months , P < 0.001 by the stratified log-rank test ; hazard ratio for progression or death , 0.47 ; 95 % confidence interval [ CI ] , 0.30 to 0.73 ) .
RESULTS	The estimated rates of progression-free survival at 24 months were 65.1 % ( 95 % CI , 54.0 to 74.1 ) in the lanreotide group and 33.0 % ( 95 % CI , 23.0 to 43.3 ) in the placebo group .
RESULTS	The therapeutic effect in predefined subgroups was generally consistent with that in the overall population , with the exception of small subgroups in which confidence intervals were wide .
RESULTS	There were no significant between-group differences in quality of life or overall survival .
RESULTS	The most common treatment-related adverse event was diarrhea ( in 26 % of the patients in the lanreotide group and 9 % of those in the placebo group ) .
CONCLUSIONS	Lanreotide was associated with significantly prolonged progression-free survival among patients with metastatic enteropancreatic neuroendocrine tumors of grade 1 or 2 ( Ki-67 < 10 % ) .
CONCLUSIONS	( Funded by Ipsen ; CLARINET ClinicalTrials.gov number , NCT00353496 ; EudraCT 2005-004904-35 . )

###24377675
BACKGROUND	Endoscopic treatment of early neoplastic lesions in oesophagus has evolved as a valid and less invasive alternative to surgical resection .
BACKGROUND	These endoscopic interventions are minimal invasive treatment options usually done with sedation on an outpatient basis .
BACKGROUND	The aim of this trial is to determine the safety and effectiveness of dexmedetomidine sedation compared to the standard used propofol TCI sedation during endoscopic oesophageal interventions .
METHODS	The study will be performed as a randomized controlled trial .
METHODS	The first 64 consenting patients will be randomized to either the propofol or the dexmedetomidine group .
METHODS	Following endoscopy patients and gastroenterologists have to fill in questionnaires ( PSSI , CSSI ) ( see abbreviations ) about their sedation experiences .
METHODS	Additionally , patients have to accomplish the Trieger test before and after the procedure .
METHODS	Patient monitoring includes time adapted HR , SO , ECG , NIBP , exCO , NICO , sweat conductance measurement , OAA/S , and the Aldrete score .
METHODS	Effectiveness of sedation , classified by satisfaction levels and pain and sedation score measured by questionnaires is the primary outcome parameter .
METHODS	Respiratory and hemodynamic complications are surrogate parameters for the secondary outcome parameter `` safety '' .
CONCLUSIONS	The acceptance level among patients after propofol sedation is high .
CONCLUSIONS	Dexmedetomidine is a relatively new representative for procedural sedation .
CONCLUSIONS	Has this new form of conscious sedation the potential to be safer and more effective for patients and endoscopists than propofol during endoscopic oesophageal interventions ?
BACKGROUND	This trial is registered in the ISRCTN Register ( ISRCTN 68599804 ) .
BACKGROUND	It will be conducted in accordance with the protocol and in compliance with the moral , ethical , and scientific principles governing clinical research as set out in the Declaration of Helsinki ( 1989 ) and Good Clinical Practice ( GCP ) .
BACKGROUND	The Departments of Anesthesiology and Gastroenterology & Hepatology of the Academic Medical Center of Amsterdam are responsible for the design and conduct of the trial .

###24486089
OBJECTIVE	Anemia is a common adverse event associated with telaprevir-based triple therapy of chronic , genotype 1 hepatitis C. Identification of patients at risk of developing anemia could allow evaluation of suitability for therapy , and aid in determining frequency of anemia monitoring and treatment management .
METHODS	This post-hoc analysis utilized data from the no lead-in telaprevir , peginterferon and ribavirin arm of the REALIZE study .
METHODS	Anemia was defined as a single occurrence of hemoglobin < 10 g/dl at any point during treatment .
METHODS	Pre-treatment factors with potential to act as prognostic indicators of anemia including age , sex , BMI , and baseline hemoglobin were analysed by univariate and multivariate logistic regression analyses .
METHODS	Nomograms ( graphical representations of risk factors ) were developed to predict the likelihood of developing anemia .
RESULTS	Among the 265 patients , 102 ( 38 % ) had anemia , with 78/102 ( 77 % ) developing anemia on or before week 12 .
RESULTS	Most patients developed anemia after week 2 and an inverse correlation was found between week 2 hemoglobin and the likelihood of developing anemia .
RESULTS	Overall , 60 % of patients ( 60/100 ) with week 2 hemoglobin < 13 g/dl subsequently developed anemia .
RESULTS	The multivariate analysis revealed older age ( > 45 years ) , lower BMI ( 25 mg/m ( 2 ) ) and baseline hemoglobin ( continuous variable ) were significantly associated with the probability of developing anemia during telaprevir treatment .
CONCLUSIONS	These analyses indicate the potential of using predictive risk factors such as low baseline and on-treatment hemoglobin to identify patients at risk of developing anemia on telaprevir-based triple therapy , which may increase the potential for treatment success by careful patient monitoring .

###24559858
OBJECTIVE	After posterior urethral valve ablation , some boys are still have a hostile bladder .
OBJECTIVE	We conducted a prospective randomized study to determine if Botox injection at the bladder neck will help improve vesical dysfunction in this subgroup of boys or not .
METHODS	Twenty boys with history of posterior urethral valve ablation and severe bladder dysfunction with a mean age of 16 months were studied .
METHODS	Cases were further randomized into two groups .
METHODS	Group I ( study group ) had endoscopic injection of a single dose of 100 IU of Botox into the hypertrophied bladder neck at 3 , 6 , and 9 o'clock .
METHODS	Group II ( control group ) patients with the same parameters had urethroscopy to exclude residual valves .
METHODS	Both groups had the standard conservative treatment .
METHODS	Cases were followed after 6 months of initiating the management protocol .
METHODS	This includes laboratory studies ( urine culture and sensitivity , blood urea nitrogen , serum creatinine ) , ultrasound of the urinary tract .
METHODS	Voiding cysto-urethrogram and urodynamic study ( pressure flow study ) .
RESULTS	There was no statistical difference in both groups regarding rate of urinary tract infection , improvement of hydronephrosis , resolution of vesico-ureteral reflux , creatinine level at the start or at the end of the study .
RESULTS	Urodynamic parameters revealed an increase in cystometric capacity in both groups at the end of the study but without statistical difference .
RESULTS	The mean voiding pressure reduced significantly in both groups but without statistical difference .
CONCLUSIONS	Temporarily abolishing the effect of bladder neck by Botox injection does not seem to improve the outcome of those boys who had a severe voiding dysfunction after valve ablation .

###25103909
BACKGROUND	Heart rate variability ( HRV ) is reduced in stable ischemic heart disease ( SIHD ) patients and is associated with sudden cardiac death ( SCD ) .
BACKGROUND	We evaluated the impact of traditional acupuncture ( TA ) on cardiac autonomic function measured by HRV in SIHD patients .
METHODS	We conducted a randomized controlled study of TA , sham acupuncture ( SA ) , and waiting control ( WC ) in 151 SIHD subjects .
METHODS	The TA group received needle insertion at acupuncture sites , the SA group received a sham at non-acupuncture sites , while the WC group received nothing .
METHODS	The TA and SA groups received 3 treatments/week for 12 weeks .
METHODS	24-Hour , mental arithmetic stress , and cold pressor ( COP ) HRV was collected at entry and exit , along with BP , lipids , insulin resistance , hs-CRP , salivary cortisol , peripheral endothelial function by tonometry ( PAT ) , and psychosocial variables .
RESULTS	Mean age was 63 10 ; 50 % had prior myocardial infarction .
RESULTS	Comparison of WC and SA groups demonstrated differences consistent with the unblinded WC status ; therefore by design , the control groups were not merged .
RESULTS	Exit mental stress HRV was higher in TA vs. SA for markers of parasympathetic tone ( p 0.025 ) , including a 17 % higher vagal activity ( p = 0.008 ) .
RESULTS	There were no differences in exit 24-hour or COP HRV , BP , lipids , insulin resistance , hs-CRP , salivary cortisol , PAT , or psychosocial variables .
CONCLUSIONS	TA results in intermediate effects on autonomic function in SIHD patients .
CONCLUSIONS	TA effect on HRV may be clinically relevant and should be explored further .
CONCLUSIONS	These data document feasibility and provide sample size estimation for a clinical trial of TA in SIHD patients for the prevention of SCD .
CONCLUSIONS	We conducted a randomized , single-blind trial of traditional acupuncture ( TA ) vs. sham acupuncture ( SA ) vs waiting control ( WC ) in stable ischemic heart disease ( SIHD ) patients to evaluate cardiac autonomic function measured by heart rate variability ( HRV ) .
CONCLUSIONS	Exit mental stress HRV was higher in the TA compared to SA group for time and frequency domain markers of parasympathetic tone ( all p 0.025 ) , including a 17 % higher vagal activity ( p = 0.008 ) .
CONCLUSIONS	These data document feasibility and provide sample size estimation for an outcome-based clinical trial of TA in SIHD patients for the prevention of sudden cardiac death .

###24899759
OBJECTIVE	To evaluate the impact of nocturia on the therapeutic response of chronic insomnia to behavioral treatment in older adults .
METHODS	Secondary analysis of a randomized clinical trial designed to assess the efficacy of brief behavioral treatment of insomnia ( BBTI ) vs. an information-only control ( IC ) in 79 community-dwelling older adults with chronic insomnia .
METHODS	For the current analysis , participants were stratified into 2 groups : those with self-reported nocturia at baseline i.e. , 1 void/night ( N = 30 ; 16 IC , 14 BBTI ) and those without nocturia ( N = 49 ; 24 IC , 25 BBTI ) .
METHODS	We then determined the impact of BBTI on sleep , sleep quality , and nocturia as assessed by self-report , actigraphy , and polysomnography .
RESULTS	Individuals without baseline nocturia responded well to BBTI with significant decrease in sleep latency , wake after sleep onset , and total sleep time assessed by sleep diary and actigraphy ; these changes were significantly greater than those in the IC group .
RESULTS	In comparison , changes in the same sleep parameters among participants with nocturia were not significantly different from the IC control .
RESULTS	Although BBTI showed significant improvement in sleep quality in groups with and without nocturia ( as assessed by PSQI and sleep diary ) , the effect size of these improvements was larger in those without nocturia than in those with nocturia ( PSQI d = 0.82 vs. 0.53 , diary sleep quality d = 0.83 vs. 0.51 ) .
CONCLUSIONS	These secondary analyses suggest that brief behavioral treatment of insomnia may be more efficacious in improving insomnia in participants without nocturia .
CONCLUSIONS	Addressing nocturia may improve the efficacy of behavioral insomnia treatment .

###25022743
OBJECTIVE	To assess the effectiveness of a weighted-blanket intervention in treating severe sleep problems in children with autism spectrum disorder ( ASD ) .
METHODS	This phase III trial was a randomized , placebo-controlled crossover design .
METHODS	Participants were aged between 5 years and 16 years 10 months , with a confirmed ASD diagnosis and severe sleep problems , refractory to community-based interventions .
METHODS	The interventions were either a commercially available weighted blanket or otherwise identical usual weight blanket ( control ) , introduced at bedtime ; each was used for a 2-week period before crossover to the other blanket .
METHODS	Primary outcome was total sleep time ( TST ) recorded by actigraphy over each 2-week period .
METHODS	Secondary outcomes included actigraphically recorded sleep-onset latency , sleep efficiency , assessments of child behavior , family functioning , and adverse events .
METHODS	Sleep was also measured by using parent-report diaries .
RESULTS	Seventy-three children were randomized and analysis conducted on 67 children who completed the study .
RESULTS	Using objective measures , the weighted blanket , compared with the control blanket , did not increase TST as measured by actigraphy and adjusted for baseline TST .
RESULTS	There were no group differences in any other objective or subjective measure of sleep , including behavioral outcomes .
RESULTS	On subjective preference measures , parents and children favored the weighted blanket .
CONCLUSIONS	The use of a weighted blanket did not help children with ASD sleep for a longer period of time , fall asleep significantly faster , or wake less often .
CONCLUSIONS	However , the weighted blanket was favored by children and parents , and blankets were well tolerated over this period .

###24397355
BACKGROUND	In a subset of children with unilateral Cerebral Palsy ( CP ) a discrepancy between capacity and performance of the affected upper limb can be observed .
BACKGROUND	This discrepancy is known as Developmental Disregard ( DD ) .
BACKGROUND	Though the phenomenon of DD has been well documented , its underlying cause is still under debate .
BACKGROUND	DD has originally been explained based on principles of operant conditioning .
BACKGROUND	Alternatively , it has been proposed that DD results from a diminished automaticity of movements , resulting in an increased cognitive load when using the affected hand .
BACKGROUND	To investigate the amount of involved cognitive load we studied Event-Related Potentials ( ERPs ) preceding task-related motor responses during a single-hand capacity and a dual-hand performance task .
BACKGROUND	It was hypothesised that children with DD show alterations related to long-latency ERP components when selecting a response with the affected upper limb , reflecting increased cognitive load in order to generate an adequate response and especially so within the dual-hand task .
METHODS	Fifteen children with unilateral CP participated in the study .
METHODS	One of the participants was excluded due to major visual impairments .
METHODS	Seven of the remaining participants displayed DD .
METHODS	The other seven children served as a control group .
METHODS	All participants performed two versions of a cue-target paradigm , a single-hand capacity and a dual-hand performance task .
METHODS	The ERP components linked to target presentation were inspected : the mid-latency P2 component and the consecutive long-latency N2b component .
RESULTS	In the dual-hand performance task children with DD showed an enhancement in mean amplitude of the long-latency N2b component when selecting a response with their affected hand .
RESULTS	No differences were found regarding the amplitude of the mid-latency P2 component .
RESULTS	No differences were observed regarding the single-hand capacity task .
RESULTS	The control group did not display any differences in ERPs linked to target evaluation processes between both hands .
CONCLUSIONS	These electrophysiological findings show that DD is associated with increased cognitive load when movements are prepared with the affected hand during a dual-hand performance task .
CONCLUSIONS	These findings confirm behavioural observations , advance our insights on the neural substrate of DD and have implications for therapy .

###25534579
OBJECTIVE	Patients with Parkinson 's disease ( PD ) are at high risk for cognitive dysfunction .
OBJECTIVE	Non-pharmacological interventions have attracted increasing interest for enhancing PD patients ' cognitive functions .
METHODS	One-year follow-up data ( T2 ) of a randomized controlled trial evaluating two 6-week cognitive trainings - a structured ( NEUROvitalis , NV ) and an unstructured ( mentally fit , MF ) program - compared with a waiting list control group ( CG ) in non-demented PD patients ( Hoehn and Yahr I-III ) are presented .
METHODS	Forty-seven PD patients were examined at T2 .
METHODS	Effects on overall cognitive functions ( Mini-Mental State Examination and DemTect ) were compared between all groups with repeated measurement analyses of variance .
METHODS	A combined score of the percentage change value from baseline ( T0 ) to T2 was calculated to identify patients who retained or improved their cognitive state ( responders ) .
METHODS	The risk of developing mild cognitive impairment ( MCI ) was analyzed .
RESULTS	Significant time treatment effects on overall cognitive functions were found for both training groups , each compared separately to the CG ( DemTect , P < 0.05 ) .
RESULTS	Nine patients ( 56.3 % ) of the NV group , seven ( 41.2 % ) of the MF group and three ( 21.4 % ) of the CG were responders .
RESULTS	Comparing NV to CG the odds ratio was 4.7 [ 95 % confidence interval ( 0.8 ; 33.3 ) ] , and comparing MF to CG it was 2.6 [ 95 % confidence interval ( 0.4 ; 17.4 ) ] .
RESULTS	MCI risk for patients without prior MCI was 40.0 % in CG , 18.2 % in MF and 18.2 % in NV .
RESULTS	The odds ratio was 3 comparing NV to CG , MF to CG .
CONCLUSIONS	This study gives evidence that cognitive training may be effective to prevent cognitive decline and onset of MCI in PD patients .

###24385309
OBJECTIVE	The extended-release formulation of quetiapine ( quetiapine XR ) , which was developed to provide more convenient once-daily administration , has been widely studied to characterize its pharmacokinetics in Caucasian populations but has rarely been studied in an Asia population .
OBJECTIVE	This study was conducted to evaluate the pharmacokinetics and tolerability of quetiapine XR administered as a single dose ( 300 mg ) and multiple doses ( 300 , 600 , and 800 mg ) in Han Chinese patients with schizophrenia .
METHODS	This was a single-center , open-label , single-dose and multiple-dose randomized study .
METHODS	Among the 55 randomized subjects , a total of 40 female or male patients in 300 mg ( n = 13 ) , 600 mg ( n = 13 ) , or 800 mg ( n = 14 ) groups completed the study of quetiapine fumarate XR .
METHODS	The treatment phase consisted of 5 consecutive days and was preceded by a 1 - to 2-day titration period for the 600 and 800 mg groups .
METHODS	Pharmacokinetic parameters for both quetiapine and N-desalkyl quetiapine ( norquetiapine ) were determined .
METHODS	The tolerability evaluation included adverse events ( AEs ) noted by monitoring , physical examinations , vital signs , and clinical laboratory tests .
RESULTS	N-desalkyl quetiapine was formed from quetiapine with an approximate metabolite to parent ratio of 0.5 across the three dose groups .
RESULTS	The geometric mean elimination half-life ( t ) of both quetiapine and N-desalkyl quetiapine was consistent for the three dosing groups ( approximately 7 h for quetiapine and approximately 18 h for N-desalkyl quetiapine ) .
RESULTS	The geometric mean maximum plasma concentrations ( C max ) at steady state ( C max , ss ) of quetiapine for the three groups were 467 , 740 , and 1,126 ng/mL , respectively , and for N-desalkyl quetiapine were 138 , 262 , and 426 ng/mL , respectively .
RESULTS	The values for the geometric mean area under the plasma concentration-time curve over a dosing interval at the steady-state ( AUCss ) of quetiapine were 5,094 , 7,685 , and 13,237 ngh/mL , respectively , and for N-desalkyl quetiapine were 2,284 , 4,341 , and 7,216 ngh/mL , respectively .
RESULTS	The apparent oral clearance ( CL/F ) of quetiapine at steady state appeared to be comparable across the three dose groups .
RESULTS	The pharmacokinetics of quetiapine XR were dose-proportional across the dosage range employed .
RESULTS	The most common AE was somnolence , but all of the reported AEs were mild .
RESULTS	There were no serious AEs or other significant AEs .
CONCLUSIONS	Quetiapine fumarate XR has a dose-proportional pharmacokinetic profile at doses ranging from 300 to 800 mg once daily , and a slower time to reach C max and steady state after 3 days of sequential dosing .
CONCLUSIONS	Therefore , it offers a simple and rapid dose-escalation option and more convenient once-daily administration .
CONCLUSIONS	The three dosages of quetiapine fumarate XR were generally well-tolerated in this pharmacokinetic study of Han Chinese patients with schizophrenia .

###24289244
BACKGROUND	Although low-fluence 1064-nm Q-switched Nd : YAG laser ( QSNYL ) is widely used for the treatment of melasma , multiple treatments are necessary for clinical improvement .
BACKGROUND	Superficial chemical peeling using Jessner 's solution has been used for treatment of melasma conventionally .
OBJECTIVE	To evaluate the additional therapeutic effect and adverse effects of Jessner 's peel when combined with 1064-nm QSNYL for melasma patients in a double-blind , placebo-controlled design .
METHODS	Total of 52 patients were included .
METHODS	Patients who received 10 sessions of 1064-nm QSNYL plus chemical peeling with placebo ( group A ) in a two-week interval and those who received 10 sessions of 1064-nm QSNYL plus chemical peeling with Jessner 's solution ( group B ) in a two-week interval were analyzed .
METHODS	Responses were evaluated using the Melasma Area and Severity Index ( MASI ) score , physician 's global assessment ( PGA ) and subjective self-assessment .
RESULTS	At 8 weeks , the mean MASI score decreased from 8.684.06 to 8.603.88 in group A and from 8.983.72 to 7.132.57 in group B , showing a significant difference ( p < 0.001 ) .
RESULTS	But at 20 weeks , there was no significant difference on reduction of MASI , self-assessment and PGA between the two groups .
RESULTS	No serious adverse effects were reported with the additional Jessner 's peeling .
CONCLUSIONS	This study suggests Jessner 's peel is a safe and effective method in the early course of treatment for melasma when combined with low-fluence 1064-nm Q-switched Nd : YAG laser .

###25594166
OBJECTIVE	To evaluate the potential body weight-lowering effects of dietary supplementation with eicosapentaenoic acid ( EPA ) and - lipoic acid separately or combined in healthy overweight/obese women following a hypocaloric diet .
METHODS	This is a short-term double-blind placebo-controlled study with parallel design that lasted 10 weeks .
METHODS	Of the randomized participants , 97 women received the allocated treatment [ Control , EPA ( 1.3 g/d ) , - lipoic acid ( 0.3 g/d ) , and EPA + - lipoic acid ( 1.3 g/d +0.3 g/d ) ] , and 77 volunteers completed the study .
METHODS	All groups followed an energy-restricted diet of 30 % less than total energy expenditure .
METHODS	Body weight , anthropometric measurements , body composition , resting energy expenditure , blood pressure , serum glucose , and insulin and lipid profile , as well as leptin and ghrelin levels , were assessed at baseline and after nutritional intervention .
RESULTS	Body weight loss was significantly higher ( P < 0.05 ) in those groups supplemented with - lipoic acid .
RESULTS	EPA supplementation significantly attenuated ( P < 0.001 ) the decrease in leptin levels that occurs during weight loss .
RESULTS	Body weight loss improved lipid and glucose metabolism parameters but without significant differences between groups .
CONCLUSIONS	The intervention suggests that - lipoic acid supplementation alone or in combination with EPA may help to promote body weight loss in healthy overweight/obese women following energy-restricted diets .

###24614856
METHODS	Cross-sectional .
OBJECTIVE	To preliminarily evaluate the validity of an interview-based spinal cord injury ( SCI ) neuropathic pain screening instrument .
METHODS	Six university-based SCI centers in the United States .
METHODS	Clinician diagnoses of neuropathic pain ( NP ) and non-neuropathic pain subtypes were collected independently of descriptions of the pain characteristics provided by the persons with SCI by using the Spinal Cord Injury Pain Instrument ( SCIPI ) ; SCIPI information and physician diagnoses for 82 pain sites of which they were most confident were subsequently compared .
RESULTS	Four of the SCIPI items correlated significantly with the NP subtype as determined by the clinician .
RESULTS	The best cutoff score for identifying NP was an endorsement of two or more of these four items .
RESULTS	Using this cutoff , sensitivity of the SCIPI was 78 % , specificity was 73 % and overall diagnostic accuracy was 76 % .
CONCLUSIONS	In this preliminary study , the SCIPI , which can be administered by a nonclinician , appears to have good sensitivity , specificity and diagnostic accuracy in a SCI population ; it may have a role as a screening tool for NP after SCI .
CONCLUSIONS	Further study is needed .

###25409886
BACKGROUND	Stepped care is recommended and implemented as a means to organise depression treatment .
BACKGROUND	Compared with alternative systems , it is assumed to achieve equivalent clinical effects and greater efficiency .
BACKGROUND	However , no trials have examined these assumptions .
BACKGROUND	A fully powered trial of stepped care compared with intensive psychological therapy is required but a number of methodological and procedural uncertainties associated with the conduct of a large trial need to be addressed first .
METHODS	STEPS ( Developing stepped care treatment for depression ) is a mixed methods study to address uncertainties associated with a large-scale evaluation of stepped care compared with high-intensity psychological therapy alone for the treatment of depression .
METHODS	We will conduct a pilot randomised controlled trial with an embedded process study .
METHODS	Quantitative trial data on recruitment , retention and the pathway of patients through treatment will be used to assess feasibility .
METHODS	Outcome data on the effects of stepped care compared with high-intensity therapy alone will inform a sample size calculation for a definitive trial .
METHODS	Qualitative interviews will be undertaken to explore what people think of our trial methods and procedures and the stepped care intervention .
METHODS	A minimum of 60 patients with Major Depressive Disorder will be recruited from an Improving Access to Psychological Therapies service and randomly allocated to receive stepped care or intensive psychological therapy alone .
METHODS	All treatments will be delivered at clinic facilities within the University of Exeter .
METHODS	Quantitative patient-related data on depressive symptoms , worry and anxiety and quality of life will be collected at baseline and 6 months .
METHODS	The pilot trial and interviews will be undertaken concurrently .
METHODS	Quantitative and qualitative data will be analysed separately and then integrated .
CONCLUSIONS	The outcomes of this study will inform the design of a fully powered randomised controlled trial to evaluate the effectiveness and efficiency of stepped care .
CONCLUSIONS	Qualitative data on stepped care will be of immediate interest to patients , clinicians , service managers , policy makers and guideline developers .
CONCLUSIONS	A more informed understanding of the feasibility of a large trial will be obtained than would be possible from a purely quantitative ( or qualitative ) design .
BACKGROUND	Current Controlled Trials ISRCTN66346646 registered on 2 July 2014 .

###24359543
BACKGROUND	The overuse of antimicrobials is recognized as the main selective pressure driving the emergence and spread of antimicrobial resistance in human bacterial pathogens .
BACKGROUND	Urinary tract infections ( UTIs ) are among the most common infections presented in primary care and empirical antimicrobial treatment is currently recommended .
BACKGROUND	Previous research has identified that a substantial proportion of Irish general practitioners ( GPs ) prescribe antimicrobials for UTIs that are not in accordance with the Guidelines for Antimicrobial Prescribing in Primary Care in Ireland .
BACKGROUND	The aim of this trial is to design , implement and evaluate the effectiveness of a complex intervention on GP antimicrobial prescribing and adult ( 18 years of age and over ) patients ' antimicrobial consumption when presenting with a suspected UTI .
METHODS	The Supporting the Improvement and Management of Prescribing for urinary tract infections ( SIMPle ) study is a three-armed intervention with practice-level randomization .
METHODS	Adult patients presenting with suspected UTIs in primary care will be included in the study.The intervention integrates components for both GPs and patients .
METHODS	For GPs the intervention includes interactive workshops , audit and feedback reports and automated electronic prompts summarizing recommended first-line antimicrobial treatment and , for one intervention arm , a recommendation to consider delayed antimicrobial treatment .
METHODS	For patients , multimedia applications and information leaflets are included .
METHODS	Thirty practices will be recruited to the study ; laboratory data indicate that 2,038 patients will be prescribed an antimicrobial in the study .
METHODS	The primary outcome is a change in prescribing of first-line antimicrobials for UTIs in accordance with the Guidelines for Antimicrobial Prescribing in Primary Care in Ireland .
METHODS	The study will take place over 15 months with a six-month intervention period .
METHODS	Data will be collected through a remote electronic anonymized data-extraction system , a text-messaging system and GP and patient interviews and surveys .
METHODS	The intervention will be strengthened by the implementation of a social marketing framework and an economic evaluation .
BACKGROUND	This intervention is registered at ClinicalTrials.gov , ID NCT01913860 .

###25904734
BACKGROUND	Among young children in Burkina Faso , anemia and chronic and acute undernutrition are widespread .
OBJECTIVE	This study assessed the impact of Helen Keller International 's ( HKI ) 2-y integrated agriculture [ homestead food production ( HFP ) ] and nutrition and health behavior change communication ( BCC ) program , targeted to women , on children 's ( 3-12 .9 mo old at baseline ) anthropometry ( stunting , wasting , and underweight ) , mean hemoglobin ( Hb ) , anemia ( Hb < 11 g/dL ) , and diarrhea prevalence .
METHODS	We used a cluster-randomized controlled trial , with 55 villages randomly assigned to a control group ( n = 25 ) or 1 of 2 treatment groups ( n = 15 each ) , which differed by who delivered the BCC messages [ older women leaders or health committee ( HC ) members ] .
METHODS	We used difference-in-difference ( DID ) estimates to assess impacts on child outcomes .
RESULTS	We found marginally significant ( P < 0.10 ) impacts on Hb ( DID : 0.51 g/dL ; P = 0.07 ) and wasting [ DID : -8.8 percentage point ( pp ) ; P = 0.08 ] and statistically significant ( P < 0.05 ) impacts on diarrhea ( -15.9 pp ; P = 0.00 ) in HC compared with control villages among children aged 3-12 .9 mo and larger impacts for anemia ( DID : -14.6 pp ; P = 0.03 ) and mean Hb ( DID : 0.74 g/dL ; P = 0.03 ) among younger children ( aged 3-5 .9 mo ) .
RESULTS	However , we found no significant impacts on stunting or underweight prevalence .
RESULTS	Plausibility was supported by greater improvements in women 's agricultural production and maternal infant and young child feeding and care knowledge and practices in HC compared with control villages .
CONCLUSIONS	HKI 's 2-y integrated HFP+BCC program ( HC group ) significantly improved several child outcomes , including wasting ( marginal ) , diarrhea , Hb , and anemia , especially among the youngest children .
CONCLUSIONS	This is the first cluster-randomized controlled trial of an HFP program that documents statistically significant positive effects on these child nutrition outcomes .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01825226 .

###24812035
BACKGROUND	Occipital nerve stimulation ( ONS ) may provide pain relief in migraine patients .
BACKGROUND	In this double-blinded trial we investigated the significance of paresthesia and possible placebo effects .
METHODS	Patients already treated with ONS reporting stable treatment effect were included .
METHODS	`` Effective stimulation , '' `` subthreshold stimulation '' and `` no stimulation '' were compared .
METHODS	Patients cycled through all three treatment groups .
METHODS	Outcome was measured using the visual analog scale ( VAS ) for pain , McGill Pain Questionnaire and SF-36 .
RESULTS	Eight patients were included , mean preoperative VAS was 8.20 1.22 .
RESULTS	A significant improvement in pain was observed in favor of suprathreshold stimulation compared to subthreshold stimulation ( 1.98 1.56 vs 5.65 2.11 ) .
RESULTS	Pain also significantly improved under subthreshold stimulation compared to no stimulation ( 5.65 2.11 vs 8.45 0.99 ) .
RESULTS	No changes in SF-36 were observed .
CONCLUSIONS	Paresthesia is not required to achieve pain reduction but suprathreshold stimulation yields better results , underlining the significance of stimulation parameter customization .

###24949820
OBJECTIVE	To determine the relationship between delayed patchy choroidal filling and morphologic and functional outcomes among eyes treated with ranibizumab or bevacizumab .
METHODS	Cohort study .
METHODS	Comparison of Age-related Macular Degeneration Treatment Trials participants were assigned randomly to ranibizumab or bevacizumab on a monthly or as-needed schedule .
METHODS	Presence of delayed patchy choroidal filling and morphologic and functional outcomes were evaluated among eyes with gradable fluorescein angiography at baseline ( n = 973 ) and at 1 year ( n = 860 ) eyes .
RESULTS	Delayed filling was present in 75 ( 7.7 % ) of 973 eyes at baseline .
RESULTS	Eyes with incident delayed filling at 1 year ( 23 [ 2.9 % ] of 798 ) showed a mean decrease of 1.7 letters in visual acuity , whereas eyes without incident delayed filling had a mean improvement of 8.1 letters ( difference [ ] , -9.8 ; 95 % confidence interval [ CI ] , -15.8 to -3.9 ; P < .01 ) .
RESULTS	Eyes with incident delayed filling had a larger increase in mean total lesion area of choroidal neovascularization ( 3.00 mm ( 2 ) ) than eyes without incident delayed filling ( 0.56 mm ( 2 ) ; , 2.4 ; 95 % CI , 0.4 to 4.4 ; P = .02 ) .
RESULTS	The proportion with incident delayed filling at 1 year was similar among eyes treated with ranibizumab ( 10 [ 2.4 % ] of 413 ) or bevacizumab ( 13 [ 3.3 % ] of 385 ; P = .53 ) and among eyes treated monthly ( 12 [ 3.1 % ] of 388 ) or as needed ( 11 [ 2.7 % ] of 410 ; P = .83 ) .
CONCLUSIONS	Delayed patchy choroidal filling was uncommon at baseline .
CONCLUSIONS	Although only a small percentage of eyes demonstrated delayed filling during the first year of anti-vascular endothelial growth factor treatment , these eyes had worse visual acuity and a larger increase in total lesion area of choroidal neovascularization .

###26200980
BACKGROUND	AVI-7288 is a phosphorodiamidate morpholino oligomer with positive charges that targets the viral messenger RNA that encodes Marburg virus ( MARV ) nucleoprotein .
BACKGROUND	Its safety in humans is undetermined .
METHODS	We assessed the efficacy of AVI-7288 in a series of studies involving a lethal challenge with MARV in nonhuman primates .
METHODS	The safety of AVI-7288 was evaluated in a randomized , multiple-ascending-dose study in which 40 healthy humans ( 8 humans per dose group ) received 14 once-daily infusions of AVI-7288 ( 1 mg , 4 mg , 8 mg , 12 mg , or 16 mg per kilogram of body weight ) or placebo , in a 3:1 ratio .
METHODS	We estimated the protective dose in humans by comparing pharmacokinetic variables in infected nonhuman primates , uninfected nonhuman primates , and uninfected humans .
RESULTS	Survival in infected nonhuman primates was dose-dependent , with survival rates of 0 % , 30 % , 59 % , 87 % , 100 % , and 100 % among monkeys treated with 0 mg , 3.75 mg , 7.5 mg , 15 mg , 20 mg , and 30 mg of AVI-7288 per kilogram , respectively ( P < 0.001 with the use of the log-rank test for the comparison of survival across groups ) .
RESULTS	No safety concern was identified at doses up to 16 mg per kilogram per day in humans .
RESULTS	No serious adverse events were reported .
RESULTS	Drug exposure ( the area under the curve ) was dose-dependent in both nonhuman primates and humans ; drug clearance was independent of dose but was higher in nonhuman primates than in humans .
RESULTS	The protective dose in humans was initially estimated , on the basis of exposure , to be 9.6 mg per kilogram per day ( 95 % confidence interval , 6.6 to 12.5 ) for 14 days .
RESULTS	Monte Carlo simulations supported a dose of 11 mg per kilogram per day to match the geometric mean protective exposure in nonhuman primates .
CONCLUSIONS	This study shows that , on the basis of efficacy in nonhuman primates and pharmacokinetic data in humans , AVI-7288 has potential as postexposure prophylaxis for MARV infection in humans .
CONCLUSIONS	( Funded by the Department of Defense ; ClinicalTrials.gov number , NCT01566877 . )

###24980886
OBJECTIVE	Better understanding of the circumstances of alcohol-related adverse events experienced by university students could identify opportunities for prevention .
OBJECTIVE	We aimed to identify situational and contextual factors associated with unintentional injury , assault , unsafe sex , sexual assault and drink-driving/riding amongst university students .
METHODS	We conducted a Web-based survey of full-time students aged 17-25 years at five New Zealand universities ( n = 2683 ) and carried out between - and within-subjects comparisons ( case-control and case-crossover , respectively ) of situational and contextual characteristics of events in the last seven days and control drinking occasions .
RESULTS	The response fraction was 49 % .
RESULTS	For the seven days preceding the survey , 4.9 % of women and 7.4 % of men reported at least one of the defined events while they were drinking or soon after .
RESULTS	The number of drinking locations and getting drunker than expected were strongly associated with risk of an event in both case-control and case-crossover models , independent of consumption .
RESULTS	Total number of drinks , drinking later and into the morning , and drinking with close friends were also associated with increased risk in the case-control analysis .
RESULTS	No gender difference was seen after controlling for drinking and contextual factors .
CONCLUSIONS	Strategies to reduce the duration and volume of alcohol consumption , including earlier closing of licensed premises , should be considered as countermeasures for alcohol-related adverse events .
CONCLUSIONS	The use of two different comparison groups for the circumstances of adverse events when drinking can strengthen inferences about the contribution of contextual factors .

###24366725
BACKGROUND	While the 2-adrenoceptor pathway is essential for cardiovascular regulation , the impact of ADRB2 gene variations on circulatory responses is unclear , possibly due to neural compensatory mechanisms .
BACKGROUND	We tested the hypotheses that ( i ) sympathetic block by thoracic epidural anaesthesia ( TEA ) unmasks the influence on arterial pressure of genetic variations and ( ii ) vasopressor requirements during TEA depend on ADRB2 gene variation .
METHODS	Ninety-three elective patients undergoing abdominal surgery were included prospectively .
METHODS	After epidural bupivacaine 0.5 % ( 15 mg test dose +50 mg ) , arterial pressure , heart rate , and progression of sensory block were measured for 20 min in the supine awake state and for 20 min after standardized anaesthetic induction of general anaesthesia .
METHODS	The primary endpoint was cumulative dose of the - adrenoreceptor agonist phenylephrine administered to sustain a mean arterial pressure > 70 mm Hg .
METHODS	The ADRB2 polymorphisms Arg16Gly and Gln27Glu were genotyped using Slowdown-PCR .
RESULTS	After TEA , 86 ( 93 % ) patients required phenylephrine .
RESULTS	The mean dosages ( sd ) were significantly different between the ADRB2 genotypes [ Arg16Arg 357 g ( 326 ) , Arg16Gly 776 g ( 449 ) , Gly16Gly 600 g ( 443 ) , P = 0.036 ; Gln27Gln 356 g ( 254 ) , Gln27Glu 639 g ( 354 ) , Glu27Glu 577 g ( 388 ) , P = 0.007 ] .
RESULTS	Multiple linear regression analysis revealed that age , male gender , rostral extent of sensory block , lower arterial pressure before TEA , and ADRB2 Glu27 allele together explained 37 % of phenylephrine dosage variation , with genetic variants being the second most important predictor ( 10 % ; P < 0.001 ) .
CONCLUSIONS	The ADRB2 Glu27 allele is an independent predictor of arterial hypotension and vasopressor requirements after TEA .
CONCLUSIONS	Neural block can unmask genetic influences on neurohumoral regulation .
CONCLUSIONS	Clinical trial registration DRKS00005260 .

###25928427
BACKGROUND	Patient-centered models of assessment have shown considerable promise for increasing patients ' readiness for mental health treatment in general , but have not been used to facilitate patients ' engagement in substance use disorder ( SUD ) treatment .
BACKGROUND	We developed a brief patient-centered intervention using assessment and feedback of personality data and examined its acceptability and efficacy to increase early engagement in residential SUD treatment .
METHODS	Thirty patients entering a 90-day residential SUD treatment program were randomly assigned to a feedback ( n = 17 ) or control ( n = 13 ; assessment-only ) condition .
METHODS	Normal-range personality was assessed with the NEO Personality Inventory-Revised ( NEO PI-R ) .
METHODS	Patients were re-interviewed one month after treatment entry to obtain information on their satisfaction with the intervention , as well as their adjustment to the residential milieu .
METHODS	Electronic medical records were reviewed to obtain information on patients ' length of stay in the program and discharge status .
METHODS	Univariate ANOVAs and chi-square tests were conducted to examine group differences on outcomes .
RESULTS	Patients ' ratings indicated strong satisfaction with the feedback intervention and expectations that it would have a positive impact on their treatment experiences .
RESULTS	Among patients who had not previously been treated in the residential program , the feedback intervention was associated with more positive relationships with other residents in treatment and a stronger alliance with the treatment program one month after treatment entry .
RESULTS	The feedback intervention was also associated with a longer length of stay in treatment , although this effect did not reach statistical significance .
CONCLUSIONS	The findings highlight the clinical utility of providing SUD patients with patient-centered feedback based on the results of personality testing , and provide preliminary support for the acceptability and efficacy of this intervention to facilitate early engagement in residential SUD treatment .

###25440099
BACKGROUND	In children with single right ventricular ( RV ) anomalies , changes in RV size and function may beinfluenced by shunt type chosen at the time of the Norwood procedure .
OBJECTIVE	The study sought to identify shunt-related differences in echocardiographic findings at 14 months and6months pre-Fontan in survivors of the Norwood procedure .
METHODS	We compared 2-dimensional and Doppler echocardiographic indices of RV size and function , neo-aortic and tricuspid valve annulus dimensions and function , and aortic size and patency at 14.1 1.2 months and 33.6 9.6 months in subjects randomized to a Norwood procedure using either the modified Blalock-Taussig shunt ( MBTS ) or right ventricle to pulmonary artery shunt ( RVPAS ) .
RESULTS	Acceptable echocardiograms were available at both time points in 240 subjects ( 114 MBTS , 126 RVPAS ) .
RESULTS	At 14 months , all indices were similar between shunt groups .
RESULTS	From the 14-month to pre-Fontan echocardiogram , the MBTS group had stable indexed RV volumes and ejection fraction , while the RVPAS group had increased RV end-systolic volume ( p = 0.004 ) and decreased right ventricular ejection fraction ( RVEF ) ( p = 0.004 ) .
RESULTS	From 14 months to pre-Fontan , the treatment groups were similar with respect to decline in indexed neo-aortic valve area , > mild neo-aortic valve regurgitation ( < 5 % at each time ) , indexed tricuspid valve area , andmoderate tricuspid valve regurgitation ( < 20 % at each time ) .
CONCLUSIONS	Initial Norwood shunt type influences pre-Fontan RV remodeling during the second and third years of life in survivors with single RV anomalies , with greater RVEF deterioration after RVPAS .
CONCLUSIONS	Encouragingly , other indices of RV function remain stable before Fontan regardless of shunt type .
CONCLUSIONS	( Comparison of Two Types of Shunts in Infants with Single Ventricle Defect Undergoing Staged Reconstruction-Pediatric Heart Network ; NCT00115934 ) .

###25034330
OBJECTIVE	The aim of the study was to compare Cistiquer , a new phytotherapeutic product developed for chronic bladder inflammatory diseases , and intra-vesical administration of gentamicin plus betametasone , in females with urethral syndrome .
METHODS	Between september 2013 and may 2014 , 60 women with urethral syndrome and trigonitis were incuded in this study .
METHODS	Patients were randomly assigned to treatment with intra-vesical administration of betametasone 8 mg plus gentamicin 80 mg ( group A ) , and oral administration of Cistiquer ( group B ) for 7 weeks .
METHODS	Before and after the therapeutic protocol , symptoms were assessed by three days voiding diary , the overactive bladder questionnaire short form and a ten points visual analogic scale adopted to assess the micturition discomfort .
METHODS	Histologic findings were assessed by the examination of specimens obtained by cold bladder biopsies of the bladder trigone at baseline in all the subjects .
RESULTS	The two groups had significant and comparable symptoms improvement .
RESULTS	However , the score obtained from the visual analogic scale decreased significantly only in the group submitted to oral therapy .
RESULTS	Furthermore , in the group treated with endovesical approach , higher drop out rate and higher incidence of urinary infection were observed .
CONCLUSIONS	Patients with urethral syndrome and trigonitis improved symptoms either with oral therapy with Cistiquer and with intra-vesical administration of gentamicin plus betametasone .
CONCLUSIONS	However , treatment adherence resulted higher for patients treated by oral therapy and rate of adverse events resulted higher for those submitted to endovesical treatment .

###24962038
OBJECTIVE	To evaluate the cardiorespiratory , sedative and antinociceptive effects of dexmedetomidine alone or in combination with methadone , morphine or tramadol in dogs .
METHODS	Experimental , blinded , randomized , crossover study .
METHODS	Six mixed breed dogs ( two males and four females ) weighing 10 4 kg .
METHODS	The animals were randomly divided into four treatments : D ( 10 g kg ( -1 ) of dexmedetomidine ) , DM ( dexmedetomidine 10 g kg ( -1 ) and methadone 0.5 mg kg ( -1 ) ) ; DMO ( dexmedetomidine 10 g kg ( -1 ) and morphine 0.5 mg kg ( -1 ) ) , and DT ( dexmedetomidine 10 g kg ( -1 ) and tramadol 2 mg kg ( -1 ) ) .
METHODS	The combinations were administered intramuscularly in all treatments .
METHODS	The variables evaluated were heart rate ( HR ) , respiratory rate ( f ( R ) ) , rectal temperature ( RT ) , systolic arterial pressure ( SAP ) , sedation scale and pedal withdrawal reflex .
METHODS	These variables were measured at T0 ( immediately before the administration of the protocol ) and every 15 minutes thereafter until T105 .
RESULTS	A decrease in HR and f ( R ) occurred in all the treatments compared with T0 , but no significant difference was observed between the treatments .
RESULTS	The RT decreased from T45 onward in all the treatments .
RESULTS	The SAP did not show a difference between the treatments , but in the DT treatment , the SAP was lower at T30 and T45 compared with T0 .
RESULTS	The D treatment had lower scores of sedation at T15 to T75 compared with the other treatments , and the DMO and DM treatments showed higher scores at T60 and T75 compared with DT .
CONCLUSIONS	The treatments with morphine and methadone added to the dexmedetomidine showed higher sedation scores than the control treatment and the treatment with tramadol added to the dexmedetomidine showed no relevant differences in any of the variables evaluated in the study .

###24576381
OBJECTIVE	This study was conducted to examine the effects of aerobic exercise training on psychosocial aspects ( mental health , the aspects of physical symptoms , anxiety and insomnia , social functioning , and depression ) in patients with type 2 diabetes mellitus .
METHODS	53 men who had type 2 diabetes mellitus for a mean duration of the disease for 35 years were selected purposely and classified randomly into experimental ( 27 patients ) and a control group ( 26 patients ) .
METHODS	Patients in the experimental group did aerobic exercise training three times a week for eight weeks .
METHODS	The exercise included an aerobic activity for 45 to 60 minutes during which the patients ' heart rates were maintained at 60-70 percent of heart rate reserve on ergo meter bikes .
RESULTS	The eight-week aerobic exercise training had significant effects on mental health ( p = 0.002 ) , subscales of physical symptoms ( p = 0.006 ) , and anxiety and insomnia ( p = 0.001 ) .
RESULTS	It had no significant effects on subscales related to disorder of social functioning ( p = 0.117 ) and depression ( p = 0.657 ) .
CONCLUSIONS	Aerobic exercise training can be considered as an appropriate program for improving the health of the patients with type 2 diabetes mellitus , and it also can improve their mental health .

###24885374
BACKGROUND	The Whitehall II ( WHII ) study of British civil servants provides a unique source of longitudinal data to investigate key factors hypothesized to affect brain health and cognitive ageing .
BACKGROUND	This paper introduces the multi-modal magnetic resonance imaging ( MRI ) protocol and cognitive assessment designed to investigate brain health in a random sample of 800 members of the WHII study .
METHODS	A total of 6035 civil servants participated in the WHII Phase 11 clinical examination in 2012-2013 .
METHODS	A random sample of these participants was included in a sub-study comprising an MRI brain scan , a detailed clinical and cognitive assessment , and collection of blood and buccal mucosal samples for the characterisation of immune function and associated measures .
METHODS	Data collection for this sub-study started in 2012 and will be completed by 2016 .
METHODS	The participants , for whom social and health records have been collected since 1985 , were between 60-85 years of age at the time the MRI study started .
METHODS	Here , we describe the pre-specified clinical and cognitive assessment protocols , the state-of-the-art MRI sequences and latest pipelines for analyses of this sub-study .
CONCLUSIONS	The integration of cutting-edge MRI techniques , clinical and cognitive tests in combination with retrospective data on social , behavioural and biological variables during the preceding 25years from a well-established longitudinal epidemiological study ( WHII cohort ) will provide a unique opportunity to examine brain structure and function in relation to age-related diseases and the modifiable and non-modifiable factors affecting resilience against and vulnerability to adverse brain changes .

###24651386
BACKGROUND	Results from the National Lung Cancer Audit demonstrate unexplained variation in outcomes .
BACKGROUND	Peer review with supported quality improvement has been shown to reduce variation in other areas of health care but has not been formally tested in cancer multidisciplinary teams .
BACKGROUND	The aim of the current study is to assess the impact of reciprocal peer-to-peer review visits with supported quality improvement and collaborative working on lung cancer process and outcome measures .
METHODS	English lung cancer teams were randomised to usual care or facilitated reciprocal peer review visits followed by 12 months of supported quality improvement .
METHODS	The primary outcome was change in the following national audit indicators ; mulitdisciplinary team discussion , histological confirmation , active treatment , surgical resection , small-cell chemotherapy and specialist nurse review .
METHODS	Patient experience was measured using a new lung cancer patient questionnaire in the intervention group .
RESULTS	Thirty teams ( 31 trusts ) entered the intervention group and 29 of these submitted a total of 67 quality improvement plans .
RESULTS	Active treatment increased in the intervention group ( n = 31 ) by 5.2 % compared with 1.2 % in the control group ( n = 48 , mean difference 4.1 % , 95 % CI -0.1 to 8.2 % , P = 0.055 ) .
RESULTS	The remaining audit indicators improved similarly in all groups .
RESULTS	Mean patient experience scores in the intervention group did not change significantly during the study but a significant improvement was seen in the scores for the five teams with the worst baseline scores ( 0.86 to 0.22 , P < 0.001 ) .
CONCLUSIONS	Reciprocal peer review with supported quality improvement was feasible and effective in stimulating quality improvement activity but resulted in only modest improvements in lung cancer treatment rates and patient experience .

###24370208
BACKGROUND	Chronic fatigue syndrome or myalgic encephalomyelitis ( CFS/ME ) is a relatively common and potentially serious condition with a limited evidence base for treatment .
BACKGROUND	Specialist treatment for paediatric CFS/ME uses interventions recommended by National Institute for Health and Clinical Excellence ( NICE ) including cognitive behavioural therapy , graded exercise therapy and activity management .
BACKGROUND	The Lightning Process ( LP ) is a trademarked intervention derived from osteopathy , life-coaching and neuro-linguistic programming , delivered over three consecutive days as group sessions .
BACKGROUND	Although over 250 children with CFS/ME attend LP courses each year , there are no reported studies on the effectiveness or cost-effectiveness .
METHODS	This pragmatic randomised controlled trial is set within a specialist paediatric CFS/ME service in the south west of England .
METHODS	Children and young people with CFS/ME ( n = 80 to 112 ) , aged 12 to 18 years old will be randomised to specialist medical care ( SMC ) or SMC plus the LP .
METHODS	The primary outcome will be physical function ( SF-36 physical function short form ) and fatigue ( Chalder Fatigue Scale ) .
CONCLUSIONS	This study will tell us whether adding the LP to SMC is effective and cost-effective compared to SMC alone .
CONCLUSIONS	This study will also provide detailed information on the implementation of the LP and SMC .
BACKGROUND	Current Controlled Trials ISRCTN81456207 ( 31 July 2012 ) .

###25041326
OBJECTIVE	The study was designed to evaluate the effectiveness of the combination of chemonucleolysis and psoas compartment block ( PCB ) for the treatment of lumbar disc herniations ( LDHs ) and to explore the role of PCB in managing postoperative pain of collagenase injection .
METHODS	Two groups of patients ( N = 192 ) were treated in different ways , respectively .
METHODS	Group A ( N = 95 ) was treated with chemonucleolysis only ( the injection of oxygen-ozone combined with collagenase into the lumbar disc and the epidural space ) ; group B ( N = 97 ) was treated with chemonucleolysis and PCB .
METHODS	After the treatment , the patients were followed-up , and the therapeutic effect was assessed at 1 week , 1 month , 3 months , and 6 months by the relative pain reduction , visual analog scale ( VAS ) pain scores , and the Oswestry Disability Index ( ODI ) scores .
RESULTS	In group A , treatment success rate was 64.2 % ( 61 of 95 ) , 82.1 % ( 78 of 95 ) , 84.2 % ( 80 of 95 ) , and 86.3 % ( 82 of 95 ) at 1 week , 1 month , 3 months , and 6 months , respectively .
RESULTS	In group B , treatment success rate was 86.5 % ( 84 of 97 ) , 89.6 % ( 87 of 97 ) , 93.8 % ( 91 of 97 ) , and 91.7 % ( 89 of 97 ) at 1 week , 1 month , 3 months , and 6 months , respectively .
RESULTS	There was statistically significant difference in outcome between two groups at 1 week , but there were no statistically significant difference in outcome between two groups at 1 month , 3 months , and 6 months .
RESULTS	VAS scores and ODI were significantly decreased in both group A and group B , when compared with the baseline values in the same group at all points of follow-up .
RESULTS	Group B produced a significant reduction in the VAS scores and ODI when compared with group A at : 1-week , 1-month , 3-month , 6-month follow-up .
CONCLUSIONS	Computer tomography ( CT ) - guided chemonucleolysis combined with PCB leads to rapid pain relief , fewer postoperative pain of collagenase injection happen , and should be regarded as a useful treatment for the management of LDH .

###25516022
OBJECTIVE	To identify patient and caregiver characteristics associated with caregiver dissatisfaction with hospital care of cognitively impaired elderly adults .
METHODS	Secondary analysis of data from a randomized controlled trial .
METHODS	An 1,800-bed general hospital in England providing the only emergency medical services in its area .
METHODS	Cognitively impaired individuals aged 65 and older randomly assigned to a specialist unit or standard geriatric or internal medical wards ( N = 600 ) and related caregivers ( N = 488 ) .
METHODS	Patient and caregiver health status was measured at baseline , including delirium , cognitive impairment , behavioral and psychological symptoms , activities of daily living , and caregiver strain .
METHODS	Caregiver satisfaction with quality of care was ascertained after hospital discharge or death .
RESULTS	Four hundred sixty-two caregivers completed satisfaction questionnaires .
RESULTS	Regardless of assignment , 54 % of caregivers were dissatisfied with some aspects of care , but overall 87 % were satisfied with care .
RESULTS	The main areas of dissatisfaction were communication , discharge planning , and medical management .
RESULTS	Dissatisfaction was associated with high levels of patient behavioral and psychological symptoms on admission , caregiver strain and poor psychological well-being at admission , a diagnosis of delirium , and the relationship between the caregiver and the patient .
RESULTS	There was less dissatisfaction from caregivers of patients managed on the specialist Medical and Mental Health Unit than those on standard wards , after controlling for multiple factors .
CONCLUSIONS	Dissatisfaction was associated with patient behavioral and psychological symptoms and caregiver strain but was not immutable to efforts to improve care .

###24253250
BACKGROUND	Statins , or 3-hydroxy-3-methylglutaryl coenzyme A ( HMG-CoA ) reductase inhibitors , have anti-inflammatory effects that are independent of their lipid-lowering properties .
BACKGROUND	Despite suppressive antiretroviral therapy ( ART ) , elevated levels of immune activation and inflammation often persist .
METHODS	The Stopping Atherosclerosis and Treating Unhealthy Bone With Rosuvastatin in HIV ( SATURN-HIV ) trial is a randomized , double-blind , placebo-controlled study , designed to investigate the effects of rosuvastatin ( 10 mg/daily ) on markers of cardiovascular disease risk in ART-treated human immunodeficiency virus ( HIV ) - infected subjects .
METHODS	A preplanned analysis was to assess changes in markers of immune activation at week 24 .
METHODS	Subjects with low-density lipoprotein cholesterol < 130 mg/dL and heightened immune activation ( % CD8 ( + ) CD38 ( + ) HLA-DR ( + ) 19 % , or plasma high-sensitivity C-reactive protein 2 mg/L ) were randomized to receive rosuvastatin or placebo .
METHODS	We measured plasma ( soluble CD14 and CD163 ) and cellular markers of monocyte activation ( proportions of monocyte subsets and tissue factor expression ) and T-cell activation ( expression of CD38 , HLA-DR , and PD1 ) .
RESULTS	After 24 weeks of rosuvastatin , we found significant decreases in plasma levels of soluble CD14 ( -13.4 % vs 1.2 % , P = .002 ) and in proportions of tissue factor-positive patrolling ( CD14 ( Dim ) CD16 ( + ) ) monocytes ( -38.8 % vs -11.9 % , P = .04 ) in rosuvastatin-treated vs placebo-treated subjects .
RESULTS	These findings were independent of the lipid-lowering effect and the use of protease inhibitors .
RESULTS	Rosuvastatin did not lead to any changes in levels of T-cell activation .
CONCLUSIONS	Rosuvastatin treatment effectively lowered markers of monocyte activation in HIV-infected subjects on antiretroviral therapy .
BACKGROUND	NCT01218802 .

###26437498
OBJECTIVE	To compare the efficacy of an anhydrous dentifrice containing 0.454 % w/w stannous fluoride and a negative control dentifrice containing 1,000 ppm fluoride , as sodium monofluorophosphate , at reducing dentin hypersensitivity over 8 weeks with twice-daily brushing .
METHODS	This was a randomized , examiner-blind , parallel , two treatment group , stratified ( by maximum baseline Schiff sensitivity score ) , 8-week clinical study carried out at a single site in 119 healthy subjects with at least two sensitive teeth , who met all study criteria at the screening and baseline visits .
METHODS	Clinical assessments of sensitivity to evaporative ( air ) [ with Schiff sensitivity score and visual analogue scale ( VAS ) ] and tactile ( Yeaple probe ) stimuli were employed to compare the efficacy of the test dentifrice containing 0.454 % w/w stannous fluoride to the negative control dentifrice at reducing sensitivity after 4 and 8 weeks treatment .
RESULTS	Of the 119 subjects randomized to study treatment , 113 completed the study .
RESULTS	At 4 and 8 weeks , between treatment analyses found the test dentifrice to be significantly better than the negative control dentifrice in relieving dentin hypersensitivity for all measures ( Schiff : P < 0.0001 at 4 and 8 weeks ; VAS score : P = 0.0003 at 4 weeks , P < 0.0001 at 8 weeks ; tactile threshold : P = 0.0138 at 4 weeks , P < 0.0001 at 8 weeks ) .

###24779241
OBJECTIVE	To discuss the influence of mifepristone to caspase 3 expression in adenomyosis tissue .
METHODS	Sixty patients were equally divided into four groups .
METHODS	Groups 1 , 2 , and 3 were treated with 5 , 10 , and 15 mg mifepristone , respectively and group 4 was treated with placebo .
METHODS	The expression of caspase 3 was examined by immunohistochemical method in both eutopic and ectopic endometria of the 40 cases .
RESULTS	Compared with placebo group , the expression of caspase 3 in both eutopic endometrium and ectopic endometrium in the three treatment groups was significantly increased .
RESULTS	There was no difference in the expression of caspase 3 in both eutopic and ectopic endometria between the ten and 25 mg treatment groups , while both the ten and 25 mg treatment groups had a higher expression intensity of caspase 3 in both eutopic and ectopic endometria , compared with the five mg treatment group ( p < 0.01 ) .
CONCLUSIONS	Mifepristone can increase the expression of caspase 3 in both eutopic and ectopic endometria and initiate cell apoptosis in both eutopic and ectopic endometria .
CONCLUSIONS	Therefore mifepristone can effectively inhibit the emergence and development of adenomyosis .

###25345840
OBJECTIVE	The aim of this study was to evaluate the efficacy and safety of intralesional bevacizumab , a monoclonal antibody against vascular endothelial growth factor , in patients with human immunodeficiency virus ( HIV ) - associated Kaposi 's sarcoma of the upper airway receiving antiretroviral therapy .
METHODS	A pilot randomized , open , phase II study .
METHODS	HIV-infected patients with Kaposi 's sarcoma lesions of the upper airway in the T0 stage were randomized to receive antiretroviral therapy alone or antiretroviral therapy with intralesional bevacizumab .
METHODS	The primary end point was the assessment of changes in tumor size according to the Response Evaluation Criteria In Solid Tumors ( RECIST ) ; the secondary end point was safety .
RESULTS	Of the 14 patients with Kaposi 's sarcoma included in the study , seven were assigned to the bevacizumab group and seven to the control group .
RESULTS	The median age was 30.5 years ( interquartile range [ IQR ] , 24.7-38 .2 ) .
RESULTS	Four patients ( 28.5 % ) had > 150 CD4 T cells/mm ( 3 ) .
RESULTS	Nine patients had lesions in the oral cavity ; three patients had pharyngeal disease ; one patient had laryngeal involvement ; and one patient had oral cavity , pharyngeal , and laryngeal involvement .
RESULTS	Four patients had complete response ( 28.5 % ) , two had partial response , six had stable disease , and two had progressive disease .
RESULTS	The median time to complete response was 13 weeks ( IQR , 7.5-36 .5 ) .
RESULTS	No statistical differences between groups were observed ( P = .124 ) .
RESULTS	In the bevacizumab group , one patient had a grade I adverse event , and another patient had a grade II adverse event .
CONCLUSIONS	Intralesional administration of bevacizumab was well tolerated but had no impact on upper respiratory tract Kaposi 's sarcoma lesions of HIV-infected patients .

###24260137
BACKGROUND	U.S. state AIDS Drug Assistance Programs ( ADAPs ) are federally funded to provide antiretroviral therapy ( ART ) as the payer of last resort to eligible persons with HIV infection .
BACKGROUND	States differ regarding their financial contributions to and ways of implementing these programs , and it remains unclear how this interstate variability affects HIV treatment outcomes .
METHODS	We analyzed data from HIV-infected individuals who were clinically-eligible for ART between 2001 and 2009 ( i.e. , a first reported CD4 + < 350 cells/uL or AIDS-defining illness ) from 14 U.S. cohorts of the North American AIDS Cohort Collaboration on Research and Design ( NA-ACCORD ) .
METHODS	Using propensity score matching and Cox regression , we assessed ART initiation ( within 6 months following eligibility ) and virologic suppression ( within 1 year ) based on differences in two state ADAP features : the amount of state funding in annual ADAP budgets and the implementation of waiting lists .
METHODS	We performed an a priori subgroup analysis in persons with a history of injection drug use ( IDU ) .
RESULTS	Among 8,874 persons , 56 % initiated ART within six months following eligibility .
RESULTS	Persons living in states with no additional state contribution to the ADAP budget initiated ART on a less timely basis ( hazard ratio [ HR ] 0.73 , 95 % CI 0.60-0 .88 ) .
RESULTS	Living in a state with an ADAP waiting list was not associated with less timely initiation ( HR 1.12 , 95 % CI 0.87-1 .45 ) .
RESULTS	Neither additional state contributions nor waiting lists were significantly associated with virologic suppression .
RESULTS	Persons with an IDU history initiated ART on a less timely basis ( HR 0.67 , 95 % CI 0.47-0 .95 ) .
CONCLUSIONS	We found that living in states that did not contribute additionally to the ADAP budget was associated with delayed ART initiation when treatment was clinically indicated .
CONCLUSIONS	Given the changing healthcare environment , continued assessment of the role of ADAPs and their features that facilitate prompt treatment is needed .

###25858239
OBJECTIVE	Randomized trials have indicated a benefit for endovascular therapy in appropriately selected stroke patients at 3 months , but data regarding outcomes at 12 months are currently lacking .
METHODS	We compared functional and quality-of-life outcomes at 12 months overall and by stroke severity in stroke patients treated with intravenous tissue-type plasminogen activator followed by endovascular treatment as compared with intravenous tissue-type plasminogen activator alone in the Interventional Management of Stroke III Trial .
METHODS	The key outcome measures were a modified Rankin Scale score 2 ( functional independence ) and the Euro-QoL EQ-5D , a health-related quality-of-life measure .
RESULTS	656 subjects with moderate-to-severe stroke ( National Institutes of Health Stroke Scale 8 ) were enrolled at 58 centers in the United States ( 41 sites ) , Canada ( 7 ) , Australia ( 4 ) , and Europe ( 6 ) .
RESULTS	There was an interaction between treatment group and stroke severity in the repeated measures analysis of modified Rankin Scale 2 outcome ( P = 0.039 ) .
RESULTS	In the 204 participants with severe stroke ( National Institutes of Health Stroke Scale 20 ) , a greater proportion of the endovascular group had a modified Rankin Scale 2 ( 32.5 % ) at 12 months as compared with the intravenous tissue-type plasminogen activator group ( 18.6 % , P = 0.037 ) ; no difference was seen for the 452 participants with moderately severe strokes ( 55.6 % versus 57.7 % ) .
RESULTS	In participants with severe stroke , the endovascular group had 35.2 ( 95 % confidence interval : 2.1 , 73.3 ) more quality-adjusted-days over 12 months as compared with intravenous tissue-type plasminogen activator alone .
CONCLUSIONS	Endovascular therapy improves functional outcome and health-related quality-of-life at 12 months after severe ischemic stroke .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00359424 .

###24853043
BACKGROUND	In a recent double-blinded clinical trial , the probiotic combination of Lactobacillus acidophilus NCFM ( L-NCFM ) and B-LBi07 reduced bloating symptoms in patients with functional bowel disorders ; an effect more evident in those who reported abdominal pain .
BACKGROUND	In mice , L-NCFM but not B-LBi07 induced colonic mu-opioid receptor ( MOR ) and cannabinoid receptor 2 ( CB2 ) expression , and reduced visceral sensitivity .
OBJECTIVE	To determine if L-NCFM was the active component in the clinical trial and to investigate the mechanism of action in humans with mild to moderate abdominal pain .
METHODS	Caucasian women ( n = 20 ) 18-70 years with mild to moderate abdominal pain were enrolled in a double-blind , two-armed , single-centre study .
METHODS	Patients were given either L-NCFM alone or in combination with B-LBi07 for 21 days at a total dose of 2 10 ( 10 ) CFU b.d. Colonic biopsies were collected during unsedated , unprepped flexible sigmoidoscopy before and at the end of probiotic consumption .
METHODS	mRNA and immunostaining were then performed on these biopsies .
METHODS	Patients kept symptom diaries for the 7 days prior to starting probiotic therapy and for the last 7 days of therapy .
RESULTS	L-NCFM alone , but not with B-LBi07 , induced colonic MOR mRNA and protein expression , as well as downstream signalling , as measured by enterocyte STAT3-phosphorylation .
RESULTS	In contrast , CB2 expression was decreased .
RESULTS	Both treatment groups trended towards improvement in symptoms , but the study was insufficiently powered to draw meaningful conclusions .
CONCLUSIONS	Lactobacillus acidophilus NCFM modulates mu-opioid receptor expression and activity , while the combination of L-NCFM and B-LBi07 does not .
CONCLUSIONS	This study provides a possible mechanism for action by which probiotics modulates pain sensation in humans ( Clinical Trial Number : NCT01064661 ) .

###25131735
BACKGROUND	In Guinea-Bissau we conducted three trials of neonatal vitamin A supplementation ( NVAS ) from 2002 to 2008 .
BACKGROUND	None of the trials found a beneficial effect on mortality .
BACKGROUND	From 2003 to 2007 , an early measles vaccine ( MV ) trial was ongoing , randomizing children 1:2 to early MV at 4.5 months or no early MV , in addition to the usual MV at 9 months .
BACKGROUND	We have previously found interactions between vitamin A and vaccines .
OBJECTIVE	We investigated whether there were interactions between NVAS and early MV .
METHODS	We compared the mortality of NVAS and placebo recipients : first , from 4.5 to 8 months for children randomized to early MV or no early MV ; and second , from 9 to 17 months in children who had received two MV or one MV .
METHODS	Mortality rates ( MR ) were compared in Cox models producing mortality rate ratios ( MRR ) .
RESULTS	A total of 5141 children were randomized to NVAS ( N = 3015 ) or placebo ( N = 2126 ) and were later randomized to early MV ( N = 1700 ) or no early MV ( N = 3441 ) .
RESULTS	Between 4.5 and 8 months , NVAS compared with placebo was associated with higher mortality in early MV recipients ( MR = 30 versus MR = 0 , p = 0.01 ) , but not in children who did not receive early MV ( p for interaction between NVAS and early MV = 0.03 ) .
RESULTS	From 9 to 17 months NVAS was not associated with mortality .
RESULTS	Overall , from 4.5 to 17 months NVAS was associated with increased mortality in early MV recipients ( Mortality rate ratio = 5.39 ( 95 % confidence interval : 1.62 , 17.99 ) ) .
CONCLUSIONS	These observations indicate that NVAS may interact with vaccines given several months later .
CONCLUSIONS	This may have implications for the planning of future child intervention programs .

###25528898
OBJECTIVE	To evaluate the efficacy and safety of adjunctive eslicarbazepine acetate ( ESL ) in patients with refractory partial-onset seizures .
METHODS	This randomized , placebo-controlled , double-blind , parallel-group , phase III study was conducted at 173 centers in 19 countries , including the United States and Canada .
METHODS	Eligible patients were aged 16 years and had uncontrolled partial-onset seizures despite treatment with 1-2 antiepileptic drugs ( AEDs ) .
METHODS	After an 8-week baseline period , patients were randomized to once-daily placebo ( n = 226 ) , ESL 800 mg ( n = 216 ) , or ESL 1,200 mg ( n = 211 ) .
METHODS	Following a 2-week titration period , patients received ESL 800 or 1,200 mg once-daily for 12 weeks .
METHODS	Seizure data were captured and documented using event-entry or daily entry diaries .
RESULTS	Standardized seizure frequency ( SSF ) during the maintenance period ( primary end point ) was reduced with ESL 1,200 mg ( p = 0.004 ) , and there was a trend toward improvement with ESL 800 mg ( p = 0.06 ) , compared with placebo .
RESULTS	When data for titration and maintenance periods were combined , ESL 800 mg ( p = 0.001 ) and 1,200 mg ( p < 0.001 ) both reduced SSF .
RESULTS	There were no statistically significant interactions between treatment response and geographical region ( p = 0.38 ) or diary version ( p = 0.76 ) .
RESULTS	Responder rate ( 50 % reduction in SSF ) was significantly higher with ESL 1,200 mg ( 42.6 % , p < 0.001 ) but not ESL 800 mg ( 30.5 % , p = 0.07 ) than placebo ( 23.1 % ) .
RESULTS	Incidence of treatment-emergent adverse events ( TEAEs ) and TEAEs leading to discontinuation increased with ESL dose .
RESULTS	The most common TEAEs were dizziness , somnolence , nausea , headache , and diplopia .
CONCLUSIONS	Adjunctive ESL 1,200 mg once-daily was more efficacious than placebo in adult patients with refractory partial-onset seizures .
CONCLUSIONS	The once-daily 800 mg dose showed a marginal effect on SSF , but did not reach statistical significance .
CONCLUSIONS	Both doses were well tolerated .
CONCLUSIONS	Efficacy assessment was not affected by diary format used .

###24895806
OBJECTIVE	To determine whether the use of narrow-band imaging ( NBI ) system could enhance the detection rate of esophageal squamous cell carcinoma and precancerous lesions during endoscopic examination of the esophagus .
METHODS	113 patients were randomized to undergo endoscopic examination using high definition television ( HDTV ) narrow band imaging ( NBI ) endoscopy or HDTV WL endoscopy .
METHODS	The primary endpoint was the difference in the neoplasm miss rate , and secondary outcome was the neoplasm detection rate .
RESULTS	The number of esophageal cancer and high grade intraepithelial neoplasia lesions detected by HD-NBI and HD-WL was 45 and 21 , respectively .
RESULTS	The neoplasm miss rate per lesion and per patient with HD-NBI showed significant difference compared with that of HD-WL ( P < 0.05 ) .
RESULTS	Characteristics of lesions missed by use of HD-NBI were similar to those missed by use of HD-WL ; all missed lesions were high grade intraepithelial neoplasia lesions .
RESULTS	Significant difference was observed between NBI and WL in adenoma detection rate ( 70.2 % vs. 35.7 % , P < 0.01 ) .
CONCLUSIONS	Endoscopy with HD-NBI seems to improve the detection of esophageal cancer and precancerous lesions , high definition may be tested for its effect on detection of esophageal cancer and precancerous lesions in the future .
CONCLUSIONS	These results indicate that endoscopy routinely using the NBI system for the surveillance of esophageal cancer and precancerous lesions may be recommended .

###24360025
OBJECTIVE	This single-center , prospective , randomized , double-blind , 2-arm , parallel group comparison trial was performed to establish whether the adult-sized laryngeal mask airway ( LMA ) Classic ( The Laryngeal Mask Company Ltd , Henley-on-Thames , UK ) could be used safely without any consideration of cuff hyperinflation when a cuff of the LMA Classic was inflated using half the maximum inflation volume or the resting volume before insertion of device .
METHODS	Eighty patients aged 20 to 70 years scheduled for general anesthesia using the LMA Classic were included .
METHODS	Before insertion , the cuff was partially filled with half the maximum inflation volume in the half volume group or the resting volume created by opening the pilot balloon valve to equalize with atmospheric pressure in the resting volume group .
METHODS	Several parameters regarding insertion , intracuff pressure , airway leak pressure , and leakage volume/fraction were collected after LMA insertion .
RESULTS	The LMA Classic with a partially inflated cuff was successfully inserted in all enrolled patients .
RESULTS	Both groups had the same success rate of 95 % at the first insertion attempt .
RESULTS	The half volume group had a lower mean intracuff pressure compared with the resting volume group ( 54.5 16.1 cm H2O vs 61.8 16.1 cm H2O ; P = .047 ) .
RESULTS	There was no difference in airway leak pressure or leakage volume/fraction between the 2 groups under mechanical ventilation .
CONCLUSIONS	The partially inflated cuff method using half the maximum recommended inflation volume or the resting volume is feasible with the adult-sized LMA Classic , resulting in a high success rate of insertion and adequate range of intracuff pressures .

###24763663
OBJECTIVE	With advances in imaging and radiotherapy , the prognostic value of skull-base invasion in nasopharyngeal carcinoma ( NPC ) needs to be reassessed .
OBJECTIVE	We aimed to define a classification system and evaluate the prognostic value of the classification of magnetic resonance imaging ( MRI ) - detected skull-base invasion in NPC treated with intensity-modulated radiotherapy ( IMRT ) .
METHODS	We retrospectively reviewed 749 patients who underwent MRI and were subsequently histologically diagnosed with nondisseminated NPC and treated with IMRT .
RESULTS	MRI-detected skull-base invasion was not found to be an independent prognostic factor for overall survival ( OS ) , distant metastasis-free survival ( DMFS ) , local relapse-free survival ( LRFS ) , or disease-free survival ( DFS ; p > 0.05 for all ) .
RESULTS	Skull-base invasion was classified according to the incidence of each site ( type I sites inside pharyngobasilar fascia and clivus vs. type II sites outside pharyngobasilar fascia ) .
RESULTS	The 5-year OS , DMFS , LRFS , and DFS rates in the classification of skull-base invasion in NPC were 83 vs. 67 % , 85 vs. 75 % , 95 vs. 88 % , and 76 vs. 62 % , respectively ( p < 0.05 for all ) .
RESULTS	Multivariate analysis indicated the classification of skull-base invasion was an independent prognostic factor .
CONCLUSIONS	MRI-detected skull-base invasion is not an independent prognostic factor in patients with NPC treated with IMRT .
CONCLUSIONS	However , classification according to the site of invasion has prognostic value .
CONCLUSIONS	Therefore , patients with various subclassifications of stage T3 disease may receive treatment with different intensities ; however , further studies are warranted to prove this .

###24722932
BACKGROUND	Remote Patient Management for chronic heart failure ( CHF ) is gaining increasing importance in health care .
BACKGROUND	Telemonitoring is defined as daily measuring of health parameters by the patient and their transmission to a telemedical centre .
BACKGROUND	The adherence of this action by the patient can be considered as a measure for RPM adoption .
METHODS	The randomized controlled clinical trial TIM-HF ( NCT 00543881 ) was conducted between 2008 and 2010 with 710 CHF patients with the primary endpoint total mortality for a mean follow-up of 21.5 7.2 months .
METHODS	The non-prespecified analysis of adherence to daily measuring of ECG , blood pressure , weight and self-assessment was focused on sociodemographic and disease-related factors of the 354 RPM patients .
RESULTS	The mean adherence to telemonitoring was more than 80 % ( absolute adherence : 81.8 22.8 % , relative adherence : 88.9 21.5 % ) .
RESULTS	From the beginning of treatment 6.5 % of the patients ( 23/354 ) have shown an adherence below average .
RESULTS	The high adherence of the majority of the patients was stable for the entire study duration and irrespective of age , sex , severity of the disease and the presence of mild to moderate depression .
CONCLUSIONS	A high adherence can be achieved by individual training of the patient regarding the handling of his disease , the use of telemedical devices and an easy-to-use telemonitoring system .
CONCLUSIONS	The majority of the informed self-determined CHF patients NYHA class II/III are adopting telemonitoring and are adherent in the long term .

###24872027
BACKGROUND	Improved smoking cessation rates are urgently required if New Zealand is to reach its target of a smokefree nation by 2025 , during which some 600,000 smokers will need to quit .
BACKGROUND	Nicotine replacement therapy remains a core part of the pharmacological approach to smoking cessation .
BACKGROUND	Oral nicotine solutions with rapid onset have recently become available .
BACKGROUND	We have examined the effect of a nicotine spray and a nicotine patch on smoking cessation for 12 months .
METHODS	We enrolled potential participants-smokers wanting to quit aged 18-70 years , who smoked 9 cigarettes per day-with Fagerstrm Test of Nicotine Dependence score 3 in a double-blind trial in 3 trial sites .
METHODS	Smokers were randomized to a nicotine or placebo spray for 6 months , and all received nicotine patches daily for 5 months .
METHODS	They were followed at regular intervals for 12 months .
RESULTS	A total of 1,423 subjects were randomized to nicotine oral spray ( 1mg of nicotine free base per spray ) plus nicotine patch or a placebo spray and nicotine patch .
RESULTS	The nicotine mouth spray plus nicotine patch showed significant improvements in prolonged abstinence for all measures to 6 months ( 7 consecutive days at each visit for 6 months : 15.5 % vs. 10.6 % ; p = .006 ) for the combination versus placebo and nicotine patch .
RESULTS	Thereafter , the differences were not significant .
CONCLUSIONS	The addition of a nicotine mouth spray to a nicotine replacement patch in a population of smokers receiving a low level of behavioral support improved early quitting , but the effects were not sustained .

###24447043
BACKGROUND	Improving the carbohydrate quality of the diet by replacing the common cereal staple white rice ( WR ) with brown rice ( BR ) could have beneficial effects on reducing the risk for diabetes and related complications .
BACKGROUND	Hence we aimed to compare the effects of BR , WR , and BR with legumes ( BRL ) diets on 24-h glycemic and insulinemic responses among overweight Asian Indians .
METHODS	Fifteen overweight ( body mass index , 23 kg/m ( 2 ) ) Asian Indians without diabetes who were 25-45 years old participated in a randomized crossover study .
METHODS	Test meals ( nonisocaloric , ad libitum ) were identical except for the type of rice and the addition of legumes ( 50 g/day ) and were provided for 5 consecutive days .
METHODS	Glucose profiles were assessed using the Medtronic MiniMed ( Northridge , CA ) iPro2 continuous glucose monitoring device .
METHODS	The mean positive change from baseline glucose concentration was calculated as the daily incremental area under the curve ( IAUC ) on each test day for 5 days and averaged .
METHODS	Fasting serum insulin was measured prior to and at the end of each test diet .
RESULTS	The percentage difference in 5-day average IAUC was 19.8 % lower in the BR group than in the WR group ( P = 0.004 ) .
RESULTS	BRL further decreased the glycemic response ( 22.9 % lower compared with WR ( P = 0.02 ) .
RESULTS	The 5-day percentage change in fasting insulin was 57 % lower ( P = 0.0001 ) for the BR group and 54 % lower for the BRL group compared with the 5-day percentage change observed in the WR group .
RESULTS	The glycemic and insulinemic responses to the BR and BRL diets were not significantly different .
CONCLUSIONS	Consumption of BR in place of WR can help reduce 24-h glucose and fasting insulin responses among overweight Asian Indians .

###24239790
OBJECTIVE	To investigate the effects of combination cathodal transcranial direct current stimulation ( tDCS ) and virtual reality ( VR ) therapy for upper extremity ( UE ) training in patients with subacute stroke .
METHODS	Pilot randomized controlled trial .
METHODS	Patients were randomly assigned to 1 of 3 groups : group A received cathodal tDCS , group B received VR , and group C received combination therapy ( cathodal tDCS was simultaneously applied during VR therapy ) .
METHODS	University hospital .
METHODS	Patients ( N = 59 ) with impaired unilateral UE motor function after stroke .
METHODS	Fifteen sessions of treatment over a 3-week period .
METHODS	The Modified Ashworth Scale , manual muscle test ( MMT ) , Manual Function Test ( MFT ) , Fugl-Meyer Scale ( FMS ) , and Box and Block Test were used to assess UE function .
METHODS	To evaluate activities of daily living , the Korean-Modified Barthel Index ( K-MBI ) was used .
METHODS	All outcomes were measured before and immediately after treatment .
RESULTS	After treatment , all groups demonstrated significant improvements in MMT , MFT , FMS , and K-MBI scores .
RESULTS	The change in MFT and FMS scores was different between the 3 groups .
RESULTS	Post hoc analysis revealed that the improvement of MFT and FMS scores in group C was significantly higher than those of the other 2 groups .
CONCLUSIONS	In the present pilot study , the combination of brain stimulation using tDCS and peripheral arm training using VR could facilitate a stronger beneficial effect on UE impairment than using each intervention alone .
CONCLUSIONS	This combination therapy might be a helpful method to enhance recovery of the paretic UE in patients with stroke .

###25028379
OBJECTIVE	To evaluate the safety and efficacy of once-weekly subcutaneous rilonacept 160 mg for prevention of gout flares in patients initiating or continuing urate-lowering therapy ( ULT ) .
METHODS	This phase III study was conducted in the United States , South Africa , Europe , and Asia .
METHODS	Adults ( n = 1315 , 18-80 yrs ) with gout , who were initiating or continuing ULT , were randomized to treatment with weekly subcutaneous injections of rilonacept 160 mg or placebo for 16 weeks followed by a 4-week safety followup .
METHODS	The primary endpoint was safety , assessed by adverse events ( AE ) and laboratory values .
METHODS	Efficacy was a secondary endpoint .
RESULTS	Demographic and clinical characteristics were similar between treatments ; predominantly male ( 87.8 % ) , mean age 52.7 11.3 years .
RESULTS	Patients with 1 AE were 66.6 % with rilonacept versus 59.1 % placebo , with slightly more AE-related withdrawals with rilonacept ( 4.7 % vs 3.0 % ) because of the greater incidence of injection site reactions ( 15.2 % rilonacept , 3.3 % placebo ) .
RESULTS	Serious AE were similar in both groups , as were serious infections ( 0.9 % placebo , 0.5 % rilonacept ) ; no tuberculosis or opportunistic infections occurred .
RESULTS	Most common AE were headache , arthralgia , injection site erythema , accidental overdose , and pain in extremity .
RESULTS	Of the 6 deaths , only 1 in the placebo group was considered treatment-related .
RESULTS	At Week 16 , rilonacept resulted in 70.3 % fewer gout flares per patient ( p < 0.0001 ) , fewer patients with 1 and 2 gout flares ( p < 0.0001 ) , and 64.9 % fewer gout flare days ( p < 0.0001 ) relative to placebo .
CONCLUSIONS	Weekly subcutaneous administration of rilonacept 160 mg showed no new safety signals .
CONCLUSIONS	The safety profile was consistent with previous studies .
CONCLUSIONS	Rilonacept also significantly reduced the risk of gout flares .
CONCLUSIONS	Clinicaltrials.gov identifier NCT00856206 ; EudraCT No. 2008-007784-16 .

###24241365
BACKGROUND	Haemodiafiltration ( HDF ) with high reinfusion volumes is the most effective technique for clearing uraemic toxins .
BACKGROUND	There are various modalities depending on the location where the replacement volume is administered in the extracorporeal circuit : pre-dilution , mixed or mid-dilution and post-dilution , in which the infusion is carried out pre-dilution , pre - and post-dilution simultaneously and post-dilution , respectively .
OBJECTIVE	Compare the clearance of small , medium-sized and protein-bound molecules and the convective volume administered in online HDF ( OL-HDF ) in post-dilution and mixed ( pre-post-dilution ) infusion .
METHODS	A prospective , randomised , crossover study comparing post-dilution and mixed OL-HDF .
METHODS	Patients ( n = 8 ) were randomly assigned to receive 6 sessions in each technique .
METHODS	We conducted 89 sessions , of which 68 were at a scheduled time ( ST ) and 21 at an effective time ( ET ) .
METHODS	We determined the reduction rate ( RR ) percentages for various substances and the infusion volumes .
METHODS	The RR study was performed using ET .
RESULTS	The KT value obtained was greater with post-dilution OL-HDF [ 68 ( 8.1 ) compared to 64.9 ( 8.8 ) litres ] ( P = .009 ) when patients were dialysed at ST. This difference disappeared when dialysis was performed at ET .
RESULTS	The difference between ST and ET was greater in mixed HDF than in post-dilution HDF [ 10.3 ( 7.4 ) compared to 6.5 ( 3.1 ) minutes , P = .02 ] .
RESULTS	We found no differences in the RR of the substances analysed .
CONCLUSIONS	Mixed OL-HDF is not inferior to post-dilution OL-HDF either in the clearance of small and medium-sized molecules or in the clearance of protein-bound molecules at the same ET .

###26410977
BACKGROUND	Prescribing inhalers without imparting adequate education regarding proper technique of their usage may result in suboptimal clinical improvement and wastage of medication .
BACKGROUND	Training interventions using a standard check-list may help improve faulty techniques and enhance drug efficacy .
METHODS	Patients using metered dose inhaler ( MDI ) were included in the study .
METHODS	Inhaler technique was first evaluated at baseline using a standard check-list of recommended steps ( National Institute of Health guidelines ; see Table ) and scores were given for each step correctly performed .
METHODS	Those who could not perform all steps correctly were given training intervention .
METHODS	The patients were assigned to two methods of educational intervention ; one group was trained by providing written material giving step-wise instructions while the other group was given an actual physical demonstration using a placebo device .
METHODS	The technique was re-evaluated and scored following each educational session , and continued till the patient achieved a full score , or for a maximum of 3 sessions , whichever occurred earlier .
METHODS	Median score was calculated after each session and was compared between the two groups .
METHODS	Each patient was followed up after two months and the re-evaluated the same way .
RESULTS	One hundred and seventeen subjects were enrolled in the study ( 59 in the written group and 57 in the practical demonstration group ) .
RESULTS	At baseline , only 1 of the 117 subjects could perform all the steps of inhaler usage correctly .
RESULTS	This patient was , therefore , not provided the inhaler technique education .
RESULTS	The overall median ( range ) score of the whole group was 3 ( range 1-8 ) .
RESULTS	This score rose to 6 , 7 and 8 after each of the three subsequent educational intervention sessions .
RESULTS	At one-month follow-up , the median score dropped to 7 and improved with a repeat educational session as previously done .
RESULTS	A significant difference was observed in the median score improvement achieved in the practical demonstration group compared with the written instruction group ( 3.0 versus 2.0 respectively , p < 0.001 ) .
CONCLUSIONS	Inhalation technique of patients improves after imparting systematic educational intervention .
CONCLUSIONS	A practical demonstration of all the steps proved more effective than simple verbal/written advice .
CONCLUSIONS	In view of increasing errors being committed over a period of time , repeated demonstration of the proper technique using a standard check-list significantly improves the errors committed during inhaler use .

###24850280
OBJECTIVE	Cigarette smoking leads to upregulation of nicotinic acetylcholine receptors ( nAChRs ) in the human brain , including the common 42 * nAChR subtype .
OBJECTIVE	While subjective aspects of tobacco dependence have been extensively examined as predictors of quitting smoking with treatment , no studies to our knowledge have yet reported the relationship between the extent of pretreatment upregulation of nAChRs and smoking cessation .
OBJECTIVE	To determine whether the degree of nAChR upregulation in smokers predicts quitting with a standard course of treatment .
METHODS	Eighty-one tobacco-dependent cigarette smokers ( volunteer sample ) underwent positron emission tomographic ( PET ) scanning of the brain with the radiotracer 2-FA followed by 10 weeks of double-blind , placebo-controlled treatment with nicotine patch ( random assignment ) .
METHODS	Pretreatment specific binding volume of distribution ( VS/fP ) on PET images ( a value that is proportional to 42 * nAChR availability ) was determined for 8 brain regions of interest , and participant-reported ratings of nicotine dependence , craving , and self-efficacy were collected .
METHODS	Relationships between these pretreatment measures , treatment type , and outcome were then determined .
METHODS	The study took place at academic PET and clinical research centers .
METHODS	Posttreatment quit status after treatment , defined as a participant report of 7 or more days of continuous abstinence and an exhaled carbon monoxide level of 3 ppm or less .
RESULTS	Smokers with lower pretreatment VS/fP values ( a potential marker of less severe nAChR upregulation ) across all brain regions studied were more likely to quit smoking ( multivariate analysis of covariance , F8 ,69 = 4.5 ; P < .001 ) , regardless of treatment group assignment .
RESULTS	Furthermore , pretreatment average VS/fP values provided additional predictive power for likelihood of quitting beyond the self-report measures ( stepwise binary logistic regression , likelihood ratio 21 = 19.8 ; P < .001 ) .
CONCLUSIONS	Smokers with less upregulation of available 42 * nAChRs have a greater likelihood of quitting with treatment than smokers with more upregulation .
CONCLUSIONS	In addition , the biological marker studied here provided additional predictive power beyond subjectively rated measures known to be associated with smoking cessation outcome .
CONCLUSIONS	While the costly , time-consuming PET procedure used here is not likely to be used clinically , simpler methods for examining 42 * nAChR upregulation could be tested and applied in the future to help determine which smokers need more intensive and/or lengthier treatment .
BACKGROUND	clinicaltrials.gov Identifier : NCT01526005 .

###24251677
OBJECTIVE	The purpose of this study was to describe the process of implementing a diabetes prevention program provided by homecare nurses to residents of public housing communities .
METHODS	A cluster randomization pilot study was conducted comparing enhanced standard care ( 2 interactive classes on diabetes prevention ) to a diabetes prevention program ( 7 interactive classes and behavioral support ) .
METHODS	The sample ( n = 67 ) was primarily female ( 79 % ) , nonwhite ( 76 % ) , unpartnered ( 83 % ) , with a mean age of 40 years , and an average of 3 children .
METHODS	Mixed methods were used to evaluate the implementation process .
METHODS	Data were collected on attendance , attrition , and protocol implementation .
METHODS	Interviews were conducted with nurses and community health workers who assisted with program implementation .
RESULTS	Homecare nurses were able to implement a diabetes prevention program in public housing communities , with a protocol implementation of 83 % across classes and groups .
RESULTS	Attendance was suboptimal with 60 % for the enhanced standard care group and 54 % for the diabetes prevention group .
RESULTS	Nurses and community health workers were resourceful and positive about program implementation .
CONCLUSIONS	Linking existing resources , such as a homecare agency with a public housing community , is one approach to disseminate diabetes prevention programs .

###24610309
BACKGROUND	Randomized studies have shown optimal medical therapy to be as efficacious as revascularization in stable ischemic heart disease ( IHD ) .
BACKGROUND	It is not known if these efficacy results are reflected by real-world effectiveness .
OBJECTIVE	To evaluate the comparative effectiveness of routine medical therapy versus revascularization with percutaneous coronary intervention ( PCI ) or coronary artery bypass grafting ( CABG ) in stable IHD .
METHODS	Observational cohort study .
METHODS	Stable IHD patients from 1 October 2008 to 30 September 2011 , identified using a Registry of all angiography patients in Ontario , Canada .
METHODS	Revascularization , defined as PCI/CABG within 90 days after index angiography .
METHODS	Death , myocardial infarction ( MI ) or repeat PCI/CABG .
METHODS	Revascularization was compared to medical therapy using a ) multivariable Cox-proportional hazard models with therapy strategy treated as a time-varying covariate ; and b ) a propensity score matched analysis .
METHODS	Post-angiography medication use was determined .
RESULTS	We identified 39,131 stable IHD patients , of whom 15,139 were treated medically , and 23,992 were revascularized ( PCI = 15,604 ; CABG = 8,388 ) .
RESULTS	Mean follow-up was 2.5 years .
RESULTS	Revascularization was associated with fewer deaths ( HR 0.76 ; 95 % CI 0.68-0 .84 ; p < 0.001 ) , MIs ( HR 0.78 ; 95 % CI 0.72-0 .85 ; p < 0.001 ) and repeat PCI/CABG ( HR 0.59 ; 95 % CI 0.50-0 .70 ; p < 0.001 ) than medical therapy .
RESULTS	In the propensity-matched analysis of 12,362 well-matched pairs of revascularized and medical therapy patients , fewer deaths ( 8.6 % vs 12.7 % ; HR 0.75 ; 95 % CI 0.69-0 .81 ; p < 0.001 ) , MIs ( 11.7 % vs 14.4 % ; HR 0.84 ; 95 % CI 0.77-0 .93 p < 0.001 ) and repeat PCI/CABG ( 17.4 % vs 24.1 % ; HR 0.67 ; 95 % 0.63-0 .71 ; p < 0.001 ) occurred in revascularized patients , over the 4.1 years of follow-up .
RESULTS	The revascularization patients had higher uptake of clopidogrel ( 70.3 % vs 27.2 % ; p < 0.001 ) , - blockers ( 78.2 % vs 76.7 % ; p = 0.010 ) , and statins ( 94.7 % vs 91.5 % , p < 0.001 ) in the 1-year post-angiogram .
CONCLUSIONS	Stable IHD patients treated with revascularization had improved risk-adjusted outcomes in clinical practice , potentially due to under-treatment of medical therapy patients .

###24676290
BACKGROUND	Colonoscopy is the most frequent exam used to evaluate colonic mucosa , allowing the diagnosis and treatment of many diseases .
BACKGROUND	The appropriate bowel preparation is indispensable for the realization of colonoscopy .
BACKGROUND	Therefore , it is necessary the use of laxative medications , preferentially by oral administration .
OBJECTIVE	To compare two medications used in bowel preparation in adult patients going to ambulatory colonoscopy and to analyze the patients ' profile .
METHODS	A double-blind prospective study with 200 patients , randomized in two groups : one that received polyethilene glycol and another that received lactulose .
METHODS	The patients answered to questionnaires to data compilation , as tolerance , symptoms and complications related to preparation .
METHODS	Besides , it was also evaluated the prepare efficacy related to the presence of fecal residue .
RESULTS	Intestinal habit alterations and abdominal pain were the main reasons to realize the exams and hypertension was the most prevalent comorbidity .
RESULTS	Ten percent of the ones who received lactulose did n't get to finish the preparation and 50 % considered the taste `` bad , but tolerable '' .
RESULTS	The most common subjective symptom after the medication was nausea , especially after lactulose .
RESULTS	During the exam , most of the patients who used lactulose had a `` light discomfort '' and the ones who used polyethilene glycol considered the discomfort as `` tolerable '' .
RESULTS	The quality of the preparation was good in 75 % , undependable of the medication that was used .
CONCLUSIONS	Polyethilene glycol was more tolerable when compared to lactulose , without difference on the quality of the preparation .

###24388379
OBJECTIVE	To compare preservative-free ketotifen 0.025 % ophthalmic solution to olopatadine 0.1 % ophthalmic solution in with the treatment of seasonal allergic conjunctivitis ( SAC ) in clinical practice .
METHODS	This was a comparative , randomised , investigator-masked , pilot clinical study in adult patients with documented history of SAC and presenting with moderate to severe itching and conjunctival hyperemia .
METHODS	Eligible patients initiated either ketotifen or olopatadine treatment at a dose of one drop twice daily for 28days .
METHODS	The resolution of ocular signs and symptoms was assessed on day 7 and day 28 .
METHODS	Itching was also assessed within 15minutes following the first instillation ( day 0 ) .
METHODS	Conjunctival impression cytology was performed at each visit to assess the evolution of ICAM-1 expression ( day 0 , 7 and 28 ) .
RESULTS	Seventy-five patients were randomised ( ketotifen : 38 patients ; olopatadine : 37 patients ) .
RESULTS	At day 28 , the composite score for primary criteria ( itching , tearing , and conjunctival hyperemia ) improved from 6.81.2 to 0.91.0 in the Ketotifen group , without statistically significant difference between treatment groups ( P = 0.67 ) .
RESULTS	There was no relevant difference between treatment groups in other efficacy parameters , except a trend for a more rapid resolution of conjunctival hyperemia in the Ketotifen group .
RESULTS	Both drugs were well tolerated , with a trend for a better tolerability reported by patients on ketotifen compared to those on olopatadine at day 7 ( P = 0.054 ) .
CONCLUSIONS	A rapid and comparable improvement in SAC was achieved after 28days of treatment with both preservative-free ketotifen and preserved olopatadine ophthalmic solutions , with a slightly better ocular tolerance with unpreserved ketotifen 0.025 % eye drops .

###24363029
BACKGROUND	Adalimumab is a fully human , monoclonal antibody against tumor necrosis factor that is approved in Western countries for the treatment of moderately to severely active ulcerative colitis ( UC ) .
METHODS	This 52-week , phase 2/3 , randomized , double-blind study evaluated adalimumab for induction and maintenance treatment in 273 anti-TNF-naive Japanese patients with UC who were refractory to corticosteroids , immunomodulators , or both .
METHODS	Patients received placebo , adalimumab 80/40 ( 80mg at week 0 , then 40mg every other week ) , or adalimumab 160/80 ( 160/80mg at weeks 0/2 , then 40mg every other week ) in addition to background UC therapy .
RESULTS	At week 8 , remission rates were similar among treatment arms , but more patients treated with adalimumab 160/80 achieved response ( placebo , 35 % ; 80/40 , 43 % ; 160/80 , 50 % ; P = 0.044 for 160/80 vs placebo ) and mucosal healing ( placebo , 30 % ; 80/40 , 39 % ; 160/80 , 44 % ; P = 0.045 for 160/80 vs placebo ) compared with placebo .
RESULTS	At week 52 , more patients receiving adalimumab 40mg every other week achieved response ( 18 vs 31 % ; P = 0.021 ) , remission ( 7 vs 23 % ; P = 0.001 ) , and mucosal healing ( 16 vs 29 % ; P = 0.015 ) compared with placebo .
RESULTS	Week 8 response to adalimumab was associated with greater rates of response ( 61 % ) , remission ( 46 % ) , and mucosal healing ( 57 % ) at week 52 relative to the overall population .
RESULTS	Rates of serious adverse events were similar between treatment arms .
CONCLUSIONS	Induction with adalimumab 160/80mg led to early response and mucosal healing .
CONCLUSIONS	Maintenance adalimumab had greater rates of long-term response , remission , and mucosal healing compared with placebo .
CONCLUSIONS	No new safety signals were identified .

###24883449
BACKGROUND	Electrical reconnection of the pulmonary veins ( PVs ) plays a key role in the recurrence of atrial fibrillation ( AF ) after ablative treatment .
BACKGROUND	This randomized controlled study tested the hypothesis that prolonged ablations , on areas that may be critical for left atrial ( LA ) - PV conduction , can significantly reduce the rate of acute PV reconnection and AF recurrence .
METHODS	Patients with paroxysmal AF were randomly assigned to either a control or an add-on group.Ostial PV isolation ( PVI ) was performed by point-to-point RF ablation ( irrigated tip , 30 Watts , 30 seconds ) .
METHODS	An ostial segment was assumed to be critical for LA-PV connection if any of the following reactions occurred during RF application : ( 1 ) sudden delay of LA-PV conduction , ( 2 ) change of activation sequence , and ( 3 ) PVI .
METHODS	In this case , RF application was prolonged from 30 seconds to 90 seconds in the add-on group only .
RESULTS	A total of 131 patients ( 58 11 years , 47 female ) were assigned to a control ( n = 64 ) and an add-on ( n = 67 ) group .
RESULTS	Ablation time was longer in the add-on ( 48 16 minutes vs 37 15 minutes , P = 0.03 ) .
RESULTS	Acute PV reconnection was observed in 20 of 64 controls and in eight of 66 add-on patients ( 31 % vs 12 % , P < 0.001 ) .
RESULTS	During a follow-up of 26 months , AF recurred in 33 of 64 controls and in 16 of 66 add-on patients ( 52 % vs 24 % , P = 0.001 ) after a single ablation procedure .
CONCLUSIONS	Prolonged radiofrequency application on critical segments of LA-PV connection is a safe and effective ablative strategy that significantly reduces acute PV reconnection and AF recurrence rates after a single ablation procedure for paroxysmal AF .

###25370598
BACKGROUND	Low-contrast visual acuity ( LCVA ) , a sensitive measure of visual function in multiple sclerosis ( MS ) , demonstrated treatment effects as a secondary outcome measure in the Phase 3 trial of natalizumab , AFFIRM .
BACKGROUND	In these posttrial analyses , we studied the relation of visual function to quality of life ( QOL ) , magnetic resonance imaging ( MRI ) measures , and Expanded Disability Status Scale ( EDSS ) scores .
METHODS	At baseline and at 52 and 104 weeks in AFFIRM , patients underwent binocular testing of LCVA ( 1.25 % and 2.5 % contrast ) and high-contrast visual acuity ( HCVA ) .
METHODS	Vision-specific QOL was assessed by the Impact of Visual Impairment Scale ( IVIS ) , whereas the SF-36 Health Survey and Visual Analog Scale were administered as generic QOL measures and the EDSS as a measure of neurologic impairment .
RESULTS	Among QOL measures , IVIS scores showed the most significant correlations with visual dysfunction at all time points in the trial ( r = -0.25 to -0.45 , P < 0.0001 for LCVA and HCVA ) .
RESULTS	Higher MRI T1 - and T2-lesion volumes were also associated with worse vision scores at all time points ( P < 0.0001 ) .
RESULTS	Clinically meaningful worsening ( progression ) of LCVA was noted in substantial proportions of patients in AFFIRM and was prevalent even among those without EDSS progression over 2 years ( 21.9 % with LCVA progression at 2.5 % contrast ; 26.2 % at 1.25 % contrast ) .
RESULTS	HCVA worsened in only 3.7 % of patients without EDSS progression .
CONCLUSIONS	Loss of visual function , particularly as measured by LCVA , was common in AFFIRM , occurring in > 20 % of patients .
CONCLUSIONS	Both LCVA and HCVA scores reflect vision-specific aspects of QOL , but LCVA provides information about disability progression not entirely captured by the EDSS .
CONCLUSIONS	Vision represents a key dimension of outcome assessment for MS and adds valuable information on disability and QOL that can be useful to clinicians .

###25325925
OBJECTIVE	The objective of this study was to assess and compare the features of the Bemfola , Gonal-f and Puregon injection pens .
METHODS	Females who intended to undergo hormonal treatment received the three different pens in a randomized , consecutive sequence .
METHODS	For each of the pens , the potential patients completed an Injection Pen Assessment Questionnaire , as well as a questionnaire comparing the handling , convenience and preference among the three pens .
RESULTS	The mean score on the visual analogue scale ( VAS ) for the Bemfola pen ( BP ) was 77.8 14.0 ; for the Puregon pen ( PP ) , 72.1 12.4 ; and for the Gonal-f pen ( GP ) , 68.6 16.4 .
RESULTS	The BP was superior to both competitor devices in pen size , inconspicuousness , ease of use and dose changing ; no significant differences to both competitor pens were observed in the way the pen looks , the way the pen feels and the ease of injection of the volume .
RESULTS	The ` overall ' assessment was significantly better for the BP when compared to the GP ( p = 0.0019 ) , while no significant difference was observed between the BP and the PP .
CONCLUSIONS	This study demonstrated significantly higher ratings for pen size , inconspicuousness , ease of use and dose adjustment for the BP compared to other marketed pens .

###24925440
OBJECTIVE	To investigate the effects , and their reversibility , of multiple oral voriconazole doses on a variety of visual tests in healthy male volunteers .
METHODS	Single-center , double-blind , randomized , placebo-controlled , parallel-group study in 36 volunteers who received voriconazole ( n = 18 , 400 mg every 12 h on day 1 , then 300 mg every 12 h for 27.5 days ) or matched placebo ( n = 18 ) .
METHODS	Electroretinograms ( ERGs ) and ophthalmological examinations were performed at screening , throughout the study and at follow-up .
RESULTS	Fifteen ( 83.3 % ) volunteers treated with voriconazole experienced 1 treatment-related visual adverse events ( AEs ) ; these included enhanced visual perceptions , blurred vision , color vision changes and photophobia .
RESULTS	No serious AEs were reported .
RESULTS	Voriconazole reduced from baseline scotopic maximal a - and b-wave amplitude , shortened implicit time and decreased oscillatory potential amplitude compared with placebo .
RESULTS	Under photopic conditions , the 30-Hz flicker response amplitude was significantly reduced and was accompanied by a slight but nonsignificant prolongation of peak time .
RESULTS	These effects did not progress in degree over the treatment period , and mean changes from baseline in ERG parameters were similar to placebo by day 43 ( 14 days after end of treatment ) .
RESULTS	In the first week , color vision discrimination was impaired in the tritan axis , although this resolved by end of treatment and was similar to placebo by day 43 .
RESULTS	Mean deviation in the static visual field indicated increased sensitivity following voriconazole treatment , correlating with decreased amplitude in conjunction with shortened implicit time .
CONCLUSIONS	Effects of voriconazole on altered visual perception , ERG , color vision and static visual field thresholds are nonprogressive over a treatment period and reversible .
CONCLUSIONS	It is hypothesized that voriconazole has a pharmacological effect on rod and cone pathways including a possible mechanism of disinhibition that reversibly puts the retina in a more light-adapted state and leads to increased relative contrast sensitivity .

###24433744
BACKGROUND	Acute exacerbations of chronic obstructive pulmonary disease ( AECOP ) are key events in the natural history of the disease .
BACKGROUND	Patients with more AECOPD have worse prognosis .
BACKGROUND	There is a need of innovative models of care for patients with severe COPD and frequent AECOPD , and Telehealth ( TH ) is part of these programs .
METHODS	In a cluster assignment , controlled trial study design , we recruited 60 patients , 30 in home telehealth ( HT ) and 30 in conventional care ( CC ) .
METHODS	All participants had a prior diagnosis of COPD with a post-bronchodilator forced expiratory volume ( FEV1 ) % predicted < 50 % , age 50 years , were on long-term home oxygen therapy , and non-smokers .
METHODS	Patients in the HT group measured their vital signs on a daily bases , and data were transmitted automatically to a Clinical Monitoring Center for followed-up , and who escalated clinical alerts to a Pneumologist .
RESULTS	After 7-month of monitoring and follow-up , there was a significant reduction in ER visits ( 20 in HT vs. 57 in CC ) , hospitalizations ( 12 vs. 33 ) , length of hospital stay in ( 105 vs. 276 days ) , and even need for non-invasive mechanical ventilation ( 0 vs. 8 ) , all p < 0.05 .
RESULTS	Time to the first severe AECOPD increased from 77 days in CC to 141 days in HT ( K-M p < 0.05 ) .
RESULTS	There was no study withdrawals associated with technology .
RESULTS	All patients showed a high level of satisfaction with the HT program .
CONCLUSIONS	We conclude that HT in elderly , severe COPD patients with multiple comorbidities is safe and efficacious in reducing healthcare resources utilization .

###25130571
OBJECTIVE	To evaluate whether premature infants who received an exclusive human milk ( HM ) - based diet and a HM-derived cream supplement ( cream ) would have weight gain ( g/kg/d ) at least as good as infants receiving a standard feeding regimen ( control ) .
METHODS	In a prospective noninferiority , randomized , unmasked study , infants with a birth weight 750-1250 g were randomly assigned to the control or cream group .
METHODS	The control group received mother 's own milk or donor HM with donor HM-derived fortifier .
METHODS	The cream group received a HM-derived cream supplement if the energy density of the HM tested < 20 kcal/oz using a near infrared HM analyzer .
METHODS	Infants were continued on the protocol until 36 weeks postmenstrual age .
METHODS	Primary outcomes included growth velocities and amount of donor HM-derived fortifier used .
METHODS	The hypothesis of noninferiority was established if the lower bound of the one-sided 95 % CI for the difference in weight velocities exceeded -3 g/kg/day .
RESULTS	There were no differences between groups in baseline demographics for the 78 infants studied except racial distribution ( P = .02 ) .
RESULTS	The cream group ( n = 39 ) had superior weight ( 14.0 2.5 vs 12.4 3.0 g/kg/d , P = .03 ) and length ( 1.03 0.33 vs 0.83 0.41 cm/wk , P = .02 ) velocity compared with the control group ( n = 39 ) .
RESULTS	There were no significant differences in amount of fortifier used between study groups .
RESULTS	The 1-sided 95 % lower bound of the CI for the difference in mean velocity ( cream-control ) was 0.38 g/kg/d .
CONCLUSIONS	Premature infants who received HM-derived cream to fortified HM had improved weight and length velocity compared with the control group .
CONCLUSIONS	HM-derived cream should be considered an adjunctive supplement to an exclusive HM-based diet to improve growth rates in premature infants .

###24789859
BACKGROUND	Serum markers are used before pelvic imaging to improve specificity and positive predictive value ( PPV ) of ovarian cancer multimodal screening strategies .
METHODS	We conducted a randomized controlled pilot trial to estimate surgical PPV of a `` 2 of 3 tests positive '' screening rule , and to compare use of HE4 as a first-line ( Arm 1 ) versus a second-line ( Arm 2 ) screen , in women at high and elevated risk for epithelial ovarian cancer ( EOC ) at five study sites .
METHODS	Semiannual screening was offered to 208 women ages 25 to 80 years with deleterious BRCA germline mutations and to 834 women ages 35 to 80 years with pedigrees suggesting inherited susceptibility .
METHODS	Annual screening was offered to 130 women ages 45 to 80 years ( Risk Group 3 ) with epidemiologic and serum marker risk factors .
METHODS	Rising marker levels were identified using the parametric empirical Bayes algorithm .
RESULTS	Both strategies yielded surgical PPV above 25 % .
RESULTS	Protocol-indicated surgery was performed in 6 women , identifying two ovarian malignancies and yielding a surgical PPV in both arms combined of 33 % ( 95 % confidence interval : 4 % -78 % ) , 25 % in Arm 1 and 50 % in Arm 2 .
RESULTS	Surgical consultation was recommended for 37 women ( 26 in Arm 1 and 11 in Arm 2 ) .
RESULTS	On the basis of 12 women with at least 2 of 3 tests positive ( CA125 , HE4 , or imaging ) , an intent-to-treat analysis yielded PPV of 14 % in Arm 1 and 20 % in Arm 2 .
CONCLUSIONS	Positive screens were more frequent when HE4 was included in the primary screen .
CONCLUSIONS	HE4 may be useful as a confirmatory screen when rising CA125 is used alone as a primary screen .

###24263176
BACKGROUND	Following traumatic brain injury ( TBI ) , individuals may experience chronic problems with irritability or aggression , which may need treatment to minimize the negative impact on their relationships , home life , social interactions , community participation , and employment
OBJECTIVE	: To test the a priori hypothesis that amantadine reduces irritability ( primary hypothesis ) and aggression ( secondary hypothesis ) among individuals greater than 6 months post-TBI METHODS : : A total of 76 individuals greater than 6 months post-TBI referred for irritability management were enrolled in a parallel-group , randomized , double-blind , placebo-controlled trial of amantadine ( n = 38 ) versus placebo ( n = 38 ) .
OBJECTIVE	Study participants were randomly assigned to receive amantadine hydrochloride 100 mg twice daily versus equivalent placebo for 28 days .
OBJECTIVE	Symptoms of irritability and aggression were measured before and after treatment using the Neuropsychiatric Inventory Irritability ( NPI-I ) and Aggression ( NPI-A ) domains , as well as the NPI-Distress for these domains
RESULTS	: In the amantadine group , 80.56 % improved at least 3 points on the NPI-I , compared with 44.44 % in the group that received placebo ( P = .0016 ) .
RESULTS	Mean change in NPI-I was -4.3 in the amantadine group and -2.6 in the placebo group ( P = .0085 ) .
RESULTS	When excluding individuals with minimal to no baseline aggression , mean change in NPI-A was -4.56 in the amantadine group and -2.46 in the placebo group ( P = .046 ) .
RESULTS	Mean changes in NPI-I and NPI-A Distress were not statistically significant between the amantadine and placebo groups .
RESULTS	Adverse event occurrence did not differ between the 2 groups
CONCLUSIONS	: Amantadine 100 mg every morning and at noon appears an effective and safe means of reducing frequency and severity of irritability and aggression among individuals with TBI and sufficient creatinine clearance .

###25339206
OBJECTIVE	To investigate the effect of aerobic exercise training ( AET ) and cognitive-behavioral therapy ( CBT ) on chronic fatigue in patients with facioscapulohumeral muscular dystrophy ( FSHD ) .
METHODS	We performed a multicenter , assessor-blinded , randomized clinical trial ( RCT ) .
METHODS	Fifty-seven patients with FSHD type 1 with severe chronic fatigue were randomly allocated to AET , CBT , or usual care ( UC ) .
METHODS	Outcomes were assessed before treatment , following 16 weeks of intervention , and after a 12-week follow-up .
METHODS	A linear mixed model for repeated measurements was used to study the estimated group differences .
RESULTS	Following treatment , both the AET ( 28 participants ) and CBT ( 25 participants ) intervention groups had less fatigue relative to the UC group ( 24 participants ) , with a difference of -9.1 for AET ( 95 % confidence interval [ CI ] -12.4 to -5.8 ) and -13.3 for CBT ( 95 % CI -16.5 to -10.2 ) .
RESULTS	These beneficial effects lasted through follow-up , with a difference of -8.2 for AET ( 95 % CI -12.4 to -5.8 ) and -10.2 for CBT ( 95 % CI -14.0 to -6.3 ) .
RESULTS	The patients who received CBT had an increase in registered and experienced physical activity , sleep quality , and social participation .
RESULTS	The patients who received AET had an increase in registered physical activity only .
RESULTS	The increase in registered physical activity in both groups and the improvement in social participation following CBT were still present at follow-up .
CONCLUSIONS	This RCT shows that AET and CBT can ameliorate chronic fatigue in patients with FSHD .
METHODS	This study provides Class III evidence that , in patients with FSHD type 1 and severe chronic fatigue , AET or CBT reduces the severity of chronic fatigue .

###25249313
OBJECTIVE	To compare intraindividually two macrocyclic contrast agents - gadobutrol and gadoterate meglumine ( Gd-DOTA ) - for dynamic and quantitative assessment of relative enhancement ( RE ) in benign and malignant breast lesions .
METHODS	This was an ethically approved , prospective , single-centre , randomized , crossover study in 52 women with suspected breast lesions referred for magnetic resonance imaging ( MRI ) .
METHODS	Each patient underwent one examination with gadobutrol and one with Gd-DOTA ( 0.1 mmol/kg BW ) on a 1.5 T system 1 - 7 days apart .
METHODS	Dynamic , T1-weighted , 3D gradient echo sequences were acquired under identical conditions .
METHODS	Quantitative evaluation with at least three regions of interest ( ROI ) per lesion was performed .
METHODS	Primary endpoint was RE during the initial postcontrast phase after the first and second dynamic acquisition , and peak RE .
METHODS	All lesions were histologically proven ; differences between the examinations were evaluated .
RESULTS	Forty-five patients with a total of 11 benign and 34 malignant lesions were assessed .
RESULTS	Mean RE was significantly higher for gadobutrol than Gd-DOTA ( p < 0.0001 ) .
RESULTS	Gadobutrol showed significantly less washout ( 64.4 % ) than Gd-DOTA ( 75.4 % ) in malignant lesions ( p = 0.048 ) CONCLUSIONS : Gadobutrol has higher RE values compared with Gd-DOTA , whereas Gd-DOTA shows more marked washout in malignant lesions .
RESULTS	This might improve the detection of breast lesions and influence the specificity of breast MRI-imaging .

###26141464
BACKGROUND	The Maastricht , Asia-Pacific consensus guidelines strongly recommend eradication of Helicobacter pylori in patients who have a history of gastric cancer .
BACKGROUND	This open-label , single-center , randomized controlled trial was conducted to investigate the appropriate timing of eradication for patients undergoing gastrectomy .
METHODS	One hundred and fifty patients scheduled to undergo gastrectomy were allocated to either a preoperative or a postoperative group .
METHODS	The eradication regimen was a common triple therapy : lansoprazole , amoxicillin , and clarithromycin .
METHODS	Patients in the preoperative group were treated with the regimen , followed by surgery , and patients in the postoperative group were treated after postoperative day 8 .
METHODS	The primary end point was the proportion of patients achieving successful eradication in the remnant stomach .
METHODS	The definition of successful eradication was negativity in both the C13 urea breath test and for the antigen in feces at 6 months after surgery .
RESULTS	Eight patients were excluded , and the remaining one hundred and forty-two , 70 in the preoperative group and 72 in the postoperative group , were included on an intention to treat basis .
RESULTS	The procedures used were gastrectomy with Billroth I , Roux-en-Y , and pylorus-preserving gastrectomy in 18 , 70 , and 57 patients , respectively .
RESULTS	The proportion of patients showing successful eradication hardly differed between the 2 groups , 68.6 % vs 69.4 % ( p = 1.000 ) in the pre - and postoperative groups , respectively .
RESULTS	Subgroup analysis also demonstrated no significant difference among the reconstruction methods used .
CONCLUSIONS	Preoperative H pylori eradication therapy for gastric cancer patients scheduled for gastrectomy is not necessary , regardless of the planned reconstruction procedure .

###25333885
OBJECTIVE	Although there has been growing evidence for the efficacy of mindfulness-based cognitive therapy ( MBCT ) for different clinical populations , its effectiveness as a public mental health intervention has not been studied .
OBJECTIVE	The present study evaluates a community-based MBCT intervention for adults with mild to moderate depressive symptomatology in a large multi-site , pragmatic randomized controlled trial .
METHODS	The participants with mild to moderate depressive symptomatology were recruited from the general population and randomized to the MBCT intervention ( n = 76 ) or to a waiting list control group ( n = 75 ) .
METHODS	Participants completed measures before and after the intervention .
METHODS	Participants in the experimental condition also completed these measures at a 3-month follow-up .
RESULTS	In the experimental condition significant reductions in depression , anxiety , and experiential avoidance , and improvements in mindfulness and emotional - and psychological mental health were found , compared to the waiting list ( effect sizes Cohen 's d = 0.31-0 .56 ) .
RESULTS	These effects were sustained at the 3-month follow-up .
RESULTS	The likelihood of a clinically significant change in depressive symptoms was significantly higher for the MBCT group [ odds ratio ( OR ) 3.026 , p < 0.01 at post-treatment ; NNT = 5.10 ] .
CONCLUSIONS	MBCT as a public mental health intervention for adults with mild to moderate depressive symptoms seems effective and applicable in a natural setting .
BACKGROUND	Nederlands Trial Register NTR2096 .

###25841032
OBJECTIVE	To determine whether acute migraine treatment outcome is different in migraine with aura compared with migraine without aura .
METHODS	We examined pooled outcome data for sumatriptan treatment of migraine with and without aura from the sumatriptan/naratriptan aggregate patient database .
METHODS	We also examined similar outcome data for inhaled dihydroergotamine ( DHE ) from a single , large randomized controlled study .
RESULTS	The pooled pain-free rates 2 hours postdose for sumatriptan 100 mg were significantly higher in patients treating attacks without aura ( 32 % ) compared with the group who treated attacks with aura ( 24 % ) ( p < 0.001 ) .
RESULTS	The relative risk for pain freedom 2 hours postdose for attacks without aura was 1.33 ( 95 % confidence interval : 1.16-1 .54 ) .
RESULTS	The number needed to treat for 2 hours of pain freedom was 4.4 for attacks without aura and 6.2 for attacks with aura .
RESULTS	For the clinical trial of DHE , the 2-hour pain-free rates did not differ between patients treating attacks without aura ( 29.4 % ) compared with those who treated attacks with aura ( 27.2 % ; p = 0.65 ) .
RESULTS	The relative risk for pain freedom 2 hours postdose for attacks without aura vs with aura was 1.08 ( 95 % confidence interval : 0.77-1 .53 ) .
RESULTS	The number needed to treat for 2 hours pain free was 5.8 for attacks without aura and 5.0 for attacks with aura .
CONCLUSIONS	This post hoc analysis of pooled data from multiple randomized trials indicates that sumatriptan is less effective as acute therapy for migraine attacks with aura compared with attacks without aura .
CONCLUSIONS	In the single study of inhaled DHE , the treatment had similar efficacy for migraine attacks with and without aura .
CONCLUSIONS	Different responses of migraine with vs without aura to acute therapies may provide insight into underlying migraine mechanisms and influence the choice of acute therapies for different types of migraine attacks .

###25045825
OBJECTIVE	Adjuvanted influenza vaccines can overcome the poor antibody response of conventional non-adjuvanted vaccines in the elderly .
OBJECTIVE	We evaluated the immunogenicity , safety and clinical effectiveness of an MF59 ( ) - adjuvanted trivalent influenza vaccine ( aTIV ) compared with a non-adjuvanted vaccine ( TIV ) in subjects 65 years old , with or without co-morbidities .
METHODS	In 2010-2011 , subjects ( N = 7082 ) were randomized to receive one dose of aTIV or TIV .
METHODS	Co-primary objectives were to assess lot-to-lot consistency of aTIV , non-inferiority , superiority and immunogenicity 22 days after vaccination .
METHODS	Clinical effectiveness , reactogenicity and serious adverse events were monitored up to Day 366 .
RESULTS	The immunological equivalence of three lots of aTIV was demonstrated .
RESULTS	aTIV was not only non-inferior to TIV but also elicited significantly higher antibody responses at Day 22 than TIV against all homologous and heterologous strains , even in subjects with co-morbidities .
RESULTS	Superiority was not established .
RESULTS	Reactogenicity was higher in the aTIV group , but reactions were mild to moderate and transient .
CONCLUSIONS	aTIV elicited a significantly higher antibody response than TIV , especially against A/H3N2 strains , although superiority by pre-defined criteria was not formally met .
CONCLUSIONS	The study demonstrates potential immunological benefits of MF59-adjuvanted influenza vaccines for the elderly .
CONCLUSIONS	This trial was registered with www.clinicaltrials.gov ( NCT01162122 ) .

###25540972
BACKGROUND	Enhancing physical activity in overweight and obese individuals is an important means to promote health in this target population .
BACKGROUND	The Health Action Process Approach ( HAPA ) , which was the theoretical framework of this study , focuses on individual self-regulation variables for successful health behavior change .
BACKGROUND	One key self-regulation variable of this model is action control with its three subfacets awareness of intentions , self-monitoring and regulatory effort .
BACKGROUND	The social context of individuals , however , is usually neglected in common health behavior change theories .
BACKGROUND	In order to integrate social influences into the HAPA , this randomized controlled trial investigated the effectiveness of a dyadic conceptualization of action control for promoting physical activity .
METHODS	This protocol describes the design of a single-blind randomized controlled trial , which comprises four experimental groups : a dyadic action control group , an individual action control group and two control groups .
METHODS	Participants of this study are overweight or obese , heterosexual adult couples who intend to increase their physical activity .
METHODS	Blocking as means of a gender-balanced randomization is used to allocate couples to conditions and partners to either being the target person of the intervention or to the partner condition .
METHODS	The ecological momentary intervention takes place in the first 14 days after baseline assessment and is followed by another 14 days diary phase without intervention .
METHODS	Follow-ups are one month and six months later .
METHODS	Subsequent to the six-months follow-up another 14 days diary phase takes place.The main outcome measures are self-reported and accelerometer-assessed physical activity .
METHODS	Secondary outcome measures are Body Mass Index ( BMI ) , aerobic fitness and habitual physical activity .
CONCLUSIONS	This is the first study examining a dyadic action control intervention in comparison to an individual action control condition and two control groups applying a single-blind randomized control trial .
CONCLUSIONS	Challenges with running couples studies as well as advantages and disadvantages of certain design-related decisions are discussed .
CONCLUSIONS	This RCT was funded by the Swiss National Science Foundation ( PP00P1_133632 / 1 ) and was registered on 27/04/2012 at http://www.isrctn.com/ISRCTN15705531 .

###24969339
OBJECTIVE	We sought to examine changes in intraocular pressure ( IOP ) in the immediate period after clear corneal micro-incision cataract surgery ( MICS ) and after small-incision cataract surgery ( SICS ) .
METHODS	Sixty-eight eyes of 34 patients scheduled for coaxial phacoemulsification were randomized into one of two groups : ( a ) eyes that were to undergo a 2.0-mm MICS , and ( b ) a 2.65-mm SICS .
METHODS	At the conclusion of surgery , the IOP was adjusted to the range between 15-40mmHg with stromal hydration .
METHODS	The IOP was measured using a rebound tonometer preoperatively , at the conclusion of surgery , and at 3 , 6 , 9 , 12 , and 15min postoperatively .
METHODS	The Seidel test and anterior segment-optical coherence tomography were performed at 20min postoperatively .
RESULTS	Mean IOP at the conclusion of surgery was 27.74.7 mmHg in the MICS group and 29.75.1 mmHg in the SICS group ( p = 0.1239 ) .
RESULTS	In both groups , mean IOP decreased to the preoperative level within 9min postoperatively and did not change significantly for up to 15min .
RESULTS	Mean IOP was similar between the MICS and SICS groups throughout the observation period ( p0 .1239 ) .
RESULTS	Hypotony ( 10mmHg ) , positive Seidel test , and loss of wound coaptation were not detected in all eyes .
CONCLUSIONS	After adjusting the IOP to a relatively high level at the conclusion of surgery , the IOP decreased within 9min and was stable within 15min without hypotony .
CONCLUSIONS	The IOP was comparable between eyes after MICS and SICS , and both incisions virtually closed within 20min postoperatively .

###24999060
BACKGROUND	Buprenorphine/naloxone ( BUP/NX ) , an effective treatment for opioid dependence , has been implicated in hepatic toxicity .
BACKGROUND	However , as persons taking BUP/NX have multiple hepatic risk factors , comparative data are needed to quantify the risk of hepatoxicity with BUP/NX .
METHODS	We compared rates of alanine aminotransferase ( ALT ) elevationgrade 3 ( ALT5 .1 times the upper limit of normal ) and graded bilirubin elevations in HIV-negative opioid injectors randomized to long-term ( 52 weeks ) or short-term ( 18 days ) medication assisted treatment ( LT-MAT and ST-MAT , respectively ) with BUP/NX in a multisite trial conducted in China and Thailand .
METHODS	ALT and bilirubin were measured at baseline , 12 , 26 , 40 and 52 weeks , times temporally remote from BUP/NX exposure in the ST-MAT participants .
RESULTS	Among1036 subjects with at least one laboratory follow-up measurement , 76 ( 7 % ) participants experienced ALT elevationgrade 3 .
RESULTS	In an intent-to-treat analysis , the risk of ALT events was similar in participants randomized to LT-MAT compared with ST-MAT ( adjusted hazard ratio 1.25 , 95 % confidence interval 0.79 to 1.98 ) .
RESULTS	This finding was supported by an as-treated analysis , in which actual exposure to BUP/NX was considered .
RESULTS	Hepatitis C seroconversion during follow-up was strongly associated with ALT events .
RESULTS	Bilirubin elevationsgrade 2 occurred in 2 % of subjects , with no significant difference between arms .
CONCLUSIONS	Over 52-week follow-up , the risk of hepatotoxicity was similar in opioid injectors receiving brief and prolonged treatment with BUP/NX .
CONCLUSIONS	These data suggest that most hepatotoxic events observed during treatment with BUP/NX are due to other factors .

###25733632
BACKGROUND	Patients with type 1 diabetes face heightened risk of hypoglycemia after exercise .
BACKGROUND	Subsequent overfeeding , as a preventative measure against hypoglycemia , negates the energy deficit after exercise .
BACKGROUND	Patients are also required to reduce the insulin dose administered with postexercise foods to further combat hypoglycemia .
BACKGROUND	However , the insulin dose is dictated solely by the carbohydrate content , even though postprandial glycemia is vastly influenced by glycemic index ( GI ) .
BACKGROUND	With a need to control the postexercise energy balance , appetite responses after meals differing in GI are of particular interest .
OBJECTIVE	We assessed the appetite response to low-glycemic index ( LGI ) and high-glycemic index ( HGI ) postexercise meals in type 1 diabetes patients .
OBJECTIVE	This assessment also offered us the opportunity to evaluate the influence of GI on appetite responses independently of insulinemia , which confounds findings in individuals without diabetes .
METHODS	Ten physically active men with type 1 diabetes completed 2 trials in a randomized crossover design .
METHODS	After 45 min of treadmill exercise at 70 % of the peak oxygen uptake , participants consumed an LGI ( GI 37 ) or HGI ( GI 92 ) meal with a matched macronutrient composition , negligible fiber content , and standardized insulin-dose administration .
METHODS	The postprandial appetite response was determined for 180 min postmeal .
METHODS	During this time , circulating glucose , insulin , glucagon , and glucagon-like peptide-1 ( GLP-1 ) concentrations and subjective appetite ratings were determined .
RESULTS	The HGI meal produced an 60 % greater postprandial glucose area under the curve ( AUC ) than did the LGI meal ( P = 0.008 ) .
RESULTS	Insulin , glucagon , and GLP-1 did not significantly differ between trials ( P > 0.05 ) .
RESULTS	The fullness AUC was 25 % greater after the HGI meal than after the LGI meal ( P < 0.001 ) , whereas hunger sensations were 9 % lower after the HGI meal than after the LGI meal ( P = 0.001 ) .
CONCLUSIONS	Under conditions of matched insulinemia and fiber , an HGI postexercise meal suppresses feelings of hunger and augments postprandial fullness sensations more so than an otherwise equivalent LGI meal in type 1 diabetes patients .

###24835324
OBJECTIVE	This study sought to evaluate the prognostic value of routine stress myocardial perfusion scintigraphy ( MPS ) 5 years after percutaneous coronary intervention ( PCI ) .
BACKGROUND	Current appropriate use criteria define routine cardiac stress imaging < 2 years after PCI as inappropriate and > 2 years as uncertain in asymptomatic patients .
METHODS	All 339 of 683 BASKET ( Basel Stent Kosteneffektivitts Trial ) 5-year survivors ( 55 % ) consenting to undergo protocol-mandated MPS and subsequent evaluation irrespective of symptoms were followed for major adverse cardiac events ( MACE ) ( cardiac death , myocardial infarction [ MI ] , or revascularization ) .
METHODS	For MPS , summed perfusion scores were calculated and perfusion defects were related to treated-vessel or remote myocardial areas .
RESULTS	Patients were 72 10 years of age , 18 % were female , and 90 % were free of angina .
RESULTS	MPS findings were abnormal in 205 of 339 patients ( 60 % ) with complete follow-up .
RESULTS	During 3.7 0.3 years , there were 7 cardiac deaths , 18 MIs , and 47 revascularizations , resulting in a MACE rate of 4.4 % and a cardiac mortality rate of 0.6 % per year .
RESULTS	Patients with abnormal MPS findings had higher hazard ratios ( HR ) for MACE ( HR : 1.95 ; 95 % confidence interval [ CI ] : 1.06 to 3.59 ; p = 0.032 ) , and cardiac death/MI ( HR : 2.50 ; 95 % CI : 0.93 to 6.69 ; p = 0.066 ) than patients with normal MPS finding .
RESULTS	MACE rates were similar in patients with symptomatic and silent ischemia ( p = 0.61 ) but higher than in patients with normal MPS findings ( p < 0.05 for both comparisons ) .
RESULTS	MACE rates were independently predicted by remote ischemia but not by treated-vessel ischemia or scar .
CONCLUSIONS	Abnormal MPS findings 5 years after PCI are frequent irrespective of symptoms .
CONCLUSIONS	The predictive power of abnormal MPS lies more in the detection of persistent or progressing coronary artery disease in remote vessel areas than in the diagnosis of late intervention-related problems in treated vessels .

###25397819
BACKGROUND	Patients with posttraumatic stress disorder ( PTSD ) have significant medical morbidity , which may be mediated by hypothalamic pituitary axis ( HPA ) dysfunction and reflected in cortisol output .
BACKGROUND	Many veterans with PTSD are hesitant to engage in trauma-focused exposure treatments ; therefore briefer , non-exposure-based treatments are needed ; one such promising approach is an abbreviated Primary Care brief Mindfulness Program ( PCbMP ) .
OBJECTIVE	This study investigated the relationship between dose-response to participation in a veterans PCbMP program and diurnal cortisol .
OBJECTIVE	Cortisol reflects HPA function and PTSD is associated with HPA dysregulation .
METHODS	Veterans with PTSD were identified in PC and randomly assigned to treatment as usual ( TAU , n = 21 ) or participation in brief 4-week Mindfulness Based Stress Reduction program ( n = 19 ) .
METHODS	Veterans ( n = 40 ) ( mean age , 4816 y ; 90 % men ) with PTSD referred through their VA PC provider and randomly assigned to PCbMP or TAU .
METHODS	As an objective indicator of HPA function , salivary diurnal cortisol was measured from samples collected across 2 consecutive days at baseline and follow-up .
RESULTS	Analyses revealed that significant changes in cortisol were associated with PCbMP treatment engagement and dosing ( number of mindfulness program sessions completed ) .
RESULTS	Veterans completing 4 mindfulness-based meditation sessions significantly reduced their cortisol awakening response ( P0 .05 ) ; and had significant changes in cortisol area under the curve increase compared with TAU participants ( P0 .05 ) .
RESULTS	Results indicate that PCbMP has a beneficial physiological impact on veterans with PTSD with a minimum of 4 weeks of practice .

###25379549
OBJECTIVE	To compare intraocular pressure ( IOP ) measurements with the Goldmann applanation tonometer ( GAT ) and the ICare rebound tonometer ( RBT ) in high myopic eyes .
METHODS	This randomized prospective study included 40 eyes of 40 patients with high myopia .
METHODS	All patients ' central corneal thickness ( CCT ) , anterior chamber depth ( ACD ) , axial length ( AXL ) , keratometry , and refractive measurements were recorded and followed by IOP measurement with RBT and GAT .
RESULTS	The average CCT , AXL , and ACD were determined to be 514.65 32 m , 27.65 2.22 mm , and 3.25 0.51 mm , respectively .
RESULTS	Mean K was 43.27 1.4 D and mean spherical equivalent was -11.31 4.30 D.
RESULTS	The mean IOP values obtained by RBT and GAT were 17.18 3.72 mmHg and 16.48 3.19 mmHg , respectively .
RESULTS	The deviations of RBT readings from corrected GAT values were highly correlated with CCT values ( r = 0.588 , P = 0.0001 ) .
RESULTS	The mean corrected GAT reading was 17.49 3.01 mmHg .
RESULTS	Linear regression analysis showed that a CCT change of 10 m resulted in an RBT reading deviation of 0.57 mmHg .
RESULTS	The Bland-Altman scatter-plot and McNemar test showed a clinically good level of agreement between the two tonometers .
CONCLUSIONS	This study found a good agreement level between the two tonometers in high myopic patients and that RBT measurements are influenced by CCT variations .

###25491622
OBJECTIVE	To explore the clinical effectiveness of continuous blood purification ( CBP ) in combination with ulinastatin for the treatment of thermoplegia .
METHODS	Forty patients ( 28 men and 12 women ) with severe heat stroke were admitted to our hospital 's ICU department from June 2010 to August 2013 .
METHODS	The patients were randomized into a treatment group ( n = 21 ; 15 men and six women , with an average age of 32.9 years ) and control group ( n = 19 ; 13 men and six women , with an average age of 33.1 years ) .
METHODS	Patients in the control group underwent treatments of oxygen inhalation , dynamic ECG monitoring , physical cooling methods ( ice caps or ice application ) , whereas patients in the treatment group , in addition to this treatment , were further treated with continuous blood purification in combination with ulinastatin .
METHODS	During administration , the content of one vial was dissolved in 100 mL of physiological saline for intravenous dripping for 1.5 hours .
RESULTS	There were 18 cured cases , one case of sequelae of mild neurological disorders , and two deaths in the treatment group , with the cure rate of 90.48 % .
RESULTS	In comparison , there were 12 cured cases , three cases of sequelae of mild neurological disorders , and four deaths in the control group , with the cure rate of 78.95 % .
RESULTS	The overall response rates of rectal temperature drop were determined to be 95.24 % and 73.68 % for the treatment group and the control group , respectively .
RESULTS	Based on the treatment outcomes data , multiple organ dysfunction syndrome ( MODS ) recovery , deaths and survival outcomes of patients in the treatment group was more favorable than that of the control group .
RESULTS	This difference was statistically significant ( p < 0.05 ) .
CONCLUSIONS	Continuous blood purification in combination with ulinastatin is effective in treating thermoplegia and warrants further investigation .

###24401729
BACKGROUND	The potential for telehealth-based interventions to provide remote support , education and improve self-management for long-term conditions is increasingly recognised .
BACKGROUND	This trial aims to determine whether an intervention delivered through an easy-to-use tablet computer can improve the quality of life of patients with chronic obstructive pulmonary disease ( COPD ) by providing personalised self-management information and education .
METHODS	The EDGE ( sElf management anD support proGrammE ) for COPD is a multicentre , randomised controlled trial designed to assess the efficacy of an Internet-linked tablet computer-based intervention ( the EDGE platform ) in improving quality of life in patients with moderate to very severe COPD compared with usual care .
METHODS	Eligible patients are randomly allocated to receive the tablet computer-based intervention or usual care in a 2:1 ratio using a web-based randomisation system .
METHODS	Participants are recruited from respiratory outpatient clinics and pulmonary rehabilitation courses as well as from those recently discharged from hospital with a COPD-related admission and from primary care clinics .
METHODS	Participants allocated to the tablet computer-based intervention complete a daily symptom diary and record clinical symptoms using a Bluetooth-linked pulse oximeter .
METHODS	Participants allocated to receive usual care are provided with all the information given to those allocated to the intervention but without the use of the tablet computer or the facility to monitor their symptoms or physiological variables .
METHODS	The primary outcome of quality of life is measured using the St George 's Respiratory Questionnaire for COPD patients ( SGRQ-C ) baseline , 6 and 12 months .
METHODS	Secondary outcome measures are recorded at these intervals in addition to 3 months .
BACKGROUND	The Research Ethics Committee for Berkshire-South Central has provided ethical approval for the conduct of the study in the recruiting regions .
BACKGROUND	The results of the study will be disseminated through peer review publications and conference presentations .
BACKGROUND	Current controlled trials ISRCTN40367841 .

###26268058
OBJECTIVE	To evaluate the efficacy and safety of human glucagon-like peptide-1 analogue liraglutide in newly diagnosed type 2 diabetes mellitus ( T2DM ) with glycosylated hemoglobin A1c ( HbA1c ) > 9 % .
METHODS	This was an open-labelled , randomized , parallel-group , treat-to-target trial .
METHODS	Newly diagnosed T2DM patients with HbA1c > 9 % were enrolled .
METHODS	These patients were treated with metformin with repaglinide and randomized to receive once-daily liraglutide ( LIRA , n = 25 ) or the insulin glargine ( IGla , n = 24 ) at bedtime .
METHODS	Efficacy and safety were assessed and compared after 18-month treatment .
RESULTS	( 1 ) Compared with the baseline , patients with LIRA had significantly reduced mean body weight , BMI and waist circumference ( P < 0.01 ) , whereas , the above indexes were increased ( P < 0.01 ) in patients treated with IGla .
RESULTS	( 2 ) After 18 months of treatment , fasting plasma glucose ( FPG ) , 2-hour plasma glucose after a 75g oral glucose load ( 2hPG ) and HbA1c were significantly improved in all patients ( P < 0.01 ) , with 2hPG , mean blood glucose ( MBG ) , the largest amplitude of glycemic excursions ( LAGE ) , mean amplitude of glycemic excursions ( MAGE ) were significantly lower in LIRA group than in IGla group ( all P < 0.05 ) .
RESULTS	( 3 ) HOMA-IR decreased in both groups ( P < 0.05 ) .
RESULTS	However , I30/G30 , AUCCP180 and Matsuda index were only significantly increased in patients treated with LIRA ( respectively , 4.88 1.55 vs 7.601.91 , 9.23 2.66 vs 13.18 2.72 , 39.28 20.35 vs 54.64 23.34 , all P < 0.01 ) , while HOMA-IR reduced ( 4.41 1.58 vs 3.52 1.44 , P < 0.05 ) .
RESULTS	But in IGla group only HOMA-IR was reduced ( 4.92 1.84 vs 4.57 1.80 , P < 0.05 ) .
RESULTS	The index of I30/G30 , AUCCP180 and Matsuda index in LIRA group are higher than those of indexes in IGla group ( respectively , 7.60 1.91 vs 4.18 1.00 , 13.18 2.72 vs 10.53 2.68,54.64 23.34 vs 41.65 17.84 , all P < 0.05 ) , while HOMA-IR is lower ( 3.52 1.44 vs 4.57 1.80 , P < 0.05 ) .
RESULTS	( 4 ) The rate of HbA1c 6.5 % and the dosages of oral anti-diabetic drugs in LIRA group were significantly better than that in IGla group .
RESULTS	( 5 ) No significant differences were observed in hypoglycemic episodes and adverse events between two groups .
CONCLUSIONS	It seems that liraglutide is superior to insulin glargine in newly diagnosed T2DM patients with HbA1c > 9 % in improving beta-cell function , insulin sensitivity and glucose homeostasis .

###25025548
OBJECTIVE	This primary objective of this pilot randomized , controlled trial was to determine whether a brief video intervention delivered after a pediatric office visit could improve inhaler technique in children with asthma immediately and one month later .
OBJECTIVE	The intervention 's effect on children 's inhaler self-efficacy and asthma control was also evaluated .
METHODS	Children ( n = 91 ) ages 7-17 years with persistent asthma were recruited at two pediatric practices in North Carolina .
METHODS	Eligible children demonstrated their inhaler technique for metered dose inhalers ( MDIs ) either with or without a spacer .
METHODS	A trained research assistant used a validated inhaler technique checklist to record which steps children performed correctly .
METHODS	After a regularly scheduled office visit , children were randomized to watch either a 3-min MDI video ( intervention group ) or a nutrition video ( control group ) in English or Spanish .
METHODS	Children 's technique was assessed again after watching the video and one month later .
RESULTS	Children were primarily male ( 56 % ) and non-White ( 60 % ) .
RESULTS	When compared with the control group , children in the intervention group demonstrated a significant improvement in MDI technique post-intervention [ mean = 1.12 steps , 95 % CI ( 0.73 , 1.50 ) ] but the improvement was not sustained at 1-month follow-up .
RESULTS	The intervention did not lead to significant improvements in inhaler self-efficacy or asthma control .
CONCLUSIONS	A brief video intervention offered during pediatric clinic visits can lead to immediate improvements in children 's inhaler technique .
CONCLUSIONS	Future studies should evaluate whether booster training videos can help maintain improvements in children 's inhaler technique over time .

###24259599
BACKGROUND	It has been reported that dexmedetomidine ( DEX ) can be used for conscious sedation in awake craniotomy , but few data exist to compare DEX versus propofol ( PRO ) .
OBJECTIVE	To compare the efficacy and safety of DEX versus PRO for conscious sedation in awake craniotomy .
METHODS	Thirty patients of American Society of Anesthesiologists grade I-II scheduled for awake craniotomy , were randomized into 2 groups each containing 15 subjects .
METHODS	Group D received DEX and group P received PRO .
METHODS	Two minutes after tracheal intubation ( T1 ) , PRO ( target plasma concentration ) was titrated down to 1 to 4 g/mL in group P.
METHODS	In group D , PRO was discontinued and DEX was administered 1.0 g/kg followed by a maintenance dose of 0.2 to 0.7 g/kg/h .
METHODS	The surgeon preset the anticipated awake point-in-time ( T0 ) preoperatively .
METHODS	Ten minutes before T0 ( T3 ) , DEX was titrated down to 0.2 g/kg/h in group D , PRO was discontinued and normal saline ( placebo ) 5 mL/h was infused in group P. Arousal time , quality of revival and adverse events during the awake period , degree of satisfaction from surgeons and patients were recorded .
RESULTS	Arousal time was significantly shorter in group D than in group P ( P < .001 ) .
RESULTS	The quality of revival during the awake period in group D was similar to that of group P ( P = .68 ) .
RESULTS	The degree of satisfaction of surgeons was significantly higher in group D than in group P ( P < .001 ) , but no difference was found between the 2 groups with respect to patient satisfaction ( P = .80 ) .
RESULTS	There was no difference between the 2 groups in the incidence of adverse events during the awake period ( P > .05 ) .
CONCLUSIONS	Either DEX or PRO can be effectively and safely used for conscious sedation in awake craniotomy .
CONCLUSIONS	Comparing the two , DEX produced a shorter arousal time and a higher degree of surgeon satisfaction .

###24557105
BACKGROUND	In the last 2 decades , the effectiveness of cricoid pressure ( CP ) in occluding the esophageal entrance has been questioned .
BACKGROUND	Recent magnetic resonance imaging studies yielded conflicting conclusions .
BACKGROUND	We used real-time visual and mechanical means to assess the patency of the esophageal entrance with and without CP in anesthetized and paralyzed adult patients .
METHODS	One hundred seven , nonobese ASA physical status I and II patients were recruited for the study .
METHODS	A cricoid force of 30 N was used .
METHODS	This force was standardized by using a weighing scale before application of CP in each patient .
METHODS	After oxygen administration , anesthetic induction , neuromuscular blockade , and establishment of manual ventilation with FIO2 = 1.0 , the view of the glottis and esophageal entrance was visualized , and video recordings were obtained by using a Glidescope video laryngoscope .
METHODS	Attempts to insert 2 gastric tubes ( GTs ) , size 12 and 20 F , into the esophagus were made by a `` blinded '' operator without and with CP , the timing of which was randomized .
METHODS	A successful insertion of a GT in the presence of CP was considered evidence of a patent esophageal entrance ( ineffective CP ) , whereas an unsuccessful insertion of a GT was considered evidence of an occluded esophageal entrance ( effective CP ) .
METHODS	After the attempts to insert the GTs were completed , tracheal intubation was performed while CP was applied .
METHODS	The position of the esophageal entrance in relation to the glottis ( midline versus lateral ) was assessed from the video recordings , with and without CP .
RESULTS	We stopped the study when 79 patients ( 41 men and 38 women ) qualified for and completed the study ( 2-sided Clopper-Pearson confidence interval ( CI ) 95 % to 100 % , n = 72 ) .
RESULTS	Advancement of either size GT into the esophagus could not be accomplished during CP in any patient but was easily done in all subjects when CP was not applied .
RESULTS	This occurred whether the esophageal entrance was in a midline position or in a left or right lateral position relative to the glottis .
RESULTS	Esophageal patency was visually observed in the absence of CP , whereas occlusion of the esophageal entrance was observed during CP in all patients .
RESULTS	Without CP , the esophageal entrance was in a left lateral position in relation to the glottis in 57 % ( [ 95 % CI , 45 % -68 % ) ] of patients , at midline in 32 % ( CI , 22 % -43 % ) , and in a right lateral position in 11 % ( CI , 5 % -21 % ) .
RESULTS	The position did not change with CP .
CONCLUSIONS	The current study provides additional visual and mechanical evidence supporting a success rate of at least 95 % by using a cricoid force of 30 N to occlude the esophageal entrance in anesthetized and paralyzed normal adult patients .
CONCLUSIONS	The efficacy of the maneuver was independent of the position of the esophageal entrance relative to the glottis , whether midline or lateral .

###25143324
BACKGROUND	The polymorphic angiotensinogen ( AGT ) gene is one of the most promising candidates for essential hypertension .
BACKGROUND	The aim of this study was to examine the association between the A-6G variant of the AGT gene and the blood pressure response to angiotensin-converting enzyme ( ACE ) inhibitors in hypertensive subjects .
METHODS	Five hundred and nine mildly to moderately hypertensive subjects received ACE inhibitors for six weeks after a two-week run-in period .
METHODS	AGT genotyping was performed by direct polymerase chain reaction amplification and deoxyribonucleic acid ( DNA ) nucleotide sequencing from peripheral blood .
RESULTS	The AA genotype , AG genotype , and GG genotype were present in 301 ( 59.1 % ) , 186 ( 36.6 % ) , and 22 ( 4.3 % ) of patients , respectively .
RESULTS	As compared with patients carrying the AA or AG genotype , those carrying the GG genotype had significantly greater reductions in systolic blood pressure , diastolic blood pressure , pulse pressure and mean arterial pressure ( p = 0.007 , 0.014 , 0.027 and 0.005 , respectively ) .
RESULTS	Moreover , stepwise multiple linear regression analysis showed that the A-6G genotype was a significant predictor of systolic blood pressure and pulse pressure reductions ( p = 0.040 and 0.019 , respectively ) .
CONCLUSIONS	Our study indicates that the A-6G variant of the AGT gene may be an important determinant of interindividual variation in the response to ACE inhibitors .

###25074507
BACKGROUND	Contradictory results have been reported on the effects of nesiritide on renal function in patients with acute decompensated heart failure .
BACKGROUND	We studied the effects of nesiritide on renal function during hospitalization for acute decompensated heart failure and associated outcomes .
RESULTS	A total of 7141 patients were randomized to receive either nesiritide or placebo and creatinine was recorded in 5702 patients at baseline , after infusion , discharge , peak/nadir levels until day 30 .
RESULTS	Worsening renal function was defined as an increase of serum creatinine > 0.3 mg/dL and a change of 25 % .
RESULTS	Median ( 25 ( th ) -75 ( th ) percentile ) baseline creatinine was 1.2 ( 1.0-1 .6 ) mg/dL and median baseline blood urea nitrogen was 25 ( 18-39 ) mmol/L .
RESULTS	Changes in both serum creatinine and blood urea nitrogen were similar in nesiritide-treated and placebo-treated patients ( P = 0.20 and P = 0.41 ) from baseline to discharge .
RESULTS	In a multivariable model , independent predictors of change from randomization to hospital discharge in serum creatinine were a lower baseline blood urea nitrogen , higher systolic blood pressure , lower diastolic blood pressure , previous weight gain , and lower baseline potassium ( all P < 0.0001 ) .
RESULTS	The frequency of worsening renal function during hospitalization was similar in the nesiritide and placebo group ( 14.1 % and 12.8 % , respectively ; odds ratio with nesiritide 1.12 ; confidence interval , 0.95-1 .32 ; P = 0.19 ) and was not associated with death alone and death or rehospitalization at 30 days .
RESULTS	However , baseline , discharge , and change in creatinine were associated with death alone and death or rehospitalization for heart failure ( all tests , P < 0.0001 ) .
CONCLUSIONS	Nesiritide did not affect renal function in patients with acute decompensated heart failure .
CONCLUSIONS	Baseline , discharge , and change in renal function were associated with 30-day mortality or rehospitalization for heart failure .

###24277644
BACKGROUND	Activated charcoal is commonly used to manage overdose or accidental ingestion of medicines .
BACKGROUND	This study evaluated the effect of activated charcoal on apixaban exposure in human subjects .
METHODS	This was an open-label , three-treatment , three-period , randomized , crossover study of single-dose apixaban ( 20 mg ) administered alone and with activated charcoal given at 2 or 6 h post-dose to healthy subjects .
METHODS	Blood samples for assay of plasma apixaban concentration were collected up to 72 h post-dose .
METHODS	Pharmacokinetic parameters , including peak plasma concentration ( Cmax ) , time to Cmax ( Tmax ) , area under the concentration-time curve from time 0 to infinity ( AUCINF ) , and terminal half-life ( T ) , were derived from apixaban plasma concentration-time data .
METHODS	A general linear mixed-effect model analysis of Cmax and AUCINF was performed to estimate the effect of activated charcoal on apixaban exposure .
RESULTS	A total of 18 subjects were treated and completed the study .
RESULTS	AUCINF for apixaban without activated charcoal decreased by 50 and 28 % , respectively , when charcoal was administered at 2 and 6 h post-dose .
RESULTS	Apixaban Cmax and Tmax were similar across treatments .
RESULTS	The mean T for apixaban alone ( 13.4 h ) decreased to ~ 5 h when activated charcoal was administered at 2 or 6 h post-dose .
RESULTS	Overall , apixaban was well tolerated in this healthy population , and most adverse events were consistent with the known profile of activated charcoal .
CONCLUSIONS	Administration of activated charcoal up to 6 h after apixaban reduced apixaban exposure and facilitated the elimination of apixaban .
CONCLUSIONS	These results suggest that activated charcoal may be useful in the management of apixaban overdose or accidental ingestion .

###24370353
BACKGROUND	The purpose of this study was to assess the efficacy and safety of FOLFOX4 , comprising infusional 5-fluorouracil ( 5-FU ) / leucovorin ( LV ) and oxaliplatin , with cetuximab compared with UFOX , comprising UFT , an oral prodrug of 5-FU , LV , and oxaliplatin , with cetuximab as first-line treatment for mCRC .
METHODS	Patients , unselected by tumor KRAS status , were randomized 1:1 to FOLFOX4 with cetuximab or UFOX with cetuximab .
METHODS	Treatment was continued until disease progression or unacceptable toxicity .
METHODS	The primary end point , assessed in the intention-to-treat population , was progression-free survival ( PFS ) .
METHODS	Secondary end points included tumor response , overall survival , and safety .
METHODS	Outcome according to KRAS mutation status was investigated .
RESULTS	Recruitment was curtailed at 302 patients after reporting of the importance of tumor KRAS mutation status for cetuximab activity .
RESULTS	Baseline characteristics were balanced between treatment groups .
RESULTS	PFS was significantly longer in the FOLFOX4 with cetuximab group compared with UFOX with cetuximab group ( median 8.2 vs. 6.6 months ; hazard ratio , 0.68 ; 95 % confidence interval [ CI ] , 0.52-0 .89 ; P = .0048 ) .
RESULTS	The response rate was also significantly greater in the FOLFOX4 with cetuximab group ( 51.3 % vs. 37.5 % , respectively ; odds ratio , 1.76 ; 95 % CI , 1.11-2 .78 ; P = .0160 ) , although overall survival was comparable .
RESULTS	In the KRAS wild type subgroup , efficacy outcomes were similar to those in the intention-to-treat population .
RESULTS	Side effect profiles were manageable and consistent with expectations .
CONCLUSIONS	In the first-line treatment of mCRC , UFOX with cetuximab had an acceptable safety profile but inferior activity compared with FOLFOX4 with cetuximab in relation to PFS and response .
CONCLUSIONS	The regimens were comparable with regard to overall survival .

###25276983
OBJECTIVE	To observe the effect of Xingnaojing Injection combined with minimally invasive percutaneous drainage on brain edema and content of serum aquaporin-4 ( AQP4 ) in patients with moderate hypertensive basal ganglia hemorrhage , and discuss the treatment mechanism of Xingnaojing injection combined with minimally invasive percutaneous drainage for cerebral hemorrhage .
METHODS	Forty-two patients with moderate ( 25-50 mL ) hypertensive basal ganglia hemorrhage ( < 24 h ) were selected and randomly divided into two groups : the observation group ( n = 22 ) and the control group ( n = 20 ) .
METHODS	The neurological severity score were evaluated by the NIHSS ( national institutes of health stroke scale ) , the volume of brain edemas were measured by head CT , the serum levels of AQP4 were determined by ELISA method on admission and 1 and 2 weeks after treatment .
RESULTS	On admission , there was no significant difference in the scores of NIHSS , the volume of brain edemas and the level of serum AQP4 between the observation group and the control group .
RESULTS	At the end of the first week after the treatment , the score of NIHSS of the observation group were lower than that of the control group , with significant different ( P < 0.05 ) ; the observation group showed reduced volume of brain edemas than that on admission ( P < 0.05 ) , whereas the control group the control group showed increased volume of brain edemas than that on admission ; the control group displayed increased level of serum AQP4 than that on admission , but without significant difference ; the observation group displayed decreased level of serum AQP4 than that on admission ( P < 0.05 ) .
RESULTS	At the end of the second week after the treatment , the control group showed decreased score of NIHSS than that on admission and at the end of the first week after treatment ( P < 0.05 ) .
RESULTS	Compared with the control group , the observation group showed a much lower score of NIHSS ( P < 0.01 ) , the control group displayed reduced volume of brain edemas than that on admission and at the end of the first week after treatment , but the observation group was even lower than the control group .
RESULTS	Both of observation and control groups displayed significantly reduced level of AQP4 ( P < 0.05 ) , but the observation group showed a lower AQP4 level than that of the control group ( P < 0.05 ) .
CONCLUSIONS	The therapy of Xingnaojing injection combined with minimally invasive percutaneous drainage could remarkably reduce brain edema , and promote neural functional recovery , thus could be selected as a therapeutic regimen for patients with moderate hypertensive basal ganglia hemorrhage .

###25449310
OBJECTIVE	To compare the efficacy between acupuncture and ondansetron in the prevention of delayed chemotherapy induced nausea and vomiting ( CINV ) .
METHODS	70 patients were randomized to receive either 1 ) acupuncture at P6 point before chemotherapy infusion or 2 ) ondansetron 8 mg intravenously 30 min before chemotherapy infusion in their first cycle with cross-over of antiemetic regimen in the consecutive cycle .
METHODS	All patients received dexamethasone 5mg orally twice a day for 3 days .
METHODS	Patients were given additional does of ondansetron 4 mg orally every 12h if they experienced emesis .
METHODS	Emetic episode , severity of nausea score of 0-10 and adverse events were recorded .
METHODS	Complete response was defined as no nausea , no vomiting and no requirement of additional antiemetic drugs .
METHODS	FACT-G scale was used to evaluate quality of life ( QOL ) 7 days after each cycle of chemotherapy .
RESULTS	The acupuncture group had a significantly higher rate of complete response in the prevention of delayed CINV ( 52.8 % and 35.7 % , P = 0.02 ) .
RESULTS	Compared to another group , the acupuncture group reported significantly lower delayed nausea ( 45.7 % and 65.7 % , P = 0.004 ) , nausea score ( P < 0.001 ) and fewer dosages of additional oral ondansetron ( P = 0.002 ) .
RESULTS	Adverse effects were also significantly lower in the acupuncture group with less frequent constipation ( P = 0.02 ) and insomnia ( P = 0.01 ) .
RESULTS	Overall FACT-G scores were significantly higher in the acupuncture group .
CONCLUSIONS	Acupuncture is effective in preventing delayed CINV and in promoting better QOL .
CONCLUSIONS	With fewer adverse effects , it may be used as an alternative treatment option for CINV .

###24251579
OBJECTIVE	The aim of this study was to assess associations between patient characteristics , intensification of blood glucose-lowering treatment through oral glucose-lowering therapy and/or insulin and effective glycaemic control in type 2 diabetes .
METHODS	11140 patients from the Action in Diabetes and Vascular disease : preterAx and diamicroN-MR Controlled Evaluation ( ADVANCE ) trial who were randomized to intensive glucose control or standard glucose control and followed up for a median of 5years were categorized into two groups : effective glycaemic control [ haemoglobin A1c ( HbA1c ) 7.0 % or a proportionate reduction in HbA1c over 10 % ] or ineffective glycaemic control ( HbA1c > 7.0 % and a proportionate reduction in HbA1c less than or equal to 10 % ) .
METHODS	Therapeutic intensification was defined as addition of an oral glucose-lowering agent or commencement of insulin .
METHODS	Pooled logistic regression models examined the associations between patient factors , intensification and effective glycaemic control .
RESULTS	A total of 7768 patients ( 69.7 % ) , including 3198 in the standard treatment group achieved effective glycaemic control .
RESULTS	Compared to patients with ineffective control , patients with effective glycaemic control had shorter duration of diabetes and lower HbA1c at baseline and at the time of treatment intensification .
RESULTS	Treatment intensification with addition of an oral agent or commencement of insulin was associated with a 107 % [ odds ratio , OR : 2.07 ( 95 % confidence interval , CI : 1.95-2 .20 ) ] and 152 % [ OR : 2.52 ( 95 % CI : 2.30-2 .77 ) ] greater chance of achieving effective glycaemic control , respectively .
RESULTS	These associations were robust after adjustment for several baseline characteristics and not modified by the number of oral medications taken at the time of treatment intensification .
CONCLUSIONS	Effective glycaemic control was associated with treatment intensification at lower HbA1c levels at all stages of the disease course and in both arms of the ADVANCE trial .

###24919569
OBJECTIVE	Panitumumab , a fully human anti-epidermal growth factor receptor monoclonal antibody ( mAb ) , has demonstrated efficacy in patients with wild-type KRAS metastatic colorectal cancer ( mCRC ) .
OBJECTIVE	Rilotumumab and ganitumab are investigational , fully human mAbs against hepatocyte growth factor ( HGF ) / scatter factor and IGF1R , respectively .
OBJECTIVE	Here we evaluate combining rilotumumab or ganitumab with panitumumab in previously treated patients with wild-type KRAS mCRC .
METHODS	Part 1 was a phase Ib dose-finding study of panitumumab plus rilotumumab .
METHODS	The primary endpoint was the incidence of dose-limiting toxicities ( DLT ) .
METHODS	Part 2 was a randomized phase II trial of panitumumab in combination with rilotumumab , ganitumab , or placebo .
METHODS	The primary endpoint was objective response rate ( ORR ) ; safety , progression-free survival ( PFS ) , and overall survival ( OS ) were secondary endpoints .
METHODS	Archival tissue specimens were collected for exploratory correlative work .
RESULTS	In part 1 , no DLTs were reported .
RESULTS	A recommended phase II dose of 10 mg/kg rilotumumab was selected .
RESULTS	In part 2 , for the panitumumab plus rilotumumab ( n = 48 ) , panitumumab plus ganitumab ( n = 46 ) , and panitumumab plus placebo arms ( n = 48 ) , the ORRs were 31 % , 22 % , and 21 % , respectively .
RESULTS	The median PFS was 5.2 , 5.3 , and 3.7 months and median OS 13.8 , 10.6 , and 11.6 months , respectively .
RESULTS	Adverse events were tolerable .
RESULTS	Exploratory biomarker analyses , including MET and IGF-related protein expression , failed to indicate conclusive predictive evidence on efficacy endpoints .
CONCLUSIONS	Panitumumab plus rilotumumab met the prespecified criterion for improvement in ORR whereas ganitumab did not .
CONCLUSIONS	This is the first study to suggest a benefit for combining an HGF inhibitor ( rilotumumab ) with panitumumab in previously treated patients with wild-type KRAS mCRC .

###25325892
OBJECTIVE	To evaluate femtosecond laser-assisted and manual clear corneal incisions and their effect on surgically induced astigmatism ( SIA ) and corneal higher-order aberrations ( HOAs ) .
METHODS	In a prospective randomized study , conventional phacoemulsification with a 2.8-mm clear corneal incision using a disposable keratome was performed in 20 eyes of 20 patients ( manual group ) , and femtosecond laser-assisted cataract surgery with a 2.8-mm biplanar clear corneal tunnel created by a femtosecond laser ( LenSx ; Alcon Laboratories , Inc. , Aliso Viejo , CA ) was performed in 20 eyes of 20 patients ( femtosecond laser group ) .
METHODS	Corneal topography readings and corneal wavefront aberrations ( diameter : 9.0 mm ) were obtained using a Scheimpflug camera ( Pentacam HR ; Oculus Optikgerate , Wetzlar , Germany ) preoperatively and 3 months postoperatively .
RESULTS	There was no significant difference in SIA between the groups ( femtosecond laser group : 0.47 0.13 vs manual group : 0.41 0.14 ; P = .218 ) , but the axis deviation of the SIA axis from the previously planned axis was significantly smaller in the femtosecond laser group compared to the manual group ( 4.47 2.59 vs 7.38 4.72 , respectively ; P = .048 ) .
RESULTS	Corneal HOAs increased significantly in both groups ( femtosecond laser group : 0.13 0.09 to 0.18 0.12 , P = .025 ; manual group : 0.13 0.05 to 0.15 0.05 , P = .002 ) , but preoperative and postoperative values did not differ significantly between them ( P = .472 and .078 , respectively ) .
RESULTS	Lower-order and total corneal aberration values remained stable in both groups ( P > .05 ) .
CONCLUSIONS	There was no difference in SIA and induced HOAs between manual and femtosecond laser-created clear corneal incisions .

###25491618
OBJECTIVE	Opioid-induced hyperalgesia is well known complication of acute high dose and chronic opioid therapy .
OBJECTIVE	In this study , we evaluated development of opioid-induced hyperalgesia following intraoperative short-term use of - opioid agonist fentanyl after coronary artery bypass surgery .
METHODS	100 patients undergoing elective coronary artery bypass graft surgery is divided into two groups .
METHODS	In group I ( low dose ) , anesthesia was induced with propofol 1-2 .5 mg/kg and fentanyl 2 mcg/kg , in group II ( high dose ) fentanyl 40-70 mcg/kg was used .
METHODS	In group I , propofol 5-10 mg/kg/h , fentanyl 1-3 mcg/kg/h , in group II fentanyl 5-10 mcg/kg/h was used for maintenance of anesthesia .
METHODS	The tactile and thermal thresholds were measured before surgery and in 1st , 3rd and 7th postoperative days by using Von Frey filaments and a thermal source , respectively .
RESULTS	Tactile thresholds were significantly decreased at the first ( 6,080.21 and 3.760.13 g ; p < 0.001 ) and third ( 6.760.24 and 4.960.16 g ; p < 0.001 ) postoperative days compared to baseline preoperative values ( 7.720.26 , and 7.600.21 g ; p = 816 ) in two groups .
RESULTS	Postoperative 1st ( 13.450.33 and 10.050.24 sec ; p < 0.001 ) and 3rd day ( 14.770.28 and 13.170.26 sec ; p < 0.001 ) assessments showed a statistically significant thermal hyperalgesia compared to the preoperative baseline values ( 16.670.51 and 16.450.42 sec ; p = 0.997 ) in two groups .
RESULTS	This decrease in both tactile and thermal thresholds returned to baseline control values at the 7th day of measurement .
CONCLUSIONS	Our results showed that patients undergoing coronary artery bypass surgery receiving fentanyl anesthesia developed postoperative tactile allodynia and thermal hyperalgesia and this was more prominent in high dose group .

###24517110
OBJECTIVE	Rates of preventive asthma care after an asthma emergency department ( ED ) visit are low among inner-city children .
OBJECTIVE	The objective of this study was to test the efficacy of a clinician and caregiver feedback intervention ( INT ) on improving preventive asthma care following an asthma ED visit compared to an attention control group ( CON ) .
METHODS	Children with persistent asthma and recent asthma ED visits ( N = 300 ) were enrolled and randomized into a feedback intervention or an attention control group and followed for 12 months .
METHODS	All children received nurse visits .
METHODS	Data were obtained from interviews , child salivary cotinine levels and pharmacy records .
METHODS	Standard t-test , chi-square and multiple logistic regression tests were used to test for differences between the groups for reporting greater than or equal to two primary care provider ( PCP ) preventive care visits for asthma over 12 months .
RESULTS	Children were primarily male , young ( 3-5 years ) , African American and Medicaid insured .
RESULTS	Mean ED visits over 12 months was high ( 2.29 visits ) .
RESULTS	No difference by group was noted for attending two or more PCP visits/12 months or having an asthma action plan ( AAP ) .
RESULTS	Children having an AAP at baseline were almost twice as likely to attend two or more PCP visits over 12 months while controlling for asthma control , group status , child age and number of asthma ED visits .
CONCLUSIONS	A clinician and caregiver feedback intervention was unsuccessful in increasing asthma preventive care compared to an attention control group .
CONCLUSIONS	Further research is needed to develop interventions to effectively prevent morbidity in high risk inner-city children with frequent ED utilization .

###24767423
BACKGROUND	The New Forest Parenting Programme ( NFPP ) is a home-delivered , evidence-based parenting programme to target symptoms of attention-deficit/hyperactivity disorder ( ADHD ) in preschool children .
BACKGROUND	It has been adapted for use with ` hard-to-reach ' or ` difficult-to-treat ' children .
BACKGROUND	This trial will compare the adapted-NFPP with a generic parenting group-based programme , Incredible Years ( IY ) , which has been recommended for children with preschool-type ADHD symptoms .
METHODS	This multicentre randomized controlled trial comprises three arms : adapted-NFPP , IY and treatment as usual ( TAU ) .
METHODS	A sample of 329 parents of preschool-aged children with a research diagnosis of ADHD enriched for hard-to-reach and potentially treatment-resistant children will be allocated to the arms in the ratio 3:3:1 .
METHODS	Participants in the adapted-NFPP and IY arms receive an induction visit followed by 12 weekly parenting sessions of 1hours ( adapted-NFPP ) or 2hours ( IY ) over 2.5 years .
METHODS	Adapted-NFPP will be delivered as a one-to-one home-based intervention ; IY , as a group-based intervention .
METHODS	TAU participants are offered a parenting programme at the end of the study .
METHODS	The primary objective is to test whether the adapted-NFPP produces beneficial effects in terms of core ADHD symptoms .
METHODS	Secondary objectives include examination of the treatment impact on secondary outcomes , a study of cost-effectiveness and examination of the mediating role of treatment-induced changes in parenting behaviour and neuropsychological function .
METHODS	The primary outcome is change in ADHD symptoms , as measured by the parent-completed version of the SNAP-IV questionnaire , adjusted for pretreatment SNAP-IV score .
METHODS	Secondary outcome measures are : a validated index of behaviour during child 's solo play ; teacher-reported SNAP-IV ( ADHD scale ) ; teacher and parent SNAP-IV ( ODD ) Scale ; Eyberg Child Behaviour Inventory - Oppositional Defiant Disorder scale ; Revised Client Service Receipt Inventory - Health Economics Costs measure and EuroQol ( EQ5D ) health-related quality-of-life measure .
METHODS	Follow-up measures will be collected 6months after treatment for participants allocated to adapted-NFPP and IY .
CONCLUSIONS	This trial will provide evidence as to whether the adapted-NFPP is more effective and cost-effective than the recommended treatment and TAU .
CONCLUSIONS	It will also provide information about mediating factors ( improved parenting and neuropsychological function ) and moderating factors ( parent and child genetic factors ) in any increased benefit .
BACKGROUND	Current Controlled Trials , ISRCTN39288126 .

###25569591
BACKGROUND	Approximately 30 % of all bone injuries are foot metatarsal fractures .
BACKGROUND	Metatarsal V basis fractures occur most frequently .
BACKGROUND	The classification is done into the tuberosity avulsion fractures , Jones fractures and stress fractures of the proximal diaphysis .
BACKGROUND	The treatments of non-displaced fractures are generally conservative .
BACKGROUND	The indication for surgical treatment depends on the load and the associated refracture rate .
BACKGROUND	There are different types of treatment of these fractures .
BACKGROUND	We present a possible approach to conservative treatments and show how different therapies affect healing of metatarsal V basis fractures and social reintegration of patients .
METHODS	A retrospective study consisted of 68 patients analysed during a 9-year period , whereas for a prospective analysis 18 patients were included for a period of 3 years .
METHODS	The treatment was performed using either a splint , closed bandage of theankle or special Gttinger Anklesplint bandage , with immediate pain-oriented full load in all groups .
METHODS	The subjective and objective treatment results were analysed accoding the Gttinger Phillips score .
RESULTS	In retrospect , the fracture consolidation was observed after 8.1 weeks full load-bearing was achieved after 6.3 weeks on average .
RESULTS	In the prospective analysis , the osseous consolidation occurred after 6.2 weeks , and the full load was applied after 1.7 weeks .
RESULTS	After 10 weeks the treatment with the Anklesplint bandage was assessed with 105 points of a maximum 110 points of the Phillips score .
RESULTS	The Anklesplint bandage was also the cheapest option in the cost comparison .
CONCLUSIONS	Using the immobilisation of the metatarsal supination with the Anklesplint bandage the metatarsal V basis fractures can heal in a regular way .
CONCLUSIONS	The functional outcome is better in comparison to the that with other treatments and it is a cost-effective treatment .

###24491414
BACKGROUND	Epidural administration of dexamethasone might reduce postoperative pain in adults .
BACKGROUND	We evaluated whether a caudal block of 0.1 mg kg ( -1 ) dexamethasone combined with ropivacaine improves analgesic efficacy in children undergoing day-case orchiopexy .
METHODS	This randomized , double-blind study included 80 children aged 6 months to 5 yr who underwent day-case , unilateral orchiopexy .
METHODS	Patients received either 1.5 ml kg ( -1 ) of 0.15 % ropivacaine ( Group C ) or 1.5 ml kg ( -1 ) of 0.15 % ropivacaine in which dexamethasone of 0.1 mg kg ( -1 ) was mixed ( Group D ) for caudal analgesia .
METHODS	Postoperative pain scores , rescue analgesic consumption , and side-effects were evaluated 48 h after operation .
RESULTS	Postoperative pain scores at 6 and 24 h post-surgery were significantly lower in Group D than in Group C. Furthermore , the number of subjects who remained pain free up to 48 h after operation was significantly greater in Group D [ 19 of 38 ( 50 % ) ] than in Group C [ four of 37 ( 10.8 % ) ; P < 0.001 ] .
RESULTS	The number of subjects who received oral analgesic was significantly lower in Group D [ 11 of 38 ( 28.9 % ) ] than in Group C [ 20 of 37 ( 54.1 % ) ; P = 0.027 ] .
RESULTS	Time to first oral analgesic administration after surgery was also significantly longer in Group D than in Group C ( P = 0.014 ) .
RESULTS	Adverse events after surgery including vomiting , fever , wound infection , and wound dehiscence were comparable between the two groups .
CONCLUSIONS	The addition of dexamethasone 0.1 mg kg ( -1 ) to ropivacaine for caudal block can significantly improve analgesic efficacy in children undergoing orchiopexy .
CONCLUSIONS	Clinical trial registration NCT01604915 .

###24885816
BACKGROUND	Gastrointestinal ( GI ) discomfort , e.g. bloating or rumbling , is a common symptom in otherwise healthy adults .
BACKGROUND	Approximately 20 % of the population , particularly women suffer from gastrointestinal discomfort and this affects quality of life .
BACKGROUND	Recent studies discovered a link between the body and mind , called the gut-brain axis .
BACKGROUND	Psychosocial factors , such as e.g. daily stress may cause altered gut physiology leading to ileum contractions and consequently gastrointestinal symptoms .
BACKGROUND	In vitro and ex vivo studies clearly showed that a Perilla frutescens extract combines prokinetic , antispasmodic and anti-inflammatory effects .
BACKGROUND	The aim of the intervention was to investigate the effects of the proprietary Perilla extract on GI discomfort in healthy subjects with gastrointestinal discomfort and reduced bowel movements in comparison to a placebo product .
METHODS	The pilot study was performed according to a double-blind , randomized , placebo-controlled parallel design .
METHODS	Fifty healthy subjects with gastrointestinal discomfort and reduced bowel movements , 30-70 years , documented their GI symptoms , stool frequency and consistency daily during a 2-week run-in phase and a 4-week intervention phase with Perilla frutescens extract or placebo .
METHODS	GI symptoms were assessed on a 5-point scale daily and average scores over 14 days intervals were calculated .
RESULTS	All GI symptoms were significantly improved over time by Perilla frutescens extract during the intervention phase ( bloating : -0.440.56 , p = 0.0003 ; passage of gas : -0.300.66 , p = 0.0264 ; GI rumbling : -0.550.87 , p = 0.0014 ; feeling of fullness : -0.360.72 , p = 0.0152 ; abdominal discomfort : -0.540.75 , p = 0.004 ) , whereas in the placebo group only abdominal discomfort was significantly improved ( -0.310.55 , p = 0.0345 ) .
RESULTS	In the subgroup of women results were strengthened and a subscore out of bloating and abdominal discomfort was significantly improved against placebo ( 95 % CI 0.003 to 0.77 ; p = 0.048 ) .
CONCLUSIONS	The demonstrated effects of Perilla frutescens extract to improve GI complaints offer very promising results , taking into consideration the challenging set up of a nutritional human study with healthy subjects and in the area of digestive health , which is known for high placebo effects .
BACKGROUND	NCT01931930 at ClinicalTrials.gov , Registration date 23rd August 2013 .

###24325472
BACKGROUND	Atherosclerosis is a postprandial phenomenon .
BACKGROUND	The balanced n-6 / n-3 PUFA ratio contributing to the prevention of atherosclerosis has been well shown , but the effect of the ratio on postprandial metabolism has not been fully investigated .
BACKGROUND	The aim of this study was to investigate the effects of the n-6 / n-3 PUFAs ratio on postprandial metabolism in hypertriacylglycerolemia patients , comparing them to healthy controls .
METHODS	Test meals with 0.97 ( high n-3 ) and 8.80 ( low n-3 ) n-6 / n-3 PUFAs ratio were administered in a randomized crossover design to 8 healthy and 8 hypertriacylglycerolemia subjects .
METHODS	Blood samples were collected for 8 hours after meals to measure triglyceride ( TG ) , total cholesterol ( TC ) , HDL , ApoA , ApoB , glucose , insulin , inflammatory makers including tumor necrosis factor alpha ( TNF - ) and interleukin-6 ( IL-6 ) , endothelial function including nitric oxide ( NO ) and endothelin-1 ( ET-1 ) .
RESULTS	According to repeated-measures ANOVA , the postprandial response of lipid , glucose , insulin , inflammation and endothelial function were not significantly different between meals .
RESULTS	The postprandial TG and NO response were significantly different between healthy control ( HC ) and hypertriglyceridemia group ( HTG ) after both meals ( P < 0.01 ) .
RESULTS	After both meals maximal change and iAUC for TG was all higher in HTG group than HC group , the difference was significant after low n-3 meal but not after high n-3 meal .
RESULTS	The concentration of glucose , insulin , IL-6 , TNF and ET-1 at each time point was higher and NO was lower in HTG group , but the maximal change and iAUC had no significant difference except for iAUC of insulin , IL-6 and diAUC of NO after low n-3 meal .
CONCLUSIONS	The ratio of n-6 and n-3 maybe do not acutely influence the postprandial metabolism , inflammatory response and endothelial function , but the low n-3 meal can strengthen the difference between HTG and HC group .

###25633090
BACKGROUND	Severe asthma is a major public health issue throughout the world .
BACKGROUND	Increased bronchial smooth muscle ( BSM ) mass , a characteristic feature of airway remodeling in severe asthma , is associated with resistance to high-intensity treatment and poor prognosis .
BACKGROUND	In vitro , the Ca ( 2 + ) - channel blocker gallopamil decreased the proliferation of BSM cells from patients with severe asthma .
OBJECTIVE	We conducted a double-blind , randomized , placebo-controlled study to evaluate the effect of gallopamil on airway remodeling in patients with severe asthma .
METHODS	Subjects received either gallopamil ( n = 16 ) or placebo ( n = 15 ) for 1 year and were monitored for an additional 3-month period .
METHODS	Airway remodeling was analyzed at baseline and after treatment phase using both fiberoptic bronchoscopy and computed tomography scan .
METHODS	The primary end point was the BSM area .
METHODS	Secondary end points included normalized BSM thickness and frequency of asthma exacerbations .
RESULTS	BSM area was reduced in the gallopamil group ( baseline vs. end of treatment ) but was unchanged in the placebo group .
RESULTS	Between-group differences in BSM area were not significantly different in gallopamil versus placebo groups .
RESULTS	By contrast , between-group differences in normalized BSM thickness were significantly different between the two groups .
RESULTS	The mean number of exacerbations per month was not different during the treatment phase in gallopamil versus placebo group but was significantly lower in patients previously treated with gallopamil during the follow-up period .
RESULTS	There were no differences between the groups with respect to overall side effects .
CONCLUSIONS	Gallopamil treatment for 12 months reduces BSM remodeling and prevents the occurrence of asthma exacerbations .
CONCLUSIONS	Clinical trial registered with www.clinicaltrials.gov ( NCT 00896428 ) .

###24513239
BACKGROUND	Previous studies have demonstrated variable patterns of longitudinal septal deformation in patients with left ventricular ( LV ) dysfunction and left bundle branch block .
BACKGROUND	This prospective single center study was designed to assess the relationship between septal deformation patterns obtained by two-dimensional speckle-tracking echocardiography and response to cardiac resynchronization therapy ( CRT ) .
METHODS	One hundred one patients with New York Heart Association class II to IV heart failure , LV ejection fractions 35 % , and left bundle branch block underwent echocardiography before CRT .
METHODS	Longitudinal two-dimensional speckle-tracking strain analysis in the apical four-chamber view identified three patterns : double-peaked systolic shortening ( pattern 1 ) , early pre-ejection shortening peak followed by prominent systolic stretch ( pattern 2 ) , and pseudonormal shortening with a late systolic shortening peak and less pronounced end-systolic stretch ( pattern 3 ) .
METHODS	CRT response was defined as a relative reduction in LV end-systolic volume of 15 % at 9-month follow-up .
METHODS	CRT super-response was defined as an absolute LV ejection fraction of 50 % associated with a relative reduction in LV end-systolic volume of 15 % and an improvement in New York Heart Association functional class .
METHODS	Cardiac death or hospitalization for heart failure during follow-up was systematically investigated .
RESULTS	Ninety-two percent of patients with pattern 1 or 2 were responders to CRT compared with 59 % with pattern 3 ( P < .0001 ) .
RESULTS	Thirty-six percent of patients with pattern 1 were super-responders compared with 15 % of those with pattern 2 and 12 % of those with pattern 3 ( P = .037 ) .
RESULTS	The improvement in LV volumes , LV ejection fraction , and global longitudinal strain after CRT was better in patients with pattern 1 or 2 compared with those with pattern 3 ( P < .0001 for all ) .
RESULTS	Eighteen-month outcomes were excellent in patients with pattern 1 or 2 , with event-free survival of 95 3 % compared with 75 7 % in patients with pattern 3 ( P = .010 ) .
CONCLUSIONS	Septal deformation strain pattern 1 or 2 is highly predictive of CRT response .
CONCLUSIONS	Further studies are needed to identify predictors of `` nonresponse '' in patients with a pattern 3 .

###25122975
OBJECTIVE	The purpose of this study was to determine the plaque-reducing effectiveness of two new powered toothbrushes and compare them to a manual toothbrush control .
METHODS	This examiner-blind , randomized study used a crossover design .
METHODS	Sixty-five qualifying male and female subjects were randomly assigned one of the two test powered brushes ( Spinbrush Truly Radiant Deep Clean [ TRDC ] or Spinbrush Truly Radiant Extra Whitening [ TREW ] , Church & Dwight Co. , Inc. , Princeton , NJ , USA ) or an ADA standard manual toothbrush ( MT ; American Dental Association , Chicago , IL , USA ) according to one of three computer-generated sequences .
METHODS	Following instruction in the use of their assigned toothbrush , subjects brushed at home with a standard fluoride toothpaste twice daily for two minutes during a one-week familiarization period .
METHODS	At the end of this period , the subjects returned to the study site after refraining from oral hygiene for 12-16 hours , and from eating , drinking , and smoking for four hours .
METHODS	Plaque was scored using the Rustogi Modification of the Navy Plaque Index .
METHODS	Subjects brushed under supervision with their assigned toothbrush for two minutes , and plaque was rescored .
METHODS	They were then given one of the alternate toothbrushes according to their assigned sequence , and the familiarization routine and evaluation processes were repeated until each of the subjects used each of the three brushes .
RESULTS	Within-group analyses showed that all three toothbrushes produced statistically significant reductions from the pre-brushing baseline in whole mouth and regional plaque scores ( p < 0.001 ) , with respective whole mouth reductions of 17.9 % , 42.3 % , and 38.1 % for MT , TRDC , and TREW .
RESULTS	Between-group analyses showed that TRDC and TREW were each significantly more effective ( p < 0.001 ) than MT , as each showed at least twice as much of a reduction in whole mouth scores .
RESULTS	Both of the powered brushes also produced statistically significantly greater reductions than the manual brush at each of the twelve subsets of sites examined , with the greatest differences at interpoximal sites and sites presenting access difficulty , such as those in the lingual posterior region .
RESULTS	Additionally , TRDC produced a statistically significant 11.5 % greater reduction than TREW ( p = 0.001 ) in whole mouth plaque scores , and statistically significantly greater reductions in two of the subsets evaluated .
CONCLUSIONS	Both of the powered brushes tested proved to be safe and significantly more effective than the standard manual control brush in reducing plaque .
CONCLUSIONS	While the finding that the TRDC was significantly more effective than the TREW in reducing whole mouth plaque and plaque in two subsets demonstrates that small differences in toothbrush design may impact performance , longer-term studies would be needed to assess the extent to which this translates to meaningful clinical outcomes .

###24515544
OBJECTIVE	This study 's aims were to detect and quantify bacterial DNA in the urine of randomized trial participants about to undergo treatment for urinary urgency incontinence ( UUI ) without clinical evidence of urinary tract infection ( UTI ) and to determine if the presence of bacterial DNA in baseline urine relates to either baseline urinary symptoms or UTI risk after urinary tract instrumentation .
METHODS	Women without clinical evidence of baseline UTI were randomized to cystoscopic onabotulinum toxin A injection and oral placebo medication versus cystoscopic placebo injection and active oral medication .
METHODS	Bacterial DNA in participants ' catheterized urine was measured by quantitative polymerase chain reaction ( qPCR ) .
RESULTS	Bacterial DNA was detected in the urine of 38.7 % of participants ( 60 out of 155 ) .
RESULTS	In these 60 qPCR-positive participants , baseline daily UUI episodes were greater than in the 95 qPCR-negative participants ( 5.71 [ 2.60 ] vs 4.72 [ 2.86 ] , p = 0.004 ) .
RESULTS	Neither symptom severity by questionnaire nor treatment outcome was associated with qPCR status or with qPCR level in qPCR-positive subjects .
RESULTS	In contrast , the presence of urinary bacterial DNA was associated with UTI risk : only 10 % of the qPCR-positive women developed a UTI post-treatment , while 24 % of the qPCR-negative women did so .
RESULTS	The median qPCR level for qPCR-positive samples did not differ significantly by UTI status ( UTI 2.5810 ( 5 ) vs no UTI 1.3510 ( 5 ) copies/mL , p = 0.6 ) .
CONCLUSIONS	These results may indicate a urinary bacterial contribution to both baseline UUI and the risk of post-treatment UTI .

###24565128
OBJECTIVE	The increased intraocular pressure ( IOP ) - which decreases perfusion pressure on the optic nerve - increases by prone positioning ( 1 ) .
OBJECTIVE	The aim of our study was to compare the effect of head rotation 45 laterally in prone position on the increase in IOP of upper placed and lower placed eyes in patients undergoing percutaneous nephrolithotomy ( PCNL ) .
METHODS	Forty-five patients were randomly divided into 2 Groups .
METHODS	IOP of the patients were recorded bilaterally in supine position before the operation had started .
METHODS	Patients were turned to prone position .
METHODS	The head was placed on a prone headrest without external direct compression to both eyes .
METHODS	Patients in Group I were kept in strictly neutral prone position where as patients in Group II were placed prone with their heads rotated 45 laterally to the right side .
METHODS	At the end of the operation , patients were turned to supine position and their IOP was measured immediately .
RESULTS	There was no difference related to demographics , duration of surgery , blood loss and fluid input data .
RESULTS	IOP values after surgery in prone position increased significantly compared to preoperative values in both groups ( p < 0.05 ) .
RESULTS	After surgery in prone position IOP values of the upper positioned eyes in Group II were significantly lower than Group I and lower positioned eyes in Group II ( p < 0.05 ) .
CONCLUSIONS	prone positioning increases IOP .
CONCLUSIONS	In patients with prone position with a head rotation of 45 laterally , IOP in the upper positioned eye was significantly lower .

###24993861
BACKGROUND	It is estimated that about 275,000 inhabitants experience an out-of-hospital cardiac arrest ( OHCA ) every year in Europe .
BACKGROUND	Survival in out-of-hospital cardiac arrest is relatively low , generally between five per cent and 10 % .
BACKGROUND	Being able to explore new methods to improve the relatively low survival rate is vital for people with these conditions .
BACKGROUND	Passive leg raise ( PLR ) during cardiopulmonary resuscitation ( CPR ) has been found to improve cardiac preload and blood flow during chest compressions .
BACKGROUND	The aim of our study is to evaluate whether early PLR during CPR also has an impact on one-month survival in sudden and unexpected out-of-hospital cardiac arrest ( OHCA ) .
METHODS	A prospective , randomized , controlled trial in which all patients ( 18years ) receiving out-of hospital CPR are randomized by envelope to be treated with either PLR or in the flat position .
METHODS	The ambulance crew use a special folding stool which allows the legs to be elevated about 20 degrees .
METHODS	Primary end-point : survival to one month .
METHODS	Secondary end-point : survival to hospital admission to one month and to one year with acceptable cerebral performance classification ( CPC ) 1-2 .
CONCLUSIONS	PLR is a simple and fast maneuver .
CONCLUSIONS	We believe that the greatest benefit with PLR is when performed early in the process , during the first minutes of CPR and before the first defibrillation .
CONCLUSIONS	To reach power this study need 3000 patients , we hope that this method article will encourage other sites to contact us and take part in our study .
BACKGROUND	ClinicalTrials.gov NCT01952197 .

###24914429
OBJECTIVE	To investigate the possibility of influencing adolescents ' caries incidence , knowledge and attitudes to oral health and tobacco through a school-based oral health intervention programme .
METHODS	Four schools in a county in Sweden were randomised to one intervention and one control group .
METHODS	At the intervention schools , two dental hygienists worked 4 h every week for two years .
METHODS	Health education and preventive measures , such as fluoride varnish treatments every 6 months , were performed .
METHODS	The control group had no intervention .
METHODS	The study included a total of 534 participants aged 12-16 years .
METHODS	Outcome variables of the study were 1 ) caries incidence assessed on bite-wing radiographs and 2 ) knowledge and attitudes measured through questionnaires .
RESULTS	The intervention programme impacted on the incidence of enamel caries , while no effect on dentin caries could be seen .
RESULTS	Data from the questionnaires showed that the adolescents considered their teeth as important .
RESULTS	Adolescents in the intervention group had better knowledge about oral health and oral hygiene compared to the control group after the two years , but no impact on attitudes toward tobacco could be seen .
RESULTS	A majority of the adolescents were positive to the education about oral health and tobacco and they believed that the dental hygienists would help them improve their oral health .
CONCLUSIONS	Although the effects of the intervention as regards to caries incidence , knowledge and attitudes were limited , the presence of dental hygienists in school was appreciated by the adolescents and seemed to increase their interest in their oral health .

###25493974
BACKGROUND	Traumatic brain injury ( TBI ) is a major cause of death and disability worldwide .
BACKGROUND	Progesterone has been shown to improve neurologic outcome in multiple experimental models and two early-phase trials involving patients with TBI .
METHODS	We conducted a double-blind , multicenter clinical trial in which patients with severe , moderate-to-severe , or moderate acute TBI ( Glasgow Coma Scale score of 4 to 12 , on a scale from 3 to 15 , with lower scores indicating a lower level of consciousness ) were randomly assigned to intravenous progesterone or placebo , with the study treatment initiated within 4 hours after injury and administered for a total of 96 hours .
METHODS	Efficacy was defined as an increase of 10 percentage points in the proportion of patients with a favorable outcome , as determined with the use of the stratified dichotomy of the Extended Glasgow Outcome Scale score at 6 months after injury .
METHODS	Secondary outcomes included mortality and the Disability Rating Scale score .
RESULTS	A total of 882 of the planned sample of 1140 patients underwent randomization before the trial was stopped for futility with respect to the primary outcome .
RESULTS	The study groups were similar with regard to baseline characteristics ; the median age of the patients was 35 years , 73.7 % were men , 15.2 % were black , and the mean Injury Severity Score was 24.4 ( on a scale from 0 to 75 , with higher scores indicating greater severity ) .
RESULTS	The most frequent mechanism of injury was a motor vehicle accident .
RESULTS	There was no significant difference between the progesterone group and the placebo group in the proportion of patients with a favorable outcome ( relative benefit of progesterone , 0.95 ; 95 % confidence interval [ CI ] , 0.85 to 1.06 ; P = 0.35 ) .
RESULTS	Phlebitis or thrombophlebitis was more frequent in the progesterone group than in the placebo group ( relative risk , 3.03 ; CI , 1.96 to 4.66 ) .
RESULTS	There were no significant differences in the other prespecified safety outcomes .
CONCLUSIONS	This clinical trial did not show a benefit of progesterone over placebo in the improvement of outcomes in patients with acute TBI .
CONCLUSIONS	( Funded by the National Institute of Neurological Disorders and Stroke and others ; PROTECT III ClinicalTrials.gov number , NCT00822900 . )

###24521841
BACKGROUND	Family members and caregivers play a significant supporting role in the rehabilitation process after stroke , a role that may increase with the growing trend of providing stroke rehabilitation in the individual 's own home after discharge from the hospital .
OBJECTIVE	To explore the impact of family involvement in exercise delivery after stroke from the perspective of the individual with stroke and his or her family member .
METHODS	A qualitative research design was used in which in-depth semi-structured interviews were carried out with participants who had taken part in an 8-week family-mediated exercise program ( FAME ) .
METHODS	A phenomenological theoretical framework and a grounded theory methodology were used to inform the data analysis .
RESULTS	Fifteen individuals with acute stroke and 15 designated `` family '' members participated in the study after completion of an 8-week , individually tailored , family-mediated exercise intervention .
RESULTS	An overarching concept of patient-centeredness emerged after data analysis , which detailed the extent to which individuals with stroke and their families felt that their rehabilitation was enhanced by the active role of their families .
RESULTS	Four key themes that expanded the concept of patient-centeredness were identified : personalized nature of the reported benefits , therapeutic value of the program , family involvement , and caregiver commitment to program .
CONCLUSIONS	This research serves to increase our understanding of the role of family members in the rehabilitation process after stroke , particularly in relation to exercise delivery , from the perspective of the individuals with stroke and their family members .

###24660272
OBJECTIVE	Scaling and root planing ( SRP ) is the primary non-surgical treatment for periodontitis , but its effectiveness is limited .
OBJECTIVE	Consequently , various adjunctive therapies have been investigated to improve clinical outcome .
OBJECTIVE	This study evaluated the clinical effects of one SRP procedure alone or combined with local administration of hydrogen peroxide gel using customized trays for the treatment of subjects with chronic periodontitis over a period of six months .
METHODS	An examiner-blind clinical trial was conducted among 30 subjects with moderate to advanced periodontitis who were randomized to SRP alone or SRP combined with prescription custom-tray application ( Perio Tray ) of 1.7 % hydrogen peroxide gel ( Perio Gel ) for a period of three months , then extended to six months .
METHODS	Following impressions for the test group , all subjects brushed twice daily with a regular dentifrice and toothbrush for a four-week acclimation phase to standardize oral conditions ( while trays were fabricated ) prior to initiating the treatment phase .
METHODS	SRP was performed three weeks after baseline , and clinical assessments , i.e. , pocket probing depth ( PPD ) and bleeding index ( BI ) , were conducted at baseline and after two , five , 13 , and 26 weeks of peroxide gel applications .
METHODS	Clinical variables were compared by ANCOVA and paired t-tests after each treatment interval .
RESULTS	A total of 13 test and 15 control subjects completed the original three-month trial , of whom 10 test and 13 control subjects finished the three-month extension .
RESULTS	After two weeks of peroxide gel use prior to SRP , mean PPD for the test group significantly decreased from baseline by 0.21 mm and mean BI significantly dropped by 0.14 ; clinical parameters for the control group were unchanged .
RESULTS	Two weeks following SRP , mean PPD significantly decreased from baseline by 0.65 mm for the test group and 0.17 mm for the control ; mean BI significantly dropped by 0.17 for the test group and 0.05 for the control .
RESULTS	Ten weeks following SRP , mean PPD decreases were 0.77 mm for the test group and 0.13 mm for the control , and mean BI reductions were 0.14 for the test group and 0.00 for the control .
RESULTS	For subjects who completed the three-month extension ( i.e. , 23 weeks post-SRP ) , mean PPD decreases were 0.72 mm for the test group and 0.13 mm for the control , and mean BI reductions were 0.05 for the test group and 0.01 for the control .
RESULTS	Analysis of deeper pockets ( i.e. , > 5 mm at baseline ) showed the same relationship for PPD , but with larger differences between groups .
RESULTS	For example , after two weeks of peroxide gel use prior to SRP , mean PPD decreased by 0.48 mm for the test group compared to 0.04 mm for the control .
RESULTS	Two weeks after SRP , mean PPD decreased from baseline by 1.40 mm for the test group and 0.60 mm for the control , and 10 weeks after SRP by 1.57 mm for the test group and 0.58 mm for the control .
RESULTS	After the extension ( i.e. , 23 weeks post-SRP ) , mean PPD changed from baseline by 1.50 mm for the test group and 0.55 mm for the control .
RESULTS	With the exception of BI at 23 weeks post-SRP , all reductions cited above for the test group were statistically significantly different from the control group for both PPD and BI for all comparisons .
CONCLUSIONS	When compared with SRP alone , clinical improvements in PPD ( e.g. , -1.0 mm for pockets > 5 mm at baseline ) were maintained for up to six months after SRP with adjunctive use of 1.7 % hydrogen peroxide gel , locally administered using prescription customized trays in the treatment of subjects with moderate to advanced periodontitis .

###25751215
OBJECTIVE	To evaluate the association between low-dose aspirin initiated before conception and the risk of preterm birth .
METHODS	This was a secondary analysis of the Effects of Aspirin in Gestation and Reproduction trial .
METHODS	Women with a history of pregnancy loss ( original stratum : one loss less than 20 weeks of gestation during the previous year ; expanded stratum : one or two losses with no restrictions on timing or gestational age of the losses ) were randomized to either daily low-dose aspirin ( 81 mg , n = 615 ) and folic acid or folic acid alone ( placebo ; n = 613 ) .
METHODS	Preterm birth was compared between groups using intent-to-treat analysis .
RESULTS	Preterm birth rates were 4.1 % ( 22/535 low-dose aspirin ) and 5.7 % ( 31/543 placebo ) ( relative risk [ RR ] 0.72 , 95 % confidence interval [ CI ] 0.42-1 .23 ) ; spontaneous preterm birth rates were 1.1 % ( 6/535 low-dose aspirin ) and 2.2 % ( 12/543 placebo ) ( RR 0.51 , 95 % CI 0.19-1 .34 ) ; medically indicated preterm birth rates were 2.6 % ( 14/535 low-dose aspirin ) and 2.9 % ( 16/543 placebo ) ( RR 0.89 , 95 % CI 0.44-1 .80 ) .
RESULTS	After restriction to confirmed pregnancies using inverse probability weighting , preterm birth rates were 5.7 % and 9.0 % ( RR 0.63 , 95 % CI 0.37-1 .09 ) and spontaneous preterm birth rates were 1.4 % and 3.2 % ( RR 0.44 , 95 % CI 0.17-1 .18 ) .
RESULTS	In confirmed pregnancies in the original stratum , preterm birth occurred in 3.8 % and 9.7 % of the low-dose aspirin and placebo groups , respectively ( RR 0.39 , 95 % CI 0.16-0 .94 ) .
CONCLUSIONS	Preconception low-dose aspirin was not significantly associated with the overall rate of preterm birth .
CONCLUSIONS	Although the study was underpowered for this secondary analysis , numeric trends in favor of benefit , particularly in the women with a recent , single early pregnancy loss , warrant further investigation .
BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT00467363 .

###25092108
BACKGROUND	Cardiovascular disease is the leading cause of death worldwide .
BACKGROUND	Higher oxidative stress may contribute to the pathogenesis of coronary artery disease ( CAD ) .
BACKGROUND	The purpose of this study was to investigate the effect of L-carnitine ( LC , 1000mg/d ) on the markers of oxidative stress and antioxidant enzymes activities in CAD patients .
METHODS	We enrolled 47 CAD patients in the study .
METHODS	The CAD patients were identified by cardiac catheterization as having at least 50 % stenosis of one major coronary artery .
METHODS	The subjects were randomly assigned to the placebo ( n = 24 ) and LC ( n = 23 ) groups .
METHODS	The intervention was administered for 12weeks .
METHODS	The levels of serum LC , plasma malondialdehyde ( MDA ) , and erythrocyte antioxidant enzymes activities [ catalase ( CAT ) , superoxide dismutase ( SOD ) , glutathione peroxidase ( GPx ) ] were measured before and after intervention .
RESULTS	Thirty-nine subjects completed the study ( placebo , n = 19 ; LC , n = 20 ) .
RESULTS	After 12weeks of LC supplementation , the level of MDA was significantly reduced ( 2.00.3 to 1.80.3 mol/L , P = 0.02 ) and the level of LC ( 33.613.6 to 40.012.0 mol/L , P = 0.04 ) and antioxidant enzymes activities [ CAT ( 12.75.5 to 13.15.8 U/mg of protein , P = 0.02 ) , SOD ( 14.82.9 to 20.75.8 U/mg of protein , P < 0.01 ) , and GPx ( 20.33.4 to 23.03.1 U/mg of protein , P = 0.01 ) ] were significantly increased .
RESULTS	The level of LC was significantly positively correlated with the antioxidant enzymes activities ( CAT , = 0.87 , P = 0.02 ; SOD , = 0.72 , P < 0.01 ) .
CONCLUSIONS	LC supplementation at a dose of 1000mg/d was associated with a significant reduction in oxidative stress and an increase in antioxidant enzymes activities in CAD patients .
CONCLUSIONS	CAD patients might benefit from using LC supplements to increase their anti-oxidation capacity .
BACKGROUND	Clinical Trials.gov Identifier : NCT01819701 .

###25892145
BACKGROUND	Patients with recurrent or metastatic squamous-cell carcinoma of the head and neck ( HNSCC ) progressing after first-line platinum regimens have a poor prognosis and few treatment options .
BACKGROUND	Afatinib , an irreversible ERBB family blocker , has shown efficacy in a phase 2 study in this setting .
BACKGROUND	We aimed to assess the efficacy and safety of afatinib compared with methotrexate as second-line treatment in patients with recurrent or metastatic HNSCC progressing on or after platinum-based therapy .
METHODS	In this open-label , phase 3 , randomised controlled trial conducted in 101 centres in 19 countries , we enrolled patients aged 18 years or older with histologically or cytologically confirmed HNSCC that was recurrent , metastatic , or both who had progressed on or after first-line platinum-based therapy , were not amenable for salvage surgery or radiotherapy , and who had an Eastern Cooperative Oncology Group ( ECOG ) performance status of 0 or 1 .
METHODS	Previous treatment with more than one systemic regimen in this setting was not allowed ; previous treatment with EGFR-targeted antibody therapy ( but not EGFR-targeted tyrosine-kinase inhibitors ) was allowed .
METHODS	We randomly assigned eligible patients in a 2:1 ratio to receive oral afatinib ( 40 mg/day ) or intravenous methotrexate ( 40 mg/m ( 2 ) per week ) , stratified by ECOG performance status and previous EGFR-targeted antibody therapy for recurrent or metastatic disease .
METHODS	Randomisation was done centrally with an interactive voice or web-based response system .
METHODS	Clinicians and patients were not masked to treatment allocation ; independent review of tumour response was done in a blinded manner .
METHODS	The primary endpoint was progression-free survival as assessed by an independent , central imaging review committee .
METHODS	Efficacy analyses were done in the intention-to-treat population and safety analyses were done in patients who received at least one dose of study drug .
METHODS	This ongoing study is registered with ClinicalTrials.gov , number NCT01345682 .
RESULTS	Between Jan 10 , 2012 , and Dec 12 , 2013 , we enrolled 483 patients and randomly assigned 322 to afatinib and 161 to methotrexate .
RESULTS	After a median follow-up of 67 months ( IQR 31-90 ) , progression-free survival was longer in the afatinib group than in the methotrexate group ( median 26 months [ 95 % CI 20-27 ] for the afatinib group vs 17 months [ 15-24 ] for the methotrexate group ; hazard ratio [ HR ] 080 [ 95 % CI 065-098 ] , p = 0030 ) .
RESULTS	The most frequent grade 3 or 4 drug-related adverse events were rash or acne ( 31 [ 10 % ] of 320 patients in the afatinib group vs none of 160 patients in the methotrexate group ) , diarrhoea ( 30 [ 9 % ] vs three [ 2 % ] ) , stomatitis ( 20 [ 6 % ] vs 13 [ 8 % ] ) , fatigue ( 18 [ 6 % ] vs five [ 3 % ] ) , and neutropenia ( 1 [ < 1 % ] vs 11 [ 7 % ] ) ; serious adverse events occurred in 44 ( 14 % ) of afatinib-treated patients and 18 ( 11 % ) of methotrexate-treated patients .
CONCLUSIONS	Afatinib was associated with significant improvements in progression-free survival and had a manageable safety profile .
CONCLUSIONS	These findings provide important new insights into the treatment of this patient population and support further investigations with irreversible ERBB family blockers in HNSCC .
BACKGROUND	Boehringer Ingelheim .

###24220326
BACKGROUND	Infants are at the highest risk for meningococcal disease and a broadly protective and safe vaccine is an unmet need in this youngest population .
BACKGROUND	We evaluated the immunogenicity and safety of a 4-dose infant/toddler regimen of MenACWY-CRM given at 2 , 4 , 6 , and 12 months of age concomitantly with pentavalent diphtheria-tetanus-acellular pertussis-Hemophilus influenzae type b-inactivated poliovirus-combination vaccine ( DTaP-IPV/Hib ) , hepatitis B vaccine ( HBV ) , 7 - or 13-valent conjugate pneumococcal vaccine ( PCV ) , and measles , mumps , and rubella vaccine ( MMR ) .
RESULTS	Four doses of MenACWY-CRM induced hSBA titers 8 in 89 % , 95 % , 97 % , and 96 % of participants against serogroups A , C , W-135 , and Y , respectively .
RESULTS	hSBA titers 8 were present in 76-98 % of participants after the first 3 doses .
RESULTS	A categorical linear analysis incorporating vaccine group and study center showed responses to routine vaccines administered with MenACWY-CRM were non-inferior to routine vaccines alone , except for seroresponse to the pertussis antigen fimbriae .
RESULTS	The reactogenicity profile was not affected when MenACWY-CRM was administered concomitantly with routine vaccines .
CONCLUSIONS	MenACWY-CRM administered with routine concomitant vaccinations in young infants was well tolerated and induced highly immunogenic responses against each of the serogroups without significant interference with the immune responses to routine infant vaccinations .
METHODS	Healthy 2 month old infants were randomized to receive MenACWY-CRM with routine vaccines ( n = 258 ) or routine vaccines alone ( n = 271 ) .
METHODS	Immunogenicity was assessed by serum bactericidal assay using human complement ( hSBA ) .
METHODS	Medically attended adverse events ( AEs ) , serious AEs ( SAEs ) and AEs leading to study withdrawal were collected throughout the study period .

###24494283
OBJECTIVE	To compare the efficacy on acute pain treated under the different time of needle retention so as to provide the scientific evidence for the optimization of needle retention time for acupuncture analgesia .
METHODS	Eighty cases of acute pain ( acute lumbar sprain , stiffness of neck ) were randomized into 4 groups .
METHODS	Acupuncture was applied to all the patients .
METHODS	After the arrival of needling sensation , the needles were retained for 20 min , 30 min , 45 min and 60 min in different groups separately .
METHODS	For acute lumbar sprain , Ashi ( Extra ) , Houxi ( SI 3 ) and Weizhong ( BL 40 ) were the main points .
METHODS	For stiffness of neck , Ashi ( Extra ) , Fengchi ( GB 20 ) and Lieque ( LU 7 ) were the main points .
METHODS	McGill pain scale , the internationally recognized pain description and measurement was adopted to observe the indexes and record the score changes of each item of pain symptoms before and 3 months after treatment .
METHODS	The immediate analgesic efficacy under different time of needle retention and the longterm efficacy in follow-up visit 3 months after treatment were compared and assessed among the groups .
RESULTS	The scores of visual analogue scale ( VAS ) and present pain intensity ( PPI ) after treatment were all improved significantly as compared with those before treatment in the 4 groups ( all P < 0.01 ) , and the result in the 45 min group was superior to the other 3 groups ( VAS : 2.90 + / -0.87 vs 5.52 + / -1.01 , 4.45 + / -0.81 , 5.95 + / -1.07 ; PPI : 1.40 + / -0.21 vs 2.26 + / -0.54 , 2.21 + / -0.43 , 2.28 + / -0.74 , all P < 0.01 ) .
RESULTS	The total effective rate of the immediate analgesia was 95.0 % ( 19/20 ) in the 45 min group , which was better than that in each of the other 3 groups .
CONCLUSIONS	The 45 min of needle retention achieves the best efficacy of acupuncture analgesia in treatment of acute pain .

###24751369
OBJECTIVE	The aim of the study was to determine whether experimental manipulation of sense of control would change moderate drinkers ' ( N = 106 ) task-specific motivational structure and explicit and implicit determinants of their urge to drink alcohol .
METHODS	The effects of various levels of information-enhancement and goal-setting on participants ' performance on experimental tasks were assessed .
METHODS	Participants were randomly assigned to a high-sense-of-control , low-sense-of-control , or no-intervention group .
METHODS	Dependent measures were indices derived from a task-specific version of the Personal Concerns Inventory and the Shapiro Control Inventory , Alcohol Urge Questionnaire , and alcohol Stroop test .
RESULTS	At baseline , there were no differences among the groups on any of the measures ; however , post-experimentally , induced sense of control had led to increases in adaptive motivation and decreases in explicit and implicit measures of the urge to drink .
CONCLUSIONS	The results show that sense of control can be experimentally induced .
CONCLUSIONS	This finding has important clinical implications .

###25751199
OBJECTIVE	To estimate contraceptive efficacy , safety , acceptability , and fit of a single-size diaphragm used with contraceptive gel .
METHODS	We conducted a multicenter trial in which 450 couples used the single-size diaphragm , 300 randomized to acid-buffering gel and 150 to nonoxynol-9 , for at least 190 days and six menstrual cycles .
METHODS	Visits were at enrollment and after menstrual cycles 1 , 3 , and 6 .
METHODS	Study outcomes included pregnancy probability , safety , acceptability , and fit .
METHODS	Pregnancy and safety were compared with an historical control group who used a standard diaphragm with these gels .
RESULTS	Most ( 439/450 [ 98 % ] ) women could be fitted with the single-size diaphragm .
RESULTS	A total of 421 of 450 ( 94 % ) provided follow-up .
RESULTS	The 35 study pregnancies yielded 6-month Kaplan-Meier cumulative typical use pregnancy probabilities per 100 women with 95 % confidence intervals ( CIs ) of 10.4 ( 6.9-14 .0 ) for all users and 9.6 ( 5.5-13 .6 ) and 12.5 ( 5.4-19 .5 ) with acid-buffering gel and nonoxynol-9 , respectively .
RESULTS	Historical control analysis yielded a propensity score-adjusted estimate of this pregnancy probability for the single-size diaphragm of 11.3 compared with 10.7 per 100 women for the standard diaphragm ( [ rounded ] difference 0.7 , 95 % CI -3.6 to 4.9 ) .
RESULTS	Approximately half ( 51 % ) reported at least one urogenital event but compared favorably to the standard diaphragm in historical control analysis .
RESULTS	Most ( 282/342 [ 82 % ] ) liked the diaphragm .
RESULTS	Results suggest that if provided by a clinician , 94 % ( 95 % CI 92-96 % ) could insert , correctly position , and remove the diaphragm .
CONCLUSIONS	The single-size diaphragm was safe , as effective as a standard diaphragm , and acceptable when used with contraceptive gel .
BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT00578877 .

###24691680
OBJECTIVE	The present study investigated the effectiveness of a newly developed 3-week self-compassion group intervention for enhancing resilience and well-being among female college students .
METHODS	Fifty-two students were randomly assigned to either an intervention designed to teach skills of self-compassion ( n = 27 ) or an active control group intervention in which general time management skills were taught ( n = 25 ) .
METHODS	Both interventions comprised 3 group meetings held over 3 weeks .
METHODS	To measure resilience and well-being gains , participants filled out a number of questionnaires before and after the intervention .
RESULTS	Results showed that the self-compassion intervention led to significantly greater increases in self-compassion , mindfulness , optimism , and self-efficacy , as well as significantly greater decreases in rumination in comparison to the active control intervention .
RESULTS	Whereas both interventions increased life satisfaction and connectedness , no differences were found for worry and mood .
CONCLUSIONS	These findings suggest that a brief self-compassion intervention has potential for improving student resilience and well-being .

###25790209
BACKGROUND	Gram-negative organisms are a major health care concern with increasing prevalence of infection and community spread .
BACKGROUND	Our primary aim was to characterize the transmission dynamics of frequently encountered gram-negative bacteria in the anesthesia work area environment ( AWE ) .
BACKGROUND	Our secondary aim was to examine links between these transmission events and 30-day postoperative health care-associated infections ( HCAIs ) .
METHODS	Gram-negative isolates obtained from the AWE ( patient nasopharynx and axilla , anesthesia provider hands , and the adjustable pressure-limiting valve and agent dial of the anesthesia machine ) at 3 major academic medical centers were identified as possible intraoperative bacterial transmission events by class of pathogen , temporal association , and phenotypic analysis ( analytical profile indexing ) .
METHODS	The top 5 frequently encountered genera were subjected to antibiotic disk diffusion sensitivity to identify epidemiologically related transmission events .
METHODS	Complete multivariable logistic regression analysis and binomial tests of proportion were then used to examine the relative contributions of reservoirs of origin and within - and between-case modes of transmission , respectively , to epidemiologically related transmission events .
METHODS	Analyses were conducted with and without the inclusion of duplicate transmission events of the same genera occurring in a given study unit ( first and second case of the day in each operating room observed ) to examine the potential effect of statistical dependency .
METHODS	Transmitted isolates were compared by pulsed-field gel electrophoresis to disease-causing bacteria for 30-day postoperative HCAIs .
RESULTS	The top 5 frequently encountered gram-negative genera included Acinetobacter , Pseudomonas , Brevundimonas , Enterobacter , and Moraxella that together accounted for 81 % ( 767/945 ) of possible transmission events .
RESULTS	For all isolates , 22 % ( 167/767 ) of possible transmission events were identified by antibiotic susceptibility patterns as epidemiologically related and underwent further study of transmission dynamics .
RESULTS	There were 20 duplicates involving within - and between-case transmission events .
RESULTS	Thus , approximately 19 % ( 147/767 ) of isolates excluding duplicates were considered epidemiologically related .
RESULTS	Contaminated provider hand reservoirs were less likely ( all isolates , odds ratio 0.12 , 95 % confidence interval 0.03-0 .50 , P = 0.004 ; without duplicate events , odds ratio 0.05 , 95 % confidence interval 0.01-0 .49 , P = 0.010 ) than contaminated patient or environmental sites to serve as the reservoir of origin for epidemiologically related transmission events .
RESULTS	Within - and between-case modes of gram-negative bacilli transmission occurred at similar rates ( all isolates , 7 % between-case , 5.2 % within-case , binomial P value 0.176 ; without duplicates , 6.3 % between-case , 3.7 % within-case , binomial P value 0.036 ) .
RESULTS	Overall , 4.0 % ( 23/548 ) of patients suffered from HCAIs and had an intraoperative exposure to gram-negative isolates .
RESULTS	In 8.0 % ( 2/23 ) of those patients , gram-negative bacteria were linked by pulsed-field gel electrophoresis to the causative organism of infection .
RESULTS	Patient and provider hands were identified as the reservoirs of origin and the environment confirmed as a vehicle for between-case transmission events linked to HCAIs .
CONCLUSIONS	Between - and within-case AWE gram-negative bacterial transmission occurs frequently and is linked by pulsed-field gel electrophoresis to 30-day postoperative infections .
CONCLUSIONS	Provider hands are less likely than contaminated environmental or patient skin surfaces to serve as the reservoir of origin for transmission events .

###24965190
OBJECTIVE	Health-related quality of life ( HRQOL ) is an important indicator of well-being in patients with epilepsy .
OBJECTIVE	When assessing changes in HRQOL over time , some of the changes observed may be due to the patients ' change in the internal standards , value , or meaning that they attribute to the HRQOL domain being measured , rather than actual change , a phenomenon known as response shift .
OBJECTIVE	Response shifts are increasingly recognized as an important explanation for the seemingly paradoxical or counterintuitive HRQOL results often observed in chronic conditions .
OBJECTIVE	We investigated the presence of changing values ( reprioritization response shift ) in data from a surgical randomized controlled trial of patients with temporal lobe epilepsy ( TLE ) .
METHODS	Eighty patients with TLE , who were randomized to surgical and medical treatment , provided data on the epilepsy-specific 31-item Quality of life in Epilepsy ( QOLIE-31 ) questionnaire at baseline and 1 year after randomization .
METHODS	Reprioritization response shift among the seven QOLIE-31 domains was assessed using changes in the relative importance weights derived from logistic regression and discriminant analysis .
RESULTS	The relative importance analysis showed a statistically significant increase over time in the importance of social function , but a significant decrease in the relative importance of seizure worry .
RESULTS	There were no significant changes in the relative importance of the remaining five domains in distinguishing between surgical and medical group over time .
CONCLUSIONS	Patients that receive surgical treatment are more likely to experience a decrease in the valuation of seizure worry and an increase in the value of social function as compared to patients who are medically treated .
CONCLUSIONS	Changes in expectation about seizure freedom and social function may confound the assessment of longitudinal change on these outcomes , and highlight the importance of assessing response shift and the limitations of assessing HRQOL at a single point in time or without a control group .
CONCLUSIONS	A PowerPoint slide summarizing this article is available for download in the Supporting Information section here .

###25599428
BACKGROUND	Longevity results in changes to patterns of health , with an increased prevalence of chronic diseases .
BACKGROUND	Parkinson 's disease ( PD ) is described as a progressive neurodegenerative disease related to age that influences quality of life ( QoL ) and leads to depression .
OBJECTIVE	The study intended to assess changes in QoL and depression in older adults with PD through use of Feldenkrais method-based exercise .
METHODS	The study was a controlled , blinded , and randomized clinical trial .
METHODS	The study occurred at the University Hospital of the Federal University of Sergipe in Aracaju , Sergipe , Brazil .
METHODS	Participants were 30 patients , aged between 50 and 70 y , with idiopathic PD , who signed an informed consent form and were randomly assigned to 2 groups : treatment and control .
METHODS	The treatment group underwent 50 sessions of an exercise program based on the Feldenkrais method .
METHODS	The control group received educational lectures during this period .
METHODS	The treatment group 's 50 sessions , given 2 / wk on alternate days and lasting 60 min , were conducted in an appropriate room at the hospital .
METHODS	Two surveys , the Parkinson 's Disease Quality of Life ( PDQL ) questionnaire and the Beck Depression Inventory ( BDI ) , were administered before and after the sessions for both groups .
RESULTS	After the exercises based on the Feldenkrais method , the treated group showed improvement in QoL scores ( P = .004 ) as well as a reduction in the level of depression ( P = .05 ) compared with the control group .
CONCLUSIONS	The findings in the current study indicate that it is likely that the practice of a program based on the Feldenkrais method can contribute greatly to the QoL of patients with PD , suggesting the importance of interventions that promote wellness for this population .

###25586331
BACKGROUND	Fibrocaps , a ready-to-use , dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen , is being developed as an adjunct for surgical hemostasis .
METHODS	Safety and efficacy of Fibrocaps applied directly or by spray device , in combination with gelatin sponge , was compared with that of gelatin sponge-alone in two randomized , single-blind controlled trials : FC-002 US ( United States ) and FC-002 NL ( the Netherlands ) .
METHODS	A total of 126 adult patients were randomized ( Fibrocaps : n = 47 [ FC-002 US ] , n = 39 [ FC-002 NL ] ; gelatin sponge alone : n = 23 [ FC-002 US ] , n = 17 [ FC-002 NL ) .
METHODS	One bleeding site was treated during a surgical procedure ( n = 125 ) .
METHODS	Time to hemostasis ( primary end point ) was measured , with a 28-d safety follow-up .
METHODS	Four surgical indications included hepatic resection ( n = 58 ) , spinal procedures ( n = 37 ) , peripheral vascular procedures ( n = 30 ) , and soft tissue dissection ( n = 1 ) .
RESULTS	Mean ( standard deviation ) time to hemostasis was significantly shorter after Fibrocaps treatment than after gelatin sponge alone ( FC-002 US : 1.9 [ 1.3 ] versus 4.8 min [ 3.1 ] , P < 0.001 ; FC-002 NL : 2.2 [ 1.3 ] versus 4.4 min [ 3.1 ] , P = 0.004 ) .
RESULTS	The incidence of hemostasis was greater after Fibrocaps compared with that of gelatin sponge alone within 3min ( FC-002 US : 83 % versus 35 % , P < 0.001 ; FC-002 NL : 77 % versus 53 % , P = 0.11 ) , 5min ( 94 % versus 61 % , P = 0.001 ; 95 % versus 71 % , P = 0.022 ) , and 10min ( 100 % versus 78 % , P = 0.003 ; 100 % versus 82 % , P = 0.025 ) .
RESULTS	Adverse events were consistent with surgical procedures performed and patients ' underlying diseases and generally similar between treatment arms ; most were mild or moderate in severity .
RESULTS	Non-neutralizing antithrombin antibodies were detected in 5 % of Fibrocaps-treated patients on day29 .
CONCLUSIONS	Fibrocaps had good safety and efficacy profiles , supporting continuing clinical development as a novel fibrin sealant .

###25411291
BACKGROUND	Refraining from breastfeeding to prevent HIV transmission has been associated with increased morbidity and mortality in HIV-exposed African infants .
OBJECTIVE	The objective was to assess risks of common and serious infectious morbidity by feeding mode in HIV-exposed , uninfected infants 6 mo of age with special attention to the issue of reverse causality .
METHODS	HIV-infected pregnant women from 5 sites in Burkina Faso , Kenya , and South Africa were enrolled in the prevention of mother-to-child transmission Kesho Bora trial and counseled to either breastfeed exclusively and cease by 6 mo postpartum or formula feed exclusively .
METHODS	Maternal-reported morbidity ( fever , diarrhea , and vomiting ) and serious infectious events ( SIEs ) ( gastroenteritis and lower respiratory tract infections ) were investigated for 751 infants for 2 age periods ( 0-2 .9 and 3-6 mo ) by using generalized linear mixed models with breastfeeding as a time-dependent variable and adjustment for study site , maternal education , economic level , and cotrimoxazole prophylaxis .
RESULTS	Reported morbidity was not significantly higher in nonbreastfed compared with breastfed infants [ OR : 1.31 ( 95 % CI : 0.97 , 1.75 ) and 1.21 ( 0.90 , 1.62 ) at 0-2 .9 and 3-6 mo of age , respectively ] .
RESULTS	Between 0 and 2.9 mo of age , never-breastfed infants had increased risks of morbidity compared with those of infants who were exclusively breastfed ( OR : 1.49 ; 95 % CI : 1.01 , 2.2 ; P = 0.042 ) .
RESULTS	The adjusted excess risk of SIEs in nonbreastfed infants was large between 0 and 2.9 mo ( OR : 6.0 ; 95 % CI : 2.2 , 16.4 ; P = 0.001 ) .
RESULTS	Between 3 and 6 mo , the OR for SIEs was sensitive to the timing of breastfeeding status , i.e. , 4.3 ( 95 % CI : 1.2 , 15.3 ; P = 0.02 ) when defined at end of monthly intervals and 2.0 ( 95 % CI : 0.8 , 5.0 ; P = 0.13 ) when defined at the beginning of intervals .
RESULTS	Of 52 SIEs , 3 mothers reported changes in feeding mode during the SIE although none of the mothers ceased breastfeeding completely .
CONCLUSIONS	Not breastfeeding was associated with increased risk of serious infections especially between 0 and 2.9 mo of age .
CONCLUSIONS	The randomized controlled trial component of the Kesho Bora study was registered at Current Controlled Trials ( www.controlled-trials.com ) as ISRCTN71468401 .

###25029834
OBJECTIVE	To study the synergistic effects of electroacupuncture on the treatment of knee osteoarthritis after arthroscopic debridement .
METHODS	From May 2008 to July 2010 , 78 patients with knee osteoarthritis were randomly divided into two groups .
METHODS	There were 42 patients in the experimental group , including 16 males and 26 females , ranging in age from 41 to 63 years , with an average of ( 53.62 + / - 6.53 ) years ; the disease course ranged from 8 to 24 months , with an average of ( 10.35 + / - 6.42 ) months .
METHODS	The patients were treated with arthroscopic debridement combined with electroacupuncture after operation .
METHODS	There were 36 patients in the control group , including 14 males and 22 females , ranging in age from 40 to 62 years , with an average of ( 54.34 + / - 7.67 ) years ; the disease course ranged from 6 to 25 months , with an average of ( 11.94 + / - 5.13 ) months .
METHODS	Those patients were treated only with arthroscopic debridment .
METHODS	All the patients performed isometric quadriceps femoris contraction exercise and knee flexion and extension activities after operation .
METHODS	The visual analog scale ( VAS ) score and Lysholm knee score were used to evaluate the therapeutic effects .
RESULTS	All the patients were followed up , and the duration ranged from 12 to 30 months , with an average of 15.6 months .
RESULTS	At the final follow-up , VAS score was significantly decreased , and the Lysholm score , except for the item demanding for support , significantly increased , compared with those before surgery respectively in both groups .
RESULTS	There was significant difference in VAS score between two groups after treatment .
RESULTS	As to Lysholm score , there were significant differences in limp , pain , swelling , stair activity and squat , but there were no significant differences in items of interlocking and instability between two groups after treatment .
CONCLUSIONS	Electroacupuncture can effectively improve the clinical symptoms and knee joint 's motor function of knee joints in patients with knee osteoarthritis , as well as the synergistic effects on the treatment of knee osteoarthritis after arthroscopic debridement , leading to a much better long-term therapeutic effect with respect of improving the function of knee joint .
CONCLUSIONS	This therapy , combined with traditional Chinese medicine and Western Medicine , is worth of clinical application in the treatment of knee osteoarthritis .

###25467586
BACKGROUND	Preclinical studies suggest that P2X3 receptors are expressed by airway vagal afferent nerves and contribute to the hypersensitisation of sensory neurons .
BACKGROUND	P2X3 receptors could mediate sensitisation of the cough reflex , leading to chronic cough .
BACKGROUND	We aimed to investigate the efficacy of a first-in-class oral P2X3 antagonist , AF-219 , to reduce cough frequency in patients with refractory chronic cough .
METHODS	We did a double-blind , placebo-controlled , two-period , crossover study at one UK centre .
METHODS	With a computer-generated sequence , we randomly assigned patients with refractory chronic cough to AF-219 , 600 mg twice a day , or to placebo ( 1:1 ) , and then , after a 2 week washout , assigned patients to receive the other treatment .
METHODS	Patients , health-care providers , and investigators were masked to sequence assignment .
METHODS	We assessed daytime cough frequency ( primary endpoint ) at baseline and after 2 weeks of treatment using 24 h ambulatory cough recordings .
METHODS	The primary analysis used a mixed effects model with the intention-to-treat population .
METHODS	This study was registered at ClinicalTrials.gov , number NCT01432730 .
RESULTS	Of 34 individuals assessed between Sept 22 , 2011 , and Nov 29 , 2012 , we randomly assigned 24 patients ( mean age 545 years ; SD 111 ) .
RESULTS	In the observed case analysis , cough frequency was reduced by 75 % when patients were allocated to AF-219 compared when allocated to placebo ( p = 00003 ) .
RESULTS	Daytime cough frequency fell from a mean 37 coughs per h ( SD 32 ) to 11 ( 8 ) coughs per h after AF-219 treatment versus 65 ( 163 ) coughs per h to 44 ( 51 ) coughs per h after placebo .
RESULTS	Six patients withdrew before the end of the study because of taste disturbances , which were reported by all patients taking AF-219 .
CONCLUSIONS	P2X3 receptors seem to have a key role in mediation of cough neuronal hypersensitivity .
CONCLUSIONS	Antagonists of P2X3 receptors such as AF-219 are a promising new group of antitussives .
BACKGROUND	Afferent Pharmaceuticals .

###25348259
BACKGROUND	Children with borderline to mild intellectual disability ( BMID ) have been shown to be at increased risk for psychosocial problems .
BACKGROUND	The presence of these psychosocial problems leads to parenting stress .
BACKGROUND	Stepping Stones Triple P ( SSTP ) is a parenting support program to support parents with children with BMID and psychosocial problems .
BACKGROUND	The aim of this study was to evaluate the effectiveness of SSTP compared to Care as Usual ( CAU ) in reducing psychosocial problems in children with BMID .
METHODS	We conducted a randomized controlled trial in the Northern provinces of the Netherlands .
METHODS	Parents of children aged 5 to 12 with borderline ( IQ 70 to 85 ) or mild ( IQ 70 to 50 ) ID and psychosocial problems were invited .
METHODS	Psychosocial problems were identified using the Strengths and Difficulties Questionnaire ( SDQ ) parent report ( 14 ) .
METHODS	Measurements were assessed before the intervention ( T0 ) , immediately after the intervention ( T1 ) and after a follow-up of six months ( T2 ) .
METHODS	SSTP takes 8 to 10 individual sessions of 40-90 minutes , provided over 10 to 12weeks .
METHODS	CAU concerned any service , except SSTP .
METHODS	Primary outcomes were the child 's psychosocial problems ( SDQ parent and teacher forms and the Eyberg Child Behavior Inventory , ECBI ) .
METHODS	Secondary outcomes were parenting stress ( Parenting Stress Index , PSI ) and parenting skills ( Alabama Parenting Questionnaire , APQ ) .
RESULTS	In total 209 parents of children aged 5 to 12 with BMID were allocated blindly to either SSTP ( n = 111 ) or CAU ( n = 98 ) .
RESULTS	In the intention to treat analyses , SSTP achieved no significantly better effect than CAU for the SDQ parent report , the ECBI and the APQ on the short - and long - term .
RESULTS	In the short term , SSTP was significantly more effective than CAU for the SDQ teacher report ( B = -2.25 , 95 % CI -3.79 to -0.71 ) and the PSI ( B = -7.06 , 95 % CI -12.11 to -2.01 ) .
RESULTS	For both SDQ teacher report and PSI , there was no statistically significant effect in the long term .
RESULTS	Dropout from SSTP was considerable ( 49 % ) , with the effects being solely found in the adherent SSTP subgroup .
CONCLUSIONS	SSTP had some short-term advantages over CAU , but not in the longer term .
BACKGROUND	Dutch Trial Register NTR2624 .
BACKGROUND	Registered 26 November 2010 .

###24884602
BACKGROUND	We aimed to assess the safety and tolerability of different doses of canakinumab versus placebo in patients with type 2 diabetes mellitus ( T2DM ) .
METHODS	Data were pooled from three studies in 1026 T2DM patients with different routes of administration , treatment regimens and follow-up duration .
METHODS	Canakinumab groups were categorised as low ( 0.03 mg/kg i.v. once ; N = 20 ) , intermediate ( 0.1 and 0.3 mg/kg i.v. once , 5 and 15 mg s.c. monthly ; N = 247 ) , medium ( 1.5 mg/kg i.v. once , 50 mg s.c. monthly and 150 mg s.c. once ; N = 268 ) , and high doses ( 10 mg/kg i.v. once and 150 mg s.c. monthly ; N = 137 ) and compared with placebo ( N = 354 ) .
METHODS	Incidences of adverse events ( AEs ) , serious AEs ( SAEs ) , discontinuations due to AEs , deaths , AEs of special interest related to interleukin-1 inhibition and T2DM disease , and laboratory abnormalities related to haematology and biochemistry parameters were reported .
METHODS	Safety was also analysed by age ( < 65 , 65 ) and gender .
RESULTS	Average exposure across all groups was6 months ( maximum ~ 17 months ) .
RESULTS	No dose response in AEs was observed but a trend towards more patients having at least one AE across canakinumab groups relative to placebo ( P = 0.0152 ) was observed .
RESULTS	SAEs were few and the incidence rate for most canakinumab groups was lower than that of placebo group except for the high-dose group ( 0.94 % versus 0.58 % per month in placebo ) .
RESULTS	A total of five patients discontinued treatment due to AEs across treatment groups .
RESULTS	No death was reported in any of the three studies .
RESULTS	A small , non-significant increase in the incidence rate of infection AEs was observed on canakinumab groups relative to placebo .
RESULTS	Canakinumab was associated with mostly mild decreases in WBC , neutrophils and platelet counts .
RESULTS	Additionally , mild increases in SGPT , SGOT and bilirubin were reported .
RESULTS	Overall , despite small differences , no clinically relevant findings were observed with respect to laboratory values and vital signs .
CONCLUSIONS	This pooled analysis demonstrated that canakinumab was safe and well tolerated over a treatment period up to 1.4 years at the four pooled doses evaluated , in agreement with safety findings reported in the individual studies .

###25091666
OBJECTIVE	This study was undertaken to compare the immunogenicity of a three dose and five dose schedule of an oral live-attenuated human rotavirus vaccine , Rotarix in south Indian infants .
METHODS	Healthy infants ( N = 90 ) , six to seven weeks of age were enrolled to receive three doses ( n = 45 ) or five doses of Rotarix vaccine ( n = 45 ) along with other scheduled vaccines , each dose separated by a four week interval .
METHODS	Blood samples were taken before vaccination and one month post-dose three in the Rotarix three dose group and one month post-dose five in the Rotarix five dose group ; all were tested for anti-rotavirus IgA by an antibody sandwich enzyme immunoassay .
RESULTS	At baseline , > 50 % of infants had > 20 units of anti-rotavirus IgA .
RESULTS	The seroconversion rates after three and five doses were low and not significantly different in the two groups .
RESULTS	However , among vaccine responders , children seropositive at baseline showed a much greater absolute increase in IgA antibody levels than children seronegative at baseline .
CONCLUSIONS	Rotarix vaccine showed low immunogenicity in south Indian children and increasing the number of doses did not increase the proportion of infants seroconverting after vaccination .

###25336165
OBJECTIVE	To determine whether outcomes for patients with cellulitis treated with oral antimicrobials are as good as for those who are treated with parenteral antimicrobials .
METHODS	A prospective randomized non-inferiority trial was conducted at a tertiary teaching hospital in Melbourne , Australia .
METHODS	Participants were patients referred by the emergency department for treatment of uncomplicated cellulitis with parenteral antimicrobials .
METHODS	Patients were randomized to receive either oral cefalexin or parenteral cefazolin .
METHODS	Parenteral antimicrobials were changed to oral after the area of cellulitis ceased progressing .
METHODS	The primary outcome was days until no advancement of the area of cellulitis .
METHODS	A non-inferiority margin of 15 % was set for the oral arm compared with the parenteral arm .
METHODS	Secondary outcomes were failure of treatment , pain , complications and satisfaction with care .
METHODS	This trial is registered with the Australian New Zealand Clinical Trials Registry ( ACTRN12611000685910 ) .
RESULTS	Twenty-four patients were randomized to oral antimicrobials and 23 to parenteral antimicrobials .
RESULTS	Mean days to no advancement of cellulitis was 1.29 ( SD 0.62 ) for the oral arm and 1.78 ( SD 1.13 ) for the parenteral arm , with a mean difference of -0.49 ( 95 % CI : -1.02 to +0.04 ) .
RESULTS	The upper limit of the 95 % CI of the difference in means of +0.04 was below the 15 % non-inferiority margin of +0.27 days , indicating non-inferiority .
RESULTS	More patients failed treatment in the parenteral arm ( 5 of 23 , 22 % ) compared with the oral arm ( 1 of 24 , 4 % ) , although this difference was not statistically significant ( P = 0.10 ) .
RESULTS	Pain , complications and satisfaction with care were similar for both groups .
CONCLUSIONS	Oral antimicrobials are as effective as parenteral antimicrobials for the treatment of uncomplicated cellulitis .

###24576271
BACKGROUND	This study aimed to examine the effects of a multidisciplinary treatment program on health-related quality of life of Iranian patients living with chronic low back , at 12months follow-up .
METHODS	This study is an extended follow-up of an original randomized , controlled trial with registration number NCT00600197 .
METHODS	In the present study 87 patients in an intervention group and 91 patients in a control group were assessed at 12months follow-up .
METHODS	The intervention was a group-based multidisciplinary rehabilitation program which continued by monthly motivational consultation by telephone from 6 to 12months after intervention .
METHODS	Data from three standard measures , Short Form 36 ( SF-36 ) , QDS and RDQ were collected at 3 , 6 and 12months follow-up and analyzed through repeated measures analysis of variance .
RESULTS	Despite the similarity between the two groups who completed the 6month follow-up in terms of all baseline variables , there were significant differences between the two groups in all domains of the SF-36 scale , as well as QDS and RDQ scales ( P < 0.05 ) .
RESULTS	Also , there were differences within each group over time in the SF-36 domains and disability measurements ( P < 0.05 ) .
RESULTS	The physical function mean score differed significantly when the interaction between groups and time points was examined ( P = 0.02 ) .
CONCLUSIONS	This study indicates that the multidisciplinary program could improve the domains of health related quality of life and disability in chronic low back pain patients up to 12months .

###25236346
BACKGROUND	The optimal duration of dual antiplatelet therapy ( DAPT ) following second-generation drug-eluting stent ( DES ) implantation is still debated .
OBJECTIVE	The aim of this study was to test the noninferiority of 6 versus 12 months of DAPT in patients undergoing percutaneous coronary intervention with second-generation DES .
METHODS	The SECURITY ( Second Generation Drug-Eluting Stent Implantation Followed by Six - Versus Twelve-Month Dual Antiplatelet Therapy ) trial was a 1:1 randomized , multicenter , international , investigator-driven , noninferiority study conducted from July 2009 to June 2014 .
METHODS	Patients with a stable or unstable angina diagnosis or documented silent ischemia undergoing revascularization with at least 1 second-generation DES were eligible .
METHODS	The primary endpoint was a composite of cardiac death , myocardial infarction ( MI ) , stroke , definite or probable stent thrombosis , or Bleeding Academic Research Consortium ( BARC ) type 3 or 5 bleeding at 12 months .
METHODS	The main secondary endpoint was a composite of cardiac death , MI , stroke , definite or probable stent thrombosis , or BARC type 2 , 3 , or 5 bleeding at 12 and 24 months .
RESULTS	Overall , 1,399 patients were enrolled in the study and randomized to receive 6 months ( n = 682 ) versus 12months ( n = 717 ) DAPT .
RESULTS	The primary composite endpoint occurred , respectively , in 4.5 % versus 3.7 % ( risk difference 0.8 % ; 95 % confidence interval [ CI ] : -2.4 % to 1.7 % ; p = 0.469 ) at 12 months .
RESULTS	The upper 95 % CI limit was lower than the pre-set margin of 2 % , confirming the noninferiority hypothesis ( p < 0.05 ) .
RESULTS	Moreover , no differences were observed in the occurrence of the secondary endpoint at 12 months ( 5.3 % vs. 4.0 % , difference : 1.2 % ; 95 % CI : -1.0 to 3.4 ; p = 0.273 ) and between 12 and 24 months ( 1.5 % vs. 2.2 % , difference : -0.7 % ; 95 % CI : -2.1 to 0.6 ; p = 0.289 ) .
RESULTS	Finally , no differences were observed in definite or probable stent thrombosis at 12 months ( 0.3 % vs. 0.4 % ; difference : -0.1 % ; 95 % CI : -0.7 to 0.4 ; p = 0.694 ) and between 12 and 24 months of follow-up ( 0.1 % vs. 0 % ; difference : 0.1 % ; 95 % CI : -0.1 to 0.4 ; p = 0.305 ) .
CONCLUSIONS	In a low-risk population , the noninferiority hypothesis of 6 vs. 12 months DAPT following second-generation DES implantation appears accepted for the incidence of cardiac death , MI , stroke , definite/probable stentthrombosis , and BARC type 3 or 5 bleeding at 12 months .
CONCLUSIONS	( Second Generation Drug-Eluting Stent Implantation Followed by Six - Versus Twelve-Month Dual Antiplatelet Therapy ; NCT00944333 ) .

###25298578
OBJECTIVE	Lafutidine is a new H2-blocker in India claimed to be more potent and effective than existing H2-blockers .
OBJECTIVE	Proton pump inhibitors ( PPIs ) , by virtue of their mechanism of action , have greater efficacy than H2-blockers in gastric acid suppression .
OBJECTIVE	However , clinical trials comparing H2-blockers directly with PPIs are limited .
OBJECTIVE	We carried out a head-to-head comparison of the effectiveness of lafutidine versus the PPI pantoprazole in uninvestigated dyspepsia [ CTRI/2013/12 / 004261 ] .
METHODS	A prospective , open label , randomized , controlled trial was conducted in a tertiary care hospital .
METHODS	Ambulatory adult patients with dyspepsia , not yet subjected to endoscopy , were recruited if they had at least moderately severe symptoms , defined as a score of 4 on a 7-point Global Overall Symptom ( GOS ) Scale .
METHODS	Those with alarm features or significant comorbidity were excluded .
METHODS	Subjects received either once daily lafutidine 10 mg or pantoprazole 40 mg , orally , for 8 weeks .
METHODS	Reflux , dysmotility and pain scores were assessed by Modified Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease ( mFSSGERD ) , and quality of life ( QoL ) by SF-8 scale .
METHODS	The latter had physical and mental components summarized by physical component summary score ( PCS ) and a mental component summary score ( MCS ) .
RESULTS	Of 122 patients enrolled , data of 57 on lafutidine and 60 on pantoprazole were analyzed .
RESULTS	At 4 weeks , proportion of subjects responding ( GOS score 2 ) in the two arms ( lafutidine 45.61 % vs. pantoprazole 48.33 % , P = 0.854 ) or showing symptom resolution ( GOS score 1 ) ( lafutidine 12.28 % vs. pantoprazole 5.00 % ; P = 0.197 ) were comparable .
RESULTS	Similarly at 8 weeks , both responder ( lafutidine 52.63 % vs. pantoprazole 56.67 % ; P = 0.712 ) and symptom resolution proportions ( lafutidine 33.33 % vs. pantoprazole 30 % ; P = 0.843 ) were comparable .
RESULTS	Total score on mFSSGERD scale , as well as all its three component scores , and PCS and MCS scores on QoL SF-8 scale showed improvement but no statistically significant difference between the two arms .
RESULTS	Tolerability of both drugs was excellent .
CONCLUSIONS	Lafutidine is well-tolerated and there is no clinically worthwhile difference between the two drugs in the empirical treatment of uninvestigated dyspepsia .

###25131977
BACKGROUND	An increasing number of patients with heart failure receive implantable cardioverter-defibrillators ( ICDs ) or cardiac resynchronisation defibrillators ( CRT-Ds ) with telemonitoring function .
BACKGROUND	Early detection of worsening heart failure , or upstream factors predisposing to worsening heart failure , by implant-based telemonitoring might enable pre-emptive intervention and improve outcomes , but the evidence is weak .
BACKGROUND	We investigated this possibility in IN-TIME , a clinical trial .
METHODS	We did this randomised , controlled trial at 36 tertiary clinical centres and hospitals in Australia , Europe , and Israel .
METHODS	We enrolled patients with chronic heart failure , NYHA class II-III symptoms , ejection fraction of no more than 35 % , optimal drug treatment , no permanent atrial fibrillation , and a recent dual-chamber ICD or CRT-D implantation .
METHODS	After a 1 month run-in phase , patients were randomly assigned ( 1:1 ) to either automatic , daily , implant-based , multiparameter telemonitoring in addition to standard care or standard care without telemonitoring .
METHODS	Investigators were not masked to treatment allocation .
METHODS	Patients were masked to allocation unless they were contacted because of telemonitoring findings .
METHODS	Follow-up was 1 year .
METHODS	The primary outcome measure was a composite clinical score combining all-cause death , overnight hospital admission for heart failure , change in NYHA class , and change in patient global self-assessment , for the intention-to-treat population .
METHODS	The trial is registered with ClinicalTrials.gov , number NCT00538356 .
RESULTS	We enrolled 716 patients , of whom 664 were randomly assigned ( 333 to telemonitoring , 331 to control ) .
RESULTS	Mean age was 655 years and mean ejection fraction was 26 % .
RESULTS	285 ( 43 % ) of patients had NYHA functional class II and 378 ( 57 % ) had NYHA class III .
RESULTS	Most patients received CRT-Ds ( 390 ; 587 % ) .
RESULTS	At 1 year , 63 ( 189 % ) of 333 patients in the telemonitoring group versus 90 ( 272 % ) of 331 in the control group ( p = 0013 ) had worsened composite score ( odds ratio 063 , 95 % CI 043-090 ) .
RESULTS	Ten versus 27 patients died during follow-up .
CONCLUSIONS	Automatic , daily , implant-based , multiparameter telemonitoring can significantly improve clinical outcomes for patients with heart failure .
CONCLUSIONS	Such telemonitoring is feasible and should be used in clinical practice .
BACKGROUND	Biotronik SE & Co. .
BACKGROUND	KG .

###24490063
OBJECTIVE	The aim of this prospective randomized trial was to compare operative factors , postoperative outcomes , and surgical complications of neck dissection ( ND ) when using the harmonic scalpel ( HS ) versus conventional haemostasis ( CH ) ( classic technique of tying and knots , resorbable ligature , and bipolar diathermy ) .
METHODS	Sixty-one patients who underwent ND with primary head and neck cancer ( HNSCC ) resection were enrolled in this study and were randomized into two homogeneous groups : CH ( conventional haemostasis with classic technique of tying and knots , resorbable ligature , and bipolar diathermy ) and HS ( haemostasis with harmonic scalpel ) .
METHODS	Outcomes of the study included operative time , intraoperative blood loss , drainage volume , postoperative pain , hospital stay , and incidence of intraoperative and postoperative complications .
RESULTS	The use of the HS reduced significantly the operating time , the intraoperative blood loss , the postoperative pain , and the volume of drainage .
RESULTS	No significant difference was observed in mean hospital stay and perioperative , and postoperative complications .
CONCLUSIONS	The HS is a reliable and safe tool for reducing intraoperative blood loss , operative time , volume of drainage and postoperative pain in patients undergoing ND for HNSCC .
CONCLUSIONS	Multicenter randomized studies need to be done to confirm the advantages of this technique and to evaluate the cost-benefit ratio .

###26019245
BACKGROUND	Pregnancy and lactation in adolescents with low calcium intake may impair fetal growth and infant bone mass .
OBJECTIVE	We investigated the effects of calcium plus vitamin D supplementation during pregnancy in Brazilian adolescent mothers consuming low calcium diets ( 600 mg/d ) on fetal biometry and infant bone mass , and the relation between infant and maternal bone mass during early lactation .
METHODS	Infants of mothers who received calcium ( 600 mg/d ) plus cholecalciferol ( 200 IU/d ) supplementation ( n = 30 ) or placebo ( n = 26 ) from 26 wk of gestation until parturition were studied .
METHODS	Fetal biometric measurements at 23 and 36 wk of gestation were obtained from medical records .
METHODS	Infant anthropometric and total body bone measurements [ bone mineral content ( BMC ) , bone area ( BA ) , and bone mineral density ( BMD ) ] at 5 wk postpartum were assessed by dual-energy X-ray absorptiometry .
METHODS	Maternal BMD z scores for total body , lumbar spine , total hip , and femoral neck at 5 wk postpartum were obtained .
METHODS	Group comparisons were adjusted for significant covariates .
RESULTS	Maternal mean serum 25-hydroxyvitamin D was 59 nmol/L at baseline in both groups .
RESULTS	No differences in fetal measurements at 36 wk of gestation were observed between the groups , except for body weight and its increment from 23 to 36 wk , which were higher in the supplemented group ( 6.8 % , P = 0.014 and 10.5 % , P = 0.07 , respectively ) .
RESULTS	Infant BMC ( 61.1 21.7 g ) , BA ( 167 79 cm ( 2 ) ) , and BMD ( 0.385 0.069 g/cm ( 2 ) ) did not significantly differ between the groups .
RESULTS	In the placebo group , infant BMC and BA were negatively correlated with maternal BMD z scores for total body ( r = -0.40 and r = -0.47 ; P < 0.05 ) and hip ( r = -0.41 and r = -0.46 ; P < 0.05 ) .
RESULTS	In contrast , no correlations were observed in the supplemented group .
CONCLUSIONS	Calcium and vitamin D supplementation of the adolescents studied resulted in higher fetal body weight at 36 wk of gestation and had no effect on infant bone mass at 5 wk postpartum .
CONCLUSIONS	Because correlations between maternal and infant bone mass were evident only in the placebo group , infant bone mass appeared to be more dependent on maternal skeletal mass when calcium intake was low .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01732328 .

###26154675
BACKGROUND	Skill readiness remains a challenge for all health care professionals who are involved in direct patient care .
BACKGROUND	Researchers suggest that skill retention may decrease within 6 months of an educational session .
BACKGROUND	The purpose of this study was to explore competency retention for high-risk , low-frequency procedures , specifically , managing a difficult airway and placing a laryngeal mask airway , using a web-based content refresher .
METHODS	The pilot study was conducted in two sessions .
METHODS	Session one established clinical skill competency .
METHODS	Six months later , the advanced practice RNs were randomized into two groups .
METHODS	Group 1 reviewed didactic content and participated in a complex airway management simulation .
METHODS	Group 2 participated only in a complex airway management simulation .
RESULTS	This study showed a positive trend in maintaining competency for a low-frequency procedure for which complex airway management was given , using web-based content review .
RESULTS	It is feasible to maintain competency for low-frequency procedures using web-based content refreshers .
CONCLUSIONS	This pilot study benefited advanced practice nurses by providing them with the potential to maintain competency in this high-risk , low-frequency procedure .
CONCLUSIONS	Continuing education is an important consideration for health care organizations .

###25106506
BACKGROUND	Breast cancer accounts for almost 30 % of all cancers and is the second leading cause of cancer deaths in women in Scotland .
BACKGROUND	Screening is key to early detection .
BACKGROUND	The Scottish Breast Screening Programme is a nationwide , free at point of delivery screening service , to which all women aged between 50 and 70 years are invited to attend every 3 years .
BACKGROUND	Currently over three-quarters of invited women regularly attend screening .
BACKGROUND	However , women from more deprived areas are much less likely to attend : for example in the 3 years from 2010-2012 only 63 % of women in the most deprived area attended the East of Scotland Breast Screening programme versus 81 % in the least deprived .
BACKGROUND	Research has suggested that reminders ( telephone or letter ) and brief , personalised interventions addressing barriers to attendance may be helpful in increasing uptake in low-income women .
METHODS	We will employ a brief telephone reminder and support intervention , whose purpose is to elicit and address any mistaken beliefs women have about breast screening , with the aim that the perceived benefits of screening come to outweigh any perceived barriers for individuals .
METHODS	We will test whether this intervention , plus a simple anticipated regret manipulation , will lead to an increase in the uptake of breast cancer screening amongst low-income women who have failed to attend a first appointment , in a randomised controlled trial with 600 women .
METHODS	Participants will be randomly allocated to one of four treatment arms i.e. 1 ) Letter reminder ( i.e. Treatment as usual : CONTROL ) ; 2 ) Telephone reminder ( TEL ) , 3 ) Telephone reminder plus telephone support ( TEL-SUPP ) and 4 ) Telephone reminder plus support plus AR ( TEL-SUPP-AR ) .
METHODS	The primary outcome will be attendance at breast screening within 3 months of the reminder letter .
CONCLUSIONS	If this simple telephone support intervention ( with or without AR intervention ) leads to a significant increase in breast screening attendance , this would represent a rare example of a theoretically-driven , relatively simple psychological intervention that could result in earlier detection of breast cancer amongst an under-served group of lower socio-economic women .
BACKGROUND	Current Controlled trials : ISRCTN06039270 .
BACKGROUND	Registered 16th January 2014 .

###25227830
BACKGROUND	Brief physician counselling has been shown to be effective in improving smokers ' behaviour .
BACKGROUND	If the counselling sessions can be given at the workplace , this would benefit a larger number of smokers .
BACKGROUND	This study aimed to determine the effectiveness of a ten-minute physician counseling session at the workplace in improving smoking behaviour .
METHODS	This prospective randomised control trial was conducted on smokers in a factory .
METHODS	A total of 163 participants were recruited and randomised into control and intervention groups using a table of random numbers .
METHODS	The intervention group received a ten-minute brief physician counselling session to quit smoking .
METHODS	Stages of smoking behaviour were measured in both groups using a translated and validated questionnaire at baseline , one month and three months post intervention .
RESULTS	There was a significant improvement in smoking behaviour at one-month post intervention ( p = 0.024 , intention to treat analysis ; OR = 2.525 ; CI = 1.109-5 .747 ) .
RESULTS	This was not significant at three-month post intervention ( p = 0.946 , intention to treat analysis ; OR = 1.026 ; 95 % CI = 0.486-2 .168 ) .
CONCLUSIONS	A session of brief physician counselling was effective in improving smokers ' behaviour at workplace , but the effect was not sustained .

###26181507
OBJECTIVE	Chronic tinnitus negatively affects the quality of life for millions of people .
OBJECTIVE	This clinical trial assesses a potential treatment for tinnitus .
OBJECTIVE	To determine if repetitive transcranial magnetic stimulation ( rTMS ) can reduce the perception or severity of tinnitus and to test the hypothesis that rTMS will result in a statistically significantly greater percentage of responders to treatment in an active rTMS group compared with a placebo rTMS group .
METHODS	A randomized , participant and clinician or observer-blinded , placebo-controlled clinical trial of rTMS involving individuals who experience chronic tinnitus .
METHODS	Follow-up assessments were conducted at 1 , 2 , 4 , 13 , and 26 weeks after the last treatment session .
METHODS	The trial was conducted between April 2011 and December 2014 at Portland Veterans Affairs Medical Center among 348 individuals with chronic tinnitus who were initially screened for participation .
METHODS	Of those , 92 provided informed consent and underwent more detailed assessments .
METHODS	Seventy individuals met criteria for inclusion and were randomized to receive active or placebo rTMS .
METHODS	Sixty-four participants ( 51 men and 13 women , with a mean [ SD ] age of 60.6 [ 8.9 ] years ) were included in the data analyses .
METHODS	No participants withdrew because of adverse effects of rTMS .
METHODS	Participants received 2000 pulses per session of active or placebo rTMS at a rate of 1-Hz rTMS daily on 10 consecutive workdays .
METHODS	The Tinnitus Functional Index ( TFI ) was the main study outcome .
METHODS	Our hypothesis was tested by comparing baseline and posttreatment TFIs for each participant and group .
RESULTS	Overall , 18 of 32 participants ( 56 % ) in the active rTMS group and 7 of 32 participants ( 22 % ) in the placebo rTMS group were responders to rTMS treatment .
RESULTS	The difference in the percentage of responders to treatment in each group was statistically significant ( ( 1 ) ( 2 ) = 7.94 , P < .005 ) .
CONCLUSIONS	Application of 1-Hz rTMS daily for 10 consecutive workdays resulted in a statistically significantly greater percentage of responders to treatment in the active rTMS group compared with the placebo rTMS group .
CONCLUSIONS	Improvements in tinnitus severity experienced by responders were sustained during the 26-week follow-up period .
CONCLUSIONS	Before this procedure can be implemented clinically , larger studies should be conducted to refine treatment protocols .
BACKGROUND	clinicaltrials.gov Identifier : NCT01104207 .

###26442395
BACKGROUND	The aim of the current study was to compare block of the sciatic nerve through the anterior approach by two methods , namely , the nerve-stimulator guided and ultrasound-guided , with or without nerve stimulation , with regard to the ease of performance , reliability and safety of this approach .
METHODS	36 adult patients were randomly allocated equally into one of 2 main groups : `` Nerve Stimulator-Guided Group ( NSG ) '' where the nerve was located by nerve stimulator only and `` Ultrasound guided group ( USG ) '' where the sciatic nerves were blocked by a stimulated needle under guidance of the ultrasound .
METHODS	Assessment of performing each technique , sensory and motor blockades , occurrence of acute systemic toxicity and haematoma formation were compared .
RESULTS	Only one-third of the sciatic nerves could be visualized by US .
RESULTS	This did not affect the block execution time but caused less number of needle passes in a statistically significant value .
RESULTS	Sensory and motor block showed significant differences between the 2 groups .
RESULTS	Criteria of acute systemic toxicity and occurrence of hematoma were not reported in both groups .
CONCLUSIONS	Results of the current study showed that the addition of ultrasound to nerve stimulator in the anterior approach to the sciatic nerve block added only little to the ease of performance , reliability and safety .
CONCLUSIONS	This was because only one-third of the nerves could be seen .
CONCLUSIONS	More practice , better machines and new blocking techniques may be needed to overcome the problem of anisotropy of the nerve .

###24493730
OBJECTIVE	To investigate how radiotherapy ( XRT ) adds to tumor control using a standardized surgical technique with meticulous control of surgical margins in a randomized trial with 20 years of follow-up .
METHODS	Three hundred eighty-one women with pT1N0 breast cancer were randomly assigned to sector resection with ( XRT group ) or without ( non-XRT group ) postoperative radiotherapy to the breast .
METHODS	With follow-up through 2010 , we estimated cumulative proportion of recurrence , breast cancer death , and all-cause mortality .
RESULTS	The cumulative probability of a first breast cancer event of any type after 20 years was 30.9 % in the XRT group and 45.1 % in the non-XRT group ( hazard ratio [ HR ] , 0.58 ; 95 % CI , 0.41 to 0.82 ) .
RESULTS	The benefit of radiotherapy was achieved within the first 5 years .
RESULTS	After 20 years , 50.4 % of the women in the XRT group died compared with 54.0 % in the non-XRT group ( HR , 0.92 ; 95 % CI , 0.71 to 1.19 ) .
RESULTS	The cumulative probability of contralateral cancer or death as a result of cancer other than breast cancer was 27.1 % in the XRT group and 24.9 % in the non-XRT group ( HR , 1.17 ; 95 % CI , 0.77 to 1.77 ) .
RESULTS	In an anticipated low-risk group , the cumulative incidence of first breast cancer of any type was 24.8 % in the XRT group and 36.1 % in the non-XRT group ( HR , 0.61 ; 95 % CI , 0.35 to 1.07 ) .
CONCLUSIONS	Radiotherapy protects against recurrences during the first 5 years of follow-up , indicating that XRT mainly eradicates undetected cancer foci present at primary treatment .
CONCLUSIONS	The similar rate of recurrences beyond 5 years in the two groups indicates that late recurrences are new tumors .
CONCLUSIONS	There are subgroups with clinically relevant differences in risk .

###24632426
OBJECTIVE	Patients undergoing cardiac surgery presenting with chronic obstructive pulmonary disease ( COPD ) have a higher 30-day mortality risk .
OBJECTIVE	In these patients , pulmonary dysfunction linked to an inflammatory response is frequent after cardiac operations using cardiopulmonary bypass ( CPB ) , which causes pulmonary hypoperfusion .
OBJECTIVE	We hypothesize that selective pulmonary perfusion ( sPP ) of the lungs leads to a reduction of pulmonary inflammation and a better clinical outcome .
METHODS	Fifty-nine COPD patients ( forced expiratory volume in 1 s/vital capacity < 70 % ) undergoing cardiac surgery procedures ( coronary artery bypass grafting 64 % , valve 14 % ) were block-randomized to sPP ( venous blood , temperature 2C , 4 l ) or standard CPB ( 28/28 ) .
METHODS	The primary end-point of the study was to evaluate the effect of pulmonary perfusion on gas exchange by measuring alveolar-arterial oxygen gradient .
METHODS	The surrogate end-points were inflammatory response , intensive care unit ( ICU ) stay , time on respirator ( TOR ) and major adverse cardiac and cerebrovascular events .
METHODS	A cytokine assay for interleukin-1 , IL-6 , IL-10 , tumour necrosis factor - ( TNF - ) and polymorphonuclear elastase was performed with peripheral blood at different time-points [ ( t1 ) pre-CPB , ( t2 ) end of CPB , ( t3 ) 3 h , ( t4 ) 24 h , ( t5 ) 48 h postoperatively ] .
METHODS	Repeated-measure analysis of variance and non-parametric statistics were used to assess the between-group and during time differences .
RESULTS	The two groups proved comparable for perioperative variables .
RESULTS	Serum cytokines were not different in the two groups throughout the study ( P > 0.05 at single time-points ) , but as a function of time , the markers of the inflammatory response increased after CBP ( P < 0.05 pre-CPB to 24 h ) .
RESULTS	Clinical end-points were statistically comparable in both groups , but with a trend towards a shorter TOR ( 72 159 h/106 193 h ) and ICU stay ( 3.9 7.2 days/5 .5 9.2 days ) in the sPP group despite a slightly longer time on extracorporeal circulation ( 120 vs 158 min ) .
CONCLUSIONS	These results indicate a non-significant trend that repeated hypothermic lung perfusion with venous blood during CPB may have a protective effect on the lungs .
CONCLUSIONS	A multicentre study design and larger cohort seem necessary to demonstrate the benefits of sPP more clearly .

###25187755
BACKGROUND	This study compared efficacy and safety of the selective relaxant binding agent sugammadex ( 2mg/kg ) with neostigmine ( 50g/kg ) for neuromuscular blockade ( NMB ) reversal in Chinese and Caucasian subjects .
METHODS	This was a randomized , active-controlled , multicenter , safety-assessor-blinded study ( NCT00825812 ) in American Society of Anesthesiologists Class 1-3 subjects undergoing surgery with propofol anesthesia .
METHODS	Rocuronium 0.6 mg/kg was administered for endotracheal intubation , with 0.1-0 .2 mg/kg maintenance doses given as required .
METHODS	NMB was monitored using TOF-Watch ( ) SX .
METHODS	At second twitch reappearance , after last rocuronium dose , subjects received sugammadex 2mg/kg or neostigmine 50g/kg plus atropine 10-20g / kg , according to randomization .
METHODS	Primary efficacy variable was time from sugammadex/neostigmine to recovery of the train-of-four ( TOF ) ratio to 0.9 .
RESULTS	Overall , 230 Chinese subjects ( sugammadex , n = 119 , neostigmine , n = 111 ) ; and 59 Caucasian subjects ( sugammadex , n = 29 , neostigmine , n = 30 ) had evaluable data .
RESULTS	Geometric mean ( 95 % CI ) time to recovery to TOF ratio 0.9 was 1.6 ( 1.5-1 .7 ) min with sugammadex vs 9.1 ( 8.0-10 .3 ) min with neostigmine in Chinese subjects .
RESULTS	Corresponding times for Caucasian subjects were 1.4 ( 1.3-1 .5 ) min and 6.7 ( 5.5-8 .0 ) min , respectively .
RESULTS	Sugammadex 2mg/kg was generally well tolerated , with no serious adverse events reported .
RESULTS	There was no residual NMB or recurrence of NMB .
CONCLUSIONS	Both Chinese and Caucasian subjects recovered from NMB significantly faster after sugammadex 2mg/kg vs neostigmine 50g/kg , with a ~ 5.7 times ( p < 0.0001 ) faster recovery with sugammadex vs neostigmine in Chinese subjects .
CONCLUSIONS	Sugammadex was generally well tolerated .
BACKGROUND	ClinicalTrials.gov Identifier : NCT00825812 .

###24737415
BACKGROUND	Little is known about the factors that predict for gastrointestinal stromal tumor ( GIST ) recurrence in patients treated with adjuvant imatinib .
METHODS	Risk factors for GIST recurrence were identified , and 2 risk stratification scores were developed using the database of the Scandinavian Sarcoma Group ( SSG ) XVIII trial , where 358 patients with high-risk GIST with no overt metastases were randomly assigned to adjuvant imatinib 400 mg/day either for 12 or 36 months after surgery .
METHODS	The findings were validated in the imatinib arm of the American College of Surgeons Oncology Group Z9001 trial , where 359 patients with GIST were randomized to receive imatinib and 354 were to receive placebo for 12 months .
RESULTS	Five factors ( high tumor mitotic count , nongastric location , large size , rupture , and adjuvant imatinib for 12 months ) were independently associated with unfavorable recurrence-free survival ( RFS ) in a multivariable analysis in the SSGXVIII cohort .
RESULTS	A risk score based on these 5 factors had a concordance index with GIST recurrence of 78.9 % .
RESULTS	When a simpler score consisting of the 2 strongest predictive factors ( mitotic count and tumor site ) was devised , the groups with the lowest , intermediate high , and the highest risk had 5-year RFS of 76.7 % , 47.5 % , and 8.4 % , respectively .
RESULTS	Both scores were strongly associated with RFS in the validation cohort ( P < .001 for each comparison ) .
CONCLUSIONS	The scores generated were effective in stratifying the risk of GIST recurrence in patient populations treated with adjuvant imatinib .
CONCLUSIONS	Patients with nongastric GIST with a high mitotic count are at a particularly high risk for recurrence .

###25067790
OBJECTIVE	To evaluate both the short - and long-term effectiveness of a lifestyle intervention on physical fitness in adolescents and young adults with cerebral palsy ( CP ) .
METHODS	Single-blind , randomized controlled trial .
METHODS	University hospitals and rehabilitation clinics .
METHODS	Adolescents and young adults ( N = 57 ) with spastic CP classified in Gross Motor Function Classification System levels I through IV ; of these , 42 completed the study .
METHODS	A 6-month lifestyle intervention consisting of physical fitness training combined with counseling sessions focused on physical behavior and sports participation .
METHODS	Physical fitness , including measures of cardiopulmonary fitness , muscle strength , and body composition .
RESULTS	Favorable short - and medium-term effects were found for peak oxygen consumption , oxygen consumption , and load on the anaerobic threshold and waist circumference .
RESULTS	Favorable long-term effects were found for sum of skinfolds , systolic blood pressure , and total cholesterol .
CONCLUSIONS	This exploratory study showed that the lifestyle intervention was effective in improving cardiopulmonary fitness and body composition .
CONCLUSIONS	Effects of body composition were maintained in the long term .
CONCLUSIONS	However , the intervention needs to be optimized to increase muscle strength and for long-term retention of effects on aerobic capacity .

###25413133
BACKGROUND	Arterial and thromboembolic pulmonary hypertension ( PH ) lead to arterial hypoxaemia .
OBJECTIVE	To investigate whether cerebral tissue oxygenation ( CTO ) in patients with PH is reduced and whether this is associated with reduced exercise tolerance .
METHODS	16 patients with PH ( mean pulmonary arterial pressure 25 mmHg , 14 arterial , 2 chronic thromboembolic ) and 15 controls underwent right heart catheterisation with monitoring of CTO at rest , during maximal bicycle exercise and during inhalation of oxygen and NO .
METHODS	The 6 min walk distance ( 6MWD ) was measured .
RESULTS	Median CTO in PH-patients at rest was 62 % ( quartiles 53 ; 71 ) , during exercise 60 % ( 53 ; 65 ) ; corresponding values in controls were 65 % ( 73 ; 73 ) ( P = NS ) and 68 % ( 66 ; 70 ) ( p = .013 vs. PH ) .
RESULTS	Inhalation of NO and oxygen improved CTO in PH. In multivariate regression analysis CTO at maximal exercise predicted the work load achieved when controlled for age , pulmonary vascular resistance and mixed venous oxygen saturation ( R ( 2 ) = .419 , p < .000 ) ; in addition , the 6MWD was predicted by CTO ( adjusted R ( 2 ) = .511 , p < .000 ) .
CONCLUSIONS	In PH-patients but not in controls CTO decreased during exercise .
CONCLUSIONS	Since CTO was an independent predictor of the work load achieved and the 6MWD cerebral hypoxia may contribute to exercise limitation in PH. Clinicaltrials.gov : NCT01463514 .

###25609264
BACKGROUND	A lipid emulsion composed of soybean oil ( long-chain triglycerides , LCT ) , medium-chain triglycerides ( MCT ) and n-3 poly-unsaturated fatty acids ( PUFAs ) was evaluated for immune-modulation efficacy , safety , and tolerance in patients undergoing major surgery for gastric and colorectal cancer .
METHODS	In a prospective , randomized , double-blind study , 99 patients with gastric and colorectal cancer receiving elective surgery were recruited and randomly assigned to either the study group , receiving the n-3 PUFAs enriched intravenous fat emulsion ( IVFE ) , or the control group , receiving a lipid emulsion comprised of soybean oil and MCTs ( 0.8 - 1.5gkg-1day-1 ) as part of total parenteral nutrition ( TPN ) regimen from surgery ( day -1 ) up to post-operative day 7 .
METHODS	Safety and efficacy parameters were assessed on day -1 and post-operative visits on day 1 , 3 , and 7 .
METHODS	Adverse events were documented daily and compared between the groups .
RESULTS	Pro-inflammatory markers , laboratory parameters , and adverse events did not differ prominently between the 2 groups , with the exception of net changes ( day 7 minus day -1 ) of free fatty acids ( FFAs ) , triglyceride , and high-density lipoprotein ( HDL ) .
RESULTS	Net decrease of FFAs was remarkably higher in the study group , while the net increase of triglyceride and decrease of HDL was significantly lower .
CONCLUSIONS	The n-3 PUFA-enriched IVFE showed improvements in lipid metabolism .
CONCLUSIONS	In respect of efficacy , safety and tolerance both IVFE were comparable .
CONCLUSIONS	In patients with severe stress , there is an inflammation-attenuating effect of n-3 PUFAs .
CONCLUSIONS	Further , adequately powered clinical trials will be necessary to address this question in postsurgical GI cancer patients .
BACKGROUND	US ClinicalTrials.gov NCT00798447 .

###26016870
BACKGROUND	Butter is rich in saturated fat [ saturated fatty acids ( SFAs ) ] and can increase plasma low density lipoprotein ( LDL ) cholesterol , which is a major risk factor for cardiovascular disease .
BACKGROUND	However , compared with other dairy foods , butter is low in milk fat globule membrane ( MFGM ) content , which encloses the fat .
BACKGROUND	We hypothesized that different dairy foods may have distinct effects on plasma lipids because of a varying content of MFGM .
OBJECTIVE	We aimed to investigate whether the effects of milk fat on plasma lipids and cardiometabolic risk markers are modulated by the MFGM content .
METHODS	The study was an 8-wk , single-blind , randomized , controlled isocaloric trial with 2 parallel groups including overweight men and women ( n = 57 randomly assigned ) .
METHODS	For the intervention , subjects consumed 40 g milk fat/d as either whipping cream ( MFGM diet ) or butter oil ( control diet ) .
METHODS	Intervention foods were matched for total fat , protein , carbohydrates , and calcium .
METHODS	Subjects were discouraged from consuming any other dairy products during the study .
METHODS	Plasma markers of cholesterol absorption and hepatic cholesterol metabolism were assessed together with global gene-expression analyses in peripheral blood mononuclear cells .
RESULTS	As expected , the control diet increased plasma lipids , whereas the MFGM diet did not [ total cholesterol ( SD ) : +0.30 0.49 compared with -0.04 0.49 mmol/L , respectively ( P = 0.024 ) ; LDL cholesterol : +0.36 0.50 compared with +0.04 0.36 mmol/L , respectively ( P = 0.024 ) ; apolipoprotein B : apolipoprotein A-I ratio : +0.03 0.09 compared with -0.05 0.10 mmol/L , respectively ( P = 0.007 ) ; and non-HDL cholesterol : +0.24 0.49 compared with -0.14 0.51 mmol/L , respectively ( P = 0.013 ) ] .
RESULTS	HDL-cholesterol , triglyceride , sitosterol , lathosterol , campesterol , and proprotein convertase subtilisin/kexin type 9 plasma concentrations and fatty acid compositions did not differ between groups .
RESULTS	Nineteen genes were differentially regulated between groups , and these genes were mostly correlated with lipid changes .
CONCLUSIONS	In contrast to milk fat without MFGM , milk fat enclosed by MFGM does not impair the lipoprotein profile .
CONCLUSIONS	The mechanism is not clear although suppressed gene expression by MFGM correlated inversely with plasma lipids .
CONCLUSIONS	The food matrix should be considered when evaluating cardiovascular aspects of different dairy foods .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01767077 .

###24673054
OBJECTIVE	To observe differences of therapeutic effect between acupuncture combined with bloodletting and regular western medication on chronic urticarial .
METHODS	One hundred and sixty patients were randomly divided into an acupuncture bloodletting group and a loratadine group , 80 cases in each group .
METHODS	In the acupuncture bloodletting group , Quchi ( LI 11 ) , Neiguan ( PC 6 ) , Xuehai ( SP 10 ) and Sanyinjiao ( SP 6 ) were selected and manipulated with reducing method , and pricking bloodletting with three-edge needle and cupping were given at Feishu ( BL 13 ) and Geshu ( BL 17 ) , once every other day .
METHODS	The oral administration of 10 mg loratadine was applied in the loratadine group , once a day .
METHODS	The therapeutic effect in two groups was observed and compared after four weeks .
RESULTS	The cured and markedly effective rate was 91.3 % ( 73/80 ) in the acupuncture bloodletting group , which was similar to 81.3 % ( 65/80 ) in the loratadine group ( P > 0.05 ) .
RESULTS	The scores of symptom-sign in the two groups were reduced after treatment ( 10.14 + / - 1.95 vs 2.12 + / - 40.32 , 10.30 + / - 1.82 vs 3.21 + / - 0.28 , both P < 0.01 ) , but there was no statistically significant difference between two groups after treatment ( P > 0.05 ) .
RESULTS	There was no obvious adverse effect in the acupuncture bloodletting group while 3 cases of mild somnolence were reported in the loratadine group .
CONCLUSIONS	The acupuncture bloodletting is an effective method for chronic urticarial , which has similar effect to loratadine without adverse effect .

###25948437
BACKGROUND	Reducing the wound healing time is crucial in wound as it lowers the chance of infection and decreases complications and cost .
BACKGROUND	Grape seed extract has the ability to release endothelial growth factor and its topical application results in contraction and closure of the skin wound .
BACKGROUND	Furthermore , it possesses antioxidant and antibacterial properties .
BACKGROUND	In several studies it has been proved effective in animals .
BACKGROUND	Therefore , due to low side effects and recognition of herbal medicine , we decided to evaluate the effect of grape seed extract 2 % herbal cream on human skin lesions .
METHODS	This study is a double blind clinical trial conducted on two groups of treatment and placebo .
METHODS	Surgery was performed on skin lesions such as skin tags and moles which were found on the neck , trunk and limbs ( except for face ) .
METHODS	After enrollment and obtaining informed consent from participants , they were randomized into two groups of treatment and placebo .
METHODS	Excision of the lesions was done by surgical scissors .
METHODS	The lesions got restored by secondary intention method .
METHODS	After the first day of treatment , the patients were visited on the 3rd , 7th , 10th , 14th , and 21st day .
METHODS	Grape seed extract cream 2 % was produced and coded by the Faculty of Pharmacy , Ahvaz University of Medical Sciences .
METHODS	In order to compare the two groups , T-test was used .
METHODS	For time assessing , analysis of variance with repeated measures was employed .
RESULTS	The results showed complete repair of wounds averagely on day 8 for the treatment group and on day 14 for the placebo group , which was clearly significant in terms of statistical difference ( p = 0.00 ) .
CONCLUSIONS	Proanthocyanidins in grape seed extract trigger the release of vascular endothelial growth factor and its topical application causes wound contraction and closure .
CONCLUSIONS	Curing skin lesions with grape seed extract caused proliferation areas with protected boundaries in epithelium , increased cell density and increased deposition of connective tissue at the wound site which in general improves cellular structure in wound .
CONCLUSIONS	In addition , its anti-inflammatory and anti-microbial properties are effective in wound healing .

###24820104
BACKGROUND	We tested if an increase in immune activation and a decrease in CD4 T cells induced by different antigenic stimuli could be associated with changes in the thymic function and the interleukin ( IL ) -7 / CD127 system .
METHODS	Twenty-six HIV-infected patients under combined antiretroviral therapy ( cART ) were randomized to receive , during 12 months , a complete immunization schedule ( 7 vaccines and 15 doses ) or placebo .
METHODS	Thereafter , cART was interrupted during 6 months .
METHODS	Changes in the thymic function and the IL-7 / CD127 system after 3 different antigenic stimuli ( vaccines , episodes of low-level intermittent viremia before cART interruption , or viral load rebound after cART interruption ) were assessed .
RESULTS	During the period on cART , neither vaccines nor low-level viremia influenced thymic function or IL-7 / CD127 system parameters .
RESULTS	By analyzing the cohort as a whole while on cART , a significant improvement was observed in the thymic function as measured by an increase in the thymic volume ( P = 0.024 ) , T-cell receptor excision circle-bearing cells ( P = 0.012 ) , and naive CD4 and CD8 T cells ( P = 0.069 both ) .
RESULTS	No significant changes were observed in the IL-7 / CD127 system .
RESULTS	After cART interruption , a decrease in T-cell receptor excision circles ( P < 0.001 ) and naive CD8 T cells ( P < 0.001 ) , an increase in IL-7 and expression of CD127 on naive and memory CD4 T cells ( P = 0.028 , P = 0.088 , and P = 0.04 , respectively ) , and a significant decrease in CD127 on naive and memory CD8 T cells ( P = 0.01 , P = 0.006 , respectively ) were observed .
CONCLUSIONS	Low-level transient antigenic stimuli during cART were not associated with changes in the thymic function or the IL-7 / CD127 system .
CONCLUSIONS	Conversely , viral load rebound very early after cART interruption influenced the thymic function and the IL-7 / CD127 system .
CONCLUSIONS	Clinical Trials.gov number NCT00329251 .

###25332252
OBJECTIVE	We have previously shown that the PAM50-based risk of recurrence ( ROR ) score is significantly correlated with distant recurrence in both the translational research cohort within the Arimidex , Tamoxifen Alone or in Combination ( ATAC ) trial ( TransATAC ) and Austrian Breast and Colorectal Cancer Study Group 8 ( ABCSG 8 ) randomized trials .
OBJECTIVE	Here , we focus on the ROR score for predicting distant recurrence after 5 years of follow-up in a combined analysis of these two randomized trials .
METHODS	Long-term follow-up data and tissue samples were obtained from 2,137 postmenopausal women with hormone receptor-positive early-stage breast cancer from the ABCSG 8 and TransATAC trials .
METHODS	We used Cox proportional hazard regression models to determine the prognostic value of ROR for distant recurrence beyond 5 years in the combined data set .
RESULTS	A total of 2,137 women who did not have a recurrence 5 years after diagnosis were included in the combined analyses .
RESULTS	The Clinical Treatment Score ( CTS ) was the strongest prognostic factor 5 years after diagnosis ( univariable : likelihood ratio [ LR ] ( 2 ) = 94.12 , bivariable : LR ( 2 ) = 61.43 ) .
RESULTS	The ROR score was significantly prognostic by itself in years 5 to 10 .
RESULTS	In the node-negative/human epidermal growth factor receptor 2-negative subgroup , more prognostic value for late distant recurrence was added by the ROR score compared with the CTS .
CONCLUSIONS	The ROR score added clinically meaningful prognostic information to the CTS in all patients and all subgroups in the late follow-up period .
CONCLUSIONS	These results suggest that the ROR score may be helpful for separating patients into risk groups who could be spared or potentially benefit from extended hormonal therapy beyond 5 years of treatment .

###25028082
OBJECTIVE	This study measured the effects of dietary supplementation with lipid-based nutrient supplements ( LNSs ) on 18-month-old children 's physical activity .
METHODS	In a randomised , controlled , outcome-assessor blinded trial 1932 six-month-old children from Malawi received one of five interventions daily from 6-18 months of age : 10-g milk-LNS , 20-g milk-LNS , 20-g non-milk-LNS , 40-g milk-LNS or 40-g non-milk-LNS , or received no intervention in the same period ( control ) .
METHODS	The control group received delayed intervention with corn-soy blend from 18-30 months .
METHODS	Physical activity was measured over 1 week by ActiGraph GT3X + accelerometer at 18 months .
METHODS	Main outcome was mean vector magnitude accelerometer counts/15s .
METHODS	Analyses were restricted to children with valid accelerometer data on at least 4 days with minimum 6h of wearing time per day .
RESULTS	Of the 1435 children recruited to this substudy , 1053 provided sufficient data for analysis .
RESULTS	The mean ( s.d. ) vector magnitude accelerometer counts in the total sample were 307 ( 64 ) .
RESULTS	The difference ( 95 % CI ) in mean accelerometer counts , compared with the control group , was 8 ( -6 to 21 , P = 0.258 ) in 10-g milk-LNS , 3 ( -11 to 17 , P = 0.715 ) in 20-g milk-LNS , 5 ( -8 to 19 , P = 0.445 ) in 20-g non-milk-LNS , 10 ( -3 to 23 , P = 0.148 ) in 40-g milk-LNS and 2 ( -12 to 16 , P = 0.760 ) in 40-g non-milk-LNS groups .
CONCLUSIONS	Provision of 10-40g doses of LNS daily for 12 months did not increase physical activity of Malawian toddlers .

###25794603
OBJECTIVE	To present the impact of treatments on health-related quality of life ( HRQoL ) from the double-blind , randomised phase III COMBI-d study that investigated the combination of dabrafenib and trametinib versus dabrafenib monotherapy in patients with BRAF V600E/K-mutant metastatic melanoma .
OBJECTIVE	COMBI-d showed significantly prolonged progression-free survival for the combination .
METHODS	HRQoL was evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 , a generic cancer questionnaire ( completed at baseline , during study treatment , at progression and post progression ) assessing various dimensions ( global health/QoL , functional status , and symptom impact ) .
METHODS	A mixed-model , repeated-measures analyses of covariance evaluated differences between arms .
RESULTS	Questionnaire completion rates were > 95 % at baseline , > 85 % to week 40 and > 70 % at disease progression .
RESULTS	Baseline scores across both arms were comparable for all dimensions .
RESULTS	Global health dimension scores were significantly better at weeks 8 , 16 and 24 for patients receiving the combination during treatment and at progression .
RESULTS	The majority of functional dimension scores ( physical , social , role , emotional and cognitive functioning ) trended in favour of the combination .
RESULTS	Pain scores were significantly improved and clinically meaningful ( 6-13 point difference ) for patients receiving the combination for all follow-up assessments versus those receiving dabrafenib monotherapy .
RESULTS	For other symptom dimensions ( nausea and vomiting , diarrhoea , dyspnoea , and constipation ) , scores trended in favour of dabrafenib monotherapy .
CONCLUSIONS	This analysis demonstrates that the combination of dabrafenib and trametinib provides better preservation of HRQoL and pain improvements versus dabrafenib monotherapy while also delaying progression .
CONCLUSIONS	( Clinicaltrials.gov registration number : NCT01584648 ) .

###24885396
BACKGROUND	The treatment of large ( 10-25mm ) or giant ( 25mm ) cerebral aneurysms remains technically challenging , with a much higher complication and recanalization rate than that is observed for smaller aneurysms .
BACKGROUND	The use of a flow diverter seems to facilitate the treatment of this special entity .
BACKGROUND	In a previous single-center prospective study approved by the Ethics Committee and China Food and Drug Administration ( CFDA ) , we obtained promising results , showing remarkable safety and effectiveness for the Tubridge flow diverter .
BACKGROUND	Nevertheless , the previous study may have been limited by biases due to its single-center design and limited number of subjects .
BACKGROUND	Furthermore , although various articles have reported durable results from treating aneurysms using flow diverters , increasing questions have arisen about this form of treatment .
BACKGROUND	Thus , prospective , multiple-center , randomized trials containing more subjects are needed .
METHODS	This study is a multicenter , randomized , controlled clinical trial comparing clinical outcomes for patients with unruptured large/giant intracranial aneurysms treated with either conventional stent-assisted coiling or flow diverter implantation .
METHODS	A total of 124 patients who fulfill the inclusion and exclusion criteria will be randomized into either a treatment group or a control group in the ratio of 1:1 .
METHODS	The treatment group will receive Tubridge implantation alone or combined with bared coils , and the control group will be treated with stent-assisted coiling ( bare coils ) .
METHODS	The primary endpoint will be the complete occlusion rate at 6-month follow-up .
METHODS	Secondary endpoints include the immediate technique success rate , overall mortality , adverse events ( ischemic stroke or intracranial bleeding ) within 30days , 90days and 1year post-operation , and the rate of intra-stent stenosis and thrombosis 6months post-operation .
CONCLUSIONS	This prospective trial may provide more information on the safety and efficacy of the Tubridge flow diverter and may potentially change the strategy for treatment of large or giant aneurysms .
BACKGROUND	The trial is registered on the Chinese Clinical Trial Registry : ChiCTR-TRC-13003127 .

###24443845
BACKGROUND	The prevalence of obesity in men in the UK is amongst the highest in Europe but men are less likely than women to use existing weight loss programmes .
BACKGROUND	Developing weight management programmes which are appealing and acceptable to men is a public health priority .
BACKGROUND	Football Fans in Training ( FFIT ) , a men-only weight management programme delivered to groups of men at top professional football clubs , encourages men to lose weight by working with , not against , cultural ideals of masculinity .
BACKGROUND	To inform further development of interventions in football club settings , the current study explored who is attracted to FFIT and why overweight/obese men choose to take part .
METHODS	A mixed-methods study analysing baseline data on 747 men aged 35-65years with BMI28kg/m2 who were participants in a randomised controlled trial of FFIT , and data from 13 focus group discussions with 63 men who had attended the programme .
RESULTS	Objectively-measured mean body mass index was 35.3 kg/m2 ( sd 4.9 ) .
RESULTS	Overall over 90 % of participants were at very high or extremely high risk of future ill-health .
RESULTS	Around three-quarters of participants in all age groups were at ` very high ' risk of type 2 diabetes , hypertension and cardiovascular disease ( 72 % , 73 % and 80 % of men aged 35-44 , 45-54 and 55-64years respectively ) .
RESULTS	A further 21 % , 16 % and 13 % were at ` extremely high ' risk .
RESULTS	Qualitative data revealed that the powerful ` draw ' of the football club attracted men otherwise reluctant to attend existing weight management programmes .
RESULTS	The location and style of delivery of early FFIT sessions fostered team spirit ; men appreciated being with others ` like them ' and the opportunity to undertake weight management in circumstances that enhanced physical and symbolic proximity to something they valued highly , the football club .
CONCLUSIONS	The delivery of a weight management intervention via professional football clubs attracted men at high risk of ill-health .
CONCLUSIONS	The setting enabled men to join a weight management programme in circumstances that felt ` right ' rather than threatening to themselves as men .
CONCLUSIONS	FFIT is an example of how to facilitate health promotion activities in a way that is consistent with , rather than challenging to , common ideals of masculinity .

###24421235
OBJECTIVE	To evaluate the efficacy of sequential enteral nutrition support in patients with severe cerebral stroke .
METHODS	Forty-nine patients with severe cerebral stroke met the inclusion criteria were randomly divided into sequential enteral nutrition group ( Group A , n = 24 ) and conventional enteral nutrition group ( Group B , n = 25 ) .
METHODS	Patients in Group A received short-peptide-based enteral nutrition support first , then gradually transferred to intact protein enteral nutrition .
METHODS	Meanwhile , patients in Group B constantly received intact protein enteral nutrition support .
METHODS	The nutritional indexes and the rate of complications were compared between two groups .
RESULTS	The nutritional indexes were decreased in both groups within 4 weeks after admission , but the decreasing levels of hemoglobin and albumin in Group A were significantly lower than those in Group B ( P < 0.05 ) , and the incidence of infections and gastrointestinal hemorrhage in Group A was also lower than that in Group B ( P < 0.05 ) .
RESULTS	However , there were no significant differences in body weight , BMI , triceps skinfold thickness , biceps circumference , arm muscle circumference between two groups ( P > 0.05 ) .
CONCLUSIONS	Sequential enteral nutritional support can improve the nutritional status and decrease the incidence of complications in critical patients with cerebral stroke .

###25985734
OBJECTIVE	There are no effective and safe treatments for chronic hepatitis C virus ( HCV ) infection of patients who have advanced liver disease .
METHODS	In this phase 2 , open-label study , we assessed treatment with the NS5A inhibitor ledipasvir , the nucleotide polymerase inhibitor sofosbuvir , and ribavirin in patients infected with HCV genotypes 1 or 4 .
METHODS	Cohort A enrolled patients with cirrhosis and moderate or severe hepatic impairment who had not undergone liver transplantation .
METHODS	Cohort B enrolled patients who had undergone liver transplantation : those without cirrhosis ; those with cirrhosis and mild , moderate , or severe hepatic impairment ; and those with fibrosing cholestatic hepatitis .
METHODS	Patients were assigned randomly ( 1:1 ) to receive 12 or 24 weeks of a fixed-dose combination tablet containing ledipasvir and sofosbuvir , once daily , plus ribavirin .
METHODS	The primary end point was sustained virologic response at 12 weeks after the end of treatment ( SVR12 ) .
RESULTS	We enrolled 337 patients , 332 ( 99 % ) with HCV genotype 1 infection and 5 ( 1 % ) with HCV genotype 4 infection .
RESULTS	In cohort A ( nontransplant ) , SVR12 was achieved by 86 % -89 % of patients .
RESULTS	In cohort B ( transplant recipients ) , SVR12 was achieved by 96 % -98 % of patients without cirrhosis or with compensated cirrhosis , by 85 % -88 % of patients with moderate hepatic impairment , by 60 % -75 % of patients with severe hepatic impairment , and by all 6 patients with fibrosing cholestatic hepatitis .
RESULTS	Response rates in the 12-and 24-week groups were similar .
RESULTS	Thirteen patients ( 4 % ) discontinued the ledipasvir and sofosbuvir combination prematurely because of adverse events ; 10 patients died , mainly from complications related to hepatic decompensation .
CONCLUSIONS	The combination of ledipasvir , sofosbuvir , andribavirin for 12 weeks produced high rates of SVR12 in patients with advanced liver disease , including those with decompensated cirrhosis before and after liver transplantation .
CONCLUSIONS	ClinTrials.gov : NCT01938430 .

###24833256
BACKGROUND	Secondary peritonitis is an advanced form of complicated intra-abdominal infection ( cIAI ) requiring hospitalization , surgical source control , and empiric antibiotic therapy against causative aerobic and anaerobic bacteria .
METHODS	This pooled analysis of four prospective , active-controlled randomized clinical trials compared the efficacy and safety of moxifloxacin with that of comparator antibiotics in patients with confirmed secondary peritonitis .
METHODS	The primary efficacy endpoint was clinical success rate at test-of-cure ( TOC ) between day 10 and 45 post-therapy in the per-protocol ( PP ) population .
METHODS	Safety and clinical efficacy were assessed also in the intent-to-treat population ( ITT ) .
METHODS	Bacteriological success was assessed at TOC in the microbiologically-valid population as a secondary efficacy endpoint .
RESULTS	Overall clinical success rates at TOC were 85.3 % ( 431 of 505 patients ) in the moxifloxacin and 88.4 % ( 459 of 519 patients ) in the comparator treatment groups ( PP population , point estimate for the difference in success rates : -3.0 % ; 95 % CI -7.06 % , 1.05 % ) , respectively .
RESULTS	Similar clinical success rates between moxifloxacin and comparators were observed by anatomical site of infection , and ranged from 80.6 % to 100 % for moxifloxacin and from 71.4 % to 96.6 % for comparators , respectively .
RESULTS	Bacteriologic success rates were similar with moxifloxacin ( 82.4 % ) and comparators ( 86.8 % ) , respectively .
RESULTS	The proportion of patients experiencing any treatment-emergent adverse events was slightly higher with moxifloxacin ( 67.3 % ) versus comparators ( 59.8 % ) .
RESULTS	Rates of drug-related adverse events ( 20.9 % versus 20.0 % ) and deaths ( 4.3 % versus 3.4 % ) were similar in moxifloxacin and comparator groups ; none of the deaths were drug-related .
CONCLUSIONS	The data suggests that once-daily IV ( or IV/PO ) moxifloxacin has a comparable efficacy and safety profile to antibiotic regimens approved previously in the subgroup of patients with secondary peritonitis of mild-to-moderate severity .

###25406306
BACKGROUND	International geographic differences in outcomes may exist for clinical trials of heart failure and reduced ejection fraction ( HF-REF ) , but there are few data for those with preserved ejection fraction ( HF-PEF ) .
RESULTS	We analyzed outcomes by international geographic region in the Irbesartan in Heart Failure with Preserved systolic function trial ( I-Preserve ) , the Candesartan in Heart failure Assessment of Reduction in Mortality and morbidity ( CHARM ) - Preserved trial , the CHARM-Alternative and CHARM-Added HF-REF trials , and the Controlled Rosuvastatin Multinational Trial in HF-REF ( CORONA ) .
RESULTS	Crude rates of heart failure hospitalization varied by geographic region , and more so for HF-PEF than for HF-REF .
RESULTS	Rates in patients with HF-PEF were highest in the United States/Canada ( HF hospitalization rate 7.6 per 100 patient-years in I-Preserve ; 8.8 in CHARM-Preserved ) , intermediate in Western Europe ( 4.8 / 100 and 4.7 / 100 ) , and lowest in Eastern Europe/Russia ( 3.3 / 100 and 2.8 / 100 ) .
RESULTS	The difference between the United States/Canada versus Eastern Europe/Russia persisted after adjustment for key prognostic variables : adjusted hazard ratios 1.34 ( 95 % confidence interval , 1.01-1 .74 ; P = 0.04 ) in I-Preserve and 1.85 ( 95 % confidence interval , 1.17-2 .91 ; P = 0.01 ) in CHARM-Preserved .
RESULTS	In HF-REF , rates of HF hospitalization were slightly lower in Western Europe compared with other regions .
RESULTS	For both HF-REF and HF-PEF , there were few regional differences in rates of all-cause or cardiovascular mortality .
CONCLUSIONS	The differences in event rates observed suggest there is international geographic variation in 1 or more of the definition and diagnosis of HF-PEF , the risk profile of patients enrolled , and the threshold for hospitalization , which has implications for the conduct of future global trials .

###24977249
OBJECTIVE	To compare immediately loaded post-extractive single implants using a definitive abutment versus provisional abutment later replaced by custom-made abutment .
METHODS	In two private clinics , 28 patients in need of one single post-extractive implant in the maxilla or mandible from the left second premolar to the right second premolar area were randomised shortly before tooth extraction to provisional abutment ( PA ) and definitive abutment ( DA ) groups .
METHODS	Three patients had to be excluded for buccal wall fracture after tooth extraction .
METHODS	In the PA group , implants were immediately restored using a platform-switched provisional titanium abutment and definitive platform-switched titanium abutments were used in the DA group .
METHODS	In both groups , a non-occluding provisional single crown was provided .
METHODS	Implants were definitively restored after 4 months .
METHODS	In the PA group , the abutment was removed and the impression was made directly on the implant platform .
METHODS	In the DA group an impression of the abutment was made using a retraction cord .
METHODS	Outcome measures were : implant failures ; complications ; and marginal peri-implant bone level changes .
METHODS	Patients were followed up to 1 year after loading .
RESULTS	Twelve patients were randomised to the DA group and 13 patients to the PA group .
RESULTS	At the 12-month follow-up , no implant failed .
RESULTS	One biological complication occurred in the DA group and one mechanical complication occurred in the PA group .
RESULTS	All complications were successfully treated .
RESULTS	One year after loading , implants in the DA group lost an average of 0.11 mm ( SD : 0.06 ) of periimplant bone and implants in PA group about 0.58 mm ( SD : 0.11 ) .
RESULTS	At the 12-month follow-up , there was a statistically significant difference in bone level change between groups ( mean difference : 0.48 mm , CI 95 % 0.40 ; 0.55 , P < 0.0001 ) .
CONCLUSIONS	Within the limits of this study , the non-removal of abutments placed at the time of surgery resulted in the maintenance of 0.5 mm more bone levels around immediately restored postextractive single implants than repeated abutment removal , although this amount of bone maintenance may not have a clinical impact .
CONCLUSIONS	Conflicts of interest notification : Dr Tommaso Grandi and Dr Paolo Guazzi serve as consultants for JDentalCare .
CONCLUSIONS	This study was completely self-financed and no funding was sought or obtained , not even in the form of free materials .

###24583615
OBJECTIVE	To compare clinical profiles of Shang Ring versus conventional circumcisions .
METHODS	Parallel group open-label randomized controlled trial with one-to-one allocations in 2 sites .
METHODS	We enrolled HIV-negative men aged 18-54 years in Homa Bay , Kenya , and Lusaka , Zambia and followed them at 2 , 7 , 14 , 21 , 28 , 42 , and 60 days after Shang Ring versus conventional circumcision .
METHODS	We compared the duration of surgery , postoperative pain using a visual analog scale , adverse events rates , time to complete wound healing by clinical assessment , participant acceptability , and provider preferences between circumcision groups .
RESULTS	We randomized 200 men to each group ; 197 and 201 contributed to the Shang Ring and conventional surgery analyses , respectively .
RESULTS	Adverse event rates were similar between groups .
RESULTS	Pain scores at most time points were similar , however , the Shang Ring group reported higher scores for worst pain during erections ( 3.5 1.9 vs. 2.3 1.7 ; P < 0.001 ) .
RESULTS	Significantly more men were satisfied with the cosmetic appearance following Shang Ring male circumcision ( MC ) , 95.7 % versus 85.9 % ( P = 0.02 ) in Kenya , and 96.8 % versus 71.3 % ( P < 0.01 ) in Zambia .
RESULTS	Although median time to complete wound healing was 43 days in both groups , conventional circumcisions healed on average 5.2 days sooner ( P < 0.001 ) .
RESULTS	Shang Ring procedures took one-third the time of conventional MC , 7 versus 20 minutes .
RESULTS	All circumcision providers preferred the Shang Ring .
CONCLUSIONS	Safety profiles of the 2 techniques were similar , all MC providers preferred the Shang Ring technique , and study participants preferred the Shang Ring 's cosmetic results .
CONCLUSIONS	The Shang Ring should be considered for adult MC as programs scale-up .

###24246459
BACKGROUND	In spite of widespread use of nasal CPAP there are comparatively few studies to guide the choice of nasal prongs .
OBJECTIVE	To determine whether the Fisher & Paykel Healthcare ( FPH ) neonatal continuous positive airway pressure ( CPAP ) interface was effective in providing bubble CPAP when compared to the Hudson prong interface .
METHODS	The study was a randomized cross-over study of twenty newborn infants 500 g or more requiring CPAP for respiratory support at birth .
METHODS	Infants were randomized to either the Fisher & Paykel Healthcare or Hudson CPAP interface for twenty four hours .
METHODS	Crossover between interfaces occurred after subsequent twenty four hour periods .
METHODS	The primary outcome was the provision of desired CPAP pressures , defined as provision of CPAP within one cm H2O of set pressure .
RESULTS	The percentage time CPAP was within one cm H2O of set pressure was 66.5 % for the Hudson and 71.8 % for the FPH interface ( p = 0.66 ) .
RESULTS	Oxygen saturations for the Hudson interface were in target range for a median of 97.8 % of the time , and , with the FPH interface , for a median of 98.2 % of the time ( p = 0.76 ) .
RESULTS	Clinically significant differences in primary or secondary outcomes between the two groups were not detected .
CONCLUSIONS	The nasal CPAP interfaces studied were equally effective in achieving desired bubble CPAP pressures and target saturations .

###25198487
OBJECTIVE	To determine the impact of music intervention on endothelial function , hemodynamics , and patient anxiety before , during , and after cardiac catheterization .
BACKGROUND	The effect of music therapy during cardiac catheterization on endothelial function and patient satisfaction has received limited study .
METHODS	Seventy patients undergoing elective cardiac catheterization were randomized to music therapy ( n = 36 ) or no music therapy ( n = 34 ) .
METHODS	Peripheral arterial tonometry was performed before and after catheterization .
METHODS	A 6 item ( 24-point scale ) questionnaire evaluating patient anxiety and discomfort levels was also administered after the procedure .
RESULTS	Both study groups had similar baseline characteristics , fluoroscopy time , and contrast administration .
RESULTS	Reactive hyperemia index ( RHI ) change was 0.14 0.72 in the music group and 0.30 0.58 in the control group ( P = .35 ) .
RESULTS	Systolic and diastolic blood pressure ( BP ) changes did not significantly differ between the two groups ( systolic BP change -3.3 17.3 mm Hg vs -2.3 19.4 mm Hg ; P = .83 and diastolic BP change -1.9 12.2 mm Hg vs. 2.0 13.4 mm Hg ; P = .23 ) .
RESULTS	Heart rate changes were also comparable between the two groups ( -1 6 beats / min vs -1 7 beats/min ; P = .22 ) .
RESULTS	Patient satisfaction questionnaire measurements were found to be similar in patients with and without music therapy ( 8 [ 7-11 ] vs 9 [ 8-12 ] ; P = .36 ) .
CONCLUSIONS	In this study , music intervention did not elicit a vasodilator response , did not lower blood pressure or heart rate , and did not relieve anxiety or stress discomfort in patients who underwent coronary angiography .

###24962478
BACKGROUND	The perineal wound is a major source of morbidity after abdominoperineal resection ( APR ) for rectal cancer , particularly after preoperative irradiation .
BACKGROUND	Myocutaneous flap reconstruction is a viable alternative to primary perineal wound repair providing well-vascularized non-irradiated tissue to fill the dead space , and improve wound healing .
METHODS	Sixty patients with low rectal cancer receiving neoadjuvant radiotherapy were prospectively randomized to either primary perineal wound closure ( Group B ) or VRAM perineal reconstruction ( Group A ) .
METHODS	The study was carried out in the surgical department , National Cancer Institute ( NCI ) , Cairo University over a period of 4 years from August 2008 to July 2012 .
METHODS	All patients were evaluated as regards incidence of perineal wound complications , abdominal wall complications , and added co-morbidity .
RESULTS	Perineal wound complications were observed in 5 patients in group A ( 17.2 % ) and in 14 patients in group B ( 46.4 % ) ( P = 0.015 ) .
RESULTS	There was no significant difference in the incidence of abdominal wound morbidity between both groups .
RESULTS	Operative blood loss and time were lower in group B.
CONCLUSIONS	The vertical rectus myocutaneous flap ( VRAM ) is a relatively simple and reliable technique for perineal wound reconstruction after abdominoperineal resection .

###25266426
BACKGROUND	Quantifying pediatric immunologic recovery by highly active antiretroviral therapy ( HAART ) initiation at different CD4 percentage ( CD4 % ) and age thresholds may inform decisions about timing of treatment initiation .
METHODS	HIV-1-infected , HAART-naive children in Europe and the Americas were followed from 2002 through 2009 in PENPACT-1 .
METHODS	Data from 162 vertically infected children , with at least World Health Organization `` mild '' immunosuppression and CD4 % < 10th percentile , were analyzed for improvement to a normal CD4 % ( 10th percentile ) within 4 years after HAART initiation .
METHODS	Data from 209 vertically infected children , regardless of immune status , were analyzed for CD4 % outcomes at 4 years and viral failure within 4 years .
RESULTS	Seventy-two percent of baseline immunosuppressed children recovered to normal within 4 years .
RESULTS	Compared with `` severe '' immunosuppression , more children with `` mild '' immunosuppression ( difference 36 % , 95 % confidence interval [ CI ] : 22 % to 49 % ) or `` advanced '' immunosuppression ( difference 20.8 % , 95 % CI : 5.8 % to 35.9 % ) recovered a normal CD4 % .
RESULTS	For each 5-year increase in baseline age , the proportion of children achieving a normal CD4 % declined by 19 % ( 95 % CI : 11 % to 27 % ) .
RESULTS	Combining baseline CD4 % and age effects resulted in > 90 % recovery when initiating HAART with `` mild '' immunosuppression at any age or `` advanced '' immunosuppression at age < 3 years .
RESULTS	Baseline CD4 % effects became greater with increasing age ( P = .02 ) .
RESULTS	At 4 years , most immunologic benefits were still significant but diminished .
RESULTS	Viral failure was highest in infancy ( 56 % ) and adolescence ( 63 % ) .
CONCLUSIONS	Initiating HAART at higher CD4 % and younger ages maximizes potential for immunologic recovery .
CONCLUSIONS	Guidelines should weigh immunologic benefits against long-term risks .

###25291749
OBJECTIVE	To evaluate and compare the visual , refractive , contrast sensitivity , and aberrometric outcomes with a diffractive bifocal and trifocal intraocular lens ( IOL ) of the same material and haptic design .
METHODS	Sixty eyes of 30 patients undergoing bilateral cataract surgery were enrolled and randomly assigned to one of two groups : the bifocal group , including 30 eyes implanted with the bifocal diffractive IOL AT LISA 801 ( Carl Zeiss Meditec , Jena , Germany ) , and the trifocal group , including eyes implanted with the trifocal diffractive IOL AT LISA tri 839 MP ( Carl Zeiss Meditec ) .
METHODS	Analysis of visual and refractive outcomes , contrast sensitivity , ocular aberrations ( OPD-Scan III ; Nidek , Inc. , Gagamori , Japan ) , and defocus curve were performed during a 3-month follow-up period .
RESULTS	No statistically significant differences between groups were found in 3-month postoperative uncorrected and corrected distance visual acuity ( P .21 ) .
RESULTS	However , uncorrected , corrected , and distance-corrected near and intermediate visual acuities were significantly better in the trifocal group ( P < .01 ) .
RESULTS	No significant differences between groups were found in postoperative spherical equivalent ( P = .22 ) .
RESULTS	In the binocular defocus curve , the visual acuity was significantly better for defocus of -0.50 to -1.50 diopters in the trifocal group ( P .04 ) and -3.50 to -4.00 diopters in the bifocal group ( P .03 ) .
RESULTS	No statistically significant differences were found between groups in most of the postoperative corneal , internal , and ocular aberrations ( P .31 ) , and in contrast sensitivity for most frequencies analyzed ( P .15 ) .
CONCLUSIONS	Trifocal diffractive IOLs provide significantly better intermediate vision over bifocal IOLs , with equivalent postoperative levels of visual and ocular optical quality .

###24864045
BACKGROUND	Higher heart rate is associated with poorer outcomes in patients with heart failure and reduced ejection fraction ( HF-REF ) .
BACKGROUND	Less is known about the association between heart rate and outcomes in patients with heart failure and preserved ejection fraction ( HF-PEF ) .
BACKGROUND	Therefore , we examined the relationship between heart rate and outcomes in the irbesartan in patients with heart failure and preserved systolic function trial ( I-Preserve ) in patients with an ejection fraction > 45 % aged > 60 years .
RESULTS	Heart rate was analysed as both a categorical ( tertiles ) and continuous variable .
RESULTS	Patients in sinus rhythm ( n = 3271 ) and atrial fibrillation ( n = 696 ) were analysed separately .
RESULTS	The outcomes examined were the primary endpoint of the trial ( all-cause death or cardiovascular hospitalization ) , the composite of cardiovascular death or heart failure hospitalization ( and its components ) and all-cause death alone .
RESULTS	Higher heart rate was associated with a significantly higher risk of all outcomes studied for patients in sinus rhythm , even after adjustment for other prognostic variables , including N-terminal pro-B-type natriuretic peptide .
RESULTS	Each standard deviation ( 12.4 bpm ) increase in heart rate was associated with an increase in risk of 13 % for cardiovascular death or heart failure hospitalization ( P = 0.002 ) .
RESULTS	No relationship between heart rate and outcomes was observed for patients in atrial fibrillation .
RESULTS	Beta-blocker treatment did not reduce the heart rate-risk relationship .
CONCLUSIONS	In patients with heart failure and preserved ejection fraction , heart rate is in sinus rhythm an independent predictor of adverse clinical outcomes and might be a therapeutic target in this syndrome .
CONCLUSIONS	Clinical Trial Registration - URL http://www.clinicaltrials.gov .
CONCLUSIONS	Unique identifier : NCT 0095238 .

###25219129
OBJECTIVE	To observe the effect of warm-reinforcing needling combined with modern rehabilitation training on motor function of cerebral palsy ( CP ) children .
METHODS	Sixty cases of CP children were randomly divided into acupuncture combined with rehabilitation ( Acu + Rehab , n = 30 ) group and Rehab ( n = 30 ) group .
METHODS	Patients of the Acu + Rehab group were treated by warm-reinforcing needling stimulation of Jiaji ( EX-B 2 ) , Jianyu ( LI 15 ) , Quchi ( LI 11 ) , Hegu ( LI 4 ) , Zusanli ( ST 36 ) , Yinlingquan ( GB 34 ) , Sanyinjiao ( SP 6 ) , Juegu ( GB 39 ) , Yanglingquan ( GB 34 ) , etc. , combined with Bobath rehabilitation therapy , and those of the Rehab group treated by Bobath rehabilitation ( stimulating key control points in the body , triggering reflexes that provide head and body control ) .
METHODS	The treatment was conducted every day , with three months being a therapeutic course , two courses in all .
METHODS	The Peabody Developmental Motor Scales 2 ( PDMS-2 ) was used to evaluate the CP children 's motor function [ 1 ) gross motor : posture ( straightness ratio ) , locomotion and object manipulation ; 2 ) fine motor : grasping and visual-Motor integration ] .
RESULTS	After the treatment , of the 30 and 30 cases in the Acu + Rehab and Rehab groups , 1 ( 3.33 % ) and 0 ( 0 % ) were cured , 20 ( 66.67 % ) and 18 ( 60.00 % ) experienced marked improvement , 9 ( 30.00 % ) and 12 ( 40.00 % ) were invalid , with the effective rates being 70.00 % and 60.00 % respectively .
RESULTS	The therapeutic effect of the Acu + Rehab group was markedly superior to that of the Rehab group ( P < 0.05 ) .
RESULTS	After 6 months ' treatment , the scores of posture , locomotor , object manipulation and grasping , and visual-movement integration were significantly increased in comparison with pre-treatment in the same one group ( P < 0.05 ) , and the effects of the Acu + Rehab group were obviously superior to those of Rehab group in increasing the scores of posture , locomotor , object manipulation and grasping after 6 months ' treatment ( P < 0.05 ) .
CONCLUSIONS	Warm-reinforcing needling combined with Bobath rehabilitation has a better therapeutic effect in improving gross motor and fine motor functions of CP children .

###25634646
METHODS	Data were obtained through a multisite clinical trial in which different types of genetic risk-related information were disclosed to individuals ( n = 246 ) seeking a risk assessment for Alzheimer 's disease .
RESULTS	Six weeks after disclosure , 83 % of participants correctly recalled the number of risk-increasing APOE alleles they possessed , and 74 % correctly recalled their APOE genotype .
RESULTS	While 84 % of participants recalled their lifetime risk estimate to within 5 percentage points , only 51 % correctly recalled their lifetime risk estimate exactly .
RESULTS	Correct recall of the number of APOE risk-increasing alleles was independently associated with higher education ( p < 0.001 ) , greater numeracy ( p < 0.05 ) and stronger family history of Alzheimer 's disease ( p < 0.05 ) .
RESULTS	Before adjustments for confounding , correct recall of APOE genotype was also associated with higher education , greater numeracy and stronger family history of Alzheimer 's disease , as well as with higher comfort with numbers and European American ethnicity ( all p < 0.05 ) .
RESULTS	Correct recall of the lifetime risk estimate was independently associated only with younger age ( p < 0.05 ) .
CONCLUSIONS	Recall of genotype-specific information is high , but recall of exact risk estimates is lower .
CONCLUSIONS	Incorrect recall of numeric risk may lead to distortions in understanding risk .
CONCLUSIONS	Further research is needed to determine how best to communicate different types of genetic risk information to patients , particularly to those with lower educational levels and lower numeracy .
CONCLUSIONS	Health-care professionals should be aware that each type of genetic risk information may be differentially interpreted and retained by patients and that some patient subgroups may have more problems with recall than others .

###26152132
OBJECTIVE	Selexipag is a novel , oral , selective prostacyclin ( PGI2 ) receptor agonist in clinical development for the treatment of pulmonary arterial hypertension .
OBJECTIVE	Film-coated tablets with strength between 200 and 1,600 g were used .
OBJECTIVE	Bioequivalence between 8 x 200 g and a new 1,600 g tablet was evaluated at steady state in healthy male subjects .
METHODS	This was an open-label , 2-treatment , 2-period , crossover , up-titration , phase 1 study .
METHODS	The treatments were selexipag at 1,600 g b.i.d. for 4.5 days either as 8 x 200 g tablets ( reference : A ) or 1 x 1,600 g tablet ( test : B ) , both preceded by an up-titration phase starting from 400 g b.i.d. doses , in 200-g steps every 4th day .
METHODS	Subjects were randomized 1 : 1 to the A-B or B-A sequence .
METHODS	The pharmacokinetics and tolerability of selexipag and its active metabolite , ACT-333679 , were investigated .
RESULTS	80 subjects were enrolled in the study : 65 subjects completed the study according to protocol , and 15 subjects withdrew from the study .
RESULTS	The most frequent adverse events ( AEs ) were headache ( 86 % ) , myalgia ( 73 % ) , and jaw pain ( 73 % ) .
RESULTS	There was no difference in nature and overall frequency of AEs between the two treatments .
RESULTS	Steady state was attained within 3 days of the selexipag 1,600 g b.i.d.
METHODS	The 90 % confidence intervals ( CIs ) of the geometric mean ratio ( B/A ) at steady state for AUC and Cmax , ss were within ( 0.80 , 1.25 ) bioequivalence interval : ( 0.92 , 1.06 ) and ( 0.95 , 1.14 ) , respectively , for selexipag and ( 0.95 , 1.06 ) and ( 0.94 , 1.07 ) , respectively , for the active metabolite , ACT-333679 .
CONCLUSIONS	Bioequivalence was demonstrated between 8 x 200 g and 1 x 1,600 g selexipag at steady state .

###24809878
BACKGROUND	The PASI score , the most common outcome measure in clinical trials of psoriasis treatment , is a non-linear scale that does not allow reliable assessment of subtle variations of its components ( erythema , induration , and desquamation ) .
OBJECTIVE	Highlight treatment response patterns potentially hidden by PASI score 's compounded weighted-average calculation .
METHODS	Patients with moderate-to-severe psoriasis enrolled in the phase-3 , 16-week , randomized CHAMPION study , and received adalimumab , methotrexate , or placebo .
METHODS	PASI scores were assessed post hoc for improvement , by body region and component .
RESULTS	At Week 16 , a significantly greater percentage of adalimumab-treated patients vs methotrexate - and placebo-treated patients , achieved PASI 75 , PASI 90 and PASI 100 response in each body region and component .
RESULTS	55.7 % of adalimumab-treated patients reached PASI 100 response in the head and neck region vs 16.7 % overall .
RESULTS	Two key components of PASI , induration and desquamation , were affected by treatment more than erythema , the third component .
RESULTS	Adalimumab was particularly effective in complete resolution of induration ( 44.9 % of patients ) vs methotrexate ( 10.9 % ) .
RESULTS	For all PASI body regions and components , mean percent improvement in score at Weeks 2 , 4 , 8 , 12 , and 16 was significantly greater ( P < 0.05 ) for adalimumab treatment vs methotrexate or placebo .
CONCLUSIONS	Adalimumab therapy resulted in complete resolution of individual body regions in at least 30.6 % up to 55.7 % of patients in CHAMPION .
CONCLUSIONS	This was more than twice that of methotrexate and placebo .
CONCLUSIONS	PASI improvement by body region is a novel and an important patient-relevant outcome worthy of reporting in future studies .

###24789677
OBJECTIVE	Progression of Parkinson 's disease ( PD ) is frequently characterized by the occurrence of freezing of gait ( FOG ) representing a disabling motor complication .
OBJECTIVE	We aim to investigate safety and efficacy of transcranial direct current stimulation of the primary motor cortex of PD patients with FOG .
METHODS	In this cross-over , double-blind , sham-controlled study , 10 PD patients with FOG persisting in `` on '' state underwent anodal and sham direct current stimulation for 5 consecutive days .
METHODS	Clinical assessment over a 1-month period was performed .
RESULTS	A significant improvement of gait , as assessed by the Stand Walk Sit test , with reduction in number and duration of FOG episodes , along with a significant reduction in the Unified Parkinson 's Disease Rating Scale score , were observed after anodal stimulation .
RESULTS	Beneficial effects were more evident after the entire 5-day stimulation session , and persisted until the end of the observation period .
CONCLUSIONS	Anodal transcranial direct current stimulation of the motor cortex is safe and has therapeutic potential in PD patients with FOG .

###24319096
BACKGROUND	Many patients who are candidates for implantable cardioverter defibrillators ( ICDs ) are not referred for potential implantation .
BACKGROUND	We sought to determine if a simple provider reminder would increase referrals .
RESULTS	We identified consecutive patients from January 2007 through July 2010 in the VA Palo Alto Health Care System with a left ventricular ejection fraction < 35 % on echocardiography .
RESULTS	Patients were excluded using available administrative data only ( no chart review ) if they were known to have an ICD , if they were 80 years old , or if they did not have a current primary care or cardiology provider within the system .
RESULTS	We randomized patients to no intervention or a clinical note to the provider in the medical record .
RESULTS	The outcomes were referral for consideration of defibrillator implantation ( primary ) and documented discussion ( secondary ) .
RESULTS	Of 330 patients with left ventricular ejection fraction35 % , 128 were known to have an ICD , 85 were no longer followed in the healthcare system , and 28 were 80 years old , leaving 89 patients to be randomized .
RESULTS	Forty-six patients were randomized to intervention and 43 to control .
RESULTS	Eleven of 46 ( 24 % ) intervention patients were referred for consideration of ICD implantation during the following 6 months versus 1 of 43 ( 2 % ) control patients ( P = 0.004 ) .
RESULTS	Overall , 31 of 46 ( 67 % ) intervention patients versus 19 of 43 ( 44 % ) control patients had documentation discussing potential candidacy for defibrillators ( P = 0.05 ) .
CONCLUSIONS	In patients with low left ventricular ejection fraction , a simple electronic medical record-based intervention directed to their providers improved the rates of referral for ICD implantation .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01217827 .

###25440110
OBJECTIVE	The existing research findings regarding the effects of lemongrass ( Cymbopogon citratus ) tea on renal function indices are conflicting and inconclusive .
OBJECTIVE	In the present study , we investigated the effects of infusions prepared from C citratus leaves on creatinine clearance rate ( CCr ) and estimated glomerular filtration rate ( eGFR ) in humans .
METHODS	One hundred five subjects ( 55 men and 50 women ) aged 18 to 35years were randomly assigned to groups set to orally receive infusions prepared from 2 , 4 , or 8g of C citratus leaf powder once daily , for 30days .
METHODS	Serum and urinary levels of urea , creatinine , pH , specific gravity , uric acid , electrolytes , diuretic indices , and eGFR were assessed at days 0 , 10 , and 30 after the initiation of treatment .
METHODS	Results obtained on days10 and 30 were compared with baseline values .
RESULTS	CCr and eGFR decreased significantly at day 30 in both male and female subjects in all the groups and in females treated with infusion prepared from 8g of C citratus leaf powder for 10days .
RESULTS	At day 10 , CCr and eGFR were unchanged in those treated with infusions prepared from 2 or 4g of the leaf powder , whereas diuretic indices ( urine volume , urination frequency , diuretic action , and saliuretic indices ) increased above the baseline levels .
RESULTS	Serum and urinary creatinine levels significantly increased ( P < .05 ) in both male and female subjects in all the groups .
RESULTS	Serum urea significantly increased in the groups treated with infusions prepared from 4 or 8g of the leaf powder ( P < .05 ) for 30days .
RESULTS	Serum electrolytes remained unchanged , but their urinary levels increased .
CONCLUSIONS	We observed dose - and time-dependent adverse effects of C citratus on CCr and eGFR .
CONCLUSIONS	At a high dose or with prolonged treatment with a low dose , eGFR decrease may be followed by a decline in the other renal function indices .

###24326361
OBJECTIVE	Treatment of complex fractures of the distal femur utilizing monoaxial locking plates ( e.g. Less Invasive Stabilisation System , LISS , Synthes ) is considered to be superior to conventional plating systems .
OBJECTIVE	Due to the limitation that the thread forces the screw into pre-determined positions , modifications have been made to allow screw positioning within a range of 30 ( Non Contact Bridging , NCB-DF , Zimmer ) .
OBJECTIVE	For the first time , this multicenter prospective randomized clinical trial ( RCT ) investigates the outcome of LISS vs. NCB-DF treatment following complex fractures of the distal femur .
METHODS	Since June 2008 , 27 patients with a fracture of the distal femur ( AO ASIF 33-A-C and periprosthetic fractures ) were enrolled in this study by four university trauma centres in southern Germany .
METHODS	Clinical ( e.g. range of motion , Oxford knee score , Tegner score ) and radiological ( e.g. axis deviation , secondary loss of realignment ) follow-ups were conducted one and six weeks , as well as three , six , and 12 months after the operation .
RESULTS	This study comprises data of 27 patients ( 8 male , 19 female ; 15 NCB-DF , 12 LISS ) .
RESULTS	Polyaxial osteosynthesis using the NCB system tended to result in better functional knee scores and a higher range of motion .
RESULTS	Interestingly , fracture union tended to be more rapid using the polyaxial plating system .
CONCLUSIONS	We present the analysis of a multicenter prospective RCT to compare the monoaxial LISS vs. the polyaxial NCB-DF treatment following complex fractures of the distal femur .
CONCLUSIONS	NCB-DF treatment tended to result in better functional and radiological outcomes than LISS treatment .
METHODS	Level I.

###25500489
BACKGROUND	Hemodynamic stability is one of the most critical concerns during induction of anesthesia .
BACKGROUND	Whether the pharmacokinetic model by Marsh or the one by Schnider will produce better hemodynamic stability remains unclear .
BACKGROUND	This study compared hemodynamic changes during induction between the two models .
METHODS	60 patients who underwent elective surgery were randomly assigned to plasma target-controlled infusion by Marsh 's ( n = 30 ) or Schnider 's ( n = 30 ) model with an initial target concentration of 4 gmL-1 .
METHODS	The target was then reset and gradually titrated to a sedation level with a narcotrend index ( NI ) below 64 .
METHODS	Stroke volume , cardiac output , systemic vascular resistance , arterial pressure , target , and effect site concentration , and dose of propofol infused were recorded every minute during the first 25 minutes of infusion .
RESULTS	Throughout the first 25 minutes , stroke volume index and cardiac index were decreased significantly in both Marsh and Schnider groups , but no statistical difference was detected between the groups ( p > 0.05 ) .
RESULTS	Central venous pressure ( CVP ) , systemic vascular resistance index ( SVRI ) , and heart rate ( HR ) did not significantly change during induction ( p > 0.05 ) .
RESULTS	Time to loss of responsiveness ( LOR ) , and time for NI to decrease to 64 was faster in Marsh than in Schnider ( 1.51 0.8 minutes vs. 2.8 1.2 min , p < 0.001 ; 3.3 2.0 minutes vs. 5.2 2.3 minutes , p < 0.01 , respectively ) .
CONCLUSIONS	When target concentrations are titrated according to NI during induction of anesthesia , Marsh 's model could induce sedation faster than Schnider 's .
CONCLUSIONS	Meanwhile , hemodynamic changes were not observed to be statistically different between the two models .
CONCLUSIONS	Hypotension induced by plasma target-controlled infusion of propofol could mainly be attributed to decreased stroke volume instead of vascular dilation .

###24930177
OBJECTIVE	The effects of box shape -- specifically width and height -- on the perception of heaviness were evaluated during individual and team lifting .
BACKGROUND	Large objects are perceived to be as much as 50 % lighter than smaller objects with the same mass .
BACKGROUND	This size-weight illusion presents an obvious risk when lifting large and heavy boxes .
BACKGROUND	Recent research has shown that shape influences this illusion .
BACKGROUND	Specifically , increases in length and width do not produce identical decreases in perceived heaviness .
BACKGROUND	However , this effect has been documented only in individual lifting , mostly with small objects .
METHODS	Individuals and teams lifted large boxes and reported their perceptions of heaviness .
METHODS	The mass , height , and width of the boxes were varied independently to determine their unique effects on perceived heaviness .
RESULTS	For both types of lift , increasing width produced a greater mean illusory drop ( expressed as a percentage decrease with 95 % confidence intervals ) in perceived heaviness ( 24 + / - 7 % during individual lifting and 41 + / - 8 % during team lifting ) than increasing height ( 15 + / - 7 % during individual lifting and 18 + / - 8 % during team lifting ) .
CONCLUSIONS	Size and shape are important factors in perceiving the heaviness of boxes during both individual and team lifting .
CONCLUSIONS	To avoid misperceiving weight and risking injury , lifters should be careful when approaching larger ( especially wider ) boxes .

###25637076
OBJECTIVE	Primary hyperparathyroidism ( PHPT ) is diagnosed by the presence of hypercalcemia and elevated or nonsuppressed parathyroid hormone ( PTH ) levels .
OBJECTIVE	Although surgery is usually curative , some individuals fail or are unable or unwilling to undergo parathyroidectomy .
OBJECTIVE	In such individuals , targeted medical therapy may be of value .
OBJECTIVE	Cinacalcet normalized calcium level and lowered PTH in patients with PHPT in several phase 2 and open-label studies .
OBJECTIVE	We compared cinacalcet and placebo in subjects with PHPT unable to undergo parathyroidectomy .
METHODS	Phase 3 , double-blind , multi centere , randomized , placebo-controlled study .
METHODS	Sixty-seven subjects ( 78 % women ) with moderate PHPT were randomized ( 1:1 ) to cinacalcet or placebo for 28 weeks .
METHODS	Achievement of a normal mean corrected total serum calcium concentration of 10.3 mg/dl ( 2.575 mmol/l ) .
RESULTS	Baseline median ( quartile 1 ( Q1 ) , Q3 ) serum PTH was 164.0 ( 131.0 , 211.0 ) pg/ml and mean ( s.d. ) serum Ca was 11.77 ( 0.46 ) mg/dl .
RESULTS	Serum Ca normalized ( 10.3 mg/dl ) in 75.8 % of cinacalcet - vs 0 % of placebo-treated subjects ( P < 0.001 ) .
RESULTS	Corrected serum Ca decreased by 1.0 mg/dl from baseline in 84.8 % of cinacalcet - vs 5.9 % of placebo-treated subjects ( P < 0.001 ) .
RESULTS	Least squares mean ( s.e.m. ) plasma PTH change from baseline was -23.80 % ( 4.18 % ) ( cinacalcet ) vs -1.01 % ( 4.05 % ) ( placebo ) ( P < 0.001 ) .
RESULTS	Similar numbers of subjects in the cinacalcet and placebo groups reported adverse events ( AEs ) ( 27 vs 20 ) and serious AEs ( three vs four ) .
RESULTS	Most commonly reported AEs were nausea and muscle spasms .
CONCLUSIONS	These results demonstrate that cinacalcet normalizes serum calcium in this PHPT population and appears to be well tolerated .

###24347519
BACKGROUND	This randomized phase III trial compared pathologic complete response ( pCR ) rates of early breast cancer ( EBC ) following neoadjuvant epirubicin-docetaxel ( ED ) capecitabine ( C ) , and evaluated the addition of trastuzumab in HER2-positive tumors .
METHODS	Patients with invasive breast cancer ( except T4d ) were randomly assigned to receive six 3-weekly cycles of ED ( both 75 mg/m2 ) C ( 1000 mg/m2 , twice daily , days 1-14 ) .
METHODS	Patients with HER2-positive disease were further randomized to receive trastuzumab ( 8 mg/kg , then 6 mg/kg every 3 weeks ) or not .
METHODS	Primary end point : pCR rate at the time of surgery .
RESULTS	Five hundred thirty-six patients were randomized to ED ( n = 266 ) or EDC ( n = 270 ) ; 93 patients were further randomized to trastuzumab ( n = 44 ) or not ( n = 49 ) .
RESULTS	pCR rate was significantly increased with EDC ( 23.0 % versus 15.4 % ED , P = 0.027 ) , and nonsignificantly further increased with trastuzumab ( 38.6 % EDC versus 26.5 % ED , P = 0.212 ) .
RESULTS	Rates of axillary node involvement at surgery and breast conservation were improved with EDC versus ED , but not significantly ; the addition of trastuzumab had no further impact .
RESULTS	Hormone receptor status , tumor size , grade , and C ( all P0 .035 ) were independent prognostic factors for pCR .
RESULTS	Trastuzumab added to EDC significantly increased the number of serious adverse events ( 35 versus 18 ; P = 0.020 ) , mainly due to infusion-related reactions .
CONCLUSIONS	These findings show that the integration of C into a neoadjuvant taxane - / anthracycline-based regimen is a feasible , safe , and effective treatment option , with incorporation of trastuzumab in HER2-positive disease .
BACKGROUND	NCT00309556 , www.clinicaltrials.gov .

###24684771
OBJECTIVE	This study explored the safety and efficacy of recombinant type I pancreatic elastase ( PRT-201 ) topically applied once to the external surface of an arteriovenous fistula .
METHODS	This was a randomized , double-blind , placebo-controlled trial .
METHODS	Adults with kidney disease undergoing creation of a radiocephalic fistula ( RCF ) or brachiocephalic fistula were randomized to treatment with placebo ( n = 51 ) , PRT-201 at 10 g ( n = 51 ) , or PRT-201 at 30 g ( n = 49 ) .
METHODS	The primary efficacy measure was unassisted primary patency ( PP ) over 1 year .
METHODS	Secondary efficacy measures were secondary patency ( SP ) , unassisted maturation by ultrasound interrogation , use for hemodialysis , and hemodynamically significant lumen stenosis .
RESULTS	Median PP was 224 days for placebo and > 365 days for the PRT-201 groups .
RESULTS	At 1 year , 45 % , 54 % , and 53 % of placebo , 10-g , and 30-g patients retained PP .
RESULTS	The risk of PP loss was nonsignificantly reduced for 10 g ( hazard ratio [ HR ] , 0.69 ; P = .19 ) and 30 g ( HR , 0.67 ; P = .17 ) vs placebo .
RESULTS	In the subset ( 44 % of patients ) with a RCF , the median PP was 125 days for placebo and > 365 days for the PRT-201 groups .
RESULTS	At 1 year , 31 % , 50 % , and 63 % of placebo , 10-g , and 30-g RCFs retained PP .
RESULTS	The risk of RCF PP loss was nonsignificantly reduced by 10 g ( HR , 0.59 ; P = .18 ) and significantly reduced by 30 g ( HR , 0.37 ; P = .02 ) vs placebo .
RESULTS	At 1 year , 77 % , 81 % , and 83 % of placebo , 10-g , and 30-g patients retained SP .
RESULTS	The risk of SP loss was nonsignificantly reduced for 10 g ( HR , 0.79 ; P = .61 ) and 30 g ( HR , 0.76 ; P = .55 ) vs placebo .
RESULTS	In the subset with RCFs , 65 % , 82 % , and 90 % of placebo , 10-g , and 30-g patients retained SP at 1 year .
RESULTS	The risk of RCF SP loss was nonsignificantly reduced for 10 g ( HR , 0.45 ; P = .19 ) and 30 g ( HR , 0.27 ; P = .08 ) vs placebo .
RESULTS	At month 3 , 67 % , 87 % ( P = .03 ) , and 92 % ( P < .01 ) of the placebo , 10-g , and 30-g group fistulas had unassisted maturation by ultrasound interrogation .
RESULTS	At month 3 in the subset with an RCF , 47 % , 74 % ( P = .17 ) , and 93 % ( P < .01 ) of placebo , 10-g , and 30-g group fistulas had unassisted maturation by ultrasound interrogation .
RESULTS	Adverse event reports were not meaningfully different between groups .
CONCLUSIONS	PRT-201 appeared safe .
CONCLUSIONS	The primary efficacy end point was not met .
CONCLUSIONS	However , both PRT-201 doses were associated with improved unassisted maturation .
CONCLUSIONS	The 30-g dose was associated with increased PP in the subset with RCF .

###25515553
BACKGROUND	Ingestion of polyunsaturated fatty acids ( PUFAs ) has been proposed to influence several chronic diseases including coronary heart disease ( CHD ) and type-2 diabetes ( T2D ) .
BACKGROUND	There is strong evidence that omega-3 ( n-3 ) PUFAs provide protection against CHD and biomarkers of atherosclerosis .
BACKGROUND	In contrast , there is more limited and inconsistent data for T2D .
BACKGROUND	Few studies have examined the impact of n-3 PUFA-containing botanical oils on T2D .
METHODS	Fifty-nine subjects with early-stageT2D or metabolic syndrome participated in an 8-week , randomized , single-blind , parallel intervention study and were provided PUFA-containing oils .
METHODS	Individuals received either corn oil ( CO ) , a botanical oil ( BO ) combination ( borage [ Borago officinalis L. ] / echium oil [ Echium plantagineum L. ] ) or fish oil ( FO ) .
METHODS	The BO combination was enriched in alpha-linolenic , gamma-linolenic , and stearidonic acids and the FO in eicosapentaenoic and docosahexaenoic acids .
METHODS	Serum fatty acids and other serum lipids ( triglycerides and total , HDL and LDL cholesterol ) , as well as markers of inflammation ( leptin , and C-reactive protein ) and glucose regulation ( glucose and hemoglobin A1c ) were assessed from fasting participants at baseline and after the intervention .
RESULTS	Compliance was verified by expected increases in specific PUFAs in each of the three oil arms .
RESULTS	Participants in the CO group showed no differences in serum lipids , markers of inflammation or glucose regulation between pre - and post-treatment measures .
RESULTS	Supplementation with BO significantly lowered total and LDL cholesterol levels and FO reduced serum triglycerides , hemoglobin A1c and increased HDL-cholesterol .
CONCLUSIONS	Short-term dietary supplementation with BO and FO improved biomarkers associated with T2D/metabolic syndrome .
BACKGROUND	Clinicaltrial.gov NCT01145066 .

###25281492
OBJECTIVE	The role of secondary cytoreductive surgery ( SCR ) in platinum-sensitive recurrent ovarian cancer ( ROC ) remains controversial .
OBJECTIVE	The overall survival ( OS ) benefits for surgery reported in observational studies may be due to the selection of patients with better prognosis .
METHODS	Using data from the CALYPSO trial , OS of patients who had SCR was compared to those treated with chemotherapy alone .
METHODS	Multivariate analyses were performed to adjust for prognostic factors .
METHODS	We also tested for an interaction between baseline prognostic groupings and the benefit of surgery .
RESULTS	Of the 975 patients randomised in CALYPSO , 19 % had SCR and 80 % had chemotherapy alone .
RESULTS	OS was longer for the SCR group than for chemotherapy alone ( median , 49.9 vs. 29.7 months ; adjusted hazard ratio ( HR ) , 0.68 ; P = 0.004 ) .
RESULTS	For patients with SCR , the 3-year OS was 72 % for those with no measurable disease , and 28 % if residual tumour was larger than 5 cm .
RESULTS	Patients with good prognostic features benefited the most from SCR ( HR 0.43 ; P < 0.001 ) .
RESULTS	The benefit of SCR was less in patients with poorer prognostic features ( test of trend P < 0.001 ) .
CONCLUSIONS	SCR was associated with improved OS in platinum-sensitive ROC , particularly in patients with favourable prognostic characteristics .
CONCLUSIONS	However , these findings may be due to selection bias , and hence randomised trials are still essential .

###24793931
OBJECTIVE	To evaluate the verbal and written preoperative information in patients undergoing surgery for malignant gynaecologic disease , in terms of satisfaction about preoperative received informations , hospitalization days , postoperative pain experienced using visual analogue scale ( VAS ) and number of pain drugs used daily .
METHODS	From January 2008 to December 2012 , consecutive patients with diagnosis of endometrial cancer , referred to the Division of Gynecology of University Campus Bio-Medico of Rome , were enrolled .
METHODS	Eligible subjects were randomized into two groups : Group V ( Verbal information ward ) consisted of patients who had verbal preoperative information about surgical procedure and postoperative management and Group W ( Written Information ward ) consisted of patients who had written preoperative information .
METHODS	All preoperative and postoperative data were recorded .
METHODS	Concerning satisfaction about preoperative received informations , patients were asked to complete the QLQ-C30 and the EORTC INFO25 .
RESULTS	190 patients were considered in this study .
RESULTS	Group W ( n = 92 ) has a better info satisfaction ( p = 0.0008 , statistically significant ) , a mean VAS value lower ( p = 0.02 , statistically significant ) and also a lower number of hospitalization days ( p = 0.0265 , statistically significant ) and pain medications used daily , ( p = 0.0120 , statistically significant ) , comparing with group V ( n = 98 ) .
CONCLUSIONS	We support the use of preoperative information leaflet to better prepare patients for a surgical procedure , showing a faster recovery , low medications use and a better quality of life outcome .

###24362611
BACKGROUND	In most Asian countries , 50 - 90 % of pharmaceutical sales are made in private drug outlets , by personnel with some training in drugs but not for the treatment of common health problems .
BACKGROUND	The objective of the study was to determine effects of focused training for private drug sellers to improve practices in treating acute respiratory infections and diarrhoea in children , and anaemia in pregnancy in Nepal .
METHODS	Randomized controlled , four way nested design study incorporating four interventions for drug retailers in both hill and terai districts .
METHODS	One group received mailed printed educational materials followed by mailed feedback ; a second received small group training followed by feedback ; a third received small group training only ; and a fourth , the control group , received no intervention .
METHODS	Surrogate customer method was used to assess practices .
METHODS	Outcomes were measured using multivariate linear regression .
RESULTS	A significant increase in the asking of key history questions , recommendation ( prescribing by drug retailers ) of cotrimoxazole , and advice-giving for pneumonia ; a significant increase in ORS recommendation , and advice giving for diarrhoea including the avoidance of antidiarrhoeals ; and a significant increase in asking key history questions and recommending appropriate products in pregnancy cases .
CONCLUSIONS	Training intervention as well as training followed by practice feedback was effective in improving the management of common illnesses and pregnancy by private drug sellers .

###25198268
OBJECTIVE	A post hoc analysis to determine the diagnostic yield of random biopsy in detecting high-grade cervical disease in women with negative colposcopy .
METHODS	The ATHENA ( Addressing the Need for Advanced HPV Diagnostics ) trial screened more than 47,000 women with cytology and high-risk human papillomavirus ( HPV ) DNA genotyping .
METHODS	Colposcopy was performed in all women with abnormal cytology or positive HPV results .
METHODS	A single random biopsy was taken at the squamocolumnar junction if colposcopy was adequate and no lesions were identified .
RESULTS	The random biopsy diagnosed 20.9 % ( 81/388 , 95 % confidence interval [ CI ] 16.9-25 .3 % ) and 18.9 % ( 45/238 , 95 % CI 14.1-24 .5 % ) of the total cervical intraepithelial neoplasia ( CIN ) grade 2 or worse and grade 3 or worse , respectively .
RESULTS	This additional disease was detected in both HPV 16 or 18 + and for 12 other high-risk HPV + women .
RESULTS	For HPV 16 or 18 , the absolute risk for detection of CIN 2 or worse on random biopsy in the overall population was 13.1 % ( 40/305 , 95 % CI 9.8-17 .4 % ) and 8.2 % ( 25/305 , 95 % CI 5.6-11 .8 % ) for CIN 3 or worse .
RESULTS	By contrast , the absolute risk for 12 other high-risk HPV + women was 3.5 % ( 29/820 , 95 % CI 2.5-5 % ) and 1.7 % ( 14/820 , 95 % CI 1.0-2 .8 % ) for CIN 2 or worse and CIN 3 or worse , respectively .
CONCLUSIONS	A single random biopsy increased the detection of high-grade disease when no lesions were visualized at colposcopy .
CONCLUSIONS	The absolute risks of disease associated with the random biopsy were highest for women positive for genotype 16 or 18 .
CONCLUSIONS	Our study supports performing a random biopsy in women undergoing colposcopy without visible lesions , particularly in those positive for HPV 16 or 18 .
METHODS	: II .

###25399621
BACKGROUND	Pain and potential adverse events ( AE ) remain challenges for patients being treated with calcium hydroxylapatite ( CaHA ; Radiesse ) , especially CaHA not mixed with an anesthetic .
BACKGROUND	The blunt cannula may provide more comfortable and lower risk delivery of CaHA for nasolabial folds ( NLF ) correction .
OBJECTIVE	This 30-day pilot study was designed to compare the effectiveness and safety of standard needles with that of blunt cannulas for CaHA application .
METHODS	Twenty patients with moderate to severe NLF received split-face injections of CaHA mixed with 2 % lidocaine using a cannula for one NLF and needle for the other NLF .
METHODS	At day 0 , patients evaluated pain ; the treating investigator evaluated changes in NLF depth .
METHODS	At 0 , 3 , 7 , 14 , and 30days , the investigator evaluated AEs and NLF correction .
METHODS	Patients recorded AEs in daily dairies .
RESULTS	After initial treatment , patients experienced greater pain and displayed increased erythema and swelling in the needle-treated side .
RESULTS	At days 3 and 7 , patients displayed greater instances of bruising , redness , and swelling in the needle-treated sides .
RESULTS	At day 30 , 19 patients showed slightly better correction in the cannula-treated sides .
CONCLUSIONS	The blunt cannula provided advantages in mitigation of pain and AEs , with a degree of correction similar to needle .
CONCLUSIONS	The addition of blunt cannulas to the clinical setting may be appropriate .

###25637728
OBJECTIVE	The aim of the study was to investigate the effects of the early initiation of passive and active range of motion exercises following arthroscopic rotator cuff repair .
METHODS	The study included 40 patients who underwent arthroscopic rotator cuff repair .
METHODS	Patients were quasi-randomly assigned into accelerated ( ACCEL ) protocol ( n = 19 ) and slow ( SLOW ) protocol ( n = 21 ) groups .
METHODS	Patients in both groups were treated with the same protocol .
METHODS	Active range of motion was begun at the 3rd week in the ACCEL group and the 6th week in the SLOW group .
METHODS	Range of motion was recorded at postoperative weeks 3 , 5 , 8 , 12 , and 24 .
RESULTS	While active range of motion for all measurements improved across weeks , there were no differences between groups , with the exception of active total elevation which was greater at all time point measurements in the ACCEL group ( p < 0.05 ) .
CONCLUSIONS	The early initiation of passive and gentle controlled active motion exercise following rotator cuff repairs does not appear to affect range of motion in the first 6 postoperative months .

###24618345
BACKGROUND	The safety of the manual treatment techniques such as spinal manipulation has been discussed and there is a need for more information about potential adverse events after manual therapy .
BACKGROUND	The aim of this randomized controlled trial was to investigate differences in occurrence of adverse events between three different combinations of manual treatment techniques used by manual therapists ( i.e. chiropractors , naprapaths , osteopaths , physicians and physiotherapists ) for patients seeking care for back and/or neck pain .
BACKGROUND	In addition women and men were compared regarding the occurrence of adverse events .
METHODS	Participants were recruited among patients , ages 18-65 , seeking care at the educational clinic of the Scandinavian College of Naprapathic Manual Medicine in Stockholm .
METHODS	The patients ( n = 767 ) were randomized to one of three treatment arms 1 ) manual therapy ( i.e. spinal manipulation , spinal mobilization , stretching and massage ) ( n = 249 ) , 2 ) manual therapy excluding spinal manipulation ( n = 258 ) and 3 ) manual therapy excluding stretching ( n = 260 ) .
METHODS	Treatments were provided by students in the seventh semester of total eight .
METHODS	Adverse events were measured with a questionnaire after each return visit and categorized in to five levels ; 1 ) short minor , 2 ) long minor , 3 ) short moderate , 4 ) long moderate and 5 ) serious adverse events , based on the duration and/or severity of the event .
METHODS	Generalized estimating equations were used to examine the association between adverse event and treatments arms .
RESULTS	The most common adverse events were soreness in muscles , increased pain and stiffness .
RESULTS	No differences were found between the treatment arms concerning the occurrence of adverse event .
RESULTS	Fifty-one percent of patients , who received at least three treatments , experienced at least one adverse event after one or more visits .
RESULTS	Women more often had short moderate adverse events ( OR = 2.19 ( 95 % CI : 1.52-3 .15 ) ) , and long moderate adverse events ( OR = 2.49 ( 95 % CI : 1.77-3 .52 ) ) compared to men .
CONCLUSIONS	Adverse events after manual therapy are common and transient .
CONCLUSIONS	Excluding spinal manipulation or stretching do not affect the occurrence of adverse events .
CONCLUSIONS	The most common adverse event is soreness in the muscles .
CONCLUSIONS	Women reports more adverse events than men .
BACKGROUND	This trial was registered in a public registry ( Current Controlled Trials ) ( ISRCTN92249294 ) .

###25157992
BACKGROUND	Surgical resection is the only curative treatment for gastric cancer .
BACKGROUND	However , the overall prognosis of gastric adenocarcinoma is poor and advanced disease may even make surgical treatment impossible .
BACKGROUND	It has been theoretically proposed that administration of chemotherapy before surgical resection may down-stage the disease state and facilitate resectability especially in locally-advanced tumors .
OBJECTIVE	We wanted to assess the effect of administration of neoadjuvant chemotherapy on tumor resectability in patients with locally-advances gastric adenocarcinoma .
METHODS	During a randomized-controlled trial , we divided 60 patients with locally-advanced gastric adenocarcinoma into two groups of neoadjuvant chemotherapy and surgery ( case ) versus surgery alone ( control ) .
METHODS	Because of patient dropouts , we analyzed the results for 22 and 29 patients in case and control groups respectively .
METHODS	The study period was March 21 , 2011 to March 20 , 2014 .
METHODS	A non-randomized set of 23 patients were also added to the control group ( Multi-center analysis ) .
METHODS	The analysis was repeated for non-randomized patients ( 22 case patients versus 52 control patients ) .
RESULTS	The mean age of patients in case and control groups was 58.39.1 and 59.78.7 years of age respectively ( p > 0.05 ) .
RESULTS	Male to female ratio was 15/7 and 41/11 in case and control groups respectively ( p > 0.05 ) .
RESULTS	In Randomized patients , 19 patients ( 86.4 % ) were resectable in case group ; while 16 patients ( 55.2 % ) were resectable in control group ( p < 0.05 ) .
RESULTS	Multicenter analysis also revealed resectability in 19 patients ( 86.4 % ) and 31 patients ( 59.6 % ) of case and control groups respectively ( p < 0.05 ) .
CONCLUSIONS	We conclude that neoadjuvant chemotherapy could increase tumor resectability rate in patients with locally-advanced gastric adenocarcinoma .
CONCLUSIONS	However , further studies are necessary to confirm the effect of this modality on patients ' overall survival .

###25822924
BACKGROUND	This study was designed to evaluate and compare the efficacy and safety of nebulized dexmedetomidine , nebulized ketamine , and the combination of these drugs for premedication in pediatric outpatient dental surgeries .
METHODS	A prospective , randomized , double-blinded study was conducted in the Alexandria Main University Hospital after approval of the Medical Ethics Committee .
METHODS	Informed written consent was obtained from the patient 's parents .
METHODS	Sixty children classified as ASA physical status I and II and aged 3 to 6 years were enrolled in the study .
METHODS	Patients were randomly categorized into 3 equal groups .
METHODS	Group K was premedicated with nebulized ketamine ( 2 mg/kg ) , group D was premedicated with nebulized dexmedetomidine ( 2 g/kg ) , and group DK was premedicated with combined nebulized dexmedetomidine and ketamine ( 1 g/kg + 1 mg/kg ) .
METHODS	The primary end point was the level of sedation when the child was first seen in the operating room 30 minutes after sedation .
METHODS	The secondary end points were tolerance of mask induction , hemodynamic changes , analgesia , sedation at emergence , and wake-up behavior .
RESULTS	Studied groups were comparable as regards demographic data ( age , weight , sex , and ASA physical status , all P > 0.226 ) and patients ' acceptance of drugs ( P = 0.968 ) .
RESULTS	Level of sedation at 30 minutes was significantly greater in group DK than in either group K ( P = 0.003 ) or group D ( P = 0.009 ) .
RESULTS	Group DK had the briefest recovery times , followed in order by group K and group D with progressively longer recovery times .
RESULTS	Recovery times were significantly briefer in group DK than in either group K ( P = 0.039 ) or group D ( P < 0.001 ) .
RESULTS	Group DK had significantly briefer discharge times than group D ( P < 0.001 ) .
RESULTS	Postoperative analgesia was significantly better in group DK compared with group K ( P = 0.008 ) .
CONCLUSIONS	A nebulized combination of low-dose ketamine and dexmedetomidine produced more satisfactory sedation and provided a smoother induction of general anesthesia than nebulized ketamine or dexmedetomidine alone , with more rapid recovery and no significant side effects .

###25639140
BACKGROUND	Maternal nutritional status is an important predictor of infant birthweight .
BACKGROUND	Most previous attempts to improve birthweight through multiple micronutrient supplementation have been initiated after women are pregnant .
BACKGROUND	Interventions to improve maternal nutritional status prior to conception may be more effective in preventing low birthweight and improving other infant health outcomes .
OBJECTIVE	To compare the effects of maternal supplementation with animal-source food from preconception to term or from mid-gestation to term with routine prenatal care on birthweight , the prevalence of preterm births , intrauterine growth restriction , and infant growth during the first 12 months of life and on maternal nutrient status and the incidence of maternal and infant infections .
METHODS	Young women from 29 rural communes in northwestern Vietnam were recruited when they registered to marry and were randomized to one of three interventions : animal-source food supplement 5 days per week from marriage to term ( approximately 13 months ) , animal-source food supplement 5 days per week from 16 weeks of gestation to term ( approximately 5 months ) , or routine prenatal care without supplementalfeeding .
METHODS	Data on infant birthweight and gestational age , maternal and infant anthropometry , micronutrient status , and infections in the infant and mother were collected at various time points .
RESULTS	In a preliminary study of women of reproductive age in this area of Vietnam , 40 % of the women were underweight ( body mass index < 18.5 ) and anemic .
RESULTS	About 50 % had infections .
RESULTS	Rice was the dietary staple , and nutrient-rich , animal-source foods were rarely consumed by women .
RESULTS	Iron , zinc , vitamin A , folate , and vitamin B12 intakes were inadequate in about 40 % of the women .
RESULTS	The study is still ongoing , and further data are not yet available .
CONCLUSIONS	The results of this study will provide important data regarding whether improved intake of micronutrient-rich animal-source foods that are locally available and affordable before and during pregnancy improves maternal and infant health and development .
CONCLUSIONS	This food-based approach may have global implications regarding how and when to initiate sustainable nutritional interventions to improve maternal and infant health .

###25197807
OBJECTIVE	Suvorexant , an orexin receptor antagonist , improves sleep in healthy subjects ( HS ) and patients with insomnia .
OBJECTIVE	We compared the electroencephalographic ( EEG ) power spectral density ( PSD ) profile of suvorexant with placebo using data from a phase 2 trial in patients with insomnia .
OBJECTIVE	We also compared suvorexant 's PSD profile with the profiles of other insomnia treatments using data from 3 HS studies .
METHODS	Phase 2 trial -- randomized , double-blind , two-period ( 4 w per period ) crossover .
METHODS	HS studies -- randomized , double-blind , crossover .
METHODS	Sleep laboratories .
METHODS	Insomnia patients ( n = 229 ) or HS ( n = 124 ) .
METHODS	Phase 2 trial -- suvorexant 10 mg , 20 mg , 40 mg , 80 mg , placebo ; HS study 1 -- suvorexant 10 mg , 50 mg , placebo ; HS study 2 -- gaboxadol 15 mg , zolpidem 10 mg , placebo ; HS study 3 -- trazodone 150 mg , placebo .
RESULTS	The PSD of the EEG signal at 1-32 Hz of each PSG recording during nonrapid eye movement ( NREM ) and rapid eye movement ( REM ) sleep were calculated .
RESULTS	The day 1 and day 28 PSD profiles of suvorexant at all four doses during NREM and REM sleep in patients with insomnia were generally flat and close to 1.0 ( placebo ) at all frequencies .
RESULTS	The day 1 PSD profile of suvorexant in HS was similar to that in insomnia patients .
RESULTS	In contrast , the other three drugs had distinct PSD profiles in HS that differed from each other .
CONCLUSIONS	Suvorexant at clinically effective doses had limited effects on power spectral density compared with placebo in healthy subjects and in patients with insomnia , in contrast to the three comparison insomnia treatments .
CONCLUSIONS	These findings suggest the possibility that antagonism of the orexin pathway might lead to improvements in sleep without major changes in the patient 's neurophysiology as assessed by electroencephalographic .

###25447467
BACKGROUND	Novel interventions tailored to blue collar workers are needed to reduce the disparities in smoking rates among occupational groups .
OBJECTIVE	The main objective of this study was to evaluate the efficacy and usage of the Web-enhanced `` Tobacco Tactics '' intervention targeting operating engineers ( heavy equipment operators ) compared to the `` 1-800-QUIT-NOW '' telephone line .
METHODS	Operating engineers ( N = 145 ) attending one of 25 safety training sessions from 2010 through 2012 were randomized to either the Tobacco Tactics website with nurse counseling by phone and access to nicotine replacement therapy ( NRT ) or to the 1-800-QUIT-NOW telephone line , which provided an equal number of phone calls and NRT .
METHODS	The primary outcome was self-reported 7-day abstinence at 30-day and 6-month follow-up .
METHODS	The outcomes were compared using chi-square tests , t tests , generalized mixed models , and logistic regression models .
RESULTS	The average age was 42 years and most were male ( 115/145 , 79.3 % ) and white ( 125/145 , 86.2 % ) .
RESULTS	Using an intent-to-treat analysis , the Tobacco Tactics website group showed significantly higher quit rates ( 18/67 , 27 % ) than the 1-800-QUIT NOW group ( 6/78 , 8 % ) at 30-day follow-up ( P = .003 ) , but this difference was no longer significant at 6-month follow-up .
RESULTS	There were significantly more positive changes in harm reduction measures ( quit attempts , number of cigarettes smoked per day , and nicotine dependence ) at both 30-day and 6-month follow-up in the Tobacco Tactics group compared to the 1-800-QUIT-NOW group .
RESULTS	Compared to participants in the 1-800-QUIT NOW group , significantly more of those in the Tobacco Tactics website group participated in the interventions , received phone calls and NRT , and found the intervention helpful .
CONCLUSIONS	The Web-enhanced Tobacco Tactics website with telephone support showed higher efficacy and reach than the 1-800-QUIT-NOW intervention .
CONCLUSIONS	Longer counseling sessions may be needed to improve 6-month cessation rates .
BACKGROUND	Clinicaltrials.gov NCT01124110 ; http://clinicaltrials.gov/ct2/show/NCT01124110 ( Archived by WebCite at http://www.webcitation.org/6TfKN5iNL ) .

###25372087
BACKGROUND	The National Lung Screening Trial ( NLST ) showed that screening with low-dose computed tomography ( CT ) as compared with chest radiography reduced lung-cancer mortality .
BACKGROUND	We examined the cost-effectiveness of screening with low-dose CT in the NLST .
METHODS	We estimated mean life-years , quality-adjusted life-years ( QALYs ) , costs per person , and incremental cost-effectiveness ratios ( ICERs ) for three alternative strategies : screening with low-dose CT , screening with radiography , and no screening .
METHODS	Estimations of life-years were based on the number of observed deaths that occurred during the trial and the projected survival of persons who were alive at the end of the trial .
METHODS	Quality adjustments were derived from a subgroup of participants who were selected to complete quality-of-life surveys .
METHODS	Costs were based on utilization rates and Medicare reimbursements .
METHODS	We also performed analyses of subgroups defined according to age , sex , smoking history , and risk of lung cancer and performed sensitivity analyses based on several assumptions .
RESULTS	As compared with no screening , screening with low-dose CT cost an additional $ 1,631 per person ( 95 % confidence interval [ CI ] , 1,557 to 1,709 ) and provided an additional 0.0316 life-years per person ( 95 % CI , 0.0154 to 0.0478 ) and 0.0201 QALYs per person ( 95 % CI , 0.0088 to 0.0314 ) .
RESULTS	The corresponding ICERs were $ 52,000 per life-year gained ( 95 % CI , 34,000 to 106,000 ) and $ 81,000 per QALY gained ( 95 % CI , 52,000 to 186,000 ) .
RESULTS	However , the ICERs varied widely in subgroup and sensitivity analyses .
CONCLUSIONS	We estimated that screening for lung cancer with low-dose CT would cost $ 81,000 per QALY gained , but we also determined that modest changes in our assumptions would greatly alter this figure .
CONCLUSIONS	The determination of whether screening outside the trial will be cost-effective will depend on how screening is implemented .
CONCLUSIONS	( Funded by the National Cancer Institute ; NLST ClinicalTrials.gov number , NCT00047385 . )

###25214290
OBJECTIVE	We evaluated the use of tamsulosine versus placebo for management of ureteral stent discomfort .
METHODS	This prospective and randomized study was realized in the Department of Urology of three university hospital .
METHODS	The participation was proposed at all patient having indication to receive an ureteral stent except for cancer .
METHODS	The evaluation of the tolerance used two validate questionnaires : Ureteral Stent Symptom Questionnaire ( USSQ ) and IPSS completed by each patient the day of the insertion , next day , one week later and the day before and after the removal .
METHODS	The main assessment criterion was the question `` global quality of life '' one week after the stent insertion .
RESULTS	Seventy-nine patients were randomized between June , 2010 and October , 2012 .
RESULTS	Despite phone reminders only 38 ( 48.1 % ) were complete questionnaires .
RESULTS	Out of 39 , 18 patients in the tamsulosine group and out of 40 , 20 in the phloroglucinol group .
RESULTS	The majority of the patients ( 92 % ) were included for stone disease .
RESULTS	There is not significant difference between the 2 groups using the USSQ and IPSS at day +1 , day +7 , pre-ablation and day +1 ablation .
RESULTS	A significant improvement of the scores was noted to day +1 by the ablation of the JJ in 2 groups .
CONCLUSIONS	Our study did not show superiority of tamsulosine versus placebo in the improvement of the tolerance of ureteral stent .
METHODS	2 .

###24671721
BACKGROUND	Permissive hypercapnia is a ventilatory strategy used to prevent lung injury in ventilated extremely low birth weight ( ELBW , birth weight 1,000 g ) infants .
BACKGROUND	However , there is retrospective evidence showing that high CO2 is associated with brain injury .
OBJECTIVE	The objective of this study was to compare brain white matter development at term-equivalent age in ELBW infants randomized to hypercapnic vs. normocapnic ventilation during the first week of life and in healthy non-ventilated term newborns .
METHODS	Twenty-two ELBW infants from a randomized controlled trial were included in this study ; 11 received hypercapnic ( transcutaneous PCO2 [ tcPCO2 ] 50-60 mmHg ) ventilation and 11 normocapnic ( tcPCO2 35-45 mmHg ) ventilation during the first week of life while still intubated .
METHODS	In addition , ten term healthy newborns served as controls .
METHODS	Magnetic resonance imaging ( MRI ) with diffusion tensor imaging ( DTI ) was performed at term-equivalent age for the ELBW infants and at approximately 2 weeks of age for the control infants .
METHODS	White matter injury on conventional MRI was graded in the ELBW and control infants using a scoring system adopted from literature .
METHODS	Tract-based spatial statistics ( TBSS ) was used to evaluate for differences in DTI measured fractional anisotropy ( FA , spatially normalized to a customized template ) among the ELBW and term control infants .
RESULTS	Conventional MRI white matter scores were not different ( 7.31.7 vs. 6.91.4 , P = 0.65 ) between the hypercapnic and normocapnic ELBW infants .
RESULTS	TBSS analysis did not show significant differences ( P < 0.05 , corrected ) between the two ELBW infant groups , although before multiple comparisons correction , hypercapnic infants had many regions with lower FA and no regions with higher FA ( P < 0.05 , uncorrected ) compared to normocapnic infants .
RESULTS	When compared to the control infants , normocapnic ELBW infants had a few small regions with significantly lower FA , while hypercapnic ELBW infants had more widespread regions with significantly lower FA ( P < 0.05 , fully corrected for multiple comparisons ) .
CONCLUSIONS	Normocapnic ventilation vs. permissive hypercapnia may be associated with improved white matter development at term-equivalent age in ELBW infants .
CONCLUSIONS	This effect , however , was small and was not apparent on conventional MRI .
CONCLUSIONS	Further research is needed using larger sample sizes to assess if permissive hypercapnic ventilation in ELBW infants is associated with worse white matter development .

###25244442
BACKGROUND	Antidepressants are effective in adults with pain-related functional gastrointestinal disorders .
BACKGROUND	We investigated the effectiveness of citalopram in the treatment of childhood functional abdominal pain ( FAP ) .
METHODS	Children with FAP , based on the Rome III criteria ( n = 115 , aged 6-18 years ) , were randomized to receive either citalopram 20 mg/day or placebo for 4 weeks .
METHODS	Treatment response was defined as 2 point reduction in the 6-point Faces pain rating scale or ` no pain ' .
METHODS	Depression , anxiety , somatization , and physician-rated global severity and improvement were also evaluated .
METHODS	Patients were followed up for 8 weeks after medication period .
RESULTS	Eighty-six patients completed the medication ( 43 in each group ) .
RESULTS	Response rate in the citalopram and placebo groups based on per-protocol ( intention-to-treat ) analysis was 55.8 % ( 40.6 % ) and 39.5 % ( 30.3 % ) at week 4 ( p = 0.097 [ 0.169 ] ) and 72.0 % ( 52.5 % ) and 53.4 % ( 41.0 % ) at week 12 ( p = 0.059 [ 0.148 ] ) , respectively .
RESULTS	In per-protocol analysis , more reduction was observed in pain ( F = 3.84 , p = 0.024 ) and global severity scores ( F = 4.12 , p = 0.021 ) in the citalopram group compared with the placebo group over the study period .
RESULTS	Such differences were not present in the intention-to-treat analysis .
RESULTS	No difference was found between the two groups regarding change in depression , anxiety , or somatization score over the study .
CONCLUSIONS	Overall , we found a trend toward the effectiveness of citalopram in the treatment of children with FAP .
CONCLUSIONS	Trials with longer treatment duration in larger samples of patients are required in this regard .

###25780074
BACKGROUND	Noninvasive continuous positive airway pressure ( CPAP ) is usually applied with a nasal or facial mask to treat mild acute respiratory failure ( ARF ) in infants .
BACKGROUND	A pediatric helmet has now been introduced in clinical practice to deliver CPAP .
BACKGROUND	This study compared treatment failure rates during CPAP delivered by helmet or facial mask in infants with respiratory syncytial virus-induced ARF .
METHODS	In this multicenter randomized controlled trial , 30 infants with respiratory syncytial virus-induced ARF were randomized to receive CPAP by helmet ( n = 17 ) or facial mask ( n = 13 ) .
METHODS	The primary endpoint was treatment failure rate ( defined as due to intolerance or need for intubation ) .
METHODS	Secondary outcomes were CPAP application time , number of patients requiring sedation , and complications with each interface .
RESULTS	Compared with the facial mask , CPAP by helmet had a lower treatment failure rate due to intolerance ( 3/17 [ 17 % ] vs 7/13 [ 54 % ] , P = .009 ) , and fewer infants required sedation ( 6/17 [ 35 % ] vs 13/13 [ 100 % ] , P = .023 ) ; the intubation rates were similar .
RESULTS	In successfully treated patients , CPAP resulted in better gas exchange and breathing pattern with both interfaces .
RESULTS	No major complications due to the interfaces occurred , but CPAP by mask had higher rates of cutaneous sores and leaks .
CONCLUSIONS	These findings confirm that CPAP delivered by helmet is better tolerated than CPAP delivered by facial mask and requires less sedation .
CONCLUSIONS	In addition , it is safe to use and free from adverse events , even in a prolonged clinical setting .

###24657484
OBJECTIVE	TG4040 is a modified vaccinia Ankara ( MVA ) virus that expresses the hepatitis C virus ( HCV ) proteins NS3 , NS4 , and NS5B .
OBJECTIVE	We performed a phase II open-label study to determine the efficacy , safety , and immunotherapeutic properties of TG4040 in combination with pegylated interferon -2 a and ribavirin ( PEG-IFN/RBV ) in patients with chronic HCV infection .
METHODS	Treatment-naive patients with HCV genotype 1 infection were assigned randomly to 1 of thefollowing groups : PEG-IFN/RBV for 48 weeks ( group A , n = 31 ) , PEG-IFN/RBV for 4 weeks followed by PEG-IFN/RBV for 44 weeks with 6 injections of TG4040 ( group B , n = 63 ) , or TG4040 for 12 weeks ( 7 injections ) followed by PEG-IFN/RBV for 48 weeks with 6 injections of TG4040 ( group C , n = 59 ) .
METHODS	The primary end point was complete early virologic response ( cEVR ) , defined as HCV-RNA level less than10 IU/mL after 12 weeks of PEG-IFN/RBV treatment .
RESULTS	In group C , 64.2 % of evaluable patients achieved cEVR , compared with 30.0 % in group A and 45.9 % in group B ( P = .0003 for group C vs A ) .
RESULTS	A higher percentage of patients achieved a sustained virologic response 24 weeks after therapy ended in group C ( 58.2 % ) than in groups A ( 48.4 % ) or B ( 50.8 % ) .
RESULTS	HCV - and MVA-specific T-cell responses were observed predominantly in group C.
RESULTS	As expected , most patients given injections of TG4040 developed anti-MVA antibodies .
RESULTS	The combination of TG4040 and PEG-IFN/RBV was reasonably well tolerated .
RESULTS	However , PEG-IFN-associated thrombocytopenia developed in 3 patients who carried the class II HLA allele DRB01 * 04 .
CONCLUSIONS	A higher percentage of patients with chronic HCV infection who received immunotherapy with TG4040 followed by TG4040 and PEG-IFN/RBV achieved a cEVR compared with patients who received only PEG-IFN/RBV therapy .
CONCLUSIONS	These findings show that immunotherapies that activate T cells are effective in patients with chronic HCV infection .
CONCLUSIONS	ClinicalTrials.gov number , NCT01055821 .

###25231896
OBJECTIVE	We aimed to identify doses of mirogabalin ( DS-5565 ) providing clinically meaningful efficacy with manageable side effects for treatment of diabetic peripheral neuropathic pain ( DPNP ) .
METHODS	Adults ( 18 years ) with type 1 or 2 diabetes , HbAc 10 % at screening , and DPNP for 6 months were eligible for study participation .
METHODS	Subjects ( n = 452 ) were randomized ( 2:1:1:1:1:1:1 ratio ) to placebo , dose-ranging mirogabalin ( 5 , 10 , 15 , 20 , and 30 mg/day ) , or pregabalin ( 300 mg/day ) for 5 weeks .
METHODS	The primary end point was weekly change in average daily pain score ( ADPS ; 0 to 10 numeric rating scale ) from baseline to week 5 ( minimally meaningful effect , 1.0-point decrease versus placebo ) .
METHODS	ANCOVA was conducted using last observation carried forward , and treatment effect least squares ( LS ) means were provided for each contrast .
METHODS	Safety assessments included adverse events ( AEs ) , clinical laboratory tests , and electrocardiograms .
RESULTS	LS mean differences in change in ADPS from baseline to week 5 versus placebo were -0.22 , -0.53 , -0.94 , -0.88 , and -1.01 for the mirogabalin 5 - , 10 - , 15 - , 20 - , and 30-mg/day treatment groups , respectively , and -0.05 in the pregabalin group ( P < 0.05 versus placebo for mirogabalin 15 , 20 , and 30 mg/day ) .
RESULTS	Most frequent AEs ( n = 277 ) were primarily mild to moderate dizziness ( 9.4 % ) , somnolence ( 6.1 % ) , and headache ( 6.1 % ) ; otherwise , mirogabalin was well tolerated .
CONCLUSIONS	Mirogabalin 15 , 20 , and 30 mg/day had statistically significant reductions in ADPS versus placebo , and mirogabalin 30 mg/day also met the criteria of minimally meaningful effect .
CONCLUSIONS	Mirogabalin may be a promising new treatment option for patients with DPNP .

###25249430
OBJECTIVE	Flexible fiber-optic bronchoscope-guided orotracheal intubation is a valuable technique with demonstrated benefits in the management of difficult airways .
OBJECTIVE	Despite its popularity with anesthesia providers , the technique is not fail-safe and airway-related complications secondary to failed intubation attempts remain an important problem .
OBJECTIVE	We sought to determine the effect of incorporating lingual traction on the success rate of fiber-optic bronchoscope-guided intubation in patients with anticipated difficult airways .
METHODS	In this prospective , randomized , cohort study , we enrolled 91 adult patients with anticipated difficult airways scheduled for elective surgery to undergo fiber-optic bronchoscope-guided orotracheal intubation alone or with lingual traction by an individual anesthesiologist after induction of general anesthesia and neuromuscular blockade .
METHODS	A total of 78 patients were randomized : 39 patients to the fiber-optic bronchoscope-guided intubation with lingual traction group and 39 patients to the fiber-optic bronchoscope-guided intubation alone group .
METHODS	The primary endpoint was the rate of successful first attempt intubations .
METHODS	The secondary outcome was sore throat grade on post-operative day 1 .
RESULTS	Fiber-optic intubation with lingual traction compared to fiber-optic intubation alone resulted in a higher success rate ( 92.3 vs. 74.4 % , ( 2 ) = 4.523 , p = 0.033 ) and greater odds for successful first attempt intubation ( OR 4.138 , 95 % CI 1.041-16 .444 , p = 0.044 ) .
RESULTS	Sore throat severity on post-operative day 1 was not significantly different but trended towards worsening grades with lingual traction .
CONCLUSIONS	In this study , lingual traction was shown to be a valuable maneuver for facilitating fiber-optic bronchoscope-guided intubation in the management of patients with anticipated difficult airways .

###24279294
BACKGROUND	Levels of physical activity ( PA ) in UK children are much lower than recommended and novel approaches to its promotion are needed .
BACKGROUND	The Children , Parents and Pets Exercising Together ( CPET ) study is the first exploratory randomised controlled trial ( RCT ) to develop and evaluate an intervention aimed at dog-based PA promotion in families .
BACKGROUND	CPET aimed to assess the feasibility , acceptability and potential efficacy of a theory-driven , family-based , dog walking intervention for 9-11 year olds .
METHODS	Twenty-eight families were allocated randomly to either receive a 10-week dog based PA intervention or to a control group .
METHODS	Families in the intervention group were motivated and supported to increase the frequency , intensity and duration of dog walking using a number of behaviour change techniques .
METHODS	Parents in the intervention group were asked to complete a short study exit questionnaire .
METHODS	In addition , focus groups with parents and children in the intervention group , and with key stakeholders were undertaken .
METHODS	The primary outcome measure was 10 week change in total volume of PA using the mean accelerometer count per minute ( cpm ) .
METHODS	Intervention and control groups were compared using analysis of covariance .
METHODS	Analysis was performed on an intention to treat basis .
RESULTS	Twenty five families were retained at follow up ( 89 % ) and 97 % of all outcome data were collected at baseline and follow up .
RESULTS	Thirteen of 14 ( 93 % ) intervention group parents available at follow up completed the study exit questionnaire and noted that study outcome measures were acceptable .
RESULTS	There was a mean difference in child total volume of PA of 27 cpm ( 95 % CI -70 , 123 ) and -3 cpm ( 95 % CI -60 , 54 ) for intervention and control group children , respectively .
RESULTS	This was not statistically significant .
RESULTS	Approximately 21 % of dog walking time for parents and 39 % of dog walking time for children was moderate-vigorous PA. .
CONCLUSIONS	The acceptability of the CPET intervention and outcome measures was high .
CONCLUSIONS	Using pet dogs as the agent of lifestyle change in PA interventions in children and their parents is both feasible and acceptable , but did not result in a significant increase in child PA in this exploratory trial .
BACKGROUND	ISRCTN85939423 .

###24530676
OBJECTIVE	The aim of this study was to assess the prognostic performance of C-terminal provasopressin ( copeptin ) , midregional pro-adrenomedullin ( MR-proADM ) , and midregional pro-atrial natriuretic peptide ( MR-proANP ) in a large prospective cohort of patients with non-ST-segment elevation acute coronary syndrome ( NSTE-ACS ) .
BACKGROUND	Copeptin , MR-proADM , and MR-proANP are emerging biomarkers of hemodynamic stress that have been associated with adverse cardiovascular ( CV ) outcomes in heart failure ( HF ) and stable ischemic disease .
METHODS	We measured copeptin , MR-proADM , and MR-proANP concentrations in 4,432 patients with NSTE-ACS who were randomized to treatment with ranolazine or placebo in the MERLIN-TIMI 36 ( Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST-Elevation Acute Coronary Syndromes-Thrombolysis In Myocardial Infarction 36 ) trial and followed up for 1 year .
RESULTS	A high concentration ( quartile 4 vs. quartiles 1 to 3 ) of each biomarker identified an increased risk of CV death or HF ( copeptin : 13.2 % vs. 5.0 % , p < 0.001 ; MR-proADM : 15.8 % vs. 4.1 % , p < 0.001 ; MR-proANP : 17.7 % vs. 3.5 % , p < 0.001 ) as well as CV death , HF , and myocardial infarction individually ( all p 0.001 ) .
RESULTS	After adjustment for important covariates , each biomarker remained associated with CV death or HF at 1 year ( adjusted hazard ratio : copeptin , 1.71 ; MR-proADM , 1.96 ; MR-proANP , 2.20 ; all p 0.001 ) .
RESULTS	These biomarkers improved prognostic discrimination and patient re-classification for CV death or HF at 1 year ( all categorical NRI > 10 % , p < 0.001 ) , and maintained independent association with composite CV death or HF when concurrently assessed in a model with clinical indicators plus BNP , cTnI , ST2 , PAPP-A , and MPO ( each p0 .01 ) [ corrected ] .
CONCLUSIONS	Copeptin , MR-proADM , and MR-proANP are complementary prognostic markers for CV death and HF in patients with NSTE-ACS that perform as well as or better than established and other emerging biomarkers and warrant further investigation of application for therapeutic decision making .
CONCLUSIONS	( Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes ; NCT00099788 ) .

###24731231
BACKGROUND	Glutamine rate of appearance ( Ra ) may be used as an estimate of endogenous glutamine production .
BACKGROUND	Recently a technique employing a bolus injection of isotopically labeled glutamine was introduced , with the potential to allow for multiple assessments of the glutamine Ra over time in critically ill patients , who may not be as metabolically stable as healthy individuals .
BACKGROUND	Here the technique was used to evaluate the endogenous glutamine production in critically ill patients in the fed state with and without exogenous glutamine supplementation intravenously .
METHODS	Mechanically ventilated patients ( n = 11 ) in the intensive care unit ( ICU ) were studied on two consecutive days during continuous parenteral feeding .
METHODS	To allow the patients to be used as their own controls , they were randomized for the reference measurement during basal feeding without supplementation , before or after the supplementation period .
METHODS	Glutamine Ra was determined by a bolus injection of 13C-glutamine followed by a period of frequent sampling to establish the decay-curve for the glutamine tracer .
METHODS	Exogenous glutamine supplementation was given by intravenous infusion of a glutamine containing dipeptide , L-alanyl-L-glutamine , 0.28 g/kg during 20 hours .
RESULTS	A 14 % increase of endogenous glutamine Ra was seen at the end of the intravenous supplementation period as compared to the basal measurements ( P = 0.009 ) .
CONCLUSIONS	The bolus injection technique to measure glutamine Ra to estimate the endogenous production of glutamine in critically ill patients was demonstrated to be useful for repetitive measurements .
CONCLUSIONS	The hypothesized attenuation of endogenous glutamine production during L-alanyl-L-glutamine infusion given as a part of full nutrition was not seen .

###24848838
OBJECTIVE	The purpose of this study was to evaluate the effect of the use of preoperative breast MRI on surgical and long-term outcomes among women with early-stage breast cancer undergoing breast conservation therapy .
METHODS	A retrospective review yielded the cases of 174 women with stage 0 , I , or II breast cancer who underwent preoperative MRI between 2000 and 2004 .
METHODS	A control group of 174 patients who did not undergo preoperative MRI before breast conservation therapy was matched by age , histopathologic finding , stage , and surgeon .
METHODS	Features compared included breast density , presence of mammographically occult disease , margin status , lymph node involvement , lymphovascular invasion , extensive intraductal component , hormone receptor status , and use of adjuvant therapy .
METHODS	Outcomes , including rates of reexcision , ipsilateral recurrence , and disease-free survival , were compared by Kaplan-Meier methods and the log-rank test .
RESULTS	Patients referred for preoperative breast MRI were more likely to have extremely dense breasts ( 28 % vs 6 % , p < 0.0001 ) and mammographically occult cancer ( 24 % vs 9 % , p = 0.0003 ) .
RESULTS	The two groups had identical rates of final negative margins , lymph node involvement , lymphovascular invasion , extensive intraductal component status , positive hormone receptor results , and systemic adjuvant therapy .
RESULTS	Fewer patients in the preoperative MRI group needed reexcision ( 29 % vs 45 % , p = 0.02 ) .
RESULTS	The median follow-up period after treatment was 8 years .
RESULTS	There was no significant difference in locoregional recurrence ( p = 0.33 ) or disease-free survival ( p = 0.73 ) rates between the two groups .
CONCLUSIONS	Reexcision rates among patients with early breast cancer undergoing conservation therapy were lower among women who underwent preoperative breast MRI .
CONCLUSIONS	There was no statistically significant effect of the use of preoperative MRI on rates of locoregional recurrence or disease-free survival .

###24930201
BACKGROUND	Pulmonary rehabilitation ( PR ) is an evidence-based intervention in patients with chronic obstructive pulmonary disease ( COPD ) which improves the exercise capacity and quality of life ( QoL ) .
METHODS	We studied 60 patients after an episode of acute exacerbation of COPD ( AECOPD ) .
METHODS	They were randomised to receive conventional treatment without pulmonary rehabilitation ( CTWPR ) ( n = 30 ) or , standard treatment plus a 12-week post-exacerbation pulmonary rehabilitation ( PEPR ) programme in addition .
METHODS	Assessment of exercise capacity by six minute walk test ( 6MWT ) and QoL measured by St George 's Respiratory Questionnaire ( SGRQ ) were carried out initially and at the end of three months .
RESULTS	The baseline characteristics of both the groups were found to be similar .
RESULTS	There was a statistically significant increase in the six minute walk distance ( 6MWD ) ( increase by 37.9 meters , p < 0.001 ) and a significant decline in the total SGRQ score ( by 3.8 units p < 0.001 ) in the PEPR group compared to CTWPR group .
CONCLUSIONS	Early pulmonary rehabilitation in patients with an AECOPD has significant benefits on the QoL and exercise capacity .

###24720551
OBJECTIVE	A phase IIa study investigated efficacy and safety/tolerability of ascending doses of mavrilimumab ( anti-granulocyte-macrophage colony-stimulating factor receptor [ GM-CSFR ] monoclonal antibody ) in adult subjects with moderate to severe rheumatoid arthritis from Japan and Europe .
OBJECTIVE	Findings from the Japanese population are presented .
METHODS	Fifty-one subjects received mavrilimumab ( 10-100 mg ) or placebo subcutaneously every other week for 12 weeks , followed by a 12-week follow-up period .
METHODS	The primary endpoint was the proportion of subjects achieving a Disease Activity Score using 28 joints ( DAS28 ) - C-reactive protein ( CRP ) response ( decrease > 1.2 from baseline ) .
METHODS	Secondary endpoints included DAS28-CRP remission , Health Assessment Questionnaire Disability Index ( HAQ-DI ) and American College of Rheumatology ( ACR ) response .
RESULTS	By Week 12 , more mavrilimumab - versus placebo-treated subjects achieved a DAS28-CRP response ( 50.0 % vs. 23.5 % , p = 0.081 ) ; a significant response was seen in the 30 mg and 100 mg dose groups ( both 75.0 % vs. 23.5 % , p = 0.028 ) .
RESULTS	The 100 mg group also demonstrated statistically significant HAQ-DI and ACR20 responses at Week 12 .
RESULTS	Results were generally consistent between Japanese and European populations .
RESULTS	Overall , adverse events ( AEs ) were mild to moderate in intensity with one serious AE of pneumonia , considered possibly treatment-related .
CONCLUSIONS	A rapid and clinically meaningful response was seen in subjects treated with GM-CSFR blockade with mavrilimumab , supporting further investigation of mavrilimumab for the treatment of RA in Japanese subjects .

###25440273
BACKGROUND	We compared the antiinflammatory and cardioprotective effects of the two most common regimens of corticosteroid administration in pediatric cardiac surgical procedures : a single dose delivered either at anesthesia induction or by cardiopulmonary bypass ( CPB ) prime .
METHODS	Forty-five children , aged between 1 and 18 months and undergoing ventricular septal or atrioventricular septal defect correction , were randomized in double-blind fashion into three groups .
METHODS	The anesthesia induction group received 30 mg/kg methylprednisolone intravenously after anesthesia induction , and the CPB-prime group received 30 mg/kg methylprednisolone by CPB circuit .
METHODS	The placebo group received saline solution .
METHODS	Plasma concentrations of methylprednisolone , interleukin ( IL ) -6 , IL-8 and IL-10 , and troponin were measured at anesthesia induction before the study drug , 30 minutes on CPB , after patients were weaned from CPB , and 6 hours after cessation of CPB .
RESULTS	Equally high methylprednisolone concentrations were detected in both methylprednisolone groups , but the measured peak concentration occurred earlier in the induction group .
RESULTS	Significantly lower IL-8 concentrations were observed just after patients were weaned from and 6 hours after CPB in the anesthesia induction group compared with the placebo ( p = 0.002 , p = 0.001 ) and prime groups ( p = 0.003 , p = 0.006 ) .
RESULTS	Significant reductions of troponin were detected in both methylprednisolone groups compared with placebo ( induction , p = 0.001 ; prime , p = 0.002 ) 6 hours after patients were weaned from CPB .
CONCLUSIONS	Methylprednisolone administration at anesthesia induction was superior in terms of antiinflammatory action .
CONCLUSIONS	Methylprednisolone administration in CPB-prime only a few minutes before aortic cross-clamping and cardioplegia resulted in mean troponin reductions similar to those of administration at anesthesia induction .
CONCLUSIONS	Corticosteroids may have direct cardioprotective properties , as reported in experimental studies .

###25112175
OBJECTIVE	To determine whether the postoperative administration of tryptophan would be beneficial for elderly adults undergoing surgery who are at risk of developing postoperative delirium .
METHODS	Randomized , double-blind , placebo-controlled trial .
METHODS	Denver Veterans Affairs Medical Center .
METHODS	Individuals aged 60 and older undergoing major elective operations requiring a postoperative intensive care unit ( ICU ) admission ( n = 325 ) .
METHODS	L-tryptophan , 1g orally three times a day or placebo was started after surgery and continued for up to 3days postoperatively .
METHODS	Delirium and its motor subtypes were measured using the Confusion Assessment Method-Intensive Care Unit ( CAM-ICU ) and the Richmond Agitation and Sedation Scale .
METHODS	The primary outcome for between-group comparison was the incidence of excitatory ( mixed and hyperactive ) postoperative delirium .
METHODS	The secondary outcomes for comparison were the incidence and duration of overall postoperative delirium .
RESULTS	The overall incidence of postoperative delirium was 39 % ( 95 % confidence interval = 34-44 % ) ( n = 116 ) .
RESULTS	Seventeen percent of participants in the tryptophan group and 9 % in the placebo group had excitatory delirium ( P = .18 ) , and the duration of excitatory delirium was 3.31.7 days for tryptophan and 3.11.9 days for placebo ( P = .74 ) .
RESULTS	Forty percent of participants in the tryptophan group and 37 % in the placebo group had overall delirium ( P = .60 ) , and the duration of overall delirium was 2.91.8 days for tryptophan and 2.41.6 days for placebo ( P = .17 ) .
CONCLUSIONS	Postoperative tryptophan supplementation in older adults undergoing major elective operations requiring postoperative ICU admission did not reduce the incidence or duration of postoperative excitatory delirium or overall delirium .

###25358330
BACKGROUND	Optimizing vancomycin dosing may help eradicate bacteria while avoiding resistance .
BACKGROUND	The guidelines recommend loading doses ; however , there are no data to demonstrate that this may result in a more rapid achievement of therapeutic troughs .
OBJECTIVE	To evaluate the percentage of troughs reaching therapeutic levels at 12 , 24 , and 36 hours following an initial vancomycin dose of 30 mg/kg compared with 15 mg/kg .
METHODS	This prospective , randomized study was performed in a community academic medical center .
METHODS	Patients who were to receive vancomycin in the emergency department were randomized to an initial traditional dose of 15 mg/kg or a 30-mg/kg loading dose followed by 15 mg/kg every 12 hours for 3 doses .
METHODS	Patients weighing > 120 kg or with creatinine clearances < 50 mL/min were excluded .
RESULTS	In total , 99 patients were enrolled ; 12 hours after the initial dose of vancomycin , there was a significantly greater proportion of patients reaching target trough levels of 15 mg/L among the patients who received a loading dose as compared with a traditional dose ( 34 % vs 3 % , P < 0.01 ) .
RESULTS	This trend continued at 24 hours but was not statistically significant .
RESULTS	At 36 hours , there was no difference in the percentage of patients reaching target levels between the 2 groups .
RESULTS	No statistically significant difference in nephrotoxicity or adverse events among the 2 groups was demonstrated .
CONCLUSIONS	A loading dose of 30 mg/kg of vancomycin achieved a higher percentage of therapeutic levels at 12 hours when compared with the traditional dose of 15 mg/kg , without increased nephrotoxicity or adverse events .

###24472122
BACKGROUND	United States pediatric guidelines recommend that childhood obesity counseling be conducted in the primary care setting .
BACKGROUND	Primary care-based interventions can be effective in improving health behaviors , but also costly .
BACKGROUND	The purpose of this study was to evaluate the cost of a primary care-based obesity prevention intervention targeting children between the ages of two and six years who are at elevated risk for obesity , measured against usual care .
METHODS	High Five for Kids was a cluster-randomized controlled clinical trial that aimed to modify children 's nutrition and TV viewing habits through a motivational interviewing intervention .
METHODS	We assessed visit-related costs from a societal perspective , including provider-incurred direct medical costs , provider-incurred equipment costs , parent time costs and parent out-of-pocket costs , in 2011 dollars for the intervention ( n = 253 ) and usual care ( n = 192 ) groups .
METHODS	We conducted a net cost analysis using both societal and health plan costing perspectives and conducted one-way sensitivity and uncertainty analyses on results .
RESULTS	The total costs for the intervention group and usual care groups in the first year of the intervention were $ 65,643 ( 95 % CI [ $ 64,522 , $ 66,842 ] ) and $ 12,192 ( 95 % CI [ $ 11,393 , $ 13,174 ] ) .
RESULTS	The mean costs for the intervention and usual care groups were $ 259 ( 95 % CI [ $ 255 , $ 264 ] ) and $ 63 ( 95 % CI [ $ 59 , $ 69 ] ) per child , respectively , for a incremental difference of $ 196 ( 95 % CI [ $ 191 , $ 202 ] ) per child .
RESULTS	Children in the intervention group attended a mean of 2.4 of a possible 4 in-person visits and received 0.45 of a possible 2 counseling phone calls .
RESULTS	Provider-incurred costs were the primary driver of cost estimates in sensitivity analyses .
CONCLUSIONS	High Five for Kids was a resource-intensive intervention .
CONCLUSIONS	Further studies are needed to assess the cost-effectiveness of the intervention relative to other pediatric obesity interventions .

###24750838
OBJECTIVE	To investigate the efficacy of letrozole for delaying bone maturation and increasing predicted adult height in boys with idiopathic central precocious puberty ( ICPP ) who have a bone age above 13 years and a short stature , and its adverse effects .
METHODS	Twenty ICPP boys with a bone age above 13 years and a short stature were randomly divided into letrozole treatment ( n = 10 ) and control groups ( n = 10 ) .
METHODS	The letrozole treatment group received oral letrozole [ 2.5 mg / ( m ( 2 ) d ) , Qd ] for 6 months , while the control group received no treatment and was observed periodically .
METHODS	Bone age , growth rate , height standard deviation ( SD ) score , predicted adult height SD score , sexual maturity , and levels of follicle-stimulating hormone ( FSH ) , luteinizing hormone ( LH ) , dehydroepiandrosterone , testosterone ( T ) , estradiol ( E2 ) , progesterone ( P ) , and androstenedione ( ASD ) were measured .
METHODS	The letrozole-related adverse reactions were evaluated .
RESULTS	After 6 months of treatment , both groups had a significantly increased bone age , but the letrozole group had a significantly slowed increase in bone age compared with the control group ( 13.82 0.23 years vs 14.47 0.30 years ; P < 0.05 ) ; compared with the control group , the letrozole group had a significantly increased predicted adult height SD score ( -1.69 0.26 vs -1.91 0.35 ; P < 0.05 ) and a significantly increased T level ( 4.9 0.9 nmol/L vs 4.4 0.8 nmol/L ; P < 0.05 ) .
RESULTS	There was no significant difference in testicular volume between the two groups .
RESULTS	The treatment led to no significant changes in growth rate , Tanner stage , and levels of FSH , LH , P , E2 and ASD in the two groups , and there was no significant difference in these indices between the two groups .
RESULTS	No adverse reactions were observed during letrozole treatment .
CONCLUSIONS	Letrozole delays bone maturation and increases predicted adult height in ICPP boys with a bone age above 13 years and a short stature , and it causes no obvious adverse reactions .

###25393358
OBJECTIVE	In percutaneous nephrolithotomy ( PCNL ) , placement of the access tract into the kidney is an important aspect of the procedure and is responsible for the steep learning curve associated with the operation .
OBJECTIVE	The aim of the current prospective randomized trial was to assess the duration of radiation exposure along with the safety and efficacy of PCNL done by a trainee , utilizing either ultrasonography ( US ) or fluoroscopic guidance to obtain access .
METHODS	Sixty-four patients with 3cm renal calculi undergoing single-tract PCNL by trainee urologists ( experience of < 25 PCNL 's ) were randomized into US - and fluoroscopic-guided access groups ( 32 in each ) .
METHODS	In Group 1 ( US guided ) , puncture was done using a 3.5 / 5MHz US probe with a puncture attachment , whereas the triangulation technique with biplanar C-arm fluoroscopy was utilized in group 2 ( fluoroscopic guided ) .
METHODS	Patient demographics , stone parameters , intraoperative characteristics , fluoroscopy durations , and postoperative outcomes were analyzed .
RESULTS	Both groups were comparable as far as patient and stone characteristics were concerned .
RESULTS	The fluoroscopy exposure during the puncture phase ( T2 ) and overall ( T ) was significantly lower in the US group at 9.020.8 vs 43.834.8 , ( p < 0.0001 ) and 204.384 vs 239.977.5 , ( p = 0.04 ) .
RESULTS	Six patients in group1 required fluoroscopic adjustment ( p = 0.03 ) .
RESULTS	All other intra - and postoperative parameters were similar in both the groups .
CONCLUSIONS	Both ultrasound and fluoroscopic guidance for renal access are equally safe and feasible in the hands of a trainee urologist .
CONCLUSIONS	Total fluoroscopy duration and exposure time during puncture were both significantly less in the ultrasound group .
CONCLUSIONS	Expertise in fluoroscopic-guided access is essential for a novice to effectively achieve access in all possible situations .

###24652604
BACKGROUND	Hangeshashinto ( TJ-14 , a Kampo medicine ) , which reduces the level of prostaglandin E2 and affects the cyclooxygenase activity , alleviates chemotherapy-induced oral mucositis ( COM ) .
BACKGROUND	We conducted a randomized comparative trial to investigate whether TJ-14 prevents and controls COM in patients with gastric cancer .
METHODS	We randomly assigned patients with gastric cancer who developed moderate-to-severe oral mucositis ( CTCAE v4 .0 grade 1 ) during any cycle of chemotherapy to receive either TJ-14 or a placebo as a double-blind trial .
METHODS	The patients received a placebo or TJ-14 for 2-6 weeks according to the chemotherapy regimen from the beginning of the next course of chemotherapy .
METHODS	The primary end point was the incidence of grade 2 oral mucositis in the protocol treatment course , and the secondary end points were the time to disappearance of oral mucositis and the incidence of adverse events .
RESULTS	Following the key opening of the blinding protocol , we analyzed 91 eligible patients ( TJ-14 : 45 , placebo : 46 ) using a `` per protocol set '' analysis .
RESULTS	The incidence of grade 2 COM was 40.0 % in the TJ-14 group and 41.3 % in the placebo group ( p = 0.588 ) .
RESULTS	The median duration of grade 2 COM was 14 days in the TJ-14 group and 16 days in the placebo group ( p = 0.894 ) .
RESULTS	Meanwhile , the median duration of any grade of COM was 9 days in the TJ-14 group and 17 days in the placebo group among the patients who developed grade 1 symptoms during the screening cycle [ hazard ratio 0.60 ; 95 % CI ( 0.23-1 .59 ) , p = 0.290 ] .
CONCLUSIONS	Although TJ-14 treatment did not reduce the incidence of 2 COM in the patients who developed mucositis during chemotherapy for gastric cancer , a trend was observed in which TJ-14 reduced the risk of COM in the patients who developed grade 1 COM during the screening cycle .
CONCLUSIONS	Further , phase III studies with a larger sample size are needed to clarify the protective effects of TJ-14 for COM .

###24577154
BACKGROUND	Genetic information , typically communicated in-person by genetic counselors , can be challenging to comprehend ; delivery of this information online -- as is becoming more common -- has the potential of increasing these challenges .
METHODS	To address the impact of the mode of delivery of genomic risk information , 300 individuals were recruited from the general public and randomized to receive genomic risk information for type 2 diabetes mellitus in-person from a board-certified genetic counselor or online through the testing company 's website .
RESULTS	Participants were asked to indicate their genomic risk and overall lifetime risk as reported on their test report as well as to interpret their genomic risk ( increased , decreased , or same as population ) .
RESULTS	For each question , 59 % of participants correctly indicated their risk .
RESULTS	Participants who received their results in-person were more likely than those who reviewed their results on-line to correctly interpret their genomic risk ( 72 vs. 47 % , p = 0.0002 ) and report their actual genomic risk ( 69 vs. 49 % , p = 0.002 ) .
CONCLUSIONS	The delivery of personal genomic risk through a trained health professional resulted in significantly higher comprehension .
CONCLUSIONS	Therefore , if the online delivery of genomic test results is to become more widespread , further evaluation of this method of communication may be needed to ensure the effective presentation of results to promote comprehension .

###24280743
BACKGROUND	A high prevalence of hyperandrogenism has been reported in women with type 1 diabetes ( T1D ) .
BACKGROUND	Metformin has been used as a therapeutic agent in patients with polycystic ovarian syndrome and in T1D patients without hyperandrogenism .
BACKGROUND	This study sought to determine the effect of metformin on hyperandrogenism and ovarian function in adolescents with T1D .
METHODS	We recruited 24 girls with T1D .
METHODS	The participants had hyperandrogenism and displayed suboptimal metabolic control .
METHODS	The patients were enrolled in a randomized , double-blind , placebo-controlled trial .
METHODS	One group received metformin ( 850 mg bid ) and the other group received a placebo .
METHODS	Treatment was administered for 9 months .
METHODS	Ovulation , steroids and gonadotropin levels were evaluated .
RESULTS	Metformin treatment was associated with decreases in testosterone , free androgen index , androstenedione , 17-OH progesterone and estradiol levels .
RESULTS	The girls who were treated with placebo showed stable steroid , gonadotropin and sex hormone-binding globulin levels during the analysis .
RESULTS	No differences were observed in the Ferriman-Gallwey scores , ovulation rates , HbA1c levels or daily insulin doses of the girls treated with metformin compared with the placebo group .
CONCLUSIONS	Treating hyperandrogenic T1D adolescents with metformin significantly decreased the serum androgens compared to the placebo , but metformin therapy did not significantly affect clinical parameters , such as hirsutism , ovulation and metabolic control .

###25591521
OBJECTIVE	To explore the dynamics of aggregation of platelets and erythrocytes , their deformity and computed morphodensitometric parameters in patients with chronic cerebral ischemia , stages I and II , treated with cerebrolysin .
METHODS	We examined 300 patients , including 87 men and 213 women , aged from 30 to 55 years .
METHODS	Patients were randomized by disease stage and treatment ( standard treatment with or without cerebrolysin ) .
METHODS	The dynamics of neurological and emotional status as well as cognitive functions and results of laboratory studies were assessed .
CONCLUSIONS	Along with the total positive effect of cerebrolysin on the clinical picture , additional mechanisms of its action ( antiaggregant , antihypoxic and membranotropic ) improved the erythrocyte morphodensitometric parameters , hemostatic , hemorheological and blood gas transport characteristics , in particular on the microcirculatory level .

###25158772
OBJECTIVE	The Secondary Prevention of Small Subcortical Stroke trial ( SPS3 ) recruited participants meeting clinical and radiological criteria for symptomatic lacunes .
OBJECTIVE	Individuals randomized to dual antiplatelet therapy with clopidogrel and aspirin had an unanticipated increase in all-cause mortality compared with those assigned to aspirin .
OBJECTIVE	We investigated the factors associated with mortality in this well-characterized population .
METHODS	We identified independent predictors of mortality among baseline demographic and clinical factors by Cox regression analysis in participants of the SPS3 trial .
METHODS	Separately , we examined the effect on mortality of nonfatal bleeding during the trial .
RESULTS	During a mean follow-up of 3.6 years , the mortality rate was 1.78 % per year for the 3020 participants ( mean age , 63 years ) .
RESULTS	Significant independent predictors of mortality at study entry were age , diabetes mellitus , history of hypertension , systolic blood pressure ( hazard ratio [ HR ] , 1.3 per 20 mm Hg increase ) , serum hemoglobin < 13 g/dL ( HR , 1.6 ) , renal function ( HR , 1.3 per estimated glomerular filtration rate decrease of 20 mL/min ) , and body mass index ( HR , 1.8 per 10 kg/m2 decrease ) .
RESULTS	Participants with ischemic heart disease ( P = 0.01 for interaction ) and normotensive/prehypertensive participants ( P = 0.03 for interaction ) were at increased risk if assigned to dual antiplatelet therapy .
RESULTS	Nonfatal major hemorrhage increased mortality in both treatment arms ( HR , 4.5 ; 95 % confidence interval , 3.1-6 .6 ; P < 0.001 ) .
CONCLUSIONS	Unexpected interactions between assigned antiplatelet therapy and each of ischemic heart disease and normal/prehypertensive status accounted for increased mortality among patients with recent lacunar stroke given dual antiplatelet therapy .
CONCLUSIONS	Despite extensive exploratory analyses , the mechanisms underlying these interactions are uncertain .
BACKGROUND	http://www.SPS3ClinicalTrials.gov .
BACKGROUND	Unique identifier : NCT00059306 .

###24824197
OBJECTIVE	To investigate the efficacy and safety of the dipeptidyl peptidase-4 inhibitor linagliptin in patients with Type2 diabetes mellitus inadequately controlled by a combination of metformin and pioglitazone .
METHODS	This was a multi-centre , phase3 , randomized , double-blind , placebo-controlled study comparing linagliptin 5mg once daily ( n = 183 ) and placebo ( n = 89 ) as add-on to metformin and pioglitazone .
METHODS	The primary endpoint was the change from baseline in glycated haemoglobin ( HbA1c ) after 24weeks .
RESULTS	The placebo-corrected adjusted mean ( se ) change in HbA1c from baseline to 24weeks was -6 ( 1 ) mmol/mol [ -0.57 ( 0.13 ) % ] ( P < 0.0001 ) .
RESULTS	In patients with baseline HbA1c 53mmol/mol ( 7.0 % ) , 32.4 % of patients in the linagliptin group and 13.8 % in the placebo group achieved HbA1c < 53mmol/mol ( 7.0 % ) ( odds ratio2 .94 ; P = 0.0033 ) .
RESULTS	The placebo-corrected adjusted mean ( se ) change from baseline in fasting plasma glucose at week24 was -0.57 ( 0.26 ) mmol/l [ -10.4 ( 4.7 ) mg/dl ] ( P = 0.0280 ) .
RESULTS	The incidence of serious adverse events was 2.2 % with linagliptin and 3.4 % with placebo .
RESULTS	Investigator-defined hypoglycaemia occurred in 5.5 % of the linagliptin group and 5.6 % of the placebo group .
RESULTS	No meaningful changes in mean body weight were noted for either group .
CONCLUSIONS	Linagliptin as add-on therapy to metformin and pioglitazone produced significant and clinically meaningful improvements in glycaemic control , without an additional risk of hypoglycaemia or weight gain ( Clinical Trials Registry No : NCT 00996658 ) .

###25138128
OBJECTIVE	The study aimed at comparing the effectiveness and maternal satisfaction of oral misoprostol with vaginal misoprostol for induction of labor at term .
METHODS	A randomized controlled trial of 140 term pregnant women at the University of Nigeria Teaching Hospital Enugu , Nigeria , was conducted from April 2011 to May 2012 .
METHODS	The women were equally randomized into two groups ( A and B ) to receive oral and vaginal misoprostol , respectively .
RESULTS	The vaginal route reduced the mean induction-vaginal delivery interval by four-and-half hours ( 20.7 12.1 vs. 16.2 10.4 ; mean difference : 4.50 , 95 % CI 0.63-0 .82 ; p = 0.02 ) .
RESULTS	Furthermore , the mean dose of misoprostol required to achieve induction of labor and the mean duration of oxytocin augmentation when indicated were significantly less in the vaginal group than in the oral group ( 2.5 1.3 vs. 2.0 1.1 ; mean difference : 0.50 , 95 % CI 0.10-0 .90 ; p = 0.02 and 4.6 3.2 vs. 3.4 3.1 ; mean difference : 1.20 , 95 % CI 0.15-0 .23 ; p = 0.03 respectively ) .
RESULTS	However , neonatal complications and maternal satisfaction were similar between the two groups .
CONCLUSIONS	Both routes of administration are effective in the induction of labor at term and have comparable maternal satisfaction .
CONCLUSIONS	However , the vaginal route has the added advantage of shorter induction-delivery interval among others , and thus should be highly considered when induction of labor is indicated at term .

###24523666
BACKGROUND	The incidence of acute kidney injury ( AKI ) is increasing globally and it is much more common than end-stage kidney disease .
BACKGROUND	AKI is associated with high mortality and cost of hospitalisation .
BACKGROUND	Studies of treatments to reduce this high mortality have used differing renal replacement therapy ( RRT ) modalities and have not shown improvement in the short term .
BACKGROUND	The reported long-term outcomes of AKI are variable and the effect of differing RRT modalities upon them is not clear .
BACKGROUND	We used the prolonged follow-up of a large clinical trial to prospectively examine the long-term outcomes and effect of RRT dosing in patients with AKI .
RESULTS	We extended the follow-up of participants in the Randomised Evaluation of Normal vs. Augmented Levels of RRT ( RENAL ) study from 90 days to 4 years after randomization .
RESULTS	Primary and secondary outcomes were mortality and requirement for maintenance dialysis , respectively , assessed in 1,464 ( 97 % ) patients at a median of 43.9 months ( interquartile range [ IQR ] 30.0-48 .6 months ) post randomization .
RESULTS	A total of 468/743 ( 63 % ) and 444/721 ( 62 % ) patients died in the lower and higher intensity groups , respectively ( risk ratio [ RR ] 1.04 , 95 % CI 0.96-1 .12 , p = 0.49 ) .
RESULTS	Amongst survivors to day 90 , 21 of 411 ( 5.1 % ) and 23 of 399 ( 5.8 % ) in the respective groups were treated with maintenance dialysis ( RR 1.12 , 95 % CI 0.63-2 .00 , p = 0.69 ) .
RESULTS	The prevalence of albuminuria among survivors was 40 % and 44 % , respectively ( p = 0.48 ) .
RESULTS	Quality of life was not different between the two treatment groups .
RESULTS	The generalizability of these findings to other populations with AKI requires further exploration .
CONCLUSIONS	Patients with AKI requiring RRT in intensive care have high long-term mortality but few require maintenance dialysis .
CONCLUSIONS	Long-term survivors have a heavy burden of proteinuria .
CONCLUSIONS	Increased intensity of RRT does not reduce mortality or subsequent treatment with dialysis .
BACKGROUND	www.ClinicalTrials.govNCT00221013 .

###24250305
OBJECTIVE	The incidence of non-alcoholic fatty liver disease ( NAFLD ) is increasing dramatically affecting up to 30 % of the population worldwide .
OBJECTIVE	At present , treatment options are limited and pharmacological management of NAFLD has had disappointing results .
OBJECTIVE	Some of the best available evidence to improve NAFLD concerns lifestyle modification .
OBJECTIVE	To detect the degree of weight reduction needed to improve the markers of hepatic function and insulin resistance in type-2 diabetics with NAFLD .
METHODS	One hundred type-2 diabetic male patients with NAFLD were included into this study and divided into two equal groups .
METHODS	Group ( A ) received aerobic exercise training in addition to diet regimen .
METHODS	Group ( B ) received no treatment intervention .
RESULTS	There was a 26.99 % , 40.8 % , 33.81 % , 32.73 % , 37.8 % and 15 % reduction in mean values of Alkaline Phosphatase ( ALP ) , Alanine Aminotransferase ( ALT ) , Aspartate Aminotransferase ( AST ) , Gamma - Glutamyltransferase ( GGT ) and Homeostasis Model Assessment-Insulin Resistance-index ( HOMA-IR ) and BMI respectively in group ( A ) at the end of the study .
RESULTS	While there were significant differences between mean levels of the investigated parameters in group ( A ) and group ( B ) after treatment .
CONCLUSIONS	About 15 % reduction in BMI is effective to improve the liver condition and insulin resistance in type-2 diabetics with NAFLD .

###24279841
BACKGROUND	Major depressive disorder ( MDD ) is a prevalent and severe disorder .
BACKGROUND	Although effective treatments for MDD are available , many patients remain untreated , mainly because of insufficient treatment capacities in the health care system .
BACKGROUND	Resulting waiting periods are often associated with prolonged suffering and impairment as well as a higher risk of chronification .
BACKGROUND	Web-based interventions may help to alleviate these problems .
BACKGROUND	Numerous studies provided evidence for the efficacy of web-based interventions for depression .
BACKGROUND	The aim of this study is to evaluate a new web-based guided self-help intervention ( GET.ON-Mood Enhancer-WL ) specifically developed for patients waiting to commence inpatient therapy for MDD .
METHODS	In a two-armed randomised controlled trial ( n = 200 ) , the web-based guided intervention GET.ON-Mood Enhancer-WL in addition to treatment as usual ( TAU ) will be compared with TAU alone .
METHODS	The intervention contains six modules ( psycho education , behavioural activation I & II , problem solving I & II , and preparation for subsequent inpatient depression therapy ) .
METHODS	The participants will be supported by an e-coach , who will provide written feedback after each module .
METHODS	Inclusion criteria include a diagnosis of MDD assessed with a structured clinical interview [ SCID ] and a waiting period of at least three weeks before start of inpatient treatment .
METHODS	The primary outcome is observer-rated depressive symptom severity ( HRSD24 ) .
METHODS	Further ( explorative ) questions include whether remission will be achieved earlier and by more patients during inpatient therapy because of the web-based preparatory intervention .
CONCLUSIONS	If GET.ON-Mood Enhancer-WL is proven to be effective , patients may start inpatient therapy with reduced depressive symptom severity , ideally leading to higher remission rates , shortened inpatient therapy , reduced costs , and decreased waiting times .
BACKGROUND	German Clinical Trial Registration ( DRKS ) : DRKS00004708 .

###25645789
BACKGROUND	Development of obesity after heart transplantation ( HT ) is a common complication , largely attributed to immunosuppressive therapy .
BACKGROUND	The objective of this study is to compare the incidence of development of obesity after HT , according to the calcineurin inhibitor ( CNI ) used ( cyclosporine [ CsA ] vs tacrolimus [ Tac ] ) .
METHODS	We studied 101 consecutive HT patients from November 2006 to December 2010 .
METHODS	A diagnosis of overweight-obesity was made by a body mass index of 25 kg/m ( 2 ) , which was assessed before HT and at 1 year after HT .
METHODS	Patients were randomly assigned to the administration of CsA or Tac by a simple randomization method using a computer program ( 56 % received CsA and 44 % Tac ) .
RESULTS	Of the 101 patients , 77 % were men , and ischemic heart disease was the most common indication for HT .
RESULTS	At baseline , there were no differences in weight between groups treated with CsA or Tac .
RESULTS	The mean weight for each group was 71.5 12 and 75 14 kg , respectively ( P = .2 ) .
RESULTS	The weight increase was greater among CsA patients : after HT , the weight gain was 6.9 11 kg in the CsA group , whereas a minimal weight loss of 0.03 14 kg ( P = .008 ) was experienced in the group treated with Tac .
RESULTS	The multivariate analysis showed that only CsA treatment was an independent predictor of development of obesity 1 year after HT ( odds ratio , 3.84 ; 95 % CI , 1.04-14 .21 ; P = .01 ) .
CONCLUSIONS	Weight gain after HT may be related to the CNI used and CsA seems to be the CNI that produces the greatest increase .

###24457893
OBJECTIVE	To examine whether greater exposure to resin-based composite materials , which may intra-orally release bisphenol A ( BPA ) , is associated with worse renal function outcomes in children .
METHODS	Prospective multi-centre study .
METHODS	Community health dental clinics in Boston and Maine from 1997-2005 .
METHODS	Subjects and methods Five hundred and thirty-four New England Children 's Amalgam Trial participants aged six to ten years were randomised to treatment with amalgam or resin-based composite restorations over five years of follow-up .
METHODS	Restorations were placed according to treatment arm , and sealants placed per standard of care .
METHODS	Cumulative composite exposure was calculated using surface-years ( each treated surface weighted by number years present ) .
METHODS	Urinary excretion of albumin , gamma-glutamyl transpeptidase ( gamma-GT ) , and N-acetyl -- D-glucosaminidase ( NAG ) were available for 417 children .
RESULTS	Analysis of covariance showed no association between exposure to dental composites , polyacid-modified compomer , or flowable composite dental sealants and preventative resin restorations with levels of renal function .
RESULTS	There was no association between composite materials and thresholds indicating renal damage in logistic regression models .
CONCLUSIONS	This study found no harmful associations between dental composite materials and renal function in children .
CONCLUSIONS	Therefore , concerns about renal function need not be a consideration in the choice of dental restoration material or placement of preventative dental sealants .

###25888086
BACKGROUND	The Organ Care System is the only clinical platform for ex-vivo perfusion of human donor hearts .
BACKGROUND	The system preserves the donor heart in a warm beating state during transport from the donor hospital to the recipient hospital .
BACKGROUND	We aimed to assess the clinical outcomes of the Organ Care System compared with standard cold storage of human donor hearts for transplantation .
METHODS	We did this prospective , open-label , multicentre , randomised non-inferiority trial at ten heart-transplant centres in the USA and Europe .
METHODS	Eligible heart-transplant candidates ( aged > 18 years ) were randomly assigned ( 1:1 ) to receive donor hearts preserved with either the Organ Care System or standard cold storage .
METHODS	Participants , investigators , and medical staff were not masked to group assignment .
METHODS	The primary endpoint was 30 day patient and graft survival , with a 10 % non-inferiority margin .
METHODS	We did analyses in the intention-to-treat , as-treated , and per-protocol populations .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00855712 .
RESULTS	Between June 29 , 2010 , and Sept 16 , 2013 , we randomly assigned 130 patients to the Organ Care System group ( n = 67 ) or the standard cold storage group ( n = 63 ) .
RESULTS	30 day patient and graft survival rates were 94 % ( n = 63 ) in the Organ Care System group and 97 % ( n = 61 ) in the standard cold storage group ( difference 28 % , one-sided 95 % upper confidence bound 88 ; p = 045 ) .
RESULTS	Eight ( 13 % ) patients in the Organ Care System group and nine ( 14 % ) patients in the standard cold storage group had cardiac-related serious adverse events .
CONCLUSIONS	Heart transplantation using donor hearts adequately preserved with the Organ Care System or with standard cold storage yield similar short-term clinical outcomes .
CONCLUSIONS	The metabolic assessment capability of the Organ Care System needs further study .
BACKGROUND	TransMedics .

###24695896
BACKGROUND	Interactions between calcium and vitamin D may have implications for the regulation of serum 25-hydroxyvitamin D [ 25 ( OH ) D ] and its catabolism and , consequently , the vitamin D dietary requirement .
OBJECTIVE	We investigated whether different calcium intakes influenced serum 25 ( OH ) D and indexes of vitamin D activation and catabolism during winter and in the context of both adequate and inadequate vitamin D intakes .
METHODS	A 15-wk winter-based , randomized , placebo-controlled , double-blind vitamin D intervention ( 20 g/d ) study was carried out in free-living men and women aged 50 y ( n = 125 ) who were stratified according to calcium intakes [ moderate-low ( < 700 mg/d ) or high ( > 1000 mg/d ) intake ] .
METHODS	The serum 25 ( OH ) D concentration was the primary outcome , and serum calcium , parathyroid hormone ( PTH ) , 1,25-dihydroxyvitamin D [ 1,25 ( OH ) D ] , 24,25-dihydroxyvitamin D [ 24,25 ( OH ) D ] , the ratio of 24,25 ( OH ) D to 25 ( OH ) D , vitamin D-binding protein , and free 25 ( OH ) D were exploratory outcomes .
RESULTS	A repeated-measures ANOVA showed there was no significant ( P = 0.2 ) time vitamin D treatment calcium intake grouping interaction effect on the mean serum 25 ( OH ) D concentration over the 15-wk intervention period .
RESULTS	Serum 25 ( OH ) D concentrations increased ( P 0.005 ) and decreased ( P 0.002 ) in vitamin D and placebo groups , respectively , and were of similar magnitudes in subjects with calcium intakes < 700 mg/d ( and even < 550 mg/d ) compared with > 1000 mg/d .
RESULTS	The response of serum PTH , 1,25 ( OH ) D , 24,25 ( OH ) D , the ratio of 24,25 ( OH ) D to 25 ( OH ) D , and free 25 ( OH ) D significantly differed in vitamin D and placebo groups but not by calcium intake grouping .
CONCLUSIONS	We found no evidence of a vitamin D sparing effect of high calcium intake , which has been referred to by some authors as `` vitamin D economy . ''
CONCLUSIONS	Thus , recent dietary vitamin D requirement estimates will cover the vitamin D needs of even those individuals who have inadequate calcium intakes .

###24316679
BACKGROUND	A recent Cochrane Review showed that early robotic training of the upper limb in stroke survivors can be more effective than other interventions when improving activities of daily living involving the arm function is the aim of therapy .
OBJECTIVE	We tested for efficacy of the study a protocol which involved the use of the NeReBot therapy in partial substitution of standard upper limb rehabilitation in post-acute stroke patients .
METHODS	In this dose-matched , randomized controlled clinical trial , 34 hemiparetic participants with movement against gravity in shoulder , elbow , and wrist muscle groups were enrolled within 15 days of the onset of stroke .
METHODS	All participants received a total daily rehabilitation treatment for 120 minutes , 5 days per week for 5 weeks .
METHODS	The control group received standard therapy for the upper limb .
METHODS	The experimental group received standard therapy ( 65 % of exercise time ) associated with robotic training ( 35 % of exercise time ) .
METHODS	Muscle tone ( Modified Ashworth Scale ) , strength ( Medical Research Council ) , and synergism ( Fugl-Meyer motor scores ) were measured at impairment level , whereas dexterity ( Box and Block Test and Frenchay Arm Test ) and activities of daily living ( Functional Independence Measure ) were measured at activity level .
METHODS	All assessments were performed at baseline , at the end of therapy ( time T1 ) , at 3 months ( time T2 ) , and at 7 months ( time T3 ) after entry .
METHODS	All between-group analyses were tested using nonparametric test with Bonferroni 's adjustments for multiple testing .
RESULTS	No significant between-group differences were found with respect to demographic characteristics , motor , dexterity , and ADLs at baseline , postintervention ( T1 ) and at follow-up ( T2 and T3 ) .
CONCLUSIONS	The robot therapy by NeReBot did not lead to better outcomes compared with conventional inpatient rehabilitation .

###24657434
BACKGROUND	Preventing smoking initiation among adolescents is crucial to reducing tobacco-caused death and disease .
BACKGROUND	This study focuses on the effectiveness of a Web-based computer-tailored smoking prevention intervention aimed at adolescents .
OBJECTIVE	The intent of the study was to describe the intervention characteristics and to show the effectiveness and results of a randomized controlled trial .
OBJECTIVE	We hypothesized that the intervention would prevent smoking initiation among Dutch secondary school students aged 10-20 years and would have the largest smoking prevention effect among the age cohort of 14-16 years , as smoking uptake in that period is highest .
METHODS	The intervention consisted of a questionnaire and fully automated computer-tailored feedback on intention to start smoking and motivational determinants .
METHODS	A total of 89 secondary schools were recruited via postal mail and randomized into either the computer-tailored intervention condition or the control condition .
METHODS	Participants had to complete a Web-based questionnaire at baseline and at 6-month follow-up .
METHODS	Data on smoking initiation were collected from 897 students from these schools .
METHODS	To identify intervention effects , multilevel logistic regression analyses were conducted using multiple imputation .
RESULTS	Smoking initiation among students aged 10-20 years was borderline significantly lower in the experimental condition as compared to the control condition 6 months after baseline ( OR 0.25 , 95 % CI 0.05-1 .21 , P = .09 ) .
RESULTS	Additional analyses of the data for the 14-16 year age group showed a significant effect , with 11.5 % ( 24/209 ) of the students in the control condition reporting initiation compared to 5.7 % ( 10/176 ) in the experimental condition ( OR 0.22 , 95 % CI 0.05-1 .02 , P = .05 ) .
RESULTS	No moderation effects were found regarding gender and educational level .
CONCLUSIONS	The findings of this study suggest that computer-tailored smoking prevention programs are a promising way of preventing smoking initiation among adolescents for at least 6 months , in particular among the age cohort of 14-16 years .
CONCLUSIONS	Further research is needed to focus on long-term effects .
BACKGROUND	International Standard Randomized Controlled Trial Number ( ISRCTN ) : 77864351 ; http://www.controlled-trials.com/ISRCTN77864351 ( Archived by WebCite at http://www.webcitation.org/6BSLKSTm5 ) .

###24288221
OBJECTIVE	Endoscopic biliary sphincterotomy and stone removal is the standard of care for choledocholithiasis , with a success rate of > 90 % .
OBJECTIVE	For stones 25 mm diameter , mechanical lithotripsy , extracorporeal shock wave lithotripsy , electrohydraulic lithotripsy , and laser lithotripsy can be used .
OBJECTIVE	In the case of failure , the next step is surgery .
OBJECTIVE	In elderly patients and in patients with an elevated surgical risk , stenting is the only treatment modality .
OBJECTIVE	In these cases the aim is to avoid the onset of acute obstructive cholangitis .
OBJECTIVE	The aim of the current study was to evaluate the best management of plastic stents in patients with biliary duct stones who were unfit for surgery and in whom previous endoscopic therapy had failed .
METHODS	Patients who were high surgical risks and in whom stone clearance was not possible due to the number and sizes of stones were included .
METHODS	Between March 2008 and September 2010 all patients were treated with endoscopic plastic biliary stenting at four tertiary care referral centers in Italy .
METHODS	Patients were randomly assigned to two groups : in Group A ( n = 39 ) plastic stents were changed every 3 months or sooner if symptoms appeared ; in Group B plastic stents were changed on demand at the onset of symptoms , and ultrasonography and blood samples were performed every 3 months to check for signs of cholestasis and inflammation .
METHODS	The primary outcome was the rate of cholangitis .
METHODS	The secondary outcome was the rate of stone clearance after a period of stenting .
RESULTS	A total of 78 patients were included in the study ( 43M/35F ; mean age 76 years ) .
RESULTS	Acute cholangitis occurred in 3 patients from Group A and in 14 patients from Group B ( P = 0.03 ) .
RESULTS	Mortality related to cholangitis occurred in one patient from Group A and three patients from Group B ( P = n.s. ) .
RESULTS	The mean follow-up was 13.5 months ( range 2-23 ) .
RESULTS	Stone clearance after long term stenting occurred in 24 patients from Group A ( 61.5 % ) and in 21 patients from group B ( 53.8 % ) ( P = n.s. ) .
CONCLUSIONS	In patients with bile duct stones who were treated with biliary plastic stents , the best stent management to avoid cholangitis was stent changing at defined intervals ( every 3 months in the current study ) .
CONCLUSIONS	The data confirmed that plastic biliary stenting may decrease stone size with a high percentage of subsequent total stone clearance .

###24391768
BACKGROUND	Previous analyses from a randomized trial in women aged 24-45 have shown the quadrivalent HPV vaccine to be efficacious in the prevention of infection , cervical intraepithelial neoplasia ( CIN ) and external genital lesions ( EGL ) related to HPV 6/11/16 / 18 through 4 years .
BACKGROUND	In this report we present long term follow-up data on the efficacy , safety and immunogenicity of the quadrivalent HPV vaccine in adult women .
METHODS	Follow-up data are from a study being conducted in 5 sites in Colombia designed to evaluate the long-term immunogenicity , effectiveness , and safety of the qHPV vaccine in women who were vaccinated at 24 to 45 years of age ( in the original vaccine group during the base study [ n = 684 ] ) or 29 to 50 years of age ( in the original placebo group during the base study [ n = 651 ] ) .
METHODS	This analysis summarizes data collected as of the year 6 post-vaccination visit relative to day 1 of the base study ( median follow-up of 6.26 years ) from both the original base study and the Colombian follow-up .
RESULTS	There were no cases of HPV 6/11/16 / 18-related CIN or EGL during the extended follow-up phase in the per-protocol population .
RESULTS	Immunogenicity persists against vaccine-related HPV types , and no evidence of HPV type replacement has been observed .
RESULTS	No new serious adverse experiences have been reported .
CONCLUSIONS	Vaccination with qHPV vaccine provides generally safe and effective protection from HPV 6 - , 11 - , 16 - , and 18-related genital warts and cervical dysplasia through 6 years following administration to 24-45 year-old women .
BACKGROUND	Clinicaltrials.govNCT00090220 .

###25912752
OBJECTIVE	To evaluate whether trabectedin as first-line chemotherapy for advanced/metastatic soft tissue sarcoma prolongs progression-free survival ( PFS ) , compared to doxorubicin and , in the phase IIb part here , to select the most appropriate trabectedin treatment schedule ( 3-hour or 24-hour infusion ) in terms of safety , convenience and efficacy .
METHODS	In this randomised multicentre prospective dose-selection phase IIb superiority trial , 133 patients were randomised between doxorubicin ( n = 43 ) , trabectedin ( 3-hour infusion , T3h ) ( n = 47 ) and trabectedin ( 24-hour infusion , T24h ) ( n = 43 ) .
METHODS	PFS was defined as time from random assignment until objective progression by response evaluation criteria in solid tumours ( RECIST 1.1 ) , a global deterioration of the health status requiring discontinuation of the treatment , or death from any cause .
RESULTS	The study was terminated due to lack of superiority in both trabectedin treatment arms as compared to the doxorubicin control arm .
RESULTS	Median PFS was 2.8 months in the T3h arm , 3.1 months in the T24h arm and 5.5 months in the doxorubicin arm .
RESULTS	No significant improvements in PFS were observed in the trabectedin arms as compared to the doxorubicin arm ( T24h versus doxorubicin : hazard ratio ( HR ) 1.13 , 95 % confidence interval ( CI ) 0.67-1 .90 , P = .675 ; T3h versus doxorubicin : HR 1.50 , 95 % CI 0.91-2 .48 , P = .944 ) .
RESULTS	Only one toxic death occurred in the T3h arm , but treatment had to be stopped due to toxicity in 7 ( 15.2 % ) ( T3h ) , 8 ( 19.5 % ) ( T24h ) and 1 ( 2.5 % ) doxorubicin patients .
CONCLUSIONS	Doxorubicin continues to be the standard treatment in eligible patients with advanced/metastatic soft-tissue sarcoma ( STS ) .
CONCLUSIONS	Trabectedin 1.5 mg/m ( 2 ) / 24-hour infusion is the overall proven approach to delivering this agent in the second-line setting for patients with advanced or metastatic STS .

###24569327
BACKGROUND	Esophageal cancer is among the most common gastrointestinal cancers for which the main treatment is surgery .
BACKGROUND	This study was undertaken to analyze the results of Botox injection in preventing gastric stasis in these patients .
METHODS	60 patients with esophageal cancer in the middle and lower third parts were included in our study between 2010 and 2011 , and were randomly divided into two groups .
METHODS	In group A , 30 patients underwent pyloroplasty , and in group B , injection of botulinum toxin into the pyloric sphincter muscle was used in 30 patients .
RESULTS	The mean age of these patients was 6110.7 years and the male/female ratio was 33:27 .
RESULTS	Isotope scans 3 weeks after surgery showed that 5 patients in group A and 3 in group B had delayed gastric emptying ; there was no significant difference between the 2 groups , and the success rate of Botox injection was 90 % .
CONCLUSIONS	Considering the fact that there was no significant difference between pyloroplasty and Botox injection on gastric emptying after surgery , and given the need to use less-aggressive techniques and facilitate greater use of endoscopic methods , botulinum toxin injection may be used instead of pyloroplasty as a simple , effective , and complication-free method to prevent delayed gastric emptying .

###25057140
BACKGROUND	Social support is associated with enhanced illness management and recovery in persons with mental illness , making it an important topic addressed through acute inpatient psychoeducational programs .
BACKGROUND	In addition , trust in the therapist may mediate clinical outcomes in this patient population .
BACKGROUND	To date , few studies have examined the effect of music-based psychoeducational programs on these variables .
OBJECTIVE	The purpose of this study was to isolate and examine the component parts of a live educational music therapy intervention , and its effect on acute psychiatric inpatients ' perceived social support from significant others , family , and friends and trust in the therapist .
OBJECTIVE	This study also explored whether trust in therapist varied across conditions , but did not examine it as a mediator for social support .
METHODS	Participants ( N = 96 ) were cluster-randomized in a single-session posttest-only design to one of four conditions : live educational music therapy , recorded educational music therapy , education without music , or recreational music therapy without education .
METHODS	Conditions were designed to isolate the following intervention components : live vs. recorded music , educational vs. non-educational content , and music vs. nonmusic modality .
METHODS	Dependent measures were assessed post intervention via established self-report instruments evaluating perceived social support and trust in the therapist .
RESULTS	There were no significant between-group differences for social support or trust in therapist total scores .
RESULTS	However , subscale score analyses revealed two significant between-group differences : ( a ) participants in the Live Educational Music Therapy condition reported significantly higher perceived therapist competence compared with the Recorded Educational Music Therapy condition ; ( b ) participants in the Live Educational Music Therapy condition reported significantly higher perceived support from friends compared with the Recreational Music Therapy condition .
CONCLUSIONS	Live educational music therapy may be a way to heighten psychiatric inpatients ' perceived social support concerning friends and perceptions of the therapist 's competence .
CONCLUSIONS	The current results demonstrated differences between live and recorded music therapy in psychiatric music therapy and provide empirical support for competent musicianship .
CONCLUSIONS	Implications for clinical practice , limitations , and suggestions for future research are included .

###25122497
BACKGROUND	Hyperventilation has been associated with adverse effects on lung function , symptoms , and well-being in asthma .
BACKGROUND	We examined whether raising end-tidal CO2 levels ( ie , Pco2 ) compared with slow breathing is associated with improvements in asthma control , including peak flow variability .
METHODS	One hundred twenty patients with asthma were randomly assigned to capnometry-assisted respiratory training ( CART ) for raising Pco2 or slow breathing and awareness training ( SLOW ) for slowing respiratory rate .
METHODS	Patients received five weekly sessions and completed bid homework exercises over 4 weeks .
METHODS	Blinded assessments at baseline , posttreatment , 1 - and 6-month follow-up of asthma control , Pco2 , and diurnal peak flow variability were primary outcome measures .
METHODS	Additionally , we measured pulmonary function ( spirometry , forced oscillation , exhaled nitric oxide , and methacholine challenge ) , symptoms , quality of life , and bronchodilator use .
METHODS	Because the control group received active treatment , we expected improvements in asthma control in both groups but more pronounced benefits from CART .
RESULTS	Improvements were seen in 17 of 21 clinical indexes ( 81.0 % ) in both interventions , including the primary outcome variables asthma control ( d = 0.81 ) , peak flow variability ( d = 0.54 ) , quality of life , bronchodilator use , lung function , and airway hyperreactivity .
RESULTS	Most improvements were sustained across the 6-month follow-up .
RESULTS	Compared with slow breathing , CART showed greater increases in Pco2 ( d = 1.45 vs 0.64 for CART vs SLOW , respectively ) and greater reductions in respiratory impedance during treatment , less distress during methacholine challenge , and greater reduction in asthma symptoms at follow-up ( P < .05 ) .
CONCLUSIONS	Brief interventions aimed at raising Pco2 or slowing respiratory rate provide significant , sustained , and clinically meaningful improvements in asthma control .
CONCLUSIONS	Raising Pco2 was associated with greater benefits in aspects of lung function and long-term symptoms .
BACKGROUND	ClinicalTrials.gov ; No. : NCT00975273 ; URL : www.clinicaltrials.gov .

###25467077
BACKGROUND	Selective serotonin reuptake inhibitors ( SSRIs ) are common treatments for patients with major depressive disorder ( MDD ) .
BACKGROUND	However , adverse effects of SSRIs on sexual function are common in the treatment of patients with MDD .
BACKGROUND	There is a discrepancy in the reported frequency of SSRI-induced sexual dysfunction .
BACKGROUND	On the other hand , there is also less evidence about sexual dysfunction with serotonin receptor antagonists and reuptake inhibitors ( SARIs ) .
BACKGROUND	Therefore , we aimed to assess sexual dysfunction in MDD patients who received fluoxetine , sertraline and trazodone .
METHODS	In a single-blind , randomized , controlled trial in Kermanshah , Iran , during 2009-2010 , 195 patients who met the DSMIV-IR criteria for MDD were enrolled .
METHODS	The patients completed the Hamilton Depression Rating Scale ( HAM-D ) and the sexual function questionnaire ( SFQ ) .
METHODS	Eligible patients were allocated in three treatment groups ( receiving fluoxetine , sertraline or trazodone ) for 14 weeks randomly .
METHODS	Measurement of HAMD was repeated in 4-week interval .
METHODS	Analysis for comparing sexual dysfunction among three groups and men and women was performed .
RESULTS	There were 102 men and 93 women in the three groups receiving fluoxetine ( n = 64 ) , sertraline ( n = 67 ) and trazodone ( n = 64 ) .
RESULTS	There was no significant difference in the sexual dysfunction of the patients in the three groups at baseline ( P > .05 ) .
RESULTS	After treatment , both men and women who had received fluoxetine had the most impairment in desire/drive items ( 43 % -51 % and 44 % -50 % , respectively ) , while patients receiving trazodone had the least impairment in these items ( 12 % -18 % and 23 % -24 % , respectively ) .
RESULTS	Trazodone was also induced with a lower rate of impairment in arousal/orgasm items in men ( 9 % -15 % ) compared with the other two drugs .
RESULTS	Compared with fluoxetine and trazodone , sertraline was associated with intermediate impairment in sexual function ( 39 % -42 % in desire/drive items and 32 % -39 % in arousal/orgasm items ) that was lower than that with fluoxetine and more than that with trazodone .
CONCLUSIONS	There were different rates of sexual dysfunction with different antidepressants drugs in under treated patients .
CONCLUSIONS	Compared with fluoxetine , and sertraline , trazodone was associated with the fewest sexual dysfunction .
CONCLUSIONS	Fluoxetine was also associated with more sexual dysfunction than sertraline .
CONCLUSIONS	Further research to better identify the differences among antidepressant drugs is recommended .

###24911028
OBJECTIVE	To evaluate the potential efficacy of buspirone as a relapse-prevention treatment for cocaine dependence .
METHODS	A randomized , double-blind , placebo-controlled , 16-week pilot trial was conducted at 6 clinical sites between August 2012 and June 2013 .
METHODS	Adult crack cocaine users meeting DSM-IV-TR criteria for current cocaine dependence who were scheduled to be in inpatient/residential substance use disorder ( SUD ) treatment for 12-19 days when randomized and planning to enroll in local outpatient treatment through the end of the active treatment phase were randomized to buspirone titrated to 60 mg/d ( n = 35 ) or placebo ( n = 27 ) .
METHODS	All participants received psychosocial treatment as usually provided by the SUD treatment programs in which they were enrolled .
METHODS	Outcome measures included maximum days of continuous cocaine abstinence ( primary ) , proportion of cocaine use days , and days to first cocaine use during the outpatient treatment phase ( study weeks 4-15 ) as assessed by self-report and urine drug screens .
RESULTS	There were no significant treatment effects on maximum continuous days of cocaine abstinence or days to first cocaine use .
RESULTS	In the female participants ( n = 23 ) , there was a significant treatment-by-time interaction effect ( = 15.26 , P < .0001 ) , reflecting an increase in cocaine use by those receiving buspirone , relative to placebo , early in the outpatient treatment phase .
RESULTS	A similar effect was not detected in the male participants ( n = 39 ; = 0.14 , P = .70 ) .
CONCLUSIONS	The results suggest that buspirone is unlikely to have a beneficial effect on preventing relapse to cocaine use and that buspirone for cocaine-dependent women may worsen their cocaine use outcomes .
BACKGROUND	ClinicalTrials.gov identifier : NCT01641159 .

###24330604
BACKGROUND	People with intellectual disabilities ( ID ) have lower levels of physical activity and quality of life and they have a lot of barriers to face when taking part in physical activity .
BACKGROUND	Other problems are the poor adherence to physical activity such people have so this study is designed to improve adherence to physical activity for people with intellectual disabilities with the assistance of an application for smartphones .
BACKGROUND	The aim of the study will be to improve physical activity and physical condition after multimodal intervention and to analyse the promotion of adherence to physical activity through a multimodal intervention and an app intervention ( mHealth ) in people with ID .
METHODS	A two-stage study will be conducted .
METHODS	In stage 1 a multimodal intervention will take place will be done with physical activity and educational advice over eight weeks , two days a week .
METHODS	Data will be measured after and before the intervention .
METHODS	In stage 2 a randomized controlled trial will be conducted .
METHODS	In the intervention group we will install an application to a smartphone ; this application will be a reminder to do a physical activity and they have to select whether they have or have n't done a physical activity every day .
METHODS	This application will be installed for 18 weeks .
METHODS	Data will be measured after and before the application is installed in two groups .
METHODS	We will measure results 10 weeks later when the two groups do n't have the reminder .
METHODS	The principal outcome used to measure the adherence to physical activity will be the International Physical Activity Questionnaire ; secondary outcomes will be a fun-fitness test and self-report survey about quality of life , self-efficacy and social support .
METHODS	Samples will be randomized by sealed envelope in two groups , with approximately 20 subjects in each group .
METHODS	It 's important to know that the therapist will be blinded and wo n't know the subjects of each group .
CONCLUSIONS	Offering people with ID a multimodal intervention and tool to increase the adherence to a physical activity may increase the levels of physical activity and quality of life .
CONCLUSIONS	Such a scheme , if beneficial , could be implemented successfully within public health sense .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01915381 .

###25424120
BACKGROUND	We report updated progression-free survival ( PFS ) and overall survival ( OS ) data from a trial that compared capecitabine plus oxaliplatin ( CapeOX ) versus S-1 plus oxaliplatin ( SOX ) for the first-line treatment of metastatic colorectal cancer .
METHODS	This trial was a randomized , two-armed , non-inferiority phase 3 comparison of CapeOX ( capecitabine 1000 mg/m2 twice daily on days 1-14 and oxaliplatin 130 mg/m2 on day 1 ) versus SOX ( S-1 40 mg/m2 twice daily on days 1-14 and oxaliplatin 130 mg/m2 on day 1 ) .
METHODS	The primary end point was to show non-inferiority of SOX relative to CapeOX in terms of PFS .
METHODS	Thus , a follow-up exploratory analysis of PFS and OS was performed .
RESULTS	The intention to treat ( ITT ) population was comprised of 340 patients ( SOX arm : 168 and CapeOX arm : 172 ) .
RESULTS	The updated median PFS was 7.1 months ( 95 % CI 6.4-8 .0 ) in the SOX group and 6.3 months ( 95 % CI 4.9-6 .7 ) in the CapeOX group ( hazard ratio [ HR ] , 0.83 [ 0.66-1 .04 ] , p = .10 ) .
RESULTS	The median OS was 19.0 months ( 95 % CI 15.3-23 .0 ) in the SOX group and 18.4 months ( 95 % CI 14.1-20 .7 ) in the CapeOX group ( HR , 0.86 [ 0.68-1 .08 ] , p = .19 ) .
RESULTS	Subgroup analyses according to principal demographic factors such as sex , age , ECOG ( Eastern Cooperative Oncology Group ) performance status , primary tumor location , measurability , previous adjuvant therapy , number of metastatic organs , and liver metastases showed no interaction between any of these characteristics and the treatment .
CONCLUSIONS	Updated survival analysis shows that SOX is similar to CapeOX , confirming the initial PFS analysis .
CONCLUSIONS	Therefore , the SOX regimen could be an alternative first-line doublet chemotherapy strategy for patients with metastatic colorectal cancer .
BACKGROUND	NCT00677443 and May 12 2008 .

###26055848
OBJECTIVE	Report long-term outcomes of the NOURISH randomized controlled trial ( RCT ) , which evaluated a universal intervention commencing in infancy to provide anticipatory guidance to first-time mothers on `` protective '' complementary feeding practices that were hypothesized to reduce childhood obesity risk .
METHODS	The NOURISH RCT enrolled 698 mothers ( mean age 30.1 years , SD = 5.3 ) with healthy term infants ( 51 % female ) .
METHODS	Mothers were randomly allocated to usual care or to attend two 6-session , 12-week group education modules .
METHODS	Outcomes were assessed 5 times : baseline ( infants 4.3 months ) ; 6 months after module 1 ( infants 14 months ) ; 6 months after module 2 ( infants 2 years ) and at 3.5 and 5 years of age .
METHODS	Maternal feeding practices were self-reported using validated questionnaires .
METHODS	BMI Z-score was calculated from measured child height and weight .
METHODS	Linear mixed models evaluated intervention ( group ) effect across time .
RESULTS	Retention at age 5 years was 61 % .
RESULTS	Across ages 2 to 5 years , intervention mothers reported less frequent use of nonresponsive feeding practices on 6 of 9 scales .
RESULTS	At 5 years , they also reported more appropriate responses to food refusal on 7 of 12 items ( Ps .05 ) .
RESULTS	No statistically significant group effect was noted for anthropometric outcomes ( BMI Z-score : P = .06 ) or the prevalence of overweight/obesity ( control 13.3 % vs intervention 11.4 % , P = .66 ) .
CONCLUSIONS	Anticipatory guidance on complementary feeding resulted in first-time mothers reporting increased use of protective feeding practices .
CONCLUSIONS	These intervention effects were sustained up to 5 years of age and were paralleled by a nonsignificant trend for lower child BMI Z-scores at all postintervention assessment points .

###25344064
BACKGROUND	Dantrolene is neuroprotective in animal models and may attenuate cerebral vasospasm ( cVSP ) in human aneurysmal subarachnoid haemorrhage ( aSAH ) .
BACKGROUND	We evaluated safety , feasibility and tolerability of intravenous dantrolene ( IV-D ) in patients with aSAH .
METHODS	In this single-centre , randomised , double blind , placebo-controlled trial , 31 patients with aSAH were randomised to IV-D 1.25 mg every 6h for 7days ( n = 16 ) or equiosmolar free water/5 % mannitol ( placebo ; n = 15 ) .
METHODS	Primary safety end points were incidence of hyponatraemia ( sNa132mmol/L ) and liver toxicity ( proportion of patients alanine transaminase , aspartate aminotransferase and AlkPhos > 5 upper-limit-of-normal ) .
METHODS	Secondary end points included tolerability , systemic hypotension and intracranial hypertension .
METHODS	Efficacy was explored for clinical/radiological cVSP , delayed cerebral ischaemia ( DCI ) , and 3-month functional outcomes .
METHODS	Quantitative analyses of angiograms and daily transcranial Doppler ( TCD ) were performed .
RESULTS	Between IV-D versus placebo , no differences were observed in the primary outcomes ( hyponatremia 44 % vs 67 % ( p = 0.29 ) ; liver toxicity 6 % vs 0 % ( p = 1.0 ) ) .
RESULTS	Three patients in the IV-D versus two in the placebo group had severe adverse events possibly attributable to infusion and reached stop criteria : one IV-D patient developed liver toxicity ; two patients in each group developed brain oedema requiring osmotherapy .
RESULTS	The majority of adverse events were not related to infusion ( 17 vs 5 ( RR 2.2 ; 95 % CI 0.7 to 6.7 ; p = 0.16 ) in IV-D vs placebo ) .
RESULTS	No differences in any categorical cVSP outcomes , DCI , 3-month outcomes or quantitative angiogram and TCD analyses were seen in this small safety trial not powered to detect efficacy .
CONCLUSIONS	In this small trial , IV-D after aSAH was feasible , tolerable and safe .
BACKGROUND	http://clinicaltrials.gov NCT01024972 .

###25140995
OBJECTIVE	Antithyroid drug therapy is one of the main medical treatments for Graves ' disease .
OBJECTIVE	There have been conflicting reports as to whether the addition of exogenous L-thyroxine improves remission rates more than antithyroid drugs alone .
OBJECTIVE	This randomized , controlled and prospective clinical trial was undertaken to investigate the long-term outcome of methimazole treatment with or without exogenous L-thyroxine in Chinese patients .
METHODS	145 patients with Graves ' disease were randomly divided into 3 groups and all patients initially received 30mg of methimazole daily for at least 1 month and then followed the titration - regimen with or without L-thyroxine : group 1 ( 30mg20mg15mg10mg5mg ) ; group 2 ( 30mg20mg15mg10mg + L-thyroxine5mg + L-thyroxine ) ; group 3 ( 30mg20mg15mg10mg + L-thyroxine5mg + L-thyroxine2 .5 mg + L-thyroxine ) .
METHODS	The drug therapy was discontinued after 5 months of the final dose .
RESULTS	16 out of 46 patients in group 1 ( 34.8 % ) , 12 out of 47 in group 2 ( 25.5 % ) and 16 out of 52 in group 3 ( 30.8 % ) had a recurrence of Graves ' disease within 6-year follow-up after drug withdrawal .
RESULTS	Survival Analysis showed no significant differences in the remission rates between any 2 groups , despite the remission rates in group 2 and 3 were slightly higher than that in group 1 .
CONCLUSIONS	The addition of L-thyroxine to methimazole treatment in patients with Graves ' disease neither improves nor prevents the remission or recurrence of Graves ' disease in China .

###24725238
BACKGROUND	Effective treatment for hepatitis C virus ( HCV ) genotype 1 infection in patients who have not had a sustained virologic response to prior interferon-based therapy represents an unmet medical need .
METHODS	We conducted a phase 3 , randomized , open-label study involving patients infected with HCV genotype 1 who had not had a sustained virologic response after treatment with peginterferon and ribavirin , with or without a protease inhibitor .
METHODS	Patients were randomly assigned to receive the NS5A inhibitor ledipasvir and the nucleotide polymerase inhibitor sofosbuvir in a once-daily , fixed-dose combination tablet for 12 weeks , ledipasvir-sofosbuvir plus ribavirin for 12 weeks , ledipasvir-sofosbuvir for 24 weeks , or ledipasvir-sofosbuvir plus ribavirin for 24 weeks .
METHODS	The primary end point was a sustained virologic response at 12 weeks after the end of therapy .
RESULTS	Among the 440 patients who underwent randomization and were treated , 20 % had cirrhosis and 79 % had HCV genotype 1a infection .
RESULTS	The rates of sustained virologic response were high in all treatment groups : 94 % ( 95 % confidence interval [ CI ] , 87 to 97 ) in the group that received 12 weeks of ledipasvir-sofosbuvir ; 96 % ( 95 % CI , 91 to 99 ) in the group that received 12 weeks of ledipasvir-sofosbuvir and ribavirin ; 99 % ( 95 % CI , 95 to 100 ) in the group that received 24 weeks of ledipasvir-sofosbuvir ; and 99 % ( 95 % CI , 95 to 100 ) in the group that received 24 weeks of ledipasvir-sofosbuvir and ribavirin .
RESULTS	No patient discontinued treatment owing to an adverse event .
RESULTS	The most common adverse events were fatigue , headache , and nausea .
CONCLUSIONS	Treatment with a once-daily , single-tablet regimen of ledipasvir and sofosbuvir resulted in high rates of sustained virologic response among patients with HCV genotype 1 infection who had not had a sustained virologic response to prior interferon-based treatment .
CONCLUSIONS	( Funded by Gilead Sciences ; ION-2 ClinicalTrials.gov number , NCT01768286 . )

###24321716
OBJECTIVE	We conducted a qualitative investigation of patients with type 2 diabetes to determine their perceived facilitators and barriers to exercise at multiple time points while enrolled in a randomized exercise trial including aerobic , resistance or combined exercise .
OBJECTIVE	We explored differences in these themes over time , between intervention groups and by adherence level after intervention .
METHODS	Interviews were conducted by telephone at 3 weeks ( run-in period ) , and at 3 ( midintervention ) , 6 ( end of intervention ) and 9 months ( maintenance ) after enrollment to assess factors that facilitated and hampered adherence to the exercise program .
METHODS	Audiotapes were transcribed verbatim and subjected to content analysis .
RESULTS	Participants ( n = 28 ) with type 2 diabetes engaged in the interviews .
RESULTS	Social support from family and the trainer , future health benefits , a sense of well-being and perceived fitness improvements were exercise facilitators .
RESULTS	Experiencing illness or injury , work commitments and inclement weather were highlighted barriers .
RESULTS	A sense of well-being , fitness improvements and enjoyment frequently were expressed by participants assigned to the combined and resistance exercise conditions .
RESULTS	Participants who maintained prescribed exercise levels tended to be engaged in resistance exercise , and spoke of support from their personal trainers , the importance of strategies and enjoyment more frequently than those who did not maintain their exercise level .
RESULTS	Exercise maintainers also cited more facilitators ; no differences were found for barriers .
CONCLUSIONS	Patients with type 2 diabetes require social support , including continued contact with exercise specialists .
CONCLUSIONS	Patients need assistance with motivational enhancement and strategies to increase facilitators to maintain exercise behaviour .
CONCLUSIONS	Incorporating resistance exercise improves well-being and enjoyment-2 important factors linked to exercise maintenance .

###24906587
BACKGROUND	Danshen ( Salvia miltiorrhiza ) and Gegen ( Radix puerariae ) ( D&G ) are two herbs frequently used for the treatment of angina and other cardiac symptoms in Chinese materia medica .
BACKGROUND	Recent studies have demonstrated their cardio-protective and anti-atherosclerosis effects .
BACKGROUND	Earlier we have conducted two clinical trials in 2004 and 2007 which demonstrated such effects in extremely high risk patients .
OBJECTIVE	The aim of the study was to demonstrate the safety and effectiveness of D&G in the prevention of atherosclerosis in postmenopausal women with early hypercholesterolemia .
METHODS	The study was designed as a randomized , double-blinded , placebo-controlled trial with a 12-month treatment period .
METHODS	A population based sample of 165 postmenopausal women aged 47-65 were included in the trial .
METHODS	Only women who experienced menopause for more than 12 months were recruited .
METHODS	The eligible subjects were randomized to take the D&G preparation ( two capsules ) , or image-identical placebo capsules ( two capsules ) daily , in a double-blind and parallel fashion for 12 month .
METHODS	The postmenopausal women with mild hypercholesterolemia ( mean age 56.5 4.1 of treatment group and 56.0 3.8 years of placebo group ) were randomized to the D&G group or placebo group for trial treatment .
METHODS	Carotid intima-media thickness ( IMT ) was used as the surrogate marker and was measured using high resolution ultrasound .
METHODS	Lipid profile was also tested .
RESULTS	Baseline characteristics were comparable between the two groups .
RESULTS	After 12 months , there were no significant changes in the blood pressures and general biochemical profiles in both groups , however , there was a remarkable decrease in serum low density lipoprotein ( LDL ) cholesterol ( -6.92 % ) and total cholesterol ( TC ) ( -5.85 % ) in the D&G group compared with the placebo group ( -3.21 % and -3.42 % ) when compared with the baseline .
RESULTS	The carotid intima-media thickness ( IMT ) decreased 1.52 % from baseline in the D&G group ( p < 0.004 ) but the decrease was only 1.13 % in the placebo treatment group ( p = 0.009 ) after 12 months treatment .
RESULTS	Twelve adverse events were reported ( six in placebo group and six in D&G group ) but none of them was directly relevant to the study herbal preparation .
CONCLUSIONS	Postmenopausal women with early hypercholesterolemia tolerated D&G well .
CONCLUSIONS	D&G improved the carotid intima thickness , lowered LDL and total cholesterol .
CONCLUSIONS	D&G therefore can be recommended for the prevention of atherosclerosis in postmenopausal women with hypercholesterolemia .

###24840857
OBJECTIVE	To investigate the effect of creatine ( CR ) supplementation on the acute interference induced by aerobic exercise on subsequent maximum dynamic strength ( 1RM ) and strength endurance ( SE , total number of repetitions ) performance .
METHODS	Thirty-two recreationally strength-trained men were submitted to a graded exercise test to determine maximal oxygen consumption ( VO2max : 41.56 5.24 ml kg ( -1 ) min ( -1 ) ) , anaerobic threshold velocity ( ATv : 8.3 1.18 km h ( -1 ) ) , and baseline performance ( control ) on the 1RM and SE ( 4 80 % 1RM to failure ) tests .
METHODS	After the control tests , participants were randomly assigned to either a CR ( 20 g day ( -1 ) for 7 days followed by 5 g day ( -1 ) throughout the study ) or a placebo ( PL-dextrose ) group , and then completed 4 experimental sessions , consisting of a 5-km run on a treadmill either continuously ( 90 % ATv ) or intermittently ( 1:1 min at vVO2max ) followed by either a leg - or bench-press SE/1RM test .
RESULTS	CR was able to maintain the leg-press SE performance after the intermittent aerobic exercise when compared with C ( p > 0.05 ) .
RESULTS	On the other hand , the PL group showed a significant decrease in leg-press SE ( p 0.05 ) .
RESULTS	CR supplementation significantly increased bench-press SE after both aerobic exercise modes , while the bench-press SE was not affected by either mode of aerobic exercise in the PL group .
RESULTS	Although small increases in 1RM were observed after either continuous ( bench press and leg press ) or intermittent ( bench press ) aerobic exercise in the CR group , they were within the range of variability of the measurement .
RESULTS	The PL group only maintained their 1RM .
CONCLUSIONS	In conclusion , the acute interference effect on strength performance observed in concurrent exercise may be counteracted by CR supplementation .

###24435788
BACKGROUND	Nasogastric rehydration therapy ( NGRT ) is the recommended therapy in moderately dehydrated children with gastroenteritis and refusal to drink , since it is supposed to be as effective if not better than intravenous rehydration therapy ( IVRT ) .
BACKGROUND	However , in clinical practice IVRT is often favored .
BACKGROUND	We conducted a clinical trial to determine whether IVRT is not inferior to NGRT .
METHODS	Children 3 months to 6 years of age with moderate dehydration and refusal to drink secondary to gastroenteritis were recruited .
METHODS	After clinical assessment of the degree of dehydration , patients were assigned randomly to receive either IVRT or NGRT over 6h on the hospital ward .
RESULTS	Recruitment did not yield the estimated number of patients .
RESULTS	Mainly , non-enrollment was due to failure to obtain parental consent because IVRT was expected .
RESULTS	97 patients were enrolled in the study , 46 were randomized to NGRT and 51 to IVRT .
RESULTS	There was no difference between IVRT and NGRT groups concerning length of hospital stay ( 2.21.1 days vs. 2.41.1 days ) , success of rehydration ( 78 vs. 76 % ) and adverse events .
CONCLUSIONS	Since we had to terminate the study ahead of schedule due to a low recruiting rate , our results are not reliable .
CONCLUSIONS	However , data from the literature shows that the widespread described superiority of NGRT over IVRT is seriously influenced by studies from developing countries questioning the applicability of the results to a setting available in high-income countries nowadays .
CONCLUSIONS	Our study demonstrates the difficulties performing such a study in a high-income country to come to an objective and clearly evident final conclusion .

###24968788
OBJECTIVE	The aim of this study was to compare radiological results of total knee arthroplasties ( TKAs ) performed with patient-specific computed tomography ( CT ) - based instrumentation and conventional technique .
OBJECTIVE	The main study hypothesis was that CT-based patient-specific instrumentation ( PSI ) increases the accuracy of TKA .
METHODS	A prospective , randomized controlled trial was carried out between January and December 2011 .
METHODS	A group of 112 patients who met the inclusion and exclusion criteria were enrolled in this study and randomly assigned to an experimental or control group .
METHODS	The experimental group comprised 52 patients operated on with the aid of the Signature CT-based implant positioning system .
METHODS	The control group consisted of 60 patients operated on using conventional instrumentation .
METHODS	The radiographic evaluation of implant positioning and overall coronal alignment was performed 12 months after the surgery by using standing anteroposterior radiographs of the entire lower limb and standard lateral radiographs .
RESULTS	Of the 112 patients initially enrolled for the study , 95 were included in the subsequent analyses .
RESULTS	There were no statistically significant differences between groups in respect to coronal and sagittal component positioning and overall coronal alignment , except for frontal tibial component positioning .
RESULTS	For this parameter , better results were obtained in the control group , with borderline statistical significance .
CONCLUSIONS	Our study did not reveal superiority of the CT-based PSI system over conventional instrumentation .
CONCLUSIONS	Further high-quality investigations of patient-specific systems are absolutely indispensable to assess their utility for TKA .
CONCLUSIONS	In our opinion , the surgeon applying PSI technology is required to have advanced knowledge and considerable experience with the conventional method .

###25037199
BACKGROUND	Previous studies on the prognostic value of clinical and MRI parameters for the time to return to play ( TTRTP ) in acute hamstring injuries showed only limited to moderate evidence for the various investigated parameters .
BACKGROUND	Some studies had multiple methodological limitations , including retrospective designs and the use of univariate analysis only .
BACKGROUND	The aim of this study was to assess the prognostic value of clinical and MRI parameters for TTRTP using multivariate analysis .
METHODS	28 clinical and MRI parameters were prospectively investigated for an association with TTRTP in 80 non-professional athletes with MRI positive hamstring injuries undergoing a standardised rehabilitation programme .
METHODS	The association between possible prognostic parameters and TTRTP was assessed with a multivariate linear regression model .
METHODS	Parameters that had a p value < 0.2 on univariate testing were included in this model .
RESULTS	74 athletes were available for analysis .
RESULTS	A total of nine variables met the criteria for the multivariate analysis : intensity of sports , level of sports , self-predicted TTRTP by the athlete , length of discomfort on palpation , deficit in passive straight leg raise , pain score on isometric knee flexion , isometric knee flexion strength deficit and distance of the proximal pole of the MRI hyperintensity to the tuber ischiadicum .
RESULTS	Of these , only self-predicted TTRTP by the athlete and a passive straight leg raise deficit remained significantly associated with TTRTP after stepwise logistic regression .
CONCLUSIONS	The clinical parameters self-predicted TTRTP and passive straight leg raise deficit are independently associated with the TTRTP .
CONCLUSIONS	MRI parameters in grade 1 and 2 hamstring injuries , as described in the literature , are not associated with TTRTP .
CONCLUSIONS	For clinical practice , prognosis of the TTRTP in these injuries should better be based on clinical parameters .

###25390281
BACKGROUND	Effective O2 delivery and accurate end-tidal CO2 ( ETCO2 ) sampling are essential features of nasal cannulae ( NCs ) in patients with compromised respiratory status .
BACKGROUND	We studied 4 NC designs : bifurcated nasal prongs ( NPs ) with O2 delivery and CO2 sensing in both NPs ( Hudson ) , separate O2/CO2 NPs ( Salter ) , and CO2 sensing in NPs with cloud O2 delivery outside the NPs via multi vents ( Oridion ) and dual vents ( Medline ) .
BACKGROUND	We hypothesized that design differences between NCs would influence O2 delivery and ETCO2 detection .
METHODS	Forty-five healthy volunteers , 18 to 35 years , participated in an unrestricted , randomized block design , each subject serving as their own control in a 4-period crossover study design of 4 NCs during one session .
METHODS	Monitoring included electrocardiogram , posterior pharynx O2 sampling from a Hauge Airway ( Sharn Anesthesia Products , Tampa , FL ) , and NC ETCO2 .
METHODS	In 11 volunteers , radial artery blood was sampled from a catheter for partial pressures of O2 and carbon dioxide ( PaO2 and PaCO2 ) determination .
METHODS	Per randomization , each NC was positioned , and data were collected over 2 minutes ( ETCO2 , pharyngeal O2 , PaO2 , and PaCO2 ) during room air and during O2 fresh gas flows ( FGFs ) of 2 , 4 , and 6 Lpm .
METHODS	Statistical analyses were performed with SAS Analytics Pro , Version 9.3 , and JMP Statistical Software , Version 11 ( SAS Institute Inc. , Cary , NC ) , significance at P < 0.05 .
RESULTS	Blood gas analyses indicated PaCO2 during steady state at each experimental time period remained unchanged from physiologic baseline .
RESULTS	PaO2 did not differ between NC devices at baseline or 2 Lpm O2 .
RESULTS	The PaO2 at 4 Lpm from the separate NPs and bifurcated NCs was significantly higher than the multi-vented NC .
RESULTS	Pharyngeal O2 with the NC with separate NPs was significantly higher than multivented and dual-vented cloud delivery NCs at 2 , 4 , and 6 Lpm FGF .
RESULTS	Pharyngeal O2 with the NC with bifurcated NPs was significantly higher than the multi-vented NC at 2 Lpm , and higher than cloud delivery NCs at 4 and 6 Lpm FGF .
RESULTS	ETCO2 was significantly lower with the NC with bifurcated NPs compared to the other 3 NCs , consistent with errant CO2 tracings at higher FGF .
CONCLUSIONS	NCs provide supplemental inspired O2 concentrations for patients with impaired pulmonary function .
CONCLUSIONS	Accurate measures of ETCO2 are helpful in assessing respiratory rate and determining whether CO2 retention is occurring from hypoventilation .
CONCLUSIONS	These findings suggest the NC with separate NPs was the most effective in delivering O2 and the most consistent at providing reliable CO2 waveforms at higher FGFs .

###25330327
BACKGROUND	Protein supplementation has been shown to reduce the increases in intrahepatic triglyceride ( IHTG ) content induced by acute hypercaloric high-fat and high-fructose diets in humans .
OBJECTIVE	To assess the effect of a 12-wk iso-energetic high protein-low carbohydrate ( HPLC ) diet compared with an iso-energetic high carbohydrate-low protein ( HCLP ) diet on IHTG content in healthy non-obese subjects , at a constant body weight .
METHODS	Seven men and nine women [ mean SD age : 24 5 y ; BMI : 22.9 2.1 kg/m2 ] were randomly allocated to a HPLC [ 30/35/35 % of energy ( En % ) from protein/carbohydrate/fat ] or a HCLP ( 5/60/35 En % ) diet by stratification on sex , age and BMI .
METHODS	Dietary guidelines were prescribed based on individual daily energy requirements .
METHODS	IHTG content was measured by 1H-magnetic resonance spectroscopy before and after the dietary intervention .
RESULTS	IHTG content changed in different directions with the HPLC ( CH2H2O : 0.23 0.17 to 0.20 0.10 ; IHTG % : 0.25 0.20 % to 0.22 0.11 % ) compared with the HCLP diet ( CH2H2O : 0.34 0.20 vs. 0.38 0.21 ; IHTG % : 0.38 0.22 % vs. 0.43 0.24 % ) , which resulted in a lower IHTG content in the HPLC compared with the HCLP diet group after 12 weeks , which almost reached statistical significance ( P = 0.055 ) .
CONCLUSIONS	A HPLC vs. a HCLP diet has the potential to preserve vs. enlarge IHTG content in healthy non-obese subjects at a constant body weight .
BACKGROUND	Clinicaltrials.gov NCT01551238 .

###25569028
OBJECTIVE	We compared the clinical efficacy of barium therapy and conservative therapy in preventing recurrence in patients with diverticular bleeding .
BACKGROUND	Previous case reports have indicated that barium impaction therapy provides initial hemostasis for diverticular bleeding and prevention against rebleeding .
METHODS	After spontaneous cessation of bleeding , patients were randomly assigned to conservative treatment ( n = 27 ) or high-dose barium impaction therapy ( n = 27 ) .
METHODS	Patients were followed up for 1 year after enrollment of the last patient .
METHODS	The main outcome measure was rebleeding .
RESULTS	Median follow-up period was 584.5 days .
RESULTS	The probability of rebleeding at 30-day , 180-day , 1-year , and 2-year follow-up in all patients was 3.7 % , 14.8 % , 28.4 % , and 32.7 % , respectively .
RESULTS	By group , probability at 1 year was 42.5 % in the conservative group and 14.8 % in the barium group ( log-rank test , P = 0.04 ) .
RESULTS	After adjustment for a history of hypertension , the hazard ratio of rebleeding in the barium group was 0.34 ( 95 % confidence interval , 0.12-0 .98 ) .
RESULTS	No complications or laboratory abnormalities due to barium therapy were observed .
RESULTS	Compared with the conservative group , the barium group had significantly ( P < 0.05 ) fewer hospitalizations per patient ( 1.7 vs 1.2 ) , units of blood transfused ( 1.9 vs 0.7 ) , colonoscopies ( 1.4 times vs 1.1 times ) , and hospital stay days ( 15 days vs 11 days ) during the follow-up period .
RESULTS	No patients died and none required angiographic or surgical procedures in either group .
CONCLUSIONS	High-dose barium impaction therapy was effective in the long-term prevention of recurrent bleeding , and reduced the frequency of rehospitalization and need for blood transfusion and colonoscopic examination .
CONCLUSIONS	ClinicalTrials.gov Identifier , UMIN 000002832 .

###25066659
BACKGROUND	Fiber intakes in developed countries are generally below those recommended by relevant authorities .
BACKGROUND	Given that many people consume fiber-depleted refined-grain products , adding functional fiber will help to increase fiber intakes .
BACKGROUND	The objective of the study was to determine metabolic and sensory effects of adding fiber to bread .
METHODS	A double-blind pair of randomized crossover trials with a two-week washout in which two fiber-containing breads were compared with control bread .
METHODS	The functional fiber ( fruit fiber and FibreMax ) was added to yield 10 g fiber per serve ( two slices ) .
METHODS	Eighty participants ( n = 37 fruit fiber and n = 43 FibreMax ) consumed one serve of bread ( fiber or control ) followed three hours later by a pasta meal consumed ad libitum .
METHODS	Outcome measures included glycemia , satiety , palatability , gastrointestinal wellbeing , visual appeal and subsequent energy intake of the pasta meal .
METHODS	Multivariate regression was undertaken to test for differences between treatment and control for blood glucose , satiety , and cumulative energy intake .
METHODS	Satiety responses were also compared by splitting the data into an immediate response after eating ( 0-30 min ) and a return to hunger analysis ( 30-180 min ) .
METHODS	A Wilcoxon sign rank test was used for the first component ( 0-30 min ) and Wilcoxon matched-pairs signed-rank test for the second component ( 30-180 min ) .
METHODS	Between treatment differences for gastrointestinal wellbeing were tested using Pearson 's chi-square test or Fisher 's exact test .
RESULTS	Consumption of the fruit fiber bread reduced postprandial glycemia by 35 % ( 95 % CI 13 to 51 ; P = 0.004 ) and cumulative energy intake by 368 kJ ( 95 % CI 163 to 531 ; P = 0.001 ) .
RESULTS	There was little influence on satiety and the bread was rated as having poor taste and smell whilst generating feelings of nausea in some participants .
RESULTS	FibreMax enriched bread reduced glycemia by 43 % ( 95 % CI 17 to 61 ; P = 0.004 ) without influence on energy intake or satiety .
RESULTS	Apart from a lower visual appeal , the FibreMax bread was palatable .
RESULTS	Neither bread caused gastrointestinal discomfort related to flatulence or bloating .
CONCLUSIONS	Enriching bread with 10 g of functional fiber per serve is feasible although reformulation is needed to create not only an acceptable bread , but a desirable product .

###25406730
OBJECTIVE	To investigate the efficacy and tolerability of albiglutide , a weekly glucagon-like peptide-1 receptor agonist , when added to metformin and glimepiride in a triple therapy regimen in people with type 2 diabetes mellitus .
METHODS	This was a 156-week , randomized , double-blind , parallel-group , multicentre study .
METHODS	In the present paper we describe the primary results , namely those at 52weeks .
METHODS	Adult participants ( n = 685 ) were randomly assigned to albiglutide ( 30mg/week ) , pioglitazone ( 30mg/day ) or placebo .
METHODS	If needed , blinded uptitration of albiglutide ( to 50mg/week ) and pioglitazone ( to 45mg/day ) was allowed .
METHODS	The participant 's current dose of metformin ( > 1500mg/day ) was maintained throughout .
METHODS	The glimepiride dose ( 4mg/day ) , standardized before randomization , could be decreased if persistent hypoglycaemia occurred .
RESULTS	The week 52 model-adjusted difference in change of glycated haemoglobin ( primary endpoint ) for albiglutide versus placebo was -0.87 [ 95 % confidence interval ( CI ) -1.07 , -0.68 ] % - units ( p < 0.001 ) , and for albiglutide versus pioglitazone it was 0.25 ( 95 % CI 0.10 , 0.40 ) % - units ; therefore , not non-inferior .
RESULTS	In the albiglutide group only , fasting plasma glucose reduced rapidly in the first 2weeks .
RESULTS	Confirmed hypoglycaemia occurred in 14 % of participants on albiglutide , 25 % on pioglitazone and 14 % on placebo .
RESULTS	The mean ( standard error ) weight change was -0.42 ( 0.2 ) kg with albiglutide , +4.4 ( 0.2 ) kg ( p < 0.001 ) with pioglitazone , and -0.40 ( 0.4 ) kg with placebo and serious adverse events occurred in 6.3 , 9.0 and 6.1 % of participants in the respective groups .
RESULTS	Injection site reactions occurred in 13 % of participants on albiglutide and resulted in treatment discontinuation for four participants ( 1.4 % ) .
CONCLUSIONS	Albiglutide , as part of triple therapy , provided effective glucose-lowering and was generally well tolerated .

###24334242
BACKGROUND	Irritable bowel syndrome with diarrhoea ( IBS-D ) is particularly debilitating due to urgency and episodic incontinence .
BACKGROUND	Some 5-hydroxytryptamine 3 ( 5-HT3 ) receptor antagonists ( 5-HT3RAs ) have proven effective but have serious side effects .
BACKGROUND	Ondansetron , also a 5-HT3RA , has been widely used as an antiemetic with an excellent safety record for over two decades .
BACKGROUND	Our aim was to assess its effectiveness in IBS-D .
METHODS	120 patients meeting Rome III criteria for IBS-D entered a randomised , double-blind , placebo-controlled crossover study of 5weeks of ondansetron 4mg versus placebo with dose titration allowed , up to two tablets three times daily in the first 3weeks .
METHODS	Patients completed daily diaries documenting stool consistency using the Bristol Stool Form score .
METHODS	Gut transit was measured in the last week of each treatment .
METHODS	The primary endpoint was average stool consistency in the last 2weeks of treatment .
RESULTS	Ondansetron significantly improved stool consistency ( mean difference in stool form between ondansetron and placebo -0.9 , 95 % CI -1.1 to -0.6 , p < 0.001 ) .
RESULTS	Compared with placebo , patients on ondansetron experienced fewer days with urgency ( p < 0.001 ) , lower urgency scores ( p < 0.001 ) , reduced frequency of defaecation ( p = 0.002 ) and less bloating ( p = 0.002 ) , although pain scores did not change significantly .
RESULTS	IBS symptom severity score fell more with ondansetron than placebo ( 839.8 vs 379.7 , p = 0.001 ) .
RESULTS	65 % reported adequate relief with ondansetron but not placebo compared with 14 % reporting relief with placebo but not ondansetron , relative risk 4.7 , 95 % CI 2.6 to 8.5 , p < 0.001 .
CONCLUSIONS	Ondansetron relieves some of the most intrusive symptoms of IBS-D , namely loose stools , frequency and urgency .

###25438964
OBJECTIVE	Because many sports concussions happen during school-sponsored sports events , most state concussion laws specifically hold schools accountable for coach training and effective concussion management practices .
OBJECTIVE	Brain 101 : The Concussion Playbook is a Web-based intervention that includes training in sports concussion for each member of the school community , presents guidelines on creating a concussion management team , and includes strategies for supporting students in the classroom .
METHODS	The group randomized controlled trial examined the efficacy of Brain 101 in managing sports concussion .
METHODS	Participating high schools ( N = 25 ) were randomly assigned to the Brain 101 intervention or control .
METHODS	Fall athletes and their parents completed online training , and Brain 101 school administrators were directed to create concussion management policy and procedures .
RESULTS	Student athletes and parents at Brain 101 schools significantly outperformed those at control schools on sports concussion knowledge , knowledge application , and behavioral intention to implement effective concussion management practices .
RESULTS	Students who had concussions in Brain 101 schools received more varied academic accommodations than students in control schools .
CONCLUSIONS	Brain 101 can help schools create a comprehensive schoolwide concussion management program .
CONCLUSIONS	It requires minimal expenditures and offers engaging and effective education for teachers , coaches , parents , and students .

###24227660
OBJECTIVE	To evaluate the effects of canagliflozin , a sodium glucose co-transporter 2 inhibitor , on body weight in overweight and obese subjects ( body mass index [ BMI ] 27 and < 50 kg/m ( 2 ) ) .
METHODS	This 12-week , Phase 2b , randomized , double-blind study enrolled 376 subjects without diabetes mellitus who received canagliflozin 50 , 100 , or 300 mg or placebo once daily .
METHODS	The primary endpoint was the percent change in body weight from baseline through Week 12 .
RESULTS	Canagliflozin increased urinary glucose excretion in a dose-dependent manner and produced statistically significant reductions in body weight compared with placebo ( least squares mean percent changes from baseline of -2.2 % , -2.9 % , -2.7 % , and -1.3 % with canagliflozin 50 , 100 , and 300 mg and placebo ; P < 0.05 for all comparisons ) .
RESULTS	Overall adverse event ( AE ) rates were similar across groups .
RESULTS	Canagliflozin was associated with higher rates of genital mycotic infections in women , which were generally mild and led to few study discontinuations .
RESULTS	Osmotic diuresis-related AE rates were low and similar across groups .
CONCLUSIONS	In overweight and obese subjects without diabetes mellitus , canagliflozin significantly reduced body weight compared with placebo and was generally well tolerated .

###24299565
BACKGROUND	There have been no data on sublingual immunotherapy ( SLIT ) in Brazilian patients sensitized to house dust mites .
BACKGROUND	This study aimed to evaluate the mucosal/systemic antibody response changes and clinical efficacy after SLIT using Dermatophagoides pteronyssinus ( Dpt ) allergens with or without bacterial extracts in mite-allergic Brazilian children .
METHODS	Patients with allergic rhinitis and asthma were selected for a double-blind , placebo-controlled trial randomized to three groups : DPT ( Dpt extract , n = 34 ) , DPT+MRB ( Dpt plus mixed respiratory bacterial extracts , n = 36 ) , and Placebo ( n = 32 ) .
METHODS	Total symptom and medication scores for rhinitis/asthma , skin prick test ( SPT ) to Dpt , and measurements of Dpt - , Der p 1 - , Der p 2-specific serum IgE , IgG4 , IgG1 , and specific salivary IgA were evaluated at baseline and after 12 and 18 months of treatment .
RESULTS	A significant long-term decline in total symptom/medication scores was observed only in active groups ( DTP and DPT+MRB ) .
RESULTS	There was no significant change in SPT results in all groups .
RESULTS	SLIT using Dpt allergen alone induced increased levels of serum IgG4 to Dpt , Der p 1 , and Der p 2 , serum IgG1 and salivary IgA to Dpt and Der p 1 .
RESULTS	SLIT with Dpt plus bacterial extracts was able to decrease IgE levels , particularly to Der p 2 , to increase salivary IgA levels to Der p 1 , but had no changes on specific IgG4 and IgG1 levels .
CONCLUSIONS	All children undergoing SLIT showed clinical improvement , but a long-term reduction in symptom/medication scores with modulation of mucosal/systemic antibody responses were seen only in active groups ( DPT and DPT+MRB ) .

###24599110
OBJECTIVE	The aim of this study was to test the hypothesis that intensive glycaemic control ( INT ) and higher plasma C-peptide levels in patients with poorly controlled diabetes would be associated with better eye outcomes .
METHODS	The incidence and progression of diabetic retinopathy ( DR ) was assessed by grading seven-field stereoscopic fundus photographs at baseline and 5 years later in 858 of 1,791 participants in the Veterans Affairs Diabetes Trial ( VADT ) .
RESULTS	After adjustment for all covariates , risk of progression ( but not incidence ) of DR increased by 30 % for each 1 % increase in baseline HbA1c ( OR 1.3 ; 95 % CI 1.123 , 1.503 ; p = 0.0004 ) .
RESULTS	Neither assignment to INT nor age was independently associated with DR in the entire cohort .
RESULTS	However , INT showed a biphasic interaction with age .
RESULTS	The incidence of DR was decreased in INT participants 55 years of age ( OR 0.49 ; 95 % CI 0.24 , 1.0 ) but increased in those 70 years old ( OR 2.88 ; 95 % CI 1.0 , 8.24 ) ( p = 0.0043 ) .
RESULTS	The incidence of DR was reduced by 67.2 % with each 1 pmol/ml increment in baseline C-peptide ( OR 0.328 ; 95 % CI 0.155 , 0.7 ; p = 0.0037 ) .
RESULTS	Baseline C-peptide was also an independent inverse risk factor for the progression of DR , with a reduction of 47 % with each 1 pmol/ml increase in C-peptide ( OR 0.53 ; 95 % CI 0.305 , 0.921 ; p = 0.0244 ) .
CONCLUSIONS	Poor glucose control at baseline was associated with an increased risk of progression of DR. INT was associated with a decreased incidence of DR in younger patients but with an increased risk of DR in older patients .
CONCLUSIONS	Higher C-peptide at baseline was associated with reduced incidence and progression of DR.

###24858963
BACKGROUND	The need for long preoperative fasting has been questioned .
BACKGROUND	Recent data shows that intake of an oral carbohydrate-containing clear fluid prior to anaesthesia is safe and may have a positive impact on recovery and metabolic status and could improve glucose tolerance .
BACKGROUND	Such solutions are routinely used in adults but not children .
BACKGROUND	The aim of this study was to evaluate the safety , tolerance and influence of oral carbohydrate on selected metabolic parameters in children .
METHODS	With ethics committee approval and parental informed consent , 20 children , aged 4-17 years , ASA status I or II , scheduled for abdominal or thoracic surgery were randomised either to Group 1 - receiving a 12.6 % carbohydrate-containing drink ( 10 mL kg ( -1 ) the evening before surgery and two hours before anaesthesia ) , or the control Group 2 - fasting .
METHODS	Serum glucose and insulin concentration were measured four times : before and after anaesthesia , in the evening after surgery , and the following morning .
METHODS	IGF-1 concentration was measured once , before surgery .
METHODS	Insulin resistance was assessed by the HOMA-IR equation .
RESULTS	Oral carbohydrate solution was well tolerated and no adverse events were noted .
RESULTS	Glucose concentrations were within the normal range in both groups .
RESULTS	Insulin concentration did not show significant differences between groups , however before surgery it tended to be lower in Group 1 .
RESULTS	Insulin resistance after surgery was significantly higher in Group 2 ( 2.0 vs. 0.62 , P = 0.03 ) , also the increase in insulin resistance after operation was significant only in the control group ( P = 0.03 ) .
CONCLUSIONS	Oral carbohydrates are safe , well tolerated and do not cause any perioperative adverse events .
CONCLUSIONS	They seem to improve postoperative metabolism by decreasing insulin resistance .

###25823155
OBJECTIVE	To investigate the effects of magnesium sulphate on succinylcholine-induced fasciculation in patients during the induction of general anaesthesia .
METHODS	The double-blind randomised clinical trial was conducted in 2012 at Tohid and Besat Hospitals in Sanandaj , Iran , on patients who were candidates for surgery under general anaesthesia .
METHODS	Patients were selected and divided into two equal groups of cases and controls using block randomisation .
METHODS	The cases received magnesium sulphate , while the controls received normal saline .
METHODS	SPSS 18 was used for statistical analysis .
RESULTS	Of the 100 subjects in the study , 49 ( 49 % ) were men and 51 ( 51 % ) were women ( p < 0.072 ) .
RESULTS	The mean age of the two groups were 37.5 12.2 years and 37.7 12 years ( p < 0.9 ) .
RESULTS	There was significant difference between the two groups in terms of the degree of fasciculation and muscle fasciculation ( p < 0.001 ) .
RESULTS	The difference between potassium levels in the two groups was not significant before anaesthesia ( p > 0.05 ) , but it was significant after anaesthesia ( p < 0.001 ) .
CONCLUSIONS	Magnesium sulphate can prevent and reduce the degree of fasciculation after anaesthesia .
CONCLUSIONS	Therefore it can be used to prevent fasciculation .

###25287298
BACKGROUND	Schools provide a natural context to promote children 's mental health .
BACKGROUND	However , there is a need for more evidence-based , high quality school intervention programs combined with an accurate evaluation of their general effectiveness and effectiveness of specific intervention methods .
BACKGROUND	The aim of this paper is to present a study protocol of a cluster randomized controlled trial evaluating the `` Together at School '' intervention program .
BACKGROUND	The intervention program is designed to promote social-emotional skills and mental health by utilizing whole-school approach and focuses on classroom curriculum , work environment of school staff , and parent-teacher collaboration methods .
METHODS	The evaluation study examines the effects of the intervention on children 's socio-emotional skills and mental health in a cluster randomized controlled trial design with 1 ) an intervention group and 2 ) an active control group .
METHODS	Altogether 79 primary school participated at baseline .
METHODS	A multi-informant setting involves the children themselves , their parents , and teachers .
METHODS	The primary outcomes are measured using parent and teacher ratings of children 's socio-emotional skills and psychological problems measured by the Strengths and Difficulties Questionnaire and the Multisource Assessment of Social Competence Scale .
METHODS	Secondary outcomes for the children include emotional understanding , altruistic behavior , and executive functions ( e.g. working memory , planning , and inhibition ) .
METHODS	Secondary outcomes for the teachers include ratings of e.g. school environment , teaching style and well-being .
METHODS	Secondary outcomes for both teachers and parents include e.g. emotional self-efficacy , child rearing practices , and teacher-parent collaboration .
METHODS	The data was collected at baseline ( autumn 2013 ) , 6 months after baseline , and will be collected also 18 months after baseline from the same participants .
CONCLUSIONS	This study protocol outlines a trial which aims to add to the current state of intervention programs by presenting and studying a contextually developed and carefully tested intervention program which is tailored to fit a national school system .
CONCLUSIONS	Identification of effective intervention elements to promote children 's mental health in early school years is crucial for optimal later development .
BACKGROUND	ClinicalTrials.gov register : NCT02178332 .

###25194168
BACKGROUND	Resuscitation is a life-saving measure usually instructed in simulation sessions .
BACKGROUND	Small-group teaching is effective .
BACKGROUND	However , feasible group sizes for resuscitation classes are unknown .
BACKGROUND	We investigated the impact of different group sizes on the outcome of resuscitation training .
METHODS	Medical students ( n = 74 ) were randomized to courses with three , five or eight participants per tutor .
METHODS	The course duration was adjusted according to the group size , so that there was a time slot of 6 minutes hands-on time for every student .
METHODS	All participants performed an objective structured clinical examination before and after training .
METHODS	The teaching sessions were videotaped and resuscitation quality was scored using a checklist while we measured the chest compression parameters with a manikin .
METHODS	In addition , we recorded hands-on-time , questions to the tutor and unrelated conversation .
RESULTS	Results are displayed as median ( IQR ) .
RESULTS	Checklist pass rates and scores were comparable between the groups of three , five and eight students per tutor in the post-test ( 93 % , 100 % and 100 % ) .
RESULTS	Groups of eight students asked fewer questions ( 0.5 ( 0.0 - 1.0 ) vs. 3.0 ( 2.0 - 4.0 ) , p < .001 ) , had less hands-on time ( 2:16 min ( 1:15 - 4:55 min ) vs. 4:07 min ( 2:54 - 5:52 min ) , p = .02 ) , conducted more unrelated conversations ( 17.05.1 and 2.91.7 , p < 0.001 ) and had lower self-assessments than groups of three students per tutor ( 7.0 ( 6.1 - 9.0 ) and 8.2 ( 7.2 - 9.0 ) , p = .03 ) .
CONCLUSIONS	Resuscitation checklist scores and pass rates after training were comparable in groups of three , five or eight medical students , although smaller groups had advantages in teaching interventions and hands-on time .
CONCLUSIONS	Our results suggest that teaching BLS skills is effective in groups up to eight medical students , but smaller groups yielded more intense teaching conditions , which might be crucial for more complex skills or less advanced students .

###25584995
OBJECTIVE	Urinary tract infection is a key issue for long-term intermittent catheterization users .
OBJECTIVE	Various catheter designs and methods have evolved to decrease the risk but the evidence remains unclear regarding whether product type improves outcomes .
OBJECTIVE	We determined whether single use hydrophilic coated catheters reduced urinary tract infections compared to multiple use polyvinylchloride catheters for children with neurogenic bladder due to spina bifida .
METHODS	This was a randomized crossover 4-center trial with 2 treatment periods of 24 weeks each , consisting of single use hydrophilic coated catheter and multiple use polyvinylchloride catheter ( washed with soap and water , and air dried after each use ) .
METHODS	Each week participants recorded symptoms and urine results ( Multistix 8SG reagent strip ) .
METHODS	Primary outcome was person-weeks of urinary tract infection , defined as positive leukocytes plus fever , flank pain , increased incontinence , malaise , or cloudy or odorous urine requiring antibiotic treatment .
METHODS	Individuals were included if they were a child or young adult with spina bifida and used intermittent catheterization as the primary method of bladder emptying .
RESULTS	Calculated sample size was 97 .
RESULTS	More than 120 patients were screened , of whom 66 were randomized and 45 completed both trial arms .
RESULTS	Mean age was 10.6 years .
RESULTS	Of the patients 21 were male and 24 were female .
RESULTS	Mean SD person-weeks of urinary tract infection was 3.42 4.67 in the single use hydrophilic coated catheter group and 2.20 3.23 in the multiple use polyvinylchloride catheter group ( p < 0.001 ) .
RESULTS	There were no statistical differences in weeks of febrile urinary tract infection or antibiotic use .
CONCLUSIONS	Results are consistent with the Cochrane Review in that single use hydrophilic coated catheters may not decrease the incidence of symptomatic urinary tract infection in community dwelling chronic intermittent catheterization users when compared to clean multiple use polyvinylchloride catheters .

###24807748
OBJECTIVE	Due to the negative impact of radiation on the patient and the surgical team during percutaneous nephrolithotomy ( PCNL ) , we aimed to evaluate success rate and complications of blind access for PCNL using lumbar notch landmark and compare with conventional fluoroscopy-guided access .
METHODS	In a clinical trial , 100 patients who were candidate for PCNL , were randomly assigned into blind group ( 1 ) and fluoroscopy-guided group ( 2 ) .
METHODS	In group 1 the lumbar notch was used to guide percutaneous access and in group 2 fluoroscopy performed after needle insertion , Amplatz placement and at the end of surgery .
METHODS	If the access failed , we would repeat puncturing up to 5 times .
METHODS	In group 2 , access was achieved using full fluoroscopy guidance .
METHODS	All patients underwent postoperative assessment including kidney-ureter-bladder X-ray and ultrasonography .
RESULTS	Both mean access time and mean operation time were statically similar in group 1 and group 2 ( 3.3 0.5 vs. 3.6 0.7 min and 35.2 4.6 vs. 38.9 4.1 min , respectively ) .
RESULTS	A successful puncture was achieved in 86 % and 94 % of the patients in groups 1 and 2 , respectively ( P = .18 ) .
RESULTS	Total success rate of procedure was 80 % and 88 % of the patients in groups 1 and 2 , respectively ( P = .27 ) .
CONCLUSIONS	According to this study , it seems that blind access is a safe and effective PCNL method , and we recommend employment of this technique by skilled endourologist in urology centers especially for patient with large hydronephrotic kidney .

###24831119
OBJECTIVE	To evaluate the effectiveness of the computerized CBT ( cCBT ) programme , MoodGYM , for the reduction in symptoms of general psychological distress ( the primary outcome ) , depression , anxiety , stress , and impaired daily functioning .
METHODS	A randomized controlled trial , with a waiting list control condition , in a routine clinical setting .
METHODS	Participants were 149 public mental health service users ( aged 18-61 [ M = 35.3 years ; SD = 10.3 ] ) waiting for interventions .
METHODS	Self-report outcome measures were administered online at baseline and post-intervention ( i.e. , after 32 days ) .
RESULTS	After high dropout rates , a post-intervention completers analysis examined 28 MoodGYM participants and 38 waiting list control participants .
RESULTS	MoodGYM was significantly more effective than the waiting list control for the reduction of symptoms of general psychological distress ( F [ 1 , 64 ] = 4.45 ; p < .05 ) and stress ( F [ 1 , 64 ] = 5.35 ; p < .05 ) but not depression , anxiety , or impaired daily functioning .
CONCLUSIONS	Due to their high associated dropout rates , self-help cCBT programmes such as MoodGYM should not be provided as front-line treatments .
CONCLUSIONS	However , as it is likely to be agreeable and beneficial to some service users , perhaps self-help cCBT should be provided as an additional treatment option .

###24469620
BACKGROUND	Single-centre series of the management of patients with ruptured abdominal aortic aneurysm ( AAA ) are usually too small to identify clinical factors that could improve patient outcomes .
METHODS	IMPROVE is a pragmatic , multicentre randomized clinical trial in which eligible patients with a clinical diagnosis of ruptured aneurysm were allocated to a strategy of endovascular aneurysm repair ( EVAR ) or to open repair .
METHODS	The influences of time and manner of hospital presentation , fluid volume status , type of anaesthesia , type of endovascular repair and time to aneurysm repair on 30-day mortality were investigated according to a prespecified plan , for the subgroup of patients with a proven diagnosis of ruptured or symptomatic AAA .
METHODS	Adjustment was made for potential confounding factors .
RESULTS	Some 558 of 613 randomized patients had a symptomatic or ruptured aneurysm : diagnostic accuracy was 910 per cent .
RESULTS	Patients randomized outside routine working hours had higher operative mortality ( adjusted odds ratio ( OR ) 147 , 95 per cent confidence interval 100 to 217 ) .
RESULTS	Mortality rates after primary and secondary presentation were similar .
RESULTS	Lowest systolic blood pressure was strongly and independently associated with 30-day mortality ( 51 per cent among those with pressure below 70 mmHg ) .
RESULTS	Patients who received EVAR under local anaesthesia alone had greatly reduced 30-day mortality compared with those who had general anaesthesia ( adjusted OR 027 , 010 to 070 ) .
CONCLUSIONS	These findings suggest that the outcome of ruptured AAA might be improved by wider use of local anaesthesia for EVAR and that a minimum blood pressure of 70 mmHg is too low a threshold for permissive hypotension .

###24517155
BACKGROUND	Conventional glucocorticoid replacement therapy fails to mimic the physiological cortisol rhythm , which may have implications for morbidity and mortality in patients with Addison 's disease .
OBJECTIVE	The objective of the study was to compare the effects of continuous sc hydrocortisone infusion ( CSHI ) with conventional oral hydrocortisone ( OHC ) replacement therapy .
METHODS	This was a prospective crossover , randomized , multicenter clinical trial comparing 3 months of treatment with thrice-daily OHC vs CSHI .
METHODS	From Norway and Sweden , 33 patients were enrolled from registries and clinics .
METHODS	All patients were assessed at baseline and after 8 and 12 weeks in each treatment arm .
METHODS	The morning ACTH level was the primary outcome measure .
METHODS	Secondary outcome measures were effects on metabolism , health-related quality of life ( HRQoL ) , sleep , and safety .
RESULTS	CSHI yielded normalization of morning ACTH and cortisol levels , and 24-hour salivary cortisol curves resembled the normal circadian variation .
RESULTS	Urinary concentrations of glucocorticoid metabolites displayed a normal pattern with CSHI but were clearly altered with OHC .
RESULTS	Several HRQoL indices in the vitality domain improved over time with CSHI .
RESULTS	No benefit was found for either treatments for any subjective ( Pittsburgh Sleep Quality Index questionnaire ) or objective ( actigraphy ) sleep parameters .
CONCLUSIONS	CSHI safely brought ACTH and cortisol toward normal circadian levels without adversely affecting glucocorticoid metabolism in the way that OHC did .
CONCLUSIONS	Positive effects on HRQoL were noted with CSHI , indicating that physiological glucocorticoid replacement therapy may be beneficial and that CSHI might become a treatment option for patients poorly controlled on conventional therapy .

###24564346
OBJECTIVE	Studies have suggested a link between diet and behavior in children with autism spectrum disorders ( ASDs ) .
OBJECTIVE	Parental reports of behavioral changes upon exposure to gluten and/or casein are common in clinical practice .
OBJECTIVE	An association between diet type , intestinal permeability ( IP ) ( ` leaky gut ' ) , and behavior has been long proposed but not substantiated .
OBJECTIVE	We explored this possible association in this trial .
METHODS	This randomized double-blind , placebo-controlled study explored the effects of gluten and milk on IP and behavior in children with ASDs over a period of 4 weeks .
METHODS	IP assessed by lactulose : mannitol ( L/M ) sugar permeability test and behavior assessed by the Aberrant Behavior Checklist and Conners Parent Rating were measured .
METHODS	Gastrointestinal symptoms in both groups were also monitored .
RESULTS	Neither the L/M ratio nor behavioral scores were different between groups exposed to gluten/dairy or placebo .
RESULTS	The changes observed were noted to be small and not clinically significant .
CONCLUSIONS	Our study although underpowered to show small differences does not support an association between dietary gluten/milk , IP , and behavioral changes in subjects with ASD .

###24733770
BACKGROUND	Optimization of systolic blood pressure and lipid levels are essential for secondary prevention after ischemic stroke , but there are substantial gaps in care , which could be addressed by nurse - or pharmacist-led care .
BACKGROUND	We compared 2 types of case management ( active prescribing by pharmacists or nurse-led screening and feedback to primary care physicians ) in addition to usual care .
METHODS	We performed a prospective randomized controlled trial involving adults with recent minor ischemic stroke or transient ischemic attack whose systolic blood pressure or lipid levels were above guideline targets .
METHODS	Participants in both groups had a monthly visit for 6 months with either a nurse or pharmacist .
METHODS	Nurses measured cardiovascular risk factors , counselled patients and faxed results to primary care physicians ( active control ) .
METHODS	Pharmacists did all of the above as well as prescribed according to treatment algorithms ( intervention ) .
RESULTS	Most of the 279 study participants ( mean age 67.6 yr , mean systolic blood pressure 134 mm Hg , mean low-density lipoprotein [ LDL ] cholesterol 3.23 mmol/L ) were already receiving treatment at baseline ( antihypertensives : 78.1 % ; statins : 84.6 % ) , but none met guideline targets ( systolic blood pressure 140 mm Hg , fasting LDL cholesterol 2.0 mmol/L ) .
RESULTS	Substantial improvements were observed in both groups after 6 months : 43.4 % of participants in the pharmacist case manager group met both systolic blood pressure and LDL guideline targets compared with 30.9 % in the nurse-led group ( 12.5 % absolute difference ; number needed to treat = 8 , p = 0.03 ) .
CONCLUSIONS	Compared with nurse-led case management ( risk factor evaluation , counselling and feedback to primary care providers ) , active case management by pharmacists substantially improved risk factor control at 6 months among patients who had experienced a stroke .
BACKGROUND	ClinicalTrials.gov , no .
BACKGROUND	NCT00931788 .

###24788320
BACKGROUND	The antibiotic rifaximin is used to treat non-constipated irritable bowel syndrome ( IBS ) .
BACKGROUND	Methane production is associated with constipation and its severity in constipation-predominant IBS ( C-IBS ) .
BACKGROUND	A previous retrospective study suggested that rifaximin and neomycin was superior to neomycin alone in improving symptoms in methane-positive subjects .
OBJECTIVE	To determine the effectiveness of neomycin alone or with rifaximin in improving symptoms in methane-positive C-IBS subjects .
METHODS	A double-blind , randomized , placebo-controlled trial was performed from 2010 to 2013 at three tertiary care centers .
METHODS	Subjects aged 18-65 with C-IBS ( Rome II criteria ) and breath methane ( > 3ppm ) meeting the inclusion and exclusion criteria were recruited .
METHODS	Subjects completed a baseline symptom questionnaire rating the severity of abdominal and bowel symptoms on a visual analog scale and were randomized to receive neomycin and placebo or neomycin and rifaximin for 14 days .
METHODS	Symptom severity was assessed by weekly questionnaire for 2weeks of therapy and 4 additional weeks of follow-up .
RESULTS	Thirty-one subjects ( 16 neomycin and placebo , 15 neomycin and rifaximin ) were included in the intention-to-treat analysis .
RESULTS	Constipation severity was significantly lower in the neomycin and rifaximin group ( 28.630.8 ) compared to neomycin alone ( 61.224.1 ) ( P = 0.0042 ) , with greater improvement in constipation ( P = 0.007 ) , straining ( P = 0.017 ) and bloating ( P = 0.020 ) , but not abdominal pain .
RESULTS	In the neomycin and rifaximin group , subjects with methane < 3ppm after treatment reported significantly lower constipation severity ( 30.521.8 ) than subjects with persistent methane ( 67.232.1 ) ( P = 0.020 ) .
CONCLUSIONS	Rifaximin plus neomycin is superior to neomycin alone in improving multiple C-IBS symptoms .
CONCLUSIONS	This effect is predicted by a reduction in breath methane .

###24547956
CONCLUSIONS	Stellate ganglion block ( SGB ) is effective for treatment of Bell 's palsy in patients with diabetes mellitus .
BACKGROUND	Corticosteroids are widely used for treatment of Bell 's palsy in patients with diabetes mellitus but may induce complications like hyperglycemia , which calls for an alternative therapy .
BACKGROUND	This study aimed to ascertain the effect of SGB on Bell 's palsy in patients with diabetes mellitus .
METHODS	This randomized and single-blinded clinical trial involved 96 diabetic patients with Bell 's palsy that were randomly divided into a control group ( n = 48 ) and a treatment group ( SGB group , n = 48 ) .
METHODS	The House-Brackmann scale and facial disability index ( FDI , including FDIP and FDIS ) were observed before treatment and at 1 and 3 months after treatment for assessment of the outcome .
RESULTS	No statistically significant difference was found between the two groups before treatment as regards the House-Brackmann scale and FDI .
RESULTS	There was a statistically significant difference in FDIP score in the two groups after treatment in comparison with before treatment .
RESULTS	The FDIS score showed a statistical difference between the two groups after treatment .

###24949654
BACKGROUND	Glucose fluctuation often remains to be corrected under basal-supported oral therapy .
BACKGROUND	We investigated the efficacy of adding once-daily rapid-acting insulin in Japanese diabetes patients treated with basal-supported oral therapy .
METHODS	In this 8-week , parallel-group , randomized , open-label trial , 62 Japanese adults with type 2 diabetes treated with insulin glargine and 50 mg of sitagliptin were randomized into the following two arms : the single-bolus group , in which once-daily insulin glulisine was initiated at a main meal at a fifth ( i.e. , 20 % ) the dose of insulin glargine , and the control group , in which the dose of sitagliptin was maximized to 100 mg .
METHODS	The primary end point was the change of glycemic fluctuation assessed with the M-value .
RESULTS	Baseline hemoglobin A1c levels , mean blood glucose profiles , and M-value were 7.2 0.6 % , 9.3 1.7 mmol/L , and 21 13 units , respectively .
RESULTS	At the end of the study , the single-bolus group had a greater reduction of M-value than the control group ( P = 0.02 ) ; the difference was 6.5 units ( 95 % confidence interval , 1.1-11 .9 units ) .
RESULTS	The single-bolus group also had a greater reduction of mean blood glucose levels ( P = 0.01 ) .
RESULTS	There were no significant differences in the incidence of hypoglycemia or the weight change between the two groups ( P > 0.05 ) .
CONCLUSIONS	Adding once-daily insulin glulisine was more effective in controlling the glycemic fluctuation in Japanese type 2 diabetes patients treated with insulin glargine together with sitagliptin .

###25532433
BACKGROUND	Although D2 lymphadenectomy has been shown to improve outcomes in gastric cancer , it may increase postoperative morbidity , mainly owing to splenopancreatic complications .
BACKGROUND	In addition , the effects of nodal dissection along the proper hepatic artery have not been extensively elucidated .
BACKGROUND	We hypothesized that modified D2 ( ie , D1 + ) lymphadenectomy may decrease surgical risks without impairing oncologic adequacy .
METHODS	Patients with node-positive gastric cancer undergoing curative total gastrectomy were intraoperatively randomized to D1 + ( group 1 , 36 patients ) or standard D2 lymphadenectomy ( group 2 , 37 patients ) , the latter including splenectomy and nodal group 12a .
METHODS	The index of estimated benefit was used to assess the efficacy of dissection of each nodal station .
METHODS	The primary endpoint for oncologic adequacy was the disease-free survival ( DFS ) rate .
RESULTS	Surgical complications were significantly more common in group 2 , which also included 2 postoperative deaths .
RESULTS	Overall , 35 patients ( 49 % ) experienced tumor recurrence .
RESULTS	The primary site of tumor relapse and the 5-year DFS rate were not different between the 2 groups .
RESULTS	Involvement of the second nodal level was associated with a worse DFS rate ; however , patients undergoing more extensive lymphadenectomy did not show a better DFS rate .
RESULTS	The incidence of involvement of nodal stations 10 , 11d , and 12a was 5 % , and the 5-year DFS rate was zero .
RESULTS	Consequently , the benefit to dissect such lymph nodes was null .
CONCLUSIONS	These findings suggest that modified D2 lymphadenectomy confers the same oncologic adequacy as standard D2 lymphadenectomy , with a significant reduction of postoperative morbidity .

###24621228
OBJECTIVE	To demonstrate the safety and effectiveness of responsive stimulation at the seizure focus as an adjunctive therapy to reduce the frequency of seizures in adults with medically intractable partial onset seizures arising from one or two seizure foci .
METHODS	Randomized multicenter double-blinded controlled trial of responsive focal cortical stimulation ( RNS System ) .
METHODS	Subjects with medically intractable partial onset seizures from one or two foci were implanted , and 1month postimplant were randomized 1:1 to active or sham stimulation .
METHODS	After the fifth postimplant month , all subjects received responsive stimulation in an open label period ( OLP ) to complete 2years of postimplant follow-up .
RESULTS	All 191 subjects were randomized .
RESULTS	The percent change in seizures at the end of the blinded period was -37.9 % in the active and -17.3 % in the sham stimulation group ( p = 0.012 , Generalized Estimating Equations ) .
RESULTS	The median percent reduction in seizures in the OLP was 44 % at 1year and 53 % at 2years , which represents a progressive and significant improvement with time ( p < 0.0001 ) .
RESULTS	The serious adverse event rate was not different between subjects receiving active and sham stimulation .
RESULTS	Adverse events were consistent with the known risks of an implanted medical device , seizures , and of other epilepsy treatments .
RESULTS	There were no adverse effects on neuropsychological function or mood .
CONCLUSIONS	Responsive stimulation to the seizure focus reduced the frequency of partial-onset seizures acutely , showed improving seizure reduction over time , was well tolerated , and was acceptably safe .
CONCLUSIONS	The RNS System provides an additional treatment option for patients with medically intractable partial-onset seizures .

###25516316
OBJECTIVE	Cognitive impairment develops with pre-diabetes and dementia is a complication of diabetes .
OBJECTIVE	Natural products like turmeric and cinnamon may ameliorate the underlying pathogenesis .
METHODS	People 60 years ( n = 48 ) with newly-recognised untreated pre-diabetes were randomised to a double-blind metabolic study of placebo , turmeric ( 1 g ) , cinnamon ( 2 g ) or both ( 1 g & 2 g respectively ) , ingested at a white bread ( 119 g ) breakfast .
METHODS	Observations were made over 6 hours for pre - and post-working memory ( WM ) , glycaemic and insulin responses and biomarkers of Alzheimer 's disease ( AD ) ( 0 , 2 , 4 and 6 hours ) : amyloid precursor protein ( APP ) , - secretase subunits presenilin-1 ( PS1 ) , presenilin-2 ( PS2 ) , and glycogen synthase kinase ( GSK-3 ) .
METHODS	Differences between natural product users and non-users were determined by Students t and chi square tests ; and between pre-test and post-test WM by Wilcoxon signed rank tests .
METHODS	Interaction between turmeric and cinnamon was tested by 2-way ANOVA .
METHODS	Multivariable linear regression ( MLR ) took account of BMI , glycaemia , insulin and AD biomarkers in the WM responses to turmeric and cinnamon .
RESULTS	No interaction between turmeric and cinnamon was detected .
RESULTS	WM increased from 2.6 to 2.9 out of 3.0 ( p = 0.05 ) with turmeric , but was unchanged with cinnamon .
RESULTS	WM improvement was inversely associated with insulin resistance ( r = -0.418 , p < 0.01 ) , but not with AD biomarkers .
RESULTS	With MLR , the WM responses to turmeric were best predicted with an R2 of 34.5 % ; and with significant turmeric , BMI and insulin/glucose AUC beta-coefficients .
CONCLUSIONS	Co-ingestion of turmeric with white bread increases working memory independent of body fatness , glycaemia , insulin , or AD biomarkers .

###25132784
OBJECTIVE	To compare the bowel cleansing efficacy of same day ingestion of 4-L sulfa-free polyethylene glycol ( 4-L SF-PEG ) vs 2-L polyethylene glycol solution with ascorbic acid ( 2-L PEG + Asc ) in patients undergoing afternoon colonoscopy .
METHODS	206 patients ( mean age 56.7 years , 61 % male ) undergoing outpatient screening or surveillance colonoscopies were prospectively randomized to receive either 4-L SF-PEG ( n = 104 ) or 2-L PEG + Asc solution ( n = 102 ) .
METHODS	Colonoscopies were performed by two blinded endoscopists .
METHODS	Bowel preparation was graded using the Ottawa scale .
METHODS	Each participant completed a satisfaction and side effect survey .
RESULTS	There was no difference in patient demographics amongst groups .
RESULTS	4-L SF-PEG resulted in better Ottawa scores compared to 2-L PEG + Asc , 4.2 vs 4.9 ( P = 0.0186 ) ; left colon : 1.33 vs 1.57 respectively ( P = 0.0224 ) , right colon : 1.38 vs 1.63 respectively ( P = 0.0097 ) .
RESULTS	No difference in Ottawa scores was found for the mid colon or amount of fluid .
RESULTS	Patient satisfaction was similar for both arms but those assigned to 4-L SF-PEG reported less bloating : 23.1 % vs 11.5 % ( P = 0.0235 ) .
RESULTS	Overall polyp detection , adenomatous polyp and advanced adenoma detection rates were similar between the two groups .
CONCLUSIONS	Morning only 4-L SF-PEG provided superior cleansing with less bloating as compared to 2-L PEG + Asc bowel preparation for afternoon colonoscopy .
CONCLUSIONS	Thus , future studies evaluating efficacy of morning only preparation for afternoon colonoscopy should use 4-L SF-PEG as the standard comparator .

###24839825
BACKGROUND	Type B influenza virus is a major epidemic strain responsible for considerable mortality and morbidity .
METHODS	A colloidal gold immunochromatographic strip for the rapid detection of human influenza B virus was developed .
METHODS	This test is based on membrane chromatography and uses colloidal gold conjugated with influenza B virus anti-NP monoclonal antibody as the tracer .
METHODS	The assembled test strip was housed in a plastic case .
RESULTS	The colloid gold strip ( CGS ) specifically detected all influenza B viruses tested and did not react with other respiratory viruses .
RESULTS	Compared with SYBR Green real-time PCR , the sensitivity and specificity of the CGS test was 89.76 % and 99.56 % , respectively , and the consistency ratio between CGS and real-time PCR was 96.06 % in detecting influenza B virus in 710 nasopharyngeal swabs from patients with influenza-like illness in the hospital .
CONCLUSIONS	The CGS array developed in this study enabled typing of influenza B viruses in human clinical specimens .
CONCLUSIONS	Thus , together with the advantages of rapid detection and easy operation without requiring specialized personnel and equipment , this technique is a convenient and relatively inexpensive diagnostic tool for large-scale screening of clinical samples .

###25440652
OBJECTIVE	Minimally invasive techniques commonly are applied to mitral valve surgery ; however , there has been little research investigating the optimal methods of cardiopulmonary bypass for the right minithoracotomy approach .
OBJECTIVE	Controversy exists as to whether a percutaneous superior vena cava drainage cannula ( PSVC ) is necessary during these operations .
OBJECTIVE	The authors , therefore , sought to determine the effect of using a percutaneous superior vena cava catheter on brain near-infrared spectroscopy , blood lactate levels , hemodynamics and surgical parameters .
METHODS	Randomized , blinded , crossover trial .
METHODS	Tertiary care university hospital .
METHODS	Patients undergoing minimally invasive mitral valve surgery via a right minithoracotomy .
METHODS	Twenty minutes of either clamped or unclamped percutaneous superior vena cava neck catheter drainage , during mitral valve repair .
RESULTS	For the primary outcome of brain near-infrared spectroscopy , there were no differences between the two groups ( percutaneous superior vena cava clamped 55.0 % 11.6 % versus unclamped 56.1 % 10.2 % ) ( p = 0.283 ) .
RESULTS	For the secondary outcomes pH ( clamped 7.350.05 versus unclamped 7.370.05 p = 0.015 ) , surgical score ( clamped 1.961.14 versus unclamped 1.220.51 p = 0.002 ) and CVP ( clamped 11.6 mmHg4 .8 mmHg versus unclamped 6.1 mmHg6 .1 mmHg p < 0.001 ) were significantly different .
CONCLUSIONS	The use of a percutaneous superior vena cava drainage improved surgical visualization and lowered CVP , but had no effect on brain near infrared spectroscopy during minimally invasive mitral valve surgery .
CONCLUSIONS	( ClinicalTrials.gov Identifier : NCT01166841 ) .

###24325539
OBJECTIVE	A new gel formulation containing loteprednol etabonate ( LE ) , a C-20 ester corticosteroid used to treat ocular inflammation , was developed to provide increased retention on the ocular surface for improved drug delivery to intraocular tissues .
OBJECTIVE	This investigation evaluated concentrations of LE in tear fluid following topical instillation of LE gel to humans and the ocular and systemic pharmacokinetics of LE following administration to rabbits .
METHODS	LE ophthalmic gel 0.5 % was administered as a single topical dose to human volunteers ( n = 12 ) and Dutch Belted rabbits ( n = 40 ) .
METHODS	In the human study , tear sampling was performed at 6 , 9 , 12 , and 24h after instillation .
METHODS	In the rabbit study , tears and ocular tissues were collected from 5min through 24h postdose .
METHODS	Serial blood samples were collected from one cohort of rabbits for plasma analysis .
METHODS	Concentrations of LE were determined by high performance liquid chromatography tandem mass spectrometry .
RESULTS	In humans , LE was detected in tears at all the time points assessed with mean concentrations of 114g/g at 6h declining to 2.41 g/g at 24h postdose .
RESULTS	In rabbits , LE was detected in all ocular tissues within 5min after dosing .
RESULTS	Maximum concentrations of LE were achieved within 0.5 h and were highest in tear fluid ( 1560g/g ) , followed by bulbar conjunctiva ( 4.03 g/g ) , cornea , ( 2.18 g/g ) , iris/ciliary body ( 0.162 g/g ) , and aqueous humor ( 0.0138 g/mL ) .
RESULTS	LE remained measurable in all ocular tissues through 24h with the exception of aqueous humor .
RESULTS	In contrast , plasma levels of LE were low with no detectable levels after 4h .
CONCLUSIONS	The gel formulation of LE provided prolonged exposure to LE on the ocular surface , with measurable levels in tears through 24h in both humans and rabbits , for delivery of LE to anterior segment tissues , as evidenced by sustained levels of LE in rabbit conjunctiva , cornea , and iris/ciliary body .

###25369357
OBJECTIVE	Long Acting Reversible Contraception ( LARC ) methods are highly effective in reducing the incidence of unwanted pregnancy .
OBJECTIVE	Recent data indicates that the rate of abortion in Grampian , North East of Scotland is above the Scottish average and LARC uptake among young women low .
OBJECTIVE	This study sought to explore young women 's perceptions of LARC , with the aim of developing a strategy to increase LARC uptake .
METHODS	Qualitative study .
METHODS	Sixty five women aged 16-24 were randomly recruited to this qualitative study from community centres and shopping areas .
METHODS	Recruitment and interviews were conducted in friendship pairs , triads or one-to-one basis .
METHODS	Participants were asked about current and past contraception use , views of contraception methods including LARC ; and sources of information about contraception .
METHODS	Data were analysed using thematic content analysis .
RESULTS	Women interviewed were aware of some of the delivery systems used for long acting contraception ( intrauterine devices , implants and injections ) but did not recognise them as ` LARC ' .
RESULTS	` Long acting ' was equated with permanency and the term ` reversible ' appeared to have the opposite effect to its intention .
RESULTS	Intrauterine devices were commonly referred to as ` coil ' .
RESULTS	The women often relied on verbal testimonies from those who had experienced using LARC , many of which were negative and inaccurate .
RESULTS	A lack of in-depth knowledge about LARC and the opinion that LARC methods were for older women were also cited as barriers to use .
CONCLUSIONS	This study shows that negative testimonies and the belief that LARC are not appropriate for young women may discourage LARC uptake .

###25415784
BACKGROUND	Epidural injections are performed to manage lumbar central spinal stenosis pain utilizing caudal , interlaminar , and transforaminal approaches .
BACKGROUND	The literature on the efficacy of epidural injections in managing lumbar central spinal stenosis pain is sparse ; lacking multiple , high quality randomized trials with long-term follow-up .
METHODS	Two randomized controlled trials of the caudal and lumbar interlaminar approaches that assessed 220 patients with lumbar central spinal stenosis were analyzed .
RESULTS	The analysis found efficacy for both caudal and interlaminar approaches in managing chronic pain and disability from central spinal stenosis was demonstrated .
RESULTS	In the patients responsive to treatment , those with at least 3 weeks of improvement with the first 2 procedures , 51 % reported significant improvement with caudal epidural injections , whereas it was 84 % with local anesthetic only with interlaminar epidurals , 57 % with caudal and 83 % with lumbar interlaminar with local anesthetic with steroid .
RESULTS	The response rate was 38 % with caudal and 72 % with lumbar interlaminar with local anesthetic only and 44 % with caudal and 73 % with lumbar interlaminar with local anesthetic with steroid when all patients were considered .
RESULTS	In the interlaminar approach , results were superior for pain relief and functional status with fewer nonresponsive patients compared to the caudal approach .
CONCLUSIONS	The data was derived from 2 previously published randomized , controlled trials rather than comparing 2 techniques in one randomized controlled trial .
CONCLUSIONS	Further , the randomized controlled trials were active control trials without a placebo .
CONCLUSIONS	The results of this assessment showed significant improvement in patients suffering with chronic lumbar spinal stenosis with caudal and interlaminar epidural approaches with local anesthetic only , or with steroids in a long-term follow-up of up to 2 years , in contemporary interventional pain management setting , with the interlaminar approach providing significantly better results .

###24224992
BACKGROUND	Scope of practice in audiology encompasses proficiency in visual inspection of ear canal and tympanic membrane ( TM ) as well as otoscopy interpretation skills to determine normal versus abnormal conditions of outer and middle ear .
BACKGROUND	Audiology students can develop skills in otoscopy through education and supervised training .
BACKGROUND	Studies have shown that additional otoscopy training increased skills in medical students and general practitioners .
BACKGROUND	However , educational and supervised practices targeting otoscopy competency during audiology graduate coursework are lacking .
BACKGROUND	Also , no studies have attempted to determine otoscopy skills among audiology students .
OBJECTIVE	To determine the effectiveness of the otoscopy training model on clinical competency and confidence level of audiology students in performing and interpreting otoscopy .
METHODS	A combination of experimental treatment design with random assignment of treatment and control groups and delayed treatment for control group .
METHODS	Thirty-two first - and second-year audiology graduate students who were enrolled in a pediatric audiology class participated in this study .
METHODS	Students were randomly assigned to the control ( n = 16 , 14 females ) or experimental ( n = 16 , 14 females ) group .
METHODS	Participants in the experimental group received supplementary otoscopy training including didactic otoscopy lectures as well as clinical training using manikin ears .
METHODS	The control group received the same pretest and posttest and then completed a third assessment ( posttest 2 ) after receiving the same training .
METHODS	An evaluation of knowledge and skills regarding otoscopy between groups and time was conducted at three times : ( a ) pretraining , ( b ) upon completion of training for the experimental group , ( c ) upon completion of training by the control group .
METHODS	The evaluation consisted of a written exam , a clinical exam , and a self-perception rating of confidence .
METHODS	Both written exam scores and clinical exam scores ( otoscopy manikin ) were analyzed via two-way analyses of variance ( ANOVAs ) , whereas chi-square ( ) statistic was conducted to evaluate the effects of training on the confidence level of students of both groups .
RESULTS	Experimental and control groups demonstrated significant increased overall competency in otoscopy following the otoscopy training model with didactic and laboratory components .
RESULTS	Posttest confidence ratings showed increases in all groups , and there were no significant differences between groups .
CONCLUSIONS	The need for supplementary otoscopy training was warranted by low knowledge and clinical competency in otoscopy skills of audiology students as measured by pretest mean scores .
CONCLUSIONS	After completing the training , both experimental and control groups showed significant improvement in knowledge and competency .
CONCLUSIONS	Results also suggest that perceived confidence ratings may be misleading in determining students ' clinical otoscopy skills .

###24279701
BACKGROUND	Acceptance of healthcare-associated pneumonia ( HCAP ) as an entity and the associated risk of infection by potentially multidrug-resistant ( MDR ) organisms such as methicillin-resistant Staphylococcus aureus ( MRSA ) , Pseudomonas and Acinetobacter have been debated .
BACKGROUND	We therefore compared patients with HCAP , hospital-acquired pneumonia ( HAP ) , and ventilator-associated pneumonia ( VAP ) enrolled in a trial comparing linezolid with vancomycin for treatment of pneumonia .
METHODS	The analysis included all patients who received study drug .
METHODS	HCAP was defined as pneumonia occurring < 48hours into hospitalization and acquired in a long-term care , subacute , or intermediate health care facility ; following recent hospitalization ; or after chronic dialysis .
RESULTS	Data from 1184 patients ( HCAP = 199 , HAP = 379 , VAP = 606 ) were analyzed .
RESULTS	Compared with HAP and VAP patients , those with HCAP were older , had slightly higher severity scores , and were more likely to have comorbidities .
RESULTS	Pseudomonas aeruginosa was the most common gram-negative organism isolated in all pneumonia classes [ HCAP , 22/199 ( 11.1 % ) ; HAP , 28/379 ( 7.4 % ) ; VAP , 57/606 ( 9.4 % ) ; p = 0.311 ] .
RESULTS	Acinetobacter spp .
RESULTS	were also found with similar frequencies across pneumonia groups .
RESULTS	To address potential enrollment bias toward patients with MRSA pneumonia , we grouped patients by presence or absence of MRSA and found little difference in frequencies of Pseudomonas and Acinetobacter .
CONCLUSIONS	In this population of pneumonia patients , the frequencies of MDR gram-negative pathogens were similar among patients with HCAP , HAP , or VAP .
CONCLUSIONS	Our data support inclusion of HCAP within nosocomial pneumonia guidelines and the recommendation that empiric antibiotic regimens for HCAP should be similar to those for HAP and VAP .

###25832034
BACKGROUND	The higher risk of adverse outcomes after transapical ( TA ) versus transfemoral ( TF ) transcatheter aortic valve replacement ( TAVR ) could be attributable to TA-TAVR being an open surgical procedure or to clinical differences between TA - and TF-TAVR patients .
BACKGROUND	We compared outcomes after neutralizing patient differences using propensity score matching .
RESULTS	From April 2007 to February 2012 , 1100 Placement of Aortic Transcatheter Valves ( PARTNER ) - I patients underwent TA-TAVR and 1521 underwent TF-TAVR with Edwards SAPIEN balloon-expandable bioprostheses .
RESULTS	Propensity matching based on 111 preprocedural variables , exclusive of femoral access morphology , identified 501 well-matched patient pairs ( 46 % of possible matches ) , 95 % of whom had peripheral arterial disease .
RESULTS	Matched TA-TAVR patients experienced more adverse procedural events , longer length of stay ( 5 versus 8 days ; P < 0.0001 ) , and slower recovery ( New York Heart Association class I , 31 % versus 38 % at 30 days , equalizing by 6 months at 51 % versus 47 % ) ; stroke risk was similar ( 3.4 % versus 3.3 % at 30 days and 6.0 % versus 6.7 % at 3 years ) ; mortality was elevated for the first 6 postprocedural months ( 19 % versus 12 % ; P = 0.01 ) ; but aortic regurgitation was less ( 34 % versus 52 % mild and 8.9 % versus 12 % moderate to severe at discharge , P = 0.001 ; 36 % versus 50 % mild and 10 % versus 15 % moderate to severe at 6 months , P < 0.0001 ) .
CONCLUSIONS	The likelihood of adverse periprocedural events and prolonged recovery is greater after TA-TAVR than TF-TAVR in vasculopathic patients after accounting for differences in cardiovascular risk factors , although stroke risk is equivalent and aortic regurgitation is less .
CONCLUSIONS	As smaller delivery systems permit TF-TAVR in many of these patients , we recommend a TF-first access strategy for TAVR when anatomically feasible .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT00530894 .

###24678066
BACKGROUND	The most dreaded hemorrhagic complication in endoscopic endonasal surgery is injury to the internal carotid artery ( ICA ) .
BACKGROUND	Although a number of treatment protocols are currently used , none have been formally investigated .
BACKGROUND	This study aims to compare the efficacy of the muscle patch , bipolar diathermy , and aneurysm clip on hemostasis , pseudoaneurysm formation , and long-term vessel patency for different injury types in a sheep model of carotid bleeding .
METHODS	Twenty-seven sheep underwent ICA dissection/isolation followed by the artery placement within a modified `` sinus model otorhino neuro trainer '' ( SIMONT ) model .
METHODS	Standardized linear , punch , and stellate injuries were made .
METHODS	Randomization of sheep to receive 1 of 3 hemostatic techniques was performed ( muscle , bipolar , clip ) .
METHODS	Specific outcome measures included attainment of primary hemostasis , time to hemostasis , blood loss , pseudoaneurysm formation , and carotid patency on follow-up magnetic resonance imaging ( MRI ) .
RESULTS	Bipolar achieved primary hemostasis in 7 of 9 cases and 2 cases of secondary hemorrhage .
RESULTS	It had no associated pseudoaneurysm formation .
RESULTS	Carotid patency was variable on follow-up MRI .
RESULTS	Muscle patch achieved 100 % primary hemostasis with 2 cases of secondary hemorrhage .
RESULTS	There were 2 cases of pseudoaneurysm and 100 % patency rate on follow-up MRI .
RESULTS	Aneurysm clip achieved 100 % primary hemostasis with 1 case of secondary hemorrhage .
RESULTS	No pseudoaneurysm formation and a 50 % rate of carotid insufficiency on MRI .
CONCLUSIONS	This study shows that the crushed muscle patch and aneurysm clip can be viable options in the management of ICA injury with short-term and long-term benefits .
CONCLUSIONS	Complications associated with these techniques were comparable if not reduced when compared to the published literature .

###25283586
BACKGROUND	The hemostatic and inflammatory systems may activate each other .
BACKGROUND	Endometriosis is a chronic inflammatory disease affecting 10 % of women .
BACKGROUND	The objective of this study was to compare the hemostatic effects of two treatments widely prescribed to women with endometriosis : the levonorgestrel intrauterine system ( LNG-IUS ) and the gonadotropin-releasing hormone analog ( GnRHa ) leuprolide acetate .
METHODS	In this randomized open-label controlled trial , 44 women with endometriosis were randomly allocated to one of two groups : 22 women were assigned to use LNG-IUS and 22 to use GnRHa .
METHODS	The assessed variables were D-dimers , fibrinogen , prothrombin time , activated partial thromboplastin time , coagulation factors ( F ) II , V , VII , VIII , IX , X , and XI , antithrombin ( AT ) , protein C , free protein S , tissue plasminogen activator ( t-PA ) , 2-antiplasmin , thrombin-antithrombin complex , and prothrombin fragment 1 +2 .
METHODS	All variables were assessed before treatment and six months after treatment onset .
RESULTS	In the LNG-IUS group , FVIII decreased 10 % after six months of use .
RESULTS	In the GnRHa group , there was a 6 % increase in AT , 29 % reduction in D-dimers , and 19 % increase in t-PA .
RESULTS	The LNG-IUS users exhibited a significantly greater reduction of FVIII than the GnRHa users ( LNG-IUS : -6.4 14.3 % vs. GnRHa : 4.2 12.3 % , p = 0.02 ) .
RESULTS	The women in the GnRHa group exhibited a greater increase of AT than the LNG-IUS users ( LNG-IUS : -0.7 9.5 % vs. GnRHa : 6.5 10.1 % , p = 0.02 ) .
CONCLUSIONS	Both hormonal treatments for endometriosis exhibited no association with a procoagulant profile .

###26027628
BACKGROUND	Elderly patients with ST-segment elevation myocardial infarction ( STEMI ) have worse outcomes and a greater risk of intracranial bleeding than nonelderly patients .
BACKGROUND	Baseline characteristics , clinical outcomes , and the relationship of the tenecteplase ( TNK ) dose reduction to the efficacy , safety , and electrocardiographic indicators of reperfusion efficacy were evaluated in STEMI patients 75 years .
METHODS	The STREAM trial evaluated early presenting STEMI patients who could not undergo primary percutaneous coronary intervention within 1 hour of first medical contact .
METHODS	Because of excess intracranial hemorrhage ( ICH ) in patients 75 years , the dose of TNK was reduced by 50 % .
RESULTS	Before dose amendment , there were 3 ( 7.1 % ) of 42 elderly patients with ICH ; 2 of these were fatal , whereas no ICH occurred in the 93 elderly patients who received half-dose TNK postamendment .
RESULTS	The median extent of ST-segment elevation resolution ( 50 % ) and proportion of patients with 2 mm in the electrocardiogram lead with greatest ST-segment elevation was comparable in elderly patients preamendment and postamendment ( 63.2 % vs 56.0 % and 43.6 % vs 40.0 % , respectively ) .
RESULTS	Patients requiring rescue coronary intervention after TNK was also similar ( 42.9 % vs 44.1 % ) .
RESULTS	The primary composite end point ( 30-day all-cause death , cardiogenic shock , congestive heart failure , and reinfarction ) was 31.0 % before versus 24.7 % postamendment .
CONCLUSIONS	Our data , from a modest-sized population of elderly STEMI patients , indicate that half-dose TNK reduces the likelihood of ICH without compromising reperfusion efficacy .
CONCLUSIONS	These observations are hypothesis generating and warrant further confirmation in randomized clinical trials in the elderly .

###24698829
BACKGROUND	The aim of this study was to compare the efficacy , safety , antiplaque and antigingivitis properties of a herbal mouthwash with chlorhexidine mouthwash .
METHODS	A double-blinded randomized clinical trial was conducted among 72 undergraduate students with age group 18-24 years .
METHODS	They were randomly divided into three mouthwash group with 24 participants in each group .
METHODS	Group A ( herbal ) , Group B ( chlorhexidine ) and Group C ( normal saline ) .
METHODS	The Turesky et al. 1970 plaque index and Loe and Silness 1963 gingival index was recorded .
METHODS	Student 's t-test and one-way ANOVA were used to test the significance .
RESULTS	A statistically highly significant difference was obtained between mouthwash B and C ( p = 0.00 ) and a significant difference between mouthwash A and C ( p = 0.004 ) , showing that chlorhexidine was superior to herbal mouthwash and saline .
RESULTS	However , there was a nonsignificant difference between mouthwash A and B ( p = 0.435 ) showing that herbal and chlorhexidine mouthwash was equally effective in reducing plaque and gingivitis .
CONCLUSIONS	The efficacy of herbal mouthwash was equally effective in reducing plaque and gingivitis as compared to chlorhexidine mouthwash and may be considered as a good alternative .
CONCLUSIONS	The chlorhexidine mouthwash was reported with many side effects which limits its acceptability and long-term use , whereas the presently tested herbal mouthwash had no side effects apart from mild burning sensation .

###25677355
OBJECTIVE	Exposure to trauma reminders has been considered imperative in psychotherapy for posttraumatic stress disorder ( PTSD ) .
OBJECTIVE	The authors tested interpersonal psychotherapy ( IPT ) , which has demonstrated antidepressant efficacy and shown promise in pilot PTSD research as a non-exposure-based non-cognitive-behavioral PTSD treatment .
METHODS	The authors conducted a randomized 14-week trial comparing IPT , prolonged exposure ( an exposure-based exemplar ) , and relaxation therapy ( an active control psychotherapy ) in 110 unmedicated patients who had chronic PTSD and a score > 50 on the Clinician-Administered PTSD Scale ( CAPS ) .
METHODS	Randomization stratified for comorbid major depression .
METHODS	The authors hypothesized that IPT would be no more than minimally inferior ( a difference < 12.5 points in CAPS score ) to prolonged exposure .
RESULTS	All therapies had large within-group effect sizes ( d values , 1.32-1 .88 ) .
RESULTS	Rates of response , defined as an improvement of > 30 % in CAPS score , were 63 % for IPT , 47 % for prolonged exposure , and 38 % for relaxation therapy ( not significantly different between groups ) .
RESULTS	CAPS outcomes for IPT and prolonged exposure differed by 5.5 points ( not significant ) , and the null hypothesis of more than minimal IPT inferiority was rejected ( p = 0.035 ) .
RESULTS	Patients with comorbid major depression were nine times more likely than nondepressed patients to drop out of prolonged exposure therapy .
RESULTS	IPT and prolonged exposure improved quality of life and social functioning more than relaxation therapy .
CONCLUSIONS	This study demonstrated noninferiority of individual IPT for PTSD compared with the gold-standard treatment .
CONCLUSIONS	IPT had ( nonsignificantly ) lower attrition and higher response rates than prolonged exposure .
CONCLUSIONS	Contrary to widespread clinical belief , PTSD treatment may not require cognitive-behavioral exposure to trauma reminders .
CONCLUSIONS	Moreover , patients with comorbid major depression may fare better with IPT than with prolonged exposure .

###24246211
OBJECTIVE	To investigate the impact of cyclooxygenase-2 ( COX-2 ) inhibitor with - adrenoceptor blocker ( - blocker ) for men with benign prostatic hyperplasia ( BPH ) and lower urinary tract symptoms ( LUTS ) for detecting prostate cancer in men with elevated prostate specific antigen ( PSA ) .
METHODS	Male patients with clinical BPH , elevated serum PSA ( > 4ng/ml ) , and significant LUTS ( International Prostate Symptom Score [ IPSS ] 8 ) were randomly assigned to receive doxazosin 4mg daily plus celecoxib 200mg daily ( study group ) or doxazosin 4mg daily alone ( control group ) for 3months .
METHODS	Patients were investigated for the changes in IPSS , maximum flow rate ( Qmax ) , voided volume , postvoid residual ( PVR ) volume and serum PSA from baseline to 3months after treatment .
METHODS	After the 3-month therapy , prostate biopsy was performed in the patients whose PSA were still higher than 4ng/ml .
RESULTS	A total of 82 patients completed the study .
RESULTS	The improvement in IPSS-voiding was significantly greater in the study group than control group ( p = 0.034 ) .
RESULTS	In the study group , patients with prostatic hyperplasia or inflammation on the prostate biopsy had a significantly better result than in patients with prostatic adenocarcinoma , typically in the changes of Qmax and voided volume ( p = 0.012 and p = 0.005 , respectively ) .
RESULTS	The PSA level in the study group showed significant improvement after treatment ( p < 0.01 ) .
RESULTS	However , prostate cancer detection rate failed to show any significant difference between the patients whose PSA levels decreased or not ( 6/21 = 29 % vs. 5/24 = 20 % , respectively , p = 0.447 ) .
CONCLUSIONS	Treatment with COX-2 inhibitor and - blocker for 3months could not improve prostatic cancer detection rate .
CONCLUSIONS	But it could increase therapeutic effectiveness of LUTS in men with BPH and elevated PSA levels .
CONCLUSIONS	The changes in Qmax and voided volume after combination treatment were significantly greater in patients with prostatic hyperplasia or inflammation than adenocarcinoma .

###25310968
BACKGROUND	A variety of analgesic agents are available , and which one can be used in dogs and cats is a highly controversial issue , existing however a fear in the use of opiates due to possible adverse effects that these drugs can cause .
BACKGROUND	The aim of this study was to compare the analgesic effect provided by the administration of tramadol or pethidine on early postoperative pain of cats undergoing ovariohysterectomy in a double-blind prospective study .
BACKGROUND	Fourty-two animals were randomly assigned into three groups .
BACKGROUND	Pet received pethidine ( 6 mg/kg ) , Tra 2 received tramadol ( 2 mg/kg ) and Tra 4 received tramadol ( 4 mg/kg ) ; all intramuscularly and associated with acepromazine ( 0.1 mg/kg ) .
BACKGROUND	The efficacy of each analgesic regimen was evaluated prior to surgery ( baseline - TBL ) , during surgery and 1 , 3 and 6 hours after extubation with subjective pain scale , physiologic parameters , serum concentrations of glucose , cortisol and IL-6 .
RESULTS	Changes in cardiovascular system were not clinically relevant .
RESULTS	There were no significant differences in pain scores ( P > 0.05 ) during the study , although the number of rescue analgesia was significantly higher ( P < 0.05 ) at Pet group ( 5/14 ) than Tra 4 group ( 0/14 ) , whereas in Tra 2 , two animals ( 2/14 ) required additional analgesia .
RESULTS	The serum cortisol values of Pet group were significantly higher at T1h T3h ( P < 0.05 ) and T6h ( P < 0.01 ) when compared to baseline ( induction ) , also it was noticed a significant difference among the groups at T6h ( Pet values were higher than Tra 2 and Tra 4 ; P < 0.05 ) .
CONCLUSIONS	Tramadol provided adequate analgesia and it was more effective than pethidine to at least six hours for the studied animals .
CONCLUSIONS	At the higher dose ( 4 mg/kg ) tramadol is probably more effective , since rescue analgesia was not necessary .
CONCLUSIONS	No significant changes were observed physiological parameter that could contraindicate the use of these opioid in described doses , for the feline species .

###25239491
OBJECTIVE	CD133 + cells confer angiogenic potential and may be beneficial for the treatment of critical limb ischemia ( CLI ) .
OBJECTIVE	However , patient selection , blinding methods and end points for clinical trials are challenging .
OBJECTIVE	We hypothesized that bilateral intramuscular administration of cytokine-mobilized CD133 + cells in ambulatory patients with refractory CLI would be feasible and safe .
METHODS	In this double-blind , randomized sham-controlled trial , subjects received subcutaneous injections of granulocyte colony-stimulating factor ( 10 g/kg per day ) for 5 days , followed by leukapheresis , and intramuscular administration of 50-400 million sorted CD133 + cells delivered into both legs .
METHODS	Control subjects received normal saline injections , sham leukapheresis and intramuscular injection of placebo buffered solution .
METHODS	Subjects were followed for 1 year .
METHODS	An aliquot of CD133 + cells was collected from each subject to test for genes associated with cell senescence .
RESULTS	Seventy subjects were screened , of whom 10 were eligible .
RESULTS	Subject enrollment was suspended because of a high rate of mobilization failure in subjects randomly assigned to treatment .
RESULTS	Of 10 subjects enrolled ( 7 randomly assigned to treatment , 3 randomly assigned to control ) , there were no differences in serious adverse events at 12 months , and blinding was preserved .
RESULTS	There were non-significant trends toward improved amputation-free survival , 6-minute walk distance , walking impairment questionnaire and quality of life in subjects randomly assigned to treatment .
RESULTS	Successful CD133 + mobilizers expressed fewer senescence-associated genes compared with poor mobilizers .
CONCLUSIONS	Bilateral administration of autologous CD133 + cells in ambulatory CLI subjects was safe , and blinding was preserved .
CONCLUSIONS	However , poor mobilization efficiency combined with high CD133 + senescence suggests futility in this approach .

###24886402
BACKGROUND	Severe borderline personality disorder is associated with a very high psychosocial and economic burden .
BACKGROUND	Current treatment guidelines suggest that several manualized treatments , including day hospital Mentalization-Based Treatment ( MBT-DH ) , are effective in these patients .
BACKGROUND	However , only two randomized controlled trials have compared manualized MBT-DH with treatment as usual .
BACKGROUND	Given the relative paucity of data supporting the efficacy and cost-effectiveness of MBT-DH , the possible influence of researcher allegiance in one of the trials , and potential problems with the generalization of findings to mental health systems in other countries , this multi-site randomized trial aims to investigate the efficacy and cost-effectiveness of manualized MBT-DH compared to manualized specialist treatment as usual in The Netherlands .
METHODS	The trial is being conducted at two sites in The Netherlands .
METHODS	Patients with a DSM-IV-TR diagnosis of borderline personality disorder and a score of20 on the Borderline Personality Disorder Severity Index were randomly allocated to MBT-DH or treatment as usual .
METHODS	The MBT-DH program consists of a maximum of 18months ' intensive treatment , followed by a maximum of 18months of maintenance therapy .
METHODS	Specialist treatment as usual is provided by the City Crisis Service in Amsterdam , a service that specializes in treating patients with personality disorders , offering manualized , non-MBT interventions including family interventions , Linehan training , social skills training , and pharmacotherapy , without a maximum time limit .
METHODS	Patients are assessed at baseline and subsequently every 6months up to 36months after the start of treatment .
METHODS	The primary outcome measure is the frequency and severity of manifestations of borderline personality disorder as assessed by the Borderline Personality Disorder Severity Index .
METHODS	Secondary outcome measures include parasuicidal behaviour , symptomatic distress , social and interpersonal functioning , personality functioning , attachment , capacity for mentalizing and quality of life .
METHODS	Cost-effectiveness is assessed in terms of the cost per quality-adjusted life year .
METHODS	Outcomes will be analyzed using multilevel analyses based on intention-to-treat principles .
CONCLUSIONS	Severe borderline personality disorder is a serious psychological disorder that is associated with high burden .
CONCLUSIONS	This multi-site randomized trial will provide further data concerning the efficacy and cost-effectiveness of MBT-DH for these patients .
BACKGROUND	NTR2175 .

###24646102
OBJECTIVE	The objective of the study was to determine whether vitamin D ( vitD ) supplementation during pregnancy affects obstetric and neonatal outcomes .
METHODS	The study was conducted at a university hospital in Karachi , Pakistan .
METHODS	The study was a single-center , open-label , randomized , controlled trial of routine care ( group A , 200 mg ferrous sulfate and 600 mg calcium daily ) vs vitD supplementation ( group B , 4000 IU vitamin D3 daily ) , started at 20 weeks and continued till delivery .
METHODS	Maternal serum samples of 25-hydroxyvitamin D ( 25OHD ) were collected at baseline and delivery .
METHODS	Neonatal vitD status was assessed in cord blood or in neonatal serum samples within 48 hours of birth .
METHODS	Obstetric outcomes included gestational hypertension , gestational diabetes , and preterm labor , and neonatal well-being included small for gestational age , birth weight , length , head circumference , and 1 - and 5-minute Apgar scores .
RESULTS	Of 207 gravidae enrolled , 193 completed the trial .
RESULTS	Maternal age , vitD status , and gestational age at enrollment were comparable between the two groups .
RESULTS	At delivery , maternal 25OHD was increased in group B ( 18.3 11 ng/dL vs 8.82 11.84 ng/dL ( P = .001 ) compared with group A ( 6.9 7.0 ng/dL vs 6.32 3.97 ng/dL , P = .06 ) .
RESULTS	The obstetric outcomes were comparable between the two groups ( P > .05 ) .
RESULTS	Neonatal 25OHD levels were significantly higher in group B compared with group A ( 19.22 12.19 ng/dL vs 6.27 5.2 ng/dL ) .
RESULTS	There was positive correlation between maternal and neonatal 25OHD levels ( r = 0.83 , P = .001 ) .
RESULTS	One - and 5-minute Apgar scores were significantly higher in group B ( 7.10 0.66 vs 6.90 0.50 , P = .026 , and 8.53 0.68 vs 8.33 0.81 , P = .051 , respectively ) .
RESULTS	Neonatal anthropometric parameters were comparable between the two groups ( P > .05 ) .
CONCLUSIONS	Maternal vitD supplementation improved maternal and neonatal vitD status .

###24390522
OBJECTIVE	Although caloric restriction is a widely used intervention to reduce body weight and insulin resistance , many patients are unable to comply with such dietary therapy for long periods .
OBJECTIVE	The clinical effectiveness of low-carbohydrate diets was recently described in a position statement of Diabetes UK and a scientific review conducted by the American Diabetes Association .
OBJECTIVE	However , randomised trials of dietary interventions in Japanese patients with type 2 diabetes are scarce .
OBJECTIVE	Therefore , the aim of this study was to examine the effects of a non-calorie-restricted , low-carbohydrate diet in Japanese patients unable to adhere to a calorie-restricted diet .
METHODS	The enrolled patients were randomly allocated to receive a conventional calorie-restricted diet or low-carbohydrate diet .
METHODS	The patients received consultations every two months from a registered dietician for six months .
METHODS	We compared the effects of the two dietary interventions on glycaemic control and metabolic profiles .
RESULTS	The HbA1c levels decreased significantly from baseline to six months in the low-carbohydrate diet group ( baseline 7.60.4 % , six months 7.00.7 % , p = 0.03 ) but not in the calorie-restricted group ( baseline 7.70.6 % , six months 7.51.0 % , n.s. ) , ( between-group comparison , p = 0.03 ) .
RESULTS	The patients in the former group also experienced improvements in their triglyceride levels , without experiencing any major adverse effects or a decline in the quality of life .
CONCLUSIONS	Our findings suggest that a low-carbohydrate diet is effective in lowering the HbA1c and triglyceride levels in patients with type 2 diabetes who are unable to adhere to a calorie-restricted diet .

###24389932
OBJECTIVE	A randomized controlled clinical trial was implemented to evaluate the effectiveness of combined mild hyperthermia therapy ( body core temperature 38.4 C ) and multimodal inpatient rehabilitation for patients suffering from chronic low back pain when compared to multimodal pain therapy alone .
METHODS	A total of 88patients were randomly assigned to the combined or single therapeutic schemes according to a block randomization scheme .
METHODS	According to the trial inclusion criteria all patients suffered from chronic low back pain and showed morphological degeneration .
METHODS	All patients underwent a 12-day inpatient multimodal pain therapy , which was complemented with a 6-session schedule of mild hyperthermia therapy for the intervention group ( 1h at 38.6 C ) .
METHODS	On admission and 3months after treatment the study patients were asked to complete an interview assessment with the Oswestry low back pain disability questionnaire ( Oswestry disability index ) .
METHODS	The change in the Oswestry disability index total score ( % ) 3months after versus before therapy was defined as the primary clinical endpoint of the investigation .
METHODS	The patients in the control group and in the intervention group had a median age of 50years .
METHODS	In the intervention group 70 % of the patients were female and 55 % reported having half to full time employment compared to 55 % and 43 % in the control group , respectively .
RESULTS	On admission the control patients reported a median Oswestry disability index of 64 % and on recall the same of 64 % .
RESULTS	The intervention group showed median Oswestry disability index estimates of 60 % and 66 % , respectively .
RESULTS	The changes in the overall Oswestry disability index after 3months differed significantly with an estimated 6 % for the intervention group versus 0 % for the control group ( Wilcoxon p = 0.050 ) .
CONCLUSIONS	When combined with a multimodal inpatient lower back pain functional therapy in patients showing morphological degeneration , the mild hyperthermia therapy demonstrated statistically significant , although not clinically relevant benefits in comparison to the multimodal treatment alone .
CONCLUSIONS	However , regarding the moderate overall patient-related benefits as measured in terms of the Oswestry disability index , the benefit of the underlying multimodal therapy concept implementation must be critically discussed irrespective of its combination with mild hyperthermia therapy .

###25092036
BACKGROUND	Probiotics have treatment efficacy in irritable bowel syndrome ( IBS ) , but the exact mechanism remains obscure .
BACKGROUND	One hypothesis is the mediation of melatonin levels , leading to changes in IBS symptoms .
OBJECTIVE	The purpose of this study was to evaluate the effects of a probiotic , VSL # 3 , on symptoms , psychological and sleep parameters , and pain sensitivity in IBS , and relate these parameters to in vivo melatonin levels .
METHODS	Forty-two IBS patients were randomly assigned to receive VSL # 3 or placebo for 6 weeks .
METHODS	Subjects completed bowel and psychological questionnaires , underwent rectal sensitivity testing and saliva melatonin assays .
RESULTS	Abdominal pain duration and distension intensity decreased significantly in the probiotic group , along with an increase in rectal distension pain thresholds .
RESULTS	A correlation between increase in pain tolerance and improvement in abdominal pain scores ( r = 0.51 , p = 0.02 ) was seen with probiotic .
RESULTS	There was an increase in salivary morning melatonin levels in males treated with VSL # 3 , which correlated ( r = 0.61 ) with improved satisfaction in bowel habits .
RESULTS	When grouped based on baseline diurnal melatonin levels , patients with normal diurnal fluctuations showed an increase in morning melatonin levels with VSL # 3 treatment , which significantly correlated with improved satisfaction in bowel habits ( r = 0.68 ) .
RESULTS	They also had reduced symptom severity scores and abdominal pain duration when treated with VSL # 3 , as well as satisfaction with bowel movements and quality-of-life .
CONCLUSIONS	VSL # 3 improved symptoms and increased rectal pain thresholds .
CONCLUSIONS	Symptom improvement correlated with a rise in morning melatonin , significant in males and subjects with normal circadian rhythm .
CONCLUSIONS	This suggests that probiotics may act by influencing melatonin production , hence modulating IBS symptoms , in individuals with a normal circadian rhythm .

###25519680
BACKGROUND	Charcot-Marie-Tooth type 1A disease ( CMT1A ) is a rare orphan inherited neuropathy caused by an autosomal dominant duplication of a gene encoding for the structural myelin protein PMP22 , which induces abnormal Schwann cell differentiation and dysmyelination , eventually leading to axonal suffering then loss and muscle wasting .
BACKGROUND	We favour the idea that diseases can be more efficiently treated when targeting multiple disease-relevant pathways .
BACKGROUND	In CMT1A patients , we therefore tested the potential of PXT3003 , a low-dose combination of three already approved compounds ( baclofen , naltrexone and sorbitol ) .
BACKGROUND	Our study conceptually builds on preclinical experiments highlighting a pleiotropic mechanism of action that includes downregulation of PMP22 .
BACKGROUND	The primary objective was to assess safety and tolerability of PXT3003 .
BACKGROUND	The secondary objective aimed at an exploratory analysis of efficacy of PXT3003 in CMT1A , to be used for designing next clinical development stages ( Phase 2b/3 ) .
METHODS	80 adult patients with mild-to-moderate CMT1A received in double-blind for 1 year Placebo or one of the three increasing doses of PXT3003 tested , in four equal groups .
METHODS	Safety and tolerability were assessed with the incidence of related adverse events .
METHODS	Efficacy was assessed using the Charcot-Marie-Tooth Neuropathy Score ( CMTNS ) and the Overall Neuropathy Limitations Scale ( ONLS ) as main endpoints , as well as various clinical and electrophysiological outcomes .
RESULTS	This trial confirmed the safety and tolerability of PXT3003 .
RESULTS	The highest dose ( HD ) showed consistent evidence of improvement beyond stabilization .
RESULTS	CMTNS and ONLS , with a significant improvement of respectively of 8 % ( 0.4 % - 16.2 % ) and 12.1 % ( 2 % - 23.2 % ) in the HD group versus the pool of all other groups , appear to be the most sensitive clinical endpoints to treatment despite their quasi-stability over one year under Placebo .
RESULTS	Patients who did not deteriorate over one year were significantly more frequent in the HD group .
CONCLUSIONS	These results confirm that PXT3003 deserves further investigation in adults and could greatly benefit CMT1A-diagnosed children , usually less affected than adults .
BACKGROUND	EudraCT Number : 2010-023097-40 .
BACKGROUND	ClinicalTrials.gov Identifier : NCT01401257 .
BACKGROUND	The Committee for Orphan Medicinal Products issued in February 2014 a positive opinion on the application for orphan designation for PXT3003 ( EMA/OD/193 / 13 ) .

###24549094
BACKGROUND	NaCl 7.2 % / 6 % hydroxyethyl starch ( HES ) 200/0 .5 ( HSH ) has shown its beneficial effects in cardiac surgery and immunomodulatory values in experiment and human studies .
BACKGROUND	However , there is concern regarding detrimental renal effects of chloride and HES in the intensive care setting .
OBJECTIVE	The objective of this study was to evaluate the influence of HSH on kidney integrity and the level of inflammatory mediators in on-pump coronary artery bypass surgery patients .
METHODS	This was a single-center , prospective , randomized , single-blind pilot study .
METHODS	This work was performed at a tertiary cardiothoracic referral center during the period from February to August 2012 .
METHODS	Forty patients scheduled for on-pump coronary artery bypass surgery were included .
METHODS	PATIENTS were randomized to receive once either 7.2 % NaCl/6 % HES 200/0 .5 ( HSH group , n = 20 ) or placebo ( 0.9 % NaCl ; control group , n = 20 ) at a dose of 4 mLkg for 30 min after anesthesia induction .
METHODS	The primary end point was the incidence of acute kidney injury ( AKI ) defined according to the Kidney Disease : Improving Global Outcomes .
METHODS	Secondary end points were peak serum cystatin C , peak urine neutrophil gelatinase-associated lipocalin , plasma levels of interleukin 6 ( IL-6 ) , IL-10 , intercellular adhesion molecule 1 , and endothelial-leukocyte adhesion molecule ( E-selectin ) .
RESULTS	The incidence of AKI within 48 h was similar between the groups ( HSH : four patients [ 20 % ] ; control : six patients [ 30 % ] ) .
RESULTS	There was a significantly lower peak value for serum cystatin C in the HSH group ( 0.83 [ 0.73-0 .89 ] mgL ) compared with the control group ( 1.02 [ 0.88-1 .15 ] mgL ; P = 0.001 ) .
RESULTS	PATIENTS in both groups had similar peak postoperative urine neutrophil gelatinase-associated lipocalin concentrations .
RESULTS	NaCl 7.2 % / 6 % hydroxyethyl starch 200/0 .5 significantly reduces levels of IL-6 and IL-10 at 4 h after cardiopulmonary bypass and intercellular adhesion molecule 1 and E-selectin at 4 h after cardiopulmonary bypass and on postoperative day 1 ( P < 0.05 for all ) .
CONCLUSIONS	NaCl 7.2 % / 6 % hydroxyethyl starch 200/0 .5 does not lead to the increase in AKI incidence when used for the volume therapy in on-pump coronary artery bypass surgery patients .
CONCLUSIONS	NaCl 7.2 % / 6 % hydroxyethyl starch 200/0 .5 usage enhanced neither tubular injury nor alteration of glomerular filtration .
CONCLUSIONS	In addition , HSH can reduce the level of the inflammatory mediators after surgery .

###24807340
OBJECTIVE	To compare ondansetron with metoclopramide in the treatment of hyperemesis gravidarum .
METHODS	We enrolled 160 women with hyperemesis gravidarum in a double-blind randomized trial .
METHODS	Participants were randomized to intravenous 4 mg ondansetron or 10 mg metoclopramide every 8 hours for 24 hours .
METHODS	Participants kept an emesis diary for 24 hours ; at 24 hours , they expressed their well-being using a 10-point visual numeric rating scale and answered an adverse effects questionnaire .
METHODS	Nausea intensity was evaluated using a 10-point visual numeric rating scale at enrollment and at 8 , 16 , and 24 hours .
METHODS	Primary analysis was on an intention-to-treat basis .
RESULTS	Eighty women each were randomized to ondansetron or metoclopramide .
RESULTS	Median well-being visual numeric rating scale scores were 9 ( range , 5-10 ) compared with 9 ( range , 4-10 ) ( P = .33 ) and vomiting episodes in the first 24 hours were 1 ( range , 0-9 ) compared with 2 ( range , 0-23 ) ( P = .38 ) for ondansetron compared with metoclopramide , respectively .
RESULTS	Repeat-measures analysis of variance of nausea visual numeric rating scale showed no difference between study drugs ( P = .22 ) .
RESULTS	Reported rates of drowsiness ( 12.5 % compared with 30 % ; P = .01 ; number needed to treat to benefit , 6 ) , xerostomia ( 10.0 % compared with 23.8 % ; P < .01 ; number needed to treat to benefit , 8 ) , and persistent ketonuria at 24 hours ( 12.5 % compared with 30 % ; P = .01 ; number needed to treat to benefit , 6 ) were less frequent with ondansetron .
RESULTS	Length of hospital stay was similar .
CONCLUSIONS	Ondansetron and metoclopramide demonstrated similar antiemetic and antinauseant effects in hyperemesis gravidarum .
CONCLUSIONS	However , the overall profile , particularly regarding adverse effects , was better with ondansetron .
CONCLUSIONS	In our setting , metoclopramide was significantly less expensive than ondansetron and remained a reasonable antiemetic choice .
BACKGROUND	ISRCN Register , www.isrctn.org , ISRCTN00592566 .
METHODS	I.

###24345529
OBJECTIVE	To evaluate once-daily nepafenac 0.3 % to prevent and treat ocular pain and inflammation after cataract surgery .
METHODS	Sixty-five centers in the United States and Europe .
METHODS	Randomized double-masked vehicle - and active-controlled phase 3 study .
METHODS	Patients received nepafenac 0.3 % once daily , nepafenac 0.1 % 3 times daily , or their respective vehicles from day -1 to day 14 after cataract extraction .
METHODS	An additional drop of study drug was administered 30 to 120 minutes preoperatively .
METHODS	The primary endpoint was the percentage of patients with a cure for inflammation ( score of 0 for both aqueous cells and flare ) at day 14 .
RESULTS	Of randomized patients , 817 received nepafenac 0.3 % , 819 received nepafenac 0.1 % , and 200 and 206 received the respective vehicles .
RESULTS	Significantly more nepafenac 0.3 % patients had no inflammation ( 68.4 % versus 34.0 % ) and were pain free ( 91.0 % versus 49.7 % ) at day 14 than vehicle patients ( both P < .0001 ) .
RESULTS	Nepafenac 0.3 % was noninferior to nepafenac 0.1 % for inflammation ( 95 % confidence interval [ CI ] , -5.73 % to 3.17 % ) and pain-free rates ( 95 % CI , -3.08 % to 2.70 % ) .
RESULTS	At all postoperative visits , fewer treatment failures ( P. 0012 ) and more clinical successes ( P .0264 ) were observed with nepafenac 0.3 % versus vehicle .
RESULTS	Nepafenac 0.3 % was well tolerated and had a safety profile comparable to that of nepafenac 0.1 % .
CONCLUSIONS	Once-daily nepafenac 0.3 % was noninferior to nepafenac 0.1 % 3 times daily for prevention and treatment of ocular inflammation and pain following cataract surgery .
CONCLUSIONS	The safety of nepafenac 0.3 % was comparable to that of nepafenac 0.1 % , with the added convenience of once-daily dosing .
BACKGROUND	Drs. Modi , Lehmann , Walters , Fong , Christie , Roel , Nethery , and Reiser have been paid consultants to Alcon Research , Ltd. .
BACKGROUND	Ms. Sager is an employee of Alcon Research , Ltd. .
BACKGROUND	Drs. Tsorbatzoglou , Philipson , and Traverso have no financial or proprietary interest in any material or method mentioned .

###24228854
BACKGROUND	Many inpatients receive little or no rehabilitation on weekends .
BACKGROUND	Our aim was to determine what effect providing additional Saturday rehabilitation during inpatient rehabilitation had on functional independence , quality of life and length of stay compared to 5 days per week of rehabilitation .
METHODS	This was a multicenter , single-blind ( assessors ) randomized controlled trial with concealed allocation and 12-month follow-up conducted in two publically funded metropolitan inpatient rehabilitation facilities in Melbourne , Australia .
METHODS	Patients were eligible if they were adults ( aged 18 years ) admitted for rehabilitation for any orthopedic , neurological or other disabling conditions excluding those admitted for slow stream rehabilitation/geriatric evaluation and management .
METHODS	Participants were randomly allocated to usual care Monday to Friday rehabilitation ( control ) or to Monday to Saturday rehabilitation ( intervention ) .
METHODS	The additional Saturday rehabilitation comprised physiotherapy and occupational therapy .
METHODS	The primary outcomes were functional independence ( functional independence measure ( FIM ) ; measured on an 18 to 126 point scale ) , health-related quality of life ( EQ-5D utility index ; measured on a 0 to 1 scale , and EQ-5D visual analog scale ; measured on a 0 to 100 scale ) , and patient length of stay .
METHODS	Outcome measures were assessed on admission , discharge ( primary endpoint ) , and at 6 and 12 months post discharge .
RESULTS	We randomly assigned 996 adults ( mean ( SD ) age 74 ( 13 ) years ) to Monday to Saturday rehabilitation ( n = 496 ) or usual care Monday to Friday rehabilitation ( n = 500 ) .
RESULTS	Relative to admission scores , intervention group participants had higher functional independence ( mean difference ( MD ) 2.3 , 95 % confidence interval ( CI ) 0.5 to 4.1 , P = 0.01 ) and health-related quality of life ( MD 0.04 , 95 % CI 0.01 to 0.07 , P = 0.009 ) on discharge and may have had a shorter length of stay by 2 days ( 95 % CI 0 to 4 , P = 0.1 ) when compared to control group participants .
RESULTS	Intervention group participants were 17 % more likely to have achieved a clinically significant change in functional independence of 22 FIM points or more ( risk ratio ( RR ) 1.17 , 95 % CI 1.03 to 1.34 ) and 18 % more likely to have achieved a clinically significant change in health-related quality of life ( RR 1.18 , 95 % CI 1.04 to 1.34 ) on discharge compared to the control group .
RESULTS	There was some maintenance of effect for functional independence and health-related quality of life at 6-month follow-up but not at 12-month follow-up .
RESULTS	There was no difference in the number of adverse events between the groups ( incidence rate ratio = 0.81 , 95 % CI 0.61 to 1.08 ) .
CONCLUSIONS	Providing an additional day of rehabilitation improved functional independence and health-related quality of life at discharge and may have reduced length of stay for patients receiving inpatient rehabilitation .
BACKGROUND	Australian and New Zealand Clinical Trials Registry ACTRN12609000973213 Please see related commentary : http://www.biomedcentral.com/10.1186/1741-7015-11-199 .

###24491074
OBJECTIVE	The Resourceful Adolescent Program ( RAP ) is a universal , school-based intervention that has been found to produce small to medium effects in the reduction of adolescent depressive symptoms .
OBJECTIVE	In the present study , we evaluated the effectiveness of a friendship-building skills program -- the Peer Interpersonal Relatedness ( PIR ) program -- in producing larger effects when used in conjunction with RAP .
METHODS	A cluster-randomized controlled trial was used to assign whole classrooms of adolescent participants recruited from Sydney secondary schools to 1 of 3 conditions : ( a ) RAP-PIR , ( b ) RAP-placebo , or ( c ) assessment-only waiting-list control .
METHODS	Hierarchical linear modeling ( HLM ) was used to analyze the data .
RESULTS	Across the intervention period , RAP did not significantly reduce depressive symptoms relative to those students not receiving this intervention .
RESULTS	RAP followed by PIR did significantly reduce depressive symptoms relative to those students not receiving PIR .
RESULTS	Across the 12-month follow-up , the between-group reductions in depressive symptoms were no longer significant .
RESULTS	At follow-up , participants in the RAP-PIR condition had achieved significant increases in their school-related life satisfaction and significant increases in social functioning with peers relative to their peers in the other conditions .
CONCLUSIONS	The study provides preliminary support for the effectiveness of the PIR program in reducing depressive symptoms when used alongside RAP in the short term and in improving social adjustment and school-related life satisfaction in the longer term .
CONCLUSIONS	Given the importance of social adjustment in adolescent mental well-being , the PIR program represents a potentially important addition to the prevention of depression in youth .

###24709995
OBJECTIVE	It has been proposed that in the same way that conflict between vestibular and visual inputs leads to motion sickness , conflict between motor commands and sensory information associated with these commands may contribute to some chronic pain states .
OBJECTIVE	Attempts to test this hypothesis by artificially inducing a state of sensorimotor incongruence and assessing self-reported pain have yielded equivocal results .
OBJECTIVE	To help clarify the effect sensorimotor incongruence has on pain we investigated the effect of moving in an environment of induced incongruence on pressure pain thresholds ( PPT ) and the pain experienced immediately on completion of PPT testing .
METHODS	Thirty-five healthy subjects performed synchronous and asynchronous upper-limb movements with and without mirror visual feedback in random order .
METHODS	We measured PPT over the elbow and the pain evoked by testing .
METHODS	Generalised linear mixed-models were performed for each outcome .
METHODS	Condition ( four levels ) and baseline values for each outcome were within-subject factors .
RESULTS	There was no effect of condition on PPT ( p = 0.887 ) or pressure-evoked pain ( p = 0.771 ) .
RESULTS	A sensitivity analysis using only the first PPT measure after each condition confirmed the result ( p = 0.867 ) .
CONCLUSIONS	Inducing a state of movement related sensorimotor incongruence in the upper-limb of healthy volunteers does not influence PPT , nor the pain evoked by testing .
CONCLUSIONS	We found no evidence that sensorimotor incongruence upregulates the nociceptive system in healthy volunteers .

###25170535
OBJECTIVE	The aim of this study was to evaluate the safety and efficacy of retropubic ( RP ) or transobturator ( TO ) midurethral slings ( MUS ) in a prospective randomized cohort of Turkish women .
METHODS	A total of 54 women with urodynamic stress urinary incontinence ( SUI ) were randomized to undergo either RP or TO MUS between August 2006 and February 2013 in a tertiary referral center by a single surgeon .
METHODS	All patients had history , physical examination , urodynamic evaluation and quality of life assessments .
METHODS	The validated Turkish versions of the SEAPI , ICIQ-SF and OAB-V8 questionnaires were used .
METHODS	The Advantage RP and the Obtryx TO MUS Systems were used for all RP and TO procedures .
RESULTS	Twenty-seven patients were randomized to each group .
RESULTS	The median follow-up was 48.5 21.8 months .
RESULTS	The median hospital stay was 24.0 4.8 h and median operative time was 35.0 19.9 min .
RESULTS	The overall objective and subjective cure rates were 92.6 and 79.6 % , respectively .
RESULTS	The quality of life of all patients significantly increased after the operation compared to their preoperative status .
RESULTS	Patients with a poorer subjective cure rate were those with mixed urinary incontinence , whose preoperative SEAPI and OAB-V8 scores were significantly higher .
CONCLUSIONS	MUS surgery is highly effective and could safely be performed in a cohort of Turkish women with SUI in subspecialty centers by experienced surgeons .
CONCLUSIONS	There is no significant difference between RP or TO applications in terms of safety and efficacy .
CONCLUSIONS	Further studies with long-term follow-up data are required .

###24725445
OBJECTIVE	Pharmacokinetics and bioequivalence of 300 mg irbesartan tablets were studied in 26 healthy Thai male volunteers .
METHODS	A single oral dose of one 300 mg tablet of the test product and the reference product was given to each volunteer according to a randomized two-way crossover design with 1-week wash out period .
METHODS	Blood samples were collected at predetermined time intervals until 72 hours post dose and irbesartan concentration was quantified with a validated HPLC method .
METHODS	Individual plasma irbesartan concentration-time profile was analyzed for pharmacokinetic parameters .
RESULTS	Maximum plasma concentrations ( Cmax ) of 3,617.19 and 3,295.77 ng/mL for test and reference , respectively , were achieved .
RESULTS	Areas under the plasma concentration-time curve ; AUC0-t and AUC0 - were 15,304.65 and 15,638.90 ngh/mL for test and 15,389.21 and 15,730.34 ngh/mL for reference .
RESULTS	The median tmax was 1.50 hours and 1.25 hours for test and reference , respectively .
RESULTS	Plasma elimination half-lives ( t1/2 ) were 7.35 hours and 8.09 hours for test and reference , respectively .
RESULTS	Primary pharmacokinetic parameters Cmax , AUC0-t , and AUC0 - were tested parametrically by analysis of variance ( ANOVA ) , and it revealed no statistically significant difference ( defined as p < 0.05 ) between the corresponding Cmax , AUC0-t , and AUC0 - with respect to sequence , volunteers , period and formulation .
RESULTS	The 90 % confidence intervals for the ratio of test and reference product of the parameters Cmax , AUC0-t , and AUC0 - were within 80 - 125 % ( 100.13 - 121.40 % for Cmax , 90.83 - 106.86 % for AUC0-t and 91.11 - 106.55 % for AUC0 - ) .
CONCLUSIONS	The two products were bioequivalent in terms of both rate and extent of drug absorption into systemic circulation .

###24807871
OBJECTIVE	To evaluate the efficacy of maintenance therapy with oral micronized progesterone ( OMP ) for prolongation of pregnancy in cases of arrested preterm labor .
METHODS	Ninety women at 24-34weeks of singleton pregnancy with intact membranes and arrested preterm labor were randomly allocated to receive OMP ( n = 45 ) or placebo ( n = 45 ) daily until 37weeks or delivery , whichever was earlier .
METHODS	Outcome parameters were compared using Student t test , ( 2 ) test , Fisher exact test , and log-rank ( 2 ) test .
RESULTS	OMP significantly prolonged the latency period ( 33.2922.16 vs 23.0715.42 days ; P = 0.013 ) .
RESULTS	Log-rank analysis revealed a significant difference in mean time to delivery between the 2 groups ( P = 0.014 ) .
RESULTS	There were significantly fewer preterm births ( 33 % vs 58 % ; P = 0.034 ) and low birth weight neonates ( 37 % vs 64 % ; P = 0.017 ) , and significantly higher mean birth weight ( 2.440.58 vs 2.140.47 kg ; P = 0.009 ) in the OMP group .
RESULTS	Perinatal outcomes and adverse effects were similar in the 2 groups .
CONCLUSIONS	Maintenance tocolysis with OMP significantly prolonged pregnancy and decreased the number of preterm births .
CONCLUSIONS	Clinical Trial Registry of India : CTRI/2011/10 / 002043 .

###25646201
OBJECTIVE	Propofol is commonly used in pediatric sedation , which may cause hypotension during induction .
OBJECTIVE	Our goal was to determine the effect of a preinduction 20-mL/kg isotonic fluid bolus on propofol-induced hypotension , assess clinical signs of hypoperfusion during hypotension , and evaluate for age-related propofol dosing differences .
METHODS	This prospective , randomized , controlled , nonblinded study was conducted at Children 's Hospital of Illinois .
METHODS	Patients were children 6 to 60 months of age who needed sedation for MRI or auditory brainstem-evoked response testing .
METHODS	The treatment group received a preinduction 20-mL/kg isotonic saline bolus before procedure initiation .
METHODS	Patients were continuously monitored via cardiorespiratory monitor with pulse oximetry and end-tidal carbon dioxide measurements .
METHODS	Cardiovascular indices and clinical signs of hypoperfusion were compared between groups , and propofol dosing differences were compared between age groups .
RESULTS	One hundred twenty-six patients were randomly assigned to treatment ( n = 52 ) or control ( n = 74 ) conditions .
RESULTS	Twelve patients in the treatment group and 14 patients in the control group experienced postinduction hypotension , as defined by the Pediatric Advanced Life Support guidelines .
RESULTS	One patient in each group was given volume resuscitation when blood pressure did not improve after a reduction in the propofol infusion rate .
RESULTS	No hypotensive patients had physical signs of hypoperfusion , and patients1 year of age needed significantly more propofol .
CONCLUSIONS	A 20-mL/kg preinduction isotonic saline bolus does not prevent propofol-induced hypotension .
CONCLUSIONS	No clinical signs of hypoperfusion were noted with induced hypotension , and infants12 months old need significantly more propofol per kilogram for procedures .

###25288035
OBJECTIVE	We examined contraceptive use and dual protection in the postpartum period in a Prevention of Mother to Child Transmission population and whether it varied by HIV status .
METHODS	Data are from a prospective study , the South Africa HIV Antenatal Post-test Support Study .
METHODS	Pregnant participants were recruited from a government clinic in an urban township , and the analytic sample was 821 .
METHODS	Following enrollment , participants were tested for HIV and administered a questionnaire at baseline and 14 weeks postpartum .
METHODS	We used generalized linear regression models to examine HIV status and use of modern contraceptives at 14 weeks .
RESULTS	The risk ratio of condom use at 14 weeks postpartum was 1.66 [ 95 % confidence interval ( CI ) : 1.36-2 .02 ] for HIV-positive compared to HIV-negative women .
RESULTS	The risk ratio for dual protection ( use of a condom and a hormonal method ) was 1.96 ( 95 % CI : 1.39-2 .79 ) at 14 weeks for HIV-positive compared to HIV-negative women .
CONCLUSIONS	HIV positive status may be a motivating factor for women to use condoms and dual protection .
CONCLUSIONS	In this setting where HIV is highly prevalent , it is ever more important that women control the timing and limiting of births so as to preserve the health of the mother and child .
CONCLUSIONS	HIV status may be an important motivating behavioral factor for women to use contraceptives and dual protection in the postpartum period .

###24755382
OBJECTIVE	The INSPIRON-I trial is a first-in-man evaluation of the safety and efficacy of the Inspiron drug-eluting stent , a sirolimus-eluting stent with abluminal biodegradable polymer coating and thin cobalt-chromium alloy .
RESULTS	This is a randomised , multicentre comparison between Inspiron and a stent with the same metallic structure but without polymer coating or drug elution ( Cronus ) .
RESULTS	The primary objective was to evaluate the in-segment late loss ( LLL ) at six months .
RESULTS	Secondary endpoints included percent in-stent obstruction as measured by intravascular ultrasound ( IVUS ) at six months and major adverse cardiac events ( MACE ) .
RESULTS	Fifty-eight patients were enrolled ( 60 lesions ) , 39 for Inspiron and 19 for Cronus .
RESULTS	Baseline clinical and angiographic characteristics of both groups were similar .
RESULTS	At six months , the in-segment LLL was reduced in the Inspiron group compared to the control group ( 0.190.16 mm vs. 0.580.4 mm , respectively ; p < 0.001 ) , as well as the percent neointimal obstruction ( 7.87.1 % vs. 26.511.4 % ; p < 0.001 ) .
RESULTS	At two-year follow-up , incidence of MACE was similar between groups ( 7.9 vs. 21.1 % , respectively ; p = 0.20 ) , with lower target lesion revascularisation for Inspiron ( 0 vs. 21.1 % , respectively ; p = 0.01 ) and no stent thrombosis .
CONCLUSIONS	Sirolimus eluted from an abluminal biodegradable polymer on a cobalt-chromium alloy proved effective in reducing restenosis at six months .

###24905107
BACKGROUND	Chronic liver disease leads to fibrosis and cirrhosis of the liver .
BACKGROUND	This may , in turn , result in chronic liver failure or the development of hepatocellular carcinoma ( HCC ) .
BACKGROUND	Main risk factors for chronic liver disease are viral hepatitis and alcoholism .
BACKGROUND	The present study assessed a randomly selected population in southern Germany for risk factors for chronic liver disease such as fatty liver disease , viral hepatis infection and life-style factors .
BACKGROUND	In addition , the potential association with elevated liver enzymes was investigated .
METHODS	A total of 2256 subjects ( 1182 females , 1074 males ) , aged 18 - 65 years , participated in the study .
METHODS	Each subject underwent a standardized ultrasound examination , and anthropometric and biochemical assessments .
METHODS	Test subjects were randomly selected from the general population of a town in southwestern Germany .
METHODS	Data were acquired from November to December 2002 without further follow-up .
RESULTS	Several factors were found to be associated with chronic liver disease in the study population .
RESULTS	Alcohol consumption > 20 g/d was seen in 18.1 % ( n = 409 ) .
RESULTS	Metabolic syndrome was diagnosed in 5.9 % ( n = 132 ) .
RESULTS	The number of people with a BMI greater than 25 kg/m ( 2 ) was 45.1 % ( n = 1017 ) .
RESULTS	The prevalence of subjects with chronic hepatitis B was 0.7 % ( n = 15 ) , that of anti-HCV positive patients , 0.6 % ( n = 15 ) .
RESULTS	Elevated gGT was seen in 10.4 % ( n = 14 ) of the patients .
RESULTS	Prevalence of hepatic steatosis was 25.0 % ( n = 564 ) .
CONCLUSIONS	Many cases of chronic liver disease could be prevented by healthy nutrition , optimized medical treatment of associated disorders , and prevention strategies such as routine vaccination , in particular , against hepatitis B virus ( HBV ) .

###24416723
BACKGROUND	Helicobacter pylori infection is an emerging health concern to some northern Canadian Aboriginal communities and their clinicians .
BACKGROUND	Clinicians in the north perceive H. pylori infection to be a major clinical problem because they find H. pylori infection in many patients evaluated for common stomach complaints , leading to frequent demand for treatment , which often fails .
BACKGROUND	Moreover , public health authorities identified the need for information to develop locally appropriate H. pylori control strategies .
BACKGROUND	We described adherence and identified barriers to completing treatment among H. pylori-positive participants in a community-based project inspired by local concerns about H. pylori infection risks .
METHODS	In 2008 , 110 H. pylori-positive participants ( diagnosed by a breath test , histopathology and/or culture ) of the Aklavik H. pylori project were randomised to standard-of-care or sequential treatment .
METHODS	We ascertained adherence by interviewing participants using a structured questionnaire .
METHODS	We estimated adherence frequencies as the proportion of participants who reported taking either 100 % of doses ( perfect adherence ) or 80 % of doses ( good adherence ) .
METHODS	To compare the proportion with perfect or good adherence in subgroups , we report proportion differences and 95 % confidence intervals ( CI ) .
RESULTS	Of 87 participants who were interviewed , 64 % reported perfect adherence and 80 % reported good adherence .
RESULTS	We observed more frequent perfect adherence for : standard therapy ( 67 % ) versus sequential ( 62 % ) ; males ( 76 % ) versus females ( 52 % ) ; participants 40-77 years ( 79 % ) versus 17-39 ( 50 % ) .
RESULTS	Proportion differences were 5 % ( CI : -15 , 25 ) for standard versus sequential therapy ; 23 % ( CI : 4 , 43 ) for male versus female ; and 29 % ( CI : 10 , 48 ) for 40-77 versus 15-39 years for perfect adherence .
RESULTS	Of the 29 participants who reported poor adherence ( < 80 % of doses taken ) , the following barriers to treatment were reported : changed mind about taking treatment ( 24 % ) , consumption of alcoholic beverages ( 18 % ) , nausea ( 18 % ) , forgetfulness ( 12 % ) , stomach pain ( 12 % ) , difficulty in swallowing pills ( 6 % ) , no reason ( 6 % ) or bad taste of the pills ( 6 % ) .
CONCLUSIONS	This analysis suggests that adherence to treatment for eliminating H. pyori infection may vary by regimen and may be influenced by socio-demographic factors .
CONCLUSIONS	These findings add to the small body of evidence pertaining to adherence to H. pylori treatment in Arctic Aboriginal communities .
CONCLUSIONS	On-going research in additional northern Canadian communities will accumulate data for developing recommendations to improve adherence for treatment to eliminate H. pylori infection .

###24372968
BACKGROUND	Clinical indications for hydroxyethyl starches ( HES ) in horses include rapid plasma volume expansion and oncotic support during periods of hypoproteinaemia .
BACKGROUND	Side effects such as coagulopathies associated with HES administration pose limitations to their use in veterinary medicine .
BACKGROUND	In man , tetrastarch ( 130/0 .4 ) has demonstrated less profound effects on coagulation compared with first - and second-generation HES .
OBJECTIVE	To evaluate the haemostatic and oncotic effects of tetrastarch ( 130/0 .4 ) administered at 10 , 20 and 40ml/kg bwt in healthy horses .
METHODS	Randomised crossover experiment .
METHODS	Tetrastarch ( 130/0 .4 ) was administered to 6 healthy pony mares at 10 , 20 and 40ml/kg bwt with a 2-week washout period .
METHODS	Packed cell volume , plasma total solids , colloid osmotic pressure ( COP ) , platelet count and thromboelastography ( TEG ) were measured at baseline , immediately after infusion ( 0h ) , and 1 , 6 , 12 , 24 , 48 and 96h after tetrastarch infusion .
RESULTS	All TEG variables remained within normal reference ranges in all 3 treatment groups .
RESULTS	Administration of tetrastarch at 40ml/kg bwt resulted in a prolonged K-time ( P = 0.049 ) at 6h post infusion , and decreased maximum amplitude at 0 ( P < 0.001 ) , 1 ( P = 0.022 ) , 6 ( P = 0.006 ) , 24 ( P < 0.001 ) and 48h ( P = 0.013 ) post infusion compared with baseline .
RESULTS	Administration of tetrastarch increased mean COP values above baseline in all 3 treatment groups , persisting to 24 , 6 and 48h for the 10 , 20 and 40ml/kg bwt doses , respectively .
CONCLUSIONS	Although still within established reference ranges , compared with lower dosages , the administration of 40ml/kg bwt tetrastarch ( 130/0 .4 ) is more likely to induce changes in coagulation as measured by TEG .
CONCLUSIONS	Tetrastarch increased COP at all dosages evaluated in healthy horses .
CONCLUSIONS	Tetrastarch ( 130/0 .4 ) at 10 and 20ml/kg bwt has potential as a synthetic colloid for resuscitation and provision of oncotic support in horses .

###24579274
OBJECTIVE	To evaluate the 30-month clinical performance of a nanofilled-resin composite with or without glass-fiber layering in restorations of large cavities in posterior teeth of children .
METHODS	A total of 71 restorations were placed in permanent molar teeth of 47 children ( mean age 10.9 years ) with ( FRC ; n = 35 ) or without ( RC ; n = 36 ) fiber layering .
METHODS	One operator placed all restorations .
METHODS	Restorations were evaluated according to the USPHS modified-Ryge criteria at baseline , 6 , 12 , 18 , 24 , and 30 months .
METHODS	The data were analyzed using Fisher 's exact and chi-square tests and outcomes were compared using the Cochran-Q test ( p < 0.05 ) .
RESULTS	The 30-month survival rates of the restorations were 97 % and 97.1 % in the RC and FRC groups , respectively .
RESULTS	Nanofilled-resin restorations with or without glass fiber-layering showed similarly high clinical performance .
RESULTS	No differences were detected between the evaluated criteria when comparing baseline with any of the evaluation periods ( p < 0.05 ) .
RESULTS	After 30 months there were no secondary caries , change in anatomical form or postoperative sensitivity .
RESULTS	Only minor changes for marginal adaptation , marginal discoloration , color match and surface texture were observed .
CONCLUSIONS	It was concluded that nanofilled-resin composite applied with or without glass-fiber layering showed similar and good results in large cavities of posterior permanent teeth in children over a 30-month period .

###25070271
BACKGROUND	Sitting time ( ST ) , a form of sedentary behavior , has been identified as a highly prevalent risk factor for multiple sclerosis ( MS ) - related morbidity .
BACKGROUND	There is limited information on the efficacy of behavioral interventions for reducing ST in persons with MS.
OBJECTIVE	To examine the efficacy of a behavioral intervention for reducing ST in persons with MS in a pilot RCT .
METHODS	Seventy MS patients were randomly assigned to intervention and waitlist control conditions .
METHODS	The behavioral intervention was delivered April-September 2012 via the Internet and consisted of a dedicated website and one-on-one Skype video chats that taught participants the skills , techniques , and strategies for reducing sedentary behavior based on social cognitive theory .
METHODS	ST was measured by questions on the abbreviated International Physical Activity Questionnaire ( IPAQ ) before and after the 6-month RCT .
METHODS	Data were analyzed in SPSS , version 21.0 in March 2014 .
RESULTS	ANCOVA was performed on post-intervention scores controlling for pre-intervention values using an intent-to-treat analysis .
RESULTS	The group main effect was statistically significant ( F [ 1 , 67 ] = 4.03 , p < 0.05 , = 0.06 ) and yielded a parameter estimate of 98.9 ( SE = 49.3 , t = 2.01 , p < 0.05 ) .
RESULTS	The adjusted mean scores for intervention and control groups were 429.2 ( 201.2 ) and 528.2 ( 200.7 ) minutes of ST , respectively ( d = 0.49 ) .
CONCLUSIONS	We provide the first data on the efficacy of a behavioral intervention for reducing ST in MS patients .
CONCLUSIONS	This highlights the importance of designing and testing the effect of behavioral interventions that reduce ST on secondary outcomes such as function , symptoms , quality of life , and health status in persons with MS.

###24886619
BACKGROUND	The parallel-group randomized active-controlled clinical study was conducted to compare the effectiveness of two in-hospital range of motion ( ROM ) exercise programs following total knee arthroplasty ( TKA ) .
BACKGROUND	Continuous passive motion ( CPM ) is frequently used to increase ROM and improve postoperative recovery despite little conclusive scientific evidence .
BACKGROUND	In contrast , a new active sling-based ROM therapy requires the activation of the knee joint muscles and dynamic joint stabilization .
BACKGROUND	It was hypothesized that higher demands on muscle strength and muscle coordination during sling exercise training ( ST ) might be advantageous for early recovery following TKA .
METHODS	A total of 125 patients undergoing primary TKA were assessed for eligibility .
METHODS	Thirty-eight patients were randomly assigned to receive ST or CPM ( control intervention ) during hospital stay .
METHODS	Patients were assessed before TKA for baseline measurement ( pretest ) , 1day before discharge ( posttest ) and 3months after TKA ( follow-up ) .
METHODS	The passive knee flexion range of motion ( pFL ) was the primary outcome measure .
METHODS	Secondary outcome measures included active knee flexion range of motion , active and passive knee extension ROM , static postural control , physical activity , pain , length of hospital stay as well as clinical , functional and quality-of-life outcomes ( SF-36 , HSS and WOMAC scores ) .
METHODS	Data were analyzed according to the intention-to-treat principle .
METHODS	Differences between the groups were tested for significance by the unpaired Student 's t test or an analysis of covariance ( ANCOVA ) adjusted for baseline , weight , sex , age , pain and physical activity .
RESULTS	A between-group difference could be determined at posttest .
RESULTS	The pFL was significantly higher by 6.0 ( 95 % CI 0.9 to 11.2 ; P = 0.022 ) in the ST group .
RESULTS	No difference between groups in pFL was documented at follow-up .
RESULTS	Furthermore , no significant differences could be observed for any secondary outcome measure at posttest and follow-up .
CONCLUSIONS	ST seems to have a clinically relevant beneficial short-term effect on pFL compared to CPM .
CONCLUSIONS	The results support the implementation of ST in rehabilitation programs following TKA .
METHODS	Therapy , level 2b .

###25063045
BACKGROUND	Small increases in mean serum creatinine ( SCr ) were observed in studies of rheumatoid arthritis patients during tofacitinib treatment .
BACKGROUND	These SCr changes were investigated and potential mechanisms explored .
METHODS	SCr values and renal adverse event data were pooled from five Phase 3 and two long-term extension ( LTE ) studies .
METHODS	Dose-response relationships and association with inflammation ( C-reactive protein ( CRP ) ) were explored using Phase 2 data and confirmed with Phase 3 data .
RESULTS	In Phase 3 , least squares mean SCr differences from placebo at Month 3 were 0.02 and 0.04 mg/dl for tofacitinib 5 and 10 mg twice daily ( BID ) ( P < 0.05 ) , respectively .
RESULTS	During Months 0 to 3 , confirmed SCr 33 % increases over baseline were reported in 17 ( 1.4 % ; 5 mg BID ) and 23 ( 1.9 % ; 10 mg BID ) patients .
RESULTS	Generally , elevations plateaued and remained within normal limits throughout Phase 3 and LTE studies .
RESULTS	Exposure-response modeling demonstrated small , reversible effects of tofacitinib on mean SCr , and significant ( P < 0.05 ) effects of CRP on model parameters .
RESULTS	Phase 3 data confirmed that patients with higher baseline CRP or greater CRP decreases following tofacitinib treatment had the largest increases in SCr .
RESULTS	Across Phase 3 and LTE studies , 22 tofacitinib-treated patients had clinical acute renal failure ( ARF ) , predominantly in the setting of concurrent serious illness .
CONCLUSIONS	Tofacitinib treatment was associated with small , reversible mean increases in SCr that plateaued early .
CONCLUSIONS	The mechanism behind these SCr changes remains unknown , but may involve effects of tofacitinib on inflammation .
CONCLUSIONS	ARF occurred infrequently , was associated with concurrent serious illness , and was unrelated to prior SCr increases .

###25794517
OBJECTIVE	To assess safety up to 1year of follow-up associated with prasugrel and clopidogrel use in a prospective cohort of patients with acute coronary syndromes ( ACS ) .
METHODS	Between 2009 and 2012 , 2286 patients invasively managed for ACS were enrolled in the multicentre Swiss ACS Bleeding Cohort , among whom 2148 patients received either prasugrel or clopidogrel according to current guidelines .
METHODS	Patients with ST-elevation myocardial infarction ( STEMI ) preferentially received prasugrel , while those with non-STEMI , a history of stroke or transient ischaemic attack , age 75years , or weight < 60kg received clopidogrel or reduced dose of prasugrel to comply with the prasugrel label .
RESULTS	After adjustment using propensity scores , the primary end point of clinically relevant bleeding events ( defined as the composite of Bleeding Academic Research Consortium , BARC , type 3 , 4 or 5 bleeding ) at 1year , occurred at a similar rate in both patient groups ( prasugrel/clopidogrel : 3.8 % / 5.5 % ) .
RESULTS	Stratified analyses in subgroups including patients with STEMI yielded a similar safety profile .
RESULTS	After adjusting for baseline variables , no relevant differences in major adverse cardiovascular and cerebrovascular events were observed at 1year ( prasugrel/clopidogrel : cardiac death 2.6 % / 4.2 % , myocardial infarction 2.7 % / 3.8 % , revascularisation 5.9 % / 6.7 % , stroke 1.0 % / 1.6 % ) .
RESULTS	Of note , this study was not designed to compare efficacy between prasugrel and clopidogrel .
CONCLUSIONS	In this large prospective ACS cohort , patients treated with prasugrel according to current guidelines ( ie , in patients without cerebrovascular disease , old age or underweight ) had a similar safety profile compared with patients treated with clopidogrel .
BACKGROUND	SPUM-ACS : NCT01000701 ; COMFORTABLE AMI : NCT00962416 .

###24996596
BACKGROUND	Smoking rates , and associated negative health outcomes , are disproportionately high among people with mental illness compared to the general population .
BACKGROUND	Smoke-free policies within mental health hospitals can positively impact on patients ' motivation and self-efficacy to address their smoking .
BACKGROUND	However , without post-discharge support , preadmission smoking behaviours typically resume .
BACKGROUND	This protocol describes a randomised controlled trial that aims to assess the efficacy of linking mental health inpatients to community-based smoking cessation supports upon discharge as a means of reducing smoking prevalence .
METHODS	Eight hundred participants with acute mental illness will be recruited into the randomised controlled trial whilst inpatients at one of four psychiatric inpatient facilities in the state of New South Wales , Australia .
METHODS	After completing a baseline interview , participants will be randomly allocated to receive either : ` Supported Care ' , a multimodal smoking cessation intervention ; or ` Normal Care ' , consisting of existing hospital care only .
METHODS	The ` Supported Care ' intervention will consist of a brief motivational interview and a package of self-help material for abstaining from smoking whilst in hospital , and , following discharge , 16 weeks of motivational telephone-based counselling , 12 weeks of free nicotine replacement therapy , and a referral to the Quitline .
METHODS	Data will be collected at 1 , 6 and 12 months post-discharge via computer-assisted telephone interview .
METHODS	The primary outcomes are abstinence from smoking ( 7-day point prevalence and prolonged cessation ) , and secondary outcomes comprise daily cigarette consumption , nicotine dependence , quit attempts , and readiness to change smoking behaviour .
CONCLUSIONS	If shown to be effective , the study will provide evidence in support of systemic changes in the provision of smoking cessation care to patients following discharge from psychiatric inpatient facilities .
BACKGROUND	Australian New Zealand Clinical Trials Registry ANZTCN : ACTRN12612001042831 .
BACKGROUND	Date registered : 28 September 2012 .

###25712847
OBJECTIVE	The aim was to evaluate the feasibility and safety of early chest tube removal after complete video-assisted thoracic lobectomy ( CVATL ) .
METHODS	Retrospective analysis was performed on effects of chest tube removal on patients with lung cancer after pulmonary lobectomy between November 2013 and October 2014.154 eligible patients included 97 cases for CVATL and 57 cases for open thoracic lobectomy .
METHODS	Patients with CVATL were divided randomly into experimental group ( EG ) and control group ( CG ) , in which 51 patients in EG had chest tube removal on the 2 nd day after operation ; 46 patients in CG had the tube removal when the drainage volume < 100 ml/day .
METHODS	Patients in open thoracic lobectomy group ( OG ) had the tubes removal as CG .
METHODS	The drainage volumes of the 1 st and 2 nd 24 h after operation , duration of chest tubes , cases of pain alleviation , and recurrent pleural effusions requiring reintervention were measured .
RESULTS	The average drainage volume of the 1 st 24 h after operation of CVATL group from EG and CG was significantly reduced than that in OG ( 260.41 ml vs. 353.16 ml , P < 0.001 ) .
RESULTS	The average drainage volume of the 2 nd 24 h after operation of CG was significantly reduced than that in OG ( 163.91 ml vs. 222.98 ml , P < 0.001 ) .
RESULTS	The average duration of chest tube of CG for 2.98 days showed significant different compared with OG for 3.81 days ( P < 0.001 ) .
RESULTS	Chest tube removal in CVATL group increased more chest pain alleviation than OG ( 80.4 % vs. 56.1 % , P = 0.001 ) .
RESULTS	The frequencies of recurrent pleural effusions requiring reintervention were 5.88 % ( 3/51 ) , 4.35 % ( 2/46 ) and 5.26 % ( 3/57 ) , respectively , which had no significant differences between three groups ( P = 1.000 ) .
CONCLUSIONS	Complete video-assisted thoracic lobectomy brings less drainage volume after operation .
CONCLUSIONS	Early removal of chest tube in CVATL shows feasible and safe and demonstrates that it may reduce postoperative pain and help fast recovery .

###25008206
OBJECTIVE	To determine the clinical effectiveness of an exercise programme on self-reported hand activity performance in people with hand osteoarthritis ( OA ) .
METHODS	In this randomized , controlled trial , participants with physician-confirmed hand OA were randomly allocated to a 12-week exercise intervention ( group - and home-based ) or usual care .
METHODS	The primary outcome was self-reported hand activity performance at 3 months measured by the Functional Index for Hand Osteoarthritis ( FIHOA ) and a patient-generated measure of disability , the Patient-Specific Functional Scale ( PSFS ) .
RESULTS	Of 130 randomized participants ( mean age 66 ( standard deviation ( SD ) 9 ) ; female 90 % ) , 120 ( 92 % ) and 119 ( 92 % ) completed the 3 - and 6-month follow-ups .
RESULTS	The adjusted mean difference for the exercise vs control group was -0.5 points ( 95 % confidence interval ( CI ) -1.6 , 0.6 ) for the FIHOA score ( 0-30 scale , 0 = best ) and 0.9 points ( 95 % CI 0.1 , 1.7 ) for the PSFS score ( 0-10 scale , 10 = best ) .
RESULTS	Small significant mean differences in favour of the intervention group were found for hand pain , hand stiffness and disease activity , whereas no mean differences were observed in hand dexterity or maximal grip strength .
RESULTS	A significantly larger proportion in the intervention ( 46 % ) vs control group ( 16 % ) fulfilled the Outcome Measures in Rheumatological Clinical Trials-Osteoarthritis Research Society International ( OMERACT-OARSI ) responder criteria at 3 months ( OR = 4.4 , 95 % CI 1.9 , 10.2 ) .
RESULTS	At the 6-month follow-up , there were no significant group differences in any outcome .
CONCLUSIONS	The exercise programme was well tolerated among people with hand OA , but resulted only in small , beneficial short-term improvements on self-reported measures and not on most performance-based tests .
CONCLUSIONS	Future studies should address optimal grip strength exercises and dosage .
BACKGROUND	ClinicalTrials.gov registration number : NCT01245842 .

###25351805
METHODS	Systemic inflammation , endothelial dysfunction , and oxidative stress are involved in the pathogenesis of the metabolic syndrome ( MetS ) .
METHODS	Epidemiological evidence supports an association between whole soy food consumption and reduced risk of cardiovascular disease ( CVD ) .
METHODS	The objective of this randomized , controlled , cross-over study was to evaluate the effects of soy nut consumption on inflammatory biomarkers and endothelial function and to assess whether isoflavone metabolism to secondary products , equol , and/or O-desmethylangolensin ( ODMA ) , modifies these responses .
RESULTS	n = 17 adults at cardiometabolic risk were randomly assigned to the order of two snack interventions , soy nuts , and macronutrient-matched control snack , for four weeks each , separated by a two week washout period .
RESULTS	Outcome measures included biomarkers of inflammation , oxidative stress , and glycemic control ( ELISA and clinical analyzers ) , endothelial function , and arterial stiffness ( peripheral arterial tonometry ( PAT ) ) , and isoflavone metabolites ( LC-MS/MS ) .
RESULTS	Results revealed that consuming soy nuts improved arterial stiffness as assessed by the augmentation index using PAT ( p = 0.03 ) , despite lack of improvement in inflammatory biomarkers .
RESULTS	Addition of equol and/or ODMA production status as covariates did not significantly change these results .
CONCLUSIONS	Soy nuts when added to a usual diet for one month provide some benefit on arterial stiffness in adults at cardiometabolic risk .

###24419119
OBJECTIVE	The addition of PCV ( procarbazine , lomustine , and vincristine ) chemotherapy to radiotherapy ( RT ) for patients with WHO grade 2 glioma improves progression-free survival ( PFS ) .
OBJECTIVE	The effect of therapy intensification on cognitive function ( CF ) remains a concern in this population with substantial long-term survival .
METHODS	A total of 251 patients with WHO grade 2 glioma age 40 years with any extent of resection or age < 40 years with subtotal resection/biopsy were randomly assigned to RT ( 54 Gy ) or RT plus PCV .
METHODS	We observed 111 patients age < 40 years with gross total resection .
METHODS	CF was assessed by Mini-Mental State Examination ( MMSE ) at baseline and years 1 , 2 , 3 , and 5 .
RESULTS	Overall , few patients experienced significant decline in MMSE score .
RESULTS	There were no significant differences in the proportion of patients experiencing MMSE score decline between the randomized study arms at any time point .
RESULTS	Both study arms experienced a significant gain in average MMSE score longitudinally over time , with no difference between arms .
CONCLUSIONS	The MMSE is a relatively insensitive tool , and subtle changes in CF may have been missed .
CONCLUSIONS	However , the addition of PCV to RT did not result in significantly higher rates of MMSE score decline than RT alone through 5 years of follow-up .
CONCLUSIONS	Patients in both randomly assigned arms experienced a statistically significant average MMSE score increase over time , with no difference between arms .
CONCLUSIONS	The addition of PCV chemotherapy to RT improves PFS without excessive CF detriment over RT alone for patients with low-grade glioma .

###25175099
BACKGROUND	With use of EGFR tyrosine-kinase inhibitor monotherapy for patients with activating EGFR mutation-positive non-small-cell lung cancer ( NSCLC ) , median progression-free survival has been extended to about 12 months .
BACKGROUND	Nevertheless , new strategies are needed to further extend progression-free survival and overall survival with acceptable toxicity and tolerability for this population .
BACKGROUND	We aimed to compare the efficacy and safety of the combination of erlotinib and bevacizumab compared with erlotinib alone in patients with non-squamous NSCLC with activating EGFR mutation-positive disease .
METHODS	In this open-label , randomised , multicentre , phase 2 study , patients from 30 centres across Japan with stage IIIB/IV or recurrent non-squamous NSCLC with activating EGFR mutations , Eastern Cooperative Oncology Group performance status 0 or 1 , and no previous chemotherapy for advanced disease received erlotinib 150 mg/day plus bevacizumab 15 mg/kg every 3 weeks or erlotinib 150 mg/day monotherapy as a first-line therapy until disease progression or unacceptable toxicity .
METHODS	The primary endpoint was progression-free survival , as determined by an independent review committee .
METHODS	Randomisation was done with a dynamic allocation method , and the analysis used a modified intention-to-treat approach , including all patients who received at least one dose of study treatment and had tumour assessment at least once after randomisation .
METHODS	This study is registered with the Japan Pharmaceutical Information Center , number JapicCTI-111390 .
RESULTS	Between Feb 21 , 2011 , and March 5 , 2012 , 154 patients were enrolled .
RESULTS	77 were randomly assigned to receive erlotinib and bevacizumab and 77 to erlotinib alone , of whom 75 patients in the erlotinib plus bevacizumab group and 77 in the erlotinib alone group were included in the efficacy analyses .
RESULTS	Median progression-free survival was 160 months ( 95 % CI 139-181 ) with erlotinib plus bevacizumab and 97 months ( 57-111 ) with erlotinib alone ( hazard ratio 054 , 95 % CI 036-079 ; log-rank test p = 00015 ) .
RESULTS	The most common grade 3 or worse adverse events were rash ( 19 [ 25 % ] patients in the erlotinib plus bevacizumab group vs 15 [ 19 % ] patients in the erlotinib alone group ) , hypertension ( 45 [ 60 % ] vs eight [ 10 % ] ) , and proteinuria ( six [ 8 % ] vs none ) .
RESULTS	Serious adverse events occurred at a similar frequency in both groups ( 18 [ 24 % ] patients in the erlotinib plus bevacizumab group and 19 [ 25 % ] patients in the erlotinib alone group ) .
CONCLUSIONS	Erlotinib plus bevacizumab combination could be a new first-line regimen in EGFR mutation-positive NSCLC .
CONCLUSIONS	Further investigation of the regimen is warranted .
BACKGROUND	Chugai Pharmaceutical Co Ltd. .

###24438748
BACKGROUND	Mitral regurgitant volume ( MRvol ) is an important index of the severity of mitral regurgitation ( MR ) , but MRvol measurement remains challenging .
BACKGROUND	With the development of probe technology and software , General Imaging 3D Quantification ( GI 3DQ ) allows the direct measurement of MR jet volume .
BACKGROUND	The aim of this study was to evaluate the feasibility and accuracy of MRvol by quantification of MR jet volume using GI 3DQ .
METHODS	Ninety-three patients were included , 61 with functional MR and 32 with mitral valve prolapse .
METHODS	Patients with MR were also divided into those with central MR ( n = 41 ) and those with eccentric MR ( n = 52 ) .
METHODS	MRvol was assessed using GI 3DQ and the proximal isovelocity surface area ( PISA ) method .
METHODS	MRvol using effective regurgitant orifice area by real-time three-dimensional echocardiography multiplied by the MR time-velocity integral was used as the reference method .
RESULTS	MRvol measured by GI 3DQ and the PISA method had good correlation with MRvol by the reference method .
RESULTS	A significant underestimation of MRvol using GI 3DQ and the PISA method was observed in the assessment of eccentric MR , but without a significant difference in the assessment of central MR.
CONCLUSIONS	Quantification of MRvol with GI 3DQ was feasible .
CONCLUSIONS	Quantification of central MRvol using this methodology is accurate compared with the reference method .
CONCLUSIONS	Quantification of MRvol with GI 3DQ has no significant difference from the currently recommended PISA method .

###24564746
BACKGROUND	The occipito-posterior ( OP ) fetal head position during the first stage of labour occurs in 10-34 % of cephalic presentations .
BACKGROUND	Most will spontaneous rotate in anterior position before delivery , but 5-8 % of all births will persist in OP position for the third stage of labour .
BACKGROUND	Previous observations have shown that this can lead to an increase of complications , such as an abnormally long labour , maternal and fetal exhaustion , instrumental delivery , severe perineal tears , and emergency caesarean section .
BACKGROUND	Usual care in the case of diagnosis of OP position is an expectant management .
BACKGROUND	However , maternal postural techniques have been reported to promote the anterior position of the fetal head for delivery .
BACKGROUND	A Cochrane review reported that these maternal positions are well accepted by women and reduce back pain .
BACKGROUND	However , the low sample size of included studies did not allow concluding on their efficacy on delivery outcomes , particularly those related to persistent OP position .
BACKGROUND	Our objective is to evaluate the efficacy of maternal position in the management of OP position during the first stage of labour .
METHODS	A randomised clinical trial is ongoing in the maternity unit of the Geneva University Hospitals , Geneva , Switzerland .
METHODS	The unit is the largest in Switzerland with 4,000 births/year .
METHODS	The trial will involve 438 women with a fetus in OP position , confirmed by sonography , during the first stage of the labour .
METHODS	The main outcome measure is the position of the fetal head , diagnosed by ultrasound one hour after randomisation .
CONCLUSIONS	It is important to evaluate the efficacy of maternal position to correct fetal OP position during the first stage of the labour .
CONCLUSIONS	Although these positions seem to be well accepted by women and appear easy to implement in the delivery room , the sample size of the last randomised clinical trial published in 2005 to evaluate this intervention had insufficient power to demonstrate clear evidence of effectiveness .
CONCLUSIONS	If the technique demonstrates efficacy , it would reduce the physical and psychological consequences of complications at birth related to persistent OP position .
BACKGROUND	ClinicalTrials.gov , http://www.clinicaltrials.gov: ( no .
BACKGROUND	NCT01291355 ) .

###25316486
BACKGROUND	Retroperitoneal soft tissue sarcomas ( RPS ) are rare tumors that include several well-defined histologic subtypes .
BACKGROUND	Although surgery is the mainstay of curative therapy , no universally accepted recommendations concerning the best management have been developed to date .
BACKGROUND	Optimization of the initial approach is critical for maximizing patient outcomes .
METHODS	An RPS Trans-Atlantic Working Group was established in 2013 .
METHODS	The primary aim was to evaluate the current evidence critically and to develop a consensus document on the approach to this difficult disease .
METHODS	The outcome applies to primary RPS that is nonvisceral in origin .
METHODS	The evaluation included sarcomas of major veins ( inferior vena cava , renal vein , ovarian/testicular vein ) , undifferentiated pleomorphic sarcoma of the psoas , and ureteric leiomyosarcoma ( LMS ) .
METHODS	It excluded desmoid , lipoma and angiomyolipoma , gastrointestinal stromal tumors , visceral sarcomas such as those arising from the gut or its mesentery , uterine LMS , prostatic sarcoma , paratesticular/spermatic cord sarcoma , Ewing 's sarcoma , alveolar/embryonal rhabdomyosarcoma , primitive peripheral neuro-ectodermal tumor , sarcoma arising from teratoma , carcinosarcoma , sarcomatoid carcinoma , clear cell sarcoma , radiation-induced sarcoma , paraganglioma , and malignant pheochromocytoma .
RESULTS	Management of RPS was evaluated from diagnosis to follow-up , and a level of evidence was attributed to each statement .
RESULTS	This rare and complex malignancy is best managed by an experienced multidisciplinary team in a specialized referral center .
RESULTS	The best chance of cure is at the time of primary presentation , and an individualized management plan should be made based on the statements included in this article .
CONCLUSIONS	International collaboration is critical for adding to the current knowledge .
CONCLUSIONS	A prospective registry will be set up .

###24559813
OBJECTIVE	To investigate the effects of Swedish massage with aromatic ginger oil ( SMGO ) on chronic low back pain and disability in older adults compared with traditional Thai massage ( TTM ) .
METHODS	Randomized controlled trial .
METHODS	Massage clinic in Ratchaburi province , Thailand .
METHODS	164 patients were screened ; 140 were eligible , and randomized to either SMGO ( n = 70 ) or TTM ( n = 70 ) .
METHODS	Trained staff provided participants with a 30-min SMGO or TTM twice a week for five weeks .
METHODS	The Visual Analogue Scale ( VAS ) assessed immediate effect ( after each massage ) and the short form McGill Pain Questionnaire ( MPQ ) assessed effectiveness of massage in short-term ( six weeks ) and long-term ( 15 weeks ) .
METHODS	Disability improvement was measured by the Owestry Disability Questionnaire ( ODQ ) at baseline , short - and long-term .
RESULTS	Both SMGO and TTM led to significant improvements in pain intensity ( p < 0.05 ) and disability ( p < 0.05 ) across the period of assessments , indicating immediate , short - and long-term effectiveness .
RESULTS	SMGO was more effective than TTM in reducing pain ( p = 0.04 ) and improving disability at short - and long-term assessments ( p = 0.04 ) .
CONCLUSIONS	These findings suggest that the integration of either SMGO or TTM therapy as additional options to provide holistic care to older people with chronic low back pain could be considered by health professionals .
CONCLUSIONS	Further research into the use of ginger as an adjunct to massage therapy , particularly TTM , is recommended .

###24472002
OBJECTIVE	To determine whether 1-week stenting of the pelvi-ureteric anastomosis of laparoscopic or robot-assisted pyeloplasty is as effective as 4-week stenting , based on their respective success rates .
METHODS	A total of 100 patients with pelvi-ureteric junction obstruction were treated by Anderson-Hynes pyeloplasty and the anastomosis was stented using a 6-F JJ catheter for either 1 week ( 1W series ) or 4 weeks ( 4W series ) , based on a randomisation protocol .
METHODS	Postoperative follow-up was performed at 3 months using intravenous urography ( IVU ) , at 6 months using diuretic renography and at 1 , 3 and 5 years using ultrasonography .
METHODS	Statistical analysis was performed using a one-sided Z-test , Pearsons 's chi-squared test and a Wilcoxon rank sum test .
RESULTS	The primary outcome measure , success rate , which was defined as no obstruction on IVU and diuretic renography , was 100 % in the 1W series and not inferior to the success rate of 98 % in the 4W series ( P = 0.006 ) .
RESULTS	The following secondary outcome measures were not significantly different between the 1W and the 4W series with regard to residual symptoms ( 10 vs 6 % ; P = 0.48 ) , rate of complications ( 4 vs 6 % ; P = 0.65 ) , need for synchronous robot-assisted pyelolithotomy ( 4 vs 8 % ; P = 0.47 ) , improvement in split renal function ( 1 vs 0 % ; P = 0.59 ) and duration of surgery ( 200 vs 192min ; P = 0.87 ) .
RESULTS	Only length of hospital stay was significantly different ; this was shorter in the 1W series ( 5 vs 6 days ; P = 0.01 ) .
CONCLUSIONS	Stenting of the pelvi-ureteric anastomosis after laparoscopic or robot-assisted pyeloplasty for 1 week is as effective as stenting for 4 weeks .
CONCLUSIONS	Both procedures , laparoscopic or robot-assisted pyeloplasty have an excellent success rate .

###24691332
BACKGROUND	We previously reported results of our on-line microsurgery training program , showing that residents who had access to our website significantly improved their cognitive and technical skills .
BACKGROUND	In this study , we report an objective means for expert evaluators to reliably rate trainees ' technical skills under the microscope , with the use of our novel global rating scale .
METHODS	`` Microsurgery Essentials '' ( http://smartmicrosurgery.com ) is our on-line training curriculum .
METHODS	Residents were randomly divided into 2 groups : 1 group reviewed this online resource and the other did not .
METHODS	Pre - and post-tests consisted of videotaped microsurgical sessions in which the trainee performed `` microsurgery '' on 3 different models : latex glove , penrose drain , and the dorsal vessel of a chicken foot .
METHODS	The SMaRT ( Stanford Microsurgery and Resident Training ) scale , consisting of 9 categories graded on a 5-point Likert scale , was used to assess the trainees .
METHODS	Results were analyzed with ANOVA and Student t test , with P less than 0.05 indicating statistical significance .
RESULTS	Seventeen residents participated in the study .
RESULTS	The SMaRT scale adequately differentiated the performance of more experienced senior residents ( PGY-4 to PGY-6 , total average score = 3.43 ) from less experienced junior residents ( PGY-1 to PGY-3 , total average score = 2.10 , P < 0.0001 ) .
RESULTS	Residents who viewed themselves as being confident received a higher score on the SMaRT scale ( average score 3.5 ) , compared to residents who were not as confident ( average score 2.1 ) ( P < 0.001 ) .
RESULTS	There were no significant differences in scoring among all 3 evaluators ( P > 0.05 ) .
RESULTS	Additionally , junior residents who had access to our website showed a significant increase in their graded technical performance by 0.7 points when compared to residents who did not have access to the website who showed an improvement of only 0.2 points ( P = 0.01 ) .
CONCLUSIONS	Our SMaRT scale is valid and reliable in assessing the microsurgical skills of residents and other trainees .
CONCLUSIONS	Current trainees are more likely to use self-directed on-line education because of its easy accessibility and interactive format .
CONCLUSIONS	Our global rating scale can help ensure residents are achieving appropriate technical milestones .

###24760603
OBJECTIVE	To determine the efficacy of timolol 0.1 % gel in preventing increased intraocular pressure ( IOP ) after uncomplicated cataract surgery .
METHODS	In this prospective , double-blinded , randomized study were enrolled 70 patients who underwent uncomplicated cataract surgery with phacoemulsification and intraocular lens implantation .
METHODS	After cataract surgery , 25 patients received a single instillation of timolol 0.1 % gel ( group A ) ; 20 a single instillation of timolol 0.5 % eyedrops ( group B ) ; and 25 no treatment ( group C ) .
METHODS	The IOP was measured before surgery ( T0 ) and 5 minutes ( T1 ) , 2 hours 30 minutes ( T2 ) , 4 hours 30 minutes ( T3 ) , and 24 hours 180 minutes after surgery ( T4 ) .
RESULTS	The patients in groups A and B had lower mean IOP values than those in group C at T2 , T3 , and T4 ; IOP was higher at T2 and T3 than at T1 in the control group .
RESULTS	The IOP spikes in group C were higher than those observed in groups A and B : at T2 , they were observed in 40 % of the patients in group A , 30 % in group B , and 76 % in group C ; and at T3 , in respectively 20 % , 10 % , and 68 % ; and at T4 , in respectively 4 % , 0 % , and 28 % .
CONCLUSIONS	Timolol 0.1 % gel is as effective as timolol 0.5 % eyedrops in reducing IOP and in limiting the occurrence of IOP spikes for up to 24 hours after phacoemulsification .

###24400967
OBJECTIVE	To evaluate the effects of a breastfeeding intervention on primiparous mothers ' breastfeeding self-efficacy , breastfeeding duration and exclusivity at 4 and 8 weeks postpartum .
BACKGROUND	Few studies have examined the effects of breastfeeding self-efficacy on improved breastfeeding outcomes among primiparous mothers in China .
METHODS	An experimental pre-test and posttest , two-group design was used in the study .
METHODS	A total of 74 participants were recruited to the study from a tertiary hospital in central China , from June-October 2012 .
METHODS	An individualized , standardized nursing intervention based on the Self-Efficacy Theory was delivered to enhance mothers ' breastfeeding self-efficacy , breastfeeding duration and exclusivity at 4 and 8 weeks postpartum .
METHODS	Participants were randomly assigned to an intervention or referent group .
METHODS	Participants in the intervention group received three individualized , self-efficacy-enhancing sessions .
METHODS	Participants in the referent group received standard care .
RESULTS	Participants in the intervention group showed significantly greater increases in breastfeeding self-efficacy , exclusivity and duration than participants in the control group at 4 and 8 weeks postpartum ( except for duration at 4 weeks ) .
RESULTS	High baseline breastfeeding self-efficacy predicted higher breastfeeding self-efficacy later and more exclusive breast-feeding .
CONCLUSIONS	The findings in this study suggest that intervention aimed at increasing self-efficacy has a significant impact on maternal breastfeeding self-efficacy and short-term breastfeeding outcomes .

###24382299
OBJECTIVE	To examine risk moderation of an alcohol intervention targeting parents and adolescents .
METHODS	A cluster randomized trial including 2937 Dutch early adolescents ( m = 12.68 years , SD = 0.51 ) and their parents randomized over four conditions : parent intervention , student intervention , combined parent-student intervention , and control group .
METHODS	152 classes of 19 high schools in The Netherlands ( 2006 ) .
METHODS	Moderators at baseline ( adolescent : gender , educational level and externalizing behavior ; parent : educational level and heavy alcohol use ) were used to examine the differential effects of the interventions on onset of ( heavy ) weekly drinking at 22-month follow-up .
RESULTS	The combined intervention effectively delayed the onset of weekly drinking in the general population of adolescents , and was particularly effective in delaying the onset of heavy weekly drinking in a higher-risk subsample of adolescents ( i.e. those attending lower levels of education and reporting higher levels of externalizing behavior ) .
CONCLUSIONS	Present and previous results have established the combined intervention to be universally effective in postponing weekly alcohol use among Dutch adolescents , with an added effect on postponing heavy weekly drinking in high risk subgroups .
CONCLUSIONS	Therefore , implementation of this intervention in the general population of schools in The Netherlands is advised .
BACKGROUND	NTR649 .

###24581015
BACKGROUND	Knowledge among critical care nurses and their adherence to evidence-based guidelines for preventing ventilator-associated pneumonia is reported to be low .
BACKGROUND	The aim of our study was to evaluate the effectiveness of human patient simulation ( HPS ) education in the nursing management of patients requiring mechanical ventilation .
METHODS	A prospective , parallel , randomized controlled trial with repeated measurements was conducted in a 22-bed adult mixed medical-surgical intensive care unit in Finland from February-October 2012 .
METHODS	Thirty critical care nurses were allocated evenly to intervention and control groups ( n = 15 each ) .
METHODS	The effectiveness of HPS education was evaluated through the validated Ventilator Bundle Questionnaire and Ventilator Bundle Observation Schedule at baseline and repeated twice-after the clinical and simulation settings , respectivley .
RESULTS	After HPS education , the average skill scores ( Ventilator Bundle Observation Schedule ) in the intervention group increased significantly ( 46.8 % -60.0 % of the total score ) in the final postintervention observation .
RESULTS	In the average skill scores , a linear mixed model identified significant time ( Pt < .001 ) and group ( P ( g ) = .03 ) differences and time-group interactions ( P ( t * g ) = .02 ) between the study groups after the HPS education .
RESULTS	In contrast , the model did not identify any significant change over time ( P ( t ) = .29 ) or time-group interactions ( P ( t ) = .69 ) between groups in average knowledge scores ( Ventilator Bundle Questionnaire ) .
CONCLUSIONS	Our study identified significant transfer of learned skills to clinical practice following HPS education but no influence on the level of participants ' factual knowledge .

###24433317
BACKGROUND	Immediate breast reconstruction with an expander is a reasonable option for properly selected patients .
BACKGROUND	After reconstruction , patients have severe postoperative pain , which responds poorly to opioids .
BACKGROUND	Our aim was to evaluate if continuous wound infusion of a local anaesthetic into the surgical wound reduces postoperative pain , consumption of opioids and incidence of chronic pain compared to standard intravenous piritramide after primary breast reconstruction in breast carcinoma patients .
METHODS	Altogether , 60 patients were enrolled in our study ; one half in the group with wound infusion of a local anaesthetic , and the other half in the standard ( piritramide ) group .
METHODS	Parameters measured included : pain intensity ( visual analogue scale ) , drug requirements , alertness , hospitalisation , side-effects and late complications .
METHODS	A p-value of < 0.05 was considered statistically significant .
RESULTS	In the recovery room , the test group reported less acute pain at rest ( P = 0.03 ) and at activity ( P = 0.01 ) , and on the day of the surgical procedure they reported less pain at activity ( P = 0.003 ) .
RESULTS	Consumption of piritramide and metoclopramide was lower in this group ( P < 0.0001 ) , but their alertness after the surgical procedure was higher compared to the standard group ( P < 0.001 ) .
RESULTS	After three months , the test group reported less chronic pain ( P = 0.01 ) .
CONCLUSIONS	After primary tissue expander breast reconstruction , wound infusion of a local anaesthetic significantly reduces acute pain and enables reduced opioid consumption , resulting in less postoperative sedation and reduced need for antiemetic drugs .
CONCLUSIONS	Wound infusion of a local anaesthetic reduces chronic pain .

###25082117
BACKGROUND	To explore whether poor initial insight during a first episode of mania with psychotic features was predictive of poor psychosocial and clinical outcomes at 18 months .
METHODS	Secondary analysis was performed on data collected during an 8-week RCT comparing the efficacy of olanzapine versus chlorpromazine as an adjunct to lithium , and at 18-month follow-up .
METHODS	74 participants were divided into three groups ( no insight , partial insight , and full insight ) according to the insight item from the Young Mania Rating Scale ( YMRS ) .
METHODS	Differences between these three groups were examined at baseline and at 18 months on measures of symptoms ( YMRS , HAMD-21 , and CGI-S ) , and social and occupational functioning ( SOFAS ) .
METHODS	Baseline differences between the three groups were determined using general linear models and chi-squared analyses .
METHODS	Group differences from baseline to 18-month follow-up were determined using repeated measures general linear models .
RESULTS	At baseline there were significant differences between the three insight groups in terms of mania and functioning , but at 18 months all groups had improved significantly in terms of psychopathology , mania , depression and social and occupational functioning .
RESULTS	There were no significant differences between the three groups at study completion with respect to these domains .
CONCLUSIONS	The study was limited by the lack of availability of a more detailed rating scale for insight , and it did not account for the duration of untreated psychosis ( DUI ) .
CONCLUSIONS	Poor initial insight during a first episode of mania with psychotic features does not predict poor clinical and psychosocial outcome at 18 months .

###24495415
BACKGROUND	New surgical techniques and devices have been described that decrease post-tonsillectomy morbidities .
BACKGROUND	This study aimed to compare the two most popular tonsillectomy techniques .
METHODS	Forty children underwent tonsillectomies using both the thermal welding and cold dissection techniques .
METHODS	In each patient , one side was removed with thermal welding and the other was removed with cold dissection .
RESULTS	There was a significant decrease in intra-operative blood loss , and the mean operation time was significantly lower on the thermal welding side compared with the cold dissection side .
RESULTS	On the cold dissection side , tissue healing ( i.e. the rate of complete tissue healing ) was better and less pain was reported compared with the thermal welding side .
RESULTS	However , there were no significant differences between the two techniques in terms of throat pain scores on the 1st , 3rd or 14th day post-operatively , or tissue healing scores on any of the post-operative days assessed .
CONCLUSIONS	Cold dissection resulted in better tissue healing and lower pain scores than thermal welding , but thermal welding was associated with less intra-operative blood loss and lower mean operation time than cold dissection .

###25369827
BACKGROUND	Several probiotic strains have been shown to enhance human resistance to infectious disease .
BACKGROUND	It is speculated that these strains may impose this effect by excretion of anti-microbial components , by competing with pathogens for intestinal nutrients and/or mucosal adhesion sites or modulating the immune system .
OBJECTIVE	A parallel , double-blind , placebo-controlled 4-week intervention was performed in healthy males , to study the effect of a blend of probiotic bacteria ( Lactobacillus helveticus Rosell-52 , Lactobacillus rhamnosus Rosell-11 , Bifidobacterium longum ssp .
OBJECTIVE	longum Rosell-175 ) and a probiotic yeast ( Saccharomyces cerevisiae var boulardii CNCM I-1079 ) on enterotoxigenic Escherichia coli ( ETEC ) challenge .
OBJECTIVE	Primary outcomes studied were fecal ETEC excretion and total fecal output per day .
METHODS	Subjects were randomized to the probiotic ( 5 10 ( 9 ) colony-forming units ( CFUs ) ; twice daily ; n = 30 ) or placebo group ( twice daily ; n = 30 ) .
METHODS	After 2 weeks , subjects were orally challenged with a live attenuated ETEC ( 3 10 ( 9 ) CFU ) , previously demonstrated to induce mild , short-lived symptoms of a foodborne infection .
METHODS	Before and after ETEC challenge , subjects collected 24h fecal samples .
METHODS	Compliance to study guidelines , stool consistency ( Bristol Stool Score ) , stool frequency , and frequency and severity of gastrointestinal ( GI ) complaints were recorded by the subjects on a Daily Record Questionnaire .
RESULTS	ETEC challenge induced a significant increase in fecal ETEC excretion in both groups .
RESULTS	However , a statistically significant increase in fecal output was only observed in the probiotic group .
RESULTS	ETEC challenge resulted in a decrease in the percentage of fecal dry weight , and an increase in reported Bristol Stool Score , stool frequency and GI complaints .
RESULTS	Dietary probiotics significantly decreased the percentage of fecal dry weight .
RESULTS	In addition , ETEC increased C-reactive protein , total secretory Immunoglobulin A ( IgA ) and Immunoglobulin G Colonization Factor Antigen II .
CONCLUSIONS	Dietary probiotics did not increase resistance to oral attenuated ETEC challenge in human subjects .

###24887490
OBJECTIVE	To investigate the impact of three different macular carotenoid formulations on macular pigment optical density and visual performance in subjects with early age-related macular degeneration .
METHODS	Fifty-two subjects were supplemented and followed for 12 months , 17 of them were in intervention Group 1 ( 20 mg/day lutein and 2 mg/day zeaxanthin ) ; 21 in Group 2 ( 10 mg/day meso-zeaxanthin , 10 mg/day lutein , and 2 mg/day zeaxanthin ) ; and 14 in Group 3 ( 17 mg/day meso-zeaxanthin , 3 mg/day lutein , and 2 mg/day zeaxanthin ) .
METHODS	The macular pigment optical density was measured using customized heterochromatic flicker photometry , and visual function was assessed using corrected distance visual acuity and by letter contrast sensitivity .
RESULTS	A statistically significant increase in the macular pigment optical density was observed at all measured eccentricities in Group 2 ( P 0.005 ) and in Group 3 ( P < 0.05 , for all ) , but only at 1.75 in Group 1 ( P = 0.018 ) .
RESULTS	Statistically significant ( P < 0.05 ) improvements in letter contrast sensitivity were seen at all spatial frequencies ( except 1.2 cycles per degree ) in Group 3 , and at low spatial frequencies in Groups 1 and 2 .
CONCLUSIONS	Augmentation of the macular pigment optical density across its spatial profile and enhancements in contrast sensitivity were best achieved after supplementation with a formulation containing high doses of meso-zeaxanthin in combination with lutein and zeaxanthin .

###24708554
BACKGROUND	In the PREDICT study , a randomised controlled trial comparing dexamethasone with prednisolone in patients with chronic inflammatory demyelinating polyradiculoneuropathy ( CIDP ) , almost a quarter of patients deteriorated soon after starting treatment .
BACKGROUND	The primary objective of this post-hoc analysis was to test the hypothesis that a focal demyelination pattern is associated with early deterioration after corticosteroid treatment and to explore whether various clinical characteristics are associated with deterioration after corticosteroid treatment .
METHODS	Clinical outcome was categorised into early deterioration and non-early deterioration .
METHODS	A neurophysiologist blinded for treatment outcome scored electrophysiological data into following categories : pure focal versus non-focal distribution of demyelination and no/minor versus moderate/severe sensory involvement .
METHODS	Additionally , we compared electrophysiological and clinical baseline parameters , with emphasis on previously reported possible associations .
RESULTS	Early deterioration was found in 7 out of 33 patients ( 21 % ) .
RESULTS	Ten patients had pure focal distribution of demyelination , of whom 5 had early deterioration ; 23 patients had non-focal distribution , of whom 2 had early deterioration ( p = 0.02 ) .
RESULTS	Higher mean median nerve sensory nerve conduction velocity ( SNCV ) was found in patients with early deterioration compared to patients with non-early deterioration ( 52.6 and respectively 40.8 m/s , p = 0.02 ) .
CONCLUSIONS	Pure focal distribution of demyelination and lesser sensory electrophysiological abnormalities may be associated with early deterioration in CIDP patients treated with corticosteroids .

###24663049
OBJECTIVE	Although azacitidine ( AZA ) improves survival in patients with high-risk myelodysplastic syndrome , the overall response remains approximately 50 % .
OBJECTIVE	Entinostat is a histone deacetylase inhibitor that has been combined with AZA with significant clinical activity in a previous phase I dose finding study .
METHODS	Open label phase II randomized trial comparing AZA 50 mg/m ( 2 ) / d given for 10 days entinostat 4 mg/m ( 2 ) / d day 3 and day 10 .
METHODS	All subtypes of myelodysplasia , chronic myelomonocytic leukemia , and acute myeloid leukemia with myelodysplasia-related changes were eligible for the study .
METHODS	The primary objective was the rate of hematologic normalization ( HN ; complete remission + partial remission + trilineage hematological improvement ) .
RESULTS	One hundred forty-nine patients were analyzed , including 97 patients with myelodysplastic syndrome and 52 patients with acute myeloid leukemia .
RESULTS	In the AZA group , 32 % ( 95 % CI , 22 % to 44 % ) experienced HN and 27 % ( 95 % CI , 17 % to 39 % ) in the AZA + entinostat group .
RESULTS	Both arms exceeded the HN rate of historical control ( Cancer and Leukemia Group B 9221 trial ) , but only the AZA group fulfilled the primary objective of the study .
RESULTS	Rates of overall hematologic response were 46 % and 44 % , respectively .
RESULTS	Median overall survivals were 18 months for the AZA group and 13 months for the AZA + entinostat group .
RESULTS	The combination arm led to less demethylation compared with the monotherapy arm , suggesting pharmacodynamic antagonism .
CONCLUSIONS	Addition of entinostat to AZA did not increase clinical response as defined by the protocol and was associated with pharmacodynamic antagonism .
CONCLUSIONS	However , the prolonged administration of AZA by itself seems to increase HN rate compared with standard dosing and warrants additional investigation .

###24418726
BACKGROUND	Periodic breathing ( PB ) during sleep and exercise in heart failure ( HF ) is related to respiratory acid-base status , CO2 chemosensitivity , and temporal dynamics of CO2 and O2 sensing .
BACKGROUND	We studied inhaled CO2 and acetazolamide to alter these factors and reduce PB .
RESULTS	We measured expired and arterial gases and PB amplitude and duration in 20 HF patients during exercise before and after acetazolamide given acutely ( 500 mg intravenously ) and prolonged ( 24 hours , 2 g orally ) , and we performed overnight polysomnography .
RESULTS	We studied CO2 inhalation ( 1 % -2 % ) during constant workload exercise .
RESULTS	PB disappeared in 19/20 and 2/7 patients during 2 % and 1 % CO2 .
RESULTS	No changes in cardiorespiratory parameters were observed after acute acetazolamide .
RESULTS	With prolonged acetazolamide at rest : ventilation +2.04 4.0 L/min ( P = .001 ) , tidal volume +0.11 1.13 L ( P = .003 ) , respiratory rate +1.24 4.63 breaths/min ( NS ) , end-tidal PO2 +4.62 2.43 mm Hg ( P = .001 ) , and end-tidal PCO2 -2.59 9.7 mm Hg ( P < .001 ) .
RESULTS	At maximum exercise : Watts -10 % ( P < .02 ) , VO2 -61 109 mL/min ( P = .04 ) and VCO2 101 151 mL/min ( P < .02 ) .
RESULTS	Among 20 patients , PB disappeared in 1 and 7 subjects after acute and prolonged acetazolamide , respectively .
RESULTS	PB was present 80 % 26 , 65 % 28 , and 43 % 39 of exercise time before and after acute and prolonged acetazolamide , respectively .
RESULTS	Overnight apnea/hypopnea index decreased from 30.8 83.8 to 21.1 16.9 ( P = .003 ) .
CONCLUSIONS	In HF , inhaled CO2 and acetazolamide reduce exercise PB with additional benefits of acetazolamide on sleep PB .

###25435604
BACKGROUND	In the present study , `` Diabegon '' a poly-herbal preparation , with hypoglycemic activity , was evaluated for its preventive effect in metabolic syndrome subjects with type 2 diabetes and also to reveal its side effects , on liver and kidney .
METHODS	Type 2 diabetic subjects with metabolic syndrome ( N = 58 ) were categorized on the basis of age and fasting blood glucose .
METHODS	The grouping was as follows : Group I ( 35-50 yrs ) , Group II ( 51-65 yrs ) , Group III > 65 yrs , Group IV FBS < 145.9 , Group V FBS > 145 .
METHODS	Each group was administered 4 gm of diabegon daily .
METHODS	Blood glucose levels , lipid profile , liver and kidney function of the subjects were regularly monitored within 3 months of interval to 18 months .
RESULTS	The reduction in fasting blood glucose level ranged from 12.3 % ( P < 0.05 ) to 42 % ( P < 0.001 ) after 18 month of therapy whereas in postprandial blood glucose , the decrease ranged from 28 % ( P < 0.05 ) to 32 % ( P < 0.05 ) after 18 month of therapy .
RESULTS	Overall reductions in the individual parameters of the metabolic syndrome subjects were significantly higher in Group I. Cholesterol level decreased from 11 % to 27.2 % ( P < 0.001 ) , triglyceride levels decreased from 24 % to 55 % , VLDL and LDL levels reduced by 60 % & 54 % respectively after 18 months of therapy .
RESULTS	The HDL-C level increased in all groups .
RESULTS	Moreover , diabegon administration for 1.5 years exhibited no alteration in liver and kidney function tests , which indicate its non-toxicity .
CONCLUSIONS	Our study suggests that diabegon could be included as a preventive treatment in metabolic syndrome subjects with type 2 diabetes especially for long term treatment as it efficiently shows anti-hyperglycemic and anti-lipidemic effects with no adverse impacts on the liver and kidney .

###24837543
BACKGROUND	Diet may substantially alter prostate cancer initiation and progression .
BACKGROUND	However , large-scale clinical trials of diet modification have yet to be performed for prostate cancer .
BACKGROUND	The Men 's Eating and Living ( MEAL ) Study ( CALGB 70807 [ Alliance ] ) is investigating the effect of increased vegetable consumption on clinical progression in men with localized prostate cancer .
METHODS	MEAL is a randomized , phase III clinical trial designed to test whether an intervention that increases vegetable intake will decrease the incidence of clinical progression in men with clinically localized prostate cancer on active surveillance .
METHODS	We are randomizing 464 patients to either a validated telephone-based diet counseling intervention or a control condition in which patients receive a published diet guideline .
METHODS	The intervention will continue for two years .
METHODS	The primary outcome variable is clinical progression defined by serum prostate-specific antigen ( PSA ) and pathological findings on follow-up prostate biopsy .
METHODS	Secondary outcome variables include incidence of surgical and non-surgical treatments for prostate cancer , prostate-cancer related patient anxiety and health-related quality of life .
CONCLUSIONS	The MEAL Study is assessing the effectiveness of a high-vegetable diet intervention for preventing clinical progression in men with localized prostate cancer on active surveillance .

###24564568
BACKGROUND	Current clinical assessments of motor function in Huntington 's Disease ( HD ) rely on subjective ratings such as the Unified Huntington 's Disease Rating scale ( UHDRS ) .
BACKGROUND	The ability to track disease progression using simple , objective , inexpensive , and robust measures would be beneficial .
METHODS	One objective measure of motor performance is hand-tapping .
METHODS	Over the last 14 years we have routinely collected , using a simple device , the number of taps made by the right and left hand over 30 seconds in HD patients attending our NHS clinics .
RESULTS	Here we report on a longitudinal cohort of 237 patients , which includes patients at all stages of the disease on a wide range of drug therapies .
RESULTS	Hand tapping in these patients declines linearly at a rate of 5.1 taps per year ( p < 0.0001 ; 95 % CI = 3.8 to 6.3 taps ) , and for each additional year of age patients could perform 0.9 fewer taps ( main effect of age : p = 0.0007 ; 95 % CI = 0.4 to 1.4 ) .
RESULTS	Individual trajectories can vary widely around this average rate of decline , and much of this variation could be attributed to CAG repeat length .
RESULTS	Genotype information was available for a subset of 151 patients , and for each additional repeat , patients could perform 5.6 fewer taps ( p < 0.0001 ; 95 % CI = 3.3 to 8.0 taps ) , and progressed at a faster rate of 0.45 fewer taps per year ( CAG by time interaction : p = 0.008 ; 95 % CI = 0.12 to 0.78 taps ) .
RESULTS	In addition , for each unit decrease in Total Functional Capacity ( TFC ) within individuals , the number of taps decreased by 6.3 ( 95 % CI = 5.4 to 7.1 , p < 0.0001 ) .
CONCLUSIONS	Hand tapping is a simple , robust , and reliable marker of disease progression .
CONCLUSIONS	As such , this simple motor task could be a useful tool by which to assess disease progression as well therapies designed to slow it down .

###24512643
BACKGROUND	Prostate cancer screening depends on a careful balance of benefits , in terms of reduced prostate cancer mortality , and harms , in terms of overdiagnosis and overtreatment .
BACKGROUND	We aimed to estimate the effect on overdiagnosis of restricting prostate specific antigen ( PSA ) testing by age and baseline PSA .
METHODS	Estimates of the effects of age on overdiagnosis were based on population based incidence data from the US Surveillance , Epidemiology and End Results database .
METHODS	To investigate the relationship between PSA and overdiagnosis , we used two separate cohorts subject to PSA testing in clinical trials ( n = 1,577 and n = 1,197 ) and a population-based cohort of Swedish men not subject to PSA-screening followed for 25 years ( n = 1,162 ) .
RESULTS	If PSA testing had been restricted to younger men , the number of excess cases associated with the introduction of PSA in the US would have been reduced by 85 % , 68 % and 42 % for age cut-offs of 60 , 65 and 70 , respectively .
RESULTS	The risk that a man with screen-detected cancer at age 60 would not subsequently lead to prostate cancer morbidity or mortality decreased exponentially as PSA approached conventional biopsy thresholds .
RESULTS	For PSAs below 1 ng/ml , the risk of a positive biopsy is 65 ( 95 % CI 18.2 , 72.9 ) times greater than subsequent prostate cancer mortality .
CONCLUSIONS	Prostate cancer overdiagnosis has a strong relationship to age and PSA level .
CONCLUSIONS	Restricting screening in men over 60 to those with PSA above median ( > 1 ng/ml ) and screening men over 70 only in selected circumstances would importantly reduce overdiagnosis and change the ratio of benefits to harms of PSA-screening .

###25350228
OBJECTIVE	The purpose of the study was to compare the outcome of laparoscopic sacral colpocervicopexy with laparoscopic pectopexy .
OBJECTIVE	Our aim was to show that the safety and effectiveness of the new technique is similar to the traditional technique .
OBJECTIVE	We expected differences regarding defecation disorders .
METHODS	We randomly assigned patients to two treatment groups : 44 in the pectopexy and 41 in the sacropexy group .
METHODS	If necessary , the operative procedures were planned in a so-called multicompartment setting regarding the different pelvic floor disorders .
METHODS	All defects were managed at the same time .
METHODS	Eighty-one patients were examined 12 to 37 months after treatment ( mean follow-up 20.67 months ) .
RESULTS	The long-term follow-up ( 21.8 months for pectopexy and 19.5 months for sacropexy ) showed a clear difference regarding de novo defecation disorders ( 0 % in the pectopexy vs 19.5 % in the sacropexy group ) .
RESULTS	The incidence of de novo stress urinary incontinence was 4.8 % ( pectopexy ) vs 4.9 % ( sacropexy ) .
RESULTS	The incidence of rectoceles ( 9.5 % vs 9.8 % ) was similar in both groups .
RESULTS	No de novo lateral defect cystoceles were found after pectopexy , whereas 12.5 % were found after sacropexy .
RESULTS	The apical descensus relapse rates , 2.3 % for pectopexy vs 9.8 % for sacropexy , were not statistically significant .
RESULTS	The occurrence of de novo anterior defect cystoceles and rectoceles revealed no significant differences .
CONCLUSIONS	Laparoscopic pectopexy is a novel method of vaginal prolapse therapy that offers clear practical advantages compared with laparoscopic sacropexy .
CONCLUSIONS	Because laparoscopic pectopexy does not reduce the pelvic space , it results in a zero percentage of defecation disorders .

###24791578
BACKGROUND	The effect of dietary macronutrient composition on the rate of gestational weight gain among women in sub-Saharan Africa is unclear .
OBJECTIVE	To examine the effect of macronutrient intake on the rate of gestational weight gain among HIV-negative women in Tanzania .
METHODS	The weights of 8,428 women were measured monthly from 12 weeks of gestation to term .
METHODS	Prenatal dietary intake was estimated as the cumulative average of multiple 24-hour dietary recalls .
METHODS	The association between energy intake and percentage of energy from carbohydrate , protein , and total fat and rate of weight gain ( grams per month ) was estimated from generalized estimating equation models .
METHODS	Macronutrient effects were adjusted for total energy using the nutrient density model and maternal age , maternal height , maternal mid-upper-arm circumference , parity , marital status , maternal occupation , maternal education , household wealth , season , and treatment regimen assignment .
METHODS	Body mass index ( BMI ) was considered as a confounder and a potential modifier of the effect of macronutrient intake on gestational weight gain .
RESULTS	A 6 g/month increase in rate of weight gain was associated with every 100-kcal increment in daily total energy intake ( 95 % CI , 1 to 12 ; p = .03 ) .
RESULTS	Analyses substituting 5 % of energy from fat by protein showed that weight gain would decrease by 72 g/month ( 95 % CI , 6 to 140 ; p = .03 ) ; substituting 5 % of energy from carbohydrate by protein decreased gain by 70 g/month ( 95 % CI , 15 to 124 ; p = .01 ) .
RESULTS	Baseline BMI did not modify these associations .
CONCLUSIONS	Further research on the effects of macronutrient composition on gestational weight gain is needed to inform the design of supplementation programs for women in developing countries .

###25330169
BACKGROUND	Implementation of self-management support in traditional primary care settings has proved difficult , encouraging the development of alternative models which actively link to community resources .
BACKGROUND	Chronic kidney disease ( CKD ) is a common condition usually diagnosed in the presence of other co-morbidities .
BACKGROUND	This trial aimed to determine the effectiveness of an intervention to provide information and telephone-guided access to community support versus usual care for patients with stage 3 CKD .
RESULTS	In a pragmatic , two-arm , patient level randomised controlled trial 436 patients with a diagnosis of stage 3 CKD were recruited from 24 general practices in Greater Manchester .
RESULTS	Patients were randomised to intervention ( 215 ) or usual care ( 221 ) .
RESULTS	Primary outcome measures were health related quality of life ( EQ-5D health questionnaire ) , blood pressure control , and positive and active engagement in life ( heiQ ) at 6 months .
RESULTS	At 6 months , mean health related quality of life was significantly higher for the intervention group ( adjusted mean difference = 0.05 ; 95 % CI = 0.01 , 0.08 ) and blood pressure was controlled for a significantly greater proportion of patients in the intervention group ( adjusted odds-ratio = 1.85 ; 95 % CI = 1.25 , 2.72 ) .
RESULTS	Patients did not differ significantly in positive and active engagement in life .
RESULTS	The intervention group reported a reduction in costs compared with control .
CONCLUSIONS	An intervention to provide tailored information and telephone-guided access to community resources was associated with modest but significant improvements in health related quality of life and better maintenance of blood pressure control for patients with stage 3 CKD compared with usual care .
CONCLUSIONS	However , further research is required to identify the mechanisms of action of the intervention .
BACKGROUND	Controlled-Trials .
BACKGROUND	com ISRCTN45433299 .

###24521888
OBJECTIVE	To evaluate the efficacy and tolerability of a furazolidone-based quadruple rescue regimen in patients with previously failed Helicobacter pylori ( H.pylori ) eradication treatment .
METHODS	A total of 156 patients were recruited from July 2011 to June 2013 at Beijing Hospital and randomized into one of the following 10-day treatment regimens : ( 1 ) Esomeprazole 20 mg twice daily , furazolidone 100 mg twice daily , amoxicillin 1000 mg twice daily , bismuth salts 150 mg thrice daily for 10 days .
METHODS	( 2 ) Esomeprazole 20 mg twice daily , levofloxacin 500 mg daily , amoxicillin 1000 mg twice daily , bismuth salts 150 mg thrice daily for 10 days .
METHODS	H.pylori status was re-assessed with the ( 13 ) C-urea breath test at 4 weeks after the end of therapy .
RESULTS	The intention-to-treat ( ITT ) and per-protocol ( PP ) H.pylori eradication rates were 83.8 % ( 67/80 ) and 88.2 % ( 67/76 ) in the furazolidone-based quadruple group , and 69.7 % ( 53/76 ) and 73.6 % ( 53/72 ) in the levofloxacin-based quadruple group respectively ( ( 2 ) = 4.311 , 5.100 ; P = 0.038 , 0.024 ) .
CONCLUSIONS	The 10-day furazolidone-based quadruple therapy is an efficacious rescue strategy in patients with previously failed eradication therapy .

###25839715
BACKGROUND	TETRA ( terrestrial trunked radio ) is a digital radio communication standard , which has been implemented in several European countries and is used by public executives , transportation services , and by private companies .
BACKGROUND	Studies on possible impacts on the users ' health considering different exposure conditions are missing .
OBJECTIVE	To investigate possible acute effects of electromagnetic fields ( EMF ) of two different levels of TETRA hand-held transmitter signals on cognitive function and well-being in healthy young males .
METHODS	In the present double-blind cross-over study possible effects of short-term ( 2.5 h ) EMF exposure of handset-like signals of TETRA ( 385 MHz ) were studied in 30 healthy male participants ( meanSD : 25.42.6 years ) .
METHODS	Individuals were tested on nine study days , on which they were exposed to three different exposure conditions ( Sham , TETRA 1.5 W/kg and TETRA 6.0 W/kg ) in a randomly assigned and balanced order .
METHODS	Participants were tested in the afternoon at a fixed timeframe .
RESULTS	Attention remained unchanged in two out of three tasks .
RESULTS	In the working memory significant changes were observed in two out of four subtasks .
RESULTS	Significant results were found in 5 out of 35 tested parameters , four of them led to an improvement in performance .
RESULTS	Mood , well-being and subjective somatic complaints were not affected by TETRA exposure .
CONCLUSIONS	The results of the present study do not indicate a negative impact of a short-term EMF-effect of TETRA on cognitive function and well-being in healthy young men .

###24284150
BACKGROUND	Theory suggests the uptake of a medical innovation is influenced by how potential adopters perceive innovation characteristics and by characteristics of potential adopters .
BACKGROUND	Innovation adoption is slow among the first 20 % of individuals in a target group and then accelerates .
BACKGROUND	The Quality Initiative in Rectal Cancer ( QIRC ) trial assessed if rectal cancer surgery outcomes could be improved through surgeon participation in the QIRC strategy .
BACKGROUND	We tested if traditional uptake of innovation concepts applied to surgeons in the experimental arm of the trial .
METHODS	The QIRC strategy included workshops , access to opinion leaders , intraoperative demonstrations , postoperative questionnaires , and audit and feedback .
METHODS	For intraoperative demonstrations , a participating surgeon invited an outside surgeon to demonstrate optimal rectal surgery techniques .
METHODS	We used surgeon timing in a demonstration to differentiate early and late adopters of the QIRC strategy .
METHODS	Surgeons completed surveys on perceptions of the strategy and personal characteristics .
RESULTS	Nineteen of 56 surgeons ( 34 % ) requested an operative demonstration on their first case of rectal surgery .
RESULTS	Early and late adopters had similar perceptions of the QIRC strategy and similar characteristics .
RESULTS	Late adopters were less likely than early adopters to perceive an advantage for the surgical techniques promoted by the trial ( p = 0.023 ) .
CONCLUSIONS	Most traditional diffusion of innovation concepts did not apply to surgeons in the QIRC trial , with the exception of the importance of perceptions of comparative advantage .

###25681466
BACKGROUND	Target temperature management is recommended as a neuroprotective strategy after out-of-hospital cardiac arrest .
BACKGROUND	Potential effects of different target temperatures on cognitive impairment commonly described in survivors have not been investigated sufficiently .
BACKGROUND	The primary aim of this study was to evaluate whether a target temperature of 33C compared with 36C was favorable for cognitive function ; the secondary aim was to describe cognitive impairment in cardiac arrest survivors in general .
RESULTS	Study sites included 652 cardiac arrest survivors originally randomized and stratified for site to temperature control at 33C or 36C within the Target Temperature Management trial .
RESULTS	Survival until 180 days after the arrest was 52 % ( 33C , n = 178/328 ; 36C , n = 164/324 ) .
RESULTS	Survivors were invited to a face-to-face follow-up , and 287 cardiac arrest survivors ( 33C , n = 148/36C , n = 139 ) were assessed with tests for memory ( Rivermead Behavioural Memory Test ) , executive functions ( Frontal Assessment Battery ) , and attention/mental speed ( Symbol Digit Modalities Test ) .
RESULTS	A control group of 119 matched patients hospitalized for acute ST-segment-elevation myocardial infarction without cardiac arrest performed the same assessments .
RESULTS	Half of the cardiac arrest survivors had cognitive impairment , which was mostly mild .
RESULTS	Cognitive outcome did not differ ( P > 0.30 ) between the 2 temperature groups ( 33C/36C ) .
RESULTS	Compared with control subjects with ST-segment-elevation myocardial infarction , attention/mental speed was more affected among cardiac arrest patients , but results for memory and executive functioning were similar .
CONCLUSIONS	Cognitive function was comparable in survivors of out-of-hospital cardiac arrest when a temperature of 33C and 36C was targeted .
CONCLUSIONS	Cognitive impairment detected in cardiac arrest survivors was also common in matched control subjects with ST-segment-elevation myocardial infarction not having had a cardiac arrest .
BACKGROUND	URL : http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01946932 .

###24770498
BACKGROUND	Genital warts are caused by human papillomavirus infection and represent one of the most common sexually transmitted diseases .
BACKGROUND	Many infections are transient but the virus may recur , persist , or become latent .
BACKGROUND	To date , there is no effective antiviral treatment to eliminate HPV infection and most therapies are aimed at the destruction of visible lesions .
BACKGROUND	Potassium hydroxide is a strong alkali that has been shown to be safe and effective for the treatment of genital warts and molluscum contagiosum .
BACKGROUND	Cryotherapy is considered one of the most established treatments for genital warts .
BACKGROUND	No comparative trials have been reported to date on the use of potassium hydroxide for genital warts .
OBJECTIVE	A prospective , open-label , randomized clinical trial was conducted to compare topical potassium hydroxide versus cryotherapy in the treatment of genital warts affecting immunocompetent , sexually active men .
METHODS	Over a period of 10 months , 48 patients were enrolled .
METHODS	They were randomly divided into two groups and selected on an alternative basis for either potassium hydroxide therapy or cryotherapy .
METHODS	While response to therapy did not differ substantially between both treatment modalities , side effects such as local pain and post-treatment hypopigmentation were considerably more prevalent in the groups treated using cryotherapy .
RESULTS	In our study , potassium hydroxide therapy proved to be at least as effective as cryotherapy and offered the benefit of a better safety profile .
CONCLUSIONS	Topical 5 % potassium hydroxide presents an effective , safe , and low-cost treatment modality for genital warts in men and should be included in the spectrum of therapies for genital warts .

###25274783
BACKGROUND	Hallux valgus with an increased intermetatarsal angle is usually treated with a proximal metatarsal osteotomy .
BACKGROUND	The proximal chevron osteotomy is commonly used but is technically difficult .
BACKGROUND	This study compares the proximal opening wedge osteotomy of the first metatarsal with the proximal chevron osteotomy for the treatment of hallux valgus with an increased intermetatarsal angle .
METHODS	This prospective , randomized multicenter ( three-center ) study was based on the clinical outcome scores of the Short Form-36 , the American Orthopaedic Foot & Ankle Society forefoot questionnaire , and the visual analog scale for pain , activity , and patient satisfaction .
METHODS	Subjects were assessed prior to surgery and at three , six , and twelve months postoperatively .
METHODS	Surgeon preference was evaluated based on questionnaires and the operative times required for each procedure .
RESULTS	No significant differences were found for any of the patients ' clinical outcome measurements between the two procedures .
RESULTS	The proximal opening wedge osteotomy was found to lengthen , and the proximal chevron osteotomy was found to shorten , the first metatarsal .
RESULTS	The intermetatarsal angles improved ( decreased ) significantly , from 14.8 3.2 to 9.1 2.9 ( mean and standard deviation ) after a proximal opening wedge osteotomy and from 14.6 3.9 to 11.3 4.0 after a proximal chevron osteotomy ( p < 0.05 for both ) .
RESULTS	Operative time required for performing a proximal opening wedge osteotomy is similar to that required for performing a proximal chevron osteotomy ( mean and standard deviation , 67.1 16.5 minutes compared with 69.9 18.6 minutes ; p = 0.510 ) .
CONCLUSIONS	Opening wedge and proximal chevron osteotomies have comparable radiographic outcomes and comparable clinical outcomes for pain , satisfaction , and function .
CONCLUSIONS	The proximal opening wedge osteotomy lengthens , and the proximal chevron osteotomy shortens , the first metatarsal .
CONCLUSIONS	The proximal opening wedge osteotomy was subjectively less technically demanding and was preferred by the orthopaedic surgeons in this study .
METHODS	Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence .

###24280596
OBJECTIVE	The recent SHARP trial clearly demonstrated that a reduction in low-density lipoprotein ( LDL ) cholesterol with a daily regimen of simvastatin plus ezetimibe safely reduced the incidence of major atherosclerotic events in patients with chronic kidney disease ( CKD ) .
OBJECTIVE	We aimed to compare the efficacy of and adverse effects from statin uptitration versus statin in combination with ezetimibe since only a few studies have addressed this question .
METHODS	This was a randomized , open-label , multicenter trial that included 286 patients with CKD whose LDL cholesterol levels were not reduced below 120 mg/dl despite a minimum dose of statin therapy .
METHODS	Patients received double doses of statin or usual statin dose with the addition of ezetimibe 10 mg daily .
METHODS	The observation period was 1 year during which time patients were checked regularly in clinic for adverse effects as well as for usual laboratory examinations .
METHODS	The key prespecified outcome was the incidence of adverse effects , which included skeletal muscle complaints , myalgia , muscle weakness , and muscle cramps with and without elevated CK levels .
METHODS	Increases in alanine transaminase ( ALT ) or aspartate transaminase ( AST ) levels > 2 times the upper limit of normal ( ULN ) were considered clinically significant adverse effects .
RESULTS	Adverse events occurred in 9/145 in the combination group and in 24/141 in the statin uptitration group ( p < 0.01 ) .
RESULTS	Moreover , in patients with CKD of stages 3-5 , rates were 6/58 in the combination group versus 20/52 in the statin uptitration group ( p < 0.01 ) .
RESULTS	No serious adverse effects such as rhabdomyolysis were noted in either group .
RESULTS	Serum creatinine levels remained essentially unchanged in both groups except in CKD stages 4 and 5 .
RESULTS	Reductions in LDL cholesterol were similar between the two groups at the start of and at the end of the study .
RESULTS	During the study , no atherosclerotic events were reported in either group .
CONCLUSIONS	When statin uptitration produces adverse effects such as myopathy , combination therapy with ezetimibe is recommended instead of statin alone .

###24417600
OBJECTIVE	Family-based treatment models that have shown effectiveness with juvenile offenders may also lead to reduced criminality in siblings of those offenders .
OBJECTIVE	However , the lasting effects of such treatments on siblings have not been evaluated .
OBJECTIVE	In the present study , the authors examined criminal outcomes for siblings of serious and violent juvenile offenders who had participated on average 25.0 years earlier in a clinical trial of multisystemic therapy ( MST ; Borduin et al. , 1995 ) .
METHODS	Participants were 129 closest-in-age siblings of individuals who were originally randomized to MST or individual therapy ( IT ) during adolescence .
METHODS	Arrest and incarceration data were obtained in middle adulthood when siblings were on average 38.4 years old .
RESULTS	Intent-to-treat analyses showed that arrest rates were significantly lower for siblings in the MST condition than in the IT condition ( 43.3 % vs. 72.0 % , respectively ) .
RESULTS	In addition , siblings in the IT condition were about 3 times as likely to be convicted of a felony and more than twice as likely to be sentenced to incarceration and probation .
CONCLUSIONS	The present study represents the longest follow-up to date of sibling participants in an MST clinical trial and demonstrates that the positive impact of an evidence-based treatment for serious and violent juvenile offenders can extend to other family members .
CONCLUSIONS	Implications of the authors ' findings for policymakers and service providers are discussed .

###24300626
BACKGROUND	Community-acquired bacterial meningitis ( CABM ) is a life-threatening condition that is common among immunocompromised individuals .
BACKGROUND	Intravenous ceftriaxone , of which Rocephin ( ROC ) is the originator brand , is recommended as first-line therapy in South Africa .
BACKGROUND	Despite concerns regarding therapeutic equivalence with generic agents , this is the first study that has been conducted comparing clinical pharmacokinetics ( PK ) of a generic ceftriaxone formulation with the originator .
OBJECTIVE	To compare the PK and safety of Aspen Ceftriaxone ( AC ) and ROC in the treatment of adult CABM.Methods .
OBJECTIVE	A total of 63 eligible patients were randomised 1:1 to receive 2 g of either medication twice daily for a duration based on the identity of the causative organism and their physician 's clinical judgment .
OBJECTIVE	The primary endpoint of this study was the comparison of clinical PK , specifically the concentrations of each drug in the cerebrospinal fluid with corresponding paired plasma samples .
OBJECTIVE	While this study was underpowered to assess efficacy , safety could be evaluated on the basis of reported adverse events .
RESULTS	The two patient groups were epidemiologically similar .
RESULTS	There were no statistically significant differences in PK between either agent , nor any difference with regard to safety .
CONCLUSIONS	AC can be considered as equivalent to ROC with regard to PK and safety in patients with CABM .

###24619599
BACKGROUND	Although self-efficacy ( SE ) and outcome expectancy ( OE ) have been well researched as predictors of outcome , few studies have investigated changes in these variables across treatments .
BACKGROUND	We evaluated changes in OE and SE throughout treatment as predictors of outcomes in a large sample with panic disorder , generalized anxiety disorder , social anxiety disorder , or posttraumatic stress disorder .
BACKGROUND	We hypothesized that increases in SE and OE would predict reductions in anxiety and depression as well as improvement in functioning .
METHODS	Participants ( mean age = 43.3 years , SD = 13.2 , 71.1 % female , 55.5 % white ) were recruited from primary care centers throughout the United States and were randomized to receive either Coordinated Anxiety Learning and Management ( CALM ) treatment - composed of cognitive behavioral therapy , psychotropic medication , or both - or usual care .
METHODS	SE and OE ratings were collected at each session for participants in the CALM treatment ( n = 482 ) and were entered into a structural equation model as predictors of changes in Brief Symptom Inventory , Anxiety Sensitivity Index , Patient Health Questionnaire ( PHQ ) , and Sheehan Disability Scale outcomes at 6 , 12 , and 18 months after baseline .
RESULTS	The best-fitting models predict symptom levels from OE and SE and not vice versa .
RESULTS	The slopes and intercept of OE significantly predicted change in each outcome variable except PHQ-8 .
RESULTS	The slope and intercept of SE significantly predicted change in each outcome variable .
CONCLUSIONS	Over and above absolute level , increases in SE and OE were significant predictors of decreases in symptoms and increases in functioning .
CONCLUSIONS	Implications for treatment are discussed , as well as future directions of research .

###25065090
OBJECTIVE	To compare the efficacy of pelvic floor muscle exercise with the concentration therapy versus pelvic floor muscle exercise alone after radical prostatectomy .
METHODS	One hundred thirty five patients were randomized into the intervention group that concentration therapy was added to Kegel exercise , and control group that was Kegel exercise only , using the stratified randomization ( stratified by taking the catheter off before and after discharge ) and type of surgery .
METHODS	Incontinence was defined as a loss of urine equal or more than to 2 grams in one-hour pad test , before and after the test in each sample group .
METHODS	Follow-up results were obtained by phone visit at 3 , 4 , 5 , 6 , 8 , 10 , and 12 weeks after surgery
RESULTS	In the intervention group , 65 of 68 cases ( 95.6 % ) had continence in three months , compared to 48 of 67 ( 71.6 % ) in the control group , with significant statistical difference ( p-value < 0.001 ) .
RESULTS	The secondary result was the regularity in practicing .
RESULTS	It was 80 % in total .
RESULTS	In the intervention group , 66 of 68 cases ( 97.06 % ) practiced compared to 34 of 67 ( 50.75 % ) in the control group , which was significant difference between the two groups .
CONCLUSIONS	Combined concentration therapy with Kegel exercise had significantly improved continence after radical prostatectomy

###24703286
BACKGROUND	The purpose of this study was to determine the influence of self-tapping and self-drilling placement techniques on the stability of miniscrews .
METHODS	We included 70 orthodontic patients who received miniscrews ( 140 screws ) .
METHODS	Miniscrews measuring 1.6 mm in diameter and 8 mm in length were placed using the self-tapping ( 35 patients , 70 screws ) and self-drilling ( 35 patients , 70 screws ) methods .
METHODS	We examined the success rates , placement torque values , Periotest ( Medizintechnik Gulden , Bensheim , Germany ) values , rates of root contact , and influence of root contact on mobility .
METHODS	Cone-beam computed tomography was used to evaluate root contact .
METHODS	Miniscrews that endured an orthodontic force for 6 months or more were considered successful .
RESULTS	The success rates of the miniscrews were approximately 96 % with either placement technique .
RESULTS	The placement torques were 7 and 7.5 N cm in the self-tapping and self-drilling miniscrews , respectively ( P > 0.05 ) .
RESULTS	The Periotest values of the self-drilling method were significantly greater than those of the self-tapping method .
RESULTS	The Periotest values of the self-drilling miniscrews with root contact were significantly greater than those with no root contact .
CONCLUSIONS	Both placement techniques showed high stability in the maxillary bone , although the self-drilling miniscrews with root contact had greater mobility .
CONCLUSIONS	Special attention to root contact further improves the stability of the self-drilling miniscrews .

###24567366
BACKGROUND	Treatment options for wild-type BRAF melanoma patients remain limited .
BACKGROUND	Selumetinib , a MEK 1/2 inhibitor , suppresses pERK levels independent of BRAF and NRAS mutation status , and combination with docetaxel has demonstrated synergy in xenograft models .
BACKGROUND	The aim of this study was to assess the efficacy and safety of selumetinib plus docetaxel as first-line treatment in patients with wild-type BRAF advanced melanoma .
METHODS	In this double-blind multicentre phase II trial patients with wild-type BRAF melanoma were randomized ( 1:1 ) to docetaxel with selumetinib or placebo .
METHODS	Docetaxel 75 mg/m ( 2 ) was administered intravenously every 3 weeks up to six cycles .
METHODS	Selumetinib 75 mg or placebo was given orally twice daily until disease progression or unacceptable toxicity .
METHODS	The primary end point was progression-free survival ( PFS ) .
METHODS	Tumour NRAS mutation status was analysed retrospectively and correlated with treatment outcomes .
RESULTS	Eighty-three patients were randomized to docetaxel plus selumetinib ( n = 41 ) or docetaxel plus placebo ( n = 42 ) .
RESULTS	The PFS hazard ratio ( HR ) ( selumetinib : placebo ) was 0.75 [ 90 % confidence interval ( CI ) 0.50-1 .14 ; P = 0.130 ] , with a median PFS of 4.23 months ( 90 % CI 3.63-6 .90 ) for docetaxel plus selumetinib and 3.93 months ( 90 % CI 2.07-4 .16 ) for docetaxel alone .
RESULTS	There was no significant difference in overall survival .
RESULTS	The objective response rate was 32 % with selumetinib versus 14 % with placebo ( P = 0.059 ) .
RESULTS	In a retrospective subset analysis , NRAS mutation status did not affect significantly upon clinical outcomes in either arm .
RESULTS	The combination of docetaxel and selumetinib could be administered effectively to patients with metastatic melanoma , although the combination was less well tolerated than docetaxel alone .
CONCLUSIONS	The combination of docetaxel with selumetinib showed no significant improvement in PFS compared with docetaxel alone , although more patients showed a response to combination therapy .
CONCLUSIONS	We found no evidence to support using tumour NRAS mutation as a basis for selecting patients for combined MEK inhibitor and chemotherapy .
BACKGROUND	DOC-MEK ( EudraCT no : 2009-018153-23 ) .

###25733637
BACKGROUND	Cesarean delivery may reduce placental-fetal transfusion and thus increase the risk of early childhood anemia compared with vaginal delivery , but this notion has not been carefully studied in longitudinal cohorts .
OBJECTIVE	The aim was to assess the association of cesarean delivery with anemia in infants and children in 2 longitudinal Chinese birth cohorts from different socioeconomic settings .
METHODS	Cohort 1 was recruited from 5 counties in northeastern China and cohort 2 from 21 counties or cities in southeastern China .
METHODS	Cohort 1 involved 17,423 infants born during 2006-2009 to mothers with early pregnancy baseline hemoglobin concentrations ranging from 100 to 177 g/L , whereas cohort 2 involved 122,777 children born during 1993-1996 to mothers with baseline hemoglobin concentrations ranging from 60 to 190 g/L .
METHODS	The main outcomes were anemia at 6 and 12 mo in cohort 1 and at 58 mo in cohort 2 .
METHODS	Multiple logistic regressions were used to estimate adjusted ORs of anemia for cesarean compared with vaginal delivery .
METHODS	Stratified analyses were performed by pre - and postlabor cesarean delivery and according to maternal baseline hemoglobin concentration ( 109 , 110-119 , 120-129 , and 130 g/L ) .
RESULTS	Cesarean delivery was not associated with anemia at 6 mo in cohort 1 ( adjusted OR : 1.05 ; 95 % CI : 0.93 , 1.19 ) ; however , cesarean delivery was associated with increased anemia at 12 mo in cohort 1 ( adjusted OR : 1.19 ; 95 % CI : 1.04 , 1.37 ) and at 58 mo in cohort 2 ( adjusted OR : 1.11 ; 95 % CI : 1.08 , 1.15 ) .
RESULTS	The positive associations for anemia at 12 and 58 mo were consistent across maternal hemoglobin subgroups and persisted for cesarean delivery subtypes .
CONCLUSIONS	Cesarean delivery is likely associated with anemia in children , which suggests a possible need for exploring changes in obstetric care that might prevent anemia in cesarean-delivered children .

###26027431
BACKGROUND	Nivolumab ( a programmed death 1 [ PD-1 ] checkpoint inhibitor ) and ipilimumab ( a cytotoxic T-lymphocyte-associated antigen 4 [ CTLA-4 ] checkpoint inhibitor ) have been shown to have complementary activity in metastatic melanoma .
BACKGROUND	In this randomized , double-blind , phase 3 study , nivolumab alone or nivolumab plus ipilimumab was compared with ipilimumab alone in patients with metastatic melanoma .
METHODS	We assigned , in a 1:1:1 ratio , 945 previously untreated patients with unresectable stage III or IV melanoma to nivolumab alone , nivolumab plus ipilimumab , or ipilimumab alone .
METHODS	Progression-free survival and overall survival were coprimary end points .
METHODS	Results regarding progression-free survival are presented here .
RESULTS	The median progression-free survival was 11.5 months ( 95 % confidence interval [ CI ] , 8.9 to 16.7 ) with nivolumab plus ipilimumab , as compared with 2.9 months ( 95 % CI , 2.8 to 3.4 ) with ipilimumab ( hazard ratio for death or disease progression , 0.42 ; 99.5 % CI , 0.31 to 0.57 ; P < 0.001 ) , and 6.9 months ( 95 % CI , 4.3 to 9.5 ) with nivolumab ( hazard ratio for the comparison with ipilimumab , 0.57 ; 99.5 % CI , 0.43 to 0.76 ; P < 0.001 ) .
RESULTS	In patients with tumors positive for the PD-1 ligand ( PD-L1 ) , the median progression-free survival was 14.0 months in the nivolumab-plus-ipilimumab group and in the nivolumab group , but in patients with PD-L1-negative tumors , progression-free survival was longer with the combination therapy than with nivolumab alone ( 11.2 months [ 95 % CI , 8.0 to not reached ] vs. 5.3 months [ 95 % CI , 2.8 to 7.1 ] ) .
RESULTS	Treatment-related adverse events of grade 3 or 4 occurred in 16.3 % of the patients in the nivolumab group , 55.0 % of those in the nivolumab-plus-ipilimumab group , and 27.3 % of those in the ipilimumab group .
CONCLUSIONS	Among previously untreated patients with metastatic melanoma , nivolumab alone or combined with ipilimumab resulted in significantly longer progression-free survival than ipilimumab alone .
CONCLUSIONS	In patients with PD-L1-negative tumors , the combination of PD-1 and CTLA-4 blockade was more effective than either agent alone .
CONCLUSIONS	( Funded by Bristol-Myers Squibb ; CheckMate 067 ClinicalTrials.gov number , NCT01844505 . )

###25787196
BACKGROUND	Transcatheter aortic valve replacement ( TAVR ) is an option in certain high-risk surgical patients with severe aortic valve stenosis .
BACKGROUND	It is unknown whether TAVR can be safely introduced to lower-risk patients .
OBJECTIVE	The NOTION ( Nordic Aortic Valve Intervention Trial ) randomized clinical trial compared TAVR with surgical aortic valve replacement ( SAVR ) in an all-comers patient cohort .
METHODS	Patients 70 years old with severe aortic valve stenosis and no significant coronary artery disease were randomized 1:1 to TAVR using a self-expanding bioprosthesis versus SAVR .
METHODS	The primary outcome was the composite rate of death from any cause , stroke , or myocardial infarction ( MI ) at 1 year .
RESULTS	A total of 280 patients were randomized at 3 Nordic centers .
RESULTS	Mean age was 79.1 years , and 81.8 % were considered low-risk patients .
RESULTS	In the intention-to-treat population , no significant difference in the primary endpoint was found ( 13.1 % vs. 16.3 % ; p = 0.43 for superiority ) .
RESULTS	The result did not change in the as-treated population .
RESULTS	No difference in the rate of cardiovascular death or prosthesis reintervention was found .
RESULTS	Compared with SAVR-treated patients , TAVR-treated patients had more conduction abnormalities requiring pacemaker implantation , larger improvement in effective orifice area , more total aortic valve regurgitation , and higher New York Heart Association functional class at 1 year .
RESULTS	SAVR-treated patients had more major or life-threatening bleeding , cardiogenic shock , acute kidney injury ( stage II or III ) , and new-onset or worsening atrial fibrillation at 30 days than did TAVR-treated patients .
CONCLUSIONS	In the NOTION trial , no significant difference between TAVR and SAVR was found for the composite rate of death from any cause , stroke , or MI after 1 year .
CONCLUSIONS	( Nordic Aortic Valve Intervention Trial [ NOTION ] ; NCT01057173 ) .

###25501720
BACKGROUND	Current guidelines suggest a fasting time of 2 h for clear fluids , which is often exceeded in clinical practice , leading to discomfort , dehydration and stressful anaesthesia induction to patients , especially in the paediatric population .
BACKGROUND	Shorter fluid fasting might be a strategy to improve patient comfort but has not been investigated yet .
BACKGROUND	This prospective clinical trial compares gastric pH and residual volume after 1 vs 2 h of preoperative clear fluid fasting .
METHODS	Children ( 1-16 yr , ASA I or II ) undergoing elective procedures in general anaesthesia requiring tracheal intubation were randomized into group A with 60 min or B with 120 min preoperative clear fluid fasting .
METHODS	To determine gastric pH and residual volume , the gastric content was sampled in supine , left and right lateral patient position using an oro-gastric tube after intubation .
METHODS	Data are median ( interquartile range ) for group A or B ( P < 0.05 ) .
RESULTS	In total , 131 children aged 1.01-16 .23 yr were included ; gastric pH was determined in 120 cases .
RESULTS	Patient characteristic data were similar between the two groups , except for gender ( 46/33 males in group A/B ; P = 0.02 ) .
RESULTS	Despite significantly shorter fasting times for clear fluids in group A compared with group B ( 76/136 min ; P < 0.001 ) , no significant difference was observed regarding gastric pH [ 1.43 ( 1.30-1 .56 ) / 1.44 ( 1.29-1 .68 ) , P = 0.66 ] or residual volume [ 0.43 ( 0.21-0 .84 ) / 0.46 ( 0.19-0 .78 ) ml kg ( -1 ) , P = 0.47 ] .
CONCLUSIONS	One hour clear fluid fasting does not alter gastric pH or residual volume significantly compared with 2 h fasting .
BACKGROUND	The study was approved by the local ethics committee ( KEK-ZH-Nr .
BACKGROUND	2011-0034 ) and registered with ClinicalTrials.gov ( NCT01516775 ) .

###25138548
OBJECTIVE	The objective of this study was to explore the significance of assessing irreversible airway obstruction ( IAO ) in asthma patients by high-resolution computed tomography ( HRCT ) , biological markers in induced sputum , and exhaled nitric oxide ( FENO ) .
METHODS	The study was conducted in 34 patients with IAO , 46 patients with reversible airway obstruction ( RAO ) , 40 patients who did not have airway obstruction ( NAO ) , and 40 healthy subjects serving as controls .
METHODS	These patients received a step therapy for at least 3 months based on the guidelines for the prevention and treatment of asthma .
METHODS	After achieving complete or partial control of asthma , HRCT , lung function , FENO , and chemokine levels in induced sputum were measured .
RESULTS	The airway wall area ( WA ; % ) correlated with forced expiratory volume-1 ( FEV-1 ( L ) ; r = -0.67 , p < 0.0001 ) , and significant differences in bronchial wall thickening ( BWT ) of the LEVEL E generation airways were observed between the asthma and control groups ( p < 0.01 ) .
RESULTS	FENO levels correlated with FEV-1 ( % ) in the IAO group ( r = 0.49 , p = 0.01 ) .
RESULTS	The levels of matrix metalloproteases-9 ( MMP-9 ) and tissue inhibitor of matrix metalloproteinase-1 ( TIMP-1 ) in asthma patients with IAO , RAO , and NAO were significantly higher than those in the controls ( p < 0.05 ) .
RESULTS	The level of neutrophilia in the sputum from the IAO group was higher than that from the RAO , NAO and control groups .
CONCLUSIONS	Asthma patients with IAO have an increased BWT .
CONCLUSIONS	Airway measurements with HRCT scans appear to be valuable in the evaluation of airway remodeling in asthma patients with IAO .

###24843960
OBJECTIVE	To observe the difference in the therapeutic effects on knee osteoarthritis ( KOA ) among auricular electroacupuncture therapy plus isolated moxibustion with Lingxian herbal paste ( combined therapy ) , electroacupuncture ( EA ) and TDP irradiation .
METHODS	Eighty-nine cases were randomized into three groups .
METHODS	In the combined therapy group ( 30 cases ) , the auricular electroacupuncture therapy was adopted together with the isolated moxibustion with Lingxian herbal paste .
METHODS	The auricular points were xi ( AH4 ) , pizhixia ( AT4 ) , shenmen ( TF4 ) , etc. .
METHODS	The Lingxian herbal paste was applied at Yanglingquan ( GB 34 ) , Dubi ( ST 35 ) , Zusanli ( ST 36 ) , Neixiyan ( EX-LE 4 ) , Heding ( EX-LE 2 ) and Ashi points .
METHODS	In EA group ( 29 cases ) , EA was applied at the acupoints that were same as those in the isolated moxibustion with Lingxian herbal paste .
METHODS	In TDP group ( 30 cases ) , TDP irradiation was given at the affected knee .
METHODS	The treatment was given once every day , 10 treatments made one session and there was 1 week at the interval among sessions .
METHODS	Totally , 3 sessions of treatment were required .
METHODS	KOA clinical symptom and physical sign score and the single item pain symptom score of Lequesne index were observed before treatment and 1 week after treatment in the patients of each group separately .
METHODS	The efficacies were compared among the three groups .
RESULTS	One week after treatment , the total score of symptoms and physical signs of the patients in each group was reduced significantly as compared with that before treatment ( all P < 0.05 ) .
RESULTS	The improvements in the symptoms and physical signs in the combined therapy group were better than those in the other two groups ( 1.50 + / - 1.57 vs 2.52 + / - 1.82 , 2.63 + / - 1.97 , both P < 0.05 ) .
RESULTS	The improvement in pain in the combined therapy group was also better than that in the other two groups ( 2.37 + / - 0.81 vs 2.83 + / - 0.92 , P < 0.05 ; 2.37 + / - 0.81 vs 3.03 + / - 0.77 , P < 0.01 ) .
RESULTS	The curative rate in the combined therapy group was 40.0 % ( 12/30 ) , which was higher than 17.2 % ( 5/29 ) in EA group and 20.0 % ( 6/30 ) in TDP group separately ( both P < 0.01 ) .
RESULTS	The overall efficacy in the combined therapy group was superior to the other two groups ( P < 0.05 ) .
CONCLUSIONS	The auricular electroacupuncture therapy plus isolated moxibustion with Lingxian herbal paste is advantageous at the total score of the symptoms and physical signs and the overall efficacy in the patients of KOA as compared with EA at the local acupoints and local TDP irradiation .

###25695260
BACKGROUND	The successful recruitment and retention of participants is integral to the translation of research findings .
BACKGROUND	We examined the recruitment and retention rates of racial/ethnic minority adolescents at a center involved in the National Institutes of Health Obesity Research for Behavioral Intervention Trials ( ORBIT ) initiative by the 3 recruitment strategies used : clinic , informatics , and community .
METHODS	During the 9-month study , 186 family dyads , each composed of an obese African American adolescent and a caregiver , enrolled in a 6-month weight-loss intervention , a sequential multiple assignment randomized trial .
METHODS	We compared recruitment and retention rates by recruitment strategy and examined whether recruitment strategy was related to dyad baseline characteristics .
RESULTS	Of the 186 enrolled families , 110 ( 59.1 % ) were recruited through clinics , 53 ( 28.5 % ) through informatics , and 23 ( 12.4 % ) through community .
RESULTS	Of those recruited through community , 40.4 % enrolled in the study , compared with 32.7 % through clinics and 8.2 % through informatics .
RESULTS	Active refusal rate was 3 % .
RESULTS	Of the 1,036 families identified for the study , 402 passively refused to participate : 290 ( 45.1 % ) identified through informatics , 17 ( 29.8 % ) through community , and 95 ( 28.3 % ) through clinics .
RESULTS	Recruitment strategy was not related to the age of the adolescent , adolescent comorbidities , body mass index of the adolescent or caregiver , income or education of the caregiver , or retention rates at 3 months , 7 months , or 9 months .
RESULTS	Study retention rate was 87.8 % .
CONCLUSIONS	Using multiple recruitment strategies is beneficial when working with racial/ethnic minority adolescents , and each strategy can yield good retention .
CONCLUSIONS	Research affiliated with health care systems would benefit from the continued specification , refinement , and dissemination of these strategies .

###25385729
OBJECTIVE	To determine whether any tumor biomarkers could account for the survival advantage observed in the LNH 03-2B trial among patients with diffuse large B-cell lymphoma ( DLBCL ) and low-intermediate risk according to the International Prognostic Index when treated with dose-intensive rituximab , doxorubicin , cyclophosphamide , vindesine , bleomycin , and prednisone ( R-ACVBP ) compared with standard rituximab , doxorubicin , cyclophosphamide , vincristine , and prednisone ( R-CHOP ) .
METHODS	Using immunohistochemistry , expression of CD10 , BCL6 , MUM1 , MYC , and BCL2 and coexpression of MYC/BCL2 were examined .
METHODS	The interaction effects between each biomarker and treatment arm on survival were studied in a restricted model and a full model incorporating clinical parameters .
RESULTS	Among the 379 patients analyzed in the trial , 229 tumors were evaluable for germinal center B-cell-like ( GCB ) / non-GCB subclassification according to the Hans algorithm .
RESULTS	Among all the biomarkers , only the interaction between the Hans algorithm and the treatment arm was significant for progression-free survival ( PFS ) and overall survival ( OS ) in univariable ( PFS , P = .04 ; OS , P = .01 ) and multivariable ( PFS , P = .03 ; OS , P = .01 ) analyses .
RESULTS	Non-GCB tumors predicted worse PFS ( hazard ratio [ HR ] , 3.21 ; 95 % CI , 1.29 to 8.00 ; P = .01 ) and OS ( HR , 6.09 ; 95 % CI , 1.37 to 27.03 ; P = .02 ) among patients treated with R-CHOP compared with patients who received R-ACVBP , whereas there were no significant survival differences between these regimens among patients with GCB tumors .
CONCLUSIONS	The survival benefit related to R-ACVBP over R-CHOP is at least partly linked to improved survival among patients with non-GCB DLBCL .
CONCLUSIONS	Therefore , the Hans algorithm could be considered a theragnostic biomarker for selecting young patients with DLBCL who can benefit from an intensified R-ACVBP immunochemotherapy regimen .

###25110226
BACKGROUND	Glucose , the conventional osmotic agent in peritoneal dialysis ( PD ) solutions , may contribute to atherogenic dyslipoproteinemia and increased cardiovascular risk .
OBJECTIVE	To determine whether a low-glucose PD regimen may improve the serum lipid and lipoprotein profile in patients with diabetes .
METHODS	A prospective , open-label , parallel group , multinational , randomized , controlled trial with a 6-month follow-up , comprising 251 patients with diabetes receiving PD .
METHODS	Patients were randomized to a low-glucose PD regimen ( dextrose-based PD solution plus icodextrin , a starch polymer , and amino acids ) or a conventional PD regimen ( dextrose PD solutions ) .
METHODS	Serum lipid and apolipoprotein profiles were determined at baseline and 3 and 6 months .
RESULTS	Serum triglycerides , very low-density-lipoprotein cholesterol , and apolipoprotein B ( apoB ) decreased significantly in the intervention group at both 3 and 6 months compared with baseline ( serum triglycerides : median change at 3 months -0.5 mmol/L , P < .001 , at 6 months -0.3 mmol/L , P < .001 ; very low-density-lipoprotein cholesterol : -0.3 mg/dL , P < .001 ; -0.3 mg/dL , P < .001 ; and apoB : -8.5 mg/dL , P < .001 ; -3.6 mg/dL , P = .043 , respectively ) and also compared with the control group .
RESULTS	In contrast , apoB levels increased significantly in the control group at 3 and 6 months compared with baseline ( 5.3 mg/dL , P = .041 ; 5.2 mg/dL , P = .007 , respectively ) .
RESULTS	Percentage of patients on lipid-lowering medications at baseline and intensity of therapy was equivalent in each group .
RESULTS	The apoB decrease was not affected by lipid-lowering medications in the intervention group .
CONCLUSIONS	A low glucose-PD regimen significantly improved the atherogenic lipoprotein phenotype compared with PD patients treated with a conventional glucose regimen .

###26093599
OBJECTIVE	Epidemiological studies have shown that low levels of dehydroepiandrosterone might increase the risk of developing metabolic syndrome .
OBJECTIVE	The aim of this study was to evaluate whether dehydroepiandrosterone supplementation in schizophrenic patients treated with olanzapine would influence the anthropometric and biochemical parameters of metabolic syndrome .
METHODS	Male schizophrenic patients ( no = 55 ) participated in a twelve-week , randomized , double blind , placebo controlled study .
METHODS	They received 100 mg dehydroepiandrosterone ( DHEA ) or placebo as an augmentation of olanzapine treatment ( an average dosage 15 mg/day ) .
METHODS	Main outcomes of the study were changes in lipid profile , fasting glucose levels , body mass index and waist circumference values .
RESULTS	Forty five patients completed the study .
RESULTS	There were no major changes in the overall cholesterol value , HDL cholesterol , LDL cholesterol or triglycerides in either group .
RESULTS	The results of the repeated measures analysis of the system : fasting glucose level 2x , ( at the beginning and end of the study ) , 2x ( the study group and the control group ) , showed a significant interaction ( F = 5.7 , df = 1.000 p = 0.021 ) .
RESULTS	The blood glucose level was decreased in the DHEA group .
RESULTS	Furthermore , increases in waist circumference ( delta = -1.11 , t = -2.87 ; df = 20 ; p = 0.01 ) and BMI value ( delta = -0.48 , t = -2.38 ; df = 19 ; p = 0.028 ) were observed in the placebo group .
CONCLUSIONS	Dehydroepiandrosterone supplementation results in stabilization of BMI , waist circumference and fasting glycaemia values in schizophrenic patients treated with olanzapine .
CONCLUSIONS	To confirm the insulin-like effect of dehydroepiandrosterone , long-term research concentrating on the evaluation of glucose metabolism has to be performed .

###25546476
OBJECTIVE	To assess the relief of migraine pain , especially in the acute phase , by comparing active treatment , ie , kinetic oscillation stimulation ( KOS ) in the nasal cavity , with placebo .
BACKGROUND	Exploratory trials testing the efficacy of KOS on migraine patients indicated that this treatment could be a fast-acting remedy for acute migraine pain .
METHODS	Thirty-six patients were randomized 1:1 using a placebo module to active or placebo treatment in this double-blinded parallel design study .
METHODS	Treatment was administered with a minimally invasive inflatable tip oscillating catheter .
METHODS	Symptom scores ( 0-10 visual analog scale ) were obtained before treatment , every 5 minutes during treatment , at 15 minutes , 2 , and 24 hours post-treatment , as well as daily ( 0-3 migraine pain scale ) from 30 days pretreatment until Day 60 post .
METHODS	Thirty-five patients were evaluated ( active n = 18 , placebo n = 17 ) .
METHODS	The primary end-point was the change in average pain score from before treatment to 15 minutes after treatment .
RESULTS	Patients who received active treatment reported reduced pain , eg , average visual analog scale pain scores fell from 5.5 before treatment to 1.2 15 minutes after , while the corresponding scores for recipients of placebo fell from 4.9 to 3.9 .
RESULTS	The changes in pain scores differed between the 2 treatments by 3.3 points ( 95 % confidence interval : 2.3 , 4.4 ) , P < .001 .
RESULTS	Already 5 minutes into the treatment , the difference ( 1.9 points ) was significant ( P = .007 ) .
RESULTS	The difference was likewise significant at 2 hours post-treatment ( 3.7 points , P < .001 ) .
RESULTS	One patient experienced an adverse event ( a vasovagal reaction with full spontaneous recovery ) during placebo treatment .
CONCLUSIONS	KOS is an effective and safe treatment for acute migraine pain .

###25068546
BACKGROUND	Melasma is a common disorder of facial hyperpigmentation that is often resistant to treatment .
OBJECTIVE	To evaluate the efficacy of trichloroacetic acid ( TCA ) peeling in comparison with double frequency Q-switched neodymium-doped : yttrium aluminum garnet ( QS-Nd : YAG ) laser in the treatment of melasma .
METHODS	Sixty-five adult Egyptian female patients with melasma were enrolled in this study .
METHODS	Wood light was used for determination of the histological type of melasma .
METHODS	The patients were divided into 4 groups according to treatment modalities : peeling with different concentrations of TCA and double frequency QS-Nd : YAG laser .
METHODS	Trichloroacetic acid peeling was performed every 2 weeks up to 8 sessions , whereas laser treatment was performed every month up to 6 sessions .
METHODS	Melasma area and severity index ( MASI ) score was used before and after treatment for evaluation .
RESULTS	Improvement percentage of MASI score was significantly higher among patients treated with TCA 25 % ( p < .001 ) .
RESULTS	Epidermal type of melasma was significantly improved compared with the dermal type ( p = .0029 ) .
RESULTS	Q-switched neodymium-doped : yttrium aluminum garnet laser showed the highest incidence of postinflammatory hyperpigmentation ( 53.3 % ) .
CONCLUSIONS	Trichloroacetic acid peeling is effective in the treatment of melasma , TCA 25 % was the most effective concentration .
CONCLUSIONS	Q-switched neodymium-doped : yttrium aluminum garnet laser is not recommended in the treatment of melasma because it was associated with the highest incidence of complications .

###25130995
BACKGROUND	We investigated whether 18 months of androgen suppression plus radiotherapy , with or without 18 months of zoledronic acid , is more effective than 6 months of neoadjuvant androgen suppression plus radiotherapy with or without zoledronic acid .
METHODS	We did an open-label , randomised , 22 factorial trial in men with locally advanced prostate cancer ( either T2a N0 M0 prostatic adenocarcinomas with prostate-specific antigen [ PSA ] 10 g/L and a Gleason score of 7 , or T2b-4 N0 M0 tumours regardless of PSA and Gleason score ) .
METHODS	We randomly allocated patients by computer-generated minimisation -- stratified by centre , baseline PSA , tumour stage , Gleason score , and use of a brachytherapy boost -- to one of four groups in a 1:1:1:1 ratio .
METHODS	Patients in the control group were treated with neoadjuvant androgen suppression with leuprorelin ( 225 mg every 3 months , intramuscularly ) for 6 months ( short-term ) and radiotherapy alone ( designated STAS ) ; this procedure was either followed by another 12 months of androgen suppression with leuprorelin ( intermediate-term ; ITAS ) or accompanied by 18 months of zoledronic acid ( 4 mg every 3 months for 18 months , intravenously ; STAS plus zoledronic acid ) or by both ( ITAS plus zoledronic acid ) .
METHODS	The primary endpoint was prostate cancer-specific mortality .
METHODS	This analysis represents the first , preplanned assessment of oncological endpoints , 5 years after treatment .
METHODS	Analysis was by intention-to-treat .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00193856 .
RESULTS	Between Oct 20 , 2003 , and Aug 15 , 2007 , 1071 men were randomly assigned to STAS ( n = 268 ) , STAS plus zoledronic acid ( n = 268 ) , ITAS ( n = 268 ) , and ITAS plus zoledronic acid ( n = 267 ) .
RESULTS	Median follow-up was 74 years ( IQR 65-84 ) .
RESULTS	Cumulative incidences of prostate cancer-specific mortality were 41 % ( 95 % CI 22-70 ) in the STAS group , 78 % ( 49-115 ) in the STAS plus zoledronic acid group , 74 % ( 46-110 ) in the ITAS group , and 43 % ( 23-73 ) in the ITAS plus zoledronic acid group .
RESULTS	Cumulative incidence of all-cause mortality was 170 % ( 130-221 ) , 189 % ( 146-242 ) , 194 % ( 150-247 ) , and 139 % ( 103-188 ) , respectively .
RESULTS	Neither prostate cancer-specific mortality nor all-cause mortality differed between control and experimental groups .
RESULTS	Cumulative incidence of PSA progression was 342 % ( 286-399 ) in the STAS group , 396 % ( 336-455 ) in the STAS plus zoledronic acid group , 292 % ( 238-348 ) in the ITAS group , and 260 % ( 208-314 ) in the ITAS plus zoledronic acid group .
RESULTS	Compared with STAS , no difference was noted in PSA progression with ITAS or STAS plus zoledronic acid ; however , ITAS plus zoledronic acid reduced PSA progression ( sub-hazard ratio [ SHR ] 071 , 95 % CI 053-095 ; p = 0021 ) .
RESULTS	Cumulative incidence of local progression was 41 % ( 22-70 ) in the STAS group , 61 % ( 37-95 ) in the STAS plus zoledronic acid group , 15 % ( 05-37 ) in the ITAS group , and 34 % ( 17-61 ) in the ITAS plus zoledronic acid group ; no differences were noted between groups .
RESULTS	Cumulative incidences of bone progression were 75 % ( 48-111 ) , 146 % ( 106-192 ) , 84 % ( 55-122 ) , and 76 % ( 48-112 ) , respectively .
RESULTS	Compared with STAS , STAS plus zoledronic acid increased the risk of bone progression ( SHR 190 , 95 % CI 114-317 ; p = 0012 ) , but no differences were noted with the other two groups .
RESULTS	Cumulative incidence of distant progression was 147 % ( 107-192 ) in the STAS group , 173 % ( 130-221 ) in the STAS plus zoledronic acid group , 142 % ( 103-187 ) in the ITAS group , and 111 % ( 76-152 ) in the ITAS plus zoledronic acid group ; no differences were recorded between groups .
RESULTS	Cumulative incidence of secondary therapeutic intervention was 256 % ( 205-309 ) , 289 % ( 235-345 ) , 207 % ( 161-259 ) , and 153 % ( 113-200 ) , respectively .
RESULTS	Compared with STAS , ITAS plus zoledronic acid reduced the need for secondary therapeutic intervention ( SHR 067 , 95 % CI 048-095 ; p = 0024 ) ; no differences were noted with the other two groups .
RESULTS	An interaction between trial factors was recorded for Gleason score ; therefore , we did pairwise comparisons between all groups .
RESULTS	Post-hoc analyses suggested that the reductions in PSA progression and decreased need for secondary therapeutic intervention with ITAS plus zoledronic acid were restricted to tumours with a Gleason score of 8-10 , and that ITAS was better than STAS in tumours with a Gleason score of 7 or lower .
RESULTS	Long-term morbidity and quality-of-life scores were not affected adversely by 18 months of androgen suppression or zoledronic acid .
CONCLUSIONS	Compared with STAS , ITAS plus zoledronic acid was more effective for treatment of prostate cancers with a Gleason score of 8-10 , and ITAS alone was effective for tumours with a Gleason score of 7 or lower .
CONCLUSIONS	Nevertheless , these findings are based on secondary endpoint data and post-hoc analyses and must be regarded cautiously .
CONCLUSIONS	Long - term follow-up is necessary , as is external validation of the interaction between zoledronic acid and Gleason score .
CONCLUSIONS	STAS plus zoledronic acid can be ruled out as a potential therapeutic option .
BACKGROUND	National Health and Medical Research Council of Australia , Novartis Pharmaceuticals Australia , Abbott Pharmaceuticals Australia , New Zealand Health Research Council , New Zealand Cancer Society , University of Newcastle ( Australia ) , Calvary Health Care ( Calvary Mater Newcastle Radiation Oncology Fund ) , Hunter Medical Research Institute , Maitland Cancer Appeal , Cancer Standards Institute New Zealand .

###25250780
BACKGROUND	Gender dysphoria is characterized by a strong discomfort with the gender assigned at birth and the urge to live as a member of the opposite gender .
BACKGROUND	The acquisition of phenotypic features of the desired gender requires the use of cross-sex hormones .
BACKGROUND	Female-to-male ( FtM ) transsexual persons are treated with testosterone to induce virilization .
OBJECTIVE	The aim of the study was to assess the effects of three different testosterone formulations on body weight and composition and metabolic and bone parameters .
METHODS	Forty-five FtM transsexuals were randomly assigned to receive testoviron depot ( i.m. : 100mg/10 days ; n = 15 ) , testosterone gel ( 50mg/die ; n = 15 ) , and testosterone undecanoate ( i.m. : 1,000 mg every 6 weeks for the first 6 weeks and then every 12 weeks , n = 15 ) .
METHODS	FtM individuals were studied before , at week 30 , and at week 54 of testosterone treatment .
METHODS	Anthropometric , metabolic , bone , hematological , and biochemical parameters were evaluated at baseline and after 12 months of treatment .
RESULTS	Lean body mass significantly increased and fat mass decreased in all groups .
RESULTS	No modifications were reported in fasting insulin and insulin sensitivity index .
RESULTS	High-density plasma lipoprotein levels declined significantly and low-density lipoprotein concentrations increased significantly in the three groups .
RESULTS	The activated partial thromboplastin time and factor I did not change while prothrombin time significantly increased in all groups .
RESULTS	At week 54 , all subjects were amenorrheic and time to amenorrhea did not differ between the three groups .
RESULTS	Current general life satisfaction was increased in all subjects after 1 year of treatment .
CONCLUSIONS	One-year testosterone administration in FtM transsexuals appears to be very safe with no differences among the testosterone formulations used .
CONCLUSIONS	Our study is preliminary , and the detection of subtle or long-term differences in the effects of the three formulations may require further larger and longer term studies in this and other populations .

###24467625
BACKGROUND	Migraine shows gender-specific incidence and has a higher prevalence in females .
BACKGROUND	Gender plays an important role in the prevalence of migraine , but few studies have investigated the effect of gender on the cognitive functions of migraine patients .
BACKGROUND	This study investigated gender differences in the cognitive function of migraine patients without aura .
METHODS	We recruited 29 migraine patients ( 15 females ; mean age 25.4 y ) during the interictal period and 28 healthy age-matched participants ( 14 females ; mean age 24.8 y ) .
METHODS	We used an auditory oddball paradigm to analyze target processing using event-related potentials .
RESULTS	We investigated the N2 and P3 components .
RESULTS	The P3 amplitude was decreased in patients compared with the control , and this reduction was not modulated by gender .
RESULTS	These results of the P3 provided a new evidence for the dysfunction of cognitive function in migraine patients .
RESULTS	The N2 amplitude was larger for male than female migraine patients , and this gender effect was not found in the control group .
CONCLUSIONS	These results of the P3 provided a new evidence for the dysfunction of cognitive function in migraine patients .
CONCLUSIONS	And those of N2 may explain that male patients have the super-sensitivity of cerebral function relevant to the early target-selection and response preparation .
CONCLUSIONS	Our findings emphasize the importance of considering gender when researching the cognitive function of migraine patients .

###25574801
BACKGROUND	Data about the influence of the type of sedation on yield , complications , and tolerance of endobronchial ultrasound-guided transbronchial needle aspiration ( EBUS-TBNA ) are based mostly on retrospective studies and are largely inconsistent .
OBJECTIVE	To determine whether the type of sedation influences the diagnostic yield of EBUS-TBNA , its complication rates , and patient tolerance .
METHODS	Patients referred for EBUS-TBNA were randomized ( 1:1 ) to undergo this procedure under general anesthesia ( GA ) or moderate sedation ( MS ) .
METHODS	Pathologists were blinded to group allocation .
RESULTS	The main outcome was `` diagnostic yield , '' defined as the percentage of patients for whom EBUS-TBNA rendered a specific diagnosis .
RESULTS	One hundred and forty-nine patients underwent EBUS-TBNA , 75 under GA and 74 under MS. Demographic and baseline clinical characteristics were well balanced .
RESULTS	Two hundred and thirty-six lymph nodes ( LNs ) and six masses were sampled in the GA group ( average , 3.2 1.9 sites/patient ) , and 200 LNs and six masses in the MS group ( average , 2.8 1.5 sites/patient ) ( P = 0.199 ) .
RESULTS	The diagnostic yield was 70.7 % ( 53 of 75 ) and 68.9 % ( 51 of 74 ) for the GA group and MS group , respectively ( P = 0.816 ) .
RESULTS	The sensitivity was 98.2 % in the GA group ( confidence interval , 97-100 % ) and 98.1 % in the MS group ( confidence interval , 97-100 % ) ( P = 0.979 ) .
RESULTS	EBUS was completed in all patients in the GA group , and in 69 patients ( 93.3 % ) in the MS group ( P = 0.028 ) .
RESULTS	There were no major complications or escalation of care in either group .
RESULTS	Minor complications were more common in the MS group ( 29.6 vs. 5.3 % ) ( P < 0.001 ) .
RESULTS	Most patients stated they `` definitely would '' undergo this procedure again in both groups ( P = 0.355 ) .
CONCLUSIONS	EBUS-TBNA performed under MS results in comparable diagnostic yield , rate of major complications , and patient tolerance as under GA. .
CONCLUSIONS	Future prospective multicenter studies are required to corroborate our findings .
CONCLUSIONS	Clinical trial registered with www.clinicaltrials.gov ( NCT 01430962 ) .

###25752778
OBJECTIVE	To describe the interindividual variability in physical function responses to supervised resistance and aerobic exercise training interventions in older adults .
METHODS	Data analysis of two randomized , controlled exercise trials .
METHODS	Community-based research centers .
METHODS	Overweight and obese ( body mass index ( BMI ) 27.0 kg/m2 ) sedentary men and women aged 65 to 79 ( N = 95 ) .
METHODS	Five months of 4 d/wk of aerobic training ( AT , n = 40 ) or 3 d/wk of resistance training ( RT , n = 55 ) .
METHODS	Physical function assessments : global measure of lower extremity function ( Short Physical Performance Battery ( SPPB ) ) , 400-m walk , peak aerobic capacity ( VO2 peak ) , and knee extensor strength .
RESULTS	On average , both exercise interventions significantly improved physical function .
RESULTS	For AT , there was a 7.9 % increase in VO2 peak ; individual absolute increases varied from 0.4 to 4.3 mL/kg per minute , and four participants ( 13 % ) showed no change or a decrease in VO2 peak .
RESULTS	For RT , knee extensor strength improved an average of 8.1 % ; individual increases varied from 1.2 to 63.7 Nm , and 16 participants ( 30 % ) showed no change or a decrease in strength .
RESULTS	Usual gait speed , 400-m walk time , chair rise time , and SPPB improved for the majority of AT participants and usual gait speed , chair rise time , and SPPB improved for the majority of RT participants , but there was wide variation in the magnitude of improvement .
RESULTS	Only change in 400-m walk time with RT was related to exercise adherence ( correlation coefficient = -0.31 , P = .004 ) .
CONCLUSIONS	Despite sufficient levels of adherence to both exercise interventions , some participants did not improve function , and the magnitude of improvement varied widely .
CONCLUSIONS	Additional research is needed to identify factors that optimize responsiveness to exercise to maximize its functional benefits in older adults .

###24438351
BACKGROUND	People with multi-drug resistant tuberculosis ( MDR-TB ) in low-income countries face many problems during treatment , and cure rates are low .
BACKGROUND	The purpose of the study was ( a ) to identify and document the problems experienced by people receiving care for MDR-TB , and how they cope when support is not provided , to inform development of strategies ; ( b ) to estimate the effectiveness of two resultant strategies , counselling alone , and joint counselling and financial support , of increasing DOTS-plus treatment success under routine programme conditions .
METHODS	A mixed-method study comprising a formative qualitative study , pilot intervention study and explanatory qualitative study to better understand barriers to completion of treatment for MDR-TB .
METHODS	Participants were all people starting MDR-TB treatment in seven DOTS-plus centres in the Kathmandu Valley , Nepal during January to December 2008 .
METHODS	The primary outcome measure was cure , as internationally defined .
RESULTS	MDR-TB treatment caused extreme social , financial and employment hardship .
RESULTS	Most patients had to move house and leave their job , and reported major stigmatisation .
RESULTS	They were concerned about the long-term effects of their disease , and feared infecting others .
RESULTS	In the resultant pilot intervention study , the two strategies appeared to improve treatment outcomes : cure rates for those receiving counselling , combined support and no support were 85 % , 76 % and 67 % respectively .
RESULTS	Compared with no support , the ( adjusted ) risk ratios of cure for those receiving counselling and receiving combined support were 1.2 ( 95 % CI 1.0 to 1.6 ) and 1.2 ( 95 % CI 0.9 to 1.6 ) respectively .
RESULTS	The explanatory study demonstrated that patients valued both forms of support .
CONCLUSIONS	MDR-TB patients are extremely vulnerable to stigma and extreme financial hardship .
CONCLUSIONS	Provision of counselling and financial support may not only reduce their vulnerability , but also increase cure rates .
CONCLUSIONS	National Tuberculosis Programmes should consider incorporating financial support and counselling into MDR-TB care : costs are low , and benefits high , especially since costs to society of incomplete treatment and potential for incurable TB are extremely high .

###25726515
BACKGROUND	Acute kidney injury often goes unrecognised in its early stages when effective treatment options might be available .
BACKGROUND	We aimed to determine whether an automated electronic alert for acute kidney injury would reduce the severity of such injury and improve clinical outcomes in patients in hospital .
METHODS	In this investigator-masked , parallel-group , randomised controlled trial , patients were recruited from the hospital of the University of Pennsylvania in Philadelphia , PA , USA .
METHODS	Eligible participants were adults aged 18 years or older who were in hospital with stage 1 or greater acute kidney injury as defined by Kidney Disease Improving Global Outcomes creatinine-based criteria .
METHODS	Exclusion criteria were initial hospital creatinine 40 mg/dL ( to convert to mol/L , multiply by 884 ) or greater , fewer than two creatinine values measured , inability to determine the covering provider , admission to hospice or the observation unit , previous randomisation , or end-stage renal disease .
METHODS	Patients were randomly assigned ( 1:1 ) via a computer-generated sequence to receive an acute kidney injury alert ( a text-based alert sent to the covering provider and unit pharmacist indicating new acute kidney injury ) or usual care , stratified by medical versus surgical admission and intensive care unit versus non-intensive care unit location in blocks of 4-8 participants .
METHODS	The primary outcome was a composite of relative maximum change in creatinine , dialysis , and death at 7 days after randomisation .
METHODS	All analyses were by intention to treat .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01862419 .
RESULTS	Between Sept 17 , 2013 , and April 14 , 2014 , 23,664 patients were screened .
RESULTS	1201 eligible participants were assigned to the acute kidney injury alert group and 1192 were assigned to the usual care group .
RESULTS	Composite relative maximum change in creatinine , dialysis , and death at 7 days did not differ between the alert group and the usual care group ( p = 088 ) , or within any of the four randomisation strata ( all p > 005 ) .
RESULTS	At 7 days after randomisation , median maximum relative change in creatinine concentrations was 00 % ( IQR 00-184 ) in the alert group and 06 % ( 00-175 ) in the usual care group ( p = 081 ) ; 87 ( 72 % ) patients in the alert group and 70 ( 59 % ) patients in usual care group had received dialysis ( odds ratio 125 [ 95 % CI 090-174 ] ; p = 018 ) ; and 71 ( 59 % ) patients in the alert group and 61 ( 51 % ) patients in the usual care group had died ( 116 [ 081-168 ] ; p = 040 ) .
CONCLUSIONS	An electronic alert system for acute kidney injury did not improve clinical outcomes among patients in hospital .
BACKGROUND	Penn Center for Healthcare Improvement and Patient Safety .

###25237668
OBJECTIVE	To compare planning and patient rehabilitation using a 3D dental planning software and dedicated surgical guides with conventional rehabilitation of partially or fully edentulous patients using flapless or mini-flap procedures and immediate loading .
METHODS	Fifty-one fully or partially edentulous patients requiring at least 2 implants to be restored with a single prosthesis , having at least 7 mm of bone height and 4 mm in bone width , had their implant rehabilitation planned on three-dimensional ( 3D ) cone beam computed tomography ( CBCT ) scans using a dedicated software .
METHODS	Afterwards they were randomised according to a parallel group study design into two arms : computer-guided implant placement aided with templates ( computer-guided group ) versus conventional implant placement without templates ( conventional group ) in three different centres .
METHODS	Implants were to be placed flapless and loaded immediately ; if inserted with a torque over 35 Ncm with reinforced provisional prostheses , then replaced , after 4 months , by definitive prostheses .
METHODS	Outcome measures , assessed by masked assessors were : prosthesis and implant failures , complications , peri-implant bone level changes , number of treatment sessions , duration of treatment , post-surgical pain and swelling , consumption of pain killers , treatment time , time required to solve complications , additional treatment cost , patient satisfaction .
METHODS	Patients were followed up to 1 year after loading .
RESULTS	Twenty-six patients were randomised to the conventional treatment and 25 to computerguided rehabilitation .
RESULTS	No patient dropped out .
RESULTS	One provisional prosthesis failed , since one of the two supporting implants failed 11 days after implantation in the conventional group ( P = 1.0 ) .
RESULTS	Four patients of the conventionally loaded groups experienced one complication each , versus five patients ( 6 complications ) in the computer-guided group ( P = 0.726 ) .
RESULTS	There were no statistically significant differences between the two groups for any of the tested outcomes with the exception of more postoperative surgical pain ( P = 0.002 ) and swelling ( P = 0.024 ) at conventionally treated patients .
CONCLUSIONS	When treatment planning was made on 3D CBTC scan using a dedicated software , no statistically significant differences were observed between computer-guided and a free-hand rehabilitations , with the exception of more postoperative pain and swelling at sites treated freehand because more frequently flaps were elevated .

###24336671
OBJECTIVE	This study is aimed to identify the expression of Notch family proteins in placentas from patients with early-onset severe preeclampsia .
METHODS	The expression of Notch family proteins in placentas was investigated by immunohistochemistry , Western blotting , and real-time reverse transcription-polymerase chain reaction ( RT-PCR ) .
RESULTS	The profile of distribution of all Notch family proteins in placentas from patients with early-onset severe preeclampsia is similar to that in normal placentas .
RESULTS	All Notch family proteins are expressed in placental trophoblasts .
RESULTS	Moreover , Notch1 and Jagged1 ( Jag1 ) are detected in placental endothelial cells .
RESULTS	Real-time RT-PCR showed that messenger RNA levels of Notch2 and Delta-like4 ( Dll4 ) in placentas from patients with early-onset severe preeclampsia are lower than that of normal placentas .
RESULTS	Western blotting showed a significant increase in Notch3 expression and a significant decrease in Notch2 expression in placentas from patients with early-onset severe preeclampsia relative to those in normal placentas .
CONCLUSIONS	The results suggest that Notch2 and Notch3 may play some roles in the pathogenesis of preeclampsia .

###26480548
OBJECTIVE	To compare the difference in the efficacy between acupuncture and oral administration of trazodone and the expressions of neurotransmitters in patients of insomnia differentiated as liver stagnation transforming into fire .
METHODS	Seventy patients of insomnia differentiated as liver stagnation transforming into fire were randomized into an observation group and a control group , 35 cases in each one .
METHODS	In the observation group , acupuncture therapy was adopted at Shenmen ( HT 7 ) , Baihui ( GV 20 ) , Yintang ( GV 29 ) , Hegu ( LI 4 ) , Taichong ( LR 3 ) , etc. .
METHODS	The needles were retained for 20 min each time .
METHODS	The treatment was given once a day , the treatment of 2 weeks made one session .
METHODS	In the control group , trazodone , 100 mg , oral administration , once a day , the treatment of 2 weeks made one session .
METHODS	Two sessions were required in the two groups .
METHODS	The scores in Pittsburgh sleep quality index ( PSQI ) and Asberg rating scale for side effects ( SERS ) , the levels of neurotransmitters such as 5-hydroxy tryptamine ( 5-HT ) and norepinephrine ( NE ) and the expressions of protein kinase C ( PKC ) and brain-derived neurotrophic factor ( BDNF ) in peripheral blood were observed before and after treatment in the two groups .
RESULTS	PSQI score and SERS score after treatment were all decreased compared with those in both groups before treatment ( both P < 0.05 ) .
RESULTS	After treatment , PSQI score and SERS score in the observation group were lower apparently than those in the control group ( both P < 0.05 ) .
RESULTS	After treatment NE content and PKC level were decreased ; 5-HT content and BDNF mRNA were increased compared with those in both groups before treatment ( all P < 0.05 ) .
RESULTS	NE content and PKC level in the observation group were lower apparently than those in the control group ( both P < 0.05 ) .
RESULTS	The serum 5-HT content and BDNF mRNA expression in the observation group were higher than those in the control group separately ( both P < 0.05 ) .
CONCLUSIONS	Acupuncture therapy improves the sleeping quality of patients of insomnia differentiated as liver stagnation transforming into fire , and reduces serum NE level and increases 5-HT content and BDNF expression , which achieves the better efficacy as compared with the oral administration of trazodone .
CONCLUSIONS	It is one of the effective approaches to the treatment of insomnia differentiated as liver stagnation transforming into fire .

###24673497
BACKGROUND	With the increase in the aging population , there is a pressing need to provide effective treatment options for individuals with Alzheimer 's disease ( AD ) .
BACKGROUND	Memantine is an N-methyl-D-aspartate receptor antagonist used to treat AD in > 80 countries worldwide , and studies in the USA and Europe have shown it to be effective in improving language deficits ; however , there are currently no data on language improvements in Japanese patients treated with memantine .
OBJECTIVE	To clarify the efficacy and safety of memantine in Japanese outpatients with moderate to severe AD , using a pooled analysis of two multicenter randomized placebo-controlled trials , a phase 2 dose-finding study and a phase 3 study .
RESULTS	The final analysis comprised 633 patients ( 318 receiving memantine and 315 placebo ) .
RESULTS	Memantine produced better outcomes in terms of Severe Impairment Battery-Japanese version , Clinician 's Interview-Based Impression of Change plus-Japanese version , Behavioral Pathology in AD Rating Scale , and language scores , versus placebo .
RESULTS	The overall incidence of adverse events and adverse reactions was similar between groups .
CONCLUSIONS	In this pooled analysis of Japanese patients , memantine achieved better outcomes than placebo in terms of cognition , including attention , praxis , visuospatial ability and language , and behavioral and psychological symptoms , including activity disturbances and aggressiveness .

###24568125
BACKGROUND	To improve effectiveness of future screen behaviour interventions , one needs to know whether an intervention works via the proposed mediating mechanisms and whether the intervention is equally effective among subgroups .
BACKGROUND	Parental regulation is identified as a consistent correlate of screen behaviours , but prospective evidence as well as the mediation role of parental regulation is largely lacking .
BACKGROUND	This study investigated post-intervention main effects on screen behaviours in the HEIA-intervention -- a Norwegian school-based multiple-behaviour study , as well as mediation effects of parental regulation by adolescents ' and parents ' report .
BACKGROUND	In addition , moderating effects of gender and weight status on the intervention and mediating effects were explored .
METHODS	Participating schools were randomized to control ( n = 25 ) or intervention ( n = 12 ) condition .
METHODS	Adolescents ( n = 908 Control ; 510 Intervention ) self-reported their weekday and weekend TV-viewing and computer/game-use .
METHODS	Change in adolescents ' behaviours was targeted through school and parents .
METHODS	Adolescents , mothers ( n = 591 Control ; 244 Interventions ) and fathers ( n = 469 Control ; 199 Intervention ) reported parental regulation of the screen behaviours post-intervention ( at 20 month ) .
METHODS	The product-of-coefficient test using linear regression analysis was conducted to examine main and mediating effects .
RESULTS	There was no intervention effect on the screen behaviours in the total sample .
RESULTS	Gender moderated effect on weekend computer/game-use , while weight status moderated the effect on weekday TV-viewing and computer/game-use .
RESULTS	Stratified analyses showed a small favourable intervention effect on weekday TV-viewing among the normal weight .
RESULTS	Parental regulation did not mediate change in the screen behaviours .
RESULTS	However , stronger parental regulation was associated with less TV-viewing and computer/game-use with effects being conditional on adolescents ' versus parental reports .
RESULTS	Parental regulation of the screen behaviours , primarily by the parental report , was associated with change in the respective behaviours .
CONCLUSIONS	Multiple behaviour intervention may not affect all equally well , and the effect may differ by weight status and gender .
CONCLUSIONS	In future interventions parents should be encouraged to regulate their adolescents ' TV-viewing and computer/game-use on both weekdays and weekends as parental regulation was identified as a determinant of these screen behaviours .
CONCLUSIONS	However , future intervention studies may need to search for more effective intervention strategies targeting parental regulation .
BACKGROUND	Current Controlled Trials ISRCTN98552879 .

###25188811
OBJECTIVE	The paper describes recruitment results and characteristics of the UP-TECH clinical trial sample , including level of care services use , informal caregiver burden and its determinants .
METHODS	UP-TECH is designed to test innovative care solutions for community-dwelling patients with moderate stage Alzheimer 's disease and their caregivers in Italy .
METHODS	Four hundred and fifty patient-caregiver dyads were randomized into three arms receiving different combinations of services , composed of case management interventions , nurse visits , assistive technology and educational brochures .
METHODS	The research nurses administered a questionnaire comprising an in-depth socio-demographic assessment and several clinical scales , such as Novak 's Caregiver Burden Inventory .
METHODS	Analyses of baseline data were conducted using uni - and bi-variate statistics .
METHODS	Linear regressions were computed to identify de-confounded correlates of caregiver burden .
RESULTS	Four hundred and thirty-eight patient-caregiver dyads were recruited and randomized .
RESULTS	In our sample , patients are predominantly women ( 71.5 % ) , with an average age of 81.5 years and a mean Mini-Mental State Examination score of 16.2 .
RESULTS	Caregivers are mostly women ( 66.2 % ) and offspring ( 55.7 % ) , with a mean caregiver burden score of 27.6 .
RESULTS	They provide more than 50 hours of care per week , while receiving an almost negligible support from public services .
RESULTS	Factors associated with caregiver burden are female gender , kinship and the patient 's behavioral disturbances .
RESULTS	The most important factor associated with lower burden is the employment of a live-in care worker .
CONCLUSIONS	The paper provides a comprehensive description of moderate stage Alzheimer 's disease patients and their caregivers , suggesting useful markers of caregiver burden .
CONCLUSIONS	The well-balanced randomization assures the reliability of the study data-set for prospective evaluation of care strategies .

###24923723
OBJECTIVE	Right hemisphere stroke patients frequently experience spatial neglect , a severe lack of awareness for contralesional hemispace .
OBJECTIVE	Although neglect counts among the strongest predictors for poor functional outcome after stroke , there is no established therapy , particularly not for the acute stage .
METHODS	In a randomized controlled trial , we compared the combined treatment of hemifield eye patching and repetitive optokinetic stimulation in acute stroke patients with neglect to the spontaneous course .
METHODS	Outcome measures were a neuropsychological test battery for neglect as well as scales of functional independence and clinical impairment .
METHODS	Outcomes were assessed at baseline ( day 1 ) , post treatment ( day 8 ) , and at 1-month follow-up ( day 30 ) .
RESULTS	Final analysis included 21 acute right hemisphere stroke patients with neglect ( 23 enrolled , 2 lost to follow-up ) allocated either to the treatment ( 1 week hemifield eye patching and daily sessions of optokinetic stimulation , n = 11 ) or the control group ( no neglect-specific treatment , n = 10 ) .
RESULTS	At baseline , both groups did not differ in neuropsychological test performance , clinical impairment , or functional disability .
RESULTS	At the post treatment session , both groups had improved in all these measures , and results were stable or further improved at follow-up .
RESULTS	However , there was no significant difference in this change between the treatment and the control group .
CONCLUSIONS	An early intervention of combined hemifield eye patching and optokinetic stimulation in acute stroke patients with spatial neglect has no additive effect to the spontaneous remitting course of the disorder .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT01617343 .

###24481211
BACKGROUND	Hereditary hemorrhagic telangiectasia ( HHT ) is a dominantly inherited genetic vascular disorder in which epistaxis is the most frequent manifestation , responsible for high morbidity .
BACKGROUND	Management of this symptom has no standard , and local treatments are often aggressive .
BACKGROUND	Their efficacy is variable and has not been proven .
BACKGROUND	Anti-angiogenic drugs , such as bevacizumab , are a new treatment strategy .
BACKGROUND	Its systemic administration in patients with HHT improves liver damage-related symptoms and epistaxis .
BACKGROUND	To limit the systemic adverse effects of bevacizumab and to ease administration , a local administration seems suitable .
OBJECTIVE	To evaluate the tolerance of increasing doses of bevacizumab administered as a nasal spray in patients with HHT-related epistaxis .
OBJECTIVE	Secondary objectives were to study the bioavailability and efficacy of bevacizumab against epistaxis when given as a nasal spray .
METHODS	Phase 1 , randomized , double-blind , placebo-controlled , monocentric study performed sequentially ( dose escalation ) on 5 groups of 8 patients .
METHODS	Each group was made up of 6 verum and 2 placebos .
METHODS	Five increasing doses of bevacizumab nasal spray ( 25 mg/mL ) were evaluated : 12.5 , 25 , 50 , 75 and 100 mg .
RESULTS	A total of 40 patients were included between October 2011 and October 2012 .
RESULTS	Bevacizumab nasal spray was well tolerated in all patients and the drug was not detected in their serum .
RESULTS	No dose limiting toxicity was observed .
RESULTS	No efficacy was observed at any dose in this study .
CONCLUSIONS	Based on these results , bevacizumab nasal spray is a safe treatment of epistaxis in HHT .
CONCLUSIONS	However , a randomized Phase 2 study is needed to determine its efficacy .
BACKGROUND	ClinicalTrials.gov Identifier #NCT 01507480 .

###24581825
BACKGROUND	Bipolar depression is one of the most serious psychiatric conditions .
BACKGROUND	In addition , sleep disturbance in bipolar disorder is common , and therapeutic agents restoring sleep disturbances in bipolar disorder patients will be clinically beneficial .
BACKGROUND	In the current study , we compared the effect of quetiapine XR with lithium on depressive symptoms and sleep in bipolar depression patients during 8 weeks of trial .
METHODS	An open-label , randomized comparison of sleep-activity and depressive symptoms between 8-week quetiapine XR monotherapy and lithium monotherapy for bipolar depression was conducted .
METHODS	Each assessment consisted of HDRS-17 , Clinical Global Impression-severity ( CGI-S ) , and self-reported Pittsburgh Sleep Quality Index ( PSQI ) .
METHODS	Actigraphy-measured sleep parameters were assessed .
RESULTS	A total of 42 patients ( 35.710.9 years ; gender : male 15 , female 27 ) with bipolar depression were screened out .
RESULTS	Out of 42 patients , six patients were excluded before randomization .
RESULTS	After randomization , seven patients were withdrawn .
RESULTS	Twenty-nine patients with more than two visits after randomization ( lithium group : 17 , quetiapine XR group : 12 , mean age : 36.110.4 , gender : male 13 , female 16 ) were included in the final analysis .
RESULTS	In both groups , Hamilton Depression Rating Scale ( HDRS ) scores were significantly decreased at weeks 1 , 2 , 4 , 6 , and 8 compared with baseline .
RESULTS	Remission rate ( HDRS7 ) in the quetiapine XR was significantly higher than that of the lithium group .
RESULTS	In the quetiapine XR group , PSQI scores at weeks 1 , 2 , 4 , 6 , and 8 was significantly decreased compared with baseline .
RESULTS	Sleep efficiency at weeks 6 and 8 was significantly increased .
RESULTS	WASO at week 8 was significantly decreased .
CONCLUSIONS	First , the present study was conducted with the relatively small number of study subjects .
CONCLUSIONS	Second , bias could have affected the study results due to its open-label design .
CONCLUSIONS	Third , study subjects were made up of high proportion of bipolar II disorder patients .
CONCLUSIONS	Quetiapine XR monotherapy was more effective in treating bipolar depression than lithium .
CONCLUSIONS	In particular , quetiapine XR treatment improved both subjective and objective sleep quality in patients with bipolar depression .
CONCLUSIONS	However , relationship between favorable sleep quality and depressive symptom improvement were limited .

###24247643
OBJECTIVE	To analyse the clinical significance and related factors of thirst and xerostomia and to find methods to alleviate thirst and xerostomia in maintenance hemodialysis ( MHD ) patients .
METHODS	Forty-two MHD patients were included for observational study and eleven patients were enrolled for crossover trial .
METHODS	Thirst was assessed by 100-mm visual analog scales ( VAS ) and dialysis thirst inventory ( DTI ) .
METHODS	Meanwhile , xerostomia was assessed by VAS and xerostomia inventory ( XI ) .
METHODS	Depression , kidney disease quality of life ( KDQOL ) , salivary flow rates and inter dialytic weight gain ( IDWG ) were measured .
METHODS	Data were analyzed by ANOVA and correlation coefficient was used to assess the correlations between continuous variables .
METHODS	The results of crossover trial were investigated by two-sample T-tests .
RESULTS	Strong positive correlations among DTI , VAS thirst score , XI and VAS xerostomia score were found ( P = 0.000 ) .
RESULTS	Daily IDWG was positively correlated with VAS thirst score ( r = 0.315 , P = 0.042 ) and DTI ( r = 0.391 , P = 0.010 ) .
RESULTS	UWS ( unstimulated whole saliva ) was negatively correlated with VAS xerostomia score ( r = -0.308 , P = 0.048 ) .
RESULTS	Residual urine output was negatively correlated with DTI ( r = -0.402 , P = 0.008 ) , VAS xerostomia score ( r = -0.461 , P = 0.002 ) and XI ( r = -0.403 , P = 0.008 ) .
RESULTS	In the crossover trial , DTI , XI , IDWG2d , IDWG3d , VAS thirst and xerostomia score were significantly reduced by the use of chewing gum ( P = 0.000 , 0.001 , 0.009 , 0.017 , 0.038 , 0.001 ) .
RESULTS	The VAS thirst score , DTI and IDWG3d were significantly reduced by receiveing straw ( P = 0.016 , 0.003 , 0.049 ) .
CONCLUSIONS	Thirst and xerostomia might affect the quality of life in MHD patients .
CONCLUSIONS	Both chewing gum and straw could decrease thirst and IDWG .

###24297940
OBJECTIVE	Cytarabine plays a pivotal role in the treatment of patients with acute myeloid leukemia ( AML ) .
OBJECTIVE	Most centers use 7 to 10 days of cytarabine at a daily dose of 100 to 200 mg/m ( 2 ) for remission induction .
OBJECTIVE	Consensus has not been reached on the benefit of higher dosages of cytarabine .
METHODS	The European Organisation for Research and Treatment of Cancer ( EORTC ) and Gruppo Italiano Malattie Ematologiche dell ' Adulto ( GIMEMA ) Leukemia Groups conducted a randomized trial ( AML-12 ; Combination Chemotherapy , Stem Cell Transplant and Interleukin-2 in Treating Patients With Acute Myeloid Leukemia ) in 1,942 newly diagnosed patients with AML , age 15 to 60 years , comparing remission induction treatment containing daunorubicin , etoposide , and either standard-dose ( SD ) cytarabine ( 100 mg/m ( 2 ) per day by continuous infusion for 10 days ) or high-dose ( HD ) cytarabine ( 3,000 mg/m ( 2 ) every 12 hours by 3-hour infusion on days 1 , 3 , 5 , and 7 ) .
METHODS	Patients in complete remission ( CR ) received a single consolidation cycle containing daunorubicin and intermediate-dose cytarabine ( 500 mg/m ( 2 ) every 12 hours for 6 days ) .
METHODS	Subsequently , a stem-cell transplantation was planned .
METHODS	The primary end point was survival .
RESULTS	At a median follow-up of 6 years , overall survival was 38.7 % for patients randomly assigned to SD cytarabine and 42.5 % for those randomly assigned to HD cytarabine ( log-rank test P = .06 ; multivariable analysis P = .009 ) .
RESULTS	For patients younger than age 46 years , survival was 43.3 % and 51.9 % , respectively ( P = .009 ; multivariable analysis P = .003 ) , and for patients age 46 to 60 years , survival was 33.9 % and 32.9 % , respectively ( P = .91 ) .
RESULTS	CR rates were 72.0 % and 78.7 % , respectively ( P < .001 ) and were 75.6 % and 82.4 % for patients younger than age 46 years ( P = .01 ) and 68.3 % and 74.8 % for patients age 46 years and older ( P = .03 ) .
RESULTS	Patients of all ages with very-bad-risk cytogenetic abnormalities and/or FLT3-ITD ( internal tandem duplication ) mutation , or with secondary AML benefitted from HD cytarabine .
CONCLUSIONS	HD cytarabine produces higher remission and survival rates than SD cytarabine , especially in patients younger than age 46 years .

###24950270
BACKGROUND	Laparoscopic sphincter preservation for low rectal cancer is challenging because of the high risk of positive circumferential resection margin .
BACKGROUND	We hypothesized that perineal dissection of the distal rectum may improve quality of surgery , compared with the conventional abdominal dissection .
METHODS	Between 2008 and 2012 , 100 patients with low rectal cancer ( < 6 cm from the anal verge ) suitable for sphincter preservation were randomized between perineal and abdominal low rectal dissection .
METHODS	Surgery included laparoscopic mobilization of the left colon with high rectal dissection .
METHODS	Distal rectal dissection was performed laparoscopically in the abdominal group and transanally in the perineal group .
METHODS	The primary endpoint was quality of surgery ( circumferential resection margin , mesorectum grade , and lymph nodes ) .
METHODS	Secondary end points were morbidity and conversion .
RESULTS	The rate of positive circumferential resection margin decreased significantly after perineal compared with abdominal low rectal dissection , 4 % versus 18 % ( P = 0.025 ) .
RESULTS	The mesorectum grade and the number of lymph nodes analyzed did not differ between the 2 groups .
RESULTS	There was no difference in surgical morbidity ( 12 % vs 14 % ; P = 0.766 ) and conversion ( 4 % vs 10 % ; P = 0.436 ) between perineal and abdominal rectal dissection .
RESULTS	Multivariate analysis showed that abdominal rectal dissection was the only independent factor of positive circumferential resection margin ( odds ratio = 5.25 ; 95 % confidence interval : 1.03-26 .70 ; P = 0.046 ) .
CONCLUSIONS	Perineal rectal dissection reduces the risk of positive circumferential resection margin , as compared with the conventional abdominal dissection in low rectal cancer .
CONCLUSIONS	This suggests the perineal rectal dissection as a new standard in laparoscopic sphincter-saving resection for low rectal cancer .

###24598043
BACKGROUND	The objective of this prospective , multicenter study was to assess 1-year changes in sinonasal symptoms and health care use after office-based multisinus balloon dilation .
METHODS	Adults diagnosed with chronic or recurrent acute rhinosinusitis per the 2007 adult sinusitis guidelines were enrolled in this Institutional Review Board-approved study .
METHODS	Balloon dilation of the maxillary sinuses/ethmoid infundibula with or without frontal or sphenoid ostial dilation was performed in the physician 's office under local anesthesia .
METHODS	Intraoperative procedure technical success and subject procedure tolerance were recorded .
METHODS	Efficacy was assessed using the patient-reported 20-item Sino-Nasal Outcome Test ( SNOT-20 ) and Rhinosinusitis Symptom Inventory ( RSI ) .
METHODS	Complications and revision surgeries were also recorded .
RESULTS	A total of 313 ostial dilations were attempted and 307 were successfully completed ( 98.1 % ) in 81 subjects .
RESULTS	Mean procedure tolerance was 2.8 2.2 ( 0 = no pain ; 10 = severe pain ) .
RESULTS	Clinically meaningful and statistically significant ( p < 0.0001 ) mean SNOT-20 symptom improvement was observed at 1 and 6 months and sustained through 1 year .
RESULTS	The RSI treatment effect for all major rhinosinusitis symptoms was `` large '' and improvement in each was significant ( p < 0.0001 ) .
RESULTS	Compared with the previous 1-year period , patients reported an average of 2.3 fewer acute sinus infections ( p < 0.0001 ) , 2.4 fewer antibiotic courses taken ( p < 0.0001 ) , and 3.0 fewer sinus-related physician visits ( p < 0.0001 ) after balloon dilation .
RESULTS	No serious device or procedure-related adverse events occurred .
RESULTS	One subject ( 1.3 % ) underwent revision surgery .
CONCLUSIONS	In-office , multisinus balloon dilation is safe , effective , and well tolerated .
CONCLUSIONS	Patients reported significant reductions in both sinonasal symptoms and health care use after balloon dilation .
CONCLUSIONS	Efficacy observed at 1 and 6 month follow-up was sustained through 1 year with a very low rate of revision surgery .
CONCLUSIONS	This study was a part of the clinical trial NCT01612780 registered at www.clinicaltrials.gov .

###25133840
OBJECTIVE	The present study tested whether taking into account both the reflective and the impulsive processes of physical activity ( PA ) is helpful in understanding how , and for whom , PA-promoting messages will be ( in ) effective in changing behavior .
METHODS	Participants ( N = 101 ) were presented with a persuasive message promoting either PA ( experimental condition ) or healthy eating ( control condition ) .
METHODS	Reflective intentions to be physically active were assessed both at baseline and after exposure to the message .
METHODS	Impulsive approach tendencies toward PA ( IAPA ) and sedentary behaviors ( IASB ) were assessed using a manikin task .
METHODS	The main outcome variable was accelerometer-assessed free time spent in moderate to vigorous physical activity ( MVPA ) over 1 week after exposure to the message .
RESULTS	Although the PA-promoting message had no direct effect on MVPA , the results showed that ( a ) this message increased intentions to practice PA , notably among participants with low or moderate ( but not high ) baseline intentions ; ( b ) objective MVPA was positively predicted by postmessage PA intentions and IAPA , and negatively predicted by IASB ; and ( c ) postmessage PA intentions predicted MVPA for individuals with low or moderate ( but not high ) IASB .
RESULTS	A follow-up moderated mediation analysis corroborated these earlier results , showing that PA-promoting messages positively predicted MVPA through postmessage intentions only among individuals with low or moderate baseline intentions and low or moderate IASB .
CONCLUSIONS	By identifying 2 boundary conditions , this study revealed important insights in explaining when PA-promoting messages will be effective to predict objective MVPA and when they will not .

###24642082
BACKGROUND	Improving the use ( eg , initial visit and revisits ) of Internet-delivered interventions to promote healthy lifestyles such as non-smoking is one of the largest challenges in the field of eHealth .
BACKGROUND	Prompts have shown to be effective in stimulating reuse of Internet-delivered interventions among adults and adolescents .
BACKGROUND	However , evidence concerning effectiveness of prompts to promote reuse of a website among children is still scarce .
OBJECTIVE	The aim of this study is to investigate ( 1 ) whether prompts are effective in promoting reuse of an intervention website containing information on smoking prevention for children , ( 2 ) whether the content of the prompt is associated with its effect in terms of reuse , and ( 3 ) whether there are differences between children who do or do not respond to prompts .
METHODS	The sample of this cluster-randomized study consisted of 1124 children ( aged 10-11 years ) from 108 Dutch primary schools , who were assigned to the experimental group of an Internet-delivered smoking prevention intervention study .
METHODS	All participants completed a Web-based questionnaire on factors related to ( non - ) smoking .
METHODS	Schools were randomized to a no-prompt group ( n = 50 ) or a prompt group ( n = 58 ) .
METHODS	All children could revisit the intervention website , but only the children in the prompt group received email and SMS prompts to revisit the website .
METHODS	Those prompt messages functioned as a teaser to stimulate reuse of the intervention website .
METHODS	Reuse of the website was objectively tracked by means of a server registration system .
METHODS	Repeated measures analysis of variance and linear regression analysis were performed to assess the effects of prompts on website reuse and to identify individual characteristics of participants who reuse the intervention website .
RESULTS	Children in the prompt group reused the intervention website significantly more often compared to children in the no-prompt group ( B = 1.56 , P < .001 ) .
RESULTS	Prompts announcing new animated videos ( F1 ,1122 = 9.33 , P = .002 ) and games about ( non - ) smoking on the website ( F1 ,1122 = 8.28 , P = .004 ) resulted in most reuse of the website .
RESULTS	Within the prompt group , children with a low socioeconomic status ( SES ) reused the intervention website more often ( B = 2.19 , P < .001 ) than children of high SES ( B = 0.93 , P = .005 ) .
CONCLUSIONS	Prompts can stimulate children to reuse an intervention website aimed at smoking prevention .
CONCLUSIONS	Prompts showed , furthermore , to stimulate children of a low SES slightly more to reuse an intervention website , which is often a difficult target group in terms of stimulating participation .
CONCLUSIONS	However , the number of revisits was quite low , which requires further study into how prompts can be optimized in terms of content and frequency to improve the number of revisits .
BACKGROUND	Netherlands Trial Register Number : NTR3116 ; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3116 ( Archived by WebCite at http://www.webcitation.org/6O0wQYuPI ) .

###24588456
BACKGROUND	Radial artery catheterization is gaining popularity for diagnostic and interventional procedures .
BACKGROUND	Palpation technique is widely used for the procedure , but ultrasonography has been shown to increase catheterization success .
BACKGROUND	A recently described ultrasonography technique is termed ` dynamic needle tip positioning ' .
BACKGROUND	We aimed to compare the traditional palpation technique and dynamic needle tip positioning technique in regard to clinically relevant end points .
METHODS	The study was conducted as a randomized , patient-blinded , crossover study .
METHODS	Patients underwent bilateral radial artery catheterization using both techniques .
METHODS	The primary end point of the study was needle manipulation time .
METHODS	Additional end points were ( 1 ) the number of skin perforations , ( 2 ) the number of attempts targeting the vessel , ( 3 ) the number of catheters placed in first attempt and ( 4 ) the number of catheters used .
RESULTS	Forty patients were analyzed .
RESULTS	There was no significant difference in median needle manipulation time [ 32 s ( range 11-96 s ) vs. 39 s ( range 9-575 s ) , P = 0.525 ] , although the variance was lower in the dynamic needle tip positioning group ( P < 0.001 ) .
RESULTS	In the traditional palpation technique group , a higher number of skin perforations ( 57 vs. 40 , P = 0.003 ) , catheters ( 46 vs. 40 , P = 0.025 ) and attempts targeting the vessel ( 104 vs. 43 , P < 0.001 ) were necessary compared with the ultrasonography dynamic needle tip positioning group .
RESULTS	First attempt success rate was significantly higher in the ultrasonography dynamic needle tip positioning group ( 23/40 vs. 38/40 , P < 0.001 ) .
CONCLUSIONS	Ultrasonography guidance using the dynamic needle tip positioning technique for radial artery catheterization significantly improves clinically relevant aspects of the procedure .

###24958315
BACKGROUND	Postoperative pain control after total knee arthroplasty ( TKA ) remains a great challenge .
BACKGROUND	The management of pain in the immediate postoperative period is one of the most critical aspects to allow speedier rehabilitation and reduce the risk of postoperative complications .
BACKGROUND	Recently , periarticular infiltration anesthesia has become popular , but the outcome is controversial .
BACKGROUND	Some studies have shown transient effects , `` rebound pain '' , or no effectiveness in pain control .
BACKGROUND	Continuous intra-articular infusion technique has been introduced to improve these transient effects , but more clinical studies are needed .
BACKGROUND	Furthermore , the potential risk of early periprosthetic joint infection is causing concerning .
BACKGROUND	We plan to compare continuous intra-articular infusion anesthesia with epidural infusion anesthesia after TKA to assess the effectiveness of this technique in reducing pain , in improving postoperative function , and to look at the evidence for risk of early infection .
METHODS	This trial is a randomized , controlled study .
METHODS	Patients ( n = 214 ) will be randomized into two groups : to receive continuous intra-articular infusion anesthesia ( group C ) ; and epidural infusion anesthesia ( group E ) .
METHODS	For the first 3 postoperative days , pain at rest , active range of motion ( A-ROM ) , rescue analgesia and side effects will be recorded .
METHODS	At 3-month and 6-month follow-up , A-ROM , C-reactive protein , erythrocyte sedimentation rate , and synovial fluid cell count and culture will be analyzed .
CONCLUSIONS	The results from this study will provide clinical evidence on the efficacy of a continuous intra-articular infusion technique in reducing pain , postoperative functional improvement and safety .
CONCLUSIONS	It will be the first randomized controlled trial to investigate infection risk with local anesthesia after TKA .
BACKGROUND	ClinicalTrials.gov identifier : ChiCTR-TRC-13003999 .

###25697911
BACKGROUND	Observational studies have shown that attentional bias for smoking-related cues is associated with increased craving and relapse .
BACKGROUND	Laboratory experiments have shown that manipulating attentional bias may change craving .
BACKGROUND	Interventions to reduce attentional bias could reduce relapse in smokers seeking to quit .
BACKGROUND	We report a clinical trial of attentional retraining in treatment-seeking smokers .
METHODS	This was a double-blind randomised controlled trial that took place in UK smoking cessation clinics .
METHODS	Smokers interested in quitting were randomised to five weekly sessions of attentional retraining ( N = 60 ) or placebo training ( N = 58 ) using a modified visual probe task from one week prior to quit day .
METHODS	Both groups received 21 mg nicotine patches ( from quit day onwards ) and behavioural support .
METHODS	Primary outcomes included change in attentional bias reaction times four weeks after quit day on the visual probe task and craving measured weekly using the Mood and Physical Symptoms Scale .
METHODS	Secondary outcomes were changes in withdrawal symptoms , time to first lapse and prolonged abstinence .
RESULTS	No attentional bias towards smoking cues was found in the sample at baseline ( mean difference = 3 ms , 95 % CI = -2 , 9 ) .
RESULTS	Post-training bias was not significantly lower in the retraining group compared with the placebo group ( mean difference = -9 ms , 95 % CI = -20 , 2 ) .
RESULTS	There was no difference between groups in change in craving ( p = 0.89 ) and prolonged abstinence at four weeks ( risk ratio = 1.00 , 95 % CI = 0.70 , 1.43 ) .
CONCLUSIONS	Taken with one other trial , there appears to be no effect from clinic-based attentional retraining using the visual probe task .
CONCLUSIONS	Attentional retraining conducted out of clinic may prove more effective .
BACKGROUND	UK Clinical Trials ISRCTN 54375405 .

###25389698
BACKGROUND	During team athletic events , athletic trainers commonly provide fluids with water bottles .
BACKGROUND	When a limited number of water bottles exist , various techniques are used to deliver fluids .
OBJECTIVE	To determine whether fluid delivered via water-bottle administration influenced fluid consumption and hydration status .
METHODS	Crossover study .
METHODS	Outdoor field ( 22.2 C 3.5 C ) .
METHODS	Nineteen participants ( 14 men , 5 women , age = 30 10 years , height = 176 8 cm , mass = 72.5 10 kg ) were recruited from the university and local running clubs .
METHODS	The independent variable was fluid delivery with 3 levels : self-administration with mouth-to-bottle direct contact ( SA-DC ) , self-administration with no contact between mouth and bottle ( SA-NC ) , and external administration with no contact between the mouth and the bottle ( EA-NC ) .
METHODS	Participants warmed up for 10 minutes before completing 5 exercise stations , after which an ad libitum fluid break was given , for a total of 6 breaks .
METHODS	We measured the fluid variables of total volume consumed , total number of squirts , and average volume per squirt .
METHODS	Hydration status via urine osmolality and body-mass loss , and perceptual variables for thirst and fullness were recorded .
METHODS	We calculated repeated-measures analyses of variance to assess hydration status , fluid variables , and perceptual measures to analyze conditions across time .
RESULTS	The total volume consumed for EA-NC was lower than for SA-DC ( P = .001 ) and SA-NC ( P = .001 ) .
RESULTS	The total number of squirts for SA-DC was lower than for SA-NC ( P = .009 ) .
RESULTS	The average volume per squirt for EA-NC was lower than for SA-DC ( P = .020 ) and SA-NC ( P = .009 ) .
RESULTS	Participants arrived ( 601.0 21.3 mOsm/L ) and remained ( 622.3 38.3 mOsm/L ) hydrated , with no difference between conditions ( P = .544 ) ; however , the EA-NC condition lost more body mass than did the SA-DC condition ( P = .001 ) .
RESULTS	There was no main effect for condition on thirst ( P = .147 ) or fullness ( P = .475 ) .
CONCLUSIONS	External administration of fluid decreased total volume consumed via a decreased average volume per squirt .
CONCLUSIONS	The SA-DC method requires fewer squirts within a specific time frame .
CONCLUSIONS	Fluid breaks every 15 minutes resulted in maintenance of euhydration ; however , loss of body mass was influenced by fluid administration .
CONCLUSIONS	Athletic trainers should avoid external administration to promote positive hydration behaviors .
CONCLUSIONS	When fluid is self-administered , individual bottles may be the best clinical practice because more volume can be consumed per squirt .

###24237968
OBJECTIVE	To compare the effects of alfaxalone and propofol on intraocular ( IOP ) pressure in the canine eye .
METHODS	Twenty-three healthy adult dogs .
METHODS	Dogs were randomized to receive intravenous propofol ( n = 11 ) or alfaxalone ( n = 12 ) until loss of jaw tone , 20 min after intravenous premedication ( acepromazine 0.02-0 .03 mg/kg and hydromorphone 0.05-0 .1 mg/kg ) .
METHODS	IOP was measured at baseline ( BL ) , 20 min postpremedication ( postpremed ) , loss of jaw tone ( postinduct ) , and immediately following orotracheal intubation ( postintub ) .
METHODS	Between - and within-treatment effects were analyzed with two-way and one-way repeated measures ANOVA with Bonferroni 's post hoc test , respectively .
METHODS	P < 0.05 was considered significant .
RESULTS	No significant IOP differences were detected between alfaxalone or propofol groups at any time point ( P > 0.05 ) .
RESULTS	Propofol : IOP did not change between BL ( 15.5 2.7 mmHg ) and postpremed ( 16.2 3.6 mmHg , P > 0.05 ) , or postinduct ( 19.1 5.2 mmHg ) and postintub ( 21.0 4.6 mmHg , P > 0.05 ) , but differed significantly between BL and postinduct ( P < 0.0001 ) , and postintub ( P < 0.0001 ) .
RESULTS	Alfaxalone : IOP did not change between BL ( 15.7 2.8 mmHg ) and postpremed ( 15.3 4.1 mmHg , P > 0.05 ) , or postinduct ( 19.2 4.9 mmHg ) and postintub ( 20.5 4.5 mmHg , P > 0.05 ) , but differed significantly between BL and postinduct ( P < 0.01 ) , and postintub ( P < 0.0001 ) .
CONCLUSIONS	These data show a potentially clinically significant increase in IOP following induction with propofol or alfaxalone , but no difference between agents .

###24228748
OBJECTIVE	Infantile colic is a painful condition in the first months of infancy .
OBJECTIVE	Acupuncture is used in Scandinavia as a treatment for infantile colic .
OBJECTIVE	A randomized controlled trial was carried out with the aim of testing the hypothesis that acupuncture treatment has a clinically relevant effect for this condition .
METHODS	A prospective , blinding-validated , randomized controlled multicentre trial in general practice .
METHODS	Research assistants and parents were blinded .
METHODS	13 GPs ' offices in Southern Norway .
METHODS	Three days of bilateral needling of the acupuncture point ST36 , with no treatment as control .
METHODS	113 patients were recruited ; 23 patients were excluded , and 90 randomized ; 79 diaries and 84 interviews were analysed .
METHODS	Difference in changes in crying time during the trial period between the intervention and control group .
RESULTS	The blinding validation questions showed a random distribution with p = 0.41 and 0.60 , indicating true blinding .
RESULTS	We found no statistically significant difference in crying time reduction between acupuncture and control group at any of the measured intervals , nor in the main analysis of differences in changes over time ( p = 0.26 ) .
RESULTS	There was a tendency in favour of the acupuncture group , with a non-significant total baseline-corrected mean of 13 minutes ( 95 % CI -24 to + 51 ) difference in crying time between the groups .
RESULTS	This was not considered clinically relevant , according to protocol .
CONCLUSIONS	This trial of acupuncture treatment for infantile colic showed no statistically significant or clinically relevant effect .
CONCLUSIONS	With the current evidence , the authors suggest that acupuncture for infantile colic should be restricted to clinical trials .

###24445389
BACKGROUND	Endometrial biopsy is a common procedure for the investigation of many gynecological disorders including abnormal uterine bleeding , postmenopausal bleeding , abnormal cytology and infertility .
BACKGROUND	Most women experience some degree of discomfort and pain during the procedure .
BACKGROUND	Pain may occur during dilation of the cervix for insertion of the catheter and during endometrial biopsy , which further aggravates pain by inducing uterine contraction .
OBJECTIVE	To determine pain levels during endometrial biopsy by comparing intrauterine instillation of levobupivacaine or lidocaine with placebo in a randomized , double-blinded trial in pre - and postmenopausal women .
METHODS	Ninety patients were allocated to either control or experimental groups before endometrial biopsy .
METHODS	The trial medication was intrauterine anesthesia , either 5 mL 0.9 % saline ( control group ) , or 5 mL 0.5 % levobupivacaine or 2 % lidocaine ( experimental groups ) .
METHODS	Resident doctors used the same endometrial biopsy technique to minimize the risk of technical variation .
METHODS	All tissue specimens were sent for cytopathological examination .
METHODS	The pathologists , who were blinded to the study solution , analyzed all tissue specimens .
METHODS	The primary outcome measure was pain experienced during the procedure .
METHODS	Pain was assessed using a 10 cm visual analogue pain scale .
METHODS	All observed adverse effects were recorded until the patients were discharged .
RESULTS	Pain scores of the intrauterine lidocaine and levobupivacaine groups were found to be significantly lower than the control group .
RESULTS	There was no difference between the levobupivacaine and lidocaine groups with regard to pain scores .
RESULTS	There was a moderately positive correlation between pain scores and endometrial thickness .
RESULTS	No complications were observed due to the procedure .
RESULTS	Most of the biopsy results were proliferative and secretory endometrium .
RESULTS	Insufficient material causing inconclusive results was observed mostly in the control group .
CONCLUSIONS	Transcervical intrauterine topical instillation of levobupivacaine or lidocaine causes pain relief during endometrial biopsy .
CONCLUSIONS	However , further studies are needed to evaluate the effectiveness of intrauterine anesthesia , to determine optimal concentration , volume and waiting time according to the type of local anesthetic agent , and to assess the applicability of the method to other intrauterine procedures .

###25141536
OBJECTIVE	The present study aimed to compare the effectiveness of the treatment programs of home-based exercise with and without self-manual therapy in individuals with knee osteoarthritis ( knee OA ) in community .
METHODS	Forty-three participants with knee OA were randomly assigned in groups .
METHODS	All participants received the same home-based exercise program with or without self-manual therapy over 12 weeks .
METHODS	Outcome measures were pain intensity , range of motions , six-minute walk test distance , the knee injury and osteoarthritis outcome score ( KOOS ) , short-form 36 ( SF-36 ) and satisfaction .
RESULTS	The results showed that the self-manual therapy program significantly decreased pain at 4 weeks , increased flexion and extension at 4 and 12 weeks , and improved the KOOS in pain item and SF-36 in physical function and mental health items .
RESULTS	The home-based exercise group showed significant increase of the six-minute walk distance at 4 and 12 weeks , improvements in the KOOS in pain and symptom items and SF-36 in the physical function and role-emotional items .
CONCLUSIONS	Overall , the results favored a combination of self-manual therapy and home-based exercise for patients with knee OA , which apparently showed superior benefits in decreasing pain and improving active knee range of motions .

###24548866
BACKGROUND	Central venous access devices in fluoropyrimidine therapy are associated with complications ; however , reliable data are lacking regarding their natural history , associated complications and infusion pump performance in patients with metastatic colorectal cancer .
METHODS	We assessed device placement , use during treatment , associated clinical outcomes and infusion pump performance in the NO16966 trial .
RESULTS	Device replacement was more common with FOLFOX-4 ( 5-fluorouracil ( 5-FU ) + oxaliplatin ) than XELOX ( capecitabine + oxaliplatin ) ( 14.1 % vs 5.1 % ) .
RESULTS	Baseline device-associated events and post-baseline removal - / placement-related events occurred more frequently with FOLFOX-4 than XELOX ( 11.5 % vs 2.4 % and 8.5 % vs 2.1 % ) .
RESULTS	Pump malfunctions , primarily infusion accelerations in 16 % of patients , occurred within 1.6-4 .3 % of cycles .
RESULTS	Fluoropyrimidine-associated grade 3/4 toxicity was increased in FOLFOX-4-treated patients experiencing a malfunction compared with those who did not ( 97 out of 155 vs 452 out of 825 patients ) , predominantly with increased grade 3/4 neutropenia ( 53.5 % vs 39.8 % ) .
RESULTS	Febrile neutropenia rates were comparable between patient cohortsmalfunction .
RESULTS	Efficacy outcomes were similar in patient cohortsmalfunction .
CONCLUSIONS	Central venous access device removal or replacement was common and more frequent in patients receiving FOLFOX-4 .
CONCLUSIONS	Pump malfunctions were also common and were associated with increased rates of grade 3/4 haematological adverse events .
CONCLUSIONS	Oral fluoropyrimidine-based regimens may be preferable to infusional 5-FU based on these findings .

###24252125
BACKGROUND	Primary care provides most of the evidence-based chronic disease prevention and screening services offered by the healthcare system .
BACKGROUND	However , there remains a gap between recommended preventive services and actual practice .
BACKGROUND	This trial ( the BETTER Trial ) aimed to improve preventive care of heart disease , diabetes , colorectal , breast and cervical cancers , and relevant lifestyle factors through a practice facilitation intervention set in primary care .
METHODS	Pragmatic two-way factorial cluster RCT with Primary Care Physicians ' practices as the unit of allocation and individual patients as the unit of analysis .
METHODS	The setting was urban Primary Care Team practices in two Canadian provinces .
METHODS	Eight Primary Care Team practices were randomly assigned to receive the practice-level intervention or wait-list control ; 4 physicians in each team ( 32 physicians ) were randomly assigned to receive the patient-level intervention or wait-list control .
METHODS	Patients randomly selected from physicians ' rosters were stratified into two groups : 1 ) general and 2 ) moderate mental illness .
METHODS	The interventions involved a multifaceted , evidence-based , tailored practice-level intervention with a Practice Facilitator , and a patient-level intervention involving a one-hour visit with a Prevention Practitioner where patients received a tailored ` prevention prescription ' .
METHODS	The primary outcome was a composite Summary Quality Index of 28 evidence-based chronic disease prevention and screening actions with pre-defined targets , expressed as the ratio of eligible actions at baseline that were met at follow-up .
METHODS	A cost-effectiveness analysis was conducted .
RESULTS	789 of 1,260 ( 63 % ) eligible patients participated .
RESULTS	On average , patients were eligible for 8.96 ( SD 3.2 ) actions at baseline .
RESULTS	In the adjusted analysis , control patients met 23.1 % ( 95 % CI : 19.2 % to 27.1 % ) of target actions , compared to 28.5 % ( 95 % CI : 20.9 % to 36.0 % ) receiving the practice-level intervention , 55.6 % ( 95 % CI : 49.0 % to 62.1 % ) receiving the patient-level intervention , and 58.9 % ( 95 % CI : 54.7 % to 63.1 % ) receiving both practice - and patient-level interventions ( patient-level intervention versus control , P < 0.001 ) .
RESULTS	The benefit of the patient-level intervention was seen in both strata .
RESULTS	The extra cost of the intervention was $ 26.43 CAN ( 95 % CI : $ 16 to $ 44 ) per additional action met .
CONCLUSIONS	A Prevention Practitioner can improve the implementation of clinically important prevention and screening for chronic diseases in a cost-effective manner .

###24906602
BACKGROUND	The aim of this study was to assess the impact of digital versus traditional drainage devices on chest tube removal and patient satisfaction .
METHODS	A randomized trial of digital versus traditional devices after lobectomy/segmentectomy was conducted at 4 international centers ( United Kingdom , Europe , Asia , United States ) .
METHODS	Patients were managed with overnight suction followed by gravity drainage .
METHODS	Chest tubes were removed when an air leak was not evident anymore and the drained fluid was less than 400 mL/d .
RESULTS	The groups ( digital , 191 patients ; traditional , 190 patients ) were well matched for baseline and surgical characteristics .
RESULTS	There were 325 lobectomies/bilobectomies and 56 segmentectomies , 308 of which were performed by video-assisted thoracic surgery ( VATS ) .
RESULTS	Patients randomized to digital systems had a significantly shorter air leak duration ( 1.0 versus 2.2 days ; p = 0.001 ) , duration of chest tube placement ( 3.6 versus 4.7 days ; p = 0.0001 ) , and postoperative length of stay ( 4.6 versus 5.6 days ; p < 0.0001 ) .
RESULTS	Subjective end points revealed a perceived improved ability to arise from bed ( p = 0.008 ) , system convenience for patients and personnel ( p = 0.02 ) , and the potential for being comfortable when discharged home with the device ( p = 0.06 ) .
RESULTS	A mean difference of 2.6 days from air leak cessation to tube removal was observed , which was similar in the 2 groups ( p = 0.7 ) .
RESULTS	Multivariable regression analysis showed that duration of chest tube placement after air leak cessation was directly associated with the amount of fluid drained during the first 48 hours ( p = 0.01 ) and the duration of air leak ( p = 0.008 ) , independent of hospital location .
CONCLUSIONS	Patients managed with digital drainage systems experienced a shorter duration of chest tube placement , shorter hospital stays , and higher satisfaction scores compared with those managed with traditional devices .
BACKGROUND	NCT01747889 . )

###24518937
OBJECTIVE	Pain after cesarean delivery is a leading cause of chronic pain and there are many attempts to reduce it without total success .
OBJECTIVE	Gabapentin is effective in reducing acute and chronic pain with little experience in parturient .
OBJECTIVE	The purpose of this study is to compare the effect of pre-emptive gabapentin with intrathecal fentanyl on reducing postoperative pain and morphine consumption in cesarean surgery .
METHODS	Seventy-eight primiparous women who scheduled for non-emergency cesarean delivery were enrolled in the study and separated into two groups .
METHODS	The control group received 12.5 mg of heavy bupivacaine 0.5 % plus 10 g of fentanyl intrathecally and the case group received 300 mg of gabapentin orally 2 h before surgery and 12.5 mg of heavy bupivacaine 0.5 % intrathecally .
METHODS	Data collection including blood pressure , heart rate , neonate sedation , Apgar score , visual analogous scale at several hours , at first , need to analgesic postoperatively .
RESULTS	In the fentanyl group , the need for analgesic drug was earlier , total dose of morphine in 24 h and patient satisfaction was higher than the gabapentin group .
RESULTS	The mean visual analogous scale at several hours postoperatively in the fentanyl groups was significantly higher than the gabapentin groups ( P = 0.001 ) .
CONCLUSIONS	Preemptive use of gabapentin is a safe and effective way to reduce postoperative pain and morphine consumption in parturients after cesarean surgery .

###24469137
OBJECTIVE	To evaluate the effect of dexmedetomidine on emergence agitation after oral and maxillofacial surgery .
METHODS	Fifty five patients who went into recovery room after oral and maxillofacial surgery were randomly divided into 2 groups : dexmedetomidine group ( n = 28 ) and control group ( n = 27 ) .
METHODS	Patients in dexmedetomidine group were assigned to receive intravenous dexmedetomidine at a dose of 0.3 g/kg when they came into recovery room .
METHODS	Patients in control group were assigned to receive intravenous normal saline .
METHODS	Emergence agitation was assessed and extubation time after operation was recorded .
METHODS	Mean arterial pressure , heart rate , arterial oxygen saturation , Ramsay scale were recorded at the time point of entering the recovery room instantly ( T0 ) and 5 minutes ( T1 ) , 15 minutes ( T2 ) , 30 minutes ( T3 ) , 60 minutes ( T4 ) , 120 minutes ( T5 ) after the patient came into recovery room .
METHODS	Statistical analysis was performed using SAS 9.1 software package .
RESULTS	The incidence of emergence agitation was significantly lower in the dexmedetomidine group ( 18 % ) than in the control group ( 70 % ) ( P < 0.05 ) .
RESULTS	The Ramsay scale was significantly higher in dexmedetomidine group than in the control group at the time point of T1 , T2 , T3 , T4 ( P < 0.05 ) .
RESULTS	The heart rate was significantly lower in dexmedetomidine group than in the control group at the time point of T1 , T2 , T3 , T4 , T5 ( P < 0.05 ) .
RESULTS	Mean arterial pressure was significantly lower in dexmedetomidine group than in the control group at the time point of T2 , T3 ( P < 0.05 ) .
RESULTS	There was no significant difference on extubation time between 2 groups .
RESULTS	There was no postoperative respiratory depression in 2 groups .
CONCLUSIONS	Intravenous dexmedetomidine at a dose of 0.3 g/kg can reduce emergence agitation after oral and maxillofacial surgery with safety and efficacy .

###24415390
OBJECTIVE	The objective was to describe parent-reported child eating behavior and maternal parenting impact outcomes of an infant feeding intervention to reduce child obesity risk .
METHODS	An assessor masked Randomized Controlled Trial ( RCT ) with concealed allocation of individual mother-infant dyads .
METHODS	The NOURISH RCT enrolled 698 first-time mothers ( mean age 30.1 years , SD = 5.3 ) with healthy term infants ( 51 % female ) aged 4.3 months ( SD = 1.0 ) at baseline .
METHODS	Outcomes were assessed 6 months post-intervention when the children were 2 years old .
METHODS	Mothers reported on child eating behaviors using the Children 's Eating Behavior Questionnaire ( CEBQ ) , food preferences , and dietary intake using a 24-hour telephone recall .
METHODS	Parenting was assessed using five scales validated for use in Australia .
RESULTS	Intervention effects were evident on the CEBQ overall ( MANOVA P = 0.002 ) and 4/8 subscales : child satiety responsiveness ( P = 0.03 ) , fussiness ( P = 0.01 ) , emotional overeating ( P < 0.01 ) , and food responsiveness ( P = 0.06 ) .
RESULTS	Intervention children `` liked '' more fruits ( P < 0.01 ) and fewer non-core foods and beverages ( P = 0.06 , 0.03 ) .
RESULTS	The intervention mothers reported greater `` autonomy encouragement '' ( P = 0.002 ) .
CONCLUSIONS	Anticipatory guidance on protective feeding practices appears to have modest positive impacts on child eating behaviors that are postulated to reduce future obesity risk .

###24490942
BACKGROUND	Metacognitive dysfunction has been widely recognized as a feature of schizophrenia .
BACKGROUND	As it is linked with deficits in several aspects of daily life functioning , improvement of metacognition may lead to improvement in functioning .
BACKGROUND	Individual psychotherapy might be a useful form of treatment to improve metacognition in patients with schizophrenia ; multiple case reports and a pilot study show promising results .
BACKGROUND	The present study aims to measure the effectiveness of an individual , manual-based therapy ( Metacognitive Reflection and Insight Therapy , MERIT ) in improving metacognition in patients with schizophrenia .
BACKGROUND	We also want to examine if improvement in metacognitive abilities is correlated with improvements in aspects of daily life functioning namely social functioning , experience of symptoms , quality of life , depression , work readiness , insight and experience of stigma .
METHODS	MERIT is currently evaluated in a multicenter randomized controlled trial .
METHODS	Thirteen therapists in six mental health institutions in the Netherlands participate in this study .
METHODS	Patients are randomly assigned to either MERIT or the control condition : treatment as usual ( TAU ) .
CONCLUSIONS	If proven effective , MERIT can be a useful addition to the care for schizophrenia patients .
CONCLUSIONS	The design brings along some methodological difficulties , these issues are addressed in the discussion of this paper .
BACKGROUND	Current Controlled Trials : ISRCTN16659871 .

###24861441
OBJECTIVE	Juvenile myoclonic epilepsy ( JME ) is a young-onset electroclinical syndrome , characterized by myoclonic , generalized tonic-clonic , and possibly typical absence seizures .
OBJECTIVE	Interictal electroencephalography ( EEG ) displays 3-6 Hz spike/polyspike and wave pattern .
OBJECTIVE	Photosensitivity is common .
OBJECTIVE	Our aim was to explore the blood oxygen level-dependent ( BOLD ) response evoked by a highly provocative photic stimulus in a cohort of people with JME compared to a group of nonphotosensitive healthy controls , and to investigate the hemodynamic phenomena seen in patients with photosensitive JME .
METHODS	We studied 13 JME patients and 18 healthy controls using EEG-functional magnetic resonance imaging ( fMRI ) performed during low luminance intermittent photic stimulation ( IPS ) .
METHODS	The BOLD response to IPS was investigated both in JME and control groups .
METHODS	In photosensitive JME subjects , we also performed a dynamic evaluation of BOLD signal changes evoked by the photoparoxysmal response ( PPR ) in a time frame ranging from 10 s before the onset of the EEG paroxysm up until 10 s afterward .
RESULTS	The IPS evoked a positive BOLD response in striate and extrastriate visual areas , which was less in JME patients than in controls .
RESULTS	Moreover , people with JME had a reduced positive BOLD response in the frontoparietal areas and putamen but a stronger negative BOLD response in the primary sensorimotor cortex ( SM1 ) and in cortical regions belonging to the default mode network ( DMN ) .
RESULTS	In JME , the dynamic evaluation of BOLD signal changes related to PPR revealed an early positive response in the putamen and SM1 , followed by BOLD signal decrements in the putamen , caudate nuclei , thalami , and SM1 .
CONCLUSIONS	Our results confirm the hypothesis that people with JME might have an altered interaction between the motor circuit and other neuronal networks , with prominent involvement of basal ganglia circuitry .
CONCLUSIONS	The PPR could be a final expression of pathogenic phenomena occurring in the striato-thalamocortical system , possibly a core feature of system epilepsy JME .

###26201510
OBJECTIVE	To assess the effectiveness of a two year exercise programme of progressive balance retraining in reducing injurious falls among women aged 75-85 at increased risk of falls and injuries and living in the community .
METHODS	Pragmatic multicentre , two arm , parallel group , randomised controlled trial .
METHODS	20 study sites in 16 medium to large cities throughout France .
METHODS	706 women aged 75-85 , living in their own home , and with diminished balance and gait capacities , randomly allocated to the experimental intervention group ( exercise programme , n = 352 ) or the control group ( no intervention , n = 354 ) .
METHODS	Weekly supervised group sessions of progressive balance training offered in community based premises for two years , supplemented by individually prescribed home exercises .
METHODS	A geriatrician blinded to group assignment classified falls into one of three categories ( no consequence , moderate , severe ) based on physical damage and medical care .
METHODS	The primary outcome was the rate of injurious falls ( moderate and severe ) .
METHODS	The two groups were compared for rates of injurious falls with a `` shared frailty '' model .
METHODS	Other outcomes included the rates of all falls , physical functional capacities ( balance and motor function test results ) , fear of falling ( FES-I ) , physical activity level , and perceived health related quality of life ( SF-36 ) .
METHODS	Analysis was by intention to treat .
RESULTS	There were 305 injurious falls in the intervention group and 397 in the control group ( hazard ratio 0.81 , 95 % confidence interval 0.67 to 0.99 ) .
RESULTS	The difference in severe injuries ( 68 in intervention group v 87 in control group ) was of the same order of magnitude ( 0.83 , 0.60 to 1.16 ) .
RESULTS	At two years , women in the intervention group performed significantly better on all physical tests and had significantly better perception of their overall physical function than women in the control group .
RESULTS	Among women who started the intervention ( n = 294 ) , the median number of group sessions attended was 53 ( interquartile range 16-71 ) .
RESULTS	Five injurious falls related to the intervention were recorded .
CONCLUSIONS	A two year progressive balance retraining programme combining weekly group and individual sessions was effective in reducing injurious falls and in improving measured and perceived physical function in women aged 75-85 at risk of falling.Trial registration ClinicalTrials.gov ( NCT00545350 ) .

###24472436
OBJECTIVE	We compared the efficacy of medical masks ( MM ) and N95 respirators ( N95 ) in preventing bacterial colonization/infection in healthcare workers ( HCWs ) .
METHODS	A cluster randomized clinical trial ( RCT ) of 1441 hospital HCWs randomized to medical masks or N95 respirators , and compared to 481 control HCWs , was performed in Beijing , China , during the winter season of 2008-2009 .
METHODS	Participants were followed for development of clinical respiratory illness ( CRI ) .
METHODS	Symptomatic subjects were tested for Streptococcus pneumoniae , Bordetella pertussis , Chlamydia pneumoniae , Mycoplasma pneumoniae or Haemophilus influenza type B by multiplex polymerase chain reaction ( PCR ) .
RESULTS	The rate of bacterial colonization was 2.8 % in the N95 group ( p = 0.02 ) , 5.3 % among medical mask users ( p < 0.01 ) and 7.5 % among the controls ( p = 0.16 ) .
RESULTS	N95 respirators were significantly protective ( adjusted RR 0.34 , 95 % CI : 0.21-0 .56 ) against bacterial colonization .
RESULTS	Co-infections of two bacteria or a virus and bacteria occurred in up to 3.7 % of HCWs , and were significantly lower in the N95 arm .
CONCLUSIONS	N95 respirators were significantly protective against bacterial colonization , co-colonization and viral-bacterial co-infection .
CONCLUSIONS	We showed that dual respiratory virus or bacterial-viral co-infections can be reduced by the use of N95 respirators .
CONCLUSIONS	This study has occupational health and safety implications for health workers .

###24618935
BACKGROUND	Fever and neutropenia ( FN ) often complicate anticancer treatment and can be caused by potentially fatal infections .
BACKGROUND	Knowledge of pathogen distribution is paramount for optimal patient management .
METHODS	Microbiologically defined infections ( MDI ) in pediatric cancer patients presenting with FN by nonmyeloablative chemotherapy enrolled in a prospective multicenter study were analyzed .
METHODS	Effectiveness of empiric antibiotic therapy in FN episodes with bacteremia was assessed taking into consideration recently published treatment guidelines for pediatric patients with FN .
RESULTS	MDI were identified in a minority ( 22 % ) of pediatric cancer patients with FN .
RESULTS	In patients with , compared with patients without MDI , fever [ median , 5 ( interquartile range : 3-8 ) vs. 2 ( interquartile range : 1-3 ) days , P < 0.001 ] and hospitalization [ 10 ( 6-14 ) vs. 5 ( 3-8 ) days , P < 0.001 ] lasted longer , transfer to the intensive care unit was more likely [ 13 of 95 ( 14 % ) vs. 7 of 346 ( 2.0 % ) , P < 0.001 ] , and antibiotics were given longer [ 10 ( 7-14 ) vs. 5 ( 4-7 ) days , P < 0.001 ] .
RESULTS	Empiric antibiotic therapy in FN episodes with bacteremia was highly effective if not only intrinsic and reported antimicrobial susceptibilities were considered but also the purposeful omission of coverage for coagulase-negative staphylococci and enterococci was taken into account [ 81 % ( 95 % confidence interval : 68-90 ) vs. 96.6 % ( 95 % confidence interval : 87-99 .4 ) , P = 0.004 ] .
CONCLUSIONS	MDI were identified in a minority of FN episodes but they significantly affected management and the clinical course of pediatric cancer patients .
CONCLUSIONS	Compliance with published guidelines was associated with effectiveness of empiric antibiotic therapy in FN episodes with bacteremia .

###25146586
BACKGROUND	The efficacy and safety of certolizumab pegol ( CZP ) in moderate-to-severe Crohn 's disease were demonstrated in two 26-week double-blind studies ( PRECiSE 1 & 2 ) .
OBJECTIVE	To report the safety and efficacy outcomes of long-term , CZP therapy from PRECiSE 3 , in which patients received treatment up to 7years treatment .
METHODS	Patients completing PRECiSE 1 or 2 were eligible to enter PRECiSE 3 in which they received CZP 400mg , open-label , every 4weeks ( without additional induction therapy ) for up to 7years , for up to 91 doses from study start .
METHODS	Safety ( adverse events , including infections and malignancies ) and efficacy ( Harvey-Bradshaw Index , faecal calprotectin , C-reactive protein ) were prospectively monitored .
METHODS	Remission was analysed using observed cases , last observation carried forward imputation and nonresponder imputation .
RESULTS	A total of 595 patients entered the study ; 117 ( 20 % ) completed 7years .
RESULTS	Discontinuation rates were 29.2 % , 13.6 % , 16.1 % , 7.9 % , 5.0 % , 4.5 % and 3.9 % ( years 1-7 respectively ) .
RESULTS	During 1920 patient-years of exposure to CZP , no new safety signals were observed .
RESULTS	Incidence rates ( new cases/100 patient-years ) for serious infections and malignant neoplasms were 4.37 and 1.06 respectively .
RESULTS	No lymphoproliferative malignancies were reported .
RESULTS	Clinical remission rates were 68 % at each year ( observed cases ) ; rates by last observation carried forward and nonresponder imputation were 58 % and 45 % at year 1 , 56 % and 26 % at year 3 and 55 % and 13 % at year 7 respectively .
CONCLUSIONS	Certolizumab pegol was well tolerated in the long-term treatment of Crohn 's disease , with sustained remission in some patients continuing in the study for up to 7years .
CONCLUSIONS	ClinicalTrials.gov identifier NCT00552058 .

###24805184
BACKGROUND	HIV-1 plasma viral load during treatment can be highly variable .
BACKGROUND	Thus , there is the need to find a measure of cumulative viremia that can be used to assess both the short - and long-term efficacy of highly active antiretroviral therapy ( HAART ) .
BACKGROUND	Here , we validate a measure of cumulative viremia to evaluate HAART efficacy .
METHODS	We accessed HAART efficacy using data from a randomized clinical trial conducted in Mexico .
METHODS	We compared the proportion of individuals achieving a viral load < 50 and < 400 copies/mL at week 48 , against the cumulative plasma viral load , estimated as the area under the plasma viral load curve ( AUVLC ) .
METHODS	High AUVLC indicates high cumulative viremia .
CONCLUSIONS	There was a strong and significant association between the proportion of individuals achieving a viral load < 50 and < 400 copies/mL at week 48 , with individuals suppressed having significant lower cumulative viremia .
CONCLUSIONS	The median area was 7513 ( 25th-75th percentile [ Q1-Q3 ] 6634-8180 ) if viral load < 50 copies/mL and 7679 ( Q1-Q3 6899-9373 ) if viral load 50 copies/mL ( p-value 0.0284 ) .
CONCLUSIONS	When the analysis was stratified by study arm , individuals on efavirenz had lower cumulative viremia than those on boosted lopinavir .
CONCLUSIONS	Our findings suggest that cumulative viremia should be explored further as a tool to simultaneously evaluate the individual and public health efficacy of HAART .
CONCLUSIONS	This is particularly relevant to the implementation and evaluation of the Treatment 2.0 strategy recently proposed by UNAIDS and the WHO , as a means to maximize the individual and public health benefit of HAART .

###25230071
OBJECTIVE	To determine whether differences could be detected in mobility outcomes during community mobility and home mobility tasks according to type of mobility assistive device .
METHODS	Randomized , repeated measures .
METHODS	Community mobility task : traversing 341.4 m between the rehabilitation clinic and hospital entrance ; home mobility task : traversing 39m into and out of a patient training bathroom and bedroom .
METHODS	Community-dwelling , cognitively intact ambulatory veterans ( N = 59 ) who used a mobility device within the 14 days prior to the study .
METHODS	Participants tested 3 types of mobility assistive devices with wheels : 4-wheeled walker ( WW ) , manual wheelchair ( MWC ) , and powered wheelchair ( PWC ) .
METHODS	The first and last devices used by each participant were randomly assigned as either MWC or WW .
METHODS	The PWC was always the second device .
METHODS	Speed ( m/s ) , collisions ( total ) , fatigue ( 0-10 Likert scale ) , and pain ( 0-10 Likert scale , diagram ) .
RESULTS	The community mobility task was performed with all 3 devices by 52 ( 88 % ) veterans , and the home mobility task was performed with all 3 devices by 53 ( 90 % ) participants .
RESULTS	In each task , 28 participants used the WW and 28 participants used the MWC as the final device .
RESULTS	In the community mobility task , statistically significant differences ( P < .05 ) were seen with 1 device comparison for all studied outcomes ( eg , standardized mean difference for the MWC compared with the PWC showed -.67 fewer collisions for the MWC ) .
RESULTS	In the home mobility task , speed , collisions , and fatigue showed statistically significant ( P < .05 ) device-related differences ( eg , standardized mean difference for the WW compared with the MWC showed -.88 fewer collisions for the WW ) .
CONCLUSIONS	We found statistically significant and substantively different effects from 3 commonly used mobility assistive devices with wheels on diverse mobility outcomes when used in typical community mobility and home mobility tasks , providing proof of concept support for a research methodology applicable to comparative outcome studies of diverse mobility aids .

###24707675
BACKGROUND	Ramadan fasting is a special model of hunger and particularly affects metabolic processes , including carbohydrate and lipid levels .
BACKGROUND	Endocrine changes induced by Ramadan fasting are not well known .
OBJECTIVE	The aim of this article was to evaluate the changes in hormone levels in women before and after the special Muslim fasting period of Ramadan .
METHODS	This study was performed in 30 healthy women in Obstetrics and Gynecology department during the Ramadan month of2011 .
METHODS	Patients during and after the first menstrual period had menstrual cycles fasting blood samples taken on the same days .
METHODS	Luteinizing hormone ( LH ) , follicle stimulating hormone ( FSH ) , estradiol ( E2 ) , testosterone , and prolactin ( PRL ) levels were determined .
RESULTS	Before and during fasting LH , FSH , E2 , testosterone and PRL levels were not statistically different .
CONCLUSIONS	Despite the limited available studies on these subjects in women , effect of Ramadan fasting on hormone levels were found to be within the normal limits .

###25487932
OBJECTIVE	This work intended to observe the effect of injecting botolinum toxin type A ( BTX-A ) for relieving spastic iliopsoas of cerebral palsy on children , and to investigate the improvement of this method for the motor function in these children .
METHODS	From July 2006 to August 2012 , 37 children with spastic iliopsoas cerebral palsy were received rehabilitation therapy .
METHODS	The age ranged from 3 to 15 years .
METHODS	The control group were treated by conventional physical therapy ( PY ) .
METHODS	The experimental group were treated not only by the conventional physical therapy , but also BTX-A injection .
METHODS	The dose of BTX-A injection was according to the weight of the child and the Modified Ashworth Scale ( MAS ) .
METHODS	The dose of the injection ranged from 15 IU to 45 IU with the average dose 31.213.9 IU .
RESULTS	There was no significant difference between two the groups on ages , weight and MAS , GMFM ( Gross Motor Function Measure ) and extension angle of hip joints before treatment .
RESULTS	In both groups , the Modified Ashworth Scale decreased , GMFM and extension angle of hip joints increased after eight weeks .
RESULTS	In the control group , the GMFM improved significantly .
RESULTS	In the experimental group , MAS , GMFM and extension angle of hip joints changed significantly after therapy .
RESULTS	There was significant difference between two groups in MAS , GMFM and extension angle of hip joints after two months .
CONCLUSIONS	The BTX-A injection can relieve iliopsoas spasticity of cerebral palsy on children efficiently .
CONCLUSIONS	This therapy can help children to correct abnormal gait and to improve their motor function .

###24954573
OBJECTIVE	This study sought to assess radiation exposure and operator discomfort when using left radial approach ( LRA ) versus right radial approach ( RRA ) for coronary diagnostic and percutaneous interventions .
BACKGROUND	The transradial approach is increasingly being adopted as the preferred vascular access for coronary interventions .
BACKGROUND	Currently , most are performed using an RRA .
BACKGROUND	This is in part due to the perceived increased operator physical discomforts as well increased radiation exposure with an LRA .
METHODS	One hundred patients were randomized to an LRA or RRA .
METHODS	Each operator ( n = 5 ) had an independent randomization process , and patients were stratified according to obesity status .
METHODS	Operator radiation was measured using separate sets of radiation dosimeter badges placed externally on the head and thyroid and internally on the sternum .
METHODS	Operator physical discomfort was surveyed at 2 time points : during vascular access and at the end of the procedure .
METHODS	Moderate to severe physical discomfort was defined as a score of > 4 .
RESULTS	There were no significant differences in baseline and procedural variables between groups .
RESULTS	There was a significant increase in external radiation exposure using the RRA versus LRA ( head : median : 6.12 [ interquartile range ( IQR ) : 2.6 to 16.6 ] mRems vs. median : 12.0 [ IQR : 6.4 to 22.0 ] mRems , p = 0.02 ; thyroid : median : 10.10 [ IQR : 4.3 to 25 ] mRems vs. median : 18.70 [ IQR : 11.0 to 38 ] mRems , p = 0.001 ) .
RESULTS	More discomfort was reported with the LRA during access ( LRA : 22 % vs. RRA : 4 % ; p = 0.017 ) , but not during the procedure ( LRA : 10.0 % vs. RRA : 4.0 % , p = 0.43 ) .
RESULTS	This difference was almost entirely noted inobese patients ( LRA : 30.0 % vs. RRA : 3.7 % , p = 0.005 ) .
CONCLUSIONS	LRA is as effective as RRA , showing a safer profile with decreased radiation exposure to the operator , at the expense of more operator discomfort only during vascular access and limited to obese patients .

###24712568
OBJECTIVE	To determine dose-dependent effects of T administration on cardiovascular risk markers in women with low T levels .
METHODS	Seventy-one hysterectomized women with or without oophorectomy with total T < 31 ng/dL and/or free T < 3.5 pg/mL received a standardized transdermal estradiol regimen during the 12-week run-in period and were then randomized to receive weekly im injections of placebo or 3 - , 6.25 - , 12.5 - , or 25-mg T enanthate for 24 weeks .
METHODS	Total and free T levels were measured by liquid chromatography-tandem mass spectrometry and equilibrium dialysis , respectively .
METHODS	Insulin resistance and inflammatory markers were measured at baseline and 24 weeks .
METHODS	In a subset of women , magnetic resonance imaging of the abdomen was performed to quantify abdominal fat volume .
RESULTS	Fifty-nine women who completed the 24-week intervention were included in the final analysis .
RESULTS	The five groups were similar at baseline .
RESULTS	Mean on-treatment nadir total T concentrations were 14 , 79 , 105 , 130 , and 232 ng/dL in the placebo group and the 3 - , 6.25 - , 12.5 - , and 25-mg groups , respectively .
RESULTS	No significant changes in fasting glucose , fasting insulin , homeostatic model assessment of insulin resistance , high sensitivity C-reactive protein , adiponectin , blood pressure , and heart rate were observed at any T dose when compared to placebo .
RESULTS	Similarly , no dose - or concentration-dependent changes were observed in abdominal fat on magnetic resonance imaging .
CONCLUSIONS	Short-term T administration over a wide range of doses for 24 weeks in women with low T levels was not associated with worsening of cardiovascular risk markers .

###24973281
BACKGROUND	The phe508del CFTR mutation causes cystic fibrosis by limiting the amount of CFTR protein that reaches the epithelial cell surface .
BACKGROUND	We tested combination treatment with lumacaftor , an investigational CFTR corrector that increases trafficking of phe508del CFTR to the cell surface , and ivacaftor , a CFTR potentiator that enhances chloride transport of CFTR on the cell surface .
METHODS	In this phase 2 clinical trial , we assessed three successive cohorts , with the results of each cohort informing dose selection for the subsequent cohort .
METHODS	We recruited patients from 24 cystic fibrosis centres in Australia , Belgium , Germany , New Zealand , and the USA .
METHODS	Eligibility criteria were : confirmed diagnosis of cystic fibrosis , age at least 18 years , and a forced expiratory volume in 1 s ( FEV1 ) of 40 % or more than predicted .
METHODS	Cohort 1 included phe508del CFTR homozygous patients randomly assigned to either lumacaftor 200 mg once per day for 14 days followed by addition of ivacaftor 150 mg or 250 mg every 12 h for 7 days , or 21 days of placebo .
METHODS	Together , cohorts 2 and 3 included phe508del CFTR homozygous and heterozygous patients , randomly assigned to either 56 days of lumacaftor ( cohort 2 : 200 mg , 400 mg , or 600 mg once per day , cohort 3 : 400 mg every 12 h ) with ivacaftor 250 mg every 12 h added after 28 days , or 56 days of placebo .
METHODS	The primary outcomes for all cohorts were change in sweat chloride concentration during the combination treatment period in the intention-to-treat population and safety ( laboratory measurements and adverse events ) .
METHODS	The study is registered with ClinicalTrials.gov , number NCT01225211 , and EudraCT , number 2010-020413-90 .
RESULTS	Cohort 1 included 64 participants .
RESULTS	Cohort 2 and 3 combined contained 96 phe508del CFTR homozygous patients and 28 compound heterozygotes .
RESULTS	Treatment with lumacaftor 200 mg once daily and ivacaftor 250 mg every 12 h decreased mean sweat chloride concentration by 9.1 mmol/L ( p < 0.001 ) during the combination treatment period in cohort 1 .
RESULTS	In cohorts 2 and 3 , mean sweat chloride concentration did not decrease significantly during combination treatment in any group .
RESULTS	Frequency and nature of adverse events were much the same in the treatment and placebo groups during the combination treatment period ; the most commonly reported events were respiratory .
RESULTS	12 of 97 participants had chest tightness or dyspnoea during treatment with lumacaftor alone .
RESULTS	In pre-planned secondary analyses , a significant decrease in sweat chloride concentration occurred in the treatment groups between day 1 and day 56 ( lumacaftor 400 mg once per day group -9.1 mmol/L , p < 0.001 ; lumacaftor 600 mg once per day group -8.9 mmol/L , p < 0.001 ; lumacaftor 400 mg every 12 h group -10.3 mmol/L , p = 0.002 ) .
RESULTS	These changes were significantly greater than the change in the placebo group .
RESULTS	In cohort 2 , the lumacaftor 600 mg once per day significantly improved FEV1 from day 1 to 56 ( difference compared with placebo group : +5.6 percentage points , p = 0.013 ) , primarily during the combination period .
RESULTS	In cohort 3 , FEV1 did not change significantly across the entire study period compared with placebo ( difference +4.2 percentage points , p = 0.132 ) , but did during the combination period ( difference +7.7 percentage points , p = 0003 ) .
RESULTS	Phe508del CFTR heterozygous patients did not have a significant improvement in FEV1 .
CONCLUSIONS	We provide evidence that combination lumacaftor and ivacaftor improves FEV1 for patients with cystic fibrosis who are homozygous for phe508del CFTR , with a modest effect on sweat chloride concentration .
CONCLUSIONS	These results support the further exploration of combination lumacaftor and ivacaftor as a treatment in this setting .
BACKGROUND	Vertex Pharmaceuticals , Cystic Fibrosis Foundation Therapeutics Development Network .

###24736628
OBJECTIVE	The aim of this study was to assess the glucose-lowering and lipid-modifying effects , and safety profile of lobeglitazone , a novel peroxisome proliferator-activated receptor - agonist , compared to placebo as a monotherapy in patients with type 2 diabetes .
METHODS	In this 24-week , multicenter , randomized , double-blind , parallel-group , placebo controlled study , 173 patients were randomly assigned ( a 21 ratio ) to lobeglitazone 0.5 mg ( n = 115 ) or matching placebo ( n = 58 ) orally once daily .
METHODS	The primary endpoint was the change in glycated hemoglobin ( HbA1c ) from baseline to the end of treatment .
METHODS	The secondary endpoints included various glycemic parameters , lipid parameters and safety profile ( ClinicalTrials.gov number NCT01001611 ) .
RESULTS	At 24 weeks , a significant reduction in HbA1c was observed with lobeglitazone versus placebo ( -0.44 % vs 0.16 % , mean difference -0.6 % , p < 0.0001 ) .
RESULTS	The goal of HbA1c < 7 % was achieved significantly more in the lobeglitazone group compared to the placebo group ( 44 % vs 12 % , p < 0.0001 ) .
RESULTS	Markers of insulin resistance were also improved in the lobeglitazone group .
RESULTS	In addition , lobeglitazone treatment significantly improved triglycerides , high density lipoprotein cholesterol , small dense low density lipoprotein cholesterol , free fatty acid , and apolipoprotein-B/CIII compared to placebo ( p < 0.01 , respectively ) .
RESULTS	More weight gain was observed in the lobeglitazone group than the placebo group ( 0.89 kg vs - 0.63 kg , mean difference 1.52 kg , p < 0.0001 ) .
RESULTS	The safety profile was comparable between the two groups and lobeglitazone was well tolerated .
CONCLUSIONS	Lobeglitazone 0.5 mg showed a favorable balance in the efficacy and safety profile .
CONCLUSIONS	The results support a potential role of lobeglitazone in treating type 2 diabetes .
BACKGROUND	Clinicaltrials.gov NCT01001611 .

###25919263
BACKGROUND	Pulsed electromagnetic fields have been shown to reduce postoperative pain , inflammation , and narcotic requirements after breast reduction and augmentation surgical procedures .
BACKGROUND	This study examined whether pulsed electromagnetic field therapy could produce similar results in patients undergoing unilateral transverse rectus abdominis myocutaneous ( TRAM ) flap breast reconstruction , a significantly more complex and painful surgical procedure .
METHODS	In this double-blind , placebo-controlled , randomized study , 32 patients undergoing unilateral TRAM flap breast reconstruction received active or sham pulsed electromagnetic field therapy .
METHODS	Pain levels were measured by using a visual analogue scale ; narcotic use and wound exudate volume were recorded starting 1 hour postoperatively .
METHODS	Wound exudates were analyzed for interleukin-1 .
RESULTS	Mean visual analogue scale pain scores were 2-fold higher in the sham cohort at 5 hours and 4-fold higher at 72 hours ( p < 0.01 ) , along with a concomitant 2-fold increase in narcotic use in sham patients ( p < 0.01 ) .
RESULTS	Wound exudate volume was 2-fold higher in the sham cohort at 24 hours ( p < 0.01 ) , and mean interleukin-1 concentration in wound exudates of sham patients was 5-fold higher at 24 hours ( p < 0.001 ) .
CONCLUSIONS	Pulsed electromagnetic field therapy significantly reduced postoperative pain , inflammation , and narcotic use following TRAM flap breast reconstruction , paralleling its effect in breast reduction patients .
CONCLUSIONS	Both studies also report a significant reduction of interleukin-1 in the wound exudate , supporting a mechanism involving a pulsed electromagnetic field effect on nitric oxide/cyclic guanosine monophosphate signaling , which modulates the body 's antiinflammatory pathways .
CONCLUSIONS	Adjunctive pulsed electromagnetic field therapy could impact the speed and quality of wound repair in many surgical procedures .
METHODS	Therapeutic , I.

###25160013
OBJECTIVE	The objective of this study was to investigate the hypouricemic effects of green tea extract ( GTE ) in healthy individuals .
METHODS	This study comprised 1-week control , 2-week interventional , and 1-week follow-up periods .
METHODS	Participants were assigned randomly at the interventional period to consume GTE at 2 ( GTE2 ) , 4 ( GTE4 ) , or 6 ( GTE6 ) g/d .
METHODS	Levels of serum uric acid ( SUA ) , uric acid clearance , and serum antioxidant power ( using trolox equivalent antioxidant capacity assay ) were measured at both ends of each study period .
RESULTS	Of 30 participants , 11 , 11 , and 8 received GTE2 , GTE4 , and GTE6 , respectively .
RESULTS	After 2 weeks of consumption , the mean SUA level tended to decrease in all groups , with no statistical significance .
RESULTS	Serum uric acid reduction was greatest in GTE2 ( from 4.81 0.81 mg/dL to 4.64 0.92 mg/dL , 3.53 % ) .
RESULTS	Uric acid clearance decreased significantly in GTE2 ( from 11.37 6.41 mL/min per 1.73 m to 7.44 2.74 mL/min per 1.73 m , 34.56 % , P < 0.05 ) and GTE4 ( from 8.36 3.41 mL/min per 1.73 m to 5.78 2.33 mL/min per 1.73 m , 30.86 % , P < 0.05 ) .
RESULTS	Serum antioxidant capacity ( TEAC ) increased significantly in GTE6 ( from 32.77 3.39 mg/mL to 35.41 3.17 mg/mL , 8.06 % , P < 0.05 ) .
RESULTS	There was no significant change in creatinine clearance .
RESULTS	Gastrointestinal adverse events were common , but usually mild , with no medical treatment required .
CONCLUSIONS	Green tea extract may modestly lower SUA level and decreases uric acid clearance .
CONCLUSIONS	Green tea extract also significantly elevated serum antioxidant capacity with a positive dosage effect .
CONCLUSIONS	The effect of GTE on SUA in healthy individuals was short term .
CONCLUSIONS	The effects of GTE on urate handling in patients with hyperuricemia or gout need to be determined .

###25613721
BACKGROUND	An intradermal ( ID ) trivalent split-virion influenza vaccine ( IIV3-ID ) ( Fluzone ( ) Intradermal , Sanofi Pasteur , Swiftwater , PA ) has been available in the US since the 2011/2012 influenza season for adults aged 18-64 years .
BACKGROUND	This study examined whether adding a second B-lineage strain affects immunogenicity and safety .
METHODS	This randomized , double-blind , multicentre trial evaluated the immunogenicity and safety of an intradermal quadrivalent split-virion influenza vaccine ( IIV4-ID ) in adults 18-64 years of age in the US during the 2012-2013 influenza season .
METHODS	Participants were randomized 2:1:1 to receive a single injection of IIV4-ID , licensed IIV3-ID , or an investigational IIV3-ID containing the alternate B-lineage strain .
METHODS	Haemagglutination inhibition antibody titres were assessed in two-thirds of participants before vaccination and 28 days after vaccination .
RESULTS	1672 participants were vaccinated with IIV4-ID , 837 with licensed IIV3-ID , and 846 with an investigational IIV3-ID .
RESULTS	For all four vaccine strains , antibody responses to IIV4-ID were statistically non-inferior to the response to the IIV3-ID vaccines containing the matched strains .
RESULTS	For both B strains , post-vaccination antibody responses to IIV4-ID were statistically superior to the responses to IIV3-ID lacking the corresponding B strain .
RESULTS	Adverse events were similar for IIV4-ID and IIV3-ID .
RESULTS	The most commonly reported solicited reactions were pain , pruritus , myalgia , headache , and malaise ; and most were grade 1 or 2 and appeared and resolved within 3 days of vaccination .
RESULTS	IIV4-ID was statistically non-inferior to the two pooled IIV3-ID vaccines for the proportions of participants with at least one grade 2 or 3 systemic reaction .
CONCLUSIONS	Antibody responses to the IIV4-ID were non-inferior to IIV3-ID for the A and matched B strains and superior for the unmatched B strains .
CONCLUSIONS	IIV4-ID was well tolerated without any safety concerns .
CONCLUSIONS	IIV4-ID may help address an unmet need due to mismatched B strains in previous influenza vaccines .

###25270275
BACKGROUND	Blood transfusions are frequently given to patients with septic shock .
BACKGROUND	However , the benefits and harms of different hemoglobin thresholds for transfusion have not been established .
METHODS	In this multicenter , parallel-group trial , we randomly assigned patients in the intensive care unit ( ICU ) who had septic shock and a hemoglobin concentration of 9 g per deciliter or less to receive 1 unit of leukoreduced red cells when the hemoglobin level was 7 g per deciliter or less ( lower threshold ) or when the level was 9 g per deciliter or less ( higher threshold ) during the ICU stay .
METHODS	The primary outcome measure was death by 90 days after randomization .
RESULTS	We analyzed data from 998 of 1005 patients ( 99.3 % ) who underwent randomization .
RESULTS	The two intervention groups had similar baseline characteristics .
RESULTS	In the ICU , the lower-threshold group received a median of 1 unit of blood ( interquartile range , 0 to 3 ) and the higher-threshold group received a median of 4 units ( interquartile range , 2 to 7 ) .
RESULTS	At 90 days after randomization , 216 of 502 patients ( 43.0 % ) assigned to the lower-threshold group , as compared with 223 of 496 ( 45.0 % ) assigned to the higher-threshold group , had died ( relative risk , 0.94 ; 95 % confidence interval , 0.78 to 1.09 ; P = 0.44 ) .
RESULTS	The results were similar in analyses adjusted for risk factors at baseline and in analyses of the per-protocol populations .
RESULTS	The numbers of patients who had ischemic events , who had severe adverse reactions , and who required life support were similar in the two intervention groups .
CONCLUSIONS	Among patients with septic shock , mortality at 90 days and rates of ischemic events and use of life support were similar among those assigned to blood transfusion at a higher hemoglobin threshold and those assigned to blood transfusion at a lower threshold ; the latter group received fewer transfusions .
CONCLUSIONS	( Funded by the Danish Strategic Research Council and others ; TRISS ClinicalTrials.gov number , NCT01485315 . )

###26022813
BACKGROUND	Most patients with acute coronary syndrome ( ACS ) are treated with statins , which reduce atherogenic triglyceride-rich lipoproteins .
BACKGROUND	It is uncertain whether triglycerides predict risk after ACS on a background of statin treatment .
OBJECTIVE	This study examined the relationship of fasting triglyceride levels to outcomes after ACS in patients treated with statins .
METHODS	Long-term and short-term relationships of triglycerides to risk after ACS were examined in the dal-OUTCOMES trial and atorvastatin arm of the MIRACL ( Myocardial Ischemia Reduction with Acute Cholesterol Lowering ) trial , respectively .
METHODS	Analysis of dal-OUTCOMES included 15,817 patients ( 97 % statin-treated ) randomly assigned 4 to 12 weeks after ACS to treatment with dalcetrapib ( a cholesteryl ester transfer protein inhibitor ) or placebo and followed for a median 31 months .
METHODS	Analysis of MIRACL included 1,501 patients treated with atorvastatin 80 mg daily beginning 1 to 4 days after ACS and followed for 16 weeks .
METHODS	Fasting triglycerides at initial random assignment were related to risk of coronary heart disease death , nonfatal myocardial infarction , stroke , and unstable angina in models adjusted for age , sex , hypertension , smoking , diabetes , high-density lipoprotein cholesterol , and body mass index .
RESULTS	Fasting triglyceride levels were associated with both long-term and short-term risk after ACS .
RESULTS	In dal-OUTCOMES , long-term risk increased across quintiles of baseline triglycerides ( p < 0.001 ) .
RESULTS	The hazard ratio in the highest/lowest quintile ( > 175/80 mg/dl ) was 1.61 ( 95 % confidence interval : 1.34 to 1.94 ) .
RESULTS	There was no interaction of triglycerides and treatment assignment on the primary outcome .
RESULTS	In the atorvastatin group of MIRACL , short-term risk increased across tertiles of baseline triglycerides ( p = 0.03 ) , with a hazard ratio of 1.50 [ corrected ] ( 95 % confidence interval : 1.05 to 2.15 ) in highest/lowest tertiles ( > 195/135 mg/dl ) .
RESULTS	The relationship of triglycerides to risk was independent of low-density lipoprotein cholesterol in both studies .
CONCLUSIONS	Among patients with ACS treated effectively with statins , fasting triglycerides predict long-term and short-term cardiovascular risk .
CONCLUSIONS	Triglyceride-rich lipoproteins may be an important additional target for therapy .
CONCLUSIONS	( A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome ; NCT00658515 ) .

###25467560
BACKGROUND	Both hepatitis C virus ( HCV ) mono-infected and HIV/HCV co-infected patients are in need of safe , effective , all-oral HCV regimens .
BACKGROUND	In a phase 2 study we aimed to assess the efficacy and safety of grazoprevir ( MK-5172 ; HCV NS3/4A protease inhibitor ) and two doses of elbasvir ( MK-8742 ; HCV NS5A inhibitor ) in patients with HCV mono-infection and HIV/HCV co-infection .
METHODS	The C-WORTHY study is a phase 2 , multicentre , randomised controlled trial of grazoprevir plus elbasvir with or without ribavirin in patients with HCV ; here , we report findings for previously untreated ( genotype 1 ) patients without cirrhosis who were HCV mono-infected or HIV/HCV co-infected .
METHODS	Eligible patients were previously untreated adults aged 18 years or older with chronic HCV genoype 1 infection and HCV RNA at least 10000 IU/mL in peripheral blood without evidence of cirrhosis , hepatocellular carcinoma , or decompensated liver disease .
METHODS	In part A of the study we randomly assigned HCV-mono-infected patients to receive 12 weeks of grazoprevir ( 100 mg ) plus elbasvir ( 20 mg or 50 mg ) with or without ribavirin ( arms A1-3 ) ; in part B we assigned HCV-mono-infected patients to 8 or 12 weeks of grazoprevir ( 100 mg ) plus elbasvir ( 50 mg ) with or without ribavirin ( arms B1-3 ) and HIV/HCV co-infected patients to 12 weeks of therapy with or without ribavirin .
METHODS	The primary endpoint was the proportion of patients achieving HCV RNA less than 25 IU/mL 12 weeks after end of treatment ( SVR12 ) .
METHODS	Randomisation was by presence or absence of ribavirin , 8 or 12 weeks of treatment , and dosage of elbasvir .
METHODS	Patients were stratified by gentoype 1a versus 1b .
METHODS	The patients , investigators , and study site personnel were masked to treatment group assignements but the funder was not .
METHODS	Analysis was by intention to treat .
METHODS	This trial is registered at ClinicalTrials.gov , number NCT01717326 .
RESULTS	218 patients with HCV mono-infection ( n = 159 ) and HIV/HCV co-infection ( n = 59 ) were enrolled .
RESULTS	SVR12 for patients treated for 12 weeks with or without ribavirin ranged from 93-98 % in mono-infected and 87-97 % in co-infected patients .
RESULTS	SVR12 rates in mono-infected and co-infected patients treated for 12 weeks without ribavirin were 98 % ( 95 % CI 88-100 ; 43/44 ) and 87 % ( 95 % CI 69-96 ; 26/30 ) , respectively , and with ribavirin were 93 % ( 95 % CI 85-97 ; 79/85 ) and 97 % ( 95 % CI 82-100 ; 28/29 ) , respectively .
RESULTS	Among mono-infected patients with genotype 1a infection treated for 8 weeks , SVR12 was 80 % ( 95 % CI 61-92 ; 24/30 ) .
RESULTS	Five of six patients who discontinued early for reasons other than virological failure had HCV RNA less than 25 IU/mL at their last study visit .
RESULTS	Virological failure among patients treated for 12 weeks occurred in seven patients ( 7/188 , 4 % ) and was associated with emergence of resistance-associated variants to one or both drugs .
RESULTS	The safety profile of grazoprevir plus elbasvir with or without ribavirin was similar in mono-infected and co-infected patients .
RESULTS	No patient discontinued due to an adverse event or laboratory abnormality .
RESULTS	The most common adverse events were fatigue ( 51 patients , 23 % ) , headache ( 44 , 20 % ) , nausea ( 32 , 15 % ) , and diarrhoea ( 21 , 10 % ) .
CONCLUSIONS	Once-daily grazoprevir plus elbasvir with or without ribavirin for 12 weeks in previously untreated HCV-mono-infected and HIV/HCV-co-infected patients without cirrhosis achieved SVR12 rates of 87-98 % .
CONCLUSIONS	These results support the ongoing phase 3 development of grazoprevir plus elbasvir .
BACKGROUND	Merck & Co , Inc. .

###24371021
BACKGROUND	Treatment options for adults with attention deficit hyperactivity disorder ( ADHD ) are limited .
BACKGROUND	The study was conducted to confirm the clinically effective and safe dose of methylphenidate hydrochloride modified-release ( MPH-LA ) in adults with ADHD and evaluate the maintenance of effect of MPH-LA .
METHODS	The study consisted of three treatment phases .
METHODS	The double-blind dose-confirmation phase : 9-week double-blind period ( 3-week titration period , 6-week fixed dose ) with randomization to MPH-LA 40 , 60 , or 80mg/day or placebo .
METHODS	The real-life dose-optimization phase : a 5-week re-titration period to optimal dose ; and the double-blind maintenance of effect phase , a 6-month double-blind randomized placebo-controlled maintenance of effect phase .
METHODS	The three co-primary endpoints were change in Diagnostic and Statistical Manual of Mental Disorders-IV ADHD Rating Scale ( DSM-IV ADHD RS ) and Sheehan Disability Scale ( SDS ) total scores from baseline to end of 9-week confirmation phase and the percentage of treatment failures during the 6-month maintenance of effect phase .
RESULTS	725 of 863 screened patients were randomized to 40 ( N = 181 ) , 60 ( N = 182 ) , or 80mg ( N = 181 ) MPH-LA or placebo ( N = 181 ) , and 584 ( 80.6 % ) completed .
RESULTS	489 ( 83.7 % ) of completers were re-randomized to the double-blinded maintenance of effect phase and 235 ( 48.1 % ) of them completed .
RESULTS	Improvement from baseline in DSM-IV ADHD RS ( P < 0.0001 for all comparisons ) and SDS ( 40mg , P = 0.0003 ; 60mg , P = 0.0176 ; 80mg , P < 0.0001 ) total scores was significantly greater vs. placebo for all MPH-LA doses .
RESULTS	Treatment failure rate was significantly lower with MPH-LA ( 21.3 % ) versus placebo ( 49.6 % ) during the 6-month maintenance of effect phase .
RESULTS	Safety profile was consistent with the profile for MPH-LA in children ; percentage of serious adverse events was comparable between all MPH-LA arms ( 1.3 % ) and placebo ( 1.5 % ) , while percentage of adverse events was higher in MPH-LA arms .
CONCLUSIONS	MPH-LA provided and maintained significant symptomatic and functional improvement in adult ADHD patients .

###24347765
OBJECTIVE	To compare the effect of melatonin and gabapentin on anxiety , pain , sedation scores , and satisfaction of surgeon in patients of cataract surgery .
METHODS	One hundred thirty patients aged between 35 and 85 years scheduled for cataract surgery were randomly allocated to three study groups to receive melatonin ( 6 mg ) , gabapentin ( 600 mg ) or placebo 90 min before arrival in the operating room .
METHODS	Pain , anxiety , and sedation scores during block and surgery as well as the surgeon 's satisfaction with the surgery were assessed .
RESULTS	Anxiety scores decreased significantly in melatonin and gabapentin groups compared to the placebo group after premedication and extended to early postoperative period .
RESULTS	The level of anxiety showed no statistically significant difference between melatonin and gabapentin groups at any time of measurement .
RESULTS	There were significant differences between the pain scores during retrobulbar placement in gabapentin versus placebo ( 95 % CI 3 to 4 ; P = 0.001 ) and melatonin ( 95 % CI 3 to 4 ; P = 0.040 ) groups .
RESULTS	Also , there were significant differences between the sedation scores during retrobulbar placement in gabapentin and placebo groups ( 95 % CI 2 to 2.5 ; P = 0.046 ) .
RESULTS	The difference in sedation scores during retrobulbar placement in melatonin versus gabapentin and placebo groups was not significant .
RESULTS	Neither the intraoperative pain scores nor the postoperative pain scores were different between the three groups .
RESULTS	The surgeon reported similar quality of operation conditions during surgery for the three study groups .
CONCLUSIONS	The level of anxiety was significantly lower with both anxiolytic drugs compared to placebo .
CONCLUSIONS	Furthermore , gabapentin decreased the pain and improved the sedation scores only during retrobulbar placement compared to the placebo .

###26114906
OBJECTIVE	To investigate whether a 12-week physical and cognitive exercise program can improve cognitive function and brain activation efficiency in community-dwelling older adults .
METHODS	Randomized controlled trial .
METHODS	Kyoto , Japan .
METHODS	Community-dwelling older adults ( N = 48 ) were randomized into an exercise group ( n = 24 ) and a control group ( n = 24 ) .
METHODS	Exercise group participants received a weekly dual task-based multimodal exercise class in combination with pedometer-based daily walking exercise during the 12-week intervention phase .
METHODS	Control group participants did not receive any intervention and were instructed to spend their time as usual during the intervention phase .
METHODS	The outcome measures were global cognitive function , memory function , executive function , and brain activation ( measured using functional magnetic resonance imaging ) associated with visual short-term memory .
RESULTS	Exercise group participants had significantly greater postintervention improvement in memory and executive functions than the control group ( P < .05 ) .
RESULTS	In addition , after the intervention , less activation was found in several brain regions associated with visual short-term memory , including the prefrontal cortex , in the exercise group ( P < .001 , uncorrected ) .
CONCLUSIONS	A 12-week physical and cognitive exercise program can improve the efficiency of brain activation during cognitive tasks in older adults , which is associated with improvements in memory and executive function .

###24480335
OBJECTIVE	To explore potential predictors of self-reported paretic arm use at baseline and after task-specific training ( TST ) in survivors of stroke .
METHODS	Data were obtained from a randomized controlled trial of somatosensory stimulation and upper limb TST in chronic stroke .
METHODS	University laboratory .
METHODS	Chronic ( 3mo ) survivors of stroke ( N = 33 ; mean age , 62y ; mean stroke duration , 38mo ) .
METHODS	Participants received 12 sessions of TST preceded by either active ( n = 16 ) or sham ( n = 17 ) somatosensory stimulation to all 3 peripheral nerves .
METHODS	Demographic and clinical characteristics were entered stepwise into multiple linear regression analyses to determine the factors that best predict baseline Motor Activity Log ( MAL ) amount of use rating and change 3 months after TST .
RESULTS	The Action Research Arm Test ( ARAT ) score predicted the amount of use at baseline ( R ( 2 ) = .47 , P < .001 ) ; in using this model , an ARAT score of 54 ( maximum of 57 ) is required to score 2.5 on the MAL ( use described as between rarely and sometimes ) .
RESULTS	After TST the change in the ARAT score predicted the change in the amount of use ( R ( 2 ) = .31 , P = .001 ) .
RESULTS	The predictive power of the model for change at 3 months increased if the Fugl-Meyer Assessment wrist component score was added ( R ( 2 ) = .41 , P = .001 ) .
CONCLUSIONS	Utilization of the paretic upper limb in activities of daily living requires high functional ability .
CONCLUSIONS	The increase in self-reported arm use after TST is dependent on the change in functional ability .
CONCLUSIONS	These results provide further guidance for rehabilitation decisions .

###24269855
BACKGROUND	There are limited data comparing ultrafiltration with standard medical therapy as first-line treatment in patients with severe congestive heart failure ( HF ) .
BACKGROUND	We compared ultrafiltration and conventional therapy in patients hospitalized for HF and overt fluid overload .
RESULTS	Fifty-six patients with congestive HF were randomized to receive standard medical therapy ( control group ; n = 29 ) or ultrafiltration ( ultrafiltration group ; n = 27 ) .
RESULTS	The primary end point of the study was rehospitalizations for congestive HF during a 1-year follow-up .
RESULTS	Despite similar body weight reduction at hospital discharge in the 2 groups ( 7.5 5.5 and 7.9 9.0 kg , respectively ; P = .75 ) , a lower incidence of rehospitalizations for HF was observed in the ultrafiltration-treated patients during the following year ( hazard ratio 0.14 , 95 % confidence interval 0.04-0 .48 ; P = .002 ) .
RESULTS	Ultrafiltration-induced benefit was associated with a more stable renal function , unchanged furosemide dose , and lower B-type natriuretic peptide levels .
RESULTS	At 1 year , 7 deaths ( 30 % ) occurred in the ultrafiltration group and 11 ( 44 % ) in the control group ( P = .33 ) .
CONCLUSIONS	In HF patients with severe fluid overload , first-line treatment with ultrafiltration is associated with a prolonged clinical stabilization and a greater freedom from rehospitalization for congestive HF .

###24954822
OBJECTIVE	Pediatric inflammatory bowel disease ( IBD ) is associated with high rates of depression .
OBJECTIVE	This study compared the efficacy of cognitive behavioral therapy ( CBT ) to supportive nondirective therapy ( SNDT ) in treating youth with comorbid IBD and depression .
METHODS	Youth ( 51 % female and 49 % male ; age 9-17 years , mean age 14.3 years ) with depression and Crohn 's disease ( n = 161 ) or ulcerative colitis ( n = 56 ) were randomly assigned to a 3-month course of CBT or SNDT .
METHODS	The primary outcome was comparative reduction in depressive symptom severity ; secondary outcomes were depression remission , increase in depression response , and improved health-related adjustment and IBD activity .
RESULTS	A total of 178 participants ( 82 % ) completed the 3-month intervention .
RESULTS	Both psychotherapies resulted in significant reductions in total Children 's Depression Rating Scale Revised score ( 37.3 % for CBT and 31.9 % for SNDT ) , but the difference between the 2 treatments was not significant ( p = .16 ) .
RESULTS	There were large pre-post effect sizes for each treatment ( d = 1.31 for CBT and d = 1.30 for SNDT ) .
RESULTS	More than 65 % of youth had a complete remission of depression at 3 months , with no difference between CBT and SNDT ( 67.8 % and 63.2 % , respectively ) .
RESULTS	Compared to SNDT , CBT was associated with a greater reduction in IBD activity ( p = .04 ) but no greater improvement on the Clinical Global Assessment Scale ( p = .06 ) and health-related quality of life ( IMPACT-III scale ) ( p = .07 ) .
CONCLUSIONS	This is the first randomized controlled study to suggest improvements in depression severity , global functioning , quality of life , and disease activity in a physically ill pediatric cohort treated with psychotherapy .
CONCLUSIONS	Clinical trial registration information-Reducing Depressive Symptoms in Physically Ill Youth ; http://clinical trials.gov ; NCT00534911 .

###24950708
BACKGROUND	The HIV/AIDS epidemic continues to disproportionately affect African American communities in the US , particularly those located in urban areas .
BACKGROUND	Despite the fact that HIV is often transmitted from one sexual partner to another , most HIV prevention interventions have focused only on individuals , rather than couples .
BACKGROUND	This five-year study investigates community-based implementation , effectiveness , and sustainability of ` Eban II , ' an evidence-based risk reduction intervention for African-American heterosexual , serodiscordant couples .
METHODS	This hybrid implementation/effectiveness implementation study is guided by organizational change theory as conceptualized in the Texas Christian University Program Change Model ( PCM ) , a model of phased organizational change from exposure to adoption , implementation , and sustainability .
METHODS	The primary implementation aims are to assist 10 community-based organizations ( CBOs ) to implement and sustain Eban II ; specifically , to partner with CBOs to expose providers to the intervention ; facilitate its adoption , implementation and sustainment ; and to evaluate processes and determinants of implementation , effectiveness , fidelity , and sustainment .
METHODS	The primary effectiveness aim is to evaluate the effect of Eban II on participant ( n = 200 couples ) outcomes , specifically incidents of protected sex and proportion of condom use .
METHODS	We will also determine the cost-effectiveness of implementation , as measured by implementation costs and potential cost savings .
METHODS	A mixed methods evaluation will examine implementation at the agency level ; staff members from the CBOs will complete baseline measures of organizational context and climate , while key stakeholders will be interviewed periodically throughout implementation .
METHODS	Effectiveness of Eban II will be assessed using a randomized delayed enrollment ( waitlist ) control design to evaluate the impact of treatment on outcomes at posttest and three-month follow-up .
METHODS	Multi-level hierarchical modeling with a multi-level nested structure will be used to evaluate the effects of agency - and couples-level characteristics on couples-level outcomes ( e.g. , condom use ) .
CONCLUSIONS	This study will produce important information regarding the value of the Eban II program and a theory-guided implementation process and tools designed for use in implementing Eban II and other evidence-based programs in demographically diverse , resource-constrained treatment settings .
BACKGROUND	NCT00644163 .

###24675203
BACKGROUND	The incidence of community-acquired methicillin-resistant Staphylococcus aureus infections is rising at an alarming pace .
BACKGROUND	Effective treatment has historically involved early dbridement and antibiotic administration .
BACKGROUND	This study was designed to prospectively determine the effectiveness of empiric therapy in treating hand infections .
METHODS	A prospective randomized trial was conducted at a level I county hospital .
METHODS	Patients with a hand infection received either empiric intravenous vancomycin at admission or intravenous cefazolin .
METHODS	Outcomes were tracked using severity of infection , appropriate clinical response , and length of stay .
METHODS	Cost-effectiveness was calculated using total cost for each patient in both groups .
METHODS	Statistical analyses were performed .
RESULTS	Forty-six patients were enrolled in the study .
RESULTS	Twenty-four were randomized to cefazolin ( 52.2 percent ) and 22 ( 47.8 percent ) to vancomycin .
RESULTS	There was no statistical difference between cost of treatment ( p < 0.20 ) or mean length of stay ( p < 0.18 ) between the groups .
RESULTS	Patients randomized to cefazolin had higher mean costs of treatment compared with patients who were randomized to vancomycin ( p < 0.05 ) .
RESULTS	Patients with more severe infections had more expensive mean costs of treatment ( p < 0.0001 ) and longer mean length of stay ( p = 0.0002 ) .
RESULTS	Near the end of the study , the incidence of community-acquired methicillin-resistant S. aureus at the authors ' county hospital was discovered to be 72 percent , which caused the study to be terminated prematurely by the institutional review board because of the high incidence precluding further randomization .
CONCLUSIONS	Appropriate early treatment for methicillin-resistant S. aureus has not been definitively established .
CONCLUSIONS	No difference in outcome using cefazolin versus vancomycin as a first-line agent was identified .

###24991733
BACKGROUND	Deficient nitric oxide-soluble guanylate cyclase-cyclic guanosine monophosphate signaling results from endothelial dysfunction and may underlie impaired cardiac relaxation in patients with heart failure with preserved left ventricular ejection fraction ( HFpEF ) and pulmonary hypertension ( PH ) .
BACKGROUND	The acute hemodynamic effects of riociguat , a novel soluble guanylate cyclase stimulator , were characterized in patients with PH and HFpEF .
METHODS	Clinically stable patients receiving standard HF therapy with a left ventricular ejection fraction > 50 % , mean pulmonary artery pressure ( mPAP ) 25 mm Hg , and pulmonary arterial wedge pressure ( PAWP ) > 15 mm Hg at rest were randomized to single oral doses of placebo or riociguat ( 0.5 , 1 , or 2 mg ) .
METHODS	The primary efficacy variable was the peak decrease in mPAP from baseline up to 6 h. Secondary outcomes included hemodynamic and echocardiographic parameters , safety , and pharmacokinetics .
RESULTS	There was no significant change in peak decrease in mPAP with riociguat 2 mg ( n = 10 ) vs placebo ( n = 11 , P = .6 ) .
RESULTS	However , riociguat 2 mg significantly increased stroke volume ( +9 mL [ 95 % CI , 0.4-17 ] ; P = .04 ) and decreased systolic BP ( -12 mm Hg [ 95 % CI , -22 to -1 ] ; P = .03 ) and right ventricular end-diastolic area ( -5.6 cm2 [ 95 % CI , -11 to -0.3 ] ; P = .04 ) , without significantly changing heart rate , PAWP , transpulmonary pressure gradient , or pulmonary vascular resistance .
RESULTS	Riociguat was well tolerated .
CONCLUSIONS	In patients with HFpEF and PH , riociguat was well tolerated , had no significant effect on mPAP , and improved exploratory hemodynamic and echocardiographic parameters .
BACKGROUND	ClinicalTrials.gov ; No. : NCT01172756 ; URL : www.clinicaltrials.gov .

###25409287
OBJECTIVE	Posttraumatic stress disorder ( PTSD ) is prevalent , persistent , and disabling .
OBJECTIVE	Although psychotherapy and pharmacotherapy have proven efficacious in randomized clinical trials , geographic barriers impede rural veterans from engaging in these evidence-based treatments .
OBJECTIVE	To test a telemedicine-based collaborative care model designed to improve engagement in evidence-based treatment of PTSD .
METHODS	The Telemedicine Outreach for PTSD ( TOP ) study used a pragmatic randomized effectiveness trial design with intention-to-treat analyses .
METHODS	Outpatients were recruited from 11 Department of Veterans Affairs ( VA ) community-based outpatient clinics serving predominantly rural veterans .
METHODS	Inclusion required meeting diagnostic criteria for current PTSD according to the Clinician-Administered PTSD Scale .
METHODS	Exclusion criteria included receiving PTSD treatment at a VA medical center or a current diagnosis of schizophrenia , bipolar disorder , or substance dependence .
METHODS	Two hundred sixty-five veterans were enrolled from November 23 , 2009 , through September 28 , 2011 , randomized to usual care ( UC ) or the TOP intervention , and followed up for 12 months .
METHODS	Off-site PTSD care teams located at VA medical centers supported on-site community-based outpatient clinic providers .
METHODS	Off-site PTSD care teams included telephone nurse care managers , telephone pharmacists , telepsychologists , and telepsychiatrists .
METHODS	Nurses conducted care management activities .
METHODS	Pharmacists reviewed medication histories .
METHODS	Psychologists delivered cognitive processing therapy via interactive video .
METHODS	Psychiatrists supervised the team and conducted interactive video psychiatric consultations .
METHODS	The primary outcome was PTSD severity as measured by the Posttraumatic Diagnostic Scale .
METHODS	Process-of-care outcomes included medication prescribing and regimen adherence and initiation of and adherence to cognitive processing therapy .
RESULTS	During the 12-month follow-up period , 73 of the 133 patients randomized to TOP ( 54.9 % ) received cognitive processing therapy compared with 16 of 132 randomized to UC ( 12.1 % ) ( odds ratio , 18.08 [ 95 % CI , 7.96-41 .06 ] ; P < .001 ) .
RESULTS	Patients in the TOP arm had significantly larger decreases in Posttraumatic Diagnostic Scale scores ( from 35.0 to 29.1 ) compared with those in the UC arm ( from 33.5 to 32.1 ) at 6 months ( = -3.81 ; P = .002 ) .
RESULTS	Patients in the TOP arm also had significantly larger decreases in Posttraumatic Diagnostic Scale scores ( from 35.0 to 30.1 ) compared with those in the UC arm ( from 33.5 to 31.7 ) at 12 months ( = -2.49 ; P = .04 ) .
RESULTS	There were no significant group differences in the number of PTSD medications prescribed and adherence to medication regimens were not significant .
RESULTS	Attendance at 8 or more sessions of cognitive processing therapy significantly predicted improvement in Posttraumatic Diagnostic Scale scores ( = -3.86 [ 95 % CI , -7.19 to -0.54 ] ; P = .02 ) and fully mediated the intervention effect at 12 months .
CONCLUSIONS	Telemedicine-based collaborative care can successfully engage rural veterans in evidence-based psychotherapy to improve PTSD outcomes .
BACKGROUND	clinicaltrials.gov Identifier : NCT00821678 .

###25358909
BACKGROUND	Pregnancy is a recognised high risk period for excessive weight gain , contributing to postpartum weight retention and obesity development long-term .
BACKGROUND	We aimed to reduce postpartum weight retention following a low-intensity , self-management intervention integrated with routine antenatal care during pregnancy .
METHODS	228 women at increased risk of gestational diabetes , < 15 weeks gestation were randomised to intervention ( 4 self-management sessions ) or control ( generic health information ) .
METHODS	Outcomes , collected at baseline and 6 weeks postpartum , included anthropometrics ( weight and height ) , physical activity ( pedometer ) and questionnaires ( health behaviours ) .
RESULTS	Mean age ( 32.34.7 and 31.74.4 years ) and body mass index ( 30.45.6 and 30.35.9 kg/m2 ) were similar between intervention and control groups , respectively at baseline .
RESULTS	By 6 weeks postpartum , weight change in the control group was significantly higher than the intervention group with a between group difference of 1.455.1 kg ( 95 % CI : -2.86 , -0.02 ; p < 0.05 ) overall , with a greater difference in weight found in overweight , but not obese women .
RESULTS	Intervention group allocation , higher baseline BMI , GDM diagnosis , country of birth and higher age were all independent predictors of lower weight retention at 6 weeks postpartum on multivariable linear regression .
RESULTS	Other factors related to weight including physical activity , did not differ between groups .
CONCLUSIONS	A low intensity intervention , integrated with standard antenatal care is effective in limiting postpartum weight retention .
CONCLUSIONS	Implementation research is now required for scale-up to optimise antenatal health care .
BACKGROUND	Australian New Zealand Clinical Trial Registry Number : ACTRN12608000233325 .
BACKGROUND	Registered 7/5/2008 .

###25305506
OBJECTIVE	Categorization of colon cancers into distinct subtypes using a combination of pathway-based biomarkers could provide insight into stage-independent variability in outcomes .
METHODS	We used a polymerase chain reaction-based assay to detect mutations in BRAF ( V600E ) and in KRAS in 2720 stage III cancer samples , collected prospectively from patients participating in an adjuvant chemotherapy trial ( NCCTG N0147 ) .
METHODS	Tumors deficient or proficient in DNA mismatch repair ( MMR ) were identified based on detection of MLH1 , MSH2 , and MSH6 proteins and methylation of the MLH1 promoter .
METHODS	Findings were validated using tumor samples from a separate set of patients with stage III cancer ( n = 783 ) .
METHODS	Association with 5-year disease-free survival was evaluated using Cox proportional hazards models .
RESULTS	Tumors were categorized into 5 subtypes based on MMR status and detection of BRAF or KRAS mutations which were mutually exclusive .
RESULTS	Three subtypes were MMR proficient : those with mutations in BRAF ( 6.9 % of samples ) , mutations in KRAS ( 35 % ) , or tumors lacking either BRAF or KRAS mutations ( 49 % ) .
RESULTS	Two subtypes were MMR deficient : the sporadic type ( 6.8 % ) with BRAF mutation and/or or hypermethylation of MLH1 and the familial type ( 2.6 % ) , which lacked BRAF ( V600E ) or hypermethylation of MLH1 .
RESULTS	A higher percentage of MMR-proficient tumors with BRAF ( V600E ) were proximal ( 76 % ) , high-grade ( 44 % ) , N2 stage ( 59 % ) , and detected in women ( 59 % ) , compared with MMR-proficient tumors without BRAF ( V600E ) or KRAS mutations ( 33 % , 19 % , 41 % , and 42 % , respectively ; all P < .0001 ) .
RESULTS	A significantly lower proportion of patients with MMR-proficient tumors with mutant BRAF ( hazard ratio = 1.43 ; 95 % confidence interval : 1.11-1 .85 ; Padjusted = .0065 ) or mutant KRAS ( hazard ratio = 1.48 ; 95 % confidence interval : 1.27-1 .74 ; Padjusted < .0001 ) survived disease-free for 5 years compared with patients whose MMR-proficient tumors lacked mutations in either gene .
RESULTS	Disease-free survival rates of patients with MMR-deficient sporadic or familial subtypes was similar to those of patients with MMR-proficient tumors without BRAF or KRAS mutations .
RESULTS	The observed differences in survival rates of patients with different tumor subtypes were validated in an independent cohort .
CONCLUSIONS	We identified subtypes of stage III colon cancer , based on detection of mutations in BRAF ( V600E ) or KRAS , and MMR status that show differences in clinical and pathologic features and disease-free survival .
CONCLUSIONS	Patients with MMR-proficient tumors and BRAF or KRAS mutations had statistically shorter survival times than patients whose tumors lacked these mutations .
CONCLUSIONS	The tumor subtype found in nearly half of the study cohort ( MMR-proficient without BRAF ( V600E ) or KRAS mutations ) had similar outcomes to those of patients with MMR-deficient cancers .

###25886200
BACKGROUND	This paper is embedded in a randomised controlled trial ( Alcohol and Employment ) that investigated whether welfare-to-work schemes combined with alcohol treatment were more effective than welfare-to-work schemes alone for helping unemployed welfare recipients with alcohol problems get back to employment and reduce their alcohol problems .
BACKGROUND	The implementation of Alcohol and Employment turned out to be challenging , and fewer welfare recipients than expected were enrolled .
BACKGROUND	The aim of this paper was to identify and investigate obstacles to the implementation of Alcohol and Employment .
BACKGROUND	Our main objective was to study the job consultants ' role in the implementation process as they were key personnel in conducting the trial .
METHODS	The process evaluation was conducted in four Danish municipalities in 2011-2012 .
METHODS	Data for identifying factors important for the implementation were collected through observations and focus group interviews with job consultants .
METHODS	Data were analysed thematically and thoroughly discussed among members of the project team ; emerging themes were then grouped and read again repeatedly until the themes were consistent .
RESULTS	Three themes emerged as the main factors influencing the degree of implementation of Alcohol and Employment : ( 1 ) The job consultants ' personal attitudes toward alcohol were an important factor .
RESULTS	The job consultants generally did not consider a high alcohol intake to be an impediment to employment , or they thought that alcohol problems were only symptoms of more profound problems .
RESULTS	( 2 ) The job consultants ' perception of their own roles and responsibilities in relation to the welfare recipients was a barrier : they felt that addressing alcohol problems and at the same time sustaining trust with the welfare recipient was difficult .
RESULTS	Also , they did not consider alcohol problems to be their responsibility .
RESULTS	( 3 ) Shortage of time and resources among the job consultants was determined to be an influential factor .
CONCLUSIONS	We identified important factors at the individual level among the job consultants who threatened the implementation of Alcohol and Employment .
CONCLUSIONS	Future studies in similar settings can take advantage of these findings when preparing interventions that are implemented by job consultants or similar professionals .
BACKGROUND	ClinicalTrials.gov ID : NCT01416103 .

###24590734
BACKGROUND	We designed a continuing medical education ( CME ) program to teach primary care physicians ( PCP ) how to engage in cancer risk communication and shared decision making with patients who have limited health literacy ( HL ) .
OBJECTIVE	We evaluated whether training PCPs , in addition to audit-feedback , improves their communication behaviors and increases cancer screening among patients with limited HL to a greater extent than only providing clinical performance feedback .
METHODS	Four-year cluster randomized controlled trial .
METHODS	Eighteen PCPs and 168 patients with limited HL who were overdue for colorectal/breast/cervical cancer screening .
METHODS	Communication intervention PCPs received skills training that included standardized patient ( SP ) feedback on counseling behaviors .
METHODS	All PCPs underwent chart audits of patients ' screening status semiannually up to 24 months and received two annual performance feedback reports .
METHODS	PCPs experienced three unannounced SP encounters during which SPs rated PCP communication behaviors .
METHODS	We examined between-group differences in changes in SP ratings and patient knowledge of cancer screening guidelines over 12 months ; and changes in patient cancer screening rates over 24 months .
RESULTS	There were no group differences in SP ratings of physician communication at baseline .
RESULTS	At follow-up , communication intervention PCPs were rated higher in general communication about cancer risks and shared decision making related to colorectal cancer screening compared to PCPs who only received performance feedback .
RESULTS	Screening rates increased among patients of PCPs in both groups ; however , there were no between-group differences in screening rates except for mammography .
RESULTS	The communication intervention did not improve patient cancer screening knowledge .
CONCLUSIONS	Compared to audit and feedback alone , including PCP communication training increases PCP patient-centered counseling behaviors , but not cancer screening among patients with limited HL .
CONCLUSIONS	Larger studies must be conducted to determine whether lack of changes in cancer screening were due to clinic/patient sample size versus ineffectiveness of communication training to change outcomes .

###25863661
OBJECTIVE	To investigate the safety and short term outcome of high dose recombinant human erythropoietin ( rhEpo ) given shortly after birth and subsequently over the first 2 days for neuroprotection to very preterm infants .
METHODS	Randomized , double masked phase II trial .
METHODS	Preterm infants ( gestational age 26 0/7 -31 6/7 weeks ) were given rhEpo ( nt = 229 ; 3000 U/kg body weight ) or NaCl 0.9 % ( nc = 214 ) intravenously at 3 , 12-18 , and 36-42 hours after birth .
RESULTS	There were no relevant differences between the groups for short-term outcomes such as mortality , retinopathy of prematurity , intraventricular hemorrhage , sepsis , necrotizing enterocolitis , and bronchopulmonary dysplasia .
RESULTS	At day 7-10 , we found significantly higher hematocrit values , reticulocyte , and white blood cell counts , and a lower platelet count in the rhEpo group .
CONCLUSIONS	Early high-dose rhEpo administration to very premature infants is safe and causes no excess in mortality or major adverse events .
BACKGROUND	ClinicalTrials.gov : NCT00413946 .

###26222557
BACKGROUND	Delayed graft function , which is reported in up to 50 % of kidney-transplant recipients , is associated with increased costs and diminished long-term graft function .
BACKGROUND	The effect that targeted mild hypothermia in organ donors before organ recovery has on the rate of delayed graft function is unclear .
METHODS	We enrolled organ donors ( after declaration of death according to neurologic criteria ) from two large donation service areas and randomly assigned them to one of two targeted temperature ranges : 34 to 35C ( hypothermia ) or 36.5 to 37.5 C ( normothermia ) .
METHODS	Temperature protocols , which were initiated after authorization was obtained for the organ to be donated and for the donor 's participation in the study , ended when organ donors left the intensive care unit for organ recovery in the operating room .
METHODS	The primary outcome was delayed graft function in the kidney recipients , which was defined as the requirement for dialysis during the first week after transplantation .
METHODS	Secondary outcomes were the rates of individual organs transplanted in each treatment group and the total number of organs transplanted from each donor .
RESULTS	The study was terminated early , on the recommendation of an independent data and safety monitoring board , after the interim analysis showed efficacy of hypothermia .
RESULTS	At trial termination , 370 organ donors had been enrolled ( 180 in the hypothermia group and 190 in the normothermia group ) .
RESULTS	A total of 572 patients received a kidney transplant ( 285 kidneys from donors in the hypothermia group and 287 kidneys from donors in the normothermia group ) .
RESULTS	Delayed graft function developed in 79 recipients of kidneys from donors in the hypothermia group ( 28 % ) and in 112 recipients of kidneys from donors in the normothermia group ( 39 % ) ( odds ratio , 0.62 ; 95 % confidence interval , 0.43 to 0.92 ; P = 0.02 ) .
CONCLUSIONS	Mild hypothermia , as compared with normothermia , in organ donors after declaration of death according to neurologic criteria significantly reduced the rate of delayed graft function among recipients .
CONCLUSIONS	( Funded by the Health Resources and Services Administration ; ClinicalTrials.gov number , NCT01680744 . )

###25468506
BACKGROUND	Antipsychotics are commonly used for management of behavioural symptoms in dementia , among people in residential care .
BACKGROUND	This continues to occur despite their modest effectiveness , potential harms including increased risk of death and stroke , and absence of detrimental effect when people with dementia were randomised to antipsychotic withdrawal .
BACKGROUND	This study aims to test the hypothesis that the multifaceted REducing Anti-Psychotic use in residential care-Huntington Disease ( REAP-HD ) programme is more effective than standard staff education ( SSE ) in reducing antipsychotic use for people with HD in residential care facilities ( RCF ) .
METHODS	this is a cluster randomised controlled trial with blinded outcome assessment .
METHODS	The study population is healthcare professionals looking after people with HD in individual RCF , in the state of New South Wales .
METHODS	Each RCF will be centrally randomised to the REAP-HD programme or the comparator , SSE .
METHODS	Blinded outcome assessment will be performed by examining drug charts and using the Neuropsychiatric Inventory-Q ( NPI-Q ) .
METHODS	Primary outcome is the proportion of people with HD who have had a reduction in antipsychotic use 4 months after the intervention .
METHODS	Secondary outcome measures are ( 1 ) change in severity of behavioural symptoms , as measured by the NPI-Q at 4 months ( to ensure antipsychotic reduction has not lead to worsening behavioural symptoms ) , and ( 2 ) proportion of people with HD who have had a reduction in antipsychotic dosage at 4 months for each strategy , compared to 4 months prior to enrolment ( to capture the possibility that both arms reduced antipsychotic use ) .
METHODS	Analysis will be by Intention-To-Treat and take into account the clustering .
METHODS	Recruitment is ongoing , as of July 2014 .
BACKGROUND	This protocol has been approved by the Western Sydney Local Health District Human Research Ethics Committee , trial registration ACTRN12614000083695 .
BACKGROUND	Study results will be disseminated through peer-reviewed publication in an anonymous manner .
BACKGROUND	ACTRN12614000083695 , the Australian New Zealand Clinical Trials Registry .

###25182625
OBJECTIVE	The objective of this study was to investigate the association of spirometry and pulmonary CT biomarkers with cardiovascular events .
METHODS	In this lung cancer screening trial 3,080 male participants without a prior cardiovascular event were analysed .
METHODS	Fatal and non-fatal cardiovascular events were included .
METHODS	Spirometry included forced expiratory volume measured in units of one-second percent predicted ( FEV1 % predicted ) and FEV1 divided by forced vital capacity ( FVC ; FEV1/FVC ) .
METHODS	CT examinations were quantified for coronary artery calcium volume , pulmonary emphysema ( perc15 ) and bronchial wall thickness ( pi10 ) .
METHODS	Data were analysed via a Cox proportional hazard analysis , net reclassification improvement ( NRI ) and C-indices .
RESULTS	184 participants experienced a cardiovascular event during a median follow-up of 2.9 years .
RESULTS	Age , pack-years and smoking status adjusted hazard ratios were 0.992 ( 95 % confidence interval ( CI ) 0.985-0 .999 ) for FEV1 % predicted , 1.000 ( 95 % CI 0.986-1 .015 ) for FEV1/FVC , 1.014 ( 95 % CI 1.005-1 .023 ) for perc15 per 10 HU , and 1.269 ( 95 % CI 1.024-1 .573 ) for pi10 per 1 mm .
RESULTS	The incremental C-index ( < 0.015 ) and NRI ( < 2.8 % ) were minimal .
RESULTS	Coronary artery calcium volume had a hazard ratio of 1.046 ( 95 % CI 1.034-1 .058 ) per 100 mm ( 3 ) , an increase in C-index of 0.076 and an NRI of 16.9 % ( P < 0.0001 ) .
CONCLUSIONS	Pulmonary CT biomarkers and spirometry measurements were significantly associated with cardiovascular events , but did not contain clinically relevant independent prognostic information for cardiovascular events .
CONCLUSIONS	Pulmonary CT biomarkers and spirometry are associated with cardiovascular events These pulmonary measurements do not contain clinically relevant independent prognostic information Only coronary calcium score improved cardiovascular risk prediction above age and smoking .

###24885192
BACKGROUND	Effective and safe management of oral anticoagulant treatment ( OAT ) requires a high level of patient knowledge and adherence .
BACKGROUND	The aim of this study was to assess patient knowledge about OAT and factors associated with patient knowledge .
METHODS	This is a baseline survey of a cluster-randomized controlled trial in 22 general practices with an educational intervention for patients or their caregivers .
METHODS	We assessed knowledge about general information on OAT and key facts regarding nutrition , drug-interactions and other safety precautions of 345 patients at baseline .
RESULTS	Participants rated their knowledge about OAT as excellent to good ( 56 % ) , moderate ( 36 % ) or poor ( 8 % ) .
RESULTS	However , there was a discrepancy between self-rated knowledge and evaluated actual knowledge and we observed serious knowledge gaps .
RESULTS	Half of the participants ( 49 % ) were unaware of dietary recommendations .
RESULTS	The majority ( 80 % ) did not know which non-prescription analgesic is the safest and 73 % indicated they would not inform pharmacists about OAT .
RESULTS	Many participants ( 35-75 % ) would not recognize important emergency situations .
RESULTS	After adjustment in a multivariate analysis , older age and less than 10 years education remained significantly associated with lower overall score , but not with self-rated knowledge .
CONCLUSIONS	Patients have relevant knowledge gaps , potentially affecting safe and effective OAT .
CONCLUSIONS	There is a need to assess patient knowledge and for structured education programs .
BACKGROUND	Deutsches Register Klinischer Studien ( German Clinical Trials Register ) : DRKS00000586.Universal Trial Number ( UTN U1111-1118-3464 ) .

###25797356
OBJECTIVE	The optimal second-line regimen for treating advanced gastric cancer ( AGC ) remains unclear .
OBJECTIVE	While irinotecan ( CPT-11 ) plus cisplatin ( CDDP ) combination therapy and CPT-11 monotherapy have been explored in the second-line setting , the superiority of second-line platinum-based therapies for AGC patients initially treated with S-1 monotherapy has not yet been evaluated ; therefore , we aimed to examine the survival benefit of CPT-11 / CDDP combination over CPT-11 monotherapy .
METHODS	AGC patients showing progression after S-1 monotherapy for advanced cancer or recurrence within 6 months after completion of S-1 adjuvant therapy were randomly allocated to CPT-11 / CDDP ( CPT-11 , 60 mg/m ( 2 ) ; CDDP , 30 mg/m ( 2 ) , q2w ) or CPT-11 ( 150 mg/m ( 2 ) , q2w ) .
RESULTS	Sixty-eight advanced and 95 recurrent cases were evaluated .
RESULTS	The median overall survivals were 13.9 ( 95 % confidence interval [ CI ] : 10.8-17 .6 ) and 12.7 ( 95 % CI : 10.3-17 .2 ) months for CPT-11 / CDDP and CPT-11 , respectively ( hazard ratio : 0.834 ; 95 % CI : 0.596-1 .167 , P = 0.288 ) .
RESULTS	No significant differences were observed in the secondary end-points , including progression-free survival ( 4.6 [ 95 % CI : 3.4-5 .9 ] versus 4.1 [ 95 % CI : 3.3-4 .9 ] months ) and response rate ( 16.9 % [ 95 % CI : 8.8-28 .3 ] versus 15.4 % [ 95 % CI : 7.6-26 .5 ] ) .
RESULTS	The incidences of grade 3-4 anaemia ( 16 % versus 4 % ) and elevated serum lactate dehydrogenase levels ( 5 % versus 0 % ) were higher for CPT-11 / CDDP than for CPT-11 .
RESULTS	Exploratory subgroup analysis revealed that CPT-11 / CDDP was significantly more effective for intestinal-type AGC , compared with CPT-11 ( overall survival : 15.8 versus 14.0 months ; P = 0.019 ) .
CONCLUSIONS	No survival benefit was observed upon adding CDDP to CPT-11 after S-1 monotherapy failure .

###24532143
OBJECTIVE	Postoperative delirium is the most common postoperative complication in the elderly .
OBJECTIVE	The purpose of this study was to evaluate the safety and effectiveness of the preventive administration of low-dose haloperidol on the development of postoperative delirium after abdominal or orthopedic surgery in elderly patients .
METHODS	A total of 119 patients aged 75 years or older who underwent elective surgery for digestive or orthopedic disease were included in this study .
METHODS	Patients were divided into those who did ( intervention group , n = 59 ) and did not ( control group , n = 60 ) receive 2.5 mg of haloperidol at 18:00 daily for 3 days after surgery ; a randomized , open-label prospective study was performed on these groups .
METHODS	The primary endpoint was the incidence of postoperative delirium during the first 7 days after the operation .
RESULTS	The incidence of postoperative delirium in all patients was 37.8 % .
RESULTS	No side effects involving haloperidol were noted ; however , the incidences of postoperative delirium were 42.4 and 33.3 % in the intervention and control groups , respectively , which were not significantly different ( p = 0.309 ) .
RESULTS	No significant effect of the treatment was observed on the severity or persistence of postoperative delirium .
CONCLUSIONS	The preventive administration of low-dose haloperidol did not induce any adverse events , but also did not significantly decrease the incidence or severity of postoperative delirium or shorten its persistence .

###24802626
BACKGROUND	There are insufficient data to guide perioperative implantable cardioverter-defibrillator ( ICD ) management for patients undergoing surgical procedures using electrocautery .
METHODS	We conducted a multicenter randomized controlled trial of patients with ICDs undergoing surgery with monopolar electrocautery .
METHODS	Subjects were randomized to an `` Off '' group ( ICD therapy programmed off , then postoperatively programmed on ) or a `` Magnet '' group ( ICD therapy suspended with a magnet and no immediate postoperative ICD interrogation ) .
METHODS	Also , a registry was maintained of ICD patients with procedures within 6 inches of the ICD ( all programmed off ) .
METHODS	The primary endpoint was ICD off time with secondary endpoints being caregiver handoffs and incidence of electromagnetic interference ( EMI ) .
RESULTS	All patients ( n = 80 ) had pectoral ICDs .
RESULTS	Subject demographics were well matched in each group , and duration of electrocautery was similar ( 80 minutes vs 64 minutes , P = 0.58 ) .
RESULTS	The mean `` excess '' ICD off time ( ICD off time - electrocautery time ) was significantly higher in the Off group than the Magnet group ( 115 minutes vs 28 minutes , P < 0.001 ) .
RESULTS	Mean number of caregiver handoffs were higher in the Off group ( 6.6 vs 5.5 , P < 0.001 ) .
RESULTS	There was no EMI in any lower abdominal or lower extremity procedures .
RESULTS	Neither group had arrhythmic events or device reset .
CONCLUSIONS	A magnet protocol simplifies perioperative ICD management for procedures using electrocautery more than 6 inches from the ICD .
CONCLUSIONS	This protocol results in significantly shorter time with ICD therapy off , fewer provider handoffs , no risk of inadvertently discharging patients home with ICD therapies off , and no device reset .

###24995890
BACKGROUND	This phase 2 study examined the efficacy and tolerability of edivoxetine , a highly selective norepinephrine reuptake inhibitor , as an adjunctive treatment for patients with major depressive disorder ( MDD ) who have a partial response to selective serotonin reuptake inhibitor ( SSRI ) treatment .
METHODS	Study design consisted of double-blind , 10-week therapy of adjunctive edivoxetine ( 6-18 mg once daily ) or adjunctive placebo with SSRI .
METHODS	Inclusion/entry criteria included partial response to current SSRI by investigator opinion and a GRID 17-item Hamilton Rating Scale for Depression ( HAMD17 ) total score 16 .
METHODS	The primary efficacy measure was the Montgomery-Asberg Depression Rating Scale ( MADRS ) .
METHODS	Safety measures included treatment-emergent adverse events ( TEAE ) and vital signs .
RESULTS	For the primary evaluable population ( n = 63 for adjunctive edivoxetine and n = 68 for adjunctive placebo ) , the treatment groups did not differ significantly on the primary outcome of change from baseline to week 8 in the MADRS total score ; the effect size of edivoxetine treatment was 0.26 .
RESULTS	Significant treatment differences , favoring adjunctive edivoxetine ( p. 05 ) , were shown for improvements in role functioning and the functional impact of fatigue .
RESULTS	For the adjunctive edivoxetine randomized group ( N = 111 ) , the most frequent TEAEs were hyperhidrosis ( 7.2 % ) , nausea ( 7.2 % ) , erectile dysfunction ( 6.3 % ) and testicular pain ( 6.3 % ) .
RESULTS	Hemodynamic changes were observed in blood pressure and pulse rate between treatment groups .
CONCLUSIONS	Study was underpowered for an alpha 2-sided 0.05 significance level for the primary outcome .
CONCLUSIONS	For patients with MDD who had a partial response to SSRIs , adjunctive edivoxetine treatment was not statistically superior to adjunctive placebo on the primary outcome measure .
CONCLUSIONS	However , pending further study , improved functioning and remission rate suggest a potential role for edivoxetine for patients with depression .

###24434160
OBJECTIVE	We assessed the effectiveness of the Luoghi di Prevenzione-Prevention Grounds school-based smoking prevention programme .
METHODS	We undertook a cluster randomized controlled trial of 989 students aged 14-15 years in 13 secondary schools located in Reggio Emilia , Italy .
METHODS	The intervention consisted of the `` Smoking Prevention Tour '' ( SPT ) out-of-school workshop , one in-depth lesson on one Smoking Prevention Tour topic , a life-skills peer-led intervention , and enforcement surveillance of school antismoking policy .
METHODS	Self-reported past 30-day smoking of 20 or 1-19 days of cigarette smoking ( daily or frequent smoking , respectively ) was recorded in 2 surveys administered immediately before and 18 months after the beginning of the programme .
METHODS	Analysis was by intention to treat .
METHODS	The effect of the intervention was evaluated using random effects logistic regression and propensity score-matching analyses .
RESULTS	Past 30-day smoking and daily cigarette use at eighteen months follow-up were 31 % and 46 % lower , respectively , for intervention students compared to control students .
RESULTS	Taking into account non-smokers at baseline only , daily smoking at eighteen months follow-up was 59 % lower in intervention students than in controls .
RESULTS	Past 30-day smoking in school areas was 62 % lower in intervention students compared to controls .
CONCLUSIONS	The Luoghi di Prevenzione-Prevention Grounds programme was effective in reducing daily smokers and in reducing smoking in school areas .

###24890683
OBJECTIVE	To assess the efficacy of dapagliflozin , a sodium-glucose cotransporter 2 inhibitor , for the treatment of individuals with type 2 diabetes mellitus ( T2DM ) and preexisting cardiovascular disease ( CVD ) .
METHODS	Randomized , double-blind , age-stratified ( < 65 and 65 ) , 24-week clinical trial with a 28-week extension .
METHODS	One hundred seventy-three centers in 10 countries .
METHODS	Individuals ( N = 964 ) with T2DM , glycosylated hemoglobin ( HbA1c ) of 7.0 % to 10.0 % , and documented CVD .
METHODS	Dapagliflozin 10 mg/d or placebo was added to usual care .
METHODS	Participants receiving insulin had their total daily insulin dose reduced by 25 % at randomization .
METHODS	Two equal primary end points : change from baseline in HbA1c and proportion of participants achieving a three-item end point ( reduction of 0.5 % in HbA1c , 3 % in body weight , and 3 mmHg in systolic blood pressure ) at 24 weeks .
RESULTS	Forty-seven percent were aged 65 and older , 7.7 % were aged 75 and older , mean duration of T2DM was 13 years , mean baseline HbA1c was 8.1 % , and approximately 60 % were taking insulin .
RESULTS	The placebo-corrected change in HbA1c with dapagliflozin was -0.4 % at 24 weeks .
RESULTS	Significantly more participants achieved the three-item end point with dapagliflozin ( 10.0 % ) than with placebo ( 1.9 % ) .
RESULTS	The placebo-corrected percentage change in body weight for dapagliflozin was -1.9 % ( -1.8 kg ) .
RESULTS	Similar results were observed in both age strata , and changes were maintained over 52 weeks .
RESULTS	More than one-quarter ( 28.2 % ) of participants receiving dapagliflozin and 25.3 % of those receiving placebo experienced hypoglycemia .
RESULTS	More participants receiving dapagliflozin had vulvovaginitis , balanitis , or urinary tract infection .
CONCLUSIONS	When added to a usual background regimen in an older population with advanced T2DM and preexisting comorbid CVD , dapagliflozin improved glycemic control without an increase in hypoglycemic risk , promoted weight loss , and was well tolerated .

###24565750
OBJECTIVE	A recent international , multicenter , double-blinded , randomized trial shows delayed-enhanced magnetic resonance imaging ( DE-MRI ) using contrast doses of 0.2 mmol/kg is effective in the detection and assessment of myocardial infarction ( MI ) , and 0.1 mmol/kg is not enough ; intermediate doses between 0.1 and 0.2 mmol/kg have not been tested .
OBJECTIVE	The aim of this study was to prospectively test the performance of DE-MRI using 0.15 mmol/kg of contrast agent for the detection of MI .
METHODS	A total of 31 consecutive patients with chronic MI underwent DE-MRI at 3.0 T using both 0.15 mmol/kg and 0.2 mmol/kg of contrast agent in random order and on separate days .
METHODS	Infarction segment and infarction size were compared on DE-MRI images using a 17-segment model .
METHODS	Bland-Altman analysis was used to analyze correlation and agreement between global infarct sizes .
RESULTS	DE-MRI showed enhanced myocardium in all the 31 patients with chronic MI .
RESULTS	There was no significant difference between the 0.15 mmol/kg and 0.2 mmol/kg images in all 31 patients based on the infarction segment ( 7.872.72 vs. 7.812.64 , respectively ; p = 0.33 ) .
RESULTS	There was no significant difference between the infarction size obtained from 0.15 mmol/kg acquisition and that from 0.2 mmol/kg acquisition ( 16.37.8 % vs. 16.47.9 % , respectively ; p = 0.87 ) .
RESULTS	A strong correlation between the infarction size obtained from 0.15 mmol/kg acquisition and that from 0.2 mmol/kg acquisition was indicated through Bland-Altman analysis .
CONCLUSIONS	DE-MRI at 3.0 T using 0.15 mmol/kg of contrast agent is effective for the assessment of MI .

###24468920
OBJECTIVE	A sudden gain is defined as a large and stable individual improvement occurring between two consecutive treatment sessions .
OBJECTIVE	Sudden gains have been shown to predict better long-term improvement in several treatment studies , including cognitive behavioural therapy for depression and anxiety disorders , but have not been studied in the treatment of health anxiety or any form of internet-based cognitive behavioural therapy .
OBJECTIVE	The aim of this study was to investigate the role of sudden gains in internet-based cognitive behavioural therapy for severe health anxiety .
METHODS	We examined the occurrence and significance of sudden gains in measures of health anxiety in 81 participants receiving internet-based cognitive behavioural therapy .
METHODS	We compared patients with sudden gains , patients without sudden gains , and patients with gradual gains .
RESULTS	Thirteen participants ( 16 % ) experienced one sudden gain in health anxiety with individual sudden gains distributed across the treatment .
RESULTS	As expected , patients with a sudden gain showed larger improvements than patients without a sudden gain at post-treatment ( d = 1.04 ) and at one-year follow-up ( d = 0.91 ) on measures of health anxiety .
CONCLUSIONS	Consistent with previous studies , sudden gains in internet-based cognitive behavioural therapy are associated with significantly larger and stable treatment effects up to one-year follow-up .

###25534310
BACKGROUND	Same-sex attracted young adults have been found to experience higher rates of mental health problems and greater difficulties in accessing specialist mental health care services compared to their heterosexual peers .
BACKGROUND	Internet-based mental health interventions have the potential to be more engaging and accessible to young adults compared to those delivered face-to-face .
BACKGROUND	However , they are rarely inclusive of lesbian women and gay men .
BACKGROUND	Thus , the current study aims to evaluate the effectiveness of an online mental health and wellbeing program , Out & Online ( http://www.outandonline.org.au ) , in comparison to a wait-list control group , for reducing anxiety and depressive symptoms in same-sex attracted young adults aged between 18 and 25 years .
METHODS	We are recruiting , through media and community organisations , 200 same-sex attracted young adults with anxiety and/or depressive symptoms and mild to moderate psychological distress ( Kessler-10 score between 16 to 21 ) .
METHODS	Participants will be randomly allocated to the intervention ( the online program ) or the wait-list control group based on a permuted blocked randomisation method to allow for stratification by gender .
METHODS	Participants in the intervention group will receive a tailored program for up to three types of mental health difficulties simultaneously .
METHODS	The primary outcome of anxiety and/or depressive symptoms , and secondary outcomes related to psychological distress , wellbeing and health behaviour will be measured at pre-intervention ( 0 week ) , post-intervention ( 8 weeks ) and at a 3-month follow-up ( 20 weeks ) .
CONCLUSIONS	This online mental health and wellbeing program will be one of the first online interventions to be designed specifically to be relevant for same-sex attracted individuals .
CONCLUSIONS	If the program is found to be effective it will improve access to specialist same-sex attracted-relevant mental health services for young adults and will facilitate wellbeing outcomes for these individuals .
CONCLUSIONS	This program will also be a significant development in the delivery of tailored interventions that target multiple types of mental health conditions simultaneously .
BACKGROUND	Australian New Zealand Clinical Trials Registry : ACTRN12611000700932 .
BACKGROUND	Date registered : 7 July 2011 .

###24996447
BACKGROUND	Endometriosis affects fertility negatively .
BACKGROUND	The study aims to evaluate whether laparoscopic surgery combined with oral contraceptive or herbs were more effective than laparoscopic alone in improving fecundity and pelvic pain in women with minimal/mild endometriosis .
METHODS	A randomized controlled trial ( RCT ) was conducted in 156 infertile women with minimal/mild endometriosis .
METHODS	After laparoscopic surgery , patients were randomized to three groups : in Group A ( n = 52 ) oral contraceptive ( OC ) was administered one pill a day , continuous for 63days without intervals , in Group B ( n = 52 ) OC was administered as above and then Dan ' e mixture was added 30g/day for the latter 30days , and in control Group C ( n = 52 ) patients tried to get pregnant after surgery without complementary treatment .
METHODS	The follow-up periods were 12months in Group C and 14months in complementary medical treatment Group A and B.
METHODS	The pregnant women were further followed up , and labor and pregnancy outcomes were assessed .
METHODS	Primary outcome was pregnancy rate ( PR ) and live birth rate ( LBR ) .
METHODS	Secondary outcomes included changes of pelvic pain visual analog scale scores and side effects .
METHODS	Analyses were done as intention-to-treat .
RESULTS	The PR was 46.80 % ( 73/156 ) , and the LBR was 69.86 % ( 51/73 ) .
RESULTS	Of the 73 pregnancies , 60 occurred within 12months of follow-up and 7 of the remaining 13 patients underwent assisted reproductive technology for > 1year .
RESULTS	No significant difference was observed in PR and LBR among the three groups .
RESULTS	Patients given medical treatment ( OCs or OCs plus herbal medicine ) had significantly decreased pain scores compared with the laparoscopy alone group .
CONCLUSIONS	Combination of laparoscopy with OCs or OCs and herbal medicine does not have more advantages than laparoscopy alone in improving fertility of women with minimal/mild endometriosis .
BACKGROUND	ChiCTR-TRC-11001820 .

###24393346
OBJECTIVE	To explore the effect of continuous nursing intervention guided by chronotherapeutics so as to provide the easy , noninvasive , effective and acceptable intervention for older hypertensive patients in the community .
BACKGROUND	Many researchers studied the effect of administration at different times on blood pressure control and circadian rhythm .
BACKGROUND	However , the individual administrative time was set ambiguously in previous studies .
METHODS	A semi-experimental study .
METHODS	In the study , 90 eligible patients were recruited and separated into three groups randomly , which were the control group , intervention group A ( behaviour and chronotherapy intervention ) and intervention group B ( behaviour intervention ) .
METHODS	At 6 and 12months after the study , the intervention groups were measured 24-hour ambulatory blood pressure monitoring .
RESULTS	There were significant differences in ambulatory blood pressure monitoring parameters of the two intervention groups at different measurement times , and there were interaction between measurement time and different groups .
RESULTS	The number of patients with dipper increased and reverse dipper decreased in group A as the intervention applied .
RESULTS	There were statistical differences between two groups .
RESULTS	The number of patients with morning surge in group A decreased more , and there were statistical differences between two groups at six months after the intervention .
CONCLUSIONS	The behaviour and chronotherapy intervention based on the patients ' ambulatory blood pressure monitoring can control casual blood pressure much better and last longer , which can also improve patients ' indexes of ambulatory blood pressure monitoring better than behaviour intervention only .
CONCLUSIONS	The behaviour and chronotherapy intervention can increase patients ' nocturnal blood pressure drop , increase the number of patients with dipper and decrease reverse dipper , and improve blood pressure surge in the morning .
CONCLUSIONS	Nurses can use continuous nursing intervention guided by chronotherapeutics to help improve hypertension of older patients better in the community .

###24262772
OBJECTIVE	To test the impact of the method of administration ( MOA ) on score level , reliability , and validity of scales developed in the Patient Reported Outcomes Measurement Information System ( PROMIS ) .
METHODS	Two nonoverlapping parallel forms each containing eight items from each of three PROMIS item banks ( Physical Function , Fatigue , and Depression ) were completed by 923 adults with chronic obstructive pulmonary disease , depression , or rheumatoid arthritis .
METHODS	In a randomized crossover design , subjects answered one form by interactive voice response ( IVR ) technology , paper questionnaire ( PQ ) , personal digital assistant ( PDA ) , or personal computer ( PC ) and a second form by PC , in the same administration .
METHODS	Method equivalence was evaluated through analyses of difference scores , intraclass correlations ( ICCs ) , and convergent/discriminant validity .
RESULTS	In difference score analyses , no significant mode differences were found and all confidence intervals were within the prespecified minimal important difference of 0.2 standard deviation .
RESULTS	Parallel-forms reliabilities were very high ( ICC = 0.85-0 .93 ) .
RESULTS	Only one across-mode ICC was significantly lower than the same-mode ICC .
RESULTS	Tests of validity showed no differential effect by MOA .
RESULTS	Participants preferred screen interface over PQ and IVR .
CONCLUSIONS	We found no statistically or clinically significant differences in score levels or psychometric properties of IVR , PQ , or PDA administration compared with PC .

###24503689
METHODS	Prospective randomized study .
OBJECTIVE	This study aimed to prospectively compare the surgical results of the open - and French-door laminoplasty .
BACKGROUND	Cervical laminoplasty is a common surgical procedure for the treatment of cervical compressive myelopathy .
BACKGROUND	These procedures are primarily classified as either open - or French-door laminoplasties .
BACKGROUND	Only few prospective studies comparing the surgical results of the 2 procedures are available .
METHODS	A total of 92 patients with cervical compressive myelopathy who underwent cervical laminoplasty were prospectively enrolled and randomized into the following 2 groups according to the type of laminoplasty : open-door and French-door groups .
METHODS	A single attending spine surgeon performed all surgical procedures .
METHODS	The following factors were evaluated : surgical duration , blood loss , perioperative complications , neurological assessment using the Japanese Orthopedic Association score , and recovery rate .
METHODS	Radiological evaluations included assessment of the cervical lordotic angle and cervical range of motion .
METHODS	In addition , the ratio of postoperative spinal lamina opening was evaluated by magnetic resonance imaging .
RESULTS	There were no differences in perioperative complications and neurological outcomes between the 2 groups .
RESULTS	The mean reduction in cervical lordotic angle after surgery was significantly greater in the open-door group than the French-door group ( 3.0 vs. 5.6 ) .
RESULTS	Postoperative cervical range of motion significantly decreased in the open-door group than in the French-door group ( 19.3 vs. 26.0 ) .
RESULTS	Postoperative cervical lordotic angle in the extension position significantly diminished in the open-door group than in the French-door group ( 7.9 vs. 14.1 ) .
RESULTS	The ratio of opening of the spinal lamina after surgery was significantly larger in the open-door group than in the French-door group .
CONCLUSIONS	The 2 laminoplasty methods showed almost the same neurological recovery as well as perioperative complications .
CONCLUSIONS	In cases of open-door laminoplasty , postoperative cervical alignment became more kyphotic and cervical range of motion was more restricted than that in French-door laminoplasty cases after surgery .
CONCLUSIONS	French-door laminoplasty is preferable to open-door laminoplasty for postoperative cervical alignments .
METHODS	1 .

###24648359
BACKGROUND	Burnout is a very prevalent type of stress among health professionals .
BACKGROUND	It affects their well-being , performance , and attitude toward patients .
BACKGROUND	This study assessed the effectiveness of a training program for primary health care professionals designed to reduce burnout and mood disturbance , increase empathy , and develop mindfulness .
METHODS	Pragmatic randomized controlled trial with pre - and postintervention measurements of 68 primary health care professionals ( 43 in the intervention and 25 in the control group ) in Spain .
METHODS	The intervention consisted of presentations of clinically relevant topics , mindfulness-based coping strategies , mindfulness practice , yoga , and group discussions ( 8 sessions of 2.5 hours per week plus a 1-day session of 8 hours ) .
METHODS	Outcome measures included the Maslach Burnout Inventory , Profile of Mood States , Jefferson Scale of Physician Empathy , Baer 's Five Facets Mindfulness Questionnaire , and a questionnaire on changes in personal habits and mindfulness practice .
METHODS	Measurements were performed at baseline and after 8 weeks .
RESULTS	The intervention group improved in the 4 scales measured .
RESULTS	The magnitude of the change was large in total mood disturbance ( difference between groups -7.1 ; standardized effect-size [ SES ] 1.15 ) and mindfulness ( difference between groups 11 ; SES 0.9 ) and moderate in the burnout ( difference between groups -7 ; SES 0.74 ) and empathy scales ( difference between groups 5.2 ; SES 0.71 ) .
RESULTS	No significant differences were found in the control group .
CONCLUSIONS	Our study supports the use of mindfulness-based programs as part of continuing professional education to reduce and prevent burnout , promote positive attitudes among health professionals , strengthen patient-provider relationships , and enhance well-being .

###25922903
OBJECTIVE	Anogenital warts are a common disorder associated with significant physical and mental distress and a substantial cause of health care costs .
OBJECTIVE	To assess the efficacy of the topical application of nitric oxide delivered using acidified nitrite .
METHODS	A multicenter , randomized , controlled , dose-ranging clinical trial was conducted in European genitourinary medicine clinics between December 20 , 2001 , and January 14 , 2003 .
METHODS	Analysis was by intent to treat for all individuals initiating therapy .
METHODS	Participants included male and female volunteers older than 18 years with between 2 and 50 external anogenital warts .
METHODS	A total of 299 individuals from 40 centers were randomized to a control arm and a treatment arm that received 3 doses of acidified nitrite applied topically for 12 weeks with an additional 12 weeks of follow-up , with the final follow-up visit on January 14 , 2003 .
METHODS	Placebo nitrite cream and placebo citric acid cream were applied twice daily .
METHODS	Active treatment was divided as low dose ( sodium nitrite , 3 % , with citric acid , 4.5 % , creams applied twice daily ) , middle dose ( sodium nitrite , 6 % , with citric acid , 9 % , creams applied once daily at night , with placebo applied in the morning ) , and high dose ( sodium nitrite , 6 % , with citric acid , 9 % , creams applied twice daily ) .
METHODS	The primary outcome was proportion of patients with complete clinical clearance of target warts ; secondary outcomes were reduction in target wart area and safety .
RESULTS	Complete clinical clearance at 12 weeks occurred in 10 of 74 patients ( 14 % ; 95 % CI , 6 % -21 % ) with placebo ; 11 of 72 ( 15 % ; 95 % CI , 7 % -24 % ) with low-dose treatment ; 17 of 74 ( 23 % ; 95 % CI , 13 % -33 % ) with middle-dose treatment ; and 22 of 70 ( 31 % ; 95 % CI , 21 % -42 % ) with high-dose treatment ( P = .01 ) .
RESULTS	Reduction in target wart area , time to clearance , and patient and investigator assessments supported the superiority of the high-dose therapy vs placebo .
RESULTS	There were no systemic or serious adverse events associated with treatment .
RESULTS	However , there was a dose-related increase in itching , pain , edema , and staining of the anogenital skin associated with the active treatment .
RESULTS	Overall , 21 patients withdrew from active treatment because of adverse events compared with none using placebo .
CONCLUSIONS	Use of sodium nitrite , 6 % , with citric acid , 9 % , twice daily is more effective than placebo in the treatment of anogenital warts .
CONCLUSIONS	Treatment was associated with local irritant adverse effects .
BACKGROUND	clinicaltrials.gov Identifier : NCT02015260 .

###24967410
OBJECTIVE	Noncardiac chest pain ( NCCP ) is seen more frequently in young population and in these patients loss of function is evolving in social and professional areas .
OBJECTIVE	The aim of the study is to evaluate the levels of anxiety and somatic perception in patients with chest pain presenting to cardiology clinic .
METHODS	Fifty-one patients with noncardiac chest pain and 51 healthy controls were included in the study .
METHODS	All participants performed self-report based health anxiety inventory ( HAI ) , somatosensory amplification scale ( SAS ) , and Toronto alexithymia scale ( TAS ) .
RESULTS	The patient group had significantly higher scores on the SAS , HAI-1 , and HAI-T scales compared to controls ( P < 0.001 , P = 0.006 , and P = 0.038 , resp . )
RESULTS	SAS , HAI-1 , and HAI-T scores were significantly higher in female patients than male ( P = 0.002 , 0.036 , and 0.039 , resp . )
RESULTS	There were significant differences in all TAS subscale scores between two groups .
RESULTS	Patients , who had total TAS score more than 50 , also presented higher levels of health anxiety ( P = 0.045 ) .
CONCLUSIONS	Anxiety , somatic symptoms , and the exaggerated sense of bodily sensations are common in patients with NCCP .
CONCLUSIONS	These patients unnecessarily occupy the cardiology outpatient clinics .
CONCLUSIONS	These negative results can be eliminated when consultation-liaison psychiatry evaluates these patients in collaboration with cardiology departments .

###25876339
OBJECTIVE	To compare the differences in the clinical efficacy on Alzheimer 's disease between acupuncture and medicine .
METHODS	One hundred and forty-one patients were randomized into an acupuncture group ( 72 cases ) and a medicine group ( 69 cases ) .
METHODS	In the acupuncture group , the needling technique for benefiting qi , promoting blood circulation , regulating mind and improving intelligence was used at Shenting ( GV 24 ) , Baihui ( GV 20 ) , Fengchi ( GB 20 ) , Wangu ( GB 12 ) , Danzhong ( CV 17 ) , Zhangwan ( CV 12 ) , Qihai ( CV 6 ) , Xuehai ( SP 10 ) and Zusanli ( ST 36 ) .
METHODS	The supplementary acupoints were selected according to the symptoms and physical signs .
METHODS	Acupuncture was given once a day and 6 treatments were required for a week .
METHODS	In the medicine group , the choline sterase inhibitor , donepezil ( aricept ) was prescribed for oral administration , 1 tablet ( 5 mg ) each time , once every night .
METHODS	Four weeks later , the dose was increased to 2 tablets ( 10 mg ) each time .
METHODS	In the two groups , the treatment of 4 weeks made one session and 4 sessions were required .
METHODS	The changes of scores before and after treatment in the minimum mental state examination ( MMSE ) , the activity of daily living scale ( ADL ) , Alzheimer 's disease assessment scale-cognition ( ADAS-cog ) and the digit span ( DS ) were observed .
RESULTS	After treatment , scores of MMSE and DS were increased as compared with those before treatment ( both P < 0.05 ) and scores of ADL and ADAS-cog were reduced as compared with those before treatment .
RESULTS	The score differences in MMSE , ADL , ADAS-cog and DS before and after treatment were significant in the two groups ( all P < 0.01 ) .
CONCLUSIONS	The needling technique for benefiting qi , promoting blood circulation , regulating mind and improving intelligence significantly improves the overall function , cognition and activity of daily life in the patients of Alzheimer 's disease and the efficacy is better than donepezil .

###24946799
OBJECTIVE	There is little evidence available on the use of robot-assisted therapy in subacute stroke patients .
OBJECTIVE	A randomized controlled trial was carried out to evaluate the short-time efficacy of intensive robot-assisted therapy compared to usual physical therapy performed in the early phase after stroke onset .
METHODS	Fifty-three subacute stroke patients at their first-ever stroke were enrolled 307days after the acute event and randomized into two groups , both exposed to standard therapy .
METHODS	Additional 30 sessions of robot-assisted therapy were provided to the Experimental Group .
METHODS	Additional 30 sessions of usual therapy were provided to the Control Group.The following impairment evaluations were performed at the beginning ( T0 ) , after 15 sessions ( T1 ) , and at the end of the treatment ( T2 ) : Fugl-Meyer Assessment Scale ( FM ) , Modified Ashworth Scale-Shoulder ( MAS-S ) , Modified Ashworth Scale-Elbow ( MAS-E ) , Total Passive Range of Motion-Shoulder/Elbow ( pROM ) , and Motricity Index ( MI ) .
RESULTS	Evidence of significant improvements in MAS-S ( p = 0.004 ) , MAS-E ( p = 0.018 ) and pROM ( p < 0.0001 ) was found in the Experimental Group .
RESULTS	Significant improvement was demonstrated in both Experimental and Control Group in FM ( EG : p < 0.0001 , CG : p < 0.0001 ) and MI ( EG : p < 0.0001 , CG : p < 0.0001 ) , with an higher improvement in the Experimental Group .
CONCLUSIONS	Robot-assisted upper limb rehabilitation treatment can contribute to increasing motor recovery in subacute stroke patients .
CONCLUSIONS	Focusing on the early phase of stroke recovery has a high potential impact in clinical practice .

###24668328
BACKGROUND	In advanced gastric cancer ( AGC ) , no globally accepted prognostic scoring system has been developed .
BACKGROUND	Therefore , we explored baseline prognostic factors in Japanese AGC patients using the data from a randomized controlled trial , Japan Clinical Oncology Group ( JCOG ) 9912 , which investigated the efficacy of systemic chemotherapy as a first-line treatment .
METHODS	Prognostic factors and prognostic indices for overall survival were screened and evaluated in patients enrolled in JCOG9912 using the Cox proportional hazard model .
METHODS	The Royal Marsden Hospital prognostic model was also applied to the JCOG9912 trial .
RESULTS	A total of 650 ( 92.3 % ) of the 704 patients randomized in the JCOG9912 trial , for whom complete data were available for multivariate analyses , was included in the present study ( 5-fluorouracil arm , n = 215 ; irinotecan plus cisplatin arm , n = 216 ; S-1 arm , n = 219 ) .
RESULTS	The median survival time ( MST ) for all patients was 11.8 months .
RESULTS	To construct a prognostic index , we selected four risk factors by multivariate analysis : performance status 1 , number of metastatic sites 2 , no prior gastrectomy , and elevated alkaline phosphatase .
RESULTS	MSTs were 17.0 months for patients categorized into the low-risk group , who had zero or one risk factor ( n = 225 ) ; 10.4 months for patients in the moderate-risk group , who had two or three risk factors ( n = 368 ) ; and 5.0 months for patients in the high-risk group , who had all four risk factors ( n = 57 ) .
CONCLUSIONS	In the present study , we propose a new prognostic index for patients with AGC .
CONCLUSIONS	This can be used for more appropriate patient stratification in future clinical trials .

###24834773
BACKGROUND	Treatment of food allergy essentially consists of food avoidance , but immunotherapy with food is emerging as a new therapeutic option .
OBJECTIVE	To evaluate clinical improvement and immunological changes in patients with peach allergy following sublingual immunotherapy ( SLIT ) with a Prup3 quantified peach extract .
METHODS	A randomized , double-blind , placebo-controlled clinical trial with peach SLIT was conducted .
METHODS	We assessed clinical efficacy after 6 months of treatment by means of double-blind , placebo-controlled oral challenges with peach and also evaluated immunological changes ( basophil activation test [ BAT ] and determination of sulphidoleukotriene production ) following stimulation with peach peel and pulp , rPrup3 , rMald 1 , and rMal d 4 stimulation .
METHODS	We also measured specific IgE and IgG4 to Pru p3 .
RESULTS	After 6 months of SLIT ( T6 ) , the active group showed a 3-fold improvement in tolerance to Prup3 and a significant increase in IgE to rPrup3 and in sLT production following stimulation with peach peel and rPrup3 .
RESULTS	There was also a significant increase in BAT results after stimulation with rPrup3 at 1 month of SLIT ( T1 ) .
RESULTS	Statistically significant between-group differences were only observed for BAT with peach peel and pulp at T1 and T6 and for BAT with rPru p3 at T6 .
RESULTS	No changes were observed in BAT with rMal d 1 or rMal d 4 or in IgG4 levels to nPrup3 .
CONCLUSIONS	SLIT with a Pru p 3 quantified peach extract is clinically effective and leads to an increase in basophil activation and sulphidoleukotriene production following stimulation with rPru p3 and peach peel in the first months of treatment .

###24777223
OBJECTIVE	Pharmacogenetics ( PGx ) promises to optimize patient response to therapy .
OBJECTIVE	However , the public 's acceptance of PGx is not well known , notably when this applies to children .
OBJECTIVE	Our objective was to explore perceptions of PGx testing among individuals , who differ from each other by either parental status or educational exposure to PGx , and to explore parents ' views between PGx testing for oneself and PGx testing for their children .
METHODS	An exploratory survey was conducted among parents and other adults .
METHODS	Surveys P and C were completed by parents , survey NP by middle-aged nonparents , and survey MS by medical students .
RESULTS	Proper explanation before PGx testing appeared to be the most important issue to the respondents ( eg , P = 1.55 10 ( -38 ) for survey NP ) .
RESULTS	Respondents who were more knowledgeable about PGx were also more comfortable with PGx testing ( eg , P = 2.53 10 ( -7 ) in case of mild disease ) .
RESULTS	When PGx testing was for one 's child , parents valued their own understanding more than their child 's assent ( P = 1.57 10 ( -17 ) ) .
CONCLUSIONS	The acceptability of PGx testing , either for oneself or for one 's child , seemed to depend on baseline PGx knowledge , but not on parenthood .

###24320560
OBJECTIVE	Dilatation and curettage ( D&C ) is a common day-care procedure in obstetrics and gynecology , with patients discharged after a brief hospital stay on the same day of the surgery .
OBJECTIVE	Although it has a short duration , severe pain occurs during the procedure .
OBJECTIVE	Therefore , this surgical procedure requires an anesthetic to provide adequate analgesia , rapid onset , and rapid recovery .
OBJECTIVE	The main objective of the present study was to compare the analgesic effectiveness and safety of tramadol with those of fentanyl during D&C .
METHODS	The study comprised 100 women with American Society of Anesthesiologists classification I-II who were scheduled for a D&C procedure .
METHODS	Baseline anesthesia was maintained with 1mg/kg propofol , and the patients were then randomly allocated to receive tramadol 1mg/kg ( Group T , n = 50 ) or fentanyl 1g/kg ( Group F , n = 50 ) .
METHODS	Hemodynamic variables , sedation , pain , the Aldrete recovery score , and side-effects were recorded .
RESULTS	SpO levels in Group F in the 5th min and at the end of the procedure were significantly lower than those in Group T ( P = 0.024 and 0.021 , respectively ) .
CONCLUSIONS	Tramadol provides similar analgesic efficacy to fentanyl .
CONCLUSIONS	Furthermore , tramadol may provide better respiratory stability in patients undergoing a D&C procedure .

###26483244
BACKGROUND	Based on current recommendations , 30 + pack-years of smoking are required for eligibility for low-dose CT ( LDCT ) lung cancer screening ; former smokers must have quit within 15 years .
BACKGROUND	We investigated whether current smokers with 20 to 29 pack-years have similar lung cancer risks as eligible former smokers and also whether they have a different demographic profile .
METHODS	The Prostate , Lung , Colorectal , and Ovarian Cancer Screening Trial ( PLCO ) was a randomly assigned screening trial of subjects age 55 to 74 years with chest radiographs ( CXR ) used for lung cancer .
METHODS	Subjects completed a baseline questionnaire containing smoking history questions .
METHODS	Cox proportional hazards models , adjusted for age and sex , were utilized to estimate hazard ratios ( HRs ) for various smoking history groups .
METHODS	Next , we utilized the National Health Interview Survey ( NHIS ) , which inquired about smoking history and race/ethnicity , to analyze the demographic profiles of various high-risk smoking history categories .
METHODS	All statistical tests were two-sided .
RESULTS	The PLCO cohort included 18 114 former and 12 243 current LDCT-eligible smokers , plus 2283 20 - to 29-pack-year current smokers .
RESULTS	The hazard ratio for 20 - to 29-pack-year current smokers compared with eligible ( 30 + pack-year ) former smokers was 1.07 ( 95 % confidence interval [ CI ] = 0.75 to 1.5 ) .
RESULTS	Based on the NHIS , 10 million persons in the United States are currently LDCT eligible ; an additional 1.6 million ( 16 % , 95 % CI = 13.6 % to 19.0 % ) are 20 - to 29-pack-year current smokers .
RESULTS	The percentage increase in eligibles if 20 - to 29-pack-year current smokers were included was substantially greater for women than men ( 22.2 % , 95 % CI = 17.9 % to 26.7 % ; vs 12.2 % , 95 % CI = 9.3 % to 15.3 % , P < .001 ) and for minorities than non-Hispanic whites ( 30.0 % , 95 % CI = 24.2 % to 36.0 % ; vs 14.1 % , 95 % CI = 11.1 % to 17.0 % , P < .001 ) .
CONCLUSIONS	The potential benefits and harms of recommending LDCT screening for 20 to 29-pack-year current smokers should be assessed .

###25624432
OBJECTIVE	Progression-free survival ( PFS ) in metastatic castration-resistant prostate cancer ( mCRPC ) trials has been inconsistently defined and poorly associated with overall survival ( OS ) .
OBJECTIVE	A reproducible quantitative definition of radiographic PFS ( rPFS ) was tested for association with a coprimary end point of OS in a randomized trial of abiraterone in patients with mCRPC .
METHODS	rPFS was defined as two new lesions on an 8-week bone scan plus two additional lesions on a confirmatory scan , two new confirmed lesions on any scan 12 weeks after random assignment , and/or progression in nodes or viscera on cross-sectional imaging , or death .
METHODS	rPFS was assessed by independent review at 15 % of deaths and by investigator review at 15 % and 40 % of deaths .
METHODS	rPFS and OS association was evaluated by Spearman 's correlation .
RESULTS	A total of 1,088 patients were randomly assigned to abiraterone plus prednisone or prednisone alone .
RESULTS	At first interim analysis , the hazard ratio ( HR ) by independent review was 0.43 ( 95 % CI , 0.35 to 0.52 ; P < .001 ; abiraterone plus prednisone : median rPFS , not estimable ; prednisone : median rPFS , 8.3 months ) .
RESULTS	Similar HRs were obtained by investigator review at the first two interim analyses ( HR , 0.49 ; 95 % CI , 0.41 to 0.60 ; P < .001 and HR , 0.53 ; 95 % CI , 0.45 to 0.62 ; P < .001 , respectively ) , validating the imaging data assay used .
RESULTS	Spearman 's correlation coefficient between rPFS and OS was 0.72 .
CONCLUSIONS	rPFS was highly consistent and highly associated with OS , providing initial prospective evidence on further developing rPFS as an intermediate end point in mCRPC trials .

###24990004
BACKGROUND	Rehabilitation care is an important part of comprehensive care for MS patients .
BACKGROUND	Little is known about the number of physiatry residents who are interested in providing care to individuals with multiple sclerosis [ MS ] .
OBJECTIVE	This study examines factors that influence physiatry residents ' interest in providing care to MS patients .
METHODS	We randomly sampled half of all Accreditation Council for Graduate Medical Education-certified physical medicine and rehabilitation residency programs in the continental United States and Puerto Rico .
METHODS	Surveys were received from 74 % of programs ( Stage 1 response rate ) and from 221 residents ( 45 % Stage 2 response rate ) .
RESULTS	Residents expressing interest in providing MS care were more likely to be female , Asian , and to select statements emphasizing multidisciplinary care approaches and a community of dedicated professional colleagues as positive features of MS patient care .
RESULTS	Residents interested in teaching and with more education debt were marginally more likely to express interest in MS care .
CONCLUSIONS	Medical education should emphasize the need for physical medicine and rehabilitative care among individuals with MS , the ability of physiatrists to improve the functional status and quality of life for MS patients , and the team-based nature of MS care .

###25761501
BACKGROUND	Lysine requirements of well-nourished children from developing regions have been found to be similar to those of children from developed regions ( 33.5 mgkgd ) .
BACKGROUND	However , intestinal parasites have been shown to increase lysine requirements in undernourished adults , and it is not known if a similar phenomenon occurs in undernourished children from poor and unsanitary environments .
OBJECTIVE	Our objective was to measure the lysine requirement of moderately undernourished school-aged Indian children by the indicator amino acid oxidation technique before and after successful treatment for intestinal parasites .
METHODS	Twenty-one undernourished school-aged children ( 8 y of age ) with z scores between -2 SD and -3 SD for height-for-age or weight-for-age , who tested positive for intestinal parasites , were studied before and after successful antiparasite treatment .
METHODS	Children were fed any 2 of 7 levels of lysine intakes ( 5 , 15 , 25 , 35 , 50 , 65 , and 80 mgkgd ) in random order .
METHODS	The lysine requirement was determined by applying a 2-phase linear regression crossover analysis on the fractional oxidation rate of the tracer L - [ 1-C ] phenylalanine in response to the graded lysine intakes .
RESULTS	The lysine requirement of undernourished children with intestinal parasite infestations was determined to be 42.8 mgkgd ( 95 % CI : 32.6 , 53.1 mgkgd ) , and after successful antiparasitic treatment it was determined to be 35.5 mgkgd ( 95 % CI : 25.5 , 45.5 mgkgd ) .
RESULTS	The results were significantly different ( P < 0.05 ) , although the 95 % CIs overlapped .
CONCLUSIONS	The lysine requirement in undernourished children is similar to that of well-nourished children , and intestinal parasitic infestation increased the lysine requirement by 20 % .

###24259978
OBJECTIVE	To compare the efficacy and side effects of low-dose amitriptyline ( AMT ) with proton pump inhibitor treatment in patients with globus pharyngeus .
METHODS	Thirty-four patients who fulfilled the Rome III criteria for functional esophageal disorders were included in this study .
METHODS	Patients were randomly assigned to receive either 25 mg AMT before bedtime ( AMT group ) or 40 mg Pantoprazole once daily for 4 wk ( conventional group ) .
METHODS	The main efficacy endpoint was assessed using the Glasgow Edinburgh Throat Scale ( GETS ) .
METHODS	The secondary efficacy endpoints included the Medical Outcomes Study 36-item short form health survey [ social functioning ( SF ) -36 ] and the Pittsburgh Sleep Quality Index .
METHODS	Treatment response was defined as a > 50 % reduction in GETS scores .
METHODS	All patients entering this study recorded side effects at days 1 , 8 , 15 , 22 and 29 using a visual analogue scale .
RESULTS	Thirty patients completed the study .
RESULTS	After 4 wk of treatment , the AMT group had a greater response than the conventional group ( 75 % vs 35.7 % , P = 0.004 ) .
RESULTS	At day 3 , the AMT group showed significantly more improvement than the Conventional group in GETS score ( 3.69 1.14 vs 5.64 1.28 , P = 0.000 ) .
RESULTS	After 4 wk of treatment , the AMT group showed significantly greater improvement in GETS score and sleep quality than the Conventional group ( 1.25 1.84 vs 3.79 2.33 , 4.19 2.07 vs 8.5 4.97 ; P < 0.01 for both ) .
RESULTS	Additionally , the AMT group was more likely than the Conventional group to experience improvement in the SF-36 , including general health , vitality , social functioning and mental health ( P = 0.044 , 0.024 , 0.049 and 0.005 ) .
RESULTS	Dry mouth , sleepiness , dizziness and constipation were the most common side effects .
CONCLUSIONS	Low-dose AMT is well tolerated and can significantly improve patient symptoms , sleep and quality of life .
CONCLUSIONS	Thus , low-dose AMT may be an effective treatment for globus pharyngeus .

###25817373
BACKGROUND	Up to now , all tested Ebola virus vaccines have been based on the virus strain from the Zaire outbreak in 1976 .
BACKGROUND	We aimed to assess the safety and immunogenicity of a novel recombinant adenovirus type-5 vector-based Ebola vaccine expressing the glycoprotein of the 2014 epidemic strain .
METHODS	We did this randomised , double-blind , placebo-controlled , phase 1 clinical trial at one site in Taizhou County , Jiangsu Province , China .
METHODS	Healthy adults ( aged 18-60 years ) were sequentially enrolled and randomly assigned ( 2:1 ) , by computer-generated block randomisation ( block size of six ) , to receive placebo , low-dose adenovirus type-5 vector-based Ebola vaccine , or high-dose vaccine .
METHODS	Randomisation was pre-stratified by dose group .
METHODS	All participants , investigators , and laboratory staff were masked to treatment allocation .
METHODS	The primary safety endpoint was occurrence of solicited adverse reactions within 7 days of vaccination .
METHODS	The primary immunogenicity endpoints were glycoprotein-specific antibody titres and T-cell responses at day 28 after the vaccination .
METHODS	Analysis was by intention to treat .
METHODS	The study is registered with ClinicalTrials.gov , number NCT02326194 .
RESULTS	Between Dec 28 , 2014 , and Jan 9 , 2015 , 120 participants were enrolled and randomly assigned to receive placebo ( n = 40 ) , low-dose vaccine ( n = 40 ) , or high-dose vaccine .
RESULTS	Participants were followed up for 28 days .
RESULTS	Overall , 82 ( 68 % ) participants reported at least one solicited adverse reaction within 7 days of vaccination ( n = 19 in the placebo group vs n = 27 in the low-dose group vs n = 36 in the high-dose group ; p = 00002 ) .
RESULTS	The most common reaction was mild pain at the injection site , which was reported in eight ( 20 % ) participants in the placebo group , 14 ( 35 % ) participants in the low-dose group , and 29 ( 73 % ) participants in the high-dose vaccine group ( p < 00001 ) .
RESULTS	We recorded no statistical differences in other adverse reactions and laboratory tests across groups .
RESULTS	Glycoprotein-specific antibody titres were significantly increased in participants in the low-dose and high-dose vaccine groups at both day 14 ( geometric mean titre 4214 [ 95 % CI 2497-7113 ] and 8205 [ 5989-11240 ] , respectively ; p < 00001 ) and day 28 ( 6827 [ 4243-10985 ] and 13057 [ 9701-17572 ] , respectively ; p < 00001 ) .
RESULTS	T-cell responses peaked at day 14 at a median of 4650 spot-forming cells ( IQR 1800-12025 ) in participants in the low-dose group and 7650 cells ( 4000-14600 ) in those in the high-dose group .
RESULTS	21 ( 18 % ) participants had mild fever ( n = 9 in the placebo group , n = 6 in the low-dose group , and n = 6 in the high-dose group ) .
RESULTS	No serious adverse events were recorded .
CONCLUSIONS	Our findings show that the high-dose vaccine is safe and robustly immunogenic .
CONCLUSIONS	One shot of the high-dose vaccine could mount glycoprotein-specific humoral and T-cell response against Ebola virus in 14 days .
BACKGROUND	China National Science and Technology , Beijing Institute of Biotechnology , and Tianjin CanSino Biotechnology .

###25061700
OBJECTIVE	To evaluate the thermal antinociceptive effects and duration of action of buprenorphine hydrochloride after IM administration to American kestrels ( Falco sparverius ) .
METHODS	12 healthy 3-year-old American kestrels .
METHODS	Buprenorphine hydrochloride ( 0.1 , 0.3 , and 0.6 mg/kg ) and a control treatment ( saline [ 0.9 % NaCl ] solution ) were administered IM in a randomized crossover experimental design .
METHODS	Foot withdrawal response to a thermal stimulus was determined 1 hour before ( baseline ) and 1.5 , 3 , and 6 hours after treatment administration .
METHODS	Agitation-sedation scores were determined 3 to 5 minutes before each thermal stimulus .
METHODS	Adverse effects were monitored for 6 hours after treatment administration .
RESULTS	Buprenorphine hydrochloride at 0.1 , 0.3 , and 0.6 mg/kg , IM , increased thermal threshold for 6 hours , compared with the response for the control treatment .
RESULTS	There were no significant differences among buprenorphine treatments .
RESULTS	A mild sedative effect was detected at a dose of 0.6 mg of buprenorphine/kg .
CONCLUSIONS	At the doses tested , buprenorphine hydrochloride resulted in thermal antinociception in American kestrels for at least 6 hours , which suggested that buprenorphine has analgesic effects in this species .
CONCLUSIONS	Further studies with longer evaluation periods and additional forms of noxious stimuli , formulations , dosages , and routes of administration are needed to fully evaluate the analgesic effects of buprenorphine in American kestrels .

###24884455
BACKGROUND	Patellofemoral pain syndrome ( PFPS ) is a common musculoskeletal condition , particularly among women .
BACKGROUND	Patients with PFPS usually experience weakness in the gluteal muscles , as well as pain and impaired motor control during activities of daily living .
BACKGROUND	Strengthening the hip muscles is an effective way of treating this disorder .
BACKGROUND	Neuromuscular training has also been identified as a therapeutic tool , although the benefits of this intervention in patients with PFPS patients remain inconclusive .
METHODS	This is a protocol of randomized controlled trial with a blind assessor .
METHODS	Thirty-four women with a clinical diagnosis of PFPS participated .
METHODS	These participants were allocated into two groups ( experimental and control ) .
METHODS	The experimental group performed twelve sessions to strengthen the knee extensors , hip abductor and lateral rotator muscles in association with neuromuscular training of the trunk and lower extremities .
METHODS	The control group performed the same number of sessions to strengthen the muscles of the hip and knee .
METHODS	The primary outcome was functional capacity ( Anterior Knee Pain Scale - AKPS ) at 4weeks .
METHODS	Pain intensity , muscle strength and kinematic changes were also measured during the step down test after four weeks of intervention .
METHODS	Follow up assessments were conducted after three and six months to assess functional capacity and pain .
METHODS	The effects of the treatment ( i.e. between-group differences ) were calculated using mixed linear models .
CONCLUSIONS	The present study was initiated on the 1st of April 2013 and is currently in progress .
CONCLUSIONS	The results of this study may introduce another effective technique of conservative treatment and could guide physical therapists in the clinical decision-making process for women with PFPS .
BACKGROUND	Current Controlled Trials NCT01804608 .

###24738317
OBJECTIVE	The objective of this study was to evaluate the effect of nasal packing , septal suture technique and vacuum sealing drainage ( VSD ) after septoplasty .
METHODS	Ninety patients of nasal septal deviation in Combination with outfracture of the inferior turbinates who had received septoplasty were selected in this study .
METHODS	The patients were allocated into three groups , with thirty in each : for packing group , marcel materials were used for nasal packing after septoplasty ; for suturing group , septal suture technique was performed after septoplasty ; for VSD group , one drainage tube was used for negative pressure sucking after septoplasty without nasal packing .
METHODS	Postoperative signs and symptoms were compared between three groups .
METHODS	The comfort degree assessment included headache and nasal obstruction were evaluated by using visual analogue scale ( VAS ) at the 12th hour and 24 hour after operation .
METHODS	The edema in nasal cavity , hemorrhage .
METHODS	abscess , adhesive and healing rates after operation were compared among three groups .
RESULTS	The VAS score of headache and nasal obstruction and the severity of patient 's conditions were significantly less in septal suture group and VSD group than that in packing group at the 12th and 24th hour after operation .
RESULTS	The mucosa edema of nasal cavity was significantly slighter in septal suture group and VSD group than that in packing group at the third day after operation .
RESULTS	The healing rates and number of complications are better in septal suture group and VSD group than those in packing group at the 7th day after operation .
RESULTS	There were no hemorrhage or abscess in VSD group .
CONCLUSIONS	Septal suture technique and VSD after septoplasty can significantly relieve the distress of patients and reduce the healing time of mucosa in nasal cavity without increasing the risk of complications .

###25870079
OBJECTIVE	To investigate baseline predictors of month 24 best-corrected visual acuity ( BCVA ) and central foveal thickness ( CFT ) in patients with diabetic macular edema ( DME ) treated monthly with ranibizumab or sham .
METHODS	Post hoc analysis of DME patients in 2 identical phase 3 studies .
METHODS	Patients randomized to ranibizumab ( n = 502 ) or sham ( n = 257 ) .
METHODS	Multivariate regression on predictors with P < 0.20 in univariate logistic regression using backward selection to retain predictors with P < 0.05 .
METHODS	Patient characteristics correlating with month 24 BCVA in Early Treatment Diabetic Retinopathy Study letter score 70 ( 20/40 ) or 50 ( 20/100 ) , gain or loss from baseline BCVA of 15 , or CFT 250 m.
RESULTS	Baseline predictors of BCVA 20/40 in ranibizumab-treated patients were good BCVA , submacular fluid , no cardiovascular disease , no scatter photocoagulation , and male gender , whereas in sham-treated patients , they were mild increase in CFT , presence of hard exudates in center subfield , and absence of renal disease .
RESULTS	Predictors of improvement in BCVA letter score 15 in ranibizumab-treated patients were poor BCVA , submacular fluid , young age , and short diabetes duration , and those in sham-treated patients were poor BCVA , young age , and mild increase in CFT .
RESULTS	Predictors of resolution of edema ( CFT 250 m ) in ranibizumab-treated patients were mild foveal thickening and prominent subfoveal fluid , and those in sham-treated patients were poor BCVA , mild foveal thickening , and statin usage .
RESULTS	Month 24 BCVA 20/100 was predicted by poor baseline BCVA in ranibizumab-treated patients , and by poor baseline BCVA , large intraretinal cystoid spaces , renal disease , and absence of hypercholesterolemia in sham-treated patients .
RESULTS	Loss of BCVA 15 letters was predicted in sham-treated patients by submacular fluid , intraretinal cystoid spaces , and renal disease .
CONCLUSIONS	Patients with DME and submacular fluid , intraretinal cysts , severe thickening , or renal disease respond poorly when untreated and respond well to ranibizumab treatment .
CONCLUSIONS	Elimination of submacular fluid , intraretinal cysts , and severe thickening are important goals of DME treatment , and in patients with renal disease , treatment should be very aggressive , with a goal of eliminating all macular fluid .

###24488743
OBJECTIVE	This study included 54-month-old children with a history of institutional care .
OBJECTIVE	Our goal was to : ( 1 ) examine differences in indiscriminate social behaviors in children with a history of institutional care compared with home-reared children ; ( 2 ) test whether foster care reduces indiscriminate social behaviors in a randomized controlled trial ; and ( 3 ) examine early predictors of indiscriminate behaviors .
METHODS	Participants were 58 children with a history of institutional care and 31 never-institutionalized control ( NIG ) subjects enrolled in a randomized controlled trial of foster care for institutional care , assessed from toddlerhood to 54 months .
METHODS	Indiscriminate social behaviors were measured naturalistically by using the Stranger at the Door procedure .
RESULTS	In the Stranger at the Door procedure , children with a history of institutional care left with a stranger at higher rates than NIG subjects ( 33 % vs. 3.5 % ; P < .001 ) .
RESULTS	Children in the care as usual group left more than NIG subjects ( 41.9 % vs. 3.6 % ; P .001 ) .
RESULTS	The differences between the foster care group ( 24.1 % ) and the care as usual group and between foster care group and NIG were not significant .
RESULTS	In a logistic regression , early disorganized attachment behaviors , baseline developmental quotient , and caregiving quality after randomization contributed to variance at 54 months .
RESULTS	In the same analysis using only children with a history of institutional care , only disorganized attachment contributed significantly to 54-month indiscriminate social behaviors ( Exp [ B ] = 1.6 [ 95 % confidence interval : 1.1-2 .5 ] ) .
CONCLUSIONS	Observed socially indiscriminate behaviors at 54 months were associated with prolonged exposure to institutional care .
CONCLUSIONS	Young children raised in conditions of deprivation who fail to develop organized attachments as toddlers are at increased risk for subsequent indiscriminate behaviors .

###25840499
BACKGROUND	One goal of guideline-based asthma therapy is minimal use of short-acting agonist ( SABA ) medications .
BACKGROUND	Inner-city children with asthma are known to have high SABA use .
OBJECTIVE	To examine factors associated with high SABA use in inner-city children with asthma .
METHODS	One hundred inner-city children with persistent asthma were enrolled into a randomized controlled trial of an emergency department ( ED ) and home intervention .
METHODS	All children underwent serologic allergen specific IgE and salivary cotinine testing at the ED enrollment visit .
METHODS	Pharmacy records for the past 12 months were obtained .
METHODS	Number of SABA fills during the past 12 months was categorized into low - to moderate - vs high-use groups .
METHODS	SABA groups were compared by the number of symptom days and nights , allergen sensitization , and exposures .
METHODS	Regression models were used to predict high SABA use .
RESULTS	Mean number of SABA fills over 12 months was 3.12 .
RESULTS	Unadjusted bivariate analysis showed that high SABA users were more than 5 times more likely to have an asthma hospitalization , almost 3 times more likely to have an asthma intensive care unit admission , and more than 3 times more likely to have prior specialty asthma care or positive cockroach sensitization than low to moderate SABA users .
RESULTS	In the final regression model , for every additional inhaled corticosteroid fill , a child was 1.4 times more likely and a child with positive cockroach sensitization was almost 7 times more likely to have high SABA use when controlling for prior intensive care unit admission , receipt of specialty care , child age , and income .
CONCLUSIONS	Providers should closely monitor SABA and controller medication use , allergen sensitization , and exposures in children with persistent asthma .
BACKGROUND	ClinicalTrials.gov , identifier NCT01981564 .

###24674053
OBJECTIVE	To compare the cardiopulmonary effects of intravenous ( IV ) and intramuscular ( IM ) medetomidine and butorphanol with or without MK-467 .
METHODS	Prospective , randomized experimental cross-over .
METHODS	Eight purpose-bred beagles ( two females , six males ) , 3-4 years old and weighing 14.5 1.6 kg ( mean SD ) .
METHODS	All dogs received four different treatments as follows : medetomidine 20 g kg ( -1 ) and butorphanol tartrate 0.1 mg kg ( -1 ) IV and IM ( MB ) , and MB combined with MK-467 ,500 g kg ( -1 ) ( MBMK ) IV and IM .
METHODS	Heart rate ( HR ) , arterial blood pressures ( SAP , MAP , DAP ) , central venous pressure ( CVP ) , cardiac output , respiratory rate ( fR ) , rectal temperature ( RT ) were measured and arterial blood samples were obtained for gas analysis at baseline and at 3 , 10 , 20 , 30 , 45 and 60 minutes after drug administration .
METHODS	The cardiac index ( CI ) , systemic vascular resistance index ( SVRI ) and oxygen delivery index ( DO2 I ) were calculated .
METHODS	After the follow-up period atipamezole 50 g kg ( -1 ) IM was given to reverse sedation .
RESULTS	HR , CI and DO2 I were significantly higher with MBMK after both IV and IM administration .
RESULTS	Similarly , SAP , MAP , DAP , CVP , SVRI and RT were significantly lower after MBMK than with MB .
RESULTS	There were no differences in fR between treatments , but arterial partial pressure of oxygen decreased transiently after all treatments .
RESULTS	Recoveries were uneventful following atipamezole administration after all treatments .
CONCLUSIONS	MK-467 attenuated the cardiovascular effects of a medetomidine-butorphanol combination after IV and IM administration .

###25011657
OBJECTIVE	To evaluate adherence to therapy in acne patients using mobile phones and Short Message Service ( SMS ) to communicate .
METHODS	160 patients were randomly assigned to two groups : the SMS group received 2 text messages twice a day for a period of 12 weeks ; the control group did not receive any messages .
METHODS	Before and after 12 weeks , the following evaluations were performed in all patients : digital photographs , the Global Acne Grading System , the Dermatology Life Quality Index , the Cardiff Acne Disability Index , the doctor-patient relationship evaluated through the Patient-Doctor Depth-of-Relationship Scale , and the adherence to treatment evaluated by asking patients how many days a week they had followed the therapy .
METHODS	For statistical analysis we used Student 's t test .
RESULTS	The SMS group had a better improvement of all parameters compared to the control group .
CONCLUSIONS	Adherence and compliance are higher for patients who are included in a strategy of control .

###24440809
BACKGROUND	Ondansetron , sometimes combined with acustimulation at PC6 ( Neiguan ) , is commonly used for preventing postoperative nausea and vomiting , but PC6 is not the only point that can be used for this purpose .
OBJECTIVE	To evaluate the combined effects of ondansetron and ST36 ( Zusanli ) acupuncture point injection on postoperative vomiting ( POV ) after laparoscopic surgery .
METHODS	A randomised , patient and assessor-blinded , placebo-controlled clinical study was conducted .
METHODS	One hundred and sixty patients undergoing laparoscopic surgery were randomly assigned to one of four groups : ( 1 ) group P ( placebo-control ) : intravenous normal saline + bilateral non-acupuncture point injection of vitamin B1 ( n = 40 ) ; ( 2 ) group O ( ondansetron ) : intravenous ondansetron + bilateral ST36 sham injection ( n = 40 ) ; ( 3 ) group A ( acupuncture point injection ) : intravenous normal saline + bilateral acupuncture point injection at ST36 of vitamin B1 ( n = 40 ) ; ( 4 ) group C ( combination ) : intravenous ondansetron + bilateral acupuncture point injection at ST36 of vitamin B1 ( n = 40 ) .
METHODS	Interventions were made on arrival at the postanaesthesia care unit .
METHODS	The primary outcome was the incidence of POV within 24 h after the operation .
METHODS	Secondary outcomes included severity of vomiting , incidence of rescue treatment , patients ' satisfaction and the first anal exsufflation time 24 h after the operation .
RESULTS	The incidence of POV within 24 h postoperative period in each group was P 33 % ; O 11 % , A 9 % and C 6 % .
RESULTS	Outcomes for all intervention groups were significantly better than that for placebo ( p < 0.01 ) .
RESULTS	For the three interventions compared with placebo , the numbers needed to treat ( NNTs ) were O , NNT = 5 ; A , NNT = 5 and C , NNT = 4 .
RESULTS	The secondary outcomes also demonstrated greater benefits of the combined regimen , with improvement seen in all the measures .
CONCLUSIONS	Ondansetron , acupuncture , and ondansetron and acupuncture combined are effective prophylaxis for POV .

###24601726
BACKGROUND	The impact of sugar-sweetened beverages ( SSB ) on lipid metabolism when consumed in moderate amounts by normal weight subjects is debated .
OBJECTIVE	The objective of the study was to investigate the effect of different types of sugars in SSB on fatty acid metabolism ( ie , fatty acid synthesis and oxidation ) in healthy young men .
METHODS	Thirty-four normal-weight men were studied in a randomized crossover study .
METHODS	Four isocaloric 3-week interventions with SSB were performed in random order : medium fructose ( MF ; 40 g/d ) ; high fructose ( HF ; 80 g/d ) , high sucrose ( HS ; 80 g/d ) , and high glucose ( HG ; 80g/d ) .
METHODS	Fasting total plasma fatty acid composition was measured after each intervention .
METHODS	Acylcarnitines were measured in the fasting state and after a euglycemic hyperinsulinemic clamp in nine subjects .
RESULTS	The relative abundance of palmitate ( 16:0 ) and the molar fatty acid ratio of palmitate to linoleic acid ( 16:0 to18 :2 ) as markers of fatty acid synthesis were increased after HF [ relative abundance of palmitate : 22.97 % 5.51 % ( percentage of total fatty acids by weight SD ) ] and MF ( 26.1 % 1.7 % ) compared with HS ( 19.40 % 2.91 % , P < .001 ) , HG ( 19.43 % 3.12 % , P < .001 ) , or baseline ( 19.40 % 2.79 % , P < .001 ) .
RESULTS	After HS and HG , the relative abundance of palmitate was equal to baseline .
RESULTS	Fasting palmitoylcarnitine was significantly increased after HF and HS ( HF and HS vs. HG : P = .005 ) , decreasing after inhibition of lipolysis by insulin in the clamp .
CONCLUSIONS	When consumed in moderate amounts , fructose but not sucrose or glucose in SSB increases fatty acid synthesis ( palmitate ) , whereas fasting long-chain acylcarnitines are increased after both fructose and sucrose , indicating an impaired - oxidation flux .

###25465830
BACKGROUND	Little is known about global patterns of critical care unit ( CCU ) care and the relationship with outcomes in patients with acute decompensated heart failure ( ADHF ) .
BACKGROUND	Whether a ward or a CCU admission is associated with better outcomes is unclear .
METHODS	Patients in the Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure ( ASCEND-HF ) trial were initially hospitalized in a ward or CCU ( coronary or intensive care unit ) .
METHODS	Sites were geographically classified : Asia-Pacific ( AP ) , Central Europe ( CE ) , Latin America ( LA ) , North America ( NA ) , and Western-Europe ( WE ) .
METHODS	The primary outcome of 30-day all-cause mortality or all-cause hospital readmission was adjusted using a two-stage multivariable logistic regression model with a generalized estimated equation that took sites within each country as a nested random factor .
RESULTS	Overall , 1944 ( 38.2 % ) patients were admitted to a CCU and 3150 ( 61.8 % ) to a ward , and this varied by region : 50.6 % AP , 63.3 % CE , 60.7 % WE , 22.1 % LA , and 28.6 % NA .
RESULTS	The 30-day death or readmission rate was 15.2 % in ward patients and 17.0 % in CCU patients ( risk-adjusted Odds Ratio [ OR ] 1.44 : 95 % CI , 1.14-1 .82 ) .
RESULTS	Compared with CCU patients in NA ( 24.1 % 30-day event rate ) , the primary outcomes were : AP ( 10.4 % , Odds Ratio [ OR ] 0.63 ; 95 % confidence Interval [ CI ] , 0.35 to 1.15 ) , CE ( 10.4 % , OR 0.56 : 95 % CI , 0.31 to 1.02 ) , LA ( 22.4 % , OR 0.60 : 95 % CI , 0.11 to 3.32 ) , and WE ( 11.2 % , OR 0.63 , 95 % CI , 0.25 to 1.56 ) .
RESULTS	No regional differences in 30-day mortality were observed ; however , 30-day readmission rates were highest in NA sites .
CONCLUSIONS	Management of patients with ADHF varies significantly , and after adjustment , CCU care was associated with higher risk of early mortality , not explained by international differences .
CONCLUSIONS	These findings may help to improve the early decisions regarding risk stratification of patients hospitalized with ADHF .

###26124485
OBJECTIVE	Hand-foot syndrome ( HFS ) is a frequently occurring adverse event associated with anticancer drugs .
OBJECTIVE	This study compares a newly introduced ointment containing several antioxidants and exhibiting high radical protection factor , which has been available on the German market since 2011 , with urea cream for prevention of HFS in patients treated with capecitabine .
METHODS	Patients with GI tumors or breast cancer treated with capecitabine were included in this randomized phase III study .
METHODS	The primary end point was prevention of HFS of any grade within 6 weeks of treatment as indicated by a standardized patient diary .
METHODS	The study had 80 % power to show a 20 % reduction of the incidence of HFS with the new ointment .
METHODS	Secondary end points included time to development of HFS greater than grade 1 , evaluation of capecitabine dose intensity , and quality of life analyses .
RESULTS	A total of 152 patients were evaluable .
RESULTS	In total , 47 of 152 patients experienced HFS ( 30.9 % ) , 39.5 % with the new ointment and 22.4 % in the urea arm ( stratified odds ratio , 2.37 ; P = .02 ) .
RESULTS	Time to HFS greater than grade 1 was comparable , but time to any-grade HFS was significantly longer in the urea group ( P = .03 ) .
RESULTS	Capecitabine dose intensity , time under study , and percentage of days with correct administration of study medication were identical , as were adverse events except for HFS .
RESULTS	Skin-related quality of life was significantly worse in the group treated with the new ointment at the end of study treatment .
CONCLUSIONS	This trial demonstrated that 10 % urea cream was superior to the new ointment at preventing HFS over the first 6 weeks of treatment with capecitabine .

###25225241
BACKGROUND	Atrial fibrillation ( AFib ) is common in heart failure ( HF ) with preserved ejection fraction ( HFpEF ) .
BACKGROUND	Current AFib stroke risk prediction models include the presence of HF but do not specifically include HFpEF as a risk factor .
BACKGROUND	Whether a history of AFib should be used to identify patients with HFpEF who are at risk has not been established .
RESULTS	Baseline characteristics and outcomes of patients with HFpEF in the Irbesartan in Heart Failure with Preserved Ejection Fraction Trial were analyzed in relation to AFib .
RESULTS	At baseline , 1209 ( 29.3 % ) had a history of AFib .
RESULTS	Of these 557 ( 13.5 % ) had history of AFib alone , whereas 670 ( 16.2 % ) had both a history and AFib on ECG ; 2901 ( 70.3 % ) had neither .
RESULTS	There were no significant differences in the risk of stroke between the 2 groups with a history of AFib who did or did not have AFib present on baseline ECG .
RESULTS	During a median follow-up of 53 months , a fatal or nonfatal stroke occurred in 6.5 % ( 79/1209 ) patients with history of AFib compared with 3.9 % ( 114/2901 ) with no AFib .
RESULTS	Having a history of AFib was independently associated with higher risk of stroke ( hazard ratio , 2.2 ; 95 % confidence interval , 1.6-3 .2 ; P < 0.0001 ) compared with those with no history of AFib .
CONCLUSIONS	In patients with HFpEF , a history of AFib was common and independently associated with increased risk of stroke , regardless of whether AFib was present on ECG .
CONCLUSIONS	Patients with HFpEF and a history of AFib should be considered at risk .
CONCLUSIONS	Further studies are needed to determine whether this risk can be safely reduced .
BACKGROUND	http://www.clinicaltrials.gov .
BACKGROUND	Unique identifier : NCT000095238 .

###25637376
BACKGROUND	Selective kappa opioid receptor antagonism is a promising experimental strategy for the treatment of depression .
BACKGROUND	The kappa opioid receptor antagonist , LY2456302 , exhibits ~ 30-fold higher affinity for kappa opioid receptors over mu opioid receptors , which is the next closest identified pharmacology .
METHODS	Here , we determined kappa opioid receptor pharmacological selectivity of LY2456302 by assessing mu opioid receptor antagonism using translational pupillometry in rats and humans .
RESULTS	In rats , morphine-induced mydriasis was completely blocked by the nonselective opioid receptor antagonist naloxone ( 3mg/kg , which produced 90 % mu opioid receptor occupancy ) , while 100 and 300 mg/kg LY2456302 ( which produced 56 % and 87 % mu opioid receptor occupancy , respectively ) only partially blocked morphine-induced mydriasis .
RESULTS	In humans , fentanyl-induced miosis was completely blocked by 50mg naltrexone , and LY2456302 dose-dependently blocked miosis at 25 and 60 mg ( minimal-to-no blockade at 4-10mg ) .
CONCLUSIONS	We demonstrate , for the first time , the use of translational pupillometry in the context of receptor occupancy to identify a clinical dose of LY2456302 achieving maximal kappa opioid receptor occupancy without evidence of significant mu receptor antagonism .

###24992750
OBJECTIVE	To compare the efficacy of an acupuncture regimen for persistent allergic rhinitis ( PER ) , aimed at improving a patient 's mind or Shen in Traditional Chinese Medicine , to that of a second-generation Hi-receptor antagonist , cetirizine hydrochloride .
METHODS	This multicenter , randomized , controlled clinical trial on PER will be conducted at three institutions in China .
METHODS	The total study period will be 9 weeks .
METHODS	After a 1-week preparatory screening period , 240 eligible participants with PER will be randomized to receive acupuncture or pharmacotherapy ( 1:1 ) for 4 weeks with a 4-week follow-up .
METHODS	The primary outcome will be changes in 7-day average total nasal symptom score .
METHODS	Secondary outcome measures include rhinoconjunctivitis quality of life questionnaire score and total non-nasal symptom score .
RESULTS	The presence and seriousness of psychological and emotional impairments should be considered in therapeutic programs for allergic rhinitis .
RESULTS	No clinical trial for treating allergic rhinitis via acupuncture regulation of psychological and emotional activities has been reported .
CONCLUSIONS	The findings of the trial will allow us to determine the effects of the mind ( Shen ) - regulation treatment approach .
CONCLUSIONS	We will also be able to confirm if the effects of acupuncture are equivalent to those of the conventional drug cetirizine hydrochloride .

###25516315
BACKGROUND	Probiotics are microbial supplements that have shown efficacy in a wide range of applications .
BACKGROUND	To assess the safety and effects of enteral probiotics in critically ill neonates .
METHODS	A double-blind , randomized controlled trial was conducted in 100 full-term infants with critical illness according to scores of neonatal acute physiology .
METHODS	Fifty neonatal intensive care patients were randomly assigned to receive probiotics three times daily after birth for 8 days , and fifty patients were not given probiotics , but who received a placebo .
METHODS	The incidence of sepsis , multiple organ dysfunction syndrome ( MODS ) , nosocomial pneumonia , and necrotizing enterocolitis were recorded .
METHODS	The prognosis of probiotic treatment was determined based on the rate of recovery and hospital days .
METHODS	Serum IgA , IgG , and IgM concentrations were measured on days 4 and 8 .
RESULTS	Infants in the probiotics group showed a significantly reduced rate of nosocomial pneumonia ( 18 % versus 36 % ) and multiple organ dysfunction syndrome ( 6 % versus 16 % ) compared with the placebo group ( p < 0.05 ) .
RESULTS	Significant results were demonstrated in favour of the probiotics for days of hospital stay ( 13 3.5 d versus 15.8 5.3 d ) ( p < 0.05 ) .
RESULTS	However , there were no significant differences in the occurrence of sepsis , necrotizing enterocolitis , and recovery rate .
RESULTS	Patients given probiotics had significantly greater levels of IgA than those in the placebo group ( p < 0.05 ) .
RESULTS	No serious adverse effects in the study population were noted .
CONCLUSIONS	Supplements of probiotics to critically ill neonates could enhance immune activity , decrease occurrence of nosocomial pneumonia and MODS , and reduce days in hospital .

###24275612
BACKGROUND	Recently , there have been investigations that have targeted improving the relatively poor validity and reliability of attentional bias measures .
BACKGROUND	These studies have demonstrated that individuals show elevated attentional bias to stimuli associated with their drinking history , although to date , the predictive utility of these measures has yet to be assessed .
BACKGROUND	The current study aimed to investigate the predictive value of an individualised alcohol Stroop task compared to that of an alcohol Stroop task with general alcohol-related words in a sample of non-dependent undergraduate drinkers .
METHODS	48 undergraduate social drinkers completed questionnaire measures of alcohol consumption and hazardous drinking which were combined to get an alcohol involvement measure .
METHODS	Participants also completed three blocked format Stroop tasks , a control Stroop ( containing soft drink-related words ) , a general alcohol Stroop ( containing a mixture of alcohol-related words ) and an individualised Stroop that contained words relating to the participants ' favourite alcoholic drink .
RESULTS	Although there was no significant difference in participants ' performance across the three different Stroop tasks , only performance on the individualised Stroop was associated with alcohol involvement .
RESULTS	Notably , the individualised Stroop predicted variance in drinking after controlling for demographics and general alcohol Stroop performance .
CONCLUSIONS	This study indicates that adopting individualised stimuli into attentional bias tasks may increase their predictive validity .

###25440796
BACKGROUND	Following acute coronary syndrome ( ACS ) , the risk for future cardiovascular events is high and is related to levels of low-density lipoprotein cholesterol ( LDL-C ) even within the setting of intensive statin treatment .
BACKGROUND	Proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) regulates LDL receptor expression and circulating levels of LDL-C .
BACKGROUND	Antibodies to PCSK9 can produce substantial and sustained reductions of LDL-C .
BACKGROUND	The ODYSSEY Outcomes trial tests the hypothesis that treatment with alirocumab , a fully human monoclonal antibody to PCSK9 , improves cardiovascular outcomes after ACS .
METHODS	This Phase 3 study will randomize approximately 18,000 patients to receive biweekly injections of alirocumab ( 75-150 mg ) or matching placebo beginning 1 to 12 months after an index hospitalization for acute myocardial infarction or unstable angina .
METHODS	Qualifying patients are treated with atorvastatin 40 or 80 mg daily , rosuvastatin 20 or 40 mg daily , or the maximum tolerated and approved dose of one of these agents and fulfill one of the following criteria : LDL-C 70 mg/dL , non-high-density lipoprotein cholesterol 100 mg/dL , or apolipoprotein B 80 mg/dL .
METHODS	The primary efficacy measure is time to first occurrence of coronary heart disease death , acute myocardial infarction , hospitalization for unstable angina , or ischemic stroke .
METHODS	The trial is expected to continue until 1613 primary end point events have occurred with minimum follow-up of at least 2 years , providing 90 % power to detect a 15 % hazard reduction .
METHODS	Adverse events of special interest include allergic events and injection site reactions .
METHODS	Interim analyses are planned when approximately 50 % and 75 % of the targeted number of primary end points have occurred .
CONCLUSIONS	ODYSSEY Outcomes will determine whether the addition of the PCSK9 antibody alirocumab to intensive statin therapy reduces cardiovascular morbidity and mortality after ACS .

###25926413
BACKGROUND	Intrauterine growth restriction may be reduced by supplementing maternal diets during pregnancy , but few studies have assessed the impact of combined prenatal and postnatal interventions on child growth .
OBJECTIVE	We tested a hypothesis that provision of small-quantity lipid-based nutrient supplements ( SQ-LNSs ) to mothers in pregnancy and 6 mo postpartum and to their infants from 6 to 18 mo of age would promote infant and child growth in the study area in rural Malawi .
METHODS	We enrolled 869 pregnant women in a randomized trial in Malawi .
METHODS	During pregnancy and 6 mo thereafter , the women received daily 1 capsule of iron-folic acid ( IFA ) , 1 capsule containing 18 micronutrients ( MMN ) , or one 20-g sachet of SQ-LNS [ lipid-based nutrient supplements ( LNS ) , containing 21 MMN , protein , carbohydrates , essential fatty acids , and 118 kcal ] .
METHODS	Children in the IFA and MMN groups received no supplementation ; children in the LNS group received SQ-LNSs from 6 to 18 mo. .
METHODS	Primary outcome was child length at 18 mo. .
RESULTS	At 18 mo , the mean length in the IFA , MMN , and LNS groups was 77.0 , 76.9 , and 76.8 cm ( P = 0.90 ) , respectively , and the prevalence of stunting was 32.7 % , 35.6 % , and 37.9 % ( P = 0.54 ) , respectively .
RESULTS	No intergroup differences were found in the mean weight , head circumference , or midupper arm circumference or the proportions with low z scores for these variables ( P > 0.05 ) .
RESULTS	Covariate adjustment did not change the analysis results , and the associations between the intervention and child length were not modified by maternal parity , age , or nutritional status ( P > 0.10 ) .
CONCLUSIONS	The findings do not support a hypothesis that provision of SQ-LNSs to women in pregnancy and postpartum and to children from 6 to 18 mo of age would promote child growth in this Malawian study area .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01239693 .

###25265770
BACKGROUND	Femoral nerve block ( FNB ) with varying concentrations of bupivacaine is often used for postoperative analgesia after anterior cruciate ligament ( ACL ) reconstruction .
OBJECTIVE	To determine whether FNB using 0.25 % or 0.5 % bupivacaine provided better analgesia with less effect on quadriceps strengths after ACL reconstruction .
METHODS	One hundred patients were randomized to receive FNB with 20 mL of 0.25 % or 0.5 % bupivacaine .
METHODS	Data regarding demographic , effectiveness of FNB , time to first pain , time to first analgesic , pain scores , morphine use , and recovery of sensory and motor function were recorded .
RESULTS	Median time to first morphine requirement was 12 hours in 0.5 % bupivacaine group and 10 hours in 0.25 % bupivacaine group ( p = 0.048 ) .
RESULTS	Pain score at 18 hours was lower in 0.5 % bupivacaine group compared with 0.25 % bupivacaine group ( p = 0.001 ) .
RESULTS	When specify to the patellar tendon graft subgroup , the patients requiring morphine were 70 % in 0.5 % bupivacaine group and 90 % in 0.25 % bupivacaine group ( p = 0.03 ) .
RESULTS	No differences were found in demographic data , effectiveness of FNB , time to first pain , morphine consumption , and recovery of sensorimotor function .
CONCLUSIONS	FNB with 0.5 % bupivacaine provided longer time to first analgesic and lower narcotic requirements after patellar tendon graft ACL reconstruction when compared to 0.25 % bupivacaine .
CONCLUSIONS	Both concentrations showed similar effect on quadriceps strengths .

###25908281
OBJECTIVE	To establish a preoperative deep venous thrombosis predictor score for patients with fresh lower extremity fractures by statistical analysis .
METHODS	From January 2011 to December 2012 , 1 705 patients with fresh lower extremity fractures were admitted to department of orthopaedic trauma , Beijing Jishuitan Hospital .
METHODS	They were randomly divided into two groups , the group 1 ( n = 879 ) was used to screen risk factors and derived a predictive models based on logistic regression , the group 2 ( n = 826 ) validated the models .
RESULTS	Among the patients , there were 1 106 male and 599 female patients , with an average age of ( 50 18 ) years.Variables related to preoperative deep venous thrombosis were age , length of time before surgery , cause of injury , low/high-energy injury , location of injury , history of cardiovascular and cerebrovascular diseases , and D-Dimer .
RESULTS	The scores based on OR were : age 35 years : 1 point , > 35 - < 65 years : 4 points , 65 years : 6 points ; length of time before surgery , < 8 days :1 point , 8 days :2 points ; low-energy injury :1 point , high energy injury :3 points ; location of injury , foot and ankle :1 point , calf :3 points , around the knee : 5 points , femoral diaphysis and proximal femur :7 points , pelvis and acetabulum :4 points , 2 sites :6 point ; history of cardiovascular and cerebrovascular diseases , yes :2 points , no :1 point .
RESULTS	D-Dimer < 600 g/L :1 point , 600 g/L :3 points .
RESULTS	Area under receiver operating characteristic curve was 0.79 , critical point 15.5 points , sensitivity was 77.00 % , specificity was 68.17 % .
CONCLUSIONS	The score can predict the preoperative deep venous thrombosis for patients with fresh lower extremity fractures , but limited .

###24342265
OBJECTIVE	To investigate if baseline depression moderated response to Media Smart , an 8-lesson school-based program previously found to achieve a long-term risk reduction effect in young adolescents .
METHODS	540 Grade 8 students ( M age = 13.62 years , SD = .37 ) from 4 schools participated with 11 classes receiving the Media Smart program ( 126 girls ; 107 boys ) and 13 comparison classes receiving their normal lessons ( 147 girls ; 160 boys ) .
METHODS	Shape and weight concern , media internalization , body dissatisfaction , dieting , ineffectiveness , and perceived pressure were the outcome variables .
RESULTS	Moderation was indicated by significant interaction effects for group ( Media Smart ; Control ) moderator ( high depression ; low depression ) time ( post-program ; 6-month follow-up ; 2.5-year follow-up ) , with baseline entered as a covariate .
RESULTS	Such effects were found for shape and weight concern , media internalization , body dissatisfaction , ineffectiveness and perceived pressure .
RESULTS	Post-hoc testing found high depression Media Smart participants scored significantly lower than their control counterparts at post-program on shape and weight concern , media internalization and dieting , whereas low depression Media Smart participants scored significantly lower on shape and weight concern at 2.5-year follow-up .
CONCLUSIONS	Media Smart achieved a reduction in eating disorder risk factors for high-depression participants and a reduced rate of growth in risk factor scores for low-depression participants .
CONCLUSIONS	Trial registry name : Australian New Zealand Clinical Trials Registry .
CONCLUSIONS	URL : http://www.anzctr.org.au .
CONCLUSIONS	Registration identification number : ACTRN12608000545369 .

###24824900
OBJECTIVE	The purpose of this study was to determine the effects of early outpatient exercise on muscle mass , function , and fractional synthetic rate in severely burned children .
METHODS	Forty-seven children with 40 % total body surface area burn performed a 12-wk standard of care rehabilitation ( SOC , n = 23 ) or rehabilitative exercise training ( RET , n = 24 ) immediately after hospital discharge .
METHODS	Dual-energy x-ray absorptiometry was used to assess lean body mass ( LBM ) at discharge , posttreatment , and 12 months post-burn .
METHODS	Muscle function was evaluated with a Biodex Isokinetic Dynamometer , and peak aerobic fitness ( VO2peak ) was measured using a modified Bruce treadmill protocol posttreatment .
METHODS	Stable isotope infusion studies were performed in a subset of patients ( SOC , n = 13 ; RET , n = 11 ) at discharge and posttreatment to determine mixed-muscle fractional synthetic rate .
RESULTS	Relative peak torque ( RET , 138 9 Nmkg , vs SOC , 106 9 Nmkg ) and VO2peak ( RET , 32 1 mLkgmin , vs SOC , 28 1 mLkgmin ) were greater at posttreatment with RET compared with those with SOC .
RESULTS	In addition , RET increased whole-body ( 9 % 2 % ) and leg ( 17 % 3 % ) LBM compared with SOC .
RESULTS	Furthermore , the percentage change in whole-body ( 18 % 3 % ) and leg ( 31 % 4 % ) LBM from discharge to 12 months post-burn was greater with RET compared to SOC .
RESULTS	Muscle fractional synthetic rate decreased from discharge to posttreatment in both groups ( 6.9 % 1.1 % per day vs 3.4 0.4 % per day ) ; however , no differences were observed between treatment groups at each time point .
CONCLUSIONS	Early outpatient exercise training implemented at hospital discharge represents an effective intervention to improve muscle mass and function after severe burn injury .

###24425420
BACKGROUND	This study compared generalized complex fractionated atrial electrograms ( CFAE ) ablation versus a selective CFAE ablation strategy targeting areas of continuous electric activity .
RESULTS	Subjects with symptomatic , persistent/high-burden paroxysmal atrial fibrillation ( AF ) were enrolled at 6 centers ( n = 86 ) and randomized to 1 of 2 arms .
RESULTS	For group I , all CFAE regions with an interval confidence level > 7 were ablated followed by pulmonary vein isolation ( PVI ) .
RESULTS	For group II , only CFAE sites with continuous electric activity were ablated followed by PVI .
RESULTS	For PVI , all 4 PV antra were isolated with confirmed entrance block .
RESULTS	Subjects were followed for 1 year with a visit , ECG , and 48-hour Holter every 3 months .
RESULTS	Symptoms were confirmed by loop recording .
RESULTS	The primary end point was freedom from arrhythmia > 30 seconds at 1 year .
RESULTS	For both group I and II , CFAE ablation prolonged AF cycle length ( 2533 versus 2333 ms ; P = 0.78 ) and resulted in similar rates of AF termination ( 37 % versus 28 % ; P = 0.42 ) .
RESULTS	Radiofrequency duration during CFAE ablation was significantly less in group II ( 2320 versus 3820 minutes ; P = 0.002 ) .
RESULTS	At 1-year follow-up , freedom from AF/atrial flutter/atrial tachycardia recurrence was significantly higher in group I versus group II after 1 procedure ( 50 % versus 28 % ; P = 0.03 ) .
RESULTS	There were also significantly fewer repeat procedures in group I ( 13 % versus 36 % ; P = 0.021 ) .
CONCLUSIONS	Continuous electric activity ablation + PVI result in a similar incidence of acute AF termination with significantly less radiofrequency time .
CONCLUSIONS	However , incidence of repeat procedures and long-term recurrence of AF/atrial flutter/atrial tachycardia are significantly lower using generalized CFAE ablation + PVI .
CONCLUSIONS	Clinical Trial Registration - URL : http://www.clinicaltrials.gov .
CONCLUSIONS	Unique identifier : NCT00926783 .

###24262684
OBJECTIVE	To determine if the use of a Bakri balloon at cesarean delivery ( CD ) for placenta previa is associated with a reduced need for additional surgical or pharmacologic measures and less blood loss than usual practices .
METHODS	In a randomized controlled trial , 52 women undergoing CD for placenta previa were randomly allocated 1:1 into an intervention arm ( prophylactic Bakri balloon immediately following placental delivery ) or a control arm ( use of any usual surgical/pharmacologic measures to achieve hemostasis ) .
METHODS	The primary outcomes were a clinician 's decision to undertake further intervention to control bleeding , and the difference between preoperative and postoperative hemoglobin levels .
RESULTS	Although fewer women in the intervention group required additional measures to achieve hemostasis during CD , the difference between the groups was not significant ( relative risk 0.54 ; 95 % confidence interval , 0.19-1 .57 ) .
RESULTS	The change in hemoglobin level among women in the intervention arm was also similar to that among controls ( 2.3 g/dL ; 95 % confidence interval , -4.4 to 8.9 ) .
CONCLUSIONS	The prophylactic use of a Bakri balloon at CD for placenta previa tended to be of benefit , with no evidence of harm or patient dissatisfaction , but the need for additional medical/surgical measures to control blood loss was not significantly reduced .
CONCLUSIONS	Australian New Zealand Clinical Trials Registry : ACTRN12613000348752 .

###24439980
BACKGROUND	Exercise training is recommended for chronic heart failure ( HF ) patients to improve functional status and reduce risk of adverse outcomes .
BACKGROUND	Elevated plasma levels of amino-terminal pro-brain natriuretic peptide ( NT-proBNP ) , high-sensitivity C-reactive protein ( hs-CRP ) , and cardiac troponin T ( cTnT ) are associated with increased risk of adverse outcomes in this patient population .
BACKGROUND	Whether exercise training leads to improvements in biomarkers and how such improvements relate to clinical outcomes are unclear .
RESULTS	Amino-terminal pro-brain natriuretic peptide , hs-CRP , and cTnT levels were assessed at baseline and 3 months in a cohort of 928 subjects from the HF-ACTION study , a randomized clinical trial of exercise training versus usual care in chronic HF patients with reduced left ventricular ejection fraction ( < 35 % ) .
RESULTS	Linear and logistic regressions were used to assess 3-month biomarker levels as a function of baseline value , treatment assignment ( exercise training vs usual care ) , and volume of exercise .
RESULTS	Linear regression and Cox proportional hazard modeling were used to evaluate the relations between changes in biomarker levels and clinical outcomes of interest that included change in peak oxygen consumption ( peak VO2 ) , hospitalizations , and mortality .
RESULTS	Exercise training was not associated with significant changes in levels of NT-proBNP ( P = .10 ) , hs-CRP ( P = .80 ) , or detectable cTnT levels ( P = .83 ) at 3 months .
RESULTS	Controlling for baseline biomarker levels or volume of exercise did not alter these findings .
RESULTS	Decreases in plasma concentrations of NT-proBNP , but not hs-CRP or cTnT , were associated with increases in peak VO2 ( P < .001 ) at 3 months and decreased risk of hospitalizations or mortality ( P .04 ) , even after adjustment for a comprehensive set of known predictors .
CONCLUSIONS	Exercise training did not lead to meaningful changes in biomarkers of myocardial stress , inflammation , or necrosis in patients with chronic HF .
CONCLUSIONS	Only improvements in NT-proBNP translated to reductions in peak VO2 and reduced risk of clinical events .

###25411289
BACKGROUND	Biofortification is a strategy to relieve vitamin A ( VA ) deficiency .
BACKGROUND	Biofortified maize contains enhanced provitamin A concentrations and has been bioefficacious in animal and small human studies .
OBJECTIVE	The study sought to determine changes in total body reserves ( TBRs ) of vitamin A with consumption of biofortified maize .
METHODS	A randomized , placebo-controlled biofortified maize efficacy trial was conducted in 140 rural Zambian children .
METHODS	The paired ( 13 ) C-retinol isotope dilution test , a sensitive biomarker for VA status , was used to measure TBRs before and after a 90-d intervention .
METHODS	Treatments were white maize with placebo oil ( VA - ) , orange maize with placebo ( orange ) , and white maize with VA in oil [ 400 g retinol activity equivalents ( RAEs ) in 214 L daily ] ( VA + ) .
RESULTS	In total , 133 children completed the trial and were analyzed for TBRs ( n = 44 or 45/group ) .
RESULTS	Change in TBR residuals were not normally distributed ( P < 0.0001 ) ; median changes ( 95 % CI ) were as follows : VA - , 13 ( -19 , 44 ) mol ; orange , 84 ( 21 , 146 ) mol ; and VA + , 98 ( 24 , 171 ) mol .
RESULTS	Nonparametric analysis showed no statistical difference between VA + and orange ( P = 0.34 ) ; both were higher than VA - ( P = 0.0034 ) .
RESULTS	Median ( 95 % CI ) calculated liver reserves at baseline were 1.04 ( 0.97 , 1.12 ) mol/g liver , with 59 % > 1 mol/g , the subtoxicity cutoff ; none were < 0.1 mol/g , the deficiency cutoff .
RESULTS	The calculated bioconversion factor was 10.4 g - carotene equivalents/1 g retinol by using the middle 3 quintiles of change in TBRs from each group .
RESULTS	Serum retinol did not change in response to intervention ( P = 0.16 ) but was reduced with elevated C-reactive protein ( P = 0.0029 ) and -1 - acid glycoprotein ( P = 0.0023 ) at baseline .
CONCLUSIONS	- Carotene from maize was efficacious when consumed as a staple food in this population and could avoid the potential for hypervitaminosis A that was observed with the use of preformed VA from supplementation and fortification .
CONCLUSIONS	Use of more sensitive methods other than serum retinol alone , such as isotope dilution , is required to accurately assess VA status , evaluate interventions , and investigate the interaction of VA status and infection .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01814891 .

###24224521
BACKGROUND	Submassive pulmonary embolism ( PE ) has a low mortality rate but can degrade functional capacity .
OBJECTIVE	The present study aims to provide rationale , methodology , and initial findings of a multicentre , randomised trial of fibrinolysis for PE that used a composite end-point , including quality of life measures .
METHODS	This investigator-initiated study was funded by a contract between a corporate partner and the investigator 's hospital ( the prime site ) .
METHODS	The investigator was the Food and Drug Administration ( FDA ) sponsor .
METHODS	The prime site subcontracted , indemnified , and trained consortia members .
METHODS	Consenting , normotensive patients with PE and right ventricular strain ( by echocardiography or biomarkers ) received low-molecular-weight heparin and random assignment to a single bolus of tenecteplase or placebo in double-blinded fashion .
METHODS	The outcomes were : ( i ) in-hospital rate of intubation , vasopressor support , and major haemorrhage , or ( ii ) at 90 days , death , recurrent PE , or composite that defined poor quality of life ( echocardiography , 6 min walk test and surveys ) .
METHODS	The planned sample size was n = 200 .
RESULTS	Eight sites enrolled 87 patients over 5 years .
RESULTS	The ratio of patients screened for each enrolled was 7.4 to 1 , equating to 11 h screening time per patient enrolled .
RESULTS	Primary barrier to enrolment was the cost of screening .
RESULTS	Two patients died ( 2.5 % , 95 % CI [ 0-8 % ] ) , one developed shock , but 18 ( 22 % , 95 % CI : [ 13-30 % ] ) had a poor quality of life .
CONCLUSIONS	An investigator-initiated , FDA-regulated , multicentre trial of fibrinolysis for submassive PE was conducted , but was limited by screening costs and a low mortality rate .
CONCLUSIONS	Quality of life measurements might represent a more important patient-centred end-point .

###25082132
BACKGROUND	Crashes are the leading cause of death for teens , and parent-based interventions are a promising approach .
BACKGROUND	We assess the effectiveness of Steering Teens Safe , a parent-focused program to increase safe teen driving .
METHODS	Steering Teens Safe aimed to improve parental communication with teens about safe driving using motivational interviewing techniques in conjunction with 19 safe driving lessons .
METHODS	A randomized controlled trial involved 145 parent-teen dyads ( 70 intervention and 75 control ) .
METHODS	Intervention parents received a 45-minute session to learn the program with four follow-up phone sessions , a DVD , and a workbook .
METHODS	Control parents received a standard brochure about safe driving .
METHODS	Scores were developed to measure teen-reported quantity and quality of parental communication about safe driving .
METHODS	The main outcome measure was a previously validated Risky Driving Score reported by teens .
METHODS	Because the Score was highly skewed , a generalized linear model based on a gamma distribution was used for analysis .
RESULTS	Intervention teens ranked their parent 's success in talking about driving safety higher than control teens ( p = 0.035 ) and reported that their parents talked about more topics ( non-significant difference ) .
RESULTS	The Risky Driving Score was 21 % lower in intervention compared to control teens ( 85 % CI = 0.60 , 1.00 ) .
RESULTS	Interaction between communication quantity and the intervention was examined .
RESULTS	Intervention teens who reported more successful communication had a 42 % lower Risky Driving Score ( 95 % CI = 0.37 , 0.94 ) than control parents with less successful communication .
CONCLUSIONS	This program had a positive although not strong effect , and it may hold the most promise in partnership with other programs , such as Driver 's Education or Graduated Driver 's License policies .
BACKGROUND	ClinicalTrials.gov NCT01014923 .
BACKGROUND	Registered Nov. 16 , 2009 .

###24297946
OBJECTIVE	Deep molecular response ( MR ( 4.5 ) ) defines a subgroup of patients with chronic myeloid leukemia ( CML ) who may stay in unmaintained remission after treatment discontinuation .
OBJECTIVE	It is unclear how many patients achieve MR ( 4.5 ) under different treatment modalities and whether MR ( 4.5 ) predicts survival .
METHODS	Patients from the randomized CML-Study IV were analyzed for confirmed MR ( 4.5 ) which was defined as 4.5 log reduction of BCR-ABL on the international scale ( IS ) and determined by reverse transcriptase polymerase chain reaction in two consecutive analyses .
METHODS	Landmark analyses were performed to assess the impact of MR ( 4.5 ) on survival .
RESULTS	Of 1,551 randomly assigned patients , 1,524 were assessable .
RESULTS	After a median observation time of 67.5 months , 5-year overall survival ( OS ) was 90 % , 5-year progression-free-survival was 87.5 % , and 8-year OS was 86 % .
RESULTS	The cumulative incidence of MR ( 4.5 ) after 9 years was 70 % ( median , 4.9 years ) ; confirmed MR ( 4.5 ) was 54 % .
RESULTS	MR ( 4.5 ) was reached more quickly with optimized high-dose imatinib than with imatinib 400 mg/day ( P = .016 ) .
RESULTS	Independent of treatment approach , confirmed MR ( 4.5 ) at 4 years predicted significantly higher survival probabilities than 0.1 % to 1 % IS , which corresponds to complete cytogenetic remission ( 8-year OS , 92 % v 83 % ; P = .047 ) .
RESULTS	High-dose imatinib and early major molecular remission predicted MR ( 4.5 ) .
RESULTS	No patient with confirmed MR ( 4.5 ) has experienced progression .
CONCLUSIONS	MR ( 4.5 ) is a new molecular predictor of long-term outcome , is reached by a majority of patients treated with imatinib , and is achieved more quickly with optimized high-dose imatinib , which may provide an improved therapeutic basis for treatment discontinuation in CML .

###25590323
OBJECTIVE	To compare the efficacy and safety of endoscopic dacryocystorhinostomy ( En-DCR ) with different stent materials for lacrimal sac intubation in primary nasolacrimal ductal obstructions .
METHODS	Randomized controlled study with three parallel groups .
METHODS	Level of evidence is 1b .
METHODS	A total of 91 patients ( five bilateral ) with primary nasolacrimal duct obstruction ( NLDO ) at a tertiary referral center scheduled for En-DCR were to allocated into three stent groups with a sealed envelope and were randomized into three treatments : silicone , Prolene ( polypropylene ) , and otologic T-tube .
METHODS	Ophthalmology and otolaryngology clinics evaluated the patients preoperatively and postoperatively with endoscopes , lacrimal system syringing , and dacryocystography .
METHODS	The success of the stents was evaluated 12 months after surgery with symptom relief and ostial patency .
METHODS	Complications were also noted .
RESULTS	The overall success rate of the En-DCR in the stent groups was 78.1 % ( 75/96 ) ; specifically , 87.5 % ( 28/32 ) with silicone , 84.4 % ( 27/32 ) with Prolene , and 62.5 % ( 20/32 ) with T-tube .
RESULTS	The efficacy of the procedures with the T-tube was significantly lower than that of the Prolene and silicone ( p = .031 , ( 2 ) test ) .
RESULTS	There were no significant differences between the silicone and Prolene ( p = .718 , ( 2 ) test ) .
RESULTS	Prolene was found to be related with orbital complications .
RESULTS	Spontaneous loss is a particular complication of otologic T-tube and highly portends to failure .
CONCLUSIONS	The results of our study suggest that efficacy , defined as anatomic and functional success , is equally high for silicone and Prolene stents and lower for otologic T-tube in En-DCR .

###24751304
BACKGROUND	Little is known about the longer-term effects of adjunctive benzodiazepines on symptom response during treatment in patients with bipolar disorders .
METHODS	The study sample consisted of 482 patients with bipolar I or II disorder enrolled in a 6-month , randomized , multi-site comparison of lithium - and quetiapine-based treatment .
METHODS	Changes in clinical measures ( BISS total and subscales , CGI-BP , and CGI-Efficacy Index ) were compared between participants who did and did not receive benzodiazepine treatment at baseline or during follow-up .
METHODS	Selected outcomes were also compared between patients who did and did not initiate benzodiazepines during follow-up using stabilized inverse probability weighted analyses .
RESULTS	Significant improvement in all outcome measures occurred within each benzodiazepine exposure group .
RESULTS	Benzodiazepine users ( at baseline or during follow-up ) experienced significantly less improvement in BISS total , BISS irritability , and CGI-BP scores than did benzodiazepine non-users .
RESULTS	There were no significant differences in these measures between patients who did and did not initiate benzodiazepines during follow-up in the weighted analyses .
RESULTS	There was no significant effect of benzodiazepine use on any outcome measure in patients with comorbid anxiety or substance use disorders .
CONCLUSIONS	This is a secondary analysis of data from a randomized effectiveness trial that was not designed to address differential treatment response according to benzodiazepine use .
CONCLUSIONS	Adjunctive benzodiazepines may not significantly affect clinical outcome in lithium - or quetiapine-treated patients with bipolar I or II disorder over 6 months , after controlling for potential confounding factors .

###25531162
BACKGROUND	Most patients with diabetic kidney disease ( DKD ) experience disease progression despite receiving standard care therapy .
BACKGROUND	Oxidative stress is associated with DKD severity and risk of progression , but currently approved therapies do not directly attenuate the pathologic consequences of oxidative stress .
BACKGROUND	GS-4997 is a once daily , oral molecule that inhibits Apoptosis Signal-regulating Kinase 1 ( ASK1 ) , which is a key mediator of the deleterious effects of oxidative stress .
METHODS	We describe the rationale and design of a Phase 2 placebo-controlled clinical trial investigating the effects of GS-4997 in patients with T2DM and stage 3/4 DKD receiving standard of care therapy .
METHODS	Approximately , 300 subjects will be randomized in a stratified manner , based on the estimated glomerular filtration rate ( eGFR ) and urine albumin to creatinine ratio , to one of four arms in this dose-ranging study .
METHODS	The primary endpoint is change in eGFR at 48 weeks , and the key secondary endpoint is change in albuminuria .
CONCLUSIONS	Guided by the biology of oxidative stress signaling through ASK1 , the biology of DKD pathogenesis , and solid statistical methods , the decisions made for this Phase 2 study regarding delineating study population , efficacy outcomes , treatment period and statistical methods represent innovative attempts to resolve challenges specific to DKD study design .

###24885317
BACKGROUND	Adherence to medication is often low .
BACKGROUND	Pharmacists may improve adherence , but a one-size-fits-all approach will not work : different patients have different needs .
BACKGROUND	Goal of the current study is to assess the effectiveness of a patient-tailored , telephone-based intervention by a pharmacist at the start of pharmacotherapy aimed at improving medication adherence , satisfaction with information and counselling and the beliefs about medicines .
METHODS	A cluster randomized controlled intervention trial in 30 Dutch pharmacies , randomly assigned to 1 of 2 intervention groups .
METHODS	Each group consists of an intervention arm and an usual care arm .
METHODS	The intervention arm in the first group is the usual care arm in the second group and vice versa .
METHODS	One intervention arm focuses on patients starting with antidepressants or bisphosphonates and the other on antilipaemic drugs or renin angiotensin system ( RAS ) - inhibitors .
METHODS	The intervention consists of a telephone call by a pharmacist 2 or 3 weeks after a new prescription .
METHODS	A random sample of pharmacies will send questionnaires 3 months after the first prescription .
METHODS	This contains socio-demographic questions , a measure of beliefs about medicines ( BMQ ) , satisfaction with information received ( SIMS , abbreviated ) and frequency of pharmacy counselling ( Consumer Quality Index , CQI , abbreviated ) .
METHODS	The primary outcome measure will be medication adherence calculated from dispensing records retrieved 12 months after the intervention .
METHODS	Patients ' beliefs on medication , perception of the quality of information received and pharmacy counselling are secondary outcomes .
CONCLUSIONS	The TelCIP study will determine the effectiveness of telephone counselling to improve adherence in patients initiating a new treatment .
CONCLUSIONS	By measuring satisfaction with information and counselling and beliefs about medication the study will also give clues for the reason of a potential increase in adherence .
CONCLUSIONS	Finally the study will provide information on which patients are most likely to benefit from this intervention .
BACKGROUND	The trial is registered at http://www.trialregister.nl under the identifier NTR3237 .

###25141094
OBJECTIVE	The purpose of this study was to examine the effects of including female athletes ' weights in athletic event programs on female spectators ' body image , eating disorder symptoms , self-esteem , and affective state and to investigate whether the magnitude of the athletes ' reported weights had differential effects on female spectators ( i.e. , do female spectators who view heavier athletes respond differently than those who view less heavy athletes ? )
METHODS	We used an experimental design to examine hypotheses derived from competing theories to determine whether exposure to female athletes of varying weight would adversely or beneficially impact female undergraduates ( N = 152 ) who served as athletic event spectators .
RESULTS	Analyses indicated that in this simulated study , female spectators ' body image , eating disorder symptoms , self-esteem , and affective states were not impacted by the presence or by the magnitude of female athletes ' weights in athletic event programs .
CONCLUSIONS	The results imply that including athletes ' weights in game-day programs at women 's athletic events does not affect female spectators on an individual level .

###24484541
BACKGROUND	Approximately 20 % of patients are not satisfied with the outcome of total knee replacement , great volumes of which are carried out yearly .
BACKGROUND	Physiotherapy is often provided by the NHS to address dysfunction following knee replacement ; however the efficacy of this is unknown .
BACKGROUND	Although clinically it is accepted that therapy is useful , provision of physiotherapy to all patients post-operatively does not enhance outcomes at one year .
BACKGROUND	No study has previously assessed the effect of targeting therapy to individuals struggling to recover in the early post-operative phase.The aim of the TRIO study is to determine whether stratifying care by targeting physiotherapy to those individuals performing poorly following knee replacement is effective in improving the one year outcomes .
BACKGROUND	We are also investigating whether the structure of the physiotherapy provision itself influences outcomes .
METHODS	The study is a multi-centre prospective randomised controlled trial ( RCT ) of patients undergoing primary total knee replacement , with treatment targeted at those deemed most susceptible to gain from it .
METHODS	Use of the national PROMS programme for pre-operative data collection allows us to screen all patients at initial post-operative clinical review , and recruit only those deemed to be recovering slowly.We aim to recruit 440 patients through various NHS orthopaedic centres who will undergo six weeks of physiotherapy .
METHODS	The intervention will be either ` intensive ' involving both hospital and home-based functional exercise rehabilitation , or ` standard of care ' consisting of home exercises .
METHODS	Patients will be randomised to either group using a web-based system .
METHODS	Both groups will receive pre and post-intervention physiotherapy review .
METHODS	Patients will be followed-up to one year post-operation .
METHODS	The primary outcome measure is the Oxford Knee Score .
METHODS	Secondary outcomes are patient satisfaction , functional ability , pain scores and cost-effectiveness .
BACKGROUND	Current Controlled Trials ISRCTN23357609 .
BACKGROUND	ClinicalTrials.gov NCT01849445 .

###26296950
BACKGROUND	In developing countries , mortality in children with very severe pneumonia is high , even with the provision of appropriate antibiotics , standard oxygen therapy , and other supportive care .
BACKGROUND	We assessed whether oxygen therapy delivered by bubble continuous positive airway pressure ( CPAP ) improved outcomes compared with standard low-flow and high-flow oxygen therapies .
METHODS	This open , randomised , controlled trial took place in Dhaka Hospital of the International Centre for Diarrhoeal Disease Research , Bangladesh .
METHODS	We randomly assigned children younger than 5 years with severe pneumonia and hypoxaemia to receive oxygen therapy by either bubble CPAP ( 5 L/min starting at a CPAP level of 5 cm H2O ) , standard low-flow nasal cannula ( 2 L/min ) , or high-flow nasal cannula ( 2 L/kg per min up to the maximum of 12 L/min ) .
METHODS	Randomisation was done with use of the permuted block methods ( block size of 15 patients ) and Fisher and Yates tables of random permutations .
METHODS	The primary outcome was treatment failure ( ie , clinical failure , intubation and mechanical ventilation , death , or termination of hospital stay against medical advice ) after more than 1 h of treatment .
METHODS	Primary and safety analyses were by intention to treat .
METHODS	We did two interim analyses and stopped the trial after the second interim analysis on Aug 3 , 2013 , as directed by the data safety and monitoring board .
METHODS	This trial is registered at ClinicalTrials.gov , number NCT01396759 .
RESULTS	Between Aug 4 , 2011 , and July 17 , 2013 , 225 eligible children were recruited .
RESULTS	We randomly allocated 79 ( 35 % ) children to receive oxygen therapy by bubble CPAP , 67 ( 30 % ) to low-flow oxygen therapy , and 79 ( 35 % ) to high-flow oxygen therapy .
RESULTS	Treatment failed for 31 ( 14 % ) children , of whom five ( 6 % ) had received bubble CPAP , 16 ( 24 % ) had received low-flow oxygen therapy , and ten ( 13 % ) had received high-flow oxygen therapy .
RESULTS	Significantly fewer children in the bubble CPAP group had treatment failure than in the low-flow oxygen therapy group ( relative risk [ RR ] 027 , 997 % CI 007-099 ; p = 00026 ) .
RESULTS	No difference in treatment failure was noted between patients in the bubble CPAP and those in the high-flow oxygen therapy group ( RR 050 , 997 % 011-229 ; p = 0175 ) .
RESULTS	23 ( 10 % ) children died .
RESULTS	Three ( 4 % ) children died in the bubble CPAP group , ten ( 15 % ) children died in the low-flow oxygen therapy group , and ten ( 13 % ) children died in the high-flow oxygen therapy group .
RESULTS	Children who received oxygen by bubble CPAP had significantly lower rates of death than the children who received oxygen by low-flow oxygen therapy ( RR 025 , 95 % CI 007-089 ; p = 0022 ) .
CONCLUSIONS	Oxygen therapy delivered by bubble CPAP improved outcomes in Bangladeshi children with very severe pneumonia and hypoxaemia compared with standard low-flow oxygen therapy .
CONCLUSIONS	Use of bubble CPAP oxygen therapy could have a large effect in hospitals in developing countries where the only respiratory support for severe childhood pneumonia and hypoxaemia is low-flow oxygen therapy .
CONCLUSIONS	The trial was stopped early because of higher mortality in the low-flow oxygen group than in the bubble CPAP group , and we acknowledge that the early cessation of the trial reduces the certainty of the findings .
CONCLUSIONS	Further research is needed to test the feasibility of scaling up bubble CPAP in district hospitals and to improve bubble CPAP delivery technology .
BACKGROUND	International Centre for Diarrhoeal Disease Research , Bangladesh , and Centre for International Child Health , University of Melbourne .

###24274431
BACKGROUND	Blood Pressure related disease affected 118 million people in India in the year 2000 ; this figure will double by 2025 .
BACKGROUND	Around one in four adults in rural India have hypertension , and of those , only a minority are accessing appropriate care .
BACKGROUND	Health systems in India face substantial challenges to meet these gaps in care , and innovative solutions are needed .
METHODS	We hypothesise that a multifaceted intervention involving capacity strengthening of primary healthcare doctors and non-physician healthcare workers through use of a mobile device-based clinical decision support system will result in improved blood pressure control for individuals at high risk of a cardiovascular disease event when compared with usual healthcare .
METHODS	This intervention will be implemented as a stepped wedge , cluster randomised controlled trial in 18 primary health centres and 54 villages in rural Andhra Pradesh involving adults aged 40 years at high cardiovascular disease event risk ( approximately 15,000 people ) .
METHODS	Cardiovascular disease event risk will be calculated based on World Health Organisation/International Society of Hypertension 's region-specific risk charts .
METHODS	Cluster randomisation will occur at the level of the primary health centres .
METHODS	Outcome analyses will be conducted blinded to intervention allocation .
OBJECTIVE	The primary study outcome is the difference in the proportion of people meeting guideline-recommended blood pressure targets in the intervention period vs. the control period .
OBJECTIVE	Secondary outcomes include mean reduction in blood pressure levels ; change in other cardiovascular disease risk factors , including body mass index , current smoking , reported healthy eating habits , and reported physical activity levels ; self-reported use of blood pressure and other cardiovascular medicines ; quality of life ( using the EQ-5D ) ; and cardiovascular disease events ( using hospitalisation data ) .
OBJECTIVE	Trial outcomes will be accompanied by detailed process and economic evaluations .
CONCLUSIONS	The findings are likely to inform policy on a scalable strategy to overcome entrenched inequities in access to effective healthcare for under-served populations in low and middle income country settings .
BACKGROUND	Clinical Trial Registry India CTRI/2013/06 / 003753 .

###25137845
OBJECTIVE	To observe the effect of external application of Zhuangshenling Recipe ( ZR ) combined with Western medicine ( WM ) on the heart function of chronic heart failure ( CHF ) patients of Xin-Shen yang deficiency , interior retention of water-fluid syndrome ( XSYDIRWFS ) .
METHODS	Totally 140 CHF patients of XSYDIRWFS were randomly assigned to two groups , the treatment group and the control group , 70 in each group .
METHODS	All patients received WM therapy .
METHODS	Those in the treatment group were applied with ZR at Xinshu ( BL15 ) and Shenshu ( BL23 ) , while those in the control group were applied with placebos at Xinshu ( BL15 ) and Shenshu ( BL23 ) .
METHODS	The therapeutic course for all was 12 weeks .
METHODS	The integrals of TCM syndrome , grading of cardiac function , brain natriuretic polypeptide ( BNP ) , and 6 min walking distance were observed before and after treatment .
RESULTS	After twelve weeks of treatment , the effective rate of improved grading of cardiac function , the total effective rate of TCM syndrome efficacy , and the BNP level were obviously better in the treatment group ( P < 0.05 ) .
RESULTS	There was no statistical difference in 6 min walking distance between the two groups ( P > 0.05 ) .
CONCLUSIONS	External application of ZR combined with WM could improve the heart function of CHF patients of XSYDIRWFS .

###24885942
BACKGROUND	High levels of circulating fibroblast growth factor 23 ( FGF23 ) are associated with chronic kidney disease ( CKD ) progression and high mortality .
BACKGROUND	In the Phosphate Reduction Evaluation of FGF23 in Early CKD Treatment ( PREFECT ) study , we assessed the effect of reducing intestinal phosphate absorption using lanthanum carbonate on FGF23 levels in normophosphatemic patients with CKD stage 3 .
METHODS	Thirty-five individuals were randomized to lanthanum carbonate 3000 mg/day ( n = 23 ) or placebo ( n = 12 ) for 12 weeks .
METHODS	Levels of intact FGF23 ( iFGF23 ) , C-terminal FGF23 , serum and urinary phosphate and calcium , intact parathyroid hormone and 1,25-dihydroxyvitamin D were assessed .
RESULTS	The median age was 65 years in the lanthanum group and 73 years in the placebo group ; 58.8 % and 41.7 % were men , respectively .
RESULTS	No significant difference was seen in mean iFGF23 between groups at week 12 .
RESULTS	There was , however , a transient reduction from baseline in iFGF23 in the lanthanum group at week 1 , from 70.5 pg/ml to 51.9 pg/ml , which was not seen in the placebo group ; this between-group difference in percentage change from baseline was significant in post hoc analyses ( p = 0.0102 ) .
RESULTS	Urinary phosphate decreased after 1 week of lanthanum treatment and remained low at week 12 .
CONCLUSIONS	Reducing intestinal phosphate absorption with lanthanum carbonate did not lead to sustained reductions in iFGF23 in patients with CKD stage 3 , although phosphaturia decreased .
CONCLUSIONS	This suggests that factors other than phosphate burden may be responsible for driving increases in circulating FGF23 in patients with CKD .
BACKGROUND	ClinicalTrials.gov NCT01128179 , 20 May 2010 .

###24412457
OBJECTIVE	This study sought to compare the efficacy of drug-eluting balloons ( DEB ) with that of everolimus-eluting stents ( EES ) in patients with bare-metal stents ( BMS ) in-stent restenosis ( ISR ) .
BACKGROUND	Treatment of patients with ISR remains a challenge .
METHODS	This was a prospective , multicenter , randomized trial comparing DEB with EES in patients with bare-metal stents ( BMS ) in-stent restenosis ( ISR ) .
METHODS	The primary endpoint was the minimal lumen diameter at 9 months ' follow-up .
RESULTS	A total of 189 patients with BMS-ISR from 25 Spanish sites were included ( 95 were allocated to DEB and 94 to EES ) .
RESULTS	Procedural success was achieved in all patients .
RESULTS	At late angiography ( median 249 days ; 92 % of eligible patients ) , patients in the EES arm had a significantly larger minimal lumen diameter ( 2.36 0.6 mm vs. 2.01 0.6 mm , p < 0.001 ; absolute mean difference : 0.35 mm ; 95 % confidence interval [ CI ] : 0.16 to 0.53 ) and a lower percent of diameter stenosis ( 13 17 % vs. 25 20 % , p < 0.001 ) .
RESULTS	However , late loss ( 0.04 0.5 mm vs. 0.14 0.5 mm , p = 0.14 ) and binary restenosis rate ( 4.7 % vs. 9.5 % , p = 0.22 ) were very low and similar in both groups .
RESULTS	Clinical follow-up ( median 365 days ) was obtained in all ( 100 % ) patients .
RESULTS	Occurrences of the combined clinical outcome measure ( cardiac death , myocardial infarction , and target vessel revascularization ; 6 % vs. 8 % ; hazard ratio [ HR ] : 0.76 ; 95 % CI : 0.26 to 2.18 , p = 0.6 ) and the need for target vessel revascularization ( 2 % vs. 6 % ; HR : 0.32 : 95 % CI : 0.07 to 1.59 , p = 0.17 ) were similar in the 2 groups .
CONCLUSIONS	In patients with BMS-ISR , both DEB and EES provided excellent clinical results with a very low rate of clinical and angiographic recurrences .
CONCLUSIONS	However , compared with DEB , EES provide superior late angiographic findings .
CONCLUSIONS	( Restenosis Intra-stent of Bare Metal Stents : Paclitaxel-eluting Balloon vs. Everolimus-eluting Stent [ RIBS V ] ; NCT01239953 ) .

###25367150
BACKGROUND	Irregularity measures have been suggested as risk indicators in patients with atrial fibrillation ( AF ) ; however , it is not known to what extent they are affected by commonly used rate-control drugs .
BACKGROUND	We aimed at evaluating the effect of metoprolol , carvedilol , diltiazem , and verapamil on the variability and irregularity of the ventricular response in patients with permanent AF .
RESULTS	Sixty patients with permanent AF were part of an investigator-blind cross-over study , comparing 4 rate-control drugs ( diltiazem , verapamil , metoprolol , and carvedilol ) .
RESULTS	We analyzed five 20-minute segments per patient : baseline and the 4 drug regimens .
RESULTS	On every segment , heart rate ( HR ) variability and irregularity of RR series were computed .
RESULTS	The variability was assessed as standard deviation , pNN20 , pNN50 , pNN80 , and rMSSD .
RESULTS	The irregularity was assessed by regularity index , approximate ( ApEn ) , and sample entropy .
RESULTS	A significantly lower HR was obtained with all drugs , the HR was lowest using the calcium channel blockers .
RESULTS	All drugs increased the variability of ventricular response in respect to baseline ( as an example , rMSSD : baseline 171 47 milliseconds , carvedilol 229 58 milliseconds ; P < 0.05 vs. baseline , metoprolol 226 66 milliseconds ; P < 0.05 vs. baseline , verapamil 228 84 ; P < 0.05 vs. baseline , diltiazem 256 87 milliseconds ; P < 0.05 vs. baseline and all other drugs ) .
RESULTS	Only - blockers significantly increased the irregularity of the RR series ( as an example , ApEn : baseline 1.86 0.13 , carvedilol 1.92 0.09 ; P < 0.05 vs. baseline , metoprolol 1.93 0.08 ; P < 0.05 vs. baseline , verapamil 1.86 0.22 ns , diltiazem 1.88 0.16 ns ) .
CONCLUSIONS	Modification of AV node conduction by rate-control drugs increase RR variability , while only - blockers affect irregularity .

###24793028
OBJECTIVE	Among patients with quiescent ulcerative colitis ( UC ) , lower fecal concentrations of calprotectin are associated with lower rates of relapse .
OBJECTIVE	We performed an open-label , randomized controlled trial to investigate whether increasing doses of mesalamine reduce concentrations of fecal calprotectin ( FC ) in patients with quiescent UC .
METHODS	We screened 119 patients with UC in remission on the basis of Simple Clinical Colitis Activity Index scores , FC > 50 g/g , and intake of no more than 3 g/day mesalamine .
METHODS	Participants taking mesalamine formulations other than multimatrix mesalamine were switched to multimatrix mesalamine ( 2.4 g/day ) for 6 weeks ; 52 participants were then randomly assigned ( 1:1 ) to a group that continued its current dose of mesalamine ( controls , n = 26 ) or a group that increased its dose by 2.4 g/day for 6 weeks ( n = 26 ) .
METHODS	The primary outcome was continued remission with FC < 50 g/g .
METHODS	Secondary outcomes were continued remission with FC < 100 g/g or < 200 g/g ( among patients with pre-randomization values above these levels ) .
RESULTS	The primary outcome was achieved by 3.8 % of controls and 26.9 % of the dose escalation group ( P = .0496 ) .
RESULTS	More patients in the dose escalation group reduced FC to below 100 g/g ( P = .04 ) and 200 g/g ( P = .005 ) .
RESULTS	Among the patients who were still in remission after the randomization phase , clinical relapse occurred sooner in patients with FC > 200 g/g compared with those with FC < 200 g/g ( P = .01 ) .
CONCLUSIONS	Among patients with quiescent UC and increased levels of FC , increasing the dose of mesalamine by 2.4 g/day reduced fecal concentrations of calprotectin to those associated with lower rates of relapse .
CONCLUSIONS	Clinicaltrials.gov number : NCT00652145 .

###26227186
BACKGROUND	Despite standard statin therapy , a majority of patients retain a high `` residual risk '' of cardiovascular events .
OBJECTIVE	The aim of this study was to evaluate the effects of ezetimibe plus atorvastatin versus atorvastatin monotherapy on the lipid profile and coronary atherosclerosis in Japanese patients who underwent percutaneous coronary intervention ( PCI ) .
METHODS	This trial was a prospective , randomized , controlled , multicenter study .
METHODS	Eligible patients who underwent PCI were randomly assigned to atorvastatin alone or atorvastatin plus ezetimibe ( 10 mg ) daily .
METHODS	Atorvastatin was uptitrated with a treatment goal of low-density lipoprotein cholesterol ( LDL-C ) < 70 mg/dl .
METHODS	Serial volumetric intravascular ultrasound was performed at baseline and again at 9 to 12 months to quantify the coronary plaque response in 202 patients .
RESULTS	The combination of atorvastatin/ezetimibe resulted in lower levels of LDL-C than atorvastatin monotherapy ( 63.2 16.3 mg/dl vs. 73.3 20.3 mg/dl ; p < 0.001 ) .
RESULTS	For the absolute change in percent atheroma volume ( PAV ) , themean difference between the 2 groups ( -1.538 % ; 95 % confidence interval [ CI ] : -3.079 % to 0.003 % ) did not exceedthe pre-defined noninferiority margin of 3 % , but the absolute change in PAV did show superiority for the dual lipid-lowering strategy ( -1.4 % ; 95 % CI : -3.4 % to -0.1 % vs. -0.3 % ; 95 % CI : -1.9 % to 0.9 % with atorvastatin alone ; p = 0.001 ) .
RESULTS	For PAV , a significantly greater percentage of patients who received atorvastatin/ezetimibe showed coronary plaque regression ( 78 % vs. 58 % ; p = 0.004 ) .
RESULTS	Both strategies had acceptable side effect profiles , with a low incidence oflaboratory abnormalities and cardiovascular events .
CONCLUSIONS	Compared with standard statin monotherapy , the combination of statin plus ezetimibe showed greater coronary plaque regression , which might be attributed to cholesterol absorption inhibition-induced aggressive lipid lowering .
CONCLUSIONS	( Plaque Regression With Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by Intravascular Ultrasound [ PRECISE-IVUS ] ; NCT01043380 ) .